eflective of bone turnover changes and not to metastases.
11990184|NCT00662103|Other|questionnaire administration|Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function.
11990185|NCT00662103|Other|survey administration|Administered at measured at baseline, 3, 6, 12, and 18 months
11990186|NCT00662103|Procedure|assessment of therapy complications|Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months )
11990187|NCT00662103|Procedure|fatigue assessment and management|The Schwartz Cancer Fatigue (SCF) scale, a 6-item scale that specifically assesses the level of subjective fatigue that the participant is currently experiencing. The SCF has been used to measure fatigue in previous exercise studies. The Piper Fatigue Scale (PFS) consists of 22 items and four subscales: behavioral/severity, affective meaning, sensory and cognitive/mood. The scale has been shown to detect reductions in fatigue in cancer patients undergoing behavioral interventions to reduce fatigue, including exercise. Responses are averaged for subscale and total scores with higher scores indicating more fatigue. The PFS has been used to measure fatigue in previous studies of illness and/or medical treatments. 15 minute survey
11990188|NCT00662103|Procedure|management of therapy complications|An interim safety/efficacy review will occur after the first half of enrolled participants completes their 3 month testing appointment (or after 3 months of exercise). The interim safety review will be overseen by OHSU NCI-designated Cancer Institute, while the efficacy review will be conducted by an independent monitor, Dr. George Knafl, a biostatistician in the OHSU School of Nursing, who is not a member of the study personnel.
11990189|NCT00662103|Procedure|psychosocial assessment and care|We will include a 6-item measure of self-efficacy for exercise that has been validated in adults (Nigg, 2002) and has been used by Dr. Bennett (Co-I) in current work in cancer survivors. 5 min. survey
11990190|NCT00662077|Drug|Ibandronate|Ibandronate endovenous 3 mg every 3 months
11990191|NCT00662077|Behavioral|Lifestyle modifications|Lifestyle modifications: counseling every 3 months
11990192|NCT00662038|Drug|pirfenidone|Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
11990193|NCT00662025|Drug|Capecitabine|Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
11990194|NCT00662025|Drug|Sunitinib|Sunitinib 37.5 mg daily, continuous dosing
11990195|NCT00662012|Drug|Sodium Stibogluconate (SSG)|100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
11990196|NCT00661999|Biological|darbepoetin alfa|Given by injection
11990197|NCT00661999|Dietary Supplement|ferrous sulfate|Given by mouth
11990198|NCT00661999|Drug|sodium ferric gluconate complex in sucrose|Given by IV
11990199|NCT00661999|Other|placebo|Given by mouth
11990200|NCT00661986|Dietary Supplement|dark chocolate 6 g/day|dark chocolate 6 g/day
11990201|NCT00661986|Dietary Supplement|dark chocolate 25 g/day|dark chocolate 25 g/day
11990202|NCT00661973|Drug|budesonide|inhaled budesonide (turbohaler) 400 micrograms twice a day for 4 weeks
11990203|NCT00661960|Drug|raltegravir|400mg tablet twice daily by mouth for nine months
11990204|NCT00661960|Drug|efavirenz|600mg capsule once daily by mouth without regard to food
11990205|NCT00661947|Other|Dr Pepper sweetened with sucrose or high fructose corn syrup|Comparison of different formulations of fructose.
11990206|NCT00661921|Biological|AMG 108|IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.
11990207|NCT00661921|Biological|Placebo|AMG 108 volume matching placebo
11990208|NCT00661895|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25 mg tablets
11990209|NCT00661895|Drug|Lisinopril|Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet
11990210|NCT00661895|Drug|Lisinopril and Hydrochlorothiazide|L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets
11990211|NCT00661895|Drug|Nifedipine XL|30 mg extended release tablets, 60 mg extended release tablets
11990212|NCT00661895|Drug|Metoprolol tartrate|50 mg tablets & 100 mg tablets
11990213|NCT00661895|Drug|Atenolol|50 mg tablet
11990214|NCT00661895|Drug|Valsartan|80 mg tablets & 160 mg tablet
11990215|NCT00661895|Drug|Doxazosin|4 mg tablets
11990216|NCT00661895|Drug|Clonidine|0.2 mg tablets
11990217|NCT00661895|Drug|Hydralazine|50 mg tablets
11990218|NCT00661895|Drug|Metoprolol succinate|50 mg tablet & 100 mg tablet
11990219|NCT00661895|Drug|Amlodipine|5 mg tablets & 10 mg tablets
11990220|NCT00661882|Other|medical chart review|"Medical information, called protected health information (PHI), which includes demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history will be accessed from the subject's medical record."
11990255|NCT00661635|Drug|valdecoxib|valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
11990256|NCT00661635|Drug|valdecoxib|valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
11990221|NCT00661882|Other|questionnaire administration|Provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, age of death) will be recorded. This information will be collected by whichever method they prefer; completing the questionnaires on hardcopy (to then be entered into the PCCR by a data manager) or by logging on to the PCCR website to complete the questionnaires by obtaining a user id and password to enter their information directly into the PCCR. Study participants who are in the EDRN project are required to complete the questionnaires on hardcopy (to then be entered into the PCCR by a data manager).
11990222|NCT00661882|Other|study of socioeconomic and demographic variables|Share the information they provided with the PCCR research collaborators. This national group has formed the PCCR and is dedicated to pooling their efforts against pancreatic cancer.
11990223|NCT00661882|Procedure|biopsy|Release a portion of pancreatic tissue, tumor tissue and/or metastatic pancreatic cancer tissue and/or paraffin embedded tissue that has already been collected and saved from their previous surgery or biopsy for storage in the UNMC Solid Tumor Bank for future studies done here or at collaborating institutions. All studies will be proposed in future IRB submissions.
11990224|NCT00661869|Other|Wellness Program|36 weeks of educational and supportive interventions
11990225|NCT00661856|Dietary Supplement|Soy protein|25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months
11990226|NCT00661843|Other|Integrated Yoga style practice|Intervention constitutes of 2 supervised yoga style classes per week incorporating gentle postures,relaxation and meditation sequences. In addition daily home based sessions of yogic relaxation, and meditation a an audio CD
11990227|NCT00661830|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
11990228|NCT00661830|Drug|Placebo|Placebo
11990229|NCT00661830|Drug|Sorafenib|Sorafenib 400 mg bid orally continuously
11990230|NCT00661817|Behavioral|Lifestyle Modification Program|"Participants will receive a behavior change prescription and skills training, offered via the Internet or through a combination of tailored print materials and an interactive voice response system, together with support strategies to enhance the intensity of the interpersonal and social-environmental support."
11990231|NCT00661817|Behavioral|Usual Care and Reading Materials|"Participants in this group will receive usual medical care provided by their own primary care providers. They will also receive the NHLBI's Aim for a Healthy Weight brochure at the baseline study visit and again at the beginning of Year 2."
11990232|NCT00661791|Behavioral|Massage therapy without exercise|Infants will receive massage twice a day; 15 minutes each.
11990233|NCT00661791|Behavioral|Massage therapy with exercise|Infants will receive massage with exercise twice a day; 15 minutes each.
11990234|NCT00661778|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid in glass vials.
11990235|NCT00661778|Drug|Cisplatin|Bevacizumab was supplied as a sterile liquid in glass vials.
11990236|NCT00661778|Drug|Docetaxel|Bevacizumab was supplied as a sterile liquid in glass vials.
11990237|NCT00661765|Drug|varenicline tartrate|Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
11990238|NCT00661765|Drug|varenicline free base|A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
11990239|NCT00661752|Device|quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac|Comparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR
11990240|NCT00661752|Device|quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac|Comparison of the diagnostic quality of 6 SPS quarter-time rest acquisitions with FBP and half-time WBR rest studies; simulated 8 SPS and 10 SPS quarter-time rest acquisitions are also compared to FBP and half-time WBR rest studies.
11990241|NCT00661739|Drug|Bendamustine|Dose-level Bendamustine(mg/m²): I:50; II:60; III:60; IV:70; V:70 Dose-level Paclitaxel (mg/m²): I:60; II:60; III:80; IV:80; V:90 Treatment will be given on day 1,8,15 and repeated on day 29. When the recommended dose has been determined a total of 48 pts will be treated at this dose level.
11990242|NCT00661726|Drug|Decitabine (USAN, INN)|Participants will receive 0.2 mg/kg of decitabine subcutaneously twice a week for 12 weeks. The dose will be reduced for toxicities as needed. The maximum dose of decitabine to be given will be 0.2 mg/kg.
11990243|NCT00661713|Biological|rMenB+OMV NZ|
11990244|NCT00661713|Biological|Placebo|
11990245|NCT00661700|Drug|Levitra (Vardenafil, BAY38-9456)|10mg Vardenafil for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg Vardenafil or down to 5mg Vardenafil followed by 14 weeks treatment at preferred dose.
11990246|NCT00661700|Drug|Placebo|10mg placebo for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg placebo or down to 5mg placebo followed by 14 weeks placebo at preferred dose
11990247|NCT00661687|Device|Currently Marketed PureVision Contact Lens.|Contact lens for continuous wear
11990248|NCT00661687|Device|Alternate Design of the PureVision Contact Lens.|Contact lens for continuous wear
11990249|NCT00661674|Drug|Palonosetron|"Over 3 study visits, patients will receive one of the following treatment regimens:
~Placebo saline IV and sugar pill
~0.75 mg Palonosetron IV and sugar pill
~0.75 mg Palonosetron IV and 100 mg hydroxyzine PO"
11990250|NCT00661674|Drug|Hydroxyzine|"Over 3 study visits, patients will receive one of the following treatment regimens:
~Placebo saline IV and sugar pill
~0.75 mg Palonosetron IV and sugar pill
~0.75 mg Palonosetron IV and 100 mg hydroxyzine PO"
11990251|NCT00661674|Other|Placebo|"Over 3 study visits, patients will receive one of the following treatment regimens:
~Placebo saline IV and sugar pill
~0.75 mg Palonosetron IV and sugar pill
~0.75 mg Palonosetron IV and 100 mg hydroxyzine PO"
11990252|NCT00661661|Drug|CP-690,550|5 mg BID up to 10 mg BID until launch
11990253|NCT00661648|Device|the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)|artificial pancreas
11990254|NCT00661635|Drug|placebo|valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5
11990556|NCT00659438|Drug|Placebo|orally, once daily
11990257|NCT00661622|Drug|GM-CSF|2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
11990258|NCT00661622|Procedure|Embolization|A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
11990259|NCT00661609|Drug|AZD4877|Intravenous (IV)25mg/weekly
11990260|NCT00661596|Drug|Levitra (Vardenafil, BAY38-9456)|5 mg, 10 mg and 20 mg one hour prior to sexual intercourse
11990261|NCT00661596|Drug|Placebo|Matching placebo
11990262|NCT00661583|Drug|Ranibizumab|0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
11990263|NCT00661583|Drug|Ranibizumab and MMC|Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
11990264|NCT00661583|Drug|MMC|MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
11990265|NCT00661570|Device|Provox Vega voice prosthesis (20 Fr)|The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system
11990266|NCT00661557|Biological|Meningococcal vaccine GSK134612 (Nimenrix)|one dose, as intramuscular injection
11990267|NCT00661544|Drug|Arsenic Trioxide|Dose Level 1: None; Dose Level 2: 0.15 mg/kg days Intravenous (IV) Days -9 to -3; Dose Level 3: 0.25 mg/kg days IV Days -9 to -3.
11990268|NCT00661544|Drug|Melphalan|Dose Levels 1, 2, & 3: 100 mg/m2 IV Days -4, -3.
11990269|NCT00661544|Drug|Ascorbic Acid|Dose Levels 1, 2, & 3: 1000 mg IV Days -9 to -3.
11990270|NCT00661531|Drug|Estrace|Estrace 10 mg three times daily will be administered for 3 months.
11990271|NCT00661531|Drug|Anastrozole|After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
11990272|NCT00661505|Drug|methoxy polyethylene glycol-epoetin beta|120, 200 or 360 micrograms iv every 4 weeks (starting dose)
11990273|NCT00661492|Drug|cetuximab|Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter
11990274|NCT00661492|Drug|Mitoxantrone|Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all patients who enter study on LHRH agonists
11990275|NCT00661479|Drug|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1.
11990276|NCT00661479|Drug|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1.
11990277|NCT00661479|Drug|100 µg Brimonidine Tartrate Implant|100 µg brimonidine tartrate implant in the study eye on Day 1.
11990278|NCT00661479|Other|Sham (no implant)|Sham in the fellow eye on Day 1.
11990279|NCT00661466|Drug|Bupivacaine Collagen Sponge|
11990280|NCT00661466|Drug|Placebo|placebo
11990281|NCT00661453|Drug|Valproic Acid and Levocarnitine|Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight
11990282|NCT00661440|Drug|Neramexane mesylate|2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day
11990283|NCT00661427|Biological|cetuximab|Cetuximab 500 mg/m^2 IV over 2 hours every other week
11990284|NCT00661427|Biological|cetuximab|Cetuximab 750 mg/m^2 IV over 3 hours every other week
11990285|NCT00661414|Biological|ASONEP (sonepcizumab/LT1009)|"ASONEP [sonepcizumab/LT1009] is supplied as a colorless,particulate-free, pH 6.5, sterile solution containing approximately 10 mg/mL or 20 mg/mL of drug.
~The candidate drug is intended for single intravenous (iv) use administered over 90 minutes on a weekly basis."
11990286|NCT00661401|Biological|gammaglobulin|They were administered a polyvalent, pasteurized liquid immune globulin subcutaneously (human 16% Beriglobin ®, Germany) with doses ranging from 57 to 132 mg/kg/week in order to maintain the same dosage they received by intravenous route monthly previous to this protocol. After a wash-out period (15 weeks) of the subcutaneous immunoglobulin administration, blood was collected every 4 weeks immediately before infusions. The infusions were administered using battery-powered ambulatory syringe drivers together with 10 or 20 ml syringe and infusions sets according to a pre-defined protocol (Gardulf et al, 2006).
11990287|NCT00661388|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|sc every month (starting dose 1.2 micrograms/kg)
11990288|NCT00661375|Drug|Nexavar (Sorafenib, BAY43-9006)|BAY 43-9006 400mg b.i.d. Treatment will continue until progression of underlying disease, unacceptable toxicity whose causal relationship to the study drug cannot be ruled out and which requires discontinuation of the drug, or consent withdrawal.
11990289|NCT00661362|Drug|Saxagliptin|Oral tablet, once daily for 24 weeks
11990290|NCT00661362|Drug|Placebo|oral tablet, once daily for 24 weeks
11990291|NCT00661362|Drug|Metformin|oral tablet, once daily for 24 weeks
11990292|NCT00661349|Drug|Lopinavir/ritonavir|2 ITIAN (o 1 ITIAN+TDF)+ lopinavir/ritonavir, 2 tablet 200/50 mg to 12 hours
11990293|NCT00661349|Drug|Nevirapine|2 ITIAN (o 1 ITIAN+TDF)+ nevirapine, 2 tablet 200/50 mg to 12 hours
11990294|NCT00661336|Drug|buthionine sulfoximine|
11990295|NCT00661336|Drug|melphalan|
11990296|NCT00661336|Genetic|microarray analysis|
11990297|NCT00661336|Other|high performance liquid chromatography|
11990298|NCT00661336|Other|laboratory biomarker analysis|
11990299|NCT00661336|Other|pharmacological study|
11990300|NCT00661336|Procedure|biopsy|
11990301|NCT00661310|Other|Drug review 80+ -To reduce usage of hospital care|drug review performed by multiprofessional team, including clinical pharmacist, in order to optimize drug therapy and reduce usage of hospital care. Also patient education and follow-up
11990302|NCT00661297|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg Vardenafil to be taken 1 h prior to sexual attempt
11990303|NCT00661297|Drug|Placebo|Matching placebo
11990304|NCT00661271|Behavioral|Mindfulness-based stress reduction (MBSR)|8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.
11990305|NCT00661271|Behavioral|Healthy topics|8 week health education program with one retreat session
11991981|NCT00649714|Drug|Zonegran® Capsules 100 mg|100mg, single dose fed
11990306|NCT00661258|Behavioral|Electronic drug monitoring feedback data|All patients were given electronic drug monitors that can monitor pill-taking behavior. In the intervention arm, patients and their attending doctors were given the electronic drug monitoring data on pill bottle openings at each monthly visit for use in adherence counseling sessions. Control arm patients were not given their electronic drug monitoring feedback data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.
11990307|NCT00661245|Device|TOGA|Transoral Gastroplasty (TOGA®) System for gastric stapling.
11990308|NCT00661245|Device|Control|The control device (bougie dilator) is a FDA-cleared (Class II) device.
11990309|NCT00661219|Drug|Levitra (Vardenafil, BAY38-9456)|BAY 38-9456 (vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
11990310|NCT00661219|Drug|Placebo|Identical placebo will be matched for each vardenafil dosage form and will be indistinguishable from active treatment.
11990311|NCT00661206|Drug|Clopidogrel|Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day
11990312|NCT00661206|Drug|Placebo|Patients randomized in this group will receive placebo for 6 months.
11990313|NCT00661193|Drug|carboplatin|given IV
11990314|NCT00661193|Drug|erlotinib hydrochloride|given orally
11990315|NCT00661193|Drug|paclitaxel|given IV
11990316|NCT00661180|Drug|Nexavar (Sorafenib, BAY43-9006)|Patients will receive Bay 43-9006 400 mg po twice daily in a continuous, uninterrupted schedule. Treatment will continue until there is objective evidence of disease progression, or until evidence of toxicities that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.
11990317|NCT00661167|Drug|ABI-007|ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
11990318|NCT00661154|Drug|Bevacizumab|2-12microCi IV injection
11990319|NCT00661141|Drug|Antizol|
11990320|NCT00661141|Drug|Placebo|
11990321|NCT00661141|Other|Ethanol|oral dose of ethanol (0.5 g/kg)
11990322|NCT00661115|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
11990323|NCT00661115|Drug|Placebo|Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
11990324|NCT00661102|Drug|Corticosteroids|As prescribed
11990325|NCT00661102|Drug|Placebo|As prescribed
11990326|NCT00661102|Drug|capecitabine [Xeloda]|As prescribed
11990327|NCT00661102|Drug|dexpantenol [Bepantol]|As prescribed
11990328|NCT00661089|Drug|Botulinum Toxin Type A - OnabotulinumtoxinA|100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.
11990329|NCT00661089|Drug|Placebo (Saline)|Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.
11990330|NCT00661076|Drug|adefovir dipivoxil|10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
11990331|NCT00661076|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms weekly for 48 weeks
11990332|NCT00661063|Drug|ketamine|ketamine 150 mcg/g bid
11990333|NCT00661063|Drug|vehicle gel|bid - 12 weeks
11990334|NCT00661063|Drug|ketamine + clonidine|ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
11990335|NCT00661063|Drug|clonidine gel 1%|bid 12 weeks
11990336|NCT00661050|Procedure|Alternative Medicine|
11990337|NCT00661050|Procedure|Tai Chi instruction and class participation or walking exercise and sitting meditation|
11990338|NCT00661037|Device|Implantable defibrillator|Implantable defibrillator to reduce ventricular arrhythmias via shock.
11990339|NCT00661037|Device|Implantable defibrillator|Implantable defibrillator to reduce ventricular arrhythmias via shock.
11990340|NCT00661024|Procedure|intraoperative RLN visualization|intraoperative RLN visualization
11990341|NCT00661024|Procedure|intraoperative neuromonitoring of the RLN|IONM
11990342|NCT00661011|Procedure|Lobectomy followed by concomitant mediastinal chemoradiotherapy|Lobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29
11990343|NCT00660998|Drug|Levitra (Vardenafil, BAY38-9456)|5mg, 10mg or 20mg taken 1h before sexual intercourse
11990344|NCT00660998|Drug|Placebo|Matching placebo
11990345|NCT00660985|Drug|Adapalene|Gel, 0.3%, 2g, once daily for 30 days
11990346|NCT00660985|Drug|Adapalene|Gel, 0.1%, 2g, once daily for 30 days
11990347|NCT00660972|Drug|Raltegravir|400 mg tablet taken orally twice daily
11990348|NCT00660972|Drug|Emtricitabine/tenofovir disoproxil fumarate|Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily. FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.
11990349|NCT00660959|Drug|lixivaptan|oral capsule
11990350|NCT00660959|Drug|placebo|oral capsule
11990351|NCT00660933|Drug|Iron sucrose|Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
11990352|NCT00660933|Drug|NaCl|NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days
11990353|NCT00660920|Drug|Ponatinib|Comparison of different dosages of drug given orally once per day.
11990354|NCT00660907|Drug|dapagliflozin|Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
11990355|NCT00660907|Drug|glipizide|Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
11990356|NCT00660907|Drug|metformin hydrochloride|Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
11990357|NCT00660894|Drug|folinate calcium|
11990358|NCT00660894|Drug|tegafur-uracil|
11990359|NCT00660894|Drug|tegafur-gimeracil-oteracil potassium|
11990360|NCT00660881|Biological|Epratuzumab|Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.
11990361|NCT00660868|Drug|Pentoxifylline retard 400mg|Agapurin retard 400mg 3/day per os for 3 weeks
11990362|NCT00660855|Drug|parecoxib/valdecoxib|parecoxib 40 mg intravenously after recovery from anesthesia; if pain persisted, the patient could receive an optional second drug dose on Study Day 1 (only) if more than 4 hours after the first dose. When the patient was able to tolerate oral medication, one valdecoxib 40 mg tablet was administered by mouth once daily in the morning until a maximum period of 7 days.
11990363|NCT00660842|Procedure|carboplatin|AUC 6 IV day 1 every 21 days
11990364|NCT00660842|Drug|paclitaxel|175 mg/m2 IV day 1 every 21 days
11990365|NCT00660842|Drug|carboplatin|AUC 2 IV every week
11990366|NCT00660842|Drug|paclitaxel|60mg/m2 IV every week
11990367|NCT00660829|Drug|Placebo|Placebo
11990368|NCT00660829|Drug|0.15% Azelastine Hydrochloride|0.15% Azelastine Hydrochloride 822 mcg
11990369|NCT00660816|Drug|erlotinib hydrochloride|Given orally once daily on days 2-19.
11990370|NCT00660816|Drug|pemetrexed disodium|Given IV over 10 minutes on day 1
11990371|NCT00660816|Drug|docetaxel|IV over 60 minutes on day 1.
11990372|NCT00660803|Drug|Fulvestrant|
11990373|NCT00660790|Other|Intensified Treatment of risk factors|Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
11990374|NCT00660777|Behavioral|Deep breathing, bilateral alternate chewing, nasal lavage|Deep breathing, bilateral alternate chewing, nasal lavage
11990375|NCT00660777|Behavioral|Oropharyngeal exercises|Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
11990376|NCT00660764|Drug|Rosuvastatin|Oral
11990377|NCT00660751|Drug|Duloxetine|SNRIs
11990378|NCT00660725|Drug|Vandetanib|Vandetanib is a pill that will be self-administered orally on Days 1-14 of each 14-day cycle. The dose of vandetanib each subject will receive will be determined by a dose escalation schedule (either 200 mg or 300 mg per day), which will be followed to determine the MTD of the study drug combination (vandetanib + GemOx). In the absence of disease progression, unacceptable toxicities, or other complications, the vandetanib and GemOx combination may continue per protocol for a maximum of 6 cycles, or 12 weeks. In subjects who show response or stable disease, vandetanib may be continued as a single agent beyond the 6 cycle maximum, at the investigator's discretion.
11990379|NCT00660725|Drug|Gemcitabine|30-minute IV infusion of 1000 mg/m^2 gemcitabine on Day 1 of each 14-day cycle.
11990380|NCT00660725|Drug|Oxaliplatin|Immediately following gemcitabine IV: 2-hour IV infusion of 85 mg/m^2 oxaliplatin on Day 1 of each 14-day cycle.
11990381|NCT00660699|Drug|Gemcitabine|
11990382|NCT00660699|Drug|Docetaxel|
11990383|NCT00660699|Radiation|Radiation|
11990384|NCT00660686|Behavioral|Resistance Exercise|60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
11990385|NCT00660686|Behavioral|Flexibility Training|60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
11990386|NCT00660673|Drug|Levodopa-carbidopa intestinal gel|should be kept within a range of 0.5-10 ml/hour (10-200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour);
11990387|NCT00660673|Device|CADD-Legacy® 1400 ambulatory infusion pump|pump
11990388|NCT00660660|Drug|Esomeprazole|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
11990389|NCT00660660|Drug|Placebo|once daily
11990390|NCT00660647|Drug|Adalimumab|Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
11990391|NCT00660647|Drug|Placebo|Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years
11990392|NCT00660634|Procedure|Endovascular Revascularization|Angioplasty/Stenting of femoro-popliteal lesions
11990393|NCT00660621|Drug|Temozolomide and Bevacizumab|"Between 14 and 28 days after surgery, all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin with concomitant temozolomide at a daily dose of 75 mg/m2 (7 days/week).
~No later than 45 days after date of completion of radiation therapy, all subjects will begin dose dense temozolomide at dose of 150 mg/m2 on Days 1-7 and 15-21 of a 28 day cycle with concomitant bevacizumab 10mg/kg administered intravenously every other week."
11990394|NCT00660595|Drug|Quetiapine|Oral administration
11990395|NCT00660595|Drug|Risperidone|Oral administration
11990396|NCT00660582|Drug|Cetuximab (Erbitux)|500 mg/m² every second week, intravenous infusion, 8 cycles
11990397|NCT00660582|Drug|Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid|Given in combination day 1 and 2, every second week, 8 cycles
11990398|NCT00660556|Device|Archimedes Constant Flow Pump & System|Pump implanted in abdomen with intrathecal delivery (catheter) for pain.
11990399|NCT00660543|Drug|Gadolinium|Given IV
11990400|NCT00660543|Drug|Ferumoxytol Non-Stoichiometric Magnetite|Given IV
11990401|NCT00660543|Other|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE MRI
11990402|NCT00660543|Other|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo DSC MRI
11990403|NCT00660543|Other|Diffusion Weighted Imaging|Undergo DWI
11990404|NCT00660543|Other|MRI-Based Angiogram|Undergo TOF MR angiography
11990405|NCT00660530|Drug|Lanthanum Carbonate Chewable Product|Lanthanum carbonate 1 g to be chewed, three times daily with meals
11990406|NCT00660530|Drug|Lanthanum carbonate crushed powder|Lanthanum carbonate (Fosrenol) 1 g crushed into a fine powder, three times daily with meal
11990407|NCT00660517|Drug|MP29-02|azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day
11990408|NCT00660517|Drug|azelastine Hcl|azelastine Hcl nasal spray one spray per nostril two times a day
11990409|NCT00660517|Drug|fluticasone propionate|fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day
11990410|NCT00660517|Drug|placebo|placebo nasal spray one spray per nostril two times a day
11990411|NCT00660504|Drug|Amrubicin Hydrochloride|Amrubicin Hydrochloride combined with cisplatin
11990412|NCT00660504|Drug|Etoposide-Cisplatin combined chemotherapy|combined chemotherapy
11990413|NCT00660491|Other|exercise training|moderate intensity exercise group, and high intensity exercise group
11990414|NCT00660478|Device|Endeavor|Comparison of two different drug eluting coronary stents
11990415|NCT00660478|Device|Cypher Select|Comparison of two different drug eluting coronary stents
11990416|NCT00660452|Drug|Staloral|Sublingual immunotherapy with Staloral dust mites solution
11990417|NCT00660439|Behavioral|Narrative Exposure Therapy|"Psychological treatment, with narration of positive and traumatic events in patients history, including in vivo exposure of traumatic events. The narrative is written down by the therapist."
11990418|NCT00660426|Drug|Oxaliplatin|
11990419|NCT00660426|Drug|Gemcitabine|
11990420|NCT00660426|Drug|Capecitabine|
11990421|NCT00660413|Device|TOF-Watch SX (Acceleromyography)|Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.
11990422|NCT00660400|Drug|5-azacitidine|Once enrolled, the patients will receive pre-transplant 5-azacitidine (Vidaza) 75 mg/M^2/day subcutaneously for 5-7 days every 28 days). Adjustments in dose and timing may occur based on clinical and hematological parameters.
11990423|NCT00660400|Procedure|Allogeneic Hematopoietic Cell Transplantation (HCT)|"Patients will receive transplantation if there is either a suitable sibling or an unrelated donor.
~Response will be evaluated by bone marrow biopsy after 4 cycles of 5-azacitidine or prior to HCT whichever comes first. Due to the very high risk of progression to AML or death in this patient population, the HCT will be done as soon as possible.
~The patients may have additional cycles of 5-azacitidine per standard hematology practice until scheduled for transplant or until progression of disease.
~All patients will be followed until time to progression of MDS, AML or death or a maximum of 1 year. For patients that are transplanted, follow up will be to one year post-transplant."
11990424|NCT00660387|Drug|Levodopa carbidopa intestinal gel (LCIG)|infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour)
11990425|NCT00660387|Drug|Placebo Gel|
11990426|NCT00660387|Drug|Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets|
11990427|NCT00660387|Drug|Placebo (PBO) oral capsules|
11990428|NCT00660387|Device|CADD-Legacy® 1400 ambulatory infusion pump|
11990429|NCT00660387|Device|PEG tube|percutaneous endoscopic gastrostomy tube
11990430|NCT00660387|Device|J-tube|jejunal tube
11990431|NCT00660374|Drug|insulin NPH|"Soft-treat-to-target dose titration scheme, injection s.c."
11990432|NCT00660374|Drug|EX1000|"Soft-treat-to-target dose titration scheme, injection s.c."
11990433|NCT00660348|Drug|morphine sulfate|This is morphine given in the traditional methods.
11990434|NCT00660348|Device|Medtronic intrathecal pump|This pump will be inserted into the research subject and then the pump will deliver morphine.
11990435|NCT00660335|Drug|RG1068 (synthetic human secretin)|Single-dose, IV infusion
11990436|NCT00660322|Behavioral|Telephone Asthma Program|"The parent will have access to a trained asthma coach for 12 months. The coach will call the parents at mutually convenient times (up to 12 times a year) to work on 4 targeted asthma behaviors:
~Using asthma controller medications as prescribed
~Having and Asthma Action Plan available to all who may need it.
~Using asthma rescue medications with the child's first symptoms.
~Having a collaborative relationship with the child's primary care provider that includes asthma check-ups at least twice a year."
11990437|NCT00660309|Drug|Aliskiren|Aliskiren 300 mg tablets
11990438|NCT00660309|Drug|Irbesartan|Irbesartan 300 mg tablets
11990439|NCT00660309|Drug|Captopril|Captopril 25 mg tablet
11990440|NCT00660296|Other|Air insufflation use in colonoscopy|Air insufflation for colonic distension
11990441|NCT00660296|Other|CO2 use in colonoscopy|Co2 insufflation for colonic distension
11990442|NCT00660283|Drug|Temozolomide|"(Stage I Treatment) Postoperative concomitant limited-field radiation therapy with daily temozolomide (75 mg/m2) must begin between 14 and 28 days from surgery.
~7. (Stage II Treatment) temozolomide 150 mg/m2 to be given days 1-7 and 15-21 of a 28 day cycle to begin within 45 days of stop date of concomitant limited field radiation/daily temozolomide (Stage I treatment) up to a maximum of 12 cycles."
11990443|NCT00660270|Procedure|Pancreatic Surgery|
11990444|NCT00660270|Radiation|Radiation therapy|
11990445|NCT00660270|Drug|Cisplatin|
11990446|NCT00660270|Drug|5-FU|
11990447|NCT00660270|Drug|Alpha-interferon|
11990448|NCT00660270|Drug|Gemcitabine|
11990449|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
11990450|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
11990451|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
11990452|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
11990453|NCT00660244|Drug|anastrozole|Oral
11990454|NCT00660231|Drug|bexarotene|Bexarotene daily p.o. 150mg/sq m during week 1 and 2, then 300mg/sq m if tolerated.
11990455|NCT00660231|Drug|gemcitabine hydrochloride|Gemcitabine i.v. 1000mg/sq m day 1 and day 8 of four 21 day cycles.
11990456|NCT00660218|Drug|paclitaxel poliglumex|Phase I: 40 mg/m2 IV weekly in Cohort 1 (first 3 subjects), escalating in increments of 10 mg/m2 for Cohorts 2 through 5 (3 subjects each) until the maximum tolerated dose (up to 80 mg/m2 IV weekly) is established; Phase II: MTD mg/m2 IV weekly as established in Phase I (24 additional subjects)
11990457|NCT00660218|Biological|cetuximab|400 mg/m2 IV loading dose one week prior to starting other study treatments, then 250 mg/m2 IV weekly on same day as paclitaxel poliglumex
11990458|NCT00660218|Radiation|radiation therapy (IMRT or 3D-CRT)|radiation therapy to the head and neck, consisting of 33 daily fractions of 2.12 Gy for a total of 69.96 Gy, to begin the same day as paclitaxel poliglumex
11990751|NCT00658086|Drug|ALN-RSV01|administered by nebulization once daily for 3 days
11990459|NCT00660192|Drug|Botox|subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size.
11990460|NCT00660192|Other|Placebo|subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.
11990461|NCT00660179|Drug|macitentan (ACT-064992)|Tablet, 3 mg dosage, once daily
11990462|NCT00660179|Drug|macitentan (ACT-064992)|Tablet, 10 mg dosage, once daily
11990463|NCT00660179|Drug|placebo|Matching placebo, once daily
11990464|NCT00660166|Biological|NK-Cell Infusion|The infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight.
11990465|NCT00660153|Drug|Tivozanib (AV-951) plus FOLFOX6|"Investigational product, dosage and mode of administration (1 cycle = 4 weeks of treatment):
~Tivozanib (AV-951): 0.5 mg, 1.0 mg, and 1.5 mg oral once daily On Day -5 (± 2 days) subjects will receive a single dose of tivozanib (AV-951) for pharmacokinetic sampling. Beginning on Day 1 of Cycle 1, subjects will receive tivozanib (AV-951) once daily for 3 weeks followed by 1 week off. Tivozanib (AV-951) dosing repeats every cycle in the absence of disease progression or unacceptable toxicity. On days when both tivozanib (AV-951) and the FOLFOX6 chemotherapy regimen are co-administered, tivozanib (AV-951) will be administered immediately prior to the start of the FOLFOX6 chemotherapy regimen.
~Subjects will receive FOLFOX6 chemotherapy every 2 weeks starting on Day 1 of Cycle 1. Subjects will receive 2 treatments of FOLFOX6 in each treatment cycle, starting on Day 1 and Day 15."
11990466|NCT00660140|Drug|Gemcitabine|
11990467|NCT00660140|Drug|Carboplatin|
11990468|NCT00660101|Biological|OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine|OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
11990469|NCT00660088|Other|Ketasyn|10g for 7 days, 20g for 7 or 14 days
11990470|NCT00660075|Drug|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
11990471|NCT00660075|Drug|Placebo|Placebo for 6 weeks
11990472|NCT00660062|Drug|escitalopram|10 mg daily
11990473|NCT00660062|Drug|escitalopram|20 mg daily dosage
11990474|NCT00660062|Drug|escitalopram|30 mg daily dosage
11990475|NCT00660062|Drug|nortriptyline|100 mg daily dosage
11990476|NCT00660049|Device|SNaP Advanced Wound Care System|Application of negative pressure device daily per instructions
11990477|NCT00660049|Other|SNaP|Daily use
11990478|NCT00660049|Other|SNaP|Daily application per protocol
11990479|NCT00660036|Drug|Gemtuzumab ozogamicin|On Day 6 of an inpatient hospital stay: Based on the study design patients will be treated with one of three doses (3 mg/m^2, 6 mg/m^2 or 9 mg/m^2), administered intravenously in 100 ml of 0.9% sodium chloride over 2 hours.
11990480|NCT00660036|Drug|Mitoxantrone|On Days 1-3 of an inpatient hospital stay: 10 mg/m^2 administered via IVPB (intravenous piggy-back) in 50ml normal saline (NS) over 15 minutes
11990481|NCT00660036|Drug|Etoposide|On Days 1-5 of an inpatient hospital stay: 100 mg/m^2 administered intravenously in 500 ml of 0.9% sodium chloride over 2 hours
11990482|NCT00660023|Drug|Methoxy polyethylene glycol-epoetin beta|Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.
11990483|NCT00660010|Drug|Lupron (leuprolide acetate)|Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.
11990484|NCT00659997|Drug|Albendazole|Single oral dose of 400mg
11990485|NCT00659997|Drug|Levamisole|Single oral dose of 2.5mg/kg
11990486|NCT00659984|Drug|UltratraceTM Iobenguane I 131 Imaging|0.1 mCi/kg [3.7 MBq/kg] (minimum dose 1mCi [37MBq] but not to exceed 5 mCi [185 MBq]) of UltratraceTM Iobenguane I 131 given 7 -28 days before therapeutic dose administration on day 0. Thyroid protection will be administered per institutional protocol for I-131-MIBG however, thyroid blocking must be started prior to the Ultratrace imaging dose. Anterior and posterior whole body images will be taken to assess organ distribution, tumor uptake and dosimetry calculations.
11990487|NCT00659984|Drug|UltratraceTM Iobenguane I 131 Therapy|Therapeutic dose will be given on Day 0 if dosimetry scans showed that the prescribed or adjusted dose will not exceed > 23 Gy to the kidneys, > 30 Gy to the liver, or > 15 Gy to the lungs. and tumor uptake confirmed with UltratraceTM imaging dose. Only one treatment course of therapeutic UltratraceTM will be given in this study.
11990488|NCT00659971|Drug|PAC113|PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days
11990489|NCT00659958|Drug|Zonisamide|300 mg tablet. Maintenance dosing period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg.
11990490|NCT00659945|Drug|Aprepitant plus Ondansetron|Aprepitant plus Ondansetron
11990491|NCT00659945|Drug|Ondansetron plus placebo|Ondansetron plus placebo
11990492|NCT00659932|Behavioral|Immediate Cognitive behavioural therapy (CBT)|The Dealing with Anxiety CBT Group Program comprises 7 group sessions: an initial five hour session followed by 6 three hour sessions over a three month period
11990493|NCT00659932|Behavioral|Delayed CBT|Commencement of the CBT Group Program is delayed 3 months
11990494|NCT00659919|Drug|Placebo|
11990495|NCT00659919|Drug|Trazodone|
11990496|NCT00659906|Behavioral|Resistance Exercise|60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
11990497|NCT00659906|Behavioral|Flexibility Training|60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
11990498|NCT00659893|Drug|PEP005 Topical gel|0.05%, two day dose
11990499|NCT00659880|Other|BioCleanse Meniscus|Subjects will undergo routine meniscal allograft transplant surgery.
11990500|NCT00659867|Device|PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes|chromoscopy-guided endomicroscopy with targeted biopsies
11990501|NCT00659867|Device|PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes|Standard endoscopy with random and targeted biopsies
11990502|NCT00659854|Dietary Supplement|Non milk or soy based formula|Babies will be given a non milk or soy base formula for 12 weeks
11990503|NCT00659854|Dietary Supplement|milk based formula|Babies will be given a milk based formula for 12 weeks
11990504|NCT00659841|Drug|Ciclesonide|200µg Ciclesonide versus placebo
11990505|NCT00659841|Drug|Placebo|placebo
11990506|NCT00659828|Drug|Recombinant methionyl human leptin|Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
11990507|NCT00659815|Device|Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.|Daily care for contact lenses.
11990508|NCT00659815|Device|Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.|Daily care for contact lenses
11990509|NCT00659802|Drug|HMPL-004 low dose|HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
11990510|NCT00659802|Drug|Placebo|Matching dose of Placebo
11990511|NCT00659802|Drug|HMPL-004 high dose|HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).
11990512|NCT00659789|Drug|Vacc-4x|Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
11990513|NCT00659789|Drug|Sterile water|Sterile water is used in place of Vacc-4x and in place of Leukine
11990514|NCT00659776|Drug|Ferumoxytol|Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
11990515|NCT00659763|Other|Exclusion diagnosis|"Patient fulfill ROME III criteria No Alarmsignals Blood tests: FBC,CRP, ALAT, bilirubins, bas.phosphatases, Albumine, TSH, calcium, celiac screening, lactase gene test.
~3 consecutive fecal samples for worm, ovaes and parasites Sigmoidoscopy with biopsy"
11990516|NCT00659763|Other|Clinical diagnosis|Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
11990517|NCT00659750|Drug|Ciclesonide|200µg Ciclesonide versus Placebo
11990518|NCT00659750|Drug|Placebo|placebo
11990519|NCT00659737|Drug|Aprepitant|40mg tablet
11990520|NCT00659737|Drug|Scopolamine|1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
11990521|NCT00659711|Drug|Januvia (Sitagliptin) 100 mg|The first group will be started on 100 mg sitagliptin daily for 12 weeks
11990522|NCT00659711|Drug|Placebo|will be placed on a placebo for 12 weeks.
11990523|NCT00659698|Device|the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)|artificial pancreas
11990524|NCT00659685|Drug|Ondansetron|ODT, single-dose, fasting
11990525|NCT00659685|Drug|Zofran ODT|
11990526|NCT00659672|Dietary Supplement|Whey Protein|40 grams per day Whey Protein
11990527|NCT00659672|Dietary Supplement|Soy Protein|40 grams per day soy protein
11990528|NCT00659672|Dietary Supplement|Control (carbohydrate)|40 grams per day maltodextrin
11990529|NCT00659659|Drug|MEDI-563|1.0 mg/kg IV: MEDI-563
11990530|NCT00659659|Drug|MEDI-563|100 mg, 200 mg SC
11990531|NCT00659659|Other|Placebo Comp.|Placebo SC
11990532|NCT00659659|Other|Placebo|Placebo as a single IV infusion (Certain number of subjects)
11990533|NCT00659646|Drug|gentamicin-collagen sponge and levofloxacin|Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.
11990534|NCT00659646|Drug|Levofloxacin only|levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
11990535|NCT00659633|Drug|lidocaine|intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
11990536|NCT00659620|Biological|mesenchymal stem cell|transplantation of mesenchymal stem cell
11990537|NCT00659594|Drug|Ciclesonide|200µg Ciclesonide versus Placebo
11990538|NCT00659594|Drug|Placebo|placebo
11990539|NCT00659581|Drug|Telmisartan|Oral administration
11990540|NCT00659568|Drug|metformin hydrochloride|
11990541|NCT00659568|Drug|temsirolimus|
11990542|NCT00659555|Drug|pazopanib eye drops|Pazopanib will be administered as eye drop solution via topical ocular route. Pazopanib eye drops will be available as white, colorless solution.
11990543|NCT00659555|Drug|Ketoconozole tablets|Ketoconozole will be administered as tablets via oral route. Ketoconozole tablets will be present as white, rounded, scored tablets
11990544|NCT00659542|Procedure|cyanoacrylate glue|1 ml glue
11990545|NCT00659529|Drug|sildenafil|Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.
11990546|NCT00659503|Drug|Ciclesonide|200µg Ciclesonide versus Placebo
11990547|NCT00659503|Drug|Placebo|placebo
11990548|NCT00659490|Drug|AZD1940|800ug oral administration
11990549|NCT00659490|Drug|Naproxen|500mg oral administration
11990550|NCT00659490|Drug|Placebo|Placebo given pre-surgery
11990551|NCT00659477|Drug|insulin glargine|once daily
11990552|NCT00659451|Drug|Losartan|tablets; 50, 100 mg; od; 12 months
11990553|NCT00659451|Drug|Amlodipine|tablets; 5, 10 mg; od; 12 months
11990554|NCT00659438|Drug|ZD6474 (Vandetanib)|300mg orally, once daily
11990555|NCT00659438|Drug|Bicalutamide|150mg orally, once daily
11990557|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990558|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990559|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990560|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990561|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990562|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990563|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990564|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
11990565|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11990566|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
11990567|NCT00659412|Drug|Alefacept|Intramuscular
11990568|NCT00659412|Drug|Methotrexate|Oral
11990569|NCT00659412|Drug|Placebo|Intramuscular
11990570|NCT00659399|Drug|Fondaparinux|Arixtra 2.5 mg by subcutaneous injection once daily for 8 weeks or until disease recurrence or grade 3, 4 adverse events.
11990571|NCT00659386|Drug|Intravenous immunoglobulin therapy|Patients received total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 3 consecutive days.
11990572|NCT00659373|Drug|Tamoxifen|
11990573|NCT00659373|Drug|triptorelin|
11990574|NCT00659373|Drug|Exemestane|
11990575|NCT00659360|Drug|saracatinib|Given orally
11990576|NCT00659347|Drug|DOV 21, 947|Capsules, 25 mg, 2 capsules (1 Active/1 Placebo) BID, 2 weeks Capsules, 25 mg, 2 capsules (2 Active) BID, 2 weeks
11990577|NCT00659347|Drug|Placebo|Capsules,25 mg,BID,6weeks
11990578|NCT00659334|Drug|Ferumoxtran-10 (Combidex)|2.6 mg/kg
11990579|NCT00659334|Procedure|Neurosurgery|neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.
11990580|NCT00659321|Drug|nicotine acid|16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
11990581|NCT00659321|Drug|placebo|16 weeks treatment with placebo
11990582|NCT00659308|Procedure|amniotic membrane transplantation|patients are submitted to amniotic membrane transplantation
11990583|NCT00659308|Procedure|anterior stromal puncture|the other group is submitted to anterior stromal puncture
11990584|NCT00659295|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
11990585|NCT00659282|Drug|biphasic insulin aspart|Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
11990586|NCT00659269|Dietary Supplement|Multivitamin (MV)|Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
11990587|NCT00659269|Dietary Supplement|Multivitamin + Vitamin B12 + Vitamin B6|Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections
11990588|NCT00659269|Drug|Chemotherapy|"Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)
~Ranges of cumulative doses (in mg/m2) are:
~paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800"
11990589|NCT00659243|Drug|rhBSSL|0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment
11990590|NCT00659243|Drug|Placebo|One week treatment
11990591|NCT00659230|Drug|Nepicastat|100-800mg
11990592|NCT00659230|Drug|Placebo|100-800mg placebo
11990593|NCT00659217|Biological|mesenchymal stem cell|Autologous MSC transplantation
11990594|NCT00659204|Drug|nano-silver gel exposed|SilvaSorb® gel applied topically to the hands with a limited exposure time of 10 minutes
11990595|NCT00659204|Drug|alcohol-based hand gel|Purell gel applied topically to the hands with a limited exposure time of 10 minutes
11990596|NCT00659191|Drug|GSK1265744|
11990597|NCT00659178|Drug|SB-485232 (interleukin 18), pegylated liposomal doxorubicin|SB-485232 (interleukin 18), pegylated liposomal doxorubicin
11990598|NCT00659165|Drug|Insulin Detemir|Subjects will be given a dose of detemir equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.
11990752|NCT00658086|Drug|normal saline|administered by nebulization once daily for 3 days
11991252|NCT00654511|Drug|Dexmedetomidine|Dexmedetomidine, 2mcg/kg, Intravenous (IV)
11990599|NCT00659165|Drug|Insulin Glargine|Subjects will be given a dose of glargine equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.
11990600|NCT00659126|Procedure|3 Tesla Magnetic Resonance Imaging|Undergo 3T MRI
11990601|NCT00659126|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE MRI
11990602|NCT00659126|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo DSC MRI
11990603|NCT00659126|Drug|Ferumoxytol|Given IV
11990604|NCT00659126|Drug|Gadolinium|Given IV
11990605|NCT00659126|Procedure|High Field Strength Magnetic Resonance Imaging|Undergo 7T MRI
11990606|NCT00659126|Procedure|Susceptibility Weighted Imaging|Undergo SWI
11990607|NCT00659113|Drug|cisplatin|
11990608|NCT00659113|Drug|tegafur-gimeracil-oteracil potassium|
11990609|NCT00659113|Other|cytology specimen collection procedure|
11990610|NCT00659113|Procedure|endoscopic biopsy|
11990611|NCT00659100|Drug|Gabapentin|Gabapentin 50 mg oral capsule 30 minutes before bedtime
11990612|NCT00659087|Procedure|Femoral Block|Those receiving femoral block postoperatively
11990613|NCT00659087|Other|Usual Care|Those receiving only usual pain management postoperatively
11990614|NCT00659074|Drug|Ondansetron|ODT, single-dose, fasting
11990615|NCT00659074|Drug|Zofran|ODT, single-dose, fasting
11990616|NCT00659061|Dietary Supplement|SPRINKLES|"Sprinkles is a multiple micronutrient fortificant. It is packed as a single serving sachets each containing micro encapsulated iron (12.5 mg), zinc (7.5 mg), vitamin C (30 mg), vitamin A (300 µg), vitamin D (5 µg), folic acid (150 µg) and iodine (90µg).
~Two month supply of the Sprinkle sachet along with advice on its benefits as well as its appropriate use will be given by the LHWs. The LHWs will also provide their age-appropriate nutritional advice as per their regular door to door community services."
11990617|NCT00659061|Behavioral|Nutrition education|Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
11990618|NCT00659048|Drug|Ciclesonide|Ciclesonide 200µg versus Placebo
11990619|NCT00659048|Drug|Placebo|placebo
11990620|NCT00659022|Procedure|immediate surgery (resection of primary colorectal tumor)|no neo-adjuvant treatment, immediate surgery
11990621|NCT00659022|Drug|neo-adjuvant treatment with bevacizumab|neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the colorectal primary
11990622|NCT00659022|Drug|neoadjuvant treatment with capecitabine and oxaliplatin|neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the colorectal primary
11990623|NCT00659022|Drug|neo-adjuvant treatment with bevacizumab, capecitabine and oxaliplatin|neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery of the colorectal primary
11990624|NCT00659009|Other|Reduced barometric pressure|Sleep in reduced barometric pressure environment.
11990625|NCT00659009|Other|Sea level equivalent barometric pressure|Sleep in barometric pressure equivalent to sea level.
11990626|NCT00659009|Other|Reduced barometric pressure|Sleep in reduced barometric pressure environment.
11990627|NCT00658996|Device|SofLens DD Toric|daily disposable wear contact lens for 2 weeks
11990628|NCT00658996|Device|Ciba Vision Focus Dailies Toric Contact Lens|daily disposable wear contact lens for 2 weeks
11990629|NCT00658983|Other|Autologous Platelet Enriched Gel|Treatment with Autologous Platelet Enriched Gel
11990630|NCT00658983|Other|Metalloproteinase Inhibitor|Treatment with Metalloproteinase Inhibitor (Promogran)
11990631|NCT00658970|Drug|KX2-391|2 mg (starting dose)rising dose, oral dosing, twice daily, 21 day cycle(s); until progression or unacceptable toxicity develops
11990632|NCT00658957|Drug|gentamicin-collagen sponge|5 × 5 cm sponge
11990633|NCT00658957|Drug|placebo collagen sponge|5 × 5 cm sponge
11990634|NCT00658931|Drug|Drug treatment with Cymbalta|Drug treatment with Cymbalta
11990635|NCT00658918|Drug|Ciclesonide nasal|safety of Ciclesonide (200µg, 100µg, 25µg)
11990636|NCT00658918|Drug|Placebo|placebo
11990637|NCT00658905|Drug|rhBSSL|0.15 g/L rhBSSL added to infant formula; one week treatment
11990638|NCT00658905|Drug|Placebo|One week treatment
11990639|NCT00658892|Biological|B7-DC cross-linking antibody rHIgM12B7|
11990640|NCT00658892|Other|flow cytometry|
11990641|NCT00658892|Other|immunologic technique|
11990642|NCT00658892|Other|laboratory biomarker analysis|
11990643|NCT00658879|Drug|Somavert (Pegvisomant)|"Somavert (Pegvisomant) 10, 15 or 20mg powder and solvent for solution for injection.
~Dosage, Frequency : According to Japanese LPD.
~Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration."
11990644|NCT00658866|Procedure|Microdialysis|PK measurements with microdialysis
11990645|NCT00658853|Behavioral|4 times 4 minutes high aerobic intensity one leg cycling|3 times per week for 10 weeks
11990646|NCT00658840|Drug|Capecitabine (Xeloda®)|Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).
11990647|NCT00658840|Radiation|Localization, simulation and immobilization|"Radiation dose and planning
~Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm.
~Dose prescription : 90% isodose volume of prescribed dose encompassed PTV
~The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the liver, duodenum, stomach, the kidneys, spinal cord, etc., was calculated."
11990648|NCT00658827|Other|No intervention|This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
11990649|NCT00658814|Drug|Azacitidine|Given IV or SC during induction; given SC during consolidation and maintenance
11990650|NCT00658814|Drug|Gemtuzumab Ozogamicin|Given IV
11990753|NCT00658073|Procedure|Kidney transplantation with MSCs infusion|Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.
11990651|NCT00658801|Radiation|Respiratory gated proton beam radiotherapy|"Prescription dose to PTV as according to the following dose escalation schema:
~Group 1: Tumor size ≤5cm Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week.
~Group 2: 5cm <Tumor size ≤10cm Dose level 1: 54 GyE /18 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week."
11990652|NCT00658788|Drug|clobetasol propionate spray 0.05%|clobetasol propionate spray, 0.05%, applied topically twice daily
11990653|NCT00658788|Drug|calcitriol ointment|calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
11990654|NCT00658775|Drug|Rabeprazole sodium|Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
11990655|NCT00658775|Drug|Esomeprazole|Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
11990656|NCT00658762|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
11990657|NCT00658762|Drug|PD 0332334|Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
11990658|NCT00658762|Drug|paroxetine|Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
11990659|NCT00658762|Drug|Placebo|Capsules, oral, BID, 8 weeks, with 2 week taper
11990660|NCT00658749|Drug|AIR645|AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
11990661|NCT00658749|Drug|Physiologic saline solution|Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
11990662|NCT00658736|Drug|Triamcinolone|Injection of bupivacaine and triamcinolone
11990663|NCT00658736|Drug|Bupivicaine alone|Injection of bupivacaine
11990664|NCT00658723|Drug|Fibrin Pad|Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
11990665|NCT00658723|Device|SURGICEL™|Absorbable hemostat
11990666|NCT00658710|Behavioral|physical therapy sessions|two physical therapy sessions per week for two months
11990667|NCT00658697|Drug|Docetaxel|Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
11990668|NCT00658697|Drug|Bevacizumab|Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
11990669|NCT00658697|Drug|ADT|Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
11990670|NCT00658697|Drug|Bicalutamide|Starting on day 84 orally once daily until hormone therapy is completed
11990671|NCT00658684|Drug|fesoterodine fumarate|4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
11990672|NCT00658671|Drug|ENMD-2076|Capsules, daily dosing in 28 day cycles
11990673|NCT00658658|Biological|Panitumumab|Panitumumab administered by intravenous infusion
11990674|NCT00658645|Drug|Bifeprunox|20 mg daily, encapsulated tablets, orally, 12 months
11990675|NCT00658645|Drug|Placebo|Encapsulated tablets, orally, 12 weeks
11990676|NCT00658645|Drug|Quetiapine|600 mg daily, encapsulated tablets, orally, 12 months
11990677|NCT00658632|Drug|Rabeprazole sodium|Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
11990678|NCT00658632|Drug|Esomeprazole|Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
11990679|NCT00658619|Drug|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
11990680|NCT00658619|Drug|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
11990681|NCT00658619|Other|Sham (no implant)|Sham in one or both eyes on Day 1 and Month 6.
11990682|NCT00658606|Drug|alefacept|IM
11990683|NCT00658606|Procedure|Narrow Band UVB Phototherapy|UVB Phototherapy
11990684|NCT00658593|Drug|capecitabine|
11990685|NCT00658593|Drug|gemcitabine hydrochloride|
11990686|NCT00658593|Procedure|quality-of-life assessment|
11990687|NCT00658580|Drug|Cisplatin + etoposide|"Cisplatin 90 mg/m² day 1, every 3 weeks
~Etoposide 100 mg/m² days 1-3, every 3 weeks"
11990688|NCT00658580|Drug|Epirubicin + ifosfamide + etoposide|"Epirubicin 60 mg/m² day 1, every 3 weeks
~Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks
~Etoposide 100 mg/m² days 1-3, every 3 weeks"
11990689|NCT00658567|Drug|Pimavanserin tartrate (ACP-103)|10 mg, tablet, once daily by mouth, for six weeks
11990690|NCT00658567|Drug|Pimavanserin tartrate (ACP-103)|20 mg, tablet, once daily by mouth, for six weeks
11990691|NCT00658567|Drug|Pimavanserin tartrate (ACP-103)|Placebo, tablet, once daily by mouth, for six weeks
11990692|NCT00658554|Drug|ARQ 197|Treatment with ARQ 197
11990693|NCT00658541|Drug|Zolpidem Tartrate 10 mg tablet|10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
11990694|NCT00658541|Drug|Zolpidem Tartrate 10 mg tablet (Ambien®)|10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
11990695|NCT00658528|Drug|Rabeprazole sodium|Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
11990696|NCT00658528|Drug|Esomeprazole|Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
11990697|NCT00658515|Drug|Dalcetrapib (RO4607381)|600mg po daily
11990698|NCT00658515|Drug|Evidence-based medical care for Acute Coronary Syndrome|As prescribed
11990699|NCT00658515|Drug|Placebo|po daily
11990700|NCT00658489|Behavioral|Education|One group of residents will receive extensive web-based training in the promotion of oral health. The second group of residents will complete a single training module in the prevention of iron deficiency. The third arm consists of parent-child dyads, who will participate in one well-child care visit.
11990701|NCT00658476|Dietary Supplement|Fish Oil|Omega-3 fatty acid supplements.
11990702|NCT00658476|Behavioral|Cognitive Behavior Therapy|Adolescents receive cognitive behavior therapy.
11990703|NCT00658476|Other|Placebo|
11990704|NCT00658463|Drug|Rosuvastatin|rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design
11990705|NCT00658463|Drug|Placebo|Placebo
11990754|NCT00658073|Procedure|kidney transplantation without MSC infusion|kidney transplantation with standard immunosuppressive treatment regime
11990755|NCT00658047|Drug|CH-1504|Comparison of different doses of CH-1504
11992099|NCT00648908|Drug|Fampridine-SR|Tablets, 10 mg, BID
11990706|NCT00658450|Behavioral|Cognitive rehabilitation training|"A computerised cognitive training package where children will be required to complete several cognitive tasks. The aim is to strengthen the different cognitive processes during these tasks which in turn may lead to improve cognitive processes.
~Children will complete these tasks in 16 session for 8 weeks."
11990707|NCT00658437|Drug|CY-503|solution for subcutaneous injection, 350 ng twice weekly
11990708|NCT00658411|Drug|deferoxamine|Given intravenously or subcutaneously over 8-12 hours daily for at least three weeks prior to transplantation date and continue until the day before the participant receives their donor's stem cells.
11990709|NCT00658398|Behavioral|Interactive Computer Program to prevent alcohol misuse.|Interactive Computer Program with questionnaires, video and informations
11990710|NCT00658385|Genetic|GCSF, Central venous line placement, Stem cell Collection (leukapheresis)|"Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.
~These will be done again 24 hours after your stem cells are collected."
11990711|NCT00658372|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
11990712|NCT00658372|Drug|PD 0332334|Capsules, oral, 300 mg BID, 8 weeks with 2 week taper
11990713|NCT00658372|Drug|Paroxetine|Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper
11990714|NCT00658372|Drug|Placebo|Capsules, oral, placebo, BID, 8 weeks with 2 week taper
11990715|NCT00658359|Drug|Cyclosporine|Standard of care
11990716|NCT00658359|Drug|CP-690,550|CP-690,550 tablets dosed BID Months 12-72
11990717|NCT00658359|Drug|CP-690,550|CP-690,550 tablets dosed BID Months 12-72
11990718|NCT00658346|Drug|Treatment initiation for HIV-1 group O infected patients|"The first line regimen is adapted according to the hemoglobin level and the AgHBs status :
~If Hb > 8 g/ml and negative AgHBs : AZT-3TC (DUOVIR) + LPV/RTV (ALUVIA)
~If Hb <= 8 g/ml and negative AgHBs : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
~If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)"
11990719|NCT00658346|Drug|Treatment initiation for HIV-1 group M infected patients|"The first line regimen is adapted according to the hemoglobin level and the AgHBs status :
~If Hb > 8 g/ml and negative AgHBs : AZT-3TC (DUOVIR) + LPV/RTV (ALUVIA)
~If Hb <= 8 g/ml and negative AgHBs : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
~If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)"
11990720|NCT00658333|Drug|Enteric-coated Mycophenolate Acid (EC-MPA)|
11990721|NCT00658333|Drug|Mycophenolate Mofetil (MMF)|
11990722|NCT00658333|Drug|Placebo MMF|
11990723|NCT00658333|Drug|Placebo EC-MPA|
11990724|NCT00658320|Drug|Everolimus|0.75 mg twice daily, trough level adjusting between 3 and 8 ng/ml.
11990725|NCT00658320|Drug|Mycophenolate mofetil (MMF)|The initial dose of 2 gm/day Mycophenolate mofetil was started within 24-36 hours from reperfusion after transplantation. MMF was administered daily for 12 months in the core study and 12 months in the extension study.
11990726|NCT00658320|Drug|Basiliximab|Patients received first dose of basiliximab (20 mg) 2 hours prior to transplantation and 20 mg at Day 4 or according to local practice
11990727|NCT00658320|Drug|Cyclosporine A|The cyclosporine was initiated either pre-transplant or within 24 hours after transplantation following local regime. Standard dose of cyclosporine was administered with MMF. The Reduced dose of cyclosporine was administered with everolimus.
11990728|NCT00658320|Drug|Corticosteroid|Corticosteroid was administered according to local practice during the trial but at a dose not less than 5mg per day for 12 months of the study
11990729|NCT00658307|Device|repetitive transcranial magnetic stimulation (rTMS)|"1 Hz
~The rTMS device is the MagPro X100 Series (produced by Magventure A/S, Farum, Denmark)"
11990730|NCT00658307|Device|repetitive transcranial magnetic stimulation (rTMS)|"20Hz
~The rTMS device is the MagPro X100 Series (produced by Magventure A/S, Farum, Denmark)"
11990731|NCT00658307|Device|sham repetitive transcranial magnetic stimulation (rTMS)|"The rTMS device is the MagPro X100 Series (produced by Magventure A/S, Farum, Denmark)"
11990732|NCT00658294|Other|Stop treatment|
11990733|NCT00658281|Procedure|CBCT Scan|Cone Beam Computed Tomography (CBCT) scan performed once a week.
11990734|NCT00658281|Procedure|OBI KV Imaging|On Board Imager kilovoltage (OBI KV) Imaging performed once a week.
11990735|NCT00658268|Drug|Clodronate|60 mg/ml, 10 ml, single dose mixed in bone graft at operation
11990736|NCT00658268|Drug|Placebo|10 ml, single dose mixed in bone graft at operation
11990737|NCT00658255|Drug|budesonide/formoterol|
11990738|NCT00658255|Drug|formoterol|
11990739|NCT00658229|Behavioral|Strength training group|After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).
11990740|NCT00658203|Device|New Living CHF|PEA CRT optimization
11990741|NCT00658203|Device|New Living CHF|Standard optimized CRT.
11990742|NCT00658177|Drug|Levitra (Vardenafil, BAY38-9456)|20mg to be taken 1 h prior to sexual intercourse
11990743|NCT00658177|Drug|Placebo|Matching placebo
11990744|NCT00658164|Other|Iron depletion treatment|Effect of iron depletion by phlebotomy plus lifestyle changes vs. lifestyle changes alone on liver damage in patients with nonalcoholic fatty liver disease with increased iron stores
11990745|NCT00658138|Device|3M ESPE Adper Scotchbond SE|To be used per manufacturer's instructions.
11990746|NCT00658138|Device|3M ESPE Adper Scotchbond 1XT|To be used per manufacturer's instructions.
11990747|NCT00658125|Procedure|Bilateral fornix DBS implantation,|Fornix DBS for Alzheimer Disease
11990748|NCT00658112|Drug|Benzoyl Peroxide|Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
11990749|NCT00658099|Drug|insulin detemir|Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
11990750|NCT00658099|Drug|insulin NPH|Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
11990756|NCT00658047|Drug|Methotrexate (MTX)|10mg/week for 2 weeks escalated to 15mg/week for 2 weeks escalated to 20mg/week for 8 weeks
11990757|NCT00658034|Procedure|Acupuncture|Subjects will receive acupuncture weekly for six weeks. Subjects will complete a Brief Fatigue Inventory (BFI) questionnaire, a Functional Assessment of Cancer Treatment scale (FACT-G), and a Hospital Anxiety and Depression Scale(HADS) at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why.
11990758|NCT00658034|Procedure|Placebo Acupuncture|"Subjects will receive placebo acupuncture weekly for six weeks. During the placebo phase, placebo acupuncture needles will be applied a few mm away from the required points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. When it is pressed against the skin, the subject feels a slight prick and sees the handle of the needle moving towards the skin as if the needle has been inserted.
~Subjects will complete a BFI, a FACT-G, and a HADS at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why. Subjects in the placebo group will be given the option to receive true acupuncture."
11990759|NCT00658021|Drug|Placebo|Subcutaneous injection, twice a day
11990760|NCT00658021|Drug|Exenatide|Subcutaneous injection, 5 µg, twice a day
11990761|NCT00658021|Drug|Exenatide|Subcutaneous injection,10 µg, twice a day
11990762|NCT00658008|Drug|PD 0332334|Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
11990763|NCT00658008|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
11990764|NCT00658008|Drug|PD 0332334|Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
11990765|NCT00658008|Drug|Paroxetine|Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
11990766|NCT00658008|Drug|Placebo|Capsules, oral, placebo bid, 8 weeks with 2 week taper
11990767|NCT00657995|Device|Artificial Pancreas (STG-22)|safe tool
11990768|NCT00657982|Drug|RAD001|10mg BID
11990769|NCT00657956|Device|Advance Biofoam porous metal backed tibial component with or without screw augmentation|total knee arthroplasty tibial component that has a backing of porous titanium metal to facilitate bone in-growth
11990770|NCT00657943|Drug|metformin|metformin tablets 2 g x 2
11990771|NCT00657943|Drug|insulin detemir|insulin as requested
11990772|NCT00657943|Drug|insulin aspart + insulin aspart protamin|insulin as requested
11990773|NCT00657943|Drug|Insulin aspart|insulin as requested
11990774|NCT00657930|Drug|insulin detemir|observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.
11990775|NCT00657917|Drug|Paromomycin +Gentamicin topical cream|WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
11990776|NCT00657904|Drug|Bicalutamide|150mg daily
11990777|NCT00657904|Drug|Placebo|once daily
11990778|NCT00657891|Drug|Omalizumab|0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously
11990779|NCT00657891|Drug|Placebo|Placebo Injection
11990780|NCT00657878|Drug|stealth liposomal doxorubicin|stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
11990781|NCT00657878|Drug|carboplatin|carboplatin AUC 5 IV day 1 every 21 days
11990782|NCT00657878|Drug|paclitaxel|paclitaxel 175 mg/m2 IV day 1 every 21 days
11990783|NCT00657878|Drug|Topotecan|dosing and schedule according to Institutional guidelines
11990784|NCT00657878|Drug|Gemcitabine|1000 mg/m2 on days 1,8,15 every 28 days
11990785|NCT00657865|Drug|ramipril|oral intake
11990786|NCT00657865|Drug|placebo|placebo
11990787|NCT00657852|Drug|Disodium pamidronate|Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion
11990788|NCT00657852|Drug|Placebo|500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion
11990789|NCT00657839|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg Vardenafil bid
11990790|NCT00657839|Drug|Placebo|Matching placebo
11990791|NCT00657826|Device|ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm|Isolated aortic valve replacement with a size 19mm valve
11990792|NCT00657813|Drug|MNI-330 as a brain SPECT tracer of Beta-Amyloid|Each subject will receive a bolus injection targeted to be 5 miCi and not to exceed 5.5 mCi of MNI-330. Following injection serial dynamic imaging will be obtained over 8 hrs.
11990793|NCT00657800|Behavioral|Intensified inpatient diabetes education program (IDEP)|Assessment of educational needs and coordination of inpatient unit based education program by Certified Diabetes Educator (CDE)
11990794|NCT00657774|Drug|FlutiForm 250/10 ug|SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.
11990795|NCT00657774|Drug|FlutiForm 100/10 ug|SKP FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.
11990796|NCT00657774|Drug|Oral Prednisone 10mg|2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.
11990797|NCT00657774|Drug|Placebo|2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks.
11990798|NCT00657761|Drug|Enfuvirtide|90 mg/12h sc for 7 days
11990799|NCT00657761|Drug|Placebo|0.9% saline solution/12h sc for 7 days
11990800|NCT00657748|Drug|Lithium Gluconate (drug) Glyceryl Triacetate GTA (drug)|Lithium 1.3 mEq/kg/day (three administrations a day)during the study GTA 500 mg/kg/day in four administrations a day during the study
11990801|NCT00657735|Device|H-Coil deep TMS|20 daily deep rTMS treatments
11990802|NCT00657735|Device|sham|inactive treatment
11990803|NCT00657722|Other|Angiography and Computed Tomography|Preoperative angiography and Computed Tomography
11990804|NCT00657709|Biological|Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)|One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
11991067|NCT00655785|Drug|Gemcitabine|Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17
11990805|NCT00657709|Biological|Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)|One dose of rMenB concomitantly with the routinely administered infant vaccines
11990806|NCT00657709|Biological|Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)|One dose of rMenB concomitantly with the routinely administered infant vaccines
11990807|NCT00657709|Biological|Infanrix Hexa|Routine vaccination
11990808|NCT00657709|Biological|Menjugate|One dose of the routinely administered infant vaccines + MenC vaccine
11990809|NCT00657709|Biological|Prevenar|Routine vaccination
11990810|NCT00657683|Biological|Monovalent GBS-CRM glycoconjugate vaccine|1 dose of GBS conjugate vaccine
11990811|NCT00657683|Biological|Placebo|1 dose of placebo
11990812|NCT00657670|Device|Ready-made spectacles|Ready-made spectacles will be dispensed to correct refractive error. Ready-made spectacles are spectacles which are available from an existing inventory. This is different to prescription spectacles which are usually made to order. They have the same spherical power for the right and left eyes and do not include a correction for astigmatism. The limited inventory for this trial includes +1.00 to +4.00 in 0.50 steps, +5.00, +6.00 and +8.00, -1.00 to -6.00 in 0.50 steps, -7.00, -8.00, -9.00 and -10.00. The appropriate spectacles are selected based on the spherical equivalent refractive error. If there is a difference between the two eyes the lower correction is selected.
11990813|NCT00657670|Device|Spectacles|Spectacles will be prescribed to correct refractive error. These spectacles will be custom-prescribed based on the sphero-cylindrical refractive correction. The spectacles used in this arm will be custom made for each participant based on their refraction and can be made in a full range of spherical powers and astigmatic corrections for up to 2.00 dioptres of cylinder.
11990814|NCT00657657|Biological|Engerix™-B|A challenge dose of hepatitis B vaccine will be administered to all subjects as a deep intramuscular injection in the deltoid region of the non-dominant arm.
11990815|NCT00657644|Drug|Levitra (Vardenafil, BAY38-9456)|4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks
11990816|NCT00657631|Behavioral|Acceptance and Commitment Therapy|"Considered part of the third wave of CBT along with Dialectical Behavior Therapy (DBT; Linehan, 1993) and Mindfulness-based Cognitive Therapy (MBCT; Segal, Williams, & Teasdale, 2001), ACT is built upon the strong, research-based foundation of CBT. However, while CBT for psychosis focuses on reducing symptoms, ACT focuses on changing the way in which the person experiences his or her symptoms so that the person can still live his or her life in accordance with his or her life values. Specifically, CBT attempts to reduce delusions by disputing the evidence for the delusion and ACT attempts to increase the person's ability to live his or her life while still experiencing delusions (Hayes, Strosahl & Wilson, 1999)."
11990817|NCT00657618|Drug|Sodium Stibogluconate (SSG)|100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
11990818|NCT00657605|Drug|Recombinant methionyl human leptin|Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
11990819|NCT00657579|Drug|DE-104 ophthalmic solution, low concentration|
11990820|NCT00657579|Drug|DE-104 ophthalmic solution, medium concentration|
11990821|NCT00657579|Drug|DE-104 ophthalmic solution, high concentration|
11990822|NCT00657579|Drug|DE-104 vehicle|
11990823|NCT00657566|Other|duration of antibiotics|4 +/- 1 days of antibiotics
11990824|NCT00657566|Other|duration of antibiotics|active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
11990825|NCT00657553|Drug|Bortezomib|Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks
11990826|NCT00657540|Drug|Analatro|30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses
11990827|NCT00657540|Drug|Saline|50 mL of saline infused over 10 minutes
11990828|NCT00657527|Drug|Rosuvastatin|
11990829|NCT00657527|Behavioral|Cholesterol lowering diet|
11990830|NCT00657514|Drug|Ranolazine|500mg tablet po bid up to 1000mg (2 500mg tablets) po bid
11990831|NCT00657514|Drug|Placebo|1 tablet po bid up to 2 tablets po bid if tolerated
11990832|NCT00657501|Drug|testosterone gel|once daily transdermal gel, 300 mcg
11990833|NCT00657501|Drug|placebo gel|once daily transdermal placebo gel
11990834|NCT00657488|Drug|Thalidomide|Thalidomide 100mg/day or 400 mg/day at bed time during one year
11990835|NCT00657475|Drug|Heparin Low Dose|Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.
11990836|NCT00657475|Drug|Heparin Full Dose|Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.
11990837|NCT00657462|Other|Reminders|Users of the PAML Builder application will receive reminders about three application features (copy/paste, audit trail, sort medications by class) at the startup of the application
11990838|NCT00657449|Drug|valdecoxib|valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8
11990839|NCT00657449|Drug|rofecoxib|rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days
11990840|NCT00657423|Drug|Treated by endostar combined with docetaxel and cisplatin|recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
11990841|NCT00657423|Drug|Treated by docetaxel and cisplatin|docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
11990842|NCT00657410|Drug|dexamethasone|
11990843|NCT00657410|Drug|prednisone|
11990844|NCT00657410|Procedure|quality-of-life assessment|
11990845|NCT00657397|Drug|Methadone|Methadone sirup once daily
11990846|NCT00657384|Drug|acid tranexamic|10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention.
11990847|NCT00657384|Drug|Nacl 0.9%|10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention
11991110|NCT00655499|Biological|panitumumab|
11990848|NCT00657371|Device|Third Eye Retroscope Auxiliary Imaging System|A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.
11990849|NCT00657358|Drug|Lidocaine|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
11990850|NCT00657332|Procedure|blood sample draw|
11990851|NCT00657332|Procedure|urine sample|
11990852|NCT00657319|Drug|biphasic insulin aspart 30|The observation is performed under normal clinical practice conditions without any additionally required diagnostic/therapeutic features. Physicians are allowed to decide the treatment regimen according to the medical standards.
11990853|NCT00657306|Drug|hydrocortisone|50 mg/6 h per day
11990854|NCT00657306|Drug|dextrose solution 5%|dextrose solution 5% 100 ml/6 h per day
11990855|NCT00657293|Behavioral|Arm training program|Patients will undergo a specific arm training program (ATP) three times a week for the duration of the 6 week program. The ATP will consist predominantly of resistance exercises. Muscle groups targeted during the ATP will include deltoid, biceps and triceps, pectoralis and latissimus. Subjects will train using multi station gym equipment and free weights.
11990856|NCT00657293|Behavioral|Purdue pegboard test (sham)|In an attempt to make the groups comparable in terms of attention, the control group will perform the purdue pegboard test of finger dexterity. The tasks will be performed in a sitting position with the arms supported on a table. This test will consist of 4 timed tasks where as many pins as possible will be placed on a pegboard in a given time. Performance of the pegboard test is likely to improve with practice which may serve to motivate the patients to continue practicing over the 6-week period. Subjects will perform this activity 3 times per week with supervision provided by a physiotherapist.
11990857|NCT00657280|Drug|Sitagliptin|No one is blinded to the treatments.
11990858|NCT00657267|Drug|Temozolomide|Taken orally daily for the first three weeks of a four-week cycle.
11990859|NCT00657254|Drug|Nexavar (Sorafenib, BAY43-9006)|Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.
11990860|NCT00657241|Drug|carvedilol|Coreg CR 20 mg (one week) and Coreg CR 40 mg (3 weeks).
11990861|NCT00657241|Drug|valsartan|Valsartan 160 mg (one week); valsartan 320 mg (3 weeks)
11990862|NCT00657228|Drug|Intravenous heparin|"Intravenous heparin as an adjunct for the treatment of anaphylactic/anaphylactoid reactions in the Emergency Department.
~To determine if a single bolus of intravenous unfractionated heparin (in conjunction with standard therapy) given to patients with anaphylactic/anaphylactoid reactions results in a faster time to recovery when compared to standard therapy alone."
11990863|NCT00657228|Drug|Saline|Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.
11990864|NCT00657202|Drug|Ranibizumab|Given as an injection into three cutaneous neurofibromas on day 1 of the study treatment.
11990865|NCT00657189|Drug|MEDI-545|100 mg once; SC Placebo × 12 doses on other weeks
11990866|NCT00657189|Drug|MEDI-545|100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
11990867|NCT00657189|Drug|MEDI-545|100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
11990868|NCT00657189|Drug|MEDI-545|100 mg every week × 13 doses
11990869|NCT00657189|Drug|Placebo|SC Placebo every week × 13 doses
11990870|NCT00657176|Drug|OPB-31121|"100mg tablet
~oral administration, Qd"
11990871|NCT00657163|Drug|fluoxetine|fluoxetine per os 20 mg daily
11990872|NCT00657163|Drug|placebo|placebo per os daily
11990873|NCT00657150|Drug|Enoxaparin|40 mg once daily
11990874|NCT00657150|Drug|Dabigatran etexilate|220 mg once daily
11990875|NCT00657137|Drug|apricoxib + lapatinib + capecitabine|"apricoxib: 100 mg tablets, 400 mg/day
~lapatinib: per package insert
~capecitabine: per package insert"
11990876|NCT00657137|Drug|placebo + lapatinib + capecitabine|"placebo: 100 mg tablets, 400 mg/day
~lapatinib: per package insert
~capecitabine: per package insert"
11990877|NCT00657124|Dietary Supplement|Aminolevan EN|The present study used carbohydrate and BCAA-enriched soft-powder nutrient-mixture for preoperative supplementation. Supplementation with Aminolevan EN (100 g per day) started at two weeks prior to the surgery under the careful monitoring of compliance.
11990878|NCT00657124|Dietary Supplement|Placebo|placebo
11990879|NCT00657111|Drug|CS-8958 formulated as dry powder|CS-8958, formulated as a dry-powder and will be administered from capsules containing 5 mg CS-8958 and lactose to 25 mg (placebo) inserted into a FlowCaps inhaler device.
11990880|NCT00657111|Other|Placebo|placebo capsules containing 25 mg lactose
11990881|NCT00657059|Drug|irbesartan|In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( < 5 g NaCl/day), and then given a stable dose (150mg ~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.
11990882|NCT00657059|Drug|methylprednisolone (MP) or prednisone (pred)|Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment.
11990883|NCT00657059|Drug|mycophenolate mofetil (MMF)|Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month.
11990884|NCT00657046|Drug|Droxidopa|Capsules containing 200 mg droxidopa
11990885|NCT00657046|Drug|Placebo|Capsules with mannitol substituted for droxidopa
11990886|NCT00657033|Drug|Levitra (Vardenafil, BAY38-9456)|BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
11990887|NCT00657033|Drug|Placebo|Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment
11990888|NCT00657020|Drug|Nicotine|Nicotine lozenge containing 4 mg of nicotine
11990889|NCT00657020|Drug|Placebo|Placebo lozenge
11990890|NCT00657007|Biological|belimumab|"1 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 1).
~1 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 5)."
11991111|NCT00655499|Drug|irinotecan hydrochloride|
11991112|NCT00655499|Genetic|chromogenic in situ hybridization|
11990891|NCT00657007|Biological|belimumab|"4 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 2).
~4 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 6)."
11990892|NCT00657007|Biological|belimumab|"10 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 3).
~10 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 7)."
11990893|NCT00657007|Biological|belimumab|"20 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 4).
~20 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 8)."
11990894|NCT00657007|Biological|Placebo|"IV (in the vein) on Day 0 (Cohorts 1-4).
~IV (in the vein) on Days 0 and 21 (Cohorts 5-8)."
11990895|NCT00656994|Drug|Ramelteon|Ramelteon 16 mg, tablets, orally, once nightly for up to 6 months.
11990896|NCT00656994|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once nightly for up to 6 months
11990897|NCT00656981|Drug|YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)|The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
11990898|NCT00656981|Drug|Placebo|The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
11990899|NCT00656968|Drug|10-day sequential treatment|esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10
11990900|NCT00656968|Drug|10-day concomitant therapy|esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10
11990901|NCT00656942|Device|Quantitative Sensory Testing (QST)|QST consists of a series of heat and cold stimulation tests.
11990902|NCT00656929|Dietary Supplement|Vitamin D3|Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months
11990903|NCT00656929|Other|Placebo|Placebo tablets
11990904|NCT00656916|Drug|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
11990905|NCT00656890|Biological|sterile saline for injection|10mg/kg/dose sterile saline injected every other week for a total of 4 doses
11990906|NCT00656890|Biological|MDX-1100|10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
11990907|NCT00656864|Drug|Pioglitazone|Starting dose at 15 mg for two weeks, then titrated up to 45 mg in the subsequent 2 weeks.
11990908|NCT00656864|Drug|Placebo|placebo
11990909|NCT00656851|Drug|Pioglitazone|30mg/day for 16 weeks
11990910|NCT00656851|Behavioral|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
11990911|NCT00656838|Behavioral|Patients receives letter, phone call, office visit, educational materials|Behavioral
11990912|NCT00656825|Drug|P144 cream|P144 cream will be given at a dose of 100 μg/mL
11990913|NCT00656825|Drug|P144 cream|P144 cream will be given at a dose of 200 μg/mL
11990914|NCT00656825|Drug|P144 cream|P144 cream will be given at a dose of 300 μg/mL
11990915|NCT00656825|Drug|Placebo|Placebo will be randomly given to 4 subjects in each panel
11990916|NCT00656812|Drug|Rituximab|375 mg/m2 on day 1 of a 21-day treatment cycle
11990917|NCT00656812|Drug|2-CdA|0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle
11990918|NCT00656799|Drug|sugammadex|At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.
11990919|NCT00656799|Drug|Rocuronium|After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered
11990920|NCT00656786|Drug|Menadione Topical Lotion|Menadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy.
11990921|NCT00656786|Drug|Menadione Topical Lotion|Menadione Lotion will be applied topically twice a day, starting 1 day before EGFRi therapy.
11990922|NCT00656773|Drug|Sufentanil|0.15 μg/kg, IV following by 0.075 μg/kg every 3 minutes during 15 minutes
11990923|NCT00656773|Drug|Morphine|0.15 mg/kg, IV following by 0.075 mg/kg every 3 minutes during 15 minutes
11990924|NCT00656760|Other|PET/CT|PET/CT is being performed on all patients in the study.
11990925|NCT00656747|Drug|Avelox (Moxifloxacin, BAY12-8039)|Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
11990926|NCT00656747|Drug|Amoxicillin clavulanic acid|Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
11990927|NCT00656734|Biological|MDX 1411|MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total
11990928|NCT00656721|Device|Flutter Valve|"Flutter Valve (Scandipharm, Birmingham, AL) is shaped like a pipe with a hardened plastic mouthpiece at one end, a plastic protective, perforated cover at the other end, and a high-density stainless steel ball resting in a plastic circular cone on the inside. When the patient expires, a vibratory effect is transmitted to airways by the steel ball oscillation in order to facilitate mucociliary clearance.
~In our study, the use of the equipment was guided by a registered physical therapist, but the position (angle) was determined by the patient, according to his/her adaptation and perception of effectiveness of sputum clearance. The patients remained comfortably seated, breathing through the device for 15 minutes, starting from the total pulmonary capacity, and being free to cough. Thereafter, a 5-minute session of cough was done."
11990929|NCT00656708|Other|Kerlix AMD gauze|Use Kerlix AMD gauze as the wound dressing for the entire burn unit
11990930|NCT00656695|Drug|Iminoral|Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
11990931|NCT00656695|Drug|Neoral|Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
11990932|NCT00656682|Behavioral|Dietitian Counseling Alone|Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
11990933|NCT00656682|Behavioral|Dietitian Plus Community Group Lifestyle|Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes
11990934|NCT00656669|Drug|sunitinib alone|sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.
11990935|NCT00656669|Drug|sunitinib plus paclitaxel|sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
11990936|NCT00656669|Drug|doxorubicin and cyclophosphamide|doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.
11990937|NCT00656656|Drug|Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine|"Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks
~Rituximab: 1000 mg i.v. given twice at a 2-week interval
~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks
~Azathioprine: 2.5 mg/kg body weight daily p.o."
11990938|NCT00656643|Drug|Sirolimus|Two subconjunctival injections of 440 micrograms sirolimus each.
11990939|NCT00656643|Drug|Placebo|Two subconjunctival injections of placebo.
11990940|NCT00656643|Drug|Sirolimus|Two subconjunctival injections of 220 micrograms sirolimus each.
11990941|NCT00656643|Drug|Sirolimus|Two subconjunctival injections of 880 micrograms sirolimus each.
11990942|NCT00656630|Drug|Acamprosate|Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
11990943|NCT00656630|Drug|Naltrexone|50mg capsule, Once daily, 1 week duration
11990944|NCT00656630|Drug|Placebo|Matched placebo capsule, 1 week duration
11990945|NCT00656617|Drug|Idarubicin|12 mg/m^2 IV over 1 hour daily for 3 days (days 4 to 6)
11990946|NCT00656617|Drug|Cytarabine|1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7)
11990947|NCT00656617|Drug|Vorinostat|Initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
11990948|NCT00656604|Genetic|proteomic profiling|at the time of each procedure.
11990949|NCT00656604|Procedure|lumpectomy or mastectomy|removal of breast tumor or removal of the entire breast in which the tumor is located
11990950|NCT00656604|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Prior to initiation of treatment
11990951|NCT00656604|Procedure|histopathologic examination|After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
11990952|NCT00656604|Procedure|magnetic resonance spectroscopy|Prior to initiation of treatment
11990953|NCT00656591|Drug|Methotrexate|Methotrexate
11990954|NCT00656578|Drug|4975|Single dose, solution
11990955|NCT00656578|Drug|Placebo|Single dose, solution
11990956|NCT00656552|Drug|Escitalopram|Patient undergo a double- blind therapy of Escitalopram (10 mg) orally daily during breakfast (n=50) or placebo (n=50) for four weeks.
11990957|NCT00656539|Drug|AzaSite®|Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
11990958|NCT00656526|Drug|Lidocaine, perineural injection, intraoperatively|0.5 cc lidocaine, one single injection over the dorsal root.
11990959|NCT00656526|Drug|Lidocaine|0.5 cc %2 lidocaine,single injection
11990960|NCT00656513|Drug|Pilocarpine|5mg by mouth 3 times a day for 12 weeks
11990961|NCT00656513|Procedure|ALTENS|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
11990962|NCT00656500|Behavioral|Standard brief advice|Brief general assistance with smoking cessation
11990963|NCT00656500|Behavioral|Quitline intervention|Brief intervention designed specifically to encourage quitline utilization
11990964|NCT00656487|Drug|rimonabant|double blind, placebo controlled, single 90 mg dose
11990965|NCT00656487|Drug|placebo|matched placebo
11990966|NCT00656474|Drug|Placebo gel|Administration of Placebo gel on Day 1, 3 and 5 post ablation.
11990967|NCT00656474|Drug|GLYC-101 gel (1.0 %)|Administration on Day 1, 3 and 5 post laser ablation.
11990968|NCT00656461|Drug|MKC-1|30 mg and 100 mg capsules, dosed BID daily on a continuous schedule
11990969|NCT00656448|Drug|Procrit|40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.
11990970|NCT00656435|Drug|Bevacizumab|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
11990971|NCT00656422|Drug|insulin Levemir|The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
11990972|NCT00656422|Drug|insulin Lantus|The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.
11990973|NCT00656409|Drug|Conjugated pneumococcal vaccine (Prevenar)|
11990974|NCT00656396|Device|Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)|Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time
11990975|NCT00656396|Procedure|Control Intervention|Standard care
11990976|NCT00656383|Other|Clients randomized to nurse-led clinic|Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol
11990977|NCT00656383|Other|Clients receive leg ulcer care in their homes|Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol
11990978|NCT00656370|Drug|recombinant human hyaluronidase|150 Units in 1mL
11990979|NCT00656357|Drug|SYN117 Placebo|Placebo
11990980|NCT00656357|Drug|SYN117 80 mg|SYN117 80 mg
11990981|NCT00656357|Drug|SYN117 160 mg|SYN117 160 mg
11990982|NCT00656357|Drug|Cocaine 10mg|IV Cocaine 10mg
11990983|NCT00656357|Drug|Cocaine 20mg|IV Cocaine 20mg
11990984|NCT00656357|Drug|Cocaine 40mg|IV Cocaine 40mg
11990985|NCT00656357|Drug|Saline|IV Cocaine Placebo
11990986|NCT00656344|Other|Cognitive behavioral treatment enhanced by virtual reality|A cognitive behavioral protocol with cognitive and behavioral techniques will be used to treat symptoms. The exposure part of the treatment will be enhanced with the use of a virtual environment.
11990987|NCT00656331|Drug|Amlodipine and Hydrocholorothiazide|Arm 1 gets Amlodipine and Arm 2 gets Hydrocholorothiazide
11990988|NCT00656318|Other|oral contraceptive pill (OCP; OCPs)|Daily administration of oral contraceptive pill for up to 3 months (2 months of daily administration required for the study).
11990989|NCT00656305|Device|ExAblate MRfFUS|MR guided focused ultrasound.
11990990|NCT00656305|Device|Sham|sham comparator
11990991|NCT00656292|Drug|Simvastatin|40 mg po/nasogastric tube (NG) every day for 6 days
11990992|NCT00656292|Drug|Placebo|1 pill po/NG every day x 6 days
11990993|NCT00656279|Behavioral|Intensive dietary phosphorus education|Intensive dietary phosphorus education will be completed using the Phosphorus Point System Tool, a booklet listing phosphorus points for food items based on the phosphorus content. Patients will be allotted a maximum of 32-40 phosphorus points daily. Points consumed will be tracked by the patients via daily tracking sheets which require patients to list the phosphorus food items consumed, the number of points, and the time and amount of phosphate binders. Patients in this group will also receive intensive education about phosphorus additives. As a part of the program that supports the tool, patients will receive weekly telephone calls for the first 6 weeks to address any questions about the tool and find phosphorus point values of foods not listed within the tool.
11990994|NCT00656266|Drug|mycophenolate mofetil|immunosuppresion medication called mycophenolate mofetil, also known as MMF or CellCept
11990995|NCT00656266|Other|placebo medication|medication that looks like mycophenolate mofetil
11990996|NCT00656253|Drug|Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)|12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
11990997|NCT00656253|Drug|Placebo|12 months period of placebo plus 1 month period without placebo
11990998|NCT00656240|Drug|DE-104 ophthalmic solution|
11990999|NCT00656240|Drug|DE-104 vehicle|
11991000|NCT00656227|Drug|Avotermin|Comparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo
11991001|NCT00656214|Drug|Lycopene|08 mg/day in two divided dosage
11991002|NCT00656214|Drug|Placebo|Two divided dosage
11991003|NCT00656201|Drug|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
11991004|NCT00656201|Drug|Intramuscular Progesterone|Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
11991005|NCT00656188|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse
11991006|NCT00656188|Drug|Placebo|Matching placebo
11991007|NCT00656175|Drug|raltegravir|raltegravir
11991008|NCT00656149|Procedure|Telerehabilitation of hand function|6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.
11991009|NCT00656149|Procedure|Conventional exercise therapy|For one hour per day subjects perform range-of-motion tasks with a wristlet weight (20 min), precision tasks with a computer mouse (20 min) and receive cyclical electrical stimulation of hand muscles (20 min).
11991010|NCT00656136|Drug|placebo|Patients receive placebo once daily
11991011|NCT00656136|Drug|BIBW 2992|Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.
11991012|NCT00656123|Biological|Colon GVAX|Dose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4
11991013|NCT00656123|Drug|cyclophosphamide|200 mg/m^2 administered IV on Day 1 of Cycles 1-4
11991014|NCT00656110|Drug|equal parts of 0.5% plain Marcaine and 2% lidocaine mixed with 0.8 mg Depo-medrol/4% absolute alcohol in a total injection volume of 1 ml|Bilateral 3rd/4th common digital nerve injections with neuroma treatment mixture given weekly for 3 weeks
11991015|NCT00656110|Drug|Normal saline - 1ml|Bilateral 3rd/4th common digital nerve injections with normal saline given weekly for 3 weeks
11991016|NCT00656097|Biological|CL184|CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
11991017|NCT00656097|Biological|HRIG|HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
11991018|NCT00656097|Biological|Placebo matching CL184|Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
11991019|NCT00656084|Drug|gemcitabine|900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.
11991020|NCT00656084|Drug|mitoxantrone|"Novantrone 10 mg/m2on Day 1. The order of administration will be:
~Gemzar-->Novantrone-->Rituxan."
11991021|NCT00656084|Drug|rituximab|"Rituxan 375 mg/m2 on Day 1. The order of administration will be:
~Gemzar-->Novantrone-->Rituxan."
11991022|NCT00656058|Drug|Singulair (Montelukast Sodium)|Singulair (Montelukast Sodium):5-10 mg (weight based dosing) by mouth (PO) hour of sleep (HS)
11991023|NCT00656045|Behavioral|Dietary|All participants in the investigation will receive a standard 8-week behavioral obesity intervention with 8 weekly, 1 hour group counseling and education sessions. The intervention will include a reduced caloric prescription (1200-1500 kcal/day) and fat gram prescription (30% or less kcals from fat).
11991024|NCT00656045|Behavioral|Physical Activity|The Physical Activity arm will receive an activity goal (200 minutes/week of moderate-intense physical activity).
11991025|NCT00656045|Behavioral|TV Watching|The TV Watching arm will receive a TV watching goal of watching less than 10 hours of TV/week.
11991026|NCT00656032|Other|paricalcitol|1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks
11991027|NCT00656032|Other|cinacalcet|0 to 180 mg administered orally every day for either 8 weeks or 16 weeks
11991028|NCT00656019|Drug|Vitamin D|0, 2000, 4000, and 6000 IU per day orally
11991029|NCT00656006|Drug|Albuferon|
11991030|NCT00656006|Drug|Ribavirin|
11991031|NCT00655993|Drug|simvastatin|40 mg po daily
11991032|NCT00655980|Drug|Vitamin B12 and folic acid|1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
11991033|NCT00655980|Drug|Nitrous oxide and placebo|
11991034|NCT00655980|Other|standard of care|
11991113|NCT00655499|Genetic|fluorescence in situ hybridization|
11991114|NCT00655499|Genetic|gene expression analysis|
11991035|NCT00655967|Drug|Acamprosate (Campral)|"During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50.
~Treatment compliance will be monitored by counts of returned medication. Records of all concomitant medications will be taken at each study visit as well as reports of adverse events (as shown above)."
11991036|NCT00655967|Drug|Acamprosate|During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50.
11991037|NCT00655954|Procedure|Induced sputum|Used Ultrasonic nebuliser
11991038|NCT00655941|Behavioral|Dietary instruction|Weekly instruction by dieticians
11991039|NCT00655941|Other|Exercise|Supervised exercise in groups
11991040|NCT00655928|Drug|N-acetylcysteine|N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
11991041|NCT00655928|Drug|0.9% saline|0.9% saline 1 litre intravenous over 12 hours pre-operatively
11991042|NCT00655915|Other|Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine|Patients will receive a carpal tunnel injection of 1 mg of betamethasone and 1 mL of 1% lidocaine will be infiltrated by small gauge (ie. 25- or 27-gauge) needle via attending surgeon preference. These are routinely performed by injecting 1cm proximal to distal wrist crease just ulnar to palmaris longus tendon although multiple techniques have been described. Elicitation of median nerve symptoms during needle placement requires redirecting needle prior to injection to avoid median nerve infiltration.
11991043|NCT00655902|Dietary Supplement|Trans fat (soy bean oil)|Industrially produced trans fatty acid from soy bean oil (15 g/d for 16 weeks). The fat (a total of 25 g/d) will be baked into buns.
11991044|NCT00655902|Dietary Supplement|Control fat (sunflower oil)|Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.
11991045|NCT00655889|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of biopsy from palate
~Papillary priming procedure
~Seven injection treatments to target sites
~Performance of study assessments (investigator and subject)"
11991046|NCT00655876|Drug|cetuximab|Weekly with external beam radiation therapy for a total of six doses. The initial dose of cetuximab is 400 mg/m^2 intravenously administered over 120 minutes on day 1, followed by weekly infusions of 250 mg/m^2 intravenously over 60 minutes on days 8, 15, 22, 29, and 36. The infusion rate of cetuximab must never exceed 5 mL/min.
11991047|NCT00655876|Drug|cisplatin|Weekly with external beam radiation therapy for a total of six doses. Patients receive 25 mg/m^2 as an intravenous infusion over 30-60 minutes on days 1, 8, 15, 22, 29 and 36.
11991048|NCT00655876|Drug|paclitaxel|Weekly with external beam radiation therapy for a total of six doses. Patients receive 50 mg/m^2 as an intravenous infusion over 1 hour on days 1, 8, 15, 22, 29 and 36.
11991049|NCT00655876|Radiation|radiation therapy|1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.
11991050|NCT00655863|Drug|Alogliptin and Pioglitazone|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
11991051|NCT00655863|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
11991052|NCT00655863|Drug|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
11991053|NCT00655850|Drug|Paclitaxel|"Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:
~Dexamethasone 20mg, intravenously (IV)
~Diphenhydramine 50 mg IV
~Ranitidine 50 mg IV
~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.
~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)
~Paclitaxel Dose Levels:
~Dose Level 1 ________80 mg/m2/weekly
~Dose Level -1 ________70 mg/m2/weekly"
11991054|NCT00655850|Drug|Gemcitabine|"Premedication
~Prophylactic antiemetics: 5-HT3-receptor antagonist prior to infusion with gemcitabine.
~Prior to receiving paclitaxel chemotherapy
~Gemcitabine will be given at the initial dose of 200mg/m2/week (Dose Level 1) for 3 out of 4 weeks (Day 1, 8, 15), as a 30 minute (IV) infusion.
~The dose of gemcitabine can be escalated to 300mg/m2/weekly (Dose Level 2) after the first cycle of treatment if no significant toxicity is experienced.
~Gemcitabine Dose Levels:
~Dose Level 2 ________300 mg/m2/weekly
~Dose Level 1 ________200 mg/m2/weekly
~Dose Level -1 ________150 mg/m2/weekly"
11991055|NCT00655850|Biological|Avastin|"The dose of Avastin is 10 mg/kg IV every 2 weeks
~It will be administered following the administration of chemotherapy
~The first infusion will be administered over 90 minutes; if well tolerated, the second and subsequent doses will be administered as a 60-minute and 30-minute infusion, respectively.
~It should not be administered or mixed with dextrose solutions."
11991056|NCT00655837|Drug|SGN-40|4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
11991057|NCT00655837|Drug|rituximab|375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
11991058|NCT00655837|Drug|gemcitabine|1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
11991059|NCT00655824|Drug|ofatumumab|1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl
11991060|NCT00655811|Drug|Capsaicin|Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A
11991061|NCT00655811|Drug|Placebo moisturizing cream|Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
11991062|NCT00655798|Dietary Supplement|Placebo|plain yogurt and capsules containing cellulose
11991063|NCT00655798|Dietary Supplement|Plain Yogurt + mix of anti-oxidants capsules|plain yogurt and capsules containing mix of anti-oxidants
11991064|NCT00655798|Dietary Supplement|Yogurt containing Lactobacillus helveticus|Yogurt containing the probiotic Lactobacillus helveticus
11991065|NCT00655798|Dietary Supplement|Yogurt containing Bifidobacterium animalis ssp.|Yogurt containing the probiotic Bifidobacterium animalis ssp.
11991066|NCT00655785|Biological|VEGFR1-1084, VEGFR2-169|One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C
11991115|NCT00655499|Other|laboratory biomarker analysis|
11991068|NCT00655772|Other|Chlorine Dioxide|Experimental mouthwash (ClO2 Fresh®): 0.16% sodium chlorite (NaClO2) with an efficacy of 0.1% chlorine dioxide (ClO2),Placebo mouthwash: glycerin, mint oil and distilled water, contents are almost the same as those in the experimental mouthwash except ClO2.
11991069|NCT00655746|Drug|Dasatinib + Omeprazole|Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days
11991070|NCT00655733|Drug|HMPL-004|HMPL-004 1200 mg/d
11991071|NCT00655733|Drug|Placebo|Placebo 1200 mg/d
11991072|NCT00655720|Other|infant formula|"hydrolyzed infant formula without probiotics
~hydrolyzed infant formula with probiotics
~hydrolyzed infant formula with probiotics"
11991073|NCT00655707|Biological|Autologous Expanded CD34+ Haemopoietic cells|"Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
~Patient numbers 01 and 02 will receive 1x109 cells Patient numbers 03 and 04 will receive 1x1010 cells Patient numbers 05 and 06 will receive 2x1010 cells Patient numbers 07 and 08 will receive 5x1010 cells"
11991074|NCT00655694|Procedure|sputum, blood, urine, exhaled breath, lung function|
11991075|NCT00655681|Drug|pamidronate|The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children < 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume.
11991076|NCT00655681|Other|saline|receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
11991077|NCT00655668|Drug|Lenalidomide|Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
11991078|NCT00655655|Drug|everolimus|Given orally
11991079|NCT00655655|Drug|vatalanib|Given orally
11991080|NCT00655655|Other|pharmacological study|Correlative study (Cohort IIA only)
11991081|NCT00655655|Other|laboratory biomarker analysis|Correlative study (Cohorts IIA and IIB)
11991082|NCT00655655|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Correlative study (Cohort IIA only)
11991083|NCT00655655|Procedure|ultrasound imaging|Correlative study (Cohorts IIA and IIB)
11991084|NCT00655642|Drug|Ondansetron|4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
11991085|NCT00655642|Drug|Metoclopramide|10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
11991086|NCT00655642|Drug|Promethazine|12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
11991087|NCT00655642|Drug|Normal Saline|Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter
11991088|NCT00655629|Drug|Vardenafil ODT (STAXYN, BAY38-9456)|Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)
11991089|NCT00655629|Drug|Placebo|Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
11991090|NCT00655616|Drug|Montelukast Placebo|"Seretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
~Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
~Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
~Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily"
11991091|NCT00655616|Drug|Salmeterol, Montelukast|"Flixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast
~Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
~Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
~Flixotide Accuhaler 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
~Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily"
11991092|NCT00655603|Other|Infusion of native hormones from the pancreas and gut (GLP-1)|Glucose-clamps at fasting levels during infusion of hormones in different combinations.
11991093|NCT00655590|Drug|Levitra (Vardenafil, BAY38-9456)|20 mg daily dosing
11991094|NCT00655590|Drug|Sildenafil|100 mg daily dosing
11991095|NCT00655590|Drug|Placebo|Matching placebos
11991096|NCT00655577|Behavioral|Exercise|Supervised, mainly home-based balance, strength and jumping exercises
11991097|NCT00655564|Drug|Alefacept|"Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
~Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose)."
11991098|NCT00655551|Drug|lacosamide|Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days
11991099|NCT00655551|Drug|lacosamide|Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days
11991100|NCT00655551|Drug|lacosamide|Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days
11991101|NCT00655538|Drug|Placebo|po daily for 36 weeks
11991102|NCT00655538|Drug|dalcetrapib|600mg po daily for 36 weeks
11991103|NCT00655525|Dietary Supplement|fish oil|2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months
11991104|NCT00655525|Dietary Supplement|placebo|placebo administered orally every day for 3 months
11991105|NCT00655512|Drug|pimecrolimus 1% cream|twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
11991106|NCT00655512|Drug|hydrocortisonacetat 1% cream|twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
11991107|NCT00655512|Drug|betamethasonvalerat 0,1% cream|twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
11991108|NCT00655512|Drug|clobetasol-17-propionat 0,05% cream|twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
11991109|NCT00655512|Drug|Placebo|twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
11991116|NCT00655486|Drug|lacosamide|Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
11991117|NCT00655473|Drug|Dalcetrapib (RO4607381)|600mg po daily for 24 months
11991118|NCT00655473|Drug|Placebo|po daily for 24 months
11991119|NCT00655460|Procedure|glucose control with computer generated recommendations|Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.
11991120|NCT00655421|Other|Unaided Visual Inspection|Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
11991121|NCT00655421|Device|VelScope|Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
11991122|NCT00655421|Other|Toluidine Blue Assisted Oral Examination|Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker
11991123|NCT00655408|Drug|elemental iron|Iron supplementation.
11991124|NCT00655395|Drug|Laromustine (VNP40101M) and Ara-C|"Laromustine 300 mg/m2 (cohort 1), 400 mg/m2 (cohort 2), 500 mg/m2 (cohort 3) IV on day 1 over 30 - 60 minutes. Laromustine will be administered approximately 3-4 hours following the start of infusional Ara C.
~Ara C at 100 mg/m2/day as a continuous infusion daily for 7 days. Appropriate antiemetics are given during the Ara C infusion."
11991125|NCT00655369|Drug|PD 0200390|oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
11991126|NCT00655369|Drug|PD 0200390|oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
11991127|NCT00655369|Drug|PD 0200390|oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
11991128|NCT00655369|Drug|PD 0200390|oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
11991129|NCT00655369|Drug|PD 0200390|oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
11991130|NCT00655369|Drug|Placebo|oral placebo daily dose, 3 capsules per dose during a six week treatment period.
11991131|NCT00655356|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of 3 mm post auricular skin punch biopsies.
~Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face."
11991132|NCT00655356|Biological|Placebo|"Collection of 3 mm post auricular skin punch biopsies.
~Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face."
11991133|NCT00655343|Drug|ATG-Fresenius S|"20 mg rabbit immunoglobulin (IgG) in 1 ml of sterile solution
~20 mg/kg body weight per day diluted in 500 ml physiological saline, slow intravenous infusion at days -3, -2, -1 prior to transplantation"
11991134|NCT00655330|Drug|Valsartan|Valsartan (160mg/day)
11991135|NCT00655330|Drug|Placebo|Placebo
11991136|NCT00655330|Drug|Probucol|Probucol (750mg/day)
11991137|NCT00655317|Other|Acupuncture|Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
11991138|NCT00655317|Other|Sham acupuncture|SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
11991139|NCT00655304|Device|Prometheus (R) liver support dialysis|6-8 hours of dialysis
11991140|NCT00655304|Device|CVVHDF (Continuously Veno-Venous Hemodiafiltration)|6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).
11991141|NCT00655291|Drug|XP20B|
11991142|NCT00655291|Drug|Placebo|
11991143|NCT00655278|Drug|T2000|T2000 at previous most effective, well-tolerated dose (600-1000mg daily)
11991144|NCT00655265|Drug|Colesevelam hydrochloride film-coated tablets|tablets
11991145|NCT00655265|Drug|Placebo|Tablets
11991146|NCT00655252|Drug|Everolimus|
11991147|NCT00655239|Behavioral|Neuroadaptive cognitive training|Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
11991148|NCT00655239|Behavioral|Computer games|The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks.
11991149|NCT00655226|Behavioral|Hepatitis C educational support groups|Hepatitis C educational support groups
11991150|NCT00655226|Behavioral|Cognitive Behavioral Therapy skills based group sessions|Eight CBT group sessions tailored for hepatitis C patients conducted by a clinical psychologist: 3 sessions conducted prior to IFN/ribavirin initiation, 1 session the day of IFN/ribavirin initiation, and 4 sessions during IFN/ribavirin treatment.
11991151|NCT00655213|Device|Symphony D 2450|
11991152|NCT00655213|Device|Symphony DR 2550|
11991153|NCT00655200|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
11991154|NCT00655187|Other|Collection of information|Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.
11991155|NCT00655187|Procedure|Collection of stool samples|Stools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples.
11991156|NCT00655174|Drug|fluvoxamine|Children will be started on 12.5 mg. If there is no therapeutic effectivenss observed after eight weeks, then the child may have their dose increased. In this case, the child will be followed for an additional eight weeks.
11991157|NCT00655174|Drug|sertraline|Children will be started on 12.5 mg. If there is no therapeutic effectivenss observed after eight weeks, then the child may have their dose increased. In this case, the child will be followed for an additional eight weeks.
11991158|NCT00655174|Drug|Placebo|Patients in this study arm will receive capsules that appear identical to those of the two study drugs but will contain no active ingredient.
11991159|NCT00655161|Biological|GI-4000|subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence
11991160|NCT00655148|Biological|DTaP-IPV vero vaccine|DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
11991161|NCT00655148|Biological|DTaP-IPV mkc vaccine|DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
11991250|NCT00654511|Drug|Fentanyl|Fentanyl 1mcg/kg, Intravenous (IV)
11991162|NCT00655135|Drug|LDP-02|Each patient in arms 2 & 3 received a single IV dose of study drug at 0.5 or 2.0 mg/kg LDP-02 on Days 1 and 29.
11991163|NCT00655135|Drug|Placebo|Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.
11991164|NCT00655122|Drug|Dalteparin sodium|Dalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
11991165|NCT00655122|Drug|Placebo|Placebo was administered with a daily injection of 0.2 mL by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
11991166|NCT00655109|Drug|Olopatadine|Ophthalmic solution
11991167|NCT00655109|Drug|Fluticasone|Nasal spray
11991168|NCT00655109|Drug|Saline|Nasal spray
11991169|NCT00655109|Drug|Artificial tears|Ophthalmic Solution
11991170|NCT00655083|Drug|Nepadutant|0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
11991171|NCT00655083|Drug|Nepadutant|0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
11991172|NCT00655070|Device|Timi3 Transthoracic ultrasound|Low frequency ultrasound over the chest using Timi3 ultrasound device
11991173|NCT00655057|Drug|S-citalopram|Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.
11991174|NCT00655057|Behavioral|Cognitive behavioral therapy (CBT)|Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.
11991175|NCT00655057|Procedure|TRODAT-1 single photon emission computed tomographic (SPECT) imaging|Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later.
11991176|NCT00655044|Drug|insulin detemir|Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.
11991177|NCT00655031|Dietary Supplement|Pomegranate Concentrate (POMx)|3.3 oz bottle containing antioxidants equivalent to 8 oz of pomegranate juice taken once daily for 7 days prior to infection and for 4 days after.
11991178|NCT00655031|Dietary Supplement|Placebo|3.3 oz bottle containing fruit flavored juice low in antioxidants taken once daily for 7 days prior to infection and for 4 days after.
11991179|NCT00655018|Dietary Supplement|Vitamin treatment (alpha tocopherol plus ascorbic acid)|alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention [hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
11991180|NCT00655018|Dietary Supplement|Placebo|placebo and lifestyle intervention [hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
11991181|NCT00655005|Other|questionnaire administration|Newly diagnosed HNC patients
11991182|NCT00655005|Procedure|quality-of-life assessment|following treatment
11991183|NCT00654992|Drug|Erythropoietin-Beta|300 IU/kg of EPO or saline intravenously before surgery
11991184|NCT00654992|Drug|Normal Saline|300 IU/kg of normal saline intravenously before surgery
11991185|NCT00654979|Device|SafeFlo IVC Filter|SafeFlo IVC Filter
11991186|NCT00654966|Drug|Urotensine II|A few drops of the drug will be administered to the skin by iontophoresis.
11991187|NCT00654966|Drug|Soluble epoxide hydrolase|A few drops of the drug will be administered to the skin by iontophoresis.
11991188|NCT00654953|Drug|sertraline|Sertraline hydrochloride (200 mg/day) will be administered once daily. While subjects are at RCA-NLR they initially receive 50 mg/day of sertraline. This dose is gradually increased over a 3-week period until subjects receive 200 mg. When subjects are transferred to the outpatient program, they will be administered capsules once weekly, with take-home doses given in blister packs to take once a day for the rest of the week.
11991189|NCT00654953|Drug|Placebo|Placebo (cellulose or lactose) administered twice per day for 12 weeks.
11991190|NCT00654953|Drug|gabapentin|Gabapentin (Neurontin; Parke-Davis; 1200 mg/day) will be administered twice daily. Initially, patients will receive 200 mg twice daily on days 1-5, 400 mg twice daily on days 6-10, then 600 mg twice daily on days 11 on. Subjects are then maintained on this dose for the duration of the trial, unless side-effects are too severe, in which case the dose of gabapentin is decreased to no less 800 mg/day. If symptoms persist, subjects' participation would then be terminated.
11991191|NCT00654940|Drug|Pregabalin (Lyrica)|Oral, 75mg or 150mg capsules, BID
11991192|NCT00654940|Drug|Placebo|Oral, matched capsules, BID
11991193|NCT00654927|Drug|Fampridine-SR b.i.d. (Twice Daily)|Dosage form - tablets.
11991194|NCT00654914|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg per dose of vardenafil for the first four weeks. A further 8 weeks ( in two treatment periods of four weeks, respectively) where patients will either maintain the previous dosage regimen or will step up to 20 mg per dose of vardenafil or will step down to 5 mg per dose of vardenafil, at interval visits of four weeks .
11991195|NCT00654901|Biological|DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)|0.5 mL, Intramuscular
11991196|NCT00654901|Biological|DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)|0.5 mL, Intramuscular
11991197|NCT00654901|Biological|DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)|0.5 mL, Intramuscular
11991198|NCT00654901|Biological|Infanrix Hexa™|0.5 mL, Intramuscular
11991199|NCT00654888|Procedure|ALK (automated lamellar keratectomy)|ALK is performed with a microkeratome, to make a free cap.
11991200|NCT00654888|Drug|Mitomycin|mitomycin 0,02%, 30 seconds after ALK
11991201|NCT00654875|Drug|Aliskiren|Aliskiren supplied in 150 mg and 300 mg tablets.
11991202|NCT00654875|Drug|Placebo to Aliskiren|Placebo to Aliskiren matching 150 and 300 mg tablets
11991203|NCT00654862|Dietary Supplement|cocoa polyphenols|Oral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo
11991204|NCT00654862|Dietary Supplement|cocoa polyphenols|Oral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo
11991205|NCT00654849|Procedure|Plasmakinetic bipolar energy forceps|Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy
11991206|NCT00654849|Procedure|Abdominal Hysterectomy with traditional suture technique|The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.
11991207|NCT00654836|Biological|bevacizumab|Participants will receive bevacizumab 15 mg/kg on days 1,22, and 43.
11991208|NCT00654836|Drug|Carboplatin|Participants will receive a standard carboplatin dose according to their area under the plasma drug concentration-time curve (AUC-6) on days 1, 22, and 43.
11991209|NCT00654836|Drug|ABI-007|Participants will receive ABI-007 (Abraxane) 100mg/m2 on days 1,8, 15, 22, 29, 36,43,and 50.
11991210|NCT00654810|Behavioral|Walking Exercise|Intermittent treadmill walking to near maximal claudication pain three days per week
11991211|NCT00654797|Procedure|glucose control with computer generated recommendations|Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.
11991212|NCT00654784|Drug|idebenone|idebenone 450 mg/day (150 mg three times a day)
11991213|NCT00654784|Drug|placebo|
11991214|NCT00654771|Other|urine collection|clean catch urine collection and catheterized urine collection
11991215|NCT00654758|Drug|M200 (Volociximab), Carboplatin, Paclitaxel|Volociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
11991216|NCT00654745|Drug|Amlodipine|Amlodipine 5 mg tablets , Daily for 3 weeks;
11991217|NCT00654745|Drug|amlodipine / olmesartan medoxomil combination|amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg
11991218|NCT00654745|Drug|Hydrochlorothiazide|hydrochlorothiazide tablets, 12.5 mg or 25 mg.
11991219|NCT00654732|Drug|Bleomycin|Given IV
11991220|NCT00654732|Drug|Dacarbazine|Given IV
11991221|NCT00654732|Drug|Doxorubicin Hydrochloride|Given IV
11991222|NCT00654732|Biological|Rituximab|Given IV
11991223|NCT00654732|Drug|Vinblastine|Given IV
11991224|NCT00654719|Dietary Supplement|NutriDrink|Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
11991225|NCT00654719|Dietary Supplement|Placebo|Nutritional supplementation containing only 12 kcal/day
11991226|NCT00654706|Drug|Sertindole|Once daily oral dose. Day 1-20: 4-16 mg/day (titration period). Day 21-84: 12, 16 or 20 mg/day (flexible treatment period).
11991227|NCT00654706|Drug|Quetiapine|Twice daily oral dose. Day 1-20: 50-500 mg/day (titration period). Day 21-84: 400, 500 or 600 mg/day (flexible treatment period).
11991228|NCT00654693|Other|Rapid Response Team|If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.
11991229|NCT00654680|Drug|Vardenafil (Levitra, BAY38-9456)|5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse
11991230|NCT00654680|Drug|Placebo|Matching placebo
11991231|NCT00654667|Drug|Placebo|Placebo, no active drug, take 5 capsules by mouth daily for one month
11991232|NCT00654667|Drug|Resveratrol|
11991233|NCT00654654|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of 3 mm biopsies
~Two injection treatments of facial wrinkles and creases
~Conduct of study assessments"
11991234|NCT00654641|Procedure|Negative pressure wound closure|Applying negative pressure to primary wound closure
11991235|NCT00654641|Procedure|Standard wound closure|Standard wound closure
11991236|NCT00654628|Drug|ezetimibe (+) simvastatin|Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.
11991237|NCT00654615|Device|Intramedullary Radius Fixation (Micronail)|After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing.
11991238|NCT00654615|Procedure|Volar Plate Fixation|After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied.
11991239|NCT00654602|Drug|Rosuvastatin|
11991240|NCT00654602|Behavioral|Maintenance of specific diet|
11991241|NCT00654589|Drug|Deferasirox|
11991242|NCT00654576|Drug|Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole|patient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment.
11991243|NCT00654576|Behavioral|psychosocial intervention|the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
11991244|NCT00654550|Drug|Nexagon™ or Nexagon™ vehicle|Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
11991245|NCT00654537|Drug|Rosuvastatin|
11991246|NCT00654537|Drug|Atorvastatin|
11991247|NCT00654537|Drug|Pravastatin|
11991248|NCT00654537|Drug|Simvastatin|
11991249|NCT00654524|Drug|gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin|The patient will be managed with GnRH-a injection (Goserelin 3.6mg) every 4 weeks for 6 months plus add-back therapy (Caltrate With Vitamin D 600mg p.o. q.d.& Livial 1.25-2.5mg p.o. q.d.) if needed.
11991253|NCT00654511|Drug|Dexmedetomidine|Dexmedetomidine, 4mcg/kg Intravenous (IV)
11991254|NCT00654498|Drug|Pramipexole|
11991255|NCT00654498|Drug|Placebo|
11991256|NCT00654485|Drug|Rosuvastatin|
11991257|NCT00654485|Drug|Atorvastatin|
11991258|NCT00654459|Dietary Supplement|Mixture of Berberine, Policosanol, Red Yeast, Placebo|A tablet one a day for 6 weeks
11991259|NCT00654446|Drug|Rosuvastatin|
11991260|NCT00654446|Drug|Simvastatin|
11991261|NCT00654433|Biological|ALD-101|A subpopulation of cord blood cells composed of cells that express a high level of the intracellular enzyme aldehyde dehydrogenase (ALDH).
11991262|NCT00654420|Drug|Dalotuzumab|Dalotuzumab 20 mg/mL in sterile solution. Intravenous (IV) infusion over 60 minutes at 5 mg/kg, administered weekly at dosage according to treatment group.
11991263|NCT00654420|Drug|Erlotinib|Open-label erlotinib administrated orally (tablets) by mouth (PO) at 150 mg daily.
11991264|NCT00654407|Drug|Rosuvastatin|
11991265|NCT00654407|Drug|Atorvastatin|
11991266|NCT00654407|Drug|Simvastatin|
11991267|NCT00654394|Drug|Rosuvastatin|
11991268|NCT00654381|Drug|BI 1356|5 mg/daily
11991269|NCT00654381|Drug|BI 1356|10 mg/daily
11991270|NCT00654381|Drug|voglibose placebo|three times daily
11991271|NCT00654381|Drug|BI 1356 placebo|once daily
11991272|NCT00654381|Drug|voglibose|0.6 mg/daily
11991273|NCT00654368|Biological|Etanercept|Commercially available etanercept administered subcutaneously at 50 mg/week.
11991274|NCT00654368|Drug|Methotrexate|Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)
11991275|NCT00654355|Drug|tacrolimus ointment|tacrolimus ointment to be applied twice daily to affected areas during duration of study
11991276|NCT00654342|Procedure|Intraoperative injection (in vivo)|Intraoperative injection
11991277|NCT00654342|Procedure|Postoperative injection (ex vivo)|postoperative injection
11991278|NCT00654329|Drug|Saline|Normal saline, given intranasally
11991279|NCT00654329|Drug|Fentanyl|Fentanyl, nasal transmucosal, 2 micrograms/kilogram
11991280|NCT00654329|Drug|Dexmedetomidine|Dexmedetomidine, transmucosal, 1 microgram/kilogram
11991281|NCT00654329|Drug|Dexmedetomidine|Dexmedetomidine, 2 microgram/kilogram, transmucosal route
11991282|NCT00654316|Biological|BCG|intradermal injection of 0.1ml BCG over the deltoid muscle
11991283|NCT00654303|Drug|Rosuvastatin|
11991284|NCT00654290|Drug|Amiodarone + Propranolol|Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
11991285|NCT00654290|Drug|Amiodarone|Amiodarone treated 7 days pre-operation to 5 days post CABG
11991286|NCT00654290|Drug|Propranolol|Propranolol from 7 days pre-operation to 5 days post CABG
11991287|NCT00654277|Drug|Ondansetron|ODT, 8 mg, single-dose
11991288|NCT00654277|Drug|Zofran|ODT, 8 mg, fasting conditions
11991289|NCT00654264|Procedure|Water immersion|Subjects will sit in tub for four hours.
11991290|NCT00654238|Drug|sorafenib|400mg PO BID daily
11991291|NCT00654225|Drug|Rosuvastatin|
11991292|NCT00654225|Drug|Atorvastatin|
11991293|NCT00654212|Procedure|endo-laparoscopic approach|endoluminal stenting followed by laparoscopic resection
11991294|NCT00654212|Procedure|open approach|emergency open surgery
11991295|NCT00654186|Drug|Revlimid|25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
11991296|NCT00654173|Drug|Rosuvastatin|
11991297|NCT00654173|Drug|Simvastatin|
11991298|NCT00654173|Drug|Atorvastatin|
11991299|NCT00654160|Drug|fluorouracil|
11991300|NCT00654160|Drug|irinotecan hydrochloride|
11991301|NCT00654160|Drug|leucovorin calcium|
11991302|NCT00654160|Other|pharmacogenomic studies|
11991303|NCT00654160|Other|pharmacological study|
11991304|NCT00654147|Drug|Raltegravir & Lopinavir/ritonavir|Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor
11991305|NCT00654147|Drug|Raltegravir and emtricitabine/tenofovir|Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors
11991306|NCT00654134|Biological|Clinical Center Reference Endotoxin|20,000 EU inhaled
11991307|NCT00654121|Drug|Actrapid HM|56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
11991308|NCT00654108|Drug|Ciprofloxacin 500 mg|500 milligrams(mg) will be administered orally twice daily for 5 days.
11991309|NCT00654108|Biological|Peru-15-pCTB|Live attenuated oral combined ETEC-cholera (Peru-15 pCTB) vaccine co-administered with bicarbonate buffer solution; vaccine dose levels 1 X 10^7; 1 X 10^8; 1 X 10^9; and 1 X 10^10.
11991310|NCT00654108|Drug|Placebo|Buffer solution: 2.5 grams (g) Sodium Bicarbonate powder, 1.65 g Ascorbic Acid and 25 mg Aspartame, in 100 milliliters (mL) water for injection.
11991311|NCT00654095|Drug|Ezetimibe|Ezetimibe 10 mg once daily
11991312|NCT00654095|Drug|atorvastatin|atorvastatin 20 mg once daily
11991313|NCT00654082|Drug|sildenafil|sildenafil 50 mg tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks; after 2 weeks on treatment, doses could be escalated to 100 mg or reduced to 25 mg
11991314|NCT00654082|Drug|placebo|placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks
11991315|NCT00654069|Drug|Placebo|2 tablets every 6 hours for 48 hours
11991316|NCT00654069|Drug|Acurox 5/30 mg|2 tablets every 6 hours for 48 hours
11991317|NCT00654069|Drug|Acurox 7.5/30|2 tablets every 6 hours for 48 hours
11991318|NCT00654056|Drug|Actrapid (human insulin)|On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours
11991319|NCT00654043|Drug|Torsemide|tablets, 20 Mg, single-dose
11991320|NCT00654043|Drug|Demadex|Tablets, 20 mg, single-dose
11991321|NCT00654030|Drug|1650-G Vaccine|.6ml injection administered intradermally in the thigh at week 0 and week 4
11991322|NCT00654017|Drug|placebo|Placebo comparator to be given per protocol.
11992165|NCT00648440|Drug|Midodrine HCl Tablets 5 mg|5mg, single dose fed
11991323|NCT00654017|Drug|sildenafil|oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability
11991324|NCT00653991|Behavioral|SOLVE-IT|SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context.
11991325|NCT00653978|Procedure|ERCP plus one biliary stent|ERCP ＋ one biliary stent insertion
11991326|NCT00653978|Procedure|ERCP plus two biliary stents|ERCP ＋ two biliary stents insertion
11991327|NCT00653965|Drug|Rosuvastatin|
11991328|NCT00653965|Drug|Atorvastatin|
11991329|NCT00653952|Drug|CAELYX|Dose of 50 mg/m2 by i.v. infusion over 1 hour every 28 days for up to 1 year
11991330|NCT00653952|Drug|Paclitaxel HCl|Dose of 175 mg/m2 by i.v. infusion over 3 hours starting on Day 1 of a 21-day cy
11991331|NCT00653939|Drug|Fosbretabulin|Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
11991332|NCT00653939|Drug|Carboplatin|Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
11991333|NCT00653939|Drug|Paclitaxel|Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
11991334|NCT00653939|Drug|Bevacizumab|Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
11991335|NCT00653926|Drug|ropivacaine, ketorelac and epinephrine|In Group A, 200 mg ropivicaine, 30 mg ketorelac and 0.5 mg epinephrine (total volume 106 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue After 21 postoperative hours in Group A, 150 mg ropivicaine, 30 mg ketorelac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
11991336|NCT00653926|Drug|saline|In Group P (placebo) no injections were given intaoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.
11991337|NCT00653913|Drug|SCH 58235|SCH 58235 10 mg (once daily)
11991338|NCT00653913|Drug|pitavastatin|Pitavastatin 2 mg (once daily)
11991339|NCT00653887|Other|Biofeedback|4 sessions of biofeedback one session each week
11991340|NCT00653887|Other|Placebo|4 sessions, one each week, of discussion about anorectal disease
11991341|NCT00653874|Device|BiliChek (jaundice assessment)|assessment of jaundice was done by either transcutaneous bilirubinometry (TcB) method or by clinical assessment of bilirubin (CaB)
11991342|NCT00653874|Procedure|Transcutaneous bilirubinometry (TcB)|transcutaneous bilirubinometry was used for jaundice assessment in healthy term and near-term jaundiced neonates between 24 to 168 hours of life
11991343|NCT00653874|Other|Clinical asessment of bilirubin (CaB)|Clinical assessment of bilirubin (CaB) was used for jaundice assessment in healthy term and near-term jaundiced neonates between 24 to 168 hours of life
11991344|NCT00653861|Device|JUVÉDERM™ Injectable Gel with Lidocaine|Single treatment, volume determined by investigator
11991345|NCT00653861|Device|JUVÉDERM™ Injectable Gel|Single treatment, volume determined by investigator
11991346|NCT00653848|Drug|docetaxel|docetaxel 75 mg/square meter i.v. every third week, six cycles
11991347|NCT00653835|Drug|Ezetimibe + Simvastatin|oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
11991348|NCT00653835|Drug|Simvastatin|oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
11991349|NCT00653822|Drug|alefacept|IC and SC
11991350|NCT00653822|Drug|placebo|IV and SC
11991351|NCT00653796|Drug|Ezetimibe + Atorvastatin|oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
11991352|NCT00653796|Drug|Atorvastatin|oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
11991353|NCT00653770|Biological|FP85A|Recombinant Fowlpox virus 9 expressing antigen 85A from M. tuberculosis (5 x10^7 pfu)
11991354|NCT00653770|Biological|MVA85A|Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis (5 x 10^7 pfu)
11991355|NCT00653757|Drug|goserelin acetate|
11991356|NCT00653757|Drug|leuprolide acetate|
11991357|NCT00653757|Radiation|image-guided radiation therapy|
11991358|NCT00653757|Radiation|intensity-modulated radiation therapy|
11991359|NCT00653744|Drug|Rosuvastatin|
11991360|NCT00653744|Drug|Atorvastatin|
11991361|NCT00653731|Behavioral|Snoezelen ©|Nursing individual intervention one time a week for 20 minutes
11991362|NCT00653731|Behavioral|structured reminiscence therapy|Individual nursing intervention: one time a week 20 minutes
11991363|NCT00653731|Behavioral|10-minutes activation|Individual nursing intervention: two times a week for 10 minutes
11991364|NCT00653731|Behavioral|Unstructured verbal communication|Individual nursing intervention: one time a week for 20 minutes
11991365|NCT00653705|Other|Yogurt drink with probiotic bacteria BB12|Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
11991366|NCT00653705|Other|Placebo|Vanilla flavored dairy drink. One bottle a day for 16 weeks.
11991367|NCT00653679|Other|exercise|1 hour of endurance or resistance exercise
11991368|NCT00653666|Other|Medically supervised fasting|Metabolic fasting studies will be conducted over an 18-hour period or until blood glucose is < 40 mg/dl. If the YSI reading is 40 mg/dl or less, at any time during the study, then a blood sample will be collected, and the fast terminated by giving D25W IV and then feeding orally.
11991369|NCT00653640|Procedure|body weight supported treadmill training|BWSTT for 12 weeks, 3 times per week
11991370|NCT00653640|Procedure|traditional physical therapy|traditional PT for 12 weeks, 3 times per week
11991371|NCT00653627|Biological|BCG|Mycobacterium bovis Bacille Calmette-Guerin
11991372|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)|Single dose administration of E2 + DRSP as a tablet
11991373|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 2 (80458739)|Single dose administration of E2 + DRSP as a tablet
11991488|NCT00652899|Radiation|total-body irradiation|200 cGy Day 1 preceding natural killer cell infusion.
11991374|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 3 (80458755)|Single dose administration of E2 + DRSP as a tablet
11991375|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 4 (80458720)|Single dose administration of E2 + DRSP as a tablet
11991376|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 5 (80458712)|Single dose administration of E2 + DRSP as a tablet
11991377|NCT00653614|Drug|DRSP (ZK 30595) dose 1 (SH T04984F)|Single dose administration of DRSP as a tablet
11991378|NCT00653614|Drug|DRSP (ZK 30595) dose 2 (80458690)|Single dose administration of DRSP as a tablet
11991379|NCT00653614|Drug|Placebo|Placebo administration in each arm
11991380|NCT00653588|Drug|Rosuvastatin|40mg
11991381|NCT00653588|Drug|Atorvastatin|80mg
11991382|NCT00653575|Behavioral|Information-Motivation-Behavioral Skills model|The Information-Motivation-Behavioral Skills model is an influential and empirically supported theory of health behavior. The model suggests that HIV-related information, motivation, and behavioral skills are important determinants of sexual behavior; thus, childhood sexual abuse may lead to deficits in these areas. This model will be used to guide research interviews.
11991383|NCT00653575|Behavioral|Traumagenic Dynamics model|The Traumagenic Dynamics model is an influential and empirically supported model of the effects of childhood sexual abuse. The model suggests that childhood sexual abuse leads to traumatic sexualization, stigmatization, betrayal, and powerlessness and that these four traumagenic dynamics lead to adverse outcomes, including increased rates of sexual risk behavior. This model will be used to guide research interviews.
11991384|NCT00653562|Drug|zolpidem|Oral
11991385|NCT00653549|Drug|Torsemide|Tablets, 20 mg, single-dose
11991386|NCT00653549|Drug|Demadex|tablets, 20 mg, single-dose
11991387|NCT00653536|Device|NeuroFlo|The device will be inflated for 45 minutes in acute ischemic stroke patients who have failed mechanical recanalization.
11991388|NCT00653523|Drug|Ezetimibe|Ezetimibe 10 mg once daily
11991389|NCT00653523|Drug|Simvastatin|Simvastatin 20 mg daily
11991390|NCT00653510|Drug|Actrapid (human insulin)|On day one the patients will receive glucose and insulin in order to reach a blood sugar around 18 and 20 mmol/L and on day two the patients will receive glucose and insulin in order to have a blood sugar around 5 and 7 mmol/L. On both days amino acid, lipid and glucose metabolism will be assessed by means of whole body isotope dilution.
11991391|NCT00653497|Behavioral|Aquatic exercise|"Arthritis Foundation Aquatics Program
~community-based aquatic exercise program
~participants asked to attend 2 classes per week for 20 weeks
~each class 45-60 minutes in duration"
11991392|NCT00653484|Behavioral|Physical Activity|
11991393|NCT00653484|Behavioral|Energy Restriction|
11991394|NCT00653484|Behavioral|Physical Activity and Energy Restriction|
11991395|NCT00653471|Device|Microcapmicro-stream device with Smart CapnoLine Plus|nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring
11991396|NCT00653471|Device|Microcap micro-stream device with CapnoLine|CO2 measured via nasal cannula
11991397|NCT00653471|Device|TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).|CO2 measured via nasal cannula
11991398|NCT00653458|Drug|Ondansetron|ODT, 8 mg, single-dose, fed conditions
11991399|NCT00653458|Drug|Zofran|ODT, 8 mg, single-dose, under fed conditions
11991400|NCT00653445|Drug|Rosuvastatin|40mg
11991401|NCT00653445|Drug|Ezetimibe|10mg
11991402|NCT00653432|Device|Monovisc®|Intra-articular injection
11991403|NCT00653432|Other|Saline|0.9% Sterile Saline
11991404|NCT00653419|Drug|buspirone HCl|Tablets, 30 mg, single-dose
11991405|NCT00653419|Drug|Buspar|Tablets, 30 mg, single-dose
11991406|NCT00653406|Drug|Risperidone long acting injectable|
11991407|NCT00653393|Drug|Tranylcypromine|Tablets, 10 mg, single-dose
11991408|NCT00653393|Drug|Parnate|Tablets, 10 mg, single-dose
11991409|NCT00653380|Drug|Doxycycline Monohydrate|Capsules, 100 mg, single-dose
11991410|NCT00653380|Drug|Monodox|Capsules, 100 mg, single-dose
11991411|NCT00653367|Procedure|Nerve section|Intercostal nerve is divided during surgery
11991412|NCT00653354|Drug|valdecoxib|valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
11991413|NCT00653354|Drug|valdecoxib/placebo|valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
11991414|NCT00653354|Drug|placebo|placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
11991415|NCT00653341|Drug|insulin glargine|
11991416|NCT00653341|Drug|NPH human insulin|
11991417|NCT00653328|Drug|atrasentan hydrochloride|Atrasentan 10 mg orally everyday continuously beginning on Day 1.
11991418|NCT00653328|Drug|doxil|50 mg/m2 intravenously every 28 days
11991419|NCT00653315|Drug|Tramadol APAP|Tablets, 37.5mg/325mg, single dose
11991420|NCT00653315|Drug|Ultracet|Tablets, 37.5mg/325mg
11991421|NCT00653302|Drug|Lantus (insulin glargine) + Glucophage (Metformin)|
11991422|NCT00653276|Drug|ezetimibe|ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
11991423|NCT00653276|Drug|Comparator: cyclosporine|single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
11991424|NCT00653250|Drug|celecoxib|400 mg P.O. BID for five days prior to obtaining second serum/urine collection (starting after initial biopsy, serum and urine collection)
11991425|NCT00653250|Procedure|biopsy|in patients with newly diagnosed NSCLC, a pretreatment excision of a small amount of tumor tissue
11991426|NCT00653250|Procedure|therapeutic conventional surgery|surgery to remove the lung tumor
11991427|NCT00653237|Device|I-gel and LMA Supreme: supraglottic airway devices|Insertion of a supraglottic airway device
11991428|NCT00653224|Drug|levocetirizine dihydrochloride|5 mg daily (oral tablet) for 14 days
11991429|NCT00653224|Drug|placebo|0 mg daily (matching oral tablet) for 14 days
11991430|NCT00653198|Other|No intervention|
11991431|NCT00653185|Drug|SYR-472|SYR-472 25 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
11991432|NCT00653185|Drug|SYR-472|SYR-472 50 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
11991433|NCT00653185|Drug|SYR-472|SYR-472 100 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
11991434|NCT00653185|Drug|SYR-472|SYR-472 200 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
11991435|NCT00653185|Drug|Placebo|SYR-472 placebo-matching tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
11991436|NCT00653172|Drug|NXL103|600mg orally twice daily
11991437|NCT00653172|Drug|comparator|comparator twice daily
11991438|NCT00653172|Drug|NXL103|500mg orally twice daily
11991439|NCT00653159|Device|Levonorgestrel-releasing intrauterine device (LNG-IUS)|Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
11991440|NCT00653159|Device|Copper T380A intrauterine device (CuT380A)|Teens are randomly assigned to Copper T380 after the screening visit
11991441|NCT00653146|Behavioral|Mindfulness-Based Stress Reduction|In the intervention program, a variety of mindfulness meditation techniques will be taught, including the body scan, awareness of breathing, mindful yoga, eating meditation and walking meditation.
11991442|NCT00653146|Behavioral|Healthy Lifestyles|In the control condition, information on healthy lifestyles will be presented in a didactic fashion. Session topics include diet and nutrition, physical activity, and healthy behaviors to prevent cardiovascular disease and cancer.
11991443|NCT00653133|Device|Ultrasound imaging|Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
11991444|NCT00653133|Device|Peripheral nerve stimulator|either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic
11991445|NCT00653120|Drug|Propranolol|ER capsules, 160 mg, single-dose
11991446|NCT00653120|Drug|Inderal-LA|ER capsules, 160 mg, single-dose
11991447|NCT00653107|Procedure|Stent insertion|Self-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®.
11991448|NCT00653107|Radiation|Brachytherapy|a flexible applicator (with a diameter adapted to the stent's diameter) will be introduced into the oesophagus, so the applicator will be lying in the middle of the lumen of the stent. Thereafter, the flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (> 12 Gy/h).
11991449|NCT00653107|Radiation|Brachytherapy|a flexible applicator will be introduced into the oesophagus. The flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (> 12 Gy/h).
11991450|NCT00653094|Device|Halevy kit|the use of Halevy kit in Crohn patients with Fistulas
11991451|NCT00653081|Procedure|Physical therapy method called Supervised Exercises|Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
11991452|NCT00653081|Procedure|Radial Extracorporeal Shockwave Therapy|Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
11991453|NCT00653068|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
11991454|NCT00653068|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSC rescue
11991455|NCT00653068|Drug|Carboplatin|Given IV
11991456|NCT00653068|Drug|Cisplatin|Given IV
11991457|NCT00653068|Drug|Cyclophosphamide|Given IV
11991458|NCT00653068|Drug|Etoposide|Given IV
11991459|NCT00653068|Biological|Filgrastim|Given IV or SC
11991460|NCT00653068|Other|Laboratory Biomarker Analysis|Correlative studies
11991461|NCT00653068|Drug|Leucovorin Calcium|Given IV or PO
11991462|NCT00653068|Drug|Methotrexate|Given IV
11991463|NCT00653068|Drug|Thiotepa|Given IV
11991464|NCT00653068|Drug|Vincristine Sulfate|Given IV
11991465|NCT00653055|Drug|Cabergoline|Tablets, 0.5 mg (2 x 0.5 mg dose),fasting
11991466|NCT00653055|Drug|Dostinex|Tablets, 0.5 mg (2 x 0.5 mg dose), fasting
11991467|NCT00653042|Drug|Nesiritide|
11991468|NCT00653016|Drug|norelgestromin; ethinyl estradiol|
11991469|NCT00653003|Drug|Leflunomide|tablets, 20mg, single-dose
11991470|NCT00653003|Drug|ARAVA|Tablets, 20mg, single-dose
11991471|NCT00652977|Procedure|Ritgens maneuver|Delivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The maneuver was used during a uterine contraction
11991472|NCT00652977|Procedure|Standard care (Manual support of the perineum)|The protocol entailed our standard care: using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor.
11991473|NCT00652964|Device|CPAP|CPAP treatment for patients with congenital central hypoventilation syndrome
11991474|NCT00652951|Biological|GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)|Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination
11991475|NCT00652951|Biological|Infanrix™ hexa.|Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
11991476|NCT00652951|Biological|Pediacel™|Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
11991477|NCT00652951|Biological|Prevenar™|Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
11991478|NCT00652938|Biological|HPV Vaccine (GSK580299) Cervarix TM|IM administration
11991479|NCT00652938|Biological|Engerix B|IM administration
11991480|NCT00652925|Drug|Celecoxib|Higher dose, 6 mg/kg/dose BID
11991481|NCT00652925|Drug|Celecoxib|Active drug at lower dose
11991482|NCT00652925|Drug|Naproxen|Control comparator, 15 mg/kg/dy target dose
11991483|NCT00652912|Drug|Clonazepam|ODT, 1 mg
11991484|NCT00652912|Drug|Klonopin Wafers|ODT, 1 mg
11991485|NCT00652899|Biological|Allopurinol|All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion.
11991486|NCT00652899|Drug|Cyclophosphamide|60 mg/m^2 on Days 4 and 5 preceding natural killer cell infusion.
11991487|NCT00652899|Drug|Fludarabine phosphate|25 mg/m^2 on Days 6 through 2 preceding natural killer cell infusion.
11991489|NCT00652899|Biological|Allogeneic natural killer cells|Given day 0 - dose of 1.5-8.0 * 10^7/kg
11991490|NCT00652899|Biological|Aldesleukin|10 MU 3 times/week for a total of 6 doses beginning Day 0
11991491|NCT00652886|Drug|Oxandrolone|Tablets, 10mg, single-dose
11991492|NCT00652886|Drug|Oxandrin|tablets, 10mg, single-dose
11991493|NCT00652873|Drug|Cabergoline|Tablets 0.5 mg (2 x 0.5 mg dose), fed
11991494|NCT00652873|Drug|Dostinex|Tablets, 0.5 mg (2 X 0.5 mg dose), fed
11991495|NCT00652860|Biological|aerosol sargramostim|
11991496|NCT00652860|Biological|sargramostim|
11991497|NCT00652860|Drug|cisplatin|
11991498|NCT00652860|Drug|doxorubicin hydrochloride|
11991499|NCT00652860|Drug|ifosfamide|
11991500|NCT00652860|Drug|mitomycin C|
11991501|NCT00652860|Other|flow cytometry|
11991502|NCT00652860|Other|immunological diagnostic method|
11991503|NCT00652860|Other|laboratory biomarker analysis|
11991504|NCT00652860|Procedure|adjuvant therapy|
11991505|NCT00652860|Procedure|multimodality therapy|
11991506|NCT00652860|Procedure|neoadjuvant therapy|
11991507|NCT00652860|Procedure|therapeutic conventional surgery|
11991508|NCT00652860|Radiation|intraoperative radiation therapy|
11991509|NCT00652860|Radiation|selective external radiation therapy|
11991510|NCT00652847|Drug|ezetimibe|ezetimibe 10 mg/day for a six week course of treatment.
11991511|NCT00652847|Drug|statins|patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase
11991512|NCT00652834|Procedure|Small bowel capsule endoscopy (SBCE)|SBCE will be performed at Day 2 and Day 30.
11991513|NCT00652834|Drug|myfortic|switching from mycophenolate mofetil to mycophenolic acid on equimolar basis
11991514|NCT00652821|Drug|Tramadol/ APAP|Tablets 37.5mg /325mg
11991515|NCT00652821|Drug|Ultracet|Tablets, 37.5mg/325mg
11991516|NCT00652808|Drug|valdecoxib|valdecoxib 10 mg tablet by mouth once daily for 6 weeks
11991517|NCT00652808|Drug|naproxen|naproxen 500 mg capsule by mouth twice daily for 6 weeks
11991518|NCT00652795|Drug|Doxycycline Monohydrate|Tablets, 150 mg, single-dose
11991519|NCT00652795|Drug|Monodox|Capsules 50 mg (3 x 50 mg dose), single-dose
11991520|NCT00652782|Drug|rolofyline|rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
11991521|NCT00652782|Drug|Comparator Placebo (unspecified)|Matching placebo for rolofyline IV QD; 3 days
11991522|NCT00652769|Procedure|Endobronchial or Endoscopic Ultrasound|Patients with anterior mediastinal or subcarinal disease will undergo EBUS. Patients with posterior, subcarinal or AP window disease will undergo EUS. Patients with no mediastinal disease on CT scan will undergo EBUS.
11991523|NCT00652769|Procedure|Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy|Investigations will be determined by the multi-disciplinary team responsible for the patient
11991524|NCT00652756|Device|Use of ventilator during patient transport (Versamed iVent)|The goal of the transport ventilator is to provide optimal ventilation.
11991525|NCT00652756|Other|Bag-valve ventilation|Use of bag-valve ventilation during patient transport.
11991526|NCT00652743|Biological|Pandemic influenza vaccine GSK1562902A|IM administration
11991527|NCT00652730|Drug|Buspirone HCl|Tablets, 30 mg, single-dose, fasting conditions
11991528|NCT00652730|Drug|Buspirone HCl|Tablets, 30 mg, single-dose, fed conditions
11991529|NCT00652730|Drug|Buspar|Tablets, 30 mg, single-dose, fed conditions
11991530|NCT00652717|Drug|Ezetimibe|Ezetimibe 10 mg daily for 42 days.
11991531|NCT00652717|Drug|simvastatin|simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.
11991532|NCT00652704|Drug|Doxycycline monohydrate|Capsules, 100 mg, fed
11991533|NCT00652704|Drug|Monodox|Capsules, 100 mg, fed
11991534|NCT00652704|Drug|Doxycycline Monohydrate|Capsules, 100 mg, fasting
11991535|NCT00652691|Biological|filgrastim|
11991536|NCT00652691|Drug|carboplatin|
11991537|NCT00652691|Drug|cyclophosphamide|
11991538|NCT00652691|Drug|topotecan hydrochloride|
11991539|NCT00652691|Procedure|autologous hematopoietic stem cell transplantation|
11991540|NCT00652691|Procedure|peripheral blood stem cell transplantation|
11991541|NCT00652665|Drug|Leflunomide|Tablets, 20mg, single-dose
11991542|NCT00652665|Drug|ARAVA|Tablets, 20mg,single-dose
11991543|NCT00652652|Drug|nesiritide, furosemide|
11991544|NCT00652639|Drug|Clonazepam|Tablets, 1 mg, single-dose
11991545|NCT00652639|Drug|Klonopin|tablets, 1 mg, single-dose
11991546|NCT00652626|Drug|azacitidine|
11991547|NCT00652613|Radiation|3 Dimensional Radiation Therapy|Radiation with 6 MV photons to dose of 70Gy/ 35#/ 7 weeks
11991548|NCT00652613|Radiation|Intensity Modulated Radiation Therapy|IMRT with 6 MV photons to a dose of 66Gy/30#/ 6 weeks
11991549|NCT00652600|Drug|Propranolol|ER Capsules, 160 mg, single-dose
11991550|NCT00652600|Drug|Inderal-LA|ER Capsules, 160 mg, single-dose
11991551|NCT00652587|Procedure|hepatectomy and transcatheter arterial chemoembolization|partial hepatectomy with adjuvant transcatheter arterial chemoembolization
11991552|NCT00652587|Procedure|hepatectomy|hepatectomy alone
11991553|NCT00652574|Drug|Dasatinib|70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
11991554|NCT00652561|Drug|S-1|All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the second stage only if the stage 2 criteria are met, where 3/30 (10%) or more patients must have achieved a confirmed response (CR or PR) in stage 1.The study may go to the third stage only if at least 8/50 patients (16%) must have achieved a confirmed response in stage 2
11991555|NCT00652522|Device|ICD/CRT implant|Implantation of a ICD/ CRT device if not yet implanted
11991556|NCT00652522|Procedure|AF ablation|Atrial Fibrillation ablation by pulmonary vein isolation
11991557|NCT00652522|Other|Best Medical Treatment|Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.
11991722|NCT00651404|Drug|Ezetimibe|oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
11991558|NCT00652509|Behavioral|Interactive Dialogue to Educate and Activate (IDEA)|IDEA - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients.
11991559|NCT00652509|Behavioral|Individual Education (IE)|IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.
11991560|NCT00652496|Drug|Bimatoprost 0.01% ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
11991561|NCT00652496|Drug|Bimatoprost 0.015% formulation 1 ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
11991562|NCT00652496|Drug|Bimatoprost 0.015% formulation 2 ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
11991563|NCT00652496|Drug|Bimatoprost 0.02% ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
11991564|NCT00652496|Drug|Bimatoprost 0.03% ophthalmic solution|Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs
11991565|NCT00652483|Drug|Brimonidine ophthalmic solution 0.1%|1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
11991566|NCT00652483|Drug|Brimonidine ophthalmic solution 0.2%|1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
11991567|NCT00652470|Procedure|Endoscopic Third Ventriculostomy|A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.
11991568|NCT00652470|Procedure|CSF Shunt Insertion|The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.
11991569|NCT00652457|Drug|Memantine|10 mg BID x 3 months
11991570|NCT00652444|Drug|ezetimibe|ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
11991571|NCT00652444|Drug|simvastatin|simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
11991572|NCT00652444|Drug|Placebo (Unspecified)|Matching ezetimibe placebo
11991573|NCT00652431|Drug|Vytorin + Niaspan|Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days + Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
11991574|NCT00652431|Drug|Vytorin|Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days
11991575|NCT00652431|Drug|Niaspan|Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
11991576|NCT00652418|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)|Magnevist at a dose of 0.1 mmol/kg
11991577|NCT00652418|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)|Magnevist at a dose of 0.2 mmol/kg
11991578|NCT00652405|Dietary Supplement|alcohol|250 ml of white wine (13% vol; ~25 gram of alcohol per day)
11991579|NCT00652405|Dietary Supplement|Placebo|250 ml of mineral water (Brand name: Vittel)
11991580|NCT00652392|Drug|budesonide/formoterol|
11991581|NCT00652392|Drug|budesonide and placebo|
11991582|NCT00652379|Drug|Pegvisomant|Pegvisomant s.c 15-30 mg 2 times a week
11991583|NCT00652379|Drug|Somatostatin analog (lanreotide or octreotide)|Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
11991584|NCT00652366|Drug|Erlotinib, escalating dose|100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily
11991585|NCT00652366|Drug|Erlotinib, standard dose|100mg, PO, once daily
11991586|NCT00652366|Drug|Gemcitabine|1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle
11991587|NCT00652353|Other|44-55-66-PM|"The mnemonic 44-55-66-PM helps to remember the components of the Ottawa Ankle and foot Rule.
~44: Is to remember that an X-ray is required if the patients is unable to walk 4 steps at the moment of the Accident AND during the physical examination 55: Is to remember that an X-ray of the foot is required if the patient has pain at the basis of the 5Th metatarsal of at the 5caphoid 66-PM: Is to remember that an X-ray of the ankle is required if the patient has pain in the Posterior of the lateral or medial malleolar"
11991588|NCT00652353|Other|control|Participants will be instructed of the components of the Ottawa Ankle Rule on a standardized sheet
11991589|NCT00652340|Drug|apricoxib/erlotinib|"apricoxib: 100 mg tablets, 400mg/day
~erlotinib: per package insert"
11991590|NCT00652340|Drug|erlotinib/placebo|"erlotinib: per package insert
~placebo: 100 mg tablets, 400 mg/day"
11991591|NCT00652327|Drug|Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin)|ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks
11991592|NCT00652327|Drug|Double Statin (simvastatin, atorvastatin, or pravastatin)|simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks
11991593|NCT00652314|Device|Thrombi-Gel|Applicaton of Hemostatic product during surgery
11991594|NCT00652301|Drug|ezetimibe|ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
11991595|NCT00652301|Drug|Comparator: Placebo (unspecified)|matching placebo tablet. Duration of Treatment 31 Weeks.
11991596|NCT00652301|Drug|simvastatin|simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
11991597|NCT00652288|Drug|Insulin analogs (Lispro and Aspart)|Insulin bolus given through insulin pump
11991598|NCT00652288|Drug|Insulin analogs (Aspart and Detemir)|Drugs given separately
11991599|NCT00652288|Drug|Insulin analogs (Aspart and Detemir)|Drugs given in the same injection
11991600|NCT00652288|Drug|Insulin analogs (Lispro and Glargine)|Drugs given separately
11991601|NCT00652288|Drug|Insulin analogs (Lispro and Glargine)|Drugs given in single injection
11991602|NCT00652275|Biological|MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP|189 children will receive 3 doses of experimental vaccine
11991603|NCT00652275|Biological|Verorab vaccine|189 volunteers will receive Verorab vaccine, 0.5 Ml at day 0, 28 and 56.
11991604|NCT00652262|Drug|Levitra (Vardenafil, BAY38-9456)|Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.
11991605|NCT00652236|Other|Physiotherapy|The two groups passed an in-patient rehabilitation and a physiotherapy: FCT function-centred vs. PCT pain-centred
11991606|NCT00652223|Biological|CYT005-AllQbG10|Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT
11991607|NCT00652210|Other|Multiphoton microscopy|Use of multiphoton microscopy to diagnose cancer
11991608|NCT00652184|Drug|ARYS-01 (sorivudine) cream 3% or placebo cream|sorivudine cream 3% or placebo cream twice daily for 10 days
11991609|NCT00652184|Drug|placebo|placebo cream and placebo valaciclovir
11991610|NCT00652184|Drug|valaciclovir|active valaciclovir
11991611|NCT00652171|Drug|Lamotrigine|Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
11991612|NCT00652171|Dietary Supplement|Amide|Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
11991613|NCT00652158|Drug|MLN8054|"10 mg doses of MLN8054 were given orally once daily following a schedule of 5 days on/2 days off/5 days on repeated every 28 days"
11991614|NCT00652145|Drug|mesalamine|Increase dose by 2.4gm per day over baseline dose
11991615|NCT00652132|Drug|cisplatin|
11991616|NCT00652132|Drug|sodium thiosulfate|
11991617|NCT00652119|Drug|Paclitaxel|Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle.
11991618|NCT00652119|Drug|Carboplatin|Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle.
11991619|NCT00652119|Drug|Avastin|Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle.
11991620|NCT00652106|Drug|0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution|0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
11991621|NCT00652106|Drug|Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution|Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
11991622|NCT00652106|Drug|Brimonidine 0.2% ophthalmic solution|Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
11991623|NCT00652093|Drug|opana then darvocet then placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
11991624|NCT00652093|Drug|opana then placebo then darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
11991625|NCT00652093|Drug|placebo then opana then darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
11991626|NCT00652093|Drug|Placebo then darvocet then opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
11991627|NCT00652093|Drug|Darvocet then opana then placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
11991628|NCT00652093|Drug|Darvocet then placebo then opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
11991629|NCT00652080|Drug|API 31510|Topical Cream; 3% active; AM & PM application
11991630|NCT00652054|Drug|S-1|All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial will proceed to the second stage only if sufficient efficacy is demonstrated in Stage 1.
11991631|NCT00652041|Drug|Bortezomib|Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4
11991632|NCT00652041|Drug|Thalidomide|Thalidomide, day 1 cycle 1, 100 mg/24 h. oral, in combination with cyclophosphamide and dexamethasone. If toxicity is <Grade 2, dose should be increased to 200 mg/24 h. in day 15
11991633|NCT00652041|Drug|Bortezomib|Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1.
11991634|NCT00652028|Drug|Dexmedetomidine, midazolam; fentanyl|Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
11991635|NCT00652002|Drug|budesonide/formoterol|
11991636|NCT00652002|Drug|budesonide|
11991637|NCT00652002|Drug|formoterol|
11991638|NCT00651989|Other|optical coherence tomography foveal thickness measurement|In the same session in one randomly selected eye of each subject three consecutive measurements of foveal thickness were performed using both time-domain OCT and spectral-domain OCT.
11991639|NCT00651976|Drug|letrozole|Take by mouth at a dose of 2.5 mg on days 7-21
11991640|NCT00651976|Other|Blood Collection|Blood used for gene expression analysis and reverse transcriptase-polymerase chain reaction
11991641|NCT00651976|Procedure|biopsy/lumpectomy/mastectomy|Tissue collection,Surgery to remove tumor, Tumor tissues used for laboratory biomarker analysis
11991642|NCT00651963|Drug|ezetimibe|"Ezetimibe 10 mg daily was added during 4 weeks.
~The patients continued taking their usual Statin without titrating the dose."
11991643|NCT00651937|Drug|Melphalan|100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.
11991644|NCT00651937|Procedure|Stem Cell Infusion|"Stem Cell Infusion is Day 0.
~Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0
~High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0."
11991645|NCT00651937|Behavioral|Questionnaires|Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
11991646|NCT00651937|Drug|Granulocyte-colony stimulating factor (G-CSF)|5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.
11991647|NCT00651937|Procedure|Apheresis|Collection of stem cells from blood collected either through CVC or from a vein in one arm.
11991648|NCT00651924|Behavioral|IVR-based Cognitive-behavior therapy|Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
11991649|NCT00651911|Drug|urate oxidase|First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications.
11991650|NCT00651885|Drug|treprostinil dienthanolmine sustained release|UT-15C SR 1mg tablet
11991651|NCT00651885|Drug|Placebo|Placebo
11991652|NCT00651859|Drug|Bimatoprost 0.01% Ophthalmic Solution|Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
11991653|NCT00651859|Drug|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
11991654|NCT00651859|Drug|Bimatoprost Vehicle Ophthalmic Solution|Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
11991655|NCT00651846|Drug|Yasmin (DRSP 3mg/EE 0.03 mg)|The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (3mg DRSP/0.03 mgEE). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).
11991656|NCT00651846|Drug|Microgynon (LNG 0.15 mg/EE 0.03 mg)|The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (LNG 0.15 mg/EE 0.03 mg). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).
11991657|NCT00651833|Drug|S-1|All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the third stage only if 7/31 (23%) or more patients have achieved a confirmed response (CR or PR) in stages 1 and 2 combined.
11991658|NCT00651820|Drug|Collagenase Santyl|"Dermatome-induced skin wounds treated with drug active.
~Each subject serves as his own control receiving both treatments in parallel."
11991659|NCT00651820|Drug|Collagenase Santyl Vehicle|Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
11991660|NCT00651807|Drug|etonogestrel|Lowest dose of Org 3236 per two days, lowest dose of Org 3236 per day, highest dose of Org 3236 per day for 8 weeks
11991661|NCT00651807|Drug|Placebo|Every day one tablet up to 8 weeks
11991662|NCT00651794|Behavioral|Teamwork training|Crew Resource Management (CRM) is an aviation training program mandated for all crew members that teaches human factors concepts, communication skills, and teamwork behaviors that can prevent and manage error. Over the last six years the study team has translated these behaviors to neonatal resuscitation and demonstrated that they can be reliably measured. Adding teamwork instruction to the existing NRP, based upon CRM, may be a method to improve communication, teamwork, and the overall quality of neonatal resuscitation.
11991663|NCT00651794|Behavioral|Standard NRP curriculum|The existing NRP course, taught to most caregivers in the United States who care for newborns, focuses on teaching the technical aspects of neonatal resuscitation with little attention paid to communication and teamwork.
11991664|NCT00651794|Behavioral|Skills practice with low-fidelity mannequin|
11991665|NCT00651794|Behavioral|Skills practice with high-fidelity mannequin|SimBaby mannequins (Laerdal Medical Corp, Stavanger, Norway) were used in the high-fidelity skills stations. These mannequins have simulated heart tones, breath sounds, pulses, and cries.
11991666|NCT00651781|Drug|Bortezomib|2 times per week of Velcade administration.
11991667|NCT00651768|Drug|budesonide/formoterol|
11991668|NCT00651768|Drug|Symbicort pMDI + budesonide HFA pMDI|Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg
11991669|NCT00651755|Drug|Aprepitant|125 mg By Mouth (PO) On Day 1, followed by 80 mg PO Daily On Days 2-3.
11991670|NCT00651755|Drug|Cyclophosphamide|750 mg/m^2 By Vein On Day 1
11991671|NCT00651755|Drug|Doxorubicin|25 mg/m^2 By Vein Over 48 Hours On Days 1-2
11991672|NCT00651755|Drug|Vincristine|2 mg By Vein On Day 1
11991673|NCT00651755|Drug|Prednisone|100 mg PO for 5 Days
11991674|NCT00651755|Drug|Rituximab|375 mg/m^2 By Vein On Day 1.
11991675|NCT00651755|Drug|Ondansetron|8 mg daily for 2 days
11991676|NCT00651742|Drug|S-1|All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial will proceed to the second stage only if sufficient efficacy is demonstrated in Stage 1.
11991677|NCT00651729|Biological|Botulinum Toxin Type A|Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg
11991678|NCT00651716|Other|flow cytometry|Lymphocyte Analysis: Lymphocyte subset studies will be performed on samples obtained from the patient, donor, or graft. Aliquots will be analyzed using standard flow cytometry.
11991679|NCT00651716|Other|laboratory biomarker analysis|Identification of gut-homing and skin-homing Treg subsets
11991723|NCT00651404|Drug|Placebo|oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
11991724|NCT00651391|Drug|Ezetimibe + Simvastatin|oral tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily in the evening for 12 weeks
11991680|NCT00651716|Other|Data Collection|Patient samples will receive an alphanumeric code assigned by the principal investigator so that patient and donor identity will be known only to study investigators and research staff. Clinical records on each patient will be reviewed by participating investigators or research staff on a routine basis so that relevant clinical information including survival, malignancy relapse, and GVHD can be included in the patient database. Flow cytometry results will also be included in this database.
11991681|NCT00651703|Biological|CYT004-MelQbG10 + Montanide|
11991682|NCT00651703|Biological|CYT004-MelQbG10 + Montanide + Imiquimod|
11991683|NCT00651703|Biological|CYT004-MelQbG10 + Imiquimod|
11991684|NCT00651703|Biological|CYT004-MelQbG10 intra nodal injection|
11991685|NCT00651690|Biological|Botulinum Toxin Type A|200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18
11991686|NCT00651690|Biological|Placebo|Saline injection on Day 0
11991687|NCT00651677|Procedure|HAL proctectomy|Hand-assisted laparoscopic proctectomy
11991688|NCT00651677|Procedure|"straight laparoscopic proctectomy"|"straight laparoscopic proctectomy"
11991689|NCT00651677|Procedure|Hand-assisted laparoscopic proctectomy|hand-assisted laparoscopic proctectomy
11991690|NCT00651677|Procedure|SL Proctectomy|Straight laparoscopic proctectomy
11991691|NCT00651664|Drug|alisertib|Alisertib (MLN8237) capsules
11991692|NCT00651651|Drug|budesonide/formoterol|
11991693|NCT00651651|Drug|budesonide|
11991694|NCT00651651|Drug|formoterol|
11991695|NCT00651638|Drug|Treatment with ARQ 197|Treatment with ARQ 197
11991696|NCT00651625|Device|Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001|The RPD is a safety syringe device that is hypothesized to be safer, less painful, and more effective for patients undergoing a syringe and needle procedure (please see arm #1).
11991697|NCT00651625|Device|conventional syringe - BD Ref 309604|the conventional syringe or the RPD will be used for syringe and needle procedures performed by physicians.
11991698|NCT00651612|Drug|Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution|Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
11991699|NCT00651612|Drug|Concurrent brimonidine 0.2% and 0.5% timolol|Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)
11991700|NCT00651599|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
11991701|NCT00651599|Drug|Placebo|Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
11991702|NCT00651586|Drug|Gatifloxacin 0.3% ophthalmic solution|Gatifloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner
11991703|NCT00651586|Drug|Ciprofloxacin 0.3% ophthalmic solution|Ciprofloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner
11991704|NCT00651573|Procedure|Blood transfusion at hematocrit value less than 24%|transfusion
11991705|NCT00651573|Procedure|Blood transfusion at hematocrit value less than 28%|transfusion
11991706|NCT00651560|Drug|ezetimibe (+) simvastatin|ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.
11991707|NCT00651547|Drug|budesonide/formoterol|
11991708|NCT00651547|Drug|budesonide|
11991709|NCT00651547|Drug|formoterol|
11991710|NCT00651534|Drug|Ronacaleret|
11991711|NCT00651508|Drug|KOS-1584|25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.
11991712|NCT00651495|Behavioral|Patient decision aids for chronic conditions|Videos providing comprehensive information about chronic disease management
11991713|NCT00651482|Drug|Everolimus|
11991714|NCT00651482|Drug|Bevacizumab|
11991715|NCT00651469|Drug|YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)|The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
11991716|NCT00651469|Drug|Placebo|The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
11991717|NCT00651456|Drug|Standard Chemotherapy (Pemetrexed and Cisplatin)|"Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
~Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)"
11991718|NCT00651456|Drug|Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab|"Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
~Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)
~Bevacizumab 15 mg/kg D1 (D1=D22, until progression)"
11991719|NCT00651443|Drug|Galiximab|Galiximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen.
11991720|NCT00651417|Dietary Supplement|Organic Germanium|Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated
11991721|NCT00651417|Dietary Supplement|Placebo|Placebo tablets orally 3 - 5 times per day as tolerated
11991725|NCT00651391|Drug|Simvastatin|oral simvastatin 20 mg once daily in the evening for 12 weeks
11991726|NCT00651391|Drug|Placebo|oral placebo once daily in the evening for 12 weeks
11991727|NCT00651378|Drug|Rosuvastatin|oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
11991728|NCT00651378|Drug|Ezetimibe + Atorvastatin|oral tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily)
11991729|NCT00651378|Drug|Double Atorvastatin|oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)
11991730|NCT00651365|Drug|JNJ-38877605|
11991731|NCT00651352|Drug|4 mg nicotine lozenge|marketed formulation
11991732|NCT00651352|Drug|2 mg nicotine lozenge|marketed formulation
11991733|NCT00651352|Drug|2 mg nicotine prototype|2 mg
11991734|NCT00651352|Drug|4 mg nicotine prototype|4 mg
11991735|NCT00651339|Drug|botox|botox injection
11991736|NCT00651326|Drug|bicalutamide|
11991737|NCT00651326|Drug|buserelin|
11991738|NCT00651326|Drug|flutamide|
11991739|NCT00651326|Drug|goserelin|
11991740|NCT00651326|Drug|leuprolide acetate|
11991741|NCT00651326|Procedure|neoadjuvant therapy|
11991742|NCT00651326|Procedure|quality-of-life assessment|
11991743|NCT00651326|Radiation|radiation therapy|"46 Gy in 23 fractions over < 5 weeks.
~Boost:
~24-28 Gy in 12-14 fractions over < 3 weeks"
11991744|NCT00651326|Drug|Docetaxel|
11991745|NCT00651313|Drug|Lidocaine|Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
11991746|NCT00651313|Drug|Placebo|Placebo vaginal gel administered once daily for 4 days
11991747|NCT00651300|Drug|Parecoxib/Valdecoxib|A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
11991748|NCT00651300|Drug|Placebo|A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
11991749|NCT00651287|Drug|quinapril 20 mg|Quinapril 20 mg oral tablet daily for the first 6 weeks, and if a responder, continued on quinapril 20 mg for an additional 6 weeks
11991750|NCT00651287|Drug|quinapril 20 mg plus hydrochlorothiazide 12.5 mg|Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 20 mg plus hydrochlorothiazde 12.5 mg daily (Accuzide tablets) for 6 weeks
11991751|NCT00651287|Drug|quinapril 40 mg|Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 40 mg oral tablet daily for 6 weeks
11991752|NCT00651274|Drug|Ezetimibe|oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
11991753|NCT00651274|Drug|Placebo|oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
11991754|NCT00651261|Drug|cytarabine|Given IV
11991755|NCT00651261|Drug|daunorubicin|Given IV
11991756|NCT00651261|Drug|midostaurin|Given orally
11991757|NCT00651261|Other|placebo|Given orally
11991758|NCT00651261|Drug|dexamethasone acetate|ocular medication administration
11991759|NCT00651235|Drug|Losartan and Atenolol or Propranolol|"50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children.
~Losartan is 100 mg/day for adult and 50 mg/day for children."
11991760|NCT00651235|Drug|Atenolol or Propranolol|The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
11991761|NCT00651222|Other|No intervention was required|Death records were reviewed, therefore, there was no intervention
11991762|NCT00651209|Drug|Tenofovir|All patients receive 600 mg/day, oral telbivudine for 24 weeks. Patients with non-detectable HBV DNA continue 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 1) Patients with detectable HBV DNA receive 300 mg/day, oral tenofovir plus 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 2)
11991763|NCT00651183|Drug|Pramipexole immediate release|
11991764|NCT00651157|Biological|wild-type reovirus|Given IV: Administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle.
11991765|NCT00651144|Drug|Ezetimibe + Rosuvastatin|oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
11991766|NCT00651144|Drug|Rosuvastatin|oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
11991767|NCT00651144|Drug|Placebo|oral tablets; two ezetimibe placebo once daily for 14 days
11991768|NCT00651144|Drug|Ezetimibe|oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days
11991769|NCT00651131|Drug|daptomycin|daptomycin i.v. 4 mg/kg q24h for 7-14 days
11991770|NCT00651118|Drug|Placebo|placebo
11991771|NCT00651118|Drug|azelastine Hcl|azelastine Hcl 548 mcg
11991772|NCT00651118|Drug|azelastineHcl / fluticasone propionate|azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
11991773|NCT00651118|Drug|fluticasone propionate|fluticasone propionate 200 mcg
11991774|NCT00651105|Drug|Vildagliptin|
11991775|NCT00651105|Drug|Placebo|
11991776|NCT00651092|Procedure|bilateral nasal inferior turbinectomy|the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed
11991777|NCT00651092|Procedure|endoscopic submucosal resection of the inferior turbinates|surgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates
11991778|NCT00651079|Drug|GSK1247303|
11991779|NCT00651066|Drug|rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1|3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg TPW 3 wks switch to 150 mg OD 4 wks);
11991780|NCT00651066|Drug|rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2|3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg OD 3 wks switch to 150 mg TPW 4 wks);
11992166|NCT00648440|Drug|ProAmatine® Tablets 5 mg|5mg, single dose fed
11991781|NCT00651053|Device|EUS|Sensitivity and specificity of EUS will be compared with PFT as reference standard.
11991782|NCT00651040|Drug|Prednisone|Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms
11991783|NCT00651040|Drug|Methotrexate|MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
11991784|NCT00651027|Drug|PF-868554|200 mg, Child-Pugh Class A
11991785|NCT00651027|Drug|PF-868554|200 mg, Child-Pugh Class B
11991786|NCT00651027|Drug|PF-868554|200 mg, healthy volunteers
11991787|NCT00651014|Drug|Ezetimibe|oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
11991788|NCT00651014|Drug|Placebo|oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
11991789|NCT00650988|Procedure|Cryospray Ablation|Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact. Frozen state is defined as mucosa appearing white. Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray. This cycle is repeated 4 times in each area of treatment.
11991790|NCT00650975|Device|Laser Thromboablation|Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
11991791|NCT00650975|Device|PTCA (Direct Stenting)|Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
11991792|NCT00650962|Other|cardiopulmonary resuscitation|10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED
11991793|NCT00650962|Other|Rhythm analysis|Rhythm analysis as soon as AED is ready
11991794|NCT00650949|Drug|CYT997|Escalating doses (100mg/m^2 to 150mg/m^2), 24-hour intravenous infusion on Day 2 of a 21-day cycle (Phase Ib component). Dose selected in Phase Ib component to be used for Phase II component.
11991795|NCT00650949|Drug|Carboplatin|Intravenous infusion over 1 hour at area under the concentration-time curve (AUC)=5 on Day 1 of a 21-day cycle
11991796|NCT00650936|Device|AMPLATZER Septal Occluder|AMPLATZER Septal Occluder
11991797|NCT00650923|Drug|ziv-aflibercept|Given IV
11991798|NCT00650923|Procedure|radiation therapy|Undergo RT
11991799|NCT00650923|Drug|temozolomide|Given PO
11991800|NCT00650923|Procedure|pharmacological study|Correlative studies
11991801|NCT00650923|Procedure|laboratory biomarker analysis|Correlative studies
11991802|NCT00650910|Drug|lapatinib|1500 mg oral lapatinib starting Day 2 continuing through Day 9. Part 2 subjects received 1500mg daily through week 10.
11991803|NCT00650910|Drug|Digoxin|0.5mg on Days 1 and 9
11991804|NCT00650897|Drug|Escitalopram|10-20 mg once daily
11991805|NCT00650884|Device|Ankle Dorsiflexion Dynasplint System|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.
11991806|NCT00650871|Drug|GW679769|
11991807|NCT00650871|Drug|Placebo|
11991808|NCT00650858|Drug|tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)|0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
11991809|NCT00650845|Drug|Dotarem®-enhanced MRI|Single IV administration before MRI exam
11991810|NCT00650845|Other|non-enhanced MRI|non injected MRI
11991811|NCT00650832|Drug|TMC114; darunavir; Prezista|
11991812|NCT00650819|Drug|Ezetimibe + Simvastatin|ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks
11991813|NCT00650819|Drug|Simvastatin|simvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks
11991814|NCT00650819|Drug|Ezetimibe|Ezetimibe 10 mg plus simvastatin placebo once daily for 8 weeks
11991815|NCT00650806|Drug|Canagliflozin (JNJ-28431754)|One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
11991816|NCT00650806|Drug|Placebo|One matching placebo capsule orally once daily for 12 weeks.
11991817|NCT00650793|Drug|Extended Release OROS® Paliperidone|
11991818|NCT00650767|Drug|ARRY-438162, MEK inhibitor; oral|multiple dose, single schedule
11991819|NCT00650767|Drug|Placebo; oral|matching placebo
11991820|NCT00650754|Dietary Supplement|Dehydroepiandrosterone|25 mg PO TID
11991821|NCT00650754|Other|Placebo|Placebo
11991822|NCT00650728|Procedure|placing gastric tube|
11991823|NCT00650715|Device|Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands|Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. The Whole-body vibration intensity was kept constant at 30 Hz of frequency and 2 mm of amplitude.
11991824|NCT00650715|Device|Placebo Whole-body vibration exercise|Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. All exercises were performed without the influence of a vibratory stimulus.
11991825|NCT00650702|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
11991826|NCT00650702|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
11991827|NCT00650702|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy
11991828|NCT00650689|Drug|Ezetimibe + Atorvastatin|oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
11991829|NCT00650689|Drug|Atorvastatin|oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
11991830|NCT00650663|Drug|Ezetimibe + Simvastatin|oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks
11991831|NCT00650663|Drug|Simvastatin|oral tablet; simvastatin 20 mg once daily for 12 weeks
11991871|NCT00650416|Drug|Coreg® Tablets 12.5 mg|12.5mg, single dose fasting
11991832|NCT00650637|Drug|Calcium Carbonate|Calcium carbonate 500 mg oral tablet twice a day; given in combination with the following antiretroviral combination: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; All study drugs continued through to Week 12
11991833|NCT00650637|Drug|nelfinavir|1250 mg twice a day
11991834|NCT00650637|Drug|lamivudine|lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
11991835|NCT00650637|Drug|loperamide|If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;
11991836|NCT00650637|Other|Calcium carbonate not administered|Prophylaxis with calcium carbonate not administered in this group; The following antiretroviral combination was administered: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
11991837|NCT00650637|Drug|nelfinavir|nelfinavir 1250 mg twice a day
11991838|NCT00650637|Drug|lamivudine + zidovudine|lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
11991839|NCT00650624|Drug|valdecoxib|valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
11991840|NCT00650624|Drug|valdecoxib|valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
11991841|NCT00650624|Drug|valdecoxib|valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
11991842|NCT00650624|Drug|placebo|placebo tablet by mouth once daily in the morning for 6 weeks
11991843|NCT00650611|Drug|Ziprasidone|"Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10.
~Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1."
11991844|NCT00650611|Drug|Ziprasidone|"Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10.
~Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1."
11991845|NCT00650598|Drug|valdecoxib|valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6
11991846|NCT00650598|Drug|diclofenac|diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
11991847|NCT00650585|Behavioral|Project ALERT|Project ALERT (Adolescent Learning Experiences in Resistance Training) is a drug prevention curriculum designed for middle-school students (11 to 14 years old). The 11 lessons in the first year and 3 booster lessons in the second year focus on alcohol, tobacco, marijuana, and inhalants - the substances that adolescents are most likely to use. Project ALERT uses participatory activities and videos to help motivate youth to avoid drug use, to teach youth skills and strategies to resist peer pressures to use drugs, and to establish social norms against drug-use. More information about Project ALERT may be found at http://www.projectalert.best.org/.
11991848|NCT00650572|Drug|ARRY-380, HER2 inhibitor; oral|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
11991849|NCT00650559|Procedure|Chest wall enlargement|Widening sternotomy
11991850|NCT00650546|Drug|Exenatide|5 mcg twice a day titrated to 10 mcg twice a day
11991851|NCT00650533|Drug|Glimepiride Tablets 1 mg|1mg, single dose fed
11991852|NCT00650533|Drug|Amaryl® Tablets 1 mg|1mg, single dose fed
11991853|NCT00650520|Drug|BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg|4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
11991854|NCT00650520|Drug|Parlodel® (bromocriptine mesylate) capsules, USP 5 mg|4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
11991855|NCT00650507|Procedure|Remote ischemic preconditioning (RIPC)|The RIPC stimulus will be delivered in the OR prep room after the induction of anesthesia (while the anesthesiologist and staff are inserting vascular cannulae and preparing the patient for surgery). Whenever possible, the left lower limb will be selected for delivery of the stimulus. An appropriate sized cuff will be selected and connected to a hand aneroid sphygmomanometer. A second cuff and hand aneroid sphygmomanometer will be placed beside the one connected to the study subject. The cuff on the limb will be inflated and deflated to provide a total of four cycles of limb ischemia and reperfusion.
11991856|NCT00650507|Procedure|SHAM|For this group, the procedure will be identical for that described for the RIPC stimulus, with the exception that the blood pressure cuff placed on the subject will not be inflated, but the second cuff, that has been placed beside, will be inflated.
11991857|NCT00650494|Drug|Valacyclovir Hydrochloride Tablets 1000mg|1000mg, single dose fed
11991858|NCT00650494|Drug|Valtrex® 1000 mg|1000mg, single dose fed
11991859|NCT00650481|Drug|Oxybutynin Chloride Extended-release Tablets 5 mg|4x5mg, single dose fasting
11991860|NCT00650481|Drug|Ditropan XL® Tablets 5 mg|4x5mg, single dose fasting
11991861|NCT00650468|Drug|tacrolimus|Oral
11991862|NCT00650468|Drug|CellCept|IV or Oral
11991863|NCT00650468|Drug|steroids (methylprednisone or prednisone)|IV or Oral
11991864|NCT00650455|Drug|valdecoxib|valdecoxib 10 mg tablet once daily for 12 weeks
11991865|NCT00650455|Drug|naproxen|naproxen 500 mg capsule twice daily for 12 weeks
11991866|NCT00650455|Drug|placebo|placebo tablet every morning and capsule every evening for 12 weeks
11991867|NCT00650442|Drug|Estradiol Transdermal System Placebo - Alternate Adhesive|single application
11991868|NCT00650442|Drug|Estradiol Transdermal System Placebo - Current Adhesive|single application
11991869|NCT00650429|Drug|Ziprasidone|IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.
11991870|NCT00650416|Drug|Carvedilol Tablets 12.5 mg|12.5mg, single dose fasting
11991872|NCT00650403|Drug|Paroxetine hydrochloride 40 mg tablet|40mg, single dose fed
11991873|NCT00650403|Drug|Paxil® 40 mg Tablet|40mg, single dose fed
11991874|NCT00650390|Biological|adalimumab|40 mg adalimumab every other week
11991875|NCT00650377|Drug|Finasteride Tablets 5 mg|5mg, single dose fed
11991876|NCT00650377|Drug|Proscar® Tablets 5 mg|5mg, single dose fed
11991877|NCT00650364|Drug|Midodrine HCl Tablets 5 mg|5mg, single dose fasting
11991878|NCT00650364|Drug|ProAmatine® Tablets 5 mg|5mg, single dose fasting
11991879|NCT00650351|Drug|Ciprofloxacin Extended-Release Tablets 1000 mg|1000mg, single dose fed
11991880|NCT00650351|Drug|Cipro® XR Tablets 1000 mg|1000mg, single dose fed
11991881|NCT00650338|Drug|DE-104 ophthalmic solution, low concentration|Topical ocular application
11991882|NCT00650338|Drug|DE-104 ophthalmic solution, medium concentration|Topical ocular application
11991883|NCT00650338|Drug|DE-104 ophthalmic solution, high concentration|Topical ocular application
11991884|NCT00650338|Drug|Placebo|placebo
11991885|NCT00650338|Drug|0.005% latanoprost|Topical ocular application
11991886|NCT00650325|Drug|Sertraline Hydrochloride Tablets 100 mg|100mg, single dose fasting
11991887|NCT00650325|Drug|Zoloft® Tablets 100 mg|100mg, single dose fasting
11991888|NCT00650312|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fasting
11991889|NCT00650312|Drug|Glucophage® XR Tablets 500 mg|500mg, single dose fasting
11991890|NCT00650299|Drug|Alprazolam Extended-release Tablets 3 mg|3mg, single dose fed
11991891|NCT00650299|Drug|Xanax XR® Tablets 3 mg|3mg, single dose fed
11991892|NCT00650286|Drug|Modafinil Tablets 200 mg|200mg, single dose fed
11991893|NCT00650286|Drug|Provigil® Tablets 200 mg|200mg, single dose fed
11991894|NCT00650273|Drug|Azithromycin Tablets 600 mg|600mg, single dose fasting
11991895|NCT00650273|Drug|Zithromax® Tablets 600 mg|600mg, single dose fasting
11991896|NCT00650260|Device|Dynatherm Medical vitalHEAT Temperature Management System vH2|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical.
11991897|NCT00650260|Device|Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)|The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket.
11991898|NCT00650247|Drug|Sumatriptan Succinate Tablets 100 mg|100mg, single dose fed
11991899|NCT00650247|Drug|Imitrex® Tablets 100 mg|100mg, single dose fed
11991900|NCT00650234|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fasting
11991901|NCT00650234|Drug|Glucophage® XR Tablets 500 mg|500mg, single dose fasting
11991902|NCT00650221|Drug|Pravastatin|Single-dose 80 mg immediate-release oral tablet
11991903|NCT00650221|Drug|Pravastatin|Single-dose 80 mg immediate-release tablet
11991904|NCT00650208|Drug|Lamotrigine Tablets 25 mg|2x25mg, single dose fasting
11991905|NCT00650208|Drug|Lamictal® Tablets 25 mg|2x25mg, single dose fasting
11991906|NCT00650195|Drug|Metolazone Tablets 10 mg|10mg, single dose fasting
11991907|NCT00650195|Drug|Zaroloxyn® Tablets 10 mg|10mg, single dose fasting
11991908|NCT00650182|Drug|fentanyl; naltrexone|
11991909|NCT00650169|Drug|Clopidogrel Bisulfate Tablets 75 mg|75mg, single dose fed
11991910|NCT00650169|Drug|Plavix® Tablets 75 mg|75mg, single dose fed
11991911|NCT00650156|Biological|adalimumab|40 mg single sc dose
11991912|NCT00650156|Biological|adalimumab|80 mg single sc dose
11991913|NCT00650143|Drug|Lenograstim (GRANOCYTE)=GCSF|10 µg/kg/d s.c. for 5 days divided in two dosages per day
11991914|NCT00650143|Drug|Sitagliptin (Januvia)|100 mg p.o. per day for 28 days
11991915|NCT00650143|Drug|Sodium Chloride (NaCl) 0.9 %|applied s.c. twice a day for 5 days
11991916|NCT00650143|Drug|Gelatin|One capsule p.o. per day for 28 days
11991917|NCT00650117|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)|single application
11991918|NCT00650117|Drug|Duragesic 25 mcg/h + Scotch Duct Tape (3M)|single application
11991919|NCT00650117|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)|single application
11991920|NCT00650117|Drug|Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)|single application
11991921|NCT00650117|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)|single application
11991922|NCT00650117|Drug|Duragesic 25 mcg/h + Microfoam Tape (3M)|single application
11991923|NCT00650104|Drug|Ropinirole XL (formerly CR)|Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.
11991924|NCT00650091|Drug|N-acetylcysteine (NAC)|Participants will receive 600 mg of NAC three times a day.
11991925|NCT00650091|Drug|Placebo|Participants will receive placebo each day.
11991926|NCT00650078|Drug|MR prednisone|1 x 5 mg daily
11991927|NCT00650078|Drug|Placebo|1x daily
11991928|NCT00650065|Drug|Cetirizine HCl Tablets 10 mg|10mg, single dose fasting
11991929|NCT00650065|Drug|Zyrtec® Tablets 10 mg|10mg, single dose fasting
11991930|NCT00650052|Drug|Zonisamide Capsules 100 mg|100mg, single dose fasting
11991931|NCT00650052|Drug|Zonegran® Capsules 100 mg|100mg, single dose fasting
11991932|NCT00650039|Drug|placebo|valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.
11991933|NCT00650039|Drug|valdecoxib|valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.
11991934|NCT00650039|Drug|valdecoxib|valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
11991935|NCT00650026|Biological|adalimumab|40 mg adalimumab every other week
11991936|NCT00650013|Drug|Midodrine HCl Tablets 5 mg|5mg, single dose fed
11991937|NCT00650013|Drug|ProAmatine® Tablets 5 mg|5mg, single dose fed
11991938|NCT00650000|Drug|Modafinil Tablets 200 mg|200mg, single dose fasting
11991939|NCT00650000|Drug|Provigil® Tablets 200 mg|200mg, single dose fasting
11991940|NCT00649987|Drug|Albuterol Sulfate Extended-Release Tablets 8 mg|8mg, single dose fed
11991941|NCT00649987|Drug|VoSpire® ER Tablets 8 mg|8mg, single dose fed
11991942|NCT00649974|Drug|Valacyclovir Hydrochloride Tablets 1000 mg|1000mg, single dose fasting
11991943|NCT00649974|Drug|Valtrex® Tablets 1000 mg|1000mg, single dose fasting
11991944|NCT00649961|Drug|Melatonin injection|"A single intravenous infusion of melatonin will be given to each infant over 6 hours so that successive groups will receive increasing doses until the correct dose for age is found.
~Based on the pharmacokinetics and clearance of melatonin in adults an approximate dose has been calculated. The starting dose of melatonin will be 0.1 microgram/kg/hr to be given over 6 hours intravenously. The range of expected dose is 0.1-0.5 microgram/kg/hr."
11991945|NCT00649948|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fed
11991946|NCT00649948|Drug|Glucophage XR 500 mg|500mg, single dose fed
11991947|NCT00649935|Drug|Azithromycin Tablets 600 mg|600mg, single dose fed
11991948|NCT00649935|Drug|Zithromax® Tablets 600 mg|600mg, single dose fed
11991949|NCT00649922|Biological|adalimumab|80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
11991950|NCT00649922|Biological|placebo|2 injections Day 1, 1 injection Days 15 and 29
11991951|NCT00649922|Biological|adalimumab|40 mg adalimumab every other week
11991952|NCT00649896|Drug|Mylan Estradiol Transdermal System 0.025 mg/day|
11991953|NCT00649896|Drug|Climara® Transdermal System 0.025 mg/day|
11991954|NCT00649883|Biological|Influenza Trivalent Inactivated vaccines Novartis|Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
11991955|NCT00649883|Biological|Influenza Trivalent Inactivated vaccines|Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
11991956|NCT00649870|Drug|Valacyclovir Hydrochloride Tablets 1000 mg|1000mg, single dose fed
11991957|NCT00649870|Drug|Valtrex® Tablets 1000 mg|1000mg, single dose fed
11991958|NCT00649857|Drug|Cetirizine HCl Tablets 10 mg|10mg, single dose fed
11991959|NCT00649857|Drug|Zyrtec® 10 mg|10mg, single dose fed
11991960|NCT00649844|Drug|Clozapine|Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks
11991961|NCT00649844|Drug|Ziprasidone|Ziprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks
11991962|NCT00649831|Drug|Amoxicillin/clavulinic acid|amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
11991963|NCT00649831|Drug|Azithromycin|Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
11991964|NCT00649818|Drug|Lorazepam Tablets 2 mg|2mg, single dose fasting
11991965|NCT00649818|Drug|Ativan Tablets 2 mg|2mg, single dose fasting
11991966|NCT00649805|Drug|Verapamil Hydrochloride Extended-Release Capsules, 300 mg|300mg, single dose applesauce
11991967|NCT00649805|Drug|Verelan® PM Extended-Release Capsules, 300 mg|300mg, single dose applesauce
11991968|NCT00649792|Drug|Fampridine-SR|Tablets, 10 mg, BID (twice daily)
11991969|NCT00649779|Drug|albuterol sulfate extended-release 8 mg tablets|8mg, single dose fasting
11991970|NCT00649779|Drug|VoSpire™ ER 8 mg tablets|8mg, single dose fasting
11991971|NCT00649766|Behavioral|tailored newsletter|Tailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease
11991972|NCT00649766|Behavioral|targeted newsletter|Targeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans.
11991973|NCT00649753|Procedure|Category II Pelvic Blocking|Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction.
11991974|NCT00649753|Procedure|Category II Pelvic Blocking and Cranial|Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction. During pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts.
11991975|NCT00649753|Procedure|Cranial Only|Without pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts.
11991976|NCT00649740|Drug|Topiramate Sprinkle Capsules 25 mg|25mg, single dose fasting
11991977|NCT00649740|Drug|Topamax® Sprinkle Capsule 25 mg|25mg, single dose fasting
11991978|NCT00649727|Drug|Oxybutynin Chloride ER Tablets 10 mg|2x10mg, single dose fed
11991979|NCT00649727|Drug|Ditropan XL® Tablets 10 mg|2x10mg, single dose fed
11991980|NCT00649714|Drug|Zonisamide Capsules 100 mg|100mg, single dose fed
11991982|NCT00649701|Behavioral|Standard Text-Based Prevention Web Page|A link to the CDC.gov web page which describes HIV prevention among men who have sex with men.
11991983|NCT00649701|Behavioral|The Morning After|A dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use.
11991984|NCT00649701|Behavioral|Talking About HIV|A documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use.
11991985|NCT00649701|Behavioral|Both Videos|Morning After and Talking About HIV videos
11991986|NCT00649688|Drug|Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg|100/50mg, single dose fasting
11991987|NCT00649688|Drug|Lopressor HCT® Tablets 100/50 mg|100/50mg, single dose fasting
11991988|NCT00649675|Drug|Meloxicam Tablets 15 mg|15mg, single dose fed
11991989|NCT00649675|Drug|Mobic® Tablets 15 mg|15mg, single dose fed
11991990|NCT00649662|Drug|Ciprofloxacin Extended-Release Tablets 1000 mg|1000mg, single dose fasting
11991991|NCT00649662|Drug|Cipro® XR Tablets 1000 mg|1000mg, single dose fasting
11991992|NCT00649649|Drug|Quinapril Hydrochloride Tablets 40 mg|40mg, single dose fed
11991993|NCT00649649|Drug|Accupril® Tablets 40 mg|40mg, single dose fed
11991994|NCT00649636|Drug|Fluoxetine Capsules 40 mg|40mg, single dose fasting
11991995|NCT00649636|Drug|Prozac Pulvules 40 mg|40mg, single dose fasting
11991996|NCT00649623|Drug|Olmesartan Medoxomil Tablets 40 mg|40mg, single dose fasting
11991997|NCT00649623|Drug|Benicar® Tablets 40 mg|40mg, single dose fasting
11991998|NCT00649610|Drug|valdecoxib|valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
11991999|NCT00649610|Drug|diclofenac|diclofenac 75 mg twice daily (BID) for 7 days
11992000|NCT00649597|Drug|Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fasting
11992001|NCT00649597|Drug|Lotensin HCT® Tablets 20 mg/25 mg|20/25mg, single dose fasting
11992002|NCT00649584|Drug|SGN-35|IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
11992003|NCT00649584|Drug|gemcitabine|IV; 1000 mg/m2 weekly 3 out of 4 weeks
11992004|NCT00649571|Drug|Doxycycline Monohydrate Tablets (100 mg|100mg, single dose fasting
11992005|NCT00649571|Drug|Adoxa Tablets 100 mg|100mg, single dose fasting
11992006|NCT00649558|Drug|Pioglitazone HCl Tablets 45 mg|45mg, single dose fasting
11992007|NCT00649558|Drug|Actos® Tablets 45 mg|45mg, single dose fasting
11992008|NCT00649545|Biological|adalimumab|40 mg every other week
11992009|NCT00649532|Drug|Ondansetron Tablets 24 mg|24mg, single dose fasting
11992010|NCT00649532|Drug|Zofran® Tablets 24 mg|24mg, single dose fasting
11992011|NCT00649519|Drug|Amlodipine and Benazepril HCl Capsules 10 mg/20 mg|10/20mg, single dose fasting
11992012|NCT00649519|Drug|Lotrel® Capsules 10 mg/20 mg|10/20mg, single dose fasting
11992013|NCT00649506|Drug|Nitrofurantoin Macrocrystals 100 mg Capsules|100mg, single dose fed
11992014|NCT00649506|Drug|Macrodantin® 100 mg Capsules|100mg, single dose fed
11992015|NCT00649493|Drug|Rabeprazole Sodium Tablets 20 mg|20mg, single dose fed
11992016|NCT00649493|Drug|Aciphex® Tablets 20 mg|20mg, single dose fed
11992017|NCT00649480|Drug|BALSALAZIDE DISODIUM CAPSULES, 750 MG|3x750mg, single dose fed
11992018|NCT00649480|Drug|COLAZAL® Capsules 750 mg|3x750mg, single dose fed
11992019|NCT00649467|Drug|Topiramate Sprinkle Capsules 25 mg|25mg, single dose applesauce
11992020|NCT00649467|Drug|Topamax® Sprinkle Capsules 25 mg|25mg, single dose applesauce
11992021|NCT00649454|Drug|Glipizide and Metformin HCl Tablets 5 mg/500 mg|5/500mg, single dose fasting
11992022|NCT00649454|Drug|Metaglip® Tablets 5 mg/500 mg|5/500mg, single dose fasting
11992023|NCT00649441|Drug|Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fasting
11992024|NCT00649441|Drug|Accuretic™ Tablets 20 mg/25 mg|20/25mg, single dose fasting
11992025|NCT00649428|Biological|Autologous Human Fibroblast (azficel-T)|"Collection of 3 mm post auricular skin punch biopsies.
~Three injection treatments administered 5 ± 1 weeks apart on each side of the face."
11992026|NCT00649428|Biological|Placebo|"Collection of 3 mm post auricular skin punch biopsies.
~Three injection visits administered 5 ± 1 weeks apart on each side of the face."
11992027|NCT00649415|Drug|piroxicam|piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
11992028|NCT00649415|Drug|valdecoxib|valdecoxib 40 mg capsule twice a day (BID), taken as required, on the first day of treatment in the menstrual cycle followed by oral valdecoxib 40 mg once a day (QD) for up to the first 3 days of the menstural cycle
11992029|NCT00649402|Drug|Amlodipine and Benazepril HCl Capsules 10 mg/20 mg|10/120mg, single dose fed
11992030|NCT00649402|Drug|Lotrel® Capsules 10 mg/20 mg|10/20mg, single dose fed
11992031|NCT00649389|Drug|Olmesartan medoxomil|40mg olmesartan medoxomil
11992032|NCT00649389|Drug|Amlodipine|Amlodipine 10mg
11992033|NCT00649389|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25mg
11992034|NCT00649376|Drug|Fexofenadine Tablets 180 mg|180mg, single dose fasting
11992035|NCT00649376|Drug|Allegra® Tablets 180 mg|180mg, single dose fasting
11992036|NCT00649363|Drug|Ondansetron Orally Disintegrating Tablets 8 mg|8mg, single dose fasting
11992037|NCT00649363|Drug|Zofran ODT® Tablets 8 mg|8mg, single dose fasting
11992038|NCT00649350|Drug|Metformin Hydrochloride ER Tablets 750 mg|750mg, single dose fed
11992039|NCT00649350|Drug|Glucophage XR 750 mg|750mg, single dose fed
11992090|NCT00648973|Drug|Pseudoephedrine 120 mg|"Three times daily: two diphenhydramine-matching placebo capsules
~Twice daily: one pseudoephedrine 120 mg tablet"
11992091|NCT00648960|Drug|Clarithromycin|Single-dose 500 mg immediate-release oral tablet
11992092|NCT00648960|Drug|Clarithromycin|Single-dose 500 mg immediate-release oral dose
11992093|NCT00648947|Drug|Clopidogrel Bisulfate Tablets 75 mg|75mg, single dose fasting
11992094|NCT00648947|Drug|Plavix® Tablets 75 mg|75mg, single dose fasting
11992095|NCT00648934|Drug|Topiramate Sprinkle Capsules 25 mg|25mg, single dose fed
11992096|NCT00648934|Drug|Topamax® Sprinkle Capsules 25 mg|25mg, single dose fed
11992097|NCT00648921|Drug|Olanzapine Tablets 5 mg|5mg, single dose fasting
11992040|NCT00649337|Procedure|Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography|"AWBU is a computer-based system for performing and recording ultrasound scans of the whole breast. The transducer of any suitable high-resolution compound ultrasound equipment is attached to a mechanical arm guided by computer, and images are acquired in longitudinal rows, overlapping to assure complete coverage. The mechanical arm controls transducer speed and position, with a technician maintaining appropriate contact pressure and orientation vertical to the skin. Approximately 150-300 images per row are immediately displayed on the AWBU monitor, then permanently stored.
~The AWBU software creates a continuous ciné loop of the images, creating the appearance of real-time scanning. With spatial registration, any point on an image can be identified as a distance from the nipple in a specific radius. Image review is optimized by playback on a high-resolution monitor to allow compressed image size, 3-D reconstruction, and adjustment of contrast, brightness and review speed."
11992041|NCT00649324|Drug|Hydrochlorothiazide Tablets 50 mg|50mg, single dose fasting
11992042|NCT00649324|Drug|Hydrochlorothiazide Tablets (50 mg|50mg, single dose fasting
11992043|NCT00649311|Drug|eplerenone|Eplerenone 50 mg oral film-coated tablet once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to eplerenone 100 mg oral film-coated tablet once daily for 4 weeks.
11992044|NCT00649311|Drug|Losartan|Losartan 50 mg oral capsule once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to losartan 100 mg oral capsule once daily for 4 weeks
11992045|NCT00649298|Procedure|haemodialysis|Comparison of different weekly duration of haemodialysis treatment
11992046|NCT00649285|Drug|Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg|100mg, single dose fed
11992047|NCT00649285|Drug|Macrobid® Capsules 100 mg|100mg, single dose fed
11992048|NCT00649272|Drug|Oxybutynin Chloride Extended-Release Tablets, 15 mg|15mg, single dose fasting
11992049|NCT00649272|Drug|Ditropan XL® Extended-release tablets, 15 mg|15mg, single dose fasting
11992050|NCT00649259|Drug|Oxybutynin Chloride ER Tablets 10 mg|2x10mg, single dose fed
11992051|NCT00649259|Drug|Ditropan XL® Tablets 10 mg|2x10mg, single dose fed
11992052|NCT00649233|Drug|Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg|100/50mg, single dose fed
11992053|NCT00649233|Drug|Lopressor HCT® Tablets 100/50 mg|100/50mg, single dose fed
11992054|NCT00649220|Drug|Memantine|memantine tablets, twice a day (bid), for 20 weeks
11992055|NCT00649207|Drug|ABT-888|Oral Capsules
11992056|NCT00649207|Radiation|Whole Brain Radiation Therapy|15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
11992057|NCT00649194|Drug|Rabeprazole Sodium Delayed-Release Tablets 20 mg|20mg, single dose fed
11992058|NCT00649194|Drug|Aciphex® Tablets 20 mg|20mg, single dose fed
11992059|NCT00649181|Drug|Metolazone Tablets 5 mg|2x5mg, single dose fasting
11992060|NCT00649181|Drug|Zaroloxyn® Tablets 5 mg|2x5mg, single dose fasting
11992061|NCT00649168|Drug|BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg|2x5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
11992062|NCT00649168|Drug|Parlodel® (bromocriptine mesylate) capsules, USP 5 mg|2x5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
11992063|NCT00649155|Drug|Ciprofloxacin Extended-Release Tablets 500 mg|500mg, single dose fasting
11992064|NCT00649155|Drug|Cipro® XR Tablets (500 mg|500mg, single dose fasting
11992065|NCT00649142|Procedure|Open sutured mesh repair|Open sutured mesh repair
11992066|NCT00649142|Procedure|Laparoscopic mesh glue fixation|Laparoscopic mesh glue fixation
11992067|NCT00649129|Drug|Oxybutynin Chloride ER Tablets 10 mg|2x10mg, single dose fasting
11992068|NCT00649129|Drug|Ditropan XL® Tablets 10 mg|2x10mg, single dose fasting
11992069|NCT00649116|Drug|Metoprolol Tartrate Tablets 100 mg|100mg, single dose fed
11992070|NCT00649116|Drug|Lopressor® Tablets 100 mg|100mg, single dose fed
11992071|NCT00649103|Drug|Quinapril Hydrochloride Tablets 40 mg|40mg, single dose fasting
11992072|NCT00649103|Drug|Accupril® Tablets 40 mg|40mg, single dose fasting
11992073|NCT00649090|Drug|exemestane|Exemestane 25 mg oral tablet once daily for a maximum of 3 years
11992074|NCT00649077|Drug|Meloxicam Tablets 15 mg|15mg, single dose fasting
11992075|NCT00649077|Drug|Mobic® Tablets 15 mg|15mg, single dose fasting
11992076|NCT00649064|Drug|Ziprasidone|Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
11992077|NCT00649051|Drug|Metolazone Tablets 2.5 mg|4x2.5mg, single dose fasting
11992078|NCT00649051|Drug|Zaroloxyn® Tablets 2.5 mg|4x2.5mg, single dose fasting
11992079|NCT00649038|Drug|Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fed
11992080|NCT00649038|Drug|Lotensin HCT® Tablets 20 mg/25 mg|20/25mg, single dose fed
11992081|NCT00649025|Drug|FlutiForm 250/10|SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
11992082|NCT00649025|Drug|SKP-Fluticasone|SKP Fluticasone 250 ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
11992083|NCT00649025|Drug|Flovent Fluticasone HFA|Flovent 250 ug HFA is a pMDI that delivers after priming 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
11992084|NCT00649012|Drug|Pioglitazone HCl Tablets 45 mg|45mg, single dose fed
11992085|NCT00649012|Drug|Actos® Tablets 45 mg|45mg, single dose fed
11992086|NCT00648999|Drug|lopinavir/ritonavir|lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
11992087|NCT00648986|Drug|Tazorac|All patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks.
11992088|NCT00648973|Drug|Diphenhydramine 50 mg|"Three times daily: two diphenhydramine 25 mg capsules
~Twice daily: one pseudoephedrine-matching placebo tablet"
11992089|NCT00648973|Drug|Diphenhydramine 25 mg|"Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule
~Twice daily: one pseudoephedrine-matching placebo tablet"
11992098|NCT00648921|Drug|Zyprexa® Tablets 5 mg|5mg, single dose fasting
11992100|NCT00648895|Drug|Nebivolol|nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
11992101|NCT00648895|Drug|Metoprolol ER (TM)|Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
11992102|NCT00648882|Drug|LEVOTHYROXINE SODIUM TABLETS,|2x300mcg, single dose fasting
11992103|NCT00648882|Drug|SYNTHROID® 300 mcg Tablets|2x300mcg, single dose fasting
11992104|NCT00648869|Drug|metformin tablet, metformin gum|500 mg, 250 mg
11992105|NCT00648856|Drug|Sertraline Hydrochloride Tablets 100 mg|100mg, single dose fed
11992106|NCT00648856|Drug|Zoloft® Tablets 100 mg|100mg, single dose fed
11992107|NCT00648843|Drug|Oxybutynin Chloride Extended-release Tablets 5 mg|4x5mg, single dose fed
11992108|NCT00648843|Drug|Ditropan XL® Tablets 5 mg|4x5mg, single dose fed
11992109|NCT00648830|Procedure|Clarithromycin|Single-dose of Clarithromycin 250 mg oral immediate-release tablets
11992110|NCT00648830|Drug|Clarithromycin|single-dose 250 mg immediate-release oral tablets
11992111|NCT00648817|Drug|Tenofovir Disoproxil Fumarate|Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil)
11992112|NCT00648817|Drug|Tenofovir DF placebo|Tenofovir DF placebo tablet QD
11992113|NCT00648804|Drug|Ondansetron Orally Disintegrating Tablets 8 mg|8mg, single dose fed
11992114|NCT00648804|Drug|Zofran ODT® Tablets 8 mg|8mg, single dose fed
11992115|NCT00648791|Drug|Finasteride Tablets 5 mg|5mg, single dose fasting
11992116|NCT00648791|Drug|Proscar Tablets 5 mg|5mg, single dose fasting
11992117|NCT00648778|Drug|Loxapine Succinate Capsules 25 mg|25mg, single dose fasting
11992118|NCT00648778|Drug|Loxitane® Capsules 25 mg|25mg, single dose fasting
11992119|NCT00648765|Drug|Anagrelide Hydrochloride Capsules 1 mg|1mg, single dose fed
11992120|NCT00648765|Drug|Agrylin® Capsules 1 mg|1mg, single dose fed
11992121|NCT00648739|Drug|Samalizumab|Samalizumab is a humanized anti-CD200 monoclonal antibody.
11992122|NCT00648726|Drug|cefuroxime plus erythromycin|intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days plus erythromycin ethylsuccinate 0.5 g twice daily, which was given for a total duration of 14 days for subjects with suspected pneumonia due to atypical pathogens
11992123|NCT00648726|Drug|azithromycin (Zithromax)|intravenous azithromycin 500 mg once daily for 4 +/-1 days, followed by oral azithromycin 500 mg once daily for a total duration of 9 +/-1 days
11992124|NCT00648726|Drug|cefuroxime|intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days
11992125|NCT00648713|Drug|Terbinafine Hydrochloride Tablets 250 mg|250mg, single dose fed
11992126|NCT00648713|Drug|Lamisil® Tablets 250 mg|250mg, single dose fed
11992127|NCT00648700|Drug|Levothyroxine Sodium Tablets 300 μg|2x300mcg, single dose fasting
11992128|NCT00648700|Drug|Levothroid® Tablets 300 μg|2x300mcg, single dose fasting
11992129|NCT00648687|Behavioral|suck 12.5% dextrose in water 5 minutes before the procedure|Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP
11992130|NCT00648674|Device|Apligraf|Applied at Day 0, possible re-application at Week 6
11992131|NCT00648661|Drug|Escitalopram Oxalate Tablets 20 mg|20mg, single dose fed
11992132|NCT00648661|Drug|Lexapro® Tablets 20 mg|20mg, single dose fed
11992133|NCT00648648|Drug|MK-1775|MK-1775 administered as an oral formulation as either monotherapy or in combination with either gemcitabine, cisplatin, or carboplatin.
11992134|NCT00648648|Drug|gemcitabine|Gemcitabine administered at 1000 mg/m^2 by IV infusion in a 28-day cycle.
11992135|NCT00648648|Drug|cisplatin|Cisplatin administered at 75 mg/m^2 by IV infusion in a 21-day cycle.
11992136|NCT00648648|Drug|carboplatin|Carboplatin administered at AUC/time curve of 5 mg/min/mL (AUC5) by IV infusion in a 21-day cycle.
11992137|NCT00648635|Behavioral|Questionnaire|Questionnaires taking 30-60 minutes to complete every 3 months.
11992138|NCT00648622|Drug|Carvedilol Tablets 12.5 mg|12.5mg, single dose fed
11992139|NCT00648622|Drug|Coreg® Tablets 12.5 mg|12.5mg, single dose fed
11992140|NCT00648609|Other|Palliative home care in advanced COPD|Interdisciplinary palliative care team on community based self care management of advanced COPD.
11992141|NCT00648609|Other|Standard of care|Usual care for COPD patients
11992142|NCT00648596|Drug|sildenafil|sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.
11992143|NCT00648596|Drug|placebo|placebo tablet by mouth 1 hour before sexual activity for 12 weeks
11992144|NCT00648583|Drug|Ondansetron Tablets 24 mg|24mg, single dose fed
11992145|NCT00648583|Drug|Zofran® Tablets 24 mg|24mg, single dose fed
11992146|NCT00648570|Drug|Escitalopram Oxalate Tablets 20 mg|20mg, single dose fasting
11992147|NCT00648570|Drug|Lexapro® Tablets (20 mg|20mg, single dose fasting
11992148|NCT00648557|Drug|Levothyroxine Sodium Tablets 200 mg|3x200mcg, single dose fasting
11992149|NCT00648557|Drug|Synthroid Tablets 200 mg|3x200mcg, single dose fasting
11992150|NCT00648544|Drug|Pravastatin|Single-dose 80 mg oral immediate-release tablet
11992151|NCT00648544|Drug|Pravastatin|Single-dose 80 mg oral immediate-release tablets
11992152|NCT00648531|Drug|Balsalazide Disodium Capsules 750 mg|3x750mg, single dose fasting
11992153|NCT00648531|Drug|Colazal® Capsules 750 mg|3x750mg, single dose fasting
11992154|NCT00648518|Drug|Metformin Hydrochloride ER Tablets 750 mg|750mg, single dose fasting
11992155|NCT00648518|Drug|Glucophage® XR Tablets 750 mg|750mg, single dose fasting
11992156|NCT00648505|Drug|Glipizide and Metformin HCl Tablets 5 mg/500 mg|5/500mg, single dose fed
11992157|NCT00648505|Drug|Metaglip® Tablets 5 mg/500 mg|5/500mg, single dose fed
11992158|NCT00648492|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fed
11992159|NCT00648492|Drug|Glucophage® XR 500 mg|500mg, single dose fed
11992160|NCT00648479|Device|The Guiding Star|
11992161|NCT00648479|Device|fluoroscopy (OEC 9800 - General Electric)|
11992162|NCT00648466|Drug|Sumatriptan Succinate Tablets 100 mg|100mg, single dose fasting
11992163|NCT00648466|Drug|Imitrex® Tablets 100 mg|100mg, single dose fasting
11992164|NCT00648453|Drug|Clopidogrel (Plavix)|
11992167|NCT00648427|Drug|Paroxetine Hydrochloride Controlled-Release Tablets 25 mg|25mg, single dose fasting
11992168|NCT00648427|Drug|Paxil CR™ Tablets 25 mg|25mg, single dose fasting
11992169|NCT00648414|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 1|blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow, while samples collected
11992170|NCT00648414|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 2|tourniquet applied just below patch application site and above blood draw site, while samples collected
11992171|NCT00648414|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 3|tourniquet applied just above patch application site, while samples collected
11992172|NCT00648414|Drug|Duragesic 25 mcg/h + Clinical Procedure 1|blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow
11992173|NCT00648414|Drug|Duragesic 25 mcg/h + Clinical Procedure 2|tourniquet applied just below patch application site and above blood draw site, while samples collected
11992174|NCT00648414|Drug|Duragesic 25 mcg/h + Clinical Procedure 3|tourniquet applied just above patch application site, while samples collected
11992175|NCT00648401|Drug|Verapamil Hydrochloride Extended-Release Capsules, 300 mg|300mg, single dose fed
11992176|NCT00648401|Drug|Verelan® PM Extended-Release Capsules, 300 mg|300mg, single dose fed
11992177|NCT00648388|Drug|Cilostazol Tablets 100 mg|100mg, single dose fasting
11992178|NCT00648388|Drug|Pletal® Tablets 100 mg|100 single dose fasting
11992179|NCT00648375|Drug|Propanolol|Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
11992180|NCT00648375|Drug|Placebo|Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
11992181|NCT00648375|Behavioral|Cognitive therapy workbook|Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
11992182|NCT00648362|Drug|Glimepiride Tablets 1 mg|1mg, single dose fasting
11992183|NCT00648362|Drug|Amaryl® Tablets 1 mg|1mg, single dose fasting
11992184|NCT00648349|Drug|Rabeprazole Sodium Delayed-Release Tablets 20 mg|20mg, single dose fasting
11992185|NCT00648349|Drug|Aciphex® Delayed-Release Tablets 20 mg|20mg, single dose fasting
11992186|NCT00648336|Drug|Mercaptopurine 50 mg|50mg, single dose fasting
11992187|NCT00648336|Drug|Purinethol® Tablets 50 mg|50mg, single dose fasting
11992188|NCT00648323|Drug|Doxazosin mysylate GITS|Subjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met.
11992189|NCT00648310|Drug|Tolterodine 4 mg|
11992190|NCT00648310|Drug|arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks|
11992191|NCT00648297|Drug|Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg|80/5mg, single dose fed
11992192|NCT00648297|Drug|Corzide® Tablets 80 mg/5 mg|80/5mg, single dose fed
11992193|NCT00648271|Drug|Metoprolol Tartrate Tablets 25 mg|2x50mg, single dose fed
11992194|NCT00648271|Drug|Lopressor® Tablets 50 mg|1x50mg, single dose fed
11992195|NCT00648258|Drug|valdecoxib|valdecoxib 10 mg tablet by mouth once daily for 6 weeks
11992196|NCT00648258|Drug|naproxen|naproxen 500 mg capsule by mouth twice daily for 6 weeks
11992197|NCT00648245|Drug|BIO-11006 Inhalation Solution|75 mg of BIO-11006 administered once per day for 21 days by nebulizer
11992198|NCT00648245|Drug|BIO-11006 Inhalation Solution|150 mg of BIO-11006 administered once per day for 21 days by nebulizer
11992199|NCT00648245|Drug|BIO-11006 Inhalation Solution|75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
11992200|NCT00648245|Drug|Placebo|Placebo given once daily for 21 days by nebulizer
11992201|NCT00648245|Drug|BIO-11006|125 mg BIO-11006 given twice per day for 21 days by nebulizer
11992202|NCT00648232|Behavioral|Voluntary brief HIV counseling and testing|Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
11992203|NCT00648232|Behavioral|Voluntary longer, more detailed HIV counseling and testing|Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
11992204|NCT00648232|Behavioral|Enhanced linkage to care|Participants will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their scheduled visits at the HIV clinics.
11992205|NCT00648232|Behavioral|Routine referral to care|Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
11992206|NCT00648219|Drug|Olmesartan Medoxomil Tablets 40 mg|40mg, single dose fed
11992207|NCT00648219|Drug|Benicar® Tablets 40 mg|40mg, single dose fed
11992208|NCT00648193|Drug|Paroxetine hydrochloride 40 mg tablet|40mg, single dose fasting
11992209|NCT00648193|Drug|Paxil® 40 mg Table|40mg, single dose fasting
11992210|NCT00648180|Drug|Doxycycline Monohydrate Tablets 100 mg|100mg, single dose fed
11992211|NCT00648180|Drug|Adoxa Tablets 100 mg|100mg, single dose fed
11992212|NCT00648167|Drug|ferric citrate|ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.
11992213|NCT00648154|Drug|Letrozole Tablets 2.5 mg|2.5mg, single dose fed
11992214|NCT00648154|Drug|Femara® Tablets 2.5 mg|2.5mg, single dose fed
11992215|NCT00648141|Drug|Celecoxib|200 mg oral capsule once daily for 12 weeks
11992216|NCT00648141|Drug|Celecoxib|200 mg oral capsule twice daily for 12 weeks
11992217|NCT00648141|Drug|Diclofenac|75 mg oral capsule twice daily for 12 weeks
11992218|NCT00648128|Drug|Clarithromycin|Single-dose 500 mg immediate-release oral tablet
11992219|NCT00648128|Drug|Clarithromycin|single-dose 500 mg immediate-release oral dose'
11992220|NCT00648115|Other|Basic Vocational Services|Vocational services
11992221|NCT00648115|Other|Self-Study|Veteran receives self-study resources
11992222|NCT00648115|Other|Group Program|Veteran participates in group vocational program
11992223|NCT00648102|Biological|CDX-1307|
11992224|NCT00648089|Drug|EPO|Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
11992225|NCT00648076|Drug|Divalproex Sodium Extended-Release Tablets 500 mg|500mg, single dose fed
11992226|NCT00648076|Drug|Depakote ER® Tablets 500 mg|500mg, single dose fed
11992227|NCT00648063|Drug|Letrozole Tablets 2.5 mg|2.5mg, single dose fasting
11992228|NCT00648063|Drug|Femara® Tablets 2.5 mg|2.5mg, single dose fasting
11992229|NCT00648050|Drug|Verapamil Hydrochloride Extended-Release Capsules, 300 mg|300mg, single dose fasting
11992230|NCT00648050|Drug|Verelan® PM Extended-Release Capsules, 300 mg|300mg, single dose fasting
11992231|NCT00648037|Drug|Rituximab|Rituximab 375 mg/m^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is > 200 cells/ul or a maximum of 6 doses have been given.
11992232|NCT00648024|Drug|Anagrelide Hydrochloride Capsules 1 mg|1mg, single dose fasting
11992233|NCT00648024|Drug|Agrylin® Capsules 1 mg|1mg, single dose fasting
11992234|NCT00648011|Drug|Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fed
11992235|NCT00648011|Drug|Accuretic™ Tablets 20 mg/25 mg|20/25mg, single dose fed
11992236|NCT00647998|Drug|Darbepoetin alfa|Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery
11992237|NCT00647998|Other|Standard care|
11992238|NCT00647985|Drug|Fexofenadine Tablets 180 mg|180mg, single dose fed
11992239|NCT00647985|Drug|Allegra® Tablets 180 mg|180mg, single dose fed
11992240|NCT00647972|Drug|Olanzapine Tablets 20 mg|20mg, single dose fasting
11992241|NCT00647972|Drug|Zyprexa® Tablets 20 mg|20mg, single dose fasting
11992242|NCT00647959|Drug|Doxycycline Tablets, 150mg|150mg, single dose fasting
11992243|NCT00647959|Drug|Adoxa Tablets 150 mg|150mg, single dose fasting
11992244|NCT00647946|Drug|tenofovir DF|tenofovir DF 300mg once daily along with the other antiviral drugs
11992245|NCT00647946|Drug|abacavir 300mg twice daily|abacavir 300mg twice daily along with the other antiviral drugs
11992246|NCT00647933|Drug|Org 36286|Subcutaneous Org 36286
11992247|NCT00647933|Drug|Lyndiol®|Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
11992248|NCT00647920|Biological|adalimumab|40 mg adalimumab sc, every other week
11992249|NCT00647920|Biological|placebo|placebo sc, every other week
11992250|NCT00647907|Drug|Voriconazole|Oral or intravenous voriconazole. Oral tablets 400 mg twice daily loading dose on first day, followed by 200 mg twice daily taken at least 1 hour before or after a meal. Oral doses could be increased to a maximum of 300 mg twice daily if there was no clinical improvement after at least 3 days of treatment, no serious adverse events were reported, and clinical chemistry parameters were within the acceptable range for study entry. Intravenous treatment was initiated with a loading dose of 6 mg/kg twice daily for the first day followed by 4 mg/kg twice daily for at least 3 days (maximum infusion rate of 3 mg/kg/hr if administered by peripheral intravenous line). An intravenous loading dose was not required in patients who were restarted after oral treatment. Total duration of therapy (intravenous and oral) was 12 weeks.
11992251|NCT00647894|Drug|Alprazolam Extended-Release Tablets 1 mg|
11992252|NCT00647894|Drug|Xanax XR Tablets 1 mg|
11992253|NCT00647881|Drug|Paroxetine Hydrochloride Controlled-Release Tablets 25 mg|25mg, single dose fed
11992254|NCT00647881|Drug|Paxil CR™ Tablets 25 mg|25mg, single dose fed
11992255|NCT00647868|Drug|testosterone|Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application
11992256|NCT00647855|Drug|Levothyroxine Sodium Tablets 300 μg|2x300mcg, single dose fasting
11992257|NCT00647855|Drug|Synthroid® Tablets 300 μg|2x300mcg, single dose fasting
11992258|NCT00647842|Drug|Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay|single application
11992259|NCT00647842|Drug|Fentanyl Transdermal System 25 mcg/h|single application
11992260|NCT00647829|Drug|valdecoxib|valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
11992261|NCT00647829|Drug|valdecoxib|valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
11992262|NCT00647829|Drug|placebo|placebo tablet by mouth for 2 doses over a 24-hour period
11992263|NCT00647816|Drug|Propranolol Hydrochloride Extended-Release Capsules 160 mg|160mg, single dose fasting
11992264|NCT00647816|Drug|Inderal® LA Capsules 160 mg|160mg, single dose fasting
11992265|NCT00647790|Procedure|PET scan with injection of 5-8 mCi of 18FES|Following injection of the tracer 18FES, dynamic images will be obtained for 30 minutes over the chest area to include cardiac region and breasts. Following the first dynamic imaging for 30 minutes, whole body images (base of skull to pelvis) will be obtained at 5 minute/bed position. An additional, longer scan after 60 minutes will be obtained for the chest (1-2-FOV for 15 minutes each). Total time from injection to completion of imaging will be about 90 minutes.
11992266|NCT00647777|Drug|Olanzapine Tablets 5 mg|5mg, single dose fed
11992267|NCT00647777|Drug|Zyprexa® Tablets 5 mg|5mg, single dose fed
11992268|NCT00647764|Drug|SNX-5422 Mesylate Hsp90 inhibitor|dose escalated, tablets twice a week; undetermined duration until disease progression
11992269|NCT00647751|Drug|Lamotrigine Tablets 25 mg|2x25mg, single dose fed
11992270|NCT00647751|Drug|Lamictal® Tablets 25 mg|2x25mg, single dose fed
11992271|NCT00647738|Drug|Baclofen|Single-dose 20 mg immediate-release oral tablets
11992272|NCT00647738|Drug|Baclofen|Single-dose 20 mg immediate-release oral tablet
11992273|NCT00647725|Procedure|Active phrase epidural analgesia|Continuous epidural analgesia with sufentanil plus ropivacaine
11992274|NCT00647725|Procedure|Latent phrase epidural analgesia|Continuous epidural analgesia with sufentanil plus ropivacaine
11992275|NCT00647712|Drug|Divalproex Sodium Extended-Release Tablets 500 mg|500mg, single dose fasting
11992276|NCT00647712|Drug|Depakote ER® Tablets 500 mg|500mg, single dose fasting
11992277|NCT00647699|Drug|riboflavin ophthalmic solution|riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
11992278|NCT00647699|Device|UVA Irradiation|UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
11992279|NCT00647686|Drug|Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay|single application
11992280|NCT00647686|Drug|Fentanyl Transdermal System 25 mcg/h|single application
11992281|NCT00647673|Drug|Verapamil HCL Extended-Release Capsules 300 mg|300mg, single dose fasting
11992282|NCT00647673|Drug|Verelan® PM Extended-Release Capsules 300 mg|300mg, single dose fasting
11992283|NCT00647660|Drug|Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg|80/5mg, single dose fasting
11992284|NCT00647660|Drug|Corzide® Tablets 80 mg/5 mg|80/5mg, single dose fasting
11992285|NCT00647647|Drug|Terbinafine Hydrochloride Tablets 250 mg|250mg, single dose fasting
11992286|NCT00647647|Drug|Lamisil® Tablets 250 mg|250mg, single dose fasting
11992287|NCT00647634|Drug|Alprazolam Extended-Release Tablets 3 mg|3mg, single dose fasting
11992288|NCT00647634|Drug|Xanax XR® Tablets (3 mg|3mg, single dose fasting
11992289|NCT00647621|Drug|Extended Phenytoin Sodium Capsules 100 mg|3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16
11992290|NCT00647621|Drug|Dilantin® Kapseals® 100 mg|3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16
11992291|NCT00647608|Drug|Propranolol Hydrochloride Extended-Release Capsules 160 mg|160mg, single dose fed
11992292|NCT00647608|Drug|Inderal® LA Capsules 160 mg|160mg, single dose fed
11992293|NCT00647595|Behavioral|Experimental group|Intervention group will exercise 3 times per week at moderate-vigorous intensity for 45 minutes per session. Control group women will continue their usual physical activity throughout pregnancy.
11992294|NCT00647582|Procedure|adjuvant therapy|
11992295|NCT00647582|Procedure|therapeutic conventional surgery|
11992296|NCT00647582|Radiation|intraoperative radiation therapy|
11992297|NCT00647582|Radiation|radiation therapy|
11992298|NCT00647569|Procedure|Mesh repair|A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.
11992299|NCT00647569|Procedure|Conventional facial closure|The abdominal facia is closed with with continuous running suture
11992300|NCT00647556|Drug|adapalene gel, 0.3%|applied topically once daily in the evening
11992301|NCT00647556|Drug|tretinoin 0.05% emollient cream|applied topically once daily in the evening
11992302|NCT00647543|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
11992303|NCT00647543|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
11992304|NCT00647543|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
11992305|NCT00647530|Biological|panitumumab|
11992306|NCT00647530|Drug|capecitabine|
11992307|NCT00647530|Drug|fluorouracil|
11992308|NCT00647530|Drug|oxaliplatin|
11992309|NCT00647517|Drug|Ultracet|"For the treatment arm: Tramadol 37.5 mg/APAP 325 mg combination tablets (Ultracet®) one tablet twice a day plus aceclofenac tablet per oral 100 mg twice a day.
~For the control group: Placebo plus aceclofenac tablet per oral 100 mg twice a day."
11992310|NCT00647491|Biological|adalimumab|20 mg sc eow
11992311|NCT00647491|Biological|adalimumab|40 mg sc eow
11992312|NCT00647491|Biological|adalimumab|80 mg sc eow
11992313|NCT00647491|Biological|placebo|placebo sc eow
11992314|NCT00647465|Drug|vaccine|IFNalpha 2b
11992315|NCT00647465|Drug|Placebo|Placebo
11992316|NCT00647452|Behavioral|Exercise|Moderate Intensity Exercise (50 % af VO2max) for 90 minutes
11992317|NCT00647426|Drug|Sorafenib + Docetaxel/Carboplatin|400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
11992318|NCT00647413|Behavioral|bio-chemical feedback and expert system intervention ETS|"Urinary cotinien will be measured using urine collected from the infants diaper. It will be analysed and the result will be explained to the participant in a written letter approximately 2 weeks after the intervention.
~The intervention will also be a counselling session about the consequences of ETS to the infant. The counselling will be guided by the principles of motivational intervieweing and an expert system letter tailored to the data assessed will be send to the participants"
11992319|NCT00647400|Biological|adalimumab|Adalimumab 40 mg every other week, subcutaneous
11992320|NCT00647400|Biological|adalimumab|Adalimumab 80 mg every other week, subcutaneous
11992321|NCT00647387|Device|Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)|Device
11992322|NCT00647374|Other|this is an observational study|
11992323|NCT00647361|Device|Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).|Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)
11992324|NCT00647348|Drug|Simvastatin|80mg simvastatin oral once daily for 24 months
11992325|NCT00647348|Drug|Placebo|Oral placebo tablet once daily for 24 months
11992326|NCT00647322|Other|Reduction of anti-epileptic medications|Reduction in anti-epileptic medications
11992327|NCT00647322|Procedure|No drug change|No change in anti-epileptic treatment
11992328|NCT00647296|Drug|KNS-760704|Oral tablet 2 x 12.5 mg twice daily for 12 weeks
11992329|NCT00647296|Drug|KNS-760704|Oral tablet 2 x 37.5 mg twice daily for 12 weeks
11992330|NCT00647296|Drug|KNS-760704|Oral tablet 2 x 75 mg twice daily for 12 weeks
11992331|NCT00647296|Drug|Placebo|Placebo oral tablet (2 tabs twice daily) for 12 weeks
11992332|NCT00647283|Procedure|Gradual immunosuppression drug withdrawal|After the obtention of biological samples (peripheral blood, liver tissue), enrolled patients undergo gradual weaning of all immunosuppressive therapy over a 6-9 month period under close medical supervision.
11992333|NCT00647270|Drug|adalimumab|Pre-filled syringe. See arm for more detail
11992334|NCT00647270|Drug|Placebo|Pre-filled syringe. See arm for more detail
11992335|NCT00647270|Drug|adalimumab|Pre-filled syringe. See arm for more detail
11992336|NCT00647257|Drug|Losartan|Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Losartan 100mg add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.
11992337|NCT00647257|Drug|Placebo|Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Placebo add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.
11992338|NCT00647244|Drug|Tenofovir disoproxil fumarate|Tenofovir disoproxil 245 mg oral tablet once daily
11992339|NCT00647244|Drug|Abacavir|Abacavir 300 mg oral tablet twice daily
11992340|NCT00647231|Drug|HKT-500 Topical Patch|Treatment with Ketoprofen Topical Patch
11992341|NCT00647231|Other|Placebo Patch|Treatment with placebo patch
11992342|NCT00647218|Drug|Post-operative adjuvant therapy|Adriamycin 60 mg/m2 IV over 20 minutes and Cytoxan 600 mg/m2 IV over 1 hour will be given every three weeks for 4 cycles.
11992343|NCT00647218|Drug|neoadjuvant therapy|Paclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles
11992344|NCT00647218|Procedure|therapeutic surgical procedure|Modified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy.
11992345|NCT00647218|Radiation|Radiation therapy with concurrent Paclitaxel|Radiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week
11992346|NCT00647218|Drug|Hormonal Therapy|After completion of postoperative adjuvant Adriamycin and Cytoxan, hormonal therapy should be given at the discretion of the treating physician for all post-menopausal ER and/or PR positive patients. It is also recommended for pre-menopausal patients who are ER and/or PR positive.
11992347|NCT00647205|Device|QuantiFERON TB Gold In-Tube|
11992348|NCT00647205|Device|T-SPOT.TB®|
11992349|NCT00647192|Drug|Eplerenone|50 mg per day
11992350|NCT00647192|Drug|Placebo|50 mg per day
11992351|NCT00647179|Procedure|Transsphenoidal adenomectomy|Surgery
11992352|NCT00647166|Drug|corticosteroid and azathioprine|"Corticosteroid 1 mg/kg/day with a conventional decrease dose
~Azathioprine : 2 mg/kg/day during one year in 2 to 3 times a day by oral route"
11992353|NCT00647166|Drug|corticosteroid and placebo|"Corticosteroid 1 mg/kg/day with a conventional decrease dose
~Placebo : 2 mg/kg/day during one year in 2 to 3 times a day by oral route"
11992354|NCT00647153|Other|pharmacological study|Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.
11992355|NCT00647153|Procedure|single photon emission computed tomography|One day post infusion
11992356|NCT00647153|Radiation|iodine I 123 anti-CEA recombinant diabody T84.66|10mCi/mg
11992357|NCT00647140|Other|18F-L-DOPA PET|PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA
11992358|NCT00647127|Drug|Buprenorphine|Buprenorphine: 20microg/h
11992359|NCT00647127|Drug|Fentanyl|Fentanyl: 25microg/h
11992360|NCT00647127|Drug|Placebo|Placebo: '5microg/h' (not active drug, it is just called '5microg/h')
11992361|NCT00647114|Biological|V930|V930 - Over a 94 week duration, patients will receive a series of 5 injections (2.5 mg/injection), one every other week. Within 2 minutes of each injection of V930, each patient will be given an EP-IM injection consisting of two 60 msec pulses.
11992362|NCT00647114|Biological|V932|V932 - Over a 94 week duration, patients will receive a series of 5 injections, 6 patients will initially received intramuscular V932 vaccinations at a low dose (0.5x109 vg/injection),and following a safety assessment, up to an additional 35 patients will be treated with the high dose V932 (0.5x1011 vg/injection).
11992363|NCT00647101|Drug|Latanoprost|Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months
11992364|NCT00647075|Dietary Supplement|Yunzhi extract|3.5 g/day
11992365|NCT00647075|Dietary Supplement|Placebo|Placebo (starch)
11992366|NCT00647049|Drug|methotrexate|8000mg/m2 i.v., max. 2 cycles
11992367|NCT00647049|Drug|Rituximab|375mg/m2, max. 8 times
11992368|NCT00647049|Drug|Cytarabine|3000mg/m2 die i.v., 2 days (max. 2 cycles)
11992369|NCT00647049|Drug|Thiotepa|40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
11992370|NCT00647049|Drug|Carmustin|400mg/m2 i.v. for 1 day
11992371|NCT00647036|Dietary Supplement|Isonitrogenous Vaminolact|Isonitrogenous Vaminolact
11992372|NCT00647036|Drug|Dipeptiven (L-glutamine- Lalanine)|0.6g/kg/day
11992373|NCT00647023|Drug|metformin|1000 mg metformin x 2 daily during 8 months
11992374|NCT00646984|Drug|Standard continuous antiretroviral therapy|
11992375|NCT00646984|Drug|CD-4 guided therapy interruption|Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
11992376|NCT00646984|Drug|Viral load driven treatment interruption|Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml
11992377|NCT00646971|Device|CPAP device|for 4 weeks
11992378|NCT00646971|Device|Placebo device|for 4 weeks
11992379|NCT00646958|Drug|Radezolid|450mg PO QD
11992380|NCT00646958|Drug|Radezolid|450mg PO BID
11992381|NCT00646958|Drug|Linezolid|600mg PO BID
11992382|NCT00646945|Drug|50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)|gas flow between 4 to 15 L/min
11992383|NCT00646945|Drug|50% Oxygen/50% Nitrogen premix|gas flow between 4 to 15 L/min
11992384|NCT00646932|Drug|paricalcitol|paricalcitol 0.04 mcg/kg three times a week
11992385|NCT00646932|Drug|paricalcitol|paricalcitol 0.08 mcg/kg three times a week
11992386|NCT00646932|Drug|paricalcitol|paricalcitol 0.16 mcg/kg three times a week
11992387|NCT00646932|Drug|paricalcitol|paricalcitol 0.24 mcg/kg three times a week
11992389|NCT00646906|Drug|Aspirin First|Crossover period Aspirin First: Subjects will receive 81 mg aspirin at approximately 8 am followed by acetaminophen at approximately 10 am.
11992390|NCT00646906|Drug|Aspirin Last|Crossover period Aspirin Last: Subjects will receive acetaminophen at approximately 8 am followed by 81 mg aspirin at approximately 10 am.
11992391|NCT00646906|Drug|Acetaminophen 1000 mg/d|Subjects will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM.
11992392|NCT00646906|Drug|Acetaminophen 4000 mg/d|Crossover period Acetaminophen 4000 mg/d: Acetaminophen (1000 mg p.o.) orally at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM.
11992393|NCT00646906|Drug|Ibuprofen 800 mg/d|Crossover period Ibuprofen 800 mg/d: Ibuprofen (200 mg) orally at at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM.
11992394|NCT00646893|Procedure|Preimplantation Genetic Diagnosis (PGD)|"one-cell embryo biopsy on day 3 of development. The cell will be analyzed by FISH using probes for X,Y,13,15,16,17,18,21,22 chromosomes. Cells with dubious results will be reanalyzed by no result rescue (Colls et al. 2007)"
11992395|NCT00646880|Drug|propiverine|Two week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.
11992396|NCT00646880|Drug|tolterodine PR|Two week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.
11992397|NCT00646867|Device|Tetrix|Twice daily topical application
11992398|NCT00646867|Device|Placebo|Twice daily topical application
11992399|NCT00646854|Drug|CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab|Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4
11992400|NCT00646854|Drug|CHOP14 chemotherapy (see specification under Arm B) plus G-CSF|6 cycles of CHOP every 2 weeks
11992401|NCT00646841|Drug|Doxazosin gastrointestinal therapeutic system (GITS)|4 mg/day, and was titrated, if necessary, to 8 mg/day at Week 3 (Visit 5) or Week 5 (Visit 6).
11992402|NCT00646815|Drug|growth hormone (genotropin)|Dosage regulation will follow the local recommendations of GHD treatment
11992403|NCT00646802|Drug|Progesterone|1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
11992404|NCT00646802|Drug|Placebo|1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
11992405|NCT00646789|Drug|Comparator: MK0633|patients will receive single 50mg oral dose with follow-up observation for 5 weeks.
11992406|NCT00646776|Drug|Rifabutin|Capsule, Oral, 150 mg, once daily, 11 Days
11992407|NCT00646776|Drug|Rifabutin + Atazanavir + Ritonavir|"Capsules, Oral, 18 Days
~Rifabutin (150 mg, 2x/wk)
~Atazanavir (300 mg, once daily)
~Ritonavir (100 mg, once daily)"
11992408|NCT00646763|Drug|G-CSF, GM-CSF administered at extremities|Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.
11992409|NCT00646763|Drug|G-CSF and GMCSF administered at abdomen|Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.
11992410|NCT00646750|Drug|Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)|"Day -21: rituximab. 250 mg/m2 iv
~Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi).
~Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1."
11992411|NCT00646737|Drug|Mycophenolate sodium|Mycophenolate sodium
11992412|NCT00646724|Biological|cotransplantation of islet and mesenchymal stem cell|islet of allograft and MSCs of autograft
11992413|NCT00646711|Drug|Depakote Delayed-Release/Depakote Sprinkle|Administered according to the subject's usual regimen.
11992414|NCT00646711|Drug|Depakote ER|Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
11992415|NCT00646685|Procedure|surgical technique: duct-to-duct biliary reconstruction|surgical reconstruction
11992416|NCT00646685|Procedure|surgical technique: roux-en-y biliary reconstruction|surgical reconstruction
11992417|NCT00646659|Biological|cetuximab|
11992418|NCT00646659|Drug|carboplatin|
11992419|NCT00646659|Drug|cisplatin|
11992420|NCT00646659|Drug|docetaxel|
11992421|NCT00646659|Drug|fluorouracil|
11992422|NCT00646659|Genetic|fluorescence in situ hybridization|
11992423|NCT00646659|Genetic|molecular genetic technique|
11992424|NCT00646659|Genetic|reverse transcriptase-polymerase chain reaction|
11992425|NCT00646659|Other|immunoenzyme technique|
11992426|NCT00646659|Other|immunohistochemistry staining method|
11992427|NCT00646659|Other|laboratory biomarker analysis|
11992428|NCT00646659|Procedure|biopsy|
11992429|NCT00646659|Radiation|3-dimensional conformal radiation therapy|
11992430|NCT00646659|Radiation|intensity-modulated radiation therapy|
11992431|NCT00646646|Drug|propofol|sedative
11992432|NCT00646646|Drug|dexmedetomidine|Sedative
11992433|NCT00646646|Drug|Midazolam|sedative
11992434|NCT00646646|Drug|saline placebo|saline placebo
11992435|NCT00646633|Procedure|Acupuncture and patient education|Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.
11992436|NCT00646620|Drug|budesonide/formoterol (Symbicort)|
11992437|NCT00646620|Drug|fluticasone/salmeterol (Advair Diskus)|
11992438|NCT00646620|Drug|albuterol (Ventolin)|
11992439|NCT00646607|Drug|FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)|To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
11992440|NCT00646607|Drug|FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)|standard treatment
11992441|NCT00646594|Drug|budesonide/formoterol (Symbicort)|
11992442|NCT00646594|Drug|fluticasone/salmeterol (Advair)|
11992443|NCT00646581|Drug|Placebo|Placebo
11992444|NCT00646581|Drug|Insulin (Humulin)|40 IU Intranasal Insulin will be administered once
11992445|NCT00646568|Drug|s.c. human chorionic gonadotropin (Pregnyl)|S.C. Pregnyl 10000 IU once
11992446|NCT00646542|Drug|Vildagliptin|
11992447|NCT00646542|Drug|Placebo|
11992448|NCT00646529|Drug|budesonide/formoterol (Symbicort)|
11992449|NCT00646529|Drug|budesonide (Pulmicort)|
11992450|NCT00646516|Drug|budesonide/formoterol (Symbicort)|
11992451|NCT00646503|Drug|Telbivudine|600 mg/day, oral telbivudine for 52 weeks
11992452|NCT00646477|Device|titration night|"Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes:
~in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes.
~in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events."
11992453|NCT00646451|Drug|pregabalin|75 mg bid to 300 mg bid based on per subject tolerability
11992454|NCT00646451|Drug|placebo capsules|up to 4 capsules bid as tolerated
11992455|NCT00646438|Drug|Strict Glycemic Control for one year post-op CABG|"The CDE and Study Coordinator will also meet with the patient in the hospital to show how the Lifescan One-Touch Ultra II glucometer works and review the study follow-up schedule. Patients will be sent home with the Lifescan One-Touch Ultra II glucometer and a supply of strips.
~Post-Discharge Period Patients will meet alternatively with the CDE and study doctor on a specific schedule including every week for the first month, every 2 weeks in the second month, and every month thereafter till the 12th month. During these sessions the BG records will be downloaded from the Lifescan One-Touch Ultra II glucometer and reviewed to see patterns and any areas that could be improved or changed.
~For all patients in the study arm, the medications that are being taken and the results of glucose monitoring charts will be reviewed weekly with endocrinologists so that any additional recommendations may be made to improve glucose control."
11992456|NCT00646425|Drug|Basiliximab|40 mg basiliximab administered as short iv infusion once every 2 weeks for 3 doses and at Weeks 8 and 12 for a total of 5 doses
11992457|NCT00646425|Drug|Placebo|Placebo to match basiliximab
11992458|NCT00646412|Device|A-Part® Gel|10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion
11992459|NCT00646399|Drug|Placebo|Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.
11992460|NCT00646399|Drug|Pagibaximab 50 mg/mL|Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23
11992461|NCT00646386|Drug|adalimumab|40 mg eow Week 0 - Week 24
11992462|NCT00646386|Drug|placebo for adalimumab|40 mg eow Week 0 - Week 24
11992463|NCT00646373|Other|Low Prime|The CPB circuit will be primed with mannitol (50 g of 20% solution) and crystalloid solution (Ringer's lactate) for a total volume of approximately 1200 ml.
11992464|NCT00646360|Dietary Supplement|DHA|400 mg/d of docosahexanoic acid (DHA) during pregnancy
11992465|NCT00646360|Dietary Supplement|Placebo|2 tablets daily during pregnancy
11992466|NCT00646347|Other|Conventional upper limb stroke rehabilitation|"Patient will be given a ten weeks conventional upper limb therapy. 3 sessions will be provided weekly in the first 4 weeks and 2 therapy sessions will be provided weekly in the subsequent 6 weeks. Patients will receive half an hour of conventional therapy in each session.
~Patient will be taught to carry out two and half hours conventional self practice exercise daily for a period of ten weeks."
11992467|NCT00646347|Device|Neuro Hand Orthosis Program (NHOP)|"The NHO is based on a design of dynamic hand orthosis for orthopaedic patients after hand surgery. We use it to support CVA patient's wrist and finger to perform grasping to transport an object (ball) from place to place to achieve the follows;
~NHO can assist stroke patients to experience successful hand grasping with an object and produce voluntary movement from their paralytic arm. This successful experience will positively reinforce the patient to continue to use their paralytic arm and change the patient's behavior and perception in the arm usage.
~The NHO Program is able to engage patients to perform their exercises and activities by themselves independently with the effect of intensive therapy.
~The intervention (NHOP) group will receive same treatment intensity as the control group but with a Neuro Hand Orthosis."
11992468|NCT00646334|Device|Mesh Implantation|An elective incisional Hernia repair is performed by using Optilene® Mesh Elastic, a lightweight and large pore mesh, knitted from monofilament polypropylene. Due to the multidirectional elasticity the mesh is able to adapt to all movements taking place in the abdominal wall.
11992469|NCT00646334|Device|Mesh Implantation|Ultrapro® Mesh is a knitted, partly absorbable, lightweight mesh, consisting of equal parts of nonabsorbable polypropylene and absorbable polyglecaprone (Monocryl®). Polyglecaprone is fully absorbed in the body by hydrolysis. The addition of polyglecapron filament is only intended to reinforce the mesh to allow a convenient intraoperative handling and mesh placement, without additional function. Ultrapro® is an elastic mesh having enlarged elasticity cross to the blue strips.
11992470|NCT00646321|Drug|budesonide/formoterol (Symbicort)|
11992471|NCT00646321|Drug|budesonide|
11992472|NCT00646295|Device|To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes|Pascal Dynamic Contour Tonometer Goldmann Applanation Tonometer
11992473|NCT00646282|Drug|doxercalciferol|The study drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
11992529|NCT00645866|Drug|epirubicin hydrochloride|
11992474|NCT00646269|Behavioral|Standard intervention protocol|The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.
11992475|NCT00646269|Behavioral|Standard intervention protocol + Cognitive training therapy|"Cognitive training therapy is provided in small groups of 5 to 8 patients. It consists in classroom type sessions designed to provide general cognitive stimulation. A set of standard cognitive exercises (involving memory, attention, or problem-solving…) related to activities of daily living is realized at each session."
11992476|NCT00646269|Behavioral|Standard intervention protocol + Reminiscence therapy|"Reminiscence therapy is provided in small groups of 5 to 8 patients. This therapy involves the discussion of past activities, events and experiences enhanced by aids such as photographs, familiar items, songs, or personal recordings. A particular topic of life (i.e. a wedding) is discussed at each session."
11992477|NCT00646269|Behavioral|"Standard intervention protocol + Made-to-measure program"|"The made to measure program involves no systematic intervention. The psychologist is asked to choose among the two possible therapies (Cognitive training therapy or Reminiscence therapy) the one more suitable for the patient after considering his clinical characteristics including socio-demographic characteristics, disease severity or cognitive and behavioural disturbance. It is an individualized approach emphasizing the importance of flexibility to allow adjustment to individual needs."
11992478|NCT00646256|Behavioral|COGPACK training, psychoeducation|Bifocal psychoeducation group program (Munich Psychoses Information Program - PIP) with preceding computerbased cognitive training program (COGPACK)
11992479|NCT00646230|Drug|fenretinide|
11992480|NCT00646230|Other|high performance liquid chromatography|
11992481|NCT00646230|Other|pharmacological study|
11992482|NCT00646217|Behavioral|Self Care Talk|6 weekly telephone sessions
11992483|NCT00646204|Drug|Memantine|10 mg bid
11992484|NCT00646204|Drug|placebo|2 tabs bid
11992485|NCT00646191|Drug|adalimumab|40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
11992486|NCT00646191|Drug|adalimumab|40 mg weekly through Week 48 (OL Week 12 - 48)
11992487|NCT00646191|Drug|adalimumab|80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
11992488|NCT00646178|Drug|adalimumab|40 mg adalimumab eow Week 0 - Week 12
11992489|NCT00646178|Drug|placebo for adalimumab|placebo eow Week 0 - Week 12
11992490|NCT00646165|Drug|Forodesine|
11992491|NCT00646152|Drug|Poly-ICLC|
11992492|NCT00646139|Drug|Src kinase inhibitor KX2-391|
11992493|NCT00646139|Other|immunoenzyme technique|
11992494|NCT00646139|Other|pharmacological study|
11992495|NCT00646126|Drug|Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)|Standard three day regimen
11992496|NCT00646126|Drug|placebo tablet similar to active drug in shape and size|Dosage similar to active drug(standard three days regimen)
11992497|NCT00646113|Device|OsseoSpeed™ TX 3.0S|OsseoSpeed™ TX 3.0 mm diameter
11992498|NCT00646100|Procedure|transcatheter arterial chemoembolization|chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.
11992499|NCT00646087|Drug|Ketamine|0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)
11992500|NCT00646087|Drug|Ketamine/Saline|0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11
11992501|NCT00646074|Behavioral|Self-Care Talk|6 conversational sessions
11992502|NCT00646061|Drug|buscopan|
11992503|NCT00646048|Device|TriVascular Stent-Graft System|TriVascular Stent-Graft System
11992504|NCT00646035|Drug|paricalcitol capsules|baseline iPTH/60
11992505|NCT00646009|Drug|budesonide/formoterol|
11992506|NCT00646009|Drug|fluticasone/salmeterol|
11992507|NCT00646009|Drug|albuterol|
11992508|NCT00645996|Dietary Supplement|Probiotics (L.acidophilus and B.lactis)|2.1 X 109 L.acidophilus and B.lactis
11992509|NCT00645996|Dietary Supplement|Cornflor|Cornflour 2 gram daily
11992510|NCT00645983|Dietary Supplement|Chamomile Extract|220 mg - 1100 mg daily
11992511|NCT00645983|Other|Placebo|1 to 5 capsules daily
11992512|NCT00645957|Procedure|penrose drain|incision and drainage of the infection with placement of a penrose drain
11992513|NCT00645957|Procedure|red rubber drain|incision and drainage of infection and placement of a red rubber drain
11992514|NCT00645944|Drug|Eszopiclone|Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
11992515|NCT00645944|Drug|Placebo|"Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
11992516|NCT00645931|Behavioral|protein and calorie controlled diet and self-hypnotic relaxation|daily
11992517|NCT00645918|Drug|clopidogrel|oral, 75 mg daily for 6 months starting on day of randomization
11992518|NCT00645918|Drug|placebo|oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization
11992519|NCT00645918|Drug|clopidogrel|oral, 450 mg loading dose on day of randomization; 75 mg daily for 6 months starting on day of randomization
11992520|NCT00645905|Drug|adalimumab|OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose
11992521|NCT00645905|Drug|placebo for adalimumab|OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose
11992522|NCT00645892|Drug|adalimumab|OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24
11992523|NCT00645892|Drug|placebo for adalimumab|OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24
11992524|NCT00645879|Drug|ornithine alpha ketoglutarate|A dose of 400 mg/kg up to 16 g per day was selected. Split into 2 doses taken for 4 weeks. If determined the drug with the best effect, drug will be taken for 30 weeks.
11992525|NCT00645879|Drug|glutamine|A dose of 400 mg/kg up to 16 g per day was selected. Split into 2 doses taken for 4 weeks. If determined the drug with the best effects, drug will be taken for 30 weeks.
11992526|NCT00645879|Drug|disodium citrate|Dose: 7.5 mEq/Kg or 658 mg/kg up to 16 g per day Split into 2 doses taken for 4 weeks. If determined the drug with the best effects, drug will be taken for 30 weeks.
11992530|NCT00645866|Other|laboratory biomarker analysis|
11992531|NCT00645866|Other|pharmacogenomic studies|
11992532|NCT00645866|Procedure|biopsy|
11992533|NCT00645866|Procedure|neoadjuvant therapy|
11992534|NCT00645866|Procedure|therapeutic surgical procedure|
11992535|NCT00645853|Drug|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
11992536|NCT00645853|Drug|VKA INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
11992537|NCT00645840|Drug|Anakinra|Patients will receive daily anakinra therapy for 28 days
11992538|NCT00645827|Other|IICE Dosing|Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
11992539|NCT00645827|Other|Healthcare Provider dosing|Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
11992540|NCT00645814|Drug|placebo for adalimumab|80 mg at Week 0 and 40 mg eow through Week 11
11992541|NCT00645814|Drug|adalimumab|80 mg at Week 0 and 40 mg eow through Week 11
11992542|NCT00645814|Drug|adalimumab|80 mg at Week 0 and 40 mg weekly through Week 11
11992543|NCT00645801|Drug|lubiprostone (Amitiza)|24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total
11992544|NCT00645801|Drug|Placebo|Amitiza Placebo
11992545|NCT00645788|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days
11992546|NCT00645788|Drug|Placebo|50 mg matching placebo powder formulation twice a day for 28 days
11992547|NCT00645788|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)
11992548|NCT00645788|Drug|Placebo|75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)
11992549|NCT00645775|Dietary Supplement|IGOB131|Comparison of 250 mg per day of Irvingia gabonensis to placebo
11992550|NCT00645762|Device|RS-Series Rhinosinusitis Treatment System|Single arm
11992551|NCT00645762|Device|FinESS Balloon|
11992552|NCT00645749|Biological|Helminth ova|2500 ova per dose (liquid form)
11992553|NCT00645736|Other|No intervention|No intervention
11992554|NCT00645723|Drug|Colistin|intravenous colistin and nebulized colistin
11992555|NCT00645723|Drug|Colistin and saline solution|intravenous colistin and nebulized saline solution
11992556|NCT00645710|Drug|gemcitabine hydrochloride|Given IV
11992557|NCT00645710|Drug|floxuridine|Given via hepatic arterial infusion
11992558|NCT00645710|Genetic|proteomic profiling|Correlative studies
11992559|NCT00645710|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|Correlative studies
11992560|NCT00645710|Other|liquid chromatography|Correlative studies
11992561|NCT00645710|Radiation|yttrium Y 90 anti-CEA monoclonal antibody cT84.66|Given IV
11992562|NCT00645710|Other|laboratory biomarker analysis|Correlative studies
11992563|NCT00645710|Other|mass spectrometry|Correlative studies
11992564|NCT00645710|Other|pharmacological study|Correlative studies
11992565|NCT00645684|Procedure|Gastrointestinal Anastomosis|Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
11992566|NCT00645671|Drug|0.5% Loteprednol Etabonate Ophthalmic Ointment|1/2 inch ribbon four times a day for 14 days
11992567|NCT00645671|Drug|Vehicle of Loteprednol Etabonate Ophthalmic Ointment|1/2 inch ribbon four times a day for 14 days
11992568|NCT00645658|Drug|Testim (1% testosterone gel)|Subjects apply contents of gel packet to skin daily.
11992569|NCT00645632|Drug|cisplatin|
11992570|NCT00645632|Drug|doxorubicin hydrochloride|
11992571|NCT00645632|Drug|ifosfamide|
11992572|NCT00645632|Drug|methotrexate|
11992573|NCT00645632|Procedure|adjuvant therapy|
11992574|NCT00645632|Procedure|neoadjuvant therapy|
11992575|NCT00645632|Procedure|therapeutic conventional surgery|
11992576|NCT00645606|Biological|Rituximab|rituximab :500 mg/m² every 8 weeks during 2 years
11992577|NCT00645593|Drug|Gemcitabine,|Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
11992578|NCT00645593|Drug|Cisplatin|Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle.
11992579|NCT00645593|Drug|Cetuximab|Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
11992580|NCT00645580|Drug|Fluvoxamine|Fluvoxamine 100mg/day PO for 6 weeks.
11992581|NCT00645567|Device|Unassisted Manual Transfer|No device assistance
11992582|NCT00645567|Device|Standard Transfer Board|Flat surface board
11992583|NCT00645567|Device|Glide n' Go|Flip down power lift chair
11992584|NCT00645567|Device|Easy Reach lift|Original chair is converted to a chair that swivels out of the vehicle and lowers to wheelchair height
11992585|NCT00645567|Device|Ryno lift|Lift for the wheelchair
11992586|NCT00645554|Drug|Galantamine oral solution|
11992587|NCT00645541|Procedure|Axillary Reverse Mapping|Lymphazurin, isosulfan blue dye, injected into arm then a standard axillary lymph node surgery to remove any blue dyed lymph nodes found (lymph nodes that have traveled down the drainage pathways).
11992588|NCT00645528|Other|Insulin Education Class|Participation in an Insulin Education Class at week 0 and week 2
11992589|NCT00645515|Drug|Ziprasidone|Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
11992590|NCT00645515|Drug|Risperidone|Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
11992591|NCT00645502|Drug|risperidone|
11992592|NCT00645489|Behavioral|psychoeducational|Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members
11992593|NCT00645489|Other|wait list|Wait list
11992594|NCT00645463|Drug|CP-945,598|20 mg CP-945,598 + 240 mg MR Diltiazem
11992595|NCT00645463|Drug|CP-945,598|20 mg CP-945,598 alone
11992596|NCT00645450|Drug|Propranolol|Weekly doses of short and long acting propranolol (Inderal, Inderal LA, Hemangeol, Inderal XL) following recollection of traumatic memory
11992597|NCT00645450|Drug|Placebo|Weekly doses of placebo (inactive pill) following recollection of traumatic memory
11992598|NCT00645437|Drug|Levofloxacin|
11992599|NCT00645424|Drug|atorvastatin|Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
11992600|NCT00645424|Drug|atorvastatin|Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
11992601|NCT00645424|Drug|atorvastatin|Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
11992602|NCT00645411|Biological|Cell culture-derived influenza subunit vaccine (cTIV)|One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
11992603|NCT00645411|Biological|Egg derived influenza subunit vaccine (eTIV)|One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
11992604|NCT00645411|Biological|Cell culture-derived influenza subunit vaccine (cTIV)|Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
11992605|NCT00645411|Biological|Egg derived influenza subunit vaccine (eTIV)|Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.
11992606|NCT00645398|Drug|Pregabalin|Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
11992607|NCT00645398|Drug|Pregabalin|Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
11992608|NCT00645398|Drug|Pregabalin|Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
11992609|NCT00645398|Drug|Placebo|Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
11992610|NCT00645385|Other|MRS Spectroscopy|"Magnetic Resonance Spectroscopy uses a continuous band of radio wave frequencies to excite hydrogen atoms in a variety of chemical compounds other than water. These compounds absorb and emit radio energy at characteristic frequencies, or spectra, that can be used to identify them. Generally, a color image is created by assigning a hue to each distinctive spectral emission. This comprises the spectroscopy part of MRS. MRS is still experimental, and is available in only a few research centers.
~Physicians mainly use MRS to study the brain and disorders such as epilepsy, Alzheimer's disease, brain tumors, and the effects of drugs on brain growth and metabolism. The technique is also useful in evaluating metabolic disorders of the muscles and nervous system. MRS is a noninvasive scan similar to an MRI that may be done at the same time as an MRI."
11992611|NCT00645372|Drug|Risperidone|Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6
11992612|NCT00645372|Drug|Ziprasidone|Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6
11992613|NCT00645359|Procedure|diffusion MRI|Diffusion MRI involves using MRI scanning to measure water transport at the cellular level. In this study, dMRI is being used to measure the response of tumors to chemotherapy.
11992614|NCT00645346|Biological|GBS glycoconjugate vaccine|Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.
11992615|NCT00645346|Biological|Placebo|Subjects will receive one dose of placebo
11992616|NCT00645333|Drug|MK-0752, Docetaxel, Pegfilgrastim|MK-0752 in escalating doses of 300, 450, 600, and 800 mg given orally on days 1-3, followed by docetaxel 80 mg/m2 day 8 and pegfilgrastim 6 mg SQ on day 9
11992617|NCT00645320|Drug|Ziprasidone|Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.
11992618|NCT00645307|Drug|Extended Release OROS® Paliperidone|
11992619|NCT00645294|Drug|Adefovir dipivoxil|0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8
11992620|NCT00645294|Drug|Adefovir Dipivoxil|0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8
11992621|NCT00645294|Drug|Adefovir Dipivoxil|ADV 10 mg on Day 1
11992622|NCT00645281|Drug|tolterodine extended release|Tolterodine ER capsule 4 mg daily for 12 weeks
11992623|NCT00645268|Drug|sildenafil|In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.
11992624|NCT00645268|Drug|placebo|In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.
11992625|NCT00645268|Drug|sildenafil|Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).
11992626|NCT00645255|Drug|placebo|placebo one capsule daily
11992627|NCT00645255|Drug|sibutramine or placebo|one capsule daily
11992628|NCT00645242|Drug|fluconazole|Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment
11992629|NCT00645229|Drug|Ziprasidone|Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks
11992630|NCT00645216|Drug|CP-945,598|Subjects take CP-945,598 alone for 21 days
11992631|NCT00645216|Drug|CP-945,598|Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21
11992632|NCT00645203|Drug|cefdinir|cefdinir oral suspension, 25 mg/kg once daily for 10 days
11992633|NCT00645190|Drug|Galantamine HBr|
11992634|NCT00645177|Drug|ABT-869|0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle
11992635|NCT00645177|Drug|paclitaxel|90 mg/m2 IV infusion over 1 hour, weekly every 3 out of 4 weeks
11992636|NCT00645177|Drug|Placebo for ABT-869|0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle
11992637|NCT00645164|Other|Ointment Vehicle|Subject acts as own control. 20 mg under Finn chambers
11992638|NCT00645164|Drug|Xenaderm|20 mg under Finn chambers
11992639|NCT00645151|Drug|Atorvastatin|Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
11992640|NCT00645151|Drug|Atorvastatin|Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
11992641|NCT00645151|Drug|Atorvastatin|Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
11992642|NCT00645138|Procedure|Paravertebral Block|"Sedation will be provided with midazolam and fentanyl. The transverse processes of T1-T6 will be located using ultrasound guidance. The area will be prepped with betadine. At each level, a 21 Gauge, 4-inch Stimuplex needle will be inserted in order to make contact with the transverse process. Once the transverse process has been located, the needle will be walked off the process and inserted 1 cm deep to its inferior border. After negative aspiration, 3 mL of 1.5% mepivacaine with epinephrine 1:200,000 and bicarbonate and 3 mL of 0.5% bupivacaine with epinephrine 1:200,000 will be injected. Sedation will be provided with 50-100 mcg/kg/min of propofol during the surgical procedure. Approximately 20 minutes before the end of the procedure, 4 mg of zofran will be administered."
11992643|NCT00645138|Procedure|General Anesthesia|Patients in the general anesthesia group will receive midazolam preoperatively for anxiolysis. Anesthesia will be induced with propofol and fentanyl. An LMA will be inserted and anesthesia maintained with sevoflurane in air and oxygen. 4 mg of zofran will be administered approximately 20 minutes before the end of the surgical procedure. The LMA will be removed and the patient will be transported to the PACU at the conclusion of the surgery.
11992644|NCT00645125|Drug|cefdinir (Omnicef)|2.5 ml of strawberry cream flavored oral suspension 125 mg/5 mL
11992645|NCT00645125|Drug|amoxicillin|2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL
11992646|NCT00645112|Drug|cefdinir (Omnicef)|oral suspension, 7 mg/kg every 12 hours for 5 days
11992647|NCT00645112|Drug|azithromycin|oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
11992648|NCT00645099|Drug|olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
11992649|NCT00645099|Drug|paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
11992650|NCT00645086|Drug|clarithromycin extended-release tablets|5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
11992651|NCT00645086|Drug|clarithromycin immediate-release tablets|7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
11992652|NCT00645073|Drug|cefdinir (Omnicef)|Two 300 mg cefdinir capsules on Study Days 1-10.
11992653|NCT00645073|Drug|levofloxacin|Two 250 mg levofloxacin capsules on Study Days 1-10
11992654|NCT00645060|Other|high performance liquid chromatography|Performed on serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples
11992655|NCT00645060|Other|pharmacological study|Serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples
11992656|NCT00645060|Procedure|radionuclide imaging|1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post Y-90 anti-CEA antibody infusion
11992657|NCT00645060|Procedure|single photon emission computed tomography|2 days and 3-5 days post antibody infusion
11992658|NCT00645060|Radiation|yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A|Dose escalation from 12 mCi/m2 through 18 mCi/m2 increasing by 2 mCi/m2 with each escalation
11992659|NCT00645047|Behavioral|Telemedicine CBT|Use of Videoconfrence Technology To Provide Cognitive Therapy
11992660|NCT00645047|Behavioral|In-Person CBT|In-Person Provision Of Cognitive Therapy
11992661|NCT00645034|Drug|placebo|placebo by mouth as a single dose
11992662|NCT00645034|Drug|sildenafil|sildenafil 100 mg by mouth as a single dose
11992663|NCT00645021|Drug|CP-945,598|Administration of CP-945,598 in subjects with mild hepatic function
11992664|NCT00645021|Drug|CP-945,598|Administration of CP-945,598 in subjects with moderate hepatic function
11992665|NCT00645021|Drug|CP-945,598|Administration of CP-945,598 in subjects with normal hepatic function
11992666|NCT00644995|Behavioral|Step Up Wellness Program|Participants in the Step Up Wellness program will receive weekly phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking.
11992667|NCT00644995|Behavioral|Usual care|Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
11992668|NCT00644982|Drug|sertraline|Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
11992748|NCT00644384|Genetic|gene expression analysis|
11992669|NCT00644982|Drug|venlafaxine XR|Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
11992670|NCT00644969|Drug|placebo|Randomization 2:1 treatment to placebo
11992671|NCT00644969|Drug|varenicline (CP-526,555)|One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
11992672|NCT00644956|Drug|tadalafil|tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
11992673|NCT00644956|Drug|sildenafil|sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
11992674|NCT00644943|Drug|cefdinir (Omnicef)|oral suspension (7 mg/kg, ql2hr) for 5 days
11992675|NCT00644943|Drug|amoxicillin|oral suspension (45 mg/kg/day, q l2 hours) for 10 days
11992676|NCT00644930|Device|the application of NPPV|ARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated. BIPAP Vision machine (Respironics, PA, USA) were used for NPPV.
11992677|NCT00644930|Device|invasive ventilation|Standard therapy group (invasive ventilation). Patients in need of endotracheal intubation were mechanically ventilated with Amadeus (Hamilton, Via Nova, Switzerland) and Esprit (Respironics, PA, USA) ventilators in the assist-control or synchronized intermittent mandatory ventilation (SIMV) mode.
11992678|NCT00644917|Drug|Xenaderm|20mg under Finn chambers
11992679|NCT00644917|Drug|Placebo|20mg under Finn chambers
11992680|NCT00644904|Dietary Supplement|Vitamin D3|
11992681|NCT00644904|Dietary Supplement|Vitamin D3|
11992682|NCT00644891|Drug|cefdinir (Omnicef)|2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml
11992683|NCT00644891|Drug|amoxicillin|2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 ml
11992684|NCT00644878|Drug|Nilotinib|Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.
11992685|NCT00644852|Other|Retrospective chart review study|Retrospective study chart review long acting risperidone
11992686|NCT00644839|Drug|CP-945,598|Administration of CP-945,598 alone in period 1
11992687|NCT00644839|Drug|CP-945,598|Adminstration of CP-945,598 with omeprazole in period 2
11992688|NCT00644826|Behavioral|preventive home visit|A multidimensional geriatric assessment within the dimensions: cognition, health related functioning, risk of falling, nutritional status, social situation, economic situation, mood. Two more home visits: (1) home counseling visit 2-3 weeks after assessment (2) booster session 1 month after home counseling visit
11992689|NCT00644813|Other|Scapular with glenoid neck fractures|
11992690|NCT00644800|Drug|Ziprasidone|Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment
11992691|NCT00644787|Drug|Fentanyl 1-day transdermal patch (Titration Phase)|Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.
11992692|NCT00644787|Drug|Fentanyl 1-day transdermal patch (Double Blind Phase)|Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
11992693|NCT00644787|Drug|Fentanyl 3-day transdermal patch (Double Blind Phase)|Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
11992694|NCT00644787|Drug|Placebo|Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.
11992695|NCT00644787|Drug|Placebo|Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.
11992696|NCT00644774|Drug|cefdinir (Omnicef)|2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml
11992697|NCT00644774|Drug|azithromycin|2.5 ml of cherry flavored oral suspension 100 mg/5 ml
11992698|NCT00644761|Drug|Adefovir Dipivoxil|Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
11992699|NCT00644748|Drug|gabapentin|"Gabapentin oral capsules:
~Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg"
11992700|NCT00644735|Drug|Esomeprazole|
11992701|NCT00644735|Drug|Lansoprazole|
11992702|NCT00644722|Device|MacIntosh Green Lite (metal single use laryngoscope blades)|metal single use laryngoscope blades
11992703|NCT00644722|Device|MacIntosh Green Spec II (metal reusable laryngoscope blades)|metal reusable laryngoscope blades
11992704|NCT00644709|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.
11992705|NCT00644696|Drug|Irinotecan and Bortezomib|Dose level-1a: IV Irinotecan 30 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-1: IV Irinotecan 35 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-2: IV Irinotecan 40 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-3: IV Irinotecan 45 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-4: IV Irinotecan 50 mg/m2/day, IV bortezomib 1.2mg/m2/day
11992706|NCT00644670|Drug|Atorvastatin|In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
11992749|NCT00644384|Genetic|northern blotting|
11992750|NCT00644384|Genetic|polymerase chain reaction|
11992751|NCT00644384|Genetic|protein expression analysis|
11992752|NCT00644384|Other|laboratory biomarker analysis|
11993925|NCT00636259|Drug|Bicalutamide (Casodex)|150mg
11992707|NCT00644670|Drug|Atorvastatin|In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
11992708|NCT00644657|Drug|Clopidogrel|All subjects will receive a 300 mg loading dose
11992709|NCT00644644|Other|Rapid Response Team (NTX wireless monitoring system)|If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.
11992710|NCT00644631|Drug|sildenafil|sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.
11992711|NCT00644631|Drug|placebo|placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks
11992712|NCT00644618|Drug|gemcitabine|a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3
11992713|NCT00644618|Other|125I brachytherapy PLUS gemcitabine|125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3
11992714|NCT00644605|Drug|sildenafil|sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
11992715|NCT00644605|Drug|sildenafil|sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
11992716|NCT00644605|Drug|placebo|placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
11992717|NCT00644605|Drug|sildenafil|sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
11992718|NCT00644592|Drug|Fenofibrate capsule daily for 4 weeks|Placebo capsule daily for 4 weeks
11992719|NCT00644592|Drug|Fenofibrate|160 mg/day orally for 4 weeks
11992720|NCT00644579|Drug|bLAC|bLAC high and low dose and placebo
11992721|NCT00644579|Drug|Placebo|Placebo
11992722|NCT00644566|Other|Shared Care|A psychologist co-located in the pediatric primary care clinic shared care with the subject's pediatrician. The psychologist offered regular appointments and psychoeducation. On an individual basis, parent management training, behavioral management training, individual psychotherapy, educational intervention assistance, teacher communication, and medication education were provided as needed.
11992723|NCT00644553|Drug|Clarithromycin|Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
11992724|NCT00644553|Drug|Amoxicillin|Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
11992725|NCT00644540|Biological|Influenza Trivalent Inactivated Vaccines|"This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
~Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
~Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm."
11992726|NCT00644540|Biological|Influenza Trivalent Inactivated Vaccines|"This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
~Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
~Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm."
11992727|NCT00644527|Other|Purpose designed music and sound listening program|Listening to one of two different specific music programs (Group A and B), which is composed for the treatment of depressive symptoms. The music is listened to during a period of 30 minutes in the morning and 30 minutes in the evening over 5 - 15 weeks.
11992728|NCT00644527|Other|Sham music for depression|Listening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks.
11992729|NCT00644514|Biological|Endotoxin - lipopolysaccharide (LPS)|Nebulized 5000EU, 10,000EU, 20,000EU endotoxin doses delivered to completion. Nebulized dose inhaled 30 minutes apart if no adverse events occur after the previous dose. Fiberoptic Bronchoscopy with Bronchoalveolar Lavage (BAL) and brush samples performed 24 hours after LPS nebulization.
11992730|NCT00644501|Drug|DiaPep277|1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.
11992731|NCT00644488|Drug|BMS-641988 (AR#2)|Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks
11992732|NCT00644475|Drug|Imidapril|tablets; 5, 10, 15, 20 mg; od; 12 weeks
11992733|NCT00644475|Drug|Candesartan|tablets; 8, 16, 24, and 32 mg; od; 12 weeks
11992734|NCT00644462|Device|PulmoTrack® 2010 with WIM-PC™ Technologies|wheeze detection during dynamic bronchial situations in infants
11992735|NCT00644449|Other|placebo|placebo
11992736|NCT00644449|Drug|azithromycin SR (Zithromax; compound: CP-62,993)|azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
11992737|NCT00644449|Other|placebo|placebo
11992738|NCT00644449|Drug|levofloxacin|500 mg (two 250 mg capsules) by mouth once daily for 7 days
11992739|NCT00644436|Device|Tetrix|single topical application
11992740|NCT00644436|Device|Tetrix|Single topical application
11992741|NCT00644423|Drug|Omega-3 Fatty Acid|One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
11992742|NCT00644423|Drug|Placebo|Matching Placebo
11992743|NCT00644410|Biological|Mesenchymal stromal cell|Mesenchymal stromal cells 20 - 40 mill.
11992744|NCT00644410|Biological|Saline|12 injection with 0.2 ml saline
11992745|NCT00644397|Device|95-degree Angled Blade Plate|
11992746|NCT00644397|Device|4.5mm Condylar Locking Plate|
11992747|NCT00644384|Drug|acitretin|
11992753|NCT00644371|Drug|Ibritumomab Tiuxetan (Zevalin)|"Conditioning Regimen
~Rituximab, 250 mg/m2 on days -21 and -14.
~Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.
~Chemotherapy:
~Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
~Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.
~Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:
~Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
~Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
~Melphalan 70 mg/m2/day on day -2 as a 15-min infusion."
11992754|NCT00644358|Drug|vilazodone|titration to 40 milligrams (mg) every day (qd) for 1 year
11992755|NCT00644332|Drug|Ranolazine|Oral dosage form.
11992756|NCT00644319|Drug|ibuprofen|
11992757|NCT00644319|Drug|morphine sulfate|
11992758|NCT00644319|Procedure|management of therapy complications|
11992759|NCT00644319|Procedure|pleurodesis|
11992760|NCT00644306|Drug|Thalidomide|100 mg/day continuously for 18 months
11992761|NCT00644306|Drug|melphalan, prednisone|12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
11992762|NCT00644306|Drug|melphalan, prednisone, thalidomide|12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
11992763|NCT00644293|Drug|azithromycin (Zithromax)|azithromycin 500 mg tablet by mouth once daily for 3 days
11992764|NCT00644293|Drug|placebo|placebo
11992765|NCT00644293|Drug|azithromycin SR|azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
11992766|NCT00644293|Drug|placebo|placebo
11992767|NCT00644280|Drug|Ranibizumab|intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
11992768|NCT00644267|Behavioral|Telemedicine|Telemedicine reporting of blood pressure, weight, physical activity
11992769|NCT00644254|Procedure|Pancreatic resection|PPPD, Whipple, Total pancreatectomy or left pancreatectomy.
11992770|NCT00644241|Biological|stem cell harvest|stem cells will be harvested from the iliac crest of the patients
11992771|NCT00644241|Procedure|angiographic transplantation of stem cells|autologous bone marrow derived stem cells will be transplanted in the gastroduodenal artery of the patient angiographically
11992772|NCT00644228|Drug|Bortezomib|Given IV
11992773|NCT00644228|Drug|Dexamethasone|Given PO
11992774|NCT00644228|Other|Laboratory Biomarker Analysis|Optional correlative studies
11992775|NCT00644228|Drug|Lenalidomide|Given PO
11992776|NCT00644215|Drug|5-FU and Mitomycin|"5-FU injection 5mg
~Mitomycin drop 0.02%"
11992777|NCT00644202|Behavioral|Counseling Sessions|Counseling Sessions at each study visit around diet and physical activity from a registered dietician
11992778|NCT00644202|Behavioral|Specialized Website|Specialized website that allows participants to track their eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants
11992779|NCT00644202|Behavioral|Telephone Counseling Calls|5 telephone calls with a health counselor, lasting 15-20 minutes each.
11992780|NCT00644189|Drug|Clofarabine|Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
11992781|NCT00644176|Drug|azithromycin immediate release (Zithromax)|azithromycin IR 500 mg tablet by mouth for 1 dose
11992782|NCT00644176|Other|placebo|placebo
11992783|NCT00644176|Drug|azithromycin SR|2.0 g by mouth in the form of liquid for 1 dose
11992784|NCT00644176|Other|placebo|placebo
11992785|NCT00644163|Behavioral|Eban HIV/STD Risk Reduction Intervention|The eight-session Eban HIV/STD Risk Reduction Intervention is embedded in a cultural context and is gender tailored in its prevention messages and activities. Sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations.
11992786|NCT00644163|Behavioral|Eban Health Promotion Intervention|The eight-session Eban Health Promotion Intervention is guided by a social cognitive approach that engages health promotion skills. Sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence.
11992787|NCT00644150|Behavioral|Physician Ai Shi Zi training|This training uses a curriculum developed specifically for Project Ai Shi Zi and includes training in stigma; risk-reduction counseling; and quality HIV/STI diagnosis, treatment, and management. Physician training will consist of multiple components: an orientation workshop on fundamental knowledge and skills of HIV/STI treatment and prevention, a 3-month practice period, a 3-month post-practice seminar on preventive counseling, another 3-month practice period, and a 6-month post-practice seminar on clinical HIV and STI management. The practice periods will promote learning-by-doing to further enhance physicians' abilities to deliver high quality, integrated HIV/STI prevention and treatment. Post-practice seminars will allow participants to share experiences gained during the previous 3-month practice period.
11992788|NCT00644150|Drug|Standard care|If an STI is confirmed by a lab test, participants will receive standard of care treatment. Gonorrhea will be treated with a single dose of 250 mg of ceftriaxone sodium administered by intramuscular injection. If patients are allergic to ceftriaxone, they will be treated with azithromycin (2 g single oral dose). Chlamydia will be treated with azithromycin (1 g single oral dose).
11992789|NCT00644150|Behavioral|Patient risk-reduction counseling|On the initial visit, participants will receive HIV/STI risk-behavior counseling from the physician trained in Ai Shi Zi. The process is based on motivational interviewing techniques and will include discussing topics such as partner notification, HIV/STI prevention, and expected difficulties in changing behaviors. This risk-reduction model encourages the HIV/STI-infected or -uninfected person to develop a risk-reduction plan. The objective is to decrease the chance of infection for that individual and for others, too. Patients will develop a list of risk-reduction strategies to follow.
11992790|NCT00644137|Drug|pregabalin|Help stop smoking
11992791|NCT00644137|Other|cigarettes|help stop smoking with study medication
11992792|NCT00644124|Drug|aflibercept|in combination with standard treatment R-CHOP
11992793|NCT00644111|Drug|Bupivicaine, Hydromorphone|0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
11992794|NCT00644111|Drug|Saline Placebo|Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
11992795|NCT00644098|Dietary Supplement|soluble fibre complex and medium chain triglycerides|
11992796|NCT00644098|Dietary Supplement|cellulose and soybean oil|
11992797|NCT00644085|Drug|aspirin|oral administration of aspirin 100 mg
11992798|NCT00644085|Drug|placebo|oral administration of placebo
11992799|NCT00644072|Drug|SNX-5422|
11992800|NCT00644059|Biological|Adjuvanted trivalent inactivated subunit influenza vaccine|Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
11992801|NCT00644059|Biological|Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine|For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
11992802|NCT00644059|Biological|Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine|"Meningococcal vaccine: two IM injections
~Tick-borne encephalitis vaccine: two IM injections"
11992803|NCT00644046|Behavioral|multidisciplinary predialysis education|teaching of renal knowledges, dietary support and recall of period medical visits
11992804|NCT00644033|Drug|Frovatriptan|2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
11992805|NCT00644033|Drug|Frovatriptan|2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
11992806|NCT00644033|Drug|Placebo|placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.
11992807|NCT00644020|Drug|mitomycin, Fluorouracil|All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.
11992808|NCT00644007|Drug|Placebo|Placebo as a substitute of SK3530 100mg
11992809|NCT00644007|Drug|SK3530|SK3530 100 mg
11992810|NCT00643994|Radiation|CyberKnife Stereotactic Radiosurgery|36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
11992811|NCT00643981|Biological|MESENDO|"2 ml of the final cell mixture will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel."
11992812|NCT00643968|Drug|EFV+TDF|
11992813|NCT00643968|Drug|EFV+3TC+TDF|
11992814|NCT00643955|Other|muscle strength|muscle strength
11992815|NCT00643942|Other|No intervention required|
11992816|NCT00643929|Drug|Eltrombopag|Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo
11992817|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 9 and 12 months)
11992818|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 9 and 15 months)
11992819|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 12 and 15 months)
11992820|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 15 months)
11992821|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 18 months)
11992822|NCT00643916|Biological|A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)|0.5 mL, Subcutaneous (at 3 years to <6 years of age)
11992823|NCT00643903|Behavioral|Cognitive behavioral coping effectiveness training|Coping effectiveness training will include five individual 90-minute counseling sessions. The sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
11992824|NCT00643903|Behavioral|Standard care|Participants will receive standard of care for HIV infections.
11992825|NCT00643903|Behavioral|Single group workshop on coping effectiveness training|Participants will attend one group workshop covering the same material as in the individual sessions. The workshop will be delivered after completion of the Month 18 final assessment.
11992826|NCT00643890|Genetic|Bilateral surgical infusion of AAV-GAD into the subthalamic nucleus|One-time bilateral administration of rAAV-GAD at 1X10^12 vector genomes in 35 uL.
11992827|NCT00643877|Procedure|Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR|PHRAC which included of two parts(common hepatic artery chemotherapy and main tumor supplying artery chemotherapy) was performed 7 days before surgery： common hepatic artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg main tumor supplying artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg
11992828|NCT00643877|Procedure|surgery|radical surgery only
11992829|NCT00643864|Behavioral|mirror training|"Training will be performed one-on-one by an investigator in a quiet room, one hour a day, five days a week, for four weeks. Attendance will be recorded. The mirror-box apparatus consists of an 18 x 24 vertical mirror secured in the center of a wooden platform. During training, the mirror-box will be placed on a table in front of the subject so that the mirror is perpendicular to the chest, slightly lateral of midline. Subjects will be asked to attend to the mirror reflection of their unaffected hand performing a series of tasks, while keeping their affected limb still. At the end of the four week training period, posttests will be administered by the same Occupational Therapist who performed the pretests."
11992830|NCT00643851|Drug|Dapagliflozin|Tablets, Oral, Once daily, 24 weeks
11992831|NCT00643851|Drug|Metformin XR|Tablets, Oral, Once daily, 24 weeks
11992832|NCT00643838|Drug|Kalinox 170 bar|Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
11992833|NCT00643825|Drug|Temozolomide|Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
11992834|NCT00643825|Drug|Temozolomide|Observation till Progression then rechallenging with TMZ
11992835|NCT00643812|Other|Installation of gun locker in household|Households were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. Early arm received gun lockers at baseline.
11992836|NCT00643812|Other|Installation of gun locker in household|"Households were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. Late arm received the gun locker 12 months after baseline."
11992837|NCT00643799|Drug|Celecoxib|200 mg oral capsule once daily for 6 months
11992838|NCT00643799|Drug|Naproxen|500 mg oral capsule twice daily for 6 months
11992839|NCT00643799|Drug|Placebo|Matched oral placebo for 6 months
11992840|NCT00643786|Drug|Oxygène|Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
11992841|NCT00643786|Drug|Air Médical|Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
11992842|NCT00643773|Dietary Supplement|Leucine|capsules are 0.5g, subjects take 5 capsules with every main meal for 6 months In total this is 15 capsules per day
11992843|NCT00643773|Dietary Supplement|Wheat flour|Wheat flour
11992844|NCT00643760|Drug|Placebo|placebo
11992845|NCT00643760|Drug|GEn 1200mg/day|gabapentin enacarbil 1200mg/day
11992846|NCT00643760|Drug|GEn 2400mg/day|gabapentin enacarbil 2400mg/day
11992847|NCT00643760|Drug|GEn 3600mg/day|gabapentin enacarbil 3600mg/day
11992848|NCT00643760|Drug|Pregabalin|pregabalin 300mg/day
11992849|NCT00643747|Biological|tgAAG76 (rAAV 2/2.hRPE65p.hRPE65)|Single subretinal injection of vector suspension; up to 3x10e12 vector particles
11992850|NCT00643734|Drug|azithromycin sustained release|azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
11992851|NCT00643734|Other|placebo|placebo
11992852|NCT00643734|Drug|levofloxacin|500 mg (two 250 mg capsules) by mouth once daily for 7 days
11992853|NCT00643734|Other|placebo|placebo
11992854|NCT00643721|Other|dehydration|dehydration to 3% and 5% loss of total body water
11992855|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group A, one point per ovary.
11992856|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group B, two points per ovary.
11992857|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group c, three points per ovary.
11992858|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group D, four-five points per ovary.
11992859|NCT00643695|Behavioral|Home-based walking program|The exercise intervention is a 12 week home-based exercise program. Ideally Individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual.
11992860|NCT00643695|Other|Educational intervention|Participants in the control group will receive a packet of information regarding hepatitis C
11992861|NCT00643682|Other|Educational card|"A 4x6 inch educational card containing a photo of an unprepared colon and a clean colon with the caption: Drinking all the bowel cleaning medicine as described in the enclosed instructions lets the doctor see your colon better during your colonoscopy."
11992862|NCT00643669|Drug|AL-3789 Sterile Suspension|Single administration by anterior juxtascleral depot
11992863|NCT00643656|Drug|Kalinox 170 bar|Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
11992864|NCT00643656|Drug|Mix of 50% oxygen and 50% nitrogen|Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
11992865|NCT00643643|Drug|Maraviroc (UK-427,857)|25 mg oral tablet once daily for 10 days
11992866|NCT00643643|Drug|Maraviroc (UK-427,857)|50 mg oral tablet twice daily for 10 days
11992867|NCT00643643|Drug|Maraviroc (UK-427,857)|100 mg oral tablet twice daily for 10 days
11992868|NCT00643643|Drug|Maraviroc (UK-427,857)|300 mg oral tablet twice daily for 10 days
11992869|NCT00643643|Other|Placebo|Matching placebo oral tablet twice daily for 10 days
11992870|NCT00643630|Device|Tetrix|Twice daily topical application
11992871|NCT00643630|Device|Tetrix|Twice daily topical application
11992872|NCT00643617|Radiation|CyberKnife Stereotactic Radiosurgery|38 Gy delivered in 4 fractions of 9.5 Gy per fraction
11992873|NCT00643604|Drug|treprostinil sodium|rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
11992874|NCT00643591|Other|imaging (dynamic PET-CT scan)|dynamic PET-CT scan
11992875|NCT00643578|Drug|formoterol|a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
11992876|NCT00643578|Drug|formoterol|a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
11992877|NCT00643578|Device|Dry Powder Inhaler (Twisthaler)|subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
11992878|NCT00643565|Drug|Standard chemotherapy|As prescribed
11992879|NCT00643565|Drug|bevacizumab [Avastin]|7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
11992880|NCT00643539|Drug|Zithromax|azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days
11992881|NCT00643539|Drug|Clamoxyl|Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days
11992882|NCT00643526|Device|Pre-filled Auto-injector Containing Placebo|Participants will self-inject placebo subcutaneously at thigh and abdomen.
11992883|NCT00643500|Drug|Levetiracetam|
11992884|NCT00643487|Procedure|observation of the behavior of the infrapatellar plica|Local anesthesia using bupivicaine will be initiated. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises. Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
11992885|NCT00643474|Device|Accu-Chek Aviva Meter|4-point daily glucose monitoring profile 3 times per week
11992886|NCT00643474|Device|Accu-Chek Aviva Meter|Frequency and timing of SMBG not specified
11992887|NCT00643461|Device|Adhesive A|Applied per manufacturer's instructions.
11992888|NCT00643461|Device|Adhesive B|Applied per manufacturer's instructions.
11992889|NCT00643461|Device|Adhesive C|Applied per manufacturer's instructions.
11992890|NCT00643448|Drug|AZD1305|AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
11992891|NCT00643448|Drug|AZD1305|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
11992892|NCT00643448|Drug|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
11992893|NCT00643435|Behavioral|Self-efficacy enhancing interviewing techniques training|Teaching by standardized patient instructors regarding use of self-efficacy enhancing interviewing techniques to be applied in patient encounters
11992894|NCT00643435|Behavioral|Control intervention|These residents receive training provided by a standardized patient instructor, regarding the common co-occurrence of chronic medical and mental health problems, without any interviewing technique discussion or training.
11992895|NCT00643422|Device|Cirrus™ HD-OCT, Carl Zeiss Meditec AG|the retinal thickness and volume is determined on two different days with the Cirrus™ HD-OCT.
11992896|NCT00643409|Drug|azithromycin SR (Zithromax; compound: CP-62,993)|Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
11992897|NCT00643409|Other|placebo|placebo
11992898|NCT00643409|Drug|levofloxacin|levofloxacin 500 mg capsule by mouth qd x 10 days
11992899|NCT00643409|Other|placebo|placebo
11992900|NCT00643396|Radiation|thoracic radiotherapy|
11992901|NCT00643383|Drug|Combination drug (Acetaminophen + Tramadol)|
11992902|NCT00643383|Drug|Placebo|
11992903|NCT00643370|Other|CT scan of the chest under deep inspiration breath hold|computed tomography scan of the chest under dep inspiration breath hold conditions
11992904|NCT00643357|Drug|50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)|gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes
11992905|NCT00643357|Drug|50%Oxygen/50% Nitrogen premix|inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min
11992906|NCT00643344|Behavioral|Craving and Lifestyle Management through Mindfulness(CALMM+)|MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).
11992907|NCT00643331|Behavioral|Exercise|Exercise performed at gym and at home comprising strength, balance and impact exercise
11992908|NCT00643318|Radiation|CyberKnife Stereotactic Radiosurgery|"Central tumors defined as < 2 cm from carina and < 2 cm from right and left mainstem bronchus and/or < 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy)
~Peripheral tumors are defined as being > 2 cms from the carina and > 2 cms from the right and left mainstem bronchus and/or > 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)"
11992909|NCT00643305|Behavioral|Skills Building with Motivational Interviewing|Based on the Stages of Change model, participants are provided with feedback related to their current HIV risk and Motivational Interviewing strategies are used to increase motivation to decrease HIV risk behaviors. Participants are also provided with information and training in skills critical for reducing HIV risk
11992910|NCT00643305|Behavioral|Skills Building|Participants are provided with information and training in skills critical for reducing HIV risk.
11992911|NCT00643292|Drug|amoxicillin/clavulanate postassium (Augmentin ES-600)|amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
11992912|NCT00643292|Drug|azithromycin SR|azithromycin SR 60 mg/kg x 1 dose
11992913|NCT00643279|Device|Chronicle Implantable Hemodynamic Monitor|Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
11992914|NCT00643279|Other|Standard of Care|Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.
11992915|NCT00643266|Behavioral|Recollection Training|"Participants are exposed to long lists of words. Each word is presented either visually or auditorily, and each word is repeated after a variable number of intervening words (the lag), in each the same modality, or the other modality. Participants are instructed to respond yes only to words repeated in the same modality. If a performance criterion is met, the lag is increased for the next session; if the performance criterion is not met, the same lag is repeated in the next session."
11992916|NCT00643266|Behavioral|Control|Participants view PowerPoint presentations on various topics related to memory and aging (e.g., structural brain changes, diet, stress, depression) and how each of these topics affect memory, and after each presentation, play a Jeopardy-like game to test their knowledge gain
11992917|NCT00643253|Behavioral|LC and Electronic Prompt|Women will receive: a) International Board of Certified Lactation Consultant (IBCLC) education/counseling during the pre-natal, intra-partum and post-hospital discharge period to promote early and continued exclusive breastfeeding. The protocol specifies 2 prenatal meetings, a hospital visit, and a home visit if indicated and accepted, and; b) Electronic Medical Record Prompts- will appear on the prenatal record 5 times throughout the pregnancy. They are brief discussion points re breastfeeding that the provider is asked to raise with their patients.
11992918|NCT00643240|Radiation|yttrium Y 90 anti-CD19 monoclonal antibody BU12|Patients in whom the biodistribution is as expected (unaltered) AND a HAMA response does not develop will receive a single dose of 90Y-BU-12 in a dose escalated manner to establish the maximum tolerated dose (MTD) of 90Y-BU-12 over 60 minutes on Day 0. A single course of BU-12 includes the imaging dose of 111In-BU-12 followed 7-8 days later by the therapy dose of 90YBU- 12.
11992919|NCT00643240|Radiation|111In-BU-12|Patients receive indium-111 BU-12 IV over 60 minutes on day 0
11992920|NCT00643227|Drug|clarithromycin extended release (ER)|7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
11992921|NCT00643227|Drug|azithromycin SR|Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
11992922|NCT00643214|Device|Tetrix|Twice daily topical application
11992923|NCT00643214|Device|Tetrix|Twice daily topical application
11992924|NCT00643201|Drug|Enoxaparin|solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.
11992925|NCT00643201|Drug|warfarin|tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
11992926|NCT00643201|Drug|Placebo for apixaban|tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
11992927|NCT00643201|Drug|Placebo for enoxaparin|solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
11992928|NCT00643201|Drug|Placebo for warfarin|tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
11992929|NCT00643201|Drug|apixaban|tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
11992930|NCT00643188|Procedure|Radiofrequency ablation|Radiofrequency ablation of atrial fibrillation
11992931|NCT00643188|Other|Conventional treatment|The best medical treatment according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult and the ACC/AHA/ESC 2006 Guidelines for Management of Patients with Atrial Fibrillation.
11992932|NCT00643175|Behavioral|Automated follow up|Treatment of osteoporosis after hip fracture is also being targeted as a future hospital quality assessment measure. Hospitals which have no plan in place to address osteoporosis treatment after hip fracture may be cited, and may have medicare money withheld. The goal of the study is to create an automated in-patient endocrinology consultation for osteoporotic hip fractures. We plan to gather patient data in a prospective manner including the endocrinologist recommendations, adherence to medical therapy after discharge, and future fracture rates. Planned interventions include only appropriate medical therapy for osteoporosis, DEXA bone scanning, and regularly scheduled telephone follow-up.
11992933|NCT00643162|Drug|Lexapro|5mg-10mg of lexapro, daily, for 9 weeks for all study participants.
11992934|NCT00643162|Behavioral|Light touch|Light touch twice a week, for 8 weeks
11992935|NCT00643162|Behavioral|Massage|Massage twice a week, for 8 weeks.
11992936|NCT00643149|Drug|amoxicillin|10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
11992937|NCT00643149|Drug|azithromycin SR|60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat
11992938|NCT00643136|Drug|Pregabalin|Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
11992939|NCT00643136|Drug|Placebo|Matching placebo capsules twice daily for 28 days
11992940|NCT00643123|Drug|Allopurinol|300-600 mg/day over a 6 week period
11992941|NCT00643123|Other|Placebo|Inactive substance
11992942|NCT00643110|Drug|D50 glucose|D50 glucose would be administered, if necessary.
11992943|NCT00643097|Biological|PEP-3 vaccine|Given intradermally
11992944|NCT00643097|Biological|sargramostim|Given intradermally
11992945|NCT00643097|Drug|Temozolomide|Standard of care chemotherapy
11992946|NCT00643084|Procedure|low residue diet/no standard bowel preparation|low residue diet/no standard bowel preparation
11992947|NCT00643084|Procedure|standard bowel preparation|standard bowel preparation
11992948|NCT00643071|Drug|Tacrolimus|Oral
11992949|NCT00643058|Biological|LPS endotoxin|"Low challenge: saline (diluent), 5000EU, 10,000EU and 20,000EU LPS endotoxin as tolerated
~High challenge: Saline (diluent), 40,000EU and 80,000EU as tolerated
~Diluent Challenge: 3 X Sterile saline inhalation (2 ml)"
11992950|NCT00643045|Drug|Safinamide|
11992951|NCT00643045|Drug|Safinamide|
11992952|NCT00643045|Drug|Placebo|
11992953|NCT00643032|Procedure|Transcutaneous iliohypogastric|
11992954|NCT00643032|Procedure|Perioperative administration near the nerve|
11992955|NCT00643019|Behavioral|SAFE Behavioral Intervention|Group cognitive behavioral intervention sessions
11992956|NCT00643019|Other|Control|Individual Sexually Transmitted Infection Risk Reduction Counseling
11992957|NCT00643006|Behavioral|Physical exercise|Supervised walks with poles twice a week at moderate-high intensity
11992958|NCT00643006|Behavioral|Active comparator: low intensive exercise|Supervised walks once a week at low-intensity.
11992959|NCT00642993|Drug|SCH 497079|100 mg capsule administered orally
11992960|NCT00642993|Drug|Placebo|Placebo capsules matching SCH 497079 administered orally
11992961|NCT00642980|Drug|Clindamycin|300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
11992962|NCT00642980|Drug|Placebo|Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
11992963|NCT00642980|Drug|Clindamycin|300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart
11992964|NCT00642967|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|s.c. every 4 weeks (starting dose based on previous ESA therapy)
11992965|NCT00642954|Drug|Vorinostat|Vorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.
11992966|NCT00642954|Drug|Lenalidomide|Lenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.
11992967|NCT00642954|Drug|Dexamethasone|Dexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.
11992968|NCT00642941|Drug|RG1507|Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
11992969|NCT00642928|Drug|Placebo|1 capsule per day during 4 weeks
11992970|NCT00642928|Drug|BF 2.649 5 mg|one BF 2.649 capsule of 5 mg per day during 4 weeks
11992971|NCT00642928|Drug|BF 2.649 10 mg|One BF 2.649 capsule of 10 mg per day during 4 weeks
11992972|NCT00642928|Drug|BF 2.649 20 mg|One BF 2.649 capsule of 20 mg per day during 4 weeks
11992973|NCT00642928|Drug|BF 2.649 40 mg|One BF 2.649 capsule of 40 mg per day during 4 weeks
11992974|NCT00642915|Drug|Lantus, Amaryl|
11992975|NCT00642902|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
11992976|NCT00642902|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
11992977|NCT00642902|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
11992978|NCT00642902|Drug|Placebo matched to atacicept|Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
11992979|NCT00642889|Drug|Safinamide|
11992980|NCT00642889|Drug|Safinamide|
11992981|NCT00642889|Drug|Placebo|
11992982|NCT00642876|Device|Allograft Fusion and ATLANTIS™ Cervical Plate System|The patients that received the control treatment underwent a single level anterior cervical fusion procedure involving allograft bone and the ATLANTIS™ Cervical Plate System.
11992983|NCT00642876|Device|PRESTIGE® Cervical Disc|The PRESTIGE® Cervical Disc is a stainless steel device that was inserted into the intervertebral disc space. The device is composed of two metal plates that interface via a ball and socket mechanism permitting segmental spinal motion.
11992984|NCT00642863|Dietary Supplement|Ferrous Sulfate (liquid) + vitamins A and D|a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.) and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
11992985|NCT00642863|Dietary Supplement|vitamins A and D|a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
11992986|NCT00642863|Dietary Supplement|Ferrous sulfate (liquid)|Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
11992987|NCT00642850|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms iv monthly (starting dose)
11992988|NCT00642837|Drug|Tramadol/acetaminophen|Osteoarthritis, flexible dose depending on patients' pain relief
11992989|NCT00642837|Drug|Tramadol/acetaminophen|Post surgical neurophatic pain, flexible dose depending on patients' pain relief
11992990|NCT00642837|Drug|Tramadol/acetaminophen|Post traumatic neuropathic pain, flexible dose depending on patient pain relief
11992991|NCT00642837|Drug|Tramadol/acetaminophen|Spinal Cord Injury, flexible dose depending on patients' pain relief
11992992|NCT00642837|Drug|Tramadol/acetaminophen|Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
11992993|NCT00642837|Drug|Tramadol/acetaminophen|Diabetic Neuropathy, flexible dose depending on patients' pain relief
11992994|NCT00642837|Drug|Tramadol/acetaminophen|Post stroke pain, flexible dose depending on patients' pain relief
11992995|NCT00642837|Drug|Tramadol/acetaminophen|Low back pain, flexible dose depending on patients' pain relief
11992996|NCT00642837|Drug|Tramadol/acetaminophen|Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
11992997|NCT00642837|Drug|Tramadol/acetaminophen|Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
11992998|NCT00642824|Drug|Standard chemotherapy|As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
11992999|NCT00642824|Drug|bevacizumab [Avastin]|15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks
11993000|NCT00642811|Drug|Ticagrelor|Tablets, Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily for 2 weeks
11993001|NCT00642811|Drug|Clopidogrel|(over encapsulated) capsule, Oral, 75 mg; 600 mg loading dose followed by 75 mg once daily for 2 weeks
11993002|NCT00642811|Drug|Aspirin|Tablets, Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study
11993003|NCT00642798|Drug|sitagliptin phosphate|Sitagliptin 100mg once daily on Day 1 for single dose, and once daily on Day4-9 for multiple dose.
11993004|NCT00642772|Other|Group Physical Therapy|12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
11993005|NCT00642759|Drug|carboplatin|Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
11993006|NCT00642759|Drug|Nab-paclitaxel|Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
11993007|NCT00642759|Drug|Bevacizumab|IV infusion
11993008|NCT00642746|Drug|Erlotinib|"Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.
~Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage."
11993009|NCT00642746|Drug|Fluorouracil|Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours.
11993010|NCT00642746|Drug|Leucovorin|Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.
11993011|NCT00642746|Drug|Oxaliplatin|Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2.
11993012|NCT00642746|Drug|Irinotecan|Chemotherapy agent given intravenously at 180 mg/m2.
11993013|NCT00642733|Drug|erlotinib [Tarceva]|100mg po daily
11993014|NCT00642733|Drug|gemcitabine|1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle
11993015|NCT00642720|Drug|Pegvisomant|if the addition of 40 mg pegvisomant weekly will improve the quality of life of acromegaly patients compared to placebo weekly
11993016|NCT00642707|Drug|PRO 140 (humanized monoclonal antibody to CCR5)|
11993017|NCT00642707|Drug|Placebo Comparator|
11993018|NCT00642694|Drug|Escitalopram|Escitalopram 10 or 20mg qd based on symptoms at patient visit
11993019|NCT00642694|Drug|Ramelteon|Ramelteon 8 mg qd
11993020|NCT00642694|Other|Placebo|Matching placebo qd
11994335|NCT00633659|Drug|Hemospan (MP4OX)|250 mL of Hemospan (MP4OX)
11993021|NCT00642681|Drug|Technosphere Insulin|Technosphere® Insulin (TI) Inhalation Powder, prandial
11993022|NCT00642668|Drug|methoxy polyethylene glycol-epoetin beta|1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
11993023|NCT00642655|Drug|IVIG and Rituximab|IVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22
11993024|NCT00642642|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of 3 mm post auricular skin punch biopsies.
~Administration of 3 study treatments administered 14 ± 7 days apart."
11993025|NCT00642642|Biological|Placebo|"Collection of 3 mm post auricular skin punch biopsies.
~Administration of 3 study treatments administered 14 ± 7 days apart."
11993026|NCT00642629|Drug|STA 5326 mesylate|STA 5326 mesylate 100mg taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
11993027|NCT00642629|Drug|Placebo|Placebo taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
11993028|NCT00642616|Drug|Technosphere® Insulin|Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents
11993029|NCT00642616|Drug|Usual Care|Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin
11993030|NCT00642603|Drug|capecitabine [Xeloda]|1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
11993031|NCT00642603|Drug|capecitabine [Xeloda]|1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
11993032|NCT00642603|Drug|bevacizumab [Avastin]|5 mg/kg taken intravenously on Day 1 of each 2 week cycle
11993033|NCT00642603|Drug|oxaliplatin|85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
11993034|NCT00642603|Drug|irinotecan|135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
11993035|NCT00642577|Drug|bevacizumab [Avastin]|5mg/kg iv every 2 weeks
11993036|NCT00642577|Drug|irinotecan|125mg/m2 iv weekly for 4 weeks of each 6 week cycle
11993037|NCT00642577|Drug|leucovorin|20mg/m2 iv weekly for 4 weeks of each 6 week cycle
11993038|NCT00642577|Drug|fluorouracil|500mg/m2 iv weekly for 4 weeks of each 6 week cycle
11993039|NCT00642564|Other|Observational study in Epileptic Patients|Observation study in Epileptic Patients with Migraine and Headache
11993040|NCT00642551|Dietary Supplement|menaquinone-7|180 µg menaquinone-7 daily for three years
11993041|NCT00642551|Dietary Supplement|placebo|1 placebo capsule daily for three years
11993042|NCT00642538|Drug|MKC253 Inhalation Powder|Inhalation Powder, prandial
11993043|NCT00642538|Drug|Technosphere Inhalation Powder|Inhalation Powder, prandial
11993044|NCT00642538|Drug|subcutaneous injection|10µg Exenatide, prandial
11993045|NCT00642525|Procedure|Contrast swallow radiography, endoscopy|Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines
11993046|NCT00642512|Drug|dronabinol|10 - 20 mg
11993047|NCT00642512|Drug|ondansetron|8 - 16 mg
11993048|NCT00642512|Drug|dronabinol/ondansetron|10 - 20 mg/8 - 16 mg
11993049|NCT00642512|Drug|placebo|placebo
11993050|NCT00642499|Drug|Dronabinol|2.5 mg to 40 mg
11993051|NCT00642499|Drug|Placebo|placebo
11993052|NCT00642486|Other|Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)|portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.
11993053|NCT00642486|Other|Standard polysomnography (PSG)|laboratory-based testing
11993054|NCT00642473|Drug|Erlotinib|Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
11993055|NCT00642473|Drug|Metronidazole Actavis|Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
11993056|NCT00642473|Other|Non-active Moisturizing Cream|Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
11993057|NCT00642460|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg (patients>=30kg) or 12mg/kg (patients <30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.
11993058|NCT00642460|Drug|Placebo|iv every 2 weeks for 12 weeks
11993059|NCT00642460|Drug|Non-steroidal anti-inflammatory drugs (NSAIDs)|as prescribed
11993060|NCT00642460|Drug|methotrexate|as prescribed
11993061|NCT00642460|Drug|corticosteroids|orally, as prescribed
11993062|NCT00642447|Drug|helium:oxygen mixture|
11993063|NCT00642434|Drug|carvedilol|variable
11993064|NCT00642434|Drug|metoprolol|variable
11993065|NCT00642421|Drug|C2L-OCT-01 PR, 10 or 20 mg|The first three injections of study medication will be given at V1 (Day 1), V2 (35 days) and V3 (70 days). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
11993066|NCT00642421|Drug|C2L-OCT-01 PR, 20 mg|The first three injections of study medication will be given at V1 (Day 1), V2 (Day 35) and V3 (Day 70). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
11993067|NCT00642408|Dietary Supplement|Multiple micronutrient supplements (MMN)|Iron and folic acid: iron 60 mg and folic acid 400µg
11993068|NCT00642408|Dietary Supplement|IFA|Iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).
11993069|NCT00642395|Drug|Bortezomib|bortezomib-Melphalan
11993070|NCT00642382|Device|Agilus|Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
11994534|NCT00632138|Procedure|psychosocial assessment and care|
11993071|NCT00642382|Device|Normal saline|Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
11993072|NCT00642369|Drug|quetiapine fumarate|600-750mg/day
11993073|NCT00642369|Drug|haloperidol|6-40mg/day
11993074|NCT00642356|Drug|Carbidopa/levodopa/entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
11993075|NCT00642356|Drug|Immediate release carbidopa/levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
11993076|NCT00642343|Behavioral|Evaluation of motor proficiency skills.|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
11993077|NCT00642343|Behavioral|Evaluation of motor proficiency|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
11993078|NCT00642343|Behavioral|Evaluation of motor proficiency|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
11993079|NCT00642343|Behavioral|Evaluation of motor proficiency.|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
11993080|NCT00642330|Drug|oral ibuprofen|one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
11993081|NCT00642330|Drug|intravenous ibuprofen|one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
11993082|NCT00642317|Behavioral|Questionnaire|Questionnaire about tobacco and alcohol use, acculturation, and other related topics.
11993083|NCT00642304|Drug|methoxy polyethylene glycol-epoetin beta [C.E.R.A.]|Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
11993084|NCT00642291|Drug|Emtricitabine|emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if <30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if >=7 to <15kg; 10/2.5 mg/kg BID if >=15 to <=40 kg)
11993085|NCT00642291|Drug|Emtricitabine|emtricitabine (6 mg/kg QD, up to 200 mg QD capsule formulation or up to 240 mg QD using the oral solution) plus didanosine (240 mg/m2 up to 400 mg QD) plus efavirenz (up to 600 mg QD capsule formulation or up to 720 mg QD using the oral solution).
11993086|NCT00642278|Drug|Canagliflozin (JNJ-28431754)|One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.
11993087|NCT00642278|Drug|Sitagliptin|One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
11993088|NCT00642278|Drug|Placebo|One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
11993089|NCT00642265|Procedure|osteosynthesis|operative treatment
11993090|NCT00642265|Other|sling|conservative treatment
11993091|NCT00642252|Drug|Fluoride|Over-the-counter level of fluoride (226 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
11993092|NCT00642252|Drug|Fluoride|Over-the-counter level of fluoride (226 ppm) plus calcium (30 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
11993093|NCT00642239|Drug|placebo|placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
11993094|NCT00642239|Drug|Sodium Glycididazole|Sodium Glycididazole 700mg/m2 in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
11993095|NCT00642226|Procedure|Grid Laser|ETDRS Grid Laser
11993096|NCT00642226|Procedure|Vitrectomy and 20 mg triamcinolone|Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate
11993097|NCT00642200|Procedure|Lichtenstein hernioplasty|
11993098|NCT00642200|Procedure|Laparoscopic TEP|
11993099|NCT00642187|Drug|budesonide|
11993100|NCT00642187|Drug|Placebo|
11993101|NCT00642174|Drug|prasugrel|Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose.
11993102|NCT00642174|Drug|Clopidogrel|Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.
11993103|NCT00642161|Drug|budesonide|
11993104|NCT00642148|Drug|GW856553|Active tablet
11993105|NCT00642148|Drug|Placebo|Placebo tablet and inhaler
11993106|NCT00642148|Drug|Seretide|Active comparator inhaler
11993107|NCT00642135|Drug|Mydriasert®|Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
11993108|NCT00642135|Drug|phenylephrine and tropicamide eyedrops|Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
11993109|NCT00642122|Drug|Budesonide|0.5mg once daily
11993110|NCT00642122|Drug|Budesonide|1mg once daily
11993111|NCT00642122|Drug|Budesonide|1mg twice daily
11993112|NCT00642122|Drug|Budesonide|2mg once daily
11993113|NCT00642122|Drug|Budesonide|4.00mcg twice daily
11993114|NCT00642109|Procedure|midurethral sling procedure|quality of life, voiding dysfunction
11993115|NCT00642096|Drug|Metoprolol Succinate|
11993116|NCT00642096|Drug|Hydrochlorothiazide|
11993163|NCT00641732|Drug|TAK-442|TAK-442 40mg, tablets, orally, twice daily for up to 10 days.
11993164|NCT00641732|Drug|TAK-442|TAK-442 80 mg, tablets, orally, twice daily for up to 10 days.
11993165|NCT00641732|Drug|Enoxaparin|Enoxaparin 30 mg, syringe, subcutaneous injection, twice daily for up to 10 days.
11993166|NCT00641719|Drug|Duloxetine hydrochloride|Duloxetine 40 mg QD, PO, 1 year
11993117|NCT00642083|Device|Viabahn stent-graft|The viabahn stent-graft is a combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based delivery system. It was originally designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. This device is also increasingly used for the exclusion of popliteal aneurysms. Its flexibility might make the device ideal for the treatment of recurrent outflow stenosis in AV loop-fistula.
11993118|NCT00642057|Drug|tetrabenazine|25 mg titrated to optimal dose per patient
11993119|NCT00642044|Procedure|Corneal Collagen Crosslinking|UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
11993120|NCT00642031|Drug|Triciribine|15 mg/m^2 IV Weekly Over 1 Hour On Days 1, 8, and 15.
11993121|NCT00642018|Drug|docetaxel|Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
11993122|NCT00642018|Drug|LY2181308 sodium|LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
11993123|NCT00642018|Drug|Prednisone|Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
11993124|NCT00642005|Procedure|Fisher and Paykel Humidifier (MR860)|Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation.
11993125|NCT00642005|Procedure|Standard insufflation|No humidifier or warmer will be used (device switched off). This will deliver laparoscopic insufflate at 0% humidity and 20 degrees C.
11993126|NCT00641979|Drug|budesonide|Current product
11993127|NCT00641979|Device|Budesonide|New type device
11993128|NCT00641979|Drug|Placebo|
11993129|NCT00641953|Drug|IMX-150|(0.3%) 0.5g topically BID to each foot for 4 weeks
11993130|NCT00641953|Drug|IMX-150|(0.6%) 0.5g topically BID to each foot for 4 weeks
11993131|NCT00641953|Drug|Placebo|0.5 g topically BID to each foot for 4 weeks
11993132|NCT00641940|Behavioral|Girls in Transition (GT) program|In the 11-session after-school GT program, girls learn cognitive and behavioral skills related to intrapersonal, interpersonal, and social/contextual risk factors for depression.
11993133|NCT00641940|Behavioral|Waitlist Control|Participants in the waitlist control group will complete the GT program during the third year of the study.
11993134|NCT00641927|Drug|Venlafaxine|37.5 mg - 375 mg daily, 12 Weeks
11993135|NCT00641927|Drug|Lithium Carbonate|300 mg - 2100 mg daily, 12 weeks
11993136|NCT00641914|Drug|budesonide|
11993137|NCT00641914|Drug|Placebo|
11993138|NCT00641901|Behavioral|counseling|"The 8-week study includes 3 visits to the dental facility at the Center for Women's Reproductive Health at UAB. Study visits are scheduled to coincide with pre-natal visits in the same facility.
~Each visit will include individually tailored one-to-one discussion with a dental professional coupled with a demonstration and instructions for using oral hygiene products. Home-care kits will be dispensed, to include a helpful digital video disk (DVD), a high-tech powered toothbrush, dental floss, toothpaste and alcohol-free mouth rinse and subjects will have their teeth professionally cleaned.
~First and final visits will include collection of gingival crevicular fluid and blood samples and subjects will complete pre and post study questionnaires."
11993139|NCT00641875|Procedure|Nocturnal Hemodialysis|
11993140|NCT00641862|Dietary Supplement|Vitamin B12|Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery
11993141|NCT00641862|Other|Placebo|Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
11993142|NCT00641849|Behavioral|Group A|Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
11993143|NCT00641849|Behavioral|Group B|Maximum Intervention Group B will fill out data forms at zero (0), one (1), two (2), three (3), four (4), five (5), and six (6) months.
11993144|NCT00641836|Procedure|Transplantation of autologous endothelial progenitor cells|
11993145|NCT00641810|Behavioral|Caffeine reduction|Reduction in daily caffeine consumption from usual amounts to none.
11993146|NCT00641797|Drug|Meclizine|medication administration 25mg PO one time
11993147|NCT00641797|Other|Epley Maneuver|Patient has vestibular rehabilitation utilizing the Epley Maneuver.
11993148|NCT00641797|Drug|Lorazepam|Lorazepam 1 - 5mg PO/IV prn
11993149|NCT00641797|Drug|Diphenhydramine|25 - 50mg PO/IV once prn
11993150|NCT00641797|Drug|Ondansetron|Ondansetron 4 - 8 mg PO/IV prn
11993151|NCT00641784|Drug|Magnesium|Intravenous Magnesium 6 gram load, 3 grams/hr
11993152|NCT00641784|Drug|Nifedlipine|Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
11993153|NCT00641771|Drug|alendronate sodium (+) cholecalciferol|MK0217A, a tablet containing alendronate 70-mg and vitamin D3 2800 IU, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.
11993154|NCT00641771|Drug|Comparator: Placebo (unspecified)|MK0217A, Pbo tablet, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.
11993155|NCT00641758|Drug|Pycnogenol|Pycnogenol 100mg twice daily
11993156|NCT00641758|Drug|Placebo|Placebo 100mg twice daily
11993157|NCT00641745|Drug|Lurasidone HCl|40 - 120mg per day
11993158|NCT00641745|Drug|Risperidone|Risperidone
11993159|NCT00641732|Drug|TAK-442|TAK-442 40 mg, tablets, orally, once daily for up to 10 days.
11993160|NCT00641732|Drug|TAK-442|TAK-442 80 mg, tablets, orally, once daily for up to 10 days.
11993161|NCT00641732|Drug|TAK-442|TAK-442 10 mg, tablets, orally, twice daily for up to 10 days.
11993162|NCT00641732|Drug|TAK-442|TAK-442 20 mg, tablets, orally, twice daily for up to 10 days.
11993167|NCT00641719|Drug|Duloxetine hydrochloride|Duloxetine 60 mg QD, PO, 1 year
11993168|NCT00641706|Drug|vorinostat|Given orally
11993169|NCT00641706|Procedure|therapeutic conventional surgery|Patient undergoes surgery
11993170|NCT00641706|Drug|bortezomib|Given IV
11993171|NCT00641693|Drug|Budesonide|16mg Nasal Spray
11993172|NCT00641693|Drug|Budesonide|32mg Nasal Spray
11993173|NCT00641693|Drug|Budesonide|64mg Nasal Spray
11993174|NCT00641693|Drug|Placebo|
11993175|NCT00641680|Drug|Budesonide|
11993176|NCT00641680|Drug|Fluticasone propionate|
11993177|NCT00641680|Drug|Placebo|
11993178|NCT00641667|Drug|Fentanyl|Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).
11993179|NCT00641654|Drug|Pegylated interferon alfa-2a and ribavirin|Arm A: Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
11993180|NCT00641654|Drug|Pegylated interferon alfa-2a and ribavirin|Arm B:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
11993181|NCT00641654|Drug|Pegylated interferon alfa-2a and ribavirin|Arm C:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 24 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 24 weeks
11993182|NCT00641641|Drug|Tenofovir + emtricitabine + raltegravir.|TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.
11993183|NCT00641628|Procedure|mastectomy|
11993184|NCT00641615|Biological|RNF43-721|Doses of 0.5mg, 1.0mg, 3.0mg/body/week
11993185|NCT00641602|Drug|Esomeprazole|40mg once daily
11993186|NCT00641602|Drug|Lansoprazole|30mg once daily
11993187|NCT00641589|Drug|epoetin alfa|
11993188|NCT00641576|Device|ACE CONNECT Endosseous dental implant|"Subjects in this study receive ACE CONNECT Internal-Connection dental implants to: 1)replace a missing tooth in an edentulous area of the maxilla or mandible restored with a single-unit crown (may include up to two non-adjacent areas as study sites) or, 2)subjects with an edentulous mandible will receive two implants placed in the lower canine position and restored with an implant-retained removable over-denture.
~Subjects will return for four follow-up evaluations scheduled at 6, 12, 18 and 24 months after delivery of the permanent restoration."
11993189|NCT00641563|Drug|Dexmedetomidine|Infusion of dexmedetomidine
11993190|NCT00641563|Drug|Midazolam|Midazolam infusion
11993191|NCT00641563|Drug|Remifentanil|Infusion of remifentanil
11993192|NCT00641550|Other|Physical exercise|Walking 3 times a week during 1 hours (moderate activity)
11993193|NCT00641537|Drug|Cladribine|Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
11993194|NCT00641537|Drug|Placebo|Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
11993195|NCT00641537|Drug|Cladribine|Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
11993196|NCT00641537|Drug|Cladribine|Participants who received placebo in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
11993197|NCT00641537|Drug|Placebo|Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
11993198|NCT00641524|Procedure|Phlebotomy|Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level
11993199|NCT00641511|Drug|SYN117 (nepicastat)|120 mg per day
11993200|NCT00641511|Drug|Placebo comparator|once per day placebo capsules
11993201|NCT00641498|Behavioral|Psychotherapy|Individual supportive
11993202|NCT00641472|Drug|Budesonide inhalation suspension|0.5mg
11993203|NCT00641472|Drug|Montelukast Sodium|4mg or 5mg
11993204|NCT00641459|Other|Observational BPSD treatment study|Observational BPSD treatment study
11993205|NCT00641446|Drug|budesonide|
11993206|NCT00641446|Drug|varicella zoster virus|
11993207|NCT00641433|Device|oxidized regenerated cellulose collagen-silver|Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
11993208|NCT00641433|Drug|topical silver sulfadiazine cream|Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
11993209|NCT00641420|Procedure|Fractionated Laser Resurfacing|
11993210|NCT00641407|Drug|NPL insulin|Starting dose 10 IU bedtime and then titration
11993211|NCT00641407|Drug|Insulin glargine|10 IU bedtime and then titration
11993212|NCT00641394|Behavioral|Psychotherapy: Emotional Freedom Techniques (EFT)|A form of therapy that includes cognitive reframing with somatic reinforcement through touch or tapping of specified points on the body
11993213|NCT00641394|Behavioral|Cognitive Behavioral Therapy (CBT)|A form of therapy that focuses on negative cognitions of problems, and reframing them in positive terms, but without somatic reinforcement.
11993214|NCT00641381|Drug|carmustine|150 mg/m2 day -7, -6,and -5 prior to stem cell reinfusion
11993215|NCT00641381|Drug|cyclophosphamide|100 mg/kg on day -2 prior to stem cell reinfusion
11993216|NCT00641381|Drug|etoposide|60 mg/kg on day -4 prior to stem cell reinfusion
11993217|NCT00641381|Other|pharmacological study|Prior to start of etoposide infusion, 2 hours after start of infusion, just prior to the end of infusion, then at 0.5, 1, 2, 4, 24 and 48 hours after the end of infusion
11993218|NCT00641381|Procedure|autologous hematopoietic stem cell transplantation|Reinfusion of autologous stem cells
11993219|NCT00641381|Procedure|peripheral blood stem cell transplantation|Reinfusion of autologous stem cells
11993220|NCT00641368|Behavioral|R4Power Program|In the 10-lesson online R4Power Program, adolescents will learn cognitive skills (link between thoughts, feelings, and behaviors; thinking traps; challenging negative beliefs) and problem-solving skills (assertiveness; relaxation and distraction; overcoming procrastination; decision-making) in order to cope with stressful situations.
11993221|NCT00641368|Other|Waitlist Control|Adolescents in the waitlist control group will complete the R4Power program during the second year of the study.
11993222|NCT00641355|Procedure|No intervention|No intervention
11993223|NCT00641342|Device|onlay mesh|StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
11993224|NCT00641329|Drug|CLONICEL (clonidine HCl sustained release)|Flexible Dose (0.1 - 0.4 mg)
11993225|NCT00641329|Drug|Placebo|Matching placebo tablets
11993226|NCT00641316|Procedure|AtraumaticTeeth Extraction|Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
11993227|NCT00641316|Procedure|Atraumatic Teeth Extraction/Grafted Extraction Sockets|Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
11993228|NCT00641316|Procedure|Atraumatic Teeth Extraction/Grafted Extraction Sockets|Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
11993229|NCT00641316|Procedure|Atraumatic Teeth Extraction/Grafted Extraction Sockets|Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
11993230|NCT00641303|Procedure|acupuncture therapy|Given weekly for 8 sessions
11993231|NCT00641303|Procedure|sham intervention|Given weekly for 8 sessions
11993232|NCT00641290|Device|Vigileo FloTrac Sensor|Comparing the Vigileo FloTrac against the conventional Pulmonary Artery Catheter using the thermodilution method for measurements of cardiac output.
11993233|NCT00641264|Drug|Omeprazole|
11993234|NCT00641264|Behavioral|Quality of Life questionnaire|
11993235|NCT00641251|Other|intensive medical management|IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment consistent with standard of care for diabetes and other CVD risk factors.
11993236|NCT00641251|Other|RYGB & IMM|Roux-en-Y gastric bypass Surgery combined with intensive medical management
11993237|NCT00641238|Device|Radiofrequency ablation|Radiofrequency ablation
11993238|NCT00641225|Drug|SBI-087|Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.
11993239|NCT00641212|Drug|Budesonide|
11993240|NCT00641212|Drug|Placebo|
11993241|NCT00641199|Other|Jarro-Dophilus EPS probiotics|Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.
11993242|NCT00641186|Drug|sodium oxybate|4.5 to 9.0 grams per night
11993243|NCT00641173|Drug|paroxetine|treatment with SSRI paroxetine
11993244|NCT00641173|Drug|placebo|treatment with placebo
11993245|NCT00641160|Drug|vinorelbine tartrate|Dose Level #1 PO for at least 7 days
11993246|NCT00641160|Drug|vinorelbine tartrate|Dose Level #2 PO for at least 7 days
11993247|NCT00641160|Drug|vinorelbine tartrate|Dose Level #3 PO for at least 7 days
11993248|NCT00641147|Drug|Curcumin|Given PO
11993249|NCT00641147|Other|Laboratory Biomarker Analysis|Correlative studies
11993250|NCT00641147|Other|Placebo|Given PO
11993251|NCT00641134|Other|A: Home-Based exercise after Cardiac Rehabilitation|Home-Based exercise program,after CR, with reinforcement sessions
11993252|NCT00641108|Drug|ADAM SPECT plus Cognitive Therapy|
11993253|NCT00641108|Drug|ADAM SPECT plus No Therapy|
11993254|NCT00641095|Biological|rituximab|concentrate for solution for infusion
11993255|NCT00641095|Drug|Cyclophosphamide|Tablets
11993256|NCT00641095|Drug|Fludarabine|Film coated tablet
11993257|NCT00641082|Drug|Clevudine|30mg for 48 weeks
11993258|NCT00641082|Drug|Adefovir dipivoxil|10mg for 48 weeks
11993259|NCT00641069|Device|Automated load-distributing band device|Blood pressure recording before and after starting up the automated band device
11993260|NCT00641056|Drug|Exenatide Once Weekly|subcutaneous injection, 2.0mcg, once weekly
11993261|NCT00641056|Drug|Insulin Glargine|subcutaneous injection, variable dose, QD
11993262|NCT00641043|Drug|placebo + pioglitazone (30 mg)|placebo + overcapsulated 30 mg tablet, once daily
11993263|NCT00641043|Drug|Linagliptin + pioglitazone (30 mg)|5 mg tablet + overcapsulated 30 mg tablet, once daily
11993264|NCT00641030|Drug|clofarabine|Administered at the appropriate dose level(dose level one = 30 mg/m2, dose level two and three = 40 mg/m2)on days -9 to day -5 from transplant
11993265|NCT00641030|Drug|melphalan|Administered at the appropriate dose level (dose level one and two = 100 mg/m2, dose level three = 140 mg/m2) on day -4 from transplant
11993266|NCT00641030|Genetic|gene expression analysis|Peripheral blood draw on day -9 and day -4 prior to transplant
11993267|NCT00641030|Genetic|reverse transcriptase-polymerase chain reaction|Peripheral blood draw on day -9 and day -4 prior to transplant
11993268|NCT00641030|Other|flow cytometry|Bone marrow aspirate and biopsy to confirm diagnosis prior to transplant, day -9 pre-transplant, day 30 post-transplant, day 100 post-transplant, 6 months post-transplant, one year post-transplant, then yearly through year 5 post-transplant
11993269|NCT00641030|Other|laboratory biomarker analysis|Peripheral blood draw day -9 or earlier pre-transplant, day 14 post-transplant, day 30 post-transplant, day 60 post-transplant, day 100 post-transplant, 6 months and one year post-transplant.
11993270|NCT00641030|Procedure|allogeneic hematopoietic stem cell transplantation|Infusion of allogeneic hematopoietic stem cells on day 0 of transplant
11993271|NCT00641017|Biological|rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine|Live attenuated Human Parainfluenza Type 1 Virus Vaccine
11993272|NCT00641017|Biological|Placebo|Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine
11993273|NCT00641004|Drug|Rebamipide and Esomeprazole|"Rebamipide 100mg TID for 12 weeks
~Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks"
11993274|NCT00640991|Drug|glulisine insulin, glargine insulin|IV infusion of glulisine, SC injection of glargine
11993275|NCT00640978|Drug|RAD001|30 mg orally weekly for 4 weeks
11993276|NCT00640978|Drug|Erlotinib|150 mg by mouth daily for 28 Days
11993277|NCT00640965|Drug|DP-VPA|DP-VPA dose escalation to 900mg, then continued for 8 weeks
11993278|NCT00640965|Drug|DP-VPA Placebo|Matching Placebo to Active, dose escalation, then continued for 8 weeks
11993279|NCT00640952|Drug|acamprosate|333 mg 2 tabs tid
11993280|NCT00640939|Drug|diclofenac sodium|15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
11993281|NCT00640939|Drug|Matching Placebo|Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
11993282|NCT00640926|Drug|Radezolid|300 mg/day, orally for 7-10 days
11993283|NCT00640926|Drug|Radezolid|450 mg/day orally for 7-10 days
11993284|NCT00640926|Drug|Radezolid|900 mg/day orally for 7-10 days
11993285|NCT00640913|Procedure|Reversal of defunctioning stoma|Reversal of defunctioning stoma
11993286|NCT00640900|Behavioral|Usual care|Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.
11993287|NCT00640900|Behavioral|Commercial weight loss program|Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.
11993288|NCT00640887|Drug|rifabutin in combination with efavirenz|"Ia. arm 1a:
~D4T/3TC/EFV(600mg)+INH/Rifabutin(450 mg OD 4 wks switch to 600 mg OD 4 wks);
~Ib. arm 1b:
~D4T/3TC/EFV(600mg)+INH/Rifabutin(600 mg OD 4 wks switch to 450 mg OD 4 wks);"
11993289|NCT00640887|Drug|rifabutin in combination with nevirapine|"IIa. arm 2a:
~D4T/3TC/NVP(200mg)+INH/Rifabutin(300 mg OD 4 wks switch to 450 mg OD 4 wks);
~IIb. arm 2b :
~D4T/3TC/NVP(200mg)+INH/Rifabutin(450 mg OD 4 wks switch to 300 mg OD 4 wks);"
11993290|NCT00640887|Drug|rifabutin in combination with lopinavir/ritonavir|"IIIa. arm 3a :
~D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg TPW 4 wks switch to 150 mg OD 4 wks);
~IIIb. arm 3b:
~D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg OD 4 wks switch to 150 mg TPW 4 wks)."
11993291|NCT00640861|Biological|CpG oligodeoxynucleotide|
11993292|NCT00640861|Biological|HER-2/neu peptide vaccine|
11993293|NCT00640861|Biological|MUC-1 peptide vaccine|
11993294|NCT00640861|Biological|incomplete Freund's adjuvant|
11993295|NCT00640861|Biological|sargramostim|
11993296|NCT00640861|Other|immunoenzyme technique|
11993297|NCT00640861|Other|immunologic technique|
11993298|NCT00640848|Drug|almorexant|1 dose of 400 mg in two treatment sequences
11993299|NCT00640848|Drug|almorexant|1 dose of 200 mg in two treatment sequences
11993300|NCT00640848|Drug|almorexant|1 dose of 100 mg in two treatment sequences
11993301|NCT00640848|Drug|almorexant|1 dose of 50 mg mg in two treatment sequences
11993302|NCT00640848|Drug|almorexant|1 dose of 1000 mg in two treatment sequences
11993303|NCT00640835|Drug|Buprenorphine/naloxone Film Strip|Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route
11993304|NCT00640835|Drug|Buprenorphine/naloxone Film Strip|Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route
11993305|NCT00640822|Drug|Calcipotriol plus hydrocortisone ointment vehicle|Once daily application for up to 8 weeks
11993306|NCT00640822|Drug|Tacalcitol Ointment|Once daily application for up to 8 weeks
11993307|NCT00640822|Drug|Calcipotriol plus hydrocortisone ointment|Once daily application for up to 8 weeks
11993308|NCT00640809|Drug|Celecoxib|200 mg oral capsule twice daily for 2 weeks
11993309|NCT00640809|Other|Placebo|Matched placebo for 2 weeks
11993310|NCT00640809|Drug|Ibuprofen plus Omeprazole|ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks
11993311|NCT00640796|Procedure|Haploidentical donor derived natural killer cell infusion|Therapeutic cell infusion
11993312|NCT00640796|Drug|Chemotherapy|Cyclophosphamide, Fludarabine, Interleukin-2, Mesna
11993313|NCT00640796|Device|CliniMACS|Cell selection system based on magnetic-activated cell sorting
11993314|NCT00640783|Behavioral|Mediterranean diet|The dietary advice was tailored to each patient on the basis of 3-day food records. The recommended composition of the dietary regimen was as follows: carbohydrates, 50% to 60%; proteins, 15% to 20%; total fat, less than 30%; saturated fat, less than 10%; and cholesterol consumption, less than 300 mg per day. Moreover, patients were advised to consume at least 250 to 300 g of fruits, 125 to 150 g of vegetables, and 25 to 50 g of walnuts per day; in addition, they were also encouraged to consume 400 g of whole grains (legumes, rice, maize, and wheat) daily and to increase their consumption of olive oil.
11993315|NCT00640783|Behavioral|Control|Patients consuming the control diet were given general oral and written information about healthy food choices at baseline and at subsequent visits but were offered no specific individualized program. However, the general recommendation for macronutrient composition of the diet was similar to that for the intervention group (carbohydrates, 50%-60%; proteins, 15%-20%; and total fat, <30%).
11993316|NCT00640770|Device|balloon angioplasty|balloon angioplasty
11993317|NCT00640770|Device|drug eluting stent|Cypher Select+ Coronary or Infrapopliteal Stent
11993318|NCT00640757|Dietary Supplement|Methionine deficient diet|Hominex with a low protein diet
11993319|NCT00640757|Dietary Supplement|Methionine sufficient diet|Hominex, low protein diet and methionine capsules
11993320|NCT00640744|Drug|Atorvastatin|Atorvastatin 80 mg tablet/day for 3 months
11993321|NCT00640731|Device|OmniWave Endovascular System|Treatment with mechanical thrombolysis/thrombectomy
11993322|NCT00640705|Drug|diclofenac sodium|15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
11993323|NCT00640705|Drug|Matching placebo patch|Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
11994535|NCT00632138|Procedure|quality-of-life assessment|
11993324|NCT00640679|Drug|Abrupt Clopidogrel Interruption|Patients assigned to this group will receive Clopidogrel 75mg per day for an additional period of 4 weeks. Afterwards they will stop the drug abruptly.
11993325|NCT00640679|Drug|Clopidogrel Tapering|Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.
11993326|NCT00640666|Behavioral|Exercise Behavior Change|Multidisciplinary
11993327|NCT00640653|Behavioral|Abstinence-only HIV/STD risk-reduction intervention|Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use.
11993328|NCT00640653|Behavioral|Safer-sex-only HIV/STD risk-reduction intervention|Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence.
11993329|NCT00640653|Behavioral|Long comprehensive HIV/STD risk-reduction intervention|Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours).
11993330|NCT00640653|Behavioral|Short comprehensive HIV/STD risk-reduction intervention|Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active.
11993331|NCT00640653|Behavioral|Health promotion control intervention|"Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
11993332|NCT00640640|Device|Pascal Dynamic Contour Tonometer|Pascal Dynamic Contour Tonometer is an ocular device that is able to safely measure the intraocular pressure and the ocular pulse amplitude
11993333|NCT00640640|Drug|Ranibizumab|measure the effect of intravitreal 0.5mg/0.05ml ranibizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer
11993334|NCT00640640|Drug|Bevacizumab|measure the effect of intravitreal 1.25mg/0.05ml bevacizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer
11993335|NCT00640627|Drug|Celecoxib|200 mg oral capsule once daily for 6 weeks
11993336|NCT00640627|Drug|Placebo|Matched oral placebo for 6 weeks
11993337|NCT00640614|Biological|T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens|"Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP
~Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours."
11993338|NCT00640601|Drug|Quetiapine Fumarate Extended- Release|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
11993339|NCT00640588|Drug|Telbivudine|Arm 1: 600 mg/day, oral telbivudina for 24 weeks
11993340|NCT00640588|Drug|oral adefovir|Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
11993341|NCT00640575|Drug|triamcinolone and lidocaine hydrochloride|Ultrasound-guided lidocaine hydrochloride 5 ml (10 mg/ml) injection in the subacromial bursa and a triamcinolone 2 ml (10 mg/ml) and 2 ml lidocaine hydrochloride (10 mg/ml) intramuscular injection in the gluteal region
11993342|NCT00640575|Drug|triamcinolone and lidocaine hydrochloride|Ultrasound-guided injection of 2 ml triamcinolone (10 mg/ml) and 5 ml lidocaine hydrochloride (10 mg/ml) in the subacromial bursa and 4 ml intramuscular injection of lidocaine hydrochloride in the gluteal region
11993343|NCT00640562|Drug|Quetiapine Extended Release|Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
11993344|NCT00640562|Drug|Risperidone|Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
11993345|NCT00640549|Drug|Atorvastatin|After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the atorvastatin group were treated with atorvastatin 20 mg tablets administered once daily orally for 8 weeks.
11993346|NCT00640549|Drug|Placebo|After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the placebo group were treated with placebo 20 mg tablets administered once daily orally for 8 weeks.
11993347|NCT00640523|Drug|forodesine HCl|2 x 100mg capsules daily
11993467|NCT00639717|Drug|methoxsalen|"Methoxsalen (UVADEX) treatments by Extracorporeal photopheresis (ECP) will be started day +28 post transplant and given weekly.
~On day +70 post transplant ECP frequency will be given every other week.
~On day +100 post transplant ECP will be given monthly until day +180 and stopped."
11993468|NCT00639691|Biological|omalizumab|sc
11993348|NCT00640510|Drug|Rapid Acting Intramuscular Olanzapine|10mg/injection, IM. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
11993349|NCT00640510|Drug|Isotonic sodium chloride solution|0.9% sodium chloride (NaCl) solution. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
11993350|NCT00640497|Biological|IT-Combination|The treatment consists of a standard dose of 4 infusions of IT-combination (4 mg/m2), given 48-hours apart over a 4-hour period. The IT-combination is a combination of two immunotoxins. One immunotoxin is a mAb anti-CD3 conjugated to recombinant ricin A chain and the other immunotoxin is a mAb anti-CD7 conjugated to recombinant ricin A chain.
11993351|NCT00640484|Drug|carmoterol (CHF 4226)|"carmoterol (CHF 4226) 2 μg once a day, in the morning
~(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)"
11993352|NCT00640484|Drug|carmoterol (CHF 4226)|"carmoterol (CHF 4226) 4 μg once a day, in the morning
~(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)"
11993353|NCT00640484|Drug|placebo|"placebo once a day, in the morning
~(1 puff of placebo pMDI + 1 puff of placebo pMDI)"
11993354|NCT00640484|Drug|salmeterol|"Salmeterol 50 μg twice daily, in the morning and in the evening
~(1 blister of Serevent Diskus BID)"
11993355|NCT00640471|Biological|cetuximab|cetuximab (Erbitux®) - Initial dose - Day 1 (Week 1): 400 mg/m2 IV over 120 minutes Maintenance Infusions (subsequent weeks): 250 mg/m2 IV over 60 minutes
11993356|NCT00640471|Drug|brivanib alaninate|brivanib (BMS-582664) 800 mg po, QD
11993357|NCT00640458|Drug|Sildenafil 100 mg|
11993358|NCT00640458|Drug|Placebo|
11993359|NCT00640445|Behavioral|Expressive Writing|In EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event for 20 minutes a day for 4 days
11993360|NCT00640445|Behavioral|Control Writing|Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.
11993361|NCT00640432|Drug|Diclofenac|75 mg oral capsule twice daily for 7 days
11993362|NCT00640432|Drug|Celecoxib|400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
11993363|NCT00640419|Drug|ABT-089|Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
11993364|NCT00640419|Drug|placebo|Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.
11993365|NCT00640406|Device|Dynamic Renal Stent plus Best Medical Treatment|percutaneous transluminal angioplasty of the kidney artery at index procedure followed by best medical treatment for hypertension secondary to renal artery stenosis according to local standards
11993366|NCT00640406|Drug|Best Medical Treatment|best medical treatment for hypertension secondary to renal artery stenosis according to local standards
11993367|NCT00640393|Drug|Etanercept|Etanercept 50 mg, subcutaneous (SC) injection.
11993368|NCT00640393|Device|nbUVB|
11993369|NCT00640380|Other|Nerve stimulation|CPVB with NS
11993370|NCT00640380|Other|Loss of resistance to air|CPVB with LOR
11993371|NCT00640367|Other|Alteplase IA and/or mechanical thrombolysis|loca intra-arterial recombinant tissue plasminogen activator and/or mechanical thrombolysis
11993372|NCT00640367|Drug|Alteplase IV|intravenous recombinant tissue plasminogen activator
11993373|NCT00640354|Device|Automated external defibrillator|Residents randomized to this group had an automated external defibrillator available for the simulated cardiac arrest. The automated external defibrillator did not actually discharge energy into the simulated patient
11993374|NCT00640354|Device|Manual defibrillator|Residents randomized to this group had a manual defibrillator available for the simulated cardiac arrest. The defibrillator did not actually discharge energy into the simulated patient.
11993375|NCT00640341|Device|PureVision Contact Lens|contact lens for daily wear
11993376|NCT00640341|Device|Acuvue Oasys Contact Lens|contact lens for daily wear
11993377|NCT00640341|Device|O2Optix Contact lens|contact lens for daily wear
11993378|NCT00640328|Drug|Ofatumumab 100|100mg
11993379|NCT00640328|Drug|Ofatumumab 300|300mg
11993380|NCT00640328|Drug|Ofatumumab 700|700mg
11993381|NCT00640328|Drug|Placebo|matching placebo
11993382|NCT00640315|Drug|Riociguat (Adempas, BAY63-2521) 1.0 mg|1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).
11993383|NCT00640315|Drug|Riociguat (Adempas, BAY63-2521) 2.5 mg|2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).
11993384|NCT00640289|Drug|Fibrogammin P|Prophylaxis treatment
11993385|NCT00640276|Drug|pitavastatin|Pitavastatin 2mg daily once
11993386|NCT00640276|Behavioral|Lifestyle Modification|conducting mainly exercises and diet
11993387|NCT00640263|Drug|lopinavir/ritonavir (LPV/r)|Oral liquid formulation lopinavir/ritonavir(80 mg lopinavir + 20 mg ritonavir/mL); Dosing : 40/10mg twice daily if infant weight is between 2 to 4 kg and 80/20mg twice daily if infant weight is above 4kg The lopinavir/ritonavir will be given to the baby from Day 7 postnatal until 4 weeks after the cessation of breastfeeding. During the treatment period, dosing will be adapted according to the infant weight.
11993388|NCT00640263|Drug|Lamivudine (3TC)|"Oral liquid solution lamivudine(10 mg/mL). Dosing : 7,5 mg twice daily if if infant weight is between 2 to 4 kg ; 25 mg twice daily if infant weight is between 4 to 8 kg ; 50 mg twice daily if infant weight is above 8kg.
~The lamivudine will be given to the baby from Day 7 postnatal until 4 weeks after the cessation of breastfeeding. During the treatment period, dosing will be adapted according to the infant weight."
11993469|NCT00639678|Drug|placebo|40 mg/kg intravenously, double dose (day 0 and 14), Group 3
11994585|NCT00631696|Drug|Placebo|Placebo
11993389|NCT00640250|Biological|T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens|"Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2
~Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours."
11993390|NCT00640237|Dietary Supplement|Alpha-D3|We will use the vitamin alpha-D3 drops of CTS pharmaceutical firm , that contains 5000 IU in ml. Every patient in the interventional group will receive two dose of 100000 IU (20 ml)vitamin alpha-D3 within a month period.
11993391|NCT00640224|Drug|rosiglitazone|4 mg daily for 6 months
11993392|NCT00640224|Drug|drospirenone/ethinyl estradiol|1 tab (3mg/30mcg) daily for 6 months
11993393|NCT00640198|Drug|memantine|Memantine was titrated in 5-mg weekly increments as recommended,from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24)
11993394|NCT00640198|Behavioral|constraint-induced language therapy (CIAT)|CIAT is an intensive form of language-action therapy for aphasia performed in a small group setting. In a therapeutic game context, participants had to request objects or cards from each other and understand requests made by others. Feedback of communicative success was regularly given, along with guidance, help and reinforcement. Gesturing replacing verbal language was discouraged although gestures accompanying speech were allowed. Difficulty levels were adjusted to the patients´ communicative abilities by choosing language materials and actions and reinforcement was administered taking into account each patient´s level of performance. Communication rules were introduced by shaping and modelling. Each patient received 30 hours of therapy.
11993395|NCT00640198|Drug|memantine|Memantine was titrated in 5-mg weekly increments as recommended, from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24).
11993396|NCT00640198|Drug|placebo|Placebo
11993397|NCT00640185|Drug|ABT-089|Subjects will take up to two 40 mg tablets once daily for 8 weeks.
11993398|NCT00640185|Drug|Placebo|Subjects will take one or two placebos once daily for the duration of the study.
11993399|NCT00640159|Drug|Zelapar|Switch from oral selegiline to Zelapar 1.25 mg QD titrated to 2.5 mg QD
11993400|NCT00640146|Drug|Methylnaltrexone bromide|Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
11993401|NCT00640146|Drug|Placebo|Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
11993402|NCT00640133|Device|Active DBS|In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
11993403|NCT00640133|Device|Sham DBS|In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.
11993404|NCT00640120|Device|WIM-PC™ device|wheeze detection during dynamic bronchial situations in infants
11993405|NCT00640094|Drug|melatonin|Patients will receive a total intravenous melatonin dose of 12 mg + intracoronary melatonin dose of 2 mg. The intravenous dose will be distributed in a volume of 50 ml of a isotonic and sterile solution and administered by intravenous infusion during 60 minutes. The intracoronary dose will be distributed in a volume of 10 ml of a isotonic and sterile solution and administered as a bolus.
11993406|NCT00640081|Biological|cetuximab|
11993407|NCT00640081|Drug|capecitabine|
11993408|NCT00640081|Drug|fluorouracil|
11993409|NCT00640081|Drug|leucovorin calcium|
11993410|NCT00640081|Drug|oxaliplatin|
11993411|NCT00640081|Other|immunohistochemistry staining method|
11993412|NCT00640081|Other|laboratory biomarker analysis|
11993413|NCT00640055|Other|Coordinator|Coordinator (non-physician) assigned cause of death
11993414|NCT00640055|Other|Physician-assigned cause of death|Physician (gold standard) cause of death
11993415|NCT00640042|Drug|morphine sulfate extended release capsules|30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.
11993416|NCT00640029|Procedure|Arthrodesis|"posterior,
~anterior,
~circumference approach"
11993417|NCT00640029|Device|Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)|"SYNTHES : PRODISC-C® , PRODISC-L®
~LDR : Mobi-C®, Mobidisc®
~MEDTRONIC : PrestigeLP®, A-Mav®, O-Mav®
~SCIENT'X : DISCOCERV®"
11993418|NCT00640016|Other|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
11993419|NCT00640016|Biological|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
11993420|NCT00640016|Biological|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
11993421|NCT00640016|Other|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
11993470|NCT00639678|Drug|raxibacumab|40 mg/kg intravenously, double dose (day 0 and 14), Group 1
11993471|NCT00639678|Drug|placebo|40 mg/kg placebo, single dose (day 0), Group 4
11993472|NCT00639678|Drug|raxibacumab|40 mg/kg intravenously, single dose, day 0, Group 2
11993422|NCT00640003|Drug|Baclofen|Drug given by orally via capsules. Escalation steps in 4-day intervals. Step 1: 5mg QAM. Step 2: 5mg BID. Step 3: 5mg TID. Step 4: 10mg QAM, 5mg BID. Step 5: 10mg BID, 5mg QMid-day. Step 6: 10mg TID. Step 6 will last up to 2 weeks. De-escalation will start from highest dose step and work backwards in 2-day intervals. Complete drug administration of escalating, staying constant at 10mg TID and de-escalating will be done with both drug and placebo.
11993423|NCT00640003|Drug|Placebo|placebo drug
11993424|NCT00639990|Other|PEEP|Application of positive end expiratory pressure
11993425|NCT00639990|Other|PEEP|Application of positive end-expiratory pressure
11993426|NCT00639990|Other|PEEP|Application of positive end-expiratory pressure
11993427|NCT00639990|Other|PEEP|Application of positive end-expiratory pressure
11993428|NCT00639977|Other|Acupuncture|20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming
11993429|NCT00639977|Other|Sham|20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians
11993430|NCT00639964|Other|blood tests|3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
11993431|NCT00639964|Other|diet questionnaire|questions about nutrition before and during pregnancy
11993432|NCT00639964|Other|umbilical cord blood collect|collected at the delivery
11993433|NCT00639964|Other|placenta collect|collected at the delivery
11993434|NCT00639951|Biological|A|20 vials up front in a Single Dose of Antivipmyn
11993435|NCT00639951|Biological|Antivipmyn ®|20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
11993436|NCT00639938|Drug|Nevirapine|200 mg Nevirapine tablet
11993437|NCT00639938|Drug|HIV immune globulin solution|5% intravenous HIV immune globulin solution
11993438|NCT00639925|Biological|VEGFR1-1084, VEGFR2-169, and gemcitabine|One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8 and 15.
11993439|NCT00639912|Drug|sodium chloride|Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.
11993440|NCT00639912|Drug|sodium chloride|Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours
11993441|NCT00639912|Drug|sodium bicarbonate|154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.
11993442|NCT00639912|Drug|sodium bicarbonate|154 mEq/L of sodium chloride in dextrose solution. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours.
11993443|NCT00639899|Procedure|Sclerotherapy|Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral
11993444|NCT00639873|Drug|Artesunate|2 or 4 mg/kg/day for 7 days
11993445|NCT00639873|Drug|quinine-doxycycline|quinine-doxycycline for 7 days
11993446|NCT00639860|Device|OSSIX-Plus|resorbable collagen membrane
11993447|NCT00639847|Behavioral|In-home asthma management program (AMP) provided by nurses|The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.)
11993448|NCT00639847|Behavioral|In-home asthma management program (AMP) provided by respiratory therapists|The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.)
11993449|NCT00639834|Biological|MDX-1342|One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment.
11993450|NCT00639808|Drug|5% dextrose in water|60 ml IV infusion over 30 minutes
11993451|NCT00639808|Drug|TZP-101|1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
11993452|NCT00639795|Procedure|Thoracic Paravertebral Nerve Block|One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia
11993453|NCT00639795|Procedure|Thoracic Paravertebral Nerve Block|Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia
11993454|NCT00639782|Device|On-X Heart valve replacement|On-X Heart valve replacement
11993455|NCT00639782|Device|SJM Heart valve replacement|SJM Heart valve replacement
11993456|NCT00639769|Drug|cisplatin|Starting dose 30 mg/m2 Dose level -1 20 mg/m2
11993457|NCT00639769|Drug|irinotecan hydrochloride|50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.
11993458|NCT00639756|Drug|Allopurinol|Allopurinol 300 mg
11993459|NCT00639756|Drug|Placebo|Placebo given for 2 weeks
11993460|NCT00639743|Drug|placebo ( group B)|placebo ( group B)
11993461|NCT00639743|Drug|tenecteplase (group A)|tenecteplase (group A)
11993462|NCT00639730|Dietary Supplement|modified Atkins diet|High fat, low carbohydrate diet
11993463|NCT00639717|Procedure|stem cell transplant|reduced intensity, matched unrelated donor stem cell transplant
11993464|NCT00639717|Drug|tacrolimus (standard GVHD prophylaxis)|"Tacrolimus(or cyclosporine when necessary)
~Tacrolimus will begin on day -3, IV or oral.
~Target trough level for tacrolimus is 8-12 ng/ml.
~In the absence of GVHD, tacrolimus tapering will begin on day +56 post transplant"
11993465|NCT00639717|Drug|mycophenolate (standard GVHD prophylaxis)|Mycophenolate will begin on day 0 at 10 mg/kg/dose (up to 1 gram per dose) every 8 hours orally or intravenously and will continue until day 28.
11993466|NCT00639717|Drug|etanercept|Etanercept will be given at a dose 0.4 mg/kg (actual weight) up to a maximum dose of 25 mg, subcutaneously, twice weekly from day 0 to day 56 (16 doses)
11993473|NCT00639665|Other|Cocoa|Polyphenol rich or poor cocoa was administered to study subjects to measure hemodynamic responses and the role of nitric oxide in the renal vasodilator response.
11993474|NCT00639652|Procedure|3D-histology|The tumor is marked at the 12 o'clock-position. Excision with a safety margin between 2 and 10 mm, depending on tumor size and location. Plastic reconstruction. Removal of the specimen's margins and base as thin layers, using a scalpel. These primarily three-dimensional layers of the specimen's borders are flattened to one level and microscopically screened for tumor cells. 3D-histology is combined with representative vertical sections for histologic diagnosis. Consecutive excisions are performed topographically at the tumor-positive areas and 3D-histology is repeated until tumor-free margins are obtained.
11993475|NCT00639652|Procedure|Shave excision|Tumor removal by shave excision with a safety margin. Healing by secondary intention. Histologic diagnosis of BCC type (nodular, superficial, morpheaform, micronodular, other type, mixed type) or diagnosis of another tumor than BCC. Comment on complete removal (R0 versus R1).
11993476|NCT00639639|Biological|tetanus toxoid|Given by injection
11993477|NCT00639639|Biological|therapeutic autologous dendritic cells|Given intradermally
11993478|NCT00639639|Biological|therapeutic autologous lymphocytes|Given IV
11993479|NCT00639626|Drug|insulin detemir [rDNA origin] injection|Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
11993480|NCT00639613|Procedure|Double-balloon enteroscopy|Double-balloon enteroscopy allows for the entire gastrointestinal tract to be visualized in real time. The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is also fitted with a balloon. The procedure is usually done with the use of conscious sedation. The enteroscope and overtube are inserted through the mouth and passed in conventional fashion (that is, as with gastroscopy) into the small bowel. Following this, the endoscope is advanced a small distance in front of the overtube and the balloon at the end is inflated. Using the assistance of friction at the interface of the enteroscope and intestinal wall, the small bowel is accordioned back to the overtube. The overtube balloon is then deployed, and the enteroscope balloon is deflated. The process is then continued until the entire small bowel is visualized. Double-balloon enteroscopy allows for the sampling or biopsying of small bowel mucosa.
11993481|NCT00639613|Other|Standard meal test|"Liquid meal consisting of 100 g Ny NAN dissolved in 300 ml water (ca. 5000 kJ) to be ingested over 5 minutes. Blood will be sampled for 4 hours following ingestion. Samples are centrifuges and plasma will be analysed for glucagon, GLP-1, GIP, insulin and C-peptide concentrations."
11993482|NCT00639600|Procedure|human pancreatic islet transplantation|human pancreatic islet transplantation
11993483|NCT00639587|Drug|Ketotifen|Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
11993484|NCT00639587|Drug|Cetirizine|Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
11993485|NCT00639574|Drug|Néfopam|"There are two groups :
~a group N : néfopam
~a group P : placebo All the patients receive, before randomization, 100 mg of ketoprofen (Profenid) on 20 minutes."
11993486|NCT00639561|Dietary Supplement|10 g of fibres per day|10 g of fibres per day
11993487|NCT00639561|Dietary Supplement|40 g of fibres per day|40g of fibres per day
11993488|NCT00639522|Drug|Liposomal paclitaxel and capecitabine|Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel.
11993489|NCT00639509|Biological|cixutumumab|Given IV
11993490|NCT00639509|Procedure|computed tomography|Undergo contrast-enhanced computed tomography
11993491|NCT00639509|Procedure|contrast-enhanced magnetic resonance imaging|Undergo contrast-enhanced magnetic resonance imaging
11993492|NCT00639496|Drug|n-acetylcysteine|600 mg x 3, for 12 months
11993493|NCT00639496|Drug|placebo|Placebo
11993494|NCT00639483|Drug|Celecoxib|200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
11993495|NCT00639483|Drug|Placebo|Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
11993496|NCT00639470|Other|easy to read fact sheets|easy to read fact sheets with illustrations and without illustrations
11993497|NCT00639457|Drug|Pioglitazone|Oral 30mg/day for 16 weeks
11993498|NCT00639457|Behavioral|Exercise training|Supervised aerobic and resistance exercise training (1.5hrs/day x 3 days/wk) for 16 weeks
11993499|NCT00639444|Dietary Supplement|gluten-free, normocaloric diet from 6 to 12 months|Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet
11993500|NCT00639431|Behavioral|direct observation|direct observation of another person's foot moving
11993501|NCT00639431|Behavioral|mental visualization|mentally imagining moving one's phantom foot/feet
11993502|NCT00639418|Biological|Influenza vaccination|This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.
11993503|NCT00639392|Drug|Placebo|Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
11993504|NCT00639392|Drug|Zoledronic Acid|Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.
11993505|NCT00639379|Device|senofilcon A toric|silicone hydrogel toric lens, 2 wk replacement, daily wear
11993506|NCT00639379|Device|alphafilcon A toric|hydrogel toric lens, 2 wk replacement, daily wear
11993507|NCT00639366|Biological|trastuzumab|
11993508|NCT00639366|Drug|chemotherapy|
11993509|NCT00639366|Radiation|radiation therapy|
11993510|NCT00639353|Device|senofilcon A toric soft contact lens|contact lens
11993511|NCT00639353|Device|senofilcon A sphere soft contact lens|contact lens
11993512|NCT00639327|Drug|S-1 + irinotecan|Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
11993513|NCT00639327|Drug|irinotecan|Irinotecan 150mg/m2 iv on day one every two weeks until PD
11993514|NCT00639314|Procedure|pylorus-preserving pancreaticoduodenectomy|pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus
11993612|NCT00638638|Drug|Abciximab placebo|"Abciximab placebo Bolus
~Abciximab: 0.25 mg/Kg bolus
~Abciximab infusion 10 µg/Kg/min"
11993515|NCT00639314|Procedure|pylorus-resecting pancreaticoduodenectomy|In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.
11993516|NCT00639301|Behavioral|Questionnaires|The survey will be administered by mail or telephone interview, based upon the participant preference. The survey has been adapted from the 2008 questionnaire being administered through the CCSS (11); it has been supplemented with questions addressing areas of interest specific to the retinoblastoma survivor population (eg, validated instruments that assess visual impairment).
11993517|NCT00639288|Other|modified CPT-C|modified CPT-C
11993518|NCT00639262|Drug|Sorafenib|Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose)
11993519|NCT00639262|Drug|Temozolomide|For Cohort 2 - Gliomas only.
11993520|NCT00639262|Radiation|Radiotherapy|Radiation Therapy (XRT)
11993521|NCT00639249|Drug|placebo|Oral administration
11993522|NCT00639249|Drug|SA4503 Low|Oral administration
11993523|NCT00639249|Drug|SA4503 High|Oral administration
11993524|NCT00639236|Other|hypertonic saline|inhaled hypertonic saline (at a dose of 5 ml of a 3% solution) three times a week, combined with a program of physical exercises.
11993525|NCT00639223|Dietary Supplement|Red Yeast Rice|Four 600mg capsules twice daily for 12 weeks
11993526|NCT00639223|Drug|Pravastatin|One 20mg capsule twice daily for 12 weeks
11993527|NCT00639223|Behavioral|Lifestyle modification program|Weekly sessions each lasting 3 1/2 hours for 12 weeks
11993528|NCT00639210|Other|supervised training|Design: supervised training is organised for the exercise group once a week in groups of 10 to 15 subjects. The training is guided by an experienced physical therapist.Content: The supervised training of the exercise group consists of two different classes alternating at four week periods; step aerobics class and circuit training class. The 60-minute aerobics and circuit training classes also include warming-up and cooling-down periods both lasting 10-15 minutes.
11993529|NCT00639197|Procedure|To tunnel|Using the standard Seldinger technique and under the guidance of ultrasound, the catheter will pass through a 3-5cm subcutaneous tunnel before it is eventually secured to reside at the internal jugular vein.
11993530|NCT00639197|Procedure|Standard (not to tunnel)|Using the standard Seldinger technique and under the guidance of ultrasound, the catheter is secured to reside at the internal jugular vein, without a subcutaneous tunnel.
11993531|NCT00639184|Other|Early intervention counseling|Bi-monthly home visits by counselor
11993532|NCT00639184|Other|Health education counseling|World Health Education health education counseling program at home visits,twice per month
11993533|NCT00639158|Drug|ABT-335|135 mg capsule, daily, 12 weeks
11993534|NCT00639158|Drug|placebo|placebo capsule, daily, 12 weeks
11993535|NCT00639158|Drug|atorvastatin|40 mg, tablet, daily, 12 weeks
11993536|NCT00639158|Drug|ezetimibe|10 mg capsule, daily, 12 weeks
11993537|NCT00639119|Drug|Ropinirole|8 + 8 weeks cross-over placebo controlled
11993538|NCT00639106|Procedure|Alloderm, Questionnaires|All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.
11993539|NCT00639106|Procedure|Without ALLODERM, Questionnaires|A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.
11993540|NCT00639093|Behavioral|psychoeducational / motivational combined with crushing|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
11993541|NCT00639093|Behavioral|psychoeducational / motivational combined with control|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
11993542|NCT00639080|Other|Stop lipid lowering therapy (statin)|Subjects will only be included in the study and thus asked to stop the statin if they are taking less than or equal to 10 mg of lipitor or an equivalent of another statin.
11993543|NCT00639067|Device|Breath Collection Apparatus|Breath collected and analyzed for markers of lung cancer.
11993544|NCT00639054|Procedure|Bone marrow examination|7.5 ml of iliac crest bone marrow drawn in addition to diagnostic samples.
11993545|NCT00639054|Procedure|Blood samples|24 ml of cubital vein blood drawn in addition to diagnostic samples.
11993546|NCT00639041|Dietary Supplement|n-3 LC-PUFA|n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d
11993547|NCT00639041|Dietary Supplement|Placebo|dairy products without special oils
11993548|NCT00639028|Other|Ankle echography|Ankle echography
11993549|NCT00639028|Other|Ankle echography + stress radiography|Ankle echography + stress radiography
11993550|NCT00639028|Other|stress radiography|ankle stress radiography
11993551|NCT00639015|Drug|Phenylephrine|Titrated phenylephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
11993552|NCT00639015|Drug|Norepinephrine|Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
11993553|NCT00639002|Drug|Ruxolitinib 25 mg|Ruxolitinib was supplied as 5 and 25 mg tablets.
11993554|NCT00639002|Drug|Dexamethasone 40 mg|Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
11993555|NCT00638989|Biological|CAT-354 150 mg (intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
11993556|NCT00638989|Biological|CAT-354 150 mg (subcutaneous)|A single dose of CAT-354 150 mg injection subcutaneously on Day 0.
11993557|NCT00638989|Biological|CAT-354 300 mg (subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
11993558|NCT00638976|Drug|eptifibatide|Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure
11993559|NCT00638976|Drug|placebo|Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure
11993560|NCT00638963|Drug|temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
11993561|NCT00638950|Dietary Supplement|n-3 LC-PUFA|Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils. The daily dose of n-3 FA amounted to 2.4 g, consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA.
11993562|NCT00638950|Dietary Supplement|Placebo|The placebo products were commercial dairy products with comparable fat contents.
11993563|NCT00638937|Drug|saracatinib|Given PO
11993564|NCT00638924|Other|Shuttle walk test|the test requires patients to walk at a gradually increasing speed, up and down a 10 m course identified by two marker cones, until they reach a symptom limited maximum. The walking speed was externally paced and controlled by a series of beeps played on a compact disk.
11993565|NCT00638898|Drug|busulfan|Given IV
11993566|NCT00638898|Drug|melphalan|Given IV
11993567|NCT00638898|Drug|topotecan hydrochloride|Given IV
11993568|NCT00638898|Other|laboratory biomarker analysis|Correlative studies
11993569|NCT00638898|Biological|filgrastim|Given IV or subcutaneously
11993570|NCT00638898|Procedure|autologous hematopoietic stem cell transplantation|Undergo transplantation
11993571|NCT00638898|Other|pharmacological study|Correlative studies
11993572|NCT00638898|Procedure|autologous bone marrow transplantation|Undergo transplantation
11993573|NCT00638872|Drug|Polydeoxyribonucleotide|3 times a week perilesional or intramuscular injections
11993574|NCT00638872|Other|0.9% NaCl|same as PDRN
11993575|NCT00638859|Drug|Telithromycin (HMR3647)|
11993576|NCT00638846|Device|senofilcon A toric|silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
11993577|NCT00638846|Device|balafilcon A toric|silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
11993578|NCT00638833|Drug|Memantine|Memantine 30 mg/day (20-10-0)
11993579|NCT00638833|Drug|Placebo|Placebo pills
11993580|NCT00638820|Procedure|Stem Cell or Umbilical Cord Blood Transplantation|Stem Cell (unrelated or matched related donor grafts (both peripheral blood and marrow) infusion on Day 0 and 42; Umbilical Cord Blood on Day 0 and 42
11993581|NCT00638820|Drug|Campath, Busulfan, Clofarabine|"12 Campath-1H 0.3 mg/kg intravenously (IV) over 2 hours
~11 Campath-1H 0.3 mg/kg intravenously over 2 hours
~10 Campath-1H 0.3 mg/kg intravenously over 2 hours
~9 Busulfan <12 kg: 2.2 mg/kg/dose IV every 12 hours >12 kg: 1.6 mg/kg/dose IV every 12 hours
~8 Busulfan <12 kg: 2.2 mg/kg/dose IV every 12 hours >12 kg: 1.6 mg/kg/dose IV every 12 hours
~7 Rest
~6 Clofarabine 40 mg/m2 intravenously over 2 hours
~5 Clofarabine 40 mg/m2 intravenously over 2 hours
~4 Clofarabine 40 mg/m2 intravenously over 2 hours
~3 Clofarabine 40 mg/m2 intravenously over 2 hours
~2 Clofarabine 40 mg/m2 intravenously over 2 hours"
11993582|NCT00638820|Procedure|Total Lymphoid Irradiation|Dose 500 cGy via anteroposterior (AP) and posteroanterior (PA) fields (250 cGy AP and 250 cGy PA).
11993583|NCT00638807|Drug|Celecoxib|200 mg oral capsule once daily with morning meal for 6 weeks
11993584|NCT00638807|Other|Placebo|Matched oral placebo for 6 weeks
11993585|NCT00638794|Device|Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)|PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System Xience V Everolimus Eluting Coronary Stent System
11993586|NCT00638781|Drug|Desmoteplase|Desmoteplase 62.5 µg/kg BW
11993587|NCT00638781|Drug|Desmoteplase|Desmoteplase 90 µg/kg BW
11993588|NCT00638781|Drug|Desmoteplase|Desmoteplase 125 µg/kg BW
11993589|NCT00638781|Drug|Placebo|Placebo
11993590|NCT00638768|Other|Physiotherapy|10 weekly individual sessions with the therapist each lasting approximately 45 minutes. Techniques included postural taping, massage, mobilisation, exercises. The patients also performed home exercises
11993591|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
11993592|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
11993593|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
11993594|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
11993595|NCT00638742|Drug|latanoprost|latanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.
11993596|NCT00638729|Drug|midazolam|midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
11993597|NCT00638729|Drug|clonidine|pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
11993598|NCT00638729|Drug|placebo|inert tablet p.o., 60-90 min prior to estimated induction time
11993599|NCT00638716|Drug|CJC-1134-PC|1.5 or 2.0 mg CJC-1134-PC
11993600|NCT00638716|Drug|Placebo|Placebo
11993601|NCT00638703|Biological|Oxalobacter formigenes|NLT (not less than) 10^7 CFU Oxalobacter formigenes twice daily for 24 weeks
11993602|NCT00638703|Drug|Placebo|placebo
11993603|NCT00638690|Drug|Placebo|Four tablets once daily until disease progression
11993604|NCT00638690|Drug|Abiraterone acetate|Four 250-mg tablets once daily until disease progression
11993605|NCT00638690|Drug|Prednisone/prednisolone|5 mg twice daily until disease progression
11993606|NCT00638677|Dietary Supplement|Sorbitol|Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
11993607|NCT00638677|Dietary Supplement|Xylitol + BB12|Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
11993608|NCT00638677|Dietary Supplement|Xylitol|Xylitol+BB 12 delivery with a pacifier max until 2 years
11993609|NCT00638651|Device|1064 nm Nd:YAG laser|The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy
11993610|NCT00638651|Drug|Imiquimod, 5% cream|2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month
11993611|NCT00638638|Drug|Abciximab|"Abciximab: 0.25 mg/Kg bolus
~Abciximab placebo bolus
~Abciximab infusion 10 µg/Kg/min"
11993763|NCT00637468|Procedure|Globe massage|
11993613|NCT00638612|Biological|AdV-tk|Four dose levels of AdV-tk with a fixed dose level of valacyclovir are evaluated independently in the two arms of the study due to differences in the concomitant standard of care treatments. The first AdV-tk course is given prior to surgery or radiation by CT or EUS guided injection into the tumor followed by 14 days of valacyclovir. The second AdV-tk injection is into the tumor bed at the time of surgery in Arm A or same as the first injection in Arm B again followed by 14 days of valacyclovir. The AdV-tk dose levels are: Level 1= 3x10e10 vector particles (vp), Level 2= 1x10e11 vp, Level 3= 3x10e11 vp, Level 4= 1x10e12 vp
11993614|NCT00638612|Drug|Valacyclovir|Valacyclovir caplets at a dose of 2 grams orally three times per day is administered for 14 days starting 1-3 days after each of the two AdV-tk injections in both arms.
11993615|NCT00638599|Device|LMA®|LMA® is placed after anesthesia induction and removed after the operation
11993616|NCT00638599|Device|Endotracheal tube|Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation
11993617|NCT00638560|Dietary Supplement|Vitamin C, Vitamin E|Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily
11993618|NCT00638560|Dietary Supplement|Antioxidant treatment|no treatment
11993619|NCT00638547|Drug|IRT Laronidase|"Laronidase belongs to a class of drugs called enzyme replacement therapies or ERT that provides people with sufficient quantities of an important enzyme that they cannot create on their own. The main ingredient in laronidase is a protein that is identical to a naturally occurring form of the human enzyme alpha-L-iduronidase. Laronidase replaces the missing enzyme alpha-L-iduronidase and restores sufficient enzyme activity to break down GAG buildup.
~Subjects will receive an infusion of Laronidase into his/her spinal fluid approximately 12 weeks before, 2 weeks before, 100 days after and 6 months after transplant. This procedure is done by lumbar puncture"
11993620|NCT00638534|Drug|Telithromycin (HMR3647)|
11993621|NCT00638508|Drug|Ketorolac|Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
11993622|NCT00638508|Drug|Ketorolac and Ropivacaine|Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
11993623|NCT00638495|Drug|Nalfurafine Hydrochloride (TRK-820)|TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.
11993624|NCT00638495|Drug|Placebo|Placebo is to be administered orally once daily, after supper in principle, for 28 days.
11993625|NCT00638482|Drug|Hydrochlorothiazide|Hydrochlorothiazide
11993626|NCT00638469|Radiation|UVB-311nm|UVB-311nm radiation given 3 times a week to one randomized body half
11993627|NCT00638469|Other|No treatment|no UV exposure
11993628|NCT00638456|Drug|Budesonide plus Prevacid|Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
11993629|NCT00638456|Drug|placebo plus Prevacid|Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
11993630|NCT00638443|Drug|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
11993631|NCT00638443|Drug|Diphenhydramine|diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
11993632|NCT00638417|Behavioral|Maximal strength training|maximal dynamic strength training from 1 week after the operation, 5 training bouts a week for 4 weeks. The regimen consisted of 2 exercises, leg press and hip abduction, that included 4 series of 5RM involving the operated leg only. 5RM corresponds to approximately 85% of 1RM. When the patients managed to perform 6RM, the load was increased by 5kg. The series were separated by resting periods of 2 minutes.
11993633|NCT00638417|Behavioral|conventional rehabilitation|conventional rehabilitation program: inpatient treatment in a rehabilitation center. Individual sling exercise therapy in hip abduction/adduction, hip flexion/extension, exercises with low resistance (>12-15 repetitions37), or no resistance and exercises performed in water when sutures had been removed. Each session lasted 1 hour and was performed 5 days a week for 4 weeks.
11993634|NCT00638391|Drug|Anastrozole|
11993635|NCT00638378|Drug|Ruxolitinib|Ruxolitinib 25 mg tablets taken with water twice a day.
11993636|NCT00638365|Biological|KB001|Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
11993637|NCT00638365|Other|Placebo|Placebo single-dose administered intravenously
11993638|NCT00638326|Drug|clopidogrel|150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
11993639|NCT00638326|Drug|clopidogrel plus placebo|75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year
11993640|NCT00638313|Biological|Placebo|Subjects will be given either Placebo or PF-04603629.
11993641|NCT00638313|Biological|PF-04603629|Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.
11993642|NCT00638300|Device|large pore (FX80) compared to small pore dialyzer (F8HPS)|Effect of pore size
11993643|NCT00638300|Other|Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L|Effect of dialysate bicarbonate concentration
11993644|NCT00638300|Other|Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L|Effect of dialysate calcium concentration
11993645|NCT00638274|Procedure|Air|3 mls used for identifying epidural space
11993646|NCT00638274|Procedure|Saline|3 mls of saline used to identify epidural space
11993647|NCT00638261|Radiation|UVB-311nm|UVB-311nm radiation given 3 times a week to one randomized body-half
11993648|NCT00638248|Drug|Desmoteplase|Desmoteplase 90µg/kg BW i.v. bolus
11993649|NCT00638248|Drug|Desmoteplase|Desmoteplase 125 µg/kg BW i.v. bolus
11993650|NCT00638248|Drug|Placebo|Placebo i.v. bolus
11993651|NCT00638235|Device|AMS Apogee™ with IntePro|Mesh implant for posterior wall pelvic organ prolapse
11993652|NCT00638235|Device|AMS Apogee™ with Intexen LP|Graft implant for posterior wall pelvic organ prolapse
11993653|NCT00638235|Device|AMS Perigee™ with IntePro|Mesh implant for anterior wall pelvic organ prolapse
11993654|NCT00638235|Device|AMS Perigee™ with IntePro Lite|Mesh implant for anterior wall pelvic organ prolapse
11993655|NCT00638235|Device|AMS Apogee™ with IntePro Lite|Mesh implant for posterior wall pelvic organ prolapse
11993764|NCT00637468|Drug|Topical use of beta-blocker|
11993656|NCT00638235|Device|AMS Elevate™ Apical & Posteiror with IntePro Lite|Mesh implant for apical and posterior wall pelvic organ prolapse
11993657|NCT00638235|Device|AMS Elevate™ Apical & Posteiror with IntXen LP|Graft implant for apical and posterior wall pelvic organ prolapse
11993658|NCT00638235|Device|AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)|Mesh implant for anteiror and apical wall pelvic organ prolapse
11993659|NCT00638235|Device|AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)|Mesh implant for anteiror and apical wall pelvic organ prolapse
11993660|NCT00638222|Other|Carvedilol and Placebo|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately.
11993661|NCT00638209|Drug|Human insulin|
11993662|NCT00638209|Drug|Saline|
11993663|NCT00638196|Drug|Linoleic Acid/Oleic Acid|Dietary Supplement: Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid
11993664|NCT00638170|Biological|Cranberry juice|5 ml/kg up to 300 ml, 1-2 doses daily for six months
11993665|NCT00638170|Biological|Placebo juice|5 ml/kg up to 300 ml, 1-2 doses daily for six months
11993666|NCT00638157|Drug|daptomycin|Intravenous (i.v.) 6 mg/kg q24h
11993667|NCT00638157|Drug|daptomycin and gentamicin|i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin
11993668|NCT00638131|Drug|bosentan|62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks
11993669|NCT00638118|Drug|Fexofenadine|
11993670|NCT00638092|Drug|sodium iodide|sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
11993671|NCT00638092|Drug|Sodium Chloride|Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
11993672|NCT00638079|Drug|Megestrol acetate oral suspension 625 mg/5 mL|Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
11993673|NCT00638079|Drug|Megestrol acetate oral suspension 625 mg/5 mL|Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast
11993674|NCT00638066|Drug|botulinum toxin|500 units of botulinum toxin for the second arm
11993675|NCT00638066|Drug|botulinum toxin A|250 units of botulinum toxin A once
11993676|NCT00638053|Genetic|somatropin|Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months
11993677|NCT00638027|Drug|placebo|matched tablets bid
11993678|NCT00638027|Drug|memantine|10 mg bid
11993679|NCT00638014|Device|Rapid Sternal Closure System|Sternal talons will be used and supplemented with wires
11993680|NCT00638014|Device|Conventional wire closure|Conventional wire closure of sternum
11993681|NCT00638001|Device|custom-molded insoles and custom-molded shoes|"custom-made insoles in PELITE foam (hypoallergenic prosthesis grade foam) or leather top cover cork insoles for patients suffering of mild to moderate ankle arthropathy
~custom-molded shoes in leather for patients suffering of end-stage ankle arthropathy"
11993682|NCT00637988|Drug|Esomeprazole|40mg twice daily
11993683|NCT00637988|Drug|Aspirin|
11993684|NCT00637988|Drug|Rofecoxib|25mg once daily
11993685|NCT00637975|Drug|oxycodone|"Arm A - 20 mg/day
~Arm B - increasing dose startnig at 20 mg/day
~For 15 days or until unacceptable toxicity develops."
11993686|NCT00637975|Drug|pregabalin|"Arm A - pregabalin at increasing dose starting from 50 mg/day
~Arm B - pregabalin 50 mg/day
~For 15 days or until unacceptable toxicity develops."
11993687|NCT00637962|Biological|HIV glycoprotein CN54gp140 (vaccine)|vaginal immunisation with 100ug CN54gp140 antigen in gel on 9 occasions in one menstrual cycle
11993688|NCT00637962|Biological|Carbopol 974|vaginal immunisation with Carbopol 974 P 0.924%; benzyl alcohol 1.09%; sodium hydroxide 0.176%; and purified water 97.81%. alone on 9 occasions in one menstrual cycle
11993689|NCT00637949|Device|lumiracoxib|400 mg once daily, oral over 6 weeks
11993690|NCT00637949|Drug|rofecoxib|25 mg, oral, daily over 6 weeks
11993691|NCT00637936|Drug|Oxygen|Inspiratory fraction during anaesthesia
11993692|NCT00637923|Drug|Nitazoxanide|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
11993693|NCT00637923|Drug|Placebo|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
11993694|NCT00637923|Biological|Peginterferon alfa-2a|One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
11993695|NCT00637923|Drug|Ribavirin|Weight-based ribavirin for 48 weeks.
11993696|NCT00637910|Drug|Erlotinib|Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
11993697|NCT00637910|Drug|Docetaxel|Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops
11993698|NCT00637897|Drug|docetaxel|
11993699|NCT00637897|Drug|ixabepilone|
11993700|NCT00637897|Drug|paclitaxel|
11993701|NCT00637897|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
11993702|NCT00637897|Drug|paricalcitol|
11993703|NCT00637884|Drug|Fexofenadine HCl|
11993704|NCT00637871|Drug|Casodex|150mg once daily
11993705|NCT00637871|Drug|Tamoxifen|
11993706|NCT00637858|Dietary Supplement|Lyc-O-Mato 5mg|Daily Lyc-O-Mato 5mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule
11993765|NCT00637468|Drug|Isovolaemic haemodilution|
11993766|NCT00637468|Drug|Acetylsalicylic acid|
11993767|NCT00637455|Drug|fexofenadine HCl|
11993707|NCT00637858|Dietary Supplement|Lyc-O-Mato 15mg|Daily Lyc-O-Mato 15mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule
11993708|NCT00637858|Dietary Supplement|Lyc-O-Mato 30mg|Daily Lyc-O-Mato 30mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule
11993709|NCT00637858|Dietary Supplement|Lycopene capsules (non Lyc-o-mato) 15 mg|Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in).
11993710|NCT00637858|Other|Placebo|Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
11993711|NCT00637845|Drug|Esomeprazole Magnesium|40mg once daily
11993712|NCT00637845|Drug|Lansoprazole|30mg twice daily
11993713|NCT00637832|Biological|rituximab|
11993714|NCT00637832|Drug|cyclophosphamide|
11993715|NCT00637832|Drug|doxorubicin hydrochloride|
11993716|NCT00637832|Drug|prednisolone|
11993717|NCT00637832|Drug|vincristine sulfate|
11993718|NCT00637832|Radiation|yttrium Y 90 ibritumomab tiuxetan|
11993719|NCT00637819|Drug|Leflunomide|A loading dose of LEF 100mg daily for 3 days, followed by LEF 20mg daily for the remainder of the study or matching placebo
11993720|NCT00637806|Drug|Megestrol acetate concentrated suspension 110 mg/mL|Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
11993721|NCT00637806|Drug|Megestrol acetate concentrated suspension 60 mg/mL|Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
11993722|NCT00637806|Drug|Placebo|Placebo oral suspension, 5 mL once daily
11993723|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
11993724|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
11993725|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
11993726|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
11993727|NCT00637780|Drug|Sulfasalazine|Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7
11993728|NCT00637767|Drug|melphalan|
11993729|NCT00637767|Procedure|autologous hematopoietic stem cell transplantation|
11993730|NCT00637767|Radiation|yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183|
11993731|NCT00637741|Device|Everflex 200|
11993732|NCT00637728|Drug|Megestrol acetate concentrated suspension 110 mg/mL|Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
11993733|NCT00637728|Drug|Placebo|Placebo oral suspension, 5 mL once daily
11993734|NCT00637715|Drug|Alfuzosin|
11993735|NCT00637702|Drug|ARRY-334543, EGFR/ErbB2 inhibitor; oral|single dose and multiple dose, escalating
11993736|NCT00637676|Procedure|VATS, Talc-Pleurodesis, tunneled pleural drainage|poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
11993737|NCT00637676|Procedure|VATS, Talc-pleurodesis|poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter
11993738|NCT00637663|Drug|Entecavir|entecavir 0.5 mg QD
11993739|NCT00637663|Drug|Lamivudine|lamivudine 100 mg QD
11993740|NCT00637650|Procedure|Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments|
11993741|NCT00637650|Procedure|Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment|
11993742|NCT00637637|Drug|indinavir sulfate|
11993743|NCT00637637|Drug|ritonavir|
11993744|NCT00637637|Radiation|radiation therapy|
11993745|NCT00637624|Drug|N-Acetylcysteine|N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg
11993746|NCT00637624|Drug|Placebo|Placebo once every 3 weeks intravenous saline fluid
11993747|NCT00637611|Drug|Fexofenadine HCl|
11993748|NCT00637598|Radiation|Mammography and tomosynthesis imaging|All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
11993749|NCT00637585|Drug|Fexofenadine|
11993750|NCT00637572|Drug|Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL|Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)
11993751|NCT00637572|Drug|Megestrol acetate oral suspension 40 mg/mL|Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)
11993752|NCT00637559|Drug|Esomeprazole Magnesium|
11993753|NCT00637546|Other|Physiotherapy|Gait and Balance training based on recommendations of Robertson et al. and Page et al. (different balance control exercises; progression in consecutive stages: Sensimotor training, a static phase, a dynamic phase combined with functional tasks. The treatment takes place twice a week over 12 weeks. Patients were encouraged to perform specific home exercises.
11993754|NCT00637533|Procedure|Lumbar sympathetic block with Botulinum Toxin type A|
11993755|NCT00637507|Other|High-frequency Oscillation and Tracheal Gas Insufflation|Patients will receive daily sessions of High-frequency Oscillation and Tracheal Gas Insufflation (HFO-TGI), which will last at least 6 hours. These sessions will comprise a recruitment period of at least 90 min, a stabilization period of at least 4 hours, and a weaning period of at least 60 min. The HFO-TGI strategy will be aimed at initially maximizing PaO2/FiO2 without causing hemodynamic compromise (e.g., >10% reduction in cardiac output/index), and subsequently maintaining PaO2/FiO2 >150 mm Hg, while gradually reducing mPaw to 4-6 cm H2O below its initial setting. The weaning from TGI and HFO will be according to the reversal of the oxygenation criterion that mandated their use (see also Detailed Description).
11993756|NCT00637494|Drug|mifepristone|1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
11993757|NCT00637494|Drug|placebo|Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
11993758|NCT00637481|Drug|atorvastatin calcium|Given orally
11993759|NCT00637481|Other|laboratory biomarker analysis|Correlative studies
11993760|NCT00637468|Drug|Intravenous injection of heparin|
11993761|NCT00637468|Drug|Intravenous injection of acetazolamide|
11993762|NCT00637468|Procedure|Local intra-arterial fibrinolysis|
11993768|NCT00637442|Drug|Reminyl retard|retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg
11993769|NCT00637416|Drug|Lansoprazole|Lansoprazole 30 mg taken by mouth daily for 3 months
11993770|NCT00637416|Other|Placebo|placebo taken by mouth daily for 3 months
11993771|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with normal renal function (CLcr >80 mL/min)
11993772|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with mild renal impairment (CLcr 50 - 80 mL/min)
11993773|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with moderate renal impairment (CLcr 30 - <50 mL/min)
11993774|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with severe renal impairment (CLcr <30 mL/min and not on hemodialysis)
11993775|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally as 2 single doses of 300 mg (2.4 mL x 125 mg/mL) each in subjects with end stage renal disease undergoing hemodialysis. Washout period of 21 days between each dose
11993776|NCT00637390|Drug|Alemtuzumab|will be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks
11993777|NCT00637377|Drug|Ranibizumab|Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
11993778|NCT00637377|Biological|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
11993779|NCT00637377|Biological|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
11993780|NCT00637377|Biological|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
11993781|NCT00637364|Procedure|High intensity focused ultrasound, HIFU|"The FEP-BY02 HIFU system uses extracorporeal generated high intensity ultrasound, focused on a tumor region of interest, to ablate tissue. A stand-alone B-mode ultrasound is used to locate and define the tumor region of interest. Once defined, the acoustic energy is delivered using a large aperture; fixed focus; sparse transducer array. The concentration of acoustic energy may result in thermal and/or mechanical bioeffects including tissue necrosis, apoptosis, and/or disruption (temporary or permanent) of normal cellular function within the targeted volume (such as nerve conduction).
~The FEP-BY02 High Intensity Focused Ultrasound (HIFU) system is intended to ablate ductal adenocarcinoma of the pancreas with ultrasound-guided targeted delivery of focused ultrasound energy to effect thermal and/or mechanical bioeffects leading to ablation (destruction) of the targeted tumor tissue."
11993782|NCT00637351|Procedure|Blood sample|One blood sample will be collected at the time of screening for subjects
11993783|NCT00637351|Procedure|Urine sample|One urine sample will be collected at the time of screening for subjects
11993784|NCT00637338|Biological|PF-04603629|Subjects will be given either PF-04603629 or Placebo in a blinded fashion. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.
11993785|NCT00637338|Biological|Placebo|Subjects will be given either PF-04603629 or Placebo in a blinded fashion during the study. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.
11993786|NCT00637325|Drug|trastuzumab|In the maintenance study trastuzumab will be administrated once every 3 weeks at the dose of 6 mg/kg by intravenous infusion over 90 minutes until progression of disease. In the 2nd line study, to accomplish the schedule of concomitant second line chemotherapy, trastuzumab will be given on a weekly (2 mg/kg) or a 3-weekly (6 mg/kg).
11993787|NCT00637312|Device|Cervical Artificial Disc (Advent™ Cervical Disc)|Advent™ Cervical Disc
11993788|NCT00637312|Device|Hallmark™ Anterior Cervical Plate System|Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)
11993789|NCT00637299|Other|Active osteopathic treatment (OMT+PR): Active Comparator|The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism).
11993790|NCT00637299|Other|sham osteopathic treatment (SOT+PR)|Only soft manipulation was performed
11993791|NCT00637286|Drug|Zolmitriptan|5mg Nasal Spray
11993792|NCT00637273|Drug|exenatide once weekly|subcutaneous injection, 2.0mg, once a week
11993793|NCT00637273|Drug|sitagliptin|oral tablet, 100mg, once a day
11993794|NCT00637273|Drug|pioglitazone|oral tablet, 45mg, once a day
11993795|NCT00637273|Drug|placebo tablet|oral tablet, once a day
11993796|NCT00637273|Drug|placebo once weekly|subcutaneous injection, once a week
11993797|NCT00637260|Device|Motor cortex stimulation on.|The parameters of stimulation will be: contact 0 cathode, contact 3anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5Volts. The stimulator will be switched on, continuously.
11993798|NCT00637260|Device|motor cortex stimulation off|The parameters of stimulation will be: contact 0 cathode, contact 3 anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5 volts. The stimulator will be switched off.
11993799|NCT00637247|Drug|imexon in combination with gemcitabine|875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
11993800|NCT00637247|Drug|imexon placebo + gemcitabine|imexon placebo IV + 1000 mg/m^2 gemcitabine IV
11993801|NCT00637234|Drug|Oxcarbazepine|Oxcarbazepine (OXC), 300 mg tablets, up to 600 mg three times daily
11993802|NCT00637234|Drug|Placebo|Placebo, 300 mg tablets, up to 600 mg three times daily
11993803|NCT00637221|Drug|NPL-2009|Single doses of either 50mg, 100 mg or 150 mg NPL-2009
11993804|NCT00637208|Procedure|venographic occlusion of spermatic veins|Through the femoral vein a catheter is inserted into the spermatic veins in succession and the veins are occluded.
11993805|NCT00637195|Biological|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)|Intramuscular administration, 3 doses.
11993806|NCT00637195|Biological|Engerix™|Intramuscular administration, 4 doses.
11993807|NCT00637182|Drug|Anastrozole|
11993808|NCT00637169|Other|Titration of oxygen therapy|Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
11993809|NCT00637156|Device|PRESTIGE LP device at two adjacent levels|PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
11993810|NCT00637156|Device|Bi-level fusion with ATLANTIS Cervical Plate System|Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
11993811|NCT00637143|Drug|Tacrolimus|Oral
11993812|NCT00637143|Drug|Cyclosporine|Oral
11993813|NCT00637130|Drug|Travoprost ophthalmic solution, 0.0008%|
11993814|NCT00637130|Drug|Travoprost ophthalmic solution, 0.001%|
11993815|NCT00637130|Drug|Travoprost ophthalmic solution, 0.0012%|
11993816|NCT00637130|Drug|TRAVATAN|
11993817|NCT00637130|Other|Vehicle|
11993818|NCT00637117|Biological|Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS|Day 1 and Day 2: 2 Gy Radiation on Day 1 and Day 2 to tumor site. Day 4, 8, 11, 18: 0.5mL injection of Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS.
11993819|NCT00637104|Device|Mar-Tyn TiN coated Co-Cr Numen stent implant|Implant of the Mar-tyn TiN coated stent
11993820|NCT00637104|Device|Vision Co-Cr stent implant|Implant of the Vision stent
11993821|NCT00637091|Drug|Cetuximab, irinotecan|cetuximab, irinotecan
11993822|NCT00637078|Other|Treatment algorithm:caduet, Amlodipine, ACEI-ARB combo dose, a-blocker, b-blocker or spironolactone, dyslipidemic therapy with ezetamide|initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination followed by a low dose DHP-CCB/statin combination
11993823|NCT00637065|Drug|Bosentan|Bosentan tablets - 62.5mg bd for first 4 weeks, then 125mg bd if tolerated until trial completion.
11993824|NCT00637065|Drug|Placebo|Placebo tables - identical to active drug but without the active ingredient -
11993825|NCT00637052|Drug|ARRY-520, KSP(Eg5) inhibitor; intravenous|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
11993826|NCT00637039|Drug|AZD8931|Tolerability and Pharmacokinetics of AZD8931 in Patients with Advanced Solid Malignancies.
11993827|NCT00637026|Drug|Gefitinib|Iressa
11993828|NCT00637013|Procedure|Acromioplasty|Arthroscopic or open acromioplasty
11993829|NCT00637013|Procedure|Physiotherapy|Physiotherapy according to a standardized protocol
11993830|NCT00637000|Drug|Buprenorphine soluble film|Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment.
11993831|NCT00637000|Drug|Buprenorphine/naloxone film strip|Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment.
11993832|NCT00637000|Drug|Placebo|Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.
11993833|NCT00636987|Device|Biocor and Biocor Supra valves|Replacement for a diseased, damaged, malformed aortic or mitral heart valve
11993834|NCT00636974|Procedure|Combined spinal epidural anaesthesia|
11993835|NCT00636961|Drug|Indacaterol 300μg|300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device
11993836|NCT00636961|Drug|Placebo|Matching placebo devices and hard gelatin capsules
11993837|NCT00636935|Drug|Antibiotics only|Antibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
11993838|NCT00636935|Drug|Antibiotics + Corticosteroids|Prednisone 40mg orally twice daily for 11 days, followed by 40mg once daily for 5 days, followed by 20mg once daily for 5 days and antibiotics (Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone).
11993839|NCT00636935|Drug|Corticosteroids + antibiotics|Drugs will be prescribed per standard of care for patients with PCP and pO2 < 70mmHg.
11993840|NCT00636922|Drug|RAD001(Everolimus)|In this study, 5-azacitidine will be administered sc for 7 doses over 9 days in a 28 day cycle. Everolimus will be administered orally with the first dose starting on day 5 (first Friday) of each cycle and continued until day 21 of each cycle. Patients will be treated with combined azacitidine + Everolimus for a minimum of 6 cycles and until at least 2 cycles after documentation of CR. Upon cessation of azacitidine, the patient will be permitted to take Everolimus maintenance therapy until progression at the investigator's discretion.
11993841|NCT00636909|Drug|Cyclophosphamide|preparative cytoreduction
11993842|NCT00636909|Drug|fludarabine|preparative cytoreduction
11993843|NCT00636909|Drug|cyclosporine|immunosuppressive therapy
11993844|NCT00636909|Drug|methotrexate|immunosuppressive therapy
11993845|NCT00636909|Biological|G-CSF|foster engraftment
11993846|NCT00636896|Drug|Olanzapine plus modafinil|Olanzapine 10 mg/d plus modafinil 200 mg/d
11993847|NCT00636896|Drug|Olanzapine plus placebo|Olanzapine 10 mg/d plus placebo
11993848|NCT00636883|Drug|Gemcitabine|GEMOX-Erlotinib consists of erlotinib 100 mg orally daily starting day 1, Gemcitabine 1000 mg/m2 in 10 mg/m2/min (100 minutes) infusion on day 1 followed on day 2 by oxaliplatin 100 mg/m2 in a 2-hour infusion. Treatment will be repeated every 2 weeks. Each two weeks is a cycle.If at end of 12 cycles response continues, will administer Gemox and erlotinib till achieve maximum response. Then start Erlotinib maintenance therapy.
11993849|NCT00636870|Drug|Fexofenadine|
11993850|NCT00636857|Procedure|Fluid administration|Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr
11993851|NCT00636857|Procedure|Perioperative fluid management based on Lean Body Mass|Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr
11993852|NCT00636831|Drug|Antibiotic: cefazolin Sodium|1g continuous IV at 30 minutes before starting operation
11993853|NCT00636818|Drug|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
11993854|NCT00636805|Drug|Palonosetron (Aloxi) and Dexamethasone|single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
11993855|NCT00636792|Drug|VELCADE|VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.
11993856|NCT00636792|Drug|Bendamustine|Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle
11993857|NCT00636792|Drug|Rituximab|Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5
11993858|NCT00636766|Drug|atorvastatin|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
11993859|NCT00636766|Drug|rimonabant|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
11993860|NCT00636766|Drug|rosiglitazone|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
11993861|NCT00636766|Drug|metformin|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
11993862|NCT00636740|Drug|Zoledronic Acid 20mg Tablets|Oral enteric coated tablets, 20mg, weekly, 8 weeks
11993863|NCT00636740|Drug|Zoledronic Acid|Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
11993864|NCT00636740|Drug|Zoledronic Acid 20mg Tablets|Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8
11993865|NCT00636727|Procedure|arthrocentesis|Irrigate the TMJ with lactated ringers
11993866|NCT00636727|Procedure|arthroscopy|The TMJ will be inspected with an arthroscope and the joint irrigated with lactated ringers
11993867|NCT00636727|Procedure|arthroplasty|The disc will be surgically repositioned with open surgery
11993868|NCT00636714|Behavioral|Nursing judgement|Based on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L
11993869|NCT00636714|Behavioral|Nomogram|A preprinted order outlining a nomogram with instructions for how insulin infusion should be changed based on measured glucose values and how frequent the glucose checks should be
11993870|NCT00636701|Device|Repetitive Transcranial Magnetic Stimulation|We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
11993871|NCT00636688|Behavioral|Lifestyle - detailed advice|Detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity
11993872|NCT00636688|Behavioral|Control - general information|General information about healthy food choices and exercise
11993873|NCT00636675|Behavioral|Falls QI|"Falls uses the Falls Management Program (AHRQ); it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include:
~In-House Falls Coordinator training on content and falls processes.
~Case-based modules about fall prevention and tailored for various team members.
~Academic Detailing in which researcher consults with staff regarding challenging residents with falls.
~Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs.
~Toolbox: Handbook of useful measures and worksheets."
11993874|NCT00636675|Behavioral|Connect|"Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols:
~In-class learning sessions introduce interaction strategies.
~Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions.
~Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role."
11993875|NCT00636662|Other|Non-invasive diagnostic testing|No patient treatment is altered by enrollment in this trial
11993876|NCT00636649|Drug|Escitalopram|10-20 mg
11993877|NCT00636649|Drug|Placebo|Placebo
11993878|NCT00636636|Drug|Gabapentin Extended Release tablets|Once-Daily; 300 mg and 600 mg tablets
11993879|NCT00636636|Drug|Placebo|Once daily; 300 mg and 600 mg tablets
11993880|NCT00636623|Other|Pilates exercises|15 FM patients participated in the PE programme three times a week during a 4-week period
11993881|NCT00636623|Other|Connective tissue massage|21 patients received CTM, three times a week during a 4-week period
11993924|NCT00636285|Drug|BSYX-A110|BSYX-A110, Dosed intravenously, 10 mg/kg
11993882|NCT00636610|Drug|Vismodegib 150 mg|Vismodegib 150 mg was provided in hard gelatin capsules in 3 different strengths, 25 mg, 125 mg, and 150 mg.
11993883|NCT00636610|Drug|Placebo to vismodegib|Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.
11993884|NCT00636610|Drug|Bevacizumab|Bevacizumab 5 mg/kg was administered intravenously (IV) over 90 minutes for the first infusion, shortening to 60 and 30 minutes for subsequent infusions.
11993885|NCT00636610|Drug|Modified FOLFOX|Following administration of bevacizumab, patients received oxaliplatin 85 mg/m^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m^2 (d,I-racemic form, or 200 mg/m^2 I-isomer form) IV administered over 120 minutes, then fluorouracil 400 mg/m^2 administered as an IV bolus, then 2400 mg/m^2 administered as a continuous IV infusion over 46 hours.
11993886|NCT00636610|Drug|FOLFIRI|Following administration of bevacizumab, patients received irinotecan 180 mg/m^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m^2 (d,I-racemic form, or 200 mg/m^2 I-isomer form) administered IV over 120 minutes, then fluorouracil 400 mg/m^2 administered as an IV bolus, then fluorouracil 2400 mg/m^2 administered as a continuous IV infusion over 46 hours.
11993887|NCT00636584|Drug|sodium nitroprusside|sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
11993888|NCT00636584|Drug|placebo|placebo
11993889|NCT00636571|Behavioral|Exercise|Upright bike intervention for post-surgical lung cancer survivors.
11993890|NCT00636558|Drug|CVA21|IV infusion, dose escalation of one or two infusions of escalating strength
11993891|NCT00636545|Drug|Oblimersen (Genasense)|Intravenous
11993892|NCT00636545|Drug|Oblimersen (Genasense)|Intravenous
11993893|NCT00636519|Biological|Botulism Antitoxin Bivalent (Equine) Types A and B|One vial of Botulism Antitoxin Bivalent(Equine) Types A and B (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage A
11993894|NCT00636519|Biological|Botulism Antitoxin Heptavalent (Equine) Types A-G|One vial of Heptavalent Botulism Antitoxin (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage B
11993895|NCT00636506|Device|AMS 700 IPP with MS Pump|AMS 700 Series Inflatable Penile Prosthesis with MS Pump
11993896|NCT00636493|Device|fluocinolone acetonide (Retisert Implant)|sustained release device consisting of 0.59 mg of fluocinolone acetonide
11993897|NCT00636480|Drug|Chlorhexidine gluconate|Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.
11993898|NCT00636480|Drug|ChloraPrep One Step|Administer topically
11993899|NCT00636480|Drug|Sterile saline|0.9% NaCl solution
11993900|NCT00636467|Other|No name|Injection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
11993901|NCT00636454|Behavioral|Coping skills training (CST) for chronic pain|Participants will attend 10 sessions lasting between 45 and 60 minutes each. Topics will include relaxation training, managing activity cycles, and changing thought patterns to reduce the negative effects of pain.
11993902|NCT00636454|Other|Usual care|Participants will receive the care usually given to patients with knee or hip OA.
11993903|NCT00636441|Drug|Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC)|Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) or Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy
11993904|NCT00636428|Drug|Midazolam|oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.
11993905|NCT00636415|Drug|morphine|1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and 25 mg (10 ml) 0.25% bupivacaine without epinephrine.
11993906|NCT00636402|Procedure|Cold Knife Tonsillectomy|Cold Knife Tonsillectomy (CKT) will be done on the other side.
11993907|NCT00636402|Procedure|Vessel Sealing System Tonsillectomy|Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.
11993908|NCT00636389|Device|Polyflux 210H dialyzer|Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
11993909|NCT00636389|Device|Polyflux HD-C4|Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.
11993910|NCT00636376|Procedure|Place HOB in alternate positions from 0-50 degrees.|Patients will receive an US while the HOB(Elevation of the head of bed) is 30 degrees(baseline) then they will increase the angle to 40 degrees, then 50 degrees. Another US will be done then in 20, 10, and o degree angles. Then another US will be done
11993911|NCT00636363|Device|Bausch & Lomb Multipurpose Solution - Rub Care|Daily care for contact lenses - rub care regimen
11993912|NCT00636363|Device|Bausch & Lomb Multipurpose Solution - No Rub Care|Daily care for contact lenses - no rub care regimen
11993913|NCT00636363|Device|Ciba Vision Aquify Multipurpose Solution|daily care for contact lenses
11993914|NCT00636350|Dietary Supplement|Pepper|pepper carotenoids as meals
11993915|NCT00636337|Behavioral|Attention Training|Computer program training for attention difficulties.
11993916|NCT00636337|Behavioral|Placebo|Comparison computer program
11993917|NCT00636324|Device|Nasal CPAP, level 7 to 9 cmH2O|Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation
11993918|NCT00636324|Device|Nasal CPAP, level 4 to 6 cmH2O|Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation
11993919|NCT00636311|Drug|Ifosfamide, Gemcitabine, Vinorelbine|Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
11993920|NCT00636311|Drug|Bortezomib + IGEV|Bortezomib 1,3 mg/sqm, day 1, 4, 8; Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
11993921|NCT00636298|Drug|Bevacizumab, cetuximab|"Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly
~Bevacizumab - 10 mg/kg every 2 weeks"
11993922|NCT00636285|Drug|Placebo|Placebo
11993923|NCT00636285|Drug|BSYX-A110|BSYX-A110, Dosed intravenously, 3 mg/kg
11993926|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks.
11993927|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks.
11993928|NCT00636246|Drug|sertraline|Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
11993929|NCT00636246|Drug|sertraline|Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks
11993930|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.
11993931|NCT00636246|Drug|Placebo|Tablets, orally once per day for 8 weeks
11993932|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks
11993933|NCT00636246|Drug|[S,S]-reboxetine monotherapy|Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
11993934|NCT00636207|Drug|Montelukast|Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
11993935|NCT00636207|Drug|Placebo|Placebo dry powder inhaler
11993936|NCT00636194|Device|Bausch & Lomb Multipurpose Solution|daily care of contact lenses
11993937|NCT00636194|Device|Alcon OptiFree Replenish Multipurpose Solution|daily care for contact lenses
11993938|NCT00636181|Device|Auto AFlex|Positive pressure therapy treatment
11993939|NCT00636181|Device|Auto CPAP|Positive pressure therapy treatment
11993940|NCT00636181|Device|CPAP|Positive pressure therapy treatment
11993941|NCT00636168|Drug|ipilimumab|IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
11993942|NCT00636168|Drug|Placebo|IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
11993943|NCT00636155|Drug|cenersen sodium|2.4 mg/kg/day as a continuous infusion over 24 hours starting on day one and ending on day 4
11993944|NCT00636155|Drug|Rituximab|375 mg/m2 on day 2
11993945|NCT00636155|Drug|Cyclophosphamide|250 mg/m2 on days 2, 3, and 4
11993946|NCT00636155|Drug|Fludarabine|25 mg/m2 on days 2, 3, and 4
11993947|NCT00636142|Biological|Infliximab|5 mg/kg body weight, maximal dose 500 mg; intravenous administration
11993948|NCT00636129|Behavioral|Relaxation Response + Stress Management Curriculum|Subjects will receive 8 weeks of Stress Management curriculum and guidance through 20 minute Relaxation Response with a research coordinator. They will also practice 20 minutes of Relaxation Response at home daily.
11993949|NCT00636116|Biological|Crotalinae (pit viper) equine immune F(ab)2|Anavip with Anavip Maintenance Therapy
11993950|NCT00636116|Biological|Crotalinae (pit viper) equine immune F(ab)2|Anavip with Placebo Maintenance Therapy
11993951|NCT00636116|Biological|Crotalidae Polyvalent Immune Fab, ovine|CroFab with CroFab Maintenance Therapy
11993952|NCT00636103|Drug|CUF2|"0.619g of dried aqueous extract of equal weights of 5 herbs (Astragalus mongholius Bunge, Cordyceps sinensis Sacc., Radix Stemonae, Bulbus Fritillariae Cirrhosae, Radix scutellariae).
~The dosage for children above 12 years old was three capsules twice daily and for children under 12 years old two capsules twice daily.
~Duration: 6 months"
11993953|NCT00636103|Other|Placebo|"Dark coloured corn starch
~The dosage for children above 12 years old was three capsules twice daily and for children under 12 years old two capsules twice daily.
~Duration: 6 months"
11993954|NCT00636077|Device|Polyflux HD-C4 Big|Three consecutive treatments with the HD-C4 Big. During the third treatment, dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
11993955|NCT00636077|Device|HD-C4 Small|Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
11993956|NCT00636077|Device|Optiflux 160NR|Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
11993957|NCT00636077|Device|Optiflux 200NR|Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
11993958|NCT00636064|Drug|Parecoxib Sodium/Valdecoxib|Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
11993959|NCT00636064|Drug|Placebo/Valdecoxib|Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
11994002|NCT00635739|Dietary Supplement|Maltodextrin placebo|powdered, 46g supplement dissolved in fluids, twice daily
11993960|NCT00636064|Other|Placebo/Placebo|Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
11993961|NCT00636038|Dietary Supplement|corn beta-carotene|yellow corn beta-carotene in a 1 mg level to be taken as corn porridge in one meal by volunteers
11993962|NCT00636012|Procedure|verum acupuncture|acupuncture at St36 and Pe6
11993963|NCT00636012|Procedure|sham acupuncture|superficial needling at sham points
11993964|NCT00635999|Behavioral|Applied relaxation and self-control desensitization|Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions.
11993965|NCT00635999|Other|Cognitive therapy (CT)|CT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CT will include 14 weekly sessions.
11993966|NCT00635999|Behavioral|Cognitive-Behavioral Therapy|Includes all of the techniques in the other 2 interventions.
11993967|NCT00635986|Drug|Fentanyl|100 mcg Fentanyl intravenous or epidural route
11993968|NCT00635973|Drug|Gefitinib (Iressa)|Iressa
11993969|NCT00635960|Drug|Growth Hormone (Somatropin)|The initial dose will be 2U s.c. every other day. The dose will be progressively increased to reach 1.5-2x the normal levels of IGF-I.
11993970|NCT00635960|Drug|Placebo|Same as for Growth hormone group
11993971|NCT00635947|Other|isotonic solution|1.5 L- during 2-4hours
11993972|NCT00635947|Other|water|1.5 L- during 2-4hours
11993973|NCT00635947|Other|water|200mL- during 2-4hours
11993974|NCT00635934|Device|A-MAV™ disc|The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level.
11993975|NCT00635921|Drug|ziprasidone|Dose flexible from 40 to 200 mg/d during 12 weeks
11993976|NCT00635921|Drug|Placebo|flexible doses from 40 to 200 mg/d during 12 weeks
11993977|NCT00635895|Other|Manual Lymph Drainage Therapy and Connective Tissue Massage|The treatment program was carried out five times a week, during a 3-week period for both Manual Lymph Drainage Therapy and Connective Tissue Massage groups
11993978|NCT00635882|Drug|mometasone furoate/formoterol 100/10 mcg|mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days
11993979|NCT00635882|Drug|mometasone furoate/formoterol 200/10 mcg|mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days
11993980|NCT00635882|Drug|mometasone furoate/formoterol 400/10 mcg|mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days
11993981|NCT00635882|Drug|MF DPI 200 mcg|MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days
11993982|NCT00635882|Drug|MF MDI 200 mcg|MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days
11993983|NCT00635882|Drug|Placebo|MF/F MDI placebo twice daily (BID) (2 inhalations)
11993984|NCT00635869|Behavioral|ARCC standard information|EBP didactic education sessions, EBP toolkit, environmental prompts, identification of an EBP champion among unit staff RNs
11993985|NCT00635869|Behavioral|ARCC enhanced|same as ARCC standard plus EBP mentor on-site twice each week plus available by e-mail for consultation
11993986|NCT00635869|Behavioral|Placebo|didactic education sessions on physical assessment
11993987|NCT00635856|Drug|Gefitinib|Iressa
11993988|NCT00635843|Device|MAVERICK™ Disc|The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.
11993989|NCT00635843|Device|LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft|The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.
11993990|NCT00635830|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
11993991|NCT00635817|Drug|Leuprolide acetate 11.25 mg|Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.
11993992|NCT00635817|Drug|Leuprolide acetate 30 mg|Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.
11993993|NCT00635804|Drug|MK-3281|MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose. The PM dose of MK-3281 was not administered on Day 7 (for HCV-infected males) or Day 10 (for healthy males)
11993994|NCT00635804|Drug|Placebo to MK-3281|Dose-matched placebo to MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose of MK-3281 in serial panel. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
11993995|NCT00635791|Drug|Sorafenib|Given by mouth
11993996|NCT00635791|Drug|Vorinostat|Given by mouth
11993997|NCT00635778|Drug|dalotuzumab|Administered as an IV infusion over one to two hours
11993998|NCT00635765|Drug|C2L-OCT-01 PR 30 mg|Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.
11993999|NCT00635752|Other|TF-CBT|TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.
11994000|NCT00635752|Other|Treatment as Usual (TAU)|Participants will receive regular therapy as is usually practiced in clinics
11994001|NCT00635739|Dietary Supplement|Whey protein|powdered, 46g supplement dissolved in fluids, twice daily
11995149|NCT00627666|Procedure|allogeneic bone marrow transplantation|
11994003|NCT00635726|Drug|Methotrexate|Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
11994004|NCT00635726|Drug|Vinblastine|Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
11994005|NCT00635726|Drug|Doxorubicin|Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
11994006|NCT00635726|Drug|Cisplatin|Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
11994007|NCT00635726|Drug|Cisplatin|Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
11994008|NCT00635726|Drug|Gemcitabine|Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
11994009|NCT00635713|Drug|Fulvestrant|125mg
11994010|NCT00635713|Drug|Anastrozole|ARIMIDEX
11994011|NCT00635713|Drug|Fulvestrant|250mg
11994012|NCT00635700|Drug|ziprasidone|20-160 mg/d
11994013|NCT00635700|Drug|placebo|placebo
11994014|NCT00635687|Device|Fibroscan|transient elastography measure - Liver stiffness
11994015|NCT00635674|Device|CPAP device - REMstar Plus, Respironics, Murrysville, USA|continuous positive airway pressure device with heated humidification
11994016|NCT00635648|Drug|caspofungin acetate|Intravenous (IV) caspofungin acetate 50 mg/day. Participants with esophageal candidiasis will be treated for at least 7 days and for at least 72 hours after symptoms resolve for a maximum of 28 days; participants with invasive candidiasis will have a 70 mg loading dose on study day 1 and will be treated for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum of 60 days; these participants should also have improvement in clinical and radiographic signs of disease for at least 48 hours before completion of the study therapy.
11994017|NCT00635635|Behavioral|Guided Imagery Audio|Guided Imagery Audio listened to 5x per week
11994018|NCT00635635|Behavioral|Music Audio|Music only audio to be listened to 5x per week
11994019|NCT00635622|Drug|LACTIN-V|Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
11994020|NCT00635622|Drug|Placebo control substance|Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
11994021|NCT00635609|Drug|Doxycycline hyclate (Doryx)|150mg/day, oral, delayed release tablets
11994022|NCT00635609|Drug|Doxycycline hyclate|100 mg/day, oral, tablets, immediate release
11994023|NCT00635596|Biological|MT110|MT110 treatment as continuous intravenous infusion over at least 28 days with increasing doses
11994024|NCT00635583|Other|Increased Dairy Consumption|"3 additional servings of dairy (two of which must be milk or yogurt)
~8 oz milk
~6 oz yogurt
~1.5 oz cheese"
11994025|NCT00635570|Drug|Ortho Tri-cyclen Lo|Low dose oral contraceptive
11994026|NCT00635570|Device|NuvaRing|Contraceptive vaginal ring
11994027|NCT00635557|Drug|MPC-6827 + Carboplatin|MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.
11994028|NCT00635544|Other|dietary treatment|dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
11994029|NCT00635544|Other|dietary treatment|dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
11994030|NCT00635531|Other|placebo|Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
11994031|NCT00635531|Drug|alprazolam XR|Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period.
11994032|NCT00635518|Behavioral|Ten Steps for Healthy Feeding children programme|Ten Steps for Healthy Feeding children
11994033|NCT00635505|Drug|albuterol HFA (Armstrong's)|180 mcg QID 12 weeks
11994034|NCT00635505|Drug|albuterol HFA (Proventil HFA)|180 mcg QID 12 weeks
11994035|NCT00635505|Drug|HFA placebo|2 actuations QID 12 weeks or until use of rescue drug
11994036|NCT00635492|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
11994037|NCT00635492|Drug|any human insulin or analog insulin(s) given in any regimen by subcutaneous injection|
11994038|NCT00635479|Device|VAC device|Vacuum Assisted Closure (VAC) device for surgical incision
11994039|NCT00635479|Other|Gauze dressing|Gauze dressing for surgical incision
11994040|NCT00635466|Procedure|laparoscopic surgery for rectal carcinoma|Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).
11994041|NCT00635453|Behavioral|Dietary Advice|The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.
11994042|NCT00635440|Device|neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)|Electrical stimuli of 50 Hz (pulse width 0.25ms, 8 sec on, 4 sec off) were applied daily for 30 min, for 4 days, starting on the first postoperative day.The amplitude of the electrical stimuli in the stimulated leg was adjusted to ensure maximum tolerable muscle contraction.
11994043|NCT00635440|Device|neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)|Electrical stimuli of 50 Hz (pulse width 0.25ms, 8 sec on, 4 sec off) were applied daily for 30 min, for 4 days, starting on the first postoperative day. Current was increased until the patient could feel a tingling sensation but no muscle contraction was visible or palpable.
11994044|NCT00635427|Biological|VPRIV®|Intravenous infusion, every other week (EOW)
11994045|NCT00635414|Drug|Esomeprazole|40mg oral
11994046|NCT00635414|Drug|Esomeprazole|15 minute intravenous infusion
11994047|NCT00635401|Drug|Varenicline|0.5 mg BID for 7 weeks
11994048|NCT00635388|Other|Placebo|oral, placebo, once/day for 12 weeks
11994049|NCT00635388|Other|Lactobacillus (Probiotic 1)|oral, Lactobacillus, once/day for 12 weeks
11994050|NCT00635388|Other|Lactobacillus and Bifidobacterium (Probiotic 2)|oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks
11994051|NCT00635375|Device|LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)|35-50 mW/cm2/nm
11994052|NCT00635375|Device|Metal halide phototherapy (Spot PT metal halide phototherapy)|29.3-57.6 mW/cm2/nm
11994053|NCT00635375|Device|LED bank phototherapy (Natus neoBlue LED bank phototherapy)|12-35 mW/cm2/nm
11994054|NCT00635375|Device|Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)|29.3-57.6 mW/cm2/nm and 35-50 mW/cm2/nm
11994055|NCT00635362|Device|Levonorgestrel-releasing intrauterine system (LNG-IUS)|Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
11994056|NCT00635362|Device|Levonorgestrel-releasing intrauterine system (LNG-IUS)|Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
11994057|NCT00635349|Drug|Meloxicam|Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85.
11994058|NCT00635349|Drug|Aceclofenac|Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85.
11994059|NCT00635349|Drug|Tramadol Hydrochloride Plus Acetaminophen|Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam [7.5 mg or 15 mg once daily] or aceclofenac [100 mg twice daily]) from Day 1 to Day 28, and fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).
11994060|NCT00635336|Biological|MPHOSPH1 and DEPDC1|DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.
11994061|NCT00635323|Drug|Irinotecan plus capecitabine|Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for
11994062|NCT00635310|Procedure|Percutaneous liver biopsy|Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)
11994063|NCT00635310|Procedure|Percutaneous liver biopsy|Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)
11994064|NCT00635297|Procedure|Percutaneous vertebroplasty|PMMA injection 3-10 milliliter in each treated vertebrae
11994065|NCT00635284|Drug|ABI-009|nab-rapamycin
11994066|NCT00635258|Drug|triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)|0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state.
11994067|NCT00635258|Drug|GnRH antagonist (Orgalutran®)|GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.
11994068|NCT00635245|Biological|figitumumab|
11994069|NCT00635245|Other|imaging biomarker analysis|
11994070|NCT00635245|Other|laboratory biomarker analysis|
11994071|NCT00635245|Other|pharmacological study|
11994072|NCT00635245|Procedure|conventional surgery|
11994073|NCT00635245|Procedure|magnetic resonance spectroscopic imaging|
11994074|NCT00635245|Procedure|neoadjuvant therapy|
11994075|NCT00635232|Drug|irbesartan|300 mg (2 x 150 mg capsules) once daily for 12 weeks
11994076|NCT00635232|Drug|placebo|placebo capsules once daily for 12 weeks
11994077|NCT00635232|Drug|PS433540|200 mg (2 x 100 mg capsules) once daily for 12 weeks
11994078|NCT00635232|Drug|PS433540|400 mg (4 x 100 mg capsules) once daily for 12 weeks
11994079|NCT00635232|Drug|PS433540|800 mg (8 x 100 mg capsules) once daily for 12 weeks
11994080|NCT00635219|Drug|Placebo|capsules; daily; orally
11994081|NCT00635219|Drug|Vortioxetine (Lu AA21004)|2.5 mg/day; encapsulated tablets; orally
11994082|NCT00635219|Drug|Vortioxetine (Lu AA21004)|5 mg/day; encapsulated tablets; orally
11994083|NCT00635219|Drug|Vortioxetine (Lu AA21004)|10 mg/day; encapsulated tablets; orally
11994084|NCT00635219|Drug|Duloxetine|60 mg/day; encapsulated capsules; orally
11994085|NCT00635206|Device|BiPap auto with Fi Flex|"MinEPAP = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)
~MaxIPAP = 25 cm H2O
~MinPS = 2 cm H2O (cannot be adjusted)
~MaxPS = 8 cm H2O
~Bi-Flex setting of 3"
11994086|NCT00635206|Device|Standard CPAP|CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)
11994087|NCT00635193|Drug|M200 (Volociximab)|7.5 mg/kg, IV infusion every week until disease progression
11994088|NCT00635193|Drug|Liposomal Doxorubicin|40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
11994089|NCT00635193|Drug|M200 (Volociximab)|15 mg/kg, IV infusions every week until disease progression
11994090|NCT00635193|Drug|M200 (Volociximab)|15 mg/kg, IV infustions every other week until disease progression
11994091|NCT00635180|Behavioral|isometric exercise|
11994131|NCT00634933|Drug|Prednisone|Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).
11994132|NCT00634933|Drug|TRU-015|IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).
11994092|NCT00635167|Drug|Contrast Enhanced-Transrectal Ultrasound|Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline [Visit 2]); week 5 (middle of treatment [Visit 3]); week 10 (end of treatment [Visit 4]); week 18 (2 months after end of EBRT [Visit 5]); week 26 (4 months after end of EBRT [Visit 6]); and week 36 (6 months after end of EBRT [Visit 7]).
11994093|NCT00635154|Biological|Anakinra (IL-1Ra)|100mg daily subcutaneously administered
11994094|NCT00635154|Drug|Dexamethasone acetate|"Low dose - 20 mg/week
~High dose - 40mg days 1-4, 9-12, 17-20 every 28 days ODD cycles OR 40 mg days 1-4 every 28 days EVEN cycles. (Starting dose was determined by treating physician)"
11994095|NCT00635141|Drug|hypertonic saline (7 %) and isotonic saline (0.9%)|Patients in study arm 1 will receive hypertonic saline (7 %) during the first phase of the study and will crossover to placebo (0.9% isotonic saline) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.
11994096|NCT00635141|Drug|hypertonic saline (7 %) and isotonic saline (0.9%)|Patients in study arm 2 will receive placebo (0.9% isotonic saline) during the first phase of the study and will crossover to hypertonic saline (7 %) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.
11994097|NCT00635128|Biological|Boostrix-Polio|A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
11994098|NCT00635115|Device|a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)|
11994099|NCT00635115|Device|an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)|
11994100|NCT00635102|Drug|D-Cycloserine PO and Glycine IV|Test days will involve administration of D-Cycloserine in the morning in pill form then 4 hours later a 30 minute infusion of Glycine.
11994101|NCT00635102|Drug|Placebo D-Cycloserine PO and placebo Glycine IV|Placebo
11994102|NCT00635102|Drug|Placebo D-Cycloserine PO and Glycine IV|
11994103|NCT00635102|Drug|D-Cycloserine PO and placebo Glycine IV|
11994104|NCT00635089|Drug|reslizumab|
11994105|NCT00635076|Other|placebo|Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
11994106|NCT00635076|Drug|alprazolam XR|Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced.
11994107|NCT00635063|Drug|AD 923|
11994108|NCT00635050|Drug|Doxil, Paclitaxel, Cyclophosphamide, Avastin|"Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.
~Regimen B: Doxil 30 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation."
11994109|NCT00635037|Drug|bupivacaine and acupuncture|"trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h.
~acupuncture twice a week"
11994110|NCT00635024|Biological|anti-thymocyte globulin|2.5 mg/kg
11994111|NCT00635024|Drug|melphalan|16 mg/m^2
11994112|NCT00635011|Behavioral|psychotherapy|Cognitive Behavioral therapy
11994113|NCT00634998|Dietary Supplement|Vitamin C|1000mg Vitamin C capsules orally twice daily
11994114|NCT00634998|Dietary Supplement|Placebo|1000mg Placebo capsules orally twice daily for 90 days
11994115|NCT00634985|Drug|eletriptan|40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response
11994116|NCT00634972|Drug|ACULAR|infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
11994117|NCT00634972|Drug|REFRESH TEARS|infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
11994118|NCT00634972|Drug|placebo|
11994119|NCT00634959|Drug|Maraviroc (UK-427,857)|150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
11994120|NCT00634959|Drug|Maraviroc (UK-427,857)|100 mg oral tablet once daily while fasted on Days 1-10
11994121|NCT00634959|Drug|Maraviroc (UK-427,857)|300 mg oral tablet once daily while fasted on Days 1-10
11994122|NCT00634959|Drug|Maraviroc (UK-427,857)|150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
11994123|NCT00634959|Other|Placebo|Matching placebo oral tablet on Days 1-10 (fed and fasted)
11994124|NCT00634946|Drug|SI-6603|SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
11994125|NCT00634946|Drug|Placebo|Placebo is administrated into the nucleus pulposus of an intervertebral disc.
11994126|NCT00634933|Drug|TRU-015|IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).
11994127|NCT00634933|Drug|Methylprednisolone|IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).
11994128|NCT00634933|Drug|Prednisone|Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)
11994129|NCT00634933|Drug|TRU-015|IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).
11994130|NCT00634933|Drug|Methylprednisolone|IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).
11994208|NCT00634439|Drug|Stimulants|Methylphenidate, amphetamines (including Adderall and mixed salts)
11994133|NCT00634933|Drug|Methylprednisolone|IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).
11994134|NCT00634933|Drug|Prednisone|Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).
11994135|NCT00634920|Drug|everolimus|Everolimus (Certican®) tablets administered orally in two divided doses (b.i.d.) at a starting dose of 4 mg/day adjusted to target a trough blood concentration between 6 and 10 ng/mL in period 2.
11994136|NCT00634920|Drug|cyclosporine A|CsA (Sandimmun Neoral), based on C0-h levels 75-200 ng/mL or C2-h levels 700 900 ng/mL from randomization to Month 6, or C0-h levels 50-150 ng/mL or C2-h levels 600 800 ng/mL from Month 6 to Month 36, according to local method
11994137|NCT00634920|Drug|Enteric Coated Mycophenolate Sodium (EC-MPS)|Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate)
11994138|NCT00634920|Drug|corticosteroids|For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion.
11994139|NCT00634920|Drug|Basiliximab|Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX.
11994140|NCT00634907|Genetic|Pharmacogenetic-based warfarin dosing|"Prior to elective joint replacement surgery a blood sample is collected for genetic information(genotyping)which was used for calculating warfarin doses for patients randomized to the cytochrome arm. Outcomes in terms of efficacy, safety, and management of warfarin were compared between this group and the group in which warfarin doses are determined per usual care.
~NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin was not specific to this study, nor was the duration of prophylaxis, however, warfarin dosing was influenced by the study arm as noted above."
11994141|NCT00634907|Other|Usual care warfarin dosing|"For patients in arm 2, the control group, warfarin dosing is per usual care. Outcomes in terms of safety, efficacy, and warfarin management was compared to that of patients in the other arm, who receive warfarin dosing based on genotyping.
~NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin was not specific to this study, nor was the duration of prophylaxis, however, warfarin dosing was influenced by the study arm as noted above."
11994142|NCT00634894|Drug|Femara|2.5 mg by mouth daily x 12 weeks
11994143|NCT00634894|Drug|Placebo|Placebo capsule by mouth daily x 12 weeks
11994144|NCT00634881|Biological|Alemtuzumab i.v.|"Alemtuzumab will be administered once per week as a 2 h infusion
~Dose level I: 10mg once weekly (start with dose escalation : 3 mg on day 1, 10mg on day 2) Duration
~Dose level II: 20mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 20mg on day 3)
~Dose level III: 30mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 30mg on day 3)"
11994145|NCT00634881|Biological|Alemtuzumab s.c.|"Alemtuzumab will be administered once per week subcutaneously
~Dose level I: 10mg once weekly (start with dose escalation : 3 mg on day 1, 10mg on day 2) Duration
~Dose level II: 20mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 20mg on day 3)
~Dose level III: 30mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 30mg on day 3)"
11994146|NCT00634868|Other|Qray light therapy device|The light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered.
11994147|NCT00634868|Device|Qray light therapy device-Sham|non curative light- the device emits the same broad light, but with very low intensity
11994148|NCT00634842|Drug|insulin detemir|Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
11994149|NCT00634842|Drug|insulin detemir|Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL
11994150|NCT00634829|Drug|albuterol (Armstrong Albuterol HFA)|2 inhalations of 108 mcg albuterol sulfate prior to exercise, single dose
11994151|NCT00634829|Drug|Albuterol Sulfate (Provenetil-HFA)|2 inhalations of Proventil-HFA, 108 mcg/inhalation prior to exercise
11994152|NCT00634829|Drug|Placebo-HFA|Placebo containing HFA propellant without active drug substance
11994153|NCT00634816|Radiation|DXA Scan|The patients will undergo total body, spine, proximal femoral, and forearm DEXA testing in a standardized fashion. Patients who have undergone limb surgery or irradiation to an extremity for local disease control will also undergo selected site DEXA or pQCT scanning, depending upon the site, of the affected extremity and the identical site on the contra-lateral extremity.
11994154|NCT00634803|Behavioral|CBT|Cognitive behavioral therapy
11994155|NCT00634803|Drug|Buprenorphine|buprenorphine/naloxone
11994156|NCT00634803|Other|Educational Counseling|Didactic, lecture-discussion format to supplement information and advice provided by physicians
11994157|NCT00634803|Other|Physician Management|Brief physician counseling
11994158|NCT00634790|Drug|alprazolam XR|Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days.
11994159|NCT00634777|Other|pet scan|pet scan
11994160|NCT00634751|Drug|Oxaliplatin|On days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Following the infusion of oxaliplatin, the infusion line should be flushed with Dextrose 5% in Water.
11994161|NCT00634751|Drug|Capecitabine|Each course of oral capecitabine administration will commence following administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses as above, commencing with each cycle of therapy. Because capecitabine is provided in fixed dose forms, rounding will be necessary. Rounding will be to the nearest 150 mg on a per dose basis.
11994209|NCT00634439|Other|No intervention (general population)|
11994210|NCT00634426|Procedure|Surgical excision of the metastatic process|Surgical excision of the metastatic process
11994211|NCT00634426|Radiation|Radiotherapy of the metastatic spine process|Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
11994162|NCT00634751|Drug|Sorafenib|"Cohort 1 will receive 200 mg of sorafenib orally twice daily, cohort 2 will receive 400 mg orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating).
~Cohort I (Dose escalation phase) Agent Dose Route Day Cycle length
~Sorafenib 200 mg BID Oral Daily Every 28 days
~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd.
~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
~Sorafenib 400 mg BID Oral Daily Every 28 days"
11994163|NCT00634738|Procedure|Ischemic Compression (thumb Pressure)|Pressure, one thumb on the other, applied on the trigger points
11994164|NCT00634725|Drug|capecitabine|
11994165|NCT00634725|Drug|erlotinib hydrochloride|
11994166|NCT00634725|Drug|gemcitabine hydrochloride|
11994167|NCT00634725|Other|laboratory biomarker analysis|
11994168|NCT00634725|Radiation|radiation therapy|
11994169|NCT00634712|Drug|Candesartan|
11994170|NCT00634712|Drug|Placebo|
11994171|NCT00634699|Procedure|Active Comparator, ischemic compressions|Ischemic Compressions,3 times a week,5 weeks.
11994172|NCT00634686|Dietary Supplement|DHA/EPA|1.2 gram capsule daily for 6 months
11994173|NCT00634686|Dietary Supplement|Placebo capsule|daily for 6 months
11994174|NCT00634686|Dietary Supplement|Calcium with vitamin D|1000 mg of calcium with 1000 IU vitamin D daily for 6 months
11994175|NCT00634673|Other|sandwich|standard meal:sandwich (7.23 kcal/kg-total energy; 43.35% fat, 21.95% protein, and 34.70% carbohydrate)
11994176|NCT00634660|Drug|rAvPAL-PEG|rAvPAL-PEG will be administered as a single, SC injection at dose levels of 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1.0 mg/kg. The duration of treatment is a single dose of study drug with 42 days (6 weeks) of follow-up.
11994177|NCT00634647|Drug|Satraplatin|80 mg/m^2 days 1-5 of every 35 day cycle
11994178|NCT00634647|Drug|prednisone|5 mg twice daily every 35 days
11994179|NCT00634634|Drug|Sorafenib|sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
11994180|NCT00634634|Drug|Letrozole|Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
11994181|NCT00634621|Drug|Hexaminolevulinate (Hexvix)|Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied.
11994182|NCT00634608|Other|Health Information Prescription|The patient education materials will consist of approximately 21 topics representing some of the most common conditions seen at the Fairview Internal Medicine Clinic. Twenty-one e-mails, one per topic, will be created by Fairview physicians to be distributed to selected clinic patients. There will be a standard e-mail for each condition with a specific link to MedlinePlus. To create the targeted health information topic email, the physician will review the information available at MedlinePlus. The physician will then select several links of appropriate information and, using the template, will write a short annotation on each link.
11994183|NCT00634595|Drug|E10A|E10A 1*10(12)VP, intratumoral injection, d1 d8, repeat every 3 weeks for 4 cycles
11994184|NCT00634595|Drug|Cisplatin|25 mg/m2/d ivd d3 d4 d5, repeat every 3 weeks for 4 cycles.
11994185|NCT00634595|Drug|Paclitaxel|160 mg/m2 ivd d3, repeat every 3 weeks for 4 cycles.
11994186|NCT00634582|Drug|paricalcitol|
11994187|NCT00634582|Other|immunoenzyme technique|
11994188|NCT00634582|Other|laboratory biomarker analysis|
11994189|NCT00634582|Procedure|dual x-ray absorptometry|
11994190|NCT00634582|Procedure|quality-of-life assessment|
11994191|NCT00634569|Biological|Flebogamma 5% DIF|Intravenous Immune Globulin (Human)
11994192|NCT00634556|Drug|levodopa solution 2mg/ml for i.v. use|2mg/mL in normal saline
11994193|NCT00634556|Drug|placebo|normal saline
11994194|NCT00634543|Drug|Tramadol hydrochloride/ Acetaminophen|Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3,. 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
11994195|NCT00634543|Drug|Gabapentin|Participants will receive Gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg will be administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 3600 mg per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
11994196|NCT00634530|Behavioral|Dietary Advice|The specific dietary advices according to nutritional status. Main advices: reduction of fat and sugar intake, increase of total energy, dairy intake of vegetables and fruits.
11994197|NCT00634517|Drug|Armstrong Albuterol Sulfate Inhalation Aerosol|Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).
11994198|NCT00634517|Drug|Albuterol Sulfate Inhalation Aerosol|Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).
11994199|NCT00634504|Drug|glucarpidase, high-dose methotrexate, leucovorin|single intravenous dose
11994200|NCT00634504|Drug|high-dose methotrexate, leucovorin|standard of care, leucovorin every 6 hours
11994201|NCT00634491|Drug|sodium bicarbonate|150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography
11994202|NCT00634491|Drug|Acetazolamide|Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography
11994203|NCT00634491|Drug|normal salin|1 cc/kg/hr 6 hour before and after angiography
11994204|NCT00634478|Radiation|Pre-lemniscal Radiation Deep Brain Stimulation|
11994205|NCT00634465|Device|RSA Beads|Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes
11994206|NCT00634452|Biological|MDX-1401|IV weekly for 4 weeks
11994207|NCT00634439|Drug|atomoxetine|
11994212|NCT00634413|Drug|Theophylline - ADC4022|Inhaled theophylline (ADC4022) administered twice daily for 28 days
11994213|NCT00634413|Drug|Placebo|Inhaled matching placebo administered twice daily for 28 days
11994214|NCT00634413|Drug|Budesonide|Inhaled budesonide twice daily for 28 days
11994215|NCT00634400|Drug|Candesartan|
11994216|NCT00634400|Drug|Placebo|
11994217|NCT00634387|Dietary Supplement|Anthocyans|Anthocyans
11994218|NCT00634387|Other|placebo|
11994219|NCT00634387|Dietary Supplement|Anthocyans|
11994220|NCT00634374|Device|Rx Medibottle|Comparing use of the Rx medibottle to the oral syringe in delivering a one-time dose of prednisolone syrup
11994221|NCT00634361|Drug|ethyl-eicosapentaenoic acid|2 mg per day
11994222|NCT00634348|Drug|Aripiprazole|Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days
11994223|NCT00634348|Drug|Ziprasidone|Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days
11994224|NCT00634322|Drug|glucarpidase|IV dose based on weight, two doses given for 5 minutes, 24 hours apart
11994225|NCT00634322|Drug|leucovorin|IV or po given every 6 hours
11994226|NCT00634309|Drug|Candesartan|
11994227|NCT00634309|Drug|Placebo|
11994228|NCT00634296|Other|Inspiratory muscle added by aerobic to aerobic alone|Inspiratory muscle added by aerobic to aerobic alone
11994229|NCT00634283|Drug|venlafaxine|venlafaxine IR 150mg
11994230|NCT00634270|Drug|Sirolimus|This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry.
11994231|NCT00634257|Behavioral|Questionnaires|Nine questionnaires taking about 40 minutes to complete.
11994232|NCT00634244|Drug|alvocidib|Given IV
11994233|NCT00634244|Drug|mitoxantrone hydrochloride|Given IV
11994234|NCT00634244|Drug|carboplatin|Given IV
11994235|NCT00634244|Drug|cytarabine|Given IV
11994236|NCT00634244|Drug|sirolimus|Given PO
11994237|NCT00634244|Drug|etoposide|Given IV
11994238|NCT00634244|Drug|topotecan hydrochloride|Given IV
11994239|NCT00634231|Biological|AdV-tk|
11994240|NCT00634231|Drug|valacyclovir|
11994241|NCT00634231|Radiation|Radiation|
11994242|NCT00634218|Behavioral|Mail-based Self-help plus Internet-based Smoking Treatment|Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants.
11994243|NCT00634218|Behavioral|Self-Help Manual plus Telephone counseling|Participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions. The counseling sessions focus on the development of a personalized plan to quit smoking and occur over a 3 month period.
11994244|NCT00634218|Behavioral|Self-Help Manual|Participants will receive a self-help smoking cessation manual specifically developed for LGBT smokers. The manual provides information on quitting smoking and encourages the development of a personalized quit plan through various activities and exercises.
11994245|NCT00634218|Behavioral|Self-Help Manual plus Internet-based Intervention plus Telephone Counseling|Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants. Smokers will also receive 6 telephone-based counseling sessions which occur over a 3 month period
11994246|NCT00634205|Drug|Valproate plus doxorubicin|Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks
11994247|NCT00634192|Drug|tobramycin|1x300mg/d inhaled
11994248|NCT00634192|Drug|tobramycin|2x300mg/d inhaled
11994249|NCT00634179|Drug|Bortezomib|Bortezomib 1.6 mg/m² given on days 1 and 8
11994250|NCT00634179|Biological|Rituximab|Rituximab 375 mg/m²
11994251|NCT00634179|Drug|Doxorubicin|Doxorubicin 50 mg/m²
11994252|NCT00634179|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m²
11994253|NCT00634179|Drug|Vincristine|Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
11994254|NCT00634179|Drug|Prednisone|Prednisone 100 mg/day given orally on days 1-5
11994255|NCT00634166|Drug|Sulfamylon® For 5 % Topical Solution|Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
11994256|NCT00634166|Drug|Topical Antimicrobial/Antifungal Medications|Various topical antimicrobials and antifungals.
11994257|NCT00634153|Other|Research Registry|We are asking for permission to allow us to place subject's past, current and future medical record information into a Surgical Gastrointestinal Disease Registry. By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.
11994258|NCT00634140|Drug|ezetimibe|ezetimibe 10 mg daily for 4 to 6 weeks
11994259|NCT00634140|Drug|Placebo|placebo for 4-6 weeks
11994260|NCT00634114|Drug|Esomeprazole|10mg once daily oral administration
11994261|NCT00634114|Drug|Esomeprazole|20mg once daily oral administration
11994262|NCT00634114|Drug|Omeprazole|10mg once daily oral administration
11994263|NCT00634101|Device|nelfilcon A|contact lens
11994264|NCT00634101|Device|narafilcon A|contact lens
11994265|NCT00634088|Drug|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered orally, once a day, every day, for a 21-day cycle.
11994266|NCT00634088|Drug|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered, 1250 mg, orally, once a day, every day, for a 21-day cycle.
11994267|NCT00634088|Drug|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered orally, once a day, every day, for a 21-day cycle.
11994268|NCT00634088|Drug|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of the triplet combination of ixabepilone, lapatinib, and capecitabine. No participants were enrolled in this arm due to premature termination of the study.
11994269|NCT00634075|Drug|omega-3-fatty acids (Omegaven)|The enrolled patients will be randomized to receive either supplementation of fish oil-based lipid emulsion (10 % Omegaven) as group 1 or placebo (0.9% Normal Saline) as group 2 via a central venous catheter within 24 hours after ICU admission, 100 ml daily for 5 days, respectively.
11994270|NCT00634075|Drug|placebo|The enrolled patients will be randomized to receive either supplementation of fish oil-based lipid emulsion (10 % Omegaven) as group 1 or placebo (0.9% Normal Saline) as group 2 via a central venous catheter within 24 hours after ICU admission, 100 ml daily for 5 days, respectively.
11994271|NCT00634062|Drug|Lamotrigine|Subject in active active drug group will receive lamotrigine tablets 12.5 per day for the first week of the study. Dose of lamotrigine can be increased to 25mg per day during the second week of the study and may be increased each week thereafter for the next 9 weeks by 25mg per day. Subjects in active treatment group will receive lamotrigine for total of 12 weeks
11994272|NCT00634062|Drug|Placebo|Subjects will receive 12.5mg of inert placebo per day during the first week of the study. Inert placebo can be increased to 25mg per day during the second week of the study and by 25mg per day each week for the next 9 weeks. Subjects can receive a total of 12 weeks of placebo.
11994273|NCT00634049|Drug|isavuconazole|Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral
11994274|NCT00634036|Drug|pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
11994275|NCT00634036|Drug|placebo|matching placebo (inert tablet)
11994276|NCT00634010|Drug|Morphine|15 mg oral every 12 Hours; additional capsules taken every 2 hours as needed.
11994277|NCT00634010|Drug|Methadone|5 mg orally every 12 hours; additional capsules every 2 hours as needed.
11994278|NCT00633997|Drug|Vildagliptin|50 mg orally twice daily for 10 days (last dose morning of day 10)
11994279|NCT00633997|Drug|Vildagliptin|
11994280|NCT00633984|Behavioral|Cognitive Behavioral Group Therapy (CBGT)|The patient will then receive 12 weekly sessions of Cognitive Behavioral Therapy lasting approximately two and a half hours each. During these sessions, patients will receive information on the nature of social phobia and a model of treatment and will receive weekly training in how to become more comfortable with social situations, with the goal of achieving confidence in social interactions. As part of this training, the therapist will practice social interactions with the patient, who will also be asked to practice what they have learned outside of the therapists' office.
11994281|NCT00633984|Drug|D-Cycloserine|For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a 50mg pill of d-cycloserine. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have a separate visit in which their levels of symptoms assessed with measures of mood, anxiety, and avoidance.
11994282|NCT00633984|Drug|Placebo|For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a placebo. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have a separate visit in which their levels of symptoms assessed with measures of mood, anxiety, and avoidance.
11994283|NCT00633971|Other|complex lymphedema therapy|Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
11994284|NCT00633958|Other|[18F]-Fluorothymidine|Patients will receive a dose of 18F-FLT through a fresh intravenous catheter as per standard PET procedures. Dosing will be based on age.
11994285|NCT00633945|Drug|Lenalidomide|
11994286|NCT00633932|Drug|Esomeprazole|20mg once daily
11994287|NCT00633932|Drug|Esomeprazole|40 mg once daily
11994288|NCT00633932|Drug|Omeprazole|20mg once daily
11994289|NCT00633919|Biological|SLITone(TM) Dermatophagoides mix|Sublingual immunotherapy with SLITone Dermatophagoides mix (200 STU) once daily for 2 years
11994290|NCT00633919|Biological|Placebo|Sublingual immunotherapy once daily for 2 years
11994291|NCT00633919|Drug|Salbutamol inhaler|200 µg per puff; a short acting beta2-agonist (please refer to the 'detailed description' for details on the use)
11994292|NCT00633919|Drug|Budesonide/formoterol inhaler|80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting beta2-agonist (please refer to the 'detailed description' for details on the use)
11994293|NCT00633919|Drug|Prednisone tablet|5 mg per tablet; oral corticosteroids (please refer to the 'detailed description' for details on the use)
11994294|NCT00633919|Drug|Desloratadine tablet|5 mg per tablet: anti-histamine (please refer to the 'detailed description' for details on the use)
11994295|NCT00633919|Drug|Budesonide nasal spray|64 µg per puff; inhaled corticosteroid (please refer to the 'detailed description' for details on the use)
11994296|NCT00633906|Behavioral|HORIZONS HIV Intervention|Two-session, group-based interactive HIV prevention intervention
11994297|NCT00633906|Behavioral|enhanced standard-of-care|1 hour group session consisting of an HIV prevention video, a question and answer session with an African American woman health educator, and participation in a group discussion about how to avoid acquiring HIV.
11994298|NCT00633893|Drug|Apixaban|Tablets, Oral, twice daily, 12 months
11994299|NCT00633893|Drug|Placebo|Tablets, Oral, twice daily, 12 months
11994300|NCT00633880|Drug|Placebo|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
11994301|NCT00633880|Drug|Droxidopa|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
11994302|NCT00633867|Device|McGrath|Tracheal intubation, using Mcgrath video-laryngoscope
11994303|NCT00633867|Device|Tracheal intubation using Macintosh Laryngoscope|Tracheal intubation using Macintosh Laryngoscope
11994304|NCT00633854|Procedure|Ultrasound examination|Immersion Ultrasound Exam: In the immersion technique, the patient lies down on the examination table. A steridrape with a central aperture is used to form a water-tight seal around the eye. After installation of 2 drops of 0.5% proparacaine HCl, a wire lid speculum is used to hold the patient's lids open. Warm 0.9% sterile saline solution is then used to create a waterbath about 1/2 inch deep to provide acoustic coupling between the transducer and the eye. The transducer (either the 10- and 20-MHz sector scan probe or the annular array) is placed in the waterbath, but does not touch the eye.
11994305|NCT00633841|Biological|AFFITOPE AD02|4 subcutaneous injections of IP in 4-week intervals
11994306|NCT00633828|Behavioral|Increased physical education in primary school (daily)|Increased physical education in primary school, 40 minutes per day
11994307|NCT00633815|Other|Supine positioning|Subjects underwent exercise testing on a stationary bicycle in the supine position
11994308|NCT00633815|Other|Upright positioning|Subjects underwent exercise testing on a stationary bicycle in the upright position
11994309|NCT00633802|Drug|Risperidone|1 mg/d risperidone for 10 weeks or placebo
11994310|NCT00633789|Drug|brivanib|Tablets, Oral, 800 mg, once daily, until progression
11994311|NCT00633789|Drug|Placebo|Tablets, Oral, 0 mg, once daily, until progression
11994312|NCT00633776|Drug|formoterol fumarate|Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
11994313|NCT00633763|Drug|18F-fallypride|Single bolus i.v. injection 60 minutes before PET-CT scanning. Maximum activity per single administration 5 mCi; maximum amount of drug per administration <10 micrograms.
11994314|NCT00633763|Drug|18F-fallypride|I.v. bolus maximum activity per single administration 5 mCi; maximum amount of drug per administration <10 micrograms.
11994315|NCT00633750|Drug|erlotinib hydrochloride|Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
11994316|NCT00633750|Genetic|TUNEL assay|Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
11994317|NCT00633750|Genetic|protein expression analysis|Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
11994318|NCT00633750|Other|immunohistochemistry staining method|Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
11994319|NCT00633750|Other|laboratory biomarker analysis|Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
11994320|NCT00633750|Other|liquid chromatography|Used to determine blood plasma levels of Erlotinib on the day of surgery
11994321|NCT00633750|Other|mass spectrometry|Used to determine blood plasma levels of Erlotinib on the day of surgery
11994322|NCT00633750|Other|matrix-assisted laser desorption ionization mass spectrometry|After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
11994323|NCT00633750|Procedure|therapeutic conventional surgery|Surgical treatment will occur within 24-hours following completion of therapy.
11994324|NCT00633737|Behavioral|Stress reduction intervention|In addition to standard care, patients in the intervention group will receive a one-hour individually delivered programme administered once by a psychologist at least 3 days prior to surgery. This session aims to reduce stress and involves teaching relaxation and guided imagery exercises. Patients are provided a CD (or audiotape)of the relaxation instructions to take home and practice once a day.
11994325|NCT00633724|Biological|HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2|Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 0.5mg, 1.0mg and 3.0mg.
11994326|NCT00633711|Device|Automatic (variable, automatically controlled) pressure CPAP|"CPAP at a variable level according to instantaneous patients' needs for treatment of sleep respiratory disorders, as evaluated by machine's software.
~Home nocturnal usage. Two-month treatment."
11994327|NCT00633711|Device|fixed continuous positive airway pressure (CPAP)|"CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration.
~Home nocturnal usage. Two-month treatment."
11994328|NCT00633698|Drug|Nicotinic acid (niacin)|oral medication Week 1-4: 500 mg per day Week 5-8: 1000 mg per day Week 9-12: 1500 mg per day Week 13-20: 2000 mg per day
11994329|NCT00633698|Drug|Placebo|Placebo Week 1-4: 500 mg per day Week 5-8: 1000 mg per day Week 9-12: 1500 mg per day Week 13-20: 2000 mg per day
11994330|NCT00633685|Drug|Fluoxetine|Fluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response
11994331|NCT00633685|Drug|Placebo|Placebo will be empty gelatin capsules that are identical in size and shape to active treatment
11994332|NCT00633672|Drug|Esomeprazole|20mg Oral tablet once daily
11994333|NCT00633672|Drug|Ranitidine|150mg oral twice daily
11994334|NCT00633672|Drug|Esomeprazole|40mg oral tablet once daily
11994336|NCT00633659|Drug|Voluven (HES 130/0.4)|250 mL of Voluven (HES 130/0.4) solution
11994337|NCT00633646|Dietary Supplement|diets contained different levels of protein|diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d
11994338|NCT00633633|Other|Usual Care|Monthly visits with the cardiology team and a booklet about coping with heart failure.
11994339|NCT00633633|Behavioral|Exercise Training|Exercise training 3 times a week.
11994340|NCT00633633|Behavioral|Dietary Counseling|Food log, booklet, and a cookbook to help decrease the salt content in your diet.
11994341|NCT00633620|Device|Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)|colonoscopy withdrawal with NBI mode
11994342|NCT00633607|Other|Research Registry|Information regarding medical and family history is stored in the registry to be used for potential future studies
11994343|NCT00633594|Drug|Rituximab|"DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1
~Same for DL-1."
11994344|NCT00633594|Drug|Bortezomib|"DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11
~Same for DL-1."
11994345|NCT00633594|Drug|Lenalidomide|"DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest
~DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest
~DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest
~DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest"
11994346|NCT00633581|Dietary Supplement|Ascorbic acid (Vitamin C)|Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes
11994347|NCT00633581|Dietary Supplement|Normal saline|Single intravenous injection of 120ml of normal saline over 30 minutes
11994348|NCT00633568|Drug|Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel|Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
11994349|NCT00633568|Drug|Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel|Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
11994350|NCT00633542|Drug|thalidomide|100 mg/day orally until progression or severe toxicity
11994351|NCT00633542|Drug|interferon alpha|3 MU 3 times a week until progression or severe toxicity
11994352|NCT00633529|Drug|IMO-2055|0.08, 0.16, or 0.32 mg/kg SC (subcutaneous) on days 1,8,and 15 of every 21 day cycle until evidence of progressive disease, unacceptable treatment-related toxicities, withdrawal of patient consent and/or Investigator decision to withdraw study therapy with documented reason, whichever occurs first.
11994353|NCT00633516|Device|Optical Spectroscopy|Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy
11994354|NCT00633490|Drug|apatinib|apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
11994355|NCT00633477|Drug|Resatorvid|Resatorvid 1.2 mg/kg emulsion, injection for 30 minutes and resatorvid 2.4 mg/kg per-day emulsion, injection, continuous infusion for 96 hours.
11994356|NCT00633477|Drug|Placebo|Resatorvid placebo-matching emulsion, injection for 30 minutes and resatorvid placebo-matching emulsion, injection, continuous infusion for 96 hours.
11994357|NCT00633464|Drug|ixabepilone|"injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first.
~Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria."
11994358|NCT00633464|Drug|ixabepilone + cetuximab|"Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.
~Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria.
~Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.
~Cetuximab 400 mg/m^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria."
11994359|NCT00633451|Other|Manual Therapy and Exercise|Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.
11994360|NCT00633451|Other|Exercise Only|A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
11994361|NCT00633438|Other|Placebo|Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed
11994362|NCT00633438|Drug|Celecoxib|400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed
11994363|NCT00633425|Drug|GLIMEPIRIDE|
11994364|NCT00633412|Drug|Esomeprazole|20mg oral daily
11994365|NCT00633412|Drug|Ranitidine|150mg oral twice daily
11994366|NCT00633412|Drug|Esomeprazole|40mg oral tablet daily
11994367|NCT00633399|Drug|Ziprasidone|20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
11994368|NCT00633399|Drug|Placebo|"0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
11994369|NCT00633386|Drug|Celecoxib|400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery
11994370|NCT00633386|Other|Placebo|Matched placebo
11994371|NCT00633373|Drug|Cyclosporine Inhalation Solution|Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.
11994372|NCT00633360|Drug|Drospirenone and ethinyl estradiol|Once daily by mouth
11994373|NCT00633360|Drug|Placebo|Once daily by mouth
11994374|NCT00633347|Drug|Antagonist GnRH Cetrotide|Cetrotide 0.25 mg. daily/ 7 days
11994375|NCT00633347|Drug|Agonist GnRH Acetate Triptoreline|Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
11994376|NCT00633334|Other|Specimen bank|Patients will be asked to provide approximately 60-120 cc (4-8 tablespoons) of peripheral blood. Select patients who undergo surgical resection of their tumor will be asked to provide portions of the tumor and tumor draining lymph nodes for further analysis. In addition patients undergoing surgical resection may be asked to provide additional peripheral blood samples at time of routine follow-up (at least 4-6 weeks after initial blood draw and between subsequent draws).
11994377|NCT00633321|Biological|TA-NIC|TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
11994378|NCT00633321|Biological|Placebo|Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
11994379|NCT00633308|Device|NxStage System One (NxStage Medical, Lawrence, MA)|Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.
11994380|NCT00633295|Drug|AMN107- NILOTINIB|The dose of nilotinib will be 400 mg bid.
11994381|NCT00633282|Behavioral|Life style intervention|"calorie limited diet: to subtract 500 kcal from daily mean calorie intake when entering the treatment
~activity: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate; or higher-intensity aerobic exercise for more than 90min per week with heart rate around 70% of the maximal heart rate"
11994382|NCT00633282|Drug|pioglitazone|pioglitazone tablet,15mg qd ,30 minutes before breakfast,for 16 weeks
11994383|NCT00633282|Drug|berberine|berberine tablet 0.5g tid,30 minutes before each meal,for 16 weeks
11994384|NCT00633269|Drug|AZD2281|100mg Oral Dose
11994385|NCT00633256|Drug|Cycloserine|50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
11994386|NCT00633256|Drug|Placebo|Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.
11994387|NCT00633243|Procedure|Modified Directly Observed Therapy (mDOT)|
11994388|NCT00633243|Procedure|Self-Administered Therapy (SAT)|
11994389|NCT00633230|Drug|standardized herbal formula, Sho-saiko-to (SST)|3 capsules containing 700 mg of the Sho-saiko-to (SST) herbal extract/capsule and 28 mg of the excipients, magnesium stearate, and silicon dioxide/capsule 2 x day
11994390|NCT00633230|Other|placebo capsule identical to the active herbal formula|3 placebo capsules 2 x day
11994391|NCT00633217|Drug|Fluticasone Propionate/Salmeterol DISKUS 250/50mcg|treatment drug
11994392|NCT00633217|Drug|Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg|treatment drug
11994393|NCT00633204|Biological|MPHOSPH1 and DEPDC1|DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week after curative surgery 8 times and BCG in bladder simultaneously. Then, DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered once every month. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.
11994394|NCT00633191|Drug|Anti-pseudomonas IgY gargle|Gargle (solution), > 5FKU, every night after toothbrushing, life-long
11994395|NCT00633178|Behavioral|Group interpersonal therapy (IPT)|Group IPT will include weekly treatment sessions with a psychiatrist for 12 weeks. The sessions will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women.
11994396|NCT00633178|Behavioral|Treatment as usual (TAU)|TAU will include referrals to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving medication for their depression may last longer than 12 weeks.
11994397|NCT00633165|Drug|Brostallicin|Patients will receive Brostallicin administered intravenously (IV) over 10 minutes at a dose of 10 mg/m2 on day one of a 21-day cycle. Safety and efficacy will be closely monitored and assessed.
11994398|NCT00633152|Drug|ceftaroline|600 mg injected every 12 hours for at least 5 but not more than 14 days
11994399|NCT00633152|Drug|linezolid|600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
11994400|NCT00633152|Drug|Aztreonam|1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.
11994401|NCT00633139|Biological|Recombinant human Arylsulfatase A (rhASA)|intravenous infusion, every other week for 26 weeks
11994402|NCT00633126|Drug|ceftaroline|Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.
11994403|NCT00633113|Procedure|MPPA|- Medial Parapatellar Arthrotomy
11994404|NCT00633113|Procedure|SV|- Subvastus Technique
11994405|NCT00633087|Drug|2-deoxyglucose|30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
11994406|NCT00633074|Biological|Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)|Intramuscular administration, 1 dose
11994407|NCT00633074|Biological|Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)|Intramuscular administration, 1 dose
11994408|NCT00633061|Drug|Enoxaparin|Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children >2 months and 1.5 mg/kg every 12 hours for infants <2 months. Duration of treatment is 6 weeks.
11994409|NCT00633048|Drug|NSA-789|
11994410|NCT00633048|Drug|placebo|
11994411|NCT00633035|Drug|esomeprazole 40 mg|esomeprazole 40 mg po given for 7 days
11994412|NCT00633035|Drug|famotidine 20 mg|famotidine 20 mg intravenous bolus q12h for 7 days
11994413|NCT00633022|Drug|LOSMAPIMOD 7.5 MG|GW856553 tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised GW856553X active substance. Tablets are available containing 7.5 mg of GW856553X and are packed into high-density polyethylene (HDPE) bottles.
11994496|NCT00632489|Drug|Lapatinib|Lapatinib, 1000 mg PO daily will be added to this combination.
11994497|NCT00632476|Other|Placebo|Placebo capsule once a day
11994414|NCT00633022|Drug|Placebo|Placebo tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised substance to visually match the active GW856553 tablets are also available. Tablets are packed into high-density polyethylene (HDPE) bottles.
11994415|NCT00633009|Biological|Leishmania tropica Skin Test Antigen (LtSTA)|Administer 15 ug, 30 ug or 50 ug of LtSTA into DTH positive volunteers. Repeat drug administration 30 days after initial injection and 60 days after initial injection. Read and interpret reaction 48 hours after each injection. Observe subjects for conversion or adverse reaction.
11994416|NCT00633009|Biological|Leishmania tropica Skin Test Antigen Placebo (Placebo)|Administer Placebo concurrently with 15 ug, 30 ug and 50 ug doses of LtSTA. Read and interpret the reaction 48 hours after injection. Observe subjects for reaction to Placebo
11994417|NCT00632996|Other|Rehabilitation|Exercise, manual therapy, patient education, posture, home exercise program
11994418|NCT00632970|Drug|Raltegravir|1, 400mg tablet twice a day, with Truvada 1 tablet once a day
11994419|NCT00632970|Drug|Lopinavir/Ritonavir|2 tablets twice a day, with Truvada 1 tablet once a day
11994420|NCT00632970|Drug|Truvada|1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
11994421|NCT00632957|Dietary Supplement|Omega-3 Fatty acid (with SRP or OHI)|1000mg capsules three times daily, duration 28 weeks.
11994422|NCT00632957|Dietary Supplement|Placebo|corn/soybean oil capsules 1g/three times daily
11994423|NCT00632931|Drug|vorinostat|A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.
11994424|NCT00632931|Drug|Comparator: placebo (unspecified)|A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).
11994425|NCT00632866|Drug|Hydroxychloroquine|Hydroxychloroquine : 200mg / day since 24 weeks
11994426|NCT00632866|Drug|Placebo|Placebo : 2cp/ day since 24 weeks
11994427|NCT00632853|Radiation|Standard Radiation Dose Therapy|45 Gy
11994428|NCT00632853|Drug|cisplatin|IV
11994429|NCT00632853|Drug|etoposide|IV
11994430|NCT00632853|Radiation|High Radiation Dose Therapy|70 Gy
11994431|NCT00632853|Drug|carboplatin|IV
11994432|NCT00632840|Drug|Atorvastatin and fenofibrate|atorvastatin (40mg/day) fenofibrate (200mg/day)
11994433|NCT00632827|Drug|Gemcitabine|Chemotherapy medication used to treat a number of types of cancer
11994434|NCT00632827|Drug|Navelbine|Navelbine is an chemotherapy medication used to treat a number of types of cancer
11994435|NCT00632827|Drug|Doxorubicin Hydrochloride Liposome Injection|Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug
11994436|NCT00632827|Drug|Granulocyte-colony stimulating factor (G-CSF)|G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.
11994437|NCT00632827|Drug|Pegfilgrastim|Colony-stimulating factor 3 (CSF 3) and, is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. May be used instead of G-CSF
11994438|NCT00632827|Drug|Cyclophosphamide|Cancer medication that interferes with the growth and spread of cancer cells in the body
11994439|NCT00632827|Drug|Vincristine|Vincristine is a chemotherapy medication used to treat cancer. Vincristine works by stopping the cancer cells from separating into 2 new cells to stops the growth of the cancer
11994440|NCT00632827|Drug|Leucovorin|Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer.
11994441|NCT00632827|Drug|Methotrexate|Methotrexate is a chemotherapy medication used to treat cancer
11994442|NCT00632827|Drug|Doxorubicin Hydrochloride|Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer
11994443|NCT00632827|Drug|Cytarabine|Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma
11994444|NCT00632827|Drug|Etoposide|Etoposide is a is a chemotherapy medication used to treat cancer
11994445|NCT00632827|Drug|Carmustine|Carmustine is a chemotherapy medication used to treat cancer
11994446|NCT00632827|Drug|Denileukin diftitox|Denileukin diftitox is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. Denileukin diftitox could bind to Interleukin-2 receptors and introduce the diphtheria toxin into cells that express those receptors, killing the cells
11994447|NCT00632814|Drug|rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
11994448|NCT00632814|Drug|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
11994449|NCT00632814|Drug|rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for patients in this group
11994450|NCT00632801|Other|chewing gum|The patients in the gum chewing group (intervention group) will chew one stick of gum the first post-operative day, after the nasogastric tube is removed or if they patient does not have a nasogastric tube, with the head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set intervals
11994451|NCT00632788|Other|acute myocardial infarction checklist|For every patient fulfilling the criteria of enrollment, an acute myocardial infarction checklist was incorporated into the patient's medical records at emergency department immediately after a diagnosis of acute ST-elevation myocardial infarction was made. All the time sequences concerning different managements at different locations were recorded by nurses and/or physicians as instructions on the checklist.
11994452|NCT00632775|Drug|Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids|"Total daily fluid infusion equal to:
~100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg."
11994453|NCT00632775|Drug|Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids|"Total daily fluid infusion equal to:
~100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg."
11994454|NCT00632762|Drug|mantadix|dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
11994455|NCT00632749|Drug|BI 811283 (d 1 and 15)|BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle
11994456|NCT00632749|Drug|Cytarabine|Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
11994457|NCT00632749|Drug|BI 811283 (d1)|BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle
11994458|NCT00632749|Drug|Cytarabine|Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
11994459|NCT00632736|Drug|Ropinirole XL (formerly CR)|
11994460|NCT00632723|Drug|gefitinib (IRESSA™, ZD1839)|250 mg tablet; daily dose 500 mg daily
11994461|NCT00632710|Other|phototherapy|The laser used was low-level Aluminum Gallium Arsenide (AlGaAs)diodo laser, at a wavelength of 785 nm (infrared), dose of 3 J/cm2, mean power of 70 mW, 3 sec. per point, laser beam of 0,06cm2, BIOSET brand - Indústria de Tecnologia Eletrônica Ltda -Rio Claro, Brazil.
11994462|NCT00632710|Other|phototherapy placebo|disconnected laser (same device - experimental group)
11994463|NCT00632697|Drug|pentoxifylline|800 mg daily for six months
11994464|NCT00632697|Drug|placebo|
11994465|NCT00632684|Behavioral|Interviews with a single treatment planning session|Participants in Phase 1 will attend four 90-minute interviews over 4 months. During interviews, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. Participants will also receive information about programs and services that may help them carry out caregiving activities.
11994466|NCT00632684|Behavioral|Adaptive treatment model|The adaptive treatment model will include up to ten 60- to 75-minute planning sessions. The sessions will focus on psychosocial issues and will be tailored to participants' specific risk factors.
11994467|NCT00632645|Drug|Olanzapine|Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day
11994468|NCT00632645|Drug|Xenazine|Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
11994469|NCT00632645|Drug|Tiapridal|Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day
11994470|NCT00632632|Drug|D-Cycloserine|Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
11994471|NCT00632632|Other|Placebo|Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times).
11994472|NCT00632619|Behavioral|Group-based behavior therapy|Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
11994473|NCT00632619|Drug|Stimulant medication therapy|All participants will be stabilized on an FDA-approved stimulant medication for 2 to 6 weeks prior to therapy assignment.
11994474|NCT00632619|Behavioral|Community-based psychosocial treatment|Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
11994475|NCT00632606|Drug|magnesium sulfate|magnesium sulfate 2 grams intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally
11994476|NCT00632606|Drug|metoclopramide|metoclopramide 10 mg intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally
11994477|NCT00632593|Procedure|Laparoscopic Gastric Bypass|
11994478|NCT00632593|Procedure|Laparoscopic Gastric Bypass|
11994479|NCT00632580|Drug|intraarticular injection with ropivacaine|
11994480|NCT00632580|Drug|extraarticular injection with ropivacaine|
11994481|NCT00632567|Procedure|caesarean section|caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
11994482|NCT00632567|Procedure|vaginal delivery|vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
11994483|NCT00632554|Drug|prednisolone 0.5 mg/kg/day for three months|period of treatment
11994484|NCT00632554|Drug|prednisolone 0.5 mg/kg/day for six months|period of therapy
11994485|NCT00632541|Drug|Sorafenib|Sorafenib 200mg po daily
11994486|NCT00632541|Drug|Bevacizumab|"Bevacizumab 5mg/kg every other week
~1 Cycle = 4 weeks"
11994487|NCT00632541|Other|Imaging|Imaging every third cycle
11994488|NCT00632528|Drug|MEOPA|Administration of MEOPA gaz during postoperative physical therapy
11994489|NCT00632528|Drug|Medicinal air|Administration of medical air during postoperative physical therapy
11994490|NCT00632515|Behavioral|Questionnaire|Questionnaire regarding awareness of screening tests and attitudes toward colorectal cancer screening, taking 30-45 minutes to complete.
11994491|NCT00632502|Drug|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks.
11994492|NCT00632502|Drug|Placebo|Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.
11994493|NCT00632502|Drug|Rescue medication|Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
11994494|NCT00632489|Drug|LBH589|LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
11994495|NCT00632489|Drug|Capecitabine|Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
11994498|NCT00632476|Dietary Supplement|Vitamin C|A 500-mg vitamin C capsule once a day
11994499|NCT00632463|Biological|RI-001|Dose 1
11994500|NCT00632463|Biological|RI-001|Dose 2
11994501|NCT00632463|Biological|RI-001|Placebo
11994502|NCT00632437|Procedure|Speckle-Contrast Imaging|Imaging camera scan that uses reflected red light to take pictures of the amount of blood flowing in brain and the amount of oxygen in blood.
11994503|NCT00632424|Drug|Ixabepilone (oral formulation)|Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity
11994504|NCT00632411|Drug|Nicotine Patch|"Participants who smoke more than 20 cigarettes per day will use a 21-mg patch for 4 weeks, a 14-mg patch for the next 2 weeks, a 7-mg patch for the next 2 weeks, and then no patch.
~Participants who smoke between 10 to 19 cigarettes per day will use a 14-mg patch for 4 weeks, a 7-mg patch for the next 4 weeks, and then no patch.
~Participants who smoke between 5 to 9 cigarettes per day will use a 7-mg patch for 8 weeks and then no patch.
~The proactive group will be given 8 weeks of patch treatment and the reactive group will be given 2 weeks of patch treatment."
11994505|NCT00632411|Behavioral|Tobacco Quit Line Program|"Phone session 1 will focus on smoking reduction.
~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days. Nicotine patches will be sent to participant with detailed instructions for patch use.
~Phone session 3 will focus on the first days after the quit date.
~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.
~Phone session 5 will focus on short-term relapse prevention.
~Phone session 6 will focus on long-term relapse prevention."
11994506|NCT00632398|Behavioral|Attention control (reading)|Caregivers read to the patient from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks
11994507|NCT00632398|Behavioral|Touch, Caring and Cancer DVD program|DVD- and manual-based instruction for caregivers and patients in the use of touch and massage techniques as supportive care in cancer, including: preparation for a session, safety precautions related to cancer and its treatments, communication about touch, centering to calm the mind; manual techniques for the head, neck, shoulders, back, feet and hands to promote relaxation; and acupressure for pain, nausea and anxiety.
11994508|NCT00632385|Drug|Eletriptan|40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose
11994509|NCT00632372|Device|Cardiac Resynchronization Therapy|Pacing of the left ventricle to resynchronize ventricular contraction.
11994510|NCT00632372|Device|HeartPOD™ System|Left atrial pressure monitoring.
11994511|NCT00632359|Drug|Lenalidomide|10 mg daily given for 12 months
11994512|NCT00632333|Biological|URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil|Escalating dose of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 will be administered by subcutaneous injection on days 15, 22, 28 and 35 of treatment cycle. Doses of each peptide are planning 0.5mg, 1mg and 3mg/body. Chemotherapy plus radiation therapy will be done as follows: fluorouracil (400mg/m2) on day1-5 and 8-12, cisplatin (40mg/m2) on days 1 and 8, radiation (2Gy) on days 1-5, 8-12 and 15-19. Two cycles of combination of chemoradiation therapy and epitope peptide vaccine therapy will be done.
11994513|NCT00632294|Procedure|Tissue Sample|A leftover sample of the removed allograft bone will be collected.
11994514|NCT00632281|Radiation|Stereotactic Body Radiation Therapy|Prescription dose: 48 Gy or 60 Gy RT
11994515|NCT00632268|Drug|RAD001; Cisplatin; 5-FU; Leucovorin|RAD001: oral 10mg/day on Day 1,8,15 Cisplatin:infusion 35mg/m2/day on Day 1,8 5-FU:infusion 2000mg/m2/day on Day 1,8,15
11994516|NCT00632255|Drug|Imatinib|Conventional therapy with imatinib
11994517|NCT00632242|Drug|ARC1779|Initial stepwise infusion of 0.23 mg/kg given over 30 minutes and subsequent continuous infusion of an additional 0.24 mg/kg given over 4 hours at a rate of 0.001 mg/kg/min.
11994518|NCT00632242|Drug|ARC1779|Initial stepwise infusion of 0.23 mg/kg given over 30 minutes and subsequent continuous infusion of an additional 1.44 mg/kg given over 24 hours at a rate of 0.001 mg/kg/min.
11994519|NCT00632242|Drug|ARC1779|Initial stepwise infusion of 0.46 mg/kg over 30 minutes and subsequent continuous infusion of an additional 2.88 mg/kg given over 24 hours at a rate of 0.002 mg/kg/min.
11994520|NCT00632242|Drug|ARC1779|"Initial stepwise infusion of 0.23 mg/kg given over 30 minutes and subsequent continuous infusion of an additional 1.44 mg/kg given over 24 hours at a rate of 0.001 mg/kg/min to produce a target plasma concentration of 6 mcg/mL.
~Continuous infusion of ARC1779 Injection may continue for ≤ 14 days. After initial 24 hours dose may be titrated to achieve a target plasma concentration of 12 mcg/mL as needed, on the basis of clinical and laboratory data, according to the Investigator's judgment."
11994521|NCT00632242|Drug|ARC1779|In one period of the sequence, ARC1779 will be administered to all subjects as a stepwise infusion of 0.23 mg/kg over 30 minutes and subsequent continuous infusion of an additional 0.24 mg/kg given over 4 hours at a rate of 0.001 mg/kg/min in combination with a dummy 30-minute infusion of placebo. In another period, subjects will receive a single infusion of desmopressin at a dose of 0.4 mcg/kg given over 30 minutes in combination with a dummy 30-minute stepwise infusion followed by 4-hour continuous infusion of placebo. In the one other period, subjects will receive the combination of desmopressin at a dose of 0.4 mcg/kg given over 30 minutes and ARC1779 given as a stepwise infusion of 0.23 mg/kg over 30 minutes and subsequent continuous infusion of an additional 0.24 mg/kg given over 4 hours at a rate of 0.001 mg/kg/min
11994522|NCT00632229|Drug|Paliperidone|Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
11994523|NCT00632229|Drug|Placebo|Pill placebo taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
11994524|NCT00632216|Drug|Risedronate Sodium|
11994525|NCT00632203|Drug|Temozolomide|5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
11994526|NCT00632190|Other|fluorophotometry|
11994527|NCT00632190|Procedure|colposcopic biopsy|
11994528|NCT00632190|Procedure|colposcopy|
11994529|NCT00632190|Procedure|light-scattering spectroscopy|
11994530|NCT00632138|Behavioral|exercise intervention|
11994531|NCT00632138|Other|questionnaire administration|
11994532|NCT00632138|Procedure|biofeedback|
11994533|NCT00632138|Procedure|management of therapy complications|
11994536|NCT00632125|Drug|HX575 recombinant human erythropoietin alfa|HX575 epoetin alfa i.v. will be administered according to the SmPC
11994537|NCT00632099|Drug|Oral micronized progesterone|Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
11994538|NCT00632099|Drug|Placebo|matched placebo
11994539|NCT00632086|Drug|PA32540|
11994540|NCT00632086|Drug|aspirin component of PA32540|The 325 mg aspirin component of PA32540
11994541|NCT00632086|Drug|Ecotrin|325 mg Ecotrin
11994542|NCT00632073|Drug|Vicriviroc|One tablet of vicriviroc maleate 30 mg once daily for 24 weeks (added to the subject's failing antiretroviral background regimen for 2 weeks, and then administered with optimized background therapy).
11994543|NCT00632060|Procedure|Manual / Manipulative Therapy (M/MT)|Subjects will receive M/MT twice a week for 4 weeks
11994544|NCT00632047|Other|active surveillance|
11994545|NCT00632047|Other|educational intervention|
11994546|NCT00632047|Procedure|examination|
11994547|NCT00632047|Procedure|long-term screening|
11994548|NCT00632034|Other|CD34+ haemopoietic stem cells|Expanded subset of CD34+ haemopoietic stem cell. Harvested from pelvic marrow aspiration at Day 0 of study. Undergoes refinement and minimum of 1000 fold expansion over 7 days in a dose escalation regime of a maximum dose of 1,000,000,000 cells in 5 millilitres. Injected at Day 7 via contralateral femoral artery under angiographic guidance. First regime up to 10,000,000 cells, second 100,000,000 cells, final regime maximum of 1,000,000,000 cells.
11994549|NCT00632021|Behavioral|Pharmacist Intervention for Low-Literacy in Cardiovascular Disease|Before hospital discharge, a pharmacist will provide medication reconciliation and counseling on how to take medications. Participants will receive a follow-up phone call 1 to 4 days after hospital discharge to discuss any medication problems, and additionally as needed.
11994550|NCT00632008|Drug|Soluble beta-glucan (SBG)|Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks
11994551|NCT00632008|Drug|Placebo comparator|Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.
11994552|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
11994553|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
11994554|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
11994555|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
11994556|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
11994557|NCT00631995|Dietary Supplement|Meningococcal polysaccharide group C conjugated|0.5 mL, Intramuscular
11994558|NCT00631982|Procedure|in vitro matuartion of oocytes|in vitro maturation of (immature) oocytes
11994559|NCT00631969|Drug|Vardenafil ODT (STAXYN, BAY38-9456)|Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
11994560|NCT00631969|Drug|Placebo|Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
11994561|NCT00631943|Drug|Pregabalin (Lyrica)|Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days.
11994562|NCT00631917|Drug|Aliskiren|Aliskiren 300 mg once a day
11994563|NCT00631917|Drug|Ramipril|Ramipril 10 mg once a day
11994564|NCT00631917|Other|Placebo to Ramipril|Placebo capsules to match ramipril.
11994565|NCT00631917|Other|Placebo to Aliskiren|Placebo tablets to match aliskiren.
11994566|NCT00631878|Drug|Pagibaximab (formerly BSYX-A110)|Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
11994567|NCT00631865|Biological|Melanocyte transplantation|Injection of melanocytes directly in Epidermis
11994568|NCT00631852|Drug|American Ginseng root|four, 250mg tablets daily 5-14 days prior to surgery
11994569|NCT00631839|Radiation|Thoracic 3-D Conformal Radiotherapy|Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies >=6MV.
11994570|NCT00631813|Drug|Prucalopride|0.5 mg bid
11994571|NCT00631813|Drug|Prucalopride|1 mg bid
11994572|NCT00631813|Drug|Prucalopride|2 mg bid
11994573|NCT00631813|Drug|Placebo|bid
11994574|NCT00631800|Drug|Pagibaximab (formerly BSYX-A110)|Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
11994575|NCT00631774|Dietary Supplement|Glucerna SR|Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with exchange-diet plan only will receive a meal plan like they have in the lead-in period.
11994576|NCT00631761|Other|educational workshop|The intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas.
11994577|NCT00631761|Other|no intervention (usual resident activities)|usual activities
11994578|NCT00631748|Drug|quetiapine fumarate|At baseline, subjects in the experimental group will initially be administered 50 mg/day of Seroquel XR™ (extended release formulation of quetiapine fumarate), to be titrated up to 400 mg/day of Seroquel XR™ by the end of the second week. By the end of week 2, subjects will be stabilized on a dose of 400 mg/day or alternatively 300, 200, 100, or 50 mg/day of study drug, as tolerated. If a subject is unable to tolerate the 50 mg/day dose, he or she will be discontinued from the drug portion of the study.
11994579|NCT00631748|Drug|Matched Placebo|Subjects randomized to the placebo comparator group will follow the same titration and dosing procedures as the experimental group, but will receive matched placebo tablets.
11994580|NCT00631748|Behavioral|Cognitive-behavioral Therapy|During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.
11994581|NCT00631722|Drug|Quatiapine Fumarate|600-750mg/day
11994582|NCT00631722|Drug|Haloperidol|12-20mg/day
11994583|NCT00631709|Other|CareLink Remote Monitoring|Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits
11994584|NCT00631696|Drug|Pregabalin|pregabalin 600 mg given twice a day
11994586|NCT00631670|Radiation|Stereotactic Body Radiation Therapy|15 Gy in one treatment
11994587|NCT00631670|Radiation|Stereotactic Body Radiation Therapy|Dose: 70 Gy at 2.8 Gy/treatment
11994588|NCT00631657|Drug|Esmirtazapine|One esmirtazapine 4.5 mg tablet once a day
11994589|NCT00631657|Drug|Placebo|One placebo tablet once a day
11994590|NCT00631631|Drug|Mifamurtide (L-MTP-PE)|Solution for intravenous infusion
11994591|NCT00631618|Drug|Sutent (sunitinib)|The initial dose will be 50mg daily taken for 4 consecutive weeks followed by 2-weeks off to comprise a complete cycle of 6 weeks.
11994592|NCT00631592|Drug|GSK1349572|
11994593|NCT00631579|Drug|Rasburicase (SR29142)|
11994594|NCT00631566|Drug|Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%|"BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).
~pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.
~Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days."
11994595|NCT00631566|Drug|Placebo|Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.
11994596|NCT00631553|Drug|perflutren lipid microspheres|1.3 ml in 30 ml of saline, infused into vein at 2ml / min and titrated for optimal image quality (not to exceed 10 ml/ min at any time).
11994597|NCT00631540|Device|Formula Balloon-Expandable Stent|renal artery stenting
11994598|NCT00631527|Drug|Leuprolide|Injections given through a needle in the muscle every 3 months.
11994599|NCT00631527|Drug|Goserelin|Subcutaneous injections given once every 3 months.
11994600|NCT00631527|Drug|Sunitinib Malate|Starting dose of 12.5 mg by mouth daily for 4 weeks
11994601|NCT00631527|Drug|Casodex|Once a day by mouth for 2 weeks.
11994602|NCT00631527|Radiation|Radiation Therapy (RT)|Radiation treatment once daily over a period of 8 weeks.
11994603|NCT00631514|Drug|acetaminophen|acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
11994604|NCT00631514|Drug|ibuprofen|acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
11994605|NCT00631514|Drug|piroxicam|acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
11994606|NCT00631501|Drug|Placebo|
11994607|NCT00631501|Drug|Doxycycline|
11994608|NCT00631488|Drug|MK-0893|Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).
11994609|NCT00631488|Drug|Sitagliptin|Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
11994610|NCT00631488|Drug|Metformin|Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).
11994611|NCT00631488|Drug|Placebo for MK-0893|Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.
11994612|NCT00631488|Drug|Placebo for Sitagliptin|Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
11994613|NCT00631488|Drug|Placebo for Metformin|Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
11994614|NCT00631475|Drug|Bosentan|"For patients who were administered Bosentan during BUILD 3 (NCT00391443):
~continue on same dose
~For patients who were administered placebo during BUILD 3 (NCT00391443):
~Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.)"
11994615|NCT00631462|Drug|TG101348|Orally administered, once a day, for 28 days, up to 6 cycles.
11994616|NCT00631449|Drug|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines.
11994617|NCT00631449|Drug|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
11994618|NCT00631410|Drug|sunitinib + mFOLFOX6|37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
11994619|NCT00631410|Drug|sunitinib + mFOLFOX6|50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
11994620|NCT00631397|Device|Ultrasound machine|Weekly Bone Density measurements using the Sonometer
11994621|NCT00631384|Behavioral|Couples VCT|Offer women coming to antenatal clinics to have their husbands come with them for couples VCT
11994622|NCT00631384|Behavioral|Individual VCT|Women to receive individual VCT
11994623|NCT00631371|Drug|Bevacizumab|Bevacizumab 10 mg/kg intravenous (IV) q8wks
11994624|NCT00631371|Drug|Temsirolimus|Temsirolimus 25 mg IV weekly
11994625|NCT00631371|Drug|Bevacizumab|Bevacizumab 10 mg/kg intravenous (IV) q8wks
11994626|NCT00631371|Drug|Interferon-Alfa 9MU|Interferon-Alfa 9MU SC TIW
11994627|NCT00631358|Drug|Maxidex|Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily
11994628|NCT00631358|Other|No treatment|Healthy normal control group receiving no treatment
11994652|NCT00631163|Drug|Deferasirox (ICL670)|The recommended initial daily dose of Deferasirox is 20 mg/kg body weight.
11994653|NCT00631150|Drug|Levetiracetam (Keppra)|
11994654|NCT00631137|Drug|testosterone gel applied to skin|Application of testosterone gel
11994655|NCT00631137|Dietary Supplement|whey powder protein|
11994656|NCT00631124|Drug|BAY86-4891 (Estradiol / Drospirenone)|Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
11995394|NCT00625937|Drug|tegafur-gimeracil-oteracil potassium|
11994629|NCT00631345|Behavioral|Group-Based Lifestyle Intervention (Phases 1 and 2)|This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for the first 6-months of treatment (Phase 1) for a total weight loss of 5-7%. During Phase 2 (months 7-24) participants will be encouraged to continue weight loss as long as their BMI does not fall below 20 kg/m2, but the primary focus will be on weight maintenance. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
11994630|NCT00631345|Other|Individual Education Program (All Phases)|Comparison participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the RD will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle and will receive the lifestyle intervention manual and video series at the conclusion of their participation. These participants will be approached about the continuation at 24 months. If they agree to participate, these participants will continue to receive a monthly newsletter and will also receive biannual RD contacts.
11994631|NCT00631345|Behavioral|Self-Directed Maintenance (Phase 3)|Individuals from the lifestyle intervention group in the original HELP PD project who are randomized to self-directed maintenance will receive biannual nutrition counseling from the study RDs. In these sessions, the RD will cover basic aspects of transition from the group maintenance to individual maintenance, answer questions about healthy eating and activity to support weight loss, and discuss existing community resources that may fit the participants' needs as they attempt to maintain their weight loss, physical activity and dietary goals.
11994632|NCT00631345|Behavioral|Extended Group Maintenance (Phase 3)|The extended group maintenance condition will consist of monthly CHW-led group meetings, monthly individual telephone contacts with the CHW, biannual RD contacts, and other contacts as needed. During Phase 3, the objectives for Phase 2 of the initial program will be continued. That is, participants who were successful at weight loss (≥ 7% of initial body weight) are encouraged to either maintain their weight loss or to advance towards their own personal goals. Participants who were not successful are encouraged to problem solve the reasons for lack of success. The groups will focus on maintaining the healthy behaviors that produced weight loss and/or problem solving to overcome barriers to weight loss.
11994633|NCT00631319|Drug|OROS hydromorphone|hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
11994634|NCT00631319|Drug|Placebo|Placebo
11994635|NCT00631293|Dietary Supplement|lactisole|administration of lactisole followed by placebo
11994636|NCT00631293|Other|placebo|administration of placebo followed by lactisole
11994637|NCT00631280|Behavioral|Choice|Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a decision aid. Parent treatment preferences will be elicited and parents will receive coaching in deliberation about striking a balance between benefit and tolerable side effects. Parent will then choose the week that was best for their child and plan their next steps. Parents will also receive a consultation report that contains a physician dosage recommendation.
11994638|NCT00631280|Behavioral|Recommendation|Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a consultation report that also contains a physician dosage recommendation.
11994639|NCT00631267|Procedure|Manual Manipulation|The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.
11994640|NCT00631267|Procedure|Finger Trap Traction|Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.
11994641|NCT00631254|Procedure|Allergen challenge|"Conventional allergen challenge: increasing allergen doses given by nebulisation through the mouth and stopped when a 20% fall in forced expiratory volume in one second is obtained.
~Low dose allergen challenge: very low allergen doses given by nebulisation through the mouth. No more than a 5% fall in forced expiratory volume in one second.
~Nasal allergen challenge: One drop of increasing allergen doses on nasal mucosa."
11994642|NCT00631254|Procedure|Allergen challenge|"Low dose allergen challenge: very low allergen doses given by nebulisation through the mouth. No more than a 5% fall in forced expiratory volume in one second.
~Nasal allergen challenge: One drop of increasing allergen doses on nasal mucosa."
11994643|NCT00631241|Procedure|Single Photon Emission Computed Tomography|First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients.
11994644|NCT00631241|Procedure|Intraoperative Lymphatic Mapping|Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
11994645|NCT00631228|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease
11994646|NCT00631215|Procedure|Hyperbaric oxygen therapy|Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
11994647|NCT00631202|Drug|Epoetin alfa|Patients that will satisfy all inclusion/exclusion criteria will be sequentially treated with three single Epoetin alfa administrations. The first time the dose will be 600U/KG BW s.c. in a single administration. The outcome measures will be assessed. A washout period of 1 month will be necessary to eliminate any carry-over effect. A second administration of 1200U/KG BW s.c. will be performed. Outcome measures will be again assessed.
11994648|NCT00631189|Drug|Rosuvastatin|5mg oral
11994649|NCT00631189|Drug|Pravastatin|40mg oral
11994650|NCT00631189|Drug|Atorvastatin|10mg oral
11994651|NCT00631176|Behavioral|Just-In-Time Training|On-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training. This training will occur before their shift starts before the morning round. This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events. This training will be done with or without high fidelity simulation function.
11995395|NCT00625937|Radiation|radiation therapy|
11994657|NCT00631124|Drug|BAY86-4891 (Estradiol / Drospirenone)|Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
11994658|NCT00631111|Drug|effervescent ibuprofen tablets|
11994659|NCT00631111|Drug|effervescent Aspirin plus Vitamin C tablets|
11994660|NCT00631111|Drug|ibuprofen tablets|
11994661|NCT00631111|Drug|placebo|
11994662|NCT00631098|Procedure|venous cannulation|External jugular and cubital vein cannulation
11994663|NCT00631085|Drug|gamma tocopherol|Maxi Gamma softgels 1200mg QD
11994664|NCT00631072|Biological|INKT|Administered in 3 equal doses by intravenous infusion on days 1, 15 and 29.
11994665|NCT00631072|Drug|GM-CSF|Given subcutaneously once daily for 10 days beginning the second day of the second and third infusion
11994666|NCT00631059|Other|Hem(A)+ Technology|The purpose of the study is to test patients blood. A blood draw will be taken and examined with Hem(A)+ technology.
11994667|NCT00631046|Dietary Supplement|Fish Oil|Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
11994668|NCT00631046|Dietary Supplement|Sunflower Oil|Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
11994669|NCT00631033|Drug|Placebo|
11994670|NCT00631033|Drug|Diazoxide|
11994671|NCT00631033|Drug|Metformin + Diazoxide|
11994672|NCT00631020|Behavioral|CBME|6 weeks of once a week one-on-one CBME
11994673|NCT00631020|Drug|Optional NRT|NicoDerm CQ nicotine transdermal patch
11994674|NCT00631007|Drug|INT131 besylate|Once-daily, oral
11994675|NCT00631007|Drug|Pioglitazone HCl|Once-daily, oral
11994676|NCT00631007|Drug|Placebo|Once-daily, oral
11994677|NCT00630994|Drug|Dacogen|
11994678|NCT00630981|Behavioral|Psychotherapy|Specific psychotherapy for dissociative disorders
11994679|NCT00630981|Drug|Pharmacological treatment (Quetiapine and/or Escitalopram)|Quetiapine for psychotic symptoms/Escitalopram if depressive disorders
11994680|NCT00630968|Drug|Levetiracetam (Keppra)|
11994681|NCT00630955|Drug|memantine|Memantine 20 mg once per day for 7 days
11994682|NCT00630955|Drug|Memantine|Memantine 40 mg once per day for 7 days
11994683|NCT00630955|Drug|Placebo|Placebo once per day for 7 days
11994684|NCT00630942|Drug|Minocycline|Minocycline 100 mg capsules twice a day before breakfast and before dinner.
11994685|NCT00630929|Drug|Ibuprofen|800 mg oral tablet 3 times daily with meals for 6 weeks
11994686|NCT00630929|Drug|Placebo|Matched placebo orally for 6 weeks
11994687|NCT00630929|Drug|Celecoxib|200 mg oral capsule once daily with morning meal for 6 weeks
11994688|NCT00630916|Device|Mitroflow Aortic Heart Valve|Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
11994689|NCT00630903|Drug|PUVA (8MOP + UVA) + IFN|Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)
11994690|NCT00630903|Drug|PUVA (8-MOP + UVA)|Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)
11994691|NCT00630890|Radiation|External beam radiation and Cyberknife radiosurgery boost and capecitabine|External Beam Radiation to 45 Gy Stereotactic Body Radiotherapy with Cyberknife to 20 Gy in 5 fractions dose escalation to 25 Gy in 5 fractions, and then 30 Gy in 5 fractions Capecitabine 825 mg/m2 q12 hours taken orally 5 days per week
11994692|NCT00630877|Drug|Niacin extended-release (NER)|Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
11994693|NCT00630877|Drug|Niacin extended-release (NER) placebo|Tablets administered once daily for 6 weeks
11994694|NCT00630877|Drug|Aspirin (ASA)|Tablets (325 mg) administered once daily for 6 weeks
11994695|NCT00630877|Drug|Aspirin (ASA) placebo|Tablets administered once daily for 6 weeks
11994696|NCT00630864|Drug|Fx-1006A|During Part 1, patients will receive Fx-1006A 20mg soft gelatin capsules once daily (at the same time each day) for two weeks. During Part 2, patients will receive Fx-1006A 20mg soft gelatin capsules once daily to complete a total of 12 months of dosing
11994697|NCT00630851|Drug|Donepezil (Aricept)|Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment
11994698|NCT00630851|Drug|Placebo|Matching placebo tablets orally once daily for 6 months
11994699|NCT00630838|Drug|VSL#3|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
11994700|NCT00630838|Drug|Placebo|Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
11994701|NCT00630825|Drug|LY2189265|
11994702|NCT00630825|Drug|Placebo|
11994703|NCT00630812|Drug|inhaled mannitol|400 mg BD for 26 + 26 weeks
11994704|NCT00630812|Drug|Placebo comparator|BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
11994705|NCT00630799|Drug|leuprolide acetate|17 mg i.m.
11994706|NCT00630786|Drug|Panitumumab|Administered by intravenous infusion
11994707|NCT00630786|Drug|Conatumumab|Administered by intravenous infusion
11994708|NCT00630760|Drug|NRX 194204|NRX 194204 capsules given 3mg/m2 daily x 28 days. Repeated until PD
11994709|NCT00630747|Biological|Idursulfase|Solution for intravenous infusion, 0.5 mg/kg once-weekly
11994710|NCT00630734|Drug|Pravastatin|Pravastatin 40 mg by mouth daily on days 1-4
11994711|NCT00630734|Drug|Darunavir|Darunavir 600mg by mouth twice daily on days 12-18
11994712|NCT00630734|Drug|Ritonavir|Ritonavir 100mg by mouth twice daily on days 12-18
11994713|NCT00630734|Drug|Pravastatin|Pravastatin 40 mg by mouth daily on days 15-18
11994714|NCT00630734|Other|Washout|Washout (no medication) on days 5-11.
11994715|NCT00630721|Other|IFNbeta-1b|no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.
11994716|NCT00630708|Drug|Benazepril|20 mg per day
11994717|NCT00630708|Drug|Losartan|100 mg per day
11994718|NCT00630708|Drug|Benazepril+Losartan|combination treatment of 10 mg benazepril and 50 mg losartan per day
11994719|NCT00630695|Drug|Lanreotide LP 90|Lanreotide LP 90
11994720|NCT00630695|Drug|Placebo lanreotide|Placebo
11994721|NCT00630682|Drug|Dextroamphetamine|1 week placebo and 8 weeks 60mg d-AMP QD.
11994722|NCT00630682|Drug|Placebo|9 weeks of placebo 60mg capsules QD.
11994723|NCT00630669|Procedure|Rubber band ligation|placing rubber bands around the internal hemorrhoids
11994724|NCT00630669|Procedure|Bipolar coagulation|using electricity to cauterize
11994725|NCT00630656|Drug|Talactoferrin alfa|15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
11994726|NCT00630656|Drug|Placebo|Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
11994727|NCT00630643|Biological|NI-0401 (anti-CD3 mAB)|0.05 mg up to 10 mg
11994728|NCT00630643|Drug|Placebo|Placebo
11994729|NCT00630630|Drug|Levetiracetam|
11994730|NCT00630630|Other|Placebo|
11994731|NCT00630617|Behavioral|Diet, Physical activity, Physical inactivity|Community based participatory research design
11994732|NCT00630591|Behavioral|Standardized Materials Group|7 sets of print materials will be mailed every 6-7 weeks. A short survey about the information received and how useful it was will be completed.
11994733|NCT00630591|Behavioral|Independent Tailored Intervention|Personalized notebooks and newsletters of diet and exercise information will be mailed. A short survey about the information received and how useful it was will be completed.
11994734|NCT00630591|Behavioral|Partner-Assisted Tailored Intervention|Daughters and Mothers, as a team, will each receive personalized notebooks and newsletters of diet and exercise information. A short survey about the information received and how useful it was will be completed.
11994735|NCT00630578|Behavioral|Cognitive Processing Therapy|Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.
11994736|NCT00630565|Biological|sargramostim|Given subcutaneously (SC) 10 μg/kg/day from day +3 until apheresis is completed
11994737|NCT00630565|Drug|busulfan|4 mg/kg po in 4 divided doses (.8 mg/kg/dose orally every 6 hours) on days -7 through -4.
11994738|NCT00630565|Drug|cyclophosphamide|4 gm/m^2 x 1 (day 0) and 60 mg/kg intravenous (IV) over 2 hours on days -3 and -2.
11994739|NCT00630565|Drug|dexamethasone|20 mg/m^2 x 4 doses every 12 hours given intravenously (IV) push before cytoxan on day 0 and then every 12 hours
11994740|NCT00630565|Drug|etoposide|300 mg/m^2/day x 2 days (day 0-1) over 3 hours intravenously (IV)
11994741|NCT00630565|Procedure|bone marrow transplantation|Day 0 infusion of bone marrow cells
11994742|NCT00630565|Procedure|hematopoietic stem cell transplantation|Stem cell infusion (>48 hours after the last dose of cyclophosphamide)
11994743|NCT00630565|Procedure|peripheral blood stem cell transplantation|Day 0 infusion of peripheral blood stem cells
11994744|NCT00630565|Radiation|total-body irradiation|165 cGy/dose given twice a day on days -7 through -4.
11994745|NCT00630552|Other|Placebo|Inactive dummy of AMG 655.
11994746|NCT00630552|Drug|AMG 479|AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
11994747|NCT00630552|Drug|AMG 655|AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
11994748|NCT00630539|Drug|Placebo|1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
11994749|NCT00630539|Drug|Ospemifene 5 mg|1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
11994750|NCT00630539|Drug|Ospemifene 15 mg|1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
11994751|NCT00630539|Drug|Ospemifene 30 mg|1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
11994752|NCT00630513|Drug|Ertapenem|3 days regimen with Ertapenem (1 g/day i.v.)
11994753|NCT00630513|Drug|Ampicillin-Sulbactam|3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)
11994754|NCT00630500|Drug|Memantine|Tablets, 5 or 10 mg, twice daily
11994755|NCT00630500|Drug|Placebo|Tablets corresponding to 5 or 10 mg, twice daily, 6 months
11994756|NCT00630487|Drug|Placebo|Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.
11994757|NCT00630487|Drug|Somatropin|Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.
11994758|NCT00630474|Drug|xylometazoline|xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
11994759|NCT00630461|Biological|Clinical Center Reference Endotoxin|single inhalation challenge
11994760|NCT00630435|Drug|Premarin®/MPA formulation A|
11994761|NCT00630435|Drug|Premarin®/MPA formulation B|
11994762|NCT00630435|Drug|Premarin®/MPA formulation C|
11994763|NCT00630435|Drug|Premarin®/MPA currently marketed product|
11994764|NCT00630409|Drug|Gemcitabine|800 mg IV day 1 and 8
11994765|NCT00630409|Drug|Doxil|24 mg/m2 every 21 days IV
11994815|NCT00630058|Drug|MP-424 (L), PEG-IFN-a-2b, RBV|MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
11996235|NCT00620451|Drug|placebo|gelatin capsule
11994766|NCT00630396|Drug|Minocycline|"Dose level 1 = 3mg/kg intravenous (IV) initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses.
~Dose level 2 = 4.5mg/kg intravenous (IV) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses.
~Dose level 3 = 6 mg/kg intravenous (IV) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses.
~Dose level 4 = 10 mg/kg intravenous (IV) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses"
11994767|NCT00630383|Biological|Live Hookworm Larvae|25 live hookworm will be applied to the arm and will infect transdermally. They will be eradicated after 48 weeks.
11994768|NCT00630383|Other|Histamine|0.01% histamine solution is pipetted onto a plaster dressing.
11994769|NCT00630370|Drug|Placebo|2 Placebo tablets, TID, orally, 58 days
11994770|NCT00630370|Drug|20 mg ATI 7505|1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
11994771|NCT00630370|Drug|40 mg ATI 7505|1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
11994772|NCT00630370|Drug|80 mg ATI 7505|2 ATI 40mg tablets, TID, orally, 58 days
11994773|NCT00630357|Drug|Levetiracetam (Keppra)|
11994774|NCT00630344|Drug|RAD001|
11994775|NCT00630344|Drug|Bicalutamide|
11994776|NCT00630331|Biological|Cell culture-derived influenza vaccine|One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
11994777|NCT00630331|Biological|Egg-derived influenza virus vaccine|One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
11994778|NCT00630331|Biological|Placebo|One dose (0.5 mL) of phosphate buffered solution.
11994779|NCT00630318|Device|MRI|15-20 minutes MR imaging
11994780|NCT00630305|Device|alphafilcon A toric|Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
11994781|NCT00630305|Device|lotrafilcon B toric|Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
11994782|NCT00630305|Device|senofilcon A toric|Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
11994783|NCT00630292|Other|Magnetic Resonance Angiography (MRA) of the Breast|Magnetic Resonance Angiography (MRA) of the breast will be performed before or after pre-treatment magnetic resonance imaging (MRI) and then once again before or after the post-treatment MRI.
11994784|NCT00630279|Drug|Placebo|Placebo
11994785|NCT00630279|Drug|Recombinant Microbial Lipase SLV339|oral, 150 mg/d, 7 days treatment
11994786|NCT00630279|Drug|Recombinant Microbial Lipase SLV339|oral, 300 mg/d, 7 days treatment
11994787|NCT00630279|Drug|Recombinant Microbial Lipase SLV339|oral, 600 mg/d, 7 days treatment
11994788|NCT00630266|Device|CorCap CSD|The surgical procedure includes implantation of the CorCap CSD with concommitant mitral valve surgery through a sternotomy.
11994789|NCT00630253|Biological|Anti-Thymocyte Globulin|30 mg/kg/day will be administered after MP on days -6, -5, -4, -3 and -2.
11994790|NCT00630253|Drug|Cyclophosphamide|5 mg/kg is to be given as a 2 hour infusion, Days -6 through -3.
11994791|NCT00630253|Drug|Fludarabine|35 mg/m^2 intravenously (IV) on days -6 through -2.
11994792|NCT00630253|Procedure|Hematopoietic Stem Cell Transplantation|Bone marrow or umbilical cord blood infusion on day 0.
11994793|NCT00630253|Drug|Methylprednisolone|Methylprednisolone (MP) 2 mg/kg/day intravenously every 24 hours will be given from day -6 until day -2 as a premedication for ATG.
11994794|NCT00630253|Drug|Filgrastim|5 mcg/kg per day intravenously (IV) continue until Absolute neutrophil count > or = 2.5 x 10^9/L
11994795|NCT00630253|Drug|Cyclosporine|Cyclosporine IV over 2 hours or orally every 8-12 hours beginning on day -3 and continuing until day 100, followed by a taper.
11994796|NCT00630253|Drug|Mycophenolate Mofetil|Day -3 through day +30 or for 7 days after engraftment, whichever day is later, if no acute GVHD. Engraftment is defined as 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 x 10^9/L. MMF will be given at a dose of 15 mg/kg/dose every 8 hours PO (to a maximum dose of 1 gram).
11994797|NCT00630227|Biological|Biologic Lung Volume Reduction|20 mL Hydrogel
11994798|NCT00630214|Dietary Supplement|Oral calcium plus vitamin D|calcium supplementation took 3 g/day oral calcium (1 g every 8 h) plus 1 mcg/day vitamin D (0.5 mcg every 12 h), beginning on the night of surgery and continuing for 14 days.
11994799|NCT00630214|Dietary Supplement|Oral calcium alone|calcium carbonate (3 g/day, 1 g every 8 h)
11994800|NCT00630201|Drug|Probuphine (buprenorphine implant)|Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
11994801|NCT00630188|Other|You Decide|"For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician
~For Physicians: a one-time educational session on prostate cancer and the value of shared decision making"
11994802|NCT00630188|Other|Reducing Your Risks in the Crash|Publicly available video on highway safety and reducing individual risks in a crash
11994803|NCT00630175|Drug|zolpidem-MR (modified release)|
11994804|NCT00630175|Drug|zolpidem (SL800750)|
11994805|NCT00630175|Drug|placebo|
11994806|NCT00630162|Genetic|amoeba|
11994807|NCT00630149|Drug|Pemetrexed (Alimta)|500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation.
11994808|NCT00630136|Behavioral|interview|The parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed.
11994809|NCT00630110|Drug|docetaxel|docetaxel (75 mg/m2)
11994810|NCT00630110|Drug|NPI-2358 + docetaxel|NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
11994811|NCT00630097|Drug|modafinil|Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.
11994812|NCT00630084|Drug|pegylated interferon alpha 2a and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
11994813|NCT00630084|Drug|pegylated interferon alpha 2a and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
11994814|NCT00630058|Drug|MP-424(H), PEG-IFN-a-2b, RBV|MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
11994907|NCT00629395|Behavioral|Captain's Log Computer Program|12 Computer Program
11994816|NCT00630045|Drug|neoadjuvant chemotherapy with oxaliplatin and capecitabine|oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
11994817|NCT00630045|Procedure|resection of liver metastasis|surgery with the aim of R0 resection
11994818|NCT00630032|Drug|cyclophosphamide|500 mg/m² every 3 weeks
11994819|NCT00630032|Drug|Docetaxel|100 mg/m² every 3 weeks
11994820|NCT00630032|Drug|epirubicin hydrochloride|100 mg/m² every 3 weeks
11994821|NCT00630032|Drug|fluorouracil|500 mg/m² every 3 weeks
11994822|NCT00630032|Drug|ixabepilone|40 mg/m² every 3 weeks
11994823|NCT00630019|Drug|1.5% levofloxacin ophthalmic solution|Topical application
11994824|NCT00630019|Drug|0.5% moxifloxacin hydrochloride ophthalmic solution|Topical application
11994825|NCT00630006|Genetic|TNF-alpha and IL-10|
11994826|NCT00629993|Behavioral|Academic Detailing|It will involve multiple intervention components, some of which are standardized across physicians (i.e., self learning packets, post-tests for CME credit, CD-ROMS, videos, newsletters, culturally sensitive patient education materials, office staff informational sessions, chart and patient reminders, and a general office routine for cervical cancer counseling, including performance feedback, as well as media-ready materials). Academic detailing and the specific office routines will be customized to each physician, although the frequency of the detailing visits will be routinized across all participants, to reduce cost and to maximize its potential for dissemination.
11994827|NCT00629980|Drug|AzaSite®|ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
11994828|NCT00629967|Drug|pegylated interferon alpha 2a and ribavirin|pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks
11994829|NCT00629967|Drug|Pegylated interferon alfa-2a and ribavirin|Pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
11994830|NCT00629941|Drug|AzaSite®|Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
11994831|NCT00629928|Drug|Esomeprazole|20mg oral capsule daily
11994832|NCT00629928|Drug|Esomeprazole|40mg oral capsule daily
11994833|NCT00629928|Drug|Placebo|
11994834|NCT00629889|Drug|levetiracetam|"After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg.
~Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study."
11994835|NCT00629889|Drug|pregabalin|"After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg.
~Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study."
11994836|NCT00629876|Drug|Peginesatide|"Peginesatide 0.075, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225 or 0.25 mg/kg administered subcutaneously every 3 weeks for a total of at least 2 doses. Subsequent injections given every 3 weeks thereafter regardless of the schedule of subsequent chemotherapy cycles.
~Following Study Day 43, subjects may continue on Peginesatide treatment, dosing every 3 weeks until 4 weeks after discontinuation of taxane-containing chemotherapy regimen, the occurrence of a dose limiting toxicity, documented disease progression or change in chemotherapy regimen."
11994837|NCT00629863|Drug|cisplatin|
11994838|NCT00629863|Drug|fluorouracil|
11994839|NCT00629863|Other|questionnaire administration|
11994840|NCT00629863|Procedure|diagnostic endoscopic procedure|
11994841|NCT00629863|Procedure|neoadjuvant therapy|
11994842|NCT00629863|Procedure|quality-of-life assessment|
11994843|NCT00629863|Procedure|therapeutic conventional surgery|
11994844|NCT00629863|Procedure|therapeutic endoscopic surgery|
11994845|NCT00629863|Procedure|ultrasound imaging|
11994846|NCT00629863|Radiation|radiation therapy|
11994847|NCT00629863|Radiation|radioisotope therapy|
11994848|NCT00629850|Device|Powerlung Performer|Inspiratory/Expiratory muscle trainer
11994849|NCT00629837|Biological|Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)|Low dose of BAY 79-4980 [13mg of liposomes/kg] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU).
11994850|NCT00629837|Biological|Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)|High dose of BAY 79-4980 [22mg of liposomes/kg] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU)
11994851|NCT00629837|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 [13mg of liposomes/kg]
11994852|NCT00629837|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to high dose of BAY 79-4980 [22mg of liposomes/kg]
11994853|NCT00629824|Drug|pegylated interferon alpha and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
11994854|NCT00629824|Drug|pegylated interferon alpha and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
11994855|NCT00629824|Drug|pegylated interferon alpha and plus ribavirin|pegylated interferon alpha 180 ug/week and ribavirin 1000-1200 mg/day for 24 weeks
11994856|NCT00629811|Drug|Avotermin (Juvista)|"Intradermal avotermin administered to four wound sites per subject, one wound site per anatomically matched pair, according to the subject's assigned dose group:
~Group 1: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 1)
~Group 2: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 0)
~Each subject received four doses of active drug at concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site, one dose to one wound site per anatomically matched pair of wounds."
11994857|NCT00629811|Drug|Placebo|"Reference therapy was Placebo (vehicle). On Day 0, the four sites randomised to receive Placebo were administered with a 100μL intradermal injection of Placebo.
~Subjects in Group 2 were dosed again on Day 0 at 10 to 30 minutes after wound closure.
~Subjects in Group 1 were dosed again on Day 1 at 24 (+/-4) hours after initial administration of drug."
11994858|NCT00629798|Drug|Busulfan, Melphalan, Fludarabine, Anti-Thymocyte Globulin, Palifermin, Stem cell transplant|Patients will receive Palifermin 60 mcg/kg/day IV on three consecutive days with the last dose administered no less than 24 and no more than 48 hr prior to start of cytoreduction. The preparative regimen to be used for transplants will consist: of busulfan administered in 12 doses over three days of 0.8 mg/kg IV for patients > or = to 4 years of age or 1.0 mg/kg IV for patients < 4 years of age; melphalan 70 mg/m2 IV x 2 days; and, fludarabine 25 mg/m2 IV x 5 days
11994859|NCT00629772|Drug|Placebo|Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20.
11994860|NCT00629772|Drug|Infliximab|Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at weeks 14, 16 and 20.
11994861|NCT00629759|Genetic|JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)|The total dose is divided between 1-3 tumors located within the liver. Patients are treated with JX-594 once every 3 weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments.
11994862|NCT00629746|Device|Medtronic Xomed Nerve Integrity Monitor (NIM)|"patients receive surgery will be intubated with Medtronic Xomed NIM EMG endotracheal tube and the device will be connected to the monitoring system
~The channel leads from the NIM EMG reinforced endotracheal tube were connected to a NIM-response monitor
~A Prass monopolar probe was used in direct contact with the vagus nerve and RLN for laryngeal nerve stimulation.
~The stimuli were generated from the NIM-Response monitor for vagal and RLN stimulation.
~The NIM-response monitor was set to run with a 50 millisecond time window and an amplitude scale at 0.2 mV/division. Event capture was activated with a threshold at 100 μV. Peak to peak amplitudes of evoked EMG activities were directly read on the monitor screen."
11994863|NCT00629733|Drug|RO-14|
11994864|NCT00629720|Drug|alfuzosin (SL770499)|
11994865|NCT00629707|Other|intravenous fluid treatment|infusion of intravenous fluids (0.9% saline and 0.45% saline)
11994866|NCT00629694|Procedure|adenoidectomy, myringotomy, tubes insertion|adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
11994867|NCT00629694|Procedure|A-M|adenoidectomy and myringotomy alone
11994868|NCT00629681|Drug|Pregabalin|Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.
11994869|NCT00629668|Genetic|TNF-alpha and HBV genotype|
11994870|NCT00629668|Other|TNF-alpha and HBV genotypes|
11994871|NCT00629655|Other|motor task, sensory stimulation|"motor task: finger tapping, simple type and complex type
~sensory stimulation: electric or tactile stimulation"
11994872|NCT00629642|Drug|Solifenacin Succinate|Oral, 10mg
11994873|NCT00629642|Drug|Solifenacin Succinate|Oral, 5mg
11994874|NCT00629642|Drug|Oxybutynin Hydrochloride|Oral, 15mg
11994875|NCT00629642|Drug|Placebo|Oral
11994876|NCT00629629|Behavioral|Dietary Advice|
11994877|NCT00629616|Drug|anastrozole|1 mg/day for either 4 months or 6 months depending on the clinical evaluation
11994878|NCT00629616|Drug|fulvestrant|500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation
11994879|NCT00629603|Genetic|cytokine|polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease
11994880|NCT00629603|Genetic|cytokine polymorphisms|Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis
11994881|NCT00629603|Genetic|cytokine polymorphism|fibrosis-relating cytokine polymorphism
11994882|NCT00629590|Drug|AzaSite®|ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days
11994883|NCT00629577|Genetic|microarray analysis|
11994884|NCT00629577|Other|flow cytometry|
11994885|NCT00629577|Procedure|biopsy|
11994886|NCT00629577|Procedure|colposcopy|
11994887|NCT00629564|Drug|Esomeprazole|20mg oral
11994888|NCT00629564|Drug|Esomeprazole|15 minute intravenous infusion
11994889|NCT00629551|Drug|saredutant (SR48968)|oral administration,capsules
11994890|NCT00629551|Drug|paroxetine|oral administration, capsules
11994891|NCT00629551|Drug|placebo|oral administration, capsules
11994892|NCT00629538|Procedure|Therapeutic thoracentesis|Thoracentesis was performed with drainage of 500 ml of pleural fluid first and every 200 ml thereafter until pleural pressure was lower than -20 cm H2O, chest discomfort developed, or no more pleural fluid could be removed.
11994893|NCT00629525|Drug|RAD001|RAD001 at a dose of 10 mg PO daily
11994894|NCT00629512|Drug|Esomeprazole|20mg oral daily
11994895|NCT00629512|Drug|Esomeprazole|40mg oral daily
11994896|NCT00629512|Drug|Placebo|
11994897|NCT00629499|Drug|nab paclitaxel|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)
11994898|NCT00629499|Drug|Cyclophosphamide|600 mg/m2 of IV cyclophosphamide
11994899|NCT00629499|Drug|Trastuzumab|8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.
11994900|NCT00629486|Genetic|Polymorphism of IL-1 beta and TNF-alpha|To analyze the role of polymorphisms of IL-1beta and TNF-alpha gene on risk of hepatitis B-related chronic liver disease and hepatocellular carcinoma
11994901|NCT00629473|Drug|NPI-0052 on Days 1, 8, 15 every 28 days|NPI-0052 dose ranging from 0.1 to 0.9 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 8, and 15 of 4-week cycles
11994902|NCT00629473|Drug|NPI-0052 on Days 1, 4, 8, 11 every 21 days|NPI-0052 dose ranging from 0.075 to 0.6 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 4, 8, and 11 of 3-week cycles
11994903|NCT00629473|Drug|Dexamethasone|20 mg oral or IV day before and day after NPI-0052 dosing.
11994904|NCT00629447|Drug|Innohep|The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.
11994905|NCT00629434|Other|diabetes education via telemedicine|This arm will receive diabetes group education via telemedicine
11994906|NCT00629434|Other|diabetes education in-person|In this arm the group of patients with diabetes will receive diabetes education in-person
11994908|NCT00629382|Device|Polymyxin B immobilized fiber column|Hemoperfusion with PMX will be performed in ICU. The 1st PMX treatment (day 0) will be carried out for 2 hours and ideally within 24 hours but not later than 48 hours after diagnosis of severe sepsis. The second PMX treatment has to be performed 24 to 48 hours after the end of the first PMX treatment, ideally after 24 hours. Hemoperfusion therapy will be performed in addition to conventional medical therapy in the ICU.
11994909|NCT00629382|Other|Conventional medical therapy in the ICU|Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.
11994910|NCT00629369|Device|Extra 3 mouth guard, Shock doctor mouth guard v3.0|Dental mouthguard, molded for each individual patient when in labor. The device is put in the water then in microwave for one minute to soften the device. The device is then applied to the patient's mouth for over 10 seconds to mold it.
11994911|NCT00629356|Genetic|dengue fever|
11994912|NCT00629343|Drug|Azacitidine In Combination With Temozolomide|mg, oral
11994913|NCT00629330|Behavioral|Academic Detailing|Multi-component academic detailing including an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients
11994914|NCT00629317|Other|Moisturizer|Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
11994915|NCT00629317|Drug|Methyl Aminolevulinate|Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
11994916|NCT00629304|Device|placebo|Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.
11994917|NCT00629304|Device|VISITS + PDA-FIT system|patients will have face to face visits at 3 and 6 months + PDA-FIT system
11994918|NCT00629304|Device|PDA-FIT System + telephone follow-up|patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months
11994919|NCT00629278|Biological|trastuzumab|
11994920|NCT00629278|Drug|aromatase inhibition therapy|
11994921|NCT00629278|Drug|cyclophosphamide|
11994922|NCT00629278|Drug|docetaxel|
11994923|NCT00629278|Drug|doxorubicin hydrochloride|
11994924|NCT00629278|Drug|epirubicin hydrochloride|
11994925|NCT00629278|Drug|fluorouracil|
11994926|NCT00629278|Drug|paclitaxel|
11994927|NCT00629278|Drug|releasing hormone agonist therapy|
11994928|NCT00629278|Drug|tamoxifen citrate|
11994929|NCT00629278|Procedure|adjuvant therapy|
11994930|NCT00629278|Radiation|radiation therapy|
11994931|NCT00629265|Device|Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)|NMES or Sham NMES will be paired with repeated, effortful swallowing behavior, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
11994932|NCT00629252|Drug|Sertindole|oral 12-20 mg/day
11994933|NCT00629252|Drug|Risperidone|oral 2-6mg / day
11994934|NCT00629239|Drug|AZD4818|Dry Powder, inhalation, b.i.d., 4 weeks
11994935|NCT00629239|Drug|Placebo|
11994936|NCT00629226|Biological|cetuximab|Given IV
11994937|NCT00629226|Drug|bortezomib|Given IV
11994938|NCT00629226|Drug|cisplatin|Given IV
11994939|NCT00629226|Radiation|intensity-modulated radiation therapy|Once daily, 5 days a week, for up to 8 weeks
11994940|NCT00629213|Drug|acarbose|
11994941|NCT00629213|Drug|placebo|
11994942|NCT00629200|Drug|Sodium Stibogluconate|400 mg/m^2 IV daily on days 1-5.
11994943|NCT00629200|Drug|Interferon Alpha-2b|3x10^6 units subcutaneously three times weekly
11994944|NCT00629187|Drug|Temozolomide|Before taking part in this study, subjects will have stem cells collected in a procedure called apheresis. Once on this study, subjects will be admitted to the hospital and receive daily doses of temozolomide by mouth for 5 days. Stem cells will be given back to subjects who will remain in the hospital until blood counts have recovered. Doses of temozolomide will range from 350 mg to 1500 mg/m(squared) daily for 5 days (total dose 1750 to 7500 mg/m(squared).
11994945|NCT00629174|Behavioral|Exercise|Endurance and resistence training, 90 minutes, 3 times weekly
11994946|NCT00629174|Behavioral|Mental activity|Participation at computer lessons, 3 times weekly, 90 minutes each
11994947|NCT00629161|Drug|Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)|12 months period of Traditional Chinese Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
11994948|NCT00629161|Drug|placebo|12 months period of placebo plus 1 month period without placebo
11994949|NCT00629148|Drug|Vinorelbine and Capecitabine|Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w
11994950|NCT00629148|Drug|Vinorelbine and Capecitabine|Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w
11994951|NCT00629135|Drug|Moxifloxacin/Metronidazole or Piperacillin/Tazobactam|Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
11994952|NCT00629122|Drug|Tacrolimus (Arm B)|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and clotrimazole troche x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, clotrimazole); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and clotrimazole troche x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subject by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
11994983|NCT00628914|Drug|Escitalopram, eszopiclone, and placebo|Escitalopram 10mg tabs QD for 8 weeks; Eszopiclone 3mg tabs QD for initial 4 weeks then placebo tabs QD for final 4 weeks
11994953|NCT00629122|Drug|Clotrimazole Troche|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and clotrimazole troche x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, clotrimazole); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and clotrimazole troche x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subject by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
11994954|NCT00629122|Drug|Tacrolimus (Arm A)|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and nystatin suspension x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, nystatin); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and nystatin suspension x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subjects by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
11994955|NCT00629122|Drug|Nystatin Suspension|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and nystatin suspension x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, nystatin); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and nystatin suspension x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subjects by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
11994956|NCT00629096|Procedure|Intracoronary infusion of autologous bone marrow cells|Autologous mononuclear bone marrow cells will be administered by intracoronary infusion via a percutaneous catheter
11994957|NCT00629083|Device|Bulkamid|Bulking injection with Bulkamid injection device
11994958|NCT00629083|Device|Contigen|Transurethral bulking injection
11994959|NCT00629070|Other|Traditional strength training|Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise)at 30 degrees/second; 6 sets of 5 maximum-effort concentric actions
11994960|NCT00629070|Other|Velocity-enhanced training|Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise). Subjects will perform 2 sets of 5 concentric exertions at 30°/second. The following 4 sets of 5 repetitions will be performed at a faster speed, starting at 60° /second. The velocity will be increased weekly in 15° /second increments up to a maximum of 120°/second.
11994961|NCT00629057|Biological|MVA-BN-PRO|1x10e8 TCID50 q 4 wks x 6
11994962|NCT00629057|Biological|MVA-BN-PRO|2 x 10e8 TCID50 q 4 wks x 6
11994963|NCT00629057|Biological|MVA-BN-PRO|4 x 10e8 TCID50 q 4 wks x 6
11994964|NCT00629044|Biological|Assessing the blood level of cholesterol 24 S Hydroxylase|Comparison of venous blood level of Cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma and AMD and in healthy subjects.
11994965|NCT00629044|Biological|Assessing the blood level of cholesterol 24 S hydroxylase|Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma, AMD end in healthy subjects
11994966|NCT00629044|Biological|assessing the blood level of cholesterol 24 S hydroxylase|Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with glaucoma, AMD and in healthy subjects
11994967|NCT00629031|Drug|Paromomycin|11 mg/kg for 14 days
11994968|NCT00629031|Drug|Paromomycin|Paromomycin for 21 days @ 11mg/kg by intramuscular injections
11994969|NCT00629018|Biological|CD34+ autologous stem cell transplantation|Peripheral blood stem cells will be mobilized by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labeled with technetium. Patients will undergo myocardial perfusion scintigraphy for myocardial viability assessment and the collected CD34+ cells will be injected intracoronary in the artery supplying the segments of reduced tracer accumulation
11994970|NCT00629018|Drug|Bone Marrow Stimulation|Patients will undergo filgrastim stimulation and viability assessment using the same protocol as in Arm 1. However, in this group, no intracoronary stem cell delivery will be performed; the patients will receive placebo (saline).
11994971|NCT00629018|Biological|SC therapy|In the SC group, CD34+ cells were mobilized by granulocyte colony-stimulating factor and collected via apheresis. Patients underwent myocardial scintigraphy and cells were injected in the artery supplying segments with the greatest perfusion defect
11994972|NCT00629005|Behavioral|Constraint-Induced Movement Therapy + strength training|Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises
11994973|NCT00629005|Behavioral|Constraint-Induced Movement Therapy + range of motion|Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for
11994974|NCT00628992|Other|No specific intervention, standard therapy serving as a control group, passive mobilization of the legs|Muscular rehabilitation of the leg
11994975|NCT00628992|Other|Electrical stimulation of the thigh|Muscular rehabilitation of the leg
11994976|NCT00628992|Other|Cycloergometer training|Muscular rehabilitation of the leg
11994977|NCT00628992|Other|Electrical stimulation of the thigh and cycloergometer training|Muscular rehabilitation of the leg
11994978|NCT00628979|Behavioral|CBT|cognitive- behavioral treatment for panic disorder.
11994979|NCT00628953|Drug|Esomeprazole|40mg twice a day
11994980|NCT00628953|Drug|Placebo|40mg twice a day
11994981|NCT00628940|Radiation|PET images with 18F-fluoromethylcholine|sequential PET images with 18F-fluoromethylcholine
11994982|NCT00628914|Drug|escitalopram and eszopiclone|escitalopram 10mg tabs QD and eszopiclone 3 mg tabs QD for 8 weeks
11995144|NCT00627666|Biological|anti-thymocyte globulin|
11994984|NCT00628914|Drug|Escitalopram|Escitalopram 10mg tabs QD and placebo tabs QD for 8 weeks
11994985|NCT00628901|Procedure|Uterine Fibroid Embolization (UFE)|Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.
11994986|NCT00628901|Device|Contour SE™ Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
11994987|NCT00628901|Device|Embosphere® Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
11994988|NCT00628888|Behavioral|Unified Protocol for Adolescents (UP-A)|All participants will be offered the UP-A intervention, inclusive of 8 and 21 weekly sessions of an emotion-focused treatment with cognitive-behavioral elements, either immediately following randomization or after an 8-week delayed treatment waitlist. The UP-A sessions are delivered in a flexible manner. Several of the UP-A's treatment elements are fixed and received by all participants (psychoeducation about emotions and emotional behavior, awareness and mindfulness skills, antecedent cognitive reappraisal/problem-solving skills, emotion exposure strategies, and relapse prevention skills), although applied for varying numbers of sessions depending on clinical need. Other strategies (motivational enhancement, parenting strategies and crisis management strategies) are applied on an as-needed basis based on client needs.
11994989|NCT00628862|Drug|Formoterol Turbuhaler® 4.5mg|4.5 mg inhaled twice daily
11994990|NCT00628862|Drug|Formoterol Turbuhaler® 9 mg|9 mg inhaled twice daily
11994991|NCT00628862|Drug|Turbuhaler® placebo|placebo inhaled twice daily
11994992|NCT00628836|Device|BION stimulation|"The study will have two phases, each with a six week duration. During phase 1, the BION group will be implanted with BIONs in the middle deltoid and supraspinatus muscles. The muscles will be stimulated electrically by way of the BION and an external controller for one to two hours per day at 5pps in an on-off duty cycle train. The SE group will begin surface stimulation similar to that of BE group.
~Subjects in either group whose initial therapy in phase 1 successfully reduces the amount of shoulder subluxation to 5mm or less will go off stimulation for six weeks, and be reassessed whether subluxation is redeveloping.
~If a subject in either group does not respond sufficiently to phase 1 therapy, the participant will move to phase 2 where the shoulder will be stimulated at up to 25 pps either with surface stimulation (SE group) or BION stimulation (BE group) for another six weeks. At the end of phase 2, participants will go off stimulation for six weeks and then be reevaluated."
11994993|NCT00628823|Dietary Supplement|Gluten-free diet|Gluten containing foods removed from diet
11994994|NCT00628810|Biological|bevacizumab|
11994995|NCT00628810|Drug|fluorouracil|
11994996|NCT00628810|Drug|irinotecan hydrochloride|
11994997|NCT00628810|Drug|leucovorin calcium|
11994998|NCT00628797|Radiation|UVA1|intraindividual half body irradiation
11994999|NCT00628797|Other|UVA1|60 J/cm2 at least 36 tx
11995000|NCT00628784|Procedure|Endoscopic spray cryotherapy|A special orogastric venting tube is passed alongside the endoscope and the cryocatheter then used to perform cryotherapy. Liquid nitrogen is sprayed through the catheter to achieve a uniform white frost in a hemicircumferential sector for 10 seconds. A thaw time of 45-60seconds is observed. This freeze-thaw cycle is repeated x 3 for a total of 40sec cryotherapy per segment. This therapy is repeated every 6 weeks until visible re-epithelialization is seen or a maximum of 6 sessions. Once a squamous lining is seen, biopsies are taken throughout the original area to assess for buried Barretts. If none is seen, followup with 4 quadrant q2cm biopsies are taken at 3,6,9,12, 18, 24, 36, 48 months.
11995001|NCT00628784|Procedure|Endoscopic spray cryotherapy|After passing a special orogastric venting tube, the cryocatheter is used to spray liquid nitrogen onto the tumor to achieve a white frost (frozen state) for 20 seconds. A 45-60 sec thaw is allowed and then retreatment x 2 for a total of 60 seconds therapy per session. Repeat treatments are permitted every 2 weeks for a maximum of 8 treatments.
11995002|NCT00628771|Behavioral|CenteringPregnancy Plus (CP+)|The CenteringPregnancy model of group prenatal care involves skill-building in the areas of efficacy, risk assessment, negotiation, and prevention. CP+ integrates HIV prevention into prenatal care, builds on motivations for healthy pregnancy, and creates a sustainable model via reimbursement mechanisms for prenatal care. There will be ten 2-hour prenatal group sessions.
11995003|NCT00628771|Behavioral|Usual care|Usual care includes standard individual prenatal care and no prenatal group sessions.
11995004|NCT00628758|Drug|Symbicort TBH - Turbuhaler|Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
11995005|NCT00628758|Drug|beta-II-agonist, inhale steroid|Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
11995006|NCT00628745|Other|None. Observational Study.|
11995007|NCT00628732|Drug|Cyclophosphamide and Topotecan|Two courses of cyclophosphamide at 50 mg/m2/dose and topotecan 0.8 mg/m2/dose by mouth every morning for 14 days each.
11995008|NCT00628719|Drug|Liposomal Amphotericin B|a single dose of 10 mg/kg of liposomal amphotericin B
11995009|NCT00628719|Drug|amphotericin B deoxycholate|amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
11995010|NCT00628706|Drug|Delta9-tetrahydrocannabinol (THC)|inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer
11995011|NCT00628680|Device|AAT-023 solution (Zuragen)|Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
11995012|NCT00628680|Drug|Heparin|Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.
11995013|NCT00628667|Drug|Esomeprazole|40mg orally twice daily
11995014|NCT00628667|Drug|Placebo|
11995015|NCT00628628|Drug|As Needed Rasburicase|.15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
11995145|NCT00627666|Drug|busulfan|
11995016|NCT00628628|Drug|Fixed Dose Rasburicase|.15 mg/kg IV Over 30 Minutes Daily
11995017|NCT00628602|Device|BION|"30 patients operated will be randomized into 2 equal groups, a BION Therapy Group (Rx group) and a Control Group (Control group)."
11995018|NCT00628589|Drug|Inhaled loxapine 5 mg|Inhaled loxapine 5 mg
11995019|NCT00628589|Drug|Inhaled loxapine 10 mg|Inhaled loxapine 10 mg
11995020|NCT00628589|Drug|Inhaled placebo|Inhaled placebo
11995021|NCT00628576|Drug|unfractionated heparin|UFH: Continuous i.v. infusion 100 IU/kg/4hrs initially and then adjusted to maintain APTT value 1.5 - 2.5 the pre-treatment value
11995022|NCT00628576|Drug|Tinzaparin (Leo)|FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
11995023|NCT00628550|Drug|Vasopressin|One dose of vasopressin (0.8 units/kg) intravenously rescue as the second vasopressor medication.
11995024|NCT00628550|Drug|Epinephrine|One standard dose epinephrine (0.01 mg/kg) intravenously rescue as the second vasopressor medication.
11995025|NCT00628537|Device|BION stimulation|"BION™ Experimental Group
~The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion.
~Surface Stimulation Group
~Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation.
~Control Group with conservative therapy (Range of motion exercises)
~The research participant is instructed in self-administered, standard range of motion stretching exercises."
11995026|NCT00628511|Device|ARES (Apnea Risk Evaluation System)|application of portable monitoring device with PSG
11995027|NCT00628498|Drug|Defibrotide|"Defibrotide is a single-stranded polydeoxyribonucleotide derived from porcine intestinal mucosa by controlled depolymerisation. Defibrotide has a complex mechanism of action with antithrombotic, anti-ischemic, anti-inflammatory, anti-adhesive and thrombolytic properties but no significant systemic anti-coagulant effects.
~Defibrotide is dose intravenously as a 2-hour infusion every 6 hours at a dose of 25 mg/kg/day. Recommended duration of therapy is 21 days."
11995028|NCT00628498|Drug|Defibrotide|
11995029|NCT00628485|Device|BION|"The second group will have a High Stimulation paradigm at a frequency that produces strong, fused contractions (20-30pps) for a total of 1h/d, also in two spaced sessions. Stimulation intensity will be adjusted to produce the strongest contractions that are tolerated."
11995030|NCT00628485|Device|BION|"The first group will have a stimulation paradigm employing low-frequency (1-5 pps), supramaximal twitch stimulation. The period of the stimulation will probably be short for the first sessions as the muscles gain strength and fatigue resistance, but will eventually be 60 minutes per day in two spaced sessions of about 30 minutes each."
11995031|NCT00628485|Device|BION|A third group of experimental subjects will have a standardized program of voluntary swallowing exercises. Their BIONs will not be activated until they have worsening of dysphagia, and thus are considered to have failed conventional therapy.
11995032|NCT00628472|Drug|botulinum type a|12 Units total were injected into 6 sites in the glabellar complex to determine if injecting through the follicle versus a traditional approach would decrease patient discomfort
11995033|NCT00628459|Dietary Supplement|micronutrient supplementation|Supplements are given daily, 5days/week, for 6 months, involving 15 mg iron (arm 1), 15 mg iron and 10 mg zinc (arm 2), or multiple micronutrient (arm 3): 15 mg iron, 10 mg zinc, 375 µg vitamin A, 5 µg vitamin D, 6 mg vitamin E, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 6 mg niacin, 150 µg folic acid, 0.5 mg vitamin B6, 0.9 mg vitamin B12, 35 mg vitamin C, 10 µg vitamin K, 50 µg iodine, 0.6 mg copper.
11995034|NCT00628433|Drug|Placebo|Placebo
11995035|NCT00628433|Drug|HE3286|daily for 28 days
11995036|NCT00628420|Drug|ACP-104|25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks
11995037|NCT00628420|Drug|ACP-104|Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks
11995038|NCT00628420|Drug|Placebo|patients will be given a placebo: 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg, 200mg, 225mg, 250mg, 275mg, or 300mg (to match the doses given) daily for 2 weeks.
11995039|NCT00628394|Drug|Atomoxetine|40mg 2po qam
11995040|NCT00628394|Drug|Placebo|40mg 2po qam
11995041|NCT00628381|Dietary Supplement|L-citrulline supplementation|L-citrulline, 1.8micromol/kg/min, during 8 hours continuously supplemented
11995042|NCT00628381|Dietary Supplement|L-alanine|L-alanine enteral infusion, isocaloric dosage (3.6 micromol/kg/min), during 8 hours, continuously supplemented
11995043|NCT00628368|Genetic|gene expression analysis|
11995044|NCT00628368|Genetic|mutation analysis|
11995045|NCT00628368|Genetic|polymorphism analysis|
11995046|NCT00628368|Other|laboratory biomarker analysis|
11995047|NCT00628368|Procedure|biopsy|
11995048|NCT00628368|Procedure|endoscopic biopsy|
11995049|NCT00628355|Drug|lidocaine|Women randomized for this treatment was submitted to 2mL of lidocaine 0,5% without vasoconstrictor, directly and perpendicularly on trigger point. Patients received lidocaine injections once a week for 4 weeks
11995050|NCT00628355|Procedure|Ischemic compression|Women randomized for treatment with ischemic compression will be first subjected to transcutaneal electrostimulation(TENS) for 30 minutes on trigger point to inhibit the painful stimulation. For this will be used 100 Hertz of frequency and pulse of 250ms. The intensity will be varying according the painful threshold of each patient. After, the ischemic compression will be applied. For this we will use an algometer to get maximum of homogeneity on therapy. The pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. The therapy will be applied in trigger point three times (60 seconds each) with 30 seconds of rest between the applications.
11995051|NCT00628342|Drug|Esomeprazole|20mg Oral tablet once daily
11995052|NCT00628342|Drug|Esomeprazole|40mg Oral tablet once daily
11995053|NCT00628342|Drug|Placebo|Oral once daily
11995054|NCT00628316|Dietary Supplement|caffeine|caffeine daily intake will be reduced form 150 ml per day
11995055|NCT00628303|Biological|Motavizumab|15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
11995146|NCT00627666|Drug|fludarabine phosphate|
11995056|NCT00628303|Other|Placebo|15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
11995057|NCT00628290|Drug|Cannabidiol|Capsules, 3 times daily, 200 mg, 4 weeks
11995058|NCT00628290|Drug|Amisulpride|Capsules, 3 times daily, 200 mg, 4 weeks
11995059|NCT00628277|Behavioral|high caloric expenditure exercise|high caloric expenditure exercise plus dietary counseling
11995060|NCT00628277|Behavioral|low caloric expenditure exercise plus dietary counseling|low caloric expenditure exercise plus dietary counseling
11995061|NCT00628264|Drug|AP214|Three AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
11995062|NCT00628264|Drug|Placebo|Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
11995063|NCT00628251|Drug|AZD2281|400mg Oral twice daily
11995064|NCT00628251|Drug|Liposomal Doxorubicin|50mg/m2 Monthly Intravenous
11995065|NCT00628251|Drug|AZD2281|200mg oral twice daily
11995066|NCT00628238|Drug|Lenalidomide and Rituximab|Lenalidomide starting at a low dose and escalated based on patient tolerability 21 days of every cycle. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles. Each patient may receive up to a maximum of 7 cycles of treatment if no progressive disease or significant toxicity.
11995067|NCT00628238|Drug|Lenalidomide and Rituximab|Lenalidomide starting at a low dose and escalated based on patient tolerability 21 days of every cycle. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles. Each patient may receive up to a maximum of 7 cycles of treatment if no progressive disease or significant toxicity.
11995068|NCT00628225|Behavioral|Counseling and Nicotine replacement (CN)|"Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. General practitioners were encouraged to advise nicotine replacement.
~Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement."
11995069|NCT00628225|Behavioral|Counseling, Nicotine replacement and Bupropion (CNB)|"Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. The general practitioner was encouraged to advice the patients to use both nicotine replacements and Bupropion-SR.
~Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement and Bupropion-SR."
11995070|NCT00628212|Drug|Teneligliptin 10mg|
11995071|NCT00628212|Drug|Teneligliptin 20 mg|
11995072|NCT00628212|Drug|Teneligliptin 40 mg|
11995073|NCT00628212|Drug|Placebo|
11995074|NCT00628199|Procedure|Improving the scientific process of human cell reprogramming|
11995075|NCT00628186|Device|external drainage tube [polyethylene pancreatic drainage tube]|External drainage tube was intubated with a 5F polyethylene pancreatic drainage tube with a small knob (Sumitomo Bakelite Co., Japan)(MD41515) across pancreaticojejunostomy in pancreaticoduodenectomy, and exteriorized through the jejunal limb.
11995076|NCT00628186|Device|internal drainage tube [polyethylene pancreatic drainage tube]|Internal drainage tube was intubated 5cm length of stent tube cut a 5F polyethylene pancreatic drainage tube with a small knob across pancreaticojejunostomy in pancreaticoduodenectomy, and pancreatic juice was led to reconstructed jejunum.
11995077|NCT00628173|Procedure|AGV implantation|
11995078|NCT00628160|Drug|Terlipressin|Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.
11995079|NCT00628160|Drug|alpha adrenergic drugs|Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
11995080|NCT00628147|Device|Narrow band imaging colonoscope|Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
11995081|NCT00628134|Drug|calfactant|single inhaled dose by nebulizer
11995082|NCT00628134|Drug|isotonic saline|single inhaled dose by nebulizer
11995083|NCT00628121|Drug|Cetrorelix|1, 2 or 3mg, subcutaneouly dosed with single dose
11995084|NCT00628108|Drug|Levocetirizine 1.25 mg|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
11995085|NCT00628108|Other|Placebo|Placebo oral liquid once a day for two weeks
11995086|NCT00628095|Drug|CE-224,535|500 mg po BID
11995087|NCT00628095|Drug|Placebo|no active ingredient
11995088|NCT00628056|Drug|Perhexiline|Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks
11995089|NCT00628043|Drug|epoetin beta|Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
11995090|NCT00628043|Drug|placebo|Subcutaneous administration of placebo once-weekly for 12 weeks
11995091|NCT00628030|Behavioral|NOURISH|Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
11995092|NCT00628030|Other|Wellness Group|Participants in the Wellness Group will have one face-to-face group meeting and information regarding healthy eating and physical activity will be provided on a regular basis via mail.
11995093|NCT00628017|Dietary Supplement|omega-3 polyunsaturated fatty acids ( EPA+DHA)|Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.
11995094|NCT00628004|Device|Biatain Ibu|Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
11995147|NCT00627666|Drug|leucovorin calcium|
11995095|NCT00628004|Device|Local best practice|"N/A - since intervention is local best practice"
11995096|NCT00627991|Drug|Valsartan|
11995097|NCT00627978|Drug|ixabepilone|ixabepilone 40 mg/m2 Q3w over 3 hours
11995098|NCT00627965|Drug|Sildenafil citrate|50mg tds
11995099|NCT00627965|Drug|Placebo|Placebo tds
11995100|NCT00627952|Drug|amlodipine 10 mg|amlodipine 10 mg once daily
11995101|NCT00627952|Drug|manidipine 20 mg|manidipine 20 mg once daily
11995102|NCT00627952|Drug|amlodipine 5 mg + delapril 30 mg|amlodipine 5 mg + delapril 30 mg once daily
11995103|NCT00627952|Drug|manidipine 10 mg + delapril 30 mg|manidipine 10 mg + delapril 30 mg once daily
11995104|NCT00627926|Biological|Pegylated Interferon Alfa 2a|subcutaneous injection, 180 micrograms once per week
11995105|NCT00627926|Drug|Telaprevir|375 mg tablets administered orally every 8 hours at a dose of 750 mg
11995106|NCT00627926|Drug|Ribavirin|200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg
11995107|NCT00627926|Other|Placebo|Telaprevir matching placebo
11995108|NCT00627913|Procedure|Healon 5 injection|Healon 5 (2.3% Sodium hyaluronate) ophthalmic viscoelastic device will be injected into the anterior chamber as needed for pupillary dilation and adequate cataract extraction with intraocular lens placement.
11995109|NCT00627913|Procedure|Retrobulbar anesthetic injection|3-4cc of anesthetic (1% lidocaine/0.75% bupivicaine) will be injected with a 25 gauge needle into the extraocular muscle cone prior to patient and microscope positioning. Cataract extraction with intraocular lens placement will then proceed in standard fashion.
11995110|NCT00627900|Device|bare metal stent|implantation of a bare metal stent
11995111|NCT00627900|Device|Cypher-Stent (Implantation of a sirolimus-eluting stent)|Implantation of a sirolimus-eluting stent
11995112|NCT00627887|Procedure|Electroconvulsive therapy|unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
11995113|NCT00627887|Drug|venlafaxine|extended release target dose of 300mg/day duration of one year
11995114|NCT00627887|Drug|Lithium|serum concentration 0,5-0,8 mmol/L, one year duration
11995115|NCT00627874|Device|+3D Lenses|wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
11995116|NCT00627861|Drug|Aliskiren|150mg orally daily for 6 weeks. Dose may increase to 300mg orally daily dependent upon blood pressure parameters set by the protocol.
11995117|NCT00627861|Drug|Extended-release metoprolol|50mg orally daily for 1 week, dose will increase to 100mg orally daily or decrease to 25mg daily for a second week dependent upon blood pressure parameters set by the protocol. Subjects will take metoprolol for a total of 2 weeks, then be tapered off of it over 5-7 days.
11995118|NCT00627848|Drug|rivastigmine|Acute dose 3 mg or placebo. Thereafter 1.5 mg x 2 ad 30 days and thereafter increasing the dose upto 4.5 mg x 2 according to instructions.
11995119|NCT00627835|Drug|sorafenib|Cohort 1 - sorafenib 200 mg PO bid concurrent with radiation
11995120|NCT00627835|Drug|sorafenib|o Cohort 2 - sorafenib 400 mg PO bid concurrent with radiation
11995121|NCT00627835|Drug|sorafenib and cisplatin|Cohort 3 - sorafenib 200 mg PO bid / cisplatin 75 mg/m2 weeks 1, 4 and 7
11995122|NCT00627835|Drug|sorafenib and cisplatin|o Cohort 4 - sorafenib 400 mg PO bid/ cisplatin 75 mg/m2 weeks 1, 4 and 7
11995123|NCT00627835|Drug|sorafenib and cisplatin|Cohort 5 - sorafenib 400 mg PO bid/ cisplatin 100 mg/m2 weeks 1, 4 and 7
11995124|NCT00627809|Drug|Streptokinase|intracoronary infusion, 250.000 Units
11995125|NCT00627809|Procedure|primary percutaneous coronary intervention|balloon catheter, stent
11995126|NCT00627796|Drug|Lanreotide-Autogel 120 mg|ATG120 mg is given as deep subcutaneous injection into the buttock. Each patient receives one deep subcutaneous injection of ATG120 mg at Visit 1 (V1) and subsequent injection every 4 weeks for 3 injections. Based on GH levels, the dosing interval has been determined as follows: if GH levels were > 2.5 mcg/l, ATG 120 mg is given every 4 weeks while if they were < 2.5 mcg/l ATG 120 mg is administered every 6 weeks for another 3 injections. Afterwards, the dose is maintained as above except in patients with GH levels <1 mcg/l receiving ATG 120 mg every 8 weeks. The estimated duration of treatment is 48-52 weeks according with dose titration.
11995127|NCT00627783|Other|a bicycle exercise test|
11995128|NCT00627770|Device|bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia|edema evaluation using bioimpedance
11995129|NCT00627744|Drug|Sitagliptin|BE 1 receives Placebo tablets od during 12 weeks BE 2 receives Sitagliptin tablets 100 mg od during 12 weeks
11995130|NCT00627731|Drug|methylprednisolone sodium succinate (mPSL)|mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days
11995131|NCT00627731|Drug|prednisolone (PSL)|PSL 40 mg per day for 10 days
11995132|NCT00627718|Device|HRT screening for macula edema|HRT screening for macula edema at time of initial diagnosis of macular degeneration
11995133|NCT00627705|Drug|N-Acetyl Cysteine|"Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
~Entire intervention lasts for 12 weeks (drug administration is continuous)."
11995134|NCT00627705|Other|Placebo - sugar pill|"Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
~Entire intervention lasts for 12 weeks (drug administration is continuous)."
11995135|NCT00627692|Drug|Prucalopride|0.5 mg o.d.
11995136|NCT00627692|Other|Placebo|o.d.
11995137|NCT00627692|Drug|Prucalopride|1 mg o.d.
11995138|NCT00627692|Drug|Prucalopride|2 mg o.d.
11995139|NCT00627692|Drug|Prucalopride|4 mg o.d.
11995140|NCT00627679|Drug|Budesonide Inhalation Suspension|Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
11995141|NCT00627679|Drug|MAP0010 low dose|Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
11995142|NCT00627679|Drug|MAP0010 intermediate dose|Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
11995143|NCT00627679|Drug|MAP0010 high dose|Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
11995148|NCT00627666|Drug|methotrexate|
11995150|NCT00627666|Procedure|allogeneic hematopoietic stem cell transplantation|
11995151|NCT00627666|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
11995152|NCT00627653|Drug|fenofibrate|148mg daily for 30 days
11995153|NCT00627640|Drug|Safinimide 50-100 mg/day|Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
11995154|NCT00627640|Drug|Matching Placebo|Matching Placebo
11995155|NCT00627627|Drug|IPI-504|dose of 400 mg/m2 as a 30-60 minute IV infusion as part of a 21-day treatment cycle
11995156|NCT00627614|Other|breast imaging study|"1. A set of vibro-acoustography (VA) scans will be taken of the breast by an experimental vibro-acoustography device that uses ultrasound for imaging.
~2- An ultrasound scan (sonography) of the breast using a clinical ultrasound machine may be taken during the procedure."
11995157|NCT00627588|Biological|ProSavin|ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
11995158|NCT00627588|Biological|ProSavin|ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
11995159|NCT00627575|Drug|lamotrigine|Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.
11995160|NCT00627575|Drug|atorvastatin|Atorvastatin will available as 40 mg tablets.
11995161|NCT00627575|Drug|phenytoin|Phenytoin will available as 100 mg capsules.
11995162|NCT00627562|Device|robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System|Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System
11995163|NCT00627549|Procedure|Avaulta (surgical procedure using a mesh implant)|The use of Avaulta
11995164|NCT00627549|Procedure|Conventional surgery (anterior repair)|Anterior repair surgery
11995165|NCT00627536|Drug|Avotermin|A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
11995166|NCT00627536|Drug|Placebo|Matched to avotermin dosage strength
11995167|NCT00627523|Drug|Genotropin (PN-180,307) Somatropin|Injectable Genotropin
11995168|NCT00627523|Drug|Control-no treatment|Control-no treatment
11995169|NCT00627510|Other|Routine psychiatric inpatient treatment|Routine psychiatric inpatient treatment. This is not an interventional study.
11995170|NCT00627497|Procedure|Single-Level Posterior Decompression|The single level posterior decompression is a posterior surgical procedure.
11995171|NCT00627497|Device|DIAM Spinal Stabilization|The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.
11995172|NCT00627497|Device|DIAM Spinal Stabilization|The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
11995173|NCT00627497|Device|Fusion|Posterolateral Interbody Fusion
11995174|NCT00627484|Procedure|Gastric bypass|NOTE: the surgery is not paid for by the study
11995175|NCT00627484|Procedure|Gastric banding|NOTE: the surgery is not paid for by the study
11995176|NCT00627484|Procedure|Sleeve gastrectomy|NOTE: the surgery is not paid for by the study
11995177|NCT00627484|Behavioral|Very low calorie diet|Weight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.
11995178|NCT00627471|Drug|Insulin Glargine|For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.
11995179|NCT00627471|Drug|Insulin Glargine|"In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician.
~For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic."
11995180|NCT00627458|Biological|Infanrix Hexa|Vaccine administered as a booster dose at 16-20 months of age
11995181|NCT00627445|Drug|biphasic insulin aspart 30|Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
11995182|NCT00627445|Drug|metformin|Tablets, 500 - 2000 mg, once, twice or three times daily
11995183|NCT00627445|Drug|biphasic insulin aspart 50|Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
11995184|NCT00627432|Drug|gemcitabine hydrochloride|
11995185|NCT00627432|Drug|oxaliplatin|
11995186|NCT00627419|Drug|IPI-504|Dose as a 30 to 60 minute IV infusion as part of a 21-day treatment cycle until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for patient withdrawal. IPI-504 will be administered twice weekly on Study Days 1, 4, 8, and 11 of each 21-day cycle.
11995187|NCT00627406|Drug|Buserelin and Pregnyl|Subcutaneous injection 0.5 mg and 1500 IU
11995188|NCT00627406|Drug|Pregnyl|Subcutaneous injection 5000 IU
11995189|NCT00627406|Drug|Buserelin and Pregnyl|Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
11995190|NCT00627406|Drug|Pregnyl|Subcutaneous injection 5000 IU
11995191|NCT00627393|Drug|Standard antimicrobial therapy|Antimicrobial therapy is broadly defined as therapy within the standard of care for a particular infection and should be consistent within a given institution. Participants will undergo the recommended therapy for specific infections for 42 days.
11995192|NCT00627393|Biological|Granulocyte transfusions|Participants will receive one granulocyte transfusion per day until one of the following occurs: recovery from neutropenia, life-threatening toxicity, resolution or improvement of infection, or Day 42 after treatment. Granulocyte content of each transfusion is targeted to be at least 4 x 10^10 per collection (or proportionately less for participants less than 30 kg in weight).
11995193|NCT00627393|Drug|G-CSF/dexamethasone|Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.
11995390|NCT00625976|Behavioral|Physiotherapy|Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)
11995194|NCT00627393|Device|Apheresis machine|Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants.
11995195|NCT00627380|Behavioral|Yoga lifestyle intervention|Sixteen weeks of 2-3 yoga sessions per week, 1.5 hrs per session administered by a certified yoga instructor. Sessions include breathing exercises and yoga postures/positions.
11995196|NCT00627380|Other|Standard of care|Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary.
11995197|NCT00627367|Drug|Hydromorphone|Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
11995198|NCT00627367|Drug|Nonprotocolized|An IV opioid the type and dose of which will be determined by the treating clinician
11995199|NCT00627354|Drug|etoposide|
11995200|NCT00627354|Drug|mitoxantrone hydrochloride|
11995201|NCT00627354|Drug|prednisone|
11995202|NCT00627354|Drug|vinorelbine tartrate|
11995203|NCT00627341|Behavioral|Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)|AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.
11995204|NCT00627341|Behavioral|Cognitive behavioral therapy (CBT)|CBT for anorexia nervosa sessions will focus on behaviorally normalizing eating patterns throughout the day and on cognitively addressing dysfunctional thinking that promotes disordered eating.
11995205|NCT00627315|Procedure|Gastric bypass|NOTE: Surgery will not be paid by the study
11995206|NCT00627315|Procedure|Gastric banding|NOTE: Surgery will not be paid by the study
11995207|NCT00627302|Drug|PEG-400|Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
11995208|NCT00627302|Drug|Systane|Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
11995209|NCT00627276|Dietary Supplement|omega-3 fatty acid|Oral, 3 times daily
11995210|NCT00627276|Other|placebo|Oral, 3 times daily
11995211|NCT00627263|Behavioral|Stress reduction treatment (SRT) program|The SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.
11995212|NCT00627250|Drug|Amantadine|Amantadine 100 mg every morning and 12 noon
11995213|NCT00627237|Behavioral|Immediate Start|Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
11995214|NCT00627237|Behavioral|Waitlist|Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
11995215|NCT00627211|Procedure|CO2 insufflation|From the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy.
11995216|NCT00627185|Behavioral|Internet-delivered continuing professional development|Interactive motivational website for dentists and hygienists with practice improvement resources, discussion forum, and educational cases on cessation counseling with email reminders.
11995217|NCT00627185|Other|No intervention arm|
11995218|NCT00627159|Other|High risk assessment|For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All participants predicted to be at high risk are referred for assessment to a High Risk clinic in the community via the family doctor.
11995219|NCT00627159|Other|Low to moderate risk|For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All low to -moderate risk participants are directed to self-refer to the Calgary Health Region Multicultural education classes.
11995220|NCT00627146|Drug|ChAgly CD3|6 days treatment 8mg/d intravenous
11995221|NCT00627146|Drug|Placebo|6 days
11995222|NCT00627133|Drug|levetiracetam|2 gram iv load, 500mg bid
11995223|NCT00627120|Drug|VGX-1027|Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
11995224|NCT00627107|Device|ReWalk - a motorized exoskeleton suit|The subject will wear the ReWalk suit and have training sessions for walking with the device.
11995225|NCT00627094|Device|Biatain|A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.
11995226|NCT00627094|Device|Biatain Ibu|Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
11995227|NCT00627081|Drug|remifentanil|dosage
11995228|NCT00627055|Drug|LPV/r|LPV/r dosing = 400mg/100mg orally q12h for 48 weeks
11995229|NCT00627055|Drug|LPV/r + TDF/FTC or TDF/3TC|TDF/FTC (Truvada) 1 pill orally q 24 hr or TDF 300mg orally q 24 hr/3TC 300mg orally q 24 hr (or 3TC 150mg orally q 12 hr) for 48 weeks
11995230|NCT00627042|Biological|Ramucirumab (IMC-1121B)|Participants will receive ramucirumab (IMC-1121B) at 8 milligrams per kilogram (mg/kg) administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
11995231|NCT00627029|Behavioral|Care Coordination|Depending on the demonstration site, may consist of nurse telephonic counseling and monitoring, nurse in-person or home visits, home telemonitoring equipment, patient educational materials, patient group educations classes, physician education and feedback.
11995232|NCT00627016|Drug|Dexlansoprazole|30 mg capsule, orally, once daily for 4 weeks
11995233|NCT00627016|Drug|Placebo|1 capsule, orally, once daily for 4 weeks
11995234|NCT00627003|Drug|Cabergoline|Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks
11995235|NCT00627003|Other|Placebo|Placebo oral tablets administered daily for 5 weeks
11995236|NCT00626990|Drug|temozolomide|Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
11995237|NCT00626990|Genetic|DNA methylation analysis|MGMT methylation status is used for stratification at randomization.
11995238|NCT00626990|Other|laboratory biomarker analysis|Prognostic factor analyses
11995239|NCT00626990|Procedure|adjuvant therapy|Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
11995240|NCT00626990|Procedure|quality-of-life assessment|Quality of Life analysis will also be used to assess neurological deterioration free progression
11995241|NCT00626990|Radiation|radiation therapy|Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
11995242|NCT00626977|Drug|ropivacaine|15 ml of ropivacaine 0.125% peridural once
11995243|NCT00626977|Drug|ropivacaine and clonidine|15 ml of ropivacaine 0.0625% plus 75 mcg clonidine
11995244|NCT00626964|Procedure|Bariatric Surgery|Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.
11995245|NCT00626964|Behavioral|Conservative Treatment:|Intensive Lifestyle Intervention Program
11995246|NCT00626951|Device|LMA Supreme|Extraglottic airway devices
11995247|NCT00626951|Device|LMA ProSeal|
11995248|NCT00626925|Drug|topiramate|up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
11995249|NCT00626925|Drug|placebo|placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
11995250|NCT00626912|Procedure|endovascular coil embolization|standard endovascular coil embolization with or without adjunct techniques
11995251|NCT00626886|Drug|Bupivacaine Collagen Sponge|collagen; Bupivacaine hydrocholoride
11995252|NCT00626886|Drug|placebo collagen sponge|collagen
11995253|NCT00626873|Drug|Definity|Definity - perflutren lipid microspheres, 1-10 microns in diameter, which is approved for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, to enhance the visualization of the ovarian vascular system.
11995254|NCT00626873|Other|medical chart review|
11995255|NCT00626860|Biological|DC/tumor fusion vaccine|SC vaccinations administered to each patient at 3-week intervals for 2-3 doses
11995256|NCT00626834|Drug|Vigabatrin|Dose 1 BID
11995257|NCT00626834|Drug|Vigabatrin|Dose 2 BID
11995258|NCT00626834|Drug|Vigabatrin|Dose 3 BID
11995259|NCT00626834|Drug|Matching placebo|Matching placebo BID
11995260|NCT00626821|Device|SenSura|Real life assessment of SenSura
11995261|NCT00626808|Drug|No Intervention|There were no interventions. No subjects were enrolled in this retrospective database study.
11995262|NCT00626795|Drug|TD1414 2% cream|BID 7 days
11995263|NCT00626795|Drug|TD1414 2% cream|TID 7 days
11995264|NCT00626795|Drug|Bactroban® (mupirocin) 2% cream|BID 7 days
11995265|NCT00626782|Drug|Ranibizumab|Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
11995266|NCT00626782|Drug|Mitomycin (MMC)|Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
11995267|NCT00626769|Dietary Supplement|aglycone genistein|2 capsules per day containing 27 mg of aglycone genistein, calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
11995268|NCT00626769|Dietary Supplement|placebo|2 capsules per day containing calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
11995269|NCT00626756|Device|LiDCO technology|non invasive monitoring of cardiac output
11995270|NCT00626743|Drug|SK3530 100mg, Placebo, Amlodipine|
11995271|NCT00626730|Procedure|adjuvant therapy|
11995272|NCT00626730|Radiation|radiation therapy|
11995273|NCT00626717|Procedure|Riboflavin/UVA crosslinking|Removal of epithelium. Riboflavin eye drops. UVA exposure.
11995274|NCT00626717|Procedure|Sham treatment|Fluorescein eye drops. Exposure with blue light
11995275|NCT00626704|Drug|AMG 655|AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
11995276|NCT00626704|Other|Placebo|Inactive dummy AMG 655 (to maintain blind)
11995277|NCT00626704|Drug|Doxorubicin|Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.
11995278|NCT00626691|Behavioral|Walnut consumption|Subjects will be randomized to receive either 0.75 oz (22.5 g) or 1.5 oz (45 g) of walnuts daily for the first 6 wk period, followed by a 6 wk washout period, and an additional 6 wk period during which they will receive the reverse dose of walnuts daily. Each serving of walnuts will be pre-weighed and pre-packaged.
11995279|NCT00626678|Drug|Azathioprine|It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
11995280|NCT00626678|Drug|Prednisone|Oral corticosteroid initiated at 2 mg/kg/day dosage. Dosage may be tapered primarily by 1/3 total dosage if no new blister, then 5 mg every three days to reach the daily dosage of 30 mg then tapered by 1.25 mg every week to reach daily dosage of 20 mg/day, then tapered by 1.25 mg every two weeks to reach daily dosage of 10 mg, then tapered by 1.25 mg monthly to reach daily dosage of 7.5 mg and continue this dosage for six months then tapered to 5 mg/day if no new lesions are observed as determined by clinical assessment of the investigator.
11995281|NCT00626678|Drug|Placebo|Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
11995282|NCT00626665|Drug|Tadalafil|Tablets Tadalafil, 20 mg, alternate days, 6 weeks
11995283|NCT00626652|Drug|K201 Injection|single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule
11995284|NCT00626639|Drug|Placebo|Administered by intravenous (IV) bolus injection
11995285|NCT00626639|Drug|palifermin|Administered by intravenous (IV) bolus injection
11996601|NCT00617994|Drug|Ruxolitinib|Ruxolitinib 1.5% cream BID for 28 days
11995286|NCT00626639|Radiation|Radiotherapy|Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation [one fraction per day])
11995287|NCT00626639|Drug|Cisplatin|100 mg/m^2 intravenously (IV) on days 1, 22 and 43.
11995288|NCT00626626|Drug|Clofar, Cyclophos, Alemtuzumab|Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion.
11995289|NCT00626626|Drug|Clofar, Cyclophos,Alemtuzumab(Ph II)|Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)
11995290|NCT00626613|Drug|Risperdal,reminyl|Risperdal:The dosage of treatment medication will begin with 0.5 ml/ per day (0.5mg), The maximum dose will be 2ml/ per day reminyl:8 mg/ per day
11995291|NCT00626600|Drug|Oxycodone Hydrochloride|
11995292|NCT00626587|Device|Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)|The TBNA apparatus (Olympus NA-2C-1) is inserted through the working channel, and is advanced until it reaches the target lesion which is localized by EBUS. Negative manual suction is applied with the 20 ml syringe. The specimens are then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion are obtained.
11995293|NCT00626574|Drug|Epoetin alfa|Intravenous administration of epoetin alfa (40,000 IU) immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.
11995294|NCT00626574|Drug|Saline|3ml of saline will be administered via an IV push immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.
11995295|NCT00626561|Drug|Bevacizumab|10 mg/kg IV twice weekly on days 1 and 15.
11995296|NCT00626561|Drug|Paclitaxel|60 mg/m^2 IV weekly on days 1, 8, 15, and 22.
11995297|NCT00626548|Drug|ZD4054|10 mg once daily oral dose
11995298|NCT00626548|Drug|Palcebo|Matching Plcebo oral tablet once daily
11995299|NCT00626535|Drug|Esomeprazole|20mg Oral Once Daily
11995300|NCT00626535|Drug|Matching placebo|Oral Once Daily
11995301|NCT00626522|Drug|Aclidinium bromide and formoterol|once daily
11995302|NCT00626522|Drug|Aclidinium bromide and formoterol placebo|once daily
11995303|NCT00626509|Drug|sunitinib malate|
11995304|NCT00626509|Procedure|adjuvant therapy|
11995305|NCT00626509|Procedure|neoadjuvant therapy|
11995306|NCT00626509|Procedure|therapeutic conventional surgery|
11995307|NCT00626483|Biological|RNA-loaded dendritic cell vaccine|Only one dose of DCs (2 x 10^7) is being assessed.
11995308|NCT00626483|Drug|basiliximab|Basiliximab 20 mg and 40 mg is being assessed depending on dose-cohort enrollment.
11995309|NCT00626470|Procedure|Addition of TSP to DHS|All patients operated with DHS. Of these two groups. One operated with TSP and one without.
11995310|NCT00626457|Behavioral|Behavioral weight-loss/lifestyle interventions|6-month intervention (28 weekly classes)
11995311|NCT00626444|Drug|Intravenous vitamin C|Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
11995312|NCT00626431|Drug|Leuprolide acetate - Formulation A|Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.
11995313|NCT00626431|Drug|Leuprolide acetate - Formulation B|Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.
11995314|NCT00626418|Drug|Aplindore|Tablets 0.05, 0.1, 0.2, 0.3, 0.5 and 0.7 mg QD for up to 6 nights
11995315|NCT00626418|Drug|Placebo|Placebo tablets
11995316|NCT00626405|Biological|bevacizumab|Given IV over 30-90 minutes
11995317|NCT00626405|Drug|carboplatin|Given IV over 30 minutes
11995318|NCT00626405|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV over 30 minutes
11995319|NCT00626405|Drug|temozolomide|Oral temozolomide on days 1-5
11995320|NCT00626392|Drug|niacin extended-release (NER)|Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
11995321|NCT00626392|Drug|aspirin (ASA)|325 mg tablets administered once daily
11995322|NCT00626392|Drug|aspirin placebo (ASA Pbo)|Tablets administered once daily
11995323|NCT00626366|Radiation|Sinus CT Scan|Subjects will undergo a Xoran miniCAT scan of their sinuses
11995324|NCT00626366|Drug|Omnipaque 240 Contrast Solution|Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
11995325|NCT00626366|Drug|Omnipaque 240 mg I/mL|Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
11995326|NCT00626353|Other|Home-based rehabilitation|Rehabilitation at home during hospital stay and after discharge
11995327|NCT00626353|Other|Standard care|Standard care during hospital stay and in the municipality after discharge
11995328|NCT00626340|Drug|MDD diagnosis and Estrogen treatment|Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause.
11995329|NCT00626340|Drug|MDD diagnosis and Fluoxetine treatment|Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.
11995330|NCT00626340|Drug|MDD diagnosis with both Estrogen and Fluoxetine treatment|Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
11995331|NCT00626340|Drug|No depression and estrogen treatment|Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.
11995391|NCT00625950|Procedure|ENDOMETRIAL BIOPSY|Two routine laparoscopies in period of three months with endometrial biopsy comparative study performed.
11995332|NCT00626327|Biological|MenACWY-CRM + MMRV|One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.
11995333|NCT00626327|Biological|MMRV|one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
11995334|NCT00626327|Biological|MenACWY-CRM|Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age
11995335|NCT00626314|Biological|myoblast|autologous myoblast
11995336|NCT00626314|Biological|sham|sham injection procedure
11995337|NCT00626301|Drug|LPV/r|LPV/r 230/57.5 mg/m2 orally q12h or the adjusted dose based on therapeutic drug monitoring of LPV/r prior to enrollment as maintenance monotherapy
11995338|NCT00626288|Drug|Mesalazine|Mesalazine 800mg t.i.d. 12 weeks
11995339|NCT00626288|Drug|Placebo|Placebo cpr, t.i.d. 12 weeks
11995340|NCT00626275|Drug|ADL5859|
11995341|NCT00626275|Drug|Naproxen|
11995342|NCT00626275|Drug|Placebo|
11995343|NCT00626275|Drug|ADL5859|
11995344|NCT00626275|Drug|Placebo|
11995345|NCT00626262|Drug|Esomeprazole|Oral and Intravenous
11995346|NCT00626249|Drug|Technosphere Inhalation Powder|Technosphere Inhalation Powder
11995347|NCT00626236|Drug|SPN-810|capsule taken three times a day
11995348|NCT00626236|Drug|SPN-810|capsule taken TID
11995349|NCT00626236|Drug|SPN-810|capsule taken TID
11995350|NCT00626236|Drug|SPN-810|capsule taken TID
11995351|NCT00626223|Drug|5-MTHF (5-methyltetrahydrofolate)|50 mg intravenous at the end of each hemodialysis session
11995352|NCT00626223|Drug|folic acid|5 mg per day of oral folic acid
11995353|NCT00626210|Drug|modafinil|100-400 mg daily for 4 weeks
11995354|NCT00626197|Drug|Corticosteroids|Intravenous and oral repeating dose
11995355|NCT00626197|Drug|Cyclophosphamide|Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.
11995356|NCT00626197|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.
11995357|NCT00626197|Drug|Ocrelizumab|Ocrelizumab was administed at a dose and as per schedule in arm description
11995358|NCT00626197|Drug|Placebo|Placebo was administered as per schedule in arm description
11995359|NCT00626197|Drug|Azathioprine|Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.
11995360|NCT00626184|Drug|4 dose levels of ALV003|4 dose levels of ALV003 vs placebo
11995361|NCT00626171|Procedure|Allergen Challenge|Allergen challenge
11995362|NCT00626158|Drug|gemcitabine|1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days)
11995363|NCT00626158|Drug|capecitabine|starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)
11995364|NCT00626145|Procedure|saline infusion|Patients receive intracoronary injections of saline 7 days after PCI.
11995365|NCT00626145|Procedure|autologous bone marrow mononuclear cells infusion|Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
11995366|NCT00626132|Dietary Supplement|Eucommia|two capsules three times a day orally for 2 weeks
11995367|NCT00626106|Drug|AMG 479 or placebo administered with either exemestane or fulvestrant|Arm 2 - placebo with exemestane or fulvestrant
11995368|NCT00626106|Drug|AMG 479 or placebo administered with either exemestane or fulvestrant|Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant
11995369|NCT00626106|Drug|AMG 479 or placebo administered with either exemestane or fulvestrant|Arm 1 - AMG 479 administered with exemestane or fulvestrant
11995370|NCT00626093|Device|Cardiac Resynchronization Therapy - Defibrillator (CRT-D)|"Patients in the study who receive Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for Cardiac Resynchronization Therapy (CRT).
~Patient undergoes Defibrillation threshold (DFT) testing at implant and at 6 months. Defibrillation threshold (DFT) testing will include 3 ventricular fibrillation (VF) inductions."
11995371|NCT00626080|Drug|Insulin detemir|100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID
11995372|NCT00626080|Drug|Insulin NPH|100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID
11995373|NCT00626067|Device|Fully functional monitoring device|Pt received fully functional monitoring dispenser for use with their Travatan eye drops
11995374|NCT00626067|Device|Partially functional monitoring device|Patient received a particually functional Travatan Compliance Monitoring Dispenser
11995375|NCT00626067|Device|Non-functional monitoring device|Patient received a non functioning Travatan Compliance Monitoring Dispenser
11995376|NCT00626054|Drug|PEG solution in a single dose of 3 liters|Group 1 will receive the precolonoscopy PEG solution in a single dose of 3 liters in the evening preceding the test.
11995377|NCT00626054|Drug|PEG solution|PEG solution: half the dose (1.5 liters) of the identical solution in the evening preceding the test and the other half (1.5 liters) on the morning of the test
11995378|NCT00626041|Other|participant referral to primary care network physician|blood pressure, cholesterol and hemoglobin A1c screening and management
11995379|NCT00626028|Drug|Nitric Oxide for inhalation|Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
11995380|NCT00626028|Drug|Oxygen|100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
11995381|NCT00626028|Drug|Nitric Oxide plus Oxygen|Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
11995382|NCT00626015|Biological|PEP-3-KLH conjugate vaccine|Given intradermally
11995383|NCT00626015|Biological|daclizumab|Given IV
11995384|NCT00626015|Drug|temozolomide|Given by mouth.
11995385|NCT00626015|Other|placebo|Given IV
11995386|NCT00626015|Biological|PEP-3-KLH|Basiliximab 20 mg IV over 30 minutes with PEP-3-KLH vaccine # 1 only.
11995387|NCT00626002|Drug|ABT-874|100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks
11995388|NCT00625989|Drug|Aeroallergen|
11995389|NCT00625976|Behavioral|Graded exposure in vivo|Graded exposure in vivo according to the protocol of de Jong et al. (2005)
11995396|NCT00625924|Behavioral|questionnaires|Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States - Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'
11995397|NCT00625924|Behavioral|questionnaires|Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States -Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'
11995398|NCT00625924|Behavioral|questionnaires|Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States -Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'
11995399|NCT00625911|Drug|morphine|intravenous patient controlled analgesia, standard protocol
11995400|NCT00625911|Drug|morphine ketamine|low dose ketamine added to 2/3 standard dose of morphine
11995401|NCT00625898|Drug|Docetaxel|"75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B
~100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B"
11995402|NCT00625898|Drug|Trastuzumab|"First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B
~First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B"
11995403|NCT00625898|Drug|Carboplatin|6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6
11995404|NCT00625898|Drug|Bevacizumab|"15 mg/kg IV on day 1 every 3 weeks for cycles 1-6. Following completion of chemotherapy cycles: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 1B
~15 mg/kg IV on day 1 every 3 weeks for cycles 1-3. 21 days after the last dose of FEC: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 2B"
11995405|NCT00625898|Drug|5-Fluorouracil|600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
11995406|NCT00625898|Drug|Epirubicin|90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
11995407|NCT00625898|Drug|Cyclophosphamide|600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
11995408|NCT00625872|Drug|Somatropin|Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
11995409|NCT00625872|Drug|Somatropin|Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
11995410|NCT00625859|Drug|GSK189075|GSK189075 will be available as film-coated tablets with a dose of 250 milligrams.
11995411|NCT00625859|Drug|Bupropion|Bupropion will be available as sustained release film-coated tablets with a dose of 150 milligrams administered orally.
11995412|NCT00625859|Drug|Placebo|Placebo tablets will be given to subjects.
11995413|NCT00625846|Other|Laboratory Biomarker Analysis|Correlative studies
11995414|NCT00625846|Drug|Pazopanib Hydrochloride|Given PO
11995415|NCT00625833|Drug|Placebo|Oral tablet once a day dosing for 10 weeks.
11995416|NCT00625833|Drug|[S,S]-Reboxetine|Oral tablet once a day dosing for 10 weeks.
11995417|NCT00625820|Drug|6R BH4|400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks in all arms
11995418|NCT00625820|Dietary Supplement|Vitamin C|500 mg Vitamin C oral BID for another 6 weeks
11995419|NCT00625807|Behavioral|RR|A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
11995420|NCT00625807|Behavioral|MBSR|A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
11995421|NCT00625794|Drug|Nicotine nasal spray|8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).
11995422|NCT00625794|Behavioral|Smoking cessation counseling|8 weeks or counseling
11995423|NCT00625781|Drug|Insulin aspart and Insulin human (isophane)|Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol.
11995424|NCT00625768|Drug|AS1409|Study drug
11995425|NCT00625755|Biological|Electrofusion DC vaccine|To assess the safety and efficacy of vaccinations
11995426|NCT00625742|Behavioral|Graded Resistance Training|Resistance training sessions twice weekly using Thera-bands.
11995427|NCT00625742|Behavioral|Aerobic Exercise|Walking or running for 3-4 minutes at 70-80% of your maximum predicted heart rate.
11995428|NCT00625742|Drug|Melatonin|20 mg by mouth (PO) Daily
11995429|NCT00625742|Dietary Supplement|Juven|90 calories of Juven, twice a day.
11995430|NCT00625742|Drug|Atenolol|Atenolol will only be taken if there's evidence of increased sympathetic activity (resting heart rate >110 beats/min) or resting energy expenditure (REE) > 110% of predicted.
11995431|NCT00625742|Drug|Ibuprofen|Ibuprofen 1200mg/day in three divided doses.
11995432|NCT00625729|Biological|aldesleukin|Day 0-14, 10 million international units, 3 times per week for 6 doses
11995433|NCT00625729|Biological|allogeneic natural killer cells|Day 0 infusion of cells (1.5-8 x 10^7 cells/kg).
11995434|NCT00625729|Biological|rituximab|Administered Day -8, day -1, day +6 and day +13, intravenously (IV) 357 mg/m^2
11995435|NCT00625729|Drug|cyclophosphamide|60 mg/kg intravenous (IV) on Day -5.
11995436|NCT00625729|Drug|fludarabine phosphate|Day -6 through day -2, 25 mg/m^2 intravenous (IV)
11995473|NCT00625495|Drug|Esomeprazole|40mg Intravenous infusion over 3 minutes
11995474|NCT00625495|Drug|Esomeprazole|40mg Oral
11995475|NCT00625482|Biological|OPV|
11995476|NCT00625482|Biological|OPV plus BCG|
11995437|NCT00625703|Drug|Linezolid|"Pharmacokinetics
~daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid."
11995438|NCT00625690|Other|questionnaire administration|Subjects will be asked to complete an additional detailed questionnaire regarding personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members.
11995439|NCT00625690|Procedure|computed tomography|The baseline and repeat screening CT scans will be performed with a multi-slice helical CT scanner (8 or more rows), at a low-dose setting (120kVp, 40-80mA, slice thickness of 1.25 mm or less). In a single breath-hold, contiguous slices from the thoracic inlet to the adrenal glands will be obtained. Contrast material will not be used. Multi-slice scanners will be used because they provide higher-resolution images. Diagnostic studies, including HRCT will be performed with a multi-slice helical CT at diagnostic settings (120kVp, 140-300mA, slice thickness of 1.25 or less) with the nodule retrospectively reconstructed at a 15cm field of view.
11995440|NCT00625690|Procedure|evaluation of cancer risk factors|When the CT scan at baseline does not lead to the diagnosis of malignancy, repeat screening will be scheduled 12 months later. If the initial scan led to further evaluation, the repeat scan will be performed 12 months after the most recent scan. The subjects will be allowed to add relevant health information to their record in the web-based database as it develops. Similarly, when in the first repeat screening malignancy is not diagnosed; the second repeat screening will be scheduled 12 months later for a total period of 5 years.
11995441|NCT00625690|Procedure|study of high risk factors|When the CT scan at baseline does not lead to the diagnosis of malignancy, repeat screening will be scheduled 12 months later. If the initial scan led to further evaluation, the repeat scan will be performed 12 months after the most recent scan. The subjects will be allowed to add relevant health information to their record in the web-based database as it develops. Similarly, when in the first repeat screening malignancy is not diagnosed; the second repeat screening will be scheduled 12 months later for a total period of 5 years.
11995442|NCT00625677|Biological|NeisVacC (Meningococcal C conjugate vaccine)|Dosage
11995443|NCT00625677|Biological|Menjugate (Meningococcal C conjugate vaccine)|Dosage
11995444|NCT00625664|Drug|larotaxel (XRP9881)|administered on day 1 as a 1-hour infusion
11995445|NCT00625664|Drug|gemcitabine|administered on day 1, 8 and 15 as a 30-minute infusion
11995446|NCT00625664|Drug|cisplatin|1 hour infusion administered on day 1, 30 minutes after the other treatment
11995447|NCT00625651|Drug|Placebo|Inactive dummy AMG 655 (to maintain blind)
11995448|NCT00625651|Drug|AMG 655|AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
11995449|NCT00625651|Drug|Modified FOLFOX6|Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
11995450|NCT00625651|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
11995451|NCT00625638|Behavioral|Interactive Voice Response System|Phone calls made once daily, each taking about 3-5 minutes to complete.
11995452|NCT00625638|Other|Standard Care|Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.
11995453|NCT00625625|Drug|isosulfan blue|
11995454|NCT00625625|Genetic|polymerase chain reaction|
11995455|NCT00625625|Other|diagnostic laboratory biomarker analysis|
11995456|NCT00625625|Other|immunohistochemistry staining method|
11995457|NCT00625625|Procedure|diagnostic lymphadenectomy|
11995458|NCT00625625|Procedure|therapeutic conventional surgery|
11995459|NCT00625625|Procedure|therapeutic lymphadenectomy|
11995460|NCT00625612|Drug|Denufosol Tetrasodium (INS37217) Inhalation Solution|Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
11995461|NCT00625612|Drug|Placebo|Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
11995462|NCT00625599|Other|Osteoporosis Prevention Information|Primary investigator designed osteoporosis prevention information.
11995463|NCT00625586|Biological|RAV12 plus gemcitabine|"Initial dose of gemcitabine plus RAV12 at 0.375 mg/kg qw escalated to 0.75 mg/kg qw.
~During the efficacy segment, 63 pts were to be treated with gemcitabine 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days plus RAV12 at Maximum Tolerated Dose (MTD) iv days 1; 4 or 5; 8, 11 or 12; and 15, 18 or 19 of each 28-day cycle until progression."
11995464|NCT00625573|Drug|Abraxane|100mg/m2 every week X's 3
11995465|NCT00625560|Drug|Entecavir|entecavir 1.0 mg QD
11995466|NCT00625560|Drug|Lamivudine|lamivudine 100 mg QD
11995467|NCT00625547|Drug|cabergoline|Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events
11995468|NCT00625547|Drug|levodopa|Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events
11995469|NCT00625534|Procedure|Laparoscopic totally extraperitoneal inguinal hernia repair|3 trocars procedure. Blunt camera dissection without use of balloon dissector. Anatomical, preformed, polyester mesh passed around spermatic cord structures. No fixation of mesh.
11995470|NCT00625534|Procedure|Open tension free inguinal hernia mesh repair|Classical Lichtenstein repair. Polyester flat 14x8cm mesh
11995471|NCT00625521|Drug|ASF 1096 0.5 % cream applied twice daily|
11995472|NCT00625521|Drug|Cream vehicle for ASF 1096 cream applied twice daily|
11995479|NCT00625469|Drug|bosentan|62.5mg orally bid for first month, followed by 125mg bid thereafter
11995480|NCT00625456|Drug|Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)|Intravenous Dosage from 1 x 10^5 pfu/kg to 3 x 10^7 pfu/kg Intravenous infusion is administered once over a 60 minute period
11995481|NCT00625443|Drug|Blinded (placebo)|"Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)
~Duration - 6 months"
11995482|NCT00625443|Drug|Open Label (Avatrombopag tablets)|"Dose 10 mg
~Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)
~Duration - 6 months"
11995483|NCT00625443|Drug|Blinded (Avatrombopoag tablets)|"Dose: 2.5, 5, 10, or 20 mg
~Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)
~Duration - 6 months"
11995484|NCT00625430|Biological|Gene Directed Enzyme Prodrug Therapy, FP253/Fludarabine|"Subjects within a treatment group will be administered a single transrectal intraprostatic injection of FP253.
~Group A: 1 x 10Exp9 virus particles (VP); Group B: 3.2 x 10Exp9 VP; Group C: 1 x 10Exp10 VP; Group D: 3.2 x 10Exp10 VP; Group E: 1 x 10Exp11 VP; Group F: 3.2 x 10Exp 11 VP.
~If there are no dose-limiting toxicities, three additional patients may be treated at the highest dose.
~Twenty four hours following administration of the FP253, subjects will receive a first dose of fludarabine phosphate (20mg/m2 administered as an intravenous bolus). The first dose of fludarabine phosphate will be followed by 4 further doses at 24 hour intervals on treatment Days 3 to 6."
11995485|NCT00625417|Procedure|breast biopsy|
11995486|NCT00625417|Procedure|histopathologic examination|
11995487|NCT00625417|Procedure|light-scattering spectroscopy|
11995488|NCT00625417|Procedure|therapeutic conventional surgery|
11995489|NCT00625404|Drug|Truvada|Daily single oral tablet of Truvada - a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
11995490|NCT00625404|Other|Placebo|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
11995491|NCT00625391|Drug|Placebo|500 mg medicinal starch pills daily
11995492|NCT00625391|Drug|Green Tea Polyphenols (GTP)|500 mg green tea polyphenols daily
11995493|NCT00625391|Drug|Placebo+Tai Chi (TC)|500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks
11995494|NCT00625391|Drug|GTP+TC|500 mg GTP daily plus TC exercise (3x/week) for 24 weeks
11995495|NCT00625378|Drug|Sorafenib (Nexavar, BAY43-9006)|
11995496|NCT00625365|Drug|DEFINITY®|DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert
11995497|NCT00625352|Drug|Gemcitabine, UFT|Gemcitabine 1,250mg/m2 IV on D1 and D8 of every 3 weeks combined with UFT 400mg daily PO for 14 days every 3 weeks. Gemcitabine will be administered to patients a maximum of 4 cycles, and then discontinued. UFT will be continued until progression.
11995498|NCT00625339|Drug|Entecavir|entecavir 0.5 mg QD
11995499|NCT00625339|Drug|Lamivudine|lamivudine 100 mg QD
11995500|NCT00625326|Drug|COL-121|75 µg/g COL-121 Ointment
11995501|NCT00625326|Drug|50 µg/g Calcipotriene Ointment|50 µg/g Calcipotriene Ointment
11995502|NCT00625326|Drug|Placebo|Placebo
11995503|NCT00625326|Drug|COL-121|150 µg/g COL-121 Ointment
11995504|NCT00625326|Drug|COL-121|300 µg/g COL-121 Ointment
11995505|NCT00625313|Device|HMY Model YA-60BB IOL|Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
11995506|NCT00625300|Device|repetitive transcranial stimulation (r-TMS)|Each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (active) over the motor cortex and the prefrontal cortex.
11995507|NCT00625300|Device|Repetitive transcranial stimulation|Sham treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of sham stimulation trains over the motor cortex and the prefrontal cortex.
11995508|NCT00625274|Drug|Esomeprazole|40mg Oral
11995509|NCT00625274|Drug|Lansoprazole|30mg Oral
11995510|NCT00625274|Drug|Pantoprazole|40mg Oral
11995511|NCT00625261|Other|Heidelberg Parent-based Language Intervention HPLI|The HPLI is a group program for parents of young children with language delay. This 12-14week program includes seven two-our sessions and one three-our session six months later. It is designed for 5 to 10 people and based of an interactive model of language intervention, wich presumes that optimized parental input will provide better language-learning opportunities.
11995512|NCT00625248|Drug|Antithrombotics|With or without or discontinuted use of Antithrombotics
11995513|NCT00625235|Dietary Supplement|VLED followed by a high protein or high carbohydrate diet|
11995514|NCT00625222|Procedure|transcranial direct current stimulation|1mA, 15 Minutes, constant direct current
11995515|NCT00625209|Drug|placebos|placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of fludrocortisone given through the nasogastric tube once a day for seven days plus placebo of activated protein C given as a continuous infusion for 96 hours
11995516|NCT00625209|Drug|hydrocortisone and fludrocortisone and placebo|hydrocortisone will be given as 50mg iv bolus every 6 hours for seven days and a tablet of 50µg of fludrocortisone will be given once a day via the nasogastric tube for seven days and a placebo of activated protein C will be given as a continuous infusion for 96 hours
11995517|NCT00625209|Drug|recombinant human activated protein C and placebos|activated protein C will be given as a continuous infusion at a dose of 24 µg/kg/h four 96 hours and hydrocortisone placebo as an iv bolus every 6 hours and fludrocortisone placebo once a day through the gastric tube will be given for seven days
11995518|NCT00625209|Drug|recombinant human activated protein C and hydrocortisone and fludrocortisone|96 hours continuous infusion of 24µg/kg/h of activated protein C plus seven day treatment with 50mg iv bolus of hydrocortisone every 6 hours and 50µg of fludrocortisone via the nasogastric tube once a day
11995519|NCT00625196|Drug|Fluticasone foroate/ vilanterol|Fluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler.
11995520|NCT00625196|Drug|Fluticasone foroate|Fluticasone foroate 800 micrograms will be available as dry powder inhaler.
11995521|NCT00625196|Drug|Vilanterol|Vilanterol will be available as dry powder inhaler.
11995522|NCT00625196|Drug|Placebo|Placebo will be supplied as dry powder inhaler.
11995523|NCT00625183|Dietary Supplement|selenomethionine|
11995524|NCT00625183|Drug|capecitabine|
11995525|NCT00625183|Drug|oxaliplatin|
11995526|NCT00625183|Other|laboratory biomarker analysis|
11995527|NCT00625183|Other|pharmacological study|
11995528|NCT00625183|Procedure|adjuvant therapy|
11995529|NCT00625183|Procedure|neoadjuvant therapy|
11995530|NCT00625183|Procedure|therapeutic conventional surgery|
11995531|NCT00625183|Radiation|radiation therapy|
11995532|NCT00625170|Drug|olanzapine|olanzapine 10 mg/day for 8 days
11995533|NCT00625170|Drug|Haloperidol|haloperidol 3 mg/day for 8 days
11995534|NCT00625157|Drug|ASF 1096 0.5 % cream|
11995535|NCT00625157|Drug|ASF 1096 placebo cream|
11995536|NCT00625131|Drug|Nicotine|Delivered through transdermal nicotine patch
11995537|NCT00625131|Behavioral|Cognitive Behavioral Therapy for Smoking Cessation|Manualized protocol for CBT in smoking cessation
11995538|NCT00625131|Drug|Bupropion Sustained Release (SR)|Antidepressant
11995539|NCT00625131|Drug|Placebo patch|Pre-treatment placebo transdermal patch
11995540|NCT00625105|Behavioral|Biofeedback|
11995541|NCT00625092|Drug|fluorouracil|Post-operative day 1 and day 2, 600mg/m^2 intraperitoneal (IP) held for 23 hours
11995542|NCT00625092|Drug|leucovorin calcium|Day 0 200 mg/m^2 intraperitoneal held for 2 hours
11995543|NCT00625092|Drug|oxaliplatin|Day 0 hyperthermic intraperitoneal oxaliplatin held for 30 minutes - assigned dose level: Levels 1 through 7 - 300 to 600 mg/m^2
11995544|NCT00625092|Procedure|cytoreductive surgery|Day 0 Cytoreductive surgery is a systematic attempt to remove all or nearly all peritoneal nodules.
11995545|NCT00625079|Drug|sildenafil|the dose of sildenafil will be 20mg three times per day (orally)
11995546|NCT00625066|Other|biologic sample preservation procedure|
11995547|NCT00625066|Other|cytology specimen collection procedure|
11995548|NCT00625066|Other|medical chart review|
11995549|NCT00625066|Other|questionnaire administration|
11995550|NCT00625066|Other|survey administration|
11995551|NCT00625066|Procedure|biopsy|
11995552|NCT00625066|Procedure|evaluation of cancer risk factors|
11995553|NCT00625066|Procedure|screening colonoscopy|
11995554|NCT00625053|Procedure|Laparoscopic repair|Complete adhesiolysis between viscera and abdominal wall, complete dissection of round ligament and subumbilical fatty tissue to expose the posterior fascia at least 5 cm further than the cranial and caudal limits of the fascial defect or the original incision. Overlap of minimum 5 cm is calculated and mesh inserted in the abdominal cavity through 12mm optical trocar. Fixation of a antiadhesive composite mesh with helicoidal pins with maximum 15mm interval, double crown technique. No pressure decrease maneuver is done during mesh fixation or at another time during the operation. No transparietal suture fixation. No fascial closure.
11995555|NCT00625053|Procedure|Open midline incisional hernia repair|"Underlay retromuscular repair: Medial border of the anterior fascia opened, posterior aspect of rectus muscle dissected to reach lateral border of rectus sheet, bilaterally. Peritoneum and posterior rectus fascia closed with absorbable running suture. Polyester or light-weight polypropylene mesh is cut to fit the reconstructed area, to have 3cm overlap on caudal and cranial defect limits. Mesh is fixed by absorbable sutures. Anterior fascia is closed with absorbable running suture. Components separation upon need.
~Intraperitoneal onlay repair: Mesh is inserted intraperitoneally and fixed by a complete running suture (optional fixation with helicoidal pins or stapler). Fascial defect is closed with interrupted or running absorbable suture. Components separation upon need."
11995556|NCT00625040|Other|Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate|"OGTT: The test is performed with 50 g of glucose deluded in 300 ml water
~Isoglycemic iv. clamp: Iv. glucose infusion mimicking the glucose response curves from the OGTT
~Liquid Meal test: The test is performed with 100g of formula milk deluded in 300 ml. water
~Gastric Emptying Rate: Paracetamol absorption test."
11995557|NCT00625027|Other|Survey and Chart Review|After obtaining consent the survey will be completed. After a staff physician has assessed the patient, the chart will be consulted to retrieve the triage notes, diagnosis, treatment, and discharge recommendations. The physician will be asked to comment on the 'urgency' of the complaint and whether the patient would have been treated equally well at a walk-in clinic.
11995558|NCT00625014|Drug|Haloperidol|Haloperidol 3 mg/day for 8 days
11995559|NCT00624988|Procedure|Vibration Therapy|Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.
11995560|NCT00624975|Biological|Peru-15 Vaccine|up to 1 x 10^9 CFU of Peru-15 given in 5ml single dose vials with 20 ml buffer solution, given once
11995561|NCT00624975|Biological|Placebo|25 mL of buffer solution (2.5 g sodium bicarbonate and 1.65 g ascorbic acid per 100mL potable water)
11995562|NCT00624962|Dietary Supplement|nutritional intervention|Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy)
11995563|NCT00624962|Dietary Supplement|therapeutic nutritional supplementation|enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
11995564|NCT00624936|Drug|Vidaza|Vidaza 75mg/m2 IV over 30min daily on days 1-7. This dose is the same for all dose levels.
11995565|NCT00624936|Drug|Velcade|Dose level 1 Velcade 0.7mg/m2 IVP on days 2 and 5 Dose level 2 Velcade 0.7mg/m2 IVP on days 2, 5, 9, 12 Dose level 3 Velcade 1.0 mg/m2 IVP on days 2, 5, 9, 12 Dose level 4 Velcade 1.3 mg/m2 IVP on days 2, 5, 9, 12
11995566|NCT00624923|Drug|Salsalate|Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months
11995567|NCT00624923|Drug|Placebo|Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months
11995568|NCT00624910|Drug|Bupivacaine Collagen Sponge (CollaRx®)|The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
11995679|NCT00624286|Drug|Indacaterol 150 μg|Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
11995569|NCT00624910|Drug|placebo|The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
11995570|NCT00624871|Drug|Ascorbic acid (vitamin C)|IV, 100 mg/kg/day, every day, for 3 days
11995571|NCT00624871|Drug|Ibuprofen|PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life
11995572|NCT00624871|Drug|Placebo|
11995573|NCT00624858|Drug|naltrexone SR 32 mg/ bupropion SR 360 mg daily|"All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.
~During the study, subjects will receive ancillary therapy including advice on diet and exercise"
11995574|NCT00624845|Drug|OMS103HP|Maximum 6 bags of OMS103HP irrigation solution
11995575|NCT00624845|Drug|Vehicle|Maximum of 6 bags of vehicle irrigation solution
11995576|NCT00624832|Drug|Xolair|Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
11995577|NCT00624832|Drug|Placebo|Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.
11995578|NCT00624819|Biological|GSK1024805A|No vaccination in this trial
11995579|NCT00624819|Biological|Prevenar|No vaccination in this trial
11995580|NCT00624819|Biological|Infanrix hexa|No vaccination in this trial
11995581|NCT00624819|Biological|Havrix|No vaccination in this trial
11995582|NCT00624819|Biological|Varilrix|No vaccination in this trial
11995583|NCT00624806|Behavioral|Daily telephone calls|Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
11995584|NCT00624806|Behavioral|Weekly telephone calls|Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
11995585|NCT00624793|Other|Acupuncture|Standard Acup point protocol for treating nausea
11995586|NCT00624793|Other|Individualized Acup based on TCM diagnosis|Acup
11995587|NCT00624793|Other|Sham Acup|Sham Acup - Non-Active
11995588|NCT00624780|Drug|Pregabalin|Pregabalin 150-300 mg given twice a day
11995589|NCT00624780|Drug|Lorazepam|Lorazepam 3-4 mg given twice a day
11995590|NCT00624780|Drug|Pregabalin|Pregabalin 450-600 mg given twice a day
11995591|NCT00624780|Drug|Placebo|Placebo
11995592|NCT00624767|Drug|Insulin (recombinant human insulin)|Insulin Nasal Spray at doses up to 200 IU.
11995593|NCT00624767|Drug|NovoLog|NovoLog at doses up to 30 IU
11995594|NCT00624754|Drug|Formoterol/Budesonide|Budesonide/Formoterol 400/12: 800 µg b.i.d for 1 month
11995595|NCT00624754|Drug|lactose|Lactose 2 puffs b.i.d for 1 month
11995596|NCT00624741|Drug|Pergolide|Pergolide tablets should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.
11995597|NCT00624728|Radiation|18F Fluorothymidine PET CT|"18 FLT will be provided by the Laboratoire des Radiopharmaceutiques- Université Bordeaux2, Hôpital Xavier Arnozan and prepared according to the method described by Grierson and Shields ( Grierson J, Shields A. Nucl Med Biol 27 :143-156 ; 2000).
~Specific activity of 18FLT will be more than 37 GBq/µmol (>1Ci/µmol) corrected for decay at the end of bombardment of cyclotron target. Before tracer injection to patients, each dosis will be tested for pH and for radiochemical purity (> 95%) via HPLC technique and thin layer chromatography.
~18FLT dosis will be injected intravenously to the patients (10 mL of salted isotonic solution with less than 10 % (v/v) of ethanol (USP). Administrated activity will be calculated estimating total body surface of patient (2,6 MBq/kg ou 0,07 mCi/kg) with maximal activity of 185 MBq.
~PET acquisition will be realized as follows : Dynamic acquisition in 3D mode for 35 min, Iterative reconstruction (OSEM) with and without attenuation correction."
11995598|NCT00624715|Drug|THC|"High dose: 0.036 mg/kg (2.5 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking a full joint
~Low dose: 0.018 mg/kg (1.25 mg in a 70kg individual) IV (in the vein) dissolved in ethanol.Equivalent to smoking ½ of a joint
~Very low dose: 0.0036 mg/kg (0.25 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking 1/10 of a joint"
11995599|NCT00624715|Drug|Placebo|Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).
11995600|NCT00624702|Drug|Indacaterol maleate|Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
11995601|NCT00624702|Drug|Indacaterol maleate|Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
11995602|NCT00624702|Drug|Indacaterol maleate|Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
11995603|NCT00624702|Drug|Placebo|
11995604|NCT00624689|Dietary Supplement|Modified formula (MFGM-enriched formula with reduced energy and protein content)|MFGM-enriched formula with reduced energy and protein content
11995605|NCT00624676|Drug|Lipo Hydroxy Acid|Twice a day
11995606|NCT00624676|Drug|5% benzoyl peroxide gel|Once a day
11995607|NCT00624663|Drug|Rivastigmine|Administration 1 (A): 1 x 1.5 mg Exelon® Capsule (Novartis) + 1 x Placebo Capsule Administration 2 (B): 2 x 1.5 mg Exelon® Capsules (Novartis) Administration 3 (C): 2 x Placebo Capsules
11995608|NCT00624650|Drug|Diuresis (furosemide) part I|"Goal: Overall I/O net negative 50ml/hour
~Initiation:
~Continuous IV furosemide at 3mg/hour or last known protocol specified dose
~Titrate up or down by 3mg/hour increments every hour as needed to establish diuresis goal
~Do not exceed 30mg/hour
~Furosemide Bolus:
~If unable to establish adequate diuresis at maximum dose may attempt furosemide bolusing as follows
~By intravenous bolus give 30, then 60, then 80, and 120 mg - one bolus dose every hour until urine output results in 1 ml/kg PBW/hr net negative fluid balance per hour
~Bolusing trials may be done at will but total furosemide dose may not exceed 800mg/24hour period"
11995609|NCT00624650|Other|Fluid Bolus (crystalloid or albumin)|15 ml/kg PBW crystalloid (round to nearest 250 ml) or 25 grams albumin as rapidly as possible. Used for patients with a measured CVP<8 or measured PaOP <12mmHg in addition to concurrent urine output of <0.5 ml/kg/hr
11995682|NCT00624260|Other|semi-annual systematic PET-TDM|semi-annual systematic PET-TDM
11995610|NCT00624650|Other|Fluid Bolus (crystalloid or albumin)|"10 ml/kg PBW crystalloid (round to nearest 70ml) or 25 grams albumin as rapidly as possible.
~Perform thermodilution immediately before and after and 60 minutes after each bolus. If EVLW increases > 2ml/kg PBW within 60 minutes after a bolus do not give any further boluses until next regularly scheduled measurement. This therapy is available for patients with a map < 60 or who are on vasopressors that also have a measured GEDI less than goal"
11995611|NCT00624650|Drug|Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)|"(may use any alone or in combination)
~Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
~Vasopressin - 0.04 international units/hour
~Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
~Epinephrine - 1 mcg/min - may increase for effect not to exceed 20mcg/min.
~Weaning: When MAP ≥ 60 mm/Hg on stable dose of vasopressor begin reduction of vasopressor by greater than or equal to 25% stabilizing dose at intervals ≤ 4 hours to maintain MAP ≥ 60 mm/Hg."
11995612|NCT00624650|Drug|Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)|"(may use alone or in combination)
~Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
~Vasopressin - 0.04 international units/hour
~Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
~Epinephrine - 1 mcg/min - may increase for effect not to exceed 20mcg/min.
~Weaning: When MAP ≥ 60 mm/Hg on stable dose of vasopressor begin reduction of vasopressor by greater than or equal to 25% stabilizing dose at intervals ≤ 4 hours to maintain MAP ≥ 60 mm/Hg.
~In the experimental arm vasopressors are a treatment option in patients with a Mean Arterial Pressure of < 60"
11995613|NCT00624650|Drug|Dobutamine|"Begin at 5mcg/kg/min and increase by 3 mcg/kg/min increments at 15 minute intervals until C.I. ≥ 2.5 or maximum dose of 20mcg/kg/min has been reached.
~Begin weaning 4 hours after low CI is reversed. Wean by ≥ 25% of the stabilizing dose at intervals of ≤ 4 hours to maintain hemodynamic algorithm goals.
~If patient is on dobutamine as a result of an earlier cell assignment, dobutamine should be ignored for the purpose of subsequent assignment, but should be continued to be weaned per protocol.
~Used in patients with a measured cardiac index < 2.5"
11995614|NCT00624650|Drug|Dobutamine|"Begin at 5mcg/kg/min and increase by 3 mcg/kg/min increments at 15 minute intervals until C.I. ≥ 2.5 or maximum dose of 20mcg/kg/min has been reached.
~Begin weaning 4 hours after low CI is reversed. Wean by ≥ 25% of the stabilizing dose at intervals of ≤ 4 hours to maintain hemodynamic algorithm goals.
~If patient is on dobutamine as a result of an earlier cell assignment, dobutamine should be ignored for the purpose of subsequent assignment, but should be continued to be weaned per protocol."
11995615|NCT00624650|Other|Concentrate all drips and nutrition|"Concentrate all drips and nutrition in order to minimize fluid volume as much as possible. Intravenous fluid to be run at keep vein open rate.
~EVLW arm: Patients with a MAP > 60 and off vasopressors for >12 hours, as well as patients with a measured cardiac index >2.5 that also have a measured GEDI > goal."
11995616|NCT00624650|Drug|Diuresis (furosemide) part II|"Withhold furosemide if:
~Significant hypokalemia (K+ <= 2.5 meq/L), or hypernatremia (Na+ >= 155 meq/L) occurs within last 12 hours may then be restarted if the prevailing condition no longer exists
~Dialysis dependence
~Oliguria (less than 0.5ml/kg/hour) with either creatinine > 3, or clinical suspicion of rapidly evolving ARF
~More than 800mg has been given in less then 24 hours
~Creatinine increases > 1.5 mg/dl in any 24 hour period"
11995617|NCT00624650|Procedure|Dialysis|"Need for CVVHD or intermittent hemodialysis to be determined by treating clinicians.
~CVC arm: If fluid management to be accomplished with dialysis then fluid balance goals to be determined per clinicians.
~EVLW arm: Fluid balance as per algorithm
~When using intermittent HD it is recommended that no more than 2 liters net negative fluid is removed per dialysis session. Total fluid removal per run to be estimated by the clinicians to attain CVP or GEDI goals per algorithm."
11995618|NCT00624637|Other|aromatherapy massage|Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
11995619|NCT00624611|Procedure|Residual pump blood management post aortic cannula removal|Residual pump blood will be maximally hemoconcentrated by further ultrafiltation within the CPB machine. Resulting hematocrit will be approximately 0.4. The total residual pump blood volume, approximately 300ml, will be reinfused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Additional protamine sulfate will be given every 30 minutes during the infusion, .03 mg/ml of residual pump blood. Procedures in this group do not deviate from current standard practice.
11995620|NCT00624611|Procedure|Residual pump blood management post aortic cannula removal|All residual pump blood will be processed with a bedside red cell washing device (Cell Saver). The resulting total volume of concentrated red cells will be infused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Administration of additional protamine is not required due to the low concentrations of heparin in the resulting product.
11995621|NCT00624598|Behavioral|SMART|Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.
11995622|NCT00624585|Drug|Dasatinib|"DOSE ESCALATION OF DASATINIB AFTER 8 WEEKS IF ELIGIBLE
~Dose Level and Dose of dasatinib:
~Starting dose (1-8 weeks)= 100 mg orally (po) daily
~+1 (<8 weeks if no PR and well tolerated) = 150 mg po daily
~DOSE MODIFICATION OF DASATINIB
~Dose Level and Dose of dasatinib:
~Starting dose = 100 mg po daily
~-1 = 70 mg po daily
~-2 = 50 mg po daily
~OR
~Dose Level and Dose of dasatinib:
~Starting dose = 150 mg po daily
~-1 = 120 mg po daily
~-2 = 90 mg po daily
~-3 = 50 mg po daily"
11995623|NCT00624572|Drug|chlorexidine|Chlorexidine gel 1% during 7 days inside root canals
11995624|NCT00624559|Drug|celecoxib (Celebrex)|Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet
11995625|NCT00624559|Other|Placebo|Placebo pill taken twice per day on each day of the diet
11995626|NCT00624546|Drug|Prevacid Solutabs|BID Prevacid Solutabs
11995627|NCT00624546|Procedure|Antireflux surgery|Lap Nissen
11995628|NCT00624533|Behavioral|GDS Method (muscular chains physical therapy method)|Experimental group received 15 GDS method sessions based on the equilibration of articular and muscular tensions that reduced trunk and lumbopelvic stability. GDS method combine specific technics of manual therapy, spinal stabilisation and stretching exercises (4 sessions),supervised group exercise therapy (10 sessions) and home exercise programme with individualised exercises (1 session) Experimental group received 2 sessions of 50 minutes per week during 8 weeks.
11995680|NCT00624286|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
11995681|NCT00624273|Drug|Sildenafil therapy|oral use
11995629|NCT00624533|Behavioral|Conventional Physical Therapy in Primary Health Care|"Conventional Physical Therapy in Spanish Primary Care Units are based on Electrotherapy (TENS and microwave thermotherapy) and a standard written advices. Patients received 14 sessions of 40 minutes of conventional TENS, 10 minutes of microwave thermotherapy and 1 last session of standard written advices.
~Conventional Physical Therapy group received 2 sessions of 50 minutes per week during 8 weeks."
11995630|NCT00624520|Behavioral|Cognitive Behavioral Stress Management (CBSM)|10 week program of weekly CBSM therapy group sessions
11995631|NCT00624520|Other|Patient Education|"10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
11995632|NCT00624494|Device|Conventional monitoring|In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)
11995633|NCT00624494|Device|Advanced monitoring|In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.
11995634|NCT00624481|Drug|Teriparatide|20ug subcutaneous injection daily for 24 weeks
11995635|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
11995636|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
11995637|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
11995638|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
11995639|NCT00624468|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
11995640|NCT00624468|Drug|Placebo matched to atacicept|Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
11995641|NCT00624455|Drug|Gabapentin|One dose of oral premedication of Gabapentin 10 mg kg-1 given at least 30 but not more than 90 minutes before surgery. Max dose is 600mg.
11995642|NCT00624455|Drug|Placebo|Placebo
11995643|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.125 mg/kg/hr followed by 1 hour at 0.0625 mg/kg/hr
11995644|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.25 mg/kg/hr followed by 1 hour at 0.125 mg/kg/hr
11995645|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.5 mg/kg/hr followed by 1 hour at 0.25 mg/kg/hr
11995646|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.75 mg/kg/hr followed by 1 hour at 0.375 mg/kg/hr
11995647|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 1.0 mg/kg/hr followed by 1 hour at 0.5 mg/kg/hr
11995648|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.25 mg/kg/hr followed by 1 hour at 0.125 mg/kg/hr followed by 22 hours at 0.025 mg/kg/hr
11995649|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.5 mg/kg/hr followed by 1 hour at 0.25 mg/kg/hr followed by 22 hours at 0.05 mg/kg/hr
11995650|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 1.0 mg/kg/hr followed by 1 hour at 0.5 mg/kg/hr followed by 22 hours at 0.1 mg/kg/hr
11995651|NCT00624442|Drug|Placebo|I.V. infusion for 2 hours
11995652|NCT00624442|Drug|Placebo|I.V. infusion for 24 hours
11995653|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 1.0mg/kg/hr followed 1 hour at 0.5mg/kg/hr followed by 70 hours at 0.1mg/kg/hr
11995654|NCT00624442|Drug|Placebo|I.V. infusion for 72 hours
11995655|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.75 mg/kg/hr followed 1 hour at 0.5mg/kg/hr followed by 70 hours at 0.1 mg/kg/hr
11995656|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.25 mg/kg/hr followed by 23 hours at 0.025 mg/kg/hr
11995657|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 0.5 mg/kg/hr followed by 23 hours at 0.05 mg/kg/hr
11995658|NCT00624442|Drug|CK-1827452|I.V. infusion for 1 hour at 1.0 mg/kg/hr followed by 23 hours at 0.1 mg/kg/hr
11995659|NCT00624429|Drug|Budesonide respules|Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.
11995660|NCT00624416|Drug|Prednisolone synthetic cortisone and Isoproterenol together|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
11995661|NCT00624403|Device|Laryngeal mask insertion (LMA ProSeal)|Laryngeal mask insertion
11995662|NCT00624403|Device|Laryngeal mask insertion (I-Gel)|Laryngeal mask insertion
11995663|NCT00624390|Device|Sepraspray|
11995664|NCT00624377|Drug|Tiotropium|Tiotropium 18 mcg HandiHaler once daily
11995665|NCT00624364|Drug|biphasic insulin aspart|
11995666|NCT00624364|Drug|metformin|
11995667|NCT00624351|Biological|Epratuzumab|Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.
11995668|NCT00624351|Other|Placebo|Phosphate-buffered Saline (PBS) infusion.
11995669|NCT00624338|Drug|Atacicept 75 mg|75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
11995670|NCT00624338|Drug|Atacicept 150 mg|150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
11995671|NCT00624338|Other|Placebo Comparator|Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
11995672|NCT00624325|Drug|interferon alfa-2b|12 MU daily continuously subcutaneous
11995673|NCT00624325|Drug|interferon alfa-2b|9 MU daily continuously subcutaneous
11995674|NCT00624325|Drug|interferon alfa-2b|6 MU daily continuously subcutaneous
11995675|NCT00624312|Drug|Procrit|"10 days prior to surgery - injection of 60,000 IU of Procrit
~Day of surgery - injection of 60,000 IU of Procrit"
11995676|NCT00624312|Drug|Placebo|"10 days prior to surgery - injection with 60,000 IU of placebo
~Day of surgery - injection with 60,000 IU of placebo"
11995677|NCT00624299|Drug|Botox|Botox injection (100 ius) per muscle
11995678|NCT00624299|Other|Saline|Saline injection
11995683|NCT00624260|Other|PET-TDM for current indication|PET-TDM for current indication (high isolated markers or before a metastasis curative resection)
11995684|NCT00624247|Other|routine HIV testing|Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.
11995685|NCT00624234|Behavioral|Tutoring Program I|Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.
11995686|NCT00624234|Behavioral|Tutoring Program II|Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.
11995687|NCT00624221|Procedure|Descemet's stripping endothelial keratoplasty|Small incision corneal transplant procedure to treat dysfunctional endothelium.
11995688|NCT00624208|Drug|droperidol and saline|droperidol 20 mcg.kg-1 and saline
11995689|NCT00624208|Drug|ondansetron and saline|ondansetron 0.1 mg.kg-1 and saline
11995690|NCT00624208|Drug|droperidol and ondansetron|droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1
11995691|NCT00624208|Drug|saline and saline|saline and saline
11995692|NCT00624195|Drug|FDA Approved Antiretroviral Therapy (see list below)|"Combinations of FDA approved antiretroviral agents:
~Atripla, Combivir, Emtriva, Epivir, Epzicom, Retrovir, Trizivir, Truvada, Viread, Ziagen, Intelence, Rescriptor, Sustiva, Viramune, Agenerase, Aptivus, Invirase, Kaletra, Lexiva, Norvir, Prezista, Reyataz, Viracept, Fuzeon, Selzentry, Isentress
~Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
11995693|NCT00624182|Biological|Peptide vaccine for URLC10|Increasing the doses of URLC10 peptides will be administered by subcutaneous injection on day 1, 8, 15, and 22 of each 28-day treatment cycles. Doses of 0.5, 1.0, 2.0mg/body are planned. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.
11995694|NCT00624182|Drug|Gemcitabine|Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, and 15. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.
11995695|NCT00624169|Procedure|An optimized perioperative course|A number of interventions before, during and after surgery
11995696|NCT00624156|Behavioral|Writing Intervention|Participants in the emotional disclosure condition will be instructed to write continuously for 20 minutes about their deepest thoughts and feelings regarding their cancer experience.
11995697|NCT00624156|Behavioral|Writing Intervention|Participants assigned to the control condition will be instructed to describe in a detailed, nonemotional manner their daily activities. The 20-minute writing task will be introduced as a time management intervention
11995698|NCT00624143|Drug|ORAL VORICONAZOLE and IV Amphotericin B|Oral Voriconazole will be given in dose of 6mg/kg 12 hourly on day1 then 4mg/kg 12 hourly daily or IV Amphotericin B 0.5 mg/kg/day weekly thrice till the completion of induction or recovery of ANC >1000/MM3 or development of fungal infection
11995699|NCT00624130|Drug|Yasmin 20|Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
11995700|NCT00624130|Drug|Mercilon|Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)
11995701|NCT00624117|Behavioral|Progressive exercise|home-based exercise program, 2 to 3 exercise sessions per week
11995702|NCT00624104|Dietary Supplement|Food (fat free meal)|Fat free meal (40% of REE)
11995703|NCT00624091|Procedure|Cardiac surgery|Cardiac surgery within 48 hours of randomization
11995704|NCT00624091|Procedure|State-to-the-art treatment|Antibiotic treatment and surgery if emergency or sequelae of endocarditis as recommended in the guidelines
11995705|NCT00624078|Drug|Antivenin Centruroides (scorpion) F(ab)2 Anascorp™|three vials diluted in 20 to 50 mL normal saline administered intravenously. Subsequent single vial doses of Anascorp, up to a total of five vials administered at thirty minutes intervals until resolution of symptoms.
11995706|NCT00624065|Drug|carvedilol controlled release/lisinopril|carvedilol CR + lisinopril given as separate pills
11995707|NCT00624065|Drug|lisinopril + placebo|lisinopril plus placebo to match carvedilol CR
11995708|NCT00624052|Drug|fixed-dose combination of telmisartan 40mg+amlodipine 10mg|
11995709|NCT00624052|Drug|fixed-dose combination of telmisartan 80mg+amlodipine10mg|
11995710|NCT00624039|Other|UBM with pilocarpine in presbyopia|ultrasound biomicroscopic examination in both eyes 30 minutes after one drop of 2% pilocarpine hydrochloride (Ocucarpine®, Samil Pharm., Seoul, Korea) instillation before and two months after cataract surgery
11995711|NCT00624026|Drug|Memantine-HCl|20 mg per day (once daily)
11995712|NCT00624013|Drug|sertraline|50 mg up to 100 mg daily for 6 months
11995713|NCT00624013|Drug|Placebo|50 mg up to 100 mg daily for 6 months
11995714|NCT00624000|Drug|IV tpa (Alteplase) vs IA tpa (Alteplase)|Alteplase was administered Either IA or IV x 1
11995715|NCT00623987|Drug|warfarin accordingly INR value|warfarin accordingly to INR value between 2.0-3.0
11995716|NCT00623974|Drug|Teriparatide (Forteo)|Subcutaneous Injection Every 12 Hours for 7 Days
11995717|NCT00623974|Drug|Calcium|1000 milligrams by mouth (PO) Every 12 Hours
11995718|NCT00623974|Drug|Calcitriol|0.25 micrograms PO Every 12 Hours
11995719|NCT00623948|Device|A fully implanted gluteal stimulation (GSTIM) system|A fully implanted gluteal stimulation system
11995720|NCT00623935|Drug|Fludarabine|Fludarabine (40 mg/m2/day x 4 days)
11995721|NCT00623935|Drug|Busulfan|Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
11995722|NCT00623935|Radiation|Total Body Irradiation|Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.
11995723|NCT00623935|Procedure|Stem Cell Transplant|Allogeneic stem cell transplant from related or unrelated donor
11995724|NCT00623922|Behavioral|Patient education with individual nurse consultations|3 group meetings followed by 1-2 individual nurse consultations.
11995725|NCT00623909|Device|AvicennaTM class IV laser application|AvicennaTM class IV laser for application over the skin of human subjects in the treatment of post-thoracotomy pain syndrome. Six sessions, twenty minutes applications over a period of six weeks.
11995726|NCT00623883|Procedure|Surgical removal of ACF|All ACF removed by either cold or hot colonoscopic biopsy forceps
11995727|NCT00623883|Procedure|Colonoscopic evaluation only|Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year
11995728|NCT00623870|Drug|RO5045337|Multiple ascending doses
11995729|NCT00623857|Dietary Supplement|Zinc|Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
11995730|NCT00623857|Dietary Supplement|Vitamins and minerals other than zinc|Daily supplementation with vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks
11995731|NCT00623857|Dietary Supplement|Vitamins plus zinc and other minerals|Daily oral supplementation with zinc, vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks
11995732|NCT00623857|Dietary Supplement|Placebo|Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks
11995733|NCT00623844|Behavioral|physical activity|activity program at kindergarten 5 * 30 min per week plus education of parents (letters, flyers, presentations, counselling) plus activity homework for children involving also the families
11995734|NCT00623831|Biological|Mixed bacterial vaccine|MBV was administered twice weekly by subcutaneous injection in Cohort 1 and by intralesional (preferred) or subcutaneous (if intralesional not possible) injection in Cohort 2. In Cohort 1, the MBV starting dose was 250 EU (dose level 1) with possible intrasubject escalations up to 547,000 EU (dose level 8). In Cohort 2, all subjects received MBV at a fixed dose of 60,800 EU (dose level 6).
11995735|NCT00623805|Drug|Bevacizumab|Bevacizumab was supplied as a solution in single-use vials.
11995736|NCT00623805|Drug|Capecitabine|Capecitabine was supplied as film-coated tablets.
11995737|NCT00623805|Drug|Oxaliplatin|Oxaliplatin was supplied as a lyophilized powder in vials.
11995738|NCT00623792|Behavioral|Preoperative lifestyle Intervention|"6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 booster telephone calls after surgery"
11995739|NCT00623779|Drug|AZD0837|ER formulation
11995740|NCT00623779|Drug|Aspirin|Oral form
11995741|NCT00623766|Drug|Ipilimumab|10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance
11995742|NCT00623766|Drug|Corticosteroid: Betamethasone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with betamethasone
11995743|NCT00623766|Drug|Corticosteroid: Dexamethasone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with dexamethasone
11995744|NCT00623766|Drug|Corticosteroid: Fludrocortisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with fludrocortisone
11995745|NCT00623766|Drug|Corticosteroid: Hydrocortisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with hydrocortisone
11995746|NCT00623766|Drug|Corticosteroid: Meprednisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with meprednisone
11995747|NCT00623766|Drug|Corticosteroid: Methylprednisolone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with methylprednisolone
11995748|NCT00623766|Drug|Corticosteroid: Prednisolone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisolone
11995749|NCT00623766|Drug|Corticosteroid: Prednisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisone
11995750|NCT00623766|Drug|Corticosteroid: Triamcinolone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with triamcinolone
11995751|NCT00623753|Biological|EnvDNA, PolyEnv1, EnvPro|Description: The vaccine regimen is a series of 6 injections given 28 days apart. EnvDNA is administered intramuscularly as 100 mcg of recombinant DNA in 1.5 mL of PBS as injections #1, 2 and 5. PolyEnv1 is recombinant vaccinia virus administered subcutaneously as 107 pfu in 0.8 mL of PBS as injection #3. EnvPro is administered intramuscularly as 100 mcg of recombinant protein and 500 mcg of aluminum hydroxide (alum) adjuvant in 1.0 mL of PBS as injections #4 and 6.
11995752|NCT00623740|Drug|hydrocortisone|Intravenous slow of hemisuccinate hydrocortisone 0.5 mg/kg/12 hours during 7 days then 0.5mg/kg/24 hours during 3 days.
11995753|NCT00623740|Drug|placebo|intravenous slow of placebo 0.5mg/kg/12 hours during 7 days then 0.5 mg/kg/24 hours during 3 days
11995754|NCT00623727|Biological|rFVIII-FS/pegylated liposomes (BAY79-4980)|35 IU/kg body weight intravenous 1x/week for 52 weeks This arm will be stopped by 30.04.10 the subjects will be offered to change to the active comparator arm
11995755|NCT00623727|Biological|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight intravenous 3x/week for 52 weeks
11995756|NCT00623714|Drug|Comparator: fluticasone|Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
11995757|NCT00623714|Drug|Placebo|Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
11995758|NCT00623701|Biological|Allerslit forte|sublingual placebo preparation, daily
11995759|NCT00623701|Biological|Allerslit forte|Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
11995760|NCT00623688|Device|Metered Dose Inhaler & Optichamber Advantage Valve Holding Chamber (VHC)|Albuterol is delivered by metered dose inhaler with valved holding chamber. For children less than 6 years of age, a mask is also used.
11995761|NCT00623688|Device|Airlife Sidestream High Efficiency Nebulizer|Albuterol is delivered as a mist mixed with normal saline using a nebulizer machine and face mask or mouth piece.
11995762|NCT00623675|Dietary Supplement|Mineralox C|Mineralox C 2 capsules three times a day.
11995763|NCT00623662|Other|Preoperative glucose infusion|Glucose infusion from 15:00 on the day before the operation until beginning of surgery.
11995764|NCT00623662|Other|Preoperative normal saline infusion|Normal saline infusion from 15:00 on the day before surgery until beginning of the operation.
11995765|NCT00623649|Drug|VCH 916|Dose escalation study with a full review of all safety data following each cohort.
11995766|NCT00623649|Drug|Placebo|Dose escalation study with a full review of all safety data following each cohort.
11995767|NCT00623636|Drug|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.
11995768|NCT00623636|Drug|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.
11995769|NCT00623623|Procedure|primary PCI|Standard primary PCI
11995770|NCT00623623|Drug|enoxaparin|Adjunctive treatment
11995771|NCT00623623|Procedure|catheterisation|Routine or rescue coronary intervention
11995772|NCT00623623|Drug|tenecteplase|Single, weight-adjusted i.v. bolus of tenecteplase
11995773|NCT00623623|Drug|clopidogrel|Adjunctive treatment
11995774|NCT00623610|Procedure|islet cell grafts|Intraportal injection of an islet cell graft into the liver.
11995775|NCT00623597|Drug|ritonavir|2.5-3.0mg/kg po bid (starting dose) for 48 weeks
11995776|NCT00623597|Drug|saquinavir [Invirase]|50mg/kg po bid (starting dose) for 48 weeks
11995777|NCT00623584|Procedure|Corneal transplantation|Full thickness penetrating keratoplasty
11995778|NCT00623584|Procedure|Corneal transplantation|Full thickness penetrating keratoplasty
11995779|NCT00623571|Other|Treatment of elderly patients in a GMW|
11995780|NCT00623571|Other|Treatment of elderly patients in GHHS|
11995781|NCT00623558|Drug|Cetuximab|400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks
11995782|NCT00623558|Drug|Docetaxel|75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
11995783|NCT00623558|Drug|Cisplatin|75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
11995784|NCT00623545|Drug|Exenatide|Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
11995785|NCT00623532|Behavioral|Mind-body exercises|
11995786|NCT00623532|Behavioral|Adapted Tai-chi|
11995787|NCT00623506|Drug|Pregnenolone|"Placebo for two weeks (during placebo lead-in), then:
~Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
11995788|NCT00623506|Drug|Placebo|"Placebo for two weeks (placebo lead in), then:
~Placebo equivalent to Pregnenolone arm: 100 mg in divided doses (50 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 300 mg in divided doses (150 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 500 mg in divided doses (250 mg, PO, BID)"
11995789|NCT00623480|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
11995790|NCT00623480|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Treated according to the Kogenate FS package insert indications and study physician recommendations
11995791|NCT00623467|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.
11995792|NCT00623454|Behavioral|Cognitive behaviour therapy|Three hours with cognitive therapy focusing on the chest pain and palpitations.
11995793|NCT00623441|Device|Endeavor Zotarolimus Eluting Coronary Stent|Drug eluting stent
11995794|NCT00623428|Drug|peginterferon alfa-2a|
11995795|NCT00623428|Drug|Ribavirin|
11995796|NCT00623415|Drug|Flupirtine|300 mg daily (divided in two doses)
11995797|NCT00623415|Drug|Placebo|twice daily
11995798|NCT00623402|Drug|Sorafenib|2x 400 mg orally per day (4 tablets)
11995799|NCT00623402|Drug|pegylated interferon α-2b|3 µg/kg body weight s.c. once a week
11995800|NCT00623389|Device|IST-16 (16-channel implanted stimulator-telemeter)|Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and IST-16 stimulator/telemeter implantation, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
11995801|NCT00623376|Drug|nabilone then placebo|The subjects were first on Nabilone, then crossed over to placebo
11995802|NCT00623376|Drug|placebo then nabilone|the subjects were first on placebo then crossed over to nabilone
11995803|NCT00623363|Drug|piclozotan|piclozotan, IV
11995804|NCT00623363|Drug|0.9% sodium chloride (normal saline)|0.9% sodium chloride (normal saline)
11995805|NCT00623350|Other|Telephone|Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
11995806|NCT00623350|Other|Two way audio/video telemedicine consult|Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
11995807|NCT00623337|Behavioral|Home visits|Home visits by community based surveillance volunteers (2 during pregnancy & 3 during 1st week of life) to promote facility delivery, careseeking during pregnancy and childbirth and essential newborn care practices and to identify & refer sick babies
11995808|NCT00623324|Drug|Aplindore|Tablets .05 - 5 mg BID dosing for 14 days
11995809|NCT00623324|Drug|Placebo|Placebo tablets to match the number of active tablets
11995810|NCT00623298|Behavioral|Narrative Exposure Therapy|
11995811|NCT00623298|Behavioral|group IPT|
11995812|NCT00623298|Other|6 months-baseline|
11995813|NCT00623285|Drug|Pregabalin|Pregabalin 150mg orally 60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive 150mg twice a day through the first 2 post-operative days for a total of six doses.
11995814|NCT00623285|Drug|Placebo/Lactose|Matching Placebo orally,60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive placebo twice a day through the first 2 post-operative days for a total of six doses. If the patient is unable to swallow and NG tube is in place, the medication can be dissolved in water and administered through the NG tube.
11995815|NCT00623272|Other|compare measurements of left ventricular volumes and LVEF (by Cardiac Magnetic Resonance and Echocardiography)|To compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction.
11995816|NCT00623259|Biological|MVA-mBN120B|
11995817|NCT00623246|Behavioral|MET|MET will involve motivational counseling sessions and phone calls, with a focus on building self-efficacy and providing personalized feedback on health and adherence patterns based on CPAP adherence monitoring.
11995818|NCT00623246|Behavioral|ED|ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
11995819|NCT00623233|Drug|Gemcitabine|Gemcitabine 2500 mg/m^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.
11995820|NCT00623233|Drug|Bevacizumab|"Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event [AE], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.)
~Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
11995821|NCT00623220|Other|N2O|EMONO
11995822|NCT00623220|Other|oxygen|oxygen
11995823|NCT00623207|Drug|Atropine|I.V Atropine 0.5mg up to 2 mg
11995824|NCT00623194|Drug|insulin detemir|Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.
11995825|NCT00623194|Drug|insulin aspart|Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.
11995826|NCT00623181|Biological|Fluzone: Influenza virus vaccine|0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
11995827|NCT00623181|Biological|Fluzone: Influenza virus vaccine|0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid
11995828|NCT00623168|Drug|Ribavirin|7 Day multiple dosing regime based on weight and dosage day
11995829|NCT00623155|Drug|Seasonal IPT in children - Sulfadoxine-pyrimethamine|Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
11995830|NCT00623142|Drug|Hyperbaric Oxygen|100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG
11995831|NCT00623129|Other|questionnaire administration|
11995832|NCT00623129|Procedure|electroacupuncture therapy|
11995833|NCT00623129|Procedure|management of therapy complications|
11995834|NCT00623129|Procedure|quality-of-life assessment|
11995835|NCT00623116|Drug|Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)|clinical examination, biochemical profile, and genetic characterization. Possibility to stop hormone therapy with drugs containing testosterone (Atmos®, Testim®, Testogel®, Nebido®, Panteston®, Sustanon®), FSH (Gonal-F®, Puregon®), hCG (Pregnyl®), estrogenic compounds (such as Estrofem®, Divigel®, Estrena®, Climara®, Estradot®, Evorel®, Femseven®: Merimono®, Progynova®, Ovestin®, Zumenon®, Estrogel®, Femoston®, Femoston combi®, Divina®, Divitren®, Indivina®, Estalis sekvens®, Evorel sequi®, Novofem®, Trisekvens®, Activelle®, Estalis®, Evorel conti®, Kliogest®, Mericomb®, Mericomb Mite®, Merigest®: Angeliq®) for 3 mo to assess reversibility of GnRH-deficiency will be offered.
11995836|NCT00623103|Drug|Rivastigmine capsule|Rivastigmine capsules orally twice a day. Target dose 12 mg/day.
11995837|NCT00623103|Drug|Rivastigmine transdermal patch|Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm^2/day delivering 9.5 mg over a 24 hour period.
11995838|NCT00623090|Behavioral|educational internet site on prostate cancer screening|Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.
11995839|NCT00623090|Behavioral|Educational print booklet|Healthy men between 45-70 receive a copy of our educational print booklet in the mail.
11995840|NCT00623090|Behavioral|Usual care|Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.
11995841|NCT00623077|Biological|filgrastim|"Beginning 24 hours after chemotherapy end: 10 microgram/kg/day subcutaneously (SQ) or intravenously (IV) until absolute neutrophile count (ANC) > 1,000/mm^2.
~Starting that day, increase dose to 15 microgram/kg/day SQ or IV given as a single injection for 3 doses."
11995842|NCT00623077|Drug|busulfan|Part of pre-transplant conditioning chemotherapy: Administered as Busulfan 9.6 mg/kg IV (>4 yrs of age) or 13.2 mg/kg IV (< 4 years of age),every 6 hours on Days -8 through -6.
11995843|NCT00623077|Drug|etoposide|Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 100 mg/m^2/day intravenous (IV) over 1 hour for 5 days.
11995844|NCT00623077|Drug|ifosfamide|Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m^2/day intravenous (IV) over 1 hour on for 5 days.
11995845|NCT00623077|Drug|melphalan|Part of pre-transplant conditioning chemotherapy: Administered as 100 mg/m^2 intravenous (IV) over 30 min on Days -5 through -4.
11995846|NCT00623077|Drug|thiotepa|Part of pre-transplant conditioning chemotherapy: Administered as 500 mg/m^2 intravenously (IV) over 2 hrs on Days -3 through -2.
11995847|NCT00623077|Procedure|stem cell transplantation|Regardless of whether the patient will be receiving peripheral cells or bone marrow, infusion will be intravenous on day 0, immediately after thawing.
11995848|NCT00623077|Radiation|tomotherapy|"We plan to deliver the total marrow irradiation (TMI) to the upper half of the body using Tomotherapy TMI as explained in this protocol. However the lower part of the body will be treated with Anterior/Posterior linac based radiation treatment. Tomotherapy will then be delivered at a dose rate so as to keep the total treatment time to no more than 30 minutes. We anticipate that the dose rate will be around 400 cGy
~/minute (instantaneous dose rate)."
11995849|NCT00623077|Radiation|total marrow irradiation|"TMI will be delivered to all bony sites as part of the conditioning. Additional spot therapy to PET positive lesions, primary disease (if not previously irradiated to maximum tolerated dose), and lungs will be performed on Day +60. Cohorts of 3 patients will be treated at a total dose of 600 cGy, 900 cGy or 1200 cGy on Days -11 through -9."
11995850|NCT00623077|Drug|Mesna|Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m^2/day divided in every 6 hrs dosing for 5 days.
11995851|NCT00623077|Radiation|Whole lung radiation|At Day 60, patients with prior lung metastasis should receive whole lung irradiation (1500cGy in 10 fractions).
11995852|NCT00623064|Drug|cisplatin|
11995853|NCT00623064|Drug|gemcitabine hydrochloride|
11995854|NCT00623064|Drug|lapatinib ditosylate|
11995855|NCT00623064|Other|pharmacological study|
11995856|NCT00623051|Procedure|Male Circumcision|
11995857|NCT00623025|Drug|Creon 25000|6 to 9 capsules Creon 25000 per day
11995858|NCT00623025|Drug|Placebo|6 to 9 capsules placebo per day
11995859|NCT00623012|Drug|Rapamycin|Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
11995860|NCT00623012|Drug|Tacrolimus|Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks.
11995861|NCT00622986|Drug|an extract of Cimicifuga Foetida L.|Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
11995862|NCT00622986|Drug|an extract of Cimicifuga Foetida L.|Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
11995863|NCT00622986|Drug|placebo|Each patient will be given placebo of 2 tablets each day for 3 months.
11995864|NCT00622986|Drug|placebo|Each patient will be given placebo of 2 tablets each day for 3 months.
11995865|NCT00622973|Other|Imaging: diffusion-weighted MRI|Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
11995866|NCT00622973|Other|Sinerem (USPIO) enhanced MRI|USPIO (Sinerem) will be administered intravenously immediately after the first MR examination at a dose of 2.6 mg Fe/kg body weight diluted in 100 ml of saline (optimal dose according to: (9, 10)) during a period of about 30 minutes under medical supervision. Postcontrast MR imaging will be performed 24-36 hours after contrast medium injection.
11995867|NCT00622960|Other|High-MUFA diet|The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.
11995868|NCT00622960|Other|High-CHO diet|The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.
11995869|NCT00622947|Procedure|right temporal low frequency (1 hz) rTMS|Right temporal low frequency (1 hz) rTMS.
11995870|NCT00622947|Procedure|Sham-rTMS|The coil is angled 90 degrees away from the scalp
11995871|NCT00622934|Drug|erythropoietin|300mg/kg erythropoietin 3 times on the first week of admission
11995872|NCT00622934|Drug|placebo|placebo
11995873|NCT00622921|Behavioral|Couples-based behavioral psychotherapy|12 weeks of Couples-based behavioral psychotherapy
11995874|NCT00622908|Drug|ISV-403|0.6% TID, 5 days
11995875|NCT00622908|Drug|Vehicle|Vehicle of ISV-403 TID, 5 days
11995876|NCT00622895|Drug|fludarabine phosphate|Given IV
11995877|NCT00622895|Drug|Mycophenolic Acid|Given PO
11995878|NCT00622895|Drug|tacrolimus|Given PO
11995879|NCT00622895|Radiation|total-body irradiation|Undergo TBI
11995880|NCT00622895|Procedure|bone marrow transplantation|Undergo transplantation
11995881|NCT00622895|Procedure|reduced intensity allogeneic hematopoietic stem cell transplantation|Undergo transplantation
11995882|NCT00622895|Procedure|quality-of-life assessment|Ancillary studies
11995883|NCT00622895|Other|laboratory biomarker analysis|Correlative studies
11995884|NCT00622895|Other|flow cytometry|Correlative studies
11995885|NCT00622895|Procedure|biopsy|Punch biopsy of skin involved with scleroderma
11995886|NCT00622882|Other|infectious disease specialist consultation|Randomised trial to determine the utility of an early Infectious disease Consultation in Staphylococcus aureus bacteremic patients ( in the first 48 hours of a positive blood culture)
11995887|NCT00622869|Drug|Tacrolimus (reduced tacrolimus)|After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization, a level which was maintained for the duration of the study.
11995918|NCT00622687|Drug|iloprost|0.5-2 ng/kg x min for 6hours a day for 21 consecutive days
11995919|NCT00622687|Drug|iloprost low dose|0.5 ng/kg x min over 6 h per day for 21 consecutive days
11995888|NCT00622869|Drug|Tacrolimus (tacrolimus elimination)|After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization. Tacrolimus elimination was started beginning at Month 4. Tacrolimus was tapered after everolimus whole blood trough levels were within the target range of 6-10 ng/mL. Tacrolimus was completely eliminated by the end of Month 4.
11995889|NCT00622869|Drug|Tacrolimus (tacrolimus control)|Tacrolimus trough levels were targeted to be maintained at 8-12 ng/mL until Month 4. At Month 4, tacrolimus whole blood trough levels were decreased to a target trough level of 6-10 ng/mL for the remainder of the study.
11995890|NCT00622869|Drug|Everolimus (reduced tacrolimus)|Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL for the duration of the study.
11995891|NCT00622869|Drug|Everolimus (tacrolimus elimination)|Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL until Month 4; beginning with Month 4, the dose was adjusted to maintain everolimus trough blood levels between 6-10 ng/mL.
11995892|NCT00622869|Drug|Corticosteroids|For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids could be used for the duration of the study but could not be eliminated before Month 6.
11995893|NCT00622856|Behavioral|psychological intervention|Psychological intervention
11995894|NCT00622856|Behavioral|Diabetes education|5 sessions with diabetes nurse
11995895|NCT00622843|Biological|pneumococcal conjugate vaccine|"Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain:
~2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension."
11995896|NCT00622843|Biological|pneumococcal polysaccharide vaccine|PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
11995897|NCT00622830|Drug|SB-480848 (Darapladib)|
11995898|NCT00622817|Drug|xylometazoline HCL 0.05%|Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.
11995899|NCT00622817|Drug|Epinephrine 1mg|Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
11995900|NCT00622804|Procedure|Billroth-II (B-II)|After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.
11995901|NCT00622804|Procedure|Roux en Y gastrojejunostomy (RY-GJ)|After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.
11995902|NCT00622804|Procedure|uncut Roux en Y gastrojejunostomy|After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.
11995903|NCT00622765|Drug|placebo|Placebo capsule twice daily
11995904|NCT00622765|Drug|R256918|5 mg capsule twice daily
11995905|NCT00622765|Drug|R256918|10 mg capsule twice daily
11995906|NCT00622765|Drug|R256918|15 mg capsule twice daily
11995907|NCT00622752|Drug|EVT 302, 10 mg|2 X EVT 302, 5 mg tablets
11995908|NCT00622752|Drug|placebo|2 X placebo tablets to match EVT 302 5 mg
11995909|NCT00622752|Drug|Nicotine replacement therapy (NRT)|NRT patch containing 21 mg of nicotine
11995910|NCT00622752|Device|NRT placebo|Medically inert plaster cut to match the NRT plaster
11995911|NCT00622739|Drug|Ziprasidone|Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
11995912|NCT00622739|Drug|Ziprasidone|Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
11995913|NCT00622726|Drug|Bevacizumab|Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
11995914|NCT00622726|Procedure|Conventional Laser for ROP|Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)
11995915|NCT00622713|Drug|Rivastigmine transdermal patch|The study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
11995916|NCT00622700|Drug|Teriflunomide|Film-coated tablet Oral administration
11995917|NCT00622700|Drug|Placebo|Film-coated tablet Oral administration
11996895|NCT00616070|Drug|Difluprednate|Difluprednate
11995920|NCT00622687|Drug|iloprost therapy up to 2 ng/kg x min|starting therapy at doses of 0.5 ng/kg x min, increase the dose every two days for 0.5 ng/kg x min up to the maximally tolerated dose or to 2 ng/kg x min
11995921|NCT00622674|Biological|cetuximab|A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
11995922|NCT00622674|Drug|bortezomib|The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.
11995923|NCT00622661|Other|Low Glycemic Load Diet|consume both high and low glycemic load diets for 28 days each
11995924|NCT00622661|Other|High Glycemic Load Diet|consume both high and low glycemic load diets for 28 days each
11995925|NCT00622648|Drug|Enoxaparin|40 mg once daily for 6 to 14 days (10 ± 4 days)
11995926|NCT00622648|Drug|Placebo|Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)
11995927|NCT00622635|Drug|Indacaterol 300 μg|Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).
11995928|NCT00622635|Drug|Placebo to indacaterol|Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).
11995929|NCT00622635|Drug|Salmeterol 50 μg|Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).
11995930|NCT00622622|Biological|VEGFR2-169 and gemcitabine|Escalating doses of VEGFR2-169 will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles(doses of 0.5,1.0,2.0mg/body are planned). Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days 1,8 and 15. Repeated cycles of VEGFR2-169 and gemcitabine will be administered until patients develop progressive disease or unacceptable toxicity,or for maximum 2 cycles, whichever occurs first.
11995931|NCT00622609|Drug|GSK249320A|GSK249320A intravenous infusion will be formulated as 100 milligrams/milliliters in 2 milliliters vials (filled to 1 milliliter), in phosphate buffer and delivered by a syringe and programmable pump.
11995932|NCT00622609|Drug|Placebo|Sodium chloride intravenous infusion will be given as matching placebo.
11995933|NCT00622596|Other|Mobile Access|Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.
11995934|NCT00622570|Drug|Pentobarbital|10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
11995935|NCT00622570|Drug|thiopental|"2 mg/kg in bolus; if ICP is not below 20 mmHg then 3 mg/kg in bolus; if ICP is not below 20 mmHg it can be administrated a third bolus of 5 mg/kg.
~Maintenance: 3 mg/kg/h in perfusion"
11995936|NCT00622531|Device|BNP assay (Siemens ADVIA Centaur BNP)|Diagnostic test
11995937|NCT00622531|Other|hidden BNP value|no intervention
11995938|NCT00622518|Drug|Hyland's earache drops|3-4 drops in affected ear 3 times a day as needed for up to 5 days
11995939|NCT00622505|Drug|zoledronic acid|4 mg either 4 or 12 weeks for 96 weeks
11995940|NCT00622492|Other|echocardiography Doppler sonography, blood and urine sampling|data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO
11995941|NCT00622479|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib will be administered at 400mg BID for a 28 day cycle.
11995942|NCT00622466|Drug|paclitaxel|The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
11995943|NCT00622466|Drug|sorafenib tosylate|Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
11995944|NCT00622453|Other|Screening|Electrocardiography Blood Test
11995945|NCT00622440|Drug|AIJP (Arnebia Indigo Jade Pearl)|Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
11995946|NCT00622440|Drug|Placebo|Placebo twice daily for 48 weeks.
11995947|NCT00622427|Drug|Ramelteon|8 mg tablets every night for 2 weeks
11995948|NCT00622427|Drug|Placebo|placebo tablets for every night for 2 weeks
11995949|NCT00622414|Biological|ziv-aflibercept|Given IV
11995950|NCT00622401|Biological|Dendritic Cell/Tumor Fusion Vaccine|Vaccine is derived from the participants dendritic cells and tumor cells
11995951|NCT00622401|Drug|Interleukin-12|Given subcutaneously at dose of 30ng/kg
11995952|NCT00622401|Drug|Interleukin-12|Given subcutaneously at dose of 100ng/kg
11995953|NCT00622388|Drug|Ofatumumab|8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
11995954|NCT00622375|Drug|mesalamine|encapsulated mesalamine granules
11995955|NCT00622362|Biological|DEPIGOID Dermatophagoides pteronyssinus|Subcutaneous administration:0.5 ml/month during 1 year
11995956|NCT00622362|Biological|Polymerized TOL of Dermatophagoides pteronyssinus|Sublingual immunotherapy. Two drops daily during 1 year
11995957|NCT00622362|Biological|Placebo Comparator|Sublingual immunotherapy. Two drops daily during 1 year
11995958|NCT00622349|Drug|Cisplatin, Ifosfamide, Gemcitabine|Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
11995959|NCT00622349|Drug|Ifosfamide, Gemcitabine|Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
11995960|NCT00622349|Drug|Cisplatin, docetaxel|Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks
11995961|NCT00622336|Drug|CC-5013|Oral 25mg daily on Days 1-21 every 28 days.
11995962|NCT00622336|Drug|Lenalidomide|Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.
11995963|NCT00622310|Behavioral|Walking exercise|Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program. Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.
11995964|NCT00622284|Drug|Placebo identical to BI 1356 5mg|Placebo tablet once daily
11995965|NCT00622284|Drug|Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg|Placebo tablets once daily
11995966|NCT00622284|Drug|BI 1356|5mg, once daily in the morning for 104 weeks
11995967|NCT00622284|Drug|Glimepiride|1mg or 2mg or 3mg or 4mg in the morning for 104 weeks
11996016|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
11996017|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
11995968|NCT00622271|Behavioral|Group Therapy|Self-management Group Protocol: The parent sessions will be structured by general topic area, but teaching of clinical and behavioral information will be derived from questions and problems posed by the group in order to actively meet the needs and concerns of participants. The parent sessions will be an interactive process of eliciting concerns and questions, presenting information to address those questions, and following up with a discussion to review concerns and strategies to address the behavioral aspects of the issues. The child sessions will be activity focused, with hands-on opportunities to practice the skills being taught.
11995969|NCT00622258|Drug|Everolmus|
11995970|NCT00622245|Drug|Lu AA34893|per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
11995971|NCT00622245|Drug|Quetiapine fumarate|per oral, once daily, during 12 weeks, followed by a one-week tapering period
11995972|NCT00622245|Drug|Placebo|per oral doses, twice daily as capsules during 13 weeks
11995973|NCT00622232|Genetic|VRX496-transduced autologous CD4 T cells|The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.
11995974|NCT00622219|Other|Randomized Drug Testing Trial|Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).
11995975|NCT00622206|Drug|ritonavir and saquinavir|saquinavir/ritonavir 1500/100 mg or 1500/50 mg Twenty HIV-infected volunteers on stable doses of SQV/RTV 1500/100 mg OD for at least 3 months with an NRTI backbone and undetectable viral load will participate. After collecting samples for a full PK curve subjects will be switched to SQV/RTV 1500 /50 mg OD + 2NRTIs for 1 week before repeating the PK assessment. Blood samples will be drawn at T 0, 1, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion. Consecutively to the assessment, subjects will return to SQV/RTV 1500/100 mg OD dosage.
11995976|NCT00622193|Drug|anamorelin HCl|50 mg tablet
11995977|NCT00622193|Drug|anamorelin HCl|100 mg tablet
11995978|NCT00622193|Drug|placebo|placebo tablet
11995979|NCT00622180|Device|NBUVB|NBUVB hand foot box
11995980|NCT00622180|Device|Monochromacitc Excimer light|Treatment with Monochromacitc Excimer light
11995981|NCT00622167|Device|Integrated Backscatter IVUS|All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
11995982|NCT00622167|Device|Dual Source Computed Tomography|All subjects have DSCT and IBIVUS imaging
11995983|NCT00622141|Drug|generic GPO saquinavir and novir vs invirase and norvir|Norvir® 100mg capsules, Invirase® 1,000 mg capsules Generic GPO Saquinavir 1,000 mg capsules For phase 1 and 2 - At day 1 subjects of group A will receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg, while group B will receive generic GPO saquinavir / Norvir® 1,000 mg / 100mg as single dose. The same day the first 24 hr PK curve will be done. After this, a 7-day washout period will follow. At day 8 group A will take generic GPO saquinavir / Norvir® and Group B will take Invirase®/Norvir®. At this day, the second 24 hr PK curve will be done
11995984|NCT00622128|Behavioral|Preventing Aggressive Behavior in Demented Patients|Preventing Aggressive Behavior in Demented Patients
11995985|NCT00622115|Drug|Enoxaparin|
11995986|NCT00622102|Behavioral|Lottery arm (Lottery and Med-eMonitor)|Lottery and Med-eMonitor
11995987|NCT00622102|Behavioral|Non-Lottery (Med-eMonitor only)|Med-eMonitor only
11995988|NCT00622089|Drug|DIO-902|150mg DIO-902 + 10mg atorvastatin
11995989|NCT00622089|Drug|DIO-902|300mg dose once per day for 24 weeks
11995990|NCT00622089|Drug|DIO-902|450mg dose once per day for 24 weeks
11995991|NCT00622076|Procedure|postoperative catheterization|postoperative catheterization after anterior colporrhaphy for five days versus two days.
11995992|NCT00622063|Drug|ARQ 501|Treatment with ARQ 501 or ARQ 501 as combination therapy at the dose and regimen previously received
11995993|NCT00622050|Behavioral|No TV viewing reduction|In the control group, no intervention will be acted upon. This group will receive the exact same protocol as the intervention group, but with observation only.
11995994|NCT00622050|Behavioral|TV viewing reduction|In the experimental arm, TV viewing time will be reduced for half of the study protocol time (3-4 weeks of a 6-8 week protocol).
11995995|NCT00622037|Drug|PEG-400 based artificial tear|Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
11995996|NCT00622037|Drug|Systane|Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
11995997|NCT00622011|Drug|Risperidone and Zotepine for delirium|try risperidone or zotepine in the treatment of delirium
11995998|NCT00621998|Drug|risperidone|0.5-6 mg/day
11995999|NCT00621998|Drug|olanzapine|2.5-20 mg/day
11996000|NCT00621985|Drug|dexamethasone|Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days.
11996001|NCT00621985|Drug|Hydrocortisone|Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen.
11996002|NCT00621959|Drug|levocetirizine dihydrochloride|5mg daily (oral tablet) for 14 days
11996003|NCT00621959|Drug|placebo|0mg (matching oral tablet)for 14 days
11996004|NCT00621946|Drug|Placebo|Placebo Matching Escitalopram
11996005|NCT00621946|Drug|Escitalopram|Active Escitalopram
11996006|NCT00621920|Drug|FM-601|Dose-escalation, split dosage, liquid
11996007|NCT00621907|Drug|chirocaine (Levobupivacaine)|levobupivacaine 0,5 % 30 ml infiltration (150 mg)
11996008|NCT00621907|Drug|sodium chloride|sodium chloride : 0,9% 30 ml
11996009|NCT00621894|Drug|LGD-4665|LGD-4665 Thrombopoietin mimetic
11996010|NCT00621894|Drug|Placebo|Placebo
11996011|NCT00621881|Drug|naproxcinod|750 mg bid
11996012|NCT00621868|Drug|ipragliflozin|Oral
11996013|NCT00621868|Drug|Placebo|Oral
11996014|NCT00621855|Drug|placebo|matched placebo
11996015|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
11996018|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
11996019|NCT00621842|Drug|Lamotrigine regular tablet formulation|Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.
11996020|NCT00621842|Drug|Lamotrigine novel formulation|"Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used.
~Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds."
11996021|NCT00621829|Dietary Supplement|EPA enriched fish oils|Subjects will take the (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA) supplements as a capsule (3-4 g of EPA/day) for 90 days, followed by an 8 week washout period, and then will take a Placebo capsule for 90 days.
11996022|NCT00621829|Dietary Supplement|EPA enriched fish oils|Subjects will take a Placebo capsule for 90 days, followed by an 8 week washout period, and then will take the (EPA)-enriched omega-3 polyunsaturated fatty acids supplements as a capsule (3-4 g of EPA/day) for 90 days.
11996023|NCT00621816|Drug|nitroprusside|nitroprusside continuous infusion, dose to be titrated to clinical effect
11996024|NCT00621816|Drug|placebo infusion|blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion
11996025|NCT00621803|Drug|Probiotic Lactobacillus casei rhamnosus (Lcr35)|
11996026|NCT00621790|Drug|fenoldopam|fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
11996027|NCT00621790|Drug|placebo|placebo
11996028|NCT00621777|Drug|Varenicline|"At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
11996029|NCT00621777|Drug|Placebo|"At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
11996030|NCT00621764|Biological|Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)|≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
11996031|NCT00621764|Biological|Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)|0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
11996032|NCT00621764|Biological|Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)|≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
11996033|NCT00621764|Biological|Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)|0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
11996034|NCT00621751|Drug|Carbamazepine|800 mg daily
11996035|NCT00621751|Drug|Placebo|Placebo
11996036|NCT00621725|Drug|AZD2171|Oral dose
11996037|NCT00621712|Device|GamCath® central venous catheter|choice of catheter type
11996038|NCT00621712|Device|GamCath Dolphin® Protect central venous catheter|choice of catheter type
11996039|NCT00621699|Drug|1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
11996040|NCT00621699|Drug|1 capsule Prograf(R) (tacrolimus), Astellas Pharma GmbH, Germany|administration of 1 capsule Prograf(R) (5 mg tacrolimus), 0-144 h blood sampling
11996041|NCT00621699|Drug|1 tablet Ezetrol(R) + 1 capsules Prograf(R)|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 1 capsule Prograf(R) (5 mg Tacrolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
11996042|NCT00621686|Biological|bevacizumab|
11996043|NCT00621686|Drug|sorafenib tosylate|
11996044|NCT00621673|Drug|Kogenate (BAY 14-2222)|Antihemophilic factor (recombinant) 20-40 IU/ kg based on body weight of rFVIII, IV, 3 times a week
11996045|NCT00621660|Procedure|Acupuncture|"Acupuncture was administered bilaterally to the standard antiemetic point2-4 pericardium six (PC6) located between the tendons of palmaris longus and flexor carpii radialis at two body-inches proximal of the wrist crease. Sharp needles, diameter 0.25 x length 40 millimetres, were inserted into a depth of a half body-inch. One body-inch (or a cun in traditional Chinese medicine context) is equivalent to the greatest width of the individual patients´ thumb at the distal phalanx, approximately one and a half centimetres or one American thumb. The needles were manipulated three times (at the start, middle and end of the treatment session) by twirling, thrusting and lifting until deqi occurred."
11996046|NCT00621660|Procedure|Sham|Sham acupuncture was administered bilaterally to a non-acupuncture point two body-inches proximal of PC6 with the telescopic Park sham device16, 0.30 x 40 millimetres (fully extended length). That needle looks identical with a real needle but is blunted and glides upwards into its handle instead of penetrating, which gives an illusion of penetration. The marking tubes hold the needles in place. The therapist gave an illusion of manipulation by turning the needle three times, each time for a couple of seconds until the needle touched the skin, but no deqi occurred. Except when placing and manipulating the sham needle, it was not pressed against the skin at all.
11996047|NCT00621647|Drug|Quetiapine Fumarate|
11996048|NCT00621647|Drug|Quetiapine Fumarate|
11996049|NCT00621647|Drug|Placebo|
11996050|NCT00621634|Dietary Supplement|Omega-3 fish oil capsules (including DHA)|Fish oil capsules of 1000 mg ea., including DHA 460-540 mg/capsule 2 capsules TID daily at mealtime for 12 consecutive weeks
11996051|NCT00621634|Dietary Supplement|Placebo|Corn/Soybean (1:1) placebo 1000 mg capsules 2 capsules TID daily at mealtime for 12 consecutive weeks
11996052|NCT00621621|Device|Freezor® Cardiac Cryoablation Catheter CryoConsole System|cryoablation
11996053|NCT00621608|Procedure|Hyperbaric Oxygen Therapy|Hyperbaric Oxygen Therapy (HBOT) will be provided 5 days per week for 6 weeks for a total of 30 treatments on average. Subjects will be placed into the hyperbaric chamber for approximately 90 minutes of HBOT at 2.4 ATA (partial pressure of oxygen = 1,800 mmHg) when inside the chamber. Subjects will receive dressing changes as required per standard of care.
11996054|NCT00621608|Procedure|Placebo Hyperbaric Oxygen Chamber|Patients will receive HBOT placebo 5 days per week for 6 weeks for a total of 30 treatments. Each patient will be placed into the hyperbaric chamber and will receive 90 minutes of room air while inside the chamber and the initial flow of air into the chamber will produce a small increase in pressure (0.3 ATA partial pressure of oxygen = 210 mmHg) which will then be released over a period of 10 minutes. Subjects will receive dressings changes as required per standard of care.
11996055|NCT00621595|Dietary Supplement|USDA School Breakfast|Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat.
11996056|NCT00621569|Behavioral|Dietary Approaches to Stop Hypertension-The DASH diet|The purpose of this study is to create a culturally appropriate diet to test the effectiveness of the intervention to lower blood pressure in a grou pof African American individuals at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).
11996057|NCT00621569|Behavioral|Intervention with no dietary component - information regarding useful life skills|Participants receive information regarding useful life skills in a group setting
11996058|NCT00621556|Drug|RG1068 (Synthetic Human Secretin)|Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute
11996059|NCT00621543|Device|IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]|When a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the Food and Druga Administration (FDA) instructions.
11996060|NCT00621530|Drug|ketorolac tromethamine opthalmic solution|ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery
11996061|NCT00621530|Drug|placebo|placebo will be added to the patient's routine spinal anesthetic for surgery
11996062|NCT00621517|Drug|Bupropion|Partipants will receive 150 mg bupropion per night
11996063|NCT00621517|Drug|Placebo|1 capsule nightly for six weeks
11996064|NCT00621504|Drug|Ceftaroline fosamil for Injection|2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days
11996065|NCT00621504|Drug|IV Ceftriaxone|1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days
11996066|NCT00621504|Drug|Placebo|Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
11996067|NCT00621504|Drug|Clarithromycin|In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
11996068|NCT00621491|Drug|Warfarin|Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months
11996069|NCT00621478|Drug|lorazepam or diazepam|"Administration instructions will ask to deliver 0.04 ml per kilogram of child's weight of the study medication up to a maximum of 1.6 ml. 0.04 ml/kg (maximum dose 1.6 ml) will deliver 0.1 mg/kg of lorazepam (maximum dose 4 mg) and 0.2 mg/kg of diazepam (maximum dose 8 mg). Half of this dose can be repeated in 5 minutes if the patient is still convulsing.
~The medication will be administered as a slow IV push."
11996070|NCT00621465|Behavioral|Critical Time Intervention (CTI)|CTI is designed specifically to enhance the continuity and focus of care during the transition from psychiatric hospital to community care. CTI does not replace community treatment and support, but instead is meant to complement available services. CTI will provide training in community living skills and in team-managed transfer of caregiving from hospitals to services and supports in the community. Participants will receive CTI for 9 months after hospital discharge.
11996071|NCT00621465|Behavioral|Usual care|Usual care will include the standard aftercare and community care services.
11996072|NCT00621452|Biological|therapeutic autologous lymphocytes|Given IV
11996073|NCT00621452|Drug|cyclophosphamide|Given IV
11996074|NCT00621452|Biological|aldesleukin|Given subcutaneously
11996075|NCT00621452|Genetic|polymerase chain reaction|Correlative studies
11996076|NCT00621452|Genetic|gene rearrangement analysis|Correlative studies
11996077|NCT00621452|Procedure|lymph node biopsy|Optional correlative studies
11996078|NCT00621452|Biological|genetically engineered lymphocyte therapy|Receive genetically modified T cells
11996079|NCT00621452|Procedure|bone marrow aspiration|Optional correlative studies
11996080|NCT00621452|Other|flow cytometry|Correlative studies
11996081|NCT00621452|Other|laboratory biomarker analysis|Correlative studies
11996082|NCT00621452|Other|enzyme-linked immunosorbent assay|Correlative studies
11996083|NCT00621439|Drug|Pegylated Interfon Alpha 2B|Patients will receive PEG-IFN 6 mcg/kg subcutaneously 4 days prior to surgery. Patients will be premedicated with acetaminophen 700 mb orally prior to the injection. Only one dose of drug will be given. Enucleation will follow in 4 days.
11996084|NCT00621439|Drug|Placebo|Patients will receive placebo.
11996085|NCT00621400|Drug|Lenalidomide|5 mg/day, orally for 21 days with 7 days rest (28 day cycle) for the first cohort; or 10mg/day, orally for 21 days with 7 days rest (28 day cycle) for the second cohort, 15mg/day, orally for 21 days with 7 days rest (28 day cycle) for the third cohort or 20mg/day, orally for 21 days with 7 days rest (28 day cycle) for the last and fourth cohort
11996086|NCT00621400|Drug|Melphalan|0,18mg/Kg/day from day 1- 4
11996087|NCT00621400|Drug|Dexamethasone|40mg/day from day 1- 4.
11996088|NCT00621387|Drug|ofloxacin and roxithromycin|150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
11996089|NCT00621387|Drug|placebo|placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
11996896|NCT00616070|Other|Placebo|Vehicle
11996090|NCT00621374|Behavioral|Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)|There is also the possibility that the two treatments together may be even more helpful than either one alone. Because some of the patients in this study will get both CBT and self-hypnosis, we will be able to determine if each one facilitates the efficacy of the other. If the patients treated in this study report benefits, as we expect they will, then this will encourage us to design and complete a larger study to better understand how patients with MS would benefit from these treatments.
11996091|NCT00621374|Behavioral|Cognitive Behavioral Therapy (CBT)|"One treatment module is we will study is called cognitive restructuring or cognitive-behavior therapy (CBT). In this treatment, people learn to identify negative thoughts that make them feel bad or anxious. Such negative thoughts lead to feelings of frustration and anxiety, and can even increase the experience of pain, because they cause a person to focus more on pain. With CBT, people learn to identify and stop these thoughts, and then replace them with more reassuring ones. When they do this, they feel more relaxed and focus less on their pain. As a result, they often say that they feel much better and are less aware of pain."
11996092|NCT00621374|Behavioral|Self-Hypnosis Training (HYP)|Self-hypnosis (HYP) is another strategy that people can learn to manage pain. With this treatment, people learn to enter a state of focused attention, and then change how they experience pain. Although we do not yet know how hypnosis works, research has repeatedly shown that the effects are real; when people report decreases in pain with hypnosis, scans and images of the brain's activity show decreases in the parts of the brain that process pain information. With hypnosis, people are not just pretending to feel less pain, they actually do feel less pain.
11996093|NCT00621374|Behavioral|Education Control (CONT)|The CONT condition for this study will include lectures that are interactive and are compelling and informative enough to be both (1) credible as an attentional control condition and (2) perceived as helpful to subjects. The CONT condition will not, however, include instructions in making specific cognitive or behavioral changes related to pain management. Thus, it could control for non-specific factors related to behavioral treatment, but will not impact the primary outcome measure (pain).
11996094|NCT00621361|Drug|AZD2171|Oral
11996095|NCT00621361|Drug|Etoposide|Intravenous
11996096|NCT00621361|Drug|Cisplatin|Intravenous
11996097|NCT00621348|Drug|Isotonic fluid|0.9% saline with 5% dextrose at standard maintenance rate
11996098|NCT00621348|Drug|Hypotonic fluid|Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose
11996099|NCT00621348|Drug|Hypotonic fluid|N/5 saline in 5% dextrose at standard maintenance rate
11996100|NCT00621322|Biological|GSK Biologicals' AS01B adjuvant|Intramuscular injection, 2 doses
11996101|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1|Intramuscular injection, 2 doses
11996102|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2|Intramuscular injection, 2 doses
11996103|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3|Intramuscular injection, 2 doses
11996104|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1|Intramuscular injection, 2 doses
11996105|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2|Intramuscular injection, 2 doses
11996106|NCT00621309|Drug|Rifampicin|Rifampicin, an antibiotic used to treat TB, is administered at a dose of 300 mg day x 7 days to induce CYP3A5.
11996107|NCT00621309|Dietary Supplement|sulforaphane plus rifampicin|Sulforaphane (SFN) is an isothiocyanate derived from the plant phytochemical, glucoraphinin. It appears to inhibit ligand binding to the ligand activated nuclear transcription factor, Pregnane X-Receptor (PXR). This arm tests the hypothesis that SFN can block ligand binding to the PXR, thereby inhibiting transcriptional activation of PXR-regulated genes. Sulforaphane is administered daily for 7 days as a broccoli sprout extract, at a dose rate of 75 mg (~420 umoles)per day for 7 days. Rifampicin is also administered once per day at a dose rate of 300 mg/day for 7 days.
11996108|NCT00621309|Dietary Supplement|sulforaphane alone|Sulforaphane (SFN) is an isothiocyanate derived from the plant phytochemical, glucoraraphinin. It appears to inhibit ligand binding to the ligand activated nuclear transcription factor, Pregnane X-Receptor (PXR). This arm tests the hypothesis that SFN can block ligand binding to the PXR, thereby inhibiting transcriptional activation of PXR-regulated genes
11996109|NCT00621296|Drug|MP-424 (Telaprevir)|Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
11996110|NCT00621283|Drug|RG1068 (Synthetic Human Secretin)|Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute
11996111|NCT00621270|Drug|BCI-540|BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
11996112|NCT00621257|Dietary Supplement|ergocalciferol|8000 units/ml
11996113|NCT00621257|Dietary Supplement|Cholecalciferol|400 units per drop
11996114|NCT00621244|Drug|LBH589|
11996115|NCT00621231|Dietary Supplement|Placebo|Placebo
11996116|NCT00621231|Dietary Supplement|Protein|30 E% from protein
11996117|NCT00621218|Drug|tretinoin gel 0.05%|Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
11996118|NCT00621218|Drug|vehicle|Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.
11996119|NCT00621205|Behavioral|Weight reduction, Resistance training, Aerobic exercise training, Control|Weight reduction: 12 weeks intensive weight loss, 20 weeks maintenance Resistance and aerobic exercise training: individualized and progressive training programs
11996120|NCT00621192|Drug|meropenem|"Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant.
~20 mg/kg every 12 hours in infants <32 weeks GA and PNA < 2 weeks 20 mg/kg every 8 hours in infants <32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA < 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks"
11996121|NCT00621179|Drug|Leuprolide acetate in depot suspension|Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
11996122|NCT00621179|Other|No intervention|
11996123|NCT00621166|Drug|generic lopinavir/ritonavir|"Patients will start with lopinavir/ritonavir new formulation 400/100 mg bid with a low fat diet plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). The choice of the 2 NRTIs is at the discretion of the investigator, though in general the use of zidovudine+lamivudine (300/150mg Combivir®) is recommended. If patients can be included at or before gestational week 20, a 12h pharmacokinetic curve will be recorded at week 20 (± 2 weeks)(Group 1). There should be a minimum of 2 weeks between start of lopinavir and pharmacokinetic recording. If they are included after week 20, the first 12h pharmacokinetic curve will be recorded at gestational week 33 (± 2 weeks)(Group 2). For the patients in both groups a 12 hr curve will be recorded.
~Subjects in Group 1 will be offered to conduct a second 12h pharmacokinetic curve at week 20 (± 2 weeks), but this is only optional. Both groups will be asked to participate in the post partum curve, again this is optional."
11996124|NCT00621153|Drug|Candesartan Cilexetil|Candesartan Cilexetil 16 mg oral
11996125|NCT00621153|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 mg
11996126|NCT00621153|Drug|Candesartan Cilexetil|Candesartan Cilexetil 32 mg oral
11996127|NCT00621140|Drug|linagliptin|active
11996128|NCT00621140|Drug|placebo|placebo
11996129|NCT00621114|Device|GamCath® central venous catheter|Choice of central venous catheter type
11996130|NCT00621114|Device|GamCath Dolphin® Protect central venous catheter|Choice of central venous catheter type
11996131|NCT00621101|Drug|1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
11996132|NCT00621101|Drug|1 tablet Rapamune(R) (sirolimus), Wyeth Pharma, Germany|administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling
11996133|NCT00621101|Drug|1 tablet Ezetrol(R) + 1 tablet Rapamune(R)|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
11996134|NCT00621088|Procedure|Intertan|Operations performed either with a Sliding Hip Screw or a nail (Intertan)
11996135|NCT00621075|Other|Pulmonary Arterial Hypertension - Lung Perfusion Scans|Correlation of data from non-invasive tests such as lung perfusion scans with hemodynamic measurements
11996136|NCT00621062|Procedure|High Ligation of the GSV|Performed in local or general anesthesia in accordance to clinical praxis and the patients own preference. After high ligation the GSV is stripped from the groin to the most distant insufficient part or just under the knee joint.All proximal branches are ligated. Including the superficial epigastric vein. The stripping instrument can be inserted in either cranial or caudal direction but all veins are stripped in the cranio-caudal direction.
11996137|NCT00621062|Procedure|Endovenous Laser Ablation|Laser ablation is performed in tumescence anesthesia which is performed with a 150-200 ml (sometimes more is required, up to 400ml in patients with a poorly formed saphenous sheath) solution of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). Laser is performed under duplex guidance and the catheter is inserted percutaneously into the GSV at knee level and parked distant to the saphenofemoral junction (SFJ) just distal to the superficial epigastric vein. Laser ablation is performed down to the most distal insufficient part of GSV or just below the knee joint. We use an effect of 14 Watt administration of 70-80 J / cm at a continuous mode at a speed of 1cm/5sec.
11996138|NCT00621062|Procedure|Radiofrequency ablation|RF ablation is performed in tumescence anesthesia which is performed with a 150-200 ml solution (same as above) of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). RF is performed under duplex guidance and the Closure-FAST catheter is inserted percutaneously into the GSV at the knee level and parked distant to the SFJ just distal to the superficial epigastric vein. Probe size and length used for RF is chosen in accordance to the manufacturer's recommendation and with a probe temperature of 120 degrees C. RF closure is performed down to the most distal insufficient part of GSV or just under the knee joint.
11996139|NCT00621062|Procedure|Foam Sclerotherapy|Sclerosant foam consists of 2ml 3% aethoxysclerol mixed with 8ml air (Tessari method). A maximum of 10 ml is injected. Access to the vein for the sclerosant is gained by a duplex guided puncture or a mini incision mid-thigh or just above the knee and the amount of sclerosant foam used is 2,5-10 ml. Duplex is used prior to the operation in order to mark the vein and during the operation in order to control the extent of the sclerofoam. Duplex validates that foam is deposed to the whole length of the GSV. Blood from the veins is drained by means of elevation prior to the deposition of the sclerofoam. The leg is then bandaged with elastic bandage.
11996140|NCT00621049|Drug|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
~Docetaxel should be administered before carboplatin.
~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
~Maintenance Treatment for patients in Cohort A:
~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
11996141|NCT00621049|Drug|Docetaxel/Carboplatin|"Adjuvant Treatment Cohort B:
~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
~Docetaxel should be administered before carboplatin.
~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
11996142|NCT00621036|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
11996143|NCT00621036|Biological|sargramostim|
11996144|NCT00621036|Drug|methotrexate|
11996145|NCT00621036|Drug|thiotepa|
11996146|NCT00621036|Radiation|radiation therapy|
11996147|NCT00621023|Drug|Decitabine, Arsenic Trioxide and Ascorbic Acid|Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles.
11996185|NCT00620815|Biological|MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine|Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
11996186|NCT00620802|Drug|CGT-2168|(CGT-2168, one capsule each daily)
11996148|NCT00621010|Drug|CTS21166 (ZPQ-21166)|"Cohort 1: (7.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 2: (22.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 3: (45 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 4: (90 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 5: (150 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 6: (225 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days,proceed to Part B.
~Cohort 7: (225 mg): Up to 10 subjects, open label, 3 hour infusion"
11996149|NCT00620997|Drug|Proparacaine drops 0.05%|topical, 0.05% drops, PRN continuously for up to 7 days
11996150|NCT00620997|Drug|saline drops|saline drops continuously PRN for up to 7 days
11996151|NCT00620971|Drug|Vinorelbine|Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
11996152|NCT00620971|Drug|Cisplatin|Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
11996153|NCT00620971|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
11996154|NCT00620971|Drug|Docetaxel|Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
11996155|NCT00620971|Drug|Gemcitabine|Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
11996156|NCT00620971|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
11996157|NCT00620971|Drug|Docetaxel|Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
11996158|NCT00620971|Drug|Cisplatin|Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
11996159|NCT00620971|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
11996160|NCT00620958|Behavioral|Individual cognitive behavioral therapy (ICBT)|ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
11996161|NCT00620958|Behavioral|Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)|Parent relationship training will teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
11996162|NCT00620958|Behavioral|Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)|Parent reinforcement training will teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
11996163|NCT00620945|Drug|Phenoxybenzamine|"Use of Phenoxybenzamine:
~Loading dose given at the time of going on CPB:
~For patients with obstructing lesions on systemic side:
~0.25 mg/kg dose in the bypass circuit
~None intravenous
~For patients without obstructing left sided lesions:
~0.5 mg/kg in the bypass circuit
~0.5 mg/kg I.V. at cannulation
~Maintenance dose given in the post-operative period:
~0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours
~0.3 mg/kg P.O. every 8 hours for next 24 hours
~0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop
~Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group"
11996164|NCT00620932|Behavioral|Exercise|Patients will be randomly assigned to groups and will either be given an exercise program individually tailored to them for them to participate in for 6 months or else be wait-listed for 6 months and remain on whatever exercise regimen they were already on.
11996165|NCT00620919|Drug|RG1068 (Synthetic Human Secretin)|Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute
11996166|NCT00620906|Procedure|Manipulation|HVLA manipulation to Sacroiliac Joint
11996167|NCT00620893|Drug|PEG- 400 based artificial tear|Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily
11996168|NCT00620893|Drug|Systane|Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily
11996169|NCT00620880|Behavioral|Blood sample|
11996170|NCT00620867|Drug|Ibuprofen|800 mg oral tablet three time daily with meals for 6 weeks
11996171|NCT00620867|Drug|celecoxib|200 mg oral capsule once daily with morning meal for 6 weeks
11996172|NCT00620867|Other|placebo|matched placebo orally for 6 weeks
11996173|NCT00620854|Drug|Recombinant Salmon Calcitonin (rsCT)|Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
11996174|NCT00620854|Drug|Oral Tablet|0.15 mgs recombinant salmon calcitonin, single oral dose
11996175|NCT00620854|Drug|Oral Tablet|0.2mgs recombinant salmon calcitonin, single oral tablet
11996176|NCT00620854|Drug|Nasal Spray|200 IU recombinant salmon calcitonin, single intranasal spray
11996177|NCT00620841|Other|genotyping|Restriction fragment lenght polymorphisms
11996178|NCT00620828|Other|Placebo saline injection|20 cc of sterile, injectable saline
11996179|NCT00620828|Drug|Ropivicaine 0.5%|Ropivicaine
11996180|NCT00620815|Biological|MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine|Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.
11996181|NCT00620815|Biological|Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1|Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.
11996182|NCT00620815|Biological|Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine|Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.
11996183|NCT00620815|Biological|Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1|Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.
11996184|NCT00620815|Biological|Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine|Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
11996187|NCT00620802|Drug|Plavix|(clopidogrel, 75 mg)
11996188|NCT00620789|Drug|Escitalopram + CBT-I|"Escitalopram, 10 mg daily for the duration of the study (6 months)
~CBT-I, four biweekly sessions during eight week Treatment phase."
11996189|NCT00620789|Behavioral|CBT-I plus placebo antidepressant medication|"CBT-I, 4 biweekly sessions, eight week Treatment phase.
~Placebo,daily for duration of study(6 months)."
11996190|NCT00620789|Drug|Escitalopram|"Escitalopram, 10 mg daily for the duration of the study (6 months)
~SH, four biweekly sessions during eight week Treatment phase"
11996191|NCT00620776|Behavioral|Cognitive Behavioral Therapy|This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding. They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues. This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks.
11996192|NCT00620776|Drug|Venlafaxine XR|Venlafaxine XR, 75-225 mg/d, oral administration. 14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).
11996193|NCT00620763|Other|High Meat - High Potential Renal Acid Load (PRAL) diet|Menu high in meat protein
11996194|NCT00620763|Other|Low Protein - Low Potential Renal Acid Load (PRAL) diet|Menu low in meat protein
11996195|NCT00620750|Drug|Extended release injectable naltrexone (Vivitrol)|Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.
11996196|NCT00620737|Biological|Autologous Human Fibroblasts (Isolagen TherapyTM)|"Collection of skin biopsy.
~Administration of 2 study injections
~Performance of various study assessments during clinic visits"
11996197|NCT00620737|Biological|Placebo|"Collection of skin biopsy.
~Administration of 2 study injections
~Performance of various study assessments during clinic visits"
11996198|NCT00620724|Drug|Placebo|Placebo three times daily
11996199|NCT00620724|Drug|Nifedipine|20 mg of slow-release Nifedipine three times daily
11996200|NCT00620711|Device|Olympic Cool Cap|Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
11996201|NCT00620685|Drug|Placebo|Tablet, once daily for 4 weeks
11996202|NCT00620685|Drug|PH-797804|Tablet, 1 mg PH-797804, once daily for 4 weeks
11996203|NCT00620685|Drug|PH-797804|Tablet, 5 mg PH-797804, once daily for 4 weeks
11996204|NCT00620672|Dietary Supplement|omega 3 fatty acids|The supplements are taken orally with a meal, each day. The amount of the omega 3 fatty acid docosahexaenoic acid is 400 mg/day; taken in two 500 mg capsules each providing 200 mg docosahexaenoic acid. The placebo is two 500 mg capsules soybean/canola oil. Both the supplement and placebo are a total of 1 gm/day (2x500 mg) and about 10 calories per day.
11996205|NCT00620672|Dietary Supplement|vegetable oil|The supplement is a dietary supplement of vegetable oil as a placebo
11996206|NCT00620659|Drug|Comparator: MK0249|Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd).
11996207|NCT00620659|Drug|Comparator: placebo|Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
11996208|NCT00620659|Drug|Comparator: modafinil|Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
11996209|NCT00620646|Drug|aspirin, clopidogrel|aspirin 100 mg plus clopidogrel 150mg qd
11996210|NCT00620646|Drug|aspirin, clopidogrel, cilostazol|aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid
11996211|NCT00620633|Biological|WT1-sensitized T cells|Eligible patients who consent to enter this trial and for whom WT1 sensitized T cells have been generated in vitro, will receive a single dose of allogeneic WT1-sensitized T cells by bolus intravenous infusion. In this phase I trial, 6 dose levels of T cells will be evaluated, in sequential groups of 3 patients. Dose Escalation will be based on the incidence and severity of toxicities.
11996212|NCT00620620|Drug|Inhaled placebo|Inhaled Staccato Placebo
11996213|NCT00620620|Drug|Inhaled Zaleplon 0.5 mg|Inhaled Staccato Zaleplon 0.5 mg
11996214|NCT00620620|Drug|Inhaled Zaleplon 1 mg|Inhaled Staccato Zaleplon 1 mg
11996215|NCT00620620|Drug|Inhaled Zaleplon 2 mg|Inhaled Staccato Zaleplon 2 mg
11996216|NCT00620620|Drug|Inhaled Zaleplon 4 mg|Inhaled Staccato Zaleplon 4 mg
11996217|NCT00620607|Drug|huC242-DM4|dose of 126 mg/m2 or 168 mg/m2 given as IV once every 3 weeks
11996218|NCT00620594|Drug|BEZ235|
11996219|NCT00620581|Drug|Paroxetine|Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle
11996220|NCT00620568|Drug|SLV-313 SR|sustained release tablets taken once daily for 14 days
11996221|NCT00620555|Drug|gabapentin|Orally administered gabapentin
11996222|NCT00620542|Drug|Rosuvastatin|capsule, oral, once daily
11996223|NCT00620542|Drug|Atorvastatin|capsule, oral, one daily
11996224|NCT00620529|Dietary Supplement|Ocean Nutrition 2050|1000mg capsules, 4 capsules/day for 8 weeks
11996225|NCT00620529|Dietary Supplement|Olive oil capsules|Olive oil capsules, 4 per day for 8 weeks
11996226|NCT00620503|Drug|Proellex 25 mg formulation A|One Proellex 25 mg formulation A capsule
11996227|NCT00620503|Drug|Proellex 25 mg formulation B|One 25 mg Proellex capsule formulation B administered both fed and fasted
11996228|NCT00620490|Drug|ropivacaine|Ropivacaine 0.5% 0.1 ml/kg per hour
11996229|NCT00620490|Other|nacl 0,9%|saline 0.9% 0.1 ml/kg per hour
11996230|NCT00620477|Drug|injection in the knee joint with 20 ml of chirocaine 0.125%|injection in the knee joint with 20 ml of chirocaine 0.125%
11996231|NCT00620477|Drug|injection in the knee joint with 20 ml of physiological fluid|injection in the knee joint with 20 ml of physiological fluid
11996232|NCT00620464|Drug|Radiopaque Implanon|Radiopaque rod for 3 years
11996233|NCT00620464|Drug|Implanon (etonogestrel implant)|Implanon (etonogestrel implant) for 3 years
11996234|NCT00620451|Drug|larazotide acetate|gelatin capsule
11996236|NCT00620438|Drug|Lumefantrine-artemether and nevirapine|Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to HIV positive patients receiving nevirapine 200mg twice daily as part of their antiretroviral treatment
11996237|NCT00620438|Drug|lumefantrine-artemether and efavirenz|Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to HIV positive adults receiving efavirenz tablets 600mg once daily
11996238|NCT00620438|Drug|Lumefantrine-artemether and rifampicin|Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to patients receiving rifampicin as part of fixed dose combination therapy for tuberculosis
11996239|NCT00620425|Drug|Sumatriptan|injection
11996240|NCT00620412|Dietary Supplement|Lactobacillus rhamnosus|2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10^10 LGG organisms.
11996241|NCT00620412|Dietary Supplement|placebo control|2 capsules by mouth twice a day for 28 days
11996242|NCT00620412|Biological|Influenza Virus Vaccine Live, Intranasal|intranasal spray, 0.1ml per nostril, one time dose
11996243|NCT00620399|Other|lumbar corset|
11996244|NCT00620386|Device|Bonfils|Endotracheal intubation using Bonfils Intubating Fiberscope
11996245|NCT00620386|Device|Macintosh|Endotracheal intubation using Macintosh laryngoscopy
11996246|NCT00620373|Device|Molecular Breast Imaging|Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
11996247|NCT00620373|Device|Conventional Mammography|Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
11996248|NCT00620373|Drug|Technetium (99mTc) sestamibi|Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
11996249|NCT00620360|Dietary Supplement|fructose|acute administration of 4 times 0.3g fructose/kg lean body mass
11996250|NCT00620360|Dietary Supplement|Fructose|acute administration of 4 times 0.3 g/kg fat-free mass oral fructose
11996251|NCT00620347|Drug|sunitinib|sunitinib (50mg/day, 4weeks on, 2 weeks off) Repeat every 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, or patients' refusal.
11996252|NCT00620321|Drug|LY2181308 sodium|750 milligrams (mg) is administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 (28 days) and Days 1, 8, 15, 22 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.
11996253|NCT00620321|Drug|cytarabine|1.5 grams per square meter (g/m²) will be administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.
11996254|NCT00620321|Drug|idarubicin|12 milligrams per square meter (mg/m²) will be administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and on Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.
11996255|NCT00620308|Drug|CD-NP|One of two dosage levels (20 ng/kg/min and another level to be finalized) as a continuous intravenous infusion for four hours
11996256|NCT00620308|Drug|Placebo|Dextrose 5% in water (the vehicle)
11996257|NCT00620295|Drug|bortezomib|Bortezomib will be given 1 hour after gemcitabine by intravenous pyelogram (IVP) over 3 to 5 seconds followed by a standard saline flush or through a running intravenous (IV) line at the patient's assigned dose (1.0 up to 1.8 mg/m^2) on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.
11996258|NCT00620295|Drug|gemcitabine hydrochloride|Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose (800 up to 1000 mg/m^2) on day 1 and day 8 of a 21 day cycle.
11996259|NCT00620282|Drug|liraglutide|Stepwise dose increase, s.c. (under the skin) injection, once daily
11996260|NCT00620282|Drug|placebo|Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily
11996261|NCT00620282|Drug|glimepiride|Tablets, 1 - 4 mg daily
11996262|NCT00620269|Drug|Erlotinib|Erlotinib 150 mg p.o. daily x21 days every 3 weeks
11996263|NCT00620269|Drug|Induction or consolidation IP chemotherapy|Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles
11996264|NCT00620269|Drug|CCRT with IP chemotherapy (Irinotecan + Cisplatin)|Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 & 8 every 3 weeks X 2 cycles
11996265|NCT00620269|Radiation|CCRT|CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)
11996266|NCT00620256|Drug|AL-37807 ophthalmic suspension, 0.1%|
11996267|NCT00620256|Drug|Timolol gel forming solution, 0.5%|
11996268|NCT00620256|Other|AL-37807 ophthalmic solution vehicle|
11996269|NCT00620256|Drug|Latanoprost ophthalmic solution|
11996270|NCT00620243|Procedure|1: FDG PET|The study will evaluate the potential of PET imaging to identify early responders to chemotherapy. Patients entered into this study will undergo FDG PET within 2 weeks prior to chemotherapy and prior to initiation of the second course of chemotherapy. All images will be carried out in the same manner with respect to equipment, acquisition parameters, and time post injection, to ensure that changes in standard uptake value(SUV) correlate with metabolic changes. This will be correlated with response determined by changes in serum CA 125 levels.
11996271|NCT00620230|Drug|NVP-VAK694|
11996272|NCT00620230|Drug|NVP-VAK694|
11996273|NCT00620217|Genetic|intramyocardial injection of VEGF-A165/bFGF:placebo plasmid|The plasmid will be given at a total dose of 0.5 mg, 10 injections of 0,2 ml each into the region of reversible ischemia. The process of injecting the solution into each of ten points within the ischemic zone will take 20 to 40 seconds to minimize muscle disruption
11996274|NCT00620204|Drug|atorvastatin|atorvastatin 40mg qd for 1 year
11996275|NCT00620191|Drug|Metformin|Metformin 1000 mg twice a day titrated from 500 mg once a day
11996276|NCT00620191|Drug|Placebo|Placebo identical to metformin 2 tablets twice a day titrated from one table once a day
11996277|NCT00620178|Drug|Candesartan Cilexetil|oral once daily dose
11996278|NCT00620178|Drug|Losartan|once daily oral dose
11996365|NCT00619632|Behavioral|LC+ Provider Prompt|Participants in this group receive both the LC and Provider Prompt interventions.
11996279|NCT00620165|Drug|levetiracetam|Subjects will receive levetiracetam titrated up over 6 weeks to a maximum dose of 3000 milligrams (mg) per day, and then continue at 1500 mg twice daily for an additional 6 weeks.
11996280|NCT00620165|Drug|placebo|Subjects will receive identical placebo titrated up over 6 weeks to a maximum daily dose, and then continue twice daily for an additional 6 weeks.
11996281|NCT00620152|Behavioral|1|Low glycemic load diet by telephone counseling
11996282|NCT00620152|Behavioral|2|Low fat diet by telephone counseling
11996283|NCT00620139|Biological|the arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis,|patient will undergo transoral pretreatment biopsy of the tumor. A comparable second tumor biopsy will be performed in the office after exactly 5 days of concurrent CRT (5 daily fractions of 180-200 cGy radiotherapy and a single cycle of Cisplatin or Carboplatin/5-FU based chemotherapy).Blood plasma and single-void urine specimens will be collected contemporaneously,before and after 5 days of concurrent CRT.
11996284|NCT00620126|Other|UC Home Automated Telemanagement|Weekly assessment with UC Home Automated Telemanagement
11996285|NCT00620126|Other|Best Available Care|Routine follow up visits and as needed telephone calls and clinic visits, written action plans, educational fact sheets from the CCFA
11996286|NCT00620113|Drug|Odanacatib|Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
11996287|NCT00620113|Dietary Supplement|Vitamin D3|Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
11996288|NCT00620113|Dietary Supplement|Calcium carbonate|Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
11996289|NCT00620113|Drug|Placebo|Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.
11996290|NCT00620100|Drug|Docetaxel|
11996291|NCT00620087|Procedure|Molecular Breast Imaging|Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
11996292|NCT00620087|Procedure|Screening Mammography|A screening mammogram is used to look for signs of breast cancer in women who don't have any breast symptoms or problems. X-ray pictures of each breast are taken from 2 different angles.
11996293|NCT00620074|Drug|voriconazole|Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).
11996294|NCT00620074|Drug|anidulafungin|Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy
11996295|NCT00620061|Drug|Lubiprostone 24|24 mcg capsules for oral administration
11996296|NCT00620048|Biological|Intramyocardial injection of autologous CD34-positive cells (stem cells)|Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.
11996297|NCT00620035|Drug|Radiopaque Etonogestrel Implant|One implant inserted for a 3-year treatment period
11996298|NCT00620022|Drug|Indacaterol 300 μg|Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
11996299|NCT00620022|Drug|Placebo|Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
11996300|NCT00620009|Behavioral|Empathy Feedback|Discussion of empathy ratings between patients and therapists during psychotherapy sessions.
11996301|NCT00619996|Drug|Sorafenib (Nexavar)|"Sorafenib 400 mg bid orally continuously
~Sorafenib will be administered from the start of treatment in combination with Docetaxel until progression of disease."
11996302|NCT00619996|Drug|Docetaxel|Docetaxel 75 mg/mq ev g1 every 21 days. Docetaxel will be administered for a maximum of 9 cycles.
11996303|NCT00619983|Drug|donepezil|Group 1: Will receive donepezil 5mg once a day
11996304|NCT00619983|Drug|duloxetine|Group 2: Will receive duloxetine 30 mg twice a day
11996305|NCT00619983|Drug|donepezil 2.5 mg and duloxetine 30mg|Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg
11996306|NCT00619983|Drug|placebo|Group 4: Will receive placebo pills
11996307|NCT00619983|Drug|gabapentin|Week 8: all subjects will have open label gabapentin added to their randomized study medication
11996308|NCT00619970|Procedure|Lactulose Breath Test|Healthy controls will receive one lactulose breath test to assess for SIBO
11996309|NCT00619970|Drug|xifaxan|xifaxan 550mg TID x10days
11996310|NCT00619970|Drug|placebo|placebo TID x 10days
11996311|NCT00619970|Procedure|Lactulose Breath Test|Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo
11996312|NCT00619957|Drug|Placebo tablet|one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
11996313|NCT00619957|Drug|Risedronate|one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
11996314|NCT00619944|Drug|Lumefantrine - lopinavir/ritonavir drug interaction|Lumefantrine 480 mg co-formulated with artemether 80 mg administered as single dose to HIV-positive adults receiving lopinavir/ritonavir 400 mg/100 mg twice daily
11996315|NCT00619944|Drug|Lumefantrine only arm|Lumefantrine 480 mg co-formulated with artemether 80 mg administered as a single dose to antiretroviral naive HIV-positive patients
11996316|NCT00619931|Drug|APD791|APD791 or matching placebo in escalating doses
11996317|NCT00619918|Drug|Nebulized 3% saline|4 ml inhaled q8h
11996318|NCT00619918|Drug|Placebo|normal saline
11996319|NCT00619905|Drug|ACZ885|
11996320|NCT00619905|Drug|ACZ885|
11996321|NCT00619892|Drug|quetiapine XR|Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
11996322|NCT00619892|Drug|placebo|Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
11996366|NCT00619619|Drug|Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)|DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.
11996969|NCT00615433|Drug|Placebo comparator|Placebor Comparator
11996323|NCT00619879|Drug|Myeloablative Chemotherapy Regimen for Lymphoid Malignancies or Cord Blood Unit Recipients|"Total Body Irradiation (TBI) 1200 cGy will be given on days -8,-7,-6 and -5 in eight sessions, delivering 150cGy in each session.
~Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4.
~Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3, -2."
11996324|NCT00619879|Drug|Myeloablative Chemotherapy Regimen for Non-Cord Blood Unit Recipients with Myeloid Malignancies|"Busulfan administration:
~For children >/= 4 years of age, Busulfan 0.8 mg/kg/dose will be given every 6 hours over days -8,-7, -6, and -5 for a total of 16 doses.
~For children < 4 years of age, Busulfan 1 mg/kg/dose will be given every 6 hours over days -8, -7, -6, -5 for a total of 16 doses.
~Pharmacokinetic analysis will guide dose modifications targeted to receive an average AUC of 800-1200 microMols*min for the 16 doses.
~Lorazepam (0.05 mg/kg) IV will be administered one half hour before the initial dose of Busulfan is given and every 6 hours through day -4.
~Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4.
~Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3 and -2."
11996325|NCT00619879|Other|Hematopoietic Progenitor Cell Transplantation (HPCT)|Hematopoietic progenitor cells (HPCs) will be infused on day 0. Source of cells may be bone marrow, peripheral blood cells, or cord blood units, from matched related or unrelated donors.
11996326|NCT00619879|Radiation|CNS radiation treatment for ALL with prior CNS disease patients|"Patients with prior CNS disease over the age of 1 year will be treated with 600 cGy of cranial irradiation in addition to 1200 cGy of TBI.
~Patients diagnosed with ALL with CNS disease (at the time of diagnosis or relapse) < 1 year of age will receive CNS treatment as Intrathecal Methotrexate as follows:
~Infants ≤ 1 year of age at the time of Intrathecal Therapy will receive a dosing of 7.5 mg once a month for 6 months after transplant beginning at day +30 with an adequate white count
~Children 1-2 years of age at the time of Intrathecal Therapy will receive 8 mg once a month for 6 months after transplant beginning at day +30 with an adequate white count"
11996327|NCT00619866|Drug|Elagolix|Elagolix tablets administered orally
11996328|NCT00619866|Drug|placebo|Placebo tablet administered orally
11996329|NCT00619853|Behavioral|treatment approach - CIMT|CIMT, 2 months, 2Hr per day
11996330|NCT00619853|Behavioral|treatment approach - HABIT|HABIT-2 months, 2Hr per day
11996331|NCT00619840|Drug|methylphenidate hydrochloride|sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
11996332|NCT00619840|Drug|Placebo|10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
11996333|NCT00619827|Drug|300 IR grass pollen allergen extract tablet|300 IR grass pollen allergen extract tablet once daily during four months
11996334|NCT00619827|Drug|Placebo tablet|Placebo tablet once daily during four months
11996335|NCT00619814|Procedure|Double-contrast Barium enema, colonoscopy|This is a blinded cohort study comparing double contrast barium enema (DCBE) and colonoscopy in detecting polyps and/or cancer in patients with positive FOBT. Initial evaluation consisted of complete clinical history and physical examination. A DCBE and a colonoscopy were performed in all patients. All polyps identified during colonoscopy were removed and classified by histology. Sensitivity and specificity of DCBE for polyp and/or cancer detection was determined. Tolerability and grade of satisfaction with study procedures was assessed.
11996336|NCT00619801|Drug|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
11996337|NCT00619801|Drug|Placebo|Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
11996338|NCT00619788|Device|4.0-5.0mm AngioSculpt Scoring Balloon Catheter|The AngioSculpt Scoring Balloon Catheter is a line of innovative angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands.
11996339|NCT00619775|Device|PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device|Carotid artery stenting with distal embolic protection.
11996340|NCT00619762|Device|LTM - a porcine-based surgical mesh|Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy
11996341|NCT00619749|Dietary Supplement|juice rich in polyphenols|juice during 2 weeks
11996342|NCT00619749|Dietary Supplement|juice poor in polyphenols|juice during 2 weeks
11996343|NCT00619736|Drug|NSA-789|
11996344|NCT00619736|Other|Placebo|
11996345|NCT00619723|Drug|Citicoline|Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.
11996346|NCT00619723|Drug|Placebo|Inactive ingredient matching the active medication in appearance.
11996347|NCT00619723|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT.
11996348|NCT00619710|Drug|Meropenem|Intravenous
11996349|NCT00619710|Drug|Imipenem-cilastatin|Intravenous
11996350|NCT00619697|Drug|biphasic insulin aspart|
11996351|NCT00619697|Drug|insulin glargine|
11996352|NCT00619697|Drug|metformin|
11996353|NCT00619697|Drug|glimepiride|
11996354|NCT00619684|Drug|lenalidomide|Given PO
11996355|NCT00619671|Drug|Rituximab (Rituxan)|Four weekly IV infusions of Rituxan with dosage individually calculated per subject.
11996356|NCT00619658|Other|telephone follow-up|subjects undergoing medical abortion will recieve a telephone call and be asked a series of clinical questions. Expulsion of the pregnancy will be assessed based on the answers to those questions.
11996357|NCT00619645|Drug|busulfan|
11996358|NCT00619645|Drug|cyclosporine|
11996359|NCT00619645|Drug|fludarabine phosphate|
11996360|NCT00619645|Drug|mycophenolate mofetil|
11996361|NCT00619645|Procedure|allogeneic hematopoietic stem cell transplantation|
11996362|NCT00619645|Procedure|peripheral blood stem cell transplantation|
11996363|NCT00619632|Behavioral|Lactation Consultant|Lactation consultant- primary care based, meets with women pre-natally, in the hospital, and at home up to 6 months post-partum.
11996364|NCT00619632|Behavioral|Provider Prompt|Prompt in electronic prenatal record will appear 5 times throughout pregnancy re: up to 10 open-ended discussion points for provider to raise
11996367|NCT00619606|Device|TwinGuard|A system consisting of an endoscopic bite block that fits together with a nasal cannula. After gastroscopy, the bite block is discarded leaving the patient receiving oxygen in recovery.An optional carbon dioxide sampling device fits with the TwinGuard in endoscopy to monitor expired air.
11996368|NCT00619606|Device|Standard endoscopic bite block|Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth
11996369|NCT00619606|Device|Standard nasal cannula|Delivers oxygen to the nose. Tubing runs from the nose around the back of the ears and under the chin which then runs to an oxygen source.
11996370|NCT00619606|Device|CO2 sample line|Samples expired air from a patients nose. Tubing is connected to a capnograph.
11996371|NCT00619593|Other|Intensified diagnostic and treatment measures following 1st appropriate ICD therapy|"Assessment of general health status (weight, BP, NYHA)
~Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15)
~Echocardiography (LVEF, LVEDD, mitral regurgitation)
~Non-invasive ischemia evaluation
~Coronary angiography (if indicated by ischemia evaluation)
~Upgrade to CRT, if indicated
~Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry)
~24 hrs ECG Holter (Heart rate variability)
~Further treatment (if applicable)
~Changes in ICD settings, or medication"
11996372|NCT00619593|Other|Standard follow-up|Standard follow-up in patients without appropriate ICD therapy
11996373|NCT00619567|Behavioral|Smartbrain|The initial session will be set for 10 minutes, with weekly increases (of 10 minutes) to a maximum of 30 minutes per day, 7 days a week. Each subject will be trained using the same modules of the Smartbrain protocol, with an emphasis on speed of information processing.
11996374|NCT00619541|Drug|Infusional 5-Fluorouracil|5-FU 3000 mg/sqm 48 hours continuous infusion every 14 days. 5-FU will be administered for a maximum of 12 cycles.
11996375|NCT00619541|Drug|Sorafenib (Bay 43-9006)|Sorafenib 400 mg bid orally continuously. Sorafenib will be administered from the start of treatment in combination with 5-FU until progression of disease.
11996376|NCT00619528|Biological|Infusion of Donor Hematopoietic Stem Cells and Campath-1H|Intervention: a four-dose (peri-operative and 3, 6, and 9-month boost) DHSC infusion protocol using two-dose Campath-1H induction combined with transient (conditioning) Tacrolimus/Sirolimus and MMF therapy will result in a high degree of macro-chimerism (>10%), and a robust prolonged donor-specific (post-thymic) immunoregulatory condition that will allow renal transplant survival in the absence of permanent immunosuppression.
11996377|NCT00619515|Other|questionnaire administration|Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).
11996378|NCT00619515|Procedure|implanted fiducial-based imaging|Undergo fiducial placement imaging
11996379|NCT00619515|Radiation|stereotactic radiosurgery|Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
11996380|NCT00619502|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, intramuscular (IM)
11996381|NCT00619489|Drug|vedolizumab|Vedolizumab for intravenous (IV) infusion
11996382|NCT00619476|Drug|GEn 1200mg/day|gabapentin enacarbil 1200mg/day
11996383|NCT00619476|Drug|GEn 2400mg/day|gabapentin enacarbil 2400mg/day
11996384|NCT00619476|Drug|GEn 3600mg/day|gabapentin enacarbil 3600mg/day
11996385|NCT00619476|Drug|Placebo|placebo
11996386|NCT00619463|Behavioral|Exercise|Eight weeks in an aerobic exercise program- 50 minutes of aerobic exercise on a treadmill - 3 days a week for 8 -16 weeks.
11996387|NCT00619463|Behavioral|Exercise|Aerobic exercise program - 55 min aerobic exercise on the treadmill 3 days a week for either 8 or 16 weeks
11996388|NCT00619450|Other|3D C-arm CT scan|The patient will be given an intravenous contrast dye and then hold their breath for 15 seconds while pictures are taken. The equipment used to take the pictures is like an arch that will rotate around the body. As the arch rotates, it will collect the pictures of the heart. These pictures will then be used to compute a three-dimensional image of the heart. The physicians will then continue with the planned procedure. The three-dimensional images will be reconstructed and available for the doctor to view during the case. The images will also be examined after the procedure by the physician.
11996389|NCT00619424|Drug|pazopanib|Oral tablet administered daily in dosages of 400 - 800 mg.
11996390|NCT00619424|Drug|erlotinib|oral tablet taken daily in dosages of 100-150 mg.
11996391|NCT00619424|Drug|pemetrexed|IV chemotherapeutic agent administered every 21 days in dosages of 400-500 mg/m2
11996392|NCT00619411|Behavioral|Interpersonal Therapy for Depressed Adolescents & Parents|15 weekly psychotherapy sessions
11996393|NCT00619398|Drug|Prograf|Oral
11996394|NCT00619398|Drug|FK506MR capsule|Oral
11996395|NCT00619385|Drug|Proellex|Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days
11996396|NCT00619372|Drug|OKT3|0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
11996397|NCT00619372|Drug|OKT3, GC|0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
11996398|NCT00619372|Drug|OKT3|1 mg OKT3, PO (in the mouth) on day 1 through 5
11996399|NCT00619372|Drug|OKT3, GC|1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
11996400|NCT00619372|Drug|OKT3|5 mg OKT3, PO (in the mouth) on day 1 through 5
11996401|NCT00619372|Drug|GC|7.5 mg GC, PO (in the mouth) on day 1 through 5
11996402|NCT00619359|Drug|Comparator: fosaprepitant dimeglumine|single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.
11996403|NCT00619359|Drug|Comparator: Aprepitant|Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).
11996404|NCT00619359|Drug|Dexamethasone|Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.
11996405|NCT00619359|Drug|Dexamethasone|Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.
11996406|NCT00619359|Drug|Ondansetron|single IV dose of 32 mg of ondansetron on Day 1.
11996407|NCT00619346|Drug|Placebo|Placebo tablets, BID X 14 days
11996408|NCT00619346|Drug|pafuramidine maleate|Pafuramidine maleate, 100 mg tablet BID X 14 days
11996409|NCT00619333|Drug|follitropin and lutropin|follitropin and lutropin
11996452|NCT00619021|Drug|gemcitabine hydrochloride|4 dose levels designated by cohort; 600 mg/m^2, 800 mg/m^2, 1000 mg/m^2, 1200 mg/m^2
11996453|NCT00619008|Other|Ad libitum low carbohydrate diet|6 week ad libitum low carbohydrate diet
11996410|NCT00619320|Behavioral|Safer Sex Skills Building (SSB)|Test the effectiveness of an intervention for reducing sexual risk factors for HIV infection in two samples of pregnant drug-using women. The intervention, Safer Sex Skills Building (SSB)(El Bassel and Schilling (1991, 1992)), is a manual-driven, gender-specific group intervention delivered by mental health counselors. To date, its effectiveness has not been examined in pregnant, drug using women. The proposed study will examine the effectiveness of the intervention in both drug treatment (RBHA, N = 200) and prenatal care (PCC, N = 200) settings. Using a randomized clinical trial design, the study will compare the five-session SSB group intervention to a one-session standard group HIV Education session (ED). Study hypotheses: that women in the SSB intervention will have better outcomes (e.g., fewer unprotected penetrative sexual behaviors) than women in the control group (ED).
11996411|NCT00619307|Drug|Rebif New Formulation + prophylactic Ibuprofen|Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected
11996412|NCT00619307|Drug|Rebif New Formulation + ibuprofen PRN|Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.
11996413|NCT00619268|Drug|Temsirolimus|25 mg once per week administered intravenously
11996414|NCT00619268|Drug|Bevacizumab|10 mg/kg * 1 time /2 weeks administered intravenously
11996415|NCT00619268|Drug|Sunitinib|50 mg administered orally once daily in 6 weeks cycles :4 weeks of treatment followed by 2 weeks off
11996416|NCT00619268|Drug|Interferon alpha-2a|Administered subcutaneously as 9 MU three times per week
11996417|NCT00619255|Behavioral|Adolescent Trauma Support Program|The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
11996418|NCT00619242|Drug|sorafenib|2 tablets with water by mouth twice a day for two weeks.
11996419|NCT00619229|Drug|Alprostadil (prostaglandin E1)|Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.
11996420|NCT00619229|Other|Placebo|Placebo/d i.v. for 15 days
11996421|NCT00619216|Drug|Mycophenolic Acid (Myfortic)|Equimolar conversion from mycophenolate mofetil to mycophenolic acid
11996422|NCT00619203|Drug|Glycerol and paracetamol|"glycerol by mouth (po) 1.5ml/kg max 25 ml/dose x 6 hourly x 8 doses
~paracetamol PR 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7"
11996423|NCT00619203|Drug|Paracetamol|paracetamol 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses
11996424|NCT00619203|Drug|Paracetamol|paracetamol po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository
11996425|NCT00619203|Drug|Paracetamol|po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository
11996426|NCT00619203|Drug|Placebo|2 placebos, one po, one suppository
11996427|NCT00619203|Drug|Paracetamol and glycerol|"35 mg/kg po first dose, then 20 mg/kg 6 hourly x 7 paracetamol
~1.5 ml/kg max 25 ml/dose 6 hourly x 8 doses"
11996428|NCT00619203|Drug|Glycerol|glycerol 1.5 ml/kg /dose 6 hourly x 8 max dose = 25ml
11996429|NCT00619190|Drug|aripiprazole|aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months
11996430|NCT00619164|Drug|E5555|E5555, 50 mg (tablet), taken orally, once a day.
11996431|NCT00619164|Drug|E5555|E5555, 100 mg (tablet), taken orally, once a day.
11996432|NCT00619164|Drug|E5555|E5555, 200 mg (tablet), taken orally, once a day.
11996433|NCT00619164|Drug|Placebo|Placebo tablet taken orally, once a day.
11996434|NCT00619151|Device|Top Hat|Implant of CarboMedics Top Hat mechanical valve.
11996435|NCT00619151|Device|Regent|Implant of the St. Jude Medical Regent mechanical valve
11996436|NCT00619138|Behavioral|individual cognitive-behavioural therapy|1 session per week for 12 weeks
11996437|NCT00619138|Behavioral|stepped care model|three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy
11996438|NCT00619125|Other|palm pilot recording responses to questionnaires|Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.
11996439|NCT00619112|Drug|temozolomide|single arm study
11996440|NCT00619099|Drug|decitabine|Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
11996441|NCT00619099|Drug|decitabine|Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
11996442|NCT00619086|Drug|Dexamethason Helvepharm ®|8 mg Dexamethason i.v. 45 minutes prior to surgery
11996443|NCT00619086|Drug|Placebo|100 ml sodium chloride i.v. 45 minutes prior to surgery
11996444|NCT00619073|Drug|clopidogrel + aspirin|Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days.
11996445|NCT00619073|Drug|placebo|Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days.
11996446|NCT00619073|Drug|Aspirin|Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.
11996447|NCT00619060|Drug|Topical Myristyl Nicotinate Cream|Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.
11996448|NCT00619060|Drug|Placebo|Participants apply topical placebo to one forearm once daily for 4 weeks.
11996449|NCT00619034|Drug|Latanoprost, diclofenac and dorzolamide (eyedrops)|1 eyedrop twice daily in one week
11996450|NCT00619034|Drug|Diclofenac|dicolfenac eyedrops twice daily i one eye
11996451|NCT00619034|Drug|Dorzolamide|dorzolamide eyedrops twice daily, in one eye for one week
11996596|NCT00618033|Procedure|Hemodialysis|varying concentration of glucose in dialysate
11996454|NCT00619008|Other|Ad libitum High Complex Carbohydrate Diet|6 week ad libitum high complex carbohydrate diet
11996455|NCT00619008|Other|Energy-restricted high complex carbohydrate diet|6 week energy-restricted (68% of estimated energy requirement for weight maintenance) high complex carbohydrate diet.
11996456|NCT00618995|Drug|Comparator: ER niacin (+) laropiprant|ER niacin 2 g/ laropiprant 40 mg daily for 7 days.
11996457|NCT00618995|Drug|Comparator: ER niacin|ER niacin 2 g daily for 7 days.
11996458|NCT00618995|Drug|Comparator: laropiprant|laropiprant 40 mg daily for 7 days.
11996459|NCT00618995|Drug|Comparator: placebo|matching placebo tablets for each of the interventions once daily for 7 days
11996460|NCT00618982|Drug|Sorafenib (Nexavar, BAY43-9006)|The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates.
11996461|NCT00618969|Other|haploidentical allogeneic PBSC transp|"Days -5 and -4: IV busulfan 3.2 mg/kg/dose daily for 2 days
~Day -3: IV melphalan 100 mg/m2 as a single dose
~Days -2 and -1: IV alemtuzumab 30 mg/dose daily for 2 days
~Day 0: Transplantation of haploidentical related allogeneic peripheral blood stem cells (PBSCs)- target cell dose 10 x 106 donor CD34+ cells per kilogram of recipient weight"
11996462|NCT00618956|Drug|Milnacipran hydrochloride|Milnacipran 100 to 200 mg/day tablet (administered in divided doses, twice daily [BID]), oral administration.
11996463|NCT00618956|Drug|Placebo|Placebo
11996464|NCT00618943|Behavioral|Tobacco Use Cessation|The proposed intervention will proceed in three steps. Step 1, provided to all intervention participants, includes multimedia, stage-based, expert-system contacts at intake, 3- and 6-months follow-up supported with brief (15-min) motivational counseling sessions. Step 2, reserved for intervention participants interested in quitting, consists of 12-weeks of individual CBT sessions for smoking cessation. Step 3, a 12-week course of nicotine patch, will be offered to adolescents who enter the CBT Cessation Treatment, who do not have any medical contraindications, and who smoke an average of 5 cigarettes or more per day in the past month.
11996465|NCT00618930|Drug|Moviprep®|use of Moviprep®
11996466|NCT00618930|Drug|Fleet|Use of Fleet
11996467|NCT00618917|Genetic|MnSOD|15 ml of a liquid that contains either 0.3 mg, 3.0 mg or 30.0 mg (depending on which cohort is open when the subject is entered) of MnSOD PL. This will be given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.
11996468|NCT00618904|Dietary Supplement|Probiotics - Lactobacillus and bifidobacterium|Probiotics administered bid for 6 weeks.
11996469|NCT00618904|Dietary Supplement|Placebo|Placebo administered bid for 6 weeks.
11996470|NCT00618878|Procedure|Electroacupuncture|twice a week for 26 treatments in total
11996471|NCT00618878|Procedure|Laser Therapy|twice a week for a total of 26 treatments
11996472|NCT00618865|Dietary Supplement|Omega-3 fatty acids|
11996473|NCT00618852|Drug|Furosemide|The dose of furosemide will be 1 mg/kg by intravenous bolus injection
11996474|NCT00618852|Drug|Saline|1 mg/kg by intravenous bolus injection
11996475|NCT00618839|Biological|StrataGraft Skin Tissue|StrataGraft™ skin tissue is provided as a suturable circular patch of stratified epithelial tissue composed of a living dermal matrix (containing dermal fibroblasts) overlaid with human epidermal cells (NIKS™ cells).
11996476|NCT00618839|Procedure|Cadaver allograft|The standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted.
11996477|NCT00618826|Drug|Paclitaxel|Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
11996478|NCT00618826|Drug|Gemcitabine|Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
11996479|NCT00618826|Drug|Avastin|10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
11996480|NCT00618813|Other|radiation therapy|Undergo radiation therapy
11996481|NCT00618813|Other|therapeutic conventional surgery|Undergo surgery
11996482|NCT00618813|Drug|etoposide|Given IV
11996483|NCT00618813|Drug|ifosfamide|Given IV
11996484|NCT00618813|Drug|doxorubicin hydrochloride|Given IV
11996485|NCT00618813|Drug|cyclophosphamide|Given IV
11996486|NCT00618813|Drug|vincristine sulfate|Given IV
11996487|NCT00618813|Drug|topotecan hydrochloride|Given IV
11996488|NCT00618813|Biological|filgrastim|Given SC
11996489|NCT00618800|Behavioral|Pharmaceutical Care|Participants receive written information about falls prevention and a personal consultation from a community pharmacist concerning their medication regimen. The pharmacist follows up, as required, with participants' physicians to coordinate any recommended medication changes.
11996490|NCT00618800|Other|Written Materials|Participants receive written information about falls prevention.
11996491|NCT00618787|Device|COPA AMD (note: name is not an acronym)|Foam dressing impregnated with Polyhexamethylene Biguanide
11996492|NCT00618787|Device|COPA (note: name is not an acronym)|Regular foam dressing without PHMB
11996493|NCT00618774|Drug|telmisartan40/amlodipine5|
11996494|NCT00618774|Drug|telmisartan80/amlodipine5|
11996495|NCT00618761|Other|hyperglycemic clamp test|hyperglycemic clamp test
11996496|NCT00618748|Drug|Olanzapine|5-20 mg/day, oral, daily
11996497|NCT00618735|Drug|BIIB021|Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
11996498|NCT00618735|Drug|BIIB021|Twice daily dosing
11996499|NCT00618722|Drug|Deoxycholic Acid Injection|
11996500|NCT00618722|Drug|Placebo|
11996501|NCT00618709|Drug|ATX-101|ATX-101 single dose
11996502|NCT00618696|Biological|anti-CD45 monoclonal antibody AHN-12|150 mg/m^2 cold antibody at Day 0
11996503|NCT00618696|Radiation|yttrium Y 90 anti-CD45 monoclonal antibody AHN-12|Dose per scheduled level; 2.5-12.5 mCi/m^2
11996504|NCT00618683|Procedure|Cardiac Invasive Electrophysiological Study|Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study
11996505|NCT00618670|Behavioral|Walking Exercise|Three times per week for 3 months
11996506|NCT00618670|Behavioral|Control--Resistance Training|Three times per week for 3 months
11996507|NCT00618657|Drug|Carboplatin|Given IV
11996508|NCT00618657|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
11996509|NCT00618657|Drug|bevacizumab|Given IV
11996510|NCT00618657|Drug|trastuzumab|Given IV
11996511|NCT00618657|Procedure|magnetic resonance imaging|Optional correlative studies
11996512|NCT00618657|Procedure|therapeutic conventional surgery|Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts
11996513|NCT00618644|Drug|Ranibizumab|Ranibizumab 0.5 mg intravitreal injection
11996514|NCT00618631|Drug|Nicotine|
11996515|NCT00618631|Drug|Carfentanil|
11996516|NCT00618618|Drug|Deoxycholic Acid Injection|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
11996517|NCT00618618|Drug|Placebo|
11996518|NCT00618605|Biological|Ad26.ENVA.01 HIV-1 vaccine|Recombinant adenovirus serotype 26 HIV-1 vaccine
11996519|NCT00618592|Dietary Supplement|PreOp carbohydrate drink|800 mL of PreOp evening before surgery, 400 mL at least two hours before surgery
11996520|NCT00618579|Drug|LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects|Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
11996521|NCT00618566|Behavioral|WPD and Depression Treatment Group|Intervention selected will depend on Phase I data analysis.
11996522|NCT00618553|Other|Questionnaire|Questionnaire regarding quality-of-life that lasts about 30 minutes.
11996523|NCT00618553|Behavioral|Pulmonary Rehabilitation|Rehabilitation treatment given over about 3-4 weeks.
11996524|NCT00618540|Biological|alemtuzumab|Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
11996525|NCT00618540|Drug|fludarabine phosphate|Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3. (dose adjust if age <12 months)
11996526|NCT00618540|Drug|melphalan|Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
11996527|NCT00618540|Procedure|stem cell transplantation|Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation
11996528|NCT00618527|Drug|mycophenolate mofetil (Cellcept)|1 gram po, bid
11996529|NCT00618527|Drug|human interferon beta 1a (Rebif)|44mcg sq injection every other day
11996530|NCT00618514|Device|Bright Tip Laser Fiber|Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber with a fitted ceramic tip on the end. Treatment performed on one leg.
11996531|NCT00618514|Device|Bare Tip Laser Fiber|Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber readily available on the market with a bare tip on the end. Treatment performed on one leg.
11996532|NCT00618501|Drug|cytarabine|
11996533|NCT00618501|Drug|daunorubicin hydrochloride|
11996534|NCT00618501|Drug|etoposide|
11996535|NCT00618501|Drug|imatinib mesylate|
11996536|NCT00618501|Drug|leucovorin calcium|
11996537|NCT00618501|Drug|methotrexate|
11996538|NCT00618501|Drug|prednisolone|
11996539|NCT00618501|Drug|therapeutic hydrocortisone|
11996540|NCT00618501|Drug|vincristine sulfate|
11996541|NCT00618501|Procedure|allogeneic hematopoietic stem cell transplantation|
11996542|NCT00618488|Dietary Supplement|Probiotic BB12 - Bifidobacterium lactis|Bifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks
11996543|NCT00618488|Dietary Supplement|Placebo|Placebo administered once a day for 6 weeks
11996544|NCT00618475|Behavioral|Cognitive behavioral therapy|"10 sessions
~1 hour per week"
11996545|NCT00618462|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include weekly 50-minute sessions for 8 weeks. The sessions will focus on learning skills to cope with urges to gamble and developing alternatives to gambling.
11996546|NCT00618462|Behavioral|Contingency management (CM)|CM will provide incentive, such as a gift certificate to a store or restaurant, for completing activities not related to gambling. Participants and their therapists will decide upon two potential alternative activities to gambling during each therapy session.
11996547|NCT00618462|Behavioral|Psychoeducation therapy|Psychoeducation therapy will include weekly 50-minute therapy sessions for 8 weeks. The sessions will focus on education about gambling and related problems.
11996548|NCT00618462|Behavioral|Case management|Case management will assist participants in obtaining additional services from the community as needed.
11996549|NCT00618462|Behavioral|Gamblers Anonymous (GA)|All participants will be referred to GA, a support group of people who are recovering from gambling addiction, and will be encouraged to attend meetings.
11996550|NCT00618449|Drug|Azithromcyin|1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given 30 days apart; at Day 0 & Day 30 for a total of 2 doses.
11996551|NCT00618449|Drug|Azithromycin|1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given at Day 30 for a total of 1 dose.
11996552|NCT00618436|Drug|Levetiracetam|Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days.
11996553|NCT00618436|Drug|Phenytoin|The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, then started on maintenance dose of 5mg/kg/day, rounded to nearest 100mg dose, IV, q 12h for seven days.
11996597|NCT00618020|Device|CiTop(tm) Guidewire|CiTop(tm)6 Guidewire
11996598|NCT00618007|Drug|PF-00734200 30 mg QD|30 mg QD
11996599|NCT00618007|Drug|PF-00734200 20 mg QD|20 mg QD
11996554|NCT00618423|Drug|Placebo|50 ml syringes provided by the HUG pharmacy will contain 1% ketamine or 0.9% NaCl. After induction and before start of surgery, patients will receive an intravenous bolus of 0.025 ml/kg of the study solution (corresponding to 0.25 mg/kg ketamine). Maintenance will be with a syringe driver at a rate of 0.025 ml/kg/h (corresponding to 0.25 mg/kg/h ketamine) until one hour before the end of surgery, and will then be decreased to a rate of 0.01 ml/kg/h (corresponding to 0.1 mg/kg/h ketamine) throughout the stay in the recovery room (usually 2 to 3 hours). The infusion will be stopped when the patient leaves the recovery room.
11996555|NCT00618423|Drug|Ketamine|50 ml syringes provided by the HUG pharmacy will contain 1% ketamine or 0.9% NaCl. After induction and before start of surgery, patients will receive an intravenous bolus of 0.025 ml/kg of the study solution (corresponding to 0.25 mg/kg ketamine). Maintenance will be with a syringe driver at a rate of 0.025 ml/kg/h (corresponding to 0.25 mg/kg/h ketamine) until one hour before the end of surgery, and will then be decreased to a rate of 0.01 ml/kg/h (corresponding to 0.1 mg/kg/h ketamine) throughout the stay in the recovery room (usually 2 to 3 hours). The infusion will be stopped when the patient leaves the recovery room.
11996556|NCT00618410|Device|Carbon dioxide, USP|Carbon dioxide (CO2) delivered via a nosepiece at a flow rate of 0.5 (± 0.05) SLPM for 10 seconds /nostril
11996557|NCT00618410|Other|Placebo|Nasal placebo
11996558|NCT00618397|Drug|Ketamine|Ketamine administered in doses of 0.01mg/kg/hr, 0.1mg/kg/hr and 0.5mg/kg/hr to PICU patients.
11996559|NCT00618384|Drug|Sorafenib|patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease
11996560|NCT00618371|Drug|Raltegravir (MK-0518)|Antiretroviral drug intensification with Raltegravir (MK0518) 400mg orally every 12 hours for 28 days in addition to the prescribed antiretroviral therapy
11996561|NCT00618358|Device|Vascular Sealant System|The Vascular Sealant System is intended for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
11996562|NCT00618358|Other|Gelfoam/Thrombin|
11996563|NCT00618345|Drug|everolimus|
11996564|NCT00618345|Genetic|DNA analysis|
11996565|NCT00618345|Genetic|protein analysis|
11996566|NCT00618345|Genetic|western blotting|
11996567|NCT00618345|Other|flow cytometry|
11996568|NCT00618345|Other|laboratory biomarker analysis|
11996569|NCT00618345|Procedure|biopsy|
11996570|NCT00618332|Drug|mometasone furoate nasal spray|2 puffs in each nostril once a day for 2 weeks
11996571|NCT00618332|Drug|placebo|2 puffs in each nostril once a day for 2 weeks
11996572|NCT00618319|Drug|BIIB021|Dose, schedule, and duration specified in protocol
11996573|NCT00618293|Drug|Haemate HS|intravenous infusion of Haemate (dosage dependent on body weight)
11996574|NCT00618293|Other|NaCl-solution|intravenous infusion of 0.9%NaCl-Solution
11996575|NCT00618280|Drug|nicotine nasal spray|0,5 mg nicotine nasal spray or placebo (pepperspray)
11996576|NCT00618254|Drug|Granisetron|
11996577|NCT00618241|Drug|lamotrigine|100 mg
11996578|NCT00618241|Drug|Raltegravir|400 mg BD
11996579|NCT00618228|Drug|Balsalazide|
11996580|NCT00618215|Behavioral|peer group educational implementation strategy|"Delivery CPG
~Education session IQual group
~Online training website (individual feed back)
~Reminder (flow chart), individual feed back record form
~Feed back by email
~Registration in practice"
11996581|NCT00618202|Drug|Balsalazide|
11996582|NCT00618176|Drug|Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)|Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W>60Kg)125mg bid (W<60Kg) Nevirapine (NVP) 200mg bid
11996583|NCT00618176|Drug|Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)|Stavudine (d4T) 30mg bid (W>60Kg)20mg bid (W<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid
11996584|NCT00618176|Drug|Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)|Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid
11996585|NCT00618163|Drug|Meloxicam|
11996586|NCT00618150|Behavioral|Patient education|An educational program: Three lessons spaced over 2 weeks.
11996587|NCT00618124|Drug|SU011248; Capecitabine|Dose finding study using SU011248 daily by oral capsule in a continuous regimen or administered for 4 out of every 6 weeks (Schedule 4/2) or 2 out of every 3 weeks (Schedule 2/1), with capecitabine administered 2 out of every 3 weeks until progression or unacceptable toxicity.
11996588|NCT00618111|Drug|Granisetron|
11996589|NCT00618098|Biological|Octaplex (human prothrombin complex concentrate)|INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum dose for initial treatment was not to exceed 5500 IU. If the INR is ≥ 1.5 after the initial infusion, additional infusions will be repeated until the INR was < 1.5. Octaplex (500 units, IU) is supplied in vials and was reconstituted with 20 mL of Water for Injection (Ph.Eur.).
11996590|NCT00618098|Biological|Fresh frozen plasma|INR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of < 3 and 15 mL/kg for a participant with an initial INR of ≥ 3. If the INR is ≥ 1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was < 1.5. Fresh frozen plasma is supplied by the blood bank at each study site and will be prepared and handled according to the site's standard practice.
11996591|NCT00618085|Behavioral|Motor imagery practice|During motor imagery practice a person imagines performing a skill or movement with all its sensory consequences without actually moving. In this study the therapists follow a motor imagery guideline designed for rehabilitation of skills and movement performance in subjects with neurological disease or damage. The guideline offers therapists structure and a strategy to deliver subject-specific imagery. The guideline is based on three major frameworks, namely; principles of motor learning, phased process of human movement and a training guide for sports coaches and performers from the National Coaching Foundation.
11996592|NCT00618085|Other|Standard physiotherapy and occupational therapy|Patients with neurological disease or damage will receive standard physiotherapy and occupational therapy.
11996593|NCT00618072|Drug|metformin and rosiglitazone|4 week dosage escalation of metformin, 500 mg/day (or placebo) to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day(or placebo) added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
11996594|NCT00618059|Drug|Pilocarpine|
11996595|NCT00618046|Drug|Oxcarbazepine|
11996600|NCT00618007|Drug|Placebo|Placebo
11996602|NCT00617981|Drug|ThermoDox|Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
11996603|NCT00617981|Drug|5% Dextrose Solution|Single 30 minute intravenous infusion
11996604|NCT00617968|Drug|DOCETAXEL|
11996605|NCT00617955|Drug|Aprotinin|compare outcomes of Aprotinin versus Amicar
11996606|NCT00617955|Drug|Amicar|compare outcomes of Aprotinin versus Amicar
11996607|NCT00617942|Drug|Cohort 1 neo-adjuvant|"Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
11996608|NCT00617942|Drug|Cohort 2 neo-adjuvant|Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
11996609|NCT00617942|Drug|Cohort 1 adjuvant|Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
11996610|NCT00617942|Drug|Cohort 2 adjuvant|Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
11996611|NCT00617929|Biological|anti-thymocyte globulin|administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
11996612|NCT00617929|Biological|rituximab|administered 375 mg/m^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
11996613|NCT00617929|Drug|clofarabine|administered 30 mg/m^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
11996614|NCT00617929|Procedure|stem cell transplantation|administered on Day 0 per institutional guidelines.
11996615|NCT00617903|Drug|Azelaic acid|15% foam to be applied topically twice daily
11996616|NCT00617903|Drug|Vehicle foam|Active-ingredient-free vehicle to be applied topically twice daily
11996617|NCT00617890|Biological|robatumumab|Robatumumab IV every two weeks until disease progression.
11996618|NCT00617877|Drug|losartan potassium|Losartan 50 mg/day for 4 weeks, then doubled to losartan 100 mg/day (in case of BP more than 140/90 mm Hg.) Continued until the end of the study (visit 9-week 48).
11996619|NCT00617877|Drug|Comparator: Hydrochlorothiazide|Hydrochlorothiazide 25 mg will be added at week 8 if BP is more than 140/90 mm Hg. This last regimen will be continued until the end of the study (visit 9-week 48).
11996620|NCT00617864|Drug|Human Albumin Infusion|Group will receive single infusion of albumin at the time of oocyte retrieval.
11996621|NCT00617864|Drug|Saline Infusion|Group will receive single infusion of saline at the time of oocyte retrieval.
11996622|NCT00617851|Biological|Lot A of Influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
11996623|NCT00617851|Biological|Lot B of Influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
11996624|NCT00617851|Biological|Lot C of Influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
11996625|NCT00617851|Biological|Comparator influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
11996626|NCT00617851|Biological|All 3 consecutive lots of influenza virus vaccine pooled|1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
11996627|NCT00617838|Other|Optimal gluten introduction|Optimization of gluten introduction by nutritional counselling
11996628|NCT00617825|Other|cyrotherapy as a cool gel wrap|A cool gel wrap made of a hydrogel with silicon will be applied to the lower leg of skin affected by venous disorders for 30 minutes each day for 30 days during the study
11996629|NCT00617812|Biological|Shan5|Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
11996630|NCT00617799|Biological|aldesleukin|
11996631|NCT00617799|Genetic|gene expression analysis|
11996632|NCT00617799|Genetic|mutation analysis|
11996633|NCT00617799|Other|flow cytometry|
11996634|NCT00617786|Procedure|Current Perception Threshold (CPT) Testing|During the CPT testing a catheter will be placed in the bladder. The catheter has sensors to record the body's sensation of pressure. The sensation felt will be similar to a light touch and is painless. A gel pad will be placed in the general area of the vagina to record the feeling of a light touch.
11996635|NCT00617773|Biological|hu3S193|20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
11996636|NCT00617760|Biological|Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)|MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle, PCV7 (0.5 ml) to be administered in the right thigh muscle
11996637|NCT00617760|Biological|7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)|PCV7 (0.5 ml) to be administered in the right thigh muscle
11996638|NCT00617760|Biological|Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)|MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle
11996639|NCT00617747|Drug|Zolmitriptan|5mg Nasal Spray
11996640|NCT00617747|Drug|Placebo|
11996641|NCT00617734|Biological|IMC-A12 (cixutumumab)|IMC-A12 10 milligrams per kilogram (mg/kg) over one hour every two weeks. A cycle is defined as four weeks of therapy. Participants will continue on study until evidence of progressive disease, or unacceptable toxicity develops.
11996642|NCT00617734|Biological|cetuximab (Erbitux ®)|IMC-A12 10 mg/kg over one hour followed by cetuximab 500 milligrams per square meter (mg/m^2) over two hours. This sequence will be repeated every two weeks. Participants will continue on study until evidence of progressive disease or unacceptable toxicity develops.
11996643|NCT00617721|Other|Blood withdrawal|Observational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status.
11996644|NCT00617708|Biological|cixutumumab|Given IV
11996645|NCT00617708|Drug|erlotinib hydrochloride|Given PO
11996646|NCT00617708|Drug|gemcitabine hydrochloride|Given IV
11996647|NCT00617695|Drug|Zolmitriptan|5mg nasal spray
11996648|NCT00617695|Drug|Placebo|
11996649|NCT00617682|Biological|PNCRM9|0.5 mL IM at 30-35 wks gestation
11996736|NCT00617240|Drug|placebo|500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks
11996650|NCT00617682|Biological|Placebo comparator|Sucrose cake (NaCl and sucrose) in aluminum phosphate adjuvant diluent at 0.5 mg per 0.5 mL dose IM at 30-35 wks gestation
11996651|NCT00617669|Drug|Docetaxel|intravenous infusion given every three weeks
11996652|NCT00617669|Drug|ZD4054|10 mg oral once daily dose
11996653|NCT00617669|Drug|Placebo|placebo oral tablet once daily
11996654|NCT00617656|Drug|Cisplatin, Docetaxel|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
11996655|NCT00617656|Drug|Gemcitabine, Cisplatin|Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
11996656|NCT00617656|Drug|Docetaxel, Cisplatin|Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
11996657|NCT00617656|Drug|Docetaxel|Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
11996658|NCT00617643|Drug|Nevirapine without dose escalation|Fixed dose combination tablets of stavudine 30mg,lamivudine 150mg and nevirapine tablets 200mg twice daily at initiation of antiretroviral therapy in patients receiving rifampicin for tuberculosis therapy
11996659|NCT00617643|Drug|Nevirapine initiation with dose escalation|Triomune® 30 (according to body weight) one tablet once daily (am) plus Zerit® 30 + Epivir 150mg once daily (pm) for two weeks
11996660|NCT00617617|Dietary Supplement|Prevastein HC®|Experimental Group - Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones.
11996661|NCT00617617|Other|Placebo|Control Group - Control Group participants will receive an identical placebo.
11996662|NCT00617604|Drug|Alefacept|IV and subcutaneous injection
11996663|NCT00617604|Drug|placebo|IV and subcutaneous injection
11996664|NCT00617604|Drug|Tacrolimus|The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
11996665|NCT00617604|Drug|Mycophenolate Mofetil|Mycophenolic mofetil was administered as 750 mg twice per day orally
11996666|NCT00617604|Drug|Steroids|"Methylprednisolone or equivalent:
~Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
~Prednisone or equivalent:
~Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally"
11996667|NCT00617591|Drug|Lenalidomide|25 mg orally on days 1-21
11996668|NCT00617591|Drug|Pegylated Liposomal Doxorubicin (PLD)|40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated)
11996669|NCT00617591|Drug|Dexamethasone|40 mg orally on days on 1-4
11996670|NCT00617578|Device|ATP One Shot ON|"The new antitachycardia pacing algorithm ATP One Shot attempts to terminate fast VT by one ATP sequence and thus avoid defibrillation shock delivery"
11996671|NCT00617578|Device|ATP One Shot OFF|Standard defibrillation shock delivery
11996672|NCT00617565|Drug|biphasic insulin aspart|
11996673|NCT00617565|Drug|biphasic human insulin|
11996674|NCT00617552|Drug|5% dextrose in water|60 ml IV infusion over 30 minutes
11996675|NCT00617552|Drug|TZP-101|20 micrograms/kg IV 2ml/minute for 30 minutes
11996676|NCT00617552|Drug|TZP-101|40 micrograms/kg IV 2 ml/minute for 30 minutes
11996677|NCT00617552|Drug|TZP-101|80 micrograms/kg IV 2ml/minute for 30 minutes
11996678|NCT00617552|Drug|TZP-101|160 micrograms/kg IV 2ml/minute over 30 minutes
11996679|NCT00617552|Drug|TZP-101|320 micrograms/kg IV 2ml/minute for 30 minutes
11996680|NCT00617552|Drug|TZP-101|480 micrograms/kg IV 2ml/minute over 30 minutes
11996681|NCT00617552|Drug|TZP-101|600 micrograms/kg IV 2ml/minute for 30 minutes
11996682|NCT00617539|Drug|irinotecan hydrochloride|
11996683|NCT00617539|Drug|temozolomide|
11996684|NCT00617526|Drug|RDEA806 400 mg|
11996685|NCT00617526|Drug|Placebo|Placebo
11996686|NCT00617526|Drug|RDEA806 1000 mg|
11996687|NCT00617526|Drug|RDEA806 600 mg|
11996688|NCT00617526|Drug|RDEA806 800 mg|
11996689|NCT00617513|Drug|Prucalopride|0.5 mg once daily
11996690|NCT00617513|Other|Placebo|o.d.
11996691|NCT00617513|Drug|Prucalopride|1 mg o.d.
11996692|NCT00617513|Drug|Prucalopride|2 mg o.d.
11996693|NCT00617500|Other|flower therapy|Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
11996694|NCT00617500|Other|therapeutic touch|Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
11996695|NCT00617500|Other|auricular therapy|Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
11996696|NCT00617500|Drug|Hormones|Estradiol 1 mg and a drospirenone 2mg/day (3 months)
11996697|NCT00617474|Drug|Erythropoietin|sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.
11996698|NCT00617474|Drug|Placebo|placebo
11996699|NCT00617461|Drug|GEn 1200mg/day|1200mg/day gabapentin enacarbil
11996700|NCT00617461|Drug|GEn 3600mg/day|3600mg/day gabapentin enacarbil
11996701|NCT00617448|Procedure|diathermy haemorrhoidectomy under espinal anesthesia|For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.
11996702|NCT00617448|Procedure|diathermy haemorrhoidectomy under local anesthesia|For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan). For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
11996703|NCT00617448|Procedure|Ligasure haemorrhoidetomy under spinal anestesia|For surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.
11996737|NCT00617201|Drug|atomoxetine|Once daily oral dosing
11996738|NCT00617201|Drug|placebo|Once daily oral dosing - matched placebo
11996739|NCT00617188|Drug|Fulvestrant|Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.
11996704|NCT00617448|Procedure|Ligasure haemorrhoidectomy under local anesthesia|For surgery: haemorrhoidectomy with Ligasure For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
11996705|NCT00617435|Dietary Supplement|vaccenic acid enriched diet|"The experimental milk fat, entitled vaccenic acid enriched milk fat (VAMF), has been obtained by feeding cows with a diet containing sunflower oil."
11996706|NCT00617435|Dietary Supplement|Elaidic acid enriched diet|Mixture of vegetable oils (including partially hydrogenated oils)
11996707|NCT00617435|Dietary Supplement|control diet|Mixed of different oil
11996708|NCT00617409|Drug|Paclitaxel|All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads. At any point when a patient develops evidence of progressive disease, the patient will be treated with second-line chemotherapy. Paclitaxel will be given at a dose of 200 mg/m² on day 1 of 21 day cycles.
11996709|NCT00617409|Biological|Drug: Ad.p53-DC vaccines|Patients randomized to Arm B will receive vaccinations on 3 occasions, at 2 week intervals. 1-5x106 p53 positive DCs in 1 ml will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2-3 weeks after vaccine # 3 (first vaccine course). If patients show no sign of disease progression at restaging, then a second leukopheresis will be performed. Patients will then be vaccinated 3 more times (second vaccine course) at 4-week intervals, for a total of 6 possible vaccines. Restaging will occur 2-4 weeks after completing the second vaccine course. Patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).
11996710|NCT00617409|Drug|All -trans Retinoic Acid (ATRA)|The patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).
11996711|NCT00617396|Drug|Quetiapine (50 mg/day-100mg/day)|Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)
11996712|NCT00617370|Drug|epirubicin, cyclophosphamide, Paclitaxel,|EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg). Paclitaxel (175 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg).
11996713|NCT00617357|Device|LTM (Strattice Reconstructive Tissue Matrix)|Surgical mesh
11996714|NCT00617344|Biological|Tetravalent CYD Dengue Vaccine , 5555 formulation|A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
11996715|NCT00617344|Biological|Tetravalent CYD Dengue Vaccine , 5553 formulation|A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
11996716|NCT00617344|Biological|Tetravalent CYD Dengue Vaccine, 4444 formulation|A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
11996717|NCT00617331|Biological|Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine|Inactivated subvirion influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine administered via intramuscular (IM) injection, dose 7.5 or 30 micrograms.
11996718|NCT00617318|Dietary Supplement|Pomegranate|"All subjects were randomized and assigned to a 16-week treatment with either POM concentrate or placebo. The placebo matched the taste, smell, and appearance of the POM concentrate. Supplies were shipped to the investigation site in equal proportions marked as A and B, and site personnel did not know the code. The treatment products (POM concentrate or placebo) were supplied as 2-oz packages, each containing a single day's consumption, and were dispensed as packages of 33 units (a 4-week plus 5-day supply). The subjects were to consume one 2 oz. package daily for a period of 16 weeks."
11996719|NCT00617318|Dietary Supplement|Placebo|"All subjects were randomized and assigned to a 16-week treatment with either POM concentrate or placebo. The placebo matched the taste, smell, and appearance of the POM concentrate. Supplies were shipped to the investigation site in equal proportions marked as A and B, and site personnel did not know the code. The treatment products (POM concentrate or placebo) were supplied as 2-oz packages, each containing a single day's consumption, and were dispensed as packages of 33 units (a 4-week plus 5-day supply). The subjects were to consume one 2 oz. package daily for a period of 16 weeks."
11996720|NCT00617305|Drug|Ambrisentan|Ambrisentan was administered orally once daily; dose level was 5 mg for the first 4 weeks, followed by 10 mg for the remainder of the study; ambrisentan was supplied as 5-mg and 10-mg tablets.
11996721|NCT00617305|Drug|Placebo|Placebo to match ambrisentan was administered orally once daily.
11996722|NCT00617305|Drug|Sildenafil|Sildenafil was administered at the dose previously established for each subject (20-100 mg) orally three times daily. Sildenafil was supplied as 20-mg tablets, or formulated as sildenafil citrate in 25-, 50-, or 100-mg tablets.
11996723|NCT00617305|Drug|Tadalafil|Tadalafil was administered at the dose previously established for each subject (not to exceed 40 mg per day) orally once daily. Tadalafil was supplied as 20-mg tablets.
11996724|NCT00617279|Device|GORE PROPATEN Vascular Graft|Arterial Occlusion Bypass
11996725|NCT00617279|Procedure|Disadvantaged Autologous Vein Graft|Arterial Occlusion Bypass
11996726|NCT00617266|Other|tobacco cessation intervention|Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only
11996727|NCT00617266|Other|Tobacco cessation intervention|Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
11996728|NCT00617266|Other|Tobacco cessation intervention|Distribution of pamphlets containing information on the hazards of tobacco
11996729|NCT00617266|Other|Tobacco cessation intervention|Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
11996730|NCT00617253|Drug|recombinant interleukin-21|3 mcg/kg, s.c. injection
11996731|NCT00617253|Drug|sunitinib|Hard gelatine capsules, 12.5 mg
11996732|NCT00617253|Drug|recombinant interleukin-21|10 mcg/kg, s.c. injection
11996733|NCT00617253|Drug|recombinant interleukin-21|30 mcg/kg, s.c. injection
11996734|NCT00617253|Drug|recombinant interleukin-21|100 mcg/kg, s.c. injection
11996735|NCT00617240|Drug|metformin|500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks
11996891|NCT00616122|Drug|sunitinib malate|
11996740|NCT00617175|Device|Implantable Defibrillator|Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
11996741|NCT00617175|Device|Implantable Defibrillator|number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
11996742|NCT00617149|Behavioral|Supervised exercise for the prevention high weight gain|Each session starts with ca 5 minutes warm up, followed by 30 minutes of aerobic activity, including cool down. This is followed by 15 minutes of strength training of the upper and lower limbs, and special focus on the deep abdominal stabilization muscles. The last 5 minutes contains stretching, relaxation and body awareness exercises. The exercise-program follows the ACOG exercise prescription, and all aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate), measured by ratings of perceived exertion at 11-14 (somewhat hard) on the 6-20 Borg's rating scale. Control-participants are neither encouraged nor discouraged from exercising.
11996743|NCT00617136|Device|Intraoperative warming (Bair Hugger)|Intraoperative warming
11996744|NCT00617136|Device|Pre- and intraoperative warming (HotDog)|Pre- and intraoperative warming by HotDog
11996745|NCT00617136|Device|Intraoperative warming (HotDog)|Intraoperative warming
11996746|NCT00617123|Drug|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg oral tablet
11996747|NCT00617123|Drug|Placebo|matching placebo oral tablet
11996748|NCT00617110|Other|live attenuated influenza virus (LAIV) with clean air|Allergic subjects will be exposed to air followed by administration of live attenuated influenza virus
11996749|NCT00617110|Other|LAIV and diesel exhaust particles|subjects with allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV
11996750|NCT00617097|Drug|lidocaine|paracervical block with lidocaine
11996751|NCT00617097|Drug|ketorolac and lidocaine|paracervical block with ketorolac and lidocaine
11996752|NCT00617084|Device|Medtronic Endeavor Resolute|Medtronic Endeavor Resolute
11996753|NCT00617084|Device|Abbott Xience V|Abbott Xience V
11996754|NCT00617071|Other|medical chart review|
11996755|NCT00617071|Other|survey administration|
11996756|NCT00617071|Procedure|fecal occult blood test|
11996757|NCT00617071|Procedure|screening colonoscopy|
11996758|NCT00617058|Drug|metformin|open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
11996759|NCT00617058|Behavioral|healthy lifestyle intervention|additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
11996760|NCT00617045|Drug|duloxetine|"Total treatment period is 12 weeks
~30mg po qd times 1 week
~60mg po qd times 11 weeks"
11996761|NCT00617032|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^10 DNase resistant particles (DRP) / mL joint volume
11996762|NCT00617032|Genetic|tgAAC94 gene therapy vector|Single dose 1x10^11 DNase resistant particles (DRP) / mL joint volume
11996763|NCT00617032|Genetic|tgAAC94 placebo|Single dose
11996764|NCT00616993|Drug|Difluprednate|Difluprednate
11996765|NCT00616993|Other|Placebo|Vehicle
11996766|NCT00616980|Biological|CD34-positive cells|
11996767|NCT00616980|Biological|CD34-positive cells|
11996768|NCT00616980|Biological|Saline and 5% autologous plasma|
11996769|NCT00616967|Drug|carboplatin|Given IV
11996770|NCT00616967|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
11996771|NCT00616967|Drug|vorinostat|Given orally
11996772|NCT00616967|Other|placebo|Given orally
11996773|NCT00616954|Drug|ATG-F|ATG-f
11996774|NCT00616941|Biological|NY-ESO-1 OLP4|1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of 5% dextrose in water (D5W) and administered subcutaneously as a single injection.
11996775|NCT00616941|Biological|NY-ESO-1 OLP4 + Montanide|1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.
11996776|NCT00616941|Biological|NY-ESO-1 OLP4 + Montanide + Poly-ICLC|1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.
11996777|NCT00616928|Biological|Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted|Two intramuscular injections at Days 0 and 21.
11996778|NCT00616928|Biological|Placebo|Two intramuscular injections at Days 0 and 21.
11996779|NCT00616915|Drug|Wellbutrin XL|Wellbutrin XL 300mg daily
11996780|NCT00616902|Drug|paricalcitol injection 4 mcg/mL|Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis
11996781|NCT00616902|Drug|Placebo Injection 4 mcg/mL|Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
11996782|NCT00616889|Drug|Seroquel|The dosage is flexible from 50-600 mg based on the investigator's clinical judgement and patient tolerance. It may be raised or lowered at will.
11996783|NCT00616876|Drug|Lactulose|Babies in the study group received lactulose in a dose of 1% in their entire mother's breast milk or preterm formula feeds (1 gram per 100 ml feeds, based on the daily volume of feeds, and evenly distributed between all the feeds for the entire duration of their hospital stay). 67% lactulose in the original preparation (Laevolac, Fresenius Kabi, Austria) was diluted by distilled water to 33.5% preparation in the pharmacy in strict sterile conditions under hood. Just before feeding the nurses added the required volume of this 33.5% lactulose solution to the ordered volume of feed to generate a final concentration of 1% lactulose in each feed.
11996784|NCT00616876|Dietary Supplement|Dextrose|Babies in the control groups were given equal volumes of the comparable placebo in all their preterm formula feeds at final concentration of 1% dextrose. The 33.5% dextrose placebo solution was prepared by dissolving dextrose (Dextrose Pulv. USP.24/BP, Roquette Frores 6280, Lestrem, France) in distilled water under heat to the point of near boiling under the same strict sterile conditions in the pharmacy. This gave a placebo solution that looked similar in color, odor and liquidity to the study solution of 33.5% lactulose. Dark bottles were used to further blind the medical team as to what solution was the baby given.
11996785|NCT00616863|Drug|Oxcarbazepine|
11996786|NCT00616850|Procedure|Continuous femoral catheter block|A constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A.
11996787|NCT00616850|Drug|Lidocaine|Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
11996788|NCT00616850|Other|Preservative free normal saline|Preservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
11996789|NCT00616837|Other|Telemedicine consultation|Outpatient consultation by help of telemedicine (video conference)
11996790|NCT00616837|Other|Standard care in orthopaedic outpatient clinic|Standard care in orthopedic outpatient clinic (usual care)
11996791|NCT00616824|Procedure|Dermamatrix to cover lateral aspect of tissue expander|Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
11996792|NCT00616824|Procedure|Serratus anterior to cover lateral aspect of tissue expander|Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
11996793|NCT00616811|Drug|vildagliptin|
11996794|NCT00616811|Drug|Sitagliptin|
11996795|NCT00616798|Drug|RO4917838|10mg po daily
11996796|NCT00616798|Drug|RO4917838|30mg po daily
11996797|NCT00616798|Drug|RO4917838|60mg po daily
11996798|NCT00616798|Drug|Placebo|po daily
11996799|NCT00616798|Drug|Standard antipsychotic therapy|As prescribed
11996800|NCT00616785|Drug|cisplatin|
11996801|NCT00616785|Drug|etoposide|
11996802|NCT00616785|Drug|irinotecan hydrochloride|
11996803|NCT00616785|Radiation|radiation therapy|
11996804|NCT00616772|Drug|ABT-335|Capsule
11996805|NCT00616772|Drug|Placebo|Capsule
11996806|NCT00616772|Other|Atorvastatin|Capsule
11996807|NCT00616759|Procedure|electroconvulsive therapy|electroconvulsive therapy as usual
11996808|NCT00616759|Procedure|electroconvulsive therapy plus propofol|electroconvulsive therapy identical to the comparator group except that propofol 0.5 mg/kg is given intravenously 15 seconds after the electrical stimulation at each treatment in order to terminate the ECT-induced seizure
11996809|NCT00616759|Drug|propofol|Propofol 0.5 mg/kg intravenously given 15 seconds following electrical stimulation
11996810|NCT00616746|Drug|Nicotine|1.0 microg/kg/min IV x 10 minutes
11996811|NCT00616746|Drug|Ethanol|IV
11996812|NCT00616733|Drug|CS-0777 tablets|0.1 mg, once-weekly, for 12 weeks
11996813|NCT00616733|Drug|CS-0777 tablets|0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
11996814|NCT00616733|Drug|CS-0777 tablets|0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
11996815|NCT00616720|Biological|aldesleukin|
11996816|NCT00616720|Biological|idiotype-pulsed autologous dendritic cell vaccine APC8020|
11996817|NCT00616720|Biological|recombinant interferon gamma|
11996818|NCT00616720|Genetic|polymerase chain reaction|
11996819|NCT00616720|Genetic|reverse transcriptase-polymerase chain reaction|
11996820|NCT00616720|Other|flow cytometry|
11996821|NCT00616720|Other|laboratory biomarker analysis|
11996822|NCT00616694|Drug|Actonel|Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)
11996823|NCT00616681|Drug|Oxcarbazepine|
11996824|NCT00616668|Device|Air- Limb|
11996825|NCT00616655|Drug|eszopiclone|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
11996826|NCT00616655|Drug|eszopiclone|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
11996827|NCT00616655|Drug|Placebo|Placebo total daily dose 0.9 mg
11996828|NCT00616642|Drug|rosiglitazone maleate|Given orally
11996829|NCT00616629|Drug|AZD1305|Intravenous infusion
11996830|NCT00616616|Procedure|single incision laparoscopic surgery|Surgery will be performed with ine laparoscopic incision
11996831|NCT00616603|Drug|Ropivacaine|20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.
11996832|NCT00616603|Drug|Dexamethasone|8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once.
11996833|NCT00616603|Drug|Dexamethasone|2ml(8mg)Dexamethasone given once intravenously.
11996834|NCT00616603|Drug|Normal Saline|2ml of normal saline given once intravenously.
11996835|NCT00616590|Other|medical chart review|
11996836|NCT00616590|Other|questionnaire administration|
11996837|NCT00616590|Procedure|fatigue assessment and management|
11996838|NCT00616590|Procedure|quality-of-life assessment|
11996839|NCT00616577|Drug|Ropivacaine|caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
11996840|NCT00616577|Drug|Ropivacaine|caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
11996841|NCT00616577|Drug|Ropivacaine|local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site
11996842|NCT00616564|Drug|GM-CSF|Concomitant Priming with GM-CSF
11996843|NCT00616551|Drug|C2L-OCT-01 PR, 30 mg|Administered by deep IM injection (gluteus) on days 1 and 42
11996844|NCT00616551|Drug|Octreotide acetate prolonged release, 30 mg|Administered by deep IM (gluteus) on Days 1, 28 and 56
11996845|NCT00616538|Device|Epiceram(r)|Topical barrier repair emulsion cream
11996846|NCT00616538|Drug|Fluticasone Propionate 0.05%|Topical mid-strength steroid
11996847|NCT00616512|Procedure|GF Strong Water Protocol|The Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol.
11996848|NCT00616499|Drug|gefitinib|
11996849|NCT00616499|Procedure|neoadjuvant therapy|
11996850|NCT00616499|Procedure|therapeutic conventional surgery|
11996851|NCT00616486|Device|repetitive transcranial magnetic stimulation|6 weeks of stimulation with RMT frequency 1Hz, intensity 110% of RMT for 20 minutes, 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
11996852|NCT00616486|Device|sham (placebo)|Sham treatment will mimic active treatment mentioned above.
11996853|NCT00616460|Drug|Bivalirudin|Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT < 250
11996892|NCT00616122|Other|laboratory biomarker analysis|
11996893|NCT00616109|Drug|sunitinib|Sunitinib will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
11996894|NCT00616096|Procedure|immunoadsorption|"First cycle: week 1, day 1-5
~Second cycle: week 5, day 1-5"
11996854|NCT00616447|Device|Repetitive transcranial magnetic stimulation|6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
11996855|NCT00616447|Device|placebo sham|Sham treatment will mimic active treatment mentioned above.
11996856|NCT00616434|Drug|BG9418 (Interferon beta-1a)|Avonex IM injection, self-administered per protocol
11996857|NCT00616434|Drug|Placebo|Placebo IM injection, self-administered per protocol.
11996858|NCT00616421|Biological|MenACWY-CRM|1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
11996859|NCT00616421|Biological|MenACWY-CRM|2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
11996860|NCT00616421|Biological|Licensed meningococcal ACWY vaccine|1 injection of the licensed meningococcal ACWY was administered intramuscularly
11996861|NCT00616408|Drug|Octreotide-LAR|Initial dose is 20 mg every 28 d for three months, then the dose is down-titrated to 10 mg/q28d if GH levels are below 1 ng/ml, up-titrated to 30 mg/q28d if GH levels are above 10 ng/ml and remains to 20 mg/q28 d if GH is between 1-10 ng/ml
11996862|NCT00616395|Device|No intervention|
11996863|NCT00616382|Drug|Indomethacin|IV indomethacin starting at a dose of 0.4 mg/kg given over 30 minutes, increased daily by increments of 0.2 mg/kg/dose and given at intervals of 12 hours until a maximum dose of 1 mg/kg is reached, or until a total indomethacin dose of 6 mg/kg has been given. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later, using the same dose used in the last indomethacin infusion.
11996864|NCT00616382|Drug|Pentoxifylline|IV indomethacin will be re-started at a dose of 0.2 mg/kg to run over 30 minutes at 12 hour intervals to be given concurrently with pentoxifylline (5 mg/kg/hour to run over 6 hour once a day for a maximum of 6 days. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later and another day of pentoxifylline infusion, provided that the 6 day maximum has not yet been
11996865|NCT00616343|Drug|Zonisamide|100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
11996866|NCT00616330|Drug|clindamycin phosphate/butoconazole nitrate|semi solid, single dose
11996867|NCT00616330|Drug|clindamycin phosphate|semi solid, single dose
11996868|NCT00616330|Drug|butoconazole nitrate|semi solid, single dose
11996869|NCT00616304|Drug|L-arginine hydrochloride|Patients will be randomized in two blocks of 18. The first block of 18 patients will receive either 12 g L-arginine or saline placebo. If safety is demonstrated in the first block, a further 18 patients will be enrolled in the second block and randomized to receive either 24g arginine or saline placebo Block 1: Standard RSMM artesunate regimen for severe falciparum malaria plus 12g of L-arginine diluted to a 10% solution and given over 8 hours (n=12); Block 2: Standard RSMM artesunate regimen for severe falciparum malaria plus a 24g dose of L-arginine diluted to a 10% solution given over 8 hours (n=12) Phase 2b: To evaluate any additional benefits of a longer infusion, a further 24 patients will receive L-arginine infusion 1.5g/hour for 24 hours
11996870|NCT00616304|Other|Normal saline|Patients with severe malaria will be randomized in two blocks of 18. The first block of 18 patients will receive either 12 g L-arginine or saline placebo. If safety is demonstrated in the first block, a further 18 patients will be enrolled in the second block and randomized to receive either 24g arginine or saline placebo. Blocks 1 and 2: Standard RSMM antimalarial artesunate regimen for severe falciparum malaria plus saline placebo, 240 ml given over 8 hours (n=12).
11996871|NCT00616291|Biological|NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine|
11996872|NCT00616265|Device|CPAP|Pressure device on airway to maintain it open
11996873|NCT00616239|Drug|20-30% Salicylic Acid peels to the right side of the face|Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.
11996874|NCT00616239|Drug|20-30% Salicylic Acid peels to the left side of the face|Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face
11996875|NCT00616213|Biological|filgrastim|filgrastim will be administered at a standard dose and schedule
11996876|NCT00616213|Drug|PR104|PR104 is administered intravenously once every 21 days
11996877|NCT00616213|Other|F-18-fluoromisonidazole|F-18-fluoromisonidazole is administered intravenously prior to performance of PET scan
11996878|NCT00616200|Other|Very low carbohydrate diet|4 weeks on strictly controlled low carbohydrate diet
11996879|NCT00616187|Drug|interferon beta treatment to add-on atorvastatin treatment|IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
11996880|NCT00616187|Drug|untreated to atorvastatin treatment|no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
11996881|NCT00616174|Procedure|Active warming with Bair Hugger blanket|Standard care at BC Women's Hospital plus a Bair Hugger full access underbody blanket model 635 (Health Canada Licence # 12692) warmed by Bair Hugger temperature management unit model 750. Patient will lie on the underbody blanket and it will be turned on once patient is supine on operating table following the insertion of anesthetic. The warming device will be set to the medium temperature setting (380C). Warming will continue until the end of surgery unless otherwise requested by the mother.
11996882|NCT00616161|Drug|Istaroxime|0.5 microgram/kg/min IV for 6 hours
11996883|NCT00616161|Drug|Istaroxime|1.0 microgram/kg/min IV for 6 hours
11996884|NCT00616161|Drug|Istaroxime|1.5 microgram/kg/min IV for 6 hours
11996885|NCT00616161|Drug|Placebo|Placebo
11996886|NCT00616148|Drug|YKP3089|Oral dosage form
11996887|NCT00616148|Drug|Placebo|
11996888|NCT00616135|Procedure|ADRC-Enhanced Autologous Fat Transplant|Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.
11996889|NCT00616122|Drug|cyclophosphamide|
11996890|NCT00616122|Drug|methotrexate|
11996897|NCT00616057|Dietary Supplement|Synergy 1|8 grams/day during the first week and then 8 grams twice a day during 3 months
11996898|NCT00616057|Dietary Supplement|maltodextrin|8 grams/day during the first week and then 8 grams twice a day during 3 months
11996899|NCT00616044|Procedure|continuous spinal anesthesia|bupivacaina isobaric 0.5%, 5 mg
11996900|NCT00616044|Procedure|Spinocath a catheter for continuous spinal anesthesia|Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric
11996901|NCT00616044|Procedure|combined spinal epidural anesthesia|CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany
11996902|NCT00616031|Drug|carboplatin|
11996903|NCT00616031|Drug|nitroglycerin|
11996904|NCT00616031|Drug|paclitaxel|
11996905|NCT00616018|Drug|acetaminophen|4 g/day for 10 consecutive days
11996906|NCT00616005|Drug|Temodar and Irinotecan|Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide-day 1 of treatment cycle & every 24hrs thereafter for 5days w treatment cycles repeated every 6wks. Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. CPT-11-intravenously in fasting state over 90min. CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11-days 1, 8, 22, & 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. Dose of CPT-11 will be based on whether pt is receiving EIAEDs due to increased drug clearance produced by agents. For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.
11996907|NCT00615992|Drug|Tiotropium|
11996908|NCT00615979|Device|Miniature echo machine|Images captured and real-time and store-and-forward file transfers performed
11996909|NCT00615966|Drug|Diannexin|single dose, 200 µg/kg IV
11996910|NCT00615966|Drug|Placebo|Single dose, IV
11996911|NCT00615966|Drug|Diannexin|Single dose, 400 µg/kg IV
11996912|NCT00615940|Drug|WX-671|capsules taken per os once daily until progression or toxicity
11996913|NCT00615940|Drug|placebo|capsule taken per os once daily until progression or toxicity
11996914|NCT00615927|Drug|Imatinib Mesylate & Hydroxyurea|"Imatinib administered orally on daily. Imatinib is local irritant & must be taken in sitting position; mini of 2hrs should be allowed between last drug intake & going to bed. Imatinib doses 400mg/600mg administered once daily, whereas daily doses of 800mg/> administered as equally divided dose taken twice day. Dose for imatinib: Pts not receiving p450-inducing antiepileptic drugs: 400 mg/day. Pts receiving p450-inducing antiepileptic drugs: 500 mg twice day. It is recommended that pts take their prescribed imatinib mesylate at same time that they take their prescribed hydroxyurea, however, 30-60min interval between agents is acceptable if required for practical/other compliance issues.
~Hydroxyurea administered orally twice day. Dosing will begin on day 1 of cycle 1 & continue daily. Drug is approximately 80 percent bioavailable. Dose will be 500mg twice day for all pts."
11996915|NCT00615901|Drug|cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim|C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
11996916|NCT00615888|Procedure|Fast track patient management|no bowel washout, patient controlled epidural anesthesia, early enteral feeding
11996917|NCT00615888|Procedure|Traditional management|preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding
11996918|NCT00615875|Drug|naproxen|opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
11996919|NCT00615875|Drug|placebo|opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice
11996920|NCT00615862|Other|Observational study; no interventions|Validated questionnaires will be administered. Blood samples will be analyzed for levels of immune markers as well as cortisol. This is an observational study and patients will not undergo any treatment as part of study participation. Patients will not receive medications or other interventions if they participate in the study. Blood samples analyzed are from samples remaining in the hospital laboratory that were collected as part of routine patient care and destined to be discarded.
11996921|NCT00615849|Procedure|thoracoscopic surgery|stapled wedge resection of the lung mechanical pleural abrasion
11996922|NCT00615836|Drug|Desmopressin Melt|An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
11996923|NCT00615823|Drug|Atorvastatin|Patients were assigned to receive 10 mg of atorvastatin for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.
11996924|NCT00615823|Drug|Placebo|Patients were assigned to receive 10 mg of placebo for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.
11996925|NCT00615810|Drug|Atripla|Open label once daily for oral administration to be taken on an empty stomach
11996926|NCT00615810|Drug|Kivexa plus Sustiva|Open label once daily for oral administration
11996927|NCT00615797|Biological|Intravenous immunoglobulin|intravenous immunoglobulin 2g/kg total given over 2 days
11996928|NCT00615797|Drug|standard interventions penicillin VK and haloperidol|Penicillin V K 500mg 12hrly po or 250mg 6 hrly for 10 days IM penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG haloperidol 0,025mg/kg/day orally in divided doses gradually increasing to a maximum of 0,05mg/kg/day
11996929|NCT00615784|Drug|Bexarotene|Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
11996930|NCT00615771|Procedure|Day 3 embryo transfer|Standard of care
11996931|NCT00615771|Procedure|Day 2 embryo transfer|Embryos are transferred 1 day prior to standard of care
11996932|NCT00615758|Drug|Erlotinib|Erlotinib at the dose of 150 mg orally once a day continually until progression
11996933|NCT00615745|Drug|Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg|Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg as one tablet orally once daily taken on an empty stomach at bedtime.
11996934|NCT00615732|Procedure|Qigong|18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
11996935|NCT00615732|Procedure|exercise therapy|18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
11996936|NCT00615706|Other|No intervention|no intervention
11996937|NCT00615693|Drug|AEB071|
11996938|NCT00615667|Drug|tacrolimus (FK506)|Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
11996939|NCT00615654|Other|aquatic physical therapy|The aquatic physiotherapy program for the SG was applied twice a week, in groups of six to seven people, with sessions lasting 40 minutes, over a 12-week period. The Control Group protocol included maintenance of the individuals' medication therapy and absence of any physical activity during the study period.
11996940|NCT00615615|Drug|Levetiracetam|"high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg
~low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less"
11996941|NCT00615615|Drug|Placebo|Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy
11996942|NCT00615602|Drug|Docetaxel|Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
11996943|NCT00615602|Drug|Trastuzumab|Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months
11996944|NCT00615602|Drug|Epirubicin|Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
11996945|NCT00615602|Drug|Cyclophosphamide|Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
11996946|NCT00615602|Drug|5-fluoruracil|5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
11996947|NCT00615602|Drug|Granulocyte-colony stimulating growth factor|rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
11996948|NCT00615602|Drug|Trastuzumab|Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months
11996949|NCT00615589|Drug|Fludarabine/Busulfan x 4 days|"Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.
~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.
~The Fludarabine shall be administered prior to the Busulfan each day."
11996950|NCT00615589|Procedure|stem cell transplant|Allogeneic, peripheral blood stem cell transplant
11996951|NCT00615576|Drug|SB-656933|SB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily.
11996952|NCT00615576|Drug|Placebo|A placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily.
11996953|NCT00615563|Behavioral|NO BI Drug administered|
11996954|NCT00615550|Drug|progesterone|8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
11996955|NCT00615550|Drug|placebo|vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
11996956|NCT00615537|Procedure|Laser Ablation of Thyroid Nodule|Laser ablation using a laser generator, disposable fiberoptic laser fiber, cooling catheter and pump, will be performed under conscious sedation. Ultrasound will be used to localize masses. Local anesthesia will be administered both intradermally and subcutaneously. The laser applicator will be placed into the mass and laser energy will be delivered at 15W for 30-120 seconds. Real-time ultrasound monitoring of the ablation front will be used to ensure complete treatment of the target lesion. In larger masses applicators may be placed of the applicator into multiple locations. The number of locations will be determined by the treatment team, and based on lesion morphology, size, location, and accessibility.
11996957|NCT00615524|Drug|exemestane and pazopanib|
11996958|NCT00615511|Dietary Supplement|placebo pregnenolone|Sugar pill, taken twice a day
11996959|NCT00615511|Dietary Supplement|pregnenolone|500mg in tablet form taken orally twice a day
11996960|NCT00615472|Drug|Isoflurane|Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
11996961|NCT00615472|Drug|Remifentanil|Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min. These will be titrated as needed to maintain a standard blood pressure. Both infusions will be turned off at the end of the procedure. If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
11996962|NCT00615472|Drug|Propofol|Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min. These will be titrated as needed to maintain a standard blood pressure. Both infusions will be turned off at the end of the procedure. If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
11996963|NCT00615459|Drug|Indacaterol|Indacaterol 150 μg or 300 μg, delivered via SDDPI
11996964|NCT00615459|Drug|Tiotropium|Tiotropium 18 μg once daily delivered via inhalation device
11996965|NCT00615459|Drug|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
11996966|NCT00615446|Drug|SU011248; Gemcitabine|Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity
11996967|NCT00615433|Drug|Lurasidone|120mg/day
11996968|NCT00615433|Drug|Olanzapine|15mg/day
11996970|NCT00615433|Drug|Lurasidone 40 mg tablets|Lurasidone 40 mg tablets
11996971|NCT00615420|Dietary Supplement|manuka honey|Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
11996972|NCT00615420|Dietary Supplement|placebo gel|Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
11996973|NCT00615394|Procedure|intramyocardial bone marrow stem cells implantation|Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.
11996974|NCT00615381|Drug|Insulin|insulin infusion (0-10 U/hr) vs. 0.3 U/kg/hr and boluses (0-8 U) adjusted every 15 minutes during the intraoperative period to maintain intraoperative euglycemia (blood glucose levels 80-120 mg/dL)
11996975|NCT00615368|Drug|Epoetin alfa|1 (one) intravenously injection of 40.000 IU epoetin alfa 6 days before induction of experimental hypoglycemia.
11996976|NCT00615368|Drug|Isotonic NaCl (Placebo)|1 ml. of isotonic NaCl is intravenously injected 6 days before induction of experimental hypoglycaemia
11996977|NCT00615355|Radiation|UVB 311 nm radiation|UVB 311 nm radiation randomized to one half of the transplanted vitiligo lesion given 2 times a week for 3 months; the other half of the transplanted lesion remains UV-non-irradiated
11996978|NCT00615355|Device|UVB 311nm|Repeated UVB 311nm narrowband irradiation (24 exposures)
11996979|NCT00615316|Drug|Guaraná|Guaraná extract 75mg/day
11996980|NCT00615316|Drug|Placebo|Placebo 1tab/d
11996981|NCT00615303|Drug|Simethicone|2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day. The colonoscopic examination was recorded
11996982|NCT00615303|Drug|Placebo|2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day
11996983|NCT00615290|Drug|tipranavir|
11996984|NCT00615277|Dietary Supplement|Omega-3 fatty acids|600 mg EPA 120mg DHA daily, 16 weeks
11996985|NCT00615264|Drug|DiaPep277|1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
11996986|NCT00615264|Drug|Placebo|Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
11996987|NCT00615251|Drug|DR-2011|Progesterone vaginal ring for approximately 10 weeks
11996988|NCT00615251|Drug|Crinone 8%|progesterone vaginal gel for approximately 10 weeks
11996989|NCT00615238|Behavioral|Diet plus continuous bouts|Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week
11996990|NCT00615238|Behavioral|Diet plus short bouts|Patients consumed a 1200 kcal/d diet and were instructed to perform short 10 minutes bouts of aerobic exercise 4 times per week
11996991|NCT00615238|Behavioral|Diet plus moderate lifestyle activity|Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.
11996992|NCT00615225|Procedure|Muscle biopsy|Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery
11996993|NCT00615212|Drug|GSK376501|GSK376501 oral tablet will be available with dosing strengths of 75 milligrams administered once daily. Biconvex, It will be a round, white film-coated tablets with both plain sides and no identifying markings.
11996994|NCT00615212|Drug|Midazolam|Midazolam oral syrup will be available with a dose of 5 milligrams administered once daily. It will be a clear, red to purplish-red, cherry-flavored syrup.
11996995|NCT00615212|Drug|Rosiglitazone|Rosiglitazone oral tablet will be available with dosing strengths of 4 milligrams administered once daily. It will be a orange colored tablet debossed with SB on one side and 4 on the other.
11996996|NCT00615212|Drug|Flurbiprofen|Rosiglitazone oral tablet will be available with dosing strengths of 50 milligrams administered once daily. It will be a blue, oval, film coated tablet.
11996997|NCT00615199|Drug|CP-690,550|administration via oral route twice daily
11996998|NCT00615199|Drug|CP-690,550|administration via oral route twice daily
11996999|NCT00615199|Drug|CP-690,550|administration via oral route twice daily
11997000|NCT00615199|Drug|Placebo|administration via oral route twice daily
11997001|NCT00615186|Drug|Neuradiab + Radiotherapy + Temozolomide|"Prior Surgery
~Rickham Catheter placement 99mTc-DTPA Flow Study
~Neuradiab Dosimetry Study
~Neuradiab Therapeutic Dose Administration
~Radiation Therapy (XRT) + Temozolomide:
~XRT 5 days/week + temozolomide (75 mg/m2/day) over 6.5 weeks.
~Post-Radiation Temozolomide Therapy:
~Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment."
11997002|NCT00615186|Drug|Radiation Therapy + Temozolomide|"Prior Surgery: Gross total resection (< 1 cm. enhancing rim)
~Radiation Therapy (XRT) + Temozolomide:
~XRT 5 days/week + 42 days of temozolomide (75 mg/m2/day) over 6.5 weeks
~Post-Radiation Temozolomide Therapy:
~Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment."
11997003|NCT00615173|Drug|tacrolimus (FK506)|Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
11997004|NCT00615173|Drug|cyclophosphamide or azathioprine|Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.
11997005|NCT00615160|Drug|PTK787/ZK 222584|PTK-ZK capsules taken orally with a daily flat dose of 1250 mg
11997006|NCT00615160|Drug|Dacarbazine|Dacarbazine 850 mg/m² on day 1 q4w
11997007|NCT00615147|Procedure|CT pulmonary angiogram and d-dimer draw|A CT pulmonary angiogram and a d-dimer drawn within 24 hours.
11997008|NCT00615134|Drug|enfuvirtide [Fuzeon]|90mg sc bid
11997009|NCT00615134|Drug|Optimized background ARV therapy|As prescribed
11997010|NCT00615095|Other|self-administered questionnaire and blood draw|Epidemiologic data will be collected via a self-administered questionnaire which will be distributed to subjects by a member of the study staff. It should take less than fifteen minutes to complete, and subjects will have the options of completing it at the time of their blood-drawing or filling it out at home and mailing it back to the study staff.
11997011|NCT00615095|Other|self-administered questionnaire and blood draw|Epidemiologic data will be collected via a self-administered questionnaire which will be distributed to subjects by a member of the study staff. It should take less than fifteen minutes to complete, and subjects will have the options of completing it at the time of their blood-drawing or filling it out at home and mailing it back to the study staff.
11997012|NCT00615095|Other|health questionnaire, blood draw and skin exam|Numbers will be randomly selected from a pool of prefixes. Numbers will be screened by computer for being working, non-business, non-fax, and non-modem numbers. After establishing eligibility for the study, we will send the potential control a letter further explaining the purpose of the study and its requirements. An interviewer will then call to arrange an appointment. During the interview, the subject will sign informed consent, be given the public health questionnaire, have 30 ml of blood drawn, and undergo the skin examination of arms and back.
11997013|NCT00615082|Behavioral|Mindfulness-Based Stress Reduction|An 8-week course led by an experienced instructor in a group format of up to 15 people. Participants in the MBSR course learn mindfulness meditation techniques and simple yoga exercises such as stretching.
11997014|NCT00615082|Behavioral|Caregiver Education & Social Support|An 8-week course led by experienced instructors in a group format of up to 15 people. Participants in the CESS course learn about a variety of important issues related to elder care and receive social and emotional support in a group discussion format.
11997015|NCT00615069|Device|31 mm GORE EXCLUDER® AAA Endoprosthesis|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
11997016|NCT00615056|Drug|Bevacizumab (avastin)|Bevacizumab intravenous [IV] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
11997017|NCT00615056|Drug|FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])|Irinotecan (180 mg/m²) intravenous infusion [IV] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous [IV] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
11997018|NCT00615056|Drug|AG-013736 (axitinib)|Axitinib is given at a starting dose of 5 mg twice daily [BID] continuous dosing until disease progression, intolerance or withdrawal of consent.
11997019|NCT00615056|Drug|FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])|Oxaliplatin (85 mg/m²) intravenous infusion [IV] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
11997020|NCT00615056|Drug|AG-013736 (axitinib)|Axitinib is given at a starting dose of 5 mg twice daily [BID] continuous dosing until disease progression, intolerance or withdrawal of consent.
11997021|NCT00615056|Drug|FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])|Irinotecan (180 mg/m²) intravenous infusion [IV] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
11997022|NCT00615056|Drug|Bevacizumab (avastin)|Bevacizumab intravenous infusion [IV] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
11997023|NCT00615056|Drug|FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])|Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
11997024|NCT00615043|Procedure|Bladder biopsy|provision of bladder tissue via cystoscopic biopsy during planned TURBT
11997025|NCT00615030|Drug|Indacaterol|300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
11997026|NCT00615030|Drug|Salmeterol|50 µg twice daily delivered via dry powder inhaler (DPI)
11997027|NCT00615030|Drug|Placebo to Indacaterol|Placebo matching indacaterol was delivered via SDDPI.
11997028|NCT00615030|Drug|Placebo to Salmeterol|Placebo matching salmeterol was delivered via DPI
11997029|NCT00615017|Drug|AZD9773 (CytoFab)|intravenous infusions
11997030|NCT00615017|Other|Placebo|Placebo
11997031|NCT00614991|Drug|Raltegravir|400mg BID
11997032|NCT00614991|Drug|Fosamprenavir|1400mg BID, 700 mg BID or 1400 mg QD
11997033|NCT00614991|Drug|Ritonavir|100 mg BID or QD
11997034|NCT00614978|Drug|lapatinib and temozolomide|Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.
11997035|NCT00614965|Drug|Irinotecan|Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
11997036|NCT00614965|Drug|Cisplatin|Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
11997037|NCT00614965|Drug|Pemetrexed|Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles
11997038|NCT00614952|Device|PSG (polysomnography)|POLYSOMNOGRAPHY
11997039|NCT00614952|Other|PR (respiratory polygraphy)|respiratory polygraphy: level III of AASM
11997040|NCT00614939|Drug|Saxagliptin|2.5 mg once daily oral dose
11997041|NCT00614939|Drug|Placebo|Placebo
11997042|NCT00614926|Drug|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
11997085|NCT00614471|Drug|Entecavir|0.5mg po daily for 24 weeks
11997043|NCT00614926|Drug|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
11997044|NCT00614913|Radiation|Proton radiation therapy|A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.
11997045|NCT00614874|Drug|rosiglitazone|2mg, 4mg, 8mg
11997046|NCT00614861|Other|Non-cancer pain management survey|Non-cancer pain management survey
11997047|NCT00614848|Device|Endeavor drug eluting coronary stent|Zotarolimus coated coronary stent (10ug/mm)
11997048|NCT00614835|Drug|Docetaxel plus Gemcitabine|Gemcitabine 900 mg/m2 IV over 90 minutes day 1 Gemcitabine 900 mg/m2 IV over 90 minutes day 8 + Docetaxel 75 mg/m2 IVPB day 8 Dexamethasone 8 mg po bid days 7-9 GCSF 150 ug/m2 (round to nearest vial size: 350 ug or 480 ug) SQ days 9-15 Repeat every 21 days for total of 4 cycles
11997049|NCT00614822|Drug|Carboplatin, Pemetrexed and Bevacizumab|Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
11997050|NCT00614809|Drug|gefitinib|gefitinib 250mg qd until disease progression or unacceptable toxicity.
11997051|NCT00614796|Behavioral|Coach, using a stepcounter with exercise counseling|5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
11997052|NCT00614770|Procedure|standard of care colonoscopy|"Standard White Light Colonoscopy
~one exam per patient"
11997053|NCT00614770|Procedure|colonoscopy|"Narrow Band Imaging Colonoscopy
~one exam per patient"
11997054|NCT00614770|Procedure|standard of care colonoscopy|"High Definition White Light Colonoscopy
~one exam per patient"
11997055|NCT00614757|Drug|N-acetylcysteine 20% 4ml|N-acetylcysteine 20% 4ml
11997056|NCT00614757|Drug|N-acetylcysteine 20% in 4 ml|N-acetylcysteine 20% in 4 ml
11997057|NCT00614744|Procedure|Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
11997058|NCT00614744|Procedure|Normothermic Control|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
11997059|NCT00614731|Biological|KLH carrier-protein|KLH carrier-protein vaccination containing no other protein or antibodies
11997060|NCT00614705|Drug|PH-797804|6 mg dose in oral capsule form, once daily for 28 days
11997061|NCT00614705|Drug|Placebo|oral capsule form, once daily for 28 days
11997062|NCT00614679|Drug|catheter lock solution consisting of N-acetylcystein, tigecycline and heparin|N-acetylcystein 80 mg/ml, tigecycline 1 mg/ml, and heparin 2000 units/ml. This will be a 5 ml catheter lock solution
11997063|NCT00614666|Drug|nikkomycin Z|"Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.
~50 mg BID (n=8) vs placebo capsule BID (n=2)
~250 mg BID (n=8) vs Placebo capsule BID (n=2)
~500 mg BID (n=8) vs Placebo capsule BID (n=2)
~750 mg TID (n=8) vs Placebo capsule TID (n=2)
~At least 4 subjects complete lower dose before randomization includes next higher dose, thus there are 4 arms for active intervention and corresponding placebos.
~Stage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization."
11997064|NCT00614653|Drug|Bevacizumab|5 mg/kg IV Over 90 Minutes Every 2 Weeks
11997065|NCT00614653|Drug|Erlotinib|100 mg by mouth Once Daily on days with radiation.
11997066|NCT00614653|Drug|Capecitabine|400 mg/m^2 PO Twice Daily on days with radiation.
11997067|NCT00614653|Radiation|Radiation Therapy|Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy
11997068|NCT00614640|Biological|DermaVir patch|DNA Vaccine
11997069|NCT00614640|Biological|Placebo patch|10% dextrose (D-glucose) solution
11997070|NCT00614614|Biological|GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)|One dose in the booster phase as intramuscular injection
11997071|NCT00614614|Biological|GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)|Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
11997072|NCT00614614|Biological|Infanrix®|One dose as intramuscular injection
11997073|NCT00614614|Biological|ActHIB®|Three doses in the priming phase as intramuscular injection
11997074|NCT00614614|Biological|Pediarix®|Three doses in the priming phase as intramuscular injection
11997075|NCT00614601|Biological|HyperAcute(R)-Pancreatic Cancer Vaccine|100 million vaccine cells will be injected intradermally for up to 14 vaccinations over approximately 8 months
11997076|NCT00614588|Device|Body temperature thermometers|Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.
11997077|NCT00614562|Device|Neurally adjusted ventilatory assist (NAVA)|NAVA for 72 hours
11997078|NCT00614536|Drug|Rabeprazole Sodium|10mg - 20mg tablet once or twice daily for 12weeks
11997079|NCT00614523|Drug|Placebo|Placebo is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
11997080|NCT00614523|Biological|Romiplostim|Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
11997081|NCT00614510|Device|CardioWest temporary Total Artificial Heart (TAH-t)|The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external console connected by drivelines.
11997082|NCT00614484|Radiation|Proton Radiation Therapy|A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
11997083|NCT00614484|Drug|Taxol|200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
11997084|NCT00614484|Drug|Carboplatin|AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.
11997086|NCT00614471|Drug|Entecavir|0.5mg po daily from week 13 to week 36
11997087|NCT00614471|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc/week for 48 weeks
11997088|NCT00614471|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc/week from week 21 to week 68
11997089|NCT00614458|Drug|Raltegravir; valproic acid|raltegravir 400mg po BID; valproic acid 1000mg - 2000mg daily
11997090|NCT00614445|Drug|doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg|up to 4 tablets daily, titrated according to the protocol
11997091|NCT00614445|Drug|Placebo|2 to 4 tablets daily titrated according to the protocol
11997092|NCT00614419|Device|Prolene Polypropylene Mesh|The Lichtenstein tension-free hernioplasty consists of a swatch of polypropylene mesh, partway slit 1 cm from its inferior edge to accommodate the spermatic cord. The mesh is sutured circumferentially to the internal oblique abdominal muscle, the rectus sheath and the shelving edge of the inguinal ligament. The tails of the mesh are drawn around the cord and the inferior edge of each tail is sutured to the inguinal ligament. In case of direct hernias, no effort is made to repair the hernia itself. In indirect hernias the sac is excised, except for sliding hernias. The polypropylene mesh group: in this group of patients the polypropylene mesh will be fixed by the above mentioned sutures in Prolene 3/0.
11997093|NCT00614419|Device|Surgisis Inguinal Hernia Matrix|The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0.
11997094|NCT00614406|Drug|Celebrex|One 400mg tablet daily.
11997095|NCT00614406|Drug|Placebo|One tablet daily.
11997096|NCT00614393|Biological|dalotuzumab|IV infusion
11997097|NCT00614393|Drug|irinotecan hydrochloride|IV infusion
11997098|NCT00614393|Biological|cetuximab|IV infusion
11997099|NCT00614393|Drug|placebo|IV infusion
11997100|NCT00614380|Drug|telmisartan/amlodipine 40/5 mg fixed combination|
11997101|NCT00614380|Drug|telmisartan/amlodipine 80/5 mg fixed combination|
11997102|NCT00614354|Drug|99mTc-glucarate solution|Patients will receive a single 22 - 27 mCi bolus intravenous dose of 99mTc-glucarate solution, as soon as possible after their arrival in the emergency department or the chest pain center
11997103|NCT00614341|Device|MedRelief SE 55|4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase
11997104|NCT00614328|Drug|Naltrexone, Baclofen, Placebo and Behavior Therapy|Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
11997105|NCT00614315|Device|FLAIR™ Endovascular Stent Graft|The FLAIR™ Endovascular Stent Graft is designed to treat venous anastomotic stenoses of AV access grafts, providing both structural support of the site following angioplasty (stent), and a barrier to locally recurrent flow-limiting neointimal tissue growth (covering/graft).
11997106|NCT00614302|Drug|TPV|
11997107|NCT00614289|Device|Epikeia Coatings|Topical skin coating
11997108|NCT00614276|Behavioral|Focus Group|To evaluate a multimedia intervention program for women with cancer-related sexual dysfunction.
11997109|NCT00614276|Behavioral|TENDRILS|Tendrils: A Sexual Renewal Program for Women Surviving Cancer - a website designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems.
11997110|NCT00614276|Behavioral|Questionnaires|The questionnaires ask about your background (such as age, education, relationships), your cancer diagnosis and treatment, and the quality of your life in terms of your health, your general emotions, and your sexual function. The questionnaires take about 30-45 minutes to complete.
11997111|NCT00614276|Behavioral|Sexual Counseling Sessions|Attend 3 sexual counseling sessions at M. D. Anderson.
11997112|NCT00614250|Drug|AVE0657|capsules once a day at bedtime
11997113|NCT00614250|Drug|placebo|capsules once a day at bedtime
11997114|NCT00614224|Behavioral|treadmill exercise training|3 months (3 times/week) progressive graded aerobic treadmill training with a duration of 10-45 min per training session
11997115|NCT00614211|Procedure|Total Abdominal Radical Hysterectomy|In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised.
11997116|NCT00614211|Procedure|Total Laparoscopic or Robotic Radical Hysterectomy|In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised.
11997117|NCT00614198|Other|Gluten- and casein-free diet|Removal of foods containing gluten (cereal produce) and casein (dairy produce)
11997118|NCT00614172|Radiation|Proton radiation therapy|Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.
11997119|NCT00614159|Drug|Ketamine|Weight based dosage for Peds subjects, used for duration of the endoscopy.
11997120|NCT00614159|Drug|Propofol|Weight based dosage for Peds subjects, used for duration of the endoscopy.
11997121|NCT00614146|Device|MARS device|10 treatments with the MARS system during the first three weeks after enrollment of 5-8 hours each.
11997122|NCT00614146|Procedure|Standard medical therapy|Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol
11997123|NCT00614146|Procedure|Standard medical therapy|Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol
11997124|NCT00614133|Other|Intravenous nutrition with glucose and amino acids|Glucose and amino acids intravenously starting 20 hours before the operation until the second postoperative day. Glucose provides 50% and amino acids 20% of each patient's measured resting energy expenditure.
11997125|NCT00614133|Other|Intravenous nutrition with glucose and amino acids.|Glucose and amino acids intravenously starting with surgical skin incision until the second postoperative day. Glucose provides 50% and amino acids 20% of each patient's measured resting energy expenditure.
11997126|NCT00614120|Drug|liraglutide|0.6 mg/day, s.c. (under the skin) injection
11997127|NCT00614120|Drug|placebo|Glimepiride placebo, capsules
11997128|NCT00614120|Drug|liraglutide|1.2 mg/day, s.c. (under the skin) injection
11997129|NCT00614120|Drug|liraglutide|1.8 mg/day, s.c. (under the skin) injection
11997130|NCT00614120|Drug|glimepiride|Capsules, 4.0 mg/day
11997131|NCT00614120|Drug|metformin|Tablets, 1.5-2.0 g/day
11997132|NCT00614120|Drug|placebo|Liraglutide placebo, s.c. (under the skin) injection
11997133|NCT00614081|Device|Contrast-enhanced dynamic MRI|
11997134|NCT00614068|Behavioral|Trauma-focused cognitive behavioral therapy (TF-CBT)|TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.
11997135|NCT00614068|Behavioral|Treatment as usual (TAU)|TAU outpatient sessions will include routine community care and nontrauma-focused therapy.
11997136|NCT00614055|Drug|insulin degludec/insulin aspart|Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
11997137|NCT00614055|Drug|insulin degludec/insulin aspart|Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
11997138|NCT00614055|Drug|insulin glargine|Treat-to-target dose titration scheme, injection s.c., once daily
11997139|NCT00614055|Drug|metformin|Tablets, 1500-2000 mg/day
11997140|NCT00614042|Drug|TRU-016 (anti-CD37 protein therapeutic)|TRU-016 administered via IV infusion weekly for 8 weeks and then monthly
11997141|NCT00614029|Device|Sumatriptan (via Intraject System)|0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
11997142|NCT00614016|Drug|Sodium ST20|single administration of oral dosage form
11997143|NCT00614003|Behavioral|Decision support skills building Intervention|Decision support skills
11997144|NCT00613964|Drug|Carperitide heart failure therapy|carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)
11997145|NCT00613964|Drug|Standard heart failure therapy|Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis
11997146|NCT00613951|Drug|insulin degludec/insulin aspart|Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily
11997147|NCT00613951|Drug|insulin degludec/insulin aspart|Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily
11997148|NCT00613951|Drug|biphasic insulin aspart|Treat-to-target dose titration scheme, injection s.c., twice daily
11997149|NCT00613951|Drug|metformin|Tablets, 1500-2000 mg/daily
11997150|NCT00613938|Drug|Tapentadol (CG5503)|50mg capsule q4-6 hrs for 3 days
11997151|NCT00613938|Drug|Tapentadol (CG5503)|75mg capsule q4-6 hrs for 3 days
11997152|NCT00613938|Drug|oxycodone|10mg capsule q4-6 hrs for 3 days
11997153|NCT00613938|Drug|placebo|1 capsule q4-6 hrs for 3 days
11997154|NCT00613925|Device|Pipelle de Cornier|A flexible suction cannula 23.5 cm in length with an inner diameter of 2.6 mm and an outer diameter of 3.1 mm. It has a 2.4mm diameter opening on the distal end, on one side of the cannula. It is a disposable polypropylene sheath with an inner plunger and is used for blind endometrial biopsy.
11997155|NCT00613925|Device|Explora curette|The curette has an outer diameter of 3.0 mm and is slightly more rigid. This cannula has a sharp Randall-type cutting edge on the distal end, on one side of the cannula.
11997156|NCT00613912|Other|Magnetic Resonance Imaging|"Morphological sequences
~Arterial Spin Labelling (Perfusion)
~Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter"
11997157|NCT00613899|Other|telesurveillance|A telesurveillance program for cough assistance will be approched by the use of an in-exoflator device. Measurement of oxygen saturation (SpO2) will be performed by a Nonin 9500 oxymeter (Minneapolis Plymouth USA).
11997158|NCT00613886|Device|Programmable Shunt Insertion (Codman, Medtronic)|Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter. Patient will be brought to operating room suite where general anesthesia is induced. Patient will be placed with a small roll on shoulder, supine, on the operating room table. Patient's head will be turned with the parietal area uppermost in the field. Patient will be prepared and draped in the usual sterile fashion. Site prep includes parietooccipital area, side of neck, chest, and entire abdomen. Ventricular catheter placed and then attached to shunt valve. Catheter is then fitted over grooved blue burr hole guide. Excess catheter pulled down to pull valve into pocket on the skull. Sterile dressings applied.
11997159|NCT00613886|Behavioral|Assessments in physical therapy, occupational therapy, and speech therapy|Follow-up testing to be administered by trained Physician Assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, Mini-Mental Status Exam, 9-hole Grooved Pegboard, Motor Visual Perception Test (MVPT), Modified Rankin Score (MRS)
11997160|NCT00613873|Procedure|Colonoscopy and Questionnaire|Pt is asked to complete attitude and belief questionnaire then have a Colonoscopy. Then within 6 weeks post colonoscopy a final telephone interview.
11997161|NCT00613860|Device|Zephyr endobronchial valve|Endobronchial valve system to redirect the airflow within the bronchial system
11997162|NCT00613847|Radiation|PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab|Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.
11997163|NCT00613847|Radiation|PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab|Once safety and feasibility has been established in this group, then enrollment to the HER2 1+ cohort will commence. Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.
11997164|NCT00613834|Drug|Lidocaine|5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
11997165|NCT00613834|Drug|Sterile Saline|5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
11997166|NCT00613821|Drug|Lidocaine|5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
11997167|NCT00613821|Drug|Lidocaine|Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
11997168|NCT00613808|Drug|Nitric Oxide 200ppm Group B|200 ppm, 8hrs / day for 6 weeks
11997169|NCT00613795|Dietary Supplement|Lactobacillus GG|Every 12 hours, the contents of a single capsule containing Lactobacillus GG will be suspended in 3 ml of water-soluble jelly. The suspension will be applied to the oropharyngeal mucosa via sterile syringe. The contents of a second capsule will be suspended in 10 ml of sterile water and pushed through the NG tub followed by 10 mL of air to ensure complete administration.
11997170|NCT00613795|Dietary Supplement|placebo|Every 12 hours, the contents of a single identical placebo capsule containing the inert plant carbohydrate inulin will be suspended in 3 ml of water-soluble jelly. This suspension will be applied to the oropharyngeal mucosa via sterile syringe. The contents of a second placebo capsule will be suspended in 10 ml of sterile water and pushed through eh NG tube followed by 10 mL of air to ensure complete administration
11997171|NCT00613782|Drug|Reandron 1000|1000mg at 0,6,18,30 weeks
11997172|NCT00613782|Drug|placebo|placebo injection 0,6.18.30 weeks
11997173|NCT00613769|Drug|trimethoprim-sulfamethoxazole + metronidazole|trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.
11997174|NCT00613769|Drug|cefuroxime and metronidazole|cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
11997175|NCT00613743|Drug|mouth wash with morphine|morphine solution 0.2% concentration; 15ml per unit mouthwash 6 time à day
11997176|NCT00613743|Drug|placebo|placebo solution Quinine diHCl 0.3% at 50 mg/15 ml mouthwash 6 time/day
11997177|NCT00613730|Drug|Gemcitabine|Intravenous administration
11997178|NCT00613730|Drug|panitumumab|Intravenous administration
11997179|NCT00613717|Dietary Supplement|folic acid + iron prenatally, vits A & D + iron postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D."
11997180|NCT00613717|Dietary Supplement|folic acid + iron prenatally, vitamins A & D postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D."
11997181|NCT00613717|Dietary Supplement|folic acid prenatally, vitamins A & D + iron postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D."
11997182|NCT00613717|Dietary Supplement|folic acid prenatally, vitamins A & D postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D."
11997183|NCT00613691|Drug|SPI-1620|SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds
11997184|NCT00613678|Behavioral|Activity Strategy Training|The AST component will involve training in specific behavioral and environmental strategies to facilitate performance in daily activities and routines. The activity strategy training group sessions will use education, group discussion, and demonstration and practice of techniques to facilitate activity performance. Homework assignments will be given after many of the sessions to practice and reinforce concepts learned.
11997185|NCT00613678|Behavioral|Education|The health education program is based on educational materials from the Arthritis Foundation.
11997186|NCT00613665|Biological|helicobacter pylori vaccine|Experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
11997187|NCT00613665|Biological|helicobacter pylori vaccine|Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
11997188|NCT00613665|Biological|helicobacter pylori vaccine|Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
11997189|NCT00613665|Biological|helicobacter pylori vaccine|Eight subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
11997190|NCT00613665|Biological|Placebo|Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly
11997191|NCT00613665|Biological|helicobacter pylori vaccine|Nine subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
11997192|NCT00613665|Biological|helicobacter pylori vaccine|Ten subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
11997193|NCT00613652|Drug|AZD4877|10 mg IV (3 weeks treatment 1 week rest)
11997194|NCT00613626|Drug|Cisplatin|Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
11997195|NCT00613626|Drug|Etoposide|Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
11997196|NCT00613626|Drug|Placebo|Matched placebo oral daily
11997197|NCT00613626|Drug|ZD6474|ZD6474 100mg oral daily to be continued for the duration of the study.
11997198|NCT00613613|Drug|fenofibrate|Fenofibrate 145mg tablets once daily for 4 weeks
11997199|NCT00613613|Drug|fenofibrate|Fenofibrate 145mg tablets once daily for 4 weeks
11997200|NCT00613600|Dietary Supplement|Glucomannan|Two 665 mg capsules of glucomannan three times a day for 8 weeks
11997201|NCT00613600|Dietary Supplement|Inert microcrystalline cellulose|Two capsules of inert microcrystalline cellulose three times a day for eight weeks
11997404|NCT00612079|Drug|Sertindole|oral 3 x 4mg
11997202|NCT00613574|Drug|tiotropium-bromide|Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care
11997203|NCT00613561|Drug|Fludarabine, Busulfan, and Anti-Thymocyte Globulin|Patients on this study will receive 5 days of Fludarabine, 1 day of Busulfan Test Dose, 2 Days of Busulfan Regimen Dose, and 4 days of Anti-Thymocyte Globulin
11997204|NCT00613548|Procedure|CABG alone|CABG alone
11997205|NCT00613548|Procedure|CABG + Mitral repair|CABG + Mitral repair
11997206|NCT00613535|Device|Mechanical debridement|Mechanical shaver will be used to remove large chondral flaps and loose fragments
11997207|NCT00613535|Device|Paragon T2|Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
11997208|NCT00613535|Procedure|Lavage debridement|Remove loose chondral fragments
11997209|NCT00613535|Device|Mechanical Debridement|Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
11997210|NCT00613535|Device|RF- based Debridement|Use of debridement device to remove large fragments followed by use of RF-based debridement to smooth the base of the shoulder of the tear.
11997211|NCT00613522|Other|polygraphic study|"Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2.
~Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).
~Controls will be evaluated at 3 months using a phone interview"
11997212|NCT00613509|Biological|ALVAC(2) Melanoma multi-antigen therapeutic vaccine|0.5 mL, 2 cycles
11997213|NCT00613509|Biological|Intron A, Interferon alpha -2b|0.5 mL, 5 times per week for 4 weeks
11997214|NCT00613496|Drug|irbesartan|Irbesartan-tablet (150 mg) 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8 if no contraindication for up titration (investigator will decide on the basis of creatinin, urea and potassium after taking a blood sample) for 9 weeks.
11997215|NCT00613496|Drug|placebo|Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.
11997216|NCT00613470|Drug|citalopram and escitalopram|"escitalopram tablets starting at 10 mg, increase to 20 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5.
~citalopram tablet or solution starting at 2o mg, increase to 40 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5."
11997217|NCT00613457|Drug|dexamethasone|10 mg/sqm/day from for 21 days
11997218|NCT00613457|Drug|asparaginase|native E-coli Asparaginase 5,000 IU/sqm x 8 doses
11997219|NCT00613457|Drug|Asparaginase|native E-Coli Asparaginase 10,000 IU/sqm x 4 doses
11997220|NCT00613457|Drug|cyclophosphamide|1,000 mg/sqm i.v. 2 doses in Induction phase 1000 mg/sqm i.v. 1 dose in Protocoll II 500 mg/sqm i.v. 1 dose in protocol III
11997221|NCT00613457|Drug|cytarabine|75 mg/sqm i.v.or s.c. 4 doses/week for 4 weeks in Induction phase 75 mg/sqm i.v.or s.c. 4 doses/week for 2 weeks in Protocol II and III
11997222|NCT00613457|Drug|daunorubicin|30 mg/sqm i.v. 4 doses in Induction phase
11997223|NCT00613457|Drug|doxorubicin|30 mg/sqm i.v. x 4 doses in Protocol II and III
11997224|NCT00613457|Drug|Etoposide|100 mg/sqm i.v. for 3 doses in HR block 3
11997225|NCT00613457|Drug|Ifosfamide|800 mg/sqm i.v.q12h x 5 in HR block 2
11997226|NCT00613457|Drug|mercaptopurine|60 mg/sqm p.o. c 28 days in Induction phase 60 mg/sqm p.o. x 56 days in Protocol M 50 mg/sqm daily in Maintenance phase
11997227|NCT00613457|Drug|Methotrexate|by age i.t. in Induction/Protocol M/Protocol II/Protocol III/HR Blocks and maintenance
11997228|NCT00613457|Drug|prednisone|60 mg/sqm daily p.o. for 28 days then tapered in Induction phase
11997229|NCT00613457|Drug|thioguanine|60 mg/sqm p.o. x 14 days in Protocol II and Protocol III
11997230|NCT00613457|Drug|Vincristine|1.5 mg/sqm i.v. x 4 doses in Induction phase and Protocol II 1.5 mg/sqm i.v. x 2 doses in Protocol III and HR block 1
11997231|NCT00613457|Drug|Vindesine|3 mg/sqm i.v. x 2 doses in HR block 2
11997232|NCT00613444|Device|LumaCare LC-122M non-coherent light source|Subjects will receive a series of up to 6 treatment sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, light treatment parameters will be within the guidelines normally used clinically for red-light non-coherrent light sources, and thus fluences used will not exceed 75 J/cm2.
11997233|NCT00613431|Drug|CS8080|CS-8080 tablets will be administered once daily at doses of 1, 3, 10, 20, 50 and 100 mg.
11997234|NCT00613431|Drug|Placebo|Some subjects will receive matching placebo instead of CS-8080.
11997235|NCT00613418|Device|IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System|Interwoven, self-expanding nitinol stent system, including delivery system and stent
11997236|NCT00613405|Other|Stress + cue exposure|Trier Social Stress Task(TSST): subject is asked to give a talk and perform a math task in front of an audience, follwed by neutral and marijuana cue exposure.
11997237|NCT00613405|Other|No stress + cue exposure|Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
11997238|NCT00613392|Dietary Supplement|powdered antioxidant|one vial mixed with water every day orally or through enteral tube
11997239|NCT00613392|Dietary Supplement|powdered cornstarch placebo|one vial mix with water and administer orally or via enteral tube
11997240|NCT00613379|Drug|PRO 140|10 mg/kg PRO 140, one IV dose (N=10)
11997241|NCT00613379|Drug|PRO 140|5 mg/kg PRO 140, one IV dose (N=10)
11997242|NCT00613379|Drug|Placebo|PBO, one IV dose (N=10)
11997243|NCT00613366|Drug|Misoprostol|Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
11997244|NCT00613366|Dietary Supplement|Magnesium Oxide|Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
11997245|NCT00613353|Other|Behavioral|Participants will be asked to wear an accelerometer
11997246|NCT00613340|Procedure|Cervical medial branch blocks|Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
11997247|NCT00613340|Procedure|Cervical medial branch blocks|Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
11997248|NCT00613327|Drug|Oxybutynin chloride OROS|Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day.
11997249|NCT00613288|Drug|Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo|"The trial is a double blinded, randomised cross-over study of 4 x 2 days with an interval of 1 month in between. 12 healthy young male participants will receive the GnRH-agonist leuprorelide 7,5 mg s.c. 3 weeks before examination on 3 occasions, and a fourth day without intervention.
~The four days will include treatment on the examination day, Day 1 with:
~Placebo (hypogonadism after leuprorelide injection)
~Testosterone gel 50 mg applicated in the morning at 06.00 am (physiologic substitution - after leuprorelide injection).
~Testosterone gel 150 mg applicated in the morning at 06.00 am (supra-physiologic substitution - after leuprorelide injection).
~No treatment."
11997250|NCT00613275|Other|patient Navigation|Assigning a patient navigator to patients with abnormal breast and cervical cancer screening results at one of 6 affiliated community health centers
11997251|NCT00613262|Other|Narrow Band Imaging|Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time
11997252|NCT00613249|Drug|Dapivirine Gel 4750, 0.05%, 2.5g|intravaginal gel, dosed daily
11997253|NCT00613249|Drug|Dapivirine Gel 4789, 0.05%, 2.5g|intravaginal gel, dosed daily
11997254|NCT00613249|Drug|HEC-based Placebo Gel|intravaginal gel, dosed daily
11997255|NCT00613223|Drug|Vandetanib and Etoposide|Vandetanib will be given orally once day. Swallow tablet with 240 ml of non-carbonated water. Initial dose is 100 mg/day for stratum 1 & 200 mg/day for stratum 2. Etoposide will be taken by mouth in capsule form at a flat dose of 50 mg/day for 1st 21 days of 28-day cycle. You will not take etoposide for following 7 days of the cycle.
11997256|NCT00613197|Drug|Epanova|4g/day in divided doses
11997257|NCT00613184|Device|Nylon Flocked swab (Nasal secretion sampling)|Nasal Aspirate Nylon Flocked swab
11997258|NCT00613184|Device|Nylon Flocked swab (Nasal secretion sampling)|Nylon flocked swab Nasal Wash
11997259|NCT00613171|Drug|STI571|STI571 tablets taken orally once a day
11997260|NCT00613145|Drug|Capecitabine and Sorafenib|"During Cycle 1, patients will receive capecitabine alone for the first 7 days (Cohort A will receive 750 mg/m2 of capecitabine twice daily). For Days 8-14 of Cycle 1, patients will receive capecitabine (750 mg/m2 twice daily for Cohort A) combined with sorafenib (400 mg twice daily); on Days 15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily). Beginning with Day 1 of Cycle 2 and all treatment cycles thereafter, patients will be dosed as follows:
~Cohort A will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 750 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle."
11997261|NCT00613145|Drug|Capecitabine and Sorafenib|During Cycle 1, patients will receive capecitabine alone for the first 7 days Cohort B will receive 1000 mg/m2 of capecitabine twice daily for the first 7 days of Cycle 1). For Days 8-14 of Cycle 1, patients will receive capecitabine (1000 mg/m2 twice daily for Cohort B) combined with sorafenib (400 mg twice daily for both cohorts); on Days 15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily). Beginning with Day 1 of Cycle 2 and all treatment cycles thereafter, patients will be dosed as follows: Cohort B will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 1000 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle.
11997262|NCT00613132|Drug|Gleevec, RAD001, and Hydroxyurea|Dose of Gleevec will be 400 mg in 1st cohort & will be increased to 600 mg po/day & then to 400 mg bid in successive cohorts. Prescribed dose should be administered orally, w large glass of water. Pts should not eat large or high fat meal within 1 hour before or after gleevec dosing. Doses of 600 mg or less should be administered once daily, whereas doses greater than 600 mg should be administered as equal doses twice day. It is recommended that pts take their prescribed Gleevec at same time that they take their prescribed RAD001 & hydroxyurea, however, 30-60 minute interval between agents is acceptable if required for practical or other compliance issues.
11997263|NCT00613106|Drug|HZT-501|Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
11997264|NCT00613106|Drug|Ibuprofen|Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks
11997265|NCT00613093|Drug|Temodar and O6-Benzylguanine (BG)|"Objectives of study are to define role of BG in restoring Temodar sensitivity in patients with Temodar-resistant malignant glioma and to further define the toxicity of combination therapy using Temodar + BG. 2 separate strata accrued independently of each other: Stratum 1-patients with glioblastoma multiforme (GBM). Stratum 2-patients with anaplastic glioma (AG).
~BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24 hours. Temodar 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle."
11997266|NCT00613080|Drug|capecitabine|1650 mg/m^2/day orally 5 days/week during radiotherapy.
11997267|NCT00613080|Drug|oxaliplatin|
11997268|NCT00613080|Procedure|resection|All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.
11997269|NCT00613080|Radiation|radiation therapy|Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx
11997270|NCT00613080|Drug|FOLFOX|"Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m^2, IV over 2 hours, day 1.
~Leucovorin 400 mg/m^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m^2, IV continuous infusion over 46 hours, day 1."
11997271|NCT00613067|Drug|escitalopram|"Start with escitalopram 10mg
~According to patient's symptoms, stay on 10mg or increase up to 20mg
~Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages
~Length of washout period will be at least 2 weeks for any psychotropic drugs"
11997310|NCT00612716|Drug|busulfan|For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.
11997311|NCT00612716|Drug|cyclophosphamide|Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.
11997312|NCT00612716|Biological|Stem cell infusion|Infused on Day 0
11997313|NCT00612716|Radiation|Total body irradiation|165 cGy morning and evening on days -4 through -1.
11997314|NCT00612703|Drug|ARQ 197|Treatment with ARQ 197 in combination with erlotinib
11997272|NCT00613054|Drug|Zactima, Gleevec, Hydroxyurea|"Pts will start treatment on day 1 of cycle 1 w Zactima, imatinib mesylate & hydroxyurea. All 3 agents administered in continuous daily, oral manner. Imatinib mesylate dose 400 mg/day for pts not on EIAEDs & 1000 mg/day for pts on EIAEDs based on previous studies demonstrating that pts on EIAEDs require significantly higher doses of imatinib mesylate & that such doses are safe & well tolerated. Dose of hydroxyurea 500 mg twice day. Dose level of Zactima will be increased in successive cohorts of pts as described below.
~Cohorts of 3-6 pts will accrue at each dose level until MTD is defined. Each cohort will consist of a mini of 3 newly enrolled pts. Intra-patient dose escalation is not permitted. Cohorts may be expanded at any dose level for further elaboration of safety & pharmacokinetic parameters as required.
~Treatment cycle is defined as daily administration of Zactima + imatinib mesylate & hydroxyurea for 28 days for purpose of scheduling evaluations."
11997273|NCT00613041|Procedure|CT Scan|All patients will undergo serial CT scans after 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months as is standard care. Nodules are to be scanned at 2.5mm collimation / 1.25 mm reconstruction. This resolution is necessary for volume measurements of nodules less than 1cm in diameter.
11997274|NCT00613028|Drug|Temo + Avastin|Patients have progressed/had gr3/> toxicity related to etoposide, with no had progression/gr 3/> toxicity related to temozolomide, will only be considered for bevacizumab and temozolomide. Bevacizumab intravenously at dose 10mg/kg every other wk. For patients on bevacizumab and temozolomide, temozolomide administered on continuous dosing schedule at 50mg/m2/day.
11997275|NCT00613028|Drug|VP-16 + Avastin|Patients have progressed/had gr3/> toxicity related to temozolomide, but have not progressed/gr3/> toxicity related to etoposide,considered only for bevacizumab and etoposide. Bevacizumab intravenously at dose 10mg/kg every other wk. Patients on bevacizumab and etoposide, etoposide once daily at 50mg/m2/day first 21 days of each 28-day cycle.
11997276|NCT00613015|Drug|Guanfacine|
11997277|NCT00613015|Drug|Modafinil|
11997278|NCT00613015|Drug|Placebo|
11997279|NCT00613002|Drug|testosterone gel|once daily transdermal testosterone gel, 300 mcg
11997280|NCT00613002|Drug|placebo gel|once daily transdermal placebo gel
11997281|NCT00612989|Drug|Temodar and O6-Benzylguanine|"O6-BG 120mg/m2 administered intravenously over 1 hr followed by continuous infusion of O6-BG at 30 mg/m2/day for 5 consecutive days. Every 48 hrs repeat dose of 120 mg/m2 over 1 hr administered for total of 3 doses.
~Temodar administered orally, in fasting state within 60 minutes of end of 1st 1-hr infusion of O6-BG & then every 24 hrs during continuous infusion of O6-BG. Temodar administered on day 1 of treatment cycle & every 24 hrs thereafter for 5 days with treatment cycles repeated every 28 days.
~Pts must fast for minimum of 1 hr prior to administration of each dose of Temodar & continue fasting 2 hrs after administration of each Temodar dose."
11997282|NCT00612963|Drug|Frio Oral Rinse|Prescription Mouth Rinse
11997283|NCT00612950|Drug|glucagon-like peptide-1,|GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
11997284|NCT00612950|Drug|glucose dependent insulinotropic polypeptide|continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
11997285|NCT00612950|Drug|Saline|continuous infusion of Saline for 120 min
11997286|NCT00612924|Device|Anaconda Stent Graft System|Endovascular device
11997287|NCT00612924|Device|Anaconda ONE-LOK Stent Graft System|Endovascular device
11997288|NCT00612911|Other|Cell therapy|bone marrow mononuclear cell
11997289|NCT00612898|Drug|apricitabine|800mg BID apricitabine orally for 48 weeks
11997290|NCT00612898|Drug|lamivudine|150mg BID lamivudine orally for 48 weeks
11997291|NCT00612872|Drug|[123I]CLINDE|Subjects will be injected with up to 5 mCi and not to exceed 5.5 (not >10% of 5 mCi limit) of 123-I CLINDE followed by serial SPECT imaging.
11997292|NCT00612859|Drug|levetiracetam|
11997293|NCT00612846|Procedure|Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy|Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
11997294|NCT00612846|Procedure|Laparoscopic bile duct exploration during cholecystectomy|Laparoscopic bile duct exploration during cholecystectomy
11997295|NCT00612833|Procedure|Vasectomy occlusion techniques|Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
11997296|NCT00612820|Drug|GSK256066|200mcg bd,
11997297|NCT00612820|Drug|fluticasone propionate|200mcg od,100mcg bd
11997298|NCT00612807|Behavioral|Weekly marital therapy|Weekly marital therapy for 6 months.
11997299|NCT00612807|Drug|As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.|"Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002).
~SSRIs (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine)
~SNRIs (e.g., venlafaxine)
~Bupropion SR (achieve dose of at least 150 mg BID)
~Mirtazapine
~Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl)
~Lithium augmentation
~MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)"
11997300|NCT00612794|Drug|exenatide once weekly|subcutaneous injection, once weekly
11997301|NCT00612794|Drug|placebo|subcutaneous injection, once weekly
11997302|NCT00612781|Procedure|cataract surgery (Hoya AF-1 [UY] YA-60BB)|implantation of a yellow Hoya AF-1 (UY) YA-60BB intraocular lens
11997303|NCT00612781|Procedure|cataract surgery (Hoya AF-1 [UV] VA-60BB lens)|implantation of an uncoloured Hoya AF-1 (UV) VA-60BB
11997304|NCT00612768|Biological|TRUE Test allergens Fragrance Mix and Thimerosol|"Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose
~Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone
~Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin
~Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin
~Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours."
11997305|NCT00612755|Drug|Peginterferon alfa-2a + ribavirin|Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
11997306|NCT00612742|Drug|testosterone gel|once daily transdermal testosterone gel, 300 mcg
11997307|NCT00612742|Drug|placebo gel|once daily transdermal placebo gel
11997308|NCT00612729|Procedure|Polylens Y30 intraocular lens|cataract surgery
11997309|NCT00612729|Procedure|Orange Series Model PC 440 Y intraocular lens|cataract surgery
11997315|NCT00612690|Behavioral|Community mental health consultation model program|The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning.
11997316|NCT00612690|Behavioral|Treatment as usual (TAU)|TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems.
11997317|NCT00612677|Drug|Oxaliplatin|Dose Regimen: 120 mg/m^2 on Days 1 every 21 days
11997318|NCT00612677|Drug|Pemetrexed|Dose Regimen: 500 mg/m^2 on Days 1 every 21 days
11997319|NCT00612664|Drug|Anti-CD137 (4-1BB) (BMS-663513)|IV solution, IV, until PD or toxicity
11997320|NCT00612651|Drug|Temodar and SCH 66336|2 separate strata accrued independently: Stratum 1-pts receiving CYP3A4-inducing anticonvulsants. Stratum 2-pts on non CYP3A4-inducing anticonvulsants or pts not on any anti-convulsants. Each strata treated & escalated independent of each other. Temozolomide administered orally at dose of 150 mg/m2 daily for 5 days, at bedtime, for 1st cycle & escalated to 200 mg/m2 daily for 5 days, at bedtime during subsequent cycles if tolerated. Treatment cycles repeated every 4wks following doses of Temozolomide from previous cycle. SCH 66336 administered orally twice daily, approximately every 12hrs. Except as specifically noted, pts advised to take capsules wh morning & evening meals, with approximately 240ml of non-carbonated water. Initial doses will be 125mg BID for stratum 1 & 75mg BID for stratum2. Treatment cycles repeated every 4 wks following dose of Temozolomide from previous cycle.
11997321|NCT00612638|Drug|Temodar, O6-BG, and Irinotecan|2 separate strata accrued independently: Stratum 1-pts receiving Dilantin, Tegretol or phenobarbital. Stratum 2-pts on anti-convulsants other than Dilantin, Tegretol/phenobarbital/pts not on any anti-convulsants. O6-BG administered intravenously 120mg/m2, over 1hr, prior to administration of Temozolomide on day 1 of 21day cycle. O6-BG administered intravenously 30mg/m2/day, over 48hrs, immediately after completion of CPT-11 infusion on day 1 of 21-day cycle. Temozolomide administered orally 355mg/m2 within 60 mins of end of 1hr O6-BG infusion. Treatment cycles may be repeated every 3wks following dose of Temozolomide from previous cycle. CPT-11 administered intravenously in fasting state over 90mins. CPT-11 infusion will begin 1hr after Temozolomide administration. Initial doses 60mg/m2 for stratum 1 & 40mg/m2 for stratum2. Treatment cycles repeated every 3 wks following dose of CPT-11 from previous cycle.
11997322|NCT00612625|Drug|glucagon-like peptide-1|continuous infusion of GLP-1 (1½ pmol/kg/min)
11997323|NCT00612625|Drug|Saline|continuous infusion of saline
11997324|NCT00612612|Drug|obatoclax mesylate|Given IV
11997325|NCT00612612|Drug|fludarabine phosphate|Given IV
11997326|NCT00612612|Biological|rituximab|Given IV
11997327|NCT00612612|Other|laboratory biomarker analysis|Correlative study
11997328|NCT00612599|Drug|biphasic insulin aspart|
11997329|NCT00612586|Drug|Enzastaurin|1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease
11997330|NCT00612586|Drug|Placebo|oral, daily (up to 1 yr or until progressive disease)
11997331|NCT00612586|Drug|Leucovorin (LV)|400 milligram per meter squared (mg/m^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
11997332|NCT00612586|Drug|5-fluorouracil (5-FU)|400 mg/m^2 bolus then 2400 mg/m^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
11997333|NCT00612586|Drug|Bevacizumab (Bev)|5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
11997334|NCT00612573|Drug|Doxycycline 0.6 mg/kg/day|doxycycline 40 mg/day, oral, 12 weeks
11997335|NCT00612573|Drug|Doxycycline 1.2 mg/kg/day|doxycycline 80 mg/day, 12 weeks
11997336|NCT00612573|Drug|Doxycycline 2.4 mg/kg/day|doxycycline 160 mg/day, 12 weeks
11997337|NCT00612573|Drug|Placebo|Placebo, 12 weeks
11997338|NCT00612560|Drug|Anastrozole|1 mg per day
11997339|NCT00612560|Dietary Supplement|flaxseed|25 g per day ground
11997340|NCT00612560|Drug|Placebo|Placebo pill 1 per day
11997341|NCT00612547|Drug|Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)|"Tablet:
~Children aged between 2 and 11 months: Artesunate 25 mg + Amodiaquine 67.5 mg et Children aged between 12 and 59 months: Artesunate 50 mg + Amodiaquine 135 mg Per os one intake per day/3 day"
11997342|NCT00612534|Drug|Sufentanil NanoTab|5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
11997343|NCT00612534|Drug|Placebo NanoTab|Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
11997344|NCT00612534|Drug|Sufentanil NanoTab|10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
11997345|NCT00612534|Drug|Sufentanil NanoTab|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
11997346|NCT00612521|Drug|Adenosine|For lesions in the left coronary system the patient will receive either 120 micrograms of adenosine in 20 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis. For lesions in the right coronary system the patient will receive either 60 micrograms of adenosine in 10 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis.
11997347|NCT00612508|Drug|Desogen (ethinyl estradiol and desogestrel)|1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
11997348|NCT00612508|Drug|NuvaRing (ethinyl estradiol and etonogestrel)|Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
11997349|NCT00612495|Drug|oxaliplatin, 5 FU|"Oxaliplatin:130 mg/m² as a 2-hour intravenous (IV) infusion in 500 mL of 5% glucose solution on Day 1 and repeated every 3 weeks.
~5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 to Day 4, repeated every 3 weeks."
11997350|NCT00612482|Other|drug prevention curriculum|"Participants in the experimental arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes."
11997351|NCT00612469|Drug|Sodium Fluoride|Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
11997352|NCT00612469|Drug|vancomycin hydrochloride|Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days
11997353|NCT00612469|Drug|vancomycin hydrochloride|Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days
11997354|NCT00612469|Drug|chlorhexidine digluconate|Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days
11997355|NCT00612456|Drug|Pazopanib|Pazopanib eye drops formulation
11997356|NCT00612443|Behavioral|Sham treatment|The sham/placebo treatment will consist of the RN graduate assistant standing near the table, slowly walking around from each side and to the foot of the table stopping periodically. The RN graduate assistant will be instructed to not focus on the patient in thought. While providing the placebo treatment the RN graduate assistant will mentally do multiplication equations. This serves as a distracter to keep the RN graduate assistant from setting intention or thoughts on the participant. At no time will the RN performing the placebo treatment move hands or arms over or around the participant or come in physical contact with the participant. The placebo treatment will be a minimum of 20 minutes but no greater than 30 minutes in length. A timer will be set in the treatment room to notify the practitioner of the time limit.
11997357|NCT00612443|Behavioral|Healing Touch|Behavioral: Healing Touch The Healing Touch intervention will consist of a brief meditative state in which the practitioners sets the intention of healing for the session. A hand scan to assess the biofield; consists of a technique of where the practitioner slowly moves her hands three to six inches above the body going from head to toe, to assess for any disturbances in the biofield; a non-contact Healing Touch treatment which will follow, to include a connection of the chakras. The chakras are connected by placing the hands above the body over each chakra, starting at the feet and progressing to the head. This will be followed by smoothing the biofield, achieved by the Practitioner slowly moving her hands above the body from the head and moving towards the feet (Hover-Kramer et al., 1996). At no time will the Practitioner make physical contact with the participant during the treatment. The treatment will be 20 minutes to 30 minutes in length.
11997358|NCT00612430|Drug|Bevacizumab and Etoposide|32 pts w recurrent WHO grade III MG & 27 pts w recurrent WHO grade IV MG will be enrolled in this study. Estimated rate of accrual is 10 pts per month. The estimated date of study completion is 6-9 months from study initiation. Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If pt tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day. The Duke investigators will review all la data & order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent.
11997359|NCT00612417|Drug|Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402|Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
11997360|NCT00612391|Procedure|Lateral minimally invasive approach (plate fixation)|A longitudinally oriented, 4-cm incision will be made laterally starting at the acromion. The deltoid will be split proximally at the most strategic location (vis-à-vis the fracture), and after the deltoid is bluntly elevated from the humerus more distally the axillary nerve will be identified by digital palpation. The nerve is easily identified posteriorly as it emerges from the quadrilateral space. With a finger maintained on the nerve for protection, the plate will be inserted onto the lateral side of the proximal humerus and fixed according to the described technique. A second, 2-cm longitudinal incision will then be made further distally for diaphyseal screw placement. This incision is well distal to the course of the axillary nerve.
11997361|NCT00612391|Procedure|Deltopectoral approach (plate fixation)|Anterior, Delto-Pectoral Approach - A 10-cm incision will be made over the deltopectoral groove, starting at the coracoid process proximally. As the clavipectoral fascia is incised, the cephalic vein will be identified and retracted laterally with the deltoid muscle. The pectoralis major as well as the conjoint tendon will be retracted medially, and the long head of the biceps tendon will be identified and used as a guide for achieving an anatomic reduction of the different fracture parts. Next, internally rotating the humerus will allow access to the lateral side of the proximal humerus, on which the plate will then be fixed according to the described technique.
11997362|NCT00612378|Device|GFX System|The GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.
11997363|NCT00612352|Drug|Ethanol High Dose, Ethanol Low Dose, and Placebo|Three test days will involve administration of placebo, ethanol high dose (BrAc=100mg%) or ethanol low dose (BrAc=40mg%)intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.
11997364|NCT00612339|Drug|Avastin and Temozolomide|This is Phase II study with the combination of Avastin & Temozolomide for unresectable or multifocal WHO grade IV malignant glioma patients. Patients will receive up to 4 cycles of Avastin & Temozolomide . Avastin administered at 10 mg/kg every 14 days beginning minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide will be dosed at 200 mg/m2 daily x 5 days in 28-day cycle. Patients will have baseline MRI & repeat MRI every 4 weeks. If there is no evidence of disease progression after each cycle, or unacceptable toxicity, or as determined by investigators, patient non-compliance or patient withdraws consent to continue therapy & requests discontinuation, patients will receive up to 4 cycles of Avastin & Temozolomide, then proceed with standard XRT therapy, & future therapy after 4 cycles will be at discretion of patient & treating physicians.
11997365|NCT00612326|Procedure|MRI and PET scanning procedures|a CT scan, MRI, and C-11 Acetate PET scan. All these scans will be done as an outpatient. After you finish these scans, your doctor will schedule you for surgery to remove your bladder and lymph nodes.
11997366|NCT00612313|Drug|Fluoxetine|Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
11997367|NCT00612313|Behavioral|Relapse prevention cognitive behavioral therapy (CBT)|After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms.
11997368|NCT00612300|Behavioral|Lokomat - Physical therapy|A: Lokomat training, 30 minutes per day for 3 weeks, 5 days per week. B: Categorized gait training by physical therapist, 30 minutes per day for 3 weeks, 5 days per week
11997402|NCT00612092|Radiation|Spiral image acquisition|standard spiral scan protocol
11997403|NCT00612092|Radiation|sequential image acquisition|sequential CT scan protocol
11997369|NCT00612300|Behavioral|Physical therapy - Lokomat|"B: Daily 30 minutes of gait training with a physical therapist, 5 days per week for 3 weeks.
~A: Daily 30 minutes of Lokomat training, 5 days per week for 3 weeks."
11997370|NCT00612287|Drug|buprenorphine|Sublingual buprenorphine; product name Suboxone® (buprenorphine/naloxone). Dosing is informed by a clinical guideline which permits flexibility dependent up physician's clinical judgment. During the induction period (Day 1, at the physician's office) the first dose is 2 mg and can be brought up to 20 mg depending on patient's response. On Day 2 going forward dose can range from 2 mg q8h to 12 mg q8h. Rescue doses with buprenorphine are also permitted.
11997371|NCT00612274|Drug|tacrolimus|Tacrolimus will be administered at a dose of .02mg/kg/d IVCI beginning day -3 until able to take oral medicines reliably. Blood levels will be maintained at 5-10 ng/ml. The oral dose will be 4 times the IV dose. Tacrolimus will be converted to oral dosing prior to hospital discharge. Tacrolimus will be continued until 4 months post transplant (day +120) unless toxicity, refractory GVHD or the development of disease recurrence mandate discontinuation of the drug.
11997372|NCT00612274|Drug|Sirolimus|Sirolimus will be administered as a 12 mg oral loading dose on day -3 followed by 4mg daily. Sirolimus levels will be obtained on day +0 and then at least twice weekly to maintain a trough serum level of 3-12 ng/ml. Sirolimus will be continued until 5 months post transplant (day +150) unless toxicity, refractory GVHD or the development of disease recurrence mandate discontinuation of the drug.
11997373|NCT00612274|Drug|Methotrexate|Methotrexate, dose #1 will be administered on day +1 post transplantation, as an IV bolus, provided at least 24 hours have elapsed following infusion of donor stem cells at a dose of 10mg/m2. Dose #2 of Methotrexate will be administered 48 hours later, as IV bolus on day +3 at a dose of 5mg/m2.
11997374|NCT00612261|Procedure|Arteriovenous Crossing Sheathotomy|In each sheathotomy patient, a standard pars plana vitrectomy is performed, followed by surgical separation of the posterior cortical vitreous from the optic nerve and posterior retina. After the relevant arteriovenous crossing site is identified based on preoperative FA, a bent microvitreoretinal blade is used to open the internal limiting membrane and the nerve fiber layer over the artery, with the incision commencing 100-200 micrometer proximal to the AV crossing. The incision is continued parallel to and under the retinal arteriole, with a gentle lifting motion, until the common AV crossing sheath is encountered and incised in a side-to-side manner. The completion of AV dissection is confirmed by an elevation of the overlying artery.
11997375|NCT00612261|Procedure|Intravitreal Triamcinolone Acetonide Injection|The IVTA group receive intravitreal injection of 4 mg/0.1 mL triamcinolone acetonide (40 mg/mL; Tamceton®; Hanall Pharmaceutical, Seoul, Korea). The injections are performed using 0.5% proparacaine drops (Alcaine®; Alcon Laboratories, Fort Worth, TX) for topical anesthesia under sterile conditions. The drug is injected through the inferotemporal pars plana using a 30-gauge needle. The correct intravitreal localization of the suspension, and perfusion of the optic nerve head, are then confirmed by indirect ophthalmoscopy.
11997376|NCT00612248|Other|Splint|Patients in the study group received the splint on the day of the first evaluation and took it with them for use during activities of daily living and patients in the control group only used the splint during the evaluations
11997377|NCT00612235|Drug|Lamotrigine|Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.
11997378|NCT00612235|Drug|Levetiracetam|Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.
11997379|NCT00612235|Drug|Carbamazepine|Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.
11997380|NCT00612235|Other|No Intervention|No intervention was given
11997381|NCT00612222|Biological|autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes|ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
11997382|NCT00612222|Biological|ALVAC MART-1 Vaccine|ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
11997383|NCT00612222|Biological|aldesleukin|Aldesleukin - 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)
11997384|NCT00612222|Drug|cyclophosphamide|60 mg/kg day x 2 days intravenous in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg day x 2 days over 1 hour
11997385|NCT00612222|Drug|fludarabine phosphate|25 mg/m^2 day intravenous piggy back over 30 minutes for 5 days
11997386|NCT00612209|Drug|ARQ 197|Treatment with ARQ 197
11997387|NCT00612196|Drug|TB-402|Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
11997388|NCT00612196|Drug|Placebo|
11997389|NCT00612183|Drug|bendamustine hydrochloride|bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course.
11997390|NCT00612170|Drug|[S,S]-Reboxetine|10 mg oral tablet once a day dosing
11997391|NCT00612170|Drug|Placebo|0 mg oral tablet once a day dosing
11997392|NCT00612170|Drug|[S,S]-Reboxetine|4 mg oral tablet once a day dosing
11997393|NCT00612170|Drug|[S,S]-Reboxetine|8 mg oral tablet once a day dosing
11997394|NCT00612157|Drug|Eszopiclone|Eszopiclone 3mg orally at bedtime for 14 nights
11997395|NCT00612157|Drug|Placebo control|Matching placebo
11997396|NCT00612144|Drug|Glimepiride/metformin fixed combination|"Amaryl M 1/250mg~4/1000mg bid for 12~26 weeks
~Maintenance dose for 10 weeks after 2~14 weeks of dose titration
~Dose titration according to titration algorithm based on daily mean SMBG"
11997397|NCT00612144|Drug|Metformin HCl|"Metformin HCl 500mg~1250mg bid for 12~26 weeks
~Maintenance dose for 10 weeks after 2~14 weeks of dose titration
~Dose titration according to titration algorithm based on daily mean SMBG"
11997398|NCT00612118|Drug|GSK256066|200mcg bd
11997399|NCT00612118|Drug|azelastine hydrochloride|140mcg
11997400|NCT00612105|Drug|Retigabine|150mg/day up to 900mg/day
11997401|NCT00612105|Drug|Placebo|daily
11997405|NCT00612079|Drug|Placebo|3 x 4mg Placebo
11997406|NCT00612066|Drug|rosiglitazone maleate|
11997407|NCT00612040|Drug|insulin degludec|Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
11997408|NCT00612040|Drug|insulin degludec|Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
11997409|NCT00612040|Drug|insulin glargine|Treat-to-target dose titration scheme, injection s.c., once daily
11997410|NCT00612040|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
11997411|NCT00612014|Drug|5% dextrose in water|60 ml IV infusion over 30 minutes
11997412|NCT00612014|Drug|TZP-101|"40 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
11997413|NCT00612014|Drug|TZP-101|"80 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
11997414|NCT00612014|Drug|TZP-101|"160 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
11997415|NCT00612014|Drug|TZP-101|"320 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
11997416|NCT00612014|Drug|TZP-101|"600 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
11997417|NCT00612001|Biological|glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine|
11997418|NCT00611988|Behavioral|Self-managed walking|The intervention includes individual therapy, group reinforcement, and follow-up phone contact
11997419|NCT00611988|Other|Control group|Attention control group will receive routine follow-up phone calls
11997420|NCT00611975|Drug|Fluoxetine|Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.
11997421|NCT00611975|Drug|Bupropion|Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.
11997422|NCT00611962|Drug|Oxaliplatin, Paclitaxel|"Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient
~Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL."
11997423|NCT00611949|Other|Geranium oil|2 applications of topical oil per week for 2 weeks
11997424|NCT00611936|Drug|Placebo|Placebo
11997425|NCT00611936|Drug|Atomoxetine|20mg maximum of d-amphetamine
11997426|NCT00611923|Drug|Flutamide|Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
11997427|NCT00611923|Drug|Placebo|Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
11997428|NCT00611910|Device|sirolimus-eluting stent|due to randomization Cypher stent will be implanted
11997429|NCT00611910|Device|paclitaxel-eluting stent|due to randomization Taxus stent will be implanted
11997430|NCT00611910|Device|biodegradable-polymer-based sirolimus-eluting stent|due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
11997431|NCT00611910|Device|bare metal stents|Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist
11997432|NCT00611897|Drug|N-acetylcysteine and ketamine|Active drug (N-acetylcysteine)
11997433|NCT00611897|Drug|placebo and ketamine|placebo N-acetylcysteine
11997434|NCT00611884|Drug|insulin glargine|Treat-to-target dose titration scheme, s.c. injection.
11997435|NCT00611884|Drug|insulin degludec|Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
11997436|NCT00611884|Drug|insulin degludec|Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
11997437|NCT00611884|Drug|insulin degludec|Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
11997438|NCT00611884|Drug|metformin|Tablets, 1500-2000 mg/day
11997439|NCT00611871|Drug|Propranolol|40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
11997440|NCT00611871|Drug|Placebo|40mg placebo, followed 2 hrs after with 60mg placebo
11997441|NCT00611858|Drug|Cetuximab|
11997442|NCT00611858|Drug|5-Fluorouracil|
11997443|NCT00611858|Radiation|Radiation|
11997444|NCT00611845|Drug|Aprotinin (Trasylol, BAYA0128)|Trasylol at either 1,000,000 KIU or 2,000,000 KIU
11997445|NCT00611832|Behavioral|"Triple P Media Series -- Standard Information-Only version"|10 episodes, 12 minutes per episode, 2 episodes viewed per week for a total of 5 weeks. Demonstrates parenting practices for effectively handling a range of difficult child behaviors.
11997446|NCT00611832|Behavioral|"Triple P Media Series -- Enhanced Behavior Activation version"|10 episodes, 12 minutes per episode, 2 episodes viewed per week for a total of 5 weeks. Demonstrates parenting practices for effectively handling a range of difficult child behaviors; includes specific content elements designed to promote parents' adoption of the targeted parenting skills
11997447|NCT00611819|Drug|Peg interferon + Ribavirin|Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
11997448|NCT00611819|Drug|Peg interferon + Ribavirin|Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
11997449|NCT00611806|Dietary Supplement|Folic Acid|Folic acid 2mg po daily
11997450|NCT00611806|Dietary Supplement|B12|B12 400 micrograms po daily
11997451|NCT00611806|Other|Placebo|1 capsule po daily
11997485|NCT00611533|Drug|atomoxetine|Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
11997452|NCT00611793|Drug|PTK787/ZK222584 and Bevacizumab|PTK787/ZK222584 will be administered as a single agent orally on days 1-14 of cycle 1. The day 14 dose of PTK787/ZK222584 will be administered in the outpatient clinic and PK samples will be obtained. On Day 15 the patient will receive the initial dose of IV bevacizumab and PTK787/ZK222584. Bevacizumab will be repeated at 2 week intervals in patients with stable disease or better for four cycles of treatment (16 weeks). After four treatment cycles, only patients with a PR or CR will continue treatment with PTK787/ZK222584 and bevacizumab. Patients with stable disease may continue single agent PTK787/ZK22258 from cycle 5 onward. Protocol treatment will continue until disease progression or intolerable toxicity warrants drug discontinuation.
11997453|NCT00611780|Radiation|tube voltage|standard 120 kV
11997454|NCT00611780|Radiation|tube voltage|reduced voltage of 100 kV
11997455|NCT00611767|Drug|Thiopental|A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion).
11997456|NCT00611767|Drug|Placebo|A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion).
11997457|NCT00611754|Drug|Oxaliplatin, 5-FU|Oxaliplatin: 130 mg/m² in 500 mL of 5% glucose solution as a 2-hour intravenous (IV) infusion on Day 1 and repeated every 3 weeks; 5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 toDay 4, every 3 weeks.Dose adjustments were made if the patient experienced AEs.
11997458|NCT00611741|Drug|furosemide, Na supplements|furosemide 20 mg, Na supplements 8g in divided doses/day for 5 days
11997459|NCT00611728|Drug|SU011248 & Irinotecan|"Sutent given in daily oral manner for 1st 4 wks of each 6wk cycle. You will not take any Sutent during last 14 days of each 6 wk cycle. CPT-11 will be given intravenously over 1 & 1/2 hrs on 1st day of each cycle & then again on days 14 & 28.
~Sutent is approved for adult subjects w some forms of kidney cancer. It is considered investigational for brain tumors. Dosing will begin on day 1 of cycle 1 & continue daily for 4 wks by mouth.
~Irinotecan is approved for adult subjects with some forms of colorectal cancer. It is also considered investigational for brain tumors. Irinotecan dose will depend on your height & weight. Irinotecan will be given intravenously over 90 min on days 1, 14 & 28 of 6wk cycle.
~You will be seen in clinic approximately every 42 days for 1st 3 cycles of study drug, & then every other cycle thereafter. Your brain MRI examination will be done within 1 wk prior to completion of cycles 1-3, & then within 1 week prior to completion of every other cycle."
11997460|NCT00611715|Drug|erlotinib hydrochloride|OSI-774 150 mg/day
11997461|NCT00611715|Drug|letrozole|Letrozole 2.5 mg/day
11997462|NCT00611715|Genetic|fluorescence in situ hybridization|To determine HER2 gene amplification or excess copies of the HER2 gene
11997463|NCT00611715|Other|immunohistochemistry staining method|to measure the epidermal growth factor receptors (EGFR)
11997464|NCT00611715|Other|laboratory biomarker analysis|To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
11997465|NCT00611702|Procedure|Kidney biopsy|Kidney biopsy (recipients only) will be obtained for RT-PCR, microarray analyses and histology.
11997466|NCT00611689|Drug|Imatinib and PTK/ZK222584|Imatinib and PTK/ZK will each be administered orally daily. Two dose levels of imatinib (400 mg and 600 mg) will be tested with 4 dose levels of PTK/ZK (250 mg, 500 mg, 750 mg, and 1000 mg). 3 patients will be accrued at each individual dose level. If dose-limiting toxicities are reported in ≤ 1/3 patients, the dose level will be expanded to 6 patients. If dose-limiting toxicities are reported in < 2/6 patients, then dose escalation will continue. If ≥ 2/6 patients experience dose-limiting toxicity, the next lower dose will be considered the maximum tolerated dose and will be expanded to a total of 12 patients. There will be no intrapatient dose escalations. Patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered.
11997467|NCT00611676|Drug|Venlafaxine|Weeks 0-2: placebo. Weeks 2-3: 75 mg Venlafaxine. Weeks 3-4: 150 mg Venlafaxine. Weeks 4-12: 150-225 mg Venlafaxine.
11997468|NCT00611663|Biological|Prevenar® and Pneumo23®|Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE)at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2)
11997469|NCT00611663|Biological|Placebo, Pneumo23®|Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24
11997470|NCT00611650|Drug|defined green tea catechin extract|Given orally
11997471|NCT00611650|Other|placebo|Given orally
11997472|NCT00611637|Biological|CMV pp65 Specific T Cells|Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.
11997473|NCT00611624|Radiation|Mammosite brachytherapy radiation|Treatment using MammoSite will begin within five days of placement of the catheter. Only high dose rate (HDR) with Ir-192 treatment is allowed. The balloon will remain inflated throughout the treatment course. A total of 34 Gy will be prescribed to an approximate 1 cm radial distance from the balloon surface. Two fractions per day, each of 3.4 Gy, separated by at least 6 hours, given on 5 treatment days (over a period of 5 to 10 days), will sum to 10 fractions and 34 Gy.
11997474|NCT00611611|Biological|fluzone|once
11997475|NCT00611611|Biological|pneumovax|once
11997476|NCT00611598|Other|Blood draw and Questionnaires|Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
11997477|NCT00611598|Other|Blood draw and Questionnaires|Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
11997478|NCT00611585|Device|Birmingham Hip Resurfacing|Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty
11997479|NCT00611572|Drug|iomazenil|Given as IV infusion
11997480|NCT00611572|Drug|iomazenil|saline IV infusion
11997481|NCT00611559|Biological|Infanrix™ penta|Subjects received a booster dose
11997482|NCT00611559|Biological|Infanrix™ hexa|Subjects received a booster dose
11997483|NCT00611546|Other|Photo-protection|Parenteral solutions are protected from day light using aluminum covers
11997484|NCT00611546|Other|Photo-exposure|Perenteral nutrition bottles and tubings are allowed to be exposed to day light.
11997486|NCT00611533|Drug|placebo|Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
11997487|NCT00611507|Drug|Oxaliplatin, 5-Fluorouracil|5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.
11997488|NCT00611494|Drug|MMF|Gradual optimization of drug dosage, as clinically tolerated.
11997489|NCT00611494|Drug|EC-MPS|Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
11997490|NCT00611481|Behavioral|Tai Chi|a set of pre-designed Tai Chi Movements
11997491|NCT00611481|Behavioral|Strength training|Lower-extremity strength training exercises
11997492|NCT00611481|Behavioral|Low-Impact Exercise Control|a set of chair-based low-impact exercises
11997493|NCT00611468|Drug|Topotecan|All subjects receive treatment with intravenous topotecan and oral erlotinib.
11997494|NCT00611468|Drug|Erlotinib|All subjects receive treatment with intravenous topotecan and oral erlotinib.
11997495|NCT00611455|Drug|ofatumumab|1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period
11997496|NCT00611455|Drug|Placebo|1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period
11997497|NCT00611442|Drug|lubiprostone|lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
11997498|NCT00611442|Drug|placebo|placebo gelcap, taken at noon the day prior to the colonoscopy
11997499|NCT00611429|Behavioral|Counseling sessions|The individual counseling sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment.
11997500|NCT00611429|Behavioral|Group workshop|During the 3-hour group workshop, doctors, nurses, and case managers will talk to participants about HIV treatments and what it is like to undergo treatment. Participants will also hear from other people with HIV and their experiences with treatment.
11997501|NCT00611416|Dietary Supplement|green tea|different catechin combinations
11997502|NCT00611416|Dietary Supplement|Mix of catechins and caffeine|3 tablet a day
11997503|NCT00611416|Dietary Supplement|EGCG|3 tablets a day
11997504|NCT00611416|Dietary Supplement|EGC|3 tablets a day
11997505|NCT00611416|Dietary Supplement|Caffeine|3 tablets a day
11997506|NCT00611416|Dietary Supplement|Placebo|3 tablets a day
11997507|NCT00611403|Drug|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)|Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
11997508|NCT00611403|Drug|Artificial Tears REFRESH ENDURA®|REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
11997509|NCT00611390|Dietary Supplement|mixture of aromatic essential oils.|3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the larynx.
11997510|NCT00611390|Dietary Supplement|placebo|0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.
11997511|NCT00611364|Other|Physical Therapy and education meetings|Physical therapy was realized three two times per week and education meeting every fifteen days
11997512|NCT00611364|Other|education meetings|This group only participed of education meeting (every fifteen days)
11997513|NCT00611351|Biological|anti-thymocyte globulin|
11997514|NCT00611351|Drug|busulfan|
11997515|NCT00611351|Drug|cyclophosphamide|
11997516|NCT00611351|Drug|mycophenolate mofetil|
11997517|NCT00611351|Drug|tacrolimus|
11997518|NCT00611351|Genetic|polymerase chain reaction|
11997519|NCT00611351|Genetic|polymorphism analysis|
11997520|NCT00611351|Other|flow cytometry|
11997521|NCT00611351|Other|laboratory biomarker analysis|
11997522|NCT00611351|Other|pharmacogenomic studies|
11997523|NCT00611351|Other|pharmacological study|
11997524|NCT00611351|Procedure|allogeneic bone marrow transplantation|
11997525|NCT00611351|Procedure|allogeneic hematopoietic stem cell transplantation|
11997526|NCT00611351|Procedure|peripheral blood stem cell transplantation|
11997527|NCT00611338|Behavioral|HIV Skills-based Prevention|
11997528|NCT00611325|Drug|Avastin|Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.
11997529|NCT00611325|Drug|Bortezomib|Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs & 2.5 mg/m2 for patients taking EIAEDs.
11997530|NCT00611312|Behavioral|Cognitive Training|Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day
11997531|NCT00611299|Dietary Supplement|BB-12 and CRL 431|
11997532|NCT00611286|Drug|clopidogrel treatment after bare metal stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of bare metal stent
11997533|NCT00611286|Drug|clopidogrel treatment after bare metal stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 1 month after BMS implantation.
11997534|NCT00611286|Drug|clopidogrel after zotarolimus-eluting stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of zotarolimus-eluting stent coronary implantation
11997535|NCT00611286|Drug|clopidogrel after paclitaxel-eluting stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of paclitaxel-eluting stent
11997536|NCT00611286|Drug|clopidogrel after everolimus-eluting stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of Everolimus-eluting stent
11997537|NCT00611286|Drug|clopidogrel after zotarolimus-eluting stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
11997586|NCT00610948|Drug|fluorouracil|Given IV
11997587|NCT00610948|Drug|leucovorin calcium|Given IV
11997538|NCT00611286|Drug|clopidogrel after paclitaxel-eluting stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
11997539|NCT00611286|Drug|clopidogrel after everolimus-eluting stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
11997540|NCT00611273|Device|GFX|The GFX system employs minimally invasive technique utilizing Bi-polar (radio frequency) RF technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.
11997541|NCT00611260|Behavioral|Vipassana Meditation practice and instruction|2-3 instructed meditation sessions per week in addition to standard medical care.
11997542|NCT00611260|Other|Standard Medical Care|Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
11997543|NCT00611247|Drug|Temozolomide|"Priming, Group 2 only, 100 mg/m2/day temozolomide.
~Induction (both arms) 200 mg/m2/day temozolomide"
11997544|NCT00611221|Procedure|Massage|Massage therapy by an RMT during labour
11997545|NCT00611221|Procedure|Massage|Massage by anyone else, eg. husband, nurse, doula
11997546|NCT00611208|Biological|A-dmDT390-bisFv(UCHT1)|A-dmDT390-bisFv(UCHT1) will be administered as 60 μg/kg total given as 7.5 μg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes
11997547|NCT00611195|Drug|propofol, remifentanil|propofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min
11997548|NCT00611169|Drug|tirofiban|tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
11997549|NCT00611156|Dietary Supplement|ginger|added to a brunch meal
11997550|NCT00611156|Dietary Supplement|black pepper|Added to a brunch meal
11997551|NCT00611156|Dietary Supplement|horseradish|Added to a brunch meal
11997552|NCT00611156|Dietary Supplement|mustard|Added to a brunch meal
11997553|NCT00611156|Dietary Supplement|placebo|Added to a bruch meal
11997554|NCT00611143|Drug|atorvastatin|atorvastatin 20 mg/d, started 3 days before surgery
11997555|NCT00611130|Drug|vigabatrin|Tablets twice a day for 9 weeks
11997556|NCT00611130|Drug|placebo|tablets twice daily for 9 weeks
11997557|NCT00611117|Other|Physical Activity Level|High vs. low physical activity during a high fat diet consumption.
11997558|NCT00611104|Dietary Supplement|standardized freeze-dried table grape powder|
11997559|NCT00611104|Other|laboratory biomarker analysis|
11997560|NCT00611104|Other|pharmacological study|
11997561|NCT00611091|Other|Electronic delivery of enhanced discharge information to the ambulatory physician|Follow-up appointment needs/plans
11997562|NCT00611091|Other|Electronic delivery of enhanced discharge information to the ambulatory physician|Laboratory follow-up needs
11997563|NCT00611091|Other|Electronic delivery of enhanced discharge information to the ambulatory physician|New medications
11997564|NCT00611065|Device|magnetic resonance imaging|MR contrast agent (0.1 mmol/kg)
11997565|NCT00611052|Behavioral|the Adolescent Coping with Stress|A group cognitive intervention, manualized and highly structured. Includes 8 sessions (á 1.5 hours) and a booster session 6 months after termination of the actual intervention. Groups leaders are specifically trained for this course.
11997566|NCT00611052|Behavioral|Treatment as usual|The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.
11997567|NCT00611052|Other|usual health education|usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale
11997568|NCT00611039|Drug|Darunavir 900mg + ritonavir 100 mg once a day|Darunavir 900mg + ritonavir 100 mg once a day
11997569|NCT00611039|Drug|Darunavir 600mg + ritonavir 100mg twice day|Darunavir 600mg + ritonavir 100mg twice day
11997570|NCT00611026|Drug|Tolterodine ER|The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
11997571|NCT00611026|Drug|Placebo|Placebo treatment will be once daily(QD) for 12 weeks.
11997572|NCT00611026|Drug|Fesoterodine|The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
11997573|NCT00611013|Device|Magnetic Resonance Imaging|Some participants may receive MRI contrast agent, 0.1 mmol/kg
11997574|NCT00611000|Dietary Supplement|folic acid|
11997575|NCT00611000|Genetic|DNA methylation analysis|
11997576|NCT00611000|Genetic|gene expression analysis|
11997577|NCT00611000|Genetic|microarray analysis|
11997578|NCT00611000|Genetic|polymorphism analysis|
11997579|NCT00611000|Other|laboratory biomarker analysis|
11997580|NCT00610987|Drug|cefazolin|Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours.
11997581|NCT00610987|Drug|Placebo|Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo.
11997582|NCT00610974|Behavioral|Body-weight supported treadmill training|BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
11997583|NCT00610974|Behavioral|Body-weight supported treadmill training|BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
11997584|NCT00610948|Biological|panitumumab|Given IV
11997585|NCT00610948|Drug|everolimus|Given orally
11997588|NCT00610948|Drug|oxaliplatin|Given IV
11997589|NCT00610935|Drug|Peramivir|To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.
11997590|NCT00610935|Drug|Placebo|Single intramuscular injection
11997591|NCT00610922|Dietary Supplement|Docosahexaenoic acid (DHA)|DHA 20 mg per day through 12 months of life
11997592|NCT00610909|Drug|Paroxetine CR|Those in the active treatment group will receive doses of Paxil CR in increments of 12.5 mg daily for the first week and increased at 12.5 mg increments at visit weeks to a maximum of 50 mg daily, as determined by the investigator. The investigator will adjust dosage based on clinical response. Following the completion of the double-blind phase, patients on placebo and non-responders to the study drug will be tapered off the study drug back to 0 over 2 weeks, and they will be referred to their Primary Care Physician, Internist or Gastroenterologist to be prescribed treatment for Irritable Bowel Syndrome.
11997593|NCT00610909|Drug|Placebo|Placebo
11997594|NCT00610883|Drug|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU|LSA4 intervention includes three phases: induction, consolidation and maintenance
11997595|NCT00610870|Drug|atorvastatin|atorvastatin 80mg/day before primary coronary intervention
11997596|NCT00610857|Drug|Anti-CTLA4 monoclonal antibody and HDI|"One course of therapy consists of three cycles (1 cycle=28days). Anti-CTLA4 monoclonal antibody (15 mg/kg i.v.) will be given during the first cycle only. HDI will be given all three cycles - cycle 1: 20 MU/m2 i.v. on days 0, 1, 2, 3, 4 a week (MTWRF) for 4 weeks; cycle 2: 10 MU/m2 s.c. 3 days a week (MWF) for 4 weeks; and cycle 3: 10 MU/m2 s.c. 3 days a week (MWF) for 4 weeks.
~Response assessment will be carried out at day 56 and day 84. Every patient will receive 3 cycles regardless of response status after the first 2 cycles. However, a patient may be taken off therapy in the event of clinical progression at the discretion of the treating physician.
~Patients without evidence for disease progression after 3 cycles may be offered additional cycles two weeks after completion of the third cycle. Therapy will continue for a maximum of 12 months."
11997597|NCT00610844|Procedure|pulmonary radiofrequency ablation|CT-guided pulmonary radiofrequency ablation
11997598|NCT00610831|Device|DIRECTVIEW CR Mammography|4 views screening mammogram
11997599|NCT00610818|Other|Palifermin|day -14, -13, -12 before transplant and then day 0,1,2 after transplant
11997600|NCT00610805|Other|Preventive Cardiology|Patients will receive those interventions recommended by the Preventive Cardiologist. This may include: exercise, electrocardiogram, specialized blood testing, blood pressure monitoring, nutrition counseling, smoking cessation counseling, and pharmacotherapy for hypercholesterolemia, hypertension, and blood sugar abnormalities.
11997601|NCT00610805|Other|Usual Care|Participants will receive usual care per their primary care physician.
11997602|NCT00610792|Drug|bortezomib|1.3 mg/m2 on Days 1, 4, 8 & 11 every 3 weeks (1 cycle = 21 days) for up to six cycles
11997603|NCT00610792|Drug|pegylated liposomal doxorubicin|30 mg/m2 on Day 1 every 3 weeks (1 cycle = 21 days) for up to six cycles
11997604|NCT00610779|Dietary Supplement|mixture of aromatic essential oils.|1% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the nose.
11997605|NCT00610779|Dietary Supplement|placebo|0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.
11997606|NCT00610753|Behavioral|Family Behavior Therapy|This treatment is usually delivered in two phases: In the first phase there is an initial investigation of family behavior around feeding using a family meal followed by family therapy focused on enhancing feeding of the anorexic child in order to promote weight gain. In the second phase, once weight gain is well established the adolescent is given greater autonomy over feeding and in later sessions over other issues.
11997607|NCT00610753|Behavioral|Systems Family Therapy|This therapy is applied in three phases. 1. In the first 2 or 3-sessions the treatment is explained to the family and an initial examination of family issues begins. 2. In the second phase family interactions and psychological processes are explored with clarification for family members. 3. In the third phase knowledge of family patterns is refined aiming for behavior change.
11997608|NCT00610740|Drug|topical gemcitabine hydrochloride|Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
11997609|NCT00610740|Procedure|therapeutic conventional surgery|hysterectomy
11997610|NCT00610727|Drug|Prochlorperazine 0.5 mg IV over 5 sec|IV Prochlorperazine for bioavailability
11997611|NCT00610727|Drug|Inhaled prochlorperazine 0.625 mg|Inhaled Staccato Prochlorperazine 0.625 mg
11997612|NCT00610727|Drug|Inhaled prochlorperazine 1.25 mg|Inhaled Staccato Prochlorperazine 1.25 mg
11997613|NCT00610727|Drug|Inhaled prochlorperazine 2.5 mg|Inhaled Staccato Prochlorperazine 2.5 mg
11997614|NCT00610727|Drug|Inhaled prochlorperazine 5 mg|InhaledStaccato Prochlorperazine 5 mg
11997615|NCT00610727|Drug|Inhaled prochlorperazine 10 mg|InhaledStaccato Prochlorperazine 10 mg
11997616|NCT00610727|Drug|Inhaled placebo|Inhaled Staccato Placebo (0 mg)
11997617|NCT00610727|Drug|Prochlorperazine 10 mg IV over 5 sec|Prochlorperazine 10 mg IV over 5 sec for patient qualification
11997618|NCT00610714|Drug|AZD0530|oral once daily dose
11997619|NCT00610714|Drug|Carboplatin|intravenous injection
11997620|NCT00610714|Drug|Paclitaxel|intravenous infusion
11997621|NCT00610701|Device|Anterior pin placement|Anteriorly-placed (front of the leg) femoral external fixator pins
11997622|NCT00610701|Device|Lateral pin placement|Laterally-placed (side of the leg) femoral external fixator pind
11997623|NCT00610688|Drug|Prenatal Vitamin|Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
11997624|NCT00610688|Drug|Cholecalciferol (Vitamin D3)|Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
11997625|NCT00610688|Drug|Cholecalciferol (Vitamin D3)|Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
11997626|NCT00610675|Drug|Org 50081|One tablet daily
11997627|NCT00610649|Drug|MK-8777|Orally administered capsules containing either 50 mg or 100 mg MK-8777.
11997628|NCT00610649|Drug|Placebo|Orally administered matching placebo capsules.
11997629|NCT00610636|Procedure|Hepatic resection|Hepatic resection
11997630|NCT00610623|Drug|azithromycin|300 mg/day, IV from day 1 to 20
11997631|NCT00610623|Drug|placebo|once per day, IV from day 1 to 20
11997632|NCT00610610|Drug|Paroxetine CR|Those in the active treatment group will receive doses of Paxil CR in the following manner: week 1: 12.5 mg per day, week 2: 25 mg per day, week 3: 37.5 mg per day, wk 4: 50 mg per day and week 5: 62.5 mg per day.
11997633|NCT00610610|Drug|Placebo|Same shape Placebo
11997634|NCT00610584|Procedure|acupuncture|arm 1: verum acupuncture group: 12 interventions (semi-standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
11997635|NCT00610584|Procedure|minimal (sham)acupuncture|arm 2: minimal (sham) acupuncture group: 12 interventions (standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
11997636|NCT00610584|Drug|cetirizine dihydrochloride (rescue medication)|arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone
11997637|NCT00610571|Drug|Oral Topotecan and Temodar|"Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day.
~Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose."
11997638|NCT00610558|Device|Arm 1: Juvenile Myoclonic Epilepsy|Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
11997639|NCT00610558|Device|Arm 2: Frontal Lobe Epilepsy|Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
11997640|NCT00610558|Device|Arm 3: Normal Controls|Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
11997641|NCT00610545|Drug|Atorvastatin|Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
11997642|NCT00610545|Drug|Atorvastatin|Atorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
11997643|NCT00610532|Drug|phenytoin|intravenous phenytoin (15 mg/kg) single dose
11997644|NCT00610532|Drug|phenytoin and probenecid|intravenous phenytoin (15 mg/kg) single dose and oral probenecid 2000 mg single dose
11997645|NCT00610519|Dietary Supplement|mixture of aromatic essential oils.|3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the throat.
11997646|NCT00610519|Dietary Supplement|placebo|0:1% of Lemon VIP (Florasynth,Israel), spraying to the throat.
11997647|NCT00610506|Drug|Escitalopram|Escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability.
11997648|NCT00610493|Drug|Bevacizumab|5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle
11997649|NCT00610493|Drug|Temsirolimus|5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle
11997650|NCT00610493|Procedure|Additional Blood Drawn|2 teaspoons each time: 4xDay Cycle 1 after start of first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at end of Cycle 1.
11997651|NCT00610493|Procedure|Biopsy|First tumor biopsy during screening visit and Second at the end of Cycle 1
11997652|NCT00610493|Procedure|DCE-MRI Scan|DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1
11997653|NCT00610480|Drug|1st visit Optive, then 2nd visit Systane|"First visit: Instillation of Optive followed by evaporometry assessment after 30 minutes.
~Second visit: Instillation of Systane followed by evaporometry assessment after 30 minutes."
11997654|NCT00610480|Drug|1st visit Systane, then 2nd visit Optive|"First visit: Instillation of Systane followed by evaporometry assessment after 30 minutes.
~Second visit: Instillation of Optive followed by evaporometry assessment after 30 minutes."
11997655|NCT00610467|Device|Disease Group|Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
11997656|NCT00610467|Device|Control Group|Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
11997657|NCT00610454|Drug|Levetiracetam|
11997658|NCT00610441|Drug|MK-8777|
11997659|NCT00610441|Drug|Placebo|
11997660|NCT00610428|Drug|Staccato Placebo|Inhaled Staccato Placebo
11997661|NCT00610428|Drug|Staccato Prochlorperazine 5 mg|Inhaled Prochlorperazine 5 mg
11997662|NCT00610428|Drug|Staccato Prochlorperazine 10 mg|Inhaled Prochlorperazine10 mg
11997663|NCT00610415|Procedure|tumor biopsy|
11997664|NCT00610402|Other|blood sample tear drop sample|blood sample tear drop sample
11997665|NCT00610389|Biological|immunotherapy with dendritic cells|We will administer four daily doses (repeated every 24 hours)o dendritic cells in two cycles one month apart. We will administer systemic treatment with PEG-IFN alfa and GM-CSF to potentiate activity.
11997666|NCT00610376|Behavioral|Preschool handwashing intervention program|This preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment.
11997667|NCT00610376|Behavioral|Home component intervention|The home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card.
11997668|NCT00610363|Biological|Rilonacept|Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
11997669|NCT00610363|Other|Placebo (for Rilonacept)|Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
11997670|NCT00610350|Drug|levosimendan|24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
11997671|NCT00610350|Drug|Placebo|an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
11997672|NCT00610337|Drug|Cethrin® (BA-210)|Intraoperative epidural administration during spinal decompression surgery
11997673|NCT00610337|Procedure|placebo|Spinal decompression surgery without administration of Cethrin® BA-210
11997674|NCT00610324|Drug|Chlorhexidine gluconate|Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
11997675|NCT00610324|Drug|Potassium permanganate|Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
11997676|NCT00610311|Drug|cyclophosphamide|60 mg/kg day x 2 days intravenous in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg day x 2 days over 1 hour
11997677|NCT00610311|Drug|fludarabine phosphate|25 mg/m^2 day intravenous piggy back over 30 minutes for 5 days
11997678|NCT00610311|Biological|Aldesleukin|720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
11997679|NCT00610311|Biological|ALVAC gp100 Vaccine|0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL)
11997680|NCT00610311|Biological|anti-gp100:154-162 Tcell receptor (TCR) peripheral blood lymphocyte (PBL)|3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
11997681|NCT00610298|Device|whole body vibration using a Galileo vibrating platform|whole body vibration at 20 hertz for 3 minutes 3 to 5 days per week for up to 12 weeks
11997682|NCT00610285|Other|Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)|Each patient in the protocol will receive their regularly scheduled SRS treatment plus an additional mock treatment using the non-invasive immobilization system.
11997683|NCT00610272|Radiation|Radiotherapy|4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
11997684|NCT00610272|Radiation|Radiotherapy|8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
11997685|NCT00610272|Radiation|Radiotherapy|8 Gy in a single fraction; retreatments > 4 weeks, using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy) ; second reirradiation with 8 Gy using local RT fields optional (at discretion of PI);
11997686|NCT00610272|Radiation|Radiotherapy|12 Gy in 4 fractions of 3 Gy in 2 consecutive days interfraction interval of a minimum of 6 hrs; retreatments > 4 weeks using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy); second reirradiation with 8 Gy using local RT fields optional (at discretion of PI) ;
11997687|NCT00610259|Behavioral|brief behavioral therapy for insomnia (bBT-I)|4 50-minute individual sessions every week for 4 weeks
11997688|NCT00610259|Other|Treatment as usual (TAU)|The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.
11997689|NCT00610246|Drug|Sorafenib|Sorafenib orally for one week prior to radiation, then concomitantly for two weeks with radiation and then for one week following completion of radiation. Each anatomic cohort will dose escalate independently. Dose level 1 is 200mg of sorafenib. If full oral dose (400mg orally, twice a day) is reached in a given cohort then an additional dose level will open where sorafenib treatment is extended following radiation for a total of eight weeks.
11997690|NCT00610233|Procedure|deep brain stimulation ON|deep brain stimulation in the ON state
11997691|NCT00610233|Procedure|Deep brain stimulation OFF|Urodynamic investigation with deep brain stimulation in the OFF state
11997692|NCT00610220|Device|Fiberglass short arm cast|Cast will be applied for a 4-week period
11997693|NCT00610220|Device|Prefabricated wrist splint|Splint will be applied for a 4-week period
11997694|NCT00610207|Device|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)|Surgical placement of the Surgisis AFP is performed under general anesthesia
11997695|NCT00610194|Drug|RDEA119|In the dose escalation phase, subjects will receive a single oral dose of RDEA119 on Day 1, wait 1 week, then begin a 28-day course of daily continuous dosing of RDEA119. In the expanded MTD phase, subjects will receive RDEA119 once or twice a day beginning on Day 1, and begin a 28-day course of continuous dosing at that time.
11997696|NCT00610181|Procedure|MRI|MRI of both breasts, results used for surgery, then MRI repeated in 1 year as part of routine follow-up after surgery.
11997697|NCT00610168|Biological|Boostrix TM|Single booster dose of vaccine
11997698|NCT00610155|Drug|Placebo|BID
11997699|NCT00610155|Drug|Pregabalin|Dose 75 mg titrated to 150 mg, bid
11997700|NCT00610155|Drug|Tramadol SR|Dose 50mg titrated to 200 mg, bid
11997701|NCT00610142|Drug|pimecrolimus 1% cream|twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
11997702|NCT00610142|Drug|hydrocortison 1% cream|twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
11997703|NCT00610129|Drug|MK-0646|MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes.
11997704|NCT00610116|Device|Electronic Repositioning|Change of pacing vectors for CRT pacing
11997705|NCT00610103|Drug|apomorphine hydrochloride|Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.
11997706|NCT00610090|Device|UniFit AAA Stent Graft|Endovascular repair of Abdominal Aortic Aneurysms
11997707|NCT00610077|Drug|Letrozole|Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
11997708|NCT00610077|Drug|Clomiphene citrate|Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
11997709|NCT00610064|Radiation|Baseline neuroimaging|Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
11997710|NCT00610064|Radiation|Neuroimaging during sacral neuromodulation|Neuroimaging during sacral neuromodulation using PET
11997711|NCT00610051|Drug|Alprostadil|central venous access continuous delivery with 2.5ng/kg/min
11997712|NCT00610038|Drug|glibenclamide|Switching the patients from subcutaneous insulin to oral glibenclamide therapy
11997713|NCT00610025|Procedure|Transgastric access to the abdomen|Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
11997714|NCT00609999|Drug|Erlotinib and Dasatinib|You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected & will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 & at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib & Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib & Erlotinib given daily for 28 days for purpose of scheduling evaluations.
11997715|NCT00609986|Drug|insulin|"The intravenous regular insulin infusion will be delivered continuously during the transplant surgery and after surgery for a total of three days. While receiving the insulin infusion, the dose will be calculated to keep the blood sugar levels between 70-110 mg/dL.
~After the regular insulin infusion is discontinued, the blood sugar levels will be measured by a finger stick blood glucose up to 5-6 times per day and the blood sugar levels will be corrected by a subcutaneous basal-bolus insulin injection for a blood sugar goal 70-110 mg/dL.
~Upon discharge from the hospital, the patient will be placed on a basal-bolus regimen consisting of 3-4 insulin injections to maintain a blood sugar between 70-140."
11997716|NCT00609986|Drug|NPH Insulin or glargine insulin and aspartame insulin|"The NPH or glargine and aspartame insulin will be given subcutaneously using a small-short needle to administer the insulin.
~The blood sugar level will be checked every 1 hour while in the operating room and treated with rapid-acting insulin as needed to keep the blood sugar levels 70-180 mg/dL. The blood sugar level will be checked every 4 hours when in the recovery room and on the 6 East transplant unit. Once the patient is able to eat, the blood sugar will be checked five times a day (before meals, at bedtime, and at 3:00 am). Long-acting and rapid-acting insulin will be used to maintain the target blood sugar level.
~Upon discharge from the hospital, the patient will be placed on a minimum of one to two insulin injections to maintain a blood sugar between 90-180 mg/dL"
11997717|NCT00609973|Drug|Ciprofloxacin|Ciprofloxacin 500 mg oral bid for 6 months
11997718|NCT00609973|Drug|Placebo|Placebo bid for 6 months
11997719|NCT00609960|Behavioral|clowns present|clowns present during the proccess of induction of anesthesia
11997720|NCT00609960|Drug|midazolam|midazolam
11997721|NCT00609947|Device|Endeavor Zotarolimus-Eluting Coronary Stent|
11997722|NCT00609934|Drug|Sorafenib|Dose level 1: sorafenib 200mg PO OD on Days 1-84 Dose level 2: sorafenib 400mg PO OD on Days 1-84
11997723|NCT00609934|Radiation|external beam radiotherapy|3000cGy in 10 fractions
11997724|NCT00609921|Drug|ARQ197|treatment
11997725|NCT00609908|Procedure|Split skin graft|After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)
11997726|NCT00609908|Procedure|skin stretching device|after woundbed preparation the wound is primarily closed by aid of the skin stretching device
11997727|NCT00609908|Procedure|serial excision|as much scar as possible is excised, whereafter the wound is closed
11997728|NCT00609908|Procedure|skin stretching device|after the scar is excised, the wound is primarily closed by aid of the skin stretching device
11997729|NCT00609895|Drug|INSULIN GLARGINE|
11997730|NCT00609882|Other|Nasal CPAP|"Infants randomized to the Standard nasal CPAP via bubble or ventilator support at levels of 4-8 cm H2O post extubation"
11997731|NCT00609882|Other|Humidified High Flow Nasal Cannula (HHFNC)|HHFNC
11997732|NCT00609869|Drug|Lenalidomide|Lenalidomide was administered orally with escalating doses on 28-days cycles. The first cycle was administered with a starting dose of 2.5 mg daily on days 1-7, 5mg on days 8-14 and 10 mg on days 15-21, followed by seven days off. On cycle 2 and beyond lenalidomide was administered at 20 mg daily on days 1-21.
11997733|NCT00609869|Drug|Rituximab|Rituximab was administered at 375 mg/m^2 intravenously on a weekly basis for the first cycle starting on day 15. Subsequent rituximab doses were administered on day one of cycle 2 and beyond, every 4 weeks. Doses were repeated on 28-day cycles until disease progression or unacceptable toxicity, but were planned for 12 cycles.
11997734|NCT00609856|Drug|pioglitazone|tablet, 30 mg, once daily, 26 weeks
11997735|NCT00609856|Drug|insulin glargine|subcutaneous injection, start dose 6-10 units, once daily, 26 weeks
11997736|NCT00609843|Other|Lipiodol demarcation of the bladder tumour|1-3 drops of Lipiodol Ultra Fluid (iodine 38%W/W) will be injected into the submucosa on 4 locations around the bladder tumour. The procedure is done once during a planned cystoscopy approximately a week before the planning CT.
11997737|NCT00609830|Behavioral|Tailored Materials|Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior.
11997738|NCT00609830|Behavioral|Tailored Materials Plus Physician Feedback|Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participant's stage of change with respect to each behavior. In additon, the participant's physician received information concerning the participant's status on each behavior targeted.
11997739|NCT00609830|Behavioral|Generic Materials|Participants received generic written educational materials about osteoporosis prevention.
11997740|NCT00609830|Behavioral|No Information|Participants received no informational materials.
11997741|NCT00609817|Drug|GCS-100|GCS-100 160mg/m2 IV (in the vein) on Study Days 1, 4, 8 and 11 for up to 12 consecutive 21-day treatment cycles. Three patients will be assigned to each cohort until maximum tolerated dose is reached. The dose levels: 1) 160 mg/m2; 2) 210 mg/m2; 3) 280 mg/m2; 4) 370 mg/m2
11997742|NCT00609817|Drug|Bortezomib/Dexamethasone|Bortezomid 1.3 mg/m2 and dexamethasone 20 mg/day plus an additional 20 mg of dexamethasone on the day following each of the GCS-100/bortezomib and dexamethasone dosing. GCS-100/bortezomib and dexamethasone dosed on Study Days 1, 4, 8 and 11 of each 21-day cycle after disease progression is noted.
11997743|NCT00609804|Drug|Sorafenib|Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
11997744|NCT00609804|Drug|Erlotinib|Erlotinib 150 mg once daily by mouth
11997745|NCT00609791|Drug|paclitaxel albumin-stabilized nanoparticle formulation|100 mg/m2 3 weeks on 1 week off
11997863|NCT00609063|Drug|Atorvastatin|80-mg atorvastatin capsules taken daily for 6 months
11997746|NCT00609791|Other|pharmacological study|Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours
11997747|NCT00609791|Other|physiologic testing|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
11997748|NCT00609791|Other|questionnaire administration|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
11997749|NCT00609791|Other|study of socioeconomic and demographic variables|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
11997750|NCT00609791|Procedure|cognitive assessment|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
11997751|NCT00609791|Procedure|psychosocial assessment and care|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
11997752|NCT00609778|Device|LUCAS|Mechanical chest compression
11997753|NCT00609778|Other|Conventional manual resuscitation method|Manual compression
11997754|NCT00609765|Drug|Avastin|Every 28 Days: Avastin 5mg/kg iv days 1 and 15
11997755|NCT00609765|Drug|Fluorouracil|Every 28 Days: Fluorouracil 400mg/m^2 iv bolus daily days 1-5
11997756|NCT00609765|Drug|Doxorubicin|Every 28 Days: Doxorubicin 40mg/m^2 iv bolus day 1
11997757|NCT00609765|Drug|Streptozocin|Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5
11997758|NCT00609765|Drug|Dexamethasone|Premedication: Dexamethasone 20mg intravenously days 1-5
11997759|NCT00609765|Drug|Ondansetron|Premedication: Ondansetron 16mg intravenously days 1-5
11997760|NCT00609752|Drug|prednisolone|Standard treatment regimens based on body weight will be used (approximately 2 mg per kg), with a stepwise dose reduction over a 10-14 week period.
11997761|NCT00609752|Dietary Supplement|Alicalm (polymeric liquid formula)|"Subjects will receive all of their nutritional requirements in the form of a nutritionally balanced polymeric feed, volume based on EAR for age. Duration of 5 to 8 weeks with subjects returning to a normal unrestricted diet by 10 weeks."
11997762|NCT00609739|Drug|cyclosporine|Patients will receive CSA therapy beginning on day -3, with a taper commencing on day +60 (unless GVHD) and ending on day +90. For patients >40 kg with normal renal function (creatinine <1.3 mg/dL), the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children <40 kg, the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.
11997763|NCT00609739|Drug|cytarabine|3000 mg/m^2 intravenously (IV) over 2 hours x 2 (i.e. total 6000 mg/m^2/day) on days -9 through -4.
11997764|NCT00609739|Drug|filgrastim|Patients with absolute neutrophil count (ANC) <0.2 x 10^8/L on day 21 may receive G-CSF at 5 mcg/kg/day. G-CSF will be continued until ANC ≥2.5 x 10^8/L for two consecutive days. As the malignant cell population of JMML is known to be hypersensitive to GM-CSF, this cytokine will not be given to these patients.
11997765|NCT00609739|Drug|methotrexate|MTX will be administered to recipients of non-genotypically identical BMT. MTX will be administered at a dose of 15 mg/m^2 (based on adjusted ideal body weight) intravenously (IV) on day +1 and at a dose of 10 mg/m^2 IV on days +3, +6, and +11.
11997766|NCT00609739|Drug|methylprednisolone|Recipients of UCB will receive methylprednisolone 2 mg/kg/day from day +5 to +19 at a dose of 1 mg/kg twice a day (bid) with a 10% taper every week thereafter.
11997767|NCT00609739|Drug|mitoxantrone hydrochloride|10 mg/m^2 over 30 minutes intravenously (IV) on days -9 through -7.
11997768|NCT00609739|Procedure|allogeneic bone marrow transplantation|Donor marrow will be collected in the usual sterile manner with a collection goal of 2.0 >10^8/kg recipient weight. Infused on Day 0.
11997769|NCT00609739|Procedure|umbilical cord blood transplantation|Umbilical cord blood (UCB) will be cryopreserved prior to transplantation. Cord blood units will be selected for transplantation according to current University of Minnesota Department of Blood and Marrow Transplantation Guidelines.
11997770|NCT00609739|Drug|Cis-Retinoic acid|Post-Transplant Cis-Retinoic Acid (CRA) Therapy - CRA will be given at a dosage of 100 mg/m^2/day by mouth in a single daily dose starting on day +60 and continuing until 1 year after transplant.
11997771|NCT00609713|Behavioral|Comprehensive behavioral weight control program|Participants will meet weekly for 12 weeks, then every other week for 12 weeks, and once a month thereafter through week 52. Adolescents and parents will receive manuals that provide lessons and homework assignments for each meeting. The program for the first 22 weeks includes the following topics: 1) the causes of obesity; 2) components of healthy nutrition; 3) self-monitoring of calories, physical activity, and inactivity; 4) stimulus control procedures; 5) coping with high-risk social or psychological situations that trigger excess eating; 6) increasing physical activity; and 7) minimizing inactivity. At each session, participants will submit their self-monitoring diaries and completed homework. Incentives for completion of self-monitoring tasks are an integral part of the behavior modification program and a small gift certificate will be given to subjects for successful completion at each intervention session.
11997772|NCT00609713|Other|Individual 12-month nutrition education program|The other half of the participants (44 subjects) will be randomized to this arm of the intervention (usual care), which will also start in five waves. In contrast to the comprehensive behavioral weight control program, the nutrition education program will take place through individual appointments with a clinical dietician to reflect usual care and mimic the present approach used for the treatment of obese adolescents at the Children's Hospital of Philadelphia (CHOP) Nutrition Consultation. Parents will be required to take part in the consultations. The first consultation will last 60 minutes and the following consultations of 30 minutes will take place once a month for the first six months, then every other month for the second six months, as is the usual practice in our clinical setting.
11997773|NCT00609687|Procedure|Diagnostic Vitrectomy|"Three-port, 20-gauge pars plana vitrectomy instrumentation was utilized. An infusion line was inserted into one sclerotomy and secured to the globe. A second sclerotomy was made, and a fiberoptic light pipe was immediately inserted to minimize vitreous egress. A third sclerotomy was created, and the vitreous cutter was inserted. To obtain an undiluted vitreous sample, the vitreous was cut mechanically with the vitreous cutter, while the assistant surgeon simultaneously manually aspirated the vitreous. After sufficient undiluted sample was obtained, infusion fluid was allowed to enter the eye and a diluted vitreous sample was obtained in a similar manner. The samples were personally carried to the clinical laboratories by the operating surgeon.
~Vitreous fluid analysis was guided by clinical suspicion based on the pre-operative differential diagnosis and the intraoperative posterior segment appearance."
11997774|NCT00609674|Drug|Fluticasone furoate nasal spray|Fluticasone furoate nasal spray
11997775|NCT00609674|Drug|Placebo|Placebo
11997776|NCT00609648|Behavioral|Computer Assisted Relaxation Learning|A self-paced computer program for reducing dental injection fear.
11997777|NCT00609648|Behavioral|Pamphlet|A pamphlet reassuring patients about dental injections.
11997778|NCT00609622|Drug|sunitinib|Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).
11997779|NCT00609622|Drug|mFOLFOX6|FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
11997780|NCT00609622|Drug|bevacizumab|Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.
11997781|NCT00609622|Drug|mFOLFOX6|FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
11997782|NCT00609609|Procedure|Photopheresis|8-9 photopheresis treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60. After day 60, your doctor will decide whether ECP is worth continuing, and the frequency of treatments.
11997783|NCT00609609|Drug|Methylprednisolone|2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.
11997784|NCT00609596|Drug|GI198745|
11997785|NCT00609570|Dietary Supplement|NanoGreens|fruits and vegetables
11997786|NCT00609570|Dietary Supplement|Whey protein|Whey
11997787|NCT00609570|Dietary Supplement|Calcium pills|CA
11997788|NCT00609557|Drug|duloxetine|Weeks 0-2 placebo Weeks 2-3 30mg duloxetine Weeks 3-4 60mg duloxetine Weeks 4-12 60-90mg duloxetine Week 13 30 mg duloxetine Week 14 stop
11997789|NCT00609544|Drug|Rilonacept|Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
11997790|NCT00609531|Drug|Citalopram|Pill, 5-20mg once a day for twelve weeks
11997791|NCT00609531|Drug|Placebo|Placebo pill once a day for twelve weeks
11997792|NCT00609518|Drug|pemetrexed|500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.
11997793|NCT00609518|Dietary Supplement|Folic acid|350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.
11997794|NCT00609518|Dietary Supplement|Folic Acid|350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.
11997795|NCT00609518|Dietary Supplement|Vitamin B12|1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
11997796|NCT00609518|Drug|dexamethasone|4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.
11997797|NCT00609518|Drug|dexamethasone|4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.
11997798|NCT00609505|Other|Telemedicine|Telemedicine genetic counseling
11997799|NCT00609505|Other|Face-to-Face|Face-to-face genetic counseling
11997800|NCT00609492|Biological|GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)|Single dose, intramuscular injection
11997801|NCT00609492|Biological|Infanrix™-IPV/Hib|Single dose, intramuscular injection
11997802|NCT00609479|Procedure|Osteosynthesis|"Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12.
~Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12."
11997803|NCT00609466|Drug|CG5503 IR|75mg IR 4 - 6 hourly Total: 72 hours
11997804|NCT00609466|Drug|Morphine|Morphine 30 mg IR 4 - 6 hourly Total: 72 hours
11997805|NCT00609466|Drug|Placebo|Placebo; 4 - 6 hourly; Total: 72 hours
11997806|NCT00609453|Behavioral|Brief Behavioral Activation Treatment for Depression|Weekly individual therapy sessions
11997807|NCT00609440|Other|physiotherapeutic treatment|At first, the patient was submitted to a conventional physiotherapeutic treatment and respiratory exercises; then, we gave emphasis to the motor development marks and to the march training; eventually, the kid was conducted to hydrotherapy.
11997808|NCT00609427|Behavioral|MEMO programme (Inst Universitaire de Geriatrie, Montreal)|8 weekly group training sessions in mnemonic strategies, administered by clinical psychologist.
11997809|NCT00609427|Behavioral|External memory aids training|8 weekly group sessions of training in the use of external memory aids, administered by clinical psychologist
11997810|NCT00609401|Drug|Nexavar (Sorafenib)|400 mg bid
11997811|NCT00609401|Drug|IL-2|IL-2 3 MU per 5 day/week for 2 weeks every 4
11997812|NCT00609388|Drug|Tacrolimus|Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL
11997813|NCT00609388|Other|Saline solution 0.9% (250mL)|intraoperative intraportal infusion of Saline solution 0.9% (250mL)
11997814|NCT00609375|Drug|cefepime|Administration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours.
11997815|NCT00609375|Drug|cefepime|Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours
11997816|NCT00609362|Drug|Rosiglitazone|one tablet of rosiglitazone 8 milligrams per day for 14 weeks
11997817|NCT00609362|Drug|Placebo pill|One encapsulated placebo pill a day for 14 weeks
11997864|NCT00609063|Drug|Placebo|Placebo capsules taken daily for 6 months
11997908|NCT00608738|Procedure|assessment of therapy complications|
11997909|NCT00608738|Procedure|management of therapy complications|
11997818|NCT00609349|Device|ETED, CPET, RHC|"exercise tricuspid echo doppler (ETED): allows the estimation of systolic pulmonary arterial pressure at exercise cardiopulmonary exercise test (CPET) allows to measures exercise capacity (peakVO2)
~right heart catheterisation (RHC): is the gold standard for the measurement of pulmonary arterial pressure values"
11997819|NCT00609336|Drug|gemcitabine hydrochloride|Given IV
11997820|NCT00609336|Drug|docetaxel|Given IV
11997821|NCT00609336|Drug|capecitabine|Given PO
11997822|NCT00609336|Radiation|intensity-modulated radiation therapy|Undergo IMRT
11997823|NCT00609336|Drug|oxaliplatin|Given IV
11997824|NCT00609336|Procedure|pancreatic surgical procedure|Undergo pancreaticoduodenectomy
11997825|NCT00609336|Procedure|therapeutic conventional surgery|Undergo therapeutic conventional surgery
11997826|NCT00609336|Other|laboratory biomarker analysis|Correlative studies
11997827|NCT00609323|Drug|lidocaine and tetracaine cream 7%/7%|One treatment of up to 400 cm2 Cream applied for 60 minutes.
11997828|NCT00609323|Drug|Placebo|One treatment of up to 400 cm2 Cream applied for 60 minutes.
11997829|NCT00609310|Dietary Supplement|Flavonoids|Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day
11997830|NCT00609297|Other|medical chart review|The Research Nurse will conduct a chart review after the patient's death.
11997831|NCT00609297|Other|questionnaire administration|The questionnaires will be completed at the end of week 1, week 2 and week 4.
11997832|NCT00609297|Other|survey administration|Given to patient and caregivers throughout the study
11997833|NCT00609284|Drug|cetuximab|D-7, D1, D8, D15, D22, D29, D43, D50
11997834|NCT00609284|Drug|Carboplatin, 5FU concomitant|Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46
11997835|NCT00609284|Radiation|Radiotherapy|70 Gy in 7 weeks
11997836|NCT00609271|Behavioral|low carbohydrate diet|<40 grams carbohydrate/day
11997837|NCT00609271|Behavioral|low fat diet|<30% fat, <7% saturated fat
11997838|NCT00609245|Drug|Valproic Acid|The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
11997839|NCT00609245|Drug|Placebo|Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
11997840|NCT00609219|Biological|autologous EBV specific CTLs|"30-40cc of peripheral blood will be used to generate EBV specific CTLs
~Group One:
~Day 0 - 2 x 10^7 cells/m2 Day 14 - 2 x 10^7 cells/m2
~Group Two:
~Day 0 - 2 x 10^7 cells/m2 Day 14 - 1 x 10^8 cells/m2
~Group Three:
~Day 0 - 1 x 10^8 cells/m2 Day 14 - 2 x 10^8 cells/m2"
11997841|NCT00609193|Drug|lithium|standard clinical care
11997842|NCT00609193|Drug|quetiapine|standard clinical care
11997843|NCT00609180|Behavioral|Minimal (Trophic) Feeding|Enteral feeds will be started at 10 cc per hour and continued at this rate for 144 hours. After 144 hours of trophic enteral feeds, the feeding rate will be advanced to full-calorie rates, which will continue for the duration of mechanical ventilation up to Day 28.
11997844|NCT00609180|Behavioral|Full Feeding|Upon admission to the ICU, a full-calorie feeding rate will be determined, which will be calculated to deliver 25 to 35 kcal/kg predicted body weight (PBW) each day. Enteral feeds will be initiated at 25 cc per hour. The feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is achieved, which will be administered for the duration of mechanical ventilation up to Day 28.
11997845|NCT00609180|Dietary Supplement|Omega-3 Fatty Acids and Antioxidant Supplements|Omega-3 fatty acids, GLA, and antioxidants will be administered through a feeding tube every 12 hours as a 120-cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.
11997846|NCT00609180|Dietary Supplement|Placebo|The study placebo will be administered through a feeding tube every 12 hours as a 120 cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.
11997847|NCT00609167|Drug|bortezomib|"First 33 patients: 1.3 mg/m^2 IV Days 1, 4, 8 & 11
~Remaining 30 patients: 1.5 mg/m^2 IV Days 1, 8, 15 & 22"
11997848|NCT00609167|Drug|cyclophosphamide|300mg/m^2 PO days 1, 8, 15 & 22
11997849|NCT00609167|Drug|dexamethasone|"First 33 patients: 40 mg PO Days 1-4, 9-12, 17-20
~Remaining 30 patients: 40 mg PO Days 1-4, 9-12, 17-20 for cycles 1-2; Days 1, 8, 15, 22 for cycle 3+2 for cycle 3 and beyond"
11997850|NCT00609154|Drug|glucagon like peptide-1|GLP-1 1 pmole/kg/min
11997851|NCT00609154|Drug|glucose control|glucose without GLP-1
11997852|NCT00609141|Biological|cixutumumab|Given IV
11997853|NCT00609141|Other|pharmacological study|Correlative studies
11997854|NCT00609141|Other|laboratory biomarker analysis|Correlative studies
11997855|NCT00609128|Drug|olopatadine|olopatadine one drop in one eye for one week
11997856|NCT00609115|Device|AMES device|Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
11997857|NCT00609115|Device|AMES device (sham)|Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.
11997858|NCT00609115|Device|AMES device|Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.
11997859|NCT00609102|Drug|Placebo|one capsule BID
11997860|NCT00609102|Drug|n-aceylcysteine|450 mgm BID
11997861|NCT00609089|Behavioral|CRAFT-T|The Community Reinforcement and Family Training for Treatment Retention and HIV Risk Reduction treatment (CRAFT-T) was be developed in phase 1 and 2 of the current study and consists of twelve manual-guided weekly one-hour individual sessions for the concerned significant other and 2 one hour sessions for the identified patient. The intervention also allows for up to two additional sessions (total of 14 visits) to help arrange re-entry into substance abuse treatment when needed. The identified patient receives this intervention in addition to the usual services at the drug treatment program (Maryhaven).
11997862|NCT00609089|Behavioral|Treatment as usual|Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.
11997865|NCT00609050|Behavioral|Self-Regulated Exercise with Telephone Reinforcement|The self-regulated exercise with telephone reinforcement group will engage in a three-times-a-week (or more) at home exercise regimen for 6 months during which they may choose the mode of exercise. They will receive weekly telephone calls about exercise and airway clearance. After 6 months, they will be instructed to maintain their self-regulated exercise activity for the remaining 6 months of the study, but they will not receive telephone calls
11997866|NCT00609050|Behavioral|Standard Treatment|The attention control group will receive standard recommendations for exercise activity, during the first 6 months, as is common in our clinic. Also during the first 6 months, they will receive weekly telephone calls about airway clearance. For the final 6 months of the study, the attention control group will cross over to self-regulated exercise without telephone reinforcement.
11997867|NCT00609050|Behavioral|Qualitative Approach|A qualitative naturalistic approach is nested within the primary experimental framework to explore the experiences of the children and parents, in both groups, with the exercise regimen.
11997868|NCT00609011|Drug|MPC-6827 + Temozolomide|MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Temozolomide at 85 mg/m2 administered orally daily for 21 days in a 4 week cycle.
11997869|NCT00608985|Drug|almorexant|2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
11997870|NCT00608985|Drug|almorexant|1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
11997871|NCT00608985|Drug|Placebo|2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
11997872|NCT00608985|Drug|zolpidem|2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
11997873|NCT00608972|Drug|Doxil|Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
11997874|NCT00608972|Drug|Carboplatin|Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
11997875|NCT00608972|Drug|Bevacizumab|Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
11997876|NCT00608959|Drug|omiganan 1% gel|"Omiganan 1% gel will be applied to 6 sites on the chest and/or abdomen.Swab cultures will be obtained at specified timepoints over a period of 3 days (Part1) or 7 days (Part 2).
~In addition, subjects in Part 2 will have omiganan 1% gel applied to one intravenous (IV) catheter site."
11997877|NCT00608959|Drug|chlorhexidine 2% solution|"Part 1- chlorhexidine 2% solution will be applied to 6 sites on the chest and/or abdomen. All application sites will be covered with semi-transparent dressings.Swab cultures will be obtained at specific timepoints over a period of 3 days.
~Part 2: Subjects in Part 2 will have chlorhexidine 2% solution applied to one intravenous (IV) catheter site only."
11997878|NCT00608946|Dietary Supplement|copper|intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status
11997879|NCT00608946|Dietary Supplement|placebo|placebo
11997880|NCT00608933|Other|educational intervention|Health providers receive educational materials comprising a brief video about communicating with and providing guidance to patients regarding complimentary and alternative medicine (CAM) and a list of resources they can access to obtain information about herbs, CAM modalities, and drug/herb interactions. Approximately 2 weeks after the educational intervention, health providers receive a follow-up e-mail reminding them to ask patients about CAM use. The e-mail also includes a brief update regarding current research findings on CAM modalities and drug/herb interactions.
11997881|NCT00608933|Other|questionnaire administration|Patients complete questionnaires
11997882|NCT00608920|Other|Single Photon Emission Computed Tomography (SPECT)|
11997883|NCT00608907|Drug|bortezomib|1.3 mg/m^3 on days 1, 4, 8, 11 over a 21-day treatment cycle
11997884|NCT00608907|Drug|bortezomib, rifampicin|bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3
11997885|NCT00608907|Drug|bortezomib, dexamethasone|bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3
11997886|NCT00608894|Drug|LCP-Tacro (tacrolimus)|LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
11997887|NCT00608894|Drug|Azathioprine|Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
11997888|NCT00608881|Drug|coenzyme Q10|4 - 300 mg CoQ chewable wafers taken orally twice a day
11997889|NCT00608881|Other|placebo|an inactive substance
11997890|NCT00608868|Drug|Gefitinib|Gefitinib tablet 250mg once daily orally
11997891|NCT00608855|Other|questionnaire administration|
11997892|NCT00608855|Procedure|cryosurgery|
11997893|NCT00608855|Procedure|pain therapy|
11997894|NCT00608855|Procedure|quality-of-life assessment|
11997895|NCT00608842|Drug|Deoxycholic Acid Injection|Administered via intralipomal injection.
11997896|NCT00608842|Drug|Placebo|Matching vehicle placebo administered via intralipomal injection.
11997897|NCT00608829|Device|GORE TAG® Thoracic Endoprosthesis|Implant
11997898|NCT00608816|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2
11997899|NCT00608816|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infusion during two hour experimental period on Day 2
11997900|NCT00608803|Drug|ZIO-201-T and doxorubicin|ZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.
11997901|NCT00608790|Drug|Salbutamol|Prophylactic salbutamol administered at a dose of 200 micrograms by metered dose inhaler (MDI) via a spacer.
11997902|NCT00608790|Drug|Sodium chloride 5%|30 ml sterile hypertonic saline solution (sodium chloride 5%) will be administered by jet nebulisation for 15-20 minutes.
11997903|NCT00608777|Drug|Calcipotriene/betamethasone|One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.
11997904|NCT00608751|Radiation|IMRT|
11997905|NCT00608738|Other|informational intervention|
11997906|NCT00608738|Other|medical chart review|
11997907|NCT00608738|Other|questionnaire administration|
11997910|NCT00608725|Radiation|DAXOR|131-I-Human Serum Albumin Blood Volume Assessment Kit
11997911|NCT00608725|Procedure|QSweat|Quantitative Sweat Testing
11997912|NCT00608725|Drug|Intrinsic Heart Rate|Atropine 0.04 mg/kg IV in divided doses Propranolol 0.2 mg/kg IV in divided doses
11997913|NCT00608712|Drug|Esomeprazole|Esomeprazole 20mg oral tablet
11997914|NCT00608699|Drug|GSK256073A tablets + IR niacin tablets|single dosing for 4 to 5 sessions
11997915|NCT00608686|Dietary Supplement|Pregnenolone|30mg of pregnenolone administered orally, once, at 2 of 5 study visits.
11997916|NCT00608673|Drug|Pimecrolimus 1% cream|a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus
11997917|NCT00608673|Drug|betamethasone valerate 0.1% cream|A very thin coat of betamethasone valerate 0.1% cream, twice daily to facial lesions of discoid lupus erythematosus for 8 weeks.
11997918|NCT00608660|Other|acupuncture|staging acupuncture
11997919|NCT00608660|Other|acupuncture and moxibustion|staging acupuncture and moxibustion
11997920|NCT00608660|Other|electroacupuncture|staging electroacupuncture
11997921|NCT00608660|Other|acupuncture along yangming tendons|staging acupuncture along Yangming musculature
11997922|NCT00608660|Other|acupuncture|non-staging acupuncture
11997923|NCT00608634|Drug|perillyl alcohol|Applied as topical cream
11997924|NCT00608634|Other|placebo|Applied as topical cream
11997925|NCT00608595|Drug|celecoxib|Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
11997926|NCT00608595|Genetic|gene expression analysis|not noted
11997927|NCT00608595|Genetic|protein expression analysis|Not noted
11997928|NCT00608595|Other|immunohistochemistry staining method|not noted
11997929|NCT00608595|Other|laboratory biomarker analysis|not noted
11997930|NCT00608595|Other|mass spectrometry|
11997931|NCT00608595|Procedure|biopsy|At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
11997932|NCT00608595|Procedure|neoadjuvant therapy|not noted
11997933|NCT00608595|Procedure|therapeutic conventional surgery|not noted
11997934|NCT00608582|Device|Transcranial Magnetic Stimulation, Repetitive|10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
11997935|NCT00608569|Drug|Lopinavir/ritonavir|Two tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily
11997936|NCT00608569|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily
11997937|NCT00608569|Drug|Tenofovir disoproxil fumarate|300-mg tablet taken orally once daily
11997938|NCT00608569|Drug|Zidovudine|300-mg tablet taken orally twice daily
11997939|NCT00608569|Drug|Emtricitabine|200-mg tablet taken orally once daily
11997940|NCT00608543|Drug|Aripiprazole|varied dose (5, 10, 15 mg qd) for 6 wks
11997941|NCT00608530|Behavioral|Cognitive Behavioral Therapy-Psychologist-Delivered|Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a psychologist
11997942|NCT00608530|Behavioral|Supportive Psychotherapy-Psychologist-Delivered|Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was administered by a psychologist
11997943|NCT00608530|Behavioral|Cognitive Behavioral Therapy Nurse-Delivered|Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a nurse
11997944|NCT00608530|Behavioral|Supportive Psychotherapy-Nurse-Delivered|Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian Therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was delivered by a nurse
11997945|NCT00608517|Biological|anti-thymocyte globulin|Given IV
11997946|NCT00608517|Drug|cyclophosphamide|Given IV
11997947|NCT00608517|Drug|fludarabine phosphate|Given IV
11997948|NCT00608517|Drug|methylprednisolone|Given IV
11997949|NCT00608517|Radiation|total-body irradiation|Given daily for 1-4 days
11997950|NCT00608491|Drug|Stepped pharmacologic care|Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.
11997951|NCT00608491|Device|Ultrafiltration|All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy.
11997952|NCT00608465|Drug|Eplerenone|5 mg x 1 week followed by 10 mg x 9 weeks.
11997953|NCT00608465|Drug|Ramipril|Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks.
11997954|NCT00608452|Other|Symptom Assessment Scale|"Memorial Symptom Assessment Scale
~History and neurologic examination"
11997955|NCT00608439|Drug|Centella asiatica selected triterpenes (CAST)|Drug provided to subjects in 60 mg capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated dose from week 12 to 52.
11997956|NCT00608439|Other|Placebo|"Placebo provided to subjects in 60 mg color-matched capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated dose from week 12 to 52."
11997957|NCT00608426|Behavioral|Proactive Outreach with choice of telephone or in-person smoking cessation services|This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
11997958|NCT00608400|Dietary Supplement|Clarinol CLA|0, 1.5 or 3.0 g/d dietary conjugated linoleic acids glycerides for 4 months, capsule form
11997959|NCT00608387|Behavioral|Chronic disease management Web-based software|Participants will have access to remotely based medical providers through the use of the Web-based software.
11997960|NCT00608374|Drug|chlorambucil|
11997961|NCT00608374|Drug|fludarabine phosphate|
11997962|NCT00608374|Procedure|quality-of-life assessment|
11997963|NCT00608361|Drug|Dasatinib|Given PO
11997964|NCT00608361|Other|Pharmacological Study|Correlative studies
11997965|NCT00608348|Procedure|Hyperinsulinemic glucose clamp procedures|2 hours of either euglycemic or hypoglycemic glucose clamping
11997966|NCT00608348|Procedure|moderate exercise|90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia
11997967|NCT00608335|Drug|Micafungin|IV
11997968|NCT00608322|Drug|Inhaled nitric oxide|Inhaled nitric oxide, 40 parts per million, for six hours.
11997969|NCT00608322|Other|Sham inhaled nitric oxide|Sham inhaled nitric oxide administration, 0 parts per million, for six hours.
11997970|NCT00608244|Drug|LCP Tacro|"In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.
~LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses.
~Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL."
11997971|NCT00608244|Drug|Prograf|Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.
11997972|NCT00608231|Drug|Dexmedetomidine Hydrochloride Infusion|Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
11997973|NCT00608231|Drug|Normal Saline|Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
11997974|NCT00608218|Drug|Ciclesonide|This is an observational study. Therefore, the physician decides about dosage according to individual needs.
11997975|NCT00608205|Drug|cisplatin|Given IV
11997976|NCT00608205|Drug|fluorouracil|Given IV
11997977|NCT00608205|Radiation|radiation therapy|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
11997978|NCT00608192|Behavioral|Testing, Education, & Counseling (TEC)|Trained research staff will provide a two-session HIV/hepatitis education class. Participants will also be offered serological testing for hepatitis A, B and C, and HIV (optional), and off-site referrals for vaccination and hepatitis care. The content of the TEC intervention is evidence based. The TEC condition is comparable to screening and education methods commonly used in many drug treatment settings. Those in the TEC intervention group who do not adhere to needed off site vaccinations will be offered on site vaccination 30 days after vaccination referral.
11997979|NCT00608192|Behavioral|Hepatitis Care Coordination (HCC)|HCC Participants will be offered serological testing and counseling for hepatitis A, B and C, and HIV (optional). HCC participants will be offered on-site hepatitis A and B combination vaccination at the methadone clinic. They will also receive a two-session HIV/hepatitis education class with Motivational Interviewing. In addition, participants will receive 6 months of weekly case management to facilitate entry into hepatitis care.
11997980|NCT00608179|Drug|Glimepiride|Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
11997981|NCT00608179|Drug|glyburide|Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
11997982|NCT00608179|Other|glucose clamp|Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
11997983|NCT00608179|Other|glucose clamp|hypoglycemic glucose clamp procedure -120 minutes
11997984|NCT00608140|Procedure|Surgical mitral valvuloplasty with placement of annular ring (SMVR)|Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. The ring size will be between 24 mm and 27 mm in the anteroposterior diameter. Annular ring sutures will be placed circumferentially approximately 1 mm off the hinge point between the leaflet and the atrial tissue. The total number of sutures will vary between 4 and 7 sutures anteriorly, while 8 to 12 sutures will be utilized for the posterior segment of the annulus. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
11997985|NCT00608140|Drug|Optimal medical therapy (OMT)|Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.
11997986|NCT00608127|Device|LupusorbTM|Single treatment
11997987|NCT00608101|Drug|Fludrocortisone|Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
11997988|NCT00608101|Drug|Dexamethasone|Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1
11997989|NCT00608088|Behavioral|Usual Care|"The usual care group will received standard care from the Johns Hopkins Hospital lactation consultant and nurses, which may have included a visit in the hospital by the lactation consultant if mothers delivered Monday through Friday. The lactation consultant was also available by request. A warm-line was also standard. This was a telephone line that was connected to an answering machine; the lactation consultant checked this line once daily (Monday through Friday) and returned calls."
11997990|NCT00608088|Behavioral|Community Health Nurse/Peer Councelor Team|"Visits by a community health nurse/peer counselor team during the first six postpartum months. Based on prior research and experience, the team was developed to provide culturally relevant support and health-care education to low-income mothers, who were a high percentage of African American women. The goals of this team were to 1) increase the duration of breastfeeding while emphasizing ways to decrease fatigue, and decrease breast discomfort; 2) strengthen maternal competence with breastfeeding and commitment to breastfeeding; 3) provide parent education about the infant regarding breastfeeding; 4) provide/find social support needed for continued breastfeeding; and 5) foster linkages to community services that will facilitate the maintenance of breastfeeding.
~The specific activities of the CHN/peer counselor team included hospital visitation after enrollment, home visiting during the first postpartum month, and telephone support throughout the first six postpartum months."
11997991|NCT00608075|Drug|lithium|600 mg - 1800 mg per day
11997992|NCT00608075|Drug|Lithium|600 - 1800 mg
11997993|NCT00608062|Drug|GnRHant - Ganirelix acetate|1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7
11997994|NCT00608062|Drug|Transdermal estradiol patch|0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)
11997995|NCT00608062|Drug|Transdermal placebo patch|Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)
11997996|NCT00608049|Behavioral|High carbohydrate and low glycemic index (GI) diet|The high carbohydrate and low GI diet will require 58% of daily calories to be from carbohydrates and will be composed of meals with a GI of less than 45 on the glucose scale.
11997997|NCT00608049|Behavioral|Low carbohydrate and low GI diet|The low carbohydrate and low GI diet will require 40% of daily calories to be from carbohydrates and will be composed of meals with a GI of less than 45 on the glucose scale.
11997998|NCT00608049|Behavioral|High carbohydrate and high GI diet|The high carbohydrate and high GI diet will require 58% of daily calories to be from carbohydrates and will be composed of meals with a GI of greater than 65 on the glucose scale.
11997999|NCT00608049|Behavioral|Low carbohydrate and high GI diet|The low carbohydrate and high GI diet will require 40% of daily calories to be from carbohydrates and will be composed of meals with a GI of greater than 65 on the glucose scale.
11998000|NCT00608023|Drug|Tesamorelin|
11998001|NCT00608023|Drug|Placebo for Tesamorelin|
11998002|NCT00608010|Procedure|Vitrification|Embryos were vitrified according to a previously described technique
11998003|NCT00608010|Procedure|Slow freezing|Embryos were frozen with slow freezing technique
11998004|NCT00607997|Drug|vosaroxin|Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.
11998005|NCT00607984|Drug|thiotepa melphalan|thiotepa 900 mg per meter squared total, on days -11,-10,-4,-3 melphalan 140 mg per meter squared total on days -11,-10,-4,-3 autologous stem cell transplant in day 0
11998006|NCT00607971|Drug|Renzapride|All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52
11998007|NCT00607958|Drug|tipranavir/ritonavir (dose reduction)|tipranavir/ritonavir 500/100 BID
11998008|NCT00607945|Drug|Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant|Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
11998009|NCT00607945|Dietary Supplement|conjugated linoleic acid (CLA)|3.2 g/day, capsule, week 0 to week 32
11998010|NCT00607945|Dietary Supplement|conjugated linoleic acid (CLA)|6.4 g/day, capsule, week 0 to week 32
11998011|NCT00607932|Behavioral|behavioral dietary intervention|
11998012|NCT00607932|Dietary Supplement|Brassica vegetable|
11998013|NCT00607932|Drug|indole-3-carbinol|follow up at 2,4,6 months post baseline.
11998014|NCT00607932|Other|counseling intervention|2, 4, 6 months post baseline
11998015|NCT00607932|Other|medical chart review|2,4,6 months post baseline
11998016|NCT00607932|Other|questionnaire administration|
11998017|NCT00607932|Procedure|adjuvant therapy|
11998018|NCT00607919|Drug|Atomoxetine|Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks
11998019|NCT00607919|Drug|Placebo|oral, daily, for 16 weeks
11998020|NCT00607906|Drug|SB-756050 immediate release capsule|SB-756050 immediate release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white drug layered pellets. Each capsule will contain 5, 25 or 100 milligrams of SB-756050.
11998021|NCT00607906|Drug|SB-756050 modified release capsule|SB-756050 modified release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white enteric coated drug layered pellets. Each capsule will contain either 25or 100 milligrams of SB-756050.
11998022|NCT00607906|Drug|Placebo|Subjects will also receive placebo capsules.
11998023|NCT00607893|Device|Continuous Positive Airway Pressure (CPAP)|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
11998024|NCT00607893|Device|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
11998025|NCT00607880|Procedure|vascular access device placement|
11998026|NCT00607867|Other|LoBAG30 diet|A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
11998027|NCT00607867|Other|Control Diet|A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
11998028|NCT00607854|Drug|Ibritumomab Tiuxetan (Zevalin)|"Conditioning regimen followed by allogeneic hematopoietic stem cell transplantation.
~Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)"
11998029|NCT00607841|Drug|Ispinesib|10 mg/m2 dose as a 1-hour intravenous infusion.
11998030|NCT00607841|Drug|Ispinesib|12 mg/m2 dose as a 1-hour intravenous infusion.
11998031|NCT00607841|Drug|Ispinesib|14 mg/m2 dose as a 1-hour intravenous infusion.
11998032|NCT00607828|Radiation|stereotactic body radiation therapy|Undergo radiotherapy
11998033|NCT00607815|Behavioral|Cognitive Processing Therapy|CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
11998078|NCT00607412|Behavioral|12-step based supportive therapy|supportive psychotherapy based on 12-step model
11998079|NCT00607399|Drug|SGX523 Capsules|This is a dose escalation study
11998080|NCT00607386|Biological|Idursulfase|Solution for intravenous infusion, 0.5 mg/kg weekly
11998034|NCT00607815|Behavioral|Present Centered Therapy|"Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
11998035|NCT00607802|Biological|leukocyte therapy|
11998036|NCT00607802|Genetic|polymerase chain reaction|
11998037|NCT00607789|Drug|Duloxetine|30 mg/day - 120 mg/day
11998038|NCT00607789|Drug|Placebo|identical to study drug
11998039|NCT00607776|Drug|(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400|Drops
11998040|NCT00607776|Drug|Systane|Drops
11998041|NCT00607763|Drug|Micafungin (Mycamine)|IV
11998042|NCT00607750|Drug|ATG003 (mecamylamine)|1% Ophthalmic solution, eyedrop BID, 48 weeks
11998043|NCT00607750|Drug|Placebo|Placebo eyedrops, BID, 48 weeks
11998044|NCT00607737|Drug|insulin detemir|3 cutaneous injections
11998045|NCT00607737|Drug|saline|3 cutaneous injections
11998046|NCT00607724|Drug|GDC-0449|
11998047|NCT00607711|Drug|oral palifosfamide tris|Capsule(s) given daily for 15 days followed by a 6 day rest. This is a dose escalation arm.
11998048|NCT00607685|Drug|5 Fluorouracil with hyaluronic acid|Participants will receive a subconjunctival injection of 0.1ml of a mixure of 5 Fluorouracil (50mg/ml) with hyaluronic acid (23mg/ml) once at enrollment into the study.
11998049|NCT00607685|Drug|5 Fluorouracil|Pariticpants will receive a subconjunctival injection of 0.1ml of 5 Fluorouracil 50mg/ml once at enrollment
11998050|NCT00607672|Drug|Placebo|Placebo
11998051|NCT00607672|Drug|Ramipril|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
11998052|NCT00607672|Drug|Candesartan|Candesartan 16mg/d
11998053|NCT00607659|Other|No intervention, only observational|No intervention, only observational
11998054|NCT00607646|Drug|Dehydroepiandrosterone|Placebo tablets or tablets containing DHEA will be given orally before each hyperinsulinemic clamps on day 1 (x 2). Placebo tablets or tablets containing DHEA will be given orally before Day 2 hyperinsulinemic hypoglycemic clamp x 1.
11998055|NCT00607646|Drug|Placebo|Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
11998056|NCT00607620|Behavioral|Brief Intervention|Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
11998057|NCT00607607|Drug|MKC-1|capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
11998058|NCT00607594|Drug|saracatinib|Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.
11998059|NCT00607581|Drug|cyclophosphamide|cyclophosphamide: 500 mg orally on days 1, 8, 15
11998060|NCT00607581|Drug|lenalidomide|lenalidomide: 15 mg orally on days 1-21
11998061|NCT00607581|Drug|dexamethasone|dexamethasone: 40 mg orally on days on days 1, 8, 15, 22
11998062|NCT00607568|Drug|Atomoxetine|"atomoxetine 40mg per day or placebo
~For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II."
11998063|NCT00607555|Device|Insertion of specialized feeding tube for monitoring of EAdi|The specialized feeding tube will be inserted into the esophagus and positioned at the level of the crural diaphragm. EAdi will be measured with miniaturized coated stainless steel electrodes mounted on the feeding tube. The tube is connected to a monitor where EAdi will be recorded continuously throughout the entire study period
11998064|NCT00607542|Drug|baclofen|2.5 mg oral baclofen tablets given three times a day; dose gradually escalated as specified in the protocol
11998065|NCT00607529|Other|hand-held POC creatinine analyzer-blood test|"This study will require the collection of a finger-puncture capillary blood specimen in addition to one green stoppered heparin containing collection tube. This is taken pre-therapy. The capillary whole blood specimen will be used to perform a creatinine determination on the investigational hand-held creatinine analyzer using special test strips for the analysis."
11998066|NCT00607516|Procedure|Cemented primary bipolar hemiarthroplasty of the hip|Cemented primary bipolar hemiarthroplasty of the hip
11998067|NCT00607516|Procedure|Uncemented primary bipolar hemiarthroplasty of the hip|Uncemented primary bipolar hemiarthroplasty of the hip
11998068|NCT00607503|Drug|Terbutaline|"Each subject will be treated with terbutaline for 21-28 days following the initiation of treatment during the CRC admission.
~Subjects weighing between 25 and 45 kg will be treated with a nightly oral dose of 2.5 mg and subjects who weigh more than 45 kg will be treated with 3.75 mg.
~The standard 2.5 mg terbutaline tablets available in a pharmacy will be used in the study, with subjects taking either 1 or 1.5 tablets nightly."
11998069|NCT00607490|Behavioral|Cognitive-Behavioral Therapy|Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
11998070|NCT00607490|Behavioral|Supportive Psychotherapy|Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
11998071|NCT00607477|Drug|Minoxidil|2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
11998072|NCT00607477|Drug|Hydralazine|25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
11998073|NCT00607464|Device|Polyethylene occlusive skin wrap|Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment
11998074|NCT00607451|Drug|Neu-120|Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration.
11998075|NCT00607438|Drug|Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane)|125 mg/m2 Paclitaxel by 30-minute IV infusion weekly for 3 weeks.
11998076|NCT00607438|Drug|Sorafenib (Nexavar)|400 mg orally twice a day continuously (even during rest week) starting on Day 1.
11998077|NCT00607412|Behavioral|Integrated psychotherapy for PTSD and substance use|integrated, present focused psychotherapy for PTSD and substance use disorders tailored to women who have experienced intimate partner violence
11998709|NCT00602602|Other|immunohistochemistry staining method|
11998081|NCT00607373|Drug|mipomersen|200 mg mipomersen administered once a week for 26 weeks as a 1 mL subcutaneous injection. Subjects weighing less than 50 kg received a lower dose of 160 mg (0.8mL) mipomersen.
11998082|NCT00607373|Drug|Placebo|1 mL subcutaneous injection once a week for 26 weeks. Subjects weighing less than 50 kg received 0.8 mL subcutaneous injection.
11998083|NCT00607360|Behavioral|Therapeutic Workplace Intervention|Therapeutic workplace intervention is intended for individuals with drug addiction and chronic unemployment. Participants are invited to participate in work and receive salary for participation and productivity contingent upon drug abstinence.
11998084|NCT00607347|Other|Glucose|Oral Glucose Tolerance Test
11998085|NCT00607334|Behavioral|Word-learning|Exposure to five nonwords for three sessions of controlled interaction with the experimenter
11998086|NCT00607334|Behavioral|Word-learning|Exposure to five nonwords for three sessions of controlled interaction with the experimenter
11998087|NCT00607321|Device|Medtronic Bifurcation Stent System|Percutaneous Coronary Stenting
11998088|NCT00607308|Biological|PF-04360365|Single dose of 0.1 mg/kg IV on Day 1
11998089|NCT00607308|Biological|PF-04360365|Single dose of 0.5 mg/kg IV on Day 1
11998090|NCT00607308|Biological|PF-04360365|Single dose of 1 mg/kg IV on Day 1
11998091|NCT00607308|Biological|PF-04360365|Single dose of 5 mg/kg IV on Day 1
11998092|NCT00607308|Drug|Placebo|Single dose of placebo IV on Day 1
11998093|NCT00607308|Biological|PF-04360365|Single dose of 10 mg/kg IV on Day 1
11998094|NCT00607295|Drug|clino-san vaginal lubricant|Clino-san 2ml vaginal application 3 times per week for 12 weeks
11998095|NCT00607282|Drug|Udenafil|oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)
11998096|NCT00607269|Behavioral|Voucher-Based Reinforcement Therapy|"Participants were randomized into either the CM or control condition. Both conditions earned points for attendance and participation (max 364 points).
~Participants in the CM condition also earned points for targeted health-promoting behaviors and for drug/alcohol abstinence. CM points for targeted health-promoting behaviors were not limited. Points for abstaining from substance use were awarded based on a Level 1 (recent abstinence for amphetamine, methamphetamine, PCP, and cocaine metabolites, as well as blood alcohol <0.05) urine sample."
11998097|NCT00607256|Drug|[S,S]-reboxetine|S_S reboxetine dosed daily.
11998098|NCT00607243|Biological|smallpox vaccine CJ-50300|Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
11998099|NCT00607230|Biological|BCG|BCG vaccination at 0 and 4 weeks
11998100|NCT00607230|Biological|Saline|Saline vaccination at 0 and 4 weeks
11998101|NCT00607217|Biological|influenza vaccine|Intramuscular injection of one 0.5-mL dose of influenza vaccine
11998102|NCT00607217|Biological|placebo for influenza vaccine|Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
11998103|NCT00607217|Biological|influenza vaccine|Intramuscular injection of one 0.5-mL dose of influenza vaccine
11998104|NCT00607178|Biological|influenza vaccine|Intramuscular injection of one 0.5-mL dose of influenza vaccine
11998105|NCT00607178|Biological|placebo for influenza vaccine|Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
11998106|NCT00607152|Drug|Rasburicase|0.20mg/kg per day IV
11998107|NCT00607152|Drug|Allopurinol|100mg tablets
11998108|NCT00607126|Device|Lokomat|locomotor training using body weight support on a treadmill
11998109|NCT00607126|Procedure|resistive training|resistive training using theraband and/or weights
11998110|NCT00607113|Drug|Avastin|15 mg/kg By Vein Over 90 Minutes Every 21 Days
11998111|NCT00607113|Drug|RAD001|10 mg By Mouth Daily For 21 Days
11998112|NCT00607087|Drug|Insulin glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
11998113|NCT00607087|Drug|Insulin lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
11998114|NCT00607087|Drug|Insulin aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
11998115|NCT00607074|Drug|Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)|Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg)
11998116|NCT00607074|Drug|Anti-Giardia treatment only (secnidazole or albendazole)|Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole
11998117|NCT00607074|Drug|Control group (placebo)|Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo
11998118|NCT00607061|Procedure|Blood sample collection|Blood of the umbilical cord will be collected after delivery. A mother blood sample will be also collected in the few hours preceding delivery to determine glutathione and cysteine concentrations.
11998119|NCT00607048|Drug|Paclitaxel + Carboplatin + CP-870,893|Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)
11998120|NCT00607048|Drug|Paclitaxel + Carboplatin + CP-870,893|Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)
11998121|NCT00607035|Drug|Olmesartan medoxomil ＋Azelnidipine|The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day for 6 months.
11998122|NCT00607035|Drug|Olmesartan medoxomil + Hydrochlorothiazide|The ARB plus Diuretics combination therapy group is administered olmesartan medoxomil 20mg/day and hydrochlorothiazide 12.5mg/day for 6 months.
11998123|NCT00607022|Device|dental implant|Dental implant stability measured with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement.
11998124|NCT00607009|Behavioral|ALIVE|ALIVE email-based behavioral program based on the participants selected intervention - physical activity, fats/sugars or fruits/vegetabls
11998125|NCT00606996|Behavioral|Group interpersonal psychotherapy (IPT-G)|
11998126|NCT00606996|Behavioral|Psychoeducation on co-occurring disorders (PSYCHOED)|
11998127|NCT00606983|Drug|Tamsulosin|oral administration of Tamsulosin
11998128|NCT00606970|Dietary Supplement|Seigen Alpha EV|Orally administered Seigen Alpha EV, 1 packet (6 grams)3 times daily, for maximum of 3 months. Each packet is clearly marked for breakfast, lunch, or supper. The contents are to be dissolved in water or liquid and taken orally with meal. Subjects will be required to return any unused packets to study doctor at end of each month.
11998129|NCT00606970|Dietary Supplement|Placebo Comparator|Identically packaged placebo packets (each 6 grams) taken 3x daily with meals for 3 months maximum.
11998130|NCT00606957|Dietary Supplement|Vitamin D3 (cholecalciferol)|Vitamin D will be taken orally, 10,000 IU (0.25 mg) three times per week.
11998131|NCT00606944|Behavioral|fast-track rehabilitation|fast-track rehabilitation with early ambulation and diet after elective colorectal resection
11998132|NCT00606931|Device|Stereo Navigator Accessory to PEM Flex PET Scanner|For patients with suspicious breast abnormalities seen on high resolution PET image, the patients will be biopsied using commercial vacuum biopsy devices (pre-validated to work with Stereo Navigator) using Naviscan's Stereo Navigator (interventional device) for PET image guidance.
11998133|NCT00606905|Biological|Gamimune N or Gamunex 10%|500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
11998134|NCT00606905|Other|normal saline|equivalent volume of normal saline
11998135|NCT00606892|Drug|Varenicline|Varenicline (1 mg per day) given for 4 days prior to laboratory session
11998136|NCT00606892|Drug|Placebo|Sugar Pill
11998137|NCT00606892|Drug|IV Nic|IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.
11998138|NCT00606879|Drug|SGX523 Capsules|This is a dose escalation study
11998139|NCT00606866|Drug|placebo|Placebo for four weeks
11998140|NCT00606866|Drug|Sorafenib|Sorafenib 200 mg twice daily
11998141|NCT00606866|Drug|Sorafenib|Sorafenib, 400 mg twice daily
11998142|NCT00606853|Behavioral|Contingency Management|Rewards valued $1-$100 for abstinence or treatment attendance
11998143|NCT00606840|Behavioral|large changes in eating and activity|Behavioral self-regulation interventions to prevent weight gain in young adults.
11998144|NCT00606840|Behavioral|small changes in eating and activity|Behavioral self-regulation interventions to prevent weight gain in young adults.
11998145|NCT00606827|Drug|Sodium Bicarbonate|Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure
11998146|NCT00606827|Drug|Isotonic Saline|Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure
11998147|NCT00606814|Drug|IPI-504, docetaxel|"IPI-504 administered IV at a dose of 300mg/m2
~Docetaxel at a fixed dose of 75 mg/m2 for every 3 weeks dose administration or 36 mg/m2 for weekly administration"
11998148|NCT00606801|Drug|Galantamine|Galantamine 8 mg/day
11998149|NCT00606801|Drug|placebo|sugar pill
11998150|NCT00606788|Device|SmartCare/PS (Automated Weaning)|Patients received computer-driven protocolized weaning
11998151|NCT00606788|Procedure|Conventional weaning|Patients received physician-directed non-protocolized weaning
11998152|NCT00606775|Drug|Carvedilol|2.5-5mg/day
11998153|NCT00606762|Procedure|Laparoscopic cholecystectomy|Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure
11998154|NCT00606749|Drug|KC706|300 mg once daily (QD) for 12 weeks.
11998155|NCT00606723|Biological|Hematopoietic stem cells from bone marrow or peripheral blood|> = 2 x 10*8 nucleated cells (WBC)/kg body weight of the recipient or rather > = 4 x 10*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion.
11998156|NCT00606710|Device|Cognis 100-D, Teligen DR, VR 100 HE|ICD or CRT - Therapy
11998157|NCT00606697|Drug|GR205171|10 milligrams (mg)
11998158|NCT00606697|Drug|GW597599|15 mg
11998159|NCT00606684|Drug|GW642444 6.25|GW642444 6.25
11998160|NCT00606684|Drug|GW642444 3mcg|once daily
11998161|NCT00606684|Drug|GW642444 12.5mcg|GW642444 12.5mcg
11998162|NCT00606684|Drug|GW642444 25mcg|GW642444 25mcg
11998163|NCT00606684|Drug|GW642444 50mcg|GW642444 50mcg
11998164|NCT00606684|Other|placebo|placebo
11998165|NCT00606658|Procedure|Shirodhara Oil Treatment|Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.
11998166|NCT00606645|Biological|XmAb2513|Intravenous infusion of XmAb2513 administered at a dose of 0.3, 1.0, 3.0, 6.0, 9.0, or 12 mg/kg in sequential dose cohorts.
11998167|NCT00606632|Drug|124-Iodine-cG250 (124I-cG250)|i.v. and PET/CT scan 4+/-2 days after administration
11998168|NCT00606632|Procedure|CT|contrast enhanced CT scan
11998169|NCT00606619|Other|Conventional feeding|Procedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day.
11998170|NCT00606619|Other|Early oral feeding|Procedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day.
11998171|NCT00606606|Other|Clinical Decision Support|
11998172|NCT00606593|Drug|ACT-078573 oral capsules at 25 and 100 mg and matching placebo|5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998173|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998174|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998175|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998176|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998710|NCT00602602|Other|laboratory biomarker analysis|
11998177|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998178|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998179|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998180|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998181|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
11998182|NCT00606580|Drug|WR 279,396 topical cream|WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
11998183|NCT00606580|Drug|Paromomycin Alone topical cream|The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
11998184|NCT00606580|Drug|Vehicle placebo cream|Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
11998185|NCT00606567|Other|Methods for monitoring patients with ICD's|Intervention comparing 2 different methods of monitoring patients with ICDs; at home monitoring vs. quarterly monitoring in the clinic.
11998186|NCT00606554|Device|Computer-assisted weaning program|Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
11998187|NCT00606554|Behavioral|Standard of Care weaning|Evidence-based standard of care weaning process.
11998188|NCT00606541|Drug|Quetiapine XR|This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).
11998189|NCT00606541|Drug|Placebo|Placebo
11998190|NCT00606528|Other|No intervention|None. This is an observational study.
11998191|NCT00606515|Drug|Liposomal paclitaxel|Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
11998192|NCT00606515|Drug|Paclitaxel|Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
11998193|NCT00606502|Drug|Pralatrexate|"Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).
~Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications.
~Protocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications.
~Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met."
11998194|NCT00606502|Drug|Erlotinib|"150 mg orally in tablet form
~Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met."
11998195|NCT00606502|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment."
11998196|NCT00606502|Dietary Supplement|Folic Acid|"1-1.25 mg orally
~Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment."
11998197|NCT00606489|Drug|Caldolor|800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours
11998198|NCT00606489|Drug|Placebo|Placebo
11998199|NCT00606476|Drug|Bapineuzumab (AAB-001)|IV q13w
11998200|NCT00606463|Device|Cardiac Ablation (Gen2 Cardiac Ablation System)|Ablation of isthmus-dependent atrial flutter
11998201|NCT00606450|Drug|CC-10004|20 mg CC-10004 taken 1 time per day for 12 weeks
11998202|NCT00606450|Drug|CC-10004|20 mg of CC-10004 taken 2 times per day for 12 weeks
11998203|NCT00606450|Drug|Placebo|matching placebo taken either 1 or 2 times per day for 12 weeks
11998204|NCT00606437|Procedure|Total Body Irradiation with Fludarabine in UCB Transplants|Administration of the preparative regimen, infusion of the stem cell graft, inpatient care during the immediate post-transplant period and outpatient follow-up for the first 3 months after transplant and at 6, 12, 24 and 36 months. Patients will have human leukocyte antigen (HLA) serologic typing and DNA typing. Bags of UCB are thawed, and diluted by 1:1 volume using a 5% albumin/dextran solution. The thawed and diluted umbilical cord blood unit (UCBU) is next weighed and centrifuged. Specimens are obtained for cell count and viability, culture, clonogenic assays, and phenotype. The UCB is infused at a rate of 1-3 ml/min. Furosemide (0.5-1.0 mg/kg/dose) may be given if volume overload or decreased urine output occurs. Each UCB infusion shall be tested for sterility, CFU content, number of CD34+ cells, cell count and viability.
11998205|NCT00606424|Drug|20 mCi dose for a 50 kg individual of [F-18]HX4|All subjects, normal volunteers and cancer subjects will receive HX4 administered through a previously placed suitably sized angiocatheter or a butterfly needle. Prior to injection, qualified site personnel will assay the dose in the dose calibrator and document the activity of the dose and time of assay. After injection, the line will be flushed with saline (approximately 10 mL).
11998206|NCT00606411|Drug|Topiramate or Placebo|25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
11998207|NCT00606398|Procedure|surgical resection for patients with both intra- and extra-hepatic metastases|Simultaneous resection with R0 intent of intra-abdominal metastases from CRC. For patients with extra-abdominal disease, sequential resection will be permitted
11998208|NCT00606385|Procedure|Liver resection|Laparoscopic or Open hepatectomy
11998209|NCT00606372|Procedure|OPCAB - the off-pump coronary artery bypass|surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart
11998210|NCT00606359|Biological|Inactivated, split-virion influenza virus|0.1 mL, Intradermal. 2 vaccinations 12 months apart
11998211|NCT00606359|Biological|Inactivated, split-virion influenza virus|0.5 mL, Intramuscular. 2 vaccinations, 12 months apart
11998212|NCT00606346|Biological|Anti TNF therapy including infliximab|Treatments will be prescribed according to investigator judgement.
11998213|NCT00606346|Drug|No Biologics|Treatments will be prescribed according to investigator judgement.
11998214|NCT00606333|Device|NEVO™ Sirolimus-eluting Coronary Stent System|Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
11998215|NCT00606333|Device|Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)|Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
11998216|NCT00606320|Drug|Aripiprazole|oral, 24mg(4 tablets)/day
11998217|NCT00606307|Drug|ITF2357|50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
11998218|NCT00606294|Radiation|fluorine-18-labeled fluoro-misonidazole (18F-FMISO)|
11998219|NCT00606294|Device|18F-FMISO PET scan|
11998220|NCT00606294|Device|MRI|
11998221|NCT00606294|Device|FDG PET/CT scan|
11998222|NCT00606281|Drug|Aripiprazole|oral, 24mg/day
11998223|NCT00606281|Drug|placebo|oral, 0mg(4tablets)/day
11998224|NCT00606268|Drug|Micafungin|IV
11998225|NCT00606242|Drug|Fluticasone|Inhaled Fluticasone, either 100 or 1000 mcg per day
11998226|NCT00606229|Drug|Aripiprazole|oral, 24mg/day
11998227|NCT00606216|Procedure|MRI and cognitive evaluation|Patients will undergo a brain MRI study and a brief neuropsychological evaluation, at the time of enrollment for controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients. A follow-up MRI and cognitive evaluation will be performed approximately 12 months after the transplant for patients.
11998228|NCT00606216|Procedure|MRI and cognitive evaluation|Pt will undergo a Magnetic Resonance Imaging (MRI) study of the brain and a brief neuropsychological evaluation, at the time of enrollment for healthy controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients (Baseline/Time 1).
11998229|NCT00606216|Procedure|brain MRI study and a brief neuropsychological evaluation|A brain MRI study and a brief neuropsychological evaluation will be performed at baseline (Time 1). A follow-up MRI and cognitive evaluation will be performed and about 12 months after the baseline for healthy controls
11998230|NCT00606203|Drug|milnacipran|taking milnacipran(50) 1#bid after stoke to prevent the occurence of depression
11998231|NCT00606203|Drug|placebo|placebo
11998232|NCT00606190|Procedure|Retrograde brain perfusion|observational
11998233|NCT00606190|Procedure|Antegrade brain perfusion|observational
11998234|NCT00606177|Drug|Aripiprazole|oral, 24mg(4 tablets)/day
11998235|NCT00606177|Drug|placebo|oral, 0mg(4tablets)/day
11998236|NCT00606164|Drug|Bryostatin for Injection|A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1
11998237|NCT00606164|Drug|Placebo|A single one-hour intravenous infusion of placebo on Day 1
11998238|NCT00606138|Drug|ranibizumab|One 0.5 mg intravitreal injection
11998239|NCT00606138|Procedure|Laser photocoagulation|panretinal photocoagulation (up to 500 300-500 um laser spots)
11998240|NCT00606125|Drug|Nexavar (Sorafenib, BAY43-9006)|The purpose of this study is to: 1)evaluate how your body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2) measure your blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3) to determine the safety of sorafenib.
11998241|NCT00606112|Drug|Trodusquemine (MSI-1436)|A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
11998242|NCT00606099|Drug|telbivudine|To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
11998243|NCT00606099|Drug|adefovir dipivoxil|Active Comparator
11998244|NCT00606086|Drug|GI-5005|40YU, subcutaneous
11998245|NCT00606086|Drug|Pegylated Interferon and Ribavirin|Pegylated interefron is an injection and ribavirin is an oral tablet
11998246|NCT00606073|Other|Universal IVF Medium + ISM1 Medium|Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection. Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance. After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only. The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.
11998247|NCT00606060|Drug|Kogenate (BAY14-2222)|100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients.
11998248|NCT00606047|Radiation|Magnetic resonance imaging (MRI)|Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints.
11998249|NCT00606034|Drug|U-500 Insulin delivered by Omnipod (disposable insulin pump)|U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs
11998250|NCT00606021|Drug|pemetrexed|500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
11998251|NCT00606021|Drug|Best Supportive Care|Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
11998252|NCT00606008|Drug|Sunitinib Malate|Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.
11998253|NCT00605995|Drug|Simvastatin|20 mg taken orally once daily for the first 4 weeks. Dosage will be increased to 40 mg/day at the end of week 4.
11998254|NCT00605982|Procedure|MRI|The patient will then undergo a breast MRI as part of their preoperative work-up of DCIS. Biopsy of any suspicious areas by needle biopsy or at the time of surgery. If appropriate, repeat MRI after biopsy or surgery. Follow-up for 10 years (you will be contacted once a year to see how you are doing).
11998255|NCT00605969|Procedure|Motion analysis|Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.
11998256|NCT00605969|Diagnostic Test|Computed Tomography|Participants will undergo computed tomography (CT) scan of their hip.
11998257|NCT00605956|Drug|NatrOVA Creme Rinse - 1%|NatrOVA Creme Rinse - 1% spinosad
11998258|NCT00605956|Drug|NatrOVA Creme Rinse Vehicle Only|NatrOVA Creme Rinse Vehicle - no spinosad
11998259|NCT00605956|Drug|Blank Patch|Blank Patch
11998260|NCT00605930|Dietary Supplement|Pyruvate, creatine, niacinamide|A bar of 2 gm of pyruvate and 1 gm of creatine, and a pill of 1 gm of niacinamide once a day for 24 weeks.
11998261|NCT00605930|Dietary Supplement|Placebo|25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.
11998262|NCT00605917|Drug|Sertraline hydrochloride|"J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.
~Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms.
~Duration: According to the protocol of A0501092, the duration of the investigation for findings regarding safety and efficacy of a panic disorder patient is from the first drug administration to the 16 weeks after the first administration."
11998263|NCT00605904|Drug|Acamprosate|orally administered tablet, 333mg, three times daily for a minimum of 2 weeks (14 days)
11998264|NCT00605904|Drug|Yohimbine|Intravenous infusion of yohimbine (0.4 mg/kg) administered once over 10 minutes
11998265|NCT00605904|Drug|mCPP|Intravenous infusion of mCPP (0.05 mg/kg) over 10 minutes, two times, for a total of 0.1 mg/kg
11998266|NCT00605904|Drug|Saline|"Intravenous infusion of 0.9% sodium chloride solution over 10 minutes, three times during the study (2 times for the Saline Infusion milestone, and one time immediately following the Yohimbine Infusion milestone)"
11998267|NCT00605891|Drug|carmoterol (CHF 4226)|"carmoterol pMDI 2.0 μg once a day, in the morning
~(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)"
11998268|NCT00605891|Drug|carmoterol (CHF 4226)|"carmoterol pMDI 1.0 μg once a day, in the morning
~(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))"
11998269|NCT00605891|Drug|carmoterol (CHF 4226)|"carmoterol pMDI 4.0 μg once a day, in the morning
~(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)"
11998270|NCT00605891|Drug|salmeterol|Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
11998271|NCT00605891|Drug|placebo|Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
11998272|NCT00605865|Drug|Sertraline hydrochloride|"J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.
~Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms.
~Duration: According to the protocol of A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration."
11998273|NCT00605852|Drug|GSK835726|GSK835726 will be available in single dose and repeat dose formulations.
11998274|NCT00605852|Drug|Placebo|Placebo will be given to subjects.
11998275|NCT00605839|Device|GlucoPak|We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
11998276|NCT00605839|Device|Cell Phone|We will provide cell phones and access to the clinic to facilitate communications
11998277|NCT00605839|Other|Usual Care|This intervention was usual care, without either device.
11998278|NCT00605826|Device|NASHA/Dx (Solesta) Gel|Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
11998279|NCT00605826|Device|Sham Injection|Sham injection at the start of the blinded phase.
11998280|NCT00605813|Drug|Sertraline hydrochloride|"J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.
~Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms.
~Duration: According to the protocol of A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration."
11998281|NCT00605800|Other|blood drawn|Baseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes).
11998282|NCT00605800|Other|blood drawn|At the time of preoperative testing, patients will have two extra test tubes (5cc blue top) of blood drawn for determination of pre-operative base line levels of bone marrow derived liver stem cells in peripheral blood. Intraoperatively, blood will be drawn after liver resection (two tubes of 5cc blue top). Two extra tube of blood will be drawn at the same time of routine postoperative blood drawing to determine levels of bone marrow derived liver stem cells in peripheral blood on post-operative days #1, and #3.
11998283|NCT00605787|Drug|Tetradecylthioacetic acid (TTA)|1000mg capsules once daily for 28 days
11998284|NCT00605774|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infused over two hours during experimental period on Day 2
11998285|NCT00605774|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infusion during hyperinsulinemic euglycemic clamp on day 2
11998286|NCT00605761|Drug|SB656933|50 mg treatment
11998287|NCT00605761|Drug|SB656933|150 mg treatment
11998288|NCT00605748|Procedure|Segmental PV-Isolation of the arrhythmogenic vein(s)|isolation of pulmonary veins for curing atrial fibrillation
11998289|NCT00605748|Procedure|Segmental PV-Isolation of all veins|isolation of pulmonary veins for curing atrial fibrillation
11998290|NCT00605735|Drug|BMS-582949|Tablets, Oral, 300 mg, once daily, 12 weeks
11998291|NCT00605735|Drug|Placebo|Tablets, Oral, placebo, once daily, 12 weeks
11998292|NCT00605722|Drug|bevacizumab (Avastin)|5 mg/kg iv on day 1 of each 2 week cycle.
11998293|NCT00605722|Drug|erlotinib (Tarceva)|150 mg orally (po) daily.
11998294|NCT00605709|Drug|API 31510 Topical Cream|Topical treatments to lesion twice daily of randomized treatments.
11998295|NCT00605696|Drug|Insulin|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.
11998296|NCT00605683|Drug|Safinamide (as add-on therapy)|Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
11998297|NCT00605683|Drug|Safinamide (as add-on therapy)|Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
11998298|NCT00605683|Drug|Safinamide (as add-on therapy)|Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
11998299|NCT00605670|Behavioral|questionnaires|patients will fill out two questionnaires post surgery
11998300|NCT00605670|Behavioral|questionnaires|Patient will fill out questionnaire before and 3 to 6 months after treatment.
11998301|NCT00605657|Drug|Valproic Acid|Oral administration of valproic acid
11998302|NCT00605657|Procedure|CT Scan|CT scans were done before and after treating the patient with valproic acid
11998303|NCT00605657|Procedure|Blood Sample|Blood samples were collected before and after the intervention to monitor blood counts and biomarkers of ALPS
11998304|NCT00605644|Drug|MOA-728|Oral Capsules
11998305|NCT00605644|Drug|Placebo|Placebo
11998306|NCT00605631|Device|Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System|No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.
11998307|NCT00605618|Drug|BMS-777607|Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation
11998308|NCT00605605|Drug|Dextromethorphan|120 mg/day, single once daily dose taken after breakfast by oral route
11998309|NCT00605592|Procedure|Pancreatic Islets of Langerhans Cell Transplant|Transplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
11998310|NCT00605566|Drug|Sorafenib|"During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
11998311|NCT00605566|Drug|Cyclophosphamide|"During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
11998312|NCT00605553|Drug|Placebo|"Placebo oral capsules
~Placebo for 7 days"
11998313|NCT00605553|Drug|Tozadenant|20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
11998314|NCT00605514|Drug|VRC-EBODNA023-00-VP|
11998315|NCT00605514|Drug|VRC-MARDNA025-00-VP|
11998316|NCT00605488|Procedure|novel PET tracer FACBC|Two IV catheters (heplock) will be placed in your forearms for injection of the dye-like material (FACBC) and blood sampling. An IV blood sample and a urine sample will be taken for testing. These samples will be used to measure the dye, FACBC, in blood and urine. You will be placed in the PET machine, where FACBC will be injected slowly over 30 seconds. Pictures of one region of your body will be taken for up to 60 minutes. Depending on your condition, your actual picture time may be shorter. You will come out of the scanner to stretch, walk around or sit in a chair. An optional urine sample and an IV blood sample will also be taken at this time. Again, these samples will be used to measure the dye, FACBC, in blood and urine. This will be followed by a picture of your body from the neck to the upper thighs. This picture will take about 30 minutes.
11998317|NCT00605475|Drug|Canakinumab|Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.
11998318|NCT00605475|Drug|Placebo|Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.
11998319|NCT00605475|Drug|Metformin|Participants continued on their stable daily dose of metformin throughout the study
11998320|NCT00605449|Drug|GSK376501|
11998321|NCT00605436|Behavioral|Restorative yoga therapy|3-hour workshop at study initiation. Then twice-weekly group yoga classes for 5 weeks, then once-weekly group yoga classes for 5 weeks. Home yoga practice for 90 minutes/week throughout the 10 week trial.
11998322|NCT00605423|Drug|Fluocinolone Acetonide/Medidur|0.2 ug/day implant
11998323|NCT00605423|Drug|Fluocinolone Acetonide/Medidur|0.5 ug/day implant
11998324|NCT00605410|Drug|ipratropium bromide|2 puffs (40 micrograms) 2 puffs (0micrograms)
11998325|NCT00605410|Drug|placebo|Matched placebo
11998373|NCT00605072|Drug|metoprolol, long-acting|If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg
11998326|NCT00605397|Radiation|PET Imaging With Cu-64 Labeled Trastuzumab|The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease.
11998327|NCT00605397|Radiation|PET Imaging With Cu-64 Labeled Trastuzumab|The remaining 20 patients will undergo one PET study.
11998328|NCT00605384|Drug|Entecavir + Tenofovir|Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
11998329|NCT00605384|Drug|Adefovir + continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
11998330|NCT00605371|Drug|Lamotrigine tablet|Lamotrigine extended release single dose tablet will be available with dosing strengths of 200 milligrams and 50 milligrams intended to be administered orally in fasted state. It will be a round standard convex shape tablet.
11998331|NCT00605371|Drug|Lamotrigine caplet|Lamotrigine extended release single dose caplet will be available with dosing strength of 200 milligrams and 50 milligrams intended to be administered orally in fasted and fed state.
11998332|NCT00605358|Behavioral|Open Door intervention|"Open Door intervention subjects will:
~receive an evaluation
~receive a referral to a local mental health provider
~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
11998333|NCT00605345|Drug|Darbepoetin alfa|As prescribed
11998334|NCT00605345|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms sc 4-weekly (starting dose)
11998335|NCT00605332|Device|inferior vena cava filter|Crux Biomedical IVC Filter
11998336|NCT00605319|Drug|Toviaz (Fesoterodine)|4mg to 8mg by mouth once daily
11998337|NCT00605306|Drug|indacaterol maleate / mometasone furoate|Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.
11998338|NCT00605306|Drug|placebo to indacaterol maleate/mometasone furoate|Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
11998339|NCT00605293|Drug|methoxy polyethylene glycol-epoetin beta|120, 200 or 360 micrograms iv/month (starting dose)
11998340|NCT00605293|Drug|Epoetin alfa|As prescribed
11998341|NCT00605280|Drug|Standard of Care|Clinicians decision to use optional laser therapy.
11998342|NCT00605280|Drug|Macugen|Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
11998343|NCT00605267|Drug|Tamoxifen|20 mg once daily oral dose
11998344|NCT00605267|Drug|Anastrazole (Arimidex)|1 mg once daily oral dose
11998345|NCT00605267|Drug|Goserelin acetate (Zoladex)|3.6mg/month depot injection
11998346|NCT00605241|Drug|GSK598809|Drug
11998347|NCT00605228|Drug|MOVIPREP|2L Drug
11998348|NCT00605228|Drug|COLOPEG|4L Drug
11998349|NCT00605215|Drug|laquinimod|0.6 mg oral once daily for 24 months
11998350|NCT00605215|Drug|placebo|oral placebo once daily for 24 months
11998351|NCT00605215|Drug|Interferon β-1a (Avonex®)|Interferon β-1a (Avonex®) 30 mcg IM once weekly for 24 months
11998352|NCT00605202|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25 mg a day for 14 days.
11998353|NCT00605202|Dietary Supplement|Licorice|Licorice candy 32 grams a day for 14 days.
11998354|NCT00605189|Device|Powered Suction Pump (VAC Freedom)|continuous foam based negative pressure wound therapy
11998355|NCT00605189|Device|Powered Suction Pump|continuous gauze based negative pressure wound therapy
11998356|NCT00605189|Device|MWT|moist wound therapy
11998357|NCT00605176|Drug|imiquimod cream|cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
11998358|NCT00605176|Drug|imiquimod cream|cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
11998359|NCT00605176|Drug|Placebo|cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
11998360|NCT00605150|Radiation|TheraSphere-Yttrium 90 microsphere|TheraSphere is delivered to the liver via a catheter placed into the femoral artery and guided by fluoroscopy to the hepatic artery. Once the catheter is properly positioned, the physician infuses TheraSphere, which localizes preferentially in the tumor.
11998361|NCT00605137|Drug|insulin detemir|
11998362|NCT00605137|Drug|insulin NPH|
11998363|NCT00605124|Other|Knee muscle exercises|Home exercises three times a week, control every three months
11998364|NCT00605111|Drug|biphasic insulin aspart|
11998365|NCT00605098|Drug|Lopinavir / ritonavir|Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation and maintained for at least 6 weeks after delivery.
11998366|NCT00605098|Drug|Lopinavir/ritonavir|Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation, increase the lopinavir/r dosage (200/50 mg, 3 tablets every 12 hours) in the third trimester (from 25 weeks on), and return to standard dose(200/50 mg, 2 tablets every 12 hours)for at least 6 weeks after delivery.
11998367|NCT00605085|Biological|Japanese Encephalitis purified inactivated vaccine (IC51)|IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
11998368|NCT00605085|Biological|Placebo|Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28
11998369|NCT00605072|Drug|candesartan|orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
11998370|NCT00605072|Drug|lisinopril|orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
11998371|NCT00605072|Drug|hydrochlorothiazide|orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
11998372|NCT00605072|Drug|nifedipine, long acting|If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
11998705|NCT00602602|Biological|bevacizumab|
11998374|NCT00605059|Drug|[123I]AV94|Evaluation of [123I] AV94 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
11998375|NCT00605046|Drug|SPECT scan|AV151-01: Evaluation of [123I] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
11998376|NCT00605033|Drug|Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484|Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days
11998377|NCT00605033|Drug|Subutex, Buprenorphine Hydrochloride, SCH 28444|Subutex sublingual tablet 4-24 mg, daily for 28 days
11998378|NCT00605020|Drug|insulin detemir|
11998379|NCT00605020|Drug|insulin aspart|
11998380|NCT00605020|Device|biphasic insulin aspart|
11998381|NCT00604981|Behavioral|Multisystemic Therapy (MST)|MST is an intensive, family centered, community based treatment originally designed for use with adolescents presenting with serious mental health problems. In this study, MST interventions are aimed at increasing adolescent and family adherence to dietary and exercise recommendations and targeting barriers within the family system, and the broader community systems within which the family is embedded (peers, schools, health care). Decreasing caloric consumption consistent with recommended intake targets, increasing daily exercise and decreasing sedentary activity, are treatment focuses depending on whether the adolescent has difficulty with this aspect of weight management or not.
11998382|NCT00604981|Behavioral|Shapedown|Shapedown, is a clinic-based, adolescent weight loss intervention. Shapedown utilizes psycho educational, behavior, and family therapy techniques in a 10-week group intervention. In order to match MST's length of intervention (6 months), three follow-up sessions are added at monthly intervals.
11998383|NCT00604968|Drug|Caelyx (pegylated liposomal doxorubicin; SCH 200746)|Caelyx will be administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
11998384|NCT00604955|Drug|Paromomycin sulfate|Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
11998385|NCT00604942|Procedure|Heller's Myotomy|Long vs Short Heller's Myotomy for Achalasia
11998386|NCT00604942|Procedure|Nissen Fundoplication|Partial vs Full Fundoplication for GORD
11998387|NCT00604942|Drug|domperidone or esomeprazole (Conservative management)|Conservative management for dysphagia not referred for surgery. Conservative management: balloon dilatation or drugs such as domperidone 10 mg or esomeprazole 40 mg
11998388|NCT00604942|Drug|Esomeprazole 40 mg|Esomeprazole vs no esomeprazole for GORD not referred for surgery
11998389|NCT00604929|Dietary Supplement|carbohydrate and protein|The intake of carbohydrate and protein during endurance type exercise
11998390|NCT00604916|Other|standardized oral care protocol - electronic toothbrush|a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.
11998391|NCT00604916|Other|mimic protocol|a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.
11998392|NCT00604903|Device|Implant of Pressure sensor.|Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
11998393|NCT00604890|Drug|API 31510 3% Topical Cream|Topical treatment 3% active cream applied to the lesion
11998394|NCT00604890|Drug|API 31510 1.5% Topical Cream|Topical treatment 1.5% active cream applied to the lesion
11998395|NCT00604890|Other|Placebo|Topical treatment placebo applied to the lesion
11998396|NCT00604877|Behavioral|Treadmill Exercise|3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
11998397|NCT00604877|Behavioral|Stretching/ROM|3 times per week for 6 months, passive and active stretching and range of motion (ROM) exercises for the upper and lower extremities
11998398|NCT00604864|Drug|anti TNFa monoclonal antibody - Infliximab|Chimeric A2 (infliximab, RemicadeTM) IgG ; 100 mg infliximab IgG, Infliximab was freshly prepared immediately before each administration. Infliximab or placebo was administered as a slow infusion of 250mL on weeks 0, 2 and 6. Women were closely observed during, and for 1 hour after, the infusion in the event of any serious adverse reactions.
11998399|NCT00604864|Drug|placebo|Placebo
11998400|NCT00604838|Device|AL-SENSE Diagnostic Absorbent Panty liner|worn for 12 hours
11998401|NCT00604838|Device|AL-SENSE Diagnostic Absorbent Panty liner|Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours
11998402|NCT00604825|Drug|Other: Placebo|
11998403|NCT00604825|Drug|GSK232802|
11998404|NCT00604825|Drug|PREMARIN|
11998405|NCT00604812|Drug|rizatriptan benzoate (5 mg)|A single dose of rizatriptan 5 mg administered on Day 1.
11998406|NCT00604812|Drug|rizatriptan benzoate (10 mg)|A single dose of rizatriptan 10 mg administered on Day 1.
11998407|NCT00604812|Drug|Rizatriptan 5 mg Placebo|A single dose of rizatriptan 5 mg placebo administered on Day 1.
11998408|NCT00604812|Drug|Rizatriptan 10 mg Placebo|A single dose of rizatriptan 10 mg placebo administered on Day 1.
11998409|NCT00604799|Device|Talent Thoracic Stent Graft|TEVAR
11998410|NCT00604786|Drug|omalizumab|Dosing is based on IgE level and weight given every 2 or 4 weeks
11998411|NCT00604786|Drug|placebo|Dosing is based on IgE level and weight given every 2 or 4 weeks
11998412|NCT00604760|Drug|MEM 3454|Capsule 5 mg once a day
11998413|NCT00604760|Drug|MEM 3454|Capsule 15 mg once a day
11998414|NCT00604760|Drug|MEM 3454|Capsule 50 mg once a day
11998415|NCT00604760|Drug|Placebo for MEM 3454|Capsule once a day
11998416|NCT00604747|Other|Structure practice|there were 2 groups which received random practice and constant practice during acquisition phase
11998417|NCT00604734|Device|ReCap Total Hip Resurfacing System|This is a hip resurfacing system.
11998418|NCT00604721|Drug|selumetinib|Given orally
11998419|NCT00604721|Other|pharmacological study|
11998420|NCT00604708|Biological|IC51|IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
11998421|NCT00604708|Biological|JE-VAX|JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28
11998422|NCT00604695|Drug|Tenecteplase|Intracoronary injection of IV tenecteplase.
11998423|NCT00604695|Drug|Sterile Saline|Intracoronary injection of IV sterile saline
11998706|NCT00602602|Drug|fluorouracil|
11998424|NCT00604682|Drug|CC10004|2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted
11998425|NCT00604656|Drug|insulin aspart|
11998426|NCT00604643|Device|TALENT Aortic Cuff Abdominal Stent Graft|Endovascular Aneurysm Repair
11998427|NCT00604630|Drug|recombinant human erythropoietin alfa|40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
11998428|NCT00604630|Drug|0.9% NaCl|50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
11998429|NCT00604617|Procedure|Interferon-Gamma Release Assay|IGRAs
11998430|NCT00604617|Drug|RT-23|TST - tuberculin skin test
11998431|NCT00604604|Behavioral|Peer support|Mothers allocated to the peer support group had access to all of the standard community postpartum services in addition to having received telephone-based support from a peer volunteer (a mother who has previously experienced, and recovered from, postpartum depression and has participated in a 4-hour training session). Telephone contact with a new mother was initiated within 48 to 72 hours of trial enrolment and then as frequently as the dyad deemed necessary; a minimum of four contacts were required.
11998432|NCT00604591|Drug|Tolcapone|200 mg by mouth three times a day
11998433|NCT00604591|Drug|Placebo|200 mg by mouth three times a day
11998434|NCT00604578|Drug|Pioglitazone Hydrochloride|
11998435|NCT00604565|Drug|soluble ferric pyrophosphate (SFP)|"Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).
~Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0)"
11998436|NCT00604565|Other|placebo|Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
11998437|NCT00604552|Device|AneuRx Stent Graft|Abdominal Aortic Aneurysm Repair
11998438|NCT00604539|Drug|Chondroitin sulphate (Condrosan)|800 mg (two capsules of 400 mg each) taken once a day for one year
11998439|NCT00604539|Drug|Placebo|Two placebo capsules taken once a day for six months followed by an additional six month treatment of 800 mg (two capsules of 400 mg of Chondroitin sulphate each) taken once a day
11998440|NCT00604526|Radiation|High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds|"Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL
~*After 1 year, will follow up with doctor about every 6 months."
11998441|NCT00604513|Other|Ready. Set. ACTION! Protocol|"The intervention included three components: theater sessions; booster sessions; and family outreach. After-school theater sessions were conducted in the fall in the intervention schools. Sessions included: a check-in about changes made over the past week; healthy snacks; a movement component that involved fun and easy activities; and creating/education. Children at intervention schools participated in weekly after-school booster sessions in the winter to further address the behavioral messages addressed during the intervention. Throughout the program, weekly Fun & Fitness packs were sent home to families that included a healthy food with a simple recipe using that food or fitness incentives for the family. There were also two family events: a theater performance, and a reception."
11998442|NCT00604513|Other|Control|The control condition also participated in a theater-based intervention that addressed a health topic unrelated to weight, hand-washing and overall personal hygiene.
11998443|NCT00604500|Drug|SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.
11998444|NCT00604487|Device|ARD (Atad Ripener Device)|Atad double balloon ripener device
11998445|NCT00604487|Device|AID (Atad double balloon Instillation Device)|Double balloon instillation device and continuous extra-amniotic instillation of NS 50 Ml/hour
11998446|NCT00604487|Device|folly catheter|folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour
11998447|NCT00604474|Device|HiResolution Bionic Ear System (Cochlear Implant)|Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)
11998448|NCT00604461|Drug|Carboplatin, Bevacizumab and Pemetrexed|Chemotherapy was given for 2 cycles after maximal response. Patients were taken off study at the time of progression. If the patient had stable disease or better, as a response, then the patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first. Computed tomography (CT) scans were be done every 12 weeks during the maintenance phase.
11998449|NCT00604448|Other|Dietary advise|Subjects in energy-restricted group will follow dietician advise to keep a conventional energy restriction diet.
11998450|NCT00604448|Other|Diet enriched with a meal containing pulses|Subjects in pulse group will consume the commercially available pulses for 8 weeks
11998451|NCT00604435|Drug|docetaxel and epirubicin|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles
11998452|NCT00604435|Drug|docetaxel and epirubicin plus endostatin|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
11998453|NCT00604409|Radiation|SIRT|Undergo SIRT
11998454|NCT00604409|Drug|capecitabine|Given PO
11998455|NCT00604396|Drug|insulin detemir|
11998456|NCT00604396|Drug|insulin NPH|
11998457|NCT00604383|Drug|ruboxistaurin|32-mg tablet, orally, daily, up to 42 months
11998458|NCT00604383|Drug|placebo|1 tablet, orally, daily, up to 42 months
11998459|NCT00604357|Drug|anti-CD 25 mAb, Sirolimus, MMF|"Prior to reperfusion: 500 mg Prednisolone After OLT: anti-CD25-mAB (basiliximab 20 mg on day 0 and day 4 after the procedure)
~MMF 2 g/d, 2 applications per day i.v., later conversion to oral intake)
~Earliest, on day 10 after LT Sirolimus: 5 mg/d, thereafter a dosage of 2 mg/d (4 and 8 ng/mL)
~Steroids: 1mg/kg BW (tapered every 2 days for 5 mg to a dosage of 20 mg, 2.5 mg every two days to 7.5 mg, reduced to 5 mg and 2.5 mg for 1 week each and eliminated thereafter)."
11998460|NCT00604344|Drug|insulin detemir|
11998461|NCT00604344|Drug|insulin NPH|
11998462|NCT00604331|Drug|Pyruvate|sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.
11998463|NCT00604318|Drug|rhTSH|The patients will be randomised to either T3 (Liothyronine) pause related to the first radioiodine treatment and Thyrogen injection with continuing Liothyronine treatment related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.
11998464|NCT00604305|Device|Acrysof|Monofocal IOL
11998465|NCT00604305|Device|Acuity's AIOL|Accommodating IOL
11998466|NCT00604279|Drug|Paliperidone palmitate (R092670)|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.
11998467|NCT00604279|Drug|Risperidone|Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
11998468|NCT00604253|Drug|insulin detemir|
11998469|NCT00604253|Drug|insulin NPH|
11998470|NCT00604227|Other|Hypoxic Exposure|ascent to 4559 m within 24 h without prior acclimatization
11998471|NCT00604214|Drug|Drotrecogin alfa (activated)|24 microgram/kilogram/hour, intravenous, 96 hours (hr)
11998472|NCT00604214|Drug|Placebo|0.9% sodium chloride, intravenous, 96 hours
11998473|NCT00604201|Biological|Umbilical Cord Blood|unrelated umbilical cord blood will be co-infused with haploidentical CD34-selected cells from a related donor for treatment of severe aplastic anemia and myelodysplastic syndrome.
11998474|NCT00604188|Drug|Suboxone (SCH 000484)|2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
11998475|NCT00604188|Drug|Subutex (SCH 028444)|2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
11998476|NCT00604175|Biological|Quadrivalent HPV vaccine|Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.
11998477|NCT00604162|Device|PillCam COLON|The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.
11998478|NCT00604162|Procedure|Standard colonoscopy|Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
11998479|NCT00604136|Biological|tumor infiltrating lymphocytes|Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro. Tumor infiltrating lymphocytes from these cultures will be assessed for tumor reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x2 days IV)and fludarabine (25 mg/mE2/day IV x5days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 10E9 tumor-reactive lymphocytes followed by high dose IL-2 (720,000 IU/kg/dose IV every 8 hours for up to 15 doses).
11998480|NCT00604123|Drug|JNJ-17166864|JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.
11998481|NCT00604123|Drug|Placebo|Placebo nasal spray twice daily for 2 weeks.
11998482|NCT00604110|Other|Biventricular pacing post cardiac surgery|Determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF<45%), is hemodynamically favourable.
11998483|NCT00604097|Behavioral|Attachment-Based Family Therapy|12-16 week family-based therapy
11998484|NCT00604097|Behavioral|Enhanced Usual Care|Rapid referral to community outpatient care with weekly monitoring of symptoms by study team
11998485|NCT00604084|Drug|Ivermectin|Ivermectin 200ug/kg, 1 dose Q 6 months x 2, total duration = 12 months
11998486|NCT00604084|Drug|Permethrin 5% lotion|apply lotion to entire body, excluding head, at bedtime, rinse off following morning, wait one week, repeat application for a total of 2 applications, PRN frequency, NMT 6 applications in 12 months, total duration = 12 months.
11998487|NCT00604058|Biological|Inactivated Poliomyelitis vaccine (IMOVAX)|Fractional dose (1/5th) 0.1 mL, intradermally
11998488|NCT00604058|Biological|Inactivated Poliomyelitis vaccine (IMOVAX)|A full dose, 0.5 mL, intramuscular
11998489|NCT00604045|Behavioral|Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
11998490|NCT00604045|Behavioral|Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
11998491|NCT00604032|Drug|Atralin (tretinoin) Gel, 0.05%|Assess potential of tretinoin gel, 0.05% to produce phototoxic reactions, measured 24 and 48 hours after UV radiation of drug on the skin.
11998492|NCT00604019|Drug|Dopamine|Dopamine 5-20 mcg/kg/min to pre-determined max of 20
11998493|NCT00604019|Drug|Norepinephrine|Norepinephrine 5-20 mcg/min, to a pre-determined max of 20
11998494|NCT00604006|Drug|Spironolactone|25 mg tablets (placed in capsules for blinding) once daily.
11998495|NCT00604006|Drug|Placebo|Placebo (lactose in capsules for blinding) once daily
11998496|NCT00603993|Biological|Adalimumab|40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
11998497|NCT00603980|Drug|Inhaled placebo + oral placebo|Inhaled Staccato placebo + oral placebo
11998498|NCT00603980|Drug|Inhaled alprazolam 0.5 mg|Inhaled Staccato alprazolam 0.5 mg + oral placebo
11998499|NCT00603980|Drug|Inhaled alprazolam 1 mg|Inhaled Staccato alprazolam 1 mg + oral placebo
11998500|NCT00603980|Drug|Inhaled alprazolam 2 mg|Inhaled Staccato alprazolam 2 mg + oral placebo
11998501|NCT00603980|Drug|Oral alprazolam 1 mg|Oral alprazolam 1 mg + Inhaled placebo
11998502|NCT00603980|Drug|Oral alprazolam 2 mg|Oral alprazolam 2 mg + Inhaled placebo
11998503|NCT00603980|Drug|Oral alprazolam 4 m|Oral alprazolam 4 mg + Inhaled placebo
11998504|NCT00603980|Drug|Oral alprazolam 2 mg qualifying session|Qualifying session (2 mg oral alprazolam)
11998505|NCT00603980|Drug|Oral placebo qualifying session|Qualifying control session (oral placebo)
11998506|NCT00603967|Procedure|Dual x-ray absorptiometry (DXA)|Baseline, 6 months, and 12 months
11998507|NCT00603967|Procedure|Blood draw|Baseline - genotyping Baseline, 6 months, and 12 months - markers of bone turnover and hormonal assays
11998508|NCT00603967|Behavioral|Questionnaire|"Menopausal symptom questionnaire - baseline, 3 months, 6 months, 12 months
~Cognitive tests - baseline, 6 months, 12 months
~Depression assessment - baseline, 6 months, 12 months
~Dietary calcium intake questionnaire - baseline"
11998509|NCT00603954|Drug|Conditioning regimen TBI + Fludarabine|2 Gy TBI, Fludarabine 90 mg/m²
11998510|NCT00603954|Drug|Conditioning regimen II (TLI 8 Gy + ATG [Thymoglobulin])|TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg
11998511|NCT00603941|Drug|CS-7017|At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.30, or 0.50 mg BID. At Phase 2, CS-7017 will be administered at the recommended phase 2 dose (RP2D).
11998512|NCT00603941|Drug|Paclitaxel|Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.
11998513|NCT00603915|Drug|Gemcitabine|1000mg/m^2 intravenous (IV) day 1 and day 8
11998514|NCT00603915|Drug|Carboplatin/Cisplatin|Area under curve (AUC)=5 (Carboplatin) or 70mg/m^2 (Cisplatin) intravenous (IV) day 1
11998515|NCT00603915|Drug|erlotinib|150mg daily (post GC therapy)
11998516|NCT00603902|Drug|Lorcaserin 10 mg once daily (QD)|Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
11998517|NCT00603902|Drug|Lorcaserin 10 mg twice a day (BID)|Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
11998518|NCT00603902|Drug|Matching Placebo|Matching placebo tablet each morning and evening for a duration of 52 weeks.
11998519|NCT00603889|Biological|Na-ASP-2 Skin Test Reagent|Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
11998520|NCT00603876|Dietary Supplement|Almonds|100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days
11998521|NCT00603863|Biological|IMMU-107 (hPAM4)|90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
11998522|NCT00603850|Device|ForeseeHome|human factor
11998523|NCT00603837|Device|NeoWrap|This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.
11998524|NCT00603837|Device|InfaTherm|A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
11998525|NCT00603824|Drug|fondaparinux|fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg
11998526|NCT00603824|Drug|argatroban or lepirudin|continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range
11998527|NCT00603811|Biological|VAX102 [Flagellin.HuM2e]|dose ranging, 2 i.m. doses given 28 days apart
11998528|NCT00603811|Biological|Placebo|Placebo
11998529|NCT00603798|Drug|Imiquimod cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
11998530|NCT00603798|Drug|Placebo cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
11998531|NCT00603798|Drug|Imiquimod cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
11998532|NCT00603785|Drug|Placebo|Subjects with chronic sinusitis and evidence of atopy and an elevated total IgE (>30 and <700 IU/ml) will be randomized to receive placebo treatment for 6 months.
11998533|NCT00603785|Drug|Xolair|Subjects with chronic sinusitis and evidence of atopy and an elevated total IgE (>30 and <700 IU/ml) will be randomized to receive Xolair treatment for 6 months.
11998534|NCT00603772|Drug|Atralin (tretinoin) gel, 0.05%|Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.
11998535|NCT00603759|Drug|celecoxib|100 mg qid
11998536|NCT00603759|Drug|placebo|1 cap qid
11998537|NCT00603746|Drug|GW685698X|GW685698X
11998538|NCT00603733|Drug|5-ASA (5-Aminosalicylate)|500 mg tablet (modified extended release)
11998539|NCT00603733|Drug|5-ASA (5-Aminosalicylate)|500 mg tablet
11998540|NCT00603720|Drug|L-NAME|nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging
11998541|NCT00603720|Drug|L-Arginine|aids in nitric oxide production
11998542|NCT00603720|Drug|Phenylephrine|alpha agonist; 10 μg/kg/min infusion during PET study
11998543|NCT00603681|Drug|Polyethylene glycol 4000|powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
11998544|NCT00603681|Drug|Polyethylene glycol 4000 with electrolytes|granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
11998545|NCT00603668|Biological|milatuzumab|two or three times a week dosing of hLL1 for a total of 4 weeks
11998546|NCT00603655|Other|Low glycemic load diet|Low glycemic load diet
11998547|NCT00603655|Other|High glycemic load diet|High glycemic load diet
11998548|NCT00603642|Drug|Placebo|Subcutaneously administered, once a week, for 12 weeks
11998549|NCT00603642|Drug|AMG 531|Subcutaneously administered, once a week, for 12 weeks
11998707|NCT00602602|Drug|gemcitabine hydrochloride|
11998550|NCT00603616|Drug|Placebo Comparator|Matching oral placebo pills to be taken twice daily for a total of 8 weeks
11998551|NCT00603616|Drug|Rifaximin|Oral rifaximin 550mg to be taken twice daily for a total of 8 weeks
11998552|NCT00603603|Other|80% inhaled oxygen via non-rebreather mask|Patients randomized to treatment group will receive 80% inhaled oxygen via a non-rebreather face mask during their cesarean section and for 2 hours afterwards.
11998553|NCT00603603|Other|30% inhaled oxygen via nasal cannula|Patients randomized to treatment group will receive 30% inhaled oxygen via a nasal cannula (standard of care)during their cesarean section.
11998554|NCT00603590|Drug|Polypill|Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily
11998555|NCT00603590|Drug|Placebo drug|Inactive tablet Once a day Identical in appearance to intervention drug
11998556|NCT00603577|Drug|Placebo|Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
11998557|NCT00603577|Drug|Xaliproden|1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
11998558|NCT00603564|Procedure|Castar Starmed (CPAP) delivered by a helmet|Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
11998559|NCT00603538|Drug|CP-751,871 + carboplatin + paclitaxel|Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.
11998560|NCT00603525|Drug|Ofatumumab|1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each treatment cycle consisting of two IV infusion taken 14 days apart. A total of 8 infusion cycles given over a 144 week period
11998561|NCT00603525|Drug|Placebo|1000 mL sterile, pyrogen free 0.9% NaCl. A treatment cycle consisting of two IV infusion taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period
11998562|NCT00603512|Drug|Placebo|0 mg BID, 3 blinded tablets administered BID for 12 weeks
11998563|NCT00603512|Drug|CP-690,550|10 mg BID, 3 blinded tablets administered BID for 12 weeks
11998564|NCT00603512|Drug|CP-690,550|1 mg BID, 3 blinded tablets administered BID for 12 weeks
11998565|NCT00603512|Drug|CP-690,550|3 mg BID, 3 blinded tablets administered BID for 12 weeks
11998566|NCT00603512|Drug|CP-690,550|5 mg BID, 3 blinded tablets administered BID for 12 weeks
11998567|NCT00603499|Dietary Supplement|Magnesium chloride|Subjects in the intervention group received 2.5 gr of MgCl2 daily during 4 months, from a solution solution containing 50 gr of MgCl2 by 1000 ml.
11998568|NCT00603499|Other|Placebo|Subjects in the control group received inert placebo once per day during 4 months
11998569|NCT00603486|Device|GE DINAMAP with SuperSTAT algorithm monitor|Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)
11998570|NCT00603473|Drug|gabapentin|Orally administered gabapentin
11998571|NCT00603460|Biological|DCVax-L and T Cells|"Arm A
~Optional DCVax-L prior to chemotherapy
~Apheresis
~Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide)
~Infusion of activated T cells
~DCVax-L vaccine
~End of study visit
~Arm B
~Optional DCVax-L prior to chemotherapy
~Apheresis
~Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide)
~Infusion of activated T cells
~DCVax-L vaccine
~Oral cyclophosphamide (one week on/one week off) for a total for a total of 6 weeks
~End of study visit"
11998572|NCT00603447|Drug|Carfilzomib|Carfilzomib for Injection was administered intravenously over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for the first 12 cycles. Each dose of Carfilzomib for Injection was normalized to body surface area.
11998573|NCT00603447|Drug|Lenalidomide|Lenalidomide was administered orally on Days 1 to 21 of each 28-day cycle.
11998574|NCT00603447|Drug|Dexamethasone|Dexamethasone 40 mg orally or intravenous equivalent was administered 30 minutes to 4 hours before carfilzomib on Days 1, 8, and 15, as well as on Day 22 of each 28-day cycle.
11998575|NCT00603434|Drug|OROS-MPH|18 mg bid on days 1 and 2
11998576|NCT00603434|Drug|OROS-MPH|27mg bid on days 3 and 4
11998577|NCT00603434|Drug|OROS-MPH|35 mg bid on days 5-9
11998578|NCT00603421|Other|24 hour phone line|24 hour phone line is available as soon as the patient himself feels necessary. This phone line is supported by professionals of mental health, all specialised in borderline personality disorder
11998579|NCT00603421|Other|treatment as usual|Treatment as usual
11998580|NCT00603408|Drug|Cisplatin|
11998581|NCT00603408|Radiation|Radiation Therapy|
11998582|NCT00603408|Procedure|Mastectomy|(RECOMMENDED BUT NOT REQUIRED)
11998583|NCT00603395|Device|ReCap Total Hip Resurfacing System|This is a hip resurfacing system.
11998584|NCT00603382|Drug|GW685698X|GW685698X
11998585|NCT00603382|Drug|Placebo|placebo comparator
11998586|NCT00603369|Behavioral|group intervention|13-session intervention
11998587|NCT00603369|Behavioral|group intervention|2-session intervention
11998588|NCT00603356|Drug|OSI-930 and erlotinib|OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
11998589|NCT00603343|Drug|Mictonetten 5 mg, coated tablet|propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)
11998590|NCT00603343|Drug|placebo|placebo corresponding to body weight
11998591|NCT00603330|Biological|Mesenchymal stem cells|Mesenchymal Stem Cell infusion
11998592|NCT00603317|Drug|Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo|Amoxicillin : 2g twice daily Clavulanic acid : 125 mg twice daily
11998593|NCT00603317|Drug|Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid|Amoxicillin : 2g twice daily Clavulanic acid : 125mg twice daily seven consecutive days
11998594|NCT00603304|Drug|Saw Palmetto - first 24 weeks|Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
11998595|NCT00603304|Drug|Placebo - first 24 weeks|Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
11998596|NCT00603304|Drug|Saw Palmetto - weeks 24 - 48|Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
11998597|NCT00603304|Drug|Placebo - weeks 24 - 48|Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.
11998708|NCT00602602|Drug|oxaliplatin|
11998598|NCT00603304|Drug|Saw Palmetto - weeks 48 - 72|Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
11998599|NCT00603304|Drug|Placebo - weeks 48 - 72|Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
11998600|NCT00603291|Drug|Lorcaserin 10 mg once daily (QD)|Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
11998601|NCT00603291|Drug|Lorcaserin 10 mg twice a day (BID)|Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
11998602|NCT00603291|Drug|Matching Placebo|Matching placebo tablet each morning and evening for a duration of 52 weeks.
11998603|NCT00603278|Drug|GW685698X|GW685698X
11998604|NCT00603278|Drug|placebo|placebo
11998605|NCT00603265|Drug|ADL5859|
11998606|NCT00603265|Drug|Duloxetine|
11998607|NCT00603265|Drug|Placebo|
11998608|NCT00603252|Biological|Twinrix|
11998609|NCT00603252|Biological|Engerix-B|
11998610|NCT00603252|Biological|Havrix|
11998611|NCT00603252|Biological|HBVAXPRO|
11998612|NCT00603252|Biological|Vaqta|
11998613|NCT00603239|Drug|exenatide|subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
11998614|NCT00603239|Drug|placebo|subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day
11998615|NCT00603213|Procedure|Blood Volume Analysis, Echocardiogram|"Blood Volume Analysis: The use of radioactive tracer to determine plasma volume and red cell mass.
~Echocardiogram is an ultrasound of the heart."
11998616|NCT00603187|Drug|Acyline|20 mg GIPET enhanced oral dose, daily for 7-days
11998617|NCT00603174|Device|neurally adjusted ventilatory assist (NAVA)|Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate.
11998618|NCT00603135|Drug|first-line i/v-levetiracetam|No effect after 30 min, standard therapy with f.e. lorazepam for NCSE
11998619|NCT00603122|Behavioral|ascent protocol|ascent protocol for the two groups has different acclimatization time
11998620|NCT00603109|Drug|rimonabant|rimonabant capsule 20 mg per day PO for 6 months
11998621|NCT00603109|Drug|placebo|Subjects take 20 mg placebo capsule one a day PO for 6 months
11998622|NCT00603096|Device|GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare|The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
11998623|NCT00603083|Drug|Ropivacaine, Ketorolac and Adrenalin|The local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation.
11998624|NCT00603083|Drug|Placebo|This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation.
11998625|NCT00603070|Other|E-prescribing system|Transition from home-grown to vendor-based ambulatory e-prescribing systems
11998626|NCT00603070|Other|Electronic transmission of medication discharge lists|Patient discharge medication lists will be transmitted upon discharge from their inpatient medical record to their outpatient medical record and their outpatient provider will be notified of this transmission.
11998627|NCT00603044|Drug|fluticasone furoate|treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
11998628|NCT00603031|Other|glucagon like peptide -1|continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes
11998629|NCT00603031|Other|NaCl|infusion with NaCl for 120 minutes as placebo-arm
11998630|NCT00603031|Other|glucose dependent insulinotropic polypeptide|continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.
11998631|NCT00603018|Drug|Fluoxetine|8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
11998632|NCT00603005|Device|Use of TravAlert dosing aid with or without drop guider|Each patient will use a dosing aid and/or drop guider for 6 months
11998633|NCT00602979|Device|Macintosh laryngoscope|Used during laryngoscopy to facilitate intubation.
11998634|NCT00602979|Device|Airtraq® Optical Laryngoscope|Used during laryngoscopy to facilitate intubation.
11998635|NCT00602979|Device|Storz DCI Video Laryngoscope®|Used during laryngoscopy to facilitate intubation
11998636|NCT00602979|Device|GlideScope® Video Laryngoscope|Used during laryngoscopy to facilitate intubation
11998637|NCT00602979|Device|McGRATH® Video Laryngoscope|Used during laryngoscopy to facilitate intubation
11998638|NCT00602953|Other|No intervention planned.|This is a cross-sectional observational study, no intervention is planned.
11998639|NCT00602940|Procedure|Acupuncture|12 treatments over 8 weeks
11998640|NCT00602940|Procedure|Sham Acupuncture|12 treatments over 8 weeks
11998641|NCT00602927|Drug|Varenicline|Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily
11998642|NCT00602927|Drug|Placebo|Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.
11998643|NCT00602914|Device|MicronJet|The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.
11998644|NCT00602914|Device|MicronJet|MicronJet, Intradermal Injection
11998645|NCT00602901|Other|HVLA-SM|High-velocity low amplitude spinal manipulation (HVLA-SM)
11998646|NCT00602901|Other|LVVA-SM|Low-velocity variable amplitude spinal manipulation (LVVA-SM)
11998647|NCT00602901|Drug|Usual medical care|Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.
11998648|NCT00602862|Drug|Sorafenib|Sorafenib 200 mg 2dd2 po for 4 weeks before surgery
11998649|NCT00602862|Drug|111Indium-bevacizumab|100 MBq / 1 mg 111Indium/bevacizumab iv
11998650|NCT00602862|Drug|111Indium-cG250|100 MBq / 10 mg 111Indium-cG250 iv
11998651|NCT00602849|Drug|Sertraline|
11998652|NCT00602836|Biological|Rituximab|Cycle 1: 100 mg by IV on day 1, 375 mg/m^2 by IV on day 2 Cycle 2-6: 375 mg/m^2 by IV on day 1 (every 21 days)
11998653|NCT00602836|Drug|Cyclophosphamide|600 mg/m^2 by IV on day 1 of cycles 1-6 (every 21 days)
11998654|NCT00602836|Drug|Lenalidomide|Cycle 7: 5 mg orally daily on days 1-28 Cycle 8: 10 mg orally daily on days 1-28 as tolerability permits Cycle 9 and beyond: 10 mg orally daily on days 1-28
11998655|NCT00602836|Drug|Pentostatin|2 mg/m^2 by IV on day 1 of cycles 1-6 (every 21 days)
11998656|NCT00602797|Drug|Paclitaxel|Given IV
11998657|NCT00602797|Other|Quality-of-Life Assessment|Ancillary studies
11998658|NCT00602797|Other|Questionnaire Administration|Ancillary studies
11998659|NCT00602797|Drug|Vinorelbine Tartrate|Given IV
11998660|NCT00602784|Biological|IC41|
11998661|NCT00602771|Drug|tipifarnib|Given orally
11998662|NCT00602771|Drug|etoposide|Given orally
11998663|NCT00602758|Behavioral|Motivational interviewing with cognitive behavioral therapy|Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence.
11998664|NCT00602758|Behavioral|Modified directly observed therapy|From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose. The frequency of observed doses begins to taper at Week 17 through to Week 24.
11998665|NCT00602745|Drug|S-1|oral administration
11998666|NCT00602745|Drug|5-Fluorouracil|intravenous bolus
11998667|NCT00602732|Behavioral|The Reach Out for a Safe Environment (ROSE) program|Participants in the ROSE program will receive a course on managing stress and negative feelings and will learn how to access resources for help. The ROSE program involves four 90-minute group sessions over a 4-week period prior to delivery. Participants will also attend one 50-minute booster session within 4 weeks prior to delivery of their babies.
11998668|NCT00602732|Behavioral|Enhanced care as usual (ECU)|Participants in ECU will receive the usual medical care provided for pregnant women at their prenatal clinic. Participants will also receive educational material and a list of treatment resources for depression.
11998669|NCT00602719|Drug|Zolpidem|
11998670|NCT00602706|Biological|sargramostim|
11998671|NCT00602706|Drug|melphalan|
11998672|NCT00602706|Procedure|autologous hematopoietic stem cell transplantation|
11998673|NCT00602706|Procedure|peripheral blood stem cell transplantation|
11998674|NCT00602706|Radiation|samarium Sm 153 lexidronam pentasodium|
11998675|NCT00602693|Biological|umbilical cord blood transplantation|Infusion of umbilical cord blood
11998676|NCT00602693|Drug|Allopurinol|Administration begins Day -7 through Day 0, tablet or powder prescribed on an individual basis.
11998677|NCT00602693|Drug|fludarabine phosphate|40 mg/m^2 intravenously over 1 hour on Days -6, -5, -4, -3, -2
11998678|NCT00602693|Drug|Cyclophosphamide|50 mg/kg intravenous over 2 hours on Day -6
11998679|NCT00602693|Radiation|Total body irradiation|200 cGy on Day -1
11998680|NCT00602693|Biological|Treg infusion|Infusion of T regulatory cells on Day +1 (also Day +15 for Dose level 5 only). Dose escalation ranges include 1, 3, 10, 30, 100, 300 1000, and 300 x 10^5 Treg/kg.
11998681|NCT00602693|Drug|Sirolimus|Beginning on day -3 and continuing until day +100, patients receive sirolimus intravenously (IV) with 8-12 mg oral loading dose followed by a single dose of 4mg/day with a target serum concentration of 3-12 mg/mL with a taper until day +180.
11998682|NCT00602680|Drug|SSR180711C|duration of treatment: 4 weeks
11998683|NCT00602680|Drug|donepezil|duration of treatment: 4 weeks
11998684|NCT00602680|Drug|placebo|duration of treatment: 4 weeks
11998685|NCT00602667|Drug|Induction Chemotherapy|All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.
11998686|NCT00602667|Drug|Low-Risk Therapy|Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
11998687|NCT00602667|Drug|High-Risk Therapy|High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
11998688|NCT00602667|Drug|Intermediate-Risk Therapy|"Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
~Note: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan."
11998689|NCT00602641|Other|Laboratory Biomarker Analysis|Optional correlative studies
11998690|NCT00602641|Drug|Lenalidomide|Given PO
11998691|NCT00602641|Drug|Melphalan|Given PO
11998692|NCT00602641|Drug|Prednisone|Given PO
11998693|NCT00602641|Other|Quality-of-Life Assessment|Ancillary studies
11998694|NCT00602641|Drug|Thalidomide|Given PO
11998695|NCT00602628|Other|questionnaire administration|
11998696|NCT00602628|Procedure|adjuvant therapy|
11998697|NCT00602628|Procedure|biopsy|
11998698|NCT00602628|Procedure|computed tomography|
11998699|NCT00602628|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
11998700|NCT00602628|Procedure|magnetic resonance imaging|
11998701|NCT00602628|Procedure|therapeutic conventional surgery|
11998702|NCT00602628|Procedure|ultrasound imaging|
11998703|NCT00602628|Radiation|radiation therapy|
11998704|NCT00602615|Drug|Torsemide|
11998711|NCT00602602|Procedure|conventional surgery|
11998712|NCT00602602|Procedure|endoscopic biopsy|
11998713|NCT00602602|Procedure|laparoscopy|
11998714|NCT00602602|Radiation|radiation therapy|
11998715|NCT00602589|Drug|Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations|
11998716|NCT00602576|Drug|sorafenib tosylate|Given orally
11998717|NCT00602576|Drug|temozolomide|Given orally
11998718|NCT00602563|Behavioral|AMP|The AMP is a computer-delivered attention modification protocol designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes twelve 20-min sessions delivered over a 6-week period. During each session, participants will see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Threat). 192 trials include one neutral word and one threat word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one threat word (i.e., 80% of the trials), the probe always follows the neutral word.
11998719|NCT00602563|Behavioral|Applied Relaxation (AR)|Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways to reduce the physiological cues associated with anxiety and worry (Öst, 1987; Siev & Chambless, 2007)
11998720|NCT00602563|Behavioral|Clinical Monitoring (CM)|participants assigned to the clinical monitoring (CM) condition will receive the same information about the nature of GAD provided to participants in the active conditions
11998721|NCT00602563|Behavioral|Combining the AMP and AR|The AMP is a computer-delivered attention modification protocol designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes twelve 20-min sessions delivered over a 6-week period. During each session, participants will see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Threat). 192 trials include one neutral word and one threat word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one threat word (i.e., 80% of the trials), the probe always follows the neutral word. Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways
11998722|NCT00602550|Drug|Zidovudine|
11998723|NCT00602537|Drug|Venlafaxine|75 to 375 mg
11998724|NCT00602537|Drug|Lithium Carbonate|300 to 2400 mg
11998725|NCT00602524|Drug|Pilocarpine|
11998726|NCT00602511|Drug|Bortezomib|"Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles
~Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity"
11998727|NCT00602511|Drug|Thalidomide|"Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day
~Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity"
11998728|NCT00602498|Drug|Clarithromycin|
11998729|NCT00602485|Other|Action Control Education|30 minute educational intervnetion
11998730|NCT00602472|Drug|linagliptin|active
11998731|NCT00602472|Drug|placebo|placebo to linagliptin 5 mg
11998732|NCT00602459|Drug|Cyclophosphamide|Given IV
11998733|NCT00602459|Drug|Fludarabine Phosphate|Given IV or PO
11998734|NCT00602459|Other|Laboratory Biomarker Analysis|Correlative studies
11998735|NCT00602459|Drug|Lenalidomide|Given PO
11998736|NCT00602459|Biological|Rituximab|Given IV
11998737|NCT00602446|Drug|deferasirox|20 mg/kg once daily orally for 6 months
11998738|NCT00602420|Drug|naproxen|Oral naproxen twice daily for 5-8 days.
11998739|NCT00602420|Other|placebo|Oral placebo twice daily for 5-8 days.
11998740|NCT00602407|Drug|Cilostazol|
11998741|NCT00602394|Drug|Lithium|
11998742|NCT00602381|Drug|Lithium|
11998743|NCT00602368|Other|histological technique|
11998744|NCT00602368|Other|laboratory biomarker analysis|
11998745|NCT00602368|Procedure|colposcopic biopsy|
11998746|NCT00602368|Procedure|colposcopy|
11998747|NCT00602368|Procedure|light-scattering spectroscopy|
11998748|NCT00602368|Procedure|loop electrosurgical excision procedure|
11998749|NCT00602355|Drug|Sertraline|"Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific mother-crafting techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care."
11998750|NCT00602355|Drug|Placebo|"Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific mother-crafting techniques as those taking sertraline."
11998751|NCT00602355|Behavioral|Interpersonal psychotherapy (IPT)|IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.
11998752|NCT00602355|Behavioral|Clinical management|Clinical management includes treatment as usual for those receiving medication for depression.
11998753|NCT00602355|Behavioral|Mothercrafting|Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care
11998754|NCT00602342|Drug|Terbinafine|
11998755|NCT00602329|Biological|bevacizumab|Given IV
11998756|NCT00602329|Drug|fluorouracil|Given IV
11998757|NCT00602329|Drug|leucovorin calcium|Given IV
11998758|NCT00602329|Drug|oxaliplatin|Given IV
11998759|NCT00602316|Drug|gadolinium-chelate|
11998760|NCT00602316|Procedure|conventional surgery|
11998761|NCT00602316|Procedure|magnetic resonance imaging|
11998762|NCT00602316|Procedure|magnetic resonance spectroscopic imaging|
11998763|NCT00602303|Drug|Torsemide|
11998824|NCT00601965|Drug|Escitalopram|20 mg daily oral escitalopram
11998825|NCT00601965|Drug|Placebo|Placebo pill of daily oral escitalopram
11998826|NCT00601965|Behavioral|Cognitive behavioral therapy (CBT)|16 weekly 1-hour sessions
11998873|NCT00601718|Drug|ifosfamide|Given IV
11998764|NCT00602290|Drug|Citalopram|Citalopram dosage will be 20 to 60 mg a day prior to FDA warning limiting it to 20-40 mg in 2011. Participants will begin taking one 20-mg capsule once per day for 4 weeks, and this dosage may be increased or decreased depending on the participant's response to the medication or side-effect profile. Participants will continue on their assigned dosage of citalopram that will be titrated up after week 4 if clinical global impressions (CGI) scores were > 2 until treatment completion.
11998765|NCT00602290|Drug|Methylphenidate (MPH)|MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule (2.5 mg) twice per day, which will be increased to a maximum up to 8 x 2.5 mg capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
11998766|NCT00602290|Drug|Placebo|Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day matching methylphenidate, and 1-3 capsules matching citalopram. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
11998767|NCT00602277|Other|Laboratory Biomarker Analysis|Correlative studies
11998768|NCT00602277|Biological|Wild-type Reovirus|
11998769|NCT00602251|Drug|Terbinafine|
11998770|NCT00602225|Drug|clofarabine|Given IV
11998771|NCT00602225|Drug|cytarabine|Given IV
11998772|NCT00602225|Biological|filgrastim|Given subcutaneously
11998773|NCT00602212|Behavioral|relaxation with virtual reality (VR)|VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves
11998774|NCT00602212|Behavioral|relaxation and biofeedback virtual reality|The patients experienced the same protocol described above, but with the biofeedback support. Specifically, in the sessions with the therapist, HR variations were used to modify specific features of the virtual environment:
11998775|NCT00602199|Drug|ABT-510|
11998776|NCT00602199|Other|immunoenzyme technique|
11998777|NCT00602199|Other|immunohistochemistry staining method|
11998778|NCT00602199|Other|laboratory biomarker analysis|
11998779|NCT00602199|Other|pharmacological study|
11998780|NCT00602199|Procedure|biopsy|
11998781|NCT00602186|Drug|tamsolusin|0.4 mg /day
11998782|NCT00602186|Drug|prazosin|1 mg/day
11998783|NCT00602173|Drug|Cilostazol|
11998784|NCT00602160|Drug|FAHF-2 (TM)|"We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group.
~Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy."
11998785|NCT00602147|Other|laboratory biomarker analysis|Blood or cheek cells wil be collected.
11998786|NCT00602134|Drug|6-Mercaptopurine|
11998787|NCT00602108|Procedure|adjuvant therapy|
11998788|NCT00602108|Procedure|conventional surgery|
11998789|NCT00602108|Radiation|hypofractionated radiation therapy|
11998790|NCT00602108|Radiation|intraoperative radiation therapy|
11998791|NCT00602095|Drug|misoprostol|0.025mg tablet vaginally every 4 hour until progress
11998792|NCT00602095|Drug|dinoprostone|2mg vaginal gel every 6 hours until progress
11998793|NCT00602095|Device|Bard Catheter (balloon catheter)|Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated
11998794|NCT00602082|Drug|capecitabine|
11998795|NCT00602082|Drug|cisplatin|
11998796|NCT00602082|Drug|streptozocin|
11998797|NCT00602082|Genetic|DNA analysis|
11998798|NCT00602082|Genetic|RNA analysis|
11998799|NCT00602082|Genetic|protein analysis|
11998800|NCT00602082|Genetic|proteomic profiling|
11998801|NCT00602082|Other|laboratory biomarker analysis|
11998802|NCT00602069|Behavioral|Helping to Overcome PTSD through Empowerment (HOPE)|HOPE includes a maximum of 16 sessions of cognitive behavioral therapy. The sessions will emphasize stabilization and empowerment, both of which are identified as important goals by the theoretical and empirical literature on abused women and PTSD.
11998803|NCT00602069|Behavioral|Treatment as usual|Treatment as usual includes standard shelter services for abused women.
11998804|NCT00602056|Other|Redesigned immunization card|A low cost nad simplified redesigned immunization card
11998805|NCT00602056|Other|Center based education to mothers/caregivers|A 2-3 minute center based education to mothers/caregivers
11998806|NCT00602056|Other|Redesigned immunization card with center based education to mother/caregivers|Redesigned immunization card with center based education to mother/caregivers
11998807|NCT00602043|Radiation|F-18 16 alpha-fluoroestradiol|Undergo [^18F] FES PET
11998808|NCT00602043|Radiation|fludeoxyglucose F 18|Undergo standard clinical FDG PET/CT
11998809|NCT00602043|Procedure|positron emission tomography|Undergo [^18F] FES PET
11998810|NCT00602043|Procedure|positron emission tomography|Undergo standard clinical FDG PET/CT
11998811|NCT00602043|Procedure|computed tomography|Undergo standard clinical FDG PET/CT
11998812|NCT00602043|Other|laboratory biomarker analysis|Correlative studies
11998813|NCT00602030|Drug|entinostat|"Dose cohort 1: SNDX-275 5mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles)
~Dose cohort 2: SNDX-275 10mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles)"
11998814|NCT00602030|Drug|SNDX-275|entinostat 5mg or 10mg (determined by Lead in study findings) on days 1 and 15 of a 28-day cycle until progression or unacceptable toxicity develops; maximum of 6 cycles
11998815|NCT00602030|Drug|erlotinib|erlotinib 150mg PO QD
11998816|NCT00602017|Drug|Amlodipine|
11998817|NCT00602004|Drug|losartan|losartan 50 mg a day
11998818|NCT00601991|Biological|VEGF Trap|Drug under investigation
11998819|NCT00601991|Procedure|Bone marrow biopsy|To determine response to treatment
11998820|NCT00601991|Procedure|bone marrow aspiration|To determine response to treatment
11998821|NCT00601991|Procedure|Venipuncture|For test of free VEGF Trap compared to bound VEGF Trap and for routine clinical testing during treatment
11998822|NCT00601978|Drug|carbidopa/levodopa|
11998823|NCT00601978|Drug|Carbidopa/Levodopa/Entacapone|
11998827|NCT00601952|Behavioral|Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
11998828|NCT00601952|Behavioral|Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
11998829|NCT00601939|Behavioral|Psychoeducational intervention (PEI)|PEI consists of 10 culturally competent group empowerment psychoeducational sessions. The sessions are directed by a treatment manual and are co-led by two therapists. The sessions are guided by the theory of triadic influence (TTI) model, which incorporates cultural-environmental influences, social-situational influences, and intrapersonal influences into treatment.
11998830|NCT00601939|Behavioral|Enhanced treatment as usual (ETAU)|ETAU contains an adherence protocol plus access to weekly support group and a resource room.
11998831|NCT00601926|Biological|bevacizumab|15 mg/kg over 90 minutes every 3 weeks
11998832|NCT00601913|Drug|erlotinib hydrochloride|
11998833|NCT00601913|Genetic|protein analysis|
11998834|NCT00601913|Genetic|western blotting|
11998835|NCT00601913|Other|immunohistochemistry staining method|
11998836|NCT00601913|Other|laboratory biomarker analysis|
11998837|NCT00601913|Other|liquid chromatography|
11998838|NCT00601913|Other|mass spectrometry|
11998839|NCT00601913|Procedure|neoadjuvant therapy|
11998840|NCT00601913|Procedure|therapeutic conventional surgery|
11998841|NCT00601900|Biological|Bevacizumab|Given IV
11998842|NCT00601900|Other|Laboratory Biomarker Analysis|Correlative studies
11998843|NCT00601900|Drug|Letrozole|Given PO
11998844|NCT00601900|Other|Questionnaire Administration|Ancillary studies
11998845|NCT00601900|Drug|Tamoxifen Citrate|Given PO
11998846|NCT00601887|Drug|Meloxicam|
11998847|NCT00601874|Drug|Pilocarpine|
11998848|NCT00601861|Drug|recombinant interleukin-21|Fixed and equal dose for s.c. injection, 3 times weekly
11998849|NCT00601848|Drug|chemotherapy|
11998850|NCT00601848|Drug|porfimer sodium|
11998851|NCT00601848|Other|immunohistochemistry staining method|
11998852|NCT00601848|Other|laboratory biomarker analysis|
11998853|NCT00601848|Procedure|spectroscopy|
11998854|NCT00601848|Procedure|therapeutic conventional surgery|
11998855|NCT00601835|Biological|Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine|0.5 mL, Intramuscular, single dose
11998856|NCT00601835|Biological|Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine|0.5 mL, Intramuscular, Single dose
11998857|NCT00601822|Behavioral|Cognitive remediation therapy (CRT)|CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.
11998858|NCT00601822|Behavioral|Cognitive behavioral therapy (CBT)|CBT includes 20 to 28 weekly psychotherapy sessions over 6 months, depending on treatment group assignment. CBT sessions aim to change participants' beliefs and behaviors toward eating disorders and to teach ways to handle the daily struggles of an eating disorder.
11998859|NCT00601809|Other|traditional conservative treatment (TT)|In the control group (TT: Traditional Treatment), the patients have been treated as in our daily surgical practice of traditional conservative treatment for ASIO, consisting in nil per os diet, nasogastric tube (NGT) decompression and intravenous fluid resuscitation therapy with electrolytes imbalances correction.
11998860|NCT00601809|Drug|Gastrografin®: G|The study group (GG: Gastrografin Group) received, beyond the traditional conservative treatment for ASIO above mentioned, a G meal with a follow-through study immediately.
11998861|NCT00601796|Biological|Vaccine Treatment|We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
11998862|NCT00601796|Drug|Cyclophosphamide|Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells.
11998863|NCT00601796|Drug|All-trans retinoic acid (ATRA)|All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
11998864|NCT00601770|Biological|IC41|injection
11998865|NCT00601757|Behavioral|The Postpartum Prevention Program (PPP)|PPP includes interpersonal therapy sessions as well as distribution of educational material on postpartum depression. The group sessions will take place during the participant's last trimester of pregnancy. There will be four weekly sessions prior to delivery and one booster session within the first 2 weeks of the postpartum period.
11998866|NCT00601757|Behavioral|Enhanced care as usual (ECU)|ECU includes the usual medical care provided for pregnant women at the Women's Primary Care Center at Women and Infants Hospital as well as the provision of educational material and a list of treatment resources for postpartum depression. Participants will also receive more intensive follow-up in terms of their mental health status than is typically provided in usual practice.
11998867|NCT00601744|Behavioral|Audio-Taped Interview|"Meeting with a research staff member either in person or by phone, lasting 2 to 2 1/2 hours
~Arm 1: Questions about emotional well-being, appearance, coping ability with the cancer, and the types of social relations and support available (such as relationships with friends and family)
~Arm 2: Questions regarding if and how social relations may have been affected by his/her cancer experiences after the orbital exenteration."
11998868|NCT00601744|Behavioral|Questionnaire|5-10 minute questionnaire to be completed after the interview.
11998869|NCT00601731|Biological|MenACWY-CRM197|Blood test, 40-months and 60-months children
11998870|NCT00601731|Biological|Blood test|Blood test, 40-months and 60-months children
11998871|NCT00601718|Drug|vorinostat|Given PO
11998872|NCT00601718|Biological|rituximab|Given IV
11998874|NCT00601718|Drug|carboplatin|Given IV
11998875|NCT00601718|Drug|etoposide|Given IV
11998876|NCT00601718|Other|pharmacological study|Correlative studies
11998877|NCT00601718|Other|laboratory biomarker analysis|Correlative studies
11998878|NCT00601718|Genetic|gene expression analysis|Correlative studies
11998879|NCT00601705|Drug|cisplatin|20 mg/m2/day IV continuous infusion over 24 hours for 96 total hours.
11998880|NCT00601705|Drug|epirubicin hydrochloride|50 mg/m2 IV bolus
11998881|NCT00601705|Drug|fluorouracil|200 mg/m2/day will be given as a continuous intravenous infusion for all 9 weeks, beginning on day 1.
11998882|NCT00601705|Drug|oxaliplatin|130 mg/m2 IV infusion over 2 hours
11998883|NCT00601705|Procedure|adjuvant therapy|Between 6-10 weeks after surgery patients will begin postoperative chemoradiotherapy. Daily radiation therapy fractions of 180-200 cGy will be given to the esophago-gastric bed and draining lymphatic regions to a total dose of 50-55 Gy (60 Gy in the event of an R1 or R2 resection). Concurrent with this radiation, two cycles of chemotherapy will be given, during the first and fourth weeks of the radiation
11998884|NCT00601705|Procedure|neoadjuvant therapy|"Three weeks after discontinuing the fluorouracil (12 weeks after study entry) patients will be fully restaged to assess for a clinical response, and to ensure that there is no contraindication to surgical resection, which will be scheduled for approximately one week later (13 weeks after study entry).
~Surgery will consist of a transthoracic esophagogastrectomy or a total gastrectomy with Roux-en-Y esophagojejunostomy depending on the location and extent of the tumor at surgery. An appropriate lymphadenectomy will be performed. Immediate reconstruction is anticipated if possible."
11998885|NCT00601692|Drug|cisplatin|Given IV
11998886|NCT00601692|Drug|docetaxel|Given IV
11998887|NCT00601692|Drug|irinotecan hydrochloride|Given IV
11998888|NCT00601692|Radiation|radiation therapy|Given 5 days a week for 3 weeks
11998889|NCT00601679|Other|NT-proBNP guided care|knowledge of NT-proBNP results
11998890|NCT00601666|Drug|Zolpidem|
11998891|NCT00601653|Behavioral|Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)|CBT+GN includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling.
11998892|NCT00601653|Behavioral|Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)|CBT+LED includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling that centers upon eating higher volumes of low-calorie foods.
11998893|NCT00601640|Drug|Diclofenac Na gel|Given topically twice daily on days 1-90
11998894|NCT00601640|Drug|Eflornithine HCL ointment|Given topically twice daily on days 1-90
11998895|NCT00601627|Biological|panitumumab|
11998896|NCT00601627|Drug|capecitabine|
11998897|NCT00601627|Drug|fluorouracil|
11998898|NCT00601627|Drug|gemcitabine hydrochloride|
11998899|NCT00601627|Radiation|radiation therapy|
11998900|NCT00601614|Drug|temozolomide|
11998901|NCT00601614|Drug|vandetanib|
11998902|NCT00601614|Other|immunoenzyme technique|
11998903|NCT00601614|Other|laboratory biomarker analysis|
11998904|NCT00601588|Drug|Sertraline|
11998905|NCT00601575|Drug|Lithium|
11998906|NCT00601562|Drug|Zidovudine|
11998907|NCT00601549|Procedure|Laparoscopic surgery|Laparoscopic surgery
11998908|NCT00601549|Procedure|Traditional open surgery|Open surgery
11998909|NCT00601536|Drug|Lithium|
11998910|NCT00601523|Drug|Placebo|Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
11998911|NCT00601523|Drug|Pramipexole|ER 0.375-4,5 mg
11998912|NCT00601510|Drug|capecitabine|
11998913|NCT00601510|Drug|cisplatin|
11998914|NCT00601510|Drug|imatinib mesylate|
11998915|NCT00601497|Device|InterX 5000|20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks.
11998916|NCT00601484|Drug|PF-04383119|PF-04383119 200 mcg/kg IV, single dose
11998917|NCT00601484|Drug|Placebo|placebo IV, single dose
11998918|NCT00601471|Other|proximal tibiofibular manipulation|proximal tibiofibular manipulation
11998919|NCT00601471|Other|distal tibiofibular manipulation|distal tibiofibular manipulation
11998920|NCT00601471|Other|no intervention|no intervention / control
11998921|NCT00601458|Drug|pregabalin|Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
11998922|NCT00601458|Drug|naproxen sodium|Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0.
11998923|NCT00601458|Drug|Comparator: Placebo|Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
11998924|NCT00601445|Behavioral|Amount of sleep and wake|4 groups with different patterns of sleep and wake
11998925|NCT00601432|Drug|levofloxacin oral solution|
11998926|NCT00601419|Drug|Somatropin|"Genotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg.
~Dosage, Frequency: According to Japanese LPD, The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day.
~Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration."
11998927|NCT00601406|Genetic|gene expression analysis|
11998928|NCT00601406|Genetic|gene rearrangement analysis|
11998929|NCT00601406|Genetic|polymorphism analysis|
11998930|NCT00601406|Other|laboratory biomarker analysis|
11998931|NCT00601406|Radiation|radiation therapy|
11998932|NCT00601393|Behavioral|Cognitive behavioral therapy (CBT)|CBT treatment is delivered via the Internet. Adaptations to the CBT program will include the addition of content of particular relevance to mothers of young children and the incorporation of instructional design principles to promote self-learning. The treatment program will take advantage of the unique properties of the Internet, including multimedia presentations and interactive components with professional and moderated peer social support.
11998933|NCT00601393|Other|Treatment as usual (TAU)|Participants receiving TAU will be offered the CBT treatment after a wait-list period. During the wait-list period, participants will be offered facilitated referrals to treatment provided in the community.
11998934|NCT00601367|Drug|flibanserin flexible dose|"Initial dosage:
~Patients were to take one 50 mg flibanserin tablet in the evening.
~Subsequent dosage titrations:
~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.
~Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.
~Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
11998935|NCT00601354|Behavioral|Emotion regulation group therapy|Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy.
11998936|NCT00601354|Drug|Orlistat/alli program|The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with online access.
11998937|NCT00601341|Other|lumbosacral joint manipulation|lumbosacral joint manipulation
11998938|NCT00601341|Other|lumbar passive range of motion|lumbar passive range of motion
11998939|NCT00601341|Other|No active intervention|Lie on exam table for 3 minutes
11998940|NCT00601328|Drug|Calcitriol|
11998941|NCT00601315|Drug|Clarithromycin|
11998942|NCT00601302|Drug|Amlodipine|
11998943|NCT00601289|Drug|temozolomide|
11998944|NCT00601289|Genetic|DNA methylation analysis|
11998945|NCT00601289|Genetic|microarray analysis|
11998946|NCT00601289|Genetic|protein expression analysis|
11998947|NCT00601289|Genetic|proteomic profiling|
11998948|NCT00601289|Other|laboratory biomarker analysis|
11998949|NCT00601276|Drug|leuprorelin|Subcutaneous injection, 3.75 mg every 4 weeks
11998950|NCT00601276|Drug|Cyproterone acetate|2.0 mg/kg/day, tablet, per os
11998951|NCT00601263|Drug|Anti-Asthma Herbal Medical Intervention (ASHMI)|We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.
11998952|NCT00601250|Drug|linagliptin|Patients receive linagliptin 5 mg tablets once daily
11998953|NCT00601250|Drug|linagliptin|Patients receive linagliptin 5 mg tablets once daily
11998954|NCT00601237|Behavioral|HIV-related text messaging|Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
11998955|NCT00601237|Behavioral|Nutrition-related text messaging|Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
11998956|NCT00601224|Behavioral|Social cognition and interaction training (SCIT)|SCIT is a group-based treatment that has the goal of improving social cognition and social functioning for individuals with psychotic disorders. SCIT is composed of three phases: emotion training, figuring out situations, and integration. SCIT will be delivered by two therapists in 20 weekly sessions over 5 months.
11998957|NCT00601224|Behavioral|Treatment as usual (TAU)|TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.
11998958|NCT00601211|Drug|Pilocarpine|
11998959|NCT00601198|Drug|Amifostine|Patients should be treated with oxaliplatin-based chemotherapy in combination with amifostine for 12 cycles, or until unacceptable toxicity is observed or disease progression
11998960|NCT00601185|Procedure|confocal microscopy in vivo|A dermatologist will perform a shave biopsy according to standard clinical procedures. This study will be carried out after the shave biopsy. The deep surface and the peripheral margins will be imaged on each patient.
11998961|NCT00601172|Drug|Casopitant|Experimental NK-1 receptor antagonist
11998962|NCT00601172|Drug|Dexamethasone|Standard antiemetics
11998963|NCT00601172|Drug|Placebo|Placebo to match IV casopitant
11998964|NCT00601172|Drug|Ondansetron|Standard antiemetics
11998965|NCT00601159|Drug|gemcitabine and cisplatin|Cispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks
11998966|NCT00601146|Procedure|chest computed tomography scan|Once a year for three years
11998967|NCT00601133|Other|Walking Test|"Timed Test 1: From sitting position walk 10 feet quickly, return to sitting position Timed Test 2: Walk 25 feet, turn around, and walk back
~Tests conducted twice, once on departure from rehabilitation center, and again at a return visit 1 month later"
11998968|NCT00601133|Other|Balance Test|Machine balance test: Stand on a platform with a rail, shift weight and try to maintain balance and center of gravity; Results displayed.
11998969|NCT00601133|Behavioral|Questionnaire|To be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes.
11998970|NCT00601133|Behavioral|Diary|Record any physical exercise done from departure of rehabilitation center to return visit 1 month later; includes exercises; approximately 5 minutes per entry
11998971|NCT00601120|Procedure|Radiofrequency Ablation|Needles are inserted into the tumor(s) under guidance by a CT scan or ultrasound. The electrodes in the needles will be heated up to 202 degrees Fahrenheit and will remain heated for up to 12 minutes.
11998972|NCT00601107|Drug|Doxercalciferol|
11998973|NCT00601107|Drug|Placebo|
11998974|NCT00601094|Biological|autologous dendritic cell-adenovirus CCL21 vaccine|Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.
11998975|NCT00601068|Other|Observational|Group of patients with osteochemonecrosis related to oral bisphosphonate use
11998976|NCT00601055|Behavioral|Problem Solving-Rx Adherence (PSA)|In PSA, a therapist teaches the participant to identify problems related to depression, functioning, and treatment adherence; to generate multiple solutions; and to choose and implement one or more of those solutions.
11998977|NCT00601055|Behavioral|PID-C|In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.
11998978|NCT00601042|Other|Swedish snus (smokeless tobacco)|Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
11998979|NCT00601042|Other|Onico|Tobacco-free, nicotine-free placebo snus, 2 sachet sizes (1.0 g, 0.5 g), 2 flavors (same as in the experimental arm). Usage ad libitum.
11998980|NCT00601016|Drug|Imiquimod 5% cream|Imiquimod 5% cream applied topical on hemangioma once a day , 3 to 7 times a week for a maximum of 4 months.
11998981|NCT00601003|Drug|Nifurtimox|30mg/kg/day PO divided into TID dosing q day
11998982|NCT00601003|Drug|Cyclophosphamide|250 mg/m2/dose in normal saline, IV, infused over 30 minutes on days 1-5 of each cycle.
11998983|NCT00601003|Drug|Topotecan|0.75mg/m2/dose, in normal saline, IV, infused over 30 minutes on days 1-5 of each cycle.
11998984|NCT00600990|Drug|GW597599|
11998985|NCT00600977|Drug|Doxorubicine|9mg/m² J1 J4 2 COURSES
11998986|NCT00600977|Drug|Doxorubicine pegylated|40 MG/M² J1 2 courses
11998987|NCT00600964|Drug|GX15-070MS|A 60-minute or 3-hour IV infusion every 2-3 weeks.
11998988|NCT00600964|Drug|GX15-070MS|GX15-070MS at various doses and schedules
11998989|NCT00600938|Drug|Core Study: Deferasirox|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
11998990|NCT00600938|Drug|Core Study: Deferoxamine|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
11998991|NCT00600938|Drug|Extension: deferoxamine to deferasirox|40 mg/kg deferasirox once daily administered 30 minutes before taking food.
11998992|NCT00600938|Drug|Extension: deferasirox to deferoxamine|DFO at a target range of 50 mg/kg/day to 60 mg/kg/day via subcutaneous (sc) infusion lasting a period of 8 to 12 hrs administered for 5 to 7 days per week,
11998993|NCT00600938|Drug|Deferasirox|
11998994|NCT00600938|Drug|Deferoxamine|
11998995|NCT00600925|Drug|gentamicin-collagen sponge dipped in saline|2 gentamicin-collagen sponges inserted before closure of the laparotomy
11998996|NCT00600912|Drug|SMOFlipid®|continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.
11998997|NCT00600912|Drug|2-ClinOleic 20%®|continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.
11998998|NCT00600899|Procedure|elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h|Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 500 ml reservoir and infusion rate of 8 ml/h)
11998999|NCT00600899|Procedure|elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h|Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 275 ml reservoir and infusion rate of 5ml/h)
11999000|NCT00600886|Drug|Pasireotide|Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.
11999001|NCT00600886|Drug|Octreotide|Octreotide LAR - i.m. depot injection given once every 28 days.
11999002|NCT00600873|Drug|R(+) pramipexole dihydrochloride monohydrate|100 mg tid orally daily
11999003|NCT00600860|Other|No interventions|Only registration of clinical practice
11999004|NCT00600847|Drug|desloratadine|single dose for 7 days, oral, 20mg
11999005|NCT00600847|Drug|desloratadine|single dose for 7 days, oral, 5 mg
11999006|NCT00600847|Drug|placebo|single dose for 7 days, oral
11999007|NCT00600821|Drug|Bevacizumab|Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.
11999008|NCT00600821|Drug|Carboplatin|Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.
11999009|NCT00600821|Drug|Paclitaxel|Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
11999010|NCT00600821|Drug|AG-013736 (axitinib)|AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-
11999011|NCT00600821|Drug|Carboplatin|Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.
11999012|NCT00600821|Drug|Paclitaxel|Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
11999013|NCT00600808|Drug|BPLG-003|
11999014|NCT00600795|Other|CSF collection|CSF collection at time of VPS insertion
11999015|NCT00600782|Biological|GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)|Intramuscular injection, 2 doses at 0, 1 month
11999016|NCT00600769|Drug|Clarithromycin|Dosage dependent on clinical factors such as age, weight and patient-specific health status
11999017|NCT00600756|Drug|Quetiapine XR|Oral, once daily, tablets of 400 mg to 800 mg
11999018|NCT00600756|Drug|Risperidone|Oral, once daily, tablets of 2 mg to 6 mg
11999019|NCT00600743|Drug|GSKI181771X (CCK-1R agonist)|Drug one trial vs placebo
11999020|NCT00600743|Behavioral|Instructions to binge eat|Subjects will be instructed to binge eat and will also be given either drug or placebo
11999021|NCT00600743|Behavioral|Instructions to eat normally|Subjects will be instructed to eat normally and will also be given either drug or placebo
11999022|NCT00600743|Drug|Placebo|Drug one trial vs placebo
11999023|NCT00600730|Procedure|Hyperinsulinemic euglycemic clamp with fMRi|Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi
11999024|NCT00600730|Procedure|Hyperinsulinemic hypoglycemic clamp study with fMRi|Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning
11999025|NCT00600704|Procedure|Fluid Restriction Policy|Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass
11999026|NCT00600704|Procedure|Free fluid infusion|Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass
11999027|NCT00600691|Drug|Finasteride|one tablet (5mg) of finasteride
11999028|NCT00600678|Dietary Supplement|ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)|Single, oral administration of nutritional supplement under fasting condition within 2 minutes.
11999029|NCT00600665|Behavioral|PAINReportIt|A pain assessment data collection tool
11999030|NCT00600665|Behavioral|PAINUCope|A multimedia patient education program tailored to the participant's SCD pain management misconceptions
11999031|NCT00600665|Behavioral|PAINConsultN|A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
11999032|NCT00600639|Device|Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option|A mode of ventilation that does not require the insertion of the endotracheal tube, since the support is delivered throgh a full face or nasal mask
11999033|NCT00600639|Drug|standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed|Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed
11999034|NCT00600639|Drug|standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed|oxygen plus medical therapy for ARF
11999035|NCT00600626|Drug|biphasic insulin aspart|
11999036|NCT00600626|Drug|insulin NPH|
11999037|NCT00600626|Drug|insulin aspart|
11999038|NCT00600613|Radiation|cone beam imaging|All study patients will undergo simulation, treatment planning and verification as currently practiced. The contrast injection and cone beam imaging will be added to the standard procedure just prior to treatment delivery on the first and last days of treatment only.
11999039|NCT00600600|Drug|Tigecycline|Tigecycline dosage based on age and clinical status of patient.
11999040|NCT00600587|Drug|neoadjuvant erlotinib therapy|150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.
11999041|NCT00600587|Drug|neoadjuvant gemcitabine/carboplatin therapy|3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.
11999042|NCT00600574|Other|physical therapy|weekly pool physiotherapy with muscle stretching
11999043|NCT00600574|Other|physical therapy|weekly pool physiotherapy with Ai Chi movements during a 6 months period
11999044|NCT00600561|Behavioral|MBSR|Mindfulness-Based Stress Reduction Intervention
11999045|NCT00600548|Drug|Miltefosine.|Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
11999046|NCT00600548|Drug|Meglumine antimoniate.|Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
11999047|NCT00600548|Drug|Miltefosine.|Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
11999048|NCT00600548|Drug|Meglumine antimoniate.|Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
11999049|NCT00600535|Drug|Stage 1 Group 1: abiraterone acetate|1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.
11999050|NCT00600535|Drug|Stage 1 Group 2: abiraterone acetate|1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.
11999051|NCT00600535|Drug|Stage 2: abiraterone acetate|1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
11999052|NCT00600535|Drug|Stage 3: abiraterone acetate|1000 mg tablets/day orally for 12 cycles (28 days/cycle).
11999053|NCT00600535|Drug|Stage 3: glucocorticoid|prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).
11999054|NCT00600535|Drug|Stage 4: abiraterone acetate|1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).
11999055|NCT00600535|Drug|Stage 4: glucocorticoid|prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).
11999056|NCT00600522|Procedure|Ultrasound-guided hepatectomy|"After laparotomy and staging by intraoperative ultrasound (IOUS), anterior surface of the hepatocaval confluence is exposed. Than, compression by means of the surgeon's finger-tip is applied at the MHV caval confluence verifying at color-Doppler IOUS the disappearance of the blood flow in the MHV or its inversion. Then, MHV clamping itself is carried out, and parenchymal sparing resection would be selected if at least one of these 3 findings is confirmed:
~Reversal color-Doppler IOUS flow direction in the peripheral portion of the MHV, which suggests the drainage through collateral circulation in the RHV/LHV depending on the side of the MHV branch with reversal flow.
~Detectable shunting collaterals at color-Doppler IOUS with RHV or LHV.
~Hepatopetal flow in P5-8 and/or P4inf portal branches. If none of these finding is confirmed and in particular hepatofugal flow direction in the P5-8 and/or P4 inf is detected the hepatectomy has to be extended."
11999057|NCT00600509|Drug|Levetiracetam|
11999058|NCT00600496|Drug|AZD6244|twice daily oral dose
11999059|NCT00600496|Drug|Dacarbazine|intravenous infusion
11999060|NCT00600496|Drug|Erlotinib|daily oral dose
11999061|NCT00600496|Drug|Docetaxel|intravenous infusion
11999062|NCT00600496|Drug|Temsirolimus|intravenous infusion
11999063|NCT00600483|Drug|gentamicin-collagen sponge dipped in saline|100-cm2 sponge
11999064|NCT00600470|Behavioral|Doctor-office collaborative care (DOCC) management|DOCC is an evidence-based psychosocial treatment approach that incorporates (1) adaptation of an evidence-based collaborative care approach using the chronic care model and participatory management theory to enhance training, implementation, and sustainability; (2) revised protocol content that includes medication management for ADHD, brief anxiety management, and attention to parental/partner dysfunction; (3) technological developments to facilitate screening/assessment, monitoring, and communication; and (4) an improved methodology that includes new samples, measures, and settings.
11999065|NCT00600470|Behavioral|Treatment as usual (TAU)|TAU involves routine care: psychoeducation and referral to outside providers.
11999066|NCT00600457|Device|Polyurethane Film|The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day
11999067|NCT00600444|Procedure|Venae sectio|surgical preparation of the cephalic vene to insert a totally implantable access port.
11999068|NCT00600444|Procedure|Punction of V. subclavia|radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
11999069|NCT00600405|Drug|tamsulosin|Tamsulosin 0.4 mg orally daily for ten days.
11999070|NCT00600405|Drug|Standard therapy with ibuprofen and oxycodone.|Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.
11999071|NCT00600379|Device|Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).|Training 2/w for 9 weeks (total 18 sessions).
11999072|NCT00600366|Drug|biphasic insulin aspart|
11999073|NCT00600353|Drug|Palonosetron|Palonosetron 0.25 mg IV over 30 seconds
11999074|NCT00600353|Drug|Aprepitant|Aprepitant 125 mg PO and Aprepitant 80 mg PO
11999075|NCT00600353|Drug|Dexamethasone|Dexamethasone 4 mg IV and Dexamethasone 4 mg IV push
11999076|NCT00600340|Biological|Bevacizumab and Paclitaxel|A: Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
11999077|NCT00600340|Biological|Bevacizumab and Capecitabine|B:Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks
11999078|NCT00600327|Device|EndoTex™ NexStent™|EndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.
11999079|NCT00600327|Device|Filter Wire EZ™|EPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
11999080|NCT00600301|Drug|Triamcinolone Acetonide and Bevacizumab|
11999081|NCT00600288|Drug|diquafosol tetrasodium Ophthalmic Solution, 2%|1-2 drops administered in each eye 4 times a day for 6 weeks
11999082|NCT00600288|Drug|Non-preserved saline solution (Placebo)|1-2 drops administered in each eye 4 times a day for 6 weeks
11999083|NCT00600275|Drug|BGT226|
11999084|NCT00600262|Drug|intravitreal bevacizumab|
11999085|NCT00600249|Drug|Cetuximab|dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks
11999086|NCT00600249|Drug|Docetaxel|100mg/m2 every 21 days 6 cycles of 21 days
11999087|NCT00600236|Procedure|blood sample|
11999088|NCT00600223|Behavioral|questionnaires and standardized, digital voice recording|Patient will be asked to complete four sets of forms. Upon completion of these forms, the study subject and the investigator will proceed to a quiet room for the standardized, digital voice recording. Recording will be made on digital audiotape using a standardized portable, digital audio recorder.
11999089|NCT00600210|Drug|Bevacizumab|Bevacizumab will be delivered intravenously on day -7 at a dose of 10 mg/kg followed by carboplatin AUC 2.0 intravenously. This will allow therapy to start one week before starting radiotherapy to assess the initial tolerability of the combination without having radiation as a confounding factor, to start treatment while the patient's radiation is being planned, and to possibly optimize the tumor vasculature and allow optimal carboplatin delivery by the time chemoradiotherapy starts. Thereafter, bevacizumab will be given intravenously at 10 mg/kg every two weeks. Carboplatin will be given intravenously weekly at AUC 2.0. On weeks where both drugs are given, bevacizumab will be given first since it could help sensitize the tumor cells to carboplatin.
11999090|NCT00600210|Drug|Carboplatin|Bevacizumab will be delivered intravenously on day -7 at a dose of 10 mg/kg followed by carboplatin AUC 2.0 intravenously. This will allow therapy to start one week before starting radiotherapy to assess the initial tolerability of the combination without having radiation as a confounding factor, to start treatment while the patient's radiation is being planned, and to possibly optimize the tumor vasculature and allow optimal carboplatin delivery by the time chemoradiotherapy starts. Thereafter, bevacizumab will be given intravenously at 10 mg/kg every two weeks. Carboplatin will be given intravenously weekly at AUC 2.0. On weeks where both drugs are given, bevacizumab will be given first since it could help sensitize the tumor cells to carboplatin.
11999091|NCT00600210|Radiation|Radiation Therapy|"Whole pelvis will be treated to a total dose of 45 Gy in 5 weeks.
~Cesium will be used with standard intracavitary systems preferably in two intracavitary applications. An effort should be made to deliver a minimum cumulative external and intracavitary dose to Point A of 85 Gy in 2 insertions."
11999092|NCT00600197|Behavioral|back school|A kind of educational program for low back pain
11999093|NCT00600171|Drug|GW642444M|GW642444M
11999094|NCT00600171|Drug|Placebo|Placebo mulit-dose dry powder inhaler
11999095|NCT00600158|Drug|bupivacaine with hydromorphone|bupivacaine 0.125% with hydromorphone 6 mcg/ml epidurally at 10 ml/h
11999096|NCT00600158|Drug|lidocaine|lidocaine 2 mg/min intravenously (or 3 mg/kg in patients > 70 kg)
11999097|NCT00600145|Drug|Mirtazapine|15 mg Mirtazapine is administered followed 2 hours later by 20 mg of methamphetamine / placebo (administered at each testing visit)
11999098|NCT00600145|Other|Placebo|Placebo
11999099|NCT00600119|Drug|placebo|placebo, oral, once daily (QD)
11999100|NCT00600119|Drug|NKTR-118|5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
11999101|NCT00600106|Drug|1/10 NA/EE|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)
11999102|NCT00600106|Drug|Placebo|1 mg placebo
11999103|NCT00600093|Drug|Amantadine|IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery
11999104|NCT00600080|Device|etafilcon A|contact lens worn daily for one week (first or second week depending on arm)
11999105|NCT00600080|Device|nelfilcon A|Contact lens worn daily for one week (first or second week depending on arm)
11999106|NCT00600067|Drug|Phentermine/Topiramate|phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
11999107|NCT00600067|Drug|Placebo|Oral placebo capsules, once daily, 28 weeks
11999108|NCT00600054|Biological|nimotuzumab (anti EGFR humanized monoclonal antibody)|150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity.
11999109|NCT00600041|Drug|Pantoprazole|80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes
11999110|NCT00600041|Drug|Placebo|Identical infusion manner like experimental arm
11999111|NCT00600028|Drug|Thalidomide|Thalidomide 50 - 100 mg by mouth daily
11999112|NCT00600028|Drug|Placebo|Placebo 50-100 mg by mouth per day
11999113|NCT00600015|Drug|Erlotinib + Sorafenib|Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day.
11999114|NCT00600015|Drug|Erlotinib + Placebo|Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.
11999115|NCT00600002|Biological|GM-CSF|Cohort 1: 50 ug/m2 given Intravenous. Cohort 2: 150 ug/m2 given Intravenous. Cohort 3: 250 ug/m2 given Intravenous. Cohort 4: 0 ug/m2 and vehicle (normal saline) given Intra-tumoral. Cohort 5: 50 ug/m2 given Intra-tumoral. Cohort 6: 150 ug/m2 given Intra-tumoral. Cohort 7: 250 ug/m2 given Intra-tumoral.
11999116|NCT00599989|Procedure|adjuvant therapy|
11999117|NCT00599989|Procedure|conventional surgery|
11999118|NCT00599989|Radiation|3-dimensional conformal radiation therapy|
11999119|NCT00599989|Radiation|brachytherapy|
11999120|NCT00599989|Radiation|intracavitary balloon brachytherapy|
11999121|NCT00599989|Radiation|proton beam radiation therapy|
11999122|NCT00599976|Procedure|Pulmonary vein isolation|Pulmonary vein isolation
11999123|NCT00599963|Drug|paricalcitol|paricalcitol 1 mg/day
11999124|NCT00599950|Drug|Mitomycin C and Photorefractive keratectomy (PRK)|Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
11999125|NCT00599937|Drug|ATRA|early introduction of ATRA
11999126|NCT00599937|Drug|ATRA and or Chemo as maintenance|patients were randomized both to receive or not receive intermittent ATRA (45 mg/m2/d, 15 days every 3 months) and to receive or not receive continuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, orally), according to a 2-by-2 factorial design stratified on the initial induction treatment group
11999127|NCT00599924|Drug|sunitinib + FOLFOX|37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
11999128|NCT00599924|Drug|sunitinib + FOLFOX|50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
11999129|NCT00599924|Drug|sunitinib + FOLFOX|50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)
11999130|NCT00599924|Drug|sunitinib + FOLFOX|37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
11999131|NCT00599924|Drug|sunitinib + FOLFOX|50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
11999132|NCT00599924|Drug|sunitinib + FOLFOX|37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
11999133|NCT00599924|Drug|sunitinib + FOLFOX|25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
11999134|NCT00599911|Drug|Lu AA24530|per oral, once daily for 6 weeks
11999135|NCT00599911|Drug|Duloxetine|per oral, once daily for 6 weeks
11999136|NCT00599911|Drug|Placebo|per oral, once daily for 6 weeks
11999137|NCT00599898|Drug|Atosiban|Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
11999138|NCT00599898|Drug|Nifedipine|Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
11999139|NCT00599885|Drug|telmisartan|telmisartan 40-80mg once per day for 8 months
11999140|NCT00599885|Drug|valsartan|valsartan 80-160mg once per day for 8 months
11999141|NCT00599872|Biological|Standardized Ragweed Allergenic Extract|Standardized Ragweed Allergenic Extract, sublingual oral
11999142|NCT00599872|Biological|Placebo|Placebo, sublingual oral
11999143|NCT00599859|Dietary Supplement|lactose|consumption of 50g lactose/day in 2 divided doses mixed in water.
11999144|NCT00599859|Dietary Supplement|lactose|consumption of lactose 50g/day in 2 divided doses mixed in water
11999145|NCT00599833|Biological|cetuximab|
11999146|NCT00599833|Radiation|3-dimensional conformal radiation therapy|
11999147|NCT00599820|Drug|Intravitreal Bevacizumab|
11999148|NCT00599807|Dietary Supplement|Vitamin D3 (cholecalciferol)|the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU)
11999149|NCT00599781|Genetic|gene transduced PBL and/or gene transduced HSC|infusions of autologous PBL and/or HSC transduced with retroviral vectors encoding ADA
11999150|NCT00599768|Other|ID-Pain DN4 Questionnaire|This is a non-interventional questionnaire validation study
11999151|NCT00599755|Radiation|Comparator: CT or MRI and FDG-PET|Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle.
11999152|NCT00599755|Drug|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart.
11999153|NCT00599742|Behavioral|Balance training|Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
11999154|NCT00599742|Behavioral|Motor training|Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.
11999155|NCT00599716|Drug|sodium hyaluronate|a sterile, unpreserved eye drop containing sodium hyaluronate in a proprietary formulation to be administered by ocular instillation
11999156|NCT00599716|Drug|vehicle|identical to proprietary formulation of active eye drop but without active ingredient, sodium hyaluronate
11999157|NCT00599703|Other|fMRI Scan, pre- and post language evaluation|All subjects will undergo functional MR imaging, pre- and post-surgical language evaluation, and electrocortical stimulation mapping. The brain tumor patients will undergo these procedures twice.
11999207|NCT00599274|Drug|Interferon beta-1a|injection three times a week
11999294|NCT00598481|Drug|PEG-ADA|polyethylene glycol (PEG)-ADA is discontinued prior to gene therapy
11999158|NCT00599690|Procedure|Epi-LASK|10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes
11999159|NCT00599677|Other|acupuncture|Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
11999160|NCT00599677|Drug|Itopride|Each pill weighs 50mg, once a pill, three times a day. The pills are taken half an hour before meals, and be taken 4 weeks continuously.
11999161|NCT00599664|Drug|OMS201|OMS201 irrigation solution during surgery
11999162|NCT00599664|Drug|Vehicle|Vehicle irrigation solution during surgery
11999163|NCT00599651|Device|Surfactant administered via Laryngeal Mask Airway (LMA)|Standard volume of Infasurf surfactant (3 mL/kg) will be injected in 2-4 aliquots into the proximal end of the LMA.
11999164|NCT00599651|Other|standard of care (nasal CPAP and supplemental oxygen)|Standard of care will be utilized which may mean surfactant is administered
11999165|NCT00599638|Drug|pregabalin|75mg bid titrating to 150mg bid on day 4
11999166|NCT00599638|Drug|pregabalin/PF-00489791|Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
11999167|NCT00599638|Drug|Placebo|Placebo
11999168|NCT00599625|Drug|Pravastatin|80mg administered daily for 6 consecutive weeks
11999169|NCT00599612|Drug|GW856553|A dose of 10mg GW856553 containing 50µCi of [14C]GW856553 will be delivered as 100mL of a 0.1mg/mL GW856553/0.5 µCi/mL oral solution.
11999170|NCT00599599|Behavioral|Prolonged Exposure Therapy|Participants will meet with a therapist twice a week for 5 weeks to complete the therapy. If the therapist and participant feel more sessions are needed, an additional 8 sessions will be provided.
11999171|NCT00599586|Other|acupuncture|Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
11999172|NCT00599573|Drug|ondansetron|Ondansetron 4mg BID for six weeks
11999173|NCT00599560|Genetic|vasopressin, V2 receptor and cyclic AMP|plasma vasopressin, V2 receptor, cyclic AMP
11999174|NCT00599547|Procedure|Allogeneic Stem Cell Transplantation|Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
11999175|NCT00599534|Drug|Montelukast|4 mg oral tablets
11999176|NCT00599534|Drug|Placebo|5mg tablets
11999177|NCT00599521|Drug|Adapalene lotion 0.1%|Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
11999178|NCT00599521|Drug|Adapalene Lotion Vehicle|Vehicle will be applied topically to the face, once a day, for 12 weeks
11999179|NCT00599508|Dietary Supplement|Concord grape juice|Several ounces Concord grape juice administered 3 times a day for 12 or 16 weeks. Specific dosage determined by participant's weight.
11999180|NCT00599508|Dietary Supplement|placebo juice|several ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight
11999181|NCT00599508|Dietary Supplement|blueberry juice|wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight
11999182|NCT00599508|Dietary Supplement|whole fruit blueberry powder|whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks
11999183|NCT00599508|Dietary Supplement|berry placebo powder|berry placebo powder administered daily for 16 weeks
11999184|NCT00599495|Procedure|allogeneic HSCT|dose-reduced conditioning regimen
11999185|NCT00599482|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far infrared radiation for 30 to 40 minutes during each session.
11999186|NCT00599469|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared radiation for 30 to 40 minutes per treatment session.
11999187|NCT00599456|Dietary Supplement|Omega 3 fatty acid vitamins|Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months
11999188|NCT00599456|Dietary Supplement|Placebo capsules|Placebo capsules,2 capsules, by mouth, daily for 3 months
11999189|NCT00599443|Biological|Seasonal cell-derived influenza vaccine|0.5 mL im, single dose
11999190|NCT00599443|Biological|Placebo Comparator|0.5 mL im, single dose
11999191|NCT00599430|Dietary Supplement|Placebo|Inert excipient
11999192|NCT00599430|Dietary Supplement|Lactobacillus acidophilus NCFM|1e10 CFU/day
11999193|NCT00599430|Dietary Supplement|Combination of Lactobacillus acidophilus and Bifidobacterium lactis|1x10e10 CFU/day
11999194|NCT00599417|Drug|Bacterial Lysates|Bacterial Lysates ampoules 3 mL, oral route, daily for 10 days, followed by 30 days free of medication and then 10 days of administration of the drug
11999195|NCT00599417|Drug|placebo|placebo controlled
11999196|NCT00599404|Drug|PN400|500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
11999197|NCT00599391|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation for 30 to 40 minutes per session.
11999198|NCT00599378|Behavioral|Implementation Intentions-based telephone counseling|Implementation Intentions-based telephone counseling
11999199|NCT00599365|Other|Pharmacy care arm|"The pharmacist will take all your medication bottles, and give you medication boxes filled with your medications in the order you should take them in.
~You will need to give a complete list of medications to the pharmacist.
~You will need to describe how you take these medications.
~The pharmacist will teach you about the medications. This includes side effects, drug interactions, and directions.
~The pharmacist will give you a medication schedule, and other papers about your medications."
11999200|NCT00599352|Dietary Supplement|magnesium|Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)
11999201|NCT00599326|Drug|Deferasirox|250 mg of deferasirox once daily for 6 months
11999202|NCT00599313|Drug|Sunitinib|50 mg/day orally each of Days 1-28 of each 6 week cycle
11999203|NCT00599287|Drug|Haloperidol|Haloperidol 2,5 mg. 2 dd 1, oral. (if patient is 69 years or younger) Haloperidol 1 mg. 2 dd 1, oral (if patient is 70 years or older)
11999204|NCT00599287|Drug|Methylphenidate|Methylphenidate 5 mg. 2 dd 1, oral, increased every day with 10 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 30 mg./day
11999205|NCT00599287|Drug|Rivastigmine|Rivastigmine 1,5 mg. 2 dd 1, oral, increased every third day with 3 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 12 mg./day
11999206|NCT00599274|Drug|Interferon beta-1a|injection once a week
11999208|NCT00599261|Procedure|ICD/pacemaker pocket revision|Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads
11999209|NCT00599248|Biological|TissueGene-C|TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
11999210|NCT00599248|Biological|Placebo|Placebo control (DMEM)
11999211|NCT00599235|Drug|sildenafil|50mg 3 times daily for 7 days
11999212|NCT00599235|Drug|hydralazine|25mg 3 times daily for 7 days
11999213|NCT00599235|Drug|placebo|3 times daily for 7 days
11999214|NCT00599222|Biological|ranibizumab|0.5 mg intravitreal injection
11999215|NCT00599222|Procedure|TTT|Transpupillary thermotherapy (TTT)
11999216|NCT00599222|Procedure|Sham TTT|Sham Transpupillary thermotherapy (TTT)
11999217|NCT00599209|Other|clinical decision support|CDS is provided to prescribers on intervention units upon ordering medication which offers advice on prescribing and monitoring practices
11999218|NCT00599196|Drug|Rotigotine|"Rotigotine trans-dermal patches, once daily:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
~Optimal dosing:
~During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.
~After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours."
11999219|NCT00599183|Other|MRI-Diffusion Tensor Imaging and Tractrography|MRI scan: Baseline: Conventional MRI (as part of clinical care) with additional diffusion tensor imaging (DTI)sequence (research). 6-week follow up: MRI with DTI and tractography as part of the research
11999220|NCT00599170|Drug|Rituximab|375 mg/m2 IV
11999221|NCT00599144|Procedure|videolaparocholecystectomy|Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
11999222|NCT00599144|Procedure|videolaparocholecystectomy|Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
11999223|NCT00599144|Procedure|videolaparocholecystectomy|Group3: control group without any local anesthetic use.
11999224|NCT00599131|Drug|Cisplatin|1. Day 1: 100 mg/m2, administered as an i.v. infusion will run over one hour. 2. Day #23: Subjects with a < 50% response (NR) to induction chemotherapy will undergo salvage laryngectomy followed by RT. Cisplatin will be added to radiation for patients whose surgical pathology reveals high-risk features (i.e. extracapsular spread, > 2 positive lymph nodes, perineural invasion, or positive margins). Cisplatin will either be dosed a 100 mg/m2 every 21 days or 40 mg/m2 weekly at the discretion of the prescribing physician.
11999225|NCT00599131|Drug|Cetuximab|1. Cetuximab will be administered at 400 mg/m2 on Day 20 (2 hour administration). 2. Cetuximab will be administered in combination with radiation therapy to those subjects who had a Partial or Complete response after the first cycle of the chemotherapy regimen is administered. The dosage for these administrations is 250 mg/m2 over sixty minutes and it will be administered for six weeks.
11999226|NCT00599131|Drug|5-Fluorouracil|5-FU will be administered 750 mg/m2 in 0.9% normal saline as a 24-hour continuous infusion, days #1-4.
11999227|NCT00599131|Drug|Docetaxel|75 mg/m2 by I.V. over one hour on Day # 1 only
11999228|NCT00599105|Procedure|magnetic resonance imaging|MRI contrast agent, 0.1 mmol/kg
11999229|NCT00599079|Drug|Azithromycin|Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors
11999230|NCT00599066|Device|study cases|Application of a second M-Entropy probe on the forehead of the patient, which will happen in the OR along with the application of other monitors immediately before induction of general anesthesia.
11999231|NCT00599053|Drug|Azithromycin|10 mg/kg IV per dose given for 10 days
11999232|NCT00599040|Behavioral|The DASH diet with weight loss|A reduced calorie diet is provided to participants based on the DASH diet.
11999233|NCT00599040|Behavioral|The DASH diet without weight loss|participants are given a weight maintainenance diet based on the DASH diet
11999234|NCT00599040|Behavioral|Dairy diet|participants are given a high dairy, reduced calorie diet
11999235|NCT00599027|Drug|Mometasone furoate nasal spray (MFNS)|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
11999236|NCT00599027|Drug|Placebo nasal spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
11999237|NCT00599001|Drug|SD-101|Single subcutaneous escalating dose
11999238|NCT00599001|Drug|placebo|placebo
11999239|NCT00598988|Procedure|traditional Chinese acupuncture|10 treatments over 6 weeks
11999240|NCT00598988|Other|standard medical care|standard care as provided by primary physician
11999241|NCT00598975|Drug|NKTR-102 + Cetuximab|Drug: NKTR-102 + Cetuximab
11999242|NCT00598962|Drug|Azithromycin|Dosage dependent on clinical factors such as age, weight and patient-specific health status
11999243|NCT00598962|Drug|Rifabutin/rifampin|
11999244|NCT00598936|Device|CDI 1000 COM and INVOS 5100|CDI 1000 and INVOS 5100 sensors were attached to subject's forehead for a 12 hour period, digital photographs were taken before and after sensor placement.
11999245|NCT00598923|Drug|topiramate|100 mg twice per day for 3 months
11999246|NCT00598923|Drug|topiramate|100 twice per day for 6 days after loading dose of phenytoin
11999247|NCT00598923|Drug|phenytoin|loading dose of 20 mg/kg and then 300 mg/day for total of 7 days
11999248|NCT00598910|Drug|Omacor|n-3 PUFA
11999249|NCT00598910|Drug|Placebo|Placebo
11999250|NCT00598897|Drug|clarithromycin, rifabutin|Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.
11999251|NCT00598884|Behavioral|Internet-Based Self-Management for Prolonged Grief Symptoms|The treatment consists of empirically derived cognitive behavioral therapy strategies to promote stable and active routines, self-care, accommodation of loss, enhanced self-efficacy, re-engagement in pleasurable activities, and reattachment with significant others. Treatment sessions will be Internet-based and will occur three times per week for 6 weeks.
11999252|NCT00598871|Drug|Thymosin Beta 4 (Tβ4)|There are 2 groups: active drug and placebo. The patients in the active arm receive an administration of 0.01% Tβ4 (w/w) eyedrops to the affected eye, 2 drops 4 times daily (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
11999621|NCT00595556|Drug|zonisamide|flexible dosages of 100-500mg/day
11999253|NCT00598871|Other|Placebo|There are 2 groups: active drug and placebo. The patients in the placebo arm receive an administration of 0.00% Tβ4(w/w) eyedrops to the affected eye, 2 drops four times a day (QID) (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
11999254|NCT00598858|Drug|Docetaxel|Given IV
11999255|NCT00598858|Drug|Prednisone|Given PO
11999256|NCT00598845|Procedure|Tumor biopsy study|Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.
11999257|NCT00598832|Drug|Adapalene lotion 0.1%|Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
11999258|NCT00598832|Drug|Adapalene Lotion Vehicle|Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
11999259|NCT00598819|Device|CDI 1000 COM|CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
11999260|NCT00598806|Drug|Apaziquone|A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
11999261|NCT00598806|Drug|Placebo|A single intravesical dose of placebo instilled into the bladder post-TURBT
11999262|NCT00598806|Procedure|TURBT|TransUrethral Resection of the Bladder Tumor
11999263|NCT00598793|Drug|biphasic insulin aspart|
11999264|NCT00598793|Drug|insulin glargine|
11999265|NCT00598793|Drug|metformin|
11999266|NCT00598793|Drug|pioglitazone|
11999267|NCT00598741|Other|DCE-MRI|"Patients will undergo DCE-MRI prior to, and within 18-24 days of starting chemotherapy. These studies are designed to determine if the DCE-MRI data will provide an a priori or early prognostic marker of tumor response. The dynamic MRI is done on a standard clinical scanner using standard techniques described below.
~MR imaging studies will be acquired on a 1.5T GE (Milwaukee,WI) Signa LX scanner."
11999268|NCT00598728|Behavioral|Quality of Life Questionaires|A patient questionnaire, which includes questions on medical morbidities and QOL, will be mailed to participants.
11999269|NCT00598715|Device|Sirolimus eluting stent|Sirolimus-eluting stent will be implanted
11999270|NCT00598715|Device|Paclitaxel-eluting stent|Paclitaxel-eluting stent will be implanted
11999271|NCT00598702|Drug|IV Acetaminophen|Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose
11999272|NCT00598689|Drug|0.3% hypromellose|0.3% hypromellose four times a day for 5 days prior to LASIK surgery
11999273|NCT00598676|Device|biodegradable polymer Rapamycin-eluting stent|due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
11999274|NCT00598676|Device|permanent polymer rapamycin-eluting stent (Cypher)|due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
11999275|NCT00598676|Device|permanent polymer everolimus-eluting stent (Xience, Promus)|due to randomization, everolimus-eluting stent with permanent polymer will be implanted
11999276|NCT00598663|Device|insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)|6 months of pump plus continuous glucose sensing in conjunction to SMBG
11999277|NCT00598663|Device|insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)|insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.
11999278|NCT00598650|Drug|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
11999279|NCT00598637|Device|Everolimus-eluting stent (Xience)|stent is implanted due to randomization
11999280|NCT00598637|Device|Zotarolimus-eluting stent (Endeavor Resolute)|stent is implanted due to randomization
11999281|NCT00598624|Drug|Treosulfan IV|Treosulfan i.v.: 14 g/m²/d from day -6 to day -4
11999282|NCT00598611|Drug|desloratadine|singel dose, oral, 20 mg
11999283|NCT00598611|Drug|desloratadine|single dose, oral, 5 mg
11999284|NCT00598585|Drug|Sildenafil (Viagra)|25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation.
11999285|NCT00598585|Drug|Placebo|Placebo pills 3X/day for 6 weeks
11999286|NCT00598572|Drug|Deferoxamine Mesylate|Various dose-regimens ranging from 7 mg/kg to 125 mg/kg (with a maximum allowable total daily dose of 6000 mg at any of the tested dose tiers, regardless of patient's weight), administered daily by IV infusion for three consecutive days.
11999287|NCT00598559|Drug|IV Acetaminophen|Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.
11999288|NCT00598546|Behavioral|EORTC QLQ-C30, QLQ-STO22, and MSK-10|QLQ-C30 is the generic QOL tool for patients with cancer undergoing clinical trials.QLQ-STO22, containing 22 questions specific to gastric cancer, is currently the only standardized disease-specific questionnaire to measure the QOL of gastric cancer and must be used in conjunction with the QLQ-C30.MSK-10 consists of ten additional questions that were developed by surgeons on the GMT service to answer specific questions about outcomes related to proximal subtotal, distal subtotal, and total gastrectomies. These questions focus on eating capabilities, work status and major life changing events.
11999289|NCT00598533|Device|Rapamycin + Probucol-eluting stent (ISAR stent)|due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
11999290|NCT00598533|Device|polymer based Zotarolimus-eluting stent (Endeavor Resolute)|due to randomization, Zotarolimus-eluting stent with polymer will be implanted
11999291|NCT00598507|Drug|ZK-EPO|Participants were treated with 16 mg/m^2 of ZK-EPO (EpothiloneZK) (Sagopilone) administered as a single 3 hour intravenous infusion every 21 days. Prior to each treatment, participants were premedicated with either granisetron or ondansetron and additional anti-emetics if needed. Chemotherapy was continued until disease progression, withdrawal of consent, or for unacceptable treatment-associated toxicity.
11999292|NCT00598481|Genetic|Gene Therapy|Infusion of autologous CD34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
11999293|NCT00598481|Drug|Busulfan|Busulfan is used for non-myeloablative conditioning
11999295|NCT00598442|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
11999296|NCT00598442|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
11999297|NCT00598442|Drug|Darbepoetin alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
11999298|NCT00598429|Drug|Inhaled Prostaglandin E1|Delivery of one dose of either high dose PGE1 (300 ng/kg/min), low dose PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug) via nebulizer over a 72-hour period
11999299|NCT00598416|Behavioral|Family-Responsive Psychoeducation Program (PERF)|Group psychoeducation for HCV patients and their primary caregiver.
11999300|NCT00598403|Drug|cefditoren pivoxil|400 mg, oral, single dose during 3 days
11999301|NCT00598403|Drug|Ciprofloxacin|250 mg, oral, twice a day for 3 days
11999302|NCT00598390|Drug|[11C]MePPEP|
11999303|NCT00598377|Drug|Tetracosactin|1 microgram tetracosactin, intravenous injection, once for the test
11999304|NCT00598338|Drug|Prucalopride|4 mg o.d.
11999305|NCT00598338|Other|Placebo|o.d.
11999306|NCT00598325|Biological|3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)|1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
11999307|NCT00598312|Drug|Leuprolide Acetate for Injectable Suspension|Sustained release injectable microspheres, 22.5 mg, one injection every 84 days, 3-month product
11999308|NCT00598299|Procedure|venous puncture|venous puncture
11999309|NCT00598299|Other|obtain serum from perripheral blood or cord blood|obtain serum from perripheral blood or cord blood
11999310|NCT00598286|Drug|[18F]FMPEP-d2|
11999311|NCT00598273|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
11999312|NCT00598273|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
11999313|NCT00598273|Drug|Darbepoetin alfa|As prescribed, starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
11999314|NCT00598260|Procedure|induction of labor|study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.
11999315|NCT00598247|Drug|Paclitaxel Poliglumex|Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks.
11999316|NCT00598234|Drug|Celecoxib (Celebrex)|The study group received 400mg oral celecoxib about 1 hr prior to surgery, and 200mg every 12 hrs, along with PCA morphine, over the first five post-operative days. The control group received placebo, along with PCA morphine over the same postoperative period. All patients received Acetaminophen 500mg qid for pain control.
11999317|NCT00598208|Drug|corifollitropin alfa|On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
11999318|NCT00598208|Drug|Follitropin beta injection|Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.
11999319|NCT00598195|Drug|Ketamine|subject will then receive an intravenous bolus dose of ketamine 2 mg/kg as a rapid intravenous bolus, over less than two minutes just prior to CPB. In the non-CPB patients, ketamine will be administered just prior to the skin incision. All doses will be rounded to the nearest tenth of a milligram. Timed blood samples will be collected at standardized times after the completion of the ketamine infusion and samples will be obtained from an indwelling arterial line. Each blood sample for pharmacokinetic analysis will be 1 mL.
11999320|NCT00598169|Biological|rituximab|375mg/m2 on Day 1
11999321|NCT00598169|Drug|bortezomib|Part A: Velcade Day 1 and Day 8 of a 28-day cycle, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2 Part B: Velcade on Days 1 and 8 of a 21-day cycle.
11999322|NCT00598169|Drug|carboplatin|"Carboplatin will be dosed to an AUC=5, calculated using the Calvert formula (5 x [creatinine clearance + 25]; the maximum dose of carboplatin is 750 mg.
~Part A: AUC=5 (maximum 750 mg) IV administered on Day 9. Part B: AUC=5 (maximum 750 mg) IV administered on Day 2."
11999323|NCT00598169|Drug|dexamethasone|Part A: 20 mg IV on Days 8-10. Part B: 20 mg IV on Days 1-3 and on Day 8.
11999324|NCT00598169|Drug|etoposide|Part A: 100 mg/m2 IV Days 8-10. Part B: 100 mg/m2 IV daily on Days 1 to 3.
11999325|NCT00598169|Drug|ifosfamide|"Part A: 5000 mg/m2 mixed with an equal amount of Mesna as a 24 hour continuous IV infusion on Day 9.
~Part B: 5000 mg/m2 mixed with an equal dose of Mesna administered via continuous infusion for 24 hours beginning on Day 2."
11999326|NCT00598169|Genetic|polymerase chain reaction|Correlate EBV/HHV-8 viral load changes with lymphoma response. HIV and EBV/HHV-8 viral loads will be assessed on baseline, day 2, 4, and 8 of week 1 of Part A.
11999327|NCT00598169|Genetic|western blotting|Peripheral blood mononuclear cells will be collected at Day 1 prior to chemotherapy, Day 2, 4 and 8 (prior to chemotherapy) then weekly during Part A, just prior to each additional cycle of Part B and at treatment completion. Western blot using antibody specific for APOBEC3G and antibody against actin for internal control will be used to quantify APOBEC3G levels. Changes at will be compared with baseline using a paired t-test.
11999328|NCT00598156|Drug|erlotinib (Tarceva)|Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
11999329|NCT00598156|Drug|bevacizumab (Avastin)|Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
11999622|NCT00595556|Drug|Placebo|Placebo
11999330|NCT00598143|Behavioral|Vignette, questionnaires and Saliva Samples|The short vignette discusses the health implications of potential molecular markers of cancer risk assessment. The questionnaire asks several multiple-choice questions to assess the participant's interest in and understanding of molecular risk assessment. Patients are instructed to swish with 10cc of Scope mouthwash and to expectorate into a sterile 50cc conical tube.
11999331|NCT00598143|Behavioral|Urine Collection, Smoking cessation treatment|Single void urine specimens (approximately 50 ml) will be collected in pre-labeled specimen containers on a 3-monthly (±1 month) basis for 12 months. Standard evidence-based therapy for smoking cessation, including behavioral therapy and pharmacological therapy, is provided.
11999332|NCT00598130|Biological|Fleece|Fibrin Patch
11999333|NCT00598117|Behavioral|Questionnaires|"Newly diagnosed patients will be assessed at four points Time 1 (prior to treatment)
~Initial QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 2 (initial post-op)
~Follow up QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS Time 3 (6 months post op)
~Follow up QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 4 (1 year post op)
~Follow up QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS"
11999334|NCT00598104|Drug|QAX576|
11999335|NCT00598104|Drug|Placebo|
11999336|NCT00598091|Drug|gemcitabine|1000mg/m2, Days 1, 8, 15
11999337|NCT00598091|Drug|dasatinib|50mg, PO, QD
11999338|NCT00598091|Drug|gemcitabine|1000mg/m2, days 1, 8, 15
11999339|NCT00598091|Drug|dasatinib|50mg, PO, BID
11999340|NCT00598078|Drug|Sodium Oxybate|Dose 1
11999341|NCT00598078|Drug|Sodium Oxybate|Dose 2
11999342|NCT00598078|Other|Placebo|Dose 3
11999343|NCT00598065|Other|PET/CT|Synchronized PET/CT Imaging
11999344|NCT00598052|Drug|Escitalopram|10mg/day
11999345|NCT00598026|Other|Tele- follow-up|Remote transmission to the implantation centre every 3 months
11999346|NCT00598026|Other|Conventional follow-up|Visits at the implantation centre every 3 months
11999347|NCT00598013|Drug|Pioglitazone|The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.
11999348|NCT00598000|Behavioral|questionnaires|"QOL Measures- The following measures will be administered at Pre-Op, First Post-Op Visit 4, 8, 12 months Post-Op.
~Brief Pain Inventory and daily analgesic log- enrollment, patients will fill out the BPI preoperatively, postoperative days 2 to 4, initial, 4-month, 8-month and 12-month postoperative visits."
11999349|NCT00598000|Behavioral|questionnaires|"QOL Measures- The following measures will be administered at Pre-Op, First Post-Op Visit 4, 8, 12 months Post-Op.
~Brief Pain Inventory and daily analgesic log- enrollment, patients will fill out the BPI preoperatively, postoperative days 2 to 4, initial, 4-month, 8-month and 12-month postoperative visits."
11999350|NCT00597974|Procedure|Angioplasty|(non-experimental) Carotid artery angioplasty and/or stent-supported angioplasty
11999351|NCT00597974|Device|Stent|(non-experimental) Precise™ Nitinol Self-Expanding Stent (Cordis Endovascular, Johnson & Johnson), S.M.A.R.T.® Control™ Stent (Cordis Endovascular, Johnson & Johnson), Wallstent® (Boston Scientific Medi-Tech)
11999352|NCT00597974|Other|Neurological and neuropsychological evaluations|Clinical examinations consisting of a neurological and neuropsychological evaluation
11999353|NCT00597974|Procedure|Angiography|(non-experimental) Coronary angiography
11999354|NCT00597948|Behavioral|Healthy Lifestyles Curriculum|Three consecutive days of six hours of training comprised of instruction and participant interaction.
11999355|NCT00597935|Procedure|SSLF|sacrospinous ligament fixation (SSLF)
11999356|NCT00597935|Procedure|ULS|uterosacral vaginal vault ligament suspension (ULS)
11999357|NCT00597935|Behavioral|PMT|Pelvic muscle training and exercises (PMT)
11999358|NCT00597909|Drug|sodium phenylacetate and sodium benzoate injection 10% / 10%|5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11999359|NCT00597909|Drug|sodium phenylacetate and sodium benzoate injection 10% / 10%|2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11999360|NCT00597909|Drug|placebo solution (10% dextrose)|Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11999361|NCT00597896|Drug|pramipexole|po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
11999362|NCT00597870|Device|Endoluminal treament of thoracic lesions|Endoluminal treament of thoracic lesions with a thoracic stent-graft
11999363|NCT00597857|Drug|Hydrocortisone|Participants will receive a tapering low-dose of hydrocortisone in pill form for 10 days, twice a day, after the trauma.
11999364|NCT00597857|Drug|placebo|receipt of a placebo pill for 16 days
11999365|NCT00597844|Other|voice evaluation and fMRI|will undergo voice evaluation and fMRI prior to surgical rehabilitation of UVCP and in approximately one month and six months following treatment.
11999366|NCT00597844|Other|undergo voice evaluation and fMRI prior|in approximately one month and six months
11999367|NCT00597818|Drug|Cobiprostone|18 mcg cobiprostone capsules for oral administration
11999368|NCT00597818|Drug|Placebo|Matching placebo capsules for oral administration
11999369|NCT00597818|Drug|Non-steroidal anti-inflammatory drug|Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
11999370|NCT00597805|Behavioral|questionnaires/interviews|All patients who agree to participate will be interviewed for a baseline quality of life assessment prior to surgery. A brief in hospital interview will follow in the peri-operative period. In the ensuing months, patients will be interviewed at approximately 3, 6 and 12 months post-operatively (eg: 3 month interview will be done between 8-16 weeks and 6 month interview between 20-28 months post-operatively). Annual interviews in years two through five will be employed to determine areas for future study and solicit narrative on transition toward cancer survivorship.
11999429|NCT00597350|Dietary Supplement|Trigonella foenum-graecum (fenugreek)|2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart
11999430|NCT00597337|Behavioral|FearNot|Behavioral: Three sessions of FearNot!v.2.0 software interaction over a three-week period (each session lasting approximately 30 minutes)
11999371|NCT00597792|Device|NDO Full-thickness Plicator|A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.
11999372|NCT00597779|Device|Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)|Surgical stabilization of unstable intertrochanteric hip fractures using two commonly used implant categories
11999373|NCT00597766|Drug|Lidocaine|One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
11999374|NCT00597766|Drug|Triamcinolone + Lidocaine|Low Dose -- One-time injection of 20 mg triamcinolone: 1.5 cc of normal saline, 0.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
11999375|NCT00597766|Drug|Triamcinolone + Lidocaine|Standard Dose -- One-time injection of 40 mg triamcinolone: 1 cc of normal saline, 1 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
11999376|NCT00597766|Drug|Triamcinolone + Lidocaine|High Dose -- One-time injection of 60 mg triamcinolone: 0.5 cc of normal saline, 1.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
11999377|NCT00597753|Drug|peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
11999378|NCT00597753|Drug|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
11999379|NCT00597727|Drug|Peanut SLIT|Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
11999380|NCT00597727|Drug|Placebo SLIT|Liquid glycerin without peanut which are dosed under the tongue.
11999381|NCT00597714|Drug|Non-myeloablative Stem Cell Transplantation|The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. Group B's prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Patient evaluations will occur 2 times per week by physical exam for toxicity through day 45.
11999382|NCT00597701|Drug|Baclofen|Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.
11999383|NCT00597701|Drug|Placebo|Placebo
11999384|NCT00597701|Drug|Lorazepam|"Lorazepam was provided to all subjects (both arms of the study), as indicated by clinical condition. Standard symptom-triggered dosing of lorazepam for alcohol withdrawal was used. That is, the size and the frequency of the dose of lorazepam was determined by the severity of the alcohol withdrawal symptoms."
11999385|NCT00597688|Drug|Chlorhexidine gel|Oral mucosal application of chlorhexidine gel
11999386|NCT00597688|Drug|Placebo gel|Oral mucosal application of placebo gel
11999387|NCT00597675|Biological|Peanut OIT|Defatted peanut flour ingested daily as oral mucosal immunotherapy
11999388|NCT00597675|Biological|Placebo|Oat flour matched by weight and consistency that is ingested daily as a placebo
11999389|NCT00597662|Device|polylactide-caprolactone-trimethylenecarbonate copolymer|Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
11999390|NCT00597662|Device|Icodextrin 4%|1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
11999391|NCT00597649|Drug|Bicifadine|SR dosage form of 400 mg bid or tid for one year
11999392|NCT00597636|Behavioral|Questionaire, blood sample|Provide 30ml blood for laboratory assays Complete Health Questionnaire
11999393|NCT00597636|Behavioral|Questionaire, Blood sample|Provide 30ml blood for laboratory assays Complete Health Questionnaire
11999394|NCT00597623|Other|Adalimumab (Humira®)|syringes for injections under cutaneous dose = 40mg vol = 0.8 ml
11999395|NCT00597623|Other|Placebo|syringes under cutaneous vol = 8 ml
11999396|NCT00597610|Other|Transrectal ultrasound 3-D (TRUS)|Transrectal ultrasound (TRUS) is widely accepted as an accurate and effective technique for staging of rectal cancer. The decision to administer pre-operative chemotherapy/radiation therapy is often made based on the results of the TRUS. Three-dimensional TRUS (3-D TRUS) is a new modality that provides all of the information of traditional TRUS as well as the ability to provide three dimensional views of the tumor.
11999397|NCT00597597|Drug|Erlotinib|During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
11999398|NCT00597584|Drug|peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
11999431|NCT00597324|Procedure|coronary catheterisation|Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically
11999432|NCT00597311|Radiation|radiotherapy|"Short term radiotherapy 5x5 Gy during 5 days
~Chemoradiotherapy 50 Gy + 5Fu/Lv"
11999864|NCT00593450|Drug|bevacizumab|• 1.25 mg (0.05 mL)intravitreal injection
11999399|NCT00597584|Drug|Epoetin alfa or Epoetin beta|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
11999400|NCT00597558|Drug|Egg white protein|Egg white protein powder
11999401|NCT00597545|Procedure|Carotid endarterectomy|When a shunt is inserted to increase blood flow to the brain
11999402|NCT00597545|Device|Shunt|A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.
11999403|NCT00597532|Dietary Supplement|Soy|soy (soy protein supplementation 50 grams/day)
11999404|NCT00597532|Dietary Supplement|Milk|placebo (milk protein supplementation 50 grams/day)
11999405|NCT00597519|Drug|Fludarabine, Cyclophosphamide|"Fludarabine 25 mg/m2/day IV in the morning x 3 days (days -7, -6 and -5) for a total dose of 75 mg/m2 followed by Cyclophosphamide on days -6 and -5. 60mg/kg/day IV over 30-60 minutes x 2 days (days -6 and -5). High volume fluids should commence approximately 12 hours prior to drug and continue until 24 hours after second dose.
~Total Body Irradiation: 125 cGy x 11 doses (TID on days -3, -2, -1 and BID on day 0) for a total TBI dose of 1375 cGy. Pediatric patients unable to tolerate a TID dosing schedule can receive 150 cGy x 8 doses (BID on days -3, -2, -1, and 0). All patients will receive GVHD prophylaxis with 2 drugs: Cyclosporine A and Mycophenolate mofetil (MMF).
~Units should be given consecutively each over approximately 10-30 minutes.Pre-medication should include acetaminophen and diphenhydramine or hydroxyzine.G-CSF 5 mcg/kg/day IV/SQ (dose rounded to vial size to a maximum of 480 mcg) will be given from day +1 until ANC recovery."
11999406|NCT00597519|Procedure|Transplantation|The UCB ( Umbilical Cord Blood) collection known as a unit is processed to remove excess plasma and red cells, tested for sterility, HLA-typed, cryopreserved and stored. This protocol involves the administration of two UCB units from two different donors. The units will be thawed in the Cytotherapy Laboratory as per the current standard operating procedure.
11999407|NCT00597506|Drug|Bevacizumab|10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle
11999408|NCT00597506|Drug|Everolimus|10 mg Everolimus(RAD001) daily by mouth, days 1-28
11999409|NCT00597493|Drug|Sorafenib and Temozolomide|Temozolomide (50 mg per meter-squared of body surface area)every day by mouth in combination with sorafenib. Sorafenib will be taken by mouth twice every day. The dose of sorafenib will be 400 mg (2 x 200mg tablets).
11999410|NCT00597480|Drug|rhGH (Norditropine SimpleXx®)|the recommended dose in the EU of rhGH (Norditropine SimpleXx®
11999411|NCT00597480|Drug|rhGH norditropine simple Xx|"the dose to achieve a treat-to target value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day)"
11999412|NCT00597467|Device|VISA (comfilcon A) Silicone Hydrogel Soft contact lens|Test device
11999413|NCT00597467|Device|Acuvue 2 Soft Contact Lens|Control device
11999414|NCT00597454|Other|Patient Navigation|"we will conduct a detailed analysis of how the patient navigators' time is actually utilized by having them record a detailed log categorizing their activities as it relates to the elimination of recognized barriers to care. Second, we will measure the time interval from receipt of a suspicious mammogram to appropriate diagnostic evaluation and or treatment.
~We will measure the number of women who experience diagnostic and or treatment delay and whether the presence of a Patient Navigator enables delivery of coordinated care that avoids delays. Third, we will measure patients' satisfaction with aspects of their care, focusing particularly on care coordination using validated instruments designed for this purpose."
11999415|NCT00597441|Biological|Thymic Transplantation for Recipients of UCB transplant|Subjects with hematologic malignancies or bone marrow failure disorders will undergo umbilical cord blood transplantation and two months post transplant will have thymic tissue from a third party donor transplanted into the thigh muscle.
11999416|NCT00597428|Drug|Lubiprostone|24 mcg capsules twice daily (BID)
11999417|NCT00597428|Drug|Placebo|0 mcg capsules twice daily (BID)
11999418|NCT00597415|Drug|celecoxib|celecoxib 200mg
11999419|NCT00597415|Drug|placebo|placebo
11999420|NCT00597402|Drug|Avastin|Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury. Following completion of XRT, patients will receive treatment that includes 6 cycles of Avastin, beginning a minimum of 14 days after last XRT.
11999421|NCT00597402|Drug|Temozolomide|Daily temozolomide 75 mg/m2/day for 6.5 weeks of radiation treatment. Following completion of XRT, patients will receive treatment including temozolomide 200 mg/m2/day on the 1st 5 days of each 28-day cycle.
11999422|NCT00597402|Radiation|Radiation Therapy (XRT)|Treatment with standard XRT (radiation) for 6.5 weeks.
11999423|NCT00597402|Drug|Irinotecan|Following completion of XRT, patients will receive 6 cycles of treatment that includes irinotecan. Beginning a minimum of 14 days after last XRT, the irinotecan dose will depend on whether the patient is on enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED: 125 mg/m2.)
11999424|NCT00597389|Drug|Inderol (propranolol)|Children ingested a propranolol HCL 20 mg/5 ml solution twice daily for 10 days (and taper for 5 days). Medication was initiated within 12 hours post-trauma. Dose was calculated to be 2.5 mg/kg/d with a maximum dose of 40 mg.
11999425|NCT00597376|Other|Cerefolin NAC (a medical food)|Cerefolin NAC one tablet each day
11999426|NCT00597376|Other|Cerefolin NAC placebo|Placebo tablet once a day
11999427|NCT00597363|Device|Neptune P.A.D. (R)|The Neptune Pad ® (Biotronik GmbH & Co. KG, Berlin, Germany) is a soft and hydrophilic wound dressing, which has been developed to accelerate local hemostasis, reduce compression times, enable early ambulation and minimize the risk for bleeding complications. Neptune Pad ® consists of calcium alginate, which is cationically charged and exerts potent procoagulant properties.
11999428|NCT00597363|Other|conventional manual compression|The most common technique for puncture site management is manual compression. This technique requires an extended pressure on the puncture site, and after achievement of hemostasis a pressure bandage is applied for several hours at bed rest.
11999468|NCT00596999|Procedure|UCB and HPDSC|single dose of UCB followed by one unit of HPDSC
11999433|NCT00597298|Device|Threshold|Inspiratory muscle training program using a variable pressure device. An inspiratory muscle training device comprises a chamber having an opening for the passage of air to be inhaled and exhaled, and an inlet permitting air to be inhaled to enter the chamber and to pass to the opening. A one-way exhaust valve permits exhaled air entering through the opening to escape from the chamber, and another valve is provided to resist the entry of air to be inhaled into the chamber, the latter valve serving to vary the degree of resistance in dependence upon the volume of air that has passed through the inlet.
11999434|NCT00597298|Device|sham threshold|non-training physical activity
11999435|NCT00597272|Biological|KLH conjugates with GD2L and GD3L|6 vaccinations (on weeks 1, 2, 3, 8, 20 and 32) which will contain the same KLH conjugates with GD2L and GD3L. All vaccines contain KLH conjugates containing 30mcg of GD2L and 30mcg of GD3L and QS-DG or OPT-821. The initial 8 patients will receive the same QS-DG or OPT-821 vaccine dose in all of their vaccines. This dose will be 50 mcg for the first patient, 75 mcg for the second patient and 100 mcg for the third through eighth patients. In all subsequent patients the 1st, 4th and 5th vaccinations will include 150 mcg of OPT-821. The 2nd and 3rd vaccinations will contain 100 mcg of OPT-821 and the 6th vaccination will contain 200 mcg of OPT-821.
11999436|NCT00597259|Drug|Pegasys plus Entecavir|Pegasys 180 mcg in 0.5 mL solution administered sc once weekly for 24 weeks plus entecavir (0.5mg mg/capsule) 0.5 mg administered po daily for 24 weeks
11999437|NCT00597259|Drug|Entecavir|ETV 0.5 mg daily monotherapy for 144 weeks
11999438|NCT00597246|Drug|FACBC, Methionine|F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.
11999439|NCT00597246|Other|PET Scan|GE Advance PET scanner for sequential body imaging
11999440|NCT00597233|Drug|insulin aspart|
11999441|NCT00597233|Drug|soluble human insulin|
11999442|NCT00597233|Drug|insulin NPH|
11999443|NCT00597220|Dietary Supplement|Omega 3 (n-3 PUFA)|1 gram of n-3 PUFA containing DHA and EPA
11999444|NCT00597220|Drug|Placebo|Placebo
11999445|NCT00597207|Device|AutoPulse|Mechanical device that provides chest compression
11999446|NCT00597207|Other|Manual|Manual chest compression
11999447|NCT00597194|Procedure|Hernia repair|Hernia repair laparoscopically (LH) or by open operation (OH)
11999448|NCT00597181|Procedure|Trabeculectomy with mitomycin c|mitomycin c 0.2 mg/cc for 2 minutes
11999449|NCT00597181|Procedure|Ex-Press mini shunt with mitomycin c|mitomycin c 0.2 mg/cc for 2 minutes
11999450|NCT00597142|Device|Express™ Renal Premounted Stent System|"This device is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a:
~Single, de novo or restenotic (from PTRA) atherosclerotic lesion in the ostium of the renal artery
~Lesion length ≤15mm
~Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
~RVD 4.0-7.0mm"
11999451|NCT00597129|Biological|90Y-hPAM4|Single dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
11999452|NCT00597116|Drug|Vinorelbine|
11999453|NCT00597116|Drug|Vandetanib|once daily oral dose
11999454|NCT00597103|Other|Cognitive Function Testing-10 Tests|Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status
11999455|NCT00597103|Other|Sleep Assessment Testing|"Sleep Assessment will be performed using an Actiwatch with subjects wearing the watch for 72 hours continuously"
11999456|NCT00597103|Other|Periodic Leg Movement Syndrome Assessment|"Subjects will wear and Actiwatch on both legs for three consecutive nights."
11999457|NCT00597077|Other|Rate vs rhythm control strategies for atrial fibrillation|Rate vs rhythm control strategies for atrial fibrillation
11999458|NCT00597077|Other|Rate vs rhythm control strategies in atrial fibrillation|rate vs rhythm control strategies in atrial fibrillation
11999459|NCT00597064|Drug|prednisone|oral prednisone 40 mg/day for 15 +/- 5 days
11999460|NCT00597051|Drug|ARD-0403|
11999461|NCT00597038|Drug|Dasatinib and Dacarbazine (DTIC)|"Arm A/ Phase I Potential Dose Levels.
~Dose Level -1: Dasatinib 40 mg; DTIC 600 mg/m^2. Dose Level 1: Dasatinib 50 mg; DTIC 800 mg/m^2. Dose Level 2: Dasatinib 70 mg; DTIC 800 mg/m^2. Dose Level 3: Dasatinib 70 mg; DTIC 1000 mg/m^2.
~Arm B/Phase II Potential Dose Levels.
~MTD1: Dasatinib 70 mg; DTIC 1000 mg/m^2. MTD2: Dasatinib 70 mg; DTIC 800 mg/m^2. MTD3: Dasatinib 100 mg: DTIC 1000 mg/m^2."
11999462|NCT00597025|Dietary Supplement|Protein Food Bar Intelligent Indulgence|Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months
11999463|NCT00597025|Dietary Supplement|Protein Food Bar Intelligent Indulgence|Patients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days
11999464|NCT00597025|Dietary Supplement|Protein Food Bar Intelligent Indulgence|Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
11999465|NCT00597012|Procedure|Arthroscopic partial menisectomy|Arthroscopic partial meniscectomy is a surgical procedure that is performed to remove a piece of torn cartilage in the knee joint. Incisions for arthroscopy are quite small, usually about 1 centimeter each. The torn meniscus can be removed using a number of different instruments, including small shavers and scissors.
11999466|NCT00597012|Other|Standard physical therapy|Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks. This physical therapy regimen will have similar elements and goals as the postoperative intervention offered to Group 1 participants.
11999467|NCT00597012|Other|Postoperative rehabilitative physical therapy|This physical therapy is geared specifically toward rehabilitation after APM surgery.
11999469|NCT00596986|Drug|Duloxetine|Duloxetine 30mg up to 120mg per day.
11999470|NCT00596986|Behavioral|Cognitive Behavioural Analysis System of Psychotherapy|Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.
11999471|NCT00596973|Procedure|Surgical Treatment|Ileal transposition with sleeve gastrectomy
11999472|NCT00596960|Behavioral|Motivational Enhancement Therapy (MET)|MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
11999473|NCT00596960|Behavioral|Health education|Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
11999474|NCT00596947|Drug|prednisone|In this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20mg on day 5, none from day 6-on.
11999475|NCT00596947|Drug|rabbit antithymocyte globulin|Participants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection.
11999476|NCT00596947|Drug|Tacrolimus|Participants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study.
11999477|NCT00596947|Drug|Prednisone|Participants in this group continued on prednisone indefinitely. Participants began with 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely.
11999478|NCT00596947|Drug|Mycophenolate mofetil|Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.
11999479|NCT00596947|Drug|Mycophenolate mofetil|Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.
11999480|NCT00596934|Drug|metreleptin|0.1 mg/kg/day once a day via subcutaneous injections
11999481|NCT00596895|Dietary Supplement|Isoflavone|Ingested 47 mg of isoflavone in three 8 oz servings per day
11999482|NCT00596882|Other|Message Prime|Participants will be randomized to genetic prime messages or threat only message at the time of the intial telephone screen. Following phone screen, all eligibleparticipants will receive 13 weeks of Chantix with smoking cessation counseling.
11999483|NCT00596882|Other|Message Prime|Particpants will be randomized into 1 of 2 groups. 1 group will recieve a message detailing the negative helaht consequenes of smoking and the other group will receive this information along with information about the genetic incluences on smoking behavior.
11999484|NCT00596856|Behavioral|Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT|The RCT will compare passive distribution of guidelines by mail to an in-office intervention consisting of guideline distribution combined with educational outreach providing training in guideline use and patient mediated information provided by the risk and referral assessment tool (PORRT). The three-arm trial will consist of 25 medical practices that have never participated in IMB and 25 practices that are currently participating, both of which will receive the guidelines through the mail, and 25 practices currently participating in IMB that will receive the more intense in-office training intervention.
11999485|NCT00596843|Behavioral|Motivational interviewing|6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
11999486|NCT00596843|Behavioral|Educational intervention|6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos
11999487|NCT00596830|Drug|CP-751,871 (Figitumumab)|CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
11999488|NCT00596830|Drug|Carboplatin|Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
11999489|NCT00596830|Drug|Paclitaxel|Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
11999490|NCT00596830|Drug|Carboplatin|Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
11999491|NCT00596830|Drug|Paclitaxel|Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
11999492|NCT00596817|Drug|Placebo|capsules, daily, orally
11999493|NCT00596817|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets, daily, orally
11999494|NCT00596804|Drug|veltuzumab|once weekly intravenous dosing for 4 weeks
11999495|NCT00596791|Drug|tafluprost|prostaglandine analoque
11999496|NCT00596778|Other|chest physiotherapy|The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion.
11999865|NCT00593424|Other|Low Fat/High Carbohydrate|Low Fat/High Carbohydrate for 6 week period
11999497|NCT00596765|Behavioral|Neuropsychological Cognitive Behavioral Therapy|Neuropsychological Cognitive Behavioral Therapy encompasses 2 foci: First emphasis is on neuropsychological compensatory strategies for the treatment of deficits in attention, memory, and executive functions. Secondly, cognitive behavioral intervention techniques are employed to support the patient in the process of coping with chronic illness: i.e. improve regulation of negative affect, diversify the impaired self-concept after acquired brain injury, and adjust important life-goals to changed circumstances.
11999498|NCT00596752|Drug|Alprostadil|"Active Substance: Prostaglandin E1
~Pharmaceutical Form: solution for infusion
~Concentration: 40 μg b.d.
~Route of Administration: intravenous infusion"
11999499|NCT00596752|Other|Placebo|"Active Substance: Lactose
~Pharmaceutical Form: solution for infusion
~Concentration: 40 μg b.d.
~Route of Administration: intravenous infusion"
11999500|NCT00596726|Device|IMPELLA LP/LD 5.0|IMPELLA LP/LD 5.0 Support System is intended to be used for up to seven (7) days as a left ventricular cardiac assist device for postcardiotomy patients who, despite having been weaned from cardiopulmonary bypass (CPB), require hemodynamic support
11999501|NCT00596700|Device|Given® Diagnostic System including PillCamTM SB Capsules|"Device for detection of pathologies as a tool in the diagnosis of gastrointestinal disorders.
~An ingestible,disposable video camera that transmits high quality images of the small intestinal mucosa"
11999502|NCT00596687|Drug|Insulin glargine|Insulin glargine once daily SQ
11999503|NCT00596687|Drug|Regular insulin|Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO
11999504|NCT00596687|Drug|Insulin glulisine|scheduled glulisine given SQ at mealtime TID; none given if patient NPO
11999505|NCT00596674|Behavioral|Lifestyle Counts|8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
11999506|NCT00596674|Other|Attention Control|8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
11999507|NCT00596661|Device|TriMaxx Coronary Stent placement|Angioplasty with coronary artery stent placement
11999508|NCT00596648|Drug|XL184|Capsules administered orally daily
11999509|NCT00596648|Drug|erlotinib|Tablets administered orally daily.
11999510|NCT00596635|Dietary Supplement|Once Daily Cranberry Capsule|650mg capsule pure cranberry powder
11999511|NCT00596635|Dietary Supplement|Twice Daily Cranberry Capsules|One 650mg cranberry capsule administered twice per day
11999512|NCT00596622|Drug|Lithium|Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
11999513|NCT00596609|Drug|Intrathecal Morphine|"In the IT morphine group, prior to IT morphine injection (within 15 minutes of the injection), the neurophysiologist will be asked to obtain a set of TceMEP recordings. The recordings collected at this time will be labeled Baseline. These will serve as controls for subsequent recording comparisons.
~In the IT morphine group, the time of IT morphine injection will be recorded, as well as the dose. A timer will be started. The neurophysiologist will then be asked to collect four additional sets of TceMEP recordings, at 5, 10, 20, and 30 minutes after morphine injection."
11999514|NCT00596596|Drug|prucalopride|0,5 mg once daily
11999515|NCT00596596|Drug|prucalopride|1 mg once daily
11999516|NCT00596596|Drug|2 mg prucalopride|2 mg once daily
11999517|NCT00596596|Drug|4 mg prucalopride|4 mg once daily
11999518|NCT00596596|Other|Placebo|placebo once daily
11999519|NCT00596583|Drug|DYME|2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
11999520|NCT00596583|Drug|DYME|2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
11999521|NCT00596570|Procedure|PCI|Percutaneous coronary interventiom
11999522|NCT00596557|Drug|everolimus|reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8.
11999523|NCT00596544|Behavioral|questionnaires|will be offered referral to the Sexual Health Clinic (SHC) at MSKCC for evaluation and possible treatment. The effectiveness and compliance of the intervention offered at the SHC will be assessed at approximately 3, 6 and 12 months using the FSFI, SAQ, CES-D, MSC and IES. At each evaluation they will complete a Health Surveillance Form (HSF). They will have completed the study at 12 months after entering the study or at the time they have evidence of recurrent disease requiring treatment
11999524|NCT00596544|Behavioral|questionnaires|Those women who have a FSFI score > 26 will be reassessed at approximately 3, 6 and 12 months. They will complete the FSFI, SAQ, CES-D, IES, MSC and HSF at each assessment. They will be followed out until 12 months after entering the study or until they have evidence of recurrent disease.
11999525|NCT00596531|Drug|Acamprosate|Oral administration, 666 mg, tid, for 4 months
11999526|NCT00596531|Drug|Placebo|Oral administration of 2 pills, tid, for 4 months
11999527|NCT00596518|Drug|PF-00734200|The drug is administered as a single dose of four 5-mg tablets
11999528|NCT00596492|Drug|DYME|2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
11999529|NCT00596492|Drug|DYME|2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
11999530|NCT00596479|Drug|Filgrastim (rG-CSF)|
11999531|NCT00596466|Drug|pregabalin|pregabalin
11999532|NCT00596453|Drug|Ciprofloxacin hydrochloride|250 mg Ciprofloxacin hydrochloride twice a day for 14 days
11999533|NCT00596453|Drug|Placebo|Placebo twice a day for 14 days
11999534|NCT00596440|Drug|Transdermal nicotine patch|8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.
11999535|NCT00596427|Drug|Colesevelam HCL|Colesevelam HCL 625 mg: 3 tablets twice per day
11999536|NCT00596427|Drug|Placebo|Placebo tablets: 3 tablets twice per day
11999537|NCT00596414|Procedure|transjugular liver biopsy|liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
11999538|NCT00596414|Drug|placebo|
11999539|NCT00596414|Drug|midazolam|
11999540|NCT00596414|Drug|midazolam + pethidine|
11999541|NCT00596375|Procedure|Lubricant Instillation|Lubricant jelly instilled in urethra prior to catheterization
11999542|NCT00596375|Drug|Lidocaine Lubricant|2% Lidocaine lubricant instillation prior to urethral catheterization
11999574|NCT00596024|Dietary Supplement|lutein/zeaxanthin|daily supplementation of lutein and zeaxanthin at dose of 12 mg/day
11999575|NCT00596024|Dietary Supplement|placebo|placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients
11999543|NCT00596362|Drug|AVASTIN|a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
11999544|NCT00596349|Behavioral|questionnaires|study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL-Cancer Survivor FACT-Ovarian SF-36 (general QOL scale) CES-D (depression scale) Impact of Events Scale (anxiety scale) FACT-GOG-NTX (neurotoxicity scale) Female Sexual Functioning Index (FSFI) Cognition Testing Perception of disease chronicity/acuity Concerns about Recurrence Report of surveillance type, frequency, utility Health behaviors Self-report of co-morbidities Self-report of potential unmet needs Background information form List of current medications Patient-defined QoL domains
11999545|NCT00596349|Behavioral|questionnaires|study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL-Cancer Survivor FACT-Ovarian SF-36 (general QOL scale) CES-D (depression scale) Impact of Events Scale (anxiety scale) FACT-GOG-NTX (neurotoxicity scale) Female Sexual Functioning Index (FSFI) Cognition Testing Perception of disease chronicity/acuity Concerns about Recurrence Report of surveillance type, frequency, utility Health behaviors Self-report of co-morbidities Self-report of potential unmet needs Background information form List of current medications Patient-defined QoL domains
11999546|NCT00596349|Behavioral|questionnaires|study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL- Cancer Survivor, FACT-Ovarian, SF-36, CES-D, IES, FACT-GOG-NTX, FSFI, Cognition Testing, Perception of disease chronicity/acuity, Report of surveillance type, frequency, utility, Health behaviors, Self-report of co-morbidities, Self-report of potential unmet needs, Background information form, List of current medications,Patient-defined QoL domains
11999547|NCT00596336|Drug|Imiquimod cream|Imiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6
11999548|NCT00596336|Drug|influenza vaccine|trispecific influenza vaccine 0.5 ml subcutaneously
11999549|NCT00596310|Other|CT|Screening CT
11999550|NCT00596297|Drug|bevacizumab|Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline
11999551|NCT00596297|Procedure|pars plana vitrectomy|4 weeks after baseline
11999552|NCT00596284|Behavioral|Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)|Cognitive behavioral therapy (CBT) will consist of 8 to 10 sessions over a period of 10 to 12 weeks. Each CBT session will last about 1 hour and will include meeting with a study staff member to discuss anxiety and how to cope with it. Participants will also complete practice activities at home for about 20 minutes per day.
11999553|NCT00596284|Behavioral|Enhanced Usual Care (EUC)|Following in-person meetings, participants will receive weekly phone calls for 3 months, followed by biweekly phone calls for the next 3 months.
11999554|NCT00596271|Biological|IC51|
11999555|NCT00596271|Biological|HAVRIX|
11999556|NCT00596271|Other|Placebo|
11999557|NCT00596258|Drug|A-007|applied topically for two 28-day cycles of 14 consecutive days of treatment each to the uterine cervix
11999558|NCT00596245|Drug|MT400|MT 400, naproxen sodium 550mg
11999559|NCT00596219|Drug|celecoxib|celecoxib
11999560|NCT00596206|Drug|leflunomide|20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months
11999561|NCT00596180|Drug|HBOT|total body exposure to greater than atmospheric pressure oxygen
11999562|NCT00596167|Drug|Intravenous antibiotics|Each subject will receive a single dose of 15 mg/kg vancomycin; 2 mg/kg gentamicin and 250 mg levofloxacin administered intravenously over a one-hour infusion period through the venous limb of their HD access (or tunneled catheter) via an IV pump.
11999563|NCT00596154|Other|Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide|"The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.
~On day 2 you will be admitted to the hospital and will receive 3 other drugs:
~Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.
~Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle."
11999564|NCT00596141|Device|OroScience Topical Oral Wound Emulsion|TOWE will be applied 3 times daily for a period of 7 days by the patient dispensing TOWE into a disposable dental tray and placing the dental tray over the dental arch and covering the surgical site.
11999565|NCT00596128|Behavioral|Implementation of SOP|SOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine
11999566|NCT00596115|Drug|R(+) pramipexole dihydrochloride monohydrate|20 mg tid per day orally
11999567|NCT00596102|Biological|Japanese Encephalitis purified inactivated vaccine|Japanese Encephalitis purified inactivated vaccine
11999568|NCT00596076|Behavioral|Back School|"All the workers undergo a clinical examination for low back pain, by two trained practitioner. Those workers who are diagnosed for mechanical low back pain during the last six months fulfill a self report Quality of Life Questionnaire (SF36). The objective level of low back pain will obtain by a visual analogue scale. Then a back school training course will be held in 6 sessions, in 6 consecutive weeks. Two previously trained physiotherapists are responsible for the training course. Each series will have 10 participants. They will learn vertebral column anatomy and its function at the first session. The proper posture and exercises to reduce or inhibit low back pain are taught in the next 4 sessions. The 6th session is arranged for answering questions and checking how exercises are performed.
~A visual analogue scale and quality of life assessment will be held at the end of the last session and the end of the sixth month."
11999569|NCT00596063|Biological|Wosulin R|Penfill cartridges; Single Dose, 0.2 IU/ kg;
11999570|NCT00596063|Biological|Novolin R|Penfill cartridges; Single Dose, 0.2 IU/ kg;
11999571|NCT00596050|Drug|ketamine and midazolam|ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
11999572|NCT00596050|Drug|etomidate, fentanyl, and lidocaine|etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
11999573|NCT00596037|Drug|Growth hormone - LB03002|
11999576|NCT00596011|Drug|Polyphenon E|Polyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP.
11999577|NCT00596011|Drug|Placebo|Matching placebo BID
11999578|NCT00595985|Drug|sorafenib|sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
11999579|NCT00595972|Drug|ECF-endostar|Epirubicin 50mg/M2 D1, Cisplatin 60mg/M2 D1, FU 500mg/M2 D1-5, endostar 7.5mg/M2 D1-14, treatment cycle repeat every 3 weeks. Treatment should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
11999580|NCT00595959|Device|CLiRpath Photoablation System|Use of CLiRpath Laser Catheter to improve vessel lumen diameter.
11999581|NCT00595946|Drug|Lubiprostone|24 mcg capsules twice daily (BID)
11999582|NCT00595946|Drug|Placebo|0 mcg capsules twice daily (BID)
11999583|NCT00595933|Other|sugar-free chewing gum|Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
11999584|NCT00595933|Other|chewing gum|Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
11999585|NCT00595933|Other|mouth rinse|Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire
11999586|NCT00595933|Other|mouth rinse|Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
11999587|NCT00595933|Drug|mouth spray|Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
11999588|NCT00595933|Drug|mouth spray|Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
11999589|NCT00595920|Biological|Tovaxin|2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
11999590|NCT00595881|Device|Bedside emergency ultrasound|Ultrasound will be performed on the lesion in question.
11999591|NCT00595868|Drug|Varenicline|0.5 milligrams two times per day for 3 days, then 1.0 milligrams two times per day for an addition 11 days - 2 months
11999592|NCT00595868|Drug|Placebo|same as Varenicline arm
11999593|NCT00595855|Procedure|trabeculectomy|Cairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis
11999594|NCT00595855|Procedure|deep sclerectomy|deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)
11999595|NCT00595829|Drug|XL019|XL019 capsules administered orally
11999596|NCT00595816|Other|physical training and counselling|Neuromuscular training program 3 times per week 30 minutes per session and counselling on back problems and other musculosceletal injuries
11999597|NCT00595790|Biological|IC51|
11999598|NCT00595777|Behavioral|EPAT© Educational Package|The EPAT package consists of an education programme, which deals with the known common barriers to effective pain control and the bedside pain tool. The pain tool is uniquely incorporated into the vital signs chart to enable a systematic approach to cancer pain assessment and review. EPAT consists of 2 steps: step 1 is a colour-coded pain assessment on the bedside vital signs chart. Patients with moderate or severe pain on step 1 will progress to to step 2, which helps to identify the aetiology of the pain, screening for opioid side effects and is linked via flags to simple management plans. The intervention will be delivered to the clusters randomised to the intervention, after collection of baseline data (pre-intervention data) on 50 patients.
11999599|NCT00595764|Behavioral|Manual-guided Physician Management (PM)|Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.
11999600|NCT00595764|Behavioral|Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)|CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.
11999601|NCT00595738|Other|Standard of care therapy for severe decompensated heart failure|Standard of care therapy for severe decompensated heart failure
11999602|NCT00595725|Other|Lymphatic Mapping|Intra-Operative Lymphatic Mapping
11999603|NCT00595712|Procedure|Iliac crest allograft|Opening wedge osteotomy of proximal tibia with allograft from iliac crest
11999604|NCT00595712|Procedure|Iliac crest autograft|open wedge osteotomy of proximal tibia using autogenous iliac bone graft
11999605|NCT00595699|Drug|escitalopram|10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study
11999606|NCT00595699|Drug|placebo|Placebo
11999607|NCT00595686|Drug|SNX-5422|dose escalated; tablets every other day; undetermined duration until disease progression
11999608|NCT00595673|Drug|PB127 for injectable suspension|0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.
11999609|NCT00595660|Procedure|FNA - fine needle aspiration|Fine Needle aspiration
11999610|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
11999611|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
11999612|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
11999613|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
11999614|NCT00595647|Device|Drug eluting stent|Implantation of stent
11999615|NCT00595647|Device|Bare metal stent|Implantation of stent
11999616|NCT00595621|Device|Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)|Multi-Channel Phased Gastric Pacemaker (MGP-1)
11999617|NCT00595608|Drug|Sterimar Spray|Post-op nasal spray, three times a day
11999618|NCT00595608|Drug|Generic homemade nasal saline spray (salt and water)|post op nasal saline spray in syringe, three times a day
11999619|NCT00595582|Dietary Supplement|curcumin + bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
11999620|NCT00595569|Behavioral|Flexible insulin therapy (FIT)|Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each
11999623|NCT00595543|Drug|Bromfenac|1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
11999624|NCT00595543|Drug|Ketorolac|1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
11999625|NCT00595543|Drug|Diclofenac|1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
11999626|NCT00595530|Drug|ketamine|"Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr.
~Dosing Regimen:
~Patients begin the ketamine infusion at 0.05 mg/kg/hr.
~4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if:
~patient's pain has not improved to an acceptable level
~side effects remain acceptable
~4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr
~4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
~Maximum dose of ketamine is limited to 300 mg per 24 hrs
~Patient may receive ketamine up to 72 hrs after initiation."
11999627|NCT00595517|Drug|Esomeprazole 20 mg|Esomeprazole 20 mg once daily
11999628|NCT00595504|Drug|Ramelteon|Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.
11999629|NCT00595504|Drug|Placebo|Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.
11999630|NCT00595491|Biological|Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage|Bronchoalveolar lavage is performed in the lingula without instillation of diluent or allergen. A 2ml aliquot of diluent is instilled into the right upper lobe. The procedure is repeated in the right middle lobe with instillation of 2ml of Cat or Mite allergen. A test dose of allergen is administered first. This will consist of 2ml allergen at 1/10th the threshold concentration for Cat or DF Mite Allergen or at 1/30th the threshold concentration for DP Mite Allergen. If on visual inspection through the bronchoscope there is no evidence of reaction to the test dose, a 2nd allergen challenge is done in the right middle lobe using 2ml of full-dose allergen. After a 1,6, or 24hr recovery period, a single 2nd bronchoscopy is performed after delivery of allergen extract and diluent and 1 Tbsp of blood is obtained. Bronchoalveolar lavage will be obtained from the lobes in which the diluent and allergen were instilled. OFDI and endobronchial brushing of the airways will also be performed.
11999631|NCT00595478|Behavioral|Motivational Enhancement Therapy (MET)/CBT+CM|Behavioral Treatment
11999632|NCT00595478|Behavioral|Motivational Enhancement Therapy (MET)/CBT|Behavioral Treatment
11999633|NCT00595465|Biological|Japanese Encephalitis purified inactivated vaccine|IC51 6 mcg i.m. injection on Day 0 and Day 28
11999634|NCT00595426|Drug|YM150|Oral
11999635|NCT00595426|Drug|Warfarin|Oral
11999636|NCT00595413|Drug|Placebo matched to atacicept|Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
11999637|NCT00595413|Drug|Atacicept: with loading dose|Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
11999638|NCT00595413|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.
11999639|NCT00595413|Biological|Adalimumab|Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
11999640|NCT00595387|Other|Supportive Psychotherapy|Participants will attend 18 supportive therapy sessions over 5 months. Supportive psychotherapy focuses on reflecting and expressing feelings about current life issues. Participants are supported and comforted when coping with difficult situations, depression, mood swings, or anger.
11999641|NCT00595387|Other|Cognitive Behavioral Therapy (CBT)|Participants will attend 18 CBT sessions over 5 months. CBT for depression targets depressive symptoms through a range of different treatments. This includes psychoeducation about the disorder and educating patients about the role of thoughts and behaviors in the maintenance of depressed mood. CBT also includes mood and activity monitoring, activity scheduling, and teaching participants to critically investigate and challenge negative thoughts and core beliefs that help to maintain depression.
11999642|NCT00595374|Drug|insulin detemir|
11999643|NCT00595374|Drug|insulin NPH|
11999644|NCT00595374|Drug|insulin aspart|
11999645|NCT00595361|Drug|salmeterol|salmeterol 50 micrograms twice daily for 2 weeks
11999646|NCT00595335|Drug|Rituximab|Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
11999647|NCT00595335|Drug|Saline|Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
11999648|NCT00595335|Drug|Methylprednisolone|Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.
11999649|NCT00595322|Other|bevacizumab and radiation (IMRT)|bevacizumab 10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (cycle defined as 28 days). If the tumor volume remains < 40 cc, the patient will undergo stereotactic radiotherapy with IMRT (30Gy) beginning anywhere from day 7-10 of cycle 2 (5 doses of 6 Gy over 2 and a half weeks)
11999650|NCT00595309|Biological|IC51|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization
11999651|NCT00595296|Device|GeneSearch™ Breast Lymph Node (BLN) Assay|The GeneSearch™ BLN Assay is a real time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) assay that detects the presence of breast tumor cell metastasis in lymph nodes through the detection of gene expression markers present in breast tissue, but not in nodal tissue (cell type specific messenger RNA).
11999652|NCT00595283|Behavioral|Parent Child Interaction Therapy-Emotion Development (PCIT-ED)|PCIT-ED includes fourteen 1-hour therapy sessions over 14 weeks. Sessions will focus on positive parent-child interactions skills, ways to manage emotions, and relaxation techniques.
11999653|NCT00595283|Behavioral|Developmental Education Parenting Intervention (DEPI)|DEPI includes 14 weekly, 1-hour education sessions covering a range of child development and parenting topics. Classes are in a small group format and will emphasize emotional and social development.
11999654|NCT00595270|Biological|IC51|
11999655|NCT00595257|Device|centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)|autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
11999768|NCT00594217|Other|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
11999656|NCT00595244|Drug|PB127 for injectable suspension|0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.
11999657|NCT00595231|Drug|SYN111|500 mg for 1 week followed by 1000 mg for 7 weeks
11999658|NCT00595231|Drug|Placebo|0 mg tablets
11999659|NCT00595218|Behavioral|Physician behavior related to Patient Preference Survey|Access to initial Patient preference survey results
11999660|NCT00595218|Other|Patient Preference Results|Knowledge of Patient Preference Results
11999661|NCT00595205|Other|Hospital log review.|Reviewing of the hospital log to monitor for the occurrence of intussusception.
11999662|NCT00595166|Device|Vaginal Speculum Sheath|Patients received the sheathed speculum exam: The clinician will begin to place the sheath onto the speculum. The sheath is attached to a thin piece of cardboard. The proximal end of the cardboard is placed between the speculum blades and is pushed toward the speculum handle. The blades of the speculum are simultaneously guided to enter the 2 pockets of the sleeve, like fingers going into a glove. The speculum exam will then be completed according to usual procedures. In the event the sheathed speculum exam is unsatisfactory the clinician will do standard of care (the clinician's usual routine at the bedside).
11999663|NCT00595153|Drug|Pulmicort|inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
11999664|NCT00595140|Drug|pegvisomant|growth hormone receptor antagonist pegvisomant in patients´ individual dose
11999665|NCT00595140|Drug|combination with somatostatin analogue octreotide|s.c., 100µg, one time
11999666|NCT00595140|Drug|combination with dopamine agonist cabergoline|oral, 0.5mg, one time
11999667|NCT00595127|Drug|Cyclophosphamide|Cyclophosphamide (10mg/kg/day x 4days)
11999668|NCT00595127|Drug|Fludarabine|Fludarabine (30mg/m^2/day x 5 days)
11999669|NCT00595127|Radiation|Total body irradiation (TBI)|TBI (450 cGY in a single fraction)
11999670|NCT00595101|Drug|PF-03187207|
11999671|NCT00595101|Drug|Latanoprost 0.005%|
11999672|NCT00595101|Drug|PF-03187207 Vehicle|One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
11999673|NCT00595101|Drug|Latanoprost Vehicle|
11999674|NCT00595088|Biological|BC-819/PEI|Papillary tumors will be resected with the exception of one marker tumor that will remain to examine the effects of the treatment on the remaining tumor. Study treatments will consist of an induction course of six weekly instillations of 20 mg of DTA-H19/PEI into the urinary bladder. Intravesical therapy will be delivered through a Foley catheter. Patients will be instructed to hold the dose in the bladder for two hours after administration. If the patient has a complete response, then she/he will be eligible to receive three additional courses of 3 weekly intravesical administrations of the same dose of investigational product every 12 weeks.
11999675|NCT00595075|Drug|Ramelteon|Ramelteon 8 mg tablet by mouth x 1 dose
11999676|NCT00595075|Drug|placebo|placebo identical in appearance to active experimental drug x 1 dose
11999677|NCT00595062|Radiation|Intra Operative Radiation Therapy (IORT)|Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT)
11999678|NCT00595049|Drug|bosentan|Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid
11999679|NCT00595023|Device|GeneSearch™ Breast Lymph Node (BLN) Assay|The GeneSearch™ BLN Assay is a real time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) assay that detects the presence of breast tumor cell metastasis in lymph nodes through the detection of gene expression markers present in breast tissue, but not in nodal tissue (cell type specific messenger RNA).
11999680|NCT00595010|Behavioral|SafeCare|Treatment will be based on an updated version of the SafeCare program, which specifically addresses parenting and discipline associated with child physical abuse. Participants will receive services from Comprehensive Home-Based Services.
11999681|NCT00594997|Behavioral|Education|Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer
11999682|NCT00594997|Behavioral|Control (pre and post surveys)|Students fill out a pre and post survey and then receive the same intervention given to the controls.
11999683|NCT00594984|Drug|Cetuximab|IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
11999684|NCT00594984|Drug|Irinotecan|IV solution, IV, Q3W, 350 mg/m2, until progression
11999685|NCT00594984|Drug|Brivanib|Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
11999686|NCT00594984|Drug|Brivanib|Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
11999687|NCT00594984|Drug|Brivanib Placebo|Oral, tablet, QD, until progression
11999688|NCT00594971|Other|Organisational intervention|A shared care approach in which extra effort is put into improving the communication between the hospital and the primary sector.
11999689|NCT00594971|Other|Referral to a specialist palliative care team.|Discharge with referral to a specialist palliative care team. This is a patient-centred shared care model in which the palliative team helps to organise the patient's treatment and care.
11999690|NCT00594958|Biological|IC51|6 mcg, intramuscularly [i.m.], 0.5 mL
11999691|NCT00594945|Drug|Clonazepam|1 Dose
11999692|NCT00594932|Drug|mycophenolate mofetil|First treatment month: mycophenolate mofetil ascending doses orally Second treatment month to end of study: mycophenolate mofetil 3 gms/day (or less if tolerance issues arise)
11999693|NCT00594932|Other|placebo|"oral placebo will be given in ascending doses during the first month and at full dose during the second and third month (or at lower dose if tolerance issues warrant). During the fourth month mycophenolate mofetil will be given in ascending doses to 3 gms/day (or less if tolerance issues arise) and continues until the end of the study at 6 months."
11999694|NCT00594906|Drug|Teriparatide|Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
11999695|NCT00594906|Drug|Placebo|Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
11999696|NCT00594893|Procedure|Mini Incision Approach|Mini Incision Approach
11999697|NCT00594893|Procedure|2 Incision Approach|2 Incision Approach
11999698|NCT00594880|Drug|Pegylated Interferon-alpha 2a, 180 mcg/week sc|Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
11999699|NCT00594880|Drug|Pegylated Interferon-alpha 2a, 90 mcg/week sc|Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
11999700|NCT00594867|Drug|Acetaminophen - 4 grams per day + Placebo|Acetaminophen - 4 grams per day + Placebo
11999701|NCT00594867|Drug|Aspirin - 325 mg per day + Placebo|Aspirin - 325 mg per day + Placebo
11999702|NCT00594867|Drug|Acetaminophen 4 gram per day + Aspirin 325 mg per day|Acetaminophen 4 gram per day + Aspirin 325 mg per day
11999703|NCT00594854|Drug|PN400 (VIMOVO)|PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid).
11999704|NCT00594854|Drug|Diclofenac/Misoprostol|Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.
11999705|NCT00594841|Procedure|Open Reduction Internal Fixation of AC joint dislocation|"Definitive surgical treatment (i.e., ORIF) will be performed within 28 days of the injury. In all cases the procedure will be performed by an orthopedic staff surgeon with the assistance of a fellow/resident(s). The operating surgeon will determine the positioning of the patient for surgery. ORIF of the AC joint dislocation will be carried out as follows:
~Anatomic reduction of the AC joint
~Definitive fixation with a hook plate and screws"
11999706|NCT00594841|Other|Non operative treatment of AC joint dislocation (sling)|Standard protocol for conservative treatment will consist of the implementation of a sling, for shoulder support and patient comfort, for four weeks followed by physiotherapy. Pendulum exercises may be implemented at any time as dictated by the attending surgeon.
11999707|NCT00594828|Device|CoaguChek (Patient self testing)|Patients will test their INR at home either biweekly, weekly or every 2 weeks using a CoaguChek point of care meter and communicate with the healthcare provider via an internet based expert system
11999708|NCT00594828|Device|Anticoagulation Management Service (AMS)|Patients will attend the AMS for six months and have their INR checked every 4-6 weeks or more frequently, at the discretion of the clinician
11999709|NCT00594815|Drug|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine|Immunochemotherapy
11999710|NCT00594789|Other|Information letters|Information letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed.
11999711|NCT00594776|Device|Cone Beam CT Scan|The Cone Beam Computerized Tomographic (CBCT) device utilizes computerized tomographic technology, a special digital imaging plate and a computer to create a three-dimensional image. The special imaging plate and software allow for small details to be imaged without tissue overlap.
11999712|NCT00594737|Drug|memantine hydrochloride|memantine hydrochloride oral tablets, 10mg po bid
11999713|NCT00594724|Procedure|MRI|Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
11999714|NCT00594698|Drug|PB127 for injectable suspension|0.175 mg/kg diluted in 150 mL 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes
11999715|NCT00594659|Behavioral|Psychotherapy|Nine session treatment
11999716|NCT00594659|Behavioral|Computerized Psychotherapy|Nine session computer delivered treatment
11999717|NCT00594659|Behavioral|Motivational enhancement therapy|Two session treatment
11999718|NCT00594646|Drug|TRUVADA + raltegravir|TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
11999719|NCT00594633|Other|donepezil and questionaires|Patients will undergo a brief cognitive evaluation prior to (baseline/Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 2) ,Cognitive Re-Evaluation (about 6 months after discontinuation of Donepezil). Then pt will be tx with donepezil, an acetylcholinesterase inhibitor. They will undergo a four-week dose titration (i.e., 5mg QD during weeks 1-4) to reach a final dose of 10mg QD of oral donepezil there after for a maximum of 24 weeks.
11999720|NCT00594620|Dietary Supplement|Flav-ein capsules|Soy/isoflavone supplementation
11999721|NCT00594620|Drug|Placebo|Placebo
11999722|NCT00594607|Device|AN69ST dialysis membrane|AN69ST is the filter that the blood goes through during hemodialysis
11999723|NCT00594607|Device|Fx8 (Fresenius)|Polysulphone dialysis membrane
11999724|NCT00594594|Other|Probiotic Lactobacillus GR-1 and RC-14|Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months
11999725|NCT00594581|Drug|Juvista (avotermin) plus placebo, standard-care (within-subject controls)|Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin
11999726|NCT00594568|Drug|LY450139|Administered orally once daily
11999727|NCT00594568|Drug|Placebo|Administered orally once daily
11999728|NCT00594555|Drug|Imatinib Mesylate|Imatinib Mesylate: 400mg po BID every day. Imatinib Mesylate will be administered Day 2 to Day 15
11999729|NCT00594555|Drug|CLAG|"Cladribine: 5mg/m2 administered through a 2 hour intravenous infusion daily for 5 consecutive days starting on Day 2
~Cytarabine: 2gm/m2 administered through a 4 hour intravenous infusion starting 2 hours after the ignition of Cladribine for 5 days starting on Day 2
~G-CSF: 300mcg sc for 6 days starting at 24 hours (Day 1) before the first dose of Cladribine; administration starting on Day 1 for 6 days"
11999730|NCT00594542|Drug|lidocaine|Each group is the appropriate concentration of lidocaine with epinephrine for local anesthesia at the beginning of each Mohs stage and the reconstruction.
11999731|NCT00594529|Procedure|Surgery|Liver resection for metastatic liver lesions
11999732|NCT00594516|Drug|tapentadol (CG5503) Immediate Release IR|21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period
11999769|NCT00594204|Drug|varenicline tartrate (CP-526, 555-18)|1 mg twice a day for 12 weeks, starting with a 1-week titration period.
11999770|NCT00594204|Drug|Placebo|matching placebo 1 tablet twice a day for 12 weeks
11999733|NCT00594516|Drug|tapentadol (CG5503) Extended Release (ER)|During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second
11999734|NCT00594516|Drug|tapentadol (CG5503) Immediate Release (IR)|Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second
11999735|NCT00594503|Drug|Hyperbaric oxygen therapy|Total body exposure to increased atmospheric pressure oxygen
11999736|NCT00594477|Radiation|IMRT|
11999737|NCT00594464|Drug|Rotigotine|"2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch;
~Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h;
~One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery."
11999738|NCT00594438|Device|Synthes Reamer-Irrigator-Aspirator (RIA)|A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram (TEE) will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using the RIA device.
11999739|NCT00594438|Device|Zimmer Sentinel Reamer|A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram TEE will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using either a conventional reaming technique or the RIA device.
11999740|NCT00594425|Drug|Methyl aminolevulinate (MAL) PDT|Cream application followed by illumination with red light
11999741|NCT00594412|Procedure|Diagnostic Radiology: 1H-MRS of the liver|
11999742|NCT00594399|Behavioral|Physical Activity Counseling|Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback.
11999743|NCT00594386|Drug|Rotigotine|"Rotigotine transdermal patches:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
~Optimal dosing:
~During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours.
~After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours."
11999744|NCT00594373|Drug|Tenofovir gel|1 gm/100 ml of 1% tenofovir gel vaginally daily
11999745|NCT00594373|Drug|Tenofovir gel placebo|1 gm/100 ml of placebo gel vaginally daily
11999746|NCT00594360|Behavioral|Exercise on Prescription|Exercise two times a week for two months at a physiotherapist. Afterwards exercise one time a week at a physiotherapist and self-contained training one time a week for 2 months.
11999747|NCT00594347|Biological|Pneumo 23|Vaccine (Pneumo 23)
11999748|NCT00594347|Biological|Prevnar|Vaccine (Prevnar)
11999749|NCT00594334|Drug|Risedronate|Weekly Risedronate
11999750|NCT00594321|Device|SPACE CpsXL Bone Cement and SPACE 360 Delivery System|SPACE CpsXL Bone Cement and SPACE 360 Delivery System
11999751|NCT00594321|Device|standard vertebroplasty|standard vertebroplasty
11999752|NCT00594308|Drug|Cyclophosphamide|60mg/kg/day for two consecutive days (-7,-6).
11999753|NCT00594308|Drug|Fludarabine|25mg/m2/day for 5 consecutive days
11999754|NCT00594308|Drug|Cyclosporine|3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
11999755|NCT00594308|Drug|Mycophenolate mofetil|1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
11999756|NCT00594308|Drug|Basiliximab|20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.
11999757|NCT00594282|Device|Radiolucent cushion|MammoPad radiolucent breast plate cushion used during mammogram
11999758|NCT00594269|Drug|Risperidone|Discontinuation
11999759|NCT00594269|Drug|Escitalopram|Discontinuation
11999760|NCT00594269|Drug|Citalopram|Discontinuation
11999761|NCT00594269|Drug|Sertraline|Discontinuation
11999762|NCT00594269|Drug|Paroxetine|Discontinuation
11999763|NCT00594256|Drug|Sodium Oxybate|Patients will undergo a one-week evaluation period, which will include a taper and discontinuation of any currently prescribed sedative/hypnotics, as well as baseline diagnostic, psychopathology, neurocognitive and polysomnographic measurements (see below for details). Hypnotic taper may be extended or abbreviated, depending on clinical judgment. Patients will then begin a 4-week trial of adjunctive Xyrem (sodium oxybate). Patients will begin at 4.5 g/night (in divided doses of 2.25 g, with 1st dose at bedtime and then 2nd dose four hours later). Dosage will increase by 1.5 g/day every week, until a dose of 9 g nightly is reached, or a patient cannot tolerate further dose escalations. Medication will be administered in divided dosage for the duration of the study. A three-week taper (by 3 g/day weekly) of sodium oxybate will follow the four-week trial of sodium oxybate.
11999764|NCT00594243|Behavioral|Mindfulness based stress reduction program|8-week mindfulness based stress reduction program
11999765|NCT00594243|Other|Wait-list control|No treatment given.
11999766|NCT00594230|Drug|Panobinostat|Panobinostat(20 mg or 30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
11999767|NCT00594217|Drug|oral micronized progesterone suspension|oral micronized progesterone suspension, single 100 mg oral dose
11999771|NCT00594191|Drug|Simvastatin|20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met
11999772|NCT00594191|Drug|Placebo|Placebo with the same characteristics of the drug and at the same dose
11999773|NCT00594178|Device|Motorized bicycle exercise training|Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months
11999774|NCT00594165|Drug|Rotigotine|"Rotigotine trans-dermal patches:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
~Optimal dosing:
~During the first year:
~The maximum Rotigotine dose allowed is 6 mg/24 hours.
~After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours."
11999775|NCT00594152|Drug|CIIIT|The intravenous infusion group received three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to subcutaneous insulin.
11999776|NCT00594139|Biological|Autologous neobladder construct|provision of an autologous neo-bladder construct
11999777|NCT00594126|Drug|Imetelstat Sodium (GRN163L)|25% dose escalation infused over 2 hours weekly
11999778|NCT00594113|Other|Touch 2 Screen|"Multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of implementation intentions, an advanced planning model taken from the Theory of Planned Behavior"
11999779|NCT00594113|Other|Touch screen intervention|Touch screen intervention
11999780|NCT00594100|Device|GORE Flow Reversal System (GFRS)|Carotid artery angioplasty and stenting with embolic protection
11999781|NCT00594087|Drug|eszopiclone|eszopiclone 2mg or 3mg at bedtime
11999782|NCT00594087|Other|placebo|2 mg or 3 mg at bedtime
11999783|NCT00594074|Other|white wine|3.25 ounces of white wine twice a day with lunch and dinner
11999784|NCT00594061|Device|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.
11999785|NCT00594048|Device|Resperate|Use of the device 15 minutes a day for 9 weeks
11999786|NCT00594048|Device|discman with freely chosen music|Use the discman 15 minutes a day for 9 weeks
11999787|NCT00594035|Device|Spinal Sealant System|
11999788|NCT00594035|Device|Standard of care|Standard of care: devices intended to provide a watertight closure
11999789|NCT00594022|Device|"Electric stimulation of the Vestibular Nerve - VirtuSom"|This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes.
11999790|NCT00594022|Device|"Electric stim of the Vestibular Nerve - VirtuSom - SHAM"|This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only.
11999791|NCT00594009|Device|Venovenous CO2 Removal (VVCO2R) in COPD|Patients who meet criteria will be placed on an extracorporeal circuit consisting of an oxygenator, centrifugal pump, tubing and indwelling double lumen venous catheter for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care
11999792|NCT00593996|Other|Ergocalciferol (vitamin D2)|50,000 IU 3 times weekly for 4 weeks
11999793|NCT00593983|Behavioral|Peer-driven intervention|Consists of four structured intervention sessions lasting 6 hours in total, three peer education/recruitment experiences, and brief liaison contacts by an intervention facilitator during AIDS clinical trial screening
11999794|NCT00593983|Behavioral|Time-matched health education|Health education and standard of care treatment
11999795|NCT00593957|Drug|Dextromethorphan|Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial.
11999796|NCT00593957|Drug|Dextromethorphan|Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
11999797|NCT00593944|Biological|MDX-1342|MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.
11999798|NCT00593931|Other|fMRI|Functional Magnetic Resonance Imaging without contrast
11999799|NCT00593905|Drug|Sitaxsentan|Sitaxsentan sodium 100 mg tablet every morning
11999800|NCT00593905|Drug|Bosentan, Ambrisentan|Bosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily
11999801|NCT00593879|Drug|Mecamylamine|2.5mg mecamylamine Hcl, tablet form taken twice a day (total of 5.0mg). For 7.5 mg dose group, 2 tablets taken morning, one tablet evening. At 10.0mg, 2 tablets taken twice daily.
11999802|NCT00593866|Radiation|INTENSITY MODULATED RADIOTHERAPY|Five fractions weekly, fraction size determined by dose level
11999803|NCT00593866|Drug|Gemcitabine|1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
11999804|NCT00593853|Drug|Methylphenidate Hydrochloride|Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
11999805|NCT00593853|Drug|Matched Placebo|Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
11999806|NCT00593840|Radiation|Intensity modulated radiation therapy|
11999807|NCT00593827|Drug|Ixabepilone|Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
11999808|NCT00593827|Drug|Ixabepilone|Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
11999809|NCT00593814|Device|GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability|Implant
11999810|NCT00593801|Drug|epoetin beta|250 IU/kg/week rhEPO treatment subcutaneously 3 times a week from the first week for 9 weeks, all infants received enteral iron 3-9 mg/kg/day
11999811|NCT00593801|Drug|epoetin beta|250 IU/kg/week subcutaneously 3 times a week, from the fourth week for 6 weeks, all infants received enteral iron 3-9 mg/kg/day
11999812|NCT00593775|Procedure|assisted hatching|assisted hatching with laser
11999813|NCT00593749|Behavioral|Healthy Corner Store Initiative|modification of snacks and beverages offered in corner store surrounding 10 schools
11999814|NCT00593749|Behavioral|Control|control group in study
11999815|NCT00593736|Drug|Ramelteon|Ramelteon 1 mg, tablets, orally, once daily for up to two weeks.
11999816|NCT00593736|Drug|Ramelteon|Ramelteon 4 mg, tablets, orally, once daily for up to two weeks.
11999817|NCT00593736|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily for up to two weeks.
11999818|NCT00593736|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.
11999819|NCT00593723|Radiation|IMRT|
11999820|NCT00593710|Drug|Losartan|Losartan (25mg OD)
11999821|NCT00593710|Drug|Atenolol|Atenolol (25-50mg OD)
11999822|NCT00593697|Drug|trastuzumab (9 weeks) + docetaxel|"Patients diagnosed with early breast cancer with a high risk of disease recurrence will be randomly allocated to one of the following 2 arms in a 1:1 ratio:
~A. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) (HT x3 ->FE75C x3) B. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)"
11999823|NCT00593697|Drug|trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)|Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)
11999824|NCT00593684|Device|Silver Alginate|This is a sterile patch of polyurethane foam coated with silver alginate and maltodextrin matrix that is impregnated with 141 mg of ionic silver per 100 cm2.
11999825|NCT00593671|Procedure|Preimplantation genetic screening after embryo biopsy|Preimplantation genetic screening after embryo biopsy
11999826|NCT00593658|Drug|pentoxifylline|pentoxifylline extended release 800mg PO TID for 8 weeks
11999827|NCT00593645|Drug|Clofarabine|
11999828|NCT00593645|Drug|Cytarabine|
11999829|NCT00593645|Drug|Thymoglobulin|
11999830|NCT00593645|Procedure|Stem cell infusion|
11999831|NCT00593632|Dietary Supplement|Uncle Sam Cereal|two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet
11999832|NCT00593619|Drug|Iron dextran|300mg in 250cc normal saline given over 2 hours
11999833|NCT00593619|Drug|Iron sucrose|300mg in 250cc normal saline given over 2 hours
11999834|NCT00593606|Drug|Rotigotine|Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
11999835|NCT00593580|Drug|placebo|placebo
11999836|NCT00593580|Drug|alendronate/cholecalciferol|FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration
11999837|NCT00593567|Drug|gentamicin-collagen sponge|Inserted daily into open ulcer
11999838|NCT00593567|Drug|Levofloxacin|750mg oral levofloxacin daily
11999839|NCT00593554|Radiation|Total Body Irradiation|8 Gy on Day -9
11999840|NCT00593554|Drug|Thiotepa|5 mg/kg/d on Day -8 to -7
11999841|NCT00593554|Drug|Fludarabine|40 mg/m2/d on Day -6 to -3
11999842|NCT00593554|Biological|Rabbit ATG|2.5 mg/kg/d on Day -5 to -2
11999843|NCT00593554|Drug|Palifermin|60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
11999844|NCT00593528|Device|Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)|Vascular Stents
11999845|NCT00593528|Device|PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)|Vascular Stents
11999846|NCT00593528|Procedure|Transjugular intrahepatic portosystemic shunt (TIPS)|Transjugular intrahepatic portosystemic shunt (TIPS)
11999847|NCT00593515|Behavioral|Family cognitive behavioral therapy|12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each
11999848|NCT00593515|Behavioral|Child-focused cognitive behavioral therapy|12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each
11999849|NCT00593502|Drug|oseltamivir|Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; > 40 kg, 75 mg twice daily, for 5 days
11999850|NCT00593502|Drug|placebo|The dosage of placebo will be similar to the active drug
11999851|NCT00593489|Other|Basal Insulin Initiation Strategy|This multifaceted intervention consists of (1) Diabetes Specialist Consultation Support which entails specialists and educators providing consultation for insulin initiation and titration for the 12 months following the Workshop. Support will consist of prearranged and scheduled communications to review and advise for the first 2 months and will continue on an ad hoc basis for the remaining 10 months, with communication initiated by the physician (2)Community Pharmacy Insulin Initiation consists of trained community pharmacists providing patient education insulin initiation. Education will consist of one individual teaching session, one hour in duration, to review the insulin prescription protocol, insulin injection method, management of hypoglycemia, and self-monitoring of blood glucose.
11999852|NCT00593476|Other|PCD|pre-packaged, portion-controlled (PCD) meal plan for 24 weeks
11999853|NCT00593476|Other|DSE|12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24
11999854|NCT00593463|Drug|Cycloserine|Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
11999855|NCT00593463|Drug|Diltiazem|Diltiazem: 30, 60, 120 mg oral capsule may possibly be
11999856|NCT00593463|Drug|Gabapentin|Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
11999857|NCT00593463|Drug|Isradipine|Isradipine: 5, 10 mg oral capsule may possibly be given
11999858|NCT00593463|Drug|Naloxone|Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
11999859|NCT00593463|Drug|Nifedipine|Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
11999860|NCT00593463|Drug|Placebo|Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given
11999861|NCT00593463|Device|Saline|Saline: I.M. injection may possibly be given
11999862|NCT00593463|Drug|Verapamil|Verapamil: 30, 60, 120 mg oral capsule may possibly be given
11999863|NCT00593450|Drug|ranibizumab|• 0.5 mg (0.05 mL)intravitreal injection
11999866|NCT00593424|Other|High Monounsaturated Fat/Low Carbohydrate|High Monounsaturated Fat/Low Carbohydrate for 6 week period
11999867|NCT00593385|Device|iCAST covered stent|Iliac stent implantation
11999868|NCT00593372|Behavioral|Spaced Retrieval Training|Increasing time to remember important information.
11999869|NCT00593346|Radiation|brachytherapy|brachytherapy (radioactive implants)
11999870|NCT00593333|Device|Antegrade Intramedullary Nail|Use of an antegrade intramedullary nail implanted through the Piriformis fossa of the femur. The use of these nails has yielded a union rate of 97 - 99%, and has clearly become the most commonly utilized implant for femur fractures.
11999871|NCT00593333|Device|Trigen Trochanteric Femoral Nail|Antegrade intramedullary nails developed with a proximal lateral bend that allows implantation through the greater trochanter rather than the piriformis fossa. This start portal is remarkably easier to locate and may be associated with decreased risk of abductor muscle weakness and pain.
11999872|NCT00593320|Radiation|Stereotactic Radiosurgery|
11999873|NCT00593307|Other|high GI|high GI and high carb breakfast
11999874|NCT00593307|Other|Low GI|low GI, high carb breakfast
11999875|NCT00593307|Other|Low GI Low Carb|low GI low carb breakfast
11999876|NCT00593307|Other|High GI Low carb|high GI low carb breakfast
11999877|NCT00593294|Behavioral|Physical exercise|45 minutes each day for three times/week for 6 months
11999878|NCT00593294|Drug|OC - Drospirenone plus Ethynylestradiol|1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy)
11999879|NCT00593294|Dietary Supplement|Vitamin, polyvitamins tablets|Tablet of vitamin 1cp for 21 days each month for 6 months
11999880|NCT00593281|Drug|Hylenex|Add Hylenex to SC injection of Morphine
11999881|NCT00593255|Drug|soluble human insulin|
11999882|NCT00593255|Drug|insulin aspart|
11999883|NCT00593255|Drug|insulin NPH|
11999884|NCT00593242|Biological|infusion of autologous cord blood|infants who meet study enrollment criteria for history of moderate to severe hypoxic ischemic encephalopathy in the neonatal period will receive up to 4 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells. The dose for each infusion is 5x10e7 cells/kg
11999885|NCT00593242|Other|Neurodevelopmental outcomes|historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood
11999886|NCT00593216|Device|Functional MRI imaging|The functional MRI imaging of whole brain will be obtained before, during and after the vestibular response which is induced by the designated caloric stimulation. Post-imaging analysis will reveal which region or neural pathways in the central nervous system may attributed to the development of vertigo.
11999887|NCT00593190|Drug|Gas SF6 (Sulfur Hexafluoride)|ONCE
11999888|NCT00593177|Drug|PTH (1-34) Gel / Placebo Gel|Topical dosing of gel twice daily for eight weeks.
11999889|NCT00593164|Device|Cooling with ThermoSuit with Magnesium Sulfate Infusion|Cooling with LRS ThermoSuit within 15 minutes of intravenous Magnesium Sulfate infusion (30 mg/kg, added to 100 ml normal NaCl solution, given over 15 min).
11999890|NCT00593164|Device|Cooling with ThermoSuit with Normal Saline Infusion|Cooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min).
11999891|NCT00593151|Other|Locteron (controlled-release interferon alpha 2b)|biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection
11999892|NCT00593151|Biological|pegylated IFNa2b|biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg
11999893|NCT00593138|Drug|dex-methylphenidate|The drug is administered as a capsule by mouth. Participants are assigned to receive either 20, 30 or 40 mg doses before each scan visit.
11999894|NCT00593125|Drug|levetiracetam|The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will not be blind to the subject's medication administration. The medication will be discontinued over a two-week period
11999895|NCT00593112|Drug|OROS methylphenidate|Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.
11999896|NCT00593112|Other|No intervention|No intervention
11999897|NCT00593099|Drug|Bupropion|BUP [as the intermediate-release (IR) formulation] was inducted on Day 1 of the trial at 75 mg po qd x 3 days, then increased to 150 mg [as BUP SR formulation] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (target quit date; TQD) as tolerated. This dose was continued for an additional eight (8) weeks at up to 150 mg po bid. Flexible dosing was permitted to allow for adjustments needed if a bipolar subject did not tolerate the full dose of BUP at 300 mg/day. BUP was discontinued at the end of Week 10.
11999898|NCT00593099|Drug|Placebo|matching placebo capsules (PLA) containing only a dextrose matrix.
11999899|NCT00593086|Procedure|Pain management|Pain mamagement for burn care procedures.
11999900|NCT00593086|Other|Standard of care/no virtual reality game|no intervention for standard of care
11999901|NCT00593073|Behavioral|Electronic tailored messaging|Tailored CRC message based on patient screening barriers, preferences and attitudes and reminder to get screened.
11999902|NCT00593073|Behavioral|General Reminder Message|General CRC health education message and reminder to get screened.
11999903|NCT00593060|Drug|Temsirolimus|Given intravenously every week of each 28-day cycle (days 1, 7, 15, 22). Participants can continue to receive study treatment as long at their tumor is responding.
11999904|NCT00593060|Drug|Cetuximab|One dose is given intravenously 7 days prior to the start of each 28-day cycle, then it is given every week (along with temsirolimus)of each 28-day cycle (on days 1, 7, 15, 22). Participants can continue to receive study treatment as long at their tumor is responding.
11999905|NCT00593047|Drug|KB2115|tablet formulation given once daily for 12 weeks
11999906|NCT00593008|Drug|Temsirolimus|Given intravenously every week of each 28-day cycle (days 1, 8, 15 and 22). Participants may continue to receive study treatment as long as their tumor is responding and they don't experience any serious side effects.
11999907|NCT00593008|Drug|Gemcitabine|Given intravenously every other week of each 28-day cycle.
11999908|NCT00592995|Drug|Creatine monohydrate|10 to 30 grams daily
11999909|NCT00592995|Drug|Placebo|10 to 30 grams daily
11999910|NCT00592969|Drug|metformin|
11999911|NCT00592969|Drug|biphasic insulin aspart|
11999912|NCT00592943|Drug|armodafinil|tablet, taken by mouth, once each study day
11999913|NCT00592930|Drug|olanzapine|flexibly dosed oral olanzapine 2.5 to 15 mg/day
11999914|NCT00592930|Drug|placebo|
11999915|NCT00592917|Dietary Supplement|calcium carbonate and cholecalciferol|one tablet (calcium carbonate resembling 500 mg of calcium and 400 IU or 5 micrograms of vitamin-D3, cholecalciferol) twice daily for the whole duration of the study
11999916|NCT00592904|Drug|E2007|Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).
11999917|NCT00592891|Drug|Hyperbaric oxygen therapy|Total body pressurized oxygen
11999918|NCT00592852|Drug|fluoxetine|capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
11999919|NCT00592839|Drug|SCE-B|0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
11999920|NCT00592839|Drug|Placebo|Matching placebo for 0.3 mg and 0.625 mg tablets
11999921|NCT00592813|Behavioral|Enhanced Strong for Life|"The program contains 5 minutes of warm-up, 25 minutes of strengthening, and 5 minutes of cool-down exercises. The SFL program is contained on a 35 minute videotape. Subjects are instructed to increase resistance when they can perform 10 repetitions of a movement pattern without significant fatigue or loss of proper execution. Subjects are instructed to move within a comfortable range of motion.
~Participants will be taught the SFL program during two home visits conducted by a physical therapist. On the first visit, the exercise techniques will be taught, modified as needed based on individual needs and practiced as necessary until proper technique is attained. Each participant will be given written guidelines for how to progress resistance of the program, how to modify the exercises and how to complete bimonthly exercise calendars."
11999922|NCT00592813|Behavioral|cardiovascular nutrition education|administered as an attention control intervention using home visits, phone calls and mail-outs of information
11999923|NCT00592774|Drug|E2007 (perampanel)|2 mg titrated up to 8 mg maximum; taken once daily.
11999924|NCT00592774|Drug|Placebo|2 mg titrated up to 8 mg maximum; taken once daily.
11999925|NCT00592761|Behavioral|Mendelsohn Maneuver|Mendelsohn Maneuver with Surface Electromyography
11999926|NCT00592748|Radiation|Charged Particle Radiation Therapy|Radiation doses will be determined by planning CT
11999927|NCT00592735|Procedure|laparoscopic gastric banding|standard surgical procedure
11999928|NCT00592683|Drug|Aripiprazole|tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks
11999929|NCT00592683|Dietary Supplement|fish oil|1600mg (4 capsules) daily for 12 weeks
11999930|NCT00592683|Drug|Placebo|Placebo
11999931|NCT00592670|Drug|Fluoxetine|20 mg fluoxetine orally one per day for 1 week, 40 mg fluoxetine orally once per day for one week, 80 mg Fluoxetine orally for remaining 4 weeks of treatment
11999932|NCT00592670|Drug|Placebo|20 mg placebo pill taken orally once per day for one week, 40 mg placebo pill taken orally one per day for one week, 80 mg placebo pill taken orally once per day for remaining 4 weeks.
11999933|NCT00592644|Procedure|Pulse Dye laser (PDL)|one-time PDL, in 10 subjects
11999934|NCT00592644|Procedure|CO2 laser or other traditional surgeries|once-time CO2 laser or other conventional surgeries, in other 10 subjects
11999935|NCT00592631|Device|CPAP-Continuous Positive Airway Pressure|Cpap will be worn at night by subjects 6 to 7 days duration.
11999936|NCT00592631|Device|SHAM|SHAM will be worn at night by subjects 6 to 7 days duration.
11999937|NCT00592618|Drug|Oral N-Acetylcysteine 1200 mg x 2/day for 4 weeks|
11999938|NCT00592592|Radiation|Proton Beam Radiation|Once per day, 5 days a week for a total of 4 to 6 weeks.
11999939|NCT00592579|Drug|2-methoxyestradiol|800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
11999940|NCT00592566|Drug|Dexamethasone, desmopressin|200 mg of dexamethasone IV infusion OD for 3 days or 0.3 microgram/ kg of desmopressin in 50 ml of saline, as a 30- minute infusion
11999941|NCT00592553|Drug|Ataluren|Ataluren will be administered as per the dose and schedule specified in the respective arms.
11999942|NCT00592553|Drug|Placebo|Placebo matching to ataluren will be administered as the schedule specified in the respective arm.
11999943|NCT00592540|Procedure|Unrelated Donor BMT|Unrelated donor bone marrow transplantation has not been performed with these patients in the past
11999944|NCT00592527|Drug|insulin detemir|
11999945|NCT00592501|Radiation|Proton/Photon Radiotherapy|Given once a day, five days a week, for seven weeks.
11999946|NCT00592501|Drug|Cisplatin|Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.
11999947|NCT00592501|Drug|Fluorouracil|Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.
11999948|NCT00592488|Drug|Acetyl-L-Carnitine|Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
11999949|NCT00592475|Drug|conivaptan|IV
11999950|NCT00592475|Drug|Placebo|IV
11999951|NCT00592462|Procedure|Whole Body MRI|The whole body MRI will include T1-weighted and T2-weighted phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in multiple patient table stations.
11999952|NCT00592449|Behavioral|Cognitive behavioral therapy (CBT) for insomnia|During CBT, participants will learn how to change their sleeping habits and reduce arousal and alertness while trying to sleep. Participants will attend 8 weekly CBT sessions with a psychologist.
11999953|NCT00592449|Behavioral|Behavioral desensitization treatment for insomnia|The behavioral desensitization treatment is designed to decondition states of arousal that interfere with sleep. Participants will attend 8 weekly behavioral desensitization treatment sessions with a psychologist.
11999954|NCT00592423|Other|Continuous Positive Airway Pressure during MRI|10 cm H20 pressure for CPAP while lateral neck positioning is done for MRI - each side should take 5 minutes.
11999955|NCT00592410|Drug|human regular insulin|administration of a primed continuous infusion of human regular insulin at a rate of 2.0 mU/kg/min while maintaining the plasma glucose level at 100 mg/dl via adjusting a variable infusion of 50% dextrose (i.e., a hyperinsulinemic euglycemic blood glucose clamp); duration of 3 hours; performed concomitantly with amino acid supplementation
11999956|NCT00592397|Other|Balanced macronutrient diet intervention|Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.
11999957|NCT00592384|Drug|venlafaxine XR|Once daily oral dose of venlafaxine XR ranging from 37.5 mg up to 300 mg
11999958|NCT00592384|Drug|placebo|Once daily oral dose of placebo ranging from 37.5 mg up to 300 mg
11999959|NCT00592358|Drug|paliperidone|tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks
11999960|NCT00592345|Radiation|Proton Beam Radiation|Administered over a period of 12 weeks.
11999961|NCT00592345|Radiation|Photon Beam Radiation|Administered over a period of 12 weeks.
11999962|NCT00592345|Radiation|Interoperative radiation|Radioactive plaque applied at the time of surgical removal of the tumor.
11999963|NCT00592332|Drug|Alprazolam|1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
11999964|NCT00592332|Other|control group|control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.
11999965|NCT00592319|Drug|Celebrex|oral taking of Celebrex (100 mg, BID) for 9 months
11999966|NCT00592319|Device|PDL|once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
11999967|NCT00592319|Procedure|CO2 laser or microsurgery|once-time surgery to remove laryngeal papilloma
11999968|NCT00592306|Drug|thymoglobulin (intraoperative)|"All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered.
~Each arm will also receive a single placebo dose.
~Arm I will receive thymoglobulin intraoperatively followed by a postoperative placebo dose and two subsequent thymoglobulin doses."
11999969|NCT00592306|Drug|thymoglobulin (postoperative)|"All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered.
~Each arm will also receive a single placebo dose.
~Arm II will receive placebo intraoperatively followed by 3 postoperative doses of thymoglobulin."
11999970|NCT00592293|Radiation|Proton Beam Radiation|Once per day, 5 days a week for a total of 4 to 6 weeks.
11999971|NCT00592280|Device|Two-Layer Method pancreas preservation system|Preserving the pancreas before transplantation in an oxygenated system containing highly oxygenated liquid perfluorocarbon (perfluorodecalin, C10F18. The perfluorocarbon combines low toxicity with a capacity to dissolve 75 times more oxygen than the UW solution used in standard pancreas storage. When preserved under these conditions, the pancreas absorbs oxygen by diffusion and steadily consumes it, supporting sufficient aerobic metabolism to maintain tissue ATP concentrations at near-physiologic levels and prevent, or even reverse, pancreas anoxic injury.
11999972|NCT00592241|Device|"Adi Insulin Pump Usability"|no intervention
11999973|NCT00592228|Device|Cypher, Taxus or Endeavor|"percutaneous drug-eluting stent implantation,
~FFR group: if FFR<0.75
~Routine DES group"
11999974|NCT00592215|Drug|Experimental (mifepristone and misoprostol)|Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours
11999975|NCT00592202|Device|Placement of an adjustable gastric band|Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.
11999976|NCT00592189|Procedure|blood draw|blood collection
11999977|NCT00592176|Drug|local injection of bevacizumab|Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. All injections of bevacizumab will consist of injecting 0.1mL of a 2.5mg/0.1mL concentration of bevacizumab into the head of the pterygium.
11999978|NCT00592163|Drug|ZIO-101-C (Darinaparsin)|Dose Escalation study, 200 mg - 900 mg, cumulative daily dose split to be taken BID 7 times a week (>8 hours between doses) for 3 weeks followed by 1 week of rest
11999979|NCT00592150|Drug|fenoldopam|The fenoldopam infusion rate will be 0.05 μg/kg/min for 3 hours
11999980|NCT00592150|Drug|Placebo|Placebo infusion for 3 hours
11999981|NCT00592137|Dietary Supplement|C (smoothies based on soy protein containing no additional calcium)|Two smoothies per day based on soy protein containing no additional calcium
11999982|NCT00592137|Dietary Supplement|B (smoothies based on soy protein containing calcium)|Two smoothies daily based on soy protein containing 650 mg calcium as calcium carbonate
11999983|NCT00592137|Dietary Supplement|A (smoothies based on dairy protein containing calcium)|Two smoothies daily based on dairy protein containing 650 mg calcium
11999984|NCT00592124|Drug|Tenofovir disoproxil fumarate|300 mg tablet daily
11999985|NCT00592124|Drug|Tenofovir gel|1 gm/100 ml of 1% gel vaginally daily
11999986|NCT00592111|Drug|COPP/ABV|4 courses of COPP/ABV hybrid
11999987|NCT00592111|Drug|COPP/ABV|6 courses of COPP/ABV hybrid
11999988|NCT00592111|Drug|intensive chemo with concurrent growth factor|6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor
11999989|NCT00592098|Drug|Strontium chloride hexahydrate|Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
11999990|NCT00592098|Drug|Placebo|Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
11999991|NCT00592085|Behavioral|Questionnaires|Participants will use a computer to complete a series of questionnaires.
11999992|NCT00592085|Behavioral|Motivational Relapse Prevention Counseling|Total of 6 counseling calls for Smoking Relapse: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
11999993|NCT00592085|Behavioral|Relapse Plus Alcohol Risk Reduction Counseling|Total of 6 counseling calls for both Smoking Relapse and Alcohol Risk: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
11999994|NCT00592072|Dietary Supplement|Medium chain fatty acid (Octanoic and Decanoic acid)|Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.
11999995|NCT00592072|Other|Splenda (Placebo Control)|Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor.
12000212|NCT00590174|Drug|Aspirin,Clopidogrel|continue aspirin and clopidogrel 1year after DES
11999996|NCT00592046|Drug|ZIO-101 (Darinaparsin)|ZIO-101 (Darinaparsin) given for five consecutive days to be repeated every 28 days for up to six months. This is a dose escalation study.
11999997|NCT00592033|Other|oxygen from a portable concentrator|2 l/minute during exercise
11999998|NCT00592020|Procedure|Short Transverse Incision|Short Transverse Incision for kidney transplantation
11999999|NCT00592020|Procedure|Hockey Stick Incision|Hockey Stick Incision for kidney transplantation
12000000|NCT00592007|Drug|Fulvestrant and Erlotinib|Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
12000001|NCT00591994|Drug|piribedil|50 mg once a day, after lunch 3 month therapy
12000002|NCT00591981|Behavioral|TOGA Tools|ADL's, Zubrod, IADL's, BFI, MMS, MNS, GDS
12000003|NCT00591968|Device|SonoSite Titan portable ultrasound coupled with email telediagnosis|"Sonographic exam will be performed by principal investigator. A first-look diagnosis, correlated with patient symptomology and laboratory analysis, will be made at the point of care. Using a store-and-forward framework, properly formatted non-compressed sonographic images and Request for Interpretation (RFI) forms will be transmitted to participating radiologists. RFI forms will be used to record diagnostic findings and rate the quality of the images and/or diagnostic value using a five-point Likert scale. RFI forms will also include a five-digit patient number, age, sex, and symptomology / reason for sonographic exam. Completed RFI forms will be transmitted back to the clinic at the radiologist's earliest convenience."
12000004|NCT00591942|Device|Full ceramic crowns or 3-unit fixed partial dentures.|Subjects who met the inclusion/excluson criteria received two ceramic crowns or one three-unit dental bridge on posterior teeth. The crowns and dental bridge were cemented using two different dental adhesives. Follow-up to assess sensitivity of the crowns/bridges occur at 24 hrs. and 1 week post seating by telephone. Clinical visits to assess sensitivity and the integrity of the crowns/bridges occur at 6, 12, 18 and 24 months post seating of the restorations.
12000005|NCT00591929|Other|Continuous Passive Motion|at least 48 hours of continuous passive motion following ORIF of fractures around the knee
12000006|NCT00591916|Drug|Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]|Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT).
12000007|NCT00591916|Procedure|Blood sample|Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
12000008|NCT00591916|Procedure|Biopsy|Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
12000009|NCT00591890|Drug|indibulin|dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days.
12000010|NCT00591877|Procedure|Acupuncture|"Each patient will undergo a 30 minute session, twice a week, for a total of 12 sessions. The technique will involve electro-stimulation at predefined points followed by needle manipulation.
~The acupoints that will be used are:
~ST-36: 3 finger breadths inferior to lower edge of patella between tibialis anterior muscle and the tibia, 1 finger breadth lateral to the anterior crest of the tibia.
~PC-6: 2 finger breadths proximal to and in the middle of the most distal transverse crease of the wrist, between the tendons of palmaris longus and flexor carpi radialis.
~CV-12: 4 finger breadths superior to the umbilicus."
12000011|NCT00591877|Procedure|Sham Acupuncture|"The acupoints for SAC are:
~LI-4 : adjacent to and at the middle of the radial side of the 2nd metacarpal bone, at the same level as the end of the crease when the thumb and index fingers approximate.
~GB-32: on the lateral aspect of the thigh 5 finger breadths proximal to the popliteal crease, 2 finger breadths inferior to GB31.
~UB -15: 1.5 finger breadths lateral to the midline of the spine on a level between the 5 th and the 6 th thoracic vertebrae."
12000012|NCT00591877|Other|Yoga|The participants in this arm will undergo a 60 min session of yoga exercises. These exercises are specifically designed for reflux symptoms by a yoga instructor. This includes a set of specific physical postures (asana) and breathing techniques within the four-element setup. The set of asana are divided into (a) standing, (b) sitting, and (c) lying down positions. The session will begin with asana in standing position, followed by a position called Shavasan (relaxation), then asana in sitting down position followed by Shavasan, finally asana in lying down position followed by Shavasan. At the end of all asana, Pranayam (special breathing exercises) will be practiced.
12000013|NCT00591864|Device|Molecular Breast Imaging|Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
12000014|NCT00591851|Drug|AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)|No Intervention
12000015|NCT00591838|Radiation|Stereotactic Body Radiation Therapy (SBRT)|
12000016|NCT00591825|Drug|D-cycloserine|D-cycloserine
12000017|NCT00591825|Drug|Placebo|Placebo
12000018|NCT00591812|Device|ComPreSs Distal Femoral Replacement System.|ComPreSs system of intramedullary fixation along with the Finn Knee system
12000019|NCT00591799|Device|The Jarvik 2000 Ventricular Assist System|Jarvik 2000 Heart implantation is intended for patient's with end-stage heart failure who are approved heart transplant candidates - who meet all of the study's inclusion criteria and none of its exclusion criteria.
12000020|NCT00591786|Drug|Sugammadex|After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.
12000021|NCT00591773|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 40 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily; and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
12000022|NCT00591773|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 80 mg, tablets, orally, once daily; azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
12000213|NCT00590161|Drug|pentoxifylline (PTX)|400 mg PO tid
12000023|NCT00591773|Drug|Chlorthalidone|Chlorthalidone 25 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily and azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
12000024|NCT00591760|Drug|Somatotropin|Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
12000025|NCT00591747|Behavioral|Resistance Exercise|60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
12000026|NCT00591747|Behavioral|Flexibility Training|60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
12000027|NCT00591734|Drug|Bevacizumab|15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
12000028|NCT00591734|Drug|Everolimus|10 mg by mouth daily
12000029|NCT00591721|Behavioral|Energy conservation education|The intervention for this study is a group-based educational program delivered by teleconference to 4-6 individuals with MS by a licensed occupational therapist. The program involves 6 weekly sessions. Each session is 1 hour and 15 minutes in duration. Key topics addressed include: importance of rest, positive and effective communication, modification of the environment, using equipment and technology, setting priorities, and activity analysis and modification. Direct instruction, group discussion, and peer support are key elements of the program. Participants receive a manual with application activities that are completed in between sessions.
12000030|NCT00591708|Dietary Supplement|Beverage containing calcium citrate malate|Beverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
12000031|NCT00591708|Dietary Supplement|Beverage fortified with calcium citrate malate|Beverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
12000032|NCT00591695|Procedure|Stent bridge to surgery + elective surgery|positioning in emergency of a metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour
12000033|NCT00591695|Procedure|Emergency Surgery|Emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy
12000034|NCT00591682|Drug|MSX-122|"Dosage form = capsule
~Starting Dose (First Patient Cohort - Dose Level 1) = 50 mg taken orally once daily, 7 days per week for 4 weeks (total of 28 days), followed immediately by a second course of 28 days with identical dosage form and schedule. (Each patient in each cohort treated for a minimum of 56 days, unless obviated by toxicity.)
~If there is no evidence of toxicity at the current dose level, then the dose of MSX-122 will be increased by 100% for the next patient cohort.
~If a grade 1-2 toxicity is observed, then the dose will be increased by 50% for the next patient cohort.
~If a grade 3 toxicity (non-dose limiting toxicity) is observed then the dose will be increased by 25% for the next patient cohort."
12000035|NCT00591669|Other|Definity|We will be placing one vial (1.3) of Definity® in 50 mL of preservative-free saline. Our infusions will be initiated at slightly lower than recommended starting rate (3mL/min) and will be adjusted as necessary to produce optimal enhancement. The rate will not exceed 10 ml/min and we will not give more than 1.3 mL of Definity® in 50mL saline in any 24-hour period.
12000036|NCT00591669|Other|Definity|We will be placing one vial (1.3) of Definity® in 50 mL of preservative-free saline. Our infusions will be initiated at slightly lower than recommended starting rate (3mL/min) and will be adjusted as necessary to produce optimal enhancement. The rate will not exceed 10 ml/min and we will not give more than 1.3 mL of Definity® in 50mL saline in any 24-hour period.
12000037|NCT00591643|Procedure|Imaging, Adrenal acans|The patient will be given 5 drops of saturated solution of potassium iodide daily for 2 days prior to the study and will continue for 5 to 7 days later to minimize the radiation dose to the thyroid gland. One to 2 mCi of I 131 1,6-beta-iodomethyl-19-norcholesterol (NP-59) in 10% ethanol, 0.23% polysorbate 80 and 0.9% NaCl will be given intravenously slowly over 1-5 minutes. Anterior and posterior images of the adrenal area will be obtained 72 and 96 hours later. Additional images will be made if indicated. Each image would require 30 minutes carried out in the nuclear medicine laboratory. To verify the exact location of the adrenal glands, renal scan with 99m Tc DTPA or Mag 3 (routine nuclear medicine radiopharmaceuticals) will also be obtained whenever indicated. In some patients, dexamethasone suppression will be carried out to improve the specificity of NP 59 diagnosis for autonomous hormonal secretions by the adrenal tumors.
12000038|NCT00591643|Radiation|(NP-59)|One to 2 mCi of I 131 1,6-beta-iodomethyl-19-norcholesterol (NP-59) in 10% ethanol, 0.23% polysorbate 80 and 0.9% NaCl will be given intravenously slowly over 1-5 minutes.
12000039|NCT00591630|Drug|Zevalin|(111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
12000040|NCT00591630|Drug|Carmustine|300 mg/m^2 by vein.
12000041|NCT00591630|Drug|Etoposide|200 mg/m^2 by vein every 12 hours.
12000042|NCT00591630|Drug|Cytarabine|200 mg/m^2 by vein every 12 hours.
12000043|NCT00591630|Drug|Melphalan|140 mg/m^2 by vein.
12000044|NCT00591630|Drug|Rituximab|"Arm 1, Arm 2 = 250 mg/m^2 by vein;
~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;
~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy."
12000045|NCT00591630|Procedure|Stem Cell Transplant|Injection of stem cells (Autologous SCT)
12000046|NCT00591617|Other|Psychosocial treatment plus Suboxone pharmacotherapy|Participants randomly assigned to one of four psychosocial treatment conditions building on pharmacotherapy with Suboxone (buprenorphine + naloxone)
12000047|NCT00591604|Drug|Vitamin D|Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks
12000084|NCT00591266|Drug|Amlodipine|Azilsartan medoxomil placebo-matching tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
12000085|NCT00591253|Drug|Azilsartan medoxomil|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
12000048|NCT00591591|Device|OxiplexTS|OxiplexTS is a Frequency Domain Near-Infrared Tissue oximeter which provides absolute values of tissue oxygenation in real time. It also provides physiological quantities of oxy, deoxy and total hemoglobin concentration, which form the basis for the functional measurement of brain hemodynamics. Both the control and OSA groups will undergo standard overnight sleep study (PSG). In addition to the standard PSG, with or without Continuous Positive Airway Pressure (CPAP), we will add the OxiplexTS, allowing us to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to the OSA sufferers. Participants with OSA who undergo PSG/CPAP will be also tested with the OxiplexTS. Their PSGs and PSG/CPAP data will be compared.
12000049|NCT00591578|Drug|Azilsartan Medoxomil|Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
12000050|NCT00591578|Drug|Azilsartan Medoxomil|Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
12000051|NCT00591578|Drug|Valsartan|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
12000052|NCT00591565|Drug|Acamprosate|acamprosate 333mg tab, 3 by mouth 3 times a day
12000053|NCT00591552|Device|Harmonic ACE23P Scalpel|Lymph node dissection
12000054|NCT00591552|Device|Electrocautery|
12000055|NCT00591539|Procedure|Carotid Ultrasound|Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.
12000056|NCT00591526|Drug|Arac|Ommit ARAC in the chemotherapy
12000057|NCT00591500|Behavioral|Questionnaire|Exposures of interest will be measured by a self-administered personal residence, occupation and vacation calendar, a telephone interview, and by testing DNA from buccal cells and blood, when available. Standardization of diagnosis will be undertaken by review of tissue slides. Questionnaire data will be completed by interviewers. DNA will be obtained from each individual in the form of 4-6 buccal swabs
12000058|NCT00591500|Behavioral|Questionnaire|Exposures of interest will be measured by a self-administered personal residence, occupation and vacation calendar, a telephone interview, and by testing DNA from buccal cells and blood, when available. Standardization of diagnosis will be undertaken by review of tissue slides. Questionnaire data will be completed by interviewers. DNA will be obtained from each individual in the form of 4-6 buccal swabs.
12000059|NCT00591487|Drug|Lidocaine|Subcutaneous infiltration with Active/Placebo solutions with tumescent technique previous to suction assisted lipectomy. Patient abdomen and back will be divided in 4 zones anterior and posterior, one side (left or right) will be infiltrated with active solution and the other with placebo. The allocation of the side will be made with random numbers.
12000060|NCT00591474|Dietary Supplement|probiotics|100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks
12000061|NCT00591474|Dietary Supplement|yogurt|100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks
12000062|NCT00591448|Other|Virtual Reality (VR)|See above
12000063|NCT00591435|Other|Comparison of performance of consultants versus residents|Anesthesia as well as surgical workflow will be analysed. Performance of consultants will be compared to residents
12000064|NCT00591422|Drug|ZIO-101-C (Darinaparsin)|Capsule, Dose escalation study from 100 mg to 1000 mg (or Maximum Tolerated Dose). 3 times weekly (>36 hours between doses) for 3 weeks with 1 week rest.
12000065|NCT00591409|Drug|sugammadex|"After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered."
12000066|NCT00591409|Drug|Placebo|"After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of placebo IV was administered"
12000067|NCT00591396|Drug|ZIO-101 (Darinaparsin)|Dose Escalation of ZIO-101 (Darinaparsin) given daily for five consecutive days to be repeated every 28 days for up to six months
12000068|NCT00591383|Drug|indibulin|indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.
12000069|NCT00591383|Drug|erlotinib|erlotinib taken at 150 mg every morning with food.
12000070|NCT00591370|Drug|Temozolomide (TMZ)|One group treatment study
12000071|NCT00591357|Drug|loperamide|4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
12000072|NCT00591357|Drug|placebo|4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
12000073|NCT00591344|Behavioral|Progressive resistance training|Exercise twice a week for 2 years doing either progressive resistance training. The The PRE program consisted of 11 strengthening exercises: chest press, latissimus pull downs, reverse flys, double leg press, hip extension, shoulder press, biceps curl, rotary calf (ankle plantar flexion), triceps extension, seated quadriceps extension and back extension.
12000074|NCT00591344|Behavioral|Modified Fitness Counts|The modified Fitness Counts program was taken from Chapters 2 and 3 of the Parkinson's disease: Fitness Counts booklet and focused on non-progressive stretching, strengthening and balance exercises.
12000075|NCT00591331|Drug|Spinosad (the active ingredient in NatrOVA)|This is a patch test in which the test material is applied to the patch and the patch applied to the skin.
12000076|NCT00591331|Drug|placebo|
12000077|NCT00591318|Drug|ceftriaxone|2 grams of ceftriaxone given daily, Monday to Friday, excluding major holidays, for a total of 40 doses
12000078|NCT00591318|Drug|Normal Saline|50 cc of normal saline, daily, Monday through Friday, except for major holidays, for a total of 40 normal saline infusions.
12000079|NCT00591305|Dietary Supplement|diindolylmethane (DIM)|3-month DIM
12000080|NCT00591305|Device|585 nm pulsed dye laser|once-time PDL
12000081|NCT00591292|Drug|indibulin|Dose escalation of indibulin given twice daily for up to 6 months
12000082|NCT00591266|Drug|Azilsartan Medoxomil and amlodipine|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
12000083|NCT00591266|Drug|Azilsartan Medoxomil and amlodipine|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
12000086|NCT00591253|Drug|Azilsartan medoxomil|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
12000087|NCT00591253|Drug|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
12000088|NCT00591227|Drug|insulins aspart and detemir|insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
12000089|NCT00591214|Drug|MP-424 (Telaprevir)|Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)
12000090|NCT00591201|Drug|infliximab|Infliximab 5mg/kg diluted in 250 ml of isotonic solution of sodium chloride will be administered by the intravenous route on weeks 0, 2, 6, 12, 18, 24, 30, 36, 42, and 48.
12000091|NCT00591201|Drug|Placebo|Placebo -powder diluted in 250 ml of isotonic solution of sodium chloride- will be administered on weeks 0, 2 and 6.
12000092|NCT00591188|Drug|capecitabine, interferon-alpha|Patients who meet inclusion/exclusion criteria will receive combination of study drugs.
12000093|NCT00591175|Behavioral|Standard Care only|Dentist Provided Standard Care, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test
12000094|NCT00591175|Behavioral|Dental Hygienist provided counseling + Brief Questionnaire|Dental Hygienist provided + Brief Questionnaire, 3-month follow-up assessment,Clinic visit salivary cotinine test, 12-month follow-up, Clinic visit salivary cotinine test assessment
12000095|NCT00591175|Behavioral|Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire|Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test
12000096|NCT00591162|Drug|Tetracycline|Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.
12000097|NCT00591162|Radiation|Duel Energy X-Ray Absorptiometry (DEXA)|DEXA before discharge from acute admission and again one year post burn.
12000098|NCT00591162|Procedure|Bone Biopsy|Bone biopsy to be taken in the operation room at the last skin grafting operation at the site of the iliac crest. A second bone biopsy will be taken one year later post discharge from the acute admission.
12000099|NCT00591149|Drug|Oxaliplatin|130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
12000100|NCT00591149|Drug|Docetaxel|60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
12000101|NCT00591149|Drug|Cetuximab|400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
12000102|NCT00591136|Drug|indibulin|Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months
12000103|NCT00591123|Drug|FOLFOX and Erlotinib|Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
12000104|NCT00591110|Behavioral|Eye care education|Participants will receive an educational intervention communicating practical information about vision, eye conditions and eye care pertinent to the older African American population
12000105|NCT00591110|Behavioral|Social-contact control|Participants receive an engaging informational session on a non-health related topic
12000106|NCT00591084|Drug|ginsenoside-Rd 10 mg|infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
12000107|NCT00591084|Drug|placebo|infusion placebo (group B)once a day and continued for 14 days
12000108|NCT00591084|Drug|ginsenoside-Rd 20mg|infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days
12000109|NCT00591071|Other|Strict glycemic control|Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L
12000110|NCT00591071|Other|Conventional glycemic control|Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L
12000111|NCT00591058|Drug|TM-601|TM-601, administered intravenously (IV), once/week for 3 weeks
12000112|NCT00591045|Drug|mFOLFOX|oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ
12000113|NCT00591019|Drug|Modafinil|200 mg/day, morning dose
12000114|NCT00591019|Other|Placebo|Sugar pill once per day in the morning.
12000115|NCT00591006|Drug|Phenytoin (brand name Dilantin)|Three days prior to imaging, participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total).
12000116|NCT00591006|Drug|Hydrocortisone|Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The doses were selected to achieve a low therapeutic blood level of phenytoin and stress level of cortisol. Newcomer et al. (1999) used this dose of hydrocortisone in healthy controls. The imaging will be performed at approximately 1300 hours.
12000117|NCT00591006|Drug|Placebo|Participants take two capsules of placebo 100 mg at 0900 hours and 2100 hours for a total of 3 days with the last dose at 0900 hours on the day of imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating placebo), participants will being taking 4 tablets containing placebo (20 mg) also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total).
12000118|NCT00590993|Other|MRI and MRSI|Compare treatment impact when using MRI and MRSI
12000119|NCT00590967|Radiation|IMRT extended field external beam radiation therapy|
12000120|NCT00590967|Radiation|Brachytherapy|
12000121|NCT00590967|Drug|Cisplatin|
12000205|NCT00590187|Drug|sapacitabine|200 mg b.i.d. x 7 consecutive days every 4 weeks
12000206|NCT00590187|Drug|sapacitabine|300 mg q.d. x 7 consecutive days every 4 weeks
12000207|NCT00590187|Drug|sapacitabine|300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
12000208|NCT00590187|Drug|sapacitabine|200 mg b.i.d. x 7 consecutive days every 4 weeks
12000122|NCT00590954|Drug|Perifosine|"Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
12000123|NCT00590941|Procedure|Blood draw|Sample Collection for Genotyping prior to cycle 1 treatment of R-CHOP, if patient is enrolled after cycle 1, sample for genotyping should be collected prior to cycle 2.
12000124|NCT00590928|Drug|esomeprazole|40mg once daily
12000125|NCT00590928|Drug|ranitidine|50mg every h hours
12000126|NCT00590915|Drug|Erwinia L-asparaginase|"Substitute Erwinia L-asparaginase 25,000 international units per meters squared, IM every other day (including weekends and holidays) x 6 doses for each dose of PEG-asparaginase that is replaced.
~NOTE: Erwinia L-asparaginase dosing to replace native E.coli L-asparaginase varies; consult protocol for specifics."
12000127|NCT00590902|Drug|OSI-774: erlotinib, TarcevaTM|150 mg, 100 mg and 25 mg tablets
12000128|NCT00590889|Device|Artificial Mechanical Heart Valve|Both arms used market released mechanical heart valves in accordance with approved labeling
12000129|NCT00590863|Drug|SSRI + placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
12000130|NCT00590863|Drug|Escitalopram + Bupropion SR|Participant will take Burpopion SR (150 to 450 mg/day) + Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
12000131|NCT00590863|Drug|Venlafaxine XR + Mirtazapine|Participants will take Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
12000132|NCT00590850|Device|ORIF with Plate and Screws|ORIF with plate and screws
12000133|NCT00590850|Device|Pin Fixation|Clavicle fixation with clavicle pin
12000134|NCT00590837|Drug|Lomustine|"Induction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1.
~Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1.
~Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1."
12000135|NCT00590824|Drug|hu14.18-IL2|6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by surgery and up to 2 additional courses of hu14.18-IL2
12000136|NCT00590824|Drug|hu14.18-IL2|Surgery followed by 3 courses of 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course
12000137|NCT00590798|Behavioral|Walking|Patient will walk within 30 minutes of vascular closure system procedure
12000138|NCT00590785|Drug|Doxorubicin|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
12000139|NCT00590785|Drug|Cyclophosphamide|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
12000140|NCT00590785|Drug|G-CSF|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
12000141|NCT00590785|Drug|tamoxifen|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
12000142|NCT00590785|Drug|ciprofloxacin|High-dose sequential doxorubicin x 4 given with G-CSF on Days 3 - 12+ and followed by high-dose cyclophosphamide x 3 (A+C) given with G-CSF and ciprofloxacin on Days 3-12, followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamxifen 20 mg daily for 5 years.
12000143|NCT00590772|Drug|montelukast|10 mg po each day (compared to placebo for 2 weeks)
12000144|NCT00590772|Drug|placebo|placebo for 2 weeks
12000145|NCT00590759|Device|GORE TAG® Thoracic Endoprosthesis|implant
12000146|NCT00590720|Biological|MEDI528 50 mg|MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
12000147|NCT00590720|Other|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
12000148|NCT00590707|Device|Deeper sedation|The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
12000149|NCT00590707|Device|Moderate sedation|The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
12000150|NCT00590694|Drug|ranibizumab|0.5mg injection monthly according to protocol for one year
12000151|NCT00590681|Drug|Bevacizumab and Temozolomide|This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).
12000152|NCT00590668|Diagnostic Test|Transesophageal Echocardiography|Measurement of peak diastolic flow velocity
12000153|NCT00590655|Behavioral|weight loss programme with maintenance programme|After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.
12000154|NCT00590655|Behavioral|weight loss programme|
12000155|NCT00590629|Drug|Niaspan|1500 mg Niaspan for 16 weeks
12000156|NCT00590616|Procedure|transthoracic examination|observational transthoracic examination
12000209|NCT00590187|Drug|sapacitabine|300 mg q.d. x 7 consecutive days every 4 weeks
12000210|NCT00590187|Drug|sapacitabine|100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
12000211|NCT00590174|Drug|Aspirin|stopping clopidogrel at 1 year after DES implantation
12000157|NCT00590603|Drug|Arsenic Trioxide, Ascorbic Acid and Bortezomib|"Phase I/Cohort I
~Loading:
~Arsenic Trioxide (ATO): 0.25 mg/kg IV over 1-2 hr qd x 5 days (Monday-Friday)
~Ascorbic Acid: 1000 mg by IV infusion over 15 minutes after each infusion of arsenic trioxide qd x 5 days
~Maintenance cycles (21 days)
~ATO: 0.25 mg/kg IV over 1-2 hr once a week x 2 weeks every 3 weeks (one cycle) for a total of 6 cycles.
~Ascorbic Acid 1000mg IV will be given within 30 minutes of completion of ATO.
~Bortezomib 1 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 8 of a 21-day cycle. ATO is given at least one hour prior to Bortezomib. The first cycle will start on week 2, after loading dose week.
~Phase I/Cohort 1 is followed by Cohort 2. Phase II uses maximum tolerated dose from Phase I."
12000158|NCT00590590|Drug|Lidocaine/Diphenhydramine|semi solid, twice weekly, 4 months
12000159|NCT00590590|Drug|lidocaine|semi solid, twice weekly for 4 months
12000160|NCT00590590|Drug|placebo|semi solid, twice weekly for 4 months
12000161|NCT00590577|Drug|Paliperidone palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64
12000162|NCT00590577|Drug|Paliperidone palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64
12000163|NCT00590577|Drug|Placebo|Placebo i.m. Days 1, 8, 36, 64
12000164|NCT00590577|Drug|Paliperidone palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64
12000165|NCT00590564|Drug|Sho-saiko-to|All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks unless occurrence of unacceptable adverse events or patient withdrawal. Patients will be seen for clinical follow-up at three month intervals: at 3, 6, 9, and 12 months, and assessed for compliance and asked about side effects and pulmonary symptoms. At each clinic visit, a comprehensive metabolic profile will be performed. At the 6-month clinic visit, a CBC will be performed. At the 12-month clinic visit, quantitative HCV-RNA by PCR will be obtained (Viromed Labs, Inc., 6101 Blue Circle Drive, Minneapolis, MN 5534). Within 4 weeks after the 12-month clinic visit (after 52 weeks of SST therapy), the second liver biopsy will be scheduled and performed.
12000166|NCT00590551|Other|sling or no sling|Groups will be assigned as follows: 1-supine and with sling, 2-30o HOB elevation without leg elevation and with sling, 3-30o HOB elevation with 10o leg elevation and with sling, 4-supine and without sling, 5-30o HOB elevation without leg elevation and without sling, and 6-30o HOB elevation with 10o leg elevation and without sling
12000167|NCT00590538|Drug|Sodium 4-Phenylbutyrate|The standard oral adult dose is 20 g/day (tablets) for 4 days.
12000168|NCT00590538|Drug|Genistein (Unconjugated Isoflavones 100)|Every participant will be administered a perfusion of 50 MicroM of Genistein (Unconjugated Isoflavones 100) during the modified NPD procedure.
12000169|NCT00590538|Drug|Placebo|The placebo is given to match the active comparator for four days.
12000170|NCT00590525|Procedure|Cardioversion|Baseline hsCRP will be drawn the morning of, prior to, cardioversion. An EKG to document the patient's rhythm will be obtained at the one-month mark
12000171|NCT00590512|Dietary Supplement|High sodium|
12000172|NCT00590512|Dietary Supplement|Low sodium|
12000173|NCT00590473|Device|Interstim|Unilateral vs. Bilateral Placement of Interstim IPG
12000174|NCT00590460|Biological|CAMPATH-1H|Given intravenous on days -8, -7, and -6
12000175|NCT00590460|Biological|Anti-CD45|"Given intravenous on days -5, -4, -3 and -2
~dose is 400 micrograms/kg"
12000176|NCT00590460|Drug|Fludarabine|"Given intravenous on days -8, -7, -6, -5 and -4
~Dose is 30 mg/m2"
12000177|NCT00590460|Procedure|Stem cell infusion|Stem cells are infused on day 0
12000178|NCT00590447|Drug|rituximab monotherapy|375 mg/m2, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between course 4 and 5 the patients directly enter R-CHOP chemotherapy (Arm B).
12000179|NCT00590447|Drug|sequential R-CHOP|"375 mg/m2 rituximab, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. Cyclophosphamid 750 mg/m2, adriamycine 50 mg/m2 and vincristine 1.4mg/m2, IV and prednisone 50mg/m2, PO every 3 weeks at days 50, 72, 94 and 116.
~In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between antibody and R-CHOP administration the patients directly enter R-CHOP chemotherapy."
12000180|NCT00590408|Dietary Supplement|coenzyme Q10|60mg capsule twice daily for 12 weeks
12000181|NCT00590408|Dietary Supplement|matching placebo|matching placebo capsule twice daily for 12 weeks
12000182|NCT00590395|Drug|18FDG (an FDA-approved radiopharmaceutical)|Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
12000183|NCT00590382|Device|AMPLATZER Muscular VSD Occluder|AMPLATZER Muscular VSD Occluder
12000184|NCT00590369|Device|KCI -VAC|Negative pressure wound therapy device
12000185|NCT00590369|Device|Versatile One (EZCare)|Negative pressure wound therapy device
12000186|NCT00590356|Device|StarClose®|Closure device for femoral artery suture site occlusion
12000187|NCT00590356|Device|AngioSeal®|Closure device for femoral artery suture site occlusion
12000188|NCT00590343|Drug|vatalanib|Subjects who meet all inclusion and exclusion criteria will receive an initial dose of PTK787/ZK222584 1,250mg once daily, and subjects will remain on the scheduled doses of Sandostatin LAR 30mg every 4 weeks.
12000189|NCT00590317|Drug|Prochlorperazine|Patients receiving Prochlorperazine
12000190|NCT00590317|Drug|Ondansetron|Patients receiving Ondansetron
12000191|NCT00590278|Drug|Tomudex|
12000192|NCT00590278|Procedure|Radiotherapy|
12000193|NCT00590278|Procedure|Haematology|
12000194|NCT00590278|Procedure|Biochemistry|
12000195|NCT00590265|Device|Northern Light Technology (SADelite lamp) bright light-therapy|10 000 lux for 30 minutes
12000196|NCT00590265|Device|Northern Light Technology (SADelite lamp) Dim light-therapy|<100 lux for 30 minutes
12000197|NCT00590226|Drug|Detemir + aspart insulin before meals|Detemir insulin SQ once daily + aspart insulin SQ before meals
12000198|NCT00590226|Drug|NPH insulin + regular insulin|NPH insulin SQ + regular insulin SQ before breakfast and dinner
12000199|NCT00590213|Drug|Casodex 150mg|
12000200|NCT00590213|Procedure|Radiotherapy|
12000201|NCT00590213|Procedure|Haematology|
12000202|NCT00590187|Drug|sapacitabine|200 mg b.i.d. x 7 days every 3-4 weeks
12000203|NCT00590187|Drug|sapacitabine|300 mg b.i.d. x 7 days every 3 - 4 weeks
12000204|NCT00590187|Drug|sapacitabine|400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
12000214|NCT00590161|Drug|placebo|placebo tid
12000215|NCT00590135|Drug|atorvastatin (Lipitor)|atorvastatin 40 mg by mouth once daily
12000216|NCT00590122|Drug|Parcopa|at subjects current stable dose of comparator
12000217|NCT00590122|Drug|carbidopa-levodopa|at subjects current stable dose
12000218|NCT00590109|Other|Blood test|subjects will provide one 8ml blood sample drawn into one ACD tube and 16ml of blood drawn into two EDTA (purple top) tubes.
12000219|NCT00590109|Other|Questionnaire|A questionnaire encompassing medical, environmental exposure, and reproductive history.
12000220|NCT00590083|Biological|CTL administration|"Adenovirus specific T cells will be given by intravenous injection from day 30 post transplant.
~One infusion of Adenovirus-specific CTL given to patients at risk for Adenoviral disease after matched or mismatched unrelated or matched or mismatched related donor stem cell transplant. Four dose levels will be explored. The lowest level will be 1x dose of 5x10e6cells/m2 and the highest will be 1x dose of 1.35x10e8/m2."
12000221|NCT00590070|Drug|adenosine|Adenosine (80 mcg as fast bolus followed by 2 mg given in 33cc of saline in 2 minutes as slow bolus)
12000222|NCT00590070|Drug|nitroprusside|Nitroprusside (60 mcg as fast bolus followed by 100 mcg given in 33cc of 5% glucose in 2 minutes as slow bolus)
12000223|NCT00590070|Drug|placebo|33 cc of heparinized saline given in 2 minutes as slow bolus
12000224|NCT00590044|Drug|insulin glargine+ glulisine|Daily insulin glargine + glulisine before meals
12000225|NCT00590044|Drug|NPH + Regular insulin|Split-mixed NPH + Regular insulin twice daily
12000226|NCT00590031|Drug|Cisplatin|pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
12000227|NCT00590031|Drug|Irinotecan|Irinotecan will be given 65 mg/m2
12000228|NCT00590031|Radiation|External Beam Radiation Therapy|will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.
12000229|NCT00590018|Drug|Hydrocortisone|Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
12000230|NCT00590018|Drug|Placebo|Placebo for 5 days intravenously.
12000231|NCT00589992|Drug|Ibutilide fumarate|During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.
12000232|NCT00589979|Drug|Lidoderm (Lidocaine 5% Patch)|Topical Patch
12000233|NCT00589979|Drug|Placebo Patch|Topical Patch
12000234|NCT00589966|Behavioral|Coping Skills Training|Coping Skills Training teaches skills for managing physical, emotional, and social challenges of symptoms commonly experienced by men who have undergone treatment for early stage prostate cancer. Coping skills include activity pacing, managing negative mood, communication enhancement, and applied relaxation.
12000235|NCT00589966|Behavioral|Prostate Cancer Education|Prostate Cancer Education provides information on the following topics: common treatment side-effects, medical options for symptom management, nutrition to support recovery, and guidelines for communicating with your healthcare team.
12000236|NCT00589953|Drug|Erythropoietin|"5 of first 10 subjects (Group 1): 400 units/kg/dose once daily for 7 days 5 of next 10 subjects (Group 2): 800 units/kg/dose once daily for 7 days 20 of next 30 subjects (Group 3): 1000 units/kg/dose once daily for 7 days administered i.v. over 1 hour.
~The volume of the study drug will be 1 mL in a 1 mL Tuberculin syringe to be administered over 1 hour."
12000237|NCT00589953|Drug|Saline placebo|Saline vehicle at a volume of 1 mL given over 1 hour intravenously once a day for the first seven days of life.
12000238|NCT00589927|Drug|cilostazol|cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
12000239|NCT00589927|Drug|placebo|placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
12000240|NCT00589914|Drug|RISPERDAL CONSTA|RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.
12000241|NCT00589914|Drug|Paliperidone palmitate|PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.
12000242|NCT00589901|Drug|capecitabine and cyclophosphamide|"capecitabine 1000 mg/m2 oral Bid d1-14
~cyclophosphamide 65 mg/m2 oral Qd d1-14"
12000243|NCT00589888|Drug|Intralipid 20% @ 20cc/hour|In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting
12000244|NCT00589888|Drug|Intralipid 20%@ 40cc/hour|In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting.
12000245|NCT00589888|Drug|Normal Saline|In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours.
12000246|NCT00589888|Dietary Supplement|32-gram oral fat load|In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
12000247|NCT00589888|Dietary Supplement|64-gram oral fat load|In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
12000248|NCT00589875|Biological|AdV-tk|Single dose of 3x10e11 vector particles of AdV-tk delivered to the tumor bed after resection on day 0.
12000249|NCT00589875|Drug|Valacyclovir|Single course of valacyclovir at dose of 2 grams orally three times per day for 14 days starting on day 1-3
12000250|NCT00589862|Drug|Plavix (Clopidogrel)|150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified
12000251|NCT00589849|Procedure|T-wave Alternans|T-wave alternans is an electrocardiographic finding that is defined as the beat-to beat fluctuation in the amplitude or shape of T wave
12000252|NCT00589823|Drug|Fentanyl citrate|nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day
12000253|NCT00589823|Drug|Immediate release morphine sulphate|drug dose as required by patient taken to treat up to four epsiodes of BTCP per day
12000254|NCT00589797|Device|Activ-L Artificial Disc|Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
12000255|NCT00589797|Device|ProDisc-L Total Disc Replacement or Charité Artificial Disc|Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
12000256|NCT00589784|Drug|Sunitinib|The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days.
12000257|NCT00589771|Drug|Saccharomyces boulardii|"Saccharomyces boulardii one capsule 250mg TDS for 6 weeks
~Ispaghula husk 1 Tsf daily after dinner for six weeks"
12000258|NCT00589771|Drug|Placebo|"Cap Placebo TDS for six weeks
~Ispaghula husk 1 Tsf daily after dinner for six weeks"
12000259|NCT00589758|Diagnostic Test|Echocardiography|2D and 3D echocardiography
12000260|NCT00589758|Other|Biomarker evaluation|Blood and urine collected
12000261|NCT00589745|Other|Nasal potential difference measurement|Nasal potential difference measurement involves dripping small amounts of 5 test solutions into the anterior nostril. This is designed to test the ability of the cells to regulate the movement of salt and water in people with features of CF in whom the diagnosis is not entirely clear.
12000262|NCT00589732|Drug|Valsartan|Valsartan 160mg per day
12000263|NCT00589706|Drug|MAb-425|MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.
12000264|NCT00589693|Drug|Doripenem|Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 4-hour infusion of doripenem will be administered every 8 hours for 7 days.
12000265|NCT00589693|Drug|Imipenem-Cilastatin|Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 1-hour infusion of imipenem-cilastatin will be administered every 8 hours for 10 days.
12000266|NCT00589693|Drug|Placebo|Form=solution, route=intravenous. Doripenem pacebo will be administered from Days 1 to 7 in imipenem-cilastatin arm and imipenem-cilastatin placebo will be administered in doripenem arm.
12000267|NCT00589667|Drug|Pemetrexed plus Gemcitabine|"Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
~Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed.
~For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist."
12000268|NCT00589654|Other|Questionnaire|Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.
12000269|NCT00589641|Behavioral|CBT-RP (relapse prevention) + Enhanced TAU|CBT-RP is an 20-week augmenting intervention. CBT-RP is based primarily on Alan Marlatt's cognitive behavioral relapse prevention model for substance abuse, but also includes motivational interviewing and mindfulness meditation approaches. Sessions are twice a week in first week, then weekly thereafter, with tapering to biweekly in the last 8 weeks depending on improvement. Participants also receive treatment as usual, and monthly check-ins regarding treatment use.
12000270|NCT00589641|Behavioral|Enhanced TAU Alone|Treatment as usual in the community, monthly check-ins regarding treatment use or needs, and monitoring
12000271|NCT00589628|Drug|infliximab|5mg/kg/dose IV at 4 week intervals
12000272|NCT00589628|Drug|infliximab|10mg/kg/dose IV at 4 week intervals
12000273|NCT00589615|Behavioral|multidisciplinary osteoporosis prevention educational program|The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.
12000274|NCT00589602|Procedure|peripheral blood lymphocyte therapy|T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.
12000275|NCT00589602|Procedure|allogeneic hematopoietic stem cell transplantation|Allogeneic Hematopoietic Stem Cell Transplantation
12000276|NCT00589602|Procedure|peripheral blood stem cell transplantation|Peripheral blood stem cell transplantation
12000277|NCT00589602|Radiation|total-body irradiation (TBI)|Treatment will be delivered using 6MV photons twice daily for 3 days
12000278|NCT00589589|Device|Endo Tool|Computer tool to help achieve glucose control
12000279|NCT00589563|Biological|anti-thymocyte globulin|0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.5 mg/kg on day -1 or day 0 from stem cell transplant
12000280|NCT00589563|Drug|cyclophosphamide|60mg/kg on days -5 and -4 from stem cell transplant
12000281|NCT00589563|Drug|etoposide|60mg/kg on day -4 from stem cell transplant
12000282|NCT00589563|Drug|fludarabine phosphate|Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant
12000283|NCT00589563|Drug|melphalan|Melphalan 140 mg/m2 on day -4 from stem cell transplant
12000284|NCT00589563|Drug|methotrexate|For high risk HLA-mismatch transplant only: 5 mg/m2 on days +1, +3 and +6 from stem cell transplant
12000285|NCT00589563|Drug|sirolimus|"Adults: 12 mg loading dose on day -3 from stem cell transplant followed by 4 mg orally single morning daily dose.
~Pediatric Patients <40kg: 3 mg/m2 orally on day -3 from stem cell transplant followed by 1 mg/m2 orally single morning daily dose"
12000286|NCT00589563|Drug|tacrolimus|0.02 mg/kd/d CIV beginning on day -3 from stem cell transplant
12000287|NCT00589563|Procedure|allogeneic hematopoietic stem cell transplantation|The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
12000288|NCT00589563|Procedure|hematopoietic stem cell transplantation|The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
12000289|NCT00589563|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant, Melphalan 140 mg/m2 on day -4 from stem cell transplant
12000290|NCT00589563|Procedure|peripheral blood stem cell transplantation|The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
12000291|NCT00589563|Radiation|total-body irradiation|1320 cGy in 11 fractions from day -8 to day -5 or day -9 to day -6 prior to stem cell transplant
12000292|NCT00589550|Biological|PEG-interferon alfa-2b|administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
12000293|NCT00589550|Drug|Sorafenib|
12000294|NCT00589550|Genetic|gene expression analysis|
12000295|NCT00589550|Genetic|polymerase chain reaction|
12000296|NCT00589550|Genetic|reverse transcriptase-polymerase chain reaction|
12000297|NCT00589550|Other|flow cytometry|
12000298|NCT00589550|Other|immunoenzyme technique|
12000299|NCT00589550|Other|laboratory biomarker analysis|
12000300|NCT00589537|Other|questionnaire administration|
12000301|NCT00589537|Procedure|computed tomography|
12000302|NCT00589537|Procedure|magnetic resonance imaging|
12000303|NCT00589537|Procedure|quality-of-life assessment|
12000304|NCT00589524|Device|Computed tomography (CT)|Computed tomography (CT), as performed by Dual Source Computed Tomography (DSCT)(Siemens Medical Solutions Germany) to be conducted no sooner than 3 days before or after cardiac catheterization, but with 3 months of the cardiac cath.
12000305|NCT00589498|Dietary Supplement|1000 extra calories|Each subject received 1000 kcal/d in addition to weight maintenance requirements. The diet composition throughout the study was 40% carbohydrate, 40% fat, and 20% protein.
12000306|NCT00589485|Device|Simplex® Bone Cement|This arm will utilize Simplex® Bone Cement in total knee replacement.
12000307|NCT00589485|Device|Cobalt™ Bone Cement|This arm utilizes Cobalt™ Bone Cement in total knee replacement.
12000308|NCT00589472|Drug|Bicalutamide|Given PO
12000309|NCT00589472|Drug|Goserelin Acetate|Given SC
12000310|NCT00589472|Other|Laboratory Biomarker Analysis|Correlative studies
12000311|NCT00589472|Drug|Leuprolide Acetate|Given IM
12000312|NCT00589472|Procedure|Therapeutic Conventional Surgery|Undergo radical prostatectomy
12000313|NCT00589472|Drug|Vorinostat|Given PO
12000314|NCT00589446|Device|Hysteroscope|An 8mm hysteroscope with irrigation channel and 30 degree view will be inserted into the uterus prior to curettage in cases of recurrent missed abortion
12000315|NCT00589420|Drug|docetaxel|
12000316|NCT00589420|Drug|sorafenib tosylate|
12000317|NCT00589394|Biological|pneumococcal vaccination (Pneumovax)|pneumovax was given
12000318|NCT00589381|Drug|fenretinide lipid matrix|
12000319|NCT00589368|Behavioral|Transfer of grasp control across hands|transfer of planning and execution of grasp across hands in terms of its effect on fingertip forces, and the timing and magnitude of muscle contraction in patients with hemiparesis and healthy controls
12000320|NCT00589329|Drug|erythromycin and metronidazole (antibiotics)|"Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.
~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days"
12000321|NCT00589329|Drug|placebo|IV and pill placebo
12000322|NCT00589316|Procedure|Allogeneic Bone Marrow Transplantation|Given via central line
12000323|NCT00589316|Drug|Cyclophosphamide|Given IV
12000324|NCT00589316|Drug|Fludarabine Phosphate|Given IV
12000325|NCT00589316|Radiation|Iodine I 131 Monoclonal Antibody BC8|Given IV (dosimetry dose) or via central line (therapeutic dose)
12000326|NCT00589316|Other|Laboratory Biomarker Analysis|Correlative studies
12000327|NCT00589316|Drug|Mycophenolate Mofetil|Given IV or PO
12000328|NCT00589316|Drug|Tacrolimus|Given IV or PO
12000329|NCT00589316|Radiation|Total-Body Irradiation|Undergo TBI
12000330|NCT00589303|Drug|FDA approved rate and rhythm control drugs|"Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.
~Rate Control:
~Beta-Blocker:
~metoprolol
~atenolol
~carvedilol
~Calcium Channel Blocker:
~verapamil
~diltiazem
~Rhythm Control:
~procainamide
~quinidine
~disopyramide
~propafenone
~flecainide
~sotalol
~dofetilide
~amiodarone"
12000331|NCT00589303|Device|AV Node ablation and device implant|"Pacing Systems:
~Enpusle Premarket Approval Number (PMA#) P980035
~EnRhythm PMA# P980035
~Adapta PMA# P980035
~Cardiac Resynchronization Therapy (CRT) Pacing Systems:
~- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031
~Implantable Cardioverter-Defibrillator (ICD) Pacing Systems:
~EnTrust PMA# P980016
~Virtuoso PMA# P980016
~ICD CRT Pacing Systems:
~InSync Maximo PMA# P980016
~InSync Sentry PMA# P890003
~Concerto PMA# P980016"
12000332|NCT00589290|Drug|Belinostat (PDX101)|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
12000333|NCT00589277|Behavioral|"Yale coaching"|Novel messages for quitting smoking
12000334|NCT00589277|Behavioral|Standard care|Standard messages for quitting smoking
12000335|NCT00589264|Dietary Supplement|zinc|10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age
12000336|NCT00589264|Dietary Supplement|iron + copper|10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age
12000383|NCT00588952|Drug|Ketamine and Placebo|Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes
12000384|NCT00588939|Device|Cell~vizio (Laser connfocal microscopy)|completed during endoscopy
12000696|NCT00586118|Drug|Propofol|Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours
12000337|NCT00589251|Other|penicillin skin test|"Prick skin tests will be performed on the volar surface of the forearm with each penicilloate and control reagents. The skin test sites will be examined at 15 minutes. A positive test result is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. Patients with negative prick test results to penicillin will undergo intradermal testing.
~Intradermal skin tests will be performed on the volar surface of the forearm. The test reagents will be injected intradermally to produce an initial wheal of 2x2 mm. The skin test sites will be examined at 15 minutes. A positive intradermal test is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. In order to ensure patient safety, we will consider using an end point titration technique."
12000338|NCT00589238|Drug|carboplatin|
12000339|NCT00589238|Drug|cyclophosphamide|
12000340|NCT00589238|Drug|doxorubicin hydrochloride|
12000341|NCT00589238|Drug|paclitaxel|
12000342|NCT00589225|Genetic|Genetic Analysis|We will draw one tube of blood from your arm to obtain white blood cells. These white blood cells will be used as a source of DNA for genetic testing.
12000343|NCT00589212|Device|GliaSite Radiation Therapy System|GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity.
12000344|NCT00589199|Procedure|Placement and use of the device|Surface electrodes currently used for peripheral muscle stimulation by other groups will be applied to the abdominal wall and over the posterior lower thoracic rib cage. Between two and three pairs (anodic and cathodic) of electrodes will be used in combination to activate the expiratory muscles. Electrodes will be positioned at various points over the abdominal wall and the posterior thoracic rib cage to ascertain optimal placement for airway pressure and expiratory airflow generation. The electrical stimulators to be used (EMPI and NeuroMedic) are powered by 9-volt batteries. These stimulators are currently in clinical use to stimulate other skeletal muscles and are known to be quite safe.
12000345|NCT00589186|Biological|Ad5F35-LMP1/LMP2-transduced autologous dendritic cells|
12000346|NCT00589186|Drug|celecoxib|
12000347|NCT00589186|Other|flow cytometry|
12000348|NCT00589186|Other|immunoenzyme technique|
12000349|NCT00589186|Other|laboratory biomarker analysis|
12000350|NCT00589173|Behavioral|Interactive Preventive Health Record (IPHR)|Preventive health record designed to a) show patients the status of their preventive care recorded in their electronic record and b) make recommendations on what USPSTF endorsed preventive services that the user needs to receive.
12000351|NCT00589173|Behavioral|"Standard preventive care"|Existing mechanisim for receiving preventive care in primary care (i.e. patients not referred to the IPHR).
12000352|NCT00589147|Device|The Zimmer NexGen Legacy Knee System, modular cemented tibia|modular cemented tibia
12000353|NCT00589147|Device|The Zimmer NexGen Legacy Knee System, non-modular cemented tibia.|non-modular cemented tibia.
12000354|NCT00589147|Device|The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia|non-modular uncemented tibia
12000355|NCT00589134|Dietary Supplement|Gatorade Endurance Formula|carbohydrate electrolyte beverage
12000356|NCT00589134|Other|ganirelix acetate|GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days.
12000357|NCT00589121|Drug|Chemotherapy|Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
12000358|NCT00589121|Radiation|Radiation therapy|Preoperative IGRT (3D-CRT or IMRT): If receiving neoadjuvant or adjuvant chemotherapy or no chemotherapy: 50 Gy (2 Gy once a day, 5 times a week). If receiving concurrent or interdigitated chemotherapy: 44 Gy (2 Gy once a day, 5 times a week). Postoperative radiotherapy boost for patients with positive margins following surgery: 16 Gy (2 Gy once a day, 5 times a week) external beam radiation therapy or 16 Gy at ≤ 80 cGy per hour brachytherapy or 3.4 Gy/fraction in 4 fractions brachytherapy or 10-12.5 Gy in a single fraction intraoperative radiation therapy boost.
12000359|NCT00589121|Procedure|Surgery|Resection of the sarcoma with the goal of having negative pathologic margins. Every effort should be made to have limb preservation surgery unless there is documented evidence of tumor progression that would require amputation for an appropriate negative margin resection. All lesions of the extremities should be treated with wide excision.
12000360|NCT00589108|Device|Sigma Knee System|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
12000361|NCT00589108|Device|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
12000362|NCT00589108|Device|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray|Sigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an all polyethylene tray)
12000363|NCT00589095|Other|dynamic contrast enhanced magnetic resonance imaging|dynamic contrast enhanced MRI using contrast agent gadodiamide
12000364|NCT00589082|Drug|DaunoXome|
12000365|NCT00589082|Drug|Daunorubicine|
12000366|NCT00589056|Drug|cisplatin|
12000367|NCT00589056|Drug|etoposide|
12000368|NCT00589056|Drug|nelfinavir mesylate|
12000369|NCT00589056|Genetic|protein expression analysis|
12000370|NCT00589056|Other|immunohistochemistry staining method|
12000371|NCT00589056|Other|laboratory biomarker analysis|
12000372|NCT00589056|Procedure|biopsy|
12000373|NCT00589056|Radiation|radiation therapy|
12000374|NCT00589030|Radiation|brachytherapy|The target dose of TheraSphere® is 80-150Gy
12000375|NCT00589030|Radiation|yttrium Y 90 glass microspheres|The target dose of TheraSphere® is 80-150Gy
12000376|NCT00588991|Drug|Carboplatin|Given IV
12000377|NCT00588991|Other|Laboratory Biomarker Analysis|Correlative study
12000378|NCT00588991|Drug|Topotecan Hydrochloride|Given IV
12000379|NCT00588991|Drug|Veliparib|Given orally
12000380|NCT00588978|Behavioral|diet and/or exercise|Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
12000381|NCT00588965|Drug|Placebo|Placebo will be given 1 pill daily for a week, then 2 pills daily, followed by the exercise test.
12000382|NCT00588965|Drug|Propranolol LA|Subjects will receive propranolol LA 80 mg one pill daily for 1 week then 2 pills daily for 1 week followed by exercise test.
12000385|NCT00588926|Drug|Remifentanil|After the mapping electrode is in situ, recording of baseline electrical activity is done for two-three minutes and an infusion of Remifentanil, 0.1 microgram per kilogram per minute is started. This procedure continues for a few minutes until the patient is sedated and then the infusion is stopped and the patient allowed to recover. The recordings continue during the whole procedure.
12000386|NCT00588913|Biological|aldesleukin|
12000387|NCT00588913|Biological|therapeutic autologous lymphocytes|
12000388|NCT00588913|Drug|zoledronic acid|
12000389|NCT00588900|Drug|cediranib maleate|
12000390|NCT00588900|Drug|irinotecan hydrochloride|
12000391|NCT00588887|Device|Duracon®|This group utilizes the Duracon® prostheses for total knee replacement.
12000392|NCT00588887|Device|Vanguard™|This group will utilize the Vanguard™ prostheses for total knee replacement.
12000393|NCT00588861|Device|Answer® hip stem|Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
12000394|NCT00588861|Device|Answer® hip stem|Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
12000395|NCT00588848|Device|Autoadjusting CPAP (VPAP Auto)|An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery).
12000396|NCT00588848|Device|CPAP|Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)
12000397|NCT00588835|Drug|aprepitant|125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
12000398|NCT00588835|Drug|Dexamethasone and Ondansetron during CE-treatment|Standard anti-emetic regimen during CE treatment
12000399|NCT00588822|Biological|Rituximab|Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22).
12000400|NCT00588809|Drug|selumetinib|Given PO
12000401|NCT00588783|Device|I-beam design|This group will utilize tibial components with an I-beam design for total knee replacement.
12000402|NCT00588783|Device|Cruciate design|This group will utilize tibial components with cruciate designs for total knee replacement.
12000403|NCT00588770|Biological|Bevacizumab|Given IV
12000404|NCT00588770|Drug|Carboplatin|Given IV
12000405|NCT00588770|Drug|Cisplatin|Given IV
12000406|NCT00588770|Drug|Docetaxel|Given IV
12000407|NCT00588770|Drug|Fluorouracil|Given IV
12000408|NCT00588770|Other|Laboratory Biomarker Analysis|Correlative studies
12000409|NCT00588757|Device|Optease IVC filters|IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
12000410|NCT00588757|Device|Gunter-Tulip IVC filters|IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
12000411|NCT00588731|Drug|Cannabidiol|Active Cannabidiol daily over 6 weeks
12000412|NCT00588731|Drug|Placebo|Placebo
12000413|NCT00588705|Behavioral|focus group & questionaire|The focus group will last about 90 minutes. However, your involvement in this study will last from the time you join until you read over the summary of what happened during the focus group and return your comments. This should be approximately 2 months. Patient will complete a questionnaire and we estimate total time for completion to be approximately 7 minutes.
12000414|NCT00588692|Device|SphygmoCor|The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure.
12000415|NCT00588679|Other|Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging|All MR examinations will be performed on a 3.0 Tesla whole body GE MR scanner located at the main campus (1275 York Avenue) or the Breast and Imaging Center (BAIC)(located on Second Ave. between 65th and 66th Streets). The MR examination will include MR imaging and spectroscopic imaging employing a combined torso phased array and endorectal coil receiver. The examination will require one hour to one hour and ten minutes.
12000416|NCT00588666|Drug|Bevacizumab|
12000417|NCT00588666|Drug|Carboplatin|
12000418|NCT00588666|Drug|Gemcitabine|
12000419|NCT00588653|Device|Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through|Each patient undergoes each of the 4 diagnostic modalities, but the readers are blinded to results of the other 3.
12000420|NCT00588640|Drug|d-Methadone|8 subjects to receive 40 mg d-Methadone twice a day
12000421|NCT00588640|Drug|D-methadone|After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
12000422|NCT00588640|Drug|placebo|After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
12000423|NCT00588588|Procedure|Bronchoscopy|Bronchoscopy procedure
12000424|NCT00588588|Procedure|Clinical pulmonary infection score (CPIS)|Calculate CPIS
12000425|NCT00588536|Drug|Methotrexate|MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
12000426|NCT00588536|Drug|6-Thioguanine|6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
12000427|NCT00588536|Drug|Leucovorin Calcium|5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)
12000428|NCT00588523|Drug|temozolomide followed by high dose busulfan and thiotepa|Temozolomide 200mg/m2 PO Days 1-5 recycled every 28 days Day minus -8 thiotepa 250 mg/m2 intravenously Day minus -7 thiotepa 250 mg/m2 intravenously Day minus -6 thiotepa 250 mg/m2 intravenously Day minus -5 busulfan 3.2 mg/kg intravenously over two hours Day minus -4 busulfan 3.2 mg/kg intravenously over two hours Day minus -3 busulfan 3.2 mg/kg intravenously over two hours Day minus -2 rest Day minus -1 rest Day 0 peripheral blood stem cell or bone marrow reinfusion
12000429|NCT00588510|Other|Blood draw|Peripheral blood samples (6-9 ml) will be collected in purple top tubes, when routine laboratory tests are being drawn. The blood will be drawn through central venous catheters, whenever possible. Blood will be drawn once from patients with malignant diagnoses other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma. In patients with osteosarcoma we will obtain blood when baseline laboratory tests are obtained, after every two cycles of treatment (approximately every six weeks), at the end of planned surgery and chemotherapy, every three months for the first year off therapy and yearly thereafter. We will also obtain blood if the patient relapses.
12000430|NCT00588497|Procedure|Micro-insert hysteroscopic sterilization|Placement of micro-inserts transcervically with the aid of a hysteroscope
12000431|NCT00588497|Radiation|Plain abdominal Xray|Performed immediately after micro-inserts placement and at 3 months
12000432|NCT00588497|Procedure|Pelvic Ultrasound|Performed immediately after micro-inserts placement and at 3 months.
12000433|NCT00588497|Radiation|Hysterosalpingogram|Performed 3 months after micro-inserts placement
12000434|NCT00588471|Drug|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
12000435|NCT00588471|Drug|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
12000436|NCT00588458|Procedure|CT cholangiography|Cholografin 20ml will be diluted in 100 ml of normal saline and infused over 30 minute time interval. Following the infusion of the cholografin, morphine (0.04 mg/kg) will be administered to contract the sphincter of Oddi and improve bile duct distension and visualization. Thirty minutes following the administration of morphine a test scan (CT cholangiography) will be performed through the liver to determine if there is adequate biliary excretion. The test scan will consist of 10 mm thick image obtained through the mid liver. If there is evidence of biliary excretion, high-resolution images will be performed through the liver and bile ducts. The axial images will be reconstructed into maximum intensity projection models and volume rendered models that can be viewed in 3-dimension.
12000437|NCT00588445|Drug|Gefitinib|"Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.
~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
12000438|NCT00588419|Behavioral|breast exam and questionaire|A physical examination of your breast(s), we will ask you to complete a short questionnaire that asks questions regarding sensations in your reconstructed breast(s) and another short questionnaire that asks questions regarding your medical and surgical history. The physical examination and the questionnaires will be completed in the outpatient clinic. This should take about 30 minutes to complete.
12000439|NCT00588406|Drug|Budesonide|2mg/dose by nebulizer, four doses over 3 hours
12000440|NCT00588406|Drug|albuterol|2.5mg/dose by nebulizer, 7 doses over 6 hours
12000441|NCT00588406|Drug|Ipratropium bromide|2.5 mg, one dose
12000442|NCT00588406|Drug|Prednisone|60mg PO
12000443|NCT00588393|Drug|FolateScan (Technetium Tc 99mEC20)|0.1 mg. of EC20 labeled with 20-25 mCi of technetium-99m followed by FolateScan
12000444|NCT00588380|Drug|GLP-1|GLP-1 infused at 0.75 pmol/kg/min from 121-180 minutes, GLP-1 infused at 1.55 pmol/kg/min from 181-240 minutes,
12000445|NCT00588367|Device|Mayo Interactive Breath Hold Monitor|Biofeedback device
12000446|NCT00588354|Drug|Clonidine|200 or 400 micrograms clonidine
12000447|NCT00588354|Drug|Triamcinolone hexacetonide|40 or 80 milligrams triamcinolone
12000448|NCT00588354|Drug|Lidocaine HCl|1 ml 2% lidocaine (20 mg/mL)
12000449|NCT00588341|Drug|Temozolomide|"At the start of the trial a core needle biopsy of a palpable tumor will be obtained percutaneously in the office after administration of local anesthesia. Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks. After each cycle, patients will be re-evaluated for response.
~Responding patients will be offered another cycle of treatment. Patients will be treated until best response, progression of disease, or 6 cycles, whichever comes first.
~After completing temozolomide treatment, patients will be evaluated for surgical resection. It is expected that, unless there is progression of disease, patients will undergo resection (i.e. therapeutic lymph node dissection). In patients who have a complete clinical response to temozolomide, whether or not to do a subsequent lymph node dissection will be left up to the discretion of the surgeon and the patient."
12000450|NCT00588328|Device|PET/CT scan|PET/CT scans
12000451|NCT00588302|Drug|Moexipril|Moexipril was given at a starting dose of 7.5 mg daily for 1 week to all enrolled patients. If tolerated (no clinically significant hypotension or medication associated adverse event), the daily dosage was increased to 15 mg daily at the beginning of the 2nd treatment week. Patients took moexipril orally in the morning and 1 hour prior to food intake. The target dose was maintained for the 1-year period of the study unless the development of toxicities warranted dose reduction or discontinuation.
12000452|NCT00588276|Radiation|124I-Iodo-Azomycin Galacto-Pyranoside|You will receive the radioactive tracer through an injection in your vein. Blood (about 5 tablespoons in all) will be taken after the radioactive tracer has been given. Over the course of study day 1, bloods will be drawn 8 times and then 4 more times on study day 2. You will undergo three *IAZGP PET scans, one shortly after you receive the injection, one later the same day and one the following day. Each scan will take about an hour. This means you would be asked to come back 2 days in a row.
12000453|NCT00588250|Other|EmbryoGlue|G2 culture media from Vitrolife which contains hyaluronic acid
12000454|NCT00588237|Drug|Paclitaxel,Cisplatin, Bevacizumab|IV paclitaxel, followed by IV Bevacizumab on Day 1. Bevacizumab treatment will begin cycle 2, day 1. IP cisplatin will be given on Day 2, and IP Paclitaxel on Day 8. Subjects will receive up to six cycles of therapy, or until disease progression or unacceptable toxicity.
12000455|NCT00588224|Other|3D ultrasound|measurement of stomach volume by 3D ultrasound
12000456|NCT00588211|Behavioral|Interviews|45-minute individual interviews after the conclusion of their dental appointment
12000457|NCT00588211|Behavioral|focus group|A focus group of the preliminary cancer-related risk perception item pool.
12000458|NCT00588211|Behavioral|Survey|Quantitative item analysis of the final item pool.
12000459|NCT00588211|Behavioral|Survey|A second confirmatory factor analysis.
12000519|NCT00587561|Behavioral|Social Cognition Interaction Training|manualized group therapy
12000520|NCT00587561|Behavioral|WLC|wait-list control for 6 months, followed by the experimental group therapy
12000460|NCT00588185|Drug|[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone|Registered patients will undergo PET scanning using either FDHT alone or FDG and FDHT depending on the clinical question being asked. Scans will be performed serially at baseline, week 4, week 12, and every 12 weeks of treatment up to a maximum of 8 FDHT/FDG scan set in a 12 month period (maximum 40 scan sets per lifetime) unless the therapeutic protocol or scientific rationale of the therapeutic drug being applied specifically dictates an alternative schedule. Patients may have blood drawn for the purposes of establishing the pharmacokinetics of FDHT and may also undergo an initial dynamic scan if further pharmacokinetic information is warranted, followed by a standard whole body image. If no further pharmacokinetic information is warranted, then patients will only undergo a standard whole body image.
12000461|NCT00588172|Drug|Metformin|1000mg bid for 1 week
12000462|NCT00588159|Drug|Gabapentin|gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
12000463|NCT00588159|Drug|Diphenhydramine|Diphenhydramine 12.5 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
12000464|NCT00588146|Drug|Pegylated Interferon Alpha2b|Weekly subcutaneous injection of 1 microgram/kg/week
12000465|NCT00588146|Other|Standard care|Standard care
12000466|NCT00588133|Drug|tranexamic acid|"Loading dose: 6.6 mg/kg Prime dose: 50 mg for 2.5 Liter circuit (assuming 1 L/kg Vd in prime fluids), 40 mg for 2 Liter circuit Rate of infusion: 6 mg/kg/hr
~Renal Insufficiency (normal loading dose and prime dose):
~Serum Creatinine = 1.6-3.3: reduce infusion to 4.5 mg/kg/hr Serum Creatinine = 3.3-6.6: reduce infusion to 3.0 mg/kg/hr Serum Creatinine = >6.6: reduce infusion to 1.5 mg/kg/hr"
12000467|NCT00588133|Drug|tranexamic acid|10 mg/kg tranexamic acid given over 20 minutes followed by an infusion of 1 mg/kg/hr
12000468|NCT00588120|Drug|C-13 labeled oxalate|"A single prescribed dose of C-13 labeled oxalate will be given orally in capsule form or in jello. Urine will be collected for 24 hours after the dose.
~Take one capsule by mouth for one day."
12000469|NCT00588107|Other|Web Intervention|Receives pharmacotherapy and access to an interactive Web site (Web condition). The Web site will offer tailored intervention messages and strategies in an interactive format that is much less labor-intensive and costly than the prior PFH peer telephone counseling intervention.
12000470|NCT00588107|Behavioral|print materials|tailored print materials designed to aid in smoking reduction and cessation
12000471|NCT00588094|Drug|Rituximab, Ifosfamide, Carboplatin, VP-16, Mesna, G-CSF, Stem Cell Transplant|"ANC must be ≥1000/µl and platelet count must be ≥50,000/µl. Rituximab will be administered at a dose of 375 mg/m2 IV on days 1 and 3 of the each cycle. Premedication will be given.ICE will be administered as follows: Day 3: Etoposide 200 mg/m2 IV q12 hrs x 3. Day 4: Ifosfamide 10 g/m2 and MESNA 10 g/m2 mixed and infused together as a continuous infusion over 48 hours. Day 5: Carboplatin IV dosed by the Calvert formula using an AUC of 5.
~Carboplatin dose (mg) = 5 x (Clcr + 25) For the first ten patients enrolled, G CSF will be administered beginning on day seven of each cycle and G CSF will continue until stem cell collection is completed. The dose will be 960 ug or 10 ug/kg if weight is greater than 100 kg.
~For the remaining patients, G-CSF will be administered for 10 days beginning on day 7 for cycle 1. The dose will be 300-480 ug/d. For cycle 2 the dose will be 960 ug or 10ug/kg if weight is > 100kg. Leukapheresis will continue."
12000472|NCT00588081|Behavioral|QOL|Those women who chose to have an interview will be scheduled for a 45 to 60 minute open-ended interview with a trained research assistant and sign consent at the time of the interview.
12000473|NCT00588068|Other|Tumor and Marrow Markers|Tumor and Marrow Markers
12000474|NCT00588042|Device|Blood pressure cuff|Arm ischemia will be induced using a blood pressure cuff that will be placed around the upper part of the arm, and inflated to 200 mm Hg for 3-minutes and then deflated for 3-minutes
12000475|NCT00588042|Device|blood pressure cuff|3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia
12000476|NCT00588016|Drug|Itraconazole|Topical application of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily for 7 days.
12000477|NCT00588003|Drug|anastrozole|anastrozole 1mg/day 11 days before their surgery and to take the last dose of the oral endocrine agent (anastrozole) on the day before their surgery.
12000478|NCT00588003|Other|Placebo|No medication before surgery
12000479|NCT00587990|Biological|Lower dose mesenchymal stem cell (MSC) injection|Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 10^7 cells. The injections will be administered following completion of CABG surgery.
12000480|NCT00587990|Genetic|Placebo|Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).
12000481|NCT00587990|Biological|Higher dose MSC injection|Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 10^8 cells. The injections will be administered following completion of CABG surgery.
12000482|NCT00587964|Radiation|Stereotactic Radiosurgery|"All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases. The patient will initially receive premedication with 0.5- 1mg of Ativan orally prior to SRS procedure. Subsequently, the patient will have the stereotactic head ring placement under local anesthesia. A peripheral IV will be placed for administration of the intravenous contrast. Thin-section CT images will be obtained with intravenous contrast with head ring in place for the purpose of treatment planning.
~A fusion program will be used to combine the recently obtained MRI images along with the CT scans. The target volume as well as the critical structures will be contoured. SRS would be delivered using either the Brain Lab or Radionics Radiosurgery planning and delivery system. Patients would receive a single treatment ranging from 15-22 GY."
12000521|NCT00587548|Other|Localizing the ureters during surgery|One-time injection 4.5mCi of 99mTechnetium labeled diethylene-triamine-penta acetate (DTPA) prior to the time of ureteral localization. The Neoprobe 2000 gamma probe will be utilized for ureter location.
12000483|NCT00587925|Other|Bone Mineral Density|Clinic visits twice during the first 2 years of the study with medical care directed by your treating doctor.BMD is measured by an X-ray test. The most common type of BMD testing is by energy x-ray absorptiometry (DEXA). Usually BMD is measured every other year, but to closely monitor women on this study, the BMD will be evaluated more often. The BMD will be measured 3 times (baseline, 12 months and 24 months) on this study. Study blood work is obtained three times (baseline, 6 months, and 12 months). Blood (about 3 teaspoons).
12000484|NCT00587899|Procedure|Pulmonary Vein Isolation|The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
12000485|NCT00587886|Behavioral|Questionnaire|The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.
12000486|NCT00587886|Behavioral|Questionnaire|"The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.
~We will conduct interviews mainly by telephone but also in person (at home or another convenient place)if the participant prefers."
12000487|NCT00587873|Drug|Methotrexate|MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion
12000488|NCT00587873|Drug|Leucovorin calcium|5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.
12000489|NCT00587873|Drug|6-Thioguanine|6-TG 300 mg/m2 PO as a single oral dose
12000490|NCT00587860|Drug|St. John's wort|Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
12000491|NCT00587860|Drug|Placebo|Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
12000492|NCT00587847|Drug|Campath|Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
12000493|NCT00587834|Device|Gintuit|Application of Gintuit at Day 0 to the gingival bed
12000494|NCT00587834|Other|Autologous palatal tissue|Tissue will be harvested from the subject's palate and placed on the gingival bed
12000495|NCT00587821|Other|Blood draw|Peptide profiles from blood samples of all subjects will be determined by mass spectrometric analysis.
12000496|NCT00587808|Procedure|RHC with VO2 consumption|All pressure-volume data is acquired at 250 Hz and stored on the Leycom system for offline analysis. Volume data will be calibrated using the most recent EF from echocardiogram and stroke volume from the Fick method. Measured O2 consumption will be utilized along with sampling of SVC and arterial blood oximetry to determine cardiac output at rest and during exercise
12000497|NCT00587795|Device|StabilAir Wrist Brace|Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.
12000498|NCT00587795|Other|Placement of sugar tong splint or plaster cast|Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.
12000499|NCT00587769|Drug|Bupropion SR & Varenicline|"Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day.
~Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment."
12000500|NCT00587756|Procedure|One-stage ultrasound guided hepatectomy|Surgical strategy was based on tumor-vessel relationship at intraoperative ultrasonography (IOUS)and on findings at color-Doppler IOUS.
12000501|NCT00587730|Device|GE Attenuation Corrected Hawkeye Camera|GE Hawkeye AC system and 360˚ camera orbit
12000502|NCT00587717|Drug|simvastatin|Two 80 mg pills simvastatin taken 24 hours prior to surgery
12000503|NCT00587717|Drug|placebo|take 2 80 mg pills placebo 24 hours prior to surgery
12000504|NCT00587704|Procedure|PVB using nerve stimulation|5ml of 1% ropivacaine injected incrementally
12000505|NCT00587704|Procedure|PVB using anatomic landmarks|5ml of 1% ropivacaine injected incrementally
12000506|NCT00587691|Biological|Tovaxin Autologous T Cell Vaccine|"Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period.
~Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods.
~Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods."
12000507|NCT00587678|Drug|Simvastatin|40mg each night
12000508|NCT00587678|Drug|Ezetimibe|10mg daily
12000509|NCT00587678|Drug|Simvastatin/Ezetimibe|40mg/10mg each night
12000510|NCT00587665|Drug|ketamine|Single IV dose of 0.1 mg/kg of ketamine
12000511|NCT00587665|Drug|Placebo|Saline given of equal volume to drug
12000512|NCT00587639|Device|rTMS Treatment|Active rTMS treatment.
12000513|NCT00587626|Device|Inactive InterX 5000|Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
12000514|NCT00587626|Device|InterX 5000 Treatment|Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
12000515|NCT00587600|Procedure|Photodynamic therapy|Photofrin 2mg/kg Photoradiation The light dose delivered will be a total of 200 joules per centimeter fiber which has previously been shown to ablate Barrett's mucosa.
12000516|NCT00587600|Procedure|radiofrequency ablation of barrett's esophagus|radiofrequency ablation
12000517|NCT00587587|Device|Apligraf|Application at Day 0, potential re-application at Week 4
12000518|NCT00587587|Other|Standard dressing regimen|A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary
12000654|NCT00586430|Drug|lorazepam|single 2 mg dose of lorazepam
12000522|NCT00587522|Device|NDO Full-thickness Plicator|The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument.
12000523|NCT00587496|Drug|valacyclovir hydrochloride|500 mg capsule, one per day for 30 days
12000524|NCT00587496|Drug|placebo|lactose placebo capsule, six per day for 30 days
12000525|NCT00587496|Drug|valacyclovir plus aspirin|500 mg valacyclovir capsule, one per day for 30 days 325 mg acetyl salicylic acid (aspirin) capsule, three per day for 30 days placebo capsule, two per day for 30 days
12000526|NCT00587483|Drug|Lidocaine|Lidocaine is a class I (sodium channel block) antiarrhythmic drug
12000527|NCT00587483|Drug|Amiodarone|300 mg
12000528|NCT00587483|Drug|Placebo|Saline
12000529|NCT00587470|Drug|Candesartan|Maximum vasodilation.
12000530|NCT00587470|Drug|atacand|maximum vasodilation
12000531|NCT00587470|Drug|Placebo|Placebo
12000532|NCT00587457|Drug|CAT-8015 5 mcg/kg|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
12000533|NCT00587457|Drug|CAT-8015 10 mcg/kg|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
12000534|NCT00587457|Drug|CAT-8015 20 mcg/kg|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
12000535|NCT00587444|Drug|Heparin|300u/kg of heparin for CPB ACT performed. If ACT is < 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is>480 seconds
12000536|NCT00587444|Drug|HH or high heparin|initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB
12000537|NCT00587444|Drug|heparin concentration HC|"will have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB.
~All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10%"
12000538|NCT00587431|Drug|GnRh (Leuprolide)|Leuprolide LUPRON
12000539|NCT00587431|Drug|Testosterone Gel|Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
12000540|NCT00587431|Drug|Docetaxel|70 mg/m2 given on day o1 of each 3 week cycle
12000541|NCT00587418|Dietary Supplement|L-arginine|Arginaid (Novartis) 1 package (9.2g) bid for 7 days
12000542|NCT00587418|Dietary Supplement|Placebo|Placebo powder 9.2g bid for 7 days
12000543|NCT00587405|Procedure|cryotherapy|"The Polar Wand device (GI Supply, Wayne, PA) is FDA 510(k) approved for endoscopic tissue ablation in the GI tract. It consists of a portable cryogen-containing unit and a single-use flexible cryogen spray catheter, designed for use with CO2 that is supplied in standard 20-lb cylinders. Controlled delivery of the cryogen is achieved by a foot pedal, and the tip of the catheter is maintained at about 1 cm from the mucosa. A cryogenic spray is applied to all vascular lesions until a whitened appearance of the mucosa is achieved within 3-5 seconds. Affected areas will be 'painted' by the spray catheter starting at the pylorus and sweeping proximally.
~A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy."
12000544|NCT00587405|Procedure|Argon Plasma Coagulation|As per current clinical standard, the APC 300 device (ERBE Inc., Marietta, GA) will be used in this study. Targeted ablation of all vascular ectasias as best possible will be performed in standard fashion using an end-firing probe at a setting of 60 W and 2 L/min argon flow rate.A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy
12000545|NCT00587392|Device|NDO Full-thickness Plicator|The NDO Full-thickness Plicator intervention was performed as part of the original open-label Plicator study as previously reported. This intervention did not take place as part of this long-term follow-up data collection study.
12000546|NCT00587379|Drug|Atorvastatin|40 mg atorvastatin pill daily
12000547|NCT00587379|Drug|placebo|40 mg pill per day
12000548|NCT00587353|Other|Behavioral and pharmacologic tobacco use intervention|A novel approach to providing an intervention for tobacco users who are receiving radiation therapy is to provide an individual tobacco use intervention that utilizes concepts of motivational interviewing strategies to facilitate self-exploration of the reasons for continued smoking and a treatment plan that is comprehensive and builds self-efficacy, provides one-on-one counseling, and includes tobacco treatment pharmacotherapies. The pharmacotherapies will be tailored to the patients needs. One could utilize varenicline, bupropion, and/or nicotine replacement therapies.
12000549|NCT00587327|Drug|Barusiban|Solution for IV treatment. Bolus and infusion for 4 hours
12000550|NCT00587327|Drug|Atosiban|Solution for IV administration. Bolus and infusion for 4 hours
12000551|NCT00587327|Drug|Placebo|Saline solution for IV administration. Bolus and infusion for 4 hours.
12000552|NCT00587314|Other|Biopsy|Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus
12000553|NCT00587301|Device|Lap-Band|Obesity and adolescents
12000554|NCT00587288|Biological|Reslizumab|
12000555|NCT00587288|Other|Saline|
12000556|NCT00587275|Drug|AST-120|Oral, sachet, 2 grams daily for 4 weeks
12000557|NCT00587275|Drug|Celphere CP-305|Oral, sachet, 2 grams daily for 4 weeks
12000558|NCT00587249|Biological|Malaria ICC-1132|ICC-1132, a candidate malaria vaccine, with alhydrogel will be in 2 ml glass vials containing ICC-1132 at either 40 mcg/ml or 100 mcg/ml concentration formulated with alhydrogel at 1mg/ml. Each vial will contain approximately 0.8 ml solution to permit recovery of 0.5 ml for injection. When shaken, the solution is off-white to greyish-white turbid liquid free of foreign particulate matter.
12000559|NCT00587249|Biological|Alhydrogel|Aluminum hydroxide gel.
12000560|NCT00587223|Device|Apligraf|Up to 3 applications: Day 0, Month 1, Month 2.
12000561|NCT00587223|Other|Standard dressing regimen|Dressing regimen will be comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer
12000562|NCT00587171|Device|Patching|2 hours daily patching
12000563|NCT00587171|Procedure|Near activities|30 minutes daily near activities at home
12000564|NCT00587171|Procedure|Active vision therapy|30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session
12000565|NCT00587171|Procedure|Control vision therapy|30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session
12000566|NCT00587158|Drug|Paricalcitol|Zemplar® - this medicine, which is the medicine being studied, will be given as a capsule containing 1 microgram of Zemplar® once daily beginning the day after the transplant. It will be continued at the same dose for the first two weeks then, depending on the results of blood and urine testing, will be increased to 2 micrograms daily. The dose will remain at 2 micrograms daily until the end of the study unless there is a medical reason to reduce or stop it or unless the study is stopped early.
12000567|NCT00587158|Other|Corticosteroid Avoidance Immune Suppression Protocol|Induction with Alemtuzumab and maintenance with Tacrolimus and Mycophenolate Mofetil. With standard antimicrobial prophylaxis and calcium supplementation.
12000568|NCT00587145|Drug|S-1,Docetaxel|"S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
~Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8"
12000569|NCT00587132|Drug|Synthetic Human Secretin|0.2mcg/kg one time dose.
12000570|NCT00587119|Drug|Budesonide|Oral Budesonide, 3 mg three times daily, will be given for 1 year.
12000571|NCT00587093|Other|CA 125 and CT scan|Within 14 days prior to surgery serum for CA125 will be obtained. The patient will also undergo a CT scan of the abdomen and pelvis with oral and intravenous contrast within 35 days prior to the procedure.
12000572|NCT00587067|Drug|FLOXURIDINE|"[0.16* mg/kg/day X 30 ml] / pump flow rate
~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
12000573|NCT00587054|Drug|cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant|"Myeloablative and will consist of hyperfractionated TBI - 1375 cGy administered in 11 doses of 125 cGy each over a total of four days, with three doses on three days and two doses on the last day, fludarabine 25 mg/m2 IV x 5 days, and thiotepa 5mg/kg IV x 2 days. Recipients of HLA identical related transplants will not receive ATG to promote engraftment. Recipients of HLA mismatched related or unrelated stem cells will receive ATG for two days prior to the transplant. G-CSF mobilized CD34+E- PBSCs obtained from the HLA compatible donor will be infused on day 0. Post transplantation G-CSF will be administered only if clinically indicated and should begin on or after d+7.
~Patients will be clinically evaluated at each clinic visit for incidence and severity of acute and chronic GVHD and transplant associated morbidity. Sequential evaluation of functional reconstitution of hematopoiesis and immunity will be made as per the BMT Service guidelines."
12000574|NCT00587041|Dietary Supplement|Oxadrop|Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis).
12000575|NCT00587041|Dietary Supplement|Agri-King Synbiotic (AKSB)|AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
12000576|NCT00587041|Other|Placebo|1 placebo packet daily and 1 placebo capsule twice daily
12000577|NCT00587015|Drug|CAT-8015|The dose level of the initial cohort will be 5 μg/kg so cohorts will be dosed at 5, 10, 20, 30, 40, 50, 60…μg/kg until toxicity supervenes.
12000578|NCT00587002|Procedure|IVUS|Intravascular ultrasound with virtual histology
12000579|NCT00586989|Procedure|Upper endoscopy with biopsy|Endoscopy with biopsy 6 weeks after the initial endoscopy
12000580|NCT00586976|Drug|Ropivacaine|0.3% ropivacaine infusion at 4 ml/hr for 64 hours.
12000581|NCT00586976|Drug|Normal saline|Normal saline infusion at 4 ml/hour for 64 hours.
12000582|NCT00586937|Behavioral|questionnaires or telephone interview|In the first phase, a random sample of lung cancer survivors will complete a comprehensive telephone interview or questionnaire by self-report focusing on assessment of quality of life and related covariates. We estimate the total time for completion of the survey by telephone interview or self-report to be 45-60 minutes. second phase of the study, a subset of telephone survey participants will take part in a focus group discussion that will explore their perceptions of barriers for delivery of post-treatment medical and psychosocial follow-up care.
12000583|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 5 microgram per kilogram (mcg/kg) moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
12000584|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
12000585|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
12000586|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
12000587|NCT00586924|Drug|CAT 8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
12000588|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
12000589|NCT00586911|Drug|Cystadane|Betaine 20 mg a day or identical placebo for 1 year.
12000590|NCT00586911|Drug|Identical Placebo|Placebo
12000591|NCT00586898|Drug|GnRH|leuprolide and goserelin are gonadotropin-releasing hormone analogues
12000592|NCT00586898|Drug|Ketoconazole|An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
12000593|NCT00586898|Drug|Bicalutamide|A pure nonsteroidal antiandrogen
12000594|NCT00586898|Drug|Testosterone transdermal gel|an androgenic anabolic steroid
12000595|NCT00586898|Drug|Estrogen transdermal patch|Estradiol is the primary and most potent estrogen
12000596|NCT00586885|Drug|L-alanine|6g of L-alanine (powder)once per day for the first month, twice per day for the second month, then three times per day from the third month for 10 months.
12000597|NCT00586859|Device|NDO Full-thickness Plicator|The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument. Additional sutures were placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. All plications were placed de novo, and re-treatment was not permitted.
12000598|NCT00586846|Drug|Cisplatin|Cisplatin 120 mg/m^2
12000599|NCT00586846|Drug|Doxorubicin|75mg/m^2
12000600|NCT00586846|Drug|Methotrexate|Methotrexate 12g/m^2
12000601|NCT00586833|Procedure|O2 consumption max bike test|Single visit exercise study
12000602|NCT00586820|Drug|BQ-123|BQ-123 is a cyclic peptide consisting of five amino acids. BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
12000603|NCT00586820|Drug|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
12000604|NCT00586807|Other|Stable amino acid isotopes|Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.
12000605|NCT00586794|Drug|Sildenafil|3x per day 20 mg TID
12000606|NCT00586794|Drug|Placebo|3x per day, 20 mg TID
12000607|NCT00586781|Device|Scandinavian Total Ankle Replacement (STAR)|The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.
12000608|NCT00586755|Procedure|Intensive Induction-BMT|Patients will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2 intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d intravenously over 30 minutes daily on days 1, 2, and 3). This will be combined with Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, subjects have not had progression of disease as noted on physical exam or radiographic scans, they will proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support. Following count recovery, rituximab will be used for 8 total doses as consolidation therapy. Involved field irradiation may be given post-transplant to those with localized bulky disease as well.
12000609|NCT00586742|Procedure|labral repair|labral repair with suture anchors
12000610|NCT00586742|Procedure|biceps tenodesis|biceps tenodesis with suture anchor
12000611|NCT00586742|Procedure|diagnostic arthroscopy|diagnostic arthroscopy
12000612|NCT00586729|Device|Vashe|Antimicrobial irrigant
12000613|NCT00586729|Drug|Mafenide acetate|Antimicrobial solution
12000614|NCT00586716|Drug|intravenous immune globulin|0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments
12000615|NCT00586703|Device|NK-CD56|NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
12000616|NCT00586690|Device|NK Cell infusion using CD56 monoclonal antibody|The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
12000655|NCT00586430|Drug|placebo|single dose of placebo
12000656|NCT00586417|Other|punch biopsy|skin biopsies
12000657|NCT00586391|Genetic|CD19CAR-28-zeta T cells|"Intravenous injection
~Dose Level 1:
~CD19CAR-28zeta - 2x10^7 cells/m^2
~Dose Level 2:
~CD19CAR-28zeta - 1 x10^8 cells/m^2
~Dose Level 3:
~CD19CAR-28zeta - 2x10^8 cells/m^2"
12000788|NCT00585221|Drug|Imatinib|Continue imatinib until progression.
12000617|NCT00586690|Procedure|Donor Apheresis|Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
12000618|NCT00586677|Behavioral|Parent-Child Interaction Therapy|Sixteen one hour sessions done in-home for children ages 2-7. Proceed through protocol based on mastery of predefined skills.
12000619|NCT00586677|Behavioral|Health and Safety|Sixteen one hour sessions for children age 0-7 conducted in the home. Participants are quizzed on material to determine mastery.
12000620|NCT00586677|Behavioral|Early Relationships|Sixteen one-hour sessions for children age 0-2 provided in-home.
12000621|NCT00586664|Drug|Bepreve (bepotastine besilate ophthalmic solution) 1.5%|sterile ophthalmic solution
12000622|NCT00586664|Drug|placebo comparator|sterile ophthalmic solution
12000623|NCT00586664|Drug|Bepotastine Besilate Ophthalmic Solution 1.0%|sterile ophthalmic solution
12000624|NCT00586651|Drug|lestaurtinib|60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
12000625|NCT00586638|Behavioral|Video game based training|36 one-hour sessions over 12 weeks
12000626|NCT00586625|Drug|Bepreve|One drop, both eyes, twice a day
12000627|NCT00586625|Drug|Placebo|One drop, both eyes, twice a day
12000628|NCT00586612|Biological|Menitorix™|Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
12000629|NCT00586612|Biological|Infanrix™ penta|Intramuscular injection, 3 doses in the primary study
12000630|NCT00586612|Biological|Prevenar™|Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
12000631|NCT00586612|Biological|Infanrix™ IPV|Intramuscular injection, 1 dose in the Booster study.
12000632|NCT00586599|Other|measurement of inflammatory markers|measuring inflammatory markers and comparing to controls.
12000633|NCT00586586|Behavioral|Cognitive behavioural therapy|The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
12000634|NCT00586573|Drug|memantine hydrochloride|tablet, 5-20 mg, twice daily, by mouth, 12 weeks
12000635|NCT00586560|Drug|Kareniticin and cyclophosphamide|"An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle).
~Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity."
12000636|NCT00586547|Biological|T-Cell Infusion Dose Level -1|(1 x 10^3 T cells/Kg)
12000637|NCT00586547|Biological|T-Cell Infusion Dose Level 1|(1 x 10^4 T cells/Kg)
12000638|NCT00586547|Biological|T-Cell Infusion Dose Level 2|(1 x 10^5 T cells/Kg)
12000639|NCT00586547|Biological|T-Cell Infusion Dose Level 3|(1 x 10^6 T cells/Kg)
12000640|NCT00586547|Biological|T-Cell Infusion- Dose Level 4|(5 x 10^6 T cells/Kg)
12000641|NCT00586534|Behavioral|I/GDC + VR/CER|NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment plus virtual reality (VR) based cue exposure/extinction software and cellular phone-based computerized extinction reminder (CER) technology for use in high-risk situations outside treatment sessions.
12000642|NCT00586534|Behavioral|I/GDC|NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment
12000643|NCT00586521|Drug|Kogenate (BAY14-2222)|One group two treatment schedules, first on-demand then switch to prophylaxis
12000644|NCT00586508|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).
12000645|NCT00586508|Drug|bevacizumab|10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).
12000646|NCT00586508|Drug|Enzyme-inducing antiepileptic drugs (EIAED)|Administered orally
12000647|NCT00586508|Drug|Non-enzyme inducing antiepileptic drugs (NEIAED)|Administered orally
12000648|NCT00586495|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
12000649|NCT00586482|Drug|Nicotine Lozenge|Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day and a 2 minute behavioral intervention. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
12000650|NCT00586482|Drug|Placebo Lozenge|Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day and a 2 minute behavioral intervention.
12000651|NCT00586482|Behavioral|Abstinence Advisement|A brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
12000652|NCT00586469|Biological|Fluviral|One dose, Intramuscular injection
12000653|NCT00586443|Drug|bevacizumab, everolimus, panitumumab|"Cohort # subjects Bevacizumab Everolimus Panitumumab
~3 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 3.6 mg/kg IV Q2 weeks
~2 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 4.8 mg/kg IV Q2 weeks
~1 3-6 10 mg/kg IV Q2 weeks 5 mg PO QD 4.8 mg/kg IV Q2 weeks
~3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 4.8 mg/kg IV Q2 weeks
~3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 6 mg/kg IV Q2 weeks 3a 10 RPTD* RPTD* RPTD* 3b 10 RPTD** RPTD** RPTD**
~Panitumumab and RAD001 started on Day 1, bevacizumab started on Day 15. **Bevacizumab and RAD001 started on Day 1, panitumumab started on Day 15."
12000658|NCT00586391|Drug|Ipilimumab|For patients with intermediate or low grade leukemia/lymphoma, patients may receive ipilimumab once during the week 2 visit after the T cell infusion.
12000659|NCT00586378|Device|Ovatio DR and Ovatio VR|implantable cardioverter defibrillator
12000660|NCT00586365|Drug|Naproxen|500 mg Naproxen twice a day for two weeks
12000661|NCT00586352|Other|stable isotope infusions|Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.
12000662|NCT00586339|Biological|Cervarix|Intramuscular injection, 3 doses
12000663|NCT00586339|Biological|Placebo Control|Intramuscular injection, 3 doses
12000664|NCT00586326|Device|MammoSite Radiation Therapy System|The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.
12000665|NCT00586313|Device|Tru-cut biopsy|Tru-cut biopsy may be an alternative to percutaneous and transjugular liver biopsy.
12000666|NCT00586313|Procedure|Tru-cut|Tru-cut may be an alternative to percutaneous and transjugular liver biopsy.
12000667|NCT00586300|Other|Physical training program|The physical training will be completed in two phases. In Phase 1, which will last 9 months, participants will complete the program under the supervision of an experienced trainer. Sessions will occur three times each week in a designated study facility. The program will include the following components: stretching and balance, flexibility and range of motion, muscle strengthening, and aerobics. The program will also emphasize the importance of individualizing exercise regimens according to each person's specific needs (function and fitness). In Phase 2, the primary objective will be to promote long-term exercise (for up to 24 months from the time of study entry) that incorporates the four modalities of exercise instruction introduced in Phase 1, but on an independent basis.
12000668|NCT00586300|Behavioral|Self-management training program|The self-management training program is designed to target primarily coping skills and self-efficacy. This will be accomplished by using a variety of educational and behavioral methods. The program will be delivered in two phases. The initial 9-month phase will consist of 12 weekly 60-minute classroom sessions, followed by 24 weeks of a structured telephone intervention program. Phase 2 will continue to incorporate the telephone intervention program, at less frequent intervals, for up to 24 months from the time of study entry.
12000669|NCT00586300|Other|Physical training and self-management training programs|"This multidimensional intervention will combine both the physical training and self-management training programs described for Groups 1 and 2."
12000670|NCT00586287|Other|Algorithm for phenprocoumon|Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm A published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.)
12000671|NCT00586287|Other|algorithm for phenprocoumon|Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm B published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.)
12000672|NCT00586287|Drug|Phenprocoumon|Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician
12000673|NCT00586274|Procedure|CD34 selected haploidentical PBSCT|Infusion of CD34 selected haploidentical PBSCT
12000674|NCT00586274|Drug|Fludarabine|day -8 through day -4 Fludarabine 30 mg/m^2
12000675|NCT00586274|Biological|T cell infusion|"At least 30 days after the stem cell infusion, patients will be dosed with T cells. This study will begin with a dose of T cells known not to cause GvHD even in haploidentical recipients, even when the T cells administered have not first been allodepleted. Dose escalation will follow a traditional up and down method, but as results become available they will be used to determine subsequent dose levels by the continual reassessment method. Initially, 2 patients will be entered beginning at dose level 1. Each and every patient will receive up to three additional injections of T cells at the same dose, at monthly intervals, provided there is no evidence of grade 2 or higher GVHD, until total T cell numbers are > 1000/ul.
~Dose level -1 (1 x 10^3 T cells/Kg); Dose level 1 (1 x 10^4 T cells/Kg); Dose level 2 (1 x 10^5 T cells/Kg); Dose level 3 (1 x 10^6 T cells/Kg); Dose level 4 (5 x 10^6 T cells/Kg)"
12000676|NCT00586274|Biological|Campath 1h|10 mg iv over 4 hours day-8 through day-6
12000677|NCT00586274|Biological|anti-CD45|anti-CD45 400 ug/kg over 6 hours day -5 through day -2
12000678|NCT00586261|Drug|Pioglitazone|Pioglitazone 30 mg daily for 6 months
12000679|NCT00586261|Drug|Placebo|Placebo 30 mg daily for 6 months
12000680|NCT00586261|Drug|Nitroglycerin|0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity.
12000681|NCT00586222|Dietary Supplement|Omega-3 Fatty Acid|600 mg of eicosapentaenoic acid, 340 g of docosahexanoic acid, and 96 mg gama-linoleic acid for 12 weeks.
12000682|NCT00586222|Other|Placebo|placebo pill of the same size, color, and shape as the dietary supplement.
12000683|NCT00586209|Drug|L-Glutamine|L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg)
12000684|NCT00586209|Drug|Placebo|Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine
12000685|NCT00586196|Drug|donepezil|5 mg each day for 30 days
12000686|NCT00586196|Drug|Placebo|Encapsulated cornstarch One capsule daily for 30 days
12000687|NCT00586183|Procedure|PET scan|The subject will then be positioned in the PET scanner . After optimal positioning of the left ventricle within the field of view, a transmission scan will be performed with either a germanium-68 or CT source for subsequent attenuation correction.
12000688|NCT00586170|Device|EBI Bone Healing System|10 hours of treatment per day for up to 24 weeks
12000689|NCT00586170|Device|Placebo Device|10 hours of treatment per day for up to 24 weeks
12000690|NCT00586170|Procedure|Surgery|Open Reduction and Internal Fixation of the nonunion site
12000691|NCT00586157|Drug|Methylphenidate Transdermal System|Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)
12000692|NCT00586157|Drug|Placebo|Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)
12000693|NCT00586131|Drug|ammonium chloride or sodium citrate/citric acid|Dose dictated by changes in pH
12000694|NCT00586131|Drug|Sodium citrate/citratic acid|dictated by pH
12000695|NCT00586118|Drug|Sevoflurane|Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU
12000697|NCT00586105|Drug|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
12000698|NCT00586092|Drug|bevacizumab, ABT-510|"Stage 1 (Cohorts -1, 2, 2, 3) ABT-510: 25, 50, 50, 100 mg SC BID*, bevacizumab: 5, 5, 10, 10 mg/kg IV every 14 days*
~Stage 2 (RPTD) ABT-510: X mg SC BID**, bevacizumab: Y mg/kg IV every 14 days**
~Stage I is the dose escalation stage. Stage II will include an additional 20 patients (10 patients in each group) enrolled at the RPTD in two different schedules to better assess safety and biomarker correlates.
~*Both agents begin on Day 1 of Cycle 1.
~**At the RPTD, ½ the patients will begin ABT-510 (Dose X) on Day 1 and bevacizumab (Dose Y) on Day 15 and the other ½ of the patients will begin bevacizumab on Day 1 and ABT-510 on Day 15. This will allow for a collection of some preliminary data of wound angiogenesis effects of ABT-510 alone versus the combination and bevacizumab alone versus the combination."
12000699|NCT00586079|Procedure|Deep brain stimulation surgery.|Deep brain stimulation surgery.
12000700|NCT00586066|Drug|Memantine|Week 0: 5 mg memantine or placebo once a day (q.d.) Week 1: 5 mg memantine or placebo twice a day (b.i.d.) Week 2-3: 5 mg memantine or placebo once in the morning (q.a.m.)/10 mg once in the evening (q.p.m.) Week 4-12: 10mg Memantine or placebo b.i.d.
12000701|NCT00586066|Drug|Placebo|Inactive comparator. Placebo-matching memantine tablet.
12000702|NCT00586040|Procedure|tissue bonding|application of rose bengal and treatment with green light
12000703|NCT00586040|Procedure|sutures|interrupted superficial sutures
12000704|NCT00586014|Procedure|High-Dose Sequential Chemotherapy followed by ASCT|Patient will receive Cyclophosphamide(4 g/m2 over 2 hours) and blood progenitor cell collection (day -49). G-CSF (10 mcg/kg/d) will be administered SQ. A six hour leukapheresis will be performed,cells will undergo CD34+ cell selection, patients will receive high dose VP-16 (Etopophos)(day -28)(2 g/m2 over 4 hours)and G-CSF (5 mcg/kg/d) will be administered SQ two days following VP-16. The an IV of sulfamethoxazole-trimethoprim 1 ampule BID for 5 days (Day -5). BCNU 500 mg/m2 IV over 2 hours (Day -4). Melphalan (Day -2) will be administered IV (200 mg/m2 over 20 minutes). The frozen peripheral blood mononuclear cells will be transfused on Day 0. Day +1: G-CSF 5 mcg/kg/d SQ for 3 days.
12000705|NCT00586001|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|Cognitive-behavioral treatment in development for emotional disorders
12000706|NCT00585988|Device|Hip Resurfacing System|This arm will utilize a hip resurfacing system.
12000707|NCT00585988|Device|M2a-Magnum™ Large Metal Articulation|This arm will utilize the M2a-Magnum™ implant system.
12000708|NCT00585975|Drug|bromfenac ophthalmic solution|sterile opthalmic solution
12000709|NCT00585962|Radiation|Proton Beam Radiation|Once a day, 5 days a week (Monday-Friday), for 8 weeks.
12000710|NCT00585949|Procedure|Percutaneous Coronary Angioplasty|This is a procedure by which the blood vessels of the heart are imaged with an insertion of a catheter in the groin and blocked arteries are opened.
12000711|NCT00585949|Procedure|Angiography|Angiography is an imaging technique to see coronary blood vessels.
12000712|NCT00585923|Device|Fixed hole C-Tek™ Plate|Fixed hole C-Tek™ Plate
12000713|NCT00585923|Device|Slotted hole C-Tek™ Plate|Slotted hole C-Tek™ Plate
12000714|NCT00585910|Drug|Atomoxetine and OROS Methylphenidate|Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.
12000715|NCT00585897|Behavioral|discontinuation of sugar sweetened beverages|Individual sessions which utilize motivational interviewing to assist participants to eliminate sugar sweetened beverages from their diet.
12000716|NCT00585871|Drug|clonidine|0.1 mg tid
12000717|NCT00585871|Drug|metoprolol|25 mg tid
12000718|NCT00585845|Biological|CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin|2-hour IV infusion once every 21 days, up to 4 doses. Doses from 1x10^8 cfu to 1x10^10 cfu.
12000719|NCT00585832|Behavioral|DASH-4-Teens|24-week behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy foods and that is low in fat and sodium
12000720|NCT00585832|Other|Routine Care|individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program.
12000721|NCT00585819|Procedure|reproduce breathing cycle utilizing spirometry|reproduce breathing cycle utilizing spirometry
12000722|NCT00585819|Procedure|Freebreathing in Body fix mold|Freebreathing in Body fix mold
12000723|NCT00585793|Drug|NRTI/NNRTI/ Kaletra|Fixed dose and cild formulation Kaletra
12000724|NCT00585780|Drug|Prazosin Tablet|Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.The titration schedule was as follows: 1 mg dose at bedtime for 2 nights, followed by a 1mg dose morning and night (8 AM/8 PM) on day 3, then 2 mg dose t.i.d., on days 4-6, 3 mg dose (2 pills each) morning and afternoon, and 4 mg dose (2 pills) at night for days 7-9, increased to 4 mg dosing t.i.d. on days 10-13, and from day 14 through week 11, 5 mg (1 pill) each in the morning and afternoon, and 6 mg for the night (2 pills) dose. This was followed by a 5-day taper in week 12. Patients were initiated on study medication upon presenting with a negative breathalyzer without any minimum pre-treatment alcohol abstinence period prior to medication initiation.
12000725|NCT00585780|Drug|Placebo Tablet|Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized
12000726|NCT00585754|Drug|Guanfacine|1.5mg BID
12000727|NCT00585754|Drug|Placebo|placebo
12000728|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
12000729|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
12000730|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
12000731|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
12000732|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
12000733|NCT00585728|Procedure|CT Virtual Proctoscopy (CTVP)|CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.
12000734|NCT00585715|Device|1064 nm Nd:YAG laser|3 treatments at 3-5 week intervals Spot size: 10 - 18 mm diameter Fluence: 50 J/cm2 Laser pulse duration: 50 ms Rep. rate: Up to 2 Hz DCD cooling 0-50 ms
12000789|NCT00585208|Drug|Ramelteon|Ramelteon 8mg daily
12000735|NCT00585689|Drug|ABI-007|ABI-007 will be administered at a dose of 260 mg/m2 over a 30 min IV infusion on day 1 of each 21 day cycle.
12000736|NCT00585689|Drug|Carboplatin|Carboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle.
12000737|NCT00585689|Drug|Gemcitabine|Gemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle.
12000738|NCT00585689|Procedure|Radical Cystectomy|
12000739|NCT00585650|Biological|Etanercept|Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.
12000740|NCT00585650|Other|Placebo injections|Placebo injections twice weekly for 12 weeks.
12000741|NCT00585637|Drug|Vitamin D|Taken orally every day for three months
12000742|NCT00585637|Dietary Supplement|Placebo|Placebo pill taken once daily for 3 month
12000743|NCT00585624|Dietary Supplement|Impact Advanced Recovery|Nutritional supplement
12000744|NCT00585624|Dietary Supplement|No supplement|No supplement
12000745|NCT00585611|Drug|Atorvastatin|Atorvastatin - 40 mg orally daily for 6 months
12000746|NCT00585611|Other|placebo|placebo
12000747|NCT00585598|Other|replacing supralaryngeal airway with ET tube|changing tube in trauma bay
12000748|NCT00585585|Drug|betahistine dihydrochloride|oral, 50-300 mg, daily
12000749|NCT00585559|Drug|Placebos for acetaminophen and N-acetylcysteine|Placebos for acetaminophen and N-acetylcysteine
12000750|NCT00585559|Drug|APAP 1 gm every 6 hours and N-acetylcysteine placebo|Acetaminophen 1 gm every 6 hours and N-acetylcysteine placebo
12000751|NCT00585559|Drug|NAC IV infusion at 0.5 gm hourly and APAP placebo|N-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo
12000752|NCT00585559|Drug|APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly|Acetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
12000753|NCT00585559|Drug|APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly|Acetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
12000754|NCT00585546|Drug|clenbuterol|Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
12000755|NCT00585533|Drug|Erlotinib (Tarceva)|Erlotinib
12000756|NCT00585520|Drug|Progesterone|200mg BID for 5 days
12000757|NCT00585520|Drug|Placebo|Placebo
12000758|NCT00585507|Drug|Fulvestrant|500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.
12000759|NCT00585481|Procedure|Samples collection for viral diagnosis|"At Enrollment and Termination Visits all subjects will have phlebotomy performed for RSV antibody levels (3 mL of blood).
~Subjects diagnosed with an LRTI during the study will have a nasopharyngeal lavage (NPL) for viral diagnosis. Phlebotomy for antibody levels will be performed if the current episode represents the first LRTI since study enrollment."
12000760|NCT00585481|Procedure|Lung Function Analysis|Subjects enrolled in one study site (located in Porto Alegre city) will perform Lung Function Analysis. First measurement will be performed up to Visit 6 and repeated at Termination Visit. Measurements collected in the first analysis will include respiratory compliance and resistance by passive deflation pressure - volume curve, lung volumes by gas dilution method (washout with SF6), lung clearance index with SF6, and maximal flows (rapid thoracic compression from raised volumes).
12000761|NCT00585468|Drug|Myfortic|Myfortic 720 mg orally twice daily
12000762|NCT00585455|Drug|sertraline|open label 25-50 mg daily as tolerated
12000763|NCT00585442|Drug|calcitriol|1.0 mcg daily
12000764|NCT00585442|Drug|Placebo|Placebo
12000765|NCT00585416|Drug|CGC-11047|CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
12000766|NCT00585390|Dietary Supplement|Omega-3 Fatty Acids|"Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams
~Docosahexaenoic acid fish oil concentrate at 1.6 grams"
12000767|NCT00585390|Other|Olive oil placebo|Olive oil capsules, 8 capsules per day
12000768|NCT00585390|Dietary Supplement|EPA fish oil concentrate; DHA fish oil concentrate|3.2 grams for EPA 1.6 grams for DHA
12000769|NCT00585390|Drug|Placebo|Olive oil capsule
12000770|NCT00585377|Drug|Bevacizumab and Erlotinib|Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
12000771|NCT00585351|Drug|Ranitidine|50 mg single dose injection of Ranitidine
12000772|NCT00585351|Drug|Placebo|50 mg single dose injection of normal saline (placebo)
12000773|NCT00585351|Other|Advanced notification|Advanced notification of study via faxed consent to local Emergency Room (ER)
12000774|NCT00585351|Other|No advanced notification|No advanced notification of study via faxed consent to local Emergency Room (ER)
12000775|NCT00585338|Device|Tandem 532/1064 nm Laser|Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
12000776|NCT00585325|Drug|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
12000777|NCT00585325|Other|Placebo (0.9% Normal Saline)|.9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
12000778|NCT00585312|Drug|Celecoxib|celecoxib, 16 mg/kg/day, for 5 years
12000779|NCT00585312|Drug|Placebo|Masked, placebo comparator
12000780|NCT00585299|Other|Low-fat diet|20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks
12000781|NCT00585299|Other|Traditional diet|Traditional low-fat diet with dietitian follow-up in 16 weeks
12000782|NCT00585286|Device|10,600 nm fractional carbon dioxide laser system|1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
12000783|NCT00585260|Drug|mannitol|indirect mannitol challenge
12000784|NCT00585247|Drug|Imiquimod|Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
12000785|NCT00585247|Other|Placebo|Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
12000786|NCT00585234|Other|Digital Photography|Digital Photography
12000787|NCT00585221|Drug|Peginterferon-alpha 2b (PegIFNa2b);|Treatment include PegIFNa2b high dose (3 mcg/kg/wk) X 4 doses and low dose (1.5 mcg/kg/wk) X 18 doses, followed by surgical evaluation to render pt disease free if possible.
12000790|NCT00585208|Drug|Placebo|matching placebo for ramelteon 8mg daily
12000791|NCT00585195|Drug|PF-02341066|Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days (or 21 days depending on the cohort).
12000792|NCT00585195|Drug|Rifampin|600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.
12000793|NCT00585195|Drug|Itraconazole|Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.
12000794|NCT00585182|Drug|Enoxaparin 0.5 mg/kg once daily|Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.
12000795|NCT00585169|Drug|Memantine Hydrochloride|10 mg/day for two weeks, dose increase to 20 mg at week 3, 30 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.
12000796|NCT00585156|Drug|Celecoxib|Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.
12000797|NCT00585143|Drug|ABT-335|45 mg once daily for 10 consecutive days
12000798|NCT00585143|Drug|Rosuvastatin|10 mg once daily for 10 days
12000799|NCT00585117|Procedure|PET-imaging with CuATSM|imaging with CuATSM
12000800|NCT00585117|Procedure|PET Imaging|Imaging with CuATSM
12000801|NCT00585117|Procedure|PET CuATSM|Imaging with CuATSM
12000802|NCT00585117|Procedure|PET imaging|imaging with CuATSM
12000803|NCT00585117|Procedure|PET imaging with CuATSM|Imaging with CuATSM
12000804|NCT00585117|Procedure|PET imaging with CuATSM|Imaging with CuATSM
12000805|NCT00585104|Drug|levosimendan|10-minute infusion
12000806|NCT00585091|Drug|phenylephrine|All patients undergo repeated phenylephrine infusions during standard up-titration and maintenance of carvedilol treatment.
12000807|NCT00585078|Drug|Capecitabine|
12000808|NCT00585078|Drug|Oxaliplatin|
12000809|NCT00585065|Other|Cardiac Resynchronization Therapy|Cardiac Resynchronization Therapy
12000810|NCT00585052|Drug|Paclitaxel|Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
12000811|NCT00585052|Drug|Lovastatin|Lovastatin, 80 mg, po, daily will be self-administered by the subject.
12000812|NCT00585039|Drug|xopenex|will receive xopenex rather than albuterol to treat acute exacerbation
12000813|NCT00585026|Device|D-28 bifocal lenses and frame|
12000814|NCT00585026|Device|Progressive addition computer lenses and frame|
12000815|NCT00585013|Drug|Nitric Oxide|Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
12000816|NCT00585000|Drug|CP-675,206|15 mg/kg. IV (in the vein) over 1 hour on Day 1 of each 90 day cycle. Number of cycles: maximum of 4 cycles unless progression of disease or unacceptable toxicity.
12000817|NCT00584987|Drug|Fluticasone furoate|2 puffs of each nasal spray in each nostril in the pm
12000818|NCT00584987|Drug|Placebo Fluticasone furoate|2 puffs of each nasal spray in each nostril in the pm
12000819|NCT00584987|Drug|Oxymetazoline|2 puffs of each nasal spray in each nostril in the pm
12000820|NCT00584987|Drug|Placebo Oxymetazoline|2 puffs of each nasal spray in each nostril in the pm
12000821|NCT00584974|Drug|SEP-225289|0.5 mg SEP-225289
12000822|NCT00584974|Drug|SEP-225289|2.0 mg SEP-225289
12000823|NCT00584974|Drug|Venlafaxine|150 mg Venlafaxine
12000824|NCT00584974|Drug|placebo|Placebo
12000825|NCT00584961|Other|non-interventional|non-interventional
12000826|NCT00584948|Drug|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
12000827|NCT00584948|Drug|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
12000828|NCT00584935|Drug|Rituximab|The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).
12000829|NCT00584922|Procedure|Endoscopy in group I (all patients)|Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
12000830|NCT00584909|Drug|Paclitaxel and carboplatin combination|Paclitaxel will be administered at an appropriate dose (175 mg/m2) as a 3-hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing the Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate (GFR).
12000831|NCT00584896|Drug|PB127 for Injectable Suspension|0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.
12000832|NCT00584883|Drug|ABT 510|ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved.
12000833|NCT00584870|Drug|Naproxen|Oral naproxen 500 mg twice daily for Weeks 1-12.
12000834|NCT00584870|Drug|Placebo|Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
12000835|NCT00584870|Drug|PF-04383119 (RN624)|Single IV infusion of 200 micrograms/kg RN624 on Day 1
12000836|NCT00584857|Drug|Paclitaxel ,Carboplatin , Megesterol Acetate|Paclitaxel will be administered at an appropriate dose (175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at an anti-tumor dosage of 40 mg. This will be given for a total of 6 cycles over 18 weeks with the Megace continuing for 5 years as long as no evidence of recurrence is present.
12000837|NCT00584844|Biological|Live F tularensis Vaccine|Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).
12000838|NCT00584831|Device|senofilcon A|toric contact lens
12000839|NCT00584831|Device|balafilcon A|toric contact lens
12000840|NCT00584831|Device|omafilcon A|toric contact lens
12000841|NCT00584831|Device|lotrafilcon B|toric contact lens
12000842|NCT00584818|Drug|PB127 for Injectable Suspension|"Stages 1 & 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less.
~Stage 3 - will utilize infusion rate and dose established in Stages 1 & 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions."
12000843|NCT00584805|Biological|Inactivated, Dried, TSI-GSD 104, EEE|Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
12000844|NCT00584779|Drug|Gabapentin|CLcr:14-5 mL/min
12000845|NCT00584779|Drug|Gabapentin|CLcr: 29-15 mL/min
12000846|NCT00584779|Drug|Gabapentin|Hemodialysis
12000847|NCT00584779|Drug|Gabapentin|CLcr: 29-30 mL/min
12000848|NCT00584766|Procedure|High-dose chemotherapy|Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days
12000849|NCT00584753|Radiation|Positron emission tomography and computed tomography|Positron emission tomography and computed tomography
12000850|NCT00584753|Radiation|Positron emission tomography and computed tomography|Positron emission tomography and computed tomography
12000851|NCT00584753|Radiation|Positron emission tomography and computed tomography|Positron emission tomography and computed tomography
12000852|NCT00584740|Drug|AIN457|10 mg/kg
12000853|NCT00584740|Drug|Placebo|Matching placebo to AIN457
12000854|NCT00584727|Device|senofilcon A toric contact lens|contact lens
12000855|NCT00584727|Device|alphafilcon A toric|contact lens
12000856|NCT00584727|Device|etafilcon A sphere|contact lens
12000857|NCT00584701|Drug|Risperidone|Dose will start at 0.5 mg and may be increased throughout the course of the study if no adverse events occur
12000858|NCT00584688|Drug|quetiapine|quetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours.
12000859|NCT00584675|Device|Dx-pH Measurement Probe|Dx-pH Measurement Probe measures gaseous pH values in the nasopharynx and oropharynx over a period of 24 hours.
12000860|NCT00584662|Drug|Oxymetazoline Hydrochloride|Oxymetazoline Hydrochloride TWO SPRAYS BID
12000861|NCT00584649|Procedure|electrophysiology study and radiofrequency ablation|stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart
12000862|NCT00584636|Drug|pulmicort respules|pulmicort respules 0.5 mg twice a day for 28 days versus placebo
12000863|NCT00584610|Device|Levonorgestrel-containing IUD (Mirena®)|Levonorgestrel-containing intrauterine device insertion
12000864|NCT00584610|Device|Copper-containing IUD (Paraguard®)|Copper-containing intrauterine device insertion
12000865|NCT00584597|Drug|Saline|Saline Control
12000866|NCT00584597|Drug|Traumeel S|Traumeel S 1 mL
12000867|NCT00584597|Drug|Traumeel S|Traumeel S 2mL
12000868|NCT00584597|Drug|Traumeel S|Traumeel S 3mL
12000869|NCT00584584|Drug|QAX576|
12000870|NCT00584584|Drug|Placebo|
12000871|NCT00584571|Procedure|Sensory Adaptation Training|This study will last for approximately 3 months and will include 4-6 clinic visits with each visit lasting 2 hours every week or every 2 weeks. At the beginning of each visit we will ask you about your health status and level of satisfaction of your bowel habits. We will then place the pencil-thick probe and balloon inside your rectum and attach it to the barostat device and a computer. We will increase and decrease the volumes of the balloon until the most pressure you can tolerate or a certain level of pressure as measured by the machine is reached, whichever occurs first. You will continue to keep stool diaries and pain diaries for 7 days before and after each visit.
12000872|NCT00584571|Drug|Escitalopram Therapy|Escitalopram; 10 mg every day, orally.
12000873|NCT00584558|Procedure|Catheter Ablation|Catheter Ablation of arrhythmias
12000874|NCT00584532|Drug|Placebo|10 Placebo Capsules taken orally every day.
12000875|NCT00584532|Drug|GCP - Genistein Combined Polysaccharide|Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
12000876|NCT00584519|Other|non-interventional|non-interventional
12000877|NCT00584493|Drug|CP-675,206|"This is a single arm study. Patients will receive intravenous administration of CP-675,206 at a dose of 15 mg/kg on Day 1 of every 90-day cycle for up to 4 cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 (± 4 day) period. Patients who discontinue treatment after 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 2 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma
~Survival in this study will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206."
12000878|NCT00584480|Other|Hyperbaric Oxygen Treatment (HBOT)|1.5 ATA at 100% Oxygen of HBOT
12000879|NCT00584454|Biological|Q Fever Vaccine (NDBR 105|Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study.
12000880|NCT00584428|Procedure|High-Dose Chemo with Autologous BMT|Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70
12000881|NCT00584415|Device|GP ablation + PV isolation|All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
12000882|NCT00584402|Drug|perflutren lipid microspheres|perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
12000883|NCT00584389|Drug|rimonabant|20mg/d (oral) once daily for 12 weeks
12000884|NCT00584389|Behavioral|Dietary intervention|Dietary intervention to match weight loss in group 1. The energy prescription will be based on the estimate of the energy deficit estimated from the weight loss in group one. For example a weight loss of 5kg over 12 weeks equates to an approximate energy deficit of 30,000 kcal or a daily energy reduction of approximately 357 kcal. If this is achieved in group 1 the daily energy target for subjects in group 2 will be daily energy expenditure minus 357 kcal.For the subjects randomised to the dietary intervention group there will be a delay until group 1 subjects have completed the study.
12000885|NCT00584376|Drug|Pregabalin|Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
12000886|NCT00584376|Drug|Placebo|Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.
12000887|NCT00584350|Other|Hydratation according LVEDP + NaHCO3|"Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.
~At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours."
12000888|NCT00584350|Other|normal saline|hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).
12000889|NCT00584350|Other|Sodium bicarbonate|hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).
12000890|NCT00584324|Combination Product|BIS 40|"Mini-mental state exam: For subjects > 60, this exam will be administered pre-operatively.
~Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
~Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
~Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
~Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure."
12000891|NCT00584324|Combination Product|BIS 60|"Mini-mental state exam: For subjects > 60, this exam will be administered pre-operatively.
~Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
~Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
~Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
~Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure."
12000892|NCT00584311|Other|MRI and Ultrasound|MRI and US of the joint
12000893|NCT00584298|Drug|SMS995|
12000894|NCT00584298|Drug|Placebo|
12000895|NCT00584259|Other|Coffee|3 cups of coffee over a 24 hour period
12000896|NCT00584246|Drug|Pregabalin (Lyrica)|50 - 150 mg po qhs for 2 months
12000897|NCT00584246|Drug|Placebo|50 - 150 mg po qhs for 2 months
12000898|NCT00584233|Device|computed tomography|Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL).
12000899|NCT00584220|Device|senofilcon A toric|contact lens
12000900|NCT00584220|Device|alphafilcon A toric|contact lens
12000901|NCT00584207|Procedure|radiofrequency ablation|Intraoperative RFA of uterine fibroids
12000902|NCT00584194|Biological|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
12000903|NCT00584168|Drug|Dexamethasone|They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.
12000904|NCT00584168|Drug|Placebo|They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.
12000905|NCT00584155|Drug|Normal Saline and 0.3% ofloxacin|The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear and are only to be used in the designated ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.
12000906|NCT00584155|Drug|Lactated Ringer's with 0.03% Ofloxacin|The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.
12000907|NCT00584142|Behavioral|Mindfulness-Based Stress Reduction|MBSR is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. The intervention incorporates simple yoga, sitting meditation, body scan, and walking meditation in a 6-week program.
12000908|NCT00584129|Other|Pre-treatment swallowing exercises|Swallowing exercises will be started pre-treatment with radiation.
12000909|NCT00584129|Other|Post-treatment swallowing exercises.|Patients to start swallowing exercises after completion of radiation therapy.
12000910|NCT00584103|Device|Alpha P Control|Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.
12000911|NCT00584103|Device|Beta P Experimental|Subjects will be fitted with the inexpensive prosthesis model from Prestige Healthcare Technologies. Then the terminal device will be fitted and evaluated using the NYU trans-radial prosthesis checkout form.
12000912|NCT00584090|Drug|Solifenacin Succinate (VESIcare)|5 - 10 mg po qd for 1 month
12000913|NCT00584090|Drug|Placebo|Placebo equivalent of 5-10 mg po qd for 1 month
12000914|NCT00584064|Device|Device closure with the AMPLATZER PFO Occluder|Device closure with the AMPLATZER PFO Occluder
12000915|NCT00584038|Behavioral|educational instruction and phone follow-up|Educational instruction and phone follow-up.
12000916|NCT00584038|Behavioral|educational instruction in clinic|Educational instruction in clinic.
12000917|NCT00584025|Drug|levetiracetam|100 - 500mg IV q 15 min
12000918|NCT00584025|Drug|Placebo|Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min
12000919|NCT00584012|Drug|Lovastatin|Given PO
12000920|NCT00584012|Drug|Docetaxel|Given IV
12000921|NCT00583999|Other|no interventions, only regular blood-draw|No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)
12000922|NCT00583986|Drug|Levalbuterol HFA MDI with top mounted actuation indicator|Levalbuterol HFA MDA with top mounted actuation indicator
12000923|NCT00583947|Drug|arformoterol|Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
12000924|NCT00583947|Drug|levalbuterol|Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
12000925|NCT00583908|Device|senofilcon A|toric contact lens
12000926|NCT00583908|Device|balafilcon A toric|toric contact lens
12000927|NCT00583908|Device|lotrafilcon B toric|toric contact lens
12000928|NCT00583908|Device|omafilcon A|toric contact lens
12000929|NCT00583895|Drug|10% ImCOOH cream|Twenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15.
12000930|NCT00583895|Drug|Placebo|Five patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15.
12000931|NCT00583882|Other|Routine change of central venous catheters|Changeing CVCs on a regular basis to decrease infection rate.
12000932|NCT00583869|Drug|Placebo|"Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive a placebo PO BID beginning on the day of surgery until discharge.
~Upon discharge, the patient will be given study medication (placebo PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient."
12000933|NCT00583869|Drug|Pregabalin|"Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 75mg PO BID beginning on the day of surgery until discharge.
~Upon discharge, the patient will be given study medication (pregabalin 75mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient."
12000934|NCT00583869|Drug|Pregabalin|"Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 150mg PO BID beginning on the day of surgery until discharge.
~Upon discharge, the patient will be given study medication (pregabalin 150mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient."
12000935|NCT00583843|Procedure|Ultrasound|Ultrasound weekly during initial fields of radiation, and daily during the boost phase.
12000936|NCT00583830|Biological|Mapatumumab|30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
12000937|NCT00583830|Biological|Mapatumumab|10 mg/kg IV (in the vein), on day 1 of each 21 day cycle
12000938|NCT00583830|Drug|Paclitaxel|200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
12000939|NCT00583830|Drug|Carboplatin|AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
12000940|NCT00583817|Device|Endovascular stent-graft implantation|Endovascular repair of aorta
12000941|NCT00583804|Device|IST-12|Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
12000942|NCT00583791|Device|Device closure with the AMPLATZER Muscular VSD Occluder|Device: AMPLATZER Muscular VSD Occluder
12000943|NCT00583778|Drug|ipratropium|0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
12000944|NCT00583765|Drug|Regional citrate anticoagulation|Continuous venovenous hemodiafiltration with regional anticoagulation using dilute trisodium citrate. This requires the use of a continuous renal replacement therapy (CRRT) machine in venovenous hemodiafiltration mode. Anticoagulation and buffer are provided by the use of a dilute solution of trisodium citrate in the replacement fluid which is infused in a predilution mode. Standard bicarbonate containing dialysate is used.
12000945|NCT00583752|Biological|Adenovirus/PSA Vaccine|1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
12000946|NCT00583739|Behavioral|Yoga|Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.
12000947|NCT00583726|Behavioral|motivational interviewing|telephone counseling
12000948|NCT00583726|Behavioral|written materials only|dietary guidance materials and pedometers
12000949|NCT00583713|Drug|BLI-800|BLI-800 oral solution (two doses)
12000950|NCT00583700|Drug|Pentoxifylline|Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
12000951|NCT00583700|Drug|Vitamin E|Vitamin E (Over-the-counter) 400 I.U. once daily
12000952|NCT00583687|Device|Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)|Attachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient.
12000953|NCT00583687|Other|Passive leg raising|Passive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis.
12000954|NCT00583687|Other|Volume challenge / Change of vasoactive drugs or inotropics|Either a volume challenge (using colloids or crystalloids) or a change in the dosage of of vasoactive drugs or inotropics, or a combination of them, as proposed by the treating physician.
12000955|NCT00583687|Device|Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)|Tissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period.
12000956|NCT00583674|Drug|AMG 386 placebo|AMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000957|NCT00583674|Drug|AMG 386 10mg/kg|AMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000958|NCT00583674|Drug|AMG 386 3mg/kg|AMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000959|NCT00583674|Drug|Cisplatin|Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000960|NCT00583674|Drug|Capecitabine|Capecitabine1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000961|NCT00583674|Drug|Cisplatin|Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000962|NCT00583674|Drug|Capecitabine|Capecitabine 1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000963|NCT00583674|Drug|Cisplatin|Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000964|NCT00583674|Drug|Capecitabine|Capecitabine 1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
12000965|NCT00583661|Device|EXCOR Pediatric|Extracorporeal Ventricular Assist Device
12000966|NCT00583648|Other|Urinanlysis|sending a Urine sample to the laboratory for processing
12000967|NCT00583622|Drug|Bevacizumab|5 mg/kg by vein daily over 90 minutes for 2 Days
12000968|NCT00583622|Drug|Carboplatin|333 mg/m^2 by vein over 2 hours for 3 Days
12000969|NCT00583622|Drug|Docetaxel|300 mg/m^2 by vein over 2 hours for 1 Day
12000970|NCT00583622|Drug|Gemcitabine|1,800 mg/m2 by vein over 3 hours for 4 Days
12000971|NCT00583622|Drug|Melphalan|50 mg/m^2 by vein over 15 minutes for 3 Days
12000972|NCT00583622|Procedure|Stem Cell Transplant|"Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest
~Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen"
12000973|NCT00583609|Drug|PEG3350|PEG3350
12000974|NCT00583596|Device|Device closure with AMPLATZER Duct Occluder|Device closure with AMPLATZER Duct Occluder
12000975|NCT00583596|Other|Objective Performance Criteria|Compare results of device closure to objective performance criteria
12000976|NCT00583583|Device|Device closure with the AMPLATZER Duct Occluder|Device closure with the AMPLATZER Duct Occluder
12000977|NCT00583570|Behavioral|dietary education|dietary education
12000978|NCT00583557|Drug|belimumab|IV 10mg/kg Q28 days
12000979|NCT00583544|Drug|TC-2216|Multiple ascending dose groups will be explored.
12000980|NCT00583531|Drug|AST-120|Oral, 2 grams TID in sachets for 4 weeks
12000981|NCT00583518|Drug|Parathyroid hormone (PTH)|Postmenopausal women with primary osteoporosis
12000982|NCT00583505|Device|Device closure with the AMPLATZER Membranous VSD Occluder|Device closure with the AMPLATZER Membranous VSD Occluder
12000983|NCT00583492|Biological|Ad5-yCD/mutTKSR39rep-ADP|Ad5-yCD/mutTKSR39rep-ADP (1 x 10^12 vp) on day 1 Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy
12000984|NCT00583492|Radiation|IMRT|40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
12000985|NCT00583479|Other|one injection into the celiac ganglion|one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
12000986|NCT00583479|Other|two injections into the celiac ganglion|two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
12000987|NCT00583466|Drug|Autologous blood injection|Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion
12000988|NCT00583466|Drug|Normal saline|Normal saline will be injected under the lesion to create submucosal cushion
12000989|NCT00583466|Drug|HPMC|Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
12000990|NCT00583453|Drug|Celecoxib|"Celecoxib 200 mg capsule
~capsule the night before surgery
~capsules the morning of surgery
~1 capsule the night of surgery
~1 capsule twice daily for 10 days immediately after the surgery"
12000991|NCT00583453|Drug|Placebo|"Placebo capsule
~capsule the night before surgery
~capsules the morning of surgery
~1 capsule the night of surgery
~1 capsule twice daily for 10 days immediately after the surgery"
12000992|NCT00583440|Behavioral|12-step facilitation|12 weekly individual 12-step facilitation sessions
12000993|NCT00583440|Behavioral|Treatment as usual|Usual clinical treatment in a dual diagnosis treatment program
12000994|NCT00583427|Drug|Sulodexide|200 mg per day in an oral gelcap form
12000995|NCT00583414|Device|Endovascular Aneurysm Repair|Endovascular exclusion of aneurysm
12000996|NCT00583401|Device|Device closure with the AMPLATZER PFO Occluder|Device closure with the AMPLATZER PFO Occluder
12000997|NCT00583388|Dietary Supplement|L-arginine|Each subject will be exposed to three treatments, a) 5 g of L-arginine, b) 15 g of L-arginine, and c) placebo, the sequences will be randomly assigned to the 42 volunteers. The washout period between interventions will be from one to two days.L-arginine will be mixed in 60 cc of dextrose-based syrup to blind the taste and color of the L-arginine powder.
12001062|NCT00582777|Behavioral|USUAL - take your BP Meds as you usually do|The patient's antihypertensive regimen at the baseline visit is the comparison (or control) regimen. All once a day medications will be administered in the morning.
12000998|NCT00583388|Device|Ultrasound|Ultrasound from the brachial artery will be done on 3 occasions: at 9 pm after 4hs of fasting, at 6 am and at 11 am. The brachial artery images will be acquired above the antecubital fossa in the longitudinal plane of the artery with an ultrasound machine using a 6-MHz linear transducer. Flow-mediated vasodilatation will be assessed by the reactive hyperemia method (inflation of a blood pressure cuff around the forearm to 200 mmHg for 5 minutes and then released). The diameter of the brachial artery will be assessed 60 to 90 s after deflation of the cuff. After a 10min period a second baseline image of the brachial artery will be obtained. Non-low-mediated vasodilatation will be measured by an administration of a sublingual dose of nitroglycerin (0.4 mg).
12000999|NCT00583375|Device|Augment® Bone Graft|Augment® Bone Graft
12001000|NCT00583375|Procedure|Standard of Care|Autologous Bone Graft
12001001|NCT00583362|Biological|Belimumab|Belimumab 10mg/kg IV over one hour every 28 days
12001002|NCT00583349|Drug|Paclitaxel, nanoparticle albumin-bound|Intravesically administered, dose escalation, 6 weekly instillations
12001003|NCT00583336|Device|ShuntCheck|Thermal dilution test for CSF flow
12001004|NCT00583323|Drug|Lomotil|Orally 10ml of Lomotil
12001005|NCT00583323|Other|Normal saline|10 ml orally
12001006|NCT00583310|Behavioral|Telephone-based lifestyle counseling|Four 30-minute telephone sessions including education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure.
12001007|NCT00583271|Drug|triamcinolone|80mg of triamcinolone injected into the celiac ganglion during the EUS-CB
12001008|NCT00583271|Drug|98% dehydrated alcohol|10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB
12001009|NCT00583258|Drug|Alfuzosin (Xatral)|10 mg PO once a day
12001010|NCT00583258|Drug|Placebo Alfuzosin|10 mg PO once a day
12001011|NCT00583245|Other|Gait Training|Gait training with physical therapist 2/week for 3 months
12001012|NCT00583232|Drug|Stable isotope infusions|Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.
12001013|NCT00583219|Drug|Botulinum-A toxin|A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
12001014|NCT00583219|Drug|Dimethyl sulfoxide (DMSO)|Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.
12001015|NCT00583193|Drug|Duloxetine hydrochloride|Start 30 mg Q.D. for 7 days, then increased to 60 mg Q.D. @ the week 1 visit. Thereafter, dose may be increased or decreased by 30 mg increments based on tolerability and efficacy between a dosage range of 60 to 120 mg.
12001016|NCT00583180|Drug|Capsaicin|instillation of sterile water or 1000 micrograms of capsaicin into the wound at the end of open groin hernia surgery in previous study.no new intervention will be performed in the current study.
12001017|NCT00583154|Drug|BLI-801|Dose 1
12001018|NCT00583154|Drug|BLI-801|Dose 2
12001019|NCT00583154|Drug|BLI-801|Dose 3
12001020|NCT00583154|Drug|BLI-801|Dose 4
12001021|NCT00583128|Drug|AST-120|oral, sachet, 2 grams three times daily for 8 weeks
12001022|NCT00583128|Drug|Celphere® CP-305|oral, placebo, sachet, 2 grams three times daily for 8 weeks
12001023|NCT00583115|Drug|Gleevec|260 mg/M2/day, given once daily by mouth
12001024|NCT00583102|Drug|Cytarabine|Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.
12001025|NCT00583102|Drug|Lovastatin|Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day.
12001026|NCT00583076|Drug|AST-120|AST-120, 2grams,three times daily for 4 weeks. Responders in the second cohort of patients are eligible to receive AST-120 for up to 52 weeks.
12001027|NCT00583063|Drug|sunitinib|25 mg daily (oral dosing)
12001028|NCT00583063|Drug|rapamycin|4 mg daily (oral dosing)
12001029|NCT00583050|Device|Endovascular Aneurysm Repair|Endovascular exclusion of aneurysm
12001030|NCT00583037|Device|Neurally Adjusted Ventilatory Assist (NAVA)|Mechanical ventilation controlled by diaphragm electrical activity
12001031|NCT00583024|Biological|ADENOVIRUS/PSA VACCINE|1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
12001032|NCT00583011|Drug|Local anesthesia - lidocaine|Local anesthesia: 2 cc of 1% Lidocaine
12001033|NCT00583011|Drug|Placebo Group|Placebo Group: 2cc Normal Saline
12001034|NCT00582998|Procedure|Standard Wound Dressing|Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.
12001035|NCT00582998|Device|Vacuum Assisted Closure Device|Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.
12001036|NCT00582985|Drug|TRC105 chimeric anti-CD105 antibody|TRC105 is a human/murine chimeric IgG1 antibody administered i.v. every two weeks (on days 1 and 15) or weekly (on days 1, 8, 15 and 22) of each 28 day cycle; until progression or unacceptable toxicity develops.
12001037|NCT00582972|Drug|Omeprazole|40 mg po qAM one-half hour before breakfast for 30 days
12001038|NCT00582959|Other|Cone Beam Imaging|Prototype, third generation EPID based portal imaging system utilizing the MV approach.
12001039|NCT00582946|Device|Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.
12001063|NCT00582777|Behavioral|HS DOSING|Take your usual BP meds at bed time
12001064|NCT00582777|Drug|ADD On Dosing|Take your usual BP meds but add one more med at bed time.
12001121|NCT00582140|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
12001122|NCT00582140|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
12001040|NCT00582933|Drug|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF|"All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
~The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction."
12001041|NCT00582933|Drug|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF|"All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (Thymoglobulin®) prior to transplant to promote engraftment. No drug prophylaxis against GvHD will be administered post transplant. All research participants will also receive G-CSF posttransplant to foster engraftment.
~The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction."
12001042|NCT00582933|Drug|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF|"All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (Thymoglobulin®) prior to transplant to promote engraftment. No drug prophylaxis against GvHD will be administered post transplant. All research participants will also receive G-CSF posttransplant to foster engraftment.
~The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction."
12001043|NCT00582920|Radiation|Zometa™|Patients who will be receiving zoledronic acid therapy and are scheduled for an extent of disease evaluation with bone scan would undergo a second bone scan within 1 day of zoledronic acid therapy to assess changes in imaging.
12001044|NCT00582907|Drug|Rilonacept|2.2 mg/kg/wk by subcutaneous injection, for 3 months
12001045|NCT00582907|Drug|Placebo|placebo by subcutaneous injection weekly for 3 months
12001046|NCT00582894|Drug|Busulfex, Fludarabine, ALemtuzumab|Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1
12001047|NCT00582868|Device|Licox Brain Oxygen Monitor|use of data from brain oxygen monitor for analysis
12001048|NCT00582868|Other|CSF|analysis of CSF for cleaved tau protein
12001049|NCT00582868|Other|Whole blood|Analysis of whole blood for cleaved-tau protein
12001050|NCT00582855|Drug|AQW051|
12001051|NCT00582855|Drug|Placebo|
12001052|NCT00582842|Behavioral|Interview|The phone interview will consist of the following items from the follow up questionnaire; 14, 16, 20, 32, 33, 46, 47, 60, and 65. An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL.
12001053|NCT00582842|Behavioral|survey instruments using Web-Based Data Collection System (WBDC) survey content|The content of the WBDC questionnaire will be similar to the paper form, no alteration in the wording, the order, or the formate of the items will be done. In addition, at the time of each outpatient clinic visit to MSKCC, these subjects will be able to login to WBDC using a computer located in the patient waiting-area, and enter their responses to the different items of the questionnaire if their clinic visit corresponds to any of the study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment). An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL.
12001054|NCT00582829|Other|Generic Print Intervention|"Generic Print Intervention: The generic print intervention will consist of the pamphlet, Colorectal Cancer Screening Saves Lives published by the Center for Disease Control that will be mailed to the participant."
12001055|NCT00582829|Other|Tailored Print Intervention|Tailored Print Intervention: The tailored print intervention will consist of a cover letter detailing the participant's stage of readiness along with a color pamphlet with information personally tailored for the individual participant.
12001056|NCT00582829|Other|Tailored print plus tailored phone intervention|Tailored print plus tailored phone intervention: The tailored print plus tailored telephone intervention will consist of a phone counseling session and the tailored print information described above. The tailored print material will serve as a guide during the telephone counseling contact and a reinforcement of the information.
12001057|NCT00582816|Device|Clinimacs Cell Separation System|Depletion of T-cells
12001058|NCT00582816|Drug|conditioning chemotherapy|Methylprednisolone, Equine ATG, Cyclosporine, Fludarabine, Melphalan, Thiotepa and Rituximab.
12001059|NCT00582816|Other|DLI|NK Cell selected DLI
12001060|NCT00582790|Drug|IL2|Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
12001061|NCT00582790|Drug|Zoledronic acid|Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-T cell augmentation is seen, the dose of zoledronic acid will be increased in the subsequent cycle up to a maximum dose of 3mg.
12001201|NCT00581373|Other|water 16 fl oz|water 16 fl oz in AM and repeat in late afternoon
12001065|NCT00582764|Other|perform dynamic contrast enhanced (DCE) MRI|With an IV catheter in place, the patient will lie prone on the MRI scanner table with the breasts positioned in the commercial breast coil and then be moved feet first to the center of the MRI scanner. The only difference introduced by the addition of DCE MRI is that before the patient is moved into the scanner for the first time, the IV catheter will be hooked up with a programmable power injector (Medrad, Indianola, PA) which is loaded with Gd contrast and saline. The contrast injection and saline flush will be delivered by the injector while the patient is inside the scanner and the DCE MRI data collection is in process. The Gd contrast dose used for DCE MRI is the same as for clinical MRI: 0.1 mmol/kg. The injection speed of 2 mL/sec is safe and similar to that of manual injection.
12001066|NCT00582738|Drug|CsA-TAC (standard Treatment)|Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.
12001067|NCT00582738|Drug|Everolimus|Hepatitis C recurrence after orthotopic liver transplantation (OLT)
12001068|NCT00582725|Drug|R-CHOP+GM-CSF|addition of GM-CSF
12001069|NCT00582712|Drug|Lithium carbonate|Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.2; Continue until progressive disease/unacceptable toxicity; Evaluate every 4 weeks.
12001070|NCT00582699|Behavioral|assessment interview and blood draw|All subjects will be administered a battery of clinician rated and self report instruments including measures of depression, fatigue, and cognitive functioning. In addition, measures of pain, sleep, and anxiety will also be utilized to assess these important potential confounding variables. The SCIDIV will be used to ascertain the presence or absence of a current DSMIV diagnosis of Major Depressive Episode for all subjects. The interview should take approximately fortyfive minutes to complete. Patients will have their blood drawn once, in order to determine plasma levels of the cytokines IL1, IL6, TNFalpha, IL10, IL15 and IFNgamma.
12001071|NCT00582686|Procedure|ORIF of Calcaneus with bone grafting|The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting
12001072|NCT00582686|Procedure|ORIF of Calcaneus without bone grafting|The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)
12001073|NCT00582673|Drug|AFQ056|
12001074|NCT00582673|Drug|Placebo|
12001075|NCT00582660|Drug|Celecoxib|400 mg twice a day for 7 days prior to surgery
12001076|NCT00582660|Drug|Placebo|one tablet of placebo will be given for 7 days prior to surgery
12001077|NCT00582634|Drug|docetaxel and cisplatin|Docetaxel (75mg/m2) followed by cisplatin (75mg/m2) on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for4 cycles.
12001078|NCT00582608|Drug|131I-8H9|This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m^2 dose [intended specific activity of ~20 mCi/mg protein]
12001079|NCT00582608|Drug|8H9|administration of 50mg/1.73m^2 of unlabeled 8H9.
12001080|NCT00582582|Drug|Docetaxel plus doxercalciferol|Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day
12001081|NCT00582582|Drug|Docetaxel plus placebo|Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day
12001082|NCT00582556|Drug|Zometa|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
12001083|NCT00582556|Drug|zometa|GnRH analogue 3-mo depot - q3 months for 1 yr andZometa 4 mg IV over 15 min x 1, given at mo 6
12001084|NCT00582556|Drug|Zometa|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
12001085|NCT00582543|Other|eMRI/MRSI|Patients will undergo eMRI/MRSI examination. All subjects will be asked to administer a Fleet enema on the day of the study in order to reduce the potential for fecal residue to interfere with imaging acquisition and quality. Upon arrival at the MRI suite, patients will be asked to complete a standard MRI screening form. Patients will be scanned in the supine position. The entire eMRI/MRSI study will be performed within 55-60 minutes.
12001086|NCT00582530|Other|Whole Blood Draw|The plan is to obtain the research blood sample at the time of routine preoperative and postoperative blood testing, typically performed 1-2 weeks prior to surgery and then again 6 weeks to 12 months after surgery
12001087|NCT00582517|Device|Compass Universal Hinge External Fixator|Application of the Compass Knee Hinge adds approximately 30 minutes to the surgical time. After the apparatus has been in place for the appropriate amount of time (6-8 weeks), it is removed either in the clinical setting, or in the one-day surgery area of UAB Highlands.
12001088|NCT00582517|Procedure|Non-invasive External Knee Brace|For Group A patients, an external knee brace (several brands available and no one brace specified for this study) will be placed on the leg following surgical repair of the knee dislocation.
12001089|NCT00582504|Biological|VEE TC-83|Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm
12001090|NCT00582491|Drug|Modafinil|Modafinil 400mg orally every day for 16 days
12001091|NCT00582491|Drug|Placebo|Placebo orally everyday for 16 days
12001092|NCT00582478|Behavioral|questionnaires|Participants will be followed regularly at 3, 6, 12, and 18-month intervals
12001093|NCT00582452|Other|Telephone survey|Telephone survey
12001094|NCT00582439|Device|Reamer-Irrigator-Aspirator (RIA)|Patients must already be scheduled for bone grafting of a fracture or nonunion with harvest of autologous graft material from their femur using the RIA system. The reaming procedure will be conducted using the trochanteric entry portal through the tip of the greater trochanter.
12001095|NCT00582426|Drug|Octreotide Long Acting Release|Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first.
12001096|NCT00582426|Other|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
12001097|NCT00582413|Behavioral|questionnaires|Patient will fill out questionnaires, initial clinic visit, first post-surgery clinic evaluation and 3, 6, 12, 18 and 24 months following completion of all therapy.
12001119|NCT00582166|Drug|Ibritumomab Tiuxetan (Zevalin) + Rituximab|Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
12001098|NCT00582400|Drug|arsenic trioxide|"Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.
~The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution."
12001099|NCT00582387|Genetic|specimen samples|blood, urine and tissue
12001100|NCT00582387|Behavioral|questionnaires|
12001101|NCT00582361|Procedure|Standard Wound Dressing|Group A patients will have a standard dressing applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.
12001102|NCT00582361|Device|VAC|Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.
12001103|NCT00582309|Procedure|Glucommander-Guided Intravenous Insulin Infusion|"Glucommander-Guided Intravenous Insulin Infusion.
~Prepare IV Insulin Drip: 250 units of glulisine (Apidra®) insulin with 250 ml NS (1.0 unit/ml). Piggyback insulin drip into IV fluids.
~During the infusion, enter glucose levels into the Glucommander and follow recommendations regarding infusion rate and time to measure next blood glucose levels."
12001104|NCT00582309|Procedure|Standard Intravenous Insulin Infusion|"Standard Intravenous Insulin Infusion Standard Intravenous Insulin Infusion in the ICU setting Prepare IV Insulin Drip: 250 units of glulisine (Apidra®) insulin with 250 ml NS (1.0 unit/ml). Piggyback insulin drip into IV fluids.
~Algorithm 1: Start here for most patients. Algorithm 2: For patients not controlled with Algorithm 1, or receiving glucocorticoids, or patient with diabetes receiving >80 units/day of insulin as an outpatient.
~Algorithm 3: For patients not controlled on Algorithm 2.No Patients Start Here."
12001105|NCT00582309|Procedure|Simple Calculated Intravenous Insulin Infusion|If the patient was on insulin prior to this admission, 1/2 of the total insulin dose divided by 24 will be the initial insulin infusion rate. The amount of insulin given will be dependant upon blood sugar levels ( BG levels 80-120= 0.5 units/hr, 121-160=1.0 units/hr, 161-200= 2.0 units/hr, 201-240= 3.0 units/hr, 241-280= 4.0 units/hr, 281-320= 5.0 units/hr, 321-360=6.0 units, 361-400= 7.0 units, greater than 400= 8.0 units.
12001106|NCT00582296|Behavioral|questionnaires, telephone interview, optional blood drawn|Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview Participants may also donate an additional blood, serum, saliva, urine, or stool sample for research, (in addition to the blood drawn for clinical testing) or for the sole purpose of research testing (in absence of clinical testing or prior external testing).
12001107|NCT00582296|Behavioral|questionnaires, telephone interview and optional blood drawn|Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview Participants may also donate an additional blood, serum, saliva, urine, or stool sample for research, (in addition to the blood drawn for clinical testing) or for the sole purpose of research testing (in absence of clinical testing or prior external testing).
12001108|NCT00582283|Drug|I124-NM404|I-124-NM404
12001109|NCT00582257|Behavioral|questionnaires|Participation in the registry will consist of adequately completing the family history questionnaire (one per family) the gastric cancer risk factor questionnaire and providing a blood sample for future correlative studies. Registry participants (both Patient/Relative and Control cohorts) will be required to submit tissue (both normal and/or tumor) to create a Tissue and DNA repository. Select participants will be invited to undergo Genetic Counseling, eg. those participants who meet clinical criteria for HDGC.
12001110|NCT00582244|Behavioral|CBT and relaxation|Group A: CBT and relaxation.
12001111|NCT00582244|Behavioral|Physical activity|Group B: Physical exercise program.
12001112|NCT00582244|Behavioral|CBT and physical activity|Group AB: Combined CBT and exercise program. Women assigned to Group AB will undergo the CBT and exercise elements of the program concurrently. To as great an extent as possible, the on-site CBT and in-clinic exercise training sessions will be scheduled on the same day.
12001113|NCT00582244|Other|Control group|Waiting list control group
12001114|NCT00582231|Other|Questionnaires.|Questionnaires.
12001115|NCT00582205|Drug|Paclitaxel, Cisplatin IP|Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
12001116|NCT00582192|Other|Consult visit|Your appointment with your doctor will be audio taped. The research team will listen to the tape(s) and type them up. The team will then look for patterns in the discussions between patients and doctors. They will use this information to see if the discussions can be improved.
12001117|NCT00582179|Procedure|Standard Pressure Dressing|If hematoma still draining at 5 days post surgery, patients who randomize to Group A will have a standard pressure dressing applied and checked every 24-48 hours for continued draining. If still draining at 10 days post surgery, patient is at end point of study and must return to OR for Irrigation and Debridement of the wound. If infection occurs, patient is at end point of study and must return to OR for I&D.
12001118|NCT00582179|Device|VAC|If hematoma still draining at 5 days post surgery, patients who randomize to Group B will have a VAC negative pressure device applied and checked every 24-48 hours for continued draining. If still draining at 10 days post surgery, patient is at end point of study and must return to OR for Irrigation and Debridement of the wound. If infection occurs, patient is at end point of study and must return to OR for I&D.
12001120|NCT00582140|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
12001123|NCT00582114|Drug|Lisinopril|Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
12001124|NCT00582114|Drug|Atenolol|Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
12001125|NCT00582101|Behavioral|Family-Based HIV Prevention for Latinos|7-hour one-day workshop with adolescents and parents in separate and joint sessions
12001126|NCT00582101|Behavioral|General Health Promotion|7 hour one-day workshop on general health promotion topics
12001127|NCT00582088|Biological|VEE C-84|Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer <1:20.
12001128|NCT00582075|Drug|temozolomide|TMZ 200mg/m2 days 1-5 repeat q28 days. Patients who have received prior chemotherapy will receive 150 mg/m2 days 1-5
12001129|NCT00582062|Other|washings for experimental marker testing|During the laparoscopy, a small amount of a mild salt solution will be introduced to gently wash the inside of the abdomen. The fluid will be removed and sent to the laboratory for two analyses: 1) washings for cytology (routine), and 2) washings for experimental marker testing (experimental).
12001130|NCT00582036|Drug|Regular Insulin|Use of sliding scale insulin as per Appendix 1
12001131|NCT00582036|Device|Deployment of the MiniMed Paradigm monitoring device|Automated insulin delivery system
12001132|NCT00582010|Drug|inhaled nitric oxide|inhaled 80ppm for duration of surgery.
12001133|NCT00582010|Drug|nitrogen gas|inhaled
12001134|NCT00581997|Drug|QAX576|
12001135|NCT00581997|Drug|Placebo|
12001136|NCT00581971|Drug|celecoxib|400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
12001137|NCT00581971|Drug|Carboplatin|IV, AUC 2.0, weekly for weeks 1 through 7
12001138|NCT00581971|Drug|Paclitaxel|IV 30 mg/m2, weekly for weeks 1 through 7
12001139|NCT00581971|Radiation|Radiation Therapy|70.2Gy, at 1.8Gy qd, Monday through Friday
12001140|NCT00581958|Other|Blood Samples|blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.
12001141|NCT00581945|Drug|Canakinumab|The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.
12001142|NCT00581945|Drug|Placebo|Matching placebo to ACZ885 administered via intravenous infusion.
12001143|NCT00581919|Drug|Bort, Dex, and Dox with ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
12001144|NCT00581906|Radiation|DCE-MRI, DW-MRI and MRS|Pts undergo DCE-MRI, DW-MRI or 1^H-MRS studies on either the 1.5T scanner or the 3T MRI scanners. Patients will be grouped based on their treatment: group one will include pts who undergo surgery (we will no longer accrue pts in this group) & group two will include pts who undergo chemoradiation therapy.Pts who undergo surgery will have pretreatment DCE-MRI, DW-MRI &/or 1H-MRS studies on the GE 1.5T or 3T MRI scanner. Pts who participate in chemo-radiation therapy protocols will have pretreatment DCE-MRI, DW-MRI &/or 1H-MRS studies on the 3T Philips MRI scanner in the radiation oncology suite & will undergo additional recommended weekly DW-MRI including IVIM studies at the same MRI scanner during the course of treatment. Pts will undergo two recommended DCE-MRI studies (unless contraindicated) when possible. 1st intra-treatment DCE-MRI is recommended between the 1st & 2nd weeks of treatment & the 2nd intra-treatment DCE-MRI is recommended between the 3rd & 4th weeks of treatment.
12001145|NCT00581893|Drug|Phenytoin|Phenytoin will be dosed to a target dose of 5 mg/kg qhs for one month
12001146|NCT00581880|Behavioral|questionnaires|A battery of questionnaires concerning your thoughts, opinions, and attitudes about your illness and outlook on life. In addition, we will ask to provide some background information about you and your illness. The questions will take approximately 30 to 45 minutes to complete. You fill out the questionnaire once only.
12001147|NCT00581867|Drug|Insulin Aspart|40IU insulin aspart applied intranasally
12001148|NCT00581867|Drug|Placebo|Placebo
12001149|NCT00581854|Drug|modified Hyper-CVAD|rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
12001150|NCT00581841|Other|Gait analysis, knee x-ray, and knee MRI|Gait analysis, knee x-rays, and knee MRIs will be done twice for each participant, 1 week apart.
12001151|NCT00581828|Drug|Vitamin D|50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year)
12001152|NCT00581815|Device|Proton-decoupled 31P MRS at 1.5T|The study will use a dual 1H-31P surface coil pair obtained from IGG Medical Advances, Milwaukee, WI. The coil pair consists of a fixed, 12 cm square 31P resonator co-mounted with a flexible two-loop proton coil. The P.I. and colleagues have used this device for approximately 10 years with no apparent ill effects
12001153|NCT00581815|Device|1H Spectroscopy at 1.5T and 3T|The study will use surface coils manufactured by commercial vendors. The pulse sequence programs to be used will be monitored automatically by the scanner to insure that SAR limits are not exceeded.
12001154|NCT00581789|Drug|erlotinib, sunitinib|erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)
12001155|NCT00581776|Drug|Bortezomib|Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
12001156|NCT00581776|Drug|Rituximab|Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
12001157|NCT00581776|Drug|Cyclophosphamide|Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
12001158|NCT00581776|Drug|Doxorubicin|Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.
12001159|NCT00581776|Drug|Vincristine|1 mg administered by IV on day 3 of each cycle.
12001160|NCT00581776|Drug|Dexamethasone|40 mg orally on days 1-4 of each cycle.
12001161|NCT00581750|Other|Tissue specimen|Human tissues taken after the clinically indicated removal of these tissues from patients as part of their routine care.
12001162|NCT00581724|Behavioral|Telephone interview or self report survey.|We estimate that the completion time for the telephone interview or self-report survey will be 45-60 minutes.
12001163|NCT00581711|Other|3-Part Intervention|A combination of training, an otitis media episode grouper, and clinical decision support.
12001164|NCT00581711|Other|4-Part Intervention|A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.
12001165|NCT00581711|Other|1-part intervention|Provision of feedback on otitis media quality indicators
12001166|NCT00581685|Drug|Pregabalin, Celecoxib|Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively.
12001167|NCT00581672|Behavioral|questionnaires of quality of life|Subjects will be asked to complete the MAX-PC along with additional psychosocial questionnaires which include anxiety, depression coping methods, resilience spirituality, religiosity, and quality of life measures and will take approximately one 30 to 45 minutes to complete by patient.
12001168|NCT00581646|Behavioral|survey instrument|Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone. We expect the study survey to take approximately 35-45 minutes to complete. The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
12001169|NCT00581633|Other|normal saline (0.9%)|liter normal saline over 30 minutes x 1 dose
12001170|NCT00581620|Biological|pneumococcus conjugate vaccine|Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
12001171|NCT00581607|Drug|Bosentan|62.5 mg bid for 4 weeks, then 125 mg bid
12001172|NCT00581607|Drug|Placebo|Placebo twice a day
12001173|NCT00581607|Drug|Bosentan|drug given for 16 weeks
12001174|NCT00581607|Drug|Placebo|placebo
12001175|NCT00581594|Procedure|Graft-augmented colporrhaphy|Patients will undergo randomized surgical procedure. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years for a pelvic exam for evaluation of posterior wall support and the questionnaires.
12001176|NCT00581594|Procedure|Traditional posterior colporrhaphy|Patients will undergo randomized surgical procedure. Patients will be seen at 2 weeks for routine post-op care and evaluation of any post-op complications. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months, for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years to have a pelvic exam for evaluation of posterior wall support and the questionnaires.
12001177|NCT00581568|Other|Cutaneous Effects of Cryogen Spray Cooling|Cutaneous Effects of Cryogen Spray Cooling
12001178|NCT00581555|Drug|Etanercept|Etanercept 50 mg QW initiated during taper of ciclosporin
12001179|NCT00581555|Other|Placebo|Randomized to placebo during taper of ciclosporin
12001180|NCT00581542|Drug|moxifloxacin|1-2 drops three times a day for 8-10 days.
12001181|NCT00581542|Drug|polytrim|1-2 drops four times a day for 8-10 days.
12001182|NCT00581529|Radiation|IMRT|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
12001183|NCT00581503|Device|diagnostic|oct imaging
12001184|NCT00581477|Drug|droxidopa|up to 300mg four times daily
12001185|NCT00581477|Drug|placebo|same frequency as experimental medication
12001186|NCT00581477|Drug|alpha-methyldopa|up to 250mg two times daily
12001187|NCT00581477|Drug|carbidopa|up to 25mg four times daily
12001188|NCT00581477|Drug|metyrosine|up to 1000mg three times daily
12001189|NCT00581477|Drug|levodopa|up to 250mg three times daily
12001190|NCT00581477|Drug|atomoxetine|up to 40mg twice daily
12001191|NCT00581477|Drug|metoclopramide|up to 10mg four times daily
12001192|NCT00581464|Behavioral|Standard Behavioral Therapy|Standard therapy to help participants with smoking cessation.
12001193|NCT00581464|Behavioral|Mindfulness Based Addiction Therapy|A novel mind body therapy that extends basic behavioral therapy principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.
12001194|NCT00581451|Drug|bifeprunox|oral tablet once daily
12001195|NCT00581425|Biological|Imiquimod and Interferon alpha|Imiquimod first two weeks and last two weeks. Interferon middle five weeks.
12001196|NCT00581399|Device|NO-NUMO™ High Vacuum Body Cavity Drainage System|(1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump
12001197|NCT00581399|Device|PVC Chest Tube|Standard PVC Chest Tube Sizes 14-36 French
12001198|NCT00581386|Device|LTS-D|supra-glottic airway device
12001199|NCT00581386|Device|ProSeal Laryngeal Mask Airway|pre-existing double-lumen supra-glottic device
12001200|NCT00581386|Device|Esophageal Tracheal Combitube (ETC)|disposable double-lumen tube
12001285|NCT00580658|Device|Medtronic Activa Gpi|Activa Therapy, Gpi
12001202|NCT00581360|Drug|doxorubicin and bortezomib|Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days 1,8,15, every 28 days, will be administered alone. Treatment will continue unless disease progression or intolerable toxicity emerges.
12001203|NCT00581347|Other|outreach services|Tracking/reminder/recall/home visit strategy.
12001204|NCT00581334|Procedure|Robotic-assisted laparoscopic sacrocolpopexy|4 abdominal incisions will be made: 1 infraumbilical port and 3 lateral ports. The peritoneum overlaying the sacrum is entered and the anterior longitudinal ligament is exposed. 3 permanent sutures are placed through the ligament at the S2-S3. Then a vaginal obturator is placed transvaginally and the apex of vagina is elevated into the operative field. The peritoneum overlying the anterior and posterior vaginal epithelium is reflected and the bladder is dissected off the underlying vagina to expose 4cm of apical vagina. 2 segments of polypropylene mesh are prepared and one segment is anchored along the anterior vagina with a series of interrupted permanent suture and the second segment is anchored along the posterior vagina. These 2 segments are brought together to the previously placed sutures within the anterior longitudinal ligament of the sacrum. The peritoneum is then closed over the graft complex and the pelvis irrigated. The 4 robotic ports are removed and the abdomen closed.
12001205|NCT00581321|Dietary Supplement|water|water 500 ml x 1
12001206|NCT00581308|Device|GORE® HELEX® Septal Occluder|Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)
12001207|NCT00581295|Device|Diffuse optical spectroscopy|Diffuse optical spectroscopy measurment
12001208|NCT00581282|Radiation|PET scan|positron emission tomography PET scan
12001209|NCT00581282|Other|fMRI|functional magnetic resonance imaging fMRI
12001210|NCT00581269|Behavioral|low-impact aerobic exercise|subjects will undergo supervised physical activity for a maximum of 30-60 minutes, every other day, 3 days per week for 3 months; to offer variety in the exercise prescription, subjects will alternately use a treadmill, an elliptical trainer, a Nu-Step cross-trainer and a recumbent stationary bicycle
12001211|NCT00581269|Dietary Supplement|low-calorie (low-fat) diet|subjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months
12001212|NCT00581256|Radiation|IMRT|All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.
12001213|NCT00581256|Radiation|3D|All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease
12001214|NCT00581243|Drug|SLV-313 SR|sustained relase tablets taken once daily for 14 days
12001215|NCT00581230|Device|Laryngoscopy with RAMP|inflatable positioning ramp
12001216|NCT00581230|Device|Laryngoscopy without RAMP|Laryngoscopy without RAMP
12001217|NCT00581217|Other|Aquacel Ag|Aquacel Ag will be applied to one donor site.
12001218|NCT00581217|Other|Glucan II|Glucan II to be applied to a donor site on same patient for comparison
12001219|NCT00581204|Device|Near-Infrared Diffuse Optical Spectroscopy|Early predictor of hemorrhagic shock
12001220|NCT00581191|Drug|SLV-351|SLV-351 capsules taken once
12001221|NCT00581165|Drug|Etanercept|recommended dose of enbrel is 25mg administered twice weekly.
12001222|NCT00581139|Behavioral|Preoperative Preparation Program (Child Life Specialist)|This group will receive the standard preoperative visit to the hospital with Child Life intervention
12001223|NCT00581139|Drug|Midazolam|0.5 mg/kg oral midazolam
12001224|NCT00581139|Behavioral|Parental Presence during Induction of Anesthesia|One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.
12001225|NCT00581139|Other|PPIA preparation program PLUS Midazolam premedication|Subjects in this group will receive both interventions 2 and 3.
12001226|NCT00581126|Drug|Recombinant Factor IX Coagulation|Benefix IV each 12 hours for 2 a 5 days
12001227|NCT00581113|Radiation|Radiotherapy|Treatments are delivered through parallel opposed or 5 degree RAO/LAO fields that cover the entire cranial contents. There should be beam fall-f of at least 1 cm. The eyes must be excluded from the beam either by field arrangement or shielding.
12001228|NCT00581100|Drug|etanercept|"Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.
~Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period."
12001229|NCT00581087|Drug|DHEA treatment|DHEA : 200 mg/day hard gelatine capsule
12001230|NCT00581087|Drug|Placebo|Treatment : 200 mg/day hard gelatine capsule
12001231|NCT00581074|Behavioral|diet (grapefruit or grapefruit juice)|weight loss diet
12001232|NCT00581061|Drug|Vesicare|Vesicare will be taken daily for one or three months, depending on symptoms of subject.
12001233|NCT00581048|Drug|Natural source d-α-tocopheryl acetate|1500 units daily for 16 weeks
12001234|NCT00581035|Biological|Prevenar and Meningitec|1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months
12001235|NCT00581035|Biological|Prevenar|1 dose at 2,3.5,6 and 12 months
12001236|NCT00581035|Biological|Meningitec|1 dose at 2,6 and 12 months
12001237|NCT00581022|Procedure|Polysomnography|Overnight Sleep Study
12001238|NCT00581009|Other|chronobiological augmentation|Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days
12001283|NCT00580671|Behavioral|CM|Abstinence-based incentives delivered contingent on drug-negative urine test results.
12001284|NCT00580671|Behavioral|BPT|Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills.
12001239|NCT00581009|Drug|sertraline, lithium|"Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.
~Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks."
12001240|NCT00581009|Radiation|one night of sleep deprivation and two FDG PET scans|MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.
12001241|NCT00580996|Other|water high dose|water 16 oz PO x 1
12001242|NCT00580996|Other|water tiny dose|water 1 oz PO x 1
12001243|NCT00580983|Radiation|IMRT|
12001244|NCT00580983|Drug|Paclitaxel|
12001245|NCT00580983|Drug|Carboplatin|
12001246|NCT00580983|Drug|Cisplatin|
12001247|NCT00580983|Drug|5-Fluorouracil|
12001248|NCT00580970|Drug|lovastatin|The HMG-coA reductase inhibitor used in this study will be lovastatin. Dosage: 20 mg/d PO with evening meal. Patients on a higher dose of lovastatin at the time of study entry may continue at that dose level; for patients switching to lovastatin, the dose will be at the discretion of the prescribing physician, but must be at least 20 mg/day.Schedule: begin on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months. Patients or their third party payers will be expected to cover the cost of the drug.
12001249|NCT00580957|Drug|Blocked|Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance
12001250|NCT00580957|Drug|Intact|Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance
12001251|NCT00580944|Procedure|laser treatment of port wine stain birthmarks|Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
12001252|NCT00580931|Drug|Nicotinamide|1500 mg twice a day for 6 months
12001253|NCT00580931|Drug|Enduramide placebo|1 tab twice a day
12001254|NCT00580918|Other|functional magnetic resonance imaging fMRI|functional magnetic resonance imaging fMRI
12001255|NCT00580905|Drug|Adenosine|IV infusion of adenosine at a dose of 80 mcg/kg/min for 30 minutes.
12001256|NCT00580905|Drug|Sodium Nitroprusside|To compare the effects of adenosine on increasing cytokines, sodium nitroprusside will be infused at 5 mcg/kg/min (a dose expected to produce similar systemic effects to adenosine)
12001257|NCT00580905|Drug|Adenosine|"The local effects of adenosine or sodium nitroprusside will be studied in response to microinjection (intradermally) of both drugs. Two microdialysis catheters (CMA 100) will be inserted intradermally in the volar aspect of the forearm after numbing the area with local cold (ice applied in the study area). After 30 minutes,one catheter will be infused with sodium nitroprusside (2microliters/min of a 28 mM solution) and the other with adenosine (2mcl/min of a 100 microM solution) will then be started and continued for 60 minutes. Skin blood flow will be monitored throughout the study with the used of a skin laser Doppler fluxometer mounted adjacent to the area of the microdialysis probe.
~A 2 mm skin biopsy punch will be performed 60 minutes after the end of the infusion."
12001258|NCT00580892|Device|Optical Coherence Tomography imaging|Optical Coherence Tomography imaging
12001259|NCT00580866|Device|JAS Brace|For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
12001260|NCT00580853|Drug|varenicline|2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).
12001261|NCT00580853|Drug|bupropion|300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).
12001262|NCT00580853|Drug|Placebo|Placebo
12001263|NCT00580840|Drug|Certolizumab pegol|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
12001264|NCT00580840|Drug|Certolizumab pegol|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
12001265|NCT00580840|Other|Placebo|placebo (saline) administered as two injections every 2 weeks
12001266|NCT00580827|Drug|Placebo|Matched placebo.
12001267|NCT00580827|Drug|Disulfiram|disulfiram at 62.5 mg/day for 12 weeks.
12001268|NCT00580827|Drug|Disulfiram|Disulfiram at 125 mg/day for 12 weeks.
12001269|NCT00580827|Drug|Disulfiram|disulfiram at 250 mg/day for 12 weeks.
12001270|NCT00580814|Drug|Methylphenidate|Methylphenidate
12001271|NCT00580801|Drug|Telaprevir|Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.
12001272|NCT00580801|Drug|Pegylated-interferon-alfa-2a|Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
12001273|NCT00580801|Drug|Placebo|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.
12001274|NCT00580801|Drug|Ribavirin|Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
12001275|NCT00580788|Drug|PTHrP (1-36)|IND # 49,175
12001276|NCT00580762|Procedure|Roux-en-y gastric bypass (RYGB)|
12001277|NCT00580749|Procedure|Naso jejunal feeding tube insertion|Placement of feeding tube through nare and into jejunum for administration of enteral feeding.
12001278|NCT00580749|Procedure|NG feeding tube insertion|Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.
12001279|NCT00580736|Device|Optical Clearing|Optical Clearing
12001280|NCT00580723|Other|PRK 124|Topical PRK 124 (0.125%) moisturizing lotion applied twice daily to the face for 48 weeks
12001281|NCT00580684|Biological|pneumococcus conjugate vaccine 7 valent to reduce carriage|plain polisacaride vaccine 23 valent to reduce carriage
12001282|NCT00580671|Behavioral|MET/CBT|Weekly Individual Counseling Sessions
12001606|NCT00578305|Drug|Methotrexate|
12001286|NCT00580645|Drug|varenicline|2mg/day or 1mg/day with 1-week medication lead-in period.
12001287|NCT00580645|Drug|placebo|placebo
12001288|NCT00580619|Other|Autonomic Function Testing|The autonomic function tests include asking the subject to breathe deeply for two minutes and breathing as fast and as hard as they can for 30 seconds, maintaining a handgrip for 3 minutes, breathing against pressure for 15 seconds, placing one hand in ice water for 1 minute and an orthostatic test. All these tests are meant to stimulate the autonomic nervous system to produce changes in blood pressure and heart rate of short duration that reflect how well the involuntary nervous system is working. In addition, a 24-hour blood pressure monitoring and exercise test may be also performed in some subjects.
12001289|NCT00580619|Other|Saline infusions|The effects of continuous IV infusion or pulse IV administration of saline in increasing total blood volume and fatigue score will be evaluated
12001290|NCT00580619|Drug|L-NMMA trimethaphan|Trimethaphan IV infusion for approximately 60 minutes at a dose of 4-6 mg/min L-NMMA IV infusion for approximately 45 minutes at 125, 250, and 500 mg/kg/min for 15 minutes each
12001291|NCT00580619|Drug|methyldopa|Aldomet oral twice a day for 12 weeks
12001292|NCT00580606|Drug|Glycerinated peanut allergenic extract|Glycerinated peanut extract delivered sublingually.
12001293|NCT00580606|Drug|Placebo for peanut extract (glycerin)|Placebo (glycerin) delivered sublingually.
12001294|NCT00580593|Device|BiPAP® S/T System|The BiPAP® S/T System is a NIPPV device that provides intermittent ventilatory assistance to people with difficulty breathing secondary to respiratory muscle weakness.
12001295|NCT00580593|Other|sham-NIPPV|a sham-device
12001296|NCT00580580|Drug|Optison|0.1-0.4 mL through intravenous injection at the beginning of the study.
12001297|NCT00580580|Drug|Definity|intravenous injection at 0.05-0.20 mL
12001298|NCT00580580|Drug|PESDA|intravenous injections dosage 0.05-0.20 mL
12001299|NCT00580541|Behavioral|variety|variety and nonvariety
12001300|NCT00580528|Behavioral|Tailored Internet Newsletters|Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure
12001301|NCT00580528|Behavioral|Tailored print newsletters delivered via mail|Tailored Newsletters with content to improve eating and activity to reduce blood pressure
12001302|NCT00580515|Behavioral|Family Focused Group Therapy|6 Sessions of Family Focused Group Therapy (FFGT). The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases. The first two sessions are assessment sessions and occur one week apart. There will be two or six focused intervention sessions depending on the predetermined length of therapy. The first focused intervention session is approximately two weeks after the last assessment session. Subsequent focused intervention sessions are expected to follow once every month. Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart. The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months.
12001303|NCT00580515|Behavioral|Family Focused Group Therapy|10 Sessions of Family Focused Group Therapy (FFGT). The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases. The first two sessions are assessment sessions and occur one week apart. There will be two or six focused intervention sessions depending on the predetermined length of therapy. The first focused intervention session is approximately two weeks after the last assessment session. Subsequent focused intervention sessions are expected to follow once every month. Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart. The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months
12001304|NCT00580515|Behavioral|Standard of Care|Standard of Care Families assigned to the Usual Care Condition will receive standard psychosocial care which is based on the following patterns: Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request.
12001305|NCT00580502|Device|LAP-BAND® Adjustable Gastric Band (LAGB®)|Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2
12001306|NCT00580489|Drug|either fentanyl or morphine|either morphine 4mg IV or fentanyl 50mcg IV
12001307|NCT00580450|Drug|Thymosin alpha 1|1.6 mg sc once a day for 16 weeks
12001308|NCT00580437|Procedure|Dobutamine Stress Echocardiogram|stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition
12001309|NCT00580424|Drug|Norethindrone|Norethindrone 0.35 mg orally daily
12001310|NCT00580398|Behavioral|Smoking cessation counseling|Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.
12001311|NCT00580398|Drug|varenicline|varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
12001312|NCT00580385|Other|Tissue Procurement|MTX polyglutamylation, MTX transport, XTT cytotoxicity assays, Quantitative RT-PCR, Southern blotting, Mutation detection, and Western blotting
12001313|NCT00580372|Drug|VAD|3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
12001314|NCT00580372|Drug|High-Dose cyclophosphamide|"Approximately 5-6 weeks after VAD 2 or 3:
~Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1"
12001315|NCT00580372|Procedure|Hemopoietic stem cell procurement|Collection target = 10 x 10^6 cells/kg
12001316|NCT00580372|Drug|EDAP|Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5
12001317|NCT00580372|Procedure|Autologous Hemopoietic Stem Cell Transplant 1|4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2
12001318|NCT00580372|Procedure|Autologous Hemopoietic Stem Cell Transplant 2|4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2
12001319|NCT00580372|Drug|Maintenance|3 months after Transplant 2: Intron A 3 X 10^6 units /m2 M-W-F subcutaneously until relapse
12001320|NCT00580359|Drug|S-1, capecitabine|S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression
12001321|NCT00580346|Device|Placement of laryngeal implant|Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
12001322|NCT00580333|Drug|cisplatin|Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
12001323|NCT00580333|Drug|bevacizumab|Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
12001324|NCT00580333|Drug|doxorubicin|Postoperative: Given intravenously for four 2-week cycles
12001325|NCT00580333|Drug|cyclophosphamide|Postoperative: Given intravenously for four two-week cycles
12001326|NCT00580333|Drug|paclitaxel|Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)
12001327|NCT00580320|Drug|Dacarbazine and bortezomib|Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2
12001328|NCT00580307|Procedure|Septoplasty|Surgical straightening of nasal septum
12001329|NCT00580307|Procedure|Septoplasty and endoscopic contact point correction|Septoplasty (as previously described). Contact point correction: structures of the lateral nasal wall that impinge on the nasal septum are mobilized to a more lateral position under endoscopic guidance.
12001330|NCT00580294|Drug|Oxymorphone|IV PO
12001331|NCT00580281|Other|blood test, urine test, and bone density x-ray.|start of the study (month 0), and at months 3, 6, 9, 12 (1 year), 15, 18, 21, and 24 (2 years)
12001332|NCT00580242|Drug|Bortezomib|First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
12001333|NCT00580242|Drug|Bortezomib|Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
12001334|NCT00580242|Drug|Bortezomib|Third Cohort: Bortezomib 1.3mg/m2 IV on Days 1, 4, 8, and 11 of each cycle Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
12001335|NCT00580242|Drug|Lenalidomide|Lenalidomide 10 mg PO QD on Days 1 -21 followed by a 7 day rest period
12001336|NCT00580229|Drug|prednisone|prednisone 40mg by mouth 30-60 minutes prior to rituximab
12001337|NCT00580216|Drug|Idrabiotaparinux sodium|"Pre-filled syringes containing:
~0.5 mL for the 3.0 mg dosage;
~0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
~0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).
~Subcutaneous injection"
12001338|NCT00580216|Drug|Warfarin|"Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
~Oral administration"
12001339|NCT00580216|Drug|Placebo (for idrabiotaparinux)|"Matching pre-filled syringes containing:
~0.5 mL for the 3.0 mg dosage;
~0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
~0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).
~Subcutaneous injection"
12001340|NCT00580216|Drug|Placebo (for warfarin)|"Warfarin matching capsules
~Oral administration"
12001341|NCT00580216|Drug|Avidin|"Vial containing 105 mg of lyophilized powder for dilution
~Intravenous infusion for 30 minutes"
12001342|NCT00580216|Drug|Placebo (for avidin)|"Vial containing 105 mg of matching lyophilized powder for dissolution
~Intravenous infusion for 30 minutes"
12001343|NCT00580190|Drug|alprazolam|tablet, 0.5 mg, single dose, only on Day 7 of the study
12001344|NCT00580190|Other|Placebo|solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study
12001345|NCT00580190|Drug|PF-00572778|solution, 500 mg, single dose, only on Day 7 of the study
12001346|NCT00580177|Procedure|Lichtenstein mesh|The different techniques are compared and evaluated according to primary and secondary objectives.
12001347|NCT00580177|Procedure|PerFix Plug®|The different techniques are compared and evaluated according to primary and secondary objectives.
12001348|NCT00580177|Procedure|Prolene® Hernia System|The different techniques are compared and evaluated according to primary and secondary objectives.
12001349|NCT00580151|Drug|clonidine|3-5 microgram per kilogram every 6 hours for 10 days
12001350|NCT00580151|Drug|placebo|1 dose every 6 hours
12001351|NCT00580125|Drug|PF-00217830|PF-00217830 5 mg, oral capsule, once daily for 21 days
12001352|NCT00580125|Other|Placebo|Placebo, oral capsule, once daily for 21 days
12001353|NCT00580125|Drug|Aripiprazole|Aripiprazole 15 mg, oral capsule, once daily for 21 days
12001354|NCT00580125|Drug|PF-00217830|PF-00217830 15 mg, oral capsule, once daily for 21 days
12001355|NCT00580125|Drug|PF-00217830|PF-00217830 2 mg, oral capsule, once daily for 21 days
12001356|NCT00580112|Drug|Dexamethasone|Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
12001357|NCT00580112|Drug|Trabectedin|Trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
12001358|NCT00580099|Other|assisted exercise|4 weeks of passive range of motion exercise
12001359|NCT00580099|Other|cuddle|cuddle infant for 20 minutes
12001360|NCT00580086|Other|MR spectroscopy|(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI
12001361|NCT00580073|Drug|FOLFOX4|oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
12001362|NCT00580073|Drug|Cetuximab|Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
12001363|NCT00580060|Biological|GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)|In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 mg), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations.
12001364|NCT00580047|Drug|Zoledronic Acid|4mg IV Annually
12001607|NCT00578305|Drug|Folic acid or folate|
12001365|NCT00580047|Combination Product|Calcium with vitamin D|1200 mg Calcium with 800 International Units of vitamin D
12001366|NCT00580047|Drug|Alendronate|70mg weekly
12001367|NCT00580034|Drug|Campath Purged Non-myeloablative ASCT|"Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
12001368|NCT00580034|Procedure|Donor Apheresis|Donor will receive Granulocyte colony-stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
12001369|NCT00580021|Other|Genotyping|Samples for DNA extraction will be shaved from archival paraffin-embedded tissue blocks (using normal lymph node preferentially)and placed in appropriate receptacles labeled only with the subject unique study number. This material will be transported to the genotyping laboratory, where it will be stored until the clinical record abstraction is complete. Briefly, DNA will be extracted from the archive paraffin-embedded material using standard protocols and the samples will be analyzed for the presence of the Ashkenazi BRCA founder mutations using either PCR-based or gel-electrophoresis-based approaches.
12001370|NCT00579995|Drug|Oral N-Acetylcysteine|600 mg
12001371|NCT00579995|Drug|Intravenous Sodium Bicarbonate|3mL/kg/hr for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure
12001372|NCT00579982|Drug|Lamotrigine|Experimental formulation
12001373|NCT00579969|Drug|Latanoprost|dosage form:eye drops, dosage: One drop in each eye twice a day
12001374|NCT00579969|Drug|Timolol|dosage form:eye drops, dosage: One drop in each eye twice a day
12001375|NCT00579956|Drug|Meropenem|Meropenem 1gm, diluted with 50ml normal saline solution IV every 8 hours for at least 10 days. The dose will be adjusted according to the creatinine clearance.
12001376|NCT00579956|Drug|Ceftazidime|Ceftazidime 120mg/kg/day divided into 3 equal doses (maximum dose 2 gram/dose), diluted with 50ml normal saline solution IV every 8 hours for at least 10 days The dose will be adjusted according to the plasma creatinine level
12001377|NCT00579917|Behavioral|Cognitive Behavioral Therapy: Questionnaires|CBT, we will interview you again after you have completed the 10 sessions. We call these follow-up interviews, and they include several phone calls and a questionnaire you would be asked to complete and then mail in. Each follow-up interview will take between 60 and 210 minutes. If you wish, these follow-up interviews can be done over different days. We will do the follow-up interviews three times; at approximately 4 months, 7 months, and 10 months after you complete the baseline interview.
12001378|NCT00579917|Behavioral|Usual Care: Questionnaires|If you receive Usual Care, you will not receive CBT while you are in the study. You will complete the questionnaires at the same time as participants who receive CBT. If you receive Usual Care you will be offered 10 sessions of CBT at no charge at the end of the study.
12001379|NCT00579904|Dietary Supplement|walnuts|Subjects will follow their usual diet for 4 weeks; after that they will be randomized to walnuts. They will eat walnuts once daily for six weeks.
12001380|NCT00579904|Dietary Supplement|almonds|Subjects will follow their usual diet for 4 weeks; after that they will be randomized to almonds. They will eat almonds once daily for six weeks.
12001381|NCT00579878|Drug|Leflunomide|A loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations
12001382|NCT00579878|Drug|Methotrexate-Sulfasalazine-Hydroxychloroquine|"Methotrexate:
~dosing starts at 10mg/week (4 tabs/wk). If total remission (according to ACR criteria found in Appendix II) has not been achieved and the labs are acceptable at the 8-week evaluation, the dose increased to 15 mg/week (6 tabs/wk);at the 16-week evaluation, the dose increased to 20 mg/week (8 tabs/wk). This dose will remain stable until the end of the study.
~Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable,dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day)."
12001383|NCT00579878|Drug|Leflunomide-Sulfasalazine-Hydroxychloroquine|Leflunomide: dose of 100 mg (or placebo) for three (3) days. Followed by a dose of 20 mg/day will be maintained throughout the remainder of the study. dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day).
12001384|NCT00579865|Behavioral|questionnaires|complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.
12001385|NCT00579865|Behavioral|questionnaires|complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks.
12001386|NCT00579852|Procedure|CT Scan|Patients with NSCLC undergoing non-contrast CT scan of the chest will have a second, high resolution, non-contrast CT scan of the chest performed on the same day. The scans will be performed on the same CT scanner, generally within 30 minutes. Unidimensional, bi-dimensional, and volume measurements for the primary NSCLC lesion will be determined on both scans and the values compared. After completing the second scan, the patient will have completed participation in the protocol.
12001387|NCT00579839|Procedure|Delayed Cord Clamping|Delayed Cord Clamping: 30-35 seconds after birth
12001388|NCT00579839|Procedure|Immediate Cord Clamping|Immediate Cord Clamping: within 5 seconds of birth
12001389|NCT00579826|Drug|Letrozole|Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
12001390|NCT00579826|Drug|Placebo|Placebo tablet daily for 6 months then optional open label letrozole for 6 months.
12001391|NCT00579813|Drug|Pioglitazone|Pioglitazone 30mg for 2 weeks, then Pioglitazone 45mg for 8 weeks.
12001392|NCT00579800|Procedure|new software sequences, FIESTA and Vibrant-DE and IDEAL|Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients.
12001393|NCT00579774|Other|Low AGE Diet|Diet
12001394|NCT00579774|Other|Regular Diet|Diet
12001395|NCT00579709|Biological|Thymus Tissue for Transplantation|"3 Thymoglobulin doses given prior to thymus tx. Atypical subjects given Cyclosporine (Csa) pre-tx. Desired Csa concentration 180-300ng/ml. If post-tx T cell count remained <4000/cumm Csa weaned over 8 weeks. If T cell >4,000/cumm, Csa held at 180-300ng/ml.
~Thymus tissue, donor, & mother of donor were screened for transplant safety. In operating room, thymic slices were transplanted into quadriceps muscle in 1 or both legs.
~Subjects had routine blood research immune evaluations. 2-3 months post-tx, open biopsy of allograft. Immune blood studies continued on surviving subjects until January 2010. Biological Mother: Mother provided blood sample used for DNA extraction, to identify/look for maternal T cell presence in recipient pre-tx, and/or for immune testing post-tx."
12001396|NCT00579683|Other|Tumor core biopsy for RNA isolation|RNA isolation will be carried out using approximately 25 mg of gross tissue from these tumor specimens.
12001397|NCT00579670|Drug|Ziprasidone|Ziprasidone 20mg, 40mg, 60mg, 80mg capsules, hard; Ziprasidone 10 mg/ml oral suspension Ziprasidone 20mg/ml powder and solvent for the reconstitution of solution for injection
12001398|NCT00579657|Other|control diet, supported by dietary supplement twice daily|control diet, see above
12001399|NCT00579657|Other|high cereal fiber diet, supported by dietary supplement twice daily|high cereal fiber diet, see above
12001400|NCT00579657|Other|high protein diet, supported by dietary supplement twice daily|high protein diet, see above
12001401|NCT00579657|Other|diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily|MIX diet, see above
12001402|NCT00579644|Drug|Combination of Minocycline and MTX or MTX alone|"Methotrexate Dosing:
~1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week.
~3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week.
~4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg"
12001403|NCT00579644|Drug|methotrexate|"Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.
~2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week.
~4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week.
~6, 8 and 10 month evaluations:
~If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week.
~If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 12 month evaluation: End of the blinded portion of the study."
12001404|NCT00579631|Behavioral|Questionnaire or Interview|Complete a self-report survey once over the telephone or by mail. The questions are about your health beliefs and behaviors, your current health, and your mood. It should not take longer than 45 minutes to complete. About 15 of these people will participate in an additional, short audiotaped interview about sun protection.
12001405|NCT00579618|Other|Saliva or Blood samples|Extracting sample of saliva or blood only once.
12001406|NCT00579605|Behavioral|Motivational Interviewing|Client-centered strategy that may decrease ambivalence in behavior performance with attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.
12001407|NCT00579592|Drug|Campath-1H, rituximab, myfortic|Campath-1H 30mg IV x 2 doses, rituximab 375mg/m2 IV x 1 dose, myfortic 720mg bid, cyclosporine po bid (target trough 200ng/ml) x 10-20 days
12001408|NCT00579579|Behavioral|Questionaires|Prior to surgery, patients will be asked to complete baseline surveys. In addition, a random subsample of approximately 30 patients will be asked to participate in a short qualitative interview to explore expectations regarding bowel function and quality of life following surgery. Follow-up surveys will be completed at 6, 12 and 24 months after bowel continuity has been restored (defined by their last surgical procedure). Patients with a permanent stoma will receive the Stoma-specific QOL questions in place of the MSKCC Bowel Function Instrument at 6 and 12 months after initial surgery.
12001409|NCT00579566|Other|Specimen protocol|The research specimen will be obtained from the residual specimen that would otherwise be discarded per usual hospital procedure.
12001410|NCT00579553|Drug|Intramuscular Progesterone|Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
12001411|NCT00579553|Drug|Vaginal Progesterone|Vaginal Progesterone: 100 mg vaginal suppository daily
12001412|NCT00579540|Dietary Supplement|Flax Seed Oil|Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
12001413|NCT00579540|Dietary Supplement|Fish Oil|Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
12001414|NCT00579540|Dietary Supplement|Soybean Oil|Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
12001415|NCT00579527|Biological|Cultured Thymus Tissue for Implantation (CTTI)|Potential thymus recipient subjects are screened for eligibility. Thymus donor (unrelated donor), and thymus donor's birth mother are screened for safety. CTTI is done under general anesthesia in the operating room. Cultured thymus tissue is implanted into the subject's quadriceps. Two to three months post CTTI, if medically stable, the subject undergoes allograft biopsy. At the time of implantation and biopsy, a skin biopsy is done. Immunosuppression is weaned as per protocol.
12001608|NCT00578292|Drug|Busulfan|"4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg
~Days -9 through -6"
12001609|NCT00578292|Drug|Fludarabine|30mg/m2 Day -5 through Day -2
12001416|NCT00579527|Other|Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation|For subjects w/ hypoparathyroidism, the subject may receive CTTI and parathyroid transplant. For parathyroid transplant, parental parathyroid donors are screened. Parathyroid is harvested from the parent who shares the most Human Leukocyte Antigens (HLA) alleles with the thymus donor. Parathyroid gland is minced and placed in quadriceps muscle; there is no dose. Parathyroid donors are monitored as outpatients until recipients' discharge. Recipients' calcium and PTH levels are monitored indefinitely. Potential thymus recipient subjects are screened for eligibility. Thymus donor (unrelated donor), and thymus donor's birth mother are screened for safety. CTTI is done under general anesthesia in the operating room. Cultured thymus tissue is implanted into the subject's quadriceps. Two to three months post CTTI, if medically stable, the subject undergoes allograft biopsy. At the time of CTTI and biopsy, a skin biopsy is done. Immunosuppression is weaned as per protocol.
12001417|NCT00579527|Procedure|Blood Draw|Birth mothers of Thymus Recipients are asked to participate in the study and undergo phlebotomy to allow testing of T cell identity in the Complete DiGeorge subjects. If blood is not obtainable then a buccal swab may be done.
12001418|NCT00579527|Drug|Rabbit anti-thymocyte globulin|Three doses of 2 mg/kg IV (through a central venous catheter) prior to CTTI. Each dose of Rabbit anti-thymocyte globulin (RATGAM) is given over 12 hours. RATGAM is usually given on days-5, -4, and -3 prior to CTTI or CTTI and parathyroid transplantation. Medications (diphenhydramine, steroids, and acetaminophen) are given with rabbit anti-thymocyte globulin.
12001419|NCT00579527|Drug|Cyclosporine|"In addition to RATGAM, subjects with typical cDGA with PHA responses >50,000 cpm, or atypical cDGA with PHA response <75,000cpm (when not on immunosuppression) or <40,000 cpm to PHA while on immunosuppression, are started on cyclosporine (Csa) as soon as cDGA is diagnosed. Csa is continued with target trough levels of 180 to 220 ng/ml. If subject cannot tolerate Csa, Csa may be changed to tacrolimus (FK506) with target trough level 7 to 10 ng/ml. When trough levels are outside of range, dosing is modified appropriately.
~Csa may be given every 8 to 12 hours enterally or IV before and after CTTI. The Csa dose is dependent on T cell numbers and the target Csa trough levels. Csa is weaned as per protocol."
12001420|NCT00579527|Drug|Tacrolimus|If unable to tolerate cyclosporine, then tacrolimus is given. Tacrolimus may be given every 8 to 12 hours enterally or IV before and after the CTTI transplant. Tacrolimus dose is dependent on the T cell numbers and the target tacrolimus trough levels. Tacrolimus is weaned as per protocol.
12001421|NCT00579527|Drug|Methylprednisolone or Prednisolone|Steroids IV or enterally may be given before and after CTTI or CTTI and parathyroid transplantation. Administration and dosage depends on T cell numbers and symptoms. Pre-transplant steroids may be used when pre-transplant T cells >4,000cumm. Steroids are weaned as per protocol.
12001422|NCT00579527|Drug|Daclizumab|In addition, subjects with Atypical DiGeorge with PHA responses >75,000cpm while on no immunosuppression or PHA responses >40,000cpm while on immunosuppression, Daclizumab 1 mg/kg single dose IV may be given depending on T cell counts. Administration of Daclizumab depends on T cell numbers and T cell activation. A single dose may be given after the administration of rabbit anti-thymocyte globulin and before CTTI. If Daclizumab is not given before CTTI, and, depending on the T cell numbers and T cell activation, a single dose of Daclizumab may be given 3-5 days after CTTI.
12001423|NCT00579527|Drug|Mycophenolate mofetil|In addition, subjects with Atypical DiGeorge with PHA responses >75,000cpm while on no immunosuppression or PHA responses >40,000cpm while on immunosuppression, Mycophenolate mofetil 15 mg/kg/dose every 8 hours IV or enterally may be given depending on T cell counts. Mycophenolate mofetil may be given if the T cell count remains elevated 5 days after CTTI. If MMF is given, the dose is 15 mg/kg IV. MMF may be stopped at 35 days after CTTI or continued for up to six months after CTTI.
12001424|NCT00579514|Genetic|PCR/PCR/LDR Strategy|Evaluate the extent to which polymorphisms in BRCA1, BRCA2, PTEN, T β R1, TGF β-1, DNA repair genes (including ATM and CHK2), APC, ER, PR, MCP-1, MPIF, CCR2/5 and CCR3 are correlated with cancer incidence. Candidate genes will also be selected from 1) cytokine signaling and 2) apoptosis regulatory pathways.
12001425|NCT00579501|Drug|Trabectedin|Trabectedin 1.5 mg/m^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin.
12001426|NCT00579501|Drug|Dexamethasone|Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion
12001427|NCT00579475|Drug|Mifegyne|tablets, 50 mg every other day
12001428|NCT00579475|Drug|placebo|
12001429|NCT00579462|Other|Blood and Tissue studies|Blood will be collected from participating patients at baseline, as close as possible to the date of their baseline radiologic assessment. Three follow-up blood collections will be drawn, each within 7-10 days of each follow-up radiologic evaluation.
12001430|NCT00579449|Behavioral|Healthy Families Durham|Implementation of Healthy Families America program plus Parents As Teachers curriculum
12001431|NCT00579449|Behavioral|Yearly Checkup|Mother and child are assessed annually and based on responses and stated needs, referrals to community resources are made.
12001432|NCT00579436|Drug|omega-3 fatty acid|4g of omega-3 fatty acid daily by mouth for 12 weeks.
12001433|NCT00579436|Drug|placebo|4 inert capsules daily by mouth for 12 weeks.
12001434|NCT00579423|Biological|QS21|"Treatment schedule and dose: Thirty patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administered at the standard dose of 100 ug.
~Sites: The vaccine conjugate will be administered subcutaneously on a rotating basis to random sites on the upper arms and upper legs.
~Dose modifications: If a patient experiences a Grade III or greater local or Grade II or greater systemic toxicity at any time a decrease by 50% in all components of future vaccinations will be administered for that patient. Any evidence of autoimmunity, however, will result in a cessation of immunization in that patient."
12001435|NCT00579384|Drug|JNJ-26489112|Single oral dose of JNJ-26489112 up to 3000 mg on Day 2.
12001436|NCT00579384|Drug|Placebo|Single dose of placebo on Day 1, and a second single dose of placebo on Day 3.
12001437|NCT00579371|Drug|Islets of Langerhans|Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000IE/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed.
12001438|NCT00579345|Biological|Cell culture derived seasonal trivalent influenza vaccine (cTIV)|cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
12001610|NCT00578292|Drug|Campath 1H|Per institutional guidelines Days -5 through -2
12001439|NCT00579345|Biological|Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).|egg based trivalent influenza vaccine (eTIV_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
12001440|NCT00579345|Biological|cTIV or eTIV_a|0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV_a administered.
12001441|NCT00579345|Biological|cTIV+PV OR eTIV_a+PV|0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV).
12001442|NCT00579332|Dietary Supplement|brassica intervention|diet and phyto-chemical intervention
12001443|NCT00579280|Drug|quetiapine SR|flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks
12001444|NCT00579280|Drug|divalproex sodium ER|Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks
12001445|NCT00579280|Drug|placebo|placebo
12001446|NCT00579267|Other|MINI-KID|Structured Diagnostic Interview for children and adolescent psychiatric disorders.
12001447|NCT00579254|Drug|CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)|Patients who have been treated with Caduet 5/10 or 5/20 mg single pill treatment, based on their clinical conditions and latest locally approved packet insert recommendations will be eligible to be enrolled to this study
12001448|NCT00579241|Procedure|Ultrasound on Temporal Bone|All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.
12001449|NCT00579215|Behavioral|Enhance Care|EC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits
12001450|NCT00579215|Behavioral|Usual Care|As an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making. Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic.
12001451|NCT00579202|Device|Gambro HD-C4 Small Dialyzer|Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.
12001452|NCT00579189|Drug|Moxidex otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
12001453|NCT00579189|Drug|Moxifloxacin otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
12001454|NCT00579189|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
12001455|NCT00579137|Biological|Campath -1H|"Given intravenous on Days -8,-7, and -6
~Campath dose is weight based: for patients less than 15 kg the dose is 3 mg; for patients >15 kg to 30 kg the dose 5 mg; for patients > 30 kg the dose is 10 mg"
12001456|NCT00579137|Drug|Fludarabine|"Given intravenous on Days -8,-7,-6,-5, and -4
~Dose is 30 mg/m2"
12001457|NCT00579137|Biological|Anti-CD45|"Given intravenous over 6 hours on Days -5,-4,-3, and -2
~Dose is 400 microgram/kg"
12001458|NCT00579137|Procedure|Stem cell infusion|stem cells are infused on day 0
12001459|NCT00579124|Device|CliniMACs|T and B Cell depletion
12001460|NCT00579111|Drug|Campath|10 mg/day IV daily for 3 days on days -6 to D-4. Campath may be omitted from the conditioning regimen for patients with malignant diseases and matched related donor transplants
12001461|NCT00579111|Drug|Busulfan|3.2 mg/kg/day IV daily for 2 days, infused over 3 hours, on Day -5 and Day -4
12001462|NCT00579111|Drug|Fludarabine|30mg/m2/day IV daily for 4 days on Day -5 to D -2
12001463|NCT00579111|Procedure|Hematopoietic stem cell infusion|Peripheral blood stem cells when possible. Bone marrow cells will be used if peripheral blood cells are insufficient or unavailable.
12001464|NCT00579111|Drug|FK-506|FK-506 at a dose of 0.03 mg/kd/day will be administered via continuous infusion over 24 hours from 4pm on Day -2 until engraftment or when the patient is able to take PO, then 0.03 mg/kg PO every 12 hours.
12001465|NCT00579098|Drug|Atorvastatin|80 mg tablet taken by mouth daily for 90 days
12001466|NCT00579098|Drug|Placebo|Placebo tablet taken by mouth once daily for 90 days
12001467|NCT00579085|Drug|Ketamine|IV Ketamine .35mg/kg times ten days.
12001468|NCT00579085|Other|IV NSS|Placebo inactive ingredients
12001469|NCT00579085|Other|Normal Saline|"INFUSION PLAN:
~All patients will be infused intravenously with 100 ml of normal saline for four hours (25 ml/hr) daily for 10 days.Both patient arms will receive 2mg of Versed x two doses IV. They will also receive Clonidine (0.1 mg, po)"
12001470|NCT00579072|Behavioral|Questionaires|We will use a 6-month longitudinal design to assess the short-term cognitive effects of androgen ablation therapy. We will collect 6-month longitudinal data on 170 men with prostate cancer. All 170 men will be hormone naïve at the start of this study (Hormone Naïve Group). These 170 men will consist of two subgroups. The first subgroup will comprise 70 men with prostate cancer age 65 and older scheduled to start androgen ablation therapy. Their cognitive functioning will be assessed prior to starting androgen ablation therapy or within 21 days after initiation, (i.e. baseline) and then 6 months later (Androgen Ablation Subgroup).The second subgroup will serve as a control group, and consist of 100 men with prostate cancer age 65 and older who are at least 1-year post definitive localized treatment with no evidence of disease and no plan to start androgen ablation therapy (No Androgen Ablation Subgroup).
12001611|NCT00578292|Drug|Cyclophosphamide|50 mg/kg Days -5 through -2
12001612|NCT00578292|Drug|MESNA|10 mg/kg x 5 Days -5 through -2
12001471|NCT00579072|Behavioral|Questionaires|To supplement the pilot data collected in Aim 1, Aim 2 we will utilize a group comparison design to assess the long-term cognitive effects of androgen ablation therapy. We will collect data on the cognitive functioning of 110 men with prostate cancer age 65 and older who have been on continuous androgen ablation therapy for 1-3 years (2-Year Androgen Ablation Group). These men will complete the study battery once (i.e., the neuropsychological battery, psychosocial questionnaires, and a functional status battery). We will compare the cognitive functioning of these 110 men in the 2-Year Androgen Ablation Group to the 170 men with prostate cancer who are hormone naïve (Hormone Naïve Group).
12001472|NCT00579072|Device|fMRI scan (optional)|Main study participants will be offered to complete an optional fMRI. Fifteen participants from the No Androgen Ablation Subgroup and 15 participants from the Comparison Androgen Ablation Subgroup or Longitudinal Androgen Ablation Subgroup will be recruited for this portion of the study. The fMRI will be scheduled either the same day as the neurocognitive assessment or within eight weeks of the neurocognitive testing. The fMRI will be performed only once at baseline for the Comparison Androgen Ablation Subgroup. The fMRI will be performed at the follow-up time point for the Longitudinal Androgen Ablation Subgroup. The fMRI will be performed at baseline for the No Androgen Ablation Subgroup; if the fMRI can not be completed at baseline (due to participant schedule conflict, lack of fMRI availability, staff schedule conflict, etc.), then the scan will be conducted at the follow-up time point if possible.
12001473|NCT00579059|Device|Maxim® Knee System with Removable Molded Polyethylene Tibia|Used for total knee replacements
12001474|NCT00579059|Device|Regular Maxim® Knee System|Used for total knee replacements
12001475|NCT00579046|Drug|Darbepoetin alfa|"Dosage form: injection (to store between 2 and 8 °C). Dosage: various dosages are available (10, 15, 20, 30, 40, 50, 60, 80, 100, 150 or 300 µg/ml).
~Frequency: every week for 2 months: 8 injections"
12001476|NCT00579033|Other|Tactile training + sham rTMS|tactile training for 2.5/hr/day for 15 days - this plus the sham rTMS
12001477|NCT00579033|Other|Tactile training + rTMS|tactile training 2.5/hr/day for 15 days plus daily 5Hz rTMS
12001478|NCT00579020|Drug|Moxifloxacin/dexamethasone phosphate ophthalmic solution|
12001479|NCT00579020|Drug|Moxifloxacin ophthalmic solution 0.5%|
12001480|NCT00579020|Drug|Dexamethasone phosphate solution, 0.1%|
12001481|NCT00579007|Behavioral|telephone interviews|Telephone interviews take place before the first counseling appointment (baseline), and 1 week, 6 months and 12 months post-notification of the individual's genetic test results. In the event that a participant chooses not to undergo genetic testing, follow-up interviews will take place 1 month, 6 months and 12 months after the initial counseling visit.
12001482|NCT00578994|Device|Oxford® Meniscal Unicompartmental Knee System|Oxford® Meniscal Unicompartmental Knee System is a medial, unicompartmental knee prosthesis containing three components: a femoral component, a tibial component, and a tibial meniscal bearing.
12001483|NCT00578981|Behavioral|Osteoporosis Choice Decision Aid|The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
12001484|NCT00578968|Drug|Tiotropium|Participants received once daily Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device.
12001485|NCT00578968|Drug|Placebo|Participants randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose, using the HandiHaler device.
12001486|NCT00578955|Drug|1% Azithromycin and 0.1% Dexamethasone|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
12001487|NCT00578955|Drug|1% Azithromycin|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
12001488|NCT00578955|Drug|0.1% Dexamethasone|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
12001489|NCT00578942|Drug|Campath Purged Non-myeloablative ASCT|"Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
12001490|NCT00578929|Drug|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine HCl 1 or 2 sprays per nostril twice daily
12001491|NCT00578929|Drug|Vehicle|Vehicle 1 or 2 sprays per nostril twice daily
12001492|NCT00578916|Drug|EVRI (BMS-690514)|Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay
12001493|NCT00578903|Drug|Cytoxan|Cytoxan will be given at 50 mg/kg per dose for 4 successive days.
12001494|NCT00578903|Drug|Campath|Campath will be given at a dose of 3 mg for patients whose weight is between 5 and 15 kg; at a dose of 5 mg for patients whose weight is between 16 and 30 kg; and at a dose of 10 mg for patients whose weight is greater than 30 kg. The last dose of Campath should be 24 hours or more before stem cell infusion.
12001495|NCT00578903|Radiation|Total Body Irradiation (TBI)|TBI will be given at a dose of 200 cGy for 6/6 HLA match and at a dose of 400 cGy in two fractions of 200 cGy each for 5/6 HLA matched donor.
12001496|NCT00578903|Drug|FK-506|FK-506 will be given at a dose of 0.03 mg/kg/day via continuous infusion over 24 hours from 4pm on day -2 until engraftment or when patient is able to take by mouth (PO), then 0.03 mg/kg PO every 12 hours.
12001497|NCT00578903|Drug|Methotrexate|Methotrexate will be administered on day +1, day +3, day +6 and day +11 at a dose of 5 mg/m2. The day +11 dose may be omitted at the discretion of the bone marrow transplant (BMT) in-patient attending physician.
12001498|NCT00578903|Procedure|Stem cell infusion|Where possible patients will receive bone marrow. Marrow will be collected as per National Marrow Donor Program (NMDP) guidelines to provide a volume of 15-20 ml/kg of marrow and/or 2-4 X 10^8 nucleated cells/kg. In case marrow cannot be collected, peripheral blood stem cell (PBSC) will be substituted. A minimum of 5-6 X 10^6 CD 34+ cells/kg should be collected, with a target of 10 X 10^6/kg.
12001499|NCT00578890|Procedure|Medical/surgical treatment versus medical treatment|A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.
12001500|NCT00578877|Device|SILCS Diaphragm|SILCS Diaphragm used with 5 ml gel
12001501|NCT00578877|Combination Product|Nonoxynol-9 Gel|Gynol II (2% N-9 gel)
12001502|NCT00578877|Combination Product|Buffer Gel|Buffer Gel
12001651|NCT00577993|Drug|Doxorubicin|25 mg/m^2 IV Days 2 & 3 of 1st Sequence.
12001503|NCT00578864|Drug|Protracted Oral Etoposide|"Cisplatin with Oral Protracted Etoposide for cycles 1, 2 and 4
~Day 1 - 5
~Hour 0: Etoposide 50 mg/m2 po daily
~Hours 1 to 7: Cisplatin 40 mg/m2
~Day 6 - 14
~Etoposide 50 mg/m2 po once daily"
12001504|NCT00578864|Drug|Doxorubicin|"Given together with cyclophosphamide for cycle 3 and 5 of induction chemotherapy Day 1 and 2
~Hours 0 to 6: Cyclophosphamide 2000 mg/m2 (67 mg/kg if < 12 kg) with Mesna 400 mg/m2 (13 mg/kg if < 12 kg) in D5½NS 600 mL/m2 IV over 6 hours to run at 100 mL/m2/hr
~Hours 6 to 6.25: Doxorubicin 37.5 mg/m2 (1.25 mg/kg if < 12 kg) IV over 15 minutes"
12001505|NCT00578864|Drug|IV Bolus Etoposide|"Cisplatin with Bolus IV Etoposide
~Day 1
~Hours 0 to 6: Cisplatin 40 mg/m2
~Days 2, 3, 4:
~Hours 0 to 1: Etoposide 200 mg/m2 Hours 1 to 7: Cisplatin 40 mg/m2
~Day 5:
~Hours 0 to 6: Cisplatin 40 mg/m2"
12001506|NCT00578864|Drug|Cisplatin|Cycle 1, 2, and 4
12001507|NCT00578864|Drug|Cyclophosphamide|Cycle 3 and 5 with doxorubicin
12001508|NCT00578864|Drug|Mesna|Standard weight-based dosing with cyclophosphamide
12001509|NCT00578864|Drug|Hematopoietic Factor|Standard weight-based dosing after cycle 3 and 5 and if needed for neutropenic recovery after cycles 1,2 and 4
12001510|NCT00578864|Procedure|Primary tumor resection|Resection of primary tumor after cycle 3, 4, or 5 as clinically appropriate
12001511|NCT00578851|Device|C2a - Taper™ Acetabular System|The C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners.
12001512|NCT00578838|Other|Magnetic Resonance|Patients each will undergo 4 MR examinations as part of this research study.
12001513|NCT00578838|Other|Magnetic Resonance|You will have two MR exams on two different days. There will be no injection of contrast material. An MR exam requires about 1 hour. The second MR exam will take place 2-3 weeks after the first one. This second MR exam will take about 1 hour and will look at whether the results from the MR exams are reliable and repeatable.
12001514|NCT00578825|Drug|Lopinavir / Ritonavir plus Ribavirin|
12001515|NCT00578812|Device|Anterior Cervical Discectomy and Fusion (ACDF)|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
12001516|NCT00578812|Device|PCM Cervical Disc|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
12001517|NCT00578799|Dietary Supplement|Kyo-Dophilus|5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening
12001518|NCT00578799|Dietary Supplement|placebo|placebo capsules (potato starch
12001519|NCT00578786|Drug|ambrisentan|2.5, 5.0 or 10.0 mg ambrisentan po, qd, long-term
12001520|NCT00578773|Drug|Moxidex otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
12001521|NCT00578773|Drug|Moxifloxacin otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
12001522|NCT00578773|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
12001523|NCT00578760|Drug|aspirin|325mg ASA OD for the duration of the cisplatin
12001524|NCT00578760|Drug|placebo|OD for course of cisplatin chemotherapy
12001525|NCT00578734|Drug|Lucinactant|Slow intra-tracheal instillation
12001526|NCT00578734|Other|Sham Comparator|Slow intra-tracheal instillation
12001527|NCT00578721|Drug|Aspirin|325 mg taken daily with an arginine-restricted diet
12001528|NCT00578708|Device|AMPLATZER Membranous VSD Occluder|Device closure with the AMPLATZER Membranous VSD Occluder
12001529|NCT00578695|Drug|lixivaptan|Oral Capsule
12001530|NCT00578695|Drug|Placebo|Oral Capsule
12001531|NCT00578682|Biological|MEDI-557|Single IV dose of 3 mg/kg
12001532|NCT00578682|Biological|MEDI-557|Single IV dose of 15 mg/kg
12001533|NCT00578682|Biological|MEDI-557|Single IV dose of 30 mg/kg
12001534|NCT00578682|Biological|MEDI-557|Single IV dose of 0.3 mg/kg
12001535|NCT00578669|Drug|Fluoxetine|20mg once daily for 16 weeks
12001536|NCT00578669|Drug|Dextrose|Once daily for 16 weeks
12001537|NCT00578656|Dietary Supplement|Baked Milk|Extensively heated milk
12001538|NCT00578643|Drug|Busulfan|"Days -9 through -6
~1 mg/kg initially (based on weight)"
12001539|NCT00578643|Biological|Alemtuzumab|"Day -5 through Day -2
~Dose is based on weight:
~Less than 15 kg: 3 mg
~More than 15 kg to 30 kg: 5 mg
~More than 30 kg: 15 mg"
12001540|NCT00578643|Drug|Cyclophosphamide|"Days -5 through -2
~50 mg/kg"
12001541|NCT00578643|Drug|Fludarabine|"Day -5 through Day -2
~30 mg/m^2"
12001542|NCT00578643|Drug|Cyclosporine|Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.
12001543|NCT00578643|Procedure|Stem Cell Infusion|Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
12001544|NCT00578630|Other|buccal swabs and obtaining peripheral blood|will be the collection of normal cells and assessments of toxicity following chemotherapy at routine clinic visits.
12001545|NCT00578617|Drug|Rate Control|Metoprolol 50-100mg
12001546|NCT00578617|Device|Ablation Therapy|
12001547|NCT00578617|Drug|Rate Control|Atenolol 50-100mg,
12001548|NCT00578617|Drug|Rate control|Propranolol 40-80mg
12001549|NCT00578617|Drug|Rate control|Acebutolol 200mg
12001550|NCT00578617|Drug|Rate control|Carvedilol 6.25mg
12001551|NCT00578617|Drug|Rate Control|Diltiazem 180-240mg
12001552|NCT00578617|Drug|Rate Control|Verapamil 180-240mg
12001553|NCT00578617|Drug|Rate Control|Digoxin 0.125mg
12001554|NCT00578617|Drug|Rhythm Control|Propafenone 450mg
12001555|NCT00578617|Drug|Rhythm control|Flecainide 200mg
12001556|NCT00578617|Drug|Rhythm control|Sotalol 240mg
12001557|NCT00578617|Drug|Rhythm control|Dofetilide 500mcg
12001558|NCT00578617|Drug|Rhythm control|Amiodarone 200mg
12001559|NCT00578617|Drug|Rhythm control|Quinidine 600-900mg
12001560|NCT00578604|Device|diffuse near infrared spectroscopy measurements|Measure blood flow to diabetic wounds
12001613|NCT00578279|Drug|dehydrated alcohol|subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure
12001561|NCT00578591|Drug|Rituximab|"Rituximab 375 mg/m^2 is given weekly X 4. For patients with a partial response, an additional 4 doses will be permitted as needed (after 4 weeks from the last dose).
~Diagnosis of grade II to IV aGVHD will be confirmed, whenever possible, by a biopsy taken from at least one of the following three sites: skin, gut, or liver."
12001562|NCT00578578|Dietary Supplement|eicosapentaenoic acid (EPA),|three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks
12001563|NCT00578565|Drug|Rituximab|Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months.
12001564|NCT00578552|Drug|Placebo|Placebo pill - non active sugar pill designed to look alike to the gabapentin medication
12001565|NCT00578552|Drug|Gabapentin - 1800 mg/day|gabapentin - 1800 mg/day for 12 weeks.
12001566|NCT00578552|Drug|Gabapentin - 2700 mg/day|gabapentin - 2700 mg/day for 12 weeks.
12001567|NCT00578539|Drug|ARA C|Ara C (3000 mg/m2) IV every 12 hours for 6 doses (days -8 to -5)
12001568|NCT00578539|Drug|Cyclophosphamide|Cyclophosphamide (45mg/kg) IV once daily on day -7 and day -6
12001569|NCT00578539|Drug|MESNA|MESNA (45mg/kg; divided into 5 doses) will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.
12001570|NCT00578539|Radiation|Total Body Irradiation (TBI)|TBI: total dose 14.0 Gy, will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1
12001571|NCT00578539|Biological|Campath-1h|CAMPATH (3 mg IV for patients between 5 and 15 kg; 5 mg for patients between 16 and 30 kg; and 10 mg for patients greater than 30 kg) will be given on day -4, day -3, day -2 and day-1.
12001572|NCT00578539|Procedure|Stem Cell Infusion|Stem cells are infused on day 0
12001573|NCT00578526|Drug|SU011248|50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
12001574|NCT00578526|Drug|Placebo|50 mg capsule OD PO for 28 days then 14 days rest until disease progression
12001575|NCT00578500|Procedure|ovarian transplantation|Patients will undergo laparoscopic oophorectomy, aspiration of oocytes and maturation followed by cryopreservation. In case of ovarian failure and approval by treating physicians, restoration of fertility will be attempted by thawing of oocytes or by transplantation of ovarian cortex to induce ovulation and obtain oocytes for fertilization and embryo transfer.
12001576|NCT00578474|Drug|Moxidex otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
12001577|NCT00578474|Drug|Ofloxacin otic solution|5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
12001578|NCT00578474|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
12001579|NCT00578461|Drug|Ara C|3000 mg/m^2 - pts will recieve via IV every 12 hours for 6 doses starting at 20:00 hours on day -8
12001580|NCT00578461|Drug|Mesna|45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide
12001581|NCT00578461|Drug|Cyclophosphamide|45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours
12001582|NCT00578461|Radiation|TBI-Total Body Irradiation|Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4
12001583|NCT00578448|Drug|Belatacept|IV infusion
12001584|NCT00578435|Procedure|Busulfan, Cyclophosphamide, BMD|Busulfan 0.8 or 1 mg/Kg/day Days 8-6 Cyclophosphamide 50 mg/Kg/day Days 2-5 BMT Day 0
12001585|NCT00578422|Other|Ivus (Intravascular Ultrasound) of Amputation Specimens|Human lower extremity arterial segments will be obtained at autopsy and from amputation specimens. All imaging studies and vessel fixation will be undertaken immediately upon vessel procurement; in most cases this will occur within 2 hours of dissection and within 24 hours of death. The ex vivo portion of the study will make use of 150 excised vessels obtained over a 48-month period from randomly selected autopsy cases. From these vessels we expect to collect data from a minimum of 560 plaques
12001586|NCT00578422|Procedure|IVUS (Intravascular Ultrasound)|Standard diagnostic arteriographic images will be obtained. Appropriate oblique views will be acquired at the common femoral bifurcation. Next, IVUS will be performed obtaining ultrasound data from a 10 cm lower extremity artery.
12001587|NCT00578396|Dietary Supplement|grapes|1 pound of seedless red grapes
12001588|NCT00578396|Dietary Supplement|grapes|2/3 lb/day fresh red grapes
12001589|NCT00578396|Dietary Supplement|grapes|1/3 lb/day fresh red grapes
12001590|NCT00578383|Device|Low Field Magnetic Stimulation Device|The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.
12001591|NCT00578370|Drug|Ciclosporin 0.5% (Formulation 01B)|Cutaneous emulsion 200µl once a day (26 days)
12001592|NCT00578370|Drug|Ciclosporin 1.5% (Formulation 02B)|Cutaneous emulsion 200µl once a day (26 days)
12001593|NCT00578370|Drug|0.1% betamethasone|Solution 200µl once a day (26 days)
12001594|NCT00578370|Drug|0.005% calcipotriol|Solution 200µl once a day (26 days)
12001595|NCT00578370|Drug|Formulation 00B|Cutaneous emulsion (Vehicle to Formulation 01B and Formulation 02B) 200µl once a day (26 days)
12001596|NCT00578357|Behavioral|personalized feedback intervention|personalized feedback will be sent to participants after they complete and return self-help materials/questionnaires
12001597|NCT00578344|Drug|Busulfan|Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
12001598|NCT00578344|Biological|Campath 1H|Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
12001599|NCT00578344|Drug|Cyclophosphamide and MESNA|Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
12001600|NCT00578331|Drug|Olopatadine 0.6% nasal spray|2 sprays each nostril twice daily
12001601|NCT00578331|Drug|Placebo Nasal Spray|2 sprays each nostril twice daily
12001602|NCT00578318|Behavioral|Motivational Interviewing Active|Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.
12001603|NCT00578305|Biological|Rituximab|Rituximab was supplied as a sterile liquid for iv administration.
12001604|NCT00578305|Drug|Placebo|Placebo was supplied as a sterile liquid in single-use vials for iv administration.
12001605|NCT00578305|Drug|Methylprednisolone|
12001614|NCT00578266|Drug|Cyclophosphamide,Campath IH and TBI|"DAY 5 TREATMENT
~6 5 CYTOXAN 50 mg/kg WITH MESNA
~5 CYTOXAN 50 mg/kg WITH MESNA;
~4 CYTOXAN 50 mg/kgWITH MESNA; CAMPATH 3-10 mg
~3 CYTOXAN 50 mg/kg WITH MESNA; CAMPATH;
~2 TBI; CAMPATH; TACROLIMUS
~1 TBI (second fraction); CAMPATH (am) 0 STEM CELL INFUSION (pm)"
12001615|NCT00578227|Biological|Cervarix™|Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
12001616|NCT00578227|Biological|Twinrix ™ Paediatric|Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
12001617|NCT00578214|Drug|Randomized Midazolam|Midazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup.
12001618|NCT00578214|Other|Placebo|The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.
12001619|NCT00578214|Drug|Local Anesthesia|Lidocaine 1% with 1:100,000 epinephrine
12001620|NCT00578214|Drug|Prospective Midazolam|Midazolam was prepared in a 2 mg/ml cherry flavored syrup. Dosing in the prospective arm was based on weight (>45 to 77 kg, 10 mg; >77 to 100 kg, 15 mg; greater than or equal to 100 kg, 20 mg). In the prospective arm patients were given additional doses of midazolam as necessary (in 5 mg increments) to achieve and maintain the desired level of anxiolysis.
12001621|NCT00578201|Drug|radiochemotherapy,combination Cetuximab-FOLFOX|objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX
12001622|NCT00578175|Biological|Priorix-Tetra™ (MMRV vaccine 208136)|One subcutaneous injection.
12001623|NCT00578175|Biological|ProQuad®|One subcutaneous injection.
12001624|NCT00578175|Biological|Havrix®|Two intramuscular injections.
12001625|NCT00578175|Biological|Prevnar®|One intramuscular injection.
12001626|NCT00578162|Behavioral|we will screen potential agencies using our CALL SCRIPT and our AGENCY SCREENER|A cancer care facility or 'agency' is the study's unit of analysis. Data about participating agencies will be collected by electronic survey. Agencies will be identified using the NYSDOH's existing mailing list of care facilities located in the five boroughs of New York City, referral databases and resource guides created by the American Cancer Society (ACS), the New York Hospital Directory
12001627|NCT00578149|Drug|Bevacizumab|
12001628|NCT00578149|Drug|Carboplatin|
12001629|NCT00578149|Drug|Paclitaxel|
12001630|NCT00578136|Drug|Bupivacaine|Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.
12001631|NCT00578123|Behavioral|Quality of Life Questionnaires|Three surveys you will need to complete. We will give you the surveys during your regularly scheduled clinic visits at three, six, and twelve months after surgery. You will NOT be asked to make additional appointments just for the study. You will have the option of completing some of the surveys in an easy to use computer format in the clinic waiting area or on paper.
12001632|NCT00578110|Device|Glaucoma Diagnosis, Name: Neucodia|Sensitivity and Specificity
12001633|NCT00578097|Biological|Botulinum toxin type A|Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
12001634|NCT00578097|Drug|Placebo|Single injection cycle, intradetrusor injection at baseline (visit 2).
12001635|NCT00578071|Drug|Panitumumab|Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.
12001636|NCT00578071|Drug|Capecitabine|Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation
12001637|NCT00578071|Drug|Oxaliplatin|Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation
12001638|NCT00578071|Radiation|Radiation Therapy (RT)|Daily for 6 weeks
12001639|NCT00578058|Other|Counseling and Sound Therapy|Tinnitus counseling and sound therapy
12001640|NCT00578045|Procedure|Transfusion|Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood
12001641|NCT00578032|Behavioral|Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative Assessment|All patients will complete the predefined questionnaires at the following four time points along the course of their care: preoperative clinic visit, and 3 months (±1 month), 6 months (±1), and 9 months (1 and +3) post-operatively. Completion of the questionnaires should take approximately 30 minutes
12001642|NCT00578019|Procedure|IM Nailing|Patients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith & Nephew supracondylar nail.
12001643|NCT00578019|Procedure|LISS|Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA).
12001644|NCT00578006|Behavioral|Questioners|The investigators will ask you to fill out a brief paper questionnaire periodically to tell us how you are feeling, and how satisfied you are with your care.
12001645|NCT00578006|Behavioral|STAR website|You can report your symptoms every time you come to Sloan-Kettering for an appointment or chemotherapy.
12001646|NCT00577993|Drug|Fludarabine|Group 1= 25 mg/m^2 IV over 15 min. Days 2 through 4 for 8 Cycles; Group 2 = 25 mg/m^2 IV over 15 min. Days 1 through 3 for 8 Cycles.
12001647|NCT00577993|Drug|Novantrone|Group 1 = 10 mg/m^2 IV over 15 min. Day 2 for 8 Cycles; Group 2 = 10 mg/m^2 IV over 15 min. Day 1 for 8 Cycles; Group 3 = 10 mg/m^2 IV over 15 min. Day 2 of 3rd Sequence.
12001648|NCT00577993|Drug|Decadron|Group 1 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 2 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 3 = 40 mg PO Days 1 through 4 of 1st Sequence; After Completion of 3 Sequences, Days 1 through 3 Every Month for 1 Year.
12001649|NCT00577993|Drug|Rituximab|Group 1 = 375 mg/m^2 IV Days 1 through 8 of Course 1, then Day 1 Only of Cycles 2 through 5; Group 2 = 4 Months after IFN Starts, 375 mg/m^2 IV Once Per Month for 6 Months; Group 3 = 375 mg/m^2 IV Days 1 through 8 of 1st Sequence; 375 mg/m^2 IV Days 1 through 8 of 3rd Sequence.
12001650|NCT00577993|Drug|Interferon|Group 1 = After Completion of Fludarabine, Novantrone, & Rituximab, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 2 = After Completion of Fludarabine & Novantrone, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 3 = After Completion of 3 Sequences, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year.
12001652|NCT00577993|Drug|Vincristine|.7 mg/m^2 IV Days 2 & 3 of 1st Sequence; 1.4 mg/m^2 IV Day 2 of 3rd Sequence.
12001653|NCT00577993|Drug|Bleomycin|5 unit/m^2 IV Days 2 & 3 of 1st Sequence.
12001654|NCT00577993|Drug|Cyclophosphamide|750 mg/m^2 IV Day 2 of 1st Sequence.
12001655|NCT00577993|Drug|Etoposide|40 mg/m^2 IV Days 1 through 4 of 2nd Sequence.
12001656|NCT00577993|Drug|Cisplatin|25 mg/m^2 IV Days 1 through 4 of 2nd Sequence
12001657|NCT00577993|Drug|Ara-C|1.5 gm/m^2 IV Day 5 of 2nd Sequence.
12001658|NCT00577993|Drug|Methyl-Prednisolone|500 mg IV Days 1 through 5 of 2nd Sequence.
12001659|NCT00577993|Drug|Procarbazine|100 mg/m^2 PO Days 2 through 11 of 3rd Sequence.
12001660|NCT00577993|Drug|Prednisone|100 mg PO Days 1 through 5 of 3rd Sequence.
12001661|NCT00577980|Drug|Testosterone|Initial dose of Testosterone 200 mg IM administered followed by 200 mg - 400 mg every 2 weeks.
12001662|NCT00577967|Drug|Gabapentin|
12001663|NCT00577954|Procedure|Multimodal MRI|Multimodal MRI
12001664|NCT00577915|Other|Radiology/MRI scan|MRI spectroscopy
12001665|NCT00577902|Other|Observation|Head and neck cancer patients receiving chemoradiation
12001666|NCT00577889|Drug|gemcitabine hydrochloride|750 mg/m2 Given IV
12001667|NCT00577889|Drug|tanespimycin|154 mg/m2 Given IV
12001668|NCT00577876|Procedure|Trimix Injection with Doppler Ultrasound|"In case a large APA was identified, it will be dissected following the usual technique. Upon completion of the dissection, patients will have intracavernosal injection of 10 units (0.1 ml) of a Trimix administered (PGE1 10 mcg/ml, papaverine hydrochloride 30 mg/mL and phentolamine mesylate 1mg/mL.
~Once the patient achieves a pharmacologic erection, the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion."
12001669|NCT00577863|Drug|teriparatide|Subcutaneous injection of teriparatide 20 micrograms once daily using the Forteo B Pen. The primary phase of the study is 8 weeks after which time patients may participate in a study extension until the patient completes their maximum duration of teriparatide therapy or the Forteo B Pen becomes commercially available.
12001670|NCT00577850|Drug|risedronate|0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks followed by another 14C-labeled risedronate followed weekly by 35 mg risedronate for 3 weeks
12001671|NCT00577850|Drug|alendronate|0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks
12001672|NCT00577837|Drug|risedronate|tablet, 5 mg risedronate daily for 6 months
12001673|NCT00577837|Drug|risedronate|tablet, 100 mg risedronate monthly for 6 months
12001674|NCT00577837|Drug|risedronate|tablet, 150 mg risedronate monthly for 6 months
12001675|NCT00577837|Drug|experimental|tablet, 200 mg risedronate monthly for 6 months
12001676|NCT00577824|Drug|exenatide|subcutaneous injection, 5mcg, twice a day
12001677|NCT00577824|Drug|exenatide|subcutaneous injection, 10mcg, twice a day
12001678|NCT00577824|Drug|placebo|subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day
12001679|NCT00577798|Drug|doxorubicin hydrochloride|Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lyphoma and Hogdkin's lymphoma
12001680|NCT00577798|Procedure|contrast-enhanced magnetic resonance imaging|Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).
12001681|NCT00577785|Other|tissue procurement|No intervention. Tissue procurement study.
12001682|NCT00577772|Drug|Xifaxan|Open-Label Treatment at 400 mg by mouth, 3 times a day, for 7 days; only for those symptomatic and positive SBBO patients.
12001683|NCT00577772|Device|SmartPill|The SmartPill is a single-use, ingestible capsule that utilizes sensor technology to measure pressure, pH and temperature throughout the entire GI tract. The ACT-1 (SmartPill) GI Monitoring System includes an ingestible capsule, a receiver and video display software.
12001684|NCT00577772|Procedure|Lactulose hydrogen breath test (H_2BT)|A hydrogen breath test provides information about the digestion of certain sugars or carbohydrates, such as milk sugar (lactose) or fruit sugar (fructose). The test is also used for detecting abnormal growth of bacteria within the small bowel by having the patient ingest lactulose.
12001685|NCT00577759|Other|Active Intervention|Quality improvement activities, including monthly teleconferences and chart audit with feedback, to help practices refer to community resources
12001686|NCT00577759|Other|Passive Intervention|Provision of tools to help with referrals to community resources
12001687|NCT00577759|Other|No intervention|No intervention
12001688|NCT00577720|Drug|risedronate|35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
12001689|NCT00577720|Drug|risedronate|35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
12001690|NCT00577720|Drug|risedronate|50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
12001691|NCT00577720|Drug|risedronate|50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks
12001692|NCT00577707|Drug|erlotinib|One tablet daily of erlotinib pills (150 mg daily) for the first 21 days. After surgery, you will be asked to take adjuvant erlotinib 150 mg po daily x 2 years.
12001693|NCT00577707|Drug|Pemetrexed|pemetrexed 500 mg/m^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.
12001694|NCT00577707|Drug|Cisplatin|cisplatin 75 mg/m^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.
12001695|NCT00577707|Procedure|Resection|
12001696|NCT00577694|Drug|clofarabine|Intravenous, 20mg/m2, Days 1, 2, 3, 4 and 5; 2 cycles
12001697|NCT00577694|Drug|gemtuzumab ozogamicin|Intravenous, 3mg/m2, Day 1, one cycle
12001698|NCT00577681|Drug|Antiretroviral Therapy (ART)|Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.
12001699|NCT00577668|Drug|Melphalan, Velcade, Thalidomide, Dexamethasone|To assess, in patients with one or two prior auto transplants, the efficacy of a high-dose combination chemotherapy with MEL 300 (in 3 fractions of 100 mg/m2 on days -7, -4, -1) plus VTD (Velcade = bortezomib 1.3 mg/m2 on days -7, -4, -1; Thalidomide 200 mg/d on days -1 through -7; Dexamethasone 40 mg on days -7, -6, -4, -3, -1, 0) followed by autologous peripheral blood stem cell (PBSC) infusion of a minimum dose of 3 million CD34 cells/kg.
12001700|NCT00577655|Drug|Albuterol|Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.
12001701|NCT00577655|Drug|Placebo|Placebo HFA MDI four times a day (q.i.d) for 21 days.
12001702|NCT00577655|Drug|Proventil® HFA|Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.
12001703|NCT00577642|Drug|Zoledronic acid|4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
12001704|NCT00577629|Drug|cyclophosphamide|1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
12001705|NCT00577629|Drug|etoposide|300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.
12001706|NCT00577629|Drug|rituximab|375mg/m2 each week x 4 weeks of induction, beginning on day 1
12001707|NCT00577629|Drug|cytarabine|3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
12001708|NCT00577629|Drug|doxorubicin|45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
12001709|NCT00577629|Drug|tositumomab|450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.
12001710|NCT00577616|Procedure|Endovascular repair|Endovascular repair of the asymptomatic aneurysms of the abdominal aorta
12001711|NCT00577603|Procedure|mesh reinforcement of stoma|Patients randomized to receive mesh will undergo stoma formation and will have a 8 cm x 12 cm piece of AlloDerm graft placed as a tissue reinforcement around the stoma and extending under the midline incision. The mesh will be trimmed to provide a minimum of 3cm of overlap around the stoma in all directions. The mesh will be secured with transabdominal number one Prolene (Ethicon, Inc) sutures every 4cm around the mesh. Additional fixation will be provided with Protack spiral tacks (US Surgical, Inc) every 1cm around the mesh. The midline fascia will be closed with running number one Prolene sutures. Skin will be closed in standard fashion.
12001712|NCT00577603|Other|no intervention|
12001713|NCT00577590|Drug|Metformin|Metformin is taken alone
12001714|NCT00577590|Drug|Rosiglitazone|Rosiglitizone is taken with Metformin
12001715|NCT00577590|Drug|Lovaza|Lovaza is taken with Metformin
12001716|NCT00577577|Drug|rhIGF-I/rhIGFBP-3|1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.
12001717|NCT00577577|Drug|placebo|1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.
12001718|NCT00577512|Drug|DTPACE|"Dexamethasone 200 mg Intravenous Infusion Piggy-Back (IVPB) Days 1-7
~Thalidomide 200 mg by mouth (PO) Days 1-7
~Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency)
~Adriamycin 15 mg/m2 Days 1-4
~Cyclophosphamide 600 mg/m2 Days 1-4
~Etoposide 60 mg/m2 Days 1-4"
12001719|NCT00577473|Drug|mesalamine|mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
12001720|NCT00577473|Drug|mesalamine|mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
12001721|NCT00577460|Drug|Pramipexole|Pramipexole ER 0.375 -4.5 mg
12001722|NCT00577460|Drug|Placebo|Placebo tablets identical to Pramipexole ER tablets
12001723|NCT00577447|Dietary Supplement|docosahexaenoic acid (DHA)|Capsule containing 200mg of DHA
12001724|NCT00577447|Dietary Supplement|Placebo|Placebo capsule containing corn and soybean oil
12001725|NCT00577421|Drug|risedronate|5 mg tablet of risedronate once a day for 2 years
12001726|NCT00577408|Drug|depot naltrexone|On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
12001727|NCT00577408|Drug|Oral Naltrexone|For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
12001728|NCT00577395|Drug|placebo|oral tablet once a month for 12 months
12001729|NCT00577395|Drug|risedronate|tablet, 150 mg once a month for 12 months
12001730|NCT00577382|Drug|Sunitinib|
12001731|NCT00577369|Other|Desflurane Levels|The subject's participation will take place over one surgical procedure. It will begin with the first blood collection and end with either the second blood draw or the end of the procedure.
12001732|NCT00577356|Drug|Docetaxel|Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.
12001733|NCT00577356|Biological|CG1940/CG8711|Immunotherapy allogeneic GM-CSF secreting cellular vaccine
12001734|NCT00577330|Dietary Supplement|Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)|Twice daily
12001735|NCT00577317|Procedure|Management of Therapy Complications|Receive standard home maintenance therapy and perform self-manual lymphatic drainage
12001736|NCT00577317|Procedure|Management of Therapy Complications|Receive Flexitouch home maintenance therapy
12001737|NCT00577317|Other|Quality-of-Life Assessment|Ancillary studies
12001787|NCT00577057|Drug|Cisplatin|
12001788|NCT00577057|Drug|5-fluorouracil|
12001789|NCT00577057|Drug|Capecitabine|
12001790|NCT00577031|Drug|bevacizumab [Avastin]|7.5mg iv on day 1 of each 3 week cycle
12001791|NCT00577031|Drug|Oxaliplatin|130mg/m2 iv on day 1 of each 3 week cycle
12001738|NCT00577304|Drug|Nitroglycerin|Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix with Nitroglycerin. Each dose contains 4.5mg of Nitroglycerin. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
12001739|NCT00577304|Drug|Topical AmphiMatrix|Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
12001740|NCT00577278|Biological|rituximab|Given IV
12001741|NCT00577278|Drug|fludarabine phosphate|Given IV
12001742|NCT00577278|Drug|melphalan|Given IV
12001743|NCT00577278|Drug|sirolimus|Given PO
12001744|NCT00577278|Drug|tacrolimus|Given PO or IV
12001745|NCT00577278|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo APBSCT
12001746|NCT00577278|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
12001747|NCT00577278|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
12001748|NCT00577278|Other|laboratory biomarker analysis|Correlative Studies
12001749|NCT00577200|Drug|Midazolam|Midazolam
12001750|NCT00577200|Drug|Sufentanil|Sufentanil
12001751|NCT00577200|Drug|Propofol|Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
12001752|NCT00577187|Device|EnSite NavX-Guided CRT implant|LV lead placement during CRT implant using EnSite NavX
12001753|NCT00577161|Drug|fludarabine and rituximab|days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
12001754|NCT00577161|Drug|fludarabine, rituximab, pixantrone|days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only
12001755|NCT00577148|Drug|Rimonabant|Tablet, oral administration
12001756|NCT00577148|Drug|Placebo (for Rimonabant)|Tablet, oral administration
12001757|NCT00577135|Drug|Furosemide-Q12 hour bolus|Q12 hours bolus
12001758|NCT00577135|Drug|Furosemide-Continuous Infusion|Continuous infusion
12001759|NCT00577135|Drug|Furosemide-Low Intensification|1x oral dose
12001760|NCT00577135|Drug|Furosemide-High Intensification|2.5x oral dose
12001761|NCT00577122|Drug|Medroxyprogesterone progesterone acetate (MPA)|1000 mg po daily
12001762|NCT00577122|Drug|Medroxyprogesterone with Cyclophosphamide + Methotrexate|Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week
12001763|NCT00577109|Drug|bevacizumab [Avastin]|5mg/kg iv on day 1 of each 2 week cycle
12001764|NCT00577109|Drug|Irinotecan|180mg/m2 iv on day 1 of each 2 week cycle
12001765|NCT00577109|Drug|Leucovorin|200mg/m2 iv on day 1 of each 2 week cycle
12001766|NCT00577109|Drug|5 FU|400mg/m2 iv on day 1 of each 2 week cycle
12001767|NCT00577109|Drug|Cetuximab|Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle
12001768|NCT00577096|Drug|Epoetin Alfa|Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg og body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl.
12001769|NCT00577096|Behavioral|Exercise|A home-based individualized exercise program that incorporated aerobic and strength resistance training.
12001770|NCT00577096|Biological|Autologous Peripheral Blood Stem Cell Transplantation|Standard PBSCT for multiple myeloma
12001771|NCT00577096|Biological|Red Blood Cell Transfusion|RBC Transfusion was administered as needed
12001772|NCT00577096|Drug|Thalidomide|Fifty percent of the participants received 400 mg daily
12001773|NCT00577096|Drug|Heparin, Low-Molecular-Weight|Patients who received thalidomide also received prophylactic low molecular weight heparin
12001774|NCT00577096|Biological|Platelet Transfusion|Platelet transfusions were administered as needed
12001775|NCT00577096|Drug|Melphalan|Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
12001776|NCT00577096|Drug|Epoetin Alfa|Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl
12001777|NCT00577096|Drug|Total Therapy II|Standard Induction chemotherapy care included: vincristine, doxorubicin, and dexamethasone (VAD) (0.5 mg, 10 mg/m2, and 40 mg, respectively);dexamethasone, cyclophosphamide,etoposide, and cisplatin (DCEP) (40 mg, 400 mg/m2, 40 mg/m2, and 15 mg/m2,respectively); and cyclophosphamide,doxorubicin, and dexamethasone (CAD) (750 mg/m2, 15 mg/m2, and 40 mg, respectively) for mobilization.
12001778|NCT00577096|Biological|Red Blood Cell Transfusion|RBC Transfusion was administered as needed
12001779|NCT00577096|Drug|Thalidomide|Fifty percent of participants received 400 mg daily
12001780|NCT00577096|Drug|Heparin, Low-Molecular-Weight|Patients who received thalidomide also received prophylactic low molecular weight heparin
12001781|NCT00577096|Biological|Platelet Transfusion|Platelet transfusions were administered as needed
12001782|NCT00577096|Drug|Melphalan|Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
12001783|NCT00577083|Device|Cap-fitted colonoscopy|Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.
12001784|NCT00577070|Device|TMS|Transcranial Magnetic Stimulation (TMS) is a new tool in neuropsychiatry. This method is based on creating pre determined magnetic fields, which alternate rapidly. The magnetic fields are intended to cause electric induction in the brain cells and, as a consequence, generation of action potentials. The magnetic stimulation is delivered/ generated by a coil, positioned on the patient's scalp, inducing nerve stimulation within the brain. Therefore, when placed over the motor cortex, the magnetic stimulation creates Muscular Evoked potential, which can be measured by EMG.
12001785|NCT00577057|Procedure|Conventional Radiotherapy|
12001786|NCT00577057|Procedure|Accelerated Radiotherapy|
12001792|NCT00577031|Drug|Xeloda|1000mg/m2 po bid on days 1-14 of each 3 week cycle
12001793|NCT00577018|Drug|Prucalopride|4 mg o.d.
12001794|NCT00577018|Drug|Prucalopride|1 mg o.d. for 2 days, 2 mg o.d. for 2 days and 4 mg o.d. thereafter
12001795|NCT00577018|Other|Placebo|o.d.
12001796|NCT00577005|Drug|levetiracetam|The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period.
12001797|NCT00577005|Drug|Placebo|
12001798|NCT00576979|Drug|cyclophosphamide|Given IV
12001799|NCT00576979|Drug|etoposide|Given IV
12001800|NCT00576979|Procedure|allogeneic bone marrow transplantation|Occurs approximately 48 hours after completion of cyclophosphamide
12001801|NCT00576979|Procedure|allogeneic hematopoietic stem cell transplantation|Occurs approximately 48 hours after completion of cyclophosphamide
12001802|NCT00576979|Procedure|peripheral blood stem cell transplantation|Occurs approximately 48 hours after completion of cyclophosphamide
12001803|NCT00576979|Radiation|intensity-modulated radiation therapy|Undergo IMRT
12001804|NCT00576979|Radiation|tomotherapy|Undergo IMRT using helical tomotherapy
12001805|NCT00576940|Drug|Reconvan|isocaloric, immunomodulating entral diet
12001806|NCT00576940|Drug|Peptisorb|isocaloric, isopeptic standard diet
12001807|NCT00576927|Drug|Ramelteon|Subjects demonstrating low sleep efficiencies and prolonged sleep latencies, will be randomly assigned to continue to receive SHI accompanied by either placebo or Ramelteon (8 mg). Matching placebo will be obtained and the medication pre-packaged and ordered based on the randomization results.
12001808|NCT00576927|Drug|Placebo|
12001809|NCT00576914|Drug|recombinant human endostatin|recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
12001810|NCT00576901|Drug|bevacizumab [Avastin]|15mg/kg iv on day 1 of each 3 week cycle
12001811|NCT00576901|Drug|Docetaxel|75mg/m2 iv on day 1 of each 3 week cycle
12001812|NCT00576901|Drug|Xeloda|2000mg/m2 po on days 1-15 of each 3 week cycle
12001813|NCT00576888|Other|no intervention|no intervention - observational only
12001814|NCT00576862|Drug|INSULIN GLARGINE|The subjects will continue the treatment with HOE 901 in the same way as they have done in the previous study. Based on the investigator's assessment and the approved SPC in Belgium/Luxembourg, the dosage can be adjusted individually. HOE 901 is to be injected once daily. HOE 901 must not be mixed with any other insulin, including regular human insulin or fast-acting insulin analogues.
12001815|NCT00576849|Drug|Balanced HES 130/0.42|Volume is administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) was <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg
12001816|NCT00576849|Drug|Balanced HES 130/0.42|Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg
12001817|NCT00576849|Drug|6% HES 130/0.4 prepared in saline solution|Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg
12001818|NCT00576836|Biological|Cultured Thymus Tissue Implantation (CTTI)|Thymus tissue (from unrelated donor), thymus donor, and thymus donor's birth mother screened for safety. CTTI was done under general anesthesia. Cultured thymus tissue was implanted into quadriceps. Thymus dose at least 4grams/m2 body surface area (0.2 grams/kg body weight) and not >18 grams/m2 body surface area (1.0 grams/kg body weight). At time of CTTI, skin biopsy was obtained to look for preexisting T cells. 2-3 months post-CTTI allograft biopsy was done to evaluate for thymopoiesis & graft rejection. At time of biopsy, skin biopsy done to look for T cell clonal populations. (Allograft biopsy not done if subject medically unstable.) Post-CTTI, subjects followed by immune evaluations, using blood samples.
12001819|NCT00576836|Other|Cultured Thymus Tissue Implantation with Parathyroid Transplantation|Parental parathyroid donors screened for eligibility and safety. If both parents meet eligibility criteria, the parathyroid will be harvested from parent who shares the most Human Leukocyte Antigens (HLA) alleles with thymus donor. Parathyroid harvest & transplant preferably done at same time as CTTI. (If parathyroid transplant cannot be done at same time, then it is done within 3-8 weeks of CTTI.) Parathyroid harvest done under general anesthesia. One parathyroid gland is minced & placed in quadriceps muscle; there is no dose in mg. No biopsy done of the parathyroid. Parathyroid donors are monitored as outpatients until recipients' discharge. Recipients' calcium and PTH levels are monitored indefinitely.
12001820|NCT00576823|Drug|Alfuzosin|"Dose: 0.2 mg/kg/day
~Route: oral"
12001821|NCT00576810|Drug|sodium picosulphate|
12001822|NCT00576784|Drug|pioglitazone and glimepiride|switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.
12001823|NCT00576771|Procedure|PSV|Pressure Support Ventilation
12001824|NCT00576771|Procedure|NAVA|Neurally Adjusted Ventilatory Assist
12001825|NCT00576771|Procedure|patient-controlled|assisted controlled MV through a button
12001826|NCT00576758|Drug|obinutuzumab (RO5072759)|1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.
12001827|NCT00576758|Drug|rituximab|375 mg/m^2 rituximab IV infusion once a week for 4 weeks.
12001828|NCT00576745|Procedure|Vicryl Suture|A 4-0 vicryl suture will be used to close the subcuticular layer
12001829|NCT00576745|Device|3M TM S Surgical Skin Closure System|These steri-strips will be applied to close the skin in this cohort of patients
12001830|NCT00576732|Drug|Placebo|Oral solution qd or bid for 6 weeks
12001831|NCT00576732|Drug|Risperidone high dose|Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) qd or bid for 6 weeks
12001832|NCT00576732|Drug|Risperidone low dose|Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) qd or bid for 6 weeks
12001870|NCT00576459|Drug|0.59 mg fluocinolone acetonide intravitreal implant|0.59 mg
12001871|NCT00576459|Drug|2.1 mg fluocinolone acetonide intravitreal implant|2.1 mg
12001833|NCT00576719|Behavioral|Intensive panic control treatment without parent involvement|Intensive panic control treatment without parent involvement is an 8-day, intensive form of cognitive behavioral therapy (CBT) with exposure, including 15-20 hours of direct therapist contact. The basic treatment components are psychoeducation about anxiety, restructuring anxiety-provoking thoughts, exposure to bodily sensations that trigger panic, and in vivo exposures.
12001834|NCT00576719|Behavioral|Intensive panic control treatment with parent involvement|Intensive panic control treatment with parent involvement involves the same form of intensive CBT, but with direct parent involvement. Parents will attend the last 30 minutes of didactic sessions, complete homework assignments, learn ways to coach their children, and participate in selected exposures.
12001835|NCT00576719|Other|Waitlist control|Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.
12001836|NCT00576706|Drug|Rebamipide|Rebamipide 100㎎, 12 weeks
12001837|NCT00576706|Drug|Misoprostol|Misoprostol 200㎍ 12 weeks
12001838|NCT00576693|Device|intracranial angioplasty and stenting|intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).
12001839|NCT00576693|Other|intensive medical management|intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
12001840|NCT00576680|Drug|RAD001|Given orally once a day
12001841|NCT00576680|Drug|Temozolomide|Taken orally once a day for one week followed by a one-week break period
12001842|NCT00576667|Drug|Rimonabant|Tablet, oral administration
12001843|NCT00576667|Drug|Placebo (for Rimonabant)|Tablet, oral administration
12001844|NCT00576654|Drug|Irinotecan Hydrochloride|Given IV
12001845|NCT00576654|Other|Laboratory Biomarker Analysis|Correlative studies
12001846|NCT00576654|Other|Pharmacological Study|Correlative studies
12001847|NCT00576654|Drug|Veliparib|Given PO
12001848|NCT00576641|Biological|autologous dendritic cells|
12001849|NCT00576628|Drug|methoxy polyethylene glycol-epoetin beta [C.E.R.A.]|Recommended starting dose 1.2 micrograms/kg sc monthly
12001850|NCT00576615|Drug|Placebo solution|On the day of the study infusion into the vein of a solution containing no drug, Complete about half a dozen memory tasks over the period of the study, each about 5-10 minutes in length, that involve identification of a list of words, or listen to a list of words/tones before, during, and/or after drug infusion. Allow the recording of your brain waves - the faint electrical activity constantly occurring in your brain- using the electroencephalogram (EEG) while completing memory tasks. Allow the imaging of your brain using functional magnetic resonance imaging (MRI), which measures images of water in your brain in a strong magnetic field, while completing memory tasks.
12001851|NCT00576615|Drug|propofol|"On the study day you will receive study drug propofol. Complete about half a dozen memory tasks over the period of the study, each about 5-10 minutes in length, that involve identification of a list of words, or listen to a list of words/tones before, during, and/or after drug infusion.
~Allow the recording of your brain waves - the faint electrical activity constantly occurring in your brain- using the electroencephalogram (EEG) while completing memory tasks. Allow the imaging of your brain using functional magnetic resonance imaging (MRI), which measures images of water in your brain in a strong magnetic field, while completing memory tasks."
12001852|NCT00576602|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
12001853|NCT00576602|Drug|Supportive treatment|As prescribed
12001854|NCT00576589|Drug|CE-326,597|CE-326,597 administered orally, once daily for 14-days at 1 to 2 doses (25 mg QD, 100 mg QD) with the morning meal.
12001855|NCT00576589|Drug|Placebo|CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
12001856|NCT00576576|Drug|Atorvastatin|Atorvastatin 80 mg a day
12001857|NCT00576563|Drug|FDG|contrast medium
12001858|NCT00576550|Drug|Urea|Urea cream applied twice daily up to six months
12001859|NCT00576550|Drug|betamethasone valerate|Application once daily for two weeks
12001860|NCT00576550|Drug|betamethasone valerate|Application twice daily for two weeks
12001861|NCT00576537|Biological|Dendritic Cell Immunotherapy|Patients will receive four vaccines.
12001862|NCT00576524|Device|ITD|ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
12001863|NCT00576524|Device|Sham|Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
12001864|NCT00576511|Drug|prucalopride|4 mg o.d.
12001865|NCT00576511|Drug|placebo|Placebo o.d.
12001866|NCT00576498|Other|NBI-AFI imaging|"Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source.Target biopsies with standard biopsy forceps will be obtained from the different visualized patterns in separate jars.
~Autofluorescence Imaging- Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm).In this system, normal squamous and non-dysplastic BE appears green while the dysplastic areas appear magenta/purplish. Targeted biopsies will be obtained from the areas with abnormal fluorescence."
12001867|NCT00576498|Other|Standard Endoscopy|Standard Endoscopy- Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars.
12001868|NCT00576485|Procedure|Cataract surgery and intraocular lens implantation|Cataract surgery and implantation of an intraocular lens
12001869|NCT00576472|Drug|Methylphenidate|Please see detailed description for dosing information and study design.
12001872|NCT00576459|Procedure|standard of care laser photocoagulation|standard of care laser photocoagulation
12001873|NCT00576446|Biological|Dendritic cell Vaccine|Patients will receive three vaccines every two weeks
12001874|NCT00576433|Drug|Methotrexate|As prescribed
12001875|NCT00576433|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
12001876|NCT00576420|Biological|FS VH S/D 500 s-apr, 60-seconds polymerization time|FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
12001877|NCT00576420|Biological|FS VH S/D 500 s-apr, 120-seconds polymerization time|Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
12001878|NCT00576420|Procedure|Manual compression with surgical gauze pads|Treatment of the study suture line with manual compression with surgical gauze pads.
12001879|NCT00576407|Biological|Cultured Thymus Tissue for Implantation (CTTI)|Cultured thymus tissue for implantation (CTTI) (previously described as transplantation) is done using allogeneic cultured postnatal tissue from unrelated thymus donors. Thymus tissue, the thymus donor, & thymus donor's birth mother were screened for safety. Approximately 2-3 weeks post-harvest thymus slices were implanted into the recipient's quadriceps. Dose was number of grams of cultured thymus tissue divided by the recipient's weight in kilograms. Minimum dose was 4 g/m2. Maximum dose 18g/m2. At time of CTTI, a skin biopsy was obtained to look for preexisting T cells. 2-3 months post-CTTI allograft biopsy to evaluate for thymopoiesis & graft rejection. At time of biopsy, skin biopsy done to look for T cell clonal populations. Post-CTTI, subjects followed by routine research immune evaluations, using blood samples for approximately 2 years.
12001880|NCT00576394|Drug|IV Insulin drip|IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
12001881|NCT00576394|Drug|Insulin|IV insulin drip to keep serum glucose between 80-120mg/dl.
12001882|NCT00576381|Drug|Dexmedetomidine|Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion
12001883|NCT00576368|Drug|INSULIN GLARGINE|The physician will be guided by the prescribing information outlined in the summary of product characteristics. The administration will be done by once daily subcutaneous injection.
12001884|NCT00576355|Behavioral|Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A)|IPSRT-A involves 20 weeks of individual therapy, incorporating informed psychological, behavioral, and practical strategies adapted to the developmental needs of adolescents.
12001885|NCT00576355|Behavioral|Treatment As Usual (TAU)|TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider.
12001886|NCT00576342|Drug|AL-3862+timolol ophthalmic suspension|
12001887|NCT00576342|Drug|Dorzolamide+timolol ophthalmic solution|
12001888|NCT00576329|Drug|Ketorolac|Topical use before surgery
12001889|NCT00576316|Drug|Symbicort Turbuhaler 160/4.5|
12001890|NCT00576303|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms iv monthly (starting dose)
12001891|NCT00576277|Drug|AV411|
12001892|NCT00576251|Drug|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days
12001893|NCT00576251|Drug|TOBRADEX|TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days
12001894|NCT00576238|Drug|betamethasone valerate|Topical application according to a fixed schedule for three weeks
12001895|NCT00576238|Drug|betamethasone valerate|Topical application according to a fixed schedule for three weeks
12001896|NCT00576238|Drug|urea|Topical application twice daily for up to 6 months
12001897|NCT00576225|Drug|CT-2103/carboplatin|CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
12001898|NCT00576225|Drug|paclitaxel/carboplatin|Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
12001899|NCT00576212|Behavioral|supportive call|Each subject in the intervention group will receive a 10 minute (or longer) biweekly telephone call from a psychologist intended to provide non-judgemental support to TOPFA women with the aim of reducing depression, guilt, isolation, shame, marital discord, and other common psychological sequelae of termination for fetal anomalies.
12001900|NCT00576199|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid in single-use vials.
12001901|NCT00576199|Procedure|Transarterial chemoembolisation (TACE)|"TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization.
~Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE."
12001902|NCT00576173|Drug|tramadol hydrochloride; acetaminophen|
12001903|NCT00576160|Behavioral|PST therapy|Problem-Solving Therapy (PST) is a behavioral approach that teaches patients how to systematically solve their own behavioral difficulties. During telephone treatment sessions, the patient will discuss the problems and difficulties they face and that give rise to medication non-adherence.
12001904|NCT00576147|Device|Infrascanner|The main Near-Infrared spectroscopy (NIRS) head measurement
12001905|NCT00576134|Device|Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing|An artificial Larynx composed of a tracheobronxane ® Dumon ST prosthesis and a valves system will be implant under general anesthesia by endoscopy. The 3 first patients will be patients with tracheotomy, in order to allow breathing through this tracheotomy in case of valves dysfunction.
12001906|NCT00576108|Drug|KD7040 Topical Gel|KD7040 topical gel
12001907|NCT00576108|Drug|Placebo gel|Placebo gel
12001908|NCT00576082|Other|Cutaneous biopsy|Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample
12001909|NCT00576069|Drug|budesonide/formoterol|2 inhalations 2X/daily in treated arm/group. No placebo group
12001910|NCT00576069|Drug|fluticasone/salmeterol|fluticasone 100ug/salmeterol 50ug, 1 inhalation bid noplacebo fluticasone 250ug/salmeterol 50ug, 1 inhalations bid no placebo Spiriva handihaler daily or respihaler 2 inhalations daily no placebo group
12001911|NCT00576069|Drug|mometasone/formoterol|"200/5 mcg two puffs bid 100/5 mcg two puffs bid Breo Ellipta once daily Spiriva capsule handihaler once daily or Spiriva respihaler 2 in
~no placebo group"
12001912|NCT00576069|Drug|Prednisone|0-15 mg daily as needed
12001913|NCT00576056|Drug|Sorafenib|Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
12001914|NCT00576056|Drug|TACE|TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.
12001915|NCT00576043|Procedure|Simulator Training|3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator with the GI-Mentor Virtual simulator device
12001916|NCT00576030|Other|hab cof with water|habitual coffee drinker provided with water
12001917|NCT00576030|Other|hab cof with dec espresso|habitual coffee drinkers given decaffeinated espresso
12001918|NCT00576030|Other|hab cof with caf espresso|habitual coffee drinkers given caffeinated espresso
12001919|NCT00576030|Other|non-hab cof with water|non-habitual coffee drinkers given water
12001920|NCT00576030|Other|non-hab cof with dec espresso|non-habitual coffee drinkers given decaffeinated espresso
12001921|NCT00576030|Other|non-hab cof with caf espresso|non-habitual coffee drinkers given caffeinated espresso
12001922|NCT00576017|Drug|Fentanyl-TTS|
12001923|NCT00576004|Procedure|Pelvic organ prolapse repair and Burch colposuspension|Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
12001924|NCT00575991|Dietary Supplement|Conjugated linoleic acid|3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)
12001925|NCT00575978|Drug|Hydralazine|Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID
12001926|NCT00575965|Drug|Simvastatin|Oral tablets taken daily
12001927|NCT00575952|Drug|Cisplatin|Given IV or IP
12001928|NCT00575952|Drug|Doxorubicin Hydrochloride|Given IV
12001929|NCT00575952|Biological|Filgrastim|Given SC
12001930|NCT00575952|Drug|Paclitaxel|Given IV or IP
12001931|NCT00575952|Biological|Pegfilgrastim|Given SC
12001932|NCT00575926|Drug|LingZhi capsule|LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group
12001933|NCT00575913|Drug|Alfuzosin|Alfuzosin 10 mg One tablet per day after evening meal
12001934|NCT00575900|Behavioral|dietary intervention|12 weeks of dietary intervention
12001935|NCT00575887|Drug|Temozolomide|100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
12001936|NCT00575874|Drug|Rivoglitazone HCl|0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
12001937|NCT00575874|Drug|rivoglitazone HCl|1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
12001938|NCT00575874|Drug|rivoglitazone HCl|1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
12001939|NCT00575874|Drug|pioglitazone HCl|30 mg capsules once daily for 12 weeks
12001940|NCT00575874|Drug|placebo|matching tablets or capsule once daily for 12 weeks
12001941|NCT00575861|Drug|zileuton|zileuton (Zyflo) 600mg qid for 2hr and for 30 days
12001942|NCT00575848|Dietary Supplement|Glycine|Subjects will consume glycine twice daily, once with breakfast and once with dinner. The medication is in liquid form. They will be instructed to refrigerate the liquid until the time that they take it. Subjects start by taking 10g per day for the first 2 days. Starting on the 3rd day, subjects take 0.2g/kg (15g for a 75kg adult) per day, and increase dosage by 0.2g/kg every two days, until they reach 0.8g/kg per day, which they take for the remainder of the 6-week period.
12001943|NCT00575848|Dietary Supplement|Placebo|Subjects will consume placebo twice daily, once with breakfast and once with dinner. The placebo is in liquid form. They will be instructed to refrigerate the liquid until the time that they take it. Subjects start by taking 10g per day for the first 2 days. Starting on the 3rd day, subjects take 0.2g/kg (15g for a 75kg adult) per day, and increase dosage by 0.2g/kg every two days, until they reach 0.8g/kg per day, which they take for the remainder of the 6-week period.
12001944|NCT00575835|Dietary Supplement|vitamin D twice daily|Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year
12001945|NCT00575835|Dietary Supplement|Vitamin D3 oil three times in a year|Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year
12001946|NCT00575822|Device|NDO Full-thickness Plicator|A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.
12001947|NCT00575822|Device|Sham Control|The sham procedure was identical to the treatment procedure through the positioning of the retroflexed Plicator 1cm below the GE junction. The Plicator instrument remained in this position for 15 minutes, based on average procedure times established in previous studies. During the sham procedure, physician investigators were required to talk through the procedure steps to maintain the patient blind.
12001948|NCT00575809|Other|Mucositis and nutritional assessments|Mucositis and nutritional assessments before and during the hematopoietic stem cell transplantation
12001949|NCT00575796|Drug|Vinblastine Sulphate|Vinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week.
12001988|NCT00575419|Drug|N-acetylcysteine|"Dose Level 1: 150 mg/kg/day
~Dose Level 2: 300 mg/kg/day
~Dose Level 3: 600 mg/kg/day
~Dose Level 4: 900 mg/kg/day
~Dose Level 5: 1200 mg/kg/day"
12001950|NCT00575744|Procedure|Sentinel Node Biopsy|Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.
12001951|NCT00575731|Behavioral|Weight management strategies|
12001952|NCT00575718|Behavioral|Hospital Counseling + Nicotine Replacement Therapy. questionaires|"brief face-to-face or telephone tobacco cessation counseling provided by a tobacco cessation specialist prior to admission and during hospitalization (15-20 minutes per encounter)provision of multi-media self-help materials (e.g., Smoking Cessation Guide for Cancer Patients and Their Families) tailored to address cancer-specific issues such as the benefits and barriers of quitting for cancer patients; 3) tobacco cessation pharmacotherapy, unless medically contraindicated (for this study we will standardize the pharmacotherapy as transdermal nicotine patch), and; 4) two brief telephone counseling (15 minutes) sessions completed as seen clinically appropriate by the tobacco cessation specialists. The content of these counseling sessions is based on the patient's smoking status."
12001953|NCT00575718|Behavioral|Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires|Same components of HC+NRT as well as the PS/SRS enhancement.The research team will provide education about scheduled reduced smoking either in person or over the phone. Purpose of the training session, will be audio taped, to prepare participants for daily PDA use over the dur of the scheduled-reduced smoking intervention. Training will demonstrate use of PDA and simulate common technical and procedural issues that might arise during the intervention (e.g., forgetting to record a cigarette or wake time; repeating a day's schedule if needed, prior to the quit date). The simulation will reflect anticipated problems and those identified by users of the PDA. A study helpline number and instructional manual will be provided. A member of the research staff will contact the study participants, once the reduced smoking schedule has begun, to check that the patient understands the schedule and that the PDA is working properly. Estimate patient training with the PDA will require 30 minutes.
12001954|NCT00575679|Behavioral|Brief motivational interview|The brief motivational interview is a non-confrontational, patient-centered discussion between a counselor (e.g., social worker, nurse, physician, or psychologist) and an at-risk individual during which the individual's motivation and confidence to change health-related behaviors are explored.
12001955|NCT00575666|Drug|Insulin or Placebo|intranasal, 40IU, 4 times daily
12001956|NCT00575640|Drug|Hydralazine|Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID
12001957|NCT00575627|Drug|Peg-Interferon alpha2a plus Ribavirin|Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily
12001958|NCT00575614|Drug|prucalopride|1 mg o.d.
12001959|NCT00575614|Drug|placebo|o.d.
12001960|NCT00575601|Drug|SIMVASTATIN|20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used
12001961|NCT00575588|Drug|Metformin|open-label metformin
12001962|NCT00575588|Drug|Sulphonylurea|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
12001963|NCT00575588|Drug|Saxagliptin|Saxagliptin 5 mg tablets
12001964|NCT00575575|Behavioral|cognitive behavior therapy|cognitive behavior therapy once a week
12001965|NCT00575562|Drug|KRN330|Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer
12001966|NCT00575549|Other|Dobutamine: Perflutren Lipid Microsphere|Dobutamine with starting dose of 10 micrograms/kg/min and increased gradually to a maximum dose of 50 micrograms/kg/min Definity will be infused continuously at a rate of 4mL/min
12001967|NCT00575536|Procedure|Rhizotomy for children with spasticity|Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity
12001968|NCT00575523|Drug|Atropine|Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
12001969|NCT00575523|Drug|Placebo|1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
12001970|NCT00575510|Behavioral|Intervention|Multiple component intervention based in the unified theory of behavior
12001971|NCT00575510|Behavioral|Active control|Partial intervention (full intervention minus cultural-specific component)
12001972|NCT00575497|Procedure|More frequent hemodialysis|Six Day per week short daily hemodialysis
12001973|NCT00575497|Procedure|More frequent hemodialysis|Six nights per week nocturnal hemodialysis
12001974|NCT00575497|Procedure|More frequent hemodialysis|Every other day short daily hemodialysis
12001975|NCT00575497|Procedure|More frequent hemodialysis|Every other night hemodialysis
12001976|NCT00575497|Procedure|More frequent hemodialysis|5 days per week short daily hemodialysis
12001977|NCT00575497|Procedure|More frequent hemodialysis|5 nights per week hemodialysis
12001978|NCT00575497|Procedure|Conventional Hemodialysis|3 days per week short daily hemodialysis
12001979|NCT00575484|Drug|Hypertonic saline, then oral sodium chloride|2mL/kg hypertonic saline (4.4% NaCl if serum sodium </=135, else 2.8% NaCl) infused over 30min BID and dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) until patient is switched to oral loop diuretic. After switch to oral diuretic, subject will receive oral 0.75gm sodium (NaCL) capsule dosed BID with loop diuretic (latter dose per treating physician) until 60d after discharge.
12001980|NCT00575484|Drug|Normal saline, then oral placebo capsule|20mL normal saline infusion X 30min BID dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction. After switch to oral diuretic, begin oral placebo capsule BID, dosed with loop diuretic (dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction.
12001981|NCT00575471|Drug|Rivoglitazone HCl|0.5 mg tablets once daily for 12 weeks
12001982|NCT00575471|Drug|rivoglitazone HCl|1.0 mg tablets once daily for 12 weeks
12001983|NCT00575471|Drug|rivoglitazone HCl|1.5 mg tablets once daily for 12 weeks
12001984|NCT00575471|Drug|Placebo|Matching placebo tablets once daily for 12 weeks
12001985|NCT00575432|Radiation|diffusion MRI|diffusion MRI
12001986|NCT00575432|Radiation|BOLD MRI|BOLD MRI
12001987|NCT00575432|Other|Clinical Outcome|Clinical outcome
12001989|NCT00575406|Drug|Rituximab|i.v., 375 mg/m2, d0 or d1 of each treatment cycle
12001990|NCT00575406|Drug|Cyclophosphamide|i.v., 750 mg/m2, d1 of each treatment cycle
12001991|NCT00575406|Drug|Doxorubicin|i.v., 50 mg/m2, d1 of each treatment cycle
12001992|NCT00575406|Drug|liposomal Doxorubicin|i.v., 50 mg/m2, d1 of each treatment cycle
12001993|NCT00575406|Drug|Vincristin|i.v., 2mg, d1 of each treatment cycle
12001994|NCT00575406|Drug|Prednisolone|p.o., 100mg, d1 - d5 of each treatment cycle
12001995|NCT00575393|Drug|gold sodium thiomalate|
12001996|NCT00575393|Genetic|gene expression analysis|
12001997|NCT00575393|Other|fluorine F 18 fluorothymidine|
12001998|NCT00575393|Other|mass spectrometry|
12001999|NCT00575393|Other|pharmacological study|
12002000|NCT00575380|Drug|AzaSite Eye Drops|One drop two times a day for two days and once a day for the next five days.
12002001|NCT00575380|Drug|Vigamox Eye Drops|One drop three times a day for seven days
12002002|NCT00575367|Drug|AzaSite (azithromycin ophthalmic solution)|One drop ophthalmic solution at Visit 2
12002003|NCT00575367|Drug|Vigamox (moxifloxacin hydrochloride ophthalmic solution)|One drop ophthalmic solution at Visit 2
12002004|NCT00575354|Drug|Sevoflurane|3-6% sevoflurane inhaled for anesthesia induction, and 2-3% sevoflurane was used to maintain the anesthesia till the end of the operation.
12002005|NCT00575354|Drug|Isoflurane|3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.
12002006|NCT00575341|Drug|Dehydroepiandrosterone|25 mg DHEA, oral, once daily
12002007|NCT00575341|Drug|placebo|placebo, oral, once daily
12002008|NCT00575328|Drug|Maca Root|3g/day of Maca Root for 12 weeks.
12002009|NCT00575328|Drug|Placebo|Placebo provided by research pharmacy daily for 12 weeks.
12002010|NCT00575302|Drug|Gonal-f®: follitropin alpha|Gonal-f®: follitropin alpha, administration of 300 U
12002011|NCT00575302|Drug|Gonal-f®: follitropin alpha|Gonal-f®: follitropin alpha, administration of 450 U
12002012|NCT00575250|Behavioral|Osteoporosis Prevention and Self-Management Course|Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.
12002013|NCT00575250|Behavioral|Introductory education session on osteoporosis|Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.
12002014|NCT00575237|Procedure|Recruitment manouver|In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers.
12002015|NCT00575224|Drug|Pegylated interferon and ribavirin|180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.
12002016|NCT00575198|Other|No drainage threshold|Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
12002017|NCT00575198|Other|Drainage <2 mL/kg|Removal of the thoracostomy tube only if the drainage from the tube in the prior 24 hours is less than 2 mL/kg of the patient's ideal body weight
12002018|NCT00575185|Drug|Valomaciclovir|4 grams orally of valomaciclovir (2 grams BID) for 21 days.
12002019|NCT00575185|Drug|placebo|Placebo tablets orally twice daily for 21 days.
12002020|NCT00575159|Drug|GSK189075|investigational drug
12002021|NCT00575159|Drug|placebo|placebo comparator
12002022|NCT00575146|Dietary Supplement|TAVARLIN|ketogenic diet, dietary supplementary products provided by TAVARLIN
12002023|NCT00575120|Other|ischemia reperfusion|reperfusion after a 15 min. lasting cuff induced arm ischemia
12002024|NCT00575107|Other|Exercise|Velocity-controlled variable resistance protocols enable trainees to load their muscles more optimally along the entire ROM in either or both of the shortening (VSC) and lengthening (VLC) phases of a training repetition
12002025|NCT00575107|Other|Exercise|Standard training of leg extension
12002026|NCT00575094|Drug|tigecycline|Dosage form: Tigecycline 50 mg for injection (Lyophilized powder in 5 mL vial) Dosage frequency: Tigecycline 100 mg loading followed by 50 mg every 12 hrs (bid) Duration of therapy: 7 to 14 days
12002027|NCT00575081|Device|Stereotactic brain procedures|Stereotactic brain procedures
12002028|NCT00575068|Drug|IDEC-114|Phase 1-A Group 1 - 125 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 2 - 250 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 3 - 375 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-B Group 4 - 500 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase II-A & II-B - Dosage start at the MTD (up to 375 mg/m2)
12002029|NCT00575055|Drug|Bapineuzumab 0.5 mg/kg|given by infusion every 13 weeks for a total of 6 infusions.
12002030|NCT00575055|Drug|Placebo Control|given by infusion every 13 weeks for a total of 6 infusions.
12002031|NCT00575055|Drug|Bapineuzumab 1.0 m/kg|given by infusion every 13 weeks for a total of 6 infusions.
12002032|NCT00575042|Drug|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)|160 mg per day for 1 year
12002033|NCT00575029|Drug|megestrol acetate|600 mg by mouth daily
12002034|NCT00575016|Biological|Normal saline (Placebo); botulinum toxin Type A (200U)|Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
12002035|NCT00575016|Biological|botulinum toxin Type A (50U); botulinum toxin Type A (200U)|botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
12002036|NCT00575016|Biological|botulinum toxin Type A (100U); botulinum toxin Type A (200U)|botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
12002037|NCT00575016|Biological|botulinum toxin Type A (200U)|botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
12002038|NCT00575003|Drug|CYT003-QbG10|6 subcutaneous injections
12002039|NCT00574977|Biological|Vaccinia virus (vvDD-CDSR)|"Eligible subjects will receive 1 treatment of vvDD-CDSR. A dose can be divided between 1-3 lesions. The sum total of the maximal diameters of the lesion(s) to be injected must be < 10cm.
~Cohort 1: 3 x 10e7 p.f.u. Cohort 2: 1 x 10e8 p.f.u. Cohort 3: 3 x 10e8 p.f.u. Cohort 4: 1 x 10e9 p.f.u. Cohort 5: 3 x 10e9 p.f.u."
12002075|NCT00574691|Device|7F Ensure Medical Vascular Closure Device|Vascular Closure Device
12002132|NCT00574379|Drug|Placebo|Placebo tablets twice daily for 14 days
12002040|NCT00574977|Biological|Vaccinia virus (vvDD-CDSR)|"Eligible subjects will receive 1 treatment of vvDD-CDSR. A dose can be divided between 1-3 lesions. The sum total of the maximal diameters of the lesion(s) to be injected must be < 10cm.
~Cohort 1: 3 x 10e7 p.f.u. Cohort 2: 1 x 10e8 p.f.u. Cohort 3: 3 x 10e8 p.f.u. Cohort 4: 1 x 10e9 p.f.u. Cohort 5: 3 x 10e9 p.f.u."
12002041|NCT00574977|Biological|Vaccinia virus (vvDD-CDSR)|"Eligible subjects will receive 1 infusion of vvDD-CDSR.
~Cohort 1: 3 x 10e8 p.f.u; Cohort 2: 1 x 10e9 p.f.u.; Cohort 3: 3 x 10e9 p.f.u."
12002042|NCT00574964|Other|Gliadel Wafer, Temodar and Radiotherapy|Given concurrently starting 10-30 days after surgery.
12002043|NCT00574951|Drug|motesanib diphosphate|
12002044|NCT00574925|Drug|Esomeprazole|
12002045|NCT00574912|Drug|Placebo|single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours
12002046|NCT00574912|Drug|Insulin Glargine 0.5 u/kg body wt SC|8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)
12002047|NCT00574912|Drug|Insulin Glargine 1.0 u/kg body wt SC|
12002048|NCT00574912|Drug|Insulin Glargine 1.5 u/kg body wt SC|
12002049|NCT00574912|Drug|Insulin Glargine 2.0 u/kg body wt SC|
12002050|NCT00574899|Other|Questioners, blood specimens, prostate tissue specimens|"You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
~Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat."
12002051|NCT00574899|Other|Questioners, blood specimens, prostate tissue specimens|"You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
~Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat."
12002052|NCT00574886|Biological|Id-KLH|Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.
12002053|NCT00574873|Drug|Bosutinib|500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
12002054|NCT00574873|Drug|imatinib|400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
12002055|NCT00574860|Drug|EN3285|Oral rinse
12002056|NCT00574860|Drug|Placebo|Oral rinse
12002057|NCT00574860|Other|Standard of care|This will be the therapy most commonly used the the institution treating the patient
12002058|NCT00574847|Drug|Escitalopram|Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
12002059|NCT00574847|Drug|Placebo|Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
12002060|NCT00574834|Drug|Ramipril|Ramipril 20 mg once daily for 6 months
12002061|NCT00574834|Drug|HCTZ-hydrochlorothiazide|HCTZ 25 mg once daily for 6 months
12002062|NCT00574834|Drug|Ramipril+HCTZ|Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months
12002063|NCT00574808|Other|Outreach Facilitation implementing elements of the Chronic Care Model|"An outreach facilitator helps the practice identify areas for improvement, set goals and targets, and agree on the processes needed to reach them in order to improve the care delivery within the practices. Each facilitator will be assigned up to 12 practice sites. The first year of program implementation will involve frequent (once every 3-4 weeks) visits to the practices. Afterwards, the intervention will move into a sustainability mode, during which the frequency of visits will decrease to one every 6-8 weeks during the second year, and one every 12-15 weeks during the third year and thereafter. After the first year of program implementation, each facilitator will be able to take on 12 new practices during the second year, while still being able to sustain contact with the previous 12 practices. Similarly, in the third year, another set of 12 practices will begin the intense phase of program implementation."
12002064|NCT00574795|Biological|13vPnC|"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"
12002065|NCT00574769|Drug|RAD001, Docetaxel, Bevacizumab|"RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily
~Bevacizumab infusion (IV), 15 mg/kg every 21 days
~Docetaxel infusion (IV), 75 mg/m^2 every 21 days"
12002066|NCT00574756|Drug|ranolazine|extended release 500 mg twice a day for two weeks
12002067|NCT00574743|Drug|Enteric-coated Mycophenolate Sodium|
12002068|NCT00574730|Drug|CHOP/Rituximab|"Six cycles of CHOP/Rituximab therapy at 21-day intervals. CHOP chemo will be administered on day 1 after rituximab.
~Cyclophosphamide750mg/m2 IV, Doxorubicin 50mg/m2 IV, Vincristine 1.4mg/m2 (max 2mg) IV, Prednisone 100mg PO daily x 5 days Rituximab 375mg/m2"
12002069|NCT00574730|Drug|PEG INTRON|Pegylated Interferon-alpha 2mg/kg/week for 52 weeks
12002070|NCT00574717|Procedure|Spectacles|Infants will receive spectacles with 3.00D of under-correction relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. They will also receive the full amount of measured astigmatism in their glasses. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D of the target 3.00D. A program of visual engagement is also provided to encourage the normal development and use of accommodation. Treatment will continue for 15 months (until 18 months of age) or until the infant reaches a spherical equivalent refractive error of +3.00D or less hyperopia.
12002071|NCT00574704|Drug|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)|subcutaneous injections at 6 visits
12002072|NCT00574704|Drug|House dust mite allergen extract in combination with CYT003-QbG10-placebo|subcutaneous injections at 6 visits
12002073|NCT00574704|Drug|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo|subcutaneous injections at 6 visits
12002074|NCT00574704|Drug|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo|subcutaneous injections at 6 visits
12002076|NCT00574678|Other|Tear collection|"A tear sample (~75 microliters in a tuberculin syringe with the needle removed) will be taken at time of the initial clinic visit. After collection, the tears will be put directly on ice and taken to the lab. If it is not possible to obtain natural tears, an eye wash method using sterile saline will be employed and the fluid collected using the aforementioned technique. The SELDI-MS process will be conducted on the specimen immediately. The remainder of the tear specimen will be stored in a -80ºC freezer until completely analyzed."
12002077|NCT00574665|Other|Hyperinsulinemic Hyperglycemic Clamp|Glucose Clamp
12002078|NCT00574652|Drug|Proleukin|3 millions IU/day from day 1 to 5 every 21 days will be carried out at W1, W3, W6, and W9)
12002079|NCT00574639|Drug|Alprazolam|1 mg given orally prior to morning and afternoon clamps on Day 1
12002080|NCT00574639|Drug|Placebo|1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)
12002081|NCT00574626|Procedure|PBSCT|Peripheral Blood Stem Cell Transplant
12002082|NCT00574626|Procedure|Bone Marrow Transplant|Bone Marrow Transplant
12002083|NCT00574613|Drug|P144|Cream 0,3 ml once a day (3 months)
12002084|NCT00574613|Drug|placebo|Cream 0,3 ml once a day (3 months)
12002085|NCT00574600|Biological|SAAVI DNA-C2 vaccine|DNA vaccine
12002086|NCT00574600|Biological|SAAVI MVA-C vaccine|Boost vaccine
12002087|NCT00574600|Biological|Placebo|Placebo vaccine
12002088|NCT00574587|Drug|Vorinostat|Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose
12002089|NCT00574587|Drug|Paclitaxel|Paclitaxel 80 mg/m2 weekly for 12 weeks
12002090|NCT00574587|Drug|Trastuzumab|Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose
12002091|NCT00574587|Drug|Doxorubicin|Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks
12002092|NCT00574587|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks
12002093|NCT00574587|Procedure|Surgery|Surgical excision of tumor from breast
12002094|NCT00574574|Dietary Supplement|anthocyanin|500mg/d of anthocyanin each day for 12 weeks (84days). Route of administration: oral capsules, 4 X 250mg capsules (125mg anthocyanin/ capsule). Dosage advice; 2 capsules to be taken with food, twice per day (n=4 in total).
12002095|NCT00574548|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
12002096|NCT00574548|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
12002097|NCT00574548|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
12002098|NCT00574548|Biological|23-valent Pneumococcal Polysaccharide Vaccine|0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
12002099|NCT00574548|Biological|23-valent Pneumococcal Polysaccharide Vaccine|0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
12002100|NCT00574522|Radiation|Far infrared|Far infrared radiation with the wavelength between 5μm and 20μm for 30 to 40 minutes per session.
12002101|NCT00574509|Radiation|131Iodine-Anti-B1 Radioimmunotherapy|Dosimetric dose of 450 mg unlabeled Anti-B1 followed by 35 mg Anti-B1 which has been trace labeled with 5mCi of 131I-Anti-B1.
12002102|NCT00574496|Drug|cyclophosphamide|
12002103|NCT00574496|Drug|cyclosporine|
12002104|NCT00574496|Drug|fludarabine phosphate|
12002105|NCT00574496|Drug|gemcitabine hydrochloride|
12002106|NCT00574496|Drug|ifosfamide|
12002107|NCT00574496|Drug|mechlorethamine hydrochloride|
12002108|NCT00574496|Drug|melphalan|
12002109|NCT00574496|Drug|methotrexate|
12002110|NCT00574496|Drug|mycophenolate mofetil|
12002111|NCT00574496|Drug|prednisone|
12002112|NCT00574496|Drug|procarbazine hydrochloride|
12002113|NCT00574496|Drug|vincristine sulfate|
12002114|NCT00574496|Drug|vinorelbine tartrate|
12002115|NCT00574496|Procedure|allogeneic bone marrow transplantation|
12002116|NCT00574496|Procedure|allogeneic hematopoietic stem cell transplantation|
12002117|NCT00574496|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
12002118|NCT00574496|Procedure|peripheral blood stem cell transplantation|
12002119|NCT00574496|Procedure|umbilical cord blood transplantation|
12002120|NCT00574496|Radiation|total-body irradiation|
12002121|NCT00574483|Drug|quinacrine|100 mg day
12002122|NCT00574470|Drug|daclizumab, infliximab|Daclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22.
12002123|NCT00574457|Other|Carotid Ultrasound|All subjects that meet the inclusion criteria at each certified site will be invited to participate and go through the same intervention (questionaire-scan-post scan questionaire and 1 month follow up questionaire)
12002124|NCT00574444|Procedure|transvaginal diagnostic peritoneoscopy|For patients with pelvic pain, a transvaginal procedure can be done to explore the abdomen. Entering through the vagina, will hopefully decrease the number of ports in the abdomen and decrease pain and healing time.
12002125|NCT00574431|Other|Data Collection|Collection of patient data before implementation of a nutritional management protocol
12002126|NCT00574431|Other|Nutritional management protocol|Collection of patient data after implementation of a nutritional management protocol
12002127|NCT00574418|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.
12002128|NCT00574405|Drug|MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])|MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
12002129|NCT00574405|Device|CSII (Animas Corporation insulin pump, model IR 1200)|CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
12002130|NCT00574392|Device|Multiwavelength and coherence confocal reflectance microscopy (Vivascope 1500m multiwavelength)|Patients will be imaged with the Vivascope 1500m multiwavelength coherence microscope during a single patient visit. The lesion will be photographed with high resolution photography and surface epiluminescence microscopy. The clinically uninvolved site will be imaged in the same manner.
12002131|NCT00574379|Drug|Bilastine|Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
12002133|NCT00574366|Drug|erlotinib|"Levels:
~1 Erlotinib 50 mg/d
~2 Erlotinib 50 mg/d
~1 Erlotinib 100 mg/d
~2 Erlotinib 100 mg/d
~3 Erlotinib 150 mg/d
~4 Erlotinib 150 mg/d"
12002134|NCT00574366|Drug|RAD001|"Levels
~minus 1: RAD001 2.5 mg/d
~minus 2: RAD001 2.5 every other day
~RAD001 2.5 mg per day
~RAD001 5 mg per day
~RAD001 10 mg per day
~RAD001 10 mg per day"
12002135|NCT00574353|Radiation|Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission|You will be scanned 2 to 3 times on the same day, but you will only be administered one dose of the FMISO tracer. The first scan will last about 30 minutes. Then you will have 1 to 3 hours to wait before you are scanned again. Some patients will undergo a second scan approximately one-and-a-half hours after the start of the first scan. This scan will last about 10 minutes. The final scan will occur between 2-4 hours after the start of the first scan. This final scan will also last about 10 minutes. During the PET scan, you may have a separate i.v. line put into your other arm so that we can take 2 to 3 blood samples. These samples will be less than half a teaspoon each. We are taking these blood samples to see how quickly FMISO leaves your blood stream. The first sample will be taken between 2 and 40 minutes after the FMISO is injected. The other two blood samples will be taken with each subsequent scan.
12002136|NCT00574340|Other|Hyperinsulinemic Hypoglycemic Clamp|all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks
12002137|NCT00574314|Other|No Intervention|Participants will be consented.
12002138|NCT00574301|Procedure|Percutaneous Removal and Margin Ablation|Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.
12002139|NCT00574288|Drug|Part 1: Daratumumab|First participant will receive intravenous (injection of a substance into a vein) 0.005 milligram per kilogram (mg/kg) (planned dose) infusion of daratumumab and other participants will receive different doses. The participants will receive 7 full infusions of daratumumab and 2 predose infusions every 2 weeks. The dose of daratumumab will be escalated sequentially and considering the safety and efficacy of dose in Part 1, dose for Part 2 of the study will be decided. A predose infusion of 10% of the full dose of daratumumab will be administered a day before the first 2 full infusions.
12002140|NCT00574288|Drug|Part 2: Daratumumab|In Part 2, the participants will receive dose of daratumumab as determined in part 1 (16 mg/kg) of the study. Participants will receive 8 full infusions at weekly intervals followed by biweekly (every 2 weeks) infusions for 16 additional weeks and monthly infusions until disease progression or unmanageable toxicity, whichever comes first. Predose was dropped at some point in Part 2. A predose infusion of 10 mg daratumumab will be administered on the day before the first full infusion in select cohorts.
12002141|NCT00574288|Other|Methylprednisolone|"Pre-dose: Participants (part 1) will receive methylprednisolone 80 mg intravenous (IV) injection 30 minutes to 2 hours before treatment. Participants (part 2) will receive 100 mg methylprednisolone IV 60 minutes to 2 hours before treatment; if a patient experiences no significant infusion-related reactions, the dose of methylprednisolone may be decreased to 50 mg after Visit 4.
~Post-dose: All participants (part 1) will receive 40 mg methylprednisolone orally on the first and the second day after all full infusions. During Part 2, all participants will receive 20-25 mg methylprednisolone orally or equivalent on the first and second days after all full-dose infusions."
12002142|NCT00574288|Other|Dexamethasone|Participants (Part 2) will receive 20 mg dexamethasone intravenous (IV) injection pre-dose, on the first and second days after every full-dose infusions.
12002143|NCT00574275|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
12002144|NCT00574275|Drug|Placebo|4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle
12002145|NCT00574275|Drug|Gemcitabine|1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.
12002146|NCT00574249|Biological|adalimumab|subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15
12002147|NCT00574249|Drug|Calcipotriol/Betamethasone Ointment|Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
12002148|NCT00574249|Drug|placebo (vehicle ointment)|Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
12002149|NCT00574236|Drug|PS-341, doxorubicin|bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle
12002150|NCT00574223|Drug|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)|subcutaneous injections at 8 visits
12002151|NCT00574223|Drug|House dust mite allergen extract in combination with CYT003-QbG10-placebo|subcutaneous injections at 8 visits
12002152|NCT00574210|Drug|Bilastine|Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
12002153|NCT00574210|Drug|Placebo|Placebo Tablets administered twice per day
12002154|NCT00574197|Drug|Mycophenolate Sodium|1440mg/day (720mg by mouth, twice a day)
12002155|NCT00574171|Drug|lapatinib|1250mg by mouth daily one hour before or after breakfast on a continuous basis.
12002156|NCT00574171|Drug|Capecitabine|2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
12002157|NCT00574145|Procedure|Bio-field energy therapy|Practitioner's hands to influence the human energy field surrounding the patient's body.
12002158|NCT00574145|Procedure|fatigue assessment and management|duration
12002159|NCT00574145|Procedure|psychosocial assessment and care|duration
12002160|NCT00574145|Procedure|quality-of-life assessment|duration
12002161|NCT00574145|Procedure|therapeutic touch|Practitioner's hands to influence the human energy field surrounding the patient's body
12002217|NCT00573833|Radiation|brachytherapy|
12002162|NCT00574132|Drug|Bapineuzumab 0.5 mg/kg|infusion every 13 weeks for a total of 6 infusions
12002163|NCT00574132|Drug|Placebo Control|given by infusion every 13 weeks for a total of 6 infusions.
12002164|NCT00574132|Drug|Bapineuzumab 1.0 m/kg|infusion every 13 weeks for a total of 6 infusions
12002165|NCT00574119|Drug|spironolactone|spironolactone 50 mg daily for 6 months
12002166|NCT00574106|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength)
12002167|NCT00574093|Drug|Ranibizumab; Verteporfin|Patients will be administered Lucentis™ 0.5 mg on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.
12002168|NCT00574080|Drug|Interim/Maintenance Dexamethasone|20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
12002169|NCT00574080|Drug|Induction/Consolidation Dexamethasone|40 mg Days 1-4
12002170|NCT00574080|Drug|Induction/Consolidation Cisplatin|10 mg/m2 by continuous infusion Days 1-4
12002171|NCT00574080|Drug|Induction/Consolidation Adriamycin|10 mg/m2 by continuous infusion Days 1-4
12002172|NCT00574080|Drug|InductionConsolidation Cyclophosphamide|400 mg/m2 by continuous infusion Days 1-4
12002173|NCT00574080|Drug|Induction/Consolidation Etoposide|40 mg/m2 by continuous infusion Days 1-4
12002174|NCT00574080|Drug|Induction Pegfilgrastim|6 mg Days 6 and 13
12002175|NCT00574080|Drug|Transplant 1 Dexamethasone|20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
12002176|NCT00574080|Drug|Transplant 1 Cisplatin|20 mg/m2 by continuous infusion Days -3 and -2
12002177|NCT00574080|Drug|Transplant 1 Adriamycin|20 mg/m2 by continuous infusion Days -3 and -2
12002178|NCT00574080|Drug|Transplant 1 Cyclophosphamide|800 mg/m2 by continuous infusion Days -3 and -2
12002179|NCT00574080|Drug|Transplant 1 Etoposide|80 mg/m2 by continuous infusion Days -3 and -2
12002180|NCT00574080|Drug|Transplant 1 Melphalan|50 mg/m2 Days -2 and -1
12002181|NCT00574080|Drug|Transplant 1 and 2 Pegfilgrastim|6 mg Day +6
12002182|NCT00574080|Procedure|Autologous Peripheral Blood Stem Cell Transplant (ASCT)|Day 0
12002183|NCT00574080|Drug|Transplant 2 Carmustine|300 mg/m2 Day -5
12002184|NCT00574080|Drug|Transplant 2 Etoposide|200 mg/m2 Days -5, -4, -3, -2
12002185|NCT00574080|Drug|Transplant 2 Cytarabine|400 mg/m2 Days -5, -4, -3, -2
12002186|NCT00574080|Drug|Transplant 2 Melphalan|140 mg/m2 Day -1
12002187|NCT00574080|Drug|Transplant 2 Dexamethasone|20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
12002188|NCT00574080|Drug|Transplant 1 and 2 Bortezomib|1 mg/m2 Days -4, -1, +3, +7
12002189|NCT00574080|Drug|Transplant 1 and 2 Thalidomide|200 mg Days -4 to +5
12002190|NCT00574067|Drug|Buprenorphine +OTP|Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment (OTP) program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
12002191|NCT00574067|Drug|Buprenorphine +CHC|Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center (CHC). Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
12002192|NCT00574067|Drug|Counseling +OTP|Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
12002193|NCT00574067|Drug|Counseling +CHC|Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
12002194|NCT00574054|Radiation|Far Infrared|Far infrared radiation (5 μm to 20 μm wavelength) for 30 to 40 minutes per treatment session.
12002195|NCT00574041|Drug|Interferon beta-1a|injected, once a week
12002196|NCT00574015|Drug|hydrocodone/acetaminophen|oral hydrocodone 10 mg/acetaminophen 650 mg
12002197|NCT00574015|Drug|bupivacaine (supraperiosteal nerve block)|Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root
12002198|NCT00573989|Drug|erlotinib hydrochloride|
12002199|NCT00573989|Drug|pemetrexed disodium|
12002200|NCT00573989|Procedure|quality-of-life assessment|
12002201|NCT00573989|Radiation|intensity-modulated radiation therapy|
12002202|NCT00573963|Drug|ropivacaine|2 injections of 20mL 0.375% ropivacaine - one given on each side.
12002203|NCT00573963|Drug|saline solution|2 injections of 20mL plain saline solution - one on each side.
12002204|NCT00573950|Drug|cilostazol|50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
12002205|NCT00573950|Drug|Placebo|Placebo tablet comparable to 50mg cilostazol two times a day for 2 weeks and then placebo tablet comparable to 100mg cilostazol two times a day for 6 weeks
12002206|NCT00573937|Drug|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
12002207|NCT00573937|Drug|Morphine|Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.
12002208|NCT00573924|Drug|Proton pump inhibitor (lansoprazole)|"120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs
~90 mg IV bolus followed 9 mg/hr infusion for 24 hrs"
12002209|NCT00573911|Procedure|Endoscopy and pH study|endoscopy and PH study done one time
12002210|NCT00573885|Drug|defined green tea catechin extract|Given orally
12002211|NCT00573885|Other|placebo|Given orally
12002212|NCT00573872|Radiation|Radiosurgery|"Phase I: 20-25 Gy in 5 fractions
~Phase II: 9-24 GY in 1 fraction"
12002213|NCT00573859|Drug|ADHD medication|For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.
12002214|NCT00573859|Drug|Placebo|For the placebo condition, participants received placebo pills for two consecutive days.
12002215|NCT00573833|Other|questionnaire administration|
12002216|NCT00573833|Procedure|quality-of-life assessment|
12002218|NCT00573820|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each treatment session.
12002219|NCT00573807|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation (5μm to 20μm wavelength)for 30 to 40 minutes per treatment session.
12002220|NCT00573794|Biological|adalimumab|adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
12002221|NCT00573781|Dietary Supplement|Diet with increased intake of rye bread, berries and fish|Dietary modification with commercial food items
12002222|NCT00573781|Dietary Supplement|Increased intake of whole grain and rye bread|Dietary modification with commercial food items
12002223|NCT00573781|Dietary Supplement|Control diet with decreased intake of rye bread, berries and fish|Dietary modification with commercial food items
12002224|NCT00573768|Drug|Diclofenac diethylamine 2.32% gel|Diclofenac diethylamine 2.32% gel twice daily
12002225|NCT00573768|Drug|Placebo|Vehicle 2 times daily
12002226|NCT00573768|Drug|Diclofenac diethylamine 2.32% gel / Placebo|Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
12002227|NCT00573755|Drug|anastrozole|given orally
12002228|NCT00573755|Drug|exemestane|given orally
12002229|NCT00573755|Drug|letrozole|given orally
12002230|NCT00573755|Drug|sorafenib tosylate|given orally
12002231|NCT00573755|Other|placebo|given orally
12002232|NCT00573742|Drug|Candesartan Cilexeotil 16mg|
12002233|NCT00573729|Other|Pulsed Dye Laser 577 nm|Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
12002234|NCT00573729|Other|Pulsed Dye Laser 595 nm|Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
12002235|NCT00573703|Procedure|Laparoscopic Burch colposuspension|Lapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique.
12002236|NCT00573703|Procedure|Transobturator tape procedure|Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period.
12002237|NCT00573690|Drug|carboplatin|Given IV
12002238|NCT00573690|Drug|cisplatin|Given IV
12002239|NCT00573690|Drug|etoposide|Given IV
12002240|NCT00573690|Drug|pemetrexed disodium|Given IV
12002241|NCT00573690|Drug|sorafenib tosylate|Given orally
12002242|NCT00573664|Drug|Gabapentin|single oral dose of 600mg gabapentin
12002243|NCT00573664|Other|lactose|Single dose
12002244|NCT00573651|Other|Blood Draws for Serum Titers|All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.
12002245|NCT00573638|Device|Xal-Ease device to be used with Xalatan eye drops|This intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop.
12002246|NCT00573612|Behavioral|Attention Control Counseling|Subjects will receive educational-based telephone counseling regarding fibromyalgia.
12002247|NCT00573612|Behavioral|Motivational Interviewing|Subjects will receive Motivational Interviewing telephone counseling.
12002248|NCT00573599|Drug|prochlorperazine and benadryl IV|prochlorperazine and benadryl IV, saline subQ
12002249|NCT00573599|Drug|Imitrex SubQ, saline IV|Imitrex SubQ, saline IV
12002250|NCT00573586|Device|Sonablate 500 (SB-500)|Sonablate 500 (SB-500)
12002251|NCT00573573|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.
12002252|NCT00573560|Device|VPD Implant System|Percutaneous introduction using standard catheterization techniques of the VPD Implant.
12002253|NCT00573547|Drug|Fluoxetine|Fluoxetine will be dosed at 90 mg once a week
12002254|NCT00573534|Drug|Vyvanse|Patients will be titrated from 30 mgs to 50 mgs to 70 mgs over four weeks, as tolerated and as needed to control ADHD symptoms
12002255|NCT00573508|Drug|Placebo|Oral Administration
12002256|NCT00573508|Drug|Solifenacin Succinate|Oral Administration
12002257|NCT00573495|Biological|hTERT/Survivin Multi-Peptide Vaccine|100 mcg subcutaneous every 2 weeks four times, then monthly up to 28 vaccinations
12002258|NCT00573482|Behavioral|REDE|"The intervention group received the education in REDE techniques.
~The intervention in this study comprised four components:
~Four group education sessions to introduce the REDE principles of eating;
~Approximately 10 new lower energy-dense foods were introduced in the employee cafeteria daily at lunchtime;
~Food labels for all foods sold in the employee cafeteria at lunch time, which provided the energy density, calories, and macronutrient content of the prepared cafeteria foods. Prior to the intervention almost no foods had food labels.
~Price reductions for lower energy density items. Both groups were exposed to the food labels and the new lower ED foods, but only the intervention group received the education sessions about how to take advantage of the new labels and cafeteria foods and only they were eligible for the price reductions."
12002259|NCT00573482|Behavioral|control|The control group received no REDE intervention at all. Both groups were exposed to the food labels and the new lower ED foods, but the control group did not receive the education sessions.
12002260|NCT00573469|Drug|D9421-C, 9mg|D9421-C 9 mg was given once daily for 8 weeks.
12002261|NCT00573469|Drug|D9421-C, 15mg|D9421-C 15 mg was given once daily for 8 weeks.
12002262|NCT00573469|Drug|Placebo|D9421-C matching placebo was given once daily for 8 weeks.
12002263|NCT00573456|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes per session.
12002264|NCT00573443|Drug|dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg|Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 20 mg/ Q 10 mg, taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
12002309|NCT00573131|Drug|cisplatin|75 mg/m2 IV (in the vein) once on Day 1 and Day 29
12003149|NCT00566917|Procedure|Anterior PROLIFT|Transvaginal mesh surgery of the anterior vaginal wall
12002265|NCT00573443|Drug|dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg|Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 30 mg/ Q 10 mg taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
12002266|NCT00573443|Drug|Placebo|Placebo capsules (identical in appearance to AVP-923 capsules being studied in this trial), taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
12002267|NCT00573430|Drug|Candesartan Cilexetil|8 mg oral once daily dose
12002268|NCT00573430|Drug|Candesartan Cilexetil|16 mg oral once daily dose
12002269|NCT00573430|Drug|Candesartan Cilexetil 32mg|32 mg oral once daily dose
12002270|NCT00573417|Drug|modafinil|modafinil 100mg tablets. dose excalation up to 300mg
12002271|NCT00573417|Drug|Placebo|
12002272|NCT00573404|Drug|imatinib mesylate|will start at 200 mg daily and will be escalated up to 400 mg bid.If the 400 mg bid dose is tolerated, no further dose escalation will be performed. In the case of excessive toxicity on the starting dose, the option for de-escalation is provided. Sunitinib will start at 25 mg daily and if tolerated, will be escalated to 37.5 mg daily for subsequent dose levels.
12002273|NCT00573404|Drug|sunitinib malate|
12002274|NCT00573404|Other|pharmacological study|
12002275|NCT00573391|Drug|Velcade, Thalidomide, and Dexamethasone|"Velcade - Into vein (IV) Days 1, 4, 8, 11
~Yr 1: Every 28-35 days-12 cycles
~Yr 2: Every 8-10 weeks- 6 cycles
~Thalidomide - By Mouth Days 1-28
~Yr 1: Every 28-35 days-12 cycles
~Yr 2: Every 8-10 weeks- 6 cycles"
12002276|NCT00573391|Drug|Velcade, Melphalan, and Dexamethasone|"Velcade - Into vein (IV) Days 1, 4, 8, 11
~Yr 1: Every 28-35 days-12 cycles
~Yr 2: Every 8-10 weeks- 6 cycles"
12002277|NCT00573378|Drug|PEG-IFN-a2b|Patients will receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week. Patients and/or caregivers identified by the patient will be taught how to perform subcutaneous injections of the PEG-IFN-α2b by trained nurses in the chemotherapy infusion center at the University of Michigan Comprehensive Cancer Center. Those patients who do not feel comfortable receiving the injections outside of the cancer center, or are deemed unreliable in administering injections per the training nurse, will return to the cancer center infusion room on a weekly basis to receive subsequent injections.
12002278|NCT00573365|Device|Gentlewaves Select™ handheld high energy LED array|LED photomodulation within 5-10 minutes before and within 5-10 minutes after each radiation treatment
12002279|NCT00573365|Radiation|Radiation|Weekly radiation treatment
12002280|NCT00573365|Radiation|Radiation|Weekly radiation treatment
12002281|NCT00573352|Radiation|Far Infrared|Far Infrared Radiation (5μm to 20μm wavelength). Duration is 30 to 40 minutes per session
12002282|NCT00573339|Other|Cardiac MRI|up to 3 Cardiac MRI scans per participant in 1-4 months
12002283|NCT00573326|Drug|Imatinib|200 mg p.o. once a day for 6 months
12002284|NCT00573313|Drug|S-adenosylmethionine|Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.
12002285|NCT00573313|Drug|Placebo|Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
12002286|NCT00573300|Procedure|Phlebotomy|Single blood draw
12002287|NCT00573287|Drug|clozapine|clozapine--tabs, 450mg. max, daily, 24 weeks
12002288|NCT00573287|Drug|risperidone|risperidone--tabs, 6mg max, daily, 24 weeks
12002289|NCT00573274|Device|Physioflow Impedance|6 ECG leads applied to the neck and thorax for the duration of surgery (approximately 1 hour).
12002290|NCT00573261|Drug|Pregabalin|Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.
12002291|NCT00573261|Drug|Placebo|Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.
12002292|NCT00573248|Drug|Nicotine|"21 mg nicotine patches for smokers for 2 days
~7 mg nicotine patches for nonsmokers for 2 days"
12002293|NCT00573248|Other|Placebo|Placebo Patch
12002294|NCT00573222|Drug|Symbicort|
12002295|NCT00573209|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.
12002296|NCT00573196|Radiation|Far infrared|Far infrared radiation (5μm to 15μm wavelength)
12002297|NCT00573183|Behavioral|STAGE-12|The STAGE-12 intervention will consist of a combination of five group and three individual sessions. The five group sessions will be taken from the Project MATCH Twelve Step Facilitation manual as modified for use with drug abusers and adapted for delivery in a group format. The group sessions will be augmented by three individual sessions derived from the introductory and termination sessions from the TSF manual and incorporating elements of the brief intensive 12-step referral procedure.
12002298|NCT00573183|Behavioral|Treatment as Usual|
12002299|NCT00573170|Drug|TREXIMET®|Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
12002300|NCT00573170|Drug|Butalbital-containing Combination Medications (BCM)|butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
12002301|NCT00573170|Drug|placebo|placebo
12002302|NCT00573157|Drug|Atacicept|Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks.
12002303|NCT00573157|Drug|Mycophenolate mofetil|MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
12002304|NCT00573157|Drug|Placebo|Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.
12002305|NCT00573157|Drug|Corticosteroids|High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
12002306|NCT00573144|Drug|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
12002307|NCT00573144|Drug|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator)
12002308|NCT00573131|Drug|OncoGel (Paclitaxel gel)|6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy
12002310|NCT00573131|Drug|5-FU|1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29
12002311|NCT00573131|Radiation|radiation therapy|50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
12002312|NCT00573131|Procedure|esophageal resection|Removal of esophagus after completion of chemotherapy and radiation therapy
12002313|NCT00573105|Procedure|Laparoscopic Ventral hernia repair by heavy weight mesh|Laparoscopic Ventral hernia repair by heavy weight mesh
12002314|NCT00573105|Procedure|Laparoscopic Ventral hernia repair by lighter weight mesh|Laparoscopic Ventral hernia repair by lighter weight mesh
12002315|NCT00573066|Drug|Dexmedetomidine|Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.
12002316|NCT00573053|Other|Oxygen saturation range|Maintain functional oxygen saturation range between 91 and 95%
12002317|NCT00573053|Other|Oxygen saturation range|Maintain functional arterial oxygen saturations in the range of 85- 89%
12002318|NCT00573027|Procedure|noninvasive tests|clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory; Peripheral Artery Tonometry (PAT) testing; Cardiac Magnetic Resonance (CMR) imaging.
12002319|NCT00573014|Other|Cervical Spine Clearance|All OBTPs with gross movement of all four extremities admitted to MetroHealth Medical Center who underwent a CT CS at MHMC between October 2006 and September 2008 will be included. Prospective data will be collected on these patients including age, gender, mechanism of injury, Glasgow Coma Scale (GCS) on admission, results of CT CS, GCS at the time of collar clearance, day of collar clearance, collar complications, date of reexamination, and results of reexamination. We will define an obtunded patient as a patient who was unable to reliably describe the presence or absence of CS symptoms in the opinion of the examining physician. Patients needed to have gross movement of all four extremities to be included in the study. We defined cervical collar complications as skin breakdown identified either by the skin care team during weekly rounds in the intensive care unit or by the treating physician at any time.
12002320|NCT00573001|Drug|Tenofovir/Emtricitabine (Truvada) and Nevirapine|Tenofovir/Emtricitabine(Truvada) 245/200mg 1cp/day ; Nevirapine 200mg 2cp/day after first 14 days
12002321|NCT00573001|Drug|Tenofovir/Emtricitabine/Efavirenz (Atripla)|Tenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day
12002322|NCT00573001|Drug|Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)|Tenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day
12002323|NCT00573001|Drug|Tenofovir/Emtricitabine (Truvada) and Zidovudine|Tenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day
12002324|NCT00572975|Other|Pentadecanoic acid (PA) and Triheptadecanoin (THA)|"Two fats (Pentadecanoic acid and Triheptadecanoin) are administered in a breakfast shake for the purposes of determining malabsorption.
~in breakfast shake x1"
12002325|NCT00572962|Procedure|use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair|use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair
12002326|NCT00572936|Drug|Latanoprost|prostaglandin
12002327|NCT00572936|Drug|Dorzolamide|carbonic anhydrase inhibitor
12002328|NCT00572936|Drug|Timolol|beta blocker
12002329|NCT00572910|Biological|Comparator: Placebo (PBO)|Group 6: Placebo (PBO / PBO / PBO)
12002330|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA
~Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA"
12002331|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA
~Group 4B: V710 (60 mcg / PBO / PBO) with MAA"
12002332|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA
~Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA"
12002333|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA
~Group 2B: V710 (60 mcg / PBO / PBO) without MAA"
12002334|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA
~Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA"
12002335|NCT00572897|Drug|Fludarabine, Melphalan +/- ATG|"Conditioning regimen for Allogenic Stem Cell Transplant:
~Related Donor Fludarabine days -6 to -2 (30mg/m2 IVPB over 30 minutes daily) Melphalan days -3 to -2 (70mg/m2 IVPB over 30 minutes daily)
~Unrelated Donor Fludarabine days -6 to -2 (30mg/m2 IVPB over 30 minutes daily) Melphalan days -3 to -2 (70mg/m2 IVPB over 30 minutes daily) ATG (Thymoglobulin®) days -3 to -1 (0.5 mg/kg IV on day -3 [given over 6 hours], and 2 mg/kg on days -2 and -1 [given over 4 hours])"
12002336|NCT00572884|Other|permethrin insecticide|25 mg neat carbon-14 labelled permethrin applied dermally in isopropyl alcohol, once for 8 hours containing 1 microcurie of carbon-14
12002337|NCT00572871|Other|plyometric exercise|single bout of plyometric exercise
12002338|NCT00572871|Other|resistance exercise|single bout of resistance exercise
12002339|NCT00572871|Other|No exercise|Will not do any exercise
12002340|NCT00572858|Procedure|Blood test|for cholesterol, glucose and insulin levels and levels of various hormones, including but not limited to estrogen
12002341|NCT00572858|Genetic|Blood test|Blood test for genetic testing
12002342|NCT00572858|Procedure|Ultrasound of neck arteries|Non-invasive test using ultrasound waves to measure the thickness of the arteries
12002343|NCT00572858|Procedure|Saliva test|Saliva test for cotisol levels
12002344|NCT00572845|Other|Weaning of Antispasticity Medication|Weaning of antispasticity medication over a three day period and then titration back to previous dose over a three day period.
12002345|NCT00572832|Biological|Quadrivalent human papillomavirus vaccine on-time administration|The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.
12002346|NCT00572832|Biological|Quadrivalent human papillomavirus vaccine delayed administration|The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
12002347|NCT00572819|Drug|Misoprostol|1000 micrograms of self-administered vaginal misoprostol compared to placebo 12 hours before operative hysteroscopy after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
12002348|NCT00572819|Drug|Placebo|Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
12002349|NCT00572806|Drug|insulin aspart|
12002350|NCT00572767|Drug|Dextro-Amphetamin|After a two week baseline phase the patients will receive a dose of 10mg Dexamphetamine on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
12002351|NCT00572767|Other|Glucose|"After a two week baseline phase the patients will receive a dose of 10mg of a placebo (same appearance as the experimental drug) on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
~The treatment of the control group will be the same as for the experimental group except the content of the drug capsule."
12002352|NCT00572754|Procedure|Circumcision|Circumcision by tying a ligature around the foreskin.
12002353|NCT00572741|Dietary Supplement|B12|Methylcobalamin Dose: 75 μg/kg every 3 days
12002354|NCT00572741|Dietary Supplement|Placebo|cellulose
12002355|NCT00572741|Dietary Supplement|folate|Folinic acid: Dose: 400 µg twice a day (BID)
12002356|NCT00572741|Dietary Supplement|B complex|B-Complex: B-1 (3 mg); B-2 (3.4 mg); B-352 (20 mg); B-6 (4 mg;) Pantothenic Acid(10 mg); Biotin (300 mcg); pyridoxal (25mg)
12002357|NCT00572741|Dietary Supplement|vitamin C|Vitamin C 500 mg
12002358|NCT00572741|Dietary Supplement|cod liver oil|Cod liver oil 1/2 teaspoon
12002359|NCT00572741|Dietary Supplement|Mineral complex|Magnesium citrate (200 mg); Selenium (50 mcg); Zinc picolinate (25 mg); Molybdenum (50 mcg); Calcium citrate (400 mg)
12002360|NCT00572741|Dietary Supplement|carnitine|Acetyl L-Carnitine Dose: 250 mg
12002361|NCT00572728|Procedure|CT|Undergo 18F-FLT PET/CT
12002362|NCT00572728|Drug|18F-FLT|Undergo 18F-FLT PET/CT
12002363|NCT00572728|Procedure|PET|Undergo 18F-FLT PET/CT
12002364|NCT00572702|Procedure|Vaginal fixation Amreich-Richter|Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
12002365|NCT00572702|Procedure|Prolift total|Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
12002366|NCT00572689|Drug|Exenatide|10 microgram injected sub-cutaneously once
12002367|NCT00572689|Genetic|Buccal/blood Sample Collection|Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing
12002368|NCT00572663|Drug|ACC (N-acetylcysteine) 1200 mg|N-acetylcysteine (ACC) 1200 mg In the 8-weeks run-in period angiotensin converting enzyme inhibitors and/or angiotensin II subtype 1 receptor antagonists were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 1200 mg N-acetylcysteine in two active treatment periods lasting 8 weeks each
12002369|NCT00572650|Drug|vildagliptin|16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days.
12002370|NCT00572637|Drug|CEP-18770|Administered as intravenous infusion on days 1, 4, 8, and 11 of a 21-day cycle up to 6 cycles. Starting dose 0,1 mg/sqm
12002371|NCT00572624|Behavioral|Diet|Participants attended 20 group behavioral modification sessions led by a behaviorist, a registered dietician, and a physical therapist. The meal plans ranged from 1200 to 1500 kilocalories per day, depending on subject sex and BMI, and were designed to achieve ≤1% body weight loss/week. Participants completed daily food records, and were taught a variety of weight management skills. The exercise component included strength, flexibility, balance, and endurance instruction, gradually increasing to 30 minutes of exercise 5 days/week.
12002372|NCT00572624|Procedure|Gastric bypass surgery|The same surgeon performed all bypass procedures using standard techniques. A small (~20 ml) proximal gastric pouch was created by stapling the stomach, and a 75-cm Roux-en-Y limb was constructed by transecting the jejunum distal to the ligament of Treitz, and creating a jejunojejunostomy 75 cm distal to the transection.
12002373|NCT00572611|Drug|[14C]-bilastine|Single oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only
12002374|NCT00572598|Drug|4- [F-18] fluoropaclitaxel|4- [F-18] fluoropaclitaxel, <84 micrograms, <10 mCi, IV followed by PET/CT imaging
12002375|NCT00572585|Drug|AEB071|
12002376|NCT00572585|Drug|Placebo|
12002377|NCT00572572|Drug|Aprepitant|Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
12002378|NCT00572572|Drug|Placebo|Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
12002379|NCT00572559|Drug|Vancomycin|1 gram IV every 12 hours for 7 to 14 days
12002380|NCT00572559|Drug|Linezolid|600 mg every 12 hours (intravenously [IV] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days
12002381|NCT00572533|Other|ESA Dose Adjustment per standard Anemia Management Protocol|Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
12002382|NCT00572533|Other|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"|"Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by Smart Anemia Manager algorithm"
12002383|NCT00572520|Behavioral|Weight loss treatment|Over 2 years, this treatment involves a total of 26 group visits and 10 individual visits with a health education counselor. Group visits, led by a registered dietitian and a licensed exercise physiologist, will target diet and physical activity.
12002384|NCT00572520|Behavioral|Behavior therapy for depression|Behavior therapy for depression will be delivered by a trained behavior therapist. Participants receiving behavioral counseling will learn about depression, links between activity and mood, and will be asked to keep a diary of moods and activities.
12002385|NCT00572520|Behavioral|Health education counseling|Health education counseling will be delivered by a trained health education counselor. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease.
12002386|NCT00572507|Device|MonoMax®|Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy
12002387|NCT00572494|Device|MAGIC EXPLORER (Biotronik AG)|The lesion is pre-dilated with the PLEON EXPLORER balloon with a length of 10 mm or 15 mm or 20 mm under angiographic control. After dilation, the stenosed area is treated by one AMS implant. If the implanted stent is not fully apposed to the vessel wall or if initial angiography reveals a residual stenosis, the stent may be post-dilated with the delivery system balloon. If necessary, a high-pressure, non-compliant balloon catheter may be used.
12002427|NCT00572234|Drug|bupropion SR|12 week course of bupropion SR 150 mg, BID
12002388|NCT00572494|Device|PLEON EXPLORER (Biotronik AG)|The lesion is dilated with the PLEON EXPLORER balloon with lengths of 10 mm or 15 mm or 20 mm, respectively. In case that the PTA procedure results in a residual stenosis of >50%, the AMS implant should be used to improve the result. A flow-limiting dissection does not qualify for stenting. Best effort must be made to obtain a satisfactory result (e.g. multiple and prolonged inflations) before a patient in the PTA group can be treated with a stent.
12002389|NCT00572481|Procedure|Axillary Reverse Mapping|During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.
12002390|NCT00572468|Drug|Simvastatin|40 mg of simvastatin
12002391|NCT00572468|Other|Placebo|placebo
12002392|NCT00572455|Drug|PF-04217329 - Lowest Dose|1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
12002393|NCT00572455|Drug|PF-04217329 - Low Dose|1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
12002394|NCT00572455|Drug|PF-04217329 - Middle Dose|1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
12002395|NCT00572455|Drug|PF-04217329 - High Middle Dose|1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
12002396|NCT00572455|Drug|PF-04217329 - High Dose|1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
12002397|NCT00572455|Drug|PF-4217329 - Highest Dose|1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
12002398|NCT00572455|Drug|PF-04217329 - Vehicle|1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
12002399|NCT00572455|Drug|Latanoprost Vehicle|1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
12002400|NCT00572455|Drug|PF-04217329 - Low Dose|Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
12002401|NCT00572455|Drug|Latanoprost Vehicle|1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
12002402|NCT00572455|Drug|PF-04217329 - Middle Dose|Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
12002403|NCT00572455|Drug|Latanoprost Vehicle|1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
12002404|NCT00572455|Drug|PF-04217329 - High Dose|Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
12002405|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
12002406|NCT00572455|Drug|PF-04217329 - Low Dose|Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
12002407|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
12002408|NCT00572455|Drug|PF-04217329 - Middle Dose|Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.
12002409|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
12002410|NCT00572455|Drug|PF-04217329 - High Dose|Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.
12002411|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
12002412|NCT00572455|Drug|PF-04217329 - Vehicle|Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
12002413|NCT00572429|Dietary Supplement|l-carnitine|3 gram daily dose
12002414|NCT00572416|Behavioral|Individual Sleep Promotion Plan|Four components, including activity-rest, sleep-wake, psychological distress, and symptom management. Sleep-wake component has four strategies: stimulus control, sleep restriction, relaxation, and sleep hygiene
12002415|NCT00572416|Behavioral|Healthy Eating Control|Equal time and attention and information about healthy eating
12002416|NCT00572390|Drug|oestrogen|Cyclic oestrogen substitution therapy
12002417|NCT00572377|Drug|FemLife Gel|the gel or placebo (240 mcg)applied to the vagina; 20 doses to be used over the 30 day period and to complete the Female Sexual Encounter Profile (FSEP).
12002418|NCT00572377|Drug|Placebo|the gel or placebo (240 mcg) applied to the vagina; 20 doses to be used over the 30 day period and to complete the Female Sexual Encounter Profile (FSEP).
12002419|NCT00572364|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12002420|NCT00572351|Other|Red Wine|8 ounces of assigned beverage (red wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.
12002421|NCT00572351|Other|White Wine|8 ounces of assigned beverage (white wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.
12002422|NCT00572338|Other|No drugs are involved|No treatment or drugs are involved in this research. Participating in this study requires that blood and bone marrow samples be obtained as a part of the diagnostic work-up or follow-up of participant's multiple myeloma. Bone marrow/peripheral blood samples will be collected at the same time for research purposes. Data will be collected including demographic information gathered from your medical record, including gender, date of birth, ethnicity, date of diagnosis, laboratory and pathology results, treatment protocols, dates of relapses, subsequent treatment protocols, and current treatments and medications.
12002423|NCT00572312|Drug|atorvastatin (Sortis) 40 mg|In the 8-weeks run-in period angiotensin-converting enzyme inhibitors and angiotensin II type 1 receptor blockers were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 40 mg of atorvastatin in two active treatment periods lasting 8 weeks each
12002424|NCT00572299|Drug|alendronate|70 mg of alendronate orally per week for at least three months in patients receiving at least 10 mg/day or oral prednisone for at least three months
12002425|NCT00572260|Drug|daptomycin 6 mg/kg IV|daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)
12002426|NCT00572247|Behavioral|Psychiatric Rehabilitation Approach to Weight Loss|The use of psychiatric rehabilitation as a way to lose weight
12002428|NCT00572221|Behavioral|Continuing Quality Improvement and Quality Assurance system|The main intervention is a facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation.
12002429|NCT00572221|Behavioral|CQI and QA System with Best-Practice Care Protocols|A facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. Research clinical staff will also provide best-practice care protocols designed by our research team to address targeted problem conditions.
12002430|NCT00572208|Drug|Gabapentin group|"Gabapentin group:
~Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)
~st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)"
12002431|NCT00572195|Device|RNS® System|The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
12002432|NCT00572182|Drug|MK-0752|This is a dose escalation study. Patients may receive 150, 200, 260 or 325 mg/m2 orally for 3 consecutive days of every 7 days for 28 days (dosing regimen 1 - closed to accrual 2/23/2010) or 800, 1000, 1400, or 1800 mg/m2 orally once weekly for 28 days (1 course). In the absence of unacceptable toxicity or disease progression, treatment may continue for 6 courses.
12002433|NCT00572169|Drug|Velcade|Will be given in central venous catheter
12002434|NCT00572169|Drug|Thalidomide|Capsule taken by mouth
12002435|NCT00572169|Drug|Dexamethasone|A pill taken by mouth
12002436|NCT00572169|Drug|Adriamycin|Given into the vein (IV) by a continuous infusion through a central catheter
12002437|NCT00572169|Drug|Cisplatin|Given into the vein (IV) by a continuous infusion through a central catheter
12002438|NCT00572169|Drug|Cyclophosphamide|Given into the vein (IV) by a continuous infusion through a central catheter
12002439|NCT00572169|Drug|Etoposide|Given into the vein (IV) by a continuous infusion through a central catheter
12002440|NCT00572156|Drug|NutropinAq® (Somatropin [rDNA origin])|rhGH (Somatropin) 45µg/kg once daily injection
12002441|NCT00572156|Drug|Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])|rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
12002442|NCT00572156|Drug|Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])|rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
12002443|NCT00572156|Drug|Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])|rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
12002444|NCT00572143|Other|ca coli follow-up by GP|patients randomized to follow up by GP
12002445|NCT00572130|Genetic|Rexin-G Dose 1|Rexin-G i.v., 1 x 10e11 cfu, two times a week x 4 weeks, rest 2 weeks May be repeated if grade 1 or less toxicity
12002446|NCT00572130|Genetic|Rexin-G Dose 2|Rexin-G i.v., 1 x 10e11 cfu, three times a week x 4 weeks; rest 2 weeks May repeated if grade 1 or less toxicity
12002447|NCT00572117|Drug|Topiramate|Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
12002448|NCT00572104|Other|resistance exercise|12 month training intervention of weight resistance exercise. All participants receive a daily calcium and vitamin D supplement
12002449|NCT00572104|Other|plyometric exercise|12 month training intervention of plyometric exercise. All participants receive a daily calcium and vitamin D supplement
12002450|NCT00572091|Device|PTMA Implant|Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.
12002451|NCT00572078|Drug|Sorafenib|Cohort 1 200 mg po BID D1-5; Cohort 2 200 mg po BID; Cohort 3 400 mg po BID D1-5 Cohort 4 400 mg po BID
12002452|NCT00572065|Drug|arsenic trioxide|"Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Triseonx will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO.
~Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to receive treatment with Trisenox /LDAC for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated."
12002453|NCT00572065|Drug|cytarabine|"Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Trisenox will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO.
~Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to receive treatment with Trisenox /LDAC for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated."
12002454|NCT00572052|Device|NovoFine® needle 6 mm|
12002455|NCT00572052|Device|Ultra-Fine needle 12.7 mm|
12002456|NCT00572039|Behavioral|PST|PST will be delivered in subjects' homes over the course of 6 weeks.
12002457|NCT00572039|Behavioral|ST|ST will be delivered in subjects' homes over the course of 6 weeks.
12002458|NCT00572026|Drug|Methylphenidate Transdermal System|Daytrana wear time up to 15 hours
12002459|NCT00572013|Drug|Rituxan|375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant
12002460|NCT00572013|Drug|BEAM|BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1
12002461|NCT00572013|Procedure|Autologous stem cell transplant|following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
12002462|NCT00572000|Biological|HPV-16/18 L1 VLP AS04 vaccine|Representation: 0.5ml monodose vials Administration: intramuscular Schedule: 0, 1, 6 month
12002463|NCT00571987|Device|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)|Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
12002464|NCT00571974|Device|PDL-585, ScleroPLUS laser|PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue
12002465|NCT00571974|Drug|5-Aminolevulinic Acid (Levulan KerastickTM)|Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze
12002466|NCT00571974|Procedure|Fluorescence Diagnosis Imaging|FD Image taken prior to PDL-585 usage
12002467|NCT00571961|Drug|Kaletra (lopinavir/ritonavir)|4 tablets, once a day (800 mg/dose) on Days 2 through 14 of this study
12002468|NCT00571961|Drug|buprenorphine|Buprenorphine will be obtained through prescription at the subject's drug treatment program.
12002469|NCT00571961|Other|Clinical evaluations/Blood draws|Physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (blood chemistry and blood counts), PK blood draws.
12002470|NCT00571948|Other|more meat and a vegetable oil rich in omega-3 fatty acids|"The vegetable-potato-meat-meal was given 5 to 7 times a week for at least during the seventh to tenth month.
~The intervention meals had more meat (about 13 % of weight) and rapeseed oil (rich in omega-3 fatty acids)."
12002471|NCT00571948|Other|Babyfood with usual meat content and corn oil|The active comparator (which is the control group) got babyfood with usual meat content (8%) and with corn oil, which is rich in omega 6 linoleic acid
12002472|NCT00571935|Drug|insulin aspart|
12002473|NCT00571935|Drug|soluble human insulin|
12002474|NCT00571922|Drug|Acamprosate|2 gr/day (333 mg, TID)
12002475|NCT00571922|Drug|placebo|matching placebo
12002476|NCT00571909|Procedure|video thorascopic splanchnicectomy (VSPL)|VSPL is a minimally invasive technique using 1-2cm incisions through which a camera and surgical tools are placed inside the thoracic cavity and the idea of the procedure is to cut the pain pathway linking the splanchnic ganglion with pain centers in the hypothalamus
12002477|NCT00571896|Drug|Senna+ docusate|Senna+Docusate: dose will be 8.6 mg senna concentrate with 50 mg docusate. The participants will take the medication as follows: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3. If no bowel movement that next morning, take 2 tabs after breakfast. 4. If no bowel movement by evening, take 3 tabs at bedtime 5. If no bowel movement that next morning, take 3 tabs after breakfast 6. Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen. So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
12002478|NCT00571896|Drug|placebo|Placebo pill: The participants will use the placebo pills in the following manner: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3. If no bowel movement that next morning, take 2 tabs after breakfast. 4. If no bowel movement by evening, take 3 tabs at bedtime 5. If no bowel movement that next morning, take 3 tabs after breakfast 6. Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen. So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
12002479|NCT00571883|Other|questionnaire administration|
12002480|NCT00571883|Procedure|psychosocial assessment and care|
12002481|NCT00571883|Procedure|quality-of-life assessment|
12002482|NCT00571883|Procedure|regional lymph node dissection|
12002483|NCT00571883|Procedure|therapeutic conventional surgery|
12002484|NCT00571870|Drug|cetrorelix acetate|The GnRH antagonist, cetrorelix acetate (Cetrotide; Serono) 0.25 mg was added daily, starting when the leading follicle reached 14 mm in diameter during ovarian stimulation for IVF. When the leading follicle reached a mean diameter of 18 mm or two follicles or more reached a diameter of 17 mm, 250 μg of recombinant hCG (Ovidrel; Serono) SQ was injected. In Group A, the GnRH antagonist continued to be used until the day of hCG administration. In Group B, the GnRH antagonist was not administrated on the hCG day
12002485|NCT00571844|Behavioral|DASH diet|Participants in the DASH diet condition receive instruction in modifying the content of their diet to meet DASH guidelines. Participants are explicitly asked not to exercise or to attempt weight loss at this time, and to focus their attention on what they eat. Following the 2-week feeding period, participants will receive instruction on the DASH diet and feedback on their adherence to the diet in a series of half-hour, weekly small group sessions (3 to 5 participants).
12002486|NCT00571844|Behavioral|DASH diet plus Weight loss|Participants in the DASH diet plus weight loss condition will receive the DASH dietary intervention as described in the DASH diet intervention and will participate in a program to promote weight loss consisting of 2 components: Supervised Aerobic Exercise and CBWL (Cognitive Behavioral Weight loss). During supervised exercise participants will exercise 3x/week under medical supervision at the Duke Center for Living. A trained exercise physiologist will supervise all exercise sessions, and will obtain exercise BP measurements to make sure that BP is not abnormally elevated. For the CBWL participants will meet in small groups of 3-5 patients for instruction in weight management techniques. CBWL will include Appetite Awareness Training (AAT), a self-monitoring strategy developed to provide more specific guidelines regarding how much to eat. Individuals learn to identify moderate hunger and fullness and use these internal cues to guide their eating.
12002487|NCT00571831|Procedure|intraocular lens implantation|Intraocular lens implantation
12002488|NCT00571818|Procedure|Oral glucose tolerance test|test done over 2 hours
12002489|NCT00571818|Procedure|IV Glucose Tolerance Test|Done over 4 hours
12002490|NCT00571805|Drug|varencline|2.0 mg/day varencline (1.0 mg BID)
12002491|NCT00571805|Drug|placebo|matching placebo
12002492|NCT00571779|Device|AtriCure Bipolar System|
12002493|NCT00571766|Drug|L-Arginine|Oral L-Arginine 2g, twice a day for 14 weeks
12002494|NCT00571766|Drug|Placebo|Placebo 2 g twice a day for 14 weeks
12002495|NCT00571753|Drug|isoniazid|modified daily isoniazid dose according to NAT2 genotype (appr. 2.5 mg/kg, 5 mg/kg and 7.5 mg/kg for slow, intermediate and rapid acetylators, respectively).
12002496|NCT00571753|Drug|isoniazid|Treatment with a standard isoniazid dose of isoniazid (appr. 5 mg/kg b.w.)
12002497|NCT00571740|Biological|bevacizumab|Given IV
12002498|NCT00571740|Biological|cetuximab|Given IV
12002499|NCT00571740|Drug|fluorouracil|Given IV
12002500|NCT00571740|Drug|leucovorin calcium|Given IV
12002501|NCT00571740|Drug|oxaliplatin|Given IV
12002502|NCT00571727|Drug|mecasermin|injections BID of rhIGF-1, mecasermin
12002503|NCT00571714|Drug|Peginterferon alpha-2a and ribavirin|Peginterferon alpha-2a 180mcg by subcutaneous injection every week and weight based ribavirin, 800 to 1400mg/day by mouth in two divided doses every day for 48 weeks
12002504|NCT00571714|Drug|Peginterferon alpha-2a , ribavirin and betaine|Peginterferon alpha-2a 180mcg given by subcutaneous injection every week plus weight based ribavirin 800 to 1400 mg/day by mouth in divided doses twice a day plus betaine 10 gm dissolved in juice twice a day for twelve weeks followed by peginterferon alpha-2a 180 mcg given by subcutaneous injection every week plus weight based ribavirin 800 to 1400mg/day by mouth in divided doses twice a day for 36 weeks.
12002505|NCT00571701|Drug|celebrex (celecoxib)|Adults: 400 mg celebrex (celecoxib) daily Pediatrics: 100 mg celebrex (celecoxib) daily for weight between 12-25 kg or 200 mg Celebrex (celecoxib) daily for weight >25 kg
12002506|NCT00571701|Drug|placebo|similar appearing capsules containing inert ingredients
12002507|NCT00571688|Drug|Risperdal (risperidone) Consta|Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular (IM) gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.
12002508|NCT00571688|Drug|Treatment as usual|Treatment was provided in this arm based solely on the choice of the treatment provider and participant. Treatment providers were not part of the study staff and were completely free to make treatment choices except that they were not allowed to select a long-acting injectible.
12002509|NCT00571675|Drug|AT-101, prednisone and docetaxel|docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3
12002510|NCT00571675|Drug|placebo, prednisone and docetaxel|docetaxel (75mg/m2 intravenously over 1 hour every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3
12002511|NCT00571662|Drug|Pentostatin|4 mg/m^2 intravenous(IV)once a day(QD)x3days (days -10, -9, -8)
12002512|NCT00571662|Radiation|Total-body irradiation (TBI)|TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. TBI will be given on day -1.
12002513|NCT00571662|Drug|Cyclosporine A (CsA)|CsA will be given at 2.0 mg/kg intravenous (IV) Q 12hrs on days -1,0,and+1 (total 6 doses) then converted to oral at 2 mg/kg by mouth (PO) twice a day (BID) until day+80, then tapered 10% per week over approximately 3 months if no GVHD for related donor transplants. For unrelated CsA will be given at same dose and schedule until day+100 then tapered by 10% per week if no GVHD
12002514|NCT00571662|Drug|Mycophenolate Mofetil (MMF)|MMF 15 mg/kg by mouth twice a day (PO BID) will be given from day 0-27 then stopped without tapering for related donor transplants. For unrelated donor transplants MMF will be given at same dose until day+40 then tapered over 2months. in absence of GVHD. Doses will be rounded to nearest 250 mg.
12002515|NCT00571662|Drug|G-CSF|10 mcg/kg/day subcutaneously for at least 4 consecutive days.
12002516|NCT00571649|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
12002517|NCT00571649|Drug|Enoxaparin|Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days
12002518|NCT00571649|Drug|Rivaroxaban placebo|Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days
12002519|NCT00571649|Drug|Enoxaparin placebo|Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
12002520|NCT00571636|Drug|Fentanyl|"The experimental drug will be diluted according to each NICU scheme and administered as an attach dose of 1 mcg/kg in 30' followed by continuous i.v. infusion of 1 mcg/kg/h. Infusion of the experimental drug has to begin within 24 hrs from the beginning of MV and has to be continued until the end of MV and not after 7 days of life. If the newborn is still on MV after the 7th day of life he/she will be treated for pain according to local protocols.
~Open label boluses of Fentanyl during the study phase will be administered, in both groups when the EDIN pain score is > 6 and before performing the following invasive procedures:Peripherally inserted central venous catheter positioning;Re-intubation;Lumbar puncture;Pneumothorax or hydrothorax drainage."
12002521|NCT00571636|Drug|5% glucose solution|ev continuous infusion
12002522|NCT00571623|Other|Chest Physiotherapy|10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU
12002523|NCT00571610|Device|PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant|Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.
12002524|NCT00571584|Drug|activated recombinant human factor VII|
12002525|NCT00571571|Behavioral|Psychotherapy|Individual psychotherapy with parent collateral/psychoeducation as necessary.
12002526|NCT00571571|Behavioral|Individual Psychotherapy|Individual psychotherapy and family interventions (as needed)
12002527|NCT00571558|Drug|aminolevulinic acid hydrochloride|Given PO
12002528|NCT00571558|Drug|photodynamic therapy|Undergo photodynamic therapy
12002529|NCT00571558|Other|laboratory biomarker analysis|Correlative studies
12002530|NCT00571545|Behavioral|Aerobic exercise|A supervised aerobic exercise program occurred weekly for 30 minutes with a 15 minute warm-up and a 15 minute cool down. A half hour educational session on aspects of exercise and overcoming barriers to exercise was also instituted.
12002531|NCT00571545|Behavioral|No exercise|Controls were wait-listed for the exercise program during the 10 week study period.
12002532|NCT00571519|Drug|Rivoglitazone HCl|0.5 mg tablets
12002533|NCT00571519|Drug|rivoglitazone HCl|1.0 mg tablets
12002534|NCT00571519|Drug|rivoglitazone HCl|1.5 mg tablets
12002535|NCT00571519|Drug|placebo|placebo tablets matching rivoglitazone tablets
12002536|NCT00571519|Drug|pioglitazone HCl|15 mg tablets
12002537|NCT00571519|Drug|pioglitazone HCl|30 mg tablets
12002538|NCT00571519|Drug|pioglitazone HCl 45 mg|45 mg tablets
12002539|NCT00571519|Drug|placebo|placebo capsules for pioglitazone
12002540|NCT00571519|Drug|metformin|Oral tablets. Rescue medication.
12002541|NCT00571506|Drug|Rosiglitazone|Rosiglitazone 4 mg tablets by mouth daily for 3 months
12002542|NCT00571506|Drug|Pioglitazone|Pioglitazone 30 mg tablet by mouth once daily
12002543|NCT00571493|Drug|Bortezomib|Patients will receive bortezomib in four dose cohorts ( .8. 1.0, 1.3, 1.5 mg/m²). Patients will receive bortezomib on days -11, -8, -5, and -2 before infusion of autologous stem cells.
12002544|NCT00571493|Drug|BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)|"All study patients will receive BEAM per the standard institution protocol:
~BCNU (carmustine): 300 mg/m²on day -5 etoposide 100 mg/m² twice daily on days -5, -4, -3, and -2 cytarabine 100 mg/m² twice daily on days -5, -4, -3, -2 melphalan: 140 mg/m² on day -1 before infusion of autologous stem cells."
12002545|NCT00571480|Other|acupuncture|ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
12002546|NCT00571480|Other|Sham acupuncture|ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
12002547|NCT00571480|Other|standard of care|participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
12002548|NCT00571467|Drug|PRTX-100 (Staphylococcal protein A)|"4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels:
~Cohort 1: 0.075 mcg/kg
~Cohort 2: 0.15 mcg/kg
~Cohort 3: 0.30 mcg/kg"
12002549|NCT00571454|Behavioral|telephone depression care management|"1 call per week for first 4 weeks
~1 call every other week for next 8 weeks"
12002550|NCT00571428|Drug|Arformoterol Tartrate Inhalation Solution|Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)
12002551|NCT00571428|Drug|Arformoterol Tartrate Inhalation Solution|Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)
12002552|NCT00571428|Drug|Placebo|Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day
12002553|NCT00571402|Behavioral|Family-focused therapy for adolescents|FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.
12002554|NCT00571402|Behavioral|Enhanced care|Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.
12002555|NCT00571376|Other|Health information technology and exchange|Health information technology includes electronic health records, electronic prescribing, and electronic results notification and/or viewers. Health information exchange includes use of central repositories of data and peer-to-peer models.
12002556|NCT00571363|Procedure|standard surgery|excision with 4 mm margins
12002557|NCT00571363|Procedure|Mohs micrographic surgery|excision of basal cell carcinoma with 2 mm margins and immediate examination of margins for residual tumour. residual tumour was excised until complete tumour removal was achieved.
12002558|NCT00571350|Procedure|tvt-o operation|transvaginal tention free obturator tape
12002559|NCT00571350|Procedure|tvt o operation|transobturator vaginal tape insertion
12002560|NCT00571337|Drug|Infliximab|Stopping infliximab in patients having been treated with this drug for at least one year and in stable remission for at least 6 month.
12002561|NCT00571324|Drug|Exendin-(9-39)|A short term intravenous infusion of the study drug, exendin-(9-39), will be given over 6 hours.
12002562|NCT00571324|Other|Vehicle|A short term intravenous infusion of normal saline, or the vehicle, will be given over 6 hours.
12002563|NCT00571298|Procedure|Extrapleural pneumonectomy (EPP)|Resection of the lung, the lining of the lung (pleura), the covering of the heart (pericardium), and the muscle that separates the chest and abdomen (diaphragm)
12002564|NCT00571298|Drug|Cisplatin|Given after the tumor is removed as a bath (perfusion) for one-hour
12002565|NCT00571298|Drug|gemcitabine|Given after the tumor is removed as a bath (perfusion) for one-hour
12002566|NCT00571298|Drug|amifostine|Given intravenously before perfusion chemotherapy and then 2 hours after the first dose
12002567|NCT00571298|Drug|sodium thiosulfate|Given intravenously immediately at the end of perfusion chemotherapy
12002568|NCT00571298|Procedure|Pleurectomy/Decortication|Resection of the lining of the lung (pleura), while the lung remains intact.
12002569|NCT00571285|Dietary Supplement|Vitamin D3|600 IU Vitamin D3 capsule daily
12002570|NCT00571285|Dietary Supplement|Vitamin D3 - high dose|50,000 IU Vitamin D3 capsule once a week
12002571|NCT00571285|Dietary Supplement|Placebo|Placebo capsule given once a week
12002572|NCT00571259|Drug|Heparin 1000U/mL|A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
12002573|NCT00571259|Drug|4% Sodium Citrate with Gentamicin 320 mcg/mL|A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
12002574|NCT00571246|Drug|Topiramate|Participants are randomized to take Topiramate (250mg/day) 2 times a day
12002575|NCT00571246|Drug|lamotrigine|Participants are randomized to take Lamotrigine (250 mg/day) 2 times a day
12002576|NCT00571246|Other|Placebo|Participants are randomized to take placebo
12002577|NCT00571220|Procedure|gastric bypass surgery|weight loss bariatric surgery
12002578|NCT00571220|Other|Diet induced weight loss|low calorie diet with meal replacements. weekly outpatient visits with nutritionist.
12002579|NCT00571207|Device|On-site oral fluid screening devices|Comparison of screening device results to oral and/or blood sample results
12002580|NCT00571207|Behavioral|Checklist: drug recognition expert|Correlation of drug recognition expert observations to findings for drugs in non-suspected/suspected cases
12003066|NCT00567489|Drug|Dianeal|Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
12002581|NCT00571194|Drug|pravastatin|"A single 10 mg dose of pravastatin will be administered 3 mL blood samples for pravastatin Pharmacokinetic evaluations will be collected at 0.5, 1, 2, 3, 4, 6, and 8 hours. 5 mL blood samples for pravastatin PK and laboratory evaluations will be drawn at pre-dose and 24 hours.
~Vital Signs and Physical Exams will also be done throughout the study"
12002582|NCT00571181|Device|Closed-loop system|Automatic delivery of propofol and remifentanil
12002583|NCT00571181|Device|TCI (Infusion Toolbox)|TCI administration of propofol and remifentanil
12002584|NCT00571168|Drug|Emend|125 mg/d on day 1; 80 mg/d on day 2-4
12002585|NCT00571168|Drug|Placebo|Placebo capsules on day 1-4
12002586|NCT00571155|Drug|levetiracetam|oral and intravenous dosing 2000-3000 mg per day
12002587|NCT00571142|Procedure|Bevacizumab + Pars plana vitrectomy|2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
12002588|NCT00571142|Procedure|Bevacizumab + pars plana vitrectomy|2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy
12002589|NCT00571129|Procedure|DCR with no tubes or mitomycin|"The patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR.
~In revision group patients were randomized into the two groups,ether with or without application of mitomycin C after DCR"
12002590|NCT00571116|Drug|Disulfiram|Given PO
12002591|NCT00571116|Drug|Arsenic trioxide|Given IV
12002592|NCT00571103|Drug|acamprosate|Two 333mg tablets taken three times daily.
12002593|NCT00571090|Procedure|Thyroid ultrasonography|Ultrasound-guided thyroid fine-needle aspiration biopsy
12002594|NCT00571077|Device|Electrical Impedance Scanning (EIS) of the Thyroid gland|Patients will be examined in the supine position. A cylinder electrode conveying 2.5V electrical current will be held by the patient. The patient will be scanned by a probe (similar to an ultrasound probe. The examination takes 5 minutes and there is no risk or discomfort.
12002595|NCT00571064|Drug|Donepezil HCl|One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.
12002596|NCT00571051|Behavioral|Mindfulness Based Stress Reduction|8 week course in mindfulness training
12002597|NCT00571038|Behavioral|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
12002598|NCT00571038|Behavioral|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
12002599|NCT00571025|Behavioral|APOE Disclosure|Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
12002600|NCT00570999|Drug|Palifermin|60 mg/kg/day
12002601|NCT00570999|Other|Placebo|1,2 mL once daily
12002602|NCT00570986|Drug|Placebo|Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
12002603|NCT00570986|Biological|ABT-874|200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
12002604|NCT00570986|Biological|ABT-874|100mg every 12 weeks.
12002605|NCT00570973|Procedure|endoscopic band ligation|Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices
12002606|NCT00570973|Procedure|TIPS-Implantation|Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,
12002607|NCT00570960|Drug|Dextran 70|dextran 70, 1.0 g/kg on days one, two and three
12002608|NCT00570960|Biological|human albumin|human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
12002609|NCT00570947|Other|CPR Anytime Kit|The study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program
12002610|NCT00570934|Dietary Supplement|Cholecalciferol|2000IU Cholecalciferol P.O. Q.D.
12002611|NCT00570934|Dietary Supplement|Calcium|1 gm calcium as calcium carbonate
12002612|NCT00570934|Dietary Supplement|Calcium and cholecalciferol|2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
12002613|NCT00570934|Drug|Placebo|Placebo
12002614|NCT00570921|Drug|Everolimus|Everolimus tablets, two-5 mg tablets a day
12002615|NCT00570921|Drug|Fulvestrant|intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter
12002616|NCT00570908|Drug|sunitinib|Sutent
12002617|NCT00570908|Drug|capecitabine|concurrently
12002618|NCT00570908|Radiation|WBRT|Whole Brain Radiotherapy 30 Gy in 10 fractions
12002619|NCT00570895|Dietary Supplement|Vitamin C|"Visit 1: Subjects will receive 1mg iron-58 sulfate as an aqueous solution with 50mg ascorbic acid.
~Visit 2: Subjects will consume a meal of a bread muffin labelled with 4mg of iron-57 as ferrous fumarate, and a glass of apple juice containing 0 or 25mg ascorbic acid.
~Visit 3: During this admission the apple juice will contain either 0 or 25mg ascorbic acid, the opposite of what was given to the subject in visit 2."
12002620|NCT00570882|Drug|Sunitinib 2/1|Sunitinib 50 mg PO 2 weeks followed by 1 week rest
12002621|NCT00570882|Drug|Sunitinib 4/2|Sunitinib 50 mg PO 4 weeks followed by 2 week rest
12002622|NCT00570869|Other|CPR Anytime|These participants will be consented, surveyed, asked to watch a 22-minute instructional Infant CPR DVD with an infant manikin.
12002623|NCT00570856|Drug|Folic acid|Folic acid 5 mg/day
12002624|NCT00570856|Drug|Placebo|Placebo similar to the folic acid tablets, 1/day
12002625|NCT00570843|Drug|New PEG based artificial tear|1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)
12002626|NCT00570843|Drug|Optive|1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)
12002627|NCT00570830|Device|Retisert (fluocinolone acetonide implant)|Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens.
12002628|NCT00570817|Other|12 hours of prehydration|12 hours of prehydration with an infusion rate of 150 ml/m2/hour with a solution of 5% glucose with 40 mmol sodium bicarbonate/L and 20 mmol potassium chloride/L.
12002629|NCT00570804|Behavioral|Telephone Counseling|7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete.
12002630|NCT00570804|Behavioral|Telephone Assessments|4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.
12002631|NCT00570791|Device|Tonometer|Tonometer devices used to measure IOP: Pascal Dynamic Contour Tonometer, Goldman Applanation Tonometer, Tono Pen, Reichart pneumatonometer, Langham Ocular Blood Flow, Schiotz Tonometer and ICare tonometer
12002632|NCT00570778|Drug|indacaterol/glycopyrrolate|Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
12002633|NCT00570778|Drug|indacaterol|Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
12002634|NCT00570778|Drug|placebo|Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
12002635|NCT00570765|Drug|Placebo|Placebo
12002636|NCT00570765|Drug|INT-747|10 mg po qd
12002637|NCT00570765|Drug|INT-747|50 mg po qd
12002638|NCT00570752|Other|Placebo|
12002639|NCT00570752|Drug|BMS-582949|
12002640|NCT00570752|Drug|Atorvastatin|
12002641|NCT00570752|Drug|Statin|
12002642|NCT00570739|Drug|Metformin HCl and Colesevelam Placebo|One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
12002643|NCT00570739|Drug|Metformin HCl tablets and Colesevelam tablets|One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
12002644|NCT00570739|Drug|Colesevelam placebo|Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
12002645|NCT00570739|Drug|Colesevelam|Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
12002646|NCT00570726|Drug|Ranibizumab (Lucentis)|
12002647|NCT00570713|Drug|MORAb-009|Monoclonal antibody administered once weekly by intravenous injection.
12002648|NCT00570713|Drug|Placebo|As per package insert.
12002649|NCT00570713|Drug|Gemcitabine|Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
12002650|NCT00570700|Drug|Dasatinib|150mg (3 pills) orally daily for as long as the drug benefits
12002651|NCT00570687|Drug|Technosphere Insulin|Inhalation 15U/30U
12002652|NCT00570674|Drug|Abraxane|
12002653|NCT00570674|Drug|Erbitux|
12002654|NCT00570674|Drug|Carboplatin|
12002655|NCT00570674|Radiation|Intensity Modulated Radiation Therapy|
12002656|NCT00570661|Drug|ITF2357|ITF2357 will be supplied as hard gelatine capsule for oral administration at the dose strengths of 7.5, 10, 12.5, 15, 20 and 50 mg, identifiable by different colours. The dose of 1.5 mg/kg/day will be achieved by administration, at 12-hour interval, of an appropriate number of capsules of definite strength(s) as specified here below
12002657|NCT00570648|Drug|sodium hyaluronate|1% sodium hyaluronate applied at the end of corneal transplant surgery. The amount will be determined on how much is necessary to cover the ocular surface.
12002658|NCT00570635|Drug|XL820|XL820 capsules administered orally as a single agent at a dose of 800 mg daily
12002659|NCT00570635|Drug|XL820|XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily
12002660|NCT00570622|Drug|Pioglitazone|Patients receive 60mg of pioglitazone once a day orally for 9 days
12002661|NCT00570622|Drug|Placebo|Patients receive placebo once a day orally for 9 days
12002662|NCT00570609|Other|CPR Anytime education|After consent, participants will be asked to complete the 22 minute DVD CPR Anytime program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program
12002663|NCT00570570|Procedure|Muscular Strengthening for paretic knee flexor and extensor|thrice a week during 6 weeks
12002664|NCT00570570|Other|conventional physiotherapy|trice a week during 6 weeks
12002665|NCT00570557|Other|TOR-BSST© Refresher Training|Web-based refresher training in dysphagia screening
12002666|NCT00570544|Drug|tiotropium|18ug capsule daily for 30 days
12002667|NCT00570531|Drug|Bevacizumab|Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days # 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
12002668|NCT00570531|Drug|Paclitaxel|Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m2 will be administered as a 1-hour intravenous infusion on days #2, 9, 16, 23, and 30. It will be given before cisplatin administration.
12002669|NCT00570531|Drug|Cisplatin|Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m2 over 1 hour on days #2, 9, 16, 23, and 30. It will be given after paclitaxel.
12002670|NCT00570531|Drug|5-Fluorouracil|Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
12002671|NCT00570531|Radiation|Radiation Therapy|Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays. CT scans, the barium swallow, the endoscopy and endoscopic ultrasound reports and PET scans should be used for tumor definition. Post-Operative Radiotherapy: In the event that gross residual disease is left behind at the time of surgery or the patient is found to have a microscopic positive deep or gastric margin following surgery, additional treatment with radiation therapy will be considered.
12002672|NCT00570531|Procedure|Esophagectomy|Transhiatal esophagectomy performed on approximately Day #57 (6 weeks after last dose of bevacizumab.)
12002673|NCT00570505|Device|LAP-BAND System|Reduction of food intake due to creation of smaller stomach pouch
12002674|NCT00570492|Drug|Fluticasone furoate nasal spray|Fluticasone furoate nasal spray 110mg QD
12002675|NCT00570492|Drug|Placebo nasal spray|Placebo nasal spray
12002676|NCT00570479|Drug|anecortave acetate|Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
12002677|NCT00570466|Behavioral|Video Games|Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit,vegetable,water intake + physical activity + decrease TV viewing.
12002678|NCT00570466|Behavioral|Web and DVD knowledge|Web and DVD based knowledge games
12002679|NCT00570440|Drug|Oral contraceptives--ethinyl estradiol, levonorgestrel|3 visits - screening/enrollment, 6-months and 12 months
12002680|NCT00570427|Behavioral|Problem Solving Therapy (PST)|Counseling
12002681|NCT00570427|Behavioral|Medication Management|If a participant chooses to receive antidepressant medication while in the study, a depression care specialist works with the participant's usual primary care provider to initiate an appropriate prescription and to follow-up with side effects, adherence, efficacy, etc. on a monthly or biweekly basis.
12002682|NCT00570414|Device|Laryngeal mask airway|Airway management by the use of the flexible, reinforced laryngeal mask airway
12002683|NCT00570414|Device|Endotracheal tube|Airway management by the use of endotracheal tube
12002684|NCT00570401|Drug|dasatinib|
12002685|NCT00570388|Drug|Prometa Treatment Program|"Day 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion. Flumazenil infusion.
~Day 1•Gabapentin 300 mg po 9PM w/ hydroxyzine HCL 50 mg PRN for sleep.
~Day 2•Gabapentin 600 mg po 9PM w/ hydroxyzine HCL 50 mg PRN
~Day 3•Gabapentin 900 mg po 9PM w/ hydroxyzine HCL 50 mg PRN
~Days 4 through 28•Gabapentin 1200 mg po 9 PM
~Days 29 through 31•Gabapentin 900 mg po 9 PM
~Days 32 through 34•Gabapentin 600 mg po 9 PM
~Days 35 through 38•Gabapentin 300 mg po 9 PM
~Flumazenil Dosing Schedule
~2 mg flumazenil is given as a slow IV push. Subjects in the placebo group will receive placebo flumazenil, gabapentin, and hydroxyzine; subjects in the active group will receive flumazenil, gabapentin, and hydroxyzine per protocol."
12002686|NCT00570375|Drug|Erlotinib|150 mg, PO, QD beginning day 1 week 1. Patients will receive treatment for 16 weeks as long as there is no evidence of disease progression. In no response is noted after 16 weeks of treatment, patients will be taken off the study. Patients achieving response (HI, CR, or PR) will continue on treatment until evidence of disease progression or relapse.
12002687|NCT00570349|Drug|Nitric Oxide for Inhalation|Nitric oxide will be administered at 20 ppm via nasal cannula over a 44 hour period.
12002688|NCT00570349|Drug|Nitric Oxide for Inhalation|Nitric oxide will be administered at 40 ppm via nasal cannula over a 44 hours period.
12002689|NCT00570349|Drug|Nitrogen|100% nitrogen (placebo) will be administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period.
12002690|NCT00570336|Drug|CTS-1027|Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).
12002691|NCT00570336|Other|Placebo|Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd.
12002692|NCT00570323|Drug|Arimidex|Aromatase inhibitors
12002693|NCT00570323|Drug|Faslodex|Hormone Receptor
12002694|NCT00570310|Drug|Comparator: pregabalin|pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
12002695|NCT00570310|Drug|Comparator: Placebo (unspecified)|pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
12002696|NCT00570284|Drug|LBH589|orally administered panobinostat at 20 mg twice weekly (core phase); orally administered panobinostat 45 mg twice weekly if 20 mg twice weekly was tolerated in Cycle 1 (extension phase)
12002697|NCT00570271|Other|Placebo with BP dec (written form)|Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
12002698|NCT00570271|Other|Placebo with BP dec (doctor)|Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
12002699|NCT00570271|Other|Placebo with BP inc (written)|Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
12002700|NCT00570271|Other|Placebo with BP inc (doctor)|Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
12002701|NCT00570271|Other|Placebo info given (written)|Subject informed about receiving placebo. Information provided to subjects in written form.
12002702|NCT00570271|Other|Placebo info given (doc)|Subject informed about receiving placebo. Information provided to subjects by doctor.
12002703|NCT00570258|Drug|Fulvestrant|Fulvestrant: 250 mg IM Q 4 weeks
12002704|NCT00570258|Drug|erlotinib|150 mg PO QD
12002705|NCT00570258|Drug|Fulvestrant|250 mg IM Q 4 weeks
12002706|NCT00570258|Drug|Placebo|Placebo 150 mg PO QD
12002707|NCT00570245|Drug|Nitric oxide|inhalation, 10 ppm, for up to 48 hours
12002708|NCT00570245|Drug|Nitric oxide|inhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient)
12002709|NCT00570232|Drug|Erlotinib|150 mg per day by mouth for 12 months
12002710|NCT00570219|Drug|valproate|Valproate 20 mg/kg per day for 2 weeks, reduction during week 3. Conversion of benzodiazepines to an equivalent dose of diazepam (maximum 80 mg per day). Dosage reduced 10 mg daily until 40 mg per day. Reduction then continued 5 mg daily.
12002711|NCT00570206|Behavioral|Motivational Interviewing|Probation officers trained to use Motivational Interviewing while conducting meetings with probationers.
12002712|NCT00570193|Drug|verteporfin (Visudyne)|Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1
12002713|NCT00570193|Drug|ranibizumab (Lucentis)|ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol
12002714|NCT00570180|Drug|Bortezomib|21 day-cycle Induction therapy:bortezomib 1.3 mg/m2 (I.V. Days 1, 4, 8, and 11), then 10-day rest period. DOXIL 30 mg/m2 given after bortezomib (I.V. infusion Day 4 of each cycle). Dexamethasone 40 mg PO on days 1-4,8-11 and 15-18 during the first cycle. Subsequent 3 cycles, dexamethasone 40 mg PO given on days 1-4 and 11-14. Patients who don't progress may undergo elective stem cell mobilization, stem cell collection and cryopreservation. Patients will then receive post-induction therapy 1.5 mg/m2 bortezomib days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days for 8 monthly 28 day cycles.Maintenance therapy with weekly 40 mg dexamethasone (days 1, 8, 15 and 22) every month until disease progression occurs.
12002715|NCT00570167|Procedure|Hip resurfacacing|Hip resurfacing with cementless acetabular cup and cemented femoral head
12002716|NCT00570167|Procedure|Cementless total hip arthroplasty with m-o-m bearings|Cementless monoblock acetabular cup and cementless femoral stem with modular large head and metal-on-metal bearings..
12002717|NCT00570141|Device|OASIS Wound Matrix|OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).
12002718|NCT00570128|Drug|Donepezil hydrochloride|Oral liquid.
12002719|NCT00570128|Drug|Placebo|Oral liquid.
12002720|NCT00570102|Dietary Supplement|A highly hydrolyzed formula|Weaning to a highly hydrolyzed formula, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin up to the age of 6-8 months
12002721|NCT00570102|Dietary Supplement|A regular cow's milk based formula|Weaning to a regular cow's milk based formula supplemented with 20% of the highly hydrolyzed formula used in arm 1 to make the study formulas similar in smell and taste, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin
12002722|NCT00570089|Drug|Ranolazine|500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval.
12002723|NCT00570089|Drug|Placebo|Placebo, 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval.
12002724|NCT00570063|Drug|PF-02545920|Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days
12002725|NCT00570063|Drug|Placebo|Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
12002726|NCT00570050|Drug|Diluent / Insulin|Diluent (4 Weeks ) / Intranasal insulin (4 weeks)
12002727|NCT00570050|Drug|Insulin / Diluent|Intranasal Insulin (4 Weeks ) / Diluent (4 Weeks)
12002728|NCT00570037|Biological|Trivalent inactivated influenza vaccine|Intramuscular injection, 0.5 mL or 0.25 mL depending on age of vaccine recipient, one or two doses administered a month apart depending on age and prior influenza vaccination history of recipient
12002729|NCT00570024|Procedure|Traditional Acupuncture|In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
12002730|NCT00570024|Procedure|AA|In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
12002731|NCT00570011|Drug|Somatropin|3 microg/kg/day for the first three months.The dose was then doubled (6 microg/kg/day) for the next three-months.
12002732|NCT00570011|Drug|Somatropin|6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.
12002733|NCT00569998|Device|NovoPen™ 4|
12002734|NCT00569998|Device|NovoPen® 3|
12002735|NCT00569985|Biological|lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells|Undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells
12002736|NCT00569985|Drug|carmustine|Given IV
12002737|NCT00569985|Drug|cyclophosphamide|Given IV
12002738|NCT00569985|Drug|etoposide|Given IV
12002739|NCT00569985|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells
12002740|NCT00569972|Drug|PD 0200390|Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
12002741|NCT00569972|Drug|PD 0200390|Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
12002742|NCT00569972|Drug|PD 0200390|Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
12002743|NCT00569972|Drug|PD 0200390|Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
12002744|NCT00569972|Drug|Placebo|Matched oral placebo for weeks 2-7.
12002745|NCT00569959|Other|fasting 12+ hours|fasting 12+ hours
12002746|NCT00569959|Other|Non-fasting|Non-fasting
12002747|NCT00569946|Drug|AG-013736|"AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID.
~Number of cycles: until progression or unacceptable toxicity develops."
12002748|NCT00569933|Behavioral|Audio recording|Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.
12002749|NCT00569920|Drug|dexamethasone|IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL).
12002750|NCT00569920|Drug|natriumchloride 0,9%|iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
12002751|NCT00569920|Drug|dexamethasone|IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.
12002752|NCT00569894|Biological|FLuMist|One or two vaccinations with FluMist depending on prior vaccination status.
12002753|NCT00569894|Biological|TIV (Injection)|One or two injections of TIV depending on previous status.
12002754|NCT00569894|Other|Unvaccinated Control|no vaccine
12002755|NCT00569881|Drug|gatifloxacin and moxifloxacin|Comparison of wound healing between drugs
12002756|NCT00569868|Drug|Velcade|"Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade.
~The platelet Aggregation Test will be done only if Platelet count is 100 000."
12002757|NCT00569855|Drug|Phenoxybenzamine|0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU
12002758|NCT00569829|Behavioral|cognitive behavioral therapy|1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
12002759|NCT00569816|Drug|Sevoflurane|1 MAC Sevoflurane will be given either continuously after induction of anesthesia until initiation of cardiopulmonary bypass or will be repetitively washed in and out twice before initiation of cardiopulmonary bypass.
12002760|NCT00569803|Drug|belatacept|single dose, 116 days
12002761|NCT00569803|Drug|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
12002762|NCT00569790|Drug|S-1, Irinotecan, Bevacizumab|"S-1 is administered orally on days 1 to 14 of a 28-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
~Irinotecan 100 mg/m2 is administered by intravenous infusion on days 1 and 15. Bevacizumab 5 mg/kg (body weight)is administered by intravenous infusion on days 1 and 15."
12002763|NCT00569777|Device|K-Lens (generic name not established) and Ketotifen|combination drug-device product: contact lens (device) and anti-allergy drug
12002764|NCT00569777|Device|Placebo Lens|contact lens without drug
12002765|NCT00569751|Device|TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System|Drug Eluting Stent used to treat de novo coronary artery lesions.
12002766|NCT00569738|Procedure|PET scan with Ga68-DOTANOC|Imaging: PET scan with Ga68-DOTANOC
12002767|NCT00569712|Drug|budesonide/formoterol fumarate dihydrate inhalation aerosol|
12002768|NCT00569712|Genetic|DNA methylation analysis|
12002769|NCT00569712|Genetic|comparative genomic hybridization|
12002770|NCT00569712|Genetic|microarray analysis|
12002771|NCT00569712|Other|bronchoalveolar lavage|
12002772|NCT00569712|Other|immunoenzyme technique|
12002773|NCT00569712|Other|laboratory biomarker analysis|
12002774|NCT00569712|Procedure|bronchoscopy|
12002775|NCT00569699|Drug|S-1, Bevacizumab|"S-1 is administered orally on days 1 to 28 of a 42-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25 m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
~Bevacizumab 5 mg/kg (body weight) is administered by intravenous infusion on days 1, and 15."
12002776|NCT00569686|Drug|lovaza|lovaza 4 gm po daily
12002777|NCT00569686|Drug|placebo|placebo
12002778|NCT00569673|Biological|filgrastim|
12002779|NCT00569673|Biological|pegfilgrastim|
12002780|NCT00569673|Drug|docetaxel|
12002781|NCT00569673|Drug|trabectedin|
12002782|NCT00569660|Drug|Azacitidine|75 mg/m^2 subcutaneous daily for 7 days (every 4 week cycle)
12002783|NCT00569647|Device|Virtual Reality Hypnosis|Use of virtual reality headset to induce hypnotic state
12002784|NCT00569647|Device|Placebo|no use of device
12002785|NCT00569634|Procedure|Venous blood gas analysis|When an ABG is deemed to be necessary as part of ICU management, a central venous sample will also be obtained with minimum delay (always < 2 minutes) between the samples. The samples will be analyzed by a blood gas analyzer as quickly as possible.
12002786|NCT00569621|Drug|Moxaverine|intravenous administration
12002787|NCT00569621|Drug|physiological saline|intravenous administration
12002788|NCT00569608|Other|Early Discharge|Application of an early discharge protocol from the neonatal intensive care unit.
12002789|NCT00569595|Behavioral|Self-Care Stimulating Disease Prevention Program|The intervention is aimed at improving diet, increasing physical activity, and reducing sedentary behaviors among low-income patients, assuming that this will increase motivation and self-confidence to adhere to self-care regimens based on personal prioritizing and progressive goal setting.
12002790|NCT00569595|Behavioral|Fighting Cancer with Advice|"Patient health counseling program by lay health educators entitled Fighting Cancer with Advice."
12002791|NCT00569582|Drug|mifepristone|Patients take mifepristone by mouth once a day. The dose is increased during scheduled timepoints during the study or until symptoms improve or the highest dosage allowed is reached. Dose escalation will be based upon weight. During clinic visits, blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis will be performed.
12002792|NCT00569569|Drug|juxtascleral depot injection of Retaane|juxtascleral depot injection of Retaane
12002793|NCT00569556|Other|Case Management|Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed
12002794|NCT00569543|Other|high performance liquid chromatography|urine analysis
12002795|NCT00569543|Other|laboratory biomarker analysis|The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
12002796|NCT00569543|Other|mass spectrometry|The urine samples will be analyzed for 40 estrogen metabolites, conjugates and depurinating DNA adducts by UPLC with tandem mass spectrometric detection.
12002797|NCT00569543|Other|medical chart review|Collection of information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease.
12002798|NCT00569530|Drug|Infasurf (ONY Inc.)|Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.
12002799|NCT00569530|Drug|Sham|Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
12002800|NCT00569517|Behavioral|CBT|6-CBT based sesions
12002801|NCT00569517|Other|educational|subjects receive one hour of nutrition education and 5 weekly phone calls
12002802|NCT00569491|Device|TAXUS Express 2™|TAXUS Express™ Paclitaxel-Eluting Coronary Stent System
12002803|NCT00569478|Other|rehabilitation|Nursing consultations and physical training
12002804|NCT00569465|Drug|Arginine|1200 mg, once a day
12002805|NCT00569465|Drug|Acetylcysteine|600 mg twice a day
12002806|NCT00569465|Drug|Placebo|3 vials a day
12002807|NCT00569452|Device|Accu-Chek Spirit Insulin Pump|One basal rate
12002808|NCT00569452|Device|Accu-Chek Spirit Insulin Pump|Multiple basal rates
12002809|NCT00569439|Drug|D5NS|5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
12002810|NCT00569439|Drug|D10NS|10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
12002811|NCT00569439|Drug|NS|Normal Saline solution at 125 cc/hr
12002812|NCT00569426|Device|NovoFine® needle 6 mm|
12002813|NCT00569426|Device|NovoFine® needle 8 mm|
12002814|NCT00569400|Drug|human insulin|
12002815|NCT00569387|Biological|HyperAcute(R)-Pancreatic Cancer Vaccine|100 million vaccine cells will be injected intradermally for up to 14 vaccinations over approximately 8 months
12002816|NCT00569374|Drug|Modafinil|subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
12002817|NCT00569361|Procedure|Collection of nasal epithelial cells|Collection of nasal epithelial cells by brushing
12002818|NCT00569335|Drug|S-1, Irinotecan, Bevacizumab|"S-1 is administered orally on days 1 to 14 of a 21-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
~Irinotecan 150 mg/m2 is administered by intravenous infusion on day 1. Bevacizumab 7.5 mg/kg (body weight) is administered by intravenous infusion on day 1."
12002819|NCT00569322|Procedure|BG Test|
12002820|NCT00569309|Biological|Streptococcus pneumoniae|Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
12002821|NCT00569309|Other|laboratory correlative studies|Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
12002822|NCT00569309|Other|quality-of-life assessment|Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. This should take each patient approximately 10-15 minutes to fill out all these surveys per instance.
12002823|NCT00569296|Biological|EGFRBi-armed autologous activated T cells|Dose escalation, dosage depends on when entered in study. 8 infusions (twice a week over 4 weeks. Each infusion will be over at least 1 hour.
12002824|NCT00569296|Biological|aldesleukin|300,00IU/m2/day beginning 3 days before the first Activated T-cell infusion and ending 1 week after the last infusion
12002825|NCT00569296|Biological|sargramostim|250 micrograms/m2/twice weekly beginning 3 days before the first activated T-cell infusion and ending 1 week after the last Activated T-cell infusion
12002826|NCT00569283|Biological|therapeutic allogeneic lymphocytes|
12002827|NCT00569270|Drug|Placebo|Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation
12002828|NCT00569257|Drug|AEZS-108|intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles
12002829|NCT00569244|Drug|Drug: YAZ flex (SH T00186D)|Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
12002830|NCT00569244|Drug|YAZ (SH T00186D)|YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))
12002831|NCT00569231|Drug|Candida Antigen|Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
12002832|NCT00569192|Drug|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
12002833|NCT00569192|Drug|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
12002834|NCT00569192|Drug|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
12002835|NCT00569179|Device|CliniMACS CD34 Reagent System|Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.
12002836|NCT00569166|Behavioral|Paced breathing (15 min once daily, 6 breaths/min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
12002837|NCT00569166|Behavioral|Paced breathing (15 min twice daily, 6 breaths/min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
12002838|NCT00569166|Behavioral|Paced breathing (10 min once daily, 14 breaths/min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.
12002839|NCT00569153|Drug|TAK-700|"Phase 1 portion of study:
~TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.
~Phase 2 portion of study:
~Patients will receive one of 4 treatments:
~TAK-700 at 300 mg twice/day
~TAK-700 at 400 mg and 5 mg prednisone twice/day
~TAK-700 at 600 mg and 5 mg prednisone twice/day
~TAK-700 at 600 mg once/day in the morning"
12002840|NCT00569140|Drug|E10030|Intravitreal injection
12002841|NCT00569127|Biological|Bevacizumab|Given IV
12002842|NCT00569127|Other|Laboratory Biomarker Analysis|Correlative studies
12002843|NCT00569127|Drug|Octreotide Acetate|Given IM
12002844|NCT00569127|Biological|Recombinant Interferon Alfa-2b|Given SC
12002845|NCT00569114|Drug|TG01|Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD
12002846|NCT00569101|Drug|tacrolimus|during the first 2 months : tacrolimus 0.1 mg/kg + prednisolone 0.8 mg/kg p.o. ,then after : tacrolimus 0.1 mg ~0.02 mg/kg + prednisolone tapering
12002847|NCT00569088|Drug|Chinese herbs formula|"The chinese herbs formula includes eight herbs,and they are Radix et Rhizoma Rhei Palmati(Rhubarb,10 grams),Cornu Bubali(Buffalo Horn,30 grams),Radix Paeoniae Bubra(Red Peony Root,15 grams),Cortex Moutan Radicis(Tree Peony Root-bark,10 grams),Radix Rehmanniae(Adhesive Rehmannia Root Tuber,20 grams),Pheretima Aspergillum(Earth-worm,10 grams),Radix Notoginseng(Sanchi,5 grams)and Rhizoma Acori Tarainowii(Tararinow Sweetflag Rhizome,10 grams).
~Boiled together. 150ml of the juice,p.o.,twice a day,for 28 days"
12002848|NCT00569088|Drug|Mannitol|250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days
12002849|NCT00569075|Other|collection of gingival crevicular fluid|GCF samples will be collected at 3 month intervals
12002850|NCT00569062|Drug|GW856553X|GW856553X 7.5mg BID for 6 weeks
12002851|NCT00569062|Other|Placebo|Placebo to match GW856553X
12002852|NCT00569049|Procedure|breast tissue, lymph node tissue or blood|Molecular Analyses of samples
12002853|NCT00569036|Drug|BMS-754807|Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request
12002854|NCT00569023|Dietary Supplement|alga Dunaliella bardawil|"Each patients will be treated with four capsules daily of Dunaliella bardawil for 90 days.
~Alga Dunaliella bardawil containing 15 mg approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers"
12002855|NCT00569010|Drug|Azacitidine|Group 1 and 3 at Level 0 = 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
12002856|NCT00569010|Drug|Ara-C|"Group 1 and 2 at Low-Dose = 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days
~Arms 3 and 4 at High-dose = 1 g/m^2 Daily CIV for 4 days (age<65 years) or 3 days (age>=65 years)"
12002857|NCT00568997|Drug|Pimecrolimus|Pimecrolimus 1% cream
12002858|NCT00568984|Drug|repaglinide|
12002859|NCT00568984|Drug|metformin|
12002860|NCT00568984|Drug|glicazide|
12002861|NCT00568971|Drug|Docetaxel, Cisplatin, 5-Fu|Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
12002862|NCT00568958|Behavioral|BASICS counseling|Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
12002863|NCT00568958|Drug|naltrexone|Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks.
12002864|NCT00568958|Drug|placebo naltrexone|Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.
12002865|NCT00568945|Drug|Capadenoson (BAY68-4986)|4 mg BAY68-4986 for five days
12002866|NCT00568893|Drug|drotrecogin alfa (activated)|
12002867|NCT00568880|Drug|bortezomib|bortezomib 1.0-1.3mg/m2 IV
12002868|NCT00568880|Drug|hydroxychloroquine|hydroxychloroquine 200 mg pill
12002869|NCT00568854|Biological|BCG|Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
12002870|NCT00568841|Drug|erlotinib|erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
12002871|NCT00568841|Procedure|FDG-/FLT-PET|
12002872|NCT00568815|Drug|Rituximab combined with ESHAP|Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5
12002873|NCT00568802|Drug|Hydroxyurea|
12002874|NCT00568802|Drug|Placebo to match hydroxyurea|
12002875|NCT00568789|Drug|Ramelteon, zolpidem and placebo|"Ramelteon 8 mg, tablets, orally, one night only during Period 1, 2 or 3
~Zolpidem 10 mg, tablets, orally, one night only during Period 1, 2 or 3
~Ramelteon/Zolpidem placebo-matching tablets, orally one night only during Period 1, 2 or 3"
12002876|NCT00568776|Drug|Placebo Control|ELND005 matched placebo capsules for oral administration, bid for 78 weeks
12002877|NCT00568776|Drug|ELND005|ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
12002878|NCT00568776|Drug|ELND005|ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
12002879|NCT00568776|Drug|ELND005|ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
12002880|NCT00568763|Biological|sargramostim|
12002881|NCT00568763|Other|immunoenzyme technique|
12002882|NCT00568763|Other|immunohistochemistry staining method|
12002883|NCT00568763|Other|immunologic technique|
12002884|NCT00568763|Other|laboratory biomarker analysis|
12002885|NCT00568763|Procedure|biopsy|
12002886|NCT00568763|Procedure|cryosurgery|
12002887|NCT00568763|Procedure|radiofrequency ablation|
12002888|NCT00568750|Drug|dasatinib|Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).
12002889|NCT00568737|Drug|Drotrecogin alfa (activated)|Drotrecogin Alfa (activated)
12002890|NCT00568737|Drug|Placebo|0.9% sodium chloride
12002891|NCT00568711|Drug|doxycycline|a 5-day course of 100 mg bid doses of doxycycline
12002892|NCT00568711|Drug|rifampin|a 5-day course of daily 600-mg doses of rifampin
12002893|NCT00568698|Drug|Hydroxyurea|
12002894|NCT00568698|Drug|Placebo to match hydroxyurea|
12002895|NCT00568685|Drug|Atomoxetine Hydrochloride|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
12002896|NCT00568685|Drug|Atomoxetine hydrochloride|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
12002897|NCT00568685|Drug|Atomoxetine hydrochloride|"Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days.
~Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days"
12002898|NCT00568672|Drug|Olanzapine|Olanzapine 5 mg / day for 6 months
12002899|NCT00568659|Procedure|specific elastance|The investigators study the specific lung elastance in ALI/ARDS patients in supine and prone position.
12002900|NCT00568646|Drug|MKC-1|Oral MKC-1 capsules, administered twice daily, for 14 consecutive days, in a 28-day cycles
12002901|NCT00568633|Procedure|Allogeneic HSCT|Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.
12002902|NCT00568633|Drug|Anti-thymocyte globulin (ATG)|1.5 mg/kg for 5 days by IV
12002903|NCT00568633|Drug|Cyclosporine (CSP)|6.25 mg/kg twice daily oral
12002904|NCT00568633|Drug|Mycophenolate mofetil (MMF)|15 mg/kg twice daily oral
12002905|NCT00568633|Radiation|Total lymphoid irradiation (TLI)|80 cGy/fraction radiotherapy in 10 fractions.
12002906|NCT00568633|Drug|Methylprednisolone sodium succinate|1.0 mg/kg for 5 days by IV
12002907|NCT00568633|Drug|Best standard care|"Intervention consist of:
~Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
~Autologous transplantation
~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
~Umbilical cord blood transplantation
~Haploidentical transplantation"
12003067|NCT00567489|Drug|Extraneal|7.5% Icodextrin
12003068|NCT00567489|Drug|Nutrineal|Amino Acids 1.1%
12004162|NCT00559676|Other|pharmacological study|
12002908|NCT00568620|Procedure|Placement of nasogastric feeding tube|"Glucose tolerance test via nasogastric feeding tube
~50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3"
12002909|NCT00568620|Procedure|Nasojejunal feeding tube|"Glucose tolerance test via nasojejunal feeding tube
~50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3"
12002910|NCT00568607|Drug|IFO, VP-16, DDP, DXM|DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 75 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.
12002911|NCT00568594|Drug|APL180|
12002912|NCT00568594|Drug|Placebo|
12002913|NCT00568568|Drug|Growth hormone|GH infusion from 8.00 pm to 03.00 am (dose 10,2 ng/kg/min) c) GH infusion from 02.00 am to 09.00 am (dose 10,2 ng/kg/min).
12002914|NCT00568555|Drug|Low Dose Naltrexone|3-4.5mg Naltrexone once daily
12002915|NCT00568555|Drug|Placebo - sugar pill|Placebo pill once daily
12002916|NCT00568542|Drug|erythropoetin beta|35 I.E. kg body weight subcutaneous once per week for 6 months
12002917|NCT00568542|Drug|placebo|35 I.E. kg body weight placebo to erythropoetin beta
12002918|NCT00568529|Drug|Capecitabine and Oxaliplatin|Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w
12002919|NCT00568516|Drug|ASP3550|subcutaneous administration
12002920|NCT00568503|Drug|QAX028|
12002921|NCT00568503|Drug|Placebo|
12002922|NCT00568503|Drug|Tiotropium bromide|
12002923|NCT00568503|Drug|QAX028|
12002924|NCT00568503|Drug|QAX028|
12002925|NCT00568490|Procedure|Tumor biopsy|For patients who undergo tumor biopsy or resection at Stanford, approximately 500 mg of the tumor will be removed from the resection specimen
12002926|NCT00568490|Procedure|Phlebotomy|Blood draw (approximately 20 cc) prior to any anticancer therapy Weekly blood draw (approximately 20cc) only for patients who are undergoing radiation treatment at Stanford University
12002927|NCT00568477|Drug|MabThera|"Rituximab (MabThera):
~375 mg/m² as IV infusions over >=6h each at time point 0 and 2 weeks. Initial infusion rate of 50 mg/h, stepwise rise is possible after 30 minutes"
12002928|NCT00568464|Drug|VCR, CTX, ADM; IFO, VP-16|VCD: VCR 2 mg d1, CTX 1200 mg/m2 d1, Mesna 240 mg/m2 tid d1, ADM 75mg/m2 d1, G-CSF 300 ug/d d5-11; IE: IFO 1800mg/m2 d1-5,Mesna 360 mg/m2 tid d1-5,VP-16 100 mg/m2 d1-5,G-CSF 300 ug/d d6-12; q3w. Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.
12002929|NCT00568451|Drug|carboplatin|AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
12002930|NCT00568451|Drug|paclitaxel|100mg/m^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
12002931|NCT00568451|Drug|temozolomide|150mg/m^2 at cycle 1, 200mg/m^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks
12002932|NCT00568412|Device|Zarzenda|Topical cream, applied twice daily for three weeks
12002933|NCT00568412|Drug|Elidel|1% cream, applied topically twice daily for three weeks
12002934|NCT00568399|Drug|sodium thiosulfate|sodium thiosulfate 12.5-25 gm/M2 after each thrice weekly hemodialysis treatments for 5 months.
12002935|NCT00568386|Other|Systane Lubricant Eye Drops|Systane Lubricant Eye Drops 1 drop each eye once time
12002936|NCT00568386|Other|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops 1 drop each eye one time
12002937|NCT00568373|Device|Enterra Gastric Pacemaker|Gastric Pacemaker
12002938|NCT00568360|Device|Oximeter|
12002939|NCT00568347|Drug|fluticasone 100mcg/ salmeterol 50mcg|inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
12002940|NCT00568347|Drug|fluticasone 250/salmeterol 50|inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide
12002941|NCT00568347|Drug|salmeterol|salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide
12002942|NCT00568347|Drug|Salmeterol|salmeterol 50mcg bid X 3months
12002943|NCT00568347|Drug|salmeterol and fluticasone propionate|salmeterol 50mcg/fluticasone 250mcg by DPI bid
12002944|NCT00568334|Biological|Varilrix (inactivated varicella vaccine)|subcutaneously injection
12002945|NCT00568321|Drug|RN624|50 mcg/kg
12002946|NCT00568321|Drug|RN624|200 mcg/kg
12002947|NCT00568321|Drug|Placebo|placebo
12002948|NCT00568308|Drug|PI-88|160mg subcutaneous injection
12002949|NCT00568308|Drug|placebo|matched placebo
12002950|NCT00568295|Drug|acetaminophen|Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
12002951|NCT00568295|Drug|Rofecoxib|Rofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
12002952|NCT00568295|Drug|Rofecoxib|Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
12002953|NCT00568282|Procedure|phlebotomy|Standard of care
12002954|NCT00568269|Procedure|Open repair|Open repair is according to the Lichtenstein technique
12002955|NCT00568269|Procedure|Laparoscopic repair|The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair
12002956|NCT00568256|Behavioral|Mind/Body Courses|8-week Mind/Body course held once a week for 2 hours at a time.
12002957|NCT00568230|Device|PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant|Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.
12005050|NCT00553215|Procedure|questionnaire administration|
12002958|NCT00568217|Drug|Diclofenac, Paracetamol, Ibuprofen|Immediately if temperature > 38 degree Celsius, diclofenac suppository 1,5 mg/kg once or placebo suppository After eight hours, if temperature still < 38 degree Celsius, acetaminophen mixture 15 mg/kg up to four times a day, or ibuprofen mixture 10 mg/kg up to four times a day, or placebo mixture up to four times a day as long as temperature < 38 degree Celsius
12002959|NCT00568204|Device|Mexyn-A|Atomised topical self-chilled pressurised spray
12002960|NCT00568178|Drug|Losartan Potassium|"Losartan Use During the Double-Blind Treatment Phase:
~Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed <50 kg)
~or 100 mg/day (if the patient weighed ≥50 kg).
~Losartan Use During the Treatment Extension Phase:
~Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance."
12002961|NCT00568178|Other|Comparator: Placebo (Losartan)|Placebo (losartan suspension), administered orally, once daily for 12 weeks
12002962|NCT00568178|Drug|Comparator: amlodipine besylate|Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks
12002963|NCT00568178|Other|Comparator: Placebo (amlodipine besylate)|Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks
12002964|NCT00568178|Other|Placebo (Losartan)|Normotensive patients randomized to losartan placebo for 12 weeks.
12002965|NCT00568178|Drug|Enalapril Maleate|Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.
12002966|NCT00568165|Procedure|Mobile team|a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward
12002967|NCT00568165|Procedure|Standard care|Standard care
12002968|NCT00568152|Dietary Supplement|Low PA apple puree|Golden Delicious apple puree 230grams consumed daily for 14 days
12002969|NCT00568152|Dietary Supplement|High PA apple puree|High PA apple puree (Mitchalin) consumed daily for 14 days
12002970|NCT00568152|Drug|Aspirin|75mg dispersable aspirin taken daily for 14 days
12002971|NCT00568126|Drug|Maca Root|3g/day of Maca Root for 12 weeks.
12002972|NCT00568126|Drug|Placebo|Placebo provided by research pharmacy daily for 12 weeks.
12002973|NCT00568113|Drug|acetylcysteine in arm 1|"Arm 2, control group: given hydroxyl progesterone caproate (150mgm) every 3 days starting from the 28th week of pregnancy till completed 36 weeks of gestation.
~Arm 1 patients were given hydroxyl progesterone caproate (150mgm) weekly injections plus NAC 0.6 gm (Sedico, Egypt) orally daily starting from the 28th week of pregnancy till delivery or completed 36th week of pregnancy."
12002974|NCT00568100|Procedure|PSV and NAVA|evaluated the effect of PSV and NAVA on breathing pattern, respiratory effort, gas exchange and level of breathing comfort in COPD patients
12002975|NCT00568087|Drug|N-acetylcysteine|Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.
12002976|NCT00568087|Drug|Placebo|Patients will take oral placebo (identical matching placebo) during the study period.
12002977|NCT00568074|Drug|repaglinide|
12002978|NCT00568074|Drug|Glurenorm®|
12002979|NCT00568074|Drug|Glucobay®|
12002980|NCT00568061|Drug|Nitric Oxide|Nitric oxide for inhalation
12002981|NCT00568061|Drug|Placebo|Nitrogen gas (placebo) for inhalation
12002982|NCT00568048|Biological|bevacizumab|10 mg/kg i.v., on day 1 of every cycle (14 days) until PD or any other event qualifying for stopping treatment
12002983|NCT00568048|Drug|temozolomide|150 mg/m2 p.o., on days 1-7 of every cycle (14 days) until PD or any other event qualifying for stopping treatment
12002984|NCT00568035|Drug|QR-333|QR-333 or placebo will be applied three times a day for 12 weeks
12002985|NCT00568022|Drug|Ixabepilone|Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles
12002986|NCT00568022|Drug|Capecitabine|Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles
12002987|NCT00568009|Drug|SLV320|1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days
12002988|NCT00567996|Drug|Indacaterol 150 μg|Indacaterol 150 μg once daily (o.d) inhaled
12002989|NCT00567996|Drug|Salmeterol 50 μg|Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
12002990|NCT00567996|Drug|Placebo to Indacaterol|Placebo to Indacaterol inhaled via SDDPI.
12002991|NCT00567996|Drug|Placebo to Salmeterol|Placebo to salmeterol delivered via a proprietary dry powder inhaler
12002992|NCT00567983|Drug|Restasis|Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
12002993|NCT00567983|Drug|Endura|Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
12002994|NCT00567970|Procedure|quality-of-life assessment|
12002995|NCT00567970|Radiation|stereotactic body radiation therapy|
12002996|NCT00567957|Drug|Remifentanil|1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion
12002997|NCT00567957|Drug|Saline|same volume iv bolus before induction followed by same volume infusion
12002998|NCT00567944|Device|BrainPort Balance Device|The BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue.
12002999|NCT00567931|Drug|1-methyl-d-tryptophan|Given orally
12003000|NCT00567931|Other|pharmacological study|Correlative studies
12003001|NCT00567931|Other|laboratory biomarker analysis|Correlative studies
12003002|NCT00567918|Drug|FK506|Ophthalmic suspension
12003003|NCT00567905|Dietary Supplement|Green tea extract|main content is epigallocatechin gallate (EGCG, 58%)
12003069|NCT00567476|Drug|Omalizumab|Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE.
12005051|NCT00553202|Biological|anti-thymocyte globulin|Given IV
12003004|NCT00567892|Device|rTMS|"Stimulation Settings:
~Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains)"
12003005|NCT00567879|Drug|Panobinostat|Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly.
12003006|NCT00567879|Drug|Trastuzumab|Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.
12003007|NCT00567866|Drug|Quetiapine|50 or 100 mg of quetiapine orally
12003008|NCT00567853|Device|Implantation of the MEMO 3D Annuloplasty Ring|Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.
12003009|NCT00567840|Drug|PA-824|200 mg, 600 mg, 100 mg, 1200 mg qd
12003010|NCT00567814|Drug|Metyrapone|Twice daily
12003011|NCT00567814|Drug|Oxazepam|Twice Daily
12003012|NCT00567814|Drug|Placebo|Twice daily
12003013|NCT00567801|Procedure|conventional embolectomy/thrombectomy|
12003014|NCT00567801|Procedure|embolectomy/thrombectomy with controlled reperfusion|
12003015|NCT00567788|Drug|Latanoprost-Bimatoprost|latanoprost 0.005% once daily followed by bimatoprost 0.03%
12003016|NCT00567788|Drug|Bimatoporost-Latanoprost|bimatoprost 0.03% once daily followed by latanoprost 0.005%
12003017|NCT00567775|Drug|human insulin|
12003018|NCT00567775|Drug|inhaled human insulin|
12003019|NCT00567762|Drug|FK506|Opthalmic suspension
12003020|NCT00567762|Drug|placebo|placebo eye drops
12003021|NCT00567736|Drug|Disci/Rhus toxicodendron comp.®|s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
12003022|NCT00567736|Drug|placebo solution|s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
12003023|NCT00567710|Drug|BL - 1020|10 mg/day
12003024|NCT00567710|Drug|BL - 1020|BL 1020 20-30 mg/day
12003025|NCT00567710|Drug|Placebo|Capsules
12003026|NCT00567710|Drug|Risperidone|Capsules
12003027|NCT00567697|Drug|ranibizumab|0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.
12003028|NCT00567697|Drug|ranibizumab|Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.
12003029|NCT00567684|Device|Computed Tomography Urography (CTU)|CTU performed at least a day before or after the IVU procedure.
12003030|NCT00567684|Other|Intravenous Urography (IVU)|A routine IVU procedure performed prior to or after CTU.
12003031|NCT00567671|Procedure|Corneal collagen|Corneal collagen cross-linking with riboflavin/UVA light
12003032|NCT00567671|Procedure|Sham comparator|Sham treatment
12003033|NCT00567658|Drug|Esomeprazole|Esomeprazole or Nexium 40 mg BID is given for four months.
12003034|NCT00567606|Other|risedronate, calcium/vit D, strength weight training|G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine. G2 group receives the calcium, vitamin D, and risedronate, but do not participate in strength/weight training exercises.
12003035|NCT00567593|Drug|Rosiglitazone|8mg tablet once a day for 14 days
12003036|NCT00567580|Drug|bicalutamide|Oral, daily
12003037|NCT00567580|Drug|flutamide|Oral, daily
12003038|NCT00567580|Radiation|radiation therapy|Once daily, 5 days a week
12003039|NCT00567567|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
12003040|NCT00567567|Drug|Carboplatin|Given IV
12003041|NCT00567567|Drug|Cisplatin|Given IV
12003042|NCT00567567|Drug|Cyclophosphamide|Given IV
12003043|NCT00567567|Drug|Doxorubicin Hydrochloride|Given IV
12003044|NCT00567567|Drug|Etoposide|Given IV
12003045|NCT00567567|Radiation|External Beam Radiation Therapy|Undergo EBRT
12003046|NCT00567567|Biological|Filgrastim|Given IV or SC
12003047|NCT00567567|Drug|Isotretinoin|Given orally
12003048|NCT00567567|Other|Laboratory Biomarker Analysis|Correlative studies
12003049|NCT00567567|Drug|Melphalan|Given IV
12003050|NCT00567567|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
12003051|NCT00567567|Other|Pharmacological Study|Correlative studies
12003052|NCT00567567|Drug|Thiotepa|Given IV
12003053|NCT00567567|Drug|Topotecan Hydrochloride|Given IV
12003054|NCT00567567|Drug|Vincristine Sulfate Liposome|Given IV
12003055|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel|
12003056|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel + bevacizumab|
12003057|NCT00567554|Drug|paclitaxel|
12003058|NCT00567554|Drug|paclitaxel + everolimus (RAD001)|
12003059|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel + trastuzumab|
12003060|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel + lapatinib|
12003061|NCT00567541|Device|Battery Powered Microneuromodulator (BBPM)|The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo).
12003062|NCT00567528|Drug|Ibuprofen|Apply by rubbing into skin for 30 to 60 seconds placebo ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking active capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
12003063|NCT00567528|Drug|ibuprofen|Apply by rubbing into skin for 30 to 60 seconds active ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking placebo capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
12003064|NCT00567515|Device|AtriCure LAA Exclusion System|Placement of clip of LAA.
12003065|NCT00567489|Drug|Physioneal|Physioneal 40 or Physioneal 35
12003070|NCT00567476|Drug|Inhaled corticosteroids (ICS)|Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent
12003071|NCT00567476|Drug|Long-acting beta 2-adrenergic agonist (LABA)|Fixed dose of LABA as prescribed prior to study entry
12003072|NCT00567476|Drug|Short-acting beta 2-adrenergic agonist (SABA)|Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.
12003073|NCT00567463|Device|Fluticasone|Fluticasone 250mcg for 3 months followed by 100mcg for 9 months, one puff once a day at supper time
12003074|NCT00567450|Drug|ropivacaine|30ml of a mixture of ropivacaïne 0.75%
12003075|NCT00567450|Drug|ropivacaine plus mepivacaine|30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
12003076|NCT00567437|Other|NT-pro-BNP levels|pre- and post-exercise NT-pro-BNP levels
12003077|NCT00567424|Drug|GW273225|
12003078|NCT00567411|Drug|brimonidine 0.1%|1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)
12003079|NCT00567411|Drug|Apraclonidine 0.5%|1 drop applied 1 hour prior to SLT
12003080|NCT00567398|Drug|Dianeal|Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)
12003081|NCT00567398|Drug|Physioneal|Physioneal 40 or Physioneal 35
12003082|NCT00567398|Drug|Extraneal|Extraneal - 7.5% Icodextrin
12003083|NCT00567398|Drug|Nutrineal|Nutrineal - 1.1% Amino Acids
12003084|NCT00567385|Drug|somatropin|
12003085|NCT00567372|Drug|bevacizumab (Sub-tenon´s injection)|a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)
12003086|NCT00567359|Drug|Erlotinib|Oral drug taken daily around the same time. Starting dose is 150mg once daily.
12003087|NCT00567346|Drug|Oralgen|Patients will receive drops of grass pollen immunotherapy sublingually
12003088|NCT00567346|Drug|grass pollen extract|Patients will receive matching placebo sublingually
12003089|NCT00567333|Other|Chiropractic care|A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education.
12003090|NCT00567333|Other|Multidisciplinary, integrative care|A combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy.
12003091|NCT00567320|Drug|Varenicline|Varenicline up to 2 mg a day
12003092|NCT00567320|Drug|Sugar pill or Placebo|Placebo
12003093|NCT00567307|Drug|Red Heart Pill 2b (Polypill)|Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
12003094|NCT00567307|Other|Standard Practice|Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions
12003095|NCT00567294|Behavioral|Mailed education|Mailed education materials on osteoporosis and medication use over a 1-year period
12003096|NCT00567294|Behavioral|Telephone coaching program for patients|A telephone coaching program that will involve twelve monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely.
12003097|NCT00567294|Behavioral|Medication adherence alert program for doctors|Doctors of participants will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among people with osteoporosis. Doctors will also receive alerts on any patients who are not filling their medication prescriptions.
12003098|NCT00567281|Device|Magstim Rapid 2 system triggering Magstim Super Rapid system|Week 1 treatment includes rTMS for 5 sessions to either to left or right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
12003099|NCT00567281|Device|Magstim Rapid-2 system triggering Magstim Super Rapid system|Week 1 includes repetitive rTMS for 5 sessions to either to left or right Wernicke's area (BA22) synchronous with sham rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, sham rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
12003100|NCT00567268|Drug|Gabapentin|"GABAPEN Tablets 200mg, GABAPEN Tablets 300mg, GABAPEN Tablets 400mg. GABAPEN is Brand name in Japan.
~Dosage, frequency: According to Japanese LPD, Normally, oral gabapentin 600 mg, 3 div., should be given on the first day of administration and an effective dose of 1200mg, 3 div, should be given on day 2. From day 3 on, adults should be maintained on oral gabapentin 1200 mg to 1800 mg, 3 div. Subsequently, the maintenance dose should be suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
~Duration: According to the protocol of A9451163, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 12 weeks after the first administration."
12003101|NCT00567255|Drug|Naltrexone SR 32 mg/bupropion SR 360 mg/day|
12003102|NCT00567255|Drug|Placebo|
12003103|NCT00567255|Behavioral|Ancillary therapy|Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
12003148|NCT00566917|Procedure|Anterior colporrhaphy|Standardised colporrhaphy of the anterior vaginal wall
12005052|NCT00553202|Drug|busulfan|Given IV
12003104|NCT00567242|Behavioral|Word-finding with intention component|Word-finding trials (picture-naming) with intention manipulation (initiating word-finding trials with a complex left-hand movement). 8 (or more) baseline sessions over 4 days followed by 30 treatment sessions (2 sessions/day, 5 days/week for 3 weeks).
12003105|NCT00567242|Behavioral|Word-finding with no intention component|Word-finding trials with no intention manipulation. 8 (or more) baseline sessions in 4 days followed by 30 treatment sessions (2 sessions/day, 5 days/week for 3 weeks).
12003106|NCT00567229|Biological|rituximab|
12003107|NCT00567229|Drug|lenalidomide|
12003108|NCT00567229|Genetic|microarray analysis|
12003109|NCT00567229|Other|flow cytometry|
12003110|NCT00567229|Other|laboratory biomarker analysis|
12003111|NCT00567216|Drug|Nadolol|Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
12003112|NCT00567203|Drug|PF-3463275|PF-3463275 10mg
12003113|NCT00567203|Drug|PF-3463275|PF-3463275 25mg
12003114|NCT00567203|Drug|Placebo|Placebo
12003115|NCT00567190|Drug|Pertuzumab|Pertuzumab was administered as an intravenous (IV) loading dose of 840 milligrams (mg) q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420 mg q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
12003116|NCT00567190|Drug|Placebo|Placebo (matching pertuzumab) was administered intravenously.
12003117|NCT00567190|Drug|Trastuzumab|Trastuzumab was administered as an IV loading dose of 8 milligrams per kilogram (mg/kg) q3w on Day 2 of Cycle 1 (1 Cycle length = 21 days), and 6 mg/kg q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
12003118|NCT00567190|Drug|Docetaxel|Docetaxel was administered as an IV dose of 75 milligrams per square meter of body surface area (mg/m^2) q3w on Day 2 of Cycle 1 (1 Cycle length = 21 days), and 75 mg/m^2 (up to 100 mg/m^2 as per treating physician discretion) q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. On or prior to Cycle 6, docetaxel was only to be discontinued for progressive disease or unmanageable toxicity. After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician.
12003119|NCT00567177|Drug|Restasis, Refresh Plus|Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening
12003120|NCT00567164|Drug|EE20/DRSP (BAY86-5300)|Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
12003121|NCT00567164|Drug|EE20/DRSP (BAY86-5300)|Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
12003122|NCT00567164|Drug|EE20/DRSP (YAZ, BAY86-5300)|Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
12003123|NCT00567112|Drug|10 mg MK-0941 DFC (fasted)|single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state
12003124|NCT00567112|Drug|10 mg MK-0941 OCT (after meal)|single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal
12003125|NCT00567112|Drug|10 mg MK-0941 OCT (before meal)|single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast
12003126|NCT00567112|Drug|10 mg MK-0941 OCT (fasted)|single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state
12003127|NCT00567099|Drug|Aripiprzole|"Dosage form, dosage, frequency and duration:
~Aripiprazole 5-30 mg tabs po qday x 3 months"
12003128|NCT00567086|Drug|TEZAMPANEL|Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
12003129|NCT00567073|Biological|alglucosidase alpha|
12003130|NCT00567073|Other|No Treatment|
12003131|NCT00567060|Drug|Piracetam|
12003132|NCT00567047|Drug|vildagliptin|
12003133|NCT00567034|Drug|naltrexone|50mg naltrexone, 1 tablet a day for 12 weeks.
12003134|NCT00567034|Drug|placebo|lactose placebo, 1 capsule every day for 12 weeks
12003135|NCT00567008|Drug|varenicline|1.0 mg BID for 8 weeks
12003136|NCT00567008|Drug|placebo|placebo BID for 8 weeks
12003137|NCT00566995|Drug|ZACTIMA (Vandetanib) (ZD6474)|
12003138|NCT00566982|Drug|Ospemifene 60 mg|60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.
12003139|NCT00566982|Drug|Placebo|Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)
12003140|NCT00566969|Drug|sugar pill|Subjects randomized to placebo, carvedilol 25mg or 50mg
12003141|NCT00566969|Drug|Carvedilol 25 mg|subjects randomized to placebo, carvedilol 25mg or 50mg
12003142|NCT00566969|Drug|Carvedilol 50 mg|subjects randomized to placebo, carvedilol 25mg or 50mg
12003143|NCT00566956|Procedure|Hydrosalpinx needle aspiration to arm 1|For those assigned to Group I, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. The hydrosalpinx fluid is discarded
12003144|NCT00566943|Device|PSD Veritas Collagen Matrix|Roux-en-Y gastric by-pass surgery. Surgeon creates a small pouch from the stomach and then by-passes a large portion of the small intestine. The body cannot absorb as many calories or nutrients thus resulting in weight loss.
12003145|NCT00566943|Procedure|Roux-en-Y gastric by-pass surgery with no buttress|Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple line including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine intestine to mesentery.
12003146|NCT00566930|Other|spinal manipulation|Monthly cervical spinal manipulation
12003147|NCT00566930|Other|Spinal manipulation + exercises|Monthly cervical spine manipulation and daily home exercises
12003150|NCT00566904|Drug|Epikeia coatings with aspirin|Applied to affected skin area using a roll-on ball applicator
12003151|NCT00566904|Drug|Epikeia coatings with lidocaine|Applied to affected skin area using a roll-on ball applicator
12003152|NCT00566904|Other|Epikeia coatings alone|Applied to affected skin area using a roll-on ball applicator
12003153|NCT00566891|Drug|tirofiban|tirofiban high dose bolus 25µ/Kg
12003154|NCT00566891|Drug|Clopidogrel|
12003155|NCT00566878|Biological|alglucosidase alfa|At least one infusion of alglucosidase alfa post partum
12003156|NCT00566865|Drug|placebo for gemfibrozil|mitiglinide + placebo for gemfibrozil 600 mg bid
12003157|NCT00566865|Drug|gemfibrozil|Mitiglinide + 600 mg gemfibrozil bid
12003158|NCT00566852|Drug|Memantine|Patients began taking memantine(by mouth) while receiving radiation therapy. Patients continued taking memantine for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.
12003159|NCT00566852|Other|Placebo|Patients began taking placebo(by mouth) while receiving radiation therapy. Patients continued taking placebo for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.
12003160|NCT00566852|Radiation|Whole brain radiation therapy|Whole brain radiation therapy (WBRT) once a day (2.5Gy), five days a week (Monday to Friday) for three weeks, for total fifteen treatments and 37.5 Gy
12003161|NCT00566839|Procedure|awake nonresectional LVRS|Thoracoscopic nonresectional lung volume reduction surgery carried out in awake patients under sole epidural anesthesia through plication of most emphysematous target areas of the lung
12003162|NCT00566839|Procedure|Nonawake resectional LVRS|Thoracoscopic lung volume reduction surgery carried out under general anesthesia and one-lung ventilation through nonanatomic resection of the most emphysematous target areas of the lung
12003163|NCT00566826|Behavioral|Patient support sessions|Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
12003164|NCT00566826|Behavioral|Treatment as usual|Treatment as usual includes standard care for TKR surgery rehabilitation.
12003165|NCT00566813|Drug|Islet Cell Transplant|1-3 allogeneic islet transplants; two doses of basiliximab 20 mg iv.; sirolimus po trough levels 10-15 ng/ml X 3 months, then 7-10 ng/ml; tacrolimus po trough levels 3-6 ng/ml
12003166|NCT00566813|Drug|Islet Cell Transplant plus|1-3 allogeneic Islets of Langerhans transplantations; two doses of basiliximab 20 mg iv.; sirolimus po daily to maintatin serum levels 12-15 ng/mL for 3 months, and 7-10 ng/mL thereafter; tacrolimus po twice daily to maintain serum levels 3-6 ng/mL; etanercept 50 mg IV before islet transplant, 25 mg subcutaneously post-transplant days 3, 7, 10; exenatide subcutaneously 5 mcg pre-transplant and twice daily for I week, then increased to 10-mcg twice daily for 6 months after the last islet transplant.
12003167|NCT00566800|Drug|erlotinib hydrochloride|
12003168|NCT00566800|Other|laboratory biomarker analysis|
12003169|NCT00566800|Procedure|biopsy|
12003170|NCT00566787|Device|Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System|Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
12003171|NCT00566774|Other|Full drug coverage|Patients randomized to first-dollar coverage will have their pharmacy benefits changed so that they have no out-of-pocket costs for any beta-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) antagonist, or statin for every subsequent prescription after randomization. All co-pays and co-insurance will be waived at the point of care (i.e. pharmacy) as will any contribution that the cost of these drugs contributes to a patient's deductible
12003172|NCT00566774|Other|Usual coverage|Patients randomized to usual coverage will have no change in their existing benefits
12003173|NCT00566761|Drug|bevacizumab and triamcinolone|three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2
12003174|NCT00566735|Drug|Razadyne|The starting dose of study medication is 4 mg twice a day
12003175|NCT00566735|Drug|Placebo|4 mg, 2 times a day
12003176|NCT00566722|Biological|adalimumab|Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
12003177|NCT00566709|Procedure|Red blood cells transfusion|Patients will be transfused (one to one red blood cells unit transfusion)
12003178|NCT00566696|Device|CliniMACS|Miltenyi Biotec CliniMACS stem cell selection device
12003179|NCT00566696|Procedure|Stem cell transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
12003180|NCT00566696|Drug|Fludarabine|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003181|NCT00566696|Drug|Thioplex®|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003182|NCT00566696|Drug|L-phenylalanine mustard|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003183|NCT00566696|Drug|Mycophenolate mofetil|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003184|NCT00566696|Drug|Rituxan™|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003185|NCT00566696|Drug|Alemtuzumab|After January 2010, due to the unavailability of muromonab, transplant recipients received a conditioning regimen consisting of systemic chemotherapy and antibodies, including alemtuzumab.
12003186|NCT00566696|Drug|Cyclophosphamide|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003187|NCT00566696|Drug|Anti-thymocyte globulin (Rabbit)|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003188|NCT00566696|Drug|G-CSF|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
12003268|NCT00566111|Drug|Saline solution|Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
12003269|NCT00566098|Biological|MILs|
12003189|NCT00566696|Drug|Muromonab|Prior to January 2010, transplant participants received a conditioning regimen consisting of systemic chemotherapy and antibodies, including muromonab. Muromonab became unavailable from the manufacturer at that time and was replaced by alemtuzumab.
12003190|NCT00566683|Drug|diazemuls, pethidine|5mg Diazemuls and 25mg Pethidine one min. before procedure followed by bolus doses of 2.5mg Diazemuls / 12.5mg Pethidine at the discretion of endoscopists Maximal dose of 0.2mg/kg Diazemuls and 1mg/kg Pethidine
12003191|NCT00566683|Drug|Propofol and Alfentanil|Loading dose of 40-60mg or 0.8mg/kg Propofol one min. before procedure Propofol 200mg + Alfentanil 0.5mg, 1.5ml per bolus (bolus dose of 14.3mg Propofol + 35ug Alfentanil) via PCA pump No maximal dose Zero lockout time
12003192|NCT00566657|Biological|riferminogene pecaplasmid|"Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid
~Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated"
12003193|NCT00566657|Biological|Placebo (for riferminogene pecaplasmid)|"Formulation: 5 ml glass vials containing 2,5 ml placebo
~Route: IM injection of 2.5 mL in the ischemic leg to be treated"
12003194|NCT00566644|Device|levonorgestrel-releasing intrauterine system|
12003195|NCT00566644|Other|questionnaire administration|
12003196|NCT00566644|Procedure|observation|
12003197|NCT00566631|Drug|Paliperidone|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
12003198|NCT00566618|Drug|Dasatinib|"Phase I: First Cohort = 100 mg PO Daily x 28 days; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort.
~Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I."
12003199|NCT00566618|Drug|Zoledronic Acid|"Phase I: First Cohort = 4 mg IV Over 15 min. every 4 Weeks; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort.
~Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I."
12003200|NCT00566605|Procedure|Penetrating keratoplasty with IntraLase|penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
12003201|NCT00566605|Procedure|Penetrating keratoplasty with vacuum trephine|Group 2 - penetrating keratoplasty with vacuum trephine
12003202|NCT00566592|Other|oral ethanol, overnight|Oral ethanol before bedtime to achieve approximate BAL of 0.08%
12003203|NCT00566592|Other|IV ethanol|IV ethanol before bedtime to achieve approximate BAL of 0.08%
12003204|NCT00566592|Other|soda water|Oral Placebo before bedtime to achieve approximate BAL of 0.00%
12003205|NCT00566592|Other|soda water|Oral Placebo to achieve approximate daytime BAL of 0.00%
12003206|NCT00566579|Procedure|Cryotherapy|Double freezing technique
12003207|NCT00566566|Other|sample without DNA|family history, anthropometric measurements and blood sampling
12003208|NCT00566553|Dietary Supplement|Grape Seed Extract|200 mg dose daily for 12 weeks.
12003209|NCT00566553|Dietary Supplement|Grape Seed Extract|400 mg dose daily for 12 weeks.
12003210|NCT00566553|Dietary Supplement|Grape Seed Extract|600 mg dose daily for 12 weeks.
12003211|NCT00566553|Dietary Supplement|Grape Seed Extract|800 mg dose daily for 12 weeks.
12003212|NCT00566540|Drug|Cisplatin|Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.
12003213|NCT00566540|Drug|Paclitaxel|Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10
12003214|NCT00566540|Radiation|Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation|Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nodes 20Gy over 10 daily (M-F) treatments (2 Gy Fractions with 6 millivolts photons)week 1 and 2.
12003215|NCT00566540|Procedure|Triple endoscopy and biopsy|Resection of the primary tumor: Patients must have surgery performed according to the following surgical guidelines. The extent of the surgical resection will be dictated by the extent of the tumor at the time of initial evaluation. The primary lesion must be widely excised using accepted criteria for adequate excision depending on the region involved. All patients will undergo percutaneous endoscopic gastrostomy tube placement at the time of endoscopy and biopsies.
12003216|NCT00566527|Biological|ProQuad® manufactured with recombinant Human Albumin (rHA)|A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).
12003217|NCT00566514|Dietary Supplement|D-ribose|5 grams administered orally TID
12003218|NCT00566514|Other|dextrose|5 grams orally TID
12003219|NCT00566501|Drug|23 mg SR in Study 326|Patients will receive 23 mg donepezil SR orally, once daily for 12 months.
12003220|NCT00566501|Drug|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
12003221|NCT00566488|Biological|Thymus/Parathyroid Transplantation|Thymus tissue, thymus donor, mother of thymus donor, & parental parathyroid donor screened for transplant safety. Depending on T cell phenotype & function, subjects were given 1 of 2 immunosuppression regimes. All received rabbit anti thymocyte globulin pretransplantation. Others also received cyclosporine pre & post-transplantation. The thymus dose was over 0.2 grams/kg recipient weight. Thymus transplant occurred in operating room; thymic slices were placed in quadriceps. Parathyroid harvest was done under general anesthesia. One parathyroid gland was minced and placed in quadriceps muscle. There was no dose in mg. An open biopsy of thymus allograft was done 2-3 months post-transplant. Biopsy tissue was examined by immunohistochemistry to evaluate for thymopoiesis & graft rejection.
12003222|NCT00566475|Other|telemedicine|School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent
12003223|NCT00566462|Drug|perampanel|2 mg/d for 14 days followed by 4 mg/d for 14 days
12003224|NCT00566462|Drug|placebo|Matching placebo for for 14 days followed by 4 mg/d for 14 days
12003225|NCT00566449|Drug|Placebo|one dose daily for 4 weeks
12003226|NCT00566449|Drug|JNJ-31001074|10 mg daily for 4 weeks
12003227|NCT00566449|Drug|JNJ-31001074|30 mg daily for 4 weeks
12003270|NCT00566098|Drug|Melphalan|
12003228|NCT00566436|Procedure|Remote endarterectomy of the superficial femoral artery|Exposure of the common femoral, superficial femoral and profunda femoral artery through a single groin incision. Arteriotomy in the proximal SFA followed by dissection of the intima core beyond the occluded segment using the Vollmar ringstripper. The ringstripper is exchanged for a Mollring cutter all under fluoroscopic guidance. With the Mollring Cutter transection of intima core is carried out, remote from the site of entry. After removal of the intima core the transection zone is secured with an aSpire stent after balloon angioplasty. A completion arteriography will verify a patent artery, and embolectomy can be performed when necessary. As indicated a common femoral artery and profundaplasty can be performed and the arteriotomy may be closed with or without patch.
12003229|NCT00566436|Procedure|Suprageniculate femoropopliteal bypass|Groin and suprageniculate incision, venous (Saphenous vein) or PTFE graft with end to side anastomoses. If the saphenous vein is truly applicable for grafting will ultimately be an intra-operative decision (despite pre-operative venous mapping)
12003230|NCT00566423|Other|Blood draw|Venous and Arterial Blood draw samples; 6 Minute Walk test
12003231|NCT00566410|Drug|Dichloroacetate|Continuous daily oral dosage (bid).
12003232|NCT00566397|Drug|PF-04494700|15 mg for 6 days followed by daily dosing of 5mg
12003233|NCT00566397|Drug|PF-04494700|60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
12003234|NCT00566397|Drug|Placebo|Placebo
12003235|NCT00566384|Drug|Dehydroepiandrosterone, BAY86-5314|Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
12003236|NCT00566384|Drug|Placebo|Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
12003237|NCT00566371|Drug|atomoxetine|Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.
12003238|NCT00566371|Drug|placebo|placebo
12003239|NCT00566358|Procedure|Duodenal exclusion surgery|Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create an excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
12003240|NCT00566345|Biological|Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)|Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
12003241|NCT00566345|Biological|Phosphate buffered saline|Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
12003242|NCT00566332|Drug|Chlorambucil|Chlorambucil 8 mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months By oral route
12003243|NCT00566332|Drug|Fludarabine|Fludarabine 40 mg/m² (30 mg/m² if patient aged more than 75 years old) 5 days every 28 days during 6 cycles By oral route
12003244|NCT00566319|Behavioral|PREPARE with pedometer|Structured educational programme with pedometer use
12003245|NCT00566319|Behavioral|PREPARE|Structured educational programme
12003246|NCT00566306|Other|Polyhexamethyleneguanidine (PHMG)|6 months in 3 experimental wards
12003247|NCT00566280|Procedure|Molecular Breast Imaging|A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 20 mCi of 99m Tc-sestamibi.
12003248|NCT00566267|Drug|simvastatin 20 mg/ezetimibe|see protocol
12003249|NCT00566254|Drug|Zonisamide|8mg/kg per day for approximately 24 weeks.
12003250|NCT00566254|Drug|Placebo|
12003251|NCT00566241|Drug|recombinant human IGF-1|rhIGF-1
12003252|NCT00566241|Drug|Placebo|Placebo
12003253|NCT00566228|Procedure|autologous hematopoietic stem cell transplantation|Patients undergo autologous stem cell transplantation
12003254|NCT00566228|Procedure|leukapheresis|Stem cells collected
12003255|NCT00566215|Procedure|Duodenal exclusion plus omentectomy|"Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
~Additionally, total omentectomy is performed."
12003256|NCT00566215|Procedure|Duodenal exclusion without omentectomy|Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
12003257|NCT00566202|Drug|Placebo|Form= capsule, route= oral use. Administration once daily for 8 weeks.
12003258|NCT00566202|Drug|Escitalopram|Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 20 mg daily for 6 weeks, and 10 mg daily for 1 week.
12003259|NCT00566202|Drug|JNJ-18038683|Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.
12003260|NCT00566189|Procedure|Roux-en-Y Bypass Gastroplasty|Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch. A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.
12003261|NCT00566176|Device|Surgical Ablation using the AtriCure Bipolar System|Surgical Ablation using the AtriCure Bipolar System
12003262|NCT00566150|Drug|Levetiracetam|Flexible dose up to 2500mg per day, for 6 weeks.
12003263|NCT00566150|Drug|Placebo|Flexible dose up to 2500mg per day, for 6 weeks.
12003264|NCT00566124|Drug|Insulin detemir|0.4 U/kg bw insulin detemir injected s.c. in the thigh.
12003265|NCT00566124|Drug|Insulin glargine|0.4 U/kg bw insulin glargine injected s.c. in the thigh
12003266|NCT00566124|Drug|Insulatard|0.4 U/kg bw NPH insulin injected s.c. in the thigh
12003267|NCT00566111|Drug|ceftriaxone|2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
12003272|NCT00566085|Procedure|Molecular Breast Imaging|A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 28-32 mCi of 99m Tc-sestamibi.
12003273|NCT00566072|Behavioral|instructions and coaching|instructions and coaching or no intervention on the use and intake of ganciclovir
12003274|NCT00566046|Drug|Levetiracetam|1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
12003275|NCT00566046|Drug|Placebo|1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
12003276|NCT00566033|Behavioral|Audit-driven intervention|Patients included in this arm will undergo to the multi-method quality improvement intervention (intensive intervention) that adds practice visits, telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination and feedback on demand used in the less intensive intervention.
12003277|NCT00566020|Drug|BW430C (lamotrigine)|lamotrigine 50mg/day-400mg/day
12003278|NCT00566007|Procedure|Discectomy/ micro discectomy|Standard discectomy or micro discectomy
12003279|NCT00566007|Drug|Ozone therapy|Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
12003280|NCT00566007|Drug|Oxygen therapy|Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
12003281|NCT00565994|Procedure|Blood Draw|For patients undergoing routine hemodialysis for chronic renal failure, 5-10 ml of blood will be removed from the dialysis tubing during vascular access. All other subjects will have 5-10 ml of blood drawn by routine venipuncture.
12003282|NCT00565981|Drug|Fludarabine phosphate|orally, 40 mg/m2 d1-3 q4w, x4 cycles
12003283|NCT00565981|Drug|Alemtuzumab|subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose
12003284|NCT00565968|Drug|melphalan|
12003285|NCT00565968|Drug|sorafenib tosylate|
12003286|NCT00565968|Genetic|gene expression analysis|
12003287|NCT00565968|Genetic|protein expression analysis|
12003288|NCT00565968|Genetic|western blotting|
12003289|NCT00565968|Other|pharmacological study|
12003290|NCT00565955|Drug|montelukast|"Standard case management will be carried out as per guidelines given by British Thoracic Society. All patients will receive montelukast or similar looking placebo tablets. The doses of montelukast will be as follows:
~5-12 years: 5 mg chewable tablet of montelukast; > 12 years: 10 mg chewable tablet of montelukast. Study drug will be administered at time of administration of steroid."
12003291|NCT00565955|Drug|Placebo|The patients will receive placebo tablets.
12003292|NCT00565942|Procedure|Integrative care|In short, integrative care was up to 10 complementary therapy treatments delivered to the patient in addition to the usual care over an intervention period of up to 12 weeks. The integrative care was provided by a multidisciplinary team coordinated by a gate keeping general practitioner with clinical knowledge and experience of CTs and senior licensed/certified CT providers representing Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong.
12003293|NCT00565942|Procedure|Usual care|The usual care treatment was coordinated by the patient's general practitioner and complied with the clinical practice routines at the participating primary care units. Conventional procedures included but were not exclusive to advice, prescription of drugs, sick leave and physiotherapy/physical therapy. There were no constraints to the provided usual care as the study aimed to pragmatically reflect the general practitioners' standard care and treatment as usual.
12003294|NCT00565929|Drug|Placebo|Sterile saline (0.9%).
12003295|NCT00565929|Biological|MVA-BN|The smallpox vaccine is a liquid frozen solution formulated to contain 0.605 mg Tris and 4.090 mg sodium chloride (NaCl) per 0.5 mL dose. The concentration of the virus will be 1 X 10^8 tissue culture infectious dose 50 (TCID 50) per 0.5 mL dose and may be diluted in a solution of 0.9% saline prior to vaccination. Smallpox vaccine administered in 2 doses approximately 28 days apart in one of the following doses: 1X10^7 or 1X10^8 TCID 50.
12003296|NCT00565916|Drug|Estrogen|"Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo.
~Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO)."
12003297|NCT00565916|Drug|Progesterone|Estrogen plus progesterone: estradiol with oral progesterone (Prometrium, 200 mg/day) for 3 days, instead of placebo. Progesterone therapy involves taking a daily oral pill of 200 mg Prometrium for the same 3 days that the estradiol is taken.
12003298|NCT00565916|Drug|Placebo|Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken.
12003299|NCT00565890|Drug|thyroxine|thyroxine at the dose of 5 μg/kg-wt /day
12003300|NCT00565877|Other|Ultrasound inspection|post-PICC insertion Ultrasound inspection of the ipsilateral neck for PICC in a malposition (ipsilateral internal jugular vein)
12003301|NCT00565864|Drug|L-thyroxine (L-T4)|L-thyroxine (L-T4) is the intervention for each arm/group. In each arm/group, the dose of L-T4 is adjusted to achieve TSH levels in the randomly assigned arm. L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
12003302|NCT00565851|Biological|Bevacizumab|Given IV
12003303|NCT00565851|Drug|Carboplatin|Given IV
12003304|NCT00565851|Drug|Docetaxel|Given IV
12003305|NCT00565851|Drug|Gemcitabine Hydrochloride|Given IV
12003306|NCT00565851|Other|Laboratory Biomarker Analysis|Correlative studies
12003307|NCT00565851|Drug|Paclitaxel|Given IV
12003308|NCT00565851|Other|Quality-of-Life Assessment|Ancillary studies
12003309|NCT00565838|Procedure|AFS and TVT|Autologous Fascial Sling and Tension- Free Vaginal Tape
12003310|NCT00565812|Drug|SD-6010|200 mg tablets once a day for 2 years
12003311|NCT00565812|Drug|SD-6010|50 mg tablets once a day for 2 years
12003312|NCT00565812|Drug|Placebo|Placebo tablets once a day for 2 years
12003313|NCT00565799|Procedure|Omentectomy|Removing the omentum
12003314|NCT00565799|Other|No intervention|Only LAGB without Omentectomy
12003315|NCT00565786|Device|ArCom® Polyethylene|Argon packaged compression molded polyethylene
12003316|NCT00565786|Device|ArComXL® Polyethylene|Highly crosslinked Ultra High Molecular Weight Polyethylene
12003317|NCT00565773|Drug|Belatacept|Belatacept will be given within 24 hours of transplantation via a peripheral intravenous catheter at a dose of 10mg/kg (actual body weight) infused over 30 mins. The dose will be repeated on study days 4 (post op day 3) and 8 (post op day 7), then every 2 weeks for 5 additional doses. Thereafter, belatacept will be given once every 4 weeks (+/- 3 days) at 10mg/kg through 6 months then at 5mg/kg indefinitely.
12003318|NCT00565773|Drug|Sirolimus|Sirolimus will be started on postoperative day 1 at a dose of 2 mg per day orally. Doses will be adjusted to maintain 24-hour trough levels of 8-10ng/ml until the drug is weaned. Toxicity attributable to sirolimus (e.g., mouth ulcers, arthralgias) will prompt dose reduction to address clinical concerns in this regard. If sirolimus trough levels need to be reduced below 4ng/ml to control drug side effects, the patient will be considered intolerant to the drug and will be changed to other medications.
12003319|NCT00565773|Drug|Alemtuzumab|All participants will receive a single dose of 30 mgs of alemtuzumab on the day of transplantation.
12003320|NCT00565760|Drug|Q8003|Capsules
12003321|NCT00565760|Drug|Placebo|Capsules
12003322|NCT00565747|Device|Test culture|A standard culture medium with added GM-CSF (ready-to-use)
12003323|NCT00565747|Device|Control culture|The same standard culture medium, but without any additions (ready-to-use)
12003324|NCT00565721|Drug|Fluciclatide Injection - (AH111585 (F18))|18F labelled Cyclic RGD peptide PET agent for injection.
12003325|NCT00565708|Other|placebo|Placebo Comparator
12003326|NCT00565708|Drug|Acetylsalicylic acid|Adjuvant Therapy
12003327|NCT00565695|Device|aspheric ReSTOR multifocal intraocular lens (IOL)|Multifocal intraocular lens
12003328|NCT00565682|Drug|etoricoxib 120 mg|etoricoxib 120 mg, tablet, orally, OD
12003329|NCT00565669|Drug|Cyclosporin A Restasis®|
12003330|NCT00565669|Drug|Blink tears|blink tears to be used twice a day
12003331|NCT00565669|Drug|Systane|systane to be used twice a day
12003332|NCT00565656|Drug|BEVACIZUMAB|Administration of Bevacizumab
12003333|NCT00565643|Device|modified sodium hyaluronic acid and carboxymethylcellulose|Adhesion barrier applied at the time of initial cesarean delivery
12003334|NCT00565643|Device|Placebo|Routine abdominal closure without placement of adhesion barrier
12003335|NCT00565630|Device|Vigamox delivered via the device in spray form|Vigamox delivered 4 times, 1 hour prior to cataract surgery
12003336|NCT00565617|Device|Synergy, Epidural cortical stimulation|Epidural cortical stimulation
12003337|NCT00565604|Device|Short Catheter Delivery|For treating incompetent perforator veins of the lower extremities
12003338|NCT00565591|Drug|Albuterol sulfate|Single dose dry powder by inhalation
12003339|NCT00565565|Drug|BAY60-4552|Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
12003340|NCT00565552|Drug|Silicone gel (Dermatix®)|The half one the scar to treat was randomised among patients. After regular cleaning of the skin around the scar one half was thinly creamed with the silicone gel from medial to lateral and let dry for 5 minutes. It was done twice daily.
12003341|NCT00565539|Drug|PEGylated recombinant interleukin 29 (PEG-rIL-29)|subcutaneous administration either weekly or every other week
12003342|NCT00565513|Procedure|blood test|cord blood and maternal milk test
12003343|NCT00565500|Drug|celecoxib|celecoxib capsules 200 mg bid for 1 week
12003344|NCT00565500|Drug|ibuprofen|ibuprofen tablets 600 mg tid for 1 week
12003345|NCT00565500|Drug|placebo|placebo capsules tid for 1 week
12003346|NCT00565487|Drug|Capecitabine, Tarceva|Capecitabine is a self-administered (oral) medication & will be dose escalated and administered in four dose levels: Level I - 600 mg/m2 bid; Level II - 700 mg/m2 bid; Level III - 825 mg/m2 bid; Level IV - 925 mg/m2 bid. Tarceva will be self-administered(orally) in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single agent Tarceva 100 mg/day. Treatment of Capecitabine & Tarceva is continued daily until the completeness of the radiation or toxicity.
12003347|NCT00565474|Drug|Fluvastatin|Graft vasculopathy
12003348|NCT00565461|Biological|heat-labile enterotoxin of E. coli (LT)|37.5ug patch applied on either the deltoid or the thigh
12003349|NCT00565448|Drug|docetaxel|"Pharmaceutical form:solution for infusion
~Route of administration:intravenous"
12003350|NCT00565448|Drug|cisplatin|"Pharmaceutical form:solution for infusion
~Route of administration:intravenous"
12003351|NCT00565448|Drug|5-fluorouracil|"Pharmaceutical form:solution for infusion
~Route of administration:intravenous"
12003352|NCT00565422|Drug|Escitalopram|10 mg/day
12003353|NCT00565409|Drug|Etanercept|Subcutaneous (SC), 50 mg, once weekly for 88 weeks
12003354|NCT00565409|Drug|Methotrexate|"Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
~If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week)."
12003355|NCT00565409|Drug|Etanercept|Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
12003356|NCT00565409|Drug|Methotrexate|"Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
~If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week)."
12003357|NCT00565409|Drug|Placebo|Subcutaneous (SC), once weekly from week 36 to week 88.
12003358|NCT00565409|Drug|Methotrexate|"Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
~If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week)."
12003359|NCT00565396|Drug|Fosinopril and Losartan|Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
12003360|NCT00565383|Procedure|Combined spinal-epidural analgesia|Combined spinal-epidural
12003361|NCT00565383|Procedure|Intravenous fentanyl (50mcg)|Intravenous fentanyl
12003362|NCT00565370|Drug|Capecitabine, Cisplatin, Sorafenib|Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks
12005053|NCT00553202|Drug|cyclophosphamide|Given IV
12003363|NCT00565357|Device|Silicone Earplugs|Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
12003364|NCT00565357|Other|Control|Standard care in the neonatal intensive care unit
12003365|NCT00565331|Drug|Rituximab|single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation
12003366|NCT00565331|Drug|Placebo|saline solution
12003367|NCT00565318|Drug|Benfotiamine|3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
12003368|NCT00565318|Drug|Placebo|3x 1 film coated tablet daily. Duration: 12 weeks.
12003369|NCT00565305|Behavioral|Healing Touch|Healing Touch (HT) is a non-invasive therapeutic approach to healing which describes its mode of action as using touch to modulate the patient's energy system. The goal of HT is to restore harmony and balance in the patient's energy system to assist the person to self-heal.88 Healing Touch, as used here, refers to the techniques taught in Mentgen's standardized curriculum of Healing Touch offered through Healing Touch International and endorsed by the American Holistic Nurse's Association
12003370|NCT00565305|Radiation|Standard Treatment|4-6 cycles of cytotoxic chemotherapy followed by 5040 cGy of external beam whole breast radiotherapy in 28 fractions usually followed by a boost of 1000-1600 cGy
12003371|NCT00565292|Drug|MK0859|
12003372|NCT00565279|Drug|ASF1057|Twice daily, topical
12003373|NCT00565279|Drug|ASF1057|Twice daily, Topical
12003374|NCT00565266|Drug|tiotropium bromide|tiotropium bromide inhalation powder 18 mcg once daily
12003375|NCT00565266|Drug|salmeterol xinafoate|salmeterol xinafoate inhalation powder 50 mcg twice daily
12003376|NCT00565266|Drug|beclomethasone dipropionate|beclomethasone dipropionate 80 mcg twice daily (1xICS) or 160 mcg twice daily (2xICS)
12003377|NCT00565253|Drug|Inhaled nitric oxide (NO)|20 ppm for 15 minutes
12003378|NCT00565240|Drug|Marvelon|oral contraceptive
12003379|NCT00565240|Drug|Nuvaring|contraceptive vaginal ring
12003380|NCT00565240|Drug|Letrozole|Aromatase Inhibitors
12003381|NCT00565227|Drug|vorinostat (suberoylanilide hydroxamic acid)|Vorinostat will be administered by mouth as a pill for the first 14 days on a continuous basis during of each 21-day cycle (2 weeks of treatment, 1 week break).
12003382|NCT00565227|Drug|docetaxel|Docetaxel will be administered as an intravenous infusion (through the vein) on day 4 of each 21-day cycle.
12003383|NCT00565214|Dietary Supplement|Group 1|The treatment plan involves the administration of a combination of 3 vitamins (vitamin C 1000 mg, vitamin E 400 IU, selenomethionine 400 μg) to study volunteers in a 2:1 randomization, Vitamins are to be taken orally, once a day, for a duration of 30 days.
12003384|NCT00565214|Dietary Supplement|Group 2|The treatment plan involves the administration of a combination of 3 placebos to be taken orally, once daily for a duration of 30 days.
12003385|NCT00565201|Drug|Botox and rehab|Patients will BOTOX® (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.
12003386|NCT00565201|Drug|Placebo and rehab|Patients will receive placebo saline (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.
12003387|NCT00565188|Drug|Adenosine 5'-triphosphate|Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min
12003388|NCT00565175|Drug|famotidine|Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.
12003389|NCT00565175|Drug|Placebo (Microcrystallized cellulose)|Placebo administered in identical capsules as the experimental drug.
12003390|NCT00565162|Drug|Insulin Glargine|Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.
12003391|NCT00565149|Behavioral|PROOF|dietary overfeeding with high, low or normal protein content
12003392|NCT00565136|Device|TOPAS|A mesh sling permanently implanted to increase pelvic floor support
12003393|NCT00565123|Drug|0.5% levofloxacin eye drops|0.5% levofloxacin eye drops three times daily to each eye for 5 days
12003394|NCT00565123|Drug|0.5% levofloxacin eye drops|0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)
12003395|NCT00565110|Behavioral|ADAPt-C intervention|Experimental Arm patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
12003396|NCT00565097|Drug|Placebo|
12003397|NCT00565097|Drug|Lanreotide|
12003398|NCT00565084|Drug|ibuprofen|Patients will receive 800 mg ibuprofen in one of the three treatment periods.
12003399|NCT00565084|Drug|Placebo|Patients will receive placebo to ibuprofen in two of the three treatment periods.
12003400|NCT00565071|Device|Field microscopy and Paracheck Pf®|Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
12003401|NCT00565058|Biological|GTI-2040|GTI-2040 will be administered one day after HiDAC in the pilot PD study and one day before HiDAC in the Phase II study for a cycle. Those who achieve a complete remission (CR) will be permitted to receive one cycle of consolidation of GTI-2040 and HiDAC
12003443|NCT00564720|Drug|Gemcitabine|Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
12003444|NCT00564720|Drug|Erlotinib|Erlotinib 100 mg by mouth (p.o.), daily until disease progression
12003402|NCT00565045|Device|Neuromuscular electrical stimulator|"Intervention Characteristics Common to Both Groups
~• 6-week intervention
~Home exercise, daily
~Exercise (at home) 2 sessions/day
~A session consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest
~A set entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions
~Lab therapy, 2x/week
~Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible)."
12003403|NCT00565019|Drug|Triamcinolone Acetonide|"Triamcinolone acetonide will be administered into the cord following surgery with a tuberculin syringe and a 25-gauge needle.
~Doses will range from 60-120 mg depending on extent of the disease.
~Patients will receive injections at 6 weeks and 3 months for persisting nodules or cords.
~PI will determine the dosages. Estimates will be made based on the following:
~Size of nodule/cord: 1-2 cm2, dosage 20-40 mg
~Size of nodule/cord: 2-6 cm2, dosage 40-80 mg
~Size of nodule/cord: 6-10 cm2, dosage 80-100 mg
~Size of nodule/cord: >10 cm2, dosage 100-120 mg"
12003404|NCT00565006|Drug|MK0859|
12003405|NCT00564993|Drug|Dobutamin|10&20 µg/kg/min
12003406|NCT00564980|Procedure|Wafer Procedure|A dorsal approach to the distal ulna is used dividing the extensor retinaculum between the 5th and 6th compartments. The ulnar head is exposed through a transverse capsulotomy. Cartilage and bone are resected to result in slight negative ulnar variance based on the preoperative pronated grip view. The ulnar styloid and TFCC attachments are preserved. The dorsal capsule and retinaculum are repaired in separate layers.
12003407|NCT00564980|Procedure|Ulnar shortening osteotomy|A longitudinal incision of approximately 8 cm is made at the distal third of the ulna along the ulnar border of the forearm. The interval between the flexor carpi ulnaris is used. The ulna is exposed at its distal third preserving the periosteum. Care is taken to protect the sensory branches of the lunar nerve. An oblique osteotomy is performed using a reciprocating saw, removing enough bone to result is slight negative ulnar variance. Fixation and compression at the osteotomy site is achieved using a 5 or 6 hole titanium LC-DCP plate.
12003408|NCT00564967|Behavioral|CBT via the Internet|15 weeks, patients learn about CBT primarily thru a self-help book published on teh Internet, Minimal therapy contact via e-mail(10 minutes/week),
12003409|NCT00564967|Behavioral|CBT group therapy|15 weeks, 1 session/week, (2,5 hours.)
12003410|NCT00564954|Drug|Dex-methylphenidate hydrochloride extended-release (Focalin XR)|20 mg capsule orally once a day for 7 days
12003411|NCT00564954|Drug|Placebo|orally once a day for 7 days
12003412|NCT00564941|Drug|deferasirox|
12003413|NCT00564928|Drug|IPI-504|IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle
12003414|NCT00564915|Dietary Supplement|Ketogenic diet|Ketogenic diet
12003415|NCT00564902|Drug|3R 3'R Zeaxanthin|8 mg per day during 12 months
12003416|NCT00564902|Dietary Supplement|Lutein|9 mg of Lutein during 12 months
12003417|NCT00564902|Dietary Supplement|Lutein and Zeaxanthin|8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months
12003418|NCT00564889|Drug|cyclophosphamide|300 mg/m^2 days 1, 8 & 15 of a 28 day cycle taken orally with food
12003419|NCT00564889|Drug|dexamethasone|40 mg weekly taken orally
12003420|NCT00564889|Drug|lenalidomide|15 mg daily days 1-21 of a 28 day cycle taken orally with food
12003421|NCT00564876|Drug|Dasatinib|Fresh frozen tumor tissue must be available prior to initiating dasatinib. Eligible patients will receive neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks followed by surgery. The surgical specimen will be evaluated for pathologic response. The second tumor sample will be obtained after 3 weeks of dasatinib therapy at the time of definitive surgical resection which will be evaluated for changes in genomic expression profiles. Patients with at least a 15% decrease or better objective response, without evidence of progression (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy.
12003422|NCT00564863|Biological|CS19 expressing ETEC strain|Wild type ETEC strain expressing the colonization faction CS19, and LT and ST enterotoxins.
12003423|NCT00564850|Drug|Triptorelin pamoate 11.25mg (Decapeptyl® SR)|One intra muscular injection at day 1 and month 3.
12003424|NCT00564837|Procedure|Home-based rehabilitation program|Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months
12003425|NCT00564837|Procedure|Physiotherapy-supervised rehabilitation program|Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months
12003426|NCT00564824|Drug|Caffeine|Caffeine 200 mg tablet
12003427|NCT00564824|Drug|Placebo|Placebo pills
12003428|NCT00564811|Dietary Supplement|Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)|Agaricus blazei powder, 10 grams/day, for 5 months
12003429|NCT00564785|Drug|Synera(TM)|Synera(TM) patch applied 20 minutes prior to epidural
12003430|NCT00564785|Other|Placebo patch|placebo patch applied 20 minutes prior to epidural
12003431|NCT00564772|Drug|Raltegravir, lopinavir, ritonavir|4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period.
12003432|NCT00564759|Drug|retroviral SF71-gp91phox transduced CD34+ cells|autologous ex-vivo retroviral transduced (SF71-gp91phox) CD34+ cells
12003433|NCT00564746|Drug|A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323|"[14C] SB-681323 oral solution, is available as a powder which will be made into a solution of 0.1 milligram/milliliter (0.5 microcurie) [14C] SB-681323 in dextrose and water for injection on the day prior to dosing.
~For a 10 milligram/50 microcurie oral dose of [14C]SB-681323, 100 milliliters of 0.1 milligram/milliliter (0.5 microcurie/milliliter [14C] SB-681323 oral solution will be dosed."
12003434|NCT00564733|Drug|carboplatin|Given IV
12003435|NCT00564733|Drug|docetaxel|Given IV
12003436|NCT00564733|Drug|gemcitabine hydrochloride|Given IV
12003437|NCT00564733|Drug|paclitaxel|Given IV
12003438|NCT00564733|Procedure|computed tomography|Undergo FDG PET/CT
12003439|NCT00564733|Procedure|positron emission tomography|Undergo FDG PET/CT
12003440|NCT00564733|Radiation|fludeoxyglucose F 18|Given IV
12003441|NCT00564733|Other|imaging biomarker analysis|Correlative studies
12003442|NCT00564720|Drug|Gemcitabine|Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
12005054|NCT00553202|Drug|cyclosporine|Given IV or orally
12003445|NCT00564720|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
12003446|NCT00564707|Behavioral|Biofeedback therapy|EMG guided biofeedback therapy using standard biofeedback computer software
12003447|NCT00564707|Procedure|Botulinum Toxin Type A Injection|Under EMG guidance Botox is injected directly into the painful levator ani muscle.
12003448|NCT00564694|Procedure|psychosocial assessment and care|
12003449|NCT00564694|Procedure|quality-of-life assessment|
12003450|NCT00564681|Biological|botulinum toxin type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
12003451|NCT00564681|Biological|botulinum toxin type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
12003452|NCT00564681|Drug|Normal Saline|Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
12003453|NCT00564668|Drug|biphasic insulin aspart|
12003454|NCT00564655|Procedure|bupivacaine with epinephrine (mid and upper abdomen)|Patients will receive localized infiltration of local anesthesia (0.25% bupivacaine with epinephrine 1:200,000) at the beginning of the procedure as is current standard practice. Localized anaesthetic of the mid and upper abdomen.
12003455|NCT00564655|Procedure|bupivacaine with epinephrine (transversus abdominis plane)|0.6 cc/kg (to a maximum of 20 ccs) of 0.25% bupivacaine with epinephrine 1:200,000 will be injected into the neuro-vascular plane between the internal oblique and transversus abdominis muscles. Regional anaesthetic block of the transversus abdominis plane.
12003456|NCT00564642|Drug|N Acetylcysteine|1200 mg, BD, 2weeks
12003457|NCT00564629|Drug|Intravenous acetaminophen plus oral placebo|Single dose of 1 gm IV acetaminophen
12003458|NCT00564629|Drug|Oral acetaminophen plus IV placebo|Single dose of 1 g PO APAP
12003459|NCT00564629|Biological|Reference standard endotoxin (RSE)|To subjects in both study arms: Administration of a 1 ng/kg body weight test dose of RSE to induce fever and test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.
12003460|NCT00564616|Device|video cell phone|"the voice group received voice CPR instruction via a voice-only cell phone, and the video group received interactive voice and video instruction via a video cell phone"
12003461|NCT00564603|Drug|Dexamethasone Sodium Phosphate Injection|Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
12003462|NCT00564603|Other|0.9% Saline|Saline, in same volume of 2mL
12003463|NCT00564590|Drug|Melatonin|4 mg of Melatonin once a day for 3 months
12003464|NCT00564590|Other|omeprazole|omeprazole 20 mg once a day
12003465|NCT00564590|Drug|Placebo|Placebo once a day
12003466|NCT00564577|Biological|CFA/I and CS17 challenge strain|Wild type ETEC strain expressing the colonization factor CS17, and heat labile (LT) enterotoxin
12003467|NCT00564564|Drug|Quetiapine|Quetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
12003468|NCT00564564|Drug|Clomipramine|Clomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
12003469|NCT00564551|Behavioral|High dairy and calcium intake|High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.
12003470|NCT00564551|Behavioral|Usual intake|Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet
12003471|NCT00564538|Drug|anti-thymocyte globulin (rabbit)|1.5mg/kg per dose with the first dose initiated in the operating room prior to reperfusion of the transplanted liver. It will then be administered again on post operative day #1, 3 and 5 for a total cumulative dose of 6mg/kg.
12003472|NCT00564538|Drug|tacrolimus|Tacrolimus will be administered orally on post op day #1 as per standard of care.
12003473|NCT00564525|Drug|Amitriptyline|Medication taken for 4 weeks
12003474|NCT00564525|Drug|Placebo|Medication taken for 4 weeks
12003475|NCT00564512|Biological|Campath|Fludarabine-Cyclophosphamide-Campath (FCCam)
12003476|NCT00564512|Biological|rituximab|Fludarabine-Cyclophosphamide-Rituximab (FCR)
12003477|NCT00564512|Drug|cyclophosphamide|Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)
12003478|NCT00564512|Drug|fludarabine|Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)
12003479|NCT00564486|Drug|IV Placebo|IV, every 6 hours for 24 hours (4 doses total)
12003480|NCT00564486|Drug|IV Placebo|IV, every 4 hours for 24 hours (6 doses total)
12003481|NCT00564486|Drug|IV Acetaminophen|IV, every 6 hours for 24 hours (4 doses total)
12003482|NCT00564486|Drug|IV Acetaminophen|IV, every 4 hours for 24 hours (6 doses total)
12003483|NCT00564473|Behavioral|questionnaire|"questionnaire of demographic and medical data, use of and attituded toward herbal medicine.
~Beck Depression Inventory-Second Edition (BDI-II)- Hebrew Translation"
12003484|NCT00564460|Drug|Finasteride|Finasteride 5 mg PO once daily for 8 weeks prior to TURP
12003485|NCT00564460|Drug|Placebo|Placebo once daily for 8 weeks
12003486|NCT00564447|Drug|Azithromycin|azithromycin topical solution 1% given as a single drop in a single eye
12003487|NCT00564447|Drug|Moxifloxacin|Moxifloxacin topical solution given as a single drop in a single eye
12003488|NCT00564421|Drug|epinastine nasal spray, low concentration, low dose volume|2 sprays in each nostril, dosed twice a day
12003489|NCT00564421|Other|placebo nasal spray|2 sprays in each nostril, dosed twice a day
12003490|NCT00564421|Drug|epinastine nasal spray, low concentration, high dose volume|2 sprays in each nostril, dosed twice a day
12003491|NCT00564421|Drug|epinastine nasal spray, high concentration, low dose volume|2 sprays in each nostril, dosed twice a day
12003492|NCT00564421|Drug|epinastine nasal spray, high concentration, high dose volume|2 sprays in each nostril, dosed twice a day
12003493|NCT00564408|Drug|Carbachol|3 microgram per kg bodyweight infused intravenously
12003494|NCT00564395|Drug|Insulin Detemir mixed with RAI injection|Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection
12005055|NCT00553202|Drug|methotrexate|Given IV
12003495|NCT00564395|Drug|Insulin Detemir and RAI injection|Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection
12003496|NCT00564382|Procedure|Cardiac magnetic Resonance study|Routine cardiac MR study including contrast application
12003497|NCT00564369|Other|CDC HIV testing recommendations|Current vs. prior CDC recommendations
12003498|NCT00564356|Procedure|cataract surgery with phacoemulsification|removal of cataract with phacoemulsification technique
12003499|NCT00564343|Other|water based training program to improve balance|The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week), 45 minute training session.
12003500|NCT00564330|Drug|Esomeprazole|20mg bid
12003501|NCT00564330|Drug|Placebo|Placebo bid
12003502|NCT00564317|Behavioral|KIDNET|Narrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events
12003503|NCT00564317|Behavioral|Meditation/Relaxation|a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
12003504|NCT00564291|Other|Examination with an OCT device|
12003505|NCT00564278|Drug|Standard antidepressant therapy (SADT)|Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
12003506|NCT00564278|Behavioral|Motivational antidepressant therapy (MADT)|The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.
12003507|NCT00564265|Other|Observation|Not applied
12003508|NCT00564252|Drug|topical finasteride|0.2%topical(cream)finasteride twice a day for six months
12003509|NCT00564239|Behavioral|Cognitive Behavioral Group Therapy|12 children group sessions, 8 parent group sessions
12003510|NCT00564239|Behavioral|Cognitive Behavioral Group Therapy|12 children group sessions
12003511|NCT00564226|Drug|SSR240600C|oral administration
12003512|NCT00564226|Drug|tolterodine|oral administration
12003513|NCT00564226|Drug|placebo|oral administration
12003514|NCT00564213|Drug|PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds|Mitomycin 0.02%
12003515|NCT00564200|Drug|Bortezomib|"PREACONDICIONAMIENTO:
~2 cycles of 21 days : Velcade days: 1, 4, 8 and 11
~1 cycle of 13 days : Velcade days 1, 4, 8 and 11
~ACONDICIONAMIENTO:
~- Day -2: Velcade
~POSTRANSPLANTATION:
~2 cycles of 21 days : Velcade days 1, 8 and 15
~5 cycles of 56 days : Velcade days 1, 8 and 15"
12003516|NCT00564200|Drug|dexamethasone|"PREACONDICIONAMIENTO:
~- 2 cycles of 21 days : Dexamethasone: days 1-4 and 8-11"
12003517|NCT00564200|Drug|Fludarabine|"ACONDICIONAMIENTO:
~- Days -9 al -5: Fludarabine"
12003518|NCT00564200|Drug|Melphalan|"ACONDICIONAMIENTO:
~- Days -4 and -3: Melphalan."
12003519|NCT00564187|Drug|Irbesartan|"Irbesartan: 150mg tablets
~Dosage: Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
~• 150mg/day for normalized patients and patients responding non normalized randomized in the group A"
12003520|NCT00564187|Drug|Irbesartan|"Irbesartan: 150mg tablets
~Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
~• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B"
12003521|NCT00564174|Drug|Low molecular weight heparin and low dose aspirin|Fragmin 5000 IU/day by subcutaneous injection started at time of randomization and continued until 35 weeks gestation or delivery and low dose aspirin 81 mg/day started pre-conception and continued until 35 weeks gestation or delivery
12003522|NCT00564174|Drug|Low dose aspirin|81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
12003523|NCT00564148|Drug|Avastin|2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
12003524|NCT00564135|Procedure|on Foley time|A-no Foley B-remove Foley at 7AM in the morning of postoperative day 1 C-remove Foley at 7AM in the morning of postoperative day 2
12003525|NCT00564122|Device|Artificially-Intelligent Stethoscope|After subjects' medical visits are complete, the heart sounds of all subjects will be recorded and assessed by an artificially-intelligent stethoscope. Attempts will be made to make satisfactory 20-second recordings from a total of eight positions on the chest with the patient in supine and upright positions.
12003526|NCT00564122|Other|Physical Examination|A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.
12003527|NCT00564109|Procedure|retrospective Observation|retrospective Observation
12003528|NCT00564096|Device|DEEP TMS H1 coil|"A new coil (H-coil invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) capable of stimulating more than twice this depth (Up to 5 cm) was recently developed and hence will be called deep TMS."
12003529|NCT00564096|Device|Deep H1 coil TMS|"A new coil (H-coil invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) capable of stimulating more than twice this depth (Up to 5 cm) was recently developed and hence will be called deep TMS."
12003530|NCT00564083|Procedure|sacral colpopexy|This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum)
12003531|NCT00564070|Behavioral|Enhanced treatment as usual plus adherence training|The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management.
12003532|NCT00564070|Behavioral|Enhanced treatment as usual plus CBT-AD|The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care.
12003533|NCT00564057|Drug|candesartan|tablet 8-16 mg once daily, one year
12003534|NCT00564057|Drug|lercanidipine|tablets 10-20 mg once daily, one year
12003649|NCT00563173|Drug|CHRONVAC-C®|DNA vaccine, solution for injection, i.m. administration in combination with electroporation
12003535|NCT00564044|Procedure|excision of the protruding mesh and its surrounding vaginal tissue|A piece of vaginal tissue 12mm*5mm*3mm in sized (for control group) and another piece of vaginal tissue combined with protruding mesh of the same size (for study group) will be obtained respectively for each of the two arms during intervention.
12003536|NCT00564031|Drug|Femanest|2mg/day
12003537|NCT00564031|Drug|gestapuran|5mg/day
12003538|NCT00564031|Drug|placebo|daily
12003539|NCT00564031|Drug|Femanest plus Gestapuran|combined daily
12003540|NCT00564018|Drug|Insulin detemir|Dosage adjusted to meet age-specific glycemic goals throughout course of study.
12003541|NCT00564018|Drug|Glargine|Dosage to be adjusted to meet age-specific glycemic goals throughout course of study.
12003542|NCT00564018|Drug|NPH|Dosage to be adjusted to meet age specific glycemic goals throughout course of study.
12003543|NCT00564005|Other|Constraint-induced therapy (CIT)|restraint of the unaffected arm and practice of the affected arm
12003544|NCT00564005|Other|Bilateral arm training (BAT)|bilateral symmetric, repetitive arm training
12003545|NCT00564005|Other|Combined therapy (CT)|combined different treatment approaches
12003546|NCT00564005|Behavioral|Control intervention|Conventional treatment program
12003547|NCT00563992|Drug|Lithium|Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.
12003548|NCT00563992|Drug|Valproic acid|Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.
12003549|NCT00563979|Dietary Supplement|VitaluxPlus®|1 tablet daily
12003550|NCT00563979|Dietary Supplement|Omega 3|1 tablet daily
12003551|NCT00563953|Drug|Liposomal pegylated doxorubicine|Four cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
12003552|NCT00563927|Procedure|Conventional RT|
12003553|NCT00563927|Drug|Cisplatin|
12003554|NCT00563927|Drug|5-fluorouracil|
12003555|NCT00563914|Drug|ferroquine (SSR97193)|associated with artesunate
12003556|NCT00563914|Drug|amodiaquine|associated with artesunate
12003557|NCT00563888|Behavioral|NET|Narrative Exposure Therapy for traumatized survivors of organized violence
12003558|NCT00563875|Drug|acetylsalicylic acid|75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin.
12003559|NCT00563862|Procedure|Conventional RT|
12003560|NCT00563862|Procedure|Accelerated RT|
12003561|NCT00563862|Drug|Cisplatin|
12003562|NCT00563862|Drug|5-fluorouracil|
12003563|NCT00563849|Drug|Leflunomide|concomitantly leflunomide (no loading dose, 10 mg/day) and methotrexate (starting at 7.5 mg/week and titrating up to 15 mg/week) for 20 weeks.
12003564|NCT00563836|Drug|Catumaxomab|10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
12003565|NCT00563823|Drug|vatalanib|
12003566|NCT00563810|Drug|MYO-029|
12003567|NCT00563797|Drug|Mecamylamine|mecamylamine 10mg/day for 12 weeks
12003568|NCT00563797|Drug|Placebo|Placebo pill
12003569|NCT00563784|Drug|Erlotinib|150 mg by mouth daily for 7 Weeks
12003570|NCT00563784|Drug|Carboplatin|2 AUC by vein weekly for 7 Weeks
12003571|NCT00563784|Drug|Paclitaxel|45 mg/m^2 by vein weekly for 7 Weeks
12003572|NCT00563784|Radiation|Radiation Therapy|63 GY/35 fractions for 7 weeks (+/- 5 days)
12003573|NCT00563771|Drug|Rasburicase|
12003574|NCT00563758|Drug|tegaserod|
12003575|NCT00563745|Device|telemedicine program|One year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing will be provided.
12003576|NCT00563732|Drug|Lecozotan|
12003577|NCT00563706|Drug|vabicaserin|This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
12003578|NCT00563706|Drug|risperidone|
12003579|NCT00563706|Other|placebo|
12003580|NCT00563693|Device|ASV|Adaptive servo ventilator
12003581|NCT00563693|Other|without Autoset CS2|without Autoset CS2
12003582|NCT00563680|Drug|AMG 479|AMG 479 is a fully human monoclonal antibody (IgG1) against the insulin-like growth factor receptor-1 (IGF-1R). IGF-1R signaling has been shown to play a critical role in the survival of cancer cells. AMG 479 inhibits the binding of both IGF-1 and IGF-2 to IGF-1R, thus inhibiting ligand-dependent receptor activation. Inhibition of IGF-1R signaling with AMG 479 provides a potential mechanism for inhibiting tumor growth and survival.
12003583|NCT00563667|Procedure|pterygium excision|
12003584|NCT00563654|Drug|Alfuzosin GITS (Xatral XL)|
12003585|NCT00563641|Other|Very early surfactant and bubble NCPAP|For patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O
12003586|NCT00563641|Other|bubble NCPAP|"Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach yes or no treatment failure criteria."
12003587|NCT00563628|Device|Panretinal photocoagulation with PASCAL system|Use the PASCAL laser system to deliver a retina photocoagulation
12003588|NCT00563615|Drug|Tegaserod|
12003589|NCT00563602|Other|Hemodynamic guided therapy|"To switch two or more different treatments for the prevention of variceal rebleeding according to the hemodynamic response. All patients in the experimental group will begin by:
~1) LEV + Nadolol. HVPG measurement: if response, no changes, if not, switch to 2) LEV + Nadolol + MNI. HVPG measurement: if response, no changes, if not, switch to: 3) LEV + Nadolol + Prazosin. (drugs carefully titrated until achieve maximum tolerated dose)"
12003590|NCT00563589|Drug|mycophenolate mofetil, methotrexate, cyclosporin|
12003591|NCT00563589|Drug|Methotrexate and cyclosporin|
12003650|NCT00563160|Drug|gemcitabine, carboplatin|
12003651|NCT00563160|Procedure|surgery|
12003592|NCT00563576|Drug|Femring®|"Estrogen vaginal ring (100 mcg) placed for the first 90 days of Depo-Provera use.
~Femring® (estradiol acetate vaginal ring) is a flexible off-white ring designed for vaginal insertion with measurements that include an outer diameter of 56 mm, cross-sectional diameter of 7.6 mm, and core diameter of 2 mm. Femring® 0.1 mg/day has a central core containing 24.8 mg of estradiol acetate which releases at a rate equivalent to 0.1 mg of estradiol per day for 3 months."
12003593|NCT00563576|Drug|DepoProvera ®|Medroxyprogesterone intramuscular injection comes as a suspension (liquid) to be injected into the buttocks or upper arm. It is usually given once every 3 months (13 weeks), and the recommended dose is 150 mg.
12003594|NCT00563563|Drug|NB32|All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.
12003595|NCT00563563|Behavioral|Ancillary therapy|During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
12003596|NCT00563537|Radiation|18F-X PET SCAN|18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)
12003597|NCT00563524|Drug|ILV-094|SC and IV administration on days 1, 14, 28, and 42
12003598|NCT00563511|Procedure|adherence intervention|
12003599|NCT00563511|Procedure|intervention without adherence advice|
12003600|NCT00563511|Procedure|control|
12003601|NCT00563498|Drug|Glutamine|
12003602|NCT00563485|Drug|Doxazosin GITS (Cardura XL)|
12003603|NCT00563485|Drug|Terazosin (Hytrin)|
12003604|NCT00563472|Drug|estetrol|10 mg orally per day for 28 days
12003605|NCT00563472|Drug|estetrol|20 mg orally per day for 28 days
12003606|NCT00563472|Drug|estetrol and desogestrel|20 mg estetrol and 150 microg desogestrel orally per day for 28 days
12003607|NCT00563472|Drug|estetrol and progesterone|20 mg estetrol and 200 mg progesterone orally per day for 28 days
12003608|NCT00563459|Drug|carisbamate|400-1200 mg/day for 12 months
12003609|NCT00563459|Drug|topiramate|200-400mg/day for 12 months
12003610|NCT00563459|Drug|levetiracetam|1000-3000mg/day for 12 months
12003611|NCT00563446|Drug|Darbepoetin alfa|
12003612|NCT00563433|Drug|ofloxacin|400 mg twice a day for 14 days
12003613|NCT00563433|Drug|MSI-78|1%/2% topical cream twice a day for 14 days
12003614|NCT00563420|Procedure|Bronchoscopy|
12003615|NCT00563394|Drug|ofloxacin|400 mg twice a day for 14 days
12003616|NCT00563394|Drug|MSI-78|1%/2% topical cream twice a day for 14 days
12003617|NCT00563381|Drug|Tiotropium bromide|18 mcg/daily
12003618|NCT00563381|Drug|Salmeterol|100 mcg/daily
12003619|NCT00563381|Drug|Placebo Salmeterol|Placebo identical to Salmeterol device
12003620|NCT00563381|Drug|Placebo Tiotropium|Placebo identical to Tiotropium device
12003621|NCT00563368|Drug|VI-0521|phentermine 15 mg and topiramate 92 mg, po once daily
12003622|NCT00563368|Drug|VI-0521|phentermine 7.5 mg and topiramate 46 mg, po once daily
12003623|NCT00563368|Drug|topiramate|topiramate 46 mg, po once daily
12003624|NCT00563368|Drug|topiramate|topiramate 92 mg, po once daily
12003625|NCT00563368|Drug|phentermine|phentermine 7.5 mg, po once daily
12003626|NCT00563368|Drug|phentermine|phentermine 15 mg, po once daily
12003627|NCT00563368|Drug|VI-0521|placebo, po once daily
12003628|NCT00563355|Drug|erythropoietin|
12003629|NCT00563342|Drug|Ethanol|Examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis
12003630|NCT00563329|Procedure|Reduction Intervention + Adherence Intervention|
12003631|NCT00563329|Behavioral|Reduction Intervention|
12003632|NCT00563329|Procedure|control|
12003633|NCT00563316|Drug|Panitumumab|The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.
12003634|NCT00563316|Drug|Irinotecan|The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.
12003635|NCT00563303|Drug|hydrocortisone|200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6
12003636|NCT00563303|Drug|NaCl|48mL from Day 1 to Day 6
12003637|NCT00563290|Drug|dasatinib|Given PO
12003638|NCT00563290|Other|laboratory biomarker analysis|Correlative studies
12003639|NCT00563277|Procedure|combined pterygium and cataract operation|
12003640|NCT00563277|Procedure|pterygium excision followed by cataract operation|
12003641|NCT00563264|Behavioral|KAN-DO|"The 10 month KAN-DO intervention includes eight mailed interactive activity modules involving both the preschooler and mother that include relevant printed materials emphasizing parenting skills, healthy eating habits and increased physical activity. Mailed kits will each be followed by a supportive telephone counseling session based on motivational interviewing techniques. Mailed modules and telephone calls will be supplemented with two in-person motivational and informational sessions (at the beginning and in the middle of the intervention period).
~The Active Comparator group will receive monthly newsletters over the 10 month period related to boosting reading skills in their preschool children."
12003642|NCT00563251|Drug|Azithromycin|
12003643|NCT00563251|Drug|Placebo tablet|
12003644|NCT00563238|Drug|Metoprolol|Metoprolol administered intravenously in 2.5mg boluses until the resting heart rate falls by 10% from baseline to a maximum dose of 10mg, or until there is any apparent adverse reaction.
12003645|NCT00563225|Drug|Insulin Glargine|Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
12003646|NCT00563212|Drug|aerosol interferon-gamma|aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year
12003647|NCT00563199|Behavioral|nurse-delivered stage-matched smoking cessation counseling|
12003648|NCT00563186|Other|Admission to a novel hospital ward|Hospital admission to a ward with novel infection control design features (e.g., abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms, absence of curtains)
12003882|NCT00561548|Procedure|rectosigmoïdal biopsies|rectosigmoïdal biopsies
12003652|NCT00563147|Drug|tivozanib (AV-951) plus temsirolimus|ascending doses of tivozanib (AV-951) capsules administered orally for 21 days with discontinuation for 7 days; ascending doses of temsirolimus administered intravenously every 7 days
12003653|NCT00563134|Drug|GR270774|
12003654|NCT00563121|Procedure|Vitrectomy|Open-Sky vitrectomy, with resection of the tunica vasculosa lentis, and retinal reattachment
12003655|NCT00563108|Drug|Basiliximab|
12003656|NCT00563108|Drug|Placebo|
12003657|NCT00563095|Procedure|Transcatheter Arterial Chemoembolization (TACE)|
12003658|NCT00563095|Procedure|Transcatheter Arterial Pegylated Interferon Embolization (TAIE)|
12003659|NCT00563069|Drug|Midazolam|
12003660|NCT00563056|Drug|Flutiform|
12003661|NCT00563056|Drug|Flixotide plus Foradil|
12003662|NCT00563043|Procedure|PASCAL laser treatment|Patterns Scan Laser treatment in patients with PDR.
12003663|NCT00563017|Drug|Long-acting Risperidone microspheres injection|
12003664|NCT00563004|Dietary Supplement|DBCARE|Patients receive dbcare 2 tablets TID for 3 months
12003665|NCT00563004|Dietary Supplement|DBCARE|PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS
12003666|NCT00562991|Device|measurement of exhaled NO is used to guide treatment|exhaled NO
12003667|NCT00562978|Biological|filgrastim|
12003668|NCT00562978|Drug|cyclophosphamide|
12003669|NCT00562978|Drug|etoposide|
12003670|NCT00562978|Procedure|autologous hematopoietic stem cell transplantation|
12003671|NCT00562978|Procedure|peripheral blood stem cell transplantation|
12003672|NCT00562978|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12003673|NCT00562965|Drug|inotuzumab ozogamicin|IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
12003674|NCT00562965|Drug|rituximab|IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
12003675|NCT00562965|Drug|rituximab|intravenous rituximab at a dose of 375 mg/m2 on day 1
12003676|NCT00562965|Drug|cyclophosphamide|intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
12003677|NCT00562965|Drug|vincristine|intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
12003678|NCT00562965|Drug|prednisone/prednisolone|oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
12003679|NCT00562965|Drug|mitoxantrone|mitoxantrone 10 mg/m2 intravenous on day 2
12003680|NCT00562965|Drug|fludarabine|fludarabine 25 mg/m2 intravenous on days 2 through 4
12003681|NCT00562965|Drug|dexamethasone|oral dexamethasone 20 mg/day on days 1-5
12003682|NCT00562952|Drug|Telmisartan, Bisoprolol|Dosage will be given dependent on the NT-pro-BNP levels. Up-titration will be performed until values are decreased to 50% or below normal cut-point
12003683|NCT00562952|Drug|placebo|no intervention
12003684|NCT00562939|Biological|Pneumococcal vaccines + CPG 7909|Day 0: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 90: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 270: 0.5 ml Pneumo Novum + 1 mg CpG 7909, IM
12003685|NCT00562939|Biological|Pneumococcal vaccines|Day 0: 1 ml Prevenar (double dose) + placebo, IM Day 90: 1 ml Prevenar (double dose) + placebo, IM Day 270: 0.5 ml Pneumo Novum + placebo, IM
12003686|NCT00562926|Procedure|Extraction of 10ml blood sample for extraction of genomic DNA using DNA purification kits|
12003687|NCT00562913|Drug|Nexavar (Sorafenib, BAY43-9006)|Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin
12003688|NCT00562900|Procedure|robotic assisted cholecystectomy|robotic assisted cholecystectomy
12003689|NCT00562900|Procedure|Laparoscopic cholecystectomy|Laparoscopic cholecystectomy
12003690|NCT00562887|Biological|Placebo|every 4 weeks, IV
12003691|NCT00562887|Biological|ABT-874|400 mg IV every 4 weeks
12003692|NCT00562887|Biological|ABT-874|700 mg IV every 4 weeks
12003693|NCT00562874|Dietary Supplement|Meat Biscuit|75 women and one of their children will receive a biscuit containing dried meat as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day.
12003694|NCT00562874|Dietary Supplement|Soy Biscuit|75 women and one of their children will receive a biscuit containing soy four as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day.
12003695|NCT00562874|Dietary Supplement|Wheat Biscuit|75 women and one of their children will receive a biscuit containing only wheat lour as a source of protein as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 8 grams of protein per day and children will receive 350 calories and 5 grams of protein per day.
12003696|NCT00562861|Drug|citalopram + mood stabilizer|Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.
12003697|NCT00562861|Drug|placebo + mood stabilizer|This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.
12003698|NCT00562848|Drug|GSK962040|GSK962040 will be supplied in the following tablet strengths: 1 milligram, 5m milligrams, 25 milligrams, 125 milligrams.
12003699|NCT00562848|Drug|Placebo|Subjects will receive placebo.
12003700|NCT00562835|Drug|Methylprednisolone|"Drug: Methylprednisolone Day 0 Loading dose 1 mg/kg IV bolus (30 min) followed by continuous infusion; Days 0 to 14*† ‡ 1 mg/kg/day mixed in 240cc Normal saline (NS) and infused at 10 cc/hr; Days 15 to 21*‡ 0.5 mg/kg/day mixed in 240cc NS and infused at 10 cc/hr; Days 22 to 25*‡ 0.25 mg/kg/day; Days 26 to 28*‡ 0.125 mg/kg/day
~*Five days after the patient is able to ingest medications, methylprednisolone is given per os in one single daily equivalent dose.
~†If between days 1 to 14 the patient is extubated, he is advanced to day 15 of drug therapy and tapered according to schedule.
~‡ When leaving ICU, if the patient is still not tolerating p.o. intake for at least five days, he should receive the specified dosage as IV push every 6 hours until tolerating oral ingestion"
12003883|NCT00561535|Dietary Supplement|Lactobacillus FARCIMINIS|10.10 UFC of lactobacillus FARCIMINIS
12003701|NCT00562835|Other|Normal saline intravenously and vitamin B1 per os|Patients in this group will receive sterile normal saline in an amount that would equal the total diluted dose of study drug (ie. if initial loading dose equals a total of 25 cc [prednisolone + diluting fluid], then the patient will receive 25 cc of sterile normal saline). Tapering doses will be equivalent to that of the study arm. Five days after the patient is able to ingest medications, placebo is administered per os in one single daily equivalent dose. The placebo will be a Vitamin B1 (thiamine) 50-mg tablet. We will now designate each placebo tab as a 16-mg equivalent to each tablet of active drug. These tablets are scored and half tabs can be given if needed. Therefore if a patient is receiving 40 mg of study drug: 40/16 = 2.5 tabs x 50 mg = 125 mg actual dose of thiamine.
12003702|NCT00562822|Procedure|Arthroscopic surgery|Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee
12003703|NCT00562822|Other|Physical and medical therapy|Treatment with physical and medical therapy alone
12003704|NCT00562809|Drug|IRBESARTAN|150/12.5 mg tablets one or two tablets orally per day
12003705|NCT00562783|Drug|Vitaliver|
12003706|NCT00562783|Drug|Placebo|
12003707|NCT00562770|Drug|Valganciclovir|900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.
12003708|NCT00562770|Drug|Valacyclovir|500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
12003709|NCT00562744|Other|Simulation|Use of high-fidelity patient simulator for training and assessment of PALS scenario performance
12003710|NCT00562731|Drug|ARD-0403|Daily transdermal ARD-0403
12003711|NCT00562718|Drug|capecitabine|
12003712|NCT00562718|Procedure|adjuvant therapy|
12003713|NCT00562718|Radiation|radiation therapy|
12003714|NCT00562705|Behavioral|growth hormone- Genotropin or NorditropinSimplex and nutritional intervention|"A combined treatment of growth hormone (Genotropin or NorditropinSimplex or Biotropin) and nutritional intervention"
12003715|NCT00562705|Behavioral|"growth hormone-Genotropin or NorditropinSimplex or Biotropin"|"Growth hormone treatment (Genotropin, or NorditropinSimplex or Biotropin)."
12003716|NCT00562692|Drug|Nesiritide|Nesiritide 4 hour infusion
12003717|NCT00562692|Drug|Placebo|Placebo infusion
12003718|NCT00562679|Other|There is no intervention|
12003719|NCT00562666|Other|T gamma delta lymphocytes|Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
12003720|NCT00562640|Biological|filgrastim|Stem cell mobilization and harvest: Patients receive filgrastim (G-CSF) subcutaneously daily for five days. PBMC are collected by leukapheresis on the fifth day and then cryopreserved for subsequent reinfusion into the patient, in the event of prolonged cytopenia.
12003721|NCT00562640|Biological|therapeutic autologous lymphocytes|Autologous T-cell infusion with or without conditioning chemotherapy ( fludarabine treatment closed as of 12/01/2009): Approximately 4-6 weeks after T-cell sensitization, patients receive an infusion of autologous WT1-specific T cells over 5-10 minutes on day 0. Patients enrolled in dose levels II and III also undergo pre-infusion lymphodepletive conditioning comprising cyclophosphamide IV on day -2 and fludarabine phosphate IV over approximately 30 minutes on days -6 to -2. After a 48-hour rest period, patients receive autologous WT1-specific T cells. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after completion of therapy, may receive additional courses of autologous WT1-specific T cells every 14 days.
12003722|NCT00562640|Drug|cyclophosphamide|Patients enrolled in dose levels II and III also undergo pre-infusion lymphodepletive conditioning comprising cyclophosphamide IV on day -2
12003723|NCT00562640|Other|laboratory biomarker analysis|Obtained prior to adoptive therapy to quantitate baseline levels of WT1 reactive T cells, by quantitation of WT1 specific CTLp by LDA, T cells secreting IFNγ in response to peptide and, in HLA A0201+ patients, T cell binding WT1 peptide HLA A2 tetramers.
12003724|NCT00562627|Drug|ropivacaine|intraoperative and 1. postoperative day
12003725|NCT00562627|Drug|adrenaline|intraoperative LIA (IV and IA) and continuous EDA
12003726|NCT00562627|Drug|ketorolac|intraoperative and 1. postoperative day
12003727|NCT00562627|Drug|morphine|intraoperative
12003728|NCT00562627|Drug|fentanyl|continuous postoperatively
12003729|NCT00562627|Drug|bupivacaine|continuous postoperatively
12003730|NCT00562614|Drug|SLx-2101|
12003731|NCT00562588|Drug|Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg)|
12003732|NCT00562588|Drug|ASA 100 mg qd|
12003733|NCT00562575|Drug|SLx-4090|
12003734|NCT00562575|Drug|Placebo|
12003735|NCT00562562|Other|osteopathic manipulative treatment|Treatment will focus on the thoracolumbar junction, L5, the sacrum, and the pubes. Treatment will primarily utilize two techniques, muscle energy and ligamentous-articular release, but will be tailored to the findings of the individual patient.
12003736|NCT00562549|Drug|SLx-2101|
12003737|NCT00562536|Procedure|Umbilical cord clamping|Delay of umbilical cord clamping 30 to 45 seconds
12003738|NCT00562523|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks
12003739|NCT00562510|Drug|Raltegravir|Raltegravir 400 mg BID added to stable HAART
12003740|NCT00562510|Drug|Placebo|Placebo BID added to stable HAART
12003741|NCT00562497|Drug|Prochymal|Subjects will be treated with a total of 6 infusions of investigational agent during the first 4 weeks of the study. Four infusions will be administered during the first two weeks (twice weekly), then two infusions administered during the next two weeks (once weekly). Subjects assigned to the active treatment group will receive Prochymal™ at 2 x 106 human mesenchymal stem cells (hMSC)/kg per infusion.
12003742|NCT00562497|Other|Placebo|Subjects will be treated with a total of 6 infusions of investigational agent during the first 4 weeks of the study. Four infusions will be administered during the first two weeks (twice weekly), then two infusions administered during the next two weeks (once weekly). Subjects assigned to the non active treatment group will receive placebo (excipient, less cells). It is recommended that all subjects receive all six infusions. The discontinuation of investigational agent is allowed for GVHD worsening with subsequent need for salvage therapy. All infusions must be given at least 3 days apart.
12003743|NCT00562484|Biological|CSL Limited Influenza Vaccine|A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
12003744|NCT00562484|Biological|Placebo|Placebo
12003745|NCT00562471|Other|Adhibit Adhesion Prevention Gel|A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.
12003746|NCT00562471|Other|Standard of Care Comparator|standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure
12003747|NCT00562458|Drug|anastrozole|
12003748|NCT00562432|Device|Plexisyl-AF|Plexisyl-AF implants
12003749|NCT00562432|Other|No Treatment|CABG without the experimental treatment
12003750|NCT00562419|Drug|CT-322|IV solution, weekly
12003751|NCT00562419|Drug|irinotecan hydrochloride|IV solution, biweekly
12003752|NCT00562406|Drug|Ranibizumab|intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
12003753|NCT00562406|Procedure|Laser photocoagulation|laser photocoagulation to the retina at the area of edema
12003754|NCT00562393|Other|Nutritional|Overfeeding high fat diet for 28 days
12003755|NCT00562380|Biological|ganitumab|
12003756|NCT00562380|Other|laboratory biomarker analysis|
12003757|NCT00562380|Other|pharmacological study|
12003758|NCT00562380|Procedure|biopsy|
12003759|NCT00562367|Drug|Cytomel (liothyronine)|Cytomel (liothyronine) 25-50 mcg/day for 4 weeks
12003760|NCT00562354|Biological|13vPnC|13vPnC for both stratum
12003761|NCT00562341|Other|Bariatric Surgery|one time lapb-band gastric bypass surgery
12003762|NCT00562328|Biological|Alemtuzumab|"Week 1 (dose escalation):
~Day 3: 3mg subcutaneously; Day 4: 10mg subcutaneously; Day 5 30mg subcutaneously
~Weeks 2-5:
~30mg subcutaneously three times a week."
12003763|NCT00562328|Biological|Rituximab|"Weeks 2-5:
~375 mg/m^2 by IV once weekly"
12003764|NCT00562328|Biological|Sargramostim|"Week 1-6:
~250 mcg subcutaneously three time as week"
12003765|NCT00562315|Drug|FACBC|Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan
12003766|NCT00562315|Other|ProstaScinct|ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.
12003767|NCT00562302|Device|Bio-Seal Plug|Deployment of the Bio-Seal plug in needle track
12003768|NCT00562289|Drug|aspirin|during the follow up
12003769|NCT00562289|Drug|Antivitamins K or rivaroxaban or dabigatran or apixaban|during the follow up
12003770|NCT00562289|Device|Devices for PFO closure|endovascular treatment no longer than 21 days after the random.
12003771|NCT00562276|Procedure|Immediate IUD insertion|Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
12003772|NCT00562263|Behavioral|Lifestyle modification|Dietary modification and regular physical activity
12003773|NCT00562250|Drug|Dapagliflozin|Tablets, Oral, 20 mg, once daily, single dose
12003774|NCT00562250|Drug|Glimepiride|Tablets, Oral, 4 mg, once daily, single dose
12003775|NCT00562250|Drug|Dapagliflozin + Glimepiride|Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose
12003776|NCT00562237|Biological|S205 placebo|2 i.m. injections per subject (0.5 mL each)
12003777|NCT00562237|Biological|S205 10ugHA|2 i.m. injections per subject (0.5 mL each)
12003778|NCT00562237|Biological|S205 30ugHA|2 i.m. injections per subject (0.5 mL each)
12003779|NCT00562237|Biological|S205 10ugHA+500ugAlOH|2 i.m. injections per subject (0.5 mL each)
12003780|NCT00562237|Biological|S205 30ugHA+500ugAlOH|2 i.m. injections per subject (0.5 mL each)
12003781|NCT00562237|Biological|S205 10ugHA+1250ugAlOH|2 i.m. injections per subject (0.5 mL each)
12003782|NCT00562237|Biological|S205 30ugHA+1250ugAlOH|2 i.m. injections per subject (0.5 mL each)
12003783|NCT00562224|Drug|PCI-24781|"Up to 7 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day approximately 4 hours apart (TID), up to 90 mg/m2, administered 5 days/week during the first 21 days of each 28 day cycle until MTD is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 twice a day approximately 4 hours apart (BID). If a DLT occurs on the BID schedule, the subsequent cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle). If a DLT occurs on this dosing schedule, then the next cohort will receive PCI-24781 BID for 5 days/week every other week (2 times in a 28 day cycle) until the maximum tolerated dose is reached."
12003784|NCT00562211|Drug|LidoDyn|Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
12003785|NCT00562211|Drug|EMLA creme|Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
12003786|NCT00562198|Drug|entacapone and carbidopa|Entacapone 200mg carbidopa 50mg
12003787|NCT00562198|Drug|Sinemet 200mg/50mg|Sinemet 200mg/50mg once
12003788|NCT00562185|Drug|carboplatin|
12003789|NCT00562185|Drug|doxorubicin hydrochloride|
12003790|NCT00562172|Drug|Insulin glargine|Once daily in the morning
12003791|NCT00562172|Drug|Glimepiride|Once daily in the morning
12003792|NCT00562172|Drug|Metformin|At least 1000 mg/day
12003793|NCT00562159|Drug|Placebo|Placebo sublingual tablet
12003794|NCT00562159|Biological|SCH 697243|SCH 697243 (2800 Bioequivalent Allergen Units [BAU] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily.
12003795|NCT00562159|Drug|Loratadine 10 mg Rescue Treatment|Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.
12003796|NCT00562159|Drug|Olopatadine 0.1% Rescue Treatment|Olopatadine hydrochloride 0.1% ophthalmic solution was administered intraocularly at a dose of 1 drop in each affected eye twice daily as rescue medication for rhinoconjunctivitis, as needed.
12003884|NCT00561535|Dietary Supplement|placebo (starch)|Once daily
12003797|NCT00562159|Drug|Mometasone 50 mcg Rescue Treatment|Mometasone furoate monohydrate nasal spray 50 mcg was admininstered intranasally at a dose of 2 sprays in each nostril once daily as rescue medication for rhinoconjunctivitis, as needed.
12003798|NCT00562159|Drug|Prednisone 5 mg Rescue Treatment|"Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day
~(maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for rhinoconjunctivitis among participants with a total symptom score of ≥ 4 despite treatment with loratadine and mometasone furoate nasal spray."
12003799|NCT00562159|Drug|Albuterol sulfate 108 mcg|Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administed via inhalation at a dose of 2 inhalations every 4 to 6 hours, as needed, as rescue medication for asthma.
12003800|NCT00562159|Drug|Fluticasone propionate 44 mcg|Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of two inhalations twice daily, to a maximum dose of 10 inhalations twice daily, as rescue medication for asthma among participants utilizing four or more albuterol sulfate inhalations/day for 2 days for nocturnal asthma or shortness of breath.
12003801|NCT00562159|Drug|Prednisone 5 mg|Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day (maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for asthma at the discretion of the investigator for the treatment of asthma exacerbation.
12003802|NCT00562146|Procedure|placement of spiral nasojejunal tube|spiral nasojejunal tube will be placed after enrollment of the patients
12003803|NCT00562133|Drug|Insulin Glulisine|100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal
12003804|NCT00562133|Drug|Insulin|100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal
12003805|NCT00562120|Drug|Placebo|A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.
12003806|NCT00562120|Drug|Allegra|A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.
12003807|NCT00562120|Drug|Allegra-D|A single oral dose of Allegra-D is dosed to subjects as an active comparator.
12003808|NCT00562120|Drug|PF-03654746|A single oral dose of PF-03654746 is the investigational drug being studied.
12003809|NCT00562107|Device|Symphony DR 2550 and REPLY DR cardiac pacemakers|AAISafeR/SafeR ON
12003810|NCT00562107|Device|Symphony DR 2550 and REPLY DR cardiac pacemakers|DDD(R) (SafeR OFF)
12003811|NCT00562094|Drug|Pantoprazole|This was an observational study. Therefore, the physician decided about dosage according to individual needs.
12003812|NCT00562081|Behavioral|Education|24/7 access to a Certified Asthma Educator
12003813|NCT00562081|Behavioral|Education|Patient does not have 24/7 access to a Certified Asthma Educator.
12003814|NCT00562068|Biological|alemtuzumab|
12003815|NCT00562068|Drug|cyclophosphamide|
12003816|NCT00562068|Drug|doxorubicin hydrochloride|
12003817|NCT00562068|Drug|prednisolone|
12003818|NCT00562068|Drug|vincristine sulfate|
12003819|NCT00562068|Genetic|polymerase chain reaction|
12003820|NCT00562068|Other|flow cytometry|
12003821|NCT00562068|Other|laboratory biomarker analysis|
12003822|NCT00562068|Other|pharmacological study|
12003823|NCT00562055|Drug|Atomoxetine|
12003824|NCT00562055|Drug|PNU-165442G; [S,S]-reboxetine|
12003825|NCT00562029|Procedure|Duodenal-jejunal Bypass|Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
12003826|NCT00562016|Device|IMPLELLA LP 2.5|Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5 L/min.
12003827|NCT00562016|Device|IABP Intra-aortic balloon pump|IABP uses counterpulsation to provide 0.2L/min coronary flow
12003828|NCT00562003|Procedure|Tenckhoff Catheter placement|'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department.
12003829|NCT00562003|Drug|Ad5-delta24RGD|"Within two weeks before the start of the study, a physical exam, blood tests, removal of fluid from abdominal cavity through the catheter and a CT scan of abdomen and pelvis will be performed.
~The procedure will involve receiving the Ad5-delta24RGD virus once a day for 3 days. The virus will be put into the abdominal cavity through a 'Tenckhoff catheter'."
12003830|NCT00561990|Drug|Nimotuzumab|
12003831|NCT00561977|Behavioral|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
12003832|NCT00561977|Behavioral|low saturated fat diet|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal/day.
12003833|NCT00561977|Behavioral|Combination diet|combination low saturated fat high fiber diet, with calorie restriction as specified.
12003834|NCT00561964|Drug|Irbesartan|Irbesartan capsules strength 150 mg. Irbesartan group will be initiated at one irbesartan and one placebo for 2 weeks and titrated at two capsules if well tolerated after 2 weeks , this dose will be maintained throughout the study without further dose-adjustment (2 capsules daily in the morning will be taken from randomization to study end)
12003835|NCT00561964|Drug|placebo|Placebo group: 2 placebo capsules daily as a single morning intake
12003836|NCT00561951|Drug|fesoterodine fumarate|8mg tablets OD for 12 weeks
12003837|NCT00561951|Drug|Placebo|Corresponding placebo tablets OD for 12 weeks
12003838|NCT00561951|Drug|fesoterodine fumarate|4mg tablets OD for 12 weeks
12003839|NCT00561938|Procedure|Colonoscopy|microscope with a confocal window in its distal part. During ongoing endoscopy, 5 mL of 10% fluorescein (Novartis) will be injected intravenously to perform CLE imaging. In brief, CLE images are obtained few seconds after fluorescein injection by gentle positioning of the confocal window in contact with the digestive mucosa. To stabilize images, some suction can be applied using the operating channel of the endoscope. CLE images ('optical biopsies') will be stored and 1-2 standard biopsies will be performed in the examined area in order to further compare optical and standard biopsies. The overall duration of the procedure will be limited to 1 hour. During and after the procedure, patients will be monitored and surveyed continuously by anaesthesiologist. General tolerance and potential late adverse events will be assessed by the careful inquiry performed 1 month after the procedure by consultant gastroenterologist.
12003840|NCT00561938|Procedure|Endoscopy|After obtaining a written informed consent from all the patients, standard upper GI endoscopy or colonoscopy will be performed under general anaesthesia using a videoendoscope EC-3870 (Pentax), which includes a miniaturized microscope with a confocal window in its distal part. During ongoing endoscopy, 5 mL of 10% fluorescein (Novartis) will be injected intravenously to perform CLE imaging. In brief, CLE images are obtained few seconds after fluorescein injection by gentle positioning of the confocal window in contact with the digestive mucosa. To stabilize images, some suction can be applied using the operating channel of the endoscope. CLE images ('optical biopsies') will be stored and 1-2 standard biopsies will be performed in the examined area in order to further compare optical and standard biopsies. The overall duration of the procedure will be limited to 1 hour. During and after the procedure, patients will be monitored and surveyed continuously by anaesthesiologist.
12003841|NCT00561925|Drug|nevirapine IR|200 mg BID
12003842|NCT00561925|Drug|nevirapine XR|400 mg QD
12003843|NCT00561912|Drug|Decitabine|15 mg/m^2 IV Daily over one hour for 5 days
12003844|NCT00561912|Drug|Interferon Alfa-2b|0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one.
12003845|NCT00561899|Drug|SP, amodiaquine, piperaquine, dihdroartemisinin|once every month during september, October and November
12003846|NCT00561899|Drug|intermittent preventive treatment|SP(500mg sulfadoxine/25mg pyrimethamine)1.25mg SP per kg stat Amodiaquine (200mg base) 25mg/kg over 3 days Piperaquine (320 mg per tablet) 16.8 g/kg daily for 3 days Du-Cotecxin ( 40mg dihydroartemisinin(DHA)/320mg piperaquine(PQP))PQP/DHA 1.6/12.8mg/kg once daily for 3 days
12003847|NCT00561899|Drug|Du-Cotecxin|Du-Cotecxin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days
12003848|NCT00561886|Drug|Formoterol|One inhalation of 24µg Formoterol
12003849|NCT00561860|Device|Telemedicine Arm|Telemedicine involves the provision or support of direct clinical care via the application of electronic and communicating technology, including the remote monitoring of health status. By providing patient data early in the course of CPAP prescription, we believe that this technology would be immensely useful in improving compliance and acceptance of the device in patients with sleep apnea.
12003850|NCT00561834|Drug|ranibizumab|All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.
12003851|NCT00561821|Drug|Esmirtazapine|one tablet daily
12003852|NCT00561821|Drug|Placebo|one tablet daily
12003853|NCT00561808|Other|In-vitro maturation oocytes|Immature oocytes (development stage GV or M1) will be matured in-vitro in IVM culture medium for approximately 28-32 hours. The oocytes will be routinely observed and when they reach maturation (M2) they will be fertilized. The developed embryo will be transferred to the patient 24 hours post-fertilization.
12003854|NCT00561795|Drug|pazopanib (GW786034)|800 mg orally once a day for 6 cycles
12003855|NCT00561795|Drug|carboplatin|IV over one hour every 3 weeks of 6 cycles
12003856|NCT00561795|Drug|paclitaxel|IV 175 mg/m^2 given over 3 hours on day one of a 21 day cycle for six cycles
12003857|NCT00561769|Drug|Norditropin pen|12 IU per day
12003858|NCT00561756|Biological|plasmid DNA vaccine therapy|
12003859|NCT00561756|Other|flow cytometry|
12003860|NCT00561756|Other|immunoenzyme technique|
12003861|NCT00561743|Drug|Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone|
12003862|NCT00561730|Drug|Pantoprazole|Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).
12003863|NCT00561717|Drug|Azelastine and placebo|One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
12003864|NCT00561717|Drug|Loratadine and Placebo|One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
12003865|NCT00561717|Drug|Cetirizine and Placebo|One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
12003866|NCT00561717|Drug|Placebo and Placebo (spray and Tablet)|One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
12003867|NCT00561704|Drug|losartan|losartan, 100mg daily,
12003868|NCT00561691|Drug|nimotuzumab|monoclonal antibody
12003869|NCT00561678|Drug|Precedex (Dexmedetomidine)|0.5/ug/kg/hr Dexmedetomidine infusions will begin prior to the surgery (no loading dose), and will be maintained at 0.5 mcg/kg/hour throughout surgery and titrated postoperatively for 2 hours postoperatively.
12003870|NCT00561678|Drug|Placebo|0.5/ug/kg/hr Placebo infusions will begin prior to the surgery (no loading dose), and will be maintained at 0.5 mcg/kg/hour throughout surgery and titrated postoperatively for 2 hours postoperatively.
12003871|NCT00561652|Behavioral|Education & Exercise|Education & Exercise
12003872|NCT00561652|Procedure|Chiropractic treatment (plus Education & Exercise)|Chiropractic treatment (plus Education & Exercise)
12003873|NCT00561626|Dietary Supplement|high fat diet followed by low fat diet|High fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily Low fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily
12003874|NCT00561626|Dietary Supplement|low fat diet followed by high fat diet|Low fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily High fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily
12003875|NCT00561613|Other|SILCS and lubricant|
12003876|NCT00561613|Other|SILCS and spermicide|
12003877|NCT00561600|Device|ASR™-XL Modular Acetabular Cup System|The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.
12003878|NCT00561600|Device|Pinnacle™ acetabular shell|The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.
12003879|NCT00561587|Drug|Seroquel®|dosage form: oral, adjusted in the range of 25 to max. 300 mg /day
12003880|NCT00561574|Drug|Esmirtazapine|One tablet daily
12003881|NCT00561561|Behavioral|Acoustic startle testing|recording of eyeblink component of acoustic startle reflex with small surface electrodes during presentation of acoustic stimuli through headphones
12003885|NCT00561522|Drug|Capecitabine|Capecitabine 1,250 mg/m2 twice daily on days 1-14, followed by a 7-day drug-free interval. Treatment repeats every 21 days. The above cycle is repeated for 4-6 times.If disease recurrence or unacceptable toxicity or other criteria for withdrawal are met, treatment will be stopped.
12003886|NCT00561522|Other|No other preventive treatment|No other preventive treatment
12003887|NCT00561509|Drug|SSRIs|Use within normal clinical practice
12003888|NCT00561509|Drug|Dual antidepressants|Use within clinical practice
12003889|NCT00561496|Drug|Tenofovir gel|Intravaginal (4grams)single dose followed by fourteen days
12003890|NCT00561470|Drug|Placebo|4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks
12003891|NCT00561470|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.
12003892|NCT00561470|Drug|FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)|"The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1
~The FOLFIRI regimen included:
~180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
~5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
~5-FU 2400 mg/m² continuous IV infusion over 46-hours"
12003893|NCT00561470|Drug|FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)|"The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1
~The FOLFIRI regimen included:
~180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
~5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
~5-FU 2400 mg/m² continuous IV infusion over 46-hours"
12003894|NCT00561457|Device|Bard Luminexx Iliac Stent and Delivery System|Iliac Stenting
12003895|NCT00561444|Behavioral|Questionnaire|Questionnaires taking 20 minutes to complete.
12003896|NCT00561431|Device|Standard dose of dialysis|Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr
12003897|NCT00561431|Device|High dose of dialysis|Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr
12003898|NCT00561418|Drug|vorinostat|Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
12003899|NCT00561418|Other|Correlative studies|Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)
12003900|NCT00561405|Behavioral|Motor Learning Walking Program|Motor Learning principles based Walking Program (MLWP) Participants practice variety of real life over ground walking related activities. Order of practice, instructions, guidance and feedback are provided in a manner that facilitates cognitive engagement of learner. Sessions 45 minutes, 3x per week over 5 weeks for a total of 15 sessions
12003901|NCT00561405|Behavioral|Body Weight Supported Treadmill Training|Participants practice walking on a treadmill while supported with an overhead harness system. Up to 40% body weight support. Target Treadmill speed 2.0 mph. 1 or 2 Trainers (at least one Physical Therapist plus another Physical Therapist or Physiotherapy Assistant) will help guide participants leg, foot and trunk during treatment. Aim is to practice high numbers of repetition of the normal gait cycle on treadmill. Duration of sessions - 20 minutes of treadmill training within a 45 minute session ( 4 sets of 5 minutes of training with 5 minute rests). 3 sessions per week for 5 weeks. Total of 15 sessions.
12003902|NCT00561392|Drug|Rivastigmine 5 and 10 cm^2 patch|
12003903|NCT00561379|Drug|CHOP+RITUXIMAB|CHOP-14- Rituximab x 8 courses
12003904|NCT00561379|Drug|CEEP-RITUXIMAB|High dose chemotherapy with rituximab including autologous stem cell support.
12003905|NCT00561366|Drug|Placebo|Placebo t.i.d.
12003906|NCT00561366|Drug|Arimoclomol|capsule, 400 mg t.i.d.
12003907|NCT00561353|Drug|TMC435|TMC435 25 mg, 75 mg, 150 mg, or 200 mg capsules taken orally (by mouth) once daily for 21 or 28 days.
12003908|NCT00561353|Drug|Placebo|Placebo capsules identical in appearance to TMC435 capsules taken orally (by mouth) once daily for 28 days.
12003909|NCT00561353|Drug|Peginterferon (PegIFNα-2a)|One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFNα-2a on Days 1, 8, 15, and 22
12003910|NCT00561353|Drug|Ribavirin|200-mg tablets of ribavirin (body-weight adjusted dose) taken orally (by mouth) twice daily for 21 or 28 days in Cohorts 1 and 2 and for 28 days in Cohorts 4 and 5.
12003911|NCT00561340|Dietary Supplement|Pediasure|50% will be randomized to pediasure with nutritional counseling
12003912|NCT00561340|Behavioral|Nutritional counseling|50% randomized to nutritional counseling only
12003913|NCT00561327|Drug|losartan|Daily treated with losartan 100mg for at least the past 2 months (retrospective, no new drug treatment/ intervention)
12003914|NCT00561314|Other|questionnaire administration|
12003915|NCT00561314|Procedure|biopsy|
12003916|NCT00561314|Procedure|high-intensity focused ultrasound ablation|
12003917|NCT00561314|Procedure|magnetic resonance imaging|
12003918|NCT00561314|Procedure|quality-of-life assessment|
12003919|NCT00561301|Drug|GemDOx|gemcitabine oxliplatin
12003920|NCT00561288|Drug|acetaminophen|2 x 1000 mg doses per day
12003921|NCT00561288|Other|cornstarch|2 x 1000 mg cornstarch per day
12003922|NCT00561275|Biological|LY6K, VEGFR1, VEGFR2|1 mg/body every two week with GM-CSF, 4 cycles
12003923|NCT00561262|Other|questionnaire administration|
12003924|NCT00561262|Procedure|high-intensity focused ultrasound ablation|
12003925|NCT00561262|Procedure|quality-of-life assessment|
12003926|NCT00561249|Procedure|laser assisted hatching|Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo
12003927|NCT00561223|Drug|iloprost Inhalation|inhale 2.5 mg, repeat times one
12003928|NCT00561223|Drug|iloprost|inhaled 2.5 mg, repeat times one
12003929|NCT00561210|Dietary Supplement|Crucial|Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
12003930|NCT00561210|Dietary Supplement|Sondalis HP|Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
12003931|NCT00561197|Drug|AT-101|Patients will receive AT-101 starting at 10 mg once daily for 5 of 7 days in conjunction with RT (50.4 Gy for 28 fractions) for approximately 5.5 weeks. Concurrently, patients will receive docetaxel (20 mg/m2) IV weekly (Monday) and 5-fluorouracil (300 mg/m2) as a 24 hour continuous infusion for 5 of 7 days (Monday-Friday) of each RT week for approximately 5 weeks. Patients will continue for full 5.5 weeks unless unacceptable toxicity occurs.
12003932|NCT00561184|Biological|H5N1 influenza vaccine|One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen
12003933|NCT00561184|Biological|H5N1 influenza vaccine|One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen
12003934|NCT00561171|Drug|SPP635|oral once daily
12003935|NCT00561158|Behavioral|Eat Well Live Well Nutrition Program|"12 sessions (6 group and 6 individual)over a period of 3 months with a 3 month follow-up period. The group sessions involve active learning exercises crucial to learning and utilizing nutrition information.
~The group sessions included are:
~Rate Your Plate: determining high fat foods
~Label Reading: reading food labels
~Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income
~Recipe Modification: preparing old recipes in new ways to reduce fat
~Eating Out: order healthier fast foods
~Coping with High Risk Situations: coping with situations in which these new habits may be threatened
~Six individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including:
~Substituting fat-modified foods for high fat foods
~Avoiding fat as a seasoning or flavoring
~Avoiding fried foods
~Modifying meat
~Replacing high fat foods with fruits, vegetables, grains and breads"
12003936|NCT00561145|Other|Energy restriction period|The experiment can be divided in 3 phases, namely (1) run-in phase, (2) energy restriction phase and (3) ad libitum food intake phase. Thus, for all participants the experiment consists of three subsequent phases.
12003937|NCT00561132|Dietary Supplement|Vanadyl sulfate|50 mg twice daily orally for a period of 4 weeks
12003938|NCT00561132|Other|Magnesium oxide|Validation of similar appearance and weight to the intervention component orally 1 unit (<50 mg) twice daily for a period of 4 weeks
12003939|NCT00561119|Drug|gemcitabine , paclitaxel|"Gemcitabine 1250 mg/m2 i.v. Day 1 & 8
~Paclitaxel 175 mg/m2 i.v. day 1
~repeat every 3 weeks"
12003940|NCT00561106|Drug|prednisone- valacyclovir|prednisone, a dose of 1 mg/kg body weight was given daily for 7 days. The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days.
12003941|NCT00561106|Drug|prednisone-placebo|prednisone, a dose of 1 mg/kg body weight was given daily for 7 days
12003942|NCT00561093|Drug|pentoxiphylline|pentoxiphylline 400 mg daily, anti-inflammatory and appetite-stimulating while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
12003943|NCT00561093|Dietary Supplement|Nepro|Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
12003944|NCT00561093|Dietary Supplement|anti-inflammatory module (similar to Oxepa)|Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
12003945|NCT00561093|Drug|Placebo pill imitating pentoxiphylline|Placebo pill imitating pentoxiphylline 400 mg daily, to imitate the anti-inflammatory and appetite-stimulating pill while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
12003946|NCT00561093|Dietary Supplement|Placebo to imitate Nepro|Placebo to imitate Nepro (8 ounces), with less protein and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
12003947|NCT00561093|Dietary Supplement|Placebo to imitate anti-inflammatory module (similar to Oxepa)|Placebo to imitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients, while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
12003948|NCT00561080|Biological|Zostavax|
12003949|NCT00561067|Drug|Erythropoietin|EPO 500 IU/kg diluted in 50 ml saline and infused in 30 minutes; treatment is started within eight hours after the spinal injury; the same drug dosage will be infused at 24 and 48 hours
12003950|NCT00561067|Drug|Methylprednisolone|MP 30 mg/kg intravenous (iv) in the first hour, followed by 5.4 mg/kg/h for 23 hours if treatment is started within three hours after the spinal injury,or for 48 hours if treatment is started between three and eight hours (protocol NASCIS III, National Acute Spinal Cord Injury Study)
12003951|NCT00561054|Drug|CETUXIMAB|400 mg/m2 starting dose, 250 mg/m2 weekly dose
12003952|NCT00561041|Behavioral|Brief phone aftercare intervention|Interventions is composed of 5 integrated cognitive-behavioral and motivational enhancement therapies administered during a period of 3 months according to a similar schedule
12003953|NCT00561041|Behavioral|individual aftercare therapy|composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule
12003954|NCT00561028|Other|blood sample analysis - mycoplasma and chlamydia antibodies|Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).
12003955|NCT00561015|Drug|Telaprevir|Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
12003956|NCT00561015|Drug|Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)|Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
12003957|NCT00561015|Drug|Placebo|Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
12003958|NCT00561002|Biological|2007-2008 Influenza Virus Vaccine|0.25 mL, Intramuscular
12003959|NCT00561002|Biological|2007-2008 Influenza Virus Vaccine|0.25 mL, Intramuscular
12003960|NCT00560976|Drug|Iron Saccharate (Venofer)|Hemodialysis with IV iron administration of 100 mg Iron Saccharate (Venofer) in 150 ml 0.9 % saline to the arterial dialysis line during first hour of mid-week dialysis session. An alternative IV iron brand in some centers participating in the study could bebe 62.5 mg ferric gluconate (Ferrlecit).
12003961|NCT00560963|Drug|everolimus|
12003962|NCT00560950|Biological|pneumococcal 23v polysaccharide vaccine|Duration of Treatment: Single vaccination on Day 1
12003963|NCT00560937|Drug|Pregnenolone|Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks
12003964|NCT00560937|Drug|Placebo|Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks
12003965|NCT00560924|Drug|estradiol, 25 mcg|
12003966|NCT00560911|Behavioral|educational program for the self-management of OAC|"Patients in the self-management group participated in 4 consecutive weekly instruction sessions of 90 to 120 minutes each, in groups of 3 to 6 patients.
~After participation in the structured programme, the patients were encouraged to control their INR values by self-monitoring once a week and to adjust their anticoagulant dosage accordingly."
12003967|NCT00560911|Behavioral|1 hour education - afterwards physician leaded OAC control|"Patients in the routine control group participated a single 90-minute session
~During the whole study period, they were advised with regard to changes in the anticoagulant dosage by their usual attending physicians, either in general practice or at a hospital-based specialised anticoagulation clinic."
12003968|NCT00560898|Drug|ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
12003969|NCT00560898|Drug|Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
12003970|NCT00560898|Drug|Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
12003971|NCT00560898|Drug|ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
12003972|NCT00560885|Device|AtriCure Bipolar System|Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
12003973|NCT00560872|Device|remote magnetic catheter navigation|use of the Stereotaxis system
12003974|NCT00560872|Procedure|cavotricuspid isthmus ablation|conventional (manual) approach
12003975|NCT00560859|Procedure|Adenotonsillectomy (AT) - removal of adenoids and tonsils|Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils
12003976|NCT00560859|Other|Watchful Waiting|Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
12003977|NCT00560846|Dietary Supplement|Impact|Preoperative 5 day oral Impact and early post-operative enteral Impact
12003978|NCT00560846|Dietary Supplement|Glucose load|Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
12003979|NCT00560833|Drug|esmirtazapine|
12003980|NCT00560833|Drug|Placebo|
12003981|NCT00560820|Drug|Deferasirox|30 mg/kg/day
12003982|NCT00560807|Procedure|Mobilization|Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
12003983|NCT00560794|Biological|Blinatumomab (MT103)|Administered by continuous intravenous (CIV) over 4 weeks per cycle
12003984|NCT00560781|Drug|Pregnenolone or Placebo|Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID
12003985|NCT00560768|Device|Ovatio VR 6250 or DR6550|"The study requires the implantation of locally approved material:
~A right ventricular defibrillation lead
~In case of use of a dual chamber ICD a right atrial pacing lead
~A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study.
~Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar."
12003986|NCT00560755|Biological|ProQuad®|ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.
12003987|NCT00560742|Procedure|Control|Coronary artery bypass grafting without bone marrow cells injection
12003988|NCT00560742|Procedure|Intramuscular administration of bone marrow cells|Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar
12003989|NCT00560742|Procedure|Intracoronary administration of bone marrow cells|Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar
12003990|NCT00560729|Dietary Supplement|Renutryl 500|
12003991|NCT00560729|Dietary Supplement|Generique|
12003992|NCT00560729|Dietary Supplement|Generique + Renutryl 500|
12003993|NCT00560716|Drug|CYC116|Dose escalation of CYC116
12003994|NCT00560703|Drug|COL-101 (doxycycline, USP) capsules|40mg, once per day for 84 days
12003995|NCT00560703|Drug|placebo|sugar capsule
12003996|NCT00560690|Drug|Metformin|500 mg oral three times a day for 6 months
12003997|NCT00560690|Drug|pegylated interferon|180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
12003998|NCT00560690|Drug|Ribavirin|800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
12003999|NCT00560664|Procedure|Autologous chondrocytes transplantation|Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.
12004000|NCT00560664|Procedure|Mosaicoplasty|Osteochondral patch are sampled and then implanted during the same surgical procedure
12004001|NCT00560651|Procedure|CCL (Corneal Cross Linking)|Apply Riboflavin 0.1% in Dextran 500 20% in NaCl solution Illuminate with UV-light of 365 nm wave-length and 3.0 mW/cm² intensity at 5 cm distance
12004002|NCT00560638|Drug|loteprednol etabonate ophthalmic suspension, 0.5%|TID
12004003|NCT00560638|Drug|loteprednol etabonate ophthalmic suspension, 0.5%|QID
12004004|NCT00560638|Drug|vehicle of loteprednol etabonate|TID or BID according to the randomization
12004005|NCT00560612|Drug|Paroxetine|Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
12004006|NCT00560612|Drug|Placebo|Placebo: same as paroxetine (active comparator)
12004007|NCT00560599|Drug|mupirocin and chlorhexidine|"Mupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril.
~Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine."
12004008|NCT00560599|Behavioral|household cleaning and disinfection|Environmental cleaning with topical ethanol and laundering of clothes and linen.
12004009|NCT00560599|Drug|mupirocin, chlorhexidine, & household cleaning/disinfection|"Mupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril.
~Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine.
~Environmental cleaning with topical ethanol and laundering of clothes and linen."
12004010|NCT00560586|Drug|Budesonide|1 puff each nostril (32 micrograms) at bedtime
12004011|NCT00560586|Drug|placebo|1 puff each nostril at bedtime
12004012|NCT00560573|Drug|CP-751,871|CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year).
12004013|NCT00560573|Drug|Cisplatin|"Cisplatin 75* mg/m2 or 80* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles.
~* 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine"
12004014|NCT00560573|Drug|Gemcitabine|Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles
12004015|NCT00560573|Drug|Pemetrexed|Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle
12004016|NCT00560560|Biological|CP-751, 871|Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.
12004017|NCT00560547|Drug|methoxy polyethylene glycol-epoetin beta|120, 200 or 360 micrograms / 4 weeks iv (starting dose)
12004018|NCT00560534|Procedure|Whole body magnetic resonance angiography|Magnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs.
12004019|NCT00560521|Behavioral|CPAP|Frequency of three times a week, using a positive end expiratory pressure (PEEP) of 10 mmH2O for 30 minutes for four weeks.
12004020|NCT00560508|Drug|Pramipexole Immediate Release|titrated as individually needed (0.25 mg - 4.5 mg daily)
12004021|NCT00560508|Drug|Pramipexole Extended Release|titration as individually needed (0.375 mg -4.5 mg daily)
12004022|NCT00560495|Drug|ammonium tetrathiomolybdate|4 times daily for up to 3 weeks
12004023|NCT00560495|Other|immunoenzyme technique|
12004024|NCT00560495|Other|laboratory biomarker analysis|
12004025|NCT00560495|Radiation|Tc 99m sestamibi|
12004026|NCT00560495|Radiation|radiation therapy|once daily, 5 days a week, for 6-7 weeks
12004027|NCT00560482|Drug|ABR-215050, tasquinimod|Gelatin capsules containing 0.25mg, 0.50mg, 1.0mg ABR-215050; 0.25mg/day taken orally once daily for 2 weeks, 0.50mg/day taken orally once daily for 2 weeks (dose-titration), and 1.0 mg/day taken once daily for 5 months (+6 months continuation)
12004028|NCT00560482|Drug|Placebo|Identical appearing gelatin capsules containing placebo
12004029|NCT00560469|Other|Administration of 70% deuterated water|Subjects will drink 70% deuterated water daily for 8 weeks.
12004030|NCT00560456|Other|Chronic sleep restriction and driving simulator|"One night of normal sleep
~Driving simulator
~Night 1: night of total sleep deprivation
~Night 2: night of sleep recovery
~Night 1 to 5: nights of sleep restriction
~Driving simulator after night 1 to 5
~Night 6: night of sleep recovery
~Driving simulator"
12004031|NCT00560443|Drug|ketorolac|0,5 mg/kg per os one time
12004032|NCT00560443|Drug|tramadol|2,5 mg/ kg per os in one dose
12004033|NCT00560430|Drug|telmisartan|80 mg per day, orally, weeks 1-14
12004034|NCT00560430|Drug|telmisartan|80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
12004035|NCT00560430|Drug|placebo|placebo; orally weeks 1-14
12004036|NCT00560417|Drug|Insulin Lispro Protamine Suspension|Administered subcutaneously once a day at bedtime
12004037|NCT00560417|Drug|Insulin Glargine|Administered subcutaneously once a day at bedtime
12004038|NCT00560404|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms sc monthly (starting dose)
12004039|NCT00560404|Drug|Epoetin alfa|As prescribed
12004040|NCT00560391|Drug|Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg|Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
12004041|NCT00560391|Drug|Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg|Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
12004042|NCT00560391|Drug|Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg|Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
12004043|NCT00560391|Drug|Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg|Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
12004044|NCT00560391|Drug|Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg|Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.
12004045|NCT00560378|Drug|Tacrolimus ointment 0.1%|Topical
12004046|NCT00560365|Other|laboratory biomarker analysis|
12004047|NCT00560365|Procedure|computed tomography|
12004048|NCT00560365|Procedure|magnetic resonance imaging|
12004049|NCT00560365|Procedure|quality-of-life assessment|
12004050|NCT00560352|Drug|Dasatinib|Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD
12004051|NCT00560352|Drug|Bortezomib|Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m^2 QD, 1.3 mg/m^2 QD
12004052|NCT00560352|Drug|Dexamethasone|Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD
12004158|NCT00559676|Drug|irinotecan hydrochloride|
12004053|NCT00560326|Drug|Tacrolimus Ointment 0.03%|Once or twice daily topical application
12004054|NCT00560313|Biological|Men ACWY CRM|A single dose of a 0.5 mL injectable solution
12004055|NCT00560313|Biological|4CMenB|All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
12004056|NCT00560300|Drug|1 alpha D2|Vitamin D sterol
12004057|NCT00560300|Drug|1,25 dihydroxy vitamin D3|Active vitamin D sterol
12004058|NCT00560300|Drug|Sevelamer HCl|Phosphate binder
12004059|NCT00560300|Drug|Calcium Carbonate|Phosphate binder
12004060|NCT00560287|Device|Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers|A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
12004061|NCT00560287|Device|Non invasive ventilation|A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
12004062|NCT00560274|Drug|Pegasys|As prescribed
12004063|NCT00560274|Drug|Ribavirin|As prescribed
12004064|NCT00560274|Drug|epoetin beta [NeoRecormon]|30,000 IU sc/week (starting dose)
12004065|NCT00560261|Other|NO-CO inhalation and expiration|NO-CO inhalation and expiration
12004066|NCT00560261|Other|NO-CO inhalation and expiration|NO-CO inhalation and expiration
12004067|NCT00560235|Drug|CP-751,871|Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity
12004068|NCT00560222|Dietary Supplement|bovine lactoferrin|1gm of lactoferrin will be given each day
12004069|NCT00560222|Dietary Supplement|placebo [maltodextrin]|placebo that appears identical to lactoferrin will be given daily
12004070|NCT00560209|Drug|ONO-1101|placebo for 1 minute IV
12004071|NCT00560209|Drug|ONO-1101|0.06 mg/kg for 1 minute IV
12004072|NCT00560209|Drug|ONO-1101|0.125 mg/kg for 1 minute IV
12004073|NCT00560196|Other|Observation|
12004074|NCT00560183|Drug|Q8003 (morphine sulfate and oxycodone hydrochloride)|Capsules, four different mg dosage strengths
12004075|NCT00560183|Drug|Placebo|Capsules
12004076|NCT00560170|Drug|Simvastatin (Zocor)|40mg of Simvastatin (n=20) orally per-day for 28 days
12004077|NCT00560170|Drug|10mg/10mg of Ezetimibe/Simvastatin (Vytorin)|10mg/10mg of Ezetimibe/Simvastatin (n=20) orally per-day for 28 days
12004078|NCT00560157|Dietary Supplement|Crucial (enteral tube feeding)|Evaluation of new enteral product, Crucial, in ICU patients
12004079|NCT00560144|Drug|RG1507|3mg/kg iv weekly
12004080|NCT00560144|Drug|RG1507|9mg/kg iv weekly
12004081|NCT00560144|Drug|RG1507|Pharmacokinetic-derived dose, <=16mg/kg iv weekly
12004082|NCT00560118|Drug|fotemustine|
12004083|NCT00560118|Genetic|gene expression analysis|
12004084|NCT00560118|Genetic|polymerase chain reaction|
12004085|NCT00560105|Device|Lung Flute|8 weeks home use, twice daily
12004086|NCT00560105|Device|Acapella|8 weeks home use, twice daily
12004087|NCT00560092|Drug|intrathecal magnesium sulfate|intrathecal magnesium sulfate
12004088|NCT00560079|Drug|Allopurinol|Allopurinol 600mg/day bid for 28 days
12004089|NCT00560079|Drug|Dipyridamole|Dipyridamole 200mg/day bid for 28 days
12004090|NCT00560079|Drug|Placebo|Placebo
12004091|NCT00560066|Biological|Cell-derived influenza vaccine|1 dose of 0.5 mL in the deltoid region of the non-dominant arm
12004092|NCT00560066|Biological|Egg-derived influenza vaccine|1 dose of 0.5 mL in the deltoid region of the non-dominant arm
12004093|NCT00560053|Drug|Alternating chemotherapy|"4 cycles of alternating chemotherapy VBMCP/VBAD (every 5 weeks). VBMCP: Vcr 2 mg ev day 1, BCNU 0.5 mg/kg ev day 1, Cyclophosphamide 10 mg/kg day 1, Melphalan 0.25 mg/kg v.o. days 1-4, Prednisone 1 mg/kg v.o. days 1-4, 0.5 mg/kg days 5-8 and 0.25 mg/kg days 9-12.
~VBAD: Vcr 1 mg e.v. day 1, BCNU 30 mg/m 2 e.v. day 1, Adriamycine 40 mg/m 2 day 1, Dexamethasone 40 mg/m 2 days 1-4, 9-12 and 17-20."
12004094|NCT00560053|Procedure|Autologous Transplantation|"Autologous Transplantation :
~BUMEL:Busulfan, total dose 12 mg/kg (days -6 a -3; prophylaxis with difenilhidantoine) Melphalan 140 mg/m 2 , ev day -2 TASPE: To investigator criteria"
12004095|NCT00560053|Drug|Maintenance|"At 3 months of transplantation or with >1.500 neutrophiles/ > 75.000 platelets mm 3 .
~Prednisone: 50 mg alternating days during 2 years Interferon alfa 2-b: 3 M UI s.c. Three times a week until relapse."
12004096|NCT00560053|Procedure|Second transplantation|In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .
12004097|NCT00560053|Procedure|ALOGENIC MINI TRASPLANTATION|ALOGENIC MINI TRASPLANTATION Fludarabine 30 mg / m 2 / day, days -7, -6, -5, -4, -3 Melphalan 70 mg / m 2 / day, day -2 Prophylaxis EICH: CsA + MTX or CsA + MOFETIL
12004098|NCT00560027|Other|Case Management by Family Support Counselor (not RCT)|N/A. Had planned to study RCT of case management intervention but unable to carry out RCT. Instead studied screening practice and healthcare utilization in mothers with PPD, IPV or both.
12004099|NCT00560014|Dietary Supplement|Arginine and canola oil|Canola oil 1 tablespoon BID Arginine 9.0grams BID
12004100|NCT00560014|Dietary Supplement|Coromega and Arginine|Arginine 9.0 grams BID Coromega dose based on weight
12004101|NCT00560001|Behavioral|MD.2 Medication Dispenser|For those subjects receiving an MD.2 Medication Dispenser, the machine organizes medications and provides verbal and auditory explicit reminders for individuals to take their medications. At the scheduled time, the patient gets a series of reminders. The patient is then expected to push a single button to dispense a pre-filled medication cup. An automatic record is kept of the subject's medication adherence. Interviewer-administered surveys of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits will be given. Caregivers will complete the Caregiver Burden Interview.
12004159|NCT00559676|Drug|leucovorin calcium|
12004160|NCT00559676|Drug|oxaliplatin|
12004161|NCT00559676|Other|laboratory biomarker analysis|
12004102|NCT00559988|Drug|Home Monitoring Guided OAC|"Active monitoring for atrial episodes through the automatic HM notifications (email, fax, short message service) is required. If the total duration over 48 consecutive hours reaches the predefined anticoagulation condition, and AF/AFL diagnosis is confirmed using the IEGM online, the site instructs the patient by telephone to start OAC. Clinicians continue to monitor patients using HM, and if freedom from AF/AFL reaches the predefined interval, stop of OAC therapy is requested over the telephone. Following stop of anticoagulation, any recurrence of AF/AFL requires restart of OAC therapy.
~OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA"
12004103|NCT00559988|Drug|Physician-Directed OAC|"Patients will receive physician-directed anticoagulation therapy based on conventional criteria.
~OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA"
12004104|NCT00559975|Biological|Subunit influenza vaccine|0.5 mL single dose vaccine
12004105|NCT00559975|Biological|Adjuvanted influenza vaccine|0.5 mL single dose vaccine
12004106|NCT00559975|Biological|Adjuvanted influenza vaccine combined with CpG7909|0.5 ml influenza vaccine combined with 10 mcg of CpG7909
12004107|NCT00559975|Biological|Adjuvanted influenza vaccine combine with CpG7909|0.5 mL single dose vaccine combined with 30 mcg of CpG7909
12004108|NCT00559975|Biological|Adjuvanted influenza vaccine combine with CpG7909|0.5 mL single dose vaccine combined with 100 mcg of CpG7909
12004109|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
12004110|NCT00559962|Drug|placebo|3 capsules each evening for each 4-week period
12004111|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
12004112|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
12004113|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
12004114|NCT00559962|Drug|AEGR-733 and atorvastatin|3 capsules each evening for each 4-week period
12004115|NCT00559962|Drug|AEGR-733 and fenofibrate|3 capsules each evening for each 4-week period
12004116|NCT00559962|Drug|AEGR-733 and ezetimibe|3 capsules each evening for each 4-week period
12004117|NCT00559949|Other|Laboratory Biomarker Analysis|Correlative studies
12004118|NCT00559949|Drug|Selumetinib|Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary.
12004119|NCT00559936|Drug|Topical Avastin 1%|Avastin (bevacizumab) 1%
12004120|NCT00559910|Drug|PH-797804|PH-797804 at four dose levels
12004121|NCT00559910|Drug|Placebo|Placebo
12004122|NCT00559897|Other|3'-deoxy-3'-[18F]FLT|Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
12004123|NCT00559897|Procedure|Single photon emission computed tomography|Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
12004124|NCT00559884|Drug|GSK189075 (Modified and immediate release formulations)|
12004125|NCT00559871|Drug|fipamezole|Fipamezole in Zydis formulation three times per day for up to 28 days
12004126|NCT00559858|Dietary Supplement|pyridoxine hydrochloride|
12004127|NCT00559858|Other|placebo|
12004128|NCT00559858|Procedure|quality-of-life assessment|
12004129|NCT00559845|Drug|5-fluorouracil|600 milligrams per meter squared (mg/m^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
12004130|NCT00559845|Drug|Epidoxorubicin|90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
12004131|NCT00559845|Drug|Cyclophosphamide|600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
12004132|NCT00559845|Drug|Paclitaxel|Paclitaxel was administered at 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.
12004133|NCT00559845|Biological|Bevacizumab|Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
12004134|NCT00559832|Other|Hypoxic Exposure|Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m
12004135|NCT00559819|Drug|placebo|Placebo (orange juice), same volume as alcohol
12004136|NCT00559819|Drug|Alcohol|Dose with Alcohol (Vodka) to make blood alcohol concentration 0.08%
12004137|NCT00559806|Other|2 weeks of unilateral immobilisation and 4 weeks of resistance training|2 weeks of whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control
12004138|NCT00559806|Other|2 weeks of unilateral immobilisation and 4 weeks of resistance training|2 weeks of unilateral whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control
12004139|NCT00559780|Behavioral|Resistance training|12 weeks of resistance training (3/week)
12004140|NCT00559780|Behavioral|Neuromuscular electrical stimulation of the quadriceps muscle|12 weeks of neuromuscular electrical stimulation of the quadriceps muscle (1h/day)
12004141|NCT00559780|Behavioral|Standard rehabilitation|12 weeks of standard physiotherapy exercises (1h/day)
12004142|NCT00559754|Drug|bevacizumab [Avastin]|15mg/kg iv on day 1 of each 3 week cycle
12004143|NCT00559754|Drug|Docetaxel|75mg/m2 iv on day 1 of each 3 week cycle
12004144|NCT00559754|Drug|Standard chemotherapy|As prescribed
12004145|NCT00559741|Biological|cetuximab|
12004146|NCT00559741|Drug|fluorouracil|
12004147|NCT00559741|Drug|irinotecan hydrochloride|
12004148|NCT00559741|Drug|leucovorin calcium|
12004149|NCT00559741|Other|pharmacological study|
12004150|NCT00559715|Drug|bevacizumab|1.25 mg intravitreally monthly/on demand
12004151|NCT00559715|Drug|ranibizumab|0.5 mg intravitreally monthly/on demand
12004152|NCT00559702|Drug|natalizumab|natalizumab
12004153|NCT00559702|Other|standard of care|standard of care as determined by the Investigator and Treating Neurologist
12004154|NCT00559689|Drug|Budesonide,hydrofluoroalkane-beclomethasone dipropionate|receive twice-daily administration
12004155|NCT00559689|Drug|Budesonide,hydrofluoroalkane-beclomethasone|once-daily administration at bedtime
12004156|NCT00559676|Drug|capecitabine|
12004157|NCT00559676|Drug|fluorouracil|
12004163|NCT00559663|Dietary Supplement|Green tea|"The green tea group consumed first daily one liter of green tea infusate made of 4 bags left in boiling water during 3 minutes.
~After a four week washout-time they were switched over to the dark chocolate treatment, which included consumption of 3.5 ounces 70% dark chocolate.
~Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels"
12004164|NCT00559663|Dietary Supplement|70% dark chocolate|"The dark chocolate group consumed 3.5 ounces 70% dark chocolate per day during a one week period.
~After a four week washout-time they were given the green tea treatment, which included ingestion of one liter green tea infusate (containing 4 green tea bags).
~Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels."
12004165|NCT00559650|Drug|Placebo|Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
12004166|NCT00559650|Drug|Cinaciguat (BAY58-2667)|Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
12004167|NCT00559637|Drug|Methoxy polyethylene glycol-epoetin beta|Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
12004168|NCT00559624|Drug|Acadesine|For part I of the study one 4 hour intravenous infusion will be given. In part II upto five 4 hour intravenous infusions will be given over 20 days.
12004169|NCT00559611|Procedure|Endobronchial Ultrasound|A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.
12004170|NCT00559611|Procedure|Mediastinoscopy|Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.
12004171|NCT00559598|Genetic|proteomic profiling|
12004172|NCT00559598|Other|medical chart review|
12004173|NCT00559585|Drug|Subcutaneous (SC) Abatacept|Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
12004174|NCT00559585|Drug|Intravenous (IV) Abatacept|"Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
~500mg (for body weight up to 60 kg)
~750 mg (body weight between 61 and 100 kg)
~1g (body weight above 100 kg)infusions"
12004175|NCT00559572|Behavioral|Motivational group sessions|Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.
12004176|NCT00559572|Other|Time and attention control group sessions|Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.
12004177|NCT00559559|Device|ICD implant + Patient Notifier turned OFF|ICD implant, plus standard care, i.e. Patient Notifier turned off
12004178|NCT00559559|Procedure|ICD Implant + Patient Notifier turned ON|ICD implant. The Patient Notifier™ feature will be turned ON.
12004179|NCT00559546|Drug|montelukast|10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
12004180|NCT00559533|Drug|RO5045337|Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)
12004181|NCT00559520|Dietary Supplement|Impact|"Patient receiving 3 drinks Impact a day during 5 days before surgery"
12004182|NCT00559520|Dietary Supplement|Oral Impact|"Patient receiving 3 drinks Oral Impact a day during 5 days before surgery"
12004183|NCT00559507|Drug|saracatinib|
12004184|NCT00559507|Other|laboratory biomarker analysis|Correlative studies
12004185|NCT00559494|Drug|Minocycline|Minocycline IV BID x 7 days (first 10 patients 200 mg/dose, subsequent patients adjusted based on pharmacodynamic profiling to 800 mg loading dose, tapered 100 mg each dose to 400 mg then maintain at 400mg until day 7)
12004186|NCT00559494|Drug|placebo|Normal saline 250cc via central line similar to minocycline arm administration protocol
12004187|NCT00559494|Procedure|SCPP augmentation|maintenance of spinal cord perfusion pressure at 75 mmHg with fluids and inotrope protocol
12004188|NCT00559494|Procedure|SCPP control|maintenance of Mean arterial pressure of >65 mmHg with fluids and inotropes protocol without spinal cord perfusion pressure as target or guiding therapy
12004189|NCT00559481|Drug|dexamethasone|
12004190|NCT00559481|Drug|ketoconazole|
12004191|NCT00559481|Drug|therapeutic hydrocortisone|
12004192|NCT00559481|Procedure|pharmacological study|
12004193|NCT00559468|Drug|Sugammadex|Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium
12004194|NCT00559468|Drug|Rocuronium|Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium
12004195|NCT00559468|Drug|Sevoflurane|Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.
12004196|NCT00559468|Drug|Propofol|Propofol IV administered for induction and maintenance of anesthesia, based on randomization.
12004197|NCT00559455|Drug|Oxaliplatin|85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks
12004198|NCT00559455|Drug|Fluorouracil|400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks
12004199|NCT00559455|Drug|Leucovorin|200mg/m², Day 1 and Day 2; Every 2 weeks
12004200|NCT00559442|Other|Altitude Exposure:|rapid ascent to Margherita Hut (4559 m) within 24 h
12004201|NCT00559429|Drug|Docetaxel|Docetaxel 50mg/m2 IV on day 1 and day 22
12004202|NCT00559429|Drug|Docetaxel|Docetaxel 75mg/m2 IV on day 1 and day 22
12004203|NCT00559429|Drug|Docetaxel|Docetaxel 75mg/m2 IV on day 1 and day 22
12004204|NCT00559429|Drug|Docetaxel|Docetaxel 75 mg/m2 IV on day 1, 22 and day 43
12004205|NCT00559416|Drug|Cell Transfer|
12004240|NCT00559130|Device|CytoSorb Hemoperfusion|Daily hemoperfusion for 6 hours with CytoSorb device
12004241|NCT00559117|Drug|VB-111|A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute
12004242|NCT00559104|Drug|carmustine|Unique to the Carmustine in Conditioning arm
12004243|NCT00559104|Drug|cyclophosphamide|Used in Both Arms
12004206|NCT00559403|Behavioral|HIV/STD Risk-Reduction|Let Us Protect Our Future consists of twelve 1-hour sessions to increase knowledge, motivation, and skills in practicing abstinence and condom use. It is highly structured, and Xhosa-speaking male and female co-facilitators implement the program using standardized manuals. Treatment sessions include mixed-gender and single-gender activities, games, brainstorming, and role-playing. Comic workbooks are used to address abstinence, condom use, and how risky behavior affects goals and dreams. The Xhosa culture is taken into account, including cultural transformations in urban township settings. Take-home assignments enlist parents' help to empower their children to reduce their STD risk and ensure that parents are aware of the nature of the treatment program.
12004207|NCT00559403|Behavioral|Health Promotion|The health promotion treatment is structurally similar to the HIV/STD treatment: each has the same number of sessions and sessions led by Xhosa-speaking male and female co-facilitators. It focuses on behaviors linked with risk of heart disease, diabetes, high blood pressure, certain cancers, and alcohol and drug abuse, which are all leading causes of morbidity and mortality among South Africans. Participants are taught that healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance use, can prevent these health problems. Comic workbook story lines are used to increase risk perception and awareness of health risks. Take-home assignments are used to foster communication with parents about healthful lifestyle.
12004208|NCT00559377|Other|18F-fluoromisonidazole|Undergo ^18F FMISO PET scan
12004209|NCT00559377|Radiation|fluorodeoxyglucose F 18|Undergo ^18F FDG PET scan
12004210|NCT00559377|Procedure|positron emission tomography|Undergo ^18F-FMISO and ^18F FDG PET scan
12004211|NCT00559377|Other|tissue oxygen measurement|Undergo ^18 F FMISO PET and ^18F FDG PET
12004212|NCT00559364|Drug|Viokase® 16|Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.
12004213|NCT00559364|Drug|Placebo|Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.
12004214|NCT00559364|Drug|Proton pump inhibitor (PPI)|Patients on PPI during Screening will continue their usual PPI therapy throughout the study.
12004215|NCT00559364|Drug|Omeprazole|Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.
12004216|NCT00559351|Procedure|transthoracic esophagectomy 2-field extended lymphadenectomy|right thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck
12004217|NCT00559351|Drug|neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)|21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval
12004218|NCT00559351|Radiation|neoadjuvant chemoradiotherapy|21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 with concurrent external beam fractionated irradiation to a total dose of 30Gy (2Gy fractions on days 1-5, 8-12, 15-19) followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval
12004219|NCT00559338|Drug|recombinant B-type, natriuretic peptide|The intravenous infusion of nesiritide consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The nesiritide was mixed in 250 ml of 0.9% normal saline solution.
12004220|NCT00559338|Drug|placebo|The intravenous infusion of placebo consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The placebo was mixed in 250 ml of 0.9% normal saline solution.
12004221|NCT00559312|Drug|fluticasone/salmeterol combination|Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration
12004222|NCT00559312|Drug|placebo|Placebo Diskus inhaler, twice daily, 6-week duration
12004223|NCT00559299|Drug|GSK163090|
12004224|NCT00559286|Drug|Telmisartan|application of 80mg or 20mg Telmisartan per day for 30 days
12004225|NCT00559273|Drug|Methoxy polyethylene glycol-epoetin beta|1.2 mcg/kg SC monthly, starting dose
12004226|NCT00559273|Drug|Darbepoetin alfa|0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
12004227|NCT00559260|Device|Passive monitoring with pulse-oximetry, NIBP and ECG|
12004228|NCT00559247|Drug|BMS-650032 or Placebo|Oral, Once daily, Single Dose
12004229|NCT00559221|Drug|FLAG+IDA|Fludarabine, cytarabine, G-CSF
12004230|NCT00559195|Biological|epoetin beta|
12004231|NCT00559195|Procedure|quality-of-life assessment|
12004232|NCT00559182|Drug|Comparator: MK-8033|"MK-8033 will be administered as an oral formulation in sequentially rising dose levels starting at 50 mg and continuing at 100% dose increments until dose level 4 (800 mg total daily dose). Dose levels 5 to 11 will be escalated at ~40% dose increments until 3000mg (total daily dose). The daily dose of MK-8033 will be divided into two equal doses. MK-8033 will be administered in a first cycle of 14 days (continuous drug administration from Day 1 through Day 14), followed by a 1 week drug holiday (Cycle 1, Day 15 through Day 21). Subsequent cycles of MK-8033 will be administered for 14 days (Cycles 2 to 4) and 28 days (Cycle 5 and beyond).
~Enrollment in Parts A and B has been completed."
12004233|NCT00559182|Drug|Comparator: MK-8033 +/- omeprazole|"Part C will occur at only one of the investigational sites.
~In Cycle 1, patients will be randomized to one of two treatment sequences, A/B or B/A, over two treatment periods. Treatment A: 770 mg MK-8033 twice daily with co-administration of 20 mg omeprazole once daily. Treatment B: 770 mg MK-8033 twice daily. After Cycle 1 is complete, patients may continue to receive MK-8033 until disease progression or unacceptable toxicity.
~Enrollment for Part C has been suspended."
12004234|NCT00559169|Drug|verapamil hyrochloride|80 mg daily by mouth, 5 days prior to menses for 3 months
12004235|NCT00559156|Dietary Supplement|arginine/omega-3 fatty acids/nucleotides oral supplement|
12004236|NCT00559156|Drug|cisplatin|
12004237|NCT00559156|Procedure|adjuvant therapy|
12004238|NCT00559156|Radiation|radiation therapy|
12004239|NCT00559143|Other|Biventricular Pacing (DDD(R)- BiV)|Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV
12004244|NCT00559104|Drug|etoposide|Used in Both Arms
12004245|NCT00559104|Procedure|autologous hematopoietic stem cell transplantation|Both arms are given autologous stem cell transplantation
12004246|NCT00559104|Procedure|peripheral blood stem cell transplantation|Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).
12004247|NCT00559104|Radiation|total-body irradiation|Unique to the Radiation in Conditioning Arm
12004248|NCT00559104|Drug|G-CSF|G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
12004249|NCT00559091|Drug|ribavirin|Ribavirin will be administered orally, twice daily, in the morning and evening with food. The dose selected is 400 mg AM and 600 mg PM. Intrapatient dose escalations can also be performed in defined circumstances. The maximal dose administered will be 1000 mg AM and 1000 mg PM.
12004250|NCT00559078|Other|Interview|Hour-long, qualitative, phone interview
12004251|NCT00559052|Drug|VIOKASE 16|The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.
12004252|NCT00559039|Other|questionnaire administration|
12004253|NCT00559039|Procedure|evaluation of cancer risk factors|
12004254|NCT00559026|Biological|Melan-A|i.d. injections of Melan-A: 26-35 (A27L) and gp100: 209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. injection of 3MU IFN-α, as an adjuvant on day 1 and 8 every 21 days for a total of 5 courses
12004255|NCT00559026|Other|Melan-A plus Dacarbazine|Dacarbazine plus vaccine: the vaccination schedule as in arm 1 was combined with DTIC (800 mg/mq i.v.) administered one day before each vaccine administration according to the standard treatment.
12004256|NCT00559013|Device|Staple line reinforcement|Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.
12004257|NCT00559000|Behavioral|KIDNET|Narrative Exposure Therapy for Children
12004258|NCT00558987|Behavioral|Discipline Video|"The discipline video will be shown to the caregiver before the visit while they are waiting to see the doctor. The video gives specific guidance on avoiding physical discipline, setting consistent, safe and age appropriate limits.
~A copy of the discipline video and the handout reinforcing the messages presented in the video will be given to the caregiver by the research staff to share with other caregivers."
12004259|NCT00558987|Behavioral|Nutrition Video|A brief educational video on nutrition information, a topic not related to discipline.
12004260|NCT00558961|Drug|Gleevec and Chlorambucil|The first cohort will receive Gleevec at 300 mg daily on days 1-10 and chlorambucil 8mg/m2/d from day 3-7. This will be repeated every 28 days. Cohort 2 will receive 400 mg Gleevec and Cohort 3 will receive 600 mg Gleevec. Each dose level may be expanded up to 6 patients if 1 of 3 patients experiences any dose limiting toxicities.
12004261|NCT00558935|Dietary Supplement|Red Wine|20g alcohol daily/red wine for 4 weeks
12004262|NCT00558922|Drug|AEG35156|AEG35156 will be given as a 2-hour intravenous infusion once weekly with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1.
12004263|NCT00558909|Drug|BI 44847|
12004264|NCT00558909|Drug|placebo for BI 44847|
12004265|NCT00558896|Drug|dexamethasone|40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
12004266|NCT00558896|Drug|pomalidomide|2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
12004267|NCT00558883|Drug|acarbose|oral application
12004268|NCT00558870|Drug|Morphine|"Arm 1: 2 Doses of Slow-Release Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days).Immediate-release morphine may be used, if needed, for pain."
12004269|NCT00558870|Drug|Methadone|"1 Dose of Methadone PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days)
~Arm 2: 1 Dose of Slow-Release Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days).).Immediate-release morphine may be used, if needed, for pain."
12004270|NCT00558857|Device|Dynamic Substrate Mapping-guided ablation|Radiofrequency ablation
12004271|NCT00558844|Drug|Arikayce™ 560 mg|"Arikayce™ at 560 mg
~Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 2:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer."
12004272|NCT00558844|Drug|Placebo for 560 mg|"Matching placebo
~Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 2:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer."
12004273|NCT00558844|Drug|Arikayce™ 70 mg|Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
12004274|NCT00558844|Drug|Arikayce™ 140 mg|Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
12004275|NCT00558844|Drug|Placebo for 70 mg / 140 mg|"Matching placebo
~Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer."
12004276|NCT00558831|Drug|Benzoyl Peroxide|Benzoyl Peroxide 2.5%
12004277|NCT00558831|Drug|Moisturizing Lotion|
12004278|NCT00558818|Drug|Clevudine|clevudine 30 mg qd
12004279|NCT00558805|Behavioral|FISP + Usual Care|
12004280|NCT00558805|Behavioral|Usual Care|
12004281|NCT00558792|Drug|Isovue 370, 70 mL|70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
12004282|NCT00558792|Drug|Isovue 370, 80 mL|80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
12004283|NCT00558792|Drug|Isovue 370, 90 mL|90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
12004284|NCT00558779|Procedure|OBCAB (Off Pump Coronary Artery Bypass Grafting)|OPCAB with sparing of aortic manipulation (eg, no aortic cannulation for cardiopulmonary bypass, no aortic cross-clamp, no side-clamping of the aorta). Graft anastomosis to the central circulation with y-grafts on the arteria thoracica interna or on the aorta with help of the Heart-string-system (Guidant)
12004285|NCT00558779|Procedure|CABG (coronary artery bypass grafting)|conventional CABG with cardiopulmonary bypass
12004286|NCT00558753|Drug|pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
12004287|NCT00558753|Drug|Placebo|Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.
12004288|NCT00558740|Other|high protein intake|acute high protein intake chronic (6-day) high protein intake acute+chronic high protein intake control
12004289|NCT00558727|Drug|RH-1|1.5 mg/m2 to 12 mg/m2, depending on protocol cohort, administered via intravenous (IV) infusion over 3 hours once every 21 days.
12004290|NCT00558701|Device|Microcurrent stimulator|Microcurrent stimulation from 15-50 microamps
12004291|NCT00558701|Device|Silverlon Wound Contact Dressing|Silver coated nylon dressing FDA approved for use on donor sites in burn patients
12004292|NCT00558688|Procedure|Photodynamic therapy|Photodynamic therapy applied to actinic keratoses
12004293|NCT00558675|Biological|AlloStim|single intravenous infusion of 1 x 10^9 AlloStim cells
12004294|NCT00558675|Biological|AlloStim|Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7
12004295|NCT00558675|Biological|AlloStim|Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7 and day 14
12004296|NCT00558675|Biological|AlloStim|Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7, day 14 and day 21
12004297|NCT00558662|Device|Coban 2|Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.
12004298|NCT00558662|Device|SSB|Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.
12004299|NCT00558649|Biological|Flu Vaccine (FLUARIX®)|Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula
12004300|NCT00558636|Drug|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
12004301|NCT00558636|Drug|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
12004302|NCT00558623|Dietary Supplement|calcium carbonate|daily supplement of 1,200 milligrams calcium (two-600 mg tablets calcium carbonate at bedtime)
12004303|NCT00558584|Device|protein A immunoadsorption|protein-A immunoadsorption and i.v. IgG substitution
12004304|NCT00558584|Device|pseudo-immunoadsorption|pseudo-immunoadsorption followed by an intravenous infusion without IgG
12004305|NCT00558571|Drug|BI 10773 low dose|
12004306|NCT00558571|Drug|placebo to BI 10773|
12004307|NCT00558571|Drug|BI 10773 medium dose|
12004308|NCT00558571|Drug|BI 10773 high dose|
12004309|NCT00558558|Drug|Haelan|4 oz orally twice daily for 8 Weeks
12004310|NCT00558545|Drug|AEG35156|AEG35156 will be given as a 2-hour intravenous infusion once weekly only on weeks when paclitaxel is administered, with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1.
12004311|NCT00558532|Procedure|Bariatric Surgery|Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery
12004312|NCT00558519|Drug|cyclophosphamide|
12004313|NCT00558519|Drug|cytarabine|
12004314|NCT00558519|Drug|daunorubicin hydrochloride|
12004315|NCT00558519|Drug|dexamethasone|
12004316|NCT00558519|Drug|doxorubicin hydrochloride|
12004317|NCT00558519|Drug|mercaptopurine|
12004318|NCT00558519|Drug|methotrexate|
12004319|NCT00558519|Drug|pegaspargase|
12004320|NCT00558519|Drug|thioguanine|
12004321|NCT00558519|Drug|vincristine sulfate|
12004322|NCT00558519|Radiation|radiation therapy|
12004323|NCT00558506|Drug|abatacept|intravenously 750mg (in patients with weight of 60- 100kg)
12004324|NCT00558493|Drug|Clevudine|clevudine 30 mg qd for 24 seeks
12004325|NCT00558480|Drug|Vitamin A|Vitamin A capsules, as retinol palmitate 200,000 IU at enrollment, 3 and 6 months
12004326|NCT00558480|Drug|Vitamin A placebo|Vitamin A placebo at enrollment, 3 and 6 months
12004327|NCT00558467|Drug|pramipexole immediate release (IR)|
12004328|NCT00558467|Drug|Placebo|
12004329|NCT00558454|Drug|Iron|Ferrous succinate mixture
12004330|NCT00558441|Device|IVMRI|Intra Vascular Magnetic Resonance Imaging
12004331|NCT00558428|Drug|fixed dose combination of telmisartan+amlodipine|
12004332|NCT00558428|Drug|amlodipine|
12004333|NCT00558402|Behavioral|Meditation|meditation class 1/week for 8 weeks
12004334|NCT00558402|Behavioral|Education|Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers
12004335|NCT00558402|Behavioral|Respite only|Respite care 90 mins per week for 8 weeks
12004336|NCT00558376|Drug|polyethylene glycol|Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy
12004337|NCT00558376|Drug|Sodium phosphate|Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy
12004338|NCT00558363|Drug|Avodart|0.5 mg administered orally once daily
12005056|NCT00553202|Drug|methylprednisolone|Given IV
12004339|NCT00558363|Other|placebo|Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo
12004340|NCT00558337|Drug|levodopa-carbidopa|novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation
12004341|NCT00558324|Procedure|LASIK|Mechanical microkeratome Hansatome 160 microns
12004342|NCT00558324|Procedure|LASIK|Mechanical microkeratome K 3000 130 microns
12004343|NCT00558324|Procedure|LASIK|Femtoseconds laser 100 microns
12004344|NCT00558311|Drug|Clazosentan|Intravenous clazosentan administered by continuous infusion at 5 mg/h
12004345|NCT00558311|Drug|Placebo|Placebo administered by continuous infusion matching clazosentan administration
12004346|NCT00558298|Drug|risperidone|
12004347|NCT00558285|Drug|indacaterol/glycopyrrolate|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
12004348|NCT00558285|Drug|indacaterol|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
12004349|NCT00558285|Drug|glycopyrrolate|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
12004350|NCT00558285|Drug|placebo|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
12004351|NCT00558272|Drug|AZD0530|Daily oral dose
12004352|NCT00558272|Drug|Zoledronic Acid|
12004353|NCT00558259|Drug|dabigatran etexilate 150 mg twice daily (BID)|dabigatran etexilate capsules 150 mg BID
12004354|NCT00558259|Drug|matching placebo twice daily (BID)|Matching placebo BID
12004355|NCT00558246|Device|Dermabond Protape (Prineo)|cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
12004356|NCT00558246|Device|Suture|Topical Suturing
12004357|NCT00558233|Behavioral|CHOICE decision aid|computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit
12004358|NCT00558233|Behavioral|YourMeds patient education program|computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit
12004359|NCT00558220|Procedure|immunotherapy|"Given together with induction chemotherapy:
~Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses"
12004360|NCT00558220|Procedure|Induction treatment part 1|"cyclophosphamide 3000 mg/m2 iv every 3 weeks, 3 cycles vincristin 2 mg iv every 3 weeks, 3 cycles doxorubicin 75 mg/m2 iv every 3 weeks, 3 cycles Prednisolone 300 mg/m2 divided into five days po every 3 weeks, 3 cycles pegfilgrastim 6 mg sc every 3 weeks.
~3 cycles consisting of combination treatment of above mentioned drugs are given."
12004361|NCT00558220|Procedure|Induction treatment part 2 with PBPC collection|"Starts three weeks after last cycle of Induction part 1.
~Etoposide 240 mg/m2 divided into equal doses for four days, together with methylprednisolone 2000 mg divided into equal doses for four days, together with cisplatin 100 mg/m2 divided into equal doses for four days, and together with cytarabine 2000 mg/m2 iv one dose on 4th day of treatment. Filgrastim 10-12 ug/kg from day five after start of chemotherapy untill stem cell collection.
~Peripheral blood progenitor cell collection (PBPC) is started when CD34 positive cells are >20/cubic milimeter of blood and continued untill 5 million of CD34 positive cells are collected from peripheral blood."
12004362|NCT00558220|Procedure|Induction treatment part 3|"Part 3 of induction treatment is given approximately one week after the end of Part 2.
~Etoposide 240 mg/m2 divided into equal doses for four days, methylprednisolone 2000 mg divided into equal doses for four days, cisplatin 100 mg/m2 divided into equal doses for four days, cytarabine 2000 mg/m2 iv one dose on day 4 of chemotherapy and pegfilgrastim 6 mg on day five of chemotherapy are given twice three weeks apart."
12004363|NCT00558220|Procedure|Consolidation treatment part 1: HD-chemotherapy with ASCT|"Consolidation treatment Part 1 starts 4-8 weeks after the second cycle of Induction treatment Part 3.
~High dose chemotherapy (HD-chemotherapy) consists of:
~BCNU 300 mg/m2 is given on day 1, etoposide 800 mg/m2 divided into four equal doses is given on day 2-5, cytarabine 1600 mg/m2 divided into eight equal doses is given on day 2-5, melphalan 140 mg/m2 is given on day 6.
~On day 7, collected stem cells from peripheral blood (see Induction treatment part 1) are infused back to the patient. This is called autologous transplantation (ASCT). Filgrastim 5 ug/kg is given from day 14 (start of the chemotherapy being day 1) until neutrophil recovery."
12004364|NCT00558220|Radiation|Consolidation treatment part 2: Radiotherapy|Radiotherapy is started given 4-8 weeks after the autologous transplantation. It is given to patients with initially bulky disease (>10 cm at diagnosis) or to patients with residual disease after Induction treatment part 1-3 and Consolidation treatment part 1. 30-40 Gy are given in 2 Gy fractions over 3-4 weeks.
12004365|NCT00558207|Drug|ARQ 197|120 mg capsule administered twice daily for 240 mg total daily dose
12004366|NCT00558207|Drug|gemcitabine|1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 4 weeks for the first 28 days (cycle). Each subsequent cycle will consist of 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 3 weeks with no drug administered in the 4th week.
12004367|NCT00558194|Behavioral|Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training|12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
12004368|NCT00558194|Behavioral|Standard Behavioral Weight Loss Treatment|12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
12004369|NCT00558181|Drug|rituximab, methylprednisolone|Subjects will receive up-to 6 courses of IV infusion of Methylprednisolone and Rituximab every 21 day.
12004370|NCT00558155|Drug|peptisorb|standard isocaloric eteral diet (1 ml = 1 kcal)
12004371|NCT00558155|Drug|Stresson|Oligopeptic, enteral diet (1 ml=1.25 kcal)
12004372|NCT00558155|Drug|Parenteral nutrition|Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
12004373|NCT00558155|Drug|Omegaven, Dipeptiven|Immunostimulating components: Omegaven (omega-3-fatty acids) and Dipeptiven (Glutamine Arginine) Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
12004414|NCT00557843|Drug|Saline|Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
12004763|NCT00555282|Device|central venous catheter|coated central venous catheter
12004374|NCT00558142|Drug|Acetylcysteine|Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
12004375|NCT00558142|Drug|Visipaque 320|100mls IV dose as single dose
12004376|NCT00558142|Drug|Visipaque 320|The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
12004377|NCT00558129|Device|X-STOP®|Surgical implantation of X-STOP IPD device
12004378|NCT00558129|Procedure|Laminectomy|Standard laminectomy techniques will be used and may include laminotomy, foraminotomy and/or laminectomy as appropriate. In some cases at the discretion of the treating physician, fusion may indicated to stabilize the segment.
12004379|NCT00558116|Device|Dynamic splinting|The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.
12004380|NCT00558103|Drug|lapatinib|Oral administration
12004381|NCT00558103|Drug|Pazopanib|Oral administration
12004382|NCT00558090|Drug|morphine|patients receive 7,5 mg morphine iv 30 minutes before intervention (turning of the patient), the day after admission in the ICU. before, during and after, the patient will be asked to rate the pain using the NRS
12004383|NCT00558077|Drug|Metformin plus clomiphene citrate|Metformin administration will start from 3rd day of a P-induced withdrawal bleeding with a dose of 850 mg (1 tablet daily) and increasing the dosage after one week up to 1700 mg/day (two tablets daily). Clomiphene citrate CC will be administered for five days beginning on cycle day 3rd of a P-induced withdrawal bleeding using a starting dose of 50 mg daily. If ovulation will not occur, the dose will be increased by 50 mg in successive cycles until the ovulation will be achieved or up to a maximal dose of 150 mg daily.
12004384|NCT00558077|Procedure|Laparoscopic ovarian drilling|Laparoscopic ovarian drilling will be performed as follows: according to ovary size three to six punctures will be performed at each ovary inserting an insulated needle cautery of 36 mm perpendicularly as possible to the ovarian surface with a cutting current of 100 watt power. Then, the needle will be activated for 2-3 seconds at each point using a coagulating current of 40 watt power. At completion of the procedure, the ovarian surface will be washed with a crystalloid solution and all injured areas will be completely covered with hyaluronic acid gel.
12004385|NCT00558064|Drug|telmisartan+amlodipine|
12004386|NCT00558064|Drug|amlodipine|
12004387|NCT00558051|Biological|DC-based vaccine|Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 4 intradermal injections once a day for 4 days.
12004388|NCT00558051|Biological|DC-based vaccine|Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 1 intranodal injection.
12004389|NCT00558051|Biological|DC-based vaccine|Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of a 4-day intralymphatic infusion.
12004390|NCT00558038|Drug|AST-120|AST-120
12004391|NCT00558038|Drug|lactulose|lactulose
12004392|NCT00558025|Drug|Pramipexole Extended Release|
12004393|NCT00558025|Drug|Pramipexole Immediate Release|
12004394|NCT00558012|Drug|Intravenous zoledronic acid|Intravenous zoledronic acid 5.0 mg once
12004395|NCT00558012|Dietary Supplement|Vitamin D 800 IU/daily|Daily divided dose
12004396|NCT00558012|Dietary Supplement|Calcium 1200 mg/daily|supplement plus diet
12004397|NCT00557999|Other|Application of mechanical ventilation weaning protocol|Application protocol for 8 months in experimental group
12004398|NCT00557986|Procedure|Primary surgery|Primary breast surgery before systemic therapy
12004399|NCT00557973|Drug|XP19986 SR1, 10 mg BID|XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
12004400|NCT00557973|Drug|XP19986 SR1, 20 mg BID|XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
12004401|NCT00557973|Drug|XP19986 SR1, 30 mg BID|XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
12004402|NCT00557973|Drug|Placebo|Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.
12004403|NCT00557960|Drug|Mixed salts of a single-entity amphetamine|
12004404|NCT00557960|Drug|Atomoxetine hydrochloride|
12004405|NCT00557947|Device|Suture|intradermal and topical suturing
12004406|NCT00557947|Device|Dermabond Protape (Prineo)|cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
12004407|NCT00557934|Other|dobutamine|dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
12004408|NCT00557921|Drug|CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin|(CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
12004409|NCT00557921|Drug|Plavix (clopidogrel 75 mg) and aspirin|(CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
12004410|NCT00557908|Drug|VWF/FVIII products|"Participants in the prospective phase of the study undergo an escalation of treatment from receipt of one to three levels of VWD product. All subjects enrolled will begin treatment on the level one and remain on this regimen for the duration of follow-up, or until they meet the criteria for escalation to level two or three (if indeed they do meet the criteria.)
~Dosing for joint bleeding, epistaxis, and GI bleeding indications: 50 U RCo/kg once per week, 50 U RCo/kg twice per week, or 50 U RCo/kg three times per week.
~Dosing for menorrhagia: 50 U RCo/kg on day 1 of menses for 2 cycles, 50 U RCo/kg on days 1 and 2 of menses for 2 cycles, or 50 U RCo/kg on days 1, 2, and 3 of menses"
12004411|NCT00557882|Device|synthetic polypropylene mesh|Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
12004412|NCT00557856|Drug|PF-03446962|To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.
12004413|NCT00557843|Drug|Bupivacaine|Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
12004415|NCT00557830|Drug|Sorafenib Escalated Dose|Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
12004416|NCT00557830|Drug|Sorafenib Standard Dose|Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
12004417|NCT00557817|Drug|Darbepoetin alpha (Aranesp)|Darbepoetin alpha (Aranesp) will be administered subcutaneously (s.c.) at the dose of 300 µg. The first dose will be given on day 28 and the following doses at 2-week intervals around days 42, 56, 70, 84, 98 and 112 post-transplant. Once the target Hb (13 g/dL) has been attained, the dose of Aranesp will be reduced by half to 150 µg. If the Hb increases to > 14 g/dL, Aranesp will be withheld and resumed at the dose of 150 µg when the Hb decreases < 13 g/dL. If the Hb decreases to < 12 g/dL, the dose of Aranesp will be increased to 300 µg again.
12004418|NCT00557817|Drug|Iron saccharate (Venofer)|Iron saccharate (Venofer) will be administered intravenously (i.v.) at the dose of 200 mg (2 vials of Venofer) on days 28, 42 and 56 after the transplant. Venofer will be diluted in 250 ml saline and infused over 60 minutes. Iron will be omitted in patients with severe iron overload (serum ferritin > 2500 µg/L in the absence of inflammation or liver necrosis) or elevated transferrin saturation (TS > 60%) between days 21 and 56. No iron supplementation will be allowed in arm 1. No iron supplementation will be allowed in arm 2 before day 70 after the transplant. In arms 2 and 3, if patients have evidence of functional iron deficiency (transferrin saturation < 20%) on day 70 or later, they will receive 300 mg of Venofer over 90 min, for a minimum of 2 doses.
12004419|NCT00557804|Device|MUSE clinical system|non-invasive external monitoring device
12004420|NCT00557791|Drug|Bevasiranib|Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
12004421|NCT00557791|Drug|ranibizumab|Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
12004422|NCT00557752|Device|Non-invasive ventilation|Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.
12004423|NCT00557739|Drug|mometasone furoate|Topical 0.1% mometasone furoate
12004424|NCT00557739|Drug|nortriptyline HCl|Topical 0.05% or 0.1% nortriptyline HCl
12004425|NCT00557739|Drug|Vehicle (placebo)|Topical placebo
12004426|NCT00557713|Drug|bevacizumab|"-Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14)
~-Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days))
~-Surgery (6-8 weeks after last bevacizumab dose)
~-Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)"
12004427|NCT00557700|Drug|Administration of inhaled tiotropium bromide|Administration of inhaled tiotropium bromide
12004428|NCT00557700|Drug|Administration of placebo|Administration of placebo
12004429|NCT00557661|Drug|CD-NP|24 hr intravenous infusion
12004430|NCT00557648|Behavioral|Group CBT for children|CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.
12004431|NCT00557648|Behavioral|Group CBT for children plus parent training|CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.
12004432|NCT00557635|Procedure|Chirurgical procedure|Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.
12004433|NCT00557622|Drug|paroxetine|BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD)
12004434|NCT00557622|Other|placebo|placebo
12004435|NCT00557609|Drug|ARQ 197|360 mg administered twice daily until disease progression or other discontinuation criterion is met
12004436|NCT00557596|Drug|AEG35156|AEG35156 will be given as a 2-hour intravenous infusion once weekly, only on weeks when gemcitabine is administered, with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1
12004437|NCT00557583|Drug|VBY 376|Doses of 50mg and higher or placebo will be evaluated.
12004438|NCT00557557|Drug|Drug: 5-FU|Dose escalation (200 to 900 mg/m²) scheme, one hour isolated hepatic perfusion prior to standard treatment.
12004439|NCT00557557|Drug|Drug: Oxaliplatin|40 mg/m², one hour isolated hepatic perfusion prior to standard treatment.
12004440|NCT00557544|Drug|metoclopramide|metoclopramide 0,15 mg/kg
12004441|NCT00557544|Drug|placebo|placebo per os
12004442|NCT00557544|Drug|ketoprofen|ketoprofen 1 mg/Kg
12004443|NCT00557531|Device|BL-1040|2 mL of BL-1040
12004444|NCT00557518|Drug|Alagebrium|200 mg bid
12004445|NCT00557518|Drug|Placebo|bid
12004446|NCT00557505|Drug|PF-03732010|IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.
12004447|NCT00557492|Drug|Avastin (bevacizumab)|10 mg/kg, days 1, 15, 29 and 43
12004448|NCT00557492|Drug|Gemzar (Gemcitabine)|On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).
12004449|NCT00557492|Radiation|external beam radiotherapy|3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy
12004450|NCT00557466|Drug|indacaterol|Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
12004451|NCT00557466|Drug|formoterol|Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
12004452|NCT00557466|Drug|placebo to indacaterol|Placebo TWISTHALER® device
12004453|NCT00557466|Drug|placebo to formoterol|Placebo AEROLIZER® device
12004454|NCT00557466|Drug|short acting β2- agonist|100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
12004455|NCT00557453|Drug|Antibiotic treatment|Cefuroxime 750mg X3/d, Ampicillin 2G X4/d, Flagyl 500mg X3/d, Augmentin 1G X3/d, Gentamycin 240mg X1/d, Clindamycin 600mg X3/d, Ciprofloxacin 400mg X2/d All drugs will be administered IV until clinical improvement.
12004456|NCT00557453|Drug|No antibiotics|Allowed medications for both groups will include PPI / H2 blockers, home medication, SC insulin for diabetes, and SC clexane if indicated.
12004457|NCT00557440|Drug|fluticasone propionate/salmeterol|Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI.
12004458|NCT00557440|Drug|indacaterol maleate / mometasone furoate|Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device.
12004459|NCT00557440|Drug|placebo to indacaterol/mometasone|Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device.
12004460|NCT00557440|Drug|placebo to fluticasone propionate/salmeterol|Placebo to fluticasone propionate / salmeterol delivered via MDDPI.
12004461|NCT00557427|Drug|hypericum|250mg tablets twice daily for 8 weeks
12004462|NCT00557427|Drug|fluoxetine|20mg - 40mg daily for 8 weeks
12004463|NCT00557401|Drug|XP19986 SR3, 20 mg QD|XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
12004464|NCT00557401|Drug|XP19986 SR3, 40 mg QD|XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
12004465|NCT00557401|Drug|XP19986 SR3, 60 mg QD|XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
12004466|NCT00557401|Drug|XP19986 SR3, 30 mg BID|XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.
12004467|NCT00557401|Drug|Placebo|Placebo tablet taken orally for approximately 32 days with titration and taper periods.
12004468|NCT00557388|Dietary Supplement|Protein/Amino Acids|Casein Whey Leucine
12004469|NCT00557388|Other|Physical exercise|The physical exercise protocol will consist of low intensity cycling and light resistance-type exercise; after 5 minutes of self-paced cycling, subjects will perform 6 sets of 10 repetitions on the horizontal leg press machine (Technogym BV, Rotterdam, The Netherlands) and 6 sets of 10 repetitions on the leg extension machine (Technogym BV, Rotterdam, The Netherlands). The first 2 sets of both resistance exercises will be performed at 40% of the subjects' 1RM. Sets 3-4, and 5-6 will be performed at 55% and 75% of 1RM, respectively, with 2 minutes rest intervals between sets.
12004470|NCT00557362|Drug|Natamycin 5%|One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake
12004471|NCT00557362|Drug|Voriconazole|"Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution.
~One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake"
12004472|NCT00557362|Procedure|Corneal de-epithelialization|Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.
12004473|NCT00557349|Drug|Omeprazole|40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
12004474|NCT00557349|Drug|Famotidine|40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
12004475|NCT00557336|Drug|somatropin|
12004476|NCT00557323|Drug|Lanthanum carbonate|
12004477|NCT00557310|Drug|teriparatide|20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
12004478|NCT00557284|Drug|Montelukast|4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
12004479|NCT00557284|Drug|Placebo|Oral granules or chewable tablet, PO QD (given oral daily)
12004480|NCT00557245|Drug|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
12004481|NCT00557245|Drug|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
12004482|NCT00557245|Drug|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
12004483|NCT00557232|Drug|bevacizumab|1.25mg/month
12004484|NCT00557219|Drug|fenoldopam (Corlopam)|continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
12004485|NCT00557219|Drug|placebo|continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
12004486|NCT00557219|Drug|ketanserin (Sufrexal)|continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
12004487|NCT00557206|Drug|Oxaliplatin and Docetaxel|"Chemotherapy
~Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days."
12004488|NCT00557193|Drug|Asparaginase|Given IV, IM, or PO
12004489|NCT00557193|Drug|Cyclophosphamide|Given IV
12004490|NCT00557193|Drug|Cytarabine|Given IV or IT
12004491|NCT00557193|Drug|Daunorubicin Hydrochloride|Given IV
12004492|NCT00557193|Drug|Dexamethasone|Given IV or PO
12004493|NCT00557193|Drug|Etoposide|Given IV
12004494|NCT00557193|Biological|Filgrastim|Given IV or SC
12004495|NCT00557193|Other|Laboratory Biomarker Analysis|Correlative studies
12004496|NCT00557193|Drug|Lestaurtinib|Given PO
12004497|NCT00557193|Drug|Leucovorin Calcium|Given IV
12004498|NCT00557193|Drug|Mercaptopurine|Given PO
12004499|NCT00557193|Drug|Methotrexate|Given IV, IT, or PO
12004500|NCT00557193|Drug|Methylprednisolone|Given IV
12004501|NCT00557193|Drug|Pegaspargase|Given IM
12004502|NCT00557193|Other|Pharmacological Study|Correlative studies
12004503|NCT00557193|Drug|Prednisone|Given PO
12004504|NCT00557193|Drug|Therapeutic Hydrocortisone|Given IT
12004505|NCT00557193|Drug|Vincristine Sulfate|Given IV
12004506|NCT00557180|Drug|Beclomethasone dipropionate HFA|Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
12004681|NCT00555919|Drug|Lonaprisan (ZK 230211, BAY86-5044)|25 mg daily oral treatment
12004507|NCT00557180|Drug|Tiotropium bromide|Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
12004508|NCT00557180|Drug|Salmeterol xinafoate|Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
12004509|NCT00557154|Device|ultrasound|ultrasound used to identify target vein
12004510|NCT00557154|Device|standard technique for venipuncture|routine equipment
12004511|NCT00557128|Drug|COREG CR and lisinopril (FDC)|
12004512|NCT00557115|Other|Early pulmonary rehabilitation (EPR)|Multidisciplinary exercise programme in the format of standard pulmonary rehabilitation. Consists of 2 supervised exercise and educations sessions per week for up to 16 sessions within 3-months. Participants are encouraged to keep an exercise diary at perform at least one exercise session at home unsupervised.
12004513|NCT00557102|Biological|cetuximab|
12004514|NCT00557102|Biological|filgrastim|
12004515|NCT00557102|Drug|fluorouracil|
12004516|NCT00557102|Drug|irinotecan hydrochloride|
12004517|NCT00557102|Drug|leucovorin calcium|
12004518|NCT00557089|Drug|rhDNAse|2.5 mg rhDNase will be dispensed in 2.5 ml vials and administered once a day for 28 days. Treatment will be administered by inhalation.
12004519|NCT00557089|Other|Placebo|2.5 mg of the placebo will be dispensed in 2.5 ml vials and administered once a day over 28 days. Treatment will be administered by inhalation.
12004520|NCT00557076|Behavioral|Familiar Auditory Sensory Training|Patient is provided with customized recordings of stories told by people well known to the patient at least 1 year prior to injury. The stories represent specific events experienced by both the patient and the storyteller. Patients received FAST for 10 minutes 4 times per day, with at least 2 hours in between, for 6 week.
12004521|NCT00557076|Behavioral|Sham Auditory Sensory Training|The sham intervention is zero minutes of Familiar Auditory Sensory Training. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence.
12004522|NCT00557050|Other|Training|10-week eccentric hamstring muscle training
12004523|NCT00557037|Drug|Phenoxodiol|Oral capsule, 400 mg every 8 hours daily, for 12 weeks - assement to a maximum of 12 months
12004524|NCT00557024|Procedure|RFA|radiofrequency ablation
12004525|NCT00557024|Procedure|radiotherapy after RFA|radiotherapy after RFA
12004526|NCT00557011|Drug|NRP104|30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
12004527|NCT00557011|Drug|Adderall XR|10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
12004528|NCT00557011|Drug|Placebo|Placebo capsule taken once daily in the morning
12004529|NCT00556998|Drug|Voriconazole|Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.
12004530|NCT00556972|Device|Fecal Incontinence Management System|The device is intended to remedy fecal incontinence.
12004531|NCT00556959|Drug|high dose clonidine HCl sustained release|high dose clonidine HCl sustained release tablets for 8 weeks
12004532|NCT00556959|Drug|low dose clonidine HCl sustained release|low dose clonidine HCl sustained release tablets for 8 weeks
12004533|NCT00556959|Drug|placebo|placebo tablets for 8 weeks
12004534|NCT00556946|Drug|Combined Photodynamic & Pulsed Dye Laser Treatment|Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser
12004535|NCT00556933|Drug|rabbit anti-thymocyte globulin|A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
12004536|NCT00556933|Drug|mycophenolate mofetil|Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
12004537|NCT00556933|Drug|rabbit anti-thymocyte globulin|6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
12004538|NCT00556933|Drug|sirolimus|Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
12004539|NCT00556933|Drug|tacrolimus|Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
12004540|NCT00556920|Drug|COREG CR|
12004541|NCT00556907|Radiation|Intraoperative radiotherapy|20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
12004542|NCT00556907|Device|Intraoperative radiotherapy|20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
12004543|NCT00556894|Drug|CF101|orally q12h
12004544|NCT00556894|Drug|Placebo|orally q12h
12004545|NCT00556868|Other|Breakfast/no breakfast|"A: Breakfast on the first day of intervention. Fasting (no breakfast) on the second day of intervention.
~B: Breakfast on the second day of intervention. Fasting (no breakfast) on the first day of intervention"
12004546|NCT00556855|Other|E-DO|topical lotion, once daily (evening), total duration: 4 weeks
12004547|NCT00556855|Other|Placebo|topical lotion, once daily (evening), total duration: 4 weeks
12004548|NCT00556842|Device|Total hip arthroplasty|Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.
12004682|NCT00555919|Drug|Lonaprisan (ZK 230211, BAY86-5044)|100 mg daily oral treatment
12004549|NCT00556842|Device|Hemi-arthroplasty|Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.
12004550|NCT00556816|Behavioral|on demand clinic|Outpatient on demand clinic
12004551|NCT00556816|Behavioral|Control|conventional outpatient clinic
12004552|NCT00556803|Procedure|radiofrequency ablation|radiofrequency ablation
12004553|NCT00556803|Procedure|TACE after RFA|TACE after RFA within one month
12004554|NCT00556790|Procedure|Standard Care|standard fluid regime, delayed feeding
12004555|NCT00556790|Procedure|Fast Track care|restrictive fluid regime, early oral feeding, enforced mobilisation
12004556|NCT00556777|Procedure|axillary lymph node dissection|
12004557|NCT00556777|Procedure|conventional surgery|
12004558|NCT00556777|Procedure|sentinel lymph node biopsy|
12004559|NCT00556777|Radiation|intraoperative radiation therapy|
12004560|NCT00556764|Drug|[123I] IBVM and SPECT imaging|Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.
12004561|NCT00556764|Drug|Subjects will undergo the 123-I IBVM imaging visit|Subjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging.
12004562|NCT00556738|Procedure|Nasal Continuous Positive Airway Pressure ventilation|Nasal Continuous Positive Airway Pressure ventilation
12004563|NCT00556738|Procedure|Intrapulmonary Percussive Ventilation|Intrapulmonary Percussive Ventilation
12004564|NCT00556712|Drug|erlotinib [Tarceva]|150mg po daily
12004565|NCT00556712|Drug|Placebo|po daily
12004566|NCT00556699|Drug|rituximab|Escalating intravenous repeating dose
12004567|NCT00556699|Drug|SGN-40|Escalating intravenous repeating dose
12004568|NCT00556673|Drug|indacaterol maleate/mometasone furoate|Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.
12004569|NCT00556673|Drug|placebo to indacaterol maleate/mometasone furoate|Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
12004570|NCT00556673|Drug|fluticasone proprionate / salmeterol xinafoate|Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.
12004571|NCT00556660|Drug|[123I] AV-151|To assess the dynamic uptake and washout of 123-I AV151, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and Alzheimer's (AD) subjects
12004572|NCT00556647|Procedure|fast track diagnosis|fast-track diagnosis, PET-CT, bronchoscopy
12004573|NCT00556647|Procedure|conventional diagnosis|out-patient diagnosis
12004574|NCT00556634|Drug|Efavirenz|"Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward)
~OR
~Efavirenz usual dosage (600 mg/day from the first day)"
12004575|NCT00556621|Drug|cisplatin|
12004576|NCT00556621|Drug|gemcitabine hydrochloride|
12004577|NCT00556621|Procedure|biopsy|
12004578|NCT00556621|Procedure|cystoscopy|
12004579|NCT00556621|Procedure|therapeutic conventional surgery|
12004580|NCT00556621|Radiation|radiation therapy|
12004581|NCT00556608|Device|Sinovial® (syringe containing sodium hyaluronate solution)|2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.
12004582|NCT00556608|Device|Synvisc® ( syringe containing Hylan G-F 20 solution)|2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.
12004583|NCT00556595|Procedure|primary electrophysiological approach|primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
12004584|NCT00556595|Procedure|primary anatomical approach|primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps
12004585|NCT00556569|Other|CHAM JAM|"CHAM JAM (previously known as Moving Smart (MS) program) is a daily, 10-minute classroom-based physical activity program led by teachers that integrates academic objectives with physical activity"
12004586|NCT00556543|Device|U-plate fracture repair system|All subjects meeting inclusion criteria will undergo surgery for the repair of their fractured rib/s using the U-plate device. Subjects will be monitored daily during the entire course of their hospitalization for adverse experiences. Subjects will be contacted by phone to complete the MPQ and SF-36 Health Survey. Subjects will be asked if and when they have returned to work or to their previous level of functioning. Subjects will be asked if they had any complications or problems associated with their surgery.
12004587|NCT00556504|Drug|TCM-700C|An add-on drug to conventional treatment of Hepatitis C
12004588|NCT00556504|Drug|Peginterferon alfa-2a|conventional treatment of Hepatitis C
12004589|NCT00556504|Drug|Ribavirin|conventional treatment of Hepatitis C
12004590|NCT00556504|Drug|Placebo|Placebo, without acting ingredient.
12004591|NCT00556491|Drug|minocycline|given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
12004592|NCT00556491|Drug|placebo|placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
12004593|NCT00556478|Drug|PSD502, contains a mixture of lidocaine and prilocaine|"PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
12004683|NCT00555906|Drug|Bortezomib|Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone.
12004684|NCT00555906|Drug|Dexamethasone|20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib.
12004594|NCT00556478|Drug|Placebo|"The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
12004595|NCT00556465|Drug|N-acetylcysteine|600 mg of effervescent N-acetylcysteine tablet twice per day for three months
12004596|NCT00556452|Drug|Clofarabine/Busulfan x 4|"Clofarabine IV (dose levels)
~1st dose level: 20 mg/m2/day x 5 days
~2nd dose level: 30 mg/m2/day x 5 days
~3rd dose level: 40 mg/m2/day x 5 days
~Busulfan IV 3.2 mg/kg daily x 4 days"
12004597|NCT00556452|Procedure|Peripheral blood stem cell transplant|Peripheral blood stem cell transplant, after pre-conditioning drug treatment
12004598|NCT00556452|Radiation|Total Lymphoid Irradiation|Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant
12004599|NCT00556439|Drug|Abatacept|"Participants will receive a fixed dose of abatacept, approximating 10mg per kilogram of body weight. The following dosing rules will be followed:
~Participants weighing less than 60kg will receive 500mg of abatacept.
~Participants weighing 60 to 100kg will receive 750mg of abatacept.
~Participants weighing more than 100kg will receive 1000mg of abatacept.
~Abatacept will be administered in a 30-minute intravenous infusion on Days 1, 15, 29 (Month 1) and at Month 2. In the absence of toxicity or relapse, participants will remain on abatacept at the same dosage until randomization at Month 3. After randomization, only Group A (giant cell arteritis) and Group C (Takayasu arteritis) participants will continue on abatacept."
12004600|NCT00556439|Drug|Placebo|Placebo abatacept infusions will be given monthly after random assignment at Month 3.
12004601|NCT00556426|Device|Bard Recovery G2 Filter System|Retrieval of previously placed RECOVERY G2 IVC filter
12004602|NCT00556413|Biological|cetuximab|
12004603|NCT00556413|Drug|fluorouracil|
12004604|NCT00556413|Drug|irinotecan hydrochloride|
12004605|NCT00556413|Drug|leucovorin calcium|
12004606|NCT00556413|Drug|oxaliplatin|
12004607|NCT00556400|Drug|Lo-Ovral Oral Contraceptive Pills|
12004608|NCT00556400|Drug|Placebo - sugar pill|
12004609|NCT00556387|Drug|saline|1 mg/kg IV bolus slowly over 1-2 minutes followed by 0.5 mg/kg IV continuous infusion over 48 hours or until discontinuation of ICP monitor (whichever occurs first)
12004610|NCT00556387|Drug|Ketamine|1 mg/kg IV bolus slowly over 1-2 minutes, followed by 0.5 mg/kg IV continuous infusion for 48 hours or until discontinuation of ICP monitor (whichever occurs first)
12004611|NCT00556374|Drug|Placebo|
12004612|NCT00556374|Biological|Denosumab|Administered as a subcutaneous injection
12004613|NCT00556374|Drug|Non-steroidal aromatase inhibitor therapy|An approved non-steroidal aromatase inhibitor therapy (eg, anastrazole) in the adjuvant setting
12004614|NCT00556374|Drug|Zoledronic Acid|5 mg zoledronic acid administered at a constant infusion rate
12004615|NCT00556374|Other|Standard of Care|Standard of care (SoC) as recommended by the treating physician, depending on individual factors such as bone density, lifestyle recommendations by the Investigator such as diet, physical activities and sun exposure, as well as local treatment standards.
12004616|NCT00556361|Drug|saline|2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
12004617|NCT00556361|Drug|ketamine|2 mg/Kg IV within 5 minutes of cardiopulmonary bypass
12004618|NCT00556348|Drug|bevacizumab|1.25mg
12004619|NCT00556335|Procedure|manual aspiration|air aspiration
12004620|NCT00556335|Procedure|conventional drainage|drainage, pneumocath
12004621|NCT00556322|Drug|Alimta or Taxotere|500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)
12004622|NCT00556322|Drug|erlotinib [Tarceva]|150mg po daily
12004623|NCT00556309|Device|Optical Coherence Tomography|Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.
12004624|NCT00556296|Drug|NRP104|NRP104 30mg capsule once daily in a.m.
12004625|NCT00556296|Drug|NRP104|NRP104 50mg capsule once daily in a.m.
12004626|NCT00556296|Drug|NRp104|NRP104 70mg capsule once daily in a.m.
12004627|NCT00556296|Drug|Placebo|Placebo
12004628|NCT00556283|Device|STARR|Stapled Trans-Anal Rectal Resection for the treatment of ODS
12004629|NCT00556283|Behavioral|Biofeedback|electromyographic-based treatment sessions
12004630|NCT00556270|Drug|Matrifen|as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.2)
12004631|NCT00556257|Drug|Cyclosporine|Standard of care
12004632|NCT00556257|Drug|CP-690-,550|CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12
12004633|NCT00556244|Procedure|ILM peeling|ILM maculorhexis is initiated using scraper and completed using a 25-gauge Synergetics (St. Louis, MO) forceps.
12004634|NCT00556218|Behavioral|Tibetan Meditation Program|12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes.
12004635|NCT00556218|Behavioral|No Meditation|No meditation; usual care.
12004636|NCT00556205|Drug|Sunitinib|Sunitinib orally once daily
12004637|NCT00556205|Drug|Bevacizumab|Intravenously every 14 days
12004638|NCT00556192|Drug|rituximab|"Rituximab of 1000 mg given 2 weeks apart. On day the of rituximab, and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5.
~A treatment dose rituximab of 1000mg given 2 weeks apart and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5, and 'pulse' cyclophosphamide 500mg/m2 at baseline and day 14.
~Sequential therapy with oral cyclophosphamide (50 to 100 mg/day) for 6 months followed by azathioprine (up to 2.5mg/kg/day) for maintenance up to 12 months. Oral prednisolone will be given at 0.5 mg/kg/day (up to 30 mg daily) for 4 weeks, tapered by 5 mg every 2 weeks thereafter until 5mg /day for the rest of the study period."
12004639|NCT00556179|Drug|Lactoserum (Dermacyd Femina®)|Once a day during three months
12004685|NCT00555906|Drug|PD 0332991|Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.
12004640|NCT00556166|Device|Enterra Therapy Gastric Stimulator|"The intramuscular stomach leads, implanted in a minimally invasive surgical procedure lasting 1-3 hours, are placed on the greater curvature of the stomach. The implanted pulse generator (IPG) is about 2 1/2 x 2 x 1/2 and is implanted in a subcutaneous pocket, generally created in the abdominal area, and is then connected to the leads. The IPG provides the energy source that delivers the electrical pulse to the stomach muscle through the stomach leads to improve the symptoms of gastroparesis.
~The doctor will use an external programmer to change the settings of the neurostimulator and control the neurostimulator after implantation. Part of the programmer is held outside the body over the implant site and can adjust or change the settings of the neurostimulator using radio remote control."
12004641|NCT00556153|Drug|[F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical|A single dosage of the diagnostic drug will be administered to individuals who meet inclusion criteria after informed consent.
12004642|NCT00556140|Drug|Aripiprazole|"Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study.
~Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia.
~You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day."
12004643|NCT00556127|Drug|Rituximab|375 mg/m2 on day 1
12004644|NCT00556127|Drug|Epirubicin|110 mg/m2 on day 3
12004645|NCT00556127|Drug|Cyclophosphamide|1200 mg/m2 on day 3
12004646|NCT00556127|Drug|Vincristine|1.4 mg/m2 (maximum 2 mg) on day 3
12004647|NCT00556127|Drug|Prednisone|40 mg/m2 from day 1 to 5
12004648|NCT00556127|Drug|Granulocyte-colony-stimulating factor|(G-CSF 5 μg/Kg/day) from day 5 to day 11
12004649|NCT00556127|Drug|Mitoxantrone|8 mg/m2 for 3-day
12004650|NCT00556127|Drug|Cytarabine ARA-C|2 g/m2/12 hours for six doses in 3-hour infusion
12004651|NCT00556127|Drug|Dexamethasone|4 mg/m2/12 hours before ARA-C administration
12004652|NCT00556127|Drug|Carmustine BCNU|300 mg/m2 on day -7
12004653|NCT00556127|Drug|Etoposide|100 mg/m2/12 hours
12004654|NCT00556127|Drug|Melphalan|140 mg/m2 on day -2
12004655|NCT00556127|Radiation|Radiotherapy|Involved Field Radiotherapy (IF-RT)
12004656|NCT00556127|Procedure|PBSC reinfusion|ASCT
12004657|NCT00556114|Device|Optical Coherence Tomography|Optical Coherence Tomography
12004658|NCT00556101|Procedure|Whole body magnetic resonance angiography|
12004659|NCT00556088|Drug|LBH589, Paclitaxel, Carboplatin, Bevacizumab|"LBH589 will be administered orally twice weekly. Paclitaxel and carboplatin will be administered intravenously every 21 days.
~Once the MTD is established, drug dosages will be adjusted downward by one dose level and bevacizumab 15mg/kg intravenously every 3 weeks will be administered to a subset of patients with non-small cell lung cancer."
12004660|NCT00556075|Drug|Proellex 25 mg|1 capsule daily for 4 months
12004661|NCT00556075|Drug|Placebo|1 capsule daily for 4 months
12004662|NCT00556075|Drug|Proellex 50 mg|2 capsules daily for 4 months
12004663|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
12004664|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
12004665|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
12004666|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
12004667|NCT00556049|Drug|Gemcitabine|Intravenously on days 1 and 8 of each 21-day treatment cycle.
12004668|NCT00556049|Drug|Sunitinib|Orally on days 1-14 of each 21-day treatment cycle
12004669|NCT00556023|Drug|CP-675,206 and gemcitabine|Escalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.
12004670|NCT00555997|Drug|Ziprasidone|20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
12004671|NCT00555997|Drug|Ziprasidone|20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
12004672|NCT00555997|Drug|Placebo|"0mg Placebo per day. Dose increases and dose decreases may occur, but patient will remain at 0mg placebo"
12004673|NCT00555984|Drug|Propofol + Remifentanil|Administered intravenously during surgery for maintenance of General Anesthesia
12004674|NCT00555984|Drug|Sevoflurane + Remifentanil|the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
12004675|NCT00555971|Drug|Omalizumab|Subjects randomized to Omalizumab prior to aspirin desensitization
12004676|NCT00555971|Drug|placebo|Subjects randomized to Placebo prior to aspirin desensitization
12004677|NCT00555958|Device|Active, implantable, intra-abdominal vagal blocking medical device|Intermittent, programmable, intra-abdominal vagal blocking
12004678|NCT00555945|Procedure|Gamma3 intramedullary nail (Stryker)|The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.
12004679|NCT00555945|Procedure|Sliding Hip Screw|The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
12004680|NCT00555932|Procedure|Ultrasound|All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.
12004686|NCT00555893|Drug|Oseltamivir|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
12004687|NCT00555893|Drug|Placebo|Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
12004688|NCT00555880|Drug|Midodrine hydrochloride|one dose, 10-30mg, given orally
12004689|NCT00555880|Drug|Placebo|Placebo
12004690|NCT00555867|Drug|Anastrozole|oral
12004691|NCT00555854|Behavioral|An individual motivational intervention program to promote and maintain self-care behaviour|5 individual interviews in an one year period
12004692|NCT00555841|Drug|ALC and Placebo|ALC and Placebo
12004693|NCT00555828|Genetic|Allogeneic Mesenchymal Precursor Cells (MPCs)|25 M allogeneic MPCs by transendocardial injection
12004694|NCT00555828|Procedure|Standard-of-care treatment with NOGA® mapping and staged injections.|Standard-of-care treatment with NOGA® mapping and staged injections.
12004695|NCT00555828|Genetic|Allogeneic Mesenchymal Precursor Cells (MPCs)|75 M allogeneic MPCs by transendocardial injection
12004696|NCT00555828|Procedure|Standard-of-care treatment with NOGA® mapping and staged injections.|Standard-of-care treatment with NOGA® mapping and staged injections.
12004697|NCT00555828|Genetic|Allogeneic Mesenchymal Precursor Cells (MPCs)|150 M allogeneic MPCs by transendocardial injection
12004698|NCT00555828|Procedure|Standard-of-care treatment with NOGA® mapping and staged injections.|Standard-of-care treatment with NOGA® mapping and staged injections.
12004699|NCT00555802|Other|exercise|exercise
12004700|NCT00555789|Drug|AEB071|200mg oral b.i.d.
12004701|NCT00555789|Drug|mycophenolic plus tacrolimus|720mg b.i.d. 2yrs
12004702|NCT00555776|Drug|Gabapentin|Gabapentin, 600 mg bid for the first two weeks, increased to a maximum dose of 1800 mg per day during the next 6 weeks if necessary.
12004703|NCT00555776|Drug|placebo|placebo is given with the same definition as Gabapentin
12004704|NCT00555763|Device|Tonometry|Tonometry : measurement of intraocular pressure with an applanation tonometer
12004705|NCT00555750|Drug|eszopiclone|3mg tablet, by mouth nightly 30 min before bed, for two months
12004706|NCT00555750|Drug|placebo|inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months
12004707|NCT00555737|Device|Capsule Endoscopy|Given® Diagnostic system with Pillcam SB
12004708|NCT00555724|Drug|BIIB022|IV infusion once every three weeks until disease progression or unacceptable toxicity
12004709|NCT00555711|Device|Modulated Imaging|Modulated Imaging
12004710|NCT00555698|Device|Deep Brain Stimulations for Depression|Deep Brain Stimulations for Depression
12004711|NCT00555685|Drug|NaCl 7,5% (Hypertonic Saline Solution)|Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
12004712|NCT00555685|Drug|NaCl 0,9%|Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days
12004713|NCT00555672|Drug|5-fluorouracil|5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
12004714|NCT00555672|Drug|cisplatin|Cisplatin is given 80 mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
12004715|NCT00555672|Drug|sunitinib malate|sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
12004716|NCT00555646|Drug|PH-10 (rose bengal disodium 0.001%)|"PH-10 with 544 nm LED light illumination
~OR
~PH-10 with ambient light exposure"
12004717|NCT00555646|Drug|Control|No treatment control.
12004718|NCT00555620|Drug|capecitabine|Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
12004719|NCT00555620|Drug|oxaliplatin|Oxaliplatin is given 110mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
12004720|NCT00555620|Drug|sunitinib malate|sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
12004721|NCT00555620|Drug|capecitabine|Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
12004722|NCT00555620|Drug|cisplatin|Cisplatin is given 80mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
12004723|NCT00555620|Drug|sunitinib malate|sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
12004724|NCT00555607|Drug|prednisolone|Prednisolone oral tablets (10 mg active ingredient per tablet) once a day at a dose of 0.5mg/kg bodyweight, during 14 days.
12004725|NCT00555594|Drug|Bevacizumab (Avastin)|One dose of 0.1cc of subconjunctival Bevacizumab was applied
12004726|NCT00555581|Drug|Imatinib Mesylate|In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months.
12004727|NCT00555568|Behavioral|recovery oriented mental health peer support group|This is a recovery-focused mental health education and support group led by peer facilitators
12004728|NCT00555568|Behavioral|recovery-oriented mental health clinician-led group|This is a recovery-focused mental health education and support group led by a mental health clinician
12004760|NCT00555321|Drug|Belatacept Less Intensive (LI)|"Intravenous (IV),
~10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12.
~After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE)"
12004761|NCT00555321|Drug|Mycophenolate Mofetil (MMF)|Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
12004729|NCT00555555|Biological|Alphanate SD/HT|A general guideline based on the product Full Prescribing Information is recommended with a maximum dose of 80 VWF:RCof IU/kg. The number of administrations before, during, and after the surgery procedure depends on the subject's clinical condition and the type of surgery itself. Single administrations or multiple doses may be appropriate. The dose of Alphanate® administered to each subject will be recorded as IU of VWF:RCof and also as IU of FVIII:C. The lot number for each vial of concentrate administered will also be recorded.
12004730|NCT00555542|Drug|rituximab|Patients are taking stable dose of methotrexate and at least 10mg folic acid per week for at least 4 weeks. Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. Premedication as standard prescription consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab. Oral prednisolone 60mg is tob e given from day 1-6 after rituximab infusion and 30mg from day 7-13.
12004731|NCT00555529|Procedure|radial artery applanation tonometry (RAAP)|non-invasive tonometry
12004732|NCT00555516|Other|EW02|"Name: EW02
~Dosage form: capsule.
~Dose(s): 350mg per capsule, 2 capsule tid.
~Dosing schedule: 2 capsule tid; 15 days (D3 to D17) of EW02 or placebo in Cycles 2 and 3."
12004733|NCT00555490|Dietary Supplement|Soy protein|35 % of protein from soy protein for 4-years
12004734|NCT00555477|Drug|anastrozole|1 mg tablet by mouth once a day
12004735|NCT00555464|Drug|Vincristine|Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI.
12004736|NCT00555464|Drug|Prednisone|Prednisolone given at 3 mg/kg/day by mouth for 12 week
12004737|NCT00555451|Drug|HE3286|"Dose escalating cohort driven study. 6 planned cohorts.
~HE3286 5 mg or placebo QD for 28 days;
~HE3286 10 mg (5 mg BID) or placebo BID for 28 days
~HE3286 20 mg (10 mg BID) or placebo BID for 28 days
~HE3286 40 mg (20 mg BID) or placebo BID for 28 days
~HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days
~HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM)"
12004738|NCT00555438|Drug|fondaparinux 1.5 mg/day|Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery
12004739|NCT00555425|Behavioral|Behavioral: Buprenorphine/naloxone maintenance (Mtn)|Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
12004740|NCT00555425|Behavioral|Behavioral: Buprenorphine/naloxone detoxification (Dtx)|Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.
12004741|NCT00555412|Drug|A - 10 mg loxapine q 4 h x 3 (30 mg total)|loxapine aerosol inhalation high dose regimen (30 mg total)
12004742|NCT00555412|Drug|B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)|loxapine aerosol inhalation middle dose regimen (20 mg total)
12004743|NCT00555412|Drug|C - 5 mg loxapine q 4 h x 3 (15 mg total)|loxapine aerosol inhalation low dose regimen (15 mg total)
12004744|NCT00555412|Drug|D - inhaled placebo q 4 h x 3|placebo aerosol inhalation (0 mg total)
12004745|NCT00555399|Drug|Vorinostat|"Phase I/Arm 1: Level 0 = 300 mg PO x 14 days; Level I = 400 mg PO x 14 days; Level II = 500 mg PO x 14 days.
~Phase I/Arm 3: Level -II = 300 mg PO x 14 days; Level -I = 400 mg PO x 14 days; Level 0 = 400 mg PO x 14 days; Level I = 500 mg PO x 14 days."
12004746|NCT00555399|Drug|Isotretinoin|"Phase I/Arm 1: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days.
~Phase I/Arm 2: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days.
~Phase I/Arm 3: Level -II = 100 mg/m^2/day PO x 21 days; Level -I = 100 mg/m^2/day PO x 21 days; Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days."
12004747|NCT00555399|Procedure|Surgical Resection|Surgical Resection for recurrent Glioblastoma Multiforme
12004748|NCT00555399|Drug|Temozolomide|"Phase I/Arm 2: All Levels = 150 mg/m2/day PO X 14 days.
~Phase I/Arm 3: Level 0 = 150 mg/m2/day PO X 14 days; Level I = 150 mg/m2/day PO X 14 days; Level -I = 125 mg/m2/day PO X 14 days; Level -II = 125 mg/m2/day PO X 14 days; Level -III = 100 mg/m2/day PO X 14 days."
12004749|NCT00555386|Dietary Supplement|Soy and Selenium|6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
12004750|NCT00555373|Drug|Sirolimus|"Tacrolimus (Prograf®) At 6 months post-transplantation, patients will have Prograf® tapered by 25% per week such that they will be off of this medication by 7 months post-transplantation.
~Sirolimus (Rapamune®):
~At 6 months post-transplantation, all patients will be administered Sirolimus at a dose of 1.65-2.79 mg/m2/day as a tablet or liquid (administered q 12 hours)."
12004751|NCT00555360|Behavioral|HITCM+CP|Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6-month and 12-month follow-up.
12004752|NCT00555360|Behavioral|HITCM only|Weekly automated assessment calls with follow-up by a care manager for 12 months. Baseline, 6-month and 12-month follow-up.
12004753|NCT00555347|Drug|Armodafinil|Dosage 150-250 mg
12004754|NCT00555347|Drug|Placebo|Placebo
12004755|NCT00555334|Procedure|RFA|radiofrequency ablation
12004756|NCT00555334|Drug|lamivudine or entecavir|lamivudine (100mg qd) or entecavir (0.5mg qd) after RFA
12004757|NCT00555321|Drug|Tacrolimus|Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (Long-Term Extension [LTE])
12004758|NCT00555321|Drug|Basiliximab|Intravenous (IV), 20 mg, Day1 and Day 5
12004759|NCT00555321|Drug|Belatacept More Intensive (MI)|"Intravenous (IV),
~10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.
~After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE])"
12004762|NCT00555308|Other|emergency department targeted ultrasound imaging|bedside ultrasound performed by emergency physician to identify hydronephrosis
12004764|NCT00555282|Device|central venous catheter|standard central venous catheter
12004765|NCT00555256|Drug|sunitinib and rapamycin (Drug will be held)|Any toxicity causing a total of 14 days delay of therapy will be considered dose limiting.
12004766|NCT00555243|Procedure|Laparoscopic Simulation training|five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
12004767|NCT00555243|Procedure|Traditional Surgical Education|Traditional surgical teaching (no simulator)
12004768|NCT00555230|Drug|Rosuvastatin|5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
12004769|NCT00555230|Drug|Placebo|5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
12004770|NCT00555217|Drug|losartan|50 or 100mg/day
12004771|NCT00555217|Drug|lisinopril|10, 20 or 40 mg/day
12004772|NCT00555204|Drug|ABT-089|10 mg - capsules once daily for 12 weeks
12004773|NCT00555204|Drug|ABT-089|5 mg - capsules once daily for 12 weeks
12004774|NCT00555204|Drug|ABT-089|15 mg - capsules once daily for 12 weeks
12004775|NCT00555204|Drug|ABT-089|20 mg - capsules once daily for 12 weeks
12004776|NCT00555204|Drug|ABT-089|30 mg - capsules once daily for 12 weeks
12004777|NCT00555204|Drug|ABT-089|35 mg - capsules once daily for 12 weeks
12004778|NCT00555204|Drug|placebo|placebo - capsules once daily for 12 weeks
12004779|NCT00555191|Behavioral|diet restriction|each meal should contain less than 2 gm fructose
12004780|NCT00555165|Device|Telescope prosthesis|Monocular implantation of the telescope prosthesis after cataract extraction
12004781|NCT00555152|Other|Laboratory Biomarker Analysis|Correlative studies
12004782|NCT00555152|Drug|Lapatinib Ditosylate|Given PO
12004783|NCT00555152|Other|Placebo|Given PO
12004784|NCT00555139|Drug|GSK561679 tablet|GSK561679 tablets are white film-coated tablets, containing 200 (milligrams) mg of the free base, GSK561679A.
12004785|NCT00555139|Drug|GW876008 tablet|GW876008 tablets are white to off-white round film-coated tablets, containing 100 mg of GW876008X (free base).
12004786|NCT00555139|Drug|alprazolam|Alprazolam capsules 0.25 mg are hard gelatine capsules containing 1 tablet of commercial alprazolam (Xanax 0.25).
12004787|NCT00555139|Drug|Placebo|GW876008 placebo tablets will visually match the active GW876008 tablets. GSK561679 placebo tablets will visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that will visually match the active but containing only a filler.
12004788|NCT00555126|Device|Forced Air Warming|Warming after Randomization
12004789|NCT00555126|Device|Warming with endovascular catheter + forced air warming|Warming after Randomization
12004790|NCT00555100|Drug|lenalidomide|10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
12004791|NCT00555100|Drug|dexamethasone|40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
12004792|NCT00555087|Drug|Testosterone Undecanoate and/or PDE-5|Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
12004793|NCT00555074|Drug|Sodium Tungstate|Sodium Tungstate, 200 mg BID, oral route during 6 weeks
12004794|NCT00555074|Drug|Placebo|Placebo, BID, oral route during 6 weeks
12004795|NCT00555061|Drug|Retapamulin Ointment, 1%|1% Ointment
12004796|NCT00555048|Biological|alemtuzumab|
12004797|NCT00555048|Drug|busulfan|
12004798|NCT00555048|Drug|cyclophosphamide|
12004799|NCT00555048|Drug|methotrexate|
12004800|NCT00555048|Drug|tacrolimus|
12004801|NCT00555048|Procedure|allogeneic hematopoietic stem cell transplantation|
12004802|NCT00555048|Procedure|peripheral blood stem cell transplantation|
12004803|NCT00555035|Drug|GSK1349572|
12004804|NCT00555022|Drug|GSK1160724|GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.
12004805|NCT00555022|Drug|Tiotropium bromide|Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.
12004806|NCT00555022|Drug|Placebo|Subjects will receive placebo.
12004807|NCT00555009|Drug|Genotropin|Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
12004808|NCT00555009|Drug|Placebo|Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
12004809|NCT00554996|Device|E. coli 83972 coated urinary catheter|E. coli 83972 coated urinary catheter
12004810|NCT00554983|Biological|recombinant birch pollen allergen|subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
12004811|NCT00554983|Biological|placebo|subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
12004812|NCT00554970|Drug|MAP0010 low dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
12004813|NCT00554970|Drug|MAP0010 high dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
12004814|NCT00554970|Drug|Budesonide inhalation suspension 0.25mg|a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
12004815|NCT00554970|Drug|Budesonide inhalation suspension 0.5mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
12004816|NCT00554944|Procedure|Esophageal probe|Near-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, esophageal probe
12004817|NCT00554918|Drug|docetaxel|
12004818|NCT00554918|Drug|prednisolone|
12004819|NCT00554918|Drug|zoledronic acid|
12004820|NCT00554918|Procedure|quality-of-life assessment|
12004821|NCT00554918|Radiation|strontium chloride Sr 89|
12004822|NCT00554905|Procedure|Radiofrequency ablation|For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, California, USA) and a needle electrode with a 15-gauge insulated cannula with 10 hook-shape expandable electrode tines with a diameter of 3.5cm at expansion (LeVeen; RadioTherapeutics, Mountain View, California, USA).
12004823|NCT00554905|Procedure|TACE|TACE first, then RFA within 2 weeks
12004946|NCT00553943|Drug|Rituximab|375 mg/m2 D1
12004824|NCT00554892|Procedure|bowel preparation|oral laxatives, retrograde enemas
12004825|NCT00554892|Procedure|no preparation bowel|no preparation bowel
12004826|NCT00554879|Procedure|Acupuncture|Needles placed bilaterally on the ears at the auriculotherapy points. Additional needles placed in both index fingers. A third set of needles inserted on both index fingers between LI-1 adn LI-2.
12004827|NCT00554879|Procedure|Sham acupuncture|Four needles will be placed on the left and right upper shoulder areas. Small circular adhesive tape will be placed in an ear area, but not on the acupuncture points.
12004828|NCT00554866|Other|blood sample and buccal swab sample|"one blood sample (500 mL) will be obtained from each VLBW infant between 6 and12 hours after birth from an umbilical-artery or peripheral artery catheter.
~Additional DNA collection buccal cell samples were obtained with a sterile OmniSwab."
12004829|NCT00554853|Drug|pioglitazone|daily dose, 30 mg daily for 2 weeks followed by 45 mg daily until completing 3 months unless higher dose not tolerated in which case patient remained at 30 mg daily
12004830|NCT00554853|Drug|Sublingual nitroglycerine|Used during nitroglycerin-mediated dilatation vascular function measures in both arms of the study if patient's blood pressure permitted. One single tablet was used per vascular test performed.
12004831|NCT00554840|Drug|varenicline|Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
12004832|NCT00554840|Drug|placebo|At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
12004833|NCT00554827|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.
~Administered every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
12004834|NCT00554827|Dietary Supplement|Folic Acid|"1 mg orally
~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.
~Administered daily throughout the study and for at least 30 days after last dose of pralatrexate."
12004835|NCT00554827|Drug|Pralatrexate|Intravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or
12004836|NCT00554814|Drug|Bledilait Biofer®|Bledilait Biofer® 2 mg/100 kcal
12004837|NCT00554814|Drug|Milk supplemented with ferrous sulphate|Milk supplemented with ferrous sulphate (2mg/100kcal)
12004838|NCT00554814|Drug|Blédilait Biofer®|Blédilait Biofer® milk (1,1mg/100kcal)
12004839|NCT00554801|Procedure|Audiological testing|Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system.
12004840|NCT00554788|Procedure|Autologous Bone Marrow Transplantation|Undergo peripheral blood stem cell or bone marrow transplant
12004841|NCT00554788|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo peripheral blood stem cell or bone marrow transplant
12004842|NCT00554788|Drug|Carboplatin|Given IV
12004843|NCT00554788|Drug|Cisplatin|Given IV
12004844|NCT00554788|Drug|Cyclophosphamide|Given IV
12004845|NCT00554788|Drug|Etoposide|Given IV
12004846|NCT00554788|Biological|Filgrastim|Given SC
12004847|NCT00554788|Procedure|In Vitro-Treated Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood stem cell or bone marrow transplant
12004848|NCT00554788|Radiation|Radiation Therapy|Undergo radiotherapy
12004849|NCT00554788|Drug|Thiotepa|Given IV
12004850|NCT00554788|Drug|Vincristine Sulfate|Given IV
12004851|NCT00554775|Drug|erlotinib hydrochloride|PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
12004852|NCT00554775|Drug|placebo|WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride
12004853|NCT00554762|Drug|GW842166X|Administer
12004854|NCT00554749|Behavioral|Interventions at home, in the kindergarten/school|Weekly interventions including behavior techniques (stimulus fading)
12004855|NCT00554736|Biological|Lactobacillus acidophilus L-92|Nasal challenge and acoustic rhinometry will be performed at the first study visit and again at the end of the 4-month supplement period. Standardized perennial ryegrass pollen extract (Lolium perenne) (Hollister-Stier, Inc., Spokane, WA) will be used. Dilutions of the standard product will be made in sterile saline prior to use. The standard product strength is 100,000 BAU/mL. Provocation will start with 100 BAU/mL, delivered as a 100 microliter puff into each nostril nose during breath holding, followed by expiration. Acoustic rhinometry, performed in each nostril, will be recorded at 15 minutes. A change of 30% from baseline in the composite score is considered significant. The dose will be increased every 20 minutes if there is no response. The concentrations used will be 100 BAU, 330 BAU, 1000 BAU, 3300 BAU, 10,000 BAU or 33,000 BAU/mL.
12004856|NCT00554723|Drug|NeuroAid|4 capsules 3 times daily, for three months
12004857|NCT00554723|Drug|NeuroAid matched Placebo|NeuroAid matched Placebo, 4 capsules 3 times daily, for three months
12004858|NCT00554710|Drug|infliximab+azathioprine|infliximab 5 mg/kg at week 0,2 and 6 + azathioprine 2-2.5 mg/kg
12004859|NCT00554710|Drug|methylprednisolone or budesonide|methylprednisolone 32 mg followed by taper or budesonide 9 mg/day followed by taper
12004860|NCT00554671|Other|Algorithm driven medication titration|Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
12004861|NCT00554671|Behavioral|Monitoring|Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
12004862|NCT00554671|Behavioral|Group support|Peer support are provided in the group setting
12004863|NCT00554671|Behavioral|Self efficacy|Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision
12004864|NCT00554658|Drug|Quetiapine|Quetiapine will be administered open label as clinically required according to current guidelines. Target dose range: 400 - 800 mg quetiapine per day.
12004865|NCT00554645|Behavioral|multi-disciplinary group intervention|children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months
12004866|NCT00554645|Other|traditional information|1 session of nutritional advise for parents and child and 1 follow-up after one month
12004867|NCT00554632|Drug|Ethinyl estradiol and norgestimate|Oral contraceptive
12004868|NCT00554632|Drug|Ethinyl estradiol and norelgestromin|Transdermal hormonal contraceptive changed weekly
12004869|NCT00554619|Drug|GSK1325760A|2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.
12004870|NCT00554606|Drug|ACZ885|ACZ885
12004871|NCT00554580|Procedure|Continuous Positive Airway Pressure (CPAP)|"Usual treatment of acute pulmonary oedema (see arm A) + CPAP will be administered without interruption for at least one hour and will be stopped for efficacy:
~stade I or II KILLIP classification and FR less or equal to 25 /min and SpO2 larger than 90 % ambient air and patient willing the stop of CPAP because of improvement of his clinical status."
12004872|NCT00554580|Procedure|usual care of acute pulmonary oedema|"Usual treatment of acute pulmonary oedema including :
~Oxygen, diuretic minimum one bolus IV of 40 mg FUROSEMIDE (LASILIX) possibility to repeat the dose every 15 minutes with a maximum 120 mg.
~Bolus of ISOSORBIDE DINITRATE (RISORDAN) of 1 mg maybe repeated every 3 minutes.
~As soon as possible perfusion of ISDN with flow adapted to the clinical status If necessary administration of DOBUTAMINE continuous perfusion of to 5 to 20 µg/kg/min."
12004873|NCT00554567|Behavioral|HIV Testing and Care Services|Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
12004874|NCT00554541|Other|Ankle Brachial Index Venous physiologic study|Assessment of lower extremity venous disease
12004875|NCT00554528|Device|cervical disc prosthesis with a mobile insert named Mobi-C|"Stage 1: partial discectomy
~stage 2: location of the medial axis
~stage 3: centering pin
~stage 4: installation of the caspar spacer
~stage 5: total discectomy
~stage 6: parallel distraction
~stage 7: depth measurement
~stage 8: trial implant
~stage 9: assembly
~stage 10: implant insertion
~stage 11: anchorage optimization"
12004876|NCT00554528|Procedure|arthrodesis - cervical disk surgery|discectomy and arthrodesis
12004877|NCT00554515|Drug|HD IL2|
12004878|NCT00554502|Drug|supportive therapy with: ACE-inhibitor / ARB / Statin|"Antihypertensive therapy with a target blood pressure below 125/75 mmHg (following current clinical guidelines).
~ACE-inhibitors (ARB when an ACE-inhibitor is not tolerated)
~Other antihypertensive medications depending on the clinical decision and following current guidelines.
~Statin therapy
~Dietary counseling for a low-sodium diet and, if GFR is below 60 ml/min, for a protein intake of 0.8 g/kg/day."
12004879|NCT00554502|Drug|supportive and immunosuppressive therapy|"supportive therapy as outlined above
~depending on GFR:
~methylprednisolone and prednisolone
~cyclophosphamide and prednisolone; after 3 months azathioprine with prednisolone
~Concomitant medication with the immunosuppressive treatment following current clinical practice"
12004880|NCT00554489|Behavioral|exercise intervention|participation in physical activity intervention program weeks 2 through 5
12004881|NCT00554476|Drug|Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting|
12004882|NCT00554463|Drug|Filgrastim|5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.
12004883|NCT00554463|Drug|Pegfilgrastim|6 mg via subcutaneous injection days 46 and 67
12004884|NCT00554463|Drug|Etoposide|Concurrent: 120 mg/m^2, IV on days 1-3 and days 22-24. Adjuvant: 120 mg/m^2, IV on days 43-45 and days 65-66.
12004885|NCT00554463|Drug|Cisplatin|Concurrent: 60 mg/m^2, IV on days 1 and 22. Adjuvant: 60 mg/m^2, IV on days 43 and 64.
12004886|NCT00554463|Radiation|radiation therapy|A total of 61.2 Gy in 5 weeks: Once-daily 1.8 Gy fractions for 15 fractions over 3 weeks beginning on day 1 of chemotherapy, then twice-daily 1.8 Gy fractions for 10 fractions over 2 weeks.
12004887|NCT00554450|Drug|Dapagliflozin|Tablets, Oral, once daily
12004888|NCT00554437|Behavioral|UW Falls Prevention Program|The intervention model is of a community-based multifactorial intervention that links participants to existing medical care and service networks. The intervention used an algorithm based on the University of Wisconsin Falls Prevention Clinic, designed to identify predisposing factors for falls; induce risk reduction changes in medical conditions, medications, behavior, physical status, and home environment through recommendations to participants and their physicians; and make sure these changes are long-lasting through follow-up and linkages to other care networks.
12004889|NCT00554424|Drug|lignocaine|20 mls of 1% lignocaine solution for injection, 10mls into each side of upper vagina, under ultrasound guidance immediately prior to transvaginal oocyte retrieval under ultrasound guidance from each ovary
12004890|NCT00554424|Drug|normal saline|20mls of normal saline solution, 10mls injected each side into upper vagina under ultrasound guidance, immediately prior to ultrasound guided transvaginal oocyte retrieval from each ovary
12004891|NCT00554398|Drug|MK-0518 400mg twice a day|Raltegravir, MK-0518
12004892|NCT00554385|Drug|ABT-089|Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
12004893|NCT00554372|Genetic|JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)|Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29.
12004894|NCT00554359|Drug|I5NP (a small interfering RNA)|Single IV injection of experimental drug
12004895|NCT00554359|Drug|placebo|Single IV injection of saline
12004896|NCT00554346|Drug|Arcoxia(etoricoxib 90 mg/tablet)|Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days
12004897|NCT00554333|Biological|Flu-ID 15μg|Inactivated Split-Virion Influenza Vaccine for Intradermal Route
12004898|NCT00554333|Biological|Inactivated adjuvanted Influenza Vaccine|Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
12004947|NCT00553943|Drug|Cytarabine|50 mg D3
12005057|NCT00553202|Drug|tacrolimus|Given IV
12005058|NCT00553202|Other|laboratory biomarker analysis|Correlative studies
12005059|NCT00553202|Other|pharmacological study|Correlative studies
12004899|NCT00554320|Procedure|tDCS|During each session, the anode electrode will be placed on the motor cortex (contralateral to the most [or predominant] painful side [or the side where the symptoms begin or the left as a default]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes.
12004900|NCT00554320|Procedure|tDCS|For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
12004901|NCT00554307|Device|INVOS Cerebral/Somatic oximeter|Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.
12004902|NCT00554294|Behavioral|environmental and behavioral change|In intervention schools a water dispenser was installed and children received water bottles as environmental intervention. Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.
12004903|NCT00554281|Device|Use of glucose sensor (Paradigm Guardian)|Use glucose sensor to prevent episodes of severe hypoglycemia
12004904|NCT00554268|Drug|PBI-05204|Starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle
12004905|NCT00554255|Drug|SB751689|
12004906|NCT00554242|Dietary Supplement|Grape seed extract and ascorbic acid|Grape seed extract 450 mg and ascorbic acid 1500 mg daily
12004907|NCT00554229|Drug|ZD4054|ZD4054 10 mg oral tablet once daily
12004908|NCT00554229|Drug|Placebo|Matching placebo oral tablet once daily
12004909|NCT00554216|Drug|VI-0521|3.75 mg phentermine/23 mg topiramate
12004910|NCT00554216|Drug|VI-0521|15 mg phentermine/92 mg topiramate
12004911|NCT00554216|Drug|Placebo matched phentermine/topiramate|Placebo matched phentermine/topiramate
12004912|NCT00554203|Drug|Sulfasalazine|sulfasalazine 2 grams daily for 6 weeks
12004913|NCT00554190|Device|AdvaCoat sinus gel|A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
12004914|NCT00554190|Device|Merogel Injectable|Bioresorbable hyaluronic acid product
12004915|NCT00554177|Drug|Medicane (mifepristone)|2 doses of 1200mg, Administered 2-3 days apart
12004916|NCT00554177|Drug|Placebo|2 doses of 1200mg, administered 2-3 days apart
12004917|NCT00554164|Drug|(R-)CHOP protocol|Patients with a persistently positive interim-PET scan assigned to arm B1 will receive another six cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone).
12004918|NCT00554164|Drug|B-ALL protocol|Patients with a persistently positive interim-PET scan assigned to arm B2 will receive six blocks of the B-ALL protocol (rituximab, methotrexate, ifosfamide, etoposide, cytarabine, vincristine, cyclophosphamide, doxorubicine, vindesine, dexamethasone).
12004919|NCT00554164|Drug|(R-)CHOP protocol|Patients with a negative interim-PET scan assigned to arm A1 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone). Arm A1 was closed when the number of patients required for the randomisation between arms A1 and A2 was reached.
12004920|NCT00554164|Drug|(R-)CHOP protocol|Patients with a negative interim-PET scan assigned to arm A2 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone) plus two additional doses rituximab. Since the number of patients required for the randomisation between arms A1 and A2 has been reached, all patients with a negative interim-PET scan are treated according to arm A2.
12004921|NCT00554151|Device|Adjustable Annuloplasty Ring|The investigational device is intended for use in the treatment of mitral valve regurgitation.
12004922|NCT00554138|Drug|placebo|1 dd for 7-10 days
12004923|NCT00554138|Drug|rosuvastatin|1 dd 20 mg for 7-10 days
12004924|NCT00554125|Drug|sirolimus|given at an initial dose of 3 mg/m2, and adjusted over time to achieve steady-state whole-blood trough levels of approximately 5-8 ng/mL
12004925|NCT00554112|Behavioral|Exercise|Exercise
12004926|NCT00554099|Drug|Mesalamine|6 - 400 mg tablets once daily
12004927|NCT00554099|Drug|Probiotic|Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
12004928|NCT00554099|Drug|Placebo|6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
12004929|NCT00554099|Other|Dietary Advice|Dietary advice
12004930|NCT00554099|Drug|Antibiotic for Diverticulitis|Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
12004931|NCT00554086|Drug|Escalating dose of Casodex from 50mg daily to 150 mg daily|Casodex dosage increase from 50mg to 150mg daily until baseline serum PSA is reduced by 50%
12004932|NCT00554047|Other|Multidisciplinary Memory Clinic|Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)
12004933|NCT00554047|Other|General Practitioners|Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners
12004934|NCT00554034|Drug|periopatch|Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.
12004935|NCT00554008|Procedure|laparoscopic appendectomy|appendix removal via scope
12004936|NCT00554008|Procedure|open appendectomy|open operation for removal of appendix
12004937|NCT00553995|Drug|salsalate|Salsalate 3-4 grams per day as tolerated for nine days
12004938|NCT00553995|Drug|Placebo|
12004939|NCT00553982|Procedure|Patellar component|Resurfacing with onlay technique
12004940|NCT00553982|Procedure|No patellar component|Trimming of osteophytes when appropriate
12004941|NCT00553969|Drug|carvedilol phosphate|Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
12004942|NCT00553969|Drug|lisinopril|tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
12004943|NCT00553969|Drug|carvedilol phosphate and lisinopril|carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
12004944|NCT00553969|Drug|placebo and placebo|capsule once daily for 9 months; dosage unknown
12004945|NCT00553956|Behavioral|Narrative Exposure Therapy/Interpersonal Psychotherapy|The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.
12004948|NCT00553930|Drug|Pegylated interferon alfa-2a and Ribavirin|All patients will be treated with the combination of pegIFN-α 2a (135 μg per week)plus oral Ribavirin at a dose of 800 mg per day. The treatment will be continued up to 20 weeks after reaching an undetectable plasma RNA-HCV. Treatment will be discontinued for patients who did not achieve a reduction of al least 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 and will be considered as viral failures.
12004949|NCT00553930|Drug|Pegylated interferon alfa 2a and Ribavirin|Pegylated interferon alfa 2a (135 ug/week)and Ribavirin (800 mg/day). Duration: 20 weeks after reaching an undetectable plasma RNA_HCV. Treatment will be discontinued for patients who did not achieve a decrease of >= 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 of treatment or earlier and will be considered as viral failures.
12004950|NCT00553904|Dietary Supplement|Cranberry juice|480 ml of double strength cranberry juice daily for four weeks
12004951|NCT00553891|Drug|mometasone furoate nasal spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.
12004952|NCT00553891|Drug|placebo nasal spray|One spray in each nostril once daily for 3 months.
12004953|NCT00553878|Drug|Dutasteride|dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
12004954|NCT00553865|Drug|OJP-2028|Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.
12004955|NCT00553852|Drug|Recombinant GH Saizen (Merck-Serono)|Treatment will start at the initial dose 0.15-0.30 mg/day; dose adjustment will be performed according to IGF-I levels. The duration of medical treatment is 6 months.
12004956|NCT00553839|Drug|ketamine hydrochloride|Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
12004957|NCT00553813|Drug|TPI 287|Intravenous dose of 125 mg/m2 TPI 287 on Day 1, Day 8, and Day 15 in a repeating 28 day cycle.
12004958|NCT00553800|Drug|bevacizumab|
12004959|NCT00553800|Drug|Erlotinib|
12004960|NCT00553787|Drug|VI-0521|phentermine 15 mg and topiramate 92 mg, po once daily
12004961|NCT00553787|Drug|VI-0521|phentermine 7.5 mg and topiramate 46 mg, po once daily
12004962|NCT00553787|Drug|VI-0521|placebo
12004963|NCT00553774|Dietary Supplement|Cocoa Flavanols|Cocoa Flavanols (BD for 21 - 28 days)
12004964|NCT00553774|Other|Placebo|Placebo (BD 21 - 28 Days)
12004965|NCT00553761|Device|Pattern electroretinogram|Full field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls.
12004966|NCT00553748|Drug|F-18 FLT|One - 10 mci dose of F-18 FLT is administered IV over about 5 seconds prior to PET imaging. Each imaging dose contains no more than 6.1 micrograms of FLT.
12004967|NCT00553735|Drug|Cyclosporine A 0.05%|Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
12004968|NCT00553735|Drug|Arificial Tear|Artificial Tear - three times a day for 18 months.
12004969|NCT00553722|Drug|Eplerenone|Administer Eplerenone, 25 mg,orally twice daily for 4 weeks.
12004970|NCT00553722|Drug|Placebo|Administer a placebo tablet orally twice daily for 4 weeks.
12004971|NCT00553709|Drug|Nicotine|Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)
12004972|NCT00553696|Drug|Cisplatin|Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
12004973|NCT00553696|Drug|S-1|S-1 80 mg/m2 on days 1-21 of each 28 day cycle
12004974|NCT00553696|Drug|Sunitinib|Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
12004975|NCT00553683|Drug|cyclophosphamide|
12004976|NCT00553683|Drug|poly ICLC|
12004977|NCT00553683|Procedure|hepatic artery embolization|
12004978|NCT00553683|Radiation|3-dimensional conformal radiation therapy|
12004979|NCT00553657|Drug|DETROL LA (drug)|
12004980|NCT00553644|Drug|Bortezomib|Given IV
12004981|NCT00553644|Other|Laboratory Biomarker Analysis|Correlative studies
12004982|NCT00553644|Drug|Lenalidomide|Given PO
12004983|NCT00553631|Biological|velaglucerase alfa|IV infusion, 60 U/kg every other week for 9 months
12004984|NCT00553631|Biological|imiglucerase|IV infusion, 60 U/kg every other week for 9 months
12004985|NCT00553618|Drug|Proleukin and Dacarbazine|"IL-2 (Proleukin), injected just under the skin, at a dose of 12 million units on days 1-4 for each of the six months of therapy.
~Dacarbazine, administered as an IV infusion through a freely flowing IV, at a dose of 750 mg, repeated every four weeks."
12004986|NCT00553605|Drug|Ketoprofen 100mg|Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection
12004987|NCT00553605|Drug|Parecoxib 40mg|Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
12004988|NCT00553592|Drug|Bicifadine|600mg/day
12004989|NCT00553592|Drug|Bicifadine|placebo tablet
12004990|NCT00553592|Drug|Bicifadine|1200 mg
12004991|NCT00553566|Procedure|medical chart review|
12004992|NCT00553566|Procedure|questionnaire administration|
12004993|NCT00553566|Procedure|study of socioeconomic and demographic variables|
12004994|NCT00553553|Drug|Morphine sulphate|Intravenous morphine titrated up to 0.25 milligrams/kilogram prior to end of resection phase or within first 2 hours of surgery
12004995|NCT00553553|Drug|Morphine hydrochloride, remifentanil hydrochloride|"Pre-induction intrathecal morphine HCl (< 3 attempts), single shot via 25 G pencil point spinal needle at 10 micrograms/kilogram
~Intra-operative intravenous remifentanil HCl at titratable dose range 0.1-0.25 micrograms/kilogram/minute until start of wound closure"
12005047|NCT00553228|Biological|Tdap|0.5 mL IM once at visit #2
12005048|NCT00553228|Biological|Td|0.5 mL IM once at visit #2
12005049|NCT00553215|Procedure|quality-of-life assessment|
12004996|NCT00553540|Device|Back supports|The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
12004997|NCT00553527|Procedure|Humeral Stem replacement surgery|Patient will receive humeral stem replacement.
12004998|NCT00553514|Drug|AS900672-Enriched 10 microgram (mcg)|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
12004999|NCT00553514|Drug|AS900672-Enriched 20 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
12005000|NCT00553514|Drug|AS900672-Enriched 30 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
12005001|NCT00553514|Drug|AS900672-Enriched 40 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
12005002|NCT00553514|Drug|Follitropin alfa 75 international unit (IU)|Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
12005003|NCT00553514|Drug|Recombinant human chorionic gonadotropin (r-hCG)|Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm).
12005004|NCT00553501|Biological|epratuzumab|Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV
12005005|NCT00553501|Biological|rituximab|Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV
12005006|NCT00553488|Drug|Regular insulin (Humulin)|Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
12005007|NCT00553488|Drug|Insulin lispro (Humalog)|Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
12005008|NCT00553475|Drug|placebo|Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
12005009|NCT00553475|Drug|pregabalin|Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
12005010|NCT00553475|Drug|pregabalin|Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
12005011|NCT00553462|Drug|carboplatin|
12005012|NCT00553462|Drug|erlotinib hydrochloride|
12005013|NCT00553462|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12005014|NCT00553462|Radiation|radiation therapy|
12005015|NCT00553449|Drug|rabeprazole|
12005016|NCT00553436|Device|Tissue Apposition System (TAS) Device|Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.
12005017|NCT00553423|Drug|Lactulose|Lactulose 30 ml q6h for 48 hrs
12005018|NCT00553423|Drug|Placebo|Placebo 30 ml q6hrly for 48 hrs
12005019|NCT00553410|Drug|Letrozole|Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
12005020|NCT00553410|Drug|Letrozole|Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months
12005021|NCT00553371|Other|biomarker analysis|
12005022|NCT00553371|Procedure|computed tomography|
12005023|NCT00553358|Drug|Lapatinib|Small molecule receptor tyrosine kinase inhibitor
12005024|NCT00553358|Biological|Trastuzumab|Therapeutic Monoclonal Antibody
12005025|NCT00553358|Drug|Paclitaxel|antimicrotubule agent
12005026|NCT00553345|Drug|selenium|
12005027|NCT00553345|Drug|vitamin E|
12005028|NCT00553345|Procedure|chemoprevention|
12005029|NCT00553332|Drug|selumetinib|Given orally
12005030|NCT00553332|Other|laboratory biomarker analysis|Correlative studies
12005031|NCT00553319|Drug|Placebo|Placebo group
12005032|NCT00553319|Drug|Adderall-XR|Adderall-XR 60mg/day
12005033|NCT00553319|Drug|Adderall-XR|Adderall-XR 80mg/day
12005034|NCT00553306|Biological|therapeutic autologous lymphocytes|Given IV
12005035|NCT00553306|Biological|aldesleukin|Given subcutaneously
12005036|NCT00553306|Drug|cyclophosphamide|Given IV
12005037|NCT00553306|Procedure|biopsy|Optional correlative studies
12005038|NCT00553306|Other|immunohistochemistry staining method|Optional correlative studies
12005039|NCT00553306|Other|flow cytometry|Correlative studies
12005040|NCT00553306|Genetic|polymerase chain reaction|Correlative studies
12005041|NCT00553293|Drug|recombinant luteinizing hormone (Luveris)|75 iu/day form cycle day 6
12005042|NCT00553293|Drug|recombinant follicle stimulating hormone (Gonal-f)|rFSH 150 iu/day
12005043|NCT00553280|Drug|pregabalin|Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
12005044|NCT00553267|Drug|fixed dose combination of telmisartan+amlodipine|
12005045|NCT00553267|Drug|amlodipine|
12005046|NCT00553254|Drug|PF-00299804|Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent
12005060|NCT00553202|Procedure|allogeneic bone marrow transplantation|allogeneic bone marrow transplantation
12005061|NCT00553202|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic hematopoietic SCT
12005062|NCT00553189|Drug|ABT-888|
12005063|NCT00553189|Drug|Topotecan|
12005064|NCT00553176|Other|No intervention|At six-month intervals (January and July), physicians will document disease characteristics, changes in Crohn's therapy, disease progression, key events, the use of ancillary services, and hospitalizations
12005065|NCT00553163|Behavioral|Gut focussed hypnotherapy|Gut focussed hypnotherapy
12005066|NCT00553163|Behavioral|Control educational sessions|Control educational sessions
12005067|NCT00553150|Drug|everolimus|
12005068|NCT00553150|Drug|temozolomide|
12005069|NCT00553150|Radiation|radiation|
12005070|NCT00553137|Drug|fluconazole|750 mg (5 tablets of 150 mg tablets)taken once
12005071|NCT00553137|Drug|fluconazole|150 mg fluconazole tablets once daily for 14 days
12005072|NCT00553124|Drug|selenium|
12005073|NCT00553124|Drug|vitamin E|
12005074|NCT00553124|Procedure|biopsy|
12005075|NCT00553124|Procedure|chemoprevention|
12005076|NCT00553124|Procedure|cryopreservation|
12005077|NCT00553124|Procedure|cytology specimen collection procedure|
12005078|NCT00553124|Procedure|diagnostic procedure|
12005079|NCT00553124|Procedure|gene expression analysis|
12005080|NCT00553124|Procedure|immunohistochemistry staining method|
12005081|NCT00553124|Procedure|laboratory biomarker analysis|
12005082|NCT00553124|Procedure|medical chart review|
12005083|NCT00553124|Procedure|mutation analysis|
12005084|NCT00553124|Procedure|polymerase chain reaction|
12005085|NCT00553124|Procedure|quality-of-life assessment|
12005086|NCT00553124|Procedure|questionnaire administration|
12005087|NCT00553124|Procedure|study of socioeconomic and demographic variables|
12005088|NCT00553111|Other|educational video|educational video
12005089|NCT00553098|Biological|Alemtuzumab|Given IV
12005090|NCT00553098|Procedure|Allogeneic Bone Marrow Transplantation|Undergo HCT
12005091|NCT00553098|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HCT
12005092|NCT00553098|Drug|Cyclosporine|Given PO or IV
12005093|NCT00553098|Drug|Fludarabine Phosphate|Given IV
12005094|NCT00553098|Other|Laboratory Biomarker Analysis|Correlative study
12005095|NCT00553098|Drug|Mycophenolate Mofetil|Given PO or IV
12005096|NCT00553098|Radiation|Total-Body Irradiation|Undergo low dose TBI
12005097|NCT00553072|Drug|Magnesium sulphate|250 mg/kg/dose in 1 ml normal saline
12005098|NCT00553072|Drug|Normal saline|1 ml/kg/dose
12005099|NCT00553059|Drug|dexamethasone|10 mg IV 30 minutes prior to administration of chemotherapy
12005100|NCT00553059|Drug|dronabinol|5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy
12005101|NCT00553059|Drug|palonosetron hydrochloride|0.25 mg IV 30 minutes prior to administration of chemotherapy
12005102|NCT00553059|Other|placebo|1 tablet by mouth three times a day beginning 30 minutes before chemotherapy
12005103|NCT00553046|Other|survey administration|application of a family survey on last 3 months of life for their relatives under HMV
12005104|NCT00553033|Procedure|Laparoscopic liver surgery|Ultrasonic dissector, harmonic scalpel
12005105|NCT00553020|Drug|Insulin glargine|"Lantus (commercial formulation, Reference):
~10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)
~NPH-insulin (Protaphan) (Test):
~10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)"
12005106|NCT00553007|Procedure|Periodontal therapy|Normal periodontal therapy is performed.
12005107|NCT00552994|Device|Cypher Select plus|Drug eluting stent
12005108|NCT00552994|Device|Xience V stent|Drug eluting stent
12005109|NCT00552981|Procedure|inhalation of warm air in a Finnish sauna|three times on three following days, each 2-3 minutes
12005110|NCT00552981|Procedure|inhalation of ambient air in a Finnish sauna|three times on three following days, each 2-3 minutes
12005111|NCT00552942|Procedure|laparoscopic gastric bypass plus omentectomy|
12005112|NCT00552929|Drug|Sugammadex|"After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered."
12005113|NCT00552916|Device|Compex Motion Stimulator|'True' Functional Electrical Stimulation Assisted Walking
12005114|NCT00552916|Device|Compex Motion Stimulator|'False' FES
12005115|NCT00552903|Behavioral|Health coaching|Personal health coach providing advice and counselling by telephone, weekly contacts
12005116|NCT00552890|Other|modified Atkins diet|subjects assigned to follow modified Atkins diet for 1 year
12005117|NCT00552890|Other|ADA recommended diet|subjects assigned to follow ADA recommended diet for period of 1 year
12005118|NCT00552877|Device|Percutaneous coronary intervention (Xience V stent)|Cypher Select plus coronary stent Xience V coronary stent
12005119|NCT00552864|Drug|Ropivacaine|0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.
12005155|NCT00552578|Drug|buprenorphine/naloxone|sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response)
12005156|NCT00552578|Drug|buprenorphine/naloxone|sublingual tablets, 2/0.5 mg, one tablet three times a day for six months (doses may be adjusted based on an individual's response
12005120|NCT00552864|Drug|Levobupivacaine|0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.
12005121|NCT00552851|Drug|pegvisomant|booster dosage 80 mg once sc., than 10 mg once per day, uptitration in steps of 5 mg up to an IGF-1 level in the normal range (every 4 weeks), max. 30 mg once per day. Duration of treatment: one year
12005122|NCT00552838|Behavioral|Academic Detailing by the Antimicrobial Utilization Team (AUT)|Physicians caring for patients who were prescribed one of three antimicrobials were randomly assigned to academic detailing by the AUT. The AUT would review the antimicrobial prescription and provide consultation to the ordering physician if the prescription is appropriate and provide feedback on a better alternative if inappropriate.
12005123|NCT00552812|Device|Stent therapy of aortic coarctation|Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
12005124|NCT00552799|Drug|Penicillin VK|Biconcave tablet 250mg oral, b.d.
12005125|NCT00552799|Other|placebo|biconcave tablet matching active comparator as much as possible in size and shape
12005126|NCT00552786|Drug|N-acetylcysteine (NAC)|600mg twice daily for 2 weeks
12005127|NCT00552786|Drug|glucose|1 gm glucose capsule
12005128|NCT00552773|Drug|Cyclamen Europaeum|Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
12005129|NCT00552760|Drug|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
12005130|NCT00552760|Drug|Placebo|one tablet at bedtime for up to 6 months
12005131|NCT00552747|Drug|fenofibrate|fenofibrate 160 mg capsules qd
12005132|NCT00552747|Drug|placebo|capsules placebo
12005133|NCT00552734|Device|Insulin Guidance Software|At baseline a healthcare provider reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event.
12005134|NCT00552721|Other|Physical therapy with strength training|12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.
12005135|NCT00552721|Other|Physical therapy without strength training|12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.
12005136|NCT00552708|Drug|COREG CR|
12005137|NCT00552708|Drug|Lisinopril|
12005138|NCT00552695|Device|Lidocaine tetracaine|Lidocaine 70 mg/tetracaine 70 mg
12005139|NCT00552695|Device|Placebo|Placebo patch identical in appearance to Synera
12005140|NCT00552682|Drug|Duloxetine 60 mg, QD|Duloxetine 60 mg, 1 table/day, 1 year
12005141|NCT00552669|Drug|Oral sirolimus|Oral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .
12005142|NCT00552669|Device|Drug Eluting stent|Any Drug eluting stent
12005143|NCT00552656|Device|Firebird(TM) Sirolimus-Eluting Stent|balloon expandable stent that made of stainless steel.The length is from 13mm-33mm,and the diameter from 2.5mm-4.0mm
12005144|NCT00552643|Device|Suspension of polystyrene beads (POLYHEAL 1)|Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle
12005145|NCT00552643|Device|Saline (0.9% NaCl)|Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle
12005146|NCT00552630|Device|d-penicillamine|d-penicillamine twice daily, 15 mg/kg/day, for 6 weeks
12005147|NCT00552630|Drug|placebo|placebo with same characteristics as drug
12005148|NCT00552617|Drug|Sugammadex|"After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered"
12005149|NCT00552617|Drug|Placebo|"After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of Placebo IV was administered"
12005150|NCT00552617|Drug|Rocuronium|"After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary."
12005151|NCT00552617|Drug|Vecuronium|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
12005152|NCT00552604|Drug|standardized cannabis extract|Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily
12005153|NCT00552604|Drug|Placebo|Matching placebo capsules, twice daily
12005154|NCT00552591|Behavioral|12-week risk reduction program, managed by a Heart Health Educator|The educator and participant will negotiate a personal plan for achieving the goals through lifestyle change (i.e. smoking cessation, increased exercise, improved nutrition) and, if necessary, pharmacotherapy coordinated by the participant's personal physician. Educational modules have been developed to address specific lifestyle issues including smoking cessation, healthy eating, exercise, and weight management, and will be provided to participants as required. A summary of the risk factor profile and personal plan will be incorporated into a report for the participant's personal physician as well. Participants will also receive telephone-based motivational counseling sessions for 12 weeks to address specific lifestyle issues.
12005157|NCT00552565|Drug|Rezular 15mg|Oral Tablets
12005159|NCT00552565|Drug|Rezular|Rezular 37.5mg 3xday up to 12 weeks
12005160|NCT00552565|Drug|Rezular|Rezular 75mg 3xday up to 12 weeks
12005161|NCT00552552|Behavioral|Fatigue Patient Education Program (FIBS)|6 weekly sessions, 90 min each
12005162|NCT00552552|Behavioral|Fatigue Patient Education Program (FIBS)|Participation in the program after the second follow-up
12005163|NCT00552539|Other|'educational video'|'educational video'
12005164|NCT00552526|Dietary Supplement|Ketogenic diet|Ketogenic diet is a very strict high fat diet
12005165|NCT00552526|Drug|Antiepileptic drug (AED)|An AED,not used by the patient before, which we consider to be the most appropriate will be given orally or by gastrostomy. Serum concentration, the body weight, side effects and effects on the epilepsy will be considered when deciding the dose of the AED. Traditions for amount of medicine/kg body weight or optimal serum concentration at our center will be followed. This tradition will be the same as in other major European epilepsy centers but might propose lower, but not higher amounts than recommended by the drug company. Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate, zonisamide, vigabatrin, tiagabil, lamotrigine, pregabalin, rufinamide, clobazam, clonazepam, tiagabine, gabapentin, phenytoin, phenobarbital, ethosuximide, acetazolamide, nitrazepam and other new antiepileptic drugs that might be released during the study period.
12005166|NCT00552513|Procedure|Early Coronary Intervention|Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (and within 24 hours of randomisation).
12005167|NCT00552513|Procedure|Delayed Coronary Intervention|Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
12005168|NCT00552500|Drug|Depakote (valproate)|500 mg -2000 mg QD based on individual tolerance and VPA levels
12005169|NCT00552487|Drug|synacthen|1 µg synacthen in the vein
12005170|NCT00552474|Device|Libra Deep Brain Stimulation System|Active DBS Therapy
12005171|NCT00552474|Device|Libra Deep Brain Stimulation System|Implanted system but no stimulation
12005172|NCT00552461|Drug|rituximab|IV, 1000 mg, two weeks, 2 times
12005173|NCT00552448|Device|High Frequency Chest Compression VEST|every 6 hours for 20 minutes
12005174|NCT00552435|Device|Laser photocoagulation|Laser therapy is applied using a slit lamp and specific laser contact lens.
12005175|NCT00552422|Drug|domperidone|10mg orally four times per day
12005176|NCT00552409|Dietary Supplement|Cholecalciferol|2000 IU by mouth daily for one year
12005177|NCT00552409|Dietary Supplement|Placebo|One softgel daily for one year
12005178|NCT00552396|Drug|Anti-KIR (1-7F9)|human monoclonal antibody
12005179|NCT00552383|Procedure|NIDCAP based developmental care|"Infants in the intervention arm will receive care in the NICU by nursing staff who have received basic education in NIDCAP - based developmental care. They will also have NIDCAP behavioural observations performed by NIDCAP - Certified staff [this includes 3 of the investigators], at intervals during their stay at the study site NICU. These behavioural observations form the basis for behaviourally guided baby -friendly care, so that the timing and pace of caregiving is synchronised to the infant's readiness. Parents are actively encouraged to become the infant's primary caregiver in the NICU."
12005180|NCT00552370|Drug|Lantus®|
12005181|NCT00552344|Biological|Cimzia|"Active substance: Certolizumab Pegol
~Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe
~Concentration: 200 mg/ml
~Route of Administration: Subcutaneous use"
12005182|NCT00552331|Device|Plates to treat fractures of the distal femur|use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures
12005183|NCT00552331|Device|LISS|treatment of distal femur fractures with less invasive stabilization systems
12005184|NCT00552305|Drug|lacosamide|50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
12005185|NCT00552279|Biological|Cervarix TM|Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
12005186|NCT00552279|Biological|Cervarix TM|Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
12005187|NCT00552266|Drug|Methylphenidate|tablets 10-60 mg/day administered once or twice daily 6 weeks
12005188|NCT00552253|Drug|Levothyroxin treatment|Levothyroxin 100 micogram will be administered once daily 1 hour before meal of just after meal for 3 months, and the dose will be titrate to keep serum TSH level between 0.1~0.3 mU/L. It will be discontinued for 3 months. Then
12005189|NCT00552240|Drug|tenofovir DF 300 mg QD|300 mg QD
12005190|NCT00552240|Drug|tenofovir DF 300 mg QD|300 mg QD
12005191|NCT00552240|Drug|emtricitabine 200 mg QD|200 mg QD
12005192|NCT00552240|Drug|emtricitabine 200 mg QD|200 mg QD
12005193|NCT00552240|Drug|Nevirapine 200 mg BID|200 mg BID
12005194|NCT00552240|Drug|Atazanavir 300 mg|300 mg QD
12005195|NCT00552240|Drug|Ritonavir 100 mg|100 mg QD
12005196|NCT00552227|Drug|ruboxistaurin|oral 32 mg daily
12005197|NCT00552227|Other|placebo|placebo
12005198|NCT00552214|Device|Blood test|Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
12005199|NCT00552201|Drug|Tacrolimus|Administration Twice a day after adjustment to blood level
12005200|NCT00552188|Drug|VIA-2291|100 mg, oral dosing, 1 time daily for 24 weeks
12005201|NCT00552188|Drug|Placebo|oral dosing, 1 time daily for 24 weeks
12005202|NCT00552175|Drug|Duloxetine hydrochloride - 40 mg|duloxetine 40 mg taken orally every day
12005203|NCT00552175|Drug|placebo|placebo taken orally every day
12005204|NCT00552175|Drug|Duloxetine hydrochloride - 60 mg|duloxetine 60 mg taken orally every day
12005205|NCT00552162|Procedure|NOTES Transvaginal Cholecystectomy|The gallbladder will be dissected free and will be removed through an incision in the vagina.
12005206|NCT00552162|Procedure|NOTES Transvaginal Appendectomy|The appendix will be dissected free and will be removed through an incision in the vagina.
12005248|NCT00551876|Drug|MK0653, ezetimibe / Duration of Treatment: 30 Weeks|
12005249|NCT00551876|Drug|Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks|
12005207|NCT00552149|Drug|Gemox, Cetuximab|"GEMOX (Arms 1 and 2), every two weeks:
~Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h
~Cetuximab (ErbituxÒ) (Arm B only) every two weeks:
~(chemotherapy will be started one hour after the end of the cetuximab infusion).
~Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes"
12005208|NCT00552136|Procedure|Ankle Arthroplasty|
12005209|NCT00552136|Procedure|Ankle Arthrodesis|
12005210|NCT00552110|Drug|OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)|MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).
12005211|NCT00552110|Drug|OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)|MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.
12005212|NCT00552110|Drug|mometasone furoate nasal spray (MFNS) once daily|MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.
12005213|NCT00552110|Drug|oxymetazoline nasal spray (OXY) twice daily|OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.
12005214|NCT00552110|Drug|Placebo|Matching placebo to MFNS given every morning and every evening x 2 weeks.
12005215|NCT00552097|Drug|ezetimibe (plus simvastatin)|oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
12005216|NCT00552097|Drug|placebo (plus simvastatin)|tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
12005217|NCT00552084|Drug|Fish oil|Fish oil supplements 4 gms will be taken daily for 24 weeks.
12005218|NCT00552084|Drug|Placebo|Placebo supplements will be taken daily for 24 weeks.
12005219|NCT00552071|Drug|Octreotide LAR 30 MG Injection|Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.
12005220|NCT00552058|Biological|certolizumab pegol (CDP870, CZP)|Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
12005221|NCT00552058|Other|Placebo|Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
12005222|NCT00552032|Drug|Mometasone Furoate nasal spray|Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
12005223|NCT00552032|Drug|Placebo|Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
12005224|NCT00552006|Behavioral|Narrative Exposure Therapy|"Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography.
~NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner."
12005225|NCT00552006|Behavioral|Academic Counseling|"Missing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction.
~AC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner."
12005226|NCT00551993|Procedure|robotic laparoscopic sacrocolpopexy|Da Vinci Robot
12005227|NCT00551993|Procedure|Laparoscopic Sacral Colpopexy|Standard laparoscopy
12005228|NCT00551980|Behavioral|Cognitive, Relaxation, Exercise Therapy|The intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce hyperfunction of the craniofacial and cervical muscles during the day
12005229|NCT00551967|Procedure|Hip replacement|Surgical implantation of hip replacement components for the treatment of osteoarthritis
12005230|NCT00551954|Drug|acarbose|100 mg (tablets) t.i.d.
12005231|NCT00551954|Drug|placebo|one tablet t.i.d.
12005232|NCT00551941|Procedure|BMP-7 in adjunct to fresh frozen allograft|non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft
12005233|NCT00551941|Procedure|allograft together with DBM|non-union of diaphysary tibial fractures treated with allograft together with DBM
12005234|NCT00551928|Drug|Melphalan|High dose Melphalan 200mg/sm with autologous stem cell support
12005235|NCT00551928|Drug|Lenalidomide|Six months of oral therapy with Lenalidomide 10mg/day given 21 days in every 28 days cycle with the combination ofMelphalan and steroids (day 22 to 28), for 6 cycles every 28 days.
12005236|NCT00551928|Drug|Prednisone|Given orally at the dose of 2 mg/Kg for 4 days followed by a 24 day rest period (days 5 to 28), for 6 cycles every 28 days
12005237|NCT00551928|Drug|Melphalan|Melphalan will be given orally at the dose of 0.18 mg/Kg for 4 days, followed by a 24 days rest period (day 5 to 28)for 6 cycles every 28 days
12005238|NCT00551915|Biological|AR51 (12, 10)|vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg
12005239|NCT00551915|Biological|PR51 (3, 10)|vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg
12005240|NCT00551915|Biological|PR51 (6, 10)|vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
12005241|NCT00551915|Biological|PENTACEL™|licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label
12005242|NCT00551915|Biological|RECOMBIVAX HB™|licensed vaccine for hepatitis, administered open-label
12005243|NCT00551902|Procedure|Trabeculectomy with anterior chamber infusion system|Trabeculectomy with anterior chamber infusion system
12005244|NCT00551902|Procedure|Trabeculectomy without anterior chamber infusion system|Standard trabeculectomy surgery
12005245|NCT00551889|Drug|celecoxib|
12005246|NCT00551889|Drug|cyclophosphamide|
12005247|NCT00551889|Other|laboratory biomarker analysis|
12005250|NCT00551863|Behavioral|IVPT|Violence prevention intervention based on Motivational Interviewing and CBT
12005251|NCT00551850|Drug|AV-412|oral solid dosage form administered three times weekly for 4 weeks (1 cycle)
12005252|NCT00551824|Drug|Mitomycin C|Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.
12005253|NCT00551811|Drug|SB-656933-AAA|SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.
12005254|NCT00551811|Drug|Placebo|Placebo tablets will be intended to be administered orally.
12005255|NCT00551798|Procedure|TEP au MIBI|Intravenous injection of MIBI.The review lasted 30 min, during which the patient should not move.
12005256|NCT00551772|Drug|SB-742457|
12005257|NCT00551759|Drug|5-Fluorouracil|given IV
12005258|NCT00551759|Drug|Oxaliplatin|given IV
12005259|NCT00551759|Drug|Cetuximab|given IV
12005260|NCT00551759|Drug|Docetaxel|given IV
12005261|NCT00551759|Procedure|Surgery|Patients underwent surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab.
12005262|NCT00551759|Radiation|Radiotherapy|Patients underwent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33.
12005263|NCT00551746|Dietary Supplement|Purple Grape Juice|Grape Juice
12005264|NCT00551733|Drug|carboplatin|Given IV
12005265|NCT00551733|Drug|paclitaxel|Given IV
12005266|NCT00551733|Drug|paclitaxel poliglumex|Given IV
12005267|NCT00551720|Behavioral|Standard Care|Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch
12005268|NCT00551720|Behavioral|Motivational Enhancement|Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.
12005269|NCT00551707|Drug|CRx-102 (2.7/180)|prednisolone 2.7 mg plus dipyridamole 180 mg
12005270|NCT00551707|Drug|prednisolone|prednisolone (2.7 mg)
12005271|NCT00551707|Drug|dipyridamole|dipyridamole 360 mg
12005272|NCT00551707|Drug|placebo|placebo
12005273|NCT00551707|Drug|CRx-102 (2.7/360)|Prednisolone 2.7 mg plus Dipyridamole 360 mg
12005274|NCT00551694|Drug|GSK256073A tablets|
12005275|NCT00551681|Device|biventricular pacemaker with epicardial left ventricular lead|epicardial left ventricular lead placement
12005276|NCT00551681|Device|transvenous left ventricular lead placement|implantation of biventricular pacemaker with transvenous left ventricular lead placement
12005277|NCT00551668|Procedure|proximal patellar surgery|Initial proximal patellar surgery
12005278|NCT00551668|Procedure|Nonoperative|Nonoperative without surgery
12005279|NCT00551642|Drug|Nitric Oxide for inhalation|inhaled nitric oxide given at 5 parts per million (ppm) for 7-21 days
12005280|NCT00551642|Drug|Nitrogen|nitrogen gas given at 5ppm for 7-21 days
12005281|NCT00551629|Biological|AR51 (12, 10)|vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg
12005282|NCT00551629|Biological|PR51 (3, 10)|vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg
12005283|NCT00551629|Biological|PR51 (6, 10)|vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
12005284|NCT00551629|Biological|PR51 (6, 15)|vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
12005285|NCT00551616|Drug|CDB-2914|Single dose
12005286|NCT00551616|Drug|Levonorgestrel|Single dose
12005287|NCT00551603|Drug|switch (epoetinum beta, darbepoetinum)|switching from epoetinum beta once weekly to once-fortnightly darbepoetinum
12005288|NCT00551603|Drug|continuation (darbepoetinum)|continuation of the previous darbepoetinum administration schedule
12005289|NCT00551590|Drug|Placebo tablet|placebo PO (placebo control for sitagliptin) for three days
12005290|NCT00551590|Drug|Sitagliptin tablet|Sitagliptin 100 mg PO for three days.
12005291|NCT00551590|Drug|Saline infusion|Saline IV (placebo control for exendin(9-39)) on two consecutive study days
12005292|NCT00551590|Drug|Exendin(9-39) infusion|Exendin(9-39) IV on two consecutive study days.
12005293|NCT00551577|Procedure|neoadjuvant chemotherapy (Carboplatin/Docetaxel)|3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
12005294|NCT00551577|Procedure|neoadjuvant chemotherapy (Carboplatin/Docetaxel)|2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
12005295|NCT00551564|Drug|rosiglitazone maleate|Rosiglitazone tablets 4 mg dose will be administered orally by subjects
12005296|NCT00551551|Other|Pelvic floor muscle training with physiotherapist|8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife
12005297|NCT00551551|Other|Written information about kegel exercises|Information about pelvic floor disorders prevention with personal pelvic floor exercises
12005298|NCT00551538|Drug|Lispro mix 75/25|Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
12005299|NCT00551538|Drug|Glargine|SC injection, once-daily, given in conjunction with oral antidiabetic medications.
12005300|NCT00551525|Radiation|Radiotherapy|3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks.
12005301|NCT00551525|Drug|Samarium 153|Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.
12005302|NCT00551512|Drug|CBP501 and Cisplatin|CBP501 is given IV on Day 1 of each cycle (every 21 days). Dose escalation of CBP501 and cisplatin will be starting doses of 3.6 mg/m² CBP501 and 50 mg/m² cisplatin (Dose Level 1). Step 1, if during the first 2 cycles, at least 2 out of 3 to 6 patients experience Dose Limiting Toxicity (DLT) at 50 mg/m² cisplatin, then the cisplatin dose will be de-escalated to 30 mg/m². If no more than 1 out of 6 patients experiences DLT, cisplatin dose will be escalated to 75 mg/m². Step 2, dose escalation will be performed using the cisplatin MTD, with escalating CBP501 doses. CBP501 dose escalation will take place until the MTD has been defined or 74 mg/m² is reached.
12005303|NCT00551499|Device|CRT + AOP|The CSA group will undergo 2 sleep evaluation on two consecutive nights, during which the device will be programmed according to the randomization scheme (one night CRT, DDD/45 and the other CRT, DDD/15 bpm over mean nocturnal heart rate). The mean nocturnal heart rate over the last week is derived from the device memory.
12005304|NCT00551486|Procedure|ultrasound-guided fine needle aspiration biopsy|Fine needle aspiration (FNA)with cytologic analysis has become a mainstay of thyroid nodule evaluation was used. Nonpalpable nodules were aspirated under ultrasound guidance to facilitate precise targeting of the nodule and to sample the part most likely to improve diagnostic yield.
12005305|NCT00551473|Drug|Lavoltidine|
12005306|NCT00551460|Drug|arsenic trioxide|
12005307|NCT00551460|Drug|gemtuzumab ozogamicin|
12005308|NCT00551460|Drug|mercaptopurine|
12005309|NCT00551460|Drug|methotrexate|
12005310|NCT00551460|Drug|tretinoin|
12005311|NCT00551447|Drug|MK0653, ezetimibe / Duration of Treatment: 27 Weeks|
12005312|NCT00551447|Drug|MK0733, simvastatin / Duration of Treatment: 27 Weeks|
12005313|NCT00551447|Drug|Comparator: simvastatin / Duration of Treatment: 27 Weeks|
12005314|NCT00551434|Dietary Supplement|Creatine|Creatine 21 g daily
12005315|NCT00551434|Dietary Supplement|L-arginine and creatine|L-arginine
12005316|NCT00551434|Dietary Supplement|l-arginine|l-arginine 9 g daily
12005317|NCT00551434|Dietary Supplement|placebo, double|placebo
12005318|NCT00551421|Biological|pertuzumab|Given IV
12005319|NCT00551421|Biological|cetuximab|Given IV
12005320|NCT00551421|Drug|irinotecan hydrochloride|Given IV
12005321|NCT00551421|Other|immunohistochemistry staining method|Correlative study
12005322|NCT00551421|Other|fluorescence in situ hybridization|Correlative study
12005323|NCT00551421|Other|gene expression analysis|Correlative study
12005324|NCT00551421|Other|mutation analysis|Correlative study
12005325|NCT00551421|Other|polymerase chain reaction|Correlative study
12005326|NCT00551421|Other|laboratory biomarker analysis|Correlative study
12005327|NCT00551395|Procedure|selective laser trabeculoplasty - early completion|180 degrees of laser on day 1 and other 180 degrees on day 2.
12005328|NCT00551395|Procedure|Selective laser trabeculoplasty - late completion|180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.
12005329|NCT00551382|Drug|Muntelukast|Tablets or granules; 4 mg once a day for 12 weeks
12005330|NCT00551382|Drug|Placebo|Look alike tablets or granules 1 per day for 12 weeks
12005331|NCT00551369|Radiation|SBRT|SBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
12005332|NCT00551356|Drug|Insulin lispro mix 25|Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.
12005333|NCT00551356|Drug|Glargine|Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
12005334|NCT00551343|Drug|Exenatide|10ug Exenatide single s.c. injection
12005335|NCT00551330|Drug|Vicriviroc|One tablet of vicriviroc 30 mg once daily
12005336|NCT00551330|Drug|Placebo|One tablet of placebo once daily
12005337|NCT00551317|Drug|Darapladib (SB480848)|
12005338|NCT00551304|Device|Ardian Catheter|
12005339|NCT00551291|Drug|Mycophenolate mofetil|1 gm twice daily orally until end of study.
12005340|NCT00551291|Drug|Prednisone|10 mg/day orally until end of study.
12005341|NCT00551291|Drug|Erythropoietin Beta|Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.
12005342|NCT00551278|Device|GeneSearch™ Breast Lymph Node (BLN) Assay|"For in vitro diagnostic use only.
~The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes.
~Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required."
12005343|NCT00551265|Drug|Cyclophosphamide|Given IV
12005344|NCT00551265|Procedure|Laboratory Biomarker Analysis|Correlative studies
12005345|NCT00551265|Biological|Oregovomab|Given IV
12005346|NCT00551252|Drug|Imatinib mesylate plus Gemcitabine|Imatinib (400 mg daily) + Gemcitabine (500 mg/sqm, days 1 and 8 every 21 days) for a maximum of 6 cycles
12005347|NCT00551239|Biological|rituximab|Given IV
12005348|NCT00551239|Drug|fludarabine phosphate|Given IV
12005349|NCT00551239|Drug|pixantrone dimaleate|Given IV
12005350|NCT00551213|Biological|Robatumumab|
12005351|NCT00551213|Drug|Irinotecan|
12005352|NCT00551213|Biological|Cetuximab|
12005353|NCT00551213|Drug|Capecitabine|
12005354|NCT00551213|Drug|FOLFOX|Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX)
12005355|NCT00551213|Drug|CAPEOX/XELOX|Capecitabine (CAPE) or Xeloda® (XEL) + oxaliplatin (OX)
12005356|NCT00551213|Drug|FOLFIRI|Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ irinotecan (IRI)
12005357|NCT00551200|Drug|HPN-100|Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
12005358|NCT00551200|Drug|BUPHENYL®|BUPHENYL® (sodium phenylbutyrate) tablets and powder have been approved for marketing in the United States since 1996 as an adjunctive therapy in the long-term management of patients with UCDs involving deficiencies of CPS, OTC, or ASS.
12005359|NCT00551187|Biological|V504|V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
12005360|NCT00551187|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
12005361|NCT00551187|Biological|Comparator: Placebo (unspecified)|V504 Placebo in 3 dose regimen for 6 month treatment period.
12005487|NCT00550628|Genetic|gene expression analysis|
12005488|NCT00550628|Genetic|polymerase chain reaction|
12005362|NCT00551174|Drug|ibandronate [Bonviva/Boniva]|3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
12005363|NCT00551174|Drug|ibandronate [Bonviva/Boniva]|2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
12005364|NCT00551161|Drug|memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 10 mg orally b.i.d., in addition to their ongoing stable cholinesterase inhibitor treatment
12005365|NCT00551148|Drug|PD 0200390|oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
12005366|NCT00551148|Drug|PD 0200390|oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
12005367|NCT00551148|Drug|PD 0200390|oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
12005368|NCT00551148|Drug|PD 0200390|oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
12005369|NCT00551148|Other|Placebo|oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
12005370|NCT00551135|Drug|Pregabalin|150 mg BID
12005371|NCT00551135|Drug|placebo|Placebo
12005372|NCT00551135|Drug|Pregabalin|75 mg BID
12005373|NCT00551135|Drug|Pregabalin|25 mg BID
12005374|NCT00551122|Biological|filgrastim|
12005375|NCT00551122|Biological|lenograstim|
12005376|NCT00551122|Biological|pegfilgrastim|
12005377|NCT00551122|Drug|cisplatin|
12005378|NCT00551122|Drug|gemcitabine hydrochloride|
12005379|NCT00551122|Drug|ifosfamide|
12005380|NCT00551122|Drug|paclitaxel|
12005381|NCT00551109|Drug|placebo|placebo, oral administration, once daily for 8 weeks
12005382|NCT00551109|Drug|SA4503 Low|Low dose, oral administration, once daily for 8 weeks
12005383|NCT00551109|Drug|SA4503 High|High dose, oral administration, once daily for 8 weeks
12005384|NCT00551096|Drug|Gemcitabine|Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2.
12005385|NCT00551096|Drug|Capecitabine|Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off.
12005386|NCT00551096|Drug|ZD6474|Administered orally at 300 mg/day once daily. One cycle will consist of 28 days
12005387|NCT00551083|Other|Computerized Decision Support System for Depression (CDSS-D)|The CDSS for depression was based on an up-to-date model of the Texas Medication Algorithm Project that employs the principles of Measurement Based Care (MBC), while at the same time having a user interface for providers that is easy-to-use. MBC is the systematic use of measuring clinical outcomes at routine visits to guide treatment management. These outcomes may include symptoms, side effects, and medication adherence. Recent efforts from the large, multi-site effectiveness study, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), show that a treatment plan guided by MBC is integral in implementing algorithm based care.
12005388|NCT00551083|Other|Usual Care (UC)|"Usual Care was up to the discretion of the study physician and the patient treated. These physicians were provided with up-to-date treatment protocols for depression, but were not instructed to strictly adhere to a treatment algorithm. Therefore, they treated depressed patients as they usually would."
12005389|NCT00551070|Other|Laboratory Biomarker Analysis|Correlative studies
12005390|NCT00551070|Other|Pharmacological Study|Correlative studies
12005391|NCT00551070|Drug|Selumetinib|Given PO
12005392|NCT00551070|Drug|Selumetinib Sulfate|Given PO
12005393|NCT00551057|Behavioral|Expression type|to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue
12005394|NCT00551044|Drug|Bicalutamide|Bicalutamide 150mg once daily, oral administration, for 12 months
12005395|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)|0.1 mL, Intradermal (ID)
12005396|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)|0.1 mL, Intradermal (ID)
12005397|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)|0.5 mL, Intramuscular (IM)
12005398|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (High-dose)|0.5 mL, Intramuscular (IM)
12005399|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)|0.5 mL, Intramuscular (IM)
12005400|NCT00551018|Drug|Vicriviroc|one 30 mg tablet QD
12005401|NCT00551018|Drug|emtricitabine and tenofovir disoproxil fumarate|one 200/300 combination tablet QD
12005402|NCT00551005|Drug|celecoxib|
12005403|NCT00551005|Drug|etoposide|
12005404|NCT00551005|Other|immunoenzyme technique|
12005405|NCT00551005|Other|laboratory biomarker analysis|
12005406|NCT00550992|Biological|anti-thymocyte globulin|
12005407|NCT00550992|Drug|asparaginase|
12005408|NCT00550992|Drug|busulfan|
12005409|NCT00550992|Drug|cyclophosphamide|
12005410|NCT00550992|Drug|cyclosporine|
12005411|NCT00550992|Drug|cytarabine|
12005412|NCT00550992|Drug|daunorubicin hydrochloride|
12005413|NCT00550992|Drug|etoposide|
12005414|NCT00550992|Drug|leucovorin calcium|
12005415|NCT00550992|Drug|melphalan|
12005416|NCT00550992|Drug|mercaptopurine|
12005417|NCT00550992|Drug|methotrexate|
12005418|NCT00550992|Drug|mitoxantrone hydrochloride|
12005419|NCT00550992|Drug|pegaspargase|
12005420|NCT00550992|Drug|prednisolone|
12005421|NCT00550992|Drug|prednisone|
12005422|NCT00550992|Drug|therapeutic hydrocortisone|
12005423|NCT00550992|Drug|thioguanine|
12005424|NCT00550992|Drug|vincristine sulfate|
12005425|NCT00550992|Procedure|allogeneic bone marrow transplantation|
12005426|NCT00550992|Procedure|allogeneic hematopoietic stem cell transplantation|
12005427|NCT00550992|Procedure|umbilical cord blood transplantation|
12005428|NCT00550966|Behavioral|Psychoeducative program in fibromyalgic patients|Multi-component program including information about the illness, counselling about physical exercise and training in autogenic relaxation. The intervention consists on nine 2 hour sessions delivered during a two month period. The pharmacological treatment prescribed by the physician is maintained in both groups.
12005429|NCT00550953|Drug|telmisartan+amlodipine|
12005430|NCT00550953|Drug|telmisartan|
12005431|NCT00550927|Biological|bevacizumab|
12005432|NCT00550927|Drug|enzastaurin hydrochloride|
12005433|NCT00550927|Other|diagnostic laboratory biomarker analysis|
12005434|NCT00550927|Other|pharmacological study|
12005435|NCT00550901|Drug|cisplatin|
12005436|NCT00550901|Drug|dexrazoxane hydrochloride|
12005437|NCT00550901|Other|high performance liquid chromatography|
12005438|NCT00550901|Other|laboratory biomarker analysis|
12005439|NCT00550901|Other|mass spectrometry|
12005440|NCT00550901|Other|pharmacological study|
12005441|NCT00550888|Procedure|suture techniques|
12005442|NCT00550875|Biological|Grass pollen allergenic extract (L. perenne-C. dactylon )|Sublingual. 2 drops/daily 1000 DPP/ml 2 years
12005443|NCT00550875|Biological|Grass pollen allergenic extract (L. perenne-C. dactylon )|Sublingual. 2 drops/daily 10000 DPP/ml 2 years
12005444|NCT00550875|Biological|placebo|Sublingual. 2 drops/daily 2 years
12005445|NCT00550862|Drug|INT-747|Once a day (QD) by mouth (PO)
12005446|NCT00550862|Drug|Ursodeoxycholic Acid (URSO)|Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
12005447|NCT00550862|Drug|Placebo|Placebo
12005448|NCT00550849|Drug|RTA 402|5 mg oral capsules
12005449|NCT00550849|Drug|RTA 402|25 mg oral capsules
12005450|NCT00550849|Drug|RTA 402|50 mg oral capsules
12005451|NCT00550836|Biological|panitumumab|Given IV
12005452|NCT00550836|Drug|erlotinib hydrochloride|Given orally
12005453|NCT00550836|Drug|gemcitabine hydrochloride|Given IV
12005454|NCT00550823|Device|Cardiac CT 0BRILLIANT 64|Cardiac CT
12005455|NCT00550810|Drug|Sunitinib (SU011248)|SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression
12005456|NCT00550797|Biological|TPI ASM8|Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
12005457|NCT00550797|Biological|placebo|Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
12005458|NCT00550784|Biological|filgrastim|
12005459|NCT00550784|Drug|cisplatin|
12005460|NCT00550784|Drug|cyclophosphamide|
12005461|NCT00550784|Drug|melphalan|
12005462|NCT00550784|Drug|paclitaxel|
12005463|NCT00550784|Drug|topotecan hydrochloride|
12005464|NCT00550784|Genetic|TdT-mediated dUTP nick end labeling assay|
12005465|NCT00550784|Genetic|gene expression analysis|
12005466|NCT00550784|Other|immunohistochemistry staining method|
12005467|NCT00550784|Other|pharmacological study|
12005468|NCT00550784|Procedure|peripheral blood stem cell transplantation|
12005469|NCT00550771|Drug|doxorubicin, cyclophosphamide, paclitaxel, trastuzumab|doxorubicin 60 mg/m^2 IV push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
12005470|NCT00550771|Drug|PLD, cyclophosphamide, trastuzumab, paclitaxel|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
12005471|NCT00550758|Drug|Methachoine|inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine)
12005472|NCT00550758|Device|spirometry|spirometry
12005473|NCT00550745|Biological|Zoster Vaccine, Live|single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.
12005474|NCT00550745|Biological|Comparator: placebo|single 0.65 mL Placebo injection. 6 month treatment period.
12005475|NCT00550732|Drug|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
12005476|NCT00550693|Device|Chlorhexidine-impregnated foam dressing|Patients during the intervention period had this foam dressing applied around their central venous catheter. This was replaced once a week as recommended by the package insert unless the dressing was soiled, bloody, or fell off.
12005477|NCT00550680|Drug|Methoxy polyethylene glycol-epoetin beta|Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
12005478|NCT00550654|Other|questionnaire administration|Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.
12005479|NCT00550654|Radiation|3-dimensional conformal radiation therapy|Conformal radiation therapy improves the ability to spare normal tissues.
12005480|NCT00550654|Radiation|hypofractionated radiation therapy|Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.
12005481|NCT00550654|Radiation|image-guided radiation therapy|Image guided radiation therapy targets the specific site of disease.
12005482|NCT00550654|Radiation|tomotherapy|Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.
12005483|NCT00550641|Other|physical therapy|physical therapy in warm pool performing stretching
12005484|NCT00550641|Other|physical therapy|physical therapy in warm pool performing Ai Chi
12005485|NCT00550628|Genetic|DNA methylation analysis|
12005486|NCT00550628|Genetic|fluorescence in situ hybridization|
12005489|NCT00550628|Genetic|protein expression analysis|
12005490|NCT00550628|Genetic|reverse transcriptase-polymerase chain reaction|
12005491|NCT00550628|Other|diagnostic laboratory biomarker analysis|
12005492|NCT00550628|Other|immunoenzyme technique|
12005493|NCT00550628|Other|immunohistochemistry staining method|
12005494|NCT00550628|Procedure|biopsy|
12005495|NCT00550628|Procedure|therapeutic conventional surgery|
12005496|NCT00550628|Radiation|fludeoxyglucose F 18|
12005497|NCT00550615|Drug|Dasatinib|"Dasatinib will be orally administered once daily for 28 day cycles.
~There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts:
~Dose cohort # 1 will be 100 mg per day Dose cohort # 2 will be 150 mg per day Dose cohort # 3 will be 200 mg per day
~The MTD will be determined in the Phase I portion of this trial."
12005498|NCT00550615|Drug|Dasatinib Maximum Tolerated Dose|An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I.
12005499|NCT00550589|Drug|cidofovir|1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.
12005500|NCT00550589|Genetic|DNA methylation analysis|formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation
12005501|NCT00550589|Genetic|gene expression analysis|punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
12005502|NCT00550589|Genetic|polymerase chain reaction|performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
12005503|NCT00550589|Procedure|biopsy|punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
12005504|NCT00550589|Procedure|histopathologic examination|Evaluated at baseline and 6 weeks after treatment discontinuation
12005505|NCT00550576|Drug|Digibind (Fab)|Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.
12005506|NCT00550563|Dietary Supplement|cholecalciferol|Oral
12005507|NCT00550563|Genetic|polymerase chain reaction|companion study
12005508|NCT00550563|Genetic|polymorphism analysis|companion study
12005509|NCT00550563|Genetic|protein expression analysis|companion study
12005510|NCT00550563|Genetic|reverse transcriptase-polymerase chain reaction|companion study
12005511|NCT00550563|Genetic|western blotting|companion study
12005512|NCT00550563|Other|high performance liquid chromatography|companion study
12005513|NCT00550563|Other|laboratory biomarker analysis|companion study
12005514|NCT00550563|Other|pharmacological study|companion study
12005515|NCT00550563|Procedure|adjuvant therapy|Additional therapy
12005516|NCT00550563|Procedure|immunoscintigraphy|additional testing
12005517|NCT00550550|Drug|Placebo|Placebo sublingual tablet, once daily
12005518|NCT00550550|Biological|SCH 697243|Grass sublingual tablet, once daily
12005519|NCT00550550|Drug|Loratadine Syrup 1 mg/mL Rescue Treatment|Loratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to <6 years of age and at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.
12005520|NCT00550550|Drug|Loratadine 10 mg Rescue Treatment|Loratadine 10 mg RediTabs tablets were dosed orally once daily at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.
12005521|NCT00550550|Drug|Olopatadine 0.1% Rescue Treatment|Olopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication for participants with persistent eye symptoms due to rhinoconjunctivitis.
12005522|NCT00550550|Drug|Mometasone furoate 50 mcg Rescue Treatment|Mometasone furoate monohydrate nasal spray 50 mcg was dosed intranasally at a dose of one spray in each nostril once daily for participants aged 5 to <12 years and a dose of 2 sprays in each nostril once daily for participants aged 12 to <18 years as rescue medication for nasal symptoms of rhinoconjunctivitis among participants with a total symptom score of ≥4 despite loratadine and mometasone furoate nasal spray.
12005523|NCT00550550|Drug|Albuterol 108 mcg Rescue Treatment|Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administered via inhalation at a dose of 2 inhalations every 4 to 6 hours as rescue medication among participants aged 5 to <18 years with asthma symptoms .
12005524|NCT00550550|Drug|Fluticasone 44 mcg Rescue Treatment|Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to <18 years up to a maximum dose of 10 inhalations twice daily, in combination with albuterol, among participants with ≥4 albuterol sulfate inhalations/day for 2 days as rescue medication for nocturnal asthma or shortness of breath.
12005525|NCT00550550|Drug|Prednisone 5 mg Rescue Treatment|Prednisone tablet 5 mg was administered orally at a dose of 1 mg/kg/day once daily up to a maximum of 50 mg/day on Day 1, and at a dose of 0.5 mg/kg/day once daily up to a maximum of 25 mg/day on Days 2, 3, 5, and 7 as rescue medication for asthma exacerbation at the discretion of the investigator.
12005526|NCT00550537|Drug|bevacizumab|15 mg/m2 given through a vein for every 3 weeks
12005527|NCT00550537|Drug|carboplatin|AUC = 6 given through a vein on day 1 of each cycle.
12005528|NCT00550537|Drug|erlotinib hydrochloride|150 mg taken by mouth daily
12005529|NCT00550537|Drug|paclitaxel|200 mg/m2 given through a vein on day 1 of each cycle.
12005530|NCT00550537|Genetic|gene expression analysis|Blood and tissue collection.
12005531|NCT00550537|Genetic|protein expression analysis|Blood and tissue collection.
12005532|NCT00550537|Genetic|proteomic profiling|Blood and tissue collection.
12005533|NCT00550537|Other|laboratory biomarker analysis|Blood and tissue collection.
12005570|NCT00550225|Drug|GSK961081|GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
12005572|NCT00550212|Drug|neratinib|HKI-272, Single-dose capsule and solution
12005534|NCT00550524|Biological|Autologous Stem Cell Transplantation|Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 20-25 million cells; in a maximum volume of 4-6 ml. Cells will be injected in the knee joint with a 21 gauge needle.
12005535|NCT00550511|Radiation|Surgeon-performed ultrasound|After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.
12005536|NCT00550498|Biological|Autologous Stem Cell Transplantation|Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 3-5 million cells, in a maximum volume of 0.3 ml. Cells will be injected in vitreal at 3.5 millimeter of limbus with a 26 gauge insulin needle.
12005537|NCT00550485|Drug|escitalopram|escitalopram 4 mg
12005538|NCT00550472|Dietary Supplement|probiotics|Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420
12005539|NCT00550459|Drug|Tolvaptan|15-60 mg oral tablet given once a day for 21 days.
12005540|NCT00550459|Drug|Placebo|Placebo tablet given once daily for 21 days
12005541|NCT00550446|Drug|Adalimumab|40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
12005542|NCT00550446|Drug|CP-690-550|15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
12005543|NCT00550446|Drug|CP-690-550|10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
12005544|NCT00550446|Drug|CP-690-550|5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
12005545|NCT00550446|Drug|CP-690,550|3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
12005546|NCT00550446|Drug|CP-690,550|1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
12005547|NCT00550446|Drug|Placebo|Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
12005548|NCT00550433|Device|Bazedoxifene/Conjugated Estrogens|
12005549|NCT00550420|Drug|Rosiglitazone XR|experimental drug
12005550|NCT00550407|Drug|lamotrigine|lamotrigine 100mg/day or 200mg/day
12005551|NCT00550407|Drug|Placebo|placebo once daily
12005552|NCT00550394|Drug|quetiapine and placebo|"Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
~Dosing Schedule and Titration of Topiramate:
~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
12005553|NCT00550394|Drug|Quetiapine and Topiramate|"Dosing Schedule and Titration of Quetiapine:
~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
~Dosing Schedule and Titration of Topiramate:
~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
12005554|NCT00550381|Drug|HKI-357|Single-dose capsule
12005555|NCT00550368|Biological|Biological intervention: Enteropathogenic E. coli|5x10^8 or 1x10^9 organisms of EPEC were administered to all participants.
12005556|NCT00550355|Drug|PD 0360324|3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
12005557|NCT00550355|Drug|PD 0360324|3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
12005558|NCT00550355|Drug|PD 0360324|3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
12005559|NCT00550355|Drug|Placebo|3 doses of Placebo administered over 12 weeks
12005560|NCT00550342|Drug|rituximab|375 mg/m2 intravenously for 4 doses
12005561|NCT00550329|Drug|Glipizide GITS|
12005562|NCT00550303|Drug|bazedoxifene/conjugated estrogens combination|
12005563|NCT00550290|Drug|Cefazolin PostOperatively|Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used.
12005564|NCT00550290|Drug|Cefazolin Preoperatively|Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.
12005565|NCT00550277|Drug|LBH589|LBHLBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring (Section 3.5.2), all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles.
12005566|NCT00550264|Other|Automatic notification of readmissions|The experimental group physicians will receive automatic e-mail notification when a patient is readmitted, including contact information for the readmitting team.
12005567|NCT00550251|Device|Acupressure Wrist Bands (Sea-Bands)|Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
12005568|NCT00550251|Device|Placebo wristbands|Elasticated wrist bands without active bead.
12005569|NCT00550238|Drug|Pimavanserin tartrate (ACP-103)|Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
12005571|NCT00550225|Drug|GSK961081 matching placebo|GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
12005664|NCT00549497|Drug|GW870086X|
12005573|NCT00550199|Drug|LBH589, Gemcitabine|Phase I dose escalation: LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days.
12005574|NCT00550186|Other|placebo|
12005575|NCT00550186|Drug|Ringers Lactate|
12005576|NCT00550186|Drug|HaemoHES 6%|
12005577|NCT00550173|Drug|pemetrexed|500 milligrams per meter squared (mg/m^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops
12005578|NCT00550173|Drug|erlotinib|150 mg, orally, once daily until progression or unacceptable toxicity develops
12005579|NCT00550160|Drug|Amodiaquine plus Artesunate co-administration|"Under the Home Management of Malaria (HMM) strategy the Community Drug Distributors (CDD) will treat all children under 5 years presented to them with measured fever or a history of fever with AQ plus AS co-administered. Children under 12 months receive 75mg of AQ co-administered with 25mg of AS daily for three days. Children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days.
~Asymptomatic children under 5 years in the Intermittent Preventive Treatment (IPTc) clusters will receive additional AQ plus AS co-administered during high malaria transmission season. Those under 12 months will receive 75mg of AQ co-administered with 25mg of AS daily for three days; and children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days."
12005580|NCT00550147|Drug|Oros Methylphenidate|"Oros methylphenidate will be titrated over 3 visits according to the following schedule:
~Visit 2 dose of 18 mg QAM
~Visit 3 dose of 36mg QAM
~Visit 4 dose of 54mg QAM."
12005581|NCT00550147|Drug|quetiapine|"Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1).
~Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg)
~Visit 5 dose of 25mg BID
~Visit 6 dose of 50mg BID
~Visit 7 dose of 100mg BID
~Visit 8 dose of 200mg BID
~Visit 9 dose of 300mg BID
~Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule."
12005582|NCT00550134|Behavioral|Questionnaires, MRI, Comet assay and Cell senescence|Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
12005583|NCT00550134|Behavioral|Questionnaires, MRI, Comet assay and Cell senescence|Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
12005584|NCT00550134|Behavioral|Questionnaires, MRI, Comet assay and Cell senescence|Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence
12005585|NCT00550121|Drug|vitamin C|
12005586|NCT00550121|Drug|placebo|
12005587|NCT00550108|Other|Ethanol lavage|Ethanol lavage of pancreatic cysts.
12005588|NCT00550095|Drug|valsartan|
12005589|NCT00550056|Behavioral|Narrative Exposure Therapy|Six session of Narrative Exposure Therapy
12005590|NCT00550056|Behavioral|Trauma Counselling|Six sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist
12005591|NCT00550043|Drug|INCB018424|
12005592|NCT00550043|Drug|Placebo|
12005593|NCT00550030|Radiation|UVB-311nm radiation|UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.
12005594|NCT00550030|Other|No treatment|no UV exposure
12005595|NCT00550017|Drug|Epofolate|Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1 through 4 of a 21-day cycle, until the disease progresses
12005596|NCT00550004|Drug|RP101|190 mg oral tablet
12005597|NCT00550004|Drug|Gemcitabine (1000 mg/m2)|30 minute intravenous infusion
12005598|NCT00549978|Drug|Cilostazol|cilostazol, then cilostazol/probucol
12005599|NCT00549978|Drug|Probucol|Probucol probucol/ cilostazol
12005600|NCT00549965|Drug|Risedronate Sodium|
12005601|NCT00549952|Other|no intervention study|
12005602|NCT00549939|Drug|Alfuzosin|"Form: solution or tablet according to age
~Route: oral
~Dose: daily dose adjusted to body weight"
12005603|NCT00549939|Drug|Placebo|"Form: matching solution or matching tablet according to age
~Route: oral
~Dose: daily dose adjusted to body weight"
12005604|NCT00549926|Drug|Fluvastatin|
12005605|NCT00549926|Drug|Pravastatin|
12005606|NCT00549926|Drug|Pitavastatin|
12005607|NCT00549926|Drug|Atorvastatin|
12005608|NCT00549913|Biological|NeoFuse|immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Resorbable Ceramic Granules in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
12005609|NCT00549913|Procedure|posterolateral spinal fusion with instrumentation|autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
12005610|NCT00549900|Biological|GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)|Intramuscular injection, 3 doses
12005611|NCT00549887|Drug|Analog or Human Insulin|prescribed in accordance with usual clinical practice
12005612|NCT00549874|Drug|Rosiglitazone|oral 8 mg/once daily for 6 months
12005613|NCT00549874|Drug|Glyburide|20 mg/ once daily for 6 months
12005614|NCT00549861|Procedure|Cardiac Magnetic Resonance study|Cardiac MRI study
12005615|NCT00549848|Drug|Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine|See Detailed Description section for details of treatment interventions.
12005616|NCT00549848|Drug|Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib|See Detailed Description section for details of treatment interventions.
12005617|NCT00549835|Procedure|Real Acupuncture|
12005665|NCT00549471|Other|physiotherapy|CG children will undergo a program of intensive physiotherapy
12005666|NCT00549471|Other|Botulinum Toxin A and physiotherapy|BG children will be given Botox, as clinically required, in addition to an equivalent program of intensive therapy. Botox injection will be tailored according to the specific child. Generally injection site will include biceps and brachioradialis, while flexors of the wrist and digits will be injected according to abnormal postures during function. Maximal total dose will be 23 IU per kg.
12005763|NCT00548678|Drug|aspirin|oral aspirin
12005764|NCT00548665|Device|Carotid ultrasound for plaque screening|Carotid ultrasound for plaque screening
12005618|NCT00549835|Procedure|Sham Acupuncture|"Sham needles are developed to exclude sham effect and to prove real acupuncture efficacy. We will use specifically retractable Park Sham Device (AcuPrime, Exeter, UK) for control group. Because this sham device gives the impression of insertion with telescopic needle body and some pricking sensation with a bunt needle tip. It is a valid control for many acupuncture trials as it doesn't penetrate skin and doesn't create active stimulation as much as real needles or acupressure. To avoid unnecessary stimulation of penetrating skin in this population, we plan to use non-penetrating sham device rather than penetrating non-acupuncture point with real needles as control intervention.
~All other procedures will be same as Real Acupuncture group except using non-penetrating sham needles on non-acupuncture points. After final session, we will ask all subjects in both groups which form of treatment each subject believe to have during study and will analyze blinding credibility."
12005619|NCT00549822|Drug|Letrozole|Treatment is intermittent with possible breaks between each 28 day treatment cycle if CA 15-3 or CA 27.29 level that has decreased by at least 50% of that individual patient's baseline or peak level on firstline letrozole or anastrozole therapy or has decreased into the normal reference range per institutional parameters. Letrozole or anastrozole therapy will be interrupted until CA 15-3 or CA 27.29 levels rise by at least 25% above trough CA 15-3 or CA 27.29 level. If the trough level is in the normal reference range then the CA 15-3 or CA 27.29 must rise into the normal reference range.
12005620|NCT00549809|Procedure|Intermittent mandatory ventilation (IMV) and synchronous IMV|Patients divided to receive two different modes of mechanical ventilation.
12005621|NCT00549796|Other|Percutaneous coronary intervention (PCI)|Patients undergo routine, clinically indicated PCI
12005622|NCT00549783|Biological|Botulinum Toxin Type A 900kD|"The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
~First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit."
12005623|NCT00549783|Biological|Placebo|"The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
~First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit."
12005624|NCT00549770|Drug|LCZ696|
12005625|NCT00549770|Drug|Valsartan|
12005626|NCT00549770|Drug|AHU377|
12005627|NCT00549770|Drug|Placebo|
12005628|NCT00549757|Drug|Aliskiren|Aliskiren 150 mg film-coated tablets
12005629|NCT00549757|Drug|Placebo|Placebo to match aliskiren 150 mg film-coated tablets
12005630|NCT00549744|Drug|GSK256066|
12005631|NCT00549718|Drug|Lurasidone HCl|Once daily
12005632|NCT00549692|Drug|Omega-3 fatty acid ethylester90|Dosage form :1g soft capsule Dosage : two capsules, twice a day.
12005633|NCT00549679|Drug|GSK256066|PDE4 inhibitor
12005634|NCT00549679|Drug|Placebo|Placebo
12005635|NCT00549666|Drug|Lurasidone 40 mg|Lurasidone 40 mg days 12-21 once daily
12005636|NCT00549666|Drug|Placebo 40 mg|Placebo 40 mg once daily during treatment period
12005637|NCT00549666|Drug|Ortho Tri-Cyclen|Ortho Tri-Cyclen during 28-day lead in period
12005638|NCT00549653|Drug|GW856553|
12005639|NCT00549640|Drug|Methylphenidate|54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day).
12005640|NCT00549640|Drug|Placebo|non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg)
12005641|NCT00549627|Device|Pediguard|PediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions.
12005642|NCT00549614|Drug|acipimox|capsule, 250 mg, 4 times daily for 28 days
12005643|NCT00549614|Drug|placebo|capsule, 250 mg, 4 times daily for 28 days
12005644|NCT00549601|Drug|Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
12005645|NCT00549601|Drug|Rivastigmine patch (9.5 mg/day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
12005646|NCT00549601|Drug|Rivastigmine capsules (6 mg to 12 mg/day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
12005647|NCT00549588|Other|After-sun-lotion with DNA repair enzymes|2 mg/cm2 immediately after UV exposure
12005648|NCT00549588|Other|SPF30 sunscreen|2 mg/cm2 2o min before UV exposure
12005649|NCT00549588|Other|Placebo after-sun-lotion|2mg/cm2 immediately after UV exposure
12005650|NCT00549588|Other|Intervention: none (only UV)|
12005651|NCT00549575|Drug|L ARG|Patients received 14 g/day of L-arginine (90 mL syrup, Veyron France Laboratories).
12005652|NCT00549575|Drug|Placebo|After double blind randomization, patients received a placebo.
12005653|NCT00549562|Drug|Paliperidone ER|Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
12005654|NCT00549549|Drug|Indomethacin|indomethacin 50 mg three times a day (TID) for 8 days.
12005655|NCT00549549|Drug|Celecoxib|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.
12005656|NCT00549549|Drug|Celecoxib|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.
12005657|NCT00549549|Drug|Celecoxib|Celecoxib 50 mg two times a day (BID) for 8 days
12005658|NCT00549536|Dietary Supplement|tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)|1500 mg of elemental calcium per day.
12005659|NCT00549523|Drug|Placebo|Capsules containing 0 mg bid (placebo)
12005660|NCT00549523|Drug|Low Dose|Capsules containing 400 mg bid of L. frutescens.
12005661|NCT00549523|Drug|Mid Dose|Capsules containing 800 mg bid of L. frutescens.
12005662|NCT00549523|Drug|High Dose|Capsules containing 1200 mg bid of L. frutescens.
12005663|NCT00549510|Drug|COREG CR and lisinopril (FDC)|
12005667|NCT00549458|Behavioral|Pilates|The currently popular exercise program, known as Pilates (named after founder, Joseph Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The philosophy centers around developing core strength which includes strengthening the pelvic floor. Its use has been described in the US since the 1920s.4 Five million Americans currently participate, as opposed to five thousand ten years ago.5 Given its mainstream popularity, Pilates would be an appealing as a therapeutic modality for women experiencing pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates in increasing pelvic muscle strength.
12005668|NCT00549458|Procedure|Pelvic muscle rehabilitation therapy|The currently popular exercise program, known as Pilates (named after founder, Joseph Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The philosophy centers around developing core strength which includes strengthening the pelvic floor. Its use has been described in the US since the 1920s.4 Five million Americans currently participate, as opposed to five thousand ten years ago.5 Given its mainstream popularity, Pilates would be an appealing as a therapeutic modality for women experiencing pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates in increasing pelvic muscle strength.
12005669|NCT00549445|Drug|Azithromycin|250 mg daily
12005670|NCT00549445|Drug|Placebo|Daily
12005671|NCT00549432|Device|TALENT Enhanced LPS Endoluminal Stent-Graft System|roadmapping, and angiography for proper implant positioning. The TALENT endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
12005672|NCT00549419|Drug|Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine|The Control group will be assessed using the standard care of traditional vital signs
12005673|NCT00549419|Drug|Goal-directed hemodynamic therapy|Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
12005674|NCT00549419|Drug|Standard of care|Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
12005675|NCT00549406|Procedure|computerized visual training|two one-hour training sessions per week, for five consecutive weeks
12005676|NCT00549406|Procedure|computerized word puzzles|two one-hour sessions per week, for five consecutive weeks
12005677|NCT00549406|Procedure|video-game based visual training|two one-hour training sessions per week, for five consecutive weeks
12005678|NCT00549393|Drug|2% Chlorhexidine gluconate cloth|Daily bathing
12005679|NCT00549380|Device|Endologix, Inc. Endoluminal Technology|Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
12005680|NCT00549367|Behavioral|Nutrition Counselling|Clients will receive ongoing nutrition assessment and dietary counselling. The intervention arm will receive all baseline assessments and individual nutritional assessment, counselling and nutrition management plans using standards of practice
12005681|NCT00549354|Device|Endoluminal Graft|
12005682|NCT00549341|Drug|Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin|100U vials, doses ranged from 50U-200U, single injection.
12005683|NCT00549341|Other|Physiologic saline|Single injection.
12005684|NCT00549328|Drug|Pazopanib (GW786034)|Pazopanib monotherapy
12005685|NCT00549315|Device|Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter|VALIANT stent-graft endoprosthesis is inserted by the Xcelerant Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
12005686|NCT00549302|Drug|tadalafil|20 milligram (mg) tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of Pulmonary Arterial Hypertension (PAH).
12005687|NCT00549302|Drug|tadalafil|40 mg tablet taken by mouth once a day for 52 weeks in phase 1. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of PAH.
12005688|NCT00549289|Drug|cyclosporine A|
12005689|NCT00549263|Drug|SB797620|
12005690|NCT00549237|Dietary Supplement|Glucose load (Nutricia)|Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
12005691|NCT00549237|Other|Post operative early enteral feeding|Enteral feeding starting 6 hours post surgery
12005692|NCT00549211|Drug|GSK557296|
12005693|NCT00549198|Drug|Abacavir/lamivudine and efavirenz|
12005694|NCT00549198|Drug|Tenofovir/Emtricitabine and efavirenz|
12005695|NCT00549185|Drug|SAR3419|Intravenous infusion
12005696|NCT00549172|Procedure|Operative (partial arthroscopy)|Partial arthroscopic resection of degenerative rupture of the medial meniscus
12005697|NCT00549172|Procedure|Conservative (diagnostic arthroscopy)|Diagnostic arthroscopy
12005698|NCT00549159|Device|Thermal Balloon Endometrial Ablation|Thermal balloon endometrial ablation
12005699|NCT00549159|Device|Transcervical Resection of the Endometrium|Transcervical resection of the endometrium
12005700|NCT00549146|Drug|fluticasone propionate/salmeterol 250/50 DISKUS combination product|
12005701|NCT00549146|Drug|fluticasone propionate DISKUS 500mcg|
12005702|NCT00549133|Drug|Irbesartan|
12005703|NCT00549120|Drug|Propranolol|40 mg tablets
12005704|NCT00549120|Drug|Salbutamol|Metered dose inhaler (600 μg)
12005705|NCT00549120|Drug|Ipratropium|Metered dose inhaler (40 μg)
12005706|NCT00549120|Drug|Placebo|Placebo for propranolol tablets
12005707|NCT00549107|Drug|Levosimendan|
12005708|NCT00549107|Drug|Milrinone|
12005709|NCT00549081|Dietary Supplement|DHEA|oral DHEA tablets 75 mg daily
12005710|NCT00549068|Drug|Risedronate Sodium (Actonel)|
12005711|NCT00549055|Drug|Macugen|Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)
12005712|NCT00549042|Drug|OROS hydromorphone|hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
12005713|NCT00549042|Drug|Placebo|Placebo
12005714|NCT00549029|Genetic|DNA|withdraw 5~10mL blood from vein only once during the whole design
12005715|NCT00549016|Device|PTPE Encapsulation of Nitinol Stents|Both common femoral arteries (CFAs) are surgically exposed to allow bilateral access of diagnostic and therapeutic devices. The endoluminal stent graft is then deployed in accordance with the Instructions for Use.
12005716|NCT00549003|Device|Rapid Diagnostic Test for P. falciparum malaria|
12005717|NCT00548990|Behavioral|cardiovascular exercise training|
12005718|NCT00548990|Behavioral|flexibility/balance control|
12005719|NCT00548977|Other|Drawing blood to study genetic polymorphism|
12005720|NCT00548964|Drug|Lithium|600-900mg of Li carbonate
12005721|NCT00548964|Drug|Ketamine|0.5mg/kg of ketamine
12005722|NCT00548951|Other|Snoezelen Room|Session in a Snoezelen room once per week for 12 weeks
12005723|NCT00548951|Other|Snoezelen Room|Session in a Snoezelen room three times per week for 12 weeks
12005724|NCT00548951|Other|Control|Receive no sessions in a Snoezelen Room.
12005725|NCT00548938|Drug|Gliadel wafer|Implanted at surgery
12005726|NCT00548938|Drug|Temozolomide|During External Beam Radiation
12005727|NCT00548938|Radiation|External Beam Radiation Therapy|60 Gy
12005728|NCT00548925|Drug|ABT-894|6 mg BID tablets, 8 weeks of treatment
12005729|NCT00548925|Drug|placebo|BID tablets, 8 weeks of treatment
12005730|NCT00548912|Drug|Spironolactone|
12005731|NCT00548899|Drug|Nexavar (Sorafenib)|Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day
12005732|NCT00548886|Drug|Epinephrine|We will follow the protocol outlined by Ackerman et al. known as the Mayo protocol4 which is currently used routinely in our electrophysiology laboratory. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes and a twelve-lead electrocardiogram is obtained at time=0 minutes, 5 minutes, and 10 minutes. The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes and the electrocardiogram repeated. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes and electrocardiogram obtained. The epinephrine infusion is then discontinued and measurements are obtained at five minutes and ten minutes after stopping the epinephrine infusion. The total time of procedure will be 35 minutes.
12005733|NCT00548860|Drug|Ferric Carboxymaltose|
12005734|NCT00548860|Drug|Standard Medical Care (SMC)|
12005735|NCT00548847|Biological|GM-CSF|Dosing schedule: 250 mcg/m² subcutaneously Mon-Wed-Fri. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
12005736|NCT00548847|Biological|Interferon-α-2b|Dosing schedule: 1.5 mcg/kg subcutaneously Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
12005737|NCT00548834|Drug|CDP870|
12005738|NCT00548821|Drug|Cisplatin|
12005739|NCT00548808|Drug|Insulin lispro low mixture|Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
12005740|NCT00548808|Drug|Insulin glargine|Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
12005741|NCT00548808|Drug|Insulin lispro|Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
12005742|NCT00548782|Other|Paleolithic diet|diet
12005743|NCT00548782|Other|ADA ( American Diabetes Association) recommended diet|diet
12005744|NCT00548769|Drug|Formulation A|Formulation A will contain firategrast drug substance from native drug batch Irvine. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.1 square meter per gram. The tablets will be administered with 240 milliliters of water.
12005745|NCT00548769|Drug|Formulation B|Formulation B will contain firategrast drug substance from native drug batch Tonbridge. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
12005746|NCT00548769|Drug|Formulation C|Formulation C will contain firategrast drug substance from Tonbridge single pass micronized drug. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 3-4 square meter per gram. The tablets will be administered with 240 milliliters of water.
12005747|NCT00548769|Drug|Formulation D|Formulation D will contain firategrast drug substance from Tonbridge with reduced tablet size. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
12005748|NCT00548756|Procedure|Whole Brain Radiation Therapy|Whole Brain Radiation Therapy. Total dose = 30 Gy over 12 fractions at 2.5Gy per fraction.
12005749|NCT00548756|Other|Observation|Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions.
12005750|NCT00548756|Behavioral|Questionnaire|Questionnaire taking 40 minutes to complete.
12005751|NCT00548743|Behavioral|Screening and follow up|Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits
12005752|NCT00548743|Behavioral|Usual care|usual care for identification and management of postpartum depression
12005753|NCT00548730|Procedure|Bronchoscopy|The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope and the flexible white light video-bronchoscope. Biopsies are taken of a normal region and all abnormal regions.
12005754|NCT00548717|Drug|Sirolimus|
12005755|NCT00548717|Drug|Mycophenolate mofetil|
12005756|NCT00548717|Drug|Bortezomib|
12005757|NCT00548704|Drug|Dexrazoxane|
12005758|NCT00548691|Drug|Ferric Carboxymaltose|
12005759|NCT00548691|Drug|Standard Medical Care (SMC)|
12005760|NCT00548678|Drug|intravenous diclofenac sodium (DIC075V)|intravenous diclofenac sodium
12005761|NCT00548678|Drug|ketorolac|intravenous ketorolac
12005762|NCT00548678|Drug|oral diclofenac (Cataflam)|oral diclofenac (Cataflam)
12005765|NCT00548665|Behavioral|Brief advice for smoking cessation|We will use the 5A's heuristic (Ask about smoking, Advise on cessation, Assess willingness to change, and for those willing to make quit attempt: Assist with attempt to quit, and Arrange for follow-up) and the gold standard for brief smoking cessation advice. At each visit, smokers will receive smoking cessation counseling and nicotine replacement therapy, similar to the experimental group.
12005766|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
12005767|NCT00548652|Behavioral|medical crisis councelling|group counselling sessions
12005768|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
12005769|NCT00548652|Drug|methyphenidate|methyphenidate will be used to treat apathy dose 10mg bid
12005770|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
12005771|NCT00548652|Drug|methyphenidate|methyphenidate will be used to treat apathy dose 10mg bid
12005772|NCT00548652|Behavioral|medical crisis councelling|group counselling sessions
12005773|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
12005774|NCT00548639|Other|Statin Choice Decision Aid|Paper based instrument with pictures indicating level of risk.
12005775|NCT00548639|Other|Control Pamphlet|ADA Diabetes Sheet
12005776|NCT00548626|Procedure|Single needle|Patients will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
12005777|NCT00548626|Procedure|Multiple needle|Patients will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
12005778|NCT00548613|Biological|MESENDO|Intracoronary transplantation of autologous stem cells via balloon catheter
12005779|NCT00548613|Biological|MESENDO|Intracardiac transplantation of autologous stem cells via direct injection
12005780|NCT00548600|Procedure|Iridium Implant|Temporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks.
12005781|NCT00548600|Radiation|Standard external beam irradiation|Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.
12005782|NCT00548587|Drug|E5555|
12005783|NCT00548587|Drug|Placebo|
12005784|NCT00548574|Drug|SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine|
12005785|NCT00548574|Drug|Mesalazine|
12005786|NCT00548561|Drug|Dexrazoxane|
12005787|NCT00548548|Drug|Bevacizumab|Intravenous bevacizumab 7.5 mg/kg once every 3 weeks, given until disease progression or unmanageable toxicity.
12005788|NCT00548548|Drug|Capecitabine|Oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, given until disease progression or unmanageable toxicity.
12005789|NCT00548548|Drug|Cisplatin|Cisplatin 80 mg/m˄2 as a 2 hr intravenous infusion with hyper-hydration and pre-medication (steroids and anti-emetics), given every 3 weeks for a maximum of 6 cycles or until disease progression or unmanageable toxicity.
12005790|NCT00548548|Drug|Placebo|Intravenous placebo every 3 weeks, given until disease progression or unmanageable toxicity.
12005791|NCT00548548|Drug|5-fluorouracil|For participants with difficulty swallowing, malabsorption, or other conditions that could affect intake of oral capecitabine medication, 5-fluorouracil was administered instead, at a dose of 800 mg/m˄2/day as a continuous intravenous infusion over 5 days (days 1 to 5 of each cycle), every 3 weeks.
12005792|NCT00548535|Procedure|Reliability of complication assessment|
12005793|NCT00548509|Drug|Menatetrenone (Vitamin K2)|
12005794|NCT00548496|Drug|SB-751689|SB-751689
12005795|NCT00548496|Other|Placebo|Placebo to match
12005796|NCT00548483|Drug|dexamethasone (Oradexon, Nederland)|dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2
12005797|NCT00548470|Drug|Varenicline|Varenicline 1-2 mg/day
12005798|NCT00548444|Biological|MVA85A|Vaccine. Dose: 1 x 10^8 plaque-forming units (pfu) given by intradermal injection into the deltoid region of the upper arm.
12005799|NCT00548444|Other|Deuterated glucose infusion|6,6D2-glucose given as a timed intravenous infusion. The total dose of deuterated glucose will be 1g/kg volunteer body weight (up to a maximum of 60g).
12005800|NCT00548431|Drug|6-mercaptopurine|Standard dose 25 mg/m^2/day. Can be increased up to 75 mg/m^2/day if the myelosuppression is acceptable (ANC>0.5 T-count >50)
12005801|NCT00548418|Drug|Topotecan|
12005802|NCT00548418|Drug|Cisplatin|
12005803|NCT00548418|Drug|Bevacizumab|
12005804|NCT00548405|Biological|Alemtuzumab 12 mg|Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
12005805|NCT00548405|Biological|Alemtuzumab 24 mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
12005806|NCT00548405|Biological|Interferon beta-1a|Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
12005807|NCT00548379|Drug|vitamin D|vitamin D 100,000 units once in 3 months
12005808|NCT00548379|Drug|placebo|olive oil 1ml
12005809|NCT00548366|Other|Sodium restriction|4 gram sodium diet
12005810|NCT00548366|Other|Sodium restriction|2 gram sodium diet
12005811|NCT00548353|Drug|MK3207|M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).
12005812|NCT00548353|Drug|Comparator: Placebo (unspecified)|M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).
12005813|NCT00548340|Drug|VEC-162 20 mg|20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
12005814|NCT00548340|Drug|Placebo|Placebo capsules, PO daily for five weeks
12005815|NCT00548340|Drug|VEC-162 50 mg|50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
12005816|NCT00548327|Drug|Atomoxetine|Comparison between Atomoxetine and Placebo
12005817|NCT00548327|Procedure|Functional magnetic resonance imaging|Comparison between Atomoxetine and Placebo arms
12005818|NCT00548327|Procedure|Neuropsychological Testing|Comparison between Atomoxetine and Placebo arms
12005819|NCT00548327|Drug|Placebo|25 mg, 40 mg, 60 mg and 80 mg Atomoxetine Placebo
12005820|NCT00548314|Other|dermal matrix|1mm thickness matrix composed of collagen-elastin hydrolosate
12005821|NCT00548314|Procedure|Split skin graft|
12005822|NCT00548314|Device|VAC therapy (KCI)|VAC therapy for 3-5 days 125mmHg
12005823|NCT00548301|Drug|cyclosporine|
12005824|NCT00548288|Drug|pamidronate|
12005825|NCT00548275|Behavioral|Enhanced Sexual Risk Management|management of sexual risk
12005826|NCT00548275|Behavioral|Standard Sexual Risk Management|management of sexual risk
12005827|NCT00548262|Drug|Anidulafungin|All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.
12005828|NCT00548262|Drug|Voriconazole|Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if <40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if <40 kg body weight).
12005829|NCT00548249|Device|Standard Bicarbonate Solution|Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
12005830|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
12005831|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
12005832|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
12005833|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
12005834|NCT00548236|Behavioral|Telephone-Based exercise intervention|Exercise counselling offered via telephone calls
12005835|NCT00548223|Drug|Dengzhan Shengmai capsule|Capsule, 0.18g, 2#, Bid*1year
12005836|NCT00548223|Drug|placebo|Capsule, 0.18g, 2#, Bid*1year
12005837|NCT00548197|Drug|Bevacizumab|one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
12005838|NCT00548184|Drug|Lapatinib|Monoclonal Antibody
12005839|NCT00548184|Drug|Trastuzumab|Monoclonal Antibody
12005840|NCT00548184|Drug|Endocrine|Hormonal Therapy
12005841|NCT00548171|Biological|Boostrix™|Intramuscular injection, 1 dose
12005842|NCT00548145|Drug|Pitavastatin|2 mg by orally/day Duration: 12 months
12005843|NCT00548145|Drug|cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)|duration: 12 months
12005844|NCT00548132|Device|Chlorhexidine-impregnated foam dressing|Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.
12005845|NCT00548119|Biological|NeoCart|autologous tissue implant
12005846|NCT00548119|Procedure|microfracture|microfracture
12005847|NCT00548106|Dietary Supplement|partially hydrolyzed whey|Total infant feeding by study formula.
12005848|NCT00548106|Dietary Supplement|Nan HA|Total infant diet by study formula.
12005849|NCT00548093|Drug|PF-00299804|PF-00299804 orally at 45 mg daily, on continuous schedule
12005850|NCT00548093|Drug|PF-00299804|PF-00299804 orally at 45 mg daily, on continuous schedule
12005851|NCT00548080|Drug|MK0991, caspofungin acetate / Duration of Treatment:|
12005852|NCT00548067|Drug|Valsartan/hydrochlorothiazide (HCTZ)|
12005853|NCT00548067|Drug|Valsartan/amlodipine|
12005854|NCT00548067|Drug|Amlodipine/hydrochlorothiazide(HCTZ)|
12005855|NCT00548067|Drug|Valsartan/amlodipine/hydrochlorothiazide(HCTZ)|
12005856|NCT00548054|Biological|Bivalent killed oral cholera vaccine|Oral, 1.5 ml, given 2 times at least 14 days apart
12005857|NCT00548054|Biological|Killed Escherichia coli K12 placebo|oral, 1.5 ml per dose
12005858|NCT00548041|Other|HIV test by oral swab|Eligible subjects underwent rapid HIV testing by oral swab.
12005859|NCT00548015|Behavioral|state-of-the art strategy and extented strategy|state-of-the art: education, reminders, performance feedback, extented:state-of-the art and coaching ward manager,modeling of informal leaders, norm and target setting
12005860|NCT00548002|Drug|trovafloxacin and levofloxacin|Trovafloxacin: <60 kg 200 mg iv/orally once daily and >60 kg 300 mg iv/orally once daily Levofloxacin: < 60 kg 500 mg iv/orally once daily and >60 kg 500 mg iv/orally bid
12005861|NCT00547989|Drug|standard anaesthesia (bupivacaine)|Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
12005862|NCT00547989|Drug|additional pvb (ropivacaine) and elastomeric disposable infusion pump|Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.
12005863|NCT00547989|Drug|additional pvb (ropivacaine)|Patients in group 1 will receive PVB with ropivacaine
12005864|NCT00547976|Drug|[C-11]PBR28|
12005865|NCT00547963|Behavioral|brief counseling|baseline assessment + two 40 minute sessions of brief counseling
12005866|NCT00547950|Drug|:Deng Zhan Sheng Mai Capsule|capsule，0.18g，2＃，po，Bid*1year.
12005867|NCT00547937|Device|nasal continuous positive airway pressure (CPAP) therapy|Nocturnal ventilation through a nasal mask to avoid sleep apneas
12005868|NCT00547924|Behavioral|Transoesophageal echocardiography|Transoesophageal echocardiography in liver transplantation: left ventricular function during reperfusion
12005869|NCT00547911|Drug|Droxidopa|
12005870|NCT00547911|Drug|Carbidopa|
12005871|NCT00547911|Drug|Entacapone|
12005872|NCT00547898|Drug|Crofelemer 125 mg|Crofelemer 125 mg
12005873|NCT00547898|Drug|Crofelemer 250 mg|Crofelemer 250 mg
12005874|NCT00547898|Drug|Crofelemer 500 mg|Crofelemer 500 mg
12005875|NCT00547898|Drug|Placebo|Placebo
12005876|NCT00547885|Drug|Dihydrocodeine|"Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo short action
~Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo short action
~Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo short action
~Group 4: 2 placebo for long acting + up to 4*30 mg dihydrocodeine short acting
~Group 5: 3 placebo for long acting + up to 6*30 mg dihydrocodeine short acting
~Group 6: 3 placebo for long acting + up to 8*30 mg dihydrocodeine short acting"
12005877|NCT00547872|Procedure|exercise testing - coronary angiography - revascularization|Those patients with a positive exercise ECG test will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery
12005878|NCT00547846|Drug|PDC-748|
12005879|NCT00547820|Other|placebo|
12005880|NCT00547820|Device|Urinary sensor|
12005881|NCT00547807|Other|Non-nutritive sucking|Non-nutritive sucking is applied by using a gloved finger
12005882|NCT00547807|Other|Swaddling|Swaddling is an age-old practice of wrapping infants snugly in swaddling cloths, blankets or similar cloth so that movement of the limbs is tightly restricted
12005883|NCT00547781|Procedure|PGD|
12005884|NCT00547768|Drug|Fexofenadine HCI|
12005885|NCT00547742|Procedure|PET/CT Scan|
12005886|NCT00547742|Procedure|phlebotomy|
12005887|NCT00547729|Device|HeartPOD™ System|HeartPOD™ device automatically measures left heart pressures throughout the day.
12005888|NCT00547716|Dietary Supplement|Omega-3 Fatty Acids|Omega-3 Fatty Acids - 4 grams per day
12005889|NCT00547716|Drug|Placebo comparator|
12005890|NCT00547703|Drug|Nortriptyline|Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
12005891|NCT00547703|Drug|Placebo|An identical placebo capsule containing lactose, administered orally, every night for 8 weeks
12005892|NCT00547690|Other|Acupuncture and Strengthening|Acupuncture and strengthening
12005893|NCT00547690|Other|Strengthening Alone|Strengthening training program
12005894|NCT00547677|Radiation|stereotactic radiosurgery|
12005895|NCT00547664|Drug|Hylenex recombinant , morphine, saline|Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with or without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.
12005896|NCT00547664|Other|Saline|Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.
12005897|NCT00547651|Drug|Amrubicin|Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course
12005898|NCT00547651|Drug|Topotecan|Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course
12005899|NCT00547638|Device|cyanoacrylate with pressure sensitive mesh|Topical Skin Adhesive
12005900|NCT00547638|Device|cyanoacrylate|Topical Skin Adhesive
12005901|NCT00547625|Drug|tadalafil|Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.
12005902|NCT00547625|Drug|placebo|Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.
12005903|NCT00547612|Other|high performance liquid chromatography|
12005904|NCT00547612|Other|pharmacological study|
12005905|NCT00547612|Radiation|[18F]-labeled substance P antagonist receptor quantifier|
12005906|NCT00547599|Drug|tadalafil|20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 weeks.
12005907|NCT00547586|Drug|N-methylnaltrexone bromide (MOA-728)|Oral
12005908|NCT00547586|Other|placebo|placebo
12005909|NCT00547573|Drug|tadalafil|10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
12005910|NCT00547573|Drug|tadalafil|20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
12005911|NCT00547573|Drug|placebo|placebo tablet taken by mouth as needed for 12 weeks not more than once a day
12005912|NCT00547560|Drug|GSI-953|Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment.
12005913|NCT00547547|Dietary Supplement|high-selenium Brassica juncea|Dose Level A: 3200 mcg orally day -7 through duration of treatment. Dose Level B: 4800 mcg orally day -7 through duration of treatment. Dose Level C: 6400 mcg orally day -7 through duration of treatment. Dose Level D: 7200 mcg orally day -7 through duration of treatment. Dose Level E: 8000 mcg orally day -7 through duration of treatment.
12005914|NCT00547547|Drug|capecitabine|Dose Level 1: 750 mg/m2, 2x daily x 14 days every 21 days. Dose Level 1.5: 850 mg/m2, 2x daily x 14 days every 21 days. Dose Level 2: 1000 mg/m2, 2x daily x 14 days every 21 days.
12005915|NCT00547547|Drug|irinotecan hydrochloride|Dose Level 1: 100 mg/m2 on day 1 and day 8 every 21 days. Dose Level -1: 75 mg/m2 on day 1 and day 8 every 21 days.
12005916|NCT00547534|Drug|bortezomib|1.3 mg/m^2 on days 1, 4, 8, 11
12005917|NCT00547534|Drug|bendamustine|90 mg/m^2 days 1 and 4
12005918|NCT00547534|Drug|rituximab|375 mg/m^2 day 1
12005919|NCT00547521|Drug|abatacept|solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open
12005920|NCT00547521|Drug|Methotrexate (MTX)|Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks
12005921|NCT00547508|Drug|tadalafil|10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
12005922|NCT00547508|Drug|placebo|Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
12005923|NCT00547508|Drug|tadalafil|20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
12005924|NCT00547508|Drug|tadalafil|20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
12005987|NCT00547131|Other|laboratory biomarker analysis|
12005988|NCT00547131|Other|liquid chromatography|
12005989|NCT00547131|Other|mass spectrometry|
12005925|NCT00547508|Drug|tadalafil|10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
12005926|NCT00547508|Drug|placebo|Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
12005927|NCT00547495|Drug|tadalafil|5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
12005928|NCT00547495|Drug|placebo|placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
12005929|NCT00547495|Drug|tadalafil|10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
12005930|NCT00547495|Drug|tadalafil|20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
12005931|NCT00547482|Device|TANTALUS(TM) System|"All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the Treatment Group or Control Group after surgery at Week 1, Visit 5 (device activation)."
12005932|NCT00547469|Drug|DDP733|
12005933|NCT00547456|Drug|Oxygen|Oxygen 2-3L Nasal cannula
12005934|NCT00547443|Drug|carboplatin|Given IV
12005935|NCT00547443|Drug|paclitaxel|Given IV
12005936|NCT00547443|Drug|sorafenib tosylate|Given orally
12005937|NCT00547443|Radiation|radiation therapy|Given 5 days a week for 7.5 weeks
12005938|NCT00547417|Drug|tadalafil|20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.
12005939|NCT00547404|Drug|P276-00|IV drug infusion over a period of 30 min on day 1,4,8 and 11 in21 day cycle for 6 cycles
12005940|NCT00547391|Procedure|Tonsillectomy|Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.
12005941|NCT00547391|Other|no intervention|No intervention (controls). Follow up started from the day of randomization.
12005942|NCT00547378|Device|InterStim|
12005943|NCT00547378|Drug|Standard Medical Therapy|Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg
12005944|NCT00547365|Biological|Human immune globulin intravenous (IGIV)|Analyze the therapeutic potential of human immune globulin intravenous (IGIV) when given to patients with cardiac-associated AL amyloidosis
12005945|NCT00547352|Drug|tadalafil|20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.
12005946|NCT00547352|Drug|sildenafil|Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.
12005947|NCT00547339|Radiation|stereotactic body radiation therapy|
12005948|NCT00547326|Procedure|treated with osteopatic cranial techniques|treated with osteopatic cranial techniques
12005949|NCT00547326|Procedure|Treatment with placebo|Treatment with placebo
12005950|NCT00547300|Drug|Metoprolol ER|Metoprolol ER once daily, oral administration
12005951|NCT00547300|Drug|Nebivolol|Nebivolol once daily, oral administration
12005952|NCT00547287|Drug|tadalafil|20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.
12005953|NCT00547287|Drug|sildenafil|Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.
12005954|NCT00547274|Drug|MK0767|
12005955|NCT00547261|Drug|SSR97225|every 3 weeks
12005956|NCT00547248|Biological|Synflorix|Intramuscular injection, 1 dose
12005957|NCT00547248|Biological|Tritanrix-HepB|Intramuscular injection, 1 dose
12005958|NCT00547248|Biological|Hiberix|Reconstituted with Tritanrix-Hep B before injection
12005959|NCT00547248|Biological|Polio Sabin|Oral, 1 dose
12005960|NCT00547248|Biological|Poliorix|Intramuscular injection, 1 dose
12005961|NCT00547248|Biological|Prevenar (Wyeth)|Intramuscular injection, 1 dose
12005962|NCT00547235|Biological|therapeutic allogeneic lymphocytes|
12005963|NCT00547235|Procedure|allogeneic bone marrow transplantation|
12005964|NCT00547235|Radiation|total-body irradiation|
12005965|NCT00547209|Drug|air|60% air combined with 40% oxygen for ventilation
12005966|NCT00547209|Drug|Nitrous oxide|60% nitrous oxide combined with 40% oxygen for ventilation
12005967|NCT00547196|Biological|filgrastim|
12005968|NCT00547196|Drug|busulfan|
12005969|NCT00547196|Drug|cyclophosphamide|
12005970|NCT00547196|Drug|cyclosporine|
12005971|NCT00547196|Drug|fludarabine phosphate|
12005972|NCT00547196|Drug|melphalan|
12005973|NCT00547196|Drug|mycophenolate mofetil|
12005974|NCT00547196|Procedure|allogeneic hematopoietic stem cell transplantation|
12005975|NCT00547196|Procedure|umbilical cord blood transplantation|
12005976|NCT00547196|Radiation|total-body irradiation|
12005977|NCT00547183|Drug|tadalafil|2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
12005978|NCT00547183|Drug|tadalafil|5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
12005979|NCT00547183|Drug|placebo|Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks
12005980|NCT00547170|Drug|Doxycycline pre-operatively|"Two capsules of Doxycycline 100 mg before vacuum aspiration Placebo 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)"
12005981|NCT00547170|Drug|Doxycycline post-operatively|"Two capsules of placebo 100 mg before vacuum aspiration Doxycycline 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)"
12005982|NCT00547157|Drug|Panitumumab|Arm 2 consists of panitmumab plus RT
12005983|NCT00547157|Drug|Cisplatin|Cisplatin
12005984|NCT00547144|Drug|Gemcitabine|1000 mg/m2 intravenoulsy once a week according to protocol schedule
12005985|NCT00547144|Procedure|Dendritic Cell Immunotherapy|The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)
12005986|NCT00547131|Drug|temozolomide|
12005990|NCT00547131|Other|pharmacological study|
12005991|NCT00547131|Procedure|conventional surgery|
12005992|NCT00547131|Radiation|stereotactic radiosurgery|
12005993|NCT00547118|Drug|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
12005994|NCT00547118|Drug|Placebo|One placebo tablet given 1 time per day for 112 days.
12005995|NCT00547105|Drug|Erlotinib|Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
12005996|NCT00547105|Radiation|SBRT|SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
12005997|NCT00547092|Drug|tadalafil|10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
12005998|NCT00547092|Drug|sildenafil|25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
12005999|NCT00547066|Biological|veltuzumab|hA20 will be administered intravenously in two doses over two weeks
12006000|NCT00547053|Drug|Amiloride Solution for Inhalation|4.5 mL, Amiloride Solution for Inhalation, Inhaled via Omron Ultrasonic Nebulizer, TID, 6 months
12006001|NCT00547040|Other|no intervention|no intervention
12006002|NCT00547027|Behavioral|print-based physical activity intervention|individually-based, print-based physical activity intervention
12006003|NCT00547027|Behavioral|usual care|print-based materials of nutritional information
12006004|NCT00547014|Drug|Placebo Comparator: Cohort 1 Placebo|Drug: placebo for cohort 1 as single dose
12006005|NCT00547014|Drug|52364 3 mg|3 mg capsule single dose administered orally as a single dose
12006006|NCT00547014|Drug|Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo|Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose
12006007|NCT00547014|Drug|52364 10 mg|Drug: 52364 30 mg capsule as a single dose
12006008|NCT00547014|Drug|52364 30 mg|Drug: 52364 30 mg capsule administered as a single dose
12006009|NCT00547014|Drug|52364 100 mg|Drug 52364 100 mg capsule administered as a single dose
12006010|NCT00547014|Drug|52364 1 mg|1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose
12006011|NCT00547001|Drug|Estradiol|1mg during stabilization & then a taper to 0.75mg, 0.5mg, 0.25mg, 0.125mg.
12006012|NCT00546988|Biological|allogeneic stem cell transplant|
12006013|NCT00546975|Dietary Supplement|Resource Support®|
12006014|NCT00546975|Dietary Supplement|Resource Protein®|
12006015|NCT00546975|Dietary Supplement|Placebo|
12006016|NCT00546949|Procedure|Minimal invasive decompression|foraminotomy, laminotomy, microscopic decompression
12006017|NCT00546949|Procedure|Interspinous Process Decompression (IPD)|Interspinous device
12006018|NCT00546936|Drug|ranibizumab|0.5mg ranibizumab
12006019|NCT00546936|Drug|verteporfin|Photodynamic therapy with verteporfin every 3 months for 1 year
12006020|NCT00546923|Drug|Venlafaxine XR|
12006021|NCT00546910|Drug|Atomoxetine|A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food.
12006022|NCT00546910|Drug|Placebo|3 capsules of placebo have to be taken once daily in the morning, with or without food.
12006023|NCT00546897|Drug|Lenalidomide|
12006024|NCT00546884|Behavioral|MI condition|Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it.
12006025|NCT00546884|Behavioral|GI|The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.
12006026|NCT00546871|Drug|Immune Globulin Intravenous (Human), 10%|Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3
12006027|NCT00546858|Other|Physical Examination|Patients will be invited to be evaluated in the Urology Research office at a future date.
12006028|NCT00546845|Device|Balloon angioplasty|Balloon angioplasty. Only stent if PTA fails
12006029|NCT00546845|Device|Use of self-expanding Expert stent|Nitinol stent
12006030|NCT00546832|Drug|TDS-943 (topical diclofenac sodium 4% spray)|
12006031|NCT00546832|Drug|celecoxib|
12006032|NCT00546832|Other|placebo|
12006033|NCT00546819|Biological|Zoster Vaccine, Live|A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1
12006034|NCT00546819|Biological|Comparator: Placebo|A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.
12006035|NCT00546806|Other|Programs of Care|Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.
12006036|NCT00546793|Biological|veltuzumab|veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
12006037|NCT00546780|Drug|Tanespimycin|Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
12006038|NCT00546780|Drug|Bortezomib|Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
12006039|NCT00546767|Behavioral|Mail and Live Phone|This group will receive assessments of all domains by mail, except for the cognitive performance assessment which will be administered via phone by a live, trained evaluator. Medication compliance will be monitored by a written medication log which will be returned by mail with the other mail-in assessments.
12006040|NCT00546767|Behavioral|Interactive Voice Response (IVR)|In this group, participants will be asked to answer questions via an automated phone system using interactive voice recognition (IVR) and key-pad response entry. Medication compliance will be monitored by the same method. A standard large-key telephone and training in the use of the interactive phone system will be provided to all participants.
12006100|NCT00546364|Drug|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
12006041|NCT00546767|Behavioral|Home-based Computer Kiosk|Participants at entry will receive a special Kiosk-like device for collecting assessment information and will be taught to use this device. The user interface will consist of a monitor with a touch screen and a telephone handset, similar to what is often used in museum displays. Pre-recorded instructions will be delivered through the handset as well as displayed visually on the screen. Data will be collected using the handset's high-quality microphone. Daily activity assessments of timed medication use will be obtained via an automated medication tracking device.
12006042|NCT00546767|Behavioral|Traditional Evaluation Instruments|Evaluation methods typically used in clinical trials
12006043|NCT00546754|Drug|losartan potassium (+) hydrochlorothiazide|losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide
12006044|NCT00546754|Drug|Comparator: Valsartan (+) Hydrochlorothiazide|Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide
12006045|NCT00546741|Drug|Dapagliflozin|Tablets, Oral, 20 mg, once daily single dose
12006046|NCT00546741|Drug|Metformin|Tablets, Oral, 1000 mg, once daily, single dose
12006047|NCT00546741|Drug|Dapagliflozin + Metformin|"Tablets, Oral, once daily, single dose
~Dapagliflozin: 20 mg
~Metformin: 1000 mg"
12006048|NCT00546728|Drug|Exenatide|exenatide 10 mcg twice daily
12006049|NCT00546728|Drug|Metformin|metformin 500 twice daily
12006050|NCT00546715|Drug|Daclatasvir|Oral Solution, Oral, Single Dose
12006051|NCT00546715|Drug|Placebo|Oral Solution, Oral, Single Dose
12006052|NCT00546702|Drug|Insuline Glulisine|
12006053|NCT00546676|Drug|Telithromycin|
12006054|NCT00546663|Drug|inhaled 7% hypertonic saline (HS)|"7% hypertonic saline administered twice daily for 14 days by nebulization.
~A Pari Sprint Junior nebulizer equipped with a Pari Baby face mask and a Pari Proneb compressor will be used to administer the HS (PARI Respiratory Equipment, Inc., Midlothian, VA).
~To minimize the risk of cough and bronchospasm with HS inhalation, infants will be pre-treated prior to each dose of HS with albuterol by metered dose inhaler"
12006055|NCT00546650|Drug|Sumatriptan succinate|NP101 iontophoretic transdermal system
12006056|NCT00546650|Drug|Sumatriptan succinate|oral, subcutaneous, and intranasal formulations
12006057|NCT00546637|Drug|Fesoterodine|Fesoterodine 4mg or 8mg
12006058|NCT00546637|Drug|Placebo|Placebo
12006059|NCT00546624|Drug|MK0777|
12006060|NCT00546611|Drug|PEP005|
12006061|NCT00546598|Device|Total hip replacement/arthroplasty|Hip replacement
12006062|NCT00546585|Biological|Influenza A/H7N7 Vaccine|Monovalent subvirion H7N7 vaccine, 4 dose levels of vaccine, each subject will receive 2 doses (7.5, 15, 45, or 90 micrograms); the same dose will be given at Day 0 and Day 28.
12006063|NCT00546585|Drug|Placebo|Sterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28.
12006064|NCT00546572|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
12006065|NCT00546572|Biological|23vPS|0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
12006066|NCT00546559|Drug|statins (simvastatin, pravastatin)|
12006067|NCT00546546|Drug|early immunosuppressants (azathioprine, methotrexate)|azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated
12006068|NCT00546533|Drug|Etanercept|
12006069|NCT00546520|Drug|Ciclesonide|
12006070|NCT00546507|Drug|TDS-943 (topical diclofenac sodium 4% spray)|
12006071|NCT00546507|Drug|celecoxib|
12006072|NCT00546507|Other|placebo|
12006073|NCT00546494|Drug|Effexor® (Venlafaxine)|
12006074|NCT00546481|Drug|methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]|0.6 micrograms/kg every 2 weeks
12006075|NCT00546481|Drug|Epoetin|As prescribed, iv, 3 times weekly
12006076|NCT00546468|Procedure|laparoscopy assisted distal gastrectomy|under general endotracheal anesthesia, Five laparoscopic ports are made. Lymph node dissection and ligations of vessels are done in laparoscopic field. A 5-6cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, stomach is taken out and resected. A Billroth I gastroduodenostomy using EEA stapler and GIA is performed. Abdomen is closed after hemostasis.
12006077|NCT00546468|Procedure|Open distal gastrectomy|Open distal gastrectomy is performed under general endotracheal anesthesia. A long midline incision is made. omentectomy is skipped and D2 lymph node dissection is performed. Anastomosis is done in same manner as LADG. Abdomen is closed after hemostasis
12006078|NCT00546455|Drug|Fenretinide|200 mg/day
12006079|NCT00546455|Drug|Placebo|2 capsules/day
12006080|NCT00546442|Drug|Metformine|850-2550 mg/daily for 48 weeks
12006081|NCT00546442|Other|Placebo of metformine|850-2550 mg/daily for 48 weeks
12006082|NCT00546429|Device|Intramedullary nailing|Trochanteric nailing for proximal femoral fractures.
12006083|NCT00546403|Drug|Modafinil|Adjunctive treatment with titrated dose of modafinil
12006084|NCT00546403|Drug|Placebo|Adjunctive treatment with placebo
12006085|NCT00546390|Device|Blood Pressure Cuff|The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.
12006086|NCT00546377|Biological|filgrastim|
12006087|NCT00546377|Biological|pegfilgrastim|
12006088|NCT00546377|Biological|rituximab|
12006089|NCT00546377|Biological|sargramostim|
12006090|NCT00546377|Drug|cyclophosphamide|
12006091|NCT00546377|Drug|mitoxantrone hydrochloride|
12006092|NCT00546377|Drug|pentostatin|
12006093|NCT00546377|Genetic|fluorescence in situ hybridization|
12006094|NCT00546377|Genetic|gene rearrangement analysis|
12006095|NCT00546377|Genetic|polymerase chain reaction|
12006096|NCT00546377|Genetic|protein expression analysis|
12006097|NCT00546377|Other|flow cytometry|
12006098|NCT00546377|Procedure|biopsy|
12006099|NCT00546364|Drug|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
12006101|NCT00546364|Drug|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
12006102|NCT00546351|Drug|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
12006103|NCT00546325|Drug|Rimonabant|White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
12006104|NCT00546325|Drug|Placebo|Matching placebo tablets. Once daily before breakfast
12006105|NCT00546312|Device|Thoracic EXCLUDER Endoprosthesis|Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
12006106|NCT00546299|Drug|oxygen|cylinder and concentrator, dosage to maintain SpO2 above 92%, used during exertion
12006107|NCT00546286|Drug|dorzolamide hydrochloride (+) timolol maleate|"Combination treatment of dorzolamide HCl (2%)/ timolol maleate (0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension.
~For patients who achieve target IOP at 6 weeks, dorzolamide/timolol is continued for another 6 weeks."
12006108|NCT00546286|Drug|Comparator: dorzolamide HCl/timolol maleate + prostaglandin|"Combination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension.
~For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks."
12006109|NCT00546273|Biological|RUTI|dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
12006110|NCT00546273|Biological|RUTI|dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
12006111|NCT00546273|Biological|RUTI|dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
12006112|NCT00546273|Biological|RUTI|dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
12006113|NCT00546273|Biological|placebo of the vaccine RUTI|placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28
12006114|NCT00546260|Drug|placebo|administration of iv bolus prior to angiography
12006115|NCT00546260|Drug|PRT060128 Potassium|administration of iv bolus prior to angiography
12006116|NCT00546247|Drug|Epofolate|Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1, 4, 8 and 11 of a 21-day cycle, until the disease progresses
12006117|NCT00546234|Drug|tiotropium|18 mcg daily via Handihaler
12006118|NCT00546234|Drug|long acting beta agonist|Turbohaler, 6 & 12 mcg
12006119|NCT00546221|Behavioral|Psychosocial support exercise programme|The experimental arm will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will comprise: fifteen minutes of psychosocial and motivational support, run by a qualified rehabilitation psychologist and overseen by a qualified health psychologist; a half hour preferred intensity exercise session run by a qualified sports physiotherapist. Participants preferred intensity (chosen exertion level) will be established using the Borg RPE scale (Borg G 1998).
12006120|NCT00546221|Behavioral|Prescribed exercise|This group will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will be an half hour exercise session, at a typically (GP) prescribed level, designed in accordance with national guidelines and run by a qualified sports physiotherapist.
12006121|NCT00546169|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|haemorrhages in cholecystectomy
12006122|NCT00546156|Drug|Doxorubicin|Standard chemotherapy regimen
12006123|NCT00546156|Drug|Cyclophosphamide|Standard chemotherapy regimen
12006124|NCT00546156|Drug|Paclitaxel|Standard chemotherapy regimen
12006125|NCT00546156|Drug|Bevacizumab|One intravenous dose given followed 2 weeks later with standard chemotherapy drugs and bevacizumab given intravenously in 8 two-week cycles.
12006126|NCT00546143|Drug|Omalizumab|
12006127|NCT00546143|Drug|Omalizumab|
12006128|NCT00546143|Drug|Omalizumab|
12006129|NCT00546130|Drug|Irinotecan hydrochloride|"Irinotecan hydrochloride 60 mg/m2, IV (in the vein) on days 1, 8, 15 of each 28 day cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
12006130|NCT00546130|Drug|Cisplatin|Cisplatin 60 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
12006131|NCT00546130|Drug|Krestin|Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
12006132|NCT00546117|Drug|lansoprazole|Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing >30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm.
12006133|NCT00546117|Drug|placebo|Placebo Solutab in 15 and 30 mg dosages.
12006134|NCT00546104|Drug|Dasatinib|An initial dose of 50 mg PO BID; following 4 weeks of treatment, dose adjustment will be based on inhibition of phosphorylation of FAK and paxillin per biopsy assessment, as well as toxicity assessment.
12006135|NCT00546078|Biological|Cervarix™|Intramuscular injection, one or three doses
12006136|NCT00546065|Drug|esomeprazole treatment|concomitant esomeprazole treatment
12006137|NCT00546052|Drug|losartan potassium (+) hydrochlorothiazide|All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.
12006138|NCT00546039|Drug|Genistein|Capsule, 30 mg, oral daily for 3 to 6 weeks
12006139|NCT00546039|Drug|Placebo|Capsule
12006140|NCT00546026|Other|placental function assessment|Formal assessment of placental function in mid-gestation by placental morphology and uterine artery Doppler at 20-22 weeks and re-interpretation of prior biochemical tests for Down's syndrome and spina bifida.
12006141|NCT00546000|Drug|Fluticasone propionate 0.05% lotion|Daily applications
12006142|NCT00545987|Device|TriGrid™ Delivery System|Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.
12006197|NCT00545623|Other|sham acupuncture|sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
12006143|NCT00545987|Device|conventional intramuscular injection|administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection
12006144|NCT00545974|Drug|memantine|memantine 10mg BID
12006145|NCT00545974|Drug|Placebo pill|Placebo pill BID
12006146|NCT00545961|Drug|placebo|mixture, 0.28125 ml/kg twice a day for 7 days
12006147|NCT00545961|Drug|amoxicillin clavulanate acid|mixture 0.28125 ml / kg twice a day for 7 days
12006148|NCT00545948|Drug|Vinorelbine followed by Cisplatin|Vinorelbine 25 mg/m2 IV over 6-10 minutes on days 1 and 8, followed by Cisplatin 75 mg/m2 IV over 60 minutes on day 1 (every 21 days x 4 cycles).
12006149|NCT00545948|Drug|Pemetrexed followed by Cisplatin|Pemetrexed 500 mg/m2 IV infusion over approximately 10 minutes on day 1, followed by Cisplatin 75 mg/m2 IV over 60 min on day 1 (every 21 days x 4 cycles)
12006150|NCT00545935|Drug|Methylenblue-Amodiaquine (MB-AQ)|For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
12006151|NCT00545935|Drug|Methylenblue-Artesunate (MB-AS)|3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
12006152|NCT00545935|Drug|Artesunate-Amodiaquine (AS-AQ)|For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
12006153|NCT00545922|Behavioral|Cognitive behavioral therapy|Seven weekly sessions (2 hrs) in groups
12006154|NCT00545922|Behavioral|Minimal Telephone Contact|Telephone contact (max. 10 minutes) every other week during the 7-week intervention
12006155|NCT00545909|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months (+ feedback)
12006156|NCT00545909|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months (- feedback)
12006157|NCT00545896|Procedure|Extracorporeal shockwave therapy|Extracorporeal application of shockwaves on the surface of chronic wounds.
12006158|NCT00545870|Drug|bevacizumab|intravitreal application
12006159|NCT00545870|Drug|Ranibizumab|intravitreal application
12006160|NCT00545857|Drug|pioglitazone|Pioglitazone daily; dose varies with size
12006161|NCT00545857|Drug|Placebo control|Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
12006162|NCT00545844|Drug|montelukast sodium|montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
12006163|NCT00545831|Device|Taurolidine|2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
12006164|NCT00545831|Device|Physiologic Serum|2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
12006165|NCT00545818|Device|OsseoSpeed™ length 6 mm|OsseoSpeed™ dental implant, length: 6 mm
12006166|NCT00545818|Device|OsseoSpeed™ length 11 mm|OsseoSpeed™ dental implant, length: 11 mm
12006167|NCT00545805|Procedure|Roux-en-Y Gastric Bypass plus total omentectomy|Roux-en-Y Gastric Bypass plus total omentectomy
12006168|NCT00545805|Procedure|Roux-en-Y Gastric Bypass|Roux-en-Y Gastric Bypass without omentectomy
12006169|NCT00545792|Drug|Avastin|Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
12006170|NCT00545779|Drug|Ibandronate|150 mg orally once monthly for 6 months
12006171|NCT00545766|Drug|Vinflunine|Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
12006172|NCT00545753|Drug|Spinosad|10 minute topical application product, following by a complete rinse off.
12006173|NCT00545753|Drug|Spinosad|10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
12006174|NCT00545753|Drug|Permethrin 1%|Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
12006175|NCT00545740|Drug|SPD476 (1.2g)|1.2g SPD476 once daily (QD) orally
12006176|NCT00545740|Drug|SPD476 (2.4 g)|2.4g SPD476 QD orally
12006177|NCT00545740|Drug|SPD476 (4.8 g)|4.8g SPD476 QD orally
12006178|NCT00545740|Drug|Placebo|QD orally
12006179|NCT00545727|Behavioral|Diet|Whole-foods, low glycemic index diet
12006180|NCT00545727|Other|Standard diet|Standard diet meeting American Diabetes Association guidelines
12006181|NCT00545714|Drug|Cyclophosphamide|Cyclophosphamide 250 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
12006182|NCT00545714|Drug|Fludarabine|Fludarabine 25 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
12006183|NCT00545714|Drug|Rituximab|Rituximab 375 mg/m^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
12006184|NCT00545701|Biological|A/H5N1 inactivated, split-virion influenza virus|0.5 mL, Intramuscular
12006185|NCT00545688|Drug|Herceptin|8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
12006186|NCT00545688|Drug|Docetaxel|75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
12006187|NCT00545688|Drug|Pertuzumab|840mg iv loading dose, followed by 420mg iv 3-weekly
12006188|NCT00545675|Drug|Abilify(aripiprazole)|Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
12006189|NCT00545675|Drug|Depakote (divalproate)|Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder
12006190|NCT00545662|Drug|Placebo|Drug Placebo Inactive twice a day given orally or enterally. The first dose is given within 24 hours of injury and treatment continues until 90 days or until the 90-day outcome assessment.
12006191|NCT00545662|Drug|citicoline|1000 mg twice a day orally or enterally. The first dose is within 24 hours of injury and treatment continues for 90-days or until the 90-day outcome assessment.
12006192|NCT00545649|Behavioral|Exercise and education|
12006193|NCT00545649|Behavioral|Education|
12006194|NCT00545636|Other|education|The intervention is an education of the medical teams that instruct children to fast before the administration of general anesthesia
12006195|NCT00545623|Procedure|Acupuncture|acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
12006196|NCT00545623|Behavioral|Relaxation Response|listening to CDs with verbal instructions of techniques to elicit relaxation response
12006198|NCT00545597|Drug|Lorenzo's oil|4:1 glyceryl trioleate-glyceryl trierucate (Lorenzo's oil)given orally, daily as approximately 10% of nutritional calories with supplementation.
12006199|NCT00545584|Drug|sitagliptin phosphate|sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
12006200|NCT00545584|Behavioral|Comparator: Diet|Diet
12006201|NCT00545584|Behavioral|Comparator: Physical Activity|Physical Activity
12006202|NCT00545571|Drug|Methoxy polyethylene glycol-epoetin beta|Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.
12006203|NCT00545558|Drug|Efavirenz|600 mg tablet taken orally daily
12006204|NCT00545558|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally daily
12006205|NCT00545545|Biological|Safety and efficacy of escalating doses|Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle) and irinotecan on Day 1 of each week for 4 weeks with a 2-week rest. Number of Cycles: until progression or unacceptable toxicity develops.
12006206|NCT00545545|Biological|Safety and efficacy of escalating doses.|Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.
12006207|NCT00545532|Drug|oseltamivir|Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
12006208|NCT00545532|Other|placebo|Placebo matched to oseltamivir po twice daily for 10 days
12006209|NCT00545519|Drug|thymoglobulin|
12006210|NCT00545506|Device|conventional bandage|
12006211|NCT00545506|Device|warming bandage|
12006212|NCT00545493|Drug|Tacrolimus|tacrolimus capsules, dosing according to blood trough levels: 12-15 ng/ml during months 1-6, 5-10 ng/ml during months 7-12 and 5-8 ng/ml thereafter
12006213|NCT00545493|Drug|i.v. immunoglobulins|infusions, dosing: initially on three consecutive days 0,4 g/kg KG, thereafter 0,4 g/kg KG every month, after 12 months of treatment every two months).
12006214|NCT00545480|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 12 months (with feedback)
12006215|NCT00545480|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 12 months (without feedback)
12006216|NCT00545467|Drug|Aripiprazole|Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
12006217|NCT00545454|Drug|SSR150106|
12006218|NCT00545454|Drug|Placebos|
12006219|NCT00545441|Device|Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)|Surgical placement of the Surgisis AFP is performed under general anesthesia.
12006220|NCT00545441|Device|Flap|Advancement flap surgery is performed; no anal fistula plug is placed
12006221|NCT00545428|Procedure|Rhinoplasty|Mastoid bone autograft for dorsal nasal augmentation
12006222|NCT00545415|Dietary Supplement|Order 1|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
12006223|NCT00545415|Dietary Supplement|Order 2|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
12006224|NCT00545415|Dietary Supplement|Order 3|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
12006225|NCT00545415|Dietary Supplement|Order 4|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
12006226|NCT00545415|Dietary Supplement|Order 5|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
12006227|NCT00545415|Dietary Supplement|Order 6|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
12006228|NCT00545402|Drug|Mycophenolate mofetil, adjusted dose|3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.
12006229|NCT00545402|Drug|Tacrolimus|Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12
12006230|NCT00545402|Drug|Corticosteroids, IV|10-15 mg/kg IV pre-operation on Day 0
12006231|NCT00545402|Drug|Mycophenolate mofetil, Standard dose|2 g/d PO BID during meals from Day 0 to Month 12
12006232|NCT00545402|Drug|Corticosteroids, PO|20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
12006233|NCT00545389|Drug|SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine|
12006234|NCT00545376|Procedure|Osteopathic Manipulative Treatment - in clinic|I will do a thoracic/rib screening and treatment with muscle energy or facilitated positional release, a diaphragm soft tissue release, suboccipital release, and a thoracic compression. This treatment takes 10 minutes and is only done at the first visit.
12006300|NCT00544921|Drug|GLY-230|
12006235|NCT00545376|Procedure|Osteopathic Manipulative Treatment - at home|One group will learn how to do three home OMT techniques: suboccipital release, pectoral traction, and rib raising. They will be asked to do this at least 4 times a week for two weeks.
12006236|NCT00545376|Other|Education to physicians|I will educate physicians using demonstration and reading material as to the possible benefits of incorporating it into the treatment of asthma.
12006237|NCT00545363|Drug|Ibandronate|Participants will receive ibandronate 150 mg QM orally for 6 months.
12006238|NCT00545350|Other|Fall prevention exercise program|"Weekly physical exercise sessions in small groups, led by a qualified and specially trained instructor, and supplemented by simple exercises to do at home.
~The exercise program will focus on progressive balance retraining but will also include strength/resistance, coordination and flexibility training exercises."
12006239|NCT00545337|Drug|Insuline glulisine|
12006240|NCT00545324|Drug|MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks|
12006241|NCT00545324|Drug|Comparator: Fluticasone / Duration of Treatment: 6 Weeks|
12006242|NCT00545311|Drug|NVA237|
12006243|NCT00545311|Drug|NVA237|
12006244|NCT00545311|Drug|NVA237|
12006245|NCT00545311|Drug|NVA237|
12006246|NCT00545311|Drug|Placebo|
12006247|NCT00545298|Drug|Nitric Oxide - same dose 6 wks|200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound
12006248|NCT00545298|Drug|Nitric Oxide modified treatment|200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound
12006249|NCT00545285|Procedure|Total Hip Arthroplasty|Surgical implantation of specific hip replacement components for treatment of osteoarthritis
12006250|NCT00545272|Drug|indacaterol|Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
12006251|NCT00545272|Drug|formoterol|Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
12006252|NCT00545272|Drug|placebo to indacaterol|Placebo TWISTHALER® device
12006253|NCT00545272|Drug|placebo to formoterol|Placebo AEROLIZER® device
12006254|NCT00545272|Drug|short acting β2-agonist|100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
12006255|NCT00545259|Drug|AEB071|
12006256|NCT00545246|Drug|aflibercept (AVE0005)|intravenous infusion
12006257|NCT00545246|Drug|docetaxel|intravenous infusion
12006258|NCT00545233|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms subcutaneous weekly for 48 weeks
12006259|NCT00545233|Drug|ribavirin [Copegus]|1000-1600 mg day orally for 48 weeks.
12006260|NCT00545233|Drug|Pioglitazone|30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
12006261|NCT00545220|Behavioral|problem-solving training|
12006262|NCT00545220|Behavioral|sham intervention|
12006263|NCT00545207|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 2 years
12006264|NCT00545207|Drug|Placebo|po monthly for 2 years
12006265|NCT00545194|Drug|Prostaglandin E2|
12006266|NCT00545181|Drug|Vaginal acidifying gel (RepHresh)|"placement of vaginal acidifying gel into vagina to restore normal vaginal pH."
12006267|NCT00545181|Drug|Metronidazole control|oral metronidazole therapy alone
12006268|NCT00545168|Drug|Spinosad|10 minute topical application of product, followed by a complete rinse off.
12006269|NCT00545168|Drug|Spinosad|10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.
12006270|NCT00545168|Drug|Permethrin 1%|Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
12006271|NCT00545142|Drug|Abilify(Aripiprazole)|co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
12006272|NCT00545142|Drug|Depakote(Divalproate)|co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
12006273|NCT00545129|Drug|Tanezumab 10 mg IV|Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.
12006274|NCT00545129|Drug|IV Placebo for tanezumab|Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
12006275|NCT00545116|Other|Hesperidin|250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
12006276|NCT00545103|Drug|SPD476, MMX™ mesalazine, 1.2g extended release tablet|SPD476 1.2g administered Once Daily (QD)
12006277|NCT00545103|Drug|SPD476, MMX™ mesalazine, 1.2g extended release tablet|SPD476 2.4g administered Once Daily (QD)
12006278|NCT00545103|Drug|SPD476, MMX™ mesalazine, 1.2g extended release tablet|SPD476 4.8g administered Once Daily (QD)
12006279|NCT00545103|Drug|Placebo|Placebo administered Once Daily (QD)
12006280|NCT00545090|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months
12006281|NCT00545077|Drug|Letrozole|
12006282|NCT00545077|Drug|Bevacizumab|
12006283|NCT00545077|Drug|Fulvestrant|
12006284|NCT00545064|Drug|dorzolamide hydrochloride (+) timolol maleate|dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment
12006285|NCT00545051|Drug|Placebo|po monthly for 12 months
12006286|NCT00545051|Drug|ibandronate|150mg po monthly for 12 months
12006287|NCT00545025|Biological|Influenza Vaccine GSK1247446A|Single dose, Intramuscular injection
12006288|NCT00545025|Biological|Fluarix™|Single dose, Intramuscular injection
12006289|NCT00545012|Drug|Levetiracetam|
12006290|NCT00544999|Drug|cytarabine|
12006291|NCT00544999|Drug|daunorubicin hydrochloride|
12006292|NCT00544999|Drug|everolimus|
12006293|NCT00544999|Other|laboratory biomarker analysis|
12006294|NCT00544999|Other|pharmacological study|
12006295|NCT00544986|Drug|Anastrozole|
12006296|NCT00544960|Drug|AT-101 and docetaxel|AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
12006297|NCT00544960|Drug|placebo and docetaxel|placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
12006298|NCT00544934|Drug|GLY-230|125, 250 0r 375 mg bid for 14 days
12006299|NCT00544934|Other|Placebo|No drug administered
12006301|NCT00544921|Other|Placebo|No drug administered
12006302|NCT00544908|Drug|dasatinib|
12006303|NCT00544908|Other|immunoenzyme technique|
12006304|NCT00544908|Other|immunohistochemistry staining method|
12006305|NCT00544908|Other|laboratory biomarker analysis|
12006306|NCT00544908|Procedure|quality-of-life assessment|
12006307|NCT00544882|Drug|DR-1021|Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
12006308|NCT00544882|Drug|Mircette®|Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
12006309|NCT00544882|Drug|Kariva®|Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
12006310|NCT00544869|Drug|OPC-41061 （Tolvaptan)|15-30mg/day,daily for 14days
12006311|NCT00544856|Behavioral|complex cognitive training|
12006312|NCT00544830|Drug|Bicalutamide|Given PO
12006313|NCT00544830|Drug|Goserelin Acetate|Given SC
12006314|NCT00544830|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
12006315|NCT00544830|Other|Laboratory Biomarker Analysis|Correlative studies
12006316|NCT00544830|Drug|Leuprolide Acetate|Given via injection
12006317|NCT00544817|Radiation|Radiation Therapy|2 Gy/fraction, single daily fractions M-F, to 60 Gy total
12006318|NCT00544817|Drug|Temozolomide|"In Combined Modality Therapy, administered as 75 mg/m2 by mouth once daily
~In follow-up systemic therapy, administered as 150 mg/m2 by mouth on days 1-5 every 28 days for 6 cycles"
12006319|NCT00544817|Drug|Sorafenib|In follow-up systemic therapy, administered as 400 mg by mouth twice daily for 6 months
12006320|NCT00544804|Drug|lapatinib ditosylate|
12006321|NCT00544804|Genetic|gene expression analysis|
12006322|NCT00544804|Other|diagnostic laboratory biomarker analysis|
12006323|NCT00544791|Drug|melatonin|5 mg, oral, daily dose for 6 months
12006324|NCT00544791|Drug|placebo like melatonin tablets|
12006325|NCT00544778|Biological|filgrastim|
12006326|NCT00544778|Drug|dexrazoxane hydrochloride|
12006327|NCT00544778|Drug|doxorubicin hydrochloride|
12006328|NCT00544778|Drug|ifosfamide|
12006329|NCT00544778|Drug|irinotecan hydrochloride|
12006330|NCT00544778|Genetic|protein expression analysis|
12006331|NCT00544778|Other|immunoenzyme technique|
12006332|NCT00544778|Procedure|adjuvant therapy|
12006333|NCT00544778|Procedure|conventional surgery|
12006334|NCT00544778|Procedure|neoadjuvant therapy|
12006335|NCT00544778|Radiation|radiation therapy|
12006336|NCT00544765|Drug|TAC|Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks
12006337|NCT00544765|Drug|NX|Vinorelbine 25 mg/m² as a < 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks
12006338|NCT00544752|Other|16|indoor temperature of 16 degrees celcius
12006339|NCT00544752|Other|indoor temperature of 20 degrees celcius|indoor temperature of 20 degrees celcius
12006340|NCT00544752|Other|indoor temperature of 24 degrees celcius|indoor temperature of 24 degrees celcius
12006341|NCT00544726|Behavioral|Physical training|
12006342|NCT00544726|Behavioral|No training|
12006343|NCT00544713|Drug|Carboxymethylcellulose and Glycerin based artificial tear|As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
12006344|NCT00544713|Drug|Carboxymethylcellulose|As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
12006345|NCT00544700|Biological|bevacizumab|7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity
12006346|NCT00544700|Other|no maintenance|No treatment until progression
12006347|NCT00544687|Drug|CRx-191|topical (mometasone furoate + nortriptyline HCl)
12006348|NCT00544687|Drug|mometasone furoate|topical mometasone furoate
12006349|NCT00544687|Drug|nortriptyline HCl|topical nortriptyline HCl
12006350|NCT00544687|Drug|Karison® Creme|topical Karison® Creme (clobetasol-17-propinate 0.05%)
12006351|NCT00544687|Drug|Vehicle|topical (placebo)
12006352|NCT00544674|Drug|PR104|administered at a dose of 1100 mg/m^2 by intravenous infusion over 1 hour and repeated every three weeks
12006353|NCT00544674|Other|F-18-fluoromisonidazole|administered intravenously prior to PET scan
12006354|NCT00544648|Drug|carboplatin|(AUC 2) through a vein over 30 minutes following nab-paclitaxel, once per week x 7 weeks
12006355|NCT00544648|Drug|nab-paclitaxel|Phase I: beginning at 40 mg/m2 through a vein over 30 minutes once per week x 7 weeks Phase II: Maximum tolerated dose through a vein over 30 minutes once per week x 7 weeks
12006356|NCT00544648|Radiation|Radiation therapy|3D conformal radiotherapy or Intensity-Modulated Radiation Therapy (IMRT), 2.0 Gy per day x 5 days per week for 33 days during Weeks 1-7 ; Total Dose = 66 Gy
12006357|NCT00544635|Device|no intervention|no intervention
12006358|NCT00544635|Device|light|scars will be treated with light
12006359|NCT00544622|Procedure|structured therapeutic chain of stroke treatment|
12006360|NCT00544609|Drug|Sorafenib|Level 1: 200 mg/day Level 2: 400mg/day Level 3: 800mg/day
12006361|NCT00544609|Procedure|Radiotherapy|3th-8th week: sorafenib daily with radiotherapy day 1, 2, 3, 4 and 5, 9th week: sorafenib daily with radiotherapy day 1 and 2
12006362|NCT00544596|Drug|R-(-)-gossypol acetic acid|Given orally
12006363|NCT00544596|Drug|cisplatin|Given IV
12006364|NCT00544596|Drug|etoposide|Given IV
12006365|NCT00544583|Procedure|Interrupted sutures|Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
12006366|NCT00544583|Procedure|Continuous sutures|Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops
12006367|NCT00544570|Biological|filgrastim|
12006368|NCT00544570|Drug|carmustine|
12006369|NCT00544570|Drug|cyclophosphamide|
12006370|NCT00544570|Drug|etoposide|
12006371|NCT00544570|Drug|melphalan|
12006372|NCT00544570|Procedure|autologous hematopoietic stem cell transplantation|
12006373|NCT00544570|Procedure|peripheral blood stem cell transplantation|
12006374|NCT00544570|Radiation|radiation therapy|
12006375|NCT00544570|Radiation|total-body irradiation|
12006376|NCT00544557|Drug|Etanercept|The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
12006377|NCT00544544|Drug|Riluzole|50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks
12006378|NCT00544518|Drug|metformin|2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time
12006379|NCT00544518|Drug|benfluorex|2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time, one of 2 tablets is dummy tablet.
12006380|NCT00544505|Drug|Fluorouracil/Epirubicin/Cyclophosphamide|Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer
12006381|NCT00544492|Device|catheter for AV fistula cannulation|catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
12006382|NCT00544466|Drug|fludarabine phosphate|25 mg/m2 day -7 through day -3 prior to transplant
12006383|NCT00544466|Drug|melphalan|140 mg/m2 day -2 prior to transplant
12006384|NCT00544466|Procedure|allogeneic hematopoietic stem cell transplantation|Cells infused on Day 0 of transplant regimen
12006385|NCT00544466|Radiation|intensity-modulated radiation therapy|Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
12006386|NCT00544453|Drug|[123I] MNI-308|Injection of [123I] MNI-308 and SPECT scanning
12006387|NCT00544440|Drug|Abiraterone acetate|Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
12006388|NCT00544440|Drug|Prednisone|Prednisone 5 mg tablet taken orally twice daily
12006389|NCT00544427|Device|Optical coherence tomography|Optical coherence tomography imaging
12006390|NCT00544414|Drug|cisplatin|
12006391|NCT00544414|Drug|docetaxel|
12006392|NCT00544414|Drug|fluorouracil|
12006393|NCT00544414|Drug|gemcitabine hydrochloride|
12006394|NCT00544414|Drug|leucovorin calcium|
12006395|NCT00544414|Genetic|gene expression analysis|
12006396|NCT00544414|Genetic|protein expression analysis|
12006397|NCT00544414|Other|laboratory biomarker analysis|
12006398|NCT00544414|Procedure|adjuvant therapy|
12006399|NCT00544414|Procedure|biopsy|
12006400|NCT00544414|Procedure|conventional surgery|
12006401|NCT00544414|Procedure|neoadjuvant therapy|
12006402|NCT00544414|Procedure|quality-of-life assessment|
12006403|NCT00544414|Radiation|radiation therapy|
12006404|NCT00544401|Other|Hypnopuncture (Hypnosis+Acupuncture)|hypnosis and acupuncture
12006405|NCT00544388|Drug|levocetirizine dihydrochloride|
12006406|NCT00544375|Device|Optical measurement|Optical measurement neonatal tissues
12006407|NCT00544362|Biological|cetuximab|
12006408|NCT00544362|Drug|cisplatin|
12006409|NCT00544362|Drug|fluorouracil|
12006410|NCT00544362|Procedure|conventional surgery|
12006411|NCT00544349|Biological|cetuximab|
12006412|NCT00544349|Drug|fluorouracil|
12006413|NCT00544349|Drug|leucovorin calcium|
12006414|NCT00544349|Drug|oxaliplatin|
12006415|NCT00544336|Other|questionnaire administration|no intervention
12006416|NCT00544336|Other|survey administration|no intervention
12006417|NCT00544336|Procedure|quality-of-life assessment|no intervention
12006418|NCT00544323|Device|oral implant|
12006419|NCT00544310|Biological|Anti adhesion agent|Adhesions prevention
12006420|NCT00544297|Drug|PEP005 gel|Two day application, 0.05%
12006421|NCT00544284|Drug|bortezomib|
12006422|NCT00544284|Drug|temozolomide|
12006423|NCT00544284|Other|pharmacological study|
12006424|NCT00544271|Biological|INFANRIX|
12006425|NCT00544271|Biological|BOOSTRIX|
12006426|NCT00544271|Biological|HAVRIX|
12006427|NCT00544258|Drug|PEP005|
12006428|NCT00544245|Behavioral|Self monitoring of estimated energy balance|Participant estimation of energy intake and energy expenditure
12006429|NCT00544232|Drug|Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa|"Epirubicin (90 mg/m2) d1, q21d - 4× / cyclophosphamide (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×
~+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first epirubicin dose (day 1) to 14 days after the last dose of paclitaxel"
12006430|NCT00544232|Drug|Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa|"Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg, subcutaneous injection on day 2 after epirubicin and/or paclitaxel and secondary prophylactic dose after CMF
~+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first dose of epirubicin (day 1) until 14 days after the last dose of CMF"
12006431|NCT00544219|Biological|rituximab|375 mg/m2 i.v. per cycle
12006432|NCT00544219|Drug|cyclophosphamide|750 mg/m2 i.v. per cycle
12006433|NCT00544219|Drug|doxorubicin hydrochloride|50 mg/m2 i.v. per cycle
12006434|NCT00544219|Drug|prednisone|100 mg/day p.o. per cycle
12006435|NCT00544219|Drug|vincristine sulfate|1.4 mg/m2 (max. 2.0 mg) i.v. per cycle
12006436|NCT00544219|Procedure|positron emission tomography|PET Scan during treatment
12006437|NCT00544206|Other|standard enteral feeding product|16 hrs daily x 5 days
12006438|NCT00544206|Other|Diabetes specific feeding product|16 hrs daily for 5 days
12006439|NCT00544193|Drug|gemcitabine hydrochloride|
12006440|NCT00544193|Genetic|polymerase chain reaction|
12006441|NCT00544193|Other|immunohistochemistry staining method|
12006442|NCT00544193|Procedure|conventional surgery|
12006443|NCT00544193|Radiation|intraoperative radiation therapy|
12006444|NCT00544193|Radiation|radiation therapy|
12006451|NCT00544128|Drug|lamivudine, abacavir , ritonavir, atazanavir|Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
12006452|NCT00544128|Drug|emtricitabine, tenofovir, ritonavir, atazanavir|Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.
12006453|NCT00544115|Drug|busulfan|
12006454|NCT00544115|Drug|cyclophosphamide|
12006455|NCT00544115|Drug|cyclosporine|
12006456|NCT00544115|Drug|etoposide|
12006457|NCT00544115|Drug|fludarabine phosphate|
12006458|NCT00544115|Drug|melphalan|
12006459|NCT00544115|Drug|methotrexate|
12006460|NCT00544115|Drug|mycophenolate mofetil|
12006461|NCT00544115|Drug|sirolimus|
12006462|NCT00544115|Drug|tacrolimus|
12006463|NCT00544115|Procedure|allogeneic hematopoietic stem cell transplantation|
12006464|NCT00544115|Procedure|peripheral blood stem cell transplantation|
12006465|NCT00544115|Radiation|total-body irradiation|
12006466|NCT00544076|Drug|sildenafil citrate|Given orally
12006467|NCT00544076|Drug|alprostadil|Given intraurethrally
12006468|NCT00544076|Procedure|robotic-assisted laparoscopic surgery|Undergo prostatectomy
12006469|NCT00544076|Procedure|quality-of-life assessment|Ancillary studies
12006470|NCT00544076|Other|questionnaire administration|Ancillary studies
12006471|NCT00544063|Drug|irinotecan hydrochloride|
12006472|NCT00544063|Drug|oxaliplatin|
12006473|NCT00544050|Drug|Levetiracetam|
12006474|NCT00544037|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Standard Therapy for Multiple Sclerosis
12006475|NCT00544011|Biological|bevacizumab|
12006476|NCT00544011|Drug|capecitabine|
12006477|NCT00544011|Drug|fluorouracil|
12006478|NCT00544011|Drug|irinotecan hydrochloride|
12006479|NCT00544011|Other|diagnostic laboratory biomarker analysis|
12006480|NCT00543998|Device|Optical Measurement transillumination|Optical Measurement of sinus
12006481|NCT00543985|Procedure|Stress Echocardiography|Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
12006482|NCT00543972|Drug|AVE9633|Intravenous Infusion
12006483|NCT00543959|Drug|MK0533|Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.
12006484|NCT00543959|Drug|Comparator: Placebo (unspecified)|MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
12006485|NCT00543959|Drug|Comparator: pioglitazone|pioglitazone 45mg. Study period is a total of 24 wks.
12006486|NCT00543946|Drug|GAP-134|24-Hour IV infusion, SAD
12006487|NCT00543933|Drug|iNO administered|iNO at 40 ppm through a non-rebreather mask for 5 minutes
12006488|NCT00543920|Drug|MK0777|
12006489|NCT00543881|Device|Remote patient monitoring (Partnership for the Heart)|Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits plus daily monitoring of ECG, weight, blood pressure, self-report of health status, weekly monitoring of physical fitness
12006490|NCT00543881|Device|Usual care group|Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits
12006491|NCT00543868|Drug|MK0782|
12006492|NCT00543855|Drug|3 mg Donepezil hydrochloride|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
12006493|NCT00543855|Drug|5 mg Donepezil hydrochloride|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
12006494|NCT00543855|Drug|10 mg Donepezil hydrochloride|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."
12006495|NCT00543855|Drug|Placebo|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
12006496|NCT00543842|Drug|Bevacizumab|5 mg/kg By Vein Every 2 Weeks x 3 Doses (Weeks 1, 3, 5)
12006497|NCT00543842|Drug|Capecitabine|Starting Dose 650 mg/m^2 By Mouth Twice Daily Monday-Friday x 6 Weeks
12006498|NCT00543842|Drug|Erlotinib|Starting Dose 50 mg By Mouth Daily Weeks 1-3
12006499|NCT00543842|Radiation|Radiation Therapy|30 minute radiation treatments, dose of 50.4 Gy once daily on 5 consecutive days, for up to 5 weeks and 3 days, totaling 28 treatments
12006500|NCT00543842|Procedure|Surgery|At least 8 weeks after radiation therapy, surgical removal of rectal tumor
12006501|NCT00543829|Drug|doxorubicin, docetaxel, tamoxifen|Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) with tamoxifen (30 mg tablet p.o. for 5 years post surgery)
12006502|NCT00543829|Drug|doxorubicin, docetaxel|Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion)
12006503|NCT00543816|Drug|MK0767|
12006504|NCT00543790|Drug|PRA-027|PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
12006505|NCT00543777|Diagnostic Test|Magnetic Resonance Elastogram|Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.
12006506|NCT00543777|Diagnostic Test|2-Point Dixon Magnetic Resonance Imaging|Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
12006507|NCT00543764|Other|pathway|Comparison of pre and post pathway
12006508|NCT00543751|Drug|MK0767|
12006509|NCT00543738|Drug|MK0767|
12006510|NCT00543725|Drug|TMC278|25 mg tablet once daily for 96 weeks
12006511|NCT00543725|Drug|efavirenz|600 mg tablet once daily for 96 weeks
12006512|NCT00543712|Drug|PRO95780|Intravenous repeating dose
12006513|NCT00543686|Drug|Montelukast|Intake of Montelukast
12006514|NCT00543686|Drug|Fluticasone|Intake of Fluticasone
12006515|NCT00543673|Other|Milk based formula A|feed as per HCP directions
12006516|NCT00543673|Other|#2 Standard formula|Feed as per HCP directions
12006517|NCT00543673|Other|#3 Human Milk|Feed as per HCP directions
12006518|NCT00543673|Other|Milk based formula C|Feed as per HCP direction
12006519|NCT00543660|Procedure|Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)|
12006520|NCT00543647|Drug|Fenofibrate 160 mg tablet|
12006521|NCT00543647|Drug|Placebo|
12006522|NCT00543634|Drug|Premarin/MPA|0.625 mg/2.5 mg X4
12006523|NCT00543634|Drug|Premarin/MPA|0.625 mg/5 mg X 2
12006524|NCT00543634|Drug|Provera 10 mg|2.5 mg of MPA, 4 tablets dissoved in water
12006525|NCT00543621|Other|daily enteral nutritional product and/or behavioral changes|
12006526|NCT00543608|Drug|iclaprim|
12006527|NCT00543608|Drug|vancomycin|
12006528|NCT00543595|Drug|MK0916|
12006529|NCT00543582|Drug|MGCD0103 and Azacitidine|"In Part 1 of the study, up to 22 people to enroll will receive a single, oral dose (75 mg gelcap) of MGCD0103 and FB-MGCD0103 during their first 2 weeks in the study. Up to 22 additional people will receive a single dose of both MGCD0103 and TA-FB-MGCE0103. The next group of people to enroll will receive 2 different single doses (25, 50, 100 mg) of FB-MGCD0103 or TA-FB-MGCD0103 during their first 2 weeks in the study.
~In Part 2 of the study, from Day 1-5 of each 28-day cycle, all subjects will receive a dose of azacitidine (75 mg/m2) either subcutaneously or through an intravenous device, and on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, a single, oral dose (85 mg) of MGCD0103 until progression or unacceptable toxicity develops."
12006530|NCT00543569|Drug|Alefacept|Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
12006531|NCT00543569|Drug|tacrolimus|The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
12006532|NCT00543569|Drug|basiliximab|Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
12006533|NCT00543569|Drug|mycophenolate mofetil|Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
12006534|NCT00543569|Drug|Corticosteroids|Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
12006535|NCT00543556|Drug|MK0767|
12006536|NCT00543543|Biological|Comparator: GARDASIL|GARDASIL (quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen
12006537|NCT00543543|Biological|Experimental: V503|V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen (and a fourth injection for Cohort 1 only).
12006538|NCT00543530|Drug|MK0831|
12006539|NCT00543517|Drug|MK0767|
12006540|NCT00543504|Drug|Bevacizumab|2.5 mg/kg By Vein Over 90 Minutes.
12006541|NCT00543504|Drug|Sorafenib|200 mg By Mouth Daily for 28 Days
12006542|NCT00543504|Drug|Erlotinib|50 mg By Mouth Daily for 28 Days.
12006543|NCT00543504|Drug|Trastuzumab|Loading 2 mg/kg by vein then Maintenance 1 mg/kg by vein on Day 1
12006544|NCT00543504|Drug|Lapatinib|250 mg By Mouth Daily for 21 Days.
12006545|NCT00543504|Drug|Sunitinib|12.5 mg orally daily for 4 weeks, then 2 weeks off.
12006546|NCT00543504|Drug|Cetuximab|Loading 100 mg/m² by vein and Maintenance 75 mg/m² by vein on Days 1, 8, 15, 22
12006547|NCT00543491|Drug|MK0767|
12006548|NCT00543478|Drug|Saccharomyces boulardii|250mg, twice a day in sachets, for 8 weeks
12006549|NCT00543478|Drug|Methyl cellulose powder (low viscosity)|twice a day sachets for 10 weeks
12006550|NCT00543465|Drug|MK0782|
12006551|NCT00543452|Other|Oxygen|4 liters of oxygen a minute
12006552|NCT00543452|Other|Air from a placebo oxygen delivery|4 liters a minute of air from a placebo device
12006553|NCT00543439|Biological|Moroctocog alfa (AF-CC)|On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.
12006554|NCT00543439|Biological|Moroctocog alfa (AF-CC)|"Routine prophylaxis crossover:
~45 IU/kg, administered 2 times a week for 1 year followed by 25 IU/kg administered every other day for 1 year, or, 25 IU/kg, administered every other day for 1 year, followed by 45 IU/kg, administered 2 times a week for 1 year."
12006555|NCT00543426|Drug|Fuzheng Huayu Tablets|Tablet,three times a day,four tablets one time
12006556|NCT00543426|Drug|sham Fuzheng Huayu Tablets (placebo)|Tablet, three times a day, four tablets one time
12006557|NCT00543413|Drug|MK8141|MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
12006558|NCT00543413|Drug|Comparator: placebo (unspecified)|MK8141 Pbo tablet once daily. 4 week treatment period.
12006559|NCT00543413|Drug|Enalapril|Enalapril 20 mg tablet once daily. 4 week treatment period.
12006560|NCT00543400|Drug|M118|intravenous (IV) infusion
12006561|NCT00543400|Drug|Unfractionated Heparin|IV infusion
12006562|NCT00543387|Drug|MK-5108|MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.
12006563|NCT00543387|Drug|docetaxel|Docetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m^2 Q12H during the first 2 days of each 21-day cycle.
12006564|NCT00543374|Drug|Placebo|Placebo
12006565|NCT00543374|Drug|PROCHYMAL adult human mesenchymal stem cells|intravenous infusion four times over two weeks; possibly repeated once
12006566|NCT00543361|Drug|MK0767|Duration of Treatment: 52 Weeks
12006567|NCT00543361|Drug|Comparator: placebo (unspecified)|Duration of Treatment: 52 Weeks
12006568|NCT00543361|Drug|Comparator: metformin|Duration of Treatment: 52 Weeks
12006569|NCT00543348|Procedure|CUTTING BALLOON ANGIOPLASTY|CUTTING BALLOON
12006570|NCT00543348|Procedure|HIGH PRESSURE BALLOON|
12006571|NCT00543335|Drug|Sorafenib|Starting dose 200 mg PO (by mouth) Daily
12006572|NCT00543335|Procedure|Radiation Therapy|45 Gy total in 15 radiation treatments: 3 Gy per day, 5 days a week for 3 weeks
12006573|NCT00543309|Drug|nesiritide|Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted
12006574|NCT00543309|Drug|milrinone|Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted
12006575|NCT00543309|Drug|placebo|Placebo bolus on CPB, then placebo infusion
12006576|NCT00543296|Drug|0.59 mg Fluocinolone Acetonide implant|0.59 mg Fluocinolone Acetonide implant
12006577|NCT00543270|Device|Powerlink infrarenal bifurcated stent graft delivery system|Endovascular abdominal aortic aneurysm repair
12006578|NCT00543270|Procedure|Open Surgery|Open surgical abdominal aortic aneurysm repair
12006579|NCT00543257|Other|Use of paper forms to write down information|Parents will be asked to write down information specific to their child's ADHD using paper forms.
12006580|NCT00543257|Other|Computer|Parents will use a computer to complete data entry on information specific to their child's ADHD care
12006581|NCT00543244|Drug|Pegylated interferon alfa and ribavirin|"Pegylated interferon alfa-2a 180 ug/week or pegylated interferon alfa-2b 1.5 ug/kg/week Ribavrin 800-1200 mg/day (genotype 1: < 75 kg 1000 mg/day, >=75 kg 1200 mg/day; genotype 2: 800 mg/day)
~HCV genotype: baseline (Day 0) HCV RNA (real time PCR test): baseline (Day 0), Day 1 (4,8,12 hours after pegylated interferon + ribavirin), Day 2 (24,36 hours), Day 3(48 hours), Day 4 (72 hours), Day 5 (96 hours), Week 2,4,6,8,12,16,20,24, and 28,32,36,40,44,48,72 (for genotype 1 with 48 weeks of treatment), and 48 (for genotype 1 or 2 with 24 weeks of treatment)"
12006582|NCT00543231|Drug|G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide|
12006583|NCT00543218|Drug|teriparatide 20 micrograms/day subcutaneous|
12006584|NCT00543218|Drug|calcitonin 100 IU/day subcutaneous|
12006585|NCT00543205|Drug|Genasense® (G3139, oblimersen sodium)|Genasense 7 mg/kg/day for 5 days
12006586|NCT00543179|Drug|Somatuline (Lanreotide Autogel®)|
12006587|NCT00543166|Drug|dehydroepiandrosterone|50 mg of dehydroepiandrosterone in the morning for 4 months in the treatment group.
12006588|NCT00543153|Behavioral|Interview|Interview lasting approximately 30-45 minutes.
12006589|NCT00543140|Device|REALIZE™ Swedish Adjustable Gastric Band|Laparoscopic placement of the Swedish Adjustable Gastric Band
12006590|NCT00543127|Drug|Fulvestrant|500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.
12006591|NCT00543127|Drug|Anastrozole|1 mg oral Anastrozole per day during 5 years.
12006592|NCT00543114|Drug|Lenalidomide|Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period
12006593|NCT00543114|Drug|Fludarabine|Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days
12006594|NCT00543114|Drug|Rituximab|Given intravenously on Day 1 of each 28 day cycle
12006595|NCT00543101|Drug|Darunavir (DRV/r)|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
12006596|NCT00543101|Drug|continue on current dual boosted PI|Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks
12006597|NCT00543075|Drug|Genasense (oblimersen, G3139)|3 mg/kg/day by intravenous infusion for up to 48 hours
12006598|NCT00543062|Drug|Inhaled placebo|Inhaled Staccato placebo (0 mg)
12006599|NCT00543062|Drug|Oral placebo|Oral placebo (identical to 400 mg moxifloxacin)
12006600|NCT00543062|Drug|Inhaled prochlorperazine 5 mg|Staccato prochlorperazine 5 mg, single dose
12006601|NCT00543062|Drug|Inhaled prochlorperazine 10 mg|Inhaled prochlorperazine 10 mg, single dose
12006602|NCT00543062|Drug|Oral moxifloxacin|Oral moxifloxacin 400 mg, si/ngle dose
12006603|NCT00543049|Drug|Sunitinib|Sunitinib, oral, 50mg once daily, 28 days then paused for 14 days, for up to one year
12006604|NCT00543049|Drug|SUNITINIB|Sunitinib, oral, 37,5 mg once daily continuously, up to one year
12006605|NCT00543036|Device|H-Coil deep TMS|
12006606|NCT00543023|Drug|teriparatide 20 micrograms/day subcutaneous|
12006607|NCT00543023|Drug|salmon calcitonin 100 IU/day subcutaneous|
12006608|NCT00543010|Drug|MK0767|
12006609|NCT00542997|Biological|Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.
12006610|NCT00542984|Drug|teriparatide 20 micrograms/day subcutaneous|
12006611|NCT00542984|Drug|salmon calcitonin 100 IU/day subcutaneous|
12006612|NCT00542971|Drug|Idarubicin|12 mg/m^2 IV over 1 hour daily (days 1-3)
12006613|NCT00542971|Drug|Sorafenib|Starting dose 400 mg by mouth for 7 days
12006614|NCT00542971|Drug|Ara-C|1.5 g/m^2 IV over 24 hours daily (days 1-4)
12006615|NCT00542958|Drug|NK012|9.0, 12.0, 16.0, 21.0, 28.0 mg/m^2, and to be determined. Intravenous infusion
12006616|NCT00542945|Device|ICD|Implantation of an ICD
12006617|NCT00542945|Other|Optimal medical treatment|ACE-inhibitors or ARB Beta-blocker Optional aldosterone antagonist
12006618|NCT00542932|Other|Exercise|"Watched Film A (promotional film)
~Film B (30 min exercise video) asked to to perform 4 times a week for 6 weeks at home"
12006619|NCT00542919|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily until progressive disease
12006620|NCT00542906|Other|localization|localization of the several types of somatosensory stimuli
12006621|NCT00542893|Drug|Genasense® (G3139, oblimersen sodium)|
12006622|NCT00542893|Drug|Genasense followed by DTIC; then DTIC alone|Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
12006623|NCT00542893|Drug|DTIC alone; then Genasense followed by DTIC|Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
12006624|NCT00542880|Drug|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg|
12006625|NCT00542880|Drug|Seretide Diskus (salmeterol/fluticasone) 50/500 μg|
12006626|NCT00542854|Device|MP3|4 different brands of MP3 players will be tested at 3 distances from ICD/pacemaker site in children and adults with congenital heart disease.
12006627|NCT00542841|Procedure|Hydrocortisone withdrawal|This is considered a non-standard treatment. On Day 1, participants will receive one 10-mg pill of hydrocortisone. On Day 3, participants will receive intravenously a medicine called cosyntropin, a synthetic form of a hormone that the body makes. Participants will receive one last pill of hydrocortisone prior to the end of the study.
12006628|NCT00542828|Biological|Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG)|All patients were to be treated with rATG 3.75 mg/kg/day administered by intravenous (IV) infusion over ≥6 hours for 5 consecutive days (cumulative dose: 18.75 mg/kg)
12006629|NCT00542815|Drug|MCI-196|3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
12006630|NCT00542815|Drug|Another Phosphate binder (Sevelamer)|Current approved dosing recommendations for 12 weeks
12006631|NCT00542802|Drug|Levetiracetam|Levetiracetam tablets 250-500 mg. The drug dosage will be up-titrated from 250 mg bid in the first 2 weeks to 500 mg bid during the rest of the treatment period. The dosage can be incremented until 1500 mg bid, at Investigator judgement if crisis continue, or it can be reduced in case of adverse events
12006632|NCT00542802|Drug|Carbamazepine|Carbamazepina tablets 200 mg. The drug dosage will be up-titrated from 100 mg die in the first 3 days to 100 mg bid during days 4 to 7, to 200 mg bid in the 2nd week, to 300 mg bid during the rest of the treatment period. The dosage can be incremented until 800 mg bid, at Investigator judgement if crisis continue, or it can be reduced in case of adverse events
12006633|NCT00542789|Drug|Esomeprazole|20mg once daily oral
12006634|NCT00542789|Drug|Placebo|once daily oral
12006635|NCT00542776|Other|blood draw|drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)
12006636|NCT00542763|Drug|Mycophenolate sodium|Medical treatment is initiated with one tablet of 360 mg mycophenolate sodium orally per day for eligible patient. The dosage will be increased weekly by 360 mg up to a maximum stable dose of 1440mg daily. In patients not well tolerating the drug the dosage can be reduced to 720 mg per day.
12006637|NCT00542750|Drug|N-Acetylcysteine|N-Acetylcysteine 1200 mg twice daily for four weeks
12006638|NCT00542737|Behavioral|Web-Based Educational Program|Participating clinicians at each hospital will access the Web site as often as necessary for a 6-month period. The Web site will contain background and educational information on ALI/ARDS and LPV, including how to recognize ALI/ARDS and how to implement LPV in patients. Scholarly articles and other materials, including a chart to help clinicians determine appropriate ventilator settings for each patient, will be available to download. Clinicians will also be able to email questions to critical care experts.
12006639|NCT00542724|Drug|VIAject™|Dosage as individually required
12006640|NCT00542724|Drug|Regular Human Insulin|Dosage as individually required
12006641|NCT00542711|Drug|liquid tumeric/curcumin extract|30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose.
12006642|NCT00542698|Behavioral|Effect of Physical Activity on Type II Diabetes Mellitus|Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.
12006643|NCT00542685|Drug|PD 0332334|Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
12006644|NCT00542685|Drug|Placebo|Capsules, oral, placebo BID, 8 weeks with 2 week taper.
12006645|NCT00542685|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
12006646|NCT00542685|Drug|PD 0332334|Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
12006647|NCT00542646|Procedure|Endovascular Intervention|Peritoneal Lined Stent Endovascular Intervention
12006648|NCT00542633|Drug|VIAject™|Dosage as individually required
12006649|NCT00542633|Drug|Regular Human Insulin|Dosage as individually required
12006650|NCT00542620|Drug|insulin detemir|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart
12006651|NCT00542620|Drug|insulin aspart|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir
12006652|NCT00542620|Drug|insulin detemir|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart
12006653|NCT00542620|Drug|insulin aspart|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir
12006654|NCT00542607|Drug|levocetirizine dihydrochloride|
12006655|NCT00542581|Device|The Acrysof toric SN60T3 IOL|Intraocular Lens
12006656|NCT00542568|Biological|EPODURE (dermal Biopump for erythropoietin)|Subjects will undergo similar study procedures and evaluations; however each dosage group will receive a different targeted dose of EPO delivered via EPODURE Biopump
12006657|NCT00542555|Drug|Placebo|At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
12006658|NCT00542555|Drug|Naproxcinod 375 mg|
12006659|NCT00542555|Drug|Naproxen|
12006660|NCT00542555|Drug|Naproxcinod 750 mg|
12006661|NCT00542542|Procedure|Paravertebral Block|Paravertebral block given as a bolus injection into the paravertebral space.
12006662|NCT00542542|Drug|Propofol|2-2.5 mg/kg IV over 1-4 hours during surgery.
12006663|NCT00542542|Drug|Fentanyl|50-250 mcg IV over 1-4 hours during surgery.
12006664|NCT00542542|Drug|Ropivacaine|Ropivacaine given by injection into the paravertebral space along the spinal canal.
12006665|NCT00542542|Drug|Midazolam|0.08 mg/kg IV over 1-4 hours during the surgery.
12006666|NCT00542529|Biological|Imprime PGG TM for Injection|Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days
12006667|NCT00542516|Drug|Hydroxyethyl Starch|Dosage: 30ml/kg; frequency: one time; duration: 60min
12006668|NCT00542516|Drug|Ringer's lactate|Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups
12006669|NCT00542490|Radiation|Vaginal Cuff Brachytherapy|Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
12006670|NCT00542464|Biological|Imprime PGG TM for Injection|Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
12006671|NCT00542451|Drug|Paclitaxel|Every week for 12 weeks
12006672|NCT00542451|Drug|Trastuzumab|Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks
12006673|NCT00542438|Behavioral|Physical Activity Recall|Hand-held computers will be used to record information for 7 days about physical activity. Assessments will be completed either 3 times a day or once a day.
12006674|NCT00542438|Behavioral|Environmental Assessments|Hand-held computer programs will be used to collect information about the community. Some factors will be assessed only once (e.g., availability of facilities) while other information will be collected over the course of 7 days (e.g., perceptions of neighborhood safety).
12006675|NCT00542425|Drug|teriparatide|teriparatide 20 µg subcutaneous daily
12006676|NCT00542425|Drug|Placebo|Placebo subcutaneous daily
12006677|NCT00542425|Drug|BA058 20 µg|BA058 20 µg subcutaneous daily
12006678|NCT00542425|Drug|BA058 40 µg|BA058 40 µg subcutaneous daily
12006679|NCT00542425|Drug|BA058 80 µg|BA058 80 µg subcutaneous daily
12006680|NCT00542412|Drug|Riluzole|
12006681|NCT00542399|Drug|Levemir (insulin detemir)|Levemir once a day
12006682|NCT00542399|Drug|Levemir twice a day|Levemir twice a day
12006683|NCT00542386|Drug|MCI-196|3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
12006684|NCT00542386|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
12006685|NCT00542373|Other|Cytology Specimen Collection Procedure|Undergo oral tissue collection
12006686|NCT00542373|Procedure|Diagnostic Microscopy|Mouth tissue examined microscopically for cytologic features
12006687|NCT00542373|Procedure|Diagnostic Procedure|Undergo standard white light headlamp oral examination
12006688|NCT00542373|Procedure|Fluorescence Imaging|Undergo widefield fluorescent and reflectance imaging
12006689|NCT00542373|Procedure|Fluorescence Spectroscopy|Undergo point fluorescent spectroscopy
12006690|NCT00542360|Behavioral|Marketing program to motivate exercise class participation|Using qualitative research methods, a targeted social marketing program, including a 'marketing toolkit,' was developed to motivate participation in exercise classes by older adult members of churches. The Health Belief and Transtheoretical Models formed the theoretical basis for the social marketing planning process and guided program design. The marketing program aimed to increase exercise class attractiveness, usability, and uptake by reducing barriers and costs, and using messaging about benefits and enhanced convenience to motivate participation. The intervention was implemented through churches.
12006691|NCT00542347|Drug|Esomeprazole first|"esomeprazole 20mg po once per day for 7 days
~24hr pH study on day 7
~followed by washout for 7 days
~generic omeprazole 20mg po once per day for 7 days
~24hr pH study on day 7"
12006692|NCT00542347|Drug|Generic omeprazole first|"generic omeprazole 20mg po once per day for 7 days
~24hr pH study on day 7
~followed by washout for 7 days
~esomeprazole 20mg po once per day for 7 days
~24hr pH study on day 7"
12006693|NCT00542321|Other|Manual turn|Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
12006694|NCT00542321|Device|kinetic therapy bed|Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation
12006695|NCT00542308|Drug|Zalutumumab|Individual dose titration weekly i.v. doses
12006696|NCT00542295|Drug|alverine citrate and simeticone|
12006697|NCT00542295|Drug|placebo|
12006698|NCT00542269|Drug|Amlodipine|amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
12006699|NCT00542269|Drug|Aliskiren|aliskiren 150-300 mg tablets. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
12006700|NCT00542269|Drug|Ramipril|ramipril 5-10 mg capsules. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
12006701|NCT00542256|Device|Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy|14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.
12006702|NCT00542256|Device|Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy|14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.
12006703|NCT00542243|Drug|Finasteride|Finasteride (5mg) will be given once per day for 6 months.
12006704|NCT00542243|Drug|Placebo|Placebo will be given once a day for 6 months.
12006705|NCT00542217|Biological|Imprime PGG|
12006706|NCT00542204|Behavioral|Online disease management|The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.
12006707|NCT00542191|Drug|Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin|DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks
12006708|NCT00542191|Procedure|Definitive Surgery|Standard of care definitive surgery as determined by medical provider
12006870|NCT00541047|Procedure|quality-of-life assessment|
12006709|NCT00542191|Radiation|Radiotherapy|Standard of care RADIATION THERAPY as indicated
12006710|NCT00542178|Drug|Hypoglycemic Agents|Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
12006711|NCT00542178|Drug|Standard glycemia control|A strategy of glycemia drugs for HbA1c 7% - 7.9%
12006712|NCT00542178|Drug|Intensive BP treatment|A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
12006713|NCT00542178|Drug|Standard BP control|A strategy of BP drugs for SBP less than 140 mm Hg
12006714|NCT00542178|Drug|Fenofibrate|Blinded fenofibrate
12006715|NCT00542178|Drug|Simvastatin|Simvastatin 20-40 mg/d
12006716|NCT00542178|Drug|Placebo|Placebo
12006717|NCT00542165|Drug|Alfuzosin|
12006718|NCT00542152|Drug|CYCLOSPORINE VS INFLIXIMAB|"Cyclosporine 2mg/kg/day intravenous for 7 days then Neoral 4mg/kg/day orally for 3 months.
~Infliximab 5mg/kg at weeks 0, 2 and 6"
12006719|NCT00542139|Drug|Betamethasone|Intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate)
12006720|NCT00542139|Drug|Bupivocaine|Intraarticular injection of 10ml of Bupivocaine
12006721|NCT00542126|Drug|Decapeptyl 0.1 mg after embryo transfer|Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer
12006722|NCT00542113|Behavioral|DvtProgram ENERGY|11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
12006723|NCT00542113|Behavioral|DvtProgram ENERGY|6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
12006724|NCT00542113|Behavioral|DvtProgramENERGY|Children participating in Program ENERGY but no newsletters or family challenges sent home to parents
12006725|NCT00542100|Device|PCMRI|
12006726|NCT00542087|Drug|MK0663, etoricoxib / Duration of Treatment: 6 Weeks|
12006727|NCT00542087|Drug|Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks|
12006728|NCT00542074|Other|hygienic information plus 62% ethyl alcohol in emollient gel|The male partner in each couple was asked to apply Purell® to his penis at least daily, and immediately prior to and following intercourse. Couples received a brochure with information on control of STI and good hygienic practices. Brochures for intervention and control arms were similar except the intervention arm brochure provided information on how to use the study product (Purell®).
12006729|NCT00542074|Other|hygienic information|Couples received a brochure with information on control of STI and good hygienic practices.
12006730|NCT00542061|Device|half-yearly monitoring routine|A written expert advice for GPs on additional diagnostic, treatment, and referral of patients with asthma and COPD based on half-yearly monitoring routines (lung function assessments including extensive anamnese) supported by half-yearly visits of an AC nurse consultant to the general practices.
12006731|NCT00542048|Drug|EndoTAG®-1|EndoTAG®-1 22 mg/m² twice weekly
12006732|NCT00542035|Drug|ARRY-371797, p38 inhibitor; oral|dose 1, dose 2
12006733|NCT00542035|Drug|Placebo; oral|dose 1, dose 2
12006734|NCT00542035|Drug|Placebo; oral|dose 1
12006735|NCT00542035|Drug|ARRY-371797, p38 inhibitor; oral|dose 2
12006736|NCT00542022|Drug|MK0812 / Duration of Treatment: 12 Weeks|
12006737|NCT00542022|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks|
12006738|NCT00542009|Drug|CE-326,597 100 mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
12006739|NCT00542009|Drug|CE-326,597 50 mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
12006740|NCT00542009|Drug|CE-326,597 25 mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
12006741|NCT00542009|Drug|Placebo|Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
12006742|NCT00542009|Drug|CE-326,597 5mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
12006743|NCT00541996|Drug|vabicaserin|
12006744|NCT00541983|Drug|XOMA 052|Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.
12006745|NCT00541983|Drug|Placebo|Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.
12006746|NCT00541970|Biological|Cervarix|Intramuscular injection, different dosing /schedule
12006747|NCT00541970|Drug|Placebo|Intramuscular injection, different dosing /schedule
12006748|NCT00541957|Behavioral|behavior therapy|10 sessions over 4 months
12006749|NCT00541957|Drug|Medication prescribed by PCP|Can include any antidepressant medication
12006750|NCT00541931|Drug|Dietary Supplement: LifePak Nano|Daily use
12006751|NCT00541918|Drug|Diprivan (propofol, Astra Zeneca)|Total intravenous anesthesia with propofol
12006752|NCT00541918|Drug|Sevorane (sevoflurane, Abbott)|inhaled anesthesia with sevoflurane
12006753|NCT00541905|Drug|NT 201|Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session.
12006754|NCT00541892|Other|Medium with no human serum albumine added|See above
12006755|NCT00541892|Other|Conventional medium|See above
12006756|NCT00541879|Behavioral|Program ENERGY|Weekly or biweekly classroom and gym based science enrichment focused on how the body works including blood glucose regulation, healthy eating and physical activity, diabetes abd how it can be prevented
12006757|NCT00541879|Other|comparison|
12006758|NCT00541866|Drug|Voreloxin injection and cytarabine|"Dose-escalation Phase
~Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion of 400 mg/m2/day × 5 days)
~Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
~Expansion Phase The MTD determined in the dose-escalation phase was used in the expansion phase.
~Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
~Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)"
12006759|NCT00541853|Drug|Candesartan|Candesartan upto 8mg
12006760|NCT00541853|Drug|Candesartan and Cilnidipine|Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
12006761|NCT00541853|Drug|Candesartan plus non-CCB agents|Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI
12006762|NCT00541840|Drug|Sorafenib|"Phase I:
~Level 1: Sorafenib 200 mg bid, orally Ifosfamide 2,0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
~Level 2: Sorafenib 400 mg bid, orally Ifosfamide 2.00 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
~Level 3 : Sorafenib 400mg bid, orally Ifosfamide 2.5 g/m2 , intravenously , over 4 hours , on 3 consecutive days . Mesna 500mg/m2,iv,at 0,4 and 8 hours after ifosfamide administration .
~Level 4 : Sorafenib 400 mg bid, orally Ifosfamide 3.0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 600 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
~Phase II:
~Sorafenib and Ifosfamide administered at the doses recommended in phase I until progression or unacceptable toxicity."
12006763|NCT00541814|Drug|Cyclosporine|Target drug level 50-100 ng/ml or cyclosporine withdrawal
12006764|NCT00541801|Device|Doppler-echocardiography and acoustic cardiography|Patients receive a Doppler-echocardiography and an acoustic cardiography
12006765|NCT00541788|Other|Administration of Common Sage|Administration of Common Sage
12006766|NCT00541775|Drug|Sitagliptin|Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
12006767|NCT00541775|Drug|Comparator: Rosiglitazone|Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
12006768|NCT00541775|Drug|Comparator: Placebo|placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
12006769|NCT00541775|Drug|Comparator: Metformin|Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.
12006770|NCT00541762|Dietary Supplement|Fat perfusion to the small intestine|"Triglycerides, long chain fatty acids, medium chain fatty acids perfused to the small intestine
~Orlistat perfused to the small intestine
~DEXLOX as CCK-1 receptor antagonist"
12006771|NCT00541749|Drug|rhuMAb IFNalpha|Intravenous repeating dose
12006772|NCT00541736|Drug|Nitroglycerine|Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
12006773|NCT00541723|Drug|IncobotulinumtoxinA (Xeomin)|Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)
12006774|NCT00541723|Drug|Placebo|Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
12006775|NCT00541710|Dietary Supplement|genistein|pills of 27 mg, twice per day for 12 months
12006776|NCT00541710|Dietary Supplement|placebo|sugar pills twice per day for 12 months
12006777|NCT00541697|Drug|MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks|
12006778|NCT00541697|Drug|Comparator: atorvastatin / Duration of Treatment: 6 Weeks|
12006779|NCT00541684|Drug|MK0954, /Duration of Treatment : 16 Weeks|
12006780|NCT00541684|Drug|Comparator : atenolol /Duration of Treatment : 16 Weeks|
12006781|NCT00541671|Drug|Saline|10 c of saline
12006782|NCT00541671|Drug|Phenergan|Physician ordered dose
12006783|NCT00541658|Drug|risedronate|5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
12006784|NCT00541658|Drug|risedronate|35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
12006785|NCT00541658|Drug|risedronate|35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
12006786|NCT00541606|Other|Pharmacist collaboration in diabetes care|Patients attended a minimum of 3 clinic visits (month 0, 6, 12) with one of the clinical pharmacists, where targeted physical assessment, education, and medication changes and follow up were recommended. Additional visits were arranged as clinically appropriate for drug monitoring. Referrals were facilitated to other clinicians where indicated, including ophthalmology, podiatry, CDEs, nutrition, and primary care. The pharmacists' recommendations for medication adjustment, laboratory monitoring and referrals were based upon the most recent guidelines and clinical trial evidence. Any therapy adjustment, lab testing or referrals required approval by the referring physician. A1c, lipid and BP values were collected prospectively at months 0, 6 and 12.
12006787|NCT00541606|Other|Usual care|Control patients received usual care directed by their physician, and the same data were gathered from chart review during the 12-month study period.
12006788|NCT00541593|Procedure|Pancreatic Pseudocystgastrostomy|An operation to connect the pancreatic pseudocyst to the stomach so it can drain into the stomach and intestines
12006789|NCT00541567|Drug|ibipinabant|oral, tablet, once daily
12006790|NCT00541554|Drug|Abilify (aripiprazole)|
12006791|NCT00541541|Procedure|Phrenic nerve stimulation|Patients receive a phrenic nerve stimulation
12006792|NCT00541515|Device|continuous glucose sensors and insulin pump|continuous glucose sensors and insulin pump
12006793|NCT00541489|Drug|Naproxcinod|750 mg, bid
12006794|NCT00541489|Drug|Naproxen|500 mg, bid
12006795|NCT00541489|Drug|Placebo|bid
12006796|NCT00541463|Drug|MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks|
12006797|NCT00541463|Drug|Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks|
12006798|NCT00541450|Drug|Comparator: sitagliptin phosphate (sitagliptin)|sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period
12006799|NCT00541450|Drug|sitagliptin phosphate (+) metformin hydrochloride|sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period
12006800|NCT00541450|Drug|Comparator: pioglitazone|pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.
12006801|NCT00541450|Drug|Matching placebo to pioglitazone|"matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.
~Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks."
12006802|NCT00541450|Drug|Matching placebo to sitagliptin|matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.
12006871|NCT00541047|Radiation|radiation therapy|
12006872|NCT00541034|Biological|rituximab|
12006803|NCT00541450|Drug|Matching Placebo to Sita/Met FDC|matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).
12006804|NCT00541424|Procedure|PET/CT Scanning|Full-body PET/CT procedure will be performed. Gas will be pumped into the colon before the scan so the colon will be opened up (inflated) and the study doctor will be able to more easily look for any lesions. This procedure is called gas insufflation.
12006805|NCT00541411|Drug|Vincristine, Actinomycin-D, Ifosfamide|Chemotherapy
12006806|NCT00541398|Behavioral|Implementation of guideline|Outreach visits with interactive education for health staff
12006807|NCT00541385|Drug|pyronaridine artesunate|The strength of the granule formulation is 60:20 mg pyronaridine artesunate per sachet. Depending on their body weight, patients will receive between 1 to 3 pyronaridine artesunate sachets per day, for 3 consecutive days The actual dose-range covered by this regimen is 7.0:2.3 mg/kg to 13.3:4.4 mg/kg pyronaridine artesunate, which has shown to be effective and safe in the phase II studies conducted in children and adults.
12006808|NCT00541385|Drug|arthemeter lumefantrine|"Artemether 20 mg and lumefantrine 120 mg fixed dose combination, 6 dose regimen 120 mg artemether and 720 mg lumefantrine total (Novartis).
~The posology is twice daily for 3 consecutive days 1 tablet for patients weighing ≥5 kg to <15 kg, 2 tablets for patients weighing ≥15 to <25 kg."
12006809|NCT00541372|Device|insulin injection needle size|The intervention in this study is a specific needle with a length of 5 mm and 8 mm to be used with an insulin pen.
12006810|NCT00541359|Drug|bortezomib|Given IV
12006811|NCT00541359|Drug|topotecan hydrochloride|Given IV
12006812|NCT00541359|Other|immunohistochemistry staining method|Correlative studies
12006813|NCT00541359|Other|pharmacological study|Correlative studies
12006814|NCT00541346|Drug|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage
12006815|NCT00541333|Drug|Copaxone Injection|
12006816|NCT00541320|Drug|GW813893|
12006817|NCT00541307|Device|Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface|Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
12006818|NCT00541281|Drug|docetaxel|35mg/m² on day 2 and 9 (21days in a cycle)
12006819|NCT00541281|Drug|estramustine|140mg caps x3 bid from day 1to 5 and day 8 to 12 of each cycle
12006820|NCT00541281|Drug|prednisone|2x5 mg a day
12006821|NCT00541268|Device|ICD|Intracardioverter defibrillators from 2 different manufacturers
12006822|NCT00541268|Other|Optimal medical treatment|ACEi or angiotensin receptor blockers Betablockers Aldosterone blockers
12006823|NCT00541242|Drug|bimatoprost 0.03% eye drops|Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
12006824|NCT00541242|Drug|latanoprost 0.005% eye drops|Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
12006825|NCT00541229|Drug|sitagliptin phosphate|sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
12006826|NCT00541229|Drug|sitagliptin phosphate|sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
12006827|NCT00541229|Drug|Comparator: Placebo|sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
12006828|NCT00541216|Drug|Ephedrine|
12006829|NCT00541190|Other|Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA|Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.
12006830|NCT00541177|Drug|atropine|0.25% atropine
12006831|NCT00541177|Drug|tropicamide|0.5% tropicamide
12006832|NCT00541164|Drug|Coenzyme Q10|300 mg CoQ10 twice a day for 48 weeks
12006833|NCT00541164|Dietary Supplement|Coenzyme Q10|300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study
12006834|NCT00541151|Device|MiniArc|sling system
12006835|NCT00541138|Drug|carboplatin|CBDCA AUC=3
12006836|NCT00541138|Drug|tamoxifen citrate|Tamoxifen 100mg bid
12006837|NCT00541138|Drug|topotecan hydrochloride|Topotecan 0.75 g/m2/d
12006838|NCT00541138|Other|pharmacological study|Start of tx, hours 24,28 and 72 during Topotecan infusion, and hours 1,2,4 and 6 after end of Topotecan infusion.
12006839|NCT00541125|Biological|bevacizumab|
12006840|NCT00541125|Biological|filgrastim|
12006841|NCT00541125|Drug|fluorouracil|
12006842|NCT00541125|Drug|irinotecan hydrochloride|
12006843|NCT00541125|Drug|leucovorin calcium|
12006844|NCT00541112|Biological|cetuximab|
12006845|NCT00541112|Drug|capecitabine|
12006846|NCT00541112|Drug|fluorouracil|
12006847|NCT00541112|Drug|leucovorin calcium|
12006848|NCT00541112|Drug|oxaliplatin|
12006849|NCT00541112|Procedure|adjuvant therapy|
12006850|NCT00541112|Procedure|conventional surgery|
12006851|NCT00541112|Procedure|neoadjuvant therapy|
12006852|NCT00541112|Radiation|radiation therapy|
12006853|NCT00541099|Biological|bevacizumab|Avastin 10.0 mg/kg on days 1 and 15
12006854|NCT00541099|Drug|docetaxel|Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
12006855|NCT00541086|Drug|anastrozole|1 mg per day, orally
12006856|NCT00541086|Drug|exemestane|25 mg per day, orally
12006857|NCT00541086|Drug|letrozole|2.5 mg per day, orally
12006858|NCT00541086|Drug|tamoxifen citrate|20 mg per day, orally
12006859|NCT00541073|Dietary Supplement|vitamin B12|
12006860|NCT00541073|Drug|cisplatin|
12006861|NCT00541073|Drug|pemetrexed disodium|
12006862|NCT00541073|Genetic|gene expression analysis|
12006863|NCT00541073|Other|laboratory biomarker analysis|
12006864|NCT00541073|Other|pharmacological study|
12006865|NCT00541060|Genetic|mutation|a mutation of a gene coding
12006866|NCT00541047|Drug|bicalutamide|
12006867|NCT00541047|Drug|goserelin acetate|
12006868|NCT00541047|Drug|leuprolide acetate|
12006869|NCT00541047|Procedure|adjuvant therapy|
12006875|NCT00541021|Drug|gemcitabine hydrochloride|
12006876|NCT00541021|Drug|sorafenib tosylate|
12006877|NCT00541008|Drug|sunitinib malate|
12006878|NCT00540995|Drug|busulfan|Given IV
12006879|NCT00540995|Drug|etoposide|Given IV
12006880|NCT00540995|Radiation|intensity-modulated radiation therapy|Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
12006881|NCT00540995|Procedure|allogeneic hematopoietic stem cell transplantation|Stem cell transplantation occurs on Day 0 after High Dose Therapy
12006882|NCT00540995|Procedure|allogeneic bone marrow transplantation|Stem cell transplantation occurs on Day 0 after High Dose Therapy
12006883|NCT00540995|Procedure|peripheral blood stem cell transplantation|Stem cell transplantation occurs on Day 0 after High Dose Therapy
12006884|NCT00540995|Radiation|tomotherapy|Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
12006885|NCT00540982|Drug|indocyanine green|0.5 mg/kg will be administered by IV push to determine clearance
12006886|NCT00540982|Drug|lidocaine|1 mg/kg will be administered to determine metabolic capacity
12006887|NCT00540982|Drug|vinorelbine ditartrate|Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
12006888|NCT00540982|Other|high performance liquid chromatography|Used to determine plasma concentrations of vinorelbine
12006889|NCT00540982|Other|intracellular fluorescence polarization analysis|Used to determine concentration of lidocaine metabolic capacity
12006890|NCT00540982|Other|liquid chromatography|Used to determine concentrations of vinorelbine and its metabolites
12006891|NCT00540982|Other|mass spectrometry|Used to determine concentrations of vinorelbine and its metabolites
12006892|NCT00540982|Other|pharmacological study|Determination of concentrations of vinorelbine and its metabolites
12006893|NCT00540969|Procedure|cryosurgery|Patients undergo cryosurgery using guidance from CT scan or ultrasound
12006894|NCT00540969|Radiation|radiation therapy|Patients undergo radiotherapy for 1 week
12006895|NCT00540956|Drug|cytarabine|
12006896|NCT00540956|Other|laboratory biomarker analysis|
12006897|NCT00540943|Drug|Pazopanib|Pazopanib is a potent, multi-targeted tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit.
12006898|NCT00540943|Drug|Cetuximab|"Cetuximab will be supplied as a single-use 50 milliliter vial containing 100 micrograms of cetuximab as a sterile, preservative-free, injectable liquid at a concentration of 2 milligram per milliliter in phosphate.
~buffered saline"
12006899|NCT00540943|Drug|Irinotecan|Irinotecan hydrochloride trihydrate is an antineoplastic agent of the topoisomerase I inhibitor class.
12006900|NCT00540930|Drug|Ranibizumab|Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion
12006901|NCT00540917|Procedure|cooling spray during laser treatment|skin temperature measurement
12006902|NCT00540904|Drug|sodium bicarbonate|IV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.
12006903|NCT00540904|Drug|NaCl|IV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.
12006904|NCT00540891|Drug|ALFUZOSIN|
12006905|NCT00540878|Drug|SB-751689 oral tablets (400 mg)|
12006906|NCT00540865|Behavioral|Problem-solving therapy (PST)|The premise of PST is that psychotherapies implicitly help people to become better managers of their lives, in effect, to become better at solving problems. Unlike Case Management (CM) that seeks to increase its clients' availability and utilization of resources, PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment. Although CM and PST have different theoretical premises, they both focus on the resolution of concrete problems promoting depression.
12006907|NCT00540865|Behavioral|Case management (CM)|Different types of CM exist, but all share the theme of helping individuals cope with their illnesses through linkage to social services, advocacy, rehabilitation, and ongoing support during recovery from illnesses. CM will consist of the following components: 1) socialization to treatment; 2) needs assessment; 3) psychoeducation about depression; 4) service planning; 5) linkage to social services; 6) help with access to health care; 7) advocacy; and 8) exploration of barriers that perpetuate unmet needs.
12006908|NCT00540852|Device|Diffuse Optical Spectroscopy Imaging|Diffuse Optical Spectroscopy Imaging
12006909|NCT00540839|Drug|Montelukast sodium|Montelukast 4 mg OG or montelukast 4 mg CT
12006910|NCT00540839|Drug|Placebo to montelukast|Placebo OG or CT
12006911|NCT00540839|Drug|Fluticasone propionate|Fluticasone 50 mcg inhalation aerosol metered dose inhaler
12006912|NCT00540839|Drug|Placebo to fluticasone|Placebo inhalation aerosol metered dose inhaler
12006913|NCT00540826|Drug|Atomoxetine|in-label use
12006914|NCT00540826|Drug|stimulants (any approved ADHD medication)|in-label use
12006915|NCT00540813|Device|drug eluting balloon|drug eluting balloon bifurcated coronary lesions single arm study
12006916|NCT00540800|Drug|docetaxel|given in combination with epirubicin or capecitabine
12006917|NCT00540800|Drug|epirubicin|for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines
12006918|NCT00540800|Drug|capecitabine|for metastatic breast cancer patients previously treated with anthracyclines
12006919|NCT00540787|Device|Radiofrequency ablation, antiarrhythmic drugs|Patients receive either treatment.
12006920|NCT00540787|Drug|Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs|Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week.
12006921|NCT00540787|Device|ThermoCool Radiofrequency Catheter|Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.
12006922|NCT00540774|Device|detection of oral pathology|detection of oral pathology
12006923|NCT00540761|Device|OFDI imaging|Intervention of OFDI system and Imaging of the culprit lesion using the OFDI system.
12006924|NCT00540748|Drug|oxytocin|5 U i.v. during surgical abortion
12006925|NCT00540735|Procedure|photodynamic therapy|
12006926|NCT00540722|Drug|R-(-)-gossypol acetic acid|Given PO
12006927|NCT00540722|Other|laboratory biomarker analysis|Correlative studies
12006929|NCT00540696|Drug|darbepoetin alfa|"Darbepoetin alfa 3.0mcg/kg every 2 weeks for 3 doses. At week 7, if the subject has not experienced an increase of at least 1.0g/dL in hgb from week 1, increase dose of darbepoetin alfa to 5.0mcg/kg every 2 weeks for 5 doses.
~Otherwise, maintain darbepoetin alfa 3.0mcg/kg every 2 weeks for 5 doses."
12006930|NCT00540683|Device|Diffuse Optical Spectroscopy|Muscle properties
12006931|NCT00540670|Drug|E5555 50 mg|E5555 50 mg (tablet) taken orally, once a day.
12006932|NCT00540670|Drug|E5555 100 mg|E5555 100 mg (tablet) taken orally, once a day.
12006933|NCT00540670|Drug|E5555 200 mg|E5555 200 mg (tablet) taken orally, once a day.
12006934|NCT00540670|Drug|Placebo|Placebo (tablet) taken orally, once a day.
12006935|NCT00540657|Drug|CCX282-B|250mg capsule, twice daily, 13 weeks
12006936|NCT00540657|Drug|Placebo|Placebo capsule, twice daily, 13 weeks
12006937|NCT00540644|Drug|lenalidomide (Revlimid®)|25 mg p.o. daily on days 1-21 of each 28 day cycle
12006938|NCT00540644|Drug|Cyclophosphamide|50 mg p.o. BID daily on days 1-21 of each 28 day cycle
12006939|NCT00540644|Drug|Prednisone|50 mg p.o. Q.O.D.
12006940|NCT00540631|Biological|specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)|"Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
~to be det. A 0.1 100 TU
~7 (+7) days later A 0.2 200 TU
~7 (+7) days later A 0.4 400 TU
~7 (+7) days later A 0.6 600 TU
~7 (+7) days later B 0.1 1000 TU
~7 (+7) days later B 0.2 2000 TU
~7 (+7) days later B 0.4 4000 TU
~7 (+7) days later B 0.6 6000 TU
~Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
~to be det. A 0.1 100 TU
~7 (+7) days later A 0.2 200 TU
~7 (+7) days later A 0.4 400 TU
~7 (+7) days later A 0.6 600 TU
~7 (+7) days later B 0.1 1000 TU
~7 (+7) days later B 0.2 2000 TU
~7 (+7) days later B 0.4 4000 TU
~7 (+7) days later B 0.6 6000 TU
~Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued"
12006941|NCT00540618|Drug|MEDI-507|Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
12006942|NCT00540618|Other|Placebo|
12006943|NCT00540618|Drug|MEDI-507|Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)
12006944|NCT00540618|Drug|MEDI-507|Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)
12006945|NCT00540605|Drug|Tenofovir 1% vaginal gel|topical gel containing 1% tenofovir
12006946|NCT00540592|Biological|GlaxoSmithKline Biologicals' influenza vaccine GSK576389A|Single dose, Intramuscular injection, 8 different formulations were tested (one per group)
12006947|NCT00540592|Biological|Fluarix|Single dose, Intramuscular injection
12006948|NCT00540579|Drug|Pomalidomide|Phase 1: Subjects will be enrolled in dose-escalating cohorts to be treated with CC-4047 on days 1-21 Phase II: Subjects will be enrolled to receive oral CC-4047 at the MTD days 1 - 21
12006949|NCT00540579|Drug|Gemcitabine|1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle
12006950|NCT00540566|Device|Optical Biopsy imaging|Optical Biopsy imaging
12006951|NCT00540553|Drug|placebo|
12006952|NCT00540553|Drug|GSK971086|
12006953|NCT00540540|Device|Diffuse Optical Spectroscopy|Breast properties scanning
12006954|NCT00540527|Drug|local interarterial recombinant tissue plasminogen activator|Endovascular treatment must be performed asap after random.and definitely within 6h from symp. onset.It includes intrarterial thrombolysis with rt-PA,if necessary,associated to or substituted by mechanical clot disruption and/or retrieval.Fibrinolytic therapy should be performed within 1h,the full dose of rt-PA infusion should not exceed 0.9 mg/kg (max 90 mg in the case of body weight ≥100 kg).If a complete recanalization is achieved,rt-PA infusion can be interrupted before reaching the maximum dosage.The option of performing a thrombolysis by mechanical means to obtain a mechanical disintegration/shift/detach/fissure of the thrombus and/or a retraction/aspiration can be considered on the basis of the type,location and characteristics of the occlusion.These choices may involve the use of the microguidewire as a mechanical instrument to favour the disintegration of the thrombus,using systems to capture the thrombus by extraction or more complex systems to crush and aspirate the thrombus
12006955|NCT00540527|Drug|intravenous (IV) rt-PA|IV thrombolytic treatment is started immediately after randomization, within 4.5 h of symptoms onset. IV rt-PA is administered at a dose of 0.9 mg/kg (max 90 mg), 10% of which is given as a bolus, followed by the delivery of the remaining 90% as a constant infusion over 60 mins
12006956|NCT00540514|Drug|Albumin-bound paclitaxel|Administered by intravenous infusion.
12006957|NCT00540514|Drug|Paclitaxel|Administered by intravenous infusion.
12006958|NCT00540514|Drug|Carboplatin|Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate [GFR] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).
12006959|NCT00540501|Drug|Oseltamivir and Intravenous Zanamivir|"Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.
~Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.
~Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes."
12006960|NCT00540488|Other|Adult enteral formula|
12006961|NCT00540462|Procedure|gastric bypass|
12006962|NCT00540462|Procedure|sleeve gastrectomy|
12006963|NCT00540449|Drug|TMC278|25 mg tablet once daily for 96 weeks
12006964|NCT00540449|Drug|Efavirenz|600mg once daily for 96 weeks
12006965|NCT00540436|Drug|GSK1325760A|Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.
12006966|NCT00540423|Drug|SB-497115-GR 12.5mg|SB-497115-GR 12.5mg tablet once a day
12006967|NCT00540423|Drug|SB-497115-GR 25mg|SB-497115-GR 25mg tablet once a day
12006968|NCT00540423|Drug|SB-497115-GR 12.5mg matching placebo|SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day
12006969|NCT00540423|Drug|SB-497115-GR 50 mg|SB-497115-GR 25mg tablet x2 once a day
12006970|NCT00540410|Drug|Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)|Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
12007314|NCT00537810|Drug|Sibutramine|15 mg daily
12006971|NCT00540410|Drug|Coartem® (arthemether+ lumefantrine)|"Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range.
~Duration of treatment: 3 days"
12006972|NCT00540397|Drug|Fuzhenghuayu Tablet, Huangqi Decoction Granule|
12006973|NCT00540384|Drug|Placebo|Placebo
12006974|NCT00540384|Drug|Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)|Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
12006975|NCT00540371|Other|Port wine stain Birthmark|Port wine stain Birthmark
12006976|NCT00540358|Drug|gemcitabine/carboplatin|Gemcitabine and carboplatin administered according to instructions in the package inserts.
12006977|NCT00540358|Drug|iniparib|"Body weight adjusted dose
~1 hour intravenous infusion"
12006978|NCT00540345|Drug|pegylated interferon alpha 2a and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 4 weeks followed by pegylated interferon alpha 2a 180 mcg/week and Ribavirin 800 mg/day for 12 weeks, follow up for 24 weeks
12006979|NCT00540345|Drug|Pegylated interferon alfa-2a and ribavirin|pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 16 weeks, follow up for 24 weeks
12006980|NCT00540345|Drug|pegylated interferon alpha 2a and ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
12006981|NCT00540345|Drug|pegylated interferon alpha 2a and ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 48 weeks, follow up for 24 weeks
12006982|NCT00540332|Drug|Placebo|Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.
12006983|NCT00540332|Drug|palifermin|120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course
12006984|NCT00540319|Behavioral|HIP|"The Health in Pregnancy (HIP) computer program provides tailored, interactive Video Doctor counseling about behavioral risks, educational worksheets for the patients, and a cueing sheet for providers."
12006985|NCT00540306|Device|Diffuse Optical Spectroscopy|Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy
12006986|NCT00540293|Drug|Atorvastatin|Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
12006987|NCT00540280|Radiation|Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin|Surgery + Chemo + RT
12006988|NCT00540267|Other|No Intervention|No Intervention
12006989|NCT00540254|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems
12006990|NCT00540254|Other|Usual Care for Chronic Fatigue Syndrome (Active Control Group)|Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs
12006991|NCT00540241|Drug|Pemetrexed|in-label use
12006992|NCT00540228|Biological|Influenza Vaccine GSK1247446A - 4 different formulations|Single dose, Intramuscular injection
12006993|NCT00540228|Biological|Fluarix™|Single dose, Intramuscular injection
12006994|NCT00540215|Other|Glucagonlike peptide|450 nmol native form, synthetic
12006995|NCT00540202|Drug|artemether-lumefantrine|Tablets taken twice daily for 3 days according to weight based guidelines.
12006996|NCT00540202|Drug|Oral quinine|Quinine tablets given at 10mg/kg 8 hourly for 7 days
12006997|NCT00540189|Procedure|Initial appendectomy|
12006998|NCT00540189|Procedure|Interval appendectomy|
12006999|NCT00540176|Drug|Dichloroacetate (DCA)|Oral DCA given twice daily for the 24 week period of the study. Continuation of therapy will be indefinite if efficacious.
12007000|NCT00540150|Biological|specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)|We treat each patient with mite-allergen following the two different protocols.
12007001|NCT00540137|Drug|nevirapine|400mg once daily
12007002|NCT00540137|Drug|atazanavir/ritonavir|atazanavir 300 mg once daily ritonavir 100 mg once daily
12007003|NCT00540124|Drug|Tadalafil|5 mg once a day
12007004|NCT00540124|Drug|Placebo|once a day
12007005|NCT00540124|Drug|Tamsulosin|0.2 mg once a day
12007006|NCT00540111|Dietary Supplement|soluble fiber® (partially hydrolyzed guar gum)|HIV-positive individuals with hypertriglyceridemia and who had been on the same HAART regimen for at least 6 months, had no change in therapy during the study,received 20g/day of soluble fiber for 4 months at pre-established times.
12007007|NCT00540098|Drug|paroxetine + aerobic exercise|paroxetine, 40 mg once daily + regular aerobic exercise
12007008|NCT00540098|Drug|Paroxetine + relaxation|paroxetine, 40 mg once daily + regular relaxation training
12007009|NCT00540098|Drug|Placebo + aerobic exercise|placebo pill once daily + regular aerobic exercise
12007010|NCT00540098|Drug|Placebo + relaxation|placebo pill once daily + regular relaxation training
12007011|NCT00540085|Drug|Rocuronium|0.6 mg/kg given intravenously before intubation
12007012|NCT00540072|Drug|daptomycin|
12007013|NCT00540046|Device|Copper T 380A IUD|Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
12007014|NCT00540033|Dietary Supplement|infloran|Study group was fed with probiotics as infloran 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;
12007015|NCT00540033|Dietary Supplement|infloran|Study group was fed with infloran [Lactobacilli acidophilus (CFU 109 NCDO 1748, obtained from the National Collection of Dairy Organisms)] and Bifidobacteria bifidum [(CFU 109, NCDO 1453 obtained from the National Collection of Dairy Organisms)]; Laboratorio Farmaceutico S.I.T S.r.I ITALY] 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;
12007016|NCT00540020|Other|Rehabilitation|
12007017|NCT00540007|Drug|Lenalidomide|
12007018|NCT00539994|Drug|retapamulin|200mg BID retapamulin 3 days
12007019|NCT00539994|Drug|Retapamulin|200mg BID retapamulin 5 days
12007020|NCT00539994|Drug|Placebo|200mg BID placebo 5 days
12007021|NCT00539981|Biological|Influenza Vaccine, recombinant hemagglutinin, FluBlok|0.5mL dose for IM injection
12007022|NCT00539968|Drug|Docetaxel plus lonafarnib|"Docetaxel: 60-75 mg/m2
~Lonafarnib: 150-375 mg PO BID"
12007023|NCT00539955|Behavioral|Standard Batterer Intervention|Standard state-mandated batterer intervention program (40 hours)
12007024|NCT00539955|Behavioral|Brief Alcohol Intervention|Brief alcohol intervention combined with state mandated batterer intervention program
12007025|NCT00539942|Drug|Arixtra (fondaparinux sodium)|Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.
12007026|NCT00539942|Device|Intermittent compression devices (ICD)|All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
12007027|NCT00539929|Drug|E6201 0.005%|
12007028|NCT00539929|Drug|E6201 0.01%|
12007029|NCT00539929|Drug|E6201 0.03%|
12007030|NCT00539929|Drug|Placebo|
12007031|NCT00539916|Behavioral|Regular orange juice consumption|600 mL /day.
12007032|NCT00539903|Behavioral|Physical activity (PA) and immigrants|
12007033|NCT00539890|Drug|Technosphere Insulin|
12007034|NCT00539877|Drug|irinotecan|"Postoperative day 1, IP CPT-11 chemotherapy will be given by CAPD catheter. CPT-11 in 1L of normal saline, prewarmed to 37°C will be given intraperitoneally.
~If there is no DLT and patients agree with the treatment, patients can receive 3 more times of IP chemotherapy with same dose of CPT-11 at 3 weeks interval. After total 4 cycles of IP chemotherapy, peritoneal disease will be reassessed with abdominal-pelvis CT. Pharmacokinetic study is not planned with this treatment."
12007035|NCT00539864|Biological|FluBlok Influenza Vaccination|0.5mL dose for intramuscular injection
12007036|NCT00539864|Biological|TIV (Fluzone) Influenza Vaccination|0.5mL dose for intramuscular injection
12007037|NCT00539838|Drug|Prednisone|Oral repeating dose
12007038|NCT00539838|Drug|Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)|Oral repeating dose
12007039|NCT00539838|Drug|Methylprednisolone|Intravenous repeating dose
12007040|NCT00539838|Drug|Ocrelizumab|Intravenous repeating dose
12007041|NCT00539838|Drug|Placebo|Intravenous repeating dose
12007042|NCT00539825|Drug|GSK704838|
12007043|NCT00539812|Behavioral|Standard Care|Standard 40 hour state mandated batterer intervention program
12007044|NCT00539812|Behavioral|Brief Alcohol Intervention combined with standard care|Brief alcohol intervention combined with standard 40 hour state mandated batterer intervention program
12007045|NCT00539799|Drug|prednisolone|5 - 7.5 mg/day
12007046|NCT00539799|Drug|Placebo|Matched placebo to prednisolone
12007047|NCT00539786|Drug|Proton pump inhibitor (rabeprazole)|Patients receives rabeprazole 20mg AM and 20mg PM for 14 days
12007048|NCT00539773|Drug|BCG, Interferon|Chemotherapy
12007049|NCT00539760|Drug|GSK1827771|GSK1827771 will be administered using injection via subcutaneous (SC) route.
12007050|NCT00539760|Drug|Placebo|Placebo to GSK1827771 for Injection will be administered via SC route
12007051|NCT00539734|Drug|ranibizumab|A single dose of 0.5 mg ranibizumab injected intravitreally.
12007052|NCT00539721|Drug|Rolapitant Dose 1|Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
12007053|NCT00539721|Drug|Rolapitant Dose 2|Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
12007054|NCT00539721|Drug|Rolapitant Dose 3|Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
12007055|NCT00539721|Drug|Rolapitant Dose 4|200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
12007056|NCT00539721|Drug|Ondansetron|Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1
12007057|NCT00539721|Drug|Placebo|Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
12007058|NCT00539708|Procedure|Non-invasive ventilation|Non-invasive ventilation after extubation for 24 hours
12007059|NCT00539695|Biological|IL-2|"IL2 Administration:
~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as 'week beginning with first IL-2 injection."
12007060|NCT00539669|Drug|Docetaxel|
12007061|NCT00539656|Biological|Ex vivo expansion of cord blood|Day 0: the expanded cell product will be infused to patient; Day +1: A second, unexpanded, cord blood product will be infused
12007062|NCT00539643|Device|Bead Block microspheres|Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
12007063|NCT00539643|Other|Bead + Dox Arm|Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
12007064|NCT00539630|Drug|Docetaxel|
12007065|NCT00539617|Drug|Erlotinib|Tarceva single agent therapy: 150 mg/day PO
12007066|NCT00539617|Drug|5-fluorouracil|5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks
12007067|NCT00539617|Drug|Leucovorin|400 mg/m2 IV once every 2 weeks for 16 weeks
12007068|NCT00539617|Drug|Oxaliplatin|85 mg/m2 IV once every 2 weeks for 16 weeks
12007069|NCT00539604|Procedure|MDCT and Coronary Angiography|
12007070|NCT00539591|Drug|Peginterferon alfa-2b|Given either IV or SQ. Therapeutic drug class: interferon.
12007071|NCT00539591|Drug|Temozolomide|Given PO. Therapeutic drug class: antineoplastic agent.
12007072|NCT00539591|Drug|Recombinant interferon alfa-2b|Given IV. Therapeutic drug classes: antineoplastic agent, immunomodulatory agent, interferon
12007073|NCT00539578|Drug|MK0777|Duration of Treatment: 4 weeks
12007074|NCT00539578|Drug|Comparator: placebo (unspecified)|Duration of Treatment: 4 weeks
12007075|NCT00539565|Drug|prednisolone|"2 mg/kg /day from post-op day 7 - day 21
~1 mg/kg /day from post-op day 22 - day 30"
12007076|NCT00539565|Drug|placebo|
12007315|NCT00537810|Drug|Placebo|Daily
12007077|NCT00539539|Other|Laerdal Q-CPR /technology|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
12007078|NCT00539526|Drug|Bimatoprost 0.03%|bimatoprost 0.03%, 1 drop nightly for 3 months
12007079|NCT00539526|Drug|travoprost 0.004%|travoprost 0.004% eye drops, 1 drop nightly for 3 months
12007080|NCT00539526|Drug|latanoprost 0.005% eye drops|latanoprost 0.005%, 1 drop nightly for 3 months
12007081|NCT00539513|Drug|N-Acetylcysteine|3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks
12007082|NCT00539513|Drug|placebo|placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks
12007083|NCT00539500|Drug|Carboplatin|Carboplatin by vein over 24 hours for 4 days, dosing as determined at day 1.
12007084|NCT00539500|Drug|Etoposide|300 mg/m^2 by vein over 24 hours for 4 days
12007085|NCT00539500|Drug|Melphalan|70 mg/m^2 Intravenous Bolus for 3 Days
12007086|NCT00539500|Procedure|Stem Cell Infusion|Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0.
12007087|NCT00539500|Device|ClinicMACS|Device used to process the blood and separate the CD 133+ cells needed for transplantation
12007088|NCT00539474|Procedure|Radio guided occult lesion localisation|ROLL procedure using the Europrobe (Europrobe, Strassbourg, France) WGL using a hook wire
12007089|NCT00539448|Drug|insulin glargine|in combination with insulin Glulisine as bolus regimen
12007090|NCT00539448|Drug|insulin glulisine|in combination with insulin Glargine as bolus regimen
12007091|NCT00539435|Procedure|Intravenous Insulin on cardiac disease in diabetic pts|Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
12007092|NCT00539422|Genetic|pcr and serum markers for breast cancer|DNA extraction and genotyping of cytochrome P450-2D6*4 gene using conventional PCR followed by restriction enzyme (Mva1) digestion. Separated plasma was used for measurement of plasma malondialdehyde(MDA)concentration, total plasma antioxidant capacity and plasma ferretin level.
12007093|NCT00539409|Procedure|Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)|Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
12007094|NCT00539396|Drug|Technosphere Insulin|
12007095|NCT00539383|Drug|ANG1005|IV infusion once every 21 days
12007096|NCT00539357|Device|Cranial electrotherapy stimulation (CES)|Cranial electrotherapy stimulation (CES) is a noninvasive procedure that involves applying a pulsed, low-amplitude electrical current to the head using electrodes placed on the earlobes. Cranial electrotherapy stimulation CES received U.S. Food and Drug Administration (FDA) approval for the treatment of insomnia, depression, and anxiety in 1979.
12007097|NCT00539344|Drug|ANG1005|IV infusion once every 21 days
12007098|NCT00539331|Drug|AZD2171|oral tablet
12007099|NCT00539331|Drug|Paclitaxel|intravenous infusion
12007100|NCT00539331|Drug|Carboplatin|intravenous injection
12007101|NCT00539318|Procedure|Blood drawing|Once when enroll in study
12007102|NCT00539305|Drug|testosterone gel|50-100mg applied topically daily for six months
12007103|NCT00539305|Drug|placebo gel|applied topically daily for six months
12007104|NCT00539292|Procedure|Primary placement of a spring-loaded silo|
12007105|NCT00539292|Procedure|Primary Closure|primary closure of abdomen
12007106|NCT00539279|Behavioral|Prolonged Exposure Therapy (PE)|PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
12007107|NCT00539279|Behavioral|Relaxation Training (RT)|RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
12007108|NCT00539266|Biological|bone marrow derived mononuclear cells|40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
12007109|NCT00539266|Biological|placebo|40 IM injections (calf muscle) of placebo suspension
12007110|NCT00539253|Drug|gadobenate dimeglumine (MultiHance)|The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
12007111|NCT00539240|Drug|Rabeprazole 20mg, placebo dinner and bedtime|Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
12007112|NCT00539240|Drug|Rabeprazole 20 mg two times, Placebo at bedtime|Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
12007113|NCT00539240|Drug|Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant|Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
12007114|NCT00539227|Procedure|NAC Sparing Mastectomy|A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC).
12007115|NCT00539227|Behavioral|Questionnaire|Questionnaires taking about 20-30 minutes to complete.
12007116|NCT00539201|Drug|GSK706769|
12007117|NCT00539188|Drug|N-Acetylcysteine|3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
12007118|NCT00539188|Drug|placebo|placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
12007119|NCT00539175|Device|infrared light|pulsed infrared light will be applied to feet, ankles and popliteal fossae of patients with diabetic neuropathy
12007120|NCT00539175|Device|infrared light; placebo|patients will be exposed to the same machine used to provide pulsed infrared light, but the light emitting diodes will not be activated. All other aspects of the treatment will be the same. The patient and investigator will be blind to treatment assignment.
12007121|NCT00539162|Behavioral|Questionnaire|Questionnaires completed at baseline and during each follow up visit.
12007122|NCT00539149|Drug|Amoxycillin|50 mg/kg/day twice daily
12007123|NCT00539149|Drug|Placebo equivalent to amoxycillin|50 mg/kg/d twice daily
12007124|NCT00539136|Drug|GSK561679 tablet or solution|
12007250|NCT00538213|Biological|Fluarix™|Single dose, Intramuscular injection
12007425|NCT00537121|Drug|leucovorin calcium|Given IV
12007125|NCT00539123|Behavioral|behavioral drug and HIV risk reduction counseling (BDRC)|BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in Malaysia.
12007126|NCT00539123|Behavioral|abstinence-contingent take-home buprenorphine (ACB)|Patients achieving heroin abstinence receive take-home doses of buprenorphine
12007127|NCT00539123|Behavioral|Physician Management (PM)|medically focused advice and brief counseling
12007128|NCT00539110|Drug|zolipidem|zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
12007129|NCT00539110|Drug|ramelteon|ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
12007130|NCT00539097|Dietary Supplement|Juven (Ross Products) protein supplement|Juven supplement oral x 3 weeks postop
12007131|NCT00539084|Device|MicronJet|The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.
12007132|NCT00539071|Drug|long-acting injectable risperidone|Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks. Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.Oral risperidone will be given up to Week 4 along with the injections for both groups to provide a transition phase.At Week 6, psychopathology will be assessed with a PANSS. If no improvement from baseline is shown, the randomized dose of Consta will be increased to 100 mg q 2 weeks (given as two 50 mg injections ) for those in the high dose Consta group. The dose for those randomized to the conventional dose group will remain the same (50 mg plus placebo).
12007133|NCT00539071|Drug|long acting injectable risperidone|Study dose remains 50 mg for the length of the study.
12007134|NCT00539071|Drug|long acting injectable risperidone|Beginning dose 75 mg. Can be increased to 100 mg at Week 6.
12007135|NCT00539032|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12007136|NCT00539032|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12007137|NCT00539019|Other|calories measured 5x following wound healing|measure REE at various time points postburn
12007138|NCT00539006|Drug|FPNS|fluticasone propionate nasal spray
12007139|NCT00539006|Drug|FFNS|fluticasone furoate nasal spray
12007140|NCT00539006|Drug|placebo FPNS|placebo nasal spray matching fluticasone propionate nasal spray
12007141|NCT00539006|Drug|placebo FFNS|placebo nasal spray matching fluticasone furoate nasal spray
12007142|NCT00538993|Behavioral|Stage based counseling|
12007143|NCT00538980|Drug|Dasatinib|Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
12007144|NCT00538967|Drug|doxycycline|2 weeks once daily
12007145|NCT00538954|Drug|Post operative laxation (Magnesium Oxide)|20 ml of Magnesium Oxide twice daily from the day after surgery until discharge
12007146|NCT00538954|Dietary Supplement|Preoperative metabolic conditioning postoperative nutritional supplementation|Nutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30
12007147|NCT00538954|Other|Standard ERAS group|
12007148|NCT00538941|Dietary Supplement|Nestlé Noir intense 40 grx2|daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.
12007149|NCT00538941|Dietary Supplement|Nestlé Placebo Chocolate 40 grx2|Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.
12007150|NCT00538928|Other|lung protective ventilation|tidal volume 6 ml/kg ideal body weight
12007151|NCT00538915|Biological|Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]|Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] is a clear or slightly opalescent, colorless to pale yellow sterile solution of 10% protein concentration of immunoglobulin G (100mg/mL). It is packaged as 5g in 50mL solution and 10g in 100mL solution. Dosing will be 300-800 mg/kg based on subject's prior dosing history. Infusions will be every 3 or 4 weeks.
12007152|NCT00538902|Biological|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
12007153|NCT00538902|Biological|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
12007154|NCT00538902|Biological|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously every other week for 104 weeks
12007155|NCT00538889|Drug|Lecozotan SR|
12007156|NCT00538889|Drug|Citalopram|
12007157|NCT00538876|Drug|decitabine|"Decitabine will be administered by intravenous injection at a dose of 20 mg/m2/day as a daily 1hr infusion (Arm A) or by continuous infusion (Arm B) for 3, 5 or 7 days. On the day following the final dose of decitabine, standard 7+3 induction chemotherapy will begin."
12007158|NCT00538863|Drug|Fentanyl sublingual spray|Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg
12007159|NCT00538850|Drug|Fentanyl sublingual spray|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. In the double-blind period of the study, participants received fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, or 1600 µg determined in the open-label titration period of the study.
12007160|NCT00538850|Drug|Placebo|Matching placebo to fentanyl sublingual spray.
12007251|NCT00538213|Biological|GSK Bio's Influenza Vaccine GSK576389A|Single dose, Intramuscular injection
12007316|NCT00537810|Behavioral|Self-help CBT + Sibutramine|Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
12007426|NCT00537121|Drug|vorinostat|Taken Orally
12007161|NCT00538824|Drug|dexamethasone|"Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
~After completing 4 cycles:
~Patients who demonstrate disease progression at any time will be taken off study.
~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
~Maintenance therapy will consist of:
~• Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)"
12007162|NCT00538824|Drug|thalidomide|"Cycles 1-4
~• Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle.
~After completing 4 cycles:
~Patients who demonstrate disease progression at any time will be taken off study.
~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy."
12007163|NCT00538824|Drug|lenalidomide|"Cycles 1-4 • Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.
~After completing 4 cycles:
~Patients who demonstrate disease progression at any time will be taken off study.
~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
~Maintenance therapy will consist of:
~• Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of < 40cc/min*"
12007164|NCT00538811|Drug|interferon alpha-2b, ribavirin, interferon-gamma,|
12007165|NCT00538811|Drug|interferon alpha-2b, ribavirin, amantadine|
12007166|NCT00538798|Drug|[18F]SP203|
12007167|NCT00538785|Biological|Motavizumab|15 mg/kg IM administered at monthly intervals
12007168|NCT00538785|Biological|Palivizumab|15 mg/kg IM administered at monthly intervals
12007169|NCT00538772|Other|Not applicable - blood tests/tissue specimen tests will be undertaken|Not applicable - blood tests/tissue specimen tests will be undertaken
12007170|NCT00538759|Device|External beam radiation therapy|Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty
12007171|NCT00538759|Other|Sham Control|
12007172|NCT00538746|Device|BIPAP|
12007173|NCT00538746|Device|PSV|
12007174|NCT00538746|Device|PSV + CPAP|
12007175|NCT00538733|Drug|thalomid|"Cycles 1-4
~• Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)"
12007176|NCT00538733|Drug|lenalidomide|"During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)
~• Lenalidomide (25 mg daily days 1-21 of every 28 day cycle)
~During BiRD phase • 25mg daily days 1-21 of every 28 day cycle)
~During Maintenance Phase
~• 25 mg daily for days 1-21 out of a 28 day cycle"
12007177|NCT00538733|Drug|clarithromycin|"During T-BiRD Phase • Clarithromycin (500mg twice daily for each 28 day cycle)
~During BiRD Phase:
~• Clarithromycin (500mg twice daily for each 28 day cycle)"
12007178|NCT00538733|Drug|dexamethasone|"During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)
~• Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
~During BiRD Phase:
~• Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
~During Maintenance Phase
~• Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle)"
12007179|NCT00538720|Drug|Vitamin D|Starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week).
12007180|NCT00538720|Device|Four-dimensional computed tomography (4DCT)|Four-dimensional computed tomography (4DCT) scan of the neck.
12007181|NCT00538707|Behavioral|2-minute Bondet test|2-minute Bondet test
12007182|NCT00538694|Drug|daptomycin|
12007183|NCT00538681|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression
12007184|NCT00538681|Drug|pemetrexed|500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle
12007185|NCT00538681|Drug|cisplatin|75 mg/m², IV, every 21 days, for each 21-day cycle
12007186|NCT00538681|Drug|placebo|po, QD
12007187|NCT00538668|Drug|117Lu-J591|There will be 9 groups of patients. The first group will receive 20 units of test drug and the 9th group will receive 55 units of the test drug. The exact dose of the test drug will depend upon how many patients have been included in this protocol at the time of patient enrollment. Patients will receive 20-55 units (or millicuries) of radioactivity depending upon patient specific height and weight. The assignment of each patient for a specific dose level is purely based on the sequence of recruitment basis and does not depend on the clinical status of the patient.
12007188|NCT00538655|Drug|modafinil|400mg vs. 200mg (PO) daily
12007189|NCT00538642|Drug|ziprasidone|Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic
12007190|NCT00538629|Other|no intervention|No intervention
12007191|NCT00538616|Drug|Dexmedetomidine|in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
12007192|NCT00538616|Drug|Propofol|in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
12007193|NCT00538603|Drug|pegylated liposomal Doxorubicin (CAELYX) & Carboplatin|Chemotherapy
12007194|NCT00538603|Drug|Paclitaxel & Carboplatin|Chemotherapy
12007195|NCT00538590|Device|Collagen Matrix in Glaucoma Filtering Surgery|Collagen Matrix implantation in Glaucoma Filtering Surgery
12007309|NCT00537823|Drug|Cetuximab|
12007310|NCT00537823|Drug|Bevacizumab|
12007311|NCT00537823|Drug|Leucovorin|
12007196|NCT00538590|Drug|Mitomycin-C(MMC) and glaucoma filtering surgery|If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
12007197|NCT00538564|Drug|tadalafil|10mg oral tablets taken 3 times a week for 2 months
12007198|NCT00538564|Drug|placebo|Placebo tablets taken orally 3 times a week for 2 months
12007199|NCT00538551|Other|Database|Database
12007200|NCT00538538|Drug|vitrectomy with subretinal lucentis|A gas bubble will be placed in the eye after the gel has been removed.
12007201|NCT00538538|Drug|vitrectomy with subretinal lucentis|These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.
12007202|NCT00538525|Drug|Doxorubicin, Docetaxel, Cisplatin|Doxorubicin, Docetaxel, Cisplatin
12007203|NCT00538512|Biological|Fluzone|single dose licensed trivalent inactivated influenza vaccine (2007-08)
12007204|NCT00538512|Biological|Flumist|single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
12007205|NCT00538512|Other|Physiologic saline|single dose placebo administered as an intranasal spray or intramuscular injection
12007206|NCT00538499|Drug|Fentanyl citrate|
12007207|NCT00538499|Drug|Bupivacaine hydrocloride|
12007208|NCT00538499|Procedure|videothoracoscopy|
12007209|NCT00538486|Drug|Telmisartan plus Metformin|Telmisartan 80mg 1/d, Metformin 250mg 2/d
12007210|NCT00538486|Drug|Telmisartan|Telmisartan 80mg 1/d
12007211|NCT00538486|Drug|Candesartan|Candesartan 8mg daily
12007212|NCT00538486|Drug|Candesartan plus Metformin|Candesartan 8mg 1/d Metformin 250mg 2/d
12007213|NCT00538486|Drug|Amlodipine|Amlodipine 5mg 1/d
12007214|NCT00538486|Drug|Amlodipine plus Metformin|Amlodipine 5mg 1/d, Metformin 250mg 2/d
12007215|NCT00538473|Biological|GSK Biologicals' influenza vaccine GSK576389A|Single dose, intramuscular injection
12007216|NCT00538473|Biological|Fluarix™|Single dose, intramuscular injection
12007217|NCT00538447|Other|Database|data base for CML
12007218|NCT00538434|Biological|Reslizumab|
12007219|NCT00538434|Other|Saline|
12007220|NCT00538421|Drug|Propofol|Infusion intravenously (IV) 0-10 mg/kg/h
12007221|NCT00538421|Drug|Sevoflurane|0,7-1,5 MAC
12007222|NCT00538408|Procedure|Whole body magnetic resonance angiography (dotarem)|
12007223|NCT00538408|Device|Whole body magnetic resonance angiography (vasovist)|
12007224|NCT00538395|Drug|Adriamycin, Taxol and Cytoxan|Chemotherapy
12007225|NCT00538382|Drug|Artesunate|A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
12007226|NCT00538369|Other|Ramsay Scale|While receiving sedation, subjects will be monitored with the Ramsay scale
12007227|NCT00538369|Device|Bispectral index monitor|While receiving sedation, subjects will receive BIS monitoring
12007228|NCT00538356|Device|ICD or CRT-D with Home Monitoring feature deactivated|Standard care
12007229|NCT00538356|Device|ICD or CRT-D with Home Monitoring feature activated|Standard care + patient management by Home Monitoring
12007230|NCT00538343|Drug|berubicin hydrochloride (RTA 744)|
12007231|NCT00538330|Drug|Tamoxifen|Tamoxifen
12007232|NCT00538317|Drug|tirofiban|bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
12007233|NCT00538317|Drug|tirofiban|bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
12007234|NCT00538304|Drug|bimatoprost eye drops|1 drop in each eye daily for 1 month
12007235|NCT00538304|Drug|placebo|1 drop in each eye daily for 1 month
12007236|NCT00538291|Biological|cetuximab|
12007237|NCT00538291|Drug|capecitabine|
12007238|NCT00538291|Genetic|gene expression analysis|
12007239|NCT00538291|Genetic|microarray analysis|
12007240|NCT00538291|Genetic|polymorphism analysis|
12007241|NCT00538291|Genetic|reverse transcriptase-polymerase chain reaction|
12007242|NCT00538291|Other|immunohistochemistry staining method|
12007243|NCT00538278|Other|Database|database
12007244|NCT00538265|Drug|tacrolimus|Tacrolimus started at 0.50 mg/kg b.i.d. starting at D0, by nasogastric tube and then 1 to 2 hours before meals. The dose of tacrolimus will be adjusted as soon as possible to obtain trough concentrations of the product between 10 and 20 µg/L between D0 and 6 months and then between 8 and 15 µg/L after 6 months
12007245|NCT00538265|Drug|tacrolimus, ATG|"immunoprophylaxis allowing sparing of steroids in maintenance therapy combining induction therapy with 3 injections of antithymocyte globulins (ATG) (1.5 mg/kg/d at D0, D2 and D4) and tacrolimus at usual dosage.
~In this group of patients, the first injection of ATG will be infused over a period of at least 6 hours and will be started as soon as vascular anastomosis has been completed. It will be preceded by an injection of 3 mg/kg/d methylprednisolone. The second injection of ATG at D2, post transplantation will also be infused over 6 hours and will be preceded by an injection of 1 mg/kg methylprednisolone, and then subsequently steroids will be excluded from the treatment. The third and last injection at D4 post transplantation will be administered over a 6-hour period but will not be preceded by steroids.
~In this study arm, tacrolimus will be administered as in arm (A)"
12007246|NCT00538265|Drug|ATG+mycophénolate mofétil+tacrolimus|"immunoprophylaxis allowing sparing of steroids in maintenance therapy combined with mycophenolate mofetil, at an initial dosage of 2 grams a day, and then adjusted to safety and tolerability in such a way so as to maintain PMN ≥ 750/mm3, and platelet counts ≥ 30000/mm3.
~In this study arm, the patients will receive the same doses of ATG and steroids (and according to the same methods) as in arm B. Tacrolimus started at 0.05 mg/kg b.i.d. starting at D0 by nasogastric tube and then 1 to 2 hours before meals. In this study arm, the tacrolimus dose will be reduced: targeted trough concentrations will be between 7 and 12 µg/L between D0 and 6 months and then between 3 et 7 µg/L after 6 months."
12007247|NCT00538239|Drug|ridaforolimus|Four 10 mg tablets taken by mouth for 5 days per week continuously
12007248|NCT00538239|Drug|Placebo|Four 10 mg tablets taken by mouth for 5 days per week continuously
12007249|NCT00538226|Device|External Electric Muscle Stimulation|
12007312|NCT00537823|Drug|Oxaliplatin|
12007252|NCT00538200|Dietary Supplement|Oral Nutritional Supplements (Fortisip)|These products are classified as non-medicinal, borderline substances, foods for special medical purposes. A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 3 month period.
12007253|NCT00538200|Other|Dietary Advice|Standard dietary advice
12007254|NCT00538187|Drug|obatoclax mesylate|Given IV
12007255|NCT00538187|Drug|bortezomib|Given IV
12007256|NCT00538187|Other|laboratory biomarker analysis|correlative study
12007257|NCT00538187|Other|pharmacological study|correlative study
12007258|NCT00538174|Drug|Dapagliflozin|Tablets, Oral, once daily up, to 14 days
12007259|NCT00538174|Drug|placebo|Tablets, Oral, 0 mg, once daily, up to 14 days
12007260|NCT00538161|Other|Ventilation strategy|
12007261|NCT00538148|Drug|Telithromycin|
12007262|NCT00538135|Behavioral|Cognitive Behavioural Therapy|
12007263|NCT00538135|Other|Treatment as usual|Standard National Health Service treatment as usual for borderline personality disorder
12007264|NCT00538122|Device|24 Holter Monitor Recording|"All subjects will be fitted with a device to obtain 24-hour Holter EKG continuous recordings of bipolar leads C5C5R. They will also receive a standard 12-lead EKG recording prior to the placement of the Holter device. The subjects will be asked to keep a diary during the course of the 24 hours to record information such as wake and sleep times and symptoms such as shortness of breath, heart palpitations, lightheadedness, etc.
~From each recording, 12 sets of 10 consecutive QRS epochs, plus QRS samplings obtained during sleep will be analyzed by a cardiologist blind to the medication status of subjects."
12007265|NCT00538109|Drug|Glivec®/Gleevec®|Chemotherapy
12007266|NCT00538096|Drug|MEDI-538|1 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
12007267|NCT00538096|Drug|MEDI-538|1 of 3 target doses of MEDI-538 (10,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
12007268|NCT00538096|Drug|MEDI-538|1 of 3 target doses of MEDI-538 (15,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
12007269|NCT00538083|Other|Chocolate|74 grams of single dose solid dark chocolate versus placebo
12007270|NCT00538083|Other|Chocolate|22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
12007271|NCT00538083|Other|Chocolate|22 grams of sugared cocoa, sugar-free cocoa, & placebo given for six weeks
12007272|NCT00538070|Dietary Supplement|Sarcosine|You will receive two grams of sarcosine or placebo per day. Each capsule will contain 500 mg of sarcosine or placebo. You will take two capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study.
12007273|NCT00538057|Drug|GW685698X & GW642444M|study drug
12007274|NCT00538044|Drug|simvastatin|medication with simvastation on the dosage of 40mg per day before the operation and all the time after the operation
12007275|NCT00538031|Drug|cyclophosphamide|Given orally
12007276|NCT00538031|Drug|celecoxib|Given orally
12007277|NCT00538018|Drug|Telithromycin|
12007278|NCT00538005|Biological|bevacizumab|
12007279|NCT00538005|Drug|oxaliplatin|
12007280|NCT00538005|Drug|sorafenib tosylate|
12007281|NCT00537992|Procedure|combined surgery|UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure
12007282|NCT00537979|Drug|Paricalcitol injection|Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
12007283|NCT00537979|Drug|Paricalcitol capsules|Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
12007284|NCT00537966|Drug|Dolutegravir|In this arm patients with primary HIV-1 infection are treated with standard antiretroviral combination therapy (only drugs that have been approved by Swiss Medic)
12007285|NCT00537966|Drug|Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate|standard dosage
12007286|NCT00537966|Drug|Raltegravir|standard dosage
12007287|NCT00537966|Drug|Darunavir|standard dosage
12007288|NCT00537966|Drug|Ritonavir|used only as booster for the protease inhibitors that are prescribed in this study according to standard boosting
12007289|NCT00537966|Drug|Rilpivirine|standard dosage
12007290|NCT00537966|Drug|Lamivudine|standard dosage
12007291|NCT00537966|Drug|tenofovir|standard dosage
12007292|NCT00537966|Drug|Emtricitabine|standard dosage
12007293|NCT00537966|Drug|Abacavir|standard dosage
12007294|NCT00537953|Drug|Miltefosine , meglumine antimoniate|
12007295|NCT00537940|Drug|Pregabalin|150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
12007296|NCT00537940|Drug|Gabapentin|300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
12007297|NCT00537927|Procedure|laparoscopic correction of hernia with mesh|Correction of hernia with mesh and fixation of mesh using one of the arms.
12007298|NCT00537914|Drug|Somatropin|Infant, Small for Gestational Age, Omnitrope®/Somatropin, rhGH,
12007299|NCT00537901|Radiation|First-Line Bevacizumab and Chemotherapy|Chemotherapy
12007300|NCT00537901|Drug|Bevacizumab|Chemotherapy
12007301|NCT00537888|Drug|fluconazole|Intravenous or oral 400 md/d
12007302|NCT00537875|Dietary Supplement|Ginger|Capsule, 1000 mg, BID, 3 days
12007303|NCT00537875|Dietary Supplement|Placebo|Capsule, 1000 mg, BID, 3 days
12007304|NCT00537862|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12007305|NCT00537849|Device|Sonablate 500(SB-500)|
12007306|NCT00537836|Drug|BAY 86-5310 (ZK 283197)|3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks
12007307|NCT00537836|Drug|Placebo|Placebo, once daily p.o. over 8 weeks
12007308|NCT00537836|Drug|17ß-estradiol|1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks
12007317|NCT00537810|Behavioral|Self-help CBT + Placebo|Cognitive behavioral treatment manual for binge eating Placebo daily
12007318|NCT00537797|Other|FDG-PET Scan|Positron emission tomography with 18F-fluorodeoxyglucose
12007319|NCT00537784|Biological|Autologous platelets|Local injection 10mL, about 2.5 x 10E10 platelets.
12007320|NCT00537784|Biological|no injection|
12007321|NCT00537771|Drug|Anastrozole|1 mg once daily oral dose
12007322|NCT00537771|Drug|Tamoxifen|20 mg once daily oral dose
12007323|NCT00537758|Behavioral|Cognitive Behavior Therapy|
12007324|NCT00537758|Behavioral|CBT and BWL|
12007325|NCT00537758|Behavioral|Behavioral Weight Loss Treatment|
12007326|NCT00537745|Drug|Vivitrol (Medication Therapy)|Vivitrol 380 mg/monthly
12007327|NCT00537745|Other|Medication Management Therapy|Medication Management Therapy once a month.
12007328|NCT00537732|Drug|omeprazole|20 mg daily
12007329|NCT00537732|Drug|omeprazole|20 vs. 60 mg daily, genotype dependent
12007330|NCT00537719|Drug|GSK716155|albiglutide subcutaneous injection
12007331|NCT00537719|Drug|Placebo|placebo injection
12007332|NCT00537693|Procedure|Continuous Renal Replacement Therapy|Patients will be randomized to either arm for the first 24 hours of the study and then crossover to the second arm for the second 24 hours of the study.
12007333|NCT00537680|Drug|Idebenone|Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients > 45 kg/99 lbs: idebenone 900 mg/day
12007334|NCT00537680|Drug|Idebenone|Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients > 45 kg/99 lbs: idebenone 2250 mg/day
12007335|NCT00537680|Drug|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
12007336|NCT00537667|Drug|anakinra|anakinra
12007337|NCT00537667|Drug|anakinra and PEG sTNF-R1|anakinra and PEG sTNF-R1
12007338|NCT00537654|Drug|Treatment sequence A|Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state
12007339|NCT00537654|Drug|Treatment sequence B|Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state
12007340|NCT00537654|Drug|Treatment sequence C|Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state
12007341|NCT00537654|Drug|Treatment sequence D|Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state
12007342|NCT00537615|Drug|PD 0332334|
12007343|NCT00537602|Drug|miglustat|
12007344|NCT00537602|Drug|placebo|
12007345|NCT00537589|Procedure|Ultrasound guided arthrocentesis|Guidance of joint aspiration by ultrasound guidance
12007346|NCT00537576|Biological|Low dose LACTIN-V applicator|Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days
12007347|NCT00537576|Biological|Medium dose LACTIN-V applicator|Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
12007348|NCT00537576|Biological|High dose LACTIN-V applicator|High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
12007349|NCT00537576|Other|Low dose Placebo applicator|Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
12007350|NCT00537576|Other|Medium dose Placebo|Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
12007351|NCT00537576|Other|High dose Placebo applicator|High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
12007352|NCT00537563|Drug|Telithromycin|
12007353|NCT00537550|Drug|Vincristine|Steroids pre-treatment
12007354|NCT00537550|Drug|Vincristin, Daunorubicine, Asparaginase, Methotrexate|Induction therapy
12007355|NCT00537537|Drug|Telbivudine|
12007356|NCT00537524|Biological|H5N1 Influenza Vaccine|Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
12007357|NCT00537524|Biological|H5N1 Influenza Vaccine|Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
12007358|NCT00537511|Drug|Pomalidomide|
12007359|NCT00537511|Drug|Cisplatin|
12007360|NCT00537511|Drug|Etoposide|
12007361|NCT00537498|Drug|Urokinase|"Daily intravenous application of urokinase over 30 minutes
~Dosage:
~If plasma fibrinogen is > 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is < 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is < 1,6g/l treatment must be stopped and continued after rising up to >2g/l"
12007362|NCT00537485|Drug|SPM 962|transdermal application, 1 time per day
12007363|NCT00537485|Drug|placebo|transdermal application, 1 time per day
12007364|NCT00537472|Drug|Low dose bupivicaine in spinal anesthetic|Bupivacaine 9 mg intrathecal single shot injection at start of surgery
12007365|NCT00537472|Drug|Standard dose bupivacaine in spinal anesthetic|Bupivacaine 13 mg intrathecal single shot injection at start of surgery
12007366|NCT00537459|Drug|16448|
12007367|NCT00537446|Device|noninvasive positive pressure ventilation|Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
12007368|NCT00537446|Device|noninvasive positive pressure ventilation|Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
12007419|NCT00537160|Behavioral|Behavior modification, Nutrition Education, Exercise|
12007420|NCT00537147|Biological|WN/DEN4delta30 vaccine|Live attenuated WN/DEN4delta30 vaccine (one of two doses)
12007421|NCT00537147|Biological|Placebo|Placebo for WN/DEN4delta30 vaccine
12007422|NCT00537134|Device|Embolization, coiling|Endovascular embolization with platinum coils
12007423|NCT00537121|Drug|fluorouracil|Given IV
12007424|NCT00537121|Drug|irinotecan hydrochloride|Given IV
12007369|NCT00537433|Other|Pictogram|"The plain language, pictogram-based medication instruction sheets (available in English and Spanish) utilize pictograms to convey information about the medication name, indication, dose, dose frequency, and length of treatment, along with information about preparation and storage. The sheets also include a medication log for parents to keep track of when they administer the medication.
~Research staff reference the sheets as they demonstrate dosing with a standardized dosing instrument; teachback is performed to reinforce concepts. For medications in which a standardized dosing instrument was not included at dispensing, a standardized oral dosing syringe is provided for the caregiver to use at home. After counseling, the caregiver is given the instruction sheet to take home."
12007370|NCT00537420|Drug|Nasal Placebo|Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
12007371|NCT00537420|Drug|Placebo Capsule|Placebo capsules will be taken once daily with or without food.
12007372|NCT00537420|Drug|PYY3-36|Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
12007373|NCT00537420|Drug|PYY3-36|Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
12007374|NCT00537420|Drug|PYY3-36|Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
12007375|NCT00537420|Drug|Sibutramine|Sibutramine will be taken once daily with or without food
12007376|NCT00537407|Drug|Debio 025|Debio 025 supplied as a 100 mg/mL oral solution
12007377|NCT00537407|Drug|Peg-IFNα2a|Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
12007378|NCT00537407|Drug|Ribavirin|Ribavirin supplied as 200 mg tablets
12007379|NCT00537394|Drug|Enfuvirtide|90mg subcutaneously twice daily
12007380|NCT00537394|Drug|Raltegravir|400 mg twice daily
12007381|NCT00537394|Drug|Darunavir|Two 300-mg tablets twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study)
12007382|NCT00537394|Drug|Tipranavir|Two 250-mg capsules twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study)
12007383|NCT00537394|Drug|Etravirine|Two 100-mg tablets twice daily
12007384|NCT00537394|Drug|Maraviroc|Dosage dependent on regimen in which maraviroc is included
12007385|NCT00537381|Drug|Docetaxel|Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks.
12007386|NCT00537381|Drug|Prednisone|Prednisone 5 mg orally twice daily.
12007387|NCT00537381|Biological|Intetumumab|Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
12007388|NCT00537381|Drug|Placebo|Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
12007389|NCT00537368|Drug|CNTO 888|
12007390|NCT00537355|Biological|Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate|6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg)
12007391|NCT00537355|Drug|Histamine|6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)
12007392|NCT00537342|Biological|Immunotherapy with modified extract of O. europaea pollen|Sublingual (2 drops daily during 2 months)
12007393|NCT00537329|Drug|Anidulafungin|Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days.
12007394|NCT00537316|Biological|Infliximab (IFX)|IFX intravenous (IV) infusion dosed at 5mg/kg of body weight
12007395|NCT00537316|Drug|Azathioprine (AZA)|AZA 50 mg tablet dosed at 2.5 mg/kg of body weight orally every day
12007396|NCT00537316|Drug|Placebo to Azathioprine|Placebo to AZA tablet orally every day
12007397|NCT00537316|Drug|Placebo infusion|Placebo to IFX intravenous (IV) infusion
12007398|NCT00537303|Drug|insulin detemir|Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
12007399|NCT00537303|Drug|insulin aspart|Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
12007400|NCT00537303|Drug|insulin aspart|Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)
12007401|NCT00537290|Drug|Rituximab|Rituximab 1000mg IV on Days 0 and 15
12007402|NCT00537277|Drug|biphasic insulin aspart|Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)
12007403|NCT00537264|Other|Health-related quality of life assessment|Study participants will be asked to complete the following health-related quality of life questionnaires: EQ-5D, Health Utilities Index 3, SF-8 and SF-6D. The Singapore (Chinese) versions of these questionnaires have been previously tested and validated in a pilot cohort of the same study population.
12007404|NCT00537264|Other|Health-related quality of life assessment|Study participants will be asked to complete the following health-related quality of life questionnaires: EQ-5D, Health Utilities Index 3, SF-8 and SF-6D. The Singapore (Chinese) versions of these questionnaires have been previously tested and validated in a pilot cohort of the same study population.
12007405|NCT00537251|Drug|Insulin glargine|
12007406|NCT00537238|Drug|pregabalin|300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
12007407|NCT00537238|Drug|levetiracetam|1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
12007408|NCT00537225|Behavioral|exercise|tailored multifactor CVD risk reduction
12007409|NCT00537212|Other|The South Beach Diet|"Subjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss. Subjects also receive a copy of The South Beach Diet."
12007410|NCT00537212|Other|The Ornish Diet|"Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of The Ornish Diet book."
12007411|NCT00537212|Other|Control Group|This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet.
12007412|NCT00537199|Other|Visual Examination|Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.
12007413|NCT00537199|Drug|OraTest|Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.
12007414|NCT00537186|Drug|Iron oligosaccharide|
12007415|NCT00537173|Procedure|Core Biopsy|biopsy
12007416|NCT00537173|Procedure|Blood Collection|Blood/serum sample
12007417|NCT00537173|Drug|Paclitaxel|Paclitaxel 90 mg/m2 IV, day 1, 8 and 15
12007418|NCT00537173|Drug|Avastin|Avastin 10 mg/kg IV, day 1 and 15
12007427|NCT00537121|Other|pharmacological study|Correlative Study
12007428|NCT00537108|Behavioral|Home visiting and care management|Third trimester teens are assigned a Care Manager (CM) who establishes a continuity relationship and provides monthly visits until the index child is 2 years old. Core services for intervention group include: 1)Baseline and ongoing assessment of health, mental health, housing, daycare, and school needs; 2)Administration of a culturally sensitive, developmentally relevant parenting curriculum; 3)Computer Assisted Motivational Interviewing to promote healthy relationships, improve contraceptive practices, focus on goals, and promote school continuation; 4)Efforts to engage the young father; 5)Linkage and coordination with primary care for teen, child, young father; 6)Support & skills-building for school continuation, higher education, and job readiness.
12007429|NCT00537095|Drug|Vandetanib|300 mg oral once daily oral dose
12007430|NCT00537095|Other|Placebo|
12007431|NCT00537082|Drug|FTY720|Administered orally once daily for 6 months
12007432|NCT00537082|Drug|Placebo|Administered orally once daily for 6 months
12007433|NCT00537056|Procedure|FDG PET CT|nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
12007434|NCT00537056|Procedure|DCE MRI|DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
12007435|NCT00537056|Drug|F-18 Fluoro-deoxi-glucose|15 mCi iv
12007436|NCT00537056|Drug|Gadolinium-DTPA|0.1 mmol/kg iv
12007437|NCT00537056|Drug|Sunitinib|50 mg/day po
12007438|NCT00537043|Drug|SK&F-105517 (COREG CR FDC)|
12007439|NCT00537030|Drug|Asparaginase|Given IM
12007440|NCT00537030|Other|Laboratory Biomarker Analysis|Correlative studies
12007441|NCT00537030|Other|Pharmacological Study|Correlative studies
12007442|NCT00537017|Drug|Preladenant|5 mg BID capsules
12007443|NCT00537017|Drug|L-dopa|Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).
12007444|NCT00537017|Drug|Other Parkinson's Disease treatments|Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.
12007445|NCT00536991|Dietary Supplement|Calcitriol|Given PO
12007446|NCT00536991|Drug|Ketoconazole|Given PO
12007447|NCT00536991|Other|Laboratory Biomarker Analysis|Correlative studies
12007448|NCT00536991|Other|Pharmacological Study|Correlative studies
12007449|NCT00536991|Drug|Therapeutic Hydrocortisone|Given PO
12007450|NCT00536978|Drug|ARA-C|100 mg/m^2 IV Daily Over 1 Hour for 4 Days
12007451|NCT00536978|Drug|BCNU|300 mg/m^2 IV Over 1 Hour for 1 Day
12007452|NCT00536978|Drug|Campath-1H|15 mg IV Daily Over 30 Minutes for 3 Days
12007453|NCT00536978|Drug|Cyclophosphamide|1000 mg/m^2 IV Daily Over 1 Hour for 3 Days
12007454|NCT00536978|Drug|Etoposide|100 mg/m^2 IV Daily Over 3 Hours for 4 Days
12007455|NCT00536978|Drug|Fludarabine|30 mg/m^2 IV Daily Over 1 Hour for 3 Days
12007456|NCT00536978|Drug|Melphalan|100 mg/m^2 IV Over 30 Minutes for 1 Day.
12007457|NCT00536978|Drug|Rituximab|375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks.
12007458|NCT00536978|Other|Allogeneic Stem Cell Transplantation|Stem Cell Infusion on Day 0.
12007459|NCT00536978|Radiation|Total body radiation (TBI)|TBI on Day 5 following chemotherapy, before stem cell infusion.
12007460|NCT00536978|Drug|Methotrexate|5 mg/m2 IV on Days +1, +3, and +6.
12007461|NCT00536978|Drug|Tacrolimus|0.03 mg/kg/day IV starting on Day -2, to be given through day 60, tapered by 20% every week, then discontinue by day 90.
12007462|NCT00536978|Procedure|Adback NK or T Cell|Adback natural killer (NK) cells or T cells after transplantation to enhance full engraftment of donor cells. Cell adback after transplantation applies only if there is no active GVHD, and no previous episode of grade II-IV GVHD.
12007463|NCT00536952|Drug|Pulmozyme|Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
12007464|NCT00536952|Drug|Placebo|Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
12007465|NCT00536952|Radiation|Radiation Therapy|5 days per week for 4 weeks
12007466|NCT00536939|Drug|Enzastaurin|1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
12007467|NCT00536939|Drug|Bevacizumab|10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
12007468|NCT00536939|Drug|Paclitaxel|90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
12007469|NCT00536939|Drug|Placebo|Oral, daily, until disease progression
12007470|NCT00536926|Device|Home spirometry with data transfer via cell phone|home spirometry recording
12007471|NCT00536926|Device|Home spirometer with BT-cellphone|Data transfer of home spirometry recordings via bluetooth to clinical database.
12007472|NCT00536926|Device|Home spirometer w/o BT|Standard home spirometry
12007473|NCT00536913|Drug|Budesonide/formoterol pMDI 40/2.25ug + spacer|
12007474|NCT00536913|Drug|Budesonide/formoterol pMDI 40/2.25 ug|
12007475|NCT00536900|Behavioral|Advisor-Teller Money Manager|The acronym for the functions of ATM are TTT-- Teller (storing patient funds), Training patients by making and reviewing monthly budgets, and Treatment-Linked Spending in which weekly behavioral contracts link disbursement to completion of abstinence-related activities
12007476|NCT00536900|Behavioral|FIT|FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets
12007477|NCT00536887|Drug|atorvastatin|atorvastatin 10 mg versus 40 mg during the 8 months of follow-up
12007478|NCT00536874|Drug|gemcitabine hydrochloride|1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
12007479|NCT00536874|Drug|oxaliplatin|80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
12007480|NCT00536874|Genetic|protein expression analysis|
12007481|NCT00536874|Genetic|proteomic profiling|
12007482|NCT00536874|Other|diagnostic laboratory biomarker analysis|
12007483|NCT00536874|Procedure|adjuvant therapy|
12007484|NCT00536874|Procedure|neoadjuvant therapy|
12007485|NCT00536874|Procedure|therapeutic conventional surgery|
12007486|NCT00536861|Drug|erlotinib|"Level 1 : erlotinib 100 mg/day from day -7 to the time of completion of 10 fractions of cranial irradiation, followed by 150 mg/day until disease progression or toxicity
~Level 2 : erlotinib 150 mg/day from day -7 before cranial irradiation, followed by 150 mg/day until disease progression or toxicity"
12007487|NCT00536848|Dietary Supplement|Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14|
12007488|NCT00536848|Dietary Supplement|Placebo|
12007489|NCT00536848|Drug|Metronidazole|
12007490|NCT00536835|Drug|GSK461364|GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.
12007491|NCT00536809|Drug|lapatinib|onced daily Days 1-21
12007492|NCT00536809|Drug|oxaliplatin|Day one of each cycle
12007493|NCT00536809|Drug|capecitabine|given BID days 1-14
12007494|NCT00536783|Drug|Quetiapine|
12007495|NCT00536770|Drug|placebo + gemcitabine + erlotinib|
12007496|NCT00536770|Drug|Placebo + gemcitabine|
12007497|NCT00536770|Drug|calcitriol + gemcitabine|
12007498|NCT00536770|Drug|calcitriol + gemcitabine + erlotinib|
12007499|NCT00536744|Device|acoustical pulse energy (extracorporeal shockwave)|Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.
12007500|NCT00536744|Other|Sham|Non-energized (inactive - Sham) application + standard of care
12007501|NCT00536731|Drug|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
12007502|NCT00536731|Drug|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
12007503|NCT00536731|Drug|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
12007504|NCT00536718|Genetic|gene expression analysis|
12007505|NCT00536718|Genetic|molecular diagnostic method|
12007506|NCT00536718|Genetic|polymorphism analysis|
12007507|NCT00536718|Genetic|protein expression analysis|
12007508|NCT00536718|Other|medical chart review|
12007509|NCT00536718|Other|questionnaire administration|
12007510|NCT00536705|Drug|montelukast|montelukast 5-mg chewable tablet with matching placebo once daily in the evening at bedtime.The study consisted of a 2-week, single-blind placebo baseline period and a 12-week double-blind, active treatment period
12007511|NCT00536692|Drug|mecamylamine|topical ocular drops
12007512|NCT00536679|Drug|GSK163090 capsule, fasted|GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water.
12007513|NCT00536679|Drug|GSK163090 Tablet, fasted|GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water.
12007514|NCT00536679|Drug|GSK163090 Tablet, fed|GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast.
12007515|NCT00536666|Drug|Iron oligosaccharide|
12007516|NCT00536653|Drug|Bicalutamide and Calcium/ Vitamin D supplementation|Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
12007517|NCT00536653|Drug|LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation|3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily
12007518|NCT00536653|Drug|LHRH agonists (Goserelin acetate)|3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)
12007519|NCT00536640|Drug|Erlotinib|150 mg per os, given daily until tumor progression
12007520|NCT00536640|Drug|Bevacizumab|15mg/kg i.v. on day 1 (three-week cycle) until tumor progression
12007521|NCT00536640|Drug|Gemcitabine|1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles
12007522|NCT00536640|Drug|Cisplatin|80 mg/m2 i.v. on day 1 (three-week cycle) until tumor progression for a maximum of 6 cycles. (The administration of 40 mg/2 Cisplatin on day 1 and day 8 is also possible)
12007523|NCT00536627|Biological|DNA vaccine pCMVS2.S|Patients will receive injections of 1 ml of vaccine (1 mg/ml) at weeks 0, 8, 16, 40 and 44
12007524|NCT00536614|Genetic|cetuximab|Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.
12007525|NCT00536601|Drug|etoposide|Given IV
12007526|NCT00536601|Drug|cyclophosphamide|Given IV
12007527|NCT00536601|Drug|carmustine|Given IV
12007528|NCT00536601|Drug|melphalan|Given IV
12007529|NCT00536601|Drug|busulfan|Given IV
12007530|NCT00536601|Drug|carboplatin|Given IV
12007531|NCT00536601|Drug|thiotepa|Given IV
12007532|NCT00536601|Radiation|total-body irradiation|Undergo TBI
12007533|NCT00536601|Procedure|autologous hematopoietic stem cell transplantation|Undergo ASCT
12007534|NCT00536601|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|Undergo tandem ASCT
12007535|NCT00536588|Genetic|SCH 721015 with SCH 209702|Each subject receives a single intravesical administration of SCH 721015 with SCH 209702 at dose levels of 1 x 10^9 to 3 x 10^11 particles/mL (based on assessment of tolerability, intermediate dose levels may be used).
12007536|NCT00536575|Drug|Bortezomib|"Dose Level 1: Bortezomib 1.3mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.
~Dose Level 2: Bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.
~Dose Level 3: Bortezomib 1.6mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle."
12007537|NCT00536575|Drug|Sorafenib|"Dose Levels 1 and 2: 200 mg by mouth twice daily
~Dose Level 3: 400 mg by mouth twice daily"
12007581|NCT00536198|Drug|Sertraline|50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
12007776|NCT00534781|Device|plasma microdebrider|Coblation of the Achilles
12007538|NCT00536562|Behavioral|Comprehensive Cardiac Rehabilitation (CR)|6-month Comprehensive Cardiac Rehabilitation program consisting of: 1) initial medical assessment by case manager and physician to determine CR strategies; 2) entry exercise stress test; 3) multi-disciplinary assessment and intervention to achieve risk factor targets in nutrition & psychological services as needed; 4) twice per week supervised exercise training and twice per week home-based exercise following an individualized, progressive prescription; 5) Exit assessment at 6 months.
12007539|NCT00536549|Device|Guardian RT|
12007540|NCT00536549|Behavioral|Education about the self monitoring blood glucose|
12007541|NCT00536536|Behavioral|Obesity management framework|Treatment in primary care will be compared to treatment in a secondary hospital setting. Treatment in both cases will be provided by a multi-disciplinary team of: obesity or practice nurse, dietitian, exercise specialist with some input from medical team.
12007542|NCT00536510|Drug|laropiprant/niacin (MK0524A)|"Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks
~Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks.
~All patients will receive placebo for a 4 week run-in period before randomization"
12007543|NCT00536510|Drug|Comparator: placebo|"Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks
~Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks.
~All patients will receive placebo for a 4 week run-in period before randomization."
12007544|NCT00536497|Drug|GW842166X|
12007545|NCT00536484|Drug|Fesoterodine|4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
12007546|NCT00536484|Drug|Placebo|Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
12007547|NCT00536471|Drug|Duloxetine hydrochloride|
12007548|NCT00536471|Drug|Placebo|
12007549|NCT00536458|Procedure|radiotherapy|mini chep+ radiotherapy
12007550|NCT00536458|Drug|MINI CHEP|chemotherapy minichep 6 courses
12007551|NCT00536445|Device|NAVA|Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity)
12007552|NCT00536419|Drug|Methylphenidate|Methylphenidate SODAS 0.3 mg/kg/day (day 1); 0.7 mg/kg/day (day 2); 1.0 mg/kg/day (days 3 and 4)
12007553|NCT00536419|Other|Placebo|Placebo, daily dose, 4 days, oral administration
12007554|NCT00536406|Behavioral|BE-ACTIV|BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
12007555|NCT00536406|Behavioral|Treatment as usual (TAU)|TAU includes usual treatment in nursing care facility.
12007556|NCT00536393|Drug|Doxorubicin|
12007557|NCT00536393|Drug|Doxorubicin pegylated|
12007558|NCT00536380|Drug|5-mg Desloratadine|5-mg desloratadine tablets, once daily for four weeks.
12007559|NCT00536380|Drug|10-mg Desloratadine|10-mg desloratadine tablets, once daily for four weeks.
12007560|NCT00536380|Drug|20-mg Desloratadine|20-mg desloratadine tablets, once daily for four weeks.
12007561|NCT00536367|Other|No intervention - observational study only|
12007562|NCT00536354|Other|Postural Orientation|
12007563|NCT00536341|Drug|lenalidomide|2.5 mg orally (PO) daily, Days 8-28, Cycle 1; 5.0 mg PO daily, Days 8-28 Cycles 2-6
12007564|NCT00536341|Drug|Rituximab|375 mg/m2 Cycle 1 (split over Day 1 & Day 2); 500 mg/m2 Day 1 of Cycles 2-6
12007565|NCT00536341|Drug|Fludarabine|25 mg/m2 on Days 1, 2, and 3
12007566|NCT00536302|Dietary Supplement|Collagen Hydrolysate|Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
12007567|NCT00536302|Dietary Supplement|Placebo|Matching placebo solution per day by mouth for 48 weeks.
12007568|NCT00536289|Device|Blunt needle|Blunt tipped suture needle
12007569|NCT00536276|Dietary Supplement|Vitamin D2|Daily enteral dose of 100IU/kg
12007570|NCT00536276|Dietary Supplement|Vitamin D3|Daily enteral dose of 100IU/kg
12007571|NCT00536263|Drug|pegylated interferon alpha-2b|1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
12007572|NCT00536263|Drug|pegylated interferon alpha-2b|1.5 mcg/kg S.C. QW for 24 weeks
12007573|NCT00536263|Drug|pegylated interferon alpha-2b|1.5 mcg/kg S.C. QW for 48 weeks
12007574|NCT00536237|Drug|Comparator: niacin / Duration of Treatment: 17 Weeks|
12007575|NCT00536237|Drug|MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks|
12007576|NCT00536237|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks|
12007577|NCT00536224|Behavioral|Full counseling|"The health educator generated a computerized report for the patient that outlined his/her Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal. Based on the Ask-Advise-Assess-Assist-Arrange follow-up (5A's) framework for behavior change, counseling for specific risk-related behaviors (diet, physical activity, and smoking) was provided by a cardiovascular rehabilitation health educator in the emergency department and during telephone follow-up (2 sessions over 6 weeks). Patients also received a general informational handout on self-management of cardiovascular risk factors (AHA Brochure Controlling your risk factors). A full report was also be sent to the patient's primary care physician (if any) at the conclusion of counseling."
12007578|NCT00536224|Behavioral|Minimal counseling|"Patients assigned to the minimal counseling intervention received brief counseling (<5 minutes) on the benefits of changing lifestyle and a handout with general information on self-management of cardiovascular risk factors.
~Patients assigned to minimal intervention also received an AHA brochure (Controlling your risk factors) with general information on management of cardiovascular risk factors. At the end of 6-month follow-up, patients received a computerized report that outlined their Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal."
12007579|NCT00536211|Behavioral|Exercise|Exercise training will consist of walking and/or jogging on a treadmill 5 out of 7 d each week at ~60% of each subject's predetermined VO2max (75% maximal heart rate as monitored by heart rate monitors), 45 min/session, for 12 weeks. The exercise training will follow a three-stage progression: 1. wk 1 = 30 min, 3 d/wk, 60% VO2max; 2. wk 2 = 30 min, 5 d/wk, 60% VO2max; and 3. wk 3-12 = 45 min, 5 d/wk, 60% VO2max.
12007580|NCT00536211|Drug|Metformin|oral tablet, 1000 mg daily for 17 days
12007773|NCT00534807|Drug|Rifampin|
12007582|NCT00536198|Drug|Placebo|50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
12007583|NCT00536185|Dietary Supplement|Fish Oil|capsules, 5.0 g/d fish oil concentrate (3.0 g/d EPA + DHA), 6 weeks
12007584|NCT00536185|Dietary Supplement|Placebo|capsule, 5.0 g/d corn/soybean oil (50/50 mixture), 6 weeks
12007585|NCT00536172|Drug|Escitalopram|Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
12007586|NCT00536172|Drug|Placebo|Placebo distribution matches the active medication.
12007587|NCT00536159|Other|Medicaid Maternal and Infant Support Services|Enhanced services include home visiting, transportation, psychosocial counseling, multidisciplinary planning, case management, nutritional guidance, and pregnancy and parenting education during pregnancy and infancy. The services are delivered primarily by nurses with occasional visits by social workers or nutritionists. In the county of the study (Kent), women who were assessed were provided intervention services.
12007588|NCT00536159|Other|Nurse-CHW team|A nurse and two CHWs functioned as a team, using visit and clinical guidelines that detailed expected care. Each team provided services for approximately 50-60 families. While occasional visits were made by both providers, most visits were made by either provider alone. Nurses guided the CHW care, led a multidisciplinary team assessment (with social workers, nutritionists, and others), provided crisis intervention and case management, assessed and managed health problems (including screening for depression and mental health care), and had periodic office visits with prenatal providers. CHWs provided relationship-based support by attempting weekly prenatal contact that alternated phone and face-to-face visits and used peer role modeling and personal empowerment approaches.
12007589|NCT00536133|Drug|Zinc|5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days
12007590|NCT00536133|Other|placebo|5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc
12007591|NCT00536120|Biological|BG00002 (natalizumab)|
12007592|NCT00536120|Biological|keyhole limpet hemocyanin (KLH)|KLH 1 mg administered subcutaneously (SC) in accordance with the Immucothel investigator's brochure.
12007593|NCT00536120|Biological|tetanus diphtheria toxoid vaccine (Td)|Td administered in accordance with the manufacturer's prescribing information.
12007594|NCT00536107|Drug|Gefitinib|250 mg oral
12007595|NCT00536107|Procedure|CT or MRI|performed at screening and every 6 weeks
12007596|NCT00536107|Drug|Docetaxel|60mg/m2 intravenous infusion
12007597|NCT00536094|Behavioral|Cognitive behavioral therapy (CBT)|CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
12007598|NCT00536094|Behavioral|Treatment as usual (TAU)|TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
12007599|NCT00536081|Drug|pegfilgrastim|6 mg s.c. 24-36 h post-chemotherapy
12007600|NCT00536068|Drug|Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo|"Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days
~Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days
~Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days
~Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days"
12007601|NCT00536042|Drug|Minocycline|addition of 150 mg to 250 mg po bid to standard asthma care regiment
12007602|NCT00536016|Drug|JSM6427|Weekly intravitreal injections for up to 4 weeks, first dose strength is one dose below the MTD. Dose strength concentrations: 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml 04 15 mg/ml.
12007603|NCT00536003|Drug|progesterone|vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
12007604|NCT00536003|Drug|placebo|vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
12007605|NCT00535977|Dietary Supplement|Broccoli|400g ITC-enriched broccoli per week for 12 months
12007606|NCT00535977|Dietary Supplement|Peas|400g frozen garden peas per week for 12 months
12007607|NCT00535951|Drug|LBH589|
12007608|NCT00535938|Other|botulinum toxin type A|There will be no protocol-mandated intervention with regard to physician treatment choice or management of patient condition once the patient is enrolled in the project.
12007609|NCT00535925|Drug|SoC therapy|the patients have to be treated according the standard good medical practice by any center
12007610|NCT00535925|Drug|irbesartan|"Therapy for hypertension:
~- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die"
12007611|NCT00535925|Drug|ramipril|"Therapy for hypertension:
~- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die"
12007612|NCT00535925|Drug|hydrochlorothiazide|"Therapy for hypertension
~- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)"
12007613|NCT00535925|Drug|furosemide|"Therapy for hypertension
~- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)"
12007614|NCT00535925|Drug|amlodipine|"Therapy for hypertension
~- Step 3: amlodipine up to 10 mg/die"
12007615|NCT00535925|Drug|atenolol|"Therapy for hypertension
~- Step 4: atenolol up to 100 mg/die"
12007616|NCT00535925|Drug|doxazosin|"Therapy for hypertension
~- Step 5: doxazosin up to 4 mg/die"
12007617|NCT00535925|Drug|clonidine|"Therapy for hypertension
~- Step 6: clonidine"
12007618|NCT00535925|Drug|insulin|"Therapy for Hyperglycaemia (to achieve HbA1c <7):
~- insulin"
12007619|NCT00535925|Drug|simvastatin|"Therapy for hypercholesterolemia:
~- for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die"
12007620|NCT00535925|Drug|fibrate|"Therapy for hypertriglyceridemia
~- for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate"
12007621|NCT00535925|Drug|erythropoietin|"Treatment of anaemia:
~- erythropoietin"
12007622|NCT00535925|Drug|aspirin|"Antiplatelet therapy (in all patients without contraindications):
~- aspirin up to 160 mg/die"
12007623|NCT00535912|Procedure|Stem cells autograft|Treatment by Intensive Chemotherapy and autograft
12007624|NCT00535886|Dietary Supplement|Man-made Trans FA|EA as 6% of total energy
12007625|NCT00535886|Dietary Supplement|Natural Trans FA|VA as 6% of total energy
12007626|NCT00535886|Dietary Supplement|Oleic Acid|OA as 6% of total energy
12007774|NCT00534794|Drug|Elestat|Elestat BID for 2 days
12007627|NCT00535873|Drug|Lenalidomide|Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
12007628|NCT00535860|Drug|Teriparatide|Daily for 96 days
12007629|NCT00535847|Drug|Telaprevir|Tablet
12007630|NCT00535847|Drug|Ribavirin|Tablet
12007631|NCT00535847|Drug|Pegylated interferon alfa 2a|Solution for Injection
12007632|NCT00535834|Procedure|diagnostic procedure|
12007633|NCT00535834|Procedure|molecular diagnostic method|
12007634|NCT00535834|Procedure|protein expression analysis|
12007635|NCT00535821|Device|Esophageal Doppler monitoring - CardioQ, Deltex Inc|6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
12007636|NCT00535821|Device|Central line with CVP and continuous ScvO2 monitoring|6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
12007637|NCT00535808|Drug|nitroprusside|Administration of nitroprusside
12007638|NCT00535808|Drug|nitroglycerine|Administration of nitroglycerine
12007639|NCT00535808|Drug|sevoflurane|Administration of Sevoflurane
12007640|NCT00535795|Radiation|Radiation Therapy|Radiation Therapy
12007641|NCT00535782|Drug|Tocilizumab|Administered by intravenous infusion, 8 mg/kg every 4 weeks.
12007642|NCT00535782|Drug|Placebo|Placebo to tocilizumab administered by intravenous infusion every 4 weeks.
12007643|NCT00535782|Drug|Methotrexate|Administered orally or parenterally, 7.5-25 mg weekly.
12007644|NCT00535769|Device|Electronic + no text message|Electronic monitor is attached but no text-messages are sent through cellular phones
12007645|NCT00535769|Device|Electronic monitor + text messages|Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use
12007646|NCT00535756|Drug|Creon|3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
12007647|NCT00535756|Drug|Placebo|Placebo
12007648|NCT00535743|Drug|Sugammadex|Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
12007649|NCT00535743|Drug|Placebo|0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
12007650|NCT00535743|Drug|Esmeron®|Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
12007651|NCT00535730|Biological|Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™|0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
12007652|NCT00535730|Biological|Comparator: placebo (concomitant-vaccine matched)|Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
12007653|NCT00535730|Biological|Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23|Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.
12007654|NCT00535717|Procedure|uttarbasti (per urethral administration of medicated oil )|
12007655|NCT00535704|Behavioral|Strong African American Families-Teen Program|5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours.
12007656|NCT00535704|Behavioral|FUEL|5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours
12007657|NCT00535691|Drug|Tacrolimus Ointment 0.03%|Twice daily, 14 days treatment.
12007658|NCT00535691|Drug|Tacrolimus Ointment 0.03%|Once daily, 14 days treatment.
12007659|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 14 days apart: 5 microgram per dose
12007660|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 28 days apart: 5 microgram per dose
12007661|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 28 days apart: 10 microgram per dose
12007662|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 28 days apart: 15 microgram per dose
12007663|NCT00535652|Drug|Ertapenem|powder for infusion, 1 gram I.V., single dose over 30 min.
12007664|NCT00535639|Drug|Betula Verrucosa allergen extract|
12007665|NCT00535626|Device|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell
12007666|NCT00535613|Drug|Propofol|IV, single bolus at completion of anesthetic, 0.1 ml/kg
12007667|NCT00535587|Behavioral|Exercise|
12007668|NCT00535587|Drug|pyridostigmine|
12007669|NCT00535587|Drug|Placibo|
12007670|NCT00535587|Behavioral|Attention Control|
12007671|NCT00535574|Drug|Bexarotene (Targretin LGD1069)|75 mg per day for 6 weeks
12007672|NCT00535574|Drug|bexarotene|75 mg/day 6 weeks
12007673|NCT00535561|Drug|Ferrous sulfate tablets 325 mg, po, TID|
12007674|NCT00535561|Drug|Ferrous sulfate plus levothyroxine|Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID
12007675|NCT00535548|Biological|Stem cell therapy|Injection of a hematopoietic stem cell suspension (50'000 CD 34+ cells per microliter) into the wound (1 microliter per cm2 of wound surface)
12007676|NCT00535535|Dietary Supplement|Fructose|Fructose, 0.5 g/kg
12007677|NCT00535535|Dietary Supplement|Fructose and Glucose|Fructose:Glucose 1:1, 1 g/kg
12007678|NCT00535535|Dietary Supplement|Fructose and Glucose|Fructose:Glucose 1:1, 2g/kg
12007679|NCT00535522|Drug|TAK-285 Dose Escalation Cohorts|TAK-285 50 mg tablet, orally, once or twice daily for three weeks, followed by seven days off. Dose escalation to maximum tolerated dose, with possibility of continuous dosing per cycle (daily dosing for four weeks without a break between cycles).
12007680|NCT00535522|Drug|TAK-285 Recommended Phase 2 Dosing Cohort|Expanded cohort with dose and regimen dependent upon the safety profile of the maximally tolerated dose and schedule determined in the dose escalation phase of the study.
12007681|NCT00535509|Radiation|Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT
12007682|NCT00535509|Other|Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT
12007683|NCT00535509|Drug|Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT
12007684|NCT00535496|Drug|sugammadex|Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.
12007685|NCT00535470|Drug|0.04% Mechlorethamine gel|Mechlorethamine 0.04% PG applied to affected skin areas (lesions) once daily for up to seven (7) months. The frequency of application may be adjusted for toxicity. After seven (7) months, they will be terminated from the study.
12007686|NCT00535457|Other|Preoperative Magic Tricks|"Watching magic; Study patients will watch the anesthesiologist performing tricks (magic) before anesthesia induction."
12007687|NCT00535444|Other|Parish nurse visit|One visit with the parish nurse in 2 weeks
12007688|NCT00535431|Drug|AER 001|60 mg (in nebuliser), twice daily for 28 days
12007689|NCT00535431|Drug|placebo|Sterile saline nebulised, twice daily for 28 days
12007690|NCT00535418|Drug|Letrozole|
12007691|NCT00535405|Drug|Atorvastatin 10 mg|Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
12007692|NCT00535405|Drug|Ezetimibe 10 mg/simvastatin 20 mg|Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
12007693|NCT00535405|Drug|Atorvastatin 20 mg|Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
12007694|NCT00535405|Drug|Ezetimibe 10 mg/simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
12007695|NCT00535405|Drug|Atorvastatin 40 mg|Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
12007696|NCT00535392|Drug|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
12007697|NCT00535379|Drug|Sunitinib|Patients will receive SUTENT 37.5mg (3 x 12.5mg capsules) PO daily in the morning after breakfast. After 2 weeks without treatment-related adverse events grade ≥ 2 (ECOG common toxicity criteria: refer to Protocol Attachment A.4) a SUTENT dose escalation to 50mg (4 x 12.5mg capsules) PO daily has to be performed. Treatment will continue until patients develop progression of disease or until unacceptable adverse events occur.
12007698|NCT00535366|Drug|Tiotropium|Oral inhalation by HandiHaler® device
12007699|NCT00535366|Drug|Salmeterol|Oral inhalation from Diskus®
12007700|NCT00535366|Drug|Fluticasone|Oral inhalation from metered dose inhaler (MDI)
12007701|NCT00535366|Drug|Ciclesonide low|Oral inhalation from MDI
12007702|NCT00535366|Drug|Ciclesonide high|Oral inhalation from MDI
12007703|NCT00535366|Drug|Placebo|Oral inhalation from MDI
12007704|NCT00535353|Drug|irinotecan hydrochloride|In Part A, a continuous oral AZD2281 dose will be given in combination with irinotecan given as a 90 minute infusion on day 1 every 21 days. In Part B, AZD2281 will be given on days 1-5 and irinotecan as a 90 minute infusion on day 3 each cycle. Cycles are repeated every 14 days.
12007705|NCT00535353|Drug|olaparib|In Part A, a continuous oral AZD2281 dose will be given in combination with irinotecan given as a 90 minute infusion on day 1 every 21 days. In Part B, AZD2281 will be given on days 1-5 and irinotecan as a 90 minute infusion on day 3 each cycle. Cycles are repeated every 14 days.
12007706|NCT00535340|Drug|SR58611A|
12007707|NCT00535314|Drug|RTA 402 Dose1|
12007708|NCT00535314|Drug|RTA 402 Dose2|
12007709|NCT00535301|Device|grafted anterior prolapse repair|anterior vaginal prolapse repair with graft
12007710|NCT00535301|Procedure|sutured anterior vaginal prolapse repair|anterior vaginal prolapse repair with suture
12007711|NCT00535288|Drug|Esmirtazapine|Four different doses (2.25, 4.5, 9.0, and 18 mg) encapsulated esmirtazapine tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.
12007712|NCT00535288|Drug|Placebo|Encapsulated placebo tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.
12007713|NCT00535275|Drug|Chemotherapy with platine|Docetaxel 75 mg/m² D1 + Cisplatine 75 mg/m² or Carboplatin AUC5 D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
12007714|NCT00535275|Drug|Chemotherapy without Cisplatine|Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
12007715|NCT00535262|Drug|EmSam|Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
12007716|NCT00535236|Biological|V212|0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
12007717|NCT00535236|Biological|Placebo|0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
12007718|NCT00535223|Behavioral|Group Based Exposure Therapy|GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
12007719|NCT00535223|Behavioral|Present Centered Group Therapy|"Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
12007720|NCT00535210|Behavioral|Cardiovascular training|The cardiovascular training group will receive their usual therapy plus 3 days of 30 minutes of exercise per week. This program will last for 6 weeks while the participant is in the hospital. The cardiovascular training program will include pushing and pulling on pulleys, wheeling over mats, punching a boxing bag, and using an arm ergometer. The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital.
12007721|NCT00535210|Behavioral|Balance training|The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital. The balance training program will include sitting on mats - moving arm support from in front of the body to behind body, moving from sitting to lying and back up, and catching soft foam ball thrown directly to centre of chest and throwing it back.
12007775|NCT00534794|Drug|Pataday|Pataday QD for 2 days
12007722|NCT00535197|Biological|Infusion of autologous CD34+ stem cells into middle cerebral artery|intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
12007723|NCT00535158|Drug|Ergocalciferol (Vitamin D 2)|50,000units once weekly for 8 weeks then every other week for 4 weeks
12007724|NCT00535145|Drug|Treatment as usual (TAU), Paliperidone ER|Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
12007725|NCT00535132|Drug|Oral Risperidone|4 or 6 mg MG once daily for 0-2 weeks
12007726|NCT00535132|Drug|Paliperidone ER|6, 9 or 12 MG once daily for 4-6 weeks
12007727|NCT00535119|Drug|Carboplatin|Given IV
12007728|NCT00535119|Other|Laboratory Biomarker Analysis|Correlative studies
12007729|NCT00535119|Drug|Paclitaxel|Given IV
12007730|NCT00535119|Other|Pharmacological Study|Correlative studies
12007731|NCT00535119|Drug|Veliparib|Given PO
12007732|NCT00535106|Device|Automated external defibrillator (Philips FR2+ AED)|Patients in this arm will be provided with immediate defibrillatory shock coupled with otherwise standard resuscitative efforts.
12007733|NCT00535106|Device|SmartCPR|Patient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient.
12007734|NCT00535106|Other|Delayed defibrillation|In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation.
12007735|NCT00535093|Device|rapid streptococcal testing|Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture
12007736|NCT00535080|Drug|Metvix (methyl aminolevulinate)|Metvix (methyl aminolevulinate) (MAL), Photodynamic Therapy (PDT), cream, 160 mg/g. MAL cream will be applied for 3 hours then will be removed. The target area will then be exposed to red light (using a large-field LED light source: Aktilite 128) for 7 to 10 minutes at a dosage of 37 J/cm².
12007737|NCT00535067|Behavioral|Questionnaire|Questionnaires taking 60 minutes total to complete.
12007738|NCT00535054|Drug|Tears Again|Liposome Eye Spray
12007739|NCT00535041|Drug|Chemotherapy, radiation therapy & surgery|radiation and chemotherapy
12007740|NCT00535028|Drug|AER 001|AER 001 25 mgs s.c. once daily for 28 days
12007741|NCT00535028|Drug|placebo|sterile saline
12007742|NCT00535015|Drug|Betamarc|2 tabs BID
12007743|NCT00535002|Drug|Yohimbine|Participants were pre-treated with either yohimbine or placebo.
12007744|NCT00535002|Drug|Placebo|
12007745|NCT00534989|Procedure|FDG PET|FDG PET
12007746|NCT00534976|Drug|Comparator: montelukast sodium|"Patients 4-5 years: 4 mg Montelukast chewable tablet daily
~Patients 6-14 years: 5 mg chewable tablet daily"
12007747|NCT00534976|Drug|Comparator: Comparator: placebo (unspecified)|"Patients 4-5 years: 4 mg Pbo chewable tablet daily
~Patients 6-14 years: 5 mg Pbo chewable tablet daily"
12007748|NCT00534963|Procedure|cervical vs. uterine placement of balloon catheter|
12007749|NCT00534950|Radiation|5 vs 6 weekly fraction of RT|Chemotherapy
12007750|NCT00534937|Procedure|Compression wrapping|Short-stretch compression wrap will be applied at least once a week.
12007751|NCT00534937|Procedure|Flexitouch compression pump|In addition to short-stretch wrapping, this group will received once-daily Flexitouch compression pump, both at home and during the once-a-week clinic visits.
12007752|NCT00534924|Drug|Vit C|
12007753|NCT00534924|Procedure|Postconditioning|
12007754|NCT00534924|Other|no intervention|
12007755|NCT00534911|Behavioral|Cognitive Behavioral Therapy|"Participants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.
~Other Name: Primary and secondary coping enhancement training (PASCET)"
12007756|NCT00534911|Behavioral|Supportive Non-directive Therapy (SNDT)|SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.
12007757|NCT00534898|Drug|Bexarotene|
12007758|NCT00534898|Drug|Fenretinide|
12007759|NCT00534898|Drug|Placebo|
12007760|NCT00534885|Biological|Healive® Lot 1|Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
12007761|NCT00534885|Biological|Healive® Lot 2|Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
12007762|NCT00534885|Biological|Healive® Lot 3|Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
12007763|NCT00534885|Biological|Havrix|Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart
12007764|NCT00534872|Drug|SB-649868|10 mg
12007765|NCT00534859|Device|High Risk PCI|High Risk Percutaneous Coronary Intervention
12007766|NCT00534846|Drug|toremifene|The medication is given in tablet form, and the participants are instructed to take one tablet daily from cycle day 15 until the next menstruation. The active (toremifene 20 mg) and control (placebo) tablets were identical in appearance.
12007767|NCT00534846|Drug|placebo|tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
12007768|NCT00534833|Biological|DTaP-HB-PRP~T vaccine|0.5 mL, Intramuscular
12007769|NCT00534833|Biological|Tritanrix-HepB/Hib™|0.5 mL, Intramuscular
12007770|NCT00534833|Biological|Oral Polio Vaccine|0.5 mL, Oral
12007771|NCT00534820|Procedure|Cytogenetic Analysis of Bone Marrow Specimen|Cytogenetic Analysis of BM Specimen
12007772|NCT00534807|Drug|Vinflunine|
12007777|NCT00534781|Procedure|Mechanical Surgical Debridement|Surgical Debridement of the Achilles
12007778|NCT00534768|Procedure|active debridement|debridement on 1st, 3-5th and 7th postoperative days
12007779|NCT00534768|Procedure|control group|Postoperative debridement on 7th postoperative day
12007780|NCT00534755|Other|Breast Cancer database|prospective breast cancer database
12007781|NCT00534729|Drug|Weekly Carboplatin & Taxol w/concurrent RT|Chemotherapy
12007782|NCT00534703|Genetic|AAV1/SERCA2a|AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles)
12007783|NCT00534703|Drug|Placebo|Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion.
12007784|NCT00534690|Procedure|One-Lung ventilation|Low Vt, High PEP
12007785|NCT00534690|Procedure|One-Llung ventilation|High Vt, low PEP
12007786|NCT00534677|Drug|Terlipressin|2 mg stat & then 1 mg q6h iv and Placebo of Octreotide
12007787|NCT00534677|Drug|Octreotide|Octreotide 50mcg/hr infusion & a placebo of Terlipressin
12007788|NCT00534664|Device|TheraBionic device|Daily outpatient treatment with theraBionic device
12007789|NCT00534651|Drug|Paracetamol|Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.
12007790|NCT00534638|Biological|Cervarix|Intramuscular injection, 3 doses
12007791|NCT00534638|Biological|Engerix-B|Intramuscular injection, 3 doses
12007792|NCT00534625|Drug|zileuton|Single injection of zileuton 150 mg
12007793|NCT00534625|Drug|placebo|Single injection of placebo
12007794|NCT00534625|Drug|zileuton|Single injection of zileuton 300 mg
12007795|NCT00534612|Procedure|aspiration biopsy|fine needle aspiration biopsy of the parotid gland masses
12007796|NCT00534599|Drug|Placebo|oral
12007797|NCT00534599|Drug|quetiapine fumarate XR|oral
12007798|NCT00534586|Drug|Propofol|TCI 0.5 mcg/ml 1.0 mcg/ml
12007799|NCT00534586|Drug|Remifentanil|continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min
12007800|NCT00534586|Drug|S-Ketamine|continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h
12007801|NCT00534586|Drug|Sevoflurane|via face mask 0.40 Vol% 0.80 Vol%
12007802|NCT00534573|Drug|Amisulpride, Moclobemide|Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
12007803|NCT00534560|Drug|Tonabersat|Tablets, 4 week dose titration and 16 weeks treatment at target dose of 40 mg per day
12007804|NCT00534560|Drug|Tonabersat|Tablets: 4 week titration and 16 weeks at target dose of 80 mg per day
12007805|NCT00534560|Drug|Placebo|Tablets; 4 week dose titration with 16 weeks at target dose
12007806|NCT00534547|Procedure|Duodenal Exclusion|duodenal-jejunal bypass
12007807|NCT00534534|Behavioral|Repeated behavioural intervention without any drugs|"All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion as those in the standard group. No drugs will be used as part of the intervention. They also will undergo repeated interventions at outpatient visits at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period."
12007808|NCT00534521|Device|Posterior Tibial Nerve Device|The PTNS device (Urgent® PC) is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve (PTNS). It is a combination of a stimulator and a lead set. The stimulator is a battery powered, external pulse generator and is designed, constructed, and manufactured for multiple use in conjunction with the lead set. The lead set (comprised of the lead wires, needle electrode, and alcohol pad) transfers the electrical current from the stimulator to the tibial nerve via the needle electrode. The tibial nerve travels up the leg to the sacral nerve plexus which regulates the bladder and pelvic floor function.
12007809|NCT00534521|Device|Sham|This 2- piece needle, comprised of a needle handle and blunt-tip shaft feels like a slight prick when touched to the skin. However the shaft retracts as it appears to enter the skin but the skin is not punctured. The Streitberger needle specifically activates the dorsolateral prefrontal cortex, which is associated with the placebo effect.
12007810|NCT00534508|Drug|Tacrolimus Ointment 0.1%|Twice daily, 14 days treatment
12007811|NCT00534495|Biological|Rilonacept|2.2 mg/kg subcutaneously
12007812|NCT00534482|Behavioral|Enhanced Office|Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
12007813|NCT00534482|Behavioral|Conventional Office|Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
12007814|NCT00534482|Behavioral|AIM-HI program with enhanced feedback|Patient receives feedback on two novel indicators of their individual cardiovascular risk that: 1)appear to relate to obesity and lack of physical activity, and 2) may show relatively rapid change with improvements in these areas. These are the Homeostatic Assay - Insulin Resistance or HOMA-IR and Nuclear Molecular Resonance (NMR) lipoprotein profiles (NMRLP). These patients and their physicians also will receive periodic feedback on other outcome measures, including BMI, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
12007815|NCT00534482|Behavioral|AIM-HI program and regular feedback|Patients will not receive feedback on two specific cardiovascular risk indicators (ie, Homeostatic Assay - Insulin Resistance, Nuclear Molecular Resonance lipoprotein profiles). However, patients will receive feedback on Body Mass Index, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
12007816|NCT00534469|Biological|aldesleukin|
12007817|NCT00534469|Biological|filgrastim|
12007818|NCT00534469|Drug|busulfan|
12007819|NCT00534469|Drug|cytarabine|
12007820|NCT00534469|Drug|etoposide|
12007821|NCT00534469|Drug|idarubicin|
12007822|NCT00534469|Procedure|autologous hematopoietic stem cell transplantation|
12007823|NCT00534469|Procedure|bone marrow transplantation|
12007824|NCT00534469|Procedure|peripheral blood stem cell transplantation|
12007825|NCT00534469|Radiation|total-body irradiation|
12007826|NCT00534456|Drug|Placebo|Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group.
12007827|NCT00534456|Drug|Darbepoetin alfa|Starting dose: 0.75 mcg/kg subcutaneously Q2W. Subsequent doses: Darbepoetin alfa group to receive darbepoetin alfa titrated to achieve Hb target of 13.0 g/dL, not to exceed 14.5 g/dL.
12007828|NCT00534443|Procedure|Endoscopy of upper GI tract|"Upper GI endoscopy, one time on diagnosis and a second time 15 days after the end of the treatment. Gastric juice will be aspirated immediately after the entrance of the endoscope into the gastric lumen. Four biopsy specimens will be obtained from adjacent areas of the gastric antrum. Each biopsy will be used for in vitro culture. Blood will be sampled from one antecubital vein under aseptic conditions.
~Each patient will be given antisecretory treatment and - if necessary- eradication treatment of H. pylori according to international guidelines."
12007829|NCT00534430|Drug|busulfan|
12007830|NCT00534430|Drug|cyclosporine|
12007831|NCT00534430|Drug|etoposide|
12007832|NCT00534430|Drug|mycophenolate mofetil|
12007833|NCT00534430|Procedure|allogeneic bone marrow transplantation|
12007834|NCT00534430|Procedure|allogeneic hematopoietic stem cell transplantation|
12007835|NCT00534430|Procedure|peripheral blood stem cell transplantation|
12007836|NCT00534430|Radiation|total-body irradiation|
12007837|NCT00534417|Drug|capecitabine|Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight < 80 Kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 Kg.
12007838|NCT00534417|Drug|fulvestrant|Fulvestrant will be given at 500mg on Day 1 followed by 250 mg on Days 15 and 29, then 250mg every 28 days(Q28d).
12007839|NCT00534404|Drug|Nicotine patches|Participants will wear nicotine patches.
12007840|NCT00534404|Behavioral|Telephone counseling|Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
12007841|NCT00534404|Behavioral|iQuit Smoking website|Participants will access the Project Quit (iQuit Smoking) website.
12007842|NCT00534391|Drug|neomycin sulfate, polymyxin B sulfate and gramicidin|to the effected eye 4 times a day
12007843|NCT00534391|Drug|Artificial tear|4 times daily
12007844|NCT00534378|Drug|Midazolam|The study drug was administered IM into the anterior thigh using the preloaded autoinjector. The autoinjectors were preloaded with midazolam 5 mg or 10 mg with a total volume of 1 or 2 mL. Healthy subjects were assigned to one of six target dosage groups (0.10, 0.18, 0.25, 0.33, 0.40, 0.49 mg/kg) and, based on their weight, received the necessary combination of fixed 5 or 10 mg doses to provide the assigned target dose.
12007845|NCT00534365|Device|tension-free vaginal tape|Retropubic mid-urethral sling
12007846|NCT00534365|Device|TVT-SECUR device|Mid-urethral mini-sling
12007847|NCT00534352|Drug|TMC125; darunavir; ritonavir|TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks
12007848|NCT00534339|Device|Easyband (Telemetrically adjustable gastric banding device)|EasyBand
12007849|NCT00534326|Procedure|Standard Reaming|Femoral reaming using standard reaming techniques of multiple reamers
12007850|NCT00534326|Procedure|Reaming/Irrigating/Aspirating|Reaming using the Reamer/Irrigator/Aspirating
12007851|NCT00534313|Drug|Abatacept|Solution, intravenous, monthly, short-term = 24 weeks (6 months)
12007852|NCT00534313|Drug|Placebo|Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
12007853|NCT00534300|Drug|Omegaven|Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)
12007854|NCT00534300|Drug|Isotonic saline|Intravenous infusion, 100 mL, 25mL/h
12007855|NCT00534287|Drug|meropenem|Empirical antibiotic therapy with 3 x 1 g intravenous meropenem. Dosage is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
12007856|NCT00534287|Drug|meropenem, moxifloxacin|Empirical antibiotic therapy with 3 x 1 g intravenous meropenem plus 1 x 400 mg intravenous moxifloxacin. Dosage of meropenem is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
12007857|NCT00534274|Other|3'-deoxy-3'-[18F]fluorothymidine|
12007858|NCT00534261|Drug|Interferon beta-1a|IM injection
12007859|NCT00534248|Biological|Zoster Vaccine, Live (Zostavax™)|A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
12007860|NCT00534248|Biological|Comparator: Placebo|A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.
12007861|NCT00534235|Procedure|Decompression|Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
12007862|NCT00534235|Device|Posterolateral Fusion and Implantation of Pedicle Screws|
12007863|NCT00534235|Device|Implantation of coflex Interlaminar Technology|
12007864|NCT00534209|Biological|Allogeneic B7.1/HLA-A1|Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally
12007865|NCT00534209|Other|Placebo|Given intradermally
12007866|NCT00534196|Radiation|Permanent iodine-125 (Brachytherapy)|Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
12007867|NCT00534183|Drug|Olanzapine|Olanzapine in dose range of 10-20mg
12007868|NCT00534183|Drug|Risperidone|Risperidone 1-6mg
12007869|NCT00534183|Drug|Haloperidol|Haloperidol 10-20mg
12007870|NCT00534170|Dietary Supplement|Probiotic (Yakult)|It is a dietary supplement ,65 ml containing 15 billion lactobacillus
12007871|NCT00534144|Drug|iron sucrose injection, USP|iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
12007872|NCT00534144|Drug|sodium ferric gluconate complex in sucrose injection|sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks
12007873|NCT00534131|Procedure|Standard abdominal approach for rectal excision|Standard abdominal approach for rectal excision
12007874|NCT00534131|Procedure|APPEAR Procedure|Perineal incision to reach the distal rectum
12007875|NCT00534131|Procedure|Proctectomy|standard rectal excision which does not preserve the anal canal
12007876|NCT00534118|Biological|donor lymphocytes|Given IV
12007877|NCT00534105|Other|Total Cholesterol|
12007878|NCT00534105|Other|Triglyceride|
12007879|NCT00534105|Other|HDL|
12007880|NCT00534105|Other|LDL|
12007881|NCT00534092|Device|X STOP® Interspinous Process Decompression System|The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly.
12007882|NCT00534079|Drug|Dornase alfa (Pulmozyme)|1 x 2,5 ml per day, inhalation use, for 28 days
12007883|NCT00534079|Drug|isotonic saline|1 x 2,5 ml per day, inhalation use, for 28 days
12007884|NCT00534053|Other|Mailed Educational Reminder|1 page educational reminder that reminds the patient to return their FOBT cards back to the VA laboratory. In addition, it also contains reasons why colon cancer screening is important.
12007885|NCT00534027|Drug|AMG 655|AMG 655 is a monoclonal antibody directed against TR-2.
12007886|NCT00534027|Other|AMG 655 placebo|Inactive dummy AMG 655 (to maintain blind)
12007887|NCT00534014|Dietary Supplement|Vitamin C|Arm A = 0 mg Vitamin C, Arm B = 250 mg Vitamin C, Arm C = 500 mg Vitamin C, Arm D = 1000 mg Vitamin C
12007888|NCT00534001|Drug|bupropion hydrochloride|Given orally
12007889|NCT00534001|Other|placebo|Given orally
12007890|NCT00533988|Device|Antimicrobial impregnated catheter (5593)|Comparison of 14-day placement of a standard triple lumen (ARROW Standard Triple Lumen Catheter, Arrow International Inc., Reading, PA, US) versus an antimicrobial impregnated catheter (Chlorhexidine-silver sulfadiazine)(ARROWgard Triple Lumen Catheter, Arrow International Inc., Reading, PA, US)
12007891|NCT00533962|Drug|Anterior Juxtascleral Depot of Anecortave Acetate|
12007892|NCT00533949|Biological|Cetuximab|Loading dose: 400 mg/m2, IV, one week prior to start of radiation therapy (RT). Then, beginning day 1 of RT, 250 mg/m2, IV, weekly; for 60 Gy arm for 15 weeks, for 74 Gy arm for 16 weeks.
12007893|NCT00533949|Drug|Carboplatin|"Concurrent: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy; for 74 Gy arms, on day 43 as well.
~Consolidation, 3 weeks after completion of RT, AUC=6, IV, days 1 and 22."
12007894|NCT00533949|Drug|Paclitaxel|"Concurrent: 45 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy (RT); for 74 Gy arms, on day 43 as well.
~Consolidation, 3 weeks after completion of RT, 200 mg/m2, IV, days 1 and 22."
12007895|NCT00533949|Radiation|60 Gy RT|Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.
12007896|NCT00533949|Radiation|74 Gy RT|Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.
12007897|NCT00533936|Biological|trastuzumab|
12007898|NCT00533936|Drug|cyclophosphamide|
12007899|NCT00533936|Drug|doxorubicin hydrochloride|
12007900|NCT00533936|Drug|fluorouracil|
12007901|NCT00533936|Drug|paclitaxel|
12007902|NCT00533936|Procedure|adjuvant therapy|
12007903|NCT00533936|Procedure|conventional surgery|
12007904|NCT00533936|Procedure|neoadjuvant therapy|
12007905|NCT00533923|Drug|Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF|intravenous
12007906|NCT00533910|Drug|Rifaximin|550mg BID rifaximin for 8 weeks
12007907|NCT00533910|Drug|placebo|same as the experimental arm
12007908|NCT00533897|Drug|Abatacept|Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term)
12007909|NCT00533897|Drug|Placebo|Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)
12007910|NCT00533884|Other|Assessment of therapy complications|Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
12007911|NCT00533884|Other|Neurocognitive assessment|Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
12007912|NCT00533884|Other|Quality-of-life assessment|Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment
12007913|NCT00533858|Drug|lacidipine (4 mg) or losartan (50 mg)|lacidipine (4 mg) or losartan (50 mg), both given once daily at the same hour in the morning (approximately at 8 AM) for 12 weeks
12007914|NCT00533845|Drug|On-Q Pain Pump|Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
12007915|NCT00533832|Device|vagus nerve stimulation (VNS)|"intermittent vagus nerve stimulation
~Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase."
12007916|NCT00533819|Other|6 months of healthy physical activity|half an hour of healthy physical activity including 20 minutes aerobic, 5 minutes warm up and cool down, 4 days a week
12007917|NCT00533806|Behavioral|Cognitive Behavior Therapy|CBT includes 12 treatment sessions over 14 weeks. The sessions deliver family-based exposure with response prevention. Participants assigned to receive CBT will learn skills to help control OCD. CBT sessions will also include education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management.
12007918|NCT00533806|Behavioral|Relaxation Therapy|Relaxation therapy includes 12 sessions delivered over 14 weeks. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing.
12007919|NCT00533793|Procedure|open fracture reduction|internal fracture fixation: osteosynthesis plates or intra-medullary nails
12007920|NCT00533780|Procedure|Healing Touch|
12007921|NCT00533754|Procedure|drawing blood|
12007922|NCT00533741|Drug|Aluminum hydroxide|Adjuvant; administered with SARS-CoV vaccine.
12007923|NCT00533741|Drug|Placebo|Saline for injection.
12007924|NCT00533741|Biological|SARS-CoV|Whole-virus vaccine, grown in certified Vero cells and doubly inactivated by treatment with formalin and ultraviolet light (UV). Supplied in liquid formulation in single dose vials with and without aluminum hydroxide as an adjuvant. Doses supplied without aluminum hydroxide will be 2.5, 5.0 and 10.0 mcg. Doses supplied with aluminum hydroxide adjuvant will be 2.5 and 5.0 mcg.
12007925|NCT00533728|Drug|Soluble beta-glucan (SBG)|
12007926|NCT00533702|Biological|IMC-1121B (ramucirumab)|10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
12007927|NCT00533702|Drug|Dacarbazine|1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
12007928|NCT00533689|Procedure|Electroretinography (ERG), Visual Evoked Potentials (VEP)|
12007929|NCT00533676|Drug|MK0524A, /Duration of Treatment : 8 Weeks|
12007930|NCT00533676|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks|
12007931|NCT00533663|Procedure|Healing Touch|every other week (during their infusion)
12007932|NCT00533663|Drug|Standard care|
12007933|NCT00533663|Drug|guided relaxation|
12007934|NCT00533650|Drug|MK0429|
12007935|NCT00533637|Drug|Cetirizine dihydrochloride (10 mg/ml) liposomal formulation|2x110μL in each nostril twice daily for 7 days
12007936|NCT00533637|Drug|Cetirizine dihydrochloride (10 mg/ml) buffer solution|2x110μL in each nostril, as a single dose
12007937|NCT00533637|Drug|Placebo|Citrate buffer with preservatives
12007938|NCT00533624|Drug|Mycophenolate Sodium Delayed Release Tablets|Myfortic® 1,440 mg/day
12007939|NCT00533624|Drug|Mycophenolate Mofetil|Cellcept® 2,000 mg/day
12007940|NCT00533611|Drug|MK0524A, /Duration of Treatment : 4 Weeks|
12007941|NCT00533611|Drug|Comparator : niacin /Duration of Treatment : 1 Weeks|
12007942|NCT00533598|Drug|MK0557|
12007943|NCT00533585|Drug|BAY 43-9006|Starting Dose of 200 mg orally twice a day on Day 3 through Day 19 of Cycle 1 and Days 2 through 19 of Cycle 2 and remaining cycles. Cycle is 21 days.
12007944|NCT00533585|Drug|Paclitaxel|200 mg/m^2 By Vein Over 3 Hours on Day 1.
12007945|NCT00533585|Drug|Carboplatin|Area under curve (AUC) 6 By Vein Over 30 Minutes on Day 1.
12007946|NCT00533585|Drug|Bevacizumab|Starting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.
12007947|NCT00533559|Drug|sodium phenylbutyrate|buphenyl, 7.5 gm/day for two weeks for two studies, one with saline and one admission with intralipid and heparin
12007948|NCT00533559|Drug|Placebo|Placebo comparator
12007949|NCT00533546|Drug|Activated Protein C|Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset
12007950|NCT00533533|Drug|docetaxel, oxaliplatin|"Oxaliplatin will be administered in combination with docetaxel as a first-line chemotherapy in advanced gastric cancer patients. Each cycle is repeated every 3 weeks.
~Docetaxel Oxaliplatin Level 1 60 mg/m2/day 1 100 mg/m2/day 1 Level 2 75 mg/m2/day 1 100 mg/m2/day 1 Level 3 75 mg/m2/day 1 130 mg/m2/day 1"
12007951|NCT00533520|Drug|ranibizumab|Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days
12007952|NCT00533507|Biological|Synflorix|Intramuscular injection, 3 doses.
12007953|NCT00533507|Biological|Infanrix hexa|Intramuscular injection, 3 doses.
12007954|NCT00533507|Biological|Rotarix|Oral, 2 doses.
12007955|NCT00533494|Behavioral|physician feedback (A)|Feedback information to physicians
12007956|NCT00533481|Drug|MK0557|
12007957|NCT00533468|Drug|Lidocaine Cream 4%|Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
12007958|NCT00533455|Drug|Gabapentin|
12007959|NCT00533442|Drug|Rapamycin|Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
12007960|NCT00533442|Drug|Mycophenolate Mofetil|MMF 1 gm BID beginning 1st day postoperative day
12007961|NCT00533442|Drug|Tacrolimus|Part of standard maintenance.
12007962|NCT00533442|Drug|Steroids|Part of standard maintenance
12007963|NCT00533429|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily until disease progression
12007964|NCT00533429|Drug|pemetrexed|500 mg/m2, IV, day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
12007965|NCT00533429|Drug|carboplatin|AUC 6, IV day 8 cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
12007966|NCT00533429|Drug|bevacizumab|15 mg/kg, IV, Day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
12007967|NCT00533429|Drug|Placebo|oral, daily
12007968|NCT00533416|Drug|ON 01910 Na|
12007969|NCT00533403|Drug|MK0686|
12007970|NCT00533390|Drug|efavirenz|600mg X 800mg QID during TB therapy with rifampicin associated with other antituberculosis drugs in patients concomitant treated for tuberculosis and AIDS
12007971|NCT00533377|Drug|CP-533, 536|Active study drug
12007972|NCT00533377|Drug|Placebo|Placebo vehicle
12007973|NCT00533377|Procedure|Standard of Care|Standard surgical procedure
12007974|NCT00533377|Drug|CP-533,536|Active study drug
12007975|NCT00533377|Drug|CP-533,536|Active study drug
12007976|NCT00533377|Drug|CP-533,536|Active study drug
12007977|NCT00533364|Drug|SBG (Soluble beta-glucan)|Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles.
12007978|NCT00533351|Drug|AGN201781|AGN201781 50 mg capsules three-times daily for 2 weeks
12007979|NCT00533351|Drug|placebo|placebo 50 mg capsules three-times daily for 2 weeks
12007980|NCT00533338|Behavioral|Weight Gain Prevention Program|Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling.
12007981|NCT00533338|Behavioral|Questionnaire|Packet of questionnaires will be completed.
12007982|NCT00533312|Drug|Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks|
12007983|NCT00533312|Drug|MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks|
12007984|NCT00533312|Drug|Comparator : niacin / Duraton of Treatment: 4 Weeks|
12007985|NCT00533299|Drug|Hydralazine and magnesium valproate|Hydralazine and valproate will start from seven days before day 1 of chemotherapy until the end of the sixth course. Hydralazine will be administered at 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/Kg t.i.d.
12007986|NCT00533299|Drug|Placebo|Placebos will start from seven days before day 1 of chemotherapy until the end of the sixth course. Placebo tablets will be administered in an identical form that experimental drugs.
12007987|NCT00533286|Drug|benzodiacepine|diazepam (2 x 5 mg/ die)
12008023|NCT00532961|Drug|Dexamethasone 0.1% and tobramycin 0.3%|ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.
12007988|NCT00533273|Biological|collagenase clostridium histolyticum|Subjects could have received up to three injections of AA4500 0.58 mg/placebo into the cord of the affected hand in the double-blind phase. In the open-label extension phase, subjects could have received up to five additional injections of AA4500, with each injection separated by at least 30 days. Individual joints could have received up to a maximum of three AA4500 injections.
12007989|NCT00533247|Drug|Celecoxib|
12007990|NCT00533234|Device|ExploR® Modular Radial Head|The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.
12007991|NCT00533221|Drug|somatotropin|0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
12007992|NCT00533221|Drug|Placebo|0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
12007993|NCT00533208|Drug|MK0524|
12007994|NCT00533195|Drug|5-Methoxypsoralen|1,2 mg/kg 2 hours before UVA irradiation p.o. 3 times weekly for 5 weeks
12007995|NCT00533195|Device|UVA1 phototherapy|"Treatment 5 x week for 3 weeks (=15 irradiations). Determination of the UVA 1 MED prior to treatment. Start with 1 MED. Increments of the UVA 1 dose in 20 % steps until a maximal dose of 70 J/cm2 in the absence of an erythemal reaction and by good tolerability.
~No maintenance therapy except emollients."
12007996|NCT00533169|Drug|ZD6474|Part A = Starting dose 50 mg/m^2 by mouth daily for 28 days; Part B, C = Starting dose 50 mg/m^2 by mouth daily on days 2-28.
12007997|NCT00533169|Drug|Retinoic Acid|Part B, C = 80 mg/m^2 by mouth twice daily for 2 consecutive weeks out of every four weeks (28 days).
12007998|NCT00533156|Device|Vascular access site closure (7F Ensure)|
12007999|NCT00533143|Other|non invasive ventilation (NIV)|NIV is a form of mechanical ventilation delivered through a face or nasal mask and therefore not requiring endotracheal intubation. It will be delivered according to the compliance and tolerance of the patients.
12008000|NCT00533130|Procedure|clinical evaluation|analyze the x ray from each patient and evaluate the treatment y development of bone healing.
12008001|NCT00533130|Procedure|observational study|evaluate the walk patron, bone healing and range of motion at 1,3,6,12 months
12008002|NCT00533117|Drug|Fluoxetine|Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
12008003|NCT00533117|Behavioral|Dialectical Behavior Therapy|Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
12008004|NCT00533117|Behavioral|Supportive psychotherapy|Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
12008005|NCT00533104|Procedure|BM-MNC preparation|"For autologous bone marrow - mononuclear cells preparation, 500ml of bone marrow are collected under general anaesthesia; mononuclear cells are separated using a blood-cells separator (COBE SPECTRA, GAMBRO BCT) and concentrated to produce a final volume of 40ml.
~Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection)."
12008006|NCT00533104|Procedure|PB-MNC preparation|"Peripheral blood - mononuclear cells are collected through cytapheresis with the same blood-cells separator which is adjusted to obtain a 40 mL cell product. No previous mobilization with hematopoïetic growth-factor is administered.
~Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection)."
12008007|NCT00533091|Biological|MEDI-545|"MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial.
~Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."
12008008|NCT00533091|Other|Placebo|"Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial.
~Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 12 weeks.
~Thereafter, subjects will receive MEDI-545, at the dose specified in the dose cohort they are assigned, every 2 weeks for an additional 12 weeks."
12008009|NCT00533078|Dietary Supplement|omegaven|Trial participants are prescribed TPN by the attending physician as soon as indicated, which will be administered via a central venous line over a time period of approximately 20 hours per day. The formulation given to all patients is Nutriflex lipid spezial®, an emulsion containing the full supply of carbohydrates, amino acids and lipids (SO:MCT = 1:1) with a total energy content of 2215 kcal in a 1875 ml volume, see Investigator's Brochure. In addition, they receive daily infusional Omegaven® 100 ml over 4 hours, which equal FO 10 g/d or omega-3 PUFA 3-6 g/d.
12008010|NCT00533065|Drug|Donepezil|week1 - week12: 1 tablet per day (5mg) week13 - week52: 1 tablet per day (10mg)
12008011|NCT00533052|Behavioral|Affective and Cognitive Skills Training|24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training
12008012|NCT00533039|Drug|Varespladib (A-002)|250mg tablets BID for 3-5 days pre-angioplasty and 5 days post-angioplasty.
12008013|NCT00533039|Drug|placebo|250mg tablets BID 3-5 days pre-angioplasty and 5 days post-angioplasty.
12008014|NCT00533026|Drug|Duloxetine|
12008015|NCT00533026|Drug|Warfarin|
12008016|NCT00533013|Other|Usual Care|Management of heart failure is provided by primary practitioners and consultant cardiologists
12008017|NCT00533013|Other|Disease Management and Tele-Monitoring|Management of heart failure is provided by cardiologists at regional heart failure clinics and by nurse practitioners at regional heart failure clinics and a designated call center. Decisions on treatment are guided by designated protocols and information derived for tele-monitoring of blood pressure, body weight and pulse rate.
12008018|NCT00533000|Procedure|Smoking cessation|Weekly smoking cessation by professional counseling and nicotine substitute on request
12008019|NCT00532987|Behavioral|Questionnaire|Questionnaire form to be completed by patient
12008020|NCT00532974|Biological|EP1090|Low dose
12008021|NCT00532974|Biological|EP1090|High dose
12008022|NCT00532961|Drug|Loteprednol etabonate 0.5% and tobramycin 0.3%|ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days
12008117|NCT00532246|Drug|Placebo|
12008024|NCT00532948|Drug|capecitabine [Xeloda]|500mg/m2 po bid (starting dose)
12008025|NCT00532935|Drug|sitagliptin phosphate (+) metformin hydrochloride|sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
12008026|NCT00532935|Drug|Comparator: pioglitazone|pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
12008027|NCT00532909|Drug|Vandetanib|100mg or 300mg By mouth every day continuous
12008028|NCT00532909|Drug|Capecitabine|Dosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.
12008029|NCT00532909|Drug|Oxaliplatin|dosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.
12008030|NCT00532909|Drug|Bevacizumab|Dosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle)
12008031|NCT00532883|Drug|Hydroxyurea|HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
12008032|NCT00532883|Drug|Magnesium Pidolate|HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months)
12008033|NCT00532883|Other|Placebo Pills and Placebo Liquid|HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
12008034|NCT00532870|Other|laparoscopic|
12008035|NCT00532857|Drug|Paclitaxel/Gemcitabine/Trastuzumab|80 mg/m2 of paclitaxel 1,200 mg/m2 of gemcitabine, day 1, day 8 every 3-week. trastuzumab at a dose of 4 mg/kg IV on D1 of first treatment cycle subsequently given weekly at a dose of 2 mg/kg
12008036|NCT00532844|Drug|6R-BH4 (sapropterin dihydrochloride)|5 mg/kg BID of 6R-BH4 tablets to be administered orally for 13.5 days
12008037|NCT00532844|Drug|6R-BH4 (sapropterin dihydrochloride)|5 mg/kg BID of 6R-BH4 tablets, plus 500 mg BID of Vitamin C caplets to be administered orally for 13.5 days
12008038|NCT00532818|Drug|Hydralazine and magnesium valproate|Cisplatin + Topotecan plus hydralazine valproate
12008039|NCT00532818|Drug|Placebo|Cisplatin + Topotecan plus placebo
12008040|NCT00532792|Biological|A/H5N1|Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
12008041|NCT00532792|Biological|A/H5N1|Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
12008042|NCT00532792|Biological|A/H5N1|Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
12008043|NCT00532792|Biological|A/H5N1|Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
12008044|NCT00532792|Biological|A/H5N1|Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
12008045|NCT00532792|Biological|A/H5N1|Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
12008046|NCT00532792|Biological|A/H5N1|High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
12008047|NCT00532792|Biological|A/H5N1|High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
12008048|NCT00532792|Biological|A/H5N1|High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
12008049|NCT00532792|Biological|Placebo|Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
12008050|NCT00532779|Drug|Naltrexone SR 16 mg/Bupropion SR 360 mg /day|
12008051|NCT00532779|Drug|Naltrexone SR 32 mg/Bupropion SR 360 mg /day|
12008052|NCT00532779|Drug|Placebo|
12008053|NCT00532779|Behavioral|Ancillary therapy|Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
12008054|NCT00532766|Drug|Jusline|
12008055|NCT00532753|Behavioral|Community Empowerment|
12008056|NCT00532740|Radiation|Yttrium Y 90 glass microspheres|Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.
12008057|NCT00532727|Drug|Carboplatin|AUC 6 every 3 weeks for six cycles (18 weeks)
12008058|NCT00532727|Drug|Docetaxel|100mg/m2 every 3 weeks for six cycles (18 weeks)
12008059|NCT00532714|Drug|Irinotecan plus capecitabine|"Irinotecan 80 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period.
~Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period)."
12008060|NCT00532701|Drug|Peg-IFN + WB RBV for 16 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
~Rapid virologic response (RVR) at week 4 of therapy: achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 5-16"
12008061|NCT00532701|Drug|Peg-IFN + LD RBV for 16 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-6
~Rapid virologic response (RVR) at week 4 of therapy: achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 6-16"
12008062|NCT00532701|Drug|Peg-IFN + WB RBV for 24 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
~Rapid virologic response (RVR) at week 4 of therapy: not achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-24"
12008063|NCT00532701|Drug|Peg-IFN + WB RBV for 48 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
~Rapid virologic response (RVR) at week 4 of therapy: not achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-48"
12008064|NCT00532701|Drug|Peg-IFN + LD RBV for 24 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 1-24
~Rapid virologic response (RVR) at week 4 of therapy: both achieved and not achieved"
12008065|NCT00532688|Drug|N-acetylcysteine|28 days of oral n-acetylcysteine (500mg bd)(in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.
12008066|NCT00532675|Drug|LBH589|PAN 5 mg and PAN 20 mg capsules
12008067|NCT00532675|Combination Product|Lenalidomide|Lenalidomide 5mg or 25 mg
12008068|NCT00532662|Drug|S(+)-ketamine|epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
12008069|NCT00532636|Procedure|Ventilation|Mask ventilation in neutral and head extension position
12008070|NCT00532636|Procedure|Ventilation|Mask ventilation in neutral and head extension position
12008071|NCT00532623|Drug|Gemcitabine plus Vinorelbine|Gemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles
12008072|NCT00532623|Drug|Sequential|"Gemcitabine monotherapy followed by Vinorelbine monotherapy:
~-Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles."
12008073|NCT00532610|Drug|GSK189075|
12008074|NCT00532597|Procedure|On-line hemodiafiltration|
12008075|NCT00532597|Procedure|Low flux hemodialysis|
12008076|NCT00532584|Drug|Beclomethasone|The treatment with inhaled beclomethasone will be administered to Group A from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days
12008077|NCT00532571|Drug|CoQ10|
12008078|NCT00532558|Drug|Lapaquistat acetate|Lapaquistat acetate 50 mg, tablets, orally, once daily for up to 12 weeks.
12008079|NCT00532558|Drug|Placebo|Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks.
12008080|NCT00532545|Drug|Teriparatide|Teriparatide 20 micrograms/daily subcutaneously
12008081|NCT00532532|Drug|tolperisone HCl|Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
12008082|NCT00532532|Drug|tolperisone HCl|High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
12008083|NCT00532532|Drug|tolperisone HCl|Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
12008084|NCT00532519|Drug|citalopram (cipralex)|10-20 mg/day, for 12 weeks.
12008085|NCT00532506|Drug|SK-0403|
12008086|NCT00532493|Drug|prazosin|"Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
12008087|NCT00532493|Other|placebo|"sugar pill"
12008088|NCT00532480|Drug|Duloxetine|60 mg capsules
12008089|NCT00532467|Drug|SRX251|
12008090|NCT00532454|Drug|Tamoxifen|tamoxifen 20mg, PO, QD until disease progression
12008091|NCT00532441|Drug|Erlotinib|Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
12008092|NCT00532441|Drug|Docetaxel|Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
12008093|NCT00532428|Drug|Raloxifene|60 mg QD
12008094|NCT00532428|Drug|Raloxifene|120 mg QD
12008095|NCT00532428|Drug|Placebo|Placebo
12008096|NCT00532415|Drug|Triamcinolone Acetonide Injectable Suspension|Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
12008097|NCT00532389|Drug|LBH589|
12008098|NCT00532350|Drug|QAT370|
12008099|NCT00532350|Drug|Placebo|
12008100|NCT00532350|Drug|Tiotropium|
12008101|NCT00532337|Drug|ONO-5334|Placebo - 24/mos.
12008102|NCT00532337|Drug|ONO-5334|100mg QD /24 months
12008103|NCT00532337|Drug|ONO-5334|50mg BID /24 mos.
12008104|NCT00532337|Drug|ONO-5334|300mg QD /24 mos.
12008105|NCT00532337|Drug|ONO-5334|Alendronate 70mg once weekly / 24 mos
12008106|NCT00532324|Other|CA-MRSA Decolonization|In later stages of this study, women found to be nasally and/or vaginally colonized with CA-MRSA will be randomized to receive postpartum, either: 1) attempted decolonization with intranasal mupirocin twice a day for one to two weeks with or without diluted chlorhexidine or Clorox baths two to three times a week for one to two weeks or, 2) no intervention. The primary study is observational only.
12008107|NCT00532311|Drug|Lapaquistat acetate and stable statin therapy|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable statin therapy for up to 12 weeks.
12008108|NCT00532311|Drug|Stable statin therapy|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable statin therapy for up to 12 weeks.
12008109|NCT00532298|Biological|GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]|Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
12008110|NCT00532298|Biological|GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]|Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
12008111|NCT00532298|Biological|Fluarix [NH 2006/07 season]|Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
12008112|NCT00532298|Biological|Fluarix [NH 2007/08 season]|Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
12008113|NCT00532285|Drug|Paclitaxel/Gemcitabine|Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8).Patients will receive four cycles of therapy unless there is any evidence of no response (SD or PD) or unacceptable toxicity defined as unpredictable, irreversible, or Grade 4, or noncompliance by patient with protocol requirements.
12008114|NCT00532272|Drug|Letrozole ,Goserelin|Letrozole 2.5mg qd. Goserlin 3.6mg monthly(premenopausal)
12008115|NCT00532259|Drug|CT-011|IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
12008116|NCT00532246|Drug|raloxifene|
12008119|NCT00532220|Drug|Ibandronate IV|Ibandronate IV (Bonviva® IV), 10.5 mg divided in 4 single infusions within 2 weeks(1x1.5 mg, 3x3 mg), followed by a fifth infusion after 3 months (V4)
12008120|NCT00532220|Drug|Placebo|Placebo IV, divided in 4 single infusions within 2 weeks, followed by a fifth infusion after 3 months (V4)
12008121|NCT00532207|Drug|teriparatide|subcutaneous 20 micrograms
12008122|NCT00532194|Drug|cediranib|Once-daily oral tablet starting dose 20mg
12008123|NCT00532181|Behavioral|Savings Behavior and Consumer's Approach to Risk|
12008124|NCT00532168|Drug|tenofovir + emtricitabine + efavirenz|tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
12008125|NCT00532168|Drug|tenofovir + emtricitabine + lopinavir-ritonavir|tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
12008126|NCT00532168|Drug|tenofovir + emtricitabine + atazanavir-ritonavir|tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD
12008127|NCT00532155|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
12008128|NCT00532155|Drug|Placebo|Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
12008129|NCT00532155|Drug|Docetaxel (Taxotere®)|75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.
12008130|NCT00532155|Drug|Dexamethasone (pre- and post-medication for docetaxel)|As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).
12008131|NCT00532142|Drug|Intravitreal Triamcinolone|
12008132|NCT00532142|Procedure|Radial Optic Neurotomy|
12008133|NCT00532142|Other|Placebo - Sham Intravitreal Injection|
12008134|NCT00532129|Drug|Rituximab|375mg/m^2 IV on Day 1 of Cycle 1; 500mg/m^2 on Day 1 of Cycles 2-6.
12008135|NCT00532129|Drug|Chlorambucil|10 mg/m^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.
12008136|NCT00532116|Drug|EMSAM (Selegiline Transdermal System) 6mg|STS 6mg/24hr
12008137|NCT00532116|Drug|EMSAM (Selegiline Transdermal System) 12mg|EMSAm 12mg/24Hr
12008138|NCT00532090|Drug|RG4733|Administered orally daily at ascending doses to successive cohorts of patients
12008139|NCT00532090|Drug|RG4733|Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
12008140|NCT00532090|Drug|RG4733|Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
12008141|NCT00532077|Drug|rhPTH(1-34)|
12008142|NCT00532077|Drug|SB-751689 100 mg|
12008143|NCT00532077|Drug|SB-751689 400 mg|
12008144|NCT00532064|Procedure|Biospecimen Collection|Undergo collection of blood
12008145|NCT00532064|Other|Questionnaire Administration|Ancillary studies
12008146|NCT00532051|Device|OCT measurements|This study is about a new imaging method to study the front part of the eye. This imaging method is called Optical Coherence Tomography (OCT) which provides detailed cross-sectional (layered) views of structures in the eye. The OCT system scans a beam of light across the eye to take a picture. OCT provides a more detailed image than other imaging methods of the eye such as ultrasound, CT scan (computed tomography), and MRI (magnetic resonance imaging). In addition, OCT imaging does not touch the eye. OCT is routinely used in imaging structures in the back of the eye (retina) and cornea. This study uses high-speed FDA approved OCT systemsThe measurements from the OCT systems are used in selecting IOL power.
12008147|NCT00532038|Drug|ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)|Patients will apply ThermoProfen daily for approximately 12 hours for up to 12 months for treatment of the pain associated with osteoarthritis of the knee.
12008148|NCT00532025|Drug|Sorafenib|Sorafenib will be administered as oral formulation (200 mg tablets) at a dose of 400 mg twice daily starting 28 to 42 days after surgery or surgery plus adjuvant radiotherapy. The dose may be adjusted based on individual toxicities following a predetermined dose reduction schedule. Sorafenib therapy will be continued for 48 months, or until disease progression, patient refusal or intolerable toxicity, whichever comes first. Patients in remission after 48 months will be offered continued Sorafenib treatment in a roll-over study.
12008149|NCT00532012|Drug|RhuDex®|
12008150|NCT00531999|Drug|Raltegravir then lopinavir/ritonavir|raltegravir 400mg twice daily for first 14 days of study lopinavir/ritonavir 400/100mg twice daily for last 14 days of study
12008151|NCT00531999|Drug|Lopinavir/ritonavir then raltegravir|lopinavir/ritonavir 400 mg twice daily for the first 14 days of the study raltegravir 400mg twice daily for the last 14 days of the study
12008152|NCT00531986|Drug|Lopinavir-Monotherapy|Patients on triple HAART will be switched to LPV/r-monotherapy
12008153|NCT00531986|Drug|HAART|Patients will continued their current HAART
12008154|NCT00531973|Drug|liposomal doxorubicin|5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)
12008155|NCT00531973|Drug|epirubicin|5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)
12008156|NCT00531960|Drug|Erlotinib|150 mg, PO, daily
12008157|NCT00531960|Drug|Bevacizumab|15 mg/kg, IV, Day 1 of Cycles 1 through 7
12008158|NCT00531960|Drug|Standard platinum-based chemotherapy|At the discretion of the investigator
12008159|NCT00531947|Drug|Selegiline Transdermal System|EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
12008160|NCT00531947|Drug|Placebo|Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
12008161|NCT00531934|Drug|Doxycline|100mg po daily
12008162|NCT00531934|Drug|erlotinib [Tarceva]|150mg po daily
12008163|NCT00531908|Drug|furosemide|furosemide
12008164|NCT00531895|Drug|duloxetine|duloxetine 60 mg/d
12008165|NCT00531882|Drug|Pioglitazone|30 mg once a day
12008166|NCT00531882|Drug|Simvastatin|40 mg once a day
12008167|NCT00531882|Drug|Ibuprofen|Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
12008168|NCT00531869|Behavioral|biases towards products|
12008169|NCT00531856|Drug|Inhaled carbon monoxide|0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
12008170|NCT00531856|Drug|Inhaled carbon monoxide|2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
12008171|NCT00531856|Drug|Inhaled carbon monoxide|3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
12008172|NCT00531856|Drug|Inhaled Carbon Monoxide|3.5 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
12008173|NCT00531856|Drug|Inhaled Carbon Monoxide|2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant.
12008174|NCT00531843|Drug|fondaparinux sodium|fondaparinux 2.5mg SubQ daily for DVT prophylaxis to be started by treating physicians once deemed safe and to be discontinued once patient in discharged from the hospital or at discretion of treating physicians.
12008175|NCT00531843|Device|sequential compression devices|Sequential compression devices at all times during the patient's hospital admission will be used in patients who have a contraindication to pharmacologic DVT prophylaxis. This is already the current standard of care.
12008176|NCT00531817|Drug|Tocilizumab|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
12008177|NCT00531817|Drug|Placebo|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
12008178|NCT00531817|Drug|Permitted DMARDs|As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.
12008179|NCT00531804|Drug|gantenerumab|Administered iv at escalating doses (7 cohorts)
12008180|NCT00531791|Drug|prednisone group|Patients in the prednisone group will receive prednisone 40 mg per day with concomitant placebo diskus 2 inhalations twice a day for 10 days. All patients will receive oral antibiotics for 10 days, which will include moxifloxacin (Avelox®) 400 mg die or amoxicillin/clavulanate (Clavulin®) 875mg bid and short-acting bronchodilators (Ventolin®, Bricanyl®, Atrovent®) as needed.
12008181|NCT00531791|Drug|Advair group|Patients in the second group will receive Advair® 50/500 ug 2 inhalations twice daily with placebo pills once a day for 10 days (twice the regular dosage). All patients will receive oral antibiotics for 10 days, which will include moxifloxacin (Avelox®) 400 mg die or amoxicillin/clavulanate (Clavulin®) 875mg bid and short-acting bronchodilators (Ventolin®, Bricanyl®, Atrovent®) as needed.
12008182|NCT00531765|Other|sodium bicarbonate infusion|short infusion of sodium bicarbonate
12008183|NCT00531752|Drug|PF-03654746|Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21
12008184|NCT00531752|Drug|Placebo capsules|Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period.
12008185|NCT00531752|Drug|PF-03654746|Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 1 mg (2 x 0.5 mg capsules) of PF-03654746 given daily for three weeks
12008186|NCT00531739|Other|Polylactic Acid Sheet|SurgiWrapTM film will be secured in two study areas: directly below the abdominal incision and on the posterior pelvic rim. The film will not be wrapped directly around an anastomosis.
12008187|NCT00531726|Device|DBS of Cg25|
12008188|NCT00531713|Drug|Triiodothyronine|50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3
12008189|NCT00531700|Other|Health messaging|Combinations of personalized health messages (tailored/targeted) and contextualized health messages (reports about localized epidemiologic risk) will be delivered to subjects
12008190|NCT00531700|Other|Health messages|community level health messages unrelated to the study originating exposures
12008191|NCT00531687|Drug|Paclitaxel|"Paclitaxel 175 mg/m2 day 1 (3 hour infusion)
~Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered."
12008192|NCT00531687|Drug|Cisplatin|"cisplatin 50 mg/m2 day 1 and 2
~Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered."
12008193|NCT00531687|Drug|Gemcitabine|"gemcitabine 1000mg/m2 days 1 and 8 (in a 30 minute infusion)
~Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered"
12008194|NCT00531674|Dietary Supplement|fortified milk-based beverage|Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
12008195|NCT00531674|Dietary Supplement|Sprinkles|Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
12008196|NCT00531674|Dietary Supplement|tablets|Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
12008197|NCT00531674|Dietary Supplement|Fortified milk-based pap|Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children.
12008198|NCT00531674|Dietary Supplement|Sprinkles|Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
12008199|NCT00531674|Dietary Supplement|Syrup|Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
12008200|NCT00531661|Device|HF Pressure Measurement System|A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
12008201|NCT00531635|Drug|Mycophenolate Mofetil|Induction of Mixed Hemopoietic Chimerism in Patients Using Mycophenolate Mofetil
12008202|NCT00531622|Drug|saredutant (SR48968)|oral administration, capsules
12008203|NCT00531622|Drug|escitalopram|oral administration, capsules
12008204|NCT00531622|Drug|placebo|oral administration, capsules
12008205|NCT00531596|Drug|EMSAM (Selegiline Transdermal System) 6mg/24Hr|EMSAM 6mg/24HR
12008206|NCT00531596|Drug|EMSAM (Selegiline Transdermal System) 9mg/24Hr|EMSAM 9mg/24Hr
12008207|NCT00531596|Drug|EMSAM (Selegiline Transdermal System) 12mg/24hr|EMSAM 12mg/24Hr
12008208|NCT00531583|Drug|Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation|Autologous PBSCT
12008209|NCT00531557|Drug|Darunavir ritonavir|
12008210|NCT00531544|Drug|SU011248|SU011248 Expanded Access Protocol for Systemic Therapy
12008211|NCT00531518|Drug|aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine|Oral, daily, generally at lower than manufacturer's recommendations
12008212|NCT00531518|Behavioral|Psychoeducational multifamily group treatment|Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
12008213|NCT00531518|Behavioral|Supported employment and education|Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
12008214|NCT00531492|Behavioral|TK as soon as possible within 24 hours after birth|Start TK as soon as possible within 24 hours after birth
12008215|NCT00531492|Other|Conventional care|Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
12008216|NCT00531479|Drug|voriconazole|"First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd.
~Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd.
~Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd,
~OR
~Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
~Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy."
12008217|NCT00531479|Drug|anidulafungin|"First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
~Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
~Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
~OR
~Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
~Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy."
12008218|NCT00531479|Drug|voriconazole|"First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
~Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
~Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
~OR
~Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
~Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy."
12008219|NCT00531466|Drug|tolperisone HCl (AV650)|One tablet orally three times a day for 28 days
12008220|NCT00531466|Drug|Placebo|One tablet orally three times a day for 28 days
12008221|NCT00531453|Drug|bortezomib, dexamethasone, and thalidomide|"VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21)
~Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.
~Thalidomide will be given by mouth (p.o.)every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime)."
12008222|NCT00531453|Drug|bortezomib, dexamethasone, thalidomide, and cyclophosphamide|"VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy(HDT)and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21).
~Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.
~Thalidomide will be given by mouth (p.o.) every day, starting on Day 1 of Cycle 1 (e.g., the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).
~Cyclophosphamide will be given as an intravenous (i.v.) dose of 400 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for a total of 4 cycles."
12008223|NCT00531440|Drug|Everolimus (RAD001)|
12008224|NCT00531427|Drug|Buprenorphine|transdermal system 10 and 20 applied for 7-day wear
12008225|NCT00531427|Drug|Placebo|transdermal system (placebo) applied for 7-day wear
12008226|NCT00531401|Drug|Salirasib|600mg BID until disease progression or unacceptable toxicity occurs.
12008227|NCT00531375|Device|Silicone hydrogel contact lens|
12008228|NCT00531362|Drug|Plain aspirin|Plain aspirin 75 mg or 150 mg
12008229|NCT00531349|Procedure|propofol general anesthesia|Regional analgesia combined with sedation or a propofol general anesthesia
12008230|NCT00531349|Drug|Sevoflurane|General anesthesia
12008231|NCT00531336|Drug|intravitreal injection of Bevacizumab (Avastin)|1.25 mg Avastin intravitreally applied once in arm 1 every 6 weeks in arm 2
12008232|NCT00531336|Drug|Pegaptanib (Macugen)|0.3 mg intravitreally applied every 6 weeks as long as required
12008233|NCT00531323|Drug|TMC125 once daily|Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily
12008234|NCT00531323|Drug|TMC125 twice daily|Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily
12008235|NCT00531310|Drug|Reduced Intensity Conditioning, Busulfan and Fludarabine|Busulfan and Fludarabine
12008236|NCT00531297|Procedure|endoscopic posterior mesorectal resection|6 weeks after local excision of a T1 rectal cancer a rectum sparing endoscopic removal of the dorsal part of the mesorectum by EPMR is performed.
12008237|NCT00531284|Drug|Carfilzomib|Administered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion
12008238|NCT00531284|Drug|Dexamethasone|Administered orally or by IV infusion prior to carfilzomib
12008239|NCT00531271|Drug|ABI-008 (nab-docetaxel)|ABI-008; 60-200 mg/m²; Intravenous infusion every 3 weeks.
12008240|NCT00531258|Device|rTMS|Bilateral rTMS
12008241|NCT00531258|Device|Sham rTMS|sham rTMS
12008242|NCT00531245|Drug|TS-1, oxaliplatin|Oxaliplatin(130 mg/m2) day 1, intravenously TS-1 at a dose of 60, 70, 80, 90, 100, 110, 120 mg/m2 given orally starting day 1 until day 14(2 weeks ON, 1 weeks OFF), every 3 weeks
12008243|NCT00531232|Drug|clofarabine|Oral daily x 5 every 28 days. 25 mg/day. Up to 8 cycles
12008244|NCT00531219|Procedure|Transgastric Appendectomy|The appendix will be removed through an incision in the stomach and pulled out through the mouth
12008245|NCT00531219|Procedure|Transgastric Cholecystectomy|The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.
12008246|NCT00531206|Drug|Tipranavir|
12008247|NCT00531206|Drug|Ritonavir|low dose
12008248|NCT00531193|Drug|BIIB014|oral administration of BIIB014, given once daily for 8 to 12 consecutive days, at various doses as specified in protocol
12008249|NCT00531193|Other|[11C]SCH442416|11C]SCH442416 is a radiolabelled tracer molecule that specifically binds to adenosine A2A sites and will be used to evaluate receptor occupancy. The target activity will be 370 MBq. [11C]SCH442416 will be administered IV as a bolus injection over 30 seconds following the start of each PET scan.
12008250|NCT00531180|Procedure|4D CT scans|Three 4D CT scans will be performed. After you are out of the CT scanner, ventilation images will be calculated from the 4D CT images and will be compared with the standard ventilation imaging method.
12008251|NCT00531180|Procedure|Lung Function Imaging|Lung function imaging performed to provide information on how well the lungs work, how air moves into the lungs with breathing, and blood circulation into the lungs.
12008252|NCT00531167|Drug|combination of lamivudine+adefovir vs entecavir|Lamivudine 100 mg/day, Adefovir 10 mg/day, Entecavir 0.5 mg/day
12008253|NCT00531141|Other|examination only|OCT performed twice
12008254|NCT00531128|Behavioral|High/Low Sitosterol|
12008255|NCT00531115|Drug|cetuximab 5mg/ml|"Weekly administration of Cetuximab (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes) Oxaliplatin. 130 mg/m2 every three weeks. on day 1 for 4 cycles Capecitabine. 1000 mg/m2 twice daily (2.000 mg/m2 total daily dose) or 750 mg/m2 if Cl Cr=30-50 ml/min (1500 mg/m2 total daily dose) for two weeks (on days 1 to 14) followed by one week of rest (on days 15 to 21).
~The patients will receive 4 cycles of cetuximab plus combination chemotherapy administered every 3 weeks in order to achieve a noticeable response. Then, oxaliplatin treatment will be stopped after a maximum of 4 infusions to prevent appearance of neuropathy and then followed by capecitabine 2 weeks out of 3, and cetuximab weekly as maintenance treatment."
12008256|NCT00531102|Other|continuous positive airway pressure|Infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes
12008257|NCT00531102|Other|Free flow oxygen|Infants will receive 50% oxygen delivered by a modified neonatal T-piece resuscitator circuit that does not generate pressure for at least 5 minutes.
12008258|NCT00531089|Drug|Rituximab|Rituximab will be administered on weeks 1, 2, 3, and 4 at a dose of 375 mg/m2 per infusion. Premedications (prednisone 50 mg, diphenhydramine 50 mg, acetaminophen) will be administered prior to study infusion. Patients will also be treated with plasma exchange as per institution/apheresis centre.
12008259|NCT00531076|Biological|bevacizumab|"Intravenous bevacizumab at 7.5mg/kg and 15mg/kg concurrently with thoracic radiotherapy in sequential cohorts.
~In the final dose level, bevacizumab 15mg/kg concurrent with radiation will be followed by maintenance bevacizumab 15mg/kg up to a maximum of 6 cycles"
12008260|NCT00531063|Drug|Everolimus (RAD001)|
12008261|NCT00531050|Drug|Indacaterol|Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).
12008262|NCT00531050|Drug|Placebo|Single dose indacaterol matching placebo via Concept 1 device
12008263|NCT00531050|Drug|Salmeterol|Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.
12008264|NCT00531024|Drug|Bevacizumab|3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
12008265|NCT00531024|Drug|Sodium Chloride|3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals
12008266|NCT00531011|Device|XIENCE V® Everolimus Eluting Coronary Stent System|Coronary artery placement of a drug-eluting stent
12008267|NCT00531011|Device|TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System|Coronary artery placement of a drug-eluting stent
12008268|NCT00530998|Procedure|Transvaginal Appendectomy|The appendix will be removed via an incision in the vagina.
12008269|NCT00530998|Procedure|Transvaginal Cholecystectomy|The gallbladder will be removed via an incision in the vagina.
12008270|NCT00530985|Behavioral|Benefits Counseling|Help deciding whether to work
12008271|NCT00530985|Behavioral|VA Orientation|Orientation to services available at VA
12008272|NCT00530972|Drug|Peginterferon alfa-2a plus ribavirin adjusted to body weight|PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg)
12008273|NCT00530946|Drug|Amlodipine 2.5mg/Atorvastatin 5mg|Single pill combination, dosed once daily for 8 weeks
12008274|NCT00530946|Drug|Amlodipine 2.5mg/Atorvastatin 10mg|Single pill combination, dosed once daily for 8 weeks
12008275|NCT00530946|Drug|Amlodipine 5mg/Atorvastatin 5mg|Single pill combination, dosed once daily for 8 weeks
12008276|NCT00530946|Drug|Amlodipine 5mg/Atorvastatin 10mg|Single pill combination, dosed once daily for 8 weeks
12008277|NCT00530933|Procedure|Percutaneous posterior tibial nerve stimulation|Once weekly for 30 minutes
12008278|NCT00530933|Procedure|Transcutaneous tibial nerve stimulation|30 minutes once weekly
12008279|NCT00530933|Procedure|Sham transcutaneous tibial nerve stimulation|Once weekly for 30 minutes
12008280|NCT00530920|Drug|tipranavir|
12008281|NCT00530920|Drug|ritonavir|
12008282|NCT00530907|Drug|Valproic Acid|5.3 mg/kg by mouth daily x 28 days
12008283|NCT00530907|Drug|Bevacizumab|2.5 mg/kg by vein over 90 minutes every 2 weeks
12008284|NCT00530894|Device|Edwards SAPIEN Transcatheter Heart Valve|
12008285|NCT00530894|Device|Surgical Valve Replacement|
12008286|NCT00530894|Other|medical management and/or balloon aortic valvuloplasty|
12008287|NCT00530881|Drug|PHX1149|
12008288|NCT00530868|Other|Letrozole (Femara)|Letrozole 2.5 mg PO a day for 24 weeks
12008289|NCT00530868|Drug|Letrozole; Avastin|Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
12008290|NCT00530855|Drug|Lacosamide|50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
12008291|NCT00530842|Drug|Tiotropium plus Salmeterol|
12008292|NCT00530842|Drug|Fluticasone/Salmeterol|
12008293|NCT00530829|Drug|zinc|10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months
12008294|NCT00530816|Drug|carfilzomib|Intravenous (IV) injection over 2 to 10 minutes twice weekly for three weeks followed by 12 days of rest.
12008295|NCT00530803|Drug|EMLA Cream|60 minutes x1
12008296|NCT00530803|Combination Product|Synera Patch|20 minutes x1
12008297|NCT00530790|Drug|ropinirole controlled release (CR)-RLS|White film-coated round-shaped tablet
12008343|NCT00530387|Drug|19 organic sunscreen filters and 5 topical NSAIDs|
12008298|NCT00530777|Drug|valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
12008299|NCT00530777|Drug|placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
12008300|NCT00530764|Drug|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
12008301|NCT00530764|Drug|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
12008302|NCT00530764|Drug|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
12008303|NCT00530751|Other|counseling intervention|Participants undergo a 45-60 minute interview to assess their attitudes and concerns about providing family medical history online for genetic risk assessment or research. Participants' feelings about whether or not to use an online genetic assessment tool (i.e., Genetic Risk Easy Assessment Tool [GREAT]) are explored.
12008304|NCT00530738|Drug|Lipoplus|i.v. fat emulsion for parenteral nutrition
12008305|NCT00530738|Drug|Lipofundin MCT|i.V. fat emulsion for parenteral nutrition
12008306|NCT00530725|Procedure|chest drainage|may be a chest tube of chest drainage procedure of any type (ie formal tube, pig-tail catheter, etc)
12008307|NCT00530725|Other|close clinical observation|close clinical observation in an operating room or intensive care unit without active intervention
12008308|NCT00530712|Device|PROTÉGÉ® EverFlex™ Self-Expanding Stent System|Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.
12008309|NCT00530699|Drug|AZD1152|intravenous
12008310|NCT00530686|Drug|Islet cell transplantation|The process is based on the enzymatic isolation of the pancreatic islets of Langerhans from an organ procured from a cadaveric donor; the islets obtained are injected into the liver of the recipient via percutaneous catheterization of the portal venous system . This procedure allows the selective transplantation of the insulin-producing cell population avoiding open surgery as well as the transplantation of the duodenum and the exocrine pancreas and their related morbidity.
12008311|NCT00530660|Biological|H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted|All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.
12008312|NCT00530634|Drug|cisplatin|
12008313|NCT00530634|Drug|gemcitabine hydrochloride|
12008314|NCT00530634|Genetic|gene expression analysis|
12008315|NCT00530634|Genetic|reverse transcriptase-polymerase chain reaction|
12008316|NCT00530634|Other|immunohistochemistry staining method|
12008317|NCT00530634|Procedure|adjuvant therapy|
12008318|NCT00530634|Procedure|conventional surgery|
12008319|NCT00530634|Radiation|radiation therapy|
12008320|NCT00530621|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
12008321|NCT00530621|Drug|placebo|oral, daily
12008322|NCT00530621|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
12008323|NCT00530595|Drug|candesartan or valsartan or losartan|
12008324|NCT00530582|Drug|progesterone|300mg progesterone /placebo each for 21 days
12008325|NCT00530569|Procedure|Blood Test|CBC and HER2 level at baseline, prior to each chemo and/or herceptin cycle, one month after chemo and/or herceptin completion, quarterly up to 12 months or a maximum of 20 blood draws.
12008326|NCT00530556|Drug|zolpidem|
12008327|NCT00530543|Procedure|Robot-assisted gait training|
12008328|NCT00530530|Drug|ASP8825|oral
12008329|NCT00530530|Drug|Placebo|oral
12008330|NCT00530517|Device|Intraject Sumatriptan|needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan
12008331|NCT00530504|Device|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device|Carotid artery stenting with distal embolic protection.
12008332|NCT00530491|Procedure|Fast track lung surgery|fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray
12008333|NCT00530478|Drug|Donepezil|
12008334|NCT00530452|Drug|CG100649|Dual-acting COX-2 inhibitor & carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).
12008335|NCT00530452|Drug|Silicified microcrystalline cellulose + talc|Gelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day.
12008336|NCT00530439|Other|Lifestyle intervention|Dietician counselling and physical training
12008337|NCT00530439|Other|Control|Repeated measuring of maternal weight gain, blood samples and ultrasound
12008338|NCT00530439|Behavioral|Physical activity, dietetic counselling|"The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation.
~Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week."
12008339|NCT00530413|Drug|Phenobarbital|Phenobarbital will be given based on weight range
12008340|NCT00530413|Other|Placebo|Placebo group
12008341|NCT00530400|Drug|cefuroxime|preoperative intravenous 1.5g cefuroxime
12008342|NCT00530400|Drug|placebo|preoperative intravenous placebo
12008344|NCT00530374|Dietary Supplement|Oral Iron Supplement|Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
12008345|NCT00530374|Dietary Supplement|Placebo|Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
12008346|NCT00530361|Drug|Nesiritide|
12008347|NCT00530348|Biological|Alemtuzumab|Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
12008348|NCT00530348|Biological|Interferon beta-1a|Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
12008349|NCT00530335|Drug|Atomoxetine|40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
12008350|NCT00530322|Procedure|Laparoscopy|"A second-look laparoscopy, in patients who require further surgery (for example a liver resection or closure of ileostomy)."
12008351|NCT00530309|Drug|GSK716155 for injection|GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.
12008352|NCT00530309|Drug|Placebo|Subjects will also receive placebo.
12008353|NCT00530296|Behavioral|Cognitive Behavioral Therapy|"Group therapy, 12 sessions (90 minutes each, one session per week) manual Coping with depression course"
12008354|NCT00530283|Other|PET-CT|
12008355|NCT00530270|Drug|Dexamethasone|Individuals meeting entry criteria will be randomized to receive dexamethasone 0.3 mg/kg (12 mg maximum single dose). The study drug will be given by mouth every 12 hours until discharge from the hospital or for a maximum of 4 doses (2 days), whichever occurs first. Thereafter, study drug will be tapered over 6 days for a total duration of therapy not to exceed 8 days.
12008356|NCT00530270|Drug|Placebo|Individuals meeting entry criteria will be randomized to receive 0.3 mg/kg (12 mg maximum single dose) of placebo. The study drug will be given by mouth every 12 hours until discharge from the hospital or for a maximum of 4 doses (2 days), whichever occurs first. Thereafter, study drug will be tapered over 6 days for a total duration of therapy not to exceed 8 days.
12008357|NCT00530257|Drug|Placebo|Placebo (sugar pill)
12008358|NCT00530257|Drug|OROS-methylphenidate|18 mg to 54 mg once a day for 1 week
12008359|NCT00530244|Dietary Supplement|Docosahexaenoic acid (DHA)|Infant formula with 0.96% of fatty acids as DHA
12008360|NCT00530244|Dietary Supplement|Standard formula (Enfamil)|This is a standard, commercially available infant formula.
12008361|NCT00530218|Drug|Ganciclovir|Following the first CMV-positive blood culture on day 21 or later, or the first two consecutive CMV-positive PCR tests on day 21 or later, 5mg/kg/bid x 7 days of Ganciclovir is given intravenously, followed by oral Ganciclovir 1000 mg tid 7 days per week x 5 weeks
12008362|NCT00530205|Other|physiologic testing|
12008363|NCT00530205|Other|questionnaire administration|
12008364|NCT00530205|Procedure|management of therapy complications|
12008365|NCT00530205|Radiation|radiation therapy|
12008366|NCT00530192|Other|Treatment based on Molecular Profiling|Treatment with commercially available treatments (per package insert instructions)
12008367|NCT00530179|Procedure|Autologous Blood Stem Transplantation|2 CYCLES OF R-CHOP + R-DICEP/R-BEAM FOLLOWED BY AUTOLOGOUS BLOOD STEM CELL TRANSPLANTATION
12008368|NCT00530179|Drug|R-CHOP|6 - 21 DAY Cycles of R-CHOP
12008369|NCT00530166|Drug|JNJ-18054478|3(100 mg) tablets once daily for 12 weeks
12008370|NCT00530166|Drug|sham comparator|3(100 mg) tablets once daily for 12 weeks
12008371|NCT00530153|Behavioral|dietary counseling|Various activities and materials for teachers, students, parents and school catering personnel aiming at increasing their awareness and knowledge of good nutrition.
12008372|NCT00530153|Dietary Supplement|xylitol|Delivery of xylitol lozenges (about 1 g xylitol/student/school day) and guidance on tooth brushing.
12008373|NCT00530140|Biological|Follicular lymphoma, patient-specific, soluble protein idiotype vaccine|0.5 mg of idiotype conjugated to 0.5 mg of KLH + 125 mcg of GM-CSF 5 monthly vaccinations followed by 3 bi-monthly vaccinations, followed by one boost every three months until either relapse or death from cause unrelated to lymphoma
12008374|NCT00530127|Drug|placebo|Same dose and frequency as treatment
12008375|NCT00530127|Drug|deferiprone|100 mg/mL
12008376|NCT00530127|Drug|deferiprone|100 mg/mL
12008377|NCT00530127|Drug|placebo|Same dosage and frequency as study drug
12008378|NCT00530127|Drug|deferiprone|100 mg/mL
12008379|NCT00530114|Drug|AMG 223|1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
12008380|NCT00530114|Drug|Placebo|1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
12008381|NCT00530101|Drug|Doxorubicin|"This pilot study will select patients who are at increased likelihood to develop cardiotoxicity, due to borderline cardiac function at baseline, advanced age, or the anticipation of a high cumulative dose of administered doxorubicin. Patients who will receive radiation therapy to the left chest during chemotherapy (i.e., left breast cancer) will be excluded so as to eliminate possible cardiotoxic effects from radiation. CMR studies will be performed at no charge to the patient, supported by the sponsor of this study. CMR imaging will be subject to IRB approval, informed consent, and HIPAA regulations. Contrast-enhanced CMR will be obtained at three time points:
~Patients will not undergo contrast-enhanced MR unless calculated GFR is equal to or greater than 60 mL/min/1.73 m2"
12008382|NCT00530088|Drug|porfimer sodium|IV
12008383|NCT00530088|Drug|Photdynamic Therapy (PDT)|
12008384|NCT00530075|Drug|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles
12008385|NCT00530062|Drug|Albuterol-HFA-MDI|Inhalation Aerosols, 90 mcg, 1 dose per treatment period
12008386|NCT00530062|Drug|Albuterol-HFA-BAI|Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
12008387|NCT00530049|Other|questionnaire administration|
12008388|NCT00530049|Procedure|assessment of therapy complications|
12008389|NCT00530049|Procedure|psychosocial assessment and care|
12008390|NCT00530049|Procedure|quality-of-life assessment|
12008391|NCT00530023|Device|MiniMed Paradigm REAL-Time System|MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
12008392|NCT00530010|Radiation|yttrium Y 90 glass microspheres|The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.
12008393|NCT00529997|Device|Stabilimax NZ® Dynamic Spine Stabilization System|Surgical Implantation
12008394|NCT00529984|Biological|AVX701|4 doses of AVX701 at 4e7 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
12008395|NCT00529984|Biological|AVX701|4 doses of AVX701 at 1e8 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
12008396|NCT00529984|Biological|AVX701|4 doses of AVX701 at 4e8 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
12008397|NCT00529984|Biological|AVX701|4 doses of AVX701 given at the maximally tolerated dose at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
12008398|NCT00529984|Biological|AVX701|4 Doses of AVX701 given to Stage III colon cancer subjects at the maximally tolerated dose at T=0, 3, 6, 9 weeks. There will be no option for subjects to receive additional immunizations.
12008399|NCT00529971|Behavioral|MBSR group|8-week MBSR group, 3 hours per week plus one all day retreat
12008400|NCT00529971|Other|Control|Treatment as usual, which could include medications or psychotherapy
12008401|NCT00529958|Procedure|Patellar Tendon|Patellar Tendon autograft
12008402|NCT00529958|Procedure|Hamstring Tendon|Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
12008403|NCT00529958|Procedure|Double-Bundle|Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
12008404|NCT00529945|Device|PFx Closure System|
12008405|NCT00529932|Other|CD133+ infusion|Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
12008406|NCT00529932|Other|placebo infusion|Buffered normal saline will be infused in the coronary artery during an angiography.
12008407|NCT00529919|Dietary Supplement|Weight loss|Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil
12008408|NCT00529880|Drug|Fludarabine , cytarabine|
12008409|NCT00529867|Drug|Artemether/lumefantrine tablets|"Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine
~Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets
~Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2"
12008410|NCT00529867|Drug|Artemether/Lumefantrine suspension|"Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension
~Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml
~Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2"
12008411|NCT00529854|Other|SIC-IR Billing Module|Medical informatic application designed to help with billing and documentation within the surgical and trauma intensive care unit
12008412|NCT00529841|Drug|Hydrocortisone sodium acetate|Subcutaneous administration of medication via insulin pump
12008413|NCT00529828|Procedure|Consumption of CLA enriched food|
12008414|NCT00529815|Device|Continuous Glucose Monitor|The intervention group will alternate the use of the CGM with episodic self blood glucose monitoring for four cycles of two weeks using the CGM and episodic SBGM and one week only using episodic SBGM during the 12 week study.
12008415|NCT00529815|Device|Glucometer|The control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer.
12008416|NCT00529802|Drug|RAD001|take 2 tablets of RAD001 once a day by mouth (10 mg per day)
12008417|NCT00529789|Drug|duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
12008418|NCT00529776|Procedure|Continuous lateral rotation therapy|
12008419|NCT00529763|Drug|Dasatinib|Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study
12008420|NCT00529750|Drug|IRBESARTAN|Tablets
12008421|NCT00529750|Drug|Atenolol|Tablets
12008422|NCT00529737|Procedure|Breast Biopsy|Stereotactic-guided breast biopsy via standard practice of care
12008423|NCT00529737|Procedure|Post Procedure Mammogram|View of post-procedure mammogram same projection as used in the biopsy procedure (View A), and mammographic view orthogonal projection to the first view (View B).
12008424|NCT00529724|Behavioral|Energy metabolism by chronic bilateral subthalamic stimulation|Patients will be studied before and after STN-DBS surgery
12008425|NCT00529711|Drug|Hypertonic lactate|"Solution given parenterally as follows:
~Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours."
12008426|NCT00529711|Drug|Ringer's lactate|"Solution given parenterally as follows:
~Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours."
12008427|NCT00529698|Biological|Biologically active recombinant Tat protein|
12008428|NCT00529672|Procedure|crossectomy and short stripping|under spinal or complete anaesthesia
12008429|NCT00529672|Procedure|ultrasound guided sclerotherapy with foam|1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
12008430|NCT00529672|Procedure|endovenous laser therapy|940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.
12008431|NCT00529659|Drug|Comparator: MK-0773|MK-0773 50 mg tablets twice daily, 6 month treatment period
12008432|NCT00529659|Drug|Comparator: Placebo|Placebo tablets twice daily, 6 month treatment period
12008433|NCT00529646|Drug|APD791|
12008434|NCT00529633|Drug|Thalidomide|Thalidomide by mouth at night for a total of 24 weeks
12008435|NCT00529633|Other|Sugar pill|Placebo by mouth at night for a total of 24 weeks
12008436|NCT00529620|Drug|sulfalene-pyrimethamine plus amodiaquine|Monthly treatments during the malaria transmission season
12008437|NCT00529620|Drug|dihydroartemisinin plus piperaquine|Monthly treatments during the transmission season
12008438|NCT00529620|Drug|sulfadoxine pyrimethamine plus piperaquine|Monthly treatments during the malaria transmission season
12008439|NCT00529607|Drug|contrast echocardiography|directly after PCI, at 24 h after PCI, before discharge and at 6 months
12008440|NCT00529607|Procedure|2D and 3D echocardiography|directly after PCI, at 24 h after PCI, before discharge and at 6 months
12008441|NCT00529607|Procedure|cardiac MRI|before discharge and after 6 months
12008442|NCT00529607|Procedure|blood sampling|"routine lab work plus infarction and inflammation biomarkers
~1: before PCI, after PCI, at 34 hours, at discharge, at 6 months 2 and 3: one blood sample in total before PCI in 2 and at any time in 3"
12008443|NCT00529594|Drug|placebo (Control Group)|Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
12008444|NCT00529594|Drug|Etoricoxib (Treatment Group)|Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
12008445|NCT00529581|Drug|C105|
12008446|NCT00529568|Drug|eltrombopag|double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg
12008447|NCT00529568|Drug|placebo|double-blind matched placebo control daily oral administration
12008448|NCT00529555|Drug|minocycline HCl 2.1%|Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
12008449|NCT00529555|Procedure|Scaling and root planing|scaling and root planing
12008450|NCT00529542|Drug|Lipitor|40mg caplets per day for six weeks
12008451|NCT00529542|Drug|Placebo|1 placebo caplet per day for six weeks.
12008452|NCT00529529|Drug|Indacaterol 300 μg|Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
12008453|NCT00529529|Drug|Salmeterol 50 μg|Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
12008454|NCT00529529|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
12008455|NCT00529529|Drug|Placebo to salmeterol|Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
12008456|NCT00529516|Biological|Fluarix|Single dose, Intramuscular injection
12008457|NCT00529516|Biological|GSK Biologicals Influenza Vaccine GSK576389A|Single dose, Intramuscular injection
12008458|NCT00529503|Drug|SGN-40|2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
12008459|NCT00529503|Drug|placebo|Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
12008460|NCT00529503|Drug|rituximab|375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
12008461|NCT00529503|Drug|etoposide|100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
12008462|NCT00529503|Drug|carboplatin|AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
12008463|NCT00529503|Drug|ifosfamide|5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
12008464|NCT00529490|Drug|Hypertonic lactate|Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
12008465|NCT00529490|Drug|Ringer's lactate|Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG
12008466|NCT00529477|Other|1. Wright Nebulizer|The Wright nebulizer will be used to perform the methacholine challenge.
12008467|NCT00529477|Other|Pari LC Nebulizer|The Pari LC nebulizer will be used to perform the methacholine challenge.
12008468|NCT00529477|Other|The Pari Sinustar Nebulizer|The Pari Sinustar nebulizer will be used to perform the methacholine challenge.
12008469|NCT00529464|Procedure|Fluorescence Spectroscopy|Pictures of the cervix will be taken before and after the application of acetic acid. A clean probe will be placed against the cervix that sends out light and reads how much light is absorbed by the tissue.
12008470|NCT00529464|Procedure|Colposcopy|A standard colposcopy will be performed.
12008471|NCT00529464|Procedure|LEEP Procedure|A small heated wire loop is used to remove a cone-shaped piece of abnormal tissue. Procedure is performed on the same day as the colposcopy exam.
12008472|NCT00529451|Drug|Aliskiren|Aliskiren
12008473|NCT00529451|Drug|Ramipril|comparator
12008474|NCT00529438|Drug|Bardoxolone methyl|
12008475|NCT00529425|Drug|Ropivacaine|
12008476|NCT00529412|Other|Seprafilm|two sheets per body
12008477|NCT00529399|Drug|GAD-Alum|Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
12008478|NCT00529399|Drug|GAD-Alum and Aluminum hydroxide|Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
12008479|NCT00529399|Drug|Aluminum hydroxide|Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
12008480|NCT00529386|Drug|Botox|300 units
12008481|NCT00529373|Drug|Odanacatib|50 mg tablet orally once weekly (OW)
12008482|NCT00529373|Drug|Placebo for Odanacatib|50 mg tablet orally OW
12008483|NCT00529373|Dietary Supplement|Vitamin D3|5600 IU orally OW
12008484|NCT00529373|Dietary Supplement|Calcium carbonate|If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg
12008485|NCT00529360|Drug|Clofarabine|Dose escalation of clofarabine on Days -9, -8, -7, -6, -5: 1 - 30 mg/m2; 2 - 40 mg/m2; 2 - 46 mg/m2; 3 - 52 mg/m2
12008486|NCT00529360|Drug|Clofarabine|Use dose of clofarabine established in Part A to further define event free, disease free and overall survival.
12008487|NCT00529347|Device|neurally adjusted ventilatory assist (NAVA)|assessment of breathing pattern at various ventilator settings
12008570|NCT00528749|Other|Patient will wear ARES device while undergoing sleep study|Device is worn on forehead
12008571|NCT00528723|Drug|salbutamol 100 mcg|To be used as needed for symptom relief
12008488|NCT00529334|Radiation|CyberKnife Partial Breast Irradiation|Body radiosurgery will be delivered to the lumpectomy cavity with specified margin. Radiation dose will be 600 cGy x 5 stages = 3000 cGy over five to ten total days.
12008489|NCT00529321|Biological|MVA-HCV (Immunotherapy)|MVA-HCV
12008490|NCT00529308|Device|Transcranial Magnetic Stimulation (active)|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
12008491|NCT00529308|Device|Transcranial Magnetic Stimulation (sham)|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
12008492|NCT00529295|Drug|misoprostol|Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina
12008493|NCT00529282|Drug|Ceftobiprole Medocaril|500 mg every 8 hours
12008494|NCT00529282|Drug|Cefepime with or without vancomycin|120-minute infusion [250 mL]
12008495|NCT00529269|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12008496|NCT00529256|Behavioral|Feeback group|The intervention practices received a quarterly comparative feedback performance report based on the Achievable Benchmarks of Care (ABC) research conducted by Kieffe (YEAR).
12008497|NCT00529243|Drug|raltegravir|This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.
12008498|NCT00529230|Behavioral|Questionnaire|A set of questionnaires regarding sexual function, physical and psychological symptoms.
12008499|NCT00529230|Other|Blood draws to assess gonadal function|Testosterone, FSH, and LH levels at study onset.
12008500|NCT00529217|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
12008501|NCT00529204|Drug|exenatide|Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24
12008502|NCT00529191|Drug|Atorvastatin|Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months
12008503|NCT00529191|Other|Placebo|One out of three subjects will receive a placebo.
12008504|NCT00529178|Drug|Pravastatin|
12008505|NCT00529165|Procedure|injection-meal-interval|"The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
~Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
~Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval
~Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks."
12008506|NCT00529152|Drug|Deferiprone|Ferriprox (deferiprone) oral solution will be given orally at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided into 3 doses, for 24 weeks.
12008507|NCT00529139|Device|Standard extended dialysis|Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)
12008508|NCT00529139|Device|Intensified extended dialysis|Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L)
12008509|NCT00529126|Drug|SKY0402|SKY0402
12008510|NCT00529126|Drug|Bupivacaine HCl|Bupivacaine HCl
12008511|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (150 mg/day) for 21 days
12008512|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (300 mg/day) for 21 days
12008513|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (150 mg/day) for 28 days
12008514|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (200 mg/day) for 28 days
12008515|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (250 mg/day) for 28 days
12008516|NCT00529113|Drug|Bardoxolone methyl|Bardoxlone methyl capsules (300 mg/day) x 28 days
12008517|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (350 mg/day) x 28 days
12008518|NCT00529113|Drug|Gemcitabine|1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
12008519|NCT00529113|Drug|Placebo|Placebo capsules x 28 days
12008520|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days
12008521|NCT00529100|Drug|Pemetrexed Phase 1|300 mg/m^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m^2 IV; then 500 mg/m^2 IV, repeated every 21 days (q 21 days) x 2 cycles
12008522|NCT00529100|Drug|Cisplatin Phase 1|"Cohorts 1-3: 25 mg/m^2 IV, Days 1-3 and 22-24 then 75 mg/m^2 IV, q21 days x 2 cycles
~Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles."
12008523|NCT00529100|Procedure|Radiation Therapy|Phases 1 and 2: 61-65 Gy in 33-35 fractions
12008524|NCT00529100|Drug|Pemetrexed Phase 2|Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22.
12008525|NCT00529100|Drug|Cisplatin Phase 2|Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.
12008526|NCT00529087|Drug|N-methylnaltrexone bromide (MOA-728)|Subcutaneous
12008527|NCT00529087|Other|placebo|placebo
12008572|NCT00528723|Drug|BDP/salbutamol HFA pMDI|Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo
12008573|NCT00528723|Drug|BDP/salbutamol CFC pMDI|Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo
12008574|NCT00528710|Dietary Supplement|SAM-e (S-Adenosyl-L-Methionine)|One 400 mg tablet daily in the morning.
12008528|NCT00529074|Device|Epidural Catheter for Analgesia|Patients enrolled will be placed into one of two groups of 30 patients. The decision to place the patients in either one of the two groups will be randomized as above. The Epidural group will have a thoracic epidural catheter placed pre-operatively at the T6-T7 level before general anesthesia is given. (using a .1% Marcaine and .1% Meperidine solution) A dose of Ketorolac will be given 15 minutes before the patient will be awakened from anesthesia (provided that there is good renal function and the patient is not hypovolemic) The catheter will be used preoperatively as an adjunct for general anesthesia as well as used postoperatively for continuous epidural analgesia(CEA). The control group will be given general anesthesia alone and post-operative PCA along with NSAIDS before leaving for the recovery room (as above).
12008529|NCT00529048|Other|Oral Glucose Tolerance Test|The test is preformed 3 times with 3 different amounts of glucose (25g, 75g and 125g) deluded in 300ml of water.
12008530|NCT00529048|Other|Isoglycemic clamp|I.v. glucose infusion initiating the glucose responds curves from the OGTT
12008531|NCT00529048|Other|Gastric emptying rate|Paracetamol absorption test. Intake of 1,5g of paracetamol followed by measuring the absorption curve
12008532|NCT00529035|Drug|Interleukin-2|Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.
12008533|NCT00529022|Drug|Azacitidine|75 mg/m^2 Subcutaneous Injection or by vein Daily for 5 Days.
12008534|NCT00529022|Drug|Valproic Acid|40 mg/kg by mouth Daily for 7 days.
12008535|NCT00529022|Drug|Carboplatin|AUC 2 by vein on Days 3 and 10 over 60 Minutes.
12008536|NCT00529009|Drug|UDCA|
12008537|NCT00528996|Drug|BEA 2180 BR|
12008538|NCT00528996|Drug|tiotropium|
12008539|NCT00528983|Drug|Subcutaneous (SC) Azacitidine|75 mg/day for first 7 days of 28 day cycle for 1 cycle only.
12008540|NCT00528983|Drug|Oral Azacitidine|Cycle 2 and beyond starting dose of 120 mg/day for first 7 days of 28 day cycle. Dose will escalate in increments of 60 mg. Following evaluation dose escalation will occur in 120 mg increments until maximum tolerated dose (MTD) is reached.
12008541|NCT00528983|Drug|Oral Azacitidine|Starting dose for 14 day-QD treatment schedule will be 300 mg/day. Starting dose for 14 day-BID, 21 day-QD, 21 day-BID treatment schedules will be 100 mg, 200mg, 300mg. Dose will escalate in increments of 100 mg until MTD is reached.
12008542|NCT00528970|Drug|MOA-728|MOA-728 will be administered per the dose and schedule specified in the arm.
12008543|NCT00528970|Drug|Placebo|Placebo matching to MOA-728 will be administered per the schedule specified in the arm.
12008544|NCT00528957|Drug|Tenofovir DF|Tenofovir DF (oral powder or tablet): 300-mg tablets for participants > 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to > 37 kg may be switched from the oral powder to the tenofovir DF tablet.
12008545|NCT00528957|Drug|Zidovudine|Zidovudine as prescribed by the investigator prior to study entry (pediatric participants < 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).
12008546|NCT00528957|Drug|Stavudine|Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m^2 every 8 hours; pediatric participants > 12 years of age: 300 mg twice daily).
12008547|NCT00528931|Biological|collagenase clostridium histolyticum|Single dose of AA4500 0.58 mg into the cord
12008548|NCT00528918|Drug|Glulisine (Apidra)|An algorithm to determine the initial doses of insulin and dose adjustments is as follows: Lean subjects (BMI less than 25 kg/m2) will initially receive a total of 0.4 units/kg/day, overweight subjects (BMI 25-30 kg/m2) 0.5 units/kg/day and obese subjects (BMI greater than 30 kg/m2) 0.6 units/kg/day. Fifty percent of the total amount of insulin will be given as Glargine and 50% as regular insulin or Apidra. Supplemental short-acting insulin will be given for hyperglycemia before meals. Automated order sets shall be generated to minimize errors in order entries. Glucose concentrations will be measured before each meal and at bedtime, and if symptomatic. In addition, eight-point blood glucose profiles will be obtained every three days starting on day 2. Dose adjustments will be made to keep blood glucose concentrations between 80 and 120 mg/dl pre-prandially and less than180 mg/dl after meals.
12008549|NCT00528905|Drug|AZD3480|oral capsule
12008550|NCT00528892|Drug|Raltegravir|switching PI to raltegravir
12008551|NCT00528892|Drug|boosted PI|continue on boosted-PI
12008552|NCT00528879|Drug|Dapagliflozin|Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
12008553|NCT00528879|Drug|Placebo|Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
12008554|NCT00528879|Drug|Metformin|Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
12008555|NCT00528866|Drug|bicalutamide|50 mg (one tablet) daily orally for 6 months, starting within 6 months after registration
12008556|NCT00528866|Drug|docetaxel|75 mg/m2 IV over 1 hour on day 1 of each cycle q21 days for 6 cycles, starting 3-6 weeks after completion of radiation therapy
12008557|NCT00528866|Drug|flutamide|250 mg (two 125-mg capsules) three times daily (total 750 mg) orally for 6 months, starting within 6 months after registration
12008558|NCT00528866|Drug|LHRH agonist|LHRH agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 6 months, starting within 6 weeks after registration
12008559|NCT00528866|Radiation|3-dimensional conformal radiation therapy|
12008560|NCT00528866|Radiation|radiation therapy|66.6 Gy (1.8 Gy per fraction, 5 days per week) to the prostate bed (IMRT or 3DCRT), starting 8 weeks after start of hormones
12008561|NCT00528840|Biological|collagenase clostridium histolyticum|Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
12008562|NCT00528827|Drug|Cardene® I.V.|"5 mcg/kg/min Cardene I.V.
~2.5 mcg/kg/min Cardene I.V.
~0.5 mcg/kg/min Cardene I.V."
12008563|NCT00528814|Other|Active Hand Sanitizer|Active Hand Sanitizer
12008564|NCT00528801|Behavioral|NP Battery|Neuropsych Battery with 7 different tests that evaluate the patients neurological functioning.
12008565|NCT00528801|Procedure|MRI|The MRI is a standard procedure involving 30 minutes under the machine in order to obtain various images of the patients brain.
12008566|NCT00528788|Drug|doxercalciferol|
12008567|NCT00528775|Drug|HPPH|4 mg/m2 IV
12008568|NCT00528775|Procedure|endoscopic procedure|Treatment with 150 joules from laser
12008569|NCT00528762|Behavioral|Focus Group|Focus group discussion about puberty and body image lasting 1 1/2 hours.
12008575|NCT00528697|Drug|ABT-089|Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
12008576|NCT00528697|Drug|atomoxetine|Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
12008577|NCT00528697|Drug|placebo|Subject will take a tablet once daily for 8 weeks
12008578|NCT00528684|Biological|REOLYSIN®|REOLYSIN® is administered as a single intratumoral infusion over 72 hours. Dose levels in Phase 1 will be 1x10E8, 3x10E8, 1x10E9, 3x10E9, 1x10E10 TCID50. The dose level for Phase 2 will be the top dose reached in Phase 1.
12008579|NCT00528671|Drug|phenprocoumon|The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.8 - 2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients, INR-self management once a week
12008580|NCT00528671|Drug|phenprocoumon|The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management once a week
12008581|NCT00528671|Drug|phenprocoumon|The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management twice a week
12008582|NCT00528658|Drug|Paracetamol|1g qid
12008583|NCT00528658|Drug|Ibuprofen|400mg tid
12008584|NCT00528658|Drug|Paracetamol Placebo|equivalent to 1g qid
12008585|NCT00528658|Drug|Ibuprofen placebo|Equivalent to 400mg tid
12008586|NCT00528645|Drug|saracatinib|Given orally
12008587|NCT00528632|Other|Specimen biopsy and serum laboratory tests|"Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy
~Laboratory tests measuring levels of plasma total cholesterol and triglycerides"
12008588|NCT00528619|Drug|Sunitinib, Pemetrexed, Cisplatin, Carboplatin|Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg*min/mL until progression or unacceptable toxicity.
12008589|NCT00528606|Biological|collagenase clostridium histolyticum|Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
12008590|NCT00528606|Biological|Placebo|Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
12008591|NCT00528593|Drug|epoetin alfa|Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.
12008592|NCT00528580|Drug|Simvastatin|80 mg once daily PO/NG x 4 days
12008593|NCT00528580|Drug|Identical-appearing placebo|once daily x 4 days
12008594|NCT00528567|Drug|Bevacizumab|Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
12008595|NCT00528567|Drug|Standard adjuvant chemotherapy|All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
12008596|NCT00528554|Procedure|laser acupuncture|laser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course
12008597|NCT00528554|Procedure|placebo laser acupuncture|laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
12008598|NCT00528541|Biological|botulinum toxin type A|200 Units at Visit 1 (Day 1)
12008599|NCT00528541|Biological|botulinum toxin type A|750 Units at Visit 1 (Day 1)
12008600|NCT00528528|Drug|Telaprevir|Oval tablets containing 375 mg of telaprevir for oral administration.
12008601|NCT00528528|Drug|Peg-IFN-alfa-2a|Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.
12008602|NCT00528528|Drug|Peg-IFN-alfa-2b|Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.
12008603|NCT00528528|Drug|Ribavirin (RBV) tablet|Tablets containing 200 mg RBV for oral administration.
12008604|NCT00528528|Drug|Ribavirin (RBV) capsule|Capsules containing 200 mg RBV for oral administration.
12008605|NCT00528515|Drug|Diprivan (propofol), Astra-Zeneca|continuous intravenous infusion with a dose of 3-5 mg/kg/h
12008606|NCT00528515|Drug|Suprane (desflurane), Baxter|a vapor concentration of 3-7 vol% is maintained with use of vaporizer and under control of arterial blood pressure, heart rate, and BIS index.
12008607|NCT00528502|Drug|Lidocaine|Lidocaine is misted into the air that you breathe during the surgery.
12008608|NCT00528502|Drug|Saline|Saline is misted into the air that you breathe during the surgery.
12008609|NCT00528489|Biological|PennVax B|DNA vaccine containing the HIV genes Gag, Pol, and Env
12008610|NCT00528489|Biological|IL-12|Cytokine injection
12008611|NCT00528489|Biological|IL-15|Cytokine injection
12008612|NCT00528463|Procedure|sciatic nerve block|Sciatic nerve block, Labatt approach, with a stimuplex needle and catheter. Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op
12008613|NCT00528450|Drug|arsenic trioxide|
12008614|NCT00528450|Drug|idarubicin|
12008615|NCT00528450|Drug|tretinoin|
12008616|NCT00528437|Drug|temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid|13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
12008617|NCT00528424|Biological|AA4500|Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections.
12008618|NCT00528411|Drug|Ticagrelor Tablets|Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD)
12008619|NCT00528411|Drug|Clopidogrel (over encapsulated) capsule|Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD)
12008664|NCT00527995|Drug|Sildenafil|Orally administered, Sildenafil 100mg, unique administration
12008620|NCT00528411|Drug|Aspirin Tablets|Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
12008621|NCT00528398|Drug|cytarabine|
12008622|NCT00528398|Drug|idarubicin|
12008623|NCT00528385|Drug|Spironolactone (Spironol) 25 mg|In the 8-weeks run-in period ACEI, cilazapril (5 mg), telmisartan (80 mg) and hydrochlorotiazyd (12.5 mg) were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 25 mg of spironolactone in two active treatment periods lasting 8 weeks each.
12008624|NCT00528372|Drug|Dapagliflozin|Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
12008625|NCT00528372|Drug|Dapagliflozin placebo|Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks
12008626|NCT00528372|Drug|Metformin|
12008627|NCT00528359|Drug|quetiapine or olanzapine or risperidone or aripiprazole|
12008628|NCT00528346|Behavioral|cognitive training using fMRI|Participants will be scanned using fMRI while they employ the cognitive training strategies-allowing them to view their brain activity.
12008629|NCT00528346|Behavioral|placebo|Some participants will see simulated data that does not come from their own brains.
12008630|NCT00528333|Drug|Lintuzumab (SGN-33)|600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.
12008631|NCT00528333|Drug|Low dose cytarabine|20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.
12008632|NCT00528333|Drug|Placebo|IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles
12008633|NCT00528320|Device|Ovatio CRT|
12008634|NCT00528307|Device|HIS buldle ablation|HIS bundle ablation, followed by implant of a biventricular pacemaker
12008635|NCT00528294|Radiation|GRID radiotherapy|GRID-radiotherapy followed by biological imaging guided IMRT
12008636|NCT00528281|Drug|Lapatinib|Lapatinib was administered once daily orally. Patients will begin treatment at Dose Level 0, using a lower dose of pemetrexed, 400mg (approved dose is 500mg). Absent a DLT or need for treatment delay in cycle 1, Dose level 0 or 1, patients may be dose escalated to dose level 1 or 2, respectively in cycle 2.
12008637|NCT00528281|Drug|Pemetrexed|Pemetrexed is administered intravenously on a 21 day schedule. Two dose levels are used in the dose escalation: 400 and 500 mg.
12008638|NCT00528268|Drug|Sodium phenylbutyrate (NaPB)|The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months.
12008639|NCT00528255|Drug|Misoprostol Vaginal Insert (MVI 100)|The MVI 100 is misoprostol 100 mcg, formulated in a sustained release, nonbiodegradeable hydrogel polymer, with a polyester knit retrieval tape; IV oxytocin is permitted ad lib 30 minutes following removal of the MVI assuming no contraindications.
12008640|NCT00528242|Drug|SLx-2101|
12008641|NCT00528242|Drug|Placebo|
12008642|NCT00528229|Radiation|Computer Tomography|
12008643|NCT00528216|Drug|Capsaicin Dermal Liquid|
12008644|NCT00528190|Drug|Itraconazole|Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
12008645|NCT00528177|Drug|Morphine and oxycodone|"At the end of surgery, group 1 will receive intravenous morphine 0.07 mg/kg and intravenous PCA morphine 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours. Group 2 will receive intravenous oxycodone 0.07 mg/kg and intravenous PCA oxycodone 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours.
~The patients will use the PCA until the next morning."
12008646|NCT00528164|Behavioral|Team PLAY|Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling, including a self-management program to use with their children at home. The group will meet once a week for the initial 8 weeks, bi-weekly for 8 weeks, and monthly for 2 months.
12008647|NCT00528151|Drug|curcumin|curcumin 250 mg twice a day in the first group. placebo 1 capsule twice a day in the second group.
12008648|NCT00528138|Other|Laboratory Test|CRP, white blood cell count, hepatic function tests
12008649|NCT00528125|Procedure|active laser acupuncture|low level laser acupuncture, 830 nm, 30 mW, 0,3 J per acupoint, 2 points per neonate (Hegu and Shen Men). Overall 30 seconds of treatment
12008650|NCT00528125|Procedure|placebo laser acupuncture|placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.
12008651|NCT00528112|Drug|LCS12|Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
12008652|NCT00528112|Drug|LCS16|Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
12008653|NCT00528099|Drug|IMA-026|SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV
12008654|NCT00528073|Drug|Rifaximin-EIR|Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease
12008655|NCT00528060|Drug|Atazanavir|2pills/day
12008656|NCT00528060|Drug|Ritonavir|1 pill/day
12008657|NCT00528060|Drug|Tenofovir/emtricitabine|1 pill/day
12008658|NCT00528047|Drug|PRLX 93936|PRLX 93936 will be administered intravenously over one hour daily for 5 days.
12008659|NCT00528034|Procedure|Lymphoscintigraphy|Procedure where a very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done before the patient has surgery or begins radiation therapy.
12008660|NCT00528021|Drug|Placebo|Vehicle Only
12008661|NCT00528021|Drug|BGC20-0582|BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.
12008662|NCT00528008|Other|povidone-iodine solution|Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.
12008663|NCT00528008|Other|chlorhexidine gluconate|Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.
12009387|NCT00522392|Drug|dexamethasone|Given PO
12008665|NCT00527982|Drug|Celecoxib|600 mg by mouth daily for a total of 12 months.
12008666|NCT00527969|Drug|HT1001 extract of Panax quinquefolius L|
12008667|NCT00527943|Drug|Vorapaxar|oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year
12008668|NCT00527943|Drug|Placebo|oral tablets; matching placebo for vorapaxar; loading and maintenance dosing; once daily for at least 1 year
12008669|NCT00527930|Drug|TS-1 and Eloxatin|"S-1 80 mg/m2/day on day 1-14 Oxaliplatin 130 mg/m2 IV for 2 hour on day 1 Every 3 week
~Number of Cycles: until progression or unacceptable toxicity"
12008670|NCT00527917|Device|placebo|bladder instillation
12008671|NCT00527917|Device|Uracyst|20 ml sterile solution for weekly intravesical instillation
12008672|NCT00527904|Drug|PN400 (VIMOVO)|Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed.
12008673|NCT00527904|Drug|PN 400 (VIMOVO)|500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months
12008674|NCT00527891|Procedure|Signa Excite 3.0 T MRI Scan|Signa Excite 3.0 T MRI scan within a two week period from the date of receiving standard 1.5 T MR of the liver area.
12008675|NCT00527878|Drug|Ranitidine|Double blinded, randomized placebo controlled crossover study. Patients received 12 months of placebo and 12 months of treatment medication (ranitidine).
12008676|NCT00527878|Drug|Placebo|
12008677|NCT00527865|Drug|DAS181|DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
12008678|NCT00527865|Drug|Placebo|Capsules containing 10.5 mg of lactose will be supplied as placebo.
12008679|NCT00527852|Device|Flocked swab|
12008680|NCT00527826|Drug|Salmeterol / Fluticasone (50/500 µg) BID fixed combination|comparator
12008681|NCT00527826|Drug|Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers|comparator
12008682|NCT00527813|Procedure|prone position|prone position for at least 16 hours per day
12008683|NCT00527800|Drug|Dihydroartemisinin-piperaquine|Once daily for 3 days, given in fixed dose tablets (40 mg dihydroartemisinin + 320 mg piperaquine) according to weight-based guidelines
12008684|NCT00527800|Drug|Artemether-lumefantrine|Dosed twice daily for 3 days, given in fixed dose tablets (20 mg artemether + 120 mg lumefantrine) according to weight-based guidelines
12008685|NCT00527800|Drug|Trimethoprim-sulfamethoxazole|Once daily dosing according to weight based guidelines
12008686|NCT00527787|Drug|PN400 (VIMOVO)|PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.
12008687|NCT00527787|Drug|Naproxen|Naproxen (500 mg) dosed twice daily (bid) orally
12008688|NCT00527761|Drug|Cisplatin|20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy.
12008689|NCT00527761|Drug|Docetaxel|Starting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15).
12008690|NCT00527761|Drug|Temodar|150 mg by mouth (PO) on Days 1 - 5.
12008691|NCT00527748|Device|Non-Measuring Ankle Exerciser|Stretching exercise performed 10 times per day, for six (6) weeks.
12008692|NCT00527735|Drug|Ipilimumab|Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
12008693|NCT00527735|Drug|Placebo|Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
12008694|NCT00527735|Drug|Paclitaxel|175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
12008695|NCT00527735|Drug|Carboplatin|Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
12008696|NCT00527722|Device|Bio-Seal Track Plug|The lung plug will be inserted into the left track when the biopsy needle is removed. The smaller sampling needle is removed, and the lung plug is inserted through the larger needle using a delivery tool that has a plunger to push the plug in place. The lung plug remains in the track left when the larger needle is removed.
12008697|NCT00527722|Other|No lung plug|Standard lung biopsy without placement of the plug.
12008698|NCT00527696|Procedure|transvaginal obturator tape|
12008699|NCT00527683|Drug|Vigabatrin|crystalline drug dissolved in orange juice, dosage escalates from 500 mg twice daily to 1.5 g twice daily over a 3 week period. This dose is maintained for 4 weeks and then tapered to zero over the next two weeks
12008700|NCT00527683|Drug|Placebo|orange juice is administered twice daily in containers indistinguishable from the treatment arm.
12008701|NCT00527683|Behavioral|Group therapy|Participants attend group sessions once a week
12008702|NCT00527670|Procedure|Normal Controls|The control group will have small slivers of tissue removed from the skin and abdomen during surgery to compare genomic information.
12008703|NCT00527670|Procedure|Recurrent Hernia|This group will have small slivers of tissue removed from the skin and abdomen during hernia repair surgery to find genetic proof of hernias being inherited.
12008704|NCT00527657|Drug|Lomustine|Starting dose 30 mg/m^2 by mouth daily on Day 1 and 29.
12008705|NCT00527657|Drug|Temozolomide|75 mg/m^2 by mouth daily on Days 1 to 42.
12008706|NCT00527657|Drug|Thalidomide|200 mg/m^2 by mouth daily.
12008707|NCT00527644|Device|5mm spring clip|Microline Pentax 5mm Visu-Loc Clip Applier
12008708|NCT00527631|Radiation|whole abdomen irradiation using IMRT|Whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions
12008709|NCT00527618|Drug|valacyclovir|valacyclovir 1000 mg orally twice daily for 12 weeks.
12008710|NCT00527618|Drug|acyclovir|acyclovir 400 mg orally twice daily for 12 weeks.
12010361|NCT00514865|Drug|ONO-2333Ms|1-2 mg QD for 8 weeks
12008711|NCT00527605|Drug|Dutasteride 0.5mg capsule|Dutasteride 0.5mg once daily orally
12008712|NCT00527605|Drug|Dutasteride matched placebo|Dutasteride matched placebo once daily orally
12008713|NCT00527592|Drug|Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.
12008714|NCT00527592|Drug|Latanoprost ophthalmic solution 0.005% (XALATAN®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.
12008715|NCT00527579|Drug|[F-18]FBR|
12008716|NCT00527566|Biological|Mepolizumab|IV mepolizumab, 750 mg
12008717|NCT00527553|Dietary Supplement|not enriched egg|daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin
12008718|NCT00527553|Dietary Supplement|lutein|daily lutein enriched egg
12008719|NCT00527553|Dietary Supplement|zeaxanthin|daily zeaxanthin enriched egg
12008720|NCT00527553|Dietary Supplement|egg product from enriched eggs|daily egg product from lutein enriched eggs
12008721|NCT00527540|Drug|Pegylated Interferon alpha 2a + Ribavirin|Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day
12008722|NCT00527527|Procedure|flexion distraction|Chiropractic treatment using the flexion distraction apparatus
12008723|NCT00527527|Other|placebo control|Placebo for comparison with flexion distraction treatment
12008724|NCT00527514|Drug|Amlodipine|Tablets
12008725|NCT00527514|Drug|Olmesartan medoxomil plus amlodipine|Tablets
12008726|NCT00527501|Drug|Travoprost/brinzolamide|
12008727|NCT00527488|Drug|Degarelix|Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
12008728|NCT00527488|Drug|Degarelix|One dose of 32 mg administered as a single administration will be evaluated for 42 days.
12008729|NCT00527488|Drug|Degarelix|Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
12008730|NCT00527488|Drug|Degarelix|One dose of 64 mg administered as a single administration will be evaluated for 42 days.
12008731|NCT00527475|Drug|ranibizumab|0.5 mg. given as an intraocular injection
12008732|NCT00527475|Drug|verteporfin|Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.
12008733|NCT00527462|Procedure|Bronchoscopy|bronchoscopy with segmental allergen challenge
12008734|NCT00527462|Other|Exposure to ultrafine carbon black particles|Exposure to ultrafine carbon black particles for 2 hours
12008735|NCT00527449|Drug|Epirubicin, Carboplatin, Docetaxel|75 mg/m² Docetaxel (60 minutes i.v.) and 90 mg/m² Epirubicin (10-15 min i.v.) on day 1, 22, 42. After these 3 cycles 75 mg/m² Docetaxel (60 minutes i.v.) and Carboplatin AUC 5 (30 min i. v.) on day 63, 84, 105.
12008736|NCT00527436|Dietary Supplement|fish oil|Fish oil pills will be taken daily for 12 weeks
12008737|NCT00527436|Dietary Supplement|Placebo|Placebo (corn oil) will be taken daily for 12 weeks
12008738|NCT00527423|Drug|VEGF Trap Eye|Intravitreal injection
12008739|NCT00527410|Drug|RTA 744|Aqueous solution of RTA 744 is packaged in 5 ml vials - 1 mg/ ml. The drug is mixed in D10W and infused over 2 hours on three consecutive days.
12008740|NCT00527397|Drug|CP-464,005|Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.
12008741|NCT00527397|Drug|CP-464,005|Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.
12008742|NCT00527397|Drug|CP-464,005|Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose:adjusted based on the results of self-monitoring of blood glucose before each meal.
12008743|NCT00527371|Device|GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]|Photoselective vaporization of the prostate will be performed using the GreenLight HPS (TM)laser system (American Medical Systems), which is a high-power (120W) potassium titanyl phosphate (KTP) laser which was licensed by Health Canada in April 2007.
12008744|NCT00527371|Procedure|Transurethral resection of the prostate|Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.
12008745|NCT00527358|Behavioral|SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)|"community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices;
~youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, provide education about avoiding violence;
~school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals;
~Youth drop-in center will provide youth with an adult supervised place to hang out, do homework, or participate in sports and job training."
12008746|NCT00527332|Drug|Bupivacain|5 mg/mL, 4 mL intrathecally as a single dos
12008747|NCT00527332|Drug|Morphine|0.4 mg/mL; 0.5 mL intrathecally as a single dosage
12008748|NCT00527332|Drug|Propofol|2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery
12008749|NCT00527332|Drug|Propofol|Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery
12008750|NCT00527332|Drug|Fentanyl|100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.
12008751|NCT00527332|Drug|Rocuronbromid|0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery
12008752|NCT00527332|Drug|Morphine|5 mg is given IV (intravenously) before end of surgery
12008753|NCT00527319|Drug|VT-122 low dose|VT-122 low dose, dose escalated
12008754|NCT00527319|Drug|VT-122 high dose|VT-122 high dose, dose escalated
12008755|NCT00527306|Dietary Supplement|multivitamin|Subject will be asked to take a multivitamin capsule or a placebo (inactive pill) once a day for one year. There will be an equal chance of getting the multivitamin or the placebo.
12010480|NCT00513981|Drug|methotrexate|
12008756|NCT00527293|Procedure|adjuvant therapy|If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.
12008757|NCT00527293|Radiation|3-dimensional conformal radiation therapy|3-dimensional conformal radiotherapy twice daily for 5-10 days.
12008758|NCT00527293|Radiation|brachytherapy|Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
12008759|NCT00527280|Procedure|Feasibility ot face transplantation|Feasibility ot face transplantation
12008760|NCT00527267|Drug|Placebo|30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally
12008761|NCT00527267|Drug|AMG 073|30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily
12008762|NCT00527254|Device|Telemedicine system|Possibility of sending the SMBG values of the patients to a web page via phone mobile sms messages. The HCP had a password access to this web page to check the blood glucose values of the patients and if necessary send to them sms messages with recommendations.
12008763|NCT00527241|Behavioral|Raices nuevas|8 90-minute sessions (once a week) of problem-posing and facilitated discussion on respect, anger, support, trust, negotiating, partnership with your intimate partner.
12008764|NCT00527228|Drug|deflazacort|In the first 12 months, patients will receive no treatment to assess the natural history of the disease. Afterwards, patients will be treated with deflazacort 1mg/kg/day or placebo for the first month on treatment, from the second month on deflazacort or placebo will be administered on an alternate day regimen). Patients will be randomized to six months verum or placebo each, after a 3-months wash-out patients cross over to the alternate treatment for six months. In a 2-years follow-up phase after the double-blind treatment phase, long-term development of the disorder will be documented.
12008765|NCT00527228|Drug|placebo|
12008766|NCT00527215|Drug|darbepoetin alfa|starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL
12008767|NCT00527202|Drug|botulinum toxin A and saline|
12008768|NCT00527189|Behavioral|Balance Exercises|Home based balance exercises based on Otago Exercise programme
12008769|NCT00527150|Drug|Varenicline Tartrate|Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.
12008770|NCT00527150|Drug|Varenicline Tartrate|Planned dose is Varenicline 2.4 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
12008771|NCT00527150|Drug|Varenicline Tartrate|Planned dose is Varenicline 3 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
12008772|NCT00527150|Drug|Varenicline Tartrate|The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
12008773|NCT00527150|Drug|Varenicline Tartrate|The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
12008774|NCT00527137|Drug|darbepoetin alfa|Dose 100U rHuEPO = 0.42 mcg NESP; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
12008775|NCT00527137|Drug|rHuEPO|same as previous rHuEPO dose at randomization; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
12008776|NCT00527124|Drug|cediranib maleate|Given orally
12008777|NCT00527124|Drug|docetaxel|Given IV
12008778|NCT00527124|Drug|prednisone|Given orally
12008779|NCT00527124|Other|laboratory biomarker analysis|Correlative studies
12008780|NCT00527111|Drug|Cetuximab|
12008781|NCT00527111|Drug|5-fluorouracil|
12008782|NCT00527111|Radiation|Pelvic irradiation|
12008783|NCT00527085|Drug|AMG 073|30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
12008784|NCT00527085|Drug|Placebo|30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
12008785|NCT00527072|Biological|infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
12008786|NCT00527059|Drug|Levosimendan in addition to standard therapy|intravenous infusion of levosimendan (10 minutes bolus with 6 mcg/Kg according to physician judgement, followed by 0.1 mcg/Kg/min for 24 hours) in addition to standard therapy
12008787|NCT00527059|Drug|spironolactone, beta-blockers,ecc|
12008788|NCT00527046|Drug|CP-424,391|
12008789|NCT00527033|Drug|YM178|Oral
12008790|NCT00527033|Drug|Placebo|Oral
12008791|NCT00527020|Drug|GSK1018921|GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.
12008792|NCT00527020|Drug|Nicotine Lozenges|Nicotine Lozenges will be supplied as 4 milligrams lozenges.
12008793|NCT00527020|Drug|Placebo|Placebo tablets will be given to the subjects.
12008794|NCT00527007|Other|External cooling|External cooling
12008795|NCT00526994|Other|screened|Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
12008796|NCT00526994|Behavioral|universal education|receives referral information
12008797|NCT00526981|Other|Prone position|Prone position during spontaneous breathing.
12008798|NCT00526968|Drug|EVT 101|8 mg capsule, single oral dose
12008799|NCT00526968|Drug|EVT 101|15 mg capsule, single oral dose
12008800|NCT00526968|Drug|placebo|Placebo capsule, single oral dose
12008801|NCT00526942|Behavioral|SAAGE-designed, visual memory-based cognitive training|Training sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions.
12008843|NCT00526500|Behavioral|Tilt Table With Integrated Stepping System|Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
12009216|NCT00523809|Drug|Bevacizumab|10 mg/kg IV Daily Over 30 Minutes for 1 Day
12008802|NCT00526929|Drug|darbepoetin alfa|10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week
12008803|NCT00526916|Drug|[C-11]PBR28|
12008804|NCT00526903|Behavioral|Elimination Diet|Daily diet change for 8 days.
12008805|NCT00526890|Dietary Supplement|selenomethionine|Oral Twice daily
12008806|NCT00526890|Drug|carboplatin|Weekly IV
12008807|NCT00526890|Drug|paclitaxel|Weekly IV
12008808|NCT00526890|Other|laboratory biomarker analysis|Correlative Study
12008809|NCT00526890|Radiation|radiation therapy|Undergoing radiation Therapy
12008810|NCT00526877|Drug|Risperidone|Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.
12008811|NCT00526851|Other|survey administration|Nursing home dentists practicing in Ohio are contacted through a recruitment letter and are asked to respond to questions regarding oral cancer screening practices, knowledge of oral cancer detection, and opinions about oral cancer screening using a newly developed survey, which is based on parts of an existing, pre-tested instrument (Oral Cancer Prevention and Early Detection Survey).
12008812|NCT00526838|Drug|XL228|1-hour IV infusion
12008813|NCT00526812|Drug|RTA 744|Aqueous solution added to 10%D/W and infused over 2 hours on three consecutive days. 5 mg vials contain 1 mg/ml.
12008814|NCT00526812|Drug|RTA 744 injection|Aqueous solution in 1mg/ml. Doses are escalated. Drug is infused intravenously over 2 hours one day a week for four consecutive weeks.
12008815|NCT00526799|Drug|Sorafenib|"Phase I: Dose Escalation, Phase II: MTD
~Dose level -1: 200mg po daily Dose level 1: 400mg po daily (MTD) Dose level 2: 400mg po bid"
12008816|NCT00526799|Drug|Topotecan|3.5mg/m2 weekly, 3 weeks on and one week off.
12008817|NCT00526786|Device|CryoSpray Ablation System (510(k) NO: K070893)|no drug interventions specified
12008818|NCT00526773|Other|telephone management plus a motivational intervention|heart failure intervention
12008819|NCT00526773|Other|telephone management with standard patient education|heart failure intervention
12008820|NCT00526760|Drug|Dexmedetomidine|
12008821|NCT00526734|Biological|filgrastim|
12008822|NCT00526734|Biological|pegfilgrastim|
12008823|NCT00526734|Drug|melphalan|
12008824|NCT00526734|Procedure|autologous hematopoietic stem cell transplantation|
12008825|NCT00526695|Drug|Sevoflurane (Preconditioning)|Inhalation of sub-anesthetic doses of sevoflurane
12008826|NCT00526682|Dietary Supplement|Irvingia/cissus combo|
12008827|NCT00526669|Drug|Lapatinib and Capecitabine|oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine
12008828|NCT00526656|Drug|sunitinib malate|50mg PO daily 4 weeks on -2 weeks off
12008829|NCT00526643|Drug|gemcitabine|1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles
12008830|NCT00526643|Drug|cisplatin|cisplatin 60 mg/m2 on day 1 for 4 cycles
12008831|NCT00526630|Drug|Methylphenidate (MPD)|Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day.
12008832|NCT00526630|Drug|Placebo|Participants will be given placebo instead of active MPD.
12008833|NCT00526617|Drug|ABT-888|Oral capsules
12008834|NCT00526617|Drug|Temozolomide|Oral capsules
12008835|NCT00526604|Behavioral|work related rehabilitation|"The workplace intervention includes two steps:
~Evaluations of the work site: The occupational ergonomists task is to identify conditions at the work site, as for instance ergonomic, work demand and relations to the employer and colleagues.
~Therapeutic Return to work: The occupational ergonomists will organize contacts and meetings between the employer and the patients and make a schedule for return to work. The therapeutic return-to-work-process will take place at the work place, with progressively more days at work and progressively increasing tasks."
12008836|NCT00526591|Drug|Everolimus|Patients will receive arm-specific dosage of Everolimus daily continuously for 8 week
12008837|NCT00526591|Procedure|conventional surgery|Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
12008838|NCT00526578|Behavioral|Questionnaire|Questionnaire taking about 30-40 minutes to complete.
12008839|NCT00526565|Behavioral|Tapas Acupressure Technique|Practice of the TAT technique involves application of pressure to select acupoints combined with specific mental focus. The TAT pose involves lightly touching the tips of the left thumb and 4th finger to the area 1/8 inch above the inner corner of each eye and the 3rd finger to the point midway between the eyes, about ½ inch above eyebrow level. The right hand is on the back of the head, with the palm cradling the occiput and the thumb just above the hairline. Once in this position, the process is to 1) focus attention on the identified problem or behavior to be changed (e.g., over-eating); 2) focus on a positive thought related to the problem; 3) focus on the thought of healing or clearing the origins of the problem; and 4) focus on an awareness of healing or clearing any storage of the problem, at a cellular, mental, emotional, or energetic level.
12008840|NCT00526565|Behavioral|Social support|The LIFE SS maintenance intervention will consist of a series of professionally facilitated social support groups where the session content is directed by the participants. The contact hours for SS will match those of the TAT intervention. The initial SS group session will orient participants to the basics of weight maintenance, and subsequent sessions will provide opportunities for participants to share experiences and ask questions. Participants may choose to use behavioral tools as desired. In addition to the basic materials about weight loss maintenance used in both maintenance interventions, will we use the materials already used in the weight loss program for the SS group as needed. We will measure adherence by taking attendance at the SS group sessions.
12008841|NCT00526539|Other|Total hip replacement, Spectron and Taperloc|
12008842|NCT00526513|Drug|Insulin Glulisine|subcutaneous injection of insulin glulisine at meal, 1 to 3 injections a day based on the condition of the patient in addition to a basal SC insulin injection at bedtime
12008844|NCT00526487|Device|Zenith® Dissection Endovascular System|The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
12008845|NCT00526487|Device|Endovascular Repair|Endovascular Repair
12008846|NCT00526474|Drug|Vorapaxar|2.5-mg tablet daily for at least 1 year
12008847|NCT00526474|Drug|Placebo|matching tablet daily for at least 1 year
12008848|NCT00526461|Drug|HPPH|IV
12008849|NCT00526448|Drug|ribavirin|2000 mg/day
12008850|NCT00526448|Drug|ribavirin|1000-1200 mg/day
12008851|NCT00526448|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 180 mcg/week
12008852|NCT00526448|Drug|epoetin beta|epoetin beta 450 UI/week
12008853|NCT00526435|Behavioral|Walk with Ease - Group|Participate in 6-week, 1 hour per week group assisted classes (with instructor).
12008854|NCT00526435|Behavioral|Walk with Ease - Self|SUbject will receive the WWE workbook and follow it without group/instructor assistance.
12008855|NCT00526422|Procedure|Dental Preventive|
12008856|NCT00526409|Drug|Prednisolone|Induction: 60 mg/m2/day, oral or i.v x 21 days and 30 mg/m2/day oral or iv x 7 days Reinduction-Intensification Treatment: 60 mg/m2/d x 14 days and 30 mg/m2/day oral x 7 days
12008857|NCT00526409|Drug|Daunorubicin|Induction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1
12008858|NCT00526409|Drug|Vincristine|Induction: 1,5 mg/m2 iv, days 1, 8, 15, 22 Consolidation (Bloc I):1,5 mg/m2 iv, days 1, 8 Consolidation (Bloc II):1,5 mg/m2 iv, days 1, 8 Reinduction: 1,5 mg/m2 iv, days 1, 8 Maintenance:1,5 mg/m2 iv, day 22
12008859|NCT00526409|Drug|L-Asparaginase|Induction: 10.000 U/m2 im or iv, days 9,11,13,16,18,20,23,25,27 Consolidation (Bloc II): 20.000 U/m2 im or iv, day 7 Maintenance: 20.000 U/m2 im or iv, day 22
12008860|NCT00526409|Drug|Cyclophosphamide|Induction: 500 mg/m2 iv, days 1, 2, 29 Consolidation (Bloc I): 500 mg/m2 iv, day 8 Reinduction:500 mg/m2 iv, day 15
12008861|NCT00526409|Drug|Methotrexate|Consolidation (Bloc I): 5 g/m2 24 hours infusion Consolidation (Bloc II): 5 g/m2 24 hours infusion Reinduction: 3 g/m2 24 hours infusion Maintenance: 20 mg/m2/d, IM/week x 3 (1, 7, 14)
12008862|NCT00526409|Drug|Cytosine Arabinoside|Consolidation (Bloc I): 1 g/m2/12 h iv, days 5, 6 Consolidation (Bloc II): 1 g/m2/12 h iv, days 5, 6 Reinduction: 1 g/m2/12 h iv, days 43, 44
12008863|NCT00526396|Drug|cisplatin|80 mg/m2 on day 1 for 6 cycles
12008864|NCT00526396|Drug|etoposide|100 mg/m2 on days 1,2,3 for 6 cycles
12008865|NCT00526396|Drug|cisplatin|cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
12008866|NCT00526396|Drug|etoposide|etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle
12008867|NCT00526383|Drug|Tricyclic antidepressants|antidepressant version medical dispositive
12008868|NCT00526357|Drug|omega-3 fatty acid|Pharmaceutical grade fish oil administered daily in the form of 10 capsules (5 capsules b.i.d.) each containing 400mg of eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA) which will equate to a daily dose of 4000 mg of EPA and 2000 mg or DHA. The matched placebo containing a 50/50 mix of soybean and corn oil will be supplied by the same manufacturer (Ocean Nutrition, Canada)
12008869|NCT00526331|Device|Vigileo Monitor|Study Group = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Control Group = Information from the monitor will be collected and compared to the information collected from participants in Study Group.
12008870|NCT00526331|Device|FloTrac Sensor|Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.
12008871|NCT00526318|Biological|filgrastim|
12008872|NCT00526318|Drug|carboplatin|
12008873|NCT00526318|Drug|cisplatin|
12008874|NCT00526318|Drug|cyclophosphamide|
12008875|NCT00526318|Drug|dacarbazine|
12008876|NCT00526318|Drug|doxorubicin hydrochloride|
12008877|NCT00526318|Drug|etoposide phosphate|
12008878|NCT00526318|Drug|ifosfamide|
12008879|NCT00526318|Drug|isotretinoin|
12008880|NCT00526318|Drug|melphalan|
12008881|NCT00526318|Drug|topotecan hydrochloride|
12008882|NCT00526318|Drug|vincristine sulfate|
12008883|NCT00526318|Drug|vindesine|
12008884|NCT00526318|Procedure|autologous hematopoietic stem cell transplantation|
12008885|NCT00526318|Radiation|iobenguane I 131|
12008886|NCT00526318|Radiation|radiation therapy|
12008887|NCT00526305|Drug|Vincristine|1,5 mg/m2 i.v., days 1 and 8
12008888|NCT00526305|Drug|Daunorubicin|60 mg/m2, i.v., days 1 and 8
12008889|NCT00526305|Drug|Prednisone|60 mg/m2 day, i.v. or oral, days 1 to 14
12008890|NCT00526305|Drug|L-Asparaginase|10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
12008891|NCT00526305|Drug|Mitoxantrone|12 mg/m2 i.v days 15, 16 and 17
12008892|NCT00526305|Drug|Cytosine Arabinoside|1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
12008893|NCT00526305|Drug|Hydrocortisone|10 mg ,15 mg or 20 mg depending of age
12008894|NCT00526305|Drug|Mercaptopurine|50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
12008895|NCT00526305|Drug|Cyclophosphamide|600 mg/m2 day, i.v., days 1 to 15 in consolidation
12008896|NCT00526305|Drug|Dexamethasone|10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21
12008897|NCT00526292|Biological|natural killer cell therapy|The patient must be admitted by Day -8 to the Bone Marrow Transplant Service. On Day 0, patients will receive a single dose of allogeneic NK cells isolated from a HLA-haploidentical related donor and will be monitored for hematopoietic recovery.
12008898|NCT00526292|Drug|cyclophosphamide|Day -6 cyclophosphamide 60mg/kg infused over 1 hour (dose adjusted for body weight) for 2 days
12008899|NCT00526292|Drug|fludarabine|Day -5 fludarabine 25mg/m2 CIV for 5 days
12008993|NCT00525694|Other|Diet Coke|10 ounces of Diet Coke
12008994|NCT00525694|Other|Coke Zero|10 ounces of Coke Zero
12008900|NCT00526266|Behavioral|Emotional Freedom Techniques (EFT)|A half hour treatment with EFT following a standardized protocol. Both Range of Motion (ROM) physical issues are treated with EFT, as well as any possible emotional issues underlying limited ROM.
12008901|NCT00526266|Behavioral|Diaphragmatic Breathing (DB)|"Diaphragmatic Breathing (DB) instead of EFT tapping, but with all the Setup Statements and components of the Experimental Group, with the exception of tapping. DB is substituted for tapping."
12008902|NCT00526253|Biological|MyoCell|Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.
12008903|NCT00526253|Biological|MyoCell|Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 million cells.
12008904|NCT00526253|Procedure|Hypothermosol|After the cell culture period of time has passed, patient's myocardium will be injected with the transport media alone. Patient will not receive any cultured myoblasts during these injections.
12008905|NCT00526227|Device|Secura ICD|Secura Implantable Cardioverter Defibrillator (ICD) will be implanted
12008906|NCT00526214|Drug|celecoxib medication|In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
12008907|NCT00526201|Behavioral|12-weeks EnhanceFitness|EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.
12008908|NCT00526201|Behavioral|Control|Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).
12008909|NCT00526188|Drug|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
12008910|NCT00526175|Drug|Prednisone|60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35
12008911|NCT00526175|Drug|Vincristine|1,5 mg/m2 i.v., days 8, 15, 22 and 28
12008912|NCT00526175|Drug|Daunorubicin|30 mg/m2, i.v., days 8 and 15
12008913|NCT00526175|Drug|L-Asparaginase|10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.
12008914|NCT00526175|Drug|Cyclophosphamide|1000 mg/m2, i.v., day 22.
12008915|NCT00526175|Drug|Methotrexate|Age <1 year 1-2 years 2-3 years > 3 years MTX 5 mg 8 mg 10 mg 12 mg
12008916|NCT00526175|Drug|Cytosine Arabinoside|Edad <1 year 1-2 years 2-3 years > 3 years ARA-C 16 mg 16 mg 20 mg 30 mg
12008917|NCT00526175|Drug|Mercaptopurine|50 mg/m2,oral, days 1 to 7, 28-35 and 56-63
12008918|NCT00526175|Drug|VP-16|150 mg/m2 i.v., days 14-15 and 42-43
12008919|NCT00526162|Device|Bi-ventricular Implantable Cardioverter Defibrillator|Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
12008920|NCT00526149|Drug|BI 2536|
12008921|NCT00526149|Other|high performance liquid chromatography|
12008922|NCT00526149|Other|mass spectrometry|
12008923|NCT00526149|Other|pharmacological study|
12008924|NCT00526136|Drug|Placebo|
12008925|NCT00526136|Drug|Vernakalant (oral)|Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
12008926|NCT00526123|Device|Symmetric Tip Catheter|Dialysis catheter
12008927|NCT00526123|Device|Conventional Split-tip Catheter|Dialysis Catheter
12008928|NCT00526110|Drug|5-Fluorouracil|2.2 Gm/m^2 IV over 48 hours on Day 1.
12008929|NCT00526110|Drug|Docetaxel|20 mg/m^2 IV over 60 minutes
12008930|NCT00526110|Drug|Oxaliplatin|85 mg/m^2 IV over 120 minutes on Day 1.
12008931|NCT00526097|Drug|Bisacodyl 10 mg|2 x 5 mg bisacodyl once daily
12008932|NCT00526097|Drug|Placebo|Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily
12008933|NCT00526071|Drug|migalastat HCl|
12008934|NCT00526058|Device|Secura then Futura|Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.
12008935|NCT00526058|Device|Futura then Secura|Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.
12008936|NCT00526045|Drug|AUY922 2 mg/m2|
12008937|NCT00526032|Procedure|OIR Imaging|Images from 4 different positions will be taken per lesion. The entire imaging procedure will take about 5 minutes per lesion.
12008938|NCT00526006|Drug|esomeprazole|40 mg od for 8 wks
12008939|NCT00525993|Drug|etoricoxib 90mg 14 days|each patient in this group will receive 90mg once daily, for the 14 days treatment.
12008940|NCT00525993|Drug|etoricoxib 60mg daily for 14 days|Patients in this group will receive 60mg of the drug, daily
12008941|NCT00525980|Behavioral|Computer Program|"Participants will be given a program to learn about breast cancer risk and genetic testing.
~Arm 3 Only = Participants will use the program with the assistance of a promotora (female promoter, community health worker, sometimes known as a lay health advisor)."
12008942|NCT00525980|Behavioral|Focus Group|Focus group discussion lasting about 60 to 90 minutes.
12008943|NCT00525980|Other|Written Materials|Printed materials will be given. The CD-ROM will be offered at the end of the study.
12008944|NCT00525980|Behavioral|Questionnaires|Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
12008945|NCT00525967|Drug|Methadone plus Acetaminophen or Placebo|Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid
12008946|NCT00525954|Drug|A-002|
12008947|NCT00525941|Drug|NBI-34060|10 mg capsules; dosed as needed for falling back asleep after a bothersome awakening provided there are at least 4 hours remaining in bed; no more than one dose per night.
12008948|NCT00525928|Drug|varenicline|varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization
12008949|NCT00525915|Drug|5-Fluorouracil|"Arm A = 250 mg/m^2 IV over 24 hours for 5 days weekly for 5 weeks.
~Arm B = 2.2 mg/m^2 IV over 48 hours on days 1 and 15."
12008950|NCT00525915|Drug|Oxaliplatin|"Arm A: 40 mg/m^2 IV daily over 2 hours for 5 weeks
~Arm B: 100 mg/m^2 IV on Day 1 and 15"
12008951|NCT00525915|Radiation|Radiation Therapy|Radiation treatment every weekday for 5 weeks.
12009094|NCT00524797|Dietary Supplement|Profonycia|
12010481|NCT00513981|Other|mass spectrometry|
12008952|NCT00525915|Procedure|Surgery|Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.
12008953|NCT00525902|Drug|Adalimumab|40 mg delivered every 2 weeks by subcutaneous injection
12008954|NCT00525889|Drug|IL-2|Administered by subcutaneous injection at a dose of 4.5x10^6 IU/day, three times weekly for 28 days starting on day 0.
12008955|NCT00525889|Drug|Rapamycin|Administered orally, initial daily dose of 2mg. At day 7, dose adjusted to achieve and maintain whole blood trough levels of 5-10 ng/ml.
12008956|NCT00525876|Drug|Cyclophosphamide|"Matched Donors:
~750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine.
~Unrelated or Mismatched Donors:
~1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)"
12008957|NCT00525876|Drug|Fludarabine|"30 mg/m^2 given intravenously on Days -5 and -3 before transplantation.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)"
12008958|NCT00525876|Drug|Rituximab|"Matched Donors:
~375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
~Unrelated/Mismatched Donors:
~375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
~For development of disease progression or no response, immunomanipulation with Rituximab 375 mg/m^2 given intravenously, then 1000 mg/m^2 given intravenously weekly for 3 weeks, and taper off Tacrolimus dose over 2 weeks.
~DLI = Donor Lymphocyte Infusion/Immunomodulation Post Transplantation Immunomodulation for patients with lymphoid Malignancies:
~375 mg/m^2 then 1000 mg/m^2 weekly x 3 if immunomanipulation is undertaken for persistent disease."
12008959|NCT00525876|Drug|Alemtuzumab|"Unrelated/Mismatched Donors:
~15 mg per day given intravenously days 1 through 3 after transplantation.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)"
12008960|NCT00525876|Procedure|Allogeneic Stem Cell Infusion|Infusion of stem cells.
12008961|NCT00525863|Drug|oxygen|Patients will be treated with oxygen for 1 month and then for 1 month with regular air with the same flow rate and procedure or randomly in the opposite order. We propose to enrich the inspired oxygen partial pressure from 21 kPA to ~40 kPa in a double blind cross-over design. Ninety percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours/day, throughout the night.
12008962|NCT00525850|Other|high fat diet|high saturated fat no starch diet
12008963|NCT00525850|Other|low saturated fat diet|low calorie low saturated fat low trans fat high fiber diet
12008964|NCT00525837|Drug|fixed dose varenicline|varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.
12008965|NCT00525837|Drug|varenicline|up to 1 mg twice daily
12008966|NCT00525824|Drug|Rosuvastatin (Crestor)|10mg and 20 mg
12008967|NCT00525824|Drug|Ezetimibe|10 mg
12008968|NCT00525824|Drug|Simvastatin|40mg and 80 mg
12008969|NCT00525811|Other|patient dialogue|Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression
12008970|NCT00525811|Other|patient information|Information on acute low back pain, information on depression
12008971|NCT00525798|Drug|SMC021 Oral calcitonin|0.8mg SMC021 - oral calcitonin, once daily
12008972|NCT00525798|Drug|SMC021 Placebo|SMC021 - Placebo, once daily
12008973|NCT00525785|Drug|5-Fluorouracil|"2.2 Gm/m^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43.
~Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump."
12008974|NCT00525785|Drug|Folinic Acid|200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.
12008975|NCT00525785|Drug|Oxaliplatin|"100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43.
~Chemoradiotherapy: 45 mg/m^2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week)."
12008976|NCT00525785|Radiation|Radiotherapy|45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.
12008977|NCT00525785|Procedure|Surgery|4-6 weeks after completion of chemoradiotherapy, restaged & surgical resection of the primary tumor and lymph nodes attempted.
12008978|NCT00525772|Drug|ciclesonide|low dose- 50ug and 200ug
12008979|NCT00525772|Drug|ciclesonide|high dose- 100ug and 400ug
12008980|NCT00525759|Drug|5-FU, Epirubicin, Cyclophosphamide, Docetaxel|3 cycles of FEC q3w, followed by 3 cycles of docetaxel q3w FEC: 5FU 500mg/m2 intravenous bolus D1, Epirubicin 100mg/m2 intravenous bolus D1, Cyclophosphamide 500mg/m2 intravenous bolus D1) every 21 days Docetaxel: (100mg/ m2 intravenous infusion) every 21 days
12008981|NCT00525759|Drug|5-FU, Epirubicin, Cyclophosphamide, Docetaxel, Zoledronic acid|3 cycles of FEC q3w, followed by 3 cycles of docetaxel q3w FEC: 5FU 500mg/m2 intravenous bolus D1, Epirubicin 100mg/m2 intravenous bolus D1, Cyclophosphamide 500mg/m2 intravenous bolus D1) every 21 days Docetaxel: (100mg/ m2 intravenous infusion) every 21 days Zoledronic acid: 4mg intravenous infusion Day 2, AFTER FIRST CYCLE CHEMOTHERAPY ONLY
12008982|NCT00525746|Behavioral|Interview|Interview lasting about 50 minutes.
12008983|NCT00525733|Drug|darunavir 800 mg|darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
12008984|NCT00525733|Drug|FTC 200 mg/TDF 300mg|Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
12008985|NCT00525733|Drug|Maraviroc|Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)
12008986|NCT00525733|Drug|Raltegravir|Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)
12008987|NCT00525733|Drug|Ritonavir 100 mg|one tablet of ritonavir is taken with darunavir daily
12008988|NCT00525720|Drug|Brachytherapy|Brachytherapy implant procedure lasting 1-2 hours.
12008989|NCT00525720|Behavioral|Questionnaire|Questionnaires taking 30 total minutes.
12008990|NCT00525707|Drug|tezosentan|tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
12008991|NCT00525694|Other|Glucose tolerance test|10 ounces glucose tolerance test solution
12008992|NCT00525694|Other|glucose tolerance test solution|75 grams glucose load
12008995|NCT00525681|Drug|cyclosporine A|Cyclosporine is dosed twice daily and is individualized as per center practice and kept stable during the study.
12008996|NCT00525681|Drug|tacrolimus|Dosing of tacrolimus is given twice daily and individualized as per center practice.
12008997|NCT00525668|Drug|epigallocatechin-gallate (Sunphenon)|200 mg twice daily, after 3 months 400 mg twice daily
12008998|NCT00525668|Drug|placebo|2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
12008999|NCT00525655|Behavioral|Web-Based Multimedia Intervention|Website designed to offer information and support for adolescents and young adults with FAP, viewed for 30-60 minutes.
12009000|NCT00525655|Behavioral|Questionnaire|Questionnaires taking 10-15 minutes to complete.
12009001|NCT00525642|Drug|Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide|Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
12009002|NCT00525642|Drug|Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide|Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
12009003|NCT00525629|Dietary Supplement|Walnuts|48 Grams of Walnuts Daily
12009004|NCT00525629|Dietary Supplement|Control|Control Diet with No Walnuts
12009005|NCT00525616|Drug|Mabthera|Two IV perfusions of 1000mg at 15 days intervals
12009006|NCT00525603|Drug|Cyclophosphamide|200 mg/m^2/day 3-5 IV 5-30 minutes
12009007|NCT00525603|Drug|Fludarabine|20 mg/m^2/day 3-5 IV 5-30 minutes
12009008|NCT00525603|Drug|Alemtuzumab|30 mg Days 1, 3, 5 IV 2-4 hours
12009009|NCT00525603|Drug|Rituximab|375 mg/m^2/day 2 IV 4-6 hours
12009010|NCT00525590|Drug|GLIADEL|Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces.
12009011|NCT00525577|Drug|Placebo|Placebo tablet, once daily
12009012|NCT00525577|Drug|AGI-1067|75 mg AGI-1067 tablet, once daily
12009013|NCT00525577|Drug|AGI-1067|150 mg AGI-1067 Tablet, once daily
12009014|NCT00525564|Drug|Placebo|Placebo diskus inhalation powder
12009015|NCT00525564|Drug|Salmeterol diskus inhalation powder|50 micrograms twice a day
12009016|NCT00525551|Drug|Acetylcysteine|150 mg / kg body weight. Drug is dissolved in NaCl to a final volume of 300 mL. This volume is infused starting one hour prior to surgery, and continued 1 hour after the end of surgery.
12009017|NCT00525551|Drug|Placebo (NaCl)|300 mL 0.9% NaCl
12009018|NCT00525538|Radiation|conformal radiotherapy|
12009019|NCT00525525|Drug|Bevacizumab|Patients are given 10 mg/kg IV Q2 weeks.
12009020|NCT00525525|Drug|Tarceva|Patients receive 150 mg PO daily. If patients are not experiencing intolerable toxicity, they may escalate their dose to 200 mg PO daily. If patients are experiencing intolerable toxicity, their dose will be held until the toxicity improves or resolves, then re-treated at a lower dose level, i.e. 100 mg PO daily.
12009021|NCT00525525|Drug|Temozolomide|Patients receive 200 mg/m2 for Days 1-5 of every 28 day cycle. Although the calendar days may be slightly altered, the patient should always receive this dose for 5 days within a treatment cycle. If the patient experiences certain toxicities specified in the protocol, Temodar will be held then given at a reduced dose, i.e. 150 mg/m2 Days 1-5.
12009022|NCT00525512|Drug|tiotropium 18 mcg|Oral inhalation once daily of 18mcg tiotropium via handihaler
12009023|NCT00525512|Drug|Placebo|Oral inhalation of once-daily placebo matching tiotropium via handihaler
12009024|NCT00525499|Drug|ASC-J9 cream|Topical application to the face twice daily for 12 weeks.
12009025|NCT00525499|Drug|placebo|vehicle control applied topically twice daily for 12 weeks
12009026|NCT00525486|Drug|Nifedipine extended release|Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation
12009027|NCT00525473|Drug|Azathioprine|azathioprine usual dosage 100mg per day
12009028|NCT00525460|Behavioral|Fertility-Sparing Survey|A questionnaire completed either in the clinic or at home
12009029|NCT00525447|Drug|SGN-40|2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.
12009030|NCT00525447|Drug|lenalidomide|Up to 25 mg daily of a 21-day cycle.
12009031|NCT00525447|Drug|dexamethasone|40 mg administered weekly.
12009032|NCT00525434|Device|Seraffix LTB|wounds closure by using laser and albumin
12009033|NCT00525421|Drug|Curcuminoids|Curcuminoids tablets 2000mg three times per day for 12 days
12009034|NCT00525421|Drug|Placebo|
12009035|NCT00525408|Biological|Mycobacterium w.|Immunomodulator
12009036|NCT00525408|Drug|Docetaxel|Chemotherapeutic agent
12009037|NCT00525395|Genetic|Sequential phototherapy|Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
12009038|NCT00525395|Procedure|Continuous phototherapy|Group B: 6 months non-stop treatment.
12009039|NCT00525382|Drug|levocetirizine dihydrochloride|
12009040|NCT00525356|Device|Medtronic Talent Stent-Graft-System|
12009041|NCT00525330|Drug|KRP-104 QD Drug: Placebo Drug: Metformin|KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal
12009042|NCT00525330|Drug|Placebo Drug: Metformin|Two tablets 15 to 30 minutes before each meal, morning and evening.
12009043|NCT00525330|Drug|KRP-104 BID Drug: Placebo Drug: Metformin|KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening.
12009044|NCT00525317|Drug|"Nycoplus Magnesium (120 mg x 3 daily for 2 weeks)"|120 mg x 3 or placebo
12009045|NCT00525304|Behavioral|Self-management program for chronic illness|Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
12009150|NCT00524303|Drug|FEC75|5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles
12009217|NCT00523809|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Stem Cell Transplantation on Day 8.
12009046|NCT00525291|Device|Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation|In the 3T arm, patients were stimulated with a carrier wave of 25 KHz and biphasic modulations of the pulse train of 40 Hz. Anxious patients trained at first only in the biofeedback mode. The stimulation was introduced after four weeks for these patients. Patients were instructed to carry out the training at home, with an alternating combination in the morning and with EMG-triggered stimulation in the evening, each for 20-minute periods. Apart from this, the protocol of the active treatment group was identical to that of the control group.
12009047|NCT00525291|Device|EMG-biofeedback alone|In the biofeedback arm, patients were instructed to carry out EMG-biofeedback training at home, standing, mornings and evenings, for 20-minute periods. The core of the task was to pull the plug-electrode upward inside the anal channel, like a lift, and to hold it there during varying periods of tension. This can only be done successfully if the perineum rises and at the same time the puborectal muscle is activated. Just squeezing the sphincter muscles does not produce this lifting effect.
12009048|NCT00525278|Drug|Levocetirizine dihydrochloride|
12009049|NCT00525265|Drug|OPC-41061(Tolvaptan)|Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
12009050|NCT00525265|Drug|Placebo|Subjects will be orally administered placebo once daily after breakfast for seven days.
12009051|NCT00525252|Drug|Baclofen|Baclofen orally administered for 12 consecutive weeks. For the first 3 days, baclofen administered at a dose of 5 milligrams 3 times per day; subsequently, the daily dose of baclofen will be increased to 10 milligrams 3 times per day.
12009052|NCT00525252|Drug|placebo|Placebo will be orally administered for 12 consecutive weeks
12009053|NCT00525239|Drug|ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz|100 mg, twice daily, for four weeks
12009054|NCT00525213|Drug|Rob 803|two capsules per day during 12 weeks
12009055|NCT00525213|Drug|Placebo|two capsules per day during 12 weeks
12009056|NCT00525200|Drug|5-Fluoruracil, Cisplatinum|"5 FU 1000mg/m2; days 1-5; 3 cycles: q21
~Cisplatin 80mg/m2; day 1; 3 cycles: q21"
12009057|NCT00525200|Drug|Docetaxel|Docetaxel 75mg/m2, day 1; 3 cycles; q21
12009058|NCT00525174|Device|Bangerter filters|Bangerter filter worn on sound eye spectacle lens full time
12009059|NCT00525174|Device|Patching|2 hours daily patching of the sound eye
12009060|NCT00525174|Procedure|Near activities|one hour near visual activities
12009061|NCT00525161|Drug|sorafenib|400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
12009062|NCT00525148|Drug|BIBW 2992|This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs
12009063|NCT00525135|Drug|Valproic Acid|"OUTLINE: This is a pilot study.
~Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.
~Quality of life is assessed at the end of every week through a study diary.
~Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months."
12009064|NCT00525109|Other|No Intervention|No intervention
12009065|NCT00525096|Drug|placebo|2 tablets twice a day per os
12009066|NCT00525096|Drug|Celecoxib|2*200 mg tablets twice a day per os
12009067|NCT00525096|Drug|Exemestane|Exemestane 25 mg per day per os
12009068|NCT00525057|Drug|Dalteparin|Given SC
12009069|NCT00525044|Drug|Ambroxol|
12009070|NCT00525044|Drug|Placebo|
12009071|NCT00525031|Drug|Temozolomide (TMZ)|150 mg/m^2 by mouth once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
12009072|NCT00525031|Drug|Pegylated Interferon Alpha-2b (PGI)|0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
12009073|NCT00525018|Device|contact heat evoked potential stimulator|
12009074|NCT00525005|Drug|DOS (Docetaxel, Oxaliplatin and S-1)|Docetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)
12009075|NCT00524966|Procedure|Bipolar Versus Ultrasonic Hemostasis Techniques|OUTLINE: Patients undergoing thyroidectomy for thyroid cancer, thyroid nodules, hyperthyroidism and goiter will be randomized to either bipolar energy sealing system or ultrasonic coagulation.
12009076|NCT00524953|Device|EUMATRON - EN 600 NT|frequency - once a week, starting 4 days after transplantation for four weeks (total of 4 treatments) each treatment will last ~20 minutes. In addition - standard GVHD preventive protocol will be given to patients (including cyclosporine and steroids - if necessary)
12009077|NCT00524940|Biological|Inactivated, Split-Virion Influenza Virus|0.5 mL, Intramuscular
12009078|NCT00524927|Drug|Methoxyflurane|
12009079|NCT00524927|Drug|Normal Saline|
12009080|NCT00524914|Drug|apomorphine|Acute apomorphine subcutaneous 3 mg
12009081|NCT00524914|Drug|placebo|placebo subcutaneous
12009082|NCT00524901|Drug|Epoetin alpha|A single dose of epoetin alpha during CABG for three vessel disease, 60.000 IU intravenously.
12009083|NCT00524901|Drug|NaCl 0.9%|A single dose of NaCl 0.9% during CABG for three vessel disease, 1 ml intravenously.
12009084|NCT00524888|Procedure|suturing laceration|suturing simple lacerations of the hand
12009085|NCT00524888|Procedure|bioadhesive|using bioadhesive on simple lacerations of the hand
12009086|NCT00524875|Drug|Bevacizumab|One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy
12009087|NCT00524862|Drug|Optimized medical therapy|Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
12009088|NCT00524862|Device|Implantable Cardioverter Defibrillator|an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly
12009089|NCT00524849|Biological|Zoledronic acid|Zometa 1 mg weekly (intravenous)
12009090|NCT00524849|Drug|Zoledronic acid|Zometa 4 mg every four weeks (intravenous)
12009091|NCT00524836|Drug|levocetirizine dihydrochloride|
12009092|NCT00524810|Drug|Pegylated liposomal doxorubicin|Caelyx 30 mg/m² day 1 every 3 weeks
12009093|NCT00524810|Drug|Docetaxel|Taxotere 75 mg/m² day 2 every 3 weeks
12009095|NCT00524784|Biological|ApoCell|Three subjects per cohort will be treated with ApoCell according to an escalating schedule of doses starting at a single dose of 35 million apoptotic cells/kg in the first cohort of three subjects. Unless a DLT is experienced by subjects in a given cohort, the dose in the subsequent cohort will be increased by two-fold. The second cohort will receive 70 millions cells/kg, and the third cohort 140 millions cells/kg. The final fourth cohort will receive 210 millions cells/kg.
12009096|NCT00524758|Device|ologen (oculusgen) collagen matrix|Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
12009097|NCT00524758|Drug|MMC in Trabeculectomy|MMC in Trabeculectomy
12009098|NCT00524745|Biological|Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine|Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.
12009099|NCT00524732|Biological|Tetanus and diphtheria toxoids and acellular pertussis|0.5 mL, Intramuscular
12009100|NCT00524719|Procedure|Open Reduction and Internal Fixation|Fixation with volar locked plate
12009101|NCT00524719|Procedure|Non-Spanning External Fixation|Radio-radial external fixation
12009102|NCT00524719|Procedure|Closed Reduction with Percutaneous Fixation|Percutaneous intrafocal pinning (Kapandji technique)
12009103|NCT00524706|Drug|S-1, oral Leucovorin, Oxaliplatin|
12009104|NCT00524693|Drug|Montelukast|4mg sachets
12009105|NCT00524693|Drug|Placebo granules|
12009106|NCT00524680|Dietary Supplement|cholecalciferol|Given orally
12009107|NCT00524667|Drug|Valproic acid & fludarabine|valproic acid (VPA) starting dose of 15 mg/day p.o. in divided doses, increased weekly by 5 mg/kg/day until >1mM Fludarabine 40 mg/m2/day orally will be added after completing 28 days of VPA if participant has been identified as having stable or progressive disease.
12009108|NCT00524654|Procedure|HVLA chiropractic manipulation|
12009109|NCT00524615|Drug|spironolactone|25 mg of spironolactone once daily or placebo for 2 months
12009110|NCT00524602|Procedure|Catheter ablation using the Stereotaxis equipment|Energy delivery through ablation catheter during an interventional catheterisation of the heart.
12009111|NCT00524589|Dietary Supplement|calcitriol|IV
12009112|NCT00524589|Drug|dexamethasone|Oral
12009113|NCT00524589|Genetic|protein expression analysis|Correlative Study
12009114|NCT00524589|Other|laboratory biomarker analysis|Correlative Study
12009115|NCT00524576|Biological|Engerix™-B|One dose (10µg Hepatitis B surface antigen (HBsAg))
12009116|NCT00524550|Dietary Supplement|moderate alcohol consumption|drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks
12009117|NCT00524524|Drug|ARQ 501|Weekly IV Infusion; 450 mg/m2
12009118|NCT00524511|Device|Surgical skin staples|Standard method to close abdominal surgical wounds
12009119|NCT00524511|Device|Dermabond|Alternative method (superglue) to close abdominal surgical wounds
12009120|NCT00524498|Drug|OPC-18|OPC-18: 500IU * 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
12009121|NCT00524498|Drug|cisplatin|infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day
12009122|NCT00524485|Drug|aminolevulinic acid|
12009123|NCT00524485|Procedure|laser therapy|
12009124|NCT00524472|Other|Hyperinsulinemic-normoglycemic clamp|Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
12009125|NCT00524472|Other|insulin at the standard of care levels|Subjects will be administered insulin at the standard of care levels established by the participating institution.
12009126|NCT00524459|Drug|docetaxel|
12009127|NCT00524459|Drug|pegylated liposomal doxorubicin hydrochloride|
12009128|NCT00524459|Procedure|conventional surgery|
12009129|NCT00524459|Procedure|neoadjuvant therapy|
12009130|NCT00524446|Dietary Supplement|Milk-containing fortified spread|Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.
12009131|NCT00524446|Dietary Supplement|Soy-containing fortified spread|Counseling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.
12009132|NCT00524446|Dietary Supplement|Maize-soy flour|Counseling + Vitamin A as for ST_DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.
12009133|NCT00524433|Drug|tezosentan|tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4 mL/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
12009134|NCT00524433|Drug|placebo|
12009135|NCT00524420|Device|rTMS|10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
12009136|NCT00524420|Device|Sham rTMS|10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
12009137|NCT00524407|Drug|Epoetin alfa|
12009138|NCT00524381|Drug|Etanercept (Enbrel)|TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.
12009139|NCT00524381|Drug|Sodium chloride (placebo)|NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.
12009140|NCT00524368|Drug|Darunavir (DRV)|DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.
12009141|NCT00524368|Drug|Ritonavir (rtv)|DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.
12009142|NCT00524342|Drug|Oprelvekin, Interleukin 11, IL-11|25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
12009143|NCT00524316|Drug|doxorubicin hydrochloride|Transarterial chemoembolization
12009144|NCT00524316|Drug|sunitinib malate|Given Orally
12009145|NCT00524316|Other|laboratory biomarker analysis|Correlative Study
12009146|NCT00524316|Procedure|hepatic artery embolization|Surgical procedure
12009147|NCT00524316|Procedure|quality-of-life assessment|Correlative Study
12009148|NCT00524303|Drug|Trastuzumab|4mg/kg IV loading dose followed by 2mg/kg IV weekly
12009149|NCT00524303|Drug|Paclitaxel|80mg/m2 IV weekly for 4 (21 day) cycles
12009151|NCT00524303|Drug|Lapatinib|1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3
12009152|NCT00524277|Biological|GP2 peptide + GM-CSF vaccine|Given intradermally every 3-4 weeks for a total of up to 6 inoculations
12009153|NCT00524277|Biological|GM-CSF (sargramostim)|GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations
12009154|NCT00524277|Biological|AE37 + GM-CSF vaccine|Given intradermally every 3-4 weeks for a total of up to 6 inoculations
12009155|NCT00524277|Biological|GM-CSF (sargramostim)|Given intradermally every 3-4 weeks for a total of up to 6 inoculations
12009156|NCT00524264|Drug|ketorolac|"Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.
~Placebo"
12009157|NCT00524251|Drug|esomeprazole|
12009158|NCT00524238|Drug|L-thyroxine|The hypothyroid patients receive usual treatment with L-thyroxine in our out patient clinic. The doctors there subscribe the medication, this study has no protocol regarding this, we observe the patients again after having been biochemically euthyroid for at least two months.
12009159|NCT00524225|Drug|Neumega (Oprelvekin, Interleukin 11, IL-11)|25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
12009160|NCT00524199|Drug|Mesna|12 mg/kg IV infusion over five minutes at the beginning of dialysis thrice weekly.
12009161|NCT00524199|Other|Saline|Saline IV infusion over five minutes at the beginning of dialysis thrice weekly.
12009162|NCT00524186|Drug|fluorouracil|Given IV
12009163|NCT00524186|Drug|irinotecan hydrochloride|Given IV
12009164|NCT00524186|Drug|leucovorin calcium|Given IV
12009165|NCT00524186|Drug|sunitinib malate|Taken Orally
12009166|NCT00524186|Other|flow cytometry|Correlative Study
12009167|NCT00524186|Other|pharmacological study|Correlative Study
12009168|NCT00524173|Drug|Tenofovir & Emtricitabine|
12009169|NCT00524173|Drug|Tenofovir|
12009170|NCT00524160|Drug|Fentanyl transdermal patch|
12009171|NCT00524147|Procedure|Pigtail drainage|
12009172|NCT00524134|Drug|Carvedilol-CR|Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication.
12009173|NCT00524121|Drug|erlotinib hydrochloride|Oral
12009174|NCT00524121|Other|immunohistochemistry staining method|Correlative Study
12009175|NCT00524121|Radiation|radiation therapy|Radiation Treatment
12009176|NCT00524095|Drug|azithromycin and fluticasone|azithromycin 500 mg once a day three times a week for 6 months and then inhaled steroids (fluticasone 500 ug bid) for 6 months
12009177|NCT00524095|Drug|fluticasone and azithromycin|inhaled steroids (fluticasone 500 ug bid) for 6 months and then azithromycin 500 mg once a day three times a week for 6 months
12009178|NCT00524069|Biological|bevacizumab|
12009179|NCT00524069|Drug|capecitabine|
12009180|NCT00524069|Drug|gemcitabine hydrochloride|
12009181|NCT00524069|Other|flow cytometry|
12009182|NCT00524069|Other|laboratory biomarker analysis|
12009183|NCT00524069|Procedure|adjuvant therapy|
12009184|NCT00524069|Procedure|computed tomography|
12009185|NCT00524069|Procedure|neoadjuvant therapy|
12009186|NCT00524056|Drug|Carisbamate|two 100 mg tablets twice per day
12009187|NCT00524056|Drug|Placebo|two placebo tablets twice per day
12009188|NCT00524043|Drug|Paliperidone ER|1.5 mg tablet once daily for 6 weeks
12009189|NCT00524043|Drug|Placebo|Once daily for 6 weeks
12009190|NCT00524043|Drug|Paliperidone ER|6 mg tablet once daily for 6 weeks
12009191|NCT00524030|Drug|pregabalin 600 mg/day|pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
12009192|NCT00524030|Drug|pregabalin 150 mg/day|pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
12009193|NCT00524017|Biological|cetuximab|given IV
12009194|NCT00524004|Biological|Anti-CsbD Bovine IgG|Three times a day for seven days
12009195|NCT00524004|Other|Placebo|Three times a day for seven days
12009196|NCT00524004|Biological|Anti-CS17 Bovin IgG|Three times a day for seven days
12009197|NCT00523991|Drug|tiotropium|Oral inhalation once daily of 18mcg tiotropium via handihaler
12009198|NCT00523991|Drug|Placebo|Oral inhalation once daily of placebo matching tiotropium via handihaler
12009199|NCT00523978|Device|Arctic Front® Cryoablation Catheter|Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.
12009200|NCT00523978|Drug|Flecainide or Sotalol or Propafenone|Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
12009201|NCT00523965|Drug|amphotericin B deoxycholate|Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions
12009202|NCT00523965|Drug|Liposomal Amphotericin B with Miltefosine|Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or > 25 kg Miltefosine 50 mg once daily if patient weighs <25 mg
12009203|NCT00523965|Drug|Liposomal Amphotericin B and Paromomycin Sulfate|AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11
12009204|NCT00523965|Drug|miltefosine + Paromomycin sulfate|oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days
12009205|NCT00523952|Drug|tacrolimus ointment|tacrolimus, single arm, 0.1 ointment
12009206|NCT00523939|Drug|cytarabine liposome injection|50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
12009207|NCT00523926|Drug|TMC207|
12009208|NCT00523913|Drug|rosiglitazone|
12009209|NCT00523900|Dietary Supplement|Quaker Complete Nutrition Supplements|3-6 250ml cans of Quaker Complete Nutrition Supplements per day
12009210|NCT00523887|Drug|Fentanyl transdermal therapeutic system|
12009211|NCT00523861|Dietary Supplement|Moderate alcohol consumption|
12009212|NCT00523848|Drug|bortezomib|IV
12009213|NCT00523848|Drug|pegylated liposomal doxorubicin hydrochloride|IV
12009214|NCT00523848|Drug|thalidomide|Oral
12009215|NCT00523822|Other|Spinal Manipulative Therapy|
12009218|NCT00523809|Drug|Fludarabine|25 mg/m^2 IV Daily Over 30 Minutes for 5 Days
12009219|NCT00523809|Drug|Melphalan|70 mg/m^2 IV Daily Over 30 Minutes for 2 Days
12009220|NCT00523809|Drug|Thymoglobulin|0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1.
12009221|NCT00523770|Procedure|Urine sample collection|Urine samples will be collected and tested for the presence of S. pneumoniae
12009222|NCT00523757|Drug|Spironolactone|
12009223|NCT00523757|Drug|Placebo|
12009224|NCT00523744|Drug|Amlodipine|Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.
12009225|NCT00523744|Drug|Olmesartan medoxomil|Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.
12009226|NCT00523744|Drug|Amlodipine+valsartan|Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.
12009227|NCT00523744|Drug|Hydrochlorothiazide|Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.
12009228|NCT00523731|Procedure|Angiogenic Cell Precursors (ACPs) or Vescell TM|
12009229|NCT00523718|Drug|riluzole|50 mg PO bid, 12 weeks
12009230|NCT00523718|Drug|placebo|placebo, 1 capsule PO bid, 12 weeks
12009231|NCT00523705|Drug|escitalopram|10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
12009232|NCT00523705|Other|placebo|Placebo tablets matched to drug
12009233|NCT00523692|Drug|Etanercept, methotrexate and depomedrone|Etanercept (50mg weekly; subcutaneous) Methotrexate (7.5-25mg weekly; oral) Depomedrone (up to 120mg; intraarticular / intramuscular)
12009234|NCT00523692|Drug|depemedrone|depomedrone (up to 120mg im/ia) methotrexate (added after symptoms have been present for 12 weeks)
12009235|NCT00523666|Drug|Galantamine (Reminyl®)|8mg - 24mg
12009236|NCT00523666|Drug|Placebo/Galantamine (Reminyl®)|"Patients are treated double-blind with placebo for 6 months, followed by treatment with Galantamine (Reminyl®) for another 6 months.
~Dose scheme: 8mg-24mg"
12009237|NCT00523653|Other|blood test|looking at DNA
12009238|NCT00523640|Drug|combination of gemcitabine, capecitabine, and bevacizumab|gemcitabine 1000 mg/m^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle
12009239|NCT00523588|Procedure|laser treatment (Candela Vbeam Perfecta™)|This laser has an adjustable pulse duration (0.45-40 ms), fixed wavelength 595 nm, spot size (3 mm, 5 mm, 7 mm, and 10 mm), and incident fluence range of 10-40 J/cm2. The laser is also equipped with a dynamic cooling device (DCD) (FDA cleared under K001589) that delivers cryogen (R-134a) from a small nozzle positioned 4 cm above the skin at an angle of approximately 70 degrees with respect to the skin surface. All patients will be treated with the laser device on which the varying cooling device parameters will be selected based on the clinical judgment of the treating physician. Factors used in this decision include patient age, skin type and epidermal pigmentation, size and depth of vessels, color of lesions, anatomic location, etc. In all instances, a test-dose in an inconspicuous location on the skin will be conducted prior to the first treatment.
12009240|NCT00523575|Dietary Supplement|Cubitan|400 ml/d
12009241|NCT00523562|Other|diet intervention|controlled hypercaloric high fructose, high fat, or high fat/high protein diet
12009242|NCT00523549|Drug|valsartan|160 mg or 320 mg tablets once a day
12009243|NCT00523549|Drug|amlodipine|5 mg or 10 mg tablets once a day
12009244|NCT00523536|Behavioral|Patient Navigator - Nurse Team Intervention|The patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors will use information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study will test the effect of this intervention on blood pressure control and utilization of hospital services in adult patients with hypertension.
12009245|NCT00523523|Behavioral|Constraint-Induced Movement Therapy + auditory rhythm cues|The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. Participants in the experimental group will perform this practice to the beat of a metronome. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.
12009246|NCT00523523|Behavioral|Constraint-Induced Movement Therapy|The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.
12009247|NCT00523510|Procedure|Infant feeding counseling that includes Flash-heat|Intensive infant feeding counseling which includes description and demonstration of the WHO recommended option for HIV-infected mothers to pasteurize their breastmilk. Flash-heat pasteurization will be described and demonstrated to interested mothers. More intensive counseling and support will be provided home visits.
12009248|NCT00523497|Device|Non invasive mechanical ventilation|
12009249|NCT00523471|Procedure|Blood test|
12009250|NCT00523458|Drug|efavirenz or nevirapine|"Patients co-infected with HIV and TB will receive either standard doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or high doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin."
12009251|NCT00523445|Drug|Varenicline(Chantix)|The dose of antipsychotic drug will remain fixed throughout the study and the titration of varenicline will be as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice per day for days 4 to 7, then 1 mg twice per day through week 8.
12009252|NCT00523445|Drug|Placebo|The dose of antipsychotic and concomitant medications remained fixed throughout the study and the titration of varenicline was as follows: Placebo will be supplied twice daily through week 8.
12009253|NCT00523432|Drug|Topotecan|Weekly doses via IV infusion. Dose will be assigned based on time of study entry.
12009254|NCT00523432|Drug|CCI-779 (temsirolimus)|Weekly 25mg dose via IV infusion.
12009255|NCT00523419|Drug|Pemetrexed|500 mg/m^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.
12009335|NCT00522795|Drug|PPX with cisplatin and radiation|weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks
12009256|NCT00523406|Procedure|Photodynamic therapy and intravitreal triamcinolone|combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD
12009257|NCT00523393|Drug|Insulin Glargin|Titration of bedtime insulin glargin aiming at normal morning fasting glucose
12009258|NCT00523393|Drug|Human Insulin|Titration of bedtime human insulin aiming at normal morning fasting glucose
12009259|NCT00523380|Drug|recombinant interleukin-21|Administered i.v. in treatment cycles of 28 days.
12009260|NCT00523380|Drug|caelyx (pegylated liposomal doxorubicin)|Administered i.v. in treatment cycles of 28 days.
12009261|NCT00523367|Procedure|24 hour pH testing|24 hour pH testing will be used to screen patients
12009262|NCT00523354|Drug|Infliximab|Induction therapy with 2 infusions, each 5 mg/kg body weight within 2 wks
12009263|NCT00523341|Biological|Denosumab|Administered by subcutaneous injection once every 6 months.
12009264|NCT00523328|Drug|BG9924|dosage administered as per Biogen-idec protocol
12009265|NCT00523302|Device|Active TMS|Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.
12009266|NCT00523302|Device|Sham TMS|Sham TMS uses the same stimulation frequency as the Active TMS but uses the Sham TMS coil instead to prevent actual stimulation from occurring (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.
12009267|NCT00523289|Drug|Bupivacaine|Dosage: 150mg at once for anesthesia induction
12009268|NCT00523289|Drug|Ropivacaine|Single dose of ropivacaine, 150mg
12009269|NCT00523263|Device|heparin-bonded and collagen coated polyster|femoro-popliteal bypass
12009270|NCT00523263|Device|Human umbilical vein femoro-popliteal bypass|
12009271|NCT00523250|Drug|AR-102 0.003% Ophthalmic Solution|
12009272|NCT00523250|Drug|AR-102 0.005% Ophthalmic Solution|
12009273|NCT00523250|Drug|AR-102 0.01% Ophthalmic Solution|
12009274|NCT00523250|Drug|AR-102 0.03% Ophthalmic Solution|
12009275|NCT00523250|Drug|AR-102 Vehicle Ophthalmic Solution|
12009276|NCT00523237|Drug|Raltegravir|400 mg Twice daily for 24 weeks
12009277|NCT00523224|Procedure|Angiogenic Cell Precursors(ACPs) or Vescell TM|at least 1.5 million of ACPs per one time of treatment
12009278|NCT00523224|Biological|Angiogenic Cell Precusors|Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
12009279|NCT00523211|Drug|Vicriviroc|One tablet of vicriviroc 30 mg once daily.
12009280|NCT00523211|Drug|Placebo|One tablet of placebo once daily.
12009281|NCT00523185|Drug|Lorazepam|Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
12009282|NCT00523185|Drug|Diazepam|Diazepam 20 mg by mouth every two hours x 3 doses, or for parenteral treatment, diazepam 10 mg intravenously every one hour x 6 doses. Give additional diazepam 10 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
12009283|NCT00523172|Procedure|manual or manipulative therapy|Active comparator will receive 9 treatments of manual or manipulative therapy to the hip (HVLA hip manipulations per protocol 1) with pre-manipulative static and post manipulative active-assisted stretch of hip muscles after each manipulation.
12009284|NCT00523172|Procedure|Manual / Manipulative Therapy|Active comparator will receive 9 treatments of manual or manipulative therapy to the lumbosacral, sacroiliac, hip and knee, ankle and foot joints (HVLA and Grades I-IV mobilization per protocol 2) stretching and exercise.)
12009285|NCT00523172|Procedure|Supportive Care|"Supportive Care 3) Groups A and B will receive supportive care after the 9th visit consisting of (up to a maximum of) 6 visits, PRN or as needed, until the 9 month follow up. This is to see if peak gains may be maintained (as noted in the previous trial) throughout the follow up period.
~Enrolled subjects will commonly receive 2 treatments per week (occasionally, less or more than 1 to 2 treatments per week due to (College or University) semester breaks, exams, clinic closures and so forth) until 9 treatments are completed."
12009286|NCT00523159|Drug|Endoxana, IMA901, Leukine|a single i.v. infusion of Cyclophosphamid and then patients received vaccination therapy with intradermal (i.d.) injections of GM-CSF followed by i.d. injections of IMA901
12009287|NCT00523159|Drug|IMA901 and Leukine|Intradermal injection of GM-CSF followed by intradermal injection of IMA901
12009288|NCT00523146|Drug|Kanion Capsule|
12009289|NCT00523133|Drug|naltrexone|50 mg naltrexone daily for 3 months
12009290|NCT00523133|Drug|naltrexone|50 mg of naltrexone daily for 6 months
12009291|NCT00523133|Behavioral|Broad Spectrum Treatment|8-14, one hour sessions over 6 months
12009292|NCT00523133|Behavioral|Motivational Enhancement Treatment|4, 20 minute sessions over 3 months
12009293|NCT00523120|Drug|diclofenac sodium|topical solution used in ear 5 drops 8 3/day
12009294|NCT00523120|Drug|dexotc|aural drops
12009295|NCT00523107|Drug|PG2|PG2 500 mg / 500 ml normal saline t.i.w. per week
12009296|NCT00523107|Drug|Placebo|500 ml normal saline t.i.w. per week
12009297|NCT00523081|Behavioral|Cognitive Behavioral Therapy (CBT)|Half the teens in the study will also meet with a research counselor for five to nine individual, weekly sessions that last about 50 minutes each. Whether a teen attends the weekly counseling sessions is decided by chance, like flipping a coin. If teens are assigned to these sessions, they will learn ways to deal with stress and feel better. If teens take part in the counseling sessions, the study counselor will also talk to the teen's doctor from time to time to help plan for the best possible care.
12009298|NCT00523081|Behavioral|Active control|Teens in the active control arm will keep seeing their doctor as usual. Teens and a parent are interviewed briefly over the phone to see if they are appropriate for the study. If they qualify for the study, there is an hour-long interview with teen over the telephone and a 30 minute interview with the parent. They will be interviewed six more times in the next two years.
12009299|NCT00523068|Drug|Tolterodine|
12009300|NCT00523068|Procedure|tension free vaginal tape|
12009336|NCT00522782|Drug|Nebulized Budesonide|Pulmicort Respules 0.5mg/2cc
12009337|NCT00522782|Device|Nitric Oxide Analyzer|Niox NO analyzer
12009301|NCT00523055|Drug|Lidocaine|Lidocaine, 5 mg/kg, via needle placed adjacent to brachial plexus with ultrasound, dosing separated by 1 week, 2 doses in total, one block will contain 5 mcg/kg of adrenaline
12009302|NCT00523042|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c.
12009303|NCT00523042|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
12009304|NCT00523029|Behavioral|Chronic Disease Self-Management Program|Chronic disease self-management is a 6-week group program that teaches participants how to manage their chronic medical illness. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions.
12009305|NCT00523016|Procedure|Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)|LCCNPAP: acupuncture needle insertion at acupuncture points on the head that will be stimulated with electricity from a battery-operated Chinese acupuncture stimulation device for 20 minutes. A total of 13 treatments will be administered over 3-4 weeks.
12009306|NCT00523016|Procedure|Sham acupuncture|Sham acupuncture: Simulated acupuncture that includes insertion of acupuncture needles on the head that will be stimulated with electricity from a battery-operated Chinese acupuncture stimulation device for 20 minutes. A total of 13 treatments will be administered over 3-4 weeks. This group will be offered the LCCNPAP treatment at the completion of study participation.
12009307|NCT00523003|Dietary Supplement|high protein|2.2 g protein/kg of LBM per day
12009308|NCT00523003|Dietary Supplement|standard protein|1.1 g protein/kg LBM/day standard protein diet
12009309|NCT00522990|Drug|AT9283|Three weekly intravenous administration of AT9283
12009310|NCT00522964|Behavioral|behavioral intervention|The intervention is based on Social Cognitive Theory and principles of Chinese culture and practices. The intervention program includes a one-hour small-group session for eight weeks for children and two 2-hour small-group sessions for parents.
12009311|NCT00522951|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)
12009312|NCT00522951|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
12009313|NCT00522951|Drug|ProHance|ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
12009314|NCT00522938|Drug|CHR-2797 (tosedostat)|Once daily, oral ingestion of CHR-2797 capsules(PhaseI: 120mg, 160mg or 200mg depending on cohort or Phase II: recommended dose) capsules until progressive disease or withdrawal from the study
12009315|NCT00522938|Drug|erlotinib|Once daily, oral ingestion of erlotinib tablets 150mg tablets until progressive disease or withdrawal from the study. Per protocol, the Investigator may reduce the dose of erlotinib or cease treatment with erlotinib(per label) with Sponsor approval.
12009316|NCT00522925|Drug|PS433540|200mg capsule, once daily for 28 days
12009317|NCT00522925|Drug|placebo|placebo capsule, once daily for 28 days
12009318|NCT00522925|Drug|PS433540|500mg capsule, once daily for 28 days
12009319|NCT00522912|Procedure|Trichiasis surgery|Posterior lamella tarsal rotation
12009320|NCT00522912|Procedure|Epilation|Epilation of lashes by another well sighted person using quality epilating forceps
12009321|NCT00522899|Behavioral|Group 1|Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
12009322|NCT00522899|Behavioral|Group 2|Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
12009323|NCT00522899|Behavioral|Group 3|Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
12009324|NCT00522899|Behavioral|Group 4|Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
12009325|NCT00522886|Drug|Cetuximab|"Eligible patients will be given 2 cycles(of 21 days) of carboplatin (AUC 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. Patients without progressive disease will be entered in the phase I dose-escalation part of the study. Chest radiation will be given concurrently with cetuximab, cisplatin and vinorelbine, which will be escalated in 3 steps until dose-limiting toxicity occurs.
~14 days after the last gemcitabine (=day 43), radiotherapy is started : First 3 weeks: 1.5 Gy BID to a dose of 45 Gy in 30 fractions, then 2 Gy QD to a mean lung dose of 19 Gy. Cetuximab: 400 mg/m2 7 days before radiotherapy (= day 36) and during the course of radiotherapy a weekly dose 250 mg/m2. Cetuximab will be delivered at the same days as chemotherapy.
~Cisplatin(all steps): 50 mg/m2 days 43, 50; 40 mg/m2 day 64.
~Vinorelbine:
~Step 1: 10 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 2: 20 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 3: 20 mg/ m2 days 43, 50; 15 mg/m2 days 66 and 73."
12009326|NCT00522873|Drug|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
12009327|NCT00522873|Drug|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
12009328|NCT00522860|Procedure|Trichiasis surgery with absorbable sutures|Posterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures.
12009329|NCT00522860|Procedure|Trichiasis surgery with non-absorbable sutures|Posterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures.
12009330|NCT00522834|Drug|Elesclomol (STA-4783)|213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops
12009331|NCT00522834|Drug|Paclitaxel|80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops
12009332|NCT00522821|Drug|intravenous immunoglobulins|"Adults: 600 mg/kg bodyweight every 3 weeks
~Children: 800 mg/kg bodyweight every 3 week"
12009333|NCT00522821|Drug|antibiotics|"Children ≥5-12: If well tolerated, 4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily, every day of the week (max160/800mg/day), combined with 5 mg folic acid.
~Adults and children ≥12 years or ≥40 kg: If well tolerated, 160 mg trimethoprim and 800 mg sulfamethoxazole once daily, every day of the week combined with 5 mg folic acid."
12009334|NCT00522808|Drug|A-831|
12009338|NCT00522769|Behavioral|Cognitive Behavioral Therapy|Girls enrolled in the study will either receive the 6-20 session CBT intervention at the time of enrollment or 6 months after they enroll. Assessments including questions about eating behaviors, mood, and general functioning are given on enrollment in the study, and 3- and 6-months following enrollment (also at 9- and 12-months for those in the delayed treatment condition
12009339|NCT00522756|Drug|Sodium bicarbonate|Three ampoules of 7.5% sodium bicarbonate (89.3 mOsm/ampoule; total 150 ml for three ampoules) added to 750 ml of 5% dextrose in water, given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
12009340|NCT00522756|Drug|Sodium chloride|0.9% sodium chloride given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
12009341|NCT00522743|Drug|growth hormone and gonadotropin-releasing hormone agonist|GH & GNRHa treatment
12009342|NCT00522743|Drug|growth hormone|GH treatment
12009343|NCT00522730|Other|Parenteral nutrition|Duration : 5 days
12009344|NCT00522730|Other|Enteral nutrition|Duration : 5 days
12009345|NCT00522717|Behavioral|Cognitive Behavioral Therapy (CBT)|Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.
12009346|NCT00522717|Behavioral|Usual Care|Subjects receive Usual Care for 8 weeks followed by CBT
12009347|NCT00522704|Other|Dynamic Arterial line Pressure (DALP)|eEBF will be record with dynamic arterial line pressure of -60 mmHg (eEBF-60 mmHg), -100 mmHg (eEBF-100 mmHg), -160 mmHg (eEBF-160 mmHg), -200 mmHg (eEBF-200 mmHg) and -260 mmHg (eEBF-260 mmHg) during the first one half hour of the dialysis session. Access Blood flow will be performed with blood thermal monitor.
12009348|NCT00522691|Procedure|sacral nerve stimulation|sacral nerve stimulation for fecal incontinence
12009349|NCT00522678|Drug|GW685698X|Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS
12009350|NCT00522678|Drug|Placebo|Subject will receive Placebo matching GW685698X via DISKUS.
12009351|NCT00522665|Drug|Irinotecan|Irinotecan 125 mg/m2 IV days 1 and 8
12009352|NCT00522665|Biological|Cetuximab|Cetuximab 250mg/m2 IV days 1, 8 and 15
12009353|NCT00522665|Biological|RAD001|Patients on Arm A will crossover and receive RAD001 at disease progression
12009354|NCT00522652|Drug|PX-478|Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity
12009355|NCT00522639|Other|18F-deoxyglucose (FDG)|contrast medium
12009356|NCT00522626|Device|Maternal fetal monitoring|Simultaneous monitoring of maternal and fetal physiology
12009357|NCT00522613|Behavioral|Recovery Group Project|Recovery Group Workbook & Group Sessions
12009358|NCT00522587|Drug|Fixed sevoflurane dose 1|Dose 1 of sevoflurane
12009359|NCT00522587|Drug|Fixed sevoflurane dose 2|Dose 2 of sevoflurane
12009360|NCT00522587|Drug|Fixed sevoflurane dose 3|Dose 3 of sevoflurane
12009361|NCT00522587|Drug|Fixed sevoflurane dose 4|Dose 4 of sevoflurane
12009362|NCT00522587|Drug|Fixed sevoflurane dose 5|Dose 5 of sevoflurane
12009363|NCT00522587|Drug|Fixed sevoflurane dose 6|Dose 6 of sevoflurane
12009364|NCT00522587|Drug|Fixed remifentanil dose 1|Dose 1 of remifentanil
12009365|NCT00522587|Drug|Fixed remifentanil dose 2|Dose 2 of remifentanil
12009366|NCT00522587|Drug|Fixed remifentanil dose 3|Dose 3 of remifentanil
12009367|NCT00522587|Drug|Fixed remifentanil dose 4|Dose 4 of remifentanil
12009368|NCT00522587|Drug|Fixed remifentanil dose 5|Dose 5 of remifentanil
12009369|NCT00522587|Drug|Fixed remifentanil dose 6|Dose 6 of remifentanil
12009370|NCT00522574|Drug|XL019|gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths
12009371|NCT00522561|Other|energetic and non invasive limb mechanical measurements|Force velocity stiffness running
12009372|NCT00522548|Drug|Enteric coated mycophenolate sodium|Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.
12009373|NCT00522548|Drug|Mycophenolate mofetil|Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent formulation manufactured by Sandoz, in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.
12009374|NCT00522535|Procedure|Open surgical repair|Open surgical repair of abdominal aortic aneurysm
12009375|NCT00522535|Device|Stent Graft|Endovascular repair of abdominal aortic aneurysm (EVAR)
12009376|NCT00522509|Drug|Floxuridine FUDR|
12009377|NCT00522470|Drug|rosiglitazone|
12009378|NCT00522457|Drug|ertumaxomab|Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate.
12009379|NCT00522444|Drug|Nebulized Magnesium Sulfate|6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate
12009380|NCT00522444|Other|Nebulized normal saline|standard of care
12009381|NCT00522431|Drug|Testosterone|2% gel
12009382|NCT00522418|Device|Vagal Nerve Simulation (VNS) Therapy|VNS Therapy + Best Medical Practice including anti-epileptic drugs
12009383|NCT00522418|Drug|Best Medical Practive|Best Medical Practice including anti-Epileptic Drugs
12009384|NCT00522405|Procedure|TACE|"Under local anesthesia, the Femoral artery would be punctured
~A catheter would be introduced and a flush aortogram, superior mesenteric arterioportography and the celiac artery run would be undertaken to define the size and location of the tumors, feeding vessels and to assess the portal vein patency
~Superselective catheterization of the hepatic artery feeding the tumor would be done
~By placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered.
~Stable drug mixture would be prepared by using Doxorubicin 50mg, Cisplatin 100mg in combination with 10-15ml of ionic contrast media and 10-20ml of lipiodol by continuously agitating the mixture.
~The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-luer locks syringes connected across a three way.
~Gelfoam particles would be injected following this for embolization"
12009385|NCT00522392|Drug|bortezomib|Given IV
12009386|NCT00522392|Drug|lenalidomide|Given PO
12009388|NCT00522379|Drug|Rotigotine|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
12009389|NCT00522379|Drug|Rotigotine|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
12009390|NCT00522379|Other|Placebo|Placebo transdermal patch applied daily
12009391|NCT00522379|Drug|Rotigotine|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
12009392|NCT00522379|Drug|Rotigotine|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
12009393|NCT00522353|Dietary Supplement|Oligofructose|21 grams per day in distributed over 3 doses per day for 3 months
12009394|NCT00522353|Dietary Supplement|Placebo|7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months
12009395|NCT00522340|Behavioral|Aerobic Exercise Program|Home walking 1 hour a day for 5 days/week for 8 weeks. Then 30 minutes a day on all or most days of the week.
12009396|NCT00522327|Other|remote simultaneous medical interpreting|remote simultaneous medical interpretation
12009397|NCT00522327|Other|usual and customary|usual and customary interpreting
12009398|NCT00522327|Other|ENglish speaking|English speakers
12009399|NCT00522314|Device|NIV and ACBT|
12009400|NCT00522314|Other|Active Cycle of Breathing Techniques|
12009401|NCT00522301|Drug|sorafenib tosylate|
12009402|NCT00522301|Other|immunoenzyme technique|
12009403|NCT00522301|Other|immunohistochemistry staining method|
12009404|NCT00522301|Other|laboratory biomarker analysis|
12009405|NCT00522301|Other|pharmacological study|
12009406|NCT00522288|Device|Soft contact lenses|Daily wear soft contact lenses disposed of daily or biweekly
12009407|NCT00522288|Device|Spectacle|Spectacles for the treatment of myopia
12009408|NCT00522275|Drug|lacosamide|50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
12009409|NCT00522262|Behavioral|Aerobic exercise intervention|Women in the exercise arm underwent a year-long exercise intervention of five days per week of 45 minutes/session of moderate-vigorous intensity aerobic exercise.
12009410|NCT00522249|Drug|Pegylated Alfa Interferon|Each patient will receive PEG-Intron administered subcutaneously one day per week of each 6 week cycle. The dose of PEG-Intron is determined based on the patient's weight and the dose level.
12009411|NCT00522249|Drug|sunitinib|Patients will receive sunitinib orally as a single daily dose on Days 1-28 of each 42-day cycle. The dose will depend on the dose level.
12009412|NCT00522249|Drug|erlotinib|Tarceva will be administered orally, 1-42 of each 42 day cycle. Dose will depend on dose level. Supplied as 150-mg, 100-mg and 25-mg strengths, white film-coated tablets for administration.
12009413|NCT00522236|Biological|Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008|"A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:
~A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain)
~A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain)
~B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season.
~The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.
~A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm."
12009414|NCT00522223|Behavioral|Questionnaire|"Participants who are treated with radiation therapy: Questionnaires 5 times.
~Participants who undergo a radical hysterectomy: Questionnaires 4 times."
12009415|NCT00522210|Drug|Detemir|Patients will discontinue their usual bedtime dose of intermediate acting insulin and replace this with the same unit dose of detemir at supper time. The detemir will not be mixed with the rapid acting insulin and will be given as a separate injection. The patient's morning dose of intermediate acting insulin will be decreased by 20% to adjust for the longer duration of action of detemir. Doses of rapid acting insulin will remain the same at breakfast and at supper.
12009416|NCT00522210|Other|Novolin NPH or Humulin N|Patients will continue on their usual insulin regimen of insulin three times per day. Intermediate and rapid acting insulin at breakfast, rapid acting insulin at supper, and intermediate acting insulin at bedtime.
12009417|NCT00522197|Dietary Supplement|multi-herbal agent ACAPHA|
12009418|NCT00522197|Dietary Supplement|Sugar Pill|
12009419|NCT00522184|Procedure|intra-articular injection of etanercept|
12009420|NCT00522184|Procedure|intra-articular injection of steroid|
12009421|NCT00522171|Device|The Harmonic™ ultrasonic scalpel|A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
12009422|NCT00522158|Drug|simvastatin|
12009423|NCT00522158|Drug|atorvastatin|
12009424|NCT00522145|Drug|XL647|Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets
12009425|NCT00522132|Drug|Artesunate|intravenous application
12009426|NCT00522106|Behavioral|Behavioral graded activity|The intervention is directed at increasing the level of activities in a time-contingent way, with the goal to integrate these activities in the daily living of the patients. The intervention is performed by physical therapists in primary care, on individual basis. Treatment period of maximal 12 weeks (with maximal 18 sessions), followed by 5 pre-set boostermoments with a maximum of 7 sessions (respectively in week 18, 25, 34, 42, and 55).
12009427|NCT00522106|Other|Exercise therapy|Treatment according to the Dutch physiotherapy guideline for patients with osteoarthritis of hip and/or knee. This guideline consists of general recommendations, emphasizing provision of information and advice, exercise therapy, and encouragement of a positive coping with the complaints. The treatment consisted of a maximum of 18 sessions within a period of 12 weeks. The treatment could be discontinued within the 12 week period if, according to the physiotherapists, all treatment goals were achieved.
12009428|NCT00522093|Drug|TJ-100|TJ-100 2.5g three times per day for 6 weeks
12009429|NCT00522067|Biological|Adjuvanted influenza vaccine|Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine
12009430|NCT00522054|Other|Physical exercise|Tai Chi exercise, twice a week during 12 weeks
12009431|NCT00522041|Drug|Cellegesic|Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.
12010482|NCT00513981|Other|pharmacological study|
12009432|NCT00522041|Drug|Placebo|Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.
12009433|NCT00522015|Drug|rivastigmine|rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day
12009434|NCT00521989|Drug|CRx-102 (2.7/90)|CRx-102 dose 1
12009435|NCT00521989|Drug|Prednisolone|Prednisolone
12009436|NCT00521989|Drug|Placebo|Placebo
12009437|NCT00521989|Drug|CRx-102 (2.7/180)|CRx-102 dose 2
12009438|NCT00521989|Drug|CRx-102 (2.7/360)|CRx-102 dose 3
12009439|NCT00521963|Biological|Intraarticular injection of infliximab|A single injection of 100 mg of infliximab
12009440|NCT00521950|Genetic|TPMT genotyping; Drug: azathioprine or 6-mercaptopurine|"Assessment of the polymorphisms G238C, G460A, and A719G in a venous blood sample to identify functional genetic variants (TPMT*2, *3A, *3C) of the TPMT gene (chromosome 6) associated with reduced or negligible TPMT enzyme activity.
~Patients are advised an initial treatment dose based on the enzyme activity:
~Normal: AZA 2-2.5 mg/kg/day or 6-MP 1-1.5 mg/kg/day (standard care);
~Reduced: AZA 1-1.25 mg/kg/day or 6-MP 0.5-0.75 mg/kg/day;
~Negligible: AZA 0-0.2 mg/kg/day or 6-MP 0-0.1 mg/kg/day;"
12009441|NCT00521950|Drug|azathioprine (AZA) or 6-mercaptopurine (6-MP)|"Patients will be advised a standard initial treatment dose:
~AZA 2-2.5 mg/kg/day or 6-MP 1-1.5 mg/kg/day (standard care);"
12009442|NCT00521937|Other|Dermagen®|Weekly topical applications
12009443|NCT00521924|Biological|infliximab|infliximab 3 mg/kg and basic treatment
12009444|NCT00521924|Drug|DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.|Methotrexate (15 - 25 mg/week); chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89
12009445|NCT00521911|Behavioral|Cognitive Behavioural Therapy|
12009446|NCT00521898|Procedure|Descemet Membrane Endothelial Keratoplasty (DMEK)|
12009447|NCT00521885|Drug|Arixtra (Fondaparinox) 2.5 mg SC Daily|Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm
12009448|NCT00521885|Drug|Lovenox 40mg SC Daily|Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm
12009449|NCT00521872|Procedure|STARR Operation|
12009450|NCT00521859|Drug|Cloretazine|800 mg/m^2 by vein daily
12009451|NCT00521859|Drug|Fludarabine|25 mg/m^2 by vein daily x 5 Days
12009452|NCT00521846|Device|Biomet Explor Modular Radial Head Replacement|As part of the patient's routine care, they will undergo a radial head replacement using the Biomet Explor Modular Radial Head system.
12009453|NCT00521833|Procedure|phacoemulsification and intraocular lens implantation|clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively
12009454|NCT00521820|Drug|Pioglitazone|Pioglitazone 30 mg (titrated to 45mg with tolerance), tablets, orally once daily and glyburide placebo-matching tablets, orally, once daily for up to 24 weeks.
12009455|NCT00521820|Drug|Glyburide|Pioglitazone placebo-matching tablets, orally, once daily and glyburide 10 mg (titrated to 15mg with tolerance), capsules, orally, once daily for up to 24 weeks.
12009456|NCT00521807|Procedure|Hypnosis|a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week,
12009457|NCT00521781|Drug|Abraxane|100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.)
12009458|NCT00521781|Drug|Leuprolide|7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years
12009459|NCT00521781|Drug|Bicalutamide|50 mg p.o. daily starts week 36 of initiating Abraxane.
12009460|NCT00521768|Behavioral|Prolonged exposure|
12009461|NCT00521755|Device|Seraffix LTB|laser soldering for soft tissue wounds
12009462|NCT00521742|Drug|Pioglitazone|Pioglitazone 15 mg to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 52 weeks.
12009463|NCT00521742|Drug|Glyburide|Glyburide 2.5 mg to 15 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
12009464|NCT00521742|Drug|Pioglitazone|Pioglitazone 15 mg or 30 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally once daily for up to 52 weeks.
12009465|NCT00521742|Drug|Glyburide|Glyburide 5 mg or 10 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally once daily for up to 52 weeks.
12009466|NCT00521729|Procedure|Exposure to Cold Temperature|
12009467|NCT00521716|Device|Intracapsular Femoral Fracture Fixation|The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
12009468|NCT00521716|Device|WaisFix100i for Intracapsular Femoral Fracture Fixation|The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
12009469|NCT00521703|Drug|Lidocaine|oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
12009470|NCT00521703|Drug|Tannic acid|oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing
12009471|NCT00521690|Drug|insulin detemir|
12009472|NCT00521677|Procedure|Sage oral care|Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID
12009473|NCT00521677|Procedure|Traditional oral care|Cleaning of oral cavity with menthol solution, TID
12009474|NCT00521664|Biological|Prophylactic platelet transfusion|In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.
12009475|NCT00521664|Biological|Therapeutic platelet transfusion|In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.
12009476|NCT00521638|Biological|TRU-015|Intravenous administration; 400 mg, 700 mg, or 1000 mg; 1x/week dosing for 4 weeks
12009477|NCT00521612|Drug|sevoflurane|Volatile anaesthetic sevoflurane 1 MAC (2,0 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic sevoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic sevoflurane. Change will be +10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.
12010538|NCT00513630|Drug|Metformin|
12009478|NCT00521612|Drug|isoflurane|Volatile anaesthetic isoflurane 1 MAC (1,2 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic isoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic isoflurane. Change will be +10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.
12009479|NCT00521599|Drug|Mometasone furoate dry powder inhaler|
12009480|NCT00521599|Drug|Placebo|
12009481|NCT00521586|Biological|13 valent pneumococcal conjugate vaccine|TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
12009482|NCT00521586|Biological|13 valent pneumococcal conjugate vaccine|TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
12009483|NCT00521573|Other|Dark chocolate|
12009484|NCT00521560|Drug|Zevalin|"All applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively.
~High dose therapy will be given as BEAM"
12009485|NCT00521547|Procedure|Electroacupuncture|
12009486|NCT00521534|Device|CRT with atrial overdrive pacing|Both groups receive CRT, one group receives atrial overdrive pacing
12009487|NCT00521521|Drug|docetaxel and cisplatin|
12009488|NCT00521521|Drug|docetaxel|
12009489|NCT00521508|Procedure|gene transcription and cytometry|samply of 30 ml of blood
12009490|NCT00521495|Device|neodymium permanent magnet|"3/4 diameter by 1/8 thick permanent magnet"
12009491|NCT00521495|Device|neodymium magnet|A. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target
12009492|NCT00521495|Device|magnet|0 Gauss magnets are worn every night during hours of sleep for 6 weeks.
12009493|NCT00521482|Drug|Temozolomide|
12009494|NCT00521482|Drug|Temozolomide plus Thalidomide|
12009495|NCT00521469|Device|Pro Adjuster|
12009496|NCT00521456|Drug|ketorolac eye drops|"1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day
~Placebo"
12009497|NCT00521443|Procedure|Cryopreservation, thawing and blastocyst culture|Good quality human embryos were frozen - thawed and cultured to the blastocyst stage.
12009498|NCT00521430|Biological|anti-thymocyte globulin|
12009499|NCT00521430|Drug|busulfan|
12009500|NCT00521430|Drug|cyclosporine|
12009501|NCT00521430|Drug|fludarabine phosphate|
12009502|NCT00521430|Drug|methotrexate|
12009503|NCT00521430|Drug|methylprednisolone|
12009504|NCT00521430|Procedure|allogeneic hematopoietic stem cell transplantation|
12009505|NCT00521430|Procedure|peripheral blood stem cell transplantation|
12009506|NCT00521417|Behavioral|short-term dynamic therapy|
12009507|NCT00521417|Behavioral|long-term dynamic therapy|
12009508|NCT00521404|Drug|CS-1008 (humanized anti-DR5 antibody)|CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
12009509|NCT00521404|Drug|gemcitabine|Gemcitabine - 1000mg/meter sq
12009510|NCT00521391|Other|Allez Hop|a tailored physical activity intervention involving moderate-intensity exercise
12009511|NCT00521365|Drug|Quetiapine 600mg|"300 mg quetiapine fumarate tablets for oral use.
~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day."
12009512|NCT00521352|Device|Active Repetitive Transcranial Magnetic Stimulation (rTMS)|Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks.
12009513|NCT00521352|Device|Sham Repetitive Transcranial Magnetic Stimulation (rTMS)|Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain.
12009514|NCT00521339|Drug|Apremilast|20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.
12009515|NCT00521300|Drug|Octreotide|First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months
12009516|NCT00521300|Procedure|Direct surgery for acromegaly|Direct transsphenoidal surgery
12009517|NCT00521287|Other|Immune profiling and DC vaccine|"For observational study (immune profiling): blood sampling 3-5 mL
~For DC vaccine: one dose of DC vaccine(~10 million cells)/2 week for at least 6 month or until progression."
12009518|NCT00521274|Biological|MVA 5T4|Docetaxel will be administered at the completion of the first three TroVax® injections. Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients will receive up to 10 total Docetaxel infusions over the course of the study. Subsequent TroVax® injections will be delivered on Day 1 of each Docetaxel cycle, 2 hours prior to the chemotherapy administration.
12009519|NCT00521274|Drug|Docetaxel|Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). Patients will receive up to 10 total Docetaxel infusions over the course of the study. If patients cross-over, TroVax® will be administered 2 hours prior to the chemotherapy administration.
12009520|NCT00521261|Biological|anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells|
12009521|NCT00521248|Drug|buprenorphine|sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
12009522|NCT00521248|Drug|Oral morphine solution|0.4 mg/kg/day morphine every 4 hours
12009523|NCT00521222|Drug|Fluticasone with salmeterol|Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
12009524|NCT00521222|Drug|Fluticasone HFA|Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
12009572|NCT00520923|Drug|LY2140023|40mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
12009573|NCT00520923|Drug|LY2140023|20mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
12009525|NCT00521209|Behavioral|Self-Care Stimulating Disease Prevention Program (SCSDPP)|"The SCSDPP development is guided by the following premises: a) patient-directed lifestyle change or self-prescription of behavior change is potentially a more empowering, sustainable, and proactive approach to addressing personal health habits than the more conventional physician-directed approach; b) patient-directed lifestyle change or self-prescription of behavior change is potentially an important predictor of self-efficacy and long-term adherence to healthy habits; c) behavior change in isolation is less sustainable than change that is reinforced by other distinct but related changes (e.g., the potential synergy of improving diet and physical activity concurrently to prevent chronic disease); d) a multi-level change directed at the service delivery system and physician support, however small, has the added benefit of potentially reducing provider and staff burden while maximizing available clinic and community resources; and f) brief physician counseling"
12009526|NCT00521209|Other|Stand procedures, no intervention|
12009527|NCT00521196|Device|DC Stimulator (Transcranial Direct Current Stimulator)|Subjects will receive a total of 10 sessions of either active tDCS or sham tDCS over a four-week period (administered every other day during weekdays over the course of one month). During each tDCS session, two electrodes are placed over selected areas of the brain. The anode is placed on the motor cortex contralateral to the side where migraines predominant; the cathode is placed near the supraorbital area, opposite the anode. A small battery powered device drives 2 mA of direct current through the two electrodes. The direct current will flow through the electrodes, penetrate the scalp, and create a flow of electrical current in the brain. The procedure will last 20 minutes. For sham tDCS, an alternate method of stimulation will be used.
12009528|NCT00521183|Drug|Cytochlor|The study's starting dose of CldC is 50 mg/m2/day. The dose of CldC will be escalated / de-escalated for patients. Patients will receive CldC+H4U on 3 days (Wed, Thr, Fri) in week 1, which precedes the initiation of radiation therapy. Patients will receive H4U and CldC IV by bolus infusion. Treatment with CldC+H4U will then continue for 5 days (Mon-Fri) during each of weeks 2 and 3, and will be accompanied by radiation therapy at 3 Gy/fraction initiated 3-4 h after bolus infusion of CldC+H4U. Treatment with CldC+H4U and radiation will then stop at the end of week 3.
12009529|NCT00521183|Drug|Tetrahydrouridine|A fixed dose of H4U at 720 mg/m2/day will be used, regardless of the dose of CldC administered. H4U will be delivered by an IV bolus infusion over a period of 5 minutes, followed 5 minutes later by an IV bolus infusion of CldC. Patients will receive CldC+H4U on 3 days (Wed, Thr, Fri) in week 1, which precedes the initiation of radiation therapy. Patients will receive H4U and CldC IV by bolus infusion. Treatment with CldC+H4U will then continue for 5 days (Mon-Fri) during each of weeks 2 and 3, and will be accompanied by radiation therapy at 3 Gy/fraction initiated 3-4 h after bolus infusion of CldC+H4U. Treatment with CldC+H4U and radiation will then stop at the end of week 3.
12009530|NCT00521183|Radiation|Radiation Therapy|One treatment of 3 Gy will be given daily 5 days per week (10 fractions) for a total of 30 Gy over two weeks.
12009531|NCT00521170|Drug|Levocetirizine|
12009532|NCT00521157|Drug|Go Medical Naltrexone implants|Naltrexone implants 3.2 g (double of 1,6 g)
12009533|NCT00521144|Drug|obatoclax mesylate|Given IV
12009534|NCT00521144|Drug|topotecan hydrochloride|Given IV
12009535|NCT00521144|Other|laboratory biomarker analysis|Correlative studies
12009536|NCT00521131|Drug|Levocetirizine dihydrochloride|
12009537|NCT00521118|Other|Laboratory Biomarker Analysis|Correlative studies
12009538|NCT00521118|Procedure|Therapeutic Conventional Surgery|Undergo second curettage
12009539|NCT00521105|Other|Virtual visit|Participants will alternate between a multidisciplinary visit (MD, RN and RD) and a phone contact with the diabetes nurse educator (the phone contact will replace the physician-only visit). Prior to the phone contact, transmission of information from the participant will be sent through either fax or a web browser.
12009540|NCT00521092|Drug|sunitinib malate|Given orally
12009541|NCT00521092|Procedure|laboratory biomarker analysis|Correlative study
12009542|NCT00521092|Procedure|pharmacological study|Correlative study
12009543|NCT00521079|Device|Therapy ON|Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)
12009544|NCT00521079|Device|Therapy OFF|Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)
12009545|NCT00521066|Device|GYNECARE PROSIMA* Pelvic Floor Repair System|procedure for pelvic organ prolapse
12009546|NCT00521053|Drug|PV-10 (10% rose bengal disodium)|Intralesional injection for chemoablation
12009547|NCT00521040|Drug|Levocetirizine dihydrochloride|
12009548|NCT00521027|Device|Versajet Hydrosurgery System|Debridement with Versajet Hydrosurgery System
12009549|NCT00521027|Procedure|Conventional surgical debridement techniques|Conventional surgical debridement with scalpel and pulse lavage
12009550|NCT00521014|Biological|filgrastim|
12009551|NCT00521014|Biological|rituximab|
12009552|NCT00521014|Biological|sargramostim|
12009553|NCT00521014|Drug|carmustine|
12009554|NCT00521014|Drug|cytarabine|
12009555|NCT00521014|Drug|etoposide|
12009556|NCT00521014|Drug|melphalan|
12009557|NCT00521014|Procedure|autologous hematopoietic stem cell transplantation|
12009558|NCT00521001|Drug|everolimus|
12009559|NCT00521001|Drug|temozolomide|
12009560|NCT00520988|Behavioral|Use of telephone-based Interactive Voice Recognition system|Use of telephone-based Interactive Voice Recognition system, for reporting of health information and blood pressure measurements
12009561|NCT00520975|Biological|Bevacizumab|Given IV
12009562|NCT00520975|Drug|Carboplatin|Given IV
12009563|NCT00520975|Drug|Paclitaxel|Given IV
12009564|NCT00520975|Other|Placebo|Given IV
12009565|NCT00520975|Biological|Trastuzumab|Given IV
12009566|NCT00520949|Drug|Augmentin (Amoxicillin-clavulanic)|Amoxicillin-clavulanic acid 1 gram b.i.d
12009567|NCT00520949|Drug|Furoxone (furazolidone)|furazolidone 200 mg b.i.d
12009568|NCT00520949|Drug|Cebes (colloidal bismuth subcitrate)|colloidal bismuth subcitrate 240 mg b.i.d
12009569|NCT00520949|Drug|Esso (esomeprazole)|esomeprazole 40 mg b.i.d for 14 days
12009570|NCT00520936|Drug|pemetrexed|1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles
12009571|NCT00520923|Drug|LY2140023|80mg, PO (by mouth) BID (twice a day) for up to 4 weeks.
12009574|NCT00520923|Drug|LY2140023|5mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
12009575|NCT00520923|Drug|Olanzapine|10mg, PO (by mouth) QPM (every evening) for the first 3 days, then 15mg PO QPM, for up to 4 weeks.
12009576|NCT00520923|Drug|Placebo|Taken PO (by mouth) QAM (every morning) for up to 4 weeks.
12009577|NCT00520923|Drug|Placebo|Taken PO (by mouth) BID (twice daily) for up to 4 weeks.
12009578|NCT00520910|Drug|Polypodium leucotomos|Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.
12009579|NCT00520897|Drug|Raltegravir (MK0518)|400mg BID; 48 weeks
12009580|NCT00520897|Drug|Placebo|400mg QD
12009581|NCT00520897|Procedure|Leukopheresis|pack of cells as per protocol
12009582|NCT00520897|Procedure|Sigmoid Biopsy|gut samples as per protocol
12009583|NCT00520884|Drug|Ghrelin Infusion - Healthy|At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
12009584|NCT00520884|Drug|Ghrelin Infusion - Frail|At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min will be infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
12009585|NCT00520884|Other|Placebo Infusion -Healthy|At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
12009586|NCT00520884|Other|Placebo Infusion - Frail|At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
12009587|NCT00520871|Drug|Blueberry juice|
12009588|NCT00520858|Other|Resistance Exercise (RE)|
12009589|NCT00520858|Other|Aerobic Exercise (AE)|
12009590|NCT00520858|Other|Resistance and Aerobic Exercise (RAE)|
12009591|NCT00520845|Drug|celecoxib|600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
12009592|NCT00520845|Drug|Docetaxel|75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
12009593|NCT00520845|Drug|pemetrexed disodium|500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
12009594|NCT00520845|Other|laboratory biomarker analysis|Blood collection
12009595|NCT00520832|Device|Microcurrent|20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
12009596|NCT00520832|Device|Microcurrent|Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.
12009597|NCT00520819|Drug|Antioxidant-rich food items|
12009598|NCT00520806|Drug|Relaxin|Intravenous infusion for 48 h at 30 ug/kg/day
12009599|NCT00520806|Drug|Placebo|Intravenous infusion for 48 h
12009600|NCT00520780|Drug|Ferinject ® (Ferric carboxymaltose)|"Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.
~After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase)."
12009601|NCT00520780|Drug|Normal saline (0.9%)|During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.
12009602|NCT00520767|Drug|bortezomib|Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
12009603|NCT00520767|Drug|dexamethasone|Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
12009604|NCT00520767|Drug|melphalan|Melphalan 9 mg/m2/day days 1-4
12009605|NCT00520767|Genetic|microarray analysis|≤28 days prior to enrollment
12009606|NCT00520767|Other|flow cytometry|Day 1 of cycles 6, 12, 18 and at end of study.
12009607|NCT00520767|Other|laboratory biomarker analysis|≤28 days prior to enrollment
12009608|NCT00520767|Procedure|quality-of-life assessment|Start of each cycle
12009609|NCT00520754|Drug|levocetirizine dihydrochloride|
12009610|NCT00520741|Drug|Lacosamide|50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
12009611|NCT00520741|Drug|Lacosamide|50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
12009612|NCT00520728|Behavioral|Occupational Time Use Intervention|12 week behavioral intervention administered by Occupational Therapists.
12009613|NCT00520702|Procedure|Intensity Modulated Radiation Therapy|66 Gy in 33 Daily Fractions at 2 Gy per fraction.
12009614|NCT00520702|Procedure|3-Dimensional Conformal Radiation Therapy|66 Gy in 33 Daily Fractions at 2 Gy per fraction.
12009615|NCT00520689|Device|Silicone Hydrogel Contact Lens|use of lens over 2 days
12009616|NCT00520676|Drug|pemetrexed|500 mg/m^2, IV, q 21 days x 6 cycles maximum
12009617|NCT00520676|Drug|docetaxel|75 mg/m^2, IV, q 21 days x 6 cycles maximum
12009618|NCT00520676|Drug|carboplatin|AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
12009619|NCT00520663|Drug|14C-SB649868|SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water.
12009620|NCT00520650|Drug|Aripiprazole|
12009621|NCT00520637|Drug|EZN-2208|
12009622|NCT00520624|Device|inspiratory muscle strength training|
12009623|NCT00520624|Procedure|Surgery|
12009624|NCT00520611|Behavioral|Financial Incentives|Participants call in their weight on daily basis. Participants must report under their daily targets to qualify for entry into lottery. Call-in weights are verified at monthly weigh-ins.
12009625|NCT00520611|Behavioral|Financial Incentives|Participants call in their weight on daily basis. Participants must report under their daily targets to qualify to receive daily incentive. Call-in weights are verified at monthly weigh-ins.
12009694|NCT00520091|Radiation|Radiation|4,500 cGy in 180 cGy fractions 5 days per week, over a period of 5 weeks
12009626|NCT00520598|Biological|Comparator: V505 formulation 1|0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
12009627|NCT00520598|Drug|Comparator: V505 formulation 2|0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
12009628|NCT00520598|Drug|Comparator: V505 formulation 2|0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
12009629|NCT00520598|Biological|Comparator: V505 formulation 3|0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
12009630|NCT00520598|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant|0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
12009631|NCT00520598|Biological|Comparator: Placebo (unspecified)|0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
12009632|NCT00520585|Drug|atorvastatin|atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo
12009633|NCT00520572|Drug|AZD9056|
12009634|NCT00520572|Drug|Etanercept|
12009635|NCT00520572|Drug|Placebo|
12009636|NCT00520546|Other|18F-Ethylcholine Positron Emission Tomography (FEC-PET)|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. After a short gap due to computer processing time the whole body scan was performed starting at the upper thoracic aperture down to the proximal femur. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
12009637|NCT00520546|Other|Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2w spin echo (SE) sagittal, transversal and coronal sequences were acquired.
12009638|NCT00520533|Biological|Chimeric monoclonal antibody cG250|"First Cycle: cG250 10 mg/m² intravenous infusion, weekly for five weeks, followed by a two-week break. 1st & 5th dose will be trace-labeled with a radioactive substance detectable on a PET scanner (¹²⁴I-cG250)
~Second cycle (investigator discretion): cG250 10 mg/m² intravenous infusion, weekly for four weeks followed by a two-week break. No ¹²⁴I-cG250 will be used in the 2nd cycle.
~Up to 2 cycles available."
12009639|NCT00520533|Drug|Sunitinib malate|"First Cycle: Sunitinib 50 mg orally daily for 4 weeks (starts 8th day of 1st treatment cycle), followed by a two-week period off sunitinib.
~Second cycle (investigator discretion): Sunitinib 50 mg orally daily for 4 weeks (starts on 1st day of 2nd treatment cycle), followed by a two-week period off sunitinib.
~Up to 2 cycles available on-study."
12009640|NCT00520507|Drug|Olanzapine|Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.
12009641|NCT00520507|Drug|Placebo|An inactive form of the treatment will be taken once daily at 6pm for 1 month.
12009642|NCT00520494|Drug|Vivaglobin|Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.
12009643|NCT00520481|Drug|IMC-A12 (Cixutumumab)|10 mg/kg i.v. infusion over 1 hour every 2 weeks or 20 mg/kg i.v. infusion over 1 hour every 3 weeks.
12009644|NCT00520468|Drug|Erythropoietin|40,000 units injected under the skin (SQ) weekly
12009645|NCT00520468|Drug|Cyclosporin A|300 mg (tablets) by mouth daily for 6 months
12009646|NCT00520468|Drug|G-CSF|300 mcg injected under the skin (SQ) two times per week
12009647|NCT00520468|Drug|Prednisone|60 mg per day for 7 days, taper over 1 month
12009648|NCT00520455|Drug|levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms|levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse
12009649|NCT00520442|Drug|ibuprofen|
12009650|NCT00520442|Drug|acetamin w codeine|
12009651|NCT00520429|Behavioral|ACCES - Adjusting to Chronic Conditions with Education and Support|The primary objective of this research is to pilot test a brief mental heath treatment specifically tailored to meet the needs of chronically ill patients with anxiety and/or depression. Using an open-trial format, the proposed study will examine the feasibility of a brief psychosocial intervention. Primary outcomes will assess intervention effects on patient and clinician rated symptoms of anxiety and depression. If proven feasible and effective among this group of participants, the intervention (due to its brief format and focus on medically ill patient needs) will possess unique characteristics that will increase the ability of medical care settings to implement mental health treatments, and will provide valuable pilot data for the development of a larger research project to determine the efficacy of this intervention among a larger group of chronically ill patients relative to usual care.
12009652|NCT00520416|Procedure|Carbon dioxide angiogram|see description of procedure
12009653|NCT00520403|Drug|bevacizumab [Avastin]|15mg/kg iv every 3 weeks
12009654|NCT00520403|Drug|Interferon alfa-2a|3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
12009655|NCT00520403|Drug|Vinblastine|0.1mg/kg iv every 3 weeks
12009656|NCT00520390|Drug|EZN-2208|
12009657|NCT00520377|Drug|MD05|recombinant human GDF-5 coated onto beta-tricalcium phosphate
12009658|NCT00520377|Device|Beta-TCP and autologous bone|beta-tricalcium phosphate and autologous bone
12009659|NCT00520364|Other|Observation of IVF outcomes in relation to chemo history and AMH|Women undergoing IVF with or without history of chemotherapy, AMH levels compared
12009660|NCT00520351|Drug|ClearCare|contact lens care system
12009661|NCT00520351|Drug|Optifree Replenish|contact lens care system
12009662|NCT00520338|Drug|celecoxib|"placebo
~celecoxib 400 mg oral single dose"
12009663|NCT00520325|Drug|Intravenous recombinant human mannose binding lectin|Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12009695|NCT00520091|Procedure|Surgery|Surgery will occur prior to chemoradiation therapy for those patients with resectable disease
12009664|NCT00520325|Drug|Intravenous recombinant human mannose binding lectin|Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12009665|NCT00520299|Drug|ADI PEG 20|Intramuscular injections were administered into the deltoid, gluteal, or quadricep muscles once weekly (± 2 days) for 9 weeks during cycle 1 and 8 weeks during subsequent cycles
12009666|NCT00520286|Drug|Modafinil|200 mg or 400 mg /daily
12009667|NCT00520286|Drug|Placebo|Placebo / daily
12009668|NCT00520273|Device|cobas s 201 TaqScreen MPX Test|Donors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician.
12009669|NCT00520260|Drug|bromfenac|0.09%, BID, 6 weeks
12009670|NCT00520260|Drug|ketorolac|0.4%, BID, 6 weeks
12009671|NCT00520247|Drug|enalapril plus folic acid|enalapril 10.0 mg daily for 8 weeks (the control group); enalapril 10.0 mg plus folic acid 0.4 mg daily for 8 weeks (Low-dose group); enalapril 10.0 mg plus folic acid 0.8 mg daily for 8 weeks (High-dose group)
12009672|NCT00520234|Drug|Caspofungin|50 mg IV daily
12009673|NCT00520234|Drug|Normal Saline|100 cc IV daily
12009674|NCT00520208|Drug|Tamibarotene|For induction therapy, tamibarotene will be self-administered via tablets on an outpatient basis at a dose of 6 mg/m2 per day, taken orally, in two divided doses approximately one hour after breakfast and dinner. Induction therapy will continue for a maximum of 56 days until either a morphologic leukemia-free state or complete response (CR) has been achieved. For patients who achieve a CR with induction therapy, consolidation therapy will commence 4 to 8 weeks after the end of induction therapy. For patients who have a morphologic leukemia-free state after induction therapy but who fail to achieve a CR, consolidation therapy will commence 8 weeks after the end of induction therapy.
12009675|NCT00520195|Behavioral|Physical activity|Climbing stairs instead of taking elevators at worksite during 12 weeks.
12009676|NCT00520182|Behavioral|MUFA diet|Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). MUFA diet included only low glycemic index carbohydrates. The diet consisted of 35% carbohydrates and 45% fat (50% of them were mono-unsaturated fatty acids [MUFA]). Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.
12009677|NCT00520182|Behavioral|ADA 2003|Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). The carbohydrates are with mixed glycemic index. The diet contains 50-55% carbohydrates, 30% fat and 15-20% protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.
12009678|NCT00520182|Behavioral|Low Glycemic index (LGI) diet|Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). LGI diet included only low glycemic index carbohydrates. The diet consisted of 50-55% carbohydrates, 30% fat and 20%. protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.
12009679|NCT00520169|Drug|intranasal ketamine|A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.
12009680|NCT00520156|Device|Continuous positive airway pressure (CPAP)|Patients diagnosed with obstructive sleep apnea (OSA) will be offered standard of care treatment of CPAP (patients given oral appliances for OSA are excluded from our study). Note: our study is a survey-based and observational study following patients who are being evaluated for sleep disorders. Those patients diagnosed with OSA would be offered CPAP or possibly an oral appliance regardless of whether they are entered into our study or not.
12009681|NCT00520143|Biological|alglucosidase alfa (recombinant human acid alpha-glucosidase [rhGAA])|IV infusion: 20mg/kg qow
12009682|NCT00520130|Biological|Rituximab|Rituximab: 375 mg/m(2) intravenous (IV), day 1 for patients with cluster of differentiation 20 (CD20)-positive disease.
12009683|NCT00520130|Drug|Cyclosporine|Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if graft versus host disease (GVHD) does not develop.
12009684|NCT00520130|Drug|Allogenic stem cell transplant (ASCT)|Allogenic stem cell transplant
12009685|NCT00520130|Drug|Conditioning Chemotherapy|"Fludarabine:30 mg/m(2) per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3.
~Cyclophosphamide:1200 mg/m(2) per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m(2) per day IV infusion, Daily on days 6, -5,-4, and -3"
12009686|NCT00520130|Drug|TMS|Tacrolimus: starting day -3 before transplant, given initially at 0.02 mg/kg/day CIV. Continue IV and then switch to an equivalent oral dose (when patient taking po) titrated for a goal level of 5 to 10 ng/ml; Sirolimus: given as an initial loading dose of 12 mg p.o. on day -3 pre-transplant, 4 mg starting day -2 pre-transplant and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post-transplant. Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-transplant as tolerated.
12009687|NCT00520130|Drug|FLAG|Fludarabine:25 mg/m(2) per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m(2) IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day subcutaneous (SC) beginning 24 hours PRIOR to initiation of chemotherapy
12009688|NCT00520130|Drug|EPOCH-F|Fludarabine:25 mg/m(2) per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m(2) per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m(2)/day CIV, days 1-4 Vincristine:0.4 mg/m(2) per day continuous IV infusion over 24 hours daily on days 1-4 Cyclophosphamide:750 mg/m(2) IV infusion over 30 minutes on day 5
12009689|NCT00520130|Biological|Alemtuzumab|Alemtuzumab:20 mg/day IV over 8 h on days 8 to 4 pre-transplant.
12009690|NCT00520104|Drug|intranasal ketamine|drug interaction
12009691|NCT00520091|Drug|CPT- 11|65mg/m2 given on days 1, 8 ,22 and 29 prior to surgery
12009692|NCT00520091|Drug|Cisplatin|Cisplatin 30mg/m2 will be administered on days 1, 8, 22 and 29 prior to surgery
12009693|NCT00520091|Drug|Celecoxib|400 mg, orally, twice per day beginning on day minus 3 and continue until the end of chemoradiation with CPT-11 and Cisplatin
12011129|NCT00509249|Other|pharmacological study|Correlative studies
12009696|NCT00520065|Other|enteral nutritional formula|Meal glucose tolerance test
12009697|NCT00520065|Other|Diabetes specific enteral product|Meal Glucose tolerance test
12009698|NCT00520052|Drug|zoledronic acid|5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)
12009699|NCT00520039|Procedure|osteopathic manipulative medicine (OMM)|At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
12009700|NCT00520026|Drug|lithium|
12009701|NCT00520026|Drug|placebo|
12009702|NCT00520013|Drug|bevacizumab|
12009703|NCT00520013|Drug|erlotinib|
12009704|NCT00520013|Drug|paclitaxel|
12009705|NCT00520013|Drug|carboplatin|
12009706|NCT00520000|Drug|Carboplatin|standard dose of area under the curve (AUC) AUC of 6 in all arms
12009707|NCT00520000|Drug|Abraxane|75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle
12009708|NCT00520000|Drug|Abraxane|180mg/m2 - 340mg/m2, repeated every 21 days
12009709|NCT00520000|Drug|Abraxane|100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle
12009710|NCT00519987|Drug|intranasal ketamine|intranasal ketamine
12009711|NCT00519974|Other|counseling intervention|
12009712|NCT00519974|Other|study of socioeconomic and demographic variables|
12009713|NCT00519974|Procedure|management of therapy complications|
12009714|NCT00519974|Procedure|psychosocial assessment and care|
12009715|NCT00519961|Device|Elecsys®proBNP|
12009716|NCT00519948|Drug|new MPS, opti-free express no rub MPS|
12009717|NCT00519935|Behavioral|Multisystemic Therapy|MST is an individualized approach that begins with a comprehensive, multi-informant assessment that allows for the development of treatment goals and interventions that are individually tailored for each family. Therapists draw upon a menu of evidenced-based interventions that include cognitive-behavioral therapy, parent training and behavioral family systems therapy.
12009718|NCT00519922|Other|Kinesthesia, Balance, and Agility (KBA) Exercise|"Participants will exercise three times per week 20 to 30 minutes per session. Agility/Active Range of Motion exercises provide warm-up, improve joint range-of-motion & agility, dynamic proprioception,functional strength & endurance.
~Kinesthesia & Balance Training will challenge the subject's proprioceptive and neuromuscular control mechanisms to adapt and stabilize the knee joints during dynamic ADL activities (walking, climbing, etc); improve static and dynamic balance and sense of stability & confidence in ADL activities.
~Soft pads will be used to progress some of the kinesthesia & balance challenge training. Thera-Band® balance pads at 3 levels of softness will be used. These balance pads allow both appropriate starting difficulty and progression of difficulty level (i.e., the softer the pad, the greater the difficulty). Subjects will demonstrate safe balance on a stable surface (i.e. one-footed standing on floor) prior to progressing to the first level of the soft pads."
12009719|NCT00519922|Other|Standard LE Strength Training|Standard therapeutic exercises for knee OA which are widely used. Body weight and Thera-Band® color coded elastic bands will be used as appropriate to provide resistance. Exercises will be progressed according to the individual participant's improvement. All training for the ST condition will be conducted on stable surfaces (e.g. standing on floor, sitting in chair, lying on floor). Exercises may include 4-direction straight leg lifts, heel slides, quad sets, internal & external hip rotation, heel raises, toe raises, knee extension, knee flexion, partial squats/wall slides, etc.
12009720|NCT00519909|Other|Dairy calcium|Diets with different content of calcium and fat
12009721|NCT00519896|Drug|sunitinib malate|Given PO
12009722|NCT00519883|Other|Exercise|
12009723|NCT00519883|Other|Supportive Care|
12009724|NCT00519870|Drug|nifedipine, losartan|I: nifedipine 30 mg/d II: losartan 50 mg/d
12009725|NCT00519870|Drug|losartan|II: losartan
12009726|NCT00519870|Drug|Nifedipine, losartan|I: nifedipine II: losartan
12009727|NCT00519857|Drug|Tibolone|1.25 mg p.o, once daily for 3 years
12009728|NCT00519857|Drug|Placebo|Tablet p.o, once daily for 3 years
12009729|NCT00519844|Drug|somatropin|
12009730|NCT00519831|Biological|cetuximab|400 mg/m² week 1,then 250 mg/m² weekly
12009731|NCT00519831|Drug|vinflunine|Vinflunine 320 mg/m² every 21 days
12009732|NCT00519818|Drug|Chronocort|Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration
12009733|NCT00519818|Drug|Cortef|Cortef 3 times daily(total dose 30 mg)for minimum of 7 days
12009734|NCT00519805|Drug|dalteparin|
12009735|NCT00519805|Procedure|quality-of-life assessment|
12009736|NCT00519792|Drug|Omega DUROS device|Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
12009737|NCT00519779|Dietary Supplement|omega-3 supplementation|2.5 g/day omega-3
12009738|NCT00519779|Dietary Supplement|Oral omega-3 fish oil placebo|to match experimental dosage
12009739|NCT00519753|Drug|Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)|One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks
12009740|NCT00519740|Other|inhalative specific bronchial provocation with grass-pollen|
12009741|NCT00519727|Drug|ISIS 325568|"4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg
~Placebo: 0.9% Sodium Chloride"
12009742|NCT00519714|Dietary Supplement|1-Methylnicotinamide (1-MNA)|Following a 6-8-week placebo and dietary-controlled baseline period, 195 men and women will be randomized to receive placebo, 30 mg MNA or 90 mg MNA three times daily for twelve weeks.
12009743|NCT00519714|Dietary Supplement|Placebo|Placebo
12009744|NCT00519701|Drug|hydroxyurea|
12009745|NCT00519688|Drug|Thalidomide|100 mg, BID
12009746|NCT00519688|Drug|Tegafur/Uracil|125 mg/m2, based on tegafur, BID
12009747|NCT00519675|Drug|alitretinoin|
12009748|NCT00519662|Drug|SNS-314|"Stage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15
~Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1"
12009749|NCT00519649|Biological|Engerix™-B Kinder|Intramuscular injection, 1 dose
12009750|NCT00519636|Drug|FPNS|fluticasone propionate nasal spray
12009751|NCT00519636|Drug|FFNS|fluticasone furoate nasal spray
12009752|NCT00519636|Drug|placebo FFNS|placebo nasal spray matching fluticasone furoate nasal spray
12009753|NCT00519636|Drug|placebo FPNS|placebo nasal spray matching fluticasone propionate nasal spray
12009754|NCT00519623|Other|PassPort(R) Transdermal Insulin Delivery System|The PassPort(R) Transdermal Insulin Delivery System is a drug-device combination product used to create micropores in the skin to enable transdermal delivery of insulin.
12009755|NCT00519610|Other|Chart Review|Patients' charts will be reviewed for relevant medical information.
12009756|NCT00519597|Device|ResMed S8 (Auto-CPAP)|AutoCPAP during sleep
12009757|NCT00519584|Drug|Ropivacaine|30 ml 0.5%
12009758|NCT00519584|Drug|dex|8 mg (2 ml)
12009759|NCT00519584|Drug|Bupivacaine|30 ml 0.5%
12009760|NCT00519584|Drug|Saline|0.9% saline; systemic and local
12009761|NCT00519571|Device|ImplantLock device|dental implant
12009762|NCT00519558|Drug|somatropin|
12009763|NCT00519545|Behavioral|Prayer|Data collection on physiological biomarkers
12009764|NCT00519532|Drug|Rotigotine|"Rotigotine transdermal patches:
~10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
~Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h"
12009765|NCT00519519|Drug|Omeprazole|intravenous 80mg bolus followed by 8mg / hr for 3 days
12009766|NCT00519506|Other|ThromboView|Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism
12009767|NCT00519493|Procedure|Suture|One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
12009768|NCT00519493|Device|Clozex|One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.
12009769|NCT00519480|Drug|GSK189075|GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.
12009770|NCT00519480|Drug|Metformin|Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.
12009771|NCT00519480|Drug|Placebo|Placebo will be available as an oral tablets.
12009772|NCT00519467|Drug|Chlorproguanil-dapsone-artesunate (CDA)|
12009773|NCT00519454|Other|Peripheral lab draws|100ml blood for analysis, taken no more than 4 times in one year.
12009774|NCT00519441|Other|pH study|All patients will have 48 hour pH study
12009775|NCT00519428|Drug|escitalopram|10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted
12009776|NCT00519428|Drug|bupropion extra long (XL)|150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted
12009777|NCT00519428|Drug|escitalopram + bupropion|same dosing schedule as for monotherapy
12009778|NCT00519415|Other|Tongue plate|A functional appliance use for maxillary protraction.It has two adams clasp and two C clasp to retained the appliance and long palatal plate in the canine area which cages the tongue and transfer the force of the tongue during physiological activity to the upper arch. It has posterior bite plate and middle screw for maxillary expansion.It should be used all the time except meal time and brushing the teeth,the acrylic appliance makes specifically for the patient.
12009779|NCT00519415|Other|Facemask|An extraoral appliance use for treatment of maxillary deficiency in growing patients.It takes anchorage from chin and forehead, it has removable intraoral appliance with hooks for elastics that exerted a force of 300 gr.It should be used 14 hours a day.
12009780|NCT00519402|Other|tonsillar examination and questionnaire completion|
12009781|NCT00519389|Biological|H5N1 VLP Vaccine|Two doses - Day 0 & Day 28
12009782|NCT00519389|Biological|Placebo|Two doses - Day 0 & Day 28
12009783|NCT00519376|Drug|GW642444M|drug
12009784|NCT00519376|Drug|GW642444H|drug
12009785|NCT00519376|Drug|placebo|
12009786|NCT00519363|Drug|atorvastatin|atorvastatin 40mg, given orally daily for 3 months.
12009787|NCT00519350|Procedure|Blood collection|In arterial or venous lines already present, small amounts of blood will be collected at certain timepoints following operation
12009788|NCT00519337|Drug|Ascorbic acid|Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days
12009789|NCT00519337|Drug|Placebo|Placebo capsule, 4 capsules the night before surgery followed by 1 capsule B.I.D. for 4 postoperative days
12009790|NCT00519324|Drug|Everolimus|10 mg/day (2 tablets of 5 mg each)
12009791|NCT00519311|Behavioral|Health Intervention Package|CHAP and Ask Diary
12009792|NCT00519298|Drug|SAM-531|dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531
12009793|NCT00519298|Other|placebo|placebo
12009794|NCT00519298|Drug|Donepezil|dosage form: 5 mg encapsulated tablets one single dose of 5 mg.
12009795|NCT00519285|Drug|Aflibercept|"25 mg/ml solution
~6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle"
12009796|NCT00519285|Drug|Placebo (for aflibercept)|"Sterile aqueous buffered solution identical to aflibercept
~1-hour IV on Day 1 of each 3-Week cycle"
12009797|NCT00519285|Drug|Docetaxel|"Marketed formulation
~75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)"
12009798|NCT00519285|Drug|Prednisone or Prednisolone|"Marketed formulation
~5 mg twice daily PO from day 1 continuously"
12009799|NCT00519272|Behavioral|Questionnaire|Series of surveys to be completed at the time of diagnosis and within one month after completion of treatment, taking approximately 45 minutes each time.
12009800|NCT00519259|Drug|Lobeline|
12009801|NCT00519246|Drug|Saline|Saline 5 ml administrated intravenously
12009802|NCT00519246|Drug|Opioid|Butorphanol tartrate 1 mg i.v.
12009803|NCT00519246|Drug|Opioid|Butorphanol Tartrate 2 mg i.v.
12009804|NCT00519246|Drug|NSAID|Flurbiprofen Axetil 50 mg i.v.
12009805|NCT00519246|Drug|NSAID|Flurbiprofen Axetil 100 mg i.v.
12009806|NCT00519246|Drug|Opioid|Tramadol Hydrochloride 10 mg i.v.
12009807|NCT00519246|Drug|Opioid|Tramadol Hydrochloride 20 mg i.v.
12009808|NCT00519233|Drug|AGS-1C4D4|IV
12009809|NCT00519220|Other|Symptom questionnaire|Patients will answer questionnaires evaluating their symptoms of achalasia.
12009810|NCT00519207|Drug|Lidocaine|1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
12009811|NCT00519207|Drug|24% Sucrose Solution|2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
12009812|NCT00519194|Device|Epicor LP Cardiac Ablation System|Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
12009813|NCT00519194|Procedure|Surgical ablation of permanent AF|Concomitant AF ablation during mitral valve surgery
12009814|NCT00519181|Drug|Valproic Acid|Valproic acid by oral route (20mg/Kg/day) during one year.
12009815|NCT00519168|Procedure|Urine sample|Standard of care
12009816|NCT00519168|Device|Electrode sleep recorder|Standard of care
12009817|NCT00519168|Procedure|phlebotomy|Standard of care
12009818|NCT00519155|Drug|MD05 and open flap debridement|recombinant human GDF-5 coated onto ß-tricalcium phosphate
12009819|NCT00519155|Procedure|Open flap debridement|Open flap debridement alone
12009820|NCT00519142|Drug|placebo for mitiglinide|three times a day with meals
12009821|NCT00519142|Drug|mitiglinide|three times a day with meals
12009822|NCT00519142|Drug|mitiglinide|two times a day with meals
12009823|NCT00519129|Device|3D-imager|3D-imager vs fluoroscopy during coloscopy
12009824|NCT00519116|Drug|Rapamune® (Sirolimus)|
12009825|NCT00519116|Drug|Tacrolimus|
12009826|NCT00519116|Drug|Perioperative Corticosteroids|The corticosteroids use was left up to the investigators decision.
12009827|NCT00519103|Other|exercise|
12009828|NCT00519090|Drug|Imatinib|Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.
12009829|NCT00519090|Drug|Nilotinib (AMN107)|Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
12009830|NCT00519077|Drug|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
12009831|NCT00519064|Biological|Adjuvanted influenza vaccine|
12009832|NCT00519051|Other|monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)|Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization
12009833|NCT00519038|Other|Clinical Pathways|Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams
12009834|NCT00519038|Other|Usual Care|Usual care is the current practice actually performed in the hospital
12009835|NCT00519012|Drug|Sertraline to Paroxetine|For subjects enrolled in this arm, sertraline will be initiated at 25mg, increased to 50mg on day 3, and maintained until day 14. If subjects show an early response (i.e. a 20% improvement in the MADRS total score from baseline) at week 2, sertraline will be continued and titrated at 50 - 100mg based on clinical judgment. On the other hand, if subjects fail to show an early response at week 2, they will be randomly divided into two groups. In one group, sertraline will be continued and titrated at 50 - 100mg, whereas in the other group sertraline will be switched to paroxetine. In this switching group, paroxetine will be started at 10mg on days 15 and 16, increased to 20mg on day 17, and further increased to 40mg by a weekly 10mg increase, while sertraline will be dosed at 25mg on day 15 and terminated on day 16.
12009836|NCT00519012|Drug|Paroxetine to Sertraline|Paroxetine will be initiated at 10mg, increased to 20mg on day 3, and maintained until day 14. If subjects show an early response (i.e. a 20% improvement in the MADRS total score from baseline) at week 2, paroxetine will be continued and titrated at 20 - 40mg based on clinical judgment. On the other hand, if subjects fail to show an early response at week 2, they will be randomly divided into two groups. In one group, paroxetine will be continued and titrated at 20 - 40mg, whereas in the other group paroxetine will be switched to sertraline. In this switching group, sertraline will be started at 25mg on days 15 and 16, increased to 50mg on day 17, and further increased to 100mg by a weekly 25mg increase, while paroxetine will be dosed at 10mg on day 15 and terminated on day 16.
12009837|NCT00518986|Drug|armodafinil|200 mg/day
12009838|NCT00518986|Drug|placebo|placebo
12009839|NCT00518973|Drug|Quetiapine|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
12009840|NCT00518973|Drug|Placebo|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
12009841|NCT00518960|Drug|ProAlgaZyme|
12009842|NCT00518947|Drug|Lithium|Treatment with lithium carbonate was initiated at a dose of 900-1200 mg/day. Serum lithium levels were monitored twice weekly, and the dose was adjusted to attain target levels between 0.8 and 1.0 mmol/L by the end of week one, with subsequent levels as high as 1.4 mmol/L permitted if needed.
12009843|NCT00518947|Drug|verapamil|The initial dose of verapamil was 80 mg b.i.d., and this was raised by 80 mg/day every three days to a maximum of 480 mg/day, unless intolerable side effects were produced at a lower level, in which case the dose was maintained at the highest tolerated amount.
12009844|NCT00518947|Drug|verapamil plus lithium|
12011078|NCT00509587|Procedure|laboratory biomarker analysis|Correlative studies
12009845|NCT00518934|Other|Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell|
12009846|NCT00518921|Drug|Capadenoson (BAY 68-4986)|1mg Capadenoson, double dummy
12009847|NCT00518921|Drug|Capadenoson (BAY 68-4986)|2mg Capadenoson, double dummy
12009848|NCT00518921|Drug|Capadenoson (BAY 68-4986)|4mg Capadenoson, double dummy
12009849|NCT00518921|Drug|Placebo|Placebo, double dummy
12009850|NCT00518908|Drug|Sevoflurane|3.2 Vol % for postconditioning
12009851|NCT00518895|Drug|dacarbazine plus Genasense|Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
12009852|NCT00518895|Drug|dacarbazine plus placebo|Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will receive placebo (that is, locally available commercial 0.9% Sodium Chloride Injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
12009853|NCT00518882|Drug|liraglutide|1.8 mg once daily for s.c. (under the skin) injection.
12009854|NCT00518882|Drug|exenatide|10 mcg twice daily for s.c. (under the skin) injection.
12009855|NCT00518869|Drug|PG2|500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.
12009856|NCT00518856|Other|Neonatal resuscitation protocol|training in neonatal resuscitation and sepsis identification early treatment
12009857|NCT00518856|Other|Standard of care|continued with current standard of care for birth attendants
12009858|NCT00518843|Behavioral|FBT-BN|Mobilizing parents to curtail binge eating and purging
12009859|NCT00518843|Behavioral|SPT|Supportive the individual patient to explore factors that might underlie the eating disorder
12009860|NCT00518830|Other|multi-component intervention|The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
12009861|NCT00518830|Other|Usual care|included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
12009862|NCT00518804|Behavioral|Functional Behavioural Skills Group and Parent Training|
12009863|NCT00518791|Other|Multidisciplinary Care|A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).
12009864|NCT00518791|Other|Usual Care|No altered organisation of care
12009865|NCT00518765|Drug|Aliskiren|
12009866|NCT00518765|Drug|Aliskiren plus placebo|
12009867|NCT00518765|Drug|Aliskiren|
12009868|NCT00518765|Drug|Aliskiren plus placebo|
12009869|NCT00518752|Procedure|Standard Oral Care|Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
12009870|NCT00518752|Procedure|Comprehensive Oral Care|Patients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day
12009871|NCT00518739|Drug|MK2461|Patients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 & beyond).
12009872|NCT00518726|Biological|Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008|seasonal influenza vaccine 15ug
12009873|NCT00518713|Drug|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
12009874|NCT00518713|Drug|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
12009875|NCT00518713|Drug|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
12009876|NCT00518713|Drug|Placebo|tablets; orally; daily for 15-18 weeks
12009877|NCT00518700|Other|new MPS|
12009878|NCT00518700|Other|RepleniSH|
12009879|NCT00518687|Biological|V710|0.5-mL single injection of V710 (60 µg)
12009880|NCT00518687|Biological|Placebo|0.5-mL single injection of matching placebo
12009881|NCT00518674|Procedure|local infiltration analgesia|local wound infiltration with 30 ml ropivacaine 0.2 % (60 mg)
12009882|NCT00518648|Other|Multifactorial fall prevention program|Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
12009883|NCT00518648|Other|Usual care|Usual care
12009884|NCT00518635|Drug|Nutropin|Nutropin 0.1 mg/day self-administered once a day
12009885|NCT00518622|Drug|Comparator: MK7009|Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
12009886|NCT00518622|Drug|Comparator: Placebo|MK7009 Placebo
12009887|NCT00518596|Dietary Supplement|Probiotic supplementation (Lactobacillus plantarum)|GastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe.
12009888|NCT00518583|Drug|Pegylated Liposomal Doxorubicin (Doxil)|Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
12009889|NCT00518570|Drug|Levetiracetam|Levetiracetam was started at 250 mg qhs at the end of the first week of the follicular phase. Dose was gradually increased up to 1500 mg bid as tolerated or clinically effective. The treatment phase lasted 4 months.
12009984|NCT00517790|Drug|ABT-869 .25 mg/kg|Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
12011079|NCT00509561|Biological|cetuximab|
12009890|NCT00518557|Procedure|Transcatheter Arterial Chemoembolization|The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.
12009891|NCT00518544|Drug|administration of hydroxyehtyl starch|colloid is administered during operation according to blood loss.
12009892|NCT00518531|Drug|alendronate|Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1.
12009893|NCT00518531|Drug|denosumab|Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1.
12009894|NCT00518518|Drug|Staloral 300|Staloral 300
12009895|NCT00518518|Drug|placebo|placebo
12009896|NCT00518505|Other|Symptom questionnaire|This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.
12009897|NCT00518492|Procedure|Blood Sampling|Blood draws at 6 and 12 months following end of 6108A1-500 trial.
12009898|NCT00518479|Drug|Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD|
12009899|NCT00518479|Drug|Valsartan 160mg OD; Moxonidine 400mcg OD|
12009900|NCT00518466|Drug|topiramate|25 mg modified-release capsules
12009901|NCT00518466|Drug|phentermine|7.5 mg immediate-release capsules
12009902|NCT00518466|Drug|topiramate|100 and 25 mg immediate-release tablets
12009903|NCT00518466|Drug|phentermine|37.5 and 7.5 mg immediate-release tablets
12009904|NCT00518453|Biological|Surface antigen inactivated influenza vaccine|1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition
12009905|NCT00518427|Drug|Insulin Glargine|"Lantus (insulin glargine [rDNA origin] injection), individual dosing , subcutaneous injection, 100 IU/ml.
~Duration of treatment will be judge by the investigator. Last QoL assessed in the study will be 9 months after start of glargine treatment."
12009906|NCT00518414|Other|Marketed infant formula with DHA and ARA|
12009907|NCT00518414|Other|Milk-based infant formula with DHA and ARA|
12009908|NCT00518414|Other|Milk-based formula with DHA, ARA, prebiotics|
12009909|NCT00518401|Biological|Mesendo|Intramuscular injection of 0.5 cc per site of the combination stem cell mixture in approximately 40 different ischemic sites of the gastrocnemius area of the calf.
12009910|NCT00518388|Behavioral|Focus Group|Focus groups each lasting about 2 hours.
12009911|NCT00518388|Behavioral|Questionnaire|Questionnaire relating to your health practices and knowledge about cervical cancer and HPV.
12009912|NCT00518375|Drug|Rapamune® (Sirolimus)|
12009913|NCT00518375|Drug|Neoral® (Cyclosporine)|
12009914|NCT00518375|Drug|Corticosteroids|Left up to local practice but steroids are typically used perioperatively
12009915|NCT00518362|Drug|TW|TW,120 mg/d
12009916|NCT00518349|Device|Passive bending function|Colonoscope with a passive bending function
12009917|NCT00518349|Device|No passive bending function|Examination using standard colonoscope without passive bending function
12009918|NCT00518336|Procedure|Blood sampling|Blood sampling at Visit 3, 5 and 7.
12009919|NCT00518336|Procedure|Collection of cervical specimen|Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.
12009920|NCT00518336|Biological|Cervarix|Three doses administered intramuscularly at 0, 1 and 6 months.
12009921|NCT00518323|Drug|Paliperidone ER|3 mg or 6 mg tablet once daily for 6 weeks
12009922|NCT00518323|Drug|Placebo|Once daily for 6 weeks
12009923|NCT00518323|Drug|Paliperidone ER|1.5 mg tablet once daily for 6 weeks
12009924|NCT00518323|Drug|Paliperidone ER|6 mg or 12 mg tablet once daily for 6 weeks
12009925|NCT00518310|Drug|Placebo|
12009926|NCT00518310|Drug|AZAPRED|The initial dose of prednisone will be 0.5 mg/kg/day for 4 weeks, then 0.25 mg/kg/day for 8 weeks. The dose will continue to decrease at a rate of 5 to 10 mg per week, to a dose of 0.25 or 0.125 mg/kg/day. Azathioprine will be given at a dose of 2-3 mg/kg/day (max 100 mg).
12009927|NCT00518297|Drug|Raltegravir|Tablet, Oral, 400 mg, twice daily for 5 Days
12009928|NCT00518297|Drug|Atazanavir|Capsule, Oral, 300 mg, twice daily for 7 Days
12009929|NCT00518297|Drug|Atazanavir + Raltegravir|Capsule/Tablet, Oral, 300/400, twice daily for 14 Days
12009930|NCT00518284|Drug|Nanoparticle Paclitaxel|Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
12009931|NCT00518271|Drug|Rapamune® (Sirolimus)|
12009932|NCT00518271|Drug|Tacrolimus|
12009933|NCT00518271|Drug|Corticosteroids|Perioperative
12009934|NCT00518245|Drug|enoxaparin|Enoxaparin will be given subcutanteously at a dose of 1mg/kg every 12 hours for a minimum of 48 hours (4 doses) and a maximum of 8 days until a diagnostic / therapeutic procedure is performed, or at the discretion of the investigator.
12009935|NCT00518232|Drug|OROS-methylphenidate|
12009936|NCT00518219|Drug|TW|TW,120mg/d
12009937|NCT00518206|Biological|NY-ESO-1 ISCOMATRIX® vaccine|NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
12009938|NCT00518206|Drug|Cyclophosphamide|Cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
12009939|NCT00518193|Drug|ERBITUX|400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks
12009940|NCT00518180|Biological|Novartis Meningococcal ACWY Conjugate Vaccine|One dose of vaccine administered intramuscularly
12009941|NCT00518180|Biological|Tdap Vaccine|One dose of vaccine administered intramuscularly
12009942|NCT00518180|Biological|Novartis Meningococcal ACWY Conjugate Vaccine|One dose of vaccine administered intramuscularly
12011080|NCT00509561|Drug|capecitabine|
12009943|NCT00518167|Behavioral|Intensive lifestyle counselling|"Individualized dietary and physical activity counselling aiming at
~weight reduction
~dietary fibre 15 g /1000 kcal or more
~energy proportion of dietary fat less than 30%
~energy proportion of saturated fat less than 10%
~moderate physical activity >30 minutes per day or 4 hours per week"
12009944|NCT00518154|Drug|Pyridostigmine tablets|Patients will take 30mg tid PO for 12 weeks
12009945|NCT00518141|Drug|Acetyl Salicylic Acid and Terbutalin|ASA 75 mg, Terbutalin 5mg
12009946|NCT00518128|Procedure|Surgical OSA treatment|uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension
12009947|NCT00518128|Procedure|Positive Airway Pressure Therapy|Continuous positive airway pressure for treatment of obstructive sleep apnea
12009948|NCT00518115|Drug|Albiglutide (GSK716155) or exenatide|Albiglutide weekly subcutaneous injection or exenatide twice daily injection
12009949|NCT00518102|Drug|REGRANEX (becaplermin)|A cohort of REGRANEX (becaplermin) users (ie, patients treated with REGRANEX (becaplermin), a topical medication used to treat non-healing neuropathic foot ulcers in patients with diabetes).
12009950|NCT00518102|Other|REGRANEX (becaplermin) comparators|A cohort of REGRANEX (becaplermin) nonusers (ie, patients who are not treated with REGRANEX [becaplermin]) but are similar in characteristics to patients in the REGRANEX [becaplermin] user cohort)
12009951|NCT00518089|Drug|Gatifloxacin 0.5% eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
12009952|NCT00518089|Drug|placebo eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
12009953|NCT00518050|Behavioral|Focus group|"Conduct focus groups in melanoma survivors to enhance the understanding of the behavioral aspects of:
~Screening, skin self-examination, sun protection, and other cancer preventive practices;
~Cognitive factors (knowledge, awareness, melanoma worry, and perceived risk) related to screening and sun protection practices; and,
~Impact of melanoma on quality of life, family relationships, and economic issues arising from treatment"
12009954|NCT00518050|Behavioral|Survey|History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors
12009955|NCT00518037|Behavioral|surveys|anxiety surveys
12009956|NCT00518024|Procedure|Repetitive Transcranial Magnetic Stimulation (rTMS)|Bilateral Theta Burst Stimulation
12009957|NCT00518011|Drug|Erlotinib|150 mg po daily
12009958|NCT00518011|Drug|Gemcitabine|As prescribed
12009959|NCT00517998|Drug|Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel|10 mL Hydrogel
12009960|NCT00517985|Drug|Duloxetine|During the current study, for a short period of time participants will receive a placebo (a pill that looks like the study drug but which does not contain any medication), although during the majority of the study, participants will be receiving the actual study medication (Duloxetine). The initial dose of Duloxetine to be given will be a 30 mg dose with the dosage increased over time to 60 mg per day. This study will be blinded, meaning that participants will not know whether they are taking placebo or the study drug. However, all subjects will receive duloxetine for the majority of the time they are enrolled in the trial. Investigators will know when subjects are receiving the placebo but in order to maintain the blinding of this study, the study staff will not be able to tell participants when they are taking placebo and when they are taking Duloxetine.
12009961|NCT00517972|Drug|Omacor (omega-3-acid ethyl esters)|
12009962|NCT00517959|Radiation|Stereotactic Conformal radiotherapy|SCRT
12009963|NCT00517959|Radiation|Conventional radiotherapy|
12009964|NCT00517946|Drug|pseudoephedrine hydrochloride|
12009965|NCT00517946|Drug|cetirizine hydrochloride|
12009966|NCT00517933|Drug|Sildenafil Citrate|Sildenafil citrate (20mg 3 times a day [TID] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)
12009967|NCT00517933|Other|Placebo|Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)
12009968|NCT00517920|Drug|ABT-869|0.25 mg/kg QD
12009969|NCT00517907|Drug|Preimplantation factor (PIF-1)|"The study will include 6 patients and will last for at least six months. The first three patients will receive PIF-1 (0.5 mg/kg/day for 14 days) by subcutaneous injection. The dosage in the next three patients may be increased to 1 mg/kg/day for 14 days.
~Patients will be treated serially: each patient will be followed for 2 weeks after cessation of PIF-1 administration before the next patient begins PIF-1 administration."
12009970|NCT00517894|Drug|CEOP/IMVP-Dexa chemotherapy|Cyclophosphamide 750 mg/m2 i.v. d 1, epirubicin 70 mg/m2 i.v d 1, vincristine 1.4 mg/m2 i.v. d 1+8, prednisolone 100 mg p.o. d 1-5, ifosfamide 2000 mg/m2 i.v. d 15-17, etoposide 100 mg/m2 i.v. d 15-17, dexamethasone 40 mg p.o. or i.v. d 15-19, methotrexate 800 mg/m2 i.v. d 22. Mesna was given with ifosfamide, calcium-folinate rescue after methotrexate. Filgrastim was given on days 2-7, 9-12, 18-21, 23-28
12009971|NCT00517881|Drug|Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)|Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.
12009972|NCT00517868|Drug|URG101|Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.
12009973|NCT00517868|Drug|Placebo|Liquid formulation without active URG101 drug components
12009974|NCT00517855|Biological|PRTX-100 (Staphylococcal protein A)|
12009975|NCT00517842|Drug|ViNeuro|
12009976|NCT00517829|Drug|Docetaxel|Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
12009977|NCT00517829|Drug|cetuximab|ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
12009978|NCT00517829|Drug|oxaliplatin|Eloxatin 130 mg/m2 IV over 2 hours
12009979|NCT00517816|Drug|RG1671|Administered iv at escalating doses (with a starting dose of 0.0015mg)
12009980|NCT00517803|Dietary Supplement|Probiotic Yogurt B: with various micronutrients|175g probiotic yogurt / day 25% RDA for each nutrient
12009981|NCT00517803|Dietary Supplement|Probiotic Yogurt A: Kaiser micronutrients|175g probiotic yogurt/ day 25% RDA for each nutrient
12009982|NCT00517803|Dietary Supplement|Probiotic yogurt C: with basic micronutrients|175g yogurt/ day 25% RDA for each nutrient
12009983|NCT00517803|Dietary Supplement|Probiotic Yogurt D: Placebo -- no added micronutrients|175g/day probiotic yogurt
12011081|NCT00509561|Drug|cisplatin|
12009985|NCT00517790|Drug|ABT-869 0.10 mg/kg|Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
12009986|NCT00517777|Device|continuous positive airway pressure ventilation|nighttime
12009987|NCT00517777|Behavioral|dietary and life style recommendations|
12009988|NCT00517777|Behavioral|dietary and life style recommendations|
12009989|NCT00517764|Drug|escitalopram|Patients started on 20mg of escitalopram and this dose was increased based on tolerability and therapeutic response to a maximum dose of 40mg by week 12. The trial was 16 weeks. The treatment trial has completed and is no longer accepting patients.
12009990|NCT00517751|Device|X-STOP PEEK|Placement of X-STOP PEEK in up to two levels in the lumbar spine for patients diagnosed with moderately symptomatic lumbar spinal stenosis in accordance with current labeling instructions for use.
12009991|NCT00517738|Other|Physical training|A program of exercising under strict surveillance, with endurance and coordination maneuvers
12009992|NCT00517738|Other|Diet intervention|Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
12009993|NCT00517725|Drug|carvedilol|
12009994|NCT00517725|Drug|bisoprolol|
12009995|NCT00517725|Drug|Nebivolol|
12009996|NCT00517712|Drug|Single agent arsenic trioxide|duration of maintenance therapy, 6 months versus 12 months
12009997|NCT00517699|Drug|rituximab [MabThera/Rituxan]|750mg/m2 iv
12009998|NCT00517699|Drug|Methotrexate|8g/m2 iv
12009999|NCT00517699|Drug|Cytarabine|2g/m2 iv
12010000|NCT00517686|Other|Information feedback intervention|This study will evaluate an information feedback intervention: measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD).
12010001|NCT00517673|Drug|GSK945237|
12010002|NCT00517673|Drug|Sugar Pill|Placebo
12010003|NCT00517647|Drug|ATMX|Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.
12010004|NCT00517634|Drug|FP|Fluticasone Propionate 100 mcg BD
12010005|NCT00517634|Drug|SFC|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
12010006|NCT00517634|Drug|Placebo|Matching Placebo
12010007|NCT00517621|Drug|Paclitaxel|
12010008|NCT00517621|Drug|EPO|
12010009|NCT00517608|Device|Laparoscopic colectomy|
12010010|NCT00517595|Drug|Pemetrexed and Gemcitabine plus Bevacizumab|Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m^2 and gemcitabine 1500 mg/m^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.
12010011|NCT00517582|Drug|HOE-140|Subcutaneous at time 0 and 6 hours
12010012|NCT00517582|Other|Placebo|Subcutaneous at time 0 and 6 hours
12010013|NCT00517569|Genetic|GX-12|a mixed plasma DNA (HIV-1 antigen genes and human IL-12 mutant) 4, 8, 16mg, i.m., once every other weeks for 22 weeks (total 12 times)
12010014|NCT00517569|Drug|HAART|Highly active antiretroviral therapy; Discontinuation at 24 weeks; NB: The patients should be treated with 2 NRTIs+1 NNRTI or 2 NRTIs + 1 PI, according to the guidelines published by DHHS in the USA.
12010015|NCT00517556|Drug|CCOCP|(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
12010016|NCT00517556|Drug|Traditional OCP|(traditional OCP) (21 active days/7 inactive days) treatment regimen
12010017|NCT00517543|Drug|GW856553|
12010018|NCT00517530|Drug|Obinutuzumab|Obinutuzumab was provided in single-dose glass vials as a freeze-dried powder.
12010019|NCT00517517|Biological|Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation|Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.
12010020|NCT00517504|Drug|Methylphenidate|"1-week single blind placebo lead-in phase.
~step-wise single blind titration of MPH at 1.25 mg bid for the first week, 2.5 mg bid for the second week , 5 mg bid for the third week, 7.5 mg bid for the fourth week and 10 mg bid for the 5th week.
~Dose increased if room for improvement in child's symptoms and no clinically important side effects. Dose not increased if no room for improvement in child's symptoms or if clinically important side effects.
~After single blind titration, child enters a 4-week double-blind randomized crossover study with placebo and child's best dose that produced maximal effect with minimal side effects, with each child serving as his/her own control."
12010021|NCT00517491|Drug|lanreotide (Autogel formulation)|120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.
12010022|NCT00517478|Procedure|Blood Sample|
12010023|NCT00517465|Drug|Placebo|po bid
12010024|NCT00517465|Drug|RG1511|Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
12010025|NCT00517439|Drug|Copegus|1000/1200mg po daily for 24 weeks
12010026|NCT00517439|Drug|Pegasys|180 micrograms sc weekly for 24 weeks
12010027|NCT00517439|Drug|Pegasys|90 micrograms sc weekly for 24 weeks
12010028|NCT00517439|Drug|RO4588161|1000mg po bid for 24 weeks
12010029|NCT00517439|Drug|RO4588161|500mg po bid for 24 weeks
12010030|NCT00517439|Drug|RO4588161|1500mg po bid for 24 weeks
12010031|NCT00517426|Drug|acetazolamide|i.v. 500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days
12010032|NCT00517413|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms sc or iv monthly, starting dose
12010033|NCT00517400|Device|Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham|
12010358|NCT00514891|Biological|Vitamin A|The effect of vitamin A given with different vaccines will be studied
12010034|NCT00517387|Drug|Quetiapine XR|All patients will receive Quetiapine XR at an initial dose of 50mg/day to be increased incrementally (dose of 50mg/day 2 and 150mg/day 3) to achieve a target dose of 300 mg/day by day 4. Tablets will be self-administered early each night.
12010035|NCT00517361|Drug|carboplatin|AUC 6 in 250mL saline IV over 30 minutes
12010036|NCT00517361|Drug|bevacizumab|15mg/kg in 100mL saline IV over 60 - 90 minutes
12010037|NCT00517348|Biological|IMA-026|SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV
12010038|NCT00517335|Procedure|Functional magnetic resonance imaging (fMRI) scan|Healthy control women, recovered bulimia women, and also recovered anorexia women will complete specific tasks in an fMRI scanner that will take up to 60 minutes.
12010039|NCT00517322|Drug|ramipril|ramipril 2.5- 5 mg once daily
12010040|NCT00517322|Drug|irbesartan|irbesartan 150-300 mg once daily
12010041|NCT00517309|Biological|V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years|
12010042|NCT00517309|Biological|Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years|
12010043|NCT00517296|Procedure|EUA with seton placement if necessary|Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.
12010044|NCT00517296|Drug|adalimumab|Patients began therapy with adalimumab using clinic standards for dosing.
12010045|NCT00517296|Procedure|EUS|Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.
12010046|NCT00517283|Drug|exenatide and placebo|Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. Period 3 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.
12010047|NCT00517283|Drug|Exenatide and placebo|Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. Period 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.
12010048|NCT00517283|Drug|Exenatide and placebo|Period 1 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.
12010049|NCT00517270|Drug|Rabeprazole 20mg twice daily|
12010050|NCT00517257|Drug|Atorvastatin|80 mg orally once daily for 24 weeks
12010051|NCT00517257|Drug|Placebo|Placebo tablet orally once daily for 24 weeks
12010052|NCT00517218|Drug|Genasense® (, oblimersen sodium G3139)|
12010053|NCT00517205|Procedure|Non-contrast helical computerized tomogram (NCHCT)|
12010054|NCT00517192|Drug|Tipranavir|
12010055|NCT00517192|Drug|Darunavir|
12010056|NCT00517192|Drug|Ritonavir|
12010057|NCT00517179|Drug|Vardenafil 10mg|
12010058|NCT00517166|Device|CAT (Combat Arms Tourniquet)|device
12010059|NCT00517153|Drug|miglustat|Patients aged 12 years or more randomised to the treatment group will receive 200 mg OGT 918 three times daily initially for twelve months. An additional sub-study of up to 12 patients aged under 12 years will receive a lower dose of OGT 918 according to their BSA
12010060|NCT00517140|Procedure|Repeat Caesaen section|
12010061|NCT00517140|Procedure|vaginal delivery|
12010062|NCT00517127|Drug|Lactated Ringer's Solution|Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.
12010063|NCT00517127|Drug|Hydroxyethylstarch 6% 130/0.4|Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.
12010064|NCT00517114|Drug|Rabeprazole 20mg twice daily|
12010065|NCT00517088|Drug|IPAQ|
12010066|NCT00517075|Device|Transcranial Magnetic Stimulation (TMS)|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
12010067|NCT00517075|Device|Transcranial Magnetic Stimulation (TMS)|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
12010068|NCT00517075|Device|Transcranial Magnetic Stimulation (TMS)|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
12010130|NCT00516620|Behavioral|Fruits (F), vegetables (V), and whole grain (WG) counseling|Participants receive Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
12010069|NCT00517075|Device|repetitive transcranial magnetic stimulation|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
12010070|NCT00517062|Drug|Growth hormone (Genotropin)|Growth hormone 0.1 mg self-injected once a day subcutaneously at bedtime.
12010071|NCT00517062|Drug|Placebo|Placebo self-injected once a day subcutaneously at bedtime.
12010072|NCT00517049|Drug|PRO95780|Intravenous repeating dose
12010073|NCT00517049|Drug|rituximab|Intravenous repeating dose
12010074|NCT00517036|Dietary Supplement|EPA omega-3 fatty acid|1 gram per day of an EPA-enriched mixture for 8 weeks
12010075|NCT00517036|Dietary Supplement|DHA omega-3 fatty acid|1 gram per day of pure DHA for 8 weeks
12010076|NCT00517036|Dietary Supplement|Placebo comparator|1 gram per day of an inactive substance for 8 weeks
12010077|NCT00517023|Device|Sleuth Implantable Loop Recorder|ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
12010078|NCT00517023|Other|Other|Routine care and tests usually offered for syncope patients.
12010079|NCT00517010|Drug|Proton beam irradiation and ranibizumab|ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
12010080|NCT00516984|Procedure|Placebo|No-touch control condition applied while subject was at a 50-degree head-up tilt.
12010081|NCT00516984|Procedure|Sham|Touch-only sham treatment applied while subject was at a 50-degree head-up tilt.
12010082|NCT00516984|Procedure|OMT|Cervical myofascial OMT applied while subject was at a 50-degree head-up tilt.
12010083|NCT00516971|Drug|Esomeprazole 20mg once daily|
12010084|NCT00516958|Drug|Topical Dermacyn|Topical Dermacyn once a day for 10 Days
12010085|NCT00516958|Drug|Topical Dermacyn and Levofloxacin|Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
12010086|NCT00516958|Drug|Topical Saline and Levofloxacin|Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
12010087|NCT00516945|Drug|Lamivudine|
12010088|NCT00516919|Drug|Xenical + behavioral intervention|120 mg TID; Behavioral weight loss in Spanish
12010089|NCT00516919|Behavioral|Behavioral intervention + placebo|Behavioral weight loss treatment in Spanish Placebo TID
12010090|NCT00516906|Drug|Chlorhexidine gluconate|2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
12010091|NCT00516906|Drug|Transparent Adhesive Dressing|Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
12010092|NCT00516893|Biological|BG00002-E (natalizumab high titer)|
12010093|NCT00516880|Drug|rosiglitazone|
12010094|NCT00516867|Radiation|UV radiation|UV radiation with 99.5% UVA and 0.5%UVB
12010095|NCT00516867|Radiation|UV radiation|UVB 1.4 % and UVA 98.6
12010096|NCT00516854|Drug|chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily|
12010097|NCT00516841|Drug|Volociximab|15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops
12010098|NCT00516828|Drug|cytarabine|subcutaneously twice daily from Day 1 to 10
12010099|NCT00516802|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12010100|NCT00516802|Drug|dacarbazine|intravenous injection over at least 20 minutes
12010101|NCT00516750|Drug|cisplatin|
12010102|NCT00516750|Drug|doxorubicin hydrochloride|
12010103|NCT00516750|Drug|methotrexate|
12010104|NCT00516750|Drug|vinblastine|
12010105|NCT00516750|Genetic|gene expression profiling|
12010106|NCT00516750|Procedure|neoadjuvant therapy|
12010107|NCT00516737|Drug|Comparator: rizatriptan benzoate|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
12010108|NCT00516737|Drug|Comparator: Placebo|Matching placebo; one dose, treatment of a single migraine attack
12010109|NCT00516724|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12010110|NCT00516724|Drug|Carboplatin|intravenous injection
12010111|NCT00516724|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|Oral
12010112|NCT00516724|Drug|Paclitaxel|Intravenous injection
12010113|NCT00516724|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|Oral
12010114|NCT00516724|Drug|Paclitaxel + Carboplatin|Intravenous injection
12010115|NCT00516711|Drug|Sevoflurane|
12010116|NCT00516698|Genetic|polymorphism analysis|
12010117|NCT00516698|Other|high performance liquid chromatography|
12010118|NCT00516698|Other|laboratory biomarker analysis|
12010119|NCT00516698|Procedure|radiomammography|
12010120|NCT00516685|Biological|Recombinant Human rEGF-P64K/Montanide Vaccine|
12010121|NCT00516672|Drug|pazopanib|Pazopanib oral tablet
12010122|NCT00516672|Drug|Lapatinib|Lapatinib oral tablet
12010123|NCT00516659|Biological|Heat-Labile Enterotoxin of Escherichia coli (LT)|Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
12010124|NCT00516659|Biological|Placebo|The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
12010125|NCT00516646|Drug|ALT-711|200 mg bid
12010126|NCT00516646|Drug|Placebo|bid
12010127|NCT00516633|Behavioral|Extra information and support|Four group discussions with parents in close connection to diagnosing the children
12010128|NCT00516620|Behavioral|No further instruction|Participants receive Health Canada's Food Guide and Physical Activity Guide and no other intervention for the 6 months of the intervention period.
12010129|NCT00516620|Behavioral|Food Delivery|Participants receive Canada's Food Guide and Physical Activity guide, in addition to a a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.
12010267|NCT00515476|Behavioral|physical exercise|8 weeks of regular exercise training
12010268|NCT00515463|Biological|denosumab|60 mg denosumab in 1mL
12010131|NCT00516620|Behavioral|Counseling to reduce soft drink intake.|Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
12010132|NCT00516620|Behavioral|Food Delivery & F, V & WG counseling.|Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
12010133|NCT00516620|Behavioral|Food delivery & soft drink counseling|Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
12010134|NCT00516620|Behavioral|F, V, WG & soft drink counseling|Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counseling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
12010135|NCT00516620|Behavioral|Food delivery and F,V, WG & soft drink counseling|Participants receive Health Canada's Food Guide and Physical Activity guide, receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
12010136|NCT00516607|Drug|enzastaurin hydrochloride|
12010137|NCT00516607|Drug|temozolomide|
12010138|NCT00516607|Other|pharmacological study|
12010139|NCT00516594|Procedure|Diet with polyfructans and viscous fibers or soy protein|
12010140|NCT00516542|Drug|letrozole|A daily dose of 2.5 mg will be used throughout the study.
12010141|NCT00516542|Drug|DHEA|Will be dispensed in either 500mg or 1000mg tablets. Subjects will start at a dose of 500 mg and may increase up to 5000mg depending on the cohort.
12010142|NCT00516542|Other|pharmacological study|PK draws will happen on day 1 and day 14, then every 2 weeks.
12010143|NCT00516516|Dietary Supplement|L-Carnitine|L-Carnitine, 1g orally, twice daily
12010144|NCT00516516|Dietary Supplement|Placebo|Placebo, similar in appearance to study tablets, given orally, twice daily.
12010145|NCT00516503|Drug|baclofen/amitriptyline/ketamine gel|Applied topically
12010146|NCT00516503|Other|placebo|Applied topically
12010147|NCT00516490|Drug|triptorelin acetate|Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
12010148|NCT00516490|Drug|Na Cl %0.9|0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer
12010149|NCT00516477|Biological|voretigene neparvovec-rzyl|Subjects will be dosed unilaterally (one eye) beginning with the lowest dose. Subjects will be injected with AAV2-hRPE65v2 by means of a subretinal injection. Dose escalation to the next cohort will be dependent on assessment of the safety data by the DSMB out to at least 4 weeks following the injection. Because there is a delay between time of delivery of AAV2 and the peak transgene expression there will be a delay of six weeks between all subjects.
12010150|NCT00516464|Drug|Lucentis (ranibizumab)|
12010151|NCT00516451|Drug|BMS-690514|Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more
12010152|NCT00516438|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12010153|NCT00516438|Drug|Topotecan|intravenous infusion
12010154|NCT00516425|Biological|pegfilgrastim|
12010155|NCT00516425|Drug|cyclophosphamide|
12010156|NCT00516425|Drug|doxorubicin hydrochloride|
12010157|NCT00516425|Drug|epirubicin hydrochloride|
12010158|NCT00516425|Genetic|proteomic profiling|
12010159|NCT00516425|Other|diagnostic laboratory biomarker analysis|
12010160|NCT00516425|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
12010161|NCT00516425|Other|pharmacological study|
12010162|NCT00516425|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
12010163|NCT00516425|Procedure|adjuvant therapy|
12010164|NCT00516412|Drug|everolimus|Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
12010165|NCT00516412|Genetic|molecular response by PCR|Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR. Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue
12010166|NCT00516399|Drug|povidone-iodine 1.25% ophthalmic solution|
12010167|NCT00516399|Drug|natamycin ophthalmic suspension, USP 5%|
12010168|NCT00516386|Drug|RhIGF-1|35-40 mcg/k/dose twice daily SC
12010169|NCT00516373|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12010170|NCT00516360|Device|3.15% chlorhexidine as daily antiseptic on needleless access port|3.15% chlorhexidine as daily antiseptic on needleless access port. 1 wipe used to cleanse port each time the port is accessed
12010171|NCT00516347|Genetic|comparative genomic hybridization|
12010172|NCT00516347|Genetic|genetic linkage analysis|
12010173|NCT00516347|Other|laboratory biomarker analysis|
12010174|NCT00516347|Other|questionnaire administration|
12010175|NCT00516347|Procedure|study of high risk factors|
12010176|NCT00516321|Drug|eltrombopag|25, 50, 75, 100 mg tablets taken once daily orally
12010177|NCT00516321|Drug|placebo|matched placebo taken once daily orally
12010178|NCT00516308|Device|NightHawk|
12010179|NCT00516295|Drug|topotecan hydrochloride|Given IV
12010180|NCT00516295|Drug|vincristine sulfate|Given IV
12010181|NCT00516295|Drug|cyclophosphamide|Given IV
12010182|NCT00516295|Biological|bevacizumab|Given IV
12010183|NCT00516282|Drug|CLORETAZINE|CLORETAZINE will be administered intravenously on day 7. The starting dose of CLORETAZINE will be 100 mg/m2 given within 3 hours after the last dose of Temodar on day 7. CLORETAZINE will be given as an IV infusion over 15-30 minutes via a freely flowing peripheral or central intravenous line. CLORETAZINE will be escalated by 50 mg/m2 for the second cohort then by 25 mg/m2 increments in the following cohorts of 3-6 patients using a standard phase I trial design until a MTD is determined. If dose level 2 has two DLTs then patients will be accrued to a new dose level of 125 mg/m2. Prior to receiving Cloretazine, blood will be drawn for gene methylation studies.
12010184|NCT00516282|Drug|temozolomide|Temozolomide will be given orally at a dose of 75mg/m2 daily on day 1 through 7. There will be no dose modification for this agent. Prior to receiving Temozolomide, blood will be drawn for gene methylation studies.
12010185|NCT00516269|Drug|Methylphenidate|18 mg by mouth daily for 2 weeks
12010186|NCT00516269|Drug|Placebo|Capsule by mouth daily for 2 weeks
12010187|NCT00516256|Behavioral|CHESS System|Internet-based computer program for 6 months.
12010188|NCT00516256|Behavioral|Cancer Information Mentor|Phone calls to the patient for 6 months.
12010189|NCT00516243|Other|placebo|Given PO
12010190|NCT00516243|Other|quality-of-life assessment|Ancillary studies
12010191|NCT00516243|Procedure|questionnaire administration|Ancillary studies
12010192|NCT00516243|Procedure|laboratory biomarker analysis|Correlative studies
12010193|NCT00516243|Drug|defined green tea catechin extract|Given PO
12010194|NCT00516217|Biological|galiximab|
12010195|NCT00516191|Drug|Liposomal Doxorubicin/Melphalan/Bortezomib|"Day 1 Bortezomib 0.7 mg/m(2)IV + Doxil 10-20 mg/m(2)IV+Melphalan 5-10mg/m(2)IV Day 4 Bortezomib 0.7 mg/m(2)IV Day 8 Bortezomib 0.7 mg/m(2)IV Day 11 Bortezomib 0.7 mg/m(2)IV
~The treatment cycles will be repeated every 28 days. Dose Level 1: Doxil 10mg/m(2), Melphalan 5 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 2: Doxil 10mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 3: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 4: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 1.0mg/m(2)"
12010196|NCT00516178|Drug|Fish oil emulsion|0.2 g/kg FO, 3 times in 24 hours, infused over 3 hours each in cardiac surgery, or continuous infusion of 0.6 g/kg post PTCA
12010197|NCT00516178|Drug|Saline|3 infusions, perioperative or post-PTCA
12010198|NCT00516165|Drug|RAD001|Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days
12010199|NCT00516152|Drug|Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF|"Day Preparative Regimen for GVHD Prophylaxis
~7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~3 Fludarabine 30 mg/m(2)IV
~2 REST Tacrolimus 0.01 mg/kg CIVI
~1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion
~1 Methotrexate 5mg/m(2)IV
~3 Methotrexate 5mg/m(2)IV
~6 Methotrexate 5mg/m(2)IV
~7 G-CSF 5mcg/kg SQ daily
~11 Methotrexate 5mg/m(2)IV
~90 Evaluate Response"
12010200|NCT00516139|Drug|Lamotrigine|Open-label
12010201|NCT00516113|Drug|paroxetine|Capsules containing either placebo or paroxetine 20 mg. The treatment start after ovulation and when the subject has experienced premenstrual irritability for 2 days. The dosage is one capsule daily at 8 AM
12010202|NCT00516100|Drug|bortezomib|MTD of bortezomib administered Days 1 and 8 plus 500 mg/m2 pemetrexed on day 1, every three weeks.
12010203|NCT00516087|Biological|Genetically modified CTLs|"LMP1- and LMP2-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
~Three different dosing schedules will be evaluated. Each patient will receive two injections, 14 days apart, according to the following dosing schedules:
~Group One Day 0 2x10^7 cells/m2 Day 14 2x10^7 cells/m2
~Group Two Day 0 2x10^7 cells/m2 Day 14 1x10^8 cells/m2
~Group Three Day 0 1x10^8 cells/m2 Day 14 2x10^8 cells/m2"
12010204|NCT00516074|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
12010205|NCT00516074|Drug|placebo|subcutaneous injection, volume equivalent to active, twice a day
12010206|NCT00516048|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
12010207|NCT00516035|Biological|Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)|Vaccine given by nasal spray
12010208|NCT00516022|Drug|Mistletoe extract|The drug will be administered 3 times a week at home.
12010209|NCT00516009|Drug|DEXAMETHASONE|
12010210|NCT00516009|Other|PLACEBO|
12010211|NCT00515983|Biological|DC/Apo-Nec|
12010212|NCT00515970|Procedure|Curettage|"Curettage without subcutaneous tissue using a 7 mm ring curette and the fountain-pen technique (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The curette is held between the thumb, index and middle finger. This method of holding enables precise guiding of the instrument, so that the piece of tissue can be removed in one well-targeted incision. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. Measurement of tumor thickness in mm."
12010213|NCT00515970|Procedure|Deep excision|12 o'clock mark. Excision with a scalpel down to the subcutaneous level. Plastic reconstruction. Three vertical, parallel bread loaf sections for histology. Preparation with paraffin. Staining with hematoxylin-eosin. Histologic diagnosis including report of tumor thickness in mm. Comment on complete removal (R0 versus R1). In case of R1 excision directed reoperations are performed until R0 is achieved.
12010214|NCT00515970|Procedure|Shave excision|Shave excision with a safety margin, using a scalpel. Wound healing by secondary intention. Preparation with paraffin. Parallel vertical bread loaf sections for histology. Staining with hematoxylin-eosin. Histologic diagnosis. Comment on complete removal (R0 versus R1). In case of R1 excision a reoperation is performed until R0 is achieved.
12010269|NCT00515463|Biological|denosumab|60 mg denosumab in 1mL
12010270|NCT00515450|Biological|GB-0998 (Intravenous immunoglobulin)|
12010271|NCT00515450|Procedure|Plasmapheresis|
12010272|NCT00515437|Biological|Botulinum Toxin Type B (Myobloc)|
12010273|NCT00515437|Biological|Matched placebo to Myobloc|
12010274|NCT00515424|Drug|RKI983|
12010359|NCT00514865|Drug|ONO-2333Ms|5-10 mg QD for 8 weeks
12010360|NCT00514865|Drug|ONO-2333Ms|0 mg QD for 8 weeks
12010215|NCT00515970|Procedure|Curettage|"Curettage with a 7 mm ring curette with the potato-peeler technique (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The handle of the curette is held in the distal inter-digital fold of the index finger, and supported by the other fingers of the curetting hand. The thumbs serve to provide a stable base. This technique makes it possible to guide the instrument, applying greater pressure, but accuracy is reduced. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining."
12010216|NCT00515957|Genetic|genetically modified CTLs in combo with CD45 antibodies|"LMP1- and LMP2- specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb).
~--Infusions of CD45 MAbs: A fixed dose of CD45 MAbs will be used determined from our previous and ongoing studies in stem cell transplant recipients will be used43, 400ug/kg over 6 to 8 hrs daily x 4 given as 4 daily intravenous infusions that will be completed 48-72 hours prior to CTL infusion.
~Day 1 YTH 24/54 400ug/kg over 6 to 8 hr 2 YTH 24/54 400ug/kg over 6 to 8 hr 3 YTH 24/54 400ug/kg over 6 to 8 hr 4 YTH 24/54 400ug/kg over 6 to 8 hr 5 Rest 6-8 CTL Infusion (provided CD45 MAb level <100 ng/ml)
~--LMP1- and LMP2-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
~2x 10^7 cells/m2
~1x 10^8 cells/m2 3 x 10^8 cells/m2
~1 x 10^9 cells/m2"
12010217|NCT00515944|Drug|Botulinum neurotoxin type A, free of complexing proteins|
12010218|NCT00515931|Radiation|Radiation therapy (external beam photons)|A cumulative radiation dose of 30 to 40 Gy is administered in 1.8 to 2.0 Gy fractions, 5 fractions per week, to the target lesion(s).
12010219|NCT00515918|Dietary Supplement|iron|
12010220|NCT00515905|Drug|Sevoflurane/propofol|Sevoflurane/propofol
12010221|NCT00515892|Drug|Immunotoxin therapy|
12010222|NCT00515892|Drug|CAT-8015 Immunotoxin|
12010223|NCT00515892|Procedure|Biological therapy|
12010224|NCT00515892|Procedure|Antibody Therapy|
12010225|NCT00515892|Procedure|Monoclonal Antibody Therapy|
12010226|NCT00515879|Drug|D-cycloserine|50 mg
12010227|NCT00515879|Behavioral|Cognitive behavioral therapy (CBT)|CBT sessions aim to help participants become more comfortable with social situations.
12010228|NCT00515879|Drug|Placebo|Same dosage as active pill
12010229|NCT00515866|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12010230|NCT00515866|Drug|Gemcitabine|intravenous injection
12010231|NCT00515853|Behavioral|Biofeedback|Biofeedback sessions or biofeedback exercises
12010232|NCT00515840|Other|Physiotherapist|Physiotherapist administered breathing retraining programme
12010233|NCT00515827|Drug|Raltegravir (MK-0518)|400 mg tablet taken orally twice daily
12010234|NCT00515827|Drug|Placebo|400 mg placebo tablet taken orally twice daily
12010235|NCT00515814|Device|Retina implant is surgically placed into subretinal position|Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility.
12010236|NCT00515801|Drug|glibenclamide|glibenclamide 15 mg single dose
12010237|NCT00515801|Drug|placebo|placebo capsules, single dose
12010238|NCT00515788|Drug|DepoCyt|Starting dose of 50 mg Intrathecal on Day 1 every 14 days for a total of 12 weeks (6 treatments). After the first 12 weeks, 50 mg Intrathecal on Day 1 every 28 days for 40 weeks (10 treatments).
12010239|NCT00515788|Drug|Temozolomide|100 mg/m^2 (capsules) by mouth daily for 7 consecutive days every 14 days.
12010240|NCT00515762|Device|elasto-gel cap|scalp cooling cap
12010241|NCT00515736|Drug|Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E|Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg
12010242|NCT00515736|Drug|Placebo|vehicle
12010243|NCT00515723|Drug|risperidone|randomized to 12 week trial of risperidone.
12010244|NCT00515723|Drug|olanzapine|randomized to 12 week trial of olanzapine.
12010245|NCT00515723|Drug|quetiapine|randomized to 12 week trial of quetiapine.
12010246|NCT00515723|Drug|ziprasidone|randomized to 12 week trial of ziprasidone.
12010247|NCT00515697|Biological|Ramucirumab|Ramucirumab is an injectable solution administered as an intravenous infusion over 1 hour at a dose of 8 mg/kg day 1 of every 14-day cycle.
12010248|NCT00515684|Drug|bevacizumab (Avastin)|
12010249|NCT00515671|Behavioral|Illness Management and Recovery|a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
12010250|NCT00515671|Behavioral|Problem Solving|Weekly problem-solving support group
12010251|NCT00515658|Device|theta-burst rTMS|
12010252|NCT00515645|Other|Head-down tilt and immersion|Head-down tilt -6° at inclusion, head-down tilt -15° at week one and Water Immersion at week two
12010253|NCT00515632|Drug|Balaglitazone|One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.
12010254|NCT00515619|Drug|Lacosamide|50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
12010255|NCT00515606|Drug|helium:oxygen|
12010256|NCT00515593|Drug|Parathyroid hormone (PTH) (Preotact)|Patients with severe postmenopausal osteoporosis
12010257|NCT00515580|Procedure|Tongue Sutures for Obstructive Sleep Apnea|Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.
12010258|NCT00515554|Drug|Rituximab|addition of Rituximab to BEACOPP escalated
12010259|NCT00515554|Drug|BEACOPP escalated|chemotherapy with BEACOPP escalated
12010260|NCT00515541|Drug|Lovaza|First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
12010261|NCT00515528|Drug|4-peptide melanoma vaccine|draft
12010262|NCT00515528|Drug|4-peptide melanoma vaccine plus Ontak|draft
12010263|NCT00515528|Drug|ontak|draft
12010264|NCT00515502|Drug|GSK573719|250 micrograms (μg) per blister, administered via dry powder inhaler, dose-ascending study doses began at 250 ug, then 500 ug, and 1000 μg
12010265|NCT00515502|Drug|Tiotropium|strips of five capsules, each containing 18 μg administered via dry powder inhaler
12010266|NCT00515489|Drug|Risperidone|as prescribed
12010275|NCT00515411|Drug|Docetaxel, Leucovorin, Fluorouracil, Cisplatin|Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
12010276|NCT00515411|Drug|Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen|"Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17
~* 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg
~Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter."
12010277|NCT00515411|Drug|Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab|"Treatment for Her2 Positive Participants
~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes."
12010278|NCT00515398|Other|Observation|Ex vivo administration of AT2220
12010279|NCT00515385|Drug|MGAWN1|"Eight subjects per cohort, each receives a single IV infusion of MGAWN1 of saline control on study day 0 (6 MGAWN1, 2 saline control.
~Cohort 1 - 0.3 mg/kg Cohort 2 - 1 mg/kg Cohort 3 - 3 mg/kg Cohort 4 - 10 mg/kg Cohort 5 - 30 mg/kg"
12010280|NCT00515385|Drug|MGAWN1|Single IV dose
12010281|NCT00515385|Other|Placebo|Single IV dose
12010282|NCT00515372|Other|Telephone Counseling|Weekly phone calls lasting about 30 minutes.
12010283|NCT00515372|Other|Usual Care|Lists of professional resources and referral recommendations will be provided.
12010284|NCT00515359|Procedure|Intermittent Propofol Sedation|Intermittent versus continuous dosage
12010285|NCT00515359|Procedure|Continuous Propofol Sedation|intermittent vs continuous dosage
12010286|NCT00515346|Device|Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia|
12010287|NCT00515333|Drug|TRx0014|Hard capsule; 60 milligrams; t.i.d.
12010288|NCT00515333|Drug|TRx0014|Hard capsule; 30 milligrams; t.i.d.
12010289|NCT00515333|Drug|Placebo|Hard capsule; 0 milligrams; t.i.d.
12010290|NCT00515333|Drug|TRx0014|Hard capsule, 100 milligrams, t.i.d.
12010291|NCT00515320|Drug|Fluoxetine|Once daily oral dispersible tablet 2mg 9mg or 18mg
12010292|NCT00515320|Drug|Placebo|Oral dispersible tablet placebo
12010293|NCT00515307|Procedure|Cellular transplantation|600 million to 1 billion cells will be infused through the portal vein over 30 minutes. Infusion will be done one time.
12010294|NCT00515294|Drug|Caffeinated Alcoholic Beer|Alcoholic Beer plus Caffeine Citrate powder.
12010295|NCT00515294|Other|Non-Caffeinated Alcoholic Beer|Alcoholic Non-Caffeinated Beer
12010296|NCT00515294|Drug|Caffeinated Non-Alcoholic Beer|Non-Alcoholic Beer plus Caffeine Citrate powder.
12010297|NCT00515294|Other|Non-Caffeinated, Non-Alcoholic Beer|Non-Alcoholic Beer
12010298|NCT00515281|Drug|inhaled nitric oxide|The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm.
12010299|NCT00515281|Drug|oxygen|The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation.
12010300|NCT00515268|Drug|GSK256066|GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.
12010301|NCT00515268|Drug|Placebo|Subjects will receive placebo inhaler.
12010302|NCT00515255|Drug|Minocycline|Capsules
12010303|NCT00515242|Behavioral|massage|therapeutic massage
12010304|NCT00515242|Behavioral|thermotherapy|heat therapy
12010305|NCT00515242|Behavioral|relaxing environment|time in a relaxing environment
12010306|NCT00515229|Drug|amitriptyline|"Each individual capsule has a filling volume of 25 mg, 50 mg und 75 mg Amitriptyline.
~Placebo: 25 mg corn starch"
12010307|NCT00515216|Drug|5-fluorouracil|
12010308|NCT00515216|Drug|Oxaliplatin|
12010309|NCT00515216|Drug|Leucovorin|
12010310|NCT00515203|Drug|Placebo|Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.
12010311|NCT00515203|Drug|AMG 531|Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.
12010312|NCT00515190|Drug|S-1,oxaliplatin|"Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal.
~Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles."
12010313|NCT00515177|Behavioral|Mindfulness-Based Stress Reduction|The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
12010314|NCT00515177|Drug|eszopiclone|"One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
12010315|NCT00515164|Drug|Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel|20 mL Hydrogel
12010316|NCT00515151|Drug|0.1% Octenidine with 30% 1-propanol and 45% 2-propanol|Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.
12010317|NCT00515151|Drug|74% Ethanol with 10% 2-propanol|Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.
12010357|NCT00514904|Biological|Mencevax|Single dose, subcutaneous injection
12010318|NCT00515138|Drug|Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib|Bortezomib starting at 1 mg/m(2), and escalating to 1.3, 1.5, 1.7. Bortezomib will be given on Days 1 (prior to rituximab) and 4, rituximab at 375 mg/m(2) on day 1, carboplatin AUC 5 and ifosfamide with mesna, each 5 mg/m(2), on day 3 and etoposide 100 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6
12010319|NCT00515125|Behavioral|Dietary Advice|Dietary Advice sheet
12010320|NCT00515125|Dietary Supplement|Oral Nutritional Supplements (Fortisip)|"These products are classified as non-medicinal, borderline substances, foods for special medical purposes.
~A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 12 week period."
12010321|NCT00515112|Drug|AndroGel|Androgel 1%, 10g daily
12010322|NCT00515112|Drug|placebo|placebo
12010323|NCT00515099|Drug|Antithymocyte globulin|Daily 4-day escalating dose
12010324|NCT00515099|Drug|Placebo|Daily 4-day saline solution
12010325|NCT00515086|Drug|Everolimus|Tablets taken once a day with a full glass of water.
12010326|NCT00515086|Procedure|Surgery|Salvage surgical resection
12010327|NCT00515073|Drug|Paclitaxel|50 mg/m^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.
12010328|NCT00515073|Radiation|Pelvic Radiation|Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.
12010329|NCT00515073|Drug|Dexamethasone|20 mg IV given 30 minutes prior to chemotherapy
12010330|NCT00515073|Drug|Cimetidine|300 mg IV given 30 minutes prior to chemotherapy
12010331|NCT00515073|Drug|Diphenhydramine|50 mg IV given 30 minutes prior to chemotherapy
12010332|NCT00515060|Other|Sensory Tests|Tests to find the threshold at which perceive stimuli.
12010333|NCT00515034|Drug|Imipenem/cilastatin|Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
12010334|NCT00515034|Drug|Imipenem/cilastatin|Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
12010335|NCT00515034|Drug|Doripenem|1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
12010336|NCT00515034|Drug|Doripenem|1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
12010337|NCT00515021|Drug|Eplerenone (Morning)|"Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg.
~100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks."
12010338|NCT00515021|Drug|Eplerenone (Night-time)|Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg
12010339|NCT00515008|Behavioral|Tai Chi Intervention|The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
12010340|NCT00515008|Behavioral|Control Intervention|Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
12010341|NCT00514995|Drug|Sodium Oxybate|4.5 g/night - 9 g/night, liquid taken twice per night
12010342|NCT00514982|Drug|Mesalamine|5-Aminosalicylic Acid Derivative used to treat mild to moderate Ulcerative Colitis
12010343|NCT00514982|Drug|Infliximab|Antirheumatic, Disease Modifying Gastrointestinal Agent, Miscellaneous, Monoclonal Antibody, Tumor Necrosis Factor (TNF) Blocking Agent used to treat gastrointestinal disorders.
12010344|NCT00514982|Drug|Corticosteroids|Systemic Corticosteroid used to treat inflammatory conditions.
12010345|NCT00514982|Drug|6-Mercaptopurine|Antineoplastic Agent, Antimetabolite, Immunosuppressant Agent used traditionally to treat Acute lymphoblastic leukemia. Unlabeled use as steroid-sparing agent for corticosteroid-dependent Crohn's disease (CD) and ulcerative colitis (UC); maintenance of remission in CD; fistulizing Crohn's disease.
12010346|NCT00514982|Drug|Tacrolimus|Immunosuppressant Agent used to treat Liver, Heart, Kidney transplant, prevent host vs graft disease, severe atopic dermatitis.
12010347|NCT00514982|Drug|Adalimumab|Antirheumatic, Monoclonal Antibody, Tumor Necrosis Factor (TNF) Blocking Agent used to treat Rheumatoid arthritis and Crohn's disease.
12010348|NCT00514969|Drug|Imatinib (STI571)|
12010349|NCT00514956|Behavioral|Emotional Freedom Techniques (EFT)|
12010350|NCT00514943|Drug|BIBW 2992|experimental drug taken once daily orally
12010351|NCT00514943|Drug|Cetuximab|active comparator administered weekly intravenously
12010352|NCT00514930|Device|Hexablate|
12010353|NCT00514917|Drug|Docetaxel|75 mg/m^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.
12010354|NCT00514917|Drug|Leuprolide|22.5 mg injection subcutaneously every 12 weeks up to 18 months.
12010355|NCT00514917|Drug|Bicalutamide|50 mg tablet orally once daily for first 4 weeks of treatment.
12010356|NCT00514904|Biological|Nimenrix|Single dose, intramuscular injection
12010362|NCT00514852|Drug|Carboxymethylcellulose and Glycerin based artificial tear|1 to 2 drops into each eye as needed but at least twice daily
12010363|NCT00514852|Drug|Carboxymethylcellulose|1 to 2 drops into each eye as needed but at least twice daily
12010364|NCT00514839|Behavioral|Motivational Interviewing|Two sessions of Motivational Interviewing (after baseline assessment and 4 weeks later) plus one individualized feedback based on the Transtheoretical Model of Behavior Change (8 weeks after baseline assessment)
12010365|NCT00514826|Other|altitude exposure|sojourn at moderate altitude (1860m and 2590m) during 2 days/nights each
12010366|NCT00514813|Drug|Dynepo|Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject
12010367|NCT00514800|Behavioral|Intervention - a validated home BP monitor and support from the specialist nurse|
12010368|NCT00514800|Behavioral|Control - usual care (BP monitoring by their practice)|"Patients will not receive a blood pressure monitor and will continue with usual GP care for hypertension management.
~GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings."
12010369|NCT00514774|Drug|ursodiol|"ursodiol 300 mg twice daily for study days 0 through 28
~ursodiol 600mg twice daily on study days 0 through 28"
12010370|NCT00514774|Drug|placebo|placebo 600mg twice daily for study days 0 through 28
12010371|NCT00514761|Drug|AZD6244|oral vial
12010372|NCT00514761|Drug|Capecitabine|oral tablet
12010373|NCT00514748|Procedure|DIEP|flap survival, operation time, flap complications, donor site morbidity.
12010374|NCT00514748|Procedure|Interconnected DIEP|flap survival, operation time, flap complications, donor site morbidity.
12010375|NCT00514735|Procedure|Medtronic Cardiac Ablation System|Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.
12010376|NCT00514735|Drug|Class I or III Antiarrhythmic Medications|Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.
12010377|NCT00514722|Other|umbilical cord stem cells|umbilical cord stem cell allogeneic transplantation
12010378|NCT00514709|Biological|DTaP-HB PRP~T Combined Vaccine|0.5 mL, Intramuscular (IM)
12010379|NCT00514709|Biological|DTaP-HB-PRP~T vaccine|0.5 mL, IM
12010380|NCT00514709|Biological|Oral Polio Vaccine|Oral co-administered with study vaccine.
12010381|NCT00514696|Drug|GCS-100|GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle
12010382|NCT00514683|Drug|low dose BIBF1120 once daily|low dose BIBF1120 once daily
12010383|NCT00514683|Drug|low dose BIBF 1120 twice daily|low dose BIBF 1120 twice daily
12010384|NCT00514683|Drug|intermediate dose BIBF 1120 twice daily|intermediate dose BIBF 1120 twice daily
12010385|NCT00514683|Drug|high dose BIBF 1120 twice daily|high dose BIBF 1120 twice daily
12010386|NCT00514683|Drug|placebo|placebo
12010387|NCT00514670|Other|Alcohol-based hand sanitizer & quaternary ammonium wipes|
12010388|NCT00514657|Drug|Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)|
12010389|NCT00514644|Other|Carotid ultrasound examination|Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
12010390|NCT00514644|Other|Panorama examination|"Examination with the odontological radiological method Panorama, including a frontal verification image"
12010391|NCT00514618|Drug|Misoprostol|patients will be treated with misoprostol 50 mcg PO q day for two days (days 1 and 4)
12010392|NCT00514618|Dietary Supplement|Placebo|patients will receive placebo (vitamin C) q day for two days (days 1 and 4)
12010393|NCT00514605|Other|Behavioral counseling|Standard-of-Care counseling at the Point-of-Care.
12010394|NCT00514605|Device|HIV-1 Antibody Test Kit|Assay to detect HIV antibodies
12010395|NCT00514592|Other|New Guidelines|New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
12010396|NCT00514579|Procedure|Cord blood transplantation|Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
12010397|NCT00514566|Device|Suture for midline abdominal closure|closure with Polyamide or Polydioxanone
12010398|NCT00514540|Drug|Docetaxel|75 mg/m^2 IV over 60 Minutes on Day 1 of 21 day cycle.
12010399|NCT00514540|Drug|Carboplatin|AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle.
12010400|NCT00514540|Drug|Etoposide|120 mg/m^2 daily for 3 days of 21 day cycle.
12010401|NCT00514540|Drug|Cisplatin|25 mg/m^2 for 3 days of 21 day cycle.
12010402|NCT00514527|Drug|oritavancin|Oritavancin as a single, infrequent or daily dose.
12010403|NCT00514514|Drug|Everolimus|Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen
12010404|NCT00514514|Drug|Myfortic|"1 tablet containing 180 mg or 360 mg
~Dosing schedule:
~Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day)"
12010405|NCT00514514|Drug|Sandimmun Optoral|1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level
12010406|NCT00514514|Drug|Simulect®|Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4
12010407|NCT00514501|Drug|Iodofiltic acid I 123|
12010408|NCT00514488|Drug|STI571 (400 mg/day; or 800 mg/day)|
12010409|NCT00514475|Drug|90Y-ibritumomab tiuxetan (Zevalin)|90Y-ibritumomab tiuxetan (Zevalin) at 0.4 mCi/kg is administered one week prior to start high-dose chemotherapy (BEAM/BEAC) in patients who have not achieved CR after induction therapy. Predosing with rituximab 250 mg/m2 one weeks prior to radioimmunotherapy and the same day.
12010410|NCT00514462|Device|diode laser|wavelength at 830nm, 9.7J/cm2 for 10 min
12010411|NCT00514449|Drug|Valacyclovir|1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic
12010412|NCT00514449|Drug|Placebo|2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic
12010413|NCT00514436|Behavioral|Asthma coaching|Inperson contact followed by telephone with approach by issues raised by family
12010414|NCT00514423|Other|Psychoeducation by professonals|
12010415|NCT00514423|Other|Psychoeducation by peer-moderators|
12010416|NCT00514423|Other|Video-education|
12010417|NCT00514423|Other|Noneducational video group (control group)|
12010418|NCT00514410|Drug|Folic Acid|Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment
12010419|NCT00514410|Drug|Placebo|Matching placebo taken once a day for three months
12010420|NCT00514397|Drug|motexafin gadolinium|
12010421|NCT00514397|Drug|temozolomide|
12010422|NCT00514397|Procedure|adjuvant therapy|
12010423|NCT00514397|Procedure|quality-of-life assessment|
12010424|NCT00514397|Radiation|radiation therapy|
12010425|NCT00514371|Drug|tanespimycin|High dose
12010426|NCT00514371|Drug|Bortezomib|Mid dose, and low dose
12010427|NCT00514345|Genetic|gene expression analysis|
12010428|NCT00514345|Genetic|polymorphism analysis|
12010429|NCT00514345|Procedure|management of therapy complications|
12010430|NCT00514332|Procedure|stent|stent placement for colorectal cancer obstruction
12010431|NCT00514306|Drug|OSI-906|Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
12010432|NCT00514293|Drug|bexarotene|
12010433|NCT00514293|Drug|capecitabine|
12010434|NCT00514293|Drug|carboplatin|
12010435|NCT00514293|Drug|cisplatin|
12010436|NCT00514293|Drug|docetaxel|
12010437|NCT00514293|Drug|tretinoin|
12010438|NCT00514267|Drug|YM 155|IV
12010439|NCT00514267|Drug|Docetaxel|IV
12010440|NCT00514267|Drug|Prednisone|Oral
12010441|NCT00514254|Other|questionnaire administration|
12010442|NCT00514254|Other|study of socioeconomic and demographic variables|
12010443|NCT00514254|Procedure|evaluation of cancer risk factors|
12010444|NCT00514241|Device|The GPS™ II Platelet Concentrate Separation Kit|The GPS™ II Platelet Concentrate Separation Kit system is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.
12010445|NCT00514228|Drug|sunitinib malate|"Starting dose: 37.5 mg 3 x 12.5 mg capsule
~Reduced dose: 25 mg 2 x 12.5 mg capsule"
12010446|NCT00514215|Biological|sargramostim|250 μg, inhaled, two times a day, on days 4-10 and days 36-42
12010447|NCT00514215|Other|flow cytometry|Days 1 & 32
12010448|NCT00514215|Other|immunoenzyme technique|Days 1 & 32
12010449|NCT00514215|Procedure|biopsy|CT guided biopsy on days 1 & 32
12010450|NCT00514215|Procedure|cryosurgery|Days 1 and 32
12010451|NCT00514202|Drug|Placebo|matched placebo
12010452|NCT00514202|Drug|Dextroamphetamine SR|60 mg/day
12010453|NCT00514189|Biological|Autologous Dendritic Cells|The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days).
12010454|NCT00514163|Drug|gemcitabine + S-1|gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks
12010455|NCT00514163|Drug|gemcitabine|gemcitabine DIV on day one , 8th and 15th
12010456|NCT00514150|Drug|Sodium Bicarbonate plus normal saline 0.9%|IV sodium bicarbonate 8.4% solved in 154 mEq/ L NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.
12010457|NCT00514150|Drug|normal saline 0.9%|IV 154 mEq/L solution of NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.)
12010458|NCT00514137|Drug|sunitinib malate|Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
12010459|NCT00514111|Drug|pegylated-interferon, conventional-interferon, ribavirin|Genotype 1: pegylated-interferon 2a or 2b plus ribavirin for 48 weeks. Genotype 3: conventional-interferon 2a or 2b plus ribavirin for 24 weeks.
12010460|NCT00514085|Biological|recombinant human interleukin-21|"Patients enrolled in Part A will receive treatment daily x 5 on weeks 1, 3, and 5 of an 8 week cycle.
~Patients enrolled in Part B will receive treatment daily x 5 on weeks 1, and 3 of a 6 week cycle"
12010461|NCT00514085|Other|immunohistochemistry staining method|Cycle 1 Day 1 and Cycle 1 Day 29
12010462|NCT00514085|Other|laboratory biomarker analysis|slides will be blocked for 15 minutes in 20% normal goat serum and then incubated in primary antibody
12010463|NCT00514085|Other|pharmacological study|Starting dose of 50μg/kg/day as an IV push
12010464|NCT00514072|Biological|BCG vaccine|given intradermally
12010465|NCT00514072|Biological|prostate cancer vaccine ONY-P1|given intradermally
12010466|NCT00514072|Other|placebo|given intradermally
12010467|NCT00514059|Drug|Boostrix polio|1 dose (0.5 ml) i.m.
12010468|NCT00514046|Drug|Vandetanib|once daily continuously (28 day cycles)
12010469|NCT00514033|Biological|Poliomyelitis vaccine (inactivated) -PoliorixTM|Deep intramuscular injections for the primary vaccination and booster vaccination.
12010470|NCT00514020|Drug|fluorouracil|Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
12010471|NCT00514020|Drug|leucovorin calcium|through a vein over 2 hours on days 1 and 15.
12010472|NCT00514020|Drug|oxaliplatin|500 ml D5W through a vein over 2 hours on days 1 and 15.
12010473|NCT00514020|Genetic|gene expression analysis|Blood collection
12010474|NCT00514020|Genetic|polymorphism analysis|Blood collection
12010475|NCT00514020|Genetic|protein expression analysis|Blood collection
12010476|NCT00514020|Other|pharmacological study|Blood collection
12010477|NCT00514007|Drug|OSI-906|OSI-906 administered orally
12010478|NCT00513994|Drug|Nitroglycerin|MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
12010479|NCT00513981|Drug|leucovorin calcium|
12010483|NCT00513968|Genetic|a mixed plasmid DNA (HB-110)|HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48.
12010484|NCT00513968|Drug|Adefovir|Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.
12010485|NCT00513955|Drug|bortezomib|
12010486|NCT00513955|Drug|cyclophosphamide|
12010487|NCT00513955|Drug|doxorubicin hydrochloride|
12010488|NCT00513955|Drug|prednisolone|
12010489|NCT00513955|Drug|vincristine sulfate|
12010490|NCT00513955|Other|questionnaire administration|
12010491|NCT00513955|Procedure|quality-of-life assessment|
12010492|NCT00513942|Other|Fetal Movement Counting|Women in the intervention group will receive an information pamphlet. The main items will be basic information and interpretation of fetal activity and instructions when to contact health professionals if experiencing DFM.
12010493|NCT00513929|Dietary Supplement|Zinc sulphate|Arm X : Zinc sulphate 10 mg will be given orally twice a day since admission to resolution of pneumonia episode in addition to standard antibiotic treatment.
12010494|NCT00513916|Dietary Supplement|soy isoflavones|High or low dose of soy isoflavones in the diet.
12010495|NCT00513903|Behavioral|Minimal intervention|Minimal intervention patients will be seen by a clinical pharmacist during the hospitalization period to improve continuity of pharmacy care following hospital discharge.
12010496|NCT00513903|Behavioral|Enhanced Intervention|Enhanced intervention patients will be visited in the hospital and will also be called by the clinical pharmacist following discharge to follow-up on any problems that might have developed after discharge.
12010497|NCT00513890|Device|Infantflow [EME, Brighton, England]|
12010498|NCT00513877|Drug|bortezomib|
12010499|NCT00513877|Procedure|quality-of-life assessment|
12010500|NCT00513864|Drug|Dextromethorphan|one time dose - 0.3mg/kg PO
12010501|NCT00513864|Drug|Codeine|one time dose - 2mg/kg PO
12010502|NCT00513864|Drug|Morphine|one time dose - 0.15mg/kg IV
12010503|NCT00513851|Drug|OSI-930|Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity
12010504|NCT00513851|Drug|OSI-930|Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity
12010505|NCT00513825|Drug|Sodium Bicarbonate|IV solution of NaCl 0.45% (Arm 1) or IV 75 cc of sodium bicarbonate 8.4% solved in 1 liter of NaCl 0.45% (Arm 2) . Each fluid is infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.
12010506|NCT00513799|Drug|Mupirocin ointment|Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
12010507|NCT00513799|Genetic|Chlorhexidine showers|Apply Clorhexidine wash to entire body once daily for 5 days.
12010508|NCT00513799|Procedure|Bleach baths (dilute)|Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
12010509|NCT00513799|Behavioral|Intensive education on personal hygiene|Repeat hygiene methods for 5 days.
12010510|NCT00513786|Drug|Carboplatin|AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
12010511|NCT00513786|Drug|Paclitaxel|175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
12010512|NCT00513786|Drug|bevacizumab|15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
12010513|NCT00513760|Dietary Supplement|Grapefruit juice|Coingestion of 240 ml of grapefruit juice with 10 mg of montelukast.
12010514|NCT00513760|Dietary Supplement|Orange Juice|Coingestion of 240 ml of orange juice with 10 mg of montelukast.
12010515|NCT00513760|Dietary Supplement|Gatorade|Coingestion of 240 ml of Gatorade with 10 mg of montelukast.
12010516|NCT00513747|Biological|rituximab|Given IV over 4 hours
12010517|NCT00513747|Drug|fludarabine phosphate|Given IV over 30 minutes
12010518|NCT00513734|Other|Hydrogel dressing|3x3cm hydrogel dressing over closed eye
12010519|NCT00513734|Other|Lacrilube ointment|lubricant put into eye (inferior formix)
12010520|NCT00513708|Behavioral|Motivation Enhancement Therapy (MET)|"Participants assigned to this arm will receive a 60-minute MET intervention in addition to usual care while hospitalized for detoxification."
12010521|NCT00513708|Behavioral|Peer-Twelve Step Facilitation (P-TSF)|"In addition to usual care while hospitalized for detoxification, participants assigned to this arm will receive a 60-minute visit by peers who are recovering from alcoholism and who are active in 12-step oriented self-help programs."
12010522|NCT00513695|Drug|sunitinib malate|Given PO
12010523|NCT00513695|Drug|paclitaxel|Given IV
12010524|NCT00513695|Drug|doxorubicin hydrochloride|Given IV
12010525|NCT00513695|Drug|cyclophosphamide|Given PO
12010526|NCT00513695|Biological|filgrastim|Given SC
12010527|NCT00513695|Procedure|therapeutic conventional surgery|Undergo surgery
12010528|NCT00513695|Other|laboratory biomarker analysis|Correlative studies
12010529|NCT00513695|Other|flow cytometry|Correlative studies
12010530|NCT00513682|Drug|Ultrase® MT20|Ultrase® MT20 capsules will be administered orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants will receive high-fat diet and Ultrase® MT20 dose will be adjusted depending on symptoms of steatorrhea. This will be followed by a washout phase of 6 to 7 days, in which participants will receive only high-fat diet; then stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) will be administered orally for 7 to 11 days during treatment phase. The stabilized dose should not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
12010531|NCT00513669|Biological|PEV 301& 302 in virosomes|PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90
12010532|NCT00513669|Biological|Inflexal V (active comparator)|Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90
12010533|NCT00513656|Drug|Oxycodone|
12010534|NCT00513656|Drug|Oxycodone/Naloxone|
12010535|NCT00513643|Drug|insulin aspart|6, 12, 24 U s.c.
12010536|NCT00513643|Drug|human regular insulin|6, 12 and 24 IU sc
12010537|NCT00513630|Drug|Glipizide|
12010539|NCT00513617|Drug|Arginine|Depending on the weight of the child or adult, the patients took any where between 4-10 capsules 2 times a day. Patients weighing less than 45 kilograms were on the low dose active (or placebo) so the capsules were smaller. Patients greater than or equal to 45 kgs were on the high dose active or placebo, so these capsules were larger.
12010540|NCT00513617|Drug|Placebo|Depending on the weight of the child or adult, the patients took any where between 4-10 capsules 2 times a day. Patients weighing less than 45 kilograms were on the low dose active (or placebo) so the capsules were smaller. Patients greater than or equal to 45 kgs were on the high dose active or placebo, so these capsules were larger.
12010541|NCT00513604|Biological|aldesleukin|Given subcutaneously every 8 hours for up to 15 doses, day 0, 720,000 IU/kg
12010542|NCT00513604|Biological|therapeutic autologous lymphocytes|Given as infusion, up to 3 x 10^11 lymphocytes (minimum of 1 x 10^9), day 0
12010543|NCT00513604|Drug|Cyclophosphamide|Given intravenously 60 mg/kg/day, day -7 to -6
12010544|NCT00513604|Drug|Fludarabine phosphate|Given intravenously 25 mg/m^2/day over 15-30 minutes, day -5 to -1
12010545|NCT00513604|Radiation|Total body irradiation|600 cGy
12010546|NCT00513578|Biological|PR1 leukemia peptide vaccine|
12010547|NCT00513578|Biological|incomplete Freund's adjuvant|
12010548|NCT00513578|Biological|sargramostim|
12010549|NCT00513565|Drug|single dose|Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
12010550|NCT00513552|Drug|Rifabutin, Clarithromycin, and Clofazimine|Rifabutin 150 mg by mouth twice daily, Clarithromycin 250 mg by mouth twice a day, and Clofazimine 100 mg by mouth each morning
12010551|NCT00513539|Drug|porfimer sodium|
12010552|NCT00513539|Procedure|biliary stenting|
12010553|NCT00513526|Biological|Gardasil|week 0, 8, 24, 128
12010554|NCT00513513|Drug|TMC114 (darunavir) / ritonavir|
12010555|NCT00513500|Drug|Coartem and amoxicillin|Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
12010556|NCT00513500|Drug|Coartem|Give Coartem without RDT and refer fast breathing
12010557|NCT00513487|Drug|Dust mite extract, Fluticasone, Methacholine|Dust mite extract, Fluticasone, Methacholine
12010558|NCT00513474|Drug|busulfan|Busulfan 3.2 mg/kg/day from day -7 to day -4 as standard of care for myeloablative (bone marrow depletion) conditioning at the investigator's discretion
12010559|NCT00513474|Drug|cyclophosphamide|Cyclophosphamide as standard of care for myeloablative conditioning at the investigator's discretion
12010560|NCT00513474|Drug|cyclosporin-A|Cyclosporin-A as standard of care for GVHD prophylaxis at the investigator's discretion
12010561|NCT00513474|Drug|etoposide|Etoposide as standard of care for myeloablative conditioning at the investigator's discretion
12010562|NCT00513474|Drug|methotrexate|Methotrexate 1.5 mg/kg/day on days -3, -2, and -1 as standard of care for GVHD prophylaxis at the investigator's discretion
12010563|NCT00513474|Drug|rasburicase|Rasburicase 0.20 mg/kg intravenous infusion over 30 minutes for 5 to 7 days
12010564|NCT00513474|Drug|sirolimus|Sirolimus as standard of care for GVHD prophylaxis at the investigator's discretion
12010565|NCT00513474|Drug|tacrolimus|Tacrolimus as standard of care for GVHD prophylaxis at the investigator's discretion
12010566|NCT00513474|Procedure|allogeneic hematopoietic stem cell transplantation|
12010567|NCT00513474|Procedure|peripheral blood stem cell transplantation|
12010568|NCT00513474|Radiation|total-body irradiation|Total body irradiation 13.2 Gy over 8 fractions from day -7 to day - 4 for myeloablative conditioning at the investigator's discretion
12010569|NCT00513474|Drug|fludarabine|Fludarabine 40 mg/m^2/day from day -6 to day -3 as myeloablative conditioning at the investigator's discretion
12010570|NCT00513474|Drug|allopurinol|Allopurinol per institutional guidelines
12010571|NCT00513461|Drug|S-adenosyl-L-methionine disulfate p-toluene-sulfonate|Given PO
12010572|NCT00513461|Other|placebo|Given PO
12010573|NCT00513461|Other|laboratory biomarker analysis|Correlative studies
12010574|NCT00513461|Other|immunoenzyme technique|Correlative studies
12010575|NCT00513461|Other|high performance liquid chromatography|Correlative studies
12010576|NCT00513448|Other|Group wellness intervention|
12010577|NCT00513448|Other|Individualized physical rehabilitation|
12010578|NCT00513435|Drug|saracatinib|Given PO
12010579|NCT00513435|Other|laboratory biomarker analysis|Correlative studies
12010580|NCT00513422|Dietary Supplement|Glucosamine sulphate and chondroitin|"Glucosamine: Two 750mg capsules once daily for two years;
~Chondroitin: Two 400mg capsules once daily for two years."
12010581|NCT00513422|Dietary Supplement|Glucosamine sulphate|"Glucosamine: Two 750mg capsules once daily for two years;
~Placebo Chondroitin: Two capsules once daily for two years."
12010582|NCT00513422|Dietary Supplement|Chondroitin sulphate|"Chondroitin sulphate: Two 400mg capsules once daily for two years;
~Placebo glucosamine: Two capsules once daily for two years."
12010583|NCT00513422|Dietary Supplement|Placebo capsules for glucosamine and chondroitin|"Two placebo glucosamine capsules once daily for two years;
~Two placebo chondroitin capsules once daily for two years."
12010584|NCT00513409|Biological|Synflorix|Intramuscular injection, 1 or 2 doses
12010585|NCT00513409|Biological|Infanrix Hexa|1 Intramuscular injection
12010586|NCT00513409|Biological|Havrix|1 Intramuscular injection
12010587|NCT00513396|Drug|Isoniazid|"High-dose isoniazid (16-18 mg/kg/day) in addition to standardized regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)
~Regular dose isoniazid (5 mg/kg/day) in addition to standard regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)"
12010588|NCT00513396|Drug|Placebo|Similar appearing and similarly packaged placebo tablets in addition to the standardized regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)
12010589|NCT00513383|Drug|Panitumumab|Part A: Intravenously once a week for 7 weeks Part B (Induction Chemotherapy): Intravenously on Day 1 of a 21-day cycle for 3 cycles Part B (After Induction chemotherapy): Intravenously once a week for 7 weeks at the dosing level established during Part A
12010590|NCT00513383|Drug|Carboplatin|Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks
12010591|NCT00513383|Drug|Paclitaxel|Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks
12010592|NCT00513383|Radiation|Intensity Modulated Radiation Therapy|Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks
12010593|NCT00513383|Drug|5-Fluorouracil|Intravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles
12010594|NCT00513383|Drug|Docetaxel|Intravenously on day 1 of a 21-day cycle for 3 cycles
12010595|NCT00513383|Drug|Cisplatin|Intravenously on day 1 of a 21-day cycle for 3 cycles
12010596|NCT00513370|Biological|Humira (adalimumab)|Study drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.
12010597|NCT00513357|Drug|Melatonin|20 mg by mouth daily for 4 Weeks
12010598|NCT00513357|Drug|Placebo|Capsule by mouth daily for 4 Weeks
12010599|NCT00513344|Dietary Supplement|Dark Chocolate|1 portion
12010600|NCT00513344|Dietary Supplement|Milk Chocolate|1 portion
12010601|NCT00513344|Dietary Supplement|"Control (polyphenol-free) Chocolate"|one portion
12010602|NCT00513331|Procedure|Endoscopy|Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
12010603|NCT00513331|Procedure|Radiofrequency ablation protocol|Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
12010604|NCT00513331|Procedure|Endoscopic mucosal resection protocol|Excision of lesion using DUETTE, marketed by Wilson-Cook
12010605|NCT00513305|Drug|Arsenic trioxide|Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.
12010606|NCT00513305|Drug|Low-dose cytarabine alone|Cytarabine will be administered at a dose of 10 mg/m^2 subcutaneously (sc) twice a day (bid).
12010607|NCT00513292|Drug|Cyclophosphamide|Given IV
12010608|NCT00513292|Drug|Epirubicin Hydrochloride|Given IV
12010609|NCT00513292|Other|Laboratory Biomarker Analysis|Correlative studies
12010610|NCT00513292|Drug|Paclitaxel|Given IV
12010611|NCT00513292|Procedure|Therapeutic Conventional Surgery|Undergo surgery
12010612|NCT00513292|Biological|Trastuzumab|Given IV
12010613|NCT00513279|Drug|GSK618334|GSK618334 will be available as white to off-white coated tablets. GSK618334 will be swallowed with 250 milliliters (mL) of water.
12010614|NCT00513279|Drug|GSK618334 matching placebo tablets|GSK618334 placebo tablets visually match the active GSK618334 tablets and contain the same excipients except for the omission of the active ingredient. GSK618334 matching placebo will be swallowed with 250 mL of water.
12010615|NCT00513266|Biological|bevacizumab|
12010616|NCT00513266|Biological|cetuximab|
12010617|NCT00513266|Drug|fluorouracil|
12010618|NCT00513266|Drug|irinotecan hydrochloride|
12010619|NCT00513266|Drug|leucovorin calcium|
12010620|NCT00513266|Drug|oxaliplatin|
12010621|NCT00513266|Other|laboratory biomarker analysis|
12010622|NCT00513266|Procedure|adjuvant therapy|
12010623|NCT00513266|Procedure|biopsy|
12010624|NCT00513266|Procedure|conventional surgery|
12010625|NCT00513266|Procedure|neoadjuvant therapy|
12010626|NCT00513253|Drug|lapatinib|
12010627|NCT00513240|Drug|Erythropoetin|Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2
12010628|NCT00513240|Drug|Normal saline|"Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.
~."
12010629|NCT00513214|Drug|XOMA 052|"Part 1, Single IV infusion at one of six dose levels (mg/kg).
~Part 2, Single SC injection at one of three dose levels (mg/kg).
~Part 3, Three biweekly SC injections at one of two dose levels (mg/kg)."
12010630|NCT00513214|Drug|Placebo|"Part 1, Single IV infusion at one of six dose levels (mg/kg).
~Part 2, Single SC injection at one of three dose levels (mg/kg).
~Part 3, Three biweekly SC injections at one of two dose levels (mg/kg)."
12010631|NCT00513201|Drug|lyspro|
12010632|NCT00513201|Drug|regular insulin|
12010633|NCT00513188|Biological|denileukin diftitox|
12010634|NCT00513188|Drug|cyclophosphamide|
12010635|NCT00513188|Drug|cytarabine|
12010636|NCT00513188|Drug|doxorubicin hydrochloride|
12010637|NCT00513188|Drug|leucovorin calcium|
12010638|NCT00513188|Drug|methotrexate|
12010639|NCT00513188|Drug|prednisone|
12010640|NCT00513188|Drug|vincristine sulfate|
12010641|NCT00513188|Genetic|protein expression analysis|
12010642|NCT00513188|Other|flow cytometry|
12010643|NCT00513188|Other|laboratory biomarker analysis|
12010644|NCT00513162|Drug|Valproate|Starting Dose of 10 mg/kg By Mouth Daily
12010645|NCT00513162|Drug|Etoposide|25 - 50 mg/m^2 By Mouth Daily
12010646|NCT00513149|Drug|Clopidogrel|Clopidogrel 600 mg loading
12010647|NCT00513136|Behavioral|Group based mind body medicine intervention|Small groups of women (5-15) will participate in 10 weekly sessions that will include learning relaxation and yoga techniques, principles of exercise and nutrition, cognitive behavioral therapy and exploration of common issues and concerns
12010648|NCT00513136|Behavioral|Group-based mind body medicine intervention + family focus|In addition to the 10 weekly group-based sessions, women and their key family members will meet twice with a cognitive therapist and family members will participate in selected aspects of the 10 week program.
12010649|NCT00513123|Procedure|Colposcopy|As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.
12010650|NCT00513110|Genetic|AMPD1 polymorphism|Endotoxin 2ng/kg to subjects with a AMPD1 polymorphism
12011082|NCT00509561|Radiation|radiation therapy|
12010651|NCT00513110|Drug|Caffeine infusion|Endotoxin 2ng/kg combined with caffeine. Caffeine (4mg/kg) is used as an adenosine receptor antagonist.
12010652|NCT00513110|Drug|placebo|Endotoxin 2ng/kg combined with saline infusion (0.9%)
12010653|NCT00513097|Behavioral|Smoking Prevention Program|Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.
12010654|NCT00513097|Behavioral|Focus Group|A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.
12010655|NCT00513097|Behavioral|Survey|On-line evaluations and questionnaires
12010656|NCT00513084|Behavioral|SDT and Motivational Interviewing in Obesity Treatment|Thirty group sessions, designed to follow SDT, covering PA, eating/nutrition, body image, and other cognitive-behavioral contents. Central to the intervention are improving autonomy, intrinsic motivation, and self-regulation of behavior change. Accepting ambivalence for change, rolling with resistance, and developing discrepancy were used throughout the program, with an emphasis on promoting intrinsic, self-regulated motivation for exercise and weight control.
12010657|NCT00513071|Drug|saracatinib|Given orally
12010658|NCT00513071|Other|laboratory biomarker analysis|Correlative studies
12010659|NCT00513058|Drug|Lapatinib|Dose level (DL) 1 : 750 mg/d DL2, DL3, DL4: 1000 mg/d DL5, DL7, DL8: 1250 mg/d DL6: 1500 mg/d
12010660|NCT00513058|Drug|vinorelbine|DL1, DL2: 20 mg/m2 DL3: 22.5 mg/m2 DL4, DL5, DL6: 25 mg/m2 DL7: 27.5 mg/m2 DL8: 30 mg/m2
12010661|NCT00513045|Behavioral|IRT|Cognitive behavior intervention
12010662|NCT00513045|Behavioral|Exposure|Exposure intervention
12010663|NCT00513032|Drug|methylene blue|5mg.kg-1 methylene blue in 250 ml 5% glucose-saline, administered intravenously approximately 60 min before anaesthesia induction
12010664|NCT00513019|Drug|Lamictal (lamotrigine)|once daily from beginning to end of study. Dosage varies.
12010665|NCT00513019|Drug|Placebo|daily
12010666|NCT00512993|Drug|Zoledronic acid|Infusion of zoledronic acid (4 mg) every 4 weeks for six doses, followed by every 3 months for 8 doses, followed by every 6 months for 5 doses
12010667|NCT00512980|Drug|prednisone|
12010668|NCT00512980|Drug|vinblastine|
12010669|NCT00512980|Drug|doxorubicin|
12010670|NCT00512980|Drug|gemcitabine|
12010671|NCT00512928|Drug|acenocoumarol|max 5 mg per day during 10 weeks
12010672|NCT00512928|Dietary Supplement|menaquinone-7|In successive weeks (6 weeks) the dosage is increased over the range 10 µg to 20 µg increasing to 45 µg MK-7 for the final week.
12010673|NCT00512915|Device|pacemaker implantation|St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer
12010674|NCT00512902|Drug|Imatinib|All subjects will receive gleevec. Subjects will have a clinic visit every 2 weeks for the first 20 weeks and then they will have one every 4 weeks for the remainder of the study. Gleevec will be taken by mouth everyday. It will be increased to a maximum of 600 mg every day. It will be increased 100 mg at each visit for the first 12 weeks. Your participation may last up to 1 year and participants will have approximately 18 clinic visits.
12010675|NCT00512902|Drug|Imatinib|Up to 600 mg QD PO for up to 1 year.
12010676|NCT00512889|Biological|therapeutic autologous lymphocytes|Autologous CTL generated from peripheral blood following culture with MART1/Melan-A peptide pulsed aAPC.
12010677|NCT00512889|Genetic|Use of an artificial antigen presenting cell (aAPC) to generate CTL|A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.
12010678|NCT00512889|Drug|GM-CSF|GM-CSF will be used as an immune activator and combined with the infusion of MART1/Melan-A specific CTL.
12010679|NCT00512889|Radiation|Irradiation of cutaneous tumor lesion|Irradiation of cutaneous melanoma lesion will be combined with the infusion of MART1/Melan-A specific CTL.
12010680|NCT00512876|Drug|Bevacizumab (Avastin)|Bevacizumab 10mg/mL 1 drop BID x 3 weeks
12010681|NCT00512863|Drug|Humira (adalimumab)|
12010682|NCT00512850|Dietary Supplement|Folic acid|Intervention group 1g folic acid per day
12010683|NCT00512850|Other|Placebo|One placebo pill per day
12010684|NCT00512837|Behavioral|Mobile phone technology|
12010685|NCT00512824|Dietary Supplement|low calcium milk of 180 ml|twice daily for 24 weeks
12010686|NCT00512824|Dietary Supplement|regular milk of 180 ml|twice daily for 24 weeks
12010687|NCT00512824|Dietary Supplement|regular milk of 180 ml + probiotics|twice daily for 24 weeks
12010688|NCT00512824|Dietary Supplement|regular milk of 180 ml + probiotics|twice daily for 24 weeks
12010689|NCT00512811|Drug|furosemide|
12010690|NCT00512798|Drug|PS-341 (VELCADE)|"Dose Levels PS-341 (day 1)
~Level -1 0.7 mg/m2
~Level 1 1.0 mg/m2
~Level 2 1.0 mg/m2
~Level 3 1.3 mg/m2
~Level 4 1.5 mg/m2"
12010691|NCT00512798|Drug|temozolomide|"Temozolomide (day 8)
~Level - 1 50 mg/m2
~Level 1 50 mg/m2
~Level 2 75/mg/m2
~Level 3 75 mg/m2
~Level 4 75 mg/m2"
12010692|NCT00512798|Other|immunoenzyme technique|Not noted
12010693|NCT00512798|Drug|PS-341 (VELCADE)|1.3 mg/m2 by IV on days 1, 4, 8, and 11 of every 21 days
12010694|NCT00512798|Drug|Temozolomide|75 mg/m2 by mouth, daily, during weeks 2-8 (42 days) of every 9-week course.
12010695|NCT00512785|Drug|imidafenacin, KRP-197/ONO-8025|0.1 mg BID for 52 weeks
12010696|NCT00512785|Drug|imidafenacin, KRP-197/ONO-8025|0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks
12010697|NCT00512759|Drug|Goal-directed preload and afterload decrement|Early goal-directed preload and afterload decrement with a target systolic blood pressure (RR) of 90-110 mmHg for the entire hospitalization using sublingual nitrates (Nitroglycerin Streuli®) or nitrospray (Corangin Nitrospray®) transdermal nitrates (Nitroderm TTS 10®), ACE-inhibitors (Triatec®) and/or ARB (Atacand®).
12010698|NCT00512746|Other|cytology and cytometry specimen collection procedure|Samples tested and further interventions added if positive
12010699|NCT00512746|Other|Chest x ray|Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.
12010700|NCT00512746|Procedure|Autofluorescence bronchoscopy|The bronchial tree will be inspected first under white light and then under blue light. All areas that appear abnormal will initially be documented and only sampled when the bronchoscopic examination has been completed.
12011083|NCT00509548|Drug|TG100801|Eye drop, twice a day, 30 days.
12010701|NCT00512746|Procedure|CT scan|All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
12010702|NCT00512707|Drug|Sildenafil citrate (open label)|On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
12010703|NCT00512707|Drug|Testosterone gel|Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
12010704|NCT00512707|Other|Placebo gel|3 tubes of placebo gel equivalent to the amount of the testosterone gel will be applied during the placebo-controlled testosterone gel intervention for 16 weeks..
12010705|NCT00512681|Drug|Irinotecan, Oxaliplatin, TS-1|"S-1 40 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
~Irinotecan 150 mg/m2 mixed in d5w 500 ml iv over 90-min on days 1
~Oxaliplatin 85 mg/m2 mixed in d5w 250 ml iv over 2-h on days 1"
12010706|NCT00512668|Drug|leuprolide acetate|Given intramuscularly
12010707|NCT00512668|Drug|goserelin acetate|Given subcutaneously
12010708|NCT00512668|Drug|bicalutamide|Given PO
12010709|NCT00512668|Drug|nilutamide|Given PO
12010710|NCT00512668|Drug|flutamide|Given PO
12010711|NCT00512668|Drug|temsirolimus|Given IV
12010712|NCT00512668|Other|laboratory biomarker analysis|Optional correlative studies
12010713|NCT00512655|Behavioral|Fall prevention course|Duration: 5 weeks, 2 sessions of 2 hours per week: 10 sessions in total.
12010714|NCT00512629|Drug|Omegaven|Omegaven is a fish based intravenous fat emulsion
12010715|NCT00512629|Drug|Intralipid|Intralipid is a plant based intravenous fat emulsion
12010716|NCT00512616|Drug|Ceftriaxone|
12010717|NCT00512590|Behavioral|Relaxation and Guided Imagery|"The intervention consisted of 3 relaxation and guided imagery audiotapes used in a proscribed order for 6 weeks and used in any order for weeks 7 through 10.
~Protocol: Tape 1: Basic Relaxation used for weeks 1 and 2. Tape 2: Pleasant Scene Imagery to elicit sensory involvement for enhanced sense of overall well-being; used for weeks 3 and 4. Tape 3: End-State Imagery designed to facilitate improved symptom management; used for weeks 5 and 6. Any of the tapes used as often as desired but at least once daily for weeks 7 to 10."
12010718|NCT00512577|Other|Red cell blood transfusion|
12010719|NCT00512564|Other|Laboratory analyses of iron overload|Summary of clinical status related to iron overload and laboratory analysis of Iron overload including Total serum Iron, Transferrin, Ferritin and Non transferrin Binding Iron and Labile Plasma Iron
12010720|NCT00512551|Procedure|Tumor Biopsies|Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.
12010721|NCT00512538|Device|Bi-layered cell therapy (Apligraf)|
12010722|NCT00512525|Drug|Ghrelin and saline (as placebo)|Intravenous infusion
12010723|NCT00512512|Procedure|Transoral Endoscopic Liver Biopsy|Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass
12010724|NCT00512499|Behavioral|Control group|Informing patient that fracture probably of fragility origin and suggesting to consult primary care practitioner. After 8 months, if not treated, Intensive intervention will be offered
12010725|NCT00512499|Behavioral|Minimal Intervention|Multiple layers of intervention will be added: results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations.
12010726|NCT00512499|Behavioral|Intensive Intervention|"INTENSIVE INTERVENTION GROUP: 1/2 of patients, randomly selected results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations.
~Sequential serum will be stored frozen in order to measure levels of blood markers of bone metabolism (at a later date)"
12010727|NCT00512486|Biological|MEDI-563|"BIW-8405/MEDI-563 administered at one of five dose levels:
~0.03 mg/kg intravenous injection
~0.1 mg/kg intravenous injection
~0.3 mg/kg intravenous injection
~1.0 mg/kg intravenous injection
~3.0 mg/kg intravenous injection
~Following the -3.0 mg/kg dose level,
~BIW-8405/MEDI-563 administered at one of two lower dose levels:
~0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection"
12010728|NCT00512473|Drug|Saline infusion|0.9 % NaCl
12010729|NCT00512473|Drug|Human Growth Hormone|0.5 mg genotropin administered as a bolus at t = 0
12010730|NCT00512473|Drug|Pegvisomant|30 mg Somavert administered at t = - 36 hours
12010731|NCT00512460|Drug|RTA 744|4.8 mg/m^2 by vein Over 2 Hours On Days 1-3.
12010732|NCT00512434|Procedure|Osteosynthesis|Nail or external fixator Intervention 'Osteosynthesis'
12010733|NCT00512421|Procedure|computer-assisted surgery|
12010734|NCT00512408|Drug|testosterone|
12010735|NCT00512395|Drug|epidural analgesia (Duracain/Fentanyl/Naropin)|naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h
12010736|NCT00512382|Device|WEEM - Wheezy Monitoring|loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
12010737|NCT00512356|Biological|Anti-Adhesion Product|Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components.
12010738|NCT00512317|Drug|ganaxolone|liquid suspension dosed tid
12010739|NCT00512304|Procedure|association chemotherapy and radiochemotherapy|
12010740|NCT00512291|Drug|Olanzapine|5 mg subcutaneous injection every 8 hours for 9 doses. Each injection should take about 1 to 2 minutes.
12010741|NCT00512278|Drug|Infliximab|Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
12010742|NCT00512278|Drug|Placebo|Placebo
12010743|NCT00512265|Drug|n-acetylcysteine|150mg/kg N-Acetylcysteine in 250mL Glucose 5% at time of induction of anaesthesia 50mg/kg N-Acetylcysteine in 250mL Glucose 5% on post-op days 1-3
12010744|NCT00512265|Drug|250mL glucose 5%|placebo (250mL glucose 5%) at time of induction of anaesthesia placebo (250mL glucose 5%) on post-op days 1-3
12010745|NCT00512252|Drug|AMD3100|
12010746|NCT00512252|Drug|Mitoxantrone|
12010747|NCT00512252|Drug|Etoposide|
12010748|NCT00512252|Drug|Cytarabine|
12010749|NCT00512226|Other|Cardiac and Liver T2* MRI|Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.
12010750|NCT00512213|Dietary Supplement|Immunonutrition for 5 days preoperative|Impact vs Meritene
12010751|NCT00512213|Dietary Supplement|Standard enteral nutrition for 5 days preoperative|Impact vs Meritene
12010752|NCT00512187|Other|low calorie diet|Low calorie diet was designed to achieve a loss of 5-10% of initial weight. All enrolled patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range 1200-1500 Kcal/day for women, 1300-1600 Kcal/day for men). Calorie intake consisted approximately of 60% carbohydrates, 25% fat, 15% protein
12010753|NCT00512174|Other|BladderScan BVI 3000|
12010754|NCT00512148|Device|Autologous neobladder construct|augmentation cystoplasty with autologous neo-bladder construct
12010755|NCT00512135|Drug|IncobotulinumtoxinA (Xeomin) (20 units)|Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.
12010756|NCT00512122|Other|Withholding PN during the first week of ICU stay|Patients in this arm will receive exclusively enteral nutrition. If enteral nutrition is insufficient after the seventh day of ICU stay, parenteral nutrition will be started.
12010757|NCT00512122|Drug|Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E|PN will be started the morning of the third ICU hospitalisation day. The amount of PN to be given will be calculated to cover the caloric needs of the patient, based on the enteral energy intake the previous 24 hours.
12010758|NCT00512096|Drug|Ifosfamide|1200 mg/m^2 By Vein Over 2 Hours on Days 1-3
12010759|NCT00512096|Drug|Paclitaxel (Taxol)|175 mg/m^2 By Vein Over 3 Hours on Day 1
12010760|NCT00512096|Drug|Cisplatin|25 mg/m^2 By Vein Over 2 Hours on Days 1-3
12010761|NCT00512083|Drug|AS1411|AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
12010762|NCT00512070|Drug|olanzapine and melatonin|In treatment phase I, all subjects will receive olanzapine, 10-25 mg/day. In treatment phase II, all subjects will receive olanzapine (10-25 mg/day) plus melatonin. Subjects will be randomized at a ratio of 1:1 to receive melatonin, 0.3 mg/day or 3.0 mg/day. Group IIA will receive 0.3mg day melatonin. Group IIB will receive 3.0 mg/day melatonin.
12010763|NCT00512057|Drug|allopurinol|allopurinol 300mg twice a day
12010764|NCT00512057|Drug|placebo|placebo
12010765|NCT00512044|Procedure|Local anesthesia (pudendal block)|local anesthesia as indicated
12010766|NCT00512044|Procedure|general anesthesia (spinal and general)|general according to guidelines
12010767|NCT00512018|Device|NMES|"In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES limbs).For the NMES, a symmetric double-phase sine-wave was used. Bearing wave frequency was of 2500 Hz, modulated in 50 bursts/s, with pulse duration of 200 µs, interburst interval of 10 ms. This configuration is known as Russian current."
12010768|NCT00512018|Other|Isokinetic exercise|Subjects realized training sessions twice a week with a 2-day minimum interval between the sessions, for 4 weeks. Each session included 5 min period of warm-up in a stationary bicycle, followed by 3 series of quadriceps stretching, as previously described. After being positioned at the isokinetic dynamometer, just as in the evaluation sessions, subjects firstly performed 3 sets of 10 maximum isokinetic concentric repetitions at the speed of 30º/s with one limb (EX limb), respecting the rest interval of 3 minutes between the sets.
12010769|NCT00512005|Device|Percutaneous mitral valve repair|Ventricular reshaping to treat functional mitral insufficiency
12010770|NCT00511992|Drug|Avastin|"Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
~Consolidation Treatment:
~Avastin 15mg/kg IV every 21 days x 12 cycles"
12010771|NCT00511992|Drug|Paclitaxel|Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
12010772|NCT00511992|Drug|Cisplatin|75mg/m2 IP day 2 every 21 days x 6 cycles
12010773|NCT00511979|Drug|Technosphere Insulin|
12010774|NCT00511979|Drug|Technosphere insulin|
12010775|NCT00511979|Drug|Technosphere insulin|
12010776|NCT00511979|Drug|Regular human insulin|
12010777|NCT00511966|Other|Non-Pharmacologic Treatment|Non-Pharmacologic Treatment
12010778|NCT00511966|Drug|Rabeprazole|As prescribed
12010779|NCT00511953|Drug|Gabapentin Extended Release tablets|1800mg
12010780|NCT00511953|Drug|Gabapentin|1800mg
12010781|NCT00511940|Drug|acamprosate|999 mg/day - 2997 mg/day, oral
12010782|NCT00511940|Other|placebo|oral, placebo
12010783|NCT00511914|Biological|cTIV|One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle
12010784|NCT00511901|Drug|placebo|
12010785|NCT00511901|Drug|epoetin alpha|
12010786|NCT00511901|Drug|Niferex|
12010787|NCT00511875|Drug|doxycycline monohydrate|50mg once daily for 24 months
12010788|NCT00511875|Drug|placebo|placebo taken once daily for 24 months
12010789|NCT00511862|Device|Yttrium 90 glass microspheres|120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe
12010829|NCT00511524|Drug|GW842166X|GW842166X will available with dose strength of 100 mg capsules. Four 100mg GW842166X capsules will be used for the 400 mg oral dose of GW842166X.
12010830|NCT00511524|Drug|[carbonyl-^11C]GW842166|[carbonyl-^11C]GW842166 will b available as Intravenous solution.
12010831|NCT00511498|Drug|Sildenafil|50 mg daily at bedtime
12011084|NCT00509535|Drug|vitreoscilla filiformis cream|
12010790|NCT00511849|Drug|carboplatin + SU011248 (sunitinib) + paclitaxel|AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.
12010791|NCT00511836|Drug|VIVITROL 380 mg|Administered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension.
12010792|NCT00511836|Drug|Placebo|Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.
12010793|NCT00511823|Drug|casopitant|The doses of casopitant will be comprised of 150 mg (one 150 mg tablet) and 50 mg (one 50 mg tablet). Casopitant will be taken with 240 milliliters (mL) of water on an empty stomach following at least 2 hour fast.
12010794|NCT00511823|Drug|dolasetron|The dose of oral dolasetron will be comprised of 100 mg (one 100 mg tablet or two 50 mg tablets). Dolasetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.
12010795|NCT00511823|Drug|granisetron|The dose of oral granisetron will be comprised of 2 mg (two 1 mg tablets). Granisetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.
12010796|NCT00511823|Drug|rosiglitazone|The dose of oral rosiglitazone will be comprised of 4 mg (two 2 mg tablets or one 4 mg tablet). Rosiglitazone will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.
12010797|NCT00511810|Drug|Low Dose Fish Oil|Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
12010798|NCT00511810|Drug|High Dose Fish Oil|Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
12010799|NCT00511797|Drug|SH T04740B|Drospirenone 1mg/EE 20µg (ß-CDC)
12010800|NCT00511797|Drug|SH T00186DF|Drospirenone 3 mg/EE 20µg (ß-CDC)
12010801|NCT00511797|Drug|SH T04740F|Drospirenone 2 mg/EE 20µg (ß-CDC)
12010802|NCT00511797|Drug|Placebo|Placebo
12010803|NCT00511771|Drug|Tegaserod|Tegaserod maleate
12010804|NCT00511758|Procedure|Digital Imaging|Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.
12010805|NCT00511745|Drug|Rabeprazol|As prescribed
12010806|NCT00511732|Drug|Technosphere Insulin|Technosphere Insulin Inhalation Powder
12010807|NCT00511732|Drug|Technosphere Placebo|Technosphere Inhalation Powder
12010808|NCT00511719|Drug|Technosphere Insulin|48U
12010809|NCT00511719|Drug|Actrapid|24IU
12010810|NCT00511706|Drug|dexamethasone|Intravitreal injection of dexamethasone 700 µg at Day 1.
12010811|NCT00511706|Biological|ranibizumab|Ranibizumab 500 µg at day -30 and Day 7-14.
12010812|NCT00511706|Other|sham|Sham needle-less injection administered in the study eye at Day 1.
12010813|NCT00511693|Behavioral|centralized osteoporosis coordinator|The regional osteoporosis coordinator will phone fracture patients and counsel them about their risk of osteoporosis, reiterating messages in the print material. The coordinator will also follow-up with family physicians by phone and send them a patient-specific reminder that informs them that their patient has experienced a fracture and they are at high risk for future fracture. As part of the reminder, a set of evidence-based recommendations about appropriate BMD testing and treatment based on the recent Canadian guidelines will be included. If the patient does not have a family physician, the regional osteoporosis coordinator will facilitate referral to the MOP.
12010814|NCT00511693|Behavioral|fall prevention|Fracture patients from hospitals receiving falls prevention advice will also be called by the osteoporosis regional coordinator. The patient will receive educational material and telephone counseling regarding fall prevention. During the call, patients will be encouraged to visit their family physician for fracture follow-up. They will not receive counseling or educational materials about osteoporosis at this time. Patients in the falls prevention group will receive the physician and patient osteoporosis program six months post-fracture.
12010815|NCT00511680|Behavioral|Behavioral Based In-Home Intervention|The 10 session intervention delivered by a social worker in the home includes five treatment components (education, referral, care management, stress reduction, behavioral activation). Each component has been shown to be effective in treating depression in previous research.
12010816|NCT00511667|Drug|MK0941|MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
12010817|NCT00511667|Drug|Comparator: Placebo|Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
12010818|NCT00511654|Drug|GW823296 tablet|GW823296 immediate release tablets will be available as white film-coated tablets containing 5 milligrams (mg) and 20 mg of GW823296 for oral administration.
12010819|NCT00511654|Drug|GW823296 matching placebo|Matching placebo tablets will be identical in appearance to the GW823296 tablets.
12010820|NCT00511654|Drug|Midazolam|Midazolam will be administered as 5 milliliter (mL) of an intravenous solution for oral application (5 mg/5 mL, Dormicum).
12010821|NCT00511641|Behavioral|Questionnaire|Questionnaires lasting up to 30 minutes.
12010822|NCT00511628|Drug|Risperidone|As prescribed
12010823|NCT00511615|Procedure|Loop Electrosurgical Excision Procedure (LEEP)|Tissue sample removed from cervix using LEEP and contrast agent.
12010824|NCT00511602|Drug|Technosphere Insulin|Technosphere Insulin Inhalation Powder
12010825|NCT00511602|Drug|Technosphere Placebo|Technosphere Inhalation Powder
12010826|NCT00511589|Other|chagas disease diagnostic|
12010827|NCT00511576|Drug|MGCD0103 & Docetaxel|"In both Parts 1 and 2, subsequent doses of MGCD0103 will be escalated in 25 mg increments until the MTD of MGCD0103 in combination with each fixed dose (60 mg/m2 or 75 mg/m2) ofIV docetaxel is determined.
~In both parts 1 and 2, MGCD0103 will be administered orally TIW for 3 weeks beginning on Day 1 at 1 hour prior to the start of the IV docetaxel infusion.
~There will be no scheduled break between cycles and no limit to the number of cycles a subject can receive provided they do not have disease progression as defined by RECIST, or a clinically significant drug-related adverse event (AE) that does not resolve or respond to treatment intervention with 3 weeks."
12010828|NCT00511563|Drug|GW876008 and GSK561679|GW876008 and GSK561679
12010927|NCT00510705|Other|exercise training|physical exercise training on a bicycle ergometer daily for 4 weeks
12010832|NCT00511485|Drug|Vintafolide|Induction: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance: vintafolide 2.5 mg intravenous injection, Monday, Wednesday, and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting.
12010833|NCT00511485|Drug|Etarfolatide|
12010834|NCT00511472|Drug|MK-0941|"In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.
~Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2."
12010835|NCT00511472|Drug|Placebo|10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
12010836|NCT00511472|Drug|LANTUS insulin|LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
12010837|NCT00511459|Drug|AMG 386 Placebo|AMG 386 Placebo [blinded]
12010838|NCT00511459|Drug|AMG 386|AMG 386 3mg/kg IV QW [blinded]
12010839|NCT00511459|Drug|Bevacizumab|Bevacizumab 10mg/kg IV Q2W
12010840|NCT00511459|Drug|AMG 386|AMG 386 10mg/kg IV QW [Open-Label]
12010841|NCT00511459|Drug|AMG 386|AMG 386 10mg/kg IV QW [blinded]
12010842|NCT00511459|Drug|Paclitaxel|Paclitaxel 90mg/m2 IV QW (3 on/1 0ff)
12010843|NCT00511446|Drug|docetaxel, oxaliplatin, capecitabine|"Docetaxel: 35 mg/m2, IV day 1, 8 of each 21 day cycle; Oxaliplatin: 70 mg/m2, IV day 1, 8 of each 21 day cycle; Capecitabine: 2x800 mg/m2 PO IV day 1 evening till morning of day 15 of each 21 day cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
12010844|NCT00511433|Drug|NOMAC-E2|"Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28
~for 6 consecutive 28-day menstrual cycles."
12010845|NCT00511433|Drug|DRSP-EE|Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.
12010846|NCT00511420|Dietary Supplement|Cocoa product type 1|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.
12010847|NCT00511420|Dietary Supplement|Cocoa product type 2|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
12010848|NCT00511420|Dietary Supplement|Cocoa product type 3|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
12010849|NCT00511420|Dietary Supplement|Cocoa product type 4|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
12010850|NCT00511407|Device|Renal tubule assist device|Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.
12010851|NCT00511394|Drug|20% Human Albumin|Infusion of 100 mL of 20% Albumin over 3 hours
12010852|NCT00511394|Drug|Normal Saline|Infusion of 100 mL of Normal Saline
12010853|NCT00511381|Genetic|No intervention|No intervention
12010854|NCT00511368|Drug|matching placebo|
12010855|NCT00511368|Drug|Bevirimat|
12010856|NCT00511355|Drug|NOMAC-E2|Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
12010857|NCT00511355|Drug|Levonorgestrel and Ethinyl Estradiol|Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
12010858|NCT00511342|Drug|NOMAC-E2|Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
12010859|NCT00511342|Drug|LNG-EE|Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
12010860|NCT00511329|Drug|somatropin [rDNA origin] for injection|Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
12010861|NCT00511316|Drug|Montelukast/ Singulair|20 mg daily for six months
12010862|NCT00511316|Drug|Placebo|Placebo 20 mg daily for 6 months
12010863|NCT00511303|Drug|STI571|
12010864|NCT00511290|Other|no generic names|
12010865|NCT00511277|Drug|Seroquel®|dosage form: oral, dosage: 300-800mg/d, frequency: twice daily
12010866|NCT00511238|Drug|carfilzomib|Subjects will receive carfilzomib 20 mg/m2 as an intravenous bolus over 2 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. A maximum of 12 cycles will be administered.
12010867|NCT00511238|Drug|carfilzomib|Subjects will receive carfilzomib intravenously over up to 10 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. In cycle 1, the dose is 20 mg/m2. If all doses are administered and well-tolerated over Cycle 1, beginning with Cycle 2 the dose will escalate to 27 mg/m2 cycle. A maximum of 12 cycles will be administered.
12010868|NCT00511225|Dietary Supplement|cholecalciferol|10,000 IU weekly
12010869|NCT00511225|Dietary Supplement|placebo|placebo capsule
12010870|NCT00511212|Drug|intravenous immunoglobulin|
12010871|NCT00511199|Drug|NOMAC-E2|"Nomegestrol Acetate and Estradiol Tablets, 2.5 mg
~NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year)."
12010872|NCT00511199|Drug|DRSP-EE|Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
12010873|NCT00511186|Drug|Placebo|placebo is administered intravenously over 48 hours. An initial loading dose of over 10-minutes is followed by continuous infusion over 48h.
12010874|NCT00511186|Drug|BIAP|AP is administered intravenously over 48 hours. An initial loading dose of 67.5U/Kg body weight over 10-minutes is followed by continuous infusion of 132.5U/Kg/24H administered over 48H
12010875|NCT00511173|Genetic|Warfarin Dose based on pharmacogenetics|Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm
12010876|NCT00511160|Procedure|Myocardial biopsies with TRU CUT 14 Gauge needle|Myocardial needle biopsy and right atrial appendectomy
12010877|NCT00511160|Procedure|Endomyocardial biopsies|The control arm C consists of routine-workup of patients with suspected myocarditis, independent of the study arm C, but with analogous screening methods and comparable biopsy sampling
12010878|NCT00511147|Biological|IGIV3I Grifols 10%|IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.
12010879|NCT00511134|Drug|Eszopiclone|eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule
12010880|NCT00511134|Drug|Bupropion|bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2.
12010881|NCT00511121|Drug|STI571 and PEG INTRON|
12010882|NCT00511108|Drug|Comparator: sitagliptin phosphate|sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
12010883|NCT00511108|Drug|Comparator: pioglitazone|pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
12010884|NCT00511108|Drug|Comparator: placebo to pioglitazone|pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
12010885|NCT00511108|Drug|Comparator: placebo to sitagliptin|sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
12010886|NCT00511095|Biological|HEPLISAV|Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
12010887|NCT00511082|Drug|OPB-31121|Patients will receive OPB-31121 administered orally, once daily for 4 weeks.
12010888|NCT00511069|Drug|Bortezomib|
12010889|NCT00511043|Drug|PTK787|PTK787 - 1250mg p.o. daily. Initial dose of 750mg p.o daily starting on day 1 and increased weekly to an intermediate dose of 1000 mg and then a target dose of 1250mg unless a grade ≥ 2 toxicity. Patients who tolerate the study target dose of 1250mg will remain on that dose until study completion at 12 months or until disease progression, unacceptable toxicity, withdrawal of consent or patient non-compliance with the protocol requirement.
12010890|NCT00511017|Drug|Doxercalciferol|.05 mcg/kg by mouth daily x 28 Days
12010891|NCT00511004|Drug|Albendazole|Comparing 400 mg to 800 mg dose
12010892|NCT00511004|Drug|Diethylcarbamazine|Providing diethylcarbamazine more frequently in combination with albendazole
12010893|NCT00510991|Device|nippv|
12010894|NCT00510978|Biological|Bifidobacterium infantis 35624|1 sachet/day for one year
12010895|NCT00510978|Biological|Lactobacillus salivarius UCC118|1 sachet per day for 1 year
12010896|NCT00510978|Biological|Placebo|1 sachet per day for 1 year
12010897|NCT00510965|Drug|Intravitreal injection ranibizumab|Monthly intravitreal injection of 0.5mg ranibizumab in one eye over one year
12010898|NCT00510952|Drug|Insulin Lispro Protamine Suspension|Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
12010899|NCT00510952|Drug|Insulin Glargine|Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
12010900|NCT00510939|Drug|Tipifarnib plus Bortezomib|
12010901|NCT00510926|Drug|Imatinib Mesilate (Glivec)|
12010902|NCT00510913|Drug|tacrolimus|
12010903|NCT00510887|Drug|Bortezomib|Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
12010904|NCT00510887|Drug|Rituximab|Rituximab 375 mg/m2 IV on day 1
12010905|NCT00510887|Drug|Fludarabine|Fludarabine 25 mg/m2 IV on days 1,2,3
12010906|NCT00510887|Drug|Mitoxantrone|Mitoxantrone 10 mg/m2 IV on day 2
12010907|NCT00510887|Drug|Dexamethasone|Dexamethasone 20 mg orally on days 1,2,3,4,5
12010908|NCT00510874|Biological|Pumarix™|Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
12010909|NCT00510874|Biological|Pandemrix ™|Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
12010910|NCT00510848|Procedure|autograft tendon|Reconstruction with an autograft tendon (hamstrings)
12010911|NCT00510848|Procedure|allograft tendon|Reconstruction with an allograft tendon (tibialis posterior)
12010912|NCT00510835|Procedure|Early Goal Directed Therapy (EGDT)|Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements.
12010913|NCT00510835|Procedure|Protocolized Standard Care (PSC)|Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status.
12010914|NCT00510835|Procedure|Usual Care (UC)|Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices.
12010915|NCT00510822|Drug|Cimicoxib|50 mg per tablet, bid (total daily dose 100 mg)
12010916|NCT00510822|Drug|Placebo|tablet
12010917|NCT00510809|Drug|Policosanol|Policosanol 20 mg daily
12010918|NCT00510809|Other|Placebo|Placebo daily
12010919|NCT00510809|Drug|Policosanol Plus Already In Use Statin Therapy|Policosanol 20 mg daily Statin Therapy
12010920|NCT00510796|Behavioral|Interview|Interview regarding perception of pain and the benefits and barriers to the combined screening.
12010921|NCT00510783|Drug|Keppra|The patient will receive 1 gram of Keppra added to 100ml diluent and will be infused over 15 minutes.
12010922|NCT00510783|Drug|Fosphenytoin|IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals.
12010923|NCT00510783|Drug|Dilantin|IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals.
12010924|NCT00510770|Device|CPAP application|
12010925|NCT00510744|Drug|pancreatic enzyme supplement|4 caps with meals, 2 with snacks
12010926|NCT00510718|Drug|MDV3100|MDV3100 daily until progression or dose-limiting toxicity
12010928|NCT00510705|Other|exercise training + metformin|physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks
12010929|NCT00510705|Other|exercise training + glitazone|physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks
12010930|NCT00510692|Drug|Eicosapentanoic Acid (EPA)|2 x 500mg EPA capsules twice daily for 6 months
12010931|NCT00510692|Procedure|Endoscopy|Endoscopy with video and photographs at baseline and month 6.
12010932|NCT00510692|Procedure|Biopsies taken|9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
12010933|NCT00510692|Drug|Placebo|2 x 500mg placebo capsules twice daily for 6 months
12010934|NCT00510679|Behavioral|Health worker supports (supervision, job aids, incentives)|
12010935|NCT00510666|Drug|Saline|Saline infusion adjunct to morphine PCA pump
12010936|NCT00510666|Drug|Butorphanol tartrate|Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
12010937|NCT00510666|Drug|Tramadol Hydrochloride|100mg tramadol was used preemptively to morphine PCA pump
12010938|NCT00510666|Drug|Saline|Preemptive saline as a control group to tramadol one
12010939|NCT00510653|Drug|Imatinib Mesylate|600 mg by mouth daily for 6 Weeks
12010940|NCT00510640|Drug|Sunitinib|Capsule, 12.5 or 50 mg, starting dose level 50 mg daily
12010941|NCT00510627|Device|Radiofrequency Ablation (RFA)|The RF3000 radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue.
12010942|NCT00510627|Drug|Chemotherapy|Standard of care chemotherapy regimen
12010943|NCT00510614|Drug|tinidazole|1 gram twice weekly for 12 weeks
12010944|NCT00510614|Drug|Placebo|one pill twice weekly for 12 weeks
12010945|NCT00510601|Device|Kaneka Liposorber|LDL-apheresis on a bi-weekly basis
12010946|NCT00510588|Other|training|regular physical exercise training for 6 months
12010947|NCT00510588|Other|training + metformin|regular physical exercise training in combination with metformin for 6 months
12010948|NCT00510588|Other|training + glitazon|regular physical exercise training in combination with a glitazon for 6 months
12010949|NCT00510575|Device|Spinal rod|Posterior spinal fusion using a 5.5 or 6.35 size rod
12010950|NCT00510562|Procedure|Cranial osteopathic manipulation|This treatment is performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.
12010951|NCT00510562|Procedure|Sham/Placebo|A laying on of hands with no treatment being performed.
12010952|NCT00510549|Procedure|Modality: Peritoneal Dialysis|Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
12010953|NCT00510536|Drug|Acetaminophen|dose to be determined by investigator
12010954|NCT00510536|Drug|NSAID|dose to be determined by investigator
12010955|NCT00510523|Device|Whole Body Vibration machine|
12010956|NCT00510510|Drug|NVA237 100 µg|Dry powder inhalation once a day for up to 28 days
12010957|NCT00510510|Drug|Placebo|Placebo to NVA237 dry powder inhalation once a day for up to 28 days
12010958|NCT00510510|Drug|NVA237 200 µg|Dry powder inhalation once a day for up to 28 days
12010959|NCT00510497|Biological|Autologous HIV-1 ApB DC Vaccine|Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
12010960|NCT00510484|Drug|Pancrelipase Delayed Release|24000 unit Capsule
12010961|NCT00510484|Drug|Placebo Comparator|Placebo
12010962|NCT00510471|Drug|autologous immunoglobulin idiotype-KLH conjugate vaccine|
12010963|NCT00510458|Device|LFIT™ Femoral Heads With X3® Insert|LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
12010964|NCT00510445|Drug|Imetelstat Sodium (GRN163L)|"The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg.
~Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle."
12010965|NCT00510419|Drug|"InvestigationalAuto-injector (sumatriptan succinate)"|
12010966|NCT00510406|Drug|tamsulosin hydrochloride|Alphablocker
12010967|NCT00510406|Drug|solifenacin succinate|antimuscarinic
12010968|NCT00510406|Drug|Placebo|Placebo
12010969|NCT00510393|Device|XIENCE V everolimus eluting coronary stent system|
12010970|NCT00510393|Device|MULTILINK VISION coronary stent system|
12010971|NCT00510367|Drug|5-Fluorouracil|500 mg/m^2 By Vein Daily x 2 Days
12010972|NCT00510367|Drug|Cyclophosphamide|500 mg/m^2 By Vein On Day 1
12010973|NCT00510367|Drug|Doxorubicin|50 mg/m^2 By Vein Over 72 Hours
12010974|NCT00510354|Drug|Imatinib mesylate|
12010975|NCT00510341|Behavioral|Collaborative Management in Pediatrics (CMP) Program|Pediatric residents will receive two 4.5 hour training sessions on the CMP Program.
12010976|NCT00510328|Device|Whole Body Vibration|
12010977|NCT00510315|Other|Questionnaires, Laboratory tests, Abdominal MRI|Height, weight, waist and hip circumference; systolic and diastolic blood pressure; questionnaires; fasting blood tests: insulin, glucose, lipids (low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, LDL pattern, HDL and LDL subspecies), cardiac inflammatory markers (hsCRP, IL-1B, IL-6, IL-10, TNFa), leptin, adiponectin, IGF-1, and IGFBP3; abdominal MRI for visceral and subcutaneous fat measurement
12010978|NCT00510302|Behavioral|Questionnaire|Questionnaire regarding melanoma risk-reduction.
12010979|NCT00510302|Behavioral|Interview|Interview via telephone about topics related to melanoma risk-reduction.
12010980|NCT00510289|Drug|Sorafenib|400 mg twice a day until progression or unacceptable toxicity develops.
12010981|NCT00510276|Drug|Atomoxetine hydrochloride|20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
12010982|NCT00510276|Drug|Placebo|twice a day, by mouth for 12 weeks
12010983|NCT00510263|Drug|Prednisolone + placebo|Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.
12011074|NCT00509613|Drug|Sirolimus|
12010984|NCT00510263|Drug|Valaciclovir + placebo|Valaciclovir 500 mg 2 tablets 3 times daily for 7 days. Placebo tablets 12 per day for 5 days, tapering 2 tablets per day until day 10.
12010985|NCT00510263|Drug|Prednisolone + valaciclovir|Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Valaciclovir 500 mg 2 tablets 3 times daily for 7 days.
12010986|NCT00510263|Drug|Placebo + placebo|Placebo 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.
12010987|NCT00510250|Drug|Sorafenib|200mg PO BID x 7 days prior to Radiation and Cisplatin for Low-Risk Patients or 200mg PO BID x 7 days prior to, and 35 days during Radiation and Cisplatin for High-Risk Patients
12010988|NCT00510250|Drug|Cisplatin|40mg/m2 administered weekly via IV, with Radiation
12010989|NCT00510250|Procedure|Radiation|Administered for 30-40 days.Combination of external beam radiotherapy followed by intra-cavitary brachytherapy.
12010990|NCT00510237|Behavioral|"Adolescents Coping, Connecting, Empowering, and Protecting Together (Project ACCEPT)"|The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session.
12010991|NCT00510224|Drug|Sandostatin|Sandostatin 30mg intramuscular every 28 days
12010992|NCT00510211|Drug|olanzapine|
12010993|NCT00510198|Device|Cardiac Compass with OptiVol Fluid Status Monitoring|Review of Cardiac Compass with OptiVol Fluid Status Monitoring
12010994|NCT00510198|Device|Standard of Care alone (clinical assessment)|Clinical assessment utilizing standard of care, alone.
12010995|NCT00510185|Other|systematic coronary intervention|Coronary angiography within 72 hrs
12010996|NCT00510185|Other|coronary intervention only for cases refractory to medical therapy|Initially conservative treatment with coronary angiography only for recurrent ischemia
12010997|NCT00510172|Drug|Prostacyclin, PGI2|10 ng/kg/min of epoprostenol (stable PGI2)
12010998|NCT00510172|Drug|Placebo|NaCL 0,9%
12010999|NCT00510159|Drug|Artesunate+Sulfamethoxypyrazine/pyrimethamin|
12011000|NCT00510159|Drug|Praziquantel|
12011001|NCT00510146|Drug|Olanzapine|5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).
12011002|NCT00510146|Drug|Placebo|placebo tablets, oral, once daily at bedtime, 6 weeks
12011003|NCT00510133|Biological|GRNVAC1|Autologous dendritic cell vaccine
12011004|NCT00510120|Behavioral|Parent management training (PMT)|PMT primarily involves teaching parents strategies to respond consistently and correctly to their child's behavior. Parents assigned to the PMT group will be taught how to respond consistently and appropriately to their child's positive and negative behaviors. Participants will attend a 1-hour treatment session each week for 10 weeks.
12011005|NCT00510120|Behavioral|Collaborative problem solving (CPS)|CPS is a treatment approach that involves both the parent and child by teaching parents to help their child control their emotions and to problem solve as a family. Parents assigned to the CPS group will be taught strategies to help their child identify and regulate emotions and to solve behavior problems together as a family. Participants will attend a 1-hour treatment session each week for 10 weeks.
12011006|NCT00510120|Behavioral|Waitlist control|Participants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options.
12011007|NCT00510107|Drug|oxaliplatin|oxaliplatin 120 mg/m2 will be given on day 1.
12011008|NCT00510107|Drug|Cisplatin|Cisplatin 60 mg/m2 will be given on day 1.
12011009|NCT00510094|Behavioral|Friend to Friend program|Friend to Friend arm is a social information processing group treatment to help aggressive girls learn better social problem solving and decision making choices. Participants will learn how to identify signs of physiological arousal, evaluate others' intentions, react to a potential conflict situation, and generate and evaluate alternatives. Treatment sessions are twice per week (30 to 40 minutes per session) for ten weeks.
12011010|NCT00510094|Behavioral|Psychoeducational attention control intervention|Psychoeducational attention control group also meets two times per week for 10 weeks to control for nonspecific factors of treatment. Participants learn homework, study skills, and organizational skills.
12011011|NCT00510081|Device|Calcium Hydroxylapatite injection|filler injection
12011012|NCT00510068|Drug|Everolimus|A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.
12011013|NCT00510068|Drug|Everolimus Placebo|a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.
12011014|NCT00510055|Procedure|subdermal manipulation ONLY|scars receive subdermal manipulation ONLY
12011015|NCT00510055|Procedure|subdermal manipulation AND injection of a filler|scars receive subdermal manipulation AND injection of a filler
12011016|NCT00510029|Drug|GAP-134|atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO
12011017|NCT00510016|Drug|Clonidine HCL|Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
12011018|NCT00510003|Drug|Pimecrolimus|Pimecrolimus cream 1 %
12011019|NCT00509990|Drug|Pimecrolimus|Pimecrolimus cream 1 %
12011020|NCT00509977|Procedure|Light Treatment|Light treatment applied to half of the face at each study visit
12011021|NCT00509977|Procedure|Laser Treatment|Laser treatment applied to half of the face at each study visit
12011022|NCT00509964|Drug|irinotecan|Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
12011023|NCT00509964|Drug|ILF|Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.
12011024|NCT00509951|Behavioral|One-session exposure treatment|Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner.
12011075|NCT00509600|Drug|Etanercept|0.8 mg/kg Subcutaneously Once A Week for 90 Days
12011076|NCT00509587|Drug|pazopanib hydrochloride|Given orally
12011077|NCT00509587|Procedure|pharmacological study|Correlative studies
12011025|NCT00509951|Behavioral|Augmented one-session exposure treatment|Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session.
12011026|NCT00509938|Drug|human lactoferrin peptide 1-11|Each subject will receive a single intravenous dose of hLF1-11 given in a volume of 20mL given over 20 minutes i.e. 1mL/per minute.
12011027|NCT00509925|Drug|insulin detemir|Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
12011028|NCT00509925|Drug|insulin NPH|Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
12011029|NCT00509925|Drug|insulin aspart|Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
12011030|NCT00509899|Drug|Ruxolitinib|5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.
12011031|NCT00509886|Drug|Drysol|20% aluminum chloride hexahydrate
12011032|NCT00509886|Drug|Drioff|1% aluminum acetate
12011033|NCT00509873|Drug|Gatifloxacin 0.5% eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
12011034|NCT00509873|Drug|placebo eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
12011035|NCT00509860|Drug|Irinotecan|16 mg/m2 by vein Daily Over 1 Hour x 5 Days
12011036|NCT00509847|Drug|human lactoferrin peptide 1-11|(A) hLF1-11 (once-daily 0.5mg IV for 10 days): Group #1, n=10; OR (B) Placebo (to match hLF1-11): Group #2, n=10
12011037|NCT00509834|Drug|hLF1-11|"The study treatment consists of IV administration of:
~(A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10"
12011038|NCT00509834|Drug|hLF1-11|0.5mg hLF1-11 iv per day for 14 consecutive days
12011039|NCT00509834|Drug|Placebo|Placebo
12011040|NCT00509821|Drug|Enzastaurin 500 milligram (mg) Once Daily (QD)|1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression, given with and without radiotherapy treatment.
12011041|NCT00509821|Drug|Enzastaurin 250 mg Twice Daily (BID)|1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression, given with and without radiotherapy treatment.
12011042|NCT00509808|Device|Electrostimulation|"1st month GN wearing (activated or sham mode)
~2nd month wearing (opposite mode)
~3rd - 5th month: activated GN wearing for 1, 5 or 10 minutes
~6th - 8th month: activated GN wearing for 1, 5 or 10 minutes
~9th - 11th month: activated GN wearing for 1, 5 or 10 minutes"
12011043|NCT00509795|Biological|ranibizumab|Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
12011044|NCT00509795|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
12011045|NCT00509795|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received a 0.5mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
12011046|NCT00509795|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
12011047|NCT00509782|Drug|ZIO-101|Starting Dose 78 mg/m^2 intravenously daily for 5 consecutive days repeated every 4 weeks.
12011048|NCT00509769|Drug|Trastuzumab emtansine [Kadcyla]|Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.
12011049|NCT00509756|Drug|FXR-450|capsule, single oral doses from 10 mg to 450 mg
12011050|NCT00509756|Drug|Placebo|capsule similar to active drug
12011051|NCT00509743|Drug|Intravenous diclofenac sodium (DIC075V)|High dose Diclofenac
12011052|NCT00509743|Drug|Intravenous diclofenac sodium (DIC075V)|Low Dose Diclofenac
12011053|NCT00509730|Procedure|Urodynamics|
12011054|NCT00509717|Other|intensive implementation programme|educational manual; interactive educational meeting tailored to individual needs; reminders and feedback by 3 newsletters and at least 3 telephone calls.
12011055|NCT00509717|Other|control|educational manual
12011056|NCT00509691|Biological|cytomegalovirus pp65-specific cytotoxic T lymphocytes|
12011057|NCT00509691|Genetic|polymerase chain reaction|
12011058|NCT00509691|Other|diagnostic laboratory biomarker analysis|
12011059|NCT00509691|Other|flow cytometry|
12011060|NCT00509691|Other|immunologic technique|
12011061|NCT00509678|Drug|Rituximab|1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
12011062|NCT00509665|Drug|doxorubicin hydrochloride|given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
12011063|NCT00509665|Drug|gemcitabine hydrochloride|given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
12011064|NCT00509652|Procedure|Arm 1: Erythrocyte apheresis|Erythrocyte apheresis
12011065|NCT00509652|Procedure|Arm 2: Whole blood phlebotomy|Traditional whole blood phlebotomy
12011066|NCT00509639|Drug|10% Metronidazole Ointment|Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks
12011067|NCT00509626|Behavioral|exercise intervention|
12011068|NCT00509626|Other|questionnaire administration|
12011069|NCT00509626|Procedure|CAM exercise therapy|
12011070|NCT00509626|Procedure|management of therapy complications|
12011071|NCT00509626|Procedure|psychosocial assessment and care|
12011072|NCT00509626|Procedure|quality-of-life assessment|
12011073|NCT00509613|Drug|Sorafenib|
12011085|NCT00509496|Drug|fludarabine phosphate|25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days.
12011086|NCT00509496|Drug|cyclophosphamide|60 mg/kg/day x 2 days intravenous
12011087|NCT00509496|Biological|aldesleukin|720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
12011088|NCT00509496|Biological|autologous anti-gp 100:154-162 T-cell receptor gene-engineered tumor infiltrating lymphocytes|"Patients will receive a minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL .
~The cells are infused intravenously over 20-30 minutes."
12011089|NCT00509496|Biological|autologous anti-gp 100:154-162 T-cell receptor gene-engineered peripheral blood lymphocytes|"Patients will receive a minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered PBL.
~The cells are infused intravenously over 20-30 minutes."
12011090|NCT00509483|Radiation|Radioactive iodine|Radioactive iodine preceded by rhTSH
12011091|NCT00509470|Drug|telmisartan plus hydrochlorothiazide|Combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day
12011092|NCT00509470|Device|Amlodipine|
12011093|NCT00509457|Biological|GV 1001 Telomerase peptide|
12011094|NCT00509444|Behavioral|Educational materials|
12011095|NCT00509444|Behavioral|educational materials, plus patient navigation|
12011096|NCT00509431|Drug|Erlotinib + Sirolimus|In arm I of dose escalation phase,starting dose of erlotinib is 150 mg daily. Starting dose of sirolimus includes a 15 mg loading dose, followed by continuous dosing at 5 mg daily.Dose escalation will proceed according to protocol Phase II of the study was not conducted only Phase I
12011097|NCT00509418|Dietary Supplement|Viusid|Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
12011098|NCT00509418|Other|Hypocaloric Diet with controlled exercise|Modified ADA diet in combination with controlled exercise daily 24 weeks
12011099|NCT00509405|Drug|potassium citrate|6 times 10 mEq per day, oral for 24 months
12011100|NCT00509392|Device|Seg. RF Ablation & ClosureFAST catheter|Seg. RF Ablation & ClosureFAST catheter
12011101|NCT00509392|Device|Endovenous Laser|laser catheter
12011102|NCT00509379|Drug|Rituximab|Rituximab 375 mg/m2 as slow iv infusion day 1-8-15-22.Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
12011103|NCT00509379|Drug|VELCADE|VELCADE 1,6 mg/m2 iv bolus days 1-8-15-22 (Velcade will be administrated prior of Rituximab infusion).Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
12011104|NCT00509366|Drug|Cisplatin & Gemcitabine|"Squamous Cell NSCLC:
~Gemcitabine 1250 mg/m2 IV over 30 minutes day 1 and 8, followed by Cisplatin 75 mg/m2 IV over 60 minutes day 1; repeat every 21 days for up to 6 cycles"
12011105|NCT00509366|Drug|Cisplatin & Pemetrexed|"Non-Squamous Cell NSCLC:
~Pemetrexed 500 mg/m2 IV over approximately 10 minutes day 1, followed by Cisplatin 75 mg/m2 IV over 60 minutes day 1; repeat every 21 days for up to 6 cycles"
12011106|NCT00509366|Drug|Docetaxel & Gemcitabine|"Squamous Cell NSCLC:
~Docetaxel 75 mg/m2 IV over 60 minutes day 1, followed by Gemcitabine 1250 mg/m2 IV over 30-60 minutes day 1 and alone day 8; repeat every 21 days for up to 6 cycles"
12011107|NCT00509366|Drug|Pemetrexed & Gemcitabine|"Non-Squamous Cell NSCLC:
~Pemetrexed 500 mg/m2 IV over approximately 10 minutes day 1, followed by Gemcitabine 1250 mg/m2 IV over 30-60 minutes day 1 and alone day 8; repeat every 21 days for up to 6 cycles"
12011108|NCT00509353|Drug|irinotecan hydrochloride|
12011109|NCT00509353|Drug|vincristine sulfate|
12011110|NCT00509353|Radiation|iobenguane I 131|
12011111|NCT00509340|Behavioral|Cognitive behavioral therapy (CBT)|Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.
12011112|NCT00509327|Drug|bisacodyl|10mg capsule twice daily from one day preoperatively to day three postoperatively
12011113|NCT00509327|Drug|glucosemonohydricum|10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative
12011114|NCT00509314|Behavioral|melanocyte self-assembly and functional analysis|
12011115|NCT00509301|Drug|131-I-chTNT-1/B MAB|The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.
12011116|NCT00509288|Biological|autologous anti-MART-1 F5 T-cell receptor|"Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes.
~A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL."
12011117|NCT00509288|Drug|Cyclophosphamide|Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
12011118|NCT00509288|Drug|Fludarabine|Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days
12011119|NCT00509288|Biological|Aldesleukin|Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion
12011120|NCT00509288|Biological|autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes|
12011121|NCT00509275|Drug|W0027|capsule
12011122|NCT00509275|Drug|Placebo|Placebo
12011123|NCT00509262|Drug|Sitagliptin|Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
12011124|NCT00509262|Drug|Glipizide|Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
12011125|NCT00509262|Drug|Placebo for Sitagliptin|Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
12011126|NCT00509262|Drug|Placebo for Glipizide|Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
12011127|NCT00509249|Biological|ziv-aflibercept|Given IV
12011128|NCT00509249|Other|laboratory biomarker analysis|Correlative studies
12011130|NCT00509236|Drug|Sitagliptin|25 mg (one 25-mg tablet) once daily
12011131|NCT00509236|Drug|Glipizide|2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg
12011132|NCT00509223|Device|Positive Airway Pressure therapy|Positive Airway Pressure (PAP) therapy initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep.
12011133|NCT00509223|Behavioral|Lifestyle counseling|Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
12011134|NCT00509210|Drug|telaprevir (VX-950)|
12011135|NCT00509197|Drug|Placebo (sham inhaler)|
12011136|NCT00509197|Drug|Fluticasone|Fluticasone 250mcg bid for one month
12011137|NCT00509184|Drug|Rituximab|375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap
12011138|NCT00509171|Device|Reamer Irrigator Aspirator|Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
12011139|NCT00509158|Biological|arm I: PfLSA-3-rec with aluminium hydroxide as adjuvant|
12011140|NCT00509158|Biological|arm 2: PfLSA-3-rec with Montanide Isa 720 as adjuvant|
12011141|NCT00509145|Drug|Laquinimod|Laquinimod 0.6 mg capsule, oral, once daily
12011142|NCT00509145|Other|Placebo|oral, once daily, capsule
12011143|NCT00509132|Drug|trodusquemine|
12011144|NCT00509106|Drug|Ceftaroline fosamil for Injection|2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
12011145|NCT00509106|Drug|Ceftriaxone|1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days
12011146|NCT00509106|Drug|Placebo|Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
12011147|NCT00509093|Drug|imatinib mesylate|Patients will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. The study dose can be split but the dose of 600 mg must be given within a 12 hour period.
12011148|NCT00509093|Genetic|gene expression analysis|Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
12011149|NCT00509093|Genetic|mutation analysis|FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
12011150|NCT00509093|Genetic|polymerase chain reaction|AF1q gene analysis (on bone marrow aspirate)
12011151|NCT00509093|Other|flow cytometry|C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated as the c-kit mean channel number (MCN) of the blasts/ MCN auto fluorescence.
12011152|NCT00509093|Procedure|biopsy|Diagnostic bone marrow biopsy/aspirate must be done within 3 weeks of registration documenting complete remission
12011153|NCT00509067|Drug|Galantamine|Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.
12011154|NCT00509067|Drug|CDP-choline|CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.
12011155|NCT00509067|Drug|Placebo|The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.
12011156|NCT00509067|Drug|risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole|All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.
12011157|NCT00509054|Procedure|Prophylactic mesh|A low weigth partly absorbable mesh in a subaly posistion
12011158|NCT00509041|Drug|dasatinib|50 mg PO bid
12011159|NCT00509028|Drug|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
12011160|NCT00509028|Drug|Conventional Asthma Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
12011161|NCT00509015|Drug|Sulphadoxine-pyrimethamine (day 1: 500mg S&25mg P/20 kg)|500mg S&25mg P/20 kg, 1 day, single dose
12011162|NCT00509015|Drug|Artesunate (day 1,2,3: 4 mg/kg)|4 mg/kg, daily single dose over three days
12011163|NCT00509015|Drug|Primaquine-base (day 3: 0.75 mg/kg)|single dose at 0.75 mg/kg on day 3
12011164|NCT00509015|Drug|placebo tablets|3 days of lactose tablets (160mg) albochin
12011165|NCT00509002|Drug|Gefitinib|250 mg by mouth once a day, every day, at about same time in morning.
12011166|NCT00508989|Drug|Niacin-ER|500 mg daily for 4 weeks, 1000 mg daily for 4 weeks, and 1500 mg daily for 4 weeks
12011167|NCT00508989|Drug|Placebo|500 mg daily for 4 weeks, 1000 mg daily for 4 weeks, and 1500 mg daily for 4 weeks
12011168|NCT00508989|Drug|L-NMMA|
12011169|NCT00508989|Drug|Acetylcholine|
12011170|NCT00508976|Drug|Injected bupivacaine post-operatively|Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation, and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
12011267|NCT00508300|Procedure|Epidural analgesia|Thoracic epidural analgesia until day 2
12011323|NCT00507923|Other|Sleep Diary|Complete sleep diary
12011171|NCT00508976|Drug|Streamed bupivacaine versus streamed normal saline|Patients will receive 30ml of 0.9% normal saline divided equally and injected prior to port site incisions, then 10ml of 0.5% bupivacaine streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
12011172|NCT00508976|Drug|Aerosolized bupivacaine versus aerosolized saline|Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.5% bupivacaine aerosolized into coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
12011173|NCT00508976|Drug|Injected lidocaine pre-incision vs saline pre-incision|Patients will receive 30ml of 1% lidocaine divided equally and injected prior to port site incisions, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
12011174|NCT00508963|Drug|sodium stibogluconate (Pentostam)|20 mg/kg IV every day for 20 or 28 days
12011175|NCT00508950|Procedure|Large volume blood draw|Large volume blood draw
12011176|NCT00508937|Other|Diet|15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)
12011177|NCT00508937|Other|Diet|20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)
12011178|NCT00508937|Other|Diet|20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)
12011179|NCT00508937|Other|Diet|30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)
12011180|NCT00508937|Other|Diet|30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)
12011181|NCT00508924|Drug|Argatroban|
12011182|NCT00508924|Drug|Argatroban|
12011183|NCT00508924|Drug|Argatroban|
12011184|NCT00508924|Drug|Heparin|
12011185|NCT00508911|Drug|GW876008|GW876008 tablets will be available as white to off-white coated tablets. Each subject will receive a single oral dose of GW876008, daily for up to 35 days in Session 2. GW876008 will be administered in the morning with a light breakfast.
12011186|NCT00508911|Drug|COC|COC containing ethinylestradiol 30 microgram and levonorgestrel 150 microgram will be administered in the morning with a light breakfast.
12011187|NCT00508898|Drug|Calcitriol|Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.
12011188|NCT00508898|Drug|Multivitamin|Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
12011189|NCT00508885|Drug|Niacinamide|Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
12011190|NCT00508885|Drug|Placebo|Placebo
12011191|NCT00508872|Drug|5-Fluorouracil|400 mg/m^2 IV over 15 minutes, followed by 2400 mg/m^2 IV Over 46 Hours
12011192|NCT00508872|Drug|Bevacizumab|5 mg/kg IV Over 30-90 Minutes On Day 1 Every 14 Days
12011193|NCT00508872|Drug|Leucovorin|400 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
12011194|NCT00508872|Drug|Oxaliplatin|85 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
12011195|NCT00508859|Drug|Sertraline|maintenance treatment with sertraline
12011196|NCT00508859|Drug|placebo|placebo
12011197|NCT00508846|Behavioral|Questionnaire|Two-part telephone questionnaire lasting about 60 minutes total.
12011198|NCT00508833|Biological|287615 containing HBsAg with adjuvants|
12011199|NCT00508820|Biological|Romiplostim|Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.
12011200|NCT00508807|Drug|RTA 402|5 mg by mouth (PO) daily for 21 days
12011201|NCT00508794|Behavioral|Yoga Group|3 sessions of yoga each week for 6 weeks.
12011202|NCT00508794|Behavioral|Stretching Control Group|3 sessions of stretching each week for 6 weeks
12011203|NCT00508794|Behavioral|Waitlist Control Group|Option of participating in the yoga or stretching program after the study has ended.
12011204|NCT00508794|Other|Questionnaire|Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
12011205|NCT00508781|Behavioral|Multiphoton laser image in cutaneous pathology|
12011206|NCT00508768|Drug|Oral SCIO-469 capsule|
12011207|NCT00508755|Device|Gait Robot|gait training with the use of a gait robot
12011208|NCT00508755|Device|Functional Neuromuscular stimulation with intramuscular electrodes|gait training with use of functional electrical stimulation
12011209|NCT00508742|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose at 2, 4, 6 and 12 months of age
12011210|NCT00508742|Biological|7 valent pneumococcal conjugate vaccine|1 dose at 2, 4, 6 and 12 months of age
12011211|NCT00508729|Drug|Qingyi granules|
12011212|NCT00508716|Behavioral|Health Literacy-Tailored Education|Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials.
12011213|NCT00508703|Radiation|Intensity Modulated Radiotherapy (IMRT)|Dose of 45Gy
12011214|NCT00508703|Procedure|CT Scan|CT Scans: Twice a week during the 5 weeks of radiation treatment.
12011215|NCT00508690|Drug|cefmetazole|Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
12011216|NCT00508690|Drug|kanamycin/metronidazole|2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
12011217|NCT00508664|Radiation|Radiation|Radiation start in week 11
12011218|NCT00508664|Drug|Cetuximab|Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks
12011219|NCT00508664|Drug|Docetaxel|75 mg/m2 i.v. day 1 3 times
12011220|NCT00508664|Drug|Cisplatin (TP)|75 mg/m2 i.v. day 1 3 times
12011221|NCT00508664|Drug|5-Fluorouracil (TPF) (only until Feb 2009)|Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
12011268|NCT00508300|Procedure|Patient controlled analgesia|Patient controlled analgesia (morphine-based)
12011222|NCT00508651|Biological|MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.
12011223|NCT00508651|Biological|Placebo|Placebo was a frozen preparation filled into Becton Dickinson^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
12011224|NCT00508625|Drug|AMG 951 (rhApo2L/TRAIL)|AMG 951 is recombinant human Apo2Ligand/Tumor necrosis factor related apoptosis inducing ligand (rhApo2L/TRAIL) that triggers apoptosis through activation of death receptor 4 (DR4) and death receptor 5 (DR5).
12011225|NCT00508625|Drug|Bevacizumab|Bevacizumab is a recombinant humanized version of a murine antibody to vascular endothelial growth factor (VEGF).
12011226|NCT00508625|Drug|Carboplatin|Standard platinum based chemotherapy
12011227|NCT00508625|Drug|Paclitaxel|Standard taxane chemotherapy
12011228|NCT00508612|Behavioral|Williams LifeSkills Stress and Anger Management Workshop|Williams LifeSkills Stress and Anger Management Workshop
12011229|NCT00508612|Behavioral|High school classes|The control group will attend regular high school classes.
12011230|NCT00508599|Other|Study 2 (48 hours of complete bed rest)|Effects of 48 hours of bed rest on insulin resistance in type 2 diabetic subjects.
12011231|NCT00508586|Drug|PTC299|PTC299 orally administered twice per day given in combination with anastrozole (Arimidex®), letrazole (Femara®), or exemestane (Aromasin®)
12011232|NCT00508573|Behavioral|Questionnaire|Follow-up questionnaire done once a year for five years.
12011233|NCT00508560|Behavioral|Contingency Management|"Participants draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Tokens include messages of encouragement (Good job!) or VA canteen vouchers of varying monetary value."
12011234|NCT00508560|Behavioral|Reward|Participants receive set reward (VA canteen voucher) for each week of smoking cessation treatment they attend. The value of the reward will not change regardless of attendance at consecutive sessions.
12011235|NCT00508534|Drug|SB-751689|
12011236|NCT00508521|Device|Functional Electrical Stimulation|commercially available surface electrical stimulator
12011237|NCT00508521|Other|Standard Care|Standard care as ordered by their physician and covered by their insurance company.
12011238|NCT00508508|Behavioral|Interactive Voice Response System|Participants using IVR will receive training in peer communication techniques and participate in an initial nurse-led interactive group visit. They will then be asked to communicate at least weekly with their partner using the IVR system. The IVR system will also automatically send reminder calls to participants and allow them to leave voice mail messages for their partner and their care manager.
12011239|NCT00508508|Behavioral|Nurse-Led Group Clinic Visits|At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies.
12011240|NCT00508495|Drug|Paracetamol (acetaminophen)|Four 100 mL, 15 min IV infusions at six hour intervals
12011241|NCT00508495|Drug|Paracetamol 1% solution|Four 100 mL, 15 min IV infusions at six hour intervals
12011242|NCT00508495|Drug|0.9% sodium chloride solution|Four 100 mL, 15 min IV infusions at six hour intervals
12011243|NCT00508482|Other|deep needling|"Huatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain.
~Once a day, five times a week, four weeks."
12011244|NCT00508482|Drug|Lactulose|20-30ml, once a day before breakfast, for the whole study except the run-in period
12011245|NCT00508482|Other|shallow needling|Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.
12011246|NCT00508469|Drug|Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
12011247|NCT00508469|Drug|Travoprost 0.004% eye drops|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
12011248|NCT00508469|Drug|Timolol 0.05% eye drops|One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.
12011249|NCT00508469|Device|Travalert Dosing Aid|Approved device used with study medication to record time of instillation and quantify dosing
12011250|NCT00508456|Drug|Temodar (Temozolomide)|150 mg/m^2 orally once a day for 7 consecutive days (days 8 through 15).
12011251|NCT00508456|Dietary Supplement|Hominex-2|"Methionine free diet during Days 1 - 7 and Days 15 - 21 by consuming only shakes containing Hominex-2®."
12011252|NCT00508443|Radiation|Radiation Therapy|Three radiation treatments guided by the CT-on-Rails or Trilogy procedure over a period of 2 weeks. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.
12011253|NCT00508430|Drug|ASP8825|oral
12011254|NCT00508430|Drug|Placebo|oral
12011255|NCT00508404|Drug|Panitumumab|Administered by intravenous infusion
12011256|NCT00508404|Drug|FOLFIRI|FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m², leucovorin 400 mg/m², 5-fluorouracil bolus 400 mg/m², 5-fluorouracil infusion 2400 mg/m².
12011257|NCT00508391|Device|Optimized interventricular delay biventricular pacing|Lumax HF-T with optimized interventricular delay biventricular pacing
12011258|NCT00508378|Behavioral|Interview|Interview regarding side-effects of chemotherapy, 30-45 minutes.
12011259|NCT00508378|Behavioral|Questionnaire|Quality of life survey and symptom assessment questionnaire, 15 minutes.
12011260|NCT00508365|Drug|Carvedilol CR capsules|The carvedilol micropump (COREG) CR cpsules will be available with doses of 20 milligrams and 40 milligrams administered orally once daily.
12011261|NCT00508365|Drug|Placebo|Placebo capsules to match each dose level will be provided.
12011262|NCT00508365|Drug|Lisinopril|Lisinopril will be available as 10 milligrams tablets administered orally once daily.
12011263|NCT00508352|Procedure|Helical tomotherapy IMRT|Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
12011264|NCT00508339|Behavioral|Questionnaire|Toronto Extremity Salvage Score (TESS) questionnaire.
12011265|NCT00508326|Drug|Paclitaxel|Starting dose 150 mg/m^2 HAI once every 4 weeks
12011266|NCT00508313|Procedure|Thermal Imaging|Thermal imaging sessions, each taking approximately 10 minutes.
12011269|NCT00508287|Drug|BMS-686117|Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
12011270|NCT00508287|Drug|Byetta|Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
12011271|NCT00508287|Drug|Placebo|Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
12011272|NCT00508274|Drug|lapatinib in combination with capecitabine|daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000mg/m2/day on days1-14 every 21 days)
12011273|NCT00508261|Biological|Meningococcal vaccine GSK134612|Single dose intramuscular injection
12011274|NCT00508261|Biological|Infanrix™ hexa|Single dose intramuscular injection
12011275|NCT00508261|Biological|Meningitec™|Single dose intramuscular injection
12011276|NCT00508248|Dietary Supplement|omega 3 fatty acids|1g daily
12011277|NCT00508248|Dietary Supplement|placebo|olive oil capsule
12011278|NCT00508235|Behavioral|Questionnaire|Questionnaire about the patient's relationship with their best friend.
12011279|NCT00508222|Drug|Kaletra Tablets|Kaletra 800/200 OD
12011280|NCT00508209|Drug|bortezomib|1.3 mg/sqm days -5 and -2 in connection with high-dose melphalan (200mg/sqm day -2) and autologous stem cell support
12011281|NCT00508196|Other|RVP-min|DDD pacing with long AV delay
12011282|NCT00508196|Other|RVP-max|DDD pacing with short AV delay
12011283|NCT00508183|Procedure|single row|This method involves using a single row of anchor(s) to reattach the cuff to the bone.
12011284|NCT00508183|Procedure|double row fixation|"This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
12011285|NCT00508170|Behavioral|Questionnaire|The questionnaire contains 23 questions and is estimated to take approximately 10 minutes to complete.
12011286|NCT00508157|Drug|Aripiprazole|Tablets, Oral, 5 to 30 mg, once daily, 16 weeks
12011287|NCT00508157|Drug|Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)|Tablets, Oral, According to summary of product characteristics (SmPC)
12011288|NCT00508144|Drug|Alimta|500 mg/m^2 by vein Once Over 10 Minutes Every 3 Weeks
12011289|NCT00508131|Other|Whole Cows Milk|400 mL, administered as two 200 mL drinking episodes per day of either fortified or not fortified milk for 12 months.
12011290|NCT00508118|Drug|Nicardipine|on bypass
12011291|NCT00508118|Drug|0.9% saline|on bypass
12011292|NCT00508105|Procedure|subscapularis peel|"Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel."
12011293|NCT00508105|Procedure|osteotomy|This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
12011294|NCT00508092|Procedure|local anesthetic administration|"Pre incision skin infiltration with local anesthetic 0.5% bupivacaine by weight
~OR
~Pre incision skin infiltration and deeper field infiltration (deep to external oblique) with local anesthetic 0.5% bupivavcaine by weight"
12011295|NCT00508066|Drug|Bupivacaine|Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
12011296|NCT00508066|Drug|Normal Saline|Normal Saline, 4ml/hour for 72 hours.
12011297|NCT00508053|Procedure|Small stitches|
12011298|NCT00508053|Procedure|Mass closure|
12011299|NCT00508040|Drug|interferon alpha 2a|We propose to analyse the potential therapeutic effect of Interferon alpha2 a versus Steroid therapy with a control group for a 4 months period. This short period could not expose to a worsening of the disease because of the slow pathologic processus.
12011300|NCT00508040|Drug|prednisone|We propose to analyse the potential therapeutic effect of Interferon alpha2 a versus Steroid therapy with a control group for a 4 months period. This short period could not expose to a worsening of the disease because of the slow pathologic processus.
12011301|NCT00508027|Drug|Simvastatin|Comparison of 3 dosages of simvastatin given in a dose-escalating fashion. 20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days.
12011302|NCT00508014|Other|Usual Care|Usual Care with primary care provider during time period
12011303|NCT00508014|Behavioral|Concurrent Peer Review visit|Participants are offered an office visit with a peer of their clinician primary clinician. This office visit is structured and focused on blood pressure, diabetic, and/or lipid control with decision support available at point of care
12011304|NCT00508001|Drug|Vandetanib|ZD6474 300mg
12011305|NCT00508001|Drug|Vandetanib|ZD6474 100 mg
12011306|NCT00508001|Drug|Best Supportive Care|Placebo + Best Supportive Care
12011307|NCT00507988|Behavioral|Complex Problem Solving Training|10 sessions of 45 minutes complex problem solving training over 3 weeks (including 30 minutes of computerized planning and problem-solving training with Plan-A-Day and 15 minutes group session for transfer to everyday situations)
12011308|NCT00507988|Behavioral|Basic Cognitive Training|10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)
12011309|NCT00507975|Drug|nicotine versus placebo|The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
12011310|NCT00507962|Drug|Cisplatin|100 mg/m^2 Intraarterial On Day 1 Every 4 Weeks
12011311|NCT00507962|Drug|Liposomal Doxorubicin|Starting dose 20 mg/m^2 IV On Day 1 Every 4 Weeks
12011312|NCT00507949|Drug|Megestrol acetate|Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
12011313|NCT00507949|Drug|placebo|sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.
12011314|NCT00507936|Drug|ABT-894|ABT-894 1 mg capsule BID throughout treatment period
12011315|NCT00507936|Drug|ABT-894|ABT-894 2 mg capsule BID throughout treatment period
12011316|NCT00507936|Drug|ABT-894|ABT-894 4 mg capsule BID throughout treatment period
12011317|NCT00507936|Drug|placebo|placebo capsule BID throughout the treatment period
12011318|NCT00507936|Drug|Duloxetine|Duloxetine 60 mg QD throughout treatment period
12011319|NCT00507923|Device|Actigraph|Wear actigraph
12011320|NCT00507923|Other|Best Practice|Receive usual care
12011321|NCT00507923|Other|Quality-of-Life Assessment|Ancillary studies
12011322|NCT00507923|Other|Questionnaire Administration|Ancillary studies
12011324|NCT00507923|Other|Stretching|Participate in stretching sessions
12011325|NCT00507923|Procedure|Yoga|Participate in Tibetan yoga
12011326|NCT00507884|Procedure|3 Tesla MRI Scan|MRI of the kidneys and abdomen to be done within 15 days following the routine CT and lasting 1 - 2 hours.
12011327|NCT00507858|Drug|Pemetrexed|Starting dose of 500 mg/m^2 IV Once Over 10 Minutes Every 3 Weeks
12011328|NCT00507858|Drug|Dexamethasone|Arm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days
12011329|NCT00507845|Drug|Ramipril-Felodipine|Ramipril + felodipine 2.5/2.5mg per tablet. One tablet to be taken Od for 8 weeks (this dose could be increased at week 2 to 4 to 5 mg daily because of uncontrolled hypertension).
12011330|NCT00507832|Drug|Pimecrolimus|twice daily topical
12011331|NCT00507832|Drug|Hydrocortisone|twice daily topical
12011332|NCT00507832|Drug|Pimecrolimus|topical application as a cream twice daily
12011333|NCT00507819|Drug|Sildenafil|One 20 mg capsule of sildenafil will be taken by mouth three times-a-day.
12011334|NCT00507819|Drug|Placebo|One placebo capsule will be taken by mouth three times-a-day.
12011335|NCT00507806|Drug|perflutren lipid microsphere|
12011336|NCT00507793|Drug|Sirolimus|
12011337|NCT00507793|Drug|Cyclosporine|
12011338|NCT00507780|Drug|GnRH antagonist|
12011339|NCT00507767|Drug|dasatinib|Given PO or via PEG tube
12011340|NCT00507767|Procedure|pharmacological study|Correlative studies
12011341|NCT00507767|Procedure|laboratory biomarker analysis|Correlative studies
12011342|NCT00507754|Other|T-SPOT TB test|Extra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on forearm.
12011343|NCT00507741|Drug|Vintafolide|Part A: Induction Phase: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance Phase: vintafolide 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting. Part B: vintafolide 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting.
12011344|NCT00507741|Drug|Ertafolide|
12011345|NCT00507728|Drug|Bupropion|Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
12011346|NCT00507728|Drug|Varenicline|Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
12011347|NCT00507728|Drug|Placebo|Placebo by mouth for 12 weeks.
12011348|NCT00507728|Behavioral|Smoking Cessation Counseling|Counseling over 8 months and telephone support calls.
12011349|NCT00507715|Drug|Plantago ovata husk|5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days
12011350|NCT00507715|Other|hemicellulose crystalline|5g effervescent powder t.id. during 14 days
12011351|NCT00507702|Procedure|phlebotomy|Standard of care
12011352|NCT00507689|Drug|FTC/TDF|Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg was administered as a fixed-dose combination tablet orally once daily.
12011353|NCT00507689|Drug|Hepatitis B Immunoglobulin (HBIg)|HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol.
12011354|NCT00507663|Drug|Atenolol|Patients with a standing prescription for β-blockers will be continued on that medication. Pts not currently receiving a beta blocker will be given 50mg of atenolol on the morning of surgery, 50-100mg, twice per day, on the first postoperative day until postoperative day 7.
12011355|NCT00507650|Dietary Supplement|Fluid intervention|Volume of fluid prescribed by physician or provider/day X 5 days.
12011356|NCT00507650|Dietary Supplement|Fluid intervention plus 10 ml/kg/day|Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.
12011357|NCT00507637|Drug|NT 201|Injection of up to 50 Units NT 201 (incobotulinumtoxinA/Xeomin®) per eye and injection visit (8 injections visits in total).
12011358|NCT00507611|Procedure|Sentinel node mapping|Patients will undergo preoperative lymphoscintigraphy in the nuclear medicine department to access axillary and extra-axillary sites of localization. Intraoperatively, patients will also be injected with approximately 4 to 5 mL of 1% isosulfan blue dye (by intradermal, intraparenchymal, or subareolar route). Patients will undergo intraoperative identification and biopsy of all SLN candidates. A confirmatory axillary lymph node dissection will then be performed on all patients.
12011359|NCT00507598|Other|No intervention|Correlative study collecting serum and tissue samples
12011360|NCT00507585|Drug|Fluorouracil|300 mg/m^2 IV over 10 Minutes, then 600 mg/m^2 IV over 22 Hours repeated every 3 weeks (1 Cycle).
12011361|NCT00507585|Drug|Avastin|10 mg/m^2 IV Over 90 Minutes repeated every 3 weeks (1 Cycle).
12011362|NCT00507585|Drug|Leucovorin|200 mg/m^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).
12011363|NCT00507585|Drug|Oxaliplatin|60 mg/m^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).
12011364|NCT00507572|Other|Medical Chart Review|Medical records are reviewed
12011365|NCT00507559|Device|Aptus Endovascular AAA Repair System|EVAR (endovascular aneurysm repair)
12011366|NCT00507546|Drug|Ramelteon|8 mg nightly
12011367|NCT00507546|Drug|Placebo|Nightly 8mg of placebo (same appearance as ramelteon)
12011368|NCT00507533|Procedure|Continuous positive airway pressure|
12011369|NCT00507520|Procedure|Full dose almonds|
12011370|NCT00507520|Procedure|Half dose almonds+half dose muffin|
12011371|NCT00507520|Procedure|Full dose whole wheat muffin|
12011372|NCT00507507|Drug|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablet taken orally once daily
12011373|NCT00507507|Drug|FTC|Emtricitabine (FTC) 200 mg capsule taken orally once daily
12011374|NCT00507507|Drug|Placebo|Placebo to match FTC taken once daily
12011375|NCT00507494|Drug|pioglitazone|Pioglitazone 30 mg o.d. tablet for 12 weeks or placebo o.d. tablet for 12 weeks in random order. After 12 wk treatment there is a 4 wk washout out which is followed by switch of study medication in a cross over fashion and a further 12 wk treatment.
12011486|NCT00506714|Device|single point cane|Adjustable single point cane with SureGrip handle
12011376|NCT00507468|Procedure|Transendocaridal Transplantation of Autologous Bone Marrow|Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.
12011377|NCT00507455|Drug|solifenacin succinate|Solifenacin succinate tablets
12011378|NCT00507455|Drug|tamsulosin hydrochloride|Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
12011379|NCT00507455|Drug|Placebo to solifenacin|
12011380|NCT00507455|Drug|Placebo to tamsulosin|
12011381|NCT00507442|Drug|VELCADE (bortezomib)|bortezomib 1.3 mg/m^2 given via IV on days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on days 1, 8, 15 and 22 of a 6-week cycle for 4 cycles (maintenance).
12011382|NCT00507442|Drug|dexamethasone|dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop
12011383|NCT00507442|Drug|cyclophosphamide|cyclophosphamide 500 mg/m^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop
12011384|NCT00507442|Drug|Revlimid (lenalidomide)|"lenalidomide 25 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDR arm)
~lenalidomide 15 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDCR arm)"
12011385|NCT00507429|Drug|CA4P|CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
12011386|NCT00507429|Drug|paclitaxel|200mg/m squared on Day 1
12011387|NCT00507429|Drug|carboplatin|6 AUC on Day 1 following paclitaxel
12011388|NCT00507416|Drug|Bortezomib|Bortezomib bolus intravenous (IV) injection
12011389|NCT00507416|Drug|Dexamethasone|Dexamethasone for oral administration
12011390|NCT00507416|Drug|Melphalan|Melphalan for oral administration
12011391|NCT00507416|Drug|Prednisone|Prednisone for oral administration
12011392|NCT00507416|Drug|Thalidomide|Thalidomide for oral administration
12011393|NCT00507403|Drug|infliximab|
12011394|NCT00507390|Dietary Supplement|n-3 polyunsaturated fatty acids (PUFAs)|2g n-3 PUFAs once daily for 8 weeks
12011395|NCT00507390|Dietary Supplement|olive oil|1 capsule day
12011396|NCT00507364|Drug|Local injection of activated macrophages to anal fissure|
12011397|NCT00507351|Behavioral|Questionnaire|3 questionnaires that will take 20 minutes total to complete.
12011398|NCT00507338|Procedure|PCI|early PCI for NSTEMI; primary PCI for STEMI
12011399|NCT00507325|Procedure|Blood Sample|Blood samples will be collected.
12011400|NCT00507325|Procedure|Tumor Sample|Tumor samples will be collected using a small needle, a punch knife, or a small surgery.
12011401|NCT00507312|Device|HD medical device (ViScope)|Device
12011402|NCT00507312|Device|CSIRO device|device
12011403|NCT00507299|Behavioral|Enhanced pediatric primary care|Residents received special training to address targeted psychosocial problems. Parents bringing in children (0 - 5 years) completed a screening questionnaire and gave this to their doctor. The resident briefly assessed the identified problems and helped address them. A social worker was present to assist.
12011404|NCT00507299|Behavioral|Standard pediatric primary care|Residents did not receive special training on the targeted psychosocial problems. They did not use the parent screening questionnaire, and they did not have a dedicated social worker.
12011405|NCT00507286|Drug|combination of various doses of sildenefil and alprostadil|
12011406|NCT00507273|Other|GIST Registry|Internet based data registry about how different physicians treat and manage patients with gastrointestinal stromal tumors.
12011407|NCT00507260|Behavioral|Food Record|A record of the amount and kind of food and drink you intake will be completed.
12011408|NCT00507260|Other|Nutritional Consults|Meeting with a dietician consultant regarding issues related to food intake. Participants will also receive the results from the food records.
12011409|NCT00507247|Drug|Daptomycin|6mg/kg/day IV for at least 10 days.
12011410|NCT00507234|Drug|formoterol fumarate inhalation solution|
12011411|NCT00507221|Drug|Albendazole|"Every 3 months for 24 months (enrollment 3, 6, 9, 12, 15, 18, 21, and 24 months):
~400mg/day X 3 days"
12011412|NCT00507221|Drug|Praziquantel|At enrollment and 12 months: 25mg/kg X 1
12011413|NCT00507221|Drug|Current standard of care in Kenya|Current standard of care for HIV patients in Kenya based on WHO guidelines.
12011414|NCT00507208|Device|Dynasplint Trismus System|The Dynasplint System will be used for 6 months.
12011415|NCT00507208|Other|Tongue Depressors|Tongue depressors to be used for 3 months at which time mouth opening will be measured. If there is no change then the patient will crossover to the Dynasplint Trismus System for another 3 months.
12011416|NCT00507195|Drug|Hypnotics: propofol, sevoflurane, desflurane,desflurane,midazolam|
12011417|NCT00507182|Procedure|Fluorescence Spectroscopy|1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.
12011418|NCT00507169|Drug|SVT-40776|
12011419|NCT00507156|Procedure|Standard primary PCI|Acute re-opening of the occluded coronary artery
12011420|NCT00507156|Procedure|Mechanical postconditioning|Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
12011421|NCT00507143|Drug|irinotecan|
12011422|NCT00507130|Biological|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
12011423|NCT00507130|Biological|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
12011424|NCT00507130|Biological|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
12011425|NCT00507130|Other|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
12011426|NCT00507117|Drug|Lunesta|Lunesta 3mg prior to PSG
12011427|NCT00507117|Drug|Placebo control|matching placebo
12011428|NCT00507091|Drug|ZD6474 (vandetanib) 100mg|once daily oral tablet
12011429|NCT00507091|Drug|Irinotecan|intravenous infusion
12011430|NCT00507091|Drug|5-Fluorouracil|intravenous infusion
12011431|NCT00507091|Drug|Leucovorin|intravenous infusion
12011432|NCT00507091|Drug|ZD6474 (vandetanib) 300mg|once daily oral tablet
12011433|NCT00507078|Procedure|Surgical treatment for OSA|
12011434|NCT00507065|Drug|Mixed salts of a single-entity amphetamine (ADDERALL XR)|
12011435|NCT00507065|Drug|Placebo|
12011436|NCT00507052|Drug|N-acetylcysteine|
12011437|NCT00507039|Procedure|inhalative grass-pollen provocation|Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In subjects, who develop a fall in FEV1 of more than 20%, this will be followed by two single-step challenges.
12011438|NCT00507026|Drug|IV Diclofenac|IV Diclofenac q6h
12011439|NCT00507026|Drug|IV ketorolac|IV ketorolac q6h
12011440|NCT00507026|Drug|Placebo|Placebo q6h
12011441|NCT00507013|Device|QuickClose device|
12011442|NCT00507000|Drug|Cholecalciferol|Drug: Cholecalciferol Drug: Cholecalciferol 60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate for first two months followed by 1 gm of elemental calcium in form of calcium carbonate daily cholecalciferol (vitamin D)60,000 IU per month for the next four months Arms: A, Cholecalciferol
12011443|NCT00507000|Drug|Lactose granules|Drug: Lactose placebo Lactose placebo granules in identical sachet given weekly and two lactose tablets for first two months followed one sachet of placebo granules every month and two tablets of lactose containing placebo tablets taken daily for next four months
12011444|NCT00506987|Drug|SCH 486757|SCH 486757 2 x 50-mg capsule twice daily orally for 2 weeks followed by a 2-week washout period and 2 weeks of crossover treatment
12011445|NCT00506987|Drug|Placebo Dose 1|Matching placebo capsules twice daily orally for 2 weeks followed by a 2 week washout period and 2 weeks of crossover treatment
12011446|NCT00506974|Drug|sodium oxybate|3.5 g of sodium oxybate or placebo on two of the five overnights.
12011447|NCT00506961|Drug|Rosuvastatin|10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
12011448|NCT00506961|Drug|Simvastatin|20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
12011449|NCT00506948|Drug|Mycophenolate Mofetil (MMF)|15 mg/kg by vein or by mouth every 12 hours.
12011450|NCT00506948|Drug|Thymoglobulin|1.5 mg/kg by vein daily for 4 days
12011451|NCT00506948|Drug|Sirolimus|6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day.
12011452|NCT00506948|Procedure|Stem Cell Transplant|Stem cell infusion on Day 0.
12011453|NCT00506935|Drug|GVG|5 grams GVG
12011454|NCT00506935|Drug|placebo|placebo
12011455|NCT00506922|Drug|Pentostatin|"Given intravenously on days +8, +15, +22 and +30 post transplant:
~Group 2 - Pentostatin 0.5 mg/m^2
~Group 3 - Pentostatin 1 mg/m^2
~Group 4 - Pentostatin 1.5 mg/m^2
~Group 5 - Pentostatin 2 mg/m^2"
12011456|NCT00506922|Drug|Tacrolimus|Given intravenously from day -2, and will be switched to oral dosing when tolerated.
12011457|NCT00506922|Drug|Methotrexate|Given intravenously on days +1, +3, and +6 at the dose of 5 mg/m2.
12011458|NCT00506909|Drug|Oxytocin|20 IU BID or 40 IU BID
12011459|NCT00506909|Drug|Placebo|20 IU BID or 40 IU BID
12011460|NCT00506896|Drug|intraarticular injection|Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration
12011461|NCT00506883|Drug|High Dose Colchicine (4.8 mg total dose)|At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total of six additional doses (total colchicine dose 4.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.
12011462|NCT00506883|Drug|Low Dose Colchicine (1.8mg total dose)|At randomization, patients were given an identical looking blister pack containing (3) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules and five placebo capsules. Patients were instructed to take 2 capsules initially (0.6 mg x 2) followed by an additional capsule every hour for a total of six additional doses (one active (0.6 mg) and 5 placebo capsules), a total colchicine dose = 1.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center
12011463|NCT00506883|Other|Placebo Control|At randomization, patients were given an identical looking blister pack containing (8) placebo capsules identical in appearance to the study drug. Patients were instructed to take 2 capsules initially followed by an additional capsule every hour for a total of six additional doses beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.
12011464|NCT00506870|Device|INRatio / Coaguchek XS|INR measured by patient himself using INRation or Coaguchek device. And one follow-up of INR per month, measured in laboratory.
12011465|NCT00506870|Device|Conventional follow-up of anti-coagulation|At least, one follow-up of INR per month. Measured in laboratory.
12011466|NCT00506857|Drug|Busulfan|Starting Dose 0.8 mg/kg by vein every 6 hours x 12 doses.
12011467|NCT00506857|Drug|Fludarabine|30 mg/m^2 by vein daily x 4 days.
12011468|NCT00506844|Drug|Cetuximab, Irinotecan, Capecitabine|
12011469|NCT00506831|Drug|Imatinib mesylate|100 mg orally daily increased by 100 mg/day every 2 weeks to maximum of 400 mg daily as tolerated. Treatment for 6 months total.
12011470|NCT00506818|Other|Multifactorial vascular-risk-factor-intervention|
12011471|NCT00506805|Drug|SNX-5422|dose escalated, tablets every other day; undetermined duration until disease progression
12011472|NCT00506792|Drug|QAU145|
12011473|NCT00506792|Drug|Placebo|
12011474|NCT00506779|Drug|Imatinib Mesylate|Phase I = Maximum tolerated dose (MTD) derived from dose escalation of 400, 500, 600 mg by mouth daily
12011475|NCT00506779|Drug|Paclitaxel|175 mg/m^2 by vein over 3 Hours every 21 Days
12011476|NCT00506766|Behavioral|Bladder Health Class consisting of 6 weekly group sessions|1 time
12011477|NCT00506766|Behavioral|Practice PFMT and BT|As needed for 4 years
12011478|NCT00506766|Behavioral|Clinic examination for pelvic muscle function|1/year for 4 years
12011479|NCT00506766|Behavioral|Record keeping in 3-day voiding diary|Every 6 months for 4 years
12011480|NCT00506753|Behavioral|MI/CBT|Motivational Interviewing followed by Cognitive Behavior Therapy
12011481|NCT00506753|Behavioral|RT/SU|Relaxation Training followed by Treatment as Usual
12011482|NCT00506740|Device|Ultrasonic scalpel|A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
12011483|NCT00506740|Device|monopolar electrosurgery generator and tip|
12011484|NCT00506727|Drug|Mixed amphetamine salts (ADDERALL XR)|
12011485|NCT00506727|Drug|Atomoxetine hydrochloride|
12011487|NCT00506701|Drug|Tadalafil|40 mg tablet
12011488|NCT00506688|Drug|reduced glutathione sodium salt|646 mg GSH-Na powder per vial to prepare a 4ml solution, twice daily for 24 weeks.
12011489|NCT00506688|Drug|0.9% normal saline (control)|4 ml of a 0.9% normal saline solution (9mg/ml NaCl), twice daily for 24 weeks.
12011490|NCT00506675|Device|Patching|42 hours per week of patching
12011491|NCT00506675|Drug|Atropine|daily atropine (1%)
12011492|NCT00506675|Device|Patching|two hours of daily patching for 4 weeks, then no treatment
12011493|NCT00506675|Drug|Atropine|once weekly atropine for 4 weeks, then no treatment
12011494|NCT00506662|Drug|insulin detemir|Treat-to-target, s.c. (under the skin) injection, once daily
12011495|NCT00506662|Drug|insulin NPH|Treat-to-target, s.c. (under the skin) injection, once daily
12011496|NCT00506649|Other|protocol|management protocols of non-pharmacological strategies and individualized titration of analgesics, sedatives, and anti-psychotics based on observed scores to manage sedation, analgesia and delirium.
12011497|NCT00506636|Behavioral|Tissue engineering for hair follicle regeneration|
12011498|NCT00506623|Drug|Capecitabine, Irinotecan|
12011499|NCT00506610|Drug|T-62|
12011500|NCT00506597|Drug|Erwinase|If allergic to E.Coli Asparaginase = 1 Dose (20,000 Units/m^2) Daily; If allergic to Pegylated Asparaginase = 6 Doses (25,000 Units/m^2) Daily Every Other Day. Received as an injection through a needle in vein, under the skin, or in muscle.
12011501|NCT00506584|Dietary Supplement|Pasteurized human milk and pasteurized human milk fortifier|Human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day
12011502|NCT00506584|Dietary Supplement|Pasteurized human milk and pasteurized human milk fortifier|Human milk fortifier is initiated when nutrition volume reaches 40 mL/kg/day
12011503|NCT00506584|Dietary Supplement|Human milk fortifier (bovine-based), pre-term formula|Bovine-based human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day
12011504|NCT00506584|Dietary Supplement|Pasteurized human milk and pasteurized human milk fortifier|Human milk fortifier initiated when nutrition volume reaches 100 mL/kg/day
12011505|NCT00506584|Dietary Supplement|Pre-term/term formula|Bovine milk-derived nutrition formulated for very low birth weight infants
12011506|NCT00506571|Drug|S-1, irinotecan, oxaliplatin|
12011507|NCT00506558|Procedure|Ventral Surgical Decompression with Instrumented Fusion|Multi-level discectomy or Corpectomy are performed at surgeon's discretion. After decompression an instrumented fusion is performed.
12011508|NCT00506558|Procedure|Dorsal Decompression With or Without Fusion|Dorsal decompressive laminectomy, laminoplasty, or laminectomy with lateral mass instrumented fusion
12011509|NCT00506545|Drug|SCH 619734|SCH 619734 50-mg capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.
12011510|NCT00506545|Drug|Placebo Dose 1|Matching placebo capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.
12011511|NCT00506532|Drug|Surfactant (calfactant)|
12011512|NCT00506519|Drug|antithrombin alfa (INN name)|
12011513|NCT00506506|Drug|N-acetylcysteine|N-acetylcysteine 1200 mg twice daily x 48 hours
12011514|NCT00506506|Drug|Placebo|
12011515|NCT00506493|Device|Cardioblate Surgical Ablation System|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
12011516|NCT00506493|Procedure|Surgical RF Ablation|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
12011517|NCT00506480|Procedure|endometrial sampling|Endometrial biopsy is a procedure in which a tissue sample is obtained from the endometrium. This procedure is performed without anesthesia during pelvic examination. The cervix is cleaned with an antiseptic solution and then grasped with an instrument (tenaculum) to steady the uterus. A small, hollow plastic tube is gently passed into the uterine cavity. Gentle suction removes a sample of the lining. The tissue sample and instruments are removed, and the sample is examined by pathology, immunohistochemistry, PCR and western blotting.
12011518|NCT00506467|Procedure|Vibration Response Imaging|Lung function test performed using the VRI system immediately before or after the standard lung function test.
12011519|NCT00506454|Drug|Lipidose|Over the course of 2 weeks, immediately following subject's three (Monday/Wednesday/Friday (M/W/F)) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of Lipidose over a 2-hour period.
12011520|NCT00506454|Drug|Placebo|Over the course of 2 weeks, immediately following subject's three (M/W/F) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of placebo over a 2-hour period.
12011521|NCT00506441|Drug|MCI-196|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
12011522|NCT00506441|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
12011523|NCT00506428|Behavioral|chronic sleep restriction|5.6 hours of sleep per 24 hours for 3 weeks
12011524|NCT00506415|Drug|Rivastigmine 5 cm^2|5 cm^2 transdermal patch
12011525|NCT00506415|Drug|Rivastigmine 10 cm^2|10 cm^2 transdermal patch.
12011526|NCT00506415|Drug|Rivastigmine 15 cm^2|15 cm^2 transdermal patch.
12011527|NCT00506415|Drug|Placebo to 15 cm^2 patch|Placebo of rivastigmine transdermal patch 15 cm^2.
12011528|NCT00506415|Drug|Placebo to 10 cm^2 patch|Placebo of rivastigmine transdermal patch 10 cm^2.
12011529|NCT00506402|Drug|MKC-1|Capsule, 30 mg and 100 mg, BID, continuous dosing
12011571|NCT00506077|Drug|Comparator: Placebo (unspecified)|MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.
12011572|NCT00506064|Drug|Melatonin|0.15 mg/kg by mouth (PO) Daily
12012011|NCT00502996|Drug|Methotrexate|>=15 mg po/week
12011530|NCT00506389|Drug|Esmirtazapine|Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name corn starch), magnesium stearate, and lactose monohydrate.
12011531|NCT00506389|Drug|Placebo|The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.
12011532|NCT00506376|Behavioral|Interview|Interview that will take about 20 minutes to complete.
12011533|NCT00506363|Procedure|pulsed dye laser therapy|Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.
12011534|NCT00506350|Biological|Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose|A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
12011535|NCT00506350|Biological|Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses|Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
12011536|NCT00506337|Drug|Qingyi granules|"Control group: The therapeutic methods accord to the concert schemes cited in the Guides to diagnosis and treatment of severe acute pancreatitis introduced by the Pancreatic Surgery Group of Surgical Chapter of Chinese Medical Association.
~Treatment group: In addition to the concert schemes cited in the Guides to diagnosis and treatment of severe acute pancreatitis, during the first stage of the disease herbal Qingyi granules 1-B 4 bags dissolved in water 200ml were administered through the gastric tube q6h. Then the gastric tube was closed for 1h, and Qingyi granules 1-B another 4 bags dissolved in water 400ml were given through enema q6h. During the second stage (from the 2nd week to the 4th week after onset) Qingyi granules 2-B 2bags dissolved in water 200ml were added QD."
12011537|NCT00506311|Drug|Fibrin Sealant|Tisseel applied externally to the dissected groin area.
12011538|NCT00506298|Drug|bezafibrate + diflunisal|bezafibrate + diflunisal
12011539|NCT00506298|Drug|bezafibrate + placebo|bezafibrate + placebo
12011540|NCT00506285|Drug|Methylphenidate Transdermal System (MTS)|MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH.
12011541|NCT00506285|Other|placebo patch|This patch is designed to appear identical to the actual intervention patch
12011542|NCT00506272|Procedure|Self blood glucose monitoring and insulin administration|Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin
12011543|NCT00506272|Procedure|Standard care|finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff
12011544|NCT00506259|Drug|dTR Melatonin (NIH CC PDS)|
12011545|NCT00506259|Device|Phototherapy (Bright Light)|
12011546|NCT00506259|Drug|Melatonin CR|
12011547|NCT00506246|Drug|Propofol|"intravenous (total intravenous anaesthesia)
~induction and maintenance"
12011548|NCT00506233|Behavioral|Questionnaire|Completion of questionnaires at 3 different times (when joining this study, 3 months later, and 6 months later). Each should take about 20-30 minutes to complete.
12011549|NCT00506207|Drug|S-1, Irinotecan, Oxaliplatin|
12011550|NCT00506194|Drug|Insulin|
12011551|NCT00506194|Drug|OAD|Gliclazide-MR, Metformin, Glimepiride
12011552|NCT00506181|Drug|probiotic mixture|"Jarro-Dophilus probiotic mixture (4,400,000,000 bacteria in each capsule). One capsule X2/day."
12011553|NCT00506181|Drug|Placebo|
12011554|NCT00506168|Drug|Irinotecan, Capecitabine|
12011555|NCT00506155|Drug|Avastin|10 mg/kg by vein over 90 minutes
12011556|NCT00506155|Drug|Cisplatin|70 mg/m^2 by vein over 4 hours
12011557|NCT00506155|Drug|Doxorubicin|30 mg/m^2 by vein over 15 minutes
12011558|NCT00506155|Drug|Methotrexate|30 mg/m^2 by vein over 30 minutes
12011559|NCT00506155|Drug|Vinblastine Sulfate|3 mg/m^2 by vein over 30 minutes
12011560|NCT00506142|Drug|Marqibo® (vincristine sulfate liposomes injection)|"Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
12011561|NCT00506129|Drug|Fludarabine|25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.
12011562|NCT00506129|Drug|Melphalan|70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.
12011563|NCT00506129|Procedure|Allogeneic Transplant|Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.
12011564|NCT00506129|Drug|Thymoglobulin|2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
12011565|NCT00506116|Behavioral|Videotape, routine care, PME instruction|A 40 minute videotape about non-directed, spontaneous pushing and/or a videotape of antenatal perineal massage and pelvic muscle exerise (PME) at intake visit. The control women received routine care and PME instruction at intake visit.
12011566|NCT00506116|Behavioral|PME practice and record keeping (in diaries)|
12011567|NCT00506116|Behavioral|Non-directed or directed,spontaneous or sustained pushing|Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.
12011568|NCT00506116|Procedure|Data collection|Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum
12011569|NCT00506090|Procedure|pulsed dye laser therapy|Treatment will begin on the day of suture removal. Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device at 3 weeks intervals for 6 sessions. Another part will be treated with pulsed dye laser and dynamic cooling device at 6 weeks intervals for 6 sessions. Only dynamic cooling device will be used for remaining part serving as control.
12011570|NCT00506077|Drug|MK0249|MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.
12011573|NCT00506064|Drug|Placebo|Two, three, or four starch tablet or capsules before bed
12011574|NCT00506064|Behavioral|Questionnaire|Sleep study surveys, two per day completed each evening, lasting 10 minutes
12011575|NCT00506051|Drug|ZD6474 (vandetanib) 100mg|once daily oral tablet
12011576|NCT00506051|Drug|pemetrexed|intravenous infusion
12011577|NCT00506051|Drug|ZD6474 (vandetanib) 300mg|
12011578|NCT00506038|Procedure|fine needle technique|
12011579|NCT00506025|Dietary Supplement|Cranberry Juice|Low-calorie, Low-carbohydrate content 8 oz dose of Cranberry juice
12011580|NCT00506025|Dietary Supplement|De-Activated Cranberry juice|De-Activated Cranberry juice in the am, then placebo (P) in the pm
12011581|NCT00506012|Drug|T2000|T2000 at doses of 200 mg a day to 1000 mg a day
12011582|NCT00505999|Behavioral|Questionnaire|Questionnaire taking 30-40 minutes to complete.
12011583|NCT00505986|Procedure|endometrial biopsy|
12011584|NCT00505973|Drug|SCA-136|
12011585|NCT00505960|Behavioral|Diabetes Care for Korean Americans|Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.
12011586|NCT00505947|Drug|infliximab|infliximab 5 mg/Kg body weight by intravenous infusion
12011587|NCT00505947|Drug|placebo|placebo 5 mg/Kg body weight by intravenous infusion
12011588|NCT00505934|Drug|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
12011589|NCT00505921|Drug|Campath-1H|3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.
12011590|NCT00505921|Drug|G-CSF|10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.
12011591|NCT00505921|Drug|GM-CSF|250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.
12011592|NCT00505921|Drug|BCNU|300 mg/m2 IV over 1 hour on day -6
12011593|NCT00505921|Drug|Stem Cell Transplant|Stem cell infusion on Day 0.
12011594|NCT00505921|Drug|Preparative Regimen for Allogenic Stem Cell Transplantation|Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0.
12011595|NCT00505921|Drug|Cytarabine|200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),
12011596|NCT00505921|Drug|Etoposide|200 mg/m2 IV twice on day -5 to -2 (total 8 doses)
12011597|NCT00505921|Drug|Melphalan|140 mg/m2 IV on day -1.
12011598|NCT00505921|Drug|Campath|15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation
12011599|NCT00505921|Drug|Fludarabine|30 mg/m2 IV/day (days -6 to -4)
12011600|NCT00505921|Drug|Cyclophosphamide|750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).
12011601|NCT00505921|Radiation|Low dose total body irradiation|Low dose total body irradiation of 2 Gy day 0.
12011602|NCT00505895|Drug|Melphalan|Arm 1 = 140 mg/m^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m^2 intravenous over 20 Minutes on Day -1.
12011603|NCT00505895|Drug|Fludarabine|30 mg/m^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).
12011604|NCT00505895|Procedure|Stem Cell Infusion|Stem Cell Infusion on Day 0.
12011605|NCT00505895|Drug|Rituximab|375 mg/m^2 intravenous on Day -5, +2 +9 and +16.
12011606|NCT00505882|Drug|Pramlintide|Pramlintide will be started at 15 mcg (2.5 units) subcutaneously immediately prior to major meals and it will be increased by 15mcg every 3 days as tolerated (i.e. nausea, vomiting, upset stomach) to a maximum dose of 60 mcg (10 units) before meals. If significant nausea persists at 45 or 60 mcg level, the dose should be decreased to 30 mcg (5 units) before meals. If the 30 mcg dose is not tolerated, investigator will evaluate for possibility of withdrawing the pramlintide. The dose of preprandial short acting insulin (eg: Novolog/Humalog) will be reduced by 30 to 50% at the start of pramlintide 15 mcg (2.5 units) and then will be adjusted every time the dose of pramlintide is increased by 15 mcg (2.5 units) as needed based on blood glucose readings.
12011607|NCT00505882|Drug|Glargine|
12011608|NCT00505882|Drug|Lispro|
12011609|NCT00505882|Drug|Aspart|
12011610|NCT00505869|Behavioral|Health & Wellness Intervention|Counseling focusing on health concerns related to pregnancy, information about smoking and pregnancy, tips for quitting, and problem-solving skills to manage situations that might be triggers for smoking.
12011611|NCT00505869|Behavioral|Questionnaire|Questionnaires about mood, confidence in quitting, smoking behavior, and social support.
12011612|NCT00505869|Behavioral|Mood Management Intervention|Counseling focusing on learning to manage negative moods (depressed mood, tension, anxiety), as well as providing tips for quitting smoking, problem-solving skills, and information about smoking and pregnancy.
12011613|NCT00505843|Drug|MK0657|7mg MK0657 capsules
12011614|NCT00505843|Drug|Comparator: Placebo (unspecified)|7mg MK0657 Pbo capsules
12011615|NCT00505843|Drug|Comparator: levodopa|levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
12011616|NCT00505843|Drug|Comparator: carbidopa|carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.
12011617|NCT00505830|Other|questionnaires|"Primary outcome:
~Autism Spectrum Quotient (AQ)
~Secondary outcome measure:
~Empathy quotient (EQ) Systemizing quotient (SQ) WISC III or WISC IV ADOS score ADI score"
12011618|NCT00505817|Drug|Cetrorelix and Leuprolide|
12011619|NCT00505804|Drug|dexmedetomidine|Dexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician.
12011620|NCT00505804|Drug|haloperidol|Haloperidol IV loading dose of 2.5mg, followed by a continuous infusion of 0.0 to 2mg/hr for as long as deemed necessary by the treating clinician
12011664|NCT00505505|Drug|Insulin (Actrapid)|50 UI Actrapid diluted in 50 ml of saline
12011665|NCT00505492|Drug|Carboplatin|AUC 5 by vein once every 28 Days
12011621|NCT00505791|Drug|Nesiritide|Study drug will be administered for 24 hours. Study drug will be initiated with a 2-µg/kg loading bolus followed by .01-µg/kg/min infusion. This may be increased at a rate of .005-µg/kg/min. every 3 hours until maximum dose of .03-µg/kg/min. Any increase in the infusion rate will be preceded by a 1-µg/kg bolus and increases in infusion rates will be permitted only in patients who have a systolic blood pressure > 100 mmHg.
12011622|NCT00505778|Drug|Mesalamine Once-Daily|Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
12011623|NCT00505778|Drug|Mesalamine Twice-Daily|Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
12011624|NCT00505765|Drug|AL-108|AL-108, 5 mg/day- one spray in each nostril once per day
12011625|NCT00505765|Drug|AL-108|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
12011626|NCT00505765|Drug|Placebo|Placebo- 3 sprays in each nostril, twice per day
12011627|NCT00505765|Drug|Placebo|Placebo- one spray in each nostril, once per day
12011628|NCT00505752|Drug|AS900672-Enriched 50 microgram (mcg)|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.
12011629|NCT00505752|Drug|AS900672-Enriched 100 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.
12011630|NCT00505752|Drug|AS900672-Enriched 150 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.
12011631|NCT00505752|Drug|Follitropin alfa 150 international unit (IU)|Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.
12011632|NCT00505752|Drug|Recombinant human chorionic gonadotropin (r-hCG)|Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels will approximately 150 picogram per milliliter [pg/mL] per mature follicle).
12011633|NCT00505739|Drug|Mifepristone|200 mg by mouth (PO) Daily x 4 Weeks
12011634|NCT00505726|Procedure|Reflectance Confocal Imaging|Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.
12011635|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu two times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity
12011636|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011637|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 3 x 10e11 cfu i.w. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011638|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 4 x 10e 11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011639|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 2 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011640|NCT00505700|Drug|velcade|
12011641|NCT00505700|Drug|Idarubicin|
12011642|NCT00505700|Drug|Cytarabine|
12011643|NCT00505687|Drug|Rotigotine|"Rotigotine transdermal patches:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
~Optimal dosing:
~The maximum rotigotine dose allowed is 16 mg/24 hours."
12011644|NCT00505661|Drug|Letrozole|2.5 mg PO Once Daily
12011645|NCT00505648|Drug|Tegeline®|2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.
12011646|NCT00505635|Drug|Temozolomide|250 mg/m^2 By Mouth Every 4 Hours x 3 Doses On Day 1
12011647|NCT00505635|Drug|Velban|1.5 mg/m^2 By Vein Over 15-30 Minutes On Days 1-4
12011648|NCT00505635|Drug|Cisplatin|20 mg/m^2 By Vein Over 45-120 Minutes On Days 1-4
12011649|NCT00505635|Drug|Interleukin-2|9 MIU/m^2 By Vein Over 24 Hours x 4 Doses On Days 1-4
12011650|NCT00505635|Drug|Intron-A|5 mu/m^2 Subcutaneously (Under the skin) Daily On Days 1-5
12011651|NCT00505635|Drug|Thalidomide|400 mg By Mouth Daily
12011652|NCT00505622|Drug|Perampanel|
12011653|NCT00505609|Behavioral|Standard Days Method|The Standard Days Method is a fertility awareness-based method of family planning. Users avoid unprotected intercourse during cycle days 8 to 19. Study participants were for up to 13 cycles of method use.
12011654|NCT00505596|Behavioral|Informed free choice|Women will be instructed to view an updated prenatal testing decision aid and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study
12011655|NCT00505583|Drug|MOA-728|
12011656|NCT00505570|Device|AMPLATZER® PFO Occluder Device|PFO device closure
12011657|NCT00505557|Procedure|Transaxillary dual plane technique|
12011658|NCT00505544|Behavioral|Questionnaire|Questionnaires that ask about your sleep, symptoms, and mood.
12011659|NCT00505544|Device|Actigraph|Wear actigraph to collect information on activity levels and sleep patterns for one week.
12011660|NCT00505531|Drug|Tramadol Extended Release Oral Capsule|Tramadol ER- up to either 200 mg or 300 mg based on randomization
12011661|NCT00505531|Drug|Benadryl|Placebo group will take up to 25 mg of Benadryl
12011662|NCT00505518|Drug|Psychotropic medication (at discretion of psychiatrist)|Antidepressant medication, prescribed at discretion of psychiatrist
12011663|NCT00505518|Behavioral|Collaborative psychiatric and primary medical care|Regular care visits from health workers
12011666|NCT00505492|Drug|Cisplatin|40 mg/m^2 by vein (IV) Weekly Over 4 Hours
12011667|NCT00505492|Drug|Paclitaxel|135 mg/m^2 by vein (IV) Once Every 28 Days
12011668|NCT00505466|Behavioral|Genetic Counseling|Genetic counseling conducted in person, by telephone with an M. D. Anderson Genetic Counselor, or with a local Genetic Counselor in conference with the M. D. Anderson Genetic Counselor.
12011669|NCT00505453|Biological|Fluviral®|
12011670|NCT00505440|Behavioral|Telephone case management and motivational interviewing|'Telephone case management and motivational interviewing': Immediate screening results are given to the physician during the patient's visit. Telephone case management and motivational interviewing (MI) at 1, 6, and 9 weeks to enhance engagement and commitment to change
12011671|NCT00505440|Behavioral|Usual care|Usual care with mailed screening results
12011672|NCT00505427|Dietary Supplement|Alpha Lipoic Acid|
12011673|NCT00505414|Drug|Tapentadol in the Titration Phase|
12011674|NCT00505414|Drug|Morphine in the Maintenance Phase|"Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted. In the maintenance phase participants continued on the dose level established in titration phase.
~Participants randomized to the morphine arm remained on morphine if they qualified for the maintenance phase of the study. The participants were maintained on the dose established at the end of the titration phase. The adverse events listed were documented in the maintenance phase."
12011675|NCT00505414|Drug|Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase|Participant randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
12011676|NCT00505414|Drug|Tapentadol in the Maintenance Phase|The participants re-randomized to receive tapentadol prolonged release in the maintenance phase were maintained on the dose established in the titration phase.
12011677|NCT00505414|Drug|Morphine in the Titration Phase|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses). Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted.
12011678|NCT00505401|Biological|recombinant HIV-1 Tat protein|
12011679|NCT00505375|Drug|CTLA-4 Ig|Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
12011680|NCT00505375|Other|Placebo|Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
12011681|NCT00505362|Procedure|Rectus closure|Reapproximation of the rectus muscles with three-interrupted sutures
12011682|NCT00505349|Behavioral|Computer-based cognitive training|The experimental cognitive training program consists of interactive training exercises in which the participant responds to visual patterns and stimuli. The program is designed upon the principles of brain-plasticity, and, for the purposes of this study, is intended to be used for an 8-10 week period (40 total hours of training.)
12011683|NCT00505336|Drug|Eplerenone|oral Eplerenone titrated to 50mg for duration of 12 months
12011684|NCT00505336|Other|No additional treatment|normal disease modifying therapy for heart failure i.e. ACE-I, beta blockers
12011685|NCT00505336|Drug|Atorvastatin|oral Atorvastatin 40mg
12011686|NCT00505323|Device|Implantation of neurostimulators and their auxiliary components|"Implantation neurostimulators and their auxiliary components :
~Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482"
12011687|NCT00505310|Behavioral|Writing|20 minutes of writing on different topics at four different times.
12011688|NCT00505310|Behavioral|Questionnaire|Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
12011689|NCT00505284|Drug|Placebo|Placebo tablets, once daily, for 15 weeks (taken orally).
12011690|NCT00505284|Drug|E2007 (2 mg)|Perampanel, 2 mg once daily, for 15 weeks (taken orally).
12011691|NCT00505284|Drug|E2007 (4 mg)|Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).
12011692|NCT00505284|Drug|E2007 (6 mg)|Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally).
12011693|NCT00505284|Drug|E2007 (8 mg)|Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).
12011694|NCT00505271|Genetic|Rexin-G|"Three patients will receive Rexin-G at Dose Level I. If 1 of 3 patients at Dose Level I develops a grade 3 or 4 adverse event (CTCAE Version 3.0) which appears to be related or possibly related to Rexin-G, then 3 additional patients will be enrolled at the same dose level. If at least 2 of the first 3, or 3 of 6 patients at Dose Level I develop a grade 3 to 4 adverse event which appears to be related or possibly related to Rexin-G, accrual into the study will be held.
~At any dose level, up to six patients may be enrolled if there is evidence of biological activity in the first three patients. Dose escalation may stop if there is impressive evidence of biological activity. An amendment would be submitted to allow further expansion of dose level based on impressive biological activity."
12011695|NCT00505258|Drug|ceftobiprole medocaril|
12011696|NCT00505245|Other|Interview|Complete interview
12011697|NCT00505245|Other|Quality-of-Life Assessment|Complete quality of life assessment
12011698|NCT00505245|Other|Questionnaire Administration|Complete questionnaires
12011738|NCT00504933|Drug|Cetirizine|10 mg (encapsulated) tablets. QD/14 days
12011739|NCT00504933|Drug|Placebo|(encapsulated) Tablets QD/14 days
12011740|NCT00504920|Behavioral|Questionnaire|Questionnaires (30 minutes each) + instruction on telephone survey system for measuring symptoms. Questionnaires 2 times a week while in the hospital or until able to use the telephone survey system.
12011741|NCT00504907|Drug|BTA9881|Single oral escalating doses
12011742|NCT00504907|Drug|Placebo|
12011699|NCT00505232|Drug|Y-90 Ibritumomab tiuxetan|"Study Design
~The present study will be split into two cohorts:
~Patients younger than 60 years who will receive 8 chemotherapy cycles
~Patients older than 60 years who will receive 6 chemotherapy cycles
~The induction schema summarises as follows :
~Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy twice. Afterward, response will be evaluated, followed by, either, four cycles further patients younger than 60 years who will obtain a CR or PR, or 2 cycles patients older than 60 y. (see figure 1 and flow chart).
~Consolidation treatment will consist in a single dose of Y90-Ibritumomab -Tiuxetan (Zevalin) [0.4 mCi/Kg b.w or 0.3 mCi/kg if platelets < 100,000/µl] will be administered 8 to 12 weeks after last chemotherapy."
12011700|NCT00505219|Biological|Ixmyelocel-T|Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.
12011701|NCT00505219|Other|Standard of Care Only|Core decompression of the femoral head to remove necrotic tissue
12011702|NCT00505167|Drug|Memantine|Patients randomized to receive either memantine or donepezil
12011703|NCT00505167|Drug|Donepezil|Patients randomized to receive either memantine or donepezil
12011704|NCT00505154|Drug|Rosuvastatin|Rosuvastatin 10 mg tablets od for 6 months
12011705|NCT00505154|Drug|placebo|placebo
12011706|NCT00505128|Procedure|Endoscopic sphincterotomy|procedure
12011707|NCT00505102|Drug|Everolimus|cyclosporine dose reduced of 50% after introduction of everolimus
12011708|NCT00505089|Drug|ACZ885|
12011709|NCT00505089|Drug|ACZ885|
12011710|NCT00505089|Drug|ACZ885|
12011711|NCT00505089|Drug|ACZ885|
12011712|NCT00505076|Drug|MK-0777|MK-0777 GEM, 8 mg BID
12011713|NCT00505076|Drug|MK-0777|MK-0777 GEM, 3 mg BID
12011714|NCT00505076|Drug|placebo|2 tablets placebo BID
12011715|NCT00505063|Biological|Immunization Schedule patients <7 years.|"Time 0 months: Prevnar 13 #1, Hib #1
~Time 1 months: Pediarix #1
~Time 2 months: Prevnar 13 #2, Hib #2
~Time 3-4 months: Pediarix #2
~Time 4-6 months: Draw post vaccine titers
~Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations."
12011716|NCT00505063|Biological|Immunization Schedule patients > or = to 7 years and <11 years of age|"Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
~Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
~Time 2-3 months: Prevnar 13 #2, Hib #2
~Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations."
12011717|NCT00505063|Biological|Immunization Schedule patients > or = to 11 years of age|"Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
~Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
~Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
~Time 3-6 months: IPV, Draw post vaccine titers
~Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)"
12011718|NCT00505050|Other|Disease Program Management|"This DMP inclused intervention content with education for out patients and caregivers; medication management with optimized therapy based on guidelines, and remote monitoring; delivery personnel with nurses, cardiologists, pharmacists, social workers, dietitians, physical therapists, psychologists; face-to-face individual/group communication, and telephone in-person; the intensity/complexity was long-term follow-up with 6 months interval repetitive education; the environment was hospital out-patient; and the outcomes measured were clinical, quality of life, and adherence.
~After randomization patients undergone our multidisciplinary education sessions 60-minute long that covered the basic principles related to heart failure. Telephone calls were used to reinforce the contents of the sessions of the ambulatory education activity, and monitoring of the compliance/adherence, symptoms/signs of worsening heart failure, and self-control mechanisms."
12011719|NCT00505037|Drug|ASP1585|Oral
12011720|NCT00505037|Drug|Placebo|Oral
12011721|NCT00505037|Drug|Sevelamer hydrochloride|Oral
12011722|NCT00505024|Behavioral|Interactive Voice Response System|Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10.
12011723|NCT00505024|Other|Symptoms Report|A report of severe symptoms will be sent to your doctor or nurse.
12011724|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu 2 times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011725|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011726|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 2 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011727|NCT00504998|Genetic|Rexin-G|Dose Schedule: 3 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has less than Grade 1 or less toxicity.
12011728|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 4 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
12011729|NCT00504985|Behavioral|Surveys|2 surveys, taking about 10-15 minutes each, during Emergency Center visit
12011730|NCT00504972|Drug|hLL1|hLL1 administered intravenously once daily Monday through Friday for 2 consecutive weeks (10 total doses) at one of 4 planned dose levels: 1.5, 4, 6 or 8 mg/kg.
12011731|NCT00504959|Drug|ranibizumab|
12011732|NCT00504946|Drug|prednisone, lactose|"Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
~20mg prednisone+ 0.3mg lactose"
12011733|NCT00504946|Drug|prednisone, colecalciferol, lactose|"Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
~20mg prednisone + 1000j colecalciferol + 0.3mg lactose"
12011734|NCT00504946|Drug|lactose|"Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
~0.3mg lactose"
12011735|NCT00504946|Drug|montelukast sodium|Allergen immunotherapy (build-up phase)premedication with montelukast sodium. Children 6-14 years received 5 mg of montelukast and children > 14 years old received 10mg oral tablet once daily at bedtime
12011736|NCT00504946|Drug|lactose|Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime
12011737|NCT00504933|Drug|bilastine|20 mg (encapsulated) tablets QD/14days
12011743|NCT00504894|Drug|Placebo|A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
12011744|NCT00504894|Drug|Propofol|A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
12011745|NCT00504881|Drug|Placebo|Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period
12011746|NCT00504881|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
12011747|NCT00504855|Other|Casting using Gortex (waterproof) cast padding materials|
12011748|NCT00504855|Other|Casting using cotton/cotton-poly cast padding materials|
12011749|NCT00504842|Drug|MRX-801|
12011750|NCT00504842|Drug|Placebo|
12011751|NCT00504829|Drug|LCP-AtorFen|40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia
12011752|NCT00504829|Drug|atorvastatin|dyslipidemia and mixed dyslipidemia
12011753|NCT00504829|Drug|fenofibrate|dyslipidemia and mixed dyslipidemia
12011754|NCT00504816|Drug|GSK189075|Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
12011755|NCT00504816|Drug|Brevicon|Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
12011756|NCT00504803|Procedure|Mesenchymal stem cell infusion|Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.
12011757|NCT00504790|Drug|GSK923295|anti-mitotic compound
12011758|NCT00504777|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
12011759|NCT00504777|Drug|Methotrexate|10-25mg/week po or parenteral
12011760|NCT00504764|Drug|Arsenic Trioxide|"Induction ATO 0.15 mg/kg/day IV until CR or a maximum of 60 days In isolated molecular relapse ATO will be administered at same dose, 5 days a week, during 6 weeks.
~Consolidation ATO 0.15 mg/kg/day IV 5 days week, during 5 weeks"
12011761|NCT00504764|Procedure|Autologous Transplantation|Autologous Transplantation
12011762|NCT00504764|Procedure|Allogenic Transplantation|Allogenic Transplantation
12011763|NCT00504764|Drug|ATRA|Consolidation: ATRA 45 mg/m²/day oral during 5 weeks
12011764|NCT00504751|Drug|bortezomib, dexamethasone, ifosfamide|"VIPER chemotherapy will be administered every 28 days at the following doses:
~Dexamethasone 40 mg IV days 1-4
~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
~Cisplatin 25 mg IV days 1-4
~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
~VELCADE 1.5 mg/m2 on days 2 and 5"
12011765|NCT00504751|Drug|mesna, cisplatin, etoposide, rituximab|"VIPER chemotherapy will be administered every 28 days at the following doses:
~Dexamethasone 40 mg IV days 1-4
~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
~Cisplatin 25 mg IV days 1-4
~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
~VELCADE 1.5 mg/m2 on days 2 and 5"
12011766|NCT00504725|Drug|Ketamine|Interventional
12011767|NCT00504725|Drug|0.9% saline|placebo
12011768|NCT00504712|Drug|Testosterone|Sustanon- 200mg- Intramuscular testosterone every 2 weeks
12011769|NCT00504712|Drug|saline|Saline injection every two weeks
12011770|NCT00504699|Procedure|Ovarian stimulation in vitro fertilization cryopreservation|Letrozole 5 mg/day during ovarian stimulation
12011771|NCT00504686|Other|manual therapy|manual therapy - thoracic spine thrust manipulation
12011772|NCT00504686|Other|exercise|therapeutic exercise
12011773|NCT00504673|Drug|insulin detemir|
12011774|NCT00504673|Drug|insulin NPH|
12011775|NCT00504673|Drug|insulin aspart|
12011776|NCT00504660|Drug|Capecitabine|Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
12011777|NCT00504660|Drug|Celecoxib (Celebrex)|Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
12011778|NCT00504660|Drug|Temozolomide|Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
12011779|NCT00504660|Drug|Lomustine|Arms 2,3 = 100 mg/m^2 PO on Day 4.
12011780|NCT00504660|Drug|6-Thioguanine|Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
12011781|NCT00504647|Device|Biventricular Pacemaker|
12011782|NCT00504634|Drug|Bortezomib|1 mg/m^2 IV On Days 1, 4, 8, and 11.
12011783|NCT00504608|Drug|Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)|
12011784|NCT00504595|Drug|ACZ885 (investigational)|The ACZ885 was supplied in 6 mL colorless glass vials each containing nominally 150 mg ACZ885 (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
12011785|NCT00504595|Drug|Placebo|Matching placebo of ACZ885 was supplied in the form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
12011786|NCT00504582|Drug|Fibrin Sealant|Tisseel applied externally to the dissected axillary area.
12011787|NCT00504556|Drug|Edoxaban (DU-176b)|30mg tablet once daily
12011788|NCT00504556|Drug|Edoxaban (DU-176b)|60mg tablet once daily
12011789|NCT00504556|Drug|Edoxaban (DU-176b)|30mg tablet two times a day
12011790|NCT00504556|Drug|Edoxaban (DU-176b)|60mg tablet two times a day
12011791|NCT00504556|Drug|warfarin|warfarin tablets
12011792|NCT00504543|Drug|AEB071|oral, twice daily
12011793|NCT00504543|Drug|Certican|twice daily
12011794|NCT00504543|Drug|Neoral|twice daily
12011795|NCT00504530|Drug|Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)|
12011796|NCT00504517|Other|Evaluating Educational Models|Evaluating various forms of educational models for physicians.
12011797|NCT00504504|Drug|Rituximab|375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
12011798|NCT00504504|Drug|Adriamycin|25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
12011799|NCT00504504|Drug|Bleomycin|10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
12012007|NCT00503022|Drug|ACZ885|
12011800|NCT00504504|Drug|Vinblastine|6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
12011801|NCT00504504|Drug|Dacarbazine (DTIC)|375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
12011802|NCT00504491|Drug|Rituximab-CHOP-Alemtuzumab|Four Rituximab - CHOP courses will be given The courses will be given every 21 days
12011803|NCT00504478|Dietary Supplement|omega-3 fatty acids|omega-3 supplement will be given in addition to high complex carbohydrate diet.
12011804|NCT00504478|Other|high complex carbohydrate diet|
12011805|NCT00504465|Drug|dinoprostone|
12011806|NCT00504452|Drug|KP-1461|Oral dosage, 1600 mg bid for 124 days
12011807|NCT00504439|Drug|SB-656933-AAA|The doses of SB-656933 (20 mg, 50 mg or 100 mg) will be provided as a combination of 10 mg and 50 mg tablets of SB-656933-AAA. The tablets will be administered orally.
12011808|NCT00504439|Drug|Matching placebo|SB-656933-AAA matching placebo tablets will be administered orally.
12011809|NCT00504439|Drug|Simvastatin|Simvastatin will be provided as a 40 mg tablet.
12011810|NCT00504426|Drug|OPC-249|1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
12011811|NCT00504413|Drug|midazolam(drug), digoxin (drug)|Midazolam (2mg po) and digoxin (0.5mg po) will be administered one time, an hour apart. Blood concentration will be collected at various points in an 8 hour period.
12011812|NCT00504413|Drug|Bupropion (drug)|Bupropion (150mg po) will be administered one time on a separate visit. Blood concentrations will be collected at various points in a 72 hour period.
12011813|NCT00504413|Drug|Methadone (drug)|Methadone (10mg po) will be administered at a separate visit 2 weeks after the bupropion visit. The dose is given once. Blood concentrations will be measured at various points in a 72 hour period. Pupil constriction will be measured and urine will be collected during this period as well.
12011814|NCT00504400|Drug|Intravitreal injection ranibizumab|Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
12011815|NCT00504374|Behavioral|Questionnaire|Symptoms questionnaire lasting about 5 to 10 minutes.
12011816|NCT00504348|Drug|Tacrolimus|Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
12011817|NCT00504335|Drug|BIO 300 Capsules|
12011818|NCT00504322|Genetic|AdcuCD40L|Using Weill-IRB protocol #0011004683 dose escalation study to determine the highest non-toxic dose of the AdcuCD40L vector, this dose (likely 10^11 particle units) will be used for all individuals enrolled in this efficacy study. Since there is no evidence that delay of surgery for solid tumors for 15 days following diagnosis alters the prognosis, surgery for removal of the primary tumor will be carried out at either 5 or 15 days after administration of the vector (n= 12/group, including n=6 receiving the AdcuCD40L vector, and n=6 receiving placebo). This will permit assessment of the resulting data (in a randomized, blinded fashion) and the biologic responses to the AdCUCD40L vector over time.
12011819|NCT00504322|Genetic|Placebo|The placebo will be the salt water-sugar solution used as a vehicle for the vector.
12011820|NCT00504309|Drug|4/day of 4g P-OM3 capsules|4/day of 4g P-OM3 capsules for 8 weeks
12011821|NCT00504309|Drug|4/day of 1g P-OM3 capsules|4/day of 1g P-OM3 capsules for 8 weeks
12011822|NCT00504309|Drug|Corn Oil Placebo, 4 capsules/day for 8 weeks|4 capsules per day of corn oil placebo for 8 weeks
12011823|NCT00504296|Drug|HDAC inhibitor SB939|SB939 will be administered initially for 3 consecutive days every other week at the first dose level and then for 5 consecutive days every other week at escalating doses.
12011824|NCT00504296|Other|immunoenzyme technique|
12011825|NCT00504296|Other|immunohistochemistry staining method|
12011826|NCT00504296|Other|immunologic technique|
12011827|NCT00504296|Other|laboratory biomarker analysis|
12011828|NCT00504296|Other|liquid chromatography|
12011829|NCT00504296|Other|mass spectrometry|
12011830|NCT00504296|Other|pharmacological study|
12011831|NCT00504283|Drug|Toradol|
12011832|NCT00504283|Drug|Morphine|
12011833|NCT00504270|Drug|Placebo|po daily
12011834|NCT00504270|Drug|RG3421 120mg|120mg po daily
12011835|NCT00504270|Drug|RG3421 20mg|20mg po daily
12011836|NCT00504257|Drug|Avastin|Day 1, every 21 day cycle
12011837|NCT00504257|Drug|Docetaxel|Day 1, 8, every 21 day cycle
12011838|NCT00504244|Drug|switch to Myfortic|Myfortic 2 dd 720 mg
12011839|NCT00504244|Drug|continuation of azathioprine|Azathioprine 2 mg/kg
12011840|NCT00504231|Biological|Fluzone Influenza Vaccine (2007-2008)|Manufactured by Sanofi Pasteur
12011841|NCT00504205|Drug|multitargeted receptor tyrosine kinase inhibitor MP470|
12011842|NCT00504205|Other|laboratory biomarker analysis|
12011843|NCT00504205|Other|pharmacological study|
12011844|NCT00504205|Procedure|positron emission tomography|
12011845|NCT00504192|Drug|Gemcitabine and Oxaliplatin|gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks
12011846|NCT00504179|Procedure|Osteopathic Manipulative Treatment|
12011847|NCT00504166|Drug|alendronate sodium|alendronate sodium 70 mg tablet once week for 24 months
12011848|NCT00504166|Other|placebo comparator|placebo to match alendronate sodium one tablet once a week for 24 months
12011849|NCT00504153|Drug|dasatinib|
12011850|NCT00504153|Other|laboratory biomarker analysis|Correlative studies
12011851|NCT00504140|Drug|Etoposide|100 mg/m^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.
12011852|NCT00504140|Drug|Interferon Alpha|5x10^6 mu/m^2 Subcutaneously Daily for 5 Days
12011853|NCT00504127|Drug|Naproxcinod 375 mg bid|Naproxcinod 375 mg bid
12011854|NCT00504127|Drug|Naproxcinod 750 mg bid|Naproxcinod 750 mg bid
12011855|NCT00504127|Drug|Naproxen 500 mg bid|Naproxen 500 mg bid
12011856|NCT00504127|Drug|placebo|placebo
12011857|NCT00504114|Procedure|ACL Reconstruction Surgery|
12011858|NCT00504114|Procedure|Cartilage Resurfacing Surgery|
12011859|NCT00504114|Procedure|Total Knee Replacement|
12011860|NCT00504101|Drug|Arsenic trioxide|Arsenic Trioxide will be given on day -6, -5, -4,-3,-2 (total of 5 doses). The dose of Arsenic trioxide (ATO) is 0.25 mg/m2.
12012008|NCT00503009|Drug|fluticasone propionate/salmeterol|comparator
12011861|NCT00504101|Drug|Bortezomib|Bortezomib will be given on day -6, -4, -2 (total 3 doses) beginning at a dose of 0.8 mg/m2 each day of therapy.
12011862|NCT00504101|Drug|Melphalan|Melphalan will be given at 200 mg/m2 on day -2 (1 dose only)
12011863|NCT00504101|Biological|Autologous hematopoietic stem cell transplantation|On day 0 a minimal of 2 x 106 CD 34 cells/kg will be infused by central catheter according to institutional standards.
12011864|NCT00504088|Procedure|Bypass|
12011865|NCT00504088|Procedure|Silverhawk Plaque Excision|
12011866|NCT00504075|Biological|Gammaplex, intravenous immunoglobulin|"Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG).
~The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX."
12011867|NCT00504062|Drug|budesonide|
12011868|NCT00504062|Drug|fluticasone|
12011869|NCT00504036|Device|inflatable intra-gastric balloon|inflatable intra-gastric balloon
12011870|NCT00504023|Drug|imiquimod|The patient will be seen in clinic every six weeks during treatment for examination. Imiquimod cream is to be applied 3 times per week for 12 weeks.
12011871|NCT00504023|Procedure|biopsy|Punch biopsy and photography will be performed at the baseline and 12 week time points.
12011872|NCT00504023|Procedure|therapeutic conventional surgery|If the lesion is still present after 12 weeks of therapy, the treating physician will recommend excision of the lesion four weeks after completion of therapy (week 16).
12011873|NCT00504010|Drug|Arnica Montana|Applied to lower extremity once a day for 3 days
12011874|NCT00504010|Drug|placebo cream|placebo cream applied to leg daily for 3 days
12011875|NCT00503997|Drug|oxaliplatin|"Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
~Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy."
12011876|NCT00503997|Drug|pemetrexed disodium|"Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
~Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy."
12011877|NCT00503984|Drug|Azacitidine|Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.
12011878|NCT00503984|Drug|Docetaxel|Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.
12011879|NCT00503984|Drug|Prednisone|Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.
12011880|NCT00503984|Genetic|GADD45α methylation and expression analysis|"Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing.
~Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so."
12011881|NCT00503984|Drug|Pegfilgrastim|Growth factor support.Granulocyte-colony stimulating factor (G-CSF)
12011882|NCT00503984|Drug|Filgrastim|Growth factor support. Granulocyte-colony stimulating factor (G-CSF)
12011883|NCT00503971|Drug|Vorinostat plus Erlotinib|"Phase I:
~Dose level 1: 300 mg V d1-7 every 21 days plus 100 mg E daily Dose level 2: 400 mg V d1-7 every 21 days plus 100 mg E daily Dose level 2b: 300 mg V d1-7 and 15-21 every 28 days plus 100 mg E daily Dose level 3: 400 mg V d1-7 and 15-21 every 28 days plus 150 mg E daily
~Phase II:
~Dose level 3: 400 mg V d1-7 and 15-21 every 28 days plus 150 mg E daily"
12011884|NCT00503958|Genetic|DNA methylation analysis|
12011885|NCT00503958|Genetic|DNA stability analysis|
12011886|NCT00503958|Genetic|gene expression analysis|
12011887|NCT00503958|Other|epidemiologic study|
12011888|NCT00503958|Other|study of socioeconomic and demographic variables|
12011889|NCT00503958|Procedure|biopsy|
12011890|NCT00503958|Procedure|evaluation of cancer risk factors|
12011891|NCT00503958|Procedure|study of high risk factors|
12011892|NCT00503945|Device|Nasal continuous positive airway pressure (nCPAP)|
12011893|NCT00503932|Procedure|Proton Therapy|Radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all).
12011894|NCT00503932|Drug|Capecitabine|825 mg/m^2 by mouth (PO) twice daily on days receive radiation.
12011895|NCT00503919|Procedure|Multi-spectral Digital Colposcopy (MDC)|Use of a digital camera and a special light to take pictures of the cervix and vagina.
12011896|NCT00503906|Drug|Avastin|
12011897|NCT00503906|Drug|Gemcitabine|
12011898|NCT00503906|Drug|Abraxane|
12011899|NCT00503893|Behavioral|Questionnaire|Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.
12011900|NCT00503893|Other|Blood specimen|Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.
12011901|NCT00503880|Biological|filgrastim|subcutaneously one day prior to treatment
12011902|NCT00503880|Drug|clofarabine|single IV dose over 1 hour daily for 5 days
12011903|NCT00503880|Drug|cytarabine|subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion
12011904|NCT00503880|Genetic|microarray analysis|Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.
12011905|NCT00503880|Procedure|biopsy|bone marrow biopsy
12011906|NCT00503867|Device|SIR-Spheres microspheres|SIR-Spheres Yttrium-90 microspheres
12011907|NCT00503854|Behavioral|Questionnaire|Ancillary studies
12011908|NCT00503841|Drug|erlotinib hydrochloride|Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
12012009|NCT00503009|Drug|fluticasone propionate|Comparator
12012010|NCT00503009|Drug|placebo|Placebo
12011909|NCT00503841|Other|immunohistochemistry staining method|Assessed at the time of the initial biopsy and at the time of surgery.
12011910|NCT00503841|Other|laboratory biomarker analysis|Correlative studies
12011911|NCT00503841|Procedure|biopsy|14 days prior to surgery
12011912|NCT00503841|Procedure|conventional surgery|14 days after taking study drug erlotinib hydrochloride.
12011913|NCT00503841|Procedure|neoadjuvant therapy|14 days after taking study drug erlotinib hydrochloride.
12011914|NCT00503828|Drug|Derris scandens Benth extracts|Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks
12011915|NCT00503828|Drug|naproxen|Naproxen 500 mg/day for 4 weeks
12011916|NCT00503815|Drug|BLI-800|
12011917|NCT00503815|Drug|Polyethylene glycol 3350 based bowel preparation|
12011918|NCT00503802|Procedure|Radiofrequency Turbinate Reduction|Radiofrequency Turbinate Reduction
12011919|NCT00503802|Procedure|Sham RF|The steps of the procedure are as follows: 1) application of topical anesthetic to the turbinate mucosa bilaterally; 2) injection of 1.0 ml of lidocaine 1% with epinephrine 1:100,000 with a 30-gauge needle into each inferior turbinate anteriorly; 3) delay five minutes for local anesthetic to take full effect; 4) re-insertion of the anesthetic needle to check for complete anesthesia on one side, and injection of another 1.0 ml of lidocaine 1% with epinephrine 1:100,000 5) placement of the radiofrequency electrode (23-gauge, 1 cm long) into the inferior turbinate; 6) delivery of 300 Joules of radiofrequency energy to the turbinate over 29 seconds (no energy will be delivered in sham procedure)7) placement of a cotton pledget (soaked in oxymetazoline solution 0.05%) against the treatment site 8) repeat steps 3 - 8 for the contra-lateral inferior turbinate; 9) removal of the cotton pledgets after several minutes; and 11) observation of hemostasis.
12011920|NCT00503789|Procedure|fecal bacteria analysis|ad lib feeding
12011921|NCT00503776|Behavioral|exercise intervention|Patients undergo low weight resistance training.
12011922|NCT00503776|Drug|amifostine trihydrate|Given subcutaneously
12011923|NCT00503776|Procedure|therapeutic dietary intervention|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
12011924|NCT00503763|Drug|Simvastatin|
12011925|NCT00503750|Drug|Pre operativeTrastuzumab|"Trastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion.
~As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52."
12011926|NCT00503750|Drug|ABI-007 (Abraxane)|ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8).
12011927|NCT00503750|Drug|Vinorelbine|Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20).
12011928|NCT00503737|Behavioral|National Colorectal Cancer Roundtable Toolbox|
12011929|NCT00503724|Drug|enzastaurin hydrochloride|Participants receive 200, 260, 340, or 440 mg/m2/day of enzastaurin orally once daily for 28 days (one course) during the dose escalation phase of the study. To study the toxicity profile of the MTD or phase II recommended dose established during the dose escalation phase, participants receive twice daily doses of enzastaurin orally at the phase II recommended dose for 28 days (one course). In the absence of unacceptable toxicity or disease progression, treatment may continue for 13 courses (approximately one year).
12011930|NCT00503711|Drug|Vandetanib|100 mg every other day, 100mg once daily
12011931|NCT00503711|Drug|Vandetanib 300 mg|300mg once daily
12011932|NCT00503698|Drug|somatropin|20 mcg/kg/day, injected s.c. (under the skin)
12011933|NCT00503698|Drug|placebo|Placebo injected s.c (under the skin)
12011934|NCT00503685|Biological|IMC-A12|10 milligrams/kilogram (mg/kg) intravenous infusion every 2 weeks.
12011935|NCT00503685|Biological|cetuximab|Participants will receive cetuximab 500 milligrams/square meter (mg/m²) intravenous over 2 hours every 2 weeks.
12011936|NCT00503659|Procedure|Bronchial methacholine provocation|A short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine)
12011937|NCT00503659|Procedure|Bronchial methacholine provocation|A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)
12011938|NCT00503646|Other|communication intervention|
12011939|NCT00503646|Other|counseling intervention|
12011940|NCT00503646|Other|questionnaire administration|
12011941|NCT00503646|Procedure|psychosocial assessment and care|
12011942|NCT00503620|Drug|Botulinum Toxin A|Injection into the gastrocnemius/soleus muscles for spasticity
12011943|NCT00503607|Drug|BLI-800|
12011944|NCT00503607|Drug|Polyethylene glycol 3350 based bowel preparation|
12011945|NCT00503594|Drug|Methotrexate and temozolomide|Methotrexate and temozolomide
12011946|NCT00503594|Drug|Methotrexate , procarbazine ,vincristine ,cytarabine|Methotrexate , procarbazine ,vincristine ,cytarabine
12011947|NCT00503581|Procedure|Biopsy|Undergo biopsy
12011948|NCT00503581|Other|Laboratory Biomarker Analysis|Correlative studies
12011949|NCT00503581|Drug|Megestrol Acetate|given orally
12011950|NCT00503581|Other|Pharmacological Study|Correlative studies
12011951|NCT00503581|Other|Quality-of-Life Assessment|Ancillary studies
12011952|NCT00503581|Procedure|Therapeutic Conventional Surgery|undergo hysterectomy
12011953|NCT00503568|Biological|Ad100-gp96Ig-HLA A1|Dose Schedule 1 (DS-1): 4x10^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10^7 cells twice weekly, maximum 36 vaccines/patient
12011954|NCT00503542|Drug|Terazol or oral fluconazole for candidal vaginitis|Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1
12011955|NCT00503542|Drug|Metronidazole or Clindamycin for Bacterial Vaginosis|Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin
12011956|NCT00503542|Drug|Flagyl for definitively diagnosed vaginal trichomoniasis|Metronidazole 2 gms po x 1
12011957|NCT00503542|Other|Empiric Management|In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.
12011958|NCT00503529|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus)
12011959|NCT00503516|Drug|Megestrol acetate|1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks
12011960|NCT00503516|Drug|Placebo|1 sachet of 160 mg of placebo b.i.d.
12011961|NCT00503503|Drug|Enbrel (etanercept)|
12011962|NCT00503490|Drug|MP-376 (Levofloxacin solution for Inhalation)|40, 80, 120mg RDD
12011963|NCT00503490|Drug|placebo|BID
12011964|NCT00503477|Drug|AZD2171|oral tablet
12011965|NCT00503451|Drug|LBH589|
12011966|NCT00503438|Device|Salto Talaris Ankle|Salto Talaris Anatomic Ankle total joint prosthesis
12011967|NCT00503425|Drug|Rituximab [MabThera/Rituxan]|1000 mg IV on days 1 and 15
12011968|NCT00503412|Drug|AZD2171|oral 14C
12011969|NCT00503399|Drug|Teriparatide|20 µg/day sc for 18 months
12011970|NCT00503399|Drug|Risedronate|35 mg/week po for 18 months
12011971|NCT00503386|Drug|Palonosetron|
12011972|NCT00503386|Drug|Granisetron|
12011973|NCT00503360|Drug|SAD448|
12011974|NCT00503347|Drug|bavituximab|The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab.
12011975|NCT00503334|Dietary Supplement|preOP booster (oral nutritional supplement, food for special medical purposes)|3x1 dosage pre-operatively
12011976|NCT00503321|Drug|Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)|S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day
12011977|NCT00503321|Drug|Tegafur/gimeracil/oteracil potassium (S-1)|S-1 80mg/m2, 4weeks on followed by 2 weks off
12011978|NCT00503308|Procedure|Abbreviated HIV test counseling|abbreviated HIV pre-test counseling
12011979|NCT00503295|Biological|REOLYSIN®|REOLYSIN® is given intravenously at a dose of 3x10E10 TCID50 over 60 minutes on Days 1-5 of a 28 day cycle.
12011980|NCT00503269|Procedure|Hemorrhoidectomy|Hemorrhoidectomy under local anaesthesia
12011981|NCT00503269|Procedure|Hemorrhoidectomy|General anaesthetic haemorrhoidectomy
12011982|NCT00503256|Behavioral|Questionnaire|Questionnaires each taking 60 minutes to complete.
12011983|NCT00503243|Drug|Delayed and extended release mesalazine|
12011984|NCT00503230|Behavioral|Standard Care Intervention (SCI)|Standard Care Intervention (SCI)
12011985|NCT00503230|Behavioral|Culturally Tailored Intervention (CTI)|Culturally Tailored Intervention (CTI)
12011986|NCT00503217|Drug|Tryptorelin|
12011987|NCT00503204|Drug|Cediranib|oral tablet
12011988|NCT00503204|Drug|Lomustine|oral capsule
12011989|NCT00503191|Behavioral|NeuroModulation Technique|NeuroModulation Technique is an informational technique that works by identifying and bringing awareness of the mind-body to incorrect informational states of the nervous system which has led to illness or maladaptive behavior. NeuroModulation Technique then directs the body to correct these information states, thereby helping the nervous system resume more adaptive functioning.
12011990|NCT00503178|Procedure|Biological imaging guided antalgic radiotherapy|Biological imaging guided antalgic radiotherapy is followed.
12011991|NCT00503165|Biological|Menitorix (MenC and Hib conjugate)|
12011992|NCT00503152|Drug|Benazepril|After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
12011993|NCT00503152|Drug|Valsartan|After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
12011994|NCT00503152|Drug|Benazepril/Valsartan|After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
12011995|NCT00503139|Drug|Enbrel (etanercept)|Enbrel 10 to 25 mg twice a week subcutaneous injection
12011996|NCT00503126|Drug|bivalirudin|anticoagulation
12011997|NCT00503113|Drug|ibandronate [Bonviva/Boniva]|3mg intravenous (iv) injection every 3 months
12011998|NCT00503113|Drug|ibandronate [Bonviva/Boniva]|3mg intravenous (iv) infusion every 3 months
12011999|NCT00503113|Drug|Alendronate|70mg per oral (po) weekly
12012000|NCT00503100|Device|Thermal stimulation|Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.
12012001|NCT00503087|Procedure|Saline Injection|
12012002|NCT00503087|Device|Pneumatic Skin Flattening (PSF)|
12012003|NCT00503074|Behavioral|TV modification|Parents receive a health behavior-change intervention consisting of 1 in-person visit from a case manager, followed by phone and e-mail contact at least monthly. The intervention is designed to promote healthy TV viewing, including viewing fewer commercials, by the target child aged 2-5 years old, and uses health behavior change theory and social cognitive theory.
12012004|NCT00503074|Behavioral|safety and injury prevention|Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.
12012005|NCT00503035|Drug|Celecoxib|400 mg by mouth twice daily x 6 months
12012006|NCT00503035|Procedure|Colonoscopy Biopsy|Up to 23 additional colon tissue biopsies (the size of a pencil tip), additional 20 minutes on colonoscopy procedure
12012012|NCT00502996|Drug|rituximab [MabThera/Rituxan]|1g iv on days 1 and 15
12012013|NCT00502983|Behavioral|Interview|Interview lasting approximately 50 minutes.
12012014|NCT00502970|Drug|16 weeks Interferon Tiw with Ribavirin|16 weeks Interferon Tiw
12012015|NCT00502970|Drug|24 weeks Interferon|24 weeks Interferon Tiw with Ribavirin
12012016|NCT00502957|Behavioral|Biofeedback|
12012017|NCT00502944|Behavioral|Counselor-based HIV screening|Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
12012018|NCT00502944|Behavioral|Emergency staff member-based HIV screening|Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months
12012019|NCT00502918|Device|CLM - HA Continuous Monitoring System Heart Application|
12012020|NCT00502905|Drug|Busulfan|130 mg/m^2 injected through the intravenous catheter over three hours, once a day, for four days, starting immediately after Fludarabine.
12012021|NCT00502905|Drug|Fludarabine|40 mg/m^2 through a central venous catheter over one hour, once a day, for four days.
12012022|NCT00502892|Drug|Topotecan|0.5 mg/m^2 IV Daily x 3 Days
12012023|NCT00502892|Drug|Ifosfamide|1.8 grams/m^2 IV Over 1 Hour x 5 Days
12012024|NCT00502892|Drug|Carboplatin|AUC = 3 mg/ml/min IV Over 1 Hour x 3 Days [for patients > 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days]
12012025|NCT00502879|Drug|Enbrel (etanercept)|
12012026|NCT00502853|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
12012027|NCT00502853|Drug|Methotrexate|10-25mg/week
12012028|NCT00502840|Drug|rituximab [MabThera/Rituxan]|1g iv on days 1 and 15
12012029|NCT00502827|Behavioral|Cell Phone Intervention|Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.
12012030|NCT00502827|Other|Recommended Standard of Care|Advice from your physician to stop smoking and written materials designed to help you quit smoking.
12012031|NCT00502814|Procedure|3-D Optical Surface Scan|3-D digitized images of the breasts and chest will be taken over a period of five minutes.
12012032|NCT00502814|Procedure|Mechanical Testing|A small device with a mild suction will be used to measure how the skin tends to stretch.
12012033|NCT00502814|Procedure|Cutaneous Ultrasound|Cutaneous ultrasound using a 20 MHz machine and the skin thickness will be recorded.
12012034|NCT00502814|Procedure|Breast MRI and/or CT|Imaging of the breasts and chest using an MRI and/or CT scan over about one hour.
12012035|NCT00502801|Drug|doripenem|1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
12012036|NCT00502788|Drug|Peginterferon Alfa-2a and Ribavirin|"Patients will be treated with alfa-2a and ribavirin as follows:
~Peginterferon alfa-2a will be started as a dose of 180 ug subcutaneously once weekly."
12012037|NCT00502788|Drug|Ribavirin|Ribavirin will be started at a dose of 800mg daily for those weighing less than or equal to 50 kg, 1000 mg daily for those with body weight 51 to 75 kg and 1200 mg daily for those with body weight > 75 kg. Ribavirin will be given orally in two divided doses. The lower dose has been included because potentially-eligible patients in the TCRN registry have a mean weight of 57 kg.
12012038|NCT00502775|Drug|fluticasone furoate, fexofenadine|
12012039|NCT00502762|Drug|topotecan|
12012040|NCT00502749|Behavioral|Exercise program|Daily group or personal exercise programs designed to promote flexibility, endurance, and strength.
12012041|NCT00502749|Behavioral|Questionnaires|Questionnaires taking 15 minutes to complete.
12012042|NCT00502736|Drug|ibandronate [Bondronat]|6mg iv on days 1-3
12012043|NCT00502723|Procedure|Radical retropubic prostatectomy|Radical retropubic prostatectomy
12012044|NCT00502723|Procedure|Radical laparoscopy prostatectomy|Radical laparoscopy prostatectomy
12012045|NCT00502710|Drug|Placebo|Placebo po daily.
12012046|NCT00502710|Drug|RO4876904|Escalating doses, at a starting dose of 12.5mg po daily.
12012047|NCT00502697|Behavioral|Targeted Nurse Home Visits|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic care. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
12012048|NCT00502697|Other|Conventional prenatal/postpartum care|Women in this group received conventional prenatal care and postpartum clinic care.
12012049|NCT00502684|Drug|Propranolol, etodolac|propranolol 10 mg X 4 /day, starting on day -3 pre-op, for 6 days, till POD 2 Etodolac 400 mg X2/day, starting on day -3 pre-op, for 6 days, till POD 2
12012050|NCT00502671|Drug|capecitabine [Xeloda]|1250mg/m2 po bid on days 1-14 of each 3 week cycle
12012051|NCT00502658|Behavioral|Dietary supplement containing vitamins, minerals, and herbs|
12012052|NCT00502658|Behavioral|Shakes with nutrients and herbs|
12012053|NCT00502658|Behavioral|Control dietary supplement|
12012054|NCT00502658|Behavioral|Isocaloric, isonitrogenous control shakes without herbs|
12012055|NCT00502658|Behavioral|Personal energy tracking tool|
12012056|NCT00502645|Device|CS-1 DECISION SUPPORT SYSTEM|
12012057|NCT00502632|Drug|Urokinase and Dornase alfa|"Intrapleural administration of:
~Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
~Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days"
12012058|NCT00502632|Drug|Urokinase|"Intrapleural administration of:
~Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
~25ml normal saline, twice daily for 4 days"
12012059|NCT00502619|Procedure|Acupuncture|A specific regimen of acupuncture sites will be needled twice weekly for eight weeks and once weekly for a subsequent eight weeks.
12012060|NCT00502619|Other|Treadmill Exercise|After the first four weeks of acupuncture treatments, subjects will initiate a three times per week treadmill program, which will continue for a total of 12 weeks in conjunction with the acupuncture treatments.
12012061|NCT00502593|Biological|Pandemic Influenza Vaccine (GSK1562902A)|2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.
12012062|NCT00502593|Biological|Fluarix™|2 doses, intramuscular injection on Days 0 and 21.
12012063|NCT00502580|Behavioral|Interview|Interview taking about 10 minutes to complete.
12012064|NCT00502567|Drug|AZD2171|oral tablet once daily
12012065|NCT00502567|Drug|FOLFOX|intravenous infusion
12012066|NCT00502567|Drug|Pemetrexed|intravenous infusion
12012067|NCT00502567|Drug|Irinotecan (administered with & without Cetuximab)|intravenous injection
12012068|NCT00502567|Drug|Docetaxel|intravenous infusion
12012069|NCT00502554|Procedure|photopheresis|2-day cycles of photopheresis every 3 weeks for 3 months
12012070|NCT00502541|Drug|fluocinolone acetonide|fluocinolone acetonide 0.59 mg intravitreal implant
12012071|NCT00502541|Procedure|Standard of Care|Repeat macular grid laser or observation
12012072|NCT00502528|Drug|Placebo|Peri-interventional
12012073|NCT00502528|Drug|BQ-123|Peri-interventional
12012074|NCT00502515|Drug|SSR180575|Oral, once daily dosing
12012075|NCT00502515|Drug|Placebo|Oral, once daily dosing
12012076|NCT00502502|Behavioral|Questionnaire|Weekly questionnaires lasting about 30 minutes.
12012077|NCT00502489|Procedure|Closed-loop sytem for5 weaning from mechanical ventilation|
12012078|NCT00502476|Procedure|Bathing with Chlorhexidine Impregnated Washcloths|
12012079|NCT00502463|Procedure|radio-immunotherapy|
12012080|NCT00502437|Drug|GRANISETRON|
12012081|NCT00502424|Device|Splint|
12012082|NCT00502411|Drug|Doxorubicin|17.5 mg/m^2 IV bolus infusion, followed by continuous IV infusion on days 1-4.
12012083|NCT00502411|Radiation|Radiation Therapy|Radiation treatments 5 days a week for 6 - 6 1/2 weeks. 60 Gy in 6 weeks (negative resection margin) to 66 Gy in 6.5 weeks (positive resection margin).
12012084|NCT00502398|Procedure|Blood test|
12012085|NCT00502385|Drug|AZD2171|
12012086|NCT00502372|Dietary Supplement|Nutritional Supplement/Amino acids and HMB|Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement
12012087|NCT00502372|Dietary Supplement|Juven|comparison of Juven with arginine only product in wound healing
12012088|NCT00502359|Device|capillary blood glucose measurement|
12012089|NCT00502346|Drug|PM10|
12012090|NCT00502320|Drug|Ramelteon|one 8 mg tablet at bed for up to 4 months
12012091|NCT00502320|Drug|Placebo|one tablet at bedtime for up to 4 months
12012092|NCT00502307|Drug|Tivozanib (AV-951)|solid oral dosage form taken daily for three weeks per one month cycle
12012093|NCT00502307|Drug|Placebo comparator|solid oral capsule containing excipients dosed daily for three weeks per month
12012094|NCT00502294|Drug|Visilizumab (HuM291; Nuvion®)|
12012095|NCT00502281|Drug|highly purified urinary FSH|
12012096|NCT00502281|Behavioral|timed intercourses, intrauterine insemination|
12012097|NCT00502268|Drug|Doxercalciferol administration|Doxercalciferol administration
12012098|NCT00502268|Drug|Doxercalciferol administered by 1-84-7-84|Doxercalciferol administered by 1-84-7-84
12012099|NCT00502255|Device|Health Buddy system|Patients are followed on distance by the Health Buddy system.
12012100|NCT00502255|Device|Telemonitoring in patients with heart failure|Health Buddy in patients home situation.
12012101|NCT00502242|Drug|ramipril|Capsule - initial treatment is 5 mg (active)- oral - once per day
12012102|NCT00502242|Drug|ramipril|Capsule - initial treatment is 5 mg (placebo) - oral - once per day
12012103|NCT00502229|Drug|Clomiphene citrate, metformin, highly purified urinary FSH|
12012104|NCT00502216|Drug|Naltrexone|Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
12012105|NCT00502216|Drug|Varenicline|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day; Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
12012106|NCT00502203|Drug|Carboplatin|AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses
12012107|NCT00502203|Drug|Paclitaxel|175 mg/m^2 By Vein Over 3 Hours Every 21 Days for 6 Courses
12012108|NCT00502190|Device|Silicon ring positioned in the vagina, around the cervix|Silicon ring positioned in the vagina, around the cervix
12012109|NCT00502177|Behavioral|Questionnaire|QOL Questionnaires taking a total of 10 minutes to complete.
12012110|NCT00502164|Drug|AZD2171|
12012111|NCT00502138|Drug|Continuous Pramlintide infusion|pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
12012112|NCT00502125|Procedure|Reflectance Confocal Imaging|A photograph will be taken of any abnormal areas inside the mouth. A small probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.
12012113|NCT00502112|Drug|lintuzumab|4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
12012114|NCT00502112|Drug|lenalidomide|10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
12012115|NCT00502099|Drug|Pegylated interferon alpha 2a|Injections: 180 ug once per week
12012116|NCT00502099|Drug|Ribavirin|Tablets, 1000-1200 daily
12012117|NCT00502099|Drug|Pegylated interferon alpha 2 b plus ribavirin|Pegylated interferon alpha 2 b injections
12012118|NCT00502086|Dietary Supplement|Viusid (nutritional supplement)|Viusid three sachets daily during 96 weeks
12012119|NCT00502086|Other|Placebo|Placebo three sachets daily during 96 weeks
12012120|NCT00502073|Drug|cyclosporine|
12012121|NCT00502060|Drug|AZD2171|
12012122|NCT00502060|Drug|ZD1839|
12012123|NCT00502047|Drug|Plantago ovata husk|
12012124|NCT00502034|Drug|Interferon Alfa-2a|Interferon Alfa-2a in combination with Interleukin
12012125|NCT00502034|Drug|Interleukin-2|Interferon Alfa-2a in combination with Interleukin
12012126|NCT00502021|Dietary Supplement|Placebo|Manioc powder (placebo) 60 g/day
12012127|NCT00502021|Dietary Supplement|Alpha-linolenic acid/ALA|Flaxseed powder 60 g/day (10 g ALA)
12012128|NCT00502021|Dietary Supplement|Alpha linolenic acid/ALA|Flaxseed oil 30 ml/day (10 g ALA)
12012129|NCT00502021|Dietary Supplement|Placebo|Safflower oil 30 ml/day
12012130|NCT00502008|Drug|Coccinia Cordifolia (herbal extract)|
12012131|NCT00501995|Drug|IV Cyclophosphamide|Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)
12012132|NCT00501982|Drug|Poractant alfa (Curosurf®)|
12012133|NCT00501969|Drug|Rotigotine|"Rotigotine trans-dermal patches once daily:
~20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)"
12012134|NCT00501956|Drug|Intradialytic Parenteral Nutrition (IDPN)|compounded IDPN, 3 x/week, 16 weeks intervention
12012135|NCT00501943|Drug|Avonex (Interferon beta 1a)|
12012136|NCT00501943|Drug|Riluzole|
12012137|NCT00501943|Drug|Placebo|
12012138|NCT00501930|Drug|GSK189075|
12012139|NCT00501917|Drug|G-CSF with/without darbepoetin, peripheral blood stem cell infusion|
12012140|NCT00501904|Drug|Metformin|
12012141|NCT00501891|Drug|Bevacizumab|Bevacizumab administered intravenously 10mg/kg every other week.
12012142|NCT00501891|Drug|Metronomic Temozolomide|Temozolomide 50mg/m2 given orally on a daily basis.
12012143|NCT00501878|Drug|2.5% or 10% phenylephrine|
12012144|NCT00501865|Drug|GW273225|GW273225 will be available as white tablets containing 25 mg GW273225.The study drug will be taken with 240 milliliters of water at room temperature.
12012145|NCT00501852|Drug|NVA237|single-dose dry-powder inhaler (SDDPI)
12012146|NCT00501852|Drug|Placebo|single-dose dry-powder inhaler (SDDPI)
12012147|NCT00501852|Drug|Tiotropium|Handihaler inhaler
12012148|NCT00501839|Drug|clomiphene citrate|
12012149|NCT00501826|Drug|Cyclophosphamide|Given IV
12012150|NCT00501826|Drug|Cytarabine|Given IV
12012151|NCT00501826|Drug|Dexamethasone|Given IV or PO
12012152|NCT00501826|Drug|Doxorubicin Hydrochloride|Given IV
12012153|NCT00501826|Drug|Mercaptopurine|Given PO
12012154|NCT00501826|Drug|Methotrexate|Given IV and PO
12012155|NCT00501826|Drug|Nelarabine|Given IV
12012156|NCT00501826|Drug|Pegaspargase|Given IV
12012157|NCT00501826|Drug|Prednisone|Given PO
12012158|NCT00501826|Drug|Venetoclax|Given PO
12012159|NCT00501826|Drug|Vincristine Sulfate|Given IV
12012160|NCT00501813|Procedure|Hepatectomy|irregular Hepatectomy
12012161|NCT00501813|Procedure|TACE combined with local regional therapies without hepatectomy|TACE combined with RFA, MCT, PEI, and so on.
12012162|NCT00501787|Drug|Metformin|
12012163|NCT00501761|Behavioral|Personalized Exercise Program|Walking up to thirty minutes on most days of the week.
12012164|NCT00501761|Behavioral|Questionnaire|Questionnaires regarding physical activity, exercise, and quality of life.
12012165|NCT00501761|Behavioral|Suggested Exercise Program|Exercise program performed over 7 days.
12012166|NCT00501748|Drug|Rituximab|Rituximab is a highly purified, 1328-amino acid antibody with an approximate molecular mass of 145 kD. Rituximab is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration. Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials. In this single arm study all subjects are treated with two cycles of rituximab. Each cycle consists of two 1000 mg infusions administered two weeks apart. The cycles of rituximab treatment are administered at baseline and at 9 months.
12012167|NCT00501735|Drug|Forodesine 200 mg|2 x 100mg tablets once daily
12012168|NCT00501722|Drug|satavaptan (SR121463B)|
12012169|NCT00501709|Drug|Belatacept and Raptiva|immunosuppressant agent to prevent rejection in transplant recipients
12012170|NCT00501696|Drug|4.5 mg Naltrexone|low dose naltrexone 4,5mg on the multiple sclerosis quality of life inventory (MSQLI54)
12012171|NCT00501696|Drug|Naltrexone|4,5mg low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)
12012172|NCT00501683|Drug|Radiolabelled GSK189075|
12012173|NCT00501670|Procedure|Herpes zoster sampling procedure for VZV PCR|Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.
12012174|NCT00501670|Procedure|Blood sampling|Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.
12012175|NCT00501657|Drug|Sitagliptin|100mg mane for 2 days
12012176|NCT00501657|Drug|Placebo|100mg mane for 2 days
12012177|NCT00501644|Drug|Carboplatin|AUC of 5 by 1 hour IV infusion every 28 days.
12012178|NCT00501644|Drug|GM-CSF (Sargramostim)|Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy.
12012179|NCT00501644|Drug|Interferon Gamma|0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle).
12012180|NCT00501631|Drug|VIVITROL 380 mg|Administered via IM injection once every 4 weeks.
12012181|NCT00501631|Drug|Placebo for VIVITROL 380 mg|Administered via IM injection once every 4 weeks.
12012182|NCT00501618|Drug|Fazaclo|single-arm
12012183|NCT00501605|Drug|AZD2171|
12012184|NCT00501592|Drug|INT-747|25 mg by mouth once daily, 50 mg by mouth once daily
12012185|NCT00501592|Drug|Placebo|Placebo
12012186|NCT00501579|Drug|Difluprednate|
12012187|NCT00501579|Drug|Prednisolone Acetate|
12012188|NCT00501566|Drug|satavaptan (SR121463B)|
12012189|NCT00501540|Drug|Lithium Carbonate|Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every 8 weeks.
12012190|NCT00501527|Biological|Immunotherapy with modified extract of P. pratense pollen|Sublingual (2 drops daily)
12012191|NCT00501527|Other|Placebo|Placebo 2 drops daily
12012192|NCT00501514|Drug|Growth hormone|
12012193|NCT00501501|Procedure|Cesarean section|
12012194|NCT00501501|Procedure|Vaginal delivery|
12012195|NCT00501488|Drug|rosiglitazone|
12012196|NCT00501475|Drug|NAC Bicarbonate|
12012197|NCT00501462|Drug|GSK189075|single 250 mg dose of drug
12012198|NCT00501449|Behavioral|Questionnaire|Mailed packets including cover letter describing purpose of study, study questionnaire, and return envelope.
12012199|NCT00501410|Drug|5-FU|2400 mg/m^2 by vein over 46 Hours On Days 1 & 2.
12012200|NCT00501410|Drug|Cetuximab|Initial Dose = 400 mg/m^2 by vein, then 250 mg/m^2 Weekly On Days 1 & 8
12012201|NCT00501410|Drug|Dasatinib|Starting dose level: 100 mg by mouth daily on days 1-14.
12012202|NCT00501410|Drug|Leucovorin|400 mg/m^2 by vein on day 1.
12012203|NCT00501410|Drug|Oxaliplatin|85 mg/m^2 by vein on day 1.
12012204|NCT00501397|Drug|ketoconazole|
12012205|NCT00501397|Drug|GSK189075|
12012206|NCT00501384|Drug|satavaptan (SR121463B)|
12012207|NCT00501371|Drug|MCS|soft-gel capsule, 15 mg/cap., Qd, 12 weeks
12012208|NCT00501371|Drug|Placebo|soft-gel capsule, Qd, 12 weeks
12012209|NCT00501345|Drug|Aspirin|325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily
12012210|NCT00501332|Biological|Maxy-G34|Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.
12012211|NCT00501319|Behavioral|Interactive Voice Response (IVR)|Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months.
12012212|NCT00501319|Behavioral|Questionnaire|Questionnaires taking 20 minutes to complete.
12012213|NCT00501293|Drug|Methylphenidate Transdermal System|One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months
12012214|NCT00501280|Behavioral|Interview|Interview by telephone or on-site in language of choice (English or Spanish), 60 to 70 minutes to complete the mother's and the child participants' questionnaires
12012215|NCT00501267|Drug|solabegron and oxybutynin|
12012216|NCT00501254|Drug|Slow release acetyl salicylic acid|
12012217|NCT00501254|Behavioral|Antithrombotic effect|
12012218|NCT00501241|Drug|ATI-7505|Tablet,placebo, BID
12012219|NCT00501241|Drug|ATI-7505|ATI-7505 20 mg BID for 4 weeks
12012220|NCT00501241|Drug|ATI-7505|tablet, 40 mg, BID, $ weeks
12012221|NCT00501241|Drug|ATI-7505|80 mg ATI-7505, BID for 4 weeks
12012222|NCT00501241|Drug|ATI-7505|120 mg ATI-7505, BID, for 4 weeks
12012223|NCT00501228|Drug|Filgrastim|5 mg/kg ID Once Daily x 1 Week
12012224|NCT00501215|Procedure|Parathyroid Surgery|Parathyroid surgery 1-3 weeks after the first PSG.
12012225|NCT00501215|Behavioral|Telephone Interview|Interview about sleep quality lasting 15-20 minutes.
12012226|NCT00501215|Procedure|Parathyroid Surgery|Parathyroid surgery after completing the second PSG and after the study participation ends.
12012227|NCT00501215|Behavioral|Polysomnography (PSG)|"2 overnight sleep tests
~Group 1: First PSG 1-3 weeks before surgery + Second PSG 6-8 weeks after surgery
~Group 2: First PSG 1-3 weeks before phone interview + Second PSG 6-8 weeks after phone interview"
12012228|NCT00501202|Drug|placebo|twice daily for 4 weeks
12012229|NCT00501202|Drug|RWJ-333369 (carisbamate)|200 mg tablet twice daily for 4 weeks
12012230|NCT00501189|Biological|human papillomavirus vaccine L1, type 6,11,16,18|Subjects are those getting gradasil vaccination already. This is really not an intervention
12012231|NCT00501176|Procedure|Plastic and metalic stent inserion|Patient randomizes to metal or plastic insertion prior to Whipple procedure
12012232|NCT00501150|Drug|linezolid|
12012233|NCT00501137|Biological|HPV (Human Papillomavirus) Vaccine|HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
12012234|NCT00501124|Drug|Clevudine|
12012235|NCT00501124|Biological|Purified hepatitis B surface antigen|
12012236|NCT00501111|Drug|AZD3480|3 oral doses
12012237|NCT00501111|Drug|Donepezil|
12012238|NCT00501098|Drug|Caspofungin|"Patients will receive caspofungin, starting from the first day of induction chemotherapy for leukemia, as a single daily dose intravenously at the dosage of 70 mg q.d. and followed by 50 mg q.d. thereafter until documentation of complete hematologic remission after the first induction cycle or of leukemia persistence after one cycle of induction and one cycle of salvage chemotherapy.
~No stratification is planned."
12012239|NCT00501085|Device|LAP-BAND AP Adjustable Gastric Banding System|Reduction of food intake due to creation of smaller stomach pouch.
12012240|NCT00501072|Device|Real-Time Continuous Glucose monitoring System (RT-CGMS)|
12012241|NCT00501059|Drug|Aspirin (Acetylsalicylic acid, BAYE4465)|100mg enteric coated Aspirin, taken daily
12012242|NCT00501059|Drug|Placebo|Placebo, taken daily
12012243|NCT00501046|Drug|Placebo|9g /day (3 times a day)
12012244|NCT00501046|Drug|AST-120|9g /day (3 times a day)
12012245|NCT00501033|Device|Mechanical induction of labor|
12012246|NCT00501033|Device|Double Balloon|
12012247|NCT00501033|Device|Foley Catheter|
12012248|NCT00501020|Drug|Rosiglitazone|
12012249|NCT00500994|Device|MRI|The imaging study will use a block design to (i) optimize amygdala activation to emotionally balanced images, (ii) to optimize analysis of PPI and (iii) to optimize the go/notask design. G. T2- sensitive functional images will be obtained on a MRI system with a 1.5 Tesla superconducting magnet and a standard head coil. An echo planar image sequence (TR=2500msec, TE=33 msec, 90 flip angle) with 30 contiguous 2mm thick coronal oblique slices with 1 mm interslice gap centered over the amygdala, tilted 30 to the anterior, to improve susceptibility artifact. Three dimensional anatomical images will be taken for the co-registration of the functional images.
12012250|NCT00500981|Procedure|Volume challenge|
12012251|NCT00500981|Procedure|Ultrasound evaluation of internal jugular vein|
12012252|NCT00500968|Procedure|stent|ERCP guided stent insertion before transection of the gland
12012253|NCT00500968|Procedure|Distal pancreatectomy|conventional distal pancreatectomy
12012254|NCT00500955|Drug|Rosiglitazone|
12012255|NCT00500942|Behavioral|Questionnaire|Questionnaires about the pain level experienced during and after standard procedures are performed in the IR.
12012256|NCT00500929|Drug|CMI X-11S|
12012257|NCT00500916|Device|ProSeal LMA|GEB vs digital vs introducer tool
12012258|NCT00500903|Drug|Alisertib|Alisertib (MLN8237) will be supplied in capsules of 5 or 25 mg and will be given on an empty stomach, with patients remaining nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose. Each dose will be given by mouth with 8 ounces of water for 7 to 21 consecutive days. A 14-day recovery period will follow each dosing period regardless of its duration.
12012259|NCT00500890|Drug|Carboplatin|350 mg/m^2 by vein, Over 2 Hours x 2 Days
12012260|NCT00500890|Drug|Cyclophosphamide|1 g/m^2 by vein, Over 1 Hour x 2 Days
12012261|NCT00500890|Drug|Etoposide|100 mg/m^2 by vein, Over 1 Hour x 5 Days
12012262|NCT00500890|Drug|Vincristine|1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5
12012263|NCT00500890|Radiation|Radiation Therapy|Radiation treatment over a period of about 6 weeks.
12012264|NCT00500877|Behavioral|Mood Management Phone Counseling for Smoking Cessation|Phone counseling addressed mood management and smoking cessation
12012265|NCT00500864|Drug|Magnesium Sulfate 2 grams|
12012266|NCT00500851|Device|Electromagnetic imaging for jejunal tube placement (CORTRAK)|Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)
12012267|NCT00500851|Device|Endoscopy|Endoscopic placement of jejunal feeding tubes
12012268|NCT00500838|Device|Transthoracic Impedance|Impedance measures will be automatically collected via the device
12012269|NCT00500825|Procedure|Measurement of Resting Energy Expenditure|Non-invasive measurement of Resting Energy Expenditure
12012270|NCT00500812|Drug|Cethrin|
12012271|NCT00500786|Biological|CYT006-AngQb|
12012272|NCT00500760|Drug|Cisplatin|Administered intravenously (IV; in a vein)
12012273|NCT00500760|Radiation|Standard Fractionation Radiotherapy|70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)
12012274|NCT00500760|Drug|Panitumumab|Administered intravenously
12012275|NCT00500747|Biological|HCV E1E2/MF59|The investigational vaccine contains envelope glycoproteins gpE1 and gpE2 and the adjuvant, MF59. MF59 is a sterile oil-in-water emulsion in a citrate buffer, which comprises 50 percent of the vaccine. The antigen and adjuvant are combined prior to the injection. The volume to be administered is 0.5 mL for all vaccine dose levels. The vaccine has a milky white opacity. Vaccine dosages: 4 mcg, 20 mcg and 100 mcg.
12012276|NCT00500747|Drug|Placebo|Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.
12012277|NCT00500734|Procedure|Blood Sample|One time blood draw of 2 teaspoons.
12012278|NCT00500721|Drug|HCV-796|HCV-796 500mg BID x 14 days
12012279|NCT00500721|Drug|Desipramine|"Period 1: Single oral dose of desipramine (50 mg) on day 1. No test article administration on days 2 to 6.
~Period 2: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 1 to 9.
~Period 3: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 10 to 14 and a single oral dose of desipramine (50 mg) on day 10."
12012280|NCT00500695|Behavioral|Motivational Interviewing|Motivational Interviewing
12012281|NCT00500695|Behavioral|Psychoeducation|Psychoeducation
12012282|NCT00500682|Drug|Placebo|9g /day (3 times a day)
12012283|NCT00500682|Drug|AST-120|9g /day (3 times a day)
12012284|NCT00500669|Drug|Betadine|Topically
12012285|NCT00500656|Drug|Icatibant|Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist.
12012286|NCT00500656|Drug|Tranexamic Acid|over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE.
12012287|NCT00500656|Drug|Oral Placebo|hard capsule matched to tranexamic acid
12012288|NCT00500656|Drug|S.C. Placebo|solution for injection, matched to icatibant for injection
12012289|NCT00500630|Device|Body fixed 3D sensors|
12012290|NCT00500617|Diagnostic Test|Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
12012291|NCT00500604|Drug|Irbesartan/hydrochlorothiazide|150/12.5mg tablet and 300/12.5mg tablet
12012292|NCT00500604|Drug|Valsartan/hydrochlorothiazide|80/12.5mg tablet and 160/12.5mg tablet
12012293|NCT00500604|Drug|Hydrochlorothiazide|12.5 mg administered orally, once daily in the morning
12012294|NCT00500591|Behavioral|Questionnaire|Questionnaire regarding weight history, gynecologic, and medical history, lasting about 30 minutes.
12012295|NCT00500578|Drug|Ribavirin|Arm 1 = 6 Grams Over 18 hours Every 24 Hours
12012296|NCT00500578|Drug|Ribavirin|Arm 2 = 2 Grams Over 3 Hours Every 8 Hours.
12012297|NCT00500565|Drug|Saline|On-Q Pain Pump filled with Saline. The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.
12012298|NCT00500565|Drug|Bupivicaine|On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours. The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.
12012299|NCT00500552|Drug|Perhexiline/Placebo|
12012300|NCT00500539|Drug|omalizumab|The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.
12012301|NCT00500526|Other|Singing practice|
12012302|NCT00500526|Other|Singing classes|
12012303|NCT00500526|Other|Hand craft classes|
12012304|NCT00500513|Procedure|CT Scans|CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.
12012305|NCT00500513|Procedure|Implanted markers|Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope
12012306|NCT00500513|Radiation|Radiation Treatment (RT)|Radiotherapy incorporating respiratory treatment delivery
12012307|NCT00500500|Drug|EGb 761® (Tanakan®)|
12012308|NCT00500487|Behavioral|Affect Management|12-session group intervention including affect management training as well as sexual health skills training.
12012309|NCT00500487|Behavioral|HIV Prevention Skills|12-session group intervention including sexual health skills training.
12012310|NCT00500487|Behavioral|General Health Promotion|12-session group intervention including health information on a variety of health topics.
12012311|NCT00500474|Procedure|endolymphatic sac drainage with steroids|
12012312|NCT00500461|Drug|GSK233705|GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.
12012313|NCT00500448|Device|Electrical Stimulation|Electrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks
12012314|NCT00500435|Procedure|Extraperitoneal Laparoscopic Lymphadenectomy|Laparoscope used to find and remove para aortic lymph nodes in abdomen.
12012315|NCT00500422|Drug|Doxil|Starting dose of 20 mg/m^2 IV over 2 hours on Day 1, 21 day cycle
12012316|NCT00500422|Drug|Gemcitabine|500 mg/m^2 IV over 30 minutes on Days 1 and 8, 21 day cycle
12012317|NCT00500422|Drug|Velcade|Starting dose of 0.7 mg/m^2 IV on Days 1 and 8 of first 21 day cycle; increased dose of 1.0 to 1.3 on Days 1, 4, 8, and 11 of subsequent 21 day cycles
12012318|NCT00500409|Drug|Osteoform|Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days
12012319|NCT00500409|Drug|SHELCAL|Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days
12012320|NCT00500396|Procedure|Open-Sky Vitrectomy|Open-Sky vitrectomy with removal of the Tunica vasculosa lentis and retinal reattachment
12012321|NCT00500370|Drug|exenatide|subcutaneous injection (5mcg or 10mcg), twice a day
12012322|NCT00500370|Drug|placebo|subcutaneous injection (equivalent volume to active dose), twice a day
12012323|NCT00500357|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose 13vPnC
12012324|NCT00500344|Drug|Lucentis (ranibizumab)|intravitreal injection
12012325|NCT00500331|Drug|GSK189075|Experimental Drug
12012326|NCT00500331|Drug|pioglitazone|Active Control
12012327|NCT00500331|Other|Placebo|Placebo Comparator
12012328|NCT00500318|Drug|Aclidinium Bromide|Aclidinium Bromide, 200μg. Once daily oral inhalation.
12012329|NCT00500318|Drug|Placebo|Dose matched placebo, once daily oral inhalation.
12012330|NCT00500305|Procedure|Withhold standard INDO dose if BNP < 100 pg/ml|
12012331|NCT00500292|Drug|Vandetanib|once daily oral tablet two dose strengths
12012332|NCT00500292|Drug|FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid|intravenous infusion
12012333|NCT00500279|Drug|Celecoxib|
12012334|NCT00500253|Device|exhaled nitric oxide measurement|exhaled nitric oxide measurement
12012335|NCT00500253|Procedure|bronchial hyperresponsiveness with methacholine (PC20M)|bronchial hyperresponsiveness with methacholine (PC20M)
12012336|NCT00500253|Procedure|symptom score diary (according to 2007 GINA guidelines)|symptom score diary (according to 2007 GINA guidelines)
12012337|NCT00500240|Drug|Insulin Glargine|Use of human insulin glargine for slow decrease of blood sugar level over 24 hours.
12012338|NCT00500240|Drug|Insulin Aspart|Use of human insulin aspart for rapid lowering of the blood glucose level over 24 hours.
12012339|NCT00500214|Procedure|elective ilioinguinal nerve excision|
12012340|NCT00500201|Drug|SB- 773812 60 mg|SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
12012341|NCT00500201|Drug|SB- 773812 120 mg|SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
12012342|NCT00500201|Drug|Placebo|Placebo tablets will be administered orally by subjects.
12012343|NCT00500188|Drug|Imatinib Mesylate (Gleevec)|300 mg orally twice daily
12012344|NCT00500175|Device|TempTouchRM|
12012345|NCT00500175|Device|Offloading|
12012346|NCT00500162|Behavioral|Tri-Luma Maintenance regimen|
12012347|NCT00500149|Drug|Vyvanse (lisdexamfetamine dimesylate)|Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day).
12012348|NCT00500149|Drug|Placebo|Placebo
12012349|NCT00500136|Procedure|mortality salience|
12012350|NCT00500123|Procedure|Alpha-1 Antitrypsin Genotype|Home fingerstick testing for alpha-1 antitrypsin genotype
12012351|NCT00500110|Drug|Docetaxel|30 mg/m^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.
12012352|NCT00500110|Drug|Imatinib Mesylate|600 mg by mouth (PO) Daily x 42 Days.
12012353|NCT00500110|Drug|Leuprolide|Hormone injections given every other month or every 3 months, as determined by the doctor.
12012354|NCT00500110|Drug|Goserelin Acetate|Hormone injections given every other month or every 3 months, as determined by the doctor.
12012355|NCT00500097|Device|Digital retina image|
12012356|NCT00500097|Device|direct ophthalmoscopy|
12012357|NCT00500097|Procedure|comprehensive eye exam|
12012358|NCT00500084|Drug|Liprotamase|Administered orally
12012359|NCT00500071|Drug|Vyvanse (lisdexamfetamine dimesylate)|Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.
12012360|NCT00500058|Drug|SB-485232|SB-485232 for injection, 7 mg/vial, will be available as a lyophilized cake. It will be reconstituted with 1.4 mL of water for injection. Each vial of this drug product is a clear, colorless solution containing 5 mg/mL of SB-485232.
12012361|NCT00500058|Drug|Rituximab|Rituximab 375 mg/m^2 will be administered by IV infusion.
12012362|NCT00500045|Drug|nicotinic acid|niacin 1500 mg po qd
12012363|NCT00500032|Procedure|blood draw|Blood draw from subjects previously vaccinated in 6108A1-500 trial
12012364|NCT00500006|Drug|MK0457|"Schedule A: 5-day continuous IV infusion every 28 days MK0457 (dose determined by height and weight). Starting dose = 20 mg/m2/hour titrating up to 33 mg/m2/hour.
~Schedule B: 6-hr IV infusion every 14 days MK0457 (dose determined by height and weight). Starting dose = 64 mg/m2/hour titrating up to 216 mg/m2/hour."
12012365|NCT00500006|Drug|dasatinib|Oral dasatinib 70 mg b.i.d. tablets twice daily.
12012366|NCT00499993|Drug|lanreotide (Autogel formulation), duration of treatment 46-48 weeks|
12012367|NCT00499967|Drug|GS-9191 ointment|GS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
12012368|NCT00499967|Drug|GS-9191|GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
12012369|NCT00499967|Drug|Placebo|Placebo matching GS-9191 ointment
12012370|NCT00499954|Procedure|Microdialysis|
12012371|NCT00499954|Device|Guardian RT|
12012372|NCT00499954|Device|Glucoday S|
12012373|NCT00499928|Drug|SB-751689|
12012789|NCT00497237|Drug|Fluticasone plus salmeterol fixed combination|diskus 250/50
12012374|NCT00499915|Behavioral|Secondhand Smoke Reduction and Smoking Cessation Counseling|A secondhand smoke reduction program, including smoking cessation counseling (if appropriate), and feedback about the children's cotinine levels will be implemented using principles of Motivational Interviewing.
12012375|NCT00499915|Behavioral|Asthma Education|Asthma education will be provided at NICU discharge.
12012376|NCT00499902|Drug|alfimeprase|Alfimeprase will be given as a single bolus of 1mg/2mL, or a split bolus of 5mg/2mL or 10mg/2mL in a three-tier dose escalation format. The 5mg and 10mg doses will be administered as split doses with 1/2 of the total dose given initially and 1/2 of the total dose given 30 minutes after the initial dose.
12012377|NCT00499889|Drug|Imatinib Mesylate|400 mg by mouth twice daily for 9 Days
12012378|NCT00499889|Drug|Fludarabine (Fludara)|40 mg/m^2 by vein daily for 4 Days
12012379|NCT00499889|Drug|Busulfan|130 mg/m^2 by vein daily for 2 Days
12012380|NCT00499889|Drug|Antithymocyte Globulin (ATG)|2.5 mg/kg by vein daily for 3 Days
12012381|NCT00499889|Drug|Tacrolimus|Tacrolimus levels maintained between 5-15 ng/dl, first as continuous IV infusion, and converted to oral every 12 hour dosing as tolerated. Starting day -2 until day 180.
12012382|NCT00499889|Drug|Methotrexate|5 mg/m2 on days 1, 3, 6 and 11.
12012383|NCT00499889|Procedure|Donor lymphocyte infusion (DLI)|Infusion of lymphocytes from the original bone marrow donor by vein if relapse after >4 weeks of imatinib.
12012384|NCT00499889|Procedure|Stem Cell Transplant|Infusion of donor bone marrow or blood stem cells by vein over approximately one hour on day 0.
12012385|NCT00499876|Drug|mefloquine|250mg weekly PO for 6 months
12012386|NCT00499876|Other|placebo|1 tablet weekly PO for 6 months
12012387|NCT00499863|Drug|methylphenidate transdermal system|dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
12012388|NCT00499863|Drug|Placebo|Placebo patch
12012389|NCT00499850|Drug|ZD6474 (vandetanib)|once daily oral dose
12012390|NCT00499850|Drug|5-Fluorouracil|intravenous infusion
12012391|NCT00499850|Drug|Leucovorin|intravenous infusion
12012392|NCT00499850|Drug|Oxaliplatin|intravenous infusion
12012393|NCT00499837|Drug|Aerosolized, human, plasma-derived Alpha-1 Antitrypsin|
12012394|NCT00500266|Biological|13-valent Pneumococcal Conjugate Vaccine (13vPnC)|
12012395|NCT00499824|Behavioral|Education of general practitioners on the IDF-WPR guidelines|"The intervention will comprise an educational program on the guidelines for GPs, and will be carried out by the national coordinating centre in each country, based on a template provided by the international coordinating centre (International Diabetes Institute, Australia). This will involve:
~an initial educational symposium and a follow-up continuing medical education symposium at 3 months; paper or electronic reminders of the guidelines sent to GPs every 3 months; desktop reminder cards with guideline algorithms; insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the study nurse; provision of each patient with a diabetes passport to be held by the patient."
12012396|NCT00499811|Drug|vorinostat|Given orally
12012397|NCT00499811|Other|pharmacological study|Correlative studies
12012398|NCT00499759|Behavioral|Resting vitals|The fitness assessments will include the assessment of resting vitals including, blood pressure, heart rate, and hemoglobin saturation (pulse oximeter).
12012399|NCT00499759|Behavioral|Body Composition|Body composition and body circumference measurements (anthropometry) will be the only assessments performed multiple times during the study to monitor possible changes in the body composition and swelling of the patients. Body composition analyses will be performed via skinfold measurements following generalized three-site skinfold equations for male and females as recommended by the ACSM, 2005 and via the utilization of a bioelectrical impedance body fat analyzer device.
12012400|NCT00499759|Behavioral|Timed Get-up and Go test (TGUG).|"The functional mobility of the subjects that will participate in the study will be assessed through the Timed Get-up and Go test (TGUG). The administration of the TGUG includes measuring a distance of 3 meters from the legs of a straight-backed armchair with a seat height of approximately 46 centimeters. The subject will be asked to sit with the back against the chair with the arms on the arm rests. When instructed to begin the test (on the command Go), the subject will have to stand upright then walk at a normal walking pace toward the 3 meters mark placed on the ground, turn around, return to the chair, and sit down. The stopwatch was started on the word Go and stopped when the subject gets back to starting position."
12012401|NCT00499759|Behavioral|Cardiorespiratory assessment|The cardiorespiratory assessment will be performed on a recumbent cycle ergometer. Subjects will be asked to cycle at a target submaximal intensity of 60 % of their percentage of heart rate range until a RPE (Rate of Perceived Exertion) of 7 is reached on the modified Borg Scale or when the subject requests termination. The Borg modified RPE scale is a scale ranging from 0 to 11 where 0 means no exertion at all and 11 equals to an exertion of absolute maximum. The total time cycling and heart rate (HR) at the end of the test will be recorded immediately after the test is completed.
12012402|NCT00499759|Behavioral|Handgrip evaluation|Handgrip strength will be tested using a handgrip dynamometer. Subjects will be asked to stand and hold the handgrip dynamometer in one hand lined with the forearm that will be placed beside the body. Maximum grip strength is then determined without swinging the arm and by squeezing the handgrip dynamometer as hard as possible using one brief maximal contraction with no extraneous body movement. The test will be administered three times for each hand with a one-minute rest in between trials. The best score within the three trials for each arm will be the one that will be used for analysis.
12012403|NCT00499759|Behavioral|Dynamic muscular endurance|Subjects will be asked to squat to a 75 degree knee angle with moderate speed, pressing back against the ball at all times. This is repeated as many repetitions as it takes for the subject to report an RPE of 7 or wishes to stop. The second test is the biceps curl exercise. The biceps curls exercise test will follow a protocol developed at the Rocky Mountain Cancer Rehabilitation Institute (RMCRI), Greeley, Colorado. The protocol involves the administration of the exercise biceps curls, done with dumbbells. Subjects will be asked to perform as many repetitions as possible during an alternated biceps curl exercise using a percentage of their body weight as resistance.
12012404|NCT00499746|Drug|tramadol|oral dose, once per day
12012405|NCT00499746|Drug|placebo|oral dose, once per day
12012406|NCT00499746|Drug|Hydromorphone|oral dose, once per day
12012407|NCT00499746|Drug|Methylphenidate|oral dose, once per day
12012870|NCT00496587|Drug|Bevacizumab|10 mg/kg By Vein On Days 1 and 15.
12012408|NCT00499733|Drug|cyclophosphamide|500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
12012409|NCT00499733|Device|Cryoablation|Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
12012410|NCT00499720|Drug|Aztreonam Lysine for Inhalation|75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
12012411|NCT00499707|Drug|rosiglitazone maleate/metformin hydrochloride|rosiglitazone maleate/metformin hydrochloride
12012412|NCT00499694|Biological|bevacizumab|10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
12012413|NCT00499694|Drug|satraplatin|80 mg/m(2), Orally, Days 1-5, every 35 days
12012414|NCT00499681|Drug|lapatinib ditosylate|Given once daily, 1500mg, for 2 weeks; Given once daily, 1500mg, for 14 weeks in Arm II
12012415|NCT00499681|Drug|letrozole|Given once daily, 2.5mg, for 2 weeks; Given once daily, 2.5mg, for 14 weeks
12012416|NCT00499681|Other|placebo|Given once daily for 2 weeks
12012417|NCT00499668|Drug|aprepitant|125 mg orally for 7 days
12012418|NCT00499668|Drug|ondansetron hydrochloride|24 mg orally for 7 days
12012419|NCT00499655|Drug|erlotinib hydrochloride|Given orally
12012420|NCT00499655|Drug|celecoxib|Given orally
12012421|NCT00499655|Other|placebo|Given orally
12012422|NCT00499655|Other|laboratory biomarker analysis|Correlative studies
12012423|NCT00499655|Other|immunohistochemistry staining method|Correlative studies
12012424|NCT00499655|Genetic|fluorescence in situ hybridization|Correlative studies
12012425|NCT00499655|Genetic|mutation analysis|Correlative studies
12012426|NCT00499655|Genetic|protein expression analysis|Correlative studies
12012427|NCT00499655|Genetic|gene expression analysis|Correlative studies
12012428|NCT00499642|Drug|Lecozotan SR|
12012429|NCT00499642|Drug|Moxifloxacin|
12012430|NCT00499629|Drug|FXR 450|capsule, single oral doses from 10 mg to 450 mg
12012431|NCT00499629|Drug|placebo|capsule similar to active drug
12012432|NCT00499616|Drug|carboplatin|Given IV
12012433|NCT00499616|Drug|cyclophosphamide|Given IV
12012434|NCT00499616|Drug|doxorubicin hydrochloride|Given IV
12012435|NCT00499616|Drug|etoposide|Given orally
12012436|NCT00499616|Drug|topotecan hydrochloride|Given IV
12012437|NCT00499616|Drug|Isotretinoin|Given orally
12012438|NCT00499616|Procedure|Surgery|With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.
12012439|NCT00499616|Drug|Filgrastim|Administered subcutaneously or by IV beginning 24-48 hrs after the last dose of chemotherapy & continuing daily until the ANC is greater than or equal to 1500 following the myelosuppressive nadir . Supportive care given to stimulate neutrophil recovery following chemotherapy and to shorten the duration of chemotherapy-induced neutropenia. On ANBL0531 the use of filgrastim was required for patients less than 60 days of age and was optional for other patients.
12012440|NCT00499603|Drug|Paclitaxel|80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
12012441|NCT00499603|Drug|5-Fluorouracil|500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
12012442|NCT00499603|Drug|Epirubicin|100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
12012443|NCT00499603|Drug|Cyclophosphamide|500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
12012444|NCT00499603|Drug|RAD001|30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
12012445|NCT00499590|Drug|bevasiranib|Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
12012446|NCT00499590|Drug|ranibizumab|Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
12012447|NCT00499577|Biological|CMV pp65 peptide|Given intramuscularly
12012448|NCT00499577|Biological|hTERT I540/R572Y/D988Y multipeptide vaccine|Given subcutaneously
12012449|NCT00499577|Biological|pneumococcal polyvalent vaccine|Given intramuscularly
12012450|NCT00499577|Biological|survivin Sur1M2 peptide vaccine|Given subcutaneously
12012451|NCT00499551|Device|Iontophoresis second generation Eyegate II device|
12012452|NCT00499538|Drug|SKI-606|
12012453|NCT00499525|Drug|paclitaxel|given IV
12012454|NCT00499525|Drug|sorafenib tosylate|given orallly
12012455|NCT00499525|Other|placebo|given orally
12012456|NCT00499512|Behavioral|Questionnaire|Questionnaires that ask questions about religion, spirituality, and decisions about treatment at three points (at time of diagnosis, end of primary chemotherapy, and one year later).
12012457|NCT00499499|Drug|E7107|E7107 will be administered as an intravenous infusion over 30 minutes at a starting dose of 0.6 mg/m^2 to the first cohort of patients. The same dose will be given on Days 1 and 8 of a 21-day cycle. Dose escalation will not occur until the maximum tolerated dose is reached. The selection of subsequent dose levels will be performed according to an accelerated design.
12012458|NCT00499486|Drug|sirolimus|Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
12012459|NCT00499473|Drug|sunitinib malate|Given orally
12012460|NCT00499473|Other|pharmacological study|Correlative studies
12012461|NCT00499460|Dietary Supplement|garlic powder tablets|Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet
12012462|NCT00499460|Drug|oxycodone|Single administration of three 5-mg oxycodone tablets or a 15-mg dose
12012463|NCT00499447|Procedure|radiofrequency ablation|
12012464|NCT00499447|Radiation|radiation therapy|
12012465|NCT00499421|Procedure|Computed Tomography (CT) Scan|CT scan of the prostate three times a week, just before the delivery of radiation.
12012466|NCT00499408|Dietary Supplement|Vitamin D|Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)
12012467|NCT00499408|Dietary Supplement|soy|Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).
12012682|NCT00498225|Drug|TS-1|TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
12012468|NCT00499395|Procedure|positron emission tomography|All patients will undergo pre RFA PET prior to ablation for intra and extrahepatic staging and to assess FDG avidity of the lesions. When evaluating patients with liver metastases, we routinely obtain a dedicated liver PET study (Liver View) after the whole body PET. Patients will undergo two post RFA PET scans as part of this project: PET # 1) within 32 hours after RFA. The patients having percutaneous RFA will undergo PET on the same day after the clinical studies at the PET facility are completed; this will be within 8 hours after RFA. In case of laparoscopic and intra-operative RFA, PET will be performed on the following day after the clinical studies are completed; this will be within 32 hours after RFA. PET # 2) on day seven after RFA
12012469|NCT00499395|Procedure|radiofrequency ablation|All patients will undergo pre RFA PET prior to ablation for intra and extrahepatic staging and to assess FDG avidity of the lesions. Patients will undergo two post RFA PET scans as part of this project: PET # 1) within 32 hours after RFA. The patients having percutaneous RFA will undergo PET on the same day after the clinical studies at the PET facility are completed; this will be within 8 hours after RFA. In case of laparoscopic and intra-operative RFA, PET will be performed on the following day after the clinical studies are completed; this will be within 32 hours after RFA. PET # 2) on day seven after RFA
12012470|NCT00499382|Procedure|Nuclear Medicine Cardiac Scan|Scan lasting 30 minutes while being hooked up to a heart monitor that takes pictures every time your heart beats.
12012471|NCT00499382|Procedure|PET/CT Cardiac Scan|Scan lasting 10-15 minutes and performed after the normally scheduled PET/CT scan.
12012472|NCT00499369|Drug|irinotecan hydrochloride|Given IV
12012473|NCT00499369|Drug|leucovorin calcium|Given IV
12012474|NCT00499369|Drug|fluorouracil|Given IV
12012475|NCT00499369|Biological|cetuximab|Given IV
12012476|NCT00499369|Biological|bevacizumab|Given IV
12012477|NCT00499356|Device|pressure reducing insole|
12012478|NCT00499356|Device|GlideSoft®|
12012479|NCT00499343|Drug|Etoposide|150 mg/m^2 given intravenously over 2 hours every 12 hours x 6 doses.
12012480|NCT00499343|Drug|G-CSF|Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
12012481|NCT00499343|Drug|GM-CSF|250 mcg/m^2 injection given every evening till the completion of apheresis.
12012482|NCT00499343|Drug|Isophosphamide|10 g/m^2 given intravenously continuous infusion over 72 hours.
12012483|NCT00499343|Drug|Rituximab|Days +1 (375 mg/m^2) and +8 (1000 mg/m^2) given intravenously.
12012484|NCT00499343|Procedure|Apheresis|Peripheral blood stem cell collection.
12012485|NCT00499330|Procedure|lobectomy|
12012486|NCT00499330|Procedure|segmentectomy or wedge resection|
12012487|NCT00499291|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12012488|NCT00499291|Procedure|gene expression analysis|
12012489|NCT00499291|Procedure|laboratory biomarker analysis|
12012490|NCT00499291|Procedure|pharmacological study|
12012491|NCT00499291|Procedure|polymerase chain reaction|
12012492|NCT00499278|Behavioral|Rehabilitation after joint replacement surgery|
12012493|NCT00499265|Drug|gemcitabine hydrochloride|1000 mg/m2 as 30 min i.v. infusion once weekly for 7/8 weeks and then every 3/4 weeks
12012494|NCT00499265|Drug|Serine Proteinase Inhibitor WX-671|oral, daily
12012495|NCT00499265|Drug|Serine Proteinase Inhibitor WX-671|oral, daily
12012496|NCT00499252|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|
12012497|NCT00499239|Drug|GS-9219|"GS-9219 Injection is a clear, and colorless to slightly yellow aqueous solution containing 4 mg/mL of GS 9219.
~GS 9219 will be administered via IV infusion over 30 minutes in 100 mL of normal saline solution, every 21 days."
12012498|NCT00499213|Procedure|Home Care Assisted Peritoneal Dialysis|
12012499|NCT00499200|Drug|SRA-444|
12012500|NCT00499187|Procedure|Blood Draws|A single whole blood sample was collected for genomic analysis.
12012501|NCT00499174|Procedure|conventional surgery|Radical prostatectomy
12012502|NCT00499174|Radiation|brachytherapy|high dose rate temporary seed implant; permanent seed implant.
12012503|NCT00499174|Radiation|external beam radiation therapy|3D conformal radiation therapy; intensity modulated radiation therapy.
12012504|NCT00499174|Procedure|Biopsies|Periodic repeat biopsies
12012505|NCT00499161|Behavioral|New model of nursing care|
12012506|NCT00499148|Other|herbal extract; root of woody shrub grown in India/Sri-Lanka|
12012507|NCT00499135|Other|Computed Tomography|Correlative studies
12012508|NCT00499135|Other|Fluorothymidine F-18|Correlative studies
12012509|NCT00499135|Other|Laboratory Biomarker Analysis|Correlative studies
12012510|NCT00499135|Other|Pharmacological Study|Correlative studies
12012511|NCT00499135|Other|Positron Emission Tomography|Correlative studies
12012512|NCT00499135|Drug|Sunitinib Malate|Given PO
12012513|NCT00499122|Drug|Cyclophosphamide|
12012514|NCT00499122|Drug|Docetaxel|
12012515|NCT00499122|Drug|Doxorubicin|
12012516|NCT00499122|Drug|NOV 002|
12012517|NCT00499109|Drug|Docetaxel|"GD Group: 40 mg/m^2 on days 1 and 8, every 21 days
~DCb Group: 75 mg/m^2 on day 1
~DV Group: 50 mg/m^2 on days 1 and 15, every 28 days"
12012518|NCT00499109|Drug|Vinorelbine|DV Group: 35 mg/m^2 on days 1 and 15
12012519|NCT00499109|Drug|Carboplatin|"GCb Group: Area under the curve (AUC) 5 on day 1, every 21 days
~DCb Group: AUC 6 on day 1, every 21 days
~Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed."
12012520|NCT00499109|Drug|Gemcitabine|"GCb Group: 1,250 mg/m^2 on days 1 and 8
~GD Group: 1,250 mg/m^2 on days 1 and 8
~Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed."
12012521|NCT00499096|Behavioral|Chronic care model for Bipolar Disorder|The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.
12012522|NCT00499083|Biological|therapeutic autologous dendritic cells|injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments. If, after a cycle(s) of chemotherapy, no tumor can be localized by ultrasound, the DCs will be injected where the tumor bed was localized by the clip or marker.
12012523|NCT00499083|Drug|aromatase inhibition therapy|Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor (AI) or those drugs in sequence as determined by the treating oncologist. Hormone therapy will be given for at least 5 years.
12012524|NCT00499083|Drug|cyclophosphamide|600 mg/m2 IV day 1 every 2 weeks for 4 cycles
12012525|NCT00499083|Drug|doxorubicin hydrochloride|60 mg/m2 IV day 1 every 2 weeks for 4 cycles
12012526|NCT00499083|Drug|paclitaxel|175 mg/m2 intravenously (IV) over at least 3 hours day 1 every 2 weeks for 4 cycles.
12012527|NCT00499083|Drug|tamoxifen citrate|Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor (AI) or those drugs in sequence as determined by the treating oncologist. Hormone therapy will be given for at least 5 years.
12012528|NCT00499083|Genetic|gene expression analysis|IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
12012529|NCT00499083|Genetic|protein expression analysis|Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration.
12012530|NCT00499083|Genetic|reverse transcriptase-polymerase chain reaction|delta Ct (quantitative real time- reverse transcription-polymerase chain reaction (qRT-PCR)) of COX-2 and VEGF will be divided into the upper or lower median and Fisher Exact test used to assess the difference in response.
12012531|NCT00499083|Other|immunoenzyme technique|"Estrogen and progesterone receptor, Her2/neu testing: Tumor biopsy material (preferably the initial diagnostic biopsy if tissue is available) will be examined by Immunohistochemistry (IHC) with appropriate controls for estrogen, progesterone receptors and Her2/neu. If the IHC is 2+ or in the indeterminate range, further testing of over-expression of Her2/neu by fluorescent in situ hybridization (FISH) will be done . If this has already been done and reported by the referring hospital, it will not be repeated. These tests are standard of care.
~CEA and Survivin testing: IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
~COX-2 and VEGF A , T cell and Dendritic Cells: Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration."
12012532|NCT00499083|Other|immunohistochemistry staining method|"Estrogen and progesterone receptor, Her2/neu testing: Tumor biopsy material (preferably the initial diagnostic biopsy if tissue is available) will be examined by Immunohistochemistry (IHC) with appropriate controls for estrogen, progesterone receptors and Her2/neu. If the IHC is 2+ or in the indeterminate range, further testing of over-expression of Her2/neu by fluorescent in situ hybridization (FISH) will be done . If this has already been done and reported by the referring hospital, it will not be repeated. These tests are standard of care.
~CEA and Survivin testing: IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
~COX-2 and VEGF A , T cell and Dendritic Cells: Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration."
12012533|NCT00499083|Other|laboratory biomarker analysis|"Estrogen and progesterone receptor, Her2/neu testing: Tumor biopsy material (preferably the initial diagnostic biopsy if tissue is available) will be examined by Immunohistochemistry (IHC) with appropriate controls for estrogen, progesterone receptors and Her2/neu. If the IHC is 2+ or in the indeterminate range, further testing of over-expression of Her2/neu by fluorescent in situ hybridization (FISH) will be done . If this has already been done and reported by the referring hospital, it will not be repeated. These tests are standard of care.
~CEA and Survivin testing: IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
~COX-2 and VEGF A , T cell and Dendritic Cells: Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration."
12012534|NCT00499083|Procedure|adjuvant therapy|Hormone manipulation Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor (AI) or those drugs in sequence as determined by the treating oncologist. Hormone therapy will be given for at least 5 years.
12012535|NCT00499083|Procedure|biopsy|Two tumor biopsies will be performed. The first tumor biopsy will be performed before apheresis for diagnostic purposes, and again after completion of the first four chemotherapy treatments. Patients will undergo local anesthesia with lidocaine and 1% epinephrine followed by 1-2 core biopsies of the breast primary and/or palpable axillary node with a 14 gauge, 16 cm. Bard needle or other similar needle. The procedure may be done under ultrasound guidance. If a metal clip or marker has not been previously placed in the tumor, it will be placed before treatment.
12012536|NCT00499083|Procedure|conventional surgery|Definitive breast surgery Surgery will occur two to four weeks after the last course of chemotherapy. Modified radical mastectomy or lumpectomy and standard axillary dissection could be performed and the specific procedure will be decided by the patient and physician team. If a sentinel node dissection was done prior to chemotherapy and was negative, no further node dissection is necessary. A standard node dissection will be necessary if no node assessment was done prior to chemotherapy or if the pre- chemotherapy sentinel node was positive.
12012537|NCT00499083|Procedure|neoadjuvant therapy|Chemotherapy: Paclitaxel (T) 175 mg/m2 intravenously (IV) over at least 3 hours day 1. Repeat every 2 weeks for 4 cycles. IT DCs will be injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
12012538|NCT00499083|Radiation|radiation therapy|Radiation therapy Radiation is started two to four weeks after surgery for all patients receiving lumpectomy and those patients after mastectomy that the physician feels chest wall radiation is warranted (example: T3 or T4 breast lesion, four or more axillary nodes etc.). The exact doses and methods of administration will be determined by the treating radiation therapist, but should be standard breast radiotherapy and not partial breast or investigational methods.
12012539|NCT00499070|Genetic|polymerase chain reaction|
12012683|NCT00498225|Drug|Gemcitabine|Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.
12012684|NCT00498212|Biological|1018 ISS-HBsAg-Single|Intramuscular (IM) injection at Day 0, Week 4 and Week 24
12012540|NCT00499070|Other|flow cytometry|For analyzing GPI deficient clones full blood will be analyzed by phenotyping using flowcytometry. For that purpose CD14, CD16 and CD24 expression will be evaluated in CD45 positive cells. Erythroid cells will be evaluated for CD55 and CD59 expression searching for clear populations with a lack of GPI-linked molecules. In addition, immunophenotyping using flowcytometry will be performed to evaluate which differentiation stages of the major hematopoietic lineages in BM and PB are associated with TCRVβ repertoire skewing. Comparison between BM and PB will identify which is the optimal compartment to analyze the responsible hematopoietic clones.
12012541|NCT00499070|Other|immunologic technique|
12012542|NCT00499070|Procedure|biopsy|
12012543|NCT00499057|Radiation|interstitial high dose-rate brachytherapy, PBI|Single arm study Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy.
12012544|NCT00499044|Other|CDR Computerized Cognitive Assessment System|Cognitive Drug Research Computerized Cognitive Assessment System consists of performance tasks that measure reaction time, numeric and spatial working memory, word and picture recall and recognition, and episodic secondary memory. CDR is a single, unified battery that can be stored and administered using a laptop computer.
12012545|NCT00499044|Other|MATRICS Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery measures functioning across various cognitive domains, such as attention, working memory (verbal and nonverbal), learning (verbal and visual), reasoning and problem solving, and social cognition. Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes.
12012546|NCT00499031|Biological|Cetuximab|Given IV
12012547|NCT00499018|Drug|Rituximab|375 mg/m2 day 1
12012548|NCT00499018|Drug|Ciclofosfamide|1200 mg/m2 day 1
12012549|NCT00499018|Drug|Doxorubicina|70 mg/m2 day 1
12012550|NCT00499018|Drug|Vincristina|1,4 mg/m2 (max 2 mg) day 1
12012551|NCT00499018|Drug|Prednisone|100 mg day g 1-5
12012552|NCT00499018|Drug|Pegfilgrastim|6 mg day +1
12012553|NCT00499018|Drug|Mitoxantrone|8 mg/m2/days 1-3
12012554|NCT00499018|Drug|ARA-C|2000 mg/m2/12h day 1 - 3
12012555|NCT00499018|Drug|Lenograstim|5 μg/Kg/days +2
12012556|NCT00499018|Drug|BCNU|300 mg/m2 day -7
12012557|NCT00499018|Drug|ARA-C|200 mg/m2/12 days -6,-5,-4,-3
12012558|NCT00499018|Drug|VP-16|100 mg/m2/12h days -6,-5,-4,-3
12012559|NCT00499018|Procedure|ASCT|PBSC Reinfusion
12012560|NCT00499018|Drug|Ciclofosfamide|750 mg/m2 day 1
12012561|NCT00499018|Drug|Doxorubicina|50 mg/m2 day 1
12012562|NCT00499018|Drug|Vincristina|1,4 mg/m2 (max 2 mg) day 1
12012563|NCT00499005|Drug|Syntommetrine and Carbetocin|Syntommetrine 1ml and Carbetocin 100microgram
12012564|NCT00499005|Drug|Syntommetrine and Carbetocin|Syntommetrine 1ml and Carbetocin 100micgrams
12012565|NCT00498992|Dietary Supplement|collagen/aloe vera/vitamin E/lidocaine topical hydrogel|
12012566|NCT00498979|Biological|recombinant interferon alfa-2b|recombinant interferon alfa-2b
12012567|NCT00498979|Drug|cisplatin|recombinant interferon alfa-2b
12012568|NCT00498979|Drug|sodium stibogluconate|sodium stibogluconate
12012569|NCT00498979|Drug|dacarbazine|dacarbazine
12012570|NCT00498979|Drug|vinblastine|vinblastine
12012571|NCT00498966|Drug|Perifosine|"Perifosine 100 mg PO Perifosine is supplied as a film-coated tablet containing 50 mg of active ingredient.
~Treatment will be administered on an outpatient basis in 28-day cycles. The patient dose for daily administration will be 100 mg qhs daily with food."
12012572|NCT00498953|Drug|carboplatin|
12012573|NCT00498953|Drug|cisplatin|
12012574|NCT00498953|Drug|docetaxel|
12012575|NCT00498953|Drug|fluorouracil|
12012576|NCT00498953|Drug|lapatinib ditosylate|
12012577|NCT00498953|Genetic|cytogenetic analysis|
12012578|NCT00498953|Genetic|fluorescence in situ hybridization|
12012579|NCT00498953|Genetic|in situ hybridization|
12012580|NCT00498953|Genetic|polymerase chain reaction|
12012581|NCT00498953|Genetic|reverse transcriptase-polymerase chain reaction|
12012582|NCT00498953|Other|immunohistochemistry staining method|
12012583|NCT00498953|Other|laboratory biomarker analysis|
12012584|NCT00498953|Procedure|conventional surgery|
12012585|NCT00498953|Procedure|neoadjuvant therapy|
12012586|NCT00498953|Radiation|fludeoxyglucose F 18|
12012587|NCT00498953|Radiation|radiation therapy|
12012588|NCT00498940|Device|Optimization Testing|Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.
12012589|NCT00498940|Device|Temporary Biventricular Pacing|Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate.
12012590|NCT00498927|Drug|temozolomide|
12012591|NCT00498927|Genetic|protein expression analysis|
12012592|NCT00498927|Genetic|reverse transcriptase-polymerase chain reaction|
12012593|NCT00498927|Other|diagnostic laboratory biomarker analysis|
12012594|NCT00498927|Other|immunoenzyme technique|
12012595|NCT00498914|Drug|YM155|Continuous IV infusion
12012596|NCT00498901|Drug|goserelin|
12012597|NCT00498901|Drug|letrozole|
12012598|NCT00498901|Drug|leuprolide acetate|
12012599|NCT00498901|Procedure|conventional surgery|
12012600|NCT00498888|Procedure|tolterodine|Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
12012601|NCT00498888|Procedure|bladder training|Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
12012602|NCT00498888|Procedure|pelvic floor muscle training|Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
12012603|NCT00498888|Procedure|pelvic floor rehabilitation|The Pelvic floor rehabilitation protocol based on bladder training protocol and PFMT and lifestyle advice and information about good bladder and bowel habits. Four visits in 3 months was made with pelvic floor physical therapist, who is trained in the procedure.
12012604|NCT00498875|Behavioral|Questionnaire|Questionnaire regarding mood, coping with cancer, how closely you follow your treatment schedule, your thoughts, your demographic information (such as age and race), and your medical history. If the answers to your questionnaire indicate that you may be depressed, you will be offered the intervention portion of the study.
12012605|NCT00498875|Behavioral|Depression Intervention|"Sessions given over 7 weeks and each lasting 30-45 minutes, that use cognitive-behavioral techniques."
12012606|NCT00498849|Device|CPAP|
12012607|NCT00498836|Drug|CP-4055|CP-4055 5mg/mL for infusion, dose: 200 mg/m2/day, schedule d1-5 q4w, 30 minutes IV infusion
12012608|NCT00498836|Drug|Sorafenib (Nexavar)|Sorafenib 200 mg tablets, dose: 400 mg/day, daily dosing
12012609|NCT00498810|Procedure|complete repair|
12012610|NCT00498810|Procedure|partial repair of the abdominal wall|
12012611|NCT00498797|Drug|Zactima (vandetanib)|
12012612|NCT00498797|Drug|Docetaxel|
12012613|NCT00498797|Drug|Prednisolone|
12012614|NCT00498784|Drug|Mirena|Mirena 52mg during 1 year
12012615|NCT00498771|Behavioral|Aquatic Exercise arm|Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
12012616|NCT00498758|Device|APOS System - biomechanical wedge shoe|
12012617|NCT00498745|Drug|neratinib|HKI-272
12012618|NCT00498732|Device|CPAP|CPAP treatment for 4 weeks
12012619|NCT00498719|Behavioral|Cognitive Training Program|Cognitive training sessions over a 4 to 6 month training period, each lasting about 2 hours.
12012620|NCT00498719|Other|Control Group|Standard educational support.
12012621|NCT00498706|Behavioral|Telephone-administered cognitive behavioral therapy (T-CBT)|Over 18 weeks, participants will receive eighteen 45-minute sessions of T-CBT administered by a therapist. Participants will undergo telephone-administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
12012622|NCT00498706|Behavioral|Face-to-face administered CBT (FtF-CBT)|Over 18 weeks, participants will receive eighteen 45-minute sessions of FtF-CBT administered by a therapist. Participants will undergo face-to-face administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
12012623|NCT00498680|Drug|Sildenafil, Vardenafil|Sildenafil 100mg, vardenafil 20mg, combination of both half dosage.
12012624|NCT00498680|Drug|Sildenafil|100mg
12012625|NCT00498680|Drug|Vardenafil|20mg
12012626|NCT00498680|Drug|Sildenafil & Vardenafil|50mg & 10 mg
12012627|NCT00498654|Biological|Ty800 (Salmonella typhi) Oral Vaccine|
12012628|NCT00498641|Procedure|computer program and patching|
12012629|NCT00498628|Drug|Quetiapine fumarate|Quetiapine fumarate- taken daily, for 12 weeks
12012630|NCT00498628|Other|Placebo|Placebo
12012631|NCT00498615|Drug|Fasudil|Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible sequences. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.
12012632|NCT00498602|Biological|ACC-001 + QS-21|IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
12012633|NCT00498602|Biological|QS-21|IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
12012634|NCT00498602|Other|Diluent: Phosphate Buffered Saline|IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
12012635|NCT00498602|Biological|ACC-001|IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
12012636|NCT00498589|Drug|methotrexate|25 mg per week IM or SC during 24 weeks
12012637|NCT00498589|Drug|placebo|one intramuscular injection per week
12012638|NCT00498563|Procedure|altitude exposure in hypobaric chamber|
12012639|NCT00498550|Drug|Clozapine|Clozapine up to 550mg per day
12012640|NCT00498550|Drug|Treatment as usual|Remain on pre-study antipsychotic treatment
12012641|NCT00498537|Drug|spironolactone|
12012642|NCT00498524|Device|ICD|Received an ICD
12012643|NCT00498524|Device|ICD|Have not received an ICD
12012644|NCT00498511|Procedure|upper gastrointestinal endoscopy, colonoscopy|
12012645|NCT00498485|Drug|Placebo|Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.
12012646|NCT00498485|Drug|Sodium Oxybate|Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.
12012647|NCT00498472|Procedure|Pre-discharge NT-ProBNP based treatment|"Discharge date, treatment and follow-up based also on the knowledge of NT-ProBNP levels measured at 2-3 days before discharge.
~Discharge may be postponed and medical treatment may be changed when NT-ProBNP is >3000 pg/ml. Changes in medical treatment will include the following: increase in the diuretic dose, association of a different diuretic; combination of digoxin therapy; increase in the dose of the renin-angiotensin inhibitor; association of an ARB; association of a nitrate; short course of i.v. diuretic, vasodilator and/or inotropic therapy."
12012648|NCT00498459|Behavioral|Physical activity|Physical promotion according to socio-ecological model Limitation of sedentary behaviour
12012649|NCT00498433|Drug|Aliskiren|300 mg tablet once daily
12012650|NCT00498433|Drug|Amlodipine|5 mg capsule once daily
12012651|NCT00498433|Drug|Placebo of Aliskiren|Matching placebo of aliskiren 300 mg tablet
12012652|NCT00498433|Drug|Placebo of amlodipine|Matching placebo of amlodipine 5 mg capsule
12012653|NCT00498407|Drug|CP-4055|CP-4055 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion
12012654|NCT00498394|Behavioral|Clinical diet trial|
12012655|NCT00498381|Device|CPAP|
12012656|NCT00498368|Drug|Intravenous Rituximab|"Rituximab Therapy [27 Patients]
~Rituximab 1 gm IV on Treatment Day 1
~Rituximab 1 gm IV on Treatment Day 15
~Rituximab 1 gm IV on Treatment Day 168
~Rituximab 1 gm IV on Treatment Day 182"
12012657|NCT00498368|Drug|ACE/ARB|ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg). Patients not attaining the target blood pressure with an ACE inhibitor or ARB alone should be treated with the combination of ACE inhibitor (ACEi) + ARB
12012658|NCT00498368|Dietary Supplement|Omega-3 Fatty Acid Fish Oil Supplement|Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
12012659|NCT00498355|Drug|Ranibizumab|0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.
12012660|NCT00498342|Drug|N-acetylcysteine|
12012661|NCT00498316|Procedure|Cord Blood Infusion|Cord blood transplantation performed on day 0.
12012662|NCT00498316|Drug|Busulfan|32 mg/m2 by vein as an outpatient before Day -14 or as an inpatient on Day -9, and AUC of 4,000 microMol.min-1 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are >1 and < 55 years old. Patients >55 but < 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
12012663|NCT00498316|Drug|Fludarabine|"10 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are >1 and < 55 years old. Patients >55 but < 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
~40 mg/m2 by vein on Days -6 to -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
~40 mg/m2 by vein on Days -5 to -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are >1 and < 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."
12012664|NCT00498316|Drug|Rituximab|375 mg/m2 by vein on Day -9 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
12012665|NCT00498316|Other|ATG|"1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
~1.25 mg/kg by vein on Day -3 and 1.75 mg/kg by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are >1 and < 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."
12012666|NCT00498316|Drug|Cyclophosphamide|50 mg/kg by vein on Day -6 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
12012667|NCT00498316|Drug|Clofarabine|30 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are >1 and < 55 years old. Patients >55 but < 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
12012668|NCT00498316|Radiation|Total Body Irradiation (TBI)|200 cGy at 25 cGy/minute delivered on Day -3.
12012669|NCT00498316|Drug|Melphalan|140 mg/m2 by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are >1 and < 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.
12012670|NCT00498316|Drug|Tacrolimus|0.03 mg/kg by vein daily starting on D-2, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered around Day +180, if no GVHD is present.
12012671|NCT00498316|Drug|Mycophenolate Mofetil|1 gram by vein twice a day Days -3 through Day 100.
12012672|NCT00498316|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on day 0, and continuing until the absolute neutrophil count (ANC) is > 2.5 x 109/L.
12012673|NCT00498303|Biological|trivalent split influenza vaccine|
12012674|NCT00498290|Procedure|enhanced recovery after surgery (ERAS) protocol|An integrated protocol aims to allow patients to recover more quickly from major surgery, avoid medium-term sequelae of conventional postoperative care (e.g. decline in nutritional status and fatigue) and reduce health care costs by reducing hospital stay
12012675|NCT00498290|Procedure|control|normal recovery protocol as usually
12012676|NCT00498277|Procedure|Magnetic Resonance Imaging|One MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion.
12012677|NCT00498264|Behavioral|walking program, resistance muscular exercise|
12012678|NCT00498251|Drug|inhalation of salbutamol (5 mg)|
12012679|NCT00498251|Drug|ipratropium|
12012680|NCT00498238|Drug|Levothyroxine|
12012681|NCT00498225|Drug|Gemcitabine plus TS-1|Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
12012685|NCT00498212|Biological|1018 ISS-HBsAg-Double|Intramuscular (IM) injection at Day 0, Week 4 and Week 24
12012686|NCT00498199|Procedure|visual tests|
12012687|NCT00498186|Drug|Rotigotine|"Rotigotine transdermal patches once daily:
~2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)"
12012688|NCT00498173|Drug|Atomoxetine|Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.
12012689|NCT00498173|Drug|Placebo|Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.
12012690|NCT00498160|Biological|Enriched Hematopoetic Stem Cell Infusion|Enriched Hematopoetic Stem Cell Infusion
12012691|NCT00498147|Other|ADEC Program|Interventions (managed diabetes care) employed by the ADEC Program include: diabetes education, nutrition care, individual and group counseling sessions, foot care, and insulin and oral diabetes medication adjustments with a signed medical directive. ADEC Diabetes Educators (Registered Dietitians and Registered Nurses) will use adult education principles throughout the education process and promote self-care by encouraging responsibility and promoting a positive attitude towards acceptance of diabetes. All patients will be encouraged to self-monitor their blood glucose at home. Team member collaboration and with other agencies to promote a total client care approach to diabetes management will be employed.
12012692|NCT00498134|Drug|Triple therapy for H. pylori infection|
12012693|NCT00498134|Drug|Cox-2 inhibitor|
12012694|NCT00498121|Device|PROCALCITONIN LEVEL|measuring PROCALCITONIN LEVEL
12012695|NCT00498108|Drug|Rotigotine|
12012696|NCT00498095|Procedure|Renal biopsy|
12012697|NCT00498069|Device|Harvest Smartprep2 BMAC System|injection of 40cc bmac
12012698|NCT00498069|Device|SmartPReP2 BMAC System|Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System
12012699|NCT00498069|Biological|placebo|injection of placebo into ischemic tissue of the lower extremity
12012700|NCT00498056|Biological|VRC-HIVDNA016-00-VP|DNA vaccine administered intramuscularly
12012701|NCT00498056|Biological|VRC-HIVADV014-00-VP|Adenovirus vaccine administered intramuscularly
12012702|NCT00498056|Biological|VRC-HIVDNA016-00-VP placebo|DNA vaccine placebo administered intramuscularly
12012703|NCT00498056|Biological|VRC-HIVADV014-00-VP placebo|Adenovirus vaccine placebo administered intramuscularly
12012704|NCT00498043|Drug|R-CHOP14 induction regimen|R-CHOP14 induction regimen
12012705|NCT00498043|Drug|R-ACVBP14 induction regimen|R-ACVBP14 induction regimen
12012706|NCT00498004|Drug|Quetiapine, Risperidone|The dose of quetiapine will be titrated over 4 days to 300mg/day (50mg at day 1, 100mg at day 2, 200mg at day 3 and 300mg at day 4) and thereafter flexible dose will be administered depending on the clinical state. The dose of risperidone will be titrated as following 2mg at day 1 and 4mg at day 4 and thereafter flexible dose will be administered depending on the clinical state. The dosage of drugs should be 400-800mg/day of quetiapine and 4-6mg/day of risperidone between 6 and 8 weeks of trial.
12012707|NCT00497991|Drug|AZD1152|
12012708|NCT00497978|Dietary Supplement|taurine|6 grams of taurine will be given each day in capsules, starting the day of admission till the sixth postoperative day
12012709|NCT00497978|Dietary Supplement|placebo|a similar amount of placebo will be given each day in capsules, starting the day of admission till the sixth postoperative day
12012710|NCT00497965|Procedure|Chiropractic Manipulation|
12012711|NCT00497965|Behavioral|Balance Exercises|
12012712|NCT00497952|Biological|hematopoetic stem cell infusion|Enriched hematopoietic stem cell infusion
12012713|NCT00497939|Drug|Saw palmetto and sanmiaoshan capsule|
12012714|NCT00497926|Biological|Enriched Hematopoietic Stem Cell Infusion|Enriched Hematopoietic Stem Cell Infusion
12012715|NCT00497913|Drug|NaCl 0.9%|
12012716|NCT00497913|Drug|Botulinum Toxin A|
12012717|NCT00497900|Drug|Vitamin D|Daily vitamin D (cholecalciferol) tablets and rocaltrol
12012718|NCT00497874|Behavioral|Computer-tailored intervention|Stage-based manual and three computer-tailored reports
12012719|NCT00497861|Procedure|Activator Methods Chiropractic Technique|
12012720|NCT00497848|Behavioral|motivational interviewing|"An individual intervention building on the Motivational Interviewing by Miller and Rollnick. Several studies has proved effectiveness of this therapy form in improving drug compliance. Patients will be offered individual motivational therapy"
12012721|NCT00497848|Other|The System-Orientated Intervention|"Principles in this intervention come from Clinical Risk Managing and quality assurance. It focuses on daily problems in drug handling, including dropping out of drug therapy, by looking at the system as a whole.Some cases, where patients dropped out of drug therapy will be carefully analysed in order to identify week points in the system, and subsequently alter the instructions for drug therapy, information, reminders and so on."
12012722|NCT00497822|Procedure|Aerobic exercise training|
12012723|NCT00497809|Drug|AVI-014 versus Filgrastim|3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
12012724|NCT00497796|Drug|maribavir|100mg twice a day for 14 weeks.
12012725|NCT00497796|Drug|ganciclovir|1000mg three times per day for 14 weeks.
12012726|NCT00497783|Drug|Lactoserum|
12012727|NCT00497770|Drug|Pemetrexed|Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
12012728|NCT00497757|Biological|enriched hematopoetic stem cell infusion|Enriched Hematopoetic Stem Cell Infusion
12012729|NCT00497744|Drug|Intraperitoneal Cefepime|
12012730|NCT00497731|Drug|AZD1152|2-hour continuous intravenous infusion
12012731|NCT00497718|Procedure|Chiropractic Manipulation|
12012732|NCT00497692|Drug|Lactoserum|
12012733|NCT00497679|Drug|AZD1152|7-day continuous intravenous infusion
12012734|NCT00497666|Drug|Rosiglitasone (retrospective observation)|
12012735|NCT00497653|Drug|DCI|D-chiro-inositol 1200mg twicely daily for 6 weeks
12012736|NCT00497653|Drug|Placebo|Placebo, twice daily for 6 weeks
12012737|NCT00497640|Procedure|Artificial Neural Network|Use of a predicted optimal CPAP
12012738|NCT00497614|Drug|adalimumab|
12012788|NCT00497237|Drug|Beclomethasone plus formoterol fixed combination|100+6 pMDI
12012739|NCT00497601|Drug|Amphotericin B fat emulsion in visceral leishmaniasis|Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 & 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 & 5 mg/kg on day 1 & 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 & 2.5 mg/kg on day 1 & 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
12012740|NCT00497601|Drug|Amphotericin B fat emulsion|Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
12012741|NCT00497601|Drug|Amphotericin B in fat emulsion|Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
12012742|NCT00497588|Procedure|surgery|
12012743|NCT00497588|Radiation|radiotherapy|
12012744|NCT00497562|Drug|sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)|
12012745|NCT00497562|Drug|amitriptyline, fluoxetine and tramadol alone (control group)|
12012746|NCT00497549|Procedure|side-to-side stapled|5 cm of the mobilized stomach will be placed in the neck. Three interrupted sutures will be taken between the posterior wall of esophagus and anterior wall of stomach. A 1.5 cm gastrotomy will be made. Two stay sutures will then be taken, one at the anterior corner of esophagus and another between posterior corner of esophagus and the middle of the gastrotomy. The stapler device (Endopath, EZ45) will be introduced.The staple cartridge will then be rotated so that the posterior wall of the esophagus and the anterior wall of the stomach will align in a parallel manner and fire the stapler. A 16F nasogastric tube will be placed across the anastomosis and the anterior edges of the gastrotomy and open esophagus will be approximated with interrupted 3-0 silk.
12012747|NCT00497549|Procedure|hand sewn|A proper site on the anterior wall of stomach away from the stapled line approximately 2 cm below the highest point of the gastric conduit will be anastamosed to esophagus Posterior interrupted seromuscular sutures will be taken with 3-0 silk. The stomach will then be opened transversely (2.5 to 3 cm long). Interrupted stitches with full thickness of the stomach and esophagus will be placed to achieve mucosa to mucosa approximation. A 16F nasogastric tube will then be placed across the anastomosis into the intrathoracic stomach. The anterior wall of the anastomosis will be completed in a manner similar to posterior wall.
12012748|NCT00497536|Drug|Insulin Aspart (IAsp)|"IAsp 100 U.
~≈ bolus protocol: From 6 pm until 6 am
~• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
~From 8 am until 6 pm
~1 dose/h + 50 % s.c. (≈ bolus)."
12012749|NCT00497536|Drug|Insulin Aspart (IAsp).|"IAsp 100 U From 6 pm until 8 am
~• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
~From 8 am until 6 pm 50 % increase of basal rate"
12012750|NCT00497536|Drug|Insulin Aspart (IAsp)|"IAsp 100 U From 6 pm until 8 am
~• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
~From 8 am until 6 pm 50 % increase of basal rate"
12012751|NCT00497523|Drug|Beclomethasone dipropionate|
12012752|NCT00497523|Drug|Beclomethasone dipropionate/Salbutamol combination|
12012753|NCT00497523|Drug|Salbutamol|
12012754|NCT00497510|Procedure|Chiropractic manipulation|
12012755|NCT00497497|Drug|bevacizumab|(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
12012756|NCT00497497|Drug|cetuximab|Intravenous repeating dose
12012757|NCT00497497|Drug|FOLFIRI regimen|Intravenous repeating dose
12012758|NCT00497497|Drug|irinotecan|Intravenous repeating dose
12012759|NCT00497497|Drug|PRO95780|Intravenous repeating dose
12012760|NCT00497484|Drug|recombinant human somatotropin|
12012761|NCT00497471|Drug|Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)|
12012762|NCT00497471|Drug|iron (2 mg/kg/daily)|
12012763|NCT00497458|Drug|Testosterone|testosterone 40 or 80 mg once a day
12012764|NCT00497445|Procedure|angioplasty / surgery|Percutaneous vascular intervention or surgery for peripheral arterial disease
12012765|NCT00497445|Procedure|Angioplasty / surgery and exercise therapy|Percutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy
12012766|NCT00497419|Procedure|fast track|
12012767|NCT00497406|Procedure|Salivary gland transfer|Retrograde flow method
12012768|NCT00497406|Procedure|Helical Tomotherapy treatment|total of 30 fractions
12012769|NCT00497393|Behavioral|Clinical Decision Unit|a dedicated 2-bed area to see patients and then rotate them back into the waiting room area for labs and diagnostic imaging.
12012770|NCT00497380|Dietary Supplement|Arginine|Oral nutritional supplement
12012771|NCT00497367|Device|Percutaneous Coronary Intervention (PCI) TAXUS Petal|TAXUS Petal, paclitaxel eluting stent
12012772|NCT00497354|Drug|Variation in volume of local anesthetic|
12012773|NCT00497354|Procedure|Ultrasound-guided interscalene brachial plexus block|
12012774|NCT00497341|Drug|cefuroxime|cefuroxime is administered at a dosage of 1.5 g before tourniquet inflation and release in experimental arm and only before tourniquet inflation in control arm
12012775|NCT00497341|Drug|placebo|cefuroxime 1.5 g IV before tourniquet inflation + placebo before tourniquet release + cefuroxime 1.5 g IV 6 h after surgery
12012776|NCT00497328|Drug|N-acetylcysteine|
12012777|NCT00497328|Drug|Sodium Bicarbonate|
12012778|NCT00497315|Drug|combination chemotherapy (pemetrexed + cisplatin)|pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
12012779|NCT00497315|Radiation|thoracic irradiation + pemetrexed|pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)
12012780|NCT00497302|Behavioral|RBT|Contingency management and behavioral counseling including motivational interviewing
12012781|NCT00497302|Behavioral|usual care|receives usual comprehensive care at Center for Addiction and Pregnancy
12012782|NCT00497289|Drug|Lipofundin MCT/LCT 20 %|daily i.v. infusion for up to 5 days
12012783|NCT00497289|Drug|Lipidem 20%|daily i.v. infusion for up to 5 days
12012784|NCT00497276|Procedure|placement of popliteal catheter|Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h
12012785|NCT00497263|Device|Niti CAR|
12012786|NCT00497250|Drug|Gefitinib|gefitinib 250 mg/day,PO concurrent with RT and 250 mg/day,PO for 60 days after the completion of RT.
12012787|NCT00497250|Device|Radiation Therapy|group 1.54Gy/27Fx concurrent with gefitinib group 2.56Gy/28Fx concurrent with gefitinib group 3.58Gy/29Fx concurrent with gefitinib group 4.60Gy/30Fx concurrent with gefitinib
12012790|NCT00497224|Drug|Erlotinib|Erlotinib starting at 150 mg PO (by mouth) daily. Dose may increase or decrease by the study doctor as per protocol (study plan).
12012791|NCT00497211|Procedure|Intracoronary mononuclear cell infusion|
12012792|NCT00497198|Drug|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
12012793|NCT00497198|Drug|Placebo of MCI-196 Tablet|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
12012794|NCT00497185|Behavioral|Mindfulness-Based Cognitive Therapy for Functional Disorders|"Mindfulness-based cognitive therapy: A manualized program will be delivered by two instructors who are experienced cognitive therapists in eight weekly 3½-hour group training sessions and one follow-up session after a month involving up to 12 patients with somatoform disorders. The patients must be willing and able to attend and devote up to 1 hour per day for homework.
~The therapy is compared with a group of controls receiving shared care defined as: Treatment as usual augmented by psychiatric consultation intervention: The patients are offered a psychiatric consultation after the assessment interview. It is the aim to optimise treatment in the present health care system."
12012795|NCT00497172|Device|CYPHER Sirolimus-eluting stent|drug-eluting stent
12012796|NCT00497172|Device|Bx SONIC bare metal stent|bare-metal stent
12012797|NCT00497159|Other|Placebo|Placebo TID x 90 days
12012798|NCT00497159|Drug|Dimebon|Dimebon 20 mg TID x 90 days
12012799|NCT00497146|Drug|paricalcitol|2 µg capsule
12012800|NCT00497146|Drug|placebo|placebo capsule
12012801|NCT00497120|Drug|acetazolamide|
12012802|NCT00497120|Drug|placebo|
12012803|NCT00497120|Procedure|uvulopalatopharygoplasty|
12012804|NCT00497107|Drug|UFT, Calcium Folinate, PSK|
12012805|NCT00497107|Drug|UFT, Calcium Folinate|
12012806|NCT00497094|Device|carotid artery stenting|Using retrograde transfemoral access an overview aortic angiogram is established. A stiff wire is then placed in the external carotid or distal common carotid artery to introduce a long hydrophilic sheath into the common carotid artery. The stenosis is then crossed with a Filter wire. For stent implantation Monorail Carotid Wallstents or the Monorail Nitinol Stent of Boston Scientific are used. Road map or overlay technique with a magnification of 20 to 28 inch is used to localize the stenosis during the procedure. Finally a control angiogram is performed to ensure correct placement of the stent. After successful completion of the procedure, the arterial access site is closed using a standard closure device.
12012807|NCT00497081|Drug|mirtazapine|mirtazapine 30 mg daily for 3 months
12012808|NCT00497081|Drug|placebo|placebo 30 mg daily for 3 months
12012809|NCT00497068|Behavioral|tobacco abstinent contingent|Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence
12012810|NCT00497068|Behavioral|non-contingent|Participants receive vouchers regardless of tobacco use status
12012811|NCT00497068|Behavioral|control|this group receives no vouchers
12012812|NCT00497055|Drug|Aripiprazole|
12012813|NCT00497055|Drug|Placebo|Sugar pill manufactured to mimic Aripiprazole gel caps.
12012814|NCT00497042|Device|Self Adjusting File|
12012815|NCT00497029|Drug|fluoride varnish|
12012816|NCT00497029|Behavioral|patient education|
12012817|NCT00497016|Drug|atorvastatin 80 mg|
12012818|NCT00497003|Drug|Treatment with either metoprolol or carvedilol|
12012819|NCT00496990|Behavioral|Enhanced care|this group received counseling, contingency management and methadone or detoxification
12012820|NCT00496990|Behavioral|control|this group receives the opportunity to participate in a support group
12012821|NCT00496977|Procedure|annual CT screening|
12012822|NCT00496964|Drug|Botulinum toxin A + exercise|Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain
12012823|NCT00496964|Drug|Placebo|Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome
12012824|NCT00496951|Device|Vagal tone assessment|An EKG will be obtained using a Physio-control EKG monitor (R wave Electronics of Florida) in standard application, with three chest leads. The EKG data is inputted into a vagal tone monitor (Delta Biometrix, Bethesda MD) which computes vagal tone from the EKG signal. This data is then transferred to a disk which is analyzed off-line.
12012825|NCT00496938|Device|XIENCE V®/ XIENCE PRIME™|Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
12012826|NCT00496873|Drug|Cytoxan|600 mg/m^2 on Day 1 of 21-day cycle.
12012827|NCT00496873|Drug|Nipent|4 mg/m^2 on Day 1 of 21 Day Cycle.
12012828|NCT00496873|Drug|Rituxan|375 mg/m^2 on Day 1 of 21 Day Cycle.
12012829|NCT00496860|Biological|ALT-801|Dose escalation (0.015 mg/kg, 0.04 mg/kg, 0.08 mg/kg, 0.12 mg/kg, 0.14 mg/kg, 0.16 mg/kg), intravenous infusions, two treatment cycle, each cycle with 4 daily on-dose infusion, 10 days rest between cycles.
12012830|NCT00496847|Drug|PERIOGEN|Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
12012831|NCT00496847|Drug|Beta TCP alone|Implantation of β-TCP (0.5 g) alone
12012832|NCT00496834|Drug|losartan potassium|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
12012833|NCT00496834|Drug|Comparator: carvedilol|Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
12012834|NCT00496834|Drug|Comparator: losartan (+) hydrochlorothiazide (HCTZ)|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
12012871|NCT00496574|Biological|Novo Helisen Depot, Phostal|subcutaneous immunotherapy
12012835|NCT00496834|Drug|Comparator: carvedilol (+) hydrochlorothiazide|Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
12012836|NCT00496821|Drug|ALN-RSV01|
12012837|NCT00496808|Drug|Herceptin (Trastuzumab)|8 mg/kg IV Over 90 Minutes
12012838|NCT00496795|Other|epirubicin/docetaxel sequential|Epirubicin 60 mg/m2, q2w 4 cycles. Followed by docetaxel 100 mg/m2 q2w 4 cycles
12012839|NCT00496782|Drug|maraviroc|Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
12012840|NCT00496782|Procedure|Trofile Assay and HIV RNA quantification assay|Trofile Assay and HIV RNA quantification assay
12012841|NCT00496769|Drug|Apixaban|Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks
12012842|NCT00496769|Drug|Acetylsalicylic acid|Tablets, oral, 81-324 mg, once daily, up to 156 weeks
12012843|NCT00496756|Drug|Sorafenib|initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg
12012844|NCT00496743|Device|Low-dose total skin electron beam therapy (4 Gy)|
12012845|NCT00496730|Drug|simvastatin (+) ezetimibe|simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
12012846|NCT00496730|Drug|Comparator: atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
12012847|NCT00496717|Device|Helicoidal fast scann|Each patient will have an computed aortic tomodensitometric scan without contrast injection. This procedure lasts few minutes and irradiation is low. The aortic calcium scoring is calculated using a specific program included in the scan machine
12012848|NCT00496704|Drug|capecitabine|
12012849|NCT00496704|Drug|gemcitabine hydrochloride|
12012850|NCT00496704|Drug|oxaliplatin|
12012851|NCT00496691|Behavioral|Family-based HIV prevention program|comparison between parent-child intervention targeting parent-teen sexual communication, condom use skills, and assertiveness training to an adolescent-only intervention that targets similar constructs minus parent-teen sexual communication and a general health promotion intervention
12012852|NCT00496678|Behavioral|Navigation|Cancer patients are randomly assigned to receive standard of care or the help of a trained person to navigated them through the cancer care system
12012853|NCT00496678|Behavioral|Standard of Care|Cancer patients receive standard of care for their cancer treatment
12012854|NCT00496665|Drug|Vandetanib|Taken orally once a day in 28-day cycles (the dose will vary)
12012855|NCT00496665|Drug|Cyclophosphamide|Metronic Chemotherapy: Low dose pills taken every day of each 28-day cycle
12012856|NCT00496665|Drug|Methotrexate|Metronic Chemotherapy: low dose pills taken on days 1 and 2 of each week
12012857|NCT00496652|Radiation|Radiotherapy|Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)
12012858|NCT00496652|Drug|Zalutumumab|Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)
12012859|NCT00496639|Procedure|angioplasty|Balloonplasty of the stenotic lesion at the venous anastomosis of the thrombosed AV graft.
12012860|NCT00496639|Procedure|stent placement|Balloonplasty plus stent deployment at the stenotic lesion at the venous anastomosis of the thrombosed AV graft
12012861|NCT00496626|Biological|Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)|Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
12012862|NCT00496626|Biological|Comparator: Placebo|aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
12012863|NCT00496613|Behavioral|Mini-Mental State Exam and Blood draw|The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
12012864|NCT00496613|Behavioral|Mini-Mental State Exam and Blood Draw|The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
12012865|NCT00496613|Behavioral|Mini-Mental State Exam and Blood Draw|The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
12012866|NCT00496600|Drug|Patupilone|RAD001 will be taken orally starting at a dose of 30 mg every week for the first cohort of patients, one hour prior to administration of patupilone. Patupilone will then be administered as an infusion, starting at 5 mg/m2 for the first cohort of patients. The dosage and scheduling of RAD001 and patupilone during each 21-day cycle will vary according to cohort assignment
12012867|NCT00496600|Drug|RAD001|RAD001 will be taken orally starting at a dose of 30 mg every week for the first cohort of patients, one hour prior to administration of patupilone. Patupilone will then be administered as an infusion, starting at 5 mg/m2 for the first cohort of patients. The dosage and scheduling of RAD001 and patupilone during each 21-day cycle will vary according to cohort assignment
12012868|NCT00496587|Drug|Capecitabine|800 mg/m^2 By Mouth Twice Daily On Days 1-21.
12012869|NCT00496587|Drug|Gemcitabine|900 mg/m^2 By Vein Over 30 Minutes on Days 1 and 15.
12012872|NCT00496561|Biological|subcutaneous immunotherapy (House Dust Mites)|subcutaneous immunotherapy (House Dust Mites)
12012873|NCT00496561|Other|placebo of subcutaneous immunotherapy (House Dust Mites)|placebo of subcutaneous immunotherapy (House Dust Mites)
12012874|NCT00496548|Procedure|Fecal calprotectin|Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
12012875|NCT00496548|Procedure|Urinary PGE-M Level|Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
12012876|NCT00496535|Drug|TNFerade biologic|
12012877|NCT00496522|Procedure|Proton Beam Therapy|A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
12012878|NCT00496509|Drug|ZD6474 (Zactima) 100mg|
12012879|NCT00496509|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MR)|
12012880|NCT00496509|Procedure|Biomarker Draws|
12012881|NCT00496509|Drug|ZD6474 (Zactima) 300mg|
12012882|NCT00496483|Drug|LCP Tacro (tacrolimus)|"Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
~Other Names:
~Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets."
12012883|NCT00496483|Drug|Prograf|"Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
~Other Names:
~Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets."
12012884|NCT00496470|Drug|Symbicort (budesonide/formoterol turbuhaler 320/9ug)|Symbicort (budesonide/formoterol turbuhaler 320/9ug)
12012885|NCT00496470|Drug|Spiriva (tiotropium bromide 18ug)|Spiriva (tiotropium bromide 18ug)
12012886|NCT00496457|Drug|Experimental|Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks
12012887|NCT00496457|Drug|Placebo comparator|4 Capsules of PBO per day before noon meal
12012888|NCT00496444|Drug|Azacitidine|Starting Dose 20 mg/m^2 administered subcutaneously (under the skin), daily, for ten days (Days 1 -10) of every 4 Week Cycle.
12012889|NCT00496444|Drug|Valproic Acid|Starting Dose 10 mg/Kg once daily by mouth, every day of 4 Week Cycle.
12012890|NCT00496431|Drug|histone deacetylase inhibitor (ITF2357)|50 mg b.i.d. (or every 8 hours or every 6 hours), every day
12012891|NCT00496418|Device|Mesh in permanent colostomy|
12012892|NCT00496405|Drug|bevacizumab|
12012893|NCT00496392|Drug|Nasal fentanyl|Breakthrough pain in patients with breast or prostate cancer
12012894|NCT00496379|Drug|ZK219477|Given intravenously over approximately 30 minutes once every 3 weeks
12012895|NCT00496366|Drug|Capecitabine|The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
12012896|NCT00496366|Drug|Lapatinib|The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
12012897|NCT00496353|Drug|MK2461|MK2461 treatment, bid, 28-day
12012898|NCT00496340|Drug|Pentostatin|"Pre-conditioning therapy:
~All participants will receive pentostatin 4 mg/m^2 on day -28. Patients may receive additional doses on days -21 & -14 depending on cell counts.
~Participant will receive pentostatin at a dose of 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3."
12012899|NCT00496340|Drug|Busulfan|"Pre-conditioning therapy:
~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4.
~Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600."
12012900|NCT00496340|Drug|Rituximab|"Pre-conditioning therapy:
~Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines."
12012901|NCT00496340|Procedure|Allogeneic Hematopoietic Cell Transplant|Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.
12012902|NCT00496327|Biological|Varicella Virus Vaccine Live (Oka-Merck)|VARIVAX(TM) (Refrigerated) [Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose.
12012903|NCT00496314|Device|e2TM Cervical Cell Collector|
12012904|NCT00496301|Drug|Gemcitabine, Capecitabine and Sorafenib (6 cycles)|Gemcitabine: 1000 mg/m2 i.v. days 1 and 8. Capecitabine: 650 mg/m2 i.v. day 1 to 14. (change to 500mg/m2 after amendment nº2 (dated on 10/10/2007) Sorafenib:400 mg/12h v.o. day 1 to 21
12012905|NCT00496288|Radiation|Prophylactic radiation to the contralateral breast|The contralateral breast will be treated with 2 tangent fields, using 1.8-2 Gy/fx to a total dose of 50-50.4 Gy. The whole breast will be treated according to traditional guidelines and as described in the RTOG/NSABP B39 study. The heart should be maximally blocked for left sided breasts, included lung tissue should be reduced to minimum. No overlapping field is allowed on the skin between the two breast fields in the midline. Maximal dose should not exceed 110%
12012906|NCT00496275|Drug|Zactima (ZD6474)|
12012907|NCT00496275|Drug|Vinorelbine plus cisplatin|
12012908|NCT00496275|Drug|Gemcitabine plus cisplatin|
12012909|NCT00496262|Biological|Human Fibrinogen Concentrate|Single intravenous infusion of 70 mg/kg body weight
12012910|NCT00496236|Drug|TNFerade biologic|
12012911|NCT00496223|Drug|Sunitinib|Sunitinib will be given PO once daily on days 1-14 of each 21 day cycle. The exact dose of sunitinib will be determined during the Phase I part of the trial.
12012912|NCT00496223|Drug|Dacarbazine|Dacarbazine will be given at 1000 mg/m2 on day 1 of every 21 day cycle.
12012967|NCT00495807|Behavioral|Totally Negative Words|Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h
12013065|NCT00495053|Other|Placebo|Matching placebo (PBS-20% sucrose)
12012913|NCT00496197|Drug|Eraxis (anidulafungin)|Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
12012914|NCT00496197|Drug|Diflucan (fluconazole)|Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.
12012915|NCT00496197|Drug|Vfend (voriconazole)|Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
12012916|NCT00496184|Drug|Nifedipine cream topical application|
12012917|NCT00496158|Drug|Clevudine|
12012918|NCT00496158|Drug|Adefovir|
12012919|NCT00496145|Behavioral|Spanish Diabetes Self-Management Program|small-group self management education program
12012920|NCT00496132|Drug|PRO131921|Escalating doses by IV infusion
12012921|NCT00496119|Radiation|Proton Beam Therapy|70 Gy once daily at 2 CGE per fraction, no sooner than 2 weeks after last surgery to remove tumor, for between 35-39 treatments.
12012922|NCT00496119|Radiation|Photon Beam Therapy|Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.
12012923|NCT00496106|Behavioral|Telephone counseling|6 telephone counseling sessions
12012924|NCT00496106|Behavioral|Telephone interview|telephone interview
12012925|NCT00496093|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
12012926|NCT00496080|Device|Doppler-Guided Uterine Artery Occlusion Device (DUAO)|Investigational transvaginal clamp inserted one time for 6 hours.
12012927|NCT00496067|Device|Doppler-Guided Uterine Artery Occlusion Device|For bilateral occlusion of the uterine arteries
12012928|NCT00496054|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.
12012929|NCT00496041|Procedure|Registry|A Registry will be used.
12012930|NCT00496028|Drug|AZD0530|oral tablet
12012931|NCT00496028|Drug|Carboplatin|intravenous infusion
12012932|NCT00496028|Drug|Paclitaxel|intravenous infusion
12012933|NCT00496015|Biological|Pneumococcal conjugate vaccine GSK1024850A.|1 intramuscular injection.
12012934|NCT00496015|Biological|Infanrix hexa.|1 intramuscular injection.
12012935|NCT00496015|Biological|Meningococcal vaccine GSK134612.|1 intramuscular injection.
12012936|NCT00496015|Drug|Paracetamol.|Body weight of < 7 kg: none; Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.
12012937|NCT00496002|Drug|Clevudine|
12012938|NCT00496002|Drug|Adefovir|
12012939|NCT00495989|Procedure|saliva sampling + dental calculus collection|
12012940|NCT00495976|Other|A commercially produced cordial drink|
12012941|NCT00495963|Procedure|bronchoaleolar lavage|
12012942|NCT00495963|Procedure|Bronchoscopy|
12012943|NCT00495950|Behavioral|Questionnaire|Questionnaires relating to symptoms experienced during and following standard cancer treatment.
12012944|NCT00495924|Procedure|Pancreatic resection (PD)|PD is a standard therapeutic surgical procedure. No additional interventions are performed.
12012945|NCT00495898|Device|CYPHER sirolimus-eluting stent|drug-eluting stent
12012946|NCT00495898|Device|uncoated Bx VELOCITY balloon-expandable stent|bare metal stent
12012947|NCT00495885|Drug|volinanserin (M100907)|oral, one tablet taken around bedtime
12012948|NCT00495885|Drug|Placebo|oral, one tablet taken around bedtime
12012949|NCT00495872|Drug|Dasatinib|50 mg by mouth (PO) Twice Daily for 28 Days Every 28 Days
12012950|NCT00495872|Drug|Erlotinib|100 mg PO Daily for 28 Days Every 28 Days
12012951|NCT00495872|Drug|Lapatinib|1000 mg PO Daily for 28 Days Every 28 Days
12012952|NCT00495872|Drug|Lenalidomide|15 mg PO Daily for 28 Days Every 28 Days
12012953|NCT00495872|Drug|Sorafenib|400 mg PO Daily for 21 Days Every 28 Days
12012954|NCT00495872|Drug|Sunitinib|25 mg PO Daily for 21 Days Every 28 Days
12012955|NCT00495872|Drug|Valproic Acid|40 mg/kg PO Daily for 7 Days, then 7 Days Off
12012956|NCT00495859|Dietary Supplement|Immunonutrition|food for special medical purpose (FSMP)
12012957|NCT00495859|Dietary Supplement|food for special medical purposes (FSMP)|an isocaloric isonitrogenous non-specific nutritional support
12012958|NCT00495846|Drug|Octreotide-LAR, Lanreotide Autogel|Octreotide-LAR intramuscular, dose of 30 mg every 28 days to increase up to 60 mg; lanreotide autogel 120 mg deep subcutaneous every 28 days for 3 months then uptitrated according with the protocol.
12012959|NCT00495846|Other|Locoregional treatments|
12012960|NCT00495833|Behavioral|Personalized brochure|either photo personalization, blood pressure personalization, both, or no personalization
12012961|NCT00495833|Behavioral|Promotional gift|half of participants who go to a fire station will receive a gift card.
12012962|NCT00495820|Drug|Methylphenidate|Subject will receive 5mg twice a day for two weeks then 10mg twice a day until week 12 of the study.
12012963|NCT00495820|Other|Placebo|Standard inactive pill.
12012964|NCT00495807|Behavioral|No Words|Without any words was given during pain management
12012965|NCT00495807|Behavioral|Positive words|Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.
12012966|NCT00495807|Behavioral|Partially Negative Words|Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.
12012968|NCT00495794|Behavioral|Clinical pharmacist-based intervention|Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms
12012969|NCT00495781|Procedure|%-hypo (laboratory parameter, functional iron deficiency)|
12012970|NCT00495781|Procedure|CHr (laboratory parameter, functional iron deficiency)|
12012971|NCT00495781|Procedure|RET-HE (laboratory parameter, functional iron deficiency)|
12012972|NCT00495768|Behavioral|Group Training|Participants will be trained in techniques that are useful to cope with possible side effects of treatment, such as: keeping a journal (expressive writing), breathing exercises, cognitive behavioral therapy, mindfulness meditation, and exercise.
12012973|NCT00495755|Drug|Alemtuzumab (Campath)|An escalating dose given over 4 weeks
12012974|NCT00495729|Drug|SB-649868|Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.
12012975|NCT00495729|Drug|Placebo|Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.
12012976|NCT00495729|Drug|Simvastatin|Subjects will receive Simvastatin 10 mg tablets orally.
12012977|NCT00495716|Drug|acyclovir|800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
12012978|NCT00495716|Drug|acyclovir|400 mg acyclovir orally twice daily for 1 year
12012979|NCT00495703|Behavioral|Exercise|6-months of regular aerobic exercise
12012980|NCT00495703|Behavioral|Usual Care|6-months of behavioral strategies to aid memory/cognition
12012981|NCT00495690|Drug|Oral zinc gluconate (5 mg elemental)|Each infant in the study received placebo or 5 mg of elemental zinc (1 RDA) as zinc acetate syrup once daily from 4 weeks of age till 6 months of age.
12012982|NCT00495677|Drug|PF-00232798|Solution, 20 mg. once daily, 10 days
12012983|NCT00495677|Drug|PF-00232798|Solution, 150 mg. once daily, 10 days
12012984|NCT00495677|Drug|PF-00232798|Solution, 5 mg. once daily, 10 days
12012985|NCT00495677|Drug|PF-00232798|Solution, 40 mg. once daily, 10 days
12012986|NCT00495677|Drug|PF-00232798|Solution, 300 mg. once daily, 10 days
12012987|NCT00495677|Drug|PF-00232798|Solution, 400 mg. once daily, 10 days
12012988|NCT00495664|Device|Titan stent and Taxus-Liberte stent|
12012989|NCT00495651|Drug|Antiretroviral medications|Antiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is observed.
12012990|NCT00495651|Drug|Antiretroviral medications+Isoniazid prophylaxis|"Antiretroviral initiation at any time during the trial if at least one 2009 WHO-recommended criterion for starting ART is observed.
~Isoniazid prophylaxis:300 mg of INH once a day before breakfast for six months, starting one month after study inclusion"
12012991|NCT00495651|Drug|Antiretroviral medications|Early ART initiation on the day of inclusion, before reaching the current WHO criteria
12012992|NCT00495651|Drug|Antiretroviral medications+Isoniazid prophylaxis|"Early Antiretroviral medications initiation on the day of inclusion, before reaching the current WHO criteria
~Isoniazid prophylaxis: 300 mg of INH once a day before breakfast for six months, starting one month after study inclusion"
12012993|NCT00495625|Drug|Sunitinib Malate|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
12012994|NCT00495612|Drug|Omalizumab|Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
12012995|NCT00495612|Drug|Placebo|Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
12012996|NCT00495599|Procedure|Cytokines assessed from fat tissue|Cytokines assessed from fat tissue
12012997|NCT00495586|Drug|Placebo|One pill to be taken every eight hours for 8 days
12012998|NCT00495586|Drug|Amoxicillin and clavulanic acid|500-125 mg to be taken every eight hours for 8 days
12012999|NCT00495573|Drug|acyclovir|400 mg acyclovir, orally three times a day for 5 days
12013000|NCT00495560|Drug|Addition of misoprostol 25 mcg 12 hours before induction|Misoprostol given buccally the night before induction
12013001|NCT00495547|Drug|Azacitidine|Azacitidine
12013002|NCT00495547|Drug|Beta Erythropoietin|Beta Erythropoietin
12013003|NCT00495521|Drug|4-Aminosalicylic acid extended release granules|Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm
12013004|NCT00495508|Drug|Quinine|
12013005|NCT00495508|Drug|artemether / lumefantrine|
12013006|NCT00495495|Device|Ozone treatment|Ozone treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three, Six and Nine-Month visits.
12013007|NCT00495495|Device|Placebo treatment|Placebo treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three-, Six- and Nine-Month visits.
12013008|NCT00495469|Drug|GSK189075|GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet
12013009|NCT00495469|Drug|Placebo|Available as Placebo matching tablet to GSK189075
12013010|NCT00495443|Device|Peterio|
12013011|NCT00495417|Biological|AFFITOPE AD01|s.c. injection
12013012|NCT00495417|Biological|AFFITOPE AD01 adjuvanted|s.c. injection
12013013|NCT00495404|Behavioral|Physician Treatment Guidelines|
12013014|NCT00495391|Drug|Nitazoxanide|One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
12013015|NCT00495391|Drug|Placebo|One oral placebo tablet twice daily for 52 weeks.
12013016|NCT00495391|Biological|Peginterferon alfa-2a|Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
12013017|NCT00495391|Drug|Ribavirin|1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
12013018|NCT00495378|Drug|epoetin alfa|
12013019|NCT00495365|Drug|Epoetin alfa|
12013020|NCT00495352|Drug|Hihg-doseNRT, Low-dose NRT, bupropion|
12013021|NCT00495339|Drug|Levofloxacin|500-1000 mg once a day daily per os with combination of drugs.
12013022|NCT00495326|Drug|Nevirapine based therapy|"Patients below 60 kg: 1 tablet twice a day of Triomune30®, including NVP 200 mg, 3TC 150 mg and D4T 30mg
~Patients above 60kg: 1 tablet twice a day of Triomune40®, including NVP 200 mg, 3TC 150 mg and D4T 40 mg)"
12013023|NCT00495326|Drug|Efavirenz based therapy|Efavirenz EFV 200 mg (3 tablets/d) Lamivudine 3TC 300mg (2 tablets of 150mg/d) D4T generic 30mg or 40mg (2 tablets/d)
12013024|NCT00495326|Drug|Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)|"Intensive phase: 2 months daily E(RMP)HZ. PTB smear positive patients at month 2 will receive 1 more month intensive phase.
~Continuation phase: 4 months daily H(RMP).
~Patients with meningitis will receive Streptomycin instead of E during intensive phase."
12013025|NCT00495313|Drug|doxycycline|COL-101, QD plus metronidazole
12013026|NCT00495313|Drug|doxycycline|40 mg with metronidazole QD
12013027|NCT00495287|Drug|cytosine arabinoside|"Arm A: use of standard-dose cytosine arabinoside (100 mg/m2/bd iv. on days 1-7) in association with idarubicin and etoposide.
~Arm B: use of high-dose cytosine arabinoside (1000-2000 mg/m2/bd according to age +/-65 years iv. on days 1-2 and 8-9) in association with idarubicin."
12013028|NCT00495274|Drug|Formulation A|Formulation A represents the original formulation. SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing micronized drug substance. Formulation A will be administered in Part A.
12013029|NCT00495274|Drug|Formulation B|Formulation B will represent SB-649868 10 mg film coated tablet containing micronized drug substance (3 tablets to reach 30 mg), but contains additional surfactant. Formulation B will be administered in Part A.
12013030|NCT00495274|Drug|Formulation C|Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A.
12013031|NCT00495274|Drug|Formulation D|Formulation D will represent SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing nanomilled and spray dried powder. Formulation D will be administered in Part A.
12013032|NCT00495274|Drug|Formulation E|Formulation E will represent SB-649868 10 mg capsule (3 capsules to reach 30 mg), containing nanomilled and spray dried powder. Formulation E will be administered in Part A.
12013033|NCT00495274|Drug|Formulation F|Formulation F will represent SB-649868 15 mg liquid filled capsule (2 capsules to reach 30 mg). Formulation F will be administered in Part A.
12013034|NCT00495274|Drug|Formulation G|Formulation G will be the selected formulation of SB-649868 30 mg to be assessed in Part B. The formulation will be administered after a standard FDA High-Fat breakfast
12013035|NCT00495261|Behavioral|Mindfulness-enhanced cognitive behavioural therapy (MCBT)|a variation of cognitive behavioural therapy (CBT)
12013036|NCT00495261|Behavioral|relaxation-enhanced cognitive behavioural therapy (RCBT)|a variation of cognitive behavioural therapy (CBT)
12013037|NCT00495248|Behavioral|Group intervention inspired by Lifestyle Redesign|Group intervention inspired by Lifestyle Redesign
12013038|NCT00495248|Behavioral|Group intervention inspired by Lifestyle redesign|Lifestyle programme once a week for two hours over an intervention period of 9 months
12013039|NCT00495235|Behavioral|Questionnaire|Questionnaire taking about 20 minutes to complete.
12013040|NCT00495222|Procedure|Tissue plication|Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System
12013041|NCT00495222|Device|Endoscopic Suturing System|Tissue plication of dilated GJ stoma
12013042|NCT00495222|Device|Tissue Plication|Tissue plication for GJ stoma reduction
12013043|NCT00495209|Other|Qigong|EQT daily for 5 consecutive days prior to surgery.
12013044|NCT00495196|Procedure|Experimental lung function test|Administration of several CO2 gas mixtures
12013045|NCT00495183|Drug|caffeine|caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
12013046|NCT00495183|Drug|Biperiden|Biperiden 2-4 mg/d, divided in 2 doses per day.
12013047|NCT00495183|Drug|Placebo|Placebo
12013048|NCT00495170|Drug|Carboplatin|2 area under curve (AUC) by vein Weekly
12013049|NCT00495170|Radiation|Proton Radiotherapy|2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks).
12013050|NCT00495170|Drug|Paclitaxel|50 mg/m^2 by vein Weekly
12013051|NCT00495157|Behavioral|Symptom-based adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
12013052|NCT00495157|Behavioral|Biomarker-based adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
12013053|NCT00495157|Behavioral|Guideline-based adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
12013054|NCT00495144|Drug|TH-302|
12013055|NCT00495131|Drug|Pegylated interferon alfa-2a plus ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
12013056|NCT00495131|Drug|Pegylated interferon alfa-2a plus ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
12013057|NCT00495118|Drug|risperidone|
12013058|NCT00495105|Behavioral|Two Servings of Dairy Snacks|2 servings of dairy products as snacks at school to third, fourth, and fifth grade students each day for 24 weeks. The serving size of each dairy snack is based on its calcium content with the goal of adding an extra 300 mg of calcium to the intervention group's daily intake.
12013059|NCT00495092|Drug|Caffeine|Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
12013060|NCT00495092|Drug|Biperiden|Biperiden 2-4 mg/d p.o.
12013061|NCT00495092|Drug|Placebo|Placebo + Placebo
12013062|NCT00495079|Drug|Marqibo® (vincristine sulfate liposomes injection)|Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course.
12013063|NCT00495066|Drug|Ipilimumab|Intravenous Solution, Intravenous, Ipilimumab 3 mg/kg, Ipilimumab - one dose every 3 wks for a total of 4 doses. Subjects who are eligible may receive another 4 doses given every 3 wks; Until disease progression, unacceptable toxicity or withdrawal of consent
12013064|NCT00495053|Drug|hMaxi-K|Two dose levels (5000 µg/90 mL intravesical instillation and 10000 µg/90 mL intravesical instillation)
12013066|NCT00495040|Radiation|Proton Radiotherapy|87.5 CGE with 2.5 Gy/fraction for 35 treatments
12013067|NCT00495027|Behavioral|Internet-delivered Stress Innoculation Training|
12013068|NCT00495014|Drug|GSK376501|
12013069|NCT00495014|Drug|Placebo|
12013070|NCT00494988|Drug|insulin aspart|
12013071|NCT00494988|Drug|insulin NPH|
12013072|NCT00494975|Device|Narrow band UVB phototherapy , long wave UVA phototherapy|A UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. ) and 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
12013073|NCT00494962|Drug|lecozotan SR|
12013074|NCT00494949|Drug|Hemospan (MP4OX)|200, 400, 600, 750, or 1000 mL of Hemospan (MP4OX)
12013075|NCT00494949|Drug|Ringer's lactate|200, 400, 600, 750, or 1000 mL of Ringer's lactate solution
12013076|NCT00494910|Behavioral|Meaning Centered Group Psychotherapy|this eight-week (1 ½ hour weekly sessions) Session 1 - Concepts of Meaning and Sources of Meaning Session 2 - Cancer and Meaning Session 3 - Meaning and Historical Context of Life Session 4 - Storytelling, Legacy Project (optional) Session 5 - Limitations and Finiteness of Life Session 6 - Responsibility, Creativity, Deeds Session 7 - Experience, Nature, Art, Humor Session 8 - Transitions, Goodbyes, Hopes for the Future
12013077|NCT00494910|Behavioral|Supportive Group Psychotherapy|The eight weekly 1 ½ hour sessions will focus on group discussion on a set of specific themes that emerge for patients coping with cancer. The session themes or topics will include such issues as: the discussion of strategies for coping with medical issues and procedures, communication with health care providers and issues related to family, friends, and occupational life.
12013078|NCT00494897|Drug|Asparaginase|
12013079|NCT00494897|Drug|Cyclophosphamide|
12013080|NCT00494897|Drug|Cytarabine|
12013081|NCT00494897|Drug|Daunorubicin|
12013082|NCT00494897|Drug|Mercaptopurine|
12013083|NCT00494897|Drug|Prednisone|
12013084|NCT00494897|Drug|Vincristine|
12013085|NCT00494897|Drug|Methotrexate|
12013086|NCT00494897|Procedure|Intrathecally treatment|
12013087|NCT00494884|Drug|vildagliptin|
12013088|NCT00494871|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Participants orally administered rivaroxaban 15 mg OD (CrCL [creatinine clearance] >= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)
12013089|NCT00494871|Drug|Warfarin|Participants orally administered a warfarin potassium tablet (INR [international normalized ratio] target was 1.6-2.6 for patients >70 years and 2.0-3.0 for patients <70 years)
12013090|NCT00494871|Drug|Rivaroxaban placebo|Participants orally administered a rivaroxaban placebo tablet
12013091|NCT00494871|Drug|Warfarin placebo|Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)
12013092|NCT00494858|Behavioral|Cognitive behavioral therapy - focused (CBT-EF)|Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.
12013093|NCT00494858|Behavioral|Cognitive behavioral therapy - broad (EB)|Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.
12013094|NCT00494845|Behavioral|Mindfulness|8-week mindfulness program will be compared to an education control group.
12013095|NCT00494845|Behavioral|Control: Health Education Class|8-week education program
12013096|NCT00494832|Drug|Dexmedetomidine|"10 minutes loading dose of 0.9 mcg/kg
~Maintenance dose of 0.6 mcg/kg/hour"
12013097|NCT00494832|Drug|Normal Saline|"10 minutes loading dose of 0.9 mcg/kg
~Maintenance dose of 0.6 mcg/kg/hour"
12013098|NCT00494806|Other|Rocking Chair Intervention|Patient out of bed rocking in a rocking chair at a constant rate of one rock cycle per second (back and forth), in ten to twenty minute increments, for at least sixty minutes per day or 3600 rock cycles and ambulate at least twice per day beginning the first postoperative day.
12013099|NCT00494793|Procedure|VAWC and mesh mediated fascial traction|"The first period of 2-5 days only the abdominal VAWC dressing is applied. On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
~The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
~Finally the mesh is removed and the fascia is closed"
12013100|NCT00494780|Drug|Ofatumumab|ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given
12013101|NCT00494780|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
12013102|NCT00494780|Drug|Doxorubicin|Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
12013103|NCT00494780|Drug|Vincristine|Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
12013104|NCT00494780|Drug|Prednisolone, Prednisone or equivalent|100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
12013105|NCT00494767|Drug|GW869682|GW869682 tablet with a dose strength of 250 mg will be available for subjects
12013106|NCT00494767|Drug|GSK189075|GSK189075 tablet with a dose strength of 250 mg will be available for subjects
12013107|NCT00494767|Drug|GSK189075-Placebo|Placebo tablets to match GSK189075 250 mg will be available for subjects
12013108|NCT00494767|Drug|GW869682-Placebo|Placebo tablets to match GW869682 250 mg will be available for subjects
12013109|NCT00494741|Drug|mycophenolate mofetil|Patients randomized in this group will receive 750 mg of MMF per os twice a day starting on the day of transplant. MMF dose will be reduced in case of white blood cell count lower than 2,000/mm3 and whenever deemed clinically appropriate.
12013110|NCT00494741|Drug|azathioprine|Patients randomized in this group will receive 75 mg of AZA per os (or 125 mg if body weight > 75 kg) once a day starting on the day of transplant. AZA dose will be reduced in case of white blood cell count lower than 2,000/mm3 and whenever deemed clinically appropriate.
12013111|NCT00494728|Behavioral|Smoking Cessation Treatment|12 60-minute individual sessions of standard smoking cessation treatment.
12013112|NCT00494728|Drug|Nicotine Replacement Therapy|21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks.
12013286|NCT00493337|Behavioral|advanced adherence counseling+reminder|
12013113|NCT00494728|Behavioral|CBASP|Individual counseling sessions where taught/develop interpersonal and behavioral coping skills to help decrease depression and negative moods, and to increase ability to quit smoking.
12013114|NCT00494715|Drug|Benazepril|Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
12013115|NCT00494715|Drug|Valsartan|Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
12013116|NCT00494715|Drug|Benazepril/Valsartan|Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
12013117|NCT00494702|Procedure|Resuscitation|Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%
12013118|NCT00494702|Procedure|Resuscitation|Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%
12013119|NCT00494676|Device|High power (57 prism diopter) peripheral prism glasses|All patients will wear two pairs of prism glasses in a crossover design: the high power peripheral prism glasses and sham peripheral prism glasses. Each pair of prism glasses will be worn for four weeks
12013120|NCT00494676|Device|Low power sham peripheral prism glasses|Low power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion.
12013121|NCT00494663|Drug|DIO-902|150mg tablet once per day for 16 weeks
12013122|NCT00494663|Drug|DIO-902|300mg tablet once per day for 16 weeks
12013123|NCT00494663|Drug|DIO-902|450mg DIO-902 tablet once daily for 16 weeks
12013124|NCT00494663|Drug|DIO-902 placebo|DIO-902 placebo tablet once daily for 16 weeks
12013125|NCT00494663|Drug|DIO-902|150mg tablet of DIO-902 once daily for 16 weeks
12013126|NCT00494663|Drug|DIO-902|300mg DIO-902 tablet daily for 16 weeks
12013127|NCT00494663|Drug|DIO-902|450mg DIO-902 tablet for 16 weeks
12013128|NCT00494663|Drug|DIO-902 placebo|DIO-902 placebo tablet once daily for 16 weeks
12013129|NCT00494650|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include 12 to 16 counseling sessions, occurring weekly or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions.
12013130|NCT00494650|Behavioral|Brief PTSD treatment|Brief PTSD treatment will include three weekly meetings with a therapist. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD.
12013131|NCT00494637|Drug|sodium bicarbonate|isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours
12013132|NCT00494624|Drug|prednisolone|
12013133|NCT00494611|Drug|Peri operative Cetuximab.|Cetuximab will be given immediately preoperative and early post surgery period.
12013134|NCT00494598|Drug|Sufentanil|200 mcg intra-arterial one time bolus
12013135|NCT00494585|Drug|CEP-701|80 mg orally twice a day for 30 days
12013136|NCT00494572|Drug|Montelukast|10 mg rapid dissolving granule in sterile water orally once
12013137|NCT00494572|Other|sterile water|sterile water
12013138|NCT00494559|Drug|Pioglitazone|Actos 15mg once a day before breakfast
12013139|NCT00494559|Drug|Placebo|Placebo drug with the same appearance as actos
12013140|NCT00494546|Procedure|Pd-103 with 20 vs 44 Gy supplemental beam XRT|
12013141|NCT00494533|Drug|Remodulin (treprostinil sodium)|
12013142|NCT00494520|Procedure|Errorful training condition|"Errorful training condition: Participant saw a picture and named it without any cues. If an error was produced, the cue with the least amount of information was provided (e.g. for pumpkin, pu). Cues with increasing information were provided until the picture was correctly named (e.g. for pumpkin: pump, pumpki, then pumpkin). Once the correct name was provided, the trial ended."
12013143|NCT00494520|Procedure|Errorless training condition|"Errorless learning (EL) condition: Participant saw a picture with its name, and repeated the word. The participant continued to name the picture as the auditory cues provided less and less of the word (e.g. for banana she would hear banan, bana then ba and finally no cue). If an error was produced at any stage, the whole word was presented, the participant repeated it, and the trial ended."
12013144|NCT00494507|Drug|Dichlorphenamide (double-blind)|50mg tablet; maximum dosage 400mg/day
12013145|NCT00494507|Drug|Placebo (double-blind)|Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
12013146|NCT00494507|Drug|Dichlorphenamide (open-label)|50mg tablet; maximum dosage 400mg/day
12013147|NCT00494494|Drug|Standard Care|topical antibiotic for 10 days plus topical corticosteroids for 1 month
12013148|NCT00494494|Drug|nepafenac|liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid
12013149|NCT00494481|Drug|Vandetanib (ZD6474)|once daily oral dose
12013150|NCT00494481|Drug|Docetaxel|intravenous infusion
12013151|NCT00494468|Drug|Zolpidem|
12013152|NCT00494455|Device|continuous subcutaneous glucose monitoring|continuous subcutaneous glucose monitoring for 72h
12013153|NCT00494455|Device|continuous subcutaneous glucose monitoring|continuous subcutaneous glucose monitoring for 72h
12013154|NCT00494442|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12013155|NCT00494442|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
12013156|NCT00494429|Drug|Morphine|Gestational Age< 29 weeks: A loading dose of 0.05 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.005 mg/kg/h.
12013157|NCT00494429|Drug|Morphine|Gestational Age>= 29 weeks: A loading dose of 0.1 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.01 mg/kg/h.
12013158|NCT00494416|Other|delivery approaches of malaria intermittent preventive treatment in pregnancy|"Health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.
~Joint with advanced strategies delivery approach (JAS). In addition to passive delivery at health centres, the pregnant women will be reached during preventive activities the health staff carry out regularly in villages Community based distribution delivery approach (CBD). In addition to passive delivery at health centres, the pregnant women will be reached by traditional birth attendants (TBAs) or representatives of village women's associations (RWAs)."
12013159|NCT00494377|Drug|duloxetine|
12013160|NCT00494351|Procedure|Long-pulsed Nd:YAG laser 1064 nm|Laser once monthly
12013161|NCT00494338|Drug|Docetaxel|
12013162|NCT00494312|Drug|Pioglitazone|Pioglitazone 15 mg or 30 mg titrated to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 156 weeks.
12013163|NCT00494312|Drug|Glyburide|Pioglitazone placebo-matching tablets, orally, once daily and glyburide 5 mg or 10 mg titrated to 15 mg, capsules, orally, once daily for up to 156 weeks.
12013164|NCT00494299|Drug|Sorafenib (Nexavar, BAY43-9006)|Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
12013165|NCT00494299|Drug|Placebo|Placebo: matching placebo
12013166|NCT00494286|Behavioral|Abused-focused cognitive behavioral therapy (AF-CBT)|Practitioners will be randomly assigned to provide the AF-CBT treatment for 3 to 6 months. Patient participants will continue to see their regular practitioner, but will receive AF-CBT at treatment visits. Practitioners who are assigned to AF-CBT will first receive training in the treatment method. The training curriculum will include a published treatment book, intensive training sessions, which will occur weekly for 8 hours over 4 weeks, handouts that illustrate key therapeutic information and exercises, and ongoing case consultation reviews for 5 months.
12013167|NCT00494286|Behavioral|Treatment as usual (TAU)|This condition consists of those practitioners in each agency who will not receive study training in AF-CBT. These practitioners will simply provide services as available within their agencies.
12013168|NCT00494273|Behavioral|Cognitive Behavioral and Standard Care with Healthy Living|
12013169|NCT00494260|Behavioral|Social Learning and Cognitive Behavioral Therapy (SLCBT)|The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques
12013170|NCT00494260|Behavioral|Education Support (ES)|The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention.
12013171|NCT00494247|Device|coronary stent (Genous, OrbusNeich) with immobilised anti-CD34 antibody to capture circulating endothelial progenitor cells|coronary stent covered with anti-CD34 antobody, (Genous, R-stent, produced by OrbusNeich). 30 patients will undergo PCI with implantation of Genous stent and 30 patients will receive bare metal stent (BMS)
12013172|NCT00494234|Drug|KU-0059436 (AZD2281) (PARP inhibitor)|oral
12013173|NCT00494234|Drug|KU-0059436 (AZD2281) (PARP inhibitor)|
12013174|NCT00494221|Drug|AZD2171|oral tablet
12013175|NCT00494221|Drug|FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)|intravenous infusion
12013176|NCT00494221|Drug|Placebo Cediranib|oral tablet
12013177|NCT00494208|Drug|Testosterone|Testosterone ester
12013178|NCT00494195|Genetic|rAAV1.tMCK.human-alpha-sarcoglycan- First cohort|"The first cohort of subjects with LGMD2D (alpha-sarcoglycan deficiency) and proven mutations will undergo gene transfer with a minimum of three subjects enrolled into this cohort and will receive a total of 1.5 ml volume of study agent in two to six separate injections into the selected muscle (extensor digitorum brevis) or other muscle if more appropriate upon considering the individual patient. The dose will be 3.25 X 10 to the 11 vg in 1.5 ml.
~In each cohort, only one extremity will receive vector with transgene while the opposite extremity will be injected with placebo."
12013179|NCT00494195|Genetic|Genetic: rAAV1.tMCK.human-alpha-sarcoglycan- Second cohort|The second cohort will receive the same dosis of 3.25 X 10 to the 11 vg in 1.5 ml delivered to muscle according to the same paradigm. In each cohort, only one extremity will receive vector with transgene while the opposite extremity will be injected with placebo.
12013180|NCT00494182|Drug|Carboplatin|Given IV
12013181|NCT00494182|Drug|Paclitaxel|Given IV
12013182|NCT00494182|Drug|Sorafenib|Given PO
12013183|NCT00494156|Drug|heparin|
12013184|NCT00494156|Drug|aspirin and clopidogrel|
12013185|NCT00494143|Device|CESR Prosthetic Foot|a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle
12013186|NCT00494143|Device|typical prosthetic foot|patients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team
12013187|NCT00494143|Device|standardized prosthetic foot|a standard foot that has had weights applied to match the mass of the CESR foot
12013188|NCT00494117|Device|ApneaLink|A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
12013189|NCT00494104|Dietary Supplement|Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day|Infants receive daily 0.5 ml of code labeled supplement
12013190|NCT00494091|Drug|Temsirolimus (CCI-779)|20 mg/m2 IV TEMSR weekly (Japan, n=6)
12013191|NCT00494091|Drug|Temsirolimus (CCI-779)|25 mg IV TEMSR weekly (all other pts)
12013192|NCT00494078|Device|Real-time glucose monitoring system (Guardian, Medtronic)|Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.
12013193|NCT00494078|Drug|intensive insulin therapy|intensive insulin therapy according to an algorithm
12013194|NCT00494065|Other|Home exercise|Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.
12013195|NCT00494065|Other|Chiropractic Spinal Manipulative Therapy + Home exercise|The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.
12013196|NCT00494052|Behavioral|Heart to Heart (Web-Based Decision Aid)|Participants in the intervention group will access Heart to Heart, a Web site designed to educate them about their overall CHD risk, specific risk factors, and strategies and preferences for risk reduction.
12013197|NCT00494052|Behavioral|Physician Education Session|A physician education session will be included in the program.
12013198|NCT00494039|Procedure|Radioactive seed implant to prostate|
12013199|NCT00494026|Drug|pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles
12013200|NCT00494026|Drug|carboplatin|Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles
12013201|NCT00494026|Procedure|radiotherapy|2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)
12013202|NCT00494013|Drug|Insulin Lispro Protamine Suspension|Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
12013203|NCT00494013|Drug|Detemir|Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
12013204|NCT00493987|Drug|Testosterone Enanthate|testosterone ester
12013205|NCT00493987|Drug|Dutasteride|5 alpha-reductase inhibitor
12013206|NCT00493974|Drug|Zileuton|Zyflo tablets, 600 mg, 4 times a day
12013207|NCT00493974|Drug|Placebo|Placebo 4 x daily
12013208|NCT00493961|Drug|gonadotropin releasing hormone (GnRH)|Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump)
12013209|NCT00493948|Device|ApneaLink|A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
12013210|NCT00493922|Procedure|Rapid diagnostic test|Introduction of rapid diagnostic test for malaria
12013211|NCT00493922|Procedure|Microscopy|Microscopy for diagnosis of malaria
12013212|NCT00493922|Procedure|Clinical diagnosis for malaria|The use of Clinical diagnosis for the diagnosis of malaria
12013213|NCT00493909|Procedure|intrathecal opioids and thoracic paravertebral analgesia|
12013214|NCT00493909|Procedure|thoracic epidural analgesia|
12013215|NCT00493896|Drug|Fondaparinux|The dose for Arixtra is 2.5 mg once daily, subcutaneously.
12013216|NCT00493896|Drug|Enoxaparin|The dose for Lovenox is 40 mg once daily, subcutaneously.
12013217|NCT00493883|Device|yttrium Y 90 microspheres (TheraSphere®)|Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver
12013218|NCT00493870|Drug|Docetaxel|Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
12013219|NCT00493870|Drug|Doxorubicin|• Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).
12013220|NCT00493870|Drug|Cyclophosphamide|600 mg/m2 IV over 15-30 minutes on Day 1.
12013221|NCT00493857|Drug|Nimotuzumab Humanized Monoclonal Antibody|Nimotuzumab 400mg every week
12013222|NCT00493857|Drug|Nimotuzumab|Nimotuzumab 400mg every 2 weeks
12013223|NCT00493844|Other|Exercise testing|Exercise testing
12013224|NCT00493844|Other|Clinical evaluation + NTproBNP|Clinical evaluation + NTproBNP levels
12013225|NCT00493831|Drug|nicotine polacrilex, transdermal system or inhaler|
12013226|NCT00493818|Drug|GSK690693|
12013227|NCT00493805|Drug|Combination of pegylated interferon alfa-2b and ribavirin|"Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 12 weeks, then up to 4 weeks until HCV PCR results are available, and then for another 36 weeks(Group A) or 60 weeks (Group B) postrandomization.
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 12 weeks, then up to 4 weeks until HCV PCR results are available, and then for another 36 weeks (Group A) or 60 weeks (Group B) postrandomization"
12013228|NCT00493805|Drug|Combination of pegylated interferon alfa-2b and ribavirin|"Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks"
12013229|NCT00493792|Device|Stryker X3 crosslink|Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 years and 10 years.
12013230|NCT00493779|Procedure|Blood Collection|4 weeks
12013231|NCT00493766|Drug|LBH589|
12013232|NCT00493753|Procedure|Acupuncture|
12013233|NCT00493740|Procedure|chocolate cake|
12013234|NCT00493727|Drug|N-acetylcysteine(Mucomyst)|
12013235|NCT00493714|Behavioral|Questionnaire|Surveys lasting 30 minutes or more.
12013236|NCT00493701|Behavioral|High Fat Diet|Daily eating
12013237|NCT00493701|Behavioral|Low Fat Diet|Life style eating habits
12013238|NCT00493688|Other|Cardiopulmonary Exercise Testing (CPET)|Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
12013239|NCT00493675|Procedure|endoscopic bile duct stenting|
12013240|NCT00493662|Drug|Polyethylene Glycol 400 0.4%|
12013241|NCT00493662|Drug|Propylene Glycol 0.3%|
12013242|NCT00493662|Drug|0.15% sodium Hyaluronate|
12013243|NCT00493662|Drug|sodium chloride|
12013244|NCT00493662|Drug|sodium phosphate monobasic|
12013245|NCT00493649|Drug|Taxotere|On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
12013285|NCT00493350|Procedure|Blood Sample|1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers)
12013246|NCT00493649|Drug|Cytoxan|On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
12013247|NCT00493649|Drug|Herceptin|On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
12013248|NCT00493636|Drug|Gemcitabine|Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
12013249|NCT00493636|Drug|Sorafenib|Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
12013250|NCT00493636|Drug|Placebo|Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
12013251|NCT00493636|Drug|Capecitabine|Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
12013252|NCT00493623|Drug|Placebo|Placebo i.v. single dose
12013253|NCT00493623|Drug|ibandronate [Bonviva/Boniva]|3mg i.v. single dose
12013254|NCT00493610|Drug|N-acetylcysteine(Mucomyst)|
12013255|NCT00493584|Procedure|Primary Percutaneous Coronary Intervention|Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
12013256|NCT00493584|Procedure|Coronary angiography / Percutaneous coronary intervention|Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
12013257|NCT00493571|Drug|Gimatecan|Starting dose: 0.6 mg capsules administered orally once daily.
12013258|NCT00493558|Device|Trabecular Metal Intervertebral Cage with RSA beads|Roentgen Stereophotogrammetric Analysis beads will be inserted at time of implant of the Trabecular Metal Intervertebral Cage.
12013259|NCT00493545|Biological|HspE7 and Poly-ICLC|3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections
12013260|NCT00493532|Drug|ibandronate [Bonviva/Boniva]|3mg iv every 3 months
12013261|NCT00493519|Procedure|chocolate cake|
12013262|NCT00493506|Drug|ProAlgaZyme|
12013263|NCT00493493|Procedure|surgery (Pore Excision, Curettage, and Injection of Cymetra)|
12013264|NCT00493480|Drug|carvedilol|6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 25 mg carvedilol daily.
12013265|NCT00493480|Drug|propranolol|80 mg of propranolol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubles weekly up to a maximum of 360 mg propranolol daily
12013266|NCT00493467|Drug|Ibritumomab Tiuxetan (Zevalin)|"111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1.
~90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8."
12013267|NCT00493467|Drug|Rituximab|250 mg/m^2 Intravenously Over 4-6 Hours On Days 1 and 8.
12013268|NCT00493454|Drug|Zevalin|.3 mCi IV Over 10 Minutes x 1 Day
12013269|NCT00493454|Drug|Rituximab|250 mg/m^2 IV Over 6 to 8 Hours
12013270|NCT00493454|Drug|^111 In Ibritumomab Tiuxetan|1.6 mg IV Over 10 Minutes x 1 Day
12013271|NCT00493441|Drug|AVN944|150, 200, 250, 300, or 400 mg q12h
12013272|NCT00493428|Drug|Baclofen|Patients will receive an initial dose of: 5 mg tid to be increased as tolerated to a maximum dose of 20 mg qid. This dose range and schedule reflects that suggested for the drug's muscle relaxant properties in human.
12013273|NCT00493415|Drug|nitroglycerin iv|loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes
12013274|NCT00493415|Drug|placebo = nacl 0.9%|4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes
12013275|NCT00493402|Procedure|Transarterial chemoembolization (TACE)|drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
12013276|NCT00493402|Procedure|Transarterial chemoembolization (TACE)|drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
12013277|NCT00493402|Procedure|Transarterial chemoembolization (TACE)|Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
12013278|NCT00493389|Drug|Adrenocorticotrophic hormone|
12013279|NCT00493376|Procedure|Cervical tissue biopsy analysis: Comet assay|Cervical tissue biopsy analysis: Comet assay
12013280|NCT00493376|Procedure|Biopsy: Measurement of histone gamma H2AX phosphorylation|Biopsy: Measurement of histone gamma H2AX phosphorylation
12013281|NCT00493376|Procedure|Biopsy: Immunohistochemistry: Ca9, Glut1, HIF-1 alpha|Biopsy: Immunohistochemistry: Ca9, Glut1, HIF-1 alpha
12013282|NCT00493376|Procedure|Measurement of vascular perfusion: contrast enhanced MRI|contrast enhanced MRI
12013283|NCT00493363|Drug|Artesunate|Artesunate 2 mg/kg/day for 7 days
12013284|NCT00493363|Drug|Artesunate + Mefloquine|Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4
12013288|NCT00493324|Drug|alefacept|Intramuscular
12013289|NCT00493324|Drug|polyvalent pneumococcal vaccine|Injection
12013290|NCT00493311|Drug|IV Placebo|IV Placebo
12013291|NCT00493311|Drug|IV Acetaminophen|Intravenous acetaminophen solution 1 g / 100 ml
12013292|NCT00493311|Biological|Reference Standard Endotoxin (RSE)|Administration of Reference Standard Endotoxin (RSE) to induce fever. Applicable to both study arms: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.
12013293|NCT00493298|Drug|natalizumab|According to the local prescribing information
12013294|NCT00493285|Biological|MEDI-534|Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
12013295|NCT00493285|Biological|MEDI-534|Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
12013296|NCT00493285|Biological|MEDI-534|Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
12013297|NCT00493272|Drug|Fibrinogen|Fibrinogen behandling
12013298|NCT00493259|Behavioral|Health-Related Quality of Life instrument|Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome
12013299|NCT00493259|Behavioral|Depression Scale for Children (CES-DC)|questionnaire
12013300|NCT00493246|Drug|IV Acetaminophen|"This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)
~Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen"
12013301|NCT00493246|Drug|IV Acetaminophen|"This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)
~Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen"
12013302|NCT00493233|Drug|2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine)|"Primary antipsychotic medication (olanzapine, oral risperidone, seroquel, clozapine, haldol, perphenazine) will be determined by the treating physician and participants will continue taking the concomitant antipsychotic drug. The dose of the main antipsychotic drug will remain open and flexible at the discretion of the attending physician. The dose of the second antipsychotic drug will remain fixed throughout the study period."
12013303|NCT00493233|Drug|main antipsychotic medication and placebo|"The main antipsychotic drug will be determined by the treating physician. Participants will be allocated to placebo in place of the concomitant antipsychotic drug. The dose of the main antipsychotic drug will remain open and flexible at the discretion of the attending physician."
12013304|NCT00493220|Drug|SC HYLENEX and Ceftriaxone|single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
12013305|NCT00493220|Drug|SC Placebo and Ceftriaxone|single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
12013306|NCT00493220|Drug|IV Ceftriaxone|single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
12013307|NCT00493194|Drug|sirolimus|
12013308|NCT00493194|Drug|cyclosporine|
12013309|NCT00493194|Drug|daclizumab|
12013310|NCT00493181|Drug|Interleukin-11 (IL-11 or Neumega)|10 mcg/kg under the skin (usually of the arms, legs or abdomen) three times weekly. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of injections may be increased.
12013311|NCT00493155|Drug|RG1530|Administered po at escalating doses (10 cohorts)
12013312|NCT00493142|Behavioral|Exercise|physical therapy home exercise
12013313|NCT00493129|Drug|Ontak (Denileukin Diftitox)|9 µg/kg by vein Days 1-5 of a 21 day cycle.
12013314|NCT00493116|Drug|Interferon-beta-1a|dosage and frequency as per Biogen Idec protocol
12013315|NCT00493116|Drug|methylprednisolone|dosage and frequency as per Biogen Idec protocol
12013316|NCT00493090|Behavioral|modification of an interactive seminar|
12013317|NCT00493077|Drug|low immunogenic interferon-beta-1a|dosage and frequency as per Biogen Idec protocol
12013318|NCT00493064|Drug|Nicotinic acid|topical eye drops
12013319|NCT00493064|Drug|Prednisolone acetate|topical eye drops
12013320|NCT00493051|Biological|GAM501|Ad5PDGF-B formulated in a collagen gel
12013321|NCT00493051|Biological|Placebo|Collagen gel
12013322|NCT00493051|Other|Standard of care|moist dressing changes daily
12013323|NCT00493038|Drug|Moxifloxacin (Avelox, BAY12-8039)|Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
12013324|NCT00493038|Drug|Amoxicillin/Clavulanate|Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
12013325|NCT00493025|Drug|cisplatin|Cisplatin IV
12013326|NCT00493025|Drug|gefitinib|Gefitinib IV
12013327|NCT00493025|Drug|paclitaxel|Paclitaxel IV
12013328|NCT00493025|Procedure|adjuvant therapy|Postoperative ZD1839
12013329|NCT00493025|Radiation|radiation therapy|Radiotherapy
12013330|NCT00493012|Dietary Supplement|vitamin D|6 drops of a vitamin D containing oil
12013331|NCT00492999|Drug|dexamethasone|Given by hepatic arterial infusion
12013332|NCT00492999|Drug|floxuridine|Given by hepatic arterial infusion
12013333|NCT00492999|Drug|fluorouracil|Given IV
12013334|NCT00492999|Drug|irinotecan hydrochloride|Given IV
12013335|NCT00492999|Drug|leucovorin calcium|Given IV
12013336|NCT00492999|Drug|oxaliplatin|Given IV
12013337|NCT00492986|Drug|Nexavar (Sorafenib, BAY43-9006)|Multikinase inhibitor: Sorafenib mono therapy 400 mg bid
12013338|NCT00492973|Drug|methylprednisolone acetate|Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
12013339|NCT00492973|Drug|active comparator|bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
12013340|NCT00492960|Drug|larazotide acetate|gelatin capsules
12013341|NCT00492960|Drug|placebo|gelatin capsules
12013342|NCT00492960|Dietary Supplement|900 mg gluten|gelatin capsules
12013343|NCT00492947|Biological|dendritic cell vaccine|3 vaccinations total: Day 10, Day 20, Day 30
12013344|NCT00492934|Drug|human menopausal gonadotrophins|Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation
12013345|NCT00492921|Drug|Cyclophosphamide|
12013346|NCT00492908|Device|Helistent Titan2 (Titanium coated stent)|Titan2
12013347|NCT00492908|Device|EndeavorTM (Zotarolimus-Eluting Stent)|Endeavor
12013348|NCT00492895|Drug|Discontinuation of Azathioprin|Discontinuation of Azathioprin
12013349|NCT00492882|Drug|usual administration of exogenous recombinant FSH|
12013350|NCT00492869|Drug|AEB071|
12013351|NCT00492856|Drug|mercaptopurine|Given orally
12013352|NCT00492856|Drug|methotrexate|Given orally
12013353|NCT00492856|Drug|tretinoin|Given orally
12013354|NCT00492843|Drug|Ibandronate (Bondronat)|Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
12013355|NCT00492830|Drug|TRC093 recombinant humanized IgG1k monoclonal antibody|TRC093 is a humanized monoclonal antibody to cleaved collagen administered i.v. on days 1 and 15 of each 28 day cycle until pregression or unacceptable toxicity develops.
12013356|NCT00492817|Procedure|Stereotactic Body Radiotherapy|On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
12013357|NCT00492804|Procedure|Lichtenstein hernia repair|Lichtenstein hernia repair with tension free mesh
12013358|NCT00492804|Procedure|Neurectomy|Neurectomy
12013359|NCT00492791|Device|wireless endoscopy capsule|Firslty patency ingestion then wireless endoscopy capsule exam done
12013360|NCT00492778|Radiation|3-Dimensional Conformal Radiation Therapy|Given to the pelvis
12013361|NCT00492778|Drug|Cisplatin|Given IV
12013362|NCT00492778|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
12013363|NCT00492778|Radiation|Internal Radiation Therapy|Given intracavitarily or interstitially
12013364|NCT00492765|Drug|Interferon-beta-1a|dosage and frequency as per label
12013365|NCT00492765|Drug|Simvastatin|dosage and frequency as per Biogen Idec protocol
12013366|NCT00492765|Drug|Placebo|dosage and frequency the same as simvastatin as per Biogen Idec Protocol
12013367|NCT00492752|Drug|Sorafenib (Nexavar, BAY43-9006)|multikinase inhibitor; Sorafenib 400 mg (orally) twice daily
12013368|NCT00492752|Drug|Placebo|Matching placebo (orally) twice daily
12013369|NCT00492739|Biological|Vaccination with VZV vaccine|Varicella vaccination 2 doses 2 months apart.
12013370|NCT00492726|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin, 400mg, administered intravenously once daily
12013371|NCT00492726|Drug|Ertapenem intravenous|Active treatment: Ertapenem 1.0g, administered intravenously once daily
12013372|NCT00492713|Other|dark chocolate|dark chocolate
12013373|NCT00492713|Other|Milk chocolate 1|Milk chocolate 1
12013374|NCT00492713|Other|Milk chocolate 2|Milk chocolate 2
12013375|NCT00492700|Drug|rosiglitazone|
12013376|NCT00492687|Drug|carboplatin|
12013377|NCT00492687|Drug|tamoxifen citrate|
12013378|NCT00492687|Drug|temozolomide|
12013379|NCT00492687|Procedure|adjuvant therapy|
12013380|NCT00492687|Radiation|radiation therapy|
12013381|NCT00492674|Device|APOS biomechanical gait system|
12013382|NCT00492674|Procedure|Physical Therapy|
12013383|NCT00492661|Drug|Tacrolimus With Diet and Exercise Intervention|Participants on tacrolimus for immunosuppression will be provided with intensive dietary advice and supervised for a period of 6 months. Dosage and administration of tacrolimus will be as per Investigator's discretion.
12013384|NCT00492648|Procedure|Blood sampling for assay of persistence of immunogenicity|Two blood samples: 30 and 42 months after first vaccination
12013385|NCT00492635|Drug|Levitra (Vardenafil, BAY38-9456)|9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
12013386|NCT00492635|Drug|Levitra (Vardenafil, BAY38-9456)|9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
12013387|NCT00492635|Drug|Placebo|9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication
12013388|NCT00492622|Drug|Immediate-release omeprazole|Immediate-release omeprazole 40 mg qam for 7 days
12013389|NCT00492622|Drug|Delayed-release omeprazole|Delayed-release omeprazole 40 mg qam for 7 days
12013390|NCT00492596|Device|AttenueX IntraVesical System|Insertion of the Solace AttenueX Intravesical System on Day 0
12013391|NCT00492596|Procedure|Sham Procedure|Cystoscopy with Simulated Insertion of AttenuEX Intravescial System
12013392|NCT00492583|Drug|Bifidobacterium lactis (BB-12)|The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin).
12013393|NCT00492583|Drug|Placebo|The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.
12013394|NCT00492557|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.
12013395|NCT00492557|Biological|13vPnC + TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.
12013466|NCT00492167|Other|laboratory biomarker analysis|
12013396|NCT00492544|Biological|Cervarix™ (HPV-16/18 L1 VLP AS04)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12013397|NCT00492531|Drug|Sildenafil|Oral Sildenafil 20mg three times daily for 6 weeks,followed by 40mg three times daily for 4 weeks followed by 80mg three times daily for 6 weeks.
12013398|NCT00492531|Drug|Placebo|Placebo 20mg three times daily for 6 weeks,followed by 40mg three times daily for 4 weeks followed by 80mg three times daily for 6 weeks.
12013399|NCT00492518|Drug|Acetylcysteine|
12013400|NCT00492518|Drug|Theophylline|
12013401|NCT00492518|Drug|Placebo|
12013402|NCT00492505|Drug|cisplatin|
12013403|NCT00492505|Drug|sorafenib tosylate|
12013404|NCT00492505|Drug|tamoxifen citrate|
12013405|NCT00492505|Procedure|adjuvant therapy|
12013406|NCT00492492|Procedure|trans-styloid and intrafocal pinning on the one side|
12013407|NCT00492492|Procedure|volar fixed-angle plating on the other side|
12013408|NCT00492479|Drug|Kinerase Pro+Therapy Line day repair, serum, night repair|
12013409|NCT00492479|Drug|Kinerase Pro+Therapy Line Ultra rich day repair|
12013410|NCT00492479|Drug|LubriDerm|
12013411|NCT00492466|Drug|Interferon-beta-1a|dosage and frequency as per label
12013412|NCT00492466|Drug|methylprednisolone|dosage and frequency as per Biogen Idec protocol
12013413|NCT00492453|Procedure|laparoscopic cholecystectomy|elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
12013414|NCT00492440|Biological|recombinant interleukin-7|
12013415|NCT00492440|Genetic|gene expression analysis|
12013416|NCT00492440|Genetic|polymerase chain reaction|
12013417|NCT00492440|Genetic|protein expression analysis|
12013418|NCT00492440|Other|flow cytometry|
12013419|NCT00492440|Other|immunoenzyme technique|
12013420|NCT00492440|Other|immunologic technique|
12013421|NCT00492440|Other|laboratory biomarker analysis|
12013422|NCT00492440|Other|pharmacological study|
12013423|NCT00492427|Drug|R744|25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25~250μg(s.c.)/4week for 24~26weeks in total.
12013424|NCT00492427|Drug|Epoetin beta|6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k~12000IU(s.c.)/2week for 24~26weeks in total.
12013425|NCT00492414|Drug|Paroxetine CR|
12013426|NCT00492401|Drug|decitabine|Given IV
12013427|NCT00492401|Other|laboratory biomarker analysis|Correlative studies
12013428|NCT00492401|Other|pharmacological study|Correlative studies
12013429|NCT00492401|Other|high performance liquid chromatography|Correlative studies
12013430|NCT00492401|Genetic|microarray analysis|Correlative studies
12013431|NCT00492401|Genetic|RNA analysis|Correlative studies
12013432|NCT00492401|Other|mass spectrometry|Correlative studies
12013433|NCT00492401|Genetic|DNA methylation analysis|Correlative studies
12013434|NCT00492401|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|Correlative studies
12013435|NCT00492388|Drug|PMI-150 (intranasal ketamine)|intranasal dosing
12013436|NCT00492388|Drug|placebo|placebo
12013437|NCT00492362|Behavioral|ergometer exercise during hemodialysis|
12013438|NCT00492362|Behavioral|pedometer activity outside of hemodialysis|
12013439|NCT00492349|Drug|Varenicline|Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
12013440|NCT00492349|Drug|Placebo|Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
12013441|NCT00492336|Drug|rasagiline (Pharmacodynamics)|Rasagiline 1 mg/day for 12 weeks
12013442|NCT00492336|Drug|Placebo|Placebo 1 tablet each day
12013443|NCT00492323|Drug|placebo|twice daily for 4 weeks
12013444|NCT00492323|Drug|carisbamate|200 mg tablet twice daily for 4 weeks
12013445|NCT00492310|Behavioral|yoga|vinyasa yoga
12013446|NCT00492310|Behavioral|cognitive therapy|cognitive behavioral therapy once weekly
12013447|NCT00492310|Behavioral|yoga|vinyasa yoga twice weekly with smoking cessation once weekly
12013448|NCT00492310|Behavioral|wellness|wellness program with smoking cessation
12013449|NCT00492297|Drug|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
12013450|NCT00492284|Drug|verteporfin|Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
12013451|NCT00492284|Drug|verteporfin|Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
12013452|NCT00492284|Drug|ranibizumab|0.5 mg intravitreal injection
12013453|NCT00492284|Drug|dexamethasone|0.5 mg intravitreal injection
12013454|NCT00492271|Drug|Friulimicin B|Intravenous, once daily, single dose
12013455|NCT00492258|Drug|sorafenib tosylate|
12013456|NCT00492258|Procedure|adjuvant therapy|
12013457|NCT00492245|Procedure|PTK with mitomycin in Adenoviral Opacities|
12013458|NCT00492232|Drug|Ramelteon and zolpidem|Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
12013459|NCT00492232|Drug|Placebo and zolpidem|Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
12013460|NCT00492219|Device|Vanguard M fixed-bearing or Oxford mobile-bearing prostheses|Patients that are appropriate for partial knee replacement will be randomized to receive one of these two FDA-approved implant systems.
12013461|NCT00492219|Device|Total Knee Replacement|Patients undergoing total knee replacement with the Vanguard Complete Knee implant system
12013462|NCT00492206|Drug|Cetuximab|The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.
12013463|NCT00492167|Biological|beta-glucan|
12013464|NCT00492167|Biological|monoclonal antibody 3F8|
12013465|NCT00492167|Other|immunohistochemistry staining method|
12013467|NCT00492141|Drug|Temozolomide|Cycle 2, Dose Level 1 = 100 mg/m^2 by mouth (PO) Daily, Days 1-5 Prior to L9-NC; Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, advance to 100 mg/m^2 PO Every 12 Hours, Days 1-5 Prior to L9-NC. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2; Cycle 4 and beyond = Patients will continue on dose level 1 or 2 as given in cycle 3.
12013468|NCT00492141|Drug|L9-NC|"Cycle 1 = Administered by aerosol 5 consecutive days per week for 2 weeks. A total of 10 ml of 0.4 mg/ml in an aerosol reservoir delivered over approximately 30 minutes per day given once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
~Cycle 2, Dose Level 1 = Week 1, doses 1-5 preceded by temozolomide. Continue L9-NC once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
~Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, due to drug, during cycle 2, L9-NC may be increased to twice daily, approximately 12 hours apart. Week 1, the morning dose on days 1-5 preceded by temozolomide. L9-NC will be given twice a day, 5 days a week, for 2 weeks, followed by 2 weeks off. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2.
~Cycle 4 and beyond, patients will continue on dose level 1 or 2 as given in cycle 3."
12013469|NCT00492128|Drug|Losartan/amlodipine or losartan/hydrochlorothiazide|Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.
12013470|NCT00492115|Device|Continuous positive airway pressure (CPAP)|therapeutic Continuous positive airway pressure (tCPAP) nightly for 6 weeks
12013471|NCT00492115|Device|Placebo CPAP|Ineffective Continuous positive airway pressure (pCPAP) for 3 weeks followed by therapeutic CPAP for 3 weeks
12013472|NCT00492102|Drug|Montelukast|One oral dose of Montelukast 0.15mg (infants weighing 500-1000gm) or 0.2mg (infants weighing >1000gm). Two blood samples will be obtained from each infant within 24 hours of the drug administration and plasma Montelukast levels will be determined.
12013473|NCT00492089|Drug|bevacizumab|Given IV
12013474|NCT00492089|Drug|placebo|Given IV
12013475|NCT00492089|Procedure|magnetic resonance imaging|
12013476|NCT00492089|Procedure|quality-of-life assessment|
12013477|NCT00492076|Biological|Pangramin Plus D. pteronyssinus 100%|"Active. Pangramin Plus D. pteronyssinus 100%
~Placebo. Pangramin Plus placebo"
12013478|NCT00492063|Biological|Cell culture-derived trivalent subunit influenza vaccine (cTIV)|One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
12013479|NCT00492063|Biological|Egg-derived trivalent subunit influenza vaccine (TIV)|One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle
12013480|NCT00492050|Drug|Bortezomib|1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.
12013481|NCT00492050|Drug|Rituximab|375 mg/m^2 IV on Day 8 and 22.
12013482|NCT00492050|Drug|Valacyclovir|500 mg orally daily (or acyclovir 200 mg orally twice daily)
12013483|NCT00492037|Drug|YM087 oral|
12013484|NCT00492024|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin - 400 mg once a day for 5 days
12013485|NCT00492024|Drug|Placebo|Placebo - 380 mg Microcrystalline Cellulose
12013486|NCT00492011|Drug|Ramelteon|Ramelteon 1 mg, tablets, orally, once nightly for 4 nights.
12013487|NCT00492011|Drug|Ramelteon|Ramelteon 4 mg, tablets, orally, once nightly for 4 nights.
12013488|NCT00492011|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once nightly for 4 nights.
12013489|NCT00492011|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once nightly for 4 nights.
12013490|NCT00491998|Drug|V1512|6 doses of IMP at 2-hourly intervals
12013491|NCT00491998|Drug|V1512|3-hourly dosing
12013492|NCT00491998|Drug|V1512 and Entacapone|4 doses of IMP and Entacapone at 3-hourly intervals
12013493|NCT00491985|Biological|A/H5N1 Inactivated, split-virion pandemic influenza vaccine|0.5 mL, Intramuscular
12013494|NCT00491985|Biological|A/H5N1 Inactivated, split virion pandemic influenza vaccine|0.5 mL, Intramuscular
12013495|NCT00491985|Biological|A/H5N1 Inactivated, split virion pandemic influenza vaccine|0.25 mL, Intramuscular
12013496|NCT00491959|Procedure|Cultured oral mucosa cell sheet transplantation|Cultivated oral mucosal cell sheets will be transplanted on the denuded corneal surface or the scleral surface of the symblepharon area. Therapeutic contact lenses will be applied after surgery.
12013497|NCT00491946|Drug|Actinomycin-D|
12013498|NCT00491946|Drug|Vincristine|
12013499|NCT00491933|Procedure|Quantiferon-TB Gold assay|
12013500|NCT00491933|Procedure|Tuberculin skin test|
12013501|NCT00491920|Drug|cholecalciferol (Vitamin D3)|"20 000 Iu x2/week
~+ calcium 500 mg/cholecalciferol 400 IU x2/d"
12013502|NCT00491920|Drug|placebo|Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
12013503|NCT00491907|Drug|folic acid 5mg/day|
12013504|NCT00491894|Drug|Oral Glycopyrrolate Liquid|Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver
12013505|NCT00491881|Behavioral|no added salt diet|
12013506|NCT00491868|Drug|R744|100μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
12013507|NCT00491868|Drug|R744|150μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
12013508|NCT00491868|Drug|rHuEPO|2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
12013509|NCT00491868|Drug|rHuEPO|4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
12013510|NCT00491868|Drug|R744 placebo|0 μg/4week for 24 weeks
12013511|NCT00491868|Drug|rHuEPO placebo|0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks
12013512|NCT00491855|Drug|Bevacizumab|Starting dose level 2.5 mg/kg given intravenously on day 1.
12013513|NCT00491855|Drug|Oxaliplatin|Starting dose level 25 mg/m^2 given intraperitoneally on day 2.
12013514|NCT00491855|Drug|Paclitaxel|Starting dose level 110 mg/m^2 given continuous infusion on day 1 and 30 mg/m^2 given intraperitoneally on day 8.
12013515|NCT00491829|Drug|50 mg qhs|flibanserin 50 mg
12013516|NCT00491829|Drug|100 mg|flibanserin 100mg
12013517|NCT00491829|Drug|placebo|placebo
12013518|NCT00491816|Drug|Erlotinib with neoadjuvant chemotherapy|150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy
12013519|NCT00491803|Drug|Sildenafil|sildenafil 20 mg orally
12013520|NCT00491803|Drug|Sildenafil|sildenafil 40 mg orally
12013521|NCT00491790|Drug|Montelukast|Montelukast 4 mg rapid dissolving granules in sterile water given orally once
12013522|NCT00491790|Other|Sterile water|Sterile water
12013523|NCT00491777|Device|Noninvasive Hemodynamic Patient Monitor|
12013524|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.
12013525|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
12013526|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
12013527|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
12013528|NCT00491764|Drug|Terbinafine|Terbinafine 250 mg QD for 12 weeks.
12013529|NCT00491764|Drug|Placebo|Placebo for 24 weeks.
12013530|NCT00491751|Drug|atorvastatin|atorvastatin 40 or 80 mg/day
12013531|NCT00491751|Drug|ascorbic acid|ascorbic acid 500 mg/day
12013532|NCT00491751|Drug|Placebo|matching placebo
12013533|NCT00491738|Drug|bevacizumab|Intravenous repeating dose
12013534|NCT00491738|Drug|sunitinib|Oral repeating dose
12013535|NCT00491738|Drug|placebo|Intravenous repeating dose
12013536|NCT00491725|Drug|repaglinide|
12013537|NCT00491725|Drug|metformin|
12013538|NCT00491712|Procedure|Glaucoma drainage implant with/without triamcinolone|
12013539|NCT00491699|Drug|XL999|XL999 will be administered as a once-weekly 4 hour IV infusion as a single agent. The first cohort will be dosed at 0.4 mg/kg IV once weekly. The maximum dose cohort will not exceed 1.6 mg/kg IV once weekly. Ten subjects are planned for each dosing cohort, with dose escalation dependent on safety and available PK data from prior cohorts
12013540|NCT00491686|Drug|AZD6765|intravenous infusion
12013541|NCT00491673|Procedure|Uncemented primary bipolar hemiarthroplasty of the hip|Uncemented primary bipolar hemiarthroplasty of the hip
12013542|NCT00491673|Procedure|Cemented primary bipolar hemiarthroplasty of the hip|Cemented primary bipolar hemiarthroplasty of the hip
12013543|NCT00491660|Behavioral|supine positioning|
12013544|NCT00491660|Behavioral|lateral positioning|
12013545|NCT00491634|Drug|treosulfan|12 g/m2 x 3 days
12013546|NCT00491634|Drug|Treosulfan|12 g/m2 x 3
12013547|NCT00491621|Procedure|surgery or biopsy of the kidney tumor|surgery or biopsy of the kidney tumor
12013548|NCT00491608|Biological|rThrombin|1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder
12013549|NCT00491595|Drug|High Dose Soy isoflavones|
12013550|NCT00491582|Drug|Growth hormone replacement therapy in growth hormone deficient patients only.|Genotropin once/daily sc., titration scheme according to the consensus guidelines of the GH and IGF-research society Duration: 6 months
12013551|NCT00491569|Drug|Sarcosine and D-serine|
12013552|NCT00491556|Procedure|Early Initiation of Highly Active Anti-Retroviral Therapy|Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
12013553|NCT00491556|Procedure|Standard Care|Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years.
12013554|NCT00491543|Drug|ALT-2074|
12013555|NCT00491530|Drug|ABT-335|Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
12013556|NCT00491530|Drug|rosuvastatin calcium|Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
12013557|NCT00491530|Drug|simvastatin|Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
12013558|NCT00491530|Drug|atorvastatin calcium|Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
12013559|NCT00491517|Drug|Sirolimus|Patients will be given Sirolimus starting at the oral daily dose of 3 mg with periodically whole blood level measurements. The daily dose will be adjusted to keep sirolimus concentration within 10-15 ng/ml.
12013560|NCT00491517|Drug|conventional therapy|Antihypertensive drugs for patients with high blood pressure.
12013561|NCT00491504|Drug|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
12013562|NCT00491504|Other|Placebo|Placebo: 2 sprays in each nostril
12013563|NCT00491491|Drug|ibritumomab tiuxetan|0.4 mCi/kg
12013564|NCT00491491|Procedure|BEAM chemotherapy and autologous stem-cell transplantation|
12013565|NCT00491478|Drug|sertraline|
12013566|NCT00491465|Behavioral|Intensive Physical activity|
12013567|NCT00491465|Behavioral|Control- regular physical activity|
12013568|NCT00491426|Drug|Ampicillin|Drug prescribed per routine medical care.
12013569|NCT00491426|Drug|Metronidazole|Drug prescribed per routine medical care.
12013570|NCT00491426|Drug|Piperacillin/Tazobactam|Drug prescribed per routine medical care.
12013571|NCT00491426|Drug|Acyclovir|Drug prescribed per routine medical care.
12013572|NCT00491426|Drug|Amphotericin B|Drug prescribed per routine medical care.
12013573|NCT00491426|Drug|Ambisome|Drug prescribed per routine medical care.
12013574|NCT00491426|Drug|Anidulafungin|Drug prescribed per routine medical care.
12013575|NCT00491426|Drug|Caspofungin|Drug prescribed per routine medical care.
12013576|NCT00491413|Drug|epoetin|
12013577|NCT00491400|Drug|Fenofibrate|140 mg/day for 8 weeks
12013578|NCT00491400|Drug|Atorvastatin|20 mg/day for 8 weeks
12013579|NCT00491387|Drug|Metoprolol Succinate|Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.
12013580|NCT00491374|Drug|Mometasone Furoate Nasal Spray|Nasonex Nasal Spray 50 mcg/spray, 200 mcg (4 sprays) once daily every morning for 28 days.
12013581|NCT00491374|Drug|Placebo|Placebo Nasal Spray 4 sprays once daily every morning for 28 days.
12013582|NCT00491348|Drug|duloxetine hydrochloride|duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks
12013583|NCT00491322|Dietary Supplement|Ergocalciferol|Ergocalciferol 50000 international units once a week for 12 weeks
12013584|NCT00491322|Dietary Supplement|Ergocalciferol placebo|Ergocalciferol placebo once a week for 12 weeks
12013585|NCT00491309|Behavioral|exercise training|exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)
12013586|NCT00491296|Device|SYNERGO|
12013587|NCT00491296|Device|SYNERGO-intravesical chemotherapy instillation combined with hyperthermia|
12013588|NCT00491283|Device|Swab Specimen Collection (QuickVue)|
12013589|NCT00491270|Device|VS Sense|An applicator to diagnose pH increase above 5.2
12013590|NCT00491257|Biological|Inactivated influenza vaccine (split virion) NH 2007-2008 formulation|0.5 mL, Intramuscular
12013591|NCT00491244|Drug|Peginterferon alfa-2a and ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
12013592|NCT00491244|Drug|Peginterferon alfa-2a|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
12013593|NCT00491192|Drug|Diclofenac|
12013594|NCT00491179|Drug|Pegylated interferon alfa-2a and ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
12013595|NCT00491179|Drug|Pegylated interferon alfa-2a and ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
12013596|NCT00491166|Drug|Bromfenac ophthalmic solution|
12013597|NCT00491140|Genetic|Gene mutations analysis and FISH|FISH and mutation analysis of multiple genes
12013598|NCT00491127|Drug|gemcitabine|
12013599|NCT00491127|Drug|cisplatin|
12013600|NCT00491127|Drug|dexamethasone|
12013601|NCT00491114|Drug|Gemcitabine|
12013602|NCT00491101|Other|Polish Version of PAQLQ(S) by Juniper|Polish Version of PAQLQ(S) by Juniper
12013603|NCT00491101|Other|spirometry|spirometry
12013604|NCT00491088|Device|CPAP|CPAP for 12 weeks
12013605|NCT00491075|Drug|Pemetrexed|500 mg/m^2 IV Over 10 Minutes on Day 1.
12013606|NCT00491075|Drug|Gemcitabine|1500 mg/m^2 IV Over 30 Minutes on Day 1, Immediately After Infusion of Pemetrexed.
12013607|NCT00491062|Procedure|Biopsies|
12013608|NCT00491049|Drug|0.5% levofloxacin eye drops|
12013609|NCT00491036|Device|Intraaortic balloon pump|intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
12013610|NCT00491010|Procedure|radiofrequency catheter ablation|
12013611|NCT00490997|Drug|Ketamine only|"Ketamine 1.0 mg/kg IV and placebo intralipid as initial sedation agents (double blinded).
~Ketamine .25 mg/kg IV and placebo intralipid q2 minutes prn for additional sedation"
12013612|NCT00490997|Drug|Ketamine - Propofol|"Ketamine .5 mg/kg and Propofol 1 mg/kg as initial sedation agents (double-blinded).
~Saline Placebo and Propofol .5 mg/kg q 2minutes for additional sedation"
12013613|NCT00490984|Device|Aspire Medical Advance System|The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.
12013614|NCT00490971|Drug|Olanzapine|Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence
12013615|NCT00490971|Drug|Paliperidone ER|Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence
12013616|NCT00490971|Drug|Placebo|Once daily until recurrence (only after initial 15 weeks on paliperidone ER)
12013617|NCT00490958|Drug|telmisartan|
12013618|NCT00490945|Drug|VEC-162|
12013619|NCT00490932|Drug|Hypo-osmolar ORS|
12013620|NCT00490919|Drug|Buprenorphine transdermal system|Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days
12013621|NCT00490919|Drug|Placebo|transdermal system (placebo) worn for 7 days
12013622|NCT00490906|Drug|Copaxone|20 mg, subcutaneous injections, taken daily
12013623|NCT00490906|Drug|Interferon-beta 1a|30 mcg injected intramuscularly, once weekly
12013624|NCT00490906|Drug|Interferon-beta 1b|.25 mg/day, taken every other day, subcutaneous injections
12013625|NCT00490893|Drug|Detemir|
12013626|NCT00490880|Drug|gemcitabine|
12013627|NCT00490880|Drug|cisplatin|
12013628|NCT00490880|Procedure|radical cystectomy|
12013629|NCT00490880|Procedure|radiotherapy|
12013630|NCT00490867|Drug|Alpha lipoic acid|
12013631|NCT00490854|Drug|Human Insulin Inhalation Powder|patient specific, inhaled, at meals, 76 weeks
12013632|NCT00490854|Drug|Neutral protamine hagedorn insulin|patient specific dose, injected, daily, 76 weeks
12013633|NCT00490841|Device|Herculink Elite Renal Stent System|This is a prospective, non-randomized, single arm, multi-center study to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with sub-optimal renal PTA results in de novo or restenotic renal artery lesions. Patients who satisfy the inclusion/exclusion criteria will be enrolled at sites in the United States. Patients will have follow up visits for evaluation.
12013634|NCT00490828|Drug|Hydrocortisone|Hydrocortisone
12013635|NCT00490815|Drug|Fluocinolone Acetonide|0.5 mg fluocinolone acetonide intravitreal insert
12013636|NCT00490815|Drug|Fluocinolone Acetonide|0.2 mg fluocinolone acetonide intravitreal insert
12013637|NCT00490802|Drug|Oxytocin|Intranasal Oxytocin
12013638|NCT00490802|Drug|Placebo|Placebo Comparator
12013639|NCT00490789|Drug|sirolimus|daily oral sirolimus with dosage individualised by trough blood levels
12013640|NCT00490776|Drug|LBH589|
12013641|NCT00490763|Behavioral|Survey|7 surveys at the beginning of the study and again every 6 months about diet, coping with the disease, and quality of life.
12013642|NCT00490750|Procedure|Dor fundoplication|Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication
12013643|NCT00490750|Procedure|Toupet fundoplication|Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication
12013644|NCT00490737|Drug|daptomycin|6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses
12013645|NCT00490724|Drug|Nesiritide (1+0.01)|Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 15.4 to 35.2 mcg/kg.
12013646|NCT00490724|Drug|Nesiritide (2+0.005)|Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 9.2 to 31.7 mcg/kg.
12013647|NCT00490724|Drug|Nesritide (2+0.01)|Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 16.4 to 36.2 mcg/kg.
12013648|NCT00490711|Drug|gemcitabine|
12013649|NCT00490711|Drug|carboplatin|
12013650|NCT00490711|Drug|paclitaxel|
12013651|NCT00490698|Drug|Zoledronate|4 mg IV Once Every 4 Weeks
12013652|NCT00490698|Drug|Atorvastatin|20 mg PO Daily
12013653|NCT00490685|Drug|Sorafenib (BAY-43-9006)|
12013654|NCT00490672|Behavioral|No Active Intervention.|Conventional Chronic Disease Management in Malaysia Primary Care
12013655|NCT00490672|Behavioral|Community Based Multiple Risk Factor Intervention Strategies|Multi-faceted Intervention in Chronic Diseases Management i.e. Hypertension, Diabetes Mellitus, Hyperlipidaemia involving Primary Health Care Physicians, Nurse Educators, Dieticians and Pharmacists.
12013656|NCT00490659|Drug|gemcitabine|
12013657|NCT00490659|Drug|cisplatin|
12013658|NCT00490659|Procedure|radical surgery|
12013659|NCT00490659|Procedure|chemoradiotherapy|
12013660|NCT00490646|Drug|ixabepilone|"Ixabepilone 40 mg/m^2 was administered as a 3-hour I.V. continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity.
~For the first cycle, ixabepilone was administered the day following the first dose of trastuzumab (in the first cycle trastuzumab was given on Day 0); in all the following cycles, ixabepilone was administered immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated."
12013661|NCT00490646|Drug|docetaxel|Docetaxel 100 mg/m^2 was administered as a 1-hour IV continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity. For the first cycle, docetaxel was administered the day following the first dose of trastuzumab (i.e. in the first cycle trastuzumab was given on Day 0); in all following cycles, docetaxel was administered immediately after trastuzumab if the preceding dose of trastuzumab was well tolerated.
12013662|NCT00490646|Drug|trastuzumab|Trastuzumab was administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle at a dose of 2 mg/kg until disease progression or unacceptable toxicity. In cycle 1, a loading dose of 4 mg/kg was administered as a 90-minute IV infusion on a day before initial administration of chemotherapy (i.e. on Day 0). Trastuzumab was given immediately prior to ixabepilone (Arm A) or docetaxel (Arm B) in all subsequent cycles as a 30-minute IV infusion if the initial dose was well tolerated.
12013663|NCT00490633|Behavioral|Ear Loop Procedure Mask|Facemasks were requested to be worn while participants were in the residence hall for year one, and while they were in residence halls for a minimum of six hours per day in year two.
12013664|NCT00490633|Behavioral|62% Ethyl Alcohol Hand Sanitizer|Hand sanitizer was provided to participants in the facemask and hand hygiene arm for year one and year two of the study.
12013665|NCT00490620|Drug|Combination antiviral therapy|Zidovudine 300mg and lamivudine 150mg BID for 6 months
12013666|NCT00490620|Drug|Placebo|placebo BID for 6 months
12013667|NCT00490594|Device|ACL Reconstruction (SeriACL™ Device)|Bioresorbable ACL
12013668|NCT00490581|Other|case management and supportive housing|patients randomized to the study group are offerred respite care/interim housing and case management upon discharge from enrolling hospitalization. They are also offerred stable housing within 90 days of enrolling hospital discharge, with case management at all 3 stages - hospital, respite care/interim housing, and stable housing.
12013669|NCT00490568|Drug|Rosiglitazone XR|Experimental drug
12013670|NCT00490555|Drug|Testosterone gel|Testosterone gel 10 g
12013671|NCT00490555|Drug|Dutasteride|dutasteride 0.5 mg orally
12013672|NCT00490555|Drug|Depo-Medroxyprogesterone (DMPA)|300 mg DMPA injection on Day 0 IM (into the muscle)
12013673|NCT00490555|Other|Placebo Testosterone gel|Place gel applied daily for 12 weeks
12013674|NCT00490555|Other|Placebo dutasteride|placebo pill for 12 weeks
12013675|NCT00490555|Other|Placebo DMPA|placebo DMPA injection Once
12013676|NCT00490542|Drug|ziprasidone (Geodon)|ziprasidone, geodon. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.
12013677|NCT00490542|Drug|placebo|Placebo, sugar pill arm. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.
12013678|NCT00490529|Biological|CpG-MCL vaccine|CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection.
12013679|NCT00490529|Biological|PF-3512676|PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. PF-03512676 acts as an agonist of human Toll-like receptor 9, leading to activation of antigen-presenting cells and a cascade of antitumor immune reactions.
12013680|NCT00490529|Procedure|Vaccine-primed T-cells|Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells.
12013787|NCT00489710|Procedure|non-specific immune-modulator therapy|
12013681|NCT00490529|Procedure|Autologous hematopoietic stem cell transplant (HSCT)|Regular medical procedure
12013682|NCT00490529|Drug|Rituximab|375 mg/m² by infusion
12013683|NCT00490529|Drug|Standard induction chemotherapy|Patient-specific, regular medical care treatment as determined by treating oncologist
12013684|NCT00490529|Drug|Cyclophosphamide|Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
12013685|NCT00490529|Drug|Filgrastim|Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
12013686|NCT00490516|Drug|ACP-104|200 mg, tablet, BID, 6 weeks
12013687|NCT00490516|Drug|ACP-104|100 mg, tablet, BID, 6 weeks
12013688|NCT00490516|Drug|Placebo|placebo, tablet BID, 6 weeks
12013689|NCT00490503|Procedure|Magnetic Resonance Imaging (MRI)|3 Scans performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
12013690|NCT00490503|Procedure|Magnetic Resonance Spectroscopy (MRS)|3 MRI Scans with MRS performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
12013691|NCT00490490|Drug|Bexxar (tositumomab)|Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.
12013692|NCT00490490|Procedure|External beam radiotherapy (XRT)|Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.
12013693|NCT00490490|Drug|Potassium Iodide (KI)|"Potassium iodide (KI) will be administered as:
~Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day,
~Lugol's solution 20 drops orally 3-times-a-day, OR
~KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab"
12013694|NCT00490477|Device|Polymyxin -B fiber hemoperfusion system|two hours treatment for two days
12013695|NCT00490464|Drug|Nicardipine and Nipride|
12013696|NCT00490451|Drug|LY573636-sodium|LY573636 dose is dependent on patient's height, weight, and gender to target a specific maximum concentration (Cmax). LY573636 is administered intravenously every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.
12013697|NCT00490425|Drug|Lactobacillus rhamnosus strain GG ATCC 53103 (LGG, 1010 cfu)|
12013698|NCT00490412|Dietary Supplement|Vitamin D supplement|Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
12013699|NCT00490412|Other|Placebo|A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
12013700|NCT00490399|Drug|gemcitabine|
12013701|NCT00490399|Drug|cisplatin|
12013702|NCT00490373|Drug|pemetrexed|
12013703|NCT00490360|Drug|Gemcitabine / Cisplatin|
12013704|NCT00490347|Device|VentrAssist Left Ventricular Assist Device|
12013705|NCT00490321|Device|VentrAssistTM Left Ventricular Assist Device|
12013706|NCT00490308|Drug|Treatment with estradiol valerate|
12013707|NCT00490282|Radiation|Intensity Modulated Radiation Therapy|IMRT Treatment Over 6-7 Weeks
12013708|NCT00490282|Radiation|Adaptive Radiotherapy|ART Treatment Over 6-7 Weeks
12013709|NCT00490269|Drug|Placebo|
12013710|NCT00490269|Drug|Dronabinol|
12013711|NCT00490256|Procedure|Modified Selective Cerebral Perfusion|Modified Selective perfusion is a cardiopulmonary bypass circuit that has been modified to allow blood flow to the lower body as well as the upper body while the surgery is being performed.
12013712|NCT00490243|Drug|budesonide and montelukast|
12013713|NCT00490243|Drug|budesonide and formoterol|
12013714|NCT00490243|Drug|montelukast|
12013715|NCT00490243|Drug|budesonide|
12013716|NCT00490243|Drug|placebo|
12013717|NCT00490230|Drug|WR 279396|
12013718|NCT00490204|Drug|Cetirizine|
12013719|NCT00490191|Drug|Somatropin|
12013720|NCT00490178|Drug|Fenofibrate 80 mg and metformin 1000 mg (fixed combination)|
12013721|NCT00490152|Behavioral|Automated diary system|"Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with Juliana to discuss the product and the technology used in the study. They will also have the opportunity to send emails to Juliana during the course of the study."
12013722|NCT00490152|Behavioral|Automated diary system|"Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with Juliana to discuss the product and the technology used in the study. They will also have the opportunity to send emails to Juliana during the course of the study."
12013723|NCT00490152|Behavioral|Automated diary system|"Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with Juliana to discuss the product and the technology used in the study. They will also have the opportunity to send emails to Juliana during the course of the study."
12013724|NCT00490139|Drug|Lapatinib|Small molecule inhibitor
12013725|NCT00490139|Biological|Trastuzumab|Antibody
12013726|NCT00490126|Other|Laparoscopic Surgery Data Collection|Prospectively and retrospectively collect data on patients who had laparoscopic surgery since January 1, 1990 forward. Data from the initial patient visit note, consultation notes, operative report, discharge summary, and follow-up progress notes will be entered into the database.
12013906|NCT00488826|Biological|Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)|
12013907|NCT00488813|Drug|Third generation cephalosporins|
12013727|NCT00490113|Drug|Pyridoxamine|Two 250 mg capsules, or placebo, given twice a day for four, 4 week periods. Subjects with primary hyperoxaluria will aslo receive escalated doses up to 3500 mg/day for up to 6 1/2 days.
12013728|NCT00490100|Drug|Increlex|
12013729|NCT00490087|Device|Levonorgestrel intrauterine device (IUD)|
12013730|NCT00490074|Biological|DNA-C|1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM
12013731|NCT00490074|Biological|NYVAC-C|NYVAC-C 1 ml IM
12013732|NCT00490061|Drug|Lapatinib|1500 mg po daily orally
12013733|NCT00490061|Procedure|Radiotherapy (radiation)|Standard of Care
12013734|NCT00490061|Device|G.E. Healthcare 1.5T MR, systems revision 12.0 M5|Standard of Care, used to deliver IMRT
12013735|NCT00490061|Device|DCE-MRI|A subset of patients received imaging before and after Lapatinib loading, prior to starting radiotherapy.
12013736|NCT00490048|Procedure|Induced sputum (inhalation of 3.5% saline)|
12013737|NCT00490035|Other|Placebo|Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period
12013738|NCT00490035|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period
12013739|NCT00490035|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.
12013740|NCT00490035|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.
12013741|NCT00490022|Drug|Dihydrotestosterone (DHT) gel (0.7%)|DHT gel, 70 mg/day for one month
12013742|NCT00490022|Drug|Placebo gel|Placebo gel for one month
12013743|NCT00490009|Drug|Bexxar|"Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells.
~Bexxar will be administered to provide the following patient-specific radiotherapy:
~Platelet count of 150,000/mm³ = 75 cGy
~Platelet count ≥ 100,000/mm³ but < 150,000/mm³ = 65 cGy"
12013744|NCT00490009|Drug|Acetaminophen|As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain
12013745|NCT00490009|Drug|Diphenhydramine|As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions
12013746|NCT00490009|Drug|Potassium Iodide (KI)|Administered to prevent thyroid blockage 130 mg orally 3 times a day,
12013747|NCT00489996|Drug|gemcitabine|
12013748|NCT00489996|Drug|cisplatin|
12013749|NCT00489983|Drug|pemetrexed|
12013750|NCT00489983|Drug|gemcitabine|
12013751|NCT00489970|Procedure|Taking of blood samples|No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.
12013752|NCT00489970|Biological|Boostrix|A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
12013753|NCT00489970|Biological|Adacel|A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.
12013754|NCT00489944|Drug|cisplatin|
12013755|NCT00489944|Drug|sunitinib malate|
12013756|NCT00489944|Drug|tamoxifen citrate|
12013757|NCT00489944|Procedure|adjuvant therapy|
12013758|NCT00489931|Drug|VRC-AVIDNA036-00-VP|
12013759|NCT00489918|Drug|teriparatide|Macroflux® patch applied to the abdomen for 30 minutes daily
12013760|NCT00489918|Drug|teriparatide|FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
12013761|NCT00489905|Drug|Zolderonic acid (Zometa)|
12013762|NCT00489892|Drug|Modafinil|
12013763|NCT00489879|Device|Mobile Health Care System (DrUB)|
12013764|NCT00489866|Drug|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
12013765|NCT00489866|Drug|Placebo|Same as active drug.
12013766|NCT00489853|Drug|budesonide/formoterol Turbuhaler 320/9µg|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
12013767|NCT00489853|Drug|formoterol Turbuhaler 9µg|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
12013768|NCT00489853|Other|Placebo|Placebo, 1 inhalation twice daily
12013769|NCT00489840|Drug|Anecortave Acetate Sterile suspension 15 mg|anecortave acetate sterile suspension 15 mg., juxtascleral injection, every 6 months. for 24 months
12013770|NCT00489840|Drug|Anecortave Acetate|anecortave acetate suspension 15 mg. juxtascleral injection every 6 months for 24 months.
12013771|NCT00489827|Drug|Intravenous infusion of saline|Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
12013772|NCT00489827|Other|Intravenous glutamate infusion|Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
12013773|NCT00489814|Behavioral|Questionnaire|Questionnaires administered within 3 weeks before the beginning of the radiation treatment course, twice during radiation therapy, and upon completion of radiation therapy.
12013774|NCT00489801|Other|Exercise|Exercise intervention and lifestyle counseling at centre or exercise intervention at home
12013775|NCT00489775|Drug|Duloxetine|
12013776|NCT00489775|Drug|Paroxetine|
12013777|NCT00489762|Procedure|Installation of an energy efficient heater|
12013778|NCT00489749|Procedure|Protected early weightbearing/Achilles tendon surgery|
12013779|NCT00489736|Drug|dronedarone (SR33589)|oral administration
12013780|NCT00489736|Drug|amiodarone|oral administration
12013781|NCT00489723|Drug|tamsulosin 0.4mg|
12013782|NCT00489710|Drug|talabostat mesylate|
12013783|NCT00489710|Procedure|diagnostic procedure|
12013784|NCT00489710|Procedure|enzyme inhibitor therapy|
12013785|NCT00489710|Procedure|flow cytometry|
12013786|NCT00489710|Procedure|laboratory biomarker analysis|
12013788|NCT00489697|Device|real-time contrast-enhanced ultrasound imaging (CEUS)|Real time contrast enhanced sonography was performed using an ultrasound dedicated system after bolus injection of 1.2 and 2x2.4 ml Sonovue ® (Bracco, Milan, Italy)
12013789|NCT00489658|Drug|Eflornithine plus Nifurtimox combination therapy|
12013790|NCT00489645|Drug|placebo|placebo SC during euglycemia
12013791|NCT00489645|Drug|pramlintide|pramlintide SC during eglycemia
12013792|NCT00489645|Drug|placebo|placebo during hyperglycemia
12013793|NCT00489645|Drug|pramlintide|pramlintide SC during hyperglycemia
12013794|NCT00489632|Behavioral|Questionnaire|Questionnaires administered to pediatric patients and their parent(s) or caregiver(s).
12013795|NCT00489606|Drug|SK3530|
12013796|NCT00489593|Drug|Olanzapine|2.5 mg by mouth (PO) Daily x 28 days, increasing about every 3-14 days in increments of 2.5-5 mg until the designated dose for that cohort is reached.
12013797|NCT00489580|Device|SaeboFlex Dynamic Hand Orthosis|
12013798|NCT00489580|Procedure|Saebo F.T.M. Arm Training Program|
12013799|NCT00489567|Procedure|Blood sample collection|
12013800|NCT00489554|Biological|Synflorix|Intramuscular injection, 3 doses.
12013801|NCT00489554|Biological|Infanrix hexa|Intramuscular injection, 3 doses.
12013802|NCT00489554|Biological|Rotarix|Oral, 2 doses.
12013803|NCT00489541|Device|Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation|TAXUS Element stent implantation
12013804|NCT00489528|Drug|Somatropin; Recombinant human growth hormone (r hGH)|
12013805|NCT00489502|Behavioral|Brief Counseling|
12013806|NCT00489502|Device|REE Assessment|
12013807|NCT00489489|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
12013808|NCT00489489|Drug|Placebo (for Teriflunomide)|"Film-coated tablet
~Oral administration"
12013809|NCT00489489|Drug|Interferon-β|Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
12013810|NCT00489476|Drug|Staccato Loxapine|
12013811|NCT00489476|Drug|Staccato Placebo|Placebo aerosol inhalation (0mg)
12013812|NCT00489463|Device|intra-uterine device (TCu 380A)|
12013813|NCT00489450|Drug|SK3530|
12013814|NCT00489437|Device|ID-PaGIA Heparin/PF4 antibody test|All patients have a 4T's Score completed, a same-day PaGIA performed and a Serotonin Release Assay performed.
12013815|NCT00489437|Procedure|Clinical Prediction Score-HIT Score Card|"clinical prediction rule
~rapid immunoassay"
12013816|NCT00489424|Drug|Placebo|
12013817|NCT00489424|Drug|Acetaminophen|
12013818|NCT00489424|Drug|Fluvastatin|
12013819|NCT00489411|Drug|duloxetine hydrochloride|Given orally
12013820|NCT00489411|Other|placebo|Given orally
12013821|NCT00489398|Drug|epinastine HCL and olopatadine HCL|
12013822|NCT00489385|Drug|Albinterferon|
12013823|NCT00489385|Drug|Ribavirin|
12013824|NCT00489385|Drug|Albuferon|
12013825|NCT00489372|Drug|Se-methyl-seleno-L-cysteine|Given orally
12013826|NCT00489372|Other|placebo|Given orally
12013827|NCT00489372|Other|pharmacological study|Correlative studies
12013828|NCT00489372|Other|laboratory biomarker analysis|Correlative studies
12013829|NCT00489359|Drug|Pemetrexed - Phase 1|500, 600, 700, 800, or 900 milligrams per square meter (mg/m^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)
12013830|NCT00489359|Drug|Carboplatin - Phase 1|area under the concentration time curve (AUC) 5 or 6 mg/mL*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)
12013831|NCT00489359|Drug|Pemetrexed - Phase 2|Dose determined from Phase 1: 500 mg/m^2, administered IV, every 21 days x 6 cycles
12013832|NCT00489359|Drug|Carboplatin - Phase 2|Dose determined from Phase 1: AUC 6 mg/mL*min, administered IV, every 21 days x 6 cycles
12013833|NCT00489346|Drug|MK0476, montelukast sodium / Duration of Treatment: 1 Year|
12013834|NCT00489346|Drug|Comparator : fluticasone propionate / Duration of Treatment: 1 Year|
12013835|NCT00489333|Drug|ProAlgaZyme|
12013836|NCT00489320|Device|Cypher Stent|
12013837|NCT00489307|Drug|Dexamethasone|4 mg PO (by mouth) twice daily x 14 days
12013838|NCT00489307|Drug|Placebo|Placebo PO twice daily x 14 days
12013839|NCT00489294|Drug|Syntropin|
12013840|NCT00489281|Drug|Cyclophosphamide|Cyclophosphamide (Cy) 14.5 mg/kg/day intravenously (IV) on Days -6 and -5 and 50 mg/kg/day IV on Days +3 and +4.
12013841|NCT00489281|Drug|Fludarabine|Fludarabine 30 mg/m^2/day IV on Days -6, -5, -4, -3, and -2.
12013842|NCT00489281|Drug|Mycophenolate mofetil|Mycophenolate mofetil 15 mg/kg by mouth (PO) three times a day from Day +5 to Day +35.
12013843|NCT00489281|Drug|Sirolimus|The first dose of Sirolimus is 6 mg PO on Day +5. Further dosing is adjusted according to drug levels. Sirolimus is continued through Day +365.
12013844|NCT00489281|Procedure|Allogeneic bone marrow transplant|An allogeneic bone marrow transplant is a procedure that involves taking bone marrow from a donor and giving it to a recipient.
12013845|NCT00489281|Radiation|Total body irradiation - 200|200 centigray (cGy) in one fraction on Day -1.
12013846|NCT00489281|Drug|Levetiracetam|Given at 500 mg PO twice daily from Day -6 to Day +365.
12013847|NCT00489281|Biological|Anti-thymocyte globulin|Test dose of 0.5 mg/kg IV given on Day -9, then 2 mg/kg/day IV on Day -8 and -7.
12013848|NCT00489281|Radiation|Total body irradiation - 400|400 centigray (cGy) in one fraction on Day -1.
12013849|NCT00489268|Device|HALO Ablation System|"Phase I: 1-2 ablation visits; Phase II 1 to 12 months: 1-2 ablation visits; Phase II 12 to 30 months: 1-3 ablation visits Phase II 55-60 months: 0-1 ablation visit
~******Phase I was a dosimetry study and Phase II used the preferred dose. The same intervention was used for each dose."
12013850|NCT00489255|Drug|Tigan®|Oral capsule, 300mg three times daily
12013851|NCT00489255|Drug|Placebo|Oral capsule, three times daily
12013852|NCT00489242|Procedure|Procedure / Percutaneous angioplasty|
12013853|NCT00489229|Drug|Rosiglitazone|
12013854|NCT00489229|Drug|Ramipril|
12013908|NCT00488800|Biological|pneumococcal conjugate vaccine|
12013909|NCT00488787|Drug|intranasal ketamine|low dose
12013855|NCT00489216|Biological|efalizumab|"Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
~1mg/kg"
12013856|NCT00489203|Drug|beclomethasone dipropionate|Given orally
12013857|NCT00489203|Drug|placebo|Given orally
12013858|NCT00489203|Drug|tacrolimus|Given after transplant
12013859|NCT00489203|Drug|methotrexate|Given after transplant
12013860|NCT00489203|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo stem cell transplant
12013861|NCT00489190|Drug|Insulin Glulisine|
12013862|NCT00489177|Device|A|QuickOpt intra-cardiac electrogram optimization
12013863|NCT00489177|Device|B|Single optimization in initial month post-implant
12013864|NCT00489164|Device|Sirolimus-Eluting BX Velocity Balloon-Expandable Stent|
12013865|NCT00489151|Drug|adefovir dipivoxil|
12013866|NCT00489151|Drug|lamivudine|
12013867|NCT00489138|Drug|Ertapenem|1g a day by drip of 30 min
12013868|NCT00489125|Other|physiologic testing|physical testing of range of motion, grip strength etc.
12013869|NCT00489112|Drug|Alfuzocine XL 10 mg once a day|
12013870|NCT00489099|Biological|V232 Modified Process Hepatitis B Vaccine: Lot A|
12013871|NCT00489099|Biological|V232 Modified Process Hepatitis B Vaccine: Lot B|
12013872|NCT00489099|Biological|V232 Modified Process Hepatitis B Vaccine: Lot C|
12013873|NCT00489099|Biological|V232 Current Process Hepatitis B Vaccine|
12013874|NCT00489086|Drug|tazarotene|Tazarotene is a member of the acetylenic class of retinoids.
12013875|NCT00489073|Drug|duloxetine|
12013876|NCT00489073|Drug|placebo|
12013877|NCT00489060|Procedure|Cryoablation and External Beam Radiation|
12013878|NCT00489034|Behavioral|Quantitative Interview|Index participants will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for 18 months while network members will be interviewed at baseline and one year. Interviews will consist of in-depth face-to-face and audio computer-assisted interviews (ACASIs) and a structured diagnostic interview to assess engagement in care (number of clinical visits attended), substance use, attitudes about substance use, friend's substance use, sexual risk behaviors, PTSD (for index participants only), support of index participants care use (network participants only), attitudes about healthcare (network participants only), index participant's adherence (network participants only), own functioning (network participants only), and family functioning (network participants only). At Baseline only, a urine sample will be collected from index participants for drug testing to assess the agreement between urine and ACASI.
12013879|NCT00489034|Behavioral|Ethnographic Interview|Qualitative interviews will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of 18 months. Interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and guide their progression.
12013880|NCT00489034|Behavioral|Gender Interview|Qualitative interviews will be conducted with a sub-sample of index participants. These interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey.
12013881|NCT00489021|Procedure|sub-acute hospitalization|
12013882|NCT00489008|Procedure|Stereotactic Body Radiation Therapy (SBRT)|"Cohorts 1 & 2: 50 gray (GY) with 12.5 GY per Fraction for 4 treatments
~Cohort 3: 40 GY with 10 GY per Fraction for 4 treatments"
12013883|NCT00488995|Drug|CP-675,206|
12013884|NCT00488982|Drug|Docetaxel|Docetaxel 75mg/m2 every 21 days
12013885|NCT00488982|Drug|Docetaxel and GM-CSF|Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28
12013886|NCT00488969|Drug|Modified-release morphine|During the first three weeks of each treatment (drug or placebo), the dose will be escalated toward a maximally tolerated dose or a dose sufficient to eliminate pain (up to a ceiling dose of 120 mg), whichever is reached first. During the entire fourth and fifth week of each period, subjects will receive their maximally tolerated dose of study medication. During the sixth and seventh weeks, they will undergo a seven-day dose tapering and a seven-day complete washout of the study drug.
12013887|NCT00488969|Drug|Placebo|
12013888|NCT00488943|Device|AAA Endovascular Bifurcated Stent-Graft|Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft.
12013889|NCT00488930|Other|Observational|data collection ONLY
12013890|NCT00488904|Dietary Supplement|supportan|2 sip feed pr. day
12013891|NCT00488904|Dietary Supplement|supportan placebo|2 sip feed pr. day
12013892|NCT00488891|Drug|Paliperidone ER|Route = oral. Paliperidone ER will be prescribed to the patients at the investigator's discretion. Patient receive their medication according to usual care in their treatment setting ie, no study drug is provided
12013893|NCT00488891|Drug|Atypical antipsychotics (AAP)|Route = oral. AAP including quetiapine, risperidone, olanzapine, ziprasidone or aripiprazole. Dosage and administration of antipsychotics will be prescribed at the investigator's discretion
12013894|NCT00488878|Behavioral|Data Collection|Data collection from ovarian cancer patients seen at M.D. Anderson since January, 1950.
12013895|NCT00488865|Device|Intravascular Filter Device|Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.
12013896|NCT00488839|Drug|IPX056 20 mg|IPX056 Extended Release capsule containing 20 mg baclofen
12013897|NCT00488839|Drug|IPX056 40 mg|IPX056 Extended Release capsule containing 40 mg baclofen
12013898|NCT00488839|Drug|Encapsulated Baclofen 20 mg|Baclofen 20mg tablet was encapsulated for blinding.
12013899|NCT00488839|Drug|Placebo Baclofen Tablet|Placebo capsule encapsulated placebo Baclofen tablet
12013900|NCT00488839|Drug|IPX056 10 mg|IPX056 Extended Release capsule containing 10 mg baclofen
12013901|NCT00488839|Drug|IPX056 30 mg|IPX056 Extended Release capsule containing 30 mg baclofen
12013902|NCT00488839|Drug|IPX056 35 mg|IPX056 Extended Release capsule containing 35 mg baclofen
12013903|NCT00488839|Drug|Placebo IPX056 20 mg|Placebo capsule for IPX056 20 mg
12013904|NCT00488839|Drug|Placebo IPX056 40 mg|Placebo capsule for IPX056 40 mg
12013905|NCT00488826|Biological|7-valent pneumococcal conjugate vaccine|
12013910|NCT00488787|Drug|intranasal ketamine|medium dose
12013911|NCT00488787|Drug|intranasal ketamine|high dose
12013912|NCT00488787|Drug|placebo|placebo
12013913|NCT00488774|Other|Placebo|Matching placebo for golimumab, intravenous infusion administered at Week 0
12013914|NCT00488774|Drug|Golimumab 1 mg per kg|Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
12013915|NCT00488774|Drug|Golimumab 2 mg per kg|Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
12013916|NCT00488774|Drug|Golimumab 4 mg per kg|Golimumab 4 mg per kg intravenous (IV) infusion at Week 0
12013917|NCT00488761|Drug|Tigecycline|
12013918|NCT00488748|Device|Thymatron|Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)
12013919|NCT00488748|Device|Magstim Theta|100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
12013920|NCT00488735|Behavioral|Cognitive-behavioral rehabilitation|
12013921|NCT00488735|Behavioral|Traditional primary care|
12013922|NCT00488722|Drug|Zoladex|
12013923|NCT00488709|Drug|Topotecan|
12013924|NCT00488709|Drug|Fludarabine|
12013925|NCT00488709|Drug|Cytarabine|
12013926|NCT00488696|Device|Endovascular Bifurcated Stent-Graft|Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.
12013927|NCT00488683|Biological|MenACWY-CRM|One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.
12013928|NCT00488683|Biological|DTaP-Hib-IPV|IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.
12013929|NCT00488683|Biological|PCV|IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.
12013930|NCT00488683|Biological|MMR|IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.
12013931|NCT00488683|Biological|Hib|IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.
12013932|NCT00488670|Drug|Escitalopram|See Detailed Description.
12013933|NCT00488657|Device|SpeechEasy Model ITC|The delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz.
12013934|NCT00488644|Drug|Levothyroxine|75 mcg by mouth (PO) Daily for 8 Weeks
12013935|NCT00488644|Drug|Liothyronine|15 mcg PO Daily for 8 Weeks
12013936|NCT00488631|Biological|Placebo|Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
12013937|NCT00488631|Biological|Golimumab 50 mg|Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
12013938|NCT00488631|Biological|Golimumab 100 mg|Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
12013939|NCT00488631|Biological|Golimumab 200 mg|Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
12013940|NCT00488618|Drug|Cariprazine (RGH-188)|Cariprazine 3 mg - 12 mg oral administration, once per day.
12013941|NCT00488618|Drug|Placebo|Dose-matched placebo oral administration, once per day.
12013942|NCT00488605|Drug|Prednisone, Vinblastin, 6-mercaptopuroine|Initial Therapy:Prednisone- by mouth 3 times/day daily as a 4-week course, then gradually decreased over 2 more weeks. Vinblastine-IV (into a vein)1 day/week for 6 weeks. Patients w/o evidence of active disease at this time will proceed to continuation therapy. If disease is improved or unchanged, pts. will receive additional therapy with: Prednisone- 3 divided doses by mouth for 3 days every week, from week 7-12. Vinblastine- IV 1day/week for 6 more weeks. If the disease is gone or better after this additional therapy continuation will begin. Continuation Therapy: 6-MP:by mouth daily until the end of month 12. Prednisone in 3 doses daily day 1-5 every 3 weeks until the end of month 12. Vinblastine IV day 1 every 3 weeks until the end of month 12.
12013943|NCT00488605|Drug|Leucovorin, Methotrexate, Vinblastine, Prednisone|Initial Therapy:Prednisone-by mouth 3x/day daily as a 4-week course then gradually decreased over 2 more weeks. Vinblastine- IV 1 day/week for 6 weeks. Methotrexate-a 24 hour IV infusion day 1 of weeks 1, 3, and 5, followed by leucovorin.The drug will be given by mouth. Pts w/o evidence of active disease at this time will proceed to continuation therapy. Pts whose disease is improved or unchanged will receive additional therapy w/:Prednisone- 3 divided doses, days 1-3 weekly from week 7-12. Vinblastine IV 1day/week for 6 more weeks. Methotrexate-a 24 hour IV infusion day 1 of week 7, 9, and 11, followed by leucovorin. If the disease is gone or better after this additional therapy continuation will begin. Continuation Therapy: 6-MP by mouth daily until the end of month 12. Prednisone- 3 doses daily days 1-5 every 3 weeks until the end of month 12. Vinblastine IV day 1 every 3 weeks until the end of month 12. Methotrexate by mouth once weekly until the end of month 12.
12013944|NCT00488592|Biological|WT1:126-134|"Subjects were given 6 doses of PR1:169-177 in Montanide adjuvant and 6 doses of WT1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals."
12013981|NCT00488215|Drug|prucalopride|The dose will be consecutively escalated in 2 mg steps per day, starting from 2 mg up to 20 mg once daily or until severe drug-related adverse events occur (= individual maximum tolerable dose, on decision of the subject and/or investigator).
12013982|NCT00488215|Other|Placebo|During the placebo session, the number of placebo tablets will be consecutively escalated in an identical way as described for prucalopride. This means 1 tablet more every day, up to 10 tablets.
12013945|NCT00488592|Biological|PR1:169-177 Peptide|Subjects were given 6 doses of PR1:169-177 in montanide adjuvant and 6 doses of WT-1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.
12013946|NCT00488592|Drug|GM-CSF (Sargramostim)|Subjects were given 6 doses of PR1:169-177 in montanide adjuvant and 6 doses of WT-1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.
12013947|NCT00488592|Biological|Montanide adjuvant|Subjects were given 6 doses of PR1:169-177 in montanide adjuvant and 6 doses of WT-1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.
12013948|NCT00488579|Drug|Two policies of iron prophylaxis|60mg ferrous sulphate daily (+folic acid); Screening and therapy: Hb measurement on each visit, Hb>9g/dl only folic acid, Hb<9g/dl 60-120 of ferrous sulphate daily (+folic acid).
12013949|NCT00488566|Drug|GSK drug|GSK drug
12013950|NCT00488566|Other|Placebo|Placebo
12013951|NCT00488566|Other|Lamictal|Positive control
12013952|NCT00488553|Behavioral|Questionnaire|Questions about cancer risk factors, medical history, and family history of cancer.
12013953|NCT00488540|Drug|Paracetamol|Suppository
12013954|NCT00488540|Drug|Placebos|Suppository
12013955|NCT00488527|Drug|Insulin glargine|Patients will begin with a fixed, subcutaneous dose of insulin glargine, (10 U), in its commercial presentation, which will be adjusted week by week, according to the values of the glycemia when fasting (FBG), adding 2, 4, 6 or 8 units of insulin glargine over the following twelve weeks, during which the therapeutic objective should be attained, namely the glucose goal during fasting of 100 mg/dl (<6.0 mmol/L), and the active treatment is to be continued for three more months.
12013956|NCT00488514|Drug|Combination Tablet of Treximet (sumatriptan/naproxen sodium)|Combination Tablet of Treximet(sumatriptan/naproxen sodium)
12013957|NCT00488488|Drug|tigecycline|The patients will be treated in accordance with the requirements of the labeling of tigecycline in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
12013958|NCT00488475|Drug|etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
12013959|NCT00488462|Device|non-pneumatic anti-shock garment|In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria.
12013960|NCT00488449|Drug|GSK256073A tablets|
12013961|NCT00488436|Drug|Antithymocyte globulin|
12013962|NCT00488436|Drug|Cyclosporine|
12013963|NCT00488423|Procedure|Mixed Meal Tolerance test, Hyperglycemic clamp|Subjects undergo a standard mixed meal tolerance test & hyperglycemic clamp to assess insulin secretion & sensitivity (whole body glucose disposal) pre-op. Following surgery, at 1week, 1 month, 6 months and 12 months subjects will undergo hyperglycemic clamp & mixed meal tolerance test. During these tests, measurements will include plasma levels of glucose, insulin, C-peptide, free fatty acid levels and adipocyte hormone profile (adiponectin, leptin, resistin). A gut hormone profile (ghrelin, glucagons-like-peptide 1 GLP-1, glucose-dependent insulinotropic polypeptide GIP, PYY) will be performed at fasting & specific postprandial times. Results will be compared between two groups: patients undergoing laparoscopic Roux-en-Y gastric bypass & gastric banding.
12013964|NCT00488410|Device|Doppler echocardiography|
12013965|NCT00488397|Other|In-vitro testing|This is an in-vitro study thus only one group in the study and there is no intervention treatment nor procedure involved in this study.
12013966|NCT00488384|Drug|Chemopreventive application (Acitretin)|Chemopreventive application (Acitretin)
12013967|NCT00488371|Biological|Pneumococcal Conjugated Vaccine (Prevnar®)|
12013968|NCT00488345|Drug|Tygacil|
12013969|NCT00488332|Procedure|Optical Coherence Tomography|Before radiation treatment and once a week thereafter.
12013970|NCT00488332|Procedure|Fluorescence Spectroscopy|Before radiation treatment and once a week thereafter.
12013971|NCT00488332|Behavioral|Pain Scale Questionnaire|Administered before the examination, OCT, and FS and immediately afterward.
12013972|NCT00488319|Drug|Paliperidone ER|1.5 to 12 mg tablet once daily for 6 months
12013973|NCT00488306|Drug|tigecycline|
12013974|NCT00488293|Procedure|Store and forward teledermatology|Standard electronic consult, standardized history, and image set
12013975|NCT00488280|Behavioral|Locomotor Training|Task-specific practice of walking with assistance from trainers using body weight support and treadmill followed by training over ground, 5x/week, approximately 1.5 hours/day
12013976|NCT00488267|Drug|ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)|Transdermal patch applied to the knee for 12 hours daily.
12013977|NCT00488267|Drug|Placebo Matrix/CHADD Patch|Transdermal patch applied to the knee for 12 hours daily.
12013978|NCT00488267|Drug|Ketoprofen matrix/placebo CHADD Patch|Transdermal knee applied to the knee for 12 hours daily.
12013979|NCT00488241|Device|Zarzenda|Topically applied daily for 2 weeks
12013980|NCT00488228|Behavioral|self-regulation|The current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing.
12014196|NCT00486512|Drug|placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)|
12013983|NCT00488189|Drug|Tazocin (pipercillin/tazobactam)|over 50% third generation cephalosporin should be replaced by Pip/Taz
12013984|NCT00488176|Drug|montelukast|montelukast sodium
12013985|NCT00488176|Drug|cetirizine|cetirizine
12013986|NCT00488176|Drug|montelukast and cetirizine|montelukast and cetirizine
12013987|NCT00488176|Drug|placebo|placebo
12013988|NCT00488163|Drug|Atomoxetine|Dose escalation from 40 mg to 50 mg of Atomoxetine active treatment.
12013989|NCT00488137|Drug|Prucalopride|2 mg o.d.
12013990|NCT00488137|Other|Placebo|o.d.
12013991|NCT00488137|Drug|Prucalopride|4 mg o.d.
12013992|NCT00488124|Drug|somatropin (Genotropin® treatment)|0,035 mg /kg bodyweight of Somatropin per day given by subcutaneous injections through an injection device (GenotropinPEN)
12013993|NCT00488111|Other|Ringer's Lactate|Ringer's Lactate was used 15min before operation
12013994|NCT00488111|Other|6% Starch|6% Starch was used 15min before operation
12013995|NCT00488098|Drug|GSK372475|
12013996|NCT00488072|Drug|Mirtazapine|15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.
12013997|NCT00488072|Drug|Placebo|One placebo tablet by mouth daily.
12013998|NCT00488059|Drug|enfuvirtide [Fuzeon]|90 mg SC twice daily
12013999|NCT00488059|Drug|Optimized background ARV|As prescribed
12014000|NCT00488059|Drug|Integrase inhibitor|As prescribed
12014001|NCT00488059|Drug|enfuvirtide [Fuzeon]|180 mg SC once daily
12014002|NCT00488046|Biological|H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)|Intranasal vaccine
12014003|NCT00488033|Procedure|CT Angiography|If results indicate blockage, patients will receive interventional assessment (i.e., angiography) and treatment if indicated. All patients will receive aggressive treatment for type II diabetes (hemoglobin A1C) and lipids.
12014004|NCT00488020|Procedure|stem cells transplant|
12014005|NCT00488007|Device|Hearing aids used : PHONAK Savia and Valeo|5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)
12014006|NCT00487994|Drug|Lapaquistat acetate|Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin placebo-matching capsules, orally, once daily for up to 96 weeks.
12014007|NCT00487994|Drug|Lapaquistat acetate and atorvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks.
12014008|NCT00487994|Drug|Atorvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks.
12014009|NCT00487981|Device|Precision Spinal Cord Stimulation|Stimulation on throughout the study once device is implanted
12014010|NCT00487968|Drug|eltrombopag|
12014011|NCT00487955|Procedure|Resting Energy Expenditure examination|
12014012|NCT00487942|Drug|armodafinil|50 mg/day armodafinil
12014013|NCT00487942|Drug|armodafinil|100 mg/day armodafinil
12014014|NCT00487942|Drug|armodafinil|200 mg/day armodafinil
12014015|NCT00487942|Drug|placebo|placebo
12014016|NCT00487929|Device|nasal CPAP|Nocturnal
12014017|NCT00487929|Device|Sham CPAP|Nocturnal
12014018|NCT00487916|Drug|AMA1-C1/ISA 720|
12014019|NCT00487903|Drug|PB127 for Injectable Suspension|0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.
12014020|NCT00487877|Device|SenseWear Pro3 Armband|
12014021|NCT00487877|Device|i-button DS2191 H|
12014022|NCT00487851|Procedure|surgery|hepaticojejunostomy and gastroenterostomy
12014023|NCT00487851|Procedure|endoscopic strategy|Stent insertion
12014024|NCT00487825|Drug|Canakinumab (investigational)|Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
12014025|NCT00487825|Drug|Placebo|Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
12014026|NCT00487825|Drug|Methotrexate (MTX)|Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.
12014027|NCT00487812|Procedure|Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging|All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)
12014028|NCT00487799|Drug|Ularitide|
12014029|NCT00487786|Drug|OGX-427|OGX-427 injection at 200mg, 400mg, 600mg, 800mg or 1000mg once a week until withdrawn
12014030|NCT00487786|Drug|Docetaxel|injection - 75 mg/M2 IV on Day 1 every 21 days for cohorts 6 & 7 only, together with appropriate dose of OGX-427 until withdrawn from study
12014031|NCT00487773|Drug|budesonide|budesonide
12014032|NCT00487773|Drug|D3 vitamin|D3 vitamin
12014033|NCT00487773|Drug|montelukast sodium|montelukast sodium
12014034|NCT00487773|Drug|salbutamol|salbutamol
12014035|NCT00487747|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 48 weeks
12014036|NCT00487734|Radiation|Testosterone gel|testosterone gel, applied daily. Dosed to achieve testosterone level <500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.
12014037|NCT00487734|Drug|Placebo for testosterone gel|Placebo gel, 2.5g for each gel packet
12014038|NCT00487721|Drug|Silibin-Phytosome|Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose.
12014039|NCT00487708|Drug|canakinumab|
12014040|NCT00487695|Device|confocal laser endomicroscopy (CLE)|Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.
12014041|NCT00487695|Device|standard endoscopy (EGD)|Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
12014042|NCT00487682|Drug|ASP2151|oral
12014043|NCT00487682|Drug|Valacyclovir hydrochloride|oral
12014197|NCT00486512|Procedure|Colonoscopy|
12014044|NCT00487669|Drug|paclitaxel poliglumex, pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued
12014045|NCT00487656|Drug|ART-123|6mg/ml ampule solution for injection @ .01mg/kg
12014046|NCT00487656|Drug|placebo|6 mg/ml ampule solution for injection at .01mg/kg
12014047|NCT00487643|Procedure|Tear Collection|The tear sample will be collected from the left eye of each subject. Subjects wearing contact lenses will be instructed to remove their lenses and wait at least 5 minutes before proceeding with the tear collection procedure. The patient will then be instructed to sit with eyes gently closed for two minutes after instilling one (1) drop of 0.5% proparacaine on the cornea and conjunctiva. Tear collection was accomplished by using a polyester fiber rod wick. This wick will be placed in contact with the tear fluid at the lower cul-de-sac for a minimum time to obtain fluid without irritating the subject's eye approx. for 3 to 5 minutes.
12014048|NCT00487630|Drug|recombinant alpha-galactosidase A|
12014049|NCT00487617|Procedure|Fruit juice or placebo absorption|absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.
12014050|NCT00487591|Drug|Omacor (omega-3-acid ethyl esters)plus simvastatin|Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg)
12014051|NCT00487591|Drug|simvastatin plus placebo|simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo
12014052|NCT00487578|Drug|naratriptan HCl|naratriptan 2.5mg tablet bid x 30 days OR matching placebo
12014053|NCT00487565|Device|Total knee arthroplasty|Total knee arthroplasty using a posterior stabilized implant
12014054|NCT00487552|Device|Cook Magnetic Anastomosis Device (MAD) with Stent|Gastro-jejunal anastomosis
12014055|NCT00487539|Biological|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
12014056|NCT00487539|Biological|Golimumab 100 mg|Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group.
12014057|NCT00487539|Biological|Golimumab 200 mg|Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group.
12014058|NCT00487539|Biological|Golimumab 400 mg|Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -> 200 mg arm group.
12014059|NCT00487539|Biological|Golimumab 50 mg|Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -> 50 mg arm group.
12014060|NCT00487526|Procedure|duodenal jejunal bypass|
12014061|NCT00487513|Procedure|Procurement of Follicular B Cell Lymphoma Cells|Participants will undergo the following procedure(s) that are appropriate for collecting their tissue: Blood collection, lymph node biopsy, drainage of an effusion, or bone marrow biopsy
12014062|NCT00487500|Device|Electroconvulsive Therapy (ECT)|Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
12014063|NCT00487474|Device|DL6049 (injectable poly-L-lactic acid)|Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
12014064|NCT00487461|Drug|Simvastatin 40 mg|Comparing two doses of Simvastatin to placebo
12014065|NCT00487461|Drug|Placebo|Placebo tablet
12014066|NCT00487461|Drug|Simvastatin 80 mg|Comparing two doses of Simvastatin to placebo
12014067|NCT00487448|Drug|Fludarabine|
12014068|NCT00487448|Drug|Cytarabine|
12014069|NCT00487448|Drug|G-CSF|
12014070|NCT00487448|Drug|Idarubicin|
12014071|NCT00487448|Procedure|Peripheral blood stem cell transplantation|
12014072|NCT00487448|Procedure|Bone marrow transplantation|
12014073|NCT00487435|Drug|Tapentadol (CG5503) Extended Release (ER)|100, 150, 200, 250 mg oral tablet twice daily for 52 weeks
12014074|NCT00487422|Drug|prucalopride|2 mg o.d.
12014075|NCT00487422|Drug|Prucalopride|4 mg o.d.
12014076|NCT00487422|Other|Placebo|o.d.
12014077|NCT00487409|Procedure|Bipolar electrosurgical generator and instruments|laparoscopic colectomy using the Ligasure device
12014078|NCT00487409|Procedure|Disposable stapling instruments|laparoscopic colectomy using clips, cautery and stapler
12014079|NCT00487396|Device|Capsule Endoscopy|Pillcam Platform with RAPID5 software and supporting SB2 capsules
12014080|NCT00487370|Procedure|Implantation of gold beads around a knee through needles|
12014081|NCT00487370|Procedure|Sham implantation: Insertion of needles around a knee|
12014082|NCT00487357|Behavioral|Supplemental Survey|Questionnaire give during home visit to collect behavioral, risk factors and other smoking status data on MATCh parents/guardians.
12014083|NCT00487344|Procedure|Non-Personalized Meal Planning|
12014084|NCT00487344|Procedure|Personalized Meal Planning and Dietetic Consultation|
12014085|NCT00487331|Other|Acupuncture|Acupuncture sessions 1-3 times per week.
12014086|NCT00487331|Behavioral|Survey|2 pain questionnaires + satisfaction survey completed at beginning and end of treatment
12014087|NCT00487318|Drug|standard of care|peginterferon/RBV
12014088|NCT00487318|Drug|fluvastatin|Add fluvastatin at 20-40 mg/day to standard of care
12014089|NCT00487305|Biological|Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells|Dose will vary depending upon number of cells collected and when the participant is enrolled on the study: the vaccine is given as an injection under the skin once weekly for 3 weeks then every other week for 3 vaccines.
12014090|NCT00487292|Behavioral|naps and pulses of bright light|
12014091|NCT00487279|Device|Defibrillator|ICD(Implantable Cardioverter Defibrillator)
12014092|NCT00487279|Other|Control|No Intervention
12014093|NCT00487266|Other|Acupuncture|Acupuncture of low back and legs.
12014094|NCT00487253|Drug|Miltefosine|Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
12014198|NCT00486499|Procedure|I-125 versus Pd-103 radioactive seed insertion|
12014095|NCT00487253|Drug|Meglumine antimoniate|Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.
12014096|NCT00487240|Drug|Insulin Lispro Protamine Suspension|Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.
12014097|NCT00487240|Drug|Insulin Levemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
12014098|NCT00487227|Drug|caffeine|
12014099|NCT00487227|Drug|Placebo|
12014100|NCT00487201|Procedure|endoscopic balloon dilatation|
12014101|NCT00487201|Procedure|plastic stent placement|
12014102|NCT00487188|Drug|Enfuvirtide|90 mg subcutaneous injection twice a day
12014103|NCT00487188|Drug|Highly active antiretroviral treatment (HAART)|An oral HAART regimen of 3-5 antiretrovirals was chosen by the physician and patient, based on the patient's prior treatment history and genotypic antiretroviral resistance testing.
12014104|NCT00487175|Drug|Tramadol|to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
12014105|NCT00487162|Procedure|intensive glycemic control|intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
12014106|NCT00487162|Drug|conventional glycemic control|Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
12014107|NCT00487136|Drug|Warfarin|Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
12014108|NCT00487136|Drug|warfarin plus ABT-335 plus rosuvastatin 5 mg|Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
12014109|NCT00487136|Drug|warfarin plus ABT-335 plus rosuvastatin 20 mg|Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
12014110|NCT00487123|Drug|Valsartan+/- Hydrochlorothiazide|
12014111|NCT00487110|Drug|Tropisetron|a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol
12014112|NCT00487110|Drug|paracetamol|a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol
12014113|NCT00487097|Dietary Supplement|Eicosapentanoic acid, docosahexaenoic acid|Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid
12014114|NCT00487084|Drug|Morphine-CP-saline (MCS)|3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision
12014115|NCT00487084|Drug|saline-2CP-morphine (SCM)|6ml of saline will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 3mg of preservative free morphine will be administered at skin incision
12014116|NCT00487084|Drug|saline-lidocaine-morphine (SLM)|3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 2% lidocaine with epinephrine 1:200,000 will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision
12014117|NCT00487071|Device|Anal fistula plug|
12014118|NCT00487058|Drug|Gimatecan|
12014119|NCT00487045|Device|Hem-Avert Perianal Stabilizer|Hem-Avert Perianal Stabilizer, TNP-01L, single-use, disposable, sterile, individually packaged instrument
12014120|NCT00487032|Drug|Oxymetazoline 0.05% w/v|2 squirts in each nostril thrice daily
12014121|NCT00487032|Drug|Fluticasone propionate 50 micrograms per actuation|2 Squirts in each nostril twice daily
12014122|NCT00487032|Drug|Prazosin hydrochloride|Prazosin 1mg one dose only
12014123|NCT00487032|Drug|Placebo to Prazosin|Placebo 1 tablet one dose only
12014124|NCT00487006|Other|Serum Lab testing|Serum Lab testing
12014125|NCT00486993|Behavioral|Dietary and nutritional modification|
12014126|NCT00486993|Behavioral|Stop smoking|
12014127|NCT00486993|Behavioral|Regular physical activities|
12014128|NCT00486993|Behavioral|Weight reduction to normal ranges|
12014129|NCT00486993|Behavioral|Regular intake of polyphenols, esp. from Ilex paraguayensis|
12014130|NCT00486980|Drug|Peramivir 150mg|
12014131|NCT00486980|Drug|Peramivir 300mg|
12014132|NCT00486954|Drug|Lapatinib|6 pills at 250 mg each once daily
12014133|NCT00486954|Drug|Paclitaxel|Infusion at 80 mg/m2 weekly
12014134|NCT00486941|Behavioral|Exercise and diet - based on DPS and DPP|
12014135|NCT00486915|Procedure|Left Atrial Appendage Ligation|
12014136|NCT00486902|Drug|Ketamine|Ketamine 10 mg diluted to 20 mL delivered over 10 minutes via an infusion pump set at 2ml/minute
12014137|NCT00486902|Drug|Placebo|Saline 20 mL IV infusion delivered over 10 minutes via an infusion pump set at 2ml/minute
12014138|NCT00486889|Biological|alglucosidase alfa|Intravenous (IV) infusion: 20mg/kg every 2 weeks
12014139|NCT00486876|Drug|Dextofisopam|capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
12014140|NCT00486863|Drug|Praziquantel|60 mg/kg administered orally given in split dose (30/mg/kg each) separated by 3 hours; over-encapsulated in gelatin capsules. Two capsule sizes will be made which will be differentiated by color; these will contain 300 mg or 150 mg to allow for best dosing by weight.
12014141|NCT00486863|Other|Placebo|Made with the same color coded gelatin capsules with the inert compound dextrose.
12014142|NCT00486850|Other|Extubation to Nasal IPPV|Comparison of extubation to NIPPV versus NCPAP
12014143|NCT00486837|Drug|Alpha1-Proteinase Inhibitor (Human)|25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks.
12014144|NCT00486824|Drug|Indomethacin|One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs.
12014145|NCT00486824|Drug|Nifedipine|Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.
12014146|NCT00486811|Drug|Tapentadol ER (100 to 250 mg twice daily)|50, 100, 150, 200, 250 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
12014272|NCT00485940|Drug|Prucalopride|4 mg o.d.
12014147|NCT00486811|Drug|Matching Placebo (twice daily)|Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance)
12014148|NCT00486811|Drug|Oxycodone CR (20 to 50 mg twice daily)|10, 20, 30, 40, 50 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
12014149|NCT00486798|Drug|Quetiapine|
12014150|NCT00486798|Procedure|Rating Scales|
12014151|NCT00486798|Procedure|Self Assessment Form|
12014152|NCT00486798|Procedure|Blood and urine samples|
12014153|NCT00486798|Procedure|Sleeping pattern|
12014154|NCT00486785|Drug|Alfuzosin|Alfuzosin 10mg Once Daily for 24 weeks
12014155|NCT00486772|Drug|Sevelamer (Renagel), calcium acetate (Phos-ex)|
12014156|NCT00486759|Drug|Bevacizumab|Bevacizumab was administered at a dose of 15 mg/kg IV on Day 1 of each 21-day cycle for 8 cycles or at a dose 10 mg/kg IV on Day 1 of each 14-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
12014157|NCT00486759|Drug|Rituximab|Rituximab was administered at a dose of 375 mg/m^2 IV on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
12014158|NCT00486759|Drug|CHOP|Cyclophosphamide was administered at a dose of 750 mg/m^2 IV on Day 1 of each cycle. Doxorubicin was administered at a dose of 50 mg/m^2 IV on Day 1 of each cycle. Vincristine was administered at a dose of 1.4 mg/m^2 IV (maximum of 2 mg) on Day 1 of each cycle. Prednisone was administered at a dose of 100 mg orally on Days 1-5 of each cycle. All 4 drugs were administered either every 21 days for 8 cycles or every 14 days for 6 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
12014159|NCT00486759|Drug|Placebo|Placebo to bevacizumab was administered on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
12014160|NCT00486746|Behavioral|Lifestyle intervention (physical activity and dietary counseling)|One-year intervention
12014161|NCT00486746|Behavioral|General information on healthy lifestyle habits|A single session
12014162|NCT00486733|Device|DermaGold|The first four follow-up study assessment and data collection points will coincide with scheduled operative interventions on the wound guided by clinical situation and the treating physician's judgment (approximately every 3-4 days). Subsequent follow-up study assessment and data collection points will occur on study days 28 ± 3, 42 ± 3, 60 ± 3, and 90 ± 3.
12014163|NCT00486720|Drug|vorinostat|vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.
12014164|NCT00486720|Drug|vorinostat|vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.
12014165|NCT00486707|Behavioral|Questionnaire|A questionnaire will be completed.
12014166|NCT00486694|Drug|Sulfadoxine-pyrimethamine + artesunate|
12014167|NCT00486694|Drug|Chloroquine|
12014168|NCT00486681|Device|Accu Chek Inform and Cobas IT 1000|period II (warning activated)
12014169|NCT00486668|Drug|doxorubicin|60 mg/m2 IV every 21 days for cycles 1-4
12014170|NCT00486668|Drug|cyclophosphamide|600 mg/m2 IV every 21 days for cycles 1-4
12014171|NCT00486668|Drug|paclitaxel|80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
12014172|NCT00486668|Drug|trastuzumab|First dose: 4 mg/kg IV, subsequent doses: 2 mg/kg IV weekly beginning on day 1 of the first paclitaxel cycle until 1-7 days before surgery
12014173|NCT00486668|Drug|lapatinib|Group 2: 1250 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery. Group 3: 750 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery.
12014174|NCT00486655|Procedure|NOTES-Assisted Cholecystectomy|
12014175|NCT00486642|Drug|Bicalutamide|Given PO
12014176|NCT00486642|Other|Laboratory Biomarker Analysis|Correlative studies
12014177|NCT00486642|Drug|Pazopanib Hydrochloride|Given PO
12014178|NCT00486642|Other|Pharmacological Study|Correlative studies
12014179|NCT00486629|Behavioral|Exercise and dietary education|Exercise and dietary education. Aerobic exercise or walk for 3-5 times/day for 30-45 min/time from 20 weeks to 36 weeks of pregnancy. Dietary education on nutrition for healthy pregnancy through weekly class during pregnancy.
12014180|NCT00486616|Device|electrical impedance tomography|
12014181|NCT00486616|Procedure|double-lumen tube placement|
12014182|NCT00486603|Drug|hydroxychloroquine|see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles
12014183|NCT00486603|Drug|temozolomide|TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)
12014184|NCT00486603|Other|pharmacological study|Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4
12014185|NCT00486603|Radiation|Radiation|Radiation during the first six weeks of treatment Monday-Friday
12014186|NCT00486590|Procedure|Prolact-Plus Human Milk Fortifier|
12014187|NCT00486577|Procedure|significant chronic primary auditory cortex stimulation during the first two weeks|significant chronic primary auditory cortex stimulation during the first two weeks of the follow up than wash out period followed by two weeks of non significant stimulation
12014188|NCT00486577|Procedure|non significant chronic primary auditory cortex stimulation during the first two weeks|non significant stimulation during the first two weeks of the follow up than wash out period followed by two weeks of significant chronic primary auditory cortex stimulation
12014189|NCT00486564|Drug|Nifurtimox|Escalating dose by cohort starting at 20mg/kg/day. PO drug taken TID.
12014190|NCT00486551|Behavioral|Anger control training|
12014191|NCT00486538|Drug|ABT-869|One oral dose daily.
12014192|NCT00486525|Procedure|Yoga Therapy|Patients will undergo yoga therapy
12014193|NCT00486512|Drug|0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)|
12014194|NCT00486512|Drug|75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)|
12014195|NCT00486512|Drug|placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)|
12014273|NCT00485927|Behavioral|stress|
12014199|NCT00486486|Drug|Drug: bimatoprost/timolol fixed combination AM|3-month chronic dosing in the morning
12014200|NCT00486486|Drug|Bimatoprost/timolol fixed combination dosed PM|Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months
12014201|NCT00486473|Drug|Multihance|0.5 Molar at a single dose injection
12014202|NCT00486473|Drug|Magnevist|0.5M at a single dose injection
12014203|NCT00486460|Drug|Gemcitabine|
12014204|NCT00486460|Drug|Curcumin|
12014205|NCT00486460|Drug|Celebrex|
12014206|NCT00486447|Device|64 Channel VCT|cardiac CT angiography exam
12014207|NCT00486434|Drug|SMC021 Oral Calcitonin|0.8mg SMC021 (Oral Calcitoinin) twice daily
12014208|NCT00486434|Drug|SMC021 Placebo|Placebo orally, twice daily
12014209|NCT00486421|Biological|Rituximab|375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
12014210|NCT00486421|Drug|Prednisone|1mg/kg/d PO, taper to off by 8 weeks
12014211|NCT00486408|Biological|MRKAd5 HIV-1 gag/pol/nef|1.5x10^10 Ad vg
12014212|NCT00486395|Device|CPAP|"CPAP administered via Bubble method or Infant Flow Driver"
12014213|NCT00486395|Device|Mechanical ventilation|Volume guarantee strategy
12014214|NCT00486382|Biological|Leish-111f + MPL-SE Adjuvant|
12014215|NCT00486369|Drug|Oral salmon calcitonin|
12014216|NCT00486356|Drug|capecitabine|
12014217|NCT00486356|Drug|carboplatin|
12014218|NCT00486356|Drug|epirubicin hydrochloride|
12014219|NCT00486356|Genetic|microarray analysis|
12014220|NCT00486356|Genetic|polymorphism analysis|
12014221|NCT00486356|Other|pharmacological study|
12014222|NCT00486343|Drug|Zileuton CR|Zileuton CR tablets 2x600mg BID for 24 weeks
12014223|NCT00486343|Drug|Placebo|Placebo tablets 2x600mg BID for 24 weeks
12014224|NCT00486330|Drug|Buprenorphine, Tipranavir and ritonavir|After determining buprenorphine/naloxone pharmacokinetics over a 24-hour period, tipranavir/ritonavir and buprenorphine/naloxone will be coadministered for 7 days.
12014225|NCT00486317|Drug|Oral salmon calcitonin, salmon calcitonin nasal spray|
12014226|NCT00486304|Other|ADD|The ADD has a composition of 65% carbohydrate, 20% fat, and 15% protein. The diet will be completely depleted of vitamins A, E and beta-carotene; it will have 10 mg of vitamin C (6.5% of RDA) added per person per day
12014227|NCT00486304|Other|Placebo|Jevity 1.5 (1.5 cal/mL) will be used for the placebo patients in this study. This will simulate the standard of care for patients not on the ADD. Jevity 1.5 is an isotonic, fiber-fortified, high-nitrogen liquid formula providing complete, balanced nutrition for patients requiring short- or long-term tube feeding, given once per day
12014228|NCT00486291|Drug|VI-0521|phentermine 15mg/topiramate 100mg
12014229|NCT00486291|Drug|Placebo|matched placebo
12014230|NCT00486278|Drug|eptacog alfa (activated)|90 mcg/kg, injected i.v.
12014231|NCT00486278|Drug|vatreptacog alfa (activated)|5 mcg/kg, injected i.v.
12014232|NCT00486278|Drug|vatreptacog alfa (activated)|10 mcg/kg, injected i.v.
12014233|NCT00486278|Drug|vatreptacog alfa (activated)|20 mcg/kg, injected i.v.
12014234|NCT00486278|Drug|vatreptacog alfa (activated)|40 mcg/kg, injected i.v.
12014235|NCT00486278|Drug|vatreptacog alfa (activated)|80 mcg/kg, injected i.v.
12014236|NCT00486265|Drug|AZD4877|intravenous infusion administered on days 1, 2 and 3
12014237|NCT00486252|Other|Observational|This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.
12014238|NCT00486239|Behavioral|neuropsychological evaluation|
12014239|NCT00486226|Device|Vascular Reconstruction Device|CORDIS ENTERPRISE™ VRD
12014240|NCT00486213|Dietary Supplement|pyridoxine hydrochloride|Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
12014241|NCT00486213|Other|Placebo|
12014242|NCT00486200|Drug|ASP2151|Oral administration.
12014243|NCT00486200|Drug|valacyclovir|Oral administration of active comparator.
12014244|NCT00486200|Drug|Placebo|Oral administration of placebo.
12014245|NCT00486187|Drug|rosiglitazone|
12014246|NCT00486187|Drug|metformin or sulfonylurea|
12014247|NCT00486174|Drug|methylene blue|2.0 mg/kg of Methylene Blue administered every 6 hours (as required) for up to 48 hours.
12014248|NCT00486148|Other|Infant formula (with GOS)|Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides
12014249|NCT00486135|Drug|XL147 (SAR245408)|Gelatin capsules supplied in 25-mg and 100-mg dosage strengths
12014250|NCT00486135|Drug|XL147 (SAR245408)|Tablets supplied as 100-mg, 150-mg, and 200-mg dosage strengths
12014251|NCT00486122|Drug|Atomoxetine Hydrochloride|
12014252|NCT00486122|Drug|Placebo|
12014253|NCT00486109|Device|I-Port(TM) Injection Port|
12014254|NCT00486083|Drug|Atomoxetine Hydrochloride|
12014255|NCT00486083|Drug|Methylphenidate Hydrochloride|
12014256|NCT00486044|Drug|Simvastatin|40 mg tablet each night for one month, then 80 mg for 8 months
12014257|NCT00486044|Drug|Placebo|Matching tablet each night for 9 months
12014258|NCT00486031|Drug|Balsalazide Disodium|
12014259|NCT00486018|Drug|Ranibizumab injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
12014260|NCT00486018|Drug|Ranibizumab injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
12014261|NCT00486018|Drug|Sham injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
12014262|NCT00486005|Drug|Olanzapine Hydrochloride|
12014263|NCT00486005|Drug|Nizatidine|
12014264|NCT00486005|Drug|Placebo|
12014265|NCT00485979|Drug|larotaxel (XRP9881)|intravenous administration
12014266|NCT00485979|Drug|docetaxel|intravenous administration
12014267|NCT00485979|Drug|trastuzumab|intravenous administration
12014268|NCT00485966|Drug|CX-3543|360 mg/m2 daily x 5 q 21 days
12014269|NCT00485953|Drug|risedronate|risedronate 35 mg per week
12014270|NCT00485940|Drug|Prucalopride|2 mg o.d.
12014271|NCT00485940|Other|Placebo|Placebo o.d.
12014274|NCT00485914|Behavioral|On-site work evaluation|Researchers will measure the effects of worksite assessment through an on-site work evaluation by an occupational therapist on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through one-to-one contact and an individualized work plan. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space.
12014275|NCT00485914|Behavioral|Educational material|Researchers will measure the effects of worksite assessment through educational materials on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through educational materials to develop strategies to compensate. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space.
12014276|NCT00485901|Drug|Olanzapine Hydrochloride|
12014277|NCT00485901|Drug|Haloperidol|
12014278|NCT00485888|Drug|Cipralex|10-20mg; one per day
12014279|NCT00485888|Drug|Placebo|Matched to Cipralex
12014280|NCT00485875|Drug|Atomoxetine Hydrochloride|
12014281|NCT00485862|Drug|Atomoxetine Hydrochloride|
12014282|NCT00485862|Drug|Sertraline|
12014283|NCT00485862|Drug|Placebo|
12014284|NCT00485849|Drug|Atomoxetine Hydrochloride|
12014285|NCT00485836|Drug|Sham injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
12014286|NCT00485836|Drug|Ranibizumab injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
12014287|NCT00485836|Drug|Ranibizumab injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
12014288|NCT00485823|Drug|Olanzapine Hydrochloride|
12014289|NCT00485823|Procedure|Weight Management Program|
12014290|NCT00485810|Drug|Olanzapine Hydrochloride|
12014291|NCT00485797|Drug|Ritalin|The effect of ritalin on postural stability of ADHD childrens will be measured using RCT study design
12014292|NCT00485784|Other|Blood test|Blood test
12014293|NCT00485771|Drug|Olanzapine|
12014294|NCT00485771|Drug|Fluoxetine|
12014295|NCT00485771|Drug|Lamotrigine|
12014296|NCT00485758|Drug|ER niacin/laropiprant|One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.
12014297|NCT00485758|Drug|Comparator : placebo (unspecified)|ER niacin/laropiprant Placebo
12014298|NCT00485732|Biological|HPV-16/18 VLP/AS04 vaccine (Cervarix TM)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12014299|NCT00485732|Biological|Placebo|Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.
12014300|NCT00485719|Drug|XL765 (SAR245409)|Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally
12014301|NCT00485706|Procedure|high calcium dialysate|
12014302|NCT00485693|Drug|Bupivacaine HCl|150 mg Bupivacaine HCl
12014303|NCT00485693|Drug|SKY0402|600 mg SKY0402 (study drug)
12014304|NCT00485680|Drug|Olanzapine Hydrochloride|
12014305|NCT00485680|Drug|Lithium Carbonate|
12014306|NCT00485667|Drug|SKY0402|Subects received either 300mg or 450mg
12014307|NCT00485667|Drug|Moxifloxacin 400mg|
12014308|NCT00485667|Drug|Placebo injection|
12014309|NCT00485667|Drug|Placebo tablet|
12014310|NCT00485641|Device|SaeboFlex Dynamic Hand Orthosis|
12014311|NCT00485641|Procedure|Saebo F.T.M. Arm Training Program|
12014312|NCT00485628|Drug|Atomoxetine Hydrochloride|
12014313|NCT00485615|Drug|Omega 3 Joy enteric coated concentrated fish oil|1500-3000mg; one per day
12014314|NCT00485602|Procedure|"orthodontic treatment with Rafenalign appliance"|
12014315|NCT00485589|Drug|Methotrexate|Oral repeating dose
12014316|NCT00485589|Drug|Ocrelizumab|Intravenous repeating dose
12014317|NCT00485589|Drug|Placebo|Intravenous repeating dose
12014318|NCT00485576|Drug|eculizumab|eculizumab 600 mg or matching placebo iv infusion.
12014319|NCT00485563|Biological|EC90 (KLH-FITC)|1.2mg in combination with adjuvant GPI-0100 administered subcutaneously (beneath the skin) weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
12014320|NCT00485563|Biological|GPI-0100|3.0 mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
12014321|NCT00485563|Drug|EC17 (Folate-FITC)|0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks for the first two treatment cycles and then 3 days per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.
12014322|NCT00485563|Drug|Interleukin-2|7.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 2.5 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.
12014323|NCT00485563|Drug|Interferon-alpha|3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.
12014324|NCT00485550|Drug|Atomoxetine Hydrochloride|
12014325|NCT00485550|Drug|Methylphenidate Hydrochloride|
12014326|NCT00485550|Drug|Placebo|
12014327|NCT00485537|Procedure|oocyte retrieval and ICSI procedure|
12014328|NCT00485511|Drug|Hydroxyurea|
12014329|NCT00485498|Drug|Olanzapine Hydrochloride|
12014330|NCT00485498|Drug|Risperidone|
12014331|NCT00485485|Drug|Imatinib Mesylate|400 mg by mouth daily
12014332|NCT00485485|Drug|Docetaxel|60 mg/m^2 by vein (IV) over 1 hour every 3 weeks
12014333|NCT00485472|Drug|lacosamide|50 or 100mg tablet, 400mg daily, for 12 weeks
12014334|NCT00485472|Other|Placebo|50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
12014335|NCT00485459|Drug|Atomoxetine Hydrochloride|
12014336|NCT00485459|Drug|Placebo|
12014337|NCT00485446|Procedure|blood analysis|
12014338|NCT00485433|Drug|Bupivacaine HCl|Bupivacaine HCl given during hernia repair
12014339|NCT00485433|Drug|SKY0402|SKY0402 given during hernia repair
12014340|NCT00485420|Other|Internet based disease management program|Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
12014341|NCT00485407|Drug|Atomoxetine Hydrochloride|
12014342|NCT00485394|Drug|OT-551|OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
12014343|NCT00485394|Drug|OT-551|OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
12014344|NCT00485394|Drug|vehicle placebo|OT-551 0% ophthalmic solution, 2 drops 4 times daily
12014345|NCT00485368|Drug|Coversyl (perindopril)|
12014346|NCT00485355|Procedure|conventional laparoscopic hysterectomy|Total laparoscopic hysterectomy
12014347|NCT00485355|Procedure|robotic assisted laparoscopic hysterectomy|Robotic assisted laparoscopic hysterectomy with DaVinci robot
12014348|NCT00485342|Drug|Peg-interferon alpha 2a and ribavin|"Date of ribavirin AUC : Day 0 (beginning of treatment) Bitherapy : Peg-interferon alpha 2a (180 µg/week) with ribavirin (1000 mg/day if weight < 75 kg and 1200 mg/day if weight ≥ 75 kg).
~Duration of treatment : 48 weeks Duration of study for patients : 72 weeks"
12014349|NCT00485342|Drug|ribavirin with adaptation dose|"Date of ribavirin AUC : Day 0 (beginning of treatment) Bitherapy : Peg-interferon alpha 2a (180 µg/week) with ribavirin (dose adaptation) Dose adaptation : Day 7, dependant of result of AUC Ribavirin dose increments : 200 mg, 400 mg or 600 mg with a maximum of 50% of the initial dose (600 mg) applied every 4 days up to the adjusted dose proposed in order to reach the targeted AUC.
~The maximum daily dose will not exceed 3600 mg Duration of treatment : 48 weeks Duration of study for patients : 72 weeks"
12014350|NCT00485329|Other|Papain|15,000 USP U/ml
12014351|NCT00485329|Other|Papain|30,000 USP U/ml
12014352|NCT00485329|Other|Papain|60,000 USP U/ml
12014353|NCT00485316|Procedure|Laparoscopic assisted resection of colorectal carcinoma|
12014354|NCT00485303|Drug|Abiraterone acetate|Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.
12014355|NCT00485303|Drug|Prednisone|Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.
12014356|NCT00485290|Behavioral|meal (food intake)|600 kcal. (16% protein, 49%carbohydrate, 35% fatt)
12014357|NCT00485277|Biological|MVA-BN-HER2|Experimental vaccine, subcutaneous injection q3weeks x 3
12014358|NCT00485264|Drug|Raltegravir poloxamer film coated tablet|Final Selected Dose: 400-mg tablet taken orally twice daily.
12014359|NCT00485264|Drug|Raltegravir chewable tablet|Final Selected Dose: Weight based dose of ~6 mg/kg according to the dosing table, to a maximum dose of 300 mg, taken orally twice daily.
12014360|NCT00485264|Drug|Raltegravir oral granules for suspension (20 mg/mL)|Weight based dose of ~6 mg/kg orally every 12 hours according to dosing table in protocol or the dose determined by review of all available data.
12014361|NCT00485264|Drug|Raltegravir poloxamer film coated tablet|Final Selected Dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg. Participants < 25 kg were switched to a weight-based dose of the chewable tablet.
12014362|NCT00485251|Procedure|hand-assisted laparoscopic right hemicolectomy|using the lap disc that allows the insertion of single and into the abdomen for operation
12014363|NCT00485251|Procedure|total laparoscopic right hemicolectomy|using laparoscopic instruments for mobilization and dissection inside the abdomen
12014364|NCT00485251|Procedure|hand-assisted right hemicolectomy|hand-assisted right hemicolectomy
12014365|NCT00485251|Procedure|laparoscopic right hemicolectomy|using laparoscopic instruments for mobilization and dissection inside the abdomen
12014366|NCT00485238|Procedure|Argon laser Iridoplasty|
12014367|NCT00485238|Drug|Intravenous acetazolamide|
12014368|NCT00485225|Drug|EN3270|Transdermal Therapeutic System
12014369|NCT00485212|Device|compression bandage|
12014370|NCT00485199|Procedure|Pneumatic Retinopexy|
12014371|NCT00485199|Procedure|Vitrectomy with Gas|
12014372|NCT00485173|Device|INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate|All patients enrolled in this study will receive the investigational device.
12014373|NCT00485160|Drug|Continuous indomethacin|
12014374|NCT00485160|Drug|ibuprofen|
12014375|NCT00485147|Procedure|Recording of GPS during a free walking in a public park|Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.
12014376|NCT00485134|Biological|240 µg Shigella flexneri 2a Invaplex 50 vaccine|Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
12014377|NCT00485134|Biological|480 µg Shigella flexneri 2a Invaplex 50 vaccine|Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
12014378|NCT00485134|Biological|690 Shigella flexneri 2a Invaplex 50 vaccine|Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
12014379|NCT00485134|Other|Shigella challenge strain|300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T
12014380|NCT00485121|Drug|Ezetimibe|
12014381|NCT00485108|Drug|prednisolone 1%|eye drop once in each eye treated, 4 times / day for 5 days post-laser
12014382|NCT00485108|Drug|ketorolac 0.5%|eye drop once in each eye treated, 4 times / day for 5 days post-laser
12014383|NCT00485108|Drug|Artificial Tears (Methyl cellulose drops)|eye drop once in each eye treated, 4 times / day for 5 days post-laser
12014384|NCT00485095|Behavioral|Intake of plant sterols|
12014445|NCT00484562|Device|Helios oxygen delivery system|Liquid oxygen portable system pre-filled from a larger liquid oxygen tank
12014507|NCT00484120|Drug|3%-Diclofenac-Nano-Emulsion Cream|3%-Diclofenac-Nano-Emulsion Cream
12014385|NCT00485069|Drug|ROP|Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study.
12014386|NCT00485069|Drug|ROP+L-Dopa|Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
12014387|NCT00485056|Drug|Pioglitazone|45mgs daily
12014388|NCT00485043|Behavioral|Modified T'ai Chi: T'ai Chi for Arthritis|
12014389|NCT00485030|Device|Cypher|sirolimus-eluting stent
12014390|NCT00485030|Device|Xience-V|everolimus-eluting stent
12014391|NCT00485017|Drug|THR-4109|THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks
12014392|NCT00485017|Drug|Placebo|Oral capsules daily in a.m. and in p.m. for 24 weeks
12014393|NCT00485004|Device|Cutting balloon|Cutting balloon
12014394|NCT00485004|Device|Sirolimus-eluting stent|Sirolimus-eluting stent
12014395|NCT00484991|Drug|Sapropterin dihydrochloride|20mg/kg/day orally, physicians may adjust the dose within a range of 5-20mg/kg/day as warranted by their clinical judgment.
12014396|NCT00484978|Procedure|Stereotactic Radiosurgery|
12014397|NCT00484965|Procedure|Coronary stenting|
12014398|NCT00484939|Drug|Bevacizumab|Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
12014399|NCT00484939|Drug|Capecitabine|Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
12014400|NCT00484926|Drug|Aspirin monotherapy|stopping clopidogrel at 1 year after DES
12014401|NCT00484926|Drug|Aspirin,Clopidogrel|continue aspirin and clopidogrel 1year after DES
12014402|NCT00484913|Procedure|abdominal hot compress|
12014403|NCT00484900|Drug|Co-Arinate FDC|
12014404|NCT00484900|Drug|Coartem|
12014405|NCT00484874|Drug|I-131 Tositumomab therapeutic regimen|Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.
12014406|NCT00484848|Device|Vortex port and Celsite port|
12014407|NCT00484835|Procedure|Performing abdominal hysterectomy using gyrus electrocoagulation forceps|
12014408|NCT00484822|Drug|Bemiparina Sodica|3.500 UI/día.
12014409|NCT00484822|Drug|Heparina Cálcica|10.000 UI/día.
12014410|NCT00484809|Drug|Enbrel (Etanercept)|
12014411|NCT00484796|Procedure|MED-SEP|intraoperative neurophysiological monitoring
12014412|NCT00484796|Procedure|TRI-SEP|intraoperative neurophysiologic monitoring
12014413|NCT00484796|Procedure|neuropsychological tests|neurological short- and longterm outcome
12014414|NCT00484783|Procedure|Natural Orifice Transluminal Endoscopic Surgery (NOTES)|Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.
12014415|NCT00484783|Procedure|Natural Orifice Translumenal Endoscopic Surgery (NOTES)|chart review of historical data from control group
12014416|NCT00484770|Device|Brain Natriuretic Peptide Levels -- Diagnostic testing|
12014417|NCT00484770|Other|clinical assessment|
12014418|NCT00484757|Drug|Orexine A|
12014419|NCT00484744|Drug|Acetaminophen|
12014420|NCT00484744|Drug|Avicel (placebo)|
12014421|NCT00484744|Drug|Ibuprofen|
12014422|NCT00484731|Procedure|Infiltration with Saline|Infiltration with Bupivacaine according to protocol
12014423|NCT00484731|Procedure|Infiltration with Bupivacaine|
12014424|NCT00484718|Drug|celecoxib|oral, 100 mg bid
12014425|NCT00484718|Drug|Oxycodone|oral, 20 mg bid
12014426|NCT00484718|Drug|placebo|oral bid
12014427|NCT00484705|Procedure|Electroacupuncture|
12014428|NCT00484705|Procedure|Physical exercise|
12014429|NCT00484705|Procedure|Untreated control|
12014430|NCT00484692|Drug|sustained-release bupropion (Zyban(R))|
12014431|NCT00484692|Behavioral|Psychodynamic Model Training (R) = PDM(R)|
12014432|NCT00484679|Drug|Triamcinolone Acetonide 10 mg/mL (Kenalog-10)|Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection
12014433|NCT00484653|Procedure|cervical smear|biological analysis
12014434|NCT00484640|Drug|Coumadin|
12014435|NCT00484627|Procedure|Use of creatine monohydrate (a dietary supplement)|
12014436|NCT00484627|Behavioral|Progressive resistance exercise training|
12014437|NCT00484614|Procedure|Positron Emission Mammography|Molecular Imaging Device
12014438|NCT00484614|Procedure|Magnetic Resonance Imaging|Imaging Device
12014439|NCT00484601|Drug|Ifosfamide|
12014440|NCT00484601|Drug|Doxorubicin|
12014441|NCT00484575|Drug|Sevoflurane|given by infusion via AnaConDa for sedation with target MAAS 2-3
12014442|NCT00484575|Drug|propofol|propofol given intravenously for sedation in control group
12014443|NCT00484562|Device|Standard oxygen delivery system|Standard oxygen tank with pulse dose regulator
12014444|NCT00484562|Device|Homefill oxygen delivery system|Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
12014505|NCT00484133|Drug|nitroglycerine|
12014506|NCT00484133|Drug|noradrenaline|
12014446|NCT00484562|Device|FreeStyle oxygen system|portable battery-powered oxygen concentrator delivery system
12014447|NCT00484549|Procedure|Blood sample|Ischemic stroke hospitalized
12014448|NCT00484536|Drug|CDP323|250 mg capsules, 500 mg bid (1000 mg/day)
12014449|NCT00484536|Drug|placebo|capsules, once daily
12014450|NCT00484536|Drug|CDP323|250 mg Capsules, 500 mg, once daily
12014451|NCT00484523|Procedure|SPET, PET and MRI|60 healthy subjects after a a consultation with a neurologist for wich 4 examinations will be programmed in two days ( 1 cerebral MRI, 1pet scan, 1 spet, 1 datascan
12014452|NCT00484510|Drug|Ascorbic acid (Vitamin C)|Eight 500 mg capsules/day of ascorbic acid. Subjects will take four (4)capsules each morning and four (4) capsules each evening for 24 months. (Total 4 gr/day).
12014453|NCT00484510|Drug|placebo|Eight 500 mg capsules/day of placebo. Subjects will take four (4)capsules each morning and four (4) capsules each evening for 24 months.
12014454|NCT00484497|Drug|cyclamax|
12014455|NCT00484484|Drug|Ketamine|Ketamine
12014456|NCT00484471|Drug|aripiprazole|15-30 mg/day aripiprazole, 22 weeks
12014457|NCT00484471|Drug|valproate|sufficient dose as determined by investigator to maintain the therapeutic level.
12014458|NCT00484471|Drug|placebo|placebo to aripiprazole, 22 weeks
12014459|NCT00484458|Device|Interspinous process and dynamic stabilization (Wallis System)|Interspinous stabilization
12014460|NCT00484458|Device|Total Disc Replacement|Total disc
12014461|NCT00484432|Drug|NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs
12014462|NCT00484432|Drug|doxorubicin|Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²
12014463|NCT00484419|Drug|Colesevelam HCl|coleveselam tablets 625 mg; 6 tablets/day
12014464|NCT00484419|Drug|rosiglitazone maleate|rosiglitazone tablets 4mg
12014465|NCT00484419|Drug|sitagliptin phosphate|sitagliptin phosphate tablets 100mg/day
12014466|NCT00484393|Drug|tetracaine 4% gel|tetracaine applied prior to 1 injection
12014467|NCT00484393|Drug|Placebo|placebo applied prior to 1 injection
12014468|NCT00484380|Procedure|Coronary scanner|multislice spiral computed tomography coronary angiography
12014469|NCT00484367|Behavioral|Adolescent group therapy|Adolescent group therapy
12014470|NCT00484367|Behavioral|Transitional family therapy|Transitional family therapy
12014471|NCT00484354|Drug|Sodium bicarbonate|IV bicarbonate given with amount based on patient weight
12014472|NCT00484354|Other|Normal saline|IV Normal saline with volume given determined by patient weight
12014473|NCT00484354|Other|Bicarbonate|IV bicarbonate, dosed by weight
12014474|NCT00484354|Other|Placebo|Normal saline, with volume given based on patient weight
12014475|NCT00484341|Drug|low-dose NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
12014476|NCT00484341|Drug|high-dose NGR-hTNF|NGR-hTNF: 45 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
12014477|NCT00484341|Drug|Doxorubicin|Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion) on day 1 every 3 weeks for a maximum of 6 cycles or until cumulative dose of 550 mg/m²
12014478|NCT00484328|Drug|Ribavirin|different dosing regimes of Ribavirin
12014479|NCT00484315|Device|Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation|TAXUS Element stent placement
12014480|NCT00484315|Device|Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement|TAXUS Express Stent Implant
12014481|NCT00484302|Behavioral|Cognitive behavioral therapy with motivational interviewing|Individual and group therapy, education of family and case-manager.
12014482|NCT00484302|Behavioral|Non-manualized standard treatment|Treatment by case-manager
12014483|NCT00484289|Drug|Abatacept|Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
12014484|NCT00484276|Drug|NGR-hTNF|iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
12014485|NCT00484263|Drug|Hypertonic saline 6% -|Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months
12014486|NCT00484250|Drug|metronidazole,doxycycline|
12014487|NCT00484237|Drug|etanercept|
12014488|NCT00484211|Drug|NGR-hTNF|iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
12014489|NCT00484198|Drug|pioglitazone|Tablets
12014490|NCT00484198|Drug|placebo|Tablets
12014491|NCT00484198|Drug|rivoglitazone HCl|Tablets
12014492|NCT00484198|Drug|rivoglitazone HCl|Tablets
12014493|NCT00484185|Drug|BeneFIX (coagulation factor IX (recombinant))|BeneFIX will be administered according to physician's discretion.
12014494|NCT00484172|Procedure|blood draws|
12014495|NCT00484159|Procedure|Radiofrequency denervation of medial branches|Radiofrequency of medial branches that innervate the lumbar facet joints
12014496|NCT00484159|Drug|0.5% bupivacaine|Diagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic.
12014497|NCT00484159|Drug|2% lidocaine|Diagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic.
12014498|NCT00484159|Procedure|Radiofrequency denervation|Radiofrequency lumbar facet denervation without a diagnostic block
12014499|NCT00484159|Procedure|Radiofrequency denervation|Radiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks.
12014500|NCT00484159|Procedure|Radiofrequency denervation|Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block
12014501|NCT00484159|Procedure|Radiofrequency denervation|Radiofrequency lumbar facet denervation without a diagnostic facet block.
12014502|NCT00484133|Drug|Dopamine|
12014503|NCT00484133|Drug|dobutamine|
12014504|NCT00484133|Drug|enoximone|
12014508|NCT00484120|Drug|Placebo cream|Placebo cream
12014509|NCT00484107|Drug|Conjugated Estrogen Cream (Premarin®)|
12014510|NCT00484094|Drug|sirolimus|Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
12014511|NCT00484081|Procedure|Microdissection Testicular Sperm Extraction|
12014512|NCT00484081|Procedure|ICSI|
12014513|NCT00484068|Drug|enalapril|
12014514|NCT00484068|Procedure|chicken diet|
12014515|NCT00484055|Drug|Local application of collagen-gentamicin|Application of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure
12014516|NCT00484055|Procedure|Fixation of the sternotomy with more than six wires|At least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure
12014517|NCT00484029|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
12014518|NCT00484029|Other|Air|Air (Medical Grade)
12014519|NCT00484003|Drug|Pimecrolimus cream 1%|
12014520|NCT00483990|Drug|PSD502|
12014521|NCT00483977|Drug|Oxycodone|Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
12014522|NCT00483977|Drug|Placebo|Placebo: oral for 2 weeks.
12014523|NCT00483977|Drug|PF-000592379|PF-00592379: oral, 30 mg, once a day for 2 weeks
12014524|NCT00483964|Drug|Bacopa monnieri|
12014525|NCT00483964|Drug|Nardostachys jatamansi|
12014526|NCT00483964|Drug|Olanzapine|
12014527|NCT00483951|Device|Toshiba Aquilion ONE CT|The Toshiba Aquilion ONE CT system is currently being used for studies in both general CT radiology and CT cardiac imaging. One of the unique aspects of the Aquilion ONE CT system is its ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy. In line with the evolutionary changes to CT systems, the Aquilion ONE will be upgraded with new technology that will expand its capabilities. The changes being made to the Aquilion ONE will provide enhancements to image acquisition capabilities, reduce ionizing radiation dose, and improve subject access to the system. All of these features assist in enhancing the safety of the currently installed Aquilion ONE CT system.
12014528|NCT00483951|Device|SWiemens MRI scanner|Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.
12014529|NCT00483938|Drug|Pegylated-interferon Alfa-2a|Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
12014530|NCT00483938|Drug|Ribavirin|Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
12014531|NCT00483912|Device|Molecular adsorbent recirculating system|
12014532|NCT00483899|Drug|GW870086X|Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
12014533|NCT00483899|Drug|Placebo|Placebo matching GW870086X will be administered by subjects
12014534|NCT00483886|Drug|Prucalopride|2 mg o.d.
12014535|NCT00483886|Other|Placebo|Placebo o.d.
12014536|NCT00483886|Drug|Prucalopride|4 mg o.d.
12014537|NCT00483860|Drug|Topotecan|once a day
12014538|NCT00483834|Drug|Bevacizumab|7.5mg/kg, IV, day 1 of each cycle
12014539|NCT00483834|Drug|Irinotecan|200mg/m^2, IV, day 1 each cycle
12014540|NCT00483834|Drug|Capecitabine|1000mg/m^2 or 750mg/m^2 for patients over 65yrs old PO BID, day 1-14 each cycle
12014541|NCT00483821|Other|medical chart review|medical chart review
12014542|NCT00483808|Device|Ardian Symplicity™ Catheter|Renal denervation using the Symplicity Catheter
12014543|NCT00483795|Drug|sodium citrate, sodium chloride, sodium borate, propylene glycol. citrate, tetronic 1304, AMP 95|
12014544|NCT00483782|Biological|bevacizumab|
12014545|NCT00483782|Drug|carboplatin|
12014546|NCT00483782|Drug|paclitaxel|
12014547|NCT00483782|Other|questionnaire administration|
12014548|NCT00483782|Other|study of socioeconomic and demographic variables|
12014549|NCT00483782|Procedure|quality-of-life assessment|
12014550|NCT00483769|Drug|Glargine|
12014551|NCT00483756|Drug|Cyclosporine|Standard of care
12014552|NCT00483756|Drug|CP-690,550|CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12
12014553|NCT00483756|Drug|CP-690,550|CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
12014554|NCT00483743|Drug|TPI 1020|250 mcg/caps 2 caps BID x 42 days
12014555|NCT00483743|Drug|Budesonide|400mcg mcg capsules- 2 capsules BID
12014556|NCT00483743|Drug|Placebo|2 caps BID x42 days
12014557|NCT00483730|Drug|Deproteinised hemoderivative of calf blood (Actovegin)|Symptomatic diabetic peripheral polyneuropathy
12014558|NCT00483717|Drug|Ketorolac tromethamine|31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
12014559|NCT00483717|Drug|Placebo|Intranasal (IN) placebo
12014560|NCT00483704|Drug|Telcagepant 140 mg|Telcagepant 140 mg tablets
12014561|NCT00483704|Drug|Talcagepant 280 mg|Telcagepant 280 mg tablets
12014562|NCT00483704|Drug|Placebo|Placebo tablets
12014563|NCT00483691|Behavioral|Home Visit|Homw visits scheduled weekly for one year.
12014564|NCT00483678|Other|counseling intervention|
12014565|NCT00483678|Other|questionnaire administration|
12014566|NCT00483678|Procedure|psychosocial assessment and care|
12014567|NCT00483665|Procedure|Computed tomography angiography|Computed tomography angiography
12014568|NCT00483665|Procedure|Magnetic resonance imaging|Magnetic resonance imaging after injection of Vasovist
12014569|NCT00483652|Drug|Fampridine-SR|Tablets, 10 mg, twice daily, 9 weeks
12014570|NCT00483652|Drug|Placebo|placebo (sugar pill)
12014571|NCT00483639|Other|Medical chart review|medical chart review
12014572|NCT00483639|Other|Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory|survey administration
12014573|NCT00483639|Procedure|management of therapy complications|management of therapy complications
12014574|NCT00483639|Procedure|Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID|psychosocial assessment
12014575|NCT00483639|Other|Functional Assessment of Cancer Therapy-General (FACT-G)|survey administration
12014576|NCT00483626|Drug|oral sildenafil|
12014577|NCT00483613|Behavioral|Cognitive-behavioral therapy of Meichenbaum|
12014578|NCT00483600|Drug|fondaparinux|injections of 2.5mg every other day for 4 weeks
12014579|NCT00483587|Drug|Heme arginate|1-3 x heme arginate infusion, in 30 minutes iv. Heme arginate is dissolved in 250 ml NACl.
12014580|NCT00483574|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, IM at age 9 and 12 months
12014581|NCT00483574|Biological|Measles-mumps-rubella-varicella vaccine|0.5 mL, intramuscular at 12 months of age
12014582|NCT00483574|Biological|Routine paediatric vaccine - Pneumococcal conjugate (PCV)|0.5 mL, Intramuscular at age 12 months
12014583|NCT00483574|Biological|Routine paediatric vaccine - Hepatitis A|0.5 mL, Intramuscular at age 12 months
12014584|NCT00483561|Drug|Gefitinib plus etoposide|Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
12014585|NCT00483548|Drug|Ziprasidone|Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
12014586|NCT00483548|Drug|Placebo|Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
12014587|NCT00483535|Drug|GW273225|GW273225 will be available as 25 milligram tablets.
12014588|NCT00483535|Drug|COC|COC will consist of Microgynon 30 which is available as ethinylestradiol 30 micrograms/levonorgestrel 150 micrograms beige color, sugar-coated tablets.
12014589|NCT00483522|Behavioral|Self-management telephone counseling|Subjects are contacted 7 times in year 1 after discharge from hospital rehabilitation unit and 4 times in year 2. Telephone counseling based on a self-management/problem-solving model is conducted by a research care manager.
12014590|NCT00483509|Drug|NGR-hTNF|iv q3W 0.8 mcg/sqm NGR-hTNF
12014591|NCT00483509|Drug|Doxorubicin|iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion
12014592|NCT00483496|Drug|Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)|
12014593|NCT00483496|Drug|Ti02 pigmentary 3% alone (formula RV3131A-MV1211)|
12014594|NCT00483496|Drug|bisoctrizole 10% alone (formula RV3131A-MV1237)|
12014595|NCT00483496|Drug|Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)|
12014596|NCT00483496|Drug|Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)|
12014597|NCT00483496|Drug|Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)|
12014598|NCT00483496|Drug|Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]|
12014599|NCT00483496|Drug|V0096 CR vehicle (formula RV3131A-MV1197)|
12014600|NCT00483483|Behavioral|Individual and group HIV risk behavior counseling sessions|Healthy Relationships Intervention (HRI) culturally adapted and modified to address substance use and associated risk behaviors; subjects will attend three 2-hour structured group sessions in addition to two 1-hour individualized sessions over the course of 10 days.
12014601|NCT00483483|Behavioral|health education and support group|general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.
12014602|NCT00483470|Biological|Hepatitis A vaccine AVAXIM 80U|0.5 mL, Intramuscular
12014603|NCT00483470|Biological|Hepatitis A vaccine (HAVRIX 720)|0.5 mL, Intramuscular
12014604|NCT00483457|Drug|enzyme inhibitor therapy|enzyme inhibitor therapy
12014605|NCT00483457|Genetic|protein expression analysis|protein expression analysis
12014606|NCT00483457|Other|immunohistochemistry staining method|immunohistochemistry staining method
12014607|NCT00483457|Other|laboratory biomarker analysis|laboratory biomarker analysis
12014608|NCT00483457|Procedure|biopsy|biopsy
12014609|NCT00483444|Behavioral|Scheduled telephone follow-up|Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.
12014610|NCT00483431|Dietary Supplement|Placebo|
12014611|NCT00483431|Dietary Supplement|MK7|
12014612|NCT00483405|Biological|cetuximab|250 mg/m2, intravenously, once per week
12014613|NCT00483405|Drug|capecitabine|850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
12014614|NCT00483405|Drug|oxaliplatin|130 mg/m2, intravenously on Day 1 of each 21 day cycle
12014615|NCT00483392|Drug|metformin, rosiglitazone|
12014616|NCT00483379|Biological|alglucosidase alfa|intravenous infusion
12014617|NCT00483366|Drug|capecitabine|"Dose level Capecitabine
~-1 400 mg/m2 bid
~0 500 mg/m2 bid
~500 mg/m2 bid
~600 mg/m2 bid
~600 mg/m2 bid
~725 mg/m2 bid
~725 mg/m2 bid
~850 mg/m2 bid
~850 mg/m2 bid"
12014618|NCT00483366|Drug|gemcitabine hydrochloride|"Dose level Gemcitabine
~-1 400 mg/m2 0 450 mg/m2
~550 mg/m2
~550 mg/m2
~675 mg/m2
~675 mg/m2
~825 mg/m2
~825 mg/m2
~1000 mg/m2"
12014619|NCT00483366|Drug|imatinib mesylate|"Dose level Imatinib
~-1 400 mg/d 0 400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d"
12014620|NCT00483366|Genetic|mutation analysis|C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.
12014621|NCT00483366|Genetic|nucleic acid sequencing|C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.
12014734|NCT00482651|Procedure|Coronary angiography (CAG)|CAG and if necessary PCI. Included patients are already assigned for CAG
12014622|NCT00483366|Genetic|polymerase chain reaction|C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.
12014623|NCT00483353|Procedure|Intra-nasal allergen challenge with Phleum pratense.|
12014624|NCT00483353|Procedure|Collection of nasal effluent using filter paper.|
12014625|NCT00483353|Procedure|Measurement of nasal congestion using acoustic rhinometry.|
12014626|NCT00483327|Drug|Megestrol Acetate|
12014627|NCT00483314|Drug|N-acetylcysteine|2 g p.o. BID x 60 days
12014628|NCT00483301|Drug|Sorafenib (BAY 43-9006)|dosage
12014629|NCT00483301|Drug|ABI-007(Abraxane)|dosage
12014630|NCT00483288|Other|educational intervention|
12014631|NCT00483288|Other|questionnaire administration|
12014632|NCT00483288|Other|study of socioeconomic and demographic variables|
12014633|NCT00483288|Other|survey administration|
12014634|NCT00483275|Drug|Alfacalcidol|
12014635|NCT00483275|Behavioral|Balance, gait and strength training|
12014636|NCT00483275|Behavioral|Patient education|
12014637|NCT00483262|Drug|CCI-779|Given by injection once a week for 5 weeks (5 weeks equals one cycle) for up to 8 cycles
12014638|NCT00483262|Drug|Bortezomib|Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles
12014639|NCT00483249|Device|Endovascular Branched Stent-Graft|Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
12014640|NCT00483223|Drug|Cisplatin|Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
12014641|NCT00483223|Drug|carboplatin|Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
12014642|NCT00483210|Drug|Fenofibrate|
12014643|NCT00483197|Device|VentrAssistTM Left Ventricular Assist Device|
12014644|NCT00483184|Biological|Veldona,|Very low dose oral natural human interferon alpha lozenges
12014645|NCT00483171|Drug|CP-945,598|CP-945,598
12014646|NCT00483171|Behavioral|Non-pharmacological weight loss program (NPP)|Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
12014647|NCT00483171|Behavioral|Low Calorie Diet|Low calorie diet
12014648|NCT00483158|Drug|Finafloxacin hydrochloride|Tablets, oral single dose and multiple dose once daily for 7d
12014649|NCT00483145|Device|Long-pulsed dye laser (Candela) and PDT (methylaminolevulinate)|
12014650|NCT00483145|Device|Long-pulsed dye laser|
12014651|NCT00483145|Device|Long-pulsed dye laser assisted fotodynamic therapy (methylaminolevulinate)|
12014652|NCT00483132|Drug|interferon alpha 2a|
12014653|NCT00483119|Drug|intravenous immunoglobulin|Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
12014654|NCT00483119|Drug|cyclophosphamide|cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
12014655|NCT00483106|Drug|Ritalin|0.25 mg/kg bid, orally for 7 consecutive days
12014656|NCT00483106|Drug|Placebo|taken orally twice a day for 7 consecutive days
12014657|NCT00483093|Drug|NGR-hTNF|iv q3W escalating dose NGR-hTNF up to 1.6 mcg/sqm
12014658|NCT00483093|Drug|Cisplatin|iv q3W 80 mg/sqm 30 minutes after NGR-hTNF infusion for a maximum of six cycles
12014659|NCT00483080|Drug|NGR-hTNF|iv q3W or q1W NGR-hTNF 0.8 μg/m²
12014660|NCT00483067|Drug|2-CdA|12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days
12014661|NCT00483067|Drug|Ara-C|1 gm/m^2/day IV Over 2 Hours x 5 Days
12014662|NCT00483067|Drug|G-CSF (Granulocyte colony-stimulating factor)|5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
12014663|NCT00483054|Drug|efavirenz|efavirenz 600 mg/day + stavudine + lamivudine
12014664|NCT00483054|Drug|nevirapine|nevirapine 400 mg/day + stavudine +lamivudine
12014665|NCT00483041|Other|PLACEBO|Placebo administered as a single intravenous infusion
12014666|NCT00483041|Biological|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
12014667|NCT00483028|Drug|donezepil (Aricept)|
12014668|NCT00483015|Behavioral|smoking|
12014669|NCT00483002|Drug|varenicline|As prescribed by physician in usual clinical practice.
12014670|NCT00482989|Biological|MEDI 545|"MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial.
~Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."
12014671|NCT00482989|Other|Placebo|"Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial.
~Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."
12014672|NCT00482976|Drug|Ruboxistaurin|
12014673|NCT00482976|Drug|Placebo|
12014674|NCT00482963|Drug|levonorgestrel, efavirenz|
12014675|NCT00482950|Drug|PHX1149T|
12014676|NCT00482937|Drug|CD-NP|
12014677|NCT00482924|Other|Lifestyle intervention|Regular sports and dietary advices. Controlled by analysis of laboratory parameters, BMI change and performance diagnostics. No drugs included so far.
12014678|NCT00482911|Drug|cyclophosphamide|25-50 mg by mouth once daily on days 1-28.
12014679|NCT00482911|Drug|lenalidomide|10 mg by mouth once daily on days 1-28.
12014680|NCT00482911|Drug|sunitinib malate|12.5 - 25 mg by mouth once daily on days 1-28.
12014681|NCT00482898|Drug|MK0359|
12014682|NCT00482872|Genetic|gene expression analysis|
12014683|NCT00482872|Genetic|mutation analysis|
12014684|NCT00482872|Genetic|polymerase chain reaction|
12014685|NCT00482872|Genetic|polymorphism analysis|
12014686|NCT00482872|Other|flow cytometry|
12014687|NCT00482872|Other|laboratory biomarker analysis|
12014688|NCT00482846|Biological|Palifermin|Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
12014689|NCT00482846|Drug|melphalan|"Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:
~Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;
~Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:
~Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;"
12014690|NCT00482846|Other|questionnaire administration|Day -5 to Day +28
12014691|NCT00482846|Procedure|autologous peripheral blood stem cell transplantation|Day 0
12014692|NCT00482846|Other|quality-of-life assessment|Day -5 to Day +28
12014693|NCT00482833|Drug|arsenic trioxide|"Induction Arsenic Trioxide (As2O3=ATO), 0.15 mg/Kg IV over 2 hours daily starting on day 1. ATO will be continued until hematological CR or for a maximum of 60 days.
~Consolidation ATO, 0.15 mg/Kg IV over 2 hours daily for 5 days every week. Treatment will be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles (last cycle administered on weeks 25 - 28)."
12014694|NCT00482833|Drug|idarubicin|"Induction
~Idarubicin, 12 mg/m² on days 2, 4, 6 and 8 by short (20') intravenous infusion .
~If no hematological CR is achieved by 60 days after start of induction, patient will go off-study.
~Consolidation
~1st cycle Idarubicin, 5 mg/m2/day by short (20') intravenous infusion on days 1, 2, 3, 4.
~3rd cycle Idarubicin, 12 mg/m2/day as short (20') intravenous infusion only on day 1."
12014695|NCT00482833|Drug|mercaptopurine|Maintenance therapy 6-Mercaptopurine (6-MP), 50 mg/m2/day orally. The dose will be adjusted according to hematopoietic toxicity during the follow-up period
12014696|NCT00482833|Drug|methotrexate|Maintenance therapy Methotrexate (MTX), 15 mg/m2/weekly intramuscularly. The dose will be adjusted according to toxicity during the follow-up period.
12014697|NCT00482833|Drug|all-trans retinoic acid|"Induction ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological CR and for a maximum of 60 days.
~Consolidation
~st cycle ATRA, 45 mg/m2/day, will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
~nd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
~rd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
~Maintenance therapy
~ATRA, 45 mg/m2/day orally, for 15 days every three months until a two year period is completed."
12014698|NCT00482833|Drug|all-trans retinoic acid (ATRA)|"Induction All-trans retinoic acid (ATRA), 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological complete remission (CR, see below for definition) or for a maximum of 60 days.
~Consolidation ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment. Treatment will be administered for 2 weeks on 2 weeks off and for a total of 7 cycles (last cycle administered on weeks 25 - 26)."
12014699|NCT00482820|Behavioral|attention-bias training|one group recive an attention training away from threat. The second group, the controll group, recive a placebo training
12014700|NCT00482807|Drug|bicalutamide|
12014701|NCT00482807|Drug|docetaxel|
12014702|NCT00482807|Drug|goserelin|
12014703|NCT00482807|Radiation|intensity-modulated radiation therapy|
12014704|NCT00482781|Biological|Infanrix|
12014705|NCT00482781|Biological|Pediatrix|
12014706|NCT00482768|Behavioral|Practice Facilitation|Clinics in the experimental arm will meet with a trained facilitator to work on change strategies that will improve risk factors for diabetes complications.
12014707|NCT00482755|Drug|sunitinib malate|
12014708|NCT00482755|Other|immunohistochemistry staining method|
12014709|NCT00482755|Other|laboratory biomarker analysis|
12014710|NCT00482755|Other|pharmacological study|
12014711|NCT00482755|Procedure|needle biopsy|
12014712|NCT00482755|Procedure|neoadjuvant therapy|
12014713|NCT00482742|Device|CiTop(TM) Guidewire|
12014714|NCT00482729|Drug|sitagliptin phosphate (+) metformin hydrochloride|sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
12014715|NCT00482729|Drug|metformin|metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
12014716|NCT00482716|Biological|epoetin alfa|
12014717|NCT00482716|Biological|epoetin beta|
12014718|NCT00482716|Dietary Supplement|iron dextran complex|
12014719|NCT00482716|Dietary Supplement|iron sucrose injection|
12014720|NCT00482703|Drug|Dasatinib|tablets, Oral, 100 mg, once daily
12014721|NCT00482703|Drug|dasatinib|tablets, Oral, 50 mg, twice daily
12014722|NCT00482690|Drug|nicotine polacrilex|
12014723|NCT00482690|Drug|nicotine transdermal system|
12014724|NCT00482690|Drug|nicotine inhaler|
12014725|NCT00482677|Drug|temozolomide|Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.
12014726|NCT00482677|Genetic|DNA methylation analysis|A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms
12014727|NCT00482677|Procedure|quality-of-life assessment|prior to randomization until end of study
12014728|NCT00482677|Radiation|Radiation|Short course radiotherapy
12014729|NCT00482664|Drug|CP-866,087|Tablets for oral administration
12014730|NCT00482664|Drug|CP-866,087|Tablets for oral administration
12014731|NCT00482664|Drug|CP-866,087|Tablets for oral administration
12014732|NCT00482664|Drug|Placebo|Tablets for oral administration
12014733|NCT00482651|Radiation|Multidetector computed tomography scanning|contrast Multidetector CT-scanning
12014799|NCT00482222|Drug|oxaliplatin|
12014735|NCT00482651|Procedure|Intravascular ultrasound|During CAG Intravascular Ultrasound will be performed in the three coronary arteries
12014736|NCT00482651|Procedure|Blood sample|a blood sample at baseline after 3 months and at the end of the follow up (after 12 months)
12014737|NCT00482638|Drug|MK0493|
12014738|NCT00482625|Drug|erlotinib hydrochloride|Given PO
12014739|NCT00482625|Procedure|conventional surgery|Undergo pancreatectomy
12014740|NCT00482625|Other|immunohistochemistry staining method|Correlative studies
12014741|NCT00482625|Genetic|protein expression analysis|Correlative studies
12014742|NCT00482625|Procedure|biopsy|Correlative studies
12014743|NCT00482625|Other|pharmacological study|Correlative studies
12014744|NCT00482625|Other|laboratory biomarker analysis|Correlative studies
12014745|NCT00482612|Drug|Esmirtazapine|Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
12014746|NCT00482612|Drug|Placebo|Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
12014747|NCT00482599|Drug|Sugammadex|2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
12014748|NCT00482586|Other|medical chart review|Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.
12014749|NCT00482586|Other|questionnaire administration|Patients with hepatic neoplasms who undergo Image-guided Therapy
12014750|NCT00482586|Procedure|quality-of-life assessment|Patients with hepatic neoplasms who undergo Image-guided Therapy
12014751|NCT00482573|Procedure|Dental local anesthesia|"2% lidocaine solution with epinephrine 1:100,000
~infusion of 1,8 mL (one cartridge)
~Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)"
12014752|NCT00482573|Procedure|Dental local anesthesia|"2% lidocaine solution without vasoconstrictor
~infusion of 1,8 mL (one cartridge)
~Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)"
12014753|NCT00482560|Drug|Sucrose solution 30%1 ml|
12014754|NCT00482560|Behavioral|Breastfeeding|
12014755|NCT00482547|Device|Hydrogel Silver Salts Coated Latex Urinary Catheter System|Silver-coated catheter
12014756|NCT00482547|Device|Bard silicone elastomer coated latex catheter system|Silicone-coated catheter
12014757|NCT00482521|Drug|CC-4047|Oral CC-4047 once daily on days 1-21 followed by a 7-day recovery period. Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose (MTD) is determined.
12014758|NCT00482508|Drug|Omalizumab|
12014759|NCT00482495|Biological|bevacizumab|
12014760|NCT00482495|Genetic|gene expression analysis|
12014761|NCT00482495|Genetic|protein expression analysis|
12014762|NCT00482495|Other|laboratory biomarker analysis|
12014763|NCT00482482|Behavioral|psychoeducation|on weekly basis for 8 weeks
12014764|NCT00482482|Behavioral|Yoga|on weekly basis for 8 weeks
12014765|NCT00482456|Drug|Nitrous oxide|
12014766|NCT00482443|Other|A software programme in mobile telephone|Use of Mobile phone technology in maintaining Diabetes Interactive Diary.
12014767|NCT00482443|Other|Standard Education Programme.|Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.
12014768|NCT00482430|Drug|MK0557|MK0557 10mg tablet qd for a 15-wk treatment period
12014769|NCT00482430|Drug|Comparator: Placebo (unspecified)|MK0557 Pbo tablet qd for a 15-wk treatment period
12014770|NCT00482417|Drug|MK0359|
12014771|NCT00482404|Behavioral|Romantic kissing|
12014772|NCT00482391|Biological|trastuzumab|
12014773|NCT00482391|Drug|cyclophosphamide|
12014774|NCT00482391|Drug|doxorubicin hydrochloride|
12014775|NCT00482391|Drug|lapatinib ditosylate|
12014776|NCT00482391|Drug|paclitaxel|
12014777|NCT00482391|Other|laboratory biomarker analysis|
12014778|NCT00482378|Drug|Pamidronate|90 mg by IV monthly.
12014779|NCT00482378|Drug|Zoledronic acid|4 mg by IV monthly.
12014780|NCT00482378|Radiation|Sm 153 lexidronam|0.5 mCi/kg or 1 mCi/kg by IV.
12014781|NCT00482365|Other|biologic sample preservation procedure|biologic sample preservation procedure
12014782|NCT00482365|Other|medical chart review|review of patients' medical records at study entry and every 6 months
12014783|NCT00482365|Other|Patient interview|Elicit demographic data as well as information about personal habits such as drinking and smoking.
12014784|NCT00482352|Other|laboratory biomarker analysis|Correlative studies
12014785|NCT00482313|Drug|PR OROS Methylphenidate|PR OROS Methylphenidate given orally once daily for 5 weeks. The dosage was as follows: 36 mg per day from day 1-3, 54 mg per day from day 4-7 and 72 mg per day from day 8 until end of 5th week.
12014786|NCT00482313|Drug|Placebo|Sugar pill
12014787|NCT00482300|Procedure|Systematic pelvic lymphadenectomy|
12014788|NCT00482287|Drug|MTR105|Intravenous administration, dose escalating (4 arms), single dose
12014789|NCT00482274|Drug|docetaxel|Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
12014790|NCT00482261|Drug|Lenalidomide|15mg daily, days 1-21 of a 28 day cycle for 4 cycles. Patients who get stable disease or better will then receive 15mg on days 1-21 from cycle 5 onwards
12014791|NCT00482261|Drug|dexamethasone|20mg day 1-4, 9-12, 17-20 for 4 cycles. Patients who get stable disease or better will then get dexamethasone 20mg on days 1-4 of a 28 day cycle, from cycle 5 onwards
12014792|NCT00482261|Drug|aspirin|100mg/day
12014793|NCT00482248|Drug|Omalizumab|
12014794|NCT00482235|Drug|MK0359|
12014795|NCT00482222|Biological|cetuximab|
12014796|NCT00482222|Drug|capecitabine|
12014797|NCT00482222|Drug|fluorouracil|
12014798|NCT00482222|Drug|leucovorin calcium|
12014800|NCT00482222|Other|study of socioeconomic and demographic variables|
12014801|NCT00482222|Procedure|adjuvant therapy|
12014802|NCT00482222|Procedure|neoadjuvant therapy|
12014803|NCT00482222|Procedure|quality-of-life assessment|
12014804|NCT00482209|Drug|Mifepristone, misoprostol|200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
12014805|NCT00482209|Drug|mifepristone, misoprostol|200mg mifepristone followed by 800mcg misoprostol 36-48 hours later
12014806|NCT00482196|Drug|MK0493|
12014807|NCT00482183|Drug|Pioglitazone|
12014808|NCT00482170|Device|Enbrel (etanercept)|Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
12014809|NCT00482170|Device|Etanercept|Arm 2 = Enbrel 50 mg Autoinjector twice weekly
12014810|NCT00482157|Drug|Vitamin D (Calcitriol)|
12014811|NCT00482144|Procedure|PDL 450 microseconds|The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 450 microseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.
12014812|NCT00482144|Procedure|PDL 1.5 milliseconds|The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 1.5 milliseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.
12014813|NCT00482105|Other|EGIR Tape|Tape stripping is a non-invasive method that allows the recovery of cells
12014814|NCT00482092|Drug|adult human mesenchymal stem cells|Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.
12014815|NCT00482092|Drug|Placebo|Placebo
12014816|NCT00482079|Drug|MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks|
12014817|NCT00482079|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks|
12014818|NCT00482066|Drug|Abatacept (Orencia)|"500mg for patients under 60kg 750mg for patients 60-100kg
~1g for patients>100kg given as i.v. infusion over 30 minutes at day 0, 14, 28 and then monthly for a further 11 months 914 infusions in total) placebo groups receive saline only I.v."
12014819|NCT00482053|Procedure|Autologous hematopoietic stem cell transplantation (auto-HSCT)|Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents
12014820|NCT00482053|Procedure|Allogeneic hematopoietic stem cell transplantation (allo-HSCT)|Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF)
12014821|NCT00482053|Procedure|Total lymphoid irradiation (TLI)|TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
12014822|NCT00482053|Drug|Rituximab|375 mg/m2 IV days 1 and 7 over 4 to 8 hours
12014823|NCT00482053|Drug|Carmustine|"Based on body weight, unless its more than 15 kg greater than the idal body 15mg/kg (max dose 550 mg/m2) day -6 over 2 hours.
~Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW)"
12014824|NCT00482053|Drug|Etoposide|60 mg/kg over 4 hours day -4 and alternatively VP-16 2 Gm/m² may be used (for mobilization)
12014825|NCT00482053|Drug|Filgrastim|10 µg/kg/day subcutaneous starting Day 9 until last day of apheresis. 5 ug/kg actual body weight per day will be started at Day +6 after allo-HCT until hematologic recovery
12014826|NCT00482053|Drug|Anti-thymocyte globulin (ATG)|1.5 mg/kg/day for 5 days
12014827|NCT00482053|Drug|Cyclosporine|5.0 mg/kg twice daily from day -3 until after day +56
12014828|NCT00482053|Drug|Mycophenolate mofetil (MMF)|"250 mg (total) twice daily, oral
~15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. On day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor."
12014829|NCT00482053|Drug|Cyclophosphamide|100 mg/kg will be administered over 2 hours on day -2
12014830|NCT00482053|Drug|Acetaminophen|Pre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion
12014831|NCT00482053|Drug|Diphenhydramine|Pre-medication for rituximab and PBPC infusion. Administered at 50 mg intravenous 1 hour prior to infusion
12014832|NCT00482053|Drug|Hydrocortisone|Pre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion
12014833|NCT00482053|Drug|Methylprednisolone|Anti-reaction medication for the ATG infusion. Administered at 1 mg/kg, Day-11 to Day-7
12014834|NCT00482040|Device|Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP|
12014835|NCT00482027|Biological|tgAAC09|one or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization
12014836|NCT00482014|Drug|pemetrexed|"Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles
~Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles
~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase"
12014837|NCT00482014|Drug|cisplatin|"Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43
~Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles"
12014838|NCT00482014|Drug|carboplatin|"Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min), administered intravenously, Days 1, 8, 22, 29 and 43
~Phase 2 - dosed at AUC 5 mg/mL*min, administered intravenously, every 21 days for 3 cycles"
12014839|NCT00482014|Radiation|radiation therapy|"Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51
~Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45"
12014840|NCT00482001|Drug|donepezil|
12014841|NCT00482001|Drug|Placebo (cornstarch)|
12014842|NCT00481988|Device|transcranial direct current stimulation|Two damp sponges, one placed on the left side of the forehead, the other on the left arm. 0.1mA of current is passed for 20 minutes.
12014843|NCT00481988|Device|transcranial direct current stimulation|transcranial direct current stimulation delivers one milliamp of direct current, supplied by a constant current generator, the the left dorsolateral prefrontal cortex through a scalp electrode. The treatment is given for 20 minutes a day.
12014844|NCT00481988|Device|transcranial direct current stimulation|one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode
12014845|NCT00481988|Device|iomed phoresor transcranial direct current stimulation|for the sham group the current is turned off after 10 seconds
12014846|NCT00481975|Drug|rimonabant (SR141716)|
12014847|NCT00481962|Drug|Tygacil|Initial dose of 100mg followed by 50mg every 12 hours for 5 to 14 days
12014848|NCT00481936|Drug|VB6-845|Intravenous infusion once weekly for 4 weeks
12014849|NCT00481923|Drug|rimonabant (SR141716)|
12014850|NCT00481897|Behavioral|low-fat, vegan diet|Diet that excludes animal products (i.e. meat, dairy, eggs) and keeps oils to a minimum.
12014851|NCT00481884|Other|RadiaPlexRx Gel|RadiaPlexRx Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply RadiaPlexRx gel topically 3 Times Daily to one half of the irradiated breast skin and the control, Aquaphor gel, to the other half of irradiated breast skin. This is determined through randomization process.
12014852|NCT00481884|Other|Aquaphor Gel|Aquaphor Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply Aquaphor gel topically 3 Times Daily to one half of the irradiated breast skin and the experimental, RadiaPlexRx gel, to the other half of irradiated breast skin. This is determined through randomization process.
12014853|NCT00481871|Drug|Pralatrexate Injection|"Intravenous (IV) push administration over 30 seconds to 5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).
~Sequential Dosing: 10 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.
~Same Day Dosing: 15 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."
12014854|NCT00481871|Drug|Gemcitabine Hydrochloride|"Gemcitabine will be prepared and administered as an IV infusion as per manufacturer instructions.
~Sequential Dosing: 400 mg/m2 every 2 weeks (days 2 and 16) of a 4-week cycle until criteria for discontinuation per the protocol are met.
~Same Day Dosing: 600 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."
12014855|NCT00481871|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
12014856|NCT00481871|Dietary Supplement|Folic Acid|"1 mg orally
~Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate."
12014857|NCT00481845|Drug|Vandetanib|300 mg daily
12014858|NCT00481845|Drug|Anastrozole|1 mg daily
12014859|NCT00481832|Drug|Cyclophosphamide|4 gm /m² IV over 2 hours on day 8
12014860|NCT00481832|Drug|BCNU|"The dose of BCNU will be based on actual body weight unless the actual body weight is more than 15 kg greater than the ideal body weight in which case the adjusted ideal body weight will be used:
~Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW)"
12014861|NCT00481832|Drug|Etoposide|60mg/kg, IV over 4 hours on day -4 pre-transplant and for preparative regimen. The dose of etoposide for mobilization is 2 gm/ m².
12014862|NCT00481832|Drug|Filgrastim|10µg/kg sc qd starting day following cyclosphamide (or VP-16) until last day of apheresis
12014863|NCT00481832|Drug|Antithymocyte globulin|1.5 mg/kg/d, IV from day -11 to -7
12014864|NCT00481832|Drug|Cyclosporine|5mg/kgbid,variable, po or IV
12014865|NCT00481832|Drug|Mycophenolate mofetil|15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. Thereafter, beginning on day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor. Doses will be rounded up to the nearest 250 mg (capsules are 250 mg). MMF will be stopped on day +28 for matched related donors. For one antigen mismatched related or unrelated donors, the taper will begin on day +40. MMF will be tapered by 10% weekly till off, typically by day +96. If there is nausea and vomiting at any time preventing the oral administration of MMF, MMF should be administered intravenously at an equal dose. MMF dosing is based on actual body weight.
12014866|NCT00481832|Drug|Rituximab|375 mg/m2 IV (calculated based on actual body weight) on day 1 and day 7. Administered per current standard of care..
12014867|NCT00481832|Procedure|Autologous hematopoietic stem cell transplantation (auto-HSCT)|Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents
12014868|NCT00481832|Procedure|Allogeneic hematopoietic stem cell transplantation (allo-HSCT)|Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF)
12014869|NCT00481832|Procedure|Total lymphoid irradiation|TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
12014870|NCT00481832|Drug|CD34+ Cells|2 x 10e6 CD34+ cells per kg actual body weight on Day 0
12014871|NCT00481832|Drug|Solu-Medrol|1 mg/kg, Day-11 to Day-7
12014872|NCT00481819|Drug|FK506MR|oral
12014873|NCT00481819|Drug|Prograf|oral
12014874|NCT00481819|Drug|Mycophenolate Mofetil|oral
12014875|NCT00481819|Drug|Methylprednisolone|oral
12014876|NCT00481819|Drug|Prednisolone|oral
12014877|NCT00481780|Device|plain balloon angioplasty|
12014878|NCT00481780|Device|cutting balloon angioplasty|
12014879|NCT00481767|Biological|Cervarix|The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
12014880|NCT00481767|Drug|Placebo Al(OH)3|Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
12014881|NCT00481741|Device|SafeSeal(TM) Hemostasis Patch|
12014882|NCT00481728|Drug|Tolterodine|Single dose per patient as determined by protocol.
12014883|NCT00481728|Procedure|Filling cystometry|This is a procedure.
12014884|NCT00481728|Procedure|Intravesical neurostimulation|This is a procedure.
12014885|NCT00481715|Behavioral|Web-Based Weight Loss Program|Participants will take part in a Web-based weight loss program.
12014886|NCT00481715|Behavioral|Cash Incentive Weight Loss Program|Participants will take part in a cash incentive weight loss program.
12014887|NCT00481702|Drug|Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks|
12014888|NCT00481702|Drug|MK0826, /Duration of Treatment : 8 Weeks|
12014889|NCT00481702|Drug|Comparator: metronidazole / Duration of Treatment: 8 Weeks|
12014890|NCT00481689|Drug|Cipro XR (Ciprofloxacin, BAYQ3939)|Active Ciprofloxacin XR ( 1000mg) given for 7 to 14 days
12014891|NCT00481676|Drug|Omalizumab 75-375 mg|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.
12014892|NCT00481676|Drug|Placebo to omalizumab|Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.
12014893|NCT00481676|Drug|Loratadine|All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
12014894|NCT00481676|Drug|Clemastine|All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
12014895|NCT00481663|Drug|Sitagliptin|
12014896|NCT00481663|Drug|Placebo to sitagliptin|
12014897|NCT00481663|Drug|Metformin|
12014898|NCT00481663|Drug|Rescue|Patients whose FPG >240 mg/dL from Week 16 or HbA1C >8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently >240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C >8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C >7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.
12014899|NCT00481650|Drug|Leios/Alesse|
12014900|NCT00481624|Drug|Epoetin Alfa plus Iron|"One (1) injection of Procrit®, by needle, inserted just under the skin;
~125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.
~These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.
~In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan."
12014901|NCT00481598|Procedure|magnet resonance spectroscopy|magnet resonance spectroscopy
12014902|NCT00481572|Drug|Terlipressin|continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
12014903|NCT00481572|Drug|Vasopressin|continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
12014904|NCT00481572|Drug|Norepinephrine|titrated norepinephrine over a period of 48 hrs
12014905|NCT00481559|Drug|Voraxaze (glucarpidase)|50 Units/kg in a bolus intravenous injection over 5 minutes
12014906|NCT00481546|Genetic|rAAV2-CBSB-hRPE65|One or two, uniocular, subretinal injections; relative doses: 0.3X (Cohort 1), 0.6X (Cohort 2), 0.45X (Cohort 3), 0.9X (Cohorts 4 and 5)
12014907|NCT00481533|Drug|Methyl-Ergonovine-Oxytocin|
12014908|NCT00481533|Drug|Oxytocin|
12014909|NCT00481520|Drug|SAM-531|
12014910|NCT00481520|Other|placebo|
12014911|NCT00481507|Other|Kefir|The intervention was Kefir,a drink that is commercially available in the United States. The following probiotics are present in the Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150mL) everyday.
12014912|NCT00481507|Other|Placebo|The intervention was Kefir, a drink that is commercially available in the United States. The following probiotics are present in active Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. The placebo group was heat-treated to kill all cultures. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150 mL)everyday.
12014913|NCT00481481|Drug|tacrolimus|immunosuppression
12014914|NCT00481455|Drug|Panzem NCD|2000 mg q8h, continuous dosing in 28 day cycles
12014915|NCT00481455|Drug|Temozolomide|Fixed dose
12014916|NCT00481442|Drug|Phenylephrine|
12014917|NCT00481429|Drug|Rosiglitazone|Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.
12014918|NCT00481416|Device|PillCam Eso|
12014919|NCT00481403|Behavioral|Microarray analysis|Microarray analysis
12014920|NCT00481403|Behavioral|Microarray|Microarray
12014921|NCT00481390|Procedure|Cheek cells sample|Cheek cells sample
12014922|NCT00481390|Procedure|Blood sample|Blood sample
12014923|NCT00481377|Procedure|ablation|
12014924|NCT00481364|Drug|atorvastatin|atorvastatin 40 mg/day
12014925|NCT00481364|Drug|placebo|1 tb/day
12014926|NCT00481351|Drug|Simvastatin 20mg plus ezetimibe 10mg|simvastatin 20mg plus ezetimibe 10mg once a day for 6 week.
12014927|NCT00481351|Drug|ezetimibe|ezetimiba 10mg once a day
12014928|NCT00481351|Drug|simvastatin 20mg|simvastatin 20mg once a day
12014929|NCT00481351|Drug|Simvastatin 80mg|simvastatin 20mg for 6week and then simvastatin 80mg for the next 6week.
12014930|NCT00481338|Procedure|X-rays|X-rays (hip and knee) every 2 years
12014931|NCT00481338|Biological|biological samples|biological sample (blood and urine) every 2 years
12015045|NCT00480441|Behavioral|BRENDA therapy|weekly therapy sessions for 6 weeks
12014932|NCT00481338|Other|medical information about osteoarthritis|several questionnaires about pain and function (WOMAC), physical activity (MAQ), quality of life (generic SF-36 and OA specific OAKHQOL/AMIQUAL), comorbidities (FCI), mental status (MMS), heath status (GHQ 28) and health resource consumption
12014933|NCT00481325|Drug|pexacerfont|Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
12014934|NCT00481325|Drug|escitalopram|Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
12014935|NCT00481325|Drug|placebo|Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
12014936|NCT00481312|Drug|Dexmedetomidine|Continuous Infusion
12014937|NCT00481312|Drug|Midazolam|Continuous Infusion
12014938|NCT00481286|Behavioral|Improving outcomes using group clinics for older patients|Collaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes.
12014939|NCT00481286|Behavioral|Standard of Care|Standard of care for diabetes patients
12014940|NCT00481273|Drug|Azacitidine|Physician's discretion
12014941|NCT00481260|Procedure|Medical history and basic laboratory analysis|Medical history and basic laboratory analysis
12014942|NCT00481247|Drug|Dasatinib|Tablets, oral, dasatinib 50-140 mg once daily (QD)
12014943|NCT00481247|Drug|Imatinib|Tablets, oral, imatinib 200-800 mg, QD
12014944|NCT00481234|Device|Heart Rate Variability analysis|
12014945|NCT00481221|Procedure|Observation of results from laboratory tests|Laboratory data summary only
12014946|NCT00481195|Drug|Armodafinil|Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
12014947|NCT00481195|Drug|Placebo|Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
12014948|NCT00481182|Drug|fosamprenavir + ritonavir + methadone|
12014949|NCT00481169|Drug|Bazedoxifene Acetate (TSE-424)|
12014950|NCT00481156|Behavioral|Cognitive Remediation|
12014951|NCT00481156|Behavioral|Cognitive Behavioral Social Skills Training|
12014952|NCT00481156|Other|Retest in Health Controls|Pre/Post test performance and neuroimaging only
12014953|NCT00481143|Drug|ICL670/Deferasirox|
12014954|NCT00481117|Drug|LY2405319|
12014955|NCT00481117|Drug|Placebo|
12014956|NCT00481104|Drug|Tesofensine|
12014957|NCT00481091|Drug|ABT-263|Tablet; Oral
12014958|NCT00481078|Drug|vorinostat|Given PO
12014959|NCT00481078|Drug|paclitaxel|Given IV
12014960|NCT00481078|Drug|carboplatin|Given IV
12014961|NCT00481078|Other|placebo|Given PO
12014962|NCT00481078|Other|laboratory biomarker analysis|Correlative studies
12014963|NCT00481065|Biological|MF59-eH5N1|
12014964|NCT00481065|Biological|eTIV_a|
12014965|NCT00481065|Biological|MF59-eH5N1 + eTIV_a|
12014966|NCT00481052|Drug|Nilotinib|
12014967|NCT00481039|Procedure|Medical history and basic laboratory analysis|Medical history and basic laboratory analysis
12014968|NCT00481026|Device|transcranial direct current stimulation (tDCS)|tDCS
12014969|NCT00481026|Device|active tDCS|Active tDCS
12014970|NCT00481013|Drug|Valproic Acid (VPA)|Drug: Valproic Acid and Levocarnitine; capsules
12014971|NCT00481013|Drug|Placebo|For six months, pts are randomized into placebo or treatment. After 6 months, all pts are on treatment
12014972|NCT00481000|Behavioral|Dialectical Cognitive Therapy|Dialectical Behavior Therapy in Combination with Traumafocused CBT
12014973|NCT00480987|Drug|Oxaliplatin|30 mg/m^2 IV days 1-4
12014974|NCT00480987|Drug|Fludarabine|30 mg/m^2 IV days 2-6
12014975|NCT00480987|Drug|Cytarabine|500 mg/m^2 by IV continuous infusion days 2-6
12014976|NCT00480974|Other|Clinical follow up and laboratory analysis|Clinical follow up and laboratory analysis
12014977|NCT00480961|Procedure|intramiocardiac autograft of autologous stem cells|
12014978|NCT00480948|Behavioral|Infant formula feeding (InFat™)|Infant formula with InFat™ oil (containing ~49% of C16:0 at sn-2 position), 24 wk
12014979|NCT00480948|Dietary Supplement|Control|Standard vegetable oil based infant formula
12014980|NCT00480935|Drug|Sunitinib Malate (Sutent)|Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week washout period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period.
12014981|NCT00480922|Behavioral|Low glycemic load diet|Outpatient behavioral counseling
12014982|NCT00480922|Behavioral|Low fat diet|Outpatient behavioral counseling
12014983|NCT00480896|Drug|tacrolimus ointment|Topical application
12014984|NCT00480896|Drug|Placebo ointment|Topical application
12014985|NCT00480883|Drug|meglumine antimoniate, allopurinol|first drug in injectable, second is in tablet form.
12014986|NCT00480883|Drug|meglumine antimoniate|injectable 20 mg/kg/day/intramuscular for 21 days.
12015046|NCT00480441|Drug|Placebo|4 capsules daily for 2 weeks followed by a 1 week taper
12014987|NCT00480883|Drug|meglumine antimoniate, allopurinol|injectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days.
12014988|NCT00480870|Drug|donepezil|donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.
12014989|NCT00480870|Drug|Placebo|Placebo 1p / day for 1 month and 2 / day for 5 months on
12014990|NCT00480857|Drug|Docetaxel (Taxotere)|Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
12014991|NCT00480844|Drug|Sertindole|Oral (tablets), 16-24 mg QD (once a day) for 12 weeks.
12014992|NCT00480844|Drug|Risperidone|Oral (tablets), 4-8 mg QD (once a day) for 12 weeks.
12014993|NCT00480831|Drug|bevacizumab|Intravenous repeating dose
12014994|NCT00480831|Drug|carboplatin|Intravenous repeating dose
12014995|NCT00480831|Drug|paclitaxel|Intravenous repeating dose
12014996|NCT00480831|Drug|placebo|Intravenous repeating dose
12014997|NCT00480831|Drug|PRO95780|Intravenous repeating dose
12014998|NCT00480818|Drug|SAM-531|
12014999|NCT00480805|Drug|MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks|
12015000|NCT00480805|Drug|Comparator : ramipril /Duration of Treatment : 8 Weeks|
12015001|NCT00480792|Biological|GenHevac B Pasteur|Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
12015002|NCT00480792|Biological|GenHevac B Pasteur|Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
12015003|NCT00480792|Biological|GenHevac B Pasteur|GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
12015004|NCT00480779|Behavioral|GLB Group|The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
12015005|NCT00480779|Behavioral|GLB DVD|The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and weekly telephone contact with a trained lifestyle coach.
12015006|NCT00480766|Drug|MK0217/Duration of Treatment : 12 Months|
12015007|NCT00480753|Drug|Nitroglycerin|
12015008|NCT00480740|Drug|Dexmedetomidine|Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
12015009|NCT00480727|Procedure|Halo pin re-tensioning|Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
12015010|NCT00480727|Procedure|Placebo Re-tensioning|Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.
12015011|NCT00480714|Biological|BCG (SSI Strain)|
12015012|NCT00480701|Drug|[123I]-IBVM|Subjects will be asked to undergo an injection of 123-I IBVM followed by up to three approximately thirty minute SPECT scans during the next 24 hours.
12015013|NCT00480688|Biological|BCG|
12015014|NCT00480675|Procedure|trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine|Depomedrol 60 mg + bupivacaine 2.5 ml
12015015|NCT00480675|Procedure|Trochanteric bursa injection with depomedrol and bupivacaine|Trochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance.
12015016|NCT00480662|Drug|alendronate|Duration of Treatment : 6 Months
12015017|NCT00480649|Drug|Salmeterol/ fluticasone propionate|2 active arms (parellel group)
12015018|NCT00480636|Drug|Fragmin (dalteparin sodium )|Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.
12015019|NCT00480623|Drug|Satraplatin plus radiation therapy|
12015020|NCT00480610|Drug|tacrolimus ointment|Topical application
12015021|NCT00480610|Drug|Placebo ointment|Topical application
12015022|NCT00480597|Drug|gemcitabine|
12015023|NCT00480597|Drug|cisplatin|
12015024|NCT00480597|Drug|vinorelbine|
12015025|NCT00480597|Drug|capecitabine|
12015026|NCT00480584|Drug|gemcitabine|Levels 1 through 4: 1000 mg/m^2
12015027|NCT00480584|Drug|capecitabine|Level 1: 500 mg/m^2; Level 2: 825 mg/m^2; Level 3: 1000 mg/m^2; Level 4: 1250 mg/m^2
12015028|NCT00480584|Drug|erlotinib|Levels 1 through 4: 100 mg
12015029|NCT00480571|Drug|BL-1020|BL-1020 Low Dose
12015030|NCT00480571|Drug|BL 1020 High Dose|BL 1020 High Dose
12015031|NCT00480558|Biological|MVA 85A|Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
12015032|NCT00480532|Drug|Lybrel|All women enrolled in the study will take the same daily low dose oral contraceptive (20-mcg EE/90 mcg LNG) dosed in a continuous fashion.
12015033|NCT00480532|Drug|Doxycycline|100 mg orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of doxycycline.
12015034|NCT00480532|Drug|Oracea|40-mg tablet daily for 84 days
12015035|NCT00480532|Drug|Placebo|Placebo pill orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of placebo
12015036|NCT00480532|Drug|Doxycycline 100bid x5 days at the time of bleeding|Doxycycline 100 mg orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of doxycycline
12015037|NCT00480532|Drug|Subantimicrobial doxycycline daily|Subantimicrobial dose doxycycline 40mg daily for the first 84 days of the study
12015038|NCT00480532|Drug|placebo daily|Placebo daily for the first 84 days of the study
12015039|NCT00480519|Procedure|Meatotomy|
12015040|NCT00480493|Behavioral|STEP|Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions
12015041|NCT00480480|Behavioral|Trauma and Grief Component Therapy for Adolescents (Group Version)|
12015042|NCT00480467|Drug|SAM-315|
12015043|NCT00480454|Biological|MVA 85A|intradermal vaccine
12015044|NCT00480441|Drug|Dronabinol|10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week
12015047|NCT00480402|Drug|200 mg of Progesterone|Administration of 200 mg of Progesterone
12015048|NCT00480402|Drug|400 mg Progesterone|Administration of 400 mg Progesterone
12015049|NCT00480402|Drug|Placebo|Administration of a Placebo
12015050|NCT00480389|Drug|Sorafenib|Starting dose: 400 mg (2x200mg tablets) BID (total= 800mg/day) taken orally. The dose can be adjusted as per investigator if required due to toxicity (ex. 200mg BID, 200mg QD). Study drug is taken for 12 weeks preoperatively. Patients restart on study drug 6 weeks postoperatively and continue until progression or unacceptable toxicity occurs.
12015051|NCT00480376|Drug|ofloxacin|
12015052|NCT00480376|Drug|gentamicin|
12015053|NCT00480363|Procedure|Maintenance with lower doses of lenalidomide and dexamethasone|After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance
12015054|NCT00480350|Behavioral|rice based food supplement|
12015055|NCT00480337|Procedure|In Vitro Maturation of immature oocytes|
12015056|NCT00480324|Biological|Rotarix|Two-dose oral vaccination.
12015057|NCT00480324|Biological|Placebo|Two-dose oral administration.
12015058|NCT00480311|Other|WHODAS II (World Health Organization Disability Assessment Schedule II)|To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).
12015059|NCT00480298|Drug|Administration of oral methylprednisolone|
12015060|NCT00480285|Procedure|Laparoscopic Nissen Fundoplication|
12015061|NCT00480285|Procedure|Laparoscopic anterior partial fundoplication|
12015062|NCT00480272|Drug|adalimumab, plus prednisone|adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo or prednisone 50 mg/po day then reduced to 6.25/po day
12015063|NCT00480272|Drug|adalimumab plus placebo|adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months
12015064|NCT00480259|Behavioral|hyperproteic nutrition|
12015065|NCT00480246|Drug|BL 1020|
12015066|NCT00480246|Drug|Perphenazine|
12015067|NCT00480220|Procedure|Global care and support program|
12015068|NCT00480207|Dietary Supplement|folic acid|
12015069|NCT00480207|Dietary Supplement|omega-3|
12015070|NCT00480207|Dietary Supplement|vit B12|
12015071|NCT00480207|Other|folic acid placebo|
12015072|NCT00480207|Other|omega-3 placebo|
12015073|NCT00480194|Drug|xylometazoline hydrochloride and ipratropium bromide (ZyComb)|Common cold in a real-life OTC setting
12015074|NCT00480181|Drug|nabilone|Cesamet (nabilone) capsules given at titrating dosages as per protocol.
12015075|NCT00480181|Other|placebo|placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.
12015076|NCT00480155|Biological|Frozen FluMist®|Monovalent vaccine is supplied in intranasal sprayers containing 0.5 mL.
12015077|NCT00480155|Other|Placebo|
12015078|NCT00480142|Drug|Oxycodone 10 mg|
12015079|NCT00480129|Behavioral|Probiotic or placebo yogurt consumed daily|
12015080|NCT00480129|Device|Mini Rhinoconjunctivitis Quality of Life Questionnaire|
12015081|NCT00480129|Procedure|Blood sample|
12015082|NCT00480129|Procedure|Nasal lavage|
12015083|NCT00480116|Biological|Adjuvanted Hepatitis B vaccine Lot 1|20 µg, IM, month 0 and 1
12015084|NCT00480116|Biological|Adjuvanted Hepatitis B vaccine Lot 2|20µg, IM, month 0 and 1
12015085|NCT00480116|Biological|Adjuvanted Hep B vaccine Lot 3|20µg, IM, month 0 and 1
12015086|NCT00480103|Device|in vivo (ANECOVA D-1) or in vitro culture in 25-µl droplets of cleavage medium (Medicult®) under paraffin oil|
12015087|NCT00480090|Drug|Cytarabine|Initially given at 1g/m2 bid for 2 days every 3 weeks over 2 hours. The dose will be escalated: level 1 - 1.25g/m2, level 2, 1.5g/m2.
12015088|NCT00480077|Device|Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )|OptiVol® Fluid status Monitoring with Cardiac Compass
12015089|NCT00480064|Drug|Lomustine, intermediate dose cytarabine|
12015090|NCT00480051|Device|Cardiac Resynchronization Pacing|
12015091|NCT00480038|Other|WHODAS II|To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
12015092|NCT00480025|Biological|GSK1572932A Antigen-Specific Cancer Immunotherapeutic|Intramuscular administration, 13 doses
12015093|NCT00480025|Biological|Placebo Control|Intramuscular administration, 13 doses
12015094|NCT00480012|Device|rTMS|repetitive transcranial meagnetic stimulation of the brain
12015095|NCT00479999|Drug|VRC-HIVADV027-00-VP|
12015096|NCT00479999|Drug|VRC-HIVADV038-00-VP|
12015097|NCT00479986|Drug|pioglitazone|
12015098|NCT00479986|Drug|placebo|
12015099|NCT00479973|Dietary Supplement|Cinnamonforce|"Cinnamonforce™ is a proprietary blend of Cinnamomum aromaticum and Cinnamomum verum bark containing 47 mg of hydroethanolic extract (min. 8% total phenolics) and 23 mg supercritical extract (min. 35% cinnamaldehyde) per capsule.
~2 capsules after the two largest meals of the day"
12015100|NCT00479973|Dietary Supplement|Placebo|Placebo. 2 capsules after the two largest meals of the day
12015101|NCT00479960|Behavioral|commercially available omega-3 fatty acids supplementation|
12015102|NCT00479947|Drug|Probiotics (Natural product)|
12015103|NCT00479947|Drug|Probiotics (L. rhamnosus GR-1 and L. reuteri RC-14)|
12015104|NCT00479934|Drug|imatinib mesylate|6 month treatment with 400mg/day (per os)
12015105|NCT00479921|Biological|Trivalent influenza subunit vaccine|
12015106|NCT00479908|Drug|Sildenafil citrate|
12015107|NCT00479908|Drug|Glyceryl trinitrate|
12015108|NCT00479895|Drug|Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)|Pre-oxygenated HBOC-201
12015109|NCT00479882|Drug|Comparator: simvastatin|
12015110|NCT00479882|Drug|MK-0524A|Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
12015111|NCT00479882|Drug|Placebo|
12015112|NCT00479882|Drug|MK-0524B|
12015113|NCT00479856|Drug|Lapatinib|Small molecule tyrosine kinase inhibitor
12015114|NCT00479856|Drug|Capecitabine|Chemotherapy
12015115|NCT00479856|Drug|Docetaxel|Chemotherapy
12015116|NCT00479856|Drug|nab-Paclitaxel|Chemotherapy
12015117|NCT00479843|Behavioral|Nutritional programme|
12015175|NCT00479427|Drug|GW842166|100 mg once daily
12015118|NCT00479830|Behavioral|Focus Groups|Eight Focus Groups Consisting of 8-10 Members Each
12015119|NCT00479830|Behavioral|Questionnaire|To collect data to assess the unmet health and cancer needs of the South Asian population in the Greater Houston area and to determine barriers and other factors that affect health in this population.
12015120|NCT00479830|Behavioral|Interview|To collect data to assess the unmet health and cancer needs of the South Asian population in the Greater Houston area and to determine barriers and other factors that affect health in this population.
12015121|NCT00479817|Drug|AMG 386|10mg/kg
12015122|NCT00479817|Drug|AMG 386|3 mg/kg
12015123|NCT00479817|Drug|Paclitaxel|Paclitaxel 80 mg/m2 IV QW (3 on/1 off)
12015124|NCT00479817|Drug|AMG 386 Placebo|AMG 386 Placebo
12015125|NCT00479804|Device|inertgas rebreathing|determination of cardiac output by inertgas rebreathing
12015126|NCT00479804|Device|spirometry|spirometry for testing the ventilatory function
12015127|NCT00479804|Device|cardiac magnetic resonance imaging (CMR)|CMR examination which delivers the hemodynamic reference parameters
12015128|NCT00479791|Behavioral|Test meals rich in different fatty acids|
12015129|NCT00479778|Drug|Bazedoxifene/conjugated estrogens|
12015130|NCT00479765|Drug|OncoGel (ReGel/Paclitaxel)|OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
12015131|NCT00479752|Drug|FOLFOX4 (Oxaliplatin), Cetuximab|"Arm A FOLFOX4:
~Oxaliplatin 85 mg/m² d1
~Leucovorin 200 mg/m² d1+d2, followed by
~Bolus 5FU 400 mg/m², followed by
~Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks
~Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m².
~Arm B FOLFOX4:
~Oxaliplatin 85 mg/m² d1
~Leucovorin 200 mg/m² d1+d2, followed by
~Bolus 5FU 400 mg/m² , followed by
~Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks
~Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks."
12015132|NCT00479739|Drug|Salmeterol/fluticasone propionate or formoterol/budesonide|
12015133|NCT00479726|Drug|duloxetine hydrochloride|
12015134|NCT00479713|Drug|ezetimibe (+) simvastatin|ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
12015135|NCT00479713|Drug|Comparator : rosuvastatin calcium|rosuvastatin 10mg. The treatment duration will be 6 weeks.
12015136|NCT00479713|Drug|Comparator: Placebo (unspecified)|rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
12015137|NCT00479713|Drug|Comparator: Placebo (unspecified)|ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
12015138|NCT00479700|Drug|SAM-531|
12015139|NCT00479687|Device|SUPARTZ|Supartz injection into the glenohumeral joint space.
12015140|NCT00479687|Device|Phosphate Buffered Saline|Saline injection into the glenohumeral joint space.
12015141|NCT00479674|Drug|Abraxane|100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
12015142|NCT00479674|Drug|Bevacizumab|10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
12015143|NCT00479674|Drug|Carboplatin|area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
12015144|NCT00479661|Drug|Dexmedetomidine|Continuous infusion
12015145|NCT00479661|Drug|Propofol|Continuous infusion
12015146|NCT00479648|Biological|CSL412|
12015147|NCT00479648|Biological|Inactivated trivalent influenza vaccine|
12015148|NCT00479635|Drug|TPI 287|160 mg/m2 every three weeks for six cycles
12015149|NCT00479635|Drug|TPI 287|160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease.
12015150|NCT00479622|Drug|TRU-015|Arm 1 = 800 mg Arm 2 = 2000 mg
12015151|NCT00479609|Drug|Transdermal testosterone therapy|testosterone 1% hydroalcohol gel
12015152|NCT00479609|Drug|Placebo|Placebo gel
12015153|NCT00479596|Drug|Botox|
12015154|NCT00479583|Drug|BMS-690514 / FOLFIRI|Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
12015155|NCT00479583|Drug|BMS-690514 / FOLFOX|Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
12015156|NCT00479570|Drug|PF-00446687|Single 200mg dose
12015157|NCT00479570|Drug|Placebo|
12015158|NCT00479557|Biological|ACC-001 + QS-21|Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
12015159|NCT00479557|Biological|ACC-001|Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
12015160|NCT00479557|Biological|QS-21|QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
12015161|NCT00479557|Drug|Placebo: Phosphate buffered saline|Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
12015162|NCT00479531|Device|AirCast Sequential Compression Device|
12015163|NCT00479505|Drug|UK-369,003|UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
12015164|NCT00479505|Drug|Placebo|Placebo
12015165|NCT00479492|Drug|CP-866,087|1 mg of CP-866,087, administered QD for 84 days
12015166|NCT00479492|Drug|CP-866,087|5 mg of CP-866,087, administered QD for 84 days
12015167|NCT00479492|Drug|CP-866,087|10 mg of CP-866,087, administered QD for 84 days
12015168|NCT00479492|Drug|placebo|placebo administered QD for 84 days
12015169|NCT00479479|Drug|Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)|an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
12015170|NCT00479466|Drug|MK0893|MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
12015171|NCT00479466|Drug|Metformin|Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
12015172|NCT00479466|Drug|Placebo to MK0893|Dose-matched placebo tablets to MK0893; taken orally once daily.
12015173|NCT00479466|Drug|Placebo to Metformin|Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
12015174|NCT00479440|Drug|SAM-315|
12015177|NCT00479401|Drug|Pramipexol Extended Release|
12015178|NCT00479401|Drug|Pramipexol Immediate Release|
12015179|NCT00479401|Drug|Placebo|
12015180|NCT00479388|Drug|Comparator: simvastatin|simvastatin (20mg to 40mg) for 12 weeks.
12015181|NCT00479388|Drug|niacin (+) laropiprant|One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
12015182|NCT00479388|Drug|Comparator: atorvastatin calcium|atorvastatin calcium (20mg to 40mg) for 12 weeks.
12015183|NCT00479375|Procedure|Adding Human Papillomavirus testing to organised cervical screening|
12015184|NCT00479362|Drug|Warfarin|Warfarin is either interrupted or uninterrupted prior to device implantation
12015185|NCT00479362|Drug|Aspirin|Aspirin is continued without interruption prior to device implantation
12015186|NCT00479362|Device|Permanent pacemaker|Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
12015187|NCT00479362|Device|Implantable Cardioverter-defibrillator|Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
12015188|NCT00479349|Drug|SAM-531|Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.
12015189|NCT00479336|Drug|OPC-41061 7.5mg|7.5mg, 1 tablet a day
12015190|NCT00479336|Drug|OPC-41061 placebo|placebo, 1 tablet a day
12015191|NCT00479336|Drug|OPC-41061 15mg|15mg, 1 tablet a day
12015192|NCT00479336|Drug|OPC-41601 30mg|30mg, 1 tablet a day
12015193|NCT00479323|Biological|Pneumovax 23|Licensed pneumococcal vaccine (Pneumovax 23).
12015194|NCT00479310|Drug|Summers 5% L.A.|
12015195|NCT00479297|Drug|SAM-531|
12015196|NCT00479284|Procedure|Average volume assured pressure support (AVAPS)|
12015197|NCT00479271|Behavioral|Home based, flexible, stepped care intervention|Home based, flexible, stepped care intervention
12015198|NCT00479271|Behavioral|Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.|Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.
12015199|NCT00479258|Drug|Inhaled insulin (Exubera)|Inhaled insulin with dose adjusted according to premeal blood glucose
12015200|NCT00479258|Drug|Subcutaneous Insulin (subject's prescribed)|Subcutaneous insulin with dose adjusted according to premeal blood glucose
12015201|NCT00479245|Other|Set of questionnaires (respondent)|To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
12015202|NCT00479232|Drug|vorinostat|
12015203|NCT00479232|Drug|decitabine|
12015204|NCT00479219|Drug|GSI-953|
12015205|NCT00479219|Other|Placebo|
12015206|NCT00479206|Drug|Artesunate|
12015207|NCT00479193|Drug|bacitracin/xeroform|single layer, change every 3 days
12015208|NCT00479193|Drug|Polymem|single layer of Polymen, change every 3 days
12015209|NCT00479180|Biological|Vascugel|One time implant on the day of surgery
12015210|NCT00479180|Biological|Placebo Comparator|One time implant on the day of surgery
12015211|NCT00479167|Drug|Bortezomib and Tositumomab I-131|
12015212|NCT00479154|Drug|Botulinum Toxin A|Maximum dose of 90 units/leg was injected.
12015213|NCT00479141|Behavioral|HIV skills training|Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15
12015214|NCT00479141|Behavioral|Popular Opinion Leaders training|Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.
12015215|NCT00479128|Drug|Bortezomib|Starting dose: 0.8 mg/m^2 IV Over 3-5 Seconds
12015216|NCT00479128|Drug|Gemcitabine|Starting dose: 225 mg/m^2 IV Up to 90 Minutes
12015217|NCT00479128|Drug|Doxorubicin|Starting dose: 12.5 mg/m^2 IV Over 15-30 minutes
12015218|NCT00479115|Drug|AMD3100|240 mcg/kg subcutaneously, minimum of two days; maximum of eight days
12015219|NCT00479115|Device|AmCell CliniMACs|CD34+ cell selection from peripheral collection
12015220|NCT00479102|Drug|Ferripel-3 - iron polysaccharide complex for prevention|
12015221|NCT00479089|Drug|Docetaxel|25 mg/m2 IV over 30 minutes for 4 weeks, followed by 2 weeks off therapy.
12015222|NCT00479089|Drug|ZD1839|250 mg by mouth daily, without break.
12015223|NCT00479089|Drug|Dexamethasone|"Course #1: 3 doses of prophylactic Dexamethasone 4mg orally every 12 hours, starting the night before the Docetaxel infusion.
~Course #2: If no hypersensitivity reactions and no significant fluid retention during course 1, the Dexamethasone is reduced to 4mg orally twice daily on the day of therapy.
~Course #3 and subsequent courses: If no hypersensitivity reactions and no significant fluid retention during course 2, the Dexamethasone is reduced to 4mg orally one hour before treatment."
12015224|NCT00479076|Drug|aflibercept (AVE0005)|intravenous infusion
12015225|NCT00479076|Drug|S-1|oral administration
12015226|NCT00479050|Procedure|chemoembolization ,Radiofrequency ablation|
12015227|NCT00479037|Drug|Full Length Parathyroid Hormone, PTH(1-84)|Once daily subcutaneous injection in the abdomen by self administration
12015228|NCT00479037|Drug|Strontium Ranelate|The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water
12015229|NCT00479024|Drug|iodinated contrast agent|iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque
12015230|NCT00479011|Procedure|fluid management based on arterial pulse pressure variation|
12015231|NCT00478998|Drug|Tamsulosin|
12015232|NCT00478985|Behavioral|Imatinib ending|Interruption of the treatment by Imatinib
12015233|NCT00478972|Drug|Rimonabant|Tablet, oral administration
12015234|NCT00478972|Drug|placebo (for Rimonabant)|Tablet, oral administration
12015235|NCT00478972|Other|Diet and exercise|Target daily caloric intake: Ideal body weight × 25 kcal
12015236|NCT00478959|Drug|Lenalidomide (Revlimid®)|25mg PO daily for 21 out of 28days per cycle
12015340|NCT00478036|Drug|Pred Forte|Details covered in arm description
12015237|NCT00478946|Drug|(FOLPI) Picoplatin with 5-FU and Leucovorin|Picoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
12015238|NCT00478946|Drug|FOLPI|Picoplatin, 150 mg/m2 to be administered with every alternate cycle of 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W, will be administered as a 2-hour infusion, either alone or, if the patient is to receive picoplatin that cycle, at the same time as picoplatin, in separate bags using a Y-line. The leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
12015239|NCT00478946|Drug|FOLFOX|Oxaliplatin 85 mg/m. Leucovorin (400 mg/m2 in D5W). Oxaliplatin and leucovorin Leucovorin + oxaliplatin 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion.
12015240|NCT00478933|Device|Defibrillator, Dual Chamber ; Implantable|Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.
12015241|NCT00478933|Procedure|Blood sampling|Blood sampling
12015242|NCT00478907|Drug|KETAMINE, PROPOFOL, THIOPENTAL|
12015243|NCT00478881|Drug|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
12015244|NCT00478881|Drug|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
12015245|NCT00478855|Drug|Tazocin (Piperacillin/Tazobactem)|
12015246|NCT00478842|Device|Deep brain stimulation|Deep brain stimulation
12015247|NCT00478816|Biological|Fluad H5N1 Pandemic Influenza Vaccine|Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm.
12015248|NCT00478803|Procedure|Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty|"Remodeling procedure associated with a subvalvular aortic ring: a) Five U stitches are placed inside out in the subvalvular plane (3 stitches 2 mm below the nadir of insertion of each cusp, 2 stitches below 2 of the 3 commissures at the base of the interleaflet triangles (no suture is placed at the base of the interleaflet triangle situated between the right and noncoronary sinuses to avoid injury of the bundle of His)); b) remodeling of the aortic root by scalloping a bulged graft (Gelweave ValsalvaTM); c) The 5 anchoring U stitches are passed through the inner aspect of the prosthetic aortic ring and tied down externally in the subvalvular position; d) anastomosis of the coronary ostia and to distal ascending aorta."
12015249|NCT00478803|Device|Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots|Expansible Prosthetic Aortic Ring: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots
12015250|NCT00478790|Device|ologen™ Collagen matrix implantation in glaucoma filtering surgery|ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
12015251|NCT00478777|Drug|Lenalidomide|Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression.
12015252|NCT00478777|Drug|dexamethasone|Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.
12015253|NCT00478764|Drug|intraocular triamcinolone and gatifloxicin|
12015254|NCT00478738|Drug|GSK961081|
12015255|NCT00478725|Drug|GW786034, oral|oral, 800 mg
12015256|NCT00478725|Drug|GW786034, IV|IV, 5 mg
12015257|NCT00478725|Drug|GW786034, radiolabeled oral|oral, 400 mg radiolabeled
12015258|NCT00478712|Other|Identification of genetic causes of Hirschsprung Disease|Blood, saliva, or DNA samples are requested from all study participants. The blood or saliva samples are used to isolate DNA in all participants. Blood samples are also used to establish cell lines in some participants.
12015259|NCT00478699|Drug|Docetaxel/Cisplatin|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
12015260|NCT00478699|Drug|Docetaxel|Docetaxel 75 mg/m2 day 1, 4 cycles
12015261|NCT00478699|Drug|Gemcitabine/Cisplatin|Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
12015262|NCT00478699|Drug|Docetaxel/Cisplatin|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
12015263|NCT00478686|Procedure|Phlebotomy|5 to 7.5 milliliter (mL) Blood Sample
12015264|NCT00478673|Device|NexStent Carotid Stent System (Monorail Delivery System)|Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
12015265|NCT00478673|Device|FilterWire EZ™ Embolic Protection System|Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
12015266|NCT00478660|Drug|adalimumab (Humira)|
12015267|NCT00478647|Biological|GA-GCB (velaglucerase alfa)|15-60 U/kg, every other week via intravenous infusion
12015268|NCT00478634|Drug|RAD001, Cetuximab, Irinotecan|
12015269|NCT00478621|Biological|GSK Biologicals' HPV vaccine (GSK1674330A)|Intramuscular administration, 5 different formulations
12015270|NCT00478621|Biological|Cervarix TM|Intramuscular administration
12015271|NCT00478608|Drug|Sirolimus (Rapamune®)|(1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.
12015272|NCT00478595|Drug|Rimonabant|Tablet, oral administration
12015273|NCT00478595|Drug|Placebo (for Rimonabant)|Tablet, oral administration
12015274|NCT00478595|Drug|Anti-diabetic monotherapy|Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period
12015275|NCT00478582|Procedure|Estimation of Hb concentrations with the HemoHue card|
12015276|NCT00478569|Drug|Parathyroid Hormone (PTH) (1-84)|Adherence to PTH(1-84) treatment in Usual Clinical Settings
12015277|NCT00478556|Drug|Omnipaque|Oral CT contrast
12015278|NCT00478556|Drug|Gastroview|Oral CT contrast
12015279|NCT00478543|Drug|Furosemide|
12015280|NCT00478530|Procedure|ELECTRORETINOGRAM|Bevacizumab 1.25 mg/0.05 ml unilaterally into the vitreous cavity as part of the standard management for choroidal neovascular AMD. ERG responses form both eyes will be measured at baseline and 1 month after intravitreal injection
12015281|NCT00478517|Drug|Erythropoetin (rHuEPO, EPREX®)|
12015282|NCT00478504|Drug|Letrozole|Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg
12015283|NCT00478504|Drug|Clomifene citrate|Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg
12015284|NCT00478478|Procedure|Mechanical Thrombectomy|Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.
12015285|NCT00478465|Drug|valganciclovir|
12015286|NCT00478452|Biological|DC-Ova|
12015287|NCT00478452|Biological|DC Ova with Cyclophosphamide|
12015288|NCT00478439|Dietary Supplement|ZeaVision EyePromise Restore|Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,
12015289|NCT00478439|Dietary Supplement|Multivitamin|Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,
12015290|NCT00478426|Drug|Sunitinib Malate|Given PO
12015291|NCT00478387|Biological|The current season's trivalent killed influenza vaccine|
12015292|NCT00478374|Drug|Sorafenib|Sorafenib 400mg bid
12015293|NCT00478374|Procedure|Transarterial chemoembolisation with doxorubicin|Transarterial chemoembolisation (TACE)
12015294|NCT00478361|Drug|Gemcitabine hydrochloride|Gemcitabine 900 mg/m^2 IV over 90 minutes repeat every 14 days.
12015295|NCT00478361|Drug|Paclitaxel|135 mg/m^2 IV over 1 hour
12015296|NCT00478361|Drug|Doxorubicin hydrochloride|Doxorubicin 40 mg/m^2 IV over 20 minutes
12015297|NCT00478361|Drug|Pegfilgrastim|Subcutaneously injection on day 1.
12015298|NCT00478348|Procedure|Prosthetic repair of abdominal incisional hernia|Rives-Stoppa repair of incisional hernia
12015299|NCT00478335|Drug|sildenafil|25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight
12015300|NCT00478335|Drug|calcitonin|one nasal spray daily for 4 days
12015301|NCT00478335|Drug|hydrochlorothiazide/amiloride|25 mg/2.5 mg BID or 50 mg/5 mg BID x 8 days depending on subject weight
12015302|NCT00478335|Drug|indomethacin|50 mg QD or 50 mg BID x 8 days depending on subject weight
12015303|NCT00478335|Drug|Placebo for sildenafil|one tablet daily for 4 days
12015304|NCT00478335|Drug|placebo for calcitonin|one nasal spray daily
12015305|NCT00478322|Drug|Placebo|Matching placebo of 100 mg BID
12015306|NCT00478322|Drug|INCB013739|INCB013739 100 mg BID
12015307|NCT00478309|Other|counseling intervention|
12015308|NCT00478309|Other|educational intervention|
12015309|NCT00478283|Other|survey administration|
12015310|NCT00478270|Drug|ibandronate [Bondronat]|6mg iv on days 1-3
12015311|NCT00478257|Device|bright white light|Intervention: Bright white light administered for 30 minutes each morning
12015312|NCT00478257|Device|comparator red light treatment|dim red light administered for 30 minutes every morning
12015313|NCT00478244|Drug|busulfan|Day -9 through Day -6: 1.1 mg/kg if < 12 kg IV every 6 hours; 0.8 mg/kg if > 12 kg.
12015314|NCT00478244|Drug|cyclophosphamide|Day -5 through Day -2: 50 mg/kg IV over 120 min.
12015315|NCT00478244|Drug|fludarabine phosphate|Day -5 through Day -3: 25 mg/m2 IV over 60 min.
12015316|NCT00478244|Procedure|hematopoietic bone marrow transplantation|allogeneic bone marrow, peripheral stem cell or umbilical cord blood transplantation
12015317|NCT00478231|Drug|Maraviroc|Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.
12015318|NCT00478218|Drug|cyclophosphamide|300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles)
12015319|NCT00478218|Drug|dexamethasone|40 mg administrated by PO (with food)on Days 1, 8, 15 & 22
12015320|NCT00478218|Drug|lenalidomide|25 mg administrated by PO (with food)on Days 1-21
12015321|NCT00478205|Drug|Aricept (donepezil SR 23 mg)|"Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:
~23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation."
12015322|NCT00478205|Drug|Aricept (donepezil IR 10 mg)|"Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:
~10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation."
12015323|NCT00478192|Drug|Conivaptan|premix bag
12015324|NCT00478192|Drug|Placebo|premix bag
12015325|NCT00478179|Drug|Transdermal/Patch (Bupivacaine TTS [Eladur™])|
12015326|NCT00478140|Biological|trastuzumab|For HER-2/neu positive biopsies, trastuzumab was administered intravenously, once every 3 weeks, at a loading first dose at 8 mg/kg over 90 minutes, and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.
12015327|NCT00478140|Other|laboratory biomarker analysis|Correlative studies
12015328|NCT00478114|Drug|sorafenib|sorafenib in the patients with advanced Renal Cell Carcinoma
12015329|NCT00478101|Drug|oxycodone fentanyl|
12015330|NCT00478088|Device|NeoDisc|The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
12015331|NCT00478088|Device|Instrumented Anterior Cervical Discectomy and Fusion (ACDF)|Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
12015332|NCT00478075|Drug|bortezomib|
12015333|NCT00478075|Other|immunologic technique|
12015334|NCT00478075|Radiation|samarium Sm 153 lexidronam pentasodium|
12015335|NCT00478062|Biological|Hodgkin's antigens-GM-CSF-expressing cell vaccine|
12015336|NCT00478062|Procedure|adjuvant therapy|
12015337|NCT00478049|Drug|Gefitinib|250 mg oral tablet
12015338|NCT00478049|Drug|Docetaxel|intravenous infusion
12015339|NCT00478036|Drug|Acular LS|Details covered in arm description
12015341|NCT00478036|Other|Refresh Tears|Placebo
12015342|NCT00478023|Drug|Morphine|20 mg IR; 4 - 6 hourly; Total 72 hours
12015343|NCT00478023|Drug|CG5503 IR|50mg; 4 - 6 hourly; Total 72 hours
12015344|NCT00478023|Drug|CG5503 IR|75mg; 4 -6 hourly; Total 72 hours
12015345|NCT00478023|Drug|CG5503 IR|100mg, 4 - 6 hourly; Total 72 hours
12015346|NCT00478023|Drug|Placebo|4 - 6 hourly; Total 72 hours
12015347|NCT00478010|Other|counseling intervention|
12015348|NCT00478010|Other|study of socioeconomic and demographic variables|
12015349|NCT00478010|Procedure|psychosocial assessment and care|
12015350|NCT00478010|Procedure|quality-of-life assessment|
12015351|NCT00477997|Device|Physiological Bolus of Growth Hormone|0,5 mg Norditropin
12015352|NCT00477984|Drug|alcohol|alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
12015353|NCT00477971|Biological|filgrastim|No administration information given
12015354|NCT00477971|Drug|dexamethasone|Given orally
12015355|NCT00477971|Drug|melphalan|Given IV or orally
12015356|NCT00477971|Procedure|autologous hematopoietic stem cell transplantation|Given on day 0
12015357|NCT00477958|Other|questionnaire administration|Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.
12015358|NCT00477958|Procedure|cognitive assessment|Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
12015359|NCT00477958|Procedure|psychosocial assessment and care|Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
12015360|NCT00477945|Drug|clofarabine|"Cohort N Clofarabine (mg/m2/day)
~3-6 30
~3-6 40
~3-6 50
~3-6 60
~6-10 70"
12015361|NCT00477906|Biological|M-Vax- autologous, hapten-modified melanoma vaccine|Autologous, DNP-modified melanoma cells in suspension Dose: 12+-8 million cells Route: intradermal Frequency: weekly X7 + 6 month booster
12015362|NCT00477893|Drug|Adalimumab|sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
12015363|NCT00477893|Drug|Placebo|sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.
12015364|NCT00477880|Biological|Cetuximab|
12015365|NCT00477867|Procedure|quality-of-life assessment|
12015366|NCT00477854|Drug|Chromium Picolinate|Test whether Chromium Picolinate supplementation affects food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later among healthy, overweight and/or obese, adult women who are determined to be carbohydrate creavers.
12015367|NCT00477841|Procedure|Esophageal stent placement|
12015368|NCT00477841|Procedure|dysphagia scores|
12015369|NCT00477841|Procedure|complications of therapy|
12015370|NCT00477841|Procedure|survival time of therapy|
12015371|NCT00477828|Device|Continuous positive airway pressure|
12015372|NCT00477815|Biological|rituximab|375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22)
12015373|NCT00477815|Drug|melphalan|100/m2 in 1000 ml 0.9% NaCI IV infusion over 1 hour daily x 2 days.
12015374|NCT00477815|Biological|Stem Cell|greater than or equal to 2 x 106 CD34+/kg by IV
12015375|NCT00477815|Biological|Sargramostim (GM-CSF)|500 mcg by Subcutaneous QD
12015376|NCT00477815|Radiation|90Y-Zevalin|Dose escalation scheme. The dose of Zevalin will be based on the calculated radiation to the liver.
12015377|NCT00477815|Biological|111In Zevalin|5.0 mCi by IV
12015378|NCT00477802|Biological|Botulinum Toxin Type A|Injected once during the course of the study.
12015379|NCT00477802|Biological|Placebo|Injected once during the course of the study.
12015380|NCT00477789|Drug|allopurinol|
12015381|NCT00477776|Drug|Metoclopramide (Maxolon)|Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, once a day for day 11 and 12
12015382|NCT00477776|Drug|Placebo|Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10, once a day from day 11 to 12
12015383|NCT00477763|Drug|Restasis, Refresh Endura|"Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
~Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening"
12015384|NCT00477750|Drug|lenalidomide|"Phase I - dose escalating: 5mg level -1, 10mg level 0, 10mg level 1, 15mg level 2, 20mg level 3, 25mg level 4, orally days 1-21 every 28 days until progression
~Phase II - 10 mg orally days 1-21 every 28 days until progression"
12015385|NCT00477750|Drug|melphalan|"Phase I - dose escalating: 5mg/m^2 dose level -1, 5 mg/m^2 dose level 0, 8 mg/m^2 dose level 1 - 4, daily x 4 orally days every 28 days until progression
~Phase II - 5mg/m^2 orally days 1-4 every 28 days until progression"
12015386|NCT00477750|Drug|prednisone|60mg/m^2, orally days 1-4 every 28 days until progression
12015387|NCT00477737|Drug|Sevoflurane|
12015388|NCT00477737|Drug|propofol|
12015389|NCT00477724|Behavioral|exercise and respiratory therapy|exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
12015390|NCT00477724|Other|sedentary control group|control group with no specific training
12015391|NCT00477711|Drug|cetuximab, cisplatin, capecitabine|Product 1: Cetuximab(Erbitux®) Dosing schedule: 400mg/m2 initial dose and then 250mg/m2 ,weekly dose Mode of administration: intravenously Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously
12015392|NCT00477685|Device|OculusGen Biodegradable Collagen Matrix Implant|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
12015393|NCT00477672|Drug|Pimavanserin tartrate (ACP-103)|10 mg, tablet, once daily by mouth, 6 weeks
12015394|NCT00477672|Drug|Pimavanserin tartrate (ACP-103)|40 mg, tablet, once daily by mouth, 6 weeks
12015395|NCT00477672|Drug|Placebo|tablet, once daily by mouth, 6 weeks
12015396|NCT00477659|Drug|donepezil HCl (Aricept)|Oral donepezil 5mg/day for 4 weeks, followed by 10 mg/day for 8 weeks
12015397|NCT00477646|Behavioral|Prevention Care Management|Telephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.
12015398|NCT00477633|Drug|Norethindrone/ethinyl estradiol|1 tablet per day
12015601|NCT00475969|Drug|duloxetine|
12015399|NCT00477620|Behavioral|Wearing of reading glasses during prolonged near work|
12015400|NCT00477607|Drug|alpha-lipoic acid|Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
12015401|NCT00477607|Behavioral|Audiology|otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
12015402|NCT00477607|Biological|laboratory biomarker analysis|Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
12015403|NCT00477607|Drug|Placebo|Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
12015404|NCT00477594|Drug|mipomersen sodium|200 mg/ml, in 1 ml solution for subcutaneous injection.
12015405|NCT00477581|Drug|exenatide|subcutaneous injection (5mcg or 10mcg), twice a day
12015406|NCT00477581|Drug|sitagliptin|oral administration (100mg), once a day in the morning
12015407|NCT00477555|Device|Aortic implantation of Mosaic Ultra porcine bioprosthesis|All patients get implanted with a Mosaic Ultra tissue valve to evaluate hemodynamic performance at 6 months post implant.
12015408|NCT00477542|Drug|clofarabine|"Cohort- n- Clofarabine (mg/m2/day)
~-1 3-10 20
~3-6 30
~3-6 40
~3-6 50
~3-6 60
~6-10 70"
12015409|NCT00477529|Drug|ABI-008|nab-docetaxel
12015410|NCT00477516|Procedure|exposure to a high-calcium dialysate bath|Subjects are exposed to a high calcium (3.5 mEq/L) dialysate bath for 150 minutes (part 1). At defined timepoints (0, 45, 90, and 150 min) blood is sampled for calcium, PTH, phosphorous, and FGF-23. At another (later) dialysis session (part 2), the process is repeated except that the subjects are exposed to a normal calcium bath (2.5 mEq/L). For each subject, results from part 1 are compared to the results from part 2.
12015411|NCT00477503|Drug|Gallium-67 Citrate (Ga-67)|"Group A: Ga-67 citrate injection alone, in the baseline study.
~Group B: Ga-67 and In 111 DTPA injection in the baseline study.
~Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study."
12015412|NCT00477503|Drug|In-111 DTPA (In-111 pentetate)|"Group B: Ga-67 and In 111 DTPA injection in the baseline study.
~Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study."
12015413|NCT00477490|Drug|desmopressin acetate|Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
12015414|NCT00477490|Drug|Placebo|Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
12015415|NCT00477477|Other|Diet|Low glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
12015416|NCT00477477|Other|Diet|Low saturated fat diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
12015417|NCT00477464|Drug|Lapatinib|1250mg once daily
12015418|NCT00477464|Drug|capecitabine|2000mg/m^2 twice daily (14 days out of 21 days)
12015419|NCT00477451|Drug|Inhaled placebo|Inhaled Staccato Alprazolam Placebo
12015420|NCT00477451|Drug|Inhaled alprazolam 1 mg|Inhaled Staccato Alprazolam 1 mg
12015421|NCT00477451|Drug|Inhaled alprazolam 2 mg|Inhaled Staccato Alprazolam 2 mg
12015422|NCT00477451|Drug|IV doxapram|0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
12015423|NCT00477412|Drug|Bortezomib|Given IV
12015424|NCT00477412|Drug|Cyclophosphamide|Given IV
12015425|NCT00477412|Drug|Cytarabine|Given IV
12015426|NCT00477412|Drug|Dexamethasone|Given PO or IV
12015427|NCT00477412|Drug|Doxorubicin|Given IV
12015428|NCT00477412|Drug|Methotrexate|Given IV
12015429|NCT00477412|Biological|Rituximab|Given IV
12015430|NCT00477412|Drug|Vincristine|Given IV
12015431|NCT00477399|Behavioral|The Evje Model|
12015432|NCT00477386|Drug|decitabine|"Decitabine dose will be escalated as follows.
~Dose level 1: 10mg/m2 IV QD X 5 days Dose level 2: 20mg/m2 IV QD X 5 days Dose level -1: Carboplatin AUC 4."
12015433|NCT00477373|Drug|depakine chrono|Depakine Chrono 500 mg
12015434|NCT00477360|Device|Humeral surface replacement hemiarthroplasty (CAP)|C.A.P hemiarthroplasty
12015435|NCT00477347|Device|Closed loop administration|intraoperative closed loop administration of propofol and remifentanil
12015436|NCT00477347|Device|Manual administration|intraoperative manual administration of propofol and remifentanil
12015437|NCT00477334|Drug|Famciclovir|oral; two 500 mg tablets twice a day; single day treatment
12015438|NCT00477334|Drug|Placebo|oral; two tablets twice a day; single day treatment
12015439|NCT00477321|Drug|CYT 107|3 dose levels: 3, 10 and 20µg/kg/week.3administrations
12015440|NCT00477308|Procedure|salvage therapy|
12015441|NCT00477295|Drug|Zonisamide|Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
12015442|NCT00477295|Drug|Carbamazepine|Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
12015443|NCT00477282|Drug|Karenitecin|Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
12015444|NCT00477282|Drug|Topotecan|Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days)
12015445|NCT00477269|Drug|Imatinib mesylate|
12015446|NCT00477269|Drug|Placebo|
12015447|NCT00477256|Behavioral|Questionnaires|5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures.
12015448|NCT00477243|Behavioral|Questionnaire|8 questionnaires will take about 40 minutes to complete.
12015449|NCT00477230|Device|Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
12015450|NCT00477230|Drug|Standard Anti-arrhythmic Drug (AAD) Therapy|Medication as prescribed by physician.
12015451|NCT00477217|Drug|Zoledronic acid|
12015452|NCT00477204|Drug|Simvastatin|simvastatin 20 mg daily
12015453|NCT00477204|Drug|Ezetimibe/Simvastatin|Ezetimibe (10mg)/Simvastatin (20mg)
12015454|NCT00477191|Drug|Etanercept|TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
12015455|NCT00477165|Drug|Citalopram|20mg/day for 4 weeks, then 40 mg/day for 4 weeks
12015456|NCT00477165|Drug|Placebo|Identical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks
12015457|NCT00477152|Drug|hyaluronidase (human recombinant)/rehydration fluid|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
12015458|NCT00477126|Drug|GPO ritonavir versus Norvir|RTV generic compared to reference drugs (Norvir, Abbott)
12015459|NCT00477100|Procedure|Biospecimen Collection|Undergo collection of blood, tissue, and stool
12015460|NCT00477100|Other|Interview|Participate in interview
12015461|NCT00477100|Other|Medical Chart Review|Undergo collection of medical data
12015462|NCT00477100|Other|Questionnaire Administration|Ancillary Studies
12015463|NCT00477087|Drug|Mitoxantrone|Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.
12015464|NCT00477087|Drug|GM-CSF|GM-CSF is a biologic response modifier, classified as a colony stimulating factor.
12015465|NCT00477074|Procedure|bronchoalveolar lavage, blood analysis|
12015466|NCT00477061|Drug|Morphine|
12015467|NCT00477048|Drug|Saquinavir|SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI
12015468|NCT00477035|Drug|CIK cells|2x10e8 cells/kg
12015469|NCT00477035|Drug|etoposide|60 mg/kg
12015470|NCT00477035|Drug|bcnu|15 mg/kg
12015471|NCT00477035|Drug|cyclophosphamide|100 mg/kg
12015472|NCT00477035|Drug|gemcitabine|1250 mg/m2
12015473|NCT00477035|Drug|vinorelbine|30 mg/m2
12015474|NCT00477035|Drug|melphalan|200 mg/m2
12015475|NCT00477022|Device|Vasotrain-447|
12015476|NCT00477009|Device|Mandibular repositioning appliance, adjustable|Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness.
12015477|NCT00476996|Drug|Leflunomide|Oral repeating dose
12015478|NCT00476996|Drug|Methotrexate|Oral or parenteral repeating dose
12015479|NCT00476996|Drug|Ocrelizumab|Intravenous repeating dose (200mg)
12015480|NCT00476996|Drug|Ocrelizumab|Intravenous repeating dose (500mg)
12015481|NCT00476996|Drug|Placebo|Intravenous repeating dose
12015482|NCT00476983|Drug|saquinavir/ritonavir plus truvada|SQV/r 1500/100 mg OD + Truvada OD for 2 years
12015483|NCT00476970|Behavioral|Patient Navigation|Patient navigators will perform an initial interview with participants to identify and explore barriers, work with patients to overcome barriers, educate patients about CRC screening, motivate and coach patients, and schedule and accompany patients to colonoscopy testing
12015484|NCT00476957|Device|Stent|Stent implantation
12015485|NCT00476957|Device|Stent|Stent implantation
12015486|NCT00476944|Procedure|Percutaneous Coronary Intervention (PCI)|
12015487|NCT00476931|Biological|SB-509|60 mg dose
12015488|NCT00476931|Other|Placebo|Saline
12015489|NCT00476918|Drug|Intravitreal injection (triamcinolone acetonide)|
12015490|NCT00476905|Device|Spectral Diagnosis Probe|The device collects two types of tissue spectra: i) laser-induced fluorescence spectra and ii) white light reflectance spectra. This portable reflectance spectrofluorimeter collects spectra in a fraction of a second. Light collection and delivery are achieved via an optical fiber probe. The optical fiber probe is approximately 1 mm in diameter and 3 m long. The same probe collects light emitted from the tissue and delivers it back to the instrument for spectral analysis.
12015491|NCT00476892|Procedure|Pelvic Floor Muscle Training|Women in the intervention group attend 5 physiotherapy sessions. At each appointment a clinical history is taken, pelvic floor muscle assessment carried out, exercises taught and prescribed, and appropriate lifestyle advice given. At the first of these appointments a detailed explanation of the pelvic anatomy and different types of prolapse is given.
12015492|NCT00476879|Drug|Somatropin and pegvisomant|Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
12015493|NCT00476866|Device|intermittent positive-pressure breathing (IPPB)|
12015494|NCT00476853|Drug|HAART containing nevirapine|Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.
12015495|NCT00476827|Drug|Bevacizumab|Bevacizumab(Avastin) 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. until progression or unacceptable toxicity develops
12015496|NCT00476827|Drug|Docetaxel|Docetaxel 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops
12015497|NCT00476827|Drug|CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops
12015498|NCT00476827|Drug|Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops
12015499|NCT00476827|Drug|Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops
12015500|NCT00476827|Drug|Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.until progression or unacceptable toxicity develops
12015501|NCT00476801|Device|German manufactured UVA1 light emitting device|The UVA1 dose will be up to 130 J/cm2.
12015502|NCT00476788|Device|Omnipod Insulin Management System|Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus
12015503|NCT00476775|Behavioral|after school ethnic dance program - ballet folklorica|
12015504|NCT00476775|Behavioral|culturally-tailored, home-based screen time reduction|
12015505|NCT00476775|Behavioral|culturally-tailored health and nutrition education|
12015506|NCT00476736|Drug|Effect on small airways (N-Acetylcystein)|
12015507|NCT00476710|Drug|Colesevelam HCl|
12015508|NCT00476697|Device|German manufactured UVA1 emitting light system|The dose and scheduling of irradiation is as follows: Up to 130J/cm2 from a UVA1 Sellamed irradiation device with irradiations up to 5 times per week.
12015509|NCT00476684|Procedure|radiofrequency treatment|Radiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks
12015510|NCT00476684|Procedure|sham neurotomy|Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
12015511|NCT00476671|Procedure|lumbar puncture, MRI, MRS|lumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia
12015512|NCT00476645|Drug|Fulvestrant|Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly
12015513|NCT00476632|Behavioral|Questionnaire|50 Minute Interview
12015514|NCT00476619|Drug|erythropoeitin|Subjects will receive a one-time dose of either placebo, or EPO 40,000 U intravenously 30 to 240 minutes prior to intravenous contrast administration.
12015515|NCT00476606|Drug|Zidovudine, Stavudine, Didanosine, Lamivudine|Refer to the Thai guideline for HIV management 2007
12015516|NCT00476606|Drug|Nevirapine, Efavirenz|Refer to the Thai guideline for HIV management 2007
12015517|NCT00476606|Drug|LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir|Refer to the Thai guideline for HIV management 2007
12015518|NCT00476593|Drug|Diclofenac|"Preservative- free Diclofenac Na 0.1% eye drops (Voltaren Ophta SDU;Novartis Pharms). One drop four times daily in one eys for three days.
~The evaluation of macular thickness/function after 3 days use of anti-inflammatory eye drops in healthy subjects is the only sub-study involving an intervention design."
12015519|NCT00476593|Drug|Dexamethasone|"Dexamethasone sodium phosphate 0.1% eye drops (Spersadex OmniVision, Novartis Pharma), one drop six times daily for three days in one eye.
~Pharms). One drop four times daily in one eys for three days.
~The evaluation of macular thickness/function after 3 days use of anti-inflammatory eye drops in healthy subjects is the only sub-study involving an intervention design."
12015520|NCT00476580|Behavioral|Questionnaire|Questions to collect health information specific to Sri Lankans.
12015521|NCT00476567|Other|standard|standard antenatal care
12015522|NCT00476567|Behavioral|specific training program|a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.
12015523|NCT00476554|Drug|Sapacitabine|Sapacitabine
12015524|NCT00476541|Drug|Gemtuzumab ozogamicin|Two courses of Gemtuzumab vs. no further therapy
12015525|NCT00476528|Behavioral|Reality Orientation|Two matched groups of patients diagnosed with TBI are selected from two university hospitals. In addition to conventional treatment, patients in one group are introduced to a reality- orientation programme consisting of systematic orientation, information, and systematic cooperation with the patient´s relatives.Patients in the other group receive conventional treatment only. All patients are tested on a daily basis in accordance with the RLAS and the GOAT test.
12015526|NCT00476528|Behavioral|Reality Orientation|A quasiexperimental study
12015527|NCT00476515|Drug|Rituximab|the recommended dosage of Rituximab is 375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22).
12015528|NCT00476502|Genetic|identify genetic polymorphism in Thai HIV infected|Gene sequencing of Cyp450 metabolic pathway
12015529|NCT00476476|Drug|Erlotinib|Orally every day for about 4-6 weeks
12015530|NCT00476463|Drug|Emtricitabine|Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
12015531|NCT00476437|Drug|biphasic insulin aspart|
12015532|NCT00476437|Drug|biphasic human insulin|
12015533|NCT00476424|Drug|efavirenz|EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days
12015534|NCT00476411|Biological|HBV vaccine|HBV vaccine 3 doses at month 0, 1, and 6
12015535|NCT00476398|Procedure|Capsule endoscopy|Patient will undergo a capsule endoscopy for the evaluation of their chest pain.
12015536|NCT00476385|Drug|somatropine|subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg
12015537|NCT00476359|Drug|Lopinavir/r plus saquinavir|lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily
12015538|NCT00476346|Dietary Supplement|Calcium & Vitamin D|Calcium 2000mg / daily Vitamin D 800IU / daily
12015539|NCT00476333|Device|APOS biomechanical gait system|
12015540|NCT00476320|Procedure|Magnetic Resonance Imaging|
12015541|NCT00476320|Procedure|Revascularization|
12015542|NCT00476320|Procedure|Echocardiography with myocardial deformation imaging|
12015543|NCT00476307|Biological|Fluarix™/Influsplit SSW® 2007/2008|
12015544|NCT00476294|Other|Telephone Questionnaire|Follow-Up Telephone Calls Every 6 Months for 5 Years.
12015545|NCT00476281|Procedure|Urinary collect|
12015546|NCT00476281|Procedure|Continuous Glucose Monitoring System (CGMS)|
12015547|NCT00476268|Drug|beclomethasone/formoterol (100/6µg) pMDI|Two puffs b.i.d
12015548|NCT00476268|Drug|Beclometasone dipropionate 250 µg/unit dose pMDI|2 inhalations bid
12015549|NCT00476268|Drug|Formoterol powder 12 µg/unit dose|2 inhalations bid
12015550|NCT00476255|Behavioral|Enhanced Standard Care (ESC)|Reading material
12015551|NCT00476255|Behavioral|Brief Motivational Intervention (BMI)|Motivational interview with trained therapist
12015552|NCT00476242|Drug|Vivitrol|intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
12015553|NCT00476242|Drug|memantine|Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment.
12015554|NCT00476229|Drug|Thymoglobulin|1.5 mg/kg by vein on Days -11 to -7.
12015555|NCT00476229|Radiation|Total Lymphoid Irradiation|80 cGy daily on days -11 to -7 and -4 to 0.
12015556|NCT00476229|Procedure|Peripheral Blood Stem Cell Infusion|PBSC infusion administered on day 0.
12015557|NCT00476229|Drug|Rituximab|375 mg/m^2 by vein on days -13, -6, 1, & 8. Only those patients whose tumors express CD20 will receive Rituximab.
12015602|NCT00475969|Drug|placebo|
12015603|NCT00475956|Drug|AZD2171|oral tablet multiple ascending doses 20, 30 or 45 mg
12015558|NCT00476216|Drug|Combination of Arixtra with chemotherapy|"Single arm, 2 cohort feasibility study:
~Carboplatin will be administered intravenously over approximately 30 minutes after paclitaxel infusion is completed and the dose will be calculated on basis of an area under the curve (AUC) of 6, according to the formula administered every 21 days. Paclitaxel will be administered 200 mg/m2 over 3 hours every 21 days.
~Patients in both cohorts 1 & 2 will receive standard chemotherapy alone during cycle 1.
~Cohort 1:During subsequent cycles (2-4) patients will receive a daily prophylactic dose (day 1 through 21) of Arixtra and continue 21 days after the last course of chemotherapy.
~Cohort 2: Patients in cohort 2 will receive standard chemotherapy alone during cycle 1. During subsequent cycles, the patient will receive a therapeutic weight based dose of Arixtra for the first 2 days of each chemotherapy cycle followed by a daily prophylactic dose of Arixtra (day 3 through 21) until the next course of chemotherapy."
12015559|NCT00476203|Behavioral|Yoga|Instructor-led yoga classes 1/time per week + 4 days of home practice
12015560|NCT00476203|Other|Delayed yoga classes|Delayed yoga classes (after 6 months) offered [wait list control group]
12015561|NCT00476190|Drug|Doxorubicin|Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.
12015562|NCT00476190|Drug|Cytarabine|Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks
12015563|NCT00476190|Drug|Methotrexate|"Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (prior to IV).
~Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks."
12015564|NCT00476190|Drug|Vincristine|Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.
12015565|NCT00476190|Drug|Cyclophosphamide|Consolidation IB: Intravenously on day 1
12015566|NCT00476190|Drug|Methylprednisone|Prophase: Intravenously on days 1-3
12015567|NCT00476190|Drug|Hydrocortisone Sodium Succinate|Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.
12015568|NCT00476190|Drug|Dexamethasone|Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.
12015569|NCT00476190|Drug|6-MP|Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.
12015570|NCT00476190|Drug|PEG-Asparaginase|"Consolidation IC: Intravenously every 3 weeks, starting on day 8. CNS Therapy: Intravenously every 3 weeks, starting 3 weeks after the Consolidation IC dose.
~Consolidation II: Intravenously every 3 weeks."
12015571|NCT00476190|Drug|Imatinib|Used for PH+ ALL subjects enrolled prior to May 1st 2011 only and is used continuously throughout every phase of treatment.
12015572|NCT00476190|Drug|Etoposide|Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.
12015573|NCT00476190|Procedure|Radiation Therapy|Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF
12015574|NCT00476190|Drug|E. coli Asparaginase|Intramuscularly Day 7 of Induction.
12015575|NCT00476177|Biological|Infusion of donor dendritic cells|Given in the outpatient setting
12015576|NCT00476177|Biological|Infusion of donor lymphocytes|Given in outpatient setting
12015577|NCT00476164|Drug|Rituximab|2 doses of 1g 14 days apart
12015578|NCT00476164|Other|Control arm|Continue of optimised oral immunosuppression
12015579|NCT00476151|Drug|EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream|topical cream applied daily for 4 weeks
12015580|NCT00476151|Drug|placebo cream|inactive placebo cream applied two times daily
12015581|NCT00476138|Drug|Epigallocatechin-gallate|
12015582|NCT00476125|Behavioral|Dietary manipulation ketogenic diet|Subjects will consume a ketogenic diet for 3 days.
12015583|NCT00476125|Behavioral|Dietary Manipulation - 12 day ketogenic diet|Subjects will consume a ketogenic diet for 12 days.
12015584|NCT00476125|Behavioral|16 Hour Fast|Subjects will fast for 16 hours.
12015585|NCT00476112|Drug|Vernakalant Injection 20 mg/mL|
12015586|NCT00476099|Drug|Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI|Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
12015587|NCT00476099|Drug|Budesonide 200 µg plus formoterol 6 µg DPI|two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
12015588|NCT00476099|Drug|Formoterol 12 µg DPI|one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
12015589|NCT00476086|Drug|Gemcitabine|
12015590|NCT00476086|Drug|Oxaliplatin|
12015591|NCT00476086|Radiation|Radiation|
12015592|NCT00476073|Drug|FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)|
12015593|NCT00476060|Procedure|Autologous mesenchymal stem cell transplantation|Arm A: 300 million cells will be infused one time through a peripheral vein/// Arm B: Infusion of placebo one time through a peripheral vein
12015594|NCT00476047|Combination Product|Tositumomab and Iodine I 131 Tositumomab|Give IV
12015595|NCT00476034|Drug|lumiracoxib|
12015596|NCT00476021|Device|Levonorgestrel-releasing IUD (Mirena)|levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
12015597|NCT00476008|Drug|Memantine|One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
12015598|NCT00476008|Drug|Placebo|One tablet placebo morning and evening (BID) for 12 months
12015599|NCT00475982|Behavioral|Weight Loss|Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
12015600|NCT00475982|Other|No Weight Loss Group|These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
12015604|NCT00475956|Drug|AZD0530|oral tablet multiple ascending doses 125 mg or 175 mg
12015605|NCT00475930|Drug|2% chlorhexidine gluconate (CHG) impregnated cloths|self applied three times per week
12015606|NCT00475930|Drug|Comfort Bath cloths (placebo cloths)|self applied three times weekly
12015607|NCT00475917|Drug|XL844|Gelatin capsules supplied as 5-mg, 25-mg, and 100-mg strengths; twice-weekly dosing.
12015608|NCT00475917|Drug|Gemcitabine|once-weekly 30-minute IV infusion
12015609|NCT00475904|Drug|EpiCept-NP-1 Cream|ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
12015610|NCT00475904|Drug|Gabapentin Capsules|1800mg/day capsules for 4 weeks
12015611|NCT00475904|Drug|placebo|placebo cream and caps
12015612|NCT00475878|Drug|escitalopram|10mg escitalopram/day for 3 months
12015613|NCT00475878|Drug|placebo|placebo capsule/day for 3 months
12015614|NCT00475865|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
12015615|NCT00475865|Drug|Placebo (for teriflunomide)|"Film-coated tablet
~Oral administration"
12015616|NCT00475865|Drug|Glatiramer Acetate (GA)|Solution in prefilled syringe for subcutaneous injection
12015617|NCT00475852|Drug|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
12015618|NCT00475852|Drug|Placebo|matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
12015619|NCT00475839|Device|Tension-free Vaginal Tape|
12015620|NCT00475839|Device|Monarc sub-fascial hammock|
12015621|NCT00475826|Drug|Statins and Ezetimibe|
12015622|NCT00475813|Drug|FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)|
12015623|NCT00475800|Drug|Lumiracoxib|
12015624|NCT00475787|Procedure|Spinal Manipulation|Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
12015625|NCT00475787|Procedure|Detuned Ultrasound|"US machine is turned on and set at 0 w/cm2"
12015626|NCT00475774|Behavioral|Long-chain (C18:2) and medium chain fatty acid (C8 and C10).|
12015627|NCT00475748|Procedure|Early and late surgery for traumatic central cord syndrome|Surgical decompression of the spinal cord, either front, back or combined
12015628|NCT00475735|Drug|MK0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
12015629|NCT00475735|Drug|Concerta (methylphenidate)|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
12015630|NCT00475735|Drug|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
12015631|NCT00475722|Behavioral|1 Healthy Eating|6 months telephone counseling
12015632|NCT00475722|Behavioral|2 Mediterranean|6 months telephone counseling
12015633|NCT00475709|Device|Trifecta Aortic Heart Valve|Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
12015634|NCT00475696|Drug|Duloxetine|
12015635|NCT00475683|Other|Mouth wash|Mouth wash with chlorehexidin, three times a day
12015636|NCT00475683|Dietary Supplement|Curcumol|5 ml in 50 ml water, mouthwash for 30 seconds, three times a day
12015637|NCT00475670|Drug|Trastuzumab|4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.
12015638|NCT00475670|Drug|Taxane (docetaxel or paclitaxel)|Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab.
12015639|NCT00475657|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles
12015640|NCT00475657|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 6 cycles
12015641|NCT00475644|Drug|Enzastaurin|Administered orally
12015642|NCT00475618|Procedure|topical fluoride varnish application.|Vanish application every 6 months in all accesible tooth surfaces
12015643|NCT00475618|Procedure|professional cleaning|Daily use fluoride toothpaste 500 ppm.
12015644|NCT00475618|Procedure|No fluoride toothpaste|Daily use no fluoride toothpaste.
12015645|NCT00475592|Device|Esophageal Capsule Endoscopy|
12015646|NCT00475592|Device|Upper Gastrointestinal Endoscopy|
12015647|NCT00475579|Procedure|tube with subglottic drainage and polyurethane cuff|
12015648|NCT00475566|Device|Dynalink®-E everolimus-eluting peripheral stent|Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
12015649|NCT00475566|Device|Dynalink®-E, everolimus-eluting peripheral stent|Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
12015650|NCT00475553|Other|remove ring if bleeding or spotting occurs more than 5 days|Both groups of women will be using the nuvaring continuously, ie if the ring is placed on 3rd of January, on the 3rd of February the ring would be removed and a new one inserted. On the 3rd of March the same thing would happen and so forth. Group 2 if bleeding or spotting occurs for more than 5 days then on the 6th day the ring is removed and will keep it out for three more days and reinsert the same ring on the 4th day.
12015651|NCT00475553|Other|If bleeding does not remove ring|Subject is using the nuvaring continuously. For example she puts the ring in on 3rd of January then the 3rd of February is when that ring is removed and another one is inserted. The 3rd of March the same thing occurs.
12015652|NCT00475540|Device|synthetic monofilament polypropylene mesh|Vaginal prolapse repair with mesh
12015653|NCT00475527|Drug|omeprazole,clarithromycin,amoxicillin (or metronidazole)|
12015654|NCT00475514|Drug|Frovatriptan 2.5mg QD|
12015655|NCT00475514|Drug|Frovatriptan 2.5 mg BID|
12015656|NCT00475514|Drug|placebo|
12015657|NCT00475501|Drug|Testosterone Enanthate|125 mg, i.m. injection, once/week, for 52 weeks
12015658|NCT00475501|Drug|Finasteride|5 mg, oral, once/day, for 52 weeks
12015659|NCT00475501|Other|Placebo|Placebo
12015660|NCT00475488|Procedure|Coronary artery bypass grafting|Surgery performed due to coronary artery disease.
12015661|NCT00475475|Behavioral|Fructose|25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
12015662|NCT00475475|Behavioral|glucose|25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
12015663|NCT00475475|Behavioral|non-caloric sweetener|25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
12015664|NCT00475462|Drug|metoprolol|
12015665|NCT00475462|Drug|conventional treatment|
12015666|NCT00475449|Procedure|percutaneous coronary intervention|
12015667|NCT00475449|Procedure|coronary artery bypass grafting|
12015668|NCT00475436|Drug|GSK573719|
12015669|NCT00475423|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
12015670|NCT00475410|Drug|ASCs (Cx401, company code)|"Experimental: ASCs: Subjects will be treated with a dose of 20 million ASCs and evaluated after 12 weeks. If needed a second dose of 40 million ASCs will be applied then.
~Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 20 million ASCs plus fibrin glue and evaluated after 12 weeks. If needed a second dose of 40 million ASCs plus fibrin glue will be applied then."
12015671|NCT00475410|Drug|Fibrin adhesive|Experimental: Fibrin glue: Subjects will be treated with a dose fibrin glue and evaluated after 12 weeks. If needed a second dose of fibrin glue will be applied then.
12015672|NCT00475397|Drug|Duloxetine|
12015673|NCT00475397|Drug|Placebo|
12015674|NCT00475371|Drug|MKC253 Inhalation Powder|Inhalation powder
12015675|NCT00475358|Drug|Duloxetine|
12015676|NCT00475358|Drug|Placebo|
12015677|NCT00475345|Behavioral|Bedtime snacks|
12015678|NCT00475332|Drug|Iodine I -01 Tositumomab (Bexxar)|"Patients will be treated in two dosing phases, each phase includes two infusions. The first phase, termed dosimetric dose, involves an intravenous administration of 450 mg unlabeled tositumomab followed by an intravenous administration of 5 mCi (0.18 GBq) of I-131 tositumomab for the purpose of determining the rate of whole body clearance of radioactivity (residence time) so that the administered activity (mCi or GBq) to deliver a 75 cGy (or 65 cGy for patients with baseline platelet count from 100,000 to 149,999/mm^3) total body radiation dose can be calculated."
12015679|NCT00475332|Procedure|External Beam Radiation Therapy|All patients are to receive 20 Gy in 10 fractions of 200 cGy to the PTV
12015680|NCT00475319|Drug|placebo|comparison of different dosages of drug
12015681|NCT00475319|Drug|1% OPC-12759 ophthalmic suspension|comparison of different dosages of drug
12015682|NCT00475319|Drug|2% OPC-12759 ophthalmic suspension|comparison of different dosages of drug
12015683|NCT00475306|Drug|metoclopramide 10 mg|an anti-emetic medication
12015684|NCT00475306|Drug|Diphenhydramine 25 mg|used for prophylaxis against akathisia
12015685|NCT00475306|Drug|Placebo|placebo
12015686|NCT00475306|Drug|Metoclopramide 20 mg|Metoclopramide 20 mg
12015687|NCT00475293|Drug|Panitumumab and CPT-11|"Panitumumab will be administered by IV infusion on day 1 of each cycle just prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg
~Irinotecan: 350 or 300 mg/m2. day 1
~One treatment cycle is defined as the 21 day period following the commencement of treatment with panitumumab + irinotecan plus additional time, as needed, for the resolution of irinotecan-related toxicities"
12015688|NCT00475280|Procedure|Geriatric assessment adapted therapy|Geriatric assessment is performed before the induction phase starts.
12015689|NCT00475280|Procedure|Stem cells autotransplantation|Stem cells autotransplantation is performed after consolidation treatment
12015690|NCT00475267|Device|Trifecta aortic heart valve|Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.
12015691|NCT00475241|Behavioral|Prolonged Exposure therapy for PTSD|exposure-based treatment for PTSD
12015692|NCT00475241|Behavioral|Present centered therapy for PTSD|present focused coping and problem solving for PTSD
12015693|NCT00475228|Drug|Levonorgestrel IUD|intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem
12015694|NCT00475215|Drug|Sugammadex|Sugammadex solution for injection.
12015695|NCT00475215|Drug|Rocuronium|Rocuronium bromide solution for injection.
12015696|NCT00475189|Drug|loestrin 24/4 vs loestrin 1/20|One month of loestrin 1/20 then randomized to Loestrin 24/4 or Loestrin 1/20 x 3 months. After 3 months if randomized to 1/20 will be switched to 24/4 if already on 24/4 will be given a choice which OC they want to continue for 3 more months.
12015697|NCT00475189|Drug|loestrin 1/20|loestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE
12015698|NCT00475176|Drug|Peginterferon alfa-2a|
12015699|NCT00475176|Drug|Ribavirin|
12015700|NCT00475176|Drug|S-adenosyl methionine for Chronic Liver Disease|
12015701|NCT00475163|Behavioral|Behavior modification|
12015702|NCT00475150|Drug|cediranib maleate|Given orally
12015703|NCT00475150|Other|laboratory biomarker analysis|Correlative studies
12015704|NCT00475137|Drug|Lamotrigine|Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. For subjects in this combination therapy arm, antidepressant dose will remain constant throughout the study.
12015705|NCT00475137|Drug|Lamotrigine|Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. Subjects in this group will discontinue their antidepressants prescribed to them before the study.
12015706|NCT00475124|Device|Home Monitoring of pacemaker|Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.
12015707|NCT00475124|Device|Home Monitoring of pacemaker deactivated|No Home Monitoring data transmission.
12015708|NCT00475111|Behavioral|Cognitive Behavior Therapy for Pain (CBT-P)|
12015709|NCT00475111|Behavioral|Mindfulness Meditation for Emotion Regulation (MM-ER)|
12015710|NCT00475111|Behavioral|Rheumatoid arthritis education|
12015711|NCT00475098|Drug|Tinzaparin sodium 100 UI/Kg/OD for 12 weeks|treatment in lung tumours
12015712|NCT00475085|Drug|aprepitant|Given orally or IV
12015713|NCT00475085|Drug|dexamethasone|Given orally or IV
12015714|NCT00475085|Drug|granisetron hydrochloride|Given orally or IV
12015715|NCT00475085|Drug|palonosetron hydrochloride|Given orally or IV
12015716|NCT00475085|Drug|prochlorperazine|Given orally or IV
12015717|NCT00475085|Drug|placebo|Given orally
12015718|NCT00475072|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 48 weeks
12015719|NCT00475072|Drug|ribavirin|1000/1200mg po daily for 48 weeks
12015720|NCT00475059|Drug|cimetidine arrow|patients who received cimétidine
12015721|NCT00475046|Behavioral|Motivational Interviewing|
12015722|NCT00475033|Biological|13-valent Pneumococcal Conjugate Vaccine|13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
12015723|NCT00475033|Biological|7-valent pneumococcal conjugate vaccine|7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
12015724|NCT00475020|Drug|Busulfan|Test dose = 32 mg/m^2 by vein x 1 day; 100 mg/m^2 by vein daily over 3 hours x 4 days
12015725|NCT00475020|Drug|Fludarabine|40 mg/m^2 by vein daily over 1 hour x 4 days
12015726|NCT00475020|Drug|Thymoglobulin (ATG)|2.5 mg/kg by vein over 6 hours x 3 days if there is an unrelated or a mismatched donor
12015727|NCT00475007|Device|IBV® Valve System|The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
12015728|NCT00474994|Drug|sunitinib malate|
12015729|NCT00474981|Behavioral|IMNCI|Implementation of IMNCI in the intervention sites
12015730|NCT00474968|Device|e2 Cell Collector [SoftPAP(R)]|Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]
12015731|NCT00474968|Device|Spatula/Brush|Cervical cells collected using a combination of a cervical spatula and an endocervical brush
12015732|NCT00474955|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms or 135 micrograms sc weekly for 48 weeks
12015733|NCT00474929|Drug|RAD001|Phase I: Dose level 0: RAD001 5mg every other day; Dose level 1: RAD001 5mg every day; Dose level 2: RAD001 5mg every day; Dose level 3: RAD001 10mg every day; Phase II: RAD001 5mg every day;
12015734|NCT00474929|Drug|Sorafenib|Phase I: Dose level 0: Sorafenib 200 mg twice daily; Dose level 1: Sorafenib 200 mg twice daily; Dose level 2: Sorafenib 400 mg twice daily; Dose level 3: Sorafenib 400 mg twice daily; Phase II: Sorafenib 200 mg twice daily;
12015735|NCT00474916|Drug|KRN5500|Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo . The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2.
12015736|NCT00474916|Drug|Placebo|Normal Saline given as dose escalation for placebo
12015737|NCT00474903|Drug|acetylsalicylic acid|Given orally
12015738|NCT00474903|Drug|esomeprazole magnesium|Given orally
12015739|NCT00474903|Other|placebo|Given orally
12015740|NCT00474890|Drug|cetericine and pseudoephedrine|
12015741|NCT00474877|Device|Static resting splints|
12015742|NCT00474864|Drug|GW856553|
12015743|NCT00474851|Drug|Norethindrone acetate + estrogens|Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily
12015744|NCT00474851|Drug|norethindrone acetate + placebo|norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily
12015745|NCT00474838|Drug|intensive insulin group|Once daily long acting insulin and preprandial rapid acting insulin injection
12015746|NCT00474838|Drug|Oral AntiDiabetic Drug (glimepiride and metformin)|glimepiride and metformin combined therapy
12015747|NCT00474825|Drug|Hyperbaric Oxygen Therapy|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
12015748|NCT00474825|Drug|Hyperbaric Oxygen|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
12015749|NCT00474825|Drug|Hyperbaric oxygen|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
12015750|NCT00474825|Drug|Hyperbaric oxygen|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
12015751|NCT00474812|Drug|dasatinib|
12015752|NCT00474812|Procedure|laboratory biomarker analysis|Correlative study
12015753|NCT00474812|Procedure|physiologic testing|Correlative study
12015754|NCT00474799|Drug|MNS075|MNS075 7.5mg q1h MNS075 15mg q3h
12015755|NCT00474786|Drug|Sorafenib|Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
12015756|NCT00474786|Drug|temsirolimus (Torisel)|Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.
12015757|NCT00474773|Drug|Celecoxib|
12015758|NCT00474760|Drug|CP-751,871|Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
12015759|NCT00474734|Device|Intravascular ultrasound of the liver|
12015760|NCT00474721|Drug|ibuprofen|
12015761|NCT00474721|Drug|acetaminophen with codeine|
12015762|NCT00474708|Drug|Effexor|
12015763|NCT00474708|Drug|SSRI|
12015764|NCT00474695|Drug|Lucentis|0.05 mg intravitreal injection
12015765|NCT00474682|Drug|Micronized dispersible ferric pyrophosphate|
12015766|NCT00474669|Drug|docetaxel|Docetaxel will be administered in normal-saline delivered at an inflow temperature of 42 degreesC for 90 minutes by the technique described in Appendix D of the protocol
12015767|NCT00474656|Device|High-frequency oscillation|
12015768|NCT00474656|Device|Conventional lung-open mechanical ventilation|
12015769|NCT00474630|Drug|Naltrexone SR 32 mg/bupropion SR 360 mg/ day|
12015770|NCT00474630|Drug|Placebo|
12015771|NCT00474630|Behavioral|Ancillary therapy|Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
12015772|NCT00474617|Drug|Sugammadex|
12015773|NCT00474617|Drug|Rocurium|intravenous (IV) single bolus dose of 0.6 mg.kg-1
12015774|NCT00474604|Procedure|diffusion-weighted magnetic resonance imaging|A scan will be performed.
12015775|NCT00474604|Procedure|dynamic contrast-enhanced magnetic resonance imaging|A scan will be performed.
12015776|NCT00474604|Procedure|magnetic resonance spectroscopic imaging|A scan will be performed.
12015777|NCT00474591|Drug|Fondaparinux|
12015778|NCT00474565|Procedure|Placement of an aortic root pigtail catheter.|Seldinger technique for placement of catheter.
12015779|NCT00474552|Drug|SAM-315|Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;
12015780|NCT00474539|Biological|13-valent pneumococcal conjugate vaccine|1 dose at 2,4,6 and 15 months of age
12015781|NCT00474539|Biological|7-valent pneumococcal conjugate vaccine|1 dose at 2,4,6 and 15 months of age
12015782|NCT00474526|Biological|Meningococcal ACWY Conjugate Vaccine|
12015783|NCT00474526|Biological|DTaP-IPV-HBV|
12015784|NCT00474526|Biological|Hib|
12015785|NCT00474526|Biological|Rotavirus|
12015786|NCT00474526|Biological|Pneumococcal 7-valent Conjugate Vaccine|
12015787|NCT00474526|Biological|HAV|
12015788|NCT00474526|Biological|MMR-V|
12015789|NCT00474526|Biological|DTaP|
12015790|NCT00474513|Drug|GSK239512|
12015791|NCT00474500|Drug|Coca, Cola, Diet Coke|
12015792|NCT00474487|Biological|Meningococcal ACWY Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
12015793|NCT00474487|Biological|MenACWY CRM (19 to 55 years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
12015794|NCT00474487|Biological|Meningococcal ACWY Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
12015795|NCT00474487|Biological|Novartis MenACWY Vaccine (56 to 65 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.
12015796|NCT00474474|Procedure|Virtual patient is NOT introduced|
12015797|NCT00474461|Biological|Treatment group|Intracoronary injection of cardiac stem cells
12015798|NCT00474435|Drug|Emtricitabine/tenofovir/efavirenz|"Co-formulated in one tablet (taken once daily by oral administration):
~emtricitabine 200 mg
~tenofovir DF 300 mg
~efavirenz 600 mg"
12015799|NCT00474422|Behavioral|Proactive assignment to attend a breastfeeding clinic|
12015800|NCT00474409|Drug|Merislon|
12015801|NCT00474396|Behavioral|Low fat dairy diet|
12015802|NCT00474383|Drug|Abiraterone acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.
12015803|NCT00474383|Drug|Glucocorticoid|Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.
12015804|NCT00474370|Drug|Vicriviroc|One tablet of vicriviroc 30 mg once daily.
12015805|NCT00474370|Drug|Placebo|One tablet of placebo once daily.
12015806|NCT00474357|Behavioral|Brief Structured Psychoeducation Group Therapy|weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients
12015807|NCT00474305|Behavioral|Virtual Reality Treatment for PTSD|12 session protocol for Prolonged Exposure with Virtual Reality. All sessions 90 minutes.
12015808|NCT00474279|Drug|Orally active growth hormone secretagogue (MK-677)|
12015809|NCT00474266|Biological|Meningococcal vaccine GSK134612 (Nimenrix)|Single dose intramuscular injection
12015810|NCT00474266|Biological|Priorix-Tetra|2-dose subcutaneous injection
12015811|NCT00474266|Biological|Meningitec|Single dose intramuscular injection
12015812|NCT00474253|Drug|Sugammadex|Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex
12015813|NCT00474253|Drug|Succinylcholine|Single bolus IV dose of 1.0 mg/kg succinylcholine
12015814|NCT00474253|Drug|Rocuronium|Single bolus IV dose of 1.2 mg/kg rocuronium
12015815|NCT00474240|Drug|Atorvastatin 20 mg|
12015816|NCT00474240|Drug|AEGR-733 5 mg|
12015817|NCT00474240|Drug|AEGR-733 10 mg|
12015818|NCT00474240|Drug|Placebo|
12015819|NCT00474240|Drug|AEGR-733 5 mg + atorvastatin 20 mg|
12015820|NCT00474240|Drug|AEGR-733 10 mg + atorvastatin 20 mg|
12015821|NCT00474227|Behavioral|group therapy, physical exercise, nutrition lectures|weekly group therapy, physical exercize, nutrition guidance
12015822|NCT00474214|Behavioral|Early hospital discharge facilitated by close nurse practitioner follow-up|
12015823|NCT00474201|Drug|Lopinavir/Ritonavir|lopinavir 400 mg + ritonavir 100 mg twice daily for 2 weeks
12015824|NCT00474201|Drug|Gemfibrozil|Control arm (no intervention used in this arm)
12015825|NCT00474188|Drug|CC-5013 (lenalidomide)|Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
12015826|NCT00474188|Drug|dexamethasone|Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
12015827|NCT00474175|Drug|Placebo gel|single dose (less than 1g) of a matching placebo gel
12015828|NCT00474175|Drug|benzocaine|single dose (less than 1g) of 10% benzocaine gel formulation
12015944|NCT00473239|Drug|cholecalciferol.|100,000 IU of Vitamin D
12015829|NCT00474175|Drug|benzocaine|single dose (less than 1g) of 20% benzocaine gel formulation
12015830|NCT00474162|Drug|Pentaspan®|15 ml/kg of starch solution, approximately 1 litre
12015831|NCT00474162|Drug|Normal Saline|15 ml/kg of either saline solution, approximately 1 litre
12015832|NCT00474136|Drug|Intravenous diclofenac sodium (DIC075V) 18.75 mg|DIC075V 18.75 mg
12015833|NCT00474136|Drug|Intravenous diclofenac sodium (DIC075V) 37.5 mg|DIC075V 37.5 mg
12015834|NCT00474136|Drug|Oral diclofenac potassium 50 mg|Oral diclofenac potassium 50 mg
12015835|NCT00474123|Drug|Simvastatin 80 mg/day for 6 weeks|Simvastatin 80 mg/day, single dose, for 6 weeks.
12015836|NCT00474123|Drug|Ezetimibe 10 mg / Simvastatin 20 mg|"Ezetimibe 10 mg / Simvastatin 20 mg
~Patients were treated with daily Ezetimibe 10 mg / Simvastatin 20 mg for 6 weeks"
12015837|NCT00474110|Drug|Ketamine & hydromorphone|See Detailed Description
12015838|NCT00474084|Device|Intravascular Coronary Stent|
12015839|NCT00474071|Drug|Remifentanil|See Detailed Description.
12015840|NCT00474058|Drug|Rotigotine|"Rotigotine transdermal patches:
~10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
~Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h"
12015841|NCT00474058|Other|Placebo|Placebo transdermal patches
12015842|NCT00474045|Drug|insulin detemir|Treat-to-target, dose titration, s.c. (under the skin) injection
12015843|NCT00474045|Drug|NPH insulin|Treat-to-target, dose titration, s.c. (under the skin) injection
12015844|NCT00474045|Drug|insulin aspart|Treat-to-target, dose titration, s.c. (under the skin) injection
12015845|NCT00474032|Drug|Botulinum Toxin (Type A) injection (10 U/Kg)|See Detailed Description.
12015846|NCT00474019|Drug|esomeprazole|IV qd for 4 days
12015847|NCT00474006|Drug|arm II|Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 90 mg/m2/d civ x 3 days
12015848|NCT00473980|Drug|Indomethacin, celecoxib, esomeprazole|
12015849|NCT00473967|Biological|Na-ASP-2 Hookworm Vaccine|Injections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection.
12015850|NCT00473954|Genetic|EGEN-001 (phIL-12-005/PPC)|"In stage 1, patients will receive standard doses of IV carboplatin and docetaxel for 2 treatment cycles with a 3 week interval. Patients will also receive 4 IP infusions of EGEN-001 at 12mg/m2 EGEN-001, 18mg/m2, or 24mg/m2, 10-11 days apart.
~Stage 2 of the study will involve cycle escalation at the highest EGEN-001 dose identified from Stage 1. All patients will receive up to 8 doses of EGEN-001, 10-11 days apart plus up to 4 IV carboplatin and docetaxel cycles with 3 week intervals. After receiving the assigned number of treatments of EGEN-001, carboplatin, and docetaxel, patients may continue to receive up to 4 additional infusions of EGEN-001 and 2 IV carboplatin and docetaxel cycles with 3 week intervals."
12015851|NCT00473941|Behavioral|Expressive writing|Quality of life measures through writing
12015852|NCT00473928|Drug|POT-4|Single intravitreal injection.
12015853|NCT00473915|Drug|fluticasone furoate|corticosteroid nasal spray
12015854|NCT00473902|Behavioral|Training|
12015855|NCT00473902|Drug|Creatine Monohydrate, Conjugated Linoleic Acid|
12015856|NCT00473889|Drug|vorinostat|vorinostat 400 mg capsules once daily. Up to 6 months of treatment
12015857|NCT00473889|Drug|Comparator: paclitaxel|intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
12015858|NCT00473889|Drug|Comparator: carboplatin|intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
12015859|NCT00473889|Drug|Comparator: placebo|vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment
12015860|NCT00473876|Drug|Metformin|Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks
12015861|NCT00473876|Drug|Matched Placebo (Capsules)|Similar dosing regime as active comparator
12015862|NCT00473863|Procedure|Coronary Computed Tomographic Angiography|CCTA will be performed
12015863|NCT00473837|Drug|Chloroquine|This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days
12015864|NCT00473837|Drug|Placebo|The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul
12015865|NCT00473824|Biological|Hepatitis C Immune Globulin Intravenous (Human) 5%|Hepatitis C Immune Globulin Intravenous (Human) 5%, [Civacir]: 18 infusions total, per schedule, of 300 or 400 mg/kg of body weight given with standard post-transplant therapy inclusive of immunosuppressive agents.
12015866|NCT00473811|Behavioral|Low GI|low-GI education
12015867|NCT00473811|Behavioral|ADA diet|ADA dietary education
12015868|NCT00473798|Behavioral|Questionnaire|Questionnaire
12015869|NCT00473785|Behavioral|Group-based motivational interviewing|
12015870|NCT00473785|Behavioral|Individual CVD-risk factor feedback|
12015871|NCT00473785|Behavioral|Education for protective health behavior change|
12015872|NCT00473772|Device|DEBlue stent vs. Cypher stent|DES vs. DEB with BMS
12015873|NCT00473746|Drug|Abiraterone acetate|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000mg/day until Maximum Tolerated Dose (MTD) and a recommended Phase II dose was established.
12015874|NCT00473746|Drug|Abiraterone acetate|Abiraterone acetate 1000 mg daily under fasted conditions upto 10 cycles of therapy.
12015875|NCT00473746|Drug|prednisone/prednisolone or dexamethasone|prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) concurrent with abiraterone acetate
12015876|NCT00473733|Procedure|GLP receptors expression|
12015877|NCT00473733|Procedure|ESOPHAGOGASTRODUODENOSCOPY|
12015878|NCT00473720|Drug|Satraplatin|Dose escalation of 40, 60 and 80 mg/m²/day on days 1-5
12015879|NCT00473720|Drug|Abraxane|Dose escalation of 80 and 100 mg/mm²/day on days 1,8,15,22 every 28 days
12015941|NCT00473317|Behavioral|Sun Exposure|Each subject will wear a swimming suit and be exposed to sunlight for 30 minutes total (15 minutes lying on back, 15 minutes lying on stomach).
12015880|NCT00473707|Procedure|Active management of the third stage of labor|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
12015881|NCT00473707|Procedure|Expectant management of the third stage of labor|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
12015882|NCT00473707|Drug|Oxytocin and gentle cord traction with fundal massage|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
12015883|NCT00473707|Drug|Oxytocin|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
12015884|NCT00473694|Drug|sugammadex|Administered as an intravenous (IV) infusion
12015885|NCT00473694|Drug|neostigmine|Administered as an IV infusion
12015886|NCT00473694|Drug|vecuronium|Administered as an IV infusion
12015887|NCT00473694|Drug|rocuronium|Administered as an IV infusion
12015888|NCT00473694|Drug|glycopyrrolate|Administered as an IV infusion
12015889|NCT00473681|Behavioral|Self-Help Intervention Program-High Blood Pressure|
12015890|NCT00473668|Biological|Zilbrix-Hib|Intramuscular injection, 1 dose
12015891|NCT00473668|Biological|Tritanrix™-HepB/ Hiberix™|Intramuscular injection, 1 dose
12015892|NCT00473655|Drug|rosuvastatin|10mg or 20mg
12015893|NCT00473642|Drug|Ranibizumab|intravitreal administered ranibizumab 0.5 mg in 0.05 mL
12015894|NCT00473642|Drug|Verteporfin|Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
12015895|NCT00473642|Drug|Verteporfin|Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
12015896|NCT00473616|Drug|AZD7762|intravenous infusion
12015897|NCT00473616|Drug|Irinotecan|intravenous injection
12015898|NCT00473603|Drug|lipid/heparin infusion|to perform an i.v. lipid heparin infusion infusion for 4 h
12015899|NCT00473590|Drug|Bevacizumab|15 mg/kg administered by intravenous infusion
12015900|NCT00473590|Drug|Bortezomib|1.3 mg/m^2 administered by intravenous bolus injection
12015901|NCT00473590|Drug|placebo|Intravenous repeating dose
12015902|NCT00473577|Drug|CRA-24781|
12015903|NCT00473564|Procedure|da Vinci® Robotic System|Head and Neck Surgery using the da Vinci® Robotic System
12015904|NCT00473551|Drug|Rituximab|375 mg/m^2 intravenously over several hours on Day -13, followed by 1000 mg/m^2 intravenously on Days -6, 1, and 8.
12015905|NCT00473551|Drug|Cyclophosphamide|50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine.
12015906|NCT00473551|Drug|Fludarabine|40 mg/m^2 intravenously over 30 minutes once per day for 4 days, starting Day -6.
12015907|NCT00473551|Drug|Mesna|10 mg/kg continuous intravenous infusion for 4 hours for total of 6 doses (24 hours) following Cyclophosphamide.
12015908|NCT00473551|Radiation|Radiation Treatment|2Gy Total body radiation day before transplantation
12015909|NCT00473551|Procedure|Stem Cell Transplantation (SCT)|Allo CD34+ Selected SCT/Infusion of stem cells.
12015910|NCT00473551|Drug|Sirolimus|6 mg by mouth on day -2 followed by 2 mg daily from day -1 through day +7.
12015911|NCT00473551|Procedure|Anti-third Party Cytolytic T-lymphocytes (CTL)|Intravenous infusion of anti-third party CTL.
12015912|NCT00473538|Behavioral|Structured exercise training|
12015913|NCT00473538|Behavioral|Hypocaloric hyperproteic diet|
12015914|NCT00473525|Drug|Placebo|Placebo QD
12015915|NCT00473525|Drug|PF-00734200 10 mg QD|10 mg QD
12015916|NCT00473525|Drug|PF-00734200 20 mg QD|20 mg QD
12015917|NCT00473525|Drug|PF-00734200 5 mg QD|5 mg QD
12015918|NCT00473525|Drug|PF-00734200 2 mg QD|2 mg QD
12015919|NCT00473512|Drug|Abiraterone acetate|Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.
12015920|NCT00473512|Drug|Abiraterone acetate MTD|Abiraterone acetate MTD orally for 12 cycles (28 day each).
12015921|NCT00473512|Drug|Dexamethasone|Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.
12015922|NCT00473499|Device|DEBlue vs Cypher vs BMS|BMS vs DES vs DEB+BMS
12015923|NCT00473486|Drug|pemetrexed, carboplatin, sorafenib|"Ph. 1: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; Sorafenib 200mg po bid days 2-19; 400mg po bid days 2-19
~Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1;sorafenib depending on results of Ph 1"
12015924|NCT00473486|Drug|pemetrexed, carboplatin, placebo|Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; placebo day 2-19
12015925|NCT00473473|Drug|Potassium Dichromate (Homeopathy)|twice daily with an interval of 12 hours, for a period of up to 14 days
12015926|NCT00473473|Drug|Placebo homeopathic remedy|identical to treatment without active component
12015927|NCT00473460|Drug|Avelox (Moxifloxacin, BAY12-8039)|Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
12015928|NCT00473460|Drug|Placebo|Matching placebo capsules orally once daily for 5 days every 8 weeks.
12015929|NCT00473447|Behavioral|Modified Constraint-induced movement therapy|
12015930|NCT00473434|Drug|Paliperidone|3mg or 6mg or 9mg or 12mg once daily for 52 weeks
12015931|NCT00473421|Procedure|Barium Sulphate and Zirconium Oxide|
12015932|NCT00473408|Device|Functional MRI (DCE-MRI)|MRI examination with i.v. gadolinium contrast to assess blood perfusion in remaining tumor tissue.
12015933|NCT00473408|Procedure|Blood sample|See protocol.
12015934|NCT00473408|Procedure|Tumor sample|See protocol.
12015935|NCT00473382|Drug|Ranibizumab|Sterile solution for intravitreal injection.
12015936|NCT00473382|Drug|Sham injection|
12015937|NCT00473356|Dietary Supplement|receive amino acid supplement|Receive amino acid supplement
12015938|NCT00473343|Procedure|Photodynamic therapy with Metvix 160 mg/g cream|
12015939|NCT00473330|Drug|Ranibizumab|Sterile solution for intravitreal injection.
12015940|NCT00473330|Drug|Sham injection|
12015942|NCT00473304|Device|Johnson&Johnson Acuevue daily disposable lenses|
12015943|NCT00473265|Drug|PTH|
12015946|NCT00473200|Dietary Supplement|S-adenosylmethionine|1200 mg daily
12015947|NCT00473187|Drug|somatropin|
12015948|NCT00473174|Drug|Ramipril|Dosing on awakening versus bedtime
12015949|NCT00473174|Device|ambulatory blood pressure monitoring|Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
12015950|NCT00473161|Device|surface EMG biofeedback|
12015951|NCT00473148|Procedure|BNP-guided weaning|BNP-guided weaning
12015952|NCT00473148|Procedure|Standard physician-directed weaning|Standard physician-directed weaning
12015953|NCT00473135|Biological|rDEN1delta30|Live attenuated rDEN1delta30 vaccine at a dose of 10^3 PFU
12015954|NCT00473135|Biological|Placebo|Placebo for rDEN1delta30
12015955|NCT00473122|Procedure|Delayed-Immediate Breast Reconstruction|Immediate reconstruction surgery if no XRT required; or reconstruction surgery delayed until XRT complete.
12015956|NCT00473109|Procedure|Dialysis without systemic heparinization|Dialysis without systemic heparinization
12015957|NCT00473096|Behavioral|Informed breast cancer surgical treatment|
12015958|NCT00473083|Drug|Minocycline|Patients will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.
12015959|NCT00473083|Drug|Clindamycin 2% in hydrocortisone 1% lotion|"Appropriate amounts of clindamycin and hydrocortisone powder are mixed with corresponding amount of Nutraderm® lotion for this mixture.
~If preferred, the appropriate amount of clindamycin powder can be mixed with Emo-Cort® lotion (already contains hydrocortisone 1%), available in 60 mL bottles."
12015960|NCT00473083|Drug|Erlotinib|Erlotinib will be given on an outpatient basis at a fixed dose of either 150 or 100 mg as a single daily oral dose.
12015961|NCT00473083|Drug|Topical clindamycin 2%, triamcinolone acetonide 0.1% soln|Clindamycin 2% in Triamcinolone acetonide 0.1% solution in equal parts propylene glycol and water
12015962|NCT00473070|Drug|Tobradex AF|
12015963|NCT00473057|Other|Autologous cell transplantation|Intra-arterial or intravenous delivery of autologous bone marrow cells
12015964|NCT00473044|Behavioral|Sisters in Motion|
12015965|NCT00473031|Behavioral|Caloric restriction, high protein|Weight loss with higher protein (35%) intake
12015966|NCT00473031|Behavioral|Caloric restriction; normal protein|Weight loss with recommended level of protein (18%)intake
12015967|NCT00473031|Behavioral|Counseling|Participants will be asked to attend eight 50-minute diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions, during the year.
12015968|NCT00473018|Behavioral|standard versus enhanced risk reduction counseling|
12015969|NCT00473005|Drug|Capecitabine|825 mg/m2 bid, Oral
12015970|NCT00473005|Drug|RAD001|2.5mg QOD, 2.5mg QD, 5.0mg QD, Oral
12015971|NCT00472966|Drug|Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels|Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10
12015972|NCT00472953|Drug|inhaled human insulin|Treat-to-target dose titration scheme, pre-prandial, inhalation.
12015973|NCT00472953|Drug|insulin aspart|Treat-to-target dose titration scheme, pre-prandial, injection s.c.
12015974|NCT00472927|Drug|Premarin/MPA 0.45 mg/1.5 mg|
12015975|NCT00472914|Device|portable surface electromyography|
12015976|NCT00472901|Drug|Afamelanotide (CUV1647)|16mg implant
12015977|NCT00472875|Drug|Glibenclamide|
12015978|NCT00472862|Behavioral|Cognitive training|Cognitive training for 16 weeks integrated in OPUS psychosocial treatment
12015979|NCT00472849|Drug|Oxaliplatin|Oxaliplatin 30 mg/m^2/day, over approximately 2 hours, before fludarabine is started, on days 1-4.
12015980|NCT00472849|Drug|Fludarabine|Fludarabine 30 mg/m^2 daily IV, over approximately 30 minutes, on days 2-3, 2-4, or 2-5 until maximum tolerated dose is reached.
12015981|NCT00472849|Drug|Cytarabine|Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose is started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose is reached.
12015982|NCT00472849|Drug|Rituximab|Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
12015983|NCT00472849|Drug|Pegfilgrastim|6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy
12015984|NCT00472836|Drug|CP-945,598|Administration of CP-945,598 in subjects with normal renal function.
12015985|NCT00472836|Drug|CP-945,598|Administration of CP-945,598 in subjects with severe renal impairment.
12015986|NCT00472823|Dietary Supplement|Vitamin D3|Orally for one year
12015987|NCT00472823|Dietary Supplement|Calcium Citrate (Citracal)|Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
12015988|NCT00472810|Device|ologen collagen matrix in glaucoma filtering surgery|If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
12015989|NCT00472810|Drug|MMC in glaucoma filtering surgery|If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
12015990|NCT00472797|Drug|Rebif New Formulation Non Titrated|human interferon beta 1a - Rebif New Formulation
12015991|NCT00472797|Drug|Rebif New Formulation Titrated|Human interferon beta 1a Rebif New Formulation
12015992|NCT00472771|Drug|INNO-206|
12015993|NCT00472758|Biological|MEDI 545|IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
12015994|NCT00472758|Other|Placebo|IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
12016091|NCT00471783|Procedure|Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.|
12015995|NCT00472745|Behavioral|Weight Loss|Weight loss participants will consume a reduced calorie diet based on their individual caloric needs to lose 1.5-2 lbs/week, and will attend regular counseling sessions (for about 45 minutes each) with a dietitian for 6 months
12015996|NCT00472745|Behavioral|Weight Maintenance|Diet for weight maintenance for 6 months
12015997|NCT00472719|Biological|VRC-HIVADV027-00-VP|Adenoviral vector booster vaccine
12015998|NCT00472719|Biological|VRC-HIVADV038-00-VP|Adenovirus vector booster vaccine
12015999|NCT00472719|Biological|VRC-HIVDNA044-00-VP|Experimental, multiclade, multigene HIV DNA vaccine
12016000|NCT00472706|Procedure|excision|excision 3 mm margin
12016001|NCT00472706|Procedure|Photodynamic therapy|Photodynamic therapy
12016002|NCT00472693|Drug|Bevacizumab, Abraxane|Bevacizumab, 10 mg/m2 IV days 1 and 15; ABI-007, 100 mg/m2 IV days 1, 8, 15 of each 28 day cycle. Continue treatment until disease progression, patient withdrawal or unacceptable toxicities.
12016003|NCT00472680|Behavioral|Caloric restriction, high protein|Weight loss with higher protein (35%) intake
12016004|NCT00472680|Behavioral|Caloric restriction; normal protein|Weight loss with normal level of protein (18%) intake
12016005|NCT00472680|Behavioral|Nutrition Education|Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month
12016006|NCT00472667|Procedure|Procalcitonin guided strategy|Procalcitonin guided strategy
12016007|NCT00472654|Behavioral|Weight Loss|Diet for weight loss for 6 weeks; all weight loss participants will attend 6 weekly counseling sessions (about 50 minutes per session)
12016008|NCT00472654|Dietary Supplement|Vitamin D 2500 IU|Daily Vitamin D 2500 IU supplement for 6 weeks
12016009|NCT00472654|Behavioral|Weight Maintenance|Diet for weight maintenance for 6 weeks
12016010|NCT00472641|Drug|Ziprasidone/Geodon|Ziprasidone/Geodon
12016011|NCT00472628|Procedure|Blood samples collected|
12016012|NCT00472576|Drug|MK-0657|Daily double-blind administration of the NR2B antagonist MK-0657 (4-8 mg/day)
12016013|NCT00472576|Drug|Placebo|Daily double-blind administration of placebo
12016014|NCT00472563|Drug|Bicarbinate 150 mEq/L|75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W
12016015|NCT00472550|Drug|esomeprazole 20 mg|
12016016|NCT00472537|Procedure|Retromuscular Mesh repair of midline incisional hernia|
12016017|NCT00472537|Procedure|Laparoscopic repair of midline incisional hernia|
12016018|NCT00472524|Procedure|Mydriasis/cycloplegia via different modes of administration|
12016019|NCT00472485|Procedure|eye movement therapy|
12016020|NCT00472472|Device|paclitaxel coated balloon catheter (device with drug)|PTA vs Paccocath
12016021|NCT00472459|Procedure|Photodynamic therapy with Metvix 160 mg/g cream|
12016022|NCT00472446|Drug|bilateral superficial cervical block|10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.
12016023|NCT00472446|Drug|placebo bilateral superficial cervical block|"10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
12016024|NCT00472433|Drug|Alemtuzumab|
12016025|NCT00472420|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv every 3 weeks
12016026|NCT00472420|Drug|First line chemotherapy|As prescribed
12016027|NCT00472381|Drug|Insulin|Insulin
12016028|NCT00472368|Drug|LBH589|
12016029|NCT00472355|Drug|apomorphine|
12016030|NCT00472342|Behavioral|exercise prescription|
12016031|NCT00472329|Procedure|Allogeneic hematopoietic stem cell graft using an allogeneic SCT HLA-Identical or non-identical family donor or unrelated donors|
12016032|NCT00472329|Drug|fludarabine|
12016033|NCT00472329|Procedure|TBI|
12016034|NCT00472316|Behavioral|Active Case Finding for Tuberculosis|Active case finding of TB in the community using community health workers
12016035|NCT00472303|Drug|Tapentadol Extended Release|Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 100 mg, increasing at a minimum of 3 day intervals by 50 mg, with a maximum dose of 250 mg.
12016036|NCT00472303|Drug|Matching Placebo after Tapentadol in the Titration Phase.|Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. In the maintenance phase only to participants that were randomized to tapentadol in the titration phase.
12016037|NCT00472303|Drug|Morphine Sulphate Controlled Release|Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 40 mg, increasing at a minimum of 3 days intervals by 20 mg, with a maximum dose of 100 mg. Maintenance phase: continuing on dose level established in titration phase.
12016038|NCT00472290|Drug|Romiplostim (formerly AMG 531)|"Subjects will begin the study at an initial dose of 750 µg.
~Except for:
~Subject whose doses were escalated to doses higher than 750 µg AMG 531 weekly, and maintained a response per IWG guidelines for platelet response.
~Subjects who were stable at a lower dose of AMG 531 on the previous study. Doses will be adjusted throughout the study based on individual subject's platelet count."
12016039|NCT00472264|Procedure|PET imaging|Medical imaging assessment
12016040|NCT00472238|Behavioral|endurance training|control group.
12016041|NCT00472238|Behavioral|exercise training|Treadmill exercise training to optimize physical endurance
12016042|NCT00472225|Drug|Rituximab|"Rituximab Induction: Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks
~Rituximab Maintenance: Rituximab 375 mg/m2 monthly IV for 4 consecutive months"
12016043|NCT00472212|Device|Spectacles|Hyperopic spectacle lenses
12016044|NCT00472212|Device|Control|Plano (no power, control) spectacle lenses
12016045|NCT00472199|Drug|Pramipexole|
12016046|NCT00472199|Drug|Placebo|
12016092|NCT00471744|Drug|Treatment with levetiracetam or sulthiame over a six-month period.|
12016047|NCT00472186|Drug|Lansoprazole|If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.
12016048|NCT00472186|Drug|Placebo|Placebo will also be administered based on weight.
12016049|NCT00472173|Drug|Mineral Trioxide Aggregate|Apexification treatment of the tooth with Mineral Trioxide Aggregate
12016050|NCT00472173|Drug|Calcium hydroxide|Apexification treatment of the tooth with Calcium hydroxide
12016051|NCT00472160|Procedure|Non Invasive Ventilation|Non Invasive Ventilation
12016052|NCT00472147|Procedure|shock efficacy|
12016053|NCT00472134|Drug|bupivacaine|administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.
12016054|NCT00472134|Device|On-Q PainBuster pump|local anesthetic (bupivacaine) administered via a pain relief system consisting of a 20 gauge soaker catheter attached to an elastomeric balloon pump that is capable of infusing a set volume of local anesthetic over a wide area of surgical site for 2 to 5 days
12016055|NCT00472121|Device|TOF-Watch SX (neuromuscular monitor)|The variation between arms (dominant or non-dominant) when monitored with the same method on both arms
12016056|NCT00472108|Procedure|PDT with Metvix 160 mg/g cream|
12016057|NCT00472108|Procedure|PDT with placebo cream|
12016058|NCT00472095|Procedure|fotonovela|
12016059|NCT00472082|Drug|efalizumab|Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study.
12016060|NCT00472069|Procedure|transplantation of the squeletic muscular cells|transplantation of the squeletic muscular cells
12016061|NCT00472056|Drug|Carmustine|300 mg/m^2 IV for 1 Day
12016062|NCT00472056|Drug|Etoposide|Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days
12016063|NCT00472056|Drug|Cytarabine|Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days
12016064|NCT00472056|Drug|Melphalan|140 mg/m^2 IV x 1 Day
12016065|NCT00472056|Drug|Rituximab|Cohort 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.
12016066|NCT00472043|Procedure|PDT with Metvix 160 mg/g cream and Placebo cream|
12016067|NCT00472030|Drug|Omalizumab|Patients will be treated with 150-375 milligrams of Omalizumab (Xolair), based on their baseline weight and serum Immunoglobulin E levels. Omalizumab will be administered subcutaneously on Day 1, and on Week 2, 4, 6, 8, 10, 12 and 14 treatment.
12016068|NCT00472030|Drug|prednisone|Prednisone, to a maximum dose of 0.5 mg/kg/day.
12016069|NCT00472017|Drug|vandetanib|Oral vandetanib administration will start on the same day as RT. Treatment with vandetanib will extend for the entire duration of RT, and then will be continued after completion of RT for a maximum duration of 2 years.
12016070|NCT00472004|Drug|17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)|17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
12016071|NCT00472004|Drug|Tibolone (Livial)|Tibolone 2.5 mg 1 daily, 1 year duration
12016072|NCT00471991|Drug|SH T04769G|The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator.
12016073|NCT00471991|Drug|Ethinyl estradiol / dienogest (SH D00659 AF)|The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator.Volunteers have to undergo a series of blood sampling during the 2nd treatment cycle to evaluate the pharmacokinetic (liberation, absorption, distribution, metabolization and excretion) of the new oral contraceptive.
12016074|NCT00471965|Drug|Oxaliplatin + 5-Fluorouracil/Leucovorin|"Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion.
~Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion.
~Repeated every 2 weeks"
12016075|NCT00471965|Drug|Doxorubicin|Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.
12016076|NCT00471952|Drug|Maxalt 10mg MLT plus Caffeine 75mg|One migraine attack will be treated
12016077|NCT00471952|Drug|Maxalt 10mg MLT plus Placebo|One migraine attack will be treated with Maxalt 10mg plus placebo
12016078|NCT00471952|Drug|Placebo + Placebo|One migraine attack will be treated with double placebo
12016079|NCT00471939|Drug|I-020502|1 mcg/mL TG-PDGF.AB
12016080|NCT00471913|Device|Femoral Nailing with Different Entry Points|See Detailed Description.
12016081|NCT00471900|Drug|dehydroepiandrosterone (DHEA)|
12016082|NCT00471887|Biological|CP-675,206|Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity.
12016083|NCT00471848|Drug|rabbit antithymocyte globulin|1.5 vials/10kg daily for 5 days
12016084|NCT00471835|Procedure|computed tomography|
12016085|NCT00471835|Procedure|positron emission tomography|
12016086|NCT00471835|Radiation|stereotactic body radiation therapy|
12016087|NCT00471809|Drug|Budesonide + Salmeterol + Azithromycin|
12016088|NCT00471809|Drug|Budesonide + Salmeterol + Montelukast|
12016089|NCT00471809|Drug|Budesonide + Salmeterol + Placebo|
12016090|NCT00471796|Behavioral|Biofeedback|
12016093|NCT00471718|Drug|ABT-751|"Phase I:
~Cohort | Number of Patients |Dose (mg) ABT-751 (BID)
~-1 | 3-6 |100 mg BID
~1 | 3-6 |125 mg BID
~2 | 3-6 |150 mg BID
~3 | 3-6 |175 mg BID
~4 | 3-6 |200 mg BID
~Phase II:
~Patients receive ABT-751 at 125mg po BID for 7 days on, 7 days off (X2) for a 28 day cycle"
12016094|NCT00471705|Drug|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
12016095|NCT00471705|Device|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
12016096|NCT00471705|Drug|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
12016097|NCT00471692|Drug|Ropivicaine|
12016098|NCT00471679|Drug|ethanol|
12016099|NCT00471653|Drug|temozolomide|
12016100|NCT00471653|Genetic|comparative genomic hybridization|
12016101|NCT00471653|Genetic|polymorphism analysis|
12016102|NCT00471653|Other|laboratory biomarker analysis|
12016103|NCT00471653|Other|pharmacological study|
12016104|NCT00471653|Radiation|radiation therapy|
12016105|NCT00471640|Drug|dexamethasone|4 days 5 mg
12016106|NCT00471627|Procedure|Pancreaticojejunostomy without stiches through the pancreas|The pancreas is cut with knife, without electric cautery and without stay sutures. Bleeding is controlled with 2-3 exactly placed stiches. The pancreatic stump is sunk inside the jejunum, which is tightened around the pancreas with a purse string. A biodegradable stent is left into the pancreatic duct to prevent its occlusion when tightning the purse string.
12016107|NCT00471614|Drug|NucleomaxX (contains uridine)|Escalated doses of NucleomaxX tid
12016108|NCT00471601|Behavioral|counseling intervention|
12016109|NCT00471601|Behavioral|questionnaire administration|
12016110|NCT00471601|Behavioral|psychosocial assessment and care|
12016111|NCT00471601|Behavioral|quality-of-life assessment|
12016112|NCT00471588|Drug|Pramipexole, Amisulpride|Study Drug
12016113|NCT00471575|Procedure|ultra sound examination|
12016114|NCT00471562|Biological|therapeutic angiotensin-(1-7)|sequentially increasing doses 50-1000 mcg/kg
12016115|NCT00471549|Drug|Statin (simvastatin)|
12016116|NCT00471536|Drug|pazopanib hydrochloride|800 mg Given orally
12016117|NCT00471523|Drug|Clomiphene citrate|
12016118|NCT00471523|Drug|Metformin|
12016119|NCT00471510|Drug|tetrapeptide aldehyde proteasome inhibitor (NEOSH101)|Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
12016120|NCT00471497|Drug|nilotinib|Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.
12016121|NCT00471497|Drug|imatinib|Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).
12016122|NCT00471484|Biological|recombinant interferon alfa-2b|
12016123|NCT00471484|Drug|doxorubicin hydrochloride|
12016124|NCT00471484|Drug|fluorouracil|
12016125|NCT00471484|Drug|oxaliplatin|
12016126|NCT00471484|Other|diagnostic laboratory biomarker analysis|
12016127|NCT00471484|Other|immunoenzyme technique|
12016128|NCT00471484|Other|immunohistochemistry staining method|
12016129|NCT00471484|Procedure|adjuvant therapy|
12016130|NCT00471484|Procedure|biopsy|
12016131|NCT00471484|Procedure|neoadjuvant therapy|
12016132|NCT00471484|Procedure|therapeutic conventional surgery|
12016133|NCT00471471|Biological|Peptide vaccine|Multi-epitope peptide vaccine containing MART-1 (26-35, 27L), gp100 (209-217, 210M) and tyrosinase (368-376, 370D) peptides
12016134|NCT00471471|Biological|GM-CSF|80 mcg/0.16 mL using lyophilized 500 mcg/vial reconstituted with 1 mL of sterile water given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).
12016135|NCT00471471|Biological|PF3512676|0.6 mg/0.04 mL given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).
12016136|NCT00471445|Drug|ketamine/amitriptyline NP-H cream|Subjects were instructed to apply up to, but not exceeding, 4 g of ketamine/amitriptyline NP-H cream two times per day to each area with pain, numbness, and/or tingling. A measuring device was provided to assist in dispensing the proper amount of the cream.
12016137|NCT00471445|Other|placebo|Applied topically
12016138|NCT00471432|Drug|custirsen sodium|
12016139|NCT00471432|Drug|docetaxel|
12016140|NCT00471432|Other|pharmacological study|
12016141|NCT00471419|Drug|Rimexolone|
12016142|NCT00471406|Procedure|Photodynamic Therapy with Verteporfin|
12016143|NCT00471393|Drug|1.5% diclofenac in 45.5% DMSO (topical treatment)|
12016144|NCT00471393|Drug|45.5% DMSO (topical placebo)|
12016145|NCT00471380|Drug|travoprost 0.004% and brinzolamide 1%|Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)
12016146|NCT00471380|Drug|fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle|group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
12016147|NCT00471367|Drug|AZD4877|intravenous infusion administered twice a week for 2 weeks
12016148|NCT00471354|Drug|Atomoxetine|atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
12016149|NCT00471341|Drug|Celecoxib|
12016150|NCT00471341|Drug|placebo|
12016151|NCT00471328|Drug|Nilotinib|Nilotinib 400 mg twice daily (bid)
12016152|NCT00471328|Other|Best Supportive Care (BSC) +/- imatinib or sunitinib|Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.
12016153|NCT00471315|Drug|Duloxetine|A preliminary, open-label single center study of duloxetine in patients with SOD
12016154|NCT00471289|Device|PTA with placement of paclitaxel-eluting stent|PTA with placement of paclitaxel-eluting stent
12016156|NCT00471276|Drug|sunitinib|sunitinib (Sutent), 37.5 mg, daily dosing
12016157|NCT00471263|Drug|Casigold|
12016158|NCT00471263|Drug|Casimax|
12016159|NCT00471263|Drug|Placebo|
12016160|NCT00471237|Drug|Ronacaleret|100mg, 200mg, 300mg, 400mg
12016161|NCT00471237|Drug|Teriparatide|PTH (1-34)
12016162|NCT00471237|Drug|Alendronate|Bisphosphonate
12016163|NCT00471224|Other|Observational Trial|No intervention is being used in this study.
12016164|NCT00471211|Drug|PBT2|
12016165|NCT00471185|Drug|Acyline|10, 20 and 40 mg of Oral acyline, given on 3 occasions, separated by 1 week.
12016166|NCT00471172|Behavioral|Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)|
12016167|NCT00471172|Behavioral|Face-to-face counseling by a dietitian (monthly)|
12016168|NCT00471172|Behavioral|Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)|
12016169|NCT00471172|Behavioral|Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)|
12016170|NCT00471172|Behavioral|Self help|
12016171|NCT00471159|Drug|docetaxel|
12016172|NCT00471159|Drug|PF-3512676|
12016173|NCT00471146|Drug|AG-013736|oral administration, starting dose 5 mg twice daily [BID] every day until unacceptable toxicity or tumor progression.
12016174|NCT00471146|Drug|Gemcitabine|intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
12016175|NCT00471146|Drug|Gemcitabine|intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
12016176|NCT00471146|Drug|placebo|placebo
12016177|NCT00471133|Biological|Xenogeneic Tyrosinase DNA Vaccine|
12016178|NCT00471133|Device|TriGrid Delivery System for Intramuscular Electroporation|
12016179|NCT00471120|Other|P2x7 assay|compare P2X7 assay to biopsy
12016180|NCT00471107|Device|DC brain polarization|0.08 mA/cm2
12016181|NCT00471094|Drug|Ilaprazole|Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
12016182|NCT00471094|Drug|Ilaprazole|Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
12016183|NCT00471094|Drug|Ilaprazole|Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
12016184|NCT00471094|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
12016185|NCT00471081|Biological|Meningococcal vaccine GSK134612|One or 2 intramuscular injections.
12016186|NCT00471068|Drug|Travatan|Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
12016187|NCT00471068|Drug|Cosopt|treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
12016188|NCT00471068|Drug|Placebo (Timolol Vehicle)|Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
12016189|NCT00471055|Drug|"0.0125% Capsaicin gel CAPSIKA gel"|
12016190|NCT00471055|Drug|Placebo|Placebo
12016191|NCT00471042|Drug|Buprenorphine|Dose is determined according to the participants' individual need.
12016192|NCT00471029|Drug|esomeprazole|
12016193|NCT00471016|Behavioral|Guided intervention|
12016194|NCT00471003|Drug|Pritor (Telmisartan , BAY68-9291)|Primary care hypertensive patients starting the therapy with Telmisartan
12016195|NCT00470990|Drug|GnRH antagonist (Acyline)|3 Subcutaneous injections (300 mcg/kg) over 36 days
12016196|NCT00470977|Drug|ranibizumab injection (0.5 mg)|ranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months.
12016197|NCT00470964|Procedure|Titanium Sapphire laser trabeculoplasty|
12016198|NCT00470951|Procedure|open rectal resection|open rectal resection
12016199|NCT00470951|Procedure|laparoscopic rectal resection|laparoscopic assisted rectal resection
12016200|NCT00470938|Device|SpineForce Reactive Neuromuscular Trainer|
12016201|NCT00470925|Drug|123-I MZINT injection and SPECT imaging|SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI
12016202|NCT00470912|Drug|sunscreen RV 2547C|
12016203|NCT00470899|Procedure|drainage of placenta of fetal blood|
12016204|NCT00470886|Drug|Telmisartan (Kinzal/Pritor, BAY68-9291)|Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan
12016205|NCT00470873|Drug|Levitra (Vardenafil, BAY38-9456)|Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil
12016206|NCT00470860|Behavioral|Participation in LOFTS online tutorial|
12016207|NCT00470847|Drug|Lapatinib|Orally twice daily
12016208|NCT00470847|Procedure|Whole Brain Radiation|15 treatments over a period of 3 weeks
12016209|NCT00470847|Drug|Herceptin|Herceptin 4mg/kg loading dose then 2 mg/kg IV once weekly, then once every three weeks after cycle 3.
12016210|NCT00470834|Drug|dutasteride|0.5mg dutasteride (Investigation Product)
12016211|NCT00470834|Drug|placebo|making placebo
12016212|NCT00470834|Drug|bicalutamide|50 mg Casodex or generic equivalent
12016213|NCT00470821|Drug|Oral melatonin 3mg BID|Identical tablets containing melatonin 3 mg. Nurses are requested to give two tablets daily, at 8 PM and 12 PM
12016214|NCT00470821|Drug|Placebo|Identical tablets without the active principles. Each evening nurses are requested to give 2 tablets at 8 PM and 12 PM
12016215|NCT00470808|Drug|POMx|
12016274|NCT00470353|Other|immunohistochemistry staining method|
12016275|NCT00470353|Other|laboratory biomarker analysis|
12016216|NCT00470795|Other|Acupuncture|acupuncture treatment (or placebo), 20 minute treatment each; twice weekly for four weeks (total of eight treatments). repeat treatment schedule following crossover (placebo-treatment)
12016217|NCT00470795|Procedure|placebo/sham acupuncture|acupuncture at sham points without skin penetration
12016218|NCT00470769|Procedure|Color-Doppler Ultrasound, 99mTc-DTPA scintigraphy|
12016219|NCT00470756|Other|mechanical triggering of peroneal activity|mechanical triggering of peroneal activity
12016220|NCT00470743|Drug|Ibuprofen|
12016221|NCT00470743|Drug|Indomethacin|
12016222|NCT00470717|Procedure|Weekly telephone call|Details of feeding and health/sickness will be obtained
12016223|NCT00470704|Drug|Lapatinib|Oral dose taken daily
12016224|NCT00470704|Drug|Herceptin|Given intravenously once a week or once every 3 weeks
12016225|NCT00470691|Procedure|plaster cast|complete circular plaster cast
12016226|NCT00470691|Procedure|dorsal splint|dorsal plaster splint
12016227|NCT00470678|Drug|ranibizumab|
12016228|NCT00470665|Drug|Rapamune|
12016229|NCT00470652|Device|computer-assisted decision support|at the end of the pre-intervention period, the patient flow software was modified to open popup windows automatically when pain intensity was not documented or pain was not reevaluated within the recommended interval. The popup window also detailed appropriate pain treatment guidelines based on the documented pain intensity. In addition, the patient's icon in the flow software changed from black to red when pain intensity was >4/10. After a 10-day test period, the post-intervention data collection started.
12016230|NCT00470639|Device|Transcranial Magnetic Stimulation|
12016231|NCT00470626|Device|Celect Vena Cava Filter|Effective filtration of inferior vena cava blood to prevent thromboembolism.
12016232|NCT00470613|Genetic|SGT-53|For Phase Ib: SGT-53 (2.4 mg DNA per infusion) will be administered in combination with docetaxel at 40 mg/m2 starting dose, cohort 1, cycle 1. SGT-53 will be administered weekly, on day 1 in weeks 2, 3, 5, and 6, and biweekly on days 1 and 4 in weeks 1, 4, and 7. Docetaxel will be administered every 3 weeks (weeks 1, 4, and 7)on day 3. Patients completing cohort 1, cycle 1 without DLT at 40 mg/m2 docetaxel will be allowed to dose escalate to 60 mg/m2 docetaxel in cycles 2 and 3.Cohort 2 (2.4mg DNA/infusion;75mg/m2 Docetaxel) will open 3 weeks after demonstration of 0/3 or ≤1/6 DLTs at docetaxel 60 mg/m2. Cohort 3 (3.6 mg DNA/infusion; 75 mg/m2 Docetaxel) will open after demonstration of 0/3 or ≤1/6 DLTs at SGT-53 2.4 mg DNA/infusion and docetaxel 75 mg/m2.
12016233|NCT00470600|Drug|Caldolor|800 milligrams intravenous
12016234|NCT00470600|Other|Normal Saline|Placebo comparator
12016235|NCT00470574|Biological|QS21|
12016236|NCT00470574|Biological|sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine|
12016237|NCT00470574|Other|immunoenzyme technique|
12016238|NCT00470574|Other|immunologic technique|
12016239|NCT00470574|Other|laboratory biomarker analysis|
12016240|NCT00470561|Drug|Aspirin|Two 325 mg doses of aspirin per day for 6 months
12016241|NCT00470561|Drug|Placebo|Two placebo pills per day for 6 months
12016242|NCT00470548|Drug|Abraxane|ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)
12016243|NCT00470548|Drug|Alimta|Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)
12016244|NCT00470535|Drug|erlotinib hydrochloride|Oral
12016245|NCT00470535|Other|immunohistochemistry staining method|Correlative Study
12016246|NCT00470535|Other|laboratory biomarker analysis|Correlative Study
12016247|NCT00470522|Drug|Methotrexate and folic acid|
12016248|NCT00470509|Drug|Adalimumab|2 subcutaneous injections on day 0 and 7
12016249|NCT00470509|Drug|Placebos|2 subcutaneous injections on day 0 and 7
12016250|NCT00470496|Drug|HPPH|Given IV
12016251|NCT00470496|Drug|photodynamic therapy|Undergo laser light exposure
12016252|NCT00470496|Procedure|conventional surgery|Undergo surgery
12016253|NCT00470483|Drug|Placebo treatment during 8 weeks|comparator
12016254|NCT00470483|Drug|Paroxetine treatment during 8 weeks|treatment drug
12016255|NCT00470470|Drug|imatinib mesylate|Given orally
12016256|NCT00470470|Other|laboratory biomarker analysis|Correlative studies
12016257|NCT00470457|Biological|Allergen specific immunotherapy|
12016258|NCT00470444|Procedure|Transfusion with Red Blood Cells|Units of donated Red blood cells
12016259|NCT00470444|Biological|1 unit of donated red blood cells|Units of red blood cells
12016260|NCT00470444|Biological|1 unit of donated red blood cells|Units of donated red blood cells
12016261|NCT00470418|Drug|NIC5-15|a natural product, found in many foods and plants with mild insulin sensitizing effects
12016262|NCT00470418|Drug|Placebo|placebo comparator
12016263|NCT00470405|Drug|oxaliplatin|75-100 mg/m2 iv infusion Approximately 2 hours beginning approximately 30 minutes after the end of ALIMTA infusion on Day 1 of a 14-days cycle
12016264|NCT00470405|Drug|pemetrexed disodium|a novel antifolate with multiple targets.
12016265|NCT00470392|Drug|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
12016266|NCT00470392|Drug|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
12016267|NCT00470379|Drug|resiquimod|Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.
12016268|NCT00470366|Biological|pegfilgrastim|
12016269|NCT00470366|Drug|cisplatin|
12016270|NCT00470366|Drug|ifosfamide|
12016271|NCT00470366|Drug|paclitaxel|
12016272|NCT00470353|Dietary Supplement|calcium carbonate|
12016273|NCT00470353|Dietary Supplement|cholecalciferol|
12016276|NCT00470353|Other|pharmacological study|
12016277|NCT00470353|Procedure|biopsy|
12016278|NCT00470340|Drug|Oxaliplatin, gemcitabine, cisplatin, lipiodol|Oxaliplatin, gemcitabine, cisplatin, lipiodol
12016279|NCT00470314|Drug|L-Ornithine L-Aspartate|
12016280|NCT00470301|Drug|tipifarnib|Given orally
12016281|NCT00470301|Drug|paclitaxel|Given IV
12016282|NCT00470301|Drug|doxorubicin|Given IV
12016283|NCT00470301|Drug|cyclophosphamide|Given IV
12016284|NCT00470288|Procedure|bladder flap during cesarean section|
12016285|NCT00470275|Drug|cytarabine|Given IV
12016286|NCT00470262|Drug|Fenofibrate 145mg PO QD|Subjects will be randomized to either fenofibrates or combination of both fenofibrate and pioglitazone
12016287|NCT00470262|Drug|Pioglitazone 45 mg PO QD|Subjects will be randomized to either fenofibrate 145 mg PO QD or a combination of both fenofibrate 145 mg PO QD and pioglitazone 45 mg PO QD
12016288|NCT00470249|Drug|Carboplatin|At a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 of every 2-week cycle
12016289|NCT00470249|Drug|Gemcitabine Hydrochloride|1500 mg/m2 on day 2 of every 2-week cycle
12016290|NCT00470236|Radiation|Standard WB fractionation|A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
12016291|NCT00470236|Radiation|Shorter WB fractionation|A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
12016292|NCT00470236|Radiation|Standard WB fractionation+Boost|"Whole Breast: A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
~Tumour bed: A total dose of 10 Gy in 5 fractions in 2-Gy daily fractions, 5 fractions per week."
12016293|NCT00470236|Radiation|Shorter WB fractionation + Boost|"Whole breast: A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
~Tumour bed: A total dose of 10 Gy in 4 fractions in 2.5-Gy daily fractions, 4 fractions per week."
12016294|NCT00470223|Drug|cisplatin|
12016295|NCT00470223|Drug|doxorubicin hydrochloride|
12016296|NCT00470223|Drug|etoposide|
12016297|NCT00470223|Drug|ifosfamide|
12016298|NCT00470223|Drug|methotrexate|
12016299|NCT00470223|Drug|zoledronic acid|
12016300|NCT00470223|Procedure|conventional surgery|
12016301|NCT00470210|Drug|Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week|Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
12016302|NCT00470210|Drug|Ribavirin (Copegus®) 1600 mg/day|Ribavirin (Copegus®) 1600 mg/day
12016303|NCT00470210|Drug|Epoetin β (450 UI/kg/week)|Epoetin β (450 UI/kg/week)
12016304|NCT00470197|Drug|alvocidib|Given IV
12016305|NCT00470197|Drug|cytarabine|Given IV
12016306|NCT00470197|Drug|mitoxantrone hydrochloride|Given IV
12016307|NCT00470197|Other|pharmacological study|Correlative study
12016308|NCT00470184|Drug|capecitabine|Oral
12016309|NCT00470184|Drug|oxaliplatin|IV
12016310|NCT00470184|Genetic|gene expression analysis|Correlative Study
12016311|NCT00470184|Genetic|microarray analysis|Correlative Study
12016312|NCT00470184|Genetic|reverse transcriptase-polymerase chain reaction|Correlative Study
12016313|NCT00470184|Procedure|adjuvant therapy|Metastatic growth control
12016314|NCT00470184|Procedure|biopsy|Examination of tissue type
12016315|NCT00470184|Procedure|conventional surgery|Tissue removal
12016316|NCT00470184|Procedure|neoadjuvant therapy|Tumor shrinkage
12016317|NCT00470184|Procedure|quality-of-life assessment|Correlative Study
12016318|NCT00470184|Radiation|radiation therapy|Undergoing radiation therapy
12016319|NCT00470171|Drug|Ursodesoxycholic acid|
12016320|NCT00470158|Dietary Supplement|iron and zinc combined|Children >= 12 months received an average of 5mg zinc/day, 6.25 Iron/day, and 25IU folic acid/day. children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
12016321|NCT00470158|Dietary Supplement|iron and zinc on separate days|Children >= 12 months received an average of 5mg zinc/day, alternating daily with 6.25 Iron/day, and 25IU folic acid/day. Children<12 received half that dose. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
12016322|NCT00470158|Dietary Supplement|iron|Children >= 12 months received an average 6.25 Iron/day, and 25IU folic acid/day. Children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
12016323|NCT00470158|Dietary Supplement|Zinc|Children >= 12 months received an average of 5mg zinc/day. Children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
12016324|NCT00470158|Dietary Supplement|placebo|Children received daily placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
12016325|NCT00470145|Drug|SB-568859|
12016326|NCT00470119|Behavioral|behavioral dietary intervention|A group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss
12016327|NCT00470119|Behavioral|Exercise intervention|Facility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week
12016328|NCT00470106|Behavioral|Cognitive remediation|Computer exercises in attention, memory, and speed of processing.
12016329|NCT00470106|Behavioral|Social Cognitive skills training|Group training on emotion perception, social perception, and understanding others' mental states.
12016330|NCT00470106|Behavioral|hybrid intervention|A combination of the two groups listed above.
12016331|NCT00470106|Behavioral|skills training|Skills training in how to identify symptoms of illness and medication side effects.
12016332|NCT00470093|Biological|recombinant interferon-α|
12016333|NCT00470093|Biological|recombinant interleukin-6|
12016334|NCT00470080|Procedure|venepuncture|venepuncture
12016335|NCT00470067|Drug|carboplatin|IV
12016336|NCT00470067|Drug|pegylated liposomal doxorubicin hydrochloride|IV
12016337|NCT00470054|Drug|dasatinib|Given PO
12016338|NCT00470041|Drug|administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation|
12016339|NCT00470028|Device|Transcranial Magnetic Stimulation|
12016340|NCT00470015|Biological|MART-1 antigen|1000 mcg; Day 1 of a 21 day cycle x 4
12016341|NCT00470015|Biological|IL-2|0.5x10^6/m^2
12016342|NCT00470015|Biological|gp100 antigen|1000 mcg; Day 1 of a 21 day cycle x 4
12016343|NCT00470015|Biological|GM-CSF|300mcg
12016344|NCT00470015|Biological|MART-1a peptide|1000 mcg; Day 1 of a 21 day cycle x 4
12016345|NCT00470002|Drug|Somatropin|
12016346|NCT00469989|Procedure|Infection with hookworm larvae|
12016347|NCT00469976|Drug|bevacizumab|
12016348|NCT00469976|Drug|carboplatin|
12016349|NCT00469976|Drug|enzastaurin hydrochloride|
12016350|NCT00469976|Drug|gemcitabine hydrochloride|
12016351|NCT00469963|Procedure|quality-of-life assessment|quality-of-life assessment
12016352|NCT00469963|Radiation|yttrium Y 90 resin microspheres|radiation therapy
12016353|NCT00469950|Behavioral|exercise training|Exercise training in groups
12016354|NCT00469937|Drug|lithium carbonate|Dose levels Neoadjuvant lithium Concurrent lithium Dose level -1 300mg po QD 300mg po QD Dose level (starting dose) 300mg po BID 300mg po BID Dose level 2 300mg po TID 300mg po TID Dose level 3 300mg po QID 300mg po QID
12016355|NCT00469937|Procedure|cognitive assessment|cognitive assessment
12016356|NCT00469937|Procedure|quality-of-life assessment|quality-of-life assessment
12016357|NCT00469937|Radiation|radiation therapy|Protocol radiotherapy must begin within seven days following initiation of Lithium therapy if day seven falls on a holiday or weekend; it is acceptable to begin treatment the next business day. One treatment of 3Gy will be given daily with the exception of weekends and holidays for a total of (10 fractions) for a total of 30 Gy over 2 to 3 weeks.
12016358|NCT00469924|Procedure|Real Time Clinical Alerting|
12016359|NCT00469911|Procedure|Magnetic Resonance Spectroscopy|Magnetic Resonance Spectroscopy is a noninvasive procedure that provides detailed body images on any plane.
12016360|NCT00469911|Procedure|Ex vivo heart biopsy|Heart transplant patients will have their normal clinical routine heart biopsy
12016361|NCT00469898|Drug|Carboplatin|"Carboplatin dosage calculation to be given on day 1, every 21 days:
~Carboplatin (mg) = (AUC of 5) x (GFR + 25)
~*up to 6 cycles at physician's discretion"
12016362|NCT00469898|Drug|irinotecan hydrochloride|"50 mg/m2 IV on days 1 and 8 every 21 days
~Should be infused IV over 30- 90 minutes."
12016363|NCT00469885|Drug|Nicotine replacement|For reduction
12016364|NCT00469885|Behavioral|Motivational counseling|No drugs
12016365|NCT00469872|Procedure|Context-focused compared to child-focused interventions|
12016366|NCT00469859|Drug|cytarabine|given IV
12016367|NCT00469859|Drug|idarubicin|Given IV
12016368|NCT00469859|Drug|lestaurtinib|Given orally
12016369|NCT00469846|Procedure|L-arginine supplementation in a medical food|
12016370|NCT00469846|Procedure|Vitamin C and E supplementation in a medical food|
12016371|NCT00469833|Drug|insulin glargine|Diabetic subjects will be treated with insulin glargine once daily for 2 months. Subjects will monitor their blood glucose and have their insulin dose adjusted in steps of 4-6 units to achieve a goal of less than or equal to 120 mg/dl for fasting blood glucose.
12016372|NCT00469820|Biological|autologous tumor cell vaccine|
12016373|NCT00469820|Biological|peripheral blood lymphocyte therapy|
12016374|NCT00469794|Procedure|stress test|
12016375|NCT00469781|Drug|2. Xibrom (Bromfenac)|Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.
12016376|NCT00469781|Drug|1. Pred Forte|"Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks.
~Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks."
12016377|NCT00469768|Drug|dapivirine reservoir intravaginal ring|a silicone elastomer reservoir ring containing 25mg of dapivirine
12016378|NCT00469768|Drug|dapivirine matrix intravaginal ring|a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
12016379|NCT00469768|Other|placebo intravaginal ring|a silicone elastomer intravaginal ring containing no dapivirine
12016380|NCT00469755|Drug|Adapalene Gel, 0.1%|Apply once daily in the evening for 12 weeks
12016381|NCT00469755|Drug|Tazarotene Cream, 0.1%|Apply once daily in the evening for 12 weeks
12016382|NCT00469755|Drug|Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%|Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks
12016383|NCT00469729|Drug|StemEx®|The stem/progenitor cell based product composed of ex vivo expanded allogeneic umbilical cord blood cells, which is infused to subject at a rate of 1-3 ml/min in combination with non-manipulated cells derived from the same cord blood unit.
12016384|NCT00469716|Drug|Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)|
12016385|NCT00469703|Drug|Thalidomide|
12016386|NCT00469690|Drug|Acular, Xibrom|"Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am)
~Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)"
12016387|NCT00469664|Drug|Guanfacine/Tenex|
12016388|NCT00469651|Biological|MSP 3 Long Synthetic Peptide|Lyophilized MSP3 vaccine adjuvanted in Aluminium hydroxide
12016389|NCT00469651|Biological|MSP3 vaccine|Lyophilized vaccine adjuvanted in Aluminium hydroxide
12016390|NCT00469651|Biological|Hepatitis B vaccine|Hepatitis B vaccine adjuvanted in Aluminium hydroxide
12016391|NCT00469651|Biological|MSP3 candidate vaccine|Lyophilized MSP3 adjuvanted in Aluminium hydroxide
12016509|NCT00468702|Device|CoaguChek S|
12016392|NCT00469651|Biological|Hepatitis B control vaccine|Hepatitis B vaccine adjuvanted in Aluminium Hydroxide
12016393|NCT00469638|Procedure|Left atrial catheter ablation guided by introducer using Agilis sheeth|Left atrial catheter ablation guided by introducer using Agilis sheeth
12016394|NCT00469638|Procedure|Left atrial catheter ablation guided by introducer using Non-steerable sheeth|Left atrial catheter ablation guided by introducer using Non-steerable sheeth
12016395|NCT00469625|Drug|paricalcitol (initial dose 1 mcg orally per day)|
12016396|NCT00469612|Device|NeuroVision's NVC treatment for Low Myopia|"NeuroVision's NVC vision correction technology is a method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex (area responsible for vision in the brain).
~The subject will be exposed to a set of visual stimulations (pattern with black and white lines) and visual threshold level will be obtained. The subject will look at these patterns on a computer. The treatment will be applied in successive 30-40 minute sessions, administered 2-3 times a week, for a total of 40 sessions. Every 5 sessions, subject's visual performance (visual acuity and CSF) will be tested in order to continuously monitor a subject's progress."
12016397|NCT00469599|Drug|paricalcitol|3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate
12016398|NCT00469599|Drug|alfacalcidol|1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.
12016399|NCT00469586|Drug|inhaled human insulin|Treat-to-target dose titration scheme, pre-prandial, inhalation.
12016400|NCT00469586|Drug|metformin|Tablets, 2000 mg/day.
12016401|NCT00469586|Drug|glimepiride|Tablets, 4 mg/day.
12016402|NCT00469586|Drug|inhaled human insulin|Treat-to-target dose titration scheme, post-prandial, inhalation.
12016403|NCT00469573|Drug|1. Optive|Optive 15ml- (in the eye) Instill one drop twice daily in each eye
12016404|NCT00469560|Drug|Deferasirox|
12016405|NCT00469547|Other|62% ethanol in emollient gel|62% ethanol in emollient gel used as a topical male microbicide
12016406|NCT00469547|Drug|Placebo|15% ethanol in emollient gel used as a topical male microbicide
12016407|NCT00469547|Other|15% ethanol in emollient gel|15% ethanol in emollient gel used as a topical male microbicide
12016408|NCT00469534|Procedure|IMRT|
12016409|NCT00469521|Drug|Refresh Tears, 9582X|
12016410|NCT00469508|Drug|Modafinil|400mg pills taken orally daily for 12 wks.
12016411|NCT00469508|Drug|Placebo|400mg pills taken orally daily for 12 wks
12016412|NCT00469495|Drug|Anti-helminthic|
12016413|NCT00469495|Drug|meglumine antimony|
12016414|NCT00469482|Other|Sedation,RASS Targeted plus BIS Monitoring|Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring
12016415|NCT00469482|Other|Sedation, RASS Targeted|Patient sedation utilizing standard of care methods (RASS targeted)
12016416|NCT00469469|Drug|Bevacizumab|
12016417|NCT00469456|Drug|Memantine|Memantine 20mg (10mg twice daily) oral administration for 12 weeks
12016418|NCT00469456|Drug|placebo|Placebo oral administration twice daily for 12 weeks
12016419|NCT00469443|Drug|Irinotecan|Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
12016420|NCT00469443|Drug|5-Fluorouracil|5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
12016421|NCT00469443|Drug|Leucovorin|Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
12016422|NCT00469443|Drug|Capecitabine|Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
12016423|NCT00469443|Drug|Bevacizumab|Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
12016424|NCT00469443|Drug|Bevacizumab|Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
12016425|NCT00469443|Drug|Irinotecan|Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
12016426|NCT00469430|Drug|cefotaxim and metronidazol|iv administration for at least 24 h
12016427|NCT00469417|Procedure|Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream|
12016428|NCT00469404|Drug|Buprenorphine|
12016429|NCT00469391|Device|GI Sleeve Implantable weight loss device (EndoBarrier)|device for weight loss
12016430|NCT00469391|Procedure|Sham Procedure|Weight loss
12016431|NCT00469378|Drug|firategrast|900 (females) or 1200 (males) mg twice daily for 24 weeks
12016432|NCT00469365|Behavioral|pharmacist contact with the patient via telephone|
12016433|NCT00469365|Behavioral|Pharmacist contact with the patient's physician via fax|
12016434|NCT00469365|Behavioral|Usual care|
12016435|NCT00469352|Drug|Ranibizumab|Ranibizumab as needed
12016436|NCT00469326|Drug|Atorvastatin|two days 80mg atorvastatin pre-treatment before PCI
12016437|NCT00469300|Drug|Iontophoretic delivery of acyclovir|
12016438|NCT00469274|Drug|Antibiotic PEP|Azithromycin 1000mg po x 1, then 500mg po Q day for 4 days; TMP-SMX DS one BID for 14 days
12016439|NCT00469274|Drug|Antibiotic PEP|TMP-SMX DS po BID for 14 days
12016440|NCT00469261|Drug|Doxycycline|Doxycycline 100 mg bid for seven days after enrollment
12016441|NCT00469261|Drug|Current medical therapy for AMI|Current medical therapy for AMI
12016442|NCT00469248|Device|Intra-aortic balloon pump counterpulsation|
12016443|NCT00469235|Drug|Avotermin|"10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.
~10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure."
12016444|NCT00469222|Procedure|hypofractionated external beam|
12016445|NCT00469209|Drug|Trisenox (Arsenic Trioxide)|0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
12016510|NCT00468689|Drug|SB-751689 oral tablets (100 and 400 ng)|
12016511|NCT00468689|Drug|Ketoconazole (NIZORAL) oral tablets (200 mg)|
12016446|NCT00469209|Drug|Velcade (Bortezomib)|"Arm 1 (Level 1):
~1.0 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
~Arm 2 (Level 2):
~1.5 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute)."
12016447|NCT00469209|Drug|Melphalan|100 mg/m2 by vein days -4,-3, over 30 minutes
12016448|NCT00469209|Drug|Vitamin C (Ascorbic Acid)|1000 mg once a day through the vein for 7 days.
12016449|NCT00469196|Procedure|Tomotherapy|40 Gy in 15 fractions, at one fraction per day. Dose will be prescribed to the 95% isodose line.
12016450|NCT00469183|Drug|Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%|Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses
12016451|NCT00469170|Device|intravaginal ring|silicone elastomer intravaginal ring containing no drug product
12016452|NCT00469157|Drug|Optive|Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery
12016453|NCT00469144|Drug|Busulfan|"Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days.
~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day.
~Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
12016454|NCT00469144|Drug|Fludarabine|40 mg/m^2 IV Daily Over 1 Hour x 4 Days
12016455|NCT00469131|Drug|tacrolimus + steroid|
12016456|NCT00469131|Drug|tacrolimus + mycophenolate mofetil|
12016457|NCT00469118|Device|DRX9000™|Nonsurgical spinal decompression
12016458|NCT00469105|Behavioral|Literacy/Numeracy oriented educational intervention|Receives comprehensive literacy/num sensitive diabetes care
12016459|NCT00469105|Behavioral|Control Group|Receives standard diabetes disease management
12016460|NCT00469092|Drug|biphasic insulin aspart|Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
12016461|NCT00469092|Drug|insulin glargine|Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
12016462|NCT00469092|Drug|metformin|Tablets, 2550 mcg. Administered once daily.
12016463|NCT00469092|Drug|glimepiride|Tablets 2 mg. 4, 6 or 8 mg administered once daily.
12016464|NCT00469079|Drug|Nicotine gum and lozenge|Nicotine replacement
12016465|NCT00469079|Other|Taboka|smokeless tobacco product
12016466|NCT00469079|Other|Camel Snus|smokeless tobacco product
12016467|NCT00469053|Drug|Buprenorphine|
12016468|NCT00469040|Drug|GW642444M for 14 days|M salt
12016469|NCT00469027|Biological|eNOS transfected EPCs will be delivered via a PA line|incremental dosing over 3 days
12016470|NCT00469014|Drug|Clofarabine|Arm 1 = 10 mg/m^2 intavenous (IV) Daily; Arm 2 = 20 mg/m^2 IV Daily; Arm 3 = 30 mg/m^2 IV Daily; Arm 4 = 40 mg/m^2 IV Daily
12016471|NCT00469014|Drug|Busulfan|Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily; Arm 4: 40 mg/m^2 IV Daily
12016472|NCT00469014|Drug|Fludarabine|Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily
12016473|NCT00469001|Procedure|Treatment according NT Pro BNP level|
12016474|NCT00468988|Drug|Travatan® Z|
12016475|NCT00468988|Drug|Xalatan®|
12016476|NCT00468975|Drug|PF-610,355|
12016477|NCT00468975|Drug|Salmeterol|
12016478|NCT00468962|Drug|FACOS (functional food)|
12016479|NCT00468936|Drug|Myfortic|enteric coated Cellcept pills in applicable dose for patient
12016480|NCT00468923|Drug|Candesartan/HCT|Candesartan 16 mg/HCT 12.5 once daily
12016481|NCT00468923|Drug|Rosuvastatin|Rosuvastatin 10 mg once daily
12016482|NCT00468910|Drug|acetylsalicylic acid|Given orally
12016483|NCT00468910|Drug|placebo|Given orally
12016484|NCT00468910|Other|laboratory biomarker analysis|Correlative study
12016485|NCT00468897|Drug|RSG XR|RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water.
12016486|NCT00468884|Drug|Increasing doses of GLP-1|
12016487|NCT00468884|Drug|PYY3-36|
12016488|NCT00468871|Drug|fluocinolone acetonide intravitreal implant|surgical intravitreal implant of fluocinolone acetonide
12016489|NCT00468871|Drug|corticosteroids and immunosuppressants|Systemic corticosteroids alone or combined with immunosuppressants
12016490|NCT00468858|Other|Placebo|"Lyophilized, single dose vials and sterile water for
~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
12016491|NCT00468858|Biological|T-DEN-Post-Transfection F17|Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
12016492|NCT00468858|Biological|T-DEN-Post-Transfection F19|Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
12016493|NCT00468845|Drug|pregabalin (Lyrica)|150 mg/day double blind (divided doses)
12016494|NCT00468845|Drug|pregabalin (Lyrica)|300 mg/day double blind (divided doses)
12016495|NCT00468845|Drug|matched placebo|matched placebo
12016496|NCT00468819|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
12016497|NCT00468806|Drug|GSK598809, using [11C]-(+)-PHNO|
12016498|NCT00468793|Procedure|Intravenous fluid|The same intravenous fluids will be used in both arms but the volume will be different
12016499|NCT00468767|Drug|Vernakalant Injection 20 mg/mL|
12016500|NCT00468754|Device|Insulin pumps|
12016501|NCT00468741|Behavioral|CHESS (Comprehensive Health Enhancement Support System)|Full CHESS for subject use
12016502|NCT00468741|Behavioral|CHESS|informational services of CHESS available to subject
12016503|NCT00468741|Behavioral|CHESS|CHESS informational services and social support available to subject
12016504|NCT00468728|Drug|PAR-101/OPT-80|capsules
12016505|NCT00468728|Drug|Vancomycin|Capsules
12016506|NCT00468715|Drug|bicalutamide|
12016507|NCT00468715|Other|diagnostic laboratory biomarker analysis|
12016508|NCT00468715|Other|immunohistochemistry staining method|
12016512|NCT00468676|Behavioral|Nurse-led case management|The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.
12016513|NCT00468676|Behavioral|Treatment as usual|Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.
12016514|NCT00468650|Drug|sildenafil citrate|Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.
12016515|NCT00468624|Drug|pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks|
12016516|NCT00468624|Procedure|GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo)|
12016517|NCT00468624|Procedure|blood sampling before and after pegvisomant/placebo|
12016518|NCT00468624|Procedure|arginine stimulation test after each limb|
12016519|NCT00468611|Drug|MBP8298|500mg MBP8298 IV every six months for a period of two years
12016520|NCT00468585|Drug|Capecitabine|
12016521|NCT00468585|Drug|Bevacizumab|
12016522|NCT00468572|Behavioral|Affectionate Writing|Participants assigned to the experimental group will spend 20 minutes writing an affectionate letter to a loved one. Levels of cortisol will be measured using saliva samples from each participant during the writing session. Levels of oxytocin, a hormone known to transmit signals within the brain and often associated with bonding and building trusting relationships, will be measured from blood samples taken during the writing session as well.
12016523|NCT00468572|Behavioral|Meaningless Writing|Participants assigned to the control group will spend 20 minutes writing about meaningless topics. Participants will undergo the same testing during the writing session as the experimental group.
12016524|NCT00468559|Drug|Open Label Run In Esomeprazole|Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
12016525|NCT00468559|Drug|Double Blind Esomeprazole|Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
12016526|NCT00468559|Drug|Double Blind Placebo|Double Blind Placebo
12016527|NCT00468546|Drug|MabThera/Rituxan|1
12016528|NCT00468546|Drug|Methotrexate|2
12016529|NCT00468546|Other|Placebo|3
12016530|NCT00468533|Drug|Aripiprazole|
12016531|NCT00468520|Drug|low dose oxytocin|
12016532|NCT00468507|Dietary Supplement|nutritional intervention with Respifor and Diasip|Four nutritional interventions on four separate days per test person
12016533|NCT00468481|Drug|Drospirenone/Ethinylestradiol/Methyltetrahydrofolate|0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)
12016534|NCT00468481|Drug|Drospirenone/Ethinylestradiol (Yaz)|0.020 mg ethinylestradiol with 3.0 mg drospirenone
12016535|NCT00468468|Behavioral|CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor|computer based education and support
12016536|NCT00468455|Procedure|Laparoscopic or open colorectal surgery|Application of a post-operative diary to be completed by subjects. The intervention is standard of care laparoscopic or open surgery.
12016537|NCT00468442|Biological|Allogeneic Pancreatic Islet Cells|transplant of islet cells injected into the portal vein of the liver
12016538|NCT00468442|Biological|Antithymocyte globulin|Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
12016539|NCT00468442|Biological|Daclizumab|Will replace antithymocyte globulin in all islet transplantations after the first one
12016540|NCT00468442|Biological|Rituximab|Depletes transient B-cells
12016541|NCT00468442|Drug|Sirolimus|Maintenance immunosuppressive therapy
12016542|NCT00468429|Drug|Subconjunctival Bevacizumab|
12016543|NCT00468416|Device|Compression Anastomosis Ring (CAR)|
12016544|NCT00468403|Biological|Allogeneic Pancreatic Islet Cells|Transplant of islet cells from a healthy pancreas. A dose of at least 5,000 Islet Equivalents (IEQ)/kg recipient body weight (BW) infused intraportally for the first transplant, and at least 4,000 IEQ/kg recipient BW infused intraportally for subsequent transplants.
12016545|NCT00468403|Biological|Belatacept|Belatacept is an inhibitor of the 2 signals that stimulate T-cells. Subjects will receive NULOJIX® (belatacept)10mg/kg through a peripheral vein on Day 0 and post-operative days 4, 14, 28, 56, 84. After Day 84 subjects will receive belatacept at a maintenance dose of 5 mg/kg every 4 weeks for the duration of study follow-up (2 years after the final islet transplant). Infusion doses will be based upon the subject's actual body weight at study Day 0 and will not be modified during the course of the study unless there is a change in body weight plus or minus 10% of Day 0 body weight.
12016546|NCT00468403|Biological|Basiliximab|Immunosuppressive medication for prophylaxis of acute transplant rejection. Two Intravenous (IV) doses of basiliximab, a monoclonal antibody Interleukin 2 (IL-2) receptor blocker, will be given with the first and second (if necessary) transplants. The first dose will be 20 mg and will be given within two hours prior to islet transplant on the day of islet transplantation. The second 20 mg dose will be given on Day 4 after the transplant.If a third islet transplant is deemed necessary and performed more than 70 days after the second transplant, both doses of basiliximab will be repeated. No additional doses of basiliximab will be given with a third transplant that is performed between 30 and 70 days after the second transplant.
12016547|NCT00468403|Drug|Mycophenolate Mofetil|Maintenance immunosuppressive therapy. Subjects will receive mycophenolate mofetil starting immediately pre-transplant on Day 0 at a dose of 1g orally twice a day for the duration of study follow-up (2 years after the final islet transplant).
12016548|NCT00468403|Drug|Tacrolimus|Tacrolimus may be used only as a supplement to maintenance mycophenolate mofetil (MMF) in those cases where the trough level is below the therapeutic range. Tacrolimus will be administered orally twice a day to maintain trough levels of 3-5 ng/mL. Generic equivalents of Prograf® will not be permitted.
12016774|NCT00466752|Procedure|needle biopsy|Correlative studies
12016549|NCT00468403|Procedure|Intraportal infusion of islet cells|The infusion of allogeneic pancreatic islet cells (islet transplant[s]) will occur intraportally.
12016550|NCT00468364|Drug|insulin glargine|
12016551|NCT00468364|Drug|NPH insulin|
12016552|NCT00468351|Procedure|Intravitreal Injection of 1,5 mg of bevacizumab|
12016553|NCT00468351|Procedure|Intravitreal injection of 4 mg of Triamcinolone acetonide|
12016554|NCT00468338|Device|BIS monitor|BIS monitor measures the depth of anesthesia and was used in the entire group
12016555|NCT00468325|Procedure|Multi-slice computed tomography|Patient receives a CT scan (multi-slice computed tomography) of the heart.
12016556|NCT00468325|Procedure|Rest-stress Nuclear Myocardial Perfusion Imaging|Patient receives the standard of care for emergency room admitting diagnosis of low to intermediate chest pain. A rest-stress nuclear myocardial perfusion imaging test is performed per the standard of care at each institution.
12016557|NCT00468325|Procedure|Multi-slice Computed Tomography|Patients admitted to the emergency department with low to intermediate chest pain receive a multi-slice computed tomographic test of the heart.
12016558|NCT00468312|Drug|Mometasone furoate nasal spray|Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning
12016559|NCT00468312|Drug|Placebo|Two sprays in each nostril in the morning
12016560|NCT00468299|Drug|Misoprostol and placebo|Women in this group receive 800 mcg misoprostol plus a placebo
12016561|NCT00468299|Drug|Mifepristone and misoprostol|This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally
12016562|NCT00468286|Drug|Degarelix|"Experimental
~Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months."
12016563|NCT00468286|Drug|Degarelix|"Experimental
~Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months."
12016564|NCT00468273|Drug|Immune Globulin Intravenous (Human) Omr-IgG-am IGIV|IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
12016565|NCT00468260|Drug|Patupilone|
12016566|NCT00468247|Device|Navigator|Navigator circulatory mgt system
12016567|NCT00468247|Other|Conventional care|Conventional haemodynamic care
12016568|NCT00468234|Drug|nicotine polacrilex|
12016569|NCT00468234|Drug|nicotine transdermal system|
12016570|NCT00468234|Drug|nicotine inhaler|
12016571|NCT00468221|Drug|Ozone Exposure|Low dose ozone exposure in chamber
12016572|NCT00468208|Drug|Abatacept|"A participant's abatacept dose depended on body weight and will remain the same throughout the study:
~500 mg of abatacept for body weight less than 60 kg
~750 mg of abatacept for body weight between 60 and 100 kg
~1000 mg of abatacept for body weight greater than 100 kg
~Abatacept is administered in a 30-minute intravenous infusion."
12016573|NCT00468182|Drug|Interferon-beta 1b (Betaseron)|Treatment of patients with FDA-approved Rx
12016574|NCT00468169|Drug|Cetuximab|250mg/m2(day 1, weekly x 10);
12016575|NCT00468169|Drug|5-FU|600 mg/m2/day; days 0-5 (120 h total) every other week x 5
12016576|NCT00468169|Drug|Hydroxyurea|500 mg PO BID, days 0-5 every other week x 5
12016577|NCT00468169|Radiation|Twice-daily radiation|150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
12016578|NCT00468169|Drug|Cisplatin|100 mg/m2, week 1 and 4 on day 1 (or 2)
12016579|NCT00468169|Radiation|Accelerated fraction radiotherapy with concomitant boost|72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
12016580|NCT00468156|Behavioral|written materials only|related to fruit/vegetable servings/day
12016581|NCT00468156|Behavioral|written materials|related to fruit/vegetable servings/day
12016582|NCT00468156|Behavioral|telephone support|related to fruit/vegetable servings/day
12016583|NCT00468143|Drug|Adderall ® Immediate Release|Adderall Immediate release (IR) was provided as treatment for three weeks (at 15, 30 or 45 mg TID). The medication was optimized for titration.
12016584|NCT00468143|Drug|Adderall XR ®|Adderall Extended Release (XR) was provided as treatment for three weeks at (15, 30, or 45 mg QD). The medication was optimized for titration.
12016585|NCT00468130|Drug|Aripiprazole|Subjects under 40 kg will be started on 2.5mg per day of aripiprazole or placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects
12016586|NCT00468117|Procedure|Islet transplantation|
12016587|NCT00468117|Biological|Antithymocyte Globulin|Participants will begin receiving ATG 2 days prior to the initial islet transplant and will continue to receive ATG until Day 2 post-transplant.
12016588|NCT00468117|Biological|Daclizumab or Basiliximab|Daclizumab or Basiliximab will be used for subsequent transplants.
12016589|NCT00468117|Biological|Etanercept|Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
12016590|NCT00468117|Biological|Allogenic human purified pancreatic islets|200 ml suspension of allogenic human purified islets
12016591|NCT00468104|Drug|Alteplase|25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days
12016592|NCT00468104|Drug|Placebo|Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days
12016593|NCT00468091|Drug|exendin(9-39)amide|
12016594|NCT00468091|Drug|atropine|
12016595|NCT00468078|Procedure|PET/CT|10min acquisition, 90min after injection of F-18 FPCIT
12016596|NCT00468078|Drug|F-18 FPCIT|5mCi, intravenous injection
12016597|NCT00468065|Device|VeinViewer|Veinveiwer is used to view veins subQ
12016598|NCT00468065|Device|Veinviewer|near infrared light reveals veins subcutaneously
12016599|NCT00468052|Drug|dexmedetomidine|2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion
12016600|NCT00468052|Drug|fentanyl|1 microgram/kilogram as a bolus
12016601|NCT00468039|Drug|vildagliptin + metformin|
12016602|NCT00468026|Device|ProstaPlant Stent|
12016603|NCT00468013|Behavioral|Resilience Building Exercises|Weekly exercises for 6 weeks
12016604|NCT00468013|Behavioral|Journaling|Weekly exercises for 6 weeks
12016605|NCT00468000|Biological|Ixmyelocel-T|IM injection
12016606|NCT00468000|Biological|Placebo|IM Injection
12016607|NCT00467987|Drug|androgel|androgel 1%
12016608|NCT00467987|Drug|placebo|placebo
12016609|NCT00467974|Procedure|TEA with LEM|Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)
12016610|NCT00467974|Procedure|TACE|Transarterial chemoembolisation (TACE)
12016611|NCT00467961|Combination Product|Miltenyi system|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach.
12016612|NCT00467948|Drug|cefazolin|
12016613|NCT00467935|Drug|intravitreal injection Lucentis (ranibizumab)|intravitreal injection Lucentis (ranibizumab)
12016614|NCT00467922|Drug|Hextend|Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
12016615|NCT00467922|Drug|Lactated Ringers|Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
12016616|NCT00467909|Behavioral|micronutrients|
12016617|NCT00467896|Drug|Iloprost PD-6|Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.
12016618|NCT00467896|Drug|Iloprost PD-15|Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.
12016619|NCT00467883|Drug|Liposomal Amphotericin B|high dosage
12016620|NCT00467870|Drug|Testosterone Undecanoate 750 mg|
12016621|NCT00467870|Drug|Testosterone Undecanoate 1000 mg|
12016622|NCT00467857|Procedure|InteguSeal* skin sealant and standard surgical preparation|Surgical skin preparation prior to incision using InteguSeal* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
12016623|NCT00467857|Other|Standard preoperative skin preparation|Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
12016624|NCT00467844|Drug|GTx-024|1 mg GTx 024
12016625|NCT00467844|Drug|GTx-024|3 mg GTx-024
12016626|NCT00467844|Drug|Placebo|Matching Placebo
12016627|NCT00467831|Drug|Losartan|Losartan potassium tablet, 25 mg by mouth every night at bedtime.
12016628|NCT00467831|Drug|Zileuton|Zileuton tablet, 1200 mg by mouth twice daily.
12016629|NCT00467831|Drug|N-Acetylcysteine|N-acetylcysteine solution, 600 mg by mouth three times daily.
12016630|NCT00467831|Drug|Pravastatin|Pravastatin sodium tablet, 20 mg by mouth every night at bedtime.
12016631|NCT00467831|Drug|Erythromycin|Erythromycin tablet, 333 mg by mouth three times daily.
12016632|NCT00467818|Drug|Omega 3 fatty acids|The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.
12016633|NCT00467818|Other|Placebo|Same dosage as that of omega 3 fatty acids
12016634|NCT00467805|Procedure|Light therapy|
12016635|NCT00467779|Drug|cobimetinib|Repeating oral dose
12016636|NCT00467779|Drug|dextromethorphan|In Stage III only: single dose of dextromethorphan
12016637|NCT00467779|Drug|midazolam|In Stage III only: single dose of midazolam
12016638|NCT00467766|Behavioral|Psychosocial information, counseling, and support|
12016639|NCT00467766|Drug|Donepezil (Aricept)|
12016640|NCT00467753|Drug|Oxcarbazepine|Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the morning for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a Clinical Global Improvement Scale (CGI) of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose.
12016641|NCT00467753|Other|Placebo/sugar pill|Dosage similar to active drug
12016642|NCT00467740|Drug|BI 1744 CL|
12016643|NCT00467727|Other|Phase Contrast Mammography|Standard and magnification views
12016644|NCT00467714|Procedure|rhinoplasty|COLUMELLA STRUT PLACEMENT
12016645|NCT00467688|Device|Real time access to current glucose values during CGMS|One arm gets real time access to current measured glucose values and hypoglycemic or hyperglycemic alerts are elicited, The second arm get´s a retrospective analysis of glucose values
12016646|NCT00467675|Device|CGM System for Type 1 and Type 2 Diabetes Mellitus|
12016647|NCT00467662|Drug|Acyclovir 5%|
12016648|NCT00467662|Drug|Docosanol 10%|
12016649|NCT00467662|Device|Superlysine gel|
12016650|NCT00467649|Drug|pramlintide acetate (Symlin)|subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
12016651|NCT00467649|Drug|rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])|subcutaneous injection, dosing based on titration guidelines
12016652|NCT00467649|Drug|basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])|subcutaneous injection, dosing based on titration guidelines
12016653|NCT00467636|Procedure|Blood glucose monitoring|Regular pre and post meal blood glucose monitoring.
12016654|NCT00467636|Drug|Insulin Glulisine|Sub cutaneous injection given twice daily for 3 days. Dosage titrated to body mass index and body weight (BMI < 30 = 0.1 unit/kg. BMI > 30 = 0.2 unit/kg)
12016655|NCT00467610|Drug|Panhematin|
12016656|NCT00467597|Drug|Levodopa (delivered intravenously)|"IV Levodopa is given from 09:00 to 11:00 am during the testing phase of the study. The IV Levodopa allows the researchers to watch one full on and off levodopa cycle while in the inpatient unit."
12016772|NCT00466752|Other|immunohistochemistry staining method|Correlative studies
12016657|NCT00467584|Drug|High Dose Aspirin (1300 mg/day)|1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
12016658|NCT00467584|Drug|Low Dose Aspirin (162 mg/day)|162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
12016659|NCT00467584|Drug|Placebo|Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks
12016660|NCT00467571|Drug|lansoprazole, clarithromycin, amoxycillin|lansoprazole (15, 30 mg) 1 tab twice daily, clarithromycin 7.5 mg/kg twice daily, amoxycillin 25 mg/kg twice daily; rout: orally; duration 14 days
12016661|NCT00467558|Drug|Naltrexone|daily
12016662|NCT00467558|Drug|Sugar pill|daily
12016663|NCT00467545|Drug|telbivudine|
12016664|NCT00467519|Biological|Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)|0.5 mL, IM
12016665|NCT00467519|Biological|DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)|0.5 mL, IM
12016666|NCT00467506|Drug|bispecific antibody and di-DTPA-131I|
12016667|NCT00467493|Drug|Anastrozole|
12016668|NCT00467467|Drug|Alfuzosin Hydrochloride|
12016669|NCT00467454|Drug|Naltrexone|daily
12016670|NCT00467454|Drug|Placebo|daily
12016671|NCT00467441|Drug|VSF-173|
12016672|NCT00467428|Drug|NS2359|
12016673|NCT00467428|Drug|Placebo|
12016674|NCT00467415|Behavioral|Partial body weight support treadmill training|Treadmill ambulation for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
12016675|NCT00467415|Behavioral|Exercise|Functional Strengthening exercise program for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
12016676|NCT00467402|Drug|agomelatine|
12016677|NCT00467402|Drug|placebo|
12016678|NCT00467389|Drug|Donepezil, 5 mg daily|This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
12016679|NCT00467389|Other|Oral Placebo|Inactive Comparator with Similar Appearance to Active Medication
12016680|NCT00467376|Drug|Insulin Glulisine|3 times a day before each meal
12016681|NCT00467376|Drug|Lispro|3 times a day before each meal
12016682|NCT00467376|Drug|Insulin Glargine|once daily
12016683|NCT00467363|Drug|acetylsalicylic-acid (aspirin)|81mg of low-dose aspirin plus 400micrograms of folic acid.
12016684|NCT00467363|Dietary Supplement|Folic acid|400micrograms of folic acid.
12016685|NCT00467350|Drug|PEG 3350|PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
12016686|NCT00467350|Drug|milk and molasses enema|enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
12016687|NCT00467337|Procedure|Medial-Wedge Insole intervention|
12016688|NCT00467324|Device|Aspire Medical Advance System|The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.
12016689|NCT00467298|Behavioral|Exercise adherence|The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.
12016690|NCT00467298|Behavioral|Self-management- prevention of illness|Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.
12016691|NCT00467298|Behavioral|Self-management of illness|This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.
12016692|NCT00467272|Drug|Daptomycin|6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria.
12016693|NCT00467259|Drug|Testosterone Transdermal System|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
12016694|NCT00467259|Drug|Placebo patch|placebo patch, changed twice a week for 52 weeks
12016695|NCT00467246|Drug|Levemir|
12016696|NCT00467233|Procedure|Laser Treatment|Laser treatment to half of the face at each study visit
12016697|NCT00467233|Procedure|Acid Peel|Acid peel to half of the face at each study visit
12016698|NCT00467220|Behavioral|calorie restriction|"Subjects in the calorie restriction arm and the alternate day fasting arm will be asked to follow a menu plan, for three months, that includes some level of calorie restriction."
12016699|NCT00467207|Drug|Botulinum Toxin A|
12016700|NCT00467207|Behavioral|Resistance training|
12016701|NCT00467194|Drug|Rapamycin|
12016702|NCT00467194|Drug|Bevacizumab|
12016703|NCT00467181|Drug|Fenoldopam|
12016704|NCT00467168|Behavioral|Diet|
12016705|NCT00467142|Biological|bevacizumab|
12016706|NCT00467142|Drug|fluorouracil|
12016707|NCT00467142|Drug|irinotecan hydrochloride|
12016708|NCT00467142|Drug|leucovorin calcium|
12016709|NCT00467142|Genetic|polymorphism analysis|
12016710|NCT00467129|Genetic|microarray analysis|
12016711|NCT00467129|Genetic|mutation analysis|
12016712|NCT00467129|Genetic|polymerase chain reaction|
12016713|NCT00467129|Genetic|polymorphism analysis|
12016714|NCT00467129|Other|laboratory biomarker analysis|
12016715|NCT00467129|Other|questionnaire administration|
12016716|NCT00467116|Biological|cetuximab|400mg/m2 initial dose week 1; followed by 250mg/m2/weekly starting week 2 with gemcitabine at fixed dose rate (10 mg/m2/min) + XRT. Cetuximab will start 1 week prior to all other treatment.
12016717|NCT00467116|Drug|gemcitabine hydrochloride|"Dose Level Gemcitabine dose Gemcitabine infusion
~-1 150mg/m2 15 Minutes 0 200mg/m2 20 minutes
~300mg/m2 30 minutes
~400mg/m2 40 minutes"
12016718|NCT00467116|Radiation|radiation therapy|"50.4 Gy, 28 fractions, 5.5 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to encompass gross disease with a margin of 1-1.5 cm.
~The prescription point will be designated at the intersection of the multiple beams.
~There are no planned interruptions > 3 days."
12016773|NCT00466752|Genetic|gene expression analysis|Correlative studies
12016719|NCT00467077|Biological|PEG-interferon alfa-2b|PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks
12016720|NCT00467077|Drug|gefitinib|ZD1839 will be administered at a dose of 250 mg orally once daily,
12016721|NCT00467064|Behavioral|Arthritis Quick Start|Two week, lay led, workshop focusing on goal setting, problem solving, and content specific to disease management.
12016722|NCT00467064|Other|Delayed treatment intervention|After four months delay, participants in Control Group receive Experimental workshop.
12016723|NCT00467051|Drug|Carboplatin|Given IV
12016724|NCT00467051|Biological|Filgrastim|Given IV or subcutaneously
12016725|NCT00467051|Drug|Ifosfamide|Given IV
12016726|NCT00467051|Other|Laboratory Biomarker Analysis|Optional correlative studies
12016727|NCT00467051|Drug|Paclitaxel|Given IV
12016728|NCT00467038|Behavioral|Dialectical Behavior|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
12016729|NCT00467025|Drug|AMG 386|3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
12016730|NCT00467025|Drug|Sorafenib|400 mg PO BID
12016731|NCT00467025|Drug|AMG 386 placebo IV|AMG 386 placebo IV
12016732|NCT00467012|Drug|bevacizumab|10mg/kg，Day1, 15 of 1 cycle(4 weeks)
12016733|NCT00467012|Drug|Paclitaxel|90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)
12016734|NCT00466999|Drug|misoprostol|single dose of 400 mcg misoprostol administered sublingually
12016735|NCT00466999|Procedure|surgery|standard surgical treatment (dilation and curettage or manual vacuum aspiration)
12016736|NCT00466986|Drug|Abraxane|Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days
12016737|NCT00466973|Device|Dry bipolar radiofrequency (RF) clamp|Specified device used for ablation during standard surgical procedure
12016738|NCT00466973|Device|Unipolar microwave antenna|Specified device used for ablation during standard surgical procedure
12016739|NCT00466973|Device|Unipolar cryothermic probe|Specified device used for ablation during standard surgical procedure
12016740|NCT00466973|Device|Irrigated unipolar RF antenna|Specified device used for ablation during standard surgical procedure
12016741|NCT00466973|Device|Irrigated bipolar RF clamp|Specified device used for ablation during standard surgical procedure
12016742|NCT00466973|Device|Hi-intensity focused ultrasound wand|Specified device used for ablation during standard surgical procedure
12016743|NCT00466960|Biological|sargramostim|Given SC
12016744|NCT00466960|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
12016745|NCT00466960|Other|laboratory biomarker analysis|Correlative studies
12016746|NCT00466960|Other|immunologic technique|Correlative studies
12016747|NCT00466947|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 4 doses
12016748|NCT00466947|Biological|Havrix|Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group
12016749|NCT00466947|Biological|Engerix-B|Intramuscular injection, 3 doses
12016750|NCT00466947|Biological|Infanrix hexa|Intramuscular injection,3 doses
12016751|NCT00466947|Biological|GSK Biologicals' DTPa-IPV/Hib vaccine|Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group
12016752|NCT00466921|Drug|lenalidomide|10 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, increasing dose by 5 mg every cycle, up to a maximum of 25 mg.
12016753|NCT00466908|Device|Pentacam and IOL Master|Pentacam and IOL Master
12016754|NCT00466895|Drug|lenalidomide|Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21. Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21. Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21. Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21. Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21
12016755|NCT00466882|Device|Inamed Lap-Band System|Patient's will be seen in the physician's office one week post surgery and once a month thereafter. The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND. This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two years.
12016756|NCT00466869|Drug|Betahistine|
12016757|NCT00466856|Drug|octreotide acetate|"Lung/liver Ratio Dose of SIR-Spheres
~<10% Administer full dose of SIR-Spheres
~10% to 15% Reduce dose of SIR-Spheres by 20%
~16% to 20% Reduce dose of SIR-Spheres by 40%
~>20% Do not give SIR-Spheres"
12016758|NCT00466856|Radiation|yttrium Y 90 resin microspheres|radiation
12016759|NCT00466843|Drug|Antithymocyte globulin (ATG)|ATG 2.5 mg/kg/day via IV will be given for 4 doses. Each participant will receive only one cycle of therapy. The daily infusion will be administered over at least 6 hours and slowed as necessary to minimize infusion-related symptoms.
12016760|NCT00466843|Drug|Prednisone|All participants will be pre-treated with prednisone (1 mg/kg/day by mouth) 2 days prior to the first ATG does and continuing for 14 days after the final dose to prevent serum sickness
12016761|NCT00466830|Other|questionnaire administration|
12016762|NCT00466830|Procedure|management of therapy complications|
12016763|NCT00466830|Procedure|psychosocial assessment and care|
12016764|NCT00466830|Procedure|quality-of-life assessment|
12016765|NCT00466817|Other|Placebo|9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.
12016766|NCT00466817|Drug|Valganciclovir|Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
12016767|NCT00466804|Procedure|Heart transplant|People in this study will have a heart transplant and be monitored for signs of rejection
12016768|NCT00466791|Drug|Methylphenidate Transdermal System|Placebo
12016769|NCT00466765|Device|Brava Autologous Fat Transfer System|Number of procedures is based on patient need
12016770|NCT00466752|Drug|sorafenib tosylate|Given PO
12016771|NCT00466752|Genetic|microarray analysis|Correlative studies
12016985|NCT00464776|Drug|Aliskiren|
12016775|NCT00466752|Procedure|therapeutic conventional surgery|Undergo prostatectomy
12016776|NCT00466752|Other|laboratory biomarker analysis|Correlative studies
12016777|NCT00466752|Genetic|western blotting|Correlative studies
12016778|NCT00466752|Genetic|RNA analysis|Correlative studies
12016779|NCT00466726|Biological|bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine|
12016780|NCT00466726|Biological|sargramostim|
12016781|NCT00466713|Drug|Rosiglitazone therapy|
12016782|NCT00466687|Biological|bevacizumab|10mg/kg, slow IV infusion, Days 1 and 14
12016783|NCT00466687|Drug|erlotinib hydrochloride|150mg PO qd
12016784|NCT00466687|Genetic|fluorescence in situ hybridization|Targeting multiple genetic aberrations in isolated tumor cells.
12016785|NCT00466687|Genetic|gene expression analysis|gene expression analysis
12016786|NCT00466687|Other|immunologic technique|immunologic technique
12016787|NCT00466687|Other|laboratory biomarker analysis|laboratory biomarker analysis
12016788|NCT00466687|Procedure|biopsy|biopsy
12016789|NCT00466674|Drug|reduced intensity conditioning|reduced intensity conditioning for allogenic transplant
12016790|NCT00466661|Drug|Acamprosate|666 mg po TID
12016791|NCT00466661|Drug|Placebo|2 tabs po TID
12016792|NCT00466648|Procedure|Tissue adhesive|
12016793|NCT00466635|Drug|GT267-004 (tolevamer potassium sodium)|
12016794|NCT00466622|Drug|Metformin|1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.
12016795|NCT00466622|Drug|Placebo|Placebo 2 tablets x 2 daily. Orally from Weifa
12016796|NCT00466609|Drug|Clomipramine (fluoxetine plus clomipramine)|Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
12016797|NCT00466609|Drug|Quetiapine (fluoxetine plus quetiapine)|Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
12016798|NCT00466609|Drug|Placebo (fluoxetine plus placebo)|Placebo plus fluoxetine at maximum dosage of 80mg per day
12016799|NCT00466596|Drug|Gamma Tocopherol|14 days of daily high dose (1200mg) Gamma Tocopherol. Subjects will receive a 14 day supply (28 softgel capsules, approximately 600 grams of gT each) dispensed by the University of North Carolina Hospitals Investigational Drug Service and provided by YASOO Medical.
12016800|NCT00466583|Drug|Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)|IV infusion of EZN 2968 given in 6 week cycles for (3 weeks on 3 weeks off) until recommended phase 2 dose identified. Up to 3 intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.
12016801|NCT00466570|Drug|gatifloxacin, moxifloxacin|
12016802|NCT00466544|Device|Plasmaknife|
12016803|NCT00466544|Device|Monopolar|
12016804|NCT00466531|Biological|therapeutic autologous lymphocytes|
12016805|NCT00466531|Drug|cyclophosphamide|
12016806|NCT00466518|Drug|Administration of sitagliptin|Sitagliptin 100 mg daily for 3 months
12016807|NCT00466505|Biological|cetuximab|400 mg/m2 iv week 1, then 250 mg/m2 weekly thereafter, starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.
12016808|NCT00466505|Drug|celecoxib|200 mg po BID starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.
12016809|NCT00466505|Genetic|proteomic profiling|Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction. We will use LC-MS-MS or MALDITOF mass spectrometry.
12016810|NCT00466505|Other|immunohistochemistry staining method|phospho-EGFR levels using western blots of tissue extracts and immunohistochemistry on frozen and (if no other option available, paraffinembedded tissue sections).
12016811|NCT00466505|Other|laboratory biomarker analysis|Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction.
12016812|NCT00466505|Other|mass spectrometry|We will use LC-MS-MS or MALDITOF mass spectrometry. Before any tissues are received, the drug of interest is evaluated via MALDI mass spectrometry on a MDS/Sciex QStar QqTOF mass spectrometer.
12016813|NCT00466492|Procedure|Sedation or no sedation during mechanical ventilation|No sedation to critically ill patients
12016814|NCT00466479|Drug|brimonidine|
12016815|NCT00466479|Procedure|laser trabeculoplasty|
12016816|NCT00466466|Drug|Everolimus|RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.
12016817|NCT00466453|Behavioral|knowledge-adaptive Web-based instruction|
12016818|NCT00466440|Drug|enzastaurin|1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years
12016819|NCT00466440|Drug|placebo|Loading dose, then po QD until unblinding
12016820|NCT00466440|Drug|docetaxel|75 mg/m^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles
12016821|NCT00466440|Drug|prednisone|5 mg po BID, six 21-day cycles
12016822|NCT00466414|Device|Polycaprolactone Scaffold|
12016823|NCT00466401|Drug|Simvastatin|
12016824|NCT00466401|Drug|Ezetimibe|
12016825|NCT00466375|Genetic|Cheek cell samples or blood sample (4mL)|DNA will be extracted from cheek cell or blood samples from parents and child having hemangioma.
12016826|NCT00466375|Genetic|Cheek cell sample or blood sample (4mL)|DNA will be extracted from cheek cell or blood samples of parents and child with a vascular anomaly.
12016827|NCT00466362|Behavioral|The Evje Model|
12016828|NCT00466323|Behavioral|Family Member Provider Outreach|Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
12016829|NCT00466323|Behavioral|Enhanced treatment as usual (e-TAU)|Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
12016830|NCT00466310|Drug|Aripiprazole|Aripiprazole for 4 weeks
12016831|NCT00466310|Drug|Risperidone|Subjects will be randomized to risperidone for 4 weeks
12016832|NCT00466310|Other|Healthy volunteers|Healthy volunteers
12016833|NCT00466297|Behavioral|Face-to-face communication interactions|
12016834|NCT00466284|Drug|Tarceva (erlotinib)|
12016835|NCT00466258|Drug|R-CHOP|"Cyclophosphamide 750 mg/m2 i.v. day 1
~Adriamycin 50 mg/m2 i.v. day 1
~Vincristine 1,4 mg/m2 i.v. day 1
~Prednisone 100 mg i.v or oral. days 1-5."
12016836|NCT00466258|Drug|Highly active antiretroviral therapy|Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.
12016837|NCT00466258|Drug|Central nervous system (CNS) prophylaxis|methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
12016838|NCT00466258|Drug|Prophylaxis of opportunistic infections and support treatment|Pegfilgrastim
12016839|NCT00466245|Drug|MVA Smallpox vaccine|Two 0.5mL subcutaneous injections, separated by 28 days
12016840|NCT00466245|Drug|Placebo|Two 0.5mL subcutaneous injections, separated by 28 days
12016841|NCT00466232|Drug|Topotecan|4 mg/m2 IV on day 1, 8, 15. Repeat every 28 days.
12016842|NCT00466232|Drug|Sorafenib|Dose escalation study at 3 dose levels: 200 mg po daily, 200 mg po bid, 400 mg po bid.
12016843|NCT00466219|Drug|Ribavirin|
12016844|NCT00466219|Drug|Pegylated interferon alpha2a|
12016845|NCT00466206|Device|Magnetic Mini-Mover Procedure (3MP)|"A rare earth magnet encased in FDA-approved titanium will be implanted securely on the outer surface of the lower end of the sternum in patients with pectus excavatum. This is accomplished as an outpatient procedure, under brief general anesthesia.
~A 2-inch transverse skinline incision is made at the junction of the sternum and xyphoid and the space in front and behind the sternum is dissected bluntly. The titanium can containing the magnet is securely fixed to the sternum by screwing it into a titanium fixation disk in front of the sternum. The procedure takes 1/2-hour, and the patient can go home the same day.
~In another outpatient procedure, the Magnimplant is explanted 18 months after implantation."
12016846|NCT00466206|Device|Magnatract (external magnet in a removable external brace)|"An external orthotic device Magnatract which includes an external magnet in a removable brace is fitted specifically to the patient's chest wall deformity. A calibrated meter in the external device measures the force applied between the two magnets. When the patient and family are comfortable with the device and comfort and skin condition have been assessed, the patient will be allowed to take the Magnatract home and begin the process of gradually advancing the sternum forward as the abnormal costal cartilage is reformed."
12016847|NCT00466206|Procedure|3MP (Magnetic Mini-Mover Procedure)|"Subject has EKG performed to measure baseline cardiac activity.
~Magnimplant is implanted.
~After one week, Magnatract is fitted.
~Chest x-ray and 2nd EKG performed 30 days post-implantation.
~Patient and parents complete QoL questionnaire 30d post-implantation.
~Patient seen weekly for first month post-implantation to assess comfort and skin condition. Thereafter, will be seen monthly.
~At each monthly visit, patient will have lateral and anterior-posterior chest X-rays to monitor sternal correction.
~At each visit data logger is downloaded to measure strength of pull since last visit and amount of wear-time.
~Magnimplant explanted 18 months later as 1/2-hr outpatient procedure.
~CT scan and third EKG performed after explanation.
~Patient and parents complete QOL questionnaires after explantation and 1 yr post-explantation."
12016848|NCT00466193|Drug|zolpidem tartrate sublingual tablet|3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
12016849|NCT00466193|Drug|Placebo|Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
12016850|NCT00466180|Behavioral|Nevirapine from twice-a-day to once-a-day|
12016851|NCT00466167|Drug|Pramipexol Extended Release|
12016852|NCT00466167|Drug|Pramipexol Immediate Release|
12016853|NCT00466167|Drug|Placebo|
12016854|NCT00466154|Drug|Aspirin|
12016855|NCT00466141|Behavioral|Increased Exercise for weight loss maintenance|
12016856|NCT00466141|Behavioral|Daily Self-weighing for weight loss maintenance|
12016857|NCT00466141|Behavioral|Education for weight loss maintenance|
12016858|NCT00466128|Drug|indomethacin|Indomethacin 50mg PO followed by 25mg PO q6hrs
12016859|NCT00466102|Drug|RAD001|Tablet of 5 mg, 2 tablets (10 mg) are taken once daily during study therapy
12016860|NCT00466102|Drug|Placebo|2 tablets are taken once daily during study therapy
12016861|NCT00466089|Drug|Erlotinib (Tarceva®)|Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
12016862|NCT00466076|Drug|Copaxone (Glatiramer acetate)|
12016863|NCT00466063|Drug|Deferasirox|
12016864|NCT00466037|Biological|Influenza vaccine|
12016865|NCT00466024|Behavioral|Health Coach and HEPA Air cleaners|Health Coach for ETS reduction in home and 2 HEPA air cleaners
12016866|NCT00466024|Behavioral|Health Coach and HEPA air cleaners|Behavioral training and 2 HEPA air cleaners
12016867|NCT00465985|Drug|ACZ885|
12016868|NCT00465985|Drug|Placebo|
12016869|NCT00465972|Drug|Doxepin|Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length
12016870|NCT00465972|Drug|Temazepam|Temazepam capsule 15 mg po nightly x duration of study
12016871|NCT00465972|Drug|Placebo|Placebo capsule nightly for duration of study
12016872|NCT00465959|Drug|trospium chloride inhalation powder (TrIP)|
12016873|NCT00465959|Drug|Placebo|
12016874|NCT00465946|Behavioral|Salt Supplementation|
12016875|NCT00465933|Drug|AIDA|
12016876|NCT00465920|Behavioral|modified cognitive behavioural therapy (mCBT)|
12016877|NCT00465907|Drug|Paclitaxel, Carboplatin and Irinotecan|Paclitaxel-60mg/m2 weekly for 3 weeks Carboplatin - AUC 1.5, weekly for 3 weeks Irinotecan - 60mg/m2, weekly for 3 weeks
12016878|NCT00465894|Drug|Extended Release Tolterodine LA|Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks
12016879|NCT00465894|Drug|Intra Vaginal Estradiol Cream|17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.
12016986|NCT00464763|Drug|Dexmedetomidine|
12016880|NCT00465881|Device|CGM System for Type 1 and Type 2 Diabetes Mellitus|
12016881|NCT00465868|Procedure|PCI (percutaneous coronary intervention)|Outcome of PCI following AMI
12016882|NCT00465855|Combination Product|Hyperbaric Oxygen (HBO2) - 3 sessions|"Before patients are offered an opportunity to participate in this study, they will receive a single hyperbaric oxygen session. During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
~For the second and third hyperbaric oxygen sessions, the subject will breathe 100% oxygen delivered at 2 atm abs for 90 minutes with two 5-minute air breathing periods."
12016883|NCT00465855|Combination Product|Hyperbaric Oxygen (HBO2) - 1 session|"During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
~The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods."
12016884|NCT00465816|Biological|Nimenrix (Meningococcal vaccine 134612)|Single dose intramuscular injection
12016885|NCT00465816|Biological|Twinrix|3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
12016886|NCT00465803|Drug|Travoprost 0.004%/timolol 0.5% ophthalmic solution|One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid
12016887|NCT00465803|Drug|Travoprost ophthalmic solution, 0.004%|One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid
12016888|NCT00465803|Drug|Timolol maleate ophthalmic solution, 0.5%|One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid
12016889|NCT00465777|Behavioral|Guideline adherence and financial incentive|
12016890|NCT00465764|Other|Alternate protein infant formula|Feed as per HCP directions
12016891|NCT00465764|Other|Standard infant formula|Feed as per HCP directions
12016892|NCT00465751|Drug|chenodeoxycholic acid|chenodeoxycholic acid 500 mg capsules tid po
12016893|NCT00465751|Drug|placebo capsules|placebo capsules containing mannitol tid po
12016894|NCT00465738|Drug|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)"|active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride [NaCl] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
12016895|NCT00465725|Drug|Picoplatin|The IV dose will be 120 mg/m2. Three oral dose levels will be studied sequentially (6 subjects per dose level) in the absence of dose limiting toxicity 200 mg, 300 mg, or 400 mg total dose.
12016896|NCT00465712|Procedure|transabdominal amnioinfusion|transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version
12016897|NCT00465699|Drug|Topical B12 0.07%|
12016898|NCT00465686|Device|ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)|ergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions
12016899|NCT00465686|Device|ergonomic desk and chair (Q-Learn Desk)|child sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk
12016900|NCT00465673|Drug|Liposomal Doxorubicin|40mg/m2 over 1 hour infusion for 21 days
12016901|NCT00465660|Behavioral|Progressive resistance training|
12016902|NCT00465647|Drug|Hydromorphone|Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
12016903|NCT00465621|Drug|Xalatan|
12016904|NCT00465608|Drug|propranolol|propranolol by mouth (per os)
12016905|NCT00465595|Drug|psilocybin|The dose of psilocybin received in the two sessions will range anywhere from low to high.
12016906|NCT00465569|Drug|cow's milk powder|Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks
12016907|NCT00465569|Other|Placebo|
12016908|NCT00465556|Behavioral|Public Health Nurse Home Visit|The perinatal public health nurse home visit intervention also includes a trifold brochure, printed on 8X10 inch paper, with 6 panels, that can be read with the woman in an interactive manner so that the woman is encouraged to describe her experiences and choose her options as they proceed. Participants will receive three prenatal and three postpartum sessions. The first prenatal sessions will be given during the first (enrollment), second, and third trimesters, with at least three weeks between sessions. Women entering the study after the first trimester will receive the initial session at enrollment, with two subsequent sessions spread out over the remainder of the scheduled prenatal home visitation program sessions.
12016909|NCT00465556|Behavioral|Intimate Partner Violence (IPV) Protocol|The current protocol in use by the participating health departments when a women screens positive for intimate partner violence (IPV), current or history within the last year.
12016910|NCT00465543|Other|Mint tea high in rosmarinic acid|Mint tea high in rosmarininc acid contains 150mg of rosmarinic acid. To be consumed twice a day for 4 weeks. Brewed in 150ml of boiling water and allowed to steep for 10 minutes.
12016911|NCT00465543|Other|Mint tea low in rosmarinic acid|Mint tea low in rosmarininc acid contains 10mg of rosmarinic acid. To be consumed twice a day for 4 weeks. Brewed in 150ml of boiling water and allowed to steep for 10 minutes.
12016912|NCT00465530|Drug|Saline|Intranasal Saline
12016913|NCT00465530|Drug|Gentamycin|Intranasal irrigation
12016914|NCT00465517|Drug|Ganaxolone|Oral suspension 200-500 mg 3x/day
12016915|NCT00465517|Other|Placebo|non-active placebo
12016916|NCT00465504|Procedure|iontophoresis|See Detailed Description.
12016917|NCT00465491|Drug|picoplatin|IV picoplatin 150mg/m2 q3wk
12016918|NCT00465491|Other|best supportive care|best supportive care
12016919|NCT00465478|Procedure|Autologous bone marrow mononuclear cell transplantation|
12016920|NCT00465465|Biological|MVA 85A|i.d. injection
12016987|NCT00464763|Drug|Placebo|
12016921|NCT00465452|Drug|Continuous Release Dopamine Agonists|Continuous Release Dopamine Agonists
12016922|NCT00465439|Drug|Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine|10 ml subcutaneously
12016923|NCT00465413|Device|Small volume spacer and/or Rinsing the mouth with water|
12016924|NCT00465387|Behavioral|Falls, Fractures & Osteoporosis Risk Assessment & Management|
12016925|NCT00465374|Procedure|Change ventilatory parameters with stress index monitoring|
12016926|NCT00465361|Procedure|performance feedback with an educational module|individual performance feedback with an educational module
12016927|NCT00465322|Drug|fluvastatin|
12016928|NCT00465309|Procedure|protective ventilation with CO2 removal technique|In ARDS patients, presenting a Pplat ≥ 26 cmH2O, Vt was lowered (reaching a Pplat < 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH > 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.
12016929|NCT00465296|Drug|rosiglitazone|
12016930|NCT00466388|Drug|Cevimeline|
12016931|NCT00465283|Drug|Donepezil|Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
12016932|NCT00465270|Device|AMPLATZER PFO Occluder|patent foramen ovale closure device
12016933|NCT00465270|Other|Standard of Care - Medical Management|Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
12016934|NCT00465257|Drug|artesunate + amodiaquine|
12016935|NCT00465244|Drug|Levetiracetam 1 g IV + Lorazepam 2 mg IV|Levetiracetam 1 g IV + Lorazepam 2 mg IV
12016936|NCT00465244|Drug|Placebo + Lorazepam 3 mg IV|Placebo + Lorazepam 3 mg IV
12016937|NCT00465231|Drug|bupivacaine, fentanyl|10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml
12016938|NCT00465231|Drug|preservative free saline|10mL saline solution
12016939|NCT00465218|Procedure|Prophylaxis of Thrombosis after aortic valve replacement|Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
12016940|NCT00465205|Drug|Valacyclovir|500mg oral twice daily
12016941|NCT00465205|Drug|Matching Placebo|500 mg oral twice daily
12016942|NCT00465192|Drug|estradiol, 10 mcg|
12016943|NCT00465192|Drug|estradiol, 25 mcg|
12016944|NCT00465192|Drug|placebo|
12016945|NCT00465179|Drug|Sunitinib Malate|50 mg by mouth daily for 4 weeks, then 2 weeks off.
12016946|NCT00465166|Procedure|Ultrasound|Lumbar ultrasound from L1-S1, carried out using a portable ultrasound system equipped with a 2-5 MHz curved array probe.
12016947|NCT00465153|Dietary Supplement|flax oil containing alpha linolenic acid|14g alpha linolenic acid per day
12016948|NCT00465153|Behavioral|Resistance exercise training|Resistance training
12016949|NCT00465140|Drug|creatine supplementation|
12016950|NCT00465140|Behavioral|aerobic exercise training|
12016951|NCT00465114|Procedure|Hemodynamic Monitoring|
12016952|NCT00465101|Device|GreenLight HPS|Greenlight HPS laser system for treatment of BPH
12016953|NCT00465088|Drug|Niacin ER/Simvastatin Tablets|Up to 2000 mg/40 mg at bedtime
12016954|NCT00465088|Drug|atorvastatin|40 mg at bedtime
12016955|NCT00465075|Drug|Bazedoxifene/conjugated estrogens combination|
12016956|NCT00465049|Other|PRIMARY CLOSRE|SUTURE
12016957|NCT00465049|Other|SECONDARY CLOSURE|ALLOW TO HEAL SPONTANEOUSLY
12016958|NCT00465049|Other|SPONTANEOUS HALING|SECONDARY HEALING AFTER I&D
12016959|NCT00465036|Dietary Supplement|Whole flaxseeds, flaxseed mucilage, glucomannan|
12016960|NCT00465023|Procedure|Proton Beam Radiation|Once a day, 5 days a week (Monday-Friday) for 3 weeks.
12016961|NCT00465010|Behavioral|Talking Parents, Healthy Teens|Talking Parents, Healthy Teens is a worksite-based parenting program to help parents of 6th-10th graders learn to promote their adolescents' healthy sexual development. The program is administered in 8 weekly one-hour sessions during the lunch hour to groups of about 15 parents and focuses on parent-adolescent relationships and communication, with an emphasis on promoting sexual health and reducing sexual risk. It is led by a trained facilitator and assistant facilitator.
12016962|NCT00464984|Behavioral|Lifestyle intervention|Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study
12016963|NCT00464971|Drug|estradiol, 25 mcg|
12016964|NCT00464958|Drug|sublingual tizanidine 12 mg|Single sublingual tizanidine 12 mg tablet, to be administered once nightly, via sublingual administration for 12 months
12016965|NCT00464945|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose at 2,3,4 and 12 months of age
12016966|NCT00464932|Drug|Vasoactive Intestinal Peptide (VIP)|
12016967|NCT00464919|Drug|Sorafenib|
12016968|NCT00464919|Drug|tegafur/uracil (UFUR®)|
12016969|NCT00464893|Drug|Catumaxomab|10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
12016970|NCT00464893|Drug|catumaxomab|10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
12016971|NCT00464880|Drug|Aliskiren|
12016972|NCT00464867|Biological|Whole cell killed cholera vaccine & probiotic|The oral cholera vaccine Dukoral will be administered to all study participants in two doses,two weeks between doses.Each dose of the formalin inactivated whole cell vaccine contains one mg of recombinant B subunit of cholera toxin(rCTB).The vaccine will be administered in bicarbonate-tartaric acid buffer to counteract the effect of low pH in the stomach.
12016973|NCT00464854|Drug|Glargine and insulin aspart or lispro|
12016974|NCT00464841|Procedure|Combined spinal epidural|0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl
12016975|NCT00464841|Procedure|Tsui Test for intrathecal catheter|0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl
12016976|NCT00464828|Procedure|Internal jugular vein cannulation|
12016977|NCT00464828|Device|ultrasound|
12016978|NCT00464815|Biological|Meningococcal vaccine GSK134612|One intramuscular dose
12016979|NCT00464815|Biological|Mencevax™ ACWY|One subcutaneous dose
12016980|NCT00464802|Drug|MOA-728|
12016981|NCT00464789|Drug|Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet|
12016982|NCT00464776|Drug|Aliskiren|
12016983|NCT00464776|Drug|Aliskiren|
12016984|NCT00464776|Drug|Aliskiren|
12016988|NCT00464750|Device|Pulmonary artery catheter|Four series of cardiac output measurements, each series consists of eight measurements using cold and eight measurements using tepid injectate. Randomized order of temperature at first series and crossover design.
12016989|NCT00464737|Drug|Rotigotine|Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch)
12016990|NCT00464737|Drug|Rotigotine|Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches)
12016991|NCT00464737|Other|Placebo|Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.
12016992|NCT00464724|Procedure|3T Magnetic Resonance Spectroscopic Imaging|Part 1 of Study = One MRSI exam with an air-filled endorectal coil (AIR-MRSI) and one with a PFC-filled endorectal coil (PFC-MRSI); Part 2 of Study = MRSI exam with PFC using an endorectal coil only.
12016993|NCT00464711|Drug|Escitalopram|Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.
12016994|NCT00464698|Drug|Duloxetine|Participants received increasing amounts of Duloxetine for 7 weeks.
12016995|NCT00464685|Drug|Dexamethasone|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.
12016996|NCT00464685|Drug|Sham injection|Initial sham injection with up to 1 additional treatment based on re-treatment criteria.
12016997|NCT00464685|Procedure|Laser Photocoagulation|Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
12016998|NCT00464672|Biological|Influenza virus vaccine|Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
12016999|NCT00464672|Biological|Comparator influenza vaccine|Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
12017000|NCT00464659|Device|Effective CPAP|Auto-titrating CPAP machines (Remstar Auto; Philips Respironics, Murrysville, PA) provided by a home care company (Bastide Medical, France). Pressure was set between 6 and 14 cm of water
12017001|NCT00464659|Device|Sham CPAP|Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.
12017002|NCT00464646|Drug|Epirubicin|Both Cohorts: Epirubicin 90 mg/m2 IV every 21 days x 4 cycles
12017003|NCT00464646|Drug|Cyclophosphamide|Both Cohorts: Cyclophosphamide 600 mg/m2 IV every 21 days x 4 cycles
12017004|NCT00464646|Drug|Docetaxel|Both Cohorts: Docetaxel 100 mg/m2 IV on Day 1 every 21 days x 4 cycles
12017005|NCT00464646|Drug|Trastuzumab|"Cohort A: Pre-op therapy - 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly (16+ weeks) until 1-7 days prior to surgery. Post-operative therapy (beginning no sooner than 28 days after surgery and continuing every 3 weeks x 13 doses) - 8 mg/kg IV first post-op dose, then subsequent doses at 6 mg/kg IV
~Cohort B: 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly on days 1, 8, and 15. Three (3) weeks after last dose of docetaxel, 6 mg/kg IV and continuing every 3 weeks x 13 doses"
12017006|NCT00464646|Drug|Bevacizumab|"Cohort A: Cycles 1-4, 15 mg/kg IV on day 1 of cycle 4 only; Cycles 5-7, 15 mg/kg IV on day 1 every 21 days x 3 cycles; post-operative therapy (beginning no sooner than 28 days after surgery), 15 mg/kg IV every 3 weeks x 13 doses
~Cohort B: Cycles 5-8, 15 mg/kg IV on day 1 every 21 days x 4 cycles; beginning 3 weeks after last dose of docetaxel, 15 mg/kg IV every 3 weeks x 13 doses"
12017007|NCT00464633|Drug|alvocidib|"1st dose: 30 mg/m2 as a 30-minute intravenous (IV) infusion followed by 30 mg/m2 as a 4-hour continuous infusion
~Then, every treatment week, depending upon the patient's objective response to initial therapy:
~30 mg/m2 over 30 minutes followed by 50 mg/m2 over 4 hours or
~30 mg/m2 over 30 minutes followed by 30 mg/m2 over 4 hours."
12017008|NCT00464620|Drug|Dasatinib|oral agent, continuous dosing, Cycles = 28 days
12017009|NCT00464607|Drug|hMG-IBSA|
12017010|NCT00464607|Procedure|Ovarian stimulation|
12017011|NCT00464594|Behavioral|Standard lifestyle guidance|
12017012|NCT00464594|Drug|Lifestyle guidance and monotherapy with acarbose|
12017013|NCT00464594|Drug|Lifestyle guidance and monotherapy with metformin|
12017014|NCT00464594|Drug|Lifestyle guidance and monotherapy with gliclazide|
12017015|NCT00464568|Drug|GSK256066|
12017016|NCT00464555|Procedure|Islet transplant|Transplantation of pancreatic islet cells
12017017|NCT00464555|Drug|Antithymocyte globulin|Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
12017018|NCT00464555|Drug|Basiliximab|Will replace antithymocyte globulin in all islet transplantations after the first one
12017019|NCT00464555|Drug|Lisofylline|An anti-inflammatory that may reduce the rate at which islet cells die.
12017020|NCT00464555|Drug|Sirolimus|Maintenance immunosuppressive therapy
12017021|NCT00464555|Drug|Tacrolimus|Maintenance immunosuppressive therapy
12017022|NCT00464542|Drug|Metronidazole|500 mg, taken by mouth, two times a day, 7 days
12017023|NCT00464529|Device|Real-Time Continuous Glucose monitoring System (RT-CGMS)|
12017024|NCT00464516|Drug|placebo|once daily for 14 days orally
12017025|NCT00464516|Drug|Estetrol|once daily for 14 days orally
12017026|NCT00464503|Drug|Rosuvastatin-Crestor|
12017027|NCT00464503|Drug|Pravastatin-Pravasine|
12017028|NCT00464490|Drug|Dexmedetomidine|Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine will be titrated according to blood pressure, RASS and heart rate response and the dose will be lowered only after sedation is discontinued or markedly reduced.
12017029|NCT00464464|Behavioral|cognitive-behavioral therapy|The therapy will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD.
12017030|NCT00464451|Drug|Dexmedetomidine|Dexmedetomidine 3 micrograms per kilogram per os; subsequent dose of 1 microgram per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.
12017031|NCT00464451|Drug|Chloral hydrate|Chloral hydrate 75 milligrams per kilogram per os; subsequent dose of 25 milligrams per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.
12017032|NCT00464438|Drug|gatifloxacin|Day 1-6 = 1 drop of study medication three times a day
12017033|NCT00464438|Drug|moxifloxacin 0.5% eye drops|Day 1-6 = 1 drop of study medication three times a day
12017034|NCT00464425|Procedure|Electroacupuncture|EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles
12017035|NCT00464425|Procedure|Sham Acupuncture|Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used
12017036|NCT00464425|Other|No Acupuncture|Control
12017037|NCT00464412|Behavioral|Education|
12017038|NCT00464399|Drug|everolimus|
12017039|NCT00464386|Device|Continuous Glucose Monitoring|measure glucose levels on burn patients
12017040|NCT00464373|Drug|Botulinum Toxin Type A|Single intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)
12017041|NCT00464373|Drug|Placebo|4ml NaCl 0.9%
12017042|NCT00464347|Drug|Avastin|
12017043|NCT00464347|Procedure|Photodynamic Therapy (PDT)|
12017044|NCT00464347|Drug|Preservative-Free Triamcinolone Acetonide (TAC-PF)|
12017045|NCT00464334|Biological|V950|V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.
12017046|NCT00464334|Biological|ISCOMATRIX™|ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
12017047|NCT00464334|Biological|Placebo to V950|
12017048|NCT00464321|Biological|GC1008|1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
12017049|NCT00464321|Biological|GC1008|2 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
12017050|NCT00464321|Biological|GC1008|4 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
12017051|NCT00464321|Biological|GC1008|0.3 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
12017052|NCT00464308|Drug|Esomeprazole|20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
12017053|NCT00464308|Drug|Rabeprazole|20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
12017054|NCT00464308|Drug|Esomeprazole|40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
12017055|NCT00464295|Drug|Capecitabine in HCC|
12017056|NCT00464269|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Film-coated tablet
~Concentration: 2.5 mg, 10 mg and 25 mg
~Route of Administration: Oral use"
12017057|NCT00464269|Drug|Brivaracetam 2.5 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 2.5 mg
~Route of Administration: Oral use"
12017058|NCT00464269|Drug|Brivaracetam 10 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 10 mg
~Route of Administration: Oral use"
12017059|NCT00464269|Drug|Brivaracetam 25 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 25 mg
~Route of Administration: Oral use"
12017060|NCT00464256|Drug|rimonabant|
12017061|NCT00464243|Drug|volinanserin|oral administration
12017062|NCT00464243|Drug|placebo|oral administration
12017063|NCT00464230|Procedure|Bipolar hemiarthroplasty (Charnley/Hastings)|
12017064|NCT00464230|Procedure|Internal fixation with two parallel screws (Olmed)|
12017065|NCT00464217|Drug|ARA-C|
12017066|NCT00464217|Drug|Idarubicin|
12017067|NCT00464217|Drug|Leucomax|
12017068|NCT00464204|Drug|"6 % Hydroxyethylstarch 130/0.4 = Voluven®"|Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.
12017069|NCT00464204|Drug|0.9 % NaCl|NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.
12017070|NCT00464191|Drug|escitalopram|
12017071|NCT00464178|Drug|Bortezomilb|Bortezomilb will be administered at 1.3 mglm2 IVP on Days 1. 4, 8, and 11. Response will be assessed subsequent to each cycle. A total of 8 cycles would beplanned. Patients would be removed subsequent to Cycle 2. if progression of disease is documented.
12017072|NCT00464165|Drug|rimonabant|
12017073|NCT00464139|Procedure|Laparoscopy|Laparoscopy
12017074|NCT00464126|Other|5% albumin|5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
12017075|NCT00464126|Other|crystalloid|saline in 10cc/kg aliquots for postoperative volume resuscitation
12017076|NCT00464113|Drug|XL228|1-hour IV infusion
12017077|NCT00464087|Drug|Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin|
12017078|NCT00464061|Drug|Volinanserin|oral administration
12017079|NCT00464061|Drug|Placebo|oral administration
12017080|NCT00464048|Procedure|controlled physical exercise|
12017081|NCT00464035|Behavioral|high calcium intake|
12017082|NCT00464022|Device|Carbon dioxide|
12017083|NCT00464009|Behavioral|Continuing medical education|"Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using learning collaborative methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist."
12017084|NCT00463983|Drug|octreotide|
12017085|NCT00463970|Behavioral|Brief Intervention|Physical examination, education and follow up by a physiotherapist
12017086|NCT00463970|Behavioral|Cognitive Behavioural Therapy|7 sessions of CBT over a period of 2 months, included a booster session after 3 months
12017087|NCT00463970|Dietary Supplement|Seal oil|20 capsules per day for 3 months
12017088|NCT00463970|Dietary Supplement|Soy oil|20 capsules per day for 3 months
12017089|NCT00463957|Drug|sildenafil|
12017090|NCT00463957|Drug|tadalafil|
12017091|NCT00463957|Drug|placebo|
12017092|NCT00463944|Behavioral|Effect of an electronic voting system|
12017093|NCT00463918|Drug|varenicline|
12017094|NCT00463905|Procedure|Clinical assessment +/- radiography|Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance
12017095|NCT00463892|Procedure|High-resolution contrast-enhanced MRI scan|High-resolution contrast-enhanced MRI scan of regional lymph nodes every 6 months on study
12017096|NCT00463879|Drug|Galantamine|
12017097|NCT00463866|Drug|Budesonide/formoterol|
12017098|NCT00463853|Procedure|Autologous stem cell therapy|
12017099|NCT00463853|Procedure|CABG|
12017100|NCT00463853|Radiation|CMRI|
12017101|NCT00463840|Drug|Oxaliplatin|
12017102|NCT00463840|Drug|5FU|
12017103|NCT00463840|Radiation|Radiation|
12017104|NCT00463840|Procedure|Surgery|
12017105|NCT00463840|Drug|FOLFOX 6|this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin
12017106|NCT00463827|Drug|Atorvastatin|
12017107|NCT00463827|Drug|atorvastatin|atorvastatin 40mg
12017108|NCT00463827|Drug|matched placebo|Matched placebo
12017109|NCT00463814|Drug|AZD6244|oral capsule
12017110|NCT00463801|Drug|Daptomycin|
12017111|NCT00463788|Drug|cetuximab, cisplatin|"Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m^2) followed by weekly doses of 250 mg/m^2. All doses will be given by intravenous (IV) infusion.
~Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.
~Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression, unacceptable toxicity or withdrawal of consent."
12017112|NCT00463788|Drug|cisplatin|"Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.
~Subjects have the option of receiving cetuximab plus cisplatin at progression within the first 6 cycles, or cetuximab alone at progression after the 6 cycles.
~Administration of the IMP will be stopped upon the first occurrence of disease progression (except in cisplatin arm where switch to cetuximab plus cisplatin, or cetuximab alone is possible), unacceptable toxicity or withdrawal of consent."
12017113|NCT00463775|Drug|Topiramate|SSRI plus topiramate SSRI plus placebo
12017114|NCT00463762|Drug|CP-75385-02 Cefoperazone/sulbactam|
12017115|NCT00463749|Drug|Acetylcystein|high-dose N-Acetylcystein during PCI and for 2/day for 2 days
12017116|NCT00463749|Drug|Placebo|NaCl as placebo
12017117|NCT00463736|Drug|Magnesium sulfate|
12017118|NCT00463723|Drug|FK506 0.06% (eye drops)|
12017119|NCT00463710|Drug|Avonex® monotherapy (6.0 MIU administered i.m. each week)|
12017120|NCT00463697|Drug|GW642444H (100mcg)|H salt
12017121|NCT00463697|Drug|placebo|placebo
12017122|NCT00463697|Drug|GW642444M (25, 100 & 400 mcg)|M salt
12017123|NCT00463684|Biological|Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine|Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.
12017124|NCT00463684|Biological|Live, attenuated measles vaccine|Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.
12017125|NCT00463671|Drug|N-acetylcysteine|
12017126|NCT00463658|Other|Falls Prevention|Subjects in the interdisciplinary group will receive home care services from a team of professional service providers (CCAC Case Manager, Public Health Nurse (Registered Nurse), Occupational Therapist, Physiotherapist, Nutritionist) with experience and training in falls prevention. The team will provide a comprehensive, coordinated and evidence based approach to falls prevention through weekly case conferencing, a written interdisciplinary care plan, and joint client visits.
12017127|NCT00463645|Procedure|microdialysis|
12017128|NCT00463645|Procedure|microperfusion|
12017129|NCT00463619|Drug|Retarded release phosphatidylcholine|2g phosphatidylcholine, given QTD
12017130|NCT00463606|Drug|ABT-335 and rosuvastatin calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
12017131|NCT00463606|Drug|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
12017132|NCT00463606|Drug|rosuvastatin calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
12017133|NCT00463580|Drug|Infliximab|Participants will receive three infusions 5mg/kg of infliximab (at Baseline, Week 2 and Week 6)
12017134|NCT00463580|Drug|Placebo|Participants will receive three infusions of a placebo (at Baseline, Week 2 and Week 6)
12017135|NCT00463567|Drug|Indacaterol|In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
12017136|NCT00463567|Drug|Formoterol (12 µg b.i.d.)|Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
12017137|NCT00463567|Drug|Tiotropium (18 µg o.d.)|Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
12017138|NCT00463567|Drug|Placebo to Indacaterol|In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
12017139|NCT00463567|Drug|Placebo to Formoterol|In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
12017140|NCT00463554|Device|GYNECARE TVT-SECUR* System|A sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency
12017141|NCT00463541|Drug|solifenacin succinate|oral
12017142|NCT00463515|Drug|carboplatin/gemcitabine|
12017143|NCT00463515|Procedure|cisplatin/radiation therapy|
12017144|NCT00463502|Drug|Metformin|
12017145|NCT00463489|Behavioral|Lifestyle intervention|Women randomized to the lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.
12017146|NCT00463489|Behavioral|Mail-based|Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.
12017206|NCT00463021|Drug|Zemplar (paricalcitol injection)|
12017147|NCT00463476|Biological|Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV)|Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right upper arm using 23 gauge needles.
12017148|NCT00463463|Drug|90Yttrium Ibritumomab Tiuxetan (Zevalin)|
12017149|NCT00463450|Drug|Gynodian® Depot (BAY86-5032)|Injection monthly
12017150|NCT00463450|Drug|BAY86-4980|orally
12017151|NCT00463437|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 1 dose.
12017152|NCT00463437|Biological|Prevenar|Intramuscular injection, 1 dose.
12017153|NCT00463437|Biological|Infanrix hexa|Intramuscular injection, 1 dose. In Germany and Poland.
12017154|NCT00463437|Biological|Infanrix IPV Hib|Intramuscular injection, 1 dose. In Spain.
12017155|NCT00463437|Biological|Infanrix penta|Intramuscular injection, 1 dose. In Germany and Poland.
12017156|NCT00463437|Biological|Infanrix IPV|Intramuscular injection, 1 dose. In Spain.
12017157|NCT00463437|Biological|Meningitec|Intramuscular injection, 1 dose.
12017158|NCT00463437|Biological|NeisVac-C|Intramuscular injection, 1 dose.
12017159|NCT00463437|Biological|Menitorix|Intramuscular injection, 1 dose.
12017160|NCT00463424|Device|NeuFlex metacarpophalangeal implant|
12017161|NCT00463424|Device|Swanson metacarpophalangeal implant|
12017162|NCT00463385|Drug|Pomalidomide|
12017163|NCT00463385|Drug|Prednisone|Participants will take oral prednisone in the evening for 3 cycles of 28 days each (up to 84 days). The dose will be as follows: 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day.
12017164|NCT00463385|Drug|Placebo to pomalidomide|Matching pomalidomide placebo tablets
12017165|NCT00463385|Drug|Placebo to prednisone|Matching prednisone placebo tablets
12017166|NCT00463372|Drug|PF-02545920|
12017167|NCT00463359|Drug|Imiquimod cream|
12017168|NCT00463359|Procedure|curettage and cautery|
12017169|NCT00463346|Drug|Acamprosate|Acamprosate 1998 mg tid
12017170|NCT00463346|Drug|Placebo|Placebo
12017171|NCT00463320|Drug|Pazopanib eye drops and Allergen Refresh Plus eye drops|
12017172|NCT00463294|Procedure|Coronary Artery Bypass Graft with the use of CPB|Coronary Artery Bypass Graft (CABG) using median sternotomy, CPB, cardioplegia and complete cross-clamp and no associated or concomitant surgical procedures
12017173|NCT00463294|Procedure|Coronary Artery Bypass Graft without the use of CPB|Coronary Artery Bypass Graft (CABG) with no associated or concomitant surgical procedures, using median sternotomy and without CPB and cardioplegia
12017174|NCT00463268|Drug|alendronate|alendronate 70 mg every 2 weeks
12017175|NCT00463268|Dietary Supplement|Calcium/Vitamin D|Calcium 500 mg and vitamin D supplementation according to serum level
12017176|NCT00463268|Drug|placebo|identical placebo every 2 weeks
12017177|NCT00463255|Behavioral|diet|
12017178|NCT00463242|Drug|Agomelatine|Either 25 mg or 50 mg agomelatine orally once daily
12017179|NCT00463242|Drug|paroxetine|
12017180|NCT00463242|Drug|placebo|
12017181|NCT00463229|Other|Interprofessional Team Approach|Subject in the second group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
12017182|NCT00463216|Behavioral|A multidisciplinary diagnostic evaluation|
12017183|NCT00463203|Drug|Bevacizumab|10 mg/kg every 2 weeks
12017184|NCT00463203|Drug|Irinotecan|125 mg/m2 non-EIAED or 340 mg/m2 EIAED every 2 weeks
12017185|NCT00463190|Drug|Biothree|
12017186|NCT00463151|Drug|rebamipide|0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
12017187|NCT00463138|Behavioral|Crisis intervention|
12017188|NCT00463125|Drug|Platelet Gel|
12017189|NCT00463112|Drug|Sibutramine|
12017190|NCT00463086|Drug|isoniazid|A self-administered daily dose of 5mg/kg of Isoniazid or placebo for 12months(300mg if weight is more than or equal to 50kg and 200mg if weight is less than 50kg)
12017191|NCT00463086|Drug|Placebo|A self-administered dose of 5mg/kg of placebo (300mg if weight is more than or equal to 50kg and 200mg if weight is less than 50kg)
12017192|NCT00463073|Drug|Cetuximab|
12017193|NCT00463073|Drug|Bevacizumab|
12017194|NCT00463073|Drug|Irinotecan|
12017195|NCT00463060|Drug|sunitinib malate (Sutent)|Sutent administered PO QD from days 1 to 28 Two weeks after completion of any chemotherapy, maintenance Sutent in 6 week cycles (consisting of Sutent 50 mg PO QD weeks 1-4 followed by no treatment weeks 5-6) until progression or death If no chemotherapy is planned, maintenance Sutent (as described above) will start on day 43.
12017196|NCT00463060|Procedure|radiotherapy|Radiation is to be delivered to each site over 10 fractions separated by at least 16 hours. Up to 5 sites may be treated
12017197|NCT00463047|Drug|Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone|Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.
12017198|NCT00463034|Genetic|microarray analysis|
12017199|NCT00463034|Genetic|polymerase chain reaction|
12017200|NCT00463034|Genetic|polymorphism analysis|
12017201|NCT00463034|Other|high performance liquid chromatography|
12017202|NCT00463034|Other|immunohistochemistry staining method|
12017203|NCT00463034|Other|laboratory biomarker analysis|
12017204|NCT00463034|Other|questionnaire administration|
12017205|NCT00463021|Drug|Hectorol (doxercalciferol capsules)|
12017208|NCT00463008|Other|pharmacological study|
12017209|NCT00462995|Drug|Erlotinib|150mg once a day for 28 days
12017210|NCT00462995|Drug|Erlotinib|28 days of Erlotinib before surgery in patients with stage I-IIb NSCLC
12017211|NCT00462982|Drug|sunitinib malate|
12017212|NCT00462969|Procedure|Sonohysterography|Sonohysterography
12017213|NCT00462956|Drug|Tykerb|lapatinib 1500mg daily
12017214|NCT00462943|Drug|Omacetaxine mepesuccinate|"Induction: 1.25mg/m^2 subcutaneously twice daily for 14 consecutive days, every 28 days.
~Maintenance: 1.25mg/m^2 subcutaneously twice daily for 7 consecutive days, every 28 days.
~Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study."
12017215|NCT00462917|Behavioral|Pleiotropic info, in-person disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
~Genetic counselors communicate results to participants during an in-person disclosure session."
12017216|NCT00462917|Behavioral|AD-only info, in-person disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
~Genetic counselors communicate results to participants during an in-person disclosure session."
12017217|NCT00462917|Behavioral|Pleiotropic info, phone disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
~Genetic counselors communicate results to participants during a telephone disclosure session."
12017218|NCT00462917|Behavioral|AD-only info, phone disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
~Genetic counselors communicate results to participants during an in-person disclosure session."
12017219|NCT00462904|Drug|BPI|BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours
12017220|NCT00462891|Other|IT System|
12017221|NCT00462878|Drug|Meropenem|antibiotic
12017222|NCT00462878|Drug|Vancomycin|Antibiotic
12017223|NCT00462878|Drug|Teicoplanin|Antibiotic
12017224|NCT00462865|Drug|Gemcitabine and Capecitabine and Avastin|avastin administered concurrently with chemotherapy (gemcitabine + capecitabine) for six cycles followed by single agent avastin to complete one year of treatment. Radiation therapy (if planned) will take place after adjuvant chemotherapy completes.
12017225|NCT00462852|Drug|dalteparin|
12017226|NCT00462852|Drug|gemcitabine hydrochloride|
12017227|NCT00462852|Other|diagnostic laboratory biomarker analysis|
12017228|NCT00462839|Procedure|blood loss estimation|Participants were randomized in blocks, by provider type to view either the four calibrated stations or the four non-calibrated stations. The order of the volumes within each set of stations was randomized. Participants received a data card for each station on which they wrote the volume estimated. After each station, the data card was collected. Alterations to the estimations were not allowed once the answers were recorded. Subjects were then crossed over to the other group and asked to estimate the blood volumes in the non-calibrated drapes if they had first viewed the calibrated drape or the calibrated drape if they had viewed the non-calibrated drape. The order of viewing the four volumes was again randomized. The volumes were the same at the corresponding station for the calibrated and non-calibrated stations so the impact of the calibration markings on accuracy could be determined.
12017229|NCT00462826|Biological|ziv-aflibercept|
12017230|NCT00462813|Drug|oral microencapsulated diindolylmethane|
12017231|NCT00462813|Genetic|polymerase chain reaction|
12017232|NCT00462813|Other|cervical Papanicolaou test|
12017233|NCT00462813|Other|cytology specimen collection procedure|
12017234|NCT00462813|Procedure|colposcopic biopsy|
12017235|NCT00462787|Biological|filgrastim|
12017236|NCT00462787|Drug|clofarabine|
12017237|NCT00462787|Drug|dexamethasone|
12017238|NCT00462787|Drug|thiotepa|
12017239|NCT00462787|Drug|topotecan hydrochloride|
12017240|NCT00462787|Drug|vinorelbine tartrate|
12017241|NCT00462774|Procedure|Intramyocardial injection of autologous CD133+ marrow cells|
12017242|NCT00462761|Drug|AC220|Powder in bottle formulation supplied as 50mg or 350 mg in glass, crimped serum vials. Requires reconstitution by a pharmacist, and must be stored securely and protected from light.
12017243|NCT00462748|Drug|ezetimibe (+) simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
12017244|NCT00462748|Drug|Comparator: atorvastatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
12017245|NCT00462748|Drug|Comparator: rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.
12017246|NCT00462735|Drug|Cetuximab|250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients
12017247|NCT00462735|Drug|Hydroxyurea|500 mg orally every 12 hours with the morning dose administered 2 hours before radiation
12017248|NCT00462735|Drug|Fluorouracil|continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours
12017249|NCT00462735|Procedure|radiotherapy|"Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.
~Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients."
12017250|NCT00462722|Drug|Ibuprofen|400 mg with each exercise session (up to 5 days per week) for 9 months
12017251|NCT00462722|Drug|Placebo|with each exercise session (up to 5 days per week) for 9 months
12017252|NCT00462722|Behavioral|musculoskeletal-loading exercise|Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months
12017253|NCT00462709|Biological|C1 esterase inhibitor [human] (C1INH-nf)|
12017254|NCT00462696|Drug|docetaxel|
12017255|NCT00462696|Drug|epirubicin hydrochloride|
12017256|NCT00462696|Procedure|conventional surgery|
12017257|NCT00462696|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
12017258|NCT00462696|Procedure|neoadjuvant therapy|
12017259|NCT00462696|Procedure|radiomammography|
12017260|NCT00462670|Drug|OPC-41061(Tolvaptan)|0, 15mg of OPC-41061 per day for 7days p.o. administration
12017261|NCT00462657|Genetic|polymerase chain reaction|
12017262|NCT00462657|Other|bronchoalveolar lavage|
12017263|NCT00462657|Other|immunoenzyme technique|
12017264|NCT00462657|Other|laboratory biomarker analysis|
12017265|NCT00462657|Procedure|bronchoscopy|
12017266|NCT00462657|Procedure|management of therapy complications|
12017267|NCT00462644|Drug|RSI sedation with etomidate/succinylcholine|etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV
12017268|NCT00462644|Drug|RSI sedation with fentanyl/midazolam/succinylcholine|100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV
12017269|NCT00462631|Device|Paclitaxel Eluting Balloon|Paclitaxel eluting balloon
12017270|NCT00462631|Device|paclitaxel eluting stent|paclitaxel eluting stent
12017271|NCT00462631|Device|bare metal stent|bare metal stent
12017272|NCT00462618|Drug|Quetiapine|
12017273|NCT00462618|Behavioral|Cogntive behavioral therapy|
12017274|NCT00462605|Drug|entinostat|Given PO
12017275|NCT00462605|Drug|sargramostim|Given SC
12017276|NCT00462592|Drug|budesonide|inhaled budesonide turbuhaler 200ug taken 1 puff morning & 1 puff evening.
12017277|NCT00462592|Drug|montelukast|montelukast 5 mg ( < 15 years) or 10 mg (and matching placebo)will be taken 1 tab in the evening
12017278|NCT00462592|Other|placebo|placebo
12017279|NCT00462566|Device|motor cortex stimulation|
12017280|NCT00462553|Drug|sunitinib malate|Given orally
12017281|NCT00462553|Drug|gemcitabine hydrochloride|Given IV
12017282|NCT00462540|Drug|Formoterol Fumurate inhalation solution 20 mcg|
12017283|NCT00462540|Drug|Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg|
12017284|NCT00462501|Biological|bevacizumab|
12017285|NCT00462501|Drug|fluorouracil|
12017286|NCT00462501|Drug|leucovorin calcium|
12017287|NCT00462501|Drug|oxaliplatin|
12017288|NCT00462501|Procedure|conventional surgery|
12017289|NCT00462501|Radiation|radiation therapy|
12017290|NCT00462488|Drug|Vicinium|Intravesical administration of Vicinium
12017291|NCT00462475|Drug|Recombinant Growth Hormone, Genotropin (Pfizer)|
12017292|NCT00462462|Drug|Ethanol 96% Gel|
12017293|NCT00462462|Drug|Ethanol 98% Solution|
12017294|NCT00462449|Device|Functional Electrical Stimulation (FES) through the Ness H200|Specialized exercises will be presented to the participants in this group. They will be instructed on how to attach and complete this exercise program utilizing the FES device.
12017295|NCT00462436|Behavioral|Consumption of Dietary Portfolio|The study involves following an aggressive low fat diet that is high in viscous fiber, nuts and soy protein. The diet is individually tailored to meet individual participants needs.
12017296|NCT00462423|Drug|Avastin|Avastin 10 mg/kg IV every 2 weeks (without rest period).
12017297|NCT00462423|Drug|Abraxane|Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle.
12017298|NCT00462410|Other|counseling intervention|
12017299|NCT00462410|Procedure|psychosocial assessment and care|
12017300|NCT00462397|Drug|carboplatin|
12017301|NCT00462397|Drug|cisplatin|
12017302|NCT00462397|Drug|paclitaxel|
12017303|NCT00462397|Procedure|neoadjuvant therapy|
12017304|NCT00462397|Radiation|brachytherapy|
12017305|NCT00462397|Radiation|radiation therapy|
12017306|NCT00462384|Drug|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
12017307|NCT00462371|Device|Insulin pump (CSII)|
12017308|NCT00462358|Drug|ARRY-520, KSP(Eg5) inhibitor; intravenous|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
12017309|NCT00462358|Drug|Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous|Part 1: standard of care; Part 2: standard of care.
12017310|NCT00462345|Drug|rituximab|1000 mg i.v. on Days 1 and 15
12017311|NCT00462345|Drug|Methotrexate|10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24
12017312|NCT00462345|Drug|Corticosteroid or NSAID|≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24
12017313|NCT00462345|Dietary Supplement|Folate|≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24
12017314|NCT00462332|Drug|Fludarabine|Induction therapy
12017315|NCT00462332|Drug|Campath|Induction therapy
12017316|NCT00462332|Procedure|Transplant|Post-induction therapy
12017317|NCT00462332|Drug|Campath|Post-induction therapy
12017318|NCT00462332|Drug|Fludarabine|Induction therapy
12017319|NCT00462332|Drug|Campath|Induction therapy
12017320|NCT00462332|Drug|Campath|Post-induction therapy
12017321|NCT00462319|Behavioral|Education, weight reduction and physical exercise|
12017322|NCT00462306|Procedure|Survey: Berlin questionnaire|Completion of questionnaire
12017323|NCT00462280|Drug|lovastatin|Given PO
12017324|NCT00462280|Other|placebo|Given PO
12017325|NCT00462280|Procedure|biopsy|Correlative studies
12017326|NCT00462280|Procedure|laboratory biomarker analysis|Correlative studies
12017327|NCT00462267|Behavioral|Enriched lifestyle intervention|Multi-component lifestyle intervention
12017328|NCT00462254|Drug|ROZEREM|8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
12017329|NCT00462254|Drug|Ramelteon|8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).
12017358|NCT00462007|Drug|Stalevo|Oral 3-4 daily doses for 6 weeks
12017359|NCT00461994|Behavioral|diet|
12017360|NCT00461994|Behavioral|exercise|
12017361|NCT00461994|Behavioral|diet and exercise|
12017362|NCT00461981|Biological|TIV, Trivalent Inactivated Influenza Virus Vaccine|0.25 mL will be administered intramuscularly for each of two doses
12018025|NCT00456365|Drug|Placebo|Placebo daily
12017330|NCT00462241|Procedure|chiropractic treatment|Participants in the therapy group undergo a physical examination by an experienced, primary sector chiropractor, lasting up to one hour. The chiropractors choose an individual treatment strategy based on a combination of their findings, the patient history, and a standardized protocol reflecting routine practice. The standardized treatment protocol includes high velocity, low amplitude manipulation directed towards the thoracic and/or cervical spine in combination with any of the following: Joint mobilisation, soft tissue techniques, stretching, stabilising or strengthening exercises, heat or cold treatment, and advice. The protocol specifies up to ten treatment sessions of approximately 20 minutes, 1-3 times per week, or treatment until the patient is pain free. The chiropractors record the types of treatment rendered at sessions.
12017331|NCT00462241|Other|Self-management|Advice group: Advice is directed towards promoting self-management. The participants are told that their chest pain generally has a benign, self limiting course. The participants receive individual instructions regarding posture and two or three exercises aiming to increase spinal or muscle stretch based on clinical evaluation. They are advised to seek medical attention for re-evaluation (general physician, chest pain clinic or emergency department) in case of severe or unfamiliar chest pain. The session lasts on average 15 minutes. Further, the advice group is also asked not to seek any manual treatment for the next four weeks.
12017332|NCT00462228|Drug|Memantine|After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study.
12017333|NCT00462228|Drug|Placebo|After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study.
12017334|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Vietnam/1203/2004
12017335|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Vietnam/1203/2004
12017336|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Indonesia/05/2005
12017337|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Indonesia/05/2005
12017338|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 12-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
12017339|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 24-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
12017340|NCT00462202|Drug|sulodexide|
12017341|NCT00462189|Drug|Immunotoxin therapy|
12017342|NCT00462189|Drug|CAT-8015 Immunotoxin|
12017343|NCT00462189|Procedure|Biological therapy|
12017344|NCT00462176|Procedure|multidisciplinary laparoscopy|Laparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon.
12017345|NCT00462176|Other|Questionnaires|All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire, visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).
12017346|NCT00462150|Behavioral|home-based emotional disclosure|
12017347|NCT00462150|Behavioral|time management control condition|
12017348|NCT00462137|Procedure|Sleep Studies|
12017349|NCT00462124|Device|Absorbable perirectal spacer|biodegradable balloon implant to increase the distance between prostate and anterior rectal wall
12017350|NCT00462111|Drug|Indometacin|
12017351|NCT00462098|Device|hyperbaric oxygen|40 sessions of 100% oxygen at 2 atmospheres of pressure for 2 hours each
12017352|NCT00462098|Device|non-treated control group|no change from routine care, no HBO
12017353|NCT00462072|Drug|Infliximab|Subjects will be on a stable dose of methotrexate 12.5 to 20 mg per week and will be started on infliximab 5 mg/kg.
12017354|NCT00462059|Behavioral|Treatment|
12017355|NCT00462046|Drug|Berberine|
12017356|NCT00462020|Drug|5 days of IV antibiotics (ceftriaxone and metronidazole)|5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing)
12017357|NCT00462020|Drug|Home with oral antibiotics when eating (ampicillin/clavulanic acid)|Augmentin 40mg/kg BID when tolerating POs to complete 7 days total
12017363|NCT00461981|Biological|FluMist, Influenza Virus Vaccine Live|0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
12017364|NCT00461968|Drug|Ezetimibe and Simvastatin|
12017365|NCT00461955|Procedure|autologous peripheral blood stem cell transplantation, ex vivo amplified|autologous peripheral blood stem cell transplantation, ex vivo amplified
12017366|NCT00461942|Drug|Green Tea Polyphenols (EGCG/ECG)|
12017367|NCT00461929|Procedure|bone marrow aspiration|
12017368|NCT00461916|Drug|Half-Dose Depot Triptorelin|
12017369|NCT00461916|Drug|Reduced-Dose Daily Buserelin|
12017370|NCT00461903|Drug|Perindopril|Perindopril 4 mg or matching placebo , 1 tablet administrated once daily for the first 2 weeks. If tolarable, dosage increased to 8mg/day until the end of the study (
12017371|NCT00461890|Drug|Injectable Naltrexone|
12017372|NCT00461864|Procedure|ultrasound examination of the hip|
12017373|NCT00461851|Drug|Gemcitabine|Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
12017374|NCT00461851|Drug|Carboplatin|Carboplatin will be given on day 1 to an AUC of 5.
12017375|NCT00461851|Drug|Sorafenib|Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
12017376|NCT00461838|Procedure|multidisciplinary laparoscopy|Multidisciplinary (with active involvement of the colorectal surgeon/urologist) fertility-sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis.
12017377|NCT00461838|Other|Questionnaires|Patients (n=56) were asked to complete questionnaires regarding quality of life (QOL), pain, fertility and sexuality to compare their status before and after surgery, and their medical files were analyzed.
12017378|NCT00461825|Drug|Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups|
12017379|NCT00461825|Drug|Group A: CsA + Azathioprine(1 to 2 mg/kg/day)|
12017380|NCT00461825|Drug|Group B: CsA + CellCept(500 mg x 2/day)|
12017381|NCT00461825|Drug|Group C: CsAm|
12017382|NCT00461812|Drug|Mometasone|
12017383|NCT00461812|Drug|Advair|
12017384|NCT00461799|Drug|orlistat|
12017385|NCT00461786|Drug|pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
12017386|NCT00461773|Drug|Letrozole|Letrozole 2.5 mg po qd
12017387|NCT00461773|Drug|Bevacizumab|bevacizumab 10 mg/kg IV
12017388|NCT00461760|Procedure|Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive|See Detailed Description.
12017389|NCT00461760|Procedure|Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive|See detailed description.
12017390|NCT00461747|Drug|VBMCP/VBAD/Velcade|"VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalan, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.
~VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20."
12017391|NCT00461747|Drug|Thalidomide/Dexamethasone|"Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity < grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.
~Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days"
12017392|NCT00461747|Drug|Velcade/Thalidomide/Dexamethasone|"Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is < grade 2, the dose increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.
~Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.
~Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days"
12017393|NCT00461734|Other|RV lead placement site|Patients randomised to RV apical or high septal lead placement site
12017394|NCT00461708|Drug|Erlotinib|100 mg, PO, once per day
12017395|NCT00461708|Drug|Gemcitabine|1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
12017396|NCT00461695|Biological|Vaccination against TBEV (FSME Immun CC)|Intramuscular injection into the left (or right) deltoid muscle of 0.5 ml FSME Immun CC for adults (2.4 ug of formalin inactivated TBEV antigen) at time point 0, after 4 weeks and after 24 weeks.
12017397|NCT00461682|Drug|SB-705498|
12017398|NCT00461669|Procedure|ultrasound examination of the hip|
12017399|NCT00461656|Drug|Preoperative conjunctival irrigation with 5% or 1.25% PI|Before initiation of surgery, children will have their conjunctival fornices irrigated with 5 ml PI 5% or with 5 ml PI 1.25%
12017400|NCT00461643|Drug|Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins|
12017401|NCT00461630|Drug|ER niacin/laropiprant|
12017402|NCT00461630|Drug|simvastatin|40 mg simvastatin tablet orally per day as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level
12017403|NCT00461630|Drug|ezetimibe/simvastatin|10 mg ezetimibe plus 40 mg simvastatin in single tablet taken once daily as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level
12017404|NCT00461617|Drug|Mitiglinide|10mg tablet, 10mg TID
12017405|NCT00461591|Drug|Apaziquone|A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
12017406|NCT00461591|Drug|Placebo|A single intravesical dose of placebo instilled into the bladder post-TURBT
12017407|NCT00461591|Procedure|TURBT|TransUrethral Resection of the Bladder Tumor
12017408|NCT00461578|Drug|Chlorproguanil-dapsone + artesunate|
12017409|NCT00461565|Drug|Sildenafil|A1) Two dosis of 200 mg Sildenafil orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
12017410|NCT00461565|Drug|Placebo|A2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
12017411|NCT00461565|Drug|Vardenafil (Levitra, BAY38-9456)|B1) At least 15 dosis of 20 mg Levitra orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
12017412|NCT00461565|Drug|Placebo|B2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
12017413|NCT00461552|Drug|Leptin|weight based, sub-cutaneous injection, twice daily
12017414|NCT00461552|Other|Placebo|weight based, sub-cutaneous injection, twice daily
12017618|NCT00459810|Drug|transdermal estradiol|Transdermal estradiol given 0.2mg/day for duration of study.
12017415|NCT00461539|Other|Treatment as usual|Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.
12017416|NCT00461539|Behavioral|Behavioral health intervention|Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention.
12017417|NCT00461526|Drug|crofelemer|125 mg crofelemer vs. placebo
12017418|NCT00461513|Behavioral|Intervention|Disease management has emerged as a promising strategy to improve the outcomes of patients with CHF. Disease management in this study will use a multidisciplinary collaborative care, leveraging health information technology, and focusing on patient self-care.Collaborative care is the use of multidisciplinary teams to deliver evidence-based treatment to a defined population of patients with chronic illness.
12017419|NCT00461500|Drug|Salmeterol xinafoate/fluticasone propionate combination|SFC 100
12017420|NCT00461500|Drug|Fluticasone propionate|FP 100
12017421|NCT00461487|Behavioral|Active control on hygiene and nutrition|The active control group will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. The mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the active control on hygiene and nutrition will be delivered to the mother.
12017422|NCT00461487|Behavioral|Families Talking Together|The intervention will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. A mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. There will be three follow-up booster sessions administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
12017423|NCT00461474|Behavioral|Shoulder strengthening exercises|
12017424|NCT00461474|Behavioral|Movement Optimization|
12017425|NCT00461461|Procedure|meeting nurses / physicians, quality improvement sessions|"For each iatrogenic indicator, the interventions are:
~Meeting with the ICU staff to discuss the epidemiology of patients on each theme.
~Pocket card with guidelines on the theme and ICU protocol in each study ICU.
~Feedback meeting twice a month on errors in the unit, preventability, and appropriate changes in procedures on the subject."
12017426|NCT00461448|Dietary Supplement|Potassium supplement|Patients were randomly allocated to receive either an EGJ containing 234.5 mmol microcrystalline KCl a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily) or PGJ for 28 days.
12017427|NCT00461435|Procedure|hyperbaric oxygen therapy|
12017428|NCT00461422|Drug|Ganirelix|sc injection of Ganirelix 0.25 mg per day
12017429|NCT00461396|Drug|Interferon-1beta (Betaseron, BAY86-5046)|Male and females, 18 to 50 years of age, after a first clinical demyelinating event suggestive of multiple sclerosis or with onset of RRMS within the past 12 months
12017430|NCT00461370|Drug|SRX251|
12017431|NCT00461344|Drug|Docetaxel|
12017432|NCT00461344|Drug|Doxorubicin|
12017433|NCT00461331|Drug|Insulin Aspart|Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.
12017434|NCT00461331|Drug|Insulin Lispro|Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
12017435|NCT00461318|Procedure|Individual placement and support (vocational rehabilitation)|
12017436|NCT00461305|Drug|DRSP 3 mg/EE 20 µg (13 cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
12017437|NCT00461305|Drug|DRSP 3 mg/EE 30 µg (6 cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
12017438|NCT00461292|Biological|botulinum toxin Type A (200U)|botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection > Week 12; injections into detrusor
12017439|NCT00461292|Biological|botulinum toxin Type A (300U)|botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
12017440|NCT00461292|Other|Normal saline (Placebo); botulinum toxin Type A (200U)|Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks; injections into detrusor
12017441|NCT00461292|Other|Normal saline (Placebo); botulinum toxin Type A (300U)|Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
12017442|NCT00461279|Behavioral|Cognitive Behavior Therapy|Reframing and understanding cognitions of depression
12017443|NCT00461279|Behavioral|Interpersonal Psychotherapy|Established psychotherapy for depression
12017444|NCT00461266|Drug|enfuvirtide [Fuzeon]|90mg sc bid
12017445|NCT00461266|Drug|Antiretroviral therapy|As prescribed
12017446|NCT00461253|Device|Levonorgestrel-releasing IUD|"This is a case-control-study; strictly speaking the category intervention type does not apply to this study."
12017447|NCT00461253|Device|Copper IUD|"This is a case-control-study; strictly speaking the category intervention type does not apply to this study."
12017448|NCT00461214|Other|Participation in laparoscopic training curriculum|General Surgery Training Outcome
12017449|NCT00461201|Procedure|Nurse practitioner care of patients|
12017498|NCT00460707|Drug|Casopitant 150 mg|Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.
12017833|NCT00458120|Biological|Placebo to rDEN1delta30 or rDEN2/4delta30(ME)|Placebo vaccines for rDEN1delta30 and rDEN2/4delta30(ME)
12017834|NCT00458107|Drug|SCA-136|
12017450|NCT00461162|Behavioral|Internet DSMP|Internet Dyspnea Self-management Program (i-DSMP): Education and skills training for dyspnea management; an individualized tailored exercise plan; self-monitoring of exacerbation symptoms and exercise; and reinforcement/personalized feedback for self management. I-DSMP participants will receive their accessing the modules through the website and participating in weekly online group chat sessions with the research nurse and other participants.
12017451|NCT00461162|Behavioral|Face-to-Face Dyspnea Self-management|Face-to-Face Dyspnea Self-management Program (f-DSMP): Education and skills training for dyspnea management; an individualized tailored exercise plan; self-monitoring of exacerbation symptoms and exercise; and reinforcement/personalized feedback for self management. F-DMSP participants will attend face-to-face group education sessions. The f-DSMP participants will be provide with a hard copy of the education modules and will participate in six 1-hour group sessions for a period of 6 weeks.
12017452|NCT00461162|Behavioral|Attention Control|6 Monthly general health education classes and biweekly telephone calls from a health educator.
12017453|NCT00461149|Drug|Octreotide-LAR|
12017454|NCT00461136|Drug|Aliskiren|
12017455|NCT00461123|Drug|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
12017456|NCT00461123|Drug|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
12017457|NCT00461110|Drug|BMS-663513|mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks
12017458|NCT00461097|Drug|Egg oral immunotherapy|Egg white solid powder
12017459|NCT00461097|Drug|Control Group|Placebo for egg white solid
12017460|NCT00461084|Drug|BIAXIN (CLARITHROMYCIN)|Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
12017461|NCT00461084|Drug|Biaxin (clarithromycin)|Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
12017462|NCT00461071|Behavioral|Guided Self-help for Bulimia nervosa|bibliotherapy
12017463|NCT00461058|Drug|Actos|Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
12017464|NCT00461058|Drug|aleglitazar|Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
12017465|NCT00461045|Drug|MRZ 0.5 mg/m^2|NPI-0052 0.5 mg/m2 administered IV over 2 hours on Days 1, 4, 8, and 11 in each 21-day cycle
12017466|NCT00461032|Drug|montelukast|montelukast 5 mg tablet Once a day (QD) for 8 weeks
12017467|NCT00461032|Drug|Comparator: Placebo|Placebo to montelukast QD for 8 weeks
12017468|NCT00461019|Procedure|Implantation and activation of the vagus nerve stimulator|Implantation of the nerve stimulator, cuff nerve electrode and RV sensing lead
12017469|NCT00461006|Drug|Actos|45mg po daily
12017470|NCT00461006|Drug|aleglitazar|0.6mg po daily
12017471|NCT00460993|Drug|Lunesta|"Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4.
~Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4."
12017472|NCT00460980|Behavioral|Virtual reality laparoscopic simulator training|The aim of this project is to determine whether a structured approach to teaching laparoscopic skills to beginning surgeons with a virtual reality trainer will improve skills prior to actual operative experience. We aim to show that with the virtual reality trainer, operative skills will be improved and that overall operative time will be decreased.
12017473|NCT00460967|Device|Rheopheresis|8 rheopheresis treatments over 10 wks.
12017474|NCT00460967|Device|Rheopheresis|Sham treatment
12017475|NCT00460954|Drug|Sinemet® controlled release (Carbidopa/levodopa)|
12017476|NCT00460941|Drug|Placebo|sc weekly
12017477|NCT00460941|Drug|Taspoglutide 20mg|sc weekly
12017478|NCT00460941|Drug|Taspoglutide 20mg-30mg|sc weekly
12017479|NCT00460941|Drug|Taspoglutide 20mg-40mg|sc weekly
12017480|NCT00460928|Drug|intravenous immune globulin (IVIG)|
12017481|NCT00460915|Drug|Lacidipine & Amlodipine|
12017482|NCT00460902|Device|Transcranial Magnetic Stimulation (TMS)|
12017483|NCT00460889|Procedure|donor nephrectomy|The objective of this protocol is to look at the outcomes of laparoscopic donor nephrectomy performed by using hand assisted (HA)or entirely laparoscopic (LDN) surgical techniques. To define the advantages of each technique, we will use records of patients who underwent laparoscopic live kidney donation with HALDN.
12017484|NCT00460876|Drug|Topotecan|
12017485|NCT00460863|Procedure|using cool versus warm dialysate during hemodialysis|
12017486|NCT00460850|Drug|peginterferon alfa-2a (40KD) [PEGASYS]|180 micrograms sc weekly for 48 weeks
12017487|NCT00460837|Drug|bowel preparation: senna & gastrofin versus picolax (standard)|The intervention is a bowel cleansing procedure
12017488|NCT00460811|Drug|Linaclotide Acetate|Oral, once daily
12017489|NCT00460811|Drug|Matching placebo|Oral, once daily
12017490|NCT00460798|Other|Sutent: observational study|SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
12017491|NCT00460785|Drug|Opioid|
12017492|NCT00460759|Drug|Moxifloxacin|
12017493|NCT00460759|Drug|Rifapentine|
12017494|NCT00460746|Drug|TMC125, Darunavir; Ritonavir|TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;
12017495|NCT00460733|Drug|Risedronate sodium|Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
12017496|NCT00460733|Drug|Calcium & Vitamine D3|1000 mg of calcium and 400 UI of Vitamine D3
12017497|NCT00460720|Other|Observational treatment compliance survey|Observational treatment compliance survey
12017615|NCT00459836|Other|laboratory biomarker analysis|
12017499|NCT00460707|Drug|Ketoconazole|Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days).
12017500|NCT00460707|Drug|Casopitant 150 mg matching placebo|Casopitant 150 mg matching placebo will be available as white, film-coated tablets.
12017501|NCT00460707|Drug|Casopitant 50 mg|Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach.
12017502|NCT00460707|Drug|Casopitant 50 mg matching placebo|Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.
12017503|NCT00460694|Biological|infusion of allogeneic CIK cells|infusion of allogeneic CIK cells at graded doses
12017504|NCT00460681|Drug|Thymopentin|subcutaneously or intramuscular inject at the dosage of 10 mg every second day (twice a week) for consecutive 3 months.
12017505|NCT00460668|Behavioral|pulmonary rehabilitation|2 or 3 times a week during 8 weeks
12017506|NCT00460655|Drug|GSK1358820|botulinum toxin type A
12017507|NCT00460655|Drug|Placebo|Placebo
12017508|NCT00460642|Drug|GnRH Antagonist (Cetrotide)|
12017509|NCT00460629|Procedure|Application of activated donor T cells|Ex-vivo generated donor T cells stimulated by antigen presenting cells loaded with peptides derived from leukemia-associated antigens
12017510|NCT00460616|Drug|Cabergoline|According with our previous studies, in the patients with microprolactinoma and in those with non-tumoral hyperprolactinemia, cabergoline treatment was administered orally at a starting dose of 0.25 mg twice weekly for the first two weeks and then 0.5 mg twice weekly. After 2 months of treatment, dose adjustment was carried out every 2 months on the basis of serum PRL suppression.
12017511|NCT00460603|Drug|bevacizumab|bevacizumab 5 mg/kg every 2 weeks
12017512|NCT00460603|Drug|AG-013726|AG-013726 5 mg bid every 2 weeks
12017513|NCT00460603|Drug|AG-013736 (axitinib)|AG-013736 5 mg bid starting dose
12017514|NCT00460590|Biological|MVA 85A|ID vaccine
12017515|NCT00460577|Drug|Formoterol fumerate|12 micrograms stat (twice if necessary). Inhaled via aerolizer
12017516|NCT00460577|Drug|fenoterol/ipratropium bromide|0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.
12017517|NCT00460564|Drug|GSK1358820|botulinum toxin type A
12017518|NCT00460564|Drug|Placebo|Placebo
12017519|NCT00460551|Biological|Zalutumumab|8 mg/kg
12017520|NCT00460551|Drug|Induction chemotherapy|Combination of cisplatin and docetaxel administered as two cycles given every three weeks
12017521|NCT00460551|Radiation|Radiotherapy|64 Gy in 32 fractions over 6.5 weeks
12017522|NCT00460538|Dietary Supplement|Lectranal|"Dosage form: capsule
~1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks"
12017523|NCT00460538|Dietary Supplement|placebo|Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks
12017524|NCT00460525|Biological|FMP2.1/AS02A|3 doses administered a month apart: 50 µg recombinant subunit protein FMP2.1 (Plasmodium falciparum Apical Membrane Antigen-1 from strain 3D7 expressed in and purified from Escherichia coli), adjuvanted with 0.5 mL of AS02A (proprietary oil-in-water emulsion and phosphate buffered saline with the immunostimulants monophosphoral lipid A and QS21).
12017525|NCT00460525|Biological|Rabies Vaccine|White, freeze-dried vaccine for reconstitution with the diluent prior to use; dosage 1.0 mL of rabies vaccine.
12017526|NCT00460512|Drug|Paliperidone ER|Paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons.
12017527|NCT00460499|Drug|A IV Insulin drip|These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.
12017528|NCT00460499|Drug|B Low Dose GIK|These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl
12017529|NCT00460499|Drug|C High Dose GIK|This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl
12017530|NCT00460486|Biological|Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|
12017531|NCT00460473|Drug|Dexmedetomidine|
12017532|NCT00460473|Drug|Placebo|
12017533|NCT00460460|Drug|AZD4877|
12017534|NCT00460447|Drug|Gemtuzumab Ozogamicin|
12017535|NCT00460434|Device|TVT|Prophylactic TVT
12017536|NCT00460434|Other|Sham|Sham TVT
12017537|NCT00460421|Drug|Palifermin|Palifermin will be administered as an IV bolus injection (40, 60 or 80 µg/kg/day)once daily for 3 consecutive days before the start of conditioning regimen and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively).
12017538|NCT00460421|Radiation|Total Body irradiation|
12017539|NCT00460421|Drug|Chemotherapy|High dose etoposide, Cyclophosphamide
12017540|NCT00460408|Drug|Macugen|Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
12017541|NCT00460395|Procedure|Surgery|
12017542|NCT00460395|Procedure|Stereotactic radiosurgery|
12017543|NCT00460382|Drug|raltegravir potassium|400 mg twice a day
12017544|NCT00460382|Drug|darunavir/ritonavir|2 pills of 300 mg twice a day
12017545|NCT00460382|Drug|etravirine|2 pills of 100 mg twice a day
12017546|NCT00460382|Drug|Optimized background regimen|NRTIs and or enfuvirtide (investigator choice)
12017547|NCT00460369|Drug|sulfadoxine-pyrimethamine|"tablets 1,25/25 mg
~1 tablet per 20 kg of body weight Single drug intake"
12017548|NCT00460369|Drug|artemether-lumefantrine|"tablets 20/120 mg
~1 tablet twice daily for 3 days below 15 kg of bodyweight
~2 tablets twice daily for 3 days below 24 kg of bodyweight
~3 tablets twice daily for 3 days below 35 kg of bodyweight"
12017549|NCT00460369|Drug|amodiaquine-artesunate coformulation|"one 25mg/67,5mg tablet, once daily for 3 days below 9 kg
~one 50/135mg tablet, once daily for 3 days below 18 kg"
12017550|NCT00460356|Other|Laboratory Biomarker Analysis|Correlative studies
12017551|NCT00460356|Procedure|Lymphadenectomy|Undergo lymphadenectomy
12017616|NCT00459836|Other|pharmacological study|
12017617|NCT00459823|Drug|E7107|E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.
12017889|NCT00457678|Drug|Visudyne|
12017552|NCT00460343|Other|extensive implementation programme|experimental pharmacists follow an extensive implementation programme. They attend two interactive half a day educational meetings tailored to individual needs: one at start of the intervention, and one in May or September 2007. Special attention is given to multiprofessional cooperation with general practitioners and nurse practitioners. Additionally, guided by their own project planning pharmacists receive three or more telephone calls, both as a reminder, feedback, and in order to investigate whether they need any more help.
12017553|NCT00460343|Other|control|pharmacists only receive a written manual with instructions to implement the patient compliance intervention.
12017554|NCT00460317|Drug|AMG 706|125 mg QD orally every day
12017555|NCT00460317|Drug|placebo|125 mg QD orally every day
12017556|NCT00460317|Drug|paclitaxel|200mg/m2 on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles
12017557|NCT00460317|Drug|carboplatin|AUC of 600mg/mL x min by Calvert formula on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles
12017558|NCT00460304|Drug|pramlintide|
12017559|NCT00460304|Procedure|continuous glucose monitoring|
12017560|NCT00460291|Device|Implantation of the ProVena vein graft during bypass surgery|
12017561|NCT00460278|Drug|XL418|
12017562|NCT00460265|Drug|ARM 2|Subjects will receive Cisplatin plus 5FU
12017563|NCT00460265|Drug|ARM 1|Subjects will receive Panitumumab plus cisplatin and 5FU
12017564|NCT00460252|Procedure|insulin titration applying a computer algorithm|
12017565|NCT00460239|Drug|Buprenorphine|Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week.
12017566|NCT00460239|Drug|Morphine|Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind
12017567|NCT00460239|Drug|Placebo|Intramuscular; double blind; once per week
12017568|NCT00460226|Drug|lamotrigine|lamotrigine treatment for 12weeks
12017569|NCT00460213|Drug|Valsartan 80mg daily|
12017570|NCT00460213|Drug|Valsartan 160mg daily|
12017571|NCT00460200|Genetic|polymorphism analysis|
12017572|NCT00460200|Other|laboratory biomarker analysis|
12017573|NCT00460200|Other|physiologic testing|
12017574|NCT00460200|Other|questionnaire administration|
12017575|NCT00460200|Procedure|conventional surgery|
12017576|NCT00460200|Procedure|fatigue assessment and management|
12017577|NCT00460200|Procedure|psychosocial assessment and care|
12017578|NCT00460187|Device|Percutaneous intervention of the carotid artery|
12017579|NCT00460174|Biological|bevacizumab|10 mg/kg every 2 weeks as an intravenous infusion after gemcitabine and before radiation
12017580|NCT00460174|Drug|gemcitabine|1000 mg/m2, 30 minute intravenous infusion, cycle 1 (weeks 1, 2), cycle 2 (weeks 4, 5, 6) and cycle 3 (weeks 8 and 9). During cycle 2, gemcitabine will be delivered prior to radiation therapy
12017581|NCT00460174|Procedure|conventional surgery|If resectable, patients will undergo surgery no less than 6 weeks following last dose of bevacizumab. Unresectable patients will not undergo surgery.
12017582|NCT00460174|Radiation|radiation therapy|2.4 Gy fractions, 5 fractions/week during cycle 2 only (weeks 4, 5, 6). Total dose 36 Gy.
12017583|NCT00460161|Procedure|acupuncture|2 treatments/week for 4 weeks
12017584|NCT00460161|Other|placebo/sham acupuncture|2 treatments/week for 4 weeks
12017585|NCT00460148|Drug|Ropinirole|
12017586|NCT00460135|Behavioral|resistance training|2 times a week resistance training
12017587|NCT00460109|Biological|denileukin diftitox|
12017588|NCT00460109|Biological|rituximab|
12017589|NCT00460096|Drug|Kamada-API|
12017590|NCT00460083|Drug|Elidel(R) (pimecrolimus 1%)|
12017591|NCT00460083|Device|EpiCeram(R) -ceramide based barrier repair cream|
12017592|NCT00460057|Drug|Alendronate|Take two tablets (alendronate 10 mg) once weekly with a full glass of plain water in the morning after an overnight fast and to refrain from lying down or taking any other beverage or food for at least 1 h thereafter
12017593|NCT00460031|Drug|ketoconazole|400 tid
12017594|NCT00460031|Drug|lenalidomide|Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
12017595|NCT00460031|Drug|therapeutic hydrocortisone|20mg qam 10mg qhs
12017596|NCT00460018|Behavioral|Diet, Exercise, and Breastfeeding Intervention|"Phase I (Pregnancy Program from GDM diagnosis to delivery): One in-person session with the lifestyle coach, two phone calls with the lifestyle coach, and one in-person session with the lactation consultant
~Phase II (Early Post-partum Period from delivery to 6 weeks post-partum): Two to four routine phone calls with the lactation consultant
~Phase III (Late Post-partum Period 6 weeks to 7 months postpartum): Two in-person sessions with the lifestyle coach, up to 11 phone calls with the lifestyle coach, and two to three routine calls with the lactation consultant
~Phase IV (Maintenance Phase 8 months to 1 year postpartum): One newsletter from the lifestyle coaches, two recipe letters and continue calls with the lifestyle coach (optional)"
12017597|NCT00459992|Drug|Betahistine Hydrochloride|
12017598|NCT00459979|Drug|sunitinib malate|Sunitinib will be dosed at 50 mg p.o. daily
12017599|NCT00459979|Procedure|conventional surgery|nephrectomy
12017600|NCT00459966|Procedure|Preoperative rehabilitation|
12017601|NCT00459953|Drug|Extended treatment|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
12017602|NCT00459940|Drug|Pioglitazone|
12017603|NCT00459927|Device|Floseal tonsillectomy|
12017604|NCT00459927|Device|Coblation tonsillectomy|
12017605|NCT00459914|Device|cpap treatment during sleep|CPAP
12017606|NCT00459901|Drug|Erlotinib and capecitabine|
12017607|NCT00459888|Device|PolarCath Peripheral Dilatation System (Boston Scientific)|
12017608|NCT00459875|Drug|sunitinib malate|
12017609|NCT00459862|Other|laboratory biomarker analysis|Correlative study
12017610|NCT00459862|Drug|pazopanib hydrochloride|Given orally
12017611|NCT00459849|Procedure|Intraoperative ultrasonography|Intraoperative ultrasonography will be used to determine plaque placement.
12017612|NCT00459836|Drug|PR-104|
12017613|NCT00459836|Drug|docetaxel|
12017614|NCT00459836|Drug|gemcitabine hydrochloride|
12017619|NCT00459810|Drug|paclitaxel poliglumex|Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2
12017620|NCT00459797|Device|Conventional (reusable) Glidescope|
12017621|NCT00459797|Device|Single-use Glidescope videolaryngoscope|
12017622|NCT00459784|Procedure|Dementia Training Program|
12017623|NCT00459771|Drug|AT1 blocker candesartan|AT1 blocker candesartan, 32 mg oral QD
12017624|NCT00459771|Drug|Placebo|Placebo, 32 mg, oral QD
12017625|NCT00459758|Device|Hans unit|
12017626|NCT00459745|Drug|Pravafen|
12017627|NCT00459745|Drug|Pravastatin|
12017628|NCT00459745|Drug|Fenofibrate|
12017629|NCT00459732|Dietary Supplement|Zinc|25 mg of elemental zinc as zinc sulphate take once daily for 18 months
12017630|NCT00459732|Dietary Supplement|Placebo|Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months
12017631|NCT00459719|Drug|Tacrolimus modified-release|oral
12017632|NCT00459719|Drug|Prograf|oral
12017633|NCT00459706|Device|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
12017634|NCT00459706|Device|Enbrel 50 mg Autoinjector|Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
12017635|NCT00459693|Drug|[11C]PBR28|
12017636|NCT00459680|Device|Laser acupoint treatment|Laser
12017637|NCT00459680|Procedure|Acupuncture|Needle acupuncture on ST36 and LI11.
12017638|NCT00459667|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
12017639|NCT00459667|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
12017640|NCT00459667|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|"Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.
~Phase B: All patients will receive 500µg s.c.every other day (open-label)."
12017641|NCT00459654|Drug|Radium-223 dichloride (BAY88-8223)|Four Radium-223 injections were given at 4-weekly intervals starting after the first fraction of EBR.
12017642|NCT00459654|Drug|Saline|Four Saline injections were given at 4-weekly intervals starting after the first fraction of EBR.
12017643|NCT00459641|Drug|I-040302|doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
12017644|NCT00459641|Other|Standard of Care|Bone marrow aspirate or steroids
12017645|NCT00459628|Radiation|Conventional radiotherapy|Radiation treatment delivered by conventional linear accelerator using matching fields
12017646|NCT00459628|Radiation|Tomotherapy|CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system
12017647|NCT00459615|Drug|Artesunate for Injection|
12017648|NCT00459589|Behavioral|nutritional intervention with dietician plus usual nutritional care|nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d
12017649|NCT00459589|Behavioral|usual nutritional care|usual nutritional care
12017650|NCT00459563|Drug|Vitamin D|200,000 IU once weekly for 3 weeks (600,000 IU total dose)
12017651|NCT00459563|Drug|calcitriol|calcitriol 0.5 mcg twice a day for 1 week
12017652|NCT00459563|Drug|Placebo|Placebo once a week for 3 weeks
12017653|NCT00459550|Drug|GSK933776|"Part A planned doses cohort 1 to cohort 3 0.001 mg/kg, 0.01 mg/kg and 0.1 mg/kg.
~Part B planned doses cohort 4 to cohort 7 0.1 mg/kg, 1mg/kg, 3mg/kg and 10 mg/kg"
12017654|NCT00459550|Drug|Placebo to match GSK933776|Part A first 2 cohorts 5 patients per cohort 2 placebo and 3 active third cohort part A 2 placebo 6 active. Part B 8 patients per cohort 2 placebo 6 active.
12017655|NCT00459537|Drug|terbinafine hydrogen chloride|10 % terbinafine hydrogen chloride (HCL)
12017656|NCT00459537|Drug|amorolfine nail lacquer|5 % amorolfine nail lacquer
12017657|NCT00459524|Behavioral|Questionnaire|Questionnaires taking about 30 minutes to complete.
12017658|NCT00459524|Behavioral|Neurocognitive Testing|Neurocognitive testing lasting 30 minutes. Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears.
12017659|NCT00459511|Procedure|Blood AM, IL-6, ACTH, Cortisol, Glucose and Insulin|
12017660|NCT00459485|Dietary Supplement|zinc sulfate|20 or 10 mg zinc per day for 3 weeks
12017661|NCT00459485|Dietary Supplement|Placebo|Daily placebo for 3 weeks
12017662|NCT00459472|Behavioral|laparoscopic training curriculum|All general surgery interns and PGY-2-5's already participate in a surgery training curriculum that includes lectures, surgery, laparoscopic training, attending surgeons evaluating performance of residents at the end of surgical procedures, written tests, and skills tests.
12017663|NCT00459459|Procedure|Fine needle aspiration of the thyroid|
12017664|NCT00459446|Drug|MS-325 Injection (Gadofosveset Trisodium)|
12017665|NCT00459433|Procedure|Biopsychosocial intervention|Psychosocial versus usual care
12017666|NCT00459420|Drug|Caffeine 100-200 mg BID|Caffeine 100 mg BID for three weeks, then 200 mg BID for three weeks, then 100 mg BID for 1 week, then placebo
12017667|NCT00459420|Drug|placebo|placebo
12017668|NCT00459407|Dietary Supplement|defined green tea catechin extract|Given orally
12017669|NCT00459407|Drug|placebo|Given orally
12017670|NCT00459407|Other|immunohistochemistry staining method|Correlative studies
12017671|NCT00459407|Other|immunoenzyme technique|Correlative studies
12017672|NCT00459407|Other|laboratory biomarker analysis|Correlative studies
12017673|NCT00459407|Procedure|biopsy|Undergo biopsy
12017674|NCT00459407|Other|mass spectrometry|Correlative studies
12017675|NCT00459407|Other|high performance liquid chromatography|Correlative studies
12017676|NCT00459381|Drug|pazopanib hydrochloride|Given orally
12017677|NCT00459381|Other|laboratory biomarker analysis|Correlative studies
12017890|NCT00457678|Drug|Lucentis|
12017891|NCT00457678|Drug|Dexamethasone|
12017678|NCT00459368|Behavioral|Feedback of patient adherence information|Patient inhaled corticosteroid adherence information is being provided to physicians at clinic sites randomized to the intervention arm. Adherence information is available via electronic prescribing software, and so is available to physicians when writing, renewing, or viewing medications. Physicians at intervention sites also receive standard training in how to interpret adherence metrics and how to intervene on poor adherence.
12017679|NCT00459368|Behavioral|Active control group|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
12017680|NCT00459355|Behavioral|Home Safety Toolkit|Health literacy-verified booklet and home safety items to promote competence to make home safety modifications.
12017681|NCT00459342|Drug|dasatinib|Given orally
12017682|NCT00459329|Behavioral|Program to Encourage Active, Rewarding Lives (PEARL)|"Eight 50-minute in-home sessions over 19 weeks with a masters-level social work counselor using Problem Solving Therapy (PST).
~PST is a skills-enhancing behavioral depression treatment based on the assumption that an accumulation of problems in living cause and maintain depressive symptoms, and through systematically identifying and addressing these problems, patients achieve decreased depressive symptoms. Counselors also help participants to increase social and physical activities and to incorporate pleasant activities into patients' lives.
~Counselors provide education and monitoring for antidepressant use, and work with the participant's physician and PEARL psychiatrist to recommend initiating or adjusting antidepressant medications. The PHQ-9 is administered at each session to track depression change.
~After 19 weeks, counselors will maintain monthly telephone calls with participants, administering the PHQ-9 and assessing PST success."
12017683|NCT00459316|Biological|Quadrivalent meningococcal conjugate vaccine|MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than three times for each participant, depending on adverse reactions.
12017684|NCT00459303|Device|aspherical intraocular lens|implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
12017685|NCT00459303|Device|spherical intraocular lens|implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
12017686|NCT00459290|Drug|mifepristone|
12017687|NCT00459277|Drug|Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)|
12017688|NCT00459264|Drug|Folic Acid|Folic acid oral solution 2.5mg/5ml daily for up to 3 years
12017689|NCT00459264|Drug|Placebo|Matching placebo for folic acid oral solution (2.5mg/5ml)
12017690|NCT00459238|Other|counseling intervention|subjects will receive telephone based counseling
12017691|NCT00459238|Other|educational intervention|subjects will received telephone based education
12017692|NCT00459225|Drug|Iron (ferrous sulfate)|The subjects in the iron treatment arm of the study will receive 3 mg/kg of oral/enteral iron solution once a day beginning at the time of discharge until the pre-Glenn screening which is the endpoint of the study. The iron will be dispensed for the subjects upon discharge from the hospital. The subjects randomized to the no iron treatment arm and the patients in Group II of the study will not receive iron upon discharge. However, they may be started on iron therapy in an intent-to-treat anemia by their primary physician in which case this will serve as the endpoint of the study for these participants.
12017693|NCT00459212|Drug|GTI-2040|Given IV
12017694|NCT00459212|Procedure|pharmacological study|Correlative study
12017695|NCT00459212|Procedure|laboratory biomarker analysis|Correlative study
12017696|NCT00459186|Drug|RAD001|Daily for two weeks
12017697|NCT00459186|Drug|Docetaxel|Infusion once per cycle
12017698|NCT00459186|Drug|Prednisone|Prednisone 5 mg by mouth twice daily
12017699|NCT00459173|Drug|rimonabant (SR141716)|
12017700|NCT00459160|Procedure|Intraoperative Hypotensive Resuscitation|Patients will have a target minimum MAP of 50 for the case
12017701|NCT00459134|Dietary Supplement|ArginMax|Given orally
12017702|NCT00459134|Dietary Supplement|Placebo|Given orally
12017703|NCT00459121|Drug|carboplatin|Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1
12017704|NCT00459121|Drug|paclitaxel|Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1.
12017705|NCT00459121|Drug|Zactima|Zactima- 100 mg orally daily, starting on day 1 of cycle 1.
12017706|NCT00459121|Procedure|neoadjuvant therapy|Neoadjuvant surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.
12017707|NCT00459108|Drug|dasatinib|Given orally
12017708|NCT00459082|Drug|Dexmedetomine|
12017709|NCT00459069|Biological|Dendritic Cell Tumor Fusion Vaccine|Vaccine administered on weeks 0, 3 and 6
12017710|NCT00459056|Drug|Carvedilol CR + Lisinopril|Participants were given Carvedilol CR + Lisinopril for three months. Oral medication. Carvedilol CR and Lisinopril combination therapy was initiated at 20 mg and 10 mg, respectively. Patients returned one week later and doses of carvedilol CR and lisinopril were increased to 40 mg and 20 mg, respectively, depending on blood pressure.
12017711|NCT00459056|Drug|Lisinopril + HCTZ|Participants were given Lisinopril + HCTZ for three months. Oral medication. Lisinopril + HCTZ combination therapy was initiated at 12.5 mg and 10 mg, respectively. Patients returned 1 week later and doses of hydrochlorothiazide and lisinopril were increased to 25 mg and 20 mg, respectively, depending on blood pressure levels.
12017712|NCT00459043|Drug|ZD6474|Taken orally once every morning
12017713|NCT00459043|Drug|Docetaxel|Given on the first day of every treatment cycle (every 3 weeks)
12017714|NCT00459030|Other|educational intervention via internet|additional cancer screening information via password protected internet site
12017715|NCT00459030|Other|educational intervention mailed|
12017716|NCT00459030|Other|No additional educational intervention|
12017717|NCT00459017|Device|Portable blood pressure wrist manometer|
12017718|NCT00459004|Drug|rimonabant (SR141716)|
12017892|NCT00457665|Drug|Nelfinavir|
12017893|NCT00457665|Drug|Efavirenz|
12017894|NCT00457652|Drug|Rosuvastatin|7 day treatment rosuvastatin 20mg
12017719|NCT00458991|Drug|Dextromethorphan and Caffeine|"All subjects received standard medical therapy with rhGH and at specified times low doses of the pharmacologic probes (e.g., caffeine and dextromethorphan) as surrogate markers to determine CYP450 activity. The only direct treatment effect measured was the biological response to rhGH."
12017720|NCT00458978|Drug|Cediranib Maleate|Given orally
12017721|NCT00458978|Other|Laboratory Biomarker Analysis|Correlative studies
12017722|NCT00458952|Drug|Ultratrace Iobenguane (MIBG) I 131|Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose
12017723|NCT00458913|Drug|bortezomib|
12017724|NCT00458913|Drug|cisplatin|
12017725|NCT00458900|Drug|IV and enteral administration of moxifloxacin|IV and enteral administration of moxifloxacin
12017726|NCT00458887|Procedure|management of therapy complications|Undergo hearing tests
12017727|NCT00458874|Behavioral|CIMT results|"Both groups will receive a weekly confidential packet of scripted materials (e.g. educational materials, class schedules, feedback from diet/exercise logs). The R-CIMT group will also receive an CIMT report which contains a copy of one of their own ultrasound scans, with a comparison normal scan. This report will also include the CIMT thickness, an interpretation that states their measurements are in the highest quartile for persons of their age and gender, and associated CVD risk. Interpreting Your CIMT Results tutorial will be included in the first weekly packet to educate subjects on the detection of atherosclerosis with carotid ultrasound. The CIMT results are withheld from the W-CIMT group until the end of their study participation along with the CIMT tutorial."
12017728|NCT00458861|Biological|BG9924|Subcutaneous administration of BG9924 given every other week for 12 weeks
12017729|NCT00458861|Other|Placebo Comparator|Subcutaneous administration of placebo given every other week for 12 weeks
12017730|NCT00458848|Drug|asparaginase|
12017731|NCT00458848|Drug|daunorubicin hydrochloride|
12017732|NCT00458848|Drug|etoposide|
12017733|NCT00458848|Drug|idarubicin|
12017734|NCT00458848|Drug|imatinib mesylate|
12017735|NCT00458848|Drug|mercaptopurine|
12017736|NCT00458848|Drug|methotrexate|
12017737|NCT00458848|Drug|methylprednisolone|
12017738|NCT00458848|Drug|mitoxantrone hydrochloride|
12017739|NCT00458848|Drug|prednisone|
12017740|NCT00458848|Drug|vincristine sulfate|
12017741|NCT00458848|Procedure|allogeneic hematopoietic stem cell transplantation|
12017742|NCT00458848|Procedure|autologous hematopoietic stem cell transplantation|
12017743|NCT00458848|Procedure|peripheral blood stem cell transplantation|
12017744|NCT00458848|Radiation|radiation therapy|
12017745|NCT00458835|Drug|Ciclesonide|
12017746|NCT00458822|Drug|bortezomib|Given IV
12017747|NCT00458822|Drug|dexamethasone|Given orally
12017748|NCT00458809|Drug|oxaliplatin|Intraperitoneal Hyperthermic Chemoperfusion with Oxaliplatin
12017749|NCT00458796|Drug|zoledronic acid|
12017750|NCT00458796|Procedure|quality-of-life assessment|
12017751|NCT00458783|Biological|Prolonged RBC storage|Transfusion with oldest available matching RBCs
12017752|NCT00458783|Biological|Short RBC storage|Transfusion with youngest available matching RBCs
12017753|NCT00458770|Procedure|position emission transaxial tomography|cerebral position emission transaxial tomography using 18Fluorodeoxyglucose
12017754|NCT00458744|Drug|talotrexin|
12017755|NCT00458744|Procedure|chemotherapy|
12017756|NCT00458731|Biological|bevacizumab|Given IV
12017757|NCT00458731|Drug|cediranib maleate|Given orally
12017758|NCT00458718|Drug|rimonabant (SR141716)|
12017759|NCT00458705|Drug|bortezomib|
12017760|NCT00458705|Drug|dexamethasone|
12017761|NCT00458705|Drug|pegylated liposomal doxorubicin hydrochloride|
12017762|NCT00458705|Drug|thalidomide|
12017763|NCT00458679|Biological|CD40 LIGAND AND IL-2-EXPRESSING TUMOR CELLS VACCINE|Patients will receive a fixed dose (2 x 10^7) of IL-2 secreting B-cells together with (2 x 10^7)hCD40L expressing B-cells. They will receive 18 deltoid injections over 52 weeks.
12017764|NCT00458653|Biological|Dendritic Cell Tumor Fusion|"Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses.
~Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT"
12017765|NCT00458614|Drug|Lansoprazole|
12017766|NCT00458601|Drug|CDX-110 with GM-CSF|Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
12017767|NCT00458601|Drug|Temozolomide|Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.
12017768|NCT00458588|Other|physiologic testing|
12017769|NCT00458588|Other|questionnaire administration|
12017770|NCT00458588|Procedure|breast imaging study|
12017771|NCT00458588|Procedure|dual x-ray absorptometry|
12017772|NCT00458588|Procedure|evaluation of cancer risk factors|
12017773|NCT00458588|Procedure|magnetic resonance imaging|
12017774|NCT00458575|Drug|CNTO 2476|Participant 1 will receive 5.6x100000; Participants 2, 3, 5, 6, and 7 will receive 6.0x10000; Participant 4 will receive 3.0x100000; and Participants 8 and 9 will receive 1.2x100000 of CNTO 2476 as a single dose of viable cells in phosphate buffered saline (PBS) in a total volume of 100 μL injected subretinally.
12017775|NCT00458549|Dietary Supplement|omega-3 fatty acids|omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
12017776|NCT00458549|Procedure|biopsy|
12017777|NCT00458536|Biological|Dendritic Cell Tumor Fusion Vaccine|3 vaccinations at three week intervals
12017778|NCT00458536|Drug|Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)|Combined with the vaccine in the remaining subjects after the first 6 are enrolled.
12017779|NCT00458523|Biological|alemtuzumab|
12017780|NCT00458523|Genetic|fluorescence in situ hybridization|
12017781|NCT00458523|Genetic|mutation analysis|
12017782|NCT00458523|Other|flow cytometry|
12017783|NCT00458510|Drug|Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)|treatment of up to 4 episodes of pain per day
12017784|NCT00458497|Device|Holofiber fabric|Subjects will be given 3 pairs of socks (subjects with foot pain only) and bedding (mattress pad)fabricated from 1.8 dernier polyethylene terephthalate (PET) fabric to which Holofiber particles have been added during fiber manufacture.
12017785|NCT00458497|Device|PET fabric|Subjects will be given 3 pairs of socks (subjects with foot pain only) and bedding (mattress pad)fabricated from 1.8 dernier polyethylene terephthalate (PET)fabric.
12017786|NCT00458484|Radiation|stereotactic radiosurgery|"Series I: Radiation will be delivered in 4 fractions.
~Series II: Radiation will be delivered in 3 fractions."
12017787|NCT00458484|Procedure|Renal Biopsy|At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
12017788|NCT00458484|Procedure|Serum Blood Markers|ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
12017789|NCT00458471|Device|Insertion of a urinary catheter coated with benign E. coli|
12017790|NCT00458458|Drug|Norethindrone Acetate (NA)|52 weeks of treatment with Norethindrone Acetate
12017791|NCT00458458|Drug|GnRH Agonist (Lupron Depot)|24 weeks of treatment with Lupron Depot then 28 weeks of treatment with Norethindrone Acetate
12017792|NCT00458445|Drug|SPD465|
12017793|NCT00458419|Drug|naloxone versus placebo|10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
12017794|NCT00458419|Drug|intravenous injection of normal saline or naloxone|Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline
12017795|NCT00458406|Device|Bi-Flex|"Bi-Flex: Subjects in this arm undergo bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
~Positive pressure used during sleep for 3 months"
12017796|NCT00458406|Device|CPAP|"CPAP: Subjects in this arm undergo standard continuous positive airway pressure (CPAP) therapy.
~Positive pressure used during sleep for 3 months."
12017797|NCT00458393|Drug|daily TDF/FTC|daily oral medication
12017798|NCT00458393|Drug|Placebo|daily oral medication
12017799|NCT00458380|Procedure|Controlled ovarian stimulation, perifollicular vascularity assessment, IVF, embryo transfer.|
12017800|NCT00458367|Drug|Open label risperidone long acting injectable|intramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg
12017801|NCT00458354|Device|Spinal Sealant|Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.
12017802|NCT00458354|Procedure|Standard Methods of Closing of the Dura|Standard methods such as the closing of the dura with stitches.
12017803|NCT00458341|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water, milk, or apple juice. Participants are to receive a total of 42 doses of ataluren during each cycle, for a total of 84 doses of ataluren in both cycles.
12017804|NCT00458328|Drug|Z-338|
12017805|NCT00458315|Drug|Cisplatin|
12017806|NCT00458315|Drug|Paclitaxel|
12017807|NCT00458315|Drug|Gemcitabine|
12017808|NCT00458315|Drug|Avastin (Bevacizumab)|
12017809|NCT00458302|Drug|darunavir (DRV, TMC114)|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
12017810|NCT00458302|Drug|darunavir (DRV, TMC114)|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
12017811|NCT00458289|Drug|Lanthanum carbonate (chewed vs. crushed)|single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
12017812|NCT00458276|Drug|tezosentan|Tezosentan (ACT-050089, Ro 61-0612) as a 1% solution in 0.9% NaCl (i.e., normal saline) for i.v. use.
12017813|NCT00458276|Drug|placebo|Placebo (i.e., normal saline) for i.v. use.
12017814|NCT00458263|Drug|Somatotropin growth hormone recombinant human|daily Sub Cutaneous injections
12017815|NCT00458250|Procedure|Haploidentical hematopoietic stem cell transplantation|
12017816|NCT00458250|Drug|Busulfan|
12017817|NCT00458250|Drug|Cyclophosphamide|
12017818|NCT00458250|Drug|CAMPATH-1H|
12017819|NCT00458250|Drug|Cyclosporin A|
12017820|NCT00458250|Drug|Methotrexate|
12017821|NCT00458237|Drug|Everolimus|Everolimus is being administered orally 7 days per week.
12017822|NCT00458237|Drug|Trastuzumab|Trastuzumab is being administered at a dose of 6 mg/kg intravenously once every 21 days.
12017823|NCT00458224|Behavioral|parental counseling|Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training
12017824|NCT00458211|Drug|ziprasidone|Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks
12017825|NCT00458198|Behavioral|Integrated behavioral therapy (BT)|Participants in the BT condition will receive twenty 60-minute sessions over 24 weeks. Sessions will focus on graduated exposure to new speaking situations as the primary agent of anxiety reduction. Behavioral procedures will include systematic desensitization, shaping, and self-modeling procedures. Although a variety of exposure exercises will be routinely conducted in-session, any behavioral assignments will take place outside of session. Behavioral exercises will be implemented, as needed, in a modular fashion. For example, exercises may focus on speaking in-session to therapist, either at school or at home with others present. The therapist will be primarily responsible for developing the exposure parameters, but collaboration of parent, teacher, child will be emphasized increasingly over time. Reinforcement for attempts to complete assignments (contingency management program) will occur throughout treatment.
12017826|NCT00458185|Drug|etanercept|
12017827|NCT00458172|Behavioral|Assessment of beliefs and attitudes|
12017828|NCT00458159|Drug|CC-11006|Doses: 10mg, 15mg, 25mg, 35mg, & 50mg, taken once daily, orally.
12017829|NCT00458146|Drug|MM-093|60mg MM-093/week as a subcutaneous injection for 3 months
12017830|NCT00458133|Behavioral|exercise|compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
12017831|NCT00458120|Biological|rDEN1delta30|Live attenuated 10^3 dose of rDEN1delta30 vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN2/4delta30(ME) vaccines.
12017832|NCT00458120|Biological|rDEN2/4delta30(ME)|Live attenuated 10^3 dose of rDEN2/4delta30(ME) vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN1delta30 vaccines.
12017835|NCT00458094|Behavioral|Physical activity intervention with peer support (PA+PS)|Participants in the PA+PS group will have three exercise sessions each week for 4 months, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions.
12017836|NCT00458094|Behavioral|Physical activity intervention without peer support (PA)|Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator.
12017837|NCT00458081|Drug|Rimonabant|20 mg once per day + slightly reduced calorie diet
12017838|NCT00458081|Drug|Placebo|placebo once per day + slightly reduced calorie diet
12017839|NCT00458068|Drug|Oral administration of ferrous sulphate|
12017840|NCT00458055|Drug|Atorvastatin; Fenofibrate; Niacin|Atorvastatin 20 mg; Fenofibrate 200 mg; Niacin 2g used sequentially for 8 weeks, after 4 weeks washout.
12017841|NCT00458042|Drug|treprostinil sodium|
12017842|NCT00458029|Behavioral|integrated program of nutrition, activity, behavior, and promotion|implemented across 5 half-year periods: winter/spring 2007, fall 2007, winter/spring 2007, fall 2008, winter/spring 2008
12017843|NCT00458016|Drug|MB07803|Daily oral administration
12017844|NCT00458016|Drug|Placebo|Daily oral administration
12017845|NCT00458003|Drug|Ephedrine|Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
12017846|NCT00458003|Drug|Phenylephrine|Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
12017847|NCT00457990|Drug|Oral administration of ferrous sulphate|
12017848|NCT00457977|Biological|Pneumovax (PPSV23)|Injection
12017849|NCT00457977|Biological|Prevnar (PCV7)|Injection
12017850|NCT00457964|Drug|RAD001|5 and 10 mg/day or 30, 50, 70mg/week
12017851|NCT00457951|Drug|Open-Label|ODSH administered open-label
12017852|NCT00457951|Drug|Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride|Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride
12017853|NCT00457951|Drug|ODSH|Randomized, Blinded, ODSH Arm
12017854|NCT00457938|Other|low-fat diet ( Still recruiting )|This study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters.
12017855|NCT00457938|Other|Diet|10 % versus 35 % fat in diet
12017856|NCT00457925|Drug|GSK221149A|
12017857|NCT00457899|Drug|Quetiapine IR (Immediate Release)|oral
12017858|NCT00457873|Drug|0.9% saline in 5% dextrose (intravenous)|
12017859|NCT00457873|Drug|0.45% saline in 5% dextrose (intravenous)|
12017860|NCT00457860|Drug|Immunotoxin therapy|
12017861|NCT00457860|Drug|CAT-8015 immunotoxin|
12017862|NCT00457860|Procedure|Biological therapy|
12017863|NCT00457834|Device|InSync III|Bi-ventricular pacing from leads in LV+RVA or LV+RVOT
12017864|NCT00457821|Drug|Ivacaftor 25 mg/75 mg|25 mg or 75 mg q12h for a total of 28 days (Part 1)
12017865|NCT00457821|Drug|Ivacaftor 75 mg/150 mg|75 mg or 150 mg q12h for a total of 28 days (Part 1)
12017866|NCT00457821|Drug|Ivacaftor 150 mg or 250 mg|150 mg or 250 mg of ivacaftor q12h for 28 days (Part 2)
12017867|NCT00457821|Drug|Placebo|Given q12h for 28 days each in Part 1 and Part 2 of the study
12017868|NCT00457808|Drug|Rapamycin, sirolimus|
12017869|NCT00457795|Drug|brimonidine 0.1% (Alphagan® P)|Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
12017870|NCT00457782|Drug|KW-2478|Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts
12017871|NCT00457769|Drug|Donepezil and self-generated memory training|Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
12017872|NCT00457769|Drug|Donepezil and experimenter-administered memory training|Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
12017873|NCT00457756|Dietary Supplement|BiosLife Complete|
12017874|NCT00457756|Dietary Supplement|Placebo|
12017875|NCT00457743|Drug|Sunitinib malate (SU011248)|SU011248
12017876|NCT00457730|Drug|Duloxetine|Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
12017877|NCT00457730|Drug|Placebo|Subjects are randomized to either Duloxetine or Placebo
12017878|NCT00457717|Drug|0.25 % atropine|
12017879|NCT00457717|Drug|0.5 % atropine|
12017880|NCT00457717|Procedure|0.25 % atropine+auricular acupoints|
12017881|NCT00457691|Drug|5 fluorouracil|400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
12017882|NCT00457691|Drug|irinotecan|180mg/m2 iv day 1 every 14 days
12017883|NCT00457691|Drug|levo- leucovorin|200mg/m2 iv; day 1 every 14 days
12017884|NCT00457691|Drug|sunitinib|37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
12017885|NCT00457691|Drug|5 fluorouracil|400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
12017886|NCT00457691|Drug|irinotecan|180mg/m2 iv day 1 every 14 days
12017887|NCT00457691|Drug|levo- leucovorin|200mg/m2 iv; day 1 every 14 days
12017888|NCT00457691|Drug|placebo|37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
12017895|NCT00457639|Drug|Cholic Acid|Capsules of active Cholic Acid or matching placebo, total dose is 15 mg/kg per day, maximum dose of 1500 mg per day, taken PO, BID.
12017896|NCT00457626|Drug|Valsartan|All patients started with dose 1 mg/kg once daily for first 2 weeks, up-titration to 2mg/kg (then to 4mg/kg) depending on MSSBP.
12017897|NCT00457613|Drug|bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)|
12017898|NCT00457600|Procedure|patient-driven health IT product|
12017899|NCT00457574|Drug|GMX1777|
12017900|NCT00457548|Behavioral|Brief Telephone Counseling for risky aclohol use|Two brief sessions (30-40 minutes) of brief counseling using a motivational interviewing approach. The counseling session are delivered by telephone and focus on the alcohol use of inuured ED patients who randomize into the treatment arm of the study. Patient who randomize into the controla rm of the study receive standard emergency department care only plus study assessments.
12017901|NCT00457522|Behavioral|Nurse/community health worker telephone intervention|
12017902|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
12017903|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
12017904|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
12017905|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
12017906|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine|0.5 mL, Intramuscular
12017907|NCT00457496|Behavioral|Cognitive, behavioral, exercise|Relaxation exercises once a day, visual feedback, exercises for neck and shoulder
12017908|NCT00457483|Drug|hydrochlorothiazide|12.5 mg once-a-day
12017909|NCT00457483|Drug|valsartan, 80 mg once-a-day|80 mg once-a-day
12017910|NCT00457470|Drug|AG-014699|
12017911|NCT00457457|Drug|Tamsulosin|Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
12017912|NCT00457457|Drug|UK-369,003|UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (>80 fold) compared to sildenafil (~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED
12017913|NCT00457444|Drug|Pollen|
12017914|NCT00457431|Procedure|Mild therapeutic hypothermia|Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals
12017915|NCT00457418|Drug|PEG-Intron|
12017916|NCT00457405|Drug|dipyridamole|dipyridamole 200mg twice daily
12017917|NCT00457392|Drug|erlotinib|plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
12017918|NCT00457392|Drug|sunitinib|Sunitinib 37.5 mg daily by oral capsules in a continuous regimen
12017919|NCT00457392|Drug|erlotinib|plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
12017920|NCT00457392|Drug|placebo|Placebo daily by oral capsules in a continuous regimen
12017921|NCT00457379|Behavioral|physical exercise|
12017922|NCT00457366|Drug|Quetiapine|Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD
12017923|NCT00457366|Drug|Haloperidol|given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary
12017924|NCT00457366|Drug|Lorazepam|given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.
12017925|NCT00457366|Drug|Cogentin|given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
12017926|NCT00457353|Drug|Bacillus Clausii|For 5 days
12017927|NCT00457353|Other|Oral rehydration therapy|For 5 days
12017928|NCT00457340|Drug|Atorvastatin 80mg|
12017929|NCT00457327|Procedure|protective ileostomy|
12017930|NCT00457314|Behavioral|Exercise|Regular exercise training
12017931|NCT00457301|Behavioral|HUI score card|Patients completed the HUI2 and HUI3 before the encounter with the clinician, the result was graphically represented in the HUI score card. Clinicians used the HUI score card as an extra tool to help them in the management of the patients
12017932|NCT00457288|Drug|TF 002|
12017933|NCT00457275|Drug|MK0653, ezetimibe / Duration of Treatment: 4 Weeks|
12017934|NCT00457262|Procedure|soy consumption|
12017935|NCT00457249|Biological|ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed|0.5 mL, IM
12017936|NCT00457249|Biological|DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed|0.5 mL, IM
12017937|NCT00457223|Procedure|Amniotic membrane transplantation using fibrin glue|After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group.
12017938|NCT00457210|Procedure|Brain Radiotherapy/Stereotactic Radiosurgery|
12017939|NCT00457197|Drug|Placebo|Inactive ingredient matching the active medication in appearance.
12017940|NCT00457197|Drug|Quetiapine|Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
12017941|NCT00457184|Procedure|Blood tests|
12017942|NCT00457171|Drug|GI-270384|
12017943|NCT00457158|Device|ALN optional filter|J1 : ALN optional filter M3 : ALN optional filter removed
12017944|NCT00457145|Drug|Ranibizumab|
12017945|NCT00457132|Device|APOS biomechanical gait system|
12017946|NCT00457119|Drug|RAD001|5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
12017947|NCT00457106|Drug|Paroxetine|
12017948|NCT00457106|Drug|Risperidone|
12017949|NCT00457093|Drug|glargine|
12017950|NCT00457093|Drug|detemir|
12017951|NCT00457080|Device|Alaris ETCO2 monitor - cont. resp. rate, & apnea events|
12017952|NCT00457067|Drug|Ranibizumab|
12017953|NCT00457054|Drug|Lithium|starting dose 600 mg increase as tolerated
12017954|NCT00457015|Drug|ecallantide|dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
12017955|NCT00457015|Drug|Phosphate Buffer Saline (PBS), pH 7.0|given as three 1mL subcutaneous injections.
12017956|NCT00457002|Drug|Apixaban|"Apixaban: Twice daily, 30 days
~Placebo: Once daily, 6-14 days"
12017957|NCT00457002|Drug|Enoxaparin|"Enoxaparin: Once daily, 6-14 days
~Placebo: Twice daily, 30 days"
12017958|NCT00456989|Drug|Taxotere|Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.
12017959|NCT00456989|Drug|Doxil|Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
12017960|NCT00456976|Drug|Selegiline|
12017961|NCT00456963|Behavioral|Diet|total fat < 5%, saturated fat < 10%, vegetables, fruit
12017962|NCT00456963|Behavioral|Moderate exercise|30 min at least 5 times/week
12017963|NCT00456963|Drug|enalapril tablets|one Enalapril 10mg tablet once daily for four weeks. Subsequentely one Enalapril 20mg tablet once daily until the end of the randomized treatment phase
12017964|NCT00456963|Drug|placebo tablets|one Enalapril placebo tablet and one Losartan placebo tablet once daily until study end.
12017965|NCT00456963|Drug|Losartan Tablets|one Losartan 50mg tablet once daily for four weeks. Subsequentely one Losartan 100mg tablet once daily until the end of the randomized treatment phase.
12017966|NCT00456937|Drug|Escitalopram|
12017967|NCT00456924|Drug|VA2914|
12017968|NCT00456911|Behavioral|Fat and carbohydrate controlled diet|
12017969|NCT00456898|Drug|desvenlafaxine sustained release (DVS SR)|
12017970|NCT00456898|Drug|Paroxetine|
12017971|NCT00456898|Drug|Codeine|
12017972|NCT00456885|Drug|exenatide|5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
12017973|NCT00456885|Drug|Placebo|Twice daily injection of placebo
12017974|NCT00456872|Drug|lidocaine|
12017975|NCT00456859|Drug|Kremezin|
12017976|NCT00456846|Drug|ABI-007|100 mg/m^2 ABI-007 weekly for 3 weeks followed by 1 week rest
12017977|NCT00456833|Drug|RAD001|
12017978|NCT00456833|Drug|erlotinib|
12017979|NCT00456820|Drug|Wellbutrin XL|
12017980|NCT00456807|Biological|Placebo|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12017981|NCT00456807|Biological|Cervarix TM|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12017982|NCT00456794|Drug|Istradefylline (KW-6002)|
12017983|NCT00456781|Device|Augmentation|Rotator Cuff Repair plus Graft Jacket
12017984|NCT00456781|Procedure|Rotator Cuff Repair without augmentation|Rotator Cuff Repair without augmentation
12017985|NCT00456755|Drug|Shi-Bi-Lin|4 weeks of treatment, dose of 1 g (two capsules), twice daily
12017986|NCT00456755|Other|Placebo|4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
12017987|NCT00456729|Drug|Metronidazole|
12017988|NCT00456729|Procedure|Blood tests|
12017989|NCT00456716|Drug|sorafenib|400mg po bid
12017990|NCT00456703|Other|intraoperative fluid management|fluid restriction
12017991|NCT00456703|Other|fluid restriction|restriction of fluids
12017992|NCT00456690|Other|Nutritional recommendations|Nutritional status assessment including complete endocrine and lipid laboratory profile and after one year of nutritional follow up a secondary assessment will be done
12017993|NCT00456677|Drug|minocycline|addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
12017994|NCT00456677|Drug|Placebos|Addition of oral placebo capsule in addition to standard of care regimen
12017995|NCT00456664|Genetic|IE gene|
12017996|NCT00456651|Device|CPAP (Continuous Positive Airway Pressure)|
12017997|NCT00456638|Drug|Depodur|Depodur vs. traditional management
12017998|NCT00456625|Biological|Engerix™-B|Intramuscular injection, 1 dose
12017999|NCT00456612|Procedure|CyberKnife|Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
12018000|NCT00456599|Drug|gemcitabine|Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.
12018001|NCT00456599|Drug|oxaliplatin|Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.
12018002|NCT00456599|Procedure|Radiation|The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
12018003|NCT00456586|Drug|KW-6002 (istradefylline)|
12018004|NCT00456573|Procedure|tonsillectomy|medically indicated tonsillectomy in subjects with and without OAS
12018005|NCT00456560|Drug|AV650|
12018006|NCT00456560|Drug|Fluvoxamine|
12018007|NCT00456560|Drug|Paroxetine|
12018008|NCT00456547|Procedure|Blood Draw|Blood was obtained for coagulation studies at 2 hours following hysterectomy or cesarean delivery.
12018009|NCT00456521|Drug|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day|
12018010|NCT00456521|Drug|Placebo|
12018011|NCT00456521|Behavioral|Intensive group lifestyle modification counseling|
12018012|NCT00456508|Drug|ecallantide|solution for SC injection, one 30 mg dose per HAE attack
12018013|NCT00456495|Drug|ranibizumab|Subconjunctival injection of drug every 2 to 4 weeks
12018014|NCT00456482|Drug|Fluocinolone Acetonide 0.59mg|Fluocinolone Acetonide Intravitreal Implant 0.59 mg
12018015|NCT00456482|Drug|Fluocinolone Acetonide 2.1mg|Fluocinolone Acetonide Intravitreal Implant 2.1 mg
12018016|NCT00456443|Procedure|Historical records|
12018017|NCT00456430|Drug|Escitalopram|10 mg a day of escitalopram by mouth per day for 4 weeks. Dose may be increased to 20 mg a day after the 4th week depending on tolerance and treatment response.
12018018|NCT00456417|Drug|123-I MNI-187 Injection and Imaging Procedures|
12018019|NCT00456404|Drug|peppermint water|
12018020|NCT00456391|Procedure|Medical history|
12018021|NCT00456391|Procedure|Brain CT scan|
12018022|NCT00456378|Device|DIAM™ Spinal Stabilization System|Surgical procedure with implantation of the Investigational device
12018023|NCT00456378|Procedure|Conservative care|Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.
12018024|NCT00456365|Drug|pravastatin|Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
12018026|NCT00456352|Procedure|duodenal exclusion|
12018027|NCT00456339|Drug|Prednisolone and amoxicillin/clavulanate|Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days
12018028|NCT00456313|Drug|FLIXOTIDE and SERETIDE|comparator
12018029|NCT00456300|Drug|Exenatide|In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
12018030|NCT00456300|Drug|Insulin|Each subject received a baseline study with insulin alone
12018031|NCT00456287|Device|CPAP (Continuous Positive Airway Pressure)|
12018032|NCT00456274|Procedure|Frequent baseline blood sampling|3 ml of blood sampled every 10 minutes for a total of 8-12 hours
12018033|NCT00456261|Drug|Pemetrexed|pemetrexed 500 mg/m2
12018034|NCT00456261|Drug|Gemcitabine|gemcitabine 1500 mg/m2
12018035|NCT00456261|Drug|Bevacizumab|bevacizumab 10mg/kg bevacizumab 15mg/kg
12018036|NCT00456261|Drug|Carboplatin|carboplatin AUC=5
12018037|NCT00456248|Drug|Infergen and ribavirin|Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks
12018038|NCT00456235|Drug|Mycophénolate Mofétil|
12018039|NCT00456235|Drug|Ciclosporine A|
12018040|NCT00456235|Drug|Tacrolimus|
12018041|NCT00456222|Behavioral|Disrupting or changing the timing or the duration of sleep|Disrupting or changing the timing or the duration of sleep
12018042|NCT00456183|Biological|MVA 85A|
12018043|NCT00456170|Procedure|Performing Vaginal hysterectomy with Harmonic Scalpel|
12018044|NCT00456157|Drug|Intra-articular Injection of OP-1 to affected knee|
12018045|NCT00456144|Drug|Gonadotropin Releasing Hormone Agonist Therapy|Given either for 24 months and 6 months
12018046|NCT00456131|Behavioral|Healthy Eating Behaviors Training|The intervention group (other group is a control without any intervention) involves 6 one-hour group sessions teaching healthy eating habits and weight gain prevention tools.
12018047|NCT00456105|Behavioral|Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician|See Detailed Description.
12018048|NCT00456105|Behavioral|Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team|See detailed description.
12018049|NCT00456105|Behavioral|Subjects without diabetes will have their blood glucose levels monitored while in the hospital|See detailed description.
12018050|NCT00456092|Drug|Apremilast|Capsules for oral administration
12018051|NCT00456092|Drug|Placebo|Capsules for oral administration
12018052|NCT00456066|Device|Export Aspiration System|Patients scheduled for emergency angioplasty
12018053|NCT00456053|Drug|FG2216|
12018054|NCT00456027|Drug|rhGAD65 formulated in Alhydrogel® (Diamyd®)|20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
12018055|NCT00456014|Drug|Escitalopram|Escitalopram will be administered at a dose of 10 mg daily for 4 weeks. If participants have not achieved response (greater than 50 % improvement in Hamilton Depression Rating Scale) by 4 weeks, the dose will be increased to 20 mg. Remission status is determined after an 8-week trial.
12018056|NCT00456014|Drug|Desipramine|Subsequent to escitalopram trial, non-remitters will be offered pharmacotherapy with desipramine. Desipramine will be initiated at a dose of 50 mg and titrated according to a treatment manual, with monitoring of therapeutic blood levels. Remission status is determined after an 8-week trial.
12018057|NCT00455975|Drug|Bevacizumab|Bevacizumab
12018058|NCT00455962|Drug|Estradiol steroid infusion|Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
12018059|NCT00455962|Drug|Progesterone steroid infusion|Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr
12018060|NCT00455936|Drug|Gefitinib|gefitinib 250mg tablet/ QD daily until Progression
12018061|NCT00455936|Procedure|chemotherapy|gemcitabine(1250mg/m2 iv on D1 & 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles
12018062|NCT00455923|Drug|Seretide|Seretide
12018063|NCT00455923|Drug|Flixotide|Flixotide
12018064|NCT00455910|Drug|Thalidomide|
12018065|NCT00455897|Drug|GM-CSF|Given 11 days before day 1 of cycle 1 for 10 days
12018066|NCT00455897|Drug|CHOP|Administered as part of standard care
12018067|NCT00455897|Drug|Rituximab|Administered as part of standard treatment
12018068|NCT00455871|Drug|reduced fluence photodynamic therapy with Visudyne|reduced fluence photodynamic therapy with visudyne
12018069|NCT00455871|Drug|Lucentis|Lucentis intravitreal injection
12018070|NCT00455858|Drug|insulin detemir|Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
12018071|NCT00455845|Device|Levonorgestrel IUD|levonorgestrel IUD
12018072|NCT00455832|Procedure|peginterferon alpha and ribavirin|sperm collection
12018073|NCT00455819|Procedure|home treatment|
12018074|NCT00455806|Drug|esomeprazole|
12018075|NCT00455806|Drug|moxifloxacin|
12018076|NCT00455806|Drug|amoxicillin|
12018077|NCT00455780|Behavioral|Weight Loss Phase|Weight loss using CBT and meal replacements
12018078|NCT00455780|Behavioral|Continued CBT|Using CBT during weight loss maintenance
12018079|NCT00455780|Behavioral|reduced energy density education|Additional nutritional learning
12018080|NCT00455780|Behavioral|continued use of meal replacements|continued use of meal replacements during weight loss maintenance
12018081|NCT00455767|Drug|EPI-hNE4|I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days
12018082|NCT00455767|Drug|Placebo|Placebo
12018083|NCT00455754|Drug|Esomeprazole|
12018084|NCT00455741|Drug|Estradiol infusion|Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr.
12018085|NCT00455741|Drug|Progesterone infusion|Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study.
12018086|NCT00455715|Drug|Sildenafil|1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit.
12018087|NCT00455702|Drug|d-cycloserine|50mg dose d-cycloserine v placebo
12018088|NCT00455689|Drug|Leuprolide acetate|"Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection
~Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
12018089|NCT00455676|Procedure|Chevron osteotomy versus Scarf osteotomy|
12018090|NCT00455663|Behavioral|Cognitive Adaptation Training|Environmental supports for all independent living skills
12018091|NCT00455663|Behavioral|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
12018092|NCT00455663|Other|Treatment as usual|Medication follow-up and limited case management provided by local community mental health authority
12018093|NCT00455650|Drug|Mecamylamine|A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
12018094|NCT00455650|Drug|Varenicline|A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
12018095|NCT00455650|Drug|Placebo|The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
12018096|NCT00455637|Biological|Botulinum toxin type A|
12018097|NCT00455624|Drug|Androgen deprivation therapy|According to standard medical care
12018098|NCT00455611|Device|CPAP (Continuous Positive Airway Pressure)|
12018099|NCT00455598|Drug|ISIS 113715|doses of 100 and 200 mg per week
12018100|NCT00455585|Drug|nevirapine, stavudine, lamivudine|
12018101|NCT00455572|Biological|Immunotherapeutic GSK1572932A|Intramuscular injection, 8 doses
12018102|NCT00455572|Drug|Cisplatin (CDDP)|Four cycles with doses based on patient's body surface area, intravenous administration
12018103|NCT00455572|Drug|Vinorelbine|Four cycles with doses based on patient's body surface area , intravenous administration
12018104|NCT00455572|Procedure|Radiotherapy|Regimen will be based upon the site's own standard procedures
12018105|NCT00455559|Drug|Perifosine|
12018106|NCT00455559|Drug|Imatinib Mesylate|
12018107|NCT00455546|Drug|A-002|
12018108|NCT00455533|Drug|Ixabepilone|Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks
12018109|NCT00455533|Drug|Paclitaxel|Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks
12018110|NCT00455533|Drug|Cyclophosphamide|Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks
12018111|NCT00455533|Drug|Doxorubicin|Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks
12018112|NCT00455520|Drug|CG5503|100, 150, 200, 250 mg twice daily given for up to 15 weeks
12018113|NCT00455520|Drug|placebo|matching placebo twice daily for 12 weeks
12018114|NCT00455507|Drug|Istradefylline|Two 10 mg KW-6002 tablets orally once daily for 12 weeks
12018115|NCT00455507|Drug|Istradefylline|Two 20 mg tablets orally once a day for 12 weeks
12018116|NCT00455507|Drug|Placebo|Two placebo tablets orally once daily for 12 weeks
12018117|NCT00455494|Drug|AQ-13|
12018118|NCT00455468|Procedure|Day-care treatment vs. hospital care|
12018119|NCT00455455|Drug|Optifree RepleniSH Multipurpose Disinfecting Solution|lens care system
12018120|NCT00455455|Drug|ReNu Multiplus Multipurpose Solution|lens care system
12018121|NCT00455442|Drug|Mifepristone|
12018122|NCT00455429|Drug|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily or 250 mg orally twice daily for 6 weeks.
12018123|NCT00455429|Drug|JNJ-26113100 (50 mg) once daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
12018124|NCT00455429|Drug|JNJ-26113100 (100 mg) once daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
12018125|NCT00455429|Drug|JNJ-26113100 (100 mg) twice daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
12018126|NCT00455429|Drug|JNJ-26113100 (250 mg) twice daily|JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.
12018127|NCT00455416|Drug|Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))|1000mgx5 daily
12018128|NCT00455416|Drug|Selenium (L-Selenomethionine),|100mcgx2 daily
12018129|NCT00455416|Drug|Garlic extract (Allicin)|6 garlic pearls daily
12018130|NCT00455416|Drug|Pomegranate juice (ellagic acid)|Pomegranate juice 100%, 660ml /495 ml every second day.
12018131|NCT00455416|Drug|Grape juice (resveratrol, quercetin)|Merlot grape juice 100%, 660ml /495 ml every second day
12018132|NCT00455416|Drug|Green Tea (Epigallocathechin gallate)|Green Tea. 2 cups daily
12018133|NCT00455403|Drug|Chloroquine|One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24
12018134|NCT00455403|Drug|Placebo Comparator|Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
12018135|NCT00455390|Procedure|Post-immediate Psychotherapeutic Intervention|
12018136|NCT00455364|Drug|Voriconazole|
12018137|NCT00455351|Drug|Vorinostat|Increasing dosing, phase I
12018138|NCT00455338|Behavioral|Meal Composition|
12018139|NCT00455325|Drug|Placebo Comparator Limb 1|1 chloroquine placebo tablet for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
12018140|NCT00455325|Drug|Chloroquine|80mg chloroquine or placebo tablet weekly for Weeks 1-3;euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
12018141|NCT00455325|Drug|Chloroquine|80mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
12018142|NCT00455325|Drug|Chloroquine|250mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
12018143|NCT00455312|Drug|Campath 1H|10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
12018144|NCT00455312|Drug|Cyclophosphamide|7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
12018145|NCT00455312|Drug|Fludarabine|6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
12018146|NCT00455312|Procedure|Total Body Irradiation|1 day before the transplant one dose (200 cGy) of total body irradiation is given
12018147|NCT00455312|Procedure|Stem Cell Transplantation|Infusion of stem cells on Day 0.
12018148|NCT00455312|Drug|antithymocyte globulin|ATG (rabbit) 3 mg/kg for 3 days.
12018149|NCT00455312|Drug|Methylprednisolone|2mg/kg IV is given before each dose of antithymocyte globulin (ATG).
12018150|NCT00455299|Procedure|Laparoscopic ventral hernia repair|
12018151|NCT00455286|Drug|Methotrexate|
12018152|NCT00455286|Drug|Methylprednisolone|
12018153|NCT00455286|Drug|Temozolomide|
12018154|NCT00455260|Drug|hGH-ViaDerm™ System (hGH or somatropin)|transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day)
12018155|NCT00455260|Device|hGH-ViaDerm™ System|"The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin).
~The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system."
12018156|NCT00455247|Drug|Glutamine|
12018157|NCT00455234|Drug|Intramuscular Olanzepine 10 mg|
12018158|NCT00455234|Drug|Intramuscular Haloperidol 5-10 mg + Promethazine 25-50 mg|
12018159|NCT00455221|Biological|Bcr-abl multipeptide vaccine|The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial
12018160|NCT00455221|Genetic|Cytokine gene adjuvant|Cytokine gene adjuvant
12018161|NCT00455208|Drug|Cura-100|
12018162|NCT00455195|Biological|alglucosidase alfa|IV infusion of 20 mg/kg; every other week (qow)
12018163|NCT00455182|Procedure|Acupuncture|Standard medical care plus a single true acupuncture treatment.The needles are strategically inserted into the scalp, trunk, arms or legs (not near the surgical site) and manipulated. The needles are withdrawn between 5 minutes and 30 minutes after insertion.
12018164|NCT00455182|Procedure|Sham Acupuncture|Standard medical care plus sham acupuncture. A single treatment, using a maximum of 9 sham needles, which adhere to the skin but do not penetrate it. The sham needles are strategically placed on the scalp, trunk, arms or legs (not near the surgical site)
12018165|NCT00455182|Procedure|Standard medical care|Standard medical care at Woodwinds Hospital includes guided imagery, essential oils and massage.
12018166|NCT00455169|Biological|Trivalent Inactivated Influenza Vaccine|Influenza vaccine
12018167|NCT00455156|Drug|150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)|150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
12018168|NCT00455143|Drug|Precedex (Dexmedetomidine)|Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.
12018169|NCT00455143|Drug|Placebo|Matching placebo given prior to surgery and continued for 24 hours postoperatively
12018170|NCT00455130|Drug|Inhaled mannitol|
12018171|NCT00455117|Drug|Intravenous Parecoxib ('Dynastat' Pfizer)|parecoxib or placebo
12018172|NCT00455104|Other|No intervention|This is an observational, voluntary registry.
12018173|NCT00455091|Drug|Adefovir Dipivoxil and Lamivudine|Adefovir Dipivoxil 10mg/day x 36 months,Lamivudine 100 mg/day x 18 months#, when HBV DNA =/> 105 copies/mL and ALT > 2.0 x UNL
12018174|NCT00455078|Procedure|esophagogastroduodenoscopy|EGD will be done pretransplant then again before 18mos post transplant.
12018175|NCT00455078|Other|Standard GER questionnaire (RDQ)|RDQ questionnaire will be done pretransplant then again before 18mos post transplant.
12018176|NCT00455078|Procedure|Scintigraphic evaluation of solid gastric emptying|Scintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant.
12018177|NCT00455078|Procedure|Twenty-four hour ambulatory pH testing|Twenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant.
12018178|NCT00455078|Procedure|Esophageal manometry testing|Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.
12018179|NCT00455065|Behavioral|Whole Grain Foods|
12018180|NCT00455052|Drug|XMT-1001|XMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD.
12018181|NCT00455039|Drug|GW572016|Dose: 1500 mg daily
12018182|NCT00455026|Drug|remifentanil|target effect site concentration during induction
12018183|NCT00455013|Drug|Thymoglobulin|Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours
12018184|NCT00455013|Drug|Belatacept|Belatacept arms will receive i.v. belatacept (10 mg/kg) on Days 1 and 5, and then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, and 12), and then every 4 weeks through Month 6 (Weeks 16, 20, and 24). After 6 months, subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial
12018185|NCT00455013|Drug|Sirolimus|Sirolimus will be initiated at 5 mg/day on Day 1 (day of transplant) and continued through Day 2. The dosing will be adjusted subsequently to keep pre-dose (C0) levels at 7 - 12 ng/mL for the first 6 months, followed by 5 - 10 ng/mL thereafter
12018186|NCT00455013|Drug|Tacrolimus|The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally up to and including week 52. Post week 52 subjects assigned to the tacrolimus arm will receive tacrolimus orally in accordance with local practice and the package insert until completion of the trial
12018187|NCT00455013|Drug|Mycophenolate Mofetil (MMF)|Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial
12018188|NCT00455000|Biological|PF-04360365|Monoclonal antibody
12018189|NCT00455000|Drug|Placebo|Placebo
12018190|NCT00454987|Biological|Menitorix|Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.
12018191|NCT00454987|Biological|Infanrix IPV|Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
12018192|NCT00454974|Device|Wearable artificial kidney|
12018193|NCT00454961|Drug|artemether-lumefantrine|
12018194|NCT00454948|Behavioral|Home-based nutrition sessions and play group exercise|
12018195|NCT00454948|Behavioral|Group-based nutrition sessions and mail-out activities|
12018196|NCT00454922|Behavioral|standard of care|no intervention
12018197|NCT00454922|Other|education|meet with trained glaucoma educator 6 times over life of study
12018198|NCT00454909|Biological|Meningococcal vaccine 134612|Single dose intramuscular injection.
12018199|NCT00454909|Biological|Menactra®|Single dose intramuscular injection.
12018200|NCT00454896|Drug|VESIcare®|Oral
12018201|NCT00454896|Drug|placebo|Oral
12018202|NCT00454883|Drug|ziprasidone|Ziprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
12018203|NCT00454870|Drug|MEM 3454|
12018204|NCT00454857|Other|Retrospective Chart Review|Retrospective chart review for up to 36 months of enrollment date.
12018205|NCT00454857|Other|Patient-reported Outcome Questionnaires|Quality of lige questionnaires as well as treatment satisfaction questionnaires are required monthly. Includes QOL, ITP-PAQ (immune thrombocytopenic purpura - patient assessment questionnaire), EQ-5D, and TSQM (Treatment Satisfaction Questionnaire for Medication).
12018206|NCT00454857|Other|Physician Survey|Physician characteristics to be collected include demographics, years of practice, medical specialty or primary treating physician, and the referral process.
12018207|NCT00454831|Device|HEP-40 chitosan|Enzymatically Hydrolyzed Polychitosamine-40 kDa
12018208|NCT00454818|Genetic|MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)|MYDICAR administered by antegrade epicardial coronary artery infusion
12018209|NCT00454818|Procedure|Placebo Infusion|Saline; epicardial coronary artery infusion
12018210|NCT00454818|Genetic|MYDICAR Phase 2 (Placebo-controlled, Randomized Study)|MYDICAR administered by antegrade epicardial coronary artery infusion
12018211|NCT00454805|Drug|AZD2171|Oral tablet
12018212|NCT00454805|Drug|Fulvestrant|intramuscular injection
12018213|NCT00454792|Other|Exercise|Back exercise: At home every day. In groups once a week. Duration 10 weeks.
12018214|NCT00454792|Other|Restitution|Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.
12018215|NCT00454779|Drug|Cisplatin|chemotherapy arm
12018216|NCT00454779|Drug|Panitumumab|experimental arm
12018217|NCT00454779|Drug|Docetaxel|chemotherapy arm
12018218|NCT00454779|Drug|Cisplatin|experimental arm
12018219|NCT00454779|Drug|Docetaxel|experimental arm
12018220|NCT00454766|Behavioral|Questionnaire|Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.
12018221|NCT00454753|Drug|Dasatinib|"tablet, Oral, 140mg/day, BID, until;
~the time of reimbursement in Korea
~the application for marketing authorization is withdrawn
~the application for marketing authorization is denied"
12018222|NCT00454740|Drug|solifenacin succinate|Oral
12018223|NCT00454714|Drug|single dose Sildenafil|Application of a single dose Sildenafil
12018224|NCT00454714|Drug|Single dose placebo|Application of a single dose placebo
12018225|NCT00454701|Drug|Alefacept exposure|Observational
12018226|NCT00454688|Drug|Asimadoline|Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks
12018227|NCT00454688|Drug|Placebo|Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
12018228|NCT00454662|Drug|olmesartan medoxomil / amlodipine or azelnidipine|AT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine
12018229|NCT00454662|Drug|olmesartan medoxomil / low dose thiazide type drug|AT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug
12018272|NCT00454480|Drug|gemtuzumab ozogamicin|
12018273|NCT00454480|Drug|melphalan|
12018274|NCT00454480|Drug|tipifarnib|
12018275|NCT00454480|Genetic|DNA methylation analysis|
12018276|NCT00454480|Genetic|cytogenetic analysis|
12018277|NCT00454480|Genetic|gene expression analysis|
12018278|NCT00454480|Genetic|mutation analysis|
12018230|NCT00454649|Drug|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
12018231|NCT00454649|Drug|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
12018232|NCT00454649|Drug|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
12018233|NCT00454649|Drug|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
12018234|NCT00454649|Drug|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
12018235|NCT00454649|Drug|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
12018236|NCT00454649|Drug|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
12018237|NCT00454649|Drug|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
12018238|NCT00454649|Drug|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
12018239|NCT00454649|Drug|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
12018240|NCT00454636|Drug|Cisplatin|80 mg/m2/day, intravenous (IV), every 3 weeks
12018241|NCT00454636|Drug|Capecitabine|1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
12018242|NCT00454636|Drug|Epirubicin|50 mg/m2/day, IV, every 3 weeks
12018243|NCT00454636|Drug|Cisplatin|60 mg/m2/day, IV, every 3 weeks
12018244|NCT00454636|Drug|Capecitabine|625 mg/m2, oral, twice daily per 3-week cycle
12018245|NCT00454636|Drug|Oxaliplatin|130 mg/m2/day, IV, every 3 weeks
12018246|NCT00454636|Drug|Docetaxel|60 mg/m2/day, IV, every 3 weeks
12018247|NCT00454636|Drug|Capecitabine|825 mg/m2, oral, twice daily for 2 weeks
12018248|NCT00454623|Behavioral|drawing serum adiponectin level|
12018249|NCT00454610|Behavioral|FLOW|
12018250|NCT00454610|Behavioral|SelfHelp|
12018251|NCT00454597|Procedure|omentectomy|surgery omentectomy
12018252|NCT00454584|Drug|CNTO 1275 45 mg|Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous
12018253|NCT00454584|Drug|CNTO 1275 90 mg|Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous
12018254|NCT00454584|Drug|Etanercept 50 mg|Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous
12018255|NCT00454571|Drug|pazopanib hydrochloride|Given PO
12018256|NCT00454571|Drug|leuprolide acetate|
12018257|NCT00454571|Drug|goserelin acetate|
12018258|NCT00454558|Drug|Riociguat (Adempas, BAY63-2521)|Biweekly uptitration of BAY63-2521 (Oral sGC Stimulator) starting from 1.0 mg TID up to 2.5 mg TID in steps of +0.5 mg according to safety and tolerability.
12018259|NCT00454545|Drug|Atorvastatin|
12018260|NCT00454532|Drug|BZL101|Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.
12018261|NCT00454519|Procedure|cytoreductive surgery|the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
12018262|NCT00454519|Procedure|intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin|Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.
12018263|NCT00454493|Drug|Omacor (omega-3-acid ethyl esters)|
12018264|NCT00454480|Biological|alemtuzumab|
12018265|NCT00454480|Drug|arsenic trioxide|
12018266|NCT00454480|Drug|azacitidine|
12018267|NCT00454480|Drug|busulfan|
12018268|NCT00454480|Drug|clofarabine|
12018269|NCT00454480|Drug|cytarabine|
12018270|NCT00454480|Drug|daunorubicin hydrochloride|
12018271|NCT00454480|Drug|fludarabine phosphate|
12018279|NCT00454480|Other|diagnostic laboratory biomarker analysis|
12018280|NCT00454480|Other|immunologic technique|
12018281|NCT00454480|Procedure|allogeneic hematopoietic stem cell transplantation|
12018282|NCT00454480|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
12018283|NCT00454467|Procedure|Baseline Questionnaire|Patients will fill out a baseline questionnaire prior to surgery.
12018284|NCT00454467|Procedure|Operative Data|Type of prosthesis and other operative data will be uploaded into our database.
12018285|NCT00454467|Procedure|Intra-operative data will be collected post-operatively|Research assistants will post-operatively collect data from patient charts.
12018286|NCT00454467|Procedure|In-hospital post-operative data will be collected|Research assistants will collect information about hospital stay from patient charts.
12018287|NCT00454467|Procedure|Satisfaction data will be extracted from Press/Ganey and on follow-up questionnaires|Follow-up questionnaires will be mailed to participants.
12018288|NCT00454467|Procedure|Cost Data|Cost Data will be collected via hospital billing databases.
12018289|NCT00454467|Procedure|Follow-up questionnaires|Participants will be mailed follow-up questionnaires.
12018290|NCT00454441|Drug|MF101|
12018291|NCT00454428|Procedure|pulsatile intra-aortic balloon pump|
12018292|NCT00454402|Drug|Alfuzosin|
12018293|NCT00454389|Device|Epi-Rad90™ Ophthalmic System|A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
12018294|NCT00454389|Drug|ranibizumab|Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
12018295|NCT00454376|Other|questionnaire administration|
12018296|NCT00454376|Procedure|quality-of-life assessment|
12018297|NCT00454363|Other|Laboratory Biomarker Analysis|Correlative studies
12018298|NCT00454363|Drug|Pazopanib Hydrochloride|Given PO
12018299|NCT00454363|Other|Pharmacological Study|Correlative studies
12018300|NCT00454350|Drug|Hectorol (doxercalciferol injection)|
12018301|NCT00454350|Drug|Zemplar (Paricalcitol injection)|
12018302|NCT00454337|Drug|FTC/TDF + EFV or LPV/R +T20|emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day) + enfuvirtide 90mg twice a day
12018303|NCT00454337|Drug|FTC/TDF + EFV or LPV/R|emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day)
12018304|NCT00454324|Drug|Carboplatin|Carboplatin will be given at a dose of target area under the concentration versus time curve in mg/mL•min (AUC)=6, on Day 1 of a 21 Day Cycle
12018305|NCT00454324|Drug|Abraxane|"Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
12018306|NCT00454311|Procedure|Biopsy of Day 3 Embryo|
12018307|NCT00454311|Procedure|· day embryo biopsy|
12018308|NCT00454298|Drug|AGG-523 (Aggrecanase Inhibitor)|
12018309|NCT00454285|Drug|Effect of Amoxicillin on bacteremia following a single-tooth extraction|Administer Amoxicillin 1 hour prior to single-tooth extraction.
12018310|NCT00454272|Drug|Teicoplanin|
12018311|NCT00454272|Drug|Vancomycin|
12018312|NCT00454259|Drug|Fentanyl/Placebo injection|Ultra low dose intravenous injection
12018313|NCT00454246|Drug|methoxy polyethylene glycol-epoetin beta|Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
12018314|NCT00454246|Drug|epoetin alfa|Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
12018315|NCT00454246|Drug|darbepoetin alfa|Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.
12018316|NCT00454233|Drug|YM543|Oral
12018317|NCT00454233|Drug|Metformin|Oral
12018318|NCT00454233|Drug|Placebo|oral
12018319|NCT00454220|Other|Placebo|33 patients to placebo + 131-I arm
12018320|NCT00454220|Drug|MRrhTSH|33 patients to 0.01 mg MRrhTSH + 131-I arm
12018321|NCT00454220|Drug|MRrhTSH|33 patients to 0.03 mg MRrhTSH + 131-I arm
12018322|NCT00454207|Drug|sildenafil citrate (UK-92,480)|sildenafil citrate (UK-92,480)
12018323|NCT00454194|Drug|pemetrexed disodium|given IV
12018324|NCT00454194|Drug|sorafenib tosylate|given orally
12018325|NCT00454181|Drug|Interferon-alpha|500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks
12018326|NCT00454181|Other|placebo|200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks
12018327|NCT00454168|Biological|PR1 leukemia peptide vaccine|Given subcutaneously
12018328|NCT00454168|Biological|sargramostim|Given subcutaneously
12018329|NCT00454168|Other|placebo|Given subcutaneously
12018330|NCT00454155|Drug|Opebacan|4 mg/kg continuous IV infusion for 30 minutes followed immediately by 6 mg/kg/day continuous IV infusion for 3 days
12018331|NCT00454142|Drug|pazopanib hydrochloride|Given PO
12018332|NCT00454142|Other|pharmacological study|Correlative studies
12018333|NCT00454142|Procedure|computed tomography|Correlative studies
12018334|NCT00454129|Procedure|cholangiography via double-balloon enteroscopy|
12018335|NCT00454129|Procedure|MR cholangiography|
12018336|NCT00454116|Drug|Vandetanib|once daily oral tablet two doses
12018337|NCT00454116|Drug|FOLFIRI|Intravenous infusion
12018338|NCT00454103|Drug|123I-Iodometomidate|
12018339|NCT00454090|Drug|AZD8330|oral tablet
12018340|NCT00454077|Procedure|radioiodine therapy after rhTSH|
12018341|NCT00454064|Behavioral|cognitive-behavioral treatment|
12018396|NCT00453570|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib|0.5 mL, IM
12018342|NCT00454051|Drug|Omalizumab|Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab.
12018343|NCT00454051|Drug|placebo|Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume.
12018344|NCT00454038|Device|HYPRO SORB F|resorbable, double layered, collagen membrane
12018345|NCT00454012|Procedure|biophysical profile|
12018346|NCT00453999|Drug|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
12018347|NCT00453999|Drug|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml)
12018348|NCT00453999|Drug|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
12018349|NCT00453986|Biological|Meningococcal vaccine GSK134612|One intramuscular dose
12018350|NCT00453986|Biological|Mencevax™ACWY|One subcutaneous dose
12018351|NCT00453986|Biological|Fluarix™|One intramuscular dose
12018352|NCT00453973|Drug|peginesatide|Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.
12018353|NCT00453973|Drug|peginesatide|Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.
12018354|NCT00453960|Dietary Supplement|Genivis|54 mg/day daily for 6 months
12018355|NCT00453960|Drug|Norethisterone Acetate|tablets 10mg/day from day 16 to 25 of menstruation
12018356|NCT00453960|Other|placebo|tablets daily for 6 months
12018357|NCT00453947|Device|CPAP and Non Invasive Ventilation|
12018358|NCT00453934|Device|h-Patch|
12018359|NCT00453921|Drug|Methylphenidate|Dosage dependent on weight
12018360|NCT00453921|Behavioral|Memory and Attention Training|Weekly Memory and Attention Training with at home practice.
12018361|NCT00453921|Other|Placebo as both treatments|Placebo capsules and Placebo Memory and Attention Training
12018362|NCT00453908|Drug|Alfuzosin|
12018363|NCT00453895|Drug|Sunitinib|50mg Sunitinib
12018364|NCT00453882|Device|flostat (TM) System|
12018365|NCT00453869|Other|liver fibrosis evaluation|Evaluation of liver fibrosis with blood test
12018366|NCT00453856|Drug|Sulfadoxine Pyrimethamine|
12018367|NCT00453843|Device|rehabilitation robotics|sequence of intervention
12018368|NCT00453843|Procedure|Movement therapy|sequence of intervention
12018369|NCT00453830|Procedure|laparoscopic sigmoid resection|a laparoscopic 5 trocars approach for left colon mobilization, sigmoid colon transsection and intracorporeal colorectal anastomosis
12018370|NCT00453817|Drug|ferucarbotran (iron-based MRI contrast agent)|islets will be incubated with ferucarbotran prior to transplantation, for imaging after transplantation
12018371|NCT00453817|Procedure|Islet transplantation|intraportal percutaneous islet transplantation
12018372|NCT00453817|Procedure|Magnetic resonance imaging|Magnetic resonance imaging of the liver before and after islet transplantation (6 days, 6 weeks, 6 months, 1 year)
12018373|NCT00453804|Drug|injectable naltrexone|
12018374|NCT00453804|Drug|oral naltrexone|
12018375|NCT00453791|Drug|GW805858|GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
12018376|NCT00453791|Drug|Placebo|Placebo MDI will be given to the subjects.
12018377|NCT00453778|Drug|FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)|
12018378|NCT00453765|Drug|montelukast|montelukast, 8 weeks, once daily, 10 milligrams
12018379|NCT00453765|Drug|placebo|placebo
12018380|NCT00453726|Procedure|Non invasive mechanical ventilation|
12018381|NCT00453700|Procedure|Trypanosoma cruzi serology|
12018382|NCT00453687|Drug|GSK233705|investigational drug
12018383|NCT00453661|Behavioral|Questionnaire|"Intervention Group:
~Cancer Screening Assessment (CSA) questionnaire 45-60 minutes annually for 4 years + Exit Questionnaire at end of study.
~Comparison Group:
~Exit Questionnaire only."
12018384|NCT00453661|Behavioral|Patient Navigator (PN)|Staff member, called patient navigator (PN), who assist with medical care and/or screenings, questionnaires.
12018385|NCT00453648|Other|White-fleshed sweet potatoes|
12018386|NCT00453648|Other|Orange-fleshed sweet potatoes (boiled)|
12018387|NCT00453648|Other|Orange-fleshed sweet potatoes (fried)|
12018388|NCT00453648|Other|WFSP and capsule of retinyl palmitate|
12018389|NCT00453635|Drug|Docetaxel|Docetaxel at the dose of 75mg/m^2 IV on day 1 every 3 weeks for 6 consecutive cycles
12018390|NCT00453635|Drug|Carboplatin|Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
12018391|NCT00453635|Drug|Herceptin|Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
12018392|NCT00453635|Drug|Vinorelbine|Vinorelbine at the dose of 60mg/m^2 per os,weekly
12018393|NCT00453622|Device|Cardiac Resynchronization Therapy-Defibrillator|Implantation of a CRT-D device
12018394|NCT00453609|Drug|long-lasting injectable naltrexone|
12018395|NCT00453570|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib|0.5 mL, IM
12018397|NCT00453570|Biological|Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed|0.5 mL, IM
12018398|NCT00453557|Drug|rhGH|
12018399|NCT00453544|Other|Enhanced Consent Procedure|This is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved
12018400|NCT00453544|Other|Routine Consent Procedure|This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)
12018401|NCT00453531|Procedure|Limb Ischemia|
12018402|NCT00453531|Drug|Acetylcholine|
12018403|NCT00453518|Device|FiberNet EPS used during SVG intervention.|The FiberNet EPS is indicated for use as a guide wire and embolic protection system to capture and remove embolic material produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts.
12018404|NCT00453505|Diagnostic Test|MRI|The MRI studies were conducted on a 3 or 7 Tesla MRI scanner located in the NIH Magnetic Resonance Imaging Research Facility (NMRF), under the guidelines of the FDA, NIH, and NMRF. Subjects lie down in the scanner in a comfortable position, and will be monitored by investigators in the control room. They are able to communicate with the investigators by intercom at the operating console at all times. If subjects ask to stop the experiment, they will be removed immediately from the scanner. During the scan, the subjects hear a rhythmic tapping sound caused by the switching of the gradient coil that is necessary to produce the image. They are required to wear Nonmagnetic earplugs. The scanning session lasts up to approximately 2 hours.
12018405|NCT00453505|Diagnostic Test|fMRI|The MRI studies were conducted on a 3 or 7 Tesla MRI scanner located in the NIH Magnetic Resonance Imaging Research Facility (NMRF), under the guidelines of the FDA, NIH, and NMRF. Subjects lie down in the scanner in a comfortable position, and will be monitored by investigators in the control room. They are able to communicate with the investigators by intercom at the operating console at all times. If subjects ask to stop the experiment, they will be removed immediately from the scanner. During the scan, the subjects hear a rhythmic tapping sound caused by the switching of the gradient coil that is necessary to produce the image. They are required to wear nonmagnetic earplugs. The scanning session lasts up to approximately 2 hours.
12018406|NCT00453505|Diagnostic Test|MRS|MRS was used to assess (1) local changes in neurotransmitter concentrations (ie.- GABA or glutamine/glutamate) due to stimulation or behavioral training, or (2) the relationship between baseline neurotransmitter concentrations and response to stimulation or behavioral intervention(s).
12018407|NCT00453505|Diagnostic Test|MEG|Magnetoencephalogra phy (MEG) records small magnetic field changes from resulting brain activity145,146. Up to four small coils will be attached to fiducial landmarks with adhesive stickers and tape to localize the subject s head position inside the scanner. Participants will be seated comfortably during recordings, with their head positioned inside a helmet containing magnetic field detectors. The recording may occur while participants are sitting quietly or performing a cognitive or motor behavioral task. Some subjects may be provided with ear- pieces if the task includes auditory stimuli and communicate with the experimenters throughout the session from within the MEG room.
12018408|NCT00453505|Diagnostic Test|EEG|EEG records the electrical activity of the brain. Small electrodes were either individually placed on the participant s scalp or multi-channel electrode arrays positioned using an electrode cap. The recording might have occurred while participants were sitting quietly or performing a cognitive or motor behavioral task. The electrodes were removed once the EEG was complete. A device consisting of computer hardware and digital signal processing software might have used to enable triggering of a stimulator system in response to a pre-defined EEG-signal. The device was used according to the Collaboration Agreement with University Neurology Hospital T(SqrRoot) bingen and Hertie Institute for Clinical Brain Research. The new device controls the timing of the stimuli based on pre-set parameters. Additional electrodes might have been placed on the scalp or limbs for offline removal of physiological artifacts from MEG or EEG data. Individual MEG or EEG sessions lasted up to 4 hours in length.
12018409|NCT00453492|Drug|risedronate sodium|
12018410|NCT00453479|Drug|GSK233705B|
12018411|NCT00453466|Behavioral|EBW group intervention to empower battered women|
12018412|NCT00453453|Drug|Nesiritide|Nesiritide given orally in the emergency department
12018413|NCT00453440|Procedure|Cheek swab & blood test|Cheek swab & blood test
12018414|NCT00453427|Drug|Alemtuzumab (Campath-1H)|The investigational drug is alemtuzumab (Campath-1H). It is a recombinant humanized monoclonal antibody directed against the CD52 antigen on most (> 95%) normal lymphocytes and T-cell and B-cell lymphomas. Alemtuzumab binds to the CD52 antigen on the cell surface, activating antibody-dependent cellular cytotoxicity, complement binding, apoptosis, cellular opsonization, and anti-tumour T-cell activity.
12018415|NCT00453414|Drug|Iloprost Inhalation Solution (Ventavis)|
12018416|NCT00453401|Drug|NB-001|
12018417|NCT00453388|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplant
12018418|NCT00453388|Drug|Cyclophosphamide|Given IV
12018419|NCT00453388|Drug|Cyclosporine|Given IV or PO
12018420|NCT00453388|Drug|Fludarabine Phosphate|Given IV
12018421|NCT00453388|Other|Laboratory Biomarker Analysis|Correlative studies
12018422|NCT00453388|Drug|Mycophenolate Mofetil|Given PO
12018423|NCT00453388|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic stem cell transplant
12018424|NCT00453388|Radiation|Total-Body Irradiation|Undergo TBI
12018425|NCT00453375|Drug|BHT-3021|Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
12018426|NCT00453375|Drug|BHT-Placebo|Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
12018427|NCT00453362|Other|2-deoxy-2-[18F]fluoro-D-glucose (FDG)|FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).
12018428|NCT00453362|Other|3'-deoxy-3'-[18F]fluorothymidine (FLT)|FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.
12018429|NCT00453362|Drug|erlotinib HCl|Tablets taken orally 150 mg/day.
12018430|NCT00453349|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
12018431|NCT00453349|Drug|Levofloxacin & Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
12018493|NCT00452907|Drug|Artesunate|oad, per os, 3 days of treatment
12018432|NCT00453336|Drug|Porfimer Sodium|Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
12018433|NCT00453336|Procedure|Photodynamic Therapy|Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
12018434|NCT00453323|Drug|Paclitaxel|paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks
12018435|NCT00453323|Drug|Capecitabine|capecitabine 900mg/m2 bid po on day 1~14, 1 weeks rest, until disease progression
12018436|NCT00453310|Drug|sunitinib malate|
12018437|NCT00453297|Drug|MF101|
12018438|NCT00453271|Drug|NB-002|
12018439|NCT00453271|Drug|Vehicle control|
12018440|NCT00453258|Other|Eye Examination|Subjects receiving eye examination
12018441|NCT00453232|Biological|bleomycin sulfate|
12018442|NCT00453232|Biological|pegfilgrastim|
12018443|NCT00453232|Drug|cisplatin|
12018444|NCT00453232|Drug|etoposide|
12018445|NCT00453219|Procedure|Screening evaluation|A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
12018446|NCT00453219|Procedure|Meal Response|The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food. Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
12018447|NCT00453219|Genetic|Blood Collection|A blood sample will be collected and used to check for genetic markers of stress vulnerability.
12018448|NCT00453219|Procedure|Functional MRI|research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions. This procedure will last about 1 hour.
12018449|NCT00453219|Procedure|Endocrine Assessment|research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours. Hormone measures of stress, reproduction, and appetite will be obtained.
12018450|NCT00453206|Procedure|allogeneic bone marrow transplantation|
12018451|NCT00453206|Procedure|allogeneic hematopoietic stem cell transplantation|
12018452|NCT00453206|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
12018453|NCT00453206|Procedure|peripheral blood stem cell transplantation|
12018454|NCT00453193|Drug|Pentostatin|4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
12018455|NCT00453193|Drug|Alemtuzumab|30 mg IV three times weekly
12018456|NCT00453180|Drug|N-acetylcysteine|Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day.
12018457|NCT00453180|Drug|Placebo|Subjects randomized to placebo arm will receive placebo pill for duration of study.
12018458|NCT00453167|Drug|Paclitaxel|Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
12018459|NCT00453167|Drug|Gemcitabine|Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
12018460|NCT00453154|Drug|Carboplatin|Given IV
12018461|NCT00453154|Drug|Cisplatin|Given IV
12018462|NCT00453154|Drug|Etoposide|Given IV
12018463|NCT00453154|Other|Laboratory Biomarker Analysis|Correlative studies
12018464|NCT00453154|Other|Placebo Administration|Given PO
12018465|NCT00453154|Drug|Sunitinib Malate|Given PO
12018466|NCT00453141|Drug|dosing of Betamethasone|
12018467|NCT00453115|Drug|Oxaliplatin|oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression
12018468|NCT00453115|Drug|Gemcitabine|gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression
12018469|NCT00453102|Drug|Rituximab|IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
12018470|NCT00453102|Drug|Ibritumomab Tiuxetan|"IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
12018471|NCT00453089|Drug|VG101|
12018472|NCT00453076|Device|Paclitaxel eluting covered metal stent and control covered metal stent|Paclitaxel eluting covered metal stent and control covered metal stent are inserted with standard ERCP technique
12018473|NCT00453063|Drug|mometasone furoate|50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning
12018474|NCT00453063|Drug|Placebo|Two sprays in each nostril once daily in the morning
12018475|NCT00453050|Drug|imiquimod|
12018476|NCT00453050|Drug|indocyanine green solution|
12018477|NCT00453050|Other|flow cytometry|
12018478|NCT00453050|Other|immunologic technique|
12018479|NCT00453050|Other|laboratory biomarker analysis|
12018480|NCT00453037|Behavioral|structured educational program|structured education and evaluation of hypertensive patients in a design similar to the DAFNE study design. Behavioural intervention follows the Dusseldorf-educational program
12018481|NCT00453037|Behavioral|participation in the educational program after 6 months|Control group consisting of patients randomly assigned to participate in the educational program 6 months later than the active group
12018482|NCT00453024|Procedure|Pericardial graft & tissue glue|
12018483|NCT00453024|Procedure|scleral flap & sutures|
12018484|NCT00453011|Device|posterior chamber intraocular lens|
12018485|NCT00453011|Device|anterior chamber intraocular lens|
12018486|NCT00452998|Procedure|Q-switched fd Nd:yag in Laser Iridotomy|
12018487|NCT00452985|Drug|Docetaxel|60-75 mg/m²
12018488|NCT00452985|Drug|Carboplatin|AUC 5
12018489|NCT00452972|Drug|Spinal Anesthesia|
12018490|NCT00452920|Drug|docetaxel|
12018491|NCT00452920|Radiation|cesium Cs 137|
12018492|NCT00452920|Radiation|radiation therapy|
12018494|NCT00452907|Drug|Artesunate + Sulfadoxine-Pyrimethamine|oad, per os
12018495|NCT00452907|Drug|arthemether + lumefantrine|bid, per os. Duration of treatment: 3 days
12018496|NCT00452894|Drug|varenicline tartrate|
12018497|NCT00452881|Drug|gemcitabine|Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles
12018498|NCT00452881|Drug|Oxaliplatin|Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
12018499|NCT00452881|Drug|Cisplatin|Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
12018500|NCT00452868|Drug|Donepezil|Donepezil 5 milligrams a day for 6 weeks
12018501|NCT00452855|Procedure|Sevoflurane-remifentanil anaesthesia|
12018502|NCT00452829|Drug|Folic Acid and inositol|Folic Acid and inositol
12018503|NCT00452829|Drug|Folic acid and placebo|Folic acid and placebo
12018504|NCT00452816|Behavioral|Workplace Solutions Consulting approach|"Consulting process includes:
~baseline measure of best practices
~gap analysis and recommendations reporting
~delivery of solution set toolkits for each practice chosen for implementation"
12018505|NCT00452816|Behavioral|Delayed intervention|Abbreviated version of the Workplace Solutions Consulting process applied in the intervention group
12018506|NCT00452803|Drug|chemotherapy|Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
12018507|NCT00452803|Drug|Concurrent chemoradiation therapy|Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
12018508|NCT00452803|Radiation|Concurrent chemoradiation therapy|Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx
12018509|NCT00452790|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose at 6, 10, 14 weeks and 12 months of age
12018510|NCT00452790|Biological|7 valent pneumococcal conjugate vaccine|1 dose at 6, 10, 14 weeks and 12 months of age
12018511|NCT00452777|Drug|BVT.115959|
12018512|NCT00452777|Drug|Placebo|
12018513|NCT00452764|Behavioral|Withdrawal of medication|
12018514|NCT00452751|Procedure|laparoscopy-assisted distal gastrectomy|
12018515|NCT00452751|Procedure|open distal gastrectomy|
12018516|NCT00452738|Behavioral|Therapy dog|
12018517|NCT00452738|Behavioral|Costumed character|
12018518|NCT00452738|Behavioral|Parents-only|
12018519|NCT00452725|Drug|MAXOMAT ®, biosynthetic growth hormone|2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration
12018520|NCT00452712|Procedure|All subjects will have their blood pressure measured in supine position (after 5 minute of rest) and after 3 minute of standing.|
12018521|NCT00452699|Drug|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
12018522|NCT00452699|Drug|Fluticasone propionate 250 mcg BID|Fluticasone propionate 250 mcg BID
12018523|NCT00452686|Biological|Boostrix|
12018524|NCT00452686|Biological|Chinese DT vaccine|
12018525|NCT00452673|Drug|Dasatinib|Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression
12018526|NCT00452673|Drug|Capecitabine|Tablets, Oral, 660 - 1250 mg/m^2 twice a day (BID). Treatment may continue until disease progression.
12018527|NCT00452660|Drug|Exjade|
12018528|NCT00452634|Drug|Irinotecan|Irinotecan 65mg/m2/iv over 90min on day 1 and 8, repeat Q 3weeks. until disease progression, unacceptable toxicity or patients' refusal.
12018529|NCT00452634|Drug|Cisplatin|Cisplatin 30mg/m2/iv over 30min on day 1 and 8, repeat Q 3weeks. until disease progression, unacceptable toxicity or patients' refusal.
12018530|NCT00452634|Drug|Simvastatin|simvastatin 40mg/QD, PO, daily, every 3 weeks
12018531|NCT00452621|Procedure|blood draw|
12018532|NCT00452608|Drug|amido pill|one pill of amido/d by mouth for 10 days
12018533|NCT00452608|Drug|atorvastatina|atorvastatina 80 mg/day by mouth for 10 days
12018534|NCT00452595|Drug|DVS-233 SR (desvenlafaxine sustained release )|
12018535|NCT00452582|Drug|Sildenafil (Viagra)|Dose escalation (one of the following): 25 mg daily for 2 weeks, 50 mg daily for 2 weeks, 75 mg daily for 2 weeks, 50 mg twice daily for two weeks, 50 mg AM and 75 mg PM for 2 weeks, 75 mg twice daily for 2 weeks, 75 mg in AM and 100 mg in PM for 2 weeks, 100 mg twice daily for 2 weeks.
12018536|NCT00452582|Other|Usual care|Physical therapy, occupational therapy, speech therapy
12018537|NCT00452569|Drug|Thalidomide|Oral thalidomide (100mg or 200mg or 400 mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 + 36 days (12 cycles of 28 +/- 3 days).
12018538|NCT00452569|Drug|Dexamethasone|High dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).
12018539|NCT00452556|Drug|Docetaxel|Weekly
12018540|NCT00452556|Drug|Leuprolide Acetate (Eligard®)|2.5 years
12018541|NCT00452556|Radiation|Intensity-Modulated Radiotherapy|Standard sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate, followed by irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)
12018542|NCT00452556|Radiation|Intensity-Modulated Radiotherapy|Experimental sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate last, irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)first
12018543|NCT00452543|Drug|acamprosate|Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.
12018544|NCT00452543|Drug|escitalopram|Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.
12018545|NCT00452543|Behavioral|Medical management|Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).
12018546|NCT00452543|Drug|Placebo|Placebo, 2 capsules PO TID, for 12 weeks
12018547|NCT00452530|Drug|Enoxaparin|40 mg, administered once daily by subcutaneous injection, for 12 days
12018548|NCT00452530|Drug|Apixaban|2.5 mg, administered twice daily as tablets, for 12 days
12018549|NCT00452530|Drug|Enoxaparin-matching placebo|Administered once daily by subcutaneous injection
12018550|NCT00452530|Drug|Apixaban-matching placebo|Oral tablet administered twice daily
12018551|NCT00452517|Procedure|Percutaneous Coronary Intervention|
12018552|NCT00452504|Drug|SRA-444|
12018553|NCT00452491|Drug|somatropin|0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years
12018554|NCT00452491|Drug|somatropin|0.2 IU/kg/day 7 days per week given continuously for 3 years
12018555|NCT00452478|Drug|Lanthanum carbonate|2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.
12018556|NCT00452465|Behavioral|ElderCare Plan|Nursing assessment and development of an appropriate care plan.
12018557|NCT00452452|Biological|13-valent Pneumococcal Conjugate Vaccine|
12018558|NCT00452439|Drug|Actonel (Risedronate)|35 mg (pill) by mouth weekly
12018559|NCT00452439|Dietary Supplement|Calcium|500 mg by mouth twice a day for a total of 24 months.
12018560|NCT00452439|Dietary Supplement|Vitamin D|400 IU by mouth twice a day for a total of 24 months.
12018561|NCT00452426|Device|Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)|propofol sedation per device instructions for use
12018562|NCT00452426|Other|benzodiazepines and opioid sedation|per site's current standard of care
12018563|NCT00452413|Drug|enzastaurin|Administered orally
12018564|NCT00452413|Drug|erlotinib|Administered orally
12018565|NCT00452400|Drug|BI 1744CL|
12018566|NCT00452387|Drug|Mitoxantrone|"Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion.
~Dose Level -2, Mitoxantrone 9mg/m2
~Dose Level -1 Mitoxantrone 12mg/m2
~Dose Level 1 Mitoxantrone 12mg/m2"
12018567|NCT00452387|Drug|Prednisone|"Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion.
~Dose Level -2, Prednisone 5mg bid
~Dose Level -1 Prednisone 5mg bid
~Dose Level 1 Prednisone 5mg bid"
12018568|NCT00452387|Drug|Sorafenib|"Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion.
~Dose Level -2, Sorafenib 400 mg QD
~Dose Level -1 Sorafenib 400 mg QD
~Dose Level 1 Sorafenib 400 mg bid"
12018569|NCT00452374|Drug|Cytarabine|1 g/m^2 given IV for two days (Days 2 and 3).
12018570|NCT00452374|Drug|Fludarabine|30 mg/m^2 given IV for two days (Days 2 and 3).
12018571|NCT00452374|Drug|Oxaliplatin|Starting dose of 17.5 mg/m^2 IV for 4 days (Days 1 through 4).
12018572|NCT00452374|Drug|Rituximab|375 mg/m^2 IV on Day 3 of the first cycle over 4-6 hours and on Day 1 on every cycle following.
12018573|NCT00452361|Drug|Sirolimus+MMF or MPS or AZA+Steroid|Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
12018574|NCT00452361|Drug|Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid|"The maintenance dose of:
~MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day
~AZA will not exceed 75 mg/day
~Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:
~continued for the entire 104-week period of randomized therapy
~subsequently discontinued
~restarted after discontinuation"
12018575|NCT00452348|Drug|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
12018576|NCT00452348|Drug|Fluticasone propionate 250 mcg BID|Fluticasone propionate 250 mcg BID
12018577|NCT00452335|Drug|Lubiprostone|12 mcg capsule once daily (QD)
12018578|NCT00452335|Drug|Lubiprostone|12 mcg capsule twice daily (BID)
12018579|NCT00452335|Drug|Lubiprostone|24 mcg capsule twice daily (BID)
12018580|NCT00452322|Drug|Testosterone Substitution by Testosterone Undecanoate i.m.|
12018581|NCT00452296|Drug|tight insulin treatment in patients hospitalized with COPD exacerbation|treatment with basal plus bolus insulin
12018582|NCT00452296|Procedure|tight glycemic control|treatment with basal and bolus insulin
12018583|NCT00452270|Drug|Xylometazoline|
12018584|NCT00452257|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease
12018585|NCT00452244|Drug|simvastatin|Simvastatin 40mg/QD po daily every 3 weeks
12018586|NCT00452244|Drug|gefitinib only|gefitinib 250mg/QD po daily every 3 weeks
12018587|NCT00452231|Drug|D-cycloserine|
12018588|NCT00452231|Behavioral|Cognitive-Behavioral Therapy|
12018589|NCT00452218|Drug|Sorafenib|200 mg daily and dose escalated to a maximum of 400 mg twice daily
12018590|NCT00452192|Drug|Telmisartan|telmisartan 80 mg daily over 2 weeks
12018591|NCT00452179|Drug|APD125|
12018592|NCT00452166|Drug|rosiglitazone|
12018593|NCT00452153|Procedure|Characterization Legionnella|"Characterisation Legionnella by polymerase chain reaction (PCR)
~Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region"
12018594|NCT00452140|Biological|ertumaxomab|10 µg, IV on day 0 followed by 100 µg every 7 days up to a maximum of 12 infusions.
12018595|NCT00452127|Drug|PRO131921|Escalating doses by IV infusion
12018596|NCT00452114|Device|In-Exsufflator Cough Assist Device|
12018597|NCT00452114|Device|Active Comparator: Flutter Valve Device|Active Comparator
12018598|NCT00452101|Drug|Aquamin F|
12018599|NCT00452088|Biological|MSP 3 Long Synthetic Peptide|Lyophilized vaccine given at 15 or 30 microgrammes
12018600|NCT00452088|Biological|Hepatitis B vaccine|Hepatitis vaccine adjuvanted in Aluminium hydroxide
12018601|NCT00452088|Biological|Hepatitis B control vaccince|Hepatitis B vaccine adjuvanted in Aluminium hydroxide
12018602|NCT00452075|Drug|erlotinib|150mg daily
12018604|NCT00452049|Procedure|parathyroidectomy|parathyroidectomy
12018605|NCT00452023|Drug|IFN-alpha2a|Starting dose 90 microgram (mcg) injection under the skin once a week
12018606|NCT00452010|Device|CEFAR PRIMO TENS Class IIA (active)|Active TENS. 4 sessions per day during 3 months.
12018607|NCT00452010|Device|CEFAR PRIMO TENS Class IIA (no active)|Placebo TENS. 4 sessions per day during 3 months.
12018608|NCT00451997|Drug|Gleevec|600 mg (capsules) by mouth once daily
12018609|NCT00451997|Drug|Ara-C|10 mg as an injection under the skin daily for 21 days of every 28 day cycle
12018610|NCT00451984|Biological|Twinrix|
12018611|NCT00451984|Biological|interleukin-2|
12018612|NCT00451971|Drug|LEFLUNOMIDE|
12018613|NCT00451958|Drug|Degarelix 80 mg / Degarelix 80 mg|
12018614|NCT00451958|Drug|Degarelix 160 mg / Degarelix 160 mg|
12018615|NCT00451958|Drug|Leuprolide 7.5 mg / Degarelix 80 mg|
12018616|NCT00451958|Drug|Leuprolide 7.5 mg / Degarelix 160 mg|
12018617|NCT00451945|Procedure|biopsy|
12018618|NCT00451945|Device|3d-ultrasound and fusion of UL and PET/CT|
12018619|NCT00451932|Drug|FK778|
12018620|NCT00451906|Drug|Platinum-based chemotherapy|As prescribed
12018621|NCT00451906|Drug|Bevacizumab [Avastin]|15 mg/kg IV on Day 1 of each 3 week cycle
12018622|NCT00451893|Procedure|Lichtenstein operation with a heavy-weight mesh|Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
12018623|NCT00451893|Procedure|Lichtenstein operation with a light-weight mesh|Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2
12018624|NCT00451880|Drug|XL281|Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
12018625|NCT00451880|Drug|famotidine|single dose, supplied as 20-mg or 40-mg tablets
12018626|NCT00451867|Drug|Mycophenolate Mofetil|
12018627|NCT00451867|Drug|Mycofenolate Mofetil (MMF)|2000 mg per day divided into 2 equal doses.
12018628|NCT00451867|Drug|Placebo|Placebo
12018629|NCT00451854|Procedure|Random, no advanced notice drug and alcohol testing|
12018630|NCT00451841|Device|RTube Exhaled Breath Condensate Collection System|Subjects breath through the device to collect exhaled breath condensate
12018631|NCT00451828|Drug|Simvastatin|40mg/day
12018632|NCT00451815|Drug|active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.|
12018633|NCT00451815|Drug|placebo|
12018634|NCT00451776|Drug|etomidate|patients who received etomidate
12018635|NCT00451776|Drug|propofol|patients who received propofol
12018636|NCT00451763|Drug|Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)|
12018637|NCT00451750|Drug|Cortisol|20 mg for 3 times
12018638|NCT00451737|Device|Isokinetic test|
12018639|NCT00451724|Drug|Intranasal ketamine|
12018640|NCT00451711|Drug|Liposomal amphotericin B|
12018641|NCT00451698|Drug|acyanotic erythropoietin|Single dose IV push
12018642|NCT00451698|Drug|acyanotic placebo|Single dose IV push
12018643|NCT00451672|Drug|bromocriptine|
12018644|NCT00451646|Drug|SMOF lipid and Intralipid|1-2 g, 5-7 days, 28 days
12018645|NCT00451633|Drug|E2007|
12018646|NCT00451620|Drug|glyburide|Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.
12018647|NCT00451620|Drug|GlucoNorm|Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.
12018648|NCT00451594|Drug|Dexamethasone|"Pulse high dose dexamethasone (Arm 1)
~Patients will receive 40 mg of oral dexamethasone daily for four consecutive days.
~Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14
~If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given.
~If the platelet count drops below 30X109/L within the first 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering.
~Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments."
12018649|NCT00451594|Drug|Prednisolone|"Conventional dose prednisone (Arm 2)
~Prednisone, 1 mg/kg is started at diagnosis. If the platelet count is more than 100X109/L, the dose should be used for 4 weeks minimally and then tapered by 10 mg/1 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/1 wk thereafter. (Ann Intern Med 1997, 126, 307-14). If the platelet count is between 30X109/L and 100X109/L, prednisone 1 mg/kg should be used for 8 weeks maximally and then tapered by 10 mg/2 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/2 wk thereafter.
~Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months"
12018650|NCT00451581|Procedure|Endoscopic papillary balloon dilation-5 minutes|
12018651|NCT00451581|Procedure|Endoscopic papillary balloon dilation-1 minute|
12018652|NCT00451568|Drug|Metformin|500 mg 2 tablets 2 times a day
12018653|NCT00451568|Drug|Desorelle|1 tablet/day in 21 days
12018654|NCT00451555|Drug|enzastaurin|1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
12018655|NCT00451555|Drug|placebo|oral, daily
12018656|NCT00451555|Drug|fulvestrant|500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression
12018657|NCT00451516|Drug|Herbal medicine (St. John's wort and Kava)|
12018658|NCT00451503|Device|Middle Ear Implant|surgery
12018659|NCT00451490|Drug|Agomelatine|
12018660|NCT00451490|Drug|Fluoxentine|
12018661|NCT00451451|Drug|BG00012|
12018662|NCT00451451|Drug|Placebo|
12018663|NCT00451451|Drug|Glatiramer Acetate|
12018664|NCT00451425|Behavioral|motivational intervention in pregnancy|Motivational program including individualized counseling on diet and physical activity
12018665|NCT00451412|Drug|Certoparin|3000 U anti XA of certoparin in 0.3 ml solution, once daily
12018666|NCT00451412|Drug|Unfractionated Heparin|solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
12018668|NCT00451399|Behavioral|lifestyle intervention|
12018669|NCT00451386|Drug|MK0826, ertapenem sodium /Duration of Treatment: 14 Days|
12018670|NCT00451386|Drug|Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days|
12018671|NCT00451373|Device|CVVH and SLED|
12018672|NCT00451373|Drug|Vancomycin|
12018673|NCT00451373|Drug|Daptomycin|
12018674|NCT00451373|Device|FX60, AV600 (dialyzer)|
12018675|NCT00451360|Drug|diacerein|
12018676|NCT00451347|Device|Quadriceps strength training|
12018677|NCT00451347|Device|Taping|
12018678|NCT00451347|Device|Home exercise|
12018679|NCT00451321|Drug|Otelixizumab|Infusion
12018680|NCT00451308|Procedure|Induction of labor with foley balloon - 60cc of saline|60 cc of fluid
12018681|NCT00451308|Procedure|Induction of labor with foley balloon with 30cc|30cc of saline in foley
12018682|NCT00451295|Drug|MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
12018683|NCT00451295|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
12018684|NCT00451282|Behavioral|stepped preventive care|2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.
12018685|NCT00451269|Device|Rapid diagnosis test for malaria|Rapid diagnosis test for malaria
12018686|NCT00451256|Drug|AVI-5126|
12018687|NCT00451230|Drug|cocaine|
12018688|NCT00451230|Drug|hydrocortisone|
12018689|NCT00451217|Drug|Sugammadex|After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
12018690|NCT00451217|Drug|Neostigmine|After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
12018691|NCT00451204|Drug|Estriol|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
12018692|NCT00451204|Drug|Placebo|Placebo capsule, once a day, treatment duration is 2 years
12018693|NCT00451204|Drug|Copaxone|Injection, once a day, all subjects
12018694|NCT00451191|Drug|botulinum toxin type A (BoNT/A)|100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
12018695|NCT00451178|Drug|enzastaurin|1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years
12018696|NCT00451178|Drug|rituximab|375 milligrams per square meter (mg/m^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
12018697|NCT00451178|Drug|cyclophosphamide|750 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles
12018698|NCT00451178|Drug|doxorubicin|50 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles
12018699|NCT00451178|Drug|vincristine|1.4 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles
12018700|NCT00451178|Drug|prednisone|100 mg, oral, Days 1-5, six 21-day cycles
12018701|NCT00451165|Procedure|laparoscopic colorectal surgery|laparoscopic colorectal surgery
12018702|NCT00451152|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.
12018703|NCT00451152|Other|Anecortave Acetate Vehicle|Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.
12018704|NCT00451139|Drug|artemether/lumefantrine|
12018705|NCT00451139|Drug|quinine|
12018706|NCT00451139|Drug|atovaquone/proguanil|
12018707|NCT00451113|Drug|Sitagliptin 100 mg|All subjects will receive a single 100 mg dose of sitagliptin and a placebo. Which they are given first is determined randomly.
12018708|NCT00451100|Drug|Sugammadex|Subjects received a bolus dose of 0.6 mg/kg rocuronium. After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg Org 25969 was to be administered
12018709|NCT00451100|Drug|neostigmine|Subjects received a bolus dose of 0.15 mg/kg cisatracurium. After the last dose of cisatracurium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered. In accordance to the labeling of neostigmine, a maximum of 5 mg neostigmine was to be administered
12018710|NCT00451087|Procedure|leg press training|quadriceps muscle strengthening. 30min/ 3times/ week
12018711|NCT00451087|Procedure|isokinetic training|quadriceps muscle training. 30 min/ 3 times/ week
12018712|NCT00451074|Drug|Gentamicin infusions twice a week for six months|Gentamicin infusions twice a week
12018713|NCT00451061|Drug|Alfuzosin|
12018714|NCT00451061|Drug|Tamsulosin|
12018715|NCT00451048|Drug|sunitinib malate|Given orally
12018716|NCT00451035|Drug|LBH589|
12018717|NCT00451009|Device|Viacell's product Media Kits|
12018718|NCT00450996|Drug|Topical Steroids|
12018719|NCT00450983|Biological|muromonab-CD3|
12018720|NCT00450983|Biological|natural killer cell therapy|
12018721|NCT00450983|Drug|fludarabine phosphate|
12018722|NCT00450983|Drug|methotrexate|
12018723|NCT00450983|Drug|thiotepa|
12018724|NCT00450983|Genetic|gene expression analysis|
12018725|NCT00450983|Other|flow cytometry|
12018726|NCT00450983|Other|immunologic technique|
12018727|NCT00450983|Procedure|allogeneic hematopoietic stem cell transplantation|
12018728|NCT00450983|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12018729|NCT00450983|Radiation|total-body irradiation|
12018730|NCT00450970|Drug|Oral Satraplatin|The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.
12018731|NCT00450957|Dietary Supplement|lycopene|Given orally
12018732|NCT00450957|Other|pharmacological study|Correlative studies
12018733|NCT00450944|Biological|deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins|
12018734|NCT00450931|Other|counseling intervention|
12018735|NCT00450931|Other|educational intervention|
12018736|NCT00450905|Device|PRIMA Device|
12018737|NCT00450892|Drug|docetaxel+lapatinib|3 cycles of docetaxel (100 mg/m²) + lapatinib (1000 mg/d) followed by 3 cycles of FEC
12018738|NCT00450892|Drug|docetaxel + trastuzumab|3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule followed by 3 cycles of FEC 100
12018739|NCT00450892|Drug|docetaxel + trastuzumab + lapatinib|"3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule
~+lapatinib (1000 mg/d) followed by 3 cycles of FEC 100"
12018740|NCT00450879|Drug|Pazopanib Hydrochloride|Given PO
12018741|NCT00450879|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Correlative studies
12018742|NCT00450879|Other|Pharmacological Study|Correlative studies
12018743|NCT00450879|Other|Laboratory Biomarker Analysis|Correlative studies
12018744|NCT00450866|Biological|epothilone B|Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
12018745|NCT00450853|Drug|granisetron|Granisetron SC followed by granisetron IV
12018746|NCT00450840|Drug|Simvastatin|
12018747|NCT00450827|Biological|bevacizumab|
12018748|NCT00450827|Biological|filgrastim|
12018749|NCT00450827|Procedure|autologous hematopoietic stem cell transplantation|
12018750|NCT00450827|Radiation|iodine I 131 monoclonal antibody 3F8|
12018751|NCT00450814|Drug|Cyclophosphamide|Given IV
12018752|NCT00450814|Other|Laboratory Biomarker Analysis|Correlative studies
12018753|NCT00450814|Biological|Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter|Given IV
12018754|NCT00450814|Other|Pharmacological Study|Correlative studies
12018755|NCT00450801|Drug|Rituximab|Rituximab 375 mg/m2 IV, Days 1 of all cycles
12018756|NCT00450801|Drug|Cyclophosphamide|Cyclophosphamide 800 mg/m2 IV, Day 1, Cyclophosphamide 200 mg/m2 IV Days 2 - 5, Cycles 1 and 3. Cyclophosphamide will be given in 100 cc NS IV over 30 minutes.
12018757|NCT00450801|Drug|Cytarabine|Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
12018758|NCT00450801|Drug|Doxorubicin|Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
12018759|NCT00450801|Drug|Etoposide|Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
12018760|NCT00450801|Drug|Ifosfamide|Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4
12018761|NCT00450801|Drug|Leucovorin|Leucovorin 180 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 12 mg/m2 IV every 6 hours until methotrexate level is below 0.01 nM. Day 10, Cycles 1 and 3.
12018762|NCT00450801|Drug|Methotrexate|Methotrexate 1,200 mg/m2 in 250 cc 5 percent dextrose in water (D5W) IV over 1 hour followed by Methotrexate 5,520 mg/m2 in 1,000 cc D5W by continuous infusion over 23 hours (240 mg/m2 every hour for 23 hours). Day 10, Cycles 1 and 3.
12018763|NCT00450801|Drug|Thalidomide|Maintenance therapy.
12018764|NCT00450801|Drug|Vincristine|Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
12018765|NCT00450801|Drug|Mesna|Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
12018766|NCT00450801|Drug|Filgrastim (G-CSF)|G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
12018767|NCT00450801|Drug|Granisetron|Granisetron 1 mg IV on Day 1, Cycle 1 and 3
12018768|NCT00450801|Drug|Decadron|Decadron 10 mg IV on Day 1, Cycles 1 and 3
12018769|NCT00450775|Drug|Dermatix Q|Dermatix Q applied twice daily
12018770|NCT00450762|Drug|gemcitabine|
12018771|NCT00450762|Drug|carboplatin|
12018772|NCT00450749|Other|placebo|Given PO
12018773|NCT00450749|Procedure|therapeutic conventional surgery|Undergo radical prostatectomy
12018774|NCT00450749|Other|laboratory biomarker analysis|Correlative studies
12018775|NCT00450749|Drug|lycopene|Given PO
12018776|NCT00450736|Drug|celecoxib|
12018777|NCT00450736|Procedure|adjuvant therapy|
12018778|NCT00450736|Radiation|radiation therapy|
12018779|NCT00450723|Drug|Isosulfan blue|Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.
12018780|NCT00450723|Procedure|Axillary Lymph Node Dissection|Axillary Lymph Node Dissection
12018781|NCT00450723|Procedure|Surgery|The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.
12018782|NCT00450723|Procedure|Sentinel Lymph Node Biopsy|Sentinel Lymph Node Biopsy
12018783|NCT00450723|Procedure|Thoracoscopic Surgery|Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
12018784|NCT00450723|Radiation|Technetium Tc 99m Sulfur Colloid|Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots
12018785|NCT00450710|Procedure|ileal interposition with a sleeve gastrectomy|
12018786|NCT00450684|Device|Implantation and testing of CRT|Biventricular pacing for 12 weeks (CRT ON) followed by automatic rhythmicity or the original, conventional biventricular stimulation for 12 weeks (CRT OFF), then returning to biventricular pacing (CRT ON).
12018787|NCT00450684|Device|Implantation and testing of CRT|Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON).
12018788|NCT00450671|Procedure|Collagen Plug Placement|
12018789|NCT00450671|Procedure|Seton placement|
12018790|NCT00450658|Drug|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks
12018791|NCT00450658|Drug|Ibuprofen|Ibuprofen 800mg orally 3 times daily for 24 weeks
12018838|NCT00450359|Procedure|comparison of screening methods|
12018839|NCT00450359|Procedure|radiomammography|
12018840|NCT00450333|Drug|Dynepo (Epoetin delta)|subcutaneous, BIW for 24 weeks
12018841|NCT00450333|Drug|Dynepo|subcutaneous, QW for 24 weeks
12018792|NCT00450645|Drug|low molecular weight heparin|LMWH were continued for additional 6 months after detection of residual vein thrombosis (6 months after the index deep vein thrombosis) in patients randomized to group A. LMWH are stopped in patients randomized to group B or in those patients without residual vein thrombosis after 6 months from the index DVT. Dosage of LMWH are 75% of the therapeutic dosage (almost 1 mg/Kg every 12 hours)
12018793|NCT00450619|Radiation|Samarium Sm 153 lexidronam pentasodium|1 mCi/Kg given intravenous (IV)over 1 minute on day 8.
12018794|NCT00450619|Biological|Sargramostim|100 mcg/injection x 4 days given subcutaneously
12018795|NCT00450619|Biological|Recombinant vaccinia-TRICOM vaccine|2 x 10^8 PFU given subcutaneously on day 1.
12018796|NCT00450619|Biological|Recombinant fowlpox-TRICOM vaccine|1 x 10^9 PFU given subcutaneously on days 15 and 29
12018797|NCT00450606|Procedure|Balneotherapy and hydrotherapy|
12018798|NCT00450593|Genetic|gene expression analysis|
12018799|NCT00450593|Genetic|microarray analysis|
12018800|NCT00450593|Genetic|molecular genetic technique|
12018801|NCT00450593|Genetic|mutation analysis|
12018802|NCT00450593|Other|laboratory biomarker analysis|
12018803|NCT00450593|Procedure|mutation carrier screening|
12018804|NCT00450593|Procedure|study of high risk factors|
12018805|NCT00450580|Drug|fosamprenavir/ritonavir|Fosamprenavir (FPV, TELZIR) is currently licensed in Europe for twice daily (BID) dosing in combination with ritonavir (RTV, Norvir) as a boosting agent
12018806|NCT00450567|Procedure|computed tomography|
12018807|NCT00450567|Procedure|positron emission tomography|
12018808|NCT00450567|Radiation|fludeoxyglucose F 18|
12018809|NCT00450541|Behavioral|Questionnaire|Four questionnaires taking 15-20 minutes total to complete.
12018810|NCT00450541|Behavioral|Interview|Interview lasting about 30 minutes.
12018811|NCT00450515|Drug|capecitabine|
12018812|NCT00450515|Drug|vinflunine|
12018813|NCT00450502|Drug|Batracylin|
12018814|NCT00450476|Device|Hi-Lo Evac Endotracheal Tube|
12018815|NCT00450463|Drug|Sargramostim (GM-CSF, Leukine)|A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant deoxyribonucleic acid (DNA) technology in yeast Saccharomyces cerevisiae). Sargramostim is a 127 amino acid glycoprotein, altered from the native, natural human GM-CSF molecule; the position 23 arginine has been replaced with a leucine to facilitate the expression of the protein in yeast.
12018816|NCT00450463|Drug|Flutamide (Eulexin)|Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex.
12018817|NCT00450463|Biological|PROSTVAC-F/ TRICOM|A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three costimulatory molecules.
12018818|NCT00450463|Biological|PROSTVAC-V/TRICOM|A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.
12018819|NCT00450450|Procedure|allogeneic bone marrow transplantation|Patients undergo allogeneic BMT
12018820|NCT00450450|Other|laboratory biomarker analysis|Correlative studies
12018821|NCT00450450|Biological|filgrastim|Given IV
12018822|NCT00450437|Biological|MenACWY CRM|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
12018823|NCT00450437|Biological|Meningococcal ACWY Conjugate vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
12018824|NCT00450424|Other|counseling intervention|Participants in the Counseling intervention will meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
12018825|NCT00450424|Other|CD-ROM intervention|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
12018826|NCT00450411|Radiation|125-Iodine|Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy
12018827|NCT00450411|Radiation|103-palladium|Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy
12018828|NCT00450398|Drug|YSPSL|YSPSL administered as an ex vivo flush (20 mg YSPSL in Viaspan® 200 mL total volume) into the portal vein prior to transplant at the back table; YSPSL 1 mg/kg administered IV to the transplant recipient prior to arterial reperfusion of the liver.
12018829|NCT00450398|Drug|Placebo|Ex vivo flush of placebo control (200 mL Viaspan®) into the portal vein prior to transplant and 0.1 mL/kg placebo control (saline) IV to the transplant recipient prior to arterial reperfusion of the liver.
12018830|NCT00450385|Drug|Rituximab|Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
12018831|NCT00450385|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
12018832|NCT00450385|Drug|Doxorubicin|Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
12018833|NCT00450385|Drug|Prednisone|Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
12018834|NCT00450385|Drug|Vincristine|Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles
12018835|NCT00450372|Biological|ADI-PEG-20|There will be 6 cycles planned, each consisting of 4 weeks. During each cycle subjects will receive injections on days 1, 8, 15, and 22 + 2 days. All subjects may begin treatment with 160 IU/m2 on a weekly basis.
12018836|NCT00450372|Other|Pharmacology Studies|tissue blocks will be obtained from the initial biopsy of melanoma. Immunohistochemical staining for ASS and RT-PCR will be performed on the tumor tissue
12018837|NCT00450359|Procedure|breast imaging study|
12018842|NCT00450333|Drug|Dynepo|subcutaneous, QW for 24 weeks
12018843|NCT00450333|Drug|Dynepo|subcutaneous, Q2W for 24 weeks
12018844|NCT00450320|Drug|sirolimus|The target rapamycin trough level will be 5-10 ng/mL. The initial dose will be dependent upon the type of HAART regimen. Subjects will continue on study protocol for six cycles as long as their KS is stable or continuing to respond to study medication. Treatment will be extended for up to six additional cycles if the subject has met criteria for a response. Subjects with no more than stable disease will have treatment discontinued after six cycles. Protocol treatment will be discontinued if the subject develops tumor progression, unacceptable toxicity or develops one of the protocol-defined reasons for treatment discontinuation at any time during the study.
12018845|NCT00450307|Biological|monoclonal antibody 3F8|
12018846|NCT00450307|Biological|sargramostim|
12018847|NCT00450281|Genetic|chromogenic in situ hybridization|
12018848|NCT00450281|Genetic|gene expression analysis|
12018849|NCT00450281|Genetic|mutation analysis|
12018850|NCT00450281|Genetic|polymerase chain reaction|
12018851|NCT00450281|Genetic|polymorphism analysis|
12018852|NCT00450281|Other|fluorescent antibody technique|
12018853|NCT00450281|Other|immunohistochemistry staining method|
12018854|NCT00450281|Other|laboratory biomarker analysis|
12018855|NCT00450281|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
12018856|NCT00450281|Other|study of socioeconomic and demographic variables|
12018857|NCT00450281|Procedure|study of high risk factors|
12018858|NCT00450268|Procedure|blood draw, skin shave biopsy|
12018859|NCT00450255|Biological|ziv-aflibercept|Given IV
12018860|NCT00450255|Other|pharmacological study|Correlative studies
12018861|NCT00450242|Drug|5% topical lidocaine ointment|Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.
12018862|NCT00450242|Drug|Placebo cream|hydrophilic petrolatum, dime-sized amount, applied nightly.
12018863|NCT00450229|Drug|diindolylmethane|Given PO
12018864|NCT00450229|Drug|placebo|Given PO
12018865|NCT00450229|Procedure|therapeutic conventional surgery|Undergo surgical resection
12018866|NCT00450229|Other|laboratory biomarker analysis|Correlative studies
12018867|NCT00450229|Other|pharmacological study|Correlative studies
12018868|NCT00450216|Drug|Ibuprofen/famotidine|HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks
12018869|NCT00450216|Drug|Ibuprofen|Ibuprofen 800mg administered orally 3 times daily for 24 weeks
12018870|NCT00450203|Biological|bevacizumab|7.5mg/kg IV Day 1 of each 21 cycle of chemotherapy (6 cycles) plus day 1 of each maintenance dose every 21 days for 6 doses.
12018871|NCT00450203|Drug|capecitabine|dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)
12018872|NCT00450203|Drug|cisplatin|60mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
12018873|NCT00450203|Drug|Epirubicin|50mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
12018874|NCT00450203|Procedure|adjuvant therapy|3 cycles of ECX chemotherapy post operatively
12018875|NCT00450203|Procedure|conventional surgery|Surgery undertaken after 3 cycles of pre-operative chemotherapy. Followed by 3 cycles of chemotherapy.
12018876|NCT00450203|Procedure|neoadjuvant therapy|3 cycles of pre-operative ECX chemotherapy.
12018877|NCT00450203|Drug|Lapatinib|1250mg/day Day 1-21 of each cycle of chemotherapy (6 cycles) plus day 1-21 of each maintenance course every 21 days for 6 doses.
12018878|NCT00450190|Device|Saizen® E-Device|Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
12018879|NCT00450177|Drug|Ferrous Sulfate|Iron group
12018880|NCT00450177|Drug|Placebo Oral Tablet|Placebo group
12018881|NCT00450164|Procedure|esofagic varices ligation|
12018882|NCT00450164|Drug|Nadolol|
12018883|NCT00450164|Drug|Isosorbide mononitrate|
12018884|NCT00450164|Drug|Prazosin|
12018885|NCT00450138|Drug|ZD6474 (vandetanib)|once daily oral dose
12018886|NCT00450138|Drug|Cisplatin|intravenous infusion
12018887|NCT00450138|Radiation|Radiation|radiation of head and neck
12018888|NCT00450125|Other|Six-Minute Walk Test|Six-Minute walk tests at least one hour after vigorous exertion (such as exercise stress test) and at least 20 minutes in between the first and second six-minute walk tests
12018889|NCT00450125|Other|Exercise stress test|Scheduled gold standard exercise test, i.e. stress test, cycle ergometry with incremental workloads or oxygen consumption exercise studies
12018890|NCT00450112|Device|Gel-200|Single Intra-articular Injection
12018891|NCT00450099|Drug|bupivacaine|0.125% bupivacaine in a volume determined according to the biased coin up-down sequential allocation model, starting at 8mL.
12018892|NCT00450086|Drug|Budesonide|9 mg per day
12018893|NCT00450086|Drug|Mesalazine|3 g per day
12018894|NCT00450086|Drug|Placebo|0 g per day
12018895|NCT00450073|Drug|ergocalciferol (vitamin D2)|50,000 IU weekly
12018896|NCT00450073|Device|Sperti Del Sol Lamp|5 times a week for 12 weeks
12018897|NCT00450073|Drug|Vitamin D3|50,000 IU weekly
12018898|NCT00450060|Device|lumbar puncture with Quincke-design needles|
12018899|NCT00450060|Device|lumbar puncture with Sprotte-design needles|
12018900|NCT00450047|Device|Speed-feedback therapy system with a bicycle ergometer|
12018901|NCT00450047|Device|Ergometer at conventional settings|
12018902|NCT00450034|Procedure|drug - oriented multifaceted intervention|oriented multifaceted intervention
12018903|NCT00450021|Drug|[(11)C] MePPEP|
12018904|NCT00450008|Drug|GM-CSF|fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection
12018905|NCT00450008|Drug|thalidomide|Thalidomide by oral administration at a fixed dose of 200 mg. Prophylactic Coumadin® by oral administration at a fixed dose of 2.5 mg to prevent thromboembolic events (DVT and TIA/stroke) during Thalidomide administration. Thalidomide and Coumadin will be given daily at bedtime without interruption.
12019187|NCT00447928|Drug|OrthoDerm transdermal nitroglycerin patch|
12018906|NCT00450008|Drug|docetaxel|Docetaxel will be administered by intravenous piggyback over 1 hour at 75mg/m² every 3 weeks. Pre-medication for the docetaxel infusion will consist of dexamethasone 8 mg administered orally 12 hours, 3 hours and 1 hour before docetaxel.
12018907|NCT00449995|Procedure|confocal laser microscopy|
12018908|NCT00449982|Drug|Polyphenon E Ointment 10%, Polyphenon E Ointment 15%|
12018909|NCT00449969|Device|Zoll AED pro|Arm one (Extended feedback) offers full feedback guidance during CPR
12018910|NCT00449969|Device|Zoll AED pro|In arm two (limited feedback) feedback is modified lacking several elements of feedback
12018911|NCT00449956|Drug|dorzolamide hydrochloride (+) timolol maleate|Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week
12018912|NCT00449956|Drug|Comparator: timolol maleate|timolol maleate 0.5%, 8-week
12018913|NCT00449956|Drug|Comparator: dorzolamide hydrochloride|dorzolamide hydrochloride 1%, 8-week
12018914|NCT00449943|Procedure|Computed Tomographic Angiography|CT scan
12018915|NCT00449943|Procedure|Myocardial Perfusion Imaging Scan|SPECT
12018916|NCT00449930|Drug|sitagliptin phosphate|(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
12018917|NCT00449930|Drug|Comparator: metformin hydrochloride|(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.
12018918|NCT00449917|Drug|lutein|
12018919|NCT00449917|Drug|DHA|
12018920|NCT00449917|Drug|vitamins|
12018921|NCT00449904|Drug|Liprotamase|Administered orally
12018922|NCT00449878|Drug|Liprotamase|Administered orally
12018923|NCT00449878|Drug|Placebo|Administered orally
12018924|NCT00449865|Drug|creatine|"Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
~The study is comparing creatine 5 grams twice daily with placebo."
12018925|NCT00449865|Other|placebo|an inactive substance
12018926|NCT00449852|Behavioral|Interactive Voice Response|The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.
12018927|NCT00449839|Drug|Insulin Aspart|"A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus.
~C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted."
12018928|NCT00449826|Procedure|Computed Tomographic Angiography|CT scan
12018929|NCT00449813|Drug|Pantoprazole|40 mg Pantoprazole
12018930|NCT00449800|Drug|ceftriaxone|
12018931|NCT00449787|Drug|Sumatriptan 100 mg|Sumatriptan 100mg tablet
12018932|NCT00449787|Drug|Naproxen|Naproxen 500mg tablet
12018933|NCT00449774|Drug|Lamotrigine IR tablets|Lamotrigine IR tablets will be available in dose strength of 200 mg.
12018934|NCT00449774|Drug|Lamotrigine ODT tablets|Lamotrigine ODT tablets will be available in dose strength of 200 mg.
12018935|NCT00449761|Drug|panobinostat|LBH589
12018936|NCT00449748|Drug|RAD001 (Everolimus)|Oral RAD001 10 mg daily for 30 days
12018937|NCT00449722|Drug|mesalazine|
12018938|NCT00449709|Drug|GSK221149|
12018939|NCT00449696|Device|Gel-200|Single intra-articular injection
12018940|NCT00449696|Device|Placebo|Single intra-articular injection
12018941|NCT00449683|Drug|terazosin|off-label use of terazosin to treat antidepressant-induced sweating
12018942|NCT00449670|Biological|H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)|Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
12018943|NCT00449670|Biological|H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)|Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
12018944|NCT00449670|Biological|H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)|Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.
12018945|NCT00449657|Drug|Taxol (paclitaxel)|paclitaxel 15mg/m2 Q am on Mon/Wed/Fri
12018946|NCT00449657|Procedure|Radiotherapy|"Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before.
~Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5"
12018947|NCT00449657|Drug|Carboplatin|Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 & 9
12018948|NCT00449657|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 & 9
12018949|NCT00449644|Drug|TMC207|TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.
12018950|NCT00449644|Drug|Placebo|Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.
12018951|NCT00449644|Drug|Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)|Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
12018952|NCT00449618|Drug|Aspirin 100 mg|dose of 100 mg administered on awakening or at bedtime
12018953|NCT00449618|Device|Ambulatory blood pressure monitoring|Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
12018954|NCT00449618|Procedure|Chronotherapy, timing of medication|Dosing on awakening versus bedtime
12018955|NCT00449618|Drug|Placebo|Use of placebo on awakening versus bedtime
12018956|NCT00449605|Drug|Rimonabant|Tablet, oral administration
12018957|NCT00449605|Drug|Glimepiride|Tablet, oral administration
12018958|NCT00449605|Drug|Metformin|Metformin continued at stable dose as background therapy
12018959|NCT00449592|Drug|Zinc|Oral Zincol 1 Tab TID from day -6/-7 until discharge
12018960|NCT00449592|Drug|Placebo|Oral placebo 1 Tab TID from day -6/-7 until discharge
12018961|NCT00449579|Device|Excercise stress test with high frequency ECG recording (HyperQ™ System)|
12018962|NCT00449553|Drug|Pioglitazone and sulphonylurea|Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
12018963|NCT00449553|Drug|Pioglitazone and sulphonylurea|Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
12018964|NCT00449553|Drug|Pioglitazone and metformin|Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
12018965|NCT00449553|Drug|Pioglitazone and metformin|Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
12018966|NCT00449540|Device|Active Transcranial Magnetic Stimulation (TMS) Device|Transcranial Magnetic Stimulation Device treatment
12018967|NCT00449540|Device|Sham TMS Device|Simulated Sham treatment without TMS delivery
12018968|NCT00449527|Drug|Budesonide/formoterol pMDI|
12018969|NCT00449527|Drug|Budesonide HFA pMDI|
12018970|NCT00449514|Drug|tamoxifen|
12018971|NCT00449514|Drug|clomiphene citrate|
12018972|NCT00449501|Drug|Budesonide/formoterol pMDI|
12018973|NCT00449501|Drug|Budesonide HFA pMDI|
12018974|NCT00449488|Drug|epoetin alfa|epoetin alfa 60.000 IU one i.v. bolus
12018975|NCT00449462|Procedure|consumption of CLA enriched food|
12018976|NCT00449449|Drug|Pertubation with Lidocain Solution|
12018977|NCT00449436|Drug|TRIZIVIR|TRIZIVIR
12018978|NCT00449436|Drug|Non-nucleoside reverse transcriptase inhibitor|Non-nucleoside reverse transcriptase inhibitor
12018979|NCT00449436|Drug|Boosted Protease Inhibitor|Boosted Protease Inhibitor
12018980|NCT00449423|Drug|acipimox|
12018981|NCT00449410|Drug|Atorvastatin|
12018982|NCT00449410|Drug|ezetimibe|
12018983|NCT00449397|Drug|Quetiapine Fumarate|
12018984|NCT00449384|Behavioral|Diagnostic Screening|
12018985|NCT00449358|Procedure|apply methyl-ALA cream|
12018986|NCT00449345|Procedure|Blood test for Quantiferon-GOLD assay|
12018987|NCT00449319|Procedure|Identification of appropriate therapies according to risks factors|
12018988|NCT00449319|Drug|Daunorubicine|
12018989|NCT00449319|Procedure|Transplant|
12018990|NCT00449293|Behavioral|standard cognitive behavioral therapy|Standard therapy to help participants with smoking cessation.
12018991|NCT00449293|Behavioral|Mindfulness Based Cognitive Therapy|A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.
12018992|NCT00449280|Drug|Sorafenib|400mg BID (200 mg twice daily)
12018993|NCT00449280|Drug|Rapamycin|30mg once weekly
12018994|NCT00449280|Drug|Rapamycin|3mg once daily
12018995|NCT00449267|Device|Intraocular Lens|Phacoemulsification with in the bag implantation of the IOL
12018996|NCT00449254|Drug|oleoyl-estrone (MP-101)|
12018997|NCT00449241|Device|Acupuncture|
12018998|NCT00449228|Procedure|-preoperative education and total hip replacement|-preoperative education and total hip replacement
12018999|NCT00449202|Drug|oleoyl-estrone (MP 101)|
12019000|NCT00449176|Drug|tapentadol (CG5503) ER|50, 100, 150, 200, 250 mg twice daily for 15 weeks
12019001|NCT00449176|Drug|oxycodone CR|10, 20, 30, 40, 50 mg twice daily for 15 weeks
12019002|NCT00449176|Drug|placebo|matching placebo twice daily for 15 weeks
12019003|NCT00449163|Biological|Bevacizumab|
12019004|NCT00449163|Drug|Floxuridine|
12019005|NCT00449163|Drug|Irinotecan|
12019006|NCT00449163|Drug|Leucovorin|
12019007|NCT00449150|Drug|Cetrorelix 78 mg + 78 mg|
12019008|NCT00449150|Drug|Cetrorelix 78 mg + 52 mg|
12019009|NCT00449150|Drug|Placebo|
12019010|NCT00449137|Drug|Arsenic trioxide|ATO will be administered at dose levels determined by the dose escalation scheme (section 4.2). Intra-venous (IV) infusion of ATO (mg/kg body weight) over 1-4 hours will be administered for 5 consecutive days (day 1 to day 5) during the first week, twice a week on weeks 2 and 3 (days 8, 11, 15, and 18), and only one day (day 22) of week 4. Treatment will continue for a maximum of 8 cycles, provided that the patient tolerates treatment and there is evidence of clinical benefit.
12019011|NCT00449137|Drug|Fluorouracil|Escalate 5-FU, starting at dose 1600 mg/m2. On day 8, 15, and 22 the assigned dose of 5 FU plus 500 mg/m2 of leucovorin will be administered over 24 hours intravenous infusion following the administration of arsenic trioxide. Treatment will continue for a maximum of 8 cycles, provided that the patient tolerates treatment and there is evidence of clinical benefit.
12019012|NCT00449137|Drug|Leucovorin calcium|On day 8, 15, and 22 the assigned dose of 5 FU plus 500 mg/m2 of leucovorin will be administered over 24 hours intravenous infusion following the administration of arsenic trioxide. Treatment will continue for a maximum of 8 cycles, provided that the patient tolerates treatment and there is evidence of clinical benefit.
12019013|NCT00449137|Other|Plasma levels of elemental arsenic|Pre-Treatment and and one hour post ATO on days 1, 5, 8, 11,15, 18, and 22
12019014|NCT00449137|Genetic|Peripheral Blood Mononuclear Cells (PBMC) for mRNA analysis|Peripheral blood samples (PAXgene Blood RNA tube, Qiagen, USA) will be obtained up to 2 weeks prior to start of treatment (same day as the first FNA) and one hour post ATO on days 1, 5, 8, 11,15, 18, and 22. Along with FNA an additional blood sample will be obtained on day 23 of every odd treatment cycle.
12019015|NCT00449137|Procedure|Tumor Biopsy (Fine-Needle Aspiration)|Pre-Treatment, Day 23 of Cycles 1, 3, 5, 7
12019016|NCT00449124|Drug|Placebo|Injections of 0.5 mL of normal saline solution (0.9% NaCl).
12019017|NCT00449124|Biological|TG4040|Modified vaccinia virus Ankara encoding hepatitis C virus (HCV) proteins NS3, NS4, and NS5B administered by subcutaneous injection into the thigh. Dosages: TG4040 10^6 PFU, TG4040 10^7 PFU and TG4040 10^8 PFU.
12019018|NCT00449111|Drug|MK0954, losartan potassium / Duration of Treatment - 12 weeks|
12019019|NCT00449098|Device|OculusGen Biodegradable Collagen Matrix Implant|Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
12019020|NCT00449098|Drug|Trabeculectomy with MMC|Trabeculectomy with MMC
12019021|NCT00449085|Procedure|Electrophysiology|
12019022|NCT00449085|Device|CARTO™ XP EP Navigation System V9|
12019023|NCT00449072|Other|Placebo|Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration
12019024|NCT00449072|Other|Placebo|Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period
12019025|NCT00449072|Drug|TAA-AQ, Nasacort® AQ|110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period
12019026|NCT00449072|Drug|Claritin®|Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label
12019027|NCT00449059|Drug|acute infusion of nitroglycerine into the pulmonary artery|
12019028|NCT00449046|Drug|GW815SF Salmeterol/Fluticasone propionate(HFA MDI)|
12019029|NCT00449033|Drug|Sorafenib (Nexavar, BAY43-9006)|Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m^2 IV, Cisplatin 75 mg/m^2 IV
12019030|NCT00449033|Drug|Placebo|Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m^2 IV, Cisplatin 75 mg/m^2 IV
12019031|NCT00449033|Drug|Gemcitabine|Chemotherapy component; Gemcitabine 1250 mg/m^2 IV
12019032|NCT00449033|Drug|Cisplatin|Chemotherapy component; Cisplatin 75 mg/m^2 IV
12019033|NCT00449020|Drug|Carboplatin|CARBOPLATIN (AUC=2) IV in 250 cc NS over 30 minutes, weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
12019034|NCT00449020|Drug|Docetaxel|DOCETAXEL 75 mg/m2 IV over one hour every three weeks for 3 cycles.
12019035|NCT00449020|Drug|irinotecan hydrochloride|IRINOTECAN 30 mg/m2 IV over 90 minutes weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
12019036|NCT00449020|Radiation|radiation therapy|Radiotherapy will start on the first day of scheduled chemotherapy. The daily administered dose will be 1.8 Gy, 5 days a week for 4.4 weeks, 22 fractions, ( 39.6 Gy) to the primary tumor and mediastinum (primary planning target volume: PPTV). After 39.6 Gy, the same targets will be treated by oblique fields at 1.8 GY for 3 fxs to a toal dose of 45 GY. Thereafter, the primary tumor and involved nodal metastasis (secondary planning target volume SPTV) will be boosted at 2 Gy per day to 18 Gy in 9 fractions. The total dose will be 63 Gy in 35 fractions over seven weeks.
12019037|NCT00449007|Drug|fluoxetine|6 months
12019038|NCT00449007|Drug|bupropion|6 months
12019039|NCT00448981|Behavioral|Hand hygiene and educational material|
12019040|NCT00448981|Device|Mask, alcohol and hand sanitizer|
12019041|NCT00448955|Drug|ARD-0403|ARD-0403
12019042|NCT00448942|Behavioral|Daily bathing with Chlorhexidine based product|
12019043|NCT00448929|Device|OculusGen Biodegradable Collagen Matrix Implant|Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
12019044|NCT00448916|Drug|Pregabalin|Orally-administered pregabalin
12019045|NCT00448903|Drug|Bemiparin|Bemiparin sodium
12019046|NCT00448903|Drug|Placebo|Sodium Chloride 0,9%
12019047|NCT00448890|Drug|GSK729327|Tablets
12019048|NCT00448890|Drug|Placebo|GSK729327 Matching placebo - Tablets
12019049|NCT00448877|Device|fNIR light emitting and sensing device|
12019050|NCT00448864|Drug|Ecallantide|
12019051|NCT00448864|Drug|Placebo|
12019052|NCT00448851|Biological|inhaled allergen challenge|Subjects will inhale gradually increasing concentrations of Dermatophagoides farinae until a 15% drop in FEV1 is noted
12019053|NCT00448838|Biological|Cetuximab|Cetuximab: an initial loading dose of 400 mg/m2 will be given followed by 250 mg/m2 administered weekly. Cetuximab will be given first followed by gemcitabine on the weeks the patient receives cytotoxic chemotherapy on day 1. Cetuximab will be given as a single agent on Day 8. The treatment will be given on two-week cycles.
12019054|NCT00448838|Drug|Gemcitabine Hydrochloride|Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.
12019055|NCT00448838|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.
12019056|NCT00448825|Drug|Topiramate + Cognitive Behavioral Therapy|Topiramate up to 300 mg per day
12019057|NCT00448825|Drug|Placebo + Cognitive Behavioral Therapy|Placebo twice a day
12019058|NCT00448799|Radiation|[123-I] AV-83 Injection and Imaging Procedures|Evaluation of [123I] AV83 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
12019059|NCT00448786|Drug|AMG 706|Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off
12019060|NCT00448786|Drug|AMG 706|Arm C - 75 mg BID 5-days on, 2-days off
12019061|NCT00448786|Drug|AMG 706|AMG 706 125 mg daily continuously (Arm A)
12019062|NCT00448773|Behavioral|Online education|
12019063|NCT00448760|Drug|Docetaxel|Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
12019064|NCT00448760|Drug|Floxuridine|Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
12019065|NCT00448760|Drug|Leucovorin|Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
12019066|NCT00448760|Drug|Oxaliplatin|Intravenously, 85 mg/m2, over 2 hours, 2 cycles
12019067|NCT00448760|Genetic|Microarray analysis|Analysis of tumor for pathologic response to protocol therapy
12019068|NCT00448760|Genetic|reverse transcriptase-polymerase chain reaction|Analysis of tumor for pathologic response to protocol therapy
12019069|NCT00448760|Procedure|Conventional surgery|Surgical removal of tumor for correlative studies
12019070|NCT00448747|Drug|AEZS-130 (formerly ARD-07)|A single oral administration of AEZS-130 as Growth Hormone Stimulation Test
12019071|NCT00448747|Drug|L-ARG+GHRH|A single administration of L-ARG+GHRH (iv bolus) followed by a 30min infusion of L-ARG as Growth Hormone Stimulation Test
12019072|NCT00448734|Drug|Picoplatin|"The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
~Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion."
12019129|NCT00448266|Drug|Intensified Cyclophophamide, Carboplatin and Thiotepa|2 courses of Intensified Cyclophophamide, Carboplatin and Thiotepa with PBPC support
12019130|NCT00448266|Drug|dose dense adriamycine and cyclophosphamide|dose dense adriamycine and cyclophosphamide, Q 2 weeks
12019188|NCT00447915|Drug|ibandronic acid 0.5mg|0.5mg(i.v.)/month for 35 months
12019073|NCT00448734|Drug|docetaxel|"The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
~Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion."
12019074|NCT00448721|Drug|Perifosine|Perifosine will be administered orally at 100mg PO daily with food.
12019075|NCT00448708|Device|Vascular Wrap Paclitaxel-Eluting Mesh|0.9 µg/mm^2 paclitaxel
12019076|NCT00448708|Device|Lifespan® ePTFE Vascular Graft|vascular graft
12019077|NCT00448708|Device|Lifespan® ePTFE Vascular Graft|vascular graft
12019078|NCT00448695|Procedure|MRI Targeted Focal Thermal Therapy of Prostate Cancer|The Interstitial Laser Thermal Therapy (LTT) procedure is similar to brachytherapy, with fibers and probes inserted trans-perineal using transrectal ultrasound guidance. Patients will be under general anesthetic, and the procedure is expected to last 3 hours. Patients will be able to return home the day of the procedure.
12019079|NCT00448682|Drug|Docetaxel|
12019080|NCT00448682|Drug|Floxuridine|
12019081|NCT00448682|Drug|Leucovorin|
12019082|NCT00448682|Drug|Oxaliplatin|
12019083|NCT00448669|Drug|Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg|
12019084|NCT00448669|Drug|Placebo Oral Tablet|
12019085|NCT00448656|Procedure|ablation of pulmonary veins by video assisted thoracic surgery|epicardial ablation using HIFU
12019086|NCT00448643|Radiation|Vaginal Brachytherapy|High-Dose Rate [HDR] or Low-Dose Rate [LDR], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy
12019087|NCT00448643|Drug|Cisplatin|Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy
12019088|NCT00448643|Radiation|Whole Abdominal Radiation [WAR] Therapy|Whole Abdominal Radiation Therapy, Dose Escalated [2-Levels]; 6 -8 hours after administration of Cisplatin chemotherapy
12019089|NCT00448630|Other|No intervention|Non-interventional study
12019090|NCT00448591|Drug|bevacizumab [Avastin]|10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
12019091|NCT00448591|Drug|Taxane-based chemotherapy|As prescribed
12019092|NCT00448578|Drug|Quetiapine Fumarate|
12019093|NCT00448578|Drug|Lithium|
12019094|NCT00448552|Drug|capecitabine|
12019095|NCT00448552|Drug|oxaliplatin|
12019096|NCT00448539|Drug|Rufinamide|Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
12019097|NCT00448526|Behavioral|low protein diet|
12019098|NCT00448513|Dietary Supplement|catechin extracts|comparison with placebo
12019099|NCT00448474|Behavioral|Mailed Arthritis Self-Management Education|
12019100|NCT00448461|Drug|heparin|comparison between heparin and bivalirudin
12019101|NCT00448461|Drug|bivalirudin|comparison between heparin and bivalirudin
12019102|NCT00448448|Device|Brace|Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months.
12019103|NCT00448448|Other|Observation|Clinical, radiographic, and self-report follow-up every 6 months.
12019104|NCT00448435|Drug|GW815SF HFA MDI|salmeterol and fluticasone propionate combination
12019105|NCT00448435|Drug|salmeterol and fluticasone propionate|salmeterol + fluticasone propionate
12019106|NCT00448422|Drug|prulifloxacin|Tablet
12019107|NCT00448409|Biological|TroVax|11 Intramuscular injection of TroVax® over 45 weeks. A single dose of 5 x 108 pfu/ml, will be given by an intramuscular injection into the deltoid muscle of the upper arm.
12019108|NCT00448409|Drug|GM-CSF|168 subcutaneous GM-CSF injections over 45 weeks. Administered every day as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) in weeks 1 and 2 of each 28 day cycle (total of 14 days per cycle with a total of 12 cycles).
12019109|NCT00448396|Drug|Patupilone|
12019110|NCT00448383|Biological|adalimumab|40mg every other week
12019111|NCT00448357|Biological|rabbit anti-thymocyte globulin (ATG)|.5 mg/kg on day -3 and 2.5 mg/kg on day -2
12019112|NCT00448357|Biological|therapeutic allogeneic lymphocytes|minimum total cluster of differentiation (CD34+) cells of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on day 0
12019113|NCT00448357|Drug|busulfan|PK-targeted continuous IV infusion over 90 hours on Days -7 to -4.
12019114|NCT00448357|Drug|fludarabine phosphate|30 mg/m^2/day x 5 days intravenous piggyback (IVPB) over 30 minutes on Days -7 through -3
12019115|NCT00448357|Drug|tacrolimus|The suggested starting dose is 0.03 mg/kg po bid starting on day -1
12019116|NCT00448357|Procedure|allogeneic hematopoietic stem cell transplantation|A minimum total CD34+ cell dose of 3 x 10^6 cells/kg and maximum of 8 x 10^6 cells/kg will be infused on day 0
12019117|NCT00448357|Procedure|peripheral blood stem cell transplantation|minimum total CD34+ cell dose of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on day 0
12019118|NCT00448357|Drug|methotrexate|5 mg/m^2 on days +1, +3 and +6
12019119|NCT00448344|Behavioral|Family-supported|Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking
12019120|NCT00448344|Behavioral|Standard Telephone counseling|Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
12019121|NCT00448318|Procedure|Music Therapy|
12019122|NCT00448305|Drug|EndoTAG-1 + paclitaxel|EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
12019123|NCT00448305|Drug|EndoTAG-1|EndoTAG-1 44 mg/m² twice weekly
12019124|NCT00448305|Drug|Paclitaxel|Paclitaxel 90 mg/m² weekly
12019125|NCT00448292|Drug|PRX-00023|Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
12019126|NCT00448292|Drug|Placebo for PRX-00023|Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
12019127|NCT00448279|Drug|trastuzumab|2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
12019128|NCT00448279|Drug|Chemotherapy|Schedule and dose at the investigator's discretion
12019131|NCT00448253|Biological|NP-015|"Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo.
~And a Fourth Cohort at 840 units TNA with 2 additional product lots."
12019132|NCT00448240|Drug|Erlotinib|loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
12019133|NCT00448227|Drug|famciclovir|Administered orally as a single individualized dose between 25-200 mg based on body weight.
12019134|NCT00448214|Drug|YM150|Oral
12019135|NCT00448214|Drug|warfarin|Oral
12019136|NCT00448201|Biological|anti-thymocyte globulin|0.5 mg/kg on day -3, 2.5 mg/kg on day -2 (groups 2, 3 and 4) and 3 mg/kg on day -1 (group 4 only)
12019137|NCT00448201|Biological|sargramostim|GM-CSF 500 ug everyday (QD) subcutaneously will be given to recipients who remain with an Absolute neutrophil count (ANC) < 1000/microliter (uL) past day 20
12019138|NCT00448201|Biological|therapeutic allogeneic lymphocytes|A minimum total cluster of differentiation 34 (CD34)+ cell dose of 3 x 10^6 cells/kg and a maximum 8 x 10^6 cells/kg will be infused on day 0
12019139|NCT00448201|Drug|busulfan|6.4 mg/kg by continuous IV infusion over 48 hours on Days -6 and -5
12019140|NCT00448201|Drug|fludarabine phosphate|fludarabine 30 mg/m^2/day x 5 days IV piggyback (IVPB) over 30 minutes on Days -7 through -3
12019141|NCT00448201|Drug|methotrexate|Methotrexate 5 mg/m^2 per day on days +1, +3 and +6
12019142|NCT00448201|Drug|tacrolimus|Suggested starting dose is 0.03 mg/kg po bid starting on Day -1
12019143|NCT00448201|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Minimum total CD34+ cells of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on Day 0
12019144|NCT00448201|Procedure|peripheral blood stem cell transplantation|Minimum total CD34+ cells of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on Day 0
12019145|NCT00448188|Procedure|central venous catheter application|
12019146|NCT00448175|Device|Urgent PC Neuromodulation System|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
12019147|NCT00448175|Drug|Tolterodine|
12019148|NCT00448149|Drug|RAD001|RAD001 will be administered orally once a day, daily, without interruption per 4 wk cycle for 2 cycles. MTD is established in Phase I portion of trial (2.5, 5 or 10mg). If responding, additional therapy will be given.
12019149|NCT00448149|Drug|Sorafenib|A dose of 400mg of Nexavar® will be administered orally twice a day, daily, without an interruption per 4 week cycle for 2 cycles. If responding, additional therapy will be given.
12019150|NCT00448136|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 every 3 weeks
12019151|NCT00448136|Drug|5 FU|400mg/m2/day iv on days 1-5 every 6 weeks
12019152|NCT00448136|Drug|Streptozotocin|500mg/m2/day iv on days 1-5 every 6 weeks
12019153|NCT00448136|Drug|Xeloda|1000mg/m2 po bid on days 1-14 every 3 weeks
12019154|NCT00448123|Drug|Tamsulosin|Study Drug
12019155|NCT00448123|Drug|Placebo|Placebo
12019156|NCT00448110|Drug|Intravenous Diclofenac (DIC075V)|Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
12019157|NCT00448110|Drug|Intravenous Ketorolac|Intravenous Ketorolac
12019158|NCT00448110|Drug|placebo|placebo
12019159|NCT00448097|Drug|cetuximab|No verifiable data available, PI relocated
12019160|NCT00448097|Drug|docetaxel|No verifiable data available, PI relocated
12019161|NCT00448071|Drug|MTR107|
12019162|NCT00448058|Drug|GSK372475|daily administration during the 10-week treatment phase
12019163|NCT00448058|Drug|venlafaxine|daily administration during the 10-week treatment phase
12019164|NCT00448058|Drug|placebo|daily administration during the 10-week treatment phase
12019165|NCT00448045|Behavioral|Manual and mechanical assisted cough|Individuals will be given a pulse oximeter and taught both manually assisted and mechanically assisted coughing techniques to maximize their cough. Manually assisted coughing consists of air stacking to deep insufflations. An abdominal thrust is then applied upon glottic opening to augment the cough. These subjects will also have rapid access to a mechanical in-exsufflator (CoughAssistTM) and will be trained on how to access and use this device. Mechanically assisted coughing (MAC) involves the use of the CoughAssistTM to expand the lungs and then quickly reverse the pressure to rapidly empty the lungs with expiratory (cough) flows of 600 L/m. An abdominal (manual) thrust is applied in conjunction with the negative pressure (exsufflation) to further increase cough.
12019166|NCT00448045|Behavioral|Incentive spirometry|These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
12019167|NCT00448032|Drug|PPM-204|
12019168|NCT00448019|Drug|Fludarabine|25 mg/m^2 IV over 30 minutes daily for 3 days
12019169|NCT00448019|Drug|Cyclophosphamide|250 mg/m^2 IV over 30 minutes daily for 3 days
12019170|NCT00448019|Drug|Rituximab|375 mg/m^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m^2 IV 30-minute infusion.
12019171|NCT00448019|Drug|Bevacizumab|10 mg/Kg IV on Day 3, course 1 over 30-90 minutes
12019172|NCT00448006|Device|Allium Biliary Stent|device
12019173|NCT00448006|Device|allium biliary stent|allium biliary stent
12019174|NCT00447993|Drug|NT-501|High Dose
12019175|NCT00447993|Drug|NT-501|Low Dose
12019176|NCT00447980|Drug|NT-501|High Dose
12019177|NCT00447980|Drug|NT-501|Low Dose
12019178|NCT00447967|Drug|Irinotecan|Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
12019179|NCT00447967|Drug|Oxaliplatin|Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
12019180|NCT00447967|Drug|Fluorouracil|Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles
12019181|NCT00447967|Drug|Leucovorin|Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles
12019182|NCT00447967|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles
12019183|NCT00447954|Drug|NT-501 implant|High Dose
12019184|NCT00447954|Drug|NT-501 implant|Low Dose
12019185|NCT00447954|Other|Sham Procedure|Sham Procedure
12019186|NCT00447941|Drug|SCA-136|
12019189|NCT00447915|Drug|RIS placebo|0 mg(p.o.)/day for 36 months
12019190|NCT00447915|Drug|1.0mg ibandronic acid|1.0mg(i.v.)/month for 35 months
12019191|NCT00447915|Drug|ibandronic acid placebo|0mg(i.v.)/month for 35 months
12019192|NCT00447915|Drug|2.5mg RIS|2.5 mg(p.o.)/day for 36 months
12019193|NCT00447915|Dietary Supplement|Calcium and Vitamine D3|Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
12019194|NCT00447902|Drug|tipranavir|
12019195|NCT00447902|Drug|ritonavir|
12019196|NCT00447889|Drug|gadoteric acid|
12019197|NCT00447876|Biological|Botulinum toxin type A|Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia
12019198|NCT00447876|Drug|Placebo|0.9% sodium chloride: 2 ml injected at the root of the plantar fascia
12019199|NCT00447863|Drug|Levonorgestrel/Ethinyl Estradiol|
12019200|NCT00447850|Procedure|endometrial biopsy|
12019201|NCT00447837|Drug|SPRC-AB01|90 mg/3 mL BID, 180 mg/3 mL bid, placebo
12019202|NCT00447824|Procedure|Introduction of better conditions during blood sampling|
12019203|NCT00447811|Drug|MOA-728|
12019204|NCT00447798|Behavioral|Prevention Care Advocate|Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building & strengths based case management
12019205|NCT00447772|Biological|Botulinum toxin type A|Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
12019206|NCT00447759|Drug|Celecoxib|200-400mg daily in divided doses
12019207|NCT00447759|Drug|Diclofenac|prescribed medication taken orally
12019208|NCT00447746|Procedure|D1 or D2 lymphadenectomy for gastric cancer patients|
12019209|NCT00447733|Behavioral|Integrated mental health and substance use treatment|Psychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way.
12019210|NCT00447733|Behavioral|Treatment as usual|Non-standardized psychiatric outpatient treatment
12019211|NCT00447720|Behavioral|PATH|We have chosen to translate two proven prevention programs for delivery to the SMI populations by their case managers. These interventions are the Brief Counseling intervention from the Project Respect program and the Community-Based Outreach Program (CBOM). Together we will translate them into ongoing case management for SMI persons who also abuse substances in the Preventing AIDS through Health Project (PATH). Consistent with other findings regarding HIV infections among the SMI, in our preliminary studies we found that these individuals are at much higher risk within the population of persons being served in Philadelphia.
12019212|NCT00447707|Behavioral|Positive Choice|
12019213|NCT00447694|Drug|Deferasirox|Oral deferasirox 30mg/kg/day once per day for 77 weeks.
12019214|NCT00447681|Drug|ILV-094|
12019215|NCT00447668|Behavioral|Yoga|Yoga for back pain
12019216|NCT00447668|Behavioral|Exercise|exercises for back pain
12019217|NCT00447668|Behavioral|Self-care book recommendations|Self-care book for back pain
12019218|NCT00447655|Behavioral|Self-management and peer support|
12019219|NCT00447642|Drug|LX201|"LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
~LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant is 0.08 inch wide and 0.04 inch in height. The implants are flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded."
12019220|NCT00447642|Other|Placebo|The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
12019221|NCT00447629|Drug|PPM-204|
12019222|NCT00447603|Drug|hydrochlorothiazide (+) losartan potassium|losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
12019223|NCT00447603|Drug|losartan potassium|Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
12019224|NCT00447603|Drug|Placebo for Losartan|
12019225|NCT00447603|Drug|Placebo for Losartan/HCTZ|losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
12019226|NCT00447590|Device|LAP-BAND System|Restriction of food intake
12019227|NCT00447577|Drug|Loteprednol etabonate and tobramycin ophthalmic suspension|Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
12019228|NCT00447577|Drug|Tobramycin and dexamethasone ophthalmic suspension|Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
12019229|NCT00447564|Drug|Probuphine|4 implants
12019230|NCT00447564|Drug|placebo|4 implants
12019231|NCT00447551|Drug|Poly-L-Lactic Acid|Deep dermal injection
12019232|NCT00447525|Biological|REVAXIS®|
12019233|NCT00447525|Biological|DT-Polio®|
12019234|NCT00447512|Drug|ghrelin|acylated ghrelin
12019235|NCT00447499|Drug|Somatuline Autogel (lanreotide acetate)|Injections
12019236|NCT00447499|Behavioral|Home administration|Questionnaire
12019237|NCT00447486|Drug|GW842166|
12019238|NCT00447473|Drug|GM-CSF|GM-CSF will be administered as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) on weeks 2 and 3 each 21 day cycle (total of 14 days).
12019239|NCT00447473|Drug|Ketoconazole|Ketoconazole will be administered daily at a dose of 400 mg po tid (either 1 hour before or 2 hours after meals), ascorbic acid 250 mg po tid (given with ketoconazole) and replacement doses of hydrocortisone (20 mg po in the morning and 10 mg po in the evening).
12019240|NCT00447473|Drug|Mitoxantrone|Mitoxantrone will be given at dose of 12 mg/m2 every 3 weeks, up to a maximum cumulative dose of 140 mg/m2
12019241|NCT00447460|Procedure|Mesenchymal stem cell (MSC)|
12019242|NCT00447434|Drug|Natto extract (Nattokinase)|
12019243|NCT00447421|Drug|pemetrexed|"Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
~Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles"
12019244|NCT00447421|Drug|cisplatin|Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
12019245|NCT00447421|Radiation|radiation|Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4
12019246|NCT00447408|Behavioral|Standard hemodialysis dietary instruction|Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
12019358|NCT00446472|Drug|Regranex®|Regranex gel will be used for a total of 16 weeks
12019247|NCT00447408|Behavioral|Behavioral counseling plus PDA-based self-monitoring of diet|Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments. In addition they receive behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.
12019248|NCT00447382|Drug|insulin detemir|NN304 injected s.c. (under the skin). Given as basal insulin.
12019249|NCT00447382|Drug|insulin aspart|Injected s.c. (under the skin). Given as bolus insulin.
12019250|NCT00447382|Drug|insulin detemir|NN729 injected s.c. (under the skin). Given as basal insulin
12019251|NCT00447369|Drug|Pregabalin|
12019252|NCT00447369|Drug|sodium valproate|
12019253|NCT00447356|Drug|recombinant interferon alfa|
12019254|NCT00447343|Procedure|Decompressive cervical spine surgery|"Treatment group (25 patients) will undergo decompressive anterior cervical spine surgery
~Healthy volunteers will ONLY undergo two scans 6 months apart."
12019255|NCT00447343|Procedure|fMRI and MRS scan|A scan pre-op and 6 months post-op.
12019256|NCT00447330|Drug|capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin)|"Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
12019257|NCT00447317|Behavioral|BalanceWise-PD|Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
12019258|NCT00447317|Behavioral|Attention control|Standard peritoneal dialysis dietary education
12019259|NCT00447304|Drug|moxifloxacin|
12019260|NCT00447304|Procedure|cholecystectomy|
12019261|NCT00447291|Drug|Supplement: Omega-3 Fish Oil|
12019262|NCT00447291|Behavioral|Multi-Disciplinary Nutrition & Exercise program|
12019263|NCT00447278|Drug|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
12019264|NCT00447278|Drug|Other standard therapy for ADHD|Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
12019265|NCT00447265|Drug|Etanercept|1.) Immune suppressant. 2.) Tumor necrosis factor (TNF) inhibitor.
12019266|NCT00447265|Drug|Lupus Treatment- Standard of Care|Individualized standard of care treatment for lupus with corticosteroids and with mycophenolate mofetil (MMF), mycophenolic acid, or azathioprine (AZA)
12019267|NCT00447265|Drug|Placebo|
12019268|NCT00447239|Procedure|glucontrol (insulin therapy)|
12019269|NCT00447226|Drug|Oral lapatinib tablets or placebo tablets|Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progression. Subjects who maintain stable disease will be randomized in a 1:1 ratio to enter stage 2 of the study and receive double blind therapy of either lapatinib 1500 mg/day orally or placebo. Subjects who progress on placebo will have the option to receive lapatinib 1500 mg/day orally until further progression. Those who progress on lapatinib will be withdrawn from the study.
12019270|NCT00447213|Drug|Insulin glargine|Patient specific, injected, daily, 24 weeks
12019271|NCT00447213|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals,12 weeks
12019272|NCT00447213|Drug|Injectable Insulin|Patient specific dose,injected, before meals, 12 weeks
12019273|NCT00447200|Procedure|Esophagus Doppler monitoring|
12019274|NCT00447200|Procedure|Fluid optimization|
12019275|NCT00447187|Drug|LX201|"LX201 is a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
~LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant was 0.08 inch wide and 0.04 inch in height. The implants were flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded."
12019276|NCT00447187|Other|Placebo|The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
12019277|NCT00447174|Behavioral|Dyadic treatment for parental bereavement|
12019278|NCT00447161|Drug|Bacillus Clausii Multi ATB Resist|Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
12019279|NCT00447161|Drug|Placebo|Matched placebo
12019280|NCT00447148|Procedure|3-dimensional coronary angiography|3-dimensional coronary angiography
12019281|NCT00447122|Drug|gemcitabine and Lapatinib|
12019282|NCT00447109|Device|Closed system suction|
12019283|NCT00447096|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Repetitive transcranial magnetic stimulation (rTMS).
12019284|NCT00447083|Device|UVB|UVB exposure by a tanning bed
12019285|NCT00447083|Procedure|Non-UVB|Non-UVB exposure by a tanning bed
12019286|NCT00447070|Drug|ATAZANAVIR|
12019287|NCT00447057|Drug|Pemetrexed|500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity
12019288|NCT00447057|Drug|Erlotinib|150 mg given orally (po), daily (QD), starting on the first day of the first cycle
12019289|NCT00447057|Drug|Pemetrexed|500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
12019290|NCT00447057|Drug|Erlotinib|150 mg given po, QD, starting on the first day of the first cycle
12019291|NCT00447044|Behavioral|Resistance Exercise|Subjects will lift weights with their legs.
12019292|NCT00447044|Dietary Supplement|diet orange soda|Subjects drink diet orange soda 3x day for 2 days.
12019293|NCT00447044|Dietary Supplement|essential amino acids|Subjects drink 15 grams of EAA mixed into diet orange soda 3x day for 2 days.
12019294|NCT00447031|Drug|intravitreal bevacizumab and triamcinolone acetonide|
12019295|NCT00447018|Drug|20% mannitol|
12019296|NCT00447018|Drug|7.45% hypertonic saline solution|
12019297|NCT00447005|Drug|Axitinib (AG-013736)|AG-013736 5mg twice daily [BID]
12019359|NCT00446472|Drug|Hydrogel|Placebo hydrogel will be applied for 16 weeks
12019360|NCT00446459|Drug|mycophenolate mofetil (CellCept)|500mg - 1,000mg, taken PO, twice daily.
12019298|NCT00446992|Drug|Olanzapine|16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
12019299|NCT00446979|Drug|Placebo gel|HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks
12019300|NCT00446979|Drug|UC 781|UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
12019301|NCT00446966|Drug|Omega Three Polyunsaturated fatty acids|2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.
12019302|NCT00446953|Drug|betamethasone|2x12 mg betamethazone c-section at 38 weeks
12019303|NCT00446953|Other|placebo|c-section at 39 weeks
12019304|NCT00446940|Drug|rosuvastatin|
12019305|NCT00446940|Drug|atorvastatin|
12019306|NCT00446914|Behavioral|Systems Change (High Blood Pressure Strategy)|
12019307|NCT00446901|Dietary Supplement|Selenium|Selenized yeast, 300 ug/day
12019308|NCT00446888|Behavioral|Standardized Meals for Diet Stabilization|Subjects will eat prepared meals for 3 days prior to their study; or they will document their dietary intake over this period.
12019309|NCT00446888|Dietary Supplement|Forticare|400 ml of commercially-available nutritional supplement.
12019310|NCT00446888|Dietary Supplement|Product 4808|400 ml Forticare, to which has been added extra protein and the amino acid leucine.
12019311|NCT00446875|Other|Administration of oral Sucrose|Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
12019312|NCT00446875|Other|Administration of oral Placebo|Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
12019313|NCT00446862|Drug|enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers|10 mg by mouth every day; 25 mg by mouth every day
12019314|NCT00446849|Drug|MMX Mesalamine|MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).
12019315|NCT00446836|Drug|Paclitaxel polyglumex (Xyotax)|biologically enhanced chemotherapeutic
12019316|NCT00446823|Device|XCell cellulose wound dressing|
12019317|NCT00446823|Device|Impregnated gauze dressing|
12019318|NCT00446810|Drug|Benfotiamine|
12019319|NCT00446810|Drug|Placebo|
12019320|NCT00446797|Drug|Non-selective NSAIDS|Non-selective NSAIDs administered at usual (standard) doses.
12019321|NCT00446797|Drug|Celecoxib|celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
12019322|NCT00446784|Drug|CE-224,535|
12019323|NCT00446784|Drug|Methotrexate|
12019324|NCT00446771|Drug|Mannitol|
12019325|NCT00446758|Dietary Supplement|Zinc|zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.
12019326|NCT00446732|Device|UroSshield|Attachment of the UroShield device to the external part of the urinary catheter
12019327|NCT00446719|Drug|Rellidep|2000 mg P.O. daily for 8 weeks
12019328|NCT00446693|Device|EndoFast Reliant™ system for Pelvic Organ Prolapse repair|The EndoFast Reliant™ system is a new concept of reinforcing the vaginal wall with proprietary mesh and soft-tissue Fasteners in a minimally-invasive procedure.
12019329|NCT00446680|Drug|Mannitol|400mg BD for 6 months followed by a 6 month open label period
12019330|NCT00446680|Drug|placebo|placebo BD for 6 months
12019331|NCT00446667|Drug|mannitol|400mg BD for 2 days
12019332|NCT00446654|Drug|CGC-11047|16.5 mg (3.3%) subconjunctival injection
12019333|NCT00446641|Drug|Cilostazol|cilostazol 100mg twice a day for 4 weeks
12019334|NCT00446641|Drug|placebo|placebo 1 tablet twice a day matching for cilostazol
12019335|NCT00446628|Behavioral|behaviors reducing spread of influenza|Non-pharmaceutical interventions for flu prevention
12019336|NCT00446615|Behavioral|computer decision support tool|
12019337|NCT00446615|Behavioral|audit and feedback|
12019338|NCT00446615|Behavioral|group learning session|
12019339|NCT00446602|Drug|Epoetin alfa|Type=exact, unit=units, number=80,000, form=solution for injection, route=subcutaneous use, once every week or once every 2 weeks.
12019340|NCT00446589|Drug|ibandronate|iv 1mg ibandronate monthly for one year
12019341|NCT00446589|Drug|teriparatide|sc injection using a pen like device during every hemodialysis session (thrice a week)
12019342|NCT00446576|Drug|Epoetin Alfa|
12019343|NCT00446563|Drug|Valsartan|160 mg film coated tablets taken orally once daily in the morning.
12019344|NCT00446563|Drug|Amlodipine|5 mg or 10 mg tablets taken orally once daily in the morning.
12019345|NCT00446563|Drug|Hydrochlorothiazide|12.5 mg or 25 mg tablets taken orally once daily in the morning.
12019346|NCT00446563|Drug|Losartan|100 mg tablets taken orally once daily in the morning.
12019347|NCT00446550|Drug|afegostat tartrate|
12019348|NCT00446537|Procedure|Methylphenidate|
12019349|NCT00446524|Drug|Valsartan + Amlodipine besilate|During the run-in period, either Valsartan 80 mg or Amlodipine 5 mg tablet was given once daily. Throughout the Valsartan + Amlodipine treatment period, a Valsartan + Amlodipine tablet 80/5 mg was given once daily at around 8:00 AM in the morning.
12019350|NCT00446511|Drug|Valsartan|Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
12019351|NCT00446511|Drug|Enalapril|Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
12019352|NCT00446511|Drug|placebo matched to enalapril|Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
12019353|NCT00446511|Drug|placebo matched to valsartan|placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
12019354|NCT00446498|Device|CPAP and Non Invasive Ventilation|
12019355|NCT00446485|Drug|Ginkgo biloba standardized extract 24/6|tablets, 120 mg/day (60 mg two times daily) during 6 months
12019356|NCT00446485|Drug|Ginkgo Biloba standardized extract 24/6|tablets, 60 mg/day during 6 months
12019357|NCT00446485|Drug|placebo|placebo during 6 months
12019361|NCT00446446|Drug|Panitumumab|Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.
12019362|NCT00446433|Drug|CC-5013|
12019363|NCT00446420|Drug|Propofol, midazolam, fentanyl|All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
12019364|NCT00446407|Other|Collaborative Stepped Care Intervention|Psychoeducation, interpersonal therapy, fluoxetine (20-40 mg/d), adherence management
12019365|NCT00446407|Other|Enhanced Usual Care|Screening plus Antidepressants based on practice guidelines
12019366|NCT00446394|Behavioral|Resources and Activities for Life Long Independence (RALLI)|Strengthening exercises, encouragement to walk daily, pedometer reading, health promotion information for 1.5 hours weekly for 9 weeks
12019367|NCT00446394|Behavioral|Social Walking program (SW)|Group support for walking, pedometer reading, 1 hour weekly for 9 weeks
12019368|NCT00446381|Drug|Macugen (pegaptanib)|Pegaptanib 0.3 mg by intravitreal injection once pre-operatively
12019369|NCT00446381|Drug|Macugen (Pegaptanib)|Pegaptanib 0.3 mg by intravitreal injection once pre-operatively.
12019370|NCT00446368|Drug|RAD001|Participant will take RAD001 (Everolimus) 10mg by mouth once a day.
12019371|NCT00446342|Drug|SNS-032 Injection|"Stage 1: Escalating doses of SNS-032 on days 1, 8 and 15 per 28 day cycle
~Stage 2: Same as stage 1 except SNS-032 administered at the maximum tolerated dose established in stage 1"
12019372|NCT00446329|Drug|cinacalcet|Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.
12019373|NCT00446316|Drug|Antacids (Mg-Al-based)|the antacid (Maximum Strength Maalox®Max® Antacid/Anti-gas) at a dose level of 20 mL (equivalent to 1600 mg aluminum hydroxide and 1600 mg magnesium hydroxide).
12019374|NCT00446316|Drug|Imatimib Mesylate (Gleevec®)|Gleevec® will be administered at a dose of 400 mg. Half of the subjects will receive Gleevec® and antacid on day 15 and Gleevec® alone on day 1. The other half will be treated in reverse order, i.e., they will receive the combination of Gleevec® and antacid on day 1, and Gleevec® alone on day 15. The antacids will be administered 15 minutes before the Gleevec® dose.
12019375|NCT00446303|Drug|Azacitidine|"Azacitidine 60mg/m2 /d for 5 days every 28 days, for 24 months (parallel study to the ongoing NMDSG study.
~Extension of maintenance in responders after 24 courses until relapse or death."
12019376|NCT00446290|Drug|Docetaxel, Capecitabine and Oxaliplatin|
12019377|NCT00446277|Procedure|cataract surgery|
12019378|NCT00446264|Procedure|islet transplantation|Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
12019379|NCT00446264|Drug|daclizumab - sirolimus - tacrolimus|Immunosuppressive consisted of Tacrolimus, target through level at 3-6 ng/ml, Sirolimus, target through level at 12-15 ng/ml for three months and at 7-10 ng/ml thereafter. A five-dose induction course of Daclizumab 1mg/Kg was administered biweekly beginning one hour prior to the first infusion
12019380|NCT00446251|Drug|Rituximab|Rituximab dose is 1,000 mg given as an IV infusion every two weeks for 2 doses (days 1 and 15).
12019381|NCT00446251|Drug|Mycophenolate mofetil (MMF)|Cellcept is continued from prior study, taken 500 - 1,000 mg BID, P.O.
12019382|NCT00446238|Behavioral|Cognitive Behavioral Therapy|CBT enhanced with physical illness narrative, family education, and social skills components.
12019383|NCT00446238|Behavioral|Standard of Community Care Treatment|Treatment as usual for depression and related symptoms provided within the community.
12019384|NCT00446225|Drug|Erlotinib (Tarceva)|150 mg/day
12019385|NCT00446225|Drug|Carboplatin // Gemcitabine // Docetaxel //Cisplatin|Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2); Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8); Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5)
12019386|NCT00446212|Drug|Propofol|target controlled infusion of propofol
12019387|NCT00446212|Drug|desflurane|Anaesthetic maintenance with desflurane
12019388|NCT00446199|Drug|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
12019389|NCT00446199|Drug|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
12019390|NCT00446199|Drug|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
12019391|NCT00446199|Drug|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
12019392|NCT00446186|Drug|MK0476, montelukast sodium / Duration of Treatment: 2 Weeks|
12019393|NCT00446186|Drug|Comparator: placebo / Duration of Treatment: 2 Weeks|
12019394|NCT00446173|Drug|Busulfan|130 mg/m^2 IV Daily Over 3 Hours x 4 Days
12019395|NCT00446173|Drug|Cyclophosphamide|60 mg/kg IV Daily Over 4 Hours x 2 Days
12019396|NCT00446173|Drug|G-CSF|10 mcg/kg Subcutaneously Once Daily
12019397|NCT00446173|Drug|GM-CSF|250 mcg/kg Subcutaneously Once Daily
12019398|NCT00446147|Drug|Pyridoxine|100mg BID/daily, Per oral
12019399|NCT00446147|Drug|Placebo|placebo 100mg BID/daily, Per oral
12019400|NCT00446134|Drug|Taribavirin|Oral (200 mg) Tablet: 20mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
12019401|NCT00446134|Drug|Taribavirin|Oral (200 mg) Tablet: 25mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
12019402|NCT00446134|Drug|Taribavirin|Oral (200mg)Tablet: 30mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
12019446|NCT00445861|Biological|Treatment level 2|Patients receive cetuximab, cisplatin, and radiotherapy as in treatment level 1. Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11.
12019403|NCT00446134|Drug|Ribavirin|Oral (200mg)Tablet: 800 mg/day, 1000 mg/day, 1200 mg/day, or 1400 mg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
12019404|NCT00446095|Drug|fostamatinib|200 mg PO BID
12019405|NCT00446082|Drug|Pasireotide|
12019406|NCT00446069|Drug|Morphine Sulphate|Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks
12019407|NCT00446056|Drug|MK0476, montelukast sodium / Duration of Treatment: 4 Weeks|
12019408|NCT00446056|Drug|Comparator: ketotifen / Duration of Treatment: 4 Weeks|
12019409|NCT00446043|Drug|Adapalene/Benzoyl Peroxide|
12019410|NCT00446030|Drug|Docetaxel|"75 mg/m^2 administered IV on Day 1 for Cycles 1-6
~All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administration. If a participant had not taken their oral dexamethasone the evening prior to receiving docetaxel, the dose of the pre-docetaxel infusion of dexamethasone was increased from 10 mg IV to 15 mg IV. A Dexamethasone 8 mg equivalent may have been used (dexamethasone 8 mg = methylprednisolone 40 mg = prednisone 50 mg = prednisolone 50 mg)."
12019411|NCT00446030|Drug|Doxorubicin|50 mg/m^2 administered IV on Day 1 for Cycles 1-6
12019412|NCT00446030|Drug|Carboplatin|6 mg/mL/min (target area under the curve [AUC] dose) administered IV on Day 1 for Cycles 1-6
12019413|NCT00446030|Drug|Cyclophosphamide|500 mg/m^2 administered IV on Day 1 for Cycles 1-6
12019414|NCT00446030|Drug|Trastuzumab|A single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy
12019415|NCT00446030|Drug|Bevacizumab|15 mg/kg administered IV on Day 1 for Cycles 1-6, and for maintenance therapy
12019416|NCT00446017|Drug|adrenaline|
12019417|NCT00446017|Drug|milrinone|
12019418|NCT00446004|Drug|Imatinib Mesylate|Dosage form: tablets Dosage: 400 mg Frequency & duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)
12019419|NCT00446004|Drug|Omeprazole|Dosage form: capsules Dosage: 40 mg Frequency: On an 18-day schedule, once daily day 10 through day 16 (for Arm A); or once daily day -4 through day 1 (for Arm B)
12019420|NCT00445978|Drug|6R-BH4 (sapropterin dihydrochloride)|Subjects will receive oral, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) of 6R-BH4 during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day. Subjects may continue in an optional extension phase at the highest tolerated dose for up to a total of 2 years.
12019421|NCT00445965|Genetic|DNA analysis|
12019422|NCT00445965|Other|immunologic technique|
12019423|NCT00445965|Other|pharmacological study|
12019424|NCT00445965|Radiation|iodine I 131 monoclonal antibody 3F8|
12019425|NCT00445965|Radiation|131I-3F8|Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
12019426|NCT00445952|Other|clinical observation|
12019427|NCT00445952|Procedure|management of therapy complications|
12019428|NCT00445939|Biological|adalimumab|160 mg at Week 0, 80 mg at Week 2
12019429|NCT00445939|Biological|adalimumab|80 mg at Week 0, 40 mg at Week 2
12019430|NCT00445939|Biological|placebo|Placebo at Week 0 and Week 2
12019431|NCT00445926|Device|deep TMS H-coil|
12019432|NCT00445913|Biological|Diabetes-suppressive dendritic cell vaccine|The dendritic cells will be treated ex vivo with the antisense oligonucleotides and cryopreserved in aliquots for subsequent intradermal administration into sites closest to the physical location of the pancreas inside the body. Physiologic, biologic and immunologic responses to the dendritic cell vaccine will be evaluated over the period of the trial. The first group of volunteers will receive autologous dendritic cells without any ex vivo treatment (7/15) and the second group will be administered iDC (8/15). If there is no evidence of toxicity or adverse events associated with the dendritic cell vaccine, and only upon FDA and IRB approval we will initiate a new study comparing efficacy of control DC and iDC in improving glycemia and reversing autoimmunity in new-onset patients.
12019433|NCT00445913|Biological|control dendritic cells|The dendritic cells will be treated ex vivo with vehicle and cryopreserved in aliquots for subsequent intradermal administration into sites closest to the physical location of the pancreas inside the body. Physiologic, biologic and immunologic responses to these control dendritic cells will be evaluated over the period of the trial. The first group of volunteers will receive autologous dendritic cells without any ex vivo treatment (7/15) and the second group will be administered iDC (8/15). If there is no evidence of toxicity or adverse events associated with the dendritic cell vaccine, and only upon FDA and IRB approval we will initiate a new study comparing efficacy of control DC and iDC in improving glycemia and reversing autoimmunity in new-onset patients.
12019434|NCT00445900|Drug|cyclophosphamide|
12019435|NCT00445900|Drug|prednisone|
12019436|NCT00445900|Drug|thalidomide|
12019437|NCT00445900|Other|immunohistochemistry staining method|
12019438|NCT00445900|Other|laboratory biomarker analysis|
12019439|NCT00445900|Procedure|biopsy|
12019440|NCT00445887|Other|Laboratory Biomarker Analysis|Correlative studies
12019441|NCT00445887|Drug|Levonorgestrel|Given orally
12019442|NCT00445887|Other|Placebo|Given orally
12019443|NCT00445874|Drug|Ketotifen with a Contact Lens (no generic name)|
12019444|NCT00445861|Biological|cetuximab + docetaxel + cisplatin|Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses.
12019445|NCT00445861|Biological|Treatment level 1|Treatment level 1: Patients receive cetuximab IV over 1 hour once weekly, cisplatin IV over 1 hour once weekly, and undergo radiotherapy once daily, 5 days a week, in weeks 7-11.
12019447|NCT00445861|Procedure|conventional surgery|Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy, patients undergo surgery.
12019449|NCT00445848|Drug|erlotinib hydrochloride|
12019450|NCT00445835|Other|Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds|A strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis
12019451|NCT00445835|Other|Conservative arm|Conservative medical approach
12019452|NCT00445796|Drug|Artesunate|
12019453|NCT00445796|Drug|Amodiaquine|
12019454|NCT00445783|Genetic|gene expression analysis|
12019455|NCT00445783|Genetic|mutation analysis|
12019456|NCT00445783|Other|immunohistochemistry staining method|
12019457|NCT00445783|Other|laboratory biomarker analysis|
12019458|NCT00445783|Procedure|examination|
12019459|NCT00445783|Procedure|mutation carrier screening|
12019460|NCT00445783|Procedure|study of high risk factors|
12019461|NCT00445770|Drug|Etanercept|10 mg twice weekly, subcutaneous injection for 52 weeks
12019462|NCT00445770|Drug|Etanercept|25 mg, twice weekly, subcutaneous injection for 52 weeks
12019463|NCT00445770|Drug|Methotrexate|up to 8 mg per week, oral dosing for 52 weeks
12019464|NCT00445757|Procedure|conventional surgery|Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.
12019465|NCT00445757|Radiation|stereotactic radiosurgery|Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached.
12019466|NCT00445744|Drug|cyclophosphamide|Given IV
12019467|NCT00445744|Drug|busulfan|Given IV
12019468|NCT00445744|Drug|tacrolimus|Given IV or PO
12019469|NCT00445744|Drug|methotrexate|Given IV
12019470|NCT00445744|Genetic|cytogenetic analysis|Correlative studies
12019471|NCT00445744|Other|flow cytometry|Correlative studies
12019472|NCT00445744|Other|pharmacological study|Correlative studies
12019473|NCT00445744|Other|pharmacogenomic studies|Correlative studies
12019474|NCT00445744|Procedure|peripheral blood stem cell transplantation|Undergo PBPC transplantation
12019475|NCT00445744|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic transplantation
12019476|NCT00445731|Behavioral|exercise intervention|
12019477|NCT00445731|Procedure|management of therapy complications|
12019478|NCT00445731|Procedure|observation|
12019479|NCT00445718|Procedure|computed tomography|
12019480|NCT00445718|Procedure|3-Tesla magnetic resonance imaging|
12019481|NCT00445718|Procedure|Abdominal Sonogram|Sonogram of the abdomen area
12019482|NCT00445705|Drug|placebo|Part A: Placebo every 12 hours for 4 weeks
12019483|NCT00445705|Drug|AGN 203818|Part A: AGN 203818 3 mg every 12 hours for 4 weeks
12019484|NCT00445705|Drug|AGN 203818|Part A: AGN 203818 20 mg every 12 hours for 4 weeks
12019485|NCT00445705|Drug|AGN 203818|Part A: AGN 203818 60 mg every 12 hours for 4 weeks
12019486|NCT00445692|Drug|Clarithromycin|Given Orally (PO)
12019487|NCT00445692|Drug|Dexamethasone|Given PO
12019488|NCT00445692|Drug|Lenalidomide|Given Orally (PO)
12019489|NCT00445679|Drug|DVS SR|Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
12019490|NCT00445679|Drug|Paroxetine|20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
12019491|NCT00445614|Behavioral|Effects of trout on CVD risk markers and plasma proteome|
12019492|NCT00445601|Drug|gemcitabine hydrochloride|Given intravesically
12019493|NCT00445601|Other|placebo|Given intravesically
12019494|NCT00445588|Drug|erlotinib hydrochloride|150mg Given orally once daily
12019495|NCT00445588|Drug|sorafenib tosylate|400mg Given orally twice daily
12019496|NCT00445588|Other|pharmacological study|Correlative studies
12019497|NCT00445575|Drug|risedronate|During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
12019498|NCT00445575|Drug|placebo|placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
12019499|NCT00445575|Drug|risedronate|During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
12019500|NCT00445575|Drug|placebo|placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
12019501|NCT00445562|Other|biologic sample preservation procedure|
12019502|NCT00445562|Other|informational intervention|
12019503|NCT00445549|Drug|Vandetanib|300 mg daily dose, 28 day cycle
12019504|NCT00445523|Biological|TroVax® (Immunological Vaccine Therapy)|16 Intramuscular injections of TroVax® over 47 weeks
12019505|NCT00445523|Drug|Interferon-alpha|36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)
12019506|NCT00445510|Drug|GSK256066|
12019507|NCT00445497|Drug|amoxicillin-clavulanate potassium|
12019508|NCT00445497|Drug|ciprofloxacin|
12019509|NCT00445497|Procedure|psychosocial assessment and care|
12019510|NCT00445497|Procedure|quality-of-life assessment|
12019511|NCT00445484|Biological|pneumococcal polyvalent vaccine|Given intramuscularly
12019512|NCT00445484|Drug|lenalidomide|Given orally
12019513|NCT00445471|Behavioral|Mifne Approach to PDD|
12019514|NCT00445471|Behavioral|Treatment as usual|
12019515|NCT00445458|Drug|HKI-272|
12019516|NCT00445458|Drug|Paclitaxel|
12019517|NCT00445445|Other|physiologic testing|Urine samples will be assessed for levels of bisphenol-A
12019566|NCT00445055|Drug|Droperidol|Intravenous injection
12019614|NCT00444652|Drug|Enoxaparin|injection of enoxaparin a few time
12019851|NCT00019968|Drug|tumor necrosis factor|
12019518|NCT00445445|Other|screening questionnaire administration|Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
12019519|NCT00445445|Procedure|breast imaging study|Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
12019520|NCT00445445|Procedure|radiomammography|Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
12019521|NCT00445445|Procedure|study of high risk factors|"Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
~Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis."
12019522|NCT00445432|Biological|adalimumab|Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)
12019523|NCT00445432|Other|Placebo|Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)
12019524|NCT00445419|Biological|PEV2A PEV2B|
12019525|NCT00445406|Drug|bevacizumab + doxorubin hydrochloride liposme|Patients receive bevacizumab IV over 30-90 minutes and doxorubicin hydrochloride liposome IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for up to 6 courses
12019526|NCT00445406|Drug|Bevacizumab|Patients then receive bevacizumab alone IV over 30-90 minutes on days 1 and 15. Courses with bevacizumab repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
12019527|NCT00445354|Drug|cinnamon|
12019528|NCT00445341|Drug|Flavopiridol|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
12019529|NCT00445328|Drug|Dalteparin (Fragmin)|Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
12019530|NCT00445328|Drug|Unfractionated heparin|Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
12019531|NCT00445315|Drug|PF-00868554|300 mg BID
12019532|NCT00445315|Drug|PF-00868554|450 mg BID
12019533|NCT00445315|Drug|PF-00868554|100 mg BID
12019534|NCT00445315|Drug|PF-00868554|300 mg TID
12019535|NCT00445315|Drug|Placebo|Placebo
12019536|NCT00445302|Drug|plerixafor|Single dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection
12019537|NCT00445289|Device|SmartCare/PS|
12019538|NCT00445276|Drug|Diacerein|
12019539|NCT00445263|Drug|TIROFIBAN|intravenous infusion
12019540|NCT00445263|Procedure|CORONAROGRAPHY|standard procedure of coronarography
12019541|NCT00445250|Drug|Calcipotriol|
12019542|NCT00445237|Device|H1 and H2 deep TMS coils|
12019543|NCT00445224|Other|Hip Progressive Resistive Exercise|Hip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening hip abduction ad external rotation musculature.
12019544|NCT00445224|Other|Quad Progressive Resistive Exercises|Quad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics.
12019545|NCT00445211|Drug|Heparin|Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).
12019546|NCT00445211|Other|Without Heparin|Intra-Aortic balloon Pump (IABP) without Heparin.
12019547|NCT00445198|Drug|ABT-263|"Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.
~- 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study.
~Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.
~- 40 patients with SCLC"
12019548|NCT00445185|Biological|Henogen HB vaccine|Month 12, 24 and 36
12019549|NCT00445185|Biological|Fendrix vaccine|Month 12, 24 and 36
12019550|NCT00445172|Drug|E0302 (mecobalamin)|Intramuscular injection, mecobalamin twice a week.
12019551|NCT00445159|Drug|UT-15C SR (treprostinil diethanolamine) 1mg oral tablets|
12019552|NCT00445146|Drug|EVG|Elvitegravir (EVG) tablet administered orally once daily with food
12019553|NCT00445146|Drug|RTV|Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
12019554|NCT00445146|Drug|ARV regimen|The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).
12019555|NCT00445133|Device|Magnetic Sleep Pad|
12019556|NCT00445120|Drug|Lactobacillus Rhamnosus GG|patients are treated with oral Lactobacillus Rhamnosus GG once daily for six months
12019557|NCT00445120|Drug|placebo (sugar)|Placebo will be administered to patients once daily for six months
12019558|NCT00445107|Drug|MK0476, montelukast sodium / Duration of Treatment: 8 Weeks|
12019559|NCT00445094|Drug|MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days|
12019560|NCT00445094|Drug|Comparator: amikacin / Duration of Treatment: 3 Days|
12019561|NCT00445094|Drug|Comparator: tazocin / Duration of Treatment: 3 Days|
12019562|NCT00445094|Drug|Comparator: vancomycin / Duration of Treatment: 3 Days|
12019567|NCT00445042|Drug|Sorafenib|The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the protocol, providing no dose limiting toxicity (Grade 3 or 4) is observed.
12019568|NCT00445016|Procedure|peripheral regional anesthesia|evaluation and description of adverse effects
12019569|NCT00445003|Drug|Ranibizumab|Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks
12019570|NCT00445003|Drug|Triamcinolone Acetonide|Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
12019571|NCT00445003|Behavioral|Sham injection|Sham injection at baseline and 4 weeks
12019572|NCT00445003|Procedure|Focal/grid laser|Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
12019573|NCT00444990|Device|Magnetic Flex Pad|
12019574|NCT00444977|Behavioral|Case-management linkage intervention|dental care
12019575|NCT00444964|Drug|Nutropin AQ|
12019576|NCT00444951|Biological|Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine|0.5 mL, Intramuscular
12019577|NCT00444951|Biological|Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine|0.5 mL, Subcutaneous
12019578|NCT00444951|Biological|Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine|0.5 mL, Intramuscular
12019579|NCT00444938|Device|H1 -coil TMS device|
12019580|NCT00444925|Drug|fesoterodine fumarate|4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
12019581|NCT00444925|Drug|placebo|once daily (OD)for 12 weeks
12019582|NCT00444925|Drug|tolterodine tartrate|4 mg once daily (OD) for 12 weeks
12019583|NCT00444912|Drug|G-CSF plus plerixafor|Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
12019584|NCT00444912|Drug|G-CSF plus plerixafor|Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥5*10^6 CD34+ cells/kg were collected.
12019585|NCT00444912|Biological|rituximab|Participants were given a weekly dose of rituximab 375mg/m2 by intravenous infusion for 1 week prior to and continuing until 2 weeks after the first dose of G-CSF.
12019586|NCT00444899|Behavioral|Intensive treatment|Subjects will be followed by the dietician in combination with his/her endocrinologist. Diet, physical activity, smoking cessation and drug prescriptions will be used to treat subjects.
12019587|NCT00444899|Other|Normal follow-up|Subject will continue to be followed by their endocrinologist and general practitioner as they already do.
12019588|NCT00444886|Drug|Botulinum Toxin Type A injection (BOTOX)|Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.
12019589|NCT00444886|Drug|Botulinum Toxin Type A injection (BOTOX)|Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.
12019590|NCT00444873|Drug|lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval|Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
12019591|NCT00444860|Biological|Zoster Vaccine, Live, (Oka-Merck)|A single dose of 0.65 ml of Zostavax injection was given to each study subject
12019592|NCT00444847|Device|Hyperbaric chamber|
12019593|NCT00444834|Drug|Carvedilol|50 mg
12019594|NCT00444821|Device|AneuRx AAA stent graft / Talent AAA stent graft|Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
12019595|NCT00444808|Drug|Intranasal calcitonin|
12019596|NCT00444795|Drug|Sunitinib malate|Sunitinib : dosing not pre-determined
12019597|NCT00444795|Drug|Sunitinib malate|Sunitinib : dosing not pre-determined
12019598|NCT00444795|Drug|sunitinib malate|Sunitinib : dosing not pre-determined
12019599|NCT00444782|Biological|GV1001|
12019600|NCT00444769|Drug|GW842166|
12019601|NCT00444756|Procedure|J-tip jet injection of 1% buffered lidocaine|
12019602|NCT00444743|Drug|MM-093|60 mg, administered subcutaneously, weekly
12019603|NCT00444743|Other|Placebo|Placebo
12019604|NCT00444730|Procedure|Radical Prostatectomy|Surgical procedure for prostate cancer.
12019605|NCT00444730|Procedure|InterStim Implantation|surgical placement of the interstim
12019606|NCT00444730|Procedure|Pelvic organ prolapse repair|Surgical pelvic organ prolapse repair
12019607|NCT00444717|Drug|pitavastatin|Pitavastatin (2mg/day) was administered for 12 weeks
12019608|NCT00444704|Drug|PRA-027|
12019609|NCT00444691|Device|ultra-sonography|"o The ultrasonographic evaluation was performed on 38 joints: the 28 joints included in DAS28 (e.g. shoulderx2, elbowx2, wristx2, metacarpo-phalangeal (MCP)x10, proximal inter phalangeal (PIP)x10, kneex2) and also the metatarso-phalangeal (MTPx10). Systematic multiplanar gray-scale (mode B) and Power Doppler examination was carried out with commercially available real-time scanners using multi-frequency linear transducers (7-12 MHz).
~The ultrasonographic evaluation was performed at baseline and 1, 2, 3, and 4 months after baseline."
12019610|NCT00444678|Drug|Cetuximab|500 mg/m2, IV every two weeks
12019611|NCT00444678|Drug|Oxaliplatin|85 mg/m2, IV, q 2 weeks
12019612|NCT00444678|Drug|Capecitabine|2500 mg, po bid x 7 days every two weeks
12019613|NCT00444665|Drug|Travatan-Z|
12019615|NCT00444639|Drug|Triptorelin (Decapeptyl®)|Two injections of 11.25mg given every 12 weeks
12019616|NCT00444626|Device|Dermal Gel Extra (DGE)|Dermal Gel Extra (DGE) Injectable Gel contains hyaluronic acid with lidocaine. DGE was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of DGE to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period.
12019617|NCT00444626|Device|Restylane|Restylane was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of Restylane to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period.
12019618|NCT00444626|Drug|EMLA Cream|EMLA Cream (Eutectic Mixture of Local Anesthetics) is an FDA-approved topical anesthetic comprised of 2.5% each of lidocaine/prilocaine. EMLA Cream was applied in approximately equal amounts prior to all injections of DGE and Restylane.
12019619|NCT00444613|Drug|E0302 (mecobalamin)|Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.
12019620|NCT00444613|Drug|E0302 (mecobalamin)|Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years.
12019621|NCT00444613|Drug|Placebo|Intramuscular injection, placebo twice a week for 3.5 years.
12019622|NCT00444600|Drug|Triamcinolone Acetonide + laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
12019623|NCT00444600|Drug|Ranibizumab + laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
12019624|NCT00444600|Drug|Sham injection + laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
12019625|NCT00444600|Drug|Ranibizumab + deferred laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
12019626|NCT00444587|Drug|Second line chemotherapy|As prescribed
12019627|NCT00444587|Drug|trastuzumab [Herceptin]|6mg/kg iv every 3 weeks
12019628|NCT00444574|Drug|Methylphenidate Transdermal System|The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
12019629|NCT00444574|Drug|Placebo|The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
12019630|NCT00444574|Drug|Concerta|The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
12019631|NCT00444561|Drug|pramlintide acetate|Clear, colorless, sterile solution for SC administration
12019632|NCT00444548|Drug|[S,S]-Reboxetine|
12019633|NCT00444535|Drug|lapatinib|1500 mg oral lapatinib (once daily)
12019634|NCT00444535|Drug|bevacizumab|10 mg/kg intravenous bevacizumab (every two weeks)
12019635|NCT00444522|Drug|Alprazolam thermal aerosol|
12019636|NCT00444509|Drug|GW685698X|GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
12019637|NCT00444509|Drug|GW685698X containing magnesium stearate|GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
12019638|NCT00444483|Behavioral|Structured diabetes teaching and treatment program|
12019639|NCT00444470|Drug|Tranexamic acid|"Eligible patients who have consented to be in the study and have been randomised to be in Arm A will receive 10 mg/kg of tranexamic acid, and then a continuous infusion of 1 mg/kg/hr of tranexamic acid."
12019640|NCT00444470|Drug|Placebo|"Eligible patients who have consented to be in the study and have been randomised to be in Arm B will receive 10 mg/kg of placebo followed by a continuous infusion of 1 mg/kg/hr of placebo."
12019641|NCT00444457|Biological|13-valent Pneumococcal Conjugate Vaccine|0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
12019642|NCT00444457|Biological|7vPnC|0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
12019643|NCT00444431|Procedure|Pyeloplasty|
12019644|NCT00444418|Drug|Naltrexone|Naltrexone, 100 mg. oral dosage, daily for 12 weeks.
12019645|NCT00444418|Behavioral|Modified Behavioral Self-Control Psychotherapy|Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.
12019646|NCT00444418|Behavioral|Brief Behavioral Compliance Enhancement Therapy|Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
12019647|NCT00444392|Behavioral|Calorie controlled diabetic diet for the control patients|Calorie controlled diabetic diet for the control patients
12019648|NCT00444379|Drug|Lopinavir/ritonavir plus Emtricitabine/Tenofovir versus Efavirenz plus Emtricitabine/Tenofovir|Lopinavir/ritonavir 200/50mg plus Emtricitabine/Tenofovir 200/300mg versus Efavirenz 600mg plus Emtricitabine/Tenofovir 200/300mg
12019649|NCT00444353|Device|DL6049 (injectable poly-L-lactic acid)|
12019650|NCT00444340|Drug|Enbrel (Etanercept)|
12019651|NCT00444314|Drug|Panzem® NCD|NCD suspension, 1500 mg TID daily for 6 week cycles
12019652|NCT00444314|Drug|Sunitinib Malate|Sunitinib Malate, highest tolerated dose (patient's current dose), daily oral administration for 4 weeks, with 2 week break in 6 week cycle
12019653|NCT00444275|Drug|esomeprazole (Nexium®)|"This randomized study was conducted on parallel groups and included two phases:
~One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
~One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed"
12019704|NCT00443898|Drug|Placebo|vehicle (placebo) applied once daily for 24 weeks
12019852|NCT00019890|Drug|dendritic cell-gp100-MART-1 antigen vaccine|
12019654|NCT00444275|Drug|Xolaam®|"This randomized study was conducted on parallel groups and included two phases:
~One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
~One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed"
12019655|NCT00444262|Procedure|hemodynamic optimisation guided using esophageal Doppler|hemodynamic optimisation guided using esophageal Doppler
12019656|NCT00444262|Drug|VOLUVEN and others solute|VOLUVEN and others solute
12019657|NCT00444249|Procedure|White Alcon IOL|Implantation of white Alcon IOL
12019658|NCT00444249|Procedure|Yellow Alcon IOL|Implantation of yellow Alcon IOL
12019659|NCT00444249|Procedure|White Hoya IOL|Implantation of white Hoya IOL
12019660|NCT00444249|Procedure|Yellow Hoya IOL|Implantation of yellow Hoya IOL
12019661|NCT00444236|Drug|Nexium|nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks
12019662|NCT00444236|Drug|Placebo|matching placebo for active drug
12019663|NCT00444223|Procedure|fluorine F 18 FEQA + positron emission tomography|
12019664|NCT00444210|Device|DL6049 (injectable poly-L-lactic acid)|
12019665|NCT00444197|Behavioral|Mentoring and violence prevention curriculum with parental monitoring|
12019666|NCT00444184|Drug|Travoprost/timolol fixed combination, travoprost|
12019667|NCT00444171|Procedure|insulin infusion rate controled by computer algorithm|
12019668|NCT00444171|Procedure|insulin infusion rate guided by in-house glucose management protocol|
12019669|NCT00444158|Drug|MOA-728|
12019670|NCT00444145|Drug|Prevacid|30 mg bid for 3 months
12019671|NCT00444145|Procedure|Esophageal and Laryngeal Biopsies|repeat egd with biopsy after Prevacid 30 mg bid for 3 months
12019672|NCT00444132|Drug|clopidogrel|
12019673|NCT00444106|Drug|Artesunate-mefloquine|
12019674|NCT00444106|Drug|Atovaquone-proguanil|
12019675|NCT00444106|Drug|Artemether-lumefantrine|
12019676|NCT00444093|Drug|Opii normata treatment|"After beginning of diarrhea grade 1:
~5 drops tincture of opium three times a day
~After beginning of diarrhea grade 2:
~Intensive therapy with 15 drops tincture of opium three times a day."
12019677|NCT00444093|Drug|Loperamid Treatment|"All patients who receive as a result of randomisation loperamide
~After beginning of diarrhea grade 1:
~Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day.
~After beginning of diarrhea grade 2:
~Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day."
12019678|NCT00444080|Procedure|Trabeculectomy|"Standard trabeculectomy procedure
~Creation of a fornix or limbal based conjunctival flap in upper quadrants
~Creation of a limbal-based scleral flap extending into clear cornea
~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
~Creation of fistula 1mm x 2mm in size
~Iridectomy
~Suturing the scleral flap
~Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged."
12019679|NCT00444080|Device|Ex-PRESS mini shunt|"Ex-PRESS implantation procedure:
~Creation of a fornix or limbal based conjunctival flap in upper quadrants
~Creation of limbal-based scleral flap extending into clear cornea
~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
~Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus
~Prior to implantation, a thorough mobility check should be performed
~Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
~Withdrawal of introducer
~Tucking plate under the scleral flap, and verification of its position
~Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged."
12019680|NCT00444067|Device|Spinal Sealant|Spinal Sealant System
12019681|NCT00444067|Other|Standard of Care|Standard of Care
12019682|NCT00444054|Behavioral|Very low carbohydrate diet (approximately 20 grams per day)|Very low carbohydrate diet for a duration of four weeks.
12019683|NCT00444041|Drug|Bevacizumab|neoadjuvant therapy prior to elective surgery
12019684|NCT00444028|Drug|inhaled Loxapine 0.625 mg|Single 0.625 mg (lowest) dose of inhaled loxapine
12019685|NCT00444028|Drug|inhaled Loxapine 1.25 mg|Single 1.25 mg (2nd) dose of inhaled loxapine
12019686|NCT00444028|Drug|inhaled Loxapine 2.5 mg|Single 2.5 mg (3rd) dose of inhaled loxapine
12019687|NCT00444028|Drug|inhaled Loxapine 5 mg|Single 5 mg (4th) dose of inhaled loxapine
12019688|NCT00444028|Drug|inhaled Loxapine 10 mg|Single 10 mg (5th) dose of inhaled loxapine
12019689|NCT00444028|Drug|inhaled Placebo (0 mg)|Single placebo dose of inhaled loxapine
12019690|NCT00444015|Drug|Erlotinib in combination with Dasatinib|6 Cycles @ 28 Days
12019691|NCT00443976|Drug|Aurora kinase inhibitor AT9283|The starting dose of AT9283 will be 1.5 mg/m2 given as a 24 hour IV infusion on Days 1 and 8 every three weeks.
12019692|NCT00443963|Drug|Esomeprazole Magnesium|PPI compared to H2RA
12019693|NCT00443950|Drug|Etanercept|
12019694|NCT00443937|Drug|enteric-coated mycophenolate sodium|oral
12019695|NCT00443937|Drug|everolimus|oral
12019696|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
12019697|NCT00443924|Drug|Placebo|One drop of placebo in each eye every 12 hours for three days
12019698|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
12019699|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
12019700|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
12019701|NCT00443898|Drug|terbinafine|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
12019702|NCT00443898|Drug|Placebo|vehicle (placebo) applied once daily for 48 weeks
12019703|NCT00443898|Drug|terbinafine|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
12019705|NCT00443872|Drug|orally disintegrating selegiline (Zelapar)|1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated
12019706|NCT00443846|Biological|RotaTeq®|Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
12019707|NCT00443846|Biological|NeisVac-C®|Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.
12019708|NCT00443820|Drug|terbinafine|Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks
12019709|NCT00443820|Drug|Placebo|Vehicle (placebo) once daily for 48 weeks
12019710|NCT00443820|Drug|terbinafine|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
12019711|NCT00443820|Drug|Placebo|Vehicle (placebo) once daily for 24 weeks
12019712|NCT00443807|Device|On-line EEG monitoring during neurosurgery|Comparison of 2 ways of processing the EEG signal
12019713|NCT00443807|Device|EEGo vs BIS|comparison of two processed EEG monitors.
12019714|NCT00443794|Drug|Thiazides|Capsule (blinded) oral administration once daily for 12 weeks
12019715|NCT00443794|Drug|Ramipril with Thiazide|Capsule (blinded) oral administration 12 weeks
12019716|NCT00443794|Drug|Thiazide plus atenolol|Caspule (blinded) for oral administration once daily for 12 weeks
12019717|NCT00443794|Drug|Ramipril plus atenolol|Capsule ( blinded) for oral administration once daily for 12 weeks
12019718|NCT00443794|Drug|Ramipril plus atenolol plus thiazide|Capsule (blinded) for oral administration once daily for 12 weeeks
12019719|NCT00443794|Drug|POLYCAP|Capsule for Oral Administration once daily for 12 weeks
12019720|NCT00443794|Drug|Thiazide + Ramipril+Atenolol+Aspirin|Capsule (Blinded) for oral administration once daily for 12 weeks
12019721|NCT00443794|Drug|Simvastatin|Capsule (Blinded) for oral administration once daily for 12 weeks
12019722|NCT00443794|Drug|aspirin|capsule (Blinded) for oral administration once daily for 12 weeks
12019723|NCT00443781|Procedure|functional anesthetic discography|Functional Anesthetic Discography (F.A.D.) involves the placement and anchoring of a small catheter into a disc. After placement, functional testing is performed, in which the subject elicits his/her back pain via functional maneuvers or postures. Local anaesthetic is then delivered into the target disc through the catheter and the effect on functional back pain is noted.
12019724|NCT00443781|Procedure|provocative discography|"Provocative discography (PD) has been used as a preoperative diagnostic tool for patients with back pain attributed to degenerative disc disease considering lumbar disc surgery. During PD, a clinically suspected disc is accessed with a needle and injected under pressure with radiopaque contrast dye. The subject rates his/her experience of pain for intensity and whether the pain is exactly the same as (concordant) or different from (not concordant or discordant) typical back pain."
12019725|NCT00443755|Drug|metformin|To minimize side effects the metformin will be initiated at 500 mg twice daily with meals and increased to 1 gm twice daily with meals after two weeks and continue to a total of 3 months of dosing.
12019726|NCT00443755|Drug|pioglitazone|To minimize side effects, the pioglitazone will be initiated at 30 mg daily and increased to 45 mg daily after two weeks, and continue to a total of 3 months of dosing.
12019727|NCT00443755|Drug|Placebo|Placebo tablets matching the metformin and pioglitazone tablets are given in the same regimen as the active drug arm for 3 months.
12019728|NCT00443742|Procedure|Validation|
12019729|NCT00443729|Drug|Comparator: raltegravir|raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
12019730|NCT00443729|Drug|Comparator: placebo|lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
12019731|NCT00443729|Drug|Comparator: lopinavir (+) ritonavir|lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment
12019732|NCT00443729|Drug|Comparator: placebo|raltegravir 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
12019733|NCT00443716|Drug|estrogen|
12019734|NCT00443703|Drug|MK0518 (raltegravir)|MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
12019735|NCT00443703|Drug|Comparator: KALETRA™ (lopinavir (+) ritonavir )|KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.
12019736|NCT00443703|Drug|Comparator: placebo|MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
12019737|NCT00443703|Drug|Comparator: placebo|KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.
12019738|NCT00443690|Drug|rolofylline|rolofylline 30 mg IV QD; 3 days
12019739|NCT00443690|Drug|Comparator: Placebo (unspecified)|rolofylline Pbo 30 mg IV QD; 3 days
12019740|NCT00443677|Drug|COPPEBVCAD vs BEACOPP vs ABVD|
12019741|NCT00443664|Device|EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY|
12019742|NCT00443651|Drug|Rituximab|Rituximab was supplied as a concentrate for IV administration at a concentration of 10 mg/mL in 500 mg (50 mL) single-use vials.
12019743|NCT00443651|Drug|Anti-inflammatory drugs|Each rituximab infusion was preceded by methylprednisolone 100 mg IV. Use of stable doses of oral corticosteroids was permitted (≤ 10 mg of prednisone or equivalent per day) as were stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs).
12019744|NCT00443638|Behavioral|nurse home visitation|Nurse home visitation
12019745|NCT00443625|Drug|SK3530|
12019746|NCT00443612|Drug|Irbesartan/Hydrochlorothiazide|Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg
12019747|NCT00443612|Drug|Irbesartan|Administration of irbesartan 150 mg/day
12019748|NCT00443599|Drug|Insulin|Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
12019749|NCT00443599|Other|Usual Care|Participants receive standard Cardiac ICU care without tight blood glucose control.
12019750|NCT00443586|Behavioral|Developmental Screening|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
12019847|NCT00020202|Drug|FR901228|
12019751|NCT00443586|Behavioral|Screening plus Transportation|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
12019752|NCT00443586|Behavioral|Screening, Transport, Prenatal Visits|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
12019753|NCT00443586|Behavioral|Screen, Transport, Prenatal/Inf Visits|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.
12019754|NCT00443573|Drug|recombinant nematode anticoagulant protein c2 (rNAPc2)|escalating dose administered 2x/week sq.
12019755|NCT00443560|Other|Case controlled analysis of epidural labor analgesia patterns|A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
12019756|NCT00443547|Device|Vectra-T|Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
12019757|NCT00443534|Drug|SU011248|Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol
12019758|NCT00443521|Drug|Triamcinolone Acetonide 4 mg intravitreal injection|
12019759|NCT00443521|Procedure|Panretinal photocoagulation|
12019760|NCT00443508|Drug|adding Certican to therapy|
12019761|NCT00443508|Drug|reducing Tacrolimus|
12019762|NCT00443495|Drug|Chitin microparticles by nasal route|
12019763|NCT00443482|Drug|formoterol|
12019764|NCT00443469|Device|magnetic stimulation|SMS was delivered with a repetitive magnetic stimulator connected to a figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. SMS was performed with the patient lying comfortably in the prone position and a soft pillow supported the lower abdomen. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of 5 pulses delivered at 10 Hz, at an interval of 5 s between each train. As this was a pilot study, each only received 1000 pulses in a single session.
12019765|NCT00443469|Device|Magnetic Stimulation with tilted coil|The placebo arm consisted of 'sham' SMS delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. As this coil type allows maximum magnetic flux at the center of the intersection, we believe minimum or no stimulation was effected at the edge of the coil in contact with the patient. Stimulation parameters and duration were unchanged in this arm.
12019766|NCT00443456|Drug|Amlodipine|Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
12019767|NCT00443430|Drug|methotrexate|Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone
12019768|NCT00443430|Drug|methotrexate - etanercept - prednisolone arm|methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks.
12019769|NCT00443417|Drug|SK-PC-B70M|dosage, frequency
12019770|NCT00443404|Procedure|perioperative epidural catheter|Perioperative epidural catheter in groups 1-4. Pre- and postoperative epidural analgesia in group 1. Preoperative IV PCA Fentanyl and postoperative epidural analgesia in group 2. Perioperative IV PCA Fentanyl in groups 2,3. IM meperidine p.o. codeine/acetaminophen, IV acetaminophen and IV parecoxib in group 5 (control)
12019771|NCT00443391|Drug|ABT-089|Open label study, subjects will take up to 80mg daily for 24 months.
12019772|NCT00443378|Behavioral|CARE+|CARE+ is a .NET based application on tablet computers that comprises risk assessment, medication monitoring, tailored feedback, stage-based skills-building videos, motivational interviewing counseling, an integrated health promotion plan, and printout with referrals. Evidence-based approaches (pharmacist education, self-efficacy/importance scaling exercises, and consequence-framing) are incorporated.
12019773|NCT00443365|Procedure|Mitral valve repair|mitral valve annuloplasty
12019774|NCT00443352|Drug|duloxetine|Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
12019775|NCT00443339|Drug|Darbepoetin|
12019776|NCT00020475|Drug|gp100 antigen|
12019777|NCT00020475|Drug|interleukin-2|
12019778|NCT00020475|Drug|MART-1 antigen|
12019779|NCT00020475|Drug|Montanide ISA-51|
12019780|NCT00020371|Drug|BMS-247550|
12019781|NCT00020371|Drug|filgrastim|
12019782|NCT00020345|Drug|fluorouracil|
12019783|NCT00020345|Drug|gemcitabine|
12019784|NCT00020267|Drug|interleukin-2|
12019785|NCT00020267|Drug|MAGE-12 peptide vaccine|
12019786|NCT00020267|Drug|Montanide ISA-51|
12019787|NCT00443326|Drug|AMG 714|Dosing Regimen is 6 Doses over 3 Months
12019788|NCT00443287|Drug|ataciguat (HMR1766)|oral administration
12019789|NCT00443287|Drug|placebo|oral administration
12019790|NCT00443287|Drug|cilostazol|oral administration
12019791|NCT00443274|Other|NBIR Placeholder|
12019792|NCT00443274|Device|410 Arm|
12019793|NCT00443274|Device|BIFs|
12019794|NCT00443261|Drug|Azacitidine|SC azacitidine
12019795|NCT00443261|Drug|Cisplatin|cisplatin 75 mg/m^2 day 8 every 28 days
12019796|NCT00443248|Device|Vaginal Heat Wash-Out Device|No drug administered. Device tested twice with each subject.
12019797|NCT00443235|Drug|Melphalan/Prednisone/Velcade|"One cycle:
~Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)"
12019848|NCT00020046|Drug|docetaxel|
12019849|NCT00020046|Drug|thalidomide|
12019850|NCT00019968|Drug|melphalan|
12019798|NCT00443235|Drug|Thalidomide/Prednisone/Velcade|"One cycle:
~Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)
~Five cycles:
~Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)"
12019799|NCT00443222|Drug|Infliximab|
12019800|NCT00443209|Drug|Telcagepant 300 mg soft gel capsules|One capsule taken orally at onset of migraine
12019801|NCT00443209|Drug|Telcagepant 280 mg tablets|One tablet taken orally at onset of migraine
12019802|NCT00443209|Drug|Rizatriptan 10 mg tablets|One tablet taken orally at onset of migraine
12019803|NCT00443209|Drug|Placebo to telcagepant capsules|One capsule taken orally at onset of migraine
12019804|NCT00443209|Drug|Placebo to telcagepant tablets|One tablet taken orally at onset of migraine
12019805|NCT00443209|Drug|Placebo to rizatriptan tablets|One tablet taken orally at onset of migraine
12019806|NCT00443196|Procedure|MiCK Assay|Physician determined treatment
12019807|NCT00443183|Behavioral|Brief Negotiation Interview (BNI)|The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes.
12019808|NCT00443183|Behavioral|Discharge Instructions|Used as a placebo comparator, scripted discharge instructions are to be read by emergency practitioner and designed to be less than 1 minute in length.
12019809|NCT00443170|Drug|GSK626616, placebo, midazolam|
12019810|NCT00443170|Drug|omeprazole, caffeine, flurbiprofen, rosiglitazone|
12019811|NCT00443157|Biological|Meningococcal B Vaccine NZ|
12019812|NCT00443144|Drug|recombinant human growth hormone|
12019813|NCT00443131|Biological|GSK Malaria vaccine 257049|Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).
12019814|NCT00443118|Device|T-piece resuscitator Neopuff TM|Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
12019815|NCT00443118|Device|Self Inflating Bag with PEEP|Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
12019816|NCT00443118|Device|Self Inflating Bag without PEEP|Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
12019817|NCT00443105|Drug|Tacrolimus 0.03% ointment (Protopic)|
12019818|NCT00443092|Other|proprietary cherry juice blend (food)|2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
12019819|NCT00443092|Other|control juice (kool aid blend)|2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
12019820|NCT00443079|Drug|IdB 1016 (Siliphos)|1 pill 3 times daily x 3 months
12019821|NCT00443053|Drug|Fondaparinux 2.5mg or placebo|Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
12019822|NCT00443040|Drug|Asimadoline|Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.
12019823|NCT00443040|Drug|Placebo|Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.
12019824|NCT00443027|Device|Vaginal Heat Wash-Out Device|No drug administered. Device tested three times with each subject.
12019825|NCT00443014|Device|Cognitive, physical and social stimulation|Sessions of 30 minutes daily five days a week for one year
12019826|NCT00443001|Device|Non invasive blood pressure monitor|Updated device and software to improve performance in patients with dysrhythmia
12019827|NCT00442975|Biological|Fluarix|
12019828|NCT00442962|Drug|Efavirenz|600-mg tablet taken orally daily
12019829|NCT00442962|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily
12019830|NCT00442949|Procedure|Catheterization immediate PCI|Catheterization immediate PCI
12019831|NCT00442949|Procedure|delayed PCI|delayed PCI
12019832|NCT00442936|Drug|Telcagepant potassium 150 mg|Telcagepant 150 mg liquid-filled soft gel capsules
12019833|NCT00442936|Drug|Telcagepant potassium 300 mg|Telcagepant 300 mg liquid-filled soft gel capsules
12019834|NCT00442936|Drug|Zolmitriptan 5 mg|Zolmitriptan 5 mg tablets
12019835|NCT00442936|Drug|Placebo to telcagepant 150 mg|Placebo to match telcagepant 150 mg liquid-filled soft gel capsules
12019836|NCT00442936|Drug|Placebo to tecagepant 300 mg|Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
12019837|NCT00442936|Drug|Placebo to zolmitriptan 5 mg|Placebo to match zolmitriptan 5 mg tablets
12019838|NCT00442936|Drug|Rescue medication|If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.
12019839|NCT00442923|Drug|Coreg|
12019840|NCT00442910|Drug|3% SPL7013 Gel (VivaGel)|3% vaginal gel
12019841|NCT00442910|Drug|Placebo Gel|Placebo for SPL7013 gel
12019842|NCT00442910|Drug|HEC Placebo Gel|HEC Placebo gel intravaginally bd for 14 days
12019843|NCT00442897|Drug|simvastatin (+) ezetimibe|simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
12019844|NCT00442897|Drug|Comparator: atorvastatin|atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
12019845|NCT00442884|Behavioral|Trier Social Stress Test (TSST)|
12019846|NCT00442871|Drug|eltrombopag|eltrombopag 50 mg oral
12019859|NCT00019630|Drug|doxorubicin HCl liposome|
12019860|NCT00019448|Drug|gp100 antigen|
12019861|NCT00019448|Drug|interleukin-2|
12019862|NCT00019396|Drug|flt3 ligand|
12019863|NCT00019396|Drug|gp100 antigen|
12019864|NCT00019396|Drug|MART-1 antigen|
12019865|NCT00019396|Drug|Montanide ISA-51|
12019866|NCT00019396|Drug|tyrosinase peptide|
12019867|NCT00019188|Drug|interleukin-12|
12019868|NCT00019097|Drug|autologous tumor cell vaccine|
12019869|NCT00019097|Drug|keyhole limpet hemocyanin|
12019870|NCT00019097|Drug|melphalan|
12019871|NCT00019097|Drug|sargramostim|
12019872|NCT00003552|Drug|allogeneic lymphocytes|
12019873|NCT00003552|Drug|anti-thymocyte globulin|
12019874|NCT00003552|Drug|cyclophosphamide|
12019875|NCT00003552|Drug|fludarabine|
12019876|NCT00442845|Drug|Atorvastatin (Lipitor)|
12019877|NCT00442832|Drug|TD-1792|TD-1792 2 mg/kg/day IV
12019878|NCT00442832|Drug|Vancomycin|Vancomycin 1 Gm IV q 12 hrs
12019879|NCT00442819|Procedure|Hemodialysis with Polymethylmethacrylate Artificial Kidney|
12019880|NCT00442806|Drug|Injection of ADRC's|ADRC's are injected
12019881|NCT00442806|Other|Injection of Placebo|Placebo is injected
12019882|NCT00442793|Drug|Epoetin beta|As prescribed, 3 times weekly
12019883|NCT00442793|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|0.4 micrograms/kg iv every 2 weeks
12019884|NCT00442780|Drug|BIIB014|oral administration of BIIB014 per dose, schedule,and duration specified in protocol
12019885|NCT00442780|Drug|Placebo|Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
12019886|NCT00442767|Drug|Insulin|Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.
12019887|NCT00442767|Drug|Pramlintide + Insulin|30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
12019888|NCT00442754|Biological|Allogeneic Tumour Lysate (MelCancerVac)|subcutaneaus, /once weekly /4 wks then /4 weekly
12019889|NCT00442741|Drug|Patupilone|
12019890|NCT00442741|Drug|Patupilone + Omeprazole|
12019891|NCT00442728|Device|ELECTRICAL STIMULATION|
12019892|NCT00442715|Procedure|Exercise chalenge test|
12019893|NCT00442702|Drug|Mircera|Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.
12019894|NCT00442702|Drug|Darbepoetin alfa|As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
12019895|NCT00442689|Drug|flutamide|250 mg twice daily
12019896|NCT00442689|Drug|ethinyl estradiol 35 mcg and drospirenone 3 mg|one active pill per day for three weeks and then 1 sugar pill per day for one week
12019897|NCT00442689|Other|placebo|
12019898|NCT00442676|Drug|Celecoxib|Capsule, 200 mg/day until 32 weeks of gestation
12019899|NCT00442676|Drug|Placebo|Gelatin capsules of lactose
12019900|NCT00442663|Device|Transcervical Foley Catheter|
12019901|NCT00442663|Device|Transcervical Foley Catheter with an EASI|
12019902|NCT00442650|Drug|Efalizumab|
12019903|NCT00442637|Drug|capecitabine + bevacizumab|Ca 1250 mg/m2 daily orally continuously, B 7.5 mg/kg i.v. q 3 w
12019904|NCT00442637|Other|observation|observation after induction treatment
12019905|NCT00442611|Drug|Abatacept|
12019906|NCT00442611|Drug|Placebo|
12019907|NCT00442598|Drug|Glufosfamide|
12019908|NCT00442585|Drug|S(+)-ibuprofen|
12019909|NCT00442572|Drug|PEGASYS [peginterferon alfa-2a]|There were 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
12019910|NCT00442559|Drug|montelukast sodium|Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months
12019911|NCT00442559|Drug|inhaled corticosteroid|Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months
12019912|NCT00442546|Drug|pregabalin|150 milligram (mg)/ day (double blind)
12019913|NCT00442546|Drug|pregabalin|300 mg/day (double blind)
12019914|NCT00442546|Drug|Placebo|Placebo
12019915|NCT00442533|Drug|Indium-111 pentetreotide|4 cycles of 500 mCi treatments every 10-12 weeks
12019916|NCT00442507|Drug|Erlotinib|
12019917|NCT00442507|Drug|Avastin|
12019918|NCT00442494|Drug|intravenous hydrocortisone|
12019919|NCT00442481|Drug|Escitalopram|
12019920|NCT00442481|Procedure|A baseline overnight polysomnography (oPSG)|
12019921|NCT00442468|Other|Non-interventional study.|This is a non-interventional (no drug treatment administered), prevalence (observational) study.
12019922|NCT00442455|Drug|Erlotinib chlorhydrate|150 mg/day for 7 weeks
12019923|NCT00442455|Drug|Cisplatin|30 mg/m2 i.v. weekly for 7 weeks
12019924|NCT00442455|Procedure|Radiation therapy|63 Gy, five days a week, for 7 weeks
12019925|NCT00442442|Device|mosquito coils|mosquito coil / night mosquito coil & LLIN / night
12019926|NCT00442442|Device|LLIN|Sleep under LLIN every night
12019927|NCT00442416|Drug|Epoetin alfa|As prescribed, SC
12019928|NCT00442416|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120-360 micrograms SC monthly, starting dose
12019929|NCT00019578|Procedure|Sterotactic radiosurgery|
12019930|NCT00019006|Drug|Detox-B adjuvant|
12019931|NCT00019006|Drug|ras peptide cancer vaccine|
12019932|NCT00442403|Drug|chloroquine|
12019933|NCT00442403|Drug|dehydroepiandrosterone sulphate|
12019934|NCT00442390|Drug|hydrocortisone substitution therapy versus withdrawal|
12019935|NCT00442377|Procedure|exposure to malaria sporozoites|
12019936|NCT00442364|Drug|Polidocanol (1%) Microfoam (Varisolve)|Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.
12019937|NCT00442364|Procedure|Endovenous Microfoam Occlusion|Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.
12019938|NCT00442351|Drug|Asmanex twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
12019939|NCT00442351|Other|Placebo for Asmanex twisthaler|Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
12019940|NCT00442338|Drug|montelukast sodium|Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
12019941|NCT00442338|Drug|montelukast sodium|Montelukast 14 mg single injection (IV bolus administration) over 5 minutes
12019942|NCT00442338|Drug|aminophylline hydrate|Aminophylline 250 mg IV drip infusion over 60 minutes
12019943|NCT00442325|Drug|Atorvastatin (Lipitor)|
12019944|NCT00442312|Drug|Combigan Ophthalmic Solutiom|
12019945|NCT00442299|Device|Fractionated Plasma Separation and Adsorption (FPSA)|
12019946|NCT00442286|Device|Rheos® Baroreflex Hypertension System|Electrical activation of the Carotid Baroreflex
12019947|NCT00442273|Drug|Umbilical cord serum eyedrops|
12019948|NCT00442273|Drug|Autologous serum eyedrops|
12019949|NCT00442260|Drug|DOXIL|
12019950|NCT00442260|Drug|Abraxane|
12019951|NCT00442247|Device|Pelvicol|
12019952|NCT00442234|Drug|Monteplase|
12019953|NCT00442221|Drug|Sumatriptan and Naproxen sodium|
12019954|NCT00442208|Drug|PN 200|
12019955|NCT00442182|Drug|ITF2357|
12019956|NCT00442169|Biological|ChimeriVax-WN02 Low Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region.
12019957|NCT00442169|Biological|ChimeriVax-WN02 Medium Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
12019958|NCT00442169|Biological|ChimeriVax-WN02 High Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
12019959|NCT00442169|Biological|0.9% Saline solution|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
12019960|NCT00442169|Biological|ChimeriVax-WN02 High Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
12019961|NCT00442169|Biological|0.9 % NaCl solution|Single dose given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
12019962|NCT00442156|Procedure|Laser photocoagulation|modified ETDRS focal photocoagulation generally completed in a single sitting on the day of enrollment, but if little or no improvement, may be repeated at 16 weeks
12019963|NCT00442143|Procedure|Stem cell implantation|
12019964|NCT00442130|Biological|GM-K562 vaccine|The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines.
12019965|NCT00442130|Procedure|stem cell transplantation|Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation
12019966|NCT00442117|Drug|mometasone furoate dry powder inhaler|MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.
12019967|NCT00442117|Drug|Budesonide DPI|Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.
12019968|NCT00442104|Drug|Ganaxolone|
12019969|NCT00442091|Drug|dandelion juice|10 ml bid for 20-30 days
12019970|NCT00442078|Device|I-STOP TOMS male sling|Bulbus urethral compression with polypropylene mesh
12019971|NCT00442065|Device|Aorfix™ Stent Grafts (AAA endovascular procedure)|Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System
12019972|NCT00442052|Drug|aspirin|
12019973|NCT00442052|Drug|omeprazole|
12019974|NCT00442039|Drug|Lithium Carbonate|The starting dose of lithium was 300 mg for patients weighing < 20 kg
12019975|NCT00442039|Drug|Lithium Carbonate|"The dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patients response and tolerability. The starting dose of lithium was 900 mg and the dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patients response and tolerability"
12019976|NCT00442039|Drug|Lithium Carbonate|"The starting dose of lithium was 900 mg and the lithium dose was increased by 300 mg every 3 days, (no more than twice weekly) to maximum tolerated dose based upon the patients response and tolerability."
12019977|NCT00442039|Drug|Placebo|During the third phase, which is the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks.
12019978|NCT00442026|Drug|Docetaxel|Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
12019979|NCT00442026|Drug|Gemcitabine|Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
12019980|NCT00442026|Drug|Gemcitabine|Gemcitabine at the dose of 1200mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
12019981|NCT00442013|Drug|Lansoprazole|Participants less than 30 kg will receive 15 mg a day, by mouth; participants greater than or equal to 30 kg will receive 30 mg a day, by mouth.
12019982|NCT00442013|Drug|Matching placebo|Participants will receive a placebo pill on a daily basis. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.
12019983|NCT00442000|Procedure|Prostatectomy|Patients undergoing prostatectomy.
12019984|NCT00441987|Drug|GSI-953|
12019985|NCT00441974|Drug|adefovir dipivoxil|adefovir dipivoxil once daily one tablet 10mg orally
12019986|NCT00441961|Drug|methotrexate|methotrexate
12019987|NCT00441948|Device|Peterio|
12019988|NCT00441935|Device|Interstim Neuromodulation|Two stage procedure to implant an interstim device for neuromodulation.
12019989|NCT00441922|Drug|Docetaxel|Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
12019990|NCT00441922|Drug|Vinorelbine|Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
12019991|NCT00441909|Drug|UC-781|0.1% UC-781 Vaginal Gel
12019992|NCT00441909|Drug|UC-781 placebo|Vaginal Gel Placebo
12019993|NCT00441896|Drug|Ganaxolone|
12019994|NCT00441896|Other|Placebo|
12019995|NCT00441883|Drug|PF-03187207 and Latanoprost Vehicle|
12019996|NCT00441883|Drug|Latanoprost 0.005% and PF-03187207 Vehicle|
12019997|NCT00441870|Drug|EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)|Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)
12019998|NCT00441870|Drug|99mTC-EC20 (Folic acid-technetium 99m conjugate)|20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging
12019999|NCT00441857|Behavioral|plant stanol consumption|
12020000|NCT00441844|Drug|Simvastatin|
12020001|NCT00441818|Drug|TNX-650|
12020002|NCT00441805|Device|Radio Frequency|
12020003|NCT00441792|Drug|Etomidate|Etomidate at induction dose based on weight
12020004|NCT00441792|Drug|midazolam|Midazolam at induction dose based on weight
12020005|NCT00441766|Drug|AGN 203818|Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks
12020006|NCT00441766|Drug|AGN 203818|Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks
12020007|NCT00441766|Drug|AGN 203818|Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks
12020008|NCT00441766|Drug|placebo|Part A: placebo capsule every 12 hours for 4 weeks
12020009|NCT00441740|Drug|Vinorelbine|Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
12020010|NCT00441740|Drug|Gemcitabine|Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
12020011|NCT00441740|Drug|Docetaxel|Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
12020012|NCT00441740|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
12020013|NCT00441727|Drug|Esomeprazole 40 mg|Esomeprazole 40 mg once daily
12020014|NCT00441727|Drug|Esomeprazole 20 mg|Esomeprazole 20 mg once daily
12020015|NCT00441727|Drug|Placebo|Placebo once daily
12020016|NCT00441714|Procedure|repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise|
12020017|NCT00441701|Drug|Navarixin 1 mg|Navarixin 1 mg capsules
12020018|NCT00441701|Drug|Navarixin 10 mg|Navarixin 10 mg capsules
12020019|NCT00441701|Drug|Placebo to match navarixin|Placebo to navarixin capsules
12020020|NCT00441701|Drug|Rescue medication|Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief
12020021|NCT00441688|Drug|GI265235|
12020022|NCT00441675|Procedure|Symptom Score|Symptom Score
12020023|NCT00441675|Procedure|Symptom Score and PD20|Symptom Score and PD20
12020024|NCT00441662|Drug|Sub-Tenon triamcinolone 40mg|
12020025|NCT00441649|Drug|Methylphenidate|
12020026|NCT00441636|Device|continuous positive airway pressure (CPAP)|CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist
12020027|NCT00441623|Behavioral|observational|effect of protein-bound uremic retention solutes
12020028|NCT00441610|Drug|Gimatecan|
12020029|NCT00441597|Drug|atorvastatin|atorvastatine 80mg, during 3 days
12020030|NCT00441584|Biological|PegIntron (peginterferon alfa-2b)|Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
12020031|NCT00441584|Drug|Rebetol (ribavirin)|200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks
12020032|NCT00441571|Drug|177Lu-CYT-500|
12020033|NCT00441558|Drug|Flibanserin|flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
12020034|NCT00441545|Drug|Fosrenol (Lanthanum Carbonate)|The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
12020035|NCT00441545|Drug|Sevelamer hydrochloride|The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
12020036|NCT00441532|Drug|Lidocaine|
12020037|NCT00441519|Drug|aspirin|
12020038|NCT00441519|Drug|omeprazole|
12020039|NCT00441506|Drug|daily interruption of sedatives|
12020040|NCT00441493|Drug|fluvastatin|
12020041|NCT00441480|Dietary Supplement|Plant sterols esters|1.6g phytosterols and 1.3g omega-3 fatty acids per day
12020042|NCT00441480|Dietary Supplement|placebo|4 gr of corn oil
12020043|NCT00441467|Drug|Glufosfamide|5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
12020044|NCT00441454|Device|Transobturator Tension-free vaginal tape (TVT-O)|tension-free vaginal tape (TVT)
12020045|NCT00441454|Device|Retropubic Tension-free vaginal tape (TVT)|Retropubic Tension-free vaginal tape (TVT)
12020046|NCT00441441|Drug|fluticasone propionate|fluticasone propionate 100mcg HFA
12020047|NCT00441441|Drug|fluticasone propionate/salmeterol|fluticasone propionate/salmeterol 100/50mcg HFA
12020048|NCT00441428|Drug|solifenacin|
12020049|NCT00441415|Drug|Adapalene BPO|
12020050|NCT00441376|Drug|ThermoDox|15 ml vial containing 2mg/ml Doxorubicin HCl, DPPC, MSPC, DSPE-MPEG 2000. Administered as single dose intravenously over 30 minutes. Dose is determined by dose cohort patient enters study.
12020051|NCT00441363|Drug|Bromocriptine Mesylate|0.8 mg tablet
12020052|NCT00441350|Drug|OM 40|Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.
12020053|NCT00441350|Drug|OM/HCTZ 40/12.5|Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.
12020054|NCT00441337|Biological|MDX-1106|patients will receive a single dose of MDX-1106 as a 60 minute infusion.
12020055|NCT00441324|Procedure|recombinant human LH|
12020105|NCT00440947|Drug|Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)|Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV)+ ritoanvir (/r) for 36weeks followed by ABC/3TC + ATV + /r for 48wks followed by optional treatment extension for 60 weeks on the same regimen
12020056|NCT00441311|Behavioral|Academic Detailing|The academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also be customized to each physician, although the frequency of the detailing visits will be routinized across all participants to reduce cost and to maximize its potential for dissemination.
12020057|NCT00441298|Drug|Tenofovir gel|Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
12020058|NCT00441298|Drug|Placebo (Universal HEC placebo)|Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
12020059|NCT00441285|Drug|Praziquantel|- Praziquantel 50 mg / kg / d (up to 3600 mg / d ) for 10 days.
12020060|NCT00441285|Drug|Albendazole|"Albendazole 15 mg / kg / d ( up to 800 mg /d ) in Arm I for 10 days.
~Albendazole at an increased dose, 22.5 mg / kg / d (up to 1200 mg / d ), in Arm II for 10 days."
12020061|NCT00441285|Drug|ABZ Placebo|- Placebo (of Albendazole ) 7.5 mg / kg / d in Arm I and II for 10 days.
12020062|NCT00441285|Drug|PZQ Placebo|- Placebo (of Praziquantel) 50 mg / kg / d in Arm II and III for 10 days.
12020063|NCT00441272|Drug|Pioglitazone|
12020064|NCT00441259|Biological|ChimeriVax™-JE|One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously
12020065|NCT00441259|Biological|Japanese Encephalitis Inactivated Mouse Brain Vaccine|Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously
12020066|NCT00441246|Drug|Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)|
12020067|NCT00441233|Device|Silicone hydrogel contact lens|
12020068|NCT00441207|Drug|Ascorbic Acid|Delivered via IV Infusion.
12020069|NCT00441194|Device|Visual Field (Octopus 311 and the HFA 700 series)|
12020070|NCT00441181|Drug|Travoprost|
12020071|NCT00441168|Drug|adriamycin|adriamycin: 9mg/m² intravenous (IV) push on days 1 to 4
12020072|NCT00441168|Drug|bortezomib|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11
12020073|NCT00441168|Drug|dexamethasone|dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
12020074|NCT00441168|Drug|vincristine|vincristine: 0.4mg IV push on days 1 to 4
12020075|NCT00441155|Drug|Nilotinib, Imatinib|Nilotinib 50 mg and 200 mg gelatin capsules and Imatinib 100 mg and 400 mg film-coated tablets in bottles.. Medication labels for each study drug complied with the legal requirements of each country, were printed in the local language.
12020076|NCT00441142|Drug|ZD6474|Taken orally once a day (at 100 mg/day is the phase II dose; the MTD determined by the phase I portion of the trial) until disease gets worse or participants experience unacceptable side effects
12020077|NCT00441142|Drug|temozolomide|"During the 'Induction' phase: 75/mg/m2/day temozolomide will be given orally daily for 6 weeks (42 days) during radiation therapy, beginning either the night before or on the first day of the first fraction of radiation, including weekends and holidays. This is followed by a 4-6 week break.
~During the 'Maintenance' phase: The first post-radiation temozolomide cycle will be administered at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle. If 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given. This is given for 12 cycles."
12020078|NCT00441142|Radiation|Radiation Therapy|Radiotherapy must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy.
12020079|NCT00441129|Device|Minimed paradigm Real Time Sytem|Minimed paradigm Real Time Sytem
12020080|NCT00441129|Device|Minimed Paradigm 512/712 Insulin pump|Minimed Paradigm 512/712 Insulin pump
12020081|NCT00441116|Drug|Dutasteride 0.5mg oral tablets|Dutasteride
12020082|NCT00441103|Drug|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.
12020083|NCT00441103|Drug|Placebo|Matching placebo will be administered subcutaneously three times a week for 16 weeks.
12020084|NCT00441103|Drug|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.
12020085|NCT00441090|Drug|Placebo|Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
12020086|NCT00441090|Drug|Avatrombopag tablets|Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
12020087|NCT00441077|Behavioral|Education|
12020088|NCT00441064|Drug|Aliskiren|
12020089|NCT00441051|Drug|Diclofenac sodium 1mg/g|
12020090|NCT00441038|Behavioral|The Back Guide|Education on postural hygiene and handout of The Back Guide
12020091|NCT00441038|Behavioral|The Back Book|Education on active management and Handout of The Back Book
12020092|NCT00441038|Behavioral|Cardiovascular and general health|Education on cardiovascular and general health
12020093|NCT00441025|Drug|Alemtuzumab|
12020094|NCT00441012|Biological|Comparator: Modified Process Vaccine|Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.
12020095|NCT00441012|Biological|Comparator: COMVAX™|COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.
12020096|NCT00440999|Drug|Pyronaridine artesunate|
12020097|NCT00440999|Drug|Chloroquine|
12020098|NCT00440986|Procedure|Eritrocytoapheresis|
12020099|NCT00440973|Drug|Bevacizumab|monoclonal antibody with anti-angiogenesis properties used as chemotherapy
12020100|NCT00440973|Drug|Interleukin-2|immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T & B lymphocyte proliferation
12020106|NCT00440947|Drug|Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)|Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV) + ritonavir (/r) for 36 weeks followed by ABC/3TC + ATV for 48wks followed by optional treatment extension for 60 weeks on the same regimen
12020107|NCT00440934|Device|Amplitude-modulated electromagnetic fields|
12020108|NCT00440921|Drug|Single donor Allogenous Fibrin Sealant|
12020109|NCT00440895|Drug|Abciximab|Abciximab (bolus) i.c. or i.v. or placebo, bolus dose is calculated according to current dosage (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
12020110|NCT00440869|Dietary Supplement|N-acetylcysteine|600 mg po bid
12020111|NCT00440869|Dietary Supplement|placebo|bid oral dosing
12020112|NCT00440856|Behavioral|Presentation of excised intervertebral disc fragments|
12020113|NCT00440843|Drug|Olanzapine (Zyprexa)|OLZ
12020114|NCT00440843|Drug|Typicals|Stay on typicals regimen
12020115|NCT00440830|Drug|nicotine patch|nicotine patch (0,5,10 or 15mg/day) applied to smokers
12020116|NCT00440830|Drug|nicotine patch|nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers
12020117|NCT00440830|Drug|placebo|placebo patch applied to smokers
12020118|NCT00440830|Drug|placebo|placebo patch applied to nonsmokers
12020119|NCT00440817|Other|No intervention|All treatments are prescribed by a physician on the basis of usual clinical practice.
12020120|NCT00440804|Drug|ibuprofen l-lysine iv solution (NeoProfen (R) )|
12020121|NCT00440791|Device|PillCam Colon capsule endoscopy|
12020122|NCT00440778|Drug|Abciximab|100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion
12020123|NCT00440765|Drug|bortezomib|dose as determined (observational study) by treating physician
12020124|NCT00440739|Drug|etoricoxib|etoricoxib 120 mg
12020125|NCT00440739|Drug|flavoxate|flavoxate 200 mg 3 times
12020126|NCT00440739|Drug|etoricoxib, flavoxate|etoricoxib 120 mg once and flavoxate 200 mg 3 times
12020127|NCT00440739|Drug|placebo|placebo once and placebo 3 times
12020128|NCT00440726|Drug|Bortezomib|Intravenous on days 1, 4, 8 and 11. Dose assigned at study entry.
12020129|NCT00440726|Drug|Dexamethasone|10 mg/m2/day divided BID, oral administration for 14 days.
12020130|NCT00440726|Drug|PEG-asparaginase|2500 IU/m2/day, intramuscular injection on Days 2, 8, 15 and 22
12020131|NCT00440726|Drug|Doxorubicin|60 mg/m2/day IV over 15 minutes on Day 1
12020132|NCT00440726|Drug|Cytarabine|"Given intrathecally on Day 1 of course 1 at the dose defined by age below.
~30 mg for patients age 1-1.99
~50 mg for patients age 2-2.99
~70 mg for patients >3 years of age"
12020133|NCT00440726|Drug|Methotrexate|"Given intrathecally to all patients who are CNS 1 at study entry on Day 15 at the dose defined by age below.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age"
12020134|NCT00440726|Drug|Vincristine|1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22.
12020135|NCT00440726|Drug|Triple IT Therapy|"Triple IT therapy will be given intrathecally on Day 8, 15, and 22 for patients who are CNS 2 and CNS 3 at study entry. Regimen/dosing as follows:
~Methotrexate-
~<2 years: 8 mg
~2 - <3 y: 10 mg
~3 - <9 y: 12 mg
~>=9 y: 15 mg
~Cytarabine:
~<2 years: 16 mg
~2 - <3 y: 20 mg
~3 - <9 y: 24 mg
~>=9 y: 30 mg
~Hydrocortisone:
~<2 years: 8 mg
~2 - <3 y: 10 mg
~3 - <9 y: 12 mg
~>=9 y: 15 mg"
12020136|NCT00440713|Drug|Aripiprazole|
12020137|NCT00440713|Behavioral|Interpersonal Therapy|
12020138|NCT00440700|Behavioral|Anxiety Self-Management, Patient preferred relaxing music|Experimental group randomized to patient-directed music intervention where subjects listened to tailored, self-selected music as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.
12020139|NCT00440700|Behavioral|Control 1: Noise-cancelling headphones|Control group: noise-canceling headphones only where subjects wear headphones as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.
12020140|NCT00440700|Behavioral|Control 2: Standard of Care|Usual ICU nursing care.
12020141|NCT00440687|Drug|Fluticasone 500mcg BD via accuhaler or identical placebo|
12020142|NCT00440674|Device|CoStar Paclitaxel-eluting coronary stent system|
12020143|NCT00440661|Drug|Diacerhein|
12020144|NCT00440648|Drug|sevelamer carbonate, sevelamer hydrochloride|Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
12020145|NCT00440648|Drug|sevelamer hydrochloride, sevelamer carbonate|Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
12020146|NCT00440635|Drug|Bortezomib, tradename Velcade|
12020147|NCT00440622|Drug|Gemcitabine|Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
12020148|NCT00440622|Drug|Herceptin|Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV
12020149|NCT00440622|Drug|Capecitabine (Xeloda)|Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles
12020150|NCT00440609|Drug|ranibizumab|0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose.
12020151|NCT00440596|Behavioral|Mindfulness based stress reduction|8 weeks group MBSR
12020152|NCT00440596|Behavioral|Progressive Muscle Relaxation|8 weeks PMR in group format
12020153|NCT00440583|Drug|chemotherapy followed by Zevalin|6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin
12020154|NCT00440570|Device|Low levels of amplitude-modulated electromagnetic fields|
12020155|NCT00440570|Device|Emitter of low levels of amplitude-modulated electromagnetic fields|
12020156|NCT00440557|Drug|Epoetin alfa 3 times weekly /once weekly|Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks)
12020157|NCT00440557|Drug|Epoetin alfa once weekly|Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).
12020158|NCT00440557|Drug|Epoetin alfa once every two weeks|Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).
12020159|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen in BCG naive subjects
12020160|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
12020161|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|50 ug H1 antigen in BCG immunized subjects
12020162|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
12020163|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen in BCG immunized subjects
12020164|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
12020165|NCT00440531|Biological|Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)|RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
12020166|NCT00440531|Biological|Comparator: Modified Process Hepatitis B Vaccine (Experimental)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
12020167|NCT00440531|Biological|Comparator: ENGERIX-B™ (currently licensed product)|ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.
12020168|NCT00440518|Drug|Lacosamide|Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
12020169|NCT00440518|Other|Placebo|Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart
12020170|NCT00440518|Drug|Lacosamide|Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
12020171|NCT00440505|Drug|Placebo|Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
12020172|NCT00440505|Drug|Nicotine (5 mg)|Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
12020173|NCT00440505|Drug|Nicotine (10 mg)|Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
12020174|NCT00440492|Drug|PLA-695|
12020175|NCT00440479|Drug|Bortezomib|dose as determined (observational study) by treating physician
12020176|NCT00440466|Drug|epoetin alfa|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
12020177|NCT00440466|Drug|epoetin alfa|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
12020178|NCT00440466|Drug|epoetin alfa|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
12020179|NCT00440453|Other|Nutritional therapy|Nutritional therapy by dietician
12020180|NCT00440440|Drug|Testosterone gel|Testosterone gel to be applied daily, starting does 5g.
12020181|NCT00440440|Drug|placebo|placebo gel apply daily
12020182|NCT00440427|Drug|Desvenlafaxine Sustained Release (DVS SR)|
12020183|NCT00440414|Drug|Erlotinib (Tarceva)|Erlotinib at the dose of 150 mg orally once a day continually until progression
12020184|NCT00440414|Drug|Pemetrexed (Alimta)|Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
12020185|NCT00440401|Drug|fibrinogen (human) + thrombin (human)|
12020186|NCT00440401|Drug|Standard haemostatic treatment in cardiovascular surgery|Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)
12020187|NCT00440388|Drug|AT-101|AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles.
12020188|NCT00440388|Drug|Rituximab|Rituximab 375mg/m2 IV once per week for four weeks during 1st cycle, 375mg/m2 IV once per cycle for cycles 2-5. Cycle = 56 days; Max of 5 cycles.
12020189|NCT00440375|Drug|Rosiglitazone|
12020190|NCT00440362|Biological|AVX502|1 dose at 2e8 IU given at t=0 via IM route
12020191|NCT00440362|Biological|AVX502|1 dose at 2e7 IU given at T=0 via the IM route
12020192|NCT00440362|Biological|AVX502|1 dose at 2e7 IU given at t=0 via the SC route
12020193|NCT00440362|Biological|AVX502|1 dose at 2e8 IU given at T=0 via the SC route
12020194|NCT00440362|Biological|AVX502|2 doses at 2e7 IU given at T=0 and 8 weeks via the IM route
12020195|NCT00440362|Biological|AVX502|2 doses at 2e8 IU given at T=0 and 8 weeks via the IM route
12020196|NCT00440362|Biological|AVX502|2 doses of 2e7 IU given at t=0 and 8 weeks via the SC route
12020197|NCT00440362|Biological|AVX502|2 doses at 2e8 IU given at T=0 and 8 weeks via the SC route
12020198|NCT00440362|Biological|Placebo|1 dose of placebo given at T=0 via the IM route
12020199|NCT00440362|Biological|Placebo|1 dose of placebo given at T=0 via the SC route
12020200|NCT00440362|Biological|Placebo|2 doses of placebo given at T=0 and 8 weeks via the IM route
12020201|NCT00440362|Biological|Placebo|2 doses of placebo given at T=0 and 8 weeks via the SC route
12020202|NCT00440349|Drug|Tamoxifen|
12020203|NCT00440349|Drug|Prednisone|
12020204|NCT00440336|Drug|Cosopt|
12020205|NCT00440336|Drug|Xalatan|
12020206|NCT00440323|Drug|SB-649868|SB-649868 tablets will be available with dose strength of 5 and 25 mg.
12020207|NCT00440323|Drug|Zolpidem|Zolpidem capsules will be available with dose strength of 10 mg.
12020208|NCT00440323|Drug|Placebo|Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
12020209|NCT00440310|Drug|Talaporfin sodium|LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
12020210|NCT00440310|Procedure|Percutaneous placement of device in liver metastases|Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
12020211|NCT00440310|Device|Interstitial light emitting diodes|200 J/cm per Light Source at 20 mW/cm light energy
12020212|NCT00440310|Drug|FOLFOX4 regimen|Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
12020213|NCT00440310|Drug|FOLFIRI regimen|Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
12020214|NCT00440297|Biological|Comparator: modified process hepatitis B vaccine|Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
12020215|NCT00440297|Biological|Comparator: ENGERIX-B™|ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
12020216|NCT00440284|Drug|conventional vs. flexible, intensive insulin therapy|
12020217|NCT00440271|Drug|tipranavir|
12020218|NCT00440271|Drug|ritonavir|
12020219|NCT00440271|Drug|Optimized Background Regimen (OBR)|Patients received between two and four active anti-retroviral medications based on resistance testing results, as background treatment, and remained on these for the duration of the trial.
12020220|NCT00440258|Drug|Cabergoline|
12020221|NCT00440258|Procedure|MR|
12020222|NCT00440258|Procedure|Ultrasound|
12020223|NCT00440258|Procedure|Blood Analysis|
12020224|NCT00440245|Drug|salbutamol|200 micrograms salbutamol from MDI
12020225|NCT00440232|Drug|Frovatriptan|Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast
12020226|NCT00440232|Drug|Placebo|Inert tab identical in appearance to Frovatriptan
12020227|NCT00440219|Drug|Oral Prednisone|Prednisone 50 mg once daily for 10 days pre-op
12020228|NCT00440219|Drug|Placebo comparator|Placebo pill identical to Prednisone 10 days once daily pre-op
12020229|NCT00440193|Drug|Rivaroxaban (Xarelto, BAY59-7939)|During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
12020230|NCT00440193|Drug|Enoxaparin followed by VKA|Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
12020231|NCT00440180|Drug|Anastrozole|1 mg qd for 4 months
12020232|NCT00440180|Drug|Placebo|Placebo Comparator
12020233|NCT00440167|Drug|Gemcitabine|Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
12020234|NCT00440167|Drug|Capecitabine|"Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause (Flat Dosing)"
12020235|NCT00440167|Drug|Erlotinib|Erlotinib 150 mg/d oral, daily without break
12020236|NCT00440154|Drug|AVE5530|
12020237|NCT00440154|Drug|placebo|
12020238|NCT00440154|Drug|ezetimibe|
12020239|NCT00440141|Drug|latanoprost 0.005% eye drops and brimonidine 0.1% eye drops|latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
12020240|NCT00440141|Drug|latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops|latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months
12020241|NCT00440128|Drug|Docetaxel|Docetaxel
12020242|NCT00440128|Drug|Casopitant/Docetaxel|Casopitant/Docetaxel
12020243|NCT00440115|Behavioral|High intensity disease management|Health education mailings, 6 motivation interviews/counseling
12020244|NCT00440115|Behavioral|Low intensity disease management|Health education mailings, one motivation interview/counseling
12020245|NCT00440115|Behavioral|Comparison group|Health education mailings
12020246|NCT00440115|Drug|Bupropion|Buproprion or Nicotine Replacement Therapy
12020247|NCT00440102|Drug|Ketamine|Ketamine
12020248|NCT00440102|Drug|Etomidate|Etomidate
12020249|NCT00440089|Behavioral|Hands-on-Healing|
12020250|NCT00440076|Drug|Velcade|
12020251|NCT00440063|Drug|epoetin beta [NeoRecormon]|
12020252|NCT00440050|Drug|DHA (Docosahexaenoic Acid)|950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months
12020253|NCT00440050|Drug|Placebo|2 placebo capsules twice a day for 18 months
12020254|NCT00440037|Biological|AMG 531|AMG 531 will be administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG 531 is 10 μg/kg. AMG 531 will be supplied as a sterile, white, preservative-free, lyophilized powder in 5 mL glass vials containing 0.6 mg of protein per vial, and a protein concentration of 0.5 mg/mL when reconstituted with 1.2 mL of sterile water for injection.
12020255|NCT00440024|Drug|Tazorac|Tazarotene 0.1% cream applied to the face once daily before bed
12020256|NCT00440024|Drug|Dove Mild Cleanser|Ultra mild cleanser: Dove Non-foaming cleansing lotion
12020257|NCT00440024|Drug|Dove Facial Moisturizer|Moisturizing cream - Dove facial moisturizer with SPF 15
12020258|NCT00440011|Drug|bimatoprost 0.03% eye drops|bimatoprost 0.03% 1 drop nightly for 3 months
12020259|NCT00440011|Drug|travoprost 0.004% eye drops|travoprost 0.004% 1 drop nightly for 3 months
12020260|NCT00439998|Procedure|Ultrasound|ultrasound scan of the lumbar spine with 2-5 MHz curved array probe
12020261|NCT00439985|Behavioral|Cognitive Behavioral Therapy|The treatment which incorporates cognitive restructuring and skill training, was designed to help children with diabetes and their families develop particular skills and optimistic/positive thinking style in order to facilitate better coping with the enduring demands and stress of diabetes management. The goal of the intervention was to improve the child's diabetes management both medically and psychologically by promoting optimism (positive outlook), mastery (problem-solving) and child-parent collaboration (team-work).
12020262|NCT00439972|Drug|Ortho-Cyclen (R)|The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study.
12020263|NCT00439972|Drug|Ortho Evra (R)|Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
12020318|NCT00439595|Device|Hemocue 210 meter|Diagnostic device
12020319|NCT00439595|Device|Copack HBCS|
12020264|NCT00439972|Drug|extended use of Ortho Evra (R)|The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
12020265|NCT00439959|Drug|GSK625433/placebo|
12020266|NCT00439946|Drug|treprostinil|rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
12020267|NCT00439946|Device|Crono Five ambulatory pump|Used for administration of IV Remodulin (treprostinil)
12020268|NCT00439933|Behavioral|low fat and polysaccharide rich diet|
12020269|NCT00439933|Behavioral|specific physical training program for obese children|
12020270|NCT00439920|Drug|High-dose anthracycline|
12020271|NCT00439907|Procedure|End-to-end repair of the external anal sphincter muscle|Surgical procedure: End-to-end repair of the external anal sphincter muscle
12020272|NCT00439907|Procedure|Overlap repair of the external anal sphincter muscle|Surgical procedure: Overlap repair of the external anal sphincter muscle
12020273|NCT00439894|Procedure|Blood draw|blood draw at baseline, week 12 and week 24
12020274|NCT00439881|Drug|SB-681323|
12020275|NCT00439868|Drug|WellbutrinXL|WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
12020276|NCT00439868|Drug|placebo|Matching placebo tablets to WELLBUTRIN XL.
12020277|NCT00439855|Drug|Enoxaparin i.v.|
12020278|NCT00439855|Drug|unfractionated heparin|
12020279|NCT00439842|Behavioral|Heart Failure Group Clinic Appointments|Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
12020280|NCT00439829|Drug|Gonal F|"450 IU Gonal-f (Serono Canada) subcutaneously daily (225 IU BID; injections to be given after bloodwork).
~Dosing to begin on day 1 or day 4 (day 1=first day of menses), continuing until administration of human Chorionic Gonadotropin (hCG; see below).
~Gonal-f dose may be further reduced, at the discretion of the study physician, to minimize the risk of OHSS."
12020281|NCT00439829|Drug|Luveris|"0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:
~leading follicle is > 13 mm in diameter
~if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
~Dosing to continue until administration of hCG (see below)."
12020282|NCT00439829|Drug|Cetrotide|"0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:
~leading follicle is > 13 mm in diameter
~if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
~Dosing to continue until administration of hCG (see below)."
12020283|NCT00439829|Drug|hCG|"- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when:
~o > 3 follicles are > 17 mm in diameter"
12020284|NCT00439816|Behavioral|Group Visits|
12020285|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
12020286|NCT00439803|Biological|Placebo|3 doses of placebo given at T=0, 8, 24 weeks via the IM route
12020287|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
12020288|NCT00439803|Biological|Placebo|3 doses of placebo given at T=0, 8, 24 weeks via the SC route
12020289|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
12020290|NCT00439803|Biological|AVX601|3 doses of placebo given at T=0, 8, 24 weeks via the IM route
12020291|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
12020292|NCT00439803|Biological|Placebo|3 doses of placebo given at T=0, 8, 24 weeks via the SC route
12020293|NCT00439790|Procedure|Microneurography|Microneurography
12020294|NCT00439777|Drug|Rivaroxaban (Xarelto, BAY59-7939)|During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
12020295|NCT00439777|Drug|Enoxaparin overlapping with and followed by VKA|Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
12020296|NCT00439764|Behavioral|General health talk|Routine clinical practice and talk on general health
12020297|NCT00439764|Behavioral|Handout of The Back Book|Talk on health of the back and handout of The Back Book
12020298|NCT00439764|Behavioral|Back exercise|Routine clinical practice, talk on back health, handout of The Back Book and back exercise
12020299|NCT00439751|Drug|Goserelin Acetate|Continuous goserelin, 12 week (10.8 mg) depot, will be used as ADT for both study arms. It is supplied as a sterile syringe for subcutaneous use.
12020300|NCT00439738|Drug|HCTZ + Amlodipine|"12.5 mg HCTZ capsules
~25 mg HCTZ capsules
~5 mg amlodipine capsules
~10 mg amlodipine capsules"
12020301|NCT00439738|Drug|Valsartan/HCTZ|"160 mg film-coated valsartan tablets
~320 mg film-coated valsartan tablets
~12.5 mg HCTZ capsules
~25 mg HCTZ capsules"
12020302|NCT00439725|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
12020303|NCT00439725|Drug|Placebo|Patients allocated to placebo will receive a matching placebo tablet once daily.
12020304|NCT00439712|Drug|Levocetirizine|1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days
12020305|NCT00439712|Drug|Placebo|1 placebo tablet OD in the morning for 29+/-4 days
12020306|NCT00439699|Drug|Memantine|Mematine administration
12020307|NCT00439686|Drug|ZIO-201|ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months
12020308|NCT00439673|Drug|5-Azacytidine|
12020309|NCT00439673|Drug|Valproic Acid|
12020310|NCT00439673|Drug|ATRA|
12020311|NCT00439660|Biological|Oral Rotavirus Vaccine 116E Live Attenuated|
12020312|NCT00439647|Drug|Zoledronic acid 5 mg iv|Zoledronic acid 5 mg iv given once a year.
12020313|NCT00439647|Drug|Placebo|Placebo intravenous (i.v.) once a year
12020314|NCT00439634|Drug|AVE1625|oral administration
12020315|NCT00439634|Drug|placebo|oral administration
12020316|NCT00439621|Biological|RP 01|Active immunotherapy
12020317|NCT00439608|Drug|Cetuximab,Paclitaxel, Carboplatin|IV treatment for 6 weeks
12020320|NCT00439582|Dietary Supplement|vaccenic acid enriched milk fat (VAMF) [Transfact1]|
12020321|NCT00439582|Dietary Supplement|hydrogenated oil|Partially hydrogenated vegetable oils (PHVO) and vegetable oils and fats
12020322|NCT00439569|Drug|sodium phenylbutyrate|500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD
12020323|NCT00439556|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplantation
12020324|NCT00439556|Biological|Anti-Thymocyte Globulin|Given IV
12020325|NCT00439556|Drug|Bortezomib|Given IV
12020326|NCT00439556|Drug|Carmustine|Given IV
12020327|NCT00439556|Drug|Cytarabine|Given IV
12020328|NCT00439556|Drug|Etoposide|Given IV
12020329|NCT00439556|Biological|Filgrastim|Given SC
12020330|NCT00439556|Drug|Melphalan|Given IV
12020331|NCT00439556|Drug|Methotrexate|Given IV
12020332|NCT00439556|Biological|Rituximab|Given IV
12020333|NCT00439556|Drug|Tacrolimus|Given IV and PO
12020334|NCT00439543|Drug|Iloprost inhalation|
12020335|NCT00439530|Drug|oseltamivir|
12020336|NCT00439530|Drug|probenecid|
12020337|NCT00439517|Drug|UFOX + Cetuximab|"Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
12020338|NCT00439517|Drug|FOLFOX4 + Cetuximab|"Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
12020339|NCT00439504|Drug|Lobeline|
12020340|NCT00439491|Behavioral|Hypocaloric diet|
12020341|NCT00439478|Drug|Radioiodine|
12020342|NCT00439465|Biological|Ex-vivo expanded effector cells|This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
12020343|NCT00439452|Other|Telemedicine-Based Collaborative Care|Off-site depression care team (telephone nurse care manager, telephone pharmacist, tele-psychologist and tele-psychiatrist) works collaboratively with on-site primary care providers. Telephone nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response. Telephone pharmacist activities include documenting medication histories and conducting medication management. Tele-psychologist activities include providing cognitive behavioral therapy via interactive video. Tele-psychiatrist activities include conducting patient consultation via interactive video.
12020344|NCT00439452|Other|Practice Based Collaborative Care|One-site nurse care manager works collaboratively with on-site primary care providers. Nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.
12020345|NCT00439439|Radiation|Beamer Ablation (Argon Plasma Coagulation)|APC-Beamerablation of heterotopic gastric mucosa
12020346|NCT00439426|Drug|Oxaliplatin|130mg/m2 iv on day 1 of each 3 week cycle
12020347|NCT00439426|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-14 of each 3 week cycle
12020348|NCT00439413|Drug|Selegiline Transdermal Patch|Selegiline cm(2) via transdermal system
12020349|NCT00439413|Drug|Placebo|Matching placebo via transdermal system
12020350|NCT00439413|Behavioral|Smoking Cessation Counseling|Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
12020351|NCT00439400|Drug|doxycycline|
12020352|NCT00439400|Drug|placebo|
12020353|NCT00439374|Drug|17 alpha-hydroxyprogesterone caproate|Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
12020354|NCT00439374|Other|Placebo Oil|Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
12020355|NCT00439361|Drug|Bortezomib|1.0 mg/m^2 by Vein Over 5 Seconds on Days 1 and 4
12020356|NCT00439361|Drug|Carboplatin|5 AUC by Vein Over 1 Hour On Day 1
12020357|NCT00439361|Drug|Etoposide|100 mg/m^2 By Vein Over 2 Hours On Days 1-3
12020358|NCT00439361|Drug|Ifosfamide|5 Gm/m^2 By Vein Continuous Infusion Over 24 Hours On Day 1
12020359|NCT00439361|Drug|Mesna|5 mg/m^2 IV continuous Infusion over 24 Hours On Day 1; 2 Gm/m^2 IV continuous infusion over 12 hours starting after completion of Ifosfamide + Mesna 24 hour continuous infusion
12020360|NCT00439348|Behavioral|Verbal advice|Patients receive verbal advice regarding specific over-the-counter medications.
12020361|NCT00439348|Behavioral|Prescription|Patients receive a prescription for a specific over-the-counter medication.
12020362|NCT00439335|Biological|Inactivated Influenza A Vaccine A/H5N1|Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intramuscular (IM) injection. Vaccine will be administered to each subject at Days 0 and 28.
12020363|NCT00439335|Biological|Inactivated Influenza A Vaccine A/H5N1|Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intradermal (ID) injection. Vaccine will be administered to each subject at Days 0 and 28.
12020364|NCT00439335|Drug|Placebo (IM)|The placebo will be 0.1 mL of saline administered by the IM route.
12020365|NCT00439335|Drug|Placebo (ID)|The placebo will be 0.1 mL of saline administered by the ID route.
12020366|NCT00439309|Device|Gelfoam/Thrombin|Gelfoam/Thrombin
12020367|NCT00439309|Device|VascuSeal|VascuSeal
12020417|NCT00438984|Procedure|biopsy|Optional correlative studies
12020418|NCT00438984|Other|laboratory biomarker analysis|Correlative studies
12020419|NCT00438984|Other|immunologic technique|Correlative studies
12020368|NCT00439296|Drug|ABT-751|"Treatment Course 1:
~Oral capsule to be given daily for 21 days at assigned dose.
~Treatment Course 2:
~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.
~Treatment Course 3:
~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest."
12020369|NCT00439296|Drug|Dexamethasone|"In Treatment Course 1 only:
~10 mg/m2/day divided BID.
~Take dexamethasone by mouth days 1-14."
12020370|NCT00439296|Drug|PEG-asparaginase|"In Treatment Course 1:
~2500 IU's/m2/day.
~Intramuscular injection (IM) on days 4, 11 and 18.
~In Treatment Course 2:
~2500 IU's/m2/day.
~Intramuscular injection (IM) on day 15."
12020371|NCT00439296|Drug|Doxorubicin|"In Treatment Course 1 only:
~• 60 mg/m2/day IV over 15 minutes on day 1."
12020372|NCT00439296|Drug|Cytarabine|"Given Intrathecally on day 1 of course 1 at the dose defined by age below.
~30 mg for patients age 1-1.99
~50 mg for patients age 2-2.99
~70 mg for patients >3 years of age
~Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.
~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12."
12020373|NCT00439296|Drug|Methotrexate|"In Treatment Course 1:
~• Given Intrathecally on day 15 at the dose defined by age below.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age
~In Treatment Course 2:
~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age
~In Treatment Course 3:
~Intrathecally on day 1 at the age-defined dose"
12020374|NCT00439296|Drug|Cyclophosphamide|Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.
12020375|NCT00439296|Drug|6-thioguanine|Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.
12020376|NCT00439283|Drug|infliximab|
12020377|NCT00439283|Drug|methotrexate|
12020378|NCT00439270|Drug|Dasatinib|Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression
12020379|NCT00439270|Drug|Docetaxel|Infusion, 60 or 75 mg/m^2, administered every 3 weeks.
12020380|NCT00439244|Drug|Zoledronic acid|Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid.
12020381|NCT00439244|Drug|Placebo|Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to allow an infusion of 100 mL total volume in a ready-to-infuse plastic bottle
12020382|NCT00439244|Drug|Teriparatide|"Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each pre-filled delivery device is filled with 3.3 mL to deliver 3 mL.
~Each mL contains 250 μg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetate acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge pre-assembled into a pen device delivers 20 μg of teriparatide per dose each day for up to 28 days."
12020383|NCT00439231|Drug|Lenalidomide|Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects
12020384|NCT00439218|Drug|sodium phenylbutyrate|500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD.
12020385|NCT00439205|Device|FastEEM4 System|The FastEEM4 probe is moved toward the edge of the lesion(s) until it measures what appears to be normal mouth tissue.
12020386|NCT00439205|Device|Multispectral Digital Microscope|The MDM instrument will take pictures of abnormal-appearing and normal-appearing areas in the mouth.
12020387|NCT00439192|Drug|ELB245|
12020388|NCT00439192|Drug|Tolterodine|
12020389|NCT00439179|Drug|cohort 1|Weekly gem + GW572016, 1000mg/day (combination)
12020390|NCT00439179|Drug|cohort 2|Weekly gem + GW572016, 1500 mg/day (combination)
12020391|NCT00439179|Drug|cohort 3|GEMOX + GW572016 1000 mg/day (combination)
12020392|NCT00439179|Drug|cohort 4|GEMOX + GW572016 1500 mg/day (combination)
12020393|NCT00439166|Drug|doxycycline|capsule, 100 mg, b.i.d., daily for 1 year
12020394|NCT00439166|Drug|rifampicin|capsule, 300mg, o.d., daily for 11 months (administration starts in 2nd month of trial)
12020395|NCT00439166|Drug|Placebo matched to doxycycline|Doxycycline-matched - blue capsule, b.i.d.,daily for 12 months
12020396|NCT00439166|Drug|Placebo matched to Rifampin|Rifampin-matched - red capsule, o.d., daily for 11 months starting at month 2.
12020397|NCT00439153|Device|Tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs|See Detailed Description.
12020398|NCT00439140|Biological|botulinum toxin Type A|Botulinum toxin Type A injection into the detrusor.
12020399|NCT00439140|Drug|Normal Saline (Placebo)|Placebo (Normal Saline) injection into the detrusor.
12020400|NCT00439101|Drug|Megstrol Acetate|Megestrol acetatet 7.5 mg/kg/day orally (lemon-lime suspension) for 90 days.
12020401|NCT00439101|Other|Placebo|Placebo (lemon-lime suspension) taken orally for 90 days.
12020402|NCT00439075|Procedure|CPAP|
12020403|NCT00439075|Drug|standard treatment|
12020404|NCT00439062|Drug|Roxithromycin|
12020405|NCT00439049|Drug|modafinil|400 mg daily
12020406|NCT00439049|Drug|d-amphetamine|60mg daily
12020407|NCT00439049|Drug|L-Dopa|800/200mg daily
12020408|NCT00439049|Drug|Naltrexone|50mg daily
12020409|NCT00439036|Behavioral|Behavior Therapy|The Act-ODT intervention will consist of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.
12020410|NCT00439036|Behavioral|Drug Counseling|
12020411|NCT00439023|Procedure|dialysis with glucose in dialysis water|
12020412|NCT00439010|Drug|[123I] AV 39|
12020413|NCT00438984|Drug|cyclophosphamide|Given IV
12020414|NCT00438984|Biological|therapeutic autologous lymphocytes|Given IV
12020415|NCT00438984|Biological|aldesleukin|Given IV or SC
12020416|NCT00438984|Other|immunohistochemistry staining method|Correlative studies
12020420|NCT00438984|Genetic|polymerase chain reaction|Correlative studies
12020421|NCT00438971|Drug|Duloxetine|Treatment will be initiated at 30mg/day in the first week (week 0), and then increased to 60mg/day at week 1, with the option to increase to 90mg at week 4, and 120mg at week 6.
12020422|NCT00438958|Biological|filgrastim|Given on day 0.
12020423|NCT00438958|Procedure|allogeneic bone marrow transplantation|Given on day 0
12020424|NCT00438958|Procedure|peripheral blood stem cell transplantation|Given on day 0
12020425|NCT00438945|Drug|Eprosartan|
12020426|NCT00438932|Drug|Lanthanum Carbonate|Lanthanum carbonate 1000mg 3x/day
12020427|NCT00438932|Dietary Supplement|Low Phosphorus Diet|Low phosphorus diet will consist of 800 mg of phosphorus per day.
12020428|NCT00438932|Dietary Supplement|Unrestricted Phosphorus Diet|Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
12020429|NCT00438932|Drug|Placebo|Lanthanum Carbonate placebo given three times a day with meals.
12020430|NCT00438919|Device|drug-eluting stent|CYPHER SELECT™ Sirolimus-eluting Coronary Stent
12020431|NCT00438906|Procedure|Biopsy, Fine Needle Aspiration (FNA)|If a pancreatic lesion of concern is identified, a small needle is inserted in the lesion in the pancreas and cells of the lesion are aspirated. Diagnosis of the lesion can typically occur with FNA.
12020432|NCT00438906|Drug|Secretin (human synthetic) - ChiRhoClin|Secretin is a synthetic human hormone that encourages the pancreas to create fluid. This will allow pancreatic juice to be collected via gentle suction in the duodenum where the pancreatic juice naturally flows.
12020433|NCT00438893|Dietary Supplement|Dietary portfolio of cholesterol-lowering foods|A plant based dietary portfolio providing plant sterols (1.0g/1000 kcal), soy protein (22.5g/1000 kcal, viscous fibers 10 g/1000 kcal and almonds 22.5g/1000 kcal)
12020434|NCT00438880|Drug|Agatolimod Sodium|Given IV
12020435|NCT00438880|Radiation|Indium In-111 Ibritumomab Tiuxetan|Given IV
12020436|NCT00438880|Other|Laboratory Biomarker Analysis|Correlative study
12020437|NCT00438880|Procedure|Radionuclide Imaging|Undergo imaging scans
12020438|NCT00438880|Biological|Rituximab|Given IV
12020439|NCT00438880|Procedure|Single Photon Emission Computed Tomography|Undergo imaging scans
12020440|NCT00438880|Radiation|Yttrium Y-90 Ibritumomab Tiuxetan|Given IV
12020441|NCT00438867|Genetic|Ad5FGF-4|Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
12020442|NCT00438867|Genetic|Placebo|Control group
12020443|NCT00438854|Drug|Dasatinib|Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
12020444|NCT00438841|Drug|bortezomib|
12020445|NCT00438841|Drug|cyclophosphamide|
12020446|NCT00438841|Drug|dexamethasone|
12020447|NCT00438841|Drug|thalidomide|
12020448|NCT00438828|Drug|dexamethasone|8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
12020449|NCT00438815|Biological|C1 esterase inhibitor [human] (C1INH-nf)|
12020450|NCT00438802|Drug|Alefacept|Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8
12020451|NCT00438789|Drug|eculizumab|600mg IV every week and 900mg IV every 2 weeks
12020452|NCT00438776|Drug|olanzapine|2.5mg to 15mg daily
12020453|NCT00438776|Drug|sugar pill|matching placebo to olanzapine
12020454|NCT00438750|Other|Independent Excercises|Subjects provided with wrist splint and instructions for independent exercises to perform at home on their own. Subjects were advised to perform exercises as often as possible, but at least three to four times a day for a minimum of thirty minutes. There was no formal strengthening program.
12020455|NCT00438750|Other|Occupational Therapy|Subjects were prescribed formal occupational therapy with supervised exercises to regain digit, wrist, and forearm motion and to strengthen the hand. The content, frequency, and duration of the rehabilitation program were at the discretion of the treating hand therapist.
12020456|NCT00438737|Biological|bevacizumab|
12020457|NCT00438737|Biological|cetuximab|
12020458|NCT00438737|Drug|fluorouracil|
12020459|NCT00438737|Drug|leucovorin calcium|
12020460|NCT00438737|Drug|oxaliplatin|
12020461|NCT00438737|Procedure|adjuvant therapy|
12020462|NCT00438737|Procedure|conventional surgery|
12020463|NCT00438737|Procedure|neoadjuvant therapy|
12020464|NCT00438724|Behavioral|Information, counseling and support|
12020465|NCT00438698|Other|Low Glycemic Index diet|Diet to emphasize carbohydrate foods low in glycemic index
12020466|NCT00438698|Other|High Cereal Fibre Diets|Diet to emphasize whole wheat carbohydrate cgoices
12020467|NCT00438685|Behavioral|Outpatient MST/OPTION-A|
12020468|NCT00438685|Behavioral|Usual Services|
12020469|NCT00438672|Drug|Placebo Injection|Injection without steroid
12020470|NCT00438672|Drug|Steroid (dexamethasone) Injection|Injection with steroid (dexamethasone)
12020471|NCT00438659|Drug|mometasone furoate|Applied to treatment area
12020472|NCT00438659|Other|placebo|Applied to treatment area
12020473|NCT00438620|Behavioral|Home-based physical activity program|the role of physical activity as a Quality of Life intervention
12020474|NCT00438607|Drug|BIIB014|oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
12020475|NCT00438607|Drug|Placebo|Matched placebo for MTD or MTD-1
12020476|NCT00438594|Behavioral|home visitation|Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
12020477|NCT00438581|Drug|Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )|
12020478|NCT00438568|Drug|Regular Insulin|administered intra-nasally twice a day for 16 weeks
12020479|NCT00438568|Drug|Placebo|administered intra-nasally twice a day for 16 weeks
12020480|NCT00438555|Behavioral|Parents and children group|3 months workshops of parents and children intervention, guided by dietician and phycologist
12020481|NCT00438555|Behavioral|Parent's group|3 months workshop of parents intervention, guided by dietician and phycologist
12020482|NCT00438516|Behavioral|nurse home visitation|Nurse home visits from midway through pregnancy to child age 2
12020483|NCT00438503|Procedure|Procedure|
12020484|NCT00438490|Drug|Recombinant Human Prolactin|
12020485|NCT00438477|Drug|Isosulfan Blue|At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.
12020486|NCT00438477|Procedure|Lymphangiography|2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast
12020487|NCT00438477|Radiation|Technetium Tc 99m sulfur colloid|"At least 2 days before scheduled surgery, receive technetium Tc 99m sulfur colloid by peritumoral injection; and again the day before surgery by subareolar injection.
~At the time of surgery, patients receive isosulfan blue by subareolar injection."
12020488|NCT00438464|Drug|Finasteride|Given PO
12020489|NCT00438464|Other|Placebo|Given PO
12020490|NCT00438464|Procedure|Prostatectomy|Undergo prostatectomy
12020491|NCT00438464|Other|Laboratory biomarker analysis|Correlative studies
12020492|NCT00438451|Drug|Levetiracetam|LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance.
12020493|NCT00438451|Drug|Carbamazepine|CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (200 - 1200 mg) during maintenance depending on tolerance and efficacy.
12020494|NCT00438451|Drug|Lamotrigine|LTG 25 mg encapsulated: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 caps. per day (50 - 300 mg)during maintenance depending on tolerance and efficacy.
12020495|NCT00438438|Behavioral|forced desynchrony protocol with sleep restriction|Subjects are scheduled to live on a non-24 hour day. This separates the sleep-wake schedule from the near-24 hour circadian rhythm. This allows assessment of how circadian rhythms and the length-of-time awake contribute to sleepiness, alertness, and cognitive performance.
12020496|NCT00438425|Dietary Supplement|Dietary Portfolio - Intensive|Dietitians advised participants to consume the following therapeutic diet components (<7% of energy saturated fat, <200 mg/d cholesterol) plus the combination of viscous fibers, soy protein, plant sterols and nuts. The portfolio diet plan will include foods which contribute 9.8 g/1000 kcal viscous fiber as B-glucan (oats, barley, oat bran breads and soups) and psylliium (cereal), 0.94 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other meat analogues, milks, yogurts and cheese) and 22.5 g nuts/1000 kcal as part of a low fat vegetarian diet. Participants received 7 visits during a 6-month period with the study dietitian.
12020497|NCT00438425|Dietary Supplement|Dietary Portfolio - Routine|Dietitians advised participants to consume the following therapeutic diet components (<7% of energy saturated fat, <200 mg/d cholesterol) plus the combination of viscous fibers, soy protein, plant sterols and nuts. The portfolio diet plan will include foods which contribute 9.8 g/1000 kcal viscous fiber as B-glucan (oats, barley, oat bran breads and soups) and psylliium (cereal), 0.94 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other meat analogues, milks, yogurts and cheese) and 22.5 g nuts/1000 kcal as part of a low fat vegetarian diet. Participants received 2 visits during a 6-month period with the study dietitian.
12020498|NCT00438425|Dietary Supplement|Control (low saturated fat therapeutic diet)|Dietitians advised participants to consume the following therapeutic diet components (<7% of energy saturated fat, <200 mg/d cholesterol) with a focus on low-fat dairy and whole grain cereals together with fruit and vegetables as part of a low fat vegetarian diet, and avoidance of the specific portfolio components.
12020499|NCT00438399|Drug|C. propionate - Corticosteroid 1|Twice daily application
12020500|NCT00438399|Drug|C. propionate- Corticosteroid 2|Twice daily application
12020501|NCT00438399|Drug|C. propionate -Corticosteroid 3|Twice daily application
12020502|NCT00438399|Drug|Corticosteroid 1- C. propionate|Twice daily application
12020503|NCT00438399|Drug|Corticosteroid 2 - C. propionate|Twice daily application
12020504|NCT00438399|Drug|Corticosteroid 3 - C. propionate|Twice daily application
12020505|NCT00438386|Drug|Aripiprazole|
12020506|NCT00438360|Drug|Cyclosporine A microemulsion|Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations
12020507|NCT00438360|Drug|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
12020508|NCT00438347|Behavioral|Aerobic Exercise|One hour per day three times a week for one year
12020509|NCT00438347|Behavioral|Stretching and toning|One hour per day three times a week for one year
12020510|NCT00438334|Device|Programmable directional/omni-directional hearing aid|
12020511|NCT00438321|Drug|Zoladex|
12020512|NCT00438321|Drug|Testosterone gel|
12020513|NCT00438321|Drug|Anastrozole Pill|
12020514|NCT00438321|Other|Placebo|
12020515|NCT00438295|Procedure|temperature control|
12020516|NCT00438282|Behavioral|home visitation|Home visitation from midway through pregnancy until child age 2. Group 2 is visitation by Paraprofessionals; group 3 is home visitation by Nurses.
12020517|NCT00438269|Drug|Site-specific empiric regimens included: Meropenem|
12020518|NCT00438269|Drug|Piperacillin/tazobactam|
12020519|NCT00438269|Drug|Ciprofloxacin and cefazolin +/- metronidazole|
12020520|NCT00438256|Procedure|Proton Beam Radiation|Given over different schedules and duration
12020521|NCT00438256|Drug|Capecitabine|Given orally starting on day one of radiation therapy for 2 weeks
12020522|NCT00438243|Drug|Bromfenac (Xibrom)|1 drop to affected eye twice daily.
12020523|NCT00438243|Drug|Refresh Plus|1 drop in the affected eye twice daily
12020524|NCT00438230|Drug|Warfarin|
12020525|NCT00438217|Drug|Triptorelin (GnRH agonists)|
12020526|NCT00438217|Drug|Leuprolide (GnRH agonists)|
12020527|NCT00438204|Biological|bevacizumab|Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
12020528|NCT00438204|Drug|gemcitabine hydrochloride|Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
12020529|NCT00438204|Drug|pemetrexed disodium|Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days.
12020530|NCT00438178|Drug|Obatoclax mesylate (GX15-070MS)|
12020531|NCT00438165|Behavioral|home visitation|Home visitation by nurses from midway through pregnancy until child age 12
12020532|NCT00438152|Drug|Saquinavir (Invirase®)|Saquinavir 1000mg + Ritonavir 100mg Bd for 24 weeks
12020533|NCT00438152|Drug|Lopinavir/ritonavir (Kaletra®)|Lopinavir/ritonavir 400/100 mg BD 24 weeks
12020534|NCT00438139|Drug|Dronabinol|
12020535|NCT00438126|Behavioral|A lifestyle educational program|
12020536|NCT00438113|Drug|Aggressive Blood Pressure control|Aggressive Blood Pressure therapy, alone or combination therapy, to reach a target BP equal to or less than 120/80 mmHg
12020537|NCT00438100|Drug|Capecitabine|1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
12020538|NCT00438100|Drug|S-1|80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
12020539|NCT00438087|Drug|methylprednisolone|methylprednisolone administrated intra and post operatively
12020540|NCT00438061|Behavioral|Weight loss by dietary restriction|
12020541|NCT00438048|Procedure|pilocarpine|or secondary symptomatic SS with clinically significant dry mouth were randomized to receive either 5 mg oral Pilocarpine solution (5ml) or artificial saliva (5 ml) 3 times a day for 12 weeks
12020542|NCT00438048|Drug|Artificial Saliva|5ml 3 times daily
12020543|NCT00438035|Procedure|ECG spectral|
12020544|NCT00438009|Drug|Coxsackievirus A21|Two doses of drug, separated by 48 hours
12020545|NCT00437996|Drug|Clonidine|
12020546|NCT00437996|Drug|Levobupivacaine|
12020547|NCT00437996|Drug|Sufentanil|
12020548|NCT00437983|Dietary Supplement|PS-Omega3|Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk
12020549|NCT00437983|Dietary Supplement|Placebo|Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
12020550|NCT00437970|Drug|Pioglitazone|15mg of Pioglitazone taken orally twice a day
12020551|NCT00437970|Drug|Metformin|500 mg of Metformin taken orally twice a day
12020552|NCT00437957|Drug|Temozolomide|75 Mg/m2/day for all Cohorts
12020553|NCT00437957|Drug|Valproic Acid|Cohort 1: 20 mg/kg/day Cohort 2: 30 mg/kg/day Cohort 3: 40 mg/kg/day Cohort 4: 50 mg/kg/day
12020554|NCT00437957|Procedure|Whole Brain Radiation Therapy|Concurrently with Temozolomide and VPA
12020555|NCT00437918|Drug|nateglinide|
12020556|NCT00437918|Drug|acarbose|
12020557|NCT00437905|Procedure|angioplasty|
12020558|NCT00437892|Drug|atorvastatin|tablets, 40 mg day, 3 months
12020559|NCT00437892|Drug|atorvastatin|tablets, 40 mg once daily
12020560|NCT00437892|Behavioral|diet|daily
12020561|NCT00437892|Behavioral|diet|daily diet
12020562|NCT00437853|Drug|Anastrozole|
12020563|NCT00437840|Drug|GSK598809|GSK598809 capsules will be available in dose strength of 5 and 25 mg. Subjects will receive single oral dose of GSK598809 n order to achieve the required dose.
12020564|NCT00437840|Drug|Placebo|Subjects will receive single oral dose of matching placebo tablet to GSK598809.
12020565|NCT00437827|Other|Star*D algorithm|Standard of care based upon the therapies selected in the Star*D study.
12020566|NCT00437827|Other|rEEG-guided therapy|An rEEG report is based upon a process that utilizes a patient's drug-free QEEG to predict successful treatment strategies.
12020567|NCT00437814|Drug|Ketamine, effect on intracranial pressure|
12020568|NCT00437762|Drug|Botulinum Toxin A Injection|Botulinum Toxin A Injection
12020569|NCT00437762|Drug|Placebo injection|Placebo Injection
12020570|NCT00437749|Drug|CBT-1|(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
12020571|NCT00437749|Other|Placebo|(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
12020572|NCT00437736|Drug|APO010|APO010 starting at 2.5 µg/m² IV on D1, D15, D22 and D29 followed by a two-week drug rest.
12020573|NCT00437723|Drug|epoetin beta [NeoRecormon]|At a dose to achieve and maintain an Hb level of 120-135g/dL.
12020574|NCT00437710|Procedure|cell therapy, bone marrow derived stem cell|
12020575|NCT00437697|Drug|dalteparin|
12020576|NCT00437684|Drug|LPV/r|200/50 mg 2 cpr bid monotherapy
12020577|NCT00437684|Drug|PEG-IFNa 2a|PEG-IFNa 2a 180 mcg/week
12020578|NCT00437684|Drug|Ribavirin|Ribavirin 1-1.2 g/day
12020579|NCT00437684|Drug|NUCS|Nucleoside Reverse Transcriptase Inhibitors
12020580|NCT00437671|Drug|Tetanus Immune Globulin (Human)|Based on package insert recommendation and recommendations of WHO
12020581|NCT00437671|Biological|Diphtheria-Tetanus Toxoids Adsorbed|Based on package insert recommendations and recommendations of WHO
12020582|NCT00437658|Drug|Elagolix|Provided as tablets for oral administration
12020583|NCT00437658|Drug|Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)|Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.
12020584|NCT00437658|Drug|Placebo to Elagolix|Matching placebo tablets for oral administration
12020585|NCT00437658|Drug|Placebo to DMPA-SC|Matching placebo for subcutaneous injection in a pre-filled syringe
12020586|NCT00437645|Drug|Valsartan 160 mg capsules|
12020587|NCT00437645|Drug|Amlodipine 5 mg capsules|
12020588|NCT00437645|Drug|placebo|capsules
12020589|NCT00437632|Drug|GSK598809|GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water.
12020590|NCT00437632|Drug|Placebo|Subjects will receive matching placebo capsules to GSK598809 orally with water.
12020591|NCT00437632|Drug|Caffeine|Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.
12020592|NCT00437619|Drug|calcipotriol hydrate [Daivonex]|50 micrograms/g bid for 4 weeks (weeks 5-8) in patients who have shown a >50% response to Daivobet from weeks 0-4.
12020593|NCT00437606|Drug|GK Activator (2)|100mg po
12020594|NCT00437606|Drug|Ethanol|40g po
12020595|NCT00437593|Procedure|ppVE, MP, ICG|surgery with ILM staining
12020596|NCT00437593|Procedure|ppVE, MP, MB|Surgery with ERM staining
12020597|NCT00437580|Drug|Lactobacillus casei rhamnosus (strain Lcr 35 LC)|Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic or to a 5 weeks regimen with placebo.
12020598|NCT00437567|Dietary Supplement|Galacto-oligosaccharide (GOS)|Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.
12020599|NCT00437567|Other|Placebo|Similar quantity of sterile water to be added to milk
12020601|NCT00437541|Device|Insulation retrofitted into house|
12020602|NCT00437502|Biological|tumor peptide vaccine|Cohort 1 low dose level of vaccine @ 0.3 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.
12020603|NCT00437502|Biological|tumor peptide vaccine|Cohort 2 high dose vaccine @ 1 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.
12020604|NCT00437489|Drug|Inhaled Human Insulin (Exubera)|Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
12020605|NCT00437489|Drug|Inhaled Human Insulin (Exubera)|Initial dose of 1mg TID of inhaled human insulin
12020606|NCT00437476|Drug|LPV/r|Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)
12020607|NCT00437476|Drug|Nucleoside Reverse Transcriptase Inhibitors|NRTIs for 26 weeks (A) or 24 weeks (B)
12020608|NCT00437476|Drug|PEG-IFNa 2a|PEG-IFNa 2a 180 mcg/week (48 weeks)
12020609|NCT00437476|Drug|Ribavirin|Ribavirin 1-1.2 g/day (48 weeks)
12020610|NCT00437463|Drug|Ramipril|2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
12020611|NCT00437450|Drug|Epoetin/Atra|
12020612|NCT00437437|Drug|Brivanib|Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression
12020613|NCT00437424|Drug|Brivanib|Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
12020614|NCT00437411|Behavioral|Affective Self-Awareness workshop|Affective Self Awareness intervention: 90 minute face-to-face consultation with the treating physician, then three 2-hour weekly small-group workshops involving education regarding Mind-Body connections, written emotional expression, meditation, and self-affirmation practices.
12020615|NCT00437398|Biological|Islet Transplant|Purified pancreatic islets
12020616|NCT00437385|Drug|TCAs, SSRIs, NARIs, SNRIs, Lithium|Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002)
12020617|NCT00437385|Procedure|Electroconvulsive therapy|ECT treatment is administered three times per week on non-successive weekdays and according to existing standards. Treatment lasts for at least three weeks (nine ECT sessions). Psychopharmacological treatment is continued during ECT treatment. Patients receive ultrabrief pulse (0.3 ms), unilateral treatment at a frequency of 40-100 Hertz. Stimulation is applied to the non-dominant hemisphere, according to the d'Elia electrode positioning paradigm. All patients are initially treated with right unilateral stimulation and in case of non-response switched to bilateral treatment. Stimulus intensity is chosen according to individual seizure threshold and administered at 2.5 to 6-fold intensity. During the ECT session, patients are anesthetized, under the influence of a muscle relaxant, and monitored regarding their vital functions.
12020618|NCT00437385|Behavioral|Cognitive behavioral group therapy|"The continuation-psychotherapy (continuation cognitive behavioral therapy, C-CBT) sample took part in a newly developed cognitive behavioral group therapy program called EffECTive. This therapy program was developed within the EffECT-project (Brakemeier et al. 2005), to fit the specific target group of patients finished with acute ECT-treatment. EffECTive is a group therapy that combines several aspects of existing cognitive-behavioral depression manuals with new elements (e.g., the situational analysis from CBASP, McCullough 2000), to fit the target group. Therapy sessions were held once a week and include approximately 15 sessions until follow-up."
12020619|NCT00437372|Drug|Sunitinib|"The use of the FDA approved drug sunitinib, used in an off-label manner with external beam radiation therapy."
12020620|NCT00437372|Radiation|External Beam Radiation Therapy|Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.
12020621|NCT00437359|Drug|Toremifene citrate|Toremifene citrate: 40-mg tablets by mouth once daily.
12020622|NCT00437359|Drug|Anastrozole|Anastrozole: 1-mg tablets by mouth once daily.
12020623|NCT00437346|Procedure|Individualized and comprehensive information|Thorough verbal and written information about results of the tests. Individualized meals recommendation based on the results.
12020624|NCT00437346|Drug|Lanzo Melt|30mg, od, 1/2 h before meal
12020625|NCT00437346|Drug|Lanzo Melt|30mg, od, 1/2 h before meal
12020626|NCT00437333|Drug|Metformin cloridrate|
12020627|NCT00437320|Procedure|Metvix PDT|Metvix PDT
12020628|NCT00437320|Procedure|placebo|placebo
12020629|NCT00437307|Drug|Topotecan|Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d
12020630|NCT00437294|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease
12020631|NCT00437294|Drug|placebo|oral, daily, 21-day cycles until progressive disease
12020632|NCT00437294|Drug|capecitabine|1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease
12020633|NCT00437281|Drug|Placebo|Placebo
12020634|NCT00437281|Drug|Pregabalin|Orally-administered pregabalin
12020635|NCT00437268|Drug|enzastaurin|1125 milligrams (mg) loading dose, then 500 mg orally, daily, of each 21-day cycle until progressive disease
12020636|NCT00437268|Drug|irinotecan|300 milligrams per square meter (mg/m^2) intravenously on Day 1 of each 21-day cycle until progressive disease
12020637|NCT00437268|Drug|cetuximab|400 mg/m^2, intravenously on Day 1, 250 mg/m^2 on Day 8, Day 15 Cycle 1 then 250 mg/m^2, on Day 1, 8 and 15 of each cycle, intravenously 21-day cycles until progressive disease
12020638|NCT00437255|Drug|Clobetasol Propionate, 0.05%|Topical, twice daily for 4 weeks
12020639|NCT00437255|Drug|Calcipotriene and betamethasone dipropionate ointment|Topical, once daily
12020640|NCT00437242|Drug|Odiparcil|
12020641|NCT00437229|Drug|Casopitant (GW679769) Oral Tablets|Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
12020642|NCT00437229|Drug|dexamethasone|Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
12020643|NCT00437229|Drug|ondansetron|Ondansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes.
12020644|NCT00437216|Drug|Clobetasol Propionate, 0.05%|Apply twice daily for 2 or 4 weeks as monotherapy
12020645|NCT00437216|Drug|Clobetasol propionate, 0.05% Spray|Apply twice daily for 2 or 4 weeks as add-on therapy
12020646|NCT00437203|Drug|PF-00477736|"Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
~If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion."
12020647|NCT00437203|Drug|gemcitabine|gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
12020648|NCT00437190|Device|ATLANTIS™ Cervical Plate System and allograft|Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.
12020649|NCT00437190|Device|BRYAN Cervical Disc Prosthesis|The intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit.
12020650|NCT00437177|Drug|apomorphine|Apomorphine 0.05 mg/kg subcutaneously at hospital admission and at discharge. Abstinent participants at 3 months will receive a third dose.
12020651|NCT00437177|Drug|[(123)I] iodobenzamide|[(123)I] iodobenzamide 185 MBq I.V., at discharge.
12020652|NCT00437164|Drug|Insulin|
12020653|NCT00437164|Drug|Oral GW677954 Capsules (15 mg)|
12020654|NCT00437151|Other|More frequent than normal office visits|Mode of patient reminder
12020655|NCT00437151|Other|Electronic reminders (voice, e-mail, text messages)|Mode of patient reminder
12020656|NCT00437151|Other|Parenteral involvement / intervention reminders|Mode of patient reminder
12020657|NCT00437151|Other|No intervention or reminders|Mode of patient reminder
12020658|NCT00437138|Behavioral|Exposure to dilute diesel exhaust (300µg/m3) or filtered air|
12020659|NCT00437125|Drug|Duloxetine hydrochloride|Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks
12020660|NCT00437112|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 24 weeks
12020661|NCT00437112|Drug|Insulin Glargine|patient specific dose, injectable, before meals, 24 weeks
12020662|NCT00437099|Drug|Omacor®|arm 1: Omacor 1680 Arm 2: Omacor 3360
12020663|NCT00437099|Drug|Placebo|Placebo
12020664|NCT00437086|Drug|PS-341|1.6 mg/m2 by IV; 4 out of 5 weeks
12020665|NCT00437073|Drug|capecitabine|capecitabine 2000mg/m2/day orally, Days 1-14, every 21 days
12020666|NCT00437073|Drug|topotecan|topotecan intravenous (IV, in the vien) 3.2mg/m2 Days 1, 8 and 15; every 28 days
12020667|NCT00437073|Drug|lapatinib|lapatinib administered 1250mg once daily orally
12020668|NCT00437060|Procedure|Cognitive Assessment|Ancillary studies
12020669|NCT00437060|Procedure|Diffusion Tensor Imaging|Correlative studies
12020670|NCT00437060|Other|Laboratory Biomarker Analysis|Correlative studies
12020671|NCT00437060|Other|Pharmacological Study|Correlative studies
12020672|NCT00437060|Procedure|Psychosocial Assessment and Care|Ancillary studies
12020673|NCT00437034|Biological|aflibercept|Given IV
12020674|NCT00437021|Drug|Placebo (subcutaneous)|0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia [Sterile Saline Placebo (SSP)].
12020675|NCT00437021|Drug|Placebo (scarification)|Physiologic normal saline for injection.
12020676|NCT00437021|Biological|Dryvax®|Dryvax® Vaccinia Vaccine (~10^5 [plaque forming units (pfu)/dose] given via scarification, titer 10^8 pfu per mL after reconstitution).
12020677|NCT00437021|Biological|IMVAMUNE®|IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
12020678|NCT00437008|Drug|Benfotiamine 1050mg, 3 days|
12020679|NCT00437008|Behavioral|high-AGE vs. low-AGE meal|
12020680|NCT00436995|Drug|Darbepoetin Alfa|Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.
12020681|NCT00436982|Device|Cemented Triathlon total knee system|Orthopaedic implant
12020682|NCT00436982|Device|Duracon total knee system|Orthopaedic implant
12020683|NCT00436969|Device|Orthovisc|Orthovisc injection
12020684|NCT00436969|Drug|Control|Celestone (betamethasone sodium phosphate and acetate) - 2 mL
12020685|NCT00436956|Procedure|Magnetic Resonance Imaging (DCE-MRI)|Scans evaluate tumor tissue and blood flow.
12020686|NCT00436956|Drug|AZD2171|20 mg oral daily for 28 days
12020687|NCT00436956|Drug|Prednisone|10mg orally daily in combination with AZD2171 20mg daily.
12020688|NCT00436943|Drug|nicotine replacement therapy and bupropion|3-6 months
12020689|NCT00436943|Behavioral|smoking cessation counseling and referrals|Organizational counseling and referrals
12020690|NCT00436930|Biological|autologous tumor cell vaccine|Given subcutaneously
12020691|NCT00436930|Biological|sargramostim|Given subcutaneously
12020692|NCT00436930|Biological|therapeutic autologous dendritic cells|Given subcutaneously
12020693|NCT00436917|Drug|zoledronic acid|zoledronic acid
12020694|NCT00436917|Procedure|Letrozole as adjuvant therapy|standard care
12020695|NCT00436904|Drug|Alemtuzumab|30 mg Monday, Wednesday, and Friday x 5 weeks
12020696|NCT00436904|Drug|Rituximab|375mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
12020697|NCT00436878|Behavioral|Food portion size|Each of four experiments involves a 2 x 2 within-subjects factorial design, in which the first factor is the portion size of a food served to children: foods will be served in a reference amount (i.e. 250 g macaroni and cheese) or doubled in size(i.e. 500 g of macaroni and cheese). In the Experiment 1, the second factor of the 2 x 2 design is meal type: whether the food is consumed at a meal or a snack. In experiment #2, the second factor is food type: fruit vs. vegetable. In experiment #3, the second factor is entree energy density: a regular energy density or a 40% greater energy density. In experiment #4, the second factor is plate size: a 6 inch plate vs. a 10 inch plate.
12020698|NCT00436865|Behavioral|Weight loss|
12020699|NCT00436852|Drug|ABT-751|Given orally
12020700|NCT00436852|Procedure|quality-of-life assessment|Ancillary studies
12020701|NCT00436839|Drug|Docetaxel|75mg/m² intravenously (day 1) every 21 days
12020702|NCT00436839|Drug|Mitoxantrone|12mg/m² intravenously every 21 days
12020703|NCT00436839|Drug|Prednisone|10mg orally given daily
12020704|NCT00436826|Drug|Cladribine|Participants were administered with cladribine tablets orally as cumulative dose.
12020705|NCT00436826|Drug|Placebo|Participants were administered with placebo orally.
12020706|NCT00436826|Drug|Interferon-beta (IFN-beta)|Participants received IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during both DB period of 96 weeks and OL extension period of 48 weeks.
12020707|NCT00436800|Drug|Gemcitabine|1000mg/m² over 10mg/m²/min
12020708|NCT00436800|Drug|Oxaliplatin|100 mg/m² over 2 hours.
12020709|NCT00436787|Drug|Fondaparinux Sodium|
12020710|NCT00436774|Procedure|assessment of therapy complications|
12020711|NCT00436774|Procedure|quality-of-life assessment|
12020712|NCT00436761|Biological|anti-thymocyte globulin|
12020713|NCT00436761|Biological|graft-versus-tumor induction therapy|
12020714|NCT00436761|Biological|sargramostim|
12020715|NCT00436761|Drug|busulfan|
12020716|NCT00436761|Drug|cyclosporine|
12020717|NCT00436761|Drug|melphalan|
12020718|NCT00436761|Drug|methylprednisolone|
12020719|NCT00436761|Other|flow cytometry|
12020720|NCT00436761|Other|immunologic technique|
12020721|NCT00436761|Other|laboratory biomarker analysis|
12020722|NCT00436761|Procedure|allogeneic hematopoietic stem cell transplantation|
12020723|NCT00436761|Procedure|umbilical cord blood transplantation|
12020724|NCT00436748|Drug|Darbepoetin Alfa|Administered by subcutaneous or intravenous injection
12020725|NCT00436748|Drug|Placebo|Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
12020726|NCT00436722|Drug|ATG (Fresenius Biotech)|ATG-Fresenius 9 mg/kg at induction
12020727|NCT00436709|Biological|bevacizumab|
12020728|NCT00436709|Biological|pegfilgrastim|
12020729|NCT00436709|Drug|cyclophosphamide|
12020730|NCT00436709|Drug|doxorubicin hydrochloride|
12020731|NCT00436709|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12020732|NCT00436709|Other|flow cytometry|
12020733|NCT00436709|Other|immunoenzyme technique|
12020734|NCT00436709|Other|immunologic technique|
12020735|NCT00436709|Other|laboratory biomarker analysis|
12020736|NCT00436709|Procedure|adjuvant therapy|
12020737|NCT00436709|Procedure|immunoscintigraphy|
12020738|NCT00436696|Other|Laboratory Biomarker Analysis|Correlative studies
12020739|NCT00436683|Drug|Fermagate|Film coated tablet 500mg
12020740|NCT00436683|Drug|Sevelamer HCl|tablet 800mg
12020741|NCT00436670|Biological|AMG 317 75 mg|75 mg SC weekly injection
12020742|NCT00436670|Biological|AMG 317 150 mg|150 mg SC once weekly injection
12020743|NCT00436670|Biological|AMG 317 300 mg|300 mg weekly SC injection
12020744|NCT00436670|Biological|Placebo|Placebo SC once weekly injection
12020745|NCT00436657|Drug|CHPP of Cisplatin|Starting dose of 100 mg/m^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.
12020746|NCT00436657|Procedure|Abdominal Surgery|Surgical removal of abdominal tumors.
12020747|NCT00436644|Drug|Lapatinib|1250 mg orally days 1 -28.
12020748|NCT00436644|Drug|Topotecan|3.2 mg/m2 IV over 30 min in 100mL D5W (5% dextrose in water) or 0.9% NS at days 1, 8 & 15.
12020749|NCT00436631|Behavioral|Dietary management of seizures|Using the high-fat, low carbohydrate modified Atkins diet - 15 grams per day initially. This is a 3-month study of this diet.
12020750|NCT00436618|Drug|Everolimus|Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
12020751|NCT00436605|Drug|dasatinib|
12020752|NCT00436592|Device|NeuroFlo™ Catheter|45 minute Treatment
12020753|NCT00436579|Drug|sorafenib tosylate|Given orally
12020754|NCT00436579|Other|pharmacological study|
12020755|NCT00436579|Procedure|assessment of therapy complications|Ancillary studies
12020756|NCT00436579|Other|laboratory biomarker analysis|Correlative studies
12020757|NCT00436566|Biological|trastuzumab|
12020758|NCT00436566|Drug|cyclophosphamide|
12020759|NCT00436566|Drug|doxorubicin hydrochloride|
12020760|NCT00436566|Drug|lapatinib ditosylate|
12020761|NCT00436566|Drug|paclitaxel|
12020762|NCT00436566|Genetic|gene expression analysis|
12020763|NCT00436566|Genetic|reverse transcriptase-polymerase chain reaction|
12020764|NCT00436566|Other|fluorophotometry|
12020765|NCT00436566|Other|laboratory biomarker analysis|
12020766|NCT00436566|Other|mass spectrometry|
12020767|NCT00436566|Procedure|adjuvant therapy|
12020768|NCT00436566|Procedure|quality-of-life assessment|
12020769|NCT00436553|Drug|Verteporfin Photodynamic Therapy|After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 (Standard Fluence rate) or 25 J/cm^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
12020770|NCT00436553|Drug|Ranibizumab|Ranibizumab 0.5 mg administered as an intravitreal injection.
12020771|NCT00436553|Drug|Verteporfin Placebo|To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.
12020772|NCT00436553|Drug|Ranibizumab Placebo|To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.
12020773|NCT00436540|Drug|Clobetasol Propionate 0.05% Spray|Apply to affected areas twice daily
12020774|NCT00436540|Drug|Clobetasol Propionate 0.05% Foam|Apply to affected areas twice daily
12020775|NCT00436527|Drug|Metronidazole gel 1%|Applied once to a test site on the right or left cheek (as determined by a randomization design)
12020776|NCT00436514|Behavioral|diet and absorption of ColoPEG|4l of PEG during 2 days
12020777|NCT00436514|Procedure|Colonoscopy with colic videocapsule|2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative)
12020778|NCT00436514|Procedure|Standard colonoscopy|1l of PEG the morning just before colonoscopy
12020779|NCT00436501|Drug|docetaxel|25 mg/m^2 given intravenously (IV) over 1 hour (+/- 10 minutes) following VEGF Trap every 3 weeks starting cycle 1 (21 day cycles)
12020780|NCT00436501|Biological|ziv-aflibercept|Starting dose 2 mg/kg given IV Cycle 0. Phase I Group: Every 3 weeks beginning with Cycle 0 (Completed 03/14/2008); Phase II Group: Every 3 weeks starting cycle 1 (Opened 05/09/2008).
12020781|NCT00436501|Other|laboratory biomarker analysis|Correlative studies
12020782|NCT00436501|Other|pharmacological study|Correlative studies
12020783|NCT00436475|Drug|Vitamin D3 2,000 IU orally once daily|Vitamin D3 2,000 IU orally once daily
12020784|NCT00436475|Drug|Calcium Carbonate 400 mg orally twice daily|Calcium Carbonate 400 mg orally twice daily
12020785|NCT00436475|Drug|Vitamin D3-Placebo|Vitamin D3-Placebo
12020786|NCT00436475|Drug|Calcium-Placebo|Calcium-Placebo
12020787|NCT00436449|Drug|Avotermin|
12020788|NCT00436436|Drug|O6-benzylguanine|
12020789|NCT00436436|Drug|temozolomide|
12020790|NCT00436423|Drug|gemcitabine, TS-1|
12020791|NCT00436410|Biological|colloidal gold-bound tumor necrosis factor|
12020792|NCT00436410|Other|electron microscopy|
12020793|NCT00436410|Other|pharmacological study|
12020794|NCT00436410|Procedure|conventional surgery|
12020795|NCT00436397|Radiation|radiation therapy|
12020796|NCT00436384|Procedure|Monitoring-blood samples drawn for CMV testing|
12020797|NCT00436371|Drug|Amisulpride|Oral tablets
12020798|NCT00436358|Other|Not applicable: none|Please refer to the detailed description section
12020799|NCT00436345|Drug|Remifentanil|analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
12020800|NCT00436345|Drug|Propofol|conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
12020801|NCT00436332|Biological|bevacizumab|
12020802|NCT00436332|Drug|erlotinib hydrochloride|
12020803|NCT00436319|Procedure|Duration of GnRH agonist downregulation|"This is a randomized controlled trial. Patients will be randomized to two groups during the first consultation. GnRH agonist will be administrated according to the long luteal protocol. Down-regulation of the pituitary will be controlled on the first day of the menstrual period.
~The purpose of this study is to compare the pregnancy rates between the two groups. In the eventuality that pituitary down-regulation has not been confirmed (down-regulation levels determined as Ε2<80 pg/ml and progesterone <1.6 ng/ml), the patient will be assigned to a third group (group 3) and ovarian stimulation will only be initiated after down-regulation has been confirmed.
~The GnRH agonist that will be administrated is Buserelin Acetate. Recombinant FSH will be used for the ovarian stimulation and dose determination will be based on patient characteristics and previous history."
12020804|NCT00436306|Behavioral|Individualized Intervention|Individualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention.
12020805|NCT00436306|Behavioral|Computer-based contraceptive information|Contraceptive method information is provided on a computer.
12020806|NCT00436293|Drug|Docetaxel|75 mg/m²
12020807|NCT00436293|Drug|Cisplatin|75 mg/m²
12020808|NCT00436280|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
12020809|NCT00436280|Drug|gemcitabine|1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
12020810|NCT00436280|Drug|rituximab|375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
12020811|NCT00436280|Drug|oxaliplatin|100 mg/m², IV, once every two weeks, four to eight 2 week cycles
12020812|NCT00436267|Drug|fluorouracil|
12020813|NCT00436267|Radiation|selective external radiation therapy|
12020814|NCT00436267|Radiation|tomotherapy|
12020815|NCT00436267|Radiation|yttrium Y 90 glass microspheres|
12020816|NCT00436267|Radiation|yttrium Y 90 resin microspheres|
12020817|NCT00436254|Biological|pNGVL3-hICD vaccine|Plasmid-based DNA vaccine, given intradermally
12020818|NCT00436254|Biological|sargramostim|Given intradermally
12020819|NCT00436254|Other|flow cytometry|Correlative studies
12020820|NCT00436254|Other|immunologic technique|Correlative studies
12020821|NCT00436254|Other|immunoenzyme technique|Undergo ELIspot (correlative studies)
12020822|NCT00436254|Genetic|protein expression analysis|Undergo ELISA (correlative studies)
12020823|NCT00436254|Procedure|biopsy|Undergo punch biopsy (correlative studies)
12020824|NCT00436241|Drug|Oxaliplatin|85mg/m2 iv on day 1 of each 2 week cycle
12020825|NCT00436241|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-10 of each 2 week cycle
12020826|NCT00436215|Drug|Bevacizumab|bevacizumab 5 mg/kg intravenous (IV) every two weeks
12020827|NCT00436215|Drug|BAY 43-9006|BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
12020828|NCT00436202|Behavioral|Iron supplement|
12020829|NCT00436189|Procedure|Blood Draw|
12020830|NCT00436176|Behavioral|Expanded Chronic Care Model|Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.
12020831|NCT00436163|Drug|Peginterferon alfa-2a|180 mcg subcutaneously once per week for 48 weeks.
12020832|NCT00436150|Behavioral|Interpersonal therapy-based treatment|Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Both groups will attend weekly 1-hour sessions for 5 weeks.
12020833|NCT00436150|Behavioral|Standard care|Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks.
12020834|NCT00436137|Behavioral|Patient mailing|Patient will receive a mailing recommending colonoscopy, followed by telephone outreach
12020835|NCT00436124|Drug|oseltamivir [Tamiflu]|
12020836|NCT00436098|Behavioral|Motorpedagogic exercise|physical training
12020837|NCT00436085|Behavioral|Cognitive behavioral stress management training|
12020838|NCT00436072|Drug|ZD6474|Orally on a daily basis
12020839|NCT00436072|Drug|Cetuximab|Infusion once weekly
12020840|NCT00436072|Drug|Irinotecan|Infusion once the safe dose of ZD6474 and cetuximab is established
12020841|NCT00436059|Drug|bortezomib|
12020842|NCT00436046|Biological|Trivalent inactivated influenza virus vaccine (2006-2007 formulation)|Commercially available trivalent inactivated influenza virus vaccine without or with 1 of 2 dosages of commercially available type 1 interferon administered once by nasal instillation. Dosages: 0.6 ml of IVV or 0.7 ml of IVV.
12020843|NCT00436046|Biological|Type 1 interferon|Commercially available lyophilized IFN; dosages 1 M unit (Mu) of IFN; 10 M units (Mu) of IFN.
12020844|NCT00436033|Drug|milnacipran|
12020845|NCT00436033|Drug|Placebo|
12020846|NCT00436020|Device|TMS|Transcranial Magnetic Stimulation
12020847|NCT00436020|Device|Sham TMS|Sham Transcranial Magnetic Stimulation
12020848|NCT00436007|Biological|GSK 257049|GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine
12020849|NCT00436007|Biological|Tritanrix™ HepB/Hib|GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™)
12020850|NCT00436007|Biological|Rouvax™|Aventis Pasteur's attenuated measles vaccine.
12020851|NCT00436007|Biological|Stamaril™|Aventis Pasteur's attenuated yellow fever vaccine.
12020852|NCT00436007|Biological|Polio Sabin™|GSK Biologicals' oral polio virus vaccine
12020853|NCT00435994|Drug|Inhaled primatene will be given as a breathing treatment|While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.
12020854|NCT00435994|Other|Nasal Washing|1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence
12020855|NCT00435981|Drug|rhGAD65 formulated in Alhydrogel® (Diamyd®)|
12020856|NCT00435968|Drug|CVT E002 (Cold-fX)|
12020857|NCT00435955|Procedure|High dose chemotherapy with autologous transplantation|
12020858|NCT00435955|Drug|Rituximab|
12020859|NCT00435942|Device|Relay Thoracic Stent-Graft|implant
12020860|NCT00435942|Procedure|Open Repair|Open surgery
12020861|NCT00435929|Drug|Ritonavir|100mg po bid
12020862|NCT00435929|Drug|saquinavir [Invirase]|1000mg po bid
12020863|NCT00435916|Drug|SGN-40|1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.
12020864|NCT00435903|Device|Palm Pilot|
12020865|NCT00435890|Behavioral|Triage Liaison Physician|triage liaison physician stationed with nurses at the triage desk of the Emergency Department.
12020866|NCT00435864|Procedure|Blood test|The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.
12020867|NCT00435851|Drug|Thyrogen, thyroid hormone withdrawal, iode 131|
12020868|NCT00435838|Drug|No Intervention -- Observational study|
12020869|NCT00435825|Drug|peginterferon alfa-2a [Pegasys]|90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
12020870|NCT00435812|Biological|HEPLISAV and/or Placebo|Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
12020871|NCT00435812|Biological|Engerix-B|Intramuscular (IM) injections on Week 0, Week 4, and Week 24
12020872|NCT00435799|Procedure|corneal cross-linking (CCL)|
12020873|NCT00435799|Drug|Riboflavin/dextran eyedrops|
12020874|NCT00435799|Device|UV-X system|
12020875|NCT00435773|Procedure|Single Leeching|
12020876|NCT00435773|Procedure|Repeated Leeching after 4 weeks|
12020877|NCT00435773|Procedure|Placebo Leeching|
12020878|NCT00435760|Drug|Aclidinium bromide|200 micrograms, once daily, 1 day treatment
12020879|NCT00435760|Drug|Placebo Tiotropium|1 puff once daily, 1 day treatment
12020880|NCT00435760|Drug|Tiotropium|1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00
12020881|NCT00435760|Drug|Placebo LAS34273|1 puff, 1 dat treatment
12020882|NCT00435747|Drug|PARECOXIB SODIUM|
12020883|NCT00435734|Behavioral|obesity intervention|
12020884|NCT00435721|Behavioral|Psychoeducation|
12020885|NCT00435708|Behavioral|5 portions fruit and vegetables/day|Participants consume > = 5 portions fruit and veg per day
12020886|NCT00435695|Drug|GSK163090|
12020887|NCT00435682|Drug|Botox (Allergan Inc., US)|
12020888|NCT00435669|Drug|Brivanib|Oral Solution, Oral, 800 mg, X1 on Day 1, 10 D for ADME
12020889|NCT00435669|Drug|Brivanib|Tablet, Oral, Brivanib 800 mg, QD, until progression
12020890|NCT00435643|Procedure|nasal continuous positive airway pressure|After an average interval of three months, 10 patients with severe OSAS (AHI of more than 30 events per hour of sleep) treated with a mean nCPAP pressure of 11.2 ± 0.7 cm of H2O were reassessed and all mentioned measurements above were repeated
12020891|NCT00435630|Other|LapSim training|complete curriculum training on LapSim surgical simulator
12020892|NCT00435617|Device|Hand Mentor|Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.
12020893|NCT00435604|Drug|Hylenex|
12020894|NCT00435591|Drug|Conivaptan|ampoule or premix bag
12020895|NCT00435591|Drug|placebo|ampoule or premix bag
12020896|NCT00435578|Drug|Glufosfamide|
12020897|NCT00435552|Procedure|Ease-It Spray|
12020898|NCT00435539|Drug|ocriplasmin|Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
12020899|NCT00435539|Drug|ocriplasmin|Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
12020900|NCT00435539|Drug|Sham Comparator|Intravitreal sham injection
12020901|NCT00435526|Biological|anti-CFA/I bovine IgG, and anti-CfaE bovine IgG|
12020902|NCT00435500|Drug|Fluoride varnish|
12020903|NCT00435487|Drug|Dalteparin ( Fragmin)|Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.
12020904|NCT00435487|Drug|Unfractionated heparin|Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg [units per kilogram] and initial infusion of 12 U/kg/h [units per kilogram per hour]).
12020905|NCT00435474|Procedure|Wound treatment|wound treatment (silver product, alginate and foam dressing)
12020906|NCT00435474|Procedure|wound treatment|wound treatment (honey product, alginate and foam dressing)
12020907|NCT00435474|Other|psycho-social support|psycho-social support (based on the structure in cognitive therapy)
12020908|NCT00435474|Other|relaxation therapy|relaxation therapy
12020909|NCT00435461|Drug|Fluticasone furoate and fexofenadine|Fluticasone furoate and fexofenadine
12020910|NCT00435448|Drug|Lonidamine|
12020911|NCT00435435|Drug|Disulfiram|
12020912|NCT00435435|Drug|Acamprosate|
12020913|NCT00435435|Drug|Naltexone|
12020914|NCT00435422|Procedure|Stroke volume optimization|Stroke volume optimization
12020915|NCT00435409|Drug|Sunitinib + Capecitabine|"Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.
~Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons."
12020916|NCT00435409|Drug|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day [1250 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.
12020917|NCT00435396|Biological|GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A|Intramuscular injection, 3 doses
12020918|NCT00435370|Drug|Tropisetron|10 mg/day
12020919|NCT00435370|Drug|Placebo|placebo
12020920|NCT00435370|Drug|Risperidone|6mg/day
12020921|NCT00435357|Device|mobile-bearing TKA|
12020922|NCT00435357|Device|fixed- bearing TKA|
12020923|NCT00435344|Behavioral|Pediatric Practice-Based Smoking Intervention|
12020924|NCT00435331|Drug|sapropterin dihydrochloride (6R-BH4)|2.5 mg/kg/day for two weeks, 5 mg/kg/day for two weeks, 10 mg/kg/day for four weeks, then 20 mg/kg/day for two days
12020925|NCT00435318|Procedure|Iontophoresis|
12020926|NCT00435305|Drug|Meropenem|
12020927|NCT00435305|Drug|Vancomycin|
12020928|NCT00435305|Drug|Linezolid|
12020929|NCT00435305|Drug|Piperacillin/Tazobactam|
12020930|NCT00435305|Drug|Cefepim|
12020931|NCT00435305|Drug|Ceftazidim|
12020932|NCT00435292|Drug|Naproxen|nonsteroidal anti-inflammatory drug
12020933|NCT00435292|Dietary Supplement|flavocoxid 250 mg|flavonoid mixture
12020934|NCT00435292|Dietary Supplement|flavocoxid 500 mg|flavonoid mixture
12020935|NCT00435279|Drug|Eszopiclone|Eszopiclone 3 mg
12020936|NCT00435279|Drug|Placebo|Placebo
12020937|NCT00435279|Drug|Venlafaxine|Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
12020938|NCT00435266|Procedure|Remote ischemic preconditioning|Inflation of blood pressure cuff 4 x 5 minutes during transportation to primary PCI
12020939|NCT00435253|Biological|BLVR Treatment|BLVR Treatment, 10 mL Hydrogel
12020940|NCT00435240|Behavioral|Paleolithic diet|
12020941|NCT00435227|Biological|MEDI-524|30 mg/kg of MEDI-524
12020942|NCT00435227|Other|Placebo|30 mg/kg of Placebo
12020943|NCT00435188|Behavioral|Multi-component physical activity counseling program|A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
12020944|NCT00435175|Drug|estradiol|
12020945|NCT00435162|Drug|Valsartan 0.25 mg/kg|once daily
12020946|NCT00435162|Drug|Valsartan 1.0 mg/kg|once daily
12020947|NCT00435162|Drug|Valsartan 4.0 mg/kg|once daily
12020948|NCT00435149|Procedure|Carpal tunnel release surgery|Patient will have carpal tunnel release surgery and will be put in a splint after surgery.
12020949|NCT00435149|Procedure|Carpal tunnel release surgery|Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.
12020950|NCT00435123|Dietary Supplement|Nutritional Supplement ProStat 64 twice a day|
12020951|NCT00435123|Dietary Supplement|Placebo supplement|Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months
12020952|NCT00435110|Procedure|standard ventilatory settings|
12020953|NCT00435110|Procedure|PEEP and FiO2|
12020954|NCT00435084|Drug|APO866|
12020955|NCT00435071|Procedure|Carpal Tunnel Release Surgery|Patient will have large incision size during carpal tunnel release surgery.
12020956|NCT00435071|Procedure|Carpal tunnel release surgery|Patient will have a small incision size during carpal tunnel release surgery.
12020957|NCT00435058|Drug|timolol maleate 0,5%|
12020958|NCT00435058|Drug|brimonidine tartrate 0,2%|
12020959|NCT00435058|Drug|travoprost 0,004%|
12020960|NCT00435045|Drug|Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin|Lovaza + atorvastatin
12020961|NCT00435045|Drug|atorvastatin|atorvastatin + placebo
12020962|NCT00435032|Procedure|early appendectomy|Appendectomy within 24 hours of admission
12020963|NCT00435032|Procedure|interval appendectomy|Initial antibiotic treatment followed by appendectomy at 6-8 weeks
12020964|NCT00435019|Drug|insulin detemir|s.c. injection, once or twice daily.
12020965|NCT00435019|Drug|insulin NPH|s.c. injection, once or twice daily.
12020966|NCT00435019|Drug|insulin aspart|s.c. injection, at main meals.
12021570|NCT00430716|Drug|Sildenafil citrate|oral 20 mg, tid
12020967|NCT00434993|Drug|Albuterol Sulfate|"Albuterol sulfate, USP, solution for inhalation will be diluted as follows:
~The full dose of 5.0 mg will be diluted into 2.0 ml of sterile normal saline solution.
~The reduced dose of 2.5 mg will be diluted into 2.5 ml of sterile normal saline solution.
~A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization. The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first."
12020968|NCT00434993|Procedure|Mini-Bronchoalveolar Lavage (BAL)|The mini-BAL procedure involves blind specimen sampling from distal airspaces. Specimens are obtained with the Combicath (Plastimed) catheter. The procedure will be done on study days 0 and 3
12020969|NCT00434993|Drug|Placebo|"Placebo aerosol will consist of 3.0 ml of identical appearing sterile 0.9 % sodium chloride without preservative.
~A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization (e.g.: throughout the inspiratory and expiratory cycle).
~The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first."
12020970|NCT00434980|Behavioral|Family-Directed Cognitive Adaptation Program|
12020971|NCT00434967|Drug|Candesartan cilexetil|32 mg oral tablet
12020972|NCT00434967|Drug|Hydrochlorothiazide|25 mg oral tablet
12020973|NCT00434967|Drug|Candesartan/HCT 32/25 mg|
12020974|NCT00434954|Drug|exenatide twice daily (BID)|subcutaneous injection (5 mcg or 10 mcg), twice a day
12020975|NCT00434954|Drug|premixed insulin aspart twice daily (BID)|subcutaneous injection (titrated appropriately), twice a day
12020976|NCT00434941|Drug|Capecitabine|
12020977|NCT00434941|Radiation|Radiotherapy|
12020978|NCT00434915|Drug|DHEA|
12020979|NCT00434876|Drug|Quetiapine XR|Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder.
12020980|NCT00434876|Drug|Placebo.|Inactive or inert pill which will be used as a comparator.
12020981|NCT00434863|Drug|botulinum toxin type A|
12020982|NCT00434850|Biological|Allogeneic Pancreatic Islet Cells|Preparation of allogeneic pancreatic islet cells injected into the portal vein of the liver
12020983|NCT00434850|Drug|Deoxyspergualin|An anti-inflammatory agent that blocks proinflammatory cytokine production and inhibits T-cells and B-cells and affects antigen presenting cells.
12020984|NCT00434850|Biological|Antithymocyte globulin|Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
12020985|NCT00434850|Biological|Daclizumab or basiliximab|Will replace antithymocyte globulin in all islet transplantations after the first one
12020986|NCT00434850|Drug|Sirolimus|Maintenance immunosuppressive therapy
12020987|NCT00434850|Drug|Tacrolimus|Maintenance immunosuppressive therapy
12020988|NCT00434850|Biological|Etanercept|Blocks TNF-alpha which is toxic to islet cells
12020989|NCT00434837|Procedure|Initial graft tension during ACL reconstruction surgery|"The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the High Tension treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the Low Tension treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown."
12020990|NCT00434824|Drug|Oral testosterone undecanoate (Andriol)|treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses
12020991|NCT00434824|Drug|Placebo|treatment for 12 months with placebo in divided doses
12020992|NCT00434811|Biological|Allogeneic Pancreatic Islet Cells|200 ml suspension of allogenic human purified islets
12020993|NCT00434811|Biological|Antithymocyte Globulin|Participants will begin receiving ATG 2 days prior to the first islet transplant. ATG will continue to be given until Day 2 post-transplant.
12020994|NCT00434811|Drug|Sirolimus|Participants will begin receiving sirolimus 2 days prior to the first islet transplant and will be given for the duration of the study.
12020995|NCT00434811|Drug|Tacrolimus|On Day 1 post-transplant, participants will receive tacrolimus, which will also be taken for the duration of the study.
12020996|NCT00434811|Biological|Etanercept|Etanercept will be taken on the day of transplant and Days 3, 7, and 10 post-transplant.
12020997|NCT00434811|Procedure|Islet Transplantation|Transplantation of pancreatic islet cell
12020998|NCT00434811|Biological|Basiliximab|Basiliximab will be used in place of ATG for the second and third transplants, if they are necessary.
12020999|NCT00434798|Biological|Campylobacter jejuni strains CG8421 and BH-01-0142|Campylobacter jejuni strains CG8421 and BH-01-0142 at a single dose. Dosing will be based on attack rate, to achieve a 75% attack rate. Anticipate use of 10^6-10^9 CFU
12021000|NCT00434785|Drug|AGG-523|
12021001|NCT00434772|Drug|glucagon|
12021002|NCT00434759|Behavioral|cognitive therapy|changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments
12021003|NCT00434759|Behavioral|stepped care program based on cognitive therapy|starting with a digital-video-disk-based (DVD-based) self-help module (8 Sessions) followed by face-to-face-therapy including 8 or 16 sessions depending on remission status; including: changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments
12021004|NCT00434746|Drug|ILV-094|Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo
12021005|NCT00434733|Biological|Pandemic influenza vaccine|
12021006|NCT00434720|Device|GlideScope Specific Stylet|
12021007|NCT00434694|Procedure|Pulmonary Vein Isolation (Radiofrequency Catheter Ablation)|
12021008|NCT00434681|Drug|paracetamol 4.8% paediatric oral suspension|
12021009|NCT00434668|Drug|cisplatin/docetaxel|
12021010|NCT00434668|Drug|cisplatin/vinorelbine|
12021011|NCT00434655|Procedure|Laparoscopic restrictive procedure|Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
12021012|NCT00434642|Drug|Carboplatin|Carboplatin was provided as commercially available drug.
12021013|NCT00434642|Drug|Gemcitabine|Gemcitabine was provided as commercially available drug.
12021014|NCT00434642|Drug|Bevacizumab|Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL [25 mg/mL]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
12021015|NCT00434642|Drug|Placebo|Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
12021016|NCT00434629|Drug|Bexxar|"Day 0: Tositumomab, IV (in the vein) followed by test dose of 131I-Tositumomab, IV (in the vein) to determine treatment dose of 131I-Tositumomab.
~1-2 weeks after Day 0: Tositumomab, IV (in the vein) followed by therapeutic dose 131I-Tositumomab (in the vein)."
12021017|NCT00434616|Procedure|Autologous bone marrow cell concentrate transplantation|bone marrow aspiration (240 ml), processing and reinjection
12021018|NCT00434616|Biological|saline injection|saline injections
12021019|NCT00434603|Behavioral|Expressive Arts--Theatre Skills Training Program|The experimental intervention was an intensive theatre skills training program. The group of adolescent participants recovering from ABI met daily for four hours over a period of 4 weeks. During this 4 hour period, regular breaks were scheduled to provide the participants with a mental and physical break from therapy. Theatre training included voice work, breathing, movement, physical warm-up, character development, script analysis, writing skills, three-dimensional awareness, group dynamics, story development, mask work and clowning among others.
12021020|NCT00434590|Drug|Enteric coated mycophenolate sodium (Myfortic®)|
12021021|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A Low Dose|Single or two-dose intramuscular injection.
12021022|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A Medium Dose|Single or two-dose intramuscular injection.
12021023|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A High Dose|Single or two-dose intramuscular injection.
12021024|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A Modified|Single or two-dose intramuscular injection.
12021025|NCT00434577|Biological|Placebo|Single intramuscular injection
12021026|NCT00434564|Procedure|Stress nuclear scan|
12021027|NCT00434538|Device|BST-DermOn|
12021028|NCT00434525|Procedure|Laparoscopic restrictive procedure|Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
12021029|NCT00434525|Procedure|Sleeve gastrectomy|Sleeve gastrectomy
12021030|NCT00434512|Biological|HIV vaccine 732461|
12021031|NCT00434499|Drug|EGCG|EGCG 400 mg by mouth twice/daily for 4 weeks duration.
12021032|NCT00434486|Drug|SKI-606|
12021033|NCT00434473|Drug|A-001|A-001
12021034|NCT00434473|Other|Placebo|Placebo
12021035|NCT00434460|Behavioral|Education|Implementation of clinical practice guideline for ventilator associated pneumonia through education.
12021036|NCT00434447|Drug|Zoledronic acid|
12021037|NCT00434434|Drug|omalizumab|Aged Liquid; subcutaneous repeating dose
12021038|NCT00434434|Drug|omalizumab|Lyophilized; subcutaneous repeating dose
12021039|NCT00434434|Drug|placebo|Subcutaneous repeating dose
12021040|NCT00434421|Drug|Glycerinated German cockroach allergenic extract|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
12021041|NCT00434421|Drug|Placebo|Placebo was administered only as the first dose (e.g., representing no Glycerinated German Cockroach bioequivalent allergy units) during the initial 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. Refer to the Glycerinated German cockroach allergenic extract treatment for more details. Route of administration: sublingual-oral route.
12021042|NCT00434408|Behavioral|chx once|4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth
12021043|NCT00434408|Behavioral|CHX x 7 days|4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
12021044|NCT00434408|Behavioral|dry cord care|Household members are instructed to apply nothing to the newborn's umbilical cord stump.
12021045|NCT00434395|Drug|MOA-728|
12021046|NCT00434382|Drug|Sevoflurane|
12021047|NCT00434382|Drug|Isoflurane|
12021048|NCT00434382|Drug|Desflurane|
12021049|NCT00434382|Drug|Propofol|
12021050|NCT00434382|Drug|Fentanyl|
12021051|NCT00434382|Drug|Sufentanil|
12021052|NCT00434382|Drug|Alfentanil|
12021053|NCT00434382|Drug|Remifentanil|
12021054|NCT00434382|Device|Midlatency auditory evoked potentials|
12021055|NCT00434369|Drug|CoFactor (ANX-510)|
12021056|NCT00434356|Drug|bevacizumab|Intravenous repeating dose
12021057|NCT00434356|Drug|sunitinib|Oral repeating dose
12021058|NCT00434356|Drug|paclitaxel|Intravenous repeating dose
12021059|NCT00434343|Procedure|Physical Therapy|
12021060|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
12021061|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
12021151|NCT00433654|Other|Magnetic Resonance Imaging (MRI) scan|One hour MRI scan on the head and lower back.
12021152|NCT00433641|Drug|sibutramine|placebo
12021062|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
12021063|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
12021064|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
12021065|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
12021066|NCT00434317|Drug|Zoledronic acid|
12021067|NCT00434304|Drug|Ropinirole prolonged release/extended release(PR/XR)|Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).
12021068|NCT00434291|Drug|TG-873870(Nemonoxacin)|
12021069|NCT00434278|Drug|Dornase alfa|2.5 mg inhalation dose twice daily for 14±2 days
12021070|NCT00434278|Drug|placebo|2.5 mg inhalation dose twice daily for 14±2 days
12021071|NCT00434265|Behavioral|Physical training|
12021072|NCT00434252|Drug|bevacizumab|15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study)
12021073|NCT00434252|Drug|carboplatin|Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 3-week cycle, for a maximum of 10 cycles
12021074|NCT00434252|Drug|paclitaxel|175 mg/m^2 by IV infusion on the first day of each 3-week cycle (dose was based on patient's weight and could be adjusted for weight change)
12021075|NCT00434252|Drug|placebo|Administered by IV infusion on the first day of each 3-week cycle
12021076|NCT00434239|Drug|Lenalidomide + Ancestim|Dose level 1. Lenalidomide 10mg orally daily days 1-21/ 28 day cycle Ancestim 10mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle. Dose level 2 Ancestim 20mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle
12021077|NCT00434226|Drug|bevacizumab|Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
12021078|NCT00434226|Drug|sunitinib|25 mg/day for 2 weeks, followed by 1 week of rest
12021079|NCT00434226|Drug|carboplatin|On the first day of each cycle for 4 cycles
12021080|NCT00434226|Drug|paclitaxel|On the first day of each cycle for 4 cycles
12021081|NCT00434213|Drug|Daytrana|Methylphenidate Transdermal System (MTS)
12021082|NCT00434200|Procedure|long-term intensive exercise|
12021083|NCT00434187|Drug|ERB-041|
12021084|NCT00434174|Drug|Everolimus|"RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths.
~Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed."
12021085|NCT00434174|Drug|Pemetrexed|Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline
12021086|NCT00434161|Drug|Palifermin before only|One bolus IV injection at 60 μg/kg/day, on Days 6, 5 & 4 days before-high dose chemotherapy and one bolus IV injection at 60 μg/kg/day of matched placebo on days 0, 1 & 2 days after-high dose chemotherapy. Minimum of 4 days between before-chemotherapy and after-transplantation dosing.
12021087|NCT00434161|Drug|Placebo|"One bolus IV injection at 60 μg/kg/day of matched placebo on Days 6, 5 & 4 (before-high dose chemotherapy) and on Days 0, 1 & 2 (after-high dose chemotherapy).
~Minimum of 4 days between pre-chemotherapy and post-transplantation dosing."
12021088|NCT00434161|Drug|Palifermin before and after|"One bolus IV injection at 60 μg/kg/day, on Days 6, 5 & 4 (before-high dose chemotherapy) and on Days 0, 1 & 2 (after-high dose chemotherapy).
~Minimum of 4 days between before-chemotherapy and after-transplantation dosing."
12021089|NCT00434148|Drug|Pasireotide|
12021090|NCT00434135|Drug|gemcitabine plus pemetrexed, paclitaxel plus gemcitabine|gemcitabine 1,250 mg/sqm days 1&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1&8
12021091|NCT00434122|Drug|Degarelix mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
12021092|NCT00434122|Drug|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
12021153|NCT00433641|Drug|sibutramine|oral 15 mg sibutramine once per day
12021154|NCT00433641|Drug|sibutramine|oral sibutramine 10 mg once per day
12021155|NCT00433615|Drug|R744|100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks
12021616|NCT00430365|Drug|placebo|oral placebo
12021093|NCT00434109|Drug|Sunitinib malate|Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks. No fewer than seven days shall separate treatment with Sutent and scheduling of hepatic artery embolizations.
12021094|NCT00434109|Procedure|Hepatic Artery Embolizations|1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor.
12021095|NCT00434096|Drug|rimonabant (SR141716)|oral administration once daily
12021096|NCT00434096|Drug|placebo|oral administration once daily
12021097|NCT00434083|Drug|sumatriptan|
12021098|NCT00434083|Drug|naproxen sodium|
12021099|NCT00434057|Device|MelaFind(R)|Biopsy ratio comparison
12021100|NCT00434044|Drug|Enbrel (etanercept)|
12021101|NCT00434031|Drug|docetaxel|
12021102|NCT00434031|Drug|cyclophosphamide|
12021103|NCT00434031|Drug|trastuzumab|
12021104|NCT00434031|Drug|liposomal doxorubicin|
12021105|NCT00434018|Behavioral|Wheelchair Skills Training|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
12021106|NCT00434018|Behavioral|Basic Health Education|Five sessions are held with subjects to provide them with educational information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc.
12021107|NCT00434005|Drug|N-acetylcysteine, ascorbate|NAC: 600mg twice daily for the day prior to exposure and 1x pre-exposure Ascorbate: 500mg twice daily for 7 days prior to exposure
12021108|NCT00434005|Drug|Placebo|matched appearance to acetylcysteine and ascorbate intervention
12021109|NCT00433979|Drug|antiretroviral treatment|These antiretroviral drugs are a part of the participant's current drug regimen.
12021110|NCT00433966|Drug|Bivalirudin|Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
12021111|NCT00433966|Drug|Unfractionated heparin|60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
12021112|NCT00433966|Device|Bare metal stent|Uncoated bare metal stent
12021113|NCT00433966|Device|Paclitaxel-eluting stent|slow rate-release paclitaxel-eluting stent
12021114|NCT00433953|Drug|Mycophenolate Mofetil (CellCept)|
12021115|NCT00433953|Behavioral|Dietary Monitoring|
12021116|NCT00433953|Behavioral|Drug Diary|
12021117|NCT00433953|Procedure|Blood Sampling|
12021118|NCT00433940|Drug|Prednisolone|Oral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg.
12021119|NCT00433927|Drug|5-FU|5-FU 400 mg/m² Bolus day 1 5-FU 2400 mg/m² iv over 46 h day 1-2
12021120|NCT00433927|Drug|folinic acid|Folinsäure (racemisch) 400 mg/m² iv, 120 min d 1
12021121|NCT00433927|Drug|irinotecan|Irinotecan 180 mg/m² iv, 30 - 90 min day 1
12021122|NCT00433927|Drug|cetuximab|Cetuximab initial 400mg/m² as 120 min infusion, than 250 mg/m² iv as 60 min infusion d 1 + 8
12021123|NCT00433927|Drug|bevacizumab|Bevacizumab 5 mg/kg iv over 30 to 90 minutes d 1
12021124|NCT00433914|Biological|rMenB|One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
12021125|NCT00433914|Biological|rMenB+OMV|One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
12021126|NCT00433901|Behavioral|Targeted parental instruction for positive lifestyle change with follow-up calls.|
12021127|NCT00433888|Drug|R744|100μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
12021128|NCT00433888|Drug|R744|150μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
12021129|NCT00433875|Drug|AMG 714|
12021130|NCT00433849|Drug|R744|100μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks
12021131|NCT00433849|Drug|R744|150μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks
12021132|NCT00433836|Drug|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
12021133|NCT00433836|Drug|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
12021134|NCT00433823|Drug|Atorvastatin, Ezetimibe|
12021135|NCT00433797|Dietary Supplement|Prostate cancer, phytochemical and PUFA|Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
12021136|NCT00433784|Drug|Clopidogrel|
12021137|NCT00433784|Procedure|Blood sampling - platelet aggregation|
12021138|NCT00433784|Procedure|Blood sampling - genotyping|
12021139|NCT00433771|Device|WallFlex™ Biliary Fully Covered Metal Stent placement|Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.
12021140|NCT00433758|Device|GlucoTrack|GT
12021141|NCT00433745|Drug|WT1 Peptide Vaccine|WT1 vaccination (9 doses of WT-1:126-134 peptide (in Montanide adjuvant) administered concomitantly with GM-CSF (Sargramostim)
12021142|NCT00433732|Drug|sumatriptan|
12021143|NCT00433732|Drug|naproxen sodium|
12021144|NCT00433719|Drug|Combivir and efavirenz|Arm 1: Combivir and efavirenz for 12 months Arm 2: Placebo for 2 months then Combivir and efavirenz for 10 months
12021145|NCT00433706|Procedure|Control position by 3DOBI before the fraction|
12021146|NCT00433706|Procedure|Standard imaging|
12021147|NCT00433693|Drug|R744|50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25~300μg(i.v.)/4 week
12021148|NCT00433680|Behavioral|Healthy Weight|4 weekly 1 hour meetings that encourage reductions in fat and sugar intake and increases in physical activity to decrease onset of obesity and body dissatisfaction.
12021149|NCT00433667|Drug|RWJ-333369|
12021150|NCT00433654|Device|Implantable Pulse Generator (IPG) and Pacing Leads (wires)|Pacer and leads
12021341|NCT00432510|Drug|C1 esterase inhibitor [human] (C1INH-nf)|
12021156|NCT00433615|Drug|R744|150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks
12021157|NCT00433602|Other|clinical observation|
12021158|NCT00433602|Procedure|management of therapy complications|
12021159|NCT00433602|Procedure|ultrasound imaging|
12021160|NCT00433589|Drug|anthracycline-based|
12021161|NCT00433589|Drug|docetaxel and capecitabine|
12021162|NCT00433576|Drug|resveratrol|Given orally
12021163|NCT00433576|Other|pharmacological study|Correlative studies
12021164|NCT00433576|Other|laboratory biomarker analysis|Correlative studies
12021165|NCT00433563|Radiation|Once daily radiotherapy|Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy
12021166|NCT00433563|Radiation|Twice daily radiotherapy|Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy
12021167|NCT00433550|Drug|capecitabine|given orally
12021168|NCT00433550|Drug|irinotecan hydrochloride|given IV
12021169|NCT00433550|Drug|oxaliplatin|given IV
12021170|NCT00433537|Drug|bortezomib|Given IV
12021171|NCT00433537|Biological|rituximab|Given IV
12021172|NCT00433537|Drug|cyclophosphamide|Given IV
12021173|NCT00433537|Drug|doxorubicin hydrochloride|Given IV
12021174|NCT00433537|Drug|vincristine|Given IV
12021175|NCT00433537|Drug|dexamethasone|Given IV
12021176|NCT00433537|Biological|filgrastim|Given SC
12021177|NCT00433537|Biological|pegfilgrastim|Given SC
12021178|NCT00433537|Procedure|Autologous stem cell transplantation (ASCT)|
12021179|NCT00433524|Procedure|computed tomography|
12021180|NCT00433511|Biological|Bevacizumab|Given IV
12021181|NCT00433511|Drug|Cyclophosphamide|Given IV
12021182|NCT00433511|Drug|Doxorubicin Hydrochloride|Given IV
12021183|NCT00433511|Other|Laboratory Biomarker Analysis|Correlative studies
12021184|NCT00433511|Drug|Paclitaxel|Given IV
12021185|NCT00433511|Other|Placebo Administration|Given IV
12021186|NCT00433511|Other|Quality-of-Life Assessment|Ancillary studies (closed as of 5/28/10)
12021187|NCT00433498|Drug|carboplatin|Should be given according to local practice but suggested doses and schedules are provided in the protocol.
12021188|NCT00433498|Drug|cisplatin|Should be given according to local practice but suggested doses and schedules are provided in the protocol.
12021189|NCT00433498|Drug|etoposide phosphate|Day 1: given by IV, days 2 and 3 given by IV or oral. Dose should be given according to local practice but suggested doses and schedules are provided in the protocol.
12021190|NCT00433498|Drug|pravastatin sodium|40mg daily oral tablet taken for a maximum of 2 years
12021191|NCT00433485|Drug|sirolimus|
12021192|NCT00433485|Genetic|comparative genomic hybridization|
12021193|NCT00433485|Genetic|gene expression analysis|
12021194|NCT00433485|Genetic|microarray analysis|
12021195|NCT00433485|Genetic|protein expression analysis|
12021196|NCT00433485|Genetic|proteomic profiling|
12021197|NCT00433485|Other|laboratory biomarker analysis|
12021198|NCT00433485|Other|mass spectrometry|
12021199|NCT00433485|Procedure|biopsy|
12021200|NCT00433472|Device|magnetic resonance imaging (MRI)|MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI
12021201|NCT00433459|Drug|cyclophosphamide|drug is used in first line treatment in combination (COPP or COPDAC)
12021202|NCT00433459|Drug|dacarbazine|drug is used in first line treatment in combination (COPDAC)
12021203|NCT00433459|Drug|prednisolone|drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
12021204|NCT00433459|Drug|prednisone|drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
12021205|NCT00433459|Drug|procarbazine hydrochloride|drug is used in first line treatment in combination (COPP)
12021206|NCT00433459|Drug|vincristine sulfate|drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
12021207|NCT00433459|Radiation|fludeoxyglucose F 18|used as a diagnostic marker for metabolically active tumour at staging and response assessment
12021208|NCT00433459|Radiation|radiation therapy|part of combination treatment (combined modality between chemo- and radiotherapy)
12021209|NCT00433446|Biological|CNTO 328|
12021210|NCT00433433|Drug|ABVD q4 weeks|Doxorubicin 25 mg/m2 i.v. day 1 and 15; Bleomycin 10 mg/m2 i.v./i.m. day 1 and 15; Vinblastine 6 mg/m2 i.v. day 1 and 15; Dacarbazine 375 mg/m2 i.v. day 1 and 15
12021211|NCT00433433|Drug|BEACOPP escalated q3 weeks|Cyclophosphamide 1250 mg/m2 i.v. day 1; Doxorubicin 35 mg/m2 i.v. day 1; Vincristine 1.4 mg/m2 i.v.(max.2mg) day 8; Bleomycin 10 mg/m2 i.v./i.m. day 8; Etoposide 200 mg/m2/ i.v. day 1 to 3; Procarbazine 100 mg/m2 orally day 1 to 7; Prednisone 40 mg/m2 orally day 1 to 14; G-CSF 5 mcg/kg s.c. day 9 to recovery leukocytes>1.0x109/l
12021212|NCT00433433|Radiation|IN-RT 30 Gy (+ boost 6 Gy residual)|
12021213|NCT00433433|Procedure|FDG-PET scan|
12021214|NCT00433420|Biological|pegfilgrastim|
12021215|NCT00433420|Drug|cyclophosphamide|
12021216|NCT00433420|Drug|epirubicin hydrochloride|
12021217|NCT00433420|Drug|fluorouracil|
12021218|NCT00433420|Drug|paclitaxel|
12021219|NCT00433420|Procedure|adjuvant therapy|
12021220|NCT00433407|Biological|trastuzumab|
12021221|NCT00433394|Procedure|cancer prevention intervention|
12021222|NCT00433394|Procedure|educational intervention|
12021223|NCT00433381|Biological|Bevacizumab|Given IV
12021224|NCT00433381|Drug|Irinotecan Hydrochloride|Given IV
12021225|NCT00433381|Drug|Temozolomide|Given orally
12021226|NCT00433368|Drug|L-Ornithine L-Aspartate|
12021227|NCT00433342|Drug|Flucloxacillin|500 mg QD oral
12021228|NCT00433329|Drug|Bosentan|Oral bosentan 62.5 mg BID first 4 weeks followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated
12021229|NCT00433329|Drug|Sildenafil|Oral sildenafil 20 mg TID in patients who do not reach the 6-MWT distance threshold at Week 16
12021230|NCT00433316|Drug|ropivacaine|1% ropivacaine
12021231|NCT00433316|Device|Aeroneb Pro Nezulizer, Aerogen, Ireland|Aeroneb Pro Nezulizer, Aerogen, Ireland
12021232|NCT00433303|Behavioral|Correlation between early delivery and coital activity|
12021233|NCT00433290|Drug|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
12021234|NCT00433290|Drug|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
12021235|NCT00433277|Drug|twice-daily dosage with 0.5% cyclosporine-A eyedrops|
12021236|NCT00433264|Procedure|peritoneal dialysis|individualised
12021237|NCT00433238|Behavioral|Participants will be screened for depression and cognitive impairment, then receive screening results.|
12021238|NCT00433225|Drug|Prednisolone Acetate|
12021239|NCT00433225|Drug|Ketorolac 0.4%|
12021240|NCT00433225|Drug|Gatifloxacin 0.3%|
12021241|NCT00433212|Device|nCPAP|Deliver non-invasive respiratory support via ventilator with nCPAP device
12021242|NCT00433212|Device|NIPPV|Deliver non-invasive respiratory support via ventilator with NIPPV device
12021243|NCT00433199|Drug|Testosterone (T) Gel 1.62%|Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
12021244|NCT00433199|Drug|Placebo|Placebo Control
12021245|NCT00433186|Drug|Mycophenolate Mofetil|Mycophenolate 3000 mg each day
12021246|NCT00433173|Procedure|intravenous glucose tolerance test|The IVGTT (70) is a 4 hour study with baseline sampling for insulin and glucose, followed by the administration of 0.3 mg/kg infusion of glucose, and subsequent frequent samples through 180 minutes. At 20 minutes, subjects will receive a 0.03 U/kg infusion of regular human insulin over 45 seconds to enhance the insulin level to better help us assess the impact of insulin on glucose uptake and to facilitate minimal model analysis. The IVGTT will be administered at baseline and after 3 months.
12021247|NCT00433173|Drug|testosterone|transdermal 7.5 g/per day for 3 months
12021248|NCT00433173|Drug|anastrozole|tablet (per oral) 10.0 mg/ daily 3 months
12021249|NCT00433173|Drug|goserelin acetate implant|single depot injection 10.8 mg 3 months
12021250|NCT00433173|Procedure|aerobic capacity (VO2 Max)|This test is employed to assess VO2max in all subjects. O2 and CO2 will be collected and measured from the expired air during the exercise stress test and used to calculate VO2max. This test will be administered at baseline and after 3 months.
12021251|NCT00433173|Procedure|MRI|1H-MR spectroscopy will be performed to measure IMCL at baseline and after 3 months.
12021252|NCT00433173|Procedure|muscle biopsy|Biopsies (20-50mg) will be obtained from the vastus lateralis muscle under local anesthesia (1% lidocaine) using a 5 mm Bergström needle (65) with suction applied. The muscle biopsy will be performed at baseline and after 3 months.
12021253|NCT00433173|Procedure|measurement of resting metabolic rate (energy expenditure)|Energy expenditure in the form of resting metabolic rate (RMR) will be measured via a metabolic monitor at baseline and after 3 months.
12021254|NCT00433173|Procedure|Dual energy x-ray absorptiometry|Total and regional percent body fat, fat mass, lean tissue mass and bone mineral content will be determined by DEXA (Lunar Prodigy version 8.50). DEXA provides an in vivo assessment of body composition with minimal requirements for subject cooperation and will be employed at baseline and after 3 months.
12021255|NCT00433173|Procedure|Fasting oral glucose tolerance test|To examine glucose and insulin metabolism a standard 75g OGTT will be conducted at baseline and after 3 months.
12021256|NCT00433160|Drug|Teriparatide|daily, subcutaneous
12021257|NCT00433160|Drug|Placebo|daily, subcutaneous
12021258|NCT00433147|Drug|Afegostat tartrate|
12021259|NCT00433134|Behavioral|Adherence|
12021260|NCT00433121|Drug|Risperidone|
12021261|NCT00433121|Drug|Olanzapine|
12021262|NCT00433121|Drug|Haloperidole|
12021263|NCT00433121|Drug|Quetiapin|
12021264|NCT00433121|Drug|Escitalopram|
12021265|NCT00433121|Drug|Citalopram|
12021266|NCT00433121|Drug|Sertralin|
12021267|NCT00433108|Drug|Mitoquinone mesylate (MitoQ)|
12021268|NCT00433095|Drug|Navelbine|
12021269|NCT00433095|Drug|Herceptin|
12021270|NCT00433095|Drug|Navelbine (oraly)|
12021271|NCT00433082|Behavioral|Ramadan Fasting|
12021272|NCT00433069|Drug|Pioglitazone|Increase early virological response to pegylated interferon alpha plus ribavirin by increasing insulin sensitivity
12021273|NCT00433069|Drug|Interferon Alfa-2a|Standard of care for chronic hepatitis C
12021274|NCT00433069|Drug|Ribavirin|Standard of care for chronic hepatitis C
12021275|NCT00433056|Other|STI|CD4 guided treatment interruption
12021276|NCT00433056|Drug|stable HAART|continuous therapy
12021277|NCT00433043|Drug|Beta blocker (carvedilol or metoprolol succinate)|Both groups get CRT. Group 1 is uptitrated to target dose beta blocker after CRT. Group 2 maintains their b-blocker dose from study entry.
12021278|NCT00433043|Procedure|CRT (cardiac resynchronization therapy)|Both arms
12021279|NCT00433017|Drug|Verteporfin Photodynamic Therapy|After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of the infusion.
12021280|NCT00433017|Drug|Ranibizumab|Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection
12021281|NCT00433017|Drug|Placebo|As a placebo for verteporfin photodynamic therapy (for masking purposes), patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.
12021282|NCT00433004|Drug|Plan B (Levonorgestrel)|PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.
12021283|NCT00432991|Drug|Ephedrine [Synonyms: Ephedra, Ephedrinum]|25 mg, IM (in the muscle), one time
12021284|NCT00432991|Drug|Saline Placebo|0.5 mL, IM (in the muscle), one time
12021285|NCT00432978|Drug|Bosentan administration|
12021286|NCT00432965|Device|Moist Wound Therapy|Moist Wound Therapy (Standard of Care)
12021287|NCT00432965|Device|VAC Therapy|VAC Therapy
12021288|NCT00432952|Behavioral|Intake of rainbow trout from different feeding conditions versus a control poultry meal|
12021390|NCT00432120|Drug|clopidogrel|To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention
12021289|NCT00432926|Behavioral|EDGE counseling, no maintenance|Five-session behavior change intervention that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports).
12021290|NCT00432926|Behavioral|EDGE counseling, plus maintenance|Five-session behavior change intervention (identical to Arm 1) that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports) PLUS eight group-format safer sex maintenance counseling sessions, which utilize clinical strategies from relapse prevention to identify high risk situations and develop effective coping strategies.
12021291|NCT00432926|Behavioral|Attention control|An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.
12021292|NCT00432913|Drug|Eicosapentaenoic Acid (EPA)|Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)
12021293|NCT00432913|Procedure|Endoscopy|At baseline, month 3 and month 6.
12021294|NCT00432913|Procedure|Biopsies taken|9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.
12021295|NCT00432913|Procedure|Clinical chemistry|Full blood count at baseline, month 3 and month 6.
12021296|NCT00432913|Procedure|Haematology|Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
12021297|NCT00432913|Procedure|Physical examination|Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
12021298|NCT00432913|Procedure|Vital signs|Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
12021299|NCT00432913|Procedure|Urine pregnancy test|For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
12021300|NCT00432913|Procedure|Completion of patient diary card|Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.
12021301|NCT00432900|Radiation|[(11)C]PBR28|PET Ligand
12021302|NCT00432887|Drug|caffeine administration|
12021303|NCT00432874|Procedure|wound hydration method|Anterior vs lateral wound hydration
12021304|NCT00432861|Drug|PANCRECARB® (pancrelipase)|Capsules
12021305|NCT00432861|Drug|Placebo|Capsules
12021306|NCT00432835|Device|Gastric Electrical Stimulator, Enterra, Medtronics, Inc.|All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
12021307|NCT00432822|Drug|tetrahydrobiopterin (BH4)|
12021308|NCT00432809|Procedure|Gastric bypass|Roux-en-Y gastric bypass
12021309|NCT00432809|Procedure|Sleeve Gastrectomy|Laparoscopic sleeve gastrectomy
12021310|NCT00432796|Drug|Dalteparin|5,000 iu or 200 iu/kg depending on the type of surgery injection will be given subcutaneously, once a day for a minimum of 4 days or until the INR is 2.0
12021311|NCT00432796|Other|Placebo|"patients will be randomized post-operative to receive either active treatment or placebo.
~the placebo will be given as a subcutaneous injection once a day. the amount of the placebo will be equivalent to the active treatment depending on the type of surgery.
~ie. 5,000 iu or 200 iu/kg"
12021312|NCT00432770|Drug|ARC1779|
12021313|NCT00432757|Drug|Ketotifen with a Contact Lens (generic name not yet established)|
12021314|NCT00432744|Drug|CoenzymeQ10|CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.
12021315|NCT00432744|Drug|Placebo|Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
12021316|NCT00432731|Biological|VARIVAX®|
12021317|NCT00432731|Biological|M-M-RTM II|
12021318|NCT00432718|Procedure|Saline Instillation before Tracheal Suctioning|
12021319|NCT00432705|Procedure|Checking stability of ankle|Flexing and walking
12021320|NCT00432692|Procedure|Falls Prevention Program|
12021321|NCT00432679|Drug|Rosiglitazone (BRL49653C)|study drug
12021322|NCT00432666|Drug|IncobotulinumtoxinA (Xeomin)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection"
12021323|NCT00432666|Drug|Placebo|Placebo
12021324|NCT00432653|Drug|rituximab|
12021325|NCT00432640|Procedure|Endoscopic ultrasound staging|Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA
12021326|NCT00432640|Procedure|Surgical staging|Surgical staging
12021327|NCT00432627|Drug|Deferasirox|one dose of 20 mg/kg/day
12021328|NCT00432614|Drug|SR58611A|oral administration
12021329|NCT00432614|Drug|escitalopram|oral administration
12021330|NCT00432614|Drug|placebo|oral administration
12021331|NCT00432601|Behavioral|type of decision aid|We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.
12021332|NCT00432588|Drug|misoprostol|
12021333|NCT00432588|Drug|dinoprostone|
12021334|NCT00432575|Drug|surinabant (SR147778)|oral administration
12021335|NCT00432575|Drug|placebo|oral administration
12021336|NCT00432562|Drug|Vinorelbine Tartrate|Subjects received one dose each of ANX-530 and NAVELBINE, each providing 30 mg/m2 vinorelbine. Study drugs will be infused into an arm vein over ten minutes.
12021337|NCT00432549|Drug|Almotriptan|
12021338|NCT00432549|Drug|Topiramate|
12021339|NCT00432536|Other|Quality improvement intervention|determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation
12021340|NCT00432523|Biological|M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®|
12021342|NCT00432484|Drug|Lingzhi and Sen Miao San|G lucidum and SMS were supplied as capsules, containing 4.0 gm of G lucidum extract, 2.4 gm of Rhizoma atractylodis (Cangzhu), 2.4 gm of Cotex phellodendri(Huangbai), and 2.4 gm of Radix achyranthes Bidentatae(Niuxi). Each patient took either 3 capsules twice daily as recommended by the TCM experts or identical-looking placebo.
12021343|NCT00432471|Procedure|Optical Imaging|Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.
12021344|NCT00432458|Drug|Thalidomide|200 mg orally on days 1-28 of 28 day cycle
12021345|NCT00432458|Drug|zoledronic acid|4 mg^2 by IV on day 1 every 84 days for 1 year and once per year thereafter
12021346|NCT00432445|Radiation|Proton Beam Radiation Therapy|Radiation given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks.
12021347|NCT00432445|Procedure|Ophthalmic EUA|Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary)
12021348|NCT00432432|Drug|Infliximab and MTX|MTX 15mg weekly Infliximab 5mg/kg given at day 0, wk 2, wk6
12021349|NCT00432419|Procedure|autologous peripheral blood cell transplantation|
12021350|NCT00432406|Drug|Infliximab|Infliximab 5 mg/kg given at day 1, week 2, week 6
12021351|NCT00432406|Drug|Etanercept|Etanercept 25 mg twice weekly
12021352|NCT00432393|Drug|levodopa-carbidopa|
12021353|NCT00432380|Biological|Rotarix™|oral doses
12021354|NCT00432380|Biological|Placebo|oral dose
12021355|NCT00432367|Drug|Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine|"Eligible women will be allocated randomly to one of three groups and treated as follows:
~Arm 1 (OptiMAL® antigen screening and treatment with SP plus LLIN group) - a woman in this will receive 1500mg/75mg (S/P) administered at the ANC as single dose on enrollment if her screening test is positive.
~Arm 2 (OptiMAL® antigen screening and treatment with AQ+AS plus LLIN) - a woman in this will receive 300mg of AQ and 100mg co-administered two times a day for 3 days if her screening test is positive. The first dose is observed on enrolment day at the ANC.
~Arm 3 (SP-IPTp plus LLIN group) - a woman in this will receive 1500mg/75mg (S/P) administered at the ANC as single dose on enrollment as recommended by national policy.
~All enrolled women will be given one long lasting insecticide treated bed net each for use."
12021356|NCT00432354|Drug|atorvastatin|
12021357|NCT00432341|Biological|botulinum toxin type A|200 Units at Visit 1 (Day 1)
12021358|NCT00432341|Biological|botulinum toxin type A|500 Units at Visit 1 (Day 1)
12021359|NCT00432328|Drug|Avotermin|
12021360|NCT00432315|Drug|Docetaxel + CDDP|"3 cycles chemotherapy : docetaxel + CDDP
~Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered)
~3 cycles adjuvant chemotherapy docetaxel"
12021361|NCT00432315|Drug|docetaxel + CDDP|"3 cycles chemotherapy: docetaxel + CDDP
~Radiochemotherapy
~3 cycles adjuvant chemotherapy docetaxel"
12021362|NCT00432302|Drug|Sagopilone (BAY 86-5302, ZK 219477)|First infusion only: 28 mg, containing 14 kBq/7.8 mcg [14C]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min.
12021363|NCT00432289|Procedure|Acupuncture|Acupunture treatment 3x per week for 6 weeks.
12021364|NCT00432276|Drug|Alogliptin|Alogliptin tablets.
12021365|NCT00432276|Drug|Pioglitazone|Pioglitazone tablets.
12021366|NCT00432276|Drug|Metformin|Metformin HCl tablets (immediate-release, commercially available formulation) ≥1500 mg or maximum tolerated dose.
12021367|NCT00432276|Drug|Placebo|Matching placebo tablets.
12021368|NCT00432263|Drug|Genotropin (PN-180,307) Somatropin|
12021369|NCT00432250|Procedure|Cervical length ultrasound|
12021370|NCT00432237|Drug|MK0974 50 mg|
12021371|NCT00432237|Drug|MK0974 150 mg|
12021372|NCT00432237|Drug|MK0974 300 mg|
12021373|NCT00432237|Drug|Comparator: Placebo|MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
12021374|NCT00432224|Procedure|photodynamic therapy|
12021375|NCT00432211|Drug|Avotermin|"Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration.
~Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration."
12021376|NCT00432198|Drug|Zolpidem (Myslee®)|Oral
12021377|NCT00432198|Drug|placebo|Oral
12021378|NCT00432185|Drug|PEP005|0.25% PEP005 Gel
12021379|NCT00432172|Drug|Epirubicin|
12021380|NCT00432172|Drug|Cyclophosphamide|
12021381|NCT00432172|Drug|Docetaxel|
12021382|NCT00432172|Drug|Exemestane|
12021383|NCT00432172|Drug|Goserelin|
12021384|NCT00432172|Drug|Carboplatin|
12021385|NCT00432159|Device|Cervical TDR|Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
12021386|NCT00432159|Device|ACDF with plate|Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
12021387|NCT00432146|Drug|lugol's solution|
12021388|NCT00432133|Behavioral|Protection Motivation Theory-Based Intervention|Targets perceptions of outcome severity and susceptibility, self-efficacy, response efficacy, response costs, and rewards of physical inactivity. One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
12021389|NCT00432133|Behavioral|Environmenta|Targets increased awareness and use of local parks and trials near the home and work environments. Targets increased access by providing membership to a local fitness facility for 12 months. One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
12021391|NCT00432107|Drug|APO866|APO866 is administered as 0.126 mg/m²/hr IV every 4 weeks for 4 consecutive days (96 hours) for a total of 3 cycles
12021392|NCT00432094|Drug|carboplatin|Days -6, -5, -4: 500mg/m2^/day intravenously (IV) over 60 minutes
12021393|NCT00432094|Drug|etoposide|600mg/m^2/day intravenously (IV) over 60 minutes on Days -6 through -3.
12021394|NCT00432094|Drug|ifosfamide|2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.
12021395|NCT00432094|Drug|paclitaxel|225 mg/m^2 intravenous over 3 hours on Day -7.
12021396|NCT00432094|Drug|thiotepa|150mg/m^2/day intravenously IV over 30 minutes; Days -6, -5 and -4
12021397|NCT00432094|Procedure|autologous hematopoietic stem cell transplantation|Peripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg)
12021398|NCT00432094|Drug|Mesna|2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.
12021399|NCT00432094|Biological|filgrastim|Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
12021400|NCT00432081|Drug|indomethacin|
12021401|NCT00432068|Drug|Octreotide pamoate|
12021402|NCT00432055|Drug|Botulinum toxin type A (Botox)|
12021403|NCT00432055|Drug|placebo (saline)|
12021404|NCT00432042|Biological|ProQuad®|Participants received a 0.5 mL subcutaneous injection of ProQuad® containing the following live attenuated virus strains: measles virus Enders' Edmonston strain (≥3.00 log10 50% cell culture infectious dose [CCID]50), mumps virus Jeryl Lynn™ (Level B) strain (≥4.30 log10 CCID50), rubella virus Wistar RA 27/3 strain (≥3.00 log10 CCID50), and varicella virus Oka/Merck strain (≥3.99 log10 plaque-forming units [PFU]).
12021405|NCT00432042|Biological|Infanrix® hexa|Participants received a 0.5 mL intramuscular injection of Infanrix® hexa containing the following: diphtheria toxoid (≥30 IU), tetanus toxoid (≥40 IU), 3-component acellular pertussis (pertussis taxoid, filamentous haemagglutinin, and pertactin) (25 ug), Hepatitis B surface antigen recombinant (S protein) (10 ug), inactivated poliovirus types 1-3 (type 1: 40 D-antigen units; type 2: 8 D-antigen units; type 3: 32 D-antigen units), and Haemophilus influenzae type B (Hib) polysaccharide conjugate to tetanus toxoid (20-40 ug).
12021406|NCT00432029|Procedure|Forearm blood flow measurement, Flow mediated dilation (FMD)|Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin
12021407|NCT00432029|Device|Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light|Stimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin
12021408|NCT00432016|Drug|zidovudine|
12021409|NCT00432016|Drug|amdoxovir|
12021410|NCT00432016|Procedure|pharmacokinetic sampling|
12021411|NCT00431990|Drug|depsipeptide|Cohort 1. Dose escalation, IV, Weeklyx3 in a 4week cycle. Cohort 2A. 12mg/m2, IV, Weeklyx3 in a 4week cycle. Cohort 2B. 12mg/m2, IV, Weeklyx2 in a 3week cycle.
12021412|NCT00431990|Drug|bortezomib|Cohort 1 and 2A. 3.5mg/m2, IV, day 1, 4, 8, 11 in 28 day cycle. Cohort 2B. 3.5mg/m2, IV, day 1, 4, 8, 11 in 21 day cycle
12021413|NCT00431990|Drug|dexamethasone|20mg for 2 days with each dose of bortezomib
12021414|NCT00431977|Procedure|coronary computed tomography angiography|
12021415|NCT00431964|Drug|azithromycin 250 mg tablets|"One (1) tablet three times weekly for patients who weigh 40-79 lbs
~Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
12021416|NCT00431964|Drug|placebo tablets|"One (1) tablet three times weekly for patients who weigh 40-79 lbs
~Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
12021417|NCT00431951|Drug|ST-246|250 mg, 400 mg or 800 mg capsules given once daily for 21 days
12021418|NCT00431951|Drug|Placebo|Capsules to match experimental drug
12021419|NCT00431912|Drug|APO866|APO866 is administered as 0.126 mg/m²/hr for 4 consecutive days (96 hours), every 3 weeks for a total of 3 cycles
12021420|NCT00431899|Behavioral|fish oil supplementation|
12021421|NCT00431886|Procedure|64 multi-detector computed tomography|
12021422|NCT00431873|Drug|MGCD0103|MGCD0103 Administered orally three times per week.
12021423|NCT00431860|Procedure|Coronary computed tomographic angiography|
12021424|NCT00431847|Procedure|Regional Anesthesia|Subject received regional anesthesia to affected limb(s) within 72 hours of traumatic event.
12021425|NCT00431847|Procedure|Standard Pain Management Protocol|Intermittent dosing of analgesics and anxiolytics instituted prior to continuous intravenously dosing which was individually titrated to patient care goals.
12021426|NCT00431834|Device|Cardioblate System Surgical Ablation System|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
12021427|NCT00431834|Procedure|Surgical RF Ablation|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
12021428|NCT00431821|Behavioral|Exercise|Home-based exercise prescriptions with weekly motivational telephone calls.
12021429|NCT00431821|Other|Stroke education|Stroke education program with matched attention phone calls
12021430|NCT00431808|Biological|Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]|3 doses of AMA 1 vaccine
12021431|NCT00431808|Biological|AMA1|50 micrograms of AMA1
12021432|NCT00431795|Drug|Pegylated liposomal doxorubicin (Caelyx)|Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
12021433|NCT00431795|Drug|Epirubicin|Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
12021434|NCT00431782|Drug|ATI-5923|
12021500|NCT00431262|Drug|antabuse (disulfiram)|
12021501|NCT00431249|Drug|Cilostazol|
12021502|NCT00431236|Drug|Oral Casopitant (GW679769)|
12021503|NCT00431236|Drug|IV Casopitant (GW679769)|
12021504|NCT00431236|Drug|IV ondansetron hydrochloride|
12021505|NCT00431236|Drug|Oral dexamethasone|
12021435|NCT00431769|Drug|Bortezomib|Bortezomib will be given intravenously (into a vein) twice weekly, on Days 1, 4, 8 and 11 and then a 10-day (Days 12 to 21) rest period, of each 3-week cycle for up to a total of 8 cycles. The initial bortezomib dose is 1.0 or 1.3 milligram per meter square (mg/m^2) depending on the previous bortezomib-based treatment, up to a maximum dose of 1.3 mg/m^2. Participants will receive bortezomib in combination with or without dexamethasone, in accordance with the standard of care. The median total dose of dexamethasone per cycle ranges from 120 mg (Cycle 7) to 160 mg (Cycles 1 to 6 and 8).
12021436|NCT00431743|Drug|Hydroxyethylstarch 130/0,4|
12021437|NCT00431743|Drug|Lactated Ringer's solution|
12021438|NCT00431730|Procedure|flicker light stimulation|
12021439|NCT00431704|Drug|vinorelbine|25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
12021440|NCT00431704|Drug|carboplatin|AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
12021441|NCT00431704|Drug|trastuzumab|8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression
12021442|NCT00431691|Drug|vitamin and mineral supplement|"dose: 4 tablets daily for two weeks
~vitamin A 7160 IU, vitamin C 113mg, vitamin E 100IU, zinc 17.4mg, copper 0.4mg"
12021443|NCT00431691|Drug|Escherichia coli Endotoxin (LPS)|dose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days
12021444|NCT00431691|Drug|100% O2|breathing for 30 minutes, 2 breathing periods on both study days
12021445|NCT00431691|Drug|nitroglycerin|dose: 0,8 mg sublingual, applied during FMD measurements on both study days
12021446|NCT00431678|Drug|Avelox (Moxifloxacin, BAY12-8039)|Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
12021447|NCT00431678|Drug|Levofloxacin + Ceftriaxone|Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days).
12021448|NCT00431665|Drug|NG-monomethyl-L-Arginine (L-NMMA)|
12021449|NCT00431665|Drug|triglycerides (Intralipid 20%)|
12021450|NCT00431665|Drug|heparin|
12021451|NCT00431665|Drug|somatostatin|
12021452|NCT00431665|Drug|insulin|
12021453|NCT00431665|Drug|glucose|
12021454|NCT00431665|Drug|inulin|
12021455|NCT00431665|Drug|paraamino hippurate (PAH)|
12021456|NCT00431639|Behavioral|Animal Assisted Therapy|Every subject will be exposed to both treatment and comparison conditions.
12021457|NCT00431626|Drug|Dutasteride (Avodart)|
12021458|NCT00431626|Drug|Placebo|Placebo before and after treatment of TURP
12021459|NCT00431613|Drug|Docetaxel|Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
12021460|NCT00431613|Drug|Gemcitabine|Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
12021461|NCT00431613|Drug|Carboplatin|Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
12021462|NCT00431613|Radiation|Chemoradiotherapy|"After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy.
~During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32"
12021463|NCT00431613|Drug|Docetaxel|Docetaxel 75mg/m2 IV on day 1 for 3 cycles
12021464|NCT00431600|Other|100% Oxygen|100% Oxygen- breathing over 30 minutes
12021465|NCT00431574|Procedure|dosing|
12021466|NCT00431561|Drug|AP 12009 10 µM|10 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks
12021467|NCT00431561|Drug|AP 12009 80 µM|80 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks
12021468|NCT00431561|Drug|temozolomide or PCV|temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen
12021469|NCT00431561|Device|Drug delivery system for administration of AP 12009|Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.
12021470|NCT00431561|Procedure|Placement of Drug Delivery System|Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
12021471|NCT00431548|Drug|100% O2|
12021472|NCT00431522|Drug|Valproic acid, sodium salt|
12021473|NCT00431509|Procedure|conventional vs. navigated total knee arthroplasty|
12021474|NCT00431496|Drug|Cinacalcet|Cinacalcet tablets
12021475|NCT00431483|Behavioral|pharmaceutical consulting|to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials
12021476|NCT00431470|Behavioral|Six classroom based character building education lessons|
12021477|NCT00431457|Device|Implantation of an intracranial electrode|Implantation of an intracranial electrode will be followed.
12021478|NCT00431457|Procedure|amygddohyppocampertomy|Resective surgery
12021479|NCT00431444|Drug|Raloxifene|
12021480|NCT00431444|Drug|Zoledronic acid|
12021481|NCT00431444|Drug|Placebo oral pills|
12021482|NCT00431444|Drug|Placebo intravenous (i.v.) infusion|
12021483|NCT00431431|Drug|tibolone|2 years treatment with tibolone (1.25 mg Org OD-14)
12021484|NCT00431431|Drug|raloxifen|2 years treatment with raloxifene (60 mg)
12021485|NCT00431418|Drug|Sildenafil|Sildenafil oral solution
12021486|NCT00431418|Drug|Placebo|Placebo solution
12021487|NCT00431392|Drug|Phenylephrine|
12021488|NCT00431392|Drug|NG-Monomethyl-L-Arginine|
12021489|NCT00431392|Drug|Propanolol|
12021490|NCT00431392|Drug|Atropine|
12021491|NCT00431379|Drug|Tenecteplase|
12021492|NCT00431353|Drug|Ganciclovir|5mg/kg iv bid for 21 days
12021493|NCT00431353|Drug|valganciclovir [Valcyte]|900mg po bid for 21 days
12021494|NCT00431340|Drug|PXD101|
12021495|NCT00431327|Behavioral|Peer coach phone call|
12021496|NCT00431288|Behavioral|diet high in fruits, vegetables, and dairy|
12021497|NCT00431288|Behavioral|Routine nutrition care|
12021498|NCT00431275|Drug|CP-675,206|CP-675,206 15 mg/kg iv single dose on Day 1
12021499|NCT00431275|Drug|CP-675,206|CP-675,206 15 mg/kg iv single dose on Day 1
12021506|NCT00431223|Behavioral|Cognitive remediation therapy|36 sessions of computerized cognitive skills training over a 12 week duration. 7 patients were assigned to cognitive remediation therapy or CRT Group.
12021507|NCT00431210|Biological|Epstein-Barr virus-specific adoptive T-cells immunotherapy|Given intravenously on Day 1 and Day 14
12021508|NCT00431197|Drug|Ketoconazole, Dexamethesone, Androgel,GnRH|
12021509|NCT00431184|Drug|Pentazocine|see arms description
12021510|NCT00431184|Drug|Lorazepam|see arms description
12021511|NCT00431171|Drug|Lithium carbonate|
12021512|NCT00431158|Other|Different Mechanical Ventilation Protocols|"OLA Group: Open lung approach protocol and recruitment maneuvers
~ARDSnet Group: ARDSnet protocol"
12021513|NCT00431145|Drug|Niacin|
12021514|NCT00431145|Drug|Niacin+Statin|
12021515|NCT00431132|Drug|estradiol, 10 mcg|Tablets, administered intravaginally twice weekly
12021516|NCT00431119|Drug|Azathioprine or Mycophenolate mofetil|
12021517|NCT00431106|Drug|Gemcitabine|Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
12021518|NCT00431106|Drug|Capecitabine|Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
12021519|NCT00431106|Drug|Vinorelbine|Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles
12021520|NCT00431093|Drug|tibolone|uncoded tablets, at a dose of 2.5 mg per tablet; Subjects were to take 1 Livialâ tablet and 1 -matched Activelleâ placebo tablet, orally, once a day (preferably at the same time).
12021521|NCT00431093|Drug|low-dose estradiol/noresterone|"Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets.
~Subjects were to take 1 Activelleâ tablet and 1 Livialâ-matched placebo tablet, orally, once a day (preferably at the same time)."
12021522|NCT00431080|Drug|Docetaxel|Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
12021523|NCT00431080|Drug|Paclitaxel|Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles
12021524|NCT00431080|Drug|Epirubicin|Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
12021525|NCT00431080|Drug|Cyclophosphamide|Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
12021526|NCT00431080|Drug|5-fluoruracil|5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
12021527|NCT00431080|Drug|Granulocyte-colony stimulating growth factor|rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
12021528|NCT00431067|Drug|BIBW 2992|
12021529|NCT00431054|Drug|Perifosine|Loading Dose = 100 mg by mouth (PO) every 6 hours, followed by 50 mg by mouth (PO) daily
12021530|NCT00431054|Drug|Docetaxel|75 mg/m^2 by vein over 1 hour every 4 weeks
12021531|NCT00431041|Drug|solifenacin|Oral
12021532|NCT00431041|Drug|oxybutynin immediate release|Oral
12021533|NCT00431028|Device|slow delivery ciprofloxacin + triamcinolone|2 mg ciprofloxacin + 25mg triamcinolone
12021534|NCT00431015|Drug|IPI-504|IV Hsp90 inhibitor
12021535|NCT00431002|Behavioral|Resistance training|See Detailed Description.
12021536|NCT00430989|Other|Nitrous Oxide|General anaesthesia with the inclusion of Nitrous Oxide at 70%
12021537|NCT00430989|Other|No Nitrous Oxide|General anaesthesia with no use of Nitrous Oxide
12021538|NCT00430976|Behavioral|Minds in Motion|
12021539|NCT00430963|Drug|IncobotulinumtoxinA (Xeomin) (20 Units)|
12021540|NCT00430963|Drug|Placebo|
12021541|NCT00430950|Drug|olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets|olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
12021542|NCT00430950|Drug|olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
12021543|NCT00430937|Drug|Daptomycin|4 mg/kg intravenous once daily
12021544|NCT00430937|Drug|Vancomycin|1 g intravenous twice daily
12021545|NCT00430937|Drug|Teicoplanin|400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.
12021546|NCT00430924|Drug|Eplerenone|Once daily administration for 8 weeks and 8 weeks control.
12021547|NCT00430911|Drug|Radiotherapy|
12021548|NCT00430898|Drug|Basiliximab|3 doses of 40mg, IV at baseline, week 2, and week 4
12021549|NCT00430885|Drug|Octagam (IVIG)|Intravenous immunoglobulin 0.4 g/kg given as infusion
12021550|NCT00430872|Behavioral|Survey|Survey about the severity of certain symptoms lasting 10-15 minutes.
12021551|NCT00430859|Drug|Alkaline Phosphatase|Intravenous over a period of 24 hours
12021552|NCT00430859|Drug|Placebo|Saline over a period of 24h
12021553|NCT00430846|Drug|SGN-35|Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
12021554|NCT00430833|Drug|candesartan|
12021555|NCT00430820|Procedure|per intervention|per intervention
12021556|NCT00430807|Drug|hydroxychloroquine/placebo|
12021557|NCT00430794|Drug|Spironolactone|
12021558|NCT00430781|Drug|pazopanib (GW786034)|
12021559|NCT00430781|Drug|lapatinib (GW572016)|
12021560|NCT00430768|Biological|rAAV1-CB-hAAT|
12021561|NCT00430755|Device|Computer-assisted history|"Methods The intervention was use of an expert system to acquire medical histories by direct interview of patients.
~Description of the software program - The program tested in this study consisted of a data acquisition [history-taking] component and a data analysis component. The data acquisition component was constructed on the basis of established principles of pathophysiology. Medical knowledge was formalized as software algorithms that were machine-readable by representing the knowledge as branched chain decision trees."
12021562|NCT00430755|Procedure|physician taken history|Convential history taking by physicians
12021563|NCT00430755|Other|Computer-assisted history taking|
12021564|NCT00430742|Drug|Taranabant|Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
12021565|NCT00430742|Drug|Comparator: Placebo|Placebo capsule once daily. Treatment for 52 weeks.
12021566|NCT00430729|Drug|Roflumilast|
12021567|NCT00430716|Drug|Sildenafil citrate|oral, 20 mg, tid
12021568|NCT00430716|Drug|Sildenafil citrate|oral 1 mg, tid
12021569|NCT00430716|Drug|Sildenafil citrate|oral 5 mg, tid
12021571|NCT00430703|Behavioral|body weight support treadmill training|Gait training: Gait robot (Lokomat®, Hocoma, Switzerland) is adjusted to the patient/healthy volunteer individually with chest strap, pelvic straps, harness, leg cuffs and foot lifters. Weight is adjusted individually, so there is a minimum weight support (i.e. when one foot is standing on the treadmill the other foot lifts free from the treadmill thereby simulating normal gait). Gait speed is 1,7-2,3 km/hour (speed can be changed and adjusted that the normal step length is achieved).The duration of the training session is 20 minutes.Blood pressure and pulse are monitored.
12021572|NCT00430690|Procedure|acoustic startle testing|acoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes
12021573|NCT00430677|Drug|Corticosteroids (prednisone or prednisolone)|tablets, oral, 0.5-0.8 mg/kg, daily
12021574|NCT00430677|Drug|Abatacept|intravenous solution, injectable, 30 mg/kg, every 28 days
12021575|NCT00430677|Drug|Abatacept|intravenous solution, injectable, 10 mg/kg, every 28 days
12021576|NCT00430677|Drug|Mycophenolate mofetil (MMF)|tablets, oral, 1.5 to 2 g, daily
12021577|NCT00430677|Drug|Abatacept|intravenous solution, injectable, 10 mg/kg, every 28 days
12021578|NCT00430664|Procedure|Pleurodesis with either talc or iodopovidone|
12021579|NCT00430651|Drug|Docetaxel|Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
12021580|NCT00430651|Drug|Carboplatin|Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15
12021581|NCT00430638|Drug|olmesartan medoxomil + hydrochlorothiazide, if necessary|olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
12021582|NCT00430638|Drug|Placebo|Oral tablets administered for once daily for 12 weeks
12021583|NCT00430625|Biological|VPRIV ®,|Intravenous (IV) infusion, every other week via intravenous infusion for 12 months
12021584|NCT00430586|Drug|Botulinum neurotoxin type A, free of complexing proteins|Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
12021585|NCT00430586|Drug|Placebo|Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.
12021586|NCT00430573|Drug|D-cycloserine|Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
12021587|NCT00430573|Drug|Placebo|Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
12021588|NCT00430560|Behavioral|cognitive rehabilitation|computer training
12021589|NCT00430560|Procedure|work therapy|opportunity to work in carefully supervised hospital job
12021590|NCT00430560|Behavioral|work therapy|work therapy
12021591|NCT00430547|Drug|Carbimazole, radio-active iodine (I131)|
12021592|NCT00430534|Biological|EBV vaccine (268664)|
12021593|NCT00430521|Biological|Pandemic influenza vaccine (GSK1119711A)-formulation 1|2 or 3 doses, intramuscular injection, at different time points.
12021594|NCT00430521|Biological|Pandemic influenza vaccine (GSK1119711A)-formulation 2|2 or 3 doses, intramuscular injection, at different time points.
12021595|NCT00430508|Drug|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
12021596|NCT00430508|Drug|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
12021597|NCT00430508|Drug|olmesartan medoxomil/hydrochlorothiazide tablets|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
12021598|NCT00430508|Drug|olmesartan medoxomil/hydrochlorothiazide tablets|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
12021599|NCT00430495|Drug|Atacicept|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
12021600|NCT00430495|Drug|Atacicept|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
12021601|NCT00430495|Drug|Atacicept|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
12021602|NCT00430495|Drug|Placebo matched to atacicept|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
12021603|NCT00430482|Behavioral|Cognitive Behavioral Therapy|12 weekly sessions and 3 booster sessions of cognitive behavioral therapy
12021604|NCT00430482|Behavioral|Individual Counseling|12 weekly sessions and 3 booster sessions of individual counseling
12021605|NCT00430469|Drug|human lactoferrin (hLF1-11)|intravenous 0.5mg in NaCl-solution
12021606|NCT00430456|Procedure|Exercise|Treadmill Training
12021607|NCT00430443|Drug|Liposomal Annamycin|3-day IV infusion
12021608|NCT00430430|Procedure|High MUFA dietary portfolio|high monounsaturated fat background diet to dietary portfolio
12021609|NCT00430430|Procedure|Low MUFA dietary portfolio|low monounsaturated fat background diet to dietary portfolio
12021610|NCT00430404|Other|Collaborative care (Intervention)|Structured shared care with treatment protocol & support
12021611|NCT00430391|Other|DVD Consent|Participants are randomized to DVD enhanced consent that is either high risk or low risk.
12021612|NCT00430391|Other|Routine Control|Participants are assigned to the routine, standard consent.
12021613|NCT00430378|Procedure|Acupuncture|Acupuncture for 20 minutes before the radiation therapy session, 3 days a week for 7 weeks.
12021614|NCT00430378|Other|Standard Care|No Acupuncture.
12021615|NCT00430365|Drug|lenalidomide|oral drug
12021617|NCT00430352|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv every 8 weeks
12021618|NCT00430326|Drug|Avotermin|
12021619|NCT00430313|Procedure|Electro-Stimulation of Yongquan (K1) Acupoint|Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.
12021620|NCT00430313|Procedure|Electro-Stimulation of Yongquan (K1) Acupoint|"Electro-stimulation at a inactive site on the bottom of the foot (a placebo site)."
12021621|NCT00430300|Drug|UK-432,097|Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
12021622|NCT00430300|Drug|Placebo|Capsules containing 100% lactose administered BID using an atomizer device
12021623|NCT00430261|Drug|sunitinib|50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
12021624|NCT00430248|Drug|Febuxostat|Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
12021625|NCT00430248|Drug|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
12021626|NCT00430248|Drug|Allopurinol|"Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months.
~Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily."
12021627|NCT00430235|Drug|BAY 43-9006|BAY 43-9006, 400 mg, PO, BID in a 28-day cycle(morning and evening) Bicalutamide 50 mg po Once daily in a 28-day cycle (morning)
12021628|NCT00430196|Drug|BOTOX®|
12021629|NCT00430196|Drug|Zanaflex®|
12021630|NCT00430183|Drug|docetaxel|75 mg/m^2 will be administered intravenously over one hour on Day 1 of each cycle, every 21 days
12021631|NCT00430183|Drug|LHRH agonist|Given intramuscularly
12021632|NCT00430183|Procedure|surgery|Patients undergo radical prostatectomy with staging pelvic lymphadenectomy.
12021633|NCT00430170|Drug|Dipyridamole|Dipyridamole 2x200mg 7day per os
12021634|NCT00430170|Drug|caffeine|caffeine 4mg/kg iv
12021635|NCT00430157|Drug|GSK256066|
12021636|NCT00430144|Drug|Belotecan(CKD-602)|Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle
12021637|NCT00430131|Procedure|Cognitive Orientation to Occupational Performance|
12021638|NCT00430131|Procedure|Contemporary Treatment Approach|
12021639|NCT00430118|Drug|asparaginase|
12021640|NCT00430118|Drug|cyclophosphamide|
12021641|NCT00430118|Drug|cytarabine|
12021642|NCT00430118|Drug|daunorubicin hydrochloride|
12021643|NCT00430118|Drug|dexamethasone|
12021644|NCT00430118|Drug|doxorubicin hydrochloride|
12021645|NCT00430118|Drug|etoposide|
12021646|NCT00430118|Drug|ifosfamide|
12021647|NCT00430118|Drug|mercaptopurine|
12021648|NCT00430118|Drug|methotrexate|
12021649|NCT00430118|Drug|prednisone|
12021650|NCT00430118|Drug|thioguanine|
12021651|NCT00430118|Drug|vincristine sulfate|
12021652|NCT00430118|Drug|vindesine|
12021653|NCT00430118|Radiation|radiation therapy|
12021654|NCT00430105|Drug|cyclophosphamide|
12021655|NCT00430092|Drug|Difluprednate|
12021656|NCT00430092|Drug|Difluprednate|
12021657|NCT00430092|Drug|Placebo|
12021658|NCT00430079|Drug|etanidazole|Given IV
12021659|NCT00430079|Procedure|conventional surgery|Undergo surgery
12021660|NCT00430079|Other|pharmacological study|Correlative studies
12021661|NCT00430079|Other|laboratory biomarker analysis|Correlative studies
12021662|NCT00430066|Drug|Imatinib Mesylate|400 mg/die for 6 months
12021663|NCT00430053|Genetic|gene rearrangement analysis|
12021664|NCT00430053|Genetic|polymerase chain reaction|
12021665|NCT00430053|Genetic|proteomic profiling|
12021666|NCT00430053|Other|flow cytometry|
12021667|NCT00430053|Other|immunohistochemistry staining method|
12021668|NCT00430053|Procedure|biopsy|
12021669|NCT00430040|Drug|carvedilol|carvedilol
12021670|NCT00430040|Drug|lisinopril|lisinopril
12021671|NCT00430027|Drug|Capecitabine|Given 650 mg/m^2 BID on days of ration therapy, 825 mg/m^2 day 1-14, day 15-20 off x 4
12021672|NCT00430027|Drug|Oxaliplatin|Oxaliplatin 30 mg/m^2, 130mg/m2 IV Q 21 days x 4
12021673|NCT00430027|Drug|Cetuximab|Initial Cetuximab 400 mg/m^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection
12021674|NCT00430014|Drug|Atiprimod|Starting Dose of 60 mg/day orally for 14 days of 28 day cycle.
12021675|NCT00430001|Drug|docetaxel|
12021676|NCT00430001|Drug|vinorelbine|
12021677|NCT00430001|Drug|trastuzumab|
12021678|NCT00429988|Genetic|fluorescence in situ hybridization|
12021679|NCT00429988|Genetic|polymerase chain reaction|
12021680|NCT00429988|Genetic|proteomic profiling|
12021681|NCT00429988|Other|cytology specimen collection procedure|
12021682|NCT00429988|Other|immunohistochemistry staining method|
12021683|NCT00429988|Procedure|breast duct lavage|
12021684|NCT00429975|Drug|levofloxacin|
12021685|NCT00429975|Drug|ceftriaxone|
12021686|NCT00429962|Drug|intravitreal ranibizumab|intraocular injection
12021687|NCT00429962|Drug|intravitreal ranibizumab & photodynamic therapy|intraocular injection photodynamic treatment (LASER) after intravenous injection
12021688|NCT00429949|Drug|Dasatinib|
12021689|NCT00429936|Drug|Fenretinide|Once daily 30 minutes after the evening meal for 24 months
12021690|NCT00429923|Drug|Difluprednate|
12021691|NCT00429923|Drug|Difluprednate|
12021692|NCT00429923|Drug|Placebo|
12021693|NCT00429897|Drug|Bendroflumethiazide 2.5mg - 5mg|
12021694|NCT00429897|Drug|Amiloride 20-40mg|
12021695|NCT00429897|Drug|Spironolactone 50-100mg|
12021696|NCT00429897|Drug|Frusemide 20-40mg|
12021697|NCT00429897|Drug|Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined|
12021698|NCT00429871|Drug|Docetaxel|Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
12021699|NCT00429871|Drug|Capecitabine|Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
12021700|NCT00429871|Drug|Epirubicin|Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
12021701|NCT00429871|Drug|Docetaxel|Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
12021702|NCT00429858|Drug|S-1|S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)
12021703|NCT00429858|Drug|gemcitabine hydrochloride|Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle
12021704|NCT00429845|Behavioral|Nutritional|
12021705|NCT00429832|Drug|Ondansetron|
12021706|NCT00429832|Drug|promethazine|
12021707|NCT00429806|Drug|DHEA|DHEA
12021708|NCT00429806|Drug|Placebo|Placebo
12021709|NCT00429793|Drug|temsirolimus|Given IV
12021710|NCT00429780|Biological|Alum-ALM + BCG|Alum-ALM + BCG 200 ug per injection
12021711|NCT00429754|Drug|Aprepitant|
12021712|NCT00429728|Drug|GW876008|
12021713|NCT00429715|Biological|Alum-ALM + BCG|Alum precipitated autoclaved L. major
12021714|NCT00429715|Biological|Alum-ALM + BCG|Arm 1=Alum-ALM + BCG Arm 2=BCG Arm 3=Placebo comparator
12021715|NCT00429715|Biological|Alum-ALM + BCG|Alum-ALM + BCG
12021716|NCT00429702|Drug|Decadron®|Given IV
12021717|NCT00429702|Drug|Benadryl®|Given IV
12021718|NCT00429702|Drug|Ativan®|Given IV
12021719|NCT00429702|Drug|ondansetron hydrochloride|Given IV
12021720|NCT00429689|Procedure|Saliva sample|
12021721|NCT00429676|Drug|Haloperidol|
12021722|NCT00429663|Device|reamed, interlocking intramedullary nail|Standard of care device for femur fracture repair
12021723|NCT00429663|Device|locking periarticular plate|Standard of care device for femur fractures
12021724|NCT00429650|Behavioral|increased exercise|Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.
12021725|NCT00429650|Behavioral|diet|Use a prescribed diet to maintain weight loss
12021726|NCT00429650|Behavioral|Exercise and Diet|Use a combination of exercise and diet to maintain weight loss.
12021727|NCT00429624|Procedure|Chiropractic manipulation|
12021728|NCT00429624|Drug|acetaminophen|
12021729|NCT00429611|Procedure|Cardiac defibrillation at high energy vs low energy levels|Defibrillation with progressive high-energy biphasic shocks at 200J, 300J and 360J or low-energy biphasic shocks at 150J, 150J and 150J.
12021730|NCT00429585|Device|reamed, interlocking intramedullary nail|Standard of care device for tibia fracture repair; Randomized Treatment - Nail
12021731|NCT00429585|Device|locking periarticular plate|Standard of care device for tibia fracture repair; Randomized Treatment - Plate
12021732|NCT00429572|Drug|Fludarabine|30 mg/m^2 intravenously Daily for 5 Days
12021733|NCT00429572|Drug|Melphalan|70 mg/m^2 intravenously Daily for 2 Days
12021734|NCT00429572|Procedure|Stem Cell Infusion|Stem Cell Infusion on Day 0.
12021735|NCT00429559|Drug|Hycamptin|1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
12021736|NCT00429559|Drug|Gemcitabine|"Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks.
~Number of cycles: until progression"
12021737|NCT00429546|Behavioral|Teaching, Raising, and Communicating with Kids (TRACK)|TRACK is cognitive-behavioral treatment designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child. The treatment consists of three 75-minute sessions that focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure.
12021738|NCT00429546|Other|Treatment as usual|Treatment as usual includes standard care for HIV infected mothers.
12021739|NCT00429533|Drug|Dapsone|
12021740|NCT00429520|Drug|Hyaluronic acid filler/IMD1 basic|
12021741|NCT00429507|Drug|153 Sm-EDTMP|Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
12021742|NCT00429507|Behavioral|Questionnaire|Questionnaires taking about 15 minutes to complete.
12021743|NCT00429507|Procedure|Stem Cell Transplant|Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
12021744|NCT00429494|Drug|Leuprolide Acetate|22.5 mg IM injection 2 months before transplant and 3 months post-transplant.
12021745|NCT00429494|Behavioral|Questionnaire|Questionnaires taking about 15 minutes to complete.
12021746|NCT00429494|Procedure|Hematopoietic Stem Cell Transplantation|Stem cell infusion on Day 0.
12021747|NCT00429481|Biological|Rotarix|
12021748|NCT00429468|Drug|Vicodin® CR (extended-release hydrocodone/acetaminophen)|
12021749|NCT00429455|Behavioral|Survey|3-Part Questionnaire
12021750|NCT00429442|Drug|Simvastatin|80 mg once daily
12021751|NCT00429442|Drug|placebo|calcium tablets once daily
12021752|NCT00429429|Procedure|Sublingual immunotherapy|Drops of peanut protein placed and held under the tongue for a specific time before swallowed.
12021753|NCT00429416|Drug|L-leucyl-L-leucine Methyl Ester (LLME)|Infusion of L-leucyl-L-leucine methyl ester (LLME) treated donor white blood cells
12021754|NCT00429416|Drug|Fludarabine|Fludarabine 30 mg/m2 prior to HSCT infusion
12021755|NCT00429416|Drug|Cytarabine|Cytarabine 2gm/m2 prior to HSCT infusion
12021756|NCT00429416|Drug|Cyclophosphamide|Cyclophosphamide 1gm/m2 prior to HSCT infusion
12021757|NCT00429416|Drug|Tacrolimus|Tacrolimus given before and after HSCT infusion
12021758|NCT00429416|Drug|Mesna|Mesna 1gm/m2/day given prior to HSCT infusion.
12021759|NCT00429416|Biological|Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)|GM-CSF given post HSCT infusion
12021760|NCT00429416|Procedure|Hematopoietic stem cell transplantation (HSCT)|CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells
12021761|NCT00429403|Drug|Goserelin|3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
12021762|NCT00429390|Behavioral|Ramadan Fasting|
12021763|NCT00429377|Drug|tacrolimus|
12021764|NCT00429364|Drug|Losartan Potassium|Losartan .3 - 1.4 mg/kg
12021765|NCT00429364|Drug|Atenolol|Atenolol .5 - 4 mg/kg
12021766|NCT00429338|Procedure|AIR-MRSI|3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with an air-filled endorectal coil (AIR-MRSI).
12021767|NCT00429338|Procedure|PFC-MRSI|3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with a perfluorocarbon compound (PFC)-filled endorectal coil (PFC-MRSI).
12021768|NCT00429312|Biological|JX-594|Thymidine kinase-deleted vaccinia virus plus GM-CSF
12021769|NCT00429299|Drug|lapatinib|Arm B 1250mg/d PO Arm C 750mg/d PO
12021770|NCT00429299|Biological|trastuzumab|First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins
12021771|NCT00429299|Drug|paclitaxel|80mg/sqm 1 hour infusion for 12 weeks
12021772|NCT00429299|Drug|fluorouracil|600mg/sqm iv day 1 q21 days for four coursess
12021773|NCT00429299|Drug|epidoxorubicin|75mg/sqm iv day 1 q21 days for four courses
12021774|NCT00429299|Drug|cyclophosphamide|600mg/sqm day 1 q21 days for four courses
12021775|NCT00429286|Behavioral|Problem Solving Training|A systematic cognitive-behavioral intervention teaching problem solving skills for addressing functional impairment related to breast cancer and its treatment.
12021776|NCT00429273|Drug|Guanfacine|Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures
12021777|NCT00429273|Drug|Methylphenidate (MPH)|Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.
12021778|NCT00429260|Drug|Saredutant|
12021779|NCT00429247|Drug|Trastuzumab|Trastuzumab,first administration at the dose of 8mg/Kg IV, subsequent administrations at the dose of 6mg/Kg IV,every 3 weeks for 6 cycles
12021780|NCT00429234|Drug|Dasatinib|Starting dose 70 mg by mouth daily for Week 1. Cycle is 28 days, except Cycle 1 which is 8 weeks.
12021781|NCT00429234|Drug|Gemcitabine|Starting dose of 800 mg/m^2 by vein once weekly over 30 minutes beginning Cycle 1 Day 1. All other cycles once weekly for 7 weeks on Days 8, 15, 22, 29, 36, and 43. Cycle is 28 days, except Cycle 1 which is 8 weeks.
12021782|NCT00429221|Behavioral|Tailored Medication Messages for Parents|
12021783|NCT00429208|Drug|Nicotine|
12021784|NCT00429195|Behavioral|Dietary Fatty Acid Modification|
12021785|NCT00429182|Drug|Carboplatin|Target Area Under the Curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
12021786|NCT00429182|Drug|Cyclophosphamide|1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
12021787|NCT00429182|Drug|Thiotepa|120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
12021788|NCT00429182|Procedure|Stem Cell Transplant|Stem Cell Transplant on Day 0.
12021789|NCT00429169|Drug|Paroxetine|Dosage will be 25 mg every day for 2 weeks, then 37.5 mg every day for 2 weeks, and then optional increase to 50 mg every day for the remainder of treatment.
12021790|NCT00429169|Drug|Bupropion|Dosage will be 150 mg every day for 2 weeks, then 300 mg every day for 2 weeks, and then optional increase to 450 mg every day for the remainder of treatment.
12021791|NCT00429156|Device|Home non-invasive ventilation|Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home NIV for 1 year.
12021792|NCT00429156|Device|Home non-invasive ventilation (sham)|Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home sham NIV (CPAP 5 cm H2O) for 1 year.
12021793|NCT00429143|Radiation|Total Body Irradiation (TBI)|TBI twice daily days 6-9 prior to transplant (HSCT)
12021794|NCT00429143|Biological|Donor Lymphocyte Infusion (DLI)|DLI given 6 days prior to transplant (HSCT).
12021795|NCT00429143|Drug|Cyclophosphamide (CY)|Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).
12021796|NCT00429143|Drug|Tacrolimus|Tacrolimus given one day prior to transplant (HSCT).
12021797|NCT00429143|Drug|Mycophenolate Mofetil (MMF)|MMF given one day prior to transplant (HSCT).
12021798|NCT00429143|Biological|Hematopoietic Stem Cell Transplant (HSCT)|CD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed. This is the day of transplantation.
12021799|NCT00429117|Behavioral|Survey|Internet survey lasting 30 to 40 minutes.
12021800|NCT00429104|Drug|Herceptin|4 mg/kg IV Over 90 Minutes
12021801|NCT00429104|Drug|GM-CSF|250 mcg/m^2 Subcutaneously
12021802|NCT00429091|Drug|ABT-894|Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
12021803|NCT00429091|Drug|atomoxetine|Subjects will take 40 mg BID or placebo for up to four weeks.
12021804|NCT00429091|Drug|placebo|Subjects will take BID for up to four weeks
12021805|NCT00429078|Genetic|2nd Generation Designer T Cells|
12021806|NCT00429065|Drug|Rituximab|
12021807|NCT00429039|Drug|L-leucyl-L-leucine methyl ester (LLME)|
12021808|NCT00429026|Drug|Fludarabine|25 mg/m^2 intravenous (IV) daily for 5 Days
12021809|NCT00429026|Drug|Melphalan|70 mg/m^2 IV Daily for 2 Days
12021810|NCT00429026|Drug|Cyclophosphamide|60 mg/kg IV Daily for 2 Days
12021811|NCT00429026|Procedure|Stem Cell Transplant|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor
12021812|NCT00429013|Device|Tongue Display Unit|lingual electric stimulation
12021813|NCT00429000|Device|thermospot|
12021814|NCT00428974|Drug|CF101 1mg|CF101 1 mg q12 hours for 12 weeks
12021815|NCT00428974|Drug|CF101 2mg|CF101 2 mg q12 hours for 12 weeks
12021816|NCT00428974|Drug|CF101 4mg|CF101 4 mg q12 hours for 12 weeks
12021817|NCT00428974|Drug|Placebo|Placebo tablets q12 hours for 12 weeks
12021818|NCT00428948|Drug|Tolvaptan|Tolvaptan was supplied as tablets.
12021819|NCT00428948|Drug|Placebo|Placebo was supplied as tablets.
12021820|NCT00428935|Biological|rAAV2.5-CMV-minidystrophin (d3990)|Recombinant adeno-associated virus (AAV) carrying a truncated human dystrophin gene (mini-dystrophin) expressed from a cytomegalovirus (CMV) promoter.
12021870|NCT00428558|Drug|Chemotherapy (DAUNORUBICINE-CYTARABINE)|A Phase 3 Trial of Systematic versus Response-adapted Timed-SEQUENTIAL Induction in Patients with Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)
12021821|NCT00428922|Drug|Trastuzumab|administered every three weeks on day 1, every 21 days. The dose given will be 6 mg/kg. The initial loading dose is 8mg/kg and is administered as a 90-minute infusion. Thereafter, the maintenance dose is 6mg/kg every three weeks administered as a 30 minute infusion (unless the treating physician indicates a longer infusion duration is warranted). Trastuzumab is given prior to bevacizumab. Trastuzumab is to be continued until disease progression or unacceptable toxicity.
12021822|NCT00428922|Drug|Bevacizumab|administered every three weeks on day 1, every 21 days. The dose given will be 15 mg/kg. The initial dose is administered over 90 minutes. If the first infusion is well tolerated, the second dose is given over 60 minutes, and if that is well tolerated, then subsequent doses may be given over 30 minutes. Avastin is given after trastuzumab and prior to docetaxel.
12021823|NCT00428922|Drug|Docetaxel|administered every three weeks on day 1, every 21 days. The dose given will be 75 mg/M². All doses of docetaxel are administered over 60 minutes. Docetaxel is given after trastuzumab and bevacizumab.
12021824|NCT00428909|Drug|Imatinib/Acetaminophen|
12021825|NCT00428896|Drug|ZD1839|ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
12021826|NCT00428883|Drug|N-acetylcysteine (NAC)|
12021827|NCT00428870|Procedure|Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)|
12021828|NCT00428857|Procedure|non invasive ventilation|non invasive ventilation
12021829|NCT00428844|Drug|daptomycin|6 mg/kg
12021830|NCT00428844|Drug|daptomycin|8 mg/kg
12021831|NCT00428844|Drug|vancomycin|1 gram
12021832|NCT00428844|Drug|teicoplanin|6 mg/kg; used only at UK sites
12021833|NCT00428844|Drug|nafcillin|1-2 gram
12021834|NCT00428844|Drug|oxacillin|1-2 gram
12021835|NCT00428844|Drug|flucloxacillin|1-2 mg
12021836|NCT00428818|Drug|trimethoprim-sulfamethoxazole or doxycycline|
12021837|NCT00428805|Behavioral|classroom curriculum|"classroom curriculum for 3 & 4 year old children includes activities to increase intake of fruits, vegetables, & whole grains; increase physical activity; decrease intake of fats and sugared drinks; and decrease screen time following monthly learning modules.
~Teachers are trained to carry out the classroom curriculum."
12021838|NCT00428805|Behavioral|In-service training for Head Start teachers/aides|Teachers and teacher aides are trained quarterly by certified trainers and receive a certificate for participating in the training. Topics include the content as well as developmental concepts.
12021839|NCT00428805|Behavioral|Training for Head Start food service|Food service workers are trained (quarterly) to modify food ordering, food preparation, and food serving to match the aims of the study
12021840|NCT00428805|Behavioral|Family intervention component|Families receive the CHILE intervention quarterly at Family Events. These include family activities to increase intake of fruits, vegetables, whole grains, decrease intake of fats and sugared drinks, increase of physical activity and decrease screen time. Parenting skills are also included.
12021841|NCT00428805|Behavioral|Food source|The grocery store component includes field trips, self labeling, and taste testing of promoted foods.
12021842|NCT00428805|Behavioral|Health care providers|The health care provider component includes the health care providers presenting at the Family Events and reinforcing the CHILE intervention message in the practice setting when talking with families of head start children.
12021843|NCT00428805|Behavioral|CHILE Head Start Intervention|There are six components of this transcommunity social-ecological intervention including a classroom curriculum, health care provider component, family component, training of Head Start teachers/aides, training of food service staff and grocery store component.
12021844|NCT00428792|Drug|Methylphenidate 20 mg long-acting capsules|
12021845|NCT00428779|Procedure|running during 24 hours without sleep|patients running during 24 hours without sleep
12021846|NCT00428779|Other|no sleeping|patients without sleep during 24 hours
12021847|NCT00428766|Drug|MORAb-003|
12021848|NCT00428727|Drug|Controlled nitric oxide releasing patch|daily application of nitric oxide patch during 90 days
12021849|NCT00428727|Drug|placebo patch|daily application during 90 days
12021850|NCT00428714|Drug|enzastaurin|Administered orally
12021851|NCT00428701|Drug|Esomeprazole Sodium|
12021852|NCT00428662|Device|drug eluting nonpolymeric nanoporous stent|
12021853|NCT00428649|Dietary Supplement|20 µg selenium|20 µg selenium as selenomethionine
12021854|NCT00428649|Dietary Supplement|40 µg selenium|40 µg selenium as selenomethionine
12021855|NCT00428649|Dietary Supplement|60 µg selenium|60 µg selenium as selenomethionine
12021856|NCT00428649|Dietary Supplement|80 µg selenium|80 µg selenium as selenomethionine
12021857|NCT00428649|Dietary Supplement|100 µg selenium|100 µg selenium as selenomethionine
12021858|NCT00428649|Dietary Supplement|120 µg selenium|120 µg selenium as selenomethionine
12021859|NCT00428649|Dietary Supplement|placebo|placebo
12021860|NCT00428636|Procedure|ileostomy|
12021861|NCT00428623|Procedure|wound dressing|
12021862|NCT00428610|Drug|LY573636-sodium|LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met.
12021863|NCT00428597|Drug|sunitinib malate|"sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
~Dose may be decreased to 25 mg daily in case of adverse events.
~It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
~Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination."
12021864|NCT00428597|Drug|Placebo|Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.
12021865|NCT00428584|Drug|New Formulation of rebif - human interferon beta-1a|New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.
12021866|NCT00428584|Drug|Interferon beta -1b|Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.
12021867|NCT00428571|Procedure|laparoscopic gastric bypass surgery|Laparoscopic Gastric Bypass Surgery
12021868|NCT00428571|Procedure|laparoscopic adjustable gastric banding|laparoscopic adjustable gastric banding
12021869|NCT00428571|Procedure|Intensive Medical Management|lifestyle, diet, medication optimization
12021871|NCT00428558|Drug|Chemotherapy (DAUNORUBICINE-CYTARABINE)|Chemotherapy induction sequential
12021872|NCT00428545|Drug|Bevacizumab|Starting Dose 2.5 mg/kg By Vein On Day 1 Every 21 Days
12021873|NCT00428545|Drug|Bortezomib|Starting Dose 0.7 mg/m^2 By Vein On Days 1 and 8 Every 21 Days
12021874|NCT00428532|Drug|Licorice root extract or Pomegranate juice|
12021875|NCT00428519|Drug|Placebo|Placebo for 14 days
12021876|NCT00428519|Drug|Aprepitant|Aprepitant at a dose of 125 mg daily for 14 days
12021877|NCT00428519|Drug|Aprepitant|Aprepitant at a dose of 250 mg daily for 14 days
12021878|NCT00428506|Drug|albumin 4 gr/L ascites removed|albumin 4 gr/L ascites removed
12021879|NCT00428506|Drug|albumin 8 gr/L ascites removed|albumin 8 gr/L ascites removed
12021880|NCT00428480|Behavioral|Daily reinforcement of walking speed (DRS)|Inpatients are encouraged to walk faster and given feedback on their walking speed during a daily 10-meter walk as part of their usual physical therapy.
12021881|NCT00428480|Behavioral|No reinforcement of walking speed (NRS)|Inpatients complete a 10-meter walk as part of their daily physical therapy but are not given any encouragement to walk faster or feedback on their walking speed.
12021882|NCT00428467|Procedure|LV Apex Compression|
12021883|NCT00428454|Device|sirolimus-eluting stent, zotarolimus-eluting stent|PCI in chronically occluded coronary artery
12021884|NCT00428441|Drug|Warfarin|tablets, based on INR levels, according to D-dimer levels
12021885|NCT00428428|Drug|Isoproterenol|ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation
12021886|NCT00428415|Drug|Tesofensine|
12021887|NCT00428402|Behavioral|Focus Group Discussion|Focus groups meeting for up to 1 hour during the regular school day.
12021888|NCT00428389|Drug|Rivastigmine 5 cm^2 transdermal patch|Rivastigmine 5 cm^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours.
12021889|NCT00428389|Drug|Rivastigmine 10 cm^2 transdermal patch|Rivastigmine 10 cm^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.
12021890|NCT00428376|Device|Building Blocks|
12021891|NCT00428363|Device|Cataract surgery with implantation of an intraocular lens|
12021892|NCT00428350|Drug|Quetiapine Fumarate (Seroquel)|
12021893|NCT00428337|Biological|EP-1233|DNA-HIV-recombinant vaccine
12021894|NCT00428337|Biological|MVA-mBN32|HIV-recombinant viral vaccine
12021895|NCT00428311|Drug|Metformin|
12021896|NCT00428311|Drug|Ethynyl-estradiol plus cyproterone acetate|
12021897|NCT00428298|Drug|Valacyclovir|Subjects take two 500 mg capsules twice daily for 16 weeks.
12021898|NCT00428298|Drug|Placebo|Subjects take two 500 mg capsules twice daily for 16 weeks.
12021899|NCT00428285|Procedure|Argon Plasma Coagulation|Argon Plasma Coagulation (APC) is a non-contact electrosurgical technique delivering a high-frequency electrical current through ionized argon gas i.e. the argon plasma. This current produces a zone of coagulation, desiccation, and devitalisation 2-3 mm deep. Patients will be offered up to 3 treatments if recurrence occur after the first two.
12021900|NCT00428272|Drug|Lexatumumab alone|Dose escalation : 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kg
12021901|NCT00428272|Drug|Lexatumumab in combination|Dose escalation : 1mg/kg, 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kg
12021902|NCT00428272|Drug|Interferon gamma 1b in combination|Dosing at the following for each lexatumumab dose level: .75mcg/m2/dose and 25mcg/m2/dose
12021903|NCT00428272|Drug|Gamma 1b potential expansion|Potential expansion (at 10mg/kg lexatumumab): 1.5mcg/m2/dose and 50mcg/m2/dose
12021904|NCT00428246|Drug|paricalcitol|1 mcg or 2 mcg for 4 weeks.
12021905|NCT00428246|Drug|Placebo|Placebo
12021906|NCT00428233|Procedure|Leukemia cell harvest|Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node
12021907|NCT00428220|Drug|sunitinib|sunitinib
12021908|NCT00428207|Drug|Insulin Aspart versus Insulin Lispro|Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.
12021909|NCT00428207|Drug|Insulin Lispro versus Insulin Aspart|Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients.
12021910|NCT00428194|Drug|cisplatin|40 mg/m^2 every 7 days during radiation
12021911|NCT00428194|Drug|erlotinib hydrochloride|Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
12021912|NCT00428194|Procedure|radiation therapy|standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
12021913|NCT00428181|Behavioral|Brief alcohol intervention|Brief alcohol intervention
12021914|NCT00428181|Behavioral|Brief alcohol intervention plus booster|Brief alcohol intervention plus booster in a later session
12021915|NCT00428168|Drug|Betahistine|Betahistine 24mg BID
12021916|NCT00428155|Device|closure device placement|
12021917|NCT00428142|Biological|rituximab|375mg/m2 day 1
12021918|NCT00428142|Drug|bortezomib|1.3mg/m2 days 1 & 8
12021919|NCT00428142|Drug|cyclophosphamide|750mg/m2 day 1
12021920|NCT00428142|Drug|prednisone|40mg/m2 days 1-5
12021921|NCT00428142|Drug|vincristine sulfate|1.4mg/m2 day 1 (dose capped at 2mg)
12021922|NCT00428129|Drug|microplasmin|20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length
12021923|NCT00428116|Drug|HAART|Combination first line antiretrovirals as previously described.
12021924|NCT00428103|Procedure|3 dimensional echocardiography|Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram
12021925|NCT00428090|Drug|Rosiglitazone|XR (extended release) oral tablets
12021926|NCT00428077|Biological|bcr-abl peptide vaccine|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic break-point cluster region-Abelson murine leukemia(BCR-ABL) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
12021975|NCT00427752|Procedure|Transgastric endoscopic peritoneoscopy.|Exploration of the abdominal area
12021976|NCT00427739|Procedure|Cardiac CT|64 slice spiral computerized tomography
12021977|NCT00427713|Drug|capecitabine|
12021927|NCT00428077|Genetic|reverse transcriptase-polymerase chain reaction|"A baseline reverse transcriptase-polymerase chain reaction(RT-PCR) transcript level of BCR-ABL will be determined after enrollment on study. This baseline will be used to measure response to the vaccine. Patients will have 3 quantitative RT-PCR tests for BCR-ABL transcript levels performed on their peripheral blood in the first month after enrolling on study. Peripheral blood samples will be drawn at approximately 1-month prior (about day -30), 2 weeks prior (about day -14), and the day of the first vaccination (day 0). Samples will be analyzed at a central lab and the three values will be averaged to determine a baseline circulating transcript level. During this one-month period, a peripheral blood sample will be analyzed to determine whether patients have a B3A2 or B2A2 junction."
12021928|NCT00428064|Drug|Sirolimus|
12021929|NCT00428064|Drug|cyclosporine|
12021930|NCT00428051|Other|Surveillance|No study drug, only interventions are blood draws and Chest X-rays
12021931|NCT00428025|Drug|diclofenac|100 mg diclofenac rectal suppository
12021932|NCT00428025|Drug|placebo|similar shape and size suppository
12021933|NCT00428012|Behavioral|Quality of Life Therapy|8 weekly individual counseling sessions
12021934|NCT00428012|Behavioral|Supportive Therapy|8 weekly individual counseling sessions
12021935|NCT00427999|Drug|imatinib mesylate|
12021936|NCT00427999|Drug|Treosulfane|
12021937|NCT00427999|Drug|etoricoxib|
12021938|NCT00427999|Drug|pioglitazone|
12021939|NCT00427999|Drug|dexamethasone|
12021940|NCT00427986|Drug|Galactose, intravenous|
12021941|NCT00427973|Drug|cediranib maleate|Given orally
12021942|NCT00427973|Other|laboratory biomarker analysis|Peripheral blood was obtained from all patients enrolled for studies of early changes in circulating proangiogenic and proinflammatory molecules and cells. Blood samples were collected in EDTA-containing tubes before and after cediranib therapy on days 1 and 14 of cycle 1. Circulating VEGF, placental growth factor (PlGF), sVEGFR1, basic fibroblast growth factor (bFGF), interleukin (IL)-6, IL-8, transforming growth factor a ((TNF-a), gamma interferon (IFN-g) were measured using multiplex ELISA plates from Meso-Scale Discovery. Hepatocyte growth factor (HGF), insulin-like growth factor 1 (IGF-1), sVEGFR2, angiopoietin 2 (Ang-2), sTie2, soluble c-KIT, carbon anhydrase 9 (CAIX), and stromal cell-derived factor-1a (SDF1a) were measured using ELISA kits from R&D Systems.
12021943|NCT00427973|Procedure|computed tomography|computed tomography (CT) every 8 weeks to evaluate response and progression.
12021944|NCT00427973|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Magnetic resonance imaging (MRI) every 8 weeks to evaluate response and progression.
12021945|NCT00427973|Other|pharmacological study|Blood samples to characterize the steady-state PK of cediranib were drawn from a peripheral vein shortly before patients received the dose on days 8 and 15 of cycle 1 and at the following times relative to dosing on day 1 of cycle 2: 5 min and 1, 2, 4, 6, 8, and 24 hours, with the last sample collected before taking the next daily dose.
12021946|NCT00427960|Behavioral|Dietary advice|
12021947|NCT00427960|Drug|rosuvastatin|rosuvastatin 5 mg
12021948|NCT00427960|Drug|atorvastatin|atorvastatin 10 mg
12021949|NCT00427947|Drug|ropivacaine/placebo|Continuous sciatic nerve bloc
12021950|NCT00427934|Drug|Maraviroc|300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
12021951|NCT00427934|Drug|Maraviroc Placebo|Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
12021952|NCT00427921|Biological|adalimumab|160 mg loading dose, 80 mg at week 2, 40 mg every other week
12021953|NCT00427908|Biological|GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)|One intramuscular dose.
12021954|NCT00427908|Biological|Mencevax™ ACWY|One subcutaneous dose.
12021955|NCT00427908|Biological|Meningitec™|One intramuscular dose.
12021956|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered on day 1
12021957|NCT00427895|Biological|23-valent Pneumococcal Polysaccharide Vaccine (23vPS)|0.5 mL dose administered on day 1
12021958|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered on day 1
12021959|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered on day 1
12021960|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered 3-4 years after dose 1
12021961|NCT00427895|Biological|23-valent Pneumococcal Polysaccharide Vaccine (23vPS)|0.5 mL dose administered 3-4 years after dose 1
12021962|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered 3-4 years after dose 1
12021963|NCT00427882|Drug|ALFUZOSIN|
12021964|NCT00427856|Drug|Obatoclax mesylate|Obatoclax mesylate 40mg, and 60mg
12021965|NCT00427856|Drug|Rituximab|Rituximab
12021966|NCT00427843|Behavioral|home exercise program for the hip abductor muscles|"All patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. Patients will be instructed in the following program: contraction of the gluteus medius muscle during functional activities (gait, stepping sideways up on a step and standing on one leg); and side lying isotonic hip abduction exercises using graded resistance elastic bands positioned around the distal thighs.
~The program will be performed 3 times per week for 8 weeks and subjects will record exercise frequency and level of resistance on exercise calendars. Follow-up visits will occur at the end of week 1 and week 4 for review and progression of exercises. A telephone follow-up call will occur for support and participants will be encouraged to call with any questions or concerns."
12021967|NCT00427830|Biological|MVA85A|
12021968|NCT00427804|Drug|calcitriol|0.25 mcg PO BID for 1 week for low dose then 0.25 mcg PO BID for high dose
12021969|NCT00427791|Drug|Etoposide|60 mg/kg IV Daily Over 4 Hours for 1 Day
12021970|NCT00427791|Radiation|Total Body Irradiation|3 Gy Daily for 4 Days
12021971|NCT00427791|Drug|Rituximab|375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
12021972|NCT00427778|Device|incontinence ring|"Incontinence ring fitted to patient's anatomy (by choosing appropriate size). It is worn continually for the duration of the treatment period.
~Intravaginal incontinence ring placed proximally in the posterior vaginal fornix. Knob located at mid-urethra."
12021973|NCT00427765|Drug|Busulfan|Test Dose = 32 mg/m^2 IV for 1 Day; 130 mg/m^2 IV for 4 Days
12021974|NCT00427765|Drug|Melphalan|70 mg/m^2 IV for 2 Days
12021979|NCT00427713|Procedure|adjuvant therapy|
12021980|NCT00427713|Procedure|standard follow-up care|
12021981|NCT00427700|Drug|clomiphene citrate|100mg PO on days 5-9 of the menstrual cycle
12021982|NCT00427700|Drug|raloxifene|100mg PO on days 5-9 of the menstrual cycle
12021983|NCT00427687|Drug|AGG-523|
12021984|NCT00427674|Drug|[123I] mZINT injection and serial dynamic SPECT imaging|Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKG.
12021985|NCT00427661|Other|Busulfan; Fludarabine; cyclosporine A and MMF|Hematopoietic stem cell transplantation from a matched sibling or unrelated donor following a reduced intensity conditioning regimen
12021986|NCT00427648|Drug|alkalinized xylocaine|30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks
12021987|NCT00427648|Drug|placebo|normal saline
12021988|NCT00427635|Drug|Esomeprazole|
12021989|NCT00427622|Other|physiologic testing|
12021990|NCT00427609|Drug|Bicillin L-A|Bicillin L-A administered intramusculary in a dose of 2.4 million units every three weeks or normal saline injection administered intramusculary in a dose of 3 cc every three weeks
12021991|NCT00427596|Drug|Solabegron|
12021992|NCT00427583|Drug|imatinib mesylate|
12021993|NCT00427570|Biological|BCG vaccine|
12021994|NCT00427570|Biological|biological therapy|
12021995|NCT00427570|Drug|fluorouracil|
12021996|NCT00427570|Drug|semustine|
12021997|NCT00427570|Drug|vincristine sulfate|
12021998|NCT00427557|Drug|Fludarabine|30 mg/m^2 by vein for 4 Days (Day -10 through Day -7).
12021999|NCT00427557|Drug|Melphalan|140 mg/m^2 by vein for 1 Day (Day -7).
12022000|NCT00427557|Procedure|Umbilical Cord Blood|1 UCB Unit by vein on Day -5.
12022001|NCT00427557|Drug|Rituximab|375 mg/m^2 by vein once weekly (Days -7, -1, +7, +14) for 4 Weeks (if appropriate).
12022002|NCT00427557|Other|Peripheral Blood Stem Cell Infusion|Infusion of blood stem cells on Day 0.
12022003|NCT00427544|Drug|PRA-027|
12022004|NCT00427531|Other|physiologic testing|
12022005|NCT00427505|Drug|Deferasirox|
12022006|NCT00427492|Drug|Magnesia|Tablet magnesia 500mg. 2 tablet 2 times a day for a week
12022007|NCT00427492|Drug|Placebo|
12022008|NCT00427466|Drug|Pemetrexed|
12022009|NCT00427453|Biological|MVA85A|
12022010|NCT00427440|Drug|AMG 102 at 20 mg/kg|AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks
12022011|NCT00427440|Drug|AMG 102 at 10 mg/kg|AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
12022012|NCT00427427|Drug|Trastuzumab|
12022013|NCT00427414|Drug|liposomal daunorubicin citrate|40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
12022014|NCT00427401|Drug|PF-00915275|
12022015|NCT00427388|Drug|Methylprednisolone|Given by IV in 2 doses (250 mg each dose for a total of 500 mg)
12022016|NCT00427388|Other|Placebo|Given in 2 IV doses (approximately 4 ml of 0.9% normal saline solution in each dose)
12022017|NCT00427375|Procedure|local rectal excision|New surgical option in good responders after neoadjuvant treatment for low rectal cancer
12022018|NCT00427375|Procedure|total mesorectal excision|standard surgery
12022019|NCT00427362|Drug|Adalimumab|
12022020|NCT00427349|Drug|AMG 706|AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment
12022021|NCT00427349|Drug|octreotide|One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.
12022022|NCT00427336|Drug|Fludarabine|30 mg/m^2 by vein daily over 30 minutes
12022023|NCT00427336|Drug|Cyclophosphamide|300 mg/m^2 by vein daily over 2 hours
12022024|NCT00427336|Drug|Antithymocyte Globulin|3.75 mg/kg by vein daily over 4 hours
12022025|NCT00427323|Procedure|light exposure|
12022026|NCT00427310|Drug|fluorouracil|
12022027|NCT00427310|Other|Observation|
12022028|NCT00427310|Drug|sodium heparin|
12022029|NCT00427297|Drug|AZT/3TC/NVP (zidovudine/lamivudine/nevirapine)|First line regimen
12022030|NCT00427297|Drug|d4T/3TC/NVP (stavudine/lamivudine/nevirapine)|First line regimen
12022031|NCT00427297|Drug|AZT/3TC/ABC (zidovudine/lamivudine/abacavir)|First line regimen
12022032|NCT00427297|Drug|d4T/3TC/ABC (stavudine/lamivudine/abacavir)|First line regimen For children who have anaemia(Hb of<8g/dl), AZT will be substituted for d4T.
12022033|NCT00427297|Drug|ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir)|Second line regimen
12022034|NCT00427297|Drug|ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz)|Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
12022035|NCT00427297|Drug|ABC/3TC/NVP (abacavir/lamivudine/nevirapine)|First line regimen
12022036|NCT00427271|Drug|aspirin|
12022037|NCT00427258|Drug|MOA-728|
12022038|NCT00427245|Drug|cyclophosphamide|
12022039|NCT00427245|Drug|goserelin acetate|
12022040|NCT00427245|Procedure|adjuvant therapy|
12022041|NCT00427245|Procedure|fertility assessment and management|
12022042|NCT00427245|Procedure|neoadjuvant therapy|
12022043|NCT00427232|Drug|BQ-123 and BQ-788|
12022044|NCT00427219|Drug|Ozarelix/Placebo|Ozarelix 15 mg or placebo will be administered IM on Day 0 and Day 14
12022045|NCT00427219|Drug|Placebo|Eligible patients entered a placebo run-in phase in which placebo was administered twice over a 2 week period (Day -28 and Day -14) and patients were assessed to establish baseline values approximately 14 days following the second placebo injection
12022046|NCT00427206|Drug|acetaminophen (4g/day)|
12022047|NCT00427206|Drug|placebo|
12022048|NCT00427193|Behavioral|Caloric Restriction (CR)|Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
12022049|NCT00427193|Behavioral|Control|Participants continue their current diet for 24 months
12022050|NCT00427180|Device|Retinal Implant System (IRIS)|AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina
12022051|NCT00427167|Biological|AMA1-C1/Alhydrogel + CPG 7909 (Saline)|
12022052|NCT00427167|Biological|AMA1-C1/Alhydrogel + CPG 7909 (Phosphate)|
12022053|NCT00427167|Drug|AMA1-C1/Alhydrogel + CPG 7909|
12022054|NCT00427154|Drug|rosiglitazone|Tablets, 4 mg once or twice daily.
12022055|NCT00427154|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
12022056|NCT00427154|Drug|metformin|Tablets, 2000 mg/day.
12022057|NCT00427154|Drug|glimepiride|Tablets, 8 mg/day.
12022058|NCT00427141|Drug|GSK580416|
12022059|NCT00427128|Drug|fluoxetine|10mg/day increased over 12 weeks to 20-80 mg/day; 20-80 mg/day maintained from week 13-36.
12022060|NCT00427128|Drug|placebo|Week 13-36.
12022061|NCT00427115|Behavioral|Multimodal exercise and psychosocial program|
12022062|NCT00427102|Drug|Oral MRX-1024|
12022063|NCT00427102|Procedure|Standard Fractionation Radiation Therapy|
12022064|NCT00427102|Drug|High-Dose Cisplatin Chemotherapy|
12022065|NCT00427089|Drug|Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate|2L gut lavage solution
12022066|NCT00427089|Drug|Sodium Phosphate solution (NaP)|45 ml solution; BID
12022067|NCT00427076|Drug|Cotrimoxazole|Cotrimoxazole arm: intravenous cotrimoxazole 4 amp (320 mg trimethoprim/ 1600 mg sulfamethoxazole) diluted in 500 ml D5W or N.S. Q 12 hours. Patients intolerant of volume overload will be given the same dose in 250ml D5W (as in the current recommendations used in the hospital). The dose was selected basing on the existing randomized controlled trial and a pharmacokinetic study . 21 For patients with GFR< 30 the dosage interval will be increased to 4 amp (320 mg trimethoprim/ 1600 mg sulfamethoxazole) diluted in 500 ml D5W or N.S. Q 24 hours. 22 Patients on peritoneal dialysis will be given 2 amp (160 mg trimethoprim/ 800 mg sulfamethoxazole) Q 48 hours. Patients with acute renal failure treated with hemodialysis will be given the 2 amp (160 mg trimethoprim/ 800 mg sulfamethoxazole) after dialysis. Patients on continuous hemofiltration for acute renal failure will be administered the dose for GFR<30.
12022068|NCT00427076|Drug|Vancomycin|intravenous vancomycin 1gr Q 12 hours. Adjustment to creatinine clearance: GFR 10-50 1 gr Q 24-96 hours, GFR <10 1gr Q 4-7 days.
12022069|NCT00427050|Drug|PEP005|
12022070|NCT00427037|Drug|Cholecalciferol|50,000 IU weekly by mouth
12022071|NCT00427037|Drug|Placebo|identical placebo pill orally by mouth
12022072|NCT00427011|Drug|E2007|E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.
12022073|NCT00426998|Drug|Verteporfin|
12022074|NCT00426998|Drug|Bevacizumab|
12022075|NCT00426985|Drug|Ketoprofen Topical Patch 20%|
12022076|NCT00426972|Drug|estradiol (Zesteem)|
12022077|NCT00426959|Device|Image Guided Dynamic Dosimetry|Image Guided Dynamic Dosimetry
12022078|NCT00426946|Drug|Reboxetine|
12022079|NCT00426933|Drug|Daptomycin|
12022080|NCT00426933|Drug|Vancomycin|
12022081|NCT00426920|Drug|Insulin|
12022082|NCT00426907|Procedure|Unlimited postoperative weightbearing|Unlimited postoperative weightbearing
12022083|NCT00426894|Procedure|samples from nostrils, mouth, axillas, perianal area and postoperative wound|
12022084|NCT00426881|Behavioral|Exercise Training|Twice weekly resistance training for 52 weeks.
12022085|NCT00426881|Behavioral|Exercise training|Once weekly resistance training for 52 weeks.
12022086|NCT00426881|Behavioral|Exercise training|Twice weekly resistance training for 52 weeks.
12022087|NCT00426868|Other|Direct injection of ADRCs into the Left Ventricle|Dose escalation
12022088|NCT00426868|Other|Direct injection of placebo into the Left Ventricle|
12022089|NCT00426855|Drug|Bendamustine|starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w
12022090|NCT00426855|Drug|Bortezomib|weekly 1.5mg/m^2, IV, d1,8,15,22 q5w
12022091|NCT00426842|Drug|Midodrine Hydrochloride|Alpha1-agonist, exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure.
12022092|NCT00426829|Drug|Bevacizumab|10 mg/kg by vein every 14 days +/- 2 days, starting on day 1.
12022093|NCT00426829|Radiation|Proton Radiation Therapy|3 Gy dose/fraction x 20 fractions.
12022094|NCT00426816|Drug|SB-649868|Active compound at doses of 10mg, 30mg and 60mg
12022095|NCT00426816|Drug|Placebo|Placebo to match SB-649868
12022096|NCT00426803|Drug|activated recombinant human factor VII|
12022097|NCT00426790|Procedure|Positive end-expiratory pressure|
12022098|NCT00426777|Drug|risedronate|risedronate 35mg tablet, weekly for 12 months
12022099|NCT00426777|Drug|risedronate|35mg weekly
12022100|NCT00426777|Drug|Control|risedronate-matched placebo weekly
12022101|NCT00426764|Drug|Romidepsin|Romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.
12022102|NCT00426751|Drug|Abciximab|Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI.
12022103|NCT00426751|Drug|Eptifibatide|Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mdg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.
12022104|NCT00426725|Device|EasyLabour|According to the trial protocol
12022105|NCT00426712|Biological|1018 ISS immunostimulatory oligonucleotide with HBV surface antigen|Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
12022106|NCT00426712|Biological|Hepatitis B Vaccine (Recombinant)|IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24
12022107|NCT00426673|Drug|Brivaracetam (ucb34714)|
12022154|NCT00426270|Drug|Octagam 10%|Octagam 10% was supplied as a ready-to-use solution in glass bottles.
12022155|NCT00426257|Procedure|Secondary debulking|Secondary debulking
12022108|NCT00426660|Drug|maraviroc|The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
12022109|NCT00426647|Drug|Buprenorphine|
12022110|NCT00426647|Drug|Tramadol|
12022111|NCT00426621|Drug|Diclofenac Sodium Gel|4 grams per knee, 4 times per day, for 12 weeks
12022112|NCT00426621|Drug|Placebo|4 grams per knee, 4 times per day, for 12 weeks
12022113|NCT00426608|Drug|metyrapone|Metyrapone will be available as 250 mg dose capsule.
12022114|NCT00426608|Drug|alprazolam|Alprazolam capsules will be available with dose strength of 0.25mg
12022115|NCT00426608|Drug|placebo|GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.
12022116|NCT00426608|Drug|GSK561679|GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
12022117|NCT00426595|Drug|Administration of omeprazole suspension|
12022118|NCT00426595|Drug|omeprazole administered as a multi-unit-pellet system|
12022119|NCT00426582|Drug|Patupilone|
12022120|NCT00426556|Drug|Everolimus|Everolimus (RAD001) was supplied as tablets in 3 different dosage strengths, 2.5, 5, and 10 mg. The drug was packaged in blisters containing 10 tablets per blister. Blisters and packaging labels were compliant with local regulations and were printed in local language.
12022121|NCT00426556|Drug|Trastuzumab|Commercially-available trastuzumab was used in this study. A 4 mg/kg loading dose was administered, intra-venous (IV), over 90 minutes on Day 1 (if patient was not already receiving trastuzumab); this was followed by weekly trastuzumab 2 mg/kg IV administered over 30 minutes. For patients who continued to receive trastuzumab and everolimus after completion/discontinuation of chemotherapy in the core treatment phase, trastuzumab may have been administered once every 3 weeks at a dose of 6 mg/kg. PT = Paclitaxel & Trastuzumab
12022122|NCT00426556|Drug|Paclitaxel|Commercially-available paclitaxel was used in this study. Paclitaxel infusion was administered on Days 1, 8, and 15 of each 28-day cycle, after administration of trastuzumab. Paclitaxel (80 mg/m2) was administered as a 60-minute continuous IV infusion after standard premedication. Patients received paclitaxel for 6 cycles. At the investigator's discretion, treatment with paclitaxel could continue beyond 6 cycles.
12022123|NCT00426543|Drug|MabThera (rituximab)|1000 mg infusion twice with 14 days interval
12022124|NCT00426543|Drug|Rituximab, Mabthera|1000 mg Rituximab infusion in 500 ml isotonic sodiumchloride twice with 14 days interval
12022125|NCT00426530|Drug|everolimus (RAD001)|
12022126|NCT00426517|Drug|Fludarabine|For patients with inflammatory disorders or immunodeficiencies with a predominant inflammatory component, we may use Fludarabine instead of TBI to increase the immunosuppression induced by the regimen as well as to try to decrease the target cells responsible for the inflammatory symptoms
12022127|NCT00426517|Drug|Total Body Irradiation, Busulfan, Campath-1H, or h-ATG, Fludarabine|Conditioning regimen in various combination based on patient underlining immune deficiency disorder
12022128|NCT00426517|Drug|Sirolimus or equivalent based on response|post Transplantation immunosuppressants
12022129|NCT00426517|Drug|Granulocyte Colony Stimulating Factor (G-CSF)|For mobilization of sibling donors
12022130|NCT00426517|Other|hematopoietic progenitor cells|Allogeneic Stem Cells (sibling donor, Unrelated Donor (MUD) or Cord Blood Unit (CBU)
12022131|NCT00426504|Procedure|Radiotherapy|Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) with the intend of delivering radical radiotherapy to a dose of 66-70 Gy to involved areas and at least 50 Gy to un-involved sites to be treated prophylactically.
12022132|NCT00426491|Drug|Misoprostol|400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.
12022133|NCT00426478|Drug|Valsartan plus Hydrochlorothiazide (80mg/12.5mg)|
12022134|NCT00426478|Drug|Amlodipine (5mg)|
12022135|NCT00426452|Drug|Vatalinib|
12022136|NCT00426439|Drug|Chloroquine|Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.
12022137|NCT00426439|Drug|Artemether-lumefantrine (Coartem)|Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, < 34 kg: 4 tablets.
12022138|NCT00426426|Behavioral|Cognitive-Behavioural Therapy|12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.
12022139|NCT00426426|Behavioral|Meta-Cognitive Therapy|12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .
12022140|NCT00426426|Behavioral|Waiting list|
12022141|NCT00426413|Drug|pioglitazone|Obese AA subjects with DKA or severe hyperglycemia that are able to discontinue insulin at 12 weeks or less will be randomized (blinded fashion) to receive either placebo or pioglitazone qd. The subjects will be followed while in the study arm and beta-cell function will be assessed using OGTT at set intervals.
12022142|NCT00426400|Drug|The cessation of anti-aggregative treatment for 10 days|
12022143|NCT00426374|Procedure|echocardiography and blood test|
12022144|NCT00426361|Biological|Boostrix ® Polio|One dose of vaccine administered intramuscularly
12022145|NCT00426361|Biological|GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM)|Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively
12022146|NCT00426348|Drug|Valsartan|Valsartan (80-160mg/day)
12022147|NCT00426348|Drug|Probucol|Probucol (750mg/day)
12022148|NCT00426348|Drug|Placebo|Placebo
12022149|NCT00426322|Device|bovine bone mineral particles (Bio-Oss®)|bovine bone mineral particles used for sinus augmentation prior to dental implant placement
12022150|NCT00426296|Drug|atazanavir (Reyataz)|
12022151|NCT00426296|Drug|ritonavir (Norvir)|
12022152|NCT00426283|Drug|Flovent|1760 mcg daily
12022153|NCT00426283|Other|Placebo|Placebo
12022216|NCT00425802|Drug|mycophenolate mofetil|
12022156|NCT00426257|Procedure|secondary debulking with intraperitoneal chemotherapy|secondary debulking with intraperitoneal chemotherapy
12022157|NCT00426244|Other|Osteopathic Manipulative Treatment|OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning.
12022158|NCT00426244|Other|Placebo Ultrasound|"In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT.
~The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects."
12022159|NCT00426231|Behavioral|Navigation by a health worker|Help provided by health worker to navigate medication access programs
12022160|NCT00426231|Behavioral|Information control|Information about medication access programs provided to the participant and their healthcare provider
12022161|NCT00426218|Drug|ACZ885|
12022162|NCT00426205|Biological|GM-CSF secreting leukemia vaccine|Vaccine given subcutaneously or intradermally on the leg, arm, or abdomen 6 times. The first three vaccines will be given once a week for three weeks. The last three vaccines will be given once every other week for three doses.
12022163|NCT00426192|Drug|i.v. mannitol|
12022164|NCT00426192|Procedure|hemofiltration|
12022165|NCT00426179|Drug|Imatinib|
12022166|NCT00426166|Device|Low Level Laser Therapy|Low Level Laser Therapy on Wound
12022167|NCT00426153|Drug|Octreotide|Participants received Octreotide LAR® Depot injections (up to 40 mg)intramuscularly every 28 days (+/- 5 days) for one year
12022168|NCT00426153|Drug|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
12022169|NCT00426140|Drug|Patupilone|
12022170|NCT00426127|Drug|Docetaxel|
12022171|NCT00426127|Drug|Liposomal Doxorubicin|
12022172|NCT00426127|Drug|Enoxaparin|
12022173|NCT00426114|Drug|Administration of an IV glucose-injection|
12022174|NCT00426101|Drug|Dexamethasone|"10 mg/m2 daily wk 1-2 5 mg/m2 daily wk 3-4 2.5 mg/m2 daily wk 5-6 1.25 mg/m2 daily wk 7 Steroids tapered wk 8
~If continuation:
~Pulses every 2nd wk, 10 mg/m2 for 3 days"
12022175|NCT00426101|Drug|Etoposide|"150 mg/m2 iv twice/wk (wk 1-2) 150 mg/m2 iv once/wk (wk 3-8)
~If continuation:
~150 mg/m2 iv, every 2nd wk"
12022176|NCT00426101|Drug|Cyclosporin|"WK 1-8:
~- Aim at around 200 microgram/L (trough value). Start: 6 mg/kg daily (divided in 2 daily doses) wk 1, if kidney function is normal.
~If continuation:
~- Aim for around 200 microgram/L. Monitor GFR."
12022177|NCT00426101|Procedure|Intrathecal therapy|"If at 2 wks there are progressive neurological symptoms or if an abnormal CSF (cell count and protein) has not improved, then give 4 wkly intrathecal inj. Be aware that some pat may have increased intracranial pressure.
~Methotrexate: <1 yr 6 mg, 1-2 yrs 8 mg, 2-3 yrs 10 mg, >3 yrs 12 mg. Prednisolone: <1 yr 4 mg, 1-2 yrs 6 mg, 2-3 yrs 8 mg, >3 yrs 10 mg."
12022178|NCT00426101|Procedure|Stem cell transplant|The SCT procedure is up to the treating physician. However, a suggested regimen is provided.
12022179|NCT00426075|Device|Elastic stockings|
12022180|NCT00426049|Drug|Everolimus|
12022181|NCT00426036|Drug|Licarbazepine|
12022182|NCT00426023|Drug|Cyclosporine A 0,05% eye drop|Cyclosporine A 0.05% eye drops will be administered 2 times daily for six months in the first year of the study and in the second year of the study in a cross-over manner(from March to September)
12022183|NCT00426023|Drug|ketotifen fumarate 0.025% eye drops|ketotifen fumarate 0.025% eye drops 2 times daily for 6 months in the first year of the study (from March to September) and 6 months in the same period in the second year of the study in cross over manner.
12022184|NCT00426010|Drug|caffeine/placebo|caffeine or placebo, either overt or covert
12022185|NCT00425997|Drug|Valsartan/HCTZ|
12022186|NCT00425997|Drug|amlodipine|
12022187|NCT00425997|Drug|HCTZ|
12022188|NCT00425984|Procedure|Adult male circumcision|
12022189|NCT00425971|Drug|BMEC-1217B|
12022190|NCT00425945|Drug|Pine Bark Extract (Flavangenol®)|"Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
~Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day orally for 12 weeks."
12022191|NCT00425932|Biological|Rituximab|At Week 24 or any time up to Week 48 if the Patient DAS 28 > 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.
12022192|NCT00425919|Drug|PPM-204|
12022193|NCT00425906|Drug|nicotine|
12022194|NCT00425906|Other|Placebo|
12022195|NCT00425906|Procedure|Quality of life|
12022196|NCT00425893|Behavioral|hand hygiene|alcohol-based hand wash
12022197|NCT00425893|Other|health education|Proper nutrition, etc.
12022198|NCT00425893|Device|face masks|face masks
12022199|NCT00425867|Behavioral|PAR1 polymoprhisms and placental invasion|
12022200|NCT00425854|Drug|BIBW 2992|high dose once daily
12022201|NCT00425841|Drug|gemcitabine hydrochloride|
12022202|NCT00425841|Drug|oxaliplatin|
12022203|NCT00425841|Procedure|adjuvant therapy|
12022204|NCT00425841|Procedure|neoadjuvant therapy|
12022205|NCT00425841|Radiation|hypofractionated radiation therapy|
12022206|NCT00425841|Radiation|stereotactic radiosurgery|
12022207|NCT00425815|Drug|Org 24448|Org 24448 is a moderate-potency selective AMPA positive modulator that enhances the glutamate system in the brain.
12022208|NCT00425815|Other|Placebo|Placebo comparison
12022209|NCT00425802|Biological|anti-thymocyte globulin|
12022210|NCT00425802|Biological|filgrastim|
12022211|NCT00425802|Biological|graft-versus-tumor induction therapy|
12022212|NCT00425802|Biological|rituximab|
12022213|NCT00425802|Drug|cyclophosphamide|
12022214|NCT00425802|Drug|cyclosporine|
12022215|NCT00425802|Drug|fludarabine phosphate|
12022217|NCT00425802|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
12022218|NCT00425802|Radiation|total-body irradiation|
12022219|NCT00425789|Procedure|Treatment with Hyperbaric oxygen|
12022220|NCT00425776|Device|acupuncture|
12022221|NCT00425776|Device|Sham acupuncture|
12022222|NCT00425763|Drug|AQAS|AQAS dosed by body weight, on days 0, 1, 2
12022223|NCT00425750|Drug|bortezomib|1.6 mg/m2 through a vein on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
12022224|NCT00425750|Drug|docetaxel|40 mg/m2 through a vein on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1.
12022225|NCT00425750|Other|laboratory biomarker analysis|Tissue and blood collection.
12022226|NCT00425750|Other|pharmacological study|Blood collection.
12022227|NCT00425737|Biological|Rotarix|
12022228|NCT00425724|Drug|Methylprednisolone pulses plus prednisone versus Cyclosporine A|The patients will be randomised to receive either MP pulses i.v. or cyclosporine A p.o. The MP pulses will consist of three doses of methylprednisolone 30 mg/kg i.v. given over a period of one week in hospital. On the intermediate days and for a month after the MP pulses, the patients will be given prednisone 30 mg/m2/day p.o., after which the prednisone medication will be gradually run down over 3 months. The patients randomised into the cyclosporine A group will receive an initial dose of 5 mg/kg/day, after which the dosage will be titrated to an optimal therapeutic level by monitoring the B-Cya concentration. The cyclosporine A treatment will be continued for 12 months.
12022229|NCT00425711|Drug|Acamprosate|Acamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks
12022230|NCT00425698|Drug|Recombinant erythropoietin alpha (rHuEPO alpha)|Erythropoietin alpha 3 x 40.000 IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation
12022231|NCT00425698|Drug|Placebo|Placebo 3x IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation
12022232|NCT00425672|Biological|ONTAK|Given IV
12022233|NCT00425672|Other|flow cytometry|Correlative studies
12022234|NCT00425672|Other|immunohistochemistry staining method|Correlative studies
12022235|NCT00425672|Other|enzyme-linked immunosorbent assay|Correlative studies
12022236|NCT00425672|Other|laboratory biomarker analysis|Correlative studies
12022237|NCT00425672|Genetic|protein expression analysis|Correlative studies
12022238|NCT00425659|Device|home sleep study|different in algorithm arrangement for diagnosing sleep apnea
12022239|NCT00425659|Device|home CPAP titration (Autoset)|continuous positive airway pressure device for treatment of sleep apnea
12022240|NCT00425659|Device|CPAP|usual practice
12022241|NCT00425646|Biological|bevacizumab|
12022242|NCT00425646|Drug|imatinib mesylate|
12022243|NCT00425633|Drug|Homeopathic Potassium Dichromate|5 pellets under tongue q12h until extubation
12022244|NCT00425620|Drug|SinuNase|Lavage
12022245|NCT00425607|Drug|Lonafarnib|Lonafarnib will be taken orally, twice per day, by all patients enrolled on this study. The drug is supplied to patients in capsule form, and for patients who are unable to swallow pills, the drug may be dissolved into solution. Every patient will start lonafarnib therapy at a dose of 115mg/kg. The study allows for patients to receive a dose escalation (up to 150mg/kg) if the drug is being well-tolerated. Every patient enrolled on this study will undergo two years of lonafarnib therapy.
12022246|NCT00425594|Drug|HalfLytely and Bisacodyl Tablets - Formulation 1|
12022247|NCT00425594|Drug|HalfLytely and Bisacodyl Tablets - Formulation 2|
12022248|NCT00425594|Drug|NuLYTELY|
12022249|NCT00425568|Drug|AndroGel (Transdermal Testosterone Gel)|
12022250|NCT00425555|Drug|Panobinostat|
12022251|NCT00425542|Other|Outpatient care (vs traditional inpatient care)|Patients randomized to the outpatient arm are discharged from the emergency department within 24 hours after randomization. Patients randomized to the inpatient arm are admitted to the hospital and are discharged based on the decision of the managing physician at the hospital.
12022252|NCT00425529|Device|Module AOX (attached to Sondalis ISO)|
12022253|NCT00425516|Drug|Taxotere|
12022254|NCT00425516|Drug|5-Fluorouracil|
12022255|NCT00425516|Drug|Epirubicin|
12022256|NCT00425516|Drug|Cyclophosphamide|
12022257|NCT00425503|Drug|PS-341 (bortezomib)|PS-341 is a dipeptidyl boronic acid inhibitor with high specificity for the proteasome developed by Millennium Pharmaceuticals Inc. to treat human malignancies. It is the first member of this class of anti-tumor agents to come to human trials. Patients will receive PS-341 (1.6mg/m2/dose) by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest. This schedule consists of one treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest period, radical prostatectomy will be performed.
12022258|NCT00425490|Drug|sitagliptin|
12022259|NCT00425477|Biological|sargramostim|
12022260|NCT00425477|Drug|bexarotene|
12022261|NCT00425477|Genetic|cytogenetic analysis|
12022262|NCT00425477|Genetic|fluorescence in situ hybridization|
12022263|NCT00425477|Other|flow cytometry|
12022264|NCT00425477|Other|laboratory biomarker analysis|
12022265|NCT00425477|Procedure|biopsy|
12022266|NCT00425464|Device|Standard Monofocal Intraocular Lens|"The control (active comparator) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a standard monofocal intraocular lens.
~Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis."
12022267|NCT00425464|Device|Synchrony® Dual Optic Intraocular Lens|"The Synchrony® Dual Optic Intraocular Lens (experimantal) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a Synchrony® Dual Optic Intraocular Lens.
~Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis."
12022268|NCT00425451|Drug|PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip|
12022269|NCT00425438|Drug|Mycophenolate Mofetil|0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48
12022387|NCT00424645|Drug|Voraxaze (Glucarpidase)|50 units/kg IV within 12 hours of study eligibility being confirmed.
12022270|NCT00425438|Drug|Corticosteroids|0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48
12022271|NCT00425438|Drug|Azathioprine|100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48
12022272|NCT00425438|Drug|Cyclophosphamide|0.75 g/m^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2 to maintain a minimum WBC count of ≥ 2500 per mm^3 from Weeks 5 through 24
12022273|NCT00425425|Biological|cetuximab|
12022274|NCT00425425|Drug|fluorouracil|
12022275|NCT00425425|Drug|oxaliplatin|
12022276|NCT00425425|Procedure|conventional surgery|
12022277|NCT00425425|Procedure|neoadjuvant therapy|
12022278|NCT00425425|Radiation|radiation therapy|
12022279|NCT00425399|Procedure|Shiatsu|Shiatsu treatment provided in 40-minute sessions, twice a week for 4 weeks
12022280|NCT00425386|Drug|erlotinib hydrochloride|"Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
~150 mg/day, continuous daily"
12022281|NCT00425386|Drug|sunitinib malate|Will be administered at 50 mg daily, 4 weeks on, 2 weeks off
12022282|NCT00425386|Procedure|biopsy|Paraffin block (or unstained slides) of the primary tumor and/or metastatic lesions (as available) and a plasma sample for future correlative studies will be collected. A paraffin block (or at least 10 unstained slides, each of 10 micromillimeter thickness) from the original paraffin-embedded biopsy material taken at the diagnosis will be stored at 4 degrees Celsius.
12022283|NCT00425373|Drug|Valsartan + amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
12022284|NCT00425373|Drug|Valsartan + amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
12022285|NCT00425373|Drug|Valsartan + amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
12022286|NCT00425373|Drug|Valsartan + amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
12022287|NCT00425373|Drug|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
12022288|NCT00425373|Drug|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
12022289|NCT00425373|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
12022290|NCT00425373|Drug|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
12022291|NCT00425373|Drug|Placebo|4 tablet and 2 capsule placebos taken once daily
12022292|NCT00425360|Biological|sargramostim|
12022293|NCT00425360|Biological|telomerase peptide vaccine GV1001|
12022294|NCT00425360|Drug|capecitabine|
12022295|NCT00425360|Drug|gemcitabine hydrochloride|
12022296|NCT00425347|Drug|HuLuc63|Not applicable for HuLuc63.
12022297|NCT00425334|Drug|Hemospan (MP4OX)|250 mL or 500 mL Hemospan (MP4OX)
12022298|NCT00425334|Drug|Ringer's lactate|250 mL or 500 mL Ringer's lactate USP
12022299|NCT00425321|Drug|RWJ-445380 100 mg|RWJ-445380 100 mg once daily for up to 12 weeks
12022300|NCT00425321|Drug|RWJ-445380 200 mg|RWJ-445380 200 mg once daily for up to 12 weeks
12022301|NCT00425321|Drug|RWJ-445380 300 mg|RWJ-445380 300 mg once daily for up to 12 weeks
12022302|NCT00425321|Drug|Placebo|Placebo once daily for up to 12 weeks
12022303|NCT00425308|Drug|Everolimus + Cyclosporine|
12022304|NCT00425308|Drug|Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)|
12022305|NCT00425308|Drug|Steroids|
12022306|NCT00425295|Behavioral|Human Simulation Training|Fellows will undergo Human Simulation Training (HST) composed of one 1 hour session of high-fidelity simulation of crisis scenarios requiring management of critical care skills, including triage, Advanced Cardiac Life Support (ACLS), team management, and difficult airway management.
12022307|NCT00425282|Drug|RWJ-333369|
12022308|NCT00425269|Behavioral|lifestyle intervention (diet and physical activity)|The intervention will include a combination of individual counselling group sessions. The intervention groups will be divided into subgroups of 10-12 subjects. Each group will have 10 group sessions on diet/lifestyle in the 6 months the intervention period lasts, and will additionally have the possibility to join a culturally adapted exercise program of low intensity twice a week.
12022309|NCT00425256|Drug|Bremelanotide|
12022310|NCT00425243|Drug|zolpidem-MR (SL800750)|
12022311|NCT00425230|Drug|Duloxetine|
12022312|NCT00425217|Drug|Rituximab|
12022313|NCT00425204|Drug|Panitumumab (ABX-EGF)|Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks.
12022314|NCT00425191|Drug|Docetaxel and Gemcitabine|Docetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8
12022315|NCT00425191|Drug|Docetaxel and Gemcitabine|Docetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15.
12022316|NCT00425191|Drug|Gemcitabine cisplatin followed by docetaxel|Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2
12022317|NCT00425178|Drug|FGF-1|
12022318|NCT00425165|Drug|denufosol tetrasodium (INS37217) Inhalation Solution|Denufosol 60 mg is administered as an inhalation solution one time during the study.
12022319|NCT00425152|Drug|fluorouracil|
12022320|NCT00425152|Drug|leucovorin calcium|
12022321|NCT00425152|Drug|levamisole hydrochloride|
12022322|NCT00425139|Behavioral|Re-Mission|
12022323|NCT00425126|Drug|Epoetin Alfa|
12022324|NCT00425113|Drug|Metronidazole|
12022325|NCT00425113|Procedure|Blood Draw|
12022326|NCT00425113|Procedure|CT Scan|
12022327|NCT00425113|Procedure|PET Scan|
12022388|NCT00424645|Drug|Placebo|Administered by IV within 12 hours of study eligibility being confirmed.
12022328|NCT00425100|Drug|fesoterodine fumarate|12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.
12022329|NCT00425074|Drug|slow release acetyl salicylic acid|150 mg in capsules via oral, during 14 days.
12022330|NCT00425074|Drug|ASA|normal release acetylsalicylic acid
12022331|NCT00425074|Drug|SR-ASA|slow release acetylsalicylic acid 150 mg
12022332|NCT00425061|Biological|IMA-638|SC Injection, 12 weeks
12022333|NCT00425061|Biological|IMA-638|SC Injection, 12 weeks
12022334|NCT00425061|Other|placebo|placebo
12022335|NCT00425048|Procedure|wearing gloves|
12022336|NCT00425035|Drug|Panitumumab (ABX-EGF)|
12022337|NCT00425022|Procedure|thoracoscopy|
12022338|NCT00425009|Drug|Berberine|
12022339|NCT00425009|Drug|Metformin|
12022340|NCT00424983|Drug|Zoledronic acid|
12022341|NCT00424970|Drug|acetazolamide|
12022342|NCT00424944|Biological|GMZ2 (malaria vaccine)|100 micrograms of GMZ2 in each vaccination
12022343|NCT00424944|Biological|GMZ2 malaria vaccine|100 micrograms of GMZ2
12022344|NCT00424944|Biological|Verorab vaccine|Anti-rabies vaccine
12022345|NCT00424931|Drug|JNJ-17216498|50mg one time
12022346|NCT00424931|Drug|JNJ-17216498|10mg one time
12022347|NCT00424931|Drug|Modafinil|200 mg X 2
12022348|NCT00424918|Behavioral|Physical Activity, reduced sedentary behavior|
12022349|NCT00424905|Drug|Bacillus clausii|2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.
12022350|NCT00424892|Drug|Desvenlafaxine Sustained Release|
12022351|NCT00424866|Drug|FGF-1|"Doses of FGF-1: 3 ug/kg; 10 ug/kg; 30 ug/kg
~Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg"
12022352|NCT00424866|Drug|Placebo|Vehicle: 0 µg/kg
12022353|NCT00424853|Drug|Docetaxel and cisplatin followed by gemcitabine|docetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles
12022354|NCT00424853|Drug|docetaxel and cisplatin followed by gemcitabine|docetaxel 25 mg/m2 day 1,8,15 + cisplatin 25 mg/m2 days1,8,15 repeated every 28 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles.
12022355|NCT00424840|Drug|Bortezomib 1.3 mg/m2|"Level I (every 21 day cycle, D8), 1.3 mg/m2:
~Day 1: bevacizumab 15 mg/kg ,carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.3 mg/m2 Day 8 : bortezomib 1.3 mg/m2
~Level II (every 21 day cycle):
~Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.6 mg/m2 Day 8 : bortezomib 1.6 mg/m2
~Level III(every 21 day cycle):
~Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.8 mg/m2 Day 8 : bortezomib 1.8 mg/m2"
12022356|NCT00424840|Drug|Bortezomib 1.6 mg/m2|Level II (every 21 day cycle, D8), 1.6 mg/m2
12022357|NCT00424840|Drug|Bortezomib 1.8 mg/m2|Level III (every 21 day cycle, D8) 1.8 mg/m2
12022358|NCT00424840|Drug|Carboplatin AUC 6|Carboplatin AUC6
12022359|NCT00424840|Drug|Bevacizumab|Bevacizumab 15 mg/kg
12022360|NCT00424840|Drug|Taxotere|Taxotere 70 + G-CSF
12022361|NCT00424827|Drug|Gemcitabine/Fluorouracil with External Beam Radiation|This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
12022362|NCT00424814|Drug|Kaletra (lopinavir/ritonavir)|(200/50 mg x2)x 2/d= 2 pills twice daily
12022363|NCT00424814|Drug|Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)|Kaletra (lopinavir/ritonavir): (200/50 mg x2)x 2/d= 2 pills twice daily Combivir (zidovudine/lamivudine): (300/150mg) x 2/d=1 pill twice daily
12022364|NCT00424801|Drug|Lercanidipine|Individual titration, max. dose 20 mg OD for 8 months
12022365|NCT00424801|Drug|Valsartan|Individual titration, max. dose 160 mg OD for 8 months
12022366|NCT00424801|Drug|Nicorandil|Individual titration, max. dose 20 mg BD for 8 months
12022367|NCT00424801|Drug|Doxazosin|Individual titration, max. dose 4 mg OD for 8 months
12022368|NCT00424801|Drug|Moxonidin|Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 0,2 mg OD for 8 months
12022369|NCT00424801|Drug|Pindolol|Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 10 mg OD for 8 months
12022370|NCT00424801|Drug|Amiloride, hydrochlorothiazide|Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 1 tbl. OD for 8 months
12022371|NCT00424788|Procedure|Plasma exchange|
12022372|NCT00424788|Drug|natalizumab treatment|
12022373|NCT00424775|Drug|MK0683, vorinostat|vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
12022374|NCT00424762|Drug|rosiglitazone|6 months of treatment of blinded study drug
12022375|NCT00424762|Drug|placebo|blinded treatment with matching placebo
12022376|NCT00424749|Drug|Rituximab|Patients received 4 weekly doses of rituximab 375 mg/m^2.
12022377|NCT00424749|Drug|Prednisone|Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months
12022378|NCT00424736|Procedure|whole body CT scan|
12022379|NCT00424723|Drug|Pemetrexed|Given intravenously over 10 minutes every 21 days (21 days equals one cycle). Subjects will continue to receive pemetrexed as long as their disease does not worsen and they do not experience any serious side effects.
12022380|NCT00424710|Drug|ranibizumab intravitreal injection|liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
12022381|NCT00424697|Drug|placebo|
12022382|NCT00424697|Drug|lorazepam|
12022383|NCT00424697|Drug|GW876008|
12022384|NCT00424684|Procedure|collection of blood sample|
12022385|NCT00424671|Drug|Licarbazepine|
12022386|NCT00424658|Procedure|SAHS diagnosis|
12022389|NCT00424632|Drug|PF-03814735|1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity.
12022390|NCT00424619|Drug|Vitamin D2|50 000 IU vitamin D2, one time bolus dose
12022391|NCT00424619|Drug|Vitamin D2|100 000 IU vitamin D2, one time bolus dose
12022392|NCT00424619|Drug|Placebo|Placebo, 1 time bolus dose
12022393|NCT00424606|Drug|Docetaxel|Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
12022394|NCT00424606|Drug|Epirubicin|Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
12022395|NCT00424606|Drug|Epirubicin|Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
12022396|NCT00424606|Drug|Docetaxel|Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
12022397|NCT00424593|Drug|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
12022398|NCT00424593|Drug|Placebo|every day (QD), by mouth (PO), 13 weeks
12022399|NCT00424580|Drug|Montelukast (10mg) and Desloratadine (5mg)|
12022400|NCT00424567|Procedure|Fracture surgery|
12022401|NCT00424567|Drug|Cultured Bone Marrow Tissue|
12022402|NCT00424554|Drug|temozolomide|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
~As standard of care, it could also be given at the same dose for up to 28 days after surgery, per investigator discretion."
12022403|NCT00424541|Drug|SPP100 (aliskiren)|
12022404|NCT00424528|Drug|Arformoterol Tartrate Inhalation Solution|Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.
12022405|NCT00424528|Drug|Tiotropium|Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.
12022406|NCT00424528|Drug|Arformoterol and Tiotropium|Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.
12022407|NCT00424528|Drug|Placebo|Placebo inhalation solution and placebo inhalation powder
12022408|NCT00424515|Drug|Imatinib|Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.
12022409|NCT00424502|Drug|rituximab [MabThera/Rituxan]|1g iv on days 1 and 15
12022410|NCT00424502|Drug|Methotrexate|10-25mg po/week
12022411|NCT00424489|Biological|Hematopoietic Stem Cell Transplantation|Autologous Hematopoietic Stem Cell Transplantation
12022412|NCT00424489|Drug|Cyclophosphamide|
12022413|NCT00424489|Drug|ATG (rabbit)|
12022414|NCT00424489|Drug|Mesna|
12022415|NCT00424489|Drug|Methylprednisolone|
12022416|NCT00424489|Drug|G-CSF|
12022417|NCT00424476|Drug|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
12022418|NCT00424476|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
12022419|NCT00424476|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
12022420|NCT00424463|Drug|MCI-186|Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.
12022421|NCT00424463|Drug|Placebo of MCI-186|Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.
12022422|NCT00424450|Procedure|lower limb artery bypass surgery|bypass of severe atherosclerotic vascular lesion
12022423|NCT00424450|Procedure|percutaneous angioplasty (PTA)|PTA of severe atherosclerotic lesion
12022424|NCT00424437|Drug|Inhaled human insulin|
12022425|NCT00424424|Drug|MK0719|
12022426|NCT00424411|Drug|Inhaled human insulin (EXUBERA™)|
12022427|NCT00424398|Drug|Bepreve|sterile ophthalmic solution
12022428|NCT00424398|Drug|Placebo|sterile ophthalmic solution
12022429|NCT00424398|Drug|Bepotastine Besilate|sterile ophthalmic solution
12022430|NCT00424385|Drug|Gleevec + Sorafenib|400 mg Sorafenib every day (QD) 300mg Gleevec QD
12022431|NCT00424372|Drug|pregabalin|Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
12022432|NCT00424346|Drug|Canakinumab|
12022433|NCT00424346|Drug|Placebo|
12022434|NCT00424333|Drug|Inhaled human insulin|
12022435|NCT00424320|Drug|Sodium bicarbonate|
12022436|NCT00424307|Device|HiResolution Bionic Ear System|
12022437|NCT00424294|Drug|CP-195,543|CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.
12022438|NCT00424294|Drug|celecoxib|Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.
12022439|NCT00424294|Drug|Methotrexate|Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.
12022440|NCT00424281|Drug|Arixtra (fondaparinux), 2.5 mg/day-what is bioavailability|
12022441|NCT00424268|Drug|Roflumilast|500 µg, once daily, oral administration in the morning
12022442|NCT00424268|Drug|Placebo|once daily
12022443|NCT00424255|Drug|Lapatinib|Dual ErbB1/2 inhibitor
12022444|NCT00424255|Radiation|Chemoradiation|Radiation plus platinum based chemotherapy
12022445|NCT00424255|Other|Placebo|Placebo
12022446|NCT00424242|Drug|Pemetrexed|Orally beginning at 500 mg/m2 every 3 weeks until disease progression
12022447|NCT00424229|Drug|LENALIDOMIDE|
12022448|NCT00424216|Procedure|DC Polarization|
12022449|NCT00424203|Drug|AC regimen|
12022450|NCT00424203|Drug|cyclophosphamide|
12022451|NCT00424203|Drug|doxorubicin hydrochloride|
12022452|NCT00424203|Procedure|adjuvant therapy|
12022453|NCT00424203|Procedure|cognitive assessment|
12022454|NCT00424203|Procedure|management of therapy complications|
12022455|NCT00424203|Procedure|psychosocial assessment and care|
12022456|NCT00424203|Procedure|quality-of-life assessment|
12022457|NCT00424190|Drug|IV Vancomycin plus IV Aztreonam|vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
12022458|NCT00424190|Drug|Ceftaroline|600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
12022459|NCT00424177|Drug|eltrombopag|experimental
12022460|NCT00424164|Drug|lapatinib ditosylate|
12022461|NCT00424164|Drug|tamoxifen citrate|
12022462|NCT00424164|Other|pharmacological study|
12022463|NCT00424151|Drug|Rituximab|
12022464|NCT00424138|Radiation|FDG|
12022465|NCT00424125|Behavioral|Enhanced Pharmacy Care|"Participants randomized to Enhanced Pharmacy Care will have their prescriptions electronically transmitted or faxed to one of the five participating pharmacies.
~Pharmacists will then provide real-time, targeted education around the purpose and use of the new and refilled ICS medications to study participants and their families at each point of contact, including rationale for their use, device teaching, dosage review, and importance of compliance. Families randomized to enhanced care will also be contacted monthly by phone and mail with reminders to fill their controller medications prescriptions and to seek ongoing longitudinal asthma care with their primary care providers."
12022466|NCT00424125|Behavioral|Control|Usual care.
12022467|NCT00424099|Drug|Methylphenidate|5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days.
12022468|NCT00424099|Behavioral|Nursing Telephone Intervention|Call from study nurse 3 times weekly to ask about side effects and other symptoms.
12022469|NCT00424099|Drug|Placebo|One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.
12022470|NCT00424099|Behavioral|Non NTI|Non NTI are calls from research staff 3 times weekly.
12022471|NCT00424086|Biological|Inactivated seasonal influenza vaccine (split virus, vero cell derived)|
12022472|NCT00424086|Biological|Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine]|
12022473|NCT00424060|Drug|sagopilone|
12022474|NCT00424060|Genetic|fluorescence in situ hybridization|
12022475|NCT00424060|Genetic|gene expression analysis|
12022476|NCT00424060|Other|immunohistochemistry staining method|
12022477|NCT00424060|Other|laboratory biomarker analysis|
12022478|NCT00424060|Other|pharmacological study|
12022479|NCT00424047|Drug|CC-5013 plus dexamethasone|25 mg daily for 21 days every 28 days.
12022480|NCT00424047|Drug|Dexamethasone plus Placebo|Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
12022481|NCT00424034|Drug|GSK1325760A|
12022482|NCT00424021|Drug|ambrisentan|1, 2.5, 5, and 10 mg ambrisentan given orally once daily
12022483|NCT00424008|Drug|Mometasone furoate/formoterol (MF/F) MDI|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
12022484|NCT00424008|Drug|Fluticasone propionate/salmeterol (F/SC) DPI|Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.
12022485|NCT00423995|Drug|Loratadine/montelukast combination|
12022486|NCT00423982|Drug|Rifampin-combination therapy|Rifampin 300 mg x 3 po and cloxacillin 2 g x 4 iv for two weeks. Then rifampin 300 mg x 3 po and cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, rifampin 300 mg x 3 po and vancomycin 1 g x 2 iv for 6 weeks.
12022487|NCT00423982|Drug|Monotherapy|Cloxacillin 2 g x 4 iv for two weeks, then cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, vancomycin 1 g x 2 iv for 6 weeks.
12022488|NCT00423969|Drug|Galantamine|
12022489|NCT00423969|Drug|Escitalopram|
12022490|NCT00423956|Procedure|Repairing Induced tooth root resorption by ultrasound|Repairing Induced tooth root resorption by ultrasound
12022491|NCT00423943|Drug|modafinil|200 milligrams daily dose
12022492|NCT00423943|Drug|Placebos|capsule containing placebo
12022493|NCT00423930|Biological|bevacizumab|
12022494|NCT00423930|Drug|cisplatin|
12022495|NCT00423930|Procedure|conventional surgery|
12022496|NCT00423930|Radiation|intensity-modulated radiation therapy|
12022497|NCT00423917|Biological|bevacizumab|
12022498|NCT00423917|Drug|fulvestrant|
12022499|NCT00423904|Behavioral|Brief intervention|
12022500|NCT00423891|Drug|Entecavir|Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response
12022501|NCT00423878|Drug|Risperidone|Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
12022502|NCT00423878|Drug|Olanzapine|Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
12022503|NCT00423878|Drug|Quetiapine|Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
12022504|NCT00423878|Drug|Aripiprazole|Switching medication to aripiprazole for schizophrenia for up to 6 months in study
12022505|NCT00423865|Drug|cisplatin|cisplatin (20 mg/m2 intravenously on Days 1, 8, and 15)
12022506|NCT00423865|Drug|everolimus|escalating doses of daily RAD001 tablets (per oral or via percutaneous gastrostomy tube, Days 1 -21 of a 28-Day Cycle)
12022507|NCT00423865|Genetic|gene expression analysis|Each biopsy specimen will be formalin-fixed and paraffin-embedded for IHC, and analysis of p53 and p21 will follow methods previous reported by our group. The avidin-biotin immunoperoxidase technique will be employed.
12022562|NCT00423592|Drug|ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
12022564|NCT00423579|Drug|simvastatin 40 mg|1 tablet containing 40 mg of simvastatin per day for 6 weeks
12022508|NCT00423865|Other|immunohistochemistry staining method|After the phase 2 recommended dose is established in the phase I portion of the study (Part A), we plan to enroll an additional 6 patients for pharmacodynamic studies (Part B). Entry into Part B requires the patient have tumor tissue which is easily accessible for research biopsy. The patients will be asked to provide written informed consent for the research biopsies. Patients also will be asked to provide written informed consent to allow the use of their tissue for future research studies. The research biopsies are not mandatory for any patient. Patients who do not consent to the research biopsies or who withdraw consent for the research biopsies may still receive RAD001 + cisplatin in the study
12022509|NCT00423865|Other|laboratory biomarker analysis|Laboratory data (complete blood count, comprehensive metabolic panel including magnesium) regarding adverse events will be collected on each cisplatin treatment day. Additional adverse event data will be collected at regularly scheduled clinic visits at which history and physical are performed by the investigator (Cycle 1 - Days 1, 8, 15, and 21. Cycle 2 - Days 1 and 15. Cycle 3 and beyond - Day 1)
12022510|NCT00423865|Other|pharmacological study|For patients in Part A, research bloods for pharmacokinetics are drawn on Day 1 and Day 8.
12022511|NCT00423865|Procedure|biopsy|"Pre-treatment Research Biopsy: Within 14 days prior to treatment, research biopsy (of primary tumor, metastatic deposit, or involved lymph node) will be performed. Baseline labs should be drawn within 14 days of the research biopsy. The biopsy sample will be formalin-fixed and paraffin-embedded for immunohistochemistry. Post-treatment Research Biopsy: Research biopsy (of primary tumor, metastatic deposit, or involved lymph node) will be requested again for Day 15 of Cycle 1, prior to administration of RAD001 and cisplatin on that day."
12022512|NCT00423852|Biological|filgrastim|
12022513|NCT00423852|Drug|carboplatin|
12022514|NCT00423852|Drug|ifosfamide|
12022515|NCT00423852|Drug|paclitaxel|
12022516|NCT00423852|Procedure|autologous hematopoietic stem cell transplantation|
12022517|NCT00423852|Procedure|peripheral blood stem cell transplantation|
12022518|NCT00423839|Biological|MVA85A (Tuberculosis vaccine)|
12022519|NCT00423826|Drug|Busulfan|3 mg/kg intravenously over 3 hours
12022520|NCT00423826|Drug|Cytarabine|Patients with previous history of CNS involvement will receive pre-transplant intrathecal Cytarabine (Ara-C) (30 mg/M2) therapy.
12022521|NCT00423826|Drug|Fludarabine phosphate|25 mg/M2/day IV
12022522|NCT00423826|Drug|mycophenolate mofetil|Orally at the dose of 1 gm every 8 hours.
12022523|NCT00423826|Drug|tacrolimus|0.015 mg/kg IV every 12 hours by continuous infusion.
12022524|NCT00423826|Procedure|allogeneic hematopoietic stem cell transplantation|10 days post drug intervention
12022525|NCT00423826|Procedure|umbilical cord blood transplantation|10 days post drug intervention
12022526|NCT00423826|Radiation|total-body irradiation|10 days post drug intervention
12022527|NCT00423813|Drug|placebo|Oral Solution
12022528|NCT00423813|Drug|Xyrem®|two doses
12022529|NCT00423800|Drug|Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)|"Powder for Solution in Redipen® (pegylated interferon alfa-2b) (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
~200 mg ribavirin capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks"
12022530|NCT00423787|Biological|Ragweed MATA MPL|"4 injections of increasing dose strength:
~300 SU/0.5 ml
~700 SU/0.5 ml
~2000 SU/0.5 ml
~6000 SU/0.5 ml"
12022531|NCT00423774|Behavioral|Problem-Solving Education|
12022532|NCT00423761|Drug|midazolam|
12022533|NCT00423761|Drug|GW876008|
12022534|NCT00423748|Drug|ambrisentan|
12022535|NCT00423735|Drug|Dasatinib|Given PO
12022536|NCT00423735|Other|Pharmacological Study|Correlative studies
12022537|NCT00423722|Drug|Saline|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
12022538|NCT00423722|Drug|Saline|100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
12022539|NCT00423709|Procedure|Allogeneic Blood Stem Cell Transplantation|
12022540|NCT00423709|Drug|Fludarabine|
12022541|NCT00423709|Drug|Melphalan|
12022542|NCT00423696|Biological|bevacizumab|
12022543|NCT00423696|Drug|capecitabine|
12022544|NCT00423696|Drug|fluorouracil|
12022545|NCT00423696|Drug|irinotecan hydrochloride|
12022546|NCT00423696|Drug|leucovorin calcium|
12022547|NCT00423696|Procedure|quality-of-life assessment|
12022548|NCT00423683|Drug|Arixtra alone|Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
12022549|NCT00423683|Device|Arixtra + filter|Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
12022550|NCT00423670|Drug|boceprevir (SCH 503034)|200 mg capsules taken as 800 mg orally three times daily (TID)
12022551|NCT00423670|Drug|peginterferon-alfa 2b (PegIntron)|1.5 μg/kg subcutaneously (SC) once weekly (QW)
12022552|NCT00423670|Drug|ribavirin|200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily
12022553|NCT00423670|Drug|ribavirin (low-dose)|200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily
12022554|NCT00423657|Drug|ceftaroline|600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
12022555|NCT00423657|Drug|vancomycin plus aztreonam|vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
12022556|NCT00423657|Drug|Placebo|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
12022557|NCT00423644|Drug|Darinaparson|420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months
12022558|NCT00423631|Behavioral|Standard care and web|A static web site containing cognitive and behavioral self management instructions.
12022559|NCT00423631|Behavioral|Standard Care|Standard care delivered by the primary care provider.
12022560|NCT00423618|Radiation|radiotherapy|radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities
12022561|NCT00423605|Drug|Xyrem®|flexible dosing
12022563|NCT00423579|Drug|Ezetimibe/Simvastatin 10/20 mg|1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks
12022565|NCT00423566|Biological|MVA85A (Tuberculosis vaccine)|
12022566|NCT00423540|Drug|Intravenous Infusion of Magnesium Sulfate|See Detailed Description.
12022567|NCT00423527|Drug|levetiracetam|Levetiracetam tablets 500 mg, total daily dose 3000 mg
12022568|NCT00423514|Biological|filgrastim|
12022569|NCT00423514|Drug|clofarabine|
12022570|NCT00423514|Drug|melphalan|
12022571|NCT00423514|Drug|mycophenolate mofetil|
12022572|NCT00423514|Drug|tacrolimus|
12022573|NCT00423514|Drug|thiotepa|
12022574|NCT00423514|Procedure|allogeneic bone marrow transplantation|
12022575|NCT00423514|Procedure|allogeneic hematopoietic stem cell transplantation|
12022576|NCT00423514|Procedure|peripheral blood stem cell transplantation|
12022577|NCT00423501|Drug|Placebo|sc weekly
12022578|NCT00423501|Drug|taspoglutide|20mg sc weekly
12022579|NCT00423501|Drug|taspoglutide|10mg sc every 2 weeks
12022580|NCT00423501|Drug|taspoglutide|5mg sc weekly
12022581|NCT00423501|Drug|taspoglutide|10mg sc weekly
12022582|NCT00423501|Drug|taspoglutide|20mg sc every 2 weeks
12022583|NCT00423488|Drug|Ezetimibe 10 mg|1 x 10-mg tablet, provided as blinded study treatment
12022584|NCT00423488|Drug|Simvastatin 20 mg|1 x 20-mg tablet, provided as open-label study treatment
12022585|NCT00423488|Drug|Ezetimibe Placebo|1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment
12022586|NCT00423488|Drug|Simvastatin 20 mg|1 x 20-mg tablet, provided as blinded study treatment
12022587|NCT00423488|Drug|Simvastatin Placebo|1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment
12022588|NCT00423475|Drug|goserelin acetate|
12022589|NCT00423475|Procedure|adjuvant therapy|
12022590|NCT00423475|Radiation|radiation therapy|
12022591|NCT00423462|Behavioral|Brief dynamic psychotherapy|
12022592|NCT00423449|Drug|vorinostat|Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days
12022593|NCT00423449|Drug|Gemcitabine|Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle
12022594|NCT00423449|Drug|Platinum-based agent|Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.
12022595|NCT00423436|Behavioral|Questionnaire|Questionnaires taking about 30-45 minutes to complete.
12022596|NCT00423436|Behavioral|Interactive Voice Response Telephone System|IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes.
12022597|NCT00423436|Behavioral|IVR Plus Triage|"IVR system will triage, or sort, the symptom data by symptom severity, notifying health care professionals when a symptom is greater than the set threshold limit."
12022598|NCT00423410|Drug|EPC2407 (crinobulin)|IV infusion 1 to 4 hours
12022599|NCT00423397|Biological|PEG-interferon alfa-2a|
12022600|NCT00423397|Drug|gefitinib|
12022601|NCT00423384|Drug|Placebo|Placebo
12022602|NCT00423384|Drug|Ibandronate|I.v.
12022603|NCT00423371|Device|sodium hyaluronate|EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.
12022604|NCT00423371|Device|placebo|Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.
12022605|NCT00423358|Dietary Supplement|Vitamin D|Ergocalciferol 50,000 IU loading dose then twice monthly for one year
12022606|NCT00423358|Dietary Supplement|placebo|matching placebo
12022607|NCT00423332|Drug|Cediranib|45 mg oral tablet
12022608|NCT00423332|Drug|Cediranib Placebo|oral tablet
12022609|NCT00423319|Drug|Enoxaparin|Subcutaneous, 40 mg, once daily, 5 weeks
12022610|NCT00423319|Drug|Apixaban|Oral tablets, 2.5 mg, twice daily, 5weeks
12022611|NCT00423319|Drug|Enoxaparin-matching placebo|Administered as injection
12022612|NCT00423319|Drug|Apixaban-matching placebo|Administered as oral tablets
12022613|NCT00423306|Drug|Darinaparsin|420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest, for up to 6 months
12022614|NCT00423293|Drug|fluorouracil|1000 mg/m^2/day 96-hour continous infusion (M-F) starting on day 1 and again on day 29 of radiation therapy.
12022615|NCT00423293|Drug|mitomycin C|10 mg/m^2 intravenous therapy on day 1 and day 29 of radiation therapy.
12022616|NCT00423293|Radiation|Intensity-modulated radiation therapy|"Prescription dose depends on tumor staging.
~T2N0: The primary tumor PTV (planning target volume) (PTVA) receives 50.4 Gy in 28 fractions (fx) at 1.8 Gy/fx. The nodal PTVs receive 42 Gy in 28 fx at 1.5 Gy/fx. PTVA receive 50.4 Gy in 28 fractions at 1.8 Gy/fx. PTV42 receive 42 Gy in 28 fx at 1.5 Gy/fx and will include all nodal regions.
~T3N0 or T4N0: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. The nodal PTVs will receive 45 Gy in 30 fx at 1.5 Gy/fx. PTVA will receive 54 Gy in 30 fx at 1.80 Gy/fx. PTV45 will receive 45 Gy in 30 fx electively at 1.5 Gy/fx and will include all nodal regions.
~For N+ disease: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. For involved nodes ≤ 3 cm in maximum dimension, the involved nodal PTV will receive 50.4 Gy in 30 fx at 1.68 Gy/fx. For involved nodes > 3 cm in maximum dimension, the involved nodal PTV will receive 54 Gy in 30 fx at 1.80 Gy/fx."
12022617|NCT00423280|Drug|6R-BH4|6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
12022618|NCT00423267|Drug|Posaconazole|Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months
12022619|NCT00423267|Drug|Fluconazole|Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months
12022620|NCT00423254|Biological|PSMA/PRAME|Low dose
12022621|NCT00423254|Biological|PSMA/PRAME|high dose
12022622|NCT00423241|Device|SEMPERFLO Pain Management System|continuous infusion of 0.5% bupivacaine at 2mL per hour
12022623|NCT00423241|Device|ON-Q PainBuster Post-Op Pain Relief System|continuous infusion of 0.5% bupivacaine at 2mL per hour
12022676|NCT00422799|Drug|Bortezomib|Once weekly for 3 weeks
12022677|NCT00422799|Drug|Rituximab|Intravenously once a week for the first and fourth weeks of a cycle
12022624|NCT00423228|Drug|ZT-1|Patients in the ZT-1 treatment group will receive ZT 1-1 mg capsules administered p.o. daily during the first month of treatment, followed by ZT-1 implants (9 mg) administered s.c. during the second month of treatment, followed by ZT-1 implants (12 mg) administered s.c. every 4 weeks during months 3 to 6 of treatment. Patients in the ZT-1 treatment group will receive dummy donepezil capsules during months 2 to 6 of the treatment period.
12022625|NCT00423228|Drug|Donepezil|Patients in the donepezil treatment group will receive donepezil 5 mg capsules administered p.o. during the first month of treatment, followed by donepezil 10 mg/day during months 2 to 6 of the treatment period. Patients in the donepezil treatment group will also receive s.c. injections of dummy ZT 1 implants every 4 weeks during months 2 to 6 of the treatment period.
12022626|NCT00423215|Drug|Insulin glargine (LANTUS)|"The patients will receive Lantus administered by subcutaneous injection, once daily at any time but at the same time each day.
~Treatment duration: 4 months."
12022627|NCT00423202|Drug|ambrisentan|
12022628|NCT00423189|Drug|Ranibizumab (Lucentis)|as needed, one intravitreal injection of 0.50mg ranibizumab
12022629|NCT00423189|Drug|0.5mg ranibizumab|as needed, one intravitreal injection of 0.50mg ranibizumab
12022630|NCT00423176|Drug|MFNS and antibiotic|MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
12022631|NCT00423176|Drug|Matching Placebo nasal spray plus antibiotic|Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
12022632|NCT00423163|Drug|micafungin|
12022633|NCT00423163|Drug|voriconazole|
12022634|NCT00423150|Drug|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.
12022635|NCT00423137|Drug|BIBW 2948 BS|
12022636|NCT00423137|Drug|Placebo|
12022637|NCT00423124|Genetic|HSV-TK|Infusion of genetically modified lymphocytes (1x10^6-1x10^7 c/kg): first at +21-+49 days after HSCT; in absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.
12022638|NCT00423098|Drug|Mycophenolate sodium|Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
12022639|NCT00423098|Drug|Prednisone|Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
12022640|NCT00423098|Drug|Methylprednisolone|All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
12022641|NCT00423085|Drug|Rivastigmine transdermal patch|"Rivastigmine transdermal patch was provided in the following sizes and doses:
~2.5 cm^2 (4.5 mg), 5 cm^2 (9 mg), 7.5 cm^2 (13.5 mg), and 10 cm^2 (18 mg). The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day."
12022642|NCT00423085|Drug|Placebo|Placebo transdermal patch was provided in the following sizes: 2.5 cm^2, 5 cm^2, 7.5 cm^2 and 10 cm^2. The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.
12022643|NCT00423059|Drug|bevacizumab|
12022644|NCT00423046|Biological|GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)|Three doses administered intramuscularly at months 0, 1 and 6
12022645|NCT00423046|Biological|Gardasil ® (Merck & Co. Inc)|Three doses administered intramuscularly at months 0, 2 and 6
12022646|NCT00423046|Biological|Placebo|One dose administered intramuscularly at month 1 to maintain blinding
12022647|NCT00423046|Biological|Placebo|One dose administered intramuscularly at month 2 to maintain blinding
12022648|NCT00423020|Drug|Erythropoietin|
12022649|NCT00423007|Drug|Bromfenac|
12022650|NCT00423007|Drug|Placebo|
12022651|NCT00422994|Drug|ropinirole dosing for up to 28 days|
12022652|NCT00422981|Drug|AL-108|5 mg QD
12022653|NCT00422981|Drug|AL-108|15 mg BID
12022654|NCT00422981|Drug|Placebo|Placebo
12022655|NCT00422968|Device|Percutaneous coronary intervention|Using silorimus eluting stent
12022656|NCT00422968|Procedure|coronary artery bypass graft|coronary artery bypass graft
12022657|NCT00422955|Drug|rosiglitazone|
12022658|NCT00422942|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
12022659|NCT00422942|Drug|Methotrexate|10-25mg po weekly
12022660|NCT00422916|Behavioral|behavioral intervention|
12022661|NCT00422903|Drug|lapatinib|1500 mg administered orally daily
12022662|NCT00422903|Drug|letrozole|2.5 mg administered orally daily
12022663|NCT00422903|Other|placebo|1500 mg administered orally daily
12022664|NCT00422890|Drug|5-Azacytidin|in case of decreasing CD34 chimerism
12022665|NCT00422877|Drug|Taxoprexin|DHA-paclitaxel
12022666|NCT00422864|Drug|oxaliplatin|"Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU).
~Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1."
12022667|NCT00422864|Drug|fluorouracil|"Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1.
~Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy, Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1."
12022668|NCT00422864|Drug|leucovorin|Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
12022669|NCT00422864|Procedure|External beam radiotherapy|Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy, Weeks 8-10: as per Weeks 3-5
12022670|NCT00422838|Procedure|fine-needle aspiration biopsy|aspiration of intrahepatic cells
12022671|NCT00422825|Drug|imatinib|
12022672|NCT00422812|Drug|Inhaled Placebo|Inhaled Staccato Placebo
12022673|NCT00422812|Drug|Inhaled PCZ 5 mg|Inhaled Staccato Prochlorperazine 5 mg
12022674|NCT00422812|Drug|Inhaled PCZ 7.5 mg|Inhaled Staccato Prochlorperazine 7.5 mg
12022675|NCT00422812|Drug|Inhaled PCZ 10 mg|Inhaled Staccato Prochlorperazine 10 mg
12022678|NCT00422786|Drug|CAP-232|Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
12022679|NCT00422773|Drug|Cetuximab|Dose level Infusion time (h) Dose level unit 1 2 3 4 Cetuximab 2.0 mg/m² 500 500 500 500 Irinotecan, before oxaliplatin 1.0 mg/m² 95 125 165 180 Oxaliplatin, with folinic acid 2.0 mg/m² 85 85 85 85 Folinic acid, with folinic acid 2.0 mg/m² 400 400 400 400 5-FU Infusion 46.0 mg/m² 3200 3200 3200 3200
12022680|NCT00422747|Drug|beclomethasondipropionate|2 x 100 ug dd for two months, via aerochamber
12022681|NCT00422734|Drug|tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
12022682|NCT00422734|Drug|Placebo|placebo tablet taken by mouth once a day for 12 weeks
12022683|NCT00422721|Procedure|realization of a family tree|
12022684|NCT00422721|Procedure|refractometry|
12022685|NCT00422721|Procedure|evaluation of the presence of a nystagmus|
12022686|NCT00422721|Procedure|ocular behavior|
12022687|NCT00422721|Procedure|test of baby vision|
12022688|NCT00422721|Procedure|test of keenness|
12022689|NCT00422721|Procedure|reading test|
12022690|NCT00422721|Procedure|visual field|
12022691|NCT00422721|Procedure|color vision|
12022692|NCT00422721|Procedure|electroretinographical activity|
12022693|NCT00422721|Procedure|biomicroscopical test|
12022694|NCT00422721|Procedure|retinal imaging|
12022695|NCT00422721|Procedure|retinal autofluorescence|
12022696|NCT00422721|Procedure|genotyping|
12022697|NCT00422708|Procedure|Local anesthesia|
12022698|NCT00422682|Drug|bsi-201 + topotecan|21 day cycle
12022699|NCT00422682|Drug|bsi-201 + temozolomide|28 day cycle
12022700|NCT00422682|Drug|bsi-201 + gemcitabine|28 day cycle
12022701|NCT00422682|Drug|bsi-201 + carboplatin/paclitaxel|21 day cycle
12022702|NCT00422669|Device|Medtronic Dual-Chamber Pacemaker|A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
12022703|NCT00422669|Device|Medtronic SelectSecure 3830 Lead|Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
12022704|NCT00422656|Drug|Perifosine|
12022705|NCT00422643|Drug|Sodium hyaluronate (hyaluronic acid)|
12022706|NCT00422630|Behavioral|The DASH diet|The DASH diet was originally conceived as the optimal diet for individuals with hypertension, based on epidemiologic and clinical trial data suggesting a beneficial effect of plant-based diets on blood pressure It is a diet rich in fruits, vegetables, whole grains, and low-fat dairy products, with moderate amounts of nuts, legumes, fish, and poultry. Consumption of red meat, sweets, and sugary beverages is limited. As a result, the DASH diet contains more potassium, magnesium, calcium, and fiber and less total fat, saturated fat, cholesterol, simple sugars, and sodium than the average American diet
12022707|NCT00422630|Behavioral|The low glycemic Index Diet|The carbohydrate content of a low GI diet can vary, but many advocates of low GL popular diets suggest a macronutrient profile that is 40% carbohydrate, 30% protein, and 30% fat. These low GL diets are lower in carbohydrate content and higher in protein content than the average American diet. Low GL diets typically contain ample amounts of fruits and vegetables, moderate quantities of nuts, legumes, lean meats, fish, and reduced-fat dairy products, and scant amounts of refined grains, potatoes, and sweets
12022708|NCT00422630|Behavioral|Reduced calorie American Diet|The reduced-calorie diets will provide at least the Recommended Daily Allowance (RDA) for protein (0.8 g/kg/day).
12022709|NCT00422617|Drug|Alefacept (Amevive)|
12022710|NCT00422604|Drug|salmeterol|
12022711|NCT00422604|Drug|tiotropium|
12022712|NCT00422604|Drug|GSK233705|
12022713|NCT00422591|Drug|Cytarabine|1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
12022714|NCT00422591|Drug|Idarubicin|12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
12022715|NCT00422578|Drug|tadalafil|
12022716|NCT00422565|Device|Endeavor, Medtronic|Zotarolimus-eluting stent
12022717|NCT00422565|Device|Cypher, Cordis|Sirolimus-eluting stent
12022718|NCT00422565|Device|Taxus Liberte, Boston Scientific|Paclitaxel-eluting stent
12022719|NCT00422552|Drug|Indacaterol (QAB149)|
12022720|NCT00422539|Drug|70% trichloroacetic acid|
12022721|NCT00422526|Drug|Micronised progesterone (Utrogestan)|
12022722|NCT00422513|Drug|methoxy polyethylene glycol-epoetin beta|120-360 micrograms intravenous (iv) monthly, starting dose
12022723|NCT00422513|Drug|Epoetin alfa|As prescribed, iv, 3 times weekly
12022724|NCT00422500|Behavioral|Questionnaire|Surveys about symptoms, mood, and quality of life.
12022725|NCT00422500|Behavioral|Telephone Interactive System|Automated telephone system call once a week during therapy, rating of severity of symptoms and daily life interference done with numeric key pad. Post therapy is complete, a call every two weeks for up to six months.
12022726|NCT00422500|Other|Blood Samples|For participating patients, 3 additional tablespoons of blood drawn at the beginning of each chemotherapy treatment (before treatment starts) and at the beginning of each cycle of treatment.
12022727|NCT00422487|Drug|MBX-2044|MBX-2044 1.5 mg one capsule daily for 14 days
12022728|NCT00422487|Drug|MBX-2044|MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
12022729|NCT00422487|Drug|MBX-2044|MBX-2044 15 mg one capsule daily for 14 days
12022730|NCT00422487|Drug|MBX-2044|MBX-2044 30 mg two 15 mg capsules daily for 14 days
12022731|NCT00422487|Drug|MBX-2044|MBX-2044 60 mg one capsule daily for 14 days
12022732|NCT00422487|Drug|MBX-2044|MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
12022733|NCT00422487|Drug|Placebo for MBX-2044|Placebo Intervention
12022734|NCT00422461|Drug|PF-00489791|PF-00489791 4 mg, oral, tablets, once daily, for 28 days
12022735|NCT00422461|Drug|PF-00489791|PF-00489791 10 mg, oral, tablets, once daily, for 28 days
12022736|NCT00422461|Drug|PF-00489791|PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days
12022737|NCT00422461|Drug|placebo|placebo, oral, tablets, once daily, for 28 days
12022738|NCT00422448|Genetic|To test the frequency of BRAF and NRAS mutations among nevi|Benign nevi excised for the study purpose where genetically analyzed for the presence/absence of BRAF and NRAS mutations
12022739|NCT00422435|Device|CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter|Paclitaxel-Eluting Coronary Stent
12022740|NCT00422422|Drug|Brivaracetam|"Oral solution
~Evaluation period (3 weeks up-titration):
~For subjects ≥8 years:
~~0.4 mg/kg bid for Week 1
~~0.8 mg/kg bid for Week 2
~~1.6 mg/kg bid for Week 3
~For subjects <8 years:
~~0.5 mg/kg bid for Week 1
~~1.0 mg/kg bid for Week 2
~~2.0 mg/kg bid for Week 3
~Down-titration period (up to 2 weeks):
~For subjects ≥8 years:
~~0.8 mg/kg bid for Week 4
~~0.4 mg/kg bid for Week 5
~For subjects <8 years:
~~1.0 mg/kg bid for Week 4
~~0.5 mg/kg bid for Week 5"
12022741|NCT00422409|Procedure|Endoscopic stenting|
12022742|NCT00422396|Drug|Fenofibrate (drug)|
12022743|NCT00422383|Drug|rituximab [MabThera/Rituxan]|500mg iv in days 1 and 15, and 500mg iv on days 168 and 182
12022744|NCT00422383|Drug|rituximab [MabThera/Rituxan]|500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182
12022745|NCT00422383|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182
12022746|NCT00422370|Device|lipid based additives based on vegetable oil & lecithin|
12022747|NCT00422357|Drug|Urtica Dioica (Tea bag)|
12022748|NCT00422344|Drug|RAD001, Sunitinib|Patients will start treatment with Sunitinib and RAD001 on Cycle 1, Day 1. Sunitinib will be given orally daily for 4 weeks followed by a 2 week rest period. RAD001 will be given orally daily or weekly in subsequent cohorts with the first treatment on day 1. DLT determination will be based on toxicities observed in Cycles 1 - a cycle being defined by Sunitinib dosing. Once the MTD for the combination has been identified, a total of 10 patients will be enrolled into the study at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs
12022749|NCT00422331|Drug|Lithium Carbonate Capsule|
12022750|NCT00422318|Drug|Benzbromarone (drug)|
12022751|NCT00422292|Biological|Meningococcal Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL dose, intramuscular (IM)
12022752|NCT00422292|Biological|Meningococcal Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL dose, IM
12022753|NCT00422292|Biological|Meningococcal Polysaccharide Diphtheria Conjugate Vaccine|0.5 Ml dose, IM
12022754|NCT00422292|Biological|Measles, Mumps, Rubella and Varicella|0.5 mL dose, SC
12022755|NCT00422279|Device|Nobel Replace Tapered Groovy|Bone inductive implant placed in supralveoral position or extraction site
12022756|NCT00422266|Drug|Omega 3 fatty acids and plant sterol enriched drink|
12022757|NCT00422266|Dietary Supplement|Omega 3 fatty acids and plant sterols|Capsules and Yoghurt based minidrink
12022758|NCT00422253|Behavioral|dietary intervention|
12022759|NCT00422240|Drug|Adapalene/Benzoyl Peroxide|
12022760|NCT00422227|Drug|Etanercept , Methotrexate|"Etanercept: 25 mg twice weekly over 16 weeks, SC
~Methotrexate: > 7.5 mg/week and no more than 25 mg/week, PO"
12022761|NCT00422227|Drug|Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide|"Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
~Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
~Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
~Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily"
12022762|NCT00422214|Drug|Quetiapine fumarate (Seroquel) SR|
12022763|NCT00422201|Drug|Mifepristone|Singe dose
12022764|NCT00422188|Drug|Deoxycholic Acid Injection|Administered via intralipomal injection.
12022765|NCT00422188|Drug|Placebo|Administered via intralipomal injection.
12022766|NCT00422175|Drug|BAF 312|
12022767|NCT00422162|Drug|Duloxetine hydrochloride|60 mg once or twice a day, by mouth
12022768|NCT00422162|Drug|Placebo|placebo capsule by mouth
12022769|NCT00422149|Drug|SUBLIVAC® Grasses/Placebo treatment|SUBLIVAC® Grasses/Placebo treatment
12022770|NCT00422149|Drug|SUBLIVAC® Grasses treatment|SUBLIVAC® Grasses treatment
12022771|NCT00422149|Drug|Placebo treatment|Placebo treatment
12022772|NCT00422123|Drug|Quetiapine fumarate (Seroquel) SR|
12022773|NCT00422110|Drug|Seletracetam|
12022774|NCT00422097|Drug|Ixabepilone, 5 mg/d|Ixabepilone, 5 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
12022775|NCT00422097|Drug|Ixabepilone, 10 mg/d|Ixabepilone, 10 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
12022776|NCT00422097|Drug|Ixabepilone, 15 mg/d|Ixabepilone, 15 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
12022777|NCT00422097|Drug|Ixabepilone, 20 mg/d|Ixabepilone, 20 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
12022778|NCT00422097|Drug|Ixabepilone, 25 mg/d|Ixabepilone, 25 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
12022779|NCT00422097|Drug|Ixabepilone, 30 mg/d|Ixabepilone, 30 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
12022780|NCT00422097|Drug|Ixabepilone, 25 mg, with famotidine|Participants crossed over from Cycle 1 to receive famotidine, 40 mg, in an oral dose given 2 hours before ixabepilone, 25 mg, on Day 1 of Cycle 2 only.
12022943|NCT00420784|Drug|Pegylated Interferon Alfa 2a|Solution for injection
12022781|NCT00422097|Drug|Ixabepilone, 25 mg, with food|Participants consume a low-fat meal starting 30 minutes before dose administration on Day 1 of Cycle 2. Food consumed within 30 minutes. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
12022782|NCT00422084|Drug|Pyronaridine artesunate|once a day for 3 days
12022783|NCT00422084|Drug|Coartem® (artemether lumefantrine)|twice a day for 3 days
12022784|NCT00422058|Drug|liraglutide|Injected s.c. (under the skin) once daily
12022785|NCT00422058|Drug|orlistat|120 mg capsule. Administered thrice daily
12022786|NCT00422058|Drug|placebo|Injected s.c. (under the skin) once daily
12022787|NCT00422045|Device|Low Level Laser Therapy|Low Level Laser Therapy done after surgery.
12022788|NCT00422032|Drug|Clofarabine|"Group A: 15 mg/m^2 IV over 1 hour daily for 5 days
~Group B: 30 mg/m^2 IV over 1 hour daily for 5 days"
12022789|NCT00422019|Drug|AMG 102 at 10 mg/kg|AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
12022790|NCT00422019|Drug|AMG 102 at 20 mg/kg|AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks
12022791|NCT00422006|Procedure|biopsy of muscle, of liver, and of adipose tissue|biopsy of muscle, of liver, and of adipose tissue
12022792|NCT00422006|Procedure|clamp euglycemic - hyperglycemic|clamp euglycemic-hyperglycemic
12022793|NCT00422006|Behavioral|diet|diet
12022794|NCT00422006|Other|biopsies for biological and genetic analyses|biopsies for biological and genetic analyses
12022795|NCT00421993|Drug|Adapalene/Benzoyl Peroxide|Topical Gel, One application daily in the evening for 12 weeks
12022796|NCT00421993|Drug|Adapalene|Topical Gel,One application daily in the evening for 12 weeks
12022797|NCT00421993|Drug|Benzoyl Peroxide|Topical Gel, one application daily in the evening for 12 weeks
12022798|NCT00421993|Drug|Topical Gel Vehicle|Topical Gel Vehicle,one application daily in the evening for 12 weeks
12022799|NCT00421980|Drug|Etanercept|
12022800|NCT00421967|Drug|Ropivacaine, Ketorolac, adrenaline|Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac
12022801|NCT00421967|Drug|Ropivacaine Ketorolac|Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg
12022802|NCT00421954|Drug|Ziprasidone|subjects will use ziprasidone
12022803|NCT00421941|Procedure|Tube feeding|
12022804|NCT00421928|Drug|oxycodone|10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks
12022805|NCT00421928|Drug|placebo|matching placebo twice a day (BID) during 15 weeks
12022806|NCT00421928|Drug|tapentadol (CG5503)|50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks
12022807|NCT00421915|Drug|Enbrel (etanercept)|
12022808|NCT00421902|Procedure|Acupuncture|Patients will be have acupuncture (with electro stimulation)
12022809|NCT00421889|Drug|belinostat|
12022810|NCT00421889|Drug|Paclitaxel|
12022811|NCT00421889|Drug|Carboplatin|
12022812|NCT00421876|Behavioral|multifactorial continued educational - behavioural programme|
12022813|NCT00421863|Drug|Triatec 10 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022814|NCT00421863|Drug|Triatec HCT 5|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022815|NCT00421863|Drug|Lasix 25|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022816|NCT00421863|Drug|Micardis 80 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022817|NCT00421863|Drug|Micardis plus 80/12.5|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022818|NCT00421863|Drug|Catapresan TTS 2|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022819|NCT00421863|Drug|Norvasc 10 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022820|NCT00421863|Drug|Triatec 5 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022821|NCT00421863|Drug|Pluscor|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
12022822|NCT00421850|Behavioral|UNITED Planned Care|
12022823|NCT00421824|Drug|Oxaliplatin, capecitabine|OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery
12022824|NCT00421824|Drug|Oxaliplatin, capecitabine|XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.
12022825|NCT00421811|Drug|ADH-1|4 gm IV Days 1 and 8
12022826|NCT00421811|Drug|melphalan|By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1
12022827|NCT00421785|Drug|Oral N-Acetylcysteine 1200 mg x 2/day for 4 weeks.|
12022828|NCT00421759|Device|Vibrating Insoles|Participants wear vibrating sandals for 3 trials of 6 minutes, during a single lab visit. The sandal vibration is on during either first or second 3 minutes of the 6 minute trial, as they walk. Also, participants wear the sandals for 2 hours while sitting, with vibrations on for one visit and off for the other.
12022829|NCT00421746|Drug|Piboserod|
12022830|NCT00421733|Drug|Zemplar (paricalcitol ) capsules|Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)
12022831|NCT00421733|Drug|Zemplar (paricalcitol) capsules|Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)
12022832|NCT00421733|Drug|Placebo|Group 1 - Placebo once daily (two placebo capsules once daily)
12022833|NCT00421720|Drug|Sufentanil|
12022834|NCT00421720|Drug|Remifentanil|
12022835|NCT00421707|Drug|GW876008|
12022836|NCT00421707|Other|Placebo|
12022837|NCT00421694|Drug|Bicalutamide|
12022944|NCT00420784|Drug|Matching Placebo|Tablet
12023074|NCT00419770|Drug|Liposomal amphotericin B|
12022838|NCT00421681|Behavioral|Fit and Strong! Exercise Program|Fit and Strong! is an 8-week (24 sessions) multi-component exercise and health education intervention, including flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Following participation in Fit and Strong!, all study participants are randomly assigned to one of 2 maintenance treatment follow-up groups.
12022839|NCT00421668|Drug|Zinc|zinc
12022840|NCT00421668|Drug|Multivitamins|Vitamins C, E, B1, B2, niacin, B6, folate and B12
12022841|NCT00421668|Drug|Placebo|Placebo
12022842|NCT00421655|Drug|Grazax|Tablets 75,000 SQT and matching placebo. One tablet daily.
12022843|NCT00421642|Drug|Adalimumab|The loading dose will be 160 mg. A dose of 80 mg will be given at Week 2 and 40 mg every other week starting at Week 4 until completion at Week 24. If it is found that they are not responding to 40 mg of adalimumab at Week 8 or later, the dose may be increased to 40 mg weekly.
12022844|NCT00421629|Behavioral|After-sales service and supportive supervision (AfterSS)|
12022845|NCT00421629|Behavioral|Prospective reimbursement (PR)|
12022846|NCT00421629|Behavioral|Both (AfterSS and PR)|
12022847|NCT00421616|Behavioral|High protein diet study|
12022848|NCT00421603|Drug|Adderall-XR and Topiramate|Adderall-XR 60mg/day and Topiramate 300mg/day
12022849|NCT00421603|Drug|Placebo|Placebo
12022850|NCT00421590|Drug|SMC021|
12022851|NCT00421564|Drug|DBT-Danggui Buxue Tang|
12022852|NCT00421551|Drug|Darunavir|during the 48 first weeks of the trial, (2x300mg) twice a day between W48 and W96, (2x400mg) once a day
12022853|NCT00421551|Drug|ritonavir|during the first 48 weeks, 100mg twice a day between W48 and W96, 100mg once a day
12022854|NCT00421538|Drug|nadroparine calcium|Once-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks.
12022855|NCT00421538|Drug|Placebo|Once-daily injectable placebo (sterilized NaCL 0.9%) for 6 weeks
12022856|NCT00421525|Biological|milatuzumab|twice weekly dosing for 4 weeks, total of 8 doses
12022857|NCT00421512|Drug|Bevacizumab and Sunitinib|On Cycle 1, Day 0, patients will begin treatment with bevacizumab. Sunitinib will begin on Day 1. The starting dose for sunitinib will be 25mg orally daily. sunitinib will be given in a four weeks on-two weeks off schedule. Bevacizumab will begin on Day 0 and will be administered every two weeks at 10mg/kg. A cycle of therapy is 6 weeks. The sunitinib dose escalation portion of the trial will be performed to determine the MTD of sunitinib given in combination with bevacizumab. Once the MTD has been determined, 10 additional patients will be treated at the MTD of sunitinib in combination with bevacizumab.
12022858|NCT00421499|Drug|dark chocolate|
12022859|NCT00421486|Procedure|Oral swabs for HPV-typing and high-risk HPV-determination|Oral swabs for HPV-typing and high-risk HPV-determination
12022860|NCT00421473|Drug|Atovaquone / Proguanil|
12022861|NCT00421460|Drug|Testosterone Undecanoate,1000mg|duration for 4 injections
12022862|NCT00421447|Drug|Anastrozole|Group of women with breast cancer
12022863|NCT00421434|Drug|Nitazoxanide|One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
12022864|NCT00421434|Biological|Peginterferon alfa-2a|Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
12022865|NCT00421434|Biological|Peginterferon alfa-2a|Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
12022866|NCT00421434|Drug|Ribavirin|Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
12022867|NCT00421434|Drug|Ribavirin|Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.
12022868|NCT00421421|Drug|Dutasteride|
12022869|NCT00421408|Dietary Supplement|Whey protein supplement|40-g whey protein supplement daily for 18 months
12022870|NCT00421408|Dietary Supplement|Placebo|Placebo supplement daily for 18 months
12022871|NCT00421395|Biological|90Y-hLL2|weekly dosing for either 2 or 3 weeks
12022872|NCT00421369|Drug|sertraline|
12022873|NCT00421369|Drug|triiodothyronine (T3)|
12022874|NCT00421369|Drug|reboxetine|
12022875|NCT00421343|Drug|alendronate with cholecalciferol|alendronate 70mg /cholecalciferol 2800IU orally once weekly
12022876|NCT00421343|Drug|calcium carbonate with cholecalciferol|calcium carbonate 500mg /cholecalciferol 200IU orally twice daily
12022877|NCT00421343|Behavioral|Falls prevention measures|personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications
12022878|NCT00421330|Procedure|Open Aneurysm Repair|
12022879|NCT00421330|Procedure|Endovascular Aneurysm Repair|
12022880|NCT00421317|Drug|Imatinib|800 mg/day until disease progression or toxicity
12022881|NCT00421304|Biological|Motavizumab|Will receive a single dose of IV of Motavizumab (100mg/kg)
12022882|NCT00421304|Other|Biological/Vaccine: Motavizumab|A single IV dose of placebo (30 mg/kg).
12022883|NCT00421304|Other|Placebo|A single IV dose of placebo (30 or 100 mg/kg).
12022884|NCT00421291|Behavioral|Education|
12022885|NCT00421278|Drug|MK0633|Single dose MK0633 100mg po in the fed state administered during a 4-wk study.
12022886|NCT00421252|Drug|clopidogrel 600 mg|Clopidogrel load > 2hrs pre-angiography
12022887|NCT00421252|Device|arterial access sheath|randomize to 5Fr vs 6Fr
12022888|NCT00421226|Drug|ACZ885|
12022889|NCT00421213|Drug|Darinaparsin|300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
12022890|NCT00421200|Drug|Hemospan (MP4OX)|250 ml unit dose, up to 500 mL total dose, as needed at protocol-defined dosing triggers
12022891|NCT00421200|Drug|Voluven (HES 130/0.4)|250 ml unit dose, up to 500 mL total dose, as needed at protocol-defined dosing triggers
12022892|NCT00421187|Drug|Liposomal amphotericin B (AmBisome®)|
12022893|NCT00421187|Drug|Liposomal amphotericin B (AmBisome®)|
12022894|NCT00421174|Drug|Etanercept|Etanercept will be given eight doses of study drug over a 4-week period. The initial dose of etanercept will be administered intravenously on Day 0, with subsequent doses administered subcutaneously (SQ). Dosing will be administered twice weekly over 4 consecutive weeks. Additionally, patients in both arms will receive corticosteroids (2 mg/kg/day) Day 0 through Day 7, with subsequent taper as clinically indicated.
12023006|NCT00420342|Drug|Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)|SH K 00641 B - Active study medication encapsulated tablet
12022895|NCT00421174|Drug|Placebo plus corticosteroid|"Patients will receive a total of eight doses of placebo over a 4-week period. The initial dose of placebo will be administered intravenously on Day 0, with subsequent doses administered subcutaneously (SQ). Dosing will be administered twice weekly over 4 consecutive weeks. The placebo will be the inert diluent used for the etanercept formulation.
~Additionally, patients in both arms will receive corticosteroids (2 mg/kg/day) Day 0 through Day 7, with subsequent taper as clinically indicated."
12022896|NCT00421161|Drug|olive oil and omega 3 in a combined cream|
12022897|NCT00421148|Drug|Sugammadex 0.5 mg/kg|IV infusion
12022898|NCT00421148|Drug|Sugammadex 1 mg/kg|IV infusion
12022899|NCT00421148|Drug|Sugammadex 2 mg/kg|IV infusion
12022900|NCT00421148|Drug|Sugammadex 4 mg/kg|IV infusion
12022901|NCT00421148|Drug|Placebo|IV infusion
12022902|NCT00421148|Drug|Rocuronium bromide|IV infusion
12022903|NCT00421135|Drug|ZIO-201|ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.
12022904|NCT00421122|Drug|budesonide/formoterol (Symbicort)|inhalation therapy
12022905|NCT00421122|Drug|budesonide (Pulmicort)|inhalation
12022906|NCT00421122|Drug|terbutaline sulfate (Bricasol)|inhalation therapy
12022907|NCT00421109|Drug|Bilastine|Encapsulated 20 mg Tablet. Once daily for 28 days
12022908|NCT00421109|Drug|Levocetirizine|Encapsulated 5 mg tablet. Once daily for 28 days
12022909|NCT00421109|Drug|Placebo|Encapsulated tablet. Once daily for 28 days
12022910|NCT00421096|Drug|Gemcitabine|125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
12022911|NCT00421096|Procedure|Radiotherapy|"45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)
~+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area"
12022912|NCT00421096|Drug|Cisplatin|40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration
12022913|NCT00421083|Drug|tadalafil|
12022914|NCT00421070|Procedure|Massage therapy|A qualified massage therapist will administer a 20-minute standard massage procedure with the client sitting fully clothed in a special massage chair. The massage therapy session will consist of ; 1) long, broad stroking with light-moderate pressure to the back, compression to the back (parallel to spine) from the shoulders to base of spine, trapezius squeeze, finger pressure on the shoulder; 2) arms dropped to the side with arms kneaded from shoulder to lower arm and pressing down on upper and lower arms; 3) entire hands massaged and pulling of fingers, light kneading to area of cervical vertebrae, pressing down on trapezius with finger pressure and squeezing continuing down the arms.
12022915|NCT00421057|Behavioral|Combined Strength Training and Functional Endurance Exercise|Participants will be taught to stretch a Theraband as far as your arms or legs can stretch and the proper posture for walking for exercise. The Estimated Timed-Get-Up and Go test (ETGUPGo) and a 6-minute walk test will be performed to check your level of fatigue and physical ability.
12022916|NCT00421057|Behavioral|Questionnaire|Questionnaires taking approximately 30 minutes total to complete.
12022917|NCT00421044|Drug|Patupilone/EPO906|
12022918|NCT00421031|Drug|DVS-233 SR|
12022919|NCT00421018|Drug|Single corticosteroid inhalers and Singulair|Treatment steps according to preset algorithm
12022920|NCT00421005|Drug|fluvastatin|Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations
12022921|NCT00420992|Drug|ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)|capsules, up to 80 mg bid
12022922|NCT00420992|Drug|Placebo|capsules, bid
12022923|NCT00420953|Drug|Cordarone|
12022924|NCT00420940|Device|Juvent 1000 Dynamic Motion Therapy (DMT) Platform|Standing on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g
12022925|NCT00420940|Device|Juvent 1000 Dynamic Motion Therapy (DMT) Platform|Standing on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g
12022926|NCT00420927|Biological|adalimumab|Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
12022927|NCT00420927|Drug|methotrexate|Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.
12022928|NCT00420927|Biological|placebo|Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
12022929|NCT00420914|Procedure|low dose of 2.25 x 10^11 platelets/transfusion (range 1.5 to 2.9)|
12022930|NCT00420901|Drug|sildenafil|
12022931|NCT00420888|Drug|ABR-217620/naptumomab estafenatox|10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
12022932|NCT00420888|Drug|IFN-alpha|3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
12022933|NCT00420875|Device|TOPAZ MicroDebrider|The TOPAZ MicroDebrider will be used for patients that fail conservative care. Under sterile conditions in the operating room, patients will be given intravenous sedation (drugs that make you sleepy and unaware of your surroundings) in a hand vein and local anesthetic (drugs to numb the area where the surgical procedure will be done). Depending on the technique used the study doctor may or may not make an incision (cut) about 1 inch long on the side of your foot to expose your tendon. If the study doctor chooses to use the percutaneous method, an incision will not be made. The study doctor will put the tip of the TOPAZ MicroDebrider device (which is about 1/16th of an inch long) into the tendon. A current of energy will be applied on and around the tendon. Steri strips will be placed on the skin to close the area treated.
12022934|NCT00420862|Procedure|Spiral Computed Tomography|
12022935|NCT00420849|Drug|Lenalidomide|Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles.
12022936|NCT00420849|Drug|Dexamethasone|Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
12022937|NCT00420836|Drug|Tobramycin|
12022938|NCT00420823|Drug|Taurine 4g|
12022939|NCT00420810|Drug|MK0928 / Duration of Treatment : 8 Weeks|
12022940|NCT00420797|Drug|10% Phenylephrine hydrochloride gel|
12022941|NCT00420784|Drug|Telaprevir|tablet
12022942|NCT00420784|Drug|Ribavirin|tablet
12023073|NCT00419770|Drug|Placebo|
12022945|NCT00420771|Drug|Gabapentin|For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsules taken 3 times per day for 3 days, then one 400 mg Gabapentin capsule taken 3 times per day for 4 days. Placebo study medication appears identical to active medication and is prescribed with an identical dosing schedule.
12022946|NCT00420771|Drug|Placebo|placebo comparator appears identical to active medication and is prescribed with an identical dosing schedule with a maximum dose of 400mg taken three times per day
12022947|NCT00420758|Dietary Supplement|Food supplement: fortified spread|Provision of fortified spread
12022948|NCT00420758|Dietary Supplement|Food supplement: maize-soy flour|Provision of corn-soy blend (maize-soy flour)
12022949|NCT00420745|Biological|Rotarix™|Two-dose oral vaccination.
12022950|NCT00420745|Biological|Placebo|Two-dose oral administration
12022951|NCT00420732|Biological|HyperAcute-Lung Cancer Vaccine|300 million cells given intradermally every 3 weeks for up to a total of 12 vaccinations
12022952|NCT00420719|Device|Intramuscular diaphragm electrodes|Conditioning of the diaphragm
12022953|NCT00420706|Drug|SCA-136|
12022954|NCT00420693|Drug|sevoflurane|
12022955|NCT00420680|Drug|Sugammadex|Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium
12022956|NCT00420680|Drug|Sugammadex|Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.
12022957|NCT00420680|Drug|Placebo|Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium
12022958|NCT00420667|Drug|Enoxaparin|
12022959|NCT00420654|Drug|Growth Hormone|1.25 mg, 6 months
12022960|NCT00420654|Drug|Placebo|Equivalent to 1.25 mg, 6 months
12022961|NCT00420654|Other|Healthy controls|Healthy controls
12022962|NCT00420641|Drug|GSK372475|GSK372475 1.0-1.5 mg/day
12022963|NCT00420641|Drug|Paroxetine|Paroxetine 20-30 mg/day
12022964|NCT00420641|Other|Placebo|Placebo to Match
12022965|NCT00420628|Drug|loteprednol etabonate/tobramycin opthalmic suspension|Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
12022966|NCT00420628|Drug|vehicle|topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
12022967|NCT00420615|Drug|Patupilone and Omeprazole|
12022968|NCT00420615|Drug|Patupilone + Midalzolam|
12022969|NCT00420602|Dietary Supplement|Over the counter DHA/EPA dietary supplementation|1000 mg/day DHA/EPA
12022970|NCT00420589|Drug|taranabant|taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
12022971|NCT00420589|Drug|Comparator: placebo|Placebo capsules once daily. Treatment for 52 weeks
12022972|NCT00420576|Drug|DBT-Danggui Buxue Tang|Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment
12022973|NCT00420563|Drug|CYCLOPHOSPHAMIDE|50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
12022974|NCT00420563|Drug|MEGESTROL|320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision
12022975|NCT00420550|Behavioral|Relaxation Response using Guided Imagery|
12022976|NCT00420537|Drug|cyclosporine|cyclosporine trough levels between 100 and 150
12022977|NCT00420537|Drug|cyclosporine|cyclosporine trough levels between 40 and 90 ng/ml
12022978|NCT00420537|Drug|Mycophenolate mofetil|mycophenolate with low doses
12022979|NCT00420537|Drug|Everolimus|
12022980|NCT00420524|Drug|Patupilone/EPO906|
12022981|NCT00420511|Drug|Sitagliptin|sitagliptin 100 mg once a day
12022982|NCT00420511|Drug|Placebo|placebo once a day
12022983|NCT00420511|Drug|metformin|metformin 1000 mg twice a day (bid) by mouth (po)
12022984|NCT00420498|Drug|Atomoxetine (Strattera™)|
12022985|NCT00420485|Drug|gimatecan|
12022986|NCT00420472|Drug|mycophenolate mofetil [CellCept]|
12022987|NCT00420459|Drug|Aripiprazole|All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.
12022988|NCT00420446|Behavioral|Adjusted diet|
12022989|NCT00420433|Procedure|Skeletal Scintigraphy|Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
12022990|NCT00420433|Procedure|Radiography|Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
12022991|NCT00420433|Procedure|CT Scan|CT scan will include your chest, abdomen, and pelvis. Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
12022992|NCT00420420|Drug|MK0249|MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.
12022993|NCT00420420|Drug|Comparator: Placebo (unspecified)|MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period
12022994|NCT00420407|Drug|normal saline control|no vasopressin added to bolus or 5 hour continuous infusion
12022995|NCT00420407|Drug|vasopressin|vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
12022996|NCT00420394|Procedure|Chemotherapy|
12022997|NCT00420394|Procedure|surgery|
12022998|NCT00420394|Procedure|radiotherapy|
12022999|NCT00420381|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until progressive disease
12023000|NCT00420368|Dietary Supplement|No food supplement|
12023001|NCT00420368|Dietary Supplement|Food supplement: fortified spread|
12023002|NCT00420368|Dietary Supplement|Food supplement: maize-soy flour|
12023003|NCT00420355|Drug|atazanavir|Atazanavir 300 mg daily on Days 6-12.
12023004|NCT00420355|Drug|lopinavir/ritonavir|Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.
12023005|NCT00420342|Drug|Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)|SH K 00641 A -Active study medication encapsulated tablet
12023301|NCT00417820|Drug|BCT194|
12023007|NCT00420342|Drug|SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)|Active control encapsulated tablet
12023008|NCT00420316|Biological|Rotarix (primary vaccination study)|GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
12023009|NCT00420316|Biological|Placebo (primary vaccination study)|Two liquid oral doses of placebo
12023010|NCT00420303|Drug|Etanercept|50 mg injection once weekly
12023011|NCT00420303|Other|Placebo|placebo
12023012|NCT00420290|Drug|kineret|100 mg administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
12023013|NCT00420290|Drug|placebo|100 mg administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
12023014|NCT00420277|Drug|Hemospan (MP4OX)|250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
12023015|NCT00420277|Drug|Voluven (HES 130/0.4)|250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
12023016|NCT00420264|Device|Uterine Ablation|Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation
12023017|NCT00420251|Drug|Genotropin|
12023018|NCT00420238|Drug|Etanercept (Enbrel)|50 mg injection once weekly
12023019|NCT00420238|Other|Placebo|placebo
12023020|NCT00420225|Device|Low-weight prolypropylene mesh|
12023021|NCT00420212|Drug|BG00012|
12023022|NCT00420212|Drug|Placebo|
12023023|NCT00420199|Drug|Abatacept|Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment
12023024|NCT00420199|Drug|Placebo|Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment
12023025|NCT00420186|Drug|BMS-690514|Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos
12023026|NCT00420173|Procedure|Laboratory analysis|blood withdrawal
12023027|NCT00420160|Behavioral|Smoking cessation treatment plus moderate intensity exercise|
12023028|NCT00420160|Behavioral|Smoking cessation treatment plus health education|
12023029|NCT00420147|Device|wedged inshoe orthosis|Treatment subjects were prescribed an inshoe wedged orthosis
12023030|NCT00420147|Device|neutral inshoe orthosis|Control subjects were prescribed a neutral inshoe orthosis
12023031|NCT00420134|Procedure|injection of progenitor of hepatocyte drived from Mesenchymal stem cell|
12023032|NCT00420121|Procedure|laboratory analysis|blood withdrawal for laboratory analysis
12023033|NCT00420095|Drug|Human insulin 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
12023034|NCT00420095|Drug|Insulin lispro low mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
12023035|NCT00420082|Drug|Bilastine|Encapsulated Bilastine 20 mg tablets Q.D.
12023036|NCT00420082|Drug|Fexofenadine|Encapsulated Fexofenadine 120 mg tablets Q.D.
12023037|NCT00420082|Drug|Cetirizine|Encapsulated Cetirizine 10 mg tablets Q.D.
12023038|NCT00420082|Drug|Placebo|Encapsulated Placebo tablets Q.D.
12023039|NCT00420069|Device|MRTX device|device for ventilation
12023040|NCT00420056|Drug|PD-0332991|125 mg, oral, Days 1-21 of a 28-day cycle
12023041|NCT00420043|Drug|imatinib|
12023042|NCT00420030|Drug|Abciximab|Abciximab - IIb/IIIa GP inhibitor, dosage - bolus + continuous infusion
12023043|NCT00420017|Drug|Amiodarone|Intravenous amiodarone continuous infusion x 4 days
12023044|NCT00420017|Other|Control|No amiodarone
12023045|NCT00420004|Drug|LY2216684|3-mg and 6-mg tablets
12023046|NCT00420004|Drug|Placebo|
12023047|NCT00420004|Drug|Escitalopram|10-mg capsules
12023048|NCT00419991|Drug|Tigecycline|All patients will receive tigecycline infusions approximately every 12 or 24 hours. The usual regimen of tigecycline is (an initial intravenous (IV) dose of 100 mg followed by 50 mg approximately every 12 hours). Patients with severe hepatic dysfunction may, at the investigator's discretion with CPL Associates approval (call enrollment hotline) may be given a total daily dose of 50 mg (one 50 mg dose or 25 mg approximately every 12 hours). Tigecycline infusions will be administered over approximately 30 minutes in 100 mL of normal saline.
12023049|NCT00419978|Procedure|Colectomy|
12023050|NCT00419952|Drug|Budesonide/formoterol (SYMBICORT) pMDI|Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
12023051|NCT00419952|Drug|Budesonide HFA pMDI|Budesonide HFA pMDI 160 ug x 2 actuations BID
12023052|NCT00419926|Drug|Enteric-coated mycophenolate sodium (Myfortic)|1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
12023053|NCT00419926|Drug|Cyclosporine (Neoral)|cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels
12023054|NCT00419926|Drug|Prednisone|20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.
12023055|NCT00419913|Dietary Supplement|Dehydroepiandrosterone|DHEA 25 mg tid
12023056|NCT00419900|Procedure|diagnosis of breast cancer by x-ray diffraction of hair|
12023057|NCT00419887|Drug|Vildagliptin (LAF237)|
12023058|NCT00419848|Drug|Doxycycline|Cap 100mg- 100mg/daily
12023059|NCT00419848|Drug|Azithromycin|Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
12023060|NCT00419835|Drug|enalapril|
12023061|NCT00419835|Drug|losartan|
12023062|NCT00419822|Procedure|Acupuncture|6 Acupuncture visits
12023063|NCT00419822|Procedure|Sham Acupuncture|6 Acupuncture visits with sham procedure
12023064|NCT00419822|Other|Patient to receive standard care without Acupuncture or Sham Acupuncture.|Standard care
12023065|NCT00419809|Drug|SB-681323 oral tablets|
12023066|NCT00419796|Drug|Lumiracoxib|
12023067|NCT00419783|Drug|bilastine|20 mg tablets.
12023068|NCT00419783|Drug|Bilastine|100 mg (5 tablets of 20 mg)
12023069|NCT00419783|Drug|Bilastine & Ketoconazole|1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet
12023070|NCT00419783|Drug|Moxifloxacin|1 capsule containing moxifloxacin 400 mg tablet
12023071|NCT00419783|Drug|Placebo|Placebo tablets
12023072|NCT00419770|Drug|deferasirox|20 mg/kg enterally per day
12023075|NCT00419757|Drug|Budesonide/formoterol (SYMBICORT) pMDI|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
12023076|NCT00419757|Drug|Budesonide HFA pMDI|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
12023077|NCT00419744|Drug|Budesonide/formoterol (SYMBICORT) pMDI|
12023078|NCT00419744|Drug|Formoterol Turbuhaler|
12023079|NCT00419731|Drug|Bupropion|"Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.
~Placebo, 25 mg, q.d., for 7 weeks."
12023080|NCT00419731|Drug|Bupropion + Naltrexone|"Bupropion, Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.
~Naltrexone, 25 mg, q.d., for 7 weeks."
12023081|NCT00419718|Drug|inhaled human insulin|
12023082|NCT00419705|Device|NeuroThera® Laser System|Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
12023083|NCT00419692|Drug|Ropinirole|Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51.
12023084|NCT00419679|Procedure|x-ray diffraction of human hair|
12023085|NCT00419666|Drug|Calcitriol 3mcg/g|Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
12023086|NCT00419653|Drug|Amisulpride|
12023087|NCT00419653|Drug|Olanzapine|
12023088|NCT00419653|Drug|Haloperidol|
12023089|NCT00419640|Device|Pacemaker implantation with RA lead in LAS position|Pacemaker implantation with RA lead placed in low atrial septal position
12023090|NCT00419640|Device|Pacemaker implantation with RA lead in LAS position|Pacemaker implantation with RA lead placed in low atrial septal position
12023091|NCT00419640|Device|Pacemaker implantation with RA lead in RAA position|Pacemaker implantation with RA lead placed in right atrial appendage position
12023092|NCT00419640|Device|Pacemaker implantation with RA lead in RAA position|Pacemaker implantation with RA lead placed in right atrial appendage position
12023093|NCT00419601|Drug|Remifentanyl|Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h
12023094|NCT00419601|Drug|Fentanyl|start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h
12023095|NCT00419562|Drug|Oral Insulin|7.5 mg oral insulin or placebo given before breakfast on a daily basis.
12023096|NCT00419562|Drug|Placebo|Placebo capsule designed to match active drug
12023097|NCT00419549|Drug|Glyceryl - trinitrate|Transdermal Patch once only
12023098|NCT00419549|Drug|Valdecoxib|Single parenteral administration
12023099|NCT00419536|Drug|LBH589|
12023100|NCT00419510|Behavioral|Culturally Tailored Genetic Counseling|
12023101|NCT00419497|Behavioral|Paleolithic diet vs Mediterranean diet|Prudent diets with or without grains and dairy
12023102|NCT00419484|Drug|pioglitazone|
12023103|NCT00419471|Drug|Escitalopram|Study medication will be provided as 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day, and matched placebo. The initial dose of escitalopram was 10mg/day generally, but 5mg/day for those aged 65 or over and with hepatic dysfunction. After the 2nd evaluation, the treatment doses are determined by the investigators' clinical decision considering the severity of depression and tolerability of drug. Drugs are taken once daily per orally within 30 min after the supper meal.
12023104|NCT00419471|Drug|Placebo|Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
12023105|NCT00419458|Procedure|inspiratory muscle strength training|
12023106|NCT00419445|Drug|GTS21/Placebo|
12023107|NCT00419432|Other|Routine Observational Analysis (prior to procedure)|Controls will undergo the standard orthopaedic surgery using the information from the physical examination and observational analysis of the gait alone.
12023108|NCT00419432|Other|Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)|This experimental group will undergo standard orthopaedic surgery using the information from the physical examination, observational AND the gait laboratory analysis data
12023109|NCT00419419|Drug|Topical AmphiMatrix with nitroglycerin (MQX-503)|
12023110|NCT00419406|Procedure|UVA1 phototherapy|
12023111|NCT00419406|Procedure|NB-UVB phototherapy|
12023112|NCT00419393|Drug|Keppra XR (Levetiracetam XR)|500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
12023113|NCT00419380|Drug|dornase alfa (Pulmozyme®)|This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
12023114|NCT00419367|Drug|Comparator: vorinostat|Each patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal.
12023115|NCT00419341|Biological|Human Normal Immunoglobulin for Subcutaneous Administration|
12023116|NCT00419328|Drug|NGR-hTNF|iv q3W escalating dose up 1.6 mcg/sqm
12023117|NCT00419315|Behavioral|Alcohol Care Management|Care management for alcohol dependence with a focus on pharmacotherapy
12023118|NCT00419315|Behavioral|Usual Care|Usual care included a referral to a specialty addiction treatment program.
12023119|NCT00419302|Drug|Technosphere/Insulin|
12023120|NCT00419289|Behavioral|follow-up rehabilitation of participants with COPD|
12023121|NCT00419276|Procedure|Ambulatory continuous femoral nerve block for 100 hours|Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.
12023122|NCT00419263|Drug|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
12023123|NCT00419263|Drug|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
12023124|NCT00419263|Drug|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
12023125|NCT00419250|Drug|lenalidomide|
12023126|NCT00419250|Drug|lenalidomide|
12023127|NCT00419250|Drug|lenalidomide|
12023128|NCT00419250|Drug|lenalidomide|
12023129|NCT00419250|Drug|lenalidomide|
12023130|NCT00419237|Drug|GW685698X|GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.
12023131|NCT00419224|Biological|inactivated split-virus influenza vaccine|
12023132|NCT00419211|Behavioral|Exercise|Tailored exercise program
12023133|NCT00419198|Procedure|Postconditioning|Postconditioning during angioplasty
12023134|NCT00419198|Procedure|standard angioplasty|standard angioplasty without postconditioning
12023135|NCT00419185|Procedure|Delamination of the Internal limiting membrane|
12023136|NCT00419172|Drug|Deferasirox|
12023137|NCT00419172|Drug|Rifampicin|
12023138|NCT00419159|Drug|Everolimus (RAD001)|Everolimus was supplied in 5 mg tablets in blister packs.
12023139|NCT00419146|Drug|Ethyl-eicosapentaenoic acid (EPA)|Capsules, 2 g per day for 16 weeks
12023140|NCT00419146|Drug|Vitamins E + C|RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks
12023141|NCT00419146|Other|Etyl EPA (placebo)|Paraffin oil. Capsules, each 0.5 g.
12023142|NCT00419146|Other|Vitamins E+C (placebo)|Tablets containing dicalciumphosphate
12023143|NCT00419133|Biological|Killed bivalent whole cell oral cholera vaccine|"Each 1.5 mL dose, given orally, contains:
~V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS"
12023144|NCT00419133|Biological|Heat Killed E. coli Placebo|Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
12023145|NCT00419120|Biological|Autologous neo bladder construct|augmentation cystoplasty with autologous neo-bladder construct
12023146|NCT00419094|Drug|Keppra XR|Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
12023147|NCT00419094|Drug|Keppra XR|Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
12023148|NCT00419081|Drug|Forodesine Hydrochloride Sterile Solution, 5 mg/mL|
12023149|NCT00419081|Drug|Forodesine Hydrochloride Capsules (100 mg)|
12023150|NCT00419068|Drug|Cholecalciferol|
12023151|NCT00419068|Drug|Migliol Placebo Oil|
12023152|NCT00419055|Procedure|Early discharge after percutaneous coronary intervenntion|Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.
12023153|NCT00419042|Drug|TARCEVA|Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.
12023154|NCT00419042|Drug|Gemzar|GEMZAR by mixing it into a solution and giving it through a needle into a vein-called intravenous infusion (IV). This will take about 30 minutes
12023155|NCT00419029|Behavioral|telephone-administered motivational interviewing|telephone motivational interviewing
12023156|NCT00419029|Behavioral|control|brief telephone check-in (no motivational interviewing)
12023157|NCT00419003|Drug|Lamotrigine|anticonvulsant medication
12023158|NCT00419003|Drug|Ketamine|subanesthetic dose of NMDAR antagonist
12023159|NCT00419003|Drug|Riluzole|glutamate release inhibitor
12023160|NCT00418990|Drug|Multivitamin/Mineral supplements|
12023161|NCT00418977|Behavioral|"Family-Based Therapy (Maudsley Method)"|The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction.
12023162|NCT00418977|Behavioral|Individual Supportive Psychotherapy|The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment.
12023163|NCT00418964|Procedure|Single bundle hamstring|Single bundle hamstring
12023164|NCT00418964|Procedure|Double bundle hamstring|Double bundle hamstring
12023165|NCT00418964|Procedure|Bone patellar tendon bone|Bone patellar tendon bone
12023166|NCT00418951|Drug|Voriconazole|400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily
12023167|NCT00418951|Drug|Liposomal amphotericin B|3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes
12023168|NCT00418951|Drug|Liposomal amphotericin B|9 mg/kg intravenously once per week over 2 hours +/- 15 minutes
12023169|NCT00418938|Drug|Panitumumab|6mg/kg IV
12023170|NCT00418938|Drug|Bevacizumab|Either 5mg/kg OR 10mg/kg IV
12023171|NCT00418938|Drug|Leucovorin|400mg/m^2 IV (in the vein)
12023172|NCT00418938|Drug|Irinotecan|180mg/m^2 IV (in the vein)
12023173|NCT00418938|Drug|5-Fluorouracil|400mg/m^2 bolus IV (in the vein) over 2-4 min, followed by 2400mg/m^2 continuous IV over 46 hours for the first 2 cycles, increased to 3000mg/m^2 thereafter if no significant side effects
12023174|NCT00418925|Drug|Dronabinol|2.5 mg tablets; titrated over 14 days and 7 days steady dose
12023175|NCT00418899|Behavioral|Questionnaire|Questionnaire, 30-40 minutes, about gliomas and its risk factors (such as environmental and genetic information).
12023176|NCT00418886|Drug|Vandetanib|oral once daily tablet
12023177|NCT00418886|Drug|Pemetrexed|intravenous infusion
12023178|NCT00418873|Drug|Zotepine|Oral
12023179|NCT00418873|Drug|Risperidone|Oral
12023180|NCT00418860|Drug|Aspirin, Clopidogrel|Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure
12023181|NCT00418847|Drug|miglustat|Target dose of 320 mg/m^2/day (divided in 3 doses) will be based on the Body Surface Area (BSA). For children with a BSA > 1.3, 200 mg TID will be administered. For children with a BSA of 0.8-1.3, 100 mg TID will be administered.
12023182|NCT00418834|Drug|ezetimibe and atorvastatin|ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
12023183|NCT00418834|Drug|atorvastatin|Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
12023184|NCT00418834|Drug|Placebo (unspecified)|Placebo (unspecified) daily for 12 weeks
12023185|NCT00418821|Biological|Aldurazyme (laronidase)|dose of 0.58mg/kg body weight intravenously (IV) every week
12023186|NCT00418795|Drug|recombinant human porphobilinogen deaminase (Porphozym)|
12023187|NCT00418782|Drug|naproxen|
12023188|NCT00418782|Drug|CE-224535|
12023189|NCT00418782|Drug|placebo|
12023190|NCT00418769|Drug|Nilotinib|
12023191|NCT00418756|Drug|Nilotinib|Semi-synthetic antibiotic derivative of rifamycin B and is known to induce cytochrome P-450 (CYP) enzymes.
12023192|NCT00418730|Drug|tetrapeptide aldehyde proteasome inhibitor (NEOSH101)|Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
12023193|NCT00418717|Drug|etanercept|Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)
12023194|NCT00418704|Drug|Erlotinib|Tarceva (150 mg) is a pill you take once a day -- every day
12023195|NCT00418704|Drug|taxotere|Taxotere® (docetaxel) is given intravenously (I.V.) into the vein. Taxotere® chemotherapy treatment takes about one hour, and usually people receive treatments every three weeks.
12023196|NCT00418691|Drug|IR Methylphenidate|10 mg by mouth (PO) twice daily x 4 Weeks
12023197|NCT00418691|Drug|Modafinil|200 mg PO Once Daily x 4 Weeks
12023198|NCT00418691|Drug|SR Methylphenidate|18 mg PO Once Daily x 4 Weeks
12023199|NCT00418678|Drug|Cesamet|2 mg BID on Days 2-5.
12023200|NCT00418665|Biological|AMG 531|AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
12023201|NCT00418665|Drug|Placebo|Subjects in the control group will receive placebo via subcutaneous injection.
12023202|NCT00418652|Device|No TMS intervention|"In the no TMS condition, no simulation was given and no coil placed near participants' heads."
12023203|NCT00418652|Device|TMS over the PO3 EEG site|10Hz TMS over the dorsal stream (PO3 EEG site)
12023204|NCT00418652|Device|TMS over the vertex|10Hz TMS for over vertex.
12023205|NCT00418639|Drug|Nitazoxanide|
12023206|NCT00418626|Drug|Nilotinib|
12023207|NCT00418613|Drug|MK633|MK0633 100mg capsules qd for a 12-wk treatment period.
12023208|NCT00418613|Drug|Comparator: Placebo (unspecified)|MK0633 100mg Pbo capsules for a 12-wk treatment period
12023209|NCT00418600|Drug|Hectorol® (doxercalciferol capsules)|Hectorol capsules at 1.0 times current injection dose
12023210|NCT00418600|Drug|doxercalciferol capsules, Hectorol®|Hectorol capsules at 1.5 times current injection dose
12023211|NCT00418600|Drug|doxercalciferol capsules, Hectorol® capsules|Hectorol capsules at 2.0 times current injection dose
12023212|NCT00418587|Drug|Cholecalciferol|800 IU oral daily
12023213|NCT00418587|Drug|Cholecalciferol|2000 IU oral daily
12023214|NCT00418587|Drug|Cholecalciferol|4000 IU oral daily
12023215|NCT00418574|Biological|Abagovomab|2 mg/ml SC (subcutaneously)
12023216|NCT00418574|Biological|Placebo|2 mg/ml SC (subcutaneously)
12023217|NCT00418561|Drug|rhASA|intravenous infusion 25 U/kg,50 U/kg, 100U/kg or 200 U/kg every other week for 26 weeks
12023218|NCT00418548|Drug|Etanercept|
12023219|NCT00418535|Drug|Concurrent Radiotherapy (RT)/cisplatin, VIPD|
12023220|NCT00418522|Drug|Insulin glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
12023221|NCT00418522|Drug|Inhaled Insulin (Exubera)|Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
12023222|NCT00418509|Drug|Mometasone furoate|
12023223|NCT00418509|Drug|Formoterol fumarate|
12023224|NCT00418496|Drug|Aldesleukin|600,000 IU/kg every 8 hours on days 1-5 (week 1) to a maximum of 12 doses. Another cycle of HD aldesleukin will be started on day 15 (week 3).
12023225|NCT00418496|Drug|Sorafenib|To be initiated at a dose of 200 mg orally. Once it is determined that no further HD aldesleukin therapy will be given, sorafenib may be given daily at the FDA approved dose of 400 mg twice daily until there is lack of clinical benefit or intolerable side effects develop.
12023226|NCT00418483|Biological|Plasmin (Human) 25 mg|Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
12023227|NCT00418483|Biological|Plasmin (Human) 50 mg|Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
12023228|NCT00418483|Biological|Plasmin (Human) 75 mg|Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
12023229|NCT00418483|Biological|Plasmin (Human) 100 mg|Plasmin (Human) 100 mg
12023230|NCT00418483|Biological|Plasmin (Human) 125 mg|Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
12023231|NCT00418483|Biological|Plasmin (Human) 150 mg|Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
12023232|NCT00418483|Biological|Plasmin (Human) 175 mg|Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
12023233|NCT00418470|Procedure|regular dilution of antibiotic in NS|IV administration of ceftazidime tid diluted in regular NS volume
12023234|NCT00418470|Procedure|higher dilution of antibiotic in NS|IV administration of ceftazidime tid diluted in larger NS volume
12023235|NCT00418457|Drug|General anesthesia and opioids|General anesthesia, usually with sevoflurane, and opioid analgesia
12023236|NCT00418457|Drug|Regional analgesia and propofol|Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
12023237|NCT00418444|Behavioral|Group Therapy Intervention|
12023238|NCT00418431|Drug|Intravitreal injection of Bevacizumab|
12023239|NCT00418418|Procedure|Coronary bypass operation|Coronary bypass operation is performed via sternotomy during cardiac arrest.
12023240|NCT00418418|Procedure|Bone marrow aspiration (crista iliaca)|The bone marrow is aspirated from the iliac crest (100ml). During the operation the aspirate is transported to the stem cell laboratory, where the sample is centrifugated through Ficoll(Registered Trademark).
12023241|NCT00418418|Biological|Intramyocardial mesenchymal stem cell transplantation|During the cardiac arrest, stem cells are directly injected to myocardium. The amount of the cells varies individually (5-1000 x 10e6 cells), the cells are diluted in autologous serum (5 ml)
12023242|NCT00418418|Biological|Intramyocardial injection of autologous serum|Intramyocardial injection of autologous serum is injected during cardiac arrest
12023243|NCT00418392|Procedure|Simple aspiration with minocycline pleurodesis|Intrapleural instillation of 300mg minocycline within 5 min after simple aspiration
12023244|NCT00418392|Procedure|simple aspiration|Simple aspiration for primary spontaneous pneumothorax by pigtail catheter
12023245|NCT00418379|Drug|300 IR (4M)|300 IR grass pollen allergen extract tablet starting 4 months before the pollen season
12023246|NCT00418379|Drug|300 IR (2M)|300 IR grass pollen allergen extract tablet starting 2 months before the pollen season
12023247|NCT00418379|Drug|Placebo|Placebo tablet
12023248|NCT00418366|Drug|MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days|
12023249|NCT00418353|Drug|Betamethasone(Celestone soluspan) and Dexamethasone|
12023250|NCT00418340|Drug|probiotic (bacterial/dietary supplement)|
12023251|NCT00418327|Drug|Tarceva (Erlotinib Hydrochloride)|tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily
12023252|NCT00418314|Device|Control|Empiric programming or one-time optimization using a non-IEGM method.
12023253|NCT00418314|Device|QuickOpt|Frequent optimization using QuickOpt to optimize AV/PV and VV delays.
12023254|NCT00418301|Other|Precision Spinal Cord Stimulation and PET Scan|Imaging procedure to assess spinal Cord Stimulation.
12023255|NCT00418288|Drug|glucagon-like-peptide-1|intravenous infusion of 1.2pmol/kg/min for 7 hours
12023256|NCT00418288|Drug|placebo|intravenous infusion of 1.2pmol/kg/min
12023257|NCT00418275|Genetic|Recombinant Human Plasminogen Activator (HTUPA)|
12023258|NCT00418262|Drug|Atomoxetine|Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.
12023259|NCT00418249|Drug|AS101|
12023260|NCT00418210|Radiation|Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)|Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days
12023261|NCT00418197|Device|Total Facet Arthroplasty System® (TFAS®)|
12023262|NCT00418184|Dietary Supplement|Phosphatidylserine-Omega3|Phosphatidylserine-Omega3 conjugate capsules. Weeks 0-15: 300 mg/day. weeks 16-30: 150 mg/day and a 150 mg/day one year follow-up.
12023263|NCT00418184|Other|Colored cellulose tainted with fishy odor|as arm 1
12023264|NCT00418171|Drug|Ziprasidone|
12023265|NCT00418171|Drug|Olanzapine|
12023266|NCT00418158|Behavioral|use of Airlife (therapy)|
12023267|NCT00418145|Drug|megadose oral methylprednisolone|1400 mg qd/5 days
12023268|NCT00418145|Drug|IV methylprednisolone|1000 mg/qd/5 days
12023269|NCT00418132|Drug|Thalidomide|Thalidomide at a dose of 50 mg/day. The dose will be increased to 100 mg/day at Week 2, then to 200 mg/day at Week 4, and finally to 300 mg/day at Week 6.
12023270|NCT00418132|Drug|Placebo thalidomide|Participants will receive placebo thalidomide. The placebo dose will be increased through to Week 6.
12023271|NCT00418119|Drug|erythropoietin|
12023272|NCT00418093|Drug|Gemcitabine|Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
12023273|NCT00418093|Drug|Oxaliplatin|Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
12023274|NCT00418093|Drug|Bevacizumab|Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
12023275|NCT00418080|Drug|bicalutamide|
12023276|NCT00418067|Device|Endeavor|Zotarolimus-eluting stent
12023277|NCT00418067|Device|Cypher|Sirolimus-eluting stent
12023278|NCT00418067|Device|Taxus Liberte|Paclitaxel-eluting stent
12023279|NCT00418054|Drug|Nitazoxanide plus peginterferon alfa-2b|
12023280|NCT00418054|Drug|Peginterferon alfa-2b|
12023281|NCT00418028|Drug|Capecitabine|
12023282|NCT00418015|Procedure|Blood Draw|Blood for OPRM1 analysis
12023283|NCT00418002|Drug|AQW051|
12023284|NCT00417989|Device|MiniMed Paradigm REAL-Time System|Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter
12023285|NCT00417976|Drug|Gemcitabine|1000 mg/m2 over 100 minutes every 2 weeks.
12023286|NCT00417976|Drug|Bevacizumab|10 mg/kg every 2 weeks.
12023287|NCT00417976|Drug|Infusional 5-Fluorouracil|2400 mg/m2 over 48 hours every 2 weeks.
12023288|NCT00417963|Device|Carotid Artery Stenting|placement of a bare metal stent at sites of stenosis in the carotid artery
12023289|NCT00417950|Drug|Acarbose|
12023290|NCT00417937|Drug|azelaic acid 15% gel|15% gel, topically applied once daily for six weeks
12023291|NCT00417937|Drug|azelaic acid 15% gel|15% gel, topically applied twice daily for six weeks
12023292|NCT00417924|Behavioral|Patient education|
12023293|NCT00417911|Drug|bortezomib|Bortezomib 1,3 mg/sqm Days 1,4,8,11 for two 3-week cycles and then once a week for three weeks in 4 4-week cycles
12023294|NCT00417898|Drug|Aspirin|
12023295|NCT00417885|Drug|exemestane|25 mg, oral, daily dosing
12023296|NCT00417885|Drug|sunitinib malate|37.5 mg, oral, continuous dosing, daily
12023297|NCT00417872|Drug|Nitazoxanide|
12023298|NCT00417872|Drug|Metronidazole|
12023299|NCT00417859|Device|Total knee arthroplasty: mobile bearing|Total knee arthroplasty: mobile bearing
12023300|NCT00417833|Drug|Intravitreal Bevacizumab|
12023303|NCT00417794|Drug|Strattera|escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy
12023304|NCT00417794|Drug|Placebo|0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.
12023305|NCT00417768|Drug|Tissue Plasminogen Activator|The dosage of tPA is determined by the volume of drainage obtained when abscess is first drained. The same dose will be repeated on day 1 and 2.
12023306|NCT00417768|Other|Normal Saline|Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.
12023307|NCT00417742|Behavioral|Service delivery through a Headache Management Program|
12023308|NCT00417729|Drug|Acarbose|After an 8-week period of metformin monotherapy (500 mg t.i.d.), all patients were randomised to add on either acarbose or glibenclamide. The doses of acarbose and glibenclamide were 50 mg t.i.d. and 2.5 mg t.i.d., respectively, for 4 weeks and force-titrated to 100 mg t.i.d. and 5 mg t.i.d., respectively, for the last 12 weeks.
12023309|NCT00417716|Drug|Intravitreal Bevacizumab|
12023310|NCT00417690|Drug|4-Aminosalicylic acid|Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
12023311|NCT00417690|Drug|PASER placebo granules|Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks
12023312|NCT00417677|Drug|Combination of Temsirolimus and Sunitinib|
12023313|NCT00417664|Drug|dexmedetomidine|
12023314|NCT00417664|Drug|midazolam|
12023315|NCT00417664|Drug|propofol|
12023316|NCT00417638|Device|Endovascular cooling by the Celsius Control System|
12023317|NCT00417638|Other|Standard of care|
12023318|NCT00417612|Drug|Paricalcitol|Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits.
12023319|NCT00417612|Other|Placebo|Placebo sugar pill
12023320|NCT00417599|Behavioral|Lifestyle Intervention|lifestyle intervention .
12023321|NCT00417599|Other|control group|waiting list control group
12023322|NCT00417586|Device|Specialized Doppler Ultrasound Instrument|Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening
12023323|NCT00417573|Drug|IV Gamunex 10%|
12023324|NCT00417560|Biological|inactivated influenza A/H5N1 vaccine|
12023325|NCT00417521|Behavioral|Family-Based Treatment|
12023326|NCT00417508|Dietary Supplement|Sip feeding|Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
12023327|NCT00417508|Dietary Supplement|Dietary Advice|The patients will receive ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and no daily sip feeding supplements.
12023328|NCT00417495|Behavioral|Sentinel Lymph Node Technique|
12023329|NCT00417482|Drug|risperidone|Risperidone open label flexible dose 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for randomized trial
12023330|NCT00417469|Device|NADGL|
12023331|NCT00417456|Other|Evisit|Asynchronous,remote care delivery via a secure web platform
12023332|NCT00417456|Other|Office visit|Conventional office-based care
12023333|NCT00417443|Drug|Clonidine|
12023334|NCT00417430|Drug|ICI 182,780 (Faslodex)|
12023335|NCT00417417|Drug|Rilonacept|Lyophilized rilonacept will be supplied by Regeneron Pharmaceuticals at 160 mg/vial and reconstituted with 2.3 mL of sterile water for injection by the Clinical Center Pharmacy Intravenous Admixture Unit. The formulation contains 80 mg/mL rilonacept, histidine, citrate, PEG 3350, polysorbate 20, glycine, arginine, and sucrose (pH 6.5). Matching placebo in the identical formulation will also be supplied, and also reconstituted with 2.3 mL of sterile water for injection. Each administration of study drug will consist of two syringes containing 2.0 mL in each syringe (320 mg total drug).
12023336|NCT00417417|Drug|Placebo|Normal saline subcutaneously at each treatment visit.
12023337|NCT00417404|Drug|Aquasol A|IM Aquasol A 10,000IU three times weekly
12023338|NCT00417404|Drug|aquasol A|10,000 IU three times weeks, by intramuscular injection
12023339|NCT00417404|Other|sham injection|sham injection
12023340|NCT00417391|Drug|RR110 (Tamibarotene)|1 mg RR110
12023341|NCT00417391|Drug|RR110 (Tamibarotene)|4 mg RR110
12023342|NCT00417378|Device|Left Ventricular Assist Device Impella LP 2.5|Left Ventricular Assist Device
12023343|NCT00417378|Device|Intraaortic Balloon Pump|Counterpulsation
12023344|NCT00417365|Device|WaterWorks Douching Device|
12023345|NCT00417352|Device|Brace|
12023346|NCT00417352|Device|Added mass|
12023347|NCT00417339|Procedure|hemodialysis|individualised
12023348|NCT00417326|Drug|ONO-5046Na|twenty four hour infusion at 0 mg/kg/hr for 14 days
12023349|NCT00417326|Drug|ONO-5046Na|twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days
12023350|NCT00417313|Device|periosteal electro-acupuncture (osteopuncture).|
12023351|NCT00417287|Drug|PX-12|3 hour intravenous infusion as a dose of either 54 mg/m2 or 128 mg/m2 daily for 5 days every three weeks.
12023352|NCT00417274|Drug|Quinacrine|100 mg daily
12023353|NCT00417261|Drug|ATF936|
12023354|NCT00417261|Drug|AXT914|
12023355|NCT00417248|Drug|Cisplatin|Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
12023356|NCT00417248|Drug|Etoposide|Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
12023357|NCT00417248|Procedure|Radiotherapy|Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
12023358|NCT00417248|Drug|Sorafenib|Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
12023359|NCT00417235|Device|Chlorhexidine Sponge (Biopatch TM)|dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
12023360|NCT00417235|Behavioral|7-day catheter dressing frequency|dressing changes every 7 days versus every classical change every 3 days
12023361|NCT00417222|Drug|olmesartan medoxomil|5 to 40mg P.O. daily until the end of the study
12023362|NCT00417209|Drug|Larotaxel (XRP9881)|administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
12023363|NCT00417209|Drug|5-Fluorouracil|administered as IV infusion from Day 1 to Day 4
12023364|NCT00417209|Drug|Capecitabine|administered orally from Day 1 to Day 14 q3w
12023365|NCT00417196|Drug|QAX576|
12023366|NCT00417183|Drug|Arvekap 0.1 mg (Triptorelin, Ipsen, France)|
12023367|NCT00417183|Drug|Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)|
12023368|NCT00417170|Drug|Aliskiren|Aliskiren 300 mg tablets taken orally once daily
12023369|NCT00417170|Drug|Amlodipine|Amlodipine 5 mg capsule taken orally once daily
12023370|NCT00417170|Drug|Placebo Aliskiren|Placebo Aliskiren taken orally once daily.
12023371|NCT00417170|Drug|Placebo Amlodipine|Placebo Amlodipine taken orally once daily
12023372|NCT00417157|Drug|recombinant FSH (Puregon, Organon, The Netherlands)|
12023373|NCT00417157|Drug|GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)|
12023374|NCT00417157|Drug|hCG (Pregnyl, Organon, The Netherlands)|
12023375|NCT00417144|Drug|Arvekap 0.1mg (Triptorelin, Ipsen, France)|
12023376|NCT00417144|Drug|Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)|
12023377|NCT00417118|Drug|Saredutant|oral administration (capsules)
12023378|NCT00417118|Drug|Escitalopram|oral administration (capsules)
12023379|NCT00417118|Drug|Placebo|oral administration (capsules)
12023380|NCT00417105|Procedure|hemodialysis|group 1: twice weekly, four hours
12023381|NCT00417105|Procedure|hemodialysis|group 2: twice weekly, eight hours
12023382|NCT00417105|Procedure|hemodialysis|group 3: every other day, eight hours
12023383|NCT00417105|Procedure|hemodialysis|group 4: six days a week, eight hours
12023384|NCT00417092|Procedure|Postoperative Pacing|
12023385|NCT00417079|Drug|cabazitaxel (XRP6258) (RPR116258)|25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
12023386|NCT00417079|Drug|mitoxantrone|12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle
12023387|NCT00417079|Drug|prednisone|10 mg daily administered by oral route
12023388|NCT00417066|Drug|Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)|
12023389|NCT00417066|Drug|Arvekap 0.1mg (Triptorelin, Ipsen, France)|
12023390|NCT00417053|Biological|filgrastim|
12023391|NCT00417053|Drug|busulfan|
12023392|NCT00417053|Drug|carboplatin|
12023393|NCT00417053|Drug|cyclophosphamide|
12023394|NCT00417053|Drug|doxorubicin hydrochloride|
12023395|NCT00417053|Drug|etoposide phosphate|
12023396|NCT00417053|Drug|melphalan|
12023397|NCT00417053|Drug|vincristine sulfate|
12023398|NCT00417053|Procedure|autologous bone marrow transplantation|
12023399|NCT00417053|Procedure|bone marrow ablation with stem cell support|
12023400|NCT00417053|Procedure|conventional surgery|
12023401|NCT00417053|Procedure|peripheral blood stem cell transplantation|
12023402|NCT00417053|Radiation|radiation therapy|
12023403|NCT00417040|Other|internet-based intervention|Use the STAR database system
12023404|NCT00417040|Other|assessment of therapy complications|Use the STAR database system
12023405|NCT00417040|Other|Questionnaire Administration|Ancillary studies
12023406|NCT00417027|Procedure|Programmed Intermittent Epidural Bolus (PIEB)|A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes.
12023407|NCT00417014|Drug|chlorambucil|
12023408|NCT00417014|Drug|prednisolone|
12023409|NCT00417014|Drug|procarbazine hydrochloride|
12023410|NCT00417014|Drug|vinblastine sulfate|
12023411|NCT00417014|Radiation|radiation therapy|
12023412|NCT00417001|Procedure|Aroma therapy|
12023413|NCT00416988|Other|educational intervention|
12023414|NCT00416975|Other|counseling intervention|Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
12023415|NCT00416975|Other|educational intervention|Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
12023416|NCT00416975|Procedure|evaluation of cancer risk factors|Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
12023417|NCT00416962|Drug|amantadine hydrochloride|
12023418|NCT00416962|Drug|oseltamivir phosphate|
12023419|NCT00416949|Device|Patient-specific dosimetry|Patient-specific 3D-RD dosimetry was applied to the data collected
12023420|NCT00416923|Biological|rituximab|
12023421|NCT00416910|Biological|Filgrastim|
12023427|NCT00416897|Procedure|plasmapheresis|
12023428|NCT00416884|Drug|Campath|30 mg on day -8 over 5-6 hours
12023429|NCT00416884|Drug|Fludarabine|Fludarabine 30 mg/m^2 on day -4 through day -2
12023430|NCT00416884|Radiation|Total Body Irradiation (TBI)|Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0
12023431|NCT00416884|Other|T-Cell Deplete|Stem cells will be T cell depleted and given on day 0
12023432|NCT00416871|Biological|aldesleukin|
12023433|NCT00416871|Biological|recombinant interferon alfa|
12023434|NCT00416858|Drug|cisplatin|
12023435|NCT00416858|Drug|fluorouracil|
12023436|NCT00416858|Procedure|adjuvant therapy|
12023437|NCT00416858|Procedure|conventional surgery|
12023438|NCT00416858|Procedure|neoadjuvant therapy|
12023439|NCT00416858|Radiation|radiation therapy|
12023440|NCT00416845|Drug|FTY720|
12023441|NCT00416832|Drug|cyclophosphamide|
12023442|NCT00416832|Drug|dacarbazine|
12023443|NCT00416832|Drug|doxorubicin hydrochloride|
12023444|NCT00416832|Drug|etoposide|
12023445|NCT00416832|Drug|prednisone|
12023446|NCT00416832|Drug|procarbazine hydrochloride|
12023447|NCT00416832|Drug|vincristine sulfate|
12023448|NCT00416832|Radiation|radiation therapy|
12023449|NCT00416819|Biological|filgrastim|
12023450|NCT00416819|Biological|rituximab|
12023451|NCT00416819|Drug|cytarabine|
12023452|NCT00416819|Drug|etoposide phosphate|
12023453|NCT00416819|Drug|leucovorin calcium|
12023454|NCT00416819|Drug|methotrexate|
12023455|NCT00416819|Drug|temozolomide|
12023456|NCT00416793|Drug|bortezomib|Given IV
12023457|NCT00416793|Drug|carboplatin|Given IV
12023458|NCT00416793|Other|laboratory biomarker analysis|Correlative studies
12023459|NCT00416780|Other|counseling intervention|
12023460|NCT00416780|Other|educational intervention|
12023461|NCT00416780|Procedure|psychosocial assessment and care|
12023462|NCT00416767|Drug|fluorouracil|
12023463|NCT00416767|Drug|irinotecan hydrochloride|
12023464|NCT00416767|Drug|leucovorin calcium|
12023465|NCT00416754|Other|counseling intervention|subjects will receive genetic counseling
12023466|NCT00416741|Behavioral|Implementation of guidelines|Attaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose
12023467|NCT00416728|Drug|Aliskiren|
12023468|NCT00416728|Drug|Valsartan|
12023469|NCT00416715|Drug|letrozole|Given PO
12023470|NCT00416715|Dietary Supplement|calcium carbonate|Given PO
12023471|NCT00416715|Other|laboratory biomarker analysis|Optional correlative studies
12023472|NCT00416715|Dietary Supplement|calcium citrate|Given PO
12023473|NCT00416715|Dietary Supplement|calcium glucarate|Given PO
12023474|NCT00416715|Drug|calcium gluconate|Given PO
12023475|NCT00416715|Dietary Supplement|cholecalciferol|Given PO
12023476|NCT00416715|Procedure|assessment of therapy complications|Ancillary studies
12023477|NCT00416715|Procedure|musculoskeletal complications management/prevention|Correlative studies
12023478|NCT00416702|Drug|QAB149|
12023479|NCT00416689|Procedure|assessment of therapy complications|
12023480|NCT00416689|Procedure|quality-of-life assessment|
12023481|NCT00416676|Drug|carboplatin|
12023482|NCT00416676|Drug|cisplatin|
12023483|NCT00416676|Drug|cyclophosphamide|
12023484|NCT00416676|Drug|etoposide|
12023485|NCT00416676|Drug|vincristine sulfate|
12023486|NCT00416676|Procedure|adjuvant therapy|
12023487|NCT00416676|Procedure|conventional surgery|
12023488|NCT00416676|Procedure|neoadjuvant therapy|
12023489|NCT00416676|Radiation|radiation therapy|
12023490|NCT00416663|Procedure|Intracoronary administration of autologous ACPs|Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment
12023491|NCT00416650|Drug|erlotinib hydrochloride|All patients will receive 150 mg orally daily
12023492|NCT00416637|Biological|Bevacizumab (Avastin)|
12023493|NCT00416624|Drug|darbepoetin alfa|
12023494|NCT00416624|Drug|epoetin alfa|
12023495|NCT00416624|Procedure|fatigue assessment and management|
12023496|NCT00416624|Procedure|quality-of-life assessment|
12023497|NCT00416611|Behavioral|Implementation of guidelines|
12023498|NCT00416598|Procedure|Autologous Bone Marrow Transplantation|Undergo autologous bone marrow transplantation
12023499|NCT00416598|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSC transplantation
12023500|NCT00416598|Drug|Busulfan|Given IV
12023501|NCT00416598|Drug|Cytarabine|Given IV
12023502|NCT00416598|Drug|Daunorubicin Hydrochloride|Given IV
12023503|NCT00416598|Drug|Decitabine|Given IV
12023504|NCT00416598|Drug|Etoposide|Given IV
12023505|NCT00416598|Biological|Filgrastim|Given SC
12023506|NCT00416598|Other|Laboratory Biomarker Analysis|Correlative studies
12023507|NCT00416598|Other|Pharmacological Study|Correlative studies
12023508|NCT00416585|Drug|isotretinoin (Roaccutane)|
12023509|NCT00416572|Behavioral|Education Intervention|Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer and how to create a safe environment for them; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read.
12023574|NCT00416182|Drug|Placebo|2.5 mL of placebo delivered via Sinustar nebulizer device
12023575|NCT00416169|Drug|galantamine hydrobromide|
12023576|NCT00416156|Behavioral|Lifestyle modification|
12023577|NCT00416143|Procedure|bed rest|
12023510|NCT00416572|Behavioral|Nutrition Education Intervention|The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it.
12023511|NCT00416559|Other|clinical observation|
12023512|NCT00416546|Drug|AEB071|
12023513|NCT00416533|Drug|docetaxel|
12023514|NCT00416533|Drug|doxorubicin hydrochloride|
12023515|NCT00416533|Drug|prednisone|
12023516|NCT00416520|Drug|MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
12023517|NCT00416520|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
12023518|NCT00416520|Drug|Another phosphate binder (Sevelamer)|Current approved dosing recommendations for 12 weeks
12023519|NCT00416507|Drug|fluorouracil|
12023520|NCT00416507|Drug|gemcitabine hydrochloride|
12023521|NCT00416507|Drug|liposomal cisplatin|
12023522|NCT00416494|Biological|bevacizumab|10 mg/kg intravenously over 30-90 minutes on day 1
12023523|NCT00416494|Drug|oxaliplatin|85 mg/m2 intravenously over 2 hours on day 1.
12023524|NCT00416494|Drug|Capecitabine|Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
12023525|NCT00416494|Drug|Capecitabine|Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
12023526|NCT00416481|Behavioral|quality of life questionnaires|
12023527|NCT00416468|Drug|Aliskiren|
12023528|NCT00416468|Drug|Valsartan|
12023529|NCT00416455|Radiation|fludeoxyglucose F 18|Undergo FDG PET/CT
12023530|NCT00416455|Procedure|positron emission tomography|Undergo FDG PET/CT
12023531|NCT00416455|Procedure|computed tomography|Undergo FDG PET/CT
12023532|NCT00416455|Drug|ferumoxtran-10|Undergo femoxtran-10 MRI
12023533|NCT00416455|Procedure|magnetic resonance imaging|Undergo femoxtran-10 MRI
12023534|NCT00416455|Procedure|diagnostic lymphadenectomy|Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
12023535|NCT00416455|Procedure|lymph node biopsy|Undergo pelvic and abdominal lymph node biopsy
12023536|NCT00416442|Drug|RSV604|
12023537|NCT00416429|Biological|aldesleukin|
12023538|NCT00416429|Biological|recombinant interferon alpha-2a|
12023539|NCT00416429|Drug|medroxyprogesterone|
12023540|NCT00416403|Drug|fluvastatin sodium|Given orally
12023541|NCT00416403|Procedure|Breast Cancer Surgery Only - Arm III|Breast Cancer Surgery
12023542|NCT00416390|Dietary Supplement|lycopene|
12023543|NCT00416390|Other|laboratory biomarker analysis|
12023544|NCT00416390|Procedure|biopsy|
12023545|NCT00416377|Biological|bleomycin sulfate|
12023546|NCT00416377|Drug|chlorambucil|
12023547|NCT00416377|Drug|dacarbazine|
12023548|NCT00416377|Drug|doxorubicin hydrochloride|
12023549|NCT00416377|Drug|prednisolone|
12023550|NCT00416377|Drug|procarbazine hydrochloride|
12023551|NCT00416377|Drug|vinblastine sulfate|
12023552|NCT00416377|Drug|vincristine sulfate|
12023553|NCT00416377|Radiation|radiation therapy|
12023554|NCT00416351|Drug|clofarabine|
12023555|NCT00416338|Device|film dressing by adhesive|
12023556|NCT00416325|Dietary Supplement|lycopene|
12023557|NCT00416325|Other|laboratory biomarker analysis|
12023558|NCT00416312|Device|Patient-specific dosimetry|"Tumor absorbed dose calculation using patient-specific 3D-RD dosimetry software.
~Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I tositumomab IV over 20 minutes on approximately day 7."
12023559|NCT00416312|Device|conventional dosimetry|"Doses calculated using conventional dosimetry software.
~Patients receive dosimetric rituximab IV followed by indium In 111 (^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9."
12023560|NCT00416273|Drug|Bortezomib|Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.
12023561|NCT00416273|Drug|No intervention|Participants in the observation group will be observed and will not receive any consolidation therapy.
12023562|NCT00416260|Other|High Frequency Oscillation and Tracheal Gas Insufflation|Intermittent combined use of High Frequency Oscillation and Tracheal Gas Insufflation until the PaO2/inspired oxygen fraction ratio remains above than 150 mm Hg for more than 24 hours.
12023563|NCT00416247|Behavioral|Hypnosis|Hypnosis
12023564|NCT00416234|Procedure|Laparoendoscopic Rendez vous|intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
12023565|NCT00416234|Procedure|preoperative ERCP and CBD clearance|ERCP and CBD clearance followed by laparoscopic cholecystectomy
12023566|NCT00416221|Drug|Lexapro, an antidepressant medicine|
12023567|NCT00416221|Behavioral|Physical Activity|
12023568|NCT00416221|Behavioral|Mood Management Skills|
12023569|NCT00416221|Behavioral|Personalized support from a Family Nurse Practitioner|
12023570|NCT00416208|Drug|Bortezomib|1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
12023571|NCT00416195|Drug|E2007|
12023572|NCT00416195|Drug|Placebo|
12023573|NCT00416182|Drug|Pulmozyme (dornase alfa)|2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
12023616|NCT00415805|Drug|vasovist|0.25 molar single injection 0.03 ml/kg
12023578|NCT00416143|Drug|prednisone - oral corticosteroid 1mg/kg/D for 1 week|
12023579|NCT00416130|Drug|Vorinostat|MK-0683 capsules, 100 mg, 400mg once a day, continuously (at dose level 0 - Phase 1 part of the study)
12023580|NCT00416117|Procedure|Manual Physical Therapy and Exercise|
12023581|NCT00416117|Procedure|Minimal Intervention|
12023582|NCT00416078|Behavioral|caregiver website support|caregiver access to website support for 6 months embedded in one year of customary care
12023583|NCT00416078|Behavioral|caregiver brief supportive phone calls|caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
12023584|NCT00416065|Device|PET/CT imaging|
12023585|NCT00416039|Drug|Midazolam|0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
12023586|NCT00416039|Drug|Placebo|placebo at 0.2 mg/kg and morphine 0.5 mg/kg
12023587|NCT00416026|Behavioral|Educational/Counseling/Training|
12023588|NCT00415987|Procedure|Hematopoietic Stem Cell Transplantation|
12023589|NCT00415974|Behavioral|Physician Counseling|Physician-patient visits will occur in the primary care setting and are scheduled at study onset (beginning of step 1) and at the end of the first year. An extra physician visit will occur for patients who do not progress from step 1 after two attempts. At study entry, physicians will discuss the purpose and importance of the intervention and encourage participation. Physicians will underline the value of attending all study visits and complying with study protocol and instructions. Subsequent physician visits will focus on weight loss progress and overcoming barriers.
12023590|NCT00415974|Behavioral|Health Educator|Health education sessions are held with teens and parents at the primary care setting. These include information on nutrition, physical activity, and weight loss. Behavioral approaches are used to enhance the home environment, food preparation, and planned physical activity to elicit weight loss, including discovery of perceived and actual barriers to modification of eating and physical activity behaviors. The Health Educator focuses on problem-solving and tailored selection of behavior change skills to help participants overcome difficulties. In addition to reviewing the assessment and generating solutions to barriers, sample meal plans (including strategies for restricting calories) and pedometers will be distributed at the initial health educator visit. Pedometers are encouraged to monitor progress with physical activity goals. An initial binder is distributed to teen and parent participants at the initial session and subsequent materials are added with each visit.
12023591|NCT00415974|Behavioral|Phone Counseling|Brief counseling calls will occur between PACE-PC participants and assigned counselors during all steps. In general, these calls occur on a bi-weekly to monthly basis in steps 1 and 2, and monthly in step 3. Such calls are intended to encourage continued goal attainment and progression and to promote healthy eating and physical activity behaviors. Counselors will review progress since the last clinical interaction (e.g., health educator visit, phone call, or physician visit) and help adolescents set new goals that are appropriate and attainable. Data from pedometers may be discussed during these sessions as an interim assessment of progress on physical activity behaviors between formal study measurement visits. After speaking with the adolescent, the counselor will talk with the parent (when feasible) to reinforce parental involvement and emphasize the importance of the healthy changes in the home environment to encourage goal attainment.
12023592|NCT00415974|Behavioral|Health promotion materials on physical activity and nutrition|PACE-PC adolescents and their families will receive information regarding healthy eating and physical activity behaviors on a weekly basis via mail. These behavioral-based materials will educate participants and their families on healthy behaviors that are necessary for successful weight management. Topics will coincide with the intervention goals and include supplemental information to enhance quality of life and improve body image. Topics will include realistic goal-setting and attainment, how to handle holidays and celebrations, eating fast food, grocery shopping and food preparation, and relapse prevention, etc.. Topics will include specific strategies related to the adolescent's readiness to change to reflect processes that are most appropriate. Content from these materials will be addressed by the phone counselors to ensure that participants received and understood intervention messages.
12023593|NCT00415961|Device|CoStar Paclitaxel Drug-Eluting Coronary Stent System|CoStar Paclitaxel Drug-Eluting Coronary Stent System
12023594|NCT00415948|Device|Biomarkers|
12023595|NCT00415935|Drug|methotrexate|
12023596|NCT00415922|Drug|ELC200 (carbidopa+levodopa+entacapone)|
12023597|NCT00415909|Drug|Imatinib Mesylate (IM)|IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.
12023598|NCT00415909|Drug|TALL-104 cells|TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
12023599|NCT00415896|Device|positive pressure ventilation|
12023600|NCT00415883|Drug|Valsartan|
12023601|NCT00415870|Behavioral|Printed Material|Printed Material
12023602|NCT00415870|Behavioral|Weekly Weighing|Weekly Weighing
12023603|NCT00415870|Behavioral|Cell phone will serve as a self monitoring device|Cell phone will serve as a self monitoring device
12023604|NCT00415870|Device|Text Message|Text Message
12023605|NCT00415870|Behavioral|Diet Goals via Cell Phone|Diet Goals via Cell Phone
12023606|NCT00415870|Behavioral|Food Monitoring|Food Monitoring
12023607|NCT00415857|Biological|Peptide Vaccine (PR1 Peptide)|PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses.
12023608|NCT00415857|Drug|Peginterferon alfa-2b|Subcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination.
12023609|NCT00415857|Drug|Imatinib|Continue receiving imatinib by mouth at the same dose received during the last 6 months.
12023610|NCT00415857|Drug|GM-CSF|75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
12023611|NCT00415844|Drug|ELC200 (carbidopa+levodopa+entacapone)|
12023612|NCT00415831|Drug|ELC200 (carbidopa+levodopa+entacapone)|
12023613|NCT00415818|Biological|MVA-MUC1-IL2|"MVA-MUC1-IL2:
~Dose of 10exp8 plaque forming units (pfu).
~Chemotherapy:
~Arm 1 and Arm 2 Intravenous CT: cisplatin (75mg/m² at Day 1) and gemcitabine (1250mg/m² at Days 1 and 8) every 3 weeks, for up to six cycles or until progressive disease, whichever occurred first."
12023614|NCT00415818|Drug|1st line Chemotherapy|
12023615|NCT00415805|Drug|Multihance|0.5 Molar, single injection at 0.2 mL/kg
12023618|NCT00415779|Drug|docetaxel|given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
12023619|NCT00415779|Drug|zoledronic acid|2 mg IV every 2 weeks
12023620|NCT00415766|Drug|rHCG 250ug|Injection of 250 ug Ovitrelle to trigger final oocyte maturation
12023621|NCT00415766|Drug|uHCG 5000 IU|Injection of 5000 IU Pregnyl to trigger final oocyte maturation
12023622|NCT00415766|Drug|uHCG 7500 IU|Injection of 7500 IU Pregnyl to trigger final oocyte maturation
12023623|NCT00415753|Behavioral|No antibiotics if se-procalcitonin is below stated limit|
12023624|NCT00415740|Drug|ELC200 (carbidopa+levodopa+entacapone)|
12023625|NCT00415727|Device|auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation|
12023626|NCT00415714|Device|Portable Biofeedback|
12023627|NCT00415701|Drug|Etomidate|Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg
12023628|NCT00415701|Drug|Propofol|Single induction dose of propofol 2%; total dose 1.5 mg/kg
12023629|NCT00415701|Drug|Hydrocortisone|Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x
12023630|NCT00415701|Drug|NaCl 0.9%|NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x
12023631|NCT00415701|Other|Tetracosactin|Diagnostic test, Tetracosactin 250 microg iv
12023632|NCT00415688|Behavioral|Low carbohydrate, ketogenic diet|
12023633|NCT00415688|Behavioral|Low glycemic index, reduced calorie diet|
12023634|NCT00415675|Procedure|Motion CT Scans|A total of up to 12 scanning sessions used to understand how the tumor and other organs move while breathing.
12023635|NCT00415662|Device|Pulsed Signal Therapy (PST)|
12023636|NCT00415649|Biological|VRC-HIVDNA016-00-VP|
12023637|NCT00415649|Biological|VRC-HIVADV014-00-VP|
12023638|NCT00415649|Biological|Vaccine placebo|Placebo comparator
12023639|NCT00415636|Drug|IC83/LY2603618|40 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m^2.
12023640|NCT00415636|Drug|IC83/LY2603618|70 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
12023641|NCT00415636|Drug|IC83/LY2603618|105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
12023642|NCT00415636|Drug|IC83/LY2603618|150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
12023643|NCT00415636|Drug|IC83/LY2603618|195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
12023644|NCT00415636|Drug|pemetrexed|pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
12023645|NCT00415636|Drug|pemetrexed|pemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
12023646|NCT00415623|Drug|Amlodipine|Amlodipine 5mg/ day
12023647|NCT00415623|Drug|Amlodipine|Amlodipine 10mg/ day
12023648|NCT00415610|Drug|nicardipine|"Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
~Started at 5mg/h
~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
12023649|NCT00415597|Drug|ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)|capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily
12023650|NCT00415584|Drug|Cinacalcet HCl|
12023651|NCT00415571|Drug|Fispemifene (once daily for 8 weeks)|
12023652|NCT00415558|Device|Microwave Ablation System|
12023653|NCT00415545|Behavioral|Fluid Watchers LITE Educational Intervention|Patients in Fluid Watchers LITE will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written material, a diary, a scale and a telephone follow-up to answer any questions they might have about the educational session.
12023654|NCT00415545|Behavioral|Fluid Watchers PLUS Educational Intervention|Patients in Fluid Watchers PLUS will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written materials, a diary, a scale, an audio tape of the session and telephone followup. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis, as compared to participants in the LITE program.
12023655|NCT00415532|Drug|Medical Standard of Care for ITP|
12023656|NCT00415532|Biological|Romiplostim|
12023657|NCT00415519|Drug|MCI-186|Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
12023658|NCT00415519|Drug|Placebo of MCI-186|Two ampoules of Placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
12023659|NCT00415506|Drug|Rituximab|Two 500 or 1000mg infusions over 2 weeks with the option of retreating after 6 months if initial improvement was seen.
12023660|NCT00415493|Other|Cold-dry air provocation|15 minute exposure to cold-dry air by nasal mask
12023661|NCT00415493|Other|Warm-moist air provocation|15 minute exposure to warm-moist air by nasal mask
12023662|NCT00415467|Device|GliaSite Radiation Therapy System|Radiation delivery system that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.
12023663|NCT00415454|Genetic|Ad5-yCD/mutTKSR39rep-ADP|Single injection on day 1 at one of five dose levels
12023664|NCT00415441|Procedure|Physiotherapy program|
12023665|NCT00415441|Procedure|Placebo physiotherapy treatment|
12023666|NCT00415428|Behavioral|Patient adherence to national educational guidelines.|
12023667|NCT00415402|Drug|Vitamin D3|
12023668|NCT00415389|Behavioral|interactive educational program|2-session interactive stroke educational program
12023669|NCT00415389|Behavioral|usual medical care|standard educational materials and usual care
12023670|NCT00415376|Drug|levetiracetam|
12023671|NCT00415376|Procedure|quality-of-life assessment|
12023672|NCT00415363|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until disease progression
12023673|NCT00415363|Drug|placebo|oral, daily
12023674|NCT00415350|Drug|Azithromycin|Azithromycin Tablet 250 mg daily
12023675|NCT00415350|Other|Placebo|Placebo tablet 1 daily
12023676|NCT00415337|Procedure|endobronchial ultrasound|EBUS
12023677|NCT00415324|Drug|eribulin mesylate|Given IV
12023678|NCT00415324|Drug|cisplatin|Given IV
12023679|NCT00415324|Other|laboratory biomarker analysis|correlative study
12023680|NCT00415324|Other|pharmacological study|correlative study
12023681|NCT00415311|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous(i.v.) administration for 8 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12023682|NCT00415311|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous(i.v.) administration for 8 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12023683|NCT00415311|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous(i.v.) administration for 8 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12023684|NCT00415298|Drug|DACH polymer platinate AP5346|
12023685|NCT00415298|Drug|oxaliplatin|
12023686|NCT00415298|Genetic|gene expression analysis|
12023687|NCT00415298|Other|immunohistochemistry staining method|
12023688|NCT00415298|Other|pharmacological study|
12023689|NCT00415298|Procedure|biopsy|
12023690|NCT00415285|Drug|Docetaxel|
12023691|NCT00415285|Drug|Capecitabine|
12023692|NCT00415285|Drug|Docetaxel/Capecitabine|
12023693|NCT00415272|Behavioral|Pulmonary Rehabilitation|
12023694|NCT00415259|Device|Laterally wedged shoe insoles|Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
12023695|NCT00415259|Device|Control insole group|Flat control insoles worn inside the shoes daily for 12 months
12023696|NCT00415246|Drug|Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)|
12023697|NCT00415233|Biological|recombinant thyroid-stimulating hormone|Recombinant thyroid stimulating hormone (rhTSH) should be given at a dose of 0.9mg by intramuscular injection on two consecutive days before ablation.
12023698|NCT00415233|Radiation|Radiodine ablation without rhTSH|Patients in this group do not receive rhTSH pre ablation.
12023699|NCT00415220|Procedure|Spinal Manipulation, Microdiscectomy|
12023700|NCT00415194|Drug|pemetrexed|500 mg/m^2, IV, every 21 days, six 21 day cycles
12023701|NCT00415194|Drug|cisplatin|75 mg/m^2, administered IV, every 21 days, six 21 day cycles
12023702|NCT00415194|Drug|placebo|Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
12023703|NCT00415168|Drug|pemetrexed|700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles
12023704|NCT00415168|Drug|cisplatin|75 mg/m2, IV, every 21 days x 6 cycles
12023705|NCT00415155|Drug|LY2181308|"Phase 1: 250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. (dose escalation)
~Phase 2: phase 1 recommended dose, maximum 750mg dose, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle."
12023706|NCT00415142|Drug|saredutant (SR48968)|oral administration (capsules)
12023707|NCT00415142|Drug|placebo|oral administration (capsules)
12023708|NCT00415142|Drug|escitalopram|oral administration (capsules)
12023709|NCT00415129|Biological|A/H5N1 inactivated, split-virion influenza virus|0.5mL, Intramuscular
12023710|NCT00415129|Biological|A/H5N1 inactivated, split-virion influenza virus|0.5mL, Intramuscular
12023711|NCT00415116|Drug|carboplatin|
12023712|NCT00415116|Drug|docetaxel|
12023713|NCT00415116|Drug|lenalidomide|
12023714|NCT00415103|Drug|Aprepitant|Aprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days
12023715|NCT00415103|Drug|Palonosetron|Palonosetrón: 0.25 mg iv every 48 hours, starting day 1
12023716|NCT00415103|Drug|Granisetron|Granisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment
12023717|NCT00415090|Drug|Nevirapine|Switch one of ARV drugs to Nevirapine
12023718|NCT00415077|Procedure|PRK|PRK
12023719|NCT00415077|Procedure|MMC PRK|mitomycin C PRK
12023720|NCT00415077|Procedure|LASEK|LASEK
12023721|NCT00415064|Drug|Perifosine|Perifosine given in either 50 mg or 100 mg / day
12023722|NCT00415064|Drug|Lenalidomide|Lenalidomide given in either 15 or 25 mg / day
12023723|NCT00415064|Drug|Dexamethasone|Dexamethasone given in 20 mg / day
12023724|NCT00415051|Biological|RVF MP-12|Administer 1 ml SQ
12023725|NCT00415038|Drug|Rostafuroxin|1 capusle of 50 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
12023726|NCT00415038|Drug|Rostafuroxin|1 capusle of 150 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
12023727|NCT00415038|Drug|Rostafuroxin|1 capusle of 500 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
12023728|NCT00415038|Drug|Rostafuroxin|1 capusle of 1.5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
12023729|NCT00415038|Drug|Rostafuroxin|1 capusle of 5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
12023730|NCT00415025|Procedure|adjuvant therapy|
12023731|NCT00415025|Procedure|management of therapy complications|
12023732|NCT00415025|Procedure|quality-of-life assessment|
12023733|NCT00415025|Radiation|intensity-modulated radiation therapy|
12023734|NCT00414999|Drug|TG100801|
12023735|NCT00414986|Behavioral|Standard CQI intervention|In-practice change facilitator assists the practice in implementing a chronic disease registry
12023795|NCT00414375|Procedure|Drainage and Interval Appendectomy|drainage with interval appendectomy
12023736|NCT00414986|Behavioral|Chronic Care Improvement (CCI) Intervention|An in-practice change facilitator will assist the Improvement Team in enhancing the relationship infrastructure of the practice and in implementing diabetes and depression office systems.
12023737|NCT00414986|Behavioral|Self-directed practice comparison|Practices will have access to all tools used in Arm 1 via a project website
12023738|NCT00414973|Drug|Teriparatide|Subcutaneous, 20 micrograms/day, 24 weeks
12023739|NCT00414973|Drug|Salmon Calcitonin|Intranasal, 200 International Units (IU)/day, 24 weeks
12023740|NCT00414960|Drug|Enzastaurin|500 mg po QD for 6 months
12023741|NCT00414960|Drug|Placebo|po QD for 6 months
12023742|NCT00414947|Drug|Vildagliptin (LAF237)|
12023743|NCT00414921|Drug|clonidine|Clonidine is FDA-approved for the treatment of hypertension in adults
12023744|NCT00414921|Drug|methylphenidate|Methylphenidate is known to safely and effectively treat many ADHD symptoms.
12023745|NCT00414921|Other|placebo|inactive substance
12023746|NCT00414908|Drug|Pancrelipase delayed release capsule|24,000 unit capsule
12023747|NCT00414908|Drug|Placebo Comparator|Placebo
12023748|NCT00414869|Drug|NCX-1000|500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days
12023749|NCT00414869|Drug|Placebo|Inactive powder matching NCX-1000
12023750|NCT00414856|Drug|AFQ056|
12023751|NCT00414817|Behavioral|Automated Phone-Based Refill Reminders|The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.
12023752|NCT00414804|Device|Precision SCS|Precision Spinal Cord Stimulation (SCS) Therapy
12023753|NCT00414804|Procedure|Nerve Blocks and PT|Pain therapy utilizing Nerve Blocks with Physical Therapy
12023754|NCT00414778|Drug|LHT344|
12023755|NCT00414765|Drug|Aldesleukin|
12023756|NCT00414752|Drug|AFQ065|
12023757|NCT00414739|Drug|Benzalkonium chloride|
12023758|NCT00414726|Drug|NBO (Normobaric Oxygen)|High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
12023759|NCT00414726|Drug|Room Air|Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
12023760|NCT00414713|Procedure|red blood cell transfusion|red blood cell transfusion
12023761|NCT00414700|Drug|ChondroCelect implantation|"10.000 cells/µl cell suspension for implantation (Autologous Chondrocyte Implantation). ChondroCelect consists of characterised autologous cartilage-forming cells expressing a specific marker profile.
~The dose depends on the size of the lesion. Recommended dose is 0.8 to 1.0 million cells/cm²."
12023762|NCT00414700|Procedure|Microfracture|A procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue.
12023763|NCT00414687|Drug|Ventavis (Iloprost, BAYQ6256)|
12023764|NCT00414661|Drug|CP-690,550|Subjects had to have received CP-690,550 or other blinded study drug in index study. No intervention in this long-term follow-up trial.
12023765|NCT00414648|Drug|Sirolimus|A sirolimus dose of 2 mg will be given in the form of 2 tablets (1 mg/tablet) per day for 1 year.
12023766|NCT00414648|Drug|Placebo sirolimus|A placebo dose of 2 mg will be given in the form of 2 tablets (1 mg/tablet) per day for 1 year.
12023767|NCT00414635|Drug|Intermitent Dosing|"Intermittent dosing treatment is the maintenance of the 5/2 schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. ."
12023768|NCT00414622|Drug|DMXB-A|
12023769|NCT00414609|Drug|Aliskiren|Aliskiren was available in 75 mg tablet, 150 mg tablet
12023770|NCT00414609|Drug|placebo|Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.
12023771|NCT00414596|Device|DRX9000™|Device is designed to apply spinal decompressive forces.
12023772|NCT00414583|Other|No intervention|Observational study, only laboratory analysis and diagnostic interventions done; no drug tested
12023773|NCT00414570|Drug|[18]F-FLT PET scan|Injection of [18]F-FLT radiopharmaceutical followed by PET imaging.
12023774|NCT00414557|Procedure|Quadriceps strengthening|
12023775|NCT00414544|Device|CosmetaLife|Dermal filler
12023776|NCT00414544|Device|Restylane|Dermal filler
12023777|NCT00414531|Drug|Atorvastatin|20 to 80 mg per day
12023778|NCT00414518|Drug|Tenofovir disoproxil fumarate/Emtricitabine|300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily
12023779|NCT00414518|Drug|Lopinavir/Ritonavir|Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily
12023780|NCT00414505|Device|Intradermal Acupuncture Treatment|
12023781|NCT00414479|Drug|praziquantl, iron, ACT|
12023782|NCT00414466|Drug|Intraspinal Gabapentin|Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
12023783|NCT00414453|Drug|Lidocaine patch 5%|lidocaine 5% patch; 12 hours on, 12 hours off
12023784|NCT00414453|Drug|Extended-release oxycodone|extended-release oxycodone titrating schedule
12023785|NCT00414453|Drug|Placebo extended-release oxycodone pills|placebo pills with titrating schedule
12023786|NCT00414453|Drug|Placebo lidocaine patches|used with extended release oxycodone group; used with placebo pills/placebo patches
12023787|NCT00414440|Drug|Placebo|placebo comparator
12023788|NCT00414440|Drug|Everolimus|experimental
12023789|NCT00414427|Procedure|Intraarticular steroids|
12023790|NCT00414414|Drug|Prednisone|
12023791|NCT00414414|Drug|placebo|placebo
12023792|NCT00414401|Behavioral|Clinical Reminder|
12023793|NCT00414388|Drug|Sorafenib|400mg twice daily
12023794|NCT00414375|Procedure|Operation on Admission|Laparoscopic appendectomy on admission
12023796|NCT00414349|Drug|Topical analgesic|max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
12023797|NCT00414349|Drug|oral intake|300 to 600 mg per day taken orally
12023798|NCT00414349|Drug|Topical analgesic|3 plasters for PHN patients per day 4 plasters for DPN patients per day
12023799|NCT00414336|Drug|AMA1-C1/Alhydrogel + CPG 7909 Vaccine|
12023800|NCT00414323|Drug|Duloxetine|
12023801|NCT00414323|Drug|Escitalopram|
12023802|NCT00414323|Drug|Placebo|
12023803|NCT00414310|Drug|Decitabine|20 mg/m^2 IV over 1 hour daily for 5 days.
12023804|NCT00414310|Drug|Valproic Acid|50 mg/kg orally daily for 7 days
12023805|NCT00414297|Device|ECP Therapy|application of ECP Therapy to CAD Patients
12023806|NCT00414284|Drug|Increased dose of Kaletra|
12023807|NCT00414271|Drug|Docetaxel|Docetaxel 60 mg/m2 IV on day 1
12023808|NCT00414271|Drug|Capecitabine|Capecitabine 900 mg/m2 PO two times per day from day 1 to day 14 every 3 weeks for 2 cycles.
12023809|NCT00414258|Procedure|breastfeeding|See detailed description.
12023810|NCT00414245|Drug|metformin|
12023811|NCT00414219|Behavioral|Visual quality of patients with corneal eye injuries|Visual quality of patients with corneal eye injuries
12023812|NCT00414206|Drug|Mecamylamine|
12023813|NCT00414206|Drug|Placebo|
12023814|NCT00414180|Drug|Bupropion SR|
12023815|NCT00414167|Drug|bupropion|300 mg per day for 8 weeks
12023816|NCT00414167|Other|Placebo|Placebo
12023817|NCT00414154|Behavioral|Group based multidisciplinary patient education programme|
12023818|NCT00414141|Biological|Grass MATA MPL|4 subcutaneous injections
12023819|NCT00414141|Biological|Placebo|4 subcutaneous injections
12023820|NCT00414128|Drug|mycophenolate mofetil|2-3g/day for 3-6 months, in tablet, capsule or liquid form
12023821|NCT00414128|Drug|cyclophosphamide|intravenous cyclophosphamide, 15mg/kg with dose reductions according to age and renal function, for 3-6 months (6-10 doses total)
12023822|NCT00414102|Drug|Ramelteon|Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.
12023823|NCT00414102|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.
12023824|NCT00414089|Drug|90Y-ibritumomab tiuxetan (Zevalin)|
12023825|NCT00414076|Drug|Letrozole|2.5 mg Tablet By Mouth Daily for 12 Weeks.
12023826|NCT00414050|Biological|Modified Process Hepatitis B Vaccine (Experimental)|Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).
12023827|NCT00414050|Biological|Hepatitis B Vaccine (Recombinant)|RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.
12023828|NCT00414050|Biological|Hepatitis B Vaccine (Recombinant)|ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months
12023829|NCT00414037|Drug|Eszopiclone|
12023830|NCT00414037|Drug|Placebo|Placebo-treatment
12023831|NCT00414024|Drug|Tegaserod|
12023832|NCT00414011|Drug|Moxifloxacin|1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
12023833|NCT00414011|Drug|Gatifloxacin|1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
12023834|NCT00413998|Procedure|CABG + Mitral valve annuloplasty|Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
12023835|NCT00413998|Procedure|CABG|Patients will undergo coronary artery bypass grafting alone.
12023836|NCT00413985|Drug|Nutrient-enriched human milk|
12023837|NCT00413972|Drug|ezetimibe with simvastatin|Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks
12023838|NCT00413972|Drug|Ezetimibe with Simvastatin|Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks
12023839|NCT00413972|Drug|Ezetimibe with Simvastatin|Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks
12023840|NCT00413972|Drug|Placebo|Placebo once daily for a total of eight weeks
12023841|NCT00413959|Drug|VELCADE®|1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
12023842|NCT00413959|Drug|Rituximab|375 mg/m^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
12023843|NCT00413959|Drug|Cyclophosphamide|400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
12023844|NCT00413959|Drug|Decadron|40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
12023845|NCT00413946|Drug|Recombinant human Erythropoietin|3 doses 3000 units (1 ml) of recombinant human erythropoietin per kg body weight
12023846|NCT00413946|Drug|saline|three doses of 1.0 ml saline per body weight
12023847|NCT00413933|Procedure|Comprehensive Multidisciplinary Intervention|Comprehensive Multidisciplinary Intervention
12023848|NCT00413920|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.
12023849|NCT00413920|Drug|Prednisone|Oral tablets
12023850|NCT00413894|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa
12023851|NCT00413881|Procedure|WAVEFRONT- GUIDED LASIK ENHANCEMENT|Laser treatment to correct residual refractive error left over from initial LASIK correction using wavefront guided LADARvision 4000 excimer laser system
12023852|NCT00413881|Procedure|CONVENTIONAL LASIK ENHANCEMENT|Laser treatment to correct residual refractive error left over from initial LASIK correction using LADARvision 4000 excimer laser system.
12023853|NCT00413868|Procedure|LASIK|
12023854|NCT00413868|Procedure|PRK|
12023855|NCT00413868|Behavioral|Small target contrast sensitivity and disability glare|
12023856|NCT00413855|Procedure|laparoscopic appendectomy or not (surgery)|
12023857|NCT00413829|Drug|Intravitreal ranibizumab with photodynamic therapy|Intravitreal injection, photodynamic therapy
12023858|NCT00413803|Procedure|4-hour thrice weekly in center hemodialysis|conventional hemodialysis
12023859|NCT00413803|Procedure|8-hour thrice weekly in center hemodialysis|long dialysis
12023860|NCT00413790|Drug|Darifenacin|Darifenacin tablets 15 mg once daily
12023861|NCT00413790|Drug|Tolterodine|Tolterodine extended release (ER) 4 mg once daily
12023862|NCT00413790|Drug|Placebo|Placebo tablet once daily
12023863|NCT00413777|Drug|Tolvaptan|Participants were titrated to either the tolvaptan 45/15 or 60/30 mg split-dose over a 2-month Titration Period. They received the titrated dose for 34 months during the Fixed-dose Period. Following a planned off-treatment period, participants had the option to enter an Extension Period for an additional 12 months. Tolvaptan was supplied as tablets.
12023864|NCT00413764|Drug|tibolone|tibolone (2.5 mg) over 24 weeks
12023865|NCT00413764|Drug|estradiol-norethisterone|transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks
12023866|NCT00413751|Drug|Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)|
12023867|NCT00413738|Device|Antiseptic-coated central venous catheters|
12023868|NCT00413725|Biological|MRKAd5 HIV-1 gag/pol/nef|Experimental Clade-B based Adenovirus serotype 5 HIV-1 gag/pol/nef vaccine
12023869|NCT00413725|Other|Placebo|Placebo
12023870|NCT00413712|Drug|Calcium Channel Blocker & Adenosine|
12023871|NCT00413699|Drug|CP-690,550|5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
12023872|NCT00413699|Drug|CP-690,550|10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
12023873|NCT00413686|Drug|AZD7762|intravenous infusion
12023874|NCT00413686|Drug|Gemcitabine|weekly intravenous infusion
12023875|NCT00413673|Procedure|PRK|PRK
12023876|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
12023877|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
12023878|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
12023879|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
12023880|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
12023881|NCT00413660|Drug|CP-690,550|Oral tablets
12023882|NCT00413660|Other|placebo|Placebo
12023883|NCT00413647|Drug|CardioPET|
12023884|NCT00413634|Drug|anagrelide hydrochloride|Anagrelide hydrochloride 0.5 mg per capsule; patients will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the patient specific anagrelide dose will be administered from a controlled study specific supply.
12023885|NCT00413608|Drug|Clopidogrel|Clopidogrel
12023886|NCT00413595|Other|No intervention|Observational, epidemiological, prognosis study; no drug tested; only laboratory analysis and diagnostic interventions done.
12023887|NCT00413582|Drug|Epidural Analgesia|Upon arrival to the operating room, patients will have a thoracic epidural (T 6-9) placed while in the sitting position. All epidural catheters will be inserted 3-5 cm within the epidural space and will be placed by attending anesthesiologists. Patients will receive midazolam 0.025 - 0.05 mg/kg IV (max 5mg) and/or fentanyl 0.5 - 2 mcg/kg IV for comfort during the procedure. Once the epidural is placed, the patient will be positioned for surgery. The epidural catheter will be initially bolused with 0.3ml/kg of ropivacaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivacaine 0.10%, fentanyl 2mcg/ml and clonidine 1.5mcg/ml will be initiated immediately at the rate of 0.3ml/kg/hr (max 10ml/hr). Intraoperatively, patients will receive intravenous fentanyl if indicated.
12023888|NCT00413582|Drug|Patient-Controlled IV Analgesia|In the PCA arm, patients will receive fentanyl (3-6 mcg/kg) at anesthesia induction. Additional fentanyl may be administered intraoperatively as indicated. Patients who are > 35 Kg. (in keeping with current FDA approved labeling) will receive a clonidine 0.1 mg/day transdermal patch to the deltoid immediately after induction of anesthesia. Subjects in the epidural arm also receive clonidine. Upon arrival to the post anesthesia care unit, patients will be placed on a patient controlled analgesic (PCA) pump (hydromorphone: loading dose if needed; 5-6 mcg/kg continuous infusion; 5-6 mcg/kg six minute demand dose). An additional hydromorphone dose (8mcg/kg) will be available every 2 hours for pain scores of > 4/10 throughout the duration of PCA use.
12023889|NCT00413569|Procedure|cervical spine surgery|
12023890|NCT00413556|Biological|ALK Grass tablet|
12023891|NCT00413543|Other|early pulmonary lung rehabilitation|early pulmonary rehabilitation, 10 days after discharge
12023892|NCT00413517|Procedure|Epi-Lasik|A vision correcting surgery
12023893|NCT00413504|Drug|Fondaparinux|
12023894|NCT00413491|Procedure|MR mammography|MR mammography
12023895|NCT00413491|Procedure|MR|MR
12023896|NCT00413478|Drug|5-Azacytidine|Starting dose level: 75mg/m^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
12023897|NCT00413465|Drug|Escherichia Coli Endotoxin|
12023898|NCT00413452|Drug|Etanercept|50 mg once weekly
12023899|NCT00413439|Drug|Isavuconazole|Intravenous solution or oral capsules
12023900|NCT00413426|Drug|Darifenacin (DAR328)|
12023901|NCT00413413|Drug|Valsartan/amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
12023902|NCT00413413|Drug|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
12023903|NCT00413413|Drug|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
12023904|NCT00413400|Drug|Etanercept|50 mg one syringe sc 2X per week for three months followed by 50 mg one syringe sc 1X per week for three months
12023905|NCT00413400|Drug|Placebo|50 mg one syringe sc 2x per week for three months followed by 50 mg one syringe sc 1X per week for three months
12023906|NCT00413387|Drug|beclomethasone dipropionate plus formoterol fumarate combination|100mcg beclomethasone diproprionate plus 6 mcg formoterol
12023907|NCT00413387|Drug|budesonide plus formoterol combination|200mcg budesonide plus 6 mcg formoterol
12023908|NCT00413374|Drug|Enoxaparin|Patient takes 1.5 mg per kilogram, once daily, subcutaneous injections until INR is therapeutic, then medication is stopped.
12023909|NCT00413361|Drug|versus hydroxychloroquine|versus hydroxychloroquine
12023910|NCT00413348|Drug|Lactobacillus acidophilus NCFM|
12023911|NCT00413335|Drug|Rosiglitazone|2mg to begin then 4mg, twice daily for 4 months
12023912|NCT00413335|Drug|Placebo|Subject receives placebo.
12023913|NCT00413322|Drug|belinostat|300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1
12023914|NCT00413322|Drug|5-Fluorouracil (5-FU)|250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.
12023915|NCT00413309|Procedure|Video Capsule Endoscopy|Noninvasive pill endoscopy is undertaken after 90 days of Aspirin/Clopidogrel in patients who have had percutaneous coronary intervention with drug-eluting stents.
12023916|NCT00413296|Drug|levetiracetam|Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
12023917|NCT00413296|Drug|Placebo|Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
12023918|NCT00413296|Drug|Levetriracetam|Tablets, 500 mg each (1-6 tablets/day) for 8 wks during the open label phase and for 12 wks during the 2nd phase of the study.
12023919|NCT00413283|Biological|Romiplostim|Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
12023920|NCT00413283|Drug|Placebo|Placebo subcutaneous injection.
12023921|NCT00413283|Drug|Gemcitabine|Intravenous infusion
12023922|NCT00413283|Drug|Carboplatin|Intravenous infusion
12023923|NCT00413283|Drug|Cisplatin|Intravenous infusion
12023924|NCT00413270|Drug|nilotinib|
12023925|NCT00413257|Drug|Nefopam|0,3mg/kg IV bolus preoperative and 65 µg/kg/h during H48 postoperative
12023926|NCT00413257|Drug|néfopam|bolus Néfopam (0,3mg/kg) during 10 min at the end of surgery and 65 µg/kg/h during postoperative H48
12023927|NCT00413257|Drug|Placebo comparator|bolus NaCl during 10 min at the end of surgery and during postoperative H48
12023928|NCT00413244|Drug|AndroGel 5 Grams|"Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
~Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months."
12023929|NCT00413244|Drug|Placebo|"Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
~Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months."
12023930|NCT00413231|Device|Valiant Thoracic Stent Graft System|Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
12023931|NCT00413218|Drug|Isavuconazole|Administered by intravenous infusion.
12023932|NCT00413218|Drug|Caspofungin|Administered by intravenous infusion.
12023933|NCT00413218|Drug|Voriconazole|Administered by intravenous infusion.
12023934|NCT00413205|Drug|Placebo|po daily
12023935|NCT00413205|Drug|RAR Gamma|5mg po daily
12023936|NCT00413192|Drug|E7389|1.4 mg/m^2 administered as an intravenous (I.V.) bolus infusion on Days 1 and 8 of every 21 days.
12023937|NCT00413179|Drug|Metformin|
12023938|NCT00413179|Drug|Clomiphene citrate|
12023939|NCT00413179|Drug|Placebo|
12023940|NCT00413166|Drug|All-Trans Retinoic Acid (ATRA)|Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1
12023941|NCT00413166|Drug|Arsenic Trioxide (ATO)|Induction: 0.15 mg/kg daily IV beginning day 1
12023942|NCT00413166|Drug|Idarubicin|"12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
~If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date."
12023943|NCT00413166|Drug|Gemtuzumab Ozogamicin|Induction: 9 mg/m2 on day 1 of induction
12023944|NCT00413153|Drug|atazanavir/ritonavir|atazanavir 300mg + ritonavir 100mg once daily
12023945|NCT00413153|Drug|lopinavir/ritonavir|patient remains on their pre-study dose of lopinavir/ritonavir
12023946|NCT00413127|Drug|lidocaine|administration of lidocaine intravenously or epidural or administration of placebo
12023947|NCT00413127|Drug|NaCl 0,9%|Administration of placebo i.v.
12023948|NCT00413114|Drug|Obatoclax mesylate (GX15-070MS)|
12023949|NCT00413101|Drug|epoetin beta [NeoRecormon]|At a dose to achieve and maintain an Hb level of 120-135g/L
12023950|NCT00413088|Drug|bemiparin|
12023951|NCT00413075|Drug|oral belinostat|oral belinostat dosed once or twice daily at continuous and discontinuous dosing schedules.
12023952|NCT00413062|Drug|NOMAC-E2|Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
12023953|NCT00413062|Drug|DRSP-EE|Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
12023954|NCT00413049|Drug|Valsartan/amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
12023955|NCT00413049|Drug|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
12023956|NCT00413036|Drug|lenalidomide|once daily oral capsule
12023957|NCT00413023|Drug|GW679769|
12023958|NCT00413010|Drug|pregabalin|pregabalin 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period
12023959|NCT00413010|Drug|placebo|placebo + concurrent GAD treatment from the open-label study period
12023960|NCT00412997|Drug|LBH589|
12023961|NCT00412984|Drug|warfarin|Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
12023962|NCT00412984|Drug|apixaban|Oral tablets, 5.0 mg or 2.5 mg, twice daily
12023963|NCT00412971|Drug|Hexvix|Single installation, TURB
12023964|NCT00412971|Other|Standard white light cystoscopy|
12023965|NCT00412958|Drug|Ocriplasmin 25µg|Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.
12023966|NCT00412958|Drug|Ocriplasmin 75µg|Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.
12023967|NCT00412958|Drug|Ocriplasmin 125µg|Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.
12023968|NCT00412958|Drug|Placebo|Intravitreal injection of placebo
12023969|NCT00412932|Drug|Olmesartan medoxomil|Tablets
12023970|NCT00412932|Drug|Olmesartan medoxomil/hydrochlorothiazide|Tablets
12023971|NCT00412919|Drug|Azacitidine|
12023972|NCT00412906|Drug|Escherichia Coli Endotoxin|
12023973|NCT00412893|Drug|Isavuconazole|Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
12023974|NCT00412893|Drug|Voriconazole|Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
12023975|NCT00412880|Drug|BI 2536|
12023976|NCT00412867|Drug|Alteplase|0.6 mg/kg of Alteplase is intravenously administered
12023977|NCT00412854|Biological|Infanrix™/Hib|
12023978|NCT00412854|Biological|Infanrix|
12023979|NCT00412854|Biological|Hiberix|
12023980|NCT00412841|Drug|Atorvastatin|Atorvastatin 40mg vs placebo 40mg daily
12023981|NCT00412841|Procedure|MRI, Venipuncture|MRIs done baseline, four and nine months
12023982|NCT00412841|Drug|Placebo|Tablets identical to atorvastatin 40mg
12023983|NCT00412828|Drug|CR011-vcMMAE|administered as an intravenous infusion of 250 mL over 90 min
12023984|NCT00412815|Behavioral|Exercise training|
12023985|NCT00412802|Drug|dose adaptation of Enoxaparin|A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min.
12023986|NCT00412802|Drug|normal injection of Enoxaparine|No dose adaptation of Enoxaparine
12023987|NCT00412789|Drug|Patupilone|
12023988|NCT00412776|Drug|Proxinium|700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
12023989|NCT00412763|Drug|Silymarin (Silybum marianum)|
12023990|NCT00412750|Drug|Telbivudine (LdT)|600 mg orally once daily for 104 weeks.
12023991|NCT00412750|Drug|peginterferon alpha-2a|180 μg subcutaneous injection once a week for 52 weeks.
12023992|NCT00412737|Drug|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
12023993|NCT00412737|Drug|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
12023994|NCT00412698|Drug|rimonabant|"Administration of one tablet containing 20 mg of active rimonabantonce daily in the morning.
~White film-coated tablets, for oral administration containing 20 mg of active rimonabant"
12023995|NCT00412698|Drug|Placebo|Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.
12023996|NCT00412659|Procedure|Surgery for pilonidal disease, midline excision|A midline excision is made for the treatment of pilonidal sinus disease.
12023997|NCT00412659|Procedure|Surgery for pilonidal disease, Karydakis operation|A Karydakis operation is done for the treatment of pilonidal sinus disease.
12023998|NCT00412646|Drug|TMC125|
12023999|NCT00412633|Behavioral|Diet and physical activity interventions|Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.
12024000|NCT00412633|Behavioral|Computer technology to tailor, promote and sustain health behavior change & improve health care delivery.|Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.
12024001|NCT00412620|Drug|ABT-925|
12024002|NCT00412620|Drug|Placebo|
12024003|NCT00412607|Device|NAVISTAR® THERMOCOOL® Catheter|The primary objective is to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease
12024004|NCT00412594|Drug|Cladribine|Given IV
12024005|NCT00412594|Other|Laboratory Biomarker Analysis|Correlative studies
12024006|NCT00412594|Biological|Rituximab|Given IV
12024007|NCT00412581|Drug|Lenalidomide|25 mg by mouth daily for 2 weeks, followed by 1 week of rest.
12024008|NCT00412581|Drug|Dacarbazine|600 mg/m^2 intravenously on Day 1 of every study cycle.
12024009|NCT00412568|Procedure|Photorefractive Keratectomy (PRK)|vision correction with PRK
12024010|NCT00412555|Drug|oseltamivir [Tamiflu]|30-75mg po daily for 6 weeks
12024011|NCT00412542|Drug|Thalidomide|100 mg PO (by mouth) daily for 8 weeks
12024012|NCT00412542|Drug|CPT-11|125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest
12024013|NCT00412542|Procedure|MRI Scan|Dynamic MRI scan with dye injection through vein, every 6 weeks
12024014|NCT00412542|Procedure|Quantitative Sensory Tests (QST)|QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.
12024015|NCT00412529|Drug|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
12024016|NCT00412529|Drug|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
12024017|NCT00412516|Biological|Live attenuated SA 14-14-2 vaccine|Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
12024018|NCT00412503|Drug|Topotecan, Temozolomide|
12024019|NCT00412490|Behavioral|Questionnaire|Written survey at 1 Month & 6 Months post surgery.
12024020|NCT00412490|Behavioral|Interview|One-on-One meeting lasting about one hour, at 1 Month & 6 Months post surgery.
12024123|NCT00411606|Procedure|Thermography|Subjects will have a picture of their face taken with a thermal camera
12024021|NCT00412477|Biological|HIV LFn-p24|HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed at 200 µg/ml and 600 µglml. The product will be administered IM in doses ranging from 150µg to 450µg with Alhydrogel.
12024022|NCT00412464|Drug|Fondaparinux|Fondaparinux 0.1 mg/kg (up to 7.5 mg max initial dose) once daily for up to 21 days.
12024023|NCT00412451|Drug|ocriplasmin|Intravitreal injection, single administration
12024024|NCT00412451|Other|Sham injection|Sham intravitreal injection
12024025|NCT00412425|Drug|Palonosetron|0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.
12024026|NCT00412412|Drug|CNF2024|Oral doses of CNF2024 as specified in the protocol.
12024027|NCT00412412|Drug|CNF2024 + trastuzumab|Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert.
12024028|NCT00412373|Drug|Placebo|for 6 weeks
12024029|NCT00412373|Drug|Paliperidone ER|(3-12mg/day in 3 mg/day increments for 6 weeks)
12024030|NCT00412373|Drug|Paliperidone ER|(3-12mg/day in 3 mg/day increments for 6 weeks)
12024031|NCT00412360|Biological|Single Umbilical Cord Blood Unit Transplant|Unrelated donor, single umbilical cord blood unit; conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
12024032|NCT00412360|Biological|Double Umbilical Cord Blood Unit Transplant|Unrelated donor, double umbilical cord blood unit; Conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
12024033|NCT00412360|Radiation|Total Body Irradiation|The TBI will be delivered from either a linear accelerator or cobalt source at a dose rate of between 4 and 26 cGy/minute using energies of between 1 and 25 MV.
12024034|NCT00412360|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day will be administered as a 2 hour intravenous infusion with a high volume fluid flush on Days -3 and -2.
12024035|NCT00412360|Drug|Fludarabine|Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -10 through -8. Fludarabine will not be dose adjusted for body weight.
12024036|NCT00412360|Drug|Cyclosporine A|CSA will be administered beginning on Day -3 and doses will be adjusted to maintain a level of 200-400 ng/mL by TDX method (or 100-250 ng/mL by Tandem MS or equivalent level for other CSA testing methods). CSA can be administered per institutional practice.
12024037|NCT00412360|Drug|Mycophenolate Mofetil|MMF will be given at a dose of 1 gram IV q 8 hours if > 50 kg or 15 mg/kg IV q 8 hours if < 50 kg beginning the morning of Day -3.
12024038|NCT00412347|Drug|Insulin Drip Therapy|
12024039|NCT00412334|Drug|Copegus|1200-1600mg/day po
12024040|NCT00412334|Drug|Copegus|1000-1200mg/day po
12024041|NCT00412334|Drug|peginterferon alfa-2a [Pegasys]|360 micrograms sc weekly
12024042|NCT00412334|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc twice weekly
12024043|NCT00412321|Drug|CNTO 328|Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks.
12024044|NCT00412308|Procedure|Tidal volume used in mechanical ventilation|
12024045|NCT00412295|Device|Alcon Ladarvision (Wavefront-guided PRK)|Wavefront-guided PRK using Alcon Ladarvision
12024046|NCT00412256|Drug|Omegaven (10% fish-oil emulsion; Fresenius-Kabi)|
12024047|NCT00412243|Drug|Clofarabine|40 mg/m^2 Daily for 3 Days
12024048|NCT00412243|Drug|Cyclophosphamide|Beginning dose 200 mg/m^2 every 12 hours for 3 days
12024049|NCT00412217|Drug|Placebo|Participants will receive placebo tablets (matched to erlotinib) once daily.
12024050|NCT00412217|Drug|Erlotinib|Erlotinib will be given as 150 mg PO once daily.
12024051|NCT00412217|Other|Standard of care|Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.
12024052|NCT00412204|Drug|tiotropium bromide|Subjects will be randomized to treatment with tiotropium or placebo. Double-blind medication will be dispensed in HandiHalers to be taken once daily in the morning for 22 days.
12024053|NCT00412204|Other|Placebo|Subjects will be randomized to treatment with tiotropium or placebo. Double-blind medication will be dispensed in HandiHalers to be taken once daily in the morning for 22 days.
12024054|NCT00412191|Drug|Lamotrigine|In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.
12024055|NCT00412178|Device|telecommunication based glucose monitoring system|
12024056|NCT00412165|Behavioral|Cell Phone|The cell phone arm receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
12024057|NCT00412165|Behavioral|Weekly access to interactive web site|This group receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
12024058|NCT00412165|Behavioral|Group|The Group arm receives monthly face to face group sessions plus access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
12024059|NCT00412152|Drug|Oxycodone nalaxone prolonged release tablets (OXN)|
12024060|NCT00412126|Drug|Insulin|
12024061|NCT00412113|Drug|Amlodipine besylate|Amlodipine besylate 5 mg
12024062|NCT00412113|Drug|Amlodipine besylate/atorvastatin calcium single pill combination|Amlodipine/atorvastatin single pill combination 10/20 mg
12024063|NCT00412113|Drug|Amlodipine besylate|Amlodipine besylate 10 mg
12024064|NCT00412113|Drug|Amlodipine besylate/atorvastatin calcium single pill combination|Amlodipine/atorvastatin single pill combination 5/20 mg
12024065|NCT00412100|Drug|Oxycodone naloxone prolonged release tablets (OXN)|
12024066|NCT00412087|Drug|cholecalciferol (vitamin D3)|randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
12024067|NCT00412087|Drug|cholecalciferol|randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
12024276|NCT00410592|Drug|Lansoprazole 30mg|
12024068|NCT00412087|Drug|cholecalciferol|cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
12024069|NCT00412074|Drug|400 IU Vitamin D3 (cholecalciferol)|400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
12024070|NCT00412074|Drug|2400 IU Vitamin D3 (cholecalciferol)|2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
12024071|NCT00412074|Drug|6400 IU Vitamin D3 (cholecalciferol)|6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
12024072|NCT00412061|Drug|Octreotide|Octreotide 30 mg intramuscularly (i.m.) every 28 days.
12024073|NCT00412061|Drug|Placebo|A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
12024074|NCT00412061|Drug|Everolimus|A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
12024075|NCT00412048|Procedure|fMRI to detect MCI patients who will convert to Alzheimer's disease|There is a fMRI to be realized in the 3 arms. No drug is administered
12024076|NCT00412035|Drug|Botulinum toxin A injection|10 units per kilo to maximum of 400 units
12024077|NCT00412035|Drug|saline injection|10 units per kilo to maximum of 400 units
12024078|NCT00412022|Drug|tamoxifen|20 mg daily for 5 years
12024079|NCT00412022|Drug|triptorelin|Premenopausal patients will receive triptorelin 3.75 mg IM at the beginning of therapy and every 4 weeks for 5 years or up to age 55
12024080|NCT00412022|Drug|letrozole|2.5 mg daily for 5 years
12024081|NCT00412022|Drug|zoledronic acid|4 mg every 6 months
12024082|NCT00412009|Procedure|Comprehensive package of activities|
12024083|NCT00411996|Drug|indinavir/ritonavir|IDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks
12024084|NCT00411970|Device|20- and 23 gauge vitreoretinal surgery systems|
12024085|NCT00411957|Drug|Atazanavir|ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
12024086|NCT00411931|Drug|Multihance|0.5M administered as a single injection
12024087|NCT00411905|Drug|Bortezomib|
12024088|NCT00411892|Drug|pioglitazone|Tablets, 45 mg/day.
12024089|NCT00411892|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
12024090|NCT00411879|Drug|Vasopressin, Epinephrine, and Steroids|During resuscitation, study group patients receive vasopresssin [20 IU IV maximum dose = 100 IU] and methylprednisolone (40 mg IV). Epinephrine is given to both groups according to guidelines for resuscitation 2005. In the study group, postresuscitation shock is treated with stress-dose hydrocortisone.
12024091|NCT00411879|Drug|Placebo, Epinephrine, Placebo|Epinephrine is given to both groups according to guidelines for resuscitation 2005. Control group patients receive placebo instead of vasopressin and steroids.
12024092|NCT00411866|Drug|SB773812|SB-773812 20 mg will be available as white round film coated tablets.
12024093|NCT00411866|Drug|Ketoconazole|Ketoconazole will be available as 200mg tablets.
12024094|NCT00411853|Drug|Fermented Wheat germ extract|Fermented Wheat Germ powder, given orally, per os, 17 gram daily
12024095|NCT00411840|Procedure|intraarterial and intramuscular injection of BMCs|
12024096|NCT00411827|Procedure|PRK with conjunctival impression cytology before and after surgery|
12024097|NCT00411827|Procedure|LASIK with conjunctival impression cytology before and after surgery|LASIK with conjunctival impression cytology before and after surgery
12024098|NCT00411814|Drug|GSK679586|Active Drug
12024099|NCT00411814|Drug|Placebo|Saline
12024100|NCT00411801|Biological|Uniplas|Uniplas will be provided frozen in sterile plastic bags.
12024101|NCT00411801|Biological|Cryosupernatant plasma|Cryosupernatant plasma will be provided frozen in sterile plastic bags.
12024102|NCT00411788|Drug|Rapamycin|oral rapamycin 6 mg daily
12024103|NCT00411788|Drug|Trastuzumab|Trastuzumab 4 mg/kg will be administered (intravenous) on day 1, and this will be followed by weekly dose of 2 mg/kg starting day 8.
12024104|NCT00411762|Drug|Capecitabine|
12024105|NCT00411762|Drug|PHY906|
12024106|NCT00411749|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)|V501; Gardasil, 0.5 ml injection in 3 dosing regimen
12024107|NCT00411749|Biological|Comparator: Placebo (unspecified)|Placebo 0.5 ml injection in 3 dosing regimen
12024108|NCT00411736|Drug|Study medication, azithromycin or placebo|Granulate for syrup in the group under 8 years, 40 mg/ml. Dose: 5 mg/kg/day in one daily dose.
12024109|NCT00411736|Drug|Azithromycin or placebo tablets|Tablets of 250 mg, azithromycin or placebo. Dosage: 1 tablet every other day for participants with a weight less than 40 kg´s. 1 tablet every day for participants weighing 40 kg´s or more.
12024110|NCT00411723|Drug|RTL1000 (recombinant T cell receptor ligand)|Dosage form: IV infusion. Dosage: Single dose @ 2, 6, 20, 60, 100 or 200mg. Duration: 1 - 2 hours.
12024111|NCT00411723|Drug|RTL1000 Placebo|Dosage form: IV infusion. Dosage: Same volume as Experimental. Frequency: Single dose. Duration: 1 - 2 hours.
12024112|NCT00411697|Biological|Engerix™-B Kinder|Intramuscular injection, 1 dose
12024113|NCT00411684|Drug|CDB-2914|
12024114|NCT00411671|Drug|Sorafenib|400 mg By Mouth Twice Daily for 28 Days.
12024115|NCT00411658|Device|Investigational Device|
12024116|NCT00411658|Device|Experimental|
12024117|NCT00411658|Other|Cryopreserved|
12024118|NCT00411645|Drug|maribavir|100 mg twice daily for up to 12 weeks
12024119|NCT00411645|Other|placebo|twice daily for up to 12 weeks
12024120|NCT00411632|Drug|Bexarotene|400 mg/m^2 by mouth daily x 28 Days
12024121|NCT00411632|Drug|Erlotinib|150 mg by mouth daily x 28 Days
12024122|NCT00411619|Drug|Everolimus|Initial everolimus dosage will be 3 mg/m2/d taken daily or every other day, with titration to achieve a trough serum level of 5-15 ng/ml. Patients unable to tolerate levels in this range will have doses held or reduced 25% to achieve trough serum levels of 5-10 ng/ml. If trough serum level of 5-15 ng/ml is not achieved at a dosage of 3 mg/m2/d, then dosage escalation by 25% will be undertaken as tolerated. Everolimus will be similarly adjusted during the extension phase. If a subject misses more than 10 consecutive everolimus doses, additional days of everolimus treatment will be added so total duration of treatment is 6 months. If this occurs, dates of subsequent study events will be adjusted according to number of missed doses. This process will also be followed in the extension phase.
12024124|NCT00411593|Drug|Bevacizumab|15 g/kg by vein every 3 weeks on day 1 of each cycle.
12024125|NCT00411593|Drug|Bortezomib|"Phase I Starting dose: 1.6 mg/m2 by vein on days 1, 8 of each 3 week cycle.
~Phase II: MTD from Phase I."
12024126|NCT00411580|Biological|CAD106|
12024127|NCT00411580|Drug|Placebo|
12024128|NCT00411567|Drug|inhaled corticosteroid therapy|
12024129|NCT00411554|Drug|sitagliptin phosphate|sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
12024130|NCT00411554|Drug|Comparator: voglibose|voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
12024131|NCT00411541|Drug|vincristine|
12024132|NCT00411541|Drug|dexamethasone|
12024133|NCT00411528|Drug|Patupilone|
12024134|NCT00411528|Drug|prednisone|
12024135|NCT00411528|Drug|docetaxel|
12024136|NCT00411515|Drug|Mycophenolate Mofetil 2x 1g|
12024137|NCT00411489|Procedure|endolumenal surgery|
12024138|NCT00411463|Behavioral|Interpersonal and Social Rhythm Therapy (IPSRT-BPII)|"IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
12024139|NCT00411463|Drug|Seroquel|"Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder."
12024140|NCT00411450|Biological|Panitumumab|Administered by intravenous infusion
12024141|NCT00411450|Drug|FOLFIRI|Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.
12024142|NCT00411437|Drug|Tolterodine ER|
12024143|NCT00411437|Drug|Oxybutynin ER|
12024144|NCT00411424|Drug|ASK8007|IV
12024145|NCT00411424|Drug|Placebo|IV
12024146|NCT00411411|Drug|Januvia|200 mg t.i.d
12024147|NCT00411411|Drug|Placebo|Placebo
12024148|NCT00411398|Drug|Namenda/Memantine|5mg tablets, 1-4 tabs by mouth per day
12024149|NCT00411385|Drug|albumin interferon alfa-2b|900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
12024150|NCT00411385|Drug|peginterferon alfa-2a|180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
12024151|NCT00411385|Drug|Ribavirin|800mg/day for 24 weeks
12024152|NCT00411372|Drug|fluticasone propionate/salmeterol 250/50mcg combination, salmeterol 50mcg|
12024153|NCT00411359|Behavioral|Cardiac rehabilitation|Phase III cardiac rehabilitation programme
12024154|NCT00411346|Procedure|Nurse-led telemonitoring|
12024155|NCT00411333|Drug|triamcinolone acetonide (Kenalog)|
12024156|NCT00411320|Drug|oral steroid-dexamethasone|2 week steroid trial
12024157|NCT00411307|Drug|OROS hydromorphone HCI|
12024158|NCT00411281|Drug|cytarabine|Given subcutaneously
12024159|NCT00411281|Procedure|observation|No intervention
12024160|NCT00411268|Drug|OROS hydromorphone HCI SR (slow release)|
12024161|NCT00411255|Procedure|repetitive transcranial magnetic stimulation (rTMS)|Three arms on three different days 180 stimuli will be delivered to the AC with a sham coil, with the H-coil and with a standard circular coil in separate sessions.
12024162|NCT00411242|Drug|agomelatine|
12024163|NCT00411242|Drug|placebo|
12024164|NCT00411229|Drug|Capecitabine|1,000 mg/m² twice daily. Film coated tablets of 500 mg, 150mg.
12024165|NCT00411229|Drug|Oxaliplatin|IV infusion, 130mg/m²
12024166|NCT00411216|Other|Control exercises|saccadic eye movements against a plain background; no head movements
12024167|NCT00411216|Other|gaze stabilization exercises|adaptation and substitutin exercises encorporating retinal lsip and head movements
12024168|NCT00411203|Drug|Tamoxifen Citrate|
12024169|NCT00411203|Drug|Placebo|
12024170|NCT00411190|Drug|Relacatib|Subjects will administer 60 or 120 mg tablets in Session 2
12024171|NCT00411190|Drug|Acetaminophen|Acetaminophen will be administered orally
12024172|NCT00411190|Drug|Ibuprofen|Ibuprofen will be administered orally
12024173|NCT00411190|Drug|Atorvastatin|Atorvastatin will be administered orally
12024174|NCT00411177|Procedure|post-dilution on-line hemodiafiltration|post-dilution on-line hemodiafiltration, 3 times a week 4 hours
12024175|NCT00411177|Procedure|high flux hemodialysis|High-flux hemodialysis, 3 times a week 4 hours
12024176|NCT00411164|Drug|OROS hydromorphone HCI (slow release)|
12024177|NCT00411151|Drug|Sunitinib-Malate|Capsules of 50, 25 or 12,5 mg. Dosage 50 mg, 37.5 mg or 25 mg once daily until progression of disease or untolerable side effects
12024178|NCT00411138|Radiation|Radiation Therapy|External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
12024179|NCT00411138|Drug|cisplatin|cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval
12024180|NCT00411138|Drug|carboplatin|carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval
12024181|NCT00411138|Drug|Paclitaxel|paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval
12024182|NCT00411125|Drug|Oral salmon calcitonin|
12024183|NCT00411112|Procedure|blue and isotopic detection of sentinel lymph nodes|
12024184|NCT00411099|Drug|agomelatine|
12024185|NCT00411099|Drug|placebo|
12024186|NCT00411086|Biological|Rituximab|375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22.
12024187|NCT00411086|Biological|Sargramostim (GM-CSF)|250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
12024188|NCT00411073|Drug|Darapladib|
12024189|NCT00411047|Drug|gefitinib|oral drug taken daily around the same time
12024190|NCT00411034|Drug|OROS Hydromorphone HCI|
12024191|NCT00411021|Procedure|Pipelle (Endometrial Sampling)|
12024192|NCT00410995|Drug|Naproxen|
12024193|NCT00410982|Drug|Busulfan|Day -10 = 32 mg/m^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m^2 Intravenous
12024194|NCT00410982|Drug|Gemcitabine|Day -8 = 75 mg/m^2 Intravenous bolus; Day -3 = 75 mg/m^2 Intravenous bolus.
12024195|NCT00410982|Drug|Melphalan|Day -3 and Day -2 = 60 mg/m^2 Intravenous.
12024196|NCT00410982|Other|Hematopoietic Cell Transplantation|Infusion of stem cells on Day 0.
12024197|NCT00410982|Drug|Rituximab for Patients with B-Cell Malignancies|375 mg/m^2 Intravenous on Days 1 and 8.
12024198|NCT00410982|Drug|Palifermin|60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2
12024199|NCT00410969|Device|ThermoSuit(R) System|The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water.
12024200|NCT00410956|Biological|bevacizumab|
12024201|NCT00410956|Drug|dexamethasone|
12024202|NCT00410956|Drug|floxuridine|
12024203|NCT00410956|Genetic|protein expression analysis|
12024204|NCT00410956|Other|flow cytometry|
12024205|NCT00410956|Other|immunoenzyme technique|
12024206|NCT00410956|Other|immunohistochemistry staining method|
12024207|NCT00410956|Other|immunologic technique|
12024208|NCT00410956|Other|laboratory biomarker analysis|
12024209|NCT00410956|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
12024210|NCT00410943|Drug|OROS Hydromorphone HCI SR (slow release)|
12024211|NCT00410930|Biological|Subcutaneous immunotherapy - Recombinant birch pollen|
12024212|NCT00410904|Drug|cediranib maleate|
12024213|NCT00410904|Drug|pemetrexed disodium|
12024214|NCT00410891|Drug|gatifloxacin|
12024215|NCT00410878|Drug|OROS Hydromorphone HCI (slow release)|
12024216|NCT00410865|Genetic|INGN 201|Mouth rinse given one time on the first day and two times on Days 2-5 of each course of INGN 201. The injection and rinse (first day of each cycle), or the two rinses (Days 2-5 of each cycle), will be separated by at least two hours.
12024217|NCT00410852|Procedure|Computer-assisted IV insulin infusion protocol (algorithm A)|Computer assisted insulin protocol (CAIP), with continuous intravenous insulin adjustments aiming blood glucose levels between 100 mg/dl and 130 mg/dl.
12024218|NCT00410852|Procedure|Leuven Strict glycemic control protocol (Algorithm B)|Leuven protocol: continuous intravenous insulin infusion aimiming blood glucose levels between 80mg/dl and 110mg/dl.
12024219|NCT00410852|Procedure|Conventional Intermittent Insulin Protocol (Algorithm C)|Conventional treatment: intermitent subcutaneous insulin according to a sliding scale, starting with blood glucose levels higher than 150mg/dl.
12024220|NCT00410839|Procedure|ALA rich diet|
12024221|NCT00410826|Drug|erlotinib hydrochloride|Given orally
12024222|NCT00410826|Drug|cisplatin|Given IV
12024223|NCT00410826|Radiation|3-dimensional conformal radiation therapy|35 fractions
12024224|NCT00410826|Radiation|intensity-modulated radiation therapy|35 fractions
12024225|NCT00410826|Procedure|quality-of-life assessment|Ancillary studies
12024226|NCT00410813|Drug|dasatinib|given orally
12024227|NCT00410787|Drug|OROS hydromorphone HCI (slow release)|
12024228|NCT00410774|Biological|bevacizumab|
12024229|NCT00410774|Drug|gemcitabine hydrochloride|
12024230|NCT00410774|Procedure|adjuvant therapy|
12024231|NCT00410761|Drug|ZD6474 (Vandetanib)|once daily oral tablet
12024232|NCT00410748|Drug|OROS hydromorphone HCI CR|
12024233|NCT00410735|Drug|Placebo|0 mg BID for 12 weeks
12024234|NCT00410735|Drug|Pranlukast hydrate|225 mg BID for 12 weeks
12024235|NCT00410722|Dietary Supplement|Whole wheat and bran muffin|
12024236|NCT00410722|Dietary Supplement|Mixed tree nuts|
12024237|NCT00410709|Drug|NatrOVA Creme Rinse (1%)|
12024238|NCT00410696|Drug|Filgrastim|5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
12024239|NCT00410696|Drug|Pegfilgrastim|6 mg/day sc at day +1
12024240|NCT00410683|Other|clinical observation|
12024241|NCT00410683|Procedure|adjuvant therapy|
12024242|NCT00410683|Radiation|3-dimensional conformal radiation therapy|
12024243|NCT00410657|Biological|alemtuzumab|
12024244|NCT00410657|Drug|methylprednisolone|
12024245|NCT00410657|Drug|prednisone|
12024246|NCT00410657|Other|flow cytometry|
12024247|NCT00410657|Other|immunologic technique|
12024248|NCT00410657|Other|pharmacological study|
12024249|NCT00410644|Drug|OROS Hydromorphone HCI|
12024250|NCT00410631|Biological|filgrastim|
12024251|NCT00410631|Drug|carboplatin|
12024252|NCT00410631|Drug|cisplatin|
12024253|NCT00410631|Drug|cyclophosphamide|
12024254|NCT00410631|Drug|dacarbazine|
12024255|NCT00410631|Drug|doxorubicin hydrochloride|
12024256|NCT00410631|Drug|etoposide phosphate|
12024257|NCT00410631|Drug|ifosfamide|
12024258|NCT00410631|Drug|isotretinoin|
12024259|NCT00410631|Drug|melphalan|
12024260|NCT00410631|Drug|topotecan hydrochloride|
12024261|NCT00410631|Drug|vincristine sulfate|
12024262|NCT00410631|Drug|vindesine|
12024263|NCT00410631|Procedure|autologous hematopoietic stem cell transplantation|
12024264|NCT00410631|Procedure|conventional surgery|
12024265|NCT00410631|Procedure|peripheral blood stem cell transplantation|
12024266|NCT00410631|Radiation|iobenguane I 131|
12024267|NCT00410631|Radiation|radiation therapy|
12024268|NCT00410618|Procedure|cognitive assessment|
12024269|NCT00410618|Procedure|magnetic resonance imaging|
12024270|NCT00410618|Procedure|management of therapy complications|
12024271|NCT00410605|Biological|bevacizumab|Given IV
12024272|NCT00410605|Drug|lenalidomide|Given orally
12024273|NCT00410605|Drug|dexamethasone|Given orally
12024274|NCT00410592|Drug|Esomeprazole 40mg|
12024275|NCT00410592|Drug|Pantoprazole 40mg|
12024277|NCT00410579|Other|Telephone interview|Telephone interview to assess generic health status, quality of life, comorbidity, impact of cancer, use of medical services, health rating, pain, fatigue, activities of daily living, demographics, functional well-being(C-06 only), and neurotoxicity (C-07 only)
12024278|NCT00410566|Drug|rhASM|Single dose of 0.03mg/kg body weight IV
12024279|NCT00410566|Drug|rhASM|Single dose of 0.1mg/kg body weight IV
12024280|NCT00410566|Drug|rhASM|Single dose of 0.3mg/kg body weight IV
12024281|NCT00410566|Drug|rhASM|Single dose of 0.6mg/kg body weight IV
12024282|NCT00410566|Drug|rhASM|Single dose of 1.0mg/kg body weight IV
12024283|NCT00410553|Drug|Eribulin Mesylate|Given IV
12024284|NCT00410553|Drug|Gemcitabine Hydrochloride|Given IV
12024285|NCT00410540|Drug|OROS hydromorphone HCL ; Morphine sulfate|
12024286|NCT00410527|Drug|Merrem|
12024287|NCT00410514|Drug|Mirabegron|oral
12024288|NCT00410514|Drug|Placebo|oral
12024289|NCT00410501|Drug|Indacaterol (QAB149)|
12024290|NCT00410488|Drug|Palonosetron - Single Dose|0.25 mg by vein for 1 dose (day 0).
12024291|NCT00410488|Drug|Palonosetron - Triple Dose|0.25 mg by vein for 3 doses (days 0, 2, 4).
12024292|NCT00410488|Drug|Adriamycin|75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
12024293|NCT00410488|Drug|Ifosfamide chemotherapy (AI)|Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
12024294|NCT00410488|Drug|Zinecard|750 mg/m2 as an IV bolus.
12024295|NCT00410488|Drug|Mesna|500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
12024296|NCT00410488|Drug|Vincristine|"2 mg IV by rapid administration on day 0 (for patients with small cell histology).
~For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only."
12024297|NCT00410488|Drug|Dexamethasone|IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
12024298|NCT00410462|Drug|brostallicin|
12024299|NCT00410462|Drug|doxorubicin hydrochloride|
12024300|NCT00410449|Drug|Alpha tocopherol|
12024301|NCT00410436|Behavioral|Resistance Exercise|Subjects demonstrating adequate compliance during the run-in period will then be randomized in equal numbers to Resistance Training (R) 3X/week progressing to 3 sets, 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times in a controlled manner, maintaining proper form (8RM), or waiting-list control (C).
12024302|NCT00410423|Drug|Bortezomib with mitoxantrone, etoposide and cytarabine|All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
12024303|NCT00410423|Drug|Bortezomib 1.0mg/m^2|All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
12024304|NCT00410423|Drug|Bortezomib 1.3mg/m^2|All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
12024305|NCT00410410|Drug|abatacept (ABA)|"Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57 (ABA 30/~10 mg/kg Group).
~Induction Period 3 months
~Maintenance Period 12 months"
12024306|NCT00410410|Drug|placebo|"Normal saline, IV, 0 mg/kg, every 28 days.
~Induction Period 3 months
~Maintenance Period 12 months"
12024307|NCT00410410|Drug|abatacept|"~10 mg/kg, once monthly
~Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued"
12024308|NCT00410397|Procedure|Osteopathic Manipulative Medicine|Pelvic balancing, myofascial release of the anterior pelvis.
12024309|NCT00410397|Procedure|Sham Manipulation|Neutral positional, gentle palpation
12024310|NCT00410384|Drug|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
12024311|NCT00410384|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
12024312|NCT00410384|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
12024313|NCT00410371|Drug|Lamotrigine|Lamotrigine
12024314|NCT00410371|Drug|GI267119|25 mg ODT
12024315|NCT00410358|Drug|Gimatecan|
12024316|NCT00410345|Drug|Mifepristone|
12024317|NCT00410332|Drug|Traumeel S|homeopathic remedy
12024318|NCT00410332|Drug|Placebo|placebo drug, identical in size, form and taste as treatment remedy
12024319|NCT00410319|Behavioral|Fear-reducing Information|
12024320|NCT00410319|Behavioral|Symptom-based exercise|
12024321|NCT00410306|Drug|Testosterone Undecanoate (Nebido, BAY86-5037)|Patients from routine practice
12024322|NCT00410293|Procedure|NT-proBNP testing|
12024323|NCT00410280|Biological|IMA-638 is a biologic|
12024324|NCT00410254|Drug|HCV-796|
12024325|NCT00410254|Drug|midazolam|
12024326|NCT00410228|Drug|AHT956|
12024327|NCT00410215|Drug|picosalax plus bisacodyl|10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax
12024328|NCT00410215|Drug|picosalax|two sachets of picosalax taken orally the day prior to colonoscopy
12024329|NCT00410215|Drug|sodium phosphate|two 45 ml bottles of sodium phosphate the day prior to colonoscopy
12024330|NCT00410202|Drug|Entecavir|Tablets, Oral, 1mg, once daily, 100 weeks
12024331|NCT00410202|Drug|Tenofovir|Tablets, Oral, 300 mg, once daily
12024332|NCT00410202|Drug|Adefovir|Tablets, Oral, 10mg, once daily, 100 weeks
12024333|NCT00410202|Drug|Lamivudine|Tablets, Oral, 100mg, once daily, 100 weeks
12024334|NCT00410189|Drug|ZD6474|300 mg by mouth daily for 28 Days.
12024335|NCT00410176|Behavioral|sanitation and personal hygiene|
12024419|NCT00409526|Drug|Inhaled Iloprost|50 micrograms for one hour followed by 100 micrograms for one hour
12024420|NCT00409500|Drug|AQW051|
12024336|NCT00410163|Drug|Ofatumumab 500mg|Ofatumumab 500mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.
12024337|NCT00410163|Drug|Ofatumumab 1000mg|Ofatumumab 1000mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.
12024338|NCT00410163|Drug|Fludarabine|Fludarabine (25 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses
12024339|NCT00410163|Drug|Cyclophosphamide|Cyclophosphamide (250 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses.
12024340|NCT00410150|Drug|Helium-oxygen-driven albuterol nebulizer|Subjects will be treated with continuous albuterol nebs with Heliox
12024341|NCT00410150|Drug|Oxygen|Subjects will be treated with continuous albuterol nebs in oxygen
12024342|NCT00410124|Drug|RAD001|The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day.
12024343|NCT00410124|Drug|Placebo|
12024344|NCT00410098|Behavioral|Bikram Yoga|
12024345|NCT00410085|Drug|L-NMMA (N-mono.methyl-L-arginine)|
12024346|NCT00410072|Drug|Entecavir|Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
12024347|NCT00410072|Drug|Entecavir + Tenofovir|Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
12024348|NCT00410059|Drug|Erlotinib|150 mg by mouth daily x 28 days
12024349|NCT00410046|Drug|Enbrel (etanercept)|Etanercept 50 mg SC injection once weekly
12024350|NCT00410033|Drug|soluble human insulin|
12024351|NCT00410033|Drug|isophane human insulin|
12024352|NCT00410033|Drug|insulin aspart|
12024353|NCT00410020|Behavioral|Alpha-linolenic enriched diet|
12024354|NCT00410007|Behavioral|High Sodium Diet|250-350 mmol
12024355|NCT00410007|Behavioral|Low Sodium Diet|25-35 mmol
12024356|NCT00410007|Behavioral|Hypertonic saline infusion|7 ml/ kg of 3% saline were given over 30 minutes.
12024357|NCT00409994|Drug|Rapamycin|dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days
12024358|NCT00409981|Device|paclitaxel coated balloon catheter (device with drug)|
12024359|NCT00409968|Procedure|Tumor Biopsy|A sample of tumor tissue will be collected by either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node).
12024360|NCT00409955|Procedure|Lamellar transplant with lyophilized corneas|
12024361|NCT00409942|Drug|Torasemide Prolonged Release|Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
12024362|NCT00409942|Drug|Furosemide|Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
12024363|NCT00409929|Drug|AEB071|
12024364|NCT00409916|Device|BioZ Dx|
12024365|NCT00409903|Drug|Eprosartan|
12024366|NCT00409890|Drug|Hyoscine Butyl Bromide|
12024367|NCT00409864|Procedure|Endoscopic biliary stenting, Percutaneous biliary stenting|percutaneous 10 F stent, endoscopic 10 F stent insertion
12024368|NCT00409851|Drug|valsartan+amlodipine|
12024369|NCT00409838|Drug|Abatacept|Intravenous (IV) solution, - weight tiered (500 mg <60 kg); (750 mg 60-100 kg); (1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
12024370|NCT00409838|Drug|Methotrexate|Tablets, Oral, ≥ 15 mg, weekly, 6 months
12024371|NCT00409838|Drug|Placebo|IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
12024372|NCT00409838|Drug|Abatacept|Solution, intravenous, 10 mg/kg, every 28 days
12024373|NCT00409838|Drug|Methotrexate|Tablets, oral, 15 mg weekly to be adjusted according to patient condition
12024374|NCT00409825|Drug|17-OHPC|Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.
12024375|NCT00409825|Procedure|Blood Draws|10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.
12024376|NCT00409799|Drug|I-0401 (a new bone graft substitute)|1 time application
12024377|NCT00409786|Behavioral|Virtual Lifestyle Management (VLM)|16 weekly lessons followed by monthly maintenance lessons
12024378|NCT00409773|Drug|ezetimibe (+) simvastatin|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
12024379|NCT00409773|Drug|Comparator: atorvastatin calcium|"Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.
~Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks."
12024380|NCT00409773|Drug|Comparator: Placebo (unspecified)|"Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.
~ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.
~Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks."
12024381|NCT00409760|Drug|valsartan+amlodipine combination, valsartan, amlodipine|
12024382|NCT00409747|Drug|Minocycline|
12024383|NCT00409734|Behavioral|Children with pyloric stenosis|Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
12024384|NCT00409734|Behavioral|Children without pyloric stenosis|Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
12024385|NCT00409721|Drug|Memantine|
12024386|NCT00409708|Drug|Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy|
12024387|NCT00409708|Behavioral|Behavior Therapy|
12024388|NCT00409695|Drug|Low Dose Thymoglobulin (ATG)|2.5 mg /kg by vein every other day for 3 doses (total dose = 7.5 mg/ kg).
12024389|NCT00409695|Drug|High Dose Thymoglobulin (ATG)|1.25mg/kg by vein every other day for 3 doses (total dose = 3.75mg/kg)
12024390|NCT00409682|Biological|Adalimumab|All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
12024391|NCT00409682|Biological|Adalimumab|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
12024392|NCT00409682|Biological|Adalimumab|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
12024393|NCT00409669|Device|Barraquer tonometer|barraquer tonometer
12024394|NCT00409656|Drug|Basiliximab|
12024395|NCT00409643|Drug|valsartan+amlodipine combination|
12024396|NCT00409643|Drug|valsartan|
12024397|NCT00409643|Drug|amlodipine|
12024398|NCT00409630|Drug|fluticasone|
12024399|NCT00409617|Biological|adalimumab|Adalimumab 40 mg Every Other Week dosing
12024400|NCT00409617|Biological|adalimumab|Adalimumab 40 mg Every Week dosing if participant experiences a disease flare or is not responding to treatment. A disease flare is defined as an increase of 3 points or more on the HBI compared to the Baseline score and a total HBI score of 7 or higher. Non-response is defined as a decrease by fewer than 3 points in the HBI compared to Baseline.
12024401|NCT00409604|Device|Temporary RV VVI pacing|temporary pacing at the onset of revascularisation
12024402|NCT00409591|Drug|Maternal and infant nevirapine|"In women, one NVP 200 mg tablet at onset of labor;
~In neonates, NVP oral suspension 6 mg in the delivery room immediately"
12024403|NCT00409591|Drug|Maternal placebo and infant nevirapine|"In women, one placebo tablet at onset of labor;
~In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
~Comparison between Arms 1 and 2 is double-blinded."
12024404|NCT00409591|Drug|Maternal lopinavir+ritonavir|- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
12024405|NCT00409591|Drug|zidovudine|In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
12024406|NCT00409578|Drug|Placebo|Placebo tablets and capsules. In order to adequately blind the study, patients were required to take a total of 1 tablet and 2 capsules during the first 4 weeks of the study. During the remainder of the study, patients were required to take 2 tablets and 2 capsules. Each dose was taken by mouth with water at approximately 8:00 AM with or without food.
12024407|NCT00409578|Drug|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.
12024408|NCT00409578|Drug|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.
12024409|NCT00409578|Drug|Aliskiren/valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.
12024410|NCT00409565|Drug|Cetuximab|"Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
~Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations"
12024411|NCT00409565|Drug|Bevacizumab|Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
12024412|NCT00409552|Behavioral|Virtual Reality based distraction|Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
12024413|NCT00409552|Behavioral|VR with flat projection display|VR with flat projection display
12024414|NCT00409552|Behavioral|non-interactive video with head display|non-interactive video with head display
12024415|NCT00409552|Behavioral|non-interactive video with with flat projection display|non-interactive video with with flat projection display
12024416|NCT00409539|Drug|Placebo|Placebo, 2 week duration.
12024417|NCT00409539|Drug|Placebo|Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
12024418|NCT00409539|Drug|SMP-986|Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
12024421|NCT00409487|Device|Continuous positive airway pressure (CPAP)|8 weeks of CPAP
12024422|NCT00409487|Drug|Valsartant treatment|8 weeks of Valsartant treatment (160 mg / day)
12024423|NCT00409461|Drug|ATG-Sirolimus-Tacrolimus|
12024424|NCT00409448|Behavioral|Counselor-assisted problem solving (CAPS)|In CAPS, a trained counselor will guide families through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions.
12024425|NCT00409448|Behavioral|Internet-resource comparison (IRC)|Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources, but not the CAPS website content.
12024426|NCT00409435|Drug|pyridostigmine|one 180 mg capsule per day for 3 days
12024427|NCT00409435|Drug|Placebo|one capsule per day for 3 days
12024428|NCT00409422|Behavioral|weight management program|
12024429|NCT00409409|Drug|300 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
12024430|NCT00409409|Drug|Placebo tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
12024431|NCT00409396|Procedure|Urinary PGEm level|Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
12024432|NCT00409396|Procedure|fecal calprotectin|Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.
12024433|NCT00409383|Drug|Genasense® (oblimersen)|Cohorts 1 and 2: Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 7 days (Week 1) and beginning again on Day 22 and continuing for 7 days (Week 4); Cohort 3: Genasense 900 mg as a 1-hour intravenous infusion on Day 1, 4, 8, and 11 (Weeks 1 and 2) and Day 22, 25, 29, and 32 (Weeks 4 and 5).
12024434|NCT00409383|Drug|Abraxane® (paclitaxel protein-bound particles for injectable suspension)|Cohorts 1 and 2: Abraxane 175 mg/m2 or 260 mg/m2 as a 30-minute intravenous infusion on Day 8 and Day 29 following end of Genasense continuous infusion; Cohort 3: Abraxane 175 mg/m2 as a 30-minute intravenous infusion on Day 4 and Day 25 following end of Genasense 1-hour infusion
12024435|NCT00409383|Drug|Temodar® (temozolomide)|Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)
12024436|NCT00409370|Device|SOMA safe enclosure|
12024437|NCT00409357|Drug|SL77.0499-10 (alfuzosin hydrochloride)|
12024438|NCT00409344|Drug|Dexmedetomidine|A continuous infusion of dexmedetomidine will be started at a dose of 0.8mcg/kg/hr. This will continue for no longer than 24 hours. Four hours post extubation the study drug wii be discontinued using a standard tapering protocol: 0.6mcg/kg/hr for 4 hours then 0.4mcg/kg/hr for 4 hours, then 0.2 mcg/kg/hr for 4 hours and then 0.1mcg/kg/hr for 4 hours and then turned off.
12024439|NCT00409344|Other|Normal Saline|Normal Saline will be given as the placebo and will administered at 0.8mcg/kg/hr
12024440|NCT00409331|Drug|Amifostine|500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.
12024441|NCT00409331|Procedure|Intensity- Modulated Radiation Therapy|2.0 to 2.2 Gy delivered in 30 fractions
12024442|NCT00409318|Drug|Etanercept|50 mg SC q week
12024443|NCT00409318|Drug|Placebo|SC q week
12024444|NCT00409305|Drug|Betahistine|
12024445|NCT00409305|Behavioral|Dietary counseling|
12024446|NCT00409292|Drug|RAD001|Taken orally daily for as long as the participant continues to receive a benefit.
12024447|NCT00409279|Behavioral|Information, counseling and support|individual-family consultation, support group, and ad hoc consultation
12024448|NCT00409266|Device|Computer assisted navigation|
12024449|NCT00409253|Drug|URAPIDIL (EUPRESSYL*)|Urapidil (Eupressyl*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.
12024450|NCT00409253|Drug|NICARDIPINE|Nicardipine : IV 6.25 mg bolus until PAD >105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days
12024451|NCT00409240|Other|MEDIC|Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
12024452|NCT00409227|Drug|Alpha blocker-alfuzosin|P.O. alfuzosin 10 mg once a day
12024453|NCT00409227|Drug|placebo|placebo once a day for 3 months or stone free
12024454|NCT00409214|Drug|LS11 (talaporfin sodium)|
12024455|NCT00409214|Device|Light source (interstitial light emitting diodes)|
12024456|NCT00409214|Procedure|Intraoperative placement of device in glioma|
12024457|NCT00409201|Drug|reboxetine adjuvant therapy|
12024458|NCT00409188|Biological|Tecemotide (L-BLP25)|After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented.
12024459|NCT00409188|Drug|Single low dose cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination.
12024460|NCT00409188|Drug|Placebo|A single infusion (IV) of 0.9% Saline solution instead of cyclophosphamide but in the same calculated dose will be given three days before first placebo vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with placebo at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented.
12024461|NCT00409175|Drug|Fx-1006A|Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months
12024462|NCT00409175|Drug|Placebo|Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months
12024463|NCT00409162|Device|Eraser TM device, with washing fluid|
12024464|NCT00409149|Behavioral|CALM Approache|
12024465|NCT00409149|Behavioral|DASH approach|standard dietary DASH approach in hypertensive patients
12024466|NCT00409136|Behavioral|Human Alert|An alert from study staff informing a physician that his/her patient is at high risk for DVT and/or PE, but is not receiving any prophylaxis.
12024467|NCT00409097|Drug|Rosiglitazone|
12024468|NCT00409084|Procedure|endoscopic variceal band ligation|endoscopic variceal band ligation
12024469|NCT00409071|Drug|Cocculine®|12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.
12024470|NCT00409071|Drug|placebo|12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.
12024471|NCT00409058|Behavioral|Teen Online Problem Solving|We will test the following hypotheses: 1) Children with TBI receiving TOPS will have fewer behavior problems, greater social competence, and better functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 2) Caregivers of children receiving TOPS will report less depression and psychological distress, less parent-child conflict, and better family functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 3) Social resources will moderate treatment efficacy, such that children with limited social and economic resources will show greater improvements in the more comprehensive TOPS intervention. We hypothesize better teen problem solving and communication skills, fewer teen emotional/behavioral problems, less parental burden and distress, and less parent-teen conflict at follow-up among the TOPS group compared to the IRC group.
12024472|NCT00409032|Drug|Strontium malonate|
12024473|NCT00409019|Drug|Telbivudine|Study cancelled: Withdrawn before enrollment of any participants
12024474|NCT00409019|Drug|Adefovir|
12024475|NCT00409019|Drug|Tenofovir|
12024476|NCT00409006|Drug|Pemetrexed|500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.
12024477|NCT00409006|Drug|Cisplatin|75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity
12024478|NCT00409006|Drug|Gefitinib|250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity
12024479|NCT00408993|Drug|Duloxetine Hydrochloride|60 mg every day (QD) (morning or evening), by mouth (PO)
12024480|NCT00408993|Drug|Placebo|Placebo every day (QD), by mouth (PO)
12024481|NCT00408980|Behavioral|Fat and calorie controlled diet|
12024482|NCT00408967|Drug|Tucotuzumab celmoleukin (EMD 273066)|
12024483|NCT00408954|Drug|UK-369,003|100 mg MR tablet once daily for 2 weeks
12024484|NCT00408954|Drug|UK-369,003|UK-369,003-100 mg MR formulation for 2 weeks
12024485|NCT00408941|Drug|Propofol|
12024486|NCT00408941|Drug|Prilocaine|
12024487|NCT00408928|Drug|Bortezomib|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
12024488|NCT00408915|Drug|Continuous Subcutaneous Lisuride Infusion|
12024489|NCT00408902|Drug|tandutinib|Given orally, 500 mg bid daily
12024490|NCT00408902|Other|laboratory biomarker analysis|Correlative studies
12024491|NCT00408876|Drug|Duloxetine|
12024492|NCT00408876|Drug|Placebo|
12024493|NCT00408863|Drug|tibolone|tibolone 2.5 mg/day
12024494|NCT00408863|Drug|placebo|
12024495|NCT00408850|Drug|Pioglitazone|15 mg per day for 6 weeks and 30 mg per day for further 6 weeks
12024496|NCT00408850|Drug|sugar pill|One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks
12024497|NCT00408798|Drug|Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units|See Detailed Description.
12024498|NCT00408785|Drug|Botulinum Toxin Type A|botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
12024499|NCT00408785|Drug|sodium chloride|sodium chloride 0.9 mg
12024500|NCT00408772|Biological|bevacizumab|
12024501|NCT00408772|Drug|capecitabine|
12024502|NCT00408772|Drug|oxaliplatin|
12024503|NCT00408772|Procedure|conventional surgery|
12024504|NCT00408772|Procedure|neoadjuvant therapy|
12024505|NCT00408772|Procedure|radiofrequency ablation|
12024506|NCT00408759|Behavioral|hypnosis|
12024507|NCT00408746|Behavioral|palatal development|Impressions of preterm and term palates.
12024508|NCT00408733|Other|Medication Education Tool|Picture and Icon-based Customizable Educational Tool
12024509|NCT00408707|Procedure|local infiltration analgesia|
12024510|NCT00408694|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
12024511|NCT00408694|Biological|Bevacizumab|Given IV
12024512|NCT00408694|Drug|Cisplatin|Given IV
12024513|NCT00408694|Drug|Fluorouracil|Given IV
12024514|NCT00408694|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
12024515|NCT00408681|Drug|lithium carbonate|Given orally
12024516|NCT00408681|Other|laboratory biomarker analysis|Correlative studies
12024517|NCT00408668|Biological|PEV3A|
12024518|NCT00408668|Biological|FP9 ME-TRAP|
12024519|NCT00408668|Biological|MVA ME-TRAP|
12024520|NCT00408655|Drug|paclitaxel|Given IV
12024521|NCT00408655|Drug|carboplatin|Given IV
12024522|NCT00408655|Drug|temsirolimus|Given IV
12024523|NCT00408642|Behavioral|Enhanced adherence support|The enhanced adherence support intervention consists of 5 one-on-one, Information-Motivation-Behavioral Skills (IMB) theory-based counseling sessions, as well as a problem-solving card which summarizes key messages and strategies. The counseling sessions are given at key points post-initiation of therapy: at baseline, 2 weeks, 2 months, 3 months, and 6 months. Three brief weekly ART planning sessions are conducted post-initiation of therapy.
12024524|NCT00408642|Behavioral|Standard adherence support|The control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy.
12024525|NCT00408629|Biological|adalimumab|Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.
12024526|NCT00408629|Biological|placebo|Matching Placebo for prefilled syringe, 40 mg,
12024527|NCT00408616|Biological|Grazax-R|Grass tablet, 75.000 SQ per day for one year
12024528|NCT00408616|Biological|Grazax Placebo|Grazax Placebo, 0 SQ tablet per day for one year
12024734|NCT00407017|Drug|Moxifloxacin|
12024529|NCT00408603|Drug|Voreloxin Injection|All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
12024530|NCT00408590|Biological|carcinoembryonic antigen-expressing measles virus|
12024531|NCT00408590|Biological|oncolytic measles virus encoding thyroidal sodium iodide symporter|
12024532|NCT00408590|Genetic|reverse transcriptase-polymerase chain reaction|
12024533|NCT00408590|Other|laboratory biomarker analysis|
12024534|NCT00408577|Drug|L-arginine|
12024535|NCT00408564|Biological|cetuximab|
12024536|NCT00408564|Drug|capecitabine|
12024537|NCT00408564|Drug|oxaliplatin|
12024538|NCT00408564|Procedure|conventional surgery|
12024539|NCT00408564|Radiation|radiation therapy|
12024540|NCT00408564|Drug|Gemcitabine|
12024541|NCT00408551|Drug|floxuridine|Given IV
12024542|NCT00408551|Drug|fluorouracil|Given IV
12024543|NCT00408551|Drug|irinotecan hydrochloride|Given IV
12024544|NCT00408551|Drug|leucovorin calcium|Given IV
12024545|NCT00408551|Drug|oxaliplatin|Given IV
12024546|NCT00408538|Drug|UC-781 microbicide gel (0.1% and 0.25%)|
12024547|NCT00408538|Drug|placebo|
12024548|NCT00408525|Drug|donepezil|donepezil 5 mg tablets, total dose per day 10 mg for 6 week duration of study. Taken once per day.
12024549|NCT00408512|Drug|thiazides|Up to 25 mg per day
12024550|NCT00408512|Procedure|Non thiazidic treatment|Amximum tolerated dosage as indicated from the label
12024551|NCT00408499|Drug|cetuximab|Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
12024552|NCT00408499|Drug|erlotinib|Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
12024553|NCT00408473|Drug|Flecainide|
12024554|NCT00408460|Drug|imatinib mesylate|Given PO
12024555|NCT00408460|Drug|paclitaxel|Given IV
12024556|NCT00408447|Drug|Busulfan|Busulfan 4 mg/kg/d x 4d
12024557|NCT00408447|Drug|Fludarabine|Fludarabine 30 mg/m2/d x 6d
12024558|NCT00408447|Drug|Alemtuzumab|Alemtuzumab 2mg/m2 x 1d, 6mg/m2 x 2 d, 20mg/m2 x 2d
12024559|NCT00408447|Procedure|Allogeneic stem cell transplant|Allogeneic stem cells will be given on day 0 (after chemotherapy conditioning)obtained either from a family donor (first degree relative) or sibling cord blood donor.
12024560|NCT00408434|Drug|CS-7017|CS-7017 0.05mg and 1.0mg tablets
12024561|NCT00408421|Drug|Duloxetine|
12024562|NCT00408421|Drug|placebo|
12024563|NCT00408408|Biological|bevacizumab|15 mg/kg IV
12024564|NCT00408408|Drug|capecitabine|825 mg/m2 orally
12024565|NCT00408408|Drug|cyclophosphamide|600 mg/m2 IV
12024566|NCT00408408|Drug|docetaxel|100 mg/m2 IV
12024567|NCT00408408|Drug|doxorubicin hydrochloride (Adriamycin)|60 mg/m2 IV
12024568|NCT00408408|Drug|gemcitabine hydrochloride|1000 mg/m2 IV
12024569|NCT00408395|Biological|Influenza vaccine|Seasonal Influenza Vaccine
12024570|NCT00408382|Drug|atorvastatin, Lipitor|
12024571|NCT00408369|Drug|DB289|
12024572|NCT00408356|Drug|Zinc|
12024573|NCT00408330|Drug|Azelaic Acid 15% Gel|15% gel, topically applied daily for six weeks
12024574|NCT00408330|Drug|Inactive 15% gel base|placebo, topically applied daily for six weeks
12024575|NCT00408317|Drug|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
12024576|NCT00408317|Drug|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
12024577|NCT00408304|Drug|omega-3 fatty acid|
12024578|NCT00408291|Procedure|Winsta PH osteosynthesis device|The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
12024579|NCT00408278|Drug|ATRA|45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months
12024580|NCT00408278|Drug|Idarubicina|Induction: 12 mg/m2 days 2, 4, 6 and 8 Consolidation: 5 mg/m2 days 1-4 in cycle 1 and 12 mg/m2 day 1 in cycle 3.
12024581|NCT00408278|Drug|Mitoxantrone|Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2
12024582|NCT00408278|Drug|ARA-C|In high risk patients, consolidation with ara-C in cycles 1 and 3.
12024583|NCT00408265|Behavioral|Contingency Management|
12024584|NCT00408252|Other|biopsies|No intervention, only biopsy for translational project
12024585|NCT00408252|Drug|SU011248|no intervention
12024586|NCT00408239|Drug|YM150|Oral
12024587|NCT00408239|Drug|enoxaparin|Sub cutaneous
12024588|NCT00408226|Drug|MKC-1|capsules, twice daily for 14 days in 21 day cycle
12024589|NCT00408226|Drug|pemetrexed|standard dosing of 500 mg/m2 infused every 21 days
12024590|NCT00408213|Drug|mycophenolate mofetil [CellCept]|1g po bid
12024591|NCT00408213|Drug|Placebo|po bid
12024592|NCT00408200|Drug|propafenone; flecainide; sotalol; dofetilide|Above drugs prescribed per established guidelines for treatment of AF
12024593|NCT00408200|Device|Radiofrequency catheter ablation|A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
12024594|NCT00408187|Drug|voclosporin|voclosporin 0.4 mg/kg po BID
12024595|NCT00408187|Drug|Ciclosporin|ciclosporin 1.5 mg/kg po BID
12024596|NCT00408187|Drug|Placebo|Placebo
12024597|NCT00408174|Drug|Balsalazide disodium|
12024735|NCT00407017|Drug|Nepafenac|
12024598|NCT00408161|Behavioral|Contingency Management|prize contingency management (CM) -- 6-month treatment plus standard case management treatment and follow-ups at 9, 12, and 18 months after intake
12024599|NCT00408161|Behavioral|standard case management treatment|6-month treatment standard case management treatment, and follow-ups scheduled at 9, 12, and 18 months after intake.
12024600|NCT00408148|Drug|Placebo|Undistinguishable placebo tablets
12024601|NCT00408148|Drug|Rimonabant|White film-coated, for oral administration containing 20 mg of active rimonabant
12024602|NCT00408135|Drug|telithromycin (HMR3647)|
12024603|NCT00408122|Procedure|PET/CT scan and EUS|
12024604|NCT00408109|Drug|VRC-AVIDNA036-00-VP|
12024605|NCT00408096|Procedure|Copeland or Global CAP resurfacing prosthesis|Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
12024606|NCT00408083|Drug|MultiHance|0.5 mmol/kg as a single dose administration
12024607|NCT00408083|Drug|Magnevist|0.5 mmol/kg as a single dose administration
12024608|NCT00408070|Drug|Bevacizumab|cycle 2 (6 cycles re-evaluated and follow up)
12024609|NCT00408070|Drug|Carboplatin|cycle #1 and continuous through entire regimen; treated every 3 weeks
12024610|NCT00408070|Drug|Paclitaxel|cycle #1 and continuous through entire regimen; treated every 3 weeks
12024611|NCT00408057|Other|no intervention|no intervenion
12024612|NCT00408044|Procedure|cardiac surgery with sternotomy|
12024613|NCT00408031|Drug|D-cycloserine|D-cycloserine (DCS , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against tuberculosis, that acts as a partial agonist at the NMDAR-associated GLY site.
12024614|NCT00408018|Drug|P276-00|Potent Cyclin dependent kinase (cdk) cdk4 D1, cdk1 B and cdk9 T inhibitor
12024615|NCT00408005|Drug|Asparaginase|Given IM or IV
12024616|NCT00408005|Drug|Cyclophosphamide|Given IV
12024617|NCT00408005|Drug|Cytarabine|Given IT, IV, or SC
12024618|NCT00408005|Drug|Daunorubicin Hydrochloride|Given IV
12024619|NCT00408005|Drug|Dexamethasone|Given IV or PO
12024620|NCT00408005|Drug|Doxorubicin Hydrochloride|Given IV
12024621|NCT00408005|Other|Laboratory Biomarker Analysis|Correlative studies
12024622|NCT00408005|Drug|Leucovorin Calcium|Given PO
12024623|NCT00408005|Drug|Mercaptopurine|Given PO
12024624|NCT00408005|Drug|Methotrexate|Given IT or PO
12024625|NCT00408005|Drug|Nelarabine|Given IV
12024626|NCT00408005|Drug|Pegaspargase|Given IM or IV
12024627|NCT00408005|Drug|Prednisone|Given IV or PO
12024628|NCT00408005|Radiation|Radiation Therapy|Some patients undergo testicular and/or prophylactic cranial RT
12024629|NCT00408005|Drug|Thioguanine|Given PO
12024630|NCT00408005|Drug|Vincristine Sulfate|Given IV
12024631|NCT00407992|Device|Occipital nerve stimulation ON|Implant of an occipital nerve stimulator switched ON
12024632|NCT00407992|Device|Occipital nerve stimulation off|Implant of an occipital nerve stimulator switched OFF
12024633|NCT00407966|Drug|alvocidib|Given IV
12024634|NCT00407966|Drug|cytarabine|Given IV
12024635|NCT00407966|Drug|mitoxantrone hydrochloride|Given IV
12024636|NCT00407940|Device|Lower extremity Atherectomy and Cryoplasty|
12024637|NCT00407927|Drug|Epinastine Nasal Spray|
12024638|NCT00407914|Device|Aquamid|Subcutaneous injection
12024639|NCT00407914|Device|Restylane|Injection in dermis
12024640|NCT00407888|Drug|doxorubicin hydrochloride|Given IV
12024641|NCT00407888|Drug|cyclophosphamide|Given orally
12024642|NCT00407888|Biological|filgrastim|Given SC
12024643|NCT00407888|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
12024644|NCT00407888|Biological|trastuzumab|Given IV
12024645|NCT00407888|Other|laboratory biomarker analysis|Correlative studies
12024646|NCT00407888|Procedure|quality-of-life assessment|Ancillary studies
12024647|NCT00407875|Procedure|Intensity Modulated External Beam Radiation Therapy|
12024648|NCT00407862|Drug|Telmisartan 80 mg|
12024649|NCT00407862|Drug|Losartan 50 mg|
12024650|NCT00407849|Drug|triamcinolone acetonide|Intravitreal injection
12024651|NCT00407836|Biological|T cell vaccination|Approximately 10-20 million glutaraldehyde fixed CD4 responsive autologous T cells in 1-2 ml, per vaccine injection.
12024652|NCT00407836|Biological|T cell vaccination|Approximately 10-20 million autologous CD4 reactive T cells per each vaccine injection
12024653|NCT00407823|Procedure|Central venous oxygen saturation continuous monitoring|
12024654|NCT00407797|Drug|Pregabalin|150 to 600 mg/day during 21 weeks
12024655|NCT00407784|Drug|eplerenone|
12024656|NCT00407771|Drug|Tirofiban|
12024657|NCT00407758|Drug|enzastaurin hydrochloride|
12024658|NCT00407745|Drug|placebo|Placebo
12024659|NCT00407745|Drug|pregabalin|Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
12024660|NCT00407732|Behavioral|psychosocial intervention|motivational enhancing case management intervention
12024661|NCT00407719|Drug|Bevacizumab|
12024662|NCT00407706|Procedure|blood test|
12024663|NCT00407693|Drug|[C-11]PRB28|
12024664|NCT00407680|Drug|Intensive therapy Valsartan,Fluvastatin|
12024665|NCT00407667|Device|transcranial galvanic stimulation|for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin
12024666|NCT00407654|Drug|aflibercept|Given intravenously
12024667|NCT00407641|Drug|Tinzaparin administration|Patients will receive tinzaparin during the HD session
12024668|NCT00407641|Drug|Heparin administration|Patients will receive Heparin as an anticoagulant during the HD session.
12024669|NCT00407615|Device|Flex Pad/Static Magnet|
12024670|NCT00407602|Device|Argus II Retinal Stimulation System|epiretinal implantation of device
12024671|NCT00407589|Drug|BOL-303224-A|1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).
12024672|NCT00407576|Drug|[11C]MeS-IMPY|
12024673|NCT00407563|Drug|Bevacizumab|Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.
12024736|NCT00407017|Drug|EconoPred Plus|
12024674|NCT00407563|Drug|Abraxane|Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
12024675|NCT00407550|Drug|gemcitabine HCL|1250 mg/m^2 administered through 250 cc NS (normal saline) IV (intravenous) infusion over 30 minutes at days 1 & 8 of each cycle (21 days) x6 cycles.
12024676|NCT00407550|Drug|pemetrexed disodium|500 mg/m^2 administered through 100 mL NS IV infusion over 10 minutes at day 1 of each cycle.
12024677|NCT00407550|Drug|gemcitabine HCL|1500 mg/m^2 administered through 250 cc NS IV infusion over 30 minutes at days 1 of each cycle (14 days) x9 cycles.
12024678|NCT00407537|Drug|Amlodipine besylate/atorvastatin calcium single pill combination|Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
12024679|NCT00407524|Drug|AKL 1|
12024680|NCT00407511|Drug|Pregabalin|Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).
12024681|NCT00407498|Drug|P276-00|Starting dose of 9 mg/m2/day from day 1to 5 and day 8 to 12 in 21 day cycle.Protocol wa amended to dose the subjects for day 1 to5 in 21 day cycle after 34.4 mg/m2/day cohort.Maximum dose administered was 259 mg/m2/day
12024682|NCT00407485|Biological|ziv-aflibercept|Given IV
12024683|NCT00407485|Other|pharmacological study|Correlative studies
12024684|NCT00407472|Device|ATS-1 needle free device|
12024685|NCT00407459|Drug|Bevacizumab, Pemetrexed, Carboplatin|"Bevacizumab: 15 mg/kg intravenous infusion over 30 to 90 minutes, following chemotherapy, on Day 1 every 3 weeks
~Pemetrexed: 500 mg/m2 intravenous infusion over 10 minutes on Day 1 every 3 weeks
~Carboplatin: AUC 5 intravenous infusion over 1 hour on Day 1 every 3 weeks"
12024686|NCT00407446|Drug|sildenafil|
12024687|NCT00407433|Drug|Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)|
12024688|NCT00407420|Device|Mandometer|A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy.
12024689|NCT00407420|Behavioral|Lifestyle|Typical dietary and activity advice as normally provided in clinic (control).
12024690|NCT00407407|Drug|ABI-007|80mg/m^2 to 150mg/m^2 IV every 3 weeks
12024691|NCT00407407|Drug|Carboplatin|6 AUC IV every 3 weeks on the same day as ABI-007
12024692|NCT00407394|Drug|Amoxycillin|
12024693|NCT00407381|Drug|Ranibizumab|Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.
12024694|NCT00407381|Procedure|Laser photocoagulation|Laser photocoagulation in either focal or grid pattern as determined by investigator.
12024695|NCT00407368|Procedure|Blood Sample|
12024696|NCT00407355|Drug|Intravitreal injection of ranibizumab .3 dose|PRN every 30 days withing retreatment criteria
12024697|NCT00407355|Drug|Intravitreal injection of Ranibizumab .5 dose|Intravitreal injection of Ranibizumab .5 dose every 30 days PRN with retreatment criteria
12024698|NCT00407342|Drug|Alefacept (drug)|alefaceptgiven iv
12024699|NCT00407342|Procedure|Narrowband UVB phototherapy|
12024700|NCT00407329|Procedure|transurethral resection of the prostate|resection of prostate
12024701|NCT00407303|Drug|Obatoclax mesylate|30 mg, 45 mg
12024702|NCT00407303|Drug|Bortezomib|1.0mg/m2, 1.3 mg/m2
12024703|NCT00407290|Drug|neostigmine|
12024704|NCT00407277|Drug|Nicotine patch|21 mg of nicotine via a dermal patch
12024705|NCT00407277|Other|placebo|placebo via a dermal patch
12024706|NCT00407277|Behavioral|smoking cessation group therapy|"a 9-week group based on the Freedom From Smoking program designed by the American Lung Association. The treatment was manualized and modified to meet the functional and cognitive capabilities of patients with psychotic disorders"
12024707|NCT00407264|Drug|Fluticasone propionate|
12024708|NCT00407251|Drug|Patupilone|
12024709|NCT00407238|Device|Multi-purpose solutions (polyquaternium-1 and PHMB)|
12024710|NCT00407225|Drug|Difluprednate Ophthalmic Emulsion|
12024711|NCT00407212|Drug|TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)|
12024712|NCT00407199|Drug|quetiapine|
12024713|NCT00407186|Drug|cisplatin+capecitabine|cisplatin 20 mg/m2 (i.v., q 1 w, 5 weeks), capecitabine 575 mg/m2 (b.i.d., oral, on radiotherapy days.
12024714|NCT00407186|Radiation|radiotherapy|45 Gy in 25 fracions (5 days/week)
12024715|NCT00407186|Drug|epirubicin+cisplatin+capecitabine|3 courses q 3 w: epirubicin 50 mg/m2 (i.v., day 1), cisplatin 60 mg/m2 (i.v., day 1), capecitabine 1000 mg/m2 (b.i.d., oral, day 1-14)
12024716|NCT00407173|Drug|HCV-796|HCV-796 1000mg single dose
12024717|NCT00407147|Device|Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor|"antibiotic treatment based on clinical decision making with traditional thought processes used in both groups. In addition the physician will be given access to Procalcitonin values with recommended thresholds for likelihood of infection."
12024718|NCT00407134|Procedure|Different abdominal volumes and different glucose-concentrations during peritoneal dialysis|
12024719|NCT00407121|Drug|Bevacizumab|
12024720|NCT00407121|Procedure|Intravitreal Injection of Bevacizumab|
12024721|NCT00407108|Procedure|Vitrectomy|
12024722|NCT00407095|Drug|Pardoprunox|12-42 mg/day
12024723|NCT00407082|Drug|fluocinolone acetonide intravitreal implant|Fluocinolone acetonide ocular implant 0.59mg
12024724|NCT00407082|Drug|Fluocinolone acetonide 2.1mg|Fluocinolone acetonide ocular implant 2.1mg
12024725|NCT00407056|Drug|Difluprednate Ophthalmic Emulsion|
12024726|NCT00407043|Drug|Lotemax|
12024727|NCT00407043|Drug|Restasis|
12024728|NCT00407030|Drug|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (240 Units)"
12024729|NCT00407030|Drug|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (120 Units)"
12024730|NCT00407030|Drug|Placebo|Placebo
12024731|NCT00407017|Drug|Gatifloxacin|
12024732|NCT00407017|Drug|Ketorolac LS|
12024733|NCT00407017|Drug|Pred Forte|
12024737|NCT00407004|Device|MARS (Molecular Adsorbents Recirculating System)|
12024738|NCT00407004|Device|Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)|
12024739|NCT00406991|Drug|aspirin|
12024740|NCT00406991|Drug|clopidogrel|
12024741|NCT00406978|Drug|Prednisone|Prednisone will be given orally at the dose of 1.5 mg/Kg for 4 days followed by a 31-day rest period (days 5 through 35)
12024742|NCT00406978|Drug|Melphalan|Melphalan will be given orally at the dose of 0.25 mg/Kg for 4 days,
12024743|NCT00406978|Drug|Thalidomide|Thalidomide will be administered orally at the initial dose of 50 mg/day p.o. once daily, with increment of 50 mg after a month to acceptable tolerance (maximum 100 mg), continuously for the entire 6 courses.
12024744|NCT00406978|Drug|Defibrotide|Lev - 1 Def = 10 mg/Kg (max 0.6 g) on days 1-4, followed by 1.2 g (400 mg every 8 hours) p.o. through day 35 Lev - 1 Def = 1.2 g p.o (400 mg every 8 hours) on days 1-4, followed by 1.2 g (400 mg every 8 hours) p.o. through day 35 Level + 1 Def = 17 mg/Kg (max 1.2 g) on days 1-4, followed by 1.6 g p.o. (400 mg every 6 hours) through day 35 Lev + 1 Def = 2.4 g p.o. (400 mg every 4 hours) on days 1-4, followed by 1.6 g p.o. (400 mg every 6 hours) through day 35 Lev + 2 Def = 34 mg/Kg (max 2.4 g) as a i.v. injection on days 1-4, followed by 3.2 g p.o. (800 mg every 6 hours) through day 35 Lev + 2 Def = 4.8 g p.o. (800 mg every 4 hours) on days 1-4, followed by 3.2 g p.o. (800 mg every 6 hours) through day 35 Lev + 3 Def = 51mg/Kg (max 3.6 g) as a i.v. injection on days 1-4, followed by 4.8 g p.o. (1200 mg every 6 hours) through day 35 Lev + 3 Def = 7.2 g p.o.(1200 mg every 4 hours ) on days 1-4, followed by 4.8 g p.o. (1200 mg every 6 hours) given p.o. through day 35
12024745|NCT00406965|Drug|HAE1 (PRO98498)|
12024746|NCT00406952|Procedure|electronic diary|
12024747|NCT00406952|Drug|Sertraline|
12024748|NCT00406952|Drug|Placebo|
12024749|NCT00406952|Procedure|voice acoustics|
12024750|NCT00406939|Genetic|IL-12 gene|
12024751|NCT00406926|Drug|Somatropin|
12024752|NCT00406913|Drug|mupirocin ointment|
12024753|NCT00406913|Other|SOC sterilization|
12024754|NCT00406900|Procedure|Treatment of metastatic disease|
12024755|NCT00406887|Drug|Difluprednate Ophthalmic Emulsion|
12024756|NCT00406874|Drug|omega 3 fats|1,000 mg daily
12024757|NCT00406874|Drug|folic acid|800 micrograms daily
12024758|NCT00406861|Drug|montelukast in treatment of ENL reaction|
12024759|NCT00406848|Drug|duloxetine hydrochloride|Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
12024760|NCT00406848|Drug|placebo|Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
12024761|NCT00406835|Procedure|Whole-Brain Radiation Therapy, Stereotactic Radiosurgery|
12024762|NCT00406822|Device|OculusGen Biodegradable Collagen Matrix Implant|
12024763|NCT00406809|Drug|ABT-263|"Oral solution
~Phase 1 dosing was under two different schedules: 14 days on drug, 7 days off or 21 days continuous dosing.
~Oral solution and tablets
~Phase 2a dosing under 21 day continuous dosing.
~- 150 mg lead-in dose for 7-14 days followed by a 325 mg continuous once daily dose."
12024764|NCT00406796|Drug|Ranibizumab|0.3mg and 0.5mg dose of Ranibizumab 0.05ml administered intravitreally
12024765|NCT00406783|Drug|5-mg Desloratadine|5-mg Desloratadine tablet, once daily for 15 days
12024766|NCT00406783|Drug|Placebo|Placebo tablet, once daily for 15 days
12024767|NCT00406770|Device|Light therapy|
12024768|NCT00406757|Drug|Nelarabine injection 400mg/m2|"Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5.
~Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5."
12024769|NCT00406757|Drug|Nelarabine injection 650mg/m2|Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.
12024770|NCT00406757|Drug|Nelarabine injection 1000mg/m2|"Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5.
~Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5."
12024771|NCT00406757|Drug|Nelarabine injection 1500mg/m2|Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.
12024772|NCT00406744|Drug|Intravitreal injection of Bevacizumab|
12024773|NCT00406731|Drug|NG-monomethyl-L-arginine (L-NMMA)|bolus 6 mg/kg over 5 minutes followed by a continuous intravenous infusion of 60 µg/kg/min over 12 minutes; twice on 1 study day
12024774|NCT00406731|Drug|Endothelin-1 (ET-1)|5 ng/kg/min intravenous infusion over 17 minutes; twice on 1 study day
12024775|NCT00406731|Drug|Physiologic saline solution (placebo control)|intravenous infusion over 20 minutes; twice on 1 study day
12024776|NCT00406731|Device|Laser Doppler flowmetry|blood flow measurements at the temporal neuroretinal rim of the optic nerve head
12024777|NCT00406731|Device|Goldmann applanation tonometer|Intraocular pressure measurements
12024778|NCT00406731|Device|HP-CMS patient monitor|blood pressure and pulse rate measurements
12024779|NCT00406731|Procedure|Suction cup method|The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
12024780|NCT00406718|Behavioral|Med-eMonitor|Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
12024781|NCT00406718|Behavioral|PharmCAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
12024782|NCT00406718|Behavioral|Treatment as Usual|Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
12024783|NCT00406705|Behavioral|Helium-Hyperoxia|
12024784|NCT00406692|Drug|Zonisamide|Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily.
12024785|NCT00406679|Drug|Paracetamol (acetaminophen) solution experimental|1 gm IV
12024786|NCT00406679|Drug|paracetamol (acetaminophen) solution commercial|1 gm IV
12024787|NCT00406679|Drug|placebo|equivalent volume IV 0.9% sodium chloride (equivalent volume)
12024788|NCT00406653|Drug|abatacept|"Dextrose 5% in water, intravenous (IV).
~Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;
~3 mg/kg on days IP-1, IP-15,IP-29, IP-57;
~~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,
~or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57.
~Induction Period 3 months
~Maintenance Period 12 months"
12024789|NCT00406653|Drug|placebo|"Normal saline, IV, 0 mg/kg, every 28 days.
~Induction Period 3 months
~Maintenance Period 12 months"
12024790|NCT00406653|Drug|abatacept|"~10 mg/kg, every 28 days.
~Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued"
12024791|NCT00406640|Drug|Desvenlafaxine succinate sustained-release (DVS SR)|flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.
12024792|NCT00406640|Drug|Escitalopram|Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.
12024793|NCT00406614|Behavioral|Health Literacy-Focused High Blood Pressure Intervention|Participants assigned to the intervention group will attend a weekly 2-hour educational session for 6 weeks that will cover topics such as learning medical terminology, understanding the content of prescription and appointment slips, and blood pressure (BP) management strategies. Upon completion of the educational sessions, participants will submit BP measurements via telephone monitoring system for 12 months and Community Health Worker (CHW) will conduct telephone counseling once every month during the same 12-month period for support and follow-up counseling. Participants will continue to monitor BP measurement by logging BP data on BP diary book for another 12 months. Control group participants will receive the same intervention education following the completion of the study.
12024794|NCT00406601|Drug|Sorafenib (BAY-43-9006)|800 mg/die orally on a continuous basis
12024795|NCT00406588|Drug|Levodopa (Pardoprunox)|12-42mg
12024796|NCT00406588|Drug|Placebo Comparator|Placebo
12024797|NCT00406575|Drug|Placebo|Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
12024798|NCT00406575|Drug|Recombinant human relaxin (rhRlx)|Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
12024799|NCT00406562|Biological|Boostrix|
12024800|NCT00406536|Dietary Supplement|Lym-X-Sorb powder|Lym-X-Sorb is an organized matrix of lyso phosphatidylcholine (LPC), free fatty acid (FFA) and monoglyceride formulated at 20wt% with flour and sugar. A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.
12024801|NCT00406536|Dietary Supplement|Placebo powder|The placebo is composed of soybean oil, sunflower oil, fully hydrogenated cottonseed oil and flax seed oil dispersed at 16wt% on flour and sugar. The placebo is >99% triglycerides with no trans fatty acids. The fatty acid composition and caloric content is designed to match the active supplement (Lym-X-Sorb). A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.
12024802|NCT00406523|Device|JANUS Stent|
12024803|NCT00406510|Drug|Optive, Systane|
12024804|NCT00406497|Drug|Difluprednate Ophthalmic Emulsion|
12024805|NCT00406484|Behavioral|Standard drug counseling|Individual drug counseling
12024806|NCT00406484|Behavioral|BDRC|Behavioral Drug and HIV Risk Reduction Counseling, individual once or twice weekly sessions
12024807|NCT00406471|Drug|Ranibizumab (Lucentis)|500 microgram intravitreal injection for 8 months or 300 microgram intravitreal injection for 8 months
12024808|NCT00406458|Drug|SB-509|60 mg dose
12024809|NCT00406458|Other|Normal Saline|
12024810|NCT00406432|Drug|Paroxetine Controlled Release Tablet|Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.
12024811|NCT00406419|Drug|Methotrexate|Methotrexate tablet was administered orally at a dose 7.5-25 mg
12024812|NCT00406419|Drug|ocrelizumab|Ocrelizumab was administered via IV infusion at a dose specified in arm description
12024813|NCT00406419|Drug|Placebo|Matching placebo to ocrelizumab was administered via IV infusion
12024814|NCT00406406|Drug|SKI-606|
12024815|NCT00406393|Drug|Tacrolimus|"Adults and Children: Tacrolimus will be given at a dose of 0.02 mg/kg every 24 hours as a continuous intravenous infusion beginning on Day -3. An effort will be made to convert the tacrolimus to oral dosing at 2-3 times the total 24-hour intravenous dose, split into 2 doses given every 12 hours as soon as clinically feasible.
~The target serum level for tacrolimus is 5-10 ng/mL."
12024816|NCT00406393|Drug|Methotrexate|Methotrexate will be given at a dose of 15 mg/m2 on Day 1 after transplantation, and at a dose of 10 mg/m2 on Days 3, 6 and 11 after transplantation.
12024817|NCT00406393|Drug|Sirolimus|"Adults: Sirolimus will be given in a loading dose of 12 mg on Day -3 followed by a daily oral dose of 4 mg per day. Doses may be repeated if the subject vomits within 15 minutes of an oral dose.
~Children: Children aged < 12.0 years OR weighing < 40.0 kg will be given an oral loading dose of sirolimus of 3 mg/m2 followed by a daily oral dose of 1 mg/m2, rounded to the nearest full milligram.
~The target serum level for sirolimus is 3-12 ng/mL."
12024818|NCT00406380|Drug|Bevacizumab|
12024819|NCT00406380|Procedure|Intravitreal injection of Bevacizumab|
12024820|NCT00406367|Drug|incobotulinumtoxinA (Xeomin)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection"
12024880|NCT00405873|Drug|AMT2003|
12024881|NCT00405860|Drug|CellCept (mycophenolate mofetil)|
12024882|NCT00405847|Drug|Dexmedetomidine|
12024821|NCT00406367|Drug|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
12024822|NCT00406354|Drug|Atomoxetine|Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.
12024823|NCT00406354|Drug|Placebo|Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.
12024824|NCT00406341|Drug|Difluprednate Ophthalmic Emulsion|
12024825|NCT00406315|Drug|ziprasidone|Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
12024826|NCT00406302|Drug|Docetaxel|75mg/m², day 1,22
12024827|NCT00406302|Drug|oxaliplatin|40mg/m², d1,2,22,23
12024828|NCT00406302|Drug|cetuximab|400mg/m² (day1), 250mg/m² (day 8,15,22,29,36)
12024829|NCT00406302|Procedure|surgery|28 days after end of induction chemotherapy
12024830|NCT00406289|Procedure|18F-FDG-PET radiotherapy|
12024831|NCT00406276|Drug|RAD001|RAD001 will be given at a dose of 5mg/day in combination with docetaxel
12024832|NCT00406276|Drug|Docetaxel|In combination with RAD001
12024833|NCT00406263|Procedure|Scheimpflug crystalline lens photographs|scheimpflug photographs
12024834|NCT00406250|Drug|intravitreal injection|1.25 mg in 0.05 cc of bevacizumab
12024835|NCT00406250|Drug|intravitreal injection|1.25 mg of bevacizumab intravitreally injected in a steril field
12024836|NCT00406237|Drug|tigecycline|Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion
12024837|NCT00406224|Drug|breathing 100% oxygen|
12024838|NCT00406211|Biological|MMRV|
12024839|NCT00406211|Biological|MMR (Priorix®)|
12024840|NCT00406211|Biological|Varicella (Varilrix®)|
12024841|NCT00406198|Procedure|venovenous hemofiltration|
12024842|NCT00406172|Drug|Bevacizumab|
12024843|NCT00406159|Device|Hyperbaric Oxygen Therapy|
12024844|NCT00406146|Drug|amodiaquine+artesunate/artemether-lumefantrine|
12024845|NCT00406133|Device|Continuous glucose monitor|Daily use of a continuous glucose monitor
12024846|NCT00406120|Procedure|Fine needle aspiration biopsy|
12024847|NCT00406107|Drug|pegaptanib sodium (Macugen)|Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3mg or 1mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48.
12024848|NCT00406094|Drug|montelukast|10mg
12024849|NCT00406094|Drug|placebo|placebo
12024850|NCT00406068|Drug|Mycobacterial cell wall-DNA complex|8 mg MCC, intravesical - Induction Phase (6 weekly intravesical instillations) and Maintenance Phase (3 weekly instillations at months 3, 6, 12, 18 and 24).
12024851|NCT00406055|Device|RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6|Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.
12024852|NCT00406042|Drug|prednisolone acetate 1%|
12024853|NCT00406029|Drug|Preladenant|1 mg BID capsules
12024854|NCT00406029|Drug|Preladenant|2 mg BID capsules
12024855|NCT00406029|Drug|Preladenant|5 mg BID capsules
12024856|NCT00406029|Drug|Preladenant|10 mg BID capsules
12024857|NCT00406029|Drug|Placebo|BID capsules
12024858|NCT00406029|Drug|L-dopa|Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).
12024859|NCT00406029|Drug|Other Parkinson's Disease treatments|Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.
12024860|NCT00406016|Drug|ATI355|
12024861|NCT00406003|Drug|Paroxetine controlled release tablet|Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.
12024862|NCT00405990|Behavioral|Voluntary counselling and HIV testing in ANC for PMTCT|VCT for 30 minutes in ANC
12024863|NCT00405990|Behavioral|VCT|HIV VCT for PMTCT
12024864|NCT00405977|Drug|Physiologic saline|Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group and 1 ml per kg physiological saline. The infusion will be given with during 15 minutes.
12024865|NCT00405977|Drug|Magnesium sulphate|Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group. The infusion will be given during 15 minutes.
12024866|NCT00405964|Drug|5-mg Desloratadine|5-mg Desloratadine tablet, once daily for 12 weeks
12024867|NCT00405964|Drug|Placebo tablet|Placebo tablet, once daily for 12 weeks
12024868|NCT00405951|Drug|Obatoclax mesylate 250 ml|
12024869|NCT00405951|Drug|Docetaxel|
12024870|NCT00405938|Drug|Bevacizumab|Bevacizumab 10mg/kg IV every 2 weeks
12024871|NCT00405938|Drug|Anastrozole|anastrozole (1 mg orally daily)
12024872|NCT00405938|Drug|Fulvestrant|fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant).
12024873|NCT00405925|Drug|Trizivir|
12024874|NCT00405925|Drug|zidovudine,lamivudine,abacavir|zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid
12024875|NCT00405912|Drug|Placebo|Placebo (inactive drug) given 3 times per day
12024876|NCT00405912|Drug|St. John's Wort-900 mg/day|St. John's Wort - 300 mg tables -3 times per day
12024877|NCT00405912|Drug|St. John's Wort-1800mg/day|St. John's Wort - 600 mg tables - 3 times per day
12024878|NCT00405886|Drug|Neramexane|Oral tablets, duration: 16 weeks
12024879|NCT00405886|Drug|Placebo|Oral tablets, duration: 16 weeks
12024883|NCT00405834|Device|Envision® Patient Support System|
12024884|NCT00405821|Drug|Acyclovir|400mg twice daily for 24 months
12024885|NCT00405821|Drug|Placebo|Placebo tablet twice daily for 24 months
12024886|NCT00405808|Drug|Rimonabant|Once daily in the morning
12024887|NCT00405808|Drug|Placebo|Once daily in the morning
12024888|NCT00405795|Device|Envision® Patient Support System|
12024889|NCT00405782|Behavioral|Moderate-Intensity Exercise|Exercise program designed by exercise physiologist
12024890|NCT00405769|Drug|red yeast rice|600 mg 3 caps bid
12024891|NCT00405769|Drug|placebo|3 caps bid
12024892|NCT00405756|Drug|Lenalidomide: Double-blind Induction|Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
12024893|NCT00405756|Drug|Melphalan|Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
12024894|NCT00405756|Drug|Prednisone|Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
12024895|NCT00405756|Drug|Aspirin|"Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.
~Double-blind maintenance: at the investigator's discretion"
12024896|NCT00405756|Drug|Placebo|"Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles.
~Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression."
12024897|NCT00405756|Drug|Lenalidomide: Double-blind Maintenance|Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.
12024898|NCT00405756|Drug|Lenalidomide: Open-label|Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.
12024899|NCT00405743|Drug|CP-4055|CP-4055 Continuous IV infusion
12024900|NCT00405743|Drug|CP-4055|CP4055 2 and 4 hour IV infusion
12024901|NCT00405730|Drug|Nepafenac 1mg/ml eye drops, suspension|One drop in the study eye 3 times daily for 23 days
12024902|NCT00405730|Drug|Ketorolac Trometamol 5 mg/ml eye drops, solution|One drop in the study eye 3 times daily for 23 days
12024903|NCT00405730|Other|Nepafenac vehicle eye drops|One drop in the study eye 3 times daily for 23 days
12024904|NCT00405717|Drug|atorvastatin,pravastatin|
12024905|NCT00405704|Drug|Trimethoprim-Sulfamethoxazole|Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
12024906|NCT00405704|Drug|Placebo|Cherry flavored liquid suspension matched to active comparator.
12024907|NCT00405691|Device|"TOPS System - Total Posterior Arthroplasty Implant"|
12024908|NCT00405678|Behavioral|Exercise Training|Subjects receiving chemo with exercise training
12024909|NCT00405678|Behavioral|Chemo only|Subjects receiving chemo only
12024910|NCT00405665|Drug|L-arginine|Group 1 will receive the active treatment followed by the inactive treatment. The active treatment phase will consist of L-arginine 250 mg/ml dispensed in 2.2 ml vials, from which the patient will take 2ml (500mg) and dilute with 3ml of sterile water to give 5ml of a 100mg/ml solution. Dosing in the inactive treatment phase will consist of a placebo of similar osmolarity and appearance will be formulated and dosed in a similar fashion. It will consist of 2.2ml vials of 1110mmol/L hypertonic saline. Again, the patient will take 2ml and dilute with 3ml of sterile water to give a 445mmol/L solution which has similar tonicity (10%) to the L-arginine. Both treatment phases will be administered by inhalation with a PARI eFLOW device.
12024911|NCT00405665|Drug|L-arginine|Group 2 will receive the inactive treatment followed by the active treatment.
12024912|NCT00405652|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|experimental
12024913|NCT00405639|Drug|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
12024914|NCT00405639|Drug|Placebo|Normal saline will be used for placebo.
12024915|NCT00405626|Drug|Bellis Perenis ,Arnica montana|
12024916|NCT00405613|Drug|Aspirin|
12024917|NCT00405600|Procedure|Device used in surgery with or without instrumentation|Infuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented.
12024918|NCT00405587|Drug|PLX4032|Oral capsules administered BID
12024919|NCT00405574|Drug|ATN-224|ATN-224 high dose: 300mg ATN-224 low dose: 30mg
12024920|NCT00405561|Drug|AMT2003|
12024921|NCT00405548|Drug|BNP (nesiritide)|
12024922|NCT00405548|Drug|Placebo|
12024923|NCT00405535|Drug|glycine|
12024924|NCT00405535|Other|placebo|
12024925|NCT00405522|Drug|Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg|Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
12024926|NCT00405522|Drug|Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg|Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
12024927|NCT00405496|Drug|Difluprednate Ophthalmic Emulsion|
12024928|NCT00405483|Procedure|Standard exposure|Minimal invasive vs standard exposure of the joint is the difference between a small incision, smaller equipment for less tissue damage vs large incision (standard is greater than 10cm)and subsequent more tissue damage.
12024929|NCT00405483|Procedure|Minimally Invasive|Minimally invasive surgical technique (minimal incision)
12024930|NCT00405470|Device|Advance Medial Pivot Knee Arthroplasty|medial pivot total knee arthroplasty tibial component vs standard posterior stabilized tibial component with post. Medial pivot provides a constrained medial condyle through shape of polyethylene and reduces amount of bone removal on femoral side that would otherwise be removed to accommodate PS post
12024931|NCT00405457|Drug|Restasis, Optive Tears|Restasis and Optive Tears use twice daily more frequently if needed
12024932|NCT00405444|Drug|Fentanyl|The dose of fentanyl that each child will receive will be 2 mcg/kg based on the child's weight. The medication will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.
12024933|NCT00405444|Drug|Sterile water|The dose of sterile water that each child will receive will be 2 mcg/kg based on the child's weight. It will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.
12024934|NCT00405431|Drug|Restasis|1 drop in study eye twice a day X 6 months
12024935|NCT00405431|Drug|Endura (artificial tears)|1 drop in study eye twice a day X 6 months
12024936|NCT00405418|Drug|Insulin glargine|Subcutaneous injection, once a day in the evening
12024937|NCT00405418|Drug|Insulin Detemir|Subcutaneous injection, twice a day at breakfast and before dinner
12024938|NCT00405405|Drug|Cisplatin|"Two cycles during neoadjuvant therapy
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
12024939|NCT00405405|Drug|Docetaxel|"Two cycles during neoadjuvant therapy
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
12024940|NCT00405405|Drug|Bevacizumab|"Two cycles during neoadjuvant therapy
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
12024941|NCT00405405|Drug|Erlotinib|"Two cycles during neoadjuvant therapy (dose escalation)
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
12024942|NCT00405405|Radiation|Radiotherapy|Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
12024943|NCT00405392|Drug|Ibandronate (SB743830HD)|
12024944|NCT00405379|Device|Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty|new porous metal tibial component with potential to result in improved bone in-growth and implant integration with proximal tibia
12024945|NCT00405366|Drug|sorafenib tosylate|Patients will receive treatment with 400mg of sorafenib, orally, twice daily, on a continuous basis as a single agent for at least 4 weeks, but not more than 8 weeks prior to their scheduled nephrectomy
12024946|NCT00405353|Drug|Androgel 10 grams of gel containing 100 mg of testosterone|testosterone gel
12024947|NCT00405340|Drug|Rituximab|Patients will received rituximab 4 weekly doses of rituximab 375 mg/m2 at baseline. Patients will be retreated at 6 months.
12024948|NCT00405327|Biological|Tumor lysate-pulsed dendritic cell (DC) vaccine|Tumor lysate-pulsed dendritic cell vaccine
12024949|NCT00405327|Other|Hematopoietic stem cell transplantation (HSCT)|Hematopoietic stem cell transplantation (HSCT)
12024950|NCT00405314|Device|Continuous positive airway pressure ventilation mask|
12024951|NCT00405301|Drug|Rifampicin(max dose 10 mg/kg/day), Isoniazide (max dose 5 mg/kg/day) and Pyrazinamide (max dose 25 mg/kg/day)|Patients who develop ATT drug induced hepatotoxicity will be divided into 3 arms .Arm 1,2,3 will be given drugs as described in detailed description of the title.
12024952|NCT00405288|Drug|Proctofoam-HC®|Observational study of the exposure to Proctofoam-HC®
12024953|NCT00405275|Drug|Etanercept|etanercept, subcutaneous injection
12024954|NCT00405275|Drug|methotrexate|baseline methotrexate is maintained throughout the study and is not provided by the sponsor
12024955|NCT00405275|Drug|Sulfasalazine|sulfasalazine, oral
12024956|NCT00405275|Drug|Hydroxychloroquine|hydroxychloroquine, oral
12024957|NCT00405275|Drug|Placebo, triple|Participants in Etanercept arm (Arm 1) were given placebo hydroxychloroquine and sulfasalazine pills.
12024958|NCT00405275|Drug|Placebo, etanercept|Participants in triple arm (Arm 2) were given placebo etanercept injections.
12024959|NCT00405262|Drug|Ketorolac|0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
12024960|NCT00405262|Drug|Bupivacaine|0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.
12024961|NCT00405262|Drug|ketorolac + bupivacaine|"0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.
~For ketorolac, patients will receive 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter"
12024962|NCT00405249|Drug|elvucitabine|
12024963|NCT00405236|Drug|tiotropium|
12024964|NCT00405210|Drug|sorafenib (200 or 400mg bid) and taxotere iv|200 mg BID, day 3-19 cycle 1, day 2-19 other cycles 200 mg BID, day 3-21 Cycle 1, day 1-21 other cycles 400 mg BID, day 3-19 cycle 1, day 2-19 other cycles 400 mg BID, day 3-21 cycle 1, day 1-21 other cycles
12024965|NCT00405197|Behavioral|Isocaloric diet high in MUFA or Mediterranean diet|
12024966|NCT00405184|Drug|IntragamP|IntragamP - dosage based on previous dose of IntragamP prior to study entry. One cycle (Cycle 0)only administered, with dosage calculation based on body weight on Day 1 of the study and must be between 0.2-0.8 g/kg body weight. IntragamP to be administered intravenously.
12024967|NCT00405184|Drug|Ig NextGen 10%|Ig NextGen 10% - dosage based on previous dose of IntragamP in Cycle 0. Dosage calculation to use body weight on Day 1 of Cycle 1 of the study and must be between 0.2-0.8 g/kg body weight. 7 cycles administered, and patients to be dosed at 3 to 4 week intervals (in accordance with previous dosage schedule with IntragamP). Ig NextGen 10% to be administered intravenously.
12024968|NCT00405171|Drug|Nevirapine|
12024969|NCT00405158|Procedure|Acupuncture treatment|
12024970|NCT00405158|Procedure|Administration of oxytocin nasal spray|
12024971|NCT00405158|Procedure|Improved breast milk removal|
12024972|NCT00405158|Procedure|Warmth applied to breasts|
12024973|NCT00405158|Procedure|Breast massage|
12024974|NCT00405158|Drug|Anti-pyretic medication, paracetamol|
12024975|NCT00405158|Drug|cefadroxil|
12024976|NCT00405158|Drug|penicillin|
12024977|NCT00405158|Drug|flucloxacillin|
12024978|NCT00405119|Drug|AH23844 (lavoltidine)|
12024979|NCT00405119|Drug|NEXIUM (esomeprazole)|
12024980|NCT00405119|Drug|ZANTAC (ranitidine)|
12024981|NCT00405080|Drug|GW679769 (Casopitant) oral tablets|Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
12024982|NCT00405080|Drug|Rifampin oral capsules|Rifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
12024983|NCT00405067|Drug|BMS-201038 (AEGR-733)|
12024984|NCT00405067|Drug|Ezetimibe|
12024985|NCT00405054|Drug|MK0457|IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days
12024986|NCT00405041|Dietary Supplement|Dietary supplement GVG 2|2.670 g/day for 14 days
12024987|NCT00405015|Drug|rosiglitazone|Rosiglitazone 4 mg bidaily for 8 weeks
12024988|NCT00405002|Procedure|Helium dilution technique, lung CT scan|Helium dilution technique and lung CT scan
12024989|NCT00404963|Drug|placebo|
12024990|NCT00404963|Drug|GSK376501|
12024991|NCT00404937|Drug|Tobradex (Antibiotic steroid combination)|
12024992|NCT00404924|Drug|ZD6474 (vandetanib)|once daily oral tablet
12024993|NCT00404924|Other|Best Supportive Care|standard of care
12024994|NCT00404911|Behavioral|MFG therapy|MFG includes 16 weekly group therapy sessions for families with children who have ODD or CD. Sessions will include adult caregivers and all children over age 6. Each session will follow the same procedures, and will proceed through the following stages: creating social networks; information exchange; group discussions; individual family practice; and homework assignment.
12024995|NCT00404911|Behavioral|Standard of Care|Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.
12024996|NCT00404885|Drug|Placebo|PO BID
12024997|NCT00404885|Drug|LX211|0.2 mg/kg, twice a day (BID)
12024998|NCT00404885|Drug|LX211|0.4 mg/kg, twice a day (BID)
12024999|NCT00404885|Drug|LX211|0.6 mg/kg, twice a day (BID)
12025000|NCT00404846|Procedure|Hyperbaric Oxygenation Therapy|
12025001|NCT00404833|Drug|prednisolone and mycophenolate mofetil|
12025002|NCT00404833|Drug|prednisolone and chlorambucil|
12025003|NCT00404820|Drug|Zoledronic acid 5 mg solution|Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid.
12025004|NCT00404820|Drug|Alendronate 70 mg tablets|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.
12025005|NCT00404820|Drug|Calcium/Vitamin D|Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.
12025006|NCT00404807|Device|CPAP(Continuous Positive Airway Pressure)|
12025007|NCT00404794|Drug|prednisolone and mycophenolate mofetil|
12025008|NCT00404794|Drug|prednisolone and tacrolimus|
12025009|NCT00404781|Drug|cilostazol in addition to aspirin and clopidogrel|
12025010|NCT00404768|Drug|GSK221149A|6mg/h and 12 mg/h
12025011|NCT00404768|Drug|Placebo|Matched Placebo to Drug
12025012|NCT00404755|Drug|escitalopram|Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
12025013|NCT00404755|Drug|bupropion|bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
12025014|NCT00404755|Drug|imipramine|imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
12025015|NCT00404742|Drug|Placebo|PO BID
12025016|NCT00404742|Drug|LX211|0.2 mg/kg, twice a day (BID)
12025017|NCT00404742|Drug|LX211|0.4 mg/kg, twice a day (BID)
12025018|NCT00404742|Drug|LX211|0.6 mg/kg, twice a day (BID)
12025019|NCT00404729|Drug|Cytidine-5'-diphosphocholine (Citicoline)|
12025020|NCT00404716|Drug|Cilostazol|
12025021|NCT00404703|Drug|bevacizumab [Avastin]|15mg iv on day 1 of each 3 week cycle
12025022|NCT00404703|Drug|Platinum-based chemotherapy|As prescribed
12025023|NCT00404690|Procedure|Bedside Silo|silo placed at bedside on admission
12025024|NCT00404690|Procedure|Operative attempt at closure|go the operating room to attempt closure
12025025|NCT00404677|Other|deep inhalation|deep inhalation is comprised of an inhalation manoeuver from FRC to TLC
12025026|NCT00404664|Behavioral|influenza vaccine, reminders letters, raffle prize|
12025027|NCT00404651|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, intramuscular (IM)
12025028|NCT00404651|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, IM
12025029|NCT00404651|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, IM
12025030|NCT00404651|Biological|DTaP-HBV-IPV vaccine|0.5 mL, IM
12025031|NCT00404638|Drug|Desmopresin|
12025032|NCT00404638|Behavioral|Paula Method of Circular Muscle Exercise|
12025033|NCT00404625|Behavioral|Risk factors for infections due to ESBL+ Enterobacteriaceae|
12025034|NCT00404625|Behavioral|Risk factors for inadequate initial antimicrobial therapy|
12025035|NCT00404625|Behavioral|Overall and 30-day mortality in bad first antibiotic therapy|
12025036|NCT00404612|Drug|Placebo|PO BID
12025037|NCT00404612|Drug|LX211|0.2 mg/kg, twice a day (BID)
12025038|NCT00404612|Drug|LX211|0.4 mg/kg, twice a day (BID)
12025039|NCT00404612|Drug|LX211|0.6 mg/kg, twice a day (BID)
12025040|NCT00404599|Drug|atrorvastatin 10mg|Atorvastatin 10 mg once a day
12025041|NCT00404599|Drug|simvastatin 40mg|simvastatin 40mg once a day
12025042|NCT00404586|Drug|GW784568X|GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
12026116|NCT00396630|Biological|Rotarix|Two-dose oral vaccination.
12025043|NCT00404586|Drug|Fluticasone propionate|Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
12025044|NCT00404586|Drug|Placebo|Matching Placebo to GW784568X as aqueous nasal spray.
12025045|NCT00404573|Drug|RGH-188|
12025046|NCT00404547|Drug|Ciclesonide|Asthma Care with Alvesco
12025047|NCT00404547|Drug|Usual Care Inhaled Glucocorticosteroids|Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment
12025048|NCT00404534|Drug|Amoxicillin, Clarythromycin, Omeprazole for ten days|Amoxicillin 1000 mg BID, clarythromycin 500 mg BID for ten days in the experimental group and placebo of Amoxicillin 1000 mg BID and placebo of clarythromycin 500 mg BID in the placebo comparator. Both groups receive omeprazole 20 mg bid for 10 days.
12025049|NCT00404521|Drug|PM02734|Administered every 3 weeks, intravenously, over 30 minutes
12025050|NCT00404508|Drug|Hydralazine and magnesium valproate|
12025051|NCT00404495|Drug|Irinotecan|Irinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
12025052|NCT00404495|Drug|Temozolomide|Temozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles
12025053|NCT00404482|Drug|Cyclosporine A|
12025054|NCT00404469|Procedure|peritendinous corticosteroid injections|1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational
12025055|NCT00404469|Procedure|eccentric decline squat training|eccentric decline unilateral squats performed twice daily. for 12 weeks
12025056|NCT00404469|Procedure|heavy slow resistance training|Heavy slow resistance training for knee extensors. 3/week. total of 12 weeks
12025057|NCT00404456|Drug|Melatonin|Melatonin 3 mg once-daily
12025058|NCT00404443|Device|Acupuncture|Placebo-needles 17 will be used for those randomized to receive sham-acupuncture, which will be connected to the electrical current generator for the same duration and at the same acupuncture points without any current passing through, and intermittent non-specific manual twirling will also be applied. Patients are discouraged to communicate with each other before and after the treatment sessions to minimize bias.
12025059|NCT00404417|Drug|Botulinum Toxin A / Placebo|Botulinum Toxin A at first injection / Placebo at second injection
12025060|NCT00404417|Drug|Botulinum Toxin A / Botulinum Toxin A|Botulinum Toxin A at first injection / Botulinum Toxin A at second injection
12025061|NCT00404417|Drug|Placebo / Botulinum Toxin A|Placebo at first injection / Botulinum Toxin A at second injection
12025062|NCT00404417|Drug|Placebo / Placebo|Placebo at first injection / Placebo at second injection
12025063|NCT00404404|Biological|bevacizumab|
12025064|NCT00404404|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12025065|NCT00404391|Drug|Hydrocodone/Acetaminophen Extended Release|1 tablet every 12 hours
12025066|NCT00404391|Drug|Hydrocodone/Acetaminophen Extended Release|2 tablets every 12 hours
12025067|NCT00404391|Drug|Placebo|2 tablets every 12 hours
12025068|NCT00404378|Drug|ketoconazole|Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
12025069|NCT00404378|Drug|casopitant 100 mg|Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time
12025070|NCT00404378|Drug|Casopitant 50 mg|Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
12025071|NCT00404365|Other|counseling intervention|
12025072|NCT00404365|Other|screening questionnaire administration|
12025073|NCT00404365|Other|study of socioeconomic and demographic variables|
12025074|NCT00404365|Procedure|psychosocial assessment and care|
12025075|NCT00404352|Drug|RNF|Single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months, or 36 months for patients enrolled in the OL extension.
12025076|NCT00404352|Drug|RNF|Single dose of RNF administered subcutaneously once weekly at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
12025077|NCT00404352|Drug|Placebo|Placebo was supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 mL.
12025078|NCT00404339|Biological|mutant p53 peptide pulsed dendritic cell vaccine|
12025079|NCT00404339|Biological|tetanus toxoid helper peptide|
12025080|NCT00404339|Procedure|adjuvant therapy|
12025081|NCT00404326|Drug|Hydralazine and magnesium valproate|
12025082|NCT00404326|Procedure|Punch biopsy of the primary tumor|
12025083|NCT00404313|Drug|MK0633|Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633
12025084|NCT00404313|Drug|Comparator: placebo|Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks
12025085|NCT00404300|Drug|Optivate|Plasma-derived Factor VIII
12025086|NCT00404287|Drug|Fluvastatin|
12025087|NCT00404274|Drug|Casopitant (GW679769) oral tablets|Casopitant will be available in the dose strength of 20,30 or 50 mg
12025088|NCT00404274|Drug|Warfarin oral tablets|Warfarin will be available in the dose strength of 5 mg
12025089|NCT00404261|Drug|Fluticasone/Salmeterol HFA|Fluticasone/Salmeterol HFA, 2 puffs twice daily
12025090|NCT00404248|Drug|terameprocol|terameprocol will be given IV 5 consecutive days every 28 days. Starting dose 750mg/day. Cohorts of 3pts. A Dose Limiting Toxicity (DLT) target rate of Less than or equal to 33%. Dose levels: 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, 9300 mg.
12025091|NCT00404248|Other|pharmacological study|All pts on both arms will have pks, blood collections. 5ml of blood will be drawn on Cycle 1 day 1, Cycle 1 Day 5, Cycle 2 day 1 and Cycle 2 day 5. A total of 10 samples will be drawn at each of these time points. 1hr pre-infusion, 15 min, 1hr, 1.15, 1.5, 2, 3,4,6 and 24hr post infusion.
12025092|NCT00404235|Drug|carboplatin|
12025093|NCT00404235|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12025094|NCT00404222|Drug|Hydrocodone/Acetaminophen Extended-Release|2 tablets x 1
12025095|NCT00404222|Drug|Hydrocodone/Acetaminophen Immediate Release (NORCO®)|1 tablet q 4 hours x 3
12025096|NCT00404222|Drug|Placebo|q 4 hours x 3
12025097|NCT00404209|Procedure|Vitrectomy|pressurized 23GA vitrectomy with a 3D system
12025098|NCT00404196|Drug|Calcipotriol and LEO80122 (LEO19123 cream)|
12025099|NCT00404183|Drug|Extended-Release Hydrocodone/Acetaminophen|2 tablets BID
12025100|NCT00404183|Drug|Placebo|2 tablets BID
12025101|NCT00404170|Drug|B-CIT and SPECT imaging|Optional ongoing B-CIT SPECT imaging scans at follow-up visits
12025102|NCT00404157|Drug|Rituximab|
12025103|NCT00404144|Device|Drug Eluting Balloon|PCI of small vessels single arm study
12025104|NCT00404131|Drug|diquafosol tetrasodium (INS365) Ophthalmic Solution|
12025105|NCT00404105|Procedure|PRK|
12025106|NCT00404105|Procedure|LASIK|
12025107|NCT00404092|Drug|caspofungin|i.v.
12025108|NCT00404079|Drug|Glucosamine sulphate|Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
12025109|NCT00404079|Drug|Placebo|Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months
12025110|NCT00404066|Drug|Lapatinib|1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)
12025111|NCT00404066|Drug|Doxorubicin|60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.
12025112|NCT00404066|Drug|Cyclophosphamide|600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.
12025113|NCT00404066|Drug|Docetaxel|100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
12025114|NCT00404066|Drug|Pegfilgrastim|6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.
12025115|NCT00404066|Drug|Filgrastim|300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.
12025116|NCT00404066|Drug|Dexamethasone|8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel
12025117|NCT00404066|Drug|Trastuzumab|Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year
12025118|NCT00404053|Drug|Clopidogrel|
12025119|NCT00404040|Drug|Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)|
12025120|NCT00404040|Drug|Lactulose|
12025121|NCT00404014|Drug|AL-208|1 dose of 300 mg
12025122|NCT00404014|Drug|Placebo|1 dose of placebo
12025123|NCT00404001|Drug|MD-0727|
12025124|NCT00403988|Drug|Oxaliplatin|
12025125|NCT00403988|Drug|vinorelbine|
12025126|NCT00403975|Drug|diquafosol tetrasodium ophthalmic solution, 2%|
12025127|NCT00403962|Drug|vestipitant/paroxetine|
12025128|NCT00403949|Drug|Azelaic acid 15% gel|gel, applied once daily, for 6 weeks
12025129|NCT00403949|Drug|Non-active base from azelaic acid 15% gel|gel, apply once daily for six weeks
12025130|NCT00403936|Procedure|OA decompression manipulation|
12025131|NCT00403923|Dietary Supplement|Lactose in water|
12025132|NCT00403910|Drug|Canrenone|
12025133|NCT00403897|Drug|Polyethylene glycol 3350 Na bicarbonate NaCl KCl|6.9g sachet, oral
12025134|NCT00403884|Procedure|Selective RPE laser treatment|interventional SRT laser treatment
12025135|NCT00403858|Drug|Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)|
12025136|NCT00403858|Drug|Lactulose|
12025137|NCT00403845|Drug|Indacaterol 150 μg|Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
12025138|NCT00403845|Drug|Indacaterol 300 μg|Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
12025139|NCT00403845|Drug|Placebo|Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
12025140|NCT00403832|Device|intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)|
12025141|NCT00403819|Drug|Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)|
12025142|NCT00403806|Drug|dexamethasone|intravenous dexamethasone 0.05 mg per kg bodyweight
12025143|NCT00403806|Drug|Dexamethasone|Intravenous dexamethasone 0.15 mg per kg bodyweight
12025144|NCT00403806|Drug|dexamethasone|Intravenous dexamethasone 0.5 mg per kg bodyweight
12025145|NCT00403806|Drug|Saline|Intravenous saline
12025146|NCT00403793|Drug|etonogestrel with testosterone undecanoate|42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
12025147|NCT00403793|Drug|Placebo|42 or 44 weeks with placebo implant and placebo injections
12025148|NCT00403780|Drug|pregabalin|"Capsule pregabalin 75 mg once or twice daily up to a total dose of 600mg daily (300mg twice daily) for a total of minimum 14 days and maximum 8 weeks.
~Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily."
12025149|NCT00403780|Drug|placebo|Capsule placebo once or twice daily up to a total dose of 8 capsules(4 capsules twice daily) for a total of minimum 14 days and maximum 8 weeks. Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily.
12025150|NCT00403767|Drug|Rivaroxaban|Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)
12025151|NCT00403767|Drug|Warfarin|Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years
12025152|NCT00403767|Drug|Matching placebo for Rivaroxaban arm (Warfarin placebo)|Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years
12025153|NCT00403767|Drug|Matching placebo for Warfarin arm (Rivaroxaban placebo)|Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years
12025416|NCT00402051|Drug|Cisplatin|75 mg/m2, intravenous (IV), every 21 days x 6 cycles
12025154|NCT00403754|Drug|Indacaterol|In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
12025155|NCT00403754|Drug|Placebo|Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
12025156|NCT00403754|Drug|Salmeterol|Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
12025157|NCT00403741|Behavioral|motivational interviewing|
12025158|NCT00403728|Drug|ciclosporine A|
12025159|NCT00403715|Drug|diquafosol tetrasodium (INS365) Ophthalmic Solution|
12025160|NCT00403702|Drug|Oxane HD [oil-RMN3-mixture]|
12025161|NCT00403702|Drug|Densiron [(F6H8)|
12025162|NCT00403689|Dietary Supplement|Beta-D-Glucan|1,5 g Beta-D-Glucan daily
12025163|NCT00403689|Dietary Supplement|placebo|1.5 g waxy maize starch daily
12025164|NCT00403676|Other|Follow up bu a nurse|Follow up bu a nurse
12025165|NCT00403676|Other|Follow up by a medical doctor|Follow up by a medical doctor
12025166|NCT00403663|Drug|bupivacaine 0.75% with fentanyl and morphine|the following administered once, by spinal injection; 9-12 mg 0.75% hyperbaric bupivacaine 10 mcg fentanyl 100 mcg morphine
12025167|NCT00403650|Drug|Iloprost|Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day
12025168|NCT00403637|Drug|indacaterol maleate|
12025169|NCT00403624|Drug|OXALIPLATIN|
12025170|NCT00403611|Drug|Praziquantel 60 mg/kg|Praziquantel (Distocide) 60 mg/kg single oral dose
12025171|NCT00403611|Drug|Praziquantel 40 mg/kg|Praziquantel (Distocide) 40 mg/kg single oral dose
12025172|NCT00403585|Drug|adefovir dipivoxil 10mg|
12025173|NCT00403559|Drug|Elidel|
12025174|NCT00403546|Drug|Ziprasidone 80-160 mg/d|Participants will be instructed to take one study capsule of ziprasidone orally twice daily (80 mg/d). After the first week, the study drug will be increased to two capsules twice daily (160 mg/d).
12025175|NCT00403546|Drug|Placebo|Participants will be instructed to take one study capsule of matching placebo orally twice daily. After the first week, the matching placebo will be increased to two capsules twice daily.
12025176|NCT00403546|Drug|Ziprasidone 160 mg/d|Participants will be taking open-label ziprasidone 80 mg orally twice daily for a total dose of 160 mg/d from at least 3 weeks before randomization to end of study 8 weeks after randomization.
12025177|NCT00403533|Drug|20 mg of atorvastatin daily|
12025178|NCT00403520|Drug|Experimental 1|Drug: Donepezil Hydrochloride 10 mg orally for 12 months
12025179|NCT00403520|Drug|Placebo Comparator|Drug: Placebo Matching placebo orally for 12 months
12025180|NCT00403507|Behavioral|Participation in a monitored exercise program|No contact with control group during 20 weeks.
12025181|NCT00403507|Behavioral|Personalized aerobic and strength training.|Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.
12025182|NCT00403494|Drug|Placebo for 6R-BH4 (sapropterin dihydrochloride)|Placebo to be administered in the same manner as that of the investigational product for 24 weeks
12025183|NCT00403494|Drug|6R-BH4 (sapropterin dihydrochloride)|800 mg/day 6R-BH4 tablets, divided into two doses, administered orally for 24 weeks
12025184|NCT00403494|Drug|6R-BH4 (sapropterin dihydrochloride)|800 mg/day of 6R-BH4 tablets, divided into two doses, administered orally, plus 1000mg/day Vitamin C caplets, divided into two doses, administered orally for 24 weeks
12025185|NCT00403494|Drug|Placebo for 6R-BH4 (sapropterin dihydrochloride)|Placebo to be administered in the same manner as that of the investigational product, plus 1000mg/day Vitamin C, divided into two doses, for 24 weeks
12025186|NCT00403481|Drug|olmesartan medoxomil|Olmesartan medoxomil tablets, once daily
12025187|NCT00403481|Drug|Olmesartan medoxomil plus Hydrochlorothiazide|Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
12025188|NCT00403455|Drug|Paroxetine|SSRI
12025189|NCT00403442|Device|Verteporfin Therapy/ Drug: Bevacizumab|
12025190|NCT00403429|Drug|capecitabine|
12025191|NCT00403416|Drug|AEB071|
12025192|NCT00403416|Drug|Mycophenolic Acid|
12025193|NCT00403403|Drug|Bevacizumab|Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
12025194|NCT00403403|Drug|Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
12025195|NCT00403403|Drug|Placebo|Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
12025196|NCT00403390|Drug|Brand Name Levothyroxine (Synthroid)|Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.
12025197|NCT00403390|Drug|Generic formulation of Levothyroxine|Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.
12025198|NCT00403377|Behavioral|Intervention|In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
12025199|NCT00403364|Drug|Placebo amoxicillin pantoprazole clarithromycin tinidazole|
12025200|NCT00403338|Device|CYPHER® Bx Velocity™ stent (sirolimus-eluting)|
12025201|NCT00403325|Drug|rhuFab V2 [ranibizumab] ( Lucentis )|
12025202|NCT00403312|Behavioral|Smoking Cessation Behavioral Program|
12025203|NCT00403312|Drug|Nicotine Patch|
12025204|NCT00403312|Behavioral|Physical Activity|
12025205|NCT00403299|Procedure|MDCT of the coronary arteries.|
12025525|NCT00401245|Drug|desvenlafaxine succinate sustained release|Tapering 50 mg, 25 mg
12025206|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
12025207|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
12025208|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
12025209|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
12025210|NCT00403286|Drug|Fluticasone Propionate|Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
12025211|NCT00403286|Drug|Formoterol Fumarate|Inhalation Solution for nebulization 20 mcg bid for 2 weeks
12025212|NCT00403286|Drug|Fluticasone Propionate/Salmeterol Xinafoate|Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
12025213|NCT00403286|Drug|Placebo|Inhalation Solution for nebulization 2 mL bid for 2 weeks
12025214|NCT00403273|Drug|Botulinum toxin A|100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
12025215|NCT00403273|Drug|Normal Saline|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
12025216|NCT00403260|Drug|Pyronaridine artesunate|once a day for 3 days
12025217|NCT00403260|Drug|Mefloquine plus artesunate|once a day for 3 days
12025218|NCT00403247|Dietary Supplement|Capsule with folate, Vitamin B12 & pyridoxine|
12025219|NCT00403247|Other|placebo|placebo capsule
12025220|NCT00403234|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
12025221|NCT00403234|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
12025222|NCT00403234|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
12025223|NCT00403234|Drug|Placebo BTDS|Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.
12025224|NCT00403221|Genetic|RTVP-1 Gene|"Cohort Level #1 1.0 x 1010vp Cohort Level #2 5.0x1010vp Cohort Level #3 1.0 x 1011vp Cohort Level #4 5.0x1011vp Cohort Level #5 1.0 x 1012vp Cohort Level #6 5.0x1012vp
~One dose only followed by a radical prostatectomy 4 weeks later."
12025225|NCT00403208|Procedure|Analgesia based sedation in ICU patients|
12025226|NCT00403182|Drug|chemotherapy|
12025227|NCT00403182|Drug|letrozole|
12025228|NCT00403169|Drug|lenalidomide|drug
12025229|NCT00403156|Drug|Imatinib Mesylate /Ranibizumab|
12025230|NCT00403143|Procedure|cataract surgery|
12025231|NCT00403130|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
12025232|NCT00403130|Drug|Paclitaxel|Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
12025233|NCT00403130|Drug|Bevacizumab|Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
12025234|NCT00403117|Drug|Placebo + Inactive Marijuana (0% THC)|One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
12025235|NCT00403117|Drug|Placebo + Active Marijuana (3.27% THC)|One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before administration of a marijuana cigarette containing 3.27% THC (ca. 800 mg) provided by the National Institute on Drug Abuse.
12025236|NCT00403117|Drug|Naltrexone 12 Mg+ Active Marijuana (3.27% THC)|One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
12025237|NCT00403117|Drug|Naltrexone 25 Mg + Active Marijuana (3.27% THC)|One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
12025238|NCT00403117|Drug|Naltrexone 50 Mg+ Active Marijuana (3.27% THC)|One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
12025239|NCT00403117|Drug|Naltrexone 100 Mg+ Active Marijuana (3.27% THC)|One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
12025240|NCT00403117|Drug|Naltrexone 12 Mg + Inactive Marijuana (0% THC)|One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
12025241|NCT00403117|Drug|Naltrexone 25 Mg + Inactive Marijuana (0% THC)|One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
12025242|NCT00403117|Drug|Naltrexone 50 Mg + Inactive Marijuana (0% THC)|One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
12025243|NCT00403117|Drug|Naltrexone 100 Mg + Inactive Marijuana (0% THC)|One capsule containing 100mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
12025244|NCT00403104|Drug|ONO-2506PO|1200 mg QD / 18 months
12025245|NCT00403104|Drug|ONO-2506PO|0 mg QD / 18 months
12025246|NCT00403091|Behavioral|Internet Intervention|Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.
12025247|NCT00403091|Behavioral|Control|The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources.
12025248|NCT00403065|Drug|dexamethasone|
12025249|NCT00403065|Procedure|quality-of-life assessment|
12025250|NCT00403065|Radiation|radiation therapy|
12025251|NCT00403052|Drug|1018 ISS immunostimulatory oligonucleotide|6 weekly subcutaneous (under the skin) injections
12025252|NCT00403039|Drug|Ranibizumab (Lucentis )|
12025253|NCT00403026|Drug|Bevacizumab ( Avastin)|
12025254|NCT00403013|Procedure|Positioning and anesthesia|Positioning during axillary plexus block
12025255|NCT00403000|Drug|dutasteride|Oral
12025256|NCT00402987|Drug|Celecoxib|dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
12025257|NCT00402987|Drug|Celecoxib|dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
12025258|NCT00402987|Drug|celecoxib|dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
12025259|NCT00402987|Drug|placebo|dose 1 placebo followed 6-12 hours later by dose 2 placebo
12025260|NCT00402974|Drug|menaquinone 7|
12025261|NCT00402961|Other|Acupuncture|Acupuncture will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge.
12025262|NCT00402961|Other|Sham Acupuncture|Sham Acupuncture involves the acupuncturist tapping a plastic guiding tube on the surface of the true points to produce some discernible sensation and then immediately tapping a real needle sideways parallel to the skin surface without needle insertion. It will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge,
12025263|NCT00402948|Drug|TPI ASM8|0.25mg, 0.5mg for 14 days, daily dosage
12025264|NCT00402948|Drug|ASM8|inhalation 0.25mg daily for 14 days
12025265|NCT00402935|Other|laboratory biomarker analysis|Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
12025266|NCT00402935|Procedure|fertility assessment and management|Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
12025267|NCT00402935|Procedure|management of therapy complications|Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.
12025268|NCT00402935|Procedure|ultrasound imaging|Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
12025269|NCT00402909|Drug|Nateglinide|
12025270|NCT00402896|Drug|ZD6474|300 mg/day orally for 10 weeks.
12025271|NCT00402883|Drug|Bevacizumab|15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
12025272|NCT00402883|Drug|Pemetrexed|500mg/m2 week 1, 4, 16, 19 and 22.
12025273|NCT00402883|Procedure|Radiotherapy|1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
12025274|NCT00402883|Other|Folic Acid|350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.
12025275|NCT00402883|Other|vitamin B12|1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.
12025276|NCT00402883|Drug|carboplatin|AUC=5 administered intravenously weeks 1 and 4.
12025277|NCT00402870|Device|ProSeal LMA|ProSeal LMA vs Tracheal Tube
12025278|NCT00402870|Device|ProSeal LMA, Tracheal Tube|ProSeal LMA vs Tracheal Tube
12025279|NCT00402857|Behavioral|Incredible Years Program|The Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs.
12025280|NCT00402844|Device|Transvaginal mesh- PROLIFT®-system|
12025281|NCT00402831|Biological|ProQuad®|Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.
12025282|NCT00402805|Biological|Trivalent Inactivated Influenza Vaccine|
12025283|NCT00402792|Drug|Hydrocodone/Acetaminophen Extended-Release|1 tablet q 12 hours
12025284|NCT00402792|Drug|Hydrocodone/Acetaminophen Extended Release|2 tablets q 12 hours
12025285|NCT00402792|Drug|Placebo|2 tablets q 12 hours
12025286|NCT00402779|Drug|Erlotinib|150 mg by mouth daily
12025287|NCT00402779|Drug|Placebo|Tablet by mouth daily
12025288|NCT00402766|Drug|Cisplatin|Starting Dose: 60 mg/m^2 by vein, Over 2 Hours
12025289|NCT00402766|Drug|Imatinib Mesylate|Starting Dose: 300 mg PO Daily
12025290|NCT00402766|Drug|Pemetrexed|Starting Dose: 500 mg/m^2 by vein, Over 40 Minutes
12025291|NCT00402766|Drug|Dexamethasone|20 mg by vein given prior to Pemetrexed therapy and 4 mg given orally on Day 2 of each cycle.
12025292|NCT00402753|Behavioral|Ambulatory Physical Exercise Program|supervised exercise, 2 x / week
12025293|NCT00402740|Device|Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)|All subjects will receive the Xact™ Rapid Exchange Carotid Stent System. The first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3).
12025294|NCT00402727|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
12025295|NCT00402727|Drug|Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
12025296|NCT00402714|Procedure|extracorporeal photopheresis|Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
12025297|NCT00402714|Drug|Pentostatin|pentostatin 8mg/m2 over 48 hours by continuous infusion
12025298|NCT00402714|Radiation|Total Body Irradiation|600cGy TBI in 3 200cGy TBI fractions
12025299|NCT00402714|Drug|Pentostatin|pentostatin 8mg/m2 over 48 hours by continuous infusion
12025300|NCT00402714|Radiation|Total Body Irradiation|600cGy TBI in 3 200cGy TBI fractions
12025644|NCT00400335|Drug|Nanomilled testosterone|
12025301|NCT00402701|Behavioral|Walking School Bus Program|Schoolwide promotion of walk to school. Facilitation of parent-led walking school bus routes.
12025302|NCT00402688|Drug|levofloxacin|750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
12025303|NCT00402688|Drug|levofloxacin|750mg tablet once daily for 3 weeks followed by 1 week of placebo.
12025304|NCT00402688|Drug|levofloxacin|500mg tablet once daily for 4 weeks.
12025305|NCT00402675|Procedure|Timing of percutaneous coronary intervention|Immediate, early or selective invasive angiography
12025306|NCT00402662|Drug|everolimus|
12025307|NCT00402662|Drug|Imatinib|
12025308|NCT00402649|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|Inactivated influenza A/H5N1 vaccine administered via intramuscular (IM) injection; dosage 45-mcg.
12025309|NCT00402636|Device|rapamycin plus 17beta estradiolvalerat-eluting stent|rapamycin plus 17beta estradiolvalerat-eluting stent was implanted due to randomisation
12025310|NCT00402636|Device|rapamycin-eluting stent|rapamycin-eluting stent was implanted due to randomisation
12025311|NCT00402623|Dietary Supplement|quercetin|1000 mg quercetin within 24 hours
12025312|NCT00402623|Other|placebo|
12025313|NCT00402610|Drug|isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment|
12025314|NCT00402597|Drug|Rivaroxaban/Placebo|1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
12025315|NCT00402597|Drug|Placebo|1 placebo tablet twice daily for 6 months.
12025316|NCT00402597|Drug|Rivaroxaban|1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
12025317|NCT00402584|Drug|sibutramine|
12025318|NCT00402571|Drug|acetaminophen|
12025319|NCT00402558|Drug|Thymoglobulin|1.5 mg/kg By Vein Daily x 3 Days
12025320|NCT00402558|Drug|Busulfan|130 mg/m^2 By Vein Over 3 Hours x 4 Days
12025321|NCT00402558|Drug|Fludarabine|40 mg/m^2 By Vein Over 30 Minutes x 4 Days
12025322|NCT00402558|Procedure|Alloreactive NK Infusion|Alloreactive NK infusion from haploidentical donor on Day -8. The alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7.
12025323|NCT00402558|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 x 109/L for 3 consecutive days.
12025324|NCT00402558|Drug|Tacrolimus|Starting dose of 0.015 mg/kg as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present.
12025325|NCT00402558|Drug|Methotrexate|5 mg/m2 intravenously on Days 1, 3 and 6 and Day +11 post transplant.
12025326|NCT00402558|Drug|Interleukin-2|0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4 only to participants receiving fourth dose level of NK cells.
12025327|NCT00402545|Drug|Cetuximab|Given intravenously on days 1, 8 and 15 of each 21-day cycle for three cycles
12025328|NCT00402545|Drug|Docetaxel|Given intravenously on day 1 of each 21-day cycle for 3 cycles
12025329|NCT00402545|Drug|Cisplatin|Intravenously on day 1 of each 21-day cycle for 3 cycles
12025330|NCT00402545|Drug|5-Fluorouracil|Given by continuous infusion pump over a period of 96 hours(dosage wil vary depending upon when participant enrolls in trial)
12025331|NCT00402532|Drug|Everolimus|Initial dosage 2 x 0.75 mg/d
12025332|NCT00402532|Drug|Mycophenolatmofetil|Initial dosage 2 x 500 mg/d intravenous
12025333|NCT00402519|Radiation|Accelerated partial breast irradiation|APBI with PDR and HDR brachytherapy
12025334|NCT00402519|Radiation|External beam whole breast irradiation|Standard Whole breast irradiation
12025335|NCT00402506|Drug|(MC-1) Pyridoxal 5'-phosphate|
12025336|NCT00402493|Drug|ibuprofen, latanoprost, brimonidine|to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure
12025337|NCT00402493|Drug|Ibuprofen, brimonidine, latanoprost|to determine whether commonly used OTC non-steroidal anti-inflammatory agentsn(200mg ibuprofen) taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure
12025338|NCT00402493|Drug|Ibuprofen|ibuprofen 200mg
12025339|NCT00402480|Drug|Hydroxyurea|
12025340|NCT00402467|Drug|Rivaroxaban (BAY59-7939)|2.5mg bid
12025341|NCT00402467|Drug|Rivaroxaban, (BAY59-7939)|5mg bid
12025342|NCT00402467|Drug|Rivaroxaban, (BAY59-7939)|10 mg bid
12025343|NCT00402467|Drug|Rivaroxaban, (BAY59-7939)|20mg bid
12025344|NCT00402467|Drug|Enoxaparine|30mg bid
12025345|NCT00402467|Drug|Enoxaparine|30mg bid
12025346|NCT00402454|Drug|isoniazid, rifampin + isoniazid or rifampin + pyrazinamide|
12025347|NCT00402441|Drug|Risedronate (HMR4003)|
12025348|NCT00402428|Drug|albumin interferon alfa-2b|900 mcg or 1200mcg every two week for 48 weeks
12025349|NCT00402428|Drug|peginterferon alfa-2a|180 mcg once a week for 48 weeks
12025350|NCT00402428|Drug|Ribavirin|"1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects
~=,> 75kg)"
12025351|NCT00402415|Drug|Sunitinib malate|C1: 50 mg po days 1-15, 2 weeks off C2: 50 mg po x 4 weeks, 2 weeks off
12025352|NCT00402415|Drug|Rapamycin|"Dose escalation until MTD as follows:
~C1: not given C2: 4 mg weekly, 8 mg weekly, 12 mg weekly, 20 mg weekly"
12025353|NCT00402402|Procedure|Tuberculin skin test|
12025354|NCT00402402|Procedure|Quantiferon-TB Gold assay|
12025355|NCT00402389|Drug|Omega-3 Fatty Acids (EPA plus DHA)|Four capsules will be taken daily for 8 weeks.
12025356|NCT00402389|Behavioral|Supportive psychotherapy|Supportive psychotherapy will provide education to increase understanding of the condition, guidance on how to cope with depression, and methods on how to improve self-esteem.
12025357|NCT00402389|Drug|Placebo|Four capsules will be taken daily for 8 weeks.
12025358|NCT00402376|Drug|Pravastatin, Carvedilol, Perindopril|
12025359|NCT00402376|Device|Biventricular assist device (Thoratec paracorporeal assist device)|
12025360|NCT00402363|Drug|omega-3-acid ethyl esters|
12025361|NCT00402363|Drug|Placebo|
12025645|NCT00400335|Drug|commercially available dutasteride|
12025362|NCT00402350|Drug|Inhaled Placebo|Inhaled Staccato Placebo, same number of doses as active comparator in that arm
12025363|NCT00402350|Drug|Inhaled Fentanyl 25 mcg|Inhaled Staccato Fentanyl, 25 mcg x 1 dose
12025364|NCT00402350|Drug|Intravenous Fentanyl 25 mcg|Intravenous Fentanyl 25 mcg, single dose
12025365|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 2|Inhaled Staccato Fentanyl, 25 mcg x 2 doses
12025366|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 4|Inhaled Staccato Fentanyl, 25 mcg x 4 doses
12025367|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 6|Inhaled Staccato Fentanyl, 25 mcg x 6 doses
12025368|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 12|Inhaled Staccato Fentanyl, 25 mcg x 12 doses
12025369|NCT00402337|Drug|linaclotide acetate|oral, once daily.
12025370|NCT00402337|Drug|Matching placebo|oral, once daily
12025371|NCT00402324|Drug|olanzapine|15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
12025372|NCT00402324|Drug|placebo|placebo, capsules, by mouth every evening, daily, for 6 weeks.
12025373|NCT00402324|Drug|divalproex|dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
12025374|NCT00402311|Procedure|DOC-PG: integrated multidisciplinary assessment|
12025375|NCT00402311|Procedure|Usual care: assessment by GP or one of the regional services|
12025376|NCT00402298|Drug|3,4-methylenedioxymethemphetmaine (MDMA_|Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
12025377|NCT00402298|Drug|3,4-methylenedioxymethamphetamine|Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.
12025378|NCT00402285|Dietary Supplement|lycopene supplement|
12025379|NCT00402285|Dietary Supplement|fish oil supplement|
12025380|NCT00402285|Other|Placebo|placebos for lycopene and fish oil.
12025381|NCT00402272|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12025382|NCT00402259|Drug|Esomeprazole IV|
12025383|NCT00402259|Drug|Omeprazole IV|
12025384|NCT00402246|Other|Remote Management|"The Remote Management method of treating patients consists of 3 components:
~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
12025385|NCT00402246|Other|In-Office Care|Routine in-office care
12025386|NCT00402233|Drug|Pramipexole|
12025387|NCT00402233|Drug|Placebo|
12025388|NCT00402220|Drug|TMS|Active Transcranial Magnetic Stimulation
12025389|NCT00402220|Device|Sham TMS|Sham Transcranial Magnetic Stimulation
12025390|NCT00402207|Drug|extrafine HFA-beclomethasone|
12025391|NCT00402207|Drug|HFA-fluticasone|
12025392|NCT00402194|Drug|Losartan|Tablet, 100mg, once per day for 3 months
12025393|NCT00402181|Biological|Siltuximab|Siltuximab 6 mg/kg as intravenous infusion once every 2 weeks for 12 cycles and duration of each cycle is 28 days.
12025394|NCT00402181|Drug|Dexamethasone|Dexamethasone 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles after that on Day 1 to 4 up to 12 cycles and duration of each cycle is 28 days.
12025395|NCT00402168|Drug|Belatacept|IV, IV Infusion, 5 mg/kg once every 28 days for one year
12025396|NCT00402168|Drug|Cyclosporine A|Tablets, Oral, Trough of 100-250 ng/mL, 2* daily for one year
12025397|NCT00402168|Drug|Tacrolimus|Tablets, Oral, Trough of 5-10 ng/mL, 2* daily for one year
12025398|NCT00402155|Behavioral|Stress on visual discomfort|Effects of visual discomfort are measured by contrast sensitivity, ERGs, and accommodative stability.
12025399|NCT00402142|Biological|Dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
12025400|NCT00402142|Biological|non pulsed dendritic cell untreated patients|107 DC subcutaneous 3 doses every 2 weeks
12025401|NCT00402142|Biological|pulsed dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
12025402|NCT00402142|Biological|dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
12025403|NCT00402142|Biological|non pulsed dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
12025404|NCT00402129|Procedure|1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.|
12025405|NCT00402116|Drug|enzastaurin|"Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles
~Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles"
12025406|NCT00402116|Drug|temozolomide|75 milligrams per meter squared (mg/m^2), oral, daily, 6 weeks then 200 mg/m^2, oral, daily, twelve 28 day cycles
12025407|NCT00402116|Radiation|radiation therapy|1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks
12025408|NCT00402103|Drug|Aliskiren|All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
12025409|NCT00402103|Drug|Amlodipine|All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
12025410|NCT00402103|Drug|Hydrochlorothiazide|Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.
12025411|NCT00402077|Drug|pramlintide acetate|subcutaneous injection, three times a day, 120mcg
12025412|NCT00402077|Drug|sibutramine|oral tablet, once a day, 10mg
12025413|NCT00402077|Drug|phentermine|oral tablet, once a day, 37.5mg
12025414|NCT00402077|Drug|placebo|subcutaneous injection, three times a day
12025415|NCT00402051|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles
12025417|NCT00402051|Drug|Carboplatin|Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
12025418|NCT00402038|Drug|SC Methylnaltrexone|Dose 1
12025419|NCT00402038|Drug|SC Placebo|
12025420|NCT00402025|Biological|Talimogene Laherparepvec|Talimogene laherparepvec administered by direct injection into pancreatic tumors using EUS-guided FNI, up to a maximum of 4 mL per treatment.
12025421|NCT00402012|Drug|Pioglitazone|During the double-blind, 12 weeks treatment period, subjects will self-administer study medication (pioglitazone or equivalent volume of placebo) 30 mg/day each morning. The dose of pioglitazone will be increased to 45 mg/day after 4 weeks if the fasting plasma glucose is higher than 100mg/dl or the HbA1C is higher than 7%. This dose has proven tolerability, safety and efficacy for type 2 diabetes and has previously been used at the Pennington Center in studies on pioglitazone.
12025422|NCT00401986|Device|Bronchial thermopladsty with the Alair System|Treatment of airways with the Alair System in PREDECESSOR STUDY
12025423|NCT00401973|Drug|olanzapine|5-20 milligrams (mg), oral, daily for 22 weeks.
12025424|NCT00401973|Drug|amantadine|Amantadine, 100 milligrams (mg), oral, 1 twice a day (BID). Patients who gained greater than 3 kilograms (kg) will switch to metformin. Patients who gained greater than 3 kg after switching to metformin will be switched to zonisamide.
12025425|NCT00401973|Drug|metformin|Metformin, 500 mg, oral, twice a day (BID) for 2 weeks titrated to 500mg three times a day (TID) thereafter. Patients who gain greater than 3 kilograms (kg) will be switched to amantadine. Patients who gained greater than 3 kg after switching to amantadine will be switched to zonisamide.
12025426|NCT00401973|Drug|zonisamide|Zonisamide, 100-400mg, oral, daily.
12025427|NCT00401973|Behavioral|Wellness education|weight management
12025428|NCT00401960|Drug|Daptomycin|daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis
12025429|NCT00401947|Drug|ACH-0137171|
12025430|NCT00401921|Drug|Minocycline|100 mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery
12025431|NCT00401921|Drug|Placebo oral capsule|1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.
12025432|NCT00401895|Device|TIPS created with 8 or 10 mm covered stent|creation of a shunt between hepatic vein and portal vein with PTFE-covered stents
12025433|NCT00401882|Drug|Epinephrine|Epinephrine (1 mg) IV additional doses
12025434|NCT00401882|Drug|Metoprolol|Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses
12025435|NCT00401869|Drug|Epoetin alfa|
12025436|NCT00401856|Drug|Eplerenone|50mg oral route
12025437|NCT00401856|Drug|Placebo|Placebo is identical to eplerenone but the active ingredient is absent
12025438|NCT00401843|Biological|Siltuximab|Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during cycle 1 in Part 1. Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during 42-day Treatment Phase and 35-day Maintenance Phase in Part 2.
12025439|NCT00401843|Drug|Bortezomib|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus once every 2 weeks during cycle 1 in Part 1. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period during 42-day treatment phase in Part 2. Bortezomib 1.3 mg/m2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) during 35-day Maintenance Phase in Part 2.
12025440|NCT00401843|Drug|Placebo|Matching placebo will be administered as intravenous infusion once every 2 weeks during 42-day treatment phase and 35-day maintenance phase in Part 2.
12025441|NCT00401843|Drug|Dexamethasone|Dexamethasone tablet will be administered in this study at the first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles in treatment phase and maintenance phase of Part 2.
12025442|NCT00401830|Drug|Lacosamide|Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg
12025443|NCT00401830|Other|Placebo|Matching placebo tablet administered twice daily
12025444|NCT00401817|Drug|Bevacizumab|15 mg/kg on day 1 of each of 6 cycles
12025445|NCT00401817|Drug|Rituximab|"Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.
~The dose to be administered is:
~Rituximab: 375 mg/m2"
12025446|NCT00401817|Drug|CHOP|Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7
12025447|NCT00401804|Drug|Dexamethasone, Bortezomib, Doxorubicin|
12025448|NCT00401791|Behavioral|Exercise|"Interval Exercise Training: Each interval training session will start with 10 minutes of warm up and will end with 10 minutes of cool down period at 40% VO2 peak. Training duration, intensity and number of exercise bout will increase with the progression of training period
~Aerobic training: Each endurance training session will start with 5 minutes of warm up and will end with 5 minutes of cool down at 40% VO2 peak. Subjects will exercise at 70% VO2 peak for 45 minutes on day 3 and 5, for 55 minutes on day 8 and 10, and for 35 minutes on day 14 using a bicycle ergometer."
12025449|NCT00401778|Drug|RAD001|Patients will be assigned to one of three treatment arms with RAD001 doses of 5, and 10 mg/day for 21-28 days sequentially taken orally in tablet form.
12025450|NCT00401765|Drug|CNTO 328|Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.
12025451|NCT00401765|Drug|Docetaxel|Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.
12025452|NCT00401752|Drug|Esomeprazole|
12025453|NCT00401752|Drug|Ranitidine|
12025454|NCT00401739|Drug|CSL360|Weekly IV Infusion. Dose escalation study.
12025455|NCT00401726|Drug|Venlafaxine ER|
12025456|NCT00401726|Behavioral|Dialogues Time to Talk Program|
12025457|NCT00401713|Procedure|Transplantation of autologous RPE|RPE cell suspension
12025458|NCT00401713|Procedure|Translocation of autologous RPE and Choroid|RPE patch
12025459|NCT00401687|Drug|Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension|The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.
12025460|NCT00401674|Drug|carboplatin|
12025461|NCT00401674|Drug|paclitaxel|
12025462|NCT00401661|Drug|Alfuzosin|One tablet of 10mg once daily at the end of evening meal
12025463|NCT00401648|Drug|Brivaracetam|
12025464|NCT00401635|Drug|liposomal doxorubicin|
12025465|NCT00401635|Drug|carboplatin|
12025466|NCT00401622|Behavioral|OneTouch® Ultra®2 System|Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
12025467|NCT00401622|Behavioral|Standard care|Standard education and self-monitoring of blood glucose performed with traditional meter systems
12025468|NCT00401609|Drug|gemcitabine|
12025469|NCT00401609|Drug|vinorelbine|
12025470|NCT00401609|Drug|cisplatin|
12025471|NCT00401609|Drug|etoposide|
12025472|NCT00401609|Drug|carboplatin|
12025473|NCT00401596|Drug|Xolair (omalizumab)|
12025474|NCT00401583|Drug|GW786034 (pazopanib)|Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.
12025475|NCT00401583|Drug|Probe drugs|probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).
12025476|NCT00401570|Drug|Volociximab|Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
12025477|NCT00401570|Drug|Gemcitabine|Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment
12025478|NCT00401544|Drug|darbepoetin alfa|Darbepoetin alfa administered by subcutaneous injection.
12025479|NCT00401544|Drug|IV iron dextran|Administered by intravenous (IV) injection.
12025480|NCT00401531|Biological|DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines|0.5 mL, IM
12025481|NCT00401531|Biological|DTaP-HB-IPV and Pneumococcal polysaccharide vaccines|0.5 mL, IM
12025482|NCT00401518|Device|Non-randomized ACADIA® Facet Replacement System|Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
12025483|NCT00401518|Device|Randomized ACADIA® Facet Replacement System|Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
12025484|NCT00401518|Device|Randomized Instrumented posterolateral fusion (PLF)|Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
12025485|NCT00401492|Drug|gemcitabine prolonged continuous infusion|
12025486|NCT00401492|Drug|cisplatin|
12025487|NCT00401492|Drug|vinorelbine|
12025488|NCT00401479|Drug|Placebo|
12025489|NCT00401479|Drug|Solabegron (GW427353)|
12025490|NCT00401466|Device|Implantable Cardioverter Defibrillator|ICD with Biotronik Home Monitoring capability
12025491|NCT00401453|Behavioral|Diet: carbohydrate days. (Name: oatmeal.)|Dietary intervention with two days of oatmeal compared to normal diabetes adapted diet in insulin resistant subjects.
12025492|NCT00401440|Drug|Misoprostol|400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses
12025493|NCT00401440|Drug|Misoprostol|400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses
12025494|NCT00401427|Drug|trastuzumab|
12025495|NCT00401427|Drug|vinorelbine|
12025496|NCT00401414|Drug|Warfarin|2 mg tablets take as directed by study staff (based on INR)
12025497|NCT00401401|Drug|zalutumumab|Eight weekly infusions
12025498|NCT00401401|Drug|cisplatin|Infusions
12025499|NCT00401401|Procedure|Radiotherapy|Daily in the treatment period
12025500|NCT00401388|Drug|Perifosine|Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
12025501|NCT00401388|Other|Loperamide|All patients should be instructed to take loperamide at the earliest signs of diarrhea and/or abdominal cramping after beginning perifosine.
12025502|NCT00401388|Other|Allopurinol|Patients with a known history of hyperuricemia and/or gout should receive prophylactic treatment with allopurinol 300 mg po daily.
12025503|NCT00401388|Other|Antiemetics|Antiemetic prophylaxis will be administered at the treating investigator's discretion.
12025504|NCT00401375|Drug|Methylnaltrexone|Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
12025505|NCT00401375|Drug|Placebo|Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.
12025506|NCT00401362|Drug|SC Methylnaltrexone|Dose 1
12025507|NCT00401362|Drug|SC Placebo|
12025508|NCT00401362|Drug|SC Methylnaltrexone|Dose 2
12025509|NCT00401336|Device|Magnetic resonance imaging multiecho gradient-echo sequence|Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence
12025510|NCT00401323|Drug|docetaxel (XRP6976)|
12025511|NCT00401323|Drug|cisplatin|
12025512|NCT00401323|Drug|5-fluorouracil (5-FU)|
12025513|NCT00401310|Drug|Comparator: Placebo|Placebo IV infusions 1hr/daily over 7 days.
12025514|NCT00401310|Drug|Comparator: MK0724|MK0724 8 mg/kg/hr 1 hr/daily over 7 days.
12025515|NCT00401284|Drug|EVT 201|
12025516|NCT00401271|Drug|OPC-67683|
12025517|NCT00401271|Drug|Rifafour e-275|
12025518|NCT00401258|Drug|duloxetine|30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician.
12025519|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 100 mg
12025520|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 50 mg
12025521|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 25 mg, 50mg
12025522|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 25 mg
12025523|NCT00401245|Drug|Placebo|Tapering placebo
12025524|NCT00401245|Drug|desvenlafaxine succinate sustained release|Tapering 50 mg, placebo
12025526|NCT00401245|Drug|desvenlafaxine succinate sustained release|Tapering 50 mg QOD
12025527|NCT00401232|Procedure|Blood Collection|Blood Collection
12025528|NCT00401219|Drug|conjugated estrogens/progestin (MPA)|
12025529|NCT00401206|Drug|dexmedetomidine|
12025530|NCT00401193|Drug|Tranexamic acid tablets|3900 mg/Day
12025531|NCT00401193|Drug|Tranexamic acid tablets|1950 mg/Day
12025532|NCT00401193|Drug|Placebo tablets|
12025533|NCT00401180|Drug|docetaxel|administered weekly in 5 escalating doses of 25 to 35 mg/ m(2) as a one-hour bolus intravenous infusion for 3 consecutive weeks.
12025534|NCT00401180|Drug|temozolomide|administered orally daily for 3 weeks (escalating doses of 75 to 100 mg/m(2)). Cycles were repeated at 4 week intervals.
12025535|NCT00401167|Drug|memantine|Following the baseline visit, subjects will receive memantine 5 mg OD for one week, followed by 5 mg BID for one week, followed by 10 mg QAM and 5 mg QPM for one week, followed by 10 mg BID for the following 9 weeks.
12025536|NCT00401154|Other|Stationary Cycling|Use of a stationary bicycle for exercise
12025537|NCT00401141|Procedure|Blood samples|
12025538|NCT00401128|Drug|gemcitabine hydrochloride|
12025539|NCT00401128|Drug|irinotecan hydrochloride|
12025540|NCT00401115|Drug|MS-R001 (rapamycin)|Subconjunctival injection in various dosages
12025541|NCT00401115|Drug|MS-R001 (rapamycin)|Intraocular injection in various dosages
12025542|NCT00401102|Behavioral|Interpersonal Psychotherapy for Depressed Adolescents|Open clinical trial of IPT-ASI for depressed and self-injuring adolescents, 12-18 years. Goal is to assess feasibility of using IPT-A protocol for teens with co-morbid depression and self-injury. All eligible participants receive 12 weeks of individual IPT-ASI with optional monthly booster sessions. IPT-ASI is a psychosocial intervention that focuses on the importance of interpersonal relationships in relation to psychological functioning. The first phase (4 weeks) includes a review of depression and self-injury symptoms, psycho-education about depression and self-injury, and a detailed assessment of the patient's important interpersonal relationships. The middle phase (weeks 5-9) involves interpersonal skill building, including communication skills, affect identification and expression, problem solving. The final phase ( weeks 10-12) involves review of skills, generalization of skills to other relationships, termination.
12025543|NCT00401089|Drug|Panax Ginseng|The standardized extract of Panax Ginseng was formulated by Boehringer Ingelheim Pharmaton, Switzerland and fulfills the criteria of cGMP. Quality control and safety are monitored regularly by Boehringer Ingelheim Pharmaton.
12025544|NCT00401076|Drug|SA-001|0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks
12025545|NCT00401063|Device|Acupuncture|Acupuncture treatment twice a day for eight weeks
12025546|NCT00401050|Procedure|chiropractic manipulative therapy|
12025547|NCT00401050|Procedure|knee exercises|
12025548|NCT00401050|Procedure|Graston Instrument Soft Tissue Mobilization (GISTM)|
12025549|NCT00401024|Drug|imatinib mesylate|
12025550|NCT00401024|Other|pharmacological study|
12025551|NCT00401024|Procedure|conventional surgery|
12025552|NCT00401011|Drug|Perifosine|"Phase I: Patients will receive daily perifosine (doses 50 mg/m2 or 100 mg/m2) at bedtime.
~Phase II: All patients will receive daily perifosine at bedtime. Patients will be evaluated every 3 weeks."
12025553|NCT00401011|Drug|Bortezomib|Phase I: Patients will receive 1 mg/m2 or 1.3 mg/m2 on days 1, 4, 8, and 11 every 3 weeks. Phase II: Patients will receive bortezomib on days 1,4,8 and 11 every 3 weeks.
12025554|NCT00401011|Drug|Dexamethasone|Phase II: If the patient shows progressive disease after 3 weeks, dexamethasone 20 mg will be added to perifosine and bortezomib on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 18, and 19 to perifosine at bedtime and bortezomib IV on days 1, 4, 8, and 11 q 21 days.
12025555|NCT00400998|Drug|Fluticasone Propionate|"Subjects will receive the following treatment regimen over one of two dosing periods within each of the three study phases:
~- Intranasal FPANS (Fluticasone Propionate aqueous nasal spray) 200 mcg once daily for 8 to 14 days i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL (microlitres) i.e. 50 mcg fluticasone propionate."
12025556|NCT00400998|Other|Matched FPANS placebo|"Subjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases:
~Intranasal FPANS placebo once daily for 8 to 14 days (i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL."
12025557|NCT00400985|Device|Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.|SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.
12025558|NCT00400972|Device|GlideScope videolaryngoscope|
12025559|NCT00400959|Procedure|cd133+cell intracoronary administration|
12025560|NCT00400946|Drug|asparaginase|
12025561|NCT00400946|Drug|cyclophosphamide|
12025562|NCT00400946|Drug|cytarabine|
12025563|NCT00400946|Drug|dexamethasone|
12025564|NCT00400946|Drug|dexrazoxane hydrochloride|
12025565|NCT00400946|Drug|doxorubicin hydrochloride|
12025566|NCT00400946|Drug|etoposide|Given IV
12025567|NCT00400946|Drug|leucovorin calcium|
12025568|NCT00400946|Drug|mercaptopurine|Given orally
12025569|NCT00400946|Drug|methotrexate|
12025570|NCT00400946|Drug|methylprednisolone|
12025571|NCT00400946|Drug|pegaspargase|Given IV
12025572|NCT00400946|Drug|prednisolone|
12025573|NCT00400946|Drug|therapeutic hydrocortisone|
12025574|NCT00400946|Drug|vincristine sulfate|
12025575|NCT00400946|Radiation|radiation therapy|
12025576|NCT00400933|Behavioral|psycho-education|six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
12025577|NCT00400907|Other|clinical observation|
12025578|NCT00400907|Procedure|management of therapy complications|
12025579|NCT00400881|Other|automatic tube compensation|new mode of ventilation during spontaneous breathing trial. It is a mode of the same device (mechanical ventilator) where the pressure applied by the ventilator varies according to calculations o fthe mechanical properties of the respiratory system automatically performed by the ventilator.
12025646|NCT00400335|Drug|Nanomilled dutasteride|
12025647|NCT00400322|Drug|Valganciclovir (Valcyte)|
12025580|NCT00400868|Behavioral|psycho-educational Joint protection education|individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later
12025581|NCT00400855|Drug|Fluticasone propionate|Study drug
12025582|NCT00400842|Drug|SA-001|0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
12025583|NCT00400842|Drug|SA-001|0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
12025584|NCT00400842|Drug|Placebo|Placebo
12025585|NCT00400829|Drug|eribulin mesylate|Given IV
12025586|NCT00400816|Drug|temozolomide|Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off]
12025587|NCT00400803|Drug|Gemcitabine, Carboplatin, Bevacizumab|Patients will be treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
12025588|NCT00400790|Drug|propofol|Propofol used as the primary anaesthetic agent
12025589|NCT00400790|Drug|desflurane|Desflurane used as the primary anaesthetic
12025590|NCT00400777|Drug|Valsartan, hydrochlorothiazide and amlodipine|
12025591|NCT00400764|Drug|Dulanermin|Dulanermin was administered by intravenous (IV) infusion over 1 hour on days 1-5 of each 21-day cycle.
12025592|NCT00400764|Drug|Rituximab|Rituximab was administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
12025593|NCT00400751|Behavioral|FAMCON (Family Consultation)|
12025594|NCT00400738|Drug|Saquinavir, lopinavir, ritonavir|arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID
12025595|NCT00400725|Drug|Clobex Shampoo 0.05%|twice weekly
12025596|NCT00400725|Drug|clobex shampoo placebo|twice weekly
12025597|NCT00400712|Behavioral|physical rehabilitation|two weeks intensive physical rehabilitation
12025598|NCT00400699|Other|counseling intervention|
12025599|NCT00400699|Other|study of socioeconomic and demographic variables|
12025600|NCT00400699|Procedure|psychosocial assessment and care|
12025601|NCT00400686|Biological|epoetin alfa|Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
12025602|NCT00400673|Behavioral|Two-step remission induction and risk-oriented consolidation|
12025603|NCT00400660|Drug|GSK615915A|GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
12025604|NCT00400660|Drug|Placebo|Subjects will also receive placebo inhaler.
12025605|NCT00400647|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12025606|NCT00400647|Drug|Mycophenolate mofetil|
12025607|NCT00400634|Drug|CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])|CERE-120 5.4 x 10^11 vg
12025608|NCT00400634|Procedure|Sham Surgery|Bilateral partial thickness burr holes placed, no intraparenchymal injections
12025609|NCT00400621|Drug|acetaminophen|
12025610|NCT00400608|Drug|ADVAIR HFA|
12025611|NCT00400608|Drug|ADVAIR DISKUS|
12025612|NCT00400595|Drug|Mupirocin ointment|topical ointment (already in widespread clinical use)
12025613|NCT00400595|Drug|Polysporin Triple|
12025614|NCT00400582|Drug|Candesartan up to 32 mg daily|Candesartan 4 to 32 mg daily
12025615|NCT00400569|Drug|Sunitinib Malate (SU011248)|For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.
12025616|NCT00400556|Drug|ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination|
12025617|NCT00400543|Device|Continuous positive airway pressure (CPAP)|
12025618|NCT00400530|Drug|MK0217, alendronate sodium / Duration of Treatment: 1 Month|
12025619|NCT00400530|Drug|Comparator: Alendronate-Teva / Duration of Treatment: 1 Month|
12025620|NCT00400517|Biological|sargramostim|administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
12025621|NCT00400517|Drug|thalidomide|doses up to 400 mg/day
12025622|NCT00400517|Procedure|conventional surgery|SOC care surgery
12025623|NCT00400517|Procedure|neoadjuvant therapy|post radical prostatectomy
12025624|NCT00400491|Drug|Cholecalciferol (vitamin D)|Cholecalciferol capsule 20.000 IU twice per week for 6 months
12025625|NCT00400491|Drug|Placebo|Placebo capsule twice a week, identical to the cholecalciferol capsules
12025626|NCT00400478|Drug|Rituximab|Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
12025627|NCT00400465|Procedure|Normal dressing|Normal dressing
12025628|NCT00400465|Procedure|Pressure dressing|Pressure dressing
12025629|NCT00400452|Behavioral|wheelchair skills training|
12025630|NCT00400439|Drug|dalcetrapib (RO4607381)|900mg po daily for 24 weeks
12025631|NCT00400439|Drug|placebo|po daily for 24 weeks
12025632|NCT00400426|Procedure|Radiotherapy|20 Gy in 4 fx
12025633|NCT00400413|Procedure|fMRI|
12025634|NCT00400400|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|Enteric-coated mycophenolate sodium supplied as 180 mg tablets.
12025635|NCT00400400|Drug|Mycophenolate mofetil|Mycophenolate mofetil supplied as 250 mg capsules.
12025636|NCT00400400|Drug|Placebo to mycophenolate sodium|Placebo to mycophenolate sodium matching tablets.
12025637|NCT00400400|Drug|Placebo to mycophenolate mofetil|Placebo to mycophenolate mofetil matching capsules.
12025638|NCT00400387|Drug|Fragmin P Forte (dalteparin sodium)|subcutaneous injection, once daily supported by multivitamine supplement and close monitoring
12025639|NCT00400387|Dietary Supplement|Multivitamin supplement|general pregnancy support by multivitamin supplementation and close monitoring
12025640|NCT00400374|Drug|Erlotinib|Patients will be given Erlotinib (dose escalation from 50 mg, 75 mg, and 100 mg) once daily continuously for 6 months.
12025641|NCT00400374|Drug|Celecoxib|Celecoxib, 400 mg, daily for 6 months.
12025642|NCT00400361|Drug|RG1507|Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
12025643|NCT00400348|Drug|Panzem Nanocrystal Colloidal Dispersion (NCD)|Panzem NCD 1,000 mg, four times daily for 28 consecutive days
12025648|NCT00400309|Biological|REPEVAX® after REVAXIS®|Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
12025649|NCT00400309|Biological|REPEVAX® after Placebo|Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
12025650|NCT00400296|Drug|RG547|Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.
12025651|NCT00400283|Drug|NNC 55-0414|
12025652|NCT00400270|Procedure|Breathing and relaxation exercises: the Papworth Method|
12025653|NCT00400257|Behavioral|Early detection of heart failure|Early detection of heart failure
12025654|NCT00400244|Procedure|Wheelchair skills traing program|
12025655|NCT00400231|Drug|Study drugs: Metformin and fenofibrate|145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.
12025656|NCT00400231|Drug|Study Drug: Metformin|2000mg/day
12025657|NCT00400231|Drug|Study Drug: fenofibrate|145mg/day of fenofibrate
12025658|NCT00400231|Drug|Metformin and Fenofibrate placebo|placebo metformin and fenofibrate
12025659|NCT00400218|Drug|MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks|
12025660|NCT00400205|Drug|Docetaxel|Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
12025661|NCT00400205|Drug|Cisplatin|Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
12025662|NCT00400205|Drug|5-fluorouracil|5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
12025663|NCT00400179|Drug|S-1/Cisplatin|"In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day 1.
~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour IV infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin."
12025664|NCT00400179|Drug|5-FU/cisplatin|In Arm B, 5-FU 1000 mg/m2/24 hours was administered CIV on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.
12025665|NCT00400166|Behavioral|Recovery Mentor|Provided Recovery Mentor services
12025666|NCT00400153|Drug|Atrovent Respimat (20 mcg)|
12025667|NCT00400153|Drug|COMBIVENT MDI (36/206 mcg)|
12025668|NCT00400153|Drug|Combivent Respimat (20 mcg/100 mcg)|
12025669|NCT00400153|Drug|Placebo via corresponding inhaler for blinding purposes|
12025670|NCT00400140|Device|Hyperopic lens|+3 D glasses
12025671|NCT00400127|Device|Silesian suspension belt|
12025672|NCT00400114|Drug|Irinotecan|Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
12025673|NCT00400114|Drug|Cisplatin|Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
12025674|NCT00400114|Procedure|Radiation|Radiation 50 Gy (weeks 4-9)
12025675|NCT00400114|Procedure|Surgery|Esophagectomy
12025676|NCT00400114|Drug|sunitinib (Sutent)|sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.
12025677|NCT00400101|Biological|Virosome-formulated synthetic peptides (malaria vaccine)|
12025678|NCT00400088|Drug|paroxetine|Start at 20 mg po od. Increase dose to 40 mg po od at week 4 if there is less than 20 % reduction in MADRS scores.
12025679|NCT00400088|Drug|lithium|start at 600mg po hs with dose to be flexibly titrated to a serum level of between 0.6 and 1.1 mmol/l.
12025680|NCT00400075|Drug|azathioprine|
12025681|NCT00400075|Drug|cyclophosphamide|
12025682|NCT00400036|Behavioral|Cod protein NCEP-diet|
12025683|NCT00400023|Drug|S-1|"During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.
~During the S-1 Extension Phase (Part 2), S-1 30 mg/m2 will be administered orally BID for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks."
12025684|NCT00400023|Drug|FT|During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.
12025685|NCT00400010|Behavioral|Expert System Intervention|Questionnaires on motivation to change and alcohol consumption were assessed in a clinical interview. Data were entered in a Computer and a fully automatized feedback letter was generated by an expert system. The printed feedback letter was handed out to patients by study staff the following day.
12025686|NCT00399997|Behavioral|Exercise on Prescription|
12025687|NCT00399984|Behavioral|Asthma Education Program|interactive seminars regarding daily inhaled corticosteroids
12025688|NCT00399971|Procedure|Ex Vivo Immunotherapy|Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week
12025689|NCT00399971|Drug|Ex vivo immunotherapy|i.v. infusions, once a week, at least 6 to 12 months
12025690|NCT00399945|Drug|Tobramycin|
12025691|NCT00399919|Drug|Propionyl-L-Carnitine|2 grams per day for six months
12025692|NCT00399919|Drug|PLC|2 grams/day for six months
12025693|NCT00399906|Drug|BMS-582949|Tablets, Oral, Once daily, 12 weeks
12025694|NCT00399906|Drug|Placebo|Tablets, Oral, Once daily, 12 weeks
12025695|NCT00399893|Drug|Octreotide|Octreotide to be administered by subcutaneous injection three times daily
12025696|NCT00399893|Drug|Placebo|Placebo to be administered by subcutaneous injection three times daily while on study
12025697|NCT00399880|Behavioral|Health literacy intervention|Illustrated medication schedules, pill boxes, pharmacist counseling
12025698|NCT00399867|Drug|Simvastatin|
12025699|NCT00399854|Device|Dhermia® - Industra Mecânica Fina Ltda|
12025700|NCT00399841|Device|Precision for Spinal Cord Stimulation|During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.
12025701|NCT00399828|Device|TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)|
12025702|NCT00399802|Drug|ZA|Single ZA 4 mg IV infusion at the start of treatment
12026117|NCT00396630|Biological|Placebo|Two-dose oral administration.
12025703|NCT00399802|Drug|Odanacatib|Once-daily odanacatib 5 mg tablet for 4 weeks
12025704|NCT00399802|Drug|Odanacatib matching placebo|Once-daily odanacatib matching placebo for 4 weeks
12025705|NCT00399802|Drug|ZA matching placebo|Single IV infusion of ZA matching placebo given at the start of treatment
12025706|NCT00399789|Drug|Perifosine|Perifosine will be tested in 3 dose forms
12025707|NCT00399776|Radiation|Bone Density Test|Evaluating bone mineral content and bone metabolism in adolescents on antipsychotic therapy compared to healthy adolescents
12025708|NCT00399763|Drug|Atomoxetine|Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
12025709|NCT00399763|Drug|Placebo|Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
12025710|NCT00399750|Drug|oxaliplatin|
12025711|NCT00399750|Drug|fluoropyrimidine|
12025712|NCT00399750|Drug|bevacizumab|
12025713|NCT00399737|Drug|repeated intake of fermented milk followed by a single oral dose of an ACE inhibitor|
12025714|NCT00399724|Drug|Insulin glargine|
12025715|NCT00399711|Drug|repaglinide and metformin combination tablet|
12025716|NCT00399711|Drug|rosiglitazone and metformin combination tablet|
12025717|NCT00399698|Drug|Risperdal|
12025718|NCT00399685|Drug|Ortho Tri-Cyclen LO|Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
12025719|NCT00399685|Drug|Ortho Cyclen|Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
12025720|NCT00399685|Drug|Ortho Cyclen + Efavirenz|Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
12025721|NCT00399685|Drug|Ortho Cyclen|Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.
12025722|NCT00399672|Drug|Interferon injections and ribavirin|Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
12025723|NCT00399672|Drug|Interferon injections and ribavirin|Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis. Ribavirin will be dispensed biweekly. The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.
12025724|NCT00399659|Drug|Tegaserod|
12025725|NCT00399646|Device|Metricath Gemini System|
12025726|NCT00399633|Drug|sumatriptan|
12025727|NCT00399620|Procedure|Gingival crevicular fluid samples (this procedure is added to the subject usual medical follow-up).|
12025728|NCT00399607|Procedure|Rectal biopsy during colonoscopy|Biopsies of rectal tissue will be obtained during the 3 or 5 year follow-up colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
12025729|NCT00399607|Procedure|Rectal biopsy at randomization|Biopsies of rectal tissue will be obtained at the time of randomization. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
12025730|NCT00399607|Procedure|Rectal biopsy at 1 year|Biopsies of rectal tissue will be obtained at the time of the one year follow-up visit. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
12025731|NCT00399607|Procedure|Rectal biopsy prior to colonoscopy|Biopsies of rectal tissue will be obtained 7-21 days prior to the 3 or 5 year colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
12025732|NCT00399607|Procedure|Biopsies during colonoscopy|Biopsies of the rectum, sigmoid colon and ascending colon will be obtained during the 3-5 year follow-up colonoscopy. The colonoscopy involves insertion of a flexible tube through the anus, which is then advanced the full length of the colon. Biopsies (tiny pinches of tissue less than 1/16 of an inch thick) will be taken as the colonoscopy tube is being removed. In total, 12-16 biopsies will be taken from the rectum (or lower colon about 3 - 4 inches up), sigmoid colon and ascending colon.
12025733|NCT00399594|Procedure|A|LV lead placement in region of latest mechanical velocity (tissue doppler)
12025734|NCT00399594|Procedure|B|LV lead placement in standard (lateral / posterolateral) position.
12025735|NCT00399581|Procedure|High Frequency Oscillatory Ventilation-Hi|HFOV will be conducted with recruitment maneuvers and with a table of mPaw and FiO2s that include higher mPaw's.
12025736|NCT00399581|Procedure|High Frequency Oscillatory Ventilation-Lo|HFOV will be conducted without routine recruitment maneuvers and with a table of mPaw and FiO2s that include relatively low mPaw's.
12025737|NCT00399568|Drug|IV Acetaminophen|Intravenous acetaminophen 1 g/100 mL
12025738|NCT00399568|Drug|IV Placebo 100 mL solution|IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
12025739|NCT00399542|Drug|Lubiprostone|
12025740|NCT00399542|Drug|Placebo|
12025741|NCT00399529|Biological|Allogeneic GM-CSF-secreting breast cancer vaccine|the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 108 cells for each patient and each vaccination cycle) on day 0.
12025812|NCT00398970|Device|Endobronchial ultrasound miniprobe|Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.
12026203|NCT00395915|Drug|aripiprazole|
12025742|NCT00399529|Drug|Trastuzumab|Trastuzumab is a humanized monoclonal antibody specific for the extracellular domain of HER-2/neu that is now one component of the standard of care for both early and late stage HER-2/neu-overexpressing breast cancers. It exerts a pleiotropic antitumor effect by multiple mechanisms. The antibody decreases heterodimer formation with other members of the epidermal growth factor receptor (EGFR) family, thereby indirectly inhibiting signaling through the Ras/Raf/mitogen-activated protein kinases (MAPK) and Phosphatidylinositol 3-kinase(PI3K)/protein kinase B (Akt) pathways. It also inhibits tumor neovascularization, and augments apoptosis both in vitro and in vivo. Trastuzumab prevents cleavage of the extracellular domain of HER-2/neu, thus abrogating the constitutive activation of the remaining membrane-associated intracellular domain.
12025743|NCT00399529|Drug|Cyclophosphamide|The doses of Cyclophosphamide are based on previously reported clinical experience as well as our own preclinical data demonstrating augmented vaccine efficacy with CY-modulated vaccination. In particular, 300 mg/m2
12025744|NCT00399516|Device|Precision|
12025745|NCT00399503|Procedure|Spectral T Wave Alternans|
12025746|NCT00399503|Procedure|Modified Moving Average T Wave Alternans|
12025747|NCT00399503|Procedure|Baroreceptor Sensitivity|
12025748|NCT00399503|Procedure|Heart Rate Variability|
12025749|NCT00399503|Procedure|Heart Rate Turbulence|
12025750|NCT00399503|Procedure|Deceleration Capacity|
12025751|NCT00399503|Procedure|Signal Averaged ECG|
12025752|NCT00399490|Drug|RN624 (PF-04383119)|50 mcg/kg
12025753|NCT00399477|Drug|rasagiline mesylate|Azilect®
12025754|NCT00399477|Drug|Rasagiline mesylate plus Mirapex|Mirapex, Azilect®
12025755|NCT00399477|Drug|Rasagiline mesylate with Levodopa|Azilect®, Levodopa
12025756|NCT00399477|Drug|Rasagiline mesylate with Requip|Azilect®, Requip
12025757|NCT00399464|Drug|alfuzosin|
12025758|NCT00399451|Drug|Polidocanol Sclerotherapy|
12025759|NCT00399438|Drug|Placebo|Tablets, Oral, once daily, 2 weeks
12025760|NCT00399438|Drug|BMS-562086|Tablets, Oral, once daily, 2 weeks
12025761|NCT00399425|Drug|bemiparin (low molecular weight heparin)|
12025762|NCT00399412|Device|subcutaneous ICD|
12025763|NCT00399399|Drug|azathioprine|
12025764|NCT00399399|Drug|cyclophosphamide|
12025765|NCT00399386|Procedure|EP|
12025766|NCT00399386|Procedure|ICD|
12025767|NCT00399386|Procedure|Ablation|
12025768|NCT00399360|Drug|Metformin|Starting at 500 mg twice daily and increasing to 850 mg twice daily after 3 Months
12025769|NCT00399360|Drug|Placebo|500 mg twice daily increasing to 850 mg twice daily after 3 Months
12025770|NCT00399360|Behavioral|Lifestyle Modification|Lifestyle Modification
12025771|NCT00399334|Drug|antipsychotic medications|as prescribed
12025772|NCT00399308|Device|Celaderm (Frozen Cultured Epidermal Allograft)|Four biweekly applications of Celaderm plus compression therapy
12025773|NCT00399308|Device|Celaderm (Frozen Cultured Epidermal Allograft)|Four weekly applications of Celaderm plus compression therapy
12025774|NCT00399308|Device|Control (compression bandaging)|Multi-layer compression bandaging
12025775|NCT00399295|Drug|Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg.|
12025776|NCT00399282|Drug|Omega-3 and Vitamin E supplementation|
12025777|NCT00399269|Drug|Recombinant Human Erythropoietin alpha|
12025778|NCT00399256|Drug|Acetylcysteine|
12025779|NCT00399256|Drug|Zinc|
12025780|NCT00399243|Drug|Sumatriptan 4mg Statdose injection|4mg Sumatriptan Statdose injection for use as acute therapy in a cluster headache. Consistency of response in three attacks will be measured
12025781|NCT00399230|Drug|Optive|
12025782|NCT00399217|Device|Subcutaneous Implantable Defibrillator (S-ICD) system|
12025783|NCT00399217|Device|ICD|
12025784|NCT00399204|Drug|Pioglitazone vs Metformin|
12025785|NCT00399191|Drug|stable isotope of iron, dysprosium|
12025786|NCT00399178|Drug|Transdermal delivery system|
12025787|NCT00399165|Drug|Testosterone Enanthate|Oral Testosterone 400 mg orally for 28 days
12025788|NCT00399165|Drug|Testosterone Enanthate|Oral Testosterone 800 mg orally for 28 days
12025789|NCT00399165|Drug|Dutasteride|dutasteride 0.5 mg orally, once daily for 28 days
12025790|NCT00399165|Other|placebo sesame oil|placebo sesame oil
12025791|NCT00399165|Drug|Dutasteride|24.5 mg po once (Day 0)
12025792|NCT00399152|Drug|Perifosine|Perifosine Oral Dose
12025793|NCT00399152|Drug|Sunitinib Malate|Sunitinib oral dose
12025794|NCT00399126|Drug|Perifosine|Perifosine oral dose
12025795|NCT00399126|Drug|Paclitaxel|Paclitaxel IV
12025796|NCT00399113|Drug|188Re-PTI-6D2|monoclonal antibody
12025797|NCT00399100|Procedure|HBO - hyperbaric oxygen treatment|
12025798|NCT00399087|Drug|Perifosine|Perifosine oral administration
12025799|NCT00399087|Drug|Docetaxel|IV administration
12025800|NCT00399087|Drug|Prednisone|Oral administration
12025801|NCT00399074|Drug|sulfadoxine pyrimethamine|Monthly SP
12025802|NCT00399061|Drug|Systane, Optive, Restasis|Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed
12025803|NCT00399048|Drug|OROS hydromorphone HCL ; OxyContin|
12025804|NCT00399035|Drug|Cediranib|oral tablet
12025805|NCT00399035|Drug|FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)|intravenous infusion
12025806|NCT00399035|Drug|XELOX (Capecitabine and Oxaliplatin)|intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15)
12025807|NCT00399035|Drug|Cediranib Placebo|oral tablet
12025808|NCT00399022|Drug|Duloxetine|
12025809|NCT00399009|Device|AutoSuture Premium Plus CEEA/Ethicon Proximate ILS|
12025810|NCT00398996|Drug|Early versus intermediate versus late initiation of ART|Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed
12025811|NCT00398983|Drug|Decitabine|20 mg/m^2 IV over 1 hour daily for 5 days
12025813|NCT00398957|Drug|OROS® Hydromorphone HCL; OROS® Dilaudid; Dilaudid SR (slow release); Naltrexone (an opioid antagonist).|
12025814|NCT00398944|Device|Evaluation of the impact of a guideline based computerized decision support system.|
12025815|NCT00398931|Drug|MK0217, alendronate sodium / Duration of Treatment : 5 Years|
12025816|NCT00398931|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 5 Years|
12025817|NCT00398918|Drug|zonisamide|zonisamide (100 mg)one time
12025818|NCT00398918|Drug|Placebo|Placebo Comparator
12025819|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|2,5 mg twice daily (5 mg total daily dose)
12025820|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|5 mg twice daily (10 mg total daily dose)
12025821|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|10 mg twice daily (20 mg total daily dose)
12025822|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|20 mg twice daily (40 mg total daily dose)
12025823|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|30 mg twice daily (60 mg total daily dose)
12025824|NCT00398905|Drug|Enoxaparin|40 mg once daily (40 mg total daily dose)
12025825|NCT00398892|Drug|Lipoic acid|Lipoic acid capsules
12025826|NCT00398879|Drug|Perifosine|Perifosine 50 mg/d qd
12025827|NCT00398879|Drug|Capecitabine|Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks
12025828|NCT00398879|Other|Perifosine Placebo|Placebo to Perifosine 50 mg/d qd
12025829|NCT00398866|Drug|Synvisc (Hylan G-F20; hyaluronan injection)|1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
12025830|NCT00398866|Drug|Bupivicaine (local anesthesia injection)|1 ml of bupivicaine 0.5% injected once a week for 2 weeks
12025831|NCT00398866|Drug|Kenalog (triamcinolone; corticosteroid injection)|1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
12025832|NCT00398853|Dietary Supplement|chromium picolinate 1000 mcg daily vs placebo|chromium picolinate 1000 mcg daily vs placebo
12025833|NCT00398853|Other|Placebo|Placebo
12025834|NCT00398840|Drug|ARQ 171|
12025835|NCT00398827|Drug|Dexmedetomidine|
12025836|NCT00398827|Drug|Placebo|
12025837|NCT00398814|Drug|Perifosine|For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day.
12025838|NCT00398814|Drug|Sorafenib|For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day.
12025839|NCT00398788|Drug|OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine|
12025840|NCT00398775|Procedure|antibiotic discontinuation|
12025841|NCT00398749|Drug|Epoetin alfa|40,000 IU once weekly, variable treatment length
12025842|NCT00398736|Procedure|sonographic measurement of inferior caval vein diameter|
12025843|NCT00398723|Device|Narrowband UVB|Treatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema
12025844|NCT00398710|Drug|Perifosine|150 mg daily (100 mg daily in case of dose reduction)
12025845|NCT00398697|Drug|Perifosine|
12025846|NCT00398697|Drug|Gemcitabine|
12025847|NCT00398684|Drug|Single dose nevirapine to the mother and to the child|One maternal 200 mg NVP dose at the onset of labor, and one dose of infant NVP (0.6 ml/6mg) between 48-72 hours after birth. [Infants less than 2,500g received only 0.2mL/kg]
12025848|NCT00398684|Drug|Single dose nevirapine to the mother and placebo to the child|One maternal 200 mg NVP dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. [Infants less than 2,500g received only 0.2mL/kg]
12025849|NCT00398684|Drug|Single dose placebo to the mother and to the child|One maternal placebo dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. [Infants less than 2,500g received only 0.2mL/kg]
12025850|NCT00398671|Device|Application of cool cap after primary successful CPR|
12025851|NCT00398658|Drug|gentamycin and clindamycin|
12025852|NCT00398645|Drug|GW685698X 200mcg,GW685698X 200mcg and 400mcg|
12025853|NCT00398632|Drug|Duloxetine|dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
12025854|NCT00398619|Drug|INCB13739|
12025855|NCT00398606|Drug|MK0217, alendronate sodium / Duration of Treatment : 2 Years|
12025856|NCT00398606|Drug|Comparator : calcium carbonate /Duration of Treatment : 2 Years|
12025857|NCT00398593|Behavioral|Range of electronic pill dispensers with alarms|Patients will be offered 1. Counselling with education and/or 2. Electronic reminders
12025858|NCT00398580|Drug|Nanomilled testosterone|
12025859|NCT00398580|Drug|Nanomilled dutasteride|
12025860|NCT00398580|Drug|commercially available dutasteride|
12025861|NCT00398567|Drug|HKI-272|HKI-272 by mouth
12025862|NCT00398567|Drug|trastuzumab|trastuzumab 4 mg/kg IV as a loading dose followed by trastuzumab 2 mg/kg weekly thereafter
12025863|NCT00398554|Drug|cyclophosphamide|1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
12025864|NCT00398554|Drug|doxorubicin hydrochloride|25mg/m²/day, 2 hours i.v.infusion on day 21
12025865|NCT00398554|Drug|etoposide|150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
12025866|NCT00398554|Drug|prednisone|40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
12025867|NCT00398554|Drug|vinblastine sulfate|6 mg/m² i.v. bolus on day 1 and day 21
12025868|NCT00398554|Drug|vincristine sulfate|1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29
12025869|NCT00398554|Radiation|radiation therapy|involved field irradiation, single daily fractions 1,5 Gy to max. 1,8 Gy standard dose 20 Gy, max dose 30 Gy (boost irradiation if required)
12025937|NCT00398112|Other|laboratory biomarker analysis|Correlative studies
12025938|NCT00398099|Drug|MK0826, ertapenem sodium / Duration of Treatment: 14 Days|
12025870|NCT00398541|Drug|losartan potassium (+) hydrochlorothiazide|losartan potassium (+) hydrochlorothiazide combination will be titrated upwards according to the following scheme: losartan potassium 50/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 25
12025871|NCT00398528|Drug|Glatiramer acetate, (Copaxone®)|
12025872|NCT00398528|Drug|IFN-β-1a, (Avonex®)|
12025873|NCT00398515|Drug|lenalidomide|Given orally
12025874|NCT00398515|Drug|temsirolimus|Given IV
12025875|NCT00398515|Other|pharmacological study|Correlative studies
12025876|NCT00398515|Other|laboratory biomarker analysis|Correlative studies
12025877|NCT00398502|Drug|MOA-728|
12025878|NCT00398489|Biological|trastuzumab|
12025879|NCT00398489|Drug|anastrozole|
12025880|NCT00398489|Drug|cyclophosphamide|
12025881|NCT00398489|Drug|docetaxel|
12025882|NCT00398489|Drug|epirubicin hydrochloride|
12025883|NCT00398489|Drug|goserelin acetate|
12025884|NCT00398489|Drug|tamoxifen citrate|
12025885|NCT00398489|Procedure|adjuvant therapy|
12025886|NCT00398489|Procedure|conventional surgery|
12025887|NCT00398489|Procedure|neoadjuvant therapy|
12025888|NCT00398489|Radiation|radiation therapy|
12025889|NCT00398476|Drug|fluticasone propionate (FP)|200 micrograms (mcg); an aqueous suspension of microfine FP
12025890|NCT00398476|Drug|fluticasone furoate (FF)|110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
12025891|NCT00398463|Drug|Tirofiban|Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion
12025892|NCT00398463|Drug|Placebo|Saline infusion will be administered for 14-24 hours
12025893|NCT00398450|Biological|recombinant interferon alfa-2b|
12025894|NCT00398450|Drug|azacitidine|
12025895|NCT00398437|Biological|trastuzumab|
12025896|NCT00398437|Drug|chemotherapy|
12025897|NCT00398437|Procedure|magnetic resonance imaging|
12025898|NCT00398424|Drug|S-1/Cisplatin|"PK Phase (Part 1), Beginning on Day 1 of the Pharmacokinetic Phase, 30 mg/m2 S-1 will be administered orally BID for 14 days (Days 1 through 14), followed by a 1-week recovery period.
~On Day -2 and Day 14 of the Pharmacokinetic Phase, all patients will receive a single dose of 30 mg/m2 S-1 administered orally.
~Extension Phase, Patients will receive S-1 at the dose that they tolerated in the PK Phase. S-1 will be administered orally BID for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks."
12025899|NCT00398411|Drug|moxifloxacin|400 mg p.o. per day
12025900|NCT00398411|Drug|placebo|one tablet per day p.o.
12025901|NCT00398398|Drug|Capecitabine, Oxaliplatin, Cetuximab|Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.
12025902|NCT00398385|Drug|cisplatin|
12025903|NCT00398385|Drug|gemcitabine hydrochloride|
12025904|NCT00398385|Procedure|adjuvant therapy|
12025905|NCT00398385|Procedure|conventional surgery|
12025906|NCT00398385|Procedure|neoadjuvant therapy|
12025907|NCT00398372|Drug|Rituximab|
12025908|NCT00398372|Drug|Epratuzumab|
12025909|NCT00398359|Behavioral|Motivational Interviewing (physicians)|Identifying and referring children with BMI >93%.
12025910|NCT00398359|Behavioral|Behavior Modification (families)|Group meetings and individual family meetings based on behavior modification for healthy lifestyle changes.
12025911|NCT00398333|Dietary Supplement|Eicosapentaenoic acid enriched nutritional supplement|Oral intake of nutritional supplementation: a maximum of 480 mL or a minimum of 240 mL daily during the first 3 months of the study.
12025912|NCT00398320|Drug|Capecitabine|850 mg/m2 by mouth twice a day for days 1-14 oa a 21 day cycle
12025913|NCT00398320|Drug|Oxaliplatin|130 mg/m2 intravenously on day 1 of a 21 day cycle
12025914|NCT00398320|Drug|Bevacizumab|7.5mg/kg Intravenous on day 1 of a 21 day cycle
12025915|NCT00398307|Drug|S-1/Cisplatin|"S-1 administration will be determined by degree of renal impairment as follows:
~Group A (Control): 30 mg/m2 BID Group B (Mild renal dysfunction): 30 mg/m2 BID Group C (Moderate renal dysfunction): 20 mg/m2 BID Group D (Severe renal dysfunction): 20 mg/m2 QD
~Pharmacokinetic Phase (Part 1):
~On Days -2 and 14 of the Pharmacokinetic Phase, patients will receive a single dose of S-1 administered orally in the morning.
~Treatment will be followed by 1 week of recovery (Days 15 through 21).
~Extension Phase (Part 2):
~S-1 will be administered orally for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks."
12025916|NCT00398294|Drug|MK0733, simvastatin / Duration of Treatment: 12 Weeks|
12025917|NCT00398281|Drug|dutasteride|Given orally
12025918|NCT00398281|Other|placebo|Given orally
12025919|NCT00398268|Procedure|Kirschner-wire fixation|
12025920|NCT00398255|Behavioral|self-management program|
12025921|NCT00398242|Device|above or below elbow cast for the last 3 weeks of treatment|
12025922|NCT00398229|Drug|s.c. human chorionic gonadotropin (Ovitrelle)|S.C. Ovitrelle 250 mcg once
12025923|NCT00398216|Drug|DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor|
12025924|NCT00398203|Device|NaviAid™ BGE Device|NaviAid™ Balloon Guided Endoscopy Device
12025925|NCT00398190|Behavioral|Control|Standard anti-tobacco programming
12025926|NCT00398190|Behavioral|Media Literacy|Anti-smoking media literacy curriculum intervention
12025927|NCT00398151|Drug|MK0476, montelukast sodium / Duration of Treatment: 12 Weeks|
12025928|NCT00398138|Biological|WT-1 analog peptide vaccine|
12025929|NCT00398138|Biological|incomplete Freund's adjuvant|
12025930|NCT00398138|Biological|sargramostim|
12025931|NCT00398138|Genetic|polymerase chain reaction|
12025932|NCT00398138|Other|flow cytometry|
12025933|NCT00398138|Other|immunoenzyme technique|
12025934|NCT00398125|Drug|GSK364735|
12025935|NCT00398112|Drug|sunitinib malate|Given orally
12025936|NCT00398112|Other|pharmacological study|Correlative studies
12025939|NCT00398086|Drug|Gemcitabine|Administered by intravenous infusion over 30 minutes.
12025940|NCT00398086|Drug|Albumin-bound paclitaxel|Administered by intravenous infusion over 30 minutes.
12025941|NCT00398073|Biological|mouse gp100 plasmid DNA vaccine|
12025942|NCT00398073|Device|The Dermal PowderMed® devices|
12025943|NCT00398073|Other|intramuscularly (IM injection)|
12025944|NCT00398060|Behavioral|Cognitive-behavioral life-style counseling|
12025945|NCT00398047|Drug|Azacitadine and Hematopoietic Growth Factors|Combination of Azacitadine and Hematopoietic Growth Factors
12025946|NCT00398034|Drug|Testosterone Gel|
12025947|NCT00398008|Drug|Buprenorphine/Subutex|Opioid agonist medication to treat opiate dependence
12025948|NCT00398008|Drug|Naltrexone|Opioid antagonist medication to treat opiate dependence
12025949|NCT00398008|Behavioral|Drug counseling|DC-HIV: Drug Counseling that provides education about HIV, drug abuse and dependence; encourages medication adherence; uses motivational enhancement techniques; encourages life style changes; and teaches cognitive and behavioral coping skills to prevent relapse
12025950|NCT00397995|Procedure|above- or under elbow cast|
12025951|NCT00397982|Biological|Bevacizumab|Given IV
12025952|NCT00397982|Other|Laboratory Biomarker Analysis|Correlative studies
12025953|NCT00397982|Drug|Temsirolimus|Given IV
12025954|NCT00397982|Procedure|Therapeutic Conventional Surgery|Undergo tumor resection
12025955|NCT00397969|Other|counseling intervention|
12025956|NCT00397969|Procedure|screening colonoscopy|
12025957|NCT00397956|Drug|MK0826, ertapenem sodium / Duration of Treatment: 14 Days|
12025958|NCT00397943|Biological|GSK's candidate Mycobacterium tuberculosis vaccine 692342|Intramuscular injection, 2 doses at 0, 1 month
12025959|NCT00397943|Biological|Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system|Intramuscular injection, 2 doses at 0, 1 month
12025960|NCT00397943|Biological|Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline|Intramuscular injection, 2 doses at 0, 1 month
12025961|NCT00397943|Biological|Control vaccine with the adjuvant system.|Intramuscular injection, 2 doses at 0, 1 month
12025962|NCT00397930|Procedure|Standard Care Control Condition|Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
12025963|NCT00397930|Procedure|Yoga Intervention (YOCAS)|The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
12025964|NCT00397917|Drug|Folic acid: 4 mg versus 0.4 mg per day|Folic acid
12025965|NCT00397904|Biological|cetuximab|
12025966|NCT00397904|Drug|cisplatin|
12025967|NCT00397904|Drug|irinotecan hydrochloride|
12025968|NCT00397904|Other|immunohistochemistry staining method|
12025969|NCT00397904|Other|laboratory biomarker analysis|
12025970|NCT00397904|Procedure|biopsy|
12025971|NCT00397891|Drug|bapineuzumab|The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
12025972|NCT00397891|Drug|bapineuzumab|The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
12025973|NCT00397891|Drug|bapineuzumab|The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
12025974|NCT00397878|Drug|saracatinib|Given orally
12025975|NCT00397878|Other|laboratory biomarker analysis|Correlative studies
12025976|NCT00397865|Behavioral|Educational booklet|Parental perception of educational booklet and evaluating any change in child's weight.
12025977|NCT00397852|Procedure|Kirschner-wires or not|
12025978|NCT00397839|Drug|Ibandronate|Ibandronate orally (tablet) at a dose of 150 mg once per month
12025979|NCT00397839|Drug|placebo|Placebo orally (tablet) at a dose of 150 mg once per month
12025980|NCT00397826|Drug|MK0733|Duration of Treatment: 12 Weeks
12025981|NCT00397813|Drug|Cyclosporine|Given PO
12025982|NCT00397813|Drug|Fludarabine Phosphate|Given IV
12025983|NCT00397813|Other|Laboratory Biomarker Analysis|Correlative studies
12025984|NCT00397813|Drug|Mycophenolate Mofetil|Given PO
12025985|NCT00397813|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo transplantation
12025986|NCT00397813|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC transplant
12025987|NCT00397813|Radiation|Total-Body Irradiation|Undergo TBI
12025988|NCT00397800|Biological|rituximab|
12025989|NCT00397800|Drug|cyclophosphamide|
12025990|NCT00397800|Drug|fludarabine phosphate|
12025991|NCT00397800|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12025992|NCT00397787|Drug|sunitinib malate|Given PO
12025993|NCT00397774|Behavioral|Physical exercise|Physical exercise twice a week for 8 weeks, and best supportive care
12025994|NCT00397774|Other|best supportive care|
12025995|NCT00397761|Drug|capecitabine|
12025996|NCT00397761|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12025997|NCT00397761|Procedure|neoadjuvant therapy|
12026055|NCT00397189|Drug|Circadin|Prolonged release melatonin 2 mg
12026056|NCT00397189|Drug|placebo circadin|placebo circadin tablets
12026057|NCT00397176|Drug|desvenlafaxine succinate sustained release (DVS SR)|
12025998|NCT00397735|Procedure|amniocentesis|Amniotic fluid will be retrieved for routine amniocentesis to rule-out or confirm intra-amniotic infection and /or inflammation. The amniocentesis procedure will be clinically indicated and the patient will undergo the procedure independent of our study.
12025999|NCT00397735|Drug|N-acetylcysteine or placebo|Only women with amniocentesis results consistent with infection/inflammation will be randomized
12026000|NCT00397722|Drug|GW876008|
12026001|NCT00397722|Drug|paroxetine|
12026002|NCT00397709|Drug|I ( isoniazid), II (isoniazid + rifampin )|
12026003|NCT00397696|Drug|[123I] 5-IA|All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations using the MMSE, the ANAM computerized cognitive battery, and other tests of executive function. All subjects will be evaluated with United Parkinson Disease Rating Scales (UPDRS) following an overnight withdrawal of anti-parkinson medication. Subjects will be asked to undergo an injection of [123I] 5-IA followed by SPECT imaging as described below. A second [123I] 5-IA and SPECT imaging study will be obtained for reliability testing between 2 weeks and 2 months following the initial [123I] 5IA imaging session.
12026004|NCT00397683|Drug|MK0822|
12026005|NCT00397670|Drug|Drug: BufferGel® with diaphragm|
12026006|NCT00397657|Drug|extended release niacin|Extended release niacin will be started at 1000mg and titrated to 2000mg once a day
12026007|NCT00397657|Drug|ezetimibe|Ezetimibe 10mg once daily
12026008|NCT00397644|Behavioral|Prompting (survey instrument/resources list) (behavior)|
12026009|NCT00397631|Drug|sitagliptin 100 mg q.d./pioglitazone 30 mg q.d|Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.
12026010|NCT00397631|Drug|Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.|Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.
12026011|NCT00397605|Drug|Synthetic cannabinoids (1:1 ratio of THC % CBD)|Randomized crossover study of 2 weeks of active study medication (maximum daily dosage of 60 mg) vs. 2 weeks of matching placebo.
12026012|NCT00397592|Drug|Growth Hormone|
12026013|NCT00397579|Drug|DT388IL3|Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.
12026014|NCT00397566|Drug|HIV Integrase Inhibitor (BMS-707035)|
12026015|NCT00397553|Drug|Insulin glulisine|
12026016|NCT00397540|Procedure|PEIT|Percutaneous Ethanol Injection Therapy
12026017|NCT00397540|Procedure|RFTA|Radiofrequency Thermal Ablation
12026018|NCT00397527|Drug|lactoserum|
12026019|NCT00397514|Procedure|Congenital Heart Surgery Patients|undergoing either Biventricular (BiV) pacing or Right Ventricular (RV) Pacing
12026020|NCT00397501|Biological|trastuzumab|"Trastuzamab, 6mg/kg, within 48 hrs before BBBD
~Then, Trastuzumab, 2mg/kg, weekly until next BBBD Then continue for 12 cycles"
12026021|NCT00397501|Drug|carboplatin|200mg/m2/day x 2 days; total dose 400mg/m2 Infused i.a. over 10 mins in 200ml of normal saline after MTX infusion
12026022|NCT00397501|Drug|methotrexate|2500 mg/day x 2 days; total dose 5000mg Infused over 10mins in 200ml saline beginning immediately after mannitol infusion
12026023|NCT00397501|Drug|sodium thiosulfate|STS dose admin i.v. over 15mins @ 4hrs post carboplatin = 20gm/m2; STS dose admin i.v. over 15mins @ 8hrs post carboplatin = 16gm/m2
12026024|NCT00397488|Drug|sunitinib malate|
12026025|NCT00397475|Drug|Colecalciferol|
12026026|NCT00397462|Device|calf muscle pump stimulation|Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
12026027|NCT00397449|Biological|GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)|
12026028|NCT00397436|Procedure|UV Irradiation|UV irradiation
12026029|NCT00397423|Drug|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor,5ug/kg/day iH Qd*5 days,3 months interval for 4 times
12026030|NCT00397423|Drug|NS|NS 1ml iH Qd*5 days, 3 months interval for 4 times
12026031|NCT00397410|Device|Hip protectors|
12026032|NCT00397384|Drug|cetuximab|Given IV
12026033|NCT00397384|Drug|erlotinib hydrochloride|Given PO
12026034|NCT00397384|Other|laboratory biomarker analysis|Correlative studies
12026035|NCT00397358|Drug|Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution|
12026036|NCT00397345|Biological|Trovax|1ml IM injection 2-8 weeks apart.
12026037|NCT00397345|Biological|Placebo|Placebo
12026038|NCT00397345|Biological|Standard of care therapy|subcutaneous low dose IL-2, interferon-α or sunitinib
12026039|NCT00397332|Drug|Alefacept|IM Alefacept
12026040|NCT00397319|Drug|Growth Hormone|
12026041|NCT00397306|Device|Bioimpedance Analysis|
12026042|NCT00397293|Drug|AT-101|40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
12026043|NCT00397293|Drug|topotecan|40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
12026044|NCT00397267|Drug|inhalation of corticosteroids|
12026045|NCT00397254|Drug|rizatriptan|10mg ODT 27 tablets
12026046|NCT00397254|Drug|rizatriptan|10mg ODT 9 tablets
12026047|NCT00397241|Drug|Drug: dorzolamide/timolol|
12026048|NCT00397241|Drug|Drug: latanoprost/timolol|
12026049|NCT00397241|Drug|dorzolamide/timolol and latanoprost|
12026050|NCT00397241|Drug|placebo (artificial tears)|
12026051|NCT00397228|Drug|ALTROPANE®|ALTROPANE® SPECT imaging
12026052|NCT00397215|Biological|Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)|intramuscular injection
12026053|NCT00397215|Biological|Fluarix|Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.
12026054|NCT00397202|Device|Diva Cup TM|See Detailed Description.
12026058|NCT00397163|Procedure|Remote ischemic preconditioning|Blood pressure cuff inflation
12026059|NCT00397163|Procedure|Placebo|Deflated cuff on upper arm and thigh for 20 min
12026060|NCT00397150|Behavioral|Peer-support for exclusive breastfeeding|Counselling to support exclusive breastfeeding up to the age of 6 months of age by the use of peer-counsellors in the local community
12026061|NCT00397137|Procedure|Circular stapled anopexy|Patients receiving stapled anopexy to treat haemorrhoids
12026062|NCT00397137|Procedure|Closed diathermy haemorrhoidectomy|Conventional haemorrhoidectomy as described by Ferguson method
12026063|NCT00397124|Device|PET/CT imaging|
12026064|NCT00397098|Drug|SR58611A|
12026065|NCT00397072|Drug|ZK 219477|
12026066|NCT00397059|Drug|Escitalopram|
12026067|NCT00397046|Drug|neratinib|HKI-272
12026068|NCT00397033|Drug|Paliperidone ER|6mg/day paliperidone er for 6 weeks
12026069|NCT00397033|Drug|Paliperidone ER|12mg/day paliperidone er for 6 weeks
12026070|NCT00397033|Drug|Placebo|Placebo for 6 weeks
12026071|NCT00397020|Drug|divalproex ER|Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml
12026072|NCT00397020|Drug|quetiapine|Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.
12026073|NCT00397007|Behavioral|Biofeedback-based cognitive-behavioural intervention|
12026074|NCT00396994|Device|Low magnitude mechanical stimulation|10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz
12026075|NCT00396994|Device|Sham low magnitude mechanical stimulation|10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform
12026076|NCT00396981|Device|Matrix 2® coils for endovascular aneurysm occlusion|endovascular aneurysm occlusion coil
12026077|NCT00396981|Device|GDC® coils for endovascular aneurysm occlusion|endovascular aneurysm occlusion coil
12026078|NCT00396968|Drug|AMD3100|
12026079|NCT00396968|Procedure|Allogeneic Stem Cell Transplantation|
12026080|NCT00396955|Drug|PLA-695|
12026081|NCT00396929|Drug|local intracoronary dosis of Paclitaxel|
12026082|NCT00396916|Device|PET/CT imaging|
12026083|NCT00396903|Device|catheter|
12026084|NCT00396877|Drug|Clopidogrel (SR25990)|"Form: reconstituted solution using Clopidogrel powder
~Route: oral or enteric
~Frequency: once daily
~Dose: daily dose adjusted for weight"
12026085|NCT00396877|Drug|placebo|"Form: reconstituted solution using matching placebo powder
~Route: oral or enteric
~Frequency: once daily
~Dose: daily dose adjusted for weight"
12026086|NCT00396864|Drug|NPI-0052|NPI-0052 IV injection at doses ranging from 0.0125 to 0.8 mg/m2 over 1 to 10 minutes on Day 1, Day 8, Day 15 of each 28-day Cycle; 11 dose cohorts during dose-escalation
12026087|NCT00396851|Drug|Gurmar|
12026088|NCT00396851|Drug|Metformin|
12026089|NCT00396825|Behavioral|Video-based coping skills training with telephone coaching|Subjects will view the 10 modules of Williams LifeSkills Caregiver Video, do Workbook exercises for each module, and receive telephone coaching to enhance their ability to apply the skills taught in each module to caregiver situations.
12026090|NCT00396812|Drug|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
12026091|NCT00396799|Drug|bazedoxifene/conjugated estrogens|
12026092|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe
12026093|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe
12026094|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe
12026095|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe
12026096|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe
12026097|NCT00396786|Drug|Enoxaparin|Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets
12026098|NCT00396760|Drug|aprotinin or tranexamic acid|
12026099|NCT00396747|Drug|Infliximab, methylprednisolone, methotrexate|
12026100|NCT00396747|Drug|Methotrexate|
12026101|NCT00396747|Drug|Methotrexate + Methylprednisolone|
12026102|NCT00396747|Drug|Methotrexate + Infliximab|
12026103|NCT00396734|Drug|Provigil (Modafinil)|Increase from 100mg to 400mg during 1 month of treatment
12026104|NCT00396734|Drug|Topamax (Topiramate)|Increase from 25mg to 200mg in one month (double every week)
12026105|NCT00396721|Drug|ACE inhibitor + statin|sirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d
12026106|NCT00396721|Drug|Sirolimus (study drug)+ACE inhibitor + statin|enalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d
12026107|NCT00396708|Device|myomo e100 neurorobotic elbow brace|
12026108|NCT00396695|Procedure|Blood test|
12026109|NCT00396682|Drug|Cyclophosphamide|150 - 250 - 350 mg
12026110|NCT00396669|Drug|Bupropion|We measure dopamine release at the striatum using 11 C Raclopride at baseline and after smoking a cigarette
12026111|NCT00396669|Drug|Bupropion|Brain imaging after treatment with Bupropion
12026112|NCT00396656|Drug|Atenolol|100 mg tablets orally once a day (od) in the morning.
12026113|NCT00396656|Drug|Hydrochlorothiazide (HCTZ))|12.5 or 25 mg tablets orally once a day (od) in the morning.
12026114|NCT00396656|Drug|Valsartan|80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
12026115|NCT00396643|Drug|Omega 3 fatty acids|The active treatment is a supplement of yellow gelatin 0.5 g fish oil capsules. The daily dose of 4 (2x2) capsules provides 700 mg of eicosapentaenoic acid and 500 mg of docosahexaenoic acid, and 10 mg of Vitamin E. Placebo treatment comprises coconut oil capsules, carefully matched with the active treatment with respect to both appearance and flavor, also containing 10 mg Vitamin E, and 10 mg of fish oil to mimic taste. Coconut oil was chosen as placebo because it does not contain polyunsaturated fatty acids and has no impact on n-3 fatty acid metabolism. The intervention period is 12 weeks.
12026118|NCT00396617|Device|prothesis voice|The device may be used for patient using another type of voice prosthesis, of for patient undergoing total laryngectomy. This device is definitively placed in two parts:The first one is introduced in the puncture (TEP) through the esophagus (retrograde way). The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
12026119|NCT00396617|Procedure|total laryngectomy|The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
12026120|NCT00396604|Drug|indacaterol maleate|
12026121|NCT00396591|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4.0 mg/kg administered intravenously (IV) once every 2 weeks
12026122|NCT00396578|Drug|aerosolized vancomycin or gentamicin|
12026123|NCT00396565|Drug|ER OROS paliperidone|Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
12026124|NCT00396565|Drug|Placebo|Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
12026125|NCT00396565|Drug|Olanzapine|Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.
12026126|NCT00396552|Device|refractory transcranial magnetic stimulation (rTMS)|Bilateral rTMS will be delivered according to the following protocol: high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the RMT for a total of 25 minutes of stimulation. Following this HFR stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered.
12026127|NCT00396552|Device|Sham condition|Sham stimulation will be made at the site of active treatment but with only the side edge resting on the scalp. It will be administered as HFL and HFR for 50 minutes but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those with active stimulation but with minimal direct brain effects. Participants will be unable to see the stimulating coil and therefore will remain blind to the treatment condition.
12026128|NCT00396526|Drug|Oral Co-trimoxazole (8mg/kg/day trimithoprim) twice a day for five days vs. oral amoxycillin (20 mg/kg/day) thrice a day for three days.|
12026129|NCT00396513|Drug|Simvastatin|
12026130|NCT00396513|Drug|Simvastatin and Metformin|
12026131|NCT00396513|Drug|Metformin|
12026132|NCT00396500|Drug|Albendazole (400 mg) and/or Vitamin a|
12026133|NCT00396487|Drug|Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat|
12026134|NCT00396474|Other|post GH treatment observational study|Intravenous glucose tolerance test (IVGTT)
12026135|NCT00396461|Drug|MCT/LCT (1:1)|Emulsion based on 20% MCT/LCT (50:50 ratio)
12026136|NCT00396461|Drug|MCT/LCT/omega-3 (5:4:1)|Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides.
12026137|NCT00396448|Drug|CP-945,598 Treatment B|Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
12026138|NCT00396448|Drug|CP-945,598 Treatment A|Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
12026139|NCT00396448|Drug|Placebo|Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
12026140|NCT00396435|Drug|Neorecormon|Administration SC one a week in patients randomized in group A Administration SC if Hb below 10.5 g/dl in group B
12026141|NCT00396422|Drug|RWJ-445380|
12026142|NCT00396409|Drug|Depigoid|Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)
12026143|NCT00396409|Drug|Omalizumab|anti-IgE (Omalizumab) given during the 2006 core study
12026144|NCT00396409|Drug|Placebo|Placebo given during the 2006 core study
12026145|NCT00396396|Drug|Acetylcysteine|
12026146|NCT00396383|Drug|plerixafor|Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4*10^6 CD34+ cells/kg body weight had been collected.
12026147|NCT00396370|Biological|BCG strain Connaught|Connaught strain Bacillus Calmette-Guerin (BCG), 8-32 x 10^5 CFU vaccine for intradermal administration.
12026148|NCT00396370|Biological|BCG strain Danish|Bacillus Calmette-Guerin (BCG) strain Danish from the Statens Serum Institute (SSI BCG). 1.2 X 10^8 colony-forming units (CFU) oral (PO) in 60 mililiters phosphate buffered saline (PBS).
12026149|NCT00396370|Biological|BCG strain Danish|Bacillus Calmette-Guerin (BCG) strain Danish from the Statens Serum Institute (SSI BCG). 2-8 X 10^5 colony-forming units (CFU) intradermal in 100 microliters diluent.
12026150|NCT00396370|Other|Placebo|0.1 mL of sterile Sauton medium for intradermal administration.
12026151|NCT00396370|Other|Placebo|60 mL of sterile phosphate buffered saline (PBS) for oral administration.
12026152|NCT00396357|Drug|Vildagliptin|
12026153|NCT00396357|Drug|metformin|
12026154|NCT00396344|Other|Çontrol|Intravenous saline
12026155|NCT00396344|Drug|Hydrocortisone|Intravenous stress dose of hydrocortisone
12026156|NCT00396344|Drug|Hydrocortisone|Intravenous pharmacologic hydrocortisone
12026157|NCT00396331|Drug|G-CSF plus plerixafor|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
12026158|NCT00396318|Drug|tenecteplase|"2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
~Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg)."
12026159|NCT00396305|Drug|Placebo|Sterile phosphate buffered saline solution.
12026160|NCT00396305|Biological|Trivalent Inactivated Influenza|The trivalent influenza vaccine is a sterile suspension prepared from the allantoic fluids of chicken embryos infected with a specific type of influenza virus. Each 0.5 mL dose of the vaccine contains 15 mcg hemagglutinin (HA) of 3 strains of virus (H1N1, H3N2, and B). The vaccine is a liquid preparation; as such, no diluent is required. It is essentially clear and slightly opalescent in color.
12026161|NCT00396292|Drug|Oral iron tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
12026162|NCT00396292|Drug|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
12026163|NCT00396279|Biological|Denosumab|Administered by subcutaneous injection
12026164|NCT00396279|Dietary Supplement|Calcium/Vitamin D|
12026165|NCT00396266|Drug|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
12026166|NCT00396253|Drug|Tenecteplase|2 mL (2 mg) of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter.
12026167|NCT00396240|Drug|Rosuvastatin|
12026168|NCT00396240|Procedure|Initiatives to improve compliance|
12026169|NCT00396227|Drug|vildagliptin|vildagliptin as add-on to metformin
12026170|NCT00396227|Drug|thiazolidinedione (TZD)|TZD add-on to metformin
12026171|NCT00396214|Drug|Bifeprunox|52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
12026172|NCT00396214|Drug|Quetiapine|Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
12026173|NCT00396214|Drug|Bifeprunox|52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
12026174|NCT00396201|Drug|G-CSF Plus Plerixafor|Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
12026175|NCT00396175|Drug|MK0906, finasteride / Duration of Treatment : 48 Weeks|
12026176|NCT00396175|Drug|Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks|
12026177|NCT00396162|Drug|probiotic containing L.rhamnosus R0011 strain|500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks
12026178|NCT00396162|Other|Placebo|Placebo pill
12026179|NCT00396149|Biological|Placebo|Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
12026180|NCT00396149|Biological|rBet v 1|Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.
12026181|NCT00396136|Device|Corox OTW Steroid Left Ventricular Lead|This is a registry: no study required interventions necessary.
12026182|NCT00396097|Drug|Genotropin|Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
12026183|NCT00396097|Drug|Genotropin|Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
12026184|NCT00396084|Drug|Gatifloxacin|Gatifloxacin 400 mg/day x 7 days.
12026185|NCT00396084|Drug|Isoniazid|Isoniazid 300 mg/day x 7 days.
12026186|NCT00396084|Drug|Levofloxacin|Levofloxacin 1000 mg/day x 7 days.
12026187|NCT00396084|Drug|Linezolid|Linezolid 600 mg/day x 7 days; Linezolid 600 mg every 12 hours x 7 days.
12026188|NCT00396084|Drug|Moxifloxacin|Moxifloxacin 400 mg/day x 7 days.
12026189|NCT00396071|Drug|vildagliptin|vildagliptin 100 mg
12026190|NCT00396071|Drug|Placebo|matching placebo
12026191|NCT00396058|Drug|Methylphenidate|
12026192|NCT00396045|Drug|Revlimid (CC-5013)|
12026193|NCT00396032|Drug|placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
12026194|NCT00396032|Drug|tenecteplase|For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
12026195|NCT00396019|Drug|PEG-Intron|
12026196|NCT00396006|Biological|Alpha1-Proteinase Inhibitor|60 mg/kg, weekly, intravenous infusion
12026197|NCT00395993|Drug|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
12026198|NCT00395993|Drug|Ferrous Sulfate tablets|325 mg tablets TID on Days 0 through Day 42
12026199|NCT00395980|Device|surgical table pressure mat|
12026200|NCT00395967|Drug|G-CSF plus plerixafor|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
12026201|NCT00395941|Drug|Pioglitazone|
12026202|NCT00395941|Drug|Acitretin|Acitretin
12026204|NCT00395902|Drug|Sensipar after Post Transplant|
12026205|NCT00395889|Procedure|Rehabilitation including structured exercise training|Rehabilitation of at least 8 weeks, for at least twice/week. This group will also receive the exercise counseling as a part of the rehabilitation program.
12026206|NCT00395889|Procedure|Physical Activity Counseling|Six exercise counseling sessions will be carried out during a 6-month period. This group will only receive the counseling and no formal structured exercise training sessions.
12026207|NCT00395876|Drug|placebo|2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing < 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).
12026208|NCT00395876|Drug|tenecteplase|2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).
12026209|NCT00395863|Drug|Multihance|0.5 M at a single injection
12026210|NCT00395863|Drug|Arm 2 - Magnevist|0.5 M Magnevist at a single dose injection
12026211|NCT00395850|Drug|Disulfiram|Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks
12026212|NCT00395837|Behavioral|Aerobic exercise|
12026213|NCT00395824|Procedure|anticoagulation procedure|
12026214|NCT00395811|Procedure|Bone Marrow Stem Cell Therapy combined CABG|Bone Marrow Stem Cell inject into myocardium
12026215|NCT00395798|Device|Soft or stiff cervical collar(device), neck school(behavior)|
12026216|NCT00395785|Device|Carotid Stent Implantation|
12026217|NCT00395785|Device|Embolic Protection|
12026218|NCT00395772|Drug|Xarelto (Rivaroxaban, BAY59-7939)|BAY59-7939 20 mg once daily (od) for 12 weeks
12026219|NCT00395772|Drug|Xarelto (Rivaroxaban, BAY59-7939)|BAY59-7939 30 mg od for 12 weeks
12026220|NCT00395772|Drug|Xarelto (Rivaroxaban, BAY59-7939)|BAY59-7939 40 mg od for 12 weeks
12026221|NCT00395772|Drug|(LMW) Heparin + Vitamin K Antagonist|Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks
12026222|NCT00395759|Drug|Optiva artificial tear by Allergan|
12026223|NCT00395746|Drug|sulfonylurea|SU agent
12026224|NCT00395746|Drug|liraglutide|Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
12026225|NCT00395746|Drug|liraglutide|Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.
12026226|NCT00395733|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
12026227|NCT00395733|Drug|Gadopentate dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
12026228|NCT00395720|Biological|MVA85A (TB vaccine)|Intradermal vaccine
12026229|NCT00395720|Biological|MVA 85A|Intradermal vaccine
12026230|NCT00395707|Drug|Lucentis|0.3mg/0.05 ml or 0.5mg/0.05 ml
12026231|NCT00395707|Drug|Ranibizumab|0.3mg/0.05 ml or 0.5mg/0.05 ml
12026232|NCT00395707|Drug|Ranibizumab (Lucentis)|0.3mg/0.05 ml intravitreally
12026233|NCT00395707|Drug|Ranibizumab (Lucentis)|0.5mg/0.05 ml
12026234|NCT00395694|Drug|lamictal|anti-epileptic drug
12026235|NCT00395681|Drug|Diprivan|Propofol 200 mg versus 350 mg
12026236|NCT00395668|Device|TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz).|
12026237|NCT00395655|Drug|Hydralazine and magnesium valproate administration|
12026238|NCT00395655|Procedure|Core-needle biopsy of the breast|
12026239|NCT00395642|Device|Kronos LV-T, Lumax HF-T|Implanted CRT-device sends out device diagnostics (e.g. heart rate, device and lead integrity, patient activity) via CardioMessenger on daily basis. In addition, daily weight and blood pressure readings are taken; remote data are analyzed by investigational sites via the internet on a weekly basis.
12026240|NCT00395629|Drug|Deferasirox (ICL670)|
12026241|NCT00395616|Drug|Botox (drug)|
12026242|NCT00395603|Drug|MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks|
12026243|NCT00395603|Drug|Comparator: atorvastatin / Duration of Treatment: 6 Weeks|
12026244|NCT00395577|Drug|VX-702|
12026245|NCT00395551|Drug|ranibizumab|0.5mg intravitreal injection
12026246|NCT00395538|Drug|PTH 1-34|Given twice daily by subcutaneous
12026247|NCT00395512|Drug|Alogliptin|Alogliptin tablets.
12026248|NCT00395512|Drug|Pioglitazone|Pioglitazone tablets.
12026249|NCT00395512|Drug|Placebo|Matching placebo tablets.
12026250|NCT00395499|Drug|Risperidone|
12026251|NCT00395486|Drug|Rosuvastatin|10mg
12026252|NCT00395486|Drug|Atorvastatin|10mg
12026253|NCT00395473|Drug|MK0653, ezetimibe / Duration of Treatment: 6 Weeks|
12026254|NCT00395460|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)
12026255|NCT00395460|Drug|Magnevist|0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)
12026256|NCT00395447|Procedure|Straight-forward Device Replacement|
12026257|NCT00395447|Procedure|Device Replacement with Upgrade|
12026258|NCT00395434|Drug|Combretastatin A4 Phosphate (CA4P)|
12026259|NCT00395434|Drug|Bevacizumab (Avastin)|
12026260|NCT00395421|Drug|NM283 plus Peg-IFNα-2a|200 mg QD 180 µg QW
12026261|NCT00395408|Drug|MK0476, montelukast sodium / Duration of Treatment : 56 Weeks|
12026262|NCT00395408|Drug|Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks|
12026263|NCT00395395|Drug|Oral salmon calcitonin, salmon calcitonin nasal spray|
12026264|NCT00395382|Drug|Alendronate|70mg weekly orally
12026265|NCT00395382|Drug|Placebo|weekly orally
12026266|NCT00395369|Drug|intraoperative aprotinin administration|
12026267|NCT00395356|Behavioral|calorie controlled diet|
12026268|NCT00395343|Drug|sitagliptin phosphate|sitagliptin 100 mg tablet qd for a 24-wk treatment period.
12026269|NCT00395343|Drug|Comparator : placebo (unspecified)|sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.
12026270|NCT00395317|Other|Placebo|placebo tablet
12026271|NCT00395317|Drug|Firategrast 150 mg|150 mg tablet
12026272|NCT00395317|Drug|Firategrast 300 mg|300 mg tablet
12026273|NCT00395304|Drug|fluticasone propionate + montelukast|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
12026274|NCT00395304|Drug|fluticasone propionate|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
12026275|NCT00395304|Drug|fluticasone propionate + salmeterol|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
12026276|NCT00395291|Drug|MK-0677|The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days.
12026277|NCT00395291|Drug|Placebo|Placebo
12026278|NCT00395252|Drug|Cetuximab (Erbitux®) and Gemcitabine|"Cetuximab:
~Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly for up to 6 months (treatment duration: 24 weeks)
~Gemcitabine:
~1000 mg/m2 administered on days 1, 8, 15 Cycles will be repeated on day 29, up to 6 treatment cycles will be administered
~Mode of administration:
~Intravenous infusion"
12026279|NCT00395239|Drug|inhaled corticosteroid|Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.
12026280|NCT00395226|Drug|zinc sulfate|zinc sulfate 220 mg bis for 90 days
12026281|NCT00395226|Drug|placebo|placebo bid for 90 days
12026282|NCT00395213|Drug|Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications|Treatment with SSRIs or SNRIs
12026283|NCT00395200|Procedure|MSC Treatment|Intravenous administration of up to 2x10^6 autologous MSCs per kg
12026284|NCT00395187|Procedure|Photodynamic Therapy|
12026285|NCT00395174|Biological|Influenza Vaccination|0.5mL dose for intramuscular injection
12026286|NCT00395161|Drug|Metoclopramide|0.2 mg/kg/dose IV every 12 hours
12026287|NCT00395161|Drug|Zinc|one enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants < or equal to one year of age, and 20 mg/day elemental zinc for patients > 1 year of age)
12026288|NCT00395161|Dietary Supplement|Glutamine|one enteral dose daily of glutamine 0.3 gm/kg/day
12026289|NCT00395161|Drug|Selenium|one enteral dose daily of selenium (40 μg for infants < 8 months of age, 60 μg for infants 8 to 12 months of age, 90 μg for children 1-3 years, 150 μg for children 4-8 years, 280 μg for children 9 to 13 years, and 400 μg for children > 13 years)
12026290|NCT00395161|Other|saline|equivalent volume of intravenous saline
12026291|NCT00395161|Other|sterile water|equivalent volume of sterile water
12026292|NCT00395161|Other|selenium|equivalent volume of sterile water
12026293|NCT00395161|Dietary Supplement|whey-protein|one enteral dose daily of whey-protein
12026294|NCT00395148|Drug|rHDL|
12026295|NCT00395135|Drug|Lorcaserin 10 mg BID|Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
12026296|NCT00395135|Drug|Matching Placebo BID|Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
12026297|NCT00395122|Device|Retinal nerve fiber layer and macular thickness measurements|
12026298|NCT00395109|Device|PET/CT|All study participates will be scanned with PET/CT scan before surgery.
12026299|NCT00395083|Behavioral|COPD Self-management Education|The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
12026300|NCT00395070|Biological|Allovectin-7®|Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
12026301|NCT00395070|Drug|Dacarbazine (DTIC)|1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
12026302|NCT00395070|Drug|Temozolomide (TMZ)|150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
12026303|NCT00395057|Drug|AGN 211745|AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
12026304|NCT00395057|Drug|AGN 211745|AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
12026305|NCT00395057|Drug|AGN 211745|AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
12026306|NCT00395057|Drug|Ranibizumab 500µg|Ranibizumab 500µg injections at Day 1, Month 1, Month 2
12026307|NCT00395044|Drug|Placebo|Placebo
12026308|NCT00395044|Drug|Gabapentin|
12026309|NCT00395031|Drug|Ziprasidone|Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
12026310|NCT00395018|Drug|entecavir|Tablets, Oral, 1 mg, once daily, up to 72 weeks
12026311|NCT00394992|Drug|oxaliplatin+capecitabine|postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w
12026312|NCT00394992|Drug|Oxaliplatin+capecitabine+bevacizumab|postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus bevacizumab 7.5 mg/kg on day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w
12026313|NCT00394966|Drug|SCH 619734 Dose 1|SCH 619734 10 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
12026314|NCT00394966|Drug|SCH 619734 Dose 2|SCH 619734 25 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
12026315|NCT00394966|Drug|SCH 619734 Dose 3|SCH 619734 100 mg (2 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
12026316|NCT00394966|Drug|SCH 619734 Dose 4|SCH 619734 200 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
12026317|NCT00394966|Drug|Placebo|Matching placebo x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
12026318|NCT00394953|Drug|Darbepoetin alfa|As prescribed, iv.
12026319|NCT00394953|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms iv / month, starting dose
12026320|NCT00394914|Drug|Pleconaril|Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.
12026321|NCT00394914|Drug|Placebo to Pleconaril|Placebo nasal suspension
12026322|NCT00394901|Drug|Placebo|placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
12026323|NCT00394901|Drug|Pregabalin|Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
12026324|NCT00394901|Drug|Pregabalin|Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
12026325|NCT00394901|Drug|Pregabalin|Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
12026326|NCT00394888|Device|MRI|MRI of the spine.
12026327|NCT00394888|Device|MRI of head and neck|MRI of head and C-spine
12026328|NCT00394888|Other|Dermatological Examination|Complete dermatological examination to identify and characterize nature of dermatological anomalies
12026329|NCT00394888|Other|Cardiac examination|Complete cardiac examination
12026330|NCT00394888|Device|Abdominal ultrasound|Abdominal ultrasound to detect hepatic hemangiomas
12026331|NCT00394875|Procedure|Treated and educated by nurses specialized in diabetes.|
12026332|NCT00394862|Drug|multivitamin|
12026333|NCT00394849|Procedure|suture one tonsillar fossa|one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
12026334|NCT00394836|Drug|Ofatumumab|Eight weekly infusions of ofatumumab. The first infusion of 300mg ofatumunab
12026335|NCT00394836|Drug|Ofatumumab|followed by 7 weekly infusions of 1000mg ofatumumab
12026336|NCT00394823|Behavioral|Set of supportive tools/measures vs. standard care|
12026337|NCT00394810|Drug|Panzem® NCD|suspension, 100 mg/mL, four times daily continuous dosing
12026338|NCT00394797|Procedure|mitral valve annuloplasty|
12026339|NCT00394771|Drug|DR-1031|Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
12026340|NCT00394771|Drug|Seasonale®|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
12026341|NCT00394771|Drug|Portia®|Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
12026342|NCT00394758|Procedure|CO2 laser surgery|
12026343|NCT00394758|Procedure|ultrasonic surgical aspiration|
12026344|NCT00394745|Drug|Valsartan|
12026345|NCT00394732|Device|Total Disc Prosthesis|
12026346|NCT00394732|Behavioral|Multidisciplinary rehabilitation program|
12026347|NCT00394706|Device|Impedance Threshold Device (ITD)|Use of Impedance Threshold Device (ITD)
12026348|NCT00394706|Device|Sham ITD|Sham ITD
12026349|NCT00394706|Other|Analyze early|Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.
12026350|NCT00394706|Other|Analyze later|Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
12026351|NCT00394693|Genetic|Adenovirus Interferon gamma|intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.
12026352|NCT00394667|Drug|Tesofensine|
12026353|NCT00394654|Biological|MEDI-528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion
12026354|NCT00394654|Other|Placebo|Placebo administered as a single intravenous infusion
12026355|NCT00394641|Behavioral|listening to music / stories via stereophonic headphones|
12026356|NCT00394628|Drug|AQ4N|
12026357|NCT00394628|Drug|Temozolomide|
12026358|NCT00394628|Procedure|Radiotherapy|
12026359|NCT00394615|Procedure|Metabolic Imaging|
12026360|NCT00394602|Behavioral|Interview|Interview regarding perceptions of side effects that are related to chemoradiation treatment.
12026361|NCT00394602|Other|Questionnaire|3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete.
12026362|NCT00394589|Drug|Infliximab Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks
12026363|NCT00394589|Drug|Infliximab Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks
12026364|NCT00394589|Drug|Infliximab Control|Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks
12026365|NCT00394576|Behavioral|Internet-based nutrition module along with usual care|usual care plus Internet-based nutrition module
12026366|NCT00394576|Behavioral|usual care|usual care
12026367|NCT00394563|Drug|RN624 (PF-04383119)|10 mcg/kg
12026368|NCT00394563|Drug|RN624 (PF-04383119)|25 mcg/kg
12026369|NCT00394563|Drug|RN624 (PF-04383119)|50 mcg/kg
12026370|NCT00394563|Drug|RN624 (PF-04383119)|100 mcg/kg
12026371|NCT00394563|Drug|RN624 (PF-04383119)|200 mcg/kg
12026372|NCT00394563|Drug|placebo|
12026373|NCT00394550|Procedure|supraglottoplasty with laser|"Polysomnogram, fiberoptic flexible laryngoscopy, adenotonsillectomy, direct laryngoscopy, bronchoscopy, laser supraglottoplasty, general anesthesia, a proton-pump inhibitor ibuprofen, acetaminophen with codeine without alcohol, or other narcotic containing medication, antibiotic, possible use of other analgesics per anesthesia None of these procedures are new or experimental. Our investigation pertains to a broader use of the laser supraglottoplasty to include children with obstructive sleep apnea and laryngomalacia, as opposed to the more traditional use of laser supraglottoplasty for only severe laryngomalacia in young children"
12026374|NCT00394550|Procedure|supraglottoplasty with laser|laser excision of laryngomalacia (floppy tissue) on one side of the supraglottis
12026375|NCT00394537|Drug|Labetalol 10mg iv|
12026376|NCT00394524|Device|Glucommander|Glucommander is a Computer-guided Intravenous (IV) insulin infusion protocol used for glycemic control in inpatients. This algorithm directs the administration of IV insulin in response to Blood Glucose (BG) measurement at the patient's bedside. In this study, the Glucommander program was loaded into a PalmOne (Zire 31, Tungsten E2 by Palm Inc.) handheld personal digital assistant (PDA) device. During the infusion, the nurse entered BG levels into the system and the computer recommended the insulin infusion rate and a variable time to check the next glucose testing. An alarm prompted the scheduled glucose check. The insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG- 60).
12026377|NCT00394524|Other|Standard insulin infusion algorithm|Standard insulin infusion Algorithm is a standard paper form insulin infusion algorithm. The algorithm is divided into four columns based on empirically determined insulin sensitivity. The first column was for the most insulin-sensitive patients, and the fourth column was for the most insulin resistant patients. The majority of patients are started in the algorithm 1 column. Insulin resistant patients, such as those receiving glucocorticoids or receiving >80 units of insulin per day as outpatients, started in the algorithm 2 column. The insulin infusion rate was determined by the patient's BG level and was measured hourly until the patient was stable and within the target range. If BG targets were not achieved and the BG had not decreased by at least 60 mg/dL in the preceding hour, the patient was moved to the next column.
12026378|NCT00394511|Procedure|low-LET photon therapy|
12026379|NCT00394498|Drug|Granulocyte Colony Stimulating Factor|
12026380|NCT00394485|Drug|Procaterol|
12026381|NCT00394485|Drug|Tiotropium|
12026382|NCT00394472|Drug|AZD3355|
12026383|NCT00394459|Device|Perifix Epidural Anaesthesia Catheter|Epidural Catheter
12026384|NCT00394459|Device|Perifix Standard|Perifix Standard
12026385|NCT00394459|Device|Perifix New|Perifix New
12026386|NCT00394446|Drug|MPC-6827|2-hour intravenous infusion given once weekly for 3 consecutive weeks on a 28 day cycle
12026387|NCT00394433|Drug|Bevacizumab|
12026388|NCT00394433|Drug|Docetaxel|
12026389|NCT00394433|Drug|Cisplatin|
12026390|NCT00394433|Drug|Irinotecan|
12026391|NCT00394420|Behavioral|Telephone Quitline|
12026392|NCT00394407|Drug|sliding scale regular insulin|SSRI acqhs
12026393|NCT00394407|Drug|glargine basal insulin and glulisine prandial insulin|glargine insulin once a day and glulisine insulin three times a day as long as patient eating
12026394|NCT00394394|Drug|Amiloride 2,5/d or Enalapril/d 10 mg|
12026395|NCT00394381|Procedure|Infusion of autologous CIK cells|Autologous CIK cells will be infused at timed intervals after autologous transplant for AML for group 1 patients, and with or without some cytoreduction treatment for group 2 patients
12026396|NCT00394368|Drug|beclomethasone dipropionate plus formoterol fumarate combination|
12026397|NCT00394368|Drug|fluticasone propionate plus salmeterol xinafoate combination|
12026398|NCT00394355|Drug|mometasone furoate dry powder inhaler|400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
12026399|NCT00394355|Drug|mometasone furoate dry powder inhaler|200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
12026400|NCT00394355|Drug|fluticasone propionate hydrofluoroalkane (HFA)|250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year
12026401|NCT00394355|Drug|montelukast|10 mg given once daily in the evening by mouth for 1 year.
12026402|NCT00394329|Drug|Beclomethasone dipropionate|Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
12026403|NCT00394329|Drug|Beclomethasone dipropionate|Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
12026404|NCT00394329|Drug|Albuterol sulfate|Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
12026405|NCT00394316|Drug|Phagocyte Oxidase Subunit Transduced CD34 Hematopoietic Stem Cells|
12026406|NCT00394303|Drug|Intraoperative continuous insulin infusion|Nomogram specified in appendix
12026407|NCT00394303|Other|Control|Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels <200 mg.dl, reflecting current practice.
12026408|NCT00394290|Device|Continuous Positive Pressure|Nighttime continuous positive pressure device, to be used every day
12026409|NCT00394277|Drug|peginterferon alfa-2a|180 µg sc weekly for 48 weeks
12026410|NCT00394277|Drug|Ribavirin|1200 mg po daily for 48 weeks
12026411|NCT00394277|Drug|peginterferon alfa-2a|360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
12026412|NCT00394277|Drug|Ribavirin|1400-1600 mg po daily for 48 weeks
12026413|NCT00394264|Procedure|Soft Tissue|
12026414|NCT00394264|Procedure|Myofascial release|
12026415|NCT00394264|Procedure|Counterstrain|
12026416|NCT00394264|Procedure|Muscle energy|
12026417|NCT00394264|Procedure|Sacro-iliac articulation|
12026418|NCT00394264|Procedure|High-velocity, low amplitude|
12026419|NCT00394251|Drug|Adriamycin and Cytoxan (AC)|Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m^2 intravenous, plus Cytoxan 600 mg/m^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8).
12026420|NCT00394251|Drug|ABI-007|260 mg/m^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
12026421|NCT00394251|Drug|Taxol|175 mg/m^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
12026422|NCT00394251|Drug|Bevacizumab|10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46).
12026423|NCT00394251|Drug|pegfilgrastim|6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.
12026424|NCT00394238|Procedure|Ultrasonographic imaging|
12026425|NCT00394225|Drug|Oxygen|
12026426|NCT00394225|Drug|Helium|
12026427|NCT00394212|Device|Transoral Suturing|suturing of anastomosis
12026428|NCT00394212|Other|Sham Endoscopy|suturing not performed
12026554|NCT00393211|Drug|MK0663, Etoricoxib / Duration of Treatment : 12 Weeks|
12026429|NCT00394199|Drug|Fluticasone propionate/Formoterol Fumarate 100/10|FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026430|NCT00394199|Drug|Fluticasone propionate 100|Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026431|NCT00394199|Drug|Formoterol fumarate 10|Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026432|NCT00394186|Drug|GW427353|
12026433|NCT00394186|Drug|Placebo|
12026434|NCT00394173|Drug|DNK333|DNK333 25mg b.i.d. given orally for 4 weeks
12026435|NCT00394173|Drug|Placebo|Matching placebo
12026436|NCT00394160|Drug|MK0476, Montelukast Sodium /Duration of Treatment : 14 Days|
12026437|NCT00394147|Drug|pemetrexed|pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
12026438|NCT00394147|Drug|gemcitabine|gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
12026439|NCT00394134|Behavioral|Interview|Interviews to describe the sun exposure and sun protection practices of patients and their children.
12026440|NCT00394121|Drug|Fluticasone propionate/formoterol fumarate|
12026441|NCT00394108|Procedure|Determination of neuropsychological status|
12026442|NCT00394095|Drug|Topiramate|Oral topiramate 300-400mg/day for 12 weeks
12026443|NCT00394095|Drug|Placebo|Matched placebo to Experimental arm
12026444|NCT00394082|Drug|ABI-007|125 mg/m^2 of ABI-007 administered by intravenously (IV) over 30 minutes on days 1, 8 and 15 of each 28 day cycle.
12026445|NCT00394082|Drug|Bevacizumab|Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1.
12026446|NCT00394069|Drug|MK-0476, montelukast sodium|Duration of Treatment: 14 Days
12026447|NCT00394056|Drug|Vestipitant|NK1 receptor antagonist
12026448|NCT00394056|Drug|Vestipitant + Paroxetine|NK1 receptor antagonist and SSRI
12026449|NCT00394056|Other|Placebo|Placebo
12026450|NCT00394043|Procedure|Osteopathic Manipulative Treatment|A protocol of specific Osteopathic manipulative techniques was used.
12026451|NCT00394043|Procedure|Placebo Sub-Therapeutic Ultrasound|Sub-therapeutic ultrasound was applied in a standardized method.
12026452|NCT00394030|Drug|GSK716155 subcutaneous injections|GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
12026453|NCT00394017|Behavioral|Reminder letters|3 mailed reminder letters
12026454|NCT00393991|Drug|Fluticasone propionate/formoterol fumarate 100/10|FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026455|NCT00393991|Drug|Fluticasone propionate 100|Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026456|NCT00393991|Drug|Formoterol fumarate 10|Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026457|NCT00393991|Drug|Placebo|Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
12026458|NCT00393978|Drug|Quetiapine and placebo|placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).
12026459|NCT00393978|Drug|Quetiapine and Topiramate|topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
12026460|NCT00393965|Drug|MPC-6827|2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.
12026461|NCT00393952|Drug|Fluticasone propionate/Formoterol fumarate 250/10|FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026462|NCT00393952|Drug|Placebo|Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
12026463|NCT00393952|Drug|Fluticasone propionate/Formoterol fumarate 100/10|FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026464|NCT00393952|Drug|Fluticasone propionate 250|Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026465|NCT00393952|Drug|Formoterol fumarate 10|Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
12026466|NCT00393939|Drug|Sunitinib malate|Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
12026467|NCT00393939|Drug|Taxotere|Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
12026468|NCT00393926|Device|TheraDrive Assistive Device|
12026469|NCT00393926|Procedure|Rote Therapy versus Fun Therapy|
12026470|NCT00393913|Device|Continuous Positive Airway Pressure (CPAP)|Positive airway pressure delivered via a nasal mask titrated to a therapeutic level to eliminate all sleep disordered breathing to be used every night for 4-6 weeks.
12026471|NCT00393887|Device|Biodesign IHM|Biodesign IHM is placed to reinforce the hernia repair
12026472|NCT00393887|Device|Polypropylene mesh|Polypropylene mesh is used to reinforce the hernia repair.
12026506|NCT00393627|Behavioral|Sleep Education Program|The Sleep Education Program (SEP) is conducted by a licensed MS- or PhD-level mental health professional experienced in working with persons with dementia and their caregivers. The therapist meets with the AFH owner/operator and staff for four weekly sessions at the AFH. The SEP content includes information about the causes of sleep problems in dementia, and provides staff with assistance in developing customized resident behavioral sleep plans focused on environmental (light and noise), dietary (eliminating caffeine and excessive nighttime fluids), and sleep scheduling (reducing afternoon/ evening napping; consistent, appropriate bed and rising times) factors that are commonly associated with resident nighttime awakenings. A written manual is used.
12026507|NCT00393614|Drug|levetiracetam|20 mg pr. kg a day
12026473|NCT00393874|Behavioral|Behavioral Sleep Intervention|Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, nightmares, and sleep avoidance behaviors. The rationale for imagery rehearsal will then be presented, and the technique will be practiced once. Strategies for managing intrusive thoughts and images during the practice of imagery rehearsal will be discussed. Participants will be instructed to practice this technique at least three times each day for the duration of the treatment phase. During the second 45-minute session (Week 3), sleep schedules extracted from the pre-intervention sleep diary will be used to identify goals to reduce insomnia, i.e., for sleep restricted schedules, and activities to be performed out of bed when awake.
12026474|NCT00393874|Drug|Prazosin|Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal communication, February 4, 2005). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary. Medication will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
12026475|NCT00393874|Drug|Placebo|Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
12026476|NCT00393861|Drug|Bevacizumab and Oxaliplatin|Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
12026477|NCT00393848|Drug|Essential amino acid supplement|15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
12026478|NCT00393848|Drug|Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
12026479|NCT00393848|Drug|Placebo|Placebo for Ketoconazole
12026480|NCT00393835|Drug|Azithromycin SR|
12026481|NCT00393822|Drug|palifermin|dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles
12026482|NCT00393822|Drug|placebo|one bolus IV injection at 120 μg/kg/day of matched placebo
12026483|NCT00393809|Drug|DTA-H19|
12026484|NCT00393796|Drug|SUTENT|"50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to crossover and receive SU011248."
12026485|NCT00393796|Other|Placebo|
12026486|NCT00393783|Biological|MAB HER 2 (HERCEPTIN)|Rat HER2 DNA will be delivered intramuscularly at four different dose levels (0.5mg, 1mg, 3mg, or 6mg) during weeks 1, 4, 7, 10 and 13 for five injections.
12026487|NCT00393770|Drug|L-acetylcarnitine|250-500 mg/kg/die.
12026488|NCT00393744|Drug|pristinamycin|50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
12026489|NCT00393744|Drug|amoxicillin|50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
12026490|NCT00393731|Drug|Misoprostol|
12026491|NCT00393731|Drug|oxytocin|
12026492|NCT00393718|Drug|liraglutide|0.9 mg/day. Injected s.c. (under the skin) once daily.
12026493|NCT00393718|Drug|glibenclamide|1.25-2.5 mg tablet. Given orally once or twice daily.
12026494|NCT00393718|Drug|placebo|liraglutide placebo. Injected s.c. (under the skin) once daily.
12026495|NCT00393718|Drug|placebo|glibenclamide placebo. Given orally once or twice daily.
12026496|NCT00393705|Drug|Insulin Biphasic Aspart 30/70|Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
12026497|NCT00393705|Drug|insulin lispro LM|Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.
12026498|NCT00393705|Drug|insulin lispro MM|Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks
12026499|NCT00393705|Drug|insulin lispro LM|Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
12026500|NCT00393679|Drug|amodiaquine-artesunate (ASAQ)|A fix-dose combination tablet containing artesunate-amodiaquine in three different dosages, to be used according to patient age and weight: 25mg/67.5mg; 50mg/135mg; 100mg/270mg
12026501|NCT00393679|Drug|dihydroartemisinin-piperaquine (DHAPQ)|DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively.
12026502|NCT00393679|Drug|artemether-lumefantrine (AL)|Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.
12026503|NCT00393679|Drug|Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)|"Lapdap tablets contain 15/18.75mg or 80/100mg of Chlorproguanil Hydrochloride and Dapsone, respectively. Arsumax® tablets contain 50mg Artesunate.
~TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008."
12026504|NCT00393653|Procedure|N-of-1 prescription method|
12026505|NCT00393640|Procedure|Early and regular breast milk expression|Breast pump given to be used on regular intervals
12026552|NCT00393250|Other|Hypnosis|Subjects receive hypnosis (experimental intervention) during 4 weeks of face-to-face encounters with a physician trained in hypnosis. For 6 weeks following the instruction period, the participants will perform daily self- hypnosis using customizable digital media.
12026553|NCT00393250|Other|Control|Subjects in the control arm of the study will receive face-to-face education regarding sickle cell disease for the same length and frequency as the treatment group hypnosis encounters before crossing over to the experimental intervention arm of the study
12026508|NCT00393575|Behavioral|Community Mobilization|The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program.
12026509|NCT00393562|Drug|modafinil|
12026510|NCT00393562|Drug|methylphenidate|
12026511|NCT00393549|Device|NeuroPath|
12026512|NCT00393536|Behavioral|Educational outreach visiting|
12026513|NCT00393523|Biological|Comparator: Modified Process Hepatitis B Vaccine|Single dose 5 µg/0.5ml modified process hepatitis B vaccine
12026514|NCT00393523|Biological|Comparator: Comparator: ENGERIX-B|Single dose 10 µg/0.5ml ENGERIX-B
12026515|NCT00393510|Drug|TCM|"The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
~The formula consisted of 12 herbs, viz:
~Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae"
12026516|NCT00393510|Drug|Placebo|"Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
~The placebo was made with starch and colouring materials."
12026517|NCT00393497|Drug|bevacizumab|Bevacizumab 15 mg/kg IV every 21 days
12026518|NCT00393484|Drug|Entecavir|Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)
12026519|NCT00393484|Drug|Lamivudine Placebo|Capsules, Oral, 0 mg, once daily (0-96 weeks)
12026520|NCT00393484|Drug|Lamivudine|"Capsules, Oral, 100 mg, once daily (0-96 weeks)
~Tablets, Oral, 100 mg, once daily (96-240 weeks)"
12026521|NCT00393484|Drug|Entecavir Placebo|Tablets, Oral, 0 mg, once daily (0-96 weeks)
12026522|NCT00393471|Drug|Etanercept|
12026523|NCT00393458|Drug|Indacaterol|Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
12026524|NCT00393458|Drug|Formoterol|Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
12026525|NCT00393458|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
12026526|NCT00393458|Drug|Placebo to formoterol|Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
12026527|NCT00393445|Drug|GLP-1 control|intravenous infusion of GLP-1
12026528|NCT00393445|Drug|GLP-1 and Exendin(9-39) 300|intravenous infusion of exendin(9-39) at 300 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
12026529|NCT00393445|Drug|saline control|intravenous infusion of saline
12026530|NCT00393445|Drug|GLP-1 and Exendin(9-39) 600|intravenous infusion of exendin(9-39) at 600 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
12026531|NCT00393445|Drug|GLP-1 and Exendin(9-39) 900|intravenous infusion of exendin(9-39) at 900 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
12026532|NCT00393445|Drug|GLP-1 and Exendin(9-39) 1200|intravenous infusion of exendin(9-39) at 1200 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
12026533|NCT00393419|Behavioral|Comprehensive pharmacy care program|
12026534|NCT00393393|Drug|intra-articular injection of Hylan G-F 20|
12026535|NCT00393380|Drug|Parathyroid Hormone (teriparatide)|Day +1: PTH 40 mcg, Day +2: PTH 60 mcg, Day +3: PTH 80 mcg, Day +4 to Day +29 or until ANC>2000/microL: PTH 100 mcg
12026536|NCT00393367|Drug|Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg|Patients randomized to budesonide inhalation suspension (BIS) receive 2 nebulized albuterol sulfate (5mg/mL) doses (2mL =10mg for patients over 20kg, 1.5mL =7.5mg for patients 10-20kg) mixed with 8mL (2mg) of BIS(0.5mg/2mL). The albuterol sulfate and BIS mixture is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.
12026537|NCT00393367|Drug|Prednisolone, prednisone, or methylprednisolone|All patients are given 2mg/kg of systemic corticosteroids (max 60mg). Patients who can tolerate pills are given oral prednisone, those who cannot are given oral prednisolone, and those who cannot tolerate oral medications are given IV methylprednisolone.
12026538|NCT00393367|Drug|Albuterol, ipratropium bromide|While guardians are approached for possible participation, patients are given a single nebulized dose of albuterol sulfate (5mg/mL) mixed with ipratropium bromide (500mcg/2.5mL). Patients who weigh 10-20kg receive 3.75mg of albuterol. Patients over 20kg receive 5mg of albuterol. All patients receive 500mcg of ipratropium bromide. Albuterol sulfate and ipratropium bromide are delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.
12026539|NCT00393367|Drug|Ipratropium bromide|500 mcg/2.5mL. All patients receive a final dose of ipratropium bromide after the intervention or placebo. The ipratropium bromide is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM) with an oxygen flow rate of 8L/minute via a tight-fitting face mask.
12026540|NCT00393354|Drug|MK0663, Etoricoxib / Duration of Treatment : 12 Weeks|
12026541|NCT00393354|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks|
12026542|NCT00393341|Procedure|Blood Draw|Blood sample will be drawn from a vein in the arm.
12026543|NCT00393328|Drug|Atazanavir + Ritonavir|Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.
12026544|NCT00393328|Drug|Atazanavir + Ritonavir|Capsules, Oral, ATV 300mg as single cap + RTV 100mg, single dose, 7 days washout.
12026545|NCT00393315|Device|paclitaxel coated balloon catheter|
12026546|NCT00393302|Procedure|HIV screening in pregnancy|
12026547|NCT00393289|Behavioral|Calcium controlled diet|
12026548|NCT00393276|Biological|Twinrix|Combined hepatitis A and hepatitis B immunization
12026549|NCT00393276|Biological|Decavac|Diphtheria and tetanus toxoid vaccine
12026550|NCT00393263|Drug|pimecrolimus and clobetasol|
12026551|NCT00393263|Drug|clobetasol 0.05% cream|twice daily for three months
12026555|NCT00393211|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks|
12026556|NCT00393198|Drug|Levonorgestrel (Mirena, BAY86-5028)|Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.
12026557|NCT00393198|Drug|Cytotec|Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
12026558|NCT00393198|Drug|Placebo|Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.
12026559|NCT00393185|Biological|Non-myeloablative Hematopoietic Stem Cell Transplantation|autologous Hematopoietic Stem Cell Transplantation
12026560|NCT00393172|Behavioral|exercise|5 days per week exercise for 4 months
12026561|NCT00393159|Device|Ear Popper|
12026562|NCT00393146|Drug|GW856553|Study drug
12026563|NCT00393120|Drug|INCB009471|100mg SR (sustained release) orally once daily
12026564|NCT00393120|Drug|INCB009471|300mg SR (sustained release) orally once daily
12026565|NCT00393120|Drug|Placebo comparator|Orally once daily
12026566|NCT00393107|Drug|rituximab|
12026567|NCT00393107|Drug|rituximab,fludarabine, cyclophosphamide|
12026568|NCT00393094|Biological|Bevacizumab|10 mg/kg intravenous injection
12026569|NCT00393094|Drug|Irinotecan hydrochloride|125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle
12026570|NCT00393068|Drug|Erlotinib|Erlotinib
12026571|NCT00393068|Drug|Bevacizumab|Bevacizumab
12026572|NCT00393068|Drug|Paclitaxel|Paclitaxel
12026573|NCT00393068|Drug|Carboplatin|Carboplatin
12026574|NCT00393068|Drug|5-FU|5-FU
12026575|NCT00393068|Procedure|Radiation therapy|Radiation therapy
12026576|NCT00393068|Procedure|Surgery|Surgery
12026577|NCT00393055|Dietary Supplement|xylitol|1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years
12026578|NCT00393055|Dietary Supplement|inactive lozenge|1g inactive lozenge, dissolved in mouth. Five/day for three years
12026579|NCT00393042|Drug|Dexmethylphenidate|10, 20, 25-30 mg.
12026580|NCT00393042|Drug|Mixed Amphetamine Salts, ER|10, 20, 25-30
12026581|NCT00393042|Drug|placebo|randomized placebo week during each 4 week period
12026582|NCT00393029|Biological|anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes|Peripheral blood lymphocytes are harvested by lymphapheresis and engineered to express a T cell receptor that binds to P53.
12026583|NCT00393029|Biological|aldesleukin|720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days
12026584|NCT00393029|Biological|filgrastim|Beginning on day 1 or 2, administered subcutaneously at a dose of 5 mcg/kg/day (not to exceed 300 mcg/day); continue daily until neutrophil count > 1.0 x 10^9/L x 3 days or > 5.0 x 10^9/L.
12026585|NCT00393029|Drug|cyclophosphamide|60 mg/kg/day x 2 days intravenously in 250ml dextrose 5% in water (D5W) with mesna 15 mg/kg/day x 2 days over 1 hour.
12026586|NCT00393029|Drug|fludarabine phosphate|25 mg/m2/day intravenously piggyback (IVPB) daily over 30 minutes for 5 days.
12026587|NCT00393003|Device|Closed-loop anesthesia system|
12026588|NCT00392990|Drug|Regimen A|Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
12026589|NCT00392990|Drug|Regimen B|Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
12026590|NCT00392977|Dietary Supplement|remove Mn from PN if evidence of increased brain Mn on MRI|trace element cocktail will be withheld and zinc, copper and chromium added to PN individually.
12026591|NCT00392951|Drug|sirolimus|Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)
12026592|NCT00392938|Drug|antiandrogen therapy|
12026593|NCT00392938|Drug|docetaxel|
12026594|NCT00392938|Diagnostic Test|C-11 acetate PET scan|
12026595|NCT00392938|Diagnostic Test|F-18 FDG PET scan|
12026596|NCT00392938|Diagnostic Test|Tc-99m bone scan|
12026597|NCT00392938|Diagnostic Test|CT scan of the chest, abdomen and pelvis|
12026598|NCT00392925|Drug|pramlintide acetate 360 mcg|subcutaneous injection, twice a day, 360mcg
12026599|NCT00392925|Drug|metreleptin|subcutaneous injection, twice a day, 5mg
12026600|NCT00392925|Drug|placebo-pramlintide 600 uL|twice a day
12026601|NCT00392925|Drug|placebo-metreleptin 1 mL|twice a day
12026602|NCT00392925|Drug|Pramlintide acetate 180 mcg|subcutaneous injection twice a day, 180 mcg
12026603|NCT00392912|Drug|AndroGel (Solvay Pharmaceuticals)|Testosterone Replacement Therapy: AndroGel 1% 5g packets (Solvay Pharmaceuticals). Initial dosage: 5g daily (1 packet). Patients who do not achieve eugonadal levels of 400-600 mg/dL within 2 weeks will be raised to 10g daily.
12026604|NCT00392899|Drug|UFT adjuvant chemotherapy|UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
12026605|NCT00392886|Drug|carboplatin|Given IV
12026606|NCT00392886|Drug|cisplatin|Given IV
12026607|NCT00392886|Drug|cyclophosphamide|Given IV
12026608|NCT00392886|Drug|etoposide|Given IV and orally
12026609|NCT00392886|Drug|methotrexate|Given IV
12026610|NCT00392886|Drug|temozolomide|Given orally
12026611|NCT00392886|Drug|thiotepa|Given IV
12026612|NCT00392886|Drug|vincristine sulfate|Given IV
12026613|NCT00392886|Procedure|autologous bone marrow transplantation|Given on day 0
12026614|NCT00392886|Procedure|autologous hematopoietic stem cell transplantation|Given on day 0
12026615|NCT00392886|Procedure|peripheral blood stem cell transplantation|Given on day 0
12026616|NCT00392886|Radiation|radiation therapy|Some patients undergo radiation therapy once daily, 5 days a week for 4-6 weeks.
12026733|NCT00392197|Drug|Aripiprazole|1 or 2 times a day, p.o., 6 - 24mg a day
12026734|NCT00392184|Procedure|Accelerated partial breast irradiation|
12026617|NCT00392873|Behavioral|EAMD+Calories|During the 12 month intervention, volunteers in the Increased calorie intake group will follow a modified dietary plan designed to achieve and maintain a target level of 20-30% above their previously determined baseline, in an effort to achieve a chronic energy surplus of +20-30% over their baseline energy requirements.
12026618|NCT00392860|Device|Natural-Fit|Ergonomic handrim for wheelchairs
12026619|NCT00392860|Device|PalmRim|Ergonomic handrim for wheelchair
12026620|NCT00392860|Device|Handrim Control Group|Participants were given a new standard handrim to test. This intervention group is the control group.
12026621|NCT00392847|Behavioral|Promoting Parental Skills and Enhancing Attachment|The first group will receive routine follow-up as currently provided by national community health and social services.
12026622|NCT00392847|Behavioral|had home visits by community workers during pregnancy|had home visits by community workers during pregnancy to the child's second birthday.
12026623|NCT00392834|Biological|filgrastim|given subcutaneously
12026624|NCT00392834|Biological|pegfilgrastim|given subcutaneously
12026625|NCT00392834|Biological|rituximab|given IV
12026626|NCT00392834|Drug|cyclophosphamide|given IV
12026627|NCT00392834|Drug|cytarabine|given intrathecally
12026628|NCT00392834|Drug|doxorubicin hydrochloride|given IV
12026629|NCT00392834|Drug|etoposide|given IV
12026630|NCT00392834|Drug|ifosfamide|given IV
12026631|NCT00392834|Drug|leucovorin calcium|given IV
12026632|NCT00392834|Drug|liposomal cytarabine|given intrathecally
12026633|NCT00392834|Drug|methotrexate|given intrathecally
12026634|NCT00392834|Drug|therapeutic hydrocortisone|given intrathecally
12026635|NCT00392834|Drug|vincristine sulfate|given IV
12026636|NCT00392821|Drug|Sorafenib|Sorafenib
12026637|NCT00392821|Drug|RAD001|RAD001
12026638|NCT00392808|Biological|conjugated polysaccharide menC vaccine|Booster vaccine dose at 14 to 18 months.
12026639|NCT00392782|Biological|anti-thymocyte globulin|Rabbit thymoglobulin will be given intravenously at a dose of 2.5 mg/kg on days -5,-4, -3, and -2. The first dose of thymoglobulin will be given over six (6) hours and subsequent doses over four (4) or more hours as tolerated or, per institutional anti-thymocyte globulin (ATG) administration guidelines.
12026640|NCT00392782|Drug|fludarabine phosphate|Fludarabine 40 mg/m^2/day intravenously (IV) over 30-60 minutes on days -7,-6,-5,-4,-3 (total dose 200 mg/m^2).
12026641|NCT00392782|Drug|thiotepa|Thiotepa 5 mg/kg/day intravenously (IV) over 4 hours on days -8, -7 (total dose 10 mg/kg).
12026642|NCT00392782|Procedure|peripheral blood stem cell transplantation|Peripheral Blood Stem Cell (PBSC) Infusion. All patients will receive granulocyte colony-stimulating factor (G-CSF)-mobilized PBSC on day 0 (or day+1 when available) following CD34 cell selection for ex vivo T cell removal. PBSC is infused via a central venous catheter using blood infusion tubing.
12026643|NCT00392782|Radiation|total-body irradiation|The total-body irradiation (TBI) will be given in 2 fractions of 400 cGy each administered on day -10 and -9 via anterior and posterior fields for a total dose of 800 cGy.
12026644|NCT00392769|Drug|Cetuximab|Initial Dose = 400 mg/m^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m^2 IV Over 60 Minutes.
12026645|NCT00392756|Drug|gonadotropin releasing hormone (GnRH)|pulsatile GnRH is delivered to adult men (18+ yrs) via portable microinfusion pump. A small dose (30 microliters) is delivered subcutaneously every 120 minutes. The initial dose is 25 ng/Kg which is increased until normal serum testosterone levels are achieved.
12026646|NCT00392743|Procedure|pet/spect scan|
12026647|NCT00392730|Dietary Supplement|Remove Mn from PN if evidence of increased brain Mn on MRI|Withhold Mn-containing trace element cocktail and add zinc, copper and chromium individually to PN
12026648|NCT00392717|Drug|Atorvastatin|
12026649|NCT00392717|Drug|Fish oils|
12026650|NCT00392704|Drug|Bevacizumab|"Induction Treatment:
~Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 & Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.
~Combined Modality Treatment:
~Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy"
12026651|NCT00392704|Drug|Erlotinib|"Induction Treatment:
~Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 & Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.
~Combined Modality Treatment:
~Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy"
12026652|NCT00392704|Drug|Paclitaxel|"Neoadjuvant: 200 mg/m2 IV, 1-3 hour infusion, Days 1 and 22
~Combined Modality: 50 mg/m2 IV, 1 hour IV infusion, weekly x6, beginning day 1 of radiation therapy"
12026653|NCT00392704|Drug|5-FU|Neoadjuvant: 200 mg/m2 24 hour continuous infusion days 1-43
12026654|NCT00392704|Radiation|Radiation Therapy|Combined Modality Therapy: 1.8 Gy/day, Monday-Friday, total dose 68.4 Gy
12026655|NCT00392691|Drug|ibritumomab tiuxetan|185 MBq (5mCi) of 111In-Zevalin will be used for radioimaging. and the dose is 14.8 MBq/kg (0.4 mCi/kg) total body weight of 90Y-Zevalin (max. 1184 MBq or 32 mCi at patients > 80kg) for imaging.
12026656|NCT00392691|Drug|rituximab|250 mg/m2
12026657|NCT00392691|Drug|melphalan|"Dose level 1: 100 mg/m2
~Dose level 2: 140 mg/m2
~Dose level 3: 170 mg/m2
~Dose level 4: 200 mg/m2"
12026658|NCT00392691|Drug|vinorelbine tartrate / G-CSF|on day 1: 35 mg/m2 day 4-8 (longer if required) G-CSF 5 μg/kg s.c. morning and 5 μg/kg s.c. evening for at least 5 days
12026735|NCT00392171|Drug|Temozolomide|Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression
12026736|NCT00392158|Device|Closed-loop anesthesia system|
12026737|NCT00392145|Drug|Standard IV rehydration|A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
12026659|NCT00392691|Procedure|autologous hematopoietic stem cell harvesting and transplantation|"Optimal mobilization usually takes place on day 8. A minimum of 2.5x106 CD34+ cells/kg should be collected (optimal 5x106 CD34+ cells/kg). If not enough CD34+ cells can be collected on day 8, it is recommended to continue with G-CSF until a sufficient collection (a minimum of 2.5x106 CD34+ cells/kg) can be obtained.
~Stem cells will be reinfused approximately 24 hours after the melphalan administration. The infusion will be performed with a minimum of 2.5x106 CD34+ cells/kg body weight according to local guidelines. G-CSF (5 μg/kg/d) will be given from day 5 and continued until neutrophils > 0.5x109/l for at least 2 consecutive days."
12026660|NCT00392678|Drug|Salsalate|Placebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
12026661|NCT00392678|Drug|Placebo|Placebo to Salsalate
12026662|NCT00392665|Drug|Bevacizumab|Given intravenously on day one of each 3 week cycle
12026663|NCT00392665|Drug|erlotinib|Given orally once a day
12026664|NCT00392665|Drug|Sulindac|Given orally twice a day
12026665|NCT00392652|Drug|oral microencapsulated diindolylmethane|Given PO
12026666|NCT00392639|Procedure|Comparison of 2 cooling procedures|Comparison of 2 cooling procedures
12026667|NCT00392613|Procedure|Strict versus lenient rate control|
12026668|NCT00392587|Drug|GW856553|
12026669|NCT00392574|Drug|Prulifloxacin|Tablet
12026670|NCT00392574|Drug|Placebo|Tablet
12026671|NCT00392561|Dietary Supplement|Selenium|200 ug Selenium daily
12026672|NCT00392561|Dietary Supplement|vitamin E|100 mg Vitamin E daily
12026673|NCT00392535|Radiation|conventional radiotherapy 74 Gy delivered in 37 fractions|
12026674|NCT00392535|Radiation|hypofractionated radiation therapy 60 Gy in 20 fractions|
12026675|NCT00392535|Radiation|hypofractionated radiation therapy 57 Gy in 19 fractions|
12026676|NCT00392522|Drug|50% Nitrous Oxide and 50% Oxygen (MEOPA)|
12026677|NCT00392509|Procedure|ALDH-br bone marrow cells vs. mononuclear bone marrow cells|Surgery
12026678|NCT00392496|Drug|sunitinib malate|Given orally
12026679|NCT00392470|Biological|cetuximab|
12026680|NCT00392470|Drug|irinotecan hydrochloride|
12026681|NCT00392470|Procedure|conventional surgery|
12026682|NCT00392470|Procedure|neoadjuvant therapy|
12026683|NCT00392470|Radiation|3-dimensional conformal radiation therapy|
12026684|NCT00392470|Radiation|intensity-modulated radiation therapy|
12026685|NCT00392457|Drug|ketoconazole|loading dose of 1g followed by a maintenance dose of 400 mg PO QID for 7 days
12026686|NCT00392457|Drug|gonadotropin releasing hormone (GnRH)|Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels)
12026687|NCT00392444|Drug|sunitinib malate|Given orally
12026688|NCT00392431|Drug|amiodarone|
12026689|NCT00392418|Drug|Multiple micronutrient supplement (iron)|
12026690|NCT00392405|Drug|3 amps of sodium bicarbonate mixed in one liter of D5W|
12026691|NCT00392392|Drug|nab-paclitaxel|ABI-007
12026692|NCT00392392|Drug|Bevacizumab|Bevacizumab
12026693|NCT00392392|Drug|Trastuzumab|Trastuzumab
12026694|NCT00392379|Drug|Nicotine Lozenges|Nicotine lozenges, 4 mg
12026695|NCT00392379|Drug|Placebo lozenge|Placebo lozenge
12026696|NCT00392366|Device|MR-guided Laser Interstitial Thermal Therapy System|
12026697|NCT00392353|Drug|Azacitidine|Given SC
12026698|NCT00392353|Other|Laboratory Biomarker Analysis|Correlative studies
12026699|NCT00392353|Other|Pharmacological Study|Correlative studies
12026700|NCT00392353|Drug|Vorinostat|Given PO
12026701|NCT00392340|Biological|filgrastim|
12026702|NCT00392340|Drug|doxorubicin hydrochloride|
12026703|NCT00392340|Drug|topotecan hydrochloride|
12026704|NCT00392340|Drug|vincristine sulfate|
12026705|NCT00392327|Drug|Carboplatin|Given IV
12026706|NCT00392327|Drug|Cisplatin|Given IV
12026707|NCT00392327|Drug|Cyclophosphamide|Given IV
12026708|NCT00392327|Biological|Filgrastim|Given IV or SC
12026709|NCT00392327|Drug|Isotretinoin|Given PO
12026710|NCT00392327|Other|Laboratory Biomarker Analysis|Correlative studies
12026711|NCT00392327|Other|Quality-of-Life Assessment|Ancillary studies
12026712|NCT00392327|Radiation|Radiation Therapy|Undergo radiation therapy
12026713|NCT00392327|Drug|Vincristine Sulfate|Given IV
12026714|NCT00392314|Other|PET/CT post 2 cycles of chemotherapy|sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
12026715|NCT00392288|Drug|Ciclesonide|Ciclesonide MDI 40 µg BID over twelve weeks
12026716|NCT00392288|Drug|Ciclesonide|Ciclesonide MDI 80 µg BID over twelve weeks
12026717|NCT00392288|Drug|Placebo|Placebo MDI over twelve weeks
12026718|NCT00392275|Drug|Ofloxacin 0.3%|
12026719|NCT00392275|Drug|Ciprofloxacin 0.3%|
12026720|NCT00392275|Drug|Levofloxacin 0.5%|
12026721|NCT00392275|Drug|Ofloxacin 400mg|
12026722|NCT00392275|Drug|Ciprofloxacin 400mg|
12026723|NCT00392275|Drug|Levofloxacin 250mg|
12026724|NCT00392262|Drug|valsartan + amlodipine|
12026725|NCT00392249|Behavioral|Supervised Treatment of Schizophrenia by a family member|
12026726|NCT00392236|Device|2-way pager|Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking.
12026727|NCT00392236|Behavioral|Treatment as usual|Participants will receive treatment as usual.
12026728|NCT00392223|Drug|Azithromycin microspheres|Azithromycin microspheres, powder for oral suspension, 2 g a week, in unique administration PO, repeated weekly for 8 weeks and minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
12026729|NCT00392223|Drug|minocycline-placebo capsules|minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
12026730|NCT00392223|Drug|Azithromycin microspheres-placebo|Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.
12026731|NCT00392223|Drug|Minocycline capsules,|Capsules, PO, 100 mg daily for 8 weeks.
12026732|NCT00392210|Genetic|Voiding Trial|Post-void residual and uroflow study will be done twice
12026738|NCT00392145|Drug|Rapid intravenous rehydration (RIVR)|A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
12026739|NCT00392119|Device|MR-guided Laser Interstitial Thermal Therapy System|
12026740|NCT00392106|Drug|propafenone|Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
12026741|NCT00392106|Drug|flecainide|Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
12026742|NCT00392106|Drug|dofetilide|Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
12026743|NCT00392106|Drug|sotolol|Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
12026744|NCT00392106|Device|Pulmonary vein ablation|Electrical isolation of pulmonary vein with high-intensity focused ultrasound
12026745|NCT00392106|Drug|Amiodarone|Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
12026746|NCT00392093|Drug|Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d|
12026747|NCT00392080|Drug|CJ-023,423|75 mg BID
12026748|NCT00392080|Drug|placebo|placebo
12026749|NCT00392080|Drug|naproxen|naproxen
12026750|NCT00392067|Drug|Calcipotriol and LEO80122 (LEO19123 cream)|
12026751|NCT00392054|Procedure|Pulmonary Vein Isolation performed by Catheter Ablation|Ablation will be done to achieve entrance block into all pulmonary veins.
12026752|NCT00392054|Drug|Conventional Antiarrhythmic Drug Therapy|Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF
12026753|NCT00392041|Drug|Eszopiclone|3mg qpm for 12 weeks
12026754|NCT00392041|Drug|placebo|1 pill qpm for 12 weeks
12026755|NCT00392028|Drug|ertapenem|
12026756|NCT00392015|Biological|NMRC-M3V-Ad-PfCA|Malaria Vaccine
12026757|NCT00392015|Biological|NMRC-MV-Ad-PfC, NMRC-MV-Ad-PfA|Malaria Vaccines
12026758|NCT00392002|Drug|Esomeprazole|
12026759|NCT00391989|Drug|Dasatinib|
12026760|NCT00391976|Drug|Tobramycin solution for inhalation 300 mg|Tobramycin solution for inhalation was supplied in 5 mL liquid-filled low-density polyethylene ampoules containing 300 mg tobramycin. Patients used a nebulizer to inhale the contents of the ampoules.
12026761|NCT00391963|Device|Bispectral index, Entropy|
12026762|NCT00391950|Drug|Zoledronic acid|
12026763|NCT00391937|Device|Articular Surface Replacement (ASR) hip prosthesis|a DePuy ASR™ primary resurfacing femoral and acetabular component (DePuy International Ltd, Leeds, UK). The cement that will be used is one dose of DePuy SmartSet® GHV 40 gram, a high-viscosity cement with gentamycin (DePuy CMW, Blackpool, UK). Instrumentation includes standard ASR™ instruments and Ci™ Software for DePuy ASR™ System1.0.
12026764|NCT00391924|Drug|Dehydroepiandrosterone|
12026765|NCT00391911|Drug|N-Acetylcysteine|Patients are assigned to either N-Acetylcysteine or placebo. Dose is weight based Placebo is normal saline or D5W
12026766|NCT00391911|Other|N-Acetylcystine and Non CRRT|Patients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label as would be impossible to blind
12026767|NCT00391911|Other|Placebo and CRRT|Patients are assigned to Placebo and CRRT. The N-Acetylcysteine/Placebo is blinded to everyone except pharmacy. The CRRT is open label
12026768|NCT00391911|Other|Placebo and Non CRRT|Patients are assigned to Placebo and non-CRRT. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT/non CRRT is open label as would be impossible to blind
12026769|NCT00391898|Drug|Levodopa/carbidopa/entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
12026770|NCT00391898|Drug|Levodopa/carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
12026771|NCT00391885|Device|Closed-loop anesthesia system|
12026772|NCT00391872|Drug|Ticagrelor|Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
12026773|NCT00391872|Drug|Clopidogrel|Clopidogrel 75 mg once daily dose (ODD)
12026774|NCT00391859|Procedure|Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)|See Detailed Description.
12026775|NCT00391846|Drug|Captopril|
12026776|NCT00391846|Drug|Enalapril|
12026777|NCT00391846|Drug|Lisinopril|
12026778|NCT00391846|Drug|Ramipril|
12026779|NCT00391846|Drug|Trandolapril|
12026780|NCT00391846|Drug|Bisoprolol|
12026781|NCT00391846|Drug|Carvedilol|
12026782|NCT00391846|Drug|Metoprolol succinate|
12026783|NCT00391846|Drug|Candesartan|
12026784|NCT00391846|Drug|Valsartan|
12026785|NCT00391846|Drug|Eplerenone|
12026786|NCT00391846|Drug|Spironolactone|
12026787|NCT00391846|Drug|Diuretics|
12026788|NCT00391846|Drug|HF treatment according to Swedish guidelines|
12026789|NCT00391846|Procedure|Blood samples|
12026790|NCT00391846|Procedure|The Kansas City Cardiomyopathy Questionnaire (KCCQ)|
12026791|NCT00391833|Drug|Panax Ginseng|
12026792|NCT00391820|Drug|TD-5108|
12026793|NCT00391807|Drug|Norethindrone acetate/ethinyl estradiol|one tablet per day
12026794|NCT00391794|Behavioral|Early Stage Memory Loss Support Group|8 week support group led by trained facilitators
12026795|NCT00391794|Behavioral|Educational Seminar|4 hour education session led by trained facilitators
12026796|NCT00391781|Procedure|Temperature of contrast medium|
12026838|NCT00391430|Drug|Sertraline|Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
12026839|NCT00391430|Behavioral|Cognitive behavioral therapy (CBT)|CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
12026840|NCT00391417|Drug|estradiol gel|
12026841|NCT00391404|Drug|Alendronate|Alendronate 70 mg weekly (oral)
12026842|NCT00391404|Drug|Placebo|Placebo
12026843|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine|Vaccine (infant dose)
12026844|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine|Vaccine (children dose)
12026797|NCT00391768|Drug|oseltamivir (Tamiflu®)|Oseltamivir is supplied as a white powder blend for constitution to a suspension. It is supplied in 100 ml amber glass bottles with 30 grams of powder for oral suspension, a plastic adapter, a plastic oral dispenser and a plastic measuring cup. Initially subjects in Cohort I received oseltamivir 30 mg orally twice daily for 5 days. The DSMB recommended on 05-Aug-2009 that weight based dosing of oseltamivir for subjects subsequently enrolled in Cohort I. Based on pharmacokinetic data available as of that date, the initial weight-based dose to be evaluated for Cohort I is 3.5 mg/kg twice a day. Cohort II and Cohort III will receive oseltamivir at 3.0 mg/kg/dose orally twice daily for 5 days. Cohorts IV and V will receive 3.0 mg/kg/dose orally twice daily for 5 days, this dose may be adjusted.
12026798|NCT00391755|Drug|ramelteon|"ramelteon 8mg po qhs with sleep and headache diary
~placebo 1 po qhs with sleep and headache diary"
12026799|NCT00391742|Behavioral|Brief intervention|
12026800|NCT00391729|Drug|ABT-089|Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks
12026801|NCT00391729|Drug|Placebo|Subjects will take placebo QD, BID for 4-6 weeks
12026802|NCT00391716|Drug|Gabapentin 900mg|900 mg gabapentin daily for 12 weeks
12026803|NCT00391716|Behavioral|behavioral counseling|The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
12026804|NCT00391716|Drug|placebo|lactose capsule compounded to mimic gabapentin capsules
12026805|NCT00391716|Drug|gabapentin 1800mg|1800 mg gabapentin daily for 12 weeks
12026806|NCT00391703|Behavioral|Electrostimulation programme: using a cycloergometer|Quadriceps electrostimulation programme performed prior to an endurance retraining program using a cycloergometer, for 6 weeks, 60 to 90 minutes by session, 5 to 6 sessions per week
12026807|NCT00391703|Behavioral|Usual sport activity|Usual sport activity performed prior to an endurance retraining program using a cycloergometer
12026808|NCT00391690|Drug|Zoledronic acid|In case of bone metastases: Zoledronic acid every 4 weeks for 3 months.
12026809|NCT00391677|Behavioral|Social skills training with attention shaping procedures|Social skills training with attention shaping procedures includes behavioral procedures to increase the frequency, intensity, and duration of attentive behaviors and to reduce the frequency of inattentive behaviors.
12026810|NCT00391677|Behavioral|Social skills training without attention shaping|Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.
12026811|NCT00391664|Behavioral|Psychosocial|
12026812|NCT00391651|Drug|Nitrofurantoin 100mg twice daily x 5 days|Nitrofurantoin 100mg twice daily x 5 days
12026813|NCT00391651|Drug|TMP/SMX DS twice daily x 3 days|TMP/SMX DS twice daily x 3 days
12026814|NCT00391638|Drug|TRUVADA (EMTRICITABINE + TENOFOVIR DF)|Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
12026815|NCT00391638|Biological|PEGASYS 180μg (Interféron pégylé alpha -2a)|Pegasys ® injection 180μg Dosage: A subcutaneous injection per week
12026816|NCT00391625|Drug|GA-GCB|15-60 U/kg every other week via intravenous infusion
12026817|NCT00391612|Device|Exhale® Drug-Eluting Stent|Bronchoscopic procedure in which up to six Exhale Drug-Eluting Stents are placed in the lungs; total procedure time is 1 to 2 hours
12026818|NCT00391612|Device|Sham control|5-10 minute bronchoscopic procedure in which the lungs are examined and a bronchial lavage is performed; the bronchoscope is then retracted to a point above the carina and below the vocal folds for the remained of the time; total procedure time is about 1-2 hours
12026819|NCT00391599|Procedure|enema|
12026820|NCT00391586|Drug|Erlotinib|"Erlotinib will be administered for at least 2 cycles (6 weeks) and for a maximum of 8 months.
~Upon progression or intolerance to erlotinib, standard of care platinum-based chemotherapy (per the choice of the treating physician) is administered every 3 weeks. Physicians can adjust dose, schedule, or supportive care to the benefit of the patient"
12026821|NCT00391586|Drug|Platinum-based chemotherapy|Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles
12026822|NCT00391573|Procedure|Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery|
12026823|NCT00391573|Procedure|Nylon sutures for suturing of conjunctival autograft in pterygium surgery|
12026824|NCT00391560|Drug|perifosine|Identical intervention in both arms.
12026825|NCT00391547|Drug|Frio Oral Rinse|
12026826|NCT00391534|Drug|modified release formulation of oxcarbazepine (OXC MR)|Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC MR. Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.
12026827|NCT00391534|Drug|immediate release formulation of oxcarbazepine (OXC IR)|Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC IR (divided in two daily doses). Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.
12026828|NCT00391521|Drug|AS703569|Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
12026829|NCT00391521|Drug|AS703569|Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
12026830|NCT00391521|Drug|AS703569|Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
12026831|NCT00391495|Procedure|Blood drawing|
12026832|NCT00391482|Behavioral|Peer Mentoring Intervention for HCV-Infected IDUs|
12026833|NCT00391469|Other|Rapid infusion of 2 liters of 4oC normal saline|Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
12026834|NCT00391469|Drug|Rapid infusion of cold normal saline|
12026835|NCT00391456|Behavioral|Animal-assisted Therapy|
12026836|NCT00391443|Drug|Bosentan|Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight > 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight < 40 kg)
12026837|NCT00391443|Drug|Placebo|Placebo matching bosentan 62.5 mg tablets and 125 mg tablets
12026845|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)|Vaccine (infant dose)
12026846|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)|Vaccine (children dose)
12026847|NCT00391365|Procedure|Gait analysis|Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras.
12026848|NCT00391352|Drug|IFN-β-1a (Rebif®)|44 mcg Three times a week, subcutaneous injection
12026849|NCT00391339|Drug|Bryophyllum p.|
12026850|NCT00391313|Drug|Chloroquine|
12026851|NCT00391300|Procedure|bioelectric field imaging|
12026852|NCT00391300|Procedure|biopsy|
12026853|NCT00391300|Procedure|histopathologic examination|
12026854|NCT00391274|Drug|pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment
12026855|NCT00391274|Drug|docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment
12026856|NCT00391261|Drug|Metformin|open-label, flexible dosing
12026857|NCT00391248|Drug|Erlotinib|150 mg in a single daily dose, starting Day 1 through Day 22
12026858|NCT00391222|Drug|Olanzapine|Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily
12026859|NCT00391222|Drug|Placebo|Intramuscular injections of placebo every 2 weeks and oral placebo daily
12026860|NCT00391222|Drug|Risperidone Long Acting Injectable (LAI)|Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily
12026861|NCT00391209|Drug|simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals,6 months
12026862|NCT00391209|Drug|intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 6 months
12026863|NCT00391196|Drug|Placebo|Subjects receive placebo plus non-pharmacological weight loss program.
12026864|NCT00391196|Drug|CP-945,598|Subjects receive CP-945,598 plus non-pharmacological weight loss program.
12026865|NCT00391196|Drug|CP-945,598 Treatment B|Subjects receive CP-945,598 plus non-pharmacological weight loss program.
12026866|NCT00391183|Procedure|Biliary stenting|ERCP and stenting
12026867|NCT00391170|Drug|Topical Dexamethasone|dexamethasone 0.01%
12026868|NCT00391170|Other|Placebo|Placebo
12026869|NCT00391157|Drug|Velcade/Dexamethasone|Velcade 1,3 mg/m2 on days 1, 4, 8 and 11
12026870|NCT00391144|Procedure|intravitreal triamcinolone injection of avastin (1.25 mg)|
12026871|NCT00391131|Drug|IgNextGen 16%|IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12
12026872|NCT00391118|Drug|enzastaurin|
12026873|NCT00391118|Drug|carboplatin|
12026874|NCT00391118|Drug|paclitaxel|
12026875|NCT00391118|Drug|placebo|
12026876|NCT00391105|Drug|Remifentanil|
12026877|NCT00391092|Drug|bevacizumab [Avastin]|15mg/kg iv every 3 weeks
12026878|NCT00391092|Drug|Docetaxel|100mg/m2 iv every 3 weeks
12026879|NCT00391092|Drug|Herceptin|8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
12026880|NCT00391079|Drug|Sativex|"Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.
~Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg."
12026881|NCT00391079|Drug|Placebo|Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.
12026882|NCT00391066|Drug|FCR + Lumiliximab|Dose, schedule, and duration specified in the protocol
12026883|NCT00391066|Drug|FCR|Dose, schedule, and duration specified in protocol
12026884|NCT00391053|Biological|High-Dose Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
12026885|NCT00391053|Biological|High-Dose Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
12026886|NCT00391053|Biological|High-Dose Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
12026887|NCT00391053|Biological|Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
12026888|NCT00391040|Behavioral|SGS education|
12026889|NCT00391027|Drug|Insulin Glargine (Lantus®)|Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
12026890|NCT00391027|Drug|Inhaled Human Insulin (Exubera®)|Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
12026891|NCT00391014|Drug|liposomal Amphotericine B|"AML patients in induction chemotherapy treatment will received prophylaxis with nebulized liposomal amphotericin B (24 mg/week). It will be maintained during the intensification chemotherapy and in periods between cycles.
~If patient required ALO-TPH, the prophylaxis should be followed."
12026892|NCT00391001|Drug|Taurine|double-blind, placebo-controlled, adjunctive medication
12026893|NCT00390988|Procedure|blood sampling|
12026894|NCT00390975|Drug|Tegaserod|
12026895|NCT00390949|Behavioral|Peer education among commercial sex workers and clients|
12026896|NCT00390949|Behavioral|Condom distribution and promotion|
12026897|NCT00390949|Procedure|Syndromic treatment of sexually transmitted infections|
12026898|NCT00390949|Procedure|Systemic counselling for STI patients|
12026899|NCT00390936|Drug|Brivanib|Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity
12026900|NCT00390923|Drug|Selegiline + nicotine replacement therapy|Participants will begin selegiline once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
12027038|NCT00390052|Drug|triapine|Given IV and orally
12026901|NCT00390923|Drug|placebo + nicotine replacement therapy|Participants will begin placebo once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
12026902|NCT00390910|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 3 doses
12026903|NCT00390910|Biological|Infanrix hexa|Intramuscular injection, 3 doses
12026904|NCT00390897|Drug|Glivec|
12026905|NCT00390897|Drug|Interferon|
12026906|NCT00390884|Biological|Influenza Virus Vaccine, Fluzone®|0.25 mL, Intramuscular
12026907|NCT00390884|Biological|Influenza Virus Vaccine, Fluzone®|0.25 mL, Intramuscular
12026908|NCT00390871|Drug|Fentanyl/Dexmedetomidine|
12026909|NCT00390871|Drug|Fentanyl/Propofol|
12026910|NCT00390871|Drug|Fentanyl|
12026911|NCT00390858|Drug|Deferasirox|Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or decreasing Liver Iron Concentration (LIC), and serum ferritin. Deferasirox was available as 125 mg, 250 mg and 500 mg tablets.
12026912|NCT00390845|Drug|SB681323|15 milligrams (mg)/day
12026913|NCT00390845|Drug|Placebo|
12026914|NCT00390832|Drug|Erythropoietin|33.333 IU of recombinant human erythropoietin beta are given at 3 time points (immediately, 24 hours and 48 hours after percutaneous coronary intervention) providing a cumulative dose of 100.000 IU
12026915|NCT00390832|Other|Placebo|Patients will receive placebo immediately, 24 hours and 48 hours after percutaneous coronary intervention.
12026916|NCT00390806|Drug|HYCAMTIN, oral capsules|topotecan oral capsules 1.1 mg/m2
12026917|NCT00390806|Radiation|Radiation|Whole brain radiation
12026918|NCT00390793|Drug|Cyclophosphamide|Given IV
12026919|NCT00390793|Drug|Cytarabine|Given IV or IT
12026920|NCT00390793|Drug|Dasatinib|Given PO
12026921|NCT00390793|Drug|Dexamethasone|Given IV or PO
12026922|NCT00390793|Drug|Doxorubicin|Given IV
12026923|NCT00390793|Drug|Methotrexate|Given IV or IT
12026924|NCT00390793|Drug|Prednisone|Given PO
12026925|NCT00390793|Drug|Vincristine|Given IV
12026926|NCT00390780|Drug|miconazole Lauriad|50 mg buccal tablet once a day for 14 days
12026927|NCT00390780|Drug|Clotrimazole|10mg troches administered Five Times a Day for 14 days
12026928|NCT00390767|Biological|MultiGeneAngio|Escalating doses of MultiGeneAngio, one dose per patient administered as one treatment, infused intra-arterially
12026929|NCT00390754|Behavioral|Education for pregnancy planning|Provision of free home pregnancy tests to women at risk for unintended pregnancy
12026930|NCT00390741|Behavioral|Exercise Plus Program|Those assigned to the treatment group were visited by an exercise trainer three times a week for the first two months of the study, two times per week during months three and four, one time per week during months five and six, two times a month during months seven and eight, and one time a month during months nine through twelve. During months seven through twelve of the study the trainer contacted the participant by telephone once each week during the weeks that he or she did not go the participants' home.
12026931|NCT00390728|Drug|Insulin Glargine|
12026932|NCT00390715|Drug|chemotherapy|
12026933|NCT00390702|Device|transcatheter implantation of a VSD occluder (Nitinol coil)|transcatheter implantation, by first performing a arterial-venous loop through the defect
12026934|NCT00390689|Drug|Pramipexole 0.125 mg tablet|
12026935|NCT00390689|Drug|Pramipexole 0.5 mg tablet|
12026936|NCT00390676|Drug|ADH -1 and carboplatin|
12026937|NCT00390676|Drug|ADH -1 and docetaxel|
12026938|NCT00390676|Drug|ADH -1 and capecitabine|
12026939|NCT00390663|Procedure|Nasal Cautery|
12026940|NCT00390650|Drug|Saredutant|
12026941|NCT00390637|Behavioral|High or low Glycemic Index and high or low Protein Diet|
12026942|NCT00390624|Drug|URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)|
12026943|NCT00390624|Drug|MANNITOL|
12026944|NCT00390611|Drug|Sorafenib|
12026945|NCT00390611|Drug|Paclitaxel|Paclitaxel
12026946|NCT00390611|Drug|Carboplatin|Carboplatin
12026947|NCT00390598|Drug|PEG (solution given 4 L)|
12026948|NCT00390598|Drug|senna glycoside 36 mg and PEG (solution given 2 L)|
12026949|NCT00390585|Drug|Iodixanol 320|Iodixanol 320 is used as contrast media while coronary intervention.
12026950|NCT00390585|Drug|Iomeprol 350|Iomeprol 350 is used as contrast media while coronary intervention.
12026951|NCT00390572|Behavioral|Sleep Specialty Consultation|The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers.
12026952|NCT00390559|Drug|nicotine transdermal system|21 mg nicotine transdermal system
12026953|NCT00390559|Drug|Nicotine transdermal system|Placebo nicotine patch
12026954|NCT00390559|Other|Nicotine containing cigarette|Nicotine containing cigarette
12026955|NCT00390559|Other|Placebo cigarette|Non nicotine containing cigarette
12026956|NCT00390546|Drug|Digoxin|
12026957|NCT00390546|Drug|Propranolol|
12026958|NCT00390533|Drug|Saredutant|oral administration (capsules)
12026959|NCT00390533|Drug|Placebo|oral administration (capsules)
12026960|NCT00390520|Drug|Vildagliptin|
12026961|NCT00390507|Procedure|Post-tetanic count frequency|
12026962|NCT00390494|Procedure|Hysterectomy|
12026963|NCT00390494|Procedure|Myomectomy|
12026964|NCT00390494|Procedure|Uterine Fibroid Embolization|
12027039|NCT00390052|Other|pharmacological study|correlative study
12026965|NCT00390481|Procedure|EC-IC Bypass in the COSS study|EC-IC Bypass surgery involves taking an artery from the scalp outside the skull, making a small hole in the skull, and then connecting the scalp artery to a brain artery inside the skull. In this way, the blockage of the carotid artery in the neck is bypassed and more blood can flow to the brain.
12026966|NCT00390468|Drug|Tandutinib|500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle.
12026967|NCT00390455|Drug|Fulvestrant|Given IM
12026968|NCT00390455|Other|Laboratory Biomarker Analysis|Correlative studies
12026969|NCT00390455|Drug|Lapatinib Ditosylate|Given PO
12026970|NCT00390455|Other|Placebo Administration|Given PO
12026971|NCT00390442|Device|continuous positive airway pressure|
12026972|NCT00390429|Drug|docetaxel|Given IV
12026973|NCT00390429|Drug|erlotinib hydrochloride|Given orally
12026974|NCT00390416|Drug|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
12026975|NCT00390403|Drug|R-(-)-gossypol acetic acid|
12026976|NCT00390403|Drug|temozolomide|
12026977|NCT00390403|Genetic|gene expression analysis|
12026978|NCT00390403|Genetic|mutation analysis|
12026979|NCT00390403|Genetic|protein expression analysis|
12026980|NCT00390403|Other|laboratory biomarker analysis|
12026981|NCT00390403|Other|pharmacological study|
12026982|NCT00390403|Procedure|adjuvant therapy|
12026983|NCT00390403|Radiation|radiation therapy|
12026984|NCT00390390|Drug|Lansoprazole|
12026985|NCT00390377|Procedure|Cutting scalp hair|
12026986|NCT00390364|Drug|everolimus|
12026987|NCT00390364|Procedure|antiangiogenesis therapy|
12026988|NCT00390364|Procedure|biopsy|
12026989|NCT00390364|Procedure|diagnostic procedure|
12026990|NCT00390364|Procedure|gene expression analysis|
12026991|NCT00390364|Procedure|immunohistochemistry staining method|
12026992|NCT00390364|Procedure|laboratory biomarker analysis|
12026993|NCT00390364|Procedure|mutation analysis|
12026994|NCT00390364|Procedure|protein tyrosine kinase inhibitor therapy|
12026995|NCT00390364|Procedure|reverse transcriptase-polymerase chain reaction|
12026996|NCT00390351|Device|optical coherence tomography|
12026997|NCT00390338|Biological|polarized dendritic cells|
12026998|NCT00390338|Biological|non-polarized dendritic cells|
12026999|NCT00390325|Drug|Sorafenib Tosylate|Given PO
12027000|NCT00390312|Drug|Intranasal Placebo|Intranasal placebo
12027001|NCT00390312|Drug|Intranasal Morphine 15 mg|Intranasal Morphine 15 mg
12027002|NCT00390312|Drug|Immediate Release Oral Morphine 60 mg|Immediate Release Oral Morphine 60 mg
12027003|NCT00390312|Drug|Intravenous morphine|Intravenous morphine 7.5 mg
12027004|NCT00390312|Drug|Intranasal morphine 7.5 mg|Intranasal morphine 7.5 mg
12027005|NCT00390312|Drug|Oral placebo|Oral placebo
12027006|NCT00390312|Drug|Intravenous placebo|Intravenous placebo
12027007|NCT00390299|Biological|Carcinoembryonic Antigen-Expressing Measles Virus|Given via injection into resection cavity or around tumor bed and/or IT
12027008|NCT00390299|Other|Laboratory Biomarker Analysis|Correlative studies
12027009|NCT00390299|Procedure|Therapeutic Conventional Surgery|Undergo en bloc resection
12027010|NCT00390273|Drug|Metformin|
12027011|NCT00390260|Drug|MK0966 / Duration of Treatment: 1 Days|
12027012|NCT00390260|Drug|Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days|
12027013|NCT00390260|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 1 Days|
12027014|NCT00390247|Drug|thalidomide|
12027015|NCT00390234|Drug|ziv-aflibercept|Given IV
12027016|NCT00390221|Biological|BIIB019 (Daclizumab High Yield Process)|SC injection
12027017|NCT00390221|Drug|Placebo|Placebo SC injection
12027018|NCT00390208|Drug|ranibizumab, dexamethasone and verteporfin|One 500 microgram dose (0.05cc) intravitreal dexamethasone (10 mg/ml vial) in combination with Visudyne Photodynamic Therapy and 0.5 mg intravitreal Ranibizumab injection on the same day.
12027019|NCT00390208|Drug|Ranibizumab|One 0.5 mg intravitreal Ranibizumab injection
12027020|NCT00390195|Drug|RAD001 (everolimus)|Arm 1: 2.5, 5, 7.5 or 10 mg of RAD001 daily
12027021|NCT00390195|Drug|RAD001 (everolimus)|Arm 2: 20, 30, 50 or 70 mg of RAD001 daily
12027022|NCT00390182|Drug|Gemcitabine|"Gemcitabine will be given at 1250 mg per meter squared over 2 hours days 1 and 8 of a 21 day cycle for a total of 4 cycles.
~Radiation:External Radiation Therapy The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy.
~**Radiation is the experimental part of the study."
12027023|NCT00390169|Behavioral|Mindfulness Meditation-Based Stress Reduction|
12027024|NCT00390169|Behavioral|Supportive-Expressive Group Therapy|
12027025|NCT00390156|Biological|bevacizumab|5 mg/kg
12027026|NCT00390156|Drug|cyclophosphamide|Current dose 50 mg
12027027|NCT00390156|Drug|imatinib|Current dose 400 mg
12027028|NCT00390143|Biological|Meningococcal vaccine 134612|One intramuscular dose during the primary study
12027029|NCT00390143|Biological|Mencevax™ ACWY|One subcutaneous dose during the primary study
12027030|NCT00390130|Drug|Pentacel (DPTaP+Hib)|
12027031|NCT00390130|Drug|Prevnar (conjugated pneumococcal vaccine)|
12027032|NCT00390117|Drug|CDKI AT7519|AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.
12027033|NCT00390117|Other|laboratory biomarker analysis|Pharmacokinetic bioanalysis of the AT7519 plasma concentration data will be performed by BioDynamics Northhampton, U.K. The pharmacokinetic parameters for AT7519 will be determined by Astex Therapeutics as data permits.
12027034|NCT00390091|Drug|abetimus sodium (LJP 394)|
12027035|NCT00390078|Biological|MVA-mBN32|3 immunizations: 1x 10E8_TCID50 MVA-mBN32
12027036|NCT00390078|Biological|IMVAMUNE|3 immunizations: 1x 10E8_TCID50 IMVAMUNE
12027037|NCT00390065|Drug|Nitric Oxide|Early low dose (5ppm) NO inhalation Placebo
12027040|NCT00390052|Procedure|laboratory biomarker analysis|Correlative study
12027041|NCT00390039|Drug|Intranasal Morphine|MNS075 7.5mg q1h PRN
12027042|NCT00390039|Drug|Placebo|IN Placebo q1h PRN
12027043|NCT00390039|Drug|IV morphine|IV morphine 7.5mg q3h PRN
12027044|NCT00390039|Drug|Placebo|IV Placebo q3h PRN
12027045|NCT00390039|Drug|Intranasal morphine|MNS075 15mg q3h PRN
12027046|NCT00390039|Drug|Placebo|IN Placebo q3h PRN
12027047|NCT00390026|Drug|Bevacizumab (Avastin)|
12027048|NCT00390026|Drug|Verteporfin photodynamic therapy (PDT)|
12027049|NCT00390013|Drug|Gabapentin|"300 mg. capsules
~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
~day 1 you will take 1 capsule for the day
~day 2 you will take 1 capsule 2 times for that day
~days 3-6 you will take 1 capsule 3 times for those days
~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
~days 13-14 you will take 2 capsules 3 times each day
~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
~at completion of study treatment you will titrate off study drug over a weeks time."
12027050|NCT00390013|Drug|Placebo oral capsule|"Placebo capsules
~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
~day 1 you will take 1 capsule for the day
~day 2 you will take 1 capsule 2 times for that day
~days 3-6 you will take 1 capsule 3 times for those days
~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
~days 13-14 you will take 2 capsules 3 times each day
~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
~at completion of study treatment you will titrate off study drug over a weeks time."
12027051|NCT00390000|Drug|vatalanib|Given orally
12027052|NCT00390000|Drug|pemetrexed disodium|Given IV
12027053|NCT00390000|Other|pharmacological study|Correlative study
12027054|NCT00390000|Procedure|ultrasound imaging|Correlative study
12027055|NCT00389987|Drug|MK0826, /Duration of Treatment : 8 Weeks|
12027056|NCT00389987|Drug|Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks|
12027057|NCT00389974|Drug|sunitinib malate|Given PO
12027058|NCT00389948|Drug|Lanzoprazole|
12027059|NCT00389935|Drug|Thalidomide|Thalidomide 50 - 200 mg once at nightime
12027060|NCT00389922|Drug|lapatinib ditosylate|Given orally for 28 days per dose level (Dose level 1: 250mg; Dose level 2: 500mg; Dose level 3: 1000mg; Dose level 4: 1250mg; Dose level 5: 1500mg; Dose level 6: 1500mg)
12027061|NCT00389922|Drug|vinorelbine ditartrate|Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 20mg/m2; Dose level 4: 20mg/m2; Dose level 5: 20mg/m2; Dose level 6: 25mg/m2)
12027062|NCT00389922|Genetic|comparative genomic hybridization|Molecular correlative study
12027063|NCT00389922|Genetic|cytogenetic analysis|Molecular correlative study
12027064|NCT00389922|Genetic|gene expression analysis|Molecular correlative study
12027065|NCT00389922|Genetic|mutation analysis|Molecular correlative study
12027066|NCT00389922|Genetic|polymerase chain reaction|Molecular correlative study
12027067|NCT00389922|Genetic|polymorphism analysis|Molecular correlative study
12027068|NCT00389922|Genetic|proteomic profiling|Molecular correlative study
12027069|NCT00389922|Genetic|reverse transcriptase-polymerase chain reaction|Molecular correlative study
12027070|NCT00389922|Other|immunohistochemistry staining method|Molecular correlative study
12027071|NCT00389922|Other|laboratory biomarker analysis|Molecular correlative study
12027072|NCT00389922|Drug|lapatinib ditosylate|Given orally on Days 2-5, 9-12 and 16-25 per dose level (Dose level 1: 1250mg; Dose level 2: 1500mg; Dose level 3: 1500mg; Dose level 4: 1700mg)
12027073|NCT00389922|Drug|Vinorelbine ditartrate|Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 25mg/m2; Dose level 4: 25mg/m2)
12027074|NCT00389909|Drug|Doxapram|"Dosing comparison between fixed scheduled and sex related dosage.
~Dosing related to weight only versus chart taking into account weight, age and gender."
12027075|NCT00389896|Drug|MK0733 / Duration of Treatment: 18 Weeks|
12027076|NCT00389896|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks|
12027077|NCT00389883|Drug|Comparison of two anesthetics protocol|Comparison of two anesthetics protocol
12027078|NCT00389870|Biological|panitumumab|
12027079|NCT00389870|Drug|cyclosporine|
12027080|NCT00389870|Drug|irinotecan hydrochloride|
12027081|NCT00389857|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (infant/children dose)
12027082|NCT00389857|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (infant/children dose)
12027083|NCT00389844|Behavioral|Exercise Trainer component of the Exercise Plus Program|With the exception of the routine care group, the exercise trainers visited each of the participant in their homes twice a week for two months, once a week for four months, and once a month for six months.
12027084|NCT00389844|Behavioral|Plus component (motivation) of the Exercise Plus Program|Motivation only
12027085|NCT00389844|Behavioral|Exercise Plus Program (exercise + motivation)|Exercise plus motivation
12027086|NCT00389831|Drug|Rotigotine Nasal Spray|Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
12027087|NCT00389831|Other|Placebo Nasal Spray|Daily single dose of placebo delivered as single puff of nasal spray solution
12027088|NCT00389818|Biological|filgrastim|Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
12027089|NCT00389818|Biological|pegfilgrastim|GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
12027090|NCT00389818|Biological|rituximab|375 mg/m2 IV Day 1 of each cycle
12027091|NCT00389818|Biological|sargramostim|GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
12027092|NCT00389818|Drug|cyclophosphamide|750 mg/m2 IV Day 1 of each cycle
12027093|NCT00389818|Drug|pegylated liposomal doxorubicin hydrochloride|40 mg/m2 IV Day 1 of each cycle
12027094|NCT00389818|Drug|prednisone|100 mg PO Days 1-5 of each cycle
12027095|NCT00389818|Drug|vincristine sulfate|1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle
12027096|NCT00389818|Other|immunohistochemistry staining method|tissue specimen collected at baseline
12027097|NCT00389818|Other|laboratory biomarker analysis|tissue specimen collected at baseline
12027098|NCT00389805|Drug|bortezomib|
12027099|NCT00389805|Drug|pemetrexed disodium|
12027100|NCT00389805|Genetic|gene expression analysis|
12027101|NCT00389805|Genetic|mutation analysis|
12027102|NCT00389805|Genetic|protein expression analysis|
12027103|NCT00389805|Genetic|reverse transcriptase-polymerase chain reaction|
12027104|NCT00389805|Other|flow cytometry|
12027105|NCT00389805|Other|immunoenzyme technique|
12027106|NCT00389805|Other|immunohistochemistry staining method|
12027107|NCT00389792|Drug|ATI-2042|no intervention
12027108|NCT00389792|Drug|ATI-2042 200 mg|To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.
12027109|NCT00389779|Drug|Darusentan|Darusentan capsules administered orally once daily
12027110|NCT00389779|Drug|Guanfacine|Guanfacine capsules administered orally once daily
12027111|NCT00389779|Drug|Darusentan Placebo|Placebo to match darusentan administered orally once daily
12027112|NCT00389766|Drug|iodine I 131 metaiodobenzylguanidine|
12027113|NCT00389766|Drug|topotecan hydrochloride|
12027114|NCT00389766|Procedure|chemotherapy|
12027115|NCT00389766|Procedure|peripheral blood stem cell transplantation|
12027116|NCT00389766|Procedure|radioisotope therapy|
12027117|NCT00389766|Procedure|radionuclide imaging|
12027118|NCT00389766|Procedure|radiosensitization|
12027119|NCT00389766|Procedure|total-body irradiation|
12027120|NCT00389753|Drug|Application of Aruba Aloë formula F-BC-096 or control|
12027121|NCT00389740|Drug|MK0217, /Duration of Treatment : 12 Months|
12027122|NCT00389740|Drug|Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months|
12027123|NCT00389727|Drug|Radiotherapy|Radiotherapy
12027124|NCT00389714|Device|dental restoration|
12027125|NCT00389701|Drug|bortezomib|
12027126|NCT00389701|Drug|dexamethasone|
12027127|NCT00389688|Drug|cisplatin|
12027128|NCT00389688|Drug|pemetrexed disodium|
12027129|NCT00389688|Procedure|adjuvant therapy|
12027130|NCT00389688|Procedure|conventional surgery|
12027131|NCT00389688|Procedure|neoadjuvant therapy|
12027132|NCT00389675|Drug|Darusentan|Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
12027133|NCT00389675|Drug|Guanfacine|Guanfacine 1 mg capsules administered orally once daily
12027134|NCT00389662|Device|"Wearing the Nike Free shoe"|
12027135|NCT00389649|Device|heart rate setting|
12027136|NCT00389636|Device|TheraGauze|TheraGauze
12027137|NCT00389636|Drug|Regranex|Regranex + TheraGauze
12027138|NCT00389610|Biological|allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine|Given subcutaneously
12027139|NCT00389597|Device|Cervical Artificial Disc|Cervical artificial disc mechanical device
12027140|NCT00389584|Drug|irinotecan hydrochloride|
12027141|NCT00389584|Procedure|cognitive assessment|
12027142|NCT00389584|Procedure|management of therapy complications|
12027143|NCT00389584|Radiation|radiation therapy|
12027144|NCT00389558|Procedure|disinfection efficacy using Biseptine|Detersion and antiseptic application when changing catheter dressing
12027145|NCT00389558|Procedure|disinfection efficacy using Amukin|Detersion and antiseptic application when changing catheter dressing
12027146|NCT00389545|Procedure|Intracoronary infusion of autologous bone-marrow derived stem cells|
12027147|NCT00389532|Biological|Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)|Influenza vaccine
12027148|NCT00389532|Biological|Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)|Influenza vaccine
12027149|NCT00389519|Drug|ramipril|once a day oral ramipril capsules given for 4 weeks
12027150|NCT00389519|Drug|placebo|once a day oral placebo capsule for 4 weeks
12027151|NCT00389506|Biological|LMB-2 immunotoxin|
12027152|NCT00389506|Drug|cyclophosphamide|
12027153|NCT00389506|Drug|fludarabine phosphate|
12027154|NCT00389506|Other|pharmacological study|
12027155|NCT00389493|Drug|Risperidone|Dosage of 0.5 mg to 4.0 mg per day as tolerated
12027156|NCT00389493|Behavioral|Exposure/ritual prevention therapy (EX/RP)|EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
12027157|NCT00389493|Drug|Placebo|Placebo capsules will be identical in appearance to those of risperidone.
12027158|NCT00389480|Drug|AR-67 (formerly DB-67)|infusion daily x 5 days, every 21 days
12027159|NCT00389467|Device|Merci Retriever and Penumbra System|"The MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Retriever consists of a flexible, nickel titanium (nitinol) wire with a helical-shaped distal tip. The helical distal tip is covered with a platinum radiopaque coil, which facilitates fluoroscopic visualization. The body of the MERCI Retriever is covered with a hydrophilic coating that helps facilitate device placement. The MERCI Retriever is available in 6 configurations (Merci Retrievers X6, L5, L4, L6, V series, DAC).
~The Penumbra System uses a reperfusion catheter in parallel with a separator component and an aspiration source to achieve separation of the thrombus and subsequent aspiration of the occlusion from the vessel. The system is available in different sizes according to the target vessels (041 Reperfusion Catheter/Separator pair for use in vessels larger than 3mm, notably the ICA and M1; 032 Reperfusion Catheter/Separator pair for use in vessels 2mm - 3mm, notably the M2)."
12027160|NCT00389441|Drug|AG-013736|AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity
12027161|NCT00389428|Drug|CPX-351 (Cytarabine:Daunorubicin) Liposome Injection|
12027162|NCT00389415|Drug|Vildagliptin|
12027163|NCT00389402|Drug|saquinavir/ritonavir|
12027164|NCT00389402|Drug|atazanavir/ritonavir|
12027165|NCT00389389|Drug|AZD4877|intravenous infusion
12027166|NCT00389376|Drug|Placebo|Placebo
12027167|NCT00389376|Drug|Silymarin|140 mg every 8 hours
12027168|NCT00389376|Drug|Silymarin|280 mg single dose
12027169|NCT00389376|Drug|Silymarin|280 mg single dose + every 8 hours
12027170|NCT00389376|Drug|Silymarin|560 mg single dose + every 8 hours
12027171|NCT00389376|Drug|Silymarin|560 mg single dose + every 8 hours
12027172|NCT00389376|Drug|Silymarin|280 mg every 8 hours
12027173|NCT00389376|Drug|Silymarin|700 mg single dose + every 8 hours
12027174|NCT00389363|Drug|ALK HDM tablet|
12027175|NCT00389350|Drug|Extract of Green and Black Tea|
12027176|NCT00389324|Biological|Immune Globulin Intravenous (Human)|This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months.
12027177|NCT00389311|Drug|Normosol-R|
12027178|NCT00389311|Drug|Nonoxynol-9|
12027179|NCT00389311|Procedure|Gastrointestinal instrumentation|
12027180|NCT00389298|Drug|VCH-759 (BCH-27759)|
12027181|NCT00389285|Drug|rIL-21 only|Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
12027182|NCT00389285|Drug|rIL-21 + sorafenib|Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)
12027183|NCT00389272|Drug|Ibuprofen, acetaminophen|
12027184|NCT00389259|Drug|Placebo|IV placebo q4h
12027185|NCT00389246|Behavioral|Consultation without genetic information|
12027186|NCT00389246|Behavioral|Consultation with genetic information|
12027187|NCT00389233|Drug|Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate|"1 pack will consist of 2L NRL 994 - 4 (2 x PEG + E/P + 2 x Vitamin C/C) sachets for the 2L of 2 sachets (1 x P plus 1 x C) will be dissolved in 1L of water. Each litre will be drunk within 1 hour followed by at least 500ml of any additional clear fluid."
12027188|NCT00389233|Drug|Macrogol3350 Na sulphate Na bicarbonate NaCl KCl|"1 pack will consist of 4L PEG + E - contains 4 sachets for the 4L of PEG + E/P/E. Each sachet will be dissolved in 1L of water. Each litre will be drunk within 1 hour."
12027189|NCT00389220|Device|Coronary stent placement|Coronary stent placement
12027190|NCT00389207|Drug|nevirapine bid|nevirapine twice daily
12027191|NCT00389207|Drug|nevirapine qd|nevirapine once daily
12027192|NCT00389207|Drug|atazanavir|atazanavir once daily
12027193|NCT00389194|Drug|continuing AZT+3TC or switching AZT+3TC to TDF+ FTC|
12027194|NCT00389181|Procedure|Interventional therapy|All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. A patient randomized to interventional therapy is expected to begin interventional therapy within 3 months following randomization. Interventional therapy consists of endovascular attempts at occlusion of the nidus and feeding vessels, coiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and radiosurgery, these alone or in various combinations and timings.
12027195|NCT00389181|Other|Medical management|Patients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. One important consideration in the medical management of patients in this trial is stroke risk factor reduction.
12027196|NCT00389168|Drug|Irbesartan|Titrated to 300 mg od, 48 weeks.
12027197|NCT00389168|Drug|Atenolol|Titrated to 100 mg od, 48 weeks.
12027198|NCT00389155|Drug|Vinflunine|solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
12027199|NCT00389155|Drug|Gemcitabine|solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
12027200|NCT00389155|Other|Placebo|
12027201|NCT00389129|Drug|acetylsalicylic acid|
12027202|NCT00389116|Drug|gastrograffin|ingestion
12027203|NCT00389116|Drug|water|oral water ingestion
12027204|NCT00389103|Biological|MVA (smallpox vaccine)|0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
12027205|NCT00389090|Drug|Temozolomide and O6-Benzylguanine|O6BG + Temozolomide
12027206|NCT00389077|Drug|Perifosine|Perifosine 50 mg tablets
12027207|NCT00389064|Drug|Quetiapine XR|Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.
12027208|NCT00389064|Drug|Placebo|Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.
12027209|NCT00389051|Drug|bendamustine hydrochloride|1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
12027210|NCT00389038|Behavioral|Coping Skills Training|Behavioral Treatment 1 (coping skills training)--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.
12027211|NCT00389038|Behavioral|Headache Education|Behavioral Treatment 2 (headache education)
12027212|NCT00389038|Drug|Amitriptyline|Amitriptyline: up to 1 mg/kg capsule taken once daily at bedtime. Taken up to Week 20. After Week 20 medications and doses may change with standard care.
12027213|NCT00389025|Drug|Olopatadine (generic name)|
12027214|NCT00389012|Procedure|exercise therapy|
12027215|NCT00389012|Procedure|walking rehabilitation|
12027216|NCT00388999|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12027391|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
12027217|NCT00388999|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12027218|NCT00388999|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
12027219|NCT00388986|Drug|GK Activator (2)|100mg po bid
12027220|NCT00388986|Drug|Glyburide|10-20mg po daily
12027221|NCT00388973|Drug|Quetiapine|
12027222|NCT00388960|Drug|Amrubicin|"Amrubicin 45mg/m<2> IV days 1, 2 3 of each 21-day cycle until disease progression.
~Amrubicin 40mg/m<2> IV days 1, 2, 3 plus cisplatin 60mg/m<2> day 1 of each 21-day cycle until disease progression."
12027223|NCT00388960|Drug|Cisplatin|"Amrubicin 40mg/m<2> IV days 1, 2, 3 plus Cisplatin 60mg/m<2> day 1 of each 21-day cycle until disease progression.
~Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression."
12027224|NCT00388960|Drug|Etoposide|Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
12027225|NCT00388947|Device|AMS Prolapse Product|AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family
12027226|NCT00388934|Device|Drug eluting stent|percutaneous intervention with implantation of drug eluting coronary stent
12027227|NCT00388921|Drug|Vitamin A|
12027228|NCT00388908|Behavioral|Reminders and opinion leader generated guidelines +/- leaflets and counselling|
12027229|NCT00388908|Other|Usual Care|
12027230|NCT00388895|Drug|chemotherapy|
12027231|NCT00388895|Drug|Glivec|
12027232|NCT00388882|Drug|tiotropium|
12027233|NCT00388882|Drug|ipratropium bromide / albuterol|
12027234|NCT00388856|Drug|Vitamin C 1000mg and E 400IU|
12027235|NCT00388830|Procedure|Ultrasound|
12027236|NCT00388817|Behavioral|Pharmacist intervention|
12027237|NCT00388804|Procedure|Radiation Therapy|Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between.
12027238|NCT00388804|Drug|Bicalutamide|50 mg By Mouth (PO) Daily
12027239|NCT00388804|Drug|Leuprolide|22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month
12027240|NCT00388804|Drug|Goserelin|10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month
12027241|NCT00388804|Drug|Flutamide|250 mg by mouth three times daily on first 21-30 Days. May be used instead of Bicalutamide.
12027242|NCT00388804|Behavioral|Questionnaire|Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.
12027243|NCT00388791|Drug|Systane Free|
12027244|NCT00388778|Drug|Doxycycline|
12027245|NCT00388752|Procedure|Acupuncture|
12027246|NCT00388739|Drug|Intervention: Budesonide|Patients 1-5 years of age who are randomly assigned to the treatment arm will be given a one month supply as well as a prescription (for a 6 month supply) for Pulmicort respules (children with mild persistent disease will receive 0.25 mg bid whereas children with moderate or severe persistent disease will receive 0.5 mg bid).
12027247|NCT00388739|Drug|Usual care: albuterol + systemic steroids|All children (control and treatment arm) will be given a burst dose of steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day) at discharge from the ED. All children 1-5 years of age will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor.
12027248|NCT00388726|Drug|E7389|1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
12027249|NCT00388726|Drug|Physician's Choice|Treatment of the Physician's Choice defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy, administered according to local practice, if applicable.
12027250|NCT00388713|Procedure|carotid intima-media thickening ultrasound|
12027251|NCT00388700|Drug|GM-CT-01|On Day 1 and 2 of each cycle, GM-CT-01 280 mg/m2 administered IV over 30 minutes with 5-FU (400 mg/m2), followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) with 5-FU (600 mg/m2 .)
12027252|NCT00388700|Drug|5-Fluorouracil, Leukovorin, bevacizumab|On Day 1 and 2 of each cycle, LV (200 mg/m2) will be administered IV over 2 hours, followed by 5-FU 400 mg/m2 in solution with GM-CT-01 280 mg/m2 administered over 30 minutes, followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) and 5-FU (600 mg/m2 ). on Day 3 Avastin® (5 mg/kg)will be given IV over 30 to 90 minutes per the package insert.
12027253|NCT00388687|Drug|18F Fluoroazomycin Arabinoside (FAZA)|
12027254|NCT00388674|Drug|entecavir|Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
12027255|NCT00388674|Drug|Other anti-HBV medication|Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
12027256|NCT00388661|Drug|Melatonin tablet 3 mg once daily|Melatonin tablet 3 mg once daily
12027257|NCT00388661|Drug|Placebo comparator|Placebo comparator
12027258|NCT00388648|Drug|mixture of amino and keto acids|
12027259|NCT00388635|Drug|Velcade|Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)
12027260|NCT00388635|Drug|Melphalan|Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II
12027261|NCT00388635|Drug|Prednisone|Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)
12027262|NCT00388622|Behavioral|Pharmacist intervention|
12027263|NCT00388609|Drug|BMS-646256|Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
12027264|NCT00388609|Drug|Placebo|Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
12027265|NCT00388596|Drug|SB-751689|
12027266|NCT00388583|Biological|Split, Inactivated, Trivalent Influenza Vaccine|0.1 mL, Intradermal
12027267|NCT00388583|Biological|Split, Inactivated, Trivalent Influenza Vaccine|0.5 mL, Intramuscular
12027268|NCT00388570|Device|The Aerocrine NIOX MINO® Airway Inflammation Monitor|
12027269|NCT00388557|Drug|vinflunine + ketaconazole|vinflunine solution for injection, ketaconazole tablets, vinflunine IV, ketaconazole oral, vinflunine 80 to 320mg/m2 + ketaconazole 400 mg, vinflunine every 3 wks, ketaconazole C1 only, variable duration
12027270|NCT00388544|Behavioral|Activity matched to interest|Recreational activities are tailored to subject's style of interest
12027271|NCT00388544|Behavioral|Activity matched to function|Recreational activities are tailored to subjects physical and cognitive functioning
12027272|NCT00388544|Behavioral|Activity matched to both interest and function|Recreational activities are tailored to both style of interest and physical and cognitive functioning.
12027273|NCT00388531|Drug|Depocyte®|Depocyte® is a cytostatic drug
12027274|NCT00388518|Drug|Actos|45mg po daily
12027275|NCT00388518|Drug|Placebo|po daily
12027276|NCT00388518|Drug|aleglitazar|Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
12027277|NCT00388505|Drug|Tobramycin Inhalation Powder|Tobramycin Inhalation Powder (TIP) capsules for inhalation.
12027278|NCT00388505|Drug|Tobramycin Solution for Inhalation|Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer
12027279|NCT00388479|Drug|Alvimopan|
12027280|NCT00388466|Device|GALILEO|
12027281|NCT00388453|Device|Dx-pH Probe|24 hour ph monitoring
12027282|NCT00388453|Procedure|Manometry|procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)
12027283|NCT00388440|Biological|MMR vaccine (Priorix)|
12027284|NCT00388427|Drug|Dasatinib (BMS-354825)|100 mg, 150 mg, or 200 mg per dose escalation schedule; continuous oral dosing on Days 1-21 of each 21-day cycle until progression or unacceptable toxicity develops.
12027285|NCT00388427|Drug|Cetuximab (Erbitux, C225)|Loading dose of IV 400 mg/m^2 on Day 1 of Cycle 1; IV 250 mg/m^2 weekly thereafter each 21-day cycle until progression or unacceptable toxicity develops.
12027286|NCT00388414|Drug|duloxetine|30-60mg of duloxetine daily
12027287|NCT00388414|Drug|Placebo|Placebo pill once daily
12027288|NCT00388401|Drug|Alvimopan|
12027289|NCT00388388|Drug|losartan, hydrochlorothiazide|Losartan, 50-100 mg per day, once a day, for 6 months. Hydrochlorothiazide, 12.5-25 mg per day, once a day, for 6 months.
12027290|NCT00388375|Procedure|Ultrasound|limited ultrasound examination to evaluate the following areas: Examination of the subclavian and internal jugular veins to assess proper catheter placement PTX detection, using lung sliding and comet-tail artifact Visualization of the heart (right atrium and ventricle) and the inferior vena cava through the subcostal window
12027291|NCT00388362|Drug|Sirolimus|Patients will receive sirolimus at 2 mg/day orally with monitoring of trough drug levels weekly for 2 weeks to achieve trough drug levels 7-12 ng/ml. Along with prednisone therapy.
12027292|NCT00388362|Drug|Prednisone|Prednisone therapy will remain at the dose the patient received at the time sirolimus was begun. Withdrawal of prednisone will began after first evidence of improvement of chronic GVHD.
12027293|NCT00388349|Drug|Gemcitabine|
12027294|NCT00388349|Drug|Vinorelbine|
12027295|NCT00388349|Drug|Carmustine|
12027296|NCT00388349|Drug|Etoposide|
12027297|NCT00388349|Drug|Cyclophosphamide|
12027298|NCT00388349|Procedure|Autologous HCT|
12027299|NCT00388336|Drug|Epoetin Alfa|
12027300|NCT00388323|Other|blood and biopsies|blood and biopsies
12027301|NCT00388310|Procedure|Culture|Culture
12027302|NCT00388297|Drug|Levothyroxine|Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery.
12027303|NCT00388297|Drug|Placebo for Levothyroxine|
12027304|NCT00388284|Device|Arterial Sealing|
12027305|NCT00388271|Drug|Alfuzosin (Xatral)|standard treatment plus alfuzosin
12027306|NCT00388271|Drug|standard treatment|standard treatment
12027307|NCT00388258|Drug|Alvimopan|
12027308|NCT00388245|Procedure|Percutaneous Coronary Intervention|
12027309|NCT00388245|Procedure|Coronary Artery Bypass Grafting|
12027310|NCT00388219|Drug|Transtec (R) PRO (buprenorphine)|
12027311|NCT00388193|Drug|RITUXIMAB|375 mg/m2/d day 1
12027312|NCT00388180|Drug|GW501516|
12027313|NCT00388180|Drug|GW590735|
12027314|NCT00388167|Drug|Caspofungin|The patients are treated with 70 mg IV of caspofungin on day 1, followed by 50 mg/day IV during the rest of treatment
12027315|NCT00388154|Drug|Gemcitabine|900 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
12027316|NCT00388154|Drug|Cisplatin|30 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
12027317|NCT00388141|Behavioral|NIDCAP|Systematic care, where the mother and the nurses organize the caring on behalf of the preterm infants' ressources and developmental capacity such as the infant avoid over stimulation and distress
12027318|NCT00388128|Drug|Caffeine 6mg/kg|Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing
12027319|NCT00388115|Procedure|conventional surgery|Standard of care lumpectomy or mastectomy following RFA
12027320|NCT00388115|Procedure|neoadjuvant therapy|Standard of care lumpectomy or mastectomy following RFA
12027321|NCT00388115|Procedure|radiofrequency ablation|A small diameter needle is inserted through the skin and directly into the tumor for the purpose of supplying RF current. Initial power of the RF generator will start at 5-10 watts. The power will increase by 5-10 watts every minute until impedance of the system automatically stops the RF treatment.
12027550|NCT00386425|Drug|Drotrecogin alfa (activated)|intravenous
12027322|NCT00388089|Drug|bortezomib|Dose level A: 1 mg/m2; Dose level B: 1.3 mg/m2; Dose level C: 1.6 mg/m2; Dose level D: 1.6 mg/m2
12027323|NCT00388089|Drug|topotecan hydrochloride|Dose level A: 3 mg/m2; Dose level B: 3 mg/m2; Dose level C: 3 mg/m2; Dose level D: 4 mg/m2
12027324|NCT00388089|Other|flow cytometry|No description
12027325|NCT00388089|Other|immunoenzyme technique|No description
12027326|NCT00388089|Other|immunohistochemistry staining method|No description
12027327|NCT00388089|Other|laboratory biomarker analysis|No description
12027328|NCT00388076|Drug|Pazopanib|pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3
12027329|NCT00388076|Drug|Lapatinib|Lapatinib in combination with pazopanib and paclitaxel in Part 3
12027330|NCT00388076|Drug|paclitaxel|in combination with pazopanib
12027331|NCT00388076|Drug|carboplatin|in combination with pazopanib
12027332|NCT00388063|Drug|Atiprimod|oral, 14 days on / 14 days off; 30mg capsules
12027333|NCT00388050|Behavioral|Diabetes Medication Choice decision aid|The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
12027334|NCT00388050|Behavioral|Usual Care|Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
12027335|NCT00388037|Drug|sunitinib malate|Given PO
12027336|NCT00388037|Other|laboratory biomarker analysis|Correlative studies
12027337|NCT00388011|Drug|Intranasal Morphine (MNS075) 3.75 mg|Intranasal Morphine (MNS075) 3.75 mg
12027338|NCT00388011|Drug|Intravenous Morphine 7.5 mg|Intravenous Morphine 7.5 mg
12027339|NCT00388011|Drug|Intranasal morphine (MNS075) 7.5 mg|Intranasal morphine (MNS075) 7.5 mg
12027340|NCT00388011|Drug|Intranasal morphine (MNS075) 15 mg|Intranasal morphine (MNS075) 15 mg
12027341|NCT00388011|Drug|Intranasal morphine (MNS075) 30 mg|Intranasal morphine (MNS075) 30 mg
12027342|NCT00388011|Drug|Intranasal placebo|Intranasal placebo
12027343|NCT00387998|Other|AHRQ staying healthy booklet|educational booklet about prevention
12027344|NCT00387998|Other|Risk primer|Know your chances booklet
12027345|NCT00387985|Drug|MOA-728|
12027346|NCT00387972|Drug|denagliptin (GW823093)|
12027347|NCT00387959|Biological|filgrastim|
12027348|NCT00387959|Biological|rituximab|
12027349|NCT00387959|Drug|cyclophosphamide|
12027350|NCT00387959|Drug|cyclosporine|
12027351|NCT00387959|Drug|fludarabine phosphate|
12027352|NCT00387959|Drug|mycophenolate mofetil|
12027353|NCT00387959|Procedure|allogeneic hematopoietic stem cell transplantation|
12027354|NCT00387959|Procedure|umbilical cord blood transplantation|
12027355|NCT00387959|Radiation|total-body irradiation|
12027356|NCT00387946|Drug|SSR591813L (dianicline)|
12027357|NCT00387933|Drug|hydroxyurea|
12027358|NCT00387933|Drug|imatinib mesylate|
12027359|NCT00387933|Drug|vatalanib|
12027360|NCT00387920|Drug|sunitinib malate|Given orally
12027361|NCT00387920|Other|pharmacological study|Correlative studies
12027362|NCT00387920|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
12027363|NCT00387920|Other|laboratory biomarker analysis|Correlative studies
12027364|NCT00387907|Drug|larotaxel (XRP9881)|administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
12027365|NCT00387907|Drug|trastuzumab|administered as a 90-minute IV infusion on Day 1 of every week (qw)
12027366|NCT00387894|Drug|erlotinib hydrochloride|Tarceva will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
12027367|NCT00387881|Drug|sumatriptan succinate / naproxen sodium|sumatriptan 85mg / naproxen sodium 500mg
12027368|NCT00387881|Drug|Placebo|Placebo to match Treximet tablets
12027369|NCT00387868|Drug|cisplatin and etoposide|Cisplatin: 50mg/m2 - administered on days 1,8,29&36 Etoposide: 50 mg/m2 - administered on days 1-5 & 29-33
12027370|NCT00387868|Procedure|Surgical Resection|Resection will take place 4-8 weeks after completion of radiotherapy.
12027371|NCT00387868|Radiation|Concurrent Radiotherapy|Preoperative External Beam Radiotherapy
12027372|NCT00387855|Behavioral|SOS program|screening and didactic programming to raise awareness of depression suicidality
12027373|NCT00387842|Procedure|Laparoscopic surgery|
12027374|NCT00387842|Procedure|Conventional surgery|
12027375|NCT00387829|Device|DuraGen Plus Adhesion Barrier Matrix|Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
12027376|NCT00387803|Device|Cardiac Resynchronization Therapy with Defibrillation|
12027377|NCT00387790|Drug|motexafin gadolinium|Given IV
12027378|NCT00387790|Radiation|3-dimensional conformal radiation therapy|Undergo focal cranial radiotherapy
12027379|NCT00387777|Drug|Patch with centrally acting analgesic|
12027380|NCT00387777|Drug|Transtec(R) PRO (buprenorphine)|
12027381|NCT00387764|Drug|pazopanib|800 mg daily dosing continously until progression
12027382|NCT00387751|Biological|Bevacizumab|Given IV
12027383|NCT00387751|Other|Laboratory Biomarker Analysis|Correlative studies
12027384|NCT00387751|Other|Pharmacological Study|Correlative studies
12027385|NCT00387751|Drug|Sorafenib Tosylate|Given orally
12027386|NCT00387738|Biological|Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate|Escalating doses, 6 weekly subcutaneous (under the skin) injections
12027387|NCT00387738|Biological|Histamine base|Escalating doses, 6 weekly subcutaneous (under the skin) injections
12027388|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
12027389|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
12027390|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
12027392|NCT00387712|Other|Velocity based treadmill training|6 month of progressive treadmill walking with a safety harness and hand rail support to prevent falls. Treadmill speed is gradually progressed to meet the training heart rate goals for moderate aerobic exercise, when hemiparetic gait velocity can no longer be progressed, incline is added to achieve heart rate training goals. Progression is also based on participant's tolerance, abilities and safety.
12027393|NCT00387712|Other|Duration based treadmill training|6 month of progressive treadmill walking with a safety harness and hand rail support to prevent falls. Treadmill duration is gradually progressed to meet the endurance goals for low aerobic intensity exercise, gait velocity and incline do not progress. Progression is based on participant's tolerance, abilities and safety.
12027394|NCT00387699|Biological|bevacizumab|
12027395|NCT00387699|Drug|cisplatin|
12027396|NCT00387699|Drug|etoposide|
12027397|NCT00387699|Radiation|radiation therapy|
12027398|NCT00387686|Drug|rhBMP-2/CPM|
12027399|NCT00387686|Drug|rhBMP-2/CPM|
12027400|NCT00387686|Drug|rhBMP-2/CPM|
12027401|NCT00387686|Drug|rhBMP-2/CPM|
12027402|NCT00387673|Behavioral|Somatosensory Stimulation and Massed Practice Training|a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
12027403|NCT00387660|Drug|carboplatin|Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
12027404|NCT00387660|Drug|irinotecan|Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
12027405|NCT00387647|Drug|Azacitidine|Azacitidine given subcutaneously as outlined in treatment arm.
12027406|NCT00387634|Biological|TBE vaccine for adults|Serology blood draw.
12027407|NCT00387621|Drug|Nesiritide|The first 10 subjects in each group will receive a dose of 5 ug/kg and the next ten subjects will receive 10 ug/kg.
12027408|NCT00387621|Drug|Placebo|The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose.
12027409|NCT00387621|Drug|Saline|Normal saline 0.9% 0.25 ml/kg/min for 60 minutes
12027410|NCT00387608|Drug|veliparib|
12027411|NCT00387608|Other|pharmacological study|
12027412|NCT00387608|Procedure|biopsy|
12027413|NCT00387582|Drug|Ranibizumab (Lucentis)|Lucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.
12027414|NCT00387582|Procedure|Argon Laser|Argon laser at entry to trial and then per protocol for the duration of the study.
12027415|NCT00387569|Biological|MnB vaccine rLP8026|MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
12027416|NCT00387569|Biological|MnB vaccine rLP8026|MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
12027417|NCT00387569|Biological|MnB vaccine rLP8026|MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
12027418|NCT00387556|Drug|Ondansetron|ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
12027419|NCT00387530|Drug|oral sodium phenylbutyrate|
12027420|NCT00387530|Drug|valganciclovir|
12027421|NCT00387530|Genetic|polymerase chain reaction|
12027422|NCT00387530|Genetic|protein expression analysis|
12027423|NCT00387530|Procedure|biopsy|
12027424|NCT00387517|Drug|Aliskiren/HCTZ|
12027425|NCT00387504|Drug|fenretinide|4-HPR (Fenretinide) is given as a continuous intravenous infusion (CIV) for five consecutive days. Cycle is repeated every 3 weeks, if PR, CR or stable disease for 6 cycles.
12027426|NCT00387504|Other|pharmacological study|samples drawn per protocol
12027427|NCT00387491|Drug|MOA-728|
12027428|NCT00387478|Biological|Tree MATA MPL or Tree MATA|"4 injections of increasing dose strength for Tree MATA MPL or Tree MATA:
~600 SU/0.5 ml
~1600 SU/0.5 ml
~4000 SU/0.5 ml
~4000 SU/0.6 ml
~4 injections of 0.5 mL of 2% w/v L-tyrosine for Placebo"
12027429|NCT00387465|Drug|Azacitidine 30mg/m2|Azacitidine 30mg/m2 subcutaneously (SQ)
12027430|NCT00387465|Drug|Entinostat|7mg by mouth (PO) on days 3 and 10 of each cycle
12027431|NCT00387465|Drug|Azacitidine 40mg/m2|Azacitidine 40mg/m2 SQ
12027432|NCT00387452|Behavioral|Aerobic Exercise and Strength Exercise|6 months of aerobic training exercise. regulated by heart rate; work up to 80% of maximal heart rate on treadmill or stationary bike; 3 hours a week, 90% attendance.
12027433|NCT00387452|Behavioral|Strength training|6 months of strength training exercise using weight machines involving legs and arms: 12-15 repetitions of weights per exercise; 3 hours a week, 90% attendance.
12027434|NCT00387439|Behavioral|standard medical treatment + anoperineal physiotherapy.|
12027435|NCT00387439|Behavioral|Standard medical treatment|
12027436|NCT00387426|Drug|sunitinib malate|Given PO
12027437|NCT00387413|Drug|Duloxetine|Subjects will be receive hard gelatin capsules of Duloxetine at 30mg once daily for one week and 60mg once daily for the second week in Treatment Arm B.
12027438|NCT00387413|Drug|GSK189254|Subjects will receive film coated tablet of GSK189254 at 50 mcg once daily for a one week and 100 mcg once daily for the second week in Treatment Arm A.
12027439|NCT00387413|Drug|GSK189254 Placebo|Subjects will receive Placebo matching GSK189254 for 3 weeks in each period.
12027440|NCT00387413|Drug|Duloxetine Placebo|Subjects will receive Placebo matching Duloxetine for 3 weeks in each period.
12027441|NCT00387400|Drug|everolimus|150 mg/m2/day PO Daily x 5, q 4 weeks
12027442|NCT00387400|Drug|temozolomide|2.5 mg PO Daily, beginning day 2 of cycle 1, q 4 weeks
12027551|NCT00386412|Drug|Valganciclovir|900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks
12027443|NCT00387400|Genetic|microarray analysis|Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.
12027444|NCT00387400|Other|immunohistochemistry staining method|Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.
12027445|NCT00387387|Drug|Pazopanib|Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
12027446|NCT00387387|Drug|FOLFOX 6|FOLFOX 6 treatment consists of intravenous (IV) oxaliplatin (100 milligram per meter^2[mg/m^2]), and folinic acid (400 mg/m^2), IV 5-fluorouracil bolus (400 mg/m^2) followed by IV 5-fluorouracil (2400 to 3000 mg/m^2) infusion over 48 hours on Day 1 of every 14-day cycle.
12027447|NCT00387387|Drug|CapeOx|CapeOx treatment consists of IV oxaliplatin (130 mg/m^2) on Day 1 plus oral capecitabine (1000 mg/m^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment will be administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine will be reduced to 850 mg/m^2 twice daily.
12027448|NCT00387374|Biological|bevacizumab|Given IV
12027449|NCT00387374|Drug|paclitaxel|Given IV
12027450|NCT00387374|Drug|carboplatin|Given IV
12027451|NCT00387374|Radiation|radiation therapy|Undergo radiotherapy
12027452|NCT00387361|Procedure|Osteopathic Manipulative Treatment|20 minute post-operative osteopathic manipulation as described in the protocol
12027453|NCT00387348|Drug|escitalopram oxalate|escitalopram oxalate 10 mg once daily for 4 weeks
12027454|NCT00387348|Drug|Placebo|one placebo pill identical in appearance to the escitalpram pill once daily
12027455|NCT00387335|Drug|sunitinib malate|Given orally
12027456|NCT00387322|Drug|erlotinib hydrochloride|Given orally
12027457|NCT00387322|Drug|pemetrexed disodium|Given IV
12027458|NCT00387309|Drug|Methylnaltrexone (MOA-728)|
12027459|NCT00387296|Device|functional microarray|functional microarray application
12027460|NCT00387283|Drug|AVI-4020 Injection|
12027461|NCT00387270|Drug|Dimebon|Dimebon 10 or 20 mg TID x 7 days
12027462|NCT00387257|Drug|Rilapladib (SB-659032)|
12027463|NCT00387244|Device|Precision for Spinal Cord Stimulation|Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
12027464|NCT00387231|Procedure|Percutaneous coronary angioplasty/intervention (PCI)|
12027465|NCT00387231|Drug|Anti-ischemic drug therapy|
12027466|NCT00387218|Behavioral|Exercise, Physical therapy|
12027467|NCT00387205|Drug|Pazopanib|Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
12027468|NCT00387192|Drug|Optivate|Plasma-derived Factor VIII
12027469|NCT00387179|Drug|Melatonin|5mg, pill, once
12027470|NCT00387179|Drug|Methylxanthine|2.9 mg/kg, pill, once
12027471|NCT00387179|Procedure|Light Therapy|Bright light exposure
12027472|NCT00387153|Drug|MPC-2130|MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
12027473|NCT00387140|Drug|MK2295|
12027474|NCT00387127|Drug|Lapatinib oral tablets|Lapatinib is administered orally once daily.
12027475|NCT00387127|Drug|radiotherapy|Radiotherapy is given either as conventional fractionation using Two-dimensional (2D) or conformal techniques, or as Intensity Modulated Radiation Therapy (IMRT). Radiation therapy will be standardised throughout the study. Radiation therapy is given only once daily, with a dose/fraction not exceeding 2.5Gy, to a total dose of 65 Gy (IMRT) or 70 Gy (2D or 3D RT) to the gross site of disease .
12027476|NCT00387127|Drug|cisplatin chemotherapy|Cisplatin is administered intravenously at a dose of 100mg/m2 on days 1, 22 and 43 of radiotherapy (approximately Study Days 8, 29 and 50).
12027477|NCT00387114|Drug|Vitamin C|
12027478|NCT00387101|Device|Dermal - Living Skin Replacement (Dermal - LSR)|
12027479|NCT00387088|Device|Respimat|
12027480|NCT00387088|Drug|Tiotropium|
12027481|NCT00387075|Procedure|[123I]β-CIT and SPECT imaging|This study is designed as a prospective cohort study to test the strategy of combining two biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug, [123I]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish an 'at risk' Parkinson disease cohort without motor symptoms of PD.
12027482|NCT00387075|Drug|[123I]β-CIT|SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections),
12027483|NCT00387062|Device|Computer-based Cognitive Training|
12027484|NCT00387049|Behavioral|Anxiety Sensitivity Program for Smoking Cessation|
12027485|NCT00387036|Drug|Fluticasone|fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
12027486|NCT00387036|Drug|Comparator: Placebo|Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.
12027487|NCT00387023|Drug|Rituximab|250 mg/m^2 IV over 4-6 hours for 2 weeks.
12027488|NCT00387023|Drug|Zevalin|5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
12027552|NCT00386399|Drug|Mitomycin-C|Mitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity.
12027553|NCT00386386|Other|hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion|Above
12027554|NCT00386373|Drug|Imatinib Mesylate|Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).
12027555|NCT00386360|Drug|Placebo comparator|oral weekly for one year
12027556|NCT00386360|Drug|risedronate|35 mg risedronate, once a week for one year
12027557|NCT00386347|Drug|GSK364735 oral solution and oral tablets|
12027489|NCT00387010|Drug|Fentanyl Buccal Tablets|"Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.
~Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.
~Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily."
12027490|NCT00386997|Drug|liposomal amphotericin B (AmBisome®)|
12027491|NCT00386984|Drug|Somatostatin (octreotide)|
12027492|NCT00386971|Dietary Supplement|L-carnitine|3 grams daily in liquid form by mouth
12027493|NCT00386971|Other|placebo|1 oz sweet tasting liquid daily by mouth
12027494|NCT00386958|Drug|Povidone-Iodine|
12027495|NCT00386945|Behavioral|Brief counseling (Ask, Advise, Arrange)|Providers are trained to provide Ask, Advise and Arrange (brief cessation counseling) to all tobacco using patients. A Fax-to-Quit referral to a tobacco quit line and written materials on local cessation resources and pharmacotherapy are provided.
12027496|NCT00386919|Procedure|CyberKnife|
12027497|NCT00386906|Procedure|Sentinel Lymph Node Mapping and Biopsy|Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
12027498|NCT00386893|Procedure|simultaneous EEG/fMRI|fMRI/EEG recordings
12027499|NCT00386893|Device|fMRI|
12027500|NCT00386880|Other|Sounds|
12027501|NCT00386867|Drug|800 mcg misoprostol via oral or buccal administration|
12027502|NCT00386854|Behavioral|physical training|
12027503|NCT00386841|Drug|Escitalopram|Escitalopram 10 mg p.o. per day
12027504|NCT00386841|Drug|Placebo|Placebo
12027505|NCT00386828|Drug|Bevacizumab:|
12027506|NCT00386815|Drug|pemetrexed|
12027507|NCT00386815|Drug|cisplatin|
12027508|NCT00386802|Drug|Antifungal drug. VORICONAZOL. (VFEND®)|I.V charge dose 6 mg/kg/12h (2 doses) Maintenance iv treatment 4 mg/kg/12h during 6 days, followed by oral treatment (200 mg/12h)
12027509|NCT00386776|Other|Computer-based medical history|The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
12027510|NCT00386763|Drug|Artemether-lumefantrine|
12027511|NCT00386750|Drug|Artemether-lumefantrine|
12027512|NCT00386724|Device|Precision Spinal Cord Stimulation System|Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
12027513|NCT00386724|Device|Artisan Surgical Lead|Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
12027514|NCT00386711|Behavioral|training on identification of suicide risk and depression|
12027515|NCT00386698|Biological|Fluarix|
12027516|NCT00386698|Biological|adjuvanted influenza vaccine|
12027517|NCT00386685|Drug|larotaxel (XRP9881)|intravenous administration
12027518|NCT00386685|Drug|trastuzumab|intravenous administration
12027519|NCT00386672|Dietary Supplement|Reduced energy (lite) OJ fortified with Calcium and Vitamin D|Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.
12027520|NCT00386672|Behavioral|Nutrition Counseling|Individual and group nutritional counseling by a registered dietician.
12027521|NCT00386672|Dietary Supplement|Reduced energy (lite) OJ without Calcium and Vitamin D|Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day.
12027522|NCT00386659|Drug|tenofovir + abacavir + lopinavir/ritonavir|
12027523|NCT00386659|Drug|tenofovir + abacavir + efavirenz|
12027524|NCT00386646|Drug|0.5% carboxymethylcellulose (CMC) with purite and CMC alone|
12027525|NCT00386633|Biological|MVA-mBN32|3 immunizations; first study group: 10E7_TCID50
12027526|NCT00386633|Biological|MVA-mBN32|3 immunizations; second study group: 10E8_TCID50
12027527|NCT00386620|Behavioral|Questionnaire|45 minute survey about health, pain and relationships
12027528|NCT00386620|Behavioral|Interview|Feedback on use of handheld computer electronic diaries (ED).
12027529|NCT00386607|Drug|Aliskiren|Aliskiren 300 mg
12027530|NCT00386607|Drug|Valsartan|Valsartan 320 mg
12027531|NCT00386607|Drug|Hydrochlorothiazide (HCTZ)|Hydrochlorothiazide (HCTZ) 12.5-25 mg
12027532|NCT00386594|Drug|852A|
12027533|NCT00386581|Drug|atomoxetine|
12027534|NCT00386581|Drug|placebo|
12027535|NCT00386555|Drug|docetaxel|
12027536|NCT00386555|Drug|CP-868,596 + docetaxel|
12027537|NCT00386555|Drug|AG-013736 + docetaxel|
12027538|NCT00386555|Drug|CP-868,596 + AG-013736 + docetaxel|
12027539|NCT00386542|Biological|Vaxigrip® trivalent inactivated influenza vaccine|See full description elsewhere in this record.
12027540|NCT00386542|Device|Intradermal spacer on Biojector® 2000 jet injector|See elsewhere in this record for full description.
12027541|NCT00386529|Drug|Aspirin enteric coated pellests 100mg|
12027542|NCT00386516|Drug|GM-CT-01|GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression
12027543|NCT00386516|Drug|5-Fluorouracil|5-FU given IV by infusion for 30, at 600 mg/m2 in combination with GM-CT-01 for 4 consecutive days in 28 days cycle until disease progression
12027544|NCT00386503|Drug|Artesunate + Amodiaquine|
12027545|NCT00386490|Drug|larazotide acetate|capsule for oral administration
12027546|NCT00386477|Procedure|Vaginal cleansing before cesarean delivery|Cleansing vagina with 1% betadine scrub before cesarean.
12027547|NCT00386464|Device|noninvasive positive pressure ventilation|
12027548|NCT00386451|Device|Catheter locking systems|
12027549|NCT00386438|Procedure|Honan balloon application|
12027558|NCT00386334|Drug|Eszopiclone|2 mg tablet once per day in the evening
12027559|NCT00386334|Drug|Placebo|Tablet one per day in the evening.
12027560|NCT00386321|Drug|Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)|
12027561|NCT00386308|Drug|Tranexamic acid tablets|3900 mg/Day
12027562|NCT00386308|Drug|Placebo tablets|
12027563|NCT00386282|Drug|mifepristone-misoprostol treatment|200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.
12027564|NCT00386269|Drug|Codeine Phosphate Analgesia|
12027565|NCT00386256|Device|Health Buddy, Home telehealth technology|Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
12027566|NCT00386256|Other|Telephone counseling|
12027567|NCT00386243|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
12027568|NCT00386243|Behavioral|Pain self-management program|The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
12027569|NCT00386243|Drug|Co-Analgesic Therapy|"Amitriptyline, start at 10-25, titrate to 100 mg Nortriptyline, start at 10-25, titrate to 100 mg
~Gabapentin, titrate up to 900-1200 tid venlafaxine, carbemazepine, duloxetine, and/or pregabalin
~Cyclobenzaprine, titrate to 10 mg TID fluoxetine, sertraline, citalopram"
12027570|NCT00386243|Drug|Opioid Analgesics|Tramadol 50 mg BID or TID and titrate to 100 mg QID Acetaminophen/codeine (300mg/30mg). Take 1 or 2 tablets qid prn pain Acetaminophen/hydrocodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Acetaminophen/oxycodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Morphine SR (30mg). Start at 30 mg twice a day (titrate up to 240mg/day if needed) Methadone (5-10mg). Start at 5mg bid; titrate 10mg tid (max 20mg tid)
12027571|NCT00386230|Drug|ZDV Short (mother)-Short (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Sinfant)
12027572|NCT00386230|Drug|ZDV Short (mother)-Long (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Linfant)
12027573|NCT00386230|Drug|ZDV Long (mother)-Short (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Sinfant)
12027574|NCT00386230|Drug|ZDV Long (mother)-Long (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Linfant)
12027575|NCT00386217|Behavioral|Telephone Survey|Telephone interview, about 90 minutes, covering demographic information, medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing.
12027576|NCT00386204|Device|Q-switched Ruby Laser|
12027577|NCT00386191|Drug|clopidogrel (SR25990C)|oral administration
12027578|NCT00386178|Drug|Vitamin E supplement rich in gamma tocopherol|daily dose of Vitamin E supplement rich in gamma tocopherol
12027579|NCT00386165|Drug|larazotide acetate|larazotide acetate 4 mg capsules
12027580|NCT00386152|Drug|epoetin alfa|80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks
12027581|NCT00386152|Drug|darbepoetin alfa|500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks
12027582|NCT00386139|Drug|Aliskiren/HCTZ|
12027583|NCT00386126|Drug|Iron Sucrose IV 200mg, once a week, for 5 weeks|
12027584|NCT00386126|Drug|Ferrous sulfate 200mg PO TID, for 8 weeks|
12027585|NCT00386113|Biological|Fluarix and adjuvanted influenza vaccine|
12027586|NCT00386100|Drug|Avandamet 6 mg/1500 mg (ttd)|One 2 mg/ 500 mg capsule will be taken in the AM with the morning meal Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal
12027587|NCT00386100|Drug|Avandamet 4 mg/1000 mg (ttd)|One 2 mg/500 mg capsule will be taken in the AM with the morning meal. One 2 mg/500 mg capsule will be taken in the PM with the evening meal.
12027588|NCT00386100|Drug|Avandamet 2 mg/500 mg (ttd)|one placebo capsule will be taken in the AM with the morning meal one 2 mg/ 500 mg capsule will be taken in the PM with the evening meal.
12027589|NCT00386100|Drug|Avandamet 8 mg/ 2000 mg (ttd)|Two 2 mg/ 500 mg capsules will be taken in the AM with the morning meal. Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal.
12027590|NCT00386100|Drug|Metformin 500 mg (ttd)|One placebo capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.
12027591|NCT00386100|Drug|Metformin 1000 mg (ttd)|One 500 mg capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.
12027592|NCT00386100|Drug|Metformin 1500 mg (ttd)|One 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsules will be taken in the PM with the evening meal.
12027593|NCT00386100|Drug|Metformin 2000 mg (ttd)|Two 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsule will be taken in the PM with the evening meal.
12027594|NCT00386087|Drug|Enzastaurin Hydrochloride|
12027595|NCT00386074|Drug|NaFeEDTA, Electrolytic Iron|
12027596|NCT00386061|Drug|rimonabant (SR141716)|
12027643|NCT00385736|Biological|adalimumab|Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
12027644|NCT00385736|Biological|adalimumab|Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
12027597|NCT00386048|Behavioral|Brief Cognitive-Behavioral Pain Management Training|Participants complete a manualized, single session of training which includes: (A) education about the causes of sickle cell pain, (B) education about how the nervous system processes pain signals, and (C) explanations of how one can use cognitive and behavioral treatment (CBT) strategies to decrease the extent of pain experienced (all based on how the nervous system processes pain). Four specific CBT skills are taught and practiced by the participant (Progressive muscle relaxation, Controlled Deep Breathing, Imagery, and Distraction). The protocol explicitly emphasizes the use of CBT as a complimentary pain management tool to use in addition to the standard of care methods.
12027598|NCT00386035|Drug|Delayed ART|Participants follow a drug conservation (DC) regimen in which ART is stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count is at least 350 cells/mm3, and then are followed by episodic ART based on CD4 cell count.
12027599|NCT00386035|Drug|Continuous ART|Group 2 participants follow a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.
12027600|NCT00386022|Drug|GnRH|GnRH doses of 25, 75, 250 and 750 ng/kg will be given IV every 4 hr at baseline and after transdermal estradiol
12027601|NCT00386022|Drug|NAL-GLU GnRH antagonist|A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg before and after transdermal estradiol
12027602|NCT00386022|Drug|Estrogen patch|transdermal estrogen patches 0.05mg/day, changing the patch every 86 hr in second part of sequential study
12027603|NCT00386009|Drug|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
12027604|NCT00386009|Drug|Placebo|Placebo tablet taken by mouth once a day for 12 weeks.
12027605|NCT00385996|Drug|Tarceva (Erlotinib)|Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.
12027606|NCT00385983|Device|Harmonic Scalpel|
12027607|NCT00385970|Drug|Tegafur-uracil (UFT)|From within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
12027608|NCT00385970|Drug|Calcium folinate (LV)|From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
12027609|NCT00385970|Drug|Krestin (PSK)|From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
12027610|NCT00385957|Drug|AZT+3TC+IDV+RTV|
12027611|NCT00385957|Drug|AZT+3TC+EFV|
12027612|NCT00385944|Drug|Prasugrel|Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.
12027613|NCT00385944|Drug|Clopidogrel|Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.
12027614|NCT00385931|Drug|Valsartan and simvastatin|
12027615|NCT00385918|Device|Lokomat Training|The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.
12027616|NCT00385918|Other|Home stretching then Lokomat training|Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. After 3 months the patients will be crossed over to Lokomat training for an additional 3 months. This training will be the same as given to the individuals originally randomized to the Lokomat treatment intervention.
12027617|NCT00385905|Device|Excel Drug-eluting stent|
12027618|NCT00385892|Device|Abdominal binder|
12027619|NCT00385879|Behavioral|Case management|
12027620|NCT00385866|Behavioral|cancer screening and health education|The control group will receive cancer screening and health education materials on a quarterly basis but will not have access to patient navigation services.
12027621|NCT00385866|Behavioral|facilitation of Services to improve cancer screening|The intervention group will receive cancer education and faciliation of services in the form of patient navigation
12027622|NCT00385853|Drug|PTK787/ZK 222584|Twice daily for each 28-day cycle
12027623|NCT00385853|Drug|Temozolomide|Daily for each 28-day cycle
12027624|NCT00385853|Procedure|Radiation Therapy|For 7 weeks beginning on day 5 of the first treatment cycle
12027625|NCT00385840|Biological|Influenza Vaccine GSK1247446A|Single dose, intramuscular injection
12027626|NCT00385840|Biological|FluarixTM|Single dose, intramuscular injection
12027627|NCT00385827|Drug|Mitoxantrone|Mitoxantrone 12 mg/m^2 intravenously as a 30 minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2)
12027628|NCT00385827|Drug|Siltuximab|Siltuximab 6 mg/kg intravenously as a 2 hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year
12027629|NCT00385827|Drug|Prednisone|Prednisone 5 mg orally twice daily
12027630|NCT00385801|Drug|Risperidone|
12027631|NCT00385801|Drug|Placebo|
12027632|NCT00385788|Drug|Gemcitabine|800 mg/m^2 IV over 30 minutes on Day -7 (1 day)
12027633|NCT00385788|Drug|Fludarabine|33 mg/m^2 IV over 30 minutes Day -5 to Day -2 (4 days)
12027634|NCT00385788|Drug|Melphalan|70 mg/m^2 IV over 30 minutes on Day -3 to Day -2 (2 days)
12027635|NCT00385788|Drug|Antithymocyte Globulin|"2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation.
~If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant."
12027636|NCT00385788|Procedure|Allogeneic Stem Cell Infusion|Infusion of stem cells on Day 0.
12027637|NCT00385788|Drug|Tacrolimus|0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.
12027638|NCT00385788|Drug|Filgrastim (G-CSF)|Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
12027639|NCT00385788|Drug|Methotrexate|5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.
12027640|NCT00385775|Drug|AEG35156|weekly IV solution infused over 2 hrs
12027641|NCT00385762|Drug|paroxetine|paroxetine 10-40mg daily x 5 weeks
12027642|NCT00385749|Device|RV apical vs RV septal defibrillation threshold testing|
12027645|NCT00385736|Biological|placebo|Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing. Subjects received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab eow thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
12027646|NCT00385723|Dietary Supplement|Omega 3 (Fish Oil) Supplementation|1.25 g or 2.496 g daily for 4 months
12027647|NCT00385723|Dietary Supplement|Placebo|matching placebo capsule daily for 4 months
12027648|NCT00385710|Drug|valproic acid|Depakine
12027649|NCT00385710|Drug|Placebo|Placebo
12027650|NCT00385697|Drug|Teplizumab|IV dosing daily for 14 days times 2 courses
12027651|NCT00385697|Other|Placebo|IV dosing daily for 14 days times 2 courses
12027652|NCT00385684|Drug|hydrocodone/APAP w placebo PRN|Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID). With liquid placebo available PRN.
12027653|NCT00385684|Drug|hydrocodone/APAP|Participants judged as responders during Phase A continue the same dose of study medication (hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID). Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen.
12027654|NCT00385684|Drug|placebo with hydrocodone/APAP PRN|Liquid placebo PRN. Also available PRN is Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid.
12027655|NCT00385671|Drug|duloxetine hydrochloride|Duloxetine (DLX) once daily (QD), orally (PO)
12027656|NCT00385671|Drug|pregabalin|Pregabalin (PGB) orally (PO)
12027657|NCT00385671|Drug|gabapentin|Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)
12027658|NCT00385658|Drug|Fluvastatin extended release, fenofibrate|
12027659|NCT00385658|Drug|Fixed combination simvastatin/ezetimibe|
12027660|NCT00385645|Drug|Combivir+Kaletra|
12027661|NCT00385645|Drug|Combivir+Reyataz|
12027662|NCT00385632|Drug|Antiretroviral Regimens|Various antiretroviral therapy combinations already being administered to participants
12027663|NCT00385606|Drug|gemcitabine|
12027664|NCT00385606|Drug|prolonged continuous infusion gemcitabine|
12027665|NCT00385606|Drug|cisplatin|
12027666|NCT00385606|Drug|rofecoxib|
12027667|NCT00385593|Drug|Symbicort (budesonide/formoterol) Turbuhaler|
12027668|NCT00385593|Drug|Conventional treatment|
12027669|NCT00385580|Drug|dasatinib|Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression
12027670|NCT00385580|Drug|dasatinib|Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression
12027671|NCT00385567|Drug|PEHRG214|
12027672|NCT00385554|Drug|UC-781 carbomer gel, 0.1% and 0.25%|
12027673|NCT00385541|Drug|Morphine PCA|Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
12027674|NCT00385541|Drug|Hydromorphone PCA|hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
12027675|NCT00385528|Behavioral|Multi-faceted psychiatric intervention|
12027676|NCT00385515|Drug|SNX-1012 (meclocycline sulfosalicylate)|tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
12027677|NCT00385515|Drug|placebo|Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days
12027678|NCT00385502|Drug|EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)|nail lacquer applied daily for 48 weeks
12027679|NCT00385489|Drug|LXR-623|
12027680|NCT00385476|Behavioral|PMKT Questionnaire|Patient Medication Knowledge Tool - Questionnaire entailing the medications the patient is currently taking.
12027681|NCT00385463|Drug|Adding Advair Diskus 100/50mcg (FSC) BID and Singulair 10mg is added to placebo Diskus BID|
12027682|NCT00385450|Drug|Nelfinavir/placebo|1250mg/twice each day/four days.
12027683|NCT00385437|Behavioral|Driving Simulator Testing|
12027684|NCT00385437|Drug|Mirtazapine Treatment|
12027685|NCT00385411|Drug|valproate microgranules|20 to 30 mg/kg/day
12027686|NCT00385398|Drug|erlotinib hydrochloride|Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.
12027687|NCT00385398|Drug|temozolomide|Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.
12027688|NCT00385398|Radiation|stereotactic radiosurgery|Stereotactic radiosurgery will be performed prior to chemotherapy.
12027689|NCT00385385|Drug|Rifalazil|
12027690|NCT00385372|Procedure|elimination diet|
12027691|NCT00385372|Procedure|provocation diet|
12027692|NCT00385359|Procedure|aerosol drug deposition strategies|
12027693|NCT00385359|Drug|Albuterol|
12027694|NCT00385346|Behavioral|Expressive writing|Patients in the intervention group write on three day for 20 minutes about highly emotional topics In the control group patients write on three days for 20 minutes about topics with relatively low emotional involvement such as diet, time management and sport.
12027695|NCT00385333|Procedure|Feasibility Study - Imaging System|
12027696|NCT00385320|Biological|HRV vaccine|
12027697|NCT00385307|Drug|amibegron (SR58611A)|
12027698|NCT00385281|Biological|FluMist|
12027699|NCT00385268|Drug|acamprosate|1998 mg/dau fpr 8 weeks
12027700|NCT00385268|Drug|placebo|placebo pills
12027701|NCT00385255|Biological|Fluarix®|GSK Biologicals' inactivated influenza split virus vaccine.
12027702|NCT00385255|Biological|Boostrix®|GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
12027703|NCT00385242|Procedure|Positron emission tomography: FDG viability imaging|FDG PET viability imaging
12027704|NCT00385242|Other|PET imaging|PET viability imaging
12027705|NCT00385229|Drug|induction of labor|Misoprostol, Dinoprostone, amniotomy, Oxytocin
12027706|NCT00385216|Drug|Nicotine|Nicotine nasal spray 3mg x 1 before surgery
12027707|NCT00385216|Other|Placebo|Placebo nasal spray 0mg x 1 before surgery
12027708|NCT00385203|Drug|AZD2171|45 mg oral tablet once daily dose
12027709|NCT00385190|Drug|HCV-796|
12027710|NCT00385177|Drug|SN2310 Injectable Emulsion|Escalating doses given IV every three weeks
12027711|NCT00385164|Procedure|PET/CT scan for RT planning|
12027712|NCT00385138|Drug|Cangrelor|cangrelor bolus (30 mcg/kg) & cangrelor infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
12027713|NCT00385138|Drug|clopidogrel|clopidogrel capsules (600 mg) at end of PCI
12027714|NCT00385138|Drug|Placebo bolus & placebo infusion|placebo bolus (30 mcg/kg) & placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
12027715|NCT00385138|Drug|Placebo capsules - end of PCI|Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing
12027716|NCT00385138|Drug|Placebo capsules - end of infusion|Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
12027717|NCT00385125|Drug|Bendamustine|
12027718|NCT00385125|Drug|Rituximab|
12027719|NCT00385112|Procedure|Echocardiogram|2D echocardiogram with Doppler flow
12027720|NCT00385099|Drug|GW876008|
12027721|NCT00385086|Drug|TNF blocker|Treatment with TNF-alpha blocker
12027722|NCT00385086|Drug|Placebo|Treatment with placebo
12027723|NCT00385047|Biological|Group A FMP2.1/AS01B|
12027724|NCT00385047|Biological|Group B FMP2.1/AS02A|
12027725|NCT00385034|Device|Interactive computer based health-risk survey before doctor's visit|
12027726|NCT00385021|Drug|5-Fluorouracil, leucovorin, oxaliplatin, avastin|
12027727|NCT00385008|Drug|Combination Product (sumatriptan succinate / naproxen sodium)|sumatriptan/naproxen sodium
12027728|NCT00385008|Drug|RELPAX(eletriptan) 40mg Tablet|eletriptan tablets
12027729|NCT00384995|Drug|0.9% (154 mEq/L) IV Sodium Chloride|Saline solution
12027730|NCT00384995|Drug|1/6 M (166 mEq/L) IV Sodium Bicarbonate|Bicarbonate solution
12027731|NCT00384982|Procedure|Bone marrow-derived stem cells implantation|percutaneous BM-derived cell therapy
12027732|NCT00384969|Drug|RAD001 and Sorafenib|RAD001 2.5mg to 10.0mg PO QD Sorafenib 400mg PO BID
12027733|NCT00384956|Drug|Azacitidine|
12027734|NCT00384943|Behavioral|Moderate-intensity Exercise|
12027735|NCT00384930|Drug|tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
12027736|NCT00384930|Drug|tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks.
12027737|NCT00384930|Drug|tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks.
12027738|NCT00384930|Drug|tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks.
12027739|NCT00384930|Drug|placebo|Placebo tablet taken by mouth one a day for twelve weeks
12027740|NCT00384917|Drug|Ketoconazole|
12027741|NCT00384904|Drug|Atazanavir/Ritonavir|Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
12027742|NCT00384904|Drug|Atazanavir/Ritonavir + Famotidine|Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
12027743|NCT00384904|Drug|Atazanavir/Ritonavir + Famotidine|Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.
12027744|NCT00384904|Drug|Atazanavir/Ritonavir|Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.
12027745|NCT00384904|Drug|Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine|Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.
12027746|NCT00384904|Drug|Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine|Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.
12027747|NCT00384891|Device|Synergo + MMC|Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
12027748|NCT00384891|Drug|Bacillus Calmette-Guérin|Intravesical instillation with BCG (Bacillus Calmette-Guérin)
12027749|NCT00384878|Drug|Cetuximab, Cisplatin,5-Fluorouracil,Leucovorin|
12027750|NCT00384865|Drug|Simvastatin|Simvastatin 40 mg, taken orally, once a day for 6 months
12027751|NCT00384865|Drug|Aspirin|Aspirin 81 mg, taken orally, once a day for 6 months
12027752|NCT00384865|Drug|Placebo|Placebo, taken orally, once a day for 6 months
12027753|NCT00384852|Drug|rhBMP-2/CPM|
12027754|NCT00384839|Drug|azacitidine for injectable suspension|Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
12027755|NCT00384826|Drug|erlotinib|Erlotinib 150 mg/day (until progression)
12027756|NCT00384826|Drug|paclitaxel + carboplatine|Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)
12027757|NCT00384813|Behavioral|Project ASPIRE Home-Based Family Intervention|Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months
12027758|NCT00384813|Behavioral|Project ASPIRE Enhanced Treatment As Usual|Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
12027759|NCT00384800|Drug|Thalidomide(THADO), Tegafur/Uracil(UFUR)|
12027760|NCT00384787|Biological|VRC-HIVDNA009-00-VP|HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2
12027761|NCT00384787|Biological|VRC-HIVADV014-00-VP|Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6
12027762|NCT00384774|Drug|Lasmiditan|Administered as intravenous infusion
12027763|NCT00384774|Drug|Placebo|Administered as intravenous infusion
12027764|NCT00384748|Behavioral|TR intervention|The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during weeks 2, 4, 6, 8 and 12. One additional tele-visit may be scheduled as needed. The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. Visit 3 focuses on functional mobility using adaptive strategy component.
12027821|NCT00384254|Behavioral|3 A|Providers are trained to provide Ask, Advise and Arrange intervention to all tobacco using patients. Written materials, prescription for NRT and a Fax-to-Quit referral are provided.
12028253|NCT00381446|Device|Marketed contact lens care products|
12027765|NCT00384748|Behavioral|In-home messaging device.|The purpose of this aspect of the intervention is to screen for unforeseen problems and to reinforce adherence to the recommended treatment. It will be used to interface with patients daily, but briefly. The in-home messaging device, which resembles a caller ID box is attached to the home telephone line and electrical outlet. Installation of the equipment involves connecting it to the phone line and plugging it into an electrical outlet. The teletherapist receives the clinical data from the in-home messaging device via the internet on a daily basis. It is used to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence.
12027766|NCT00384748|Behavioral|Usual care|Routine VA care.
12027767|NCT00384722|Device|EASYTRAK 3 Downsize Lead|EASYTRAK 3 Downsize Lead
12027768|NCT00384696|Drug|Nicotine Replacement Therapy|4 Weeks of nicotine patch. Patch therapy for participants who smoke >10 cigarettes/day consists of 2 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches.
12027769|NCT00384696|Behavioral|Questionnaire|Survey taking 1 and 1/2 hours at each study visit.
12027770|NCT00384670|Biological|Dengue Vaccine Formulation 17|Tetravalent live attenuated DEN vaccine candidate. Containing dengue serotypes 1,2, and 3 vaccines produced at the Salk Institute and dengue serotype 4 produced at the WRAIR Pilot Bioproduction Facility. Dosage 1 mL administered via injection at Day 0 and Day 60.
12027771|NCT00384670|Biological|Licensed Japanese Encephalitis (JE) Vaccine|Produced by the Thailand GPO using a Beijing strain of JE in liquid form; dosed at 0.5 mL ot 7 and 7.5 months.
12027772|NCT00384657|Drug|iron sucrose|"Patients in Group I will receive iv iron sucrose, as described in the study protocol.
~Patient in Group II will receive conventional treatment for chronic heart failure."
12027773|NCT00384644|Device|NiRS measurment of tissue oxygenation|NiRS measurment of tissue oxygenation
12027774|NCT00384631|Other|subconjunctival normal saline|0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals
12027775|NCT00384631|Drug|Avastin|intravitreal injection of avastin 2.5mg repeated twice at monthly intervals
12027776|NCT00384618|Drug|pravastatin|
12027777|NCT00384618|Drug|vitamin E|
12027778|NCT00384605|Drug|taranabant|taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
12027779|NCT00384605|Drug|placebo|Placebo capsule once daily. Treatment for 52 weeks.
12027780|NCT00384592|Drug|Esomeprazole|
12027781|NCT00384592|Procedure|Physical exam|
12027782|NCT00384592|Procedure|Pregnancy test if applicable|
12027783|NCT00384579|Drug|Botulinum toxin B|Botulinum Toxin B
12027784|NCT00384579|Drug|Placebo|Placebo
12027785|NCT00384566|Drug|Carvedilol|anit hypertensive medication
12027786|NCT00384566|Drug|Metoprolol|Anti hypertensive medication
12027787|NCT00384553|Drug|Rituximab|
12027788|NCT00384553|Drug|DHAP|
12027789|NCT00384553|Drug|TEC|
12027790|NCT00384553|Drug|autologous stem cell transplantation|
12027791|NCT00384540|Procedure|Dobutamine stress echocardiography, coronarography, brachial arterial echography|DSE: cumulative doses of dobutamine (max = 40 µg/kg/min) and atropine (max = 1.5 mg), to reach a maximal heart rate under clinical, electrocardiographic and echocardiographic surveillancesCoronarography: invasive injection into coronary arteries of a radiological product showing a contrast visible on an x-ray. FMD: Flow-mediated dilatation of the brachial artery induced by 5-min forearm arterial occlusion
12027792|NCT00384527|Drug|Nitazoxanide|One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
12027793|NCT00384527|Drug|Vancomycin|One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.
12027794|NCT00384514|Device|VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors|
12027795|NCT00384501|Device|Intacs|
12027796|NCT00384488|Behavioral|Interactive Voice Response System (IVR)|
12027797|NCT00384475|Drug|Ciclesonide Nasal Spray|
12027798|NCT00384449|Drug|Ranibizumab|Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
12027799|NCT00384436|Drug|escitalopram|
12027800|NCT00384423|Drug|PRX-03140|
12027801|NCT00384410|Drug|Nabilone|
12027802|NCT00384397|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular
12027803|NCT00384397|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12027804|NCT00384397|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12027805|NCT00384384|Drug|oral 18B Glycyrrhetinic acid versus placebo|
12027806|NCT00384371|Drug|Botulinum Toxin A|Botulinum Toxin A
12027807|NCT00384371|Drug|Placebo|Placebo
12027808|NCT00384358|Drug|rhBMP-2/CPM|one time injection of 3-5 mL test article at time of internal fracture fixation
12027809|NCT00384358|Drug|rhBMP-2/CPM|one time injection of 3-5 mL test article at time of internal fracture fixation
12027810|NCT00384358|Other|surgical intervention alone|surgical internal fixation of fracture defines the standard of care group
12027811|NCT00384345|Device|Bright Light Therapy|
12027812|NCT00384345|Behavioral|Exercise|
12027813|NCT00384332|Drug|orally-disintegrating olanzapine|5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.
12027814|NCT00384332|Drug|regular olanzapine|5-20 mg. olanzapine daily for approximately 8 weeks.
12027815|NCT00384319|Device|ThermoSuit(R) System|The ThermoSuit device is used to cool patients using direct contact of the skin with cold water.
12027816|NCT00384306|Drug|prednisolone|
12027817|NCT00384293|Drug|Comparator: niacin (+) laropiprant (MK0524A)|niacin (+) laropiprant (2 g) po qd.
12027818|NCT00384293|Drug|Comparator: placebo|niacin (+) laropiprant (2 g) placebo po qd.
12027819|NCT00384280|Drug|Rifampin|
12027820|NCT00384254|Behavioral|5 A|Dental providers are trained to provide Ask, Advise, Assess, Assist and Arrange to all tobacco using patients. Written materials are provided, including information on local cessation resources, pharmacotherapy and tobacco quitlines.
12028246|NCT00381537|Drug|carbamazepine|
12028254|NCT00381433|Drug|AVI-4065 Injection|
12027822|NCT00384241|Behavioral|Induced Stress|Participation in an active coping task by playing a video game against another participant.
12027823|NCT00384241|Procedure|Buccal Swab|One Buccal swab collected from each parent
12027824|NCT00384228|Drug|Nilotinib|
12027825|NCT00384215|Drug|insulin glargine [rDNA origin] injection|
12027826|NCT00384202|Drug|Tacrolimus|Immunosuppression
12027827|NCT00384189|Drug|Ciclesonide|inhaled Ciclesonide
12027828|NCT00384189|Drug|Placebo|Ciclesonide placebo-matching inhaler
12027829|NCT00384189|Drug|Salbutamol|Salbutamol inhalation powder
12027830|NCT00384176|Drug|Cediranib|oral tablet once daily
12027831|NCT00384176|Drug|Bevacizumab|intravenous infusion
12027832|NCT00384176|Drug|5-fluorouracil ( in FOLFOX)|intravenous infusion
12027833|NCT00384176|Drug|Leucovorin (in FOLFOX)|intravenous infusion
12027834|NCT00384176|Drug|Oxaliplatin (in FOLFOX)|intravenous infusion
12027835|NCT00384150|Drug|galiximab in combination with rituximab|galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.
12027836|NCT00384137|Drug|Tacrolimus|Immunosuppression
12027837|NCT00384124|Drug|Imiquimod|Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site
12027838|NCT00384111|Drug|R-CVP + Zevalin Therapeutic Regimen|Standard R-CVP followed by Zevalin Theraeputic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
12027839|NCT00384111|Drug|R-CVP|Standard R-CVP
12027840|NCT00384098|Drug|CTA018 cream|
12027841|NCT00384085|Drug|Insulin Glulisine|Subcutaneous injection up to 1 injection per day
12027842|NCT00384085|Drug|Insulin Glargine|Subcutaneous injection once-a-day
12027843|NCT00384085|Drug|Premixed Insulin|Subcutaneous injection twice-a-day.
12027844|NCT00384085|Drug|Insulin Glulisine|Subcutaneous injection up to 3 injections per day.
12027845|NCT00384072|Drug|bazedoxifene BZA-20|
12027846|NCT00384059|Biological|13-valent Pneumococcal Conjugate Vaccine|Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
12027847|NCT00384059|Biological|7vPnC|Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
12027848|NCT00384059|Biological|Pediacel|concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
12027849|NCT00384059|Biological|NeisVac-C|concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
12027850|NCT00384059|Biological|Menitorix|concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
12027851|NCT00384046|Drug|Testosterone|patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
12027852|NCT00384046|Drug|Placebo|patch, placebo, patch changed every 3-4 days, 24 weeks
12027853|NCT00384033|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|50 mg tablet, once daily dosing for 8 weeks
12027854|NCT00384033|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|100 mg tablet, once daily dosing for 8 weeks
12027855|NCT00384033|Drug|Placebo|Matching placebo tablets and capsules, once daily dosing for 8 weeks
12027856|NCT00384033|Drug|Duloxetine 60 mg/day|60 mg capsule, once daily dosing for 8 weeks
12027857|NCT00384020|Drug|Paroxetine (Seroxat)|
12027858|NCT00384020|Drug|Escitalopram (Lexapro)|
12027859|NCT00384007|Procedure|Hydrodiscectomy with Spinejet|
12027860|NCT00383994|Drug|GM-CSF|250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
12027861|NCT00383994|Drug|Rituximab|375 mg/m^2 by vein followed by 1000 mg/m^2 weekly for 3 weeks for a total of 4 doses.
12027862|NCT00383994|Biological|NK Cell Infusion|NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.
12027863|NCT00383942|Drug|Misoprostol|Misoprostol,25 micrograms every 4 hours.
12027864|NCT00383942|Device|Catheter|A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
12027865|NCT00383929|Drug|Candesartan cilexetil|32mg oral
12027866|NCT00383929|Drug|Hydrochlorothiazide|12.5 mg oral
12027867|NCT00383929|Drug|Hydrochlorothiazide|25 mg oral
12027868|NCT00383916|Drug|pantoprazole|
12027869|NCT00383903|Biological|HRV vaccine|Two or three oral doses
12027870|NCT00383890|Drug|Dexmedetomidine HCL Injection|
12027871|NCT00383890|Drug|Placebo|
12027872|NCT00383877|Drug|insulin detemir|
12027873|NCT00383877|Drug|insulin NPH|
12027874|NCT00383864|Drug|Pegylated interferon and ribavirin|
12027875|NCT00383851|Drug|ATN-224|
12027876|NCT00383851|Drug|Temozolomide|
12027877|NCT00383838|Behavioral|brief, voluntary substance use intervention|
12027878|NCT00383825|Procedure|Anterior segment indocyanine green angiography|
12027879|NCT00383812|Drug|Intravitreal Bevacizumab|
12027880|NCT00383799|Drug|iv Amiodarone|
12027881|NCT00383799|Drug|iv Procainamide|
12027882|NCT00383786|Drug|NK1 Antagoist (GR205171)|
12027883|NCT00383786|Procedure|Psychophysiology (Trauma Script)|
12027884|NCT00383786|Procedure|Psychophysiology (Verbal Threat)|
12027885|NCT00383786|Procedure|Psychophysiology (Fear Conditioning)|
12027886|NCT00383786|Procedure|Psychophysiology (Affective Modulation)|
12027887|NCT00383786|Procedure|Psychophysiology (Heart rate variability)|
12027888|NCT00383786|Procedure|Lumbar Puncture|
12027889|NCT00383786|Procedure|24-hour plasma sampling|
12027890|NCT00383786|Procedure|MRI|
12027891|NCT00383773|Procedure|Retinal endo vascular surgery|
12027892|NCT00383760|Drug|eribulin mesylate|Given IV
12027893|NCT00383747|Drug|transdermal nicotine patch|14mg transdermal nicotine application
12027894|NCT00383747|Drug|Transdermal Nicotine Patch|14mg transdermal nicotine application
12027895|NCT00383734|Device|Newfill|1 to 7 injections of drug
12027896|NCT00383734|Device|Eutrophill|1 to 7 injections of drug
12027897|NCT00383721|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
12028247|NCT00381524|Behavioral|Increase condom use|Voluntary increase in condom use
12027898|NCT00383721|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
12027899|NCT00383721|Drug|Mometasone furoate MDI (MF MDI)|MF 400 mcg via metered dose inhaler twice daily for 52 weeks
12027900|NCT00383721|Drug|Formoterol MDI|Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
12027901|NCT00383721|Drug|Placebo|Placebo MDI twice a day for 26 weeks
12027902|NCT00383708|Drug|lanreotide (Autogel formulation)|120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.
12027903|NCT00383708|Drug|Pegvisomant|Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.
12027904|NCT00383695|Biological|cetuximab|
12027905|NCT00383695|Drug|capecitabine|
12027906|NCT00383695|Drug|oxaliplatin|
12027907|NCT00383695|Procedure|adjuvant therapy|
12027908|NCT00383695|Procedure|conventional surgery|
12027909|NCT00383695|Procedure|neoadjuvant therapy|
12027910|NCT00383695|Radiation|radiation therapy|
12027911|NCT00383682|Drug|morphine and mexiletine|
12027912|NCT00383669|Dietary Supplement|Multivitamins (including B, C and E)|One daily oral dose of 20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 μg B12, 0.8 mg folic acid, 500 mg C, and 30 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
12027913|NCT00383669|Dietary Supplement|Multivitamins B, C and E|One daily oral dose of 1.2 mg vitamin B1, 1.2 mg vitamin B2, 1.3 mg vitamin B6, 15 mg niacin, 2.4 μg vitamin B12, 0.4 mg folic acid, 80 mg vitamin C, and 15 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
12027914|NCT00383656|Drug|GnRH|75 ng/kg GnRH IV
12027915|NCT00383656|Device|Pump|portable, infusion pump for GnRH
12027916|NCT00383643|Drug|zolpidem tartrate|
12027917|NCT00383643|Drug|sodium oxybate|
12027918|NCT00383643|Drug|Matching Placebos|
12027919|NCT00383630|Biological|Intramyocardial injection of bone marrow mononuclear cells|6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
12027920|NCT00383630|Biological|Intramyocardial injection of CD34+ selected bone marrow mononuclear cells|6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
12027921|NCT00383630|Device|LVAD alone|LVAD implantation without any intramyocardial injection of bone marrow cells.
12027922|NCT00383591|Biological|Hepatitis B adjuvanted vaccine|
12027923|NCT00383591|Biological|Engerix-B|
12027924|NCT00383578|Drug|Vildagliptin 100 mg qd|
12027925|NCT00383578|Drug|Metformin 1500 mg daily|
12027926|NCT00383565|Drug|romidepsin|Given IV
12027927|NCT00383552|Drug|Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID|MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
12027928|NCT00383552|Drug|Mometasone Furoate MDI (MF MDI)|MF 100 mcg via metered dose inhaler twice daily for 26 weeks
12027929|NCT00383552|Drug|Formoterol Fumarate 10 mcg|F via metered dose inhaler 10 mcg twice a day for 26 weeks
12027930|NCT00383552|Drug|Placebo|Placebo metered dose inhaler twice a day for 26 weeks
12027931|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Vaccine Lot 1
12027932|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Vaccine Lot 2
12027933|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Vaccine Lot 3
12027934|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Control Vaccine
12027935|NCT00383526|Biological|Inactivated, split-virion influenza vaccine|Vaccine
12027936|NCT00383526|Biological|Inactivated, split-virion influenza vaccine|Vaccine
12027937|NCT00383513|Biological|Epratuzumab|360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour
12027938|NCT00383500|Device|Flexitouch|A standard of care intermittent pneumatic compression device (aka, lymphedema pump)
12027939|NCT00383500|Device|Class 1 compression garment|Manual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc).
12027940|NCT00383487|Drug|Calcitriol|0.5 micrograms/kilogram q weekly
12027941|NCT00383487|Drug|Naproxen-n-butyl nitrate|400 mg BID, oral
12027942|NCT00383474|Drug|Bortezomib|Given IV
12027943|NCT00383474|Other|Laboratory Biomarker Analysis|Correlative studies
12027944|NCT00383474|Drug|Tipifarnib|Given orally
12027945|NCT00383461|Behavioral|smoking cessation intervention|
12027946|NCT00383461|Other|counseling intervention|
12027947|NCT00383448|Drug|Clofarabine|days -7 through -3: 40 mg/m^2 intravenously over 2 hours
12027948|NCT00383448|Procedure|Total body Irradiation|Administration of TBI: The dose of TBI will be 200 cGy given in a single fraction on day -1. The dose rate will be between 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.
12027949|NCT00383448|Drug|Melphalan|day -2: 140 mg/m^2 intravenously over 30 minutes
12027950|NCT00383448|Biological|Hematopoietic Stem Cell Transplantation|receives infusion of stem cells on day 0
12027951|NCT00383448|Drug|Alemtuzumab|0.3 mg/kg intravenously (IV) days -12 through -8
12027952|NCT00383448|Drug|mycophenylate mofetil|Day -3 through Day 30: 1 gram three times daily (total daily dose 3 grams/day) if the recipient is >50 kg, or 15 mg/kg three times daily if the recipient is ≤50 kg. The same dosage is used orally or intravenously. Consider dose modification if renal impairment (GFR<25 mL/minute corrected)
12027953|NCT00383448|Device|Cyclosporine A|"Patients will receive CsA therapy beginning on day -3. Dosing of CsA will be 2.5 mg/kg/dose intravenously (IV); if the recipient body weight is <40 kg, dosing will be 3 times daily, and if > 40 kg twice daily. An attempt will be made to maintain a trough cyclosporine level of 250 mg/L to 350 mg/L. Once the patient can tolerate oral medications and has a normal gastrointestinal transit time, CsA will be converted to an oral form at a dose 2.5 x the current IV dose (maximum 12.5 mg/kg/day as initial oral dose).
~CsA taper begins at day +100."
12027954|NCT00383448|Drug|Hydroxyurea|hydroxyurea (HU) beginning day -28 and continuing through alemtuzumab administration
12027955|NCT00383435|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
12027956|NCT00383435|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
12027957|NCT00383435|Drug|Mometasone furoate MDI (MF MDI)|MF 400 mcg via metered dose inhaler twice daily for 52 weeks
12027958|NCT00383435|Drug|Formoterol MDI|Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
12027959|NCT00383435|Drug|Placebo|Placebo MDI twice a day for 26 weeks
12027960|NCT00383422|Drug|Arzoxifene|20 mg, oral, tablet, once a day for 52 weeks
12027961|NCT00383422|Drug|Raloxifene|60 mg, oral, tablet, once a day for 52 weeks
12027962|NCT00383409|Drug|multivitamins|
12027963|NCT00383409|Drug|placebo|
12027964|NCT00383396|Drug|Topical Cyclosporine|
12027965|NCT00383383|Biological|Hepatitis B adjuvanted vaccine|
12027966|NCT00383383|Biological|Engerix-B|
12027967|NCT00383370|Drug|VEGF Trap|VEGF Trap formulation 1, ITV-1
12027968|NCT00383370|Biological|VEGF Trap|VEGF Trap formulation 2 at higher concentration in Open label cohort
12027969|NCT00383357|Drug|zolpidem|
12027970|NCT00383344|Procedure|FDG PET/CT|
12027971|NCT00383331|Drug|Pemetrexed|"A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles
~B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles"
12027972|NCT00383331|Drug|Gemcitabine|"A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles
~B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles"
12027973|NCT00383318|Procedure|Gene mutation sample|
12027974|NCT00383305|Device|Cool-Cap|
12027975|NCT00383292|Drug|tasisulam|Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant discontinuation are met.
12027976|NCT00383279|Other|counseling intervention|
12027977|NCT00383279|Other|study of socioeconomic and demographic variables|
12027978|NCT00383266|Drug|Pemetrexed|
12027979|NCT00383266|Drug|Carboplatin|
12027980|NCT00383253|Behavioral|caloric restriction - 10%|Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
12027981|NCT00383253|Behavioral|caloric restriction - 25%|Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
12027982|NCT00383253|Behavioral|caloric restriction - 50%|Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
12027983|NCT00383253|Behavioral|caloric restriction - Control|Subjects maintained on their baseline caloric intake (caloric restriction = none)
12027984|NCT00383240|Drug|mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
12027985|NCT00383240|Drug|Mometasone furoate MDI (MF MDI) 200 mcg|MF 200 mcg via metered dose inhaler twice daily for 26 weeks
12027986|NCT00383240|Drug|formoterol fumarate 10 mcg|F via metered dose inhaler 10 mcg twice a day for 26 weeks
12027987|NCT00383240|Drug|Placebo|Placebo metered dose inhaler twice a day for 26 weeks
12027988|NCT00383227|Biological|Hepatitis B adjuvanted vaccine|
12027989|NCT00383214|Drug|Epratuzumab|360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
12027990|NCT00383214|Other|Placebo|Intravenous
12027991|NCT00383201|Device|OptiFree Multi-Purpose Disinfecting Solution|
12027992|NCT00383188|Drug|placebo|Capsule, once daily (QD) for 12 weeks
12027993|NCT00383188|Drug|PH-797804|Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks
12027994|NCT00383188|Drug|PH-797804|Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks
12027995|NCT00383188|Drug|PH-797804|Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks
12027996|NCT00383188|Drug|PH-797804|Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
12027997|NCT00383175|Other|Autorefractor, standard clinical instrument|Autorefractor, standard clinical instrument was used to assess the children's focusing power at near.
12027998|NCT00383162|Drug|Combination Product (sumatriptan succinate / naproxen sodium)|Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer.
12027999|NCT00383162|Drug|Placebo|Matching placebo tablet.
12028000|NCT00383149|Drug|Ixabepilone|Intravenous Infusion (IV), 32 mg/m^2 every 21 days.
12028001|NCT00383149|Drug|Cetuximab|Initial dose of 400 mg/m^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m^2 IV over 1 hour.
12028002|NCT00383136|Drug|tirofiban high-bolus dose regimen|bolus of 25 mcg/kg of body weight, followed by 18 hours infusion of 0.15 mcg/kg/min.
12028003|NCT00383136|Drug|Abciximab|bolus of 0.25 mg/kg of body weight, followed by 12 hours infusion of 0.125 mcg/kg per minute
12028004|NCT00383123|Biological|Fluarix™|"Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
~*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1."
12028005|NCT00383123|Biological|Fluzone|"Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
~*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1."
12028006|NCT00383097|Genetic|LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES|1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2
12028007|NCT00383097|Genetic|LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES|1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2
12028008|NCT00383084|Behavioral|Lifestyle physical activity (LPA)|Bi-weekly, 60-minute group sessions spread over 12 weeks. Participants will receive education on how to increase their daily physical activity, goal setting, problem solving strategies to overcome barriers to being more physically active, and finding new ways to integrate short bouts of LPA into their daily lives.
12028009|NCT00383084|Behavioral|Fibromyalgia education|Participants will meet monthly for 1.5 to 2 hours for a total of 3 months. The sessions will be divided into three components: (1) education, (2) question and answer, and (3) social support.
12028010|NCT00383071|Biological|H5N1 vaccine|Monovalent subvirion H5N1 vaccine (rgA/Vietnam/1203/2004) 90 mcg/mL Manufactured by Sanofi Pasteur Inc, Swiftwater, PA.
12028011|NCT00383071|Procedure|Apheresis|Once subjects achieved a high antibody titer (>1:160), they could begin apheresis to collect plasma.
12028012|NCT00383058|Drug|the extract of green tea|
12028013|NCT00383045|Drug|Buprenorphine/Subutex|
12028014|NCT00383045|Drug|Naltrexone|
12028015|NCT00383045|Procedure|Drug counseling|
12028016|NCT00383032|Drug|mifepristone|
12028017|NCT00383019|Drug|Xalacom (KP2035)|
12028018|NCT00383019|Drug|Xalatan|
12028019|NCT00383006|Behavioral|Skills for affect regulation (behavior)|
12028020|NCT00382993|Drug|Placebo|Matching placebo tablet
12028021|NCT00382993|Drug|Combination Product (sumatriptan succinate/naproxen sodium)|Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer.
12028022|NCT00382980|Biological|Aluminum hydroxide|Adjuvant administered with A/H5N1 vaccine dosages 7.5 mcg and 15 mcg.
12028023|NCT00382980|Biological|Inactivated Vero cell based whole virus influenza A/H5N1|Inactivated Vero cell-grown, whole virus, influenza A/H5N1 vaccine at dosages 7.5 mcg and 15 mcg of hemagglutinin (HA) per 0.5 mL, each dosage with and without aluminum hydroxide adjuvant; 45 mcg HA/0.5 mL without adjuvant.
12028024|NCT00382980|Drug|Placebo|Saline injected into the deltoid muscle. 2 identical dosages will be given approximately 28 days apart.
12028025|NCT00382967|Procedure|DaTSCAN SPECT imaging|A single intravenous injection of DaTSCAN with a total activity of 111-185 MBq (volume of 2.5 or 5.0 mL). SPECT scanning to be performed 3 to 6 hours after DaTSCAN injection.
12028026|NCT00382954|Drug|Velcade|velcade (4 original dosing levels with 3 modified dosing levels) I.V. on days 1, 4, 8, 11, 15, 18, 22, and 25 for 4 weeks concurrent with the Idarubicin
12028027|NCT00382954|Drug|Idarubicin|I.V., 8, or 10 or 12 mg/m^2 weekly (days 1, 8, 15, and 22) for 4 weeks
12028028|NCT00382941|Device|Red and near infrared LED phototherapy device|
12028029|NCT00382928|Device|Defibrillation of pulseless VT/VF by AECD|In case of cardiac arrest caused by shockable rhythms the automatic external cardioverter defibrillator (AECD) will automatically deliver defibrillation. Automated External Cardioverter Defibrillator (AECD; The PowerHeart CRM, Cardiac Science Inc., Seattle, WA) is a device attached to the chest wall by pads, monitors the electrocardiogram, and is capable of automatically delivering electric countershock to appropriate rhythms without operator intervention. The device will deliver only one shock of 150 Joules for pulseless ventricular tachycardia and ventricular fibrillation.
12028030|NCT00382915|Device|CReSSmicro handheld topography device|The CReSS micro device represents the state-of-the-art technology for measurements of ambulatory puff topography taken in the smoker's natural environment. Although all topography measurements are limited, at least to some degree, by the artificial act of smoking while using a device, or smoking through a mouthpiece, this small, lightweight and portable device is easy to use outside of the laboratory setting to capture more naturalistic smoking behavior and allows for less intrusion from the research team and research environment.
12028031|NCT00382902|Device|OptiFree Multi-Purpose Disinfecting Solution|
12028032|NCT00382889|Drug|beclomethasone/salbutamol combination|
12028033|NCT00382889|Drug|beclomethasone|
12028034|NCT00382889|Drug|salbutamol|
12028035|NCT00382863|Device|HeartNet Ventricular Support System|The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.
12028036|NCT00382863|Drug|Optimal Medical/Device Therapy|Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated.
12028037|NCT00382850|Procedure|Nissen fundoplication|
12028038|NCT00382837|Drug|Epratuzumab|
12028039|NCT00382824|Dietary Supplement|Coenzyme Q10|active drug
12028040|NCT00382824|Other|Placebo|Placebo
12028041|NCT00382811|Drug|phenoxodiol|400mg phenoxodiol three times daily in 28 day cycles.
12028042|NCT00382811|Drug|carboplatin|AUC=2 weekly in 28 day cycles
12028043|NCT00382811|Drug|placebo|every 8 hours daily in 28 day cycles
12028044|NCT00382798|Drug|RO5024048|
12028045|NCT00382785|Behavioral|moderated support|one 12-week online support group led by a professional healthcare provider
12028046|NCT00382785|Behavioral|peer-led|12-week online support in a peer-led format
12028047|NCT00382772|Biological|2-dose oral live attenuated G1P[8] human rotavirus vaccine|
12028048|NCT00382759|Procedure|stem cell transplant|
12028049|NCT00382746|Device|EarlySense monitoring device|
12028050|NCT00382733|Drug|Oral Topotecan|Topotecan will be received in one of the five dose levels:0.25mg/day,0.5mg/day, 0.75mg/day, 1.0mg/day, and 1.25mg/day.
12028051|NCT00382720|Drug|Docetaxel + Oxaliplatin|"Dose level 1 (non-optimal dose):
~Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1
~Dose level 2 (optimal dose):
~Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1"
12028052|NCT00382720|Drug|Docetaxel + Oxaliplatin + 5-FU|"Dose level 1 (non-optimal dose):
~Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1.
~Dose level 2 (optimal dose):
~Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1."
12028053|NCT00382720|Drug|Docetaxel + Oxaliplatin + Capecitabine|"Dose level 1 (optimal dose):
~Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously.
~Dose level 2 (non-optimal dose):
~Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously."
12028054|NCT00382707|Device|cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.|
12028055|NCT00382694|Drug|Fludarabine|
12028056|NCT00382681|Device|FID 107027 Multi-Purpose Disinfecting Solution|Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses.
12028057|NCT00382681|Device|ReNu MultiPlus Multi-Purpose Solution No Rub Formula|Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.
12028058|NCT00382668|Drug|Dasatinib|Tablets, Oral, 50 mg, once daily, for one day
12028059|NCT00382668|Drug|Dasatinib|Tablets, Oral, 20 mg, once daily for one day
12028060|NCT00382668|Drug|Dasatinib|Tablets, Oral, 70 mg, once daily for one day
12028061|NCT00382655|Procedure|Education and referral|
12028062|NCT00382642|Drug|Ondansetron + Cognitive Behavioral Therapy|13 week outpatient trial
12028063|NCT00382642|Drug|Placebo + Cognitive Behavioral Therapy|13 week outpatient trial
12028064|NCT00382629|Drug|BHT-3009 0.5 mg|
12028065|NCT00382629|Drug|BHT-3009 1.5 mg|
12028066|NCT00382629|Drug|Placebo|
12028067|NCT00382616|Drug|Phosphatidylserine-Omega3|
12028068|NCT00382603|Device|OptiFree Multi-Purpose Disinfecting Solution|
12028069|NCT00382590|Drug|5-Azacytidine|75 mg/m^2 daily for 7 days (days 1-7) via subcutaneous injection.
12028070|NCT00382590|Drug|Ara-C|20 mg twice daily via subcutaneous injection for 10 days.
12028071|NCT00382590|Drug|Valproic Acid (VPA)|50 mg/m^2 orally daily days 1-7.
12028072|NCT00382577|Drug|Itopride|
12028073|NCT00382577|Drug|Placebo|
12028074|NCT00382551|Behavioral|Moderate daily consumption of Red wine|
12028075|NCT00382551|Behavioral|Moderate daily consumption of beer|
12028076|NCT00382551|Behavioral|Moderate consumption of fruit juice rich in polyphenolics|
12028077|NCT00382538|Drug|Addition of mifepristone 200 mg 24 hours before induction|
12028078|NCT00382525|Device|Cardiac Rhythm Management device|
12028079|NCT00382512|Drug|Raptiva (efalizumab)|
12028080|NCT00382499|Drug|Lidocaine Intravenous Infusion|1.5 mg/kg IV bolus on induction, 3 mg/kg/hr infusion from inducation until fascia closure
12028081|NCT00382486|Procedure|Reduce the risk of allograft rejection|
12028082|NCT00382473|Behavioral|Aerobic exercise program - 8 weeks|No drugs. Regular aerobic exercise in structured prescription format
12028083|NCT00382460|Drug|PRAVASTATIN SODIUM|
12028084|NCT00382447|Device|standard nebulizer|Standard small volume nebulizer for aerosolized medication delivery
12028085|NCT00382447|Device|breath actuated nebulizer|Nebulizer that dispenses medication only during the inspiratory phase
12028086|NCT00382434|Procedure|presence of an emergency pharmacist in the ED|
12028087|NCT00382421|Drug|bisoprolol|
12028088|NCT00382421|Drug|amlodipine|
12028089|NCT00382421|Drug|molsidomine|
12028090|NCT00382421|Drug|acetylsalicylic acid|
12028091|NCT00382408|Biological|DR-5001|All randomized subjects received a single tablet of both Type-4 and Type-7 ADV vaccines on Day 0. Both vaccine tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.
12028092|NCT00382408|Other|Placebo|All randomized subjects received a single tablet each of the placebos matching Type-4 and Type-7 ADV vaccines on Day 0. Both placebo tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.
12028093|NCT00382395|Device|SOLX Gold Shunt GMS-plus|Single use implant
12028094|NCT00382395|Device|Ahmed FP7 Glaucoma Valve|Single use implant
12028095|NCT00382382|Other|diffusion tensor imaging (DTI)|Both groups will have a diffusion tensor imaging (DTI) perform.
12028096|NCT00382356|Drug|Dutasteride|once daily dosing of 0.5mg Dutasteride for 12 months
12028097|NCT00382343|Drug|Sulfamethoxazole/trimethoprim|Sulfamethoxazole/trimethoprim prophylaxis
12028098|NCT00382330|Drug|Ciclopirox|
12028099|NCT00382317|Drug|Iobitridol|
12028100|NCT00382304|Drug|tolevamer potassium-sodium (GT267-004)|
12028101|NCT00382291|Drug|Regular Titration|Sertraline will be administered in standard dosing. Treatment with sertraline will last 18 weeks.
12028102|NCT00382291|Drug|Placebo|The placebo will be administered in the same manner as sertraline. Treatment with placebo will last 18 weeks.
12028103|NCT00382291|Drug|Slow Titration|Sertraline will be administered in slow titration. Treatment with sertraline will last 18 weeks.
12028104|NCT00382278|Procedure|Autologous bone marrow-derived mononuclear cells infusion|Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. At least 100 millions of mononuclear-enriched BMC suspended in 20 mL of saline were delivered preferentially in the common hepatic artery by celiac trunk catheterism.
12028105|NCT00382265|Drug|tamsulosin|tamsulosin 0.4mg po qd for 28 days
12028106|NCT00382265|Other|Placebo|placebo po qd for 28 days
12028107|NCT00382252|Procedure|computed tomography|
12028108|NCT00382252|Procedure|positron emission tomography|
12028109|NCT00382252|Procedure|radiofrequency ablation|
12028110|NCT00382239|Drug|exenatide (LY2148568)|subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
12028111|NCT00382239|Drug|exenatide (LY2148568)|subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
12028112|NCT00382239|Drug|exenatide (LY2148568)|subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
12028113|NCT00382239|Drug|Placebo|subcutaneous injection twice daily, 0.02 mL to 0.04 mL
12028114|NCT00382226|Drug|Azopt|
12028115|NCT00382213|Drug|Olmesartan medoxomil|
12028116|NCT00382213|Drug|Placebo|
12028117|NCT00382200|Drug|decitabine|
12028118|NCT00382200|Drug|tretinoin|
12028119|NCT00382200|Genetic|DNA methylation analysis|
12028120|NCT00382200|Genetic|cytogenetic analysis|
12028121|NCT00382200|Genetic|microarray analysis|
12028122|NCT00382200|Other|flow cytometry|
12028123|NCT00382200|Other|immunohistochemistry staining method|
12028248|NCT00381511|Drug|low molecular weight heparin|
12028124|NCT00382187|Biological|MF59 adjuvanted H5N1 influenza vaccine|"MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
~non-adjuvanted influenza vaccine containing 15 ug of H5N1"
12028125|NCT00382174|Drug|Placebo|Topical administration of 0.00% thymosin beta 4 qd up to 84 days
12028126|NCT00382174|Drug|Thymosin Beta 4|Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
12028127|NCT00382161|Drug|Fluvastatin-sodium|
12028128|NCT00382148|Drug|omalizumab|SC repeating dose
12028129|NCT00382135|Drug|tadalafil|20mg tadalafil tablet taken by mouth once a day for 40 weeks
12028130|NCT00382135|Drug|placebo|Placebo tablet taken by mouth once a day for 40 weeks
12028131|NCT00382109|Drug|thiotepa|Given IV
12028132|NCT00382109|Drug|cyclophosphamide|Given IV
12028133|NCT00382109|Drug|tacrolimus|Given IV or orally
12028134|NCT00382109|Drug|methotrexate|Given IV
12028135|NCT00382109|Drug|sirolimus|Given orally
12028136|NCT00382109|Radiation|total body irradiation|Part of the transplant preparatory regimen
12028137|NCT00382096|Drug|Vildagliptin|
12028138|NCT00382096|Drug|Metformin|
12028139|NCT00382096|Drug|Vildagliptin + Metformin|
12028140|NCT00382083|Drug|1000 mg acetaminophen|
12028141|NCT00382083|Drug|800 mg ibuprofen|
12028142|NCT00382083|Drug|1 oz 4% lidocaine gel|
12028143|NCT00382070|Drug|Letrozole|Letrozole 2.5 mg taken orally once daily for 5 years
12028144|NCT00382070|Other|Placebo|Placebo tablet taken orally once daily for 5 years
12028145|NCT00382057|Drug|Testosterone|
12028146|NCT00382057|Drug|Anastrozole|
12028147|NCT00382057|Drug|Goserelin|
12028148|NCT00382044|Drug|Eprex; Neorecormon; Aranesp|
12028149|NCT00382031|Drug|Zalutumumab|Individual dose titration weekly i.v doses
12028150|NCT00382031|Other|Control|Best Supportive Care
12028151|NCT00382018|Drug|chemotherapy|No administration details available
12028152|NCT00381979|Other|Supportive Expressive Therapy|
12028153|NCT00381966|Device|robotic placement device|this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate.
12028154|NCT00381953|Drug|Peginterferon alfa-2a|
12028155|NCT00381953|Drug|Interferon alfa-2a|
12028156|NCT00381953|Drug|Ribavirin|
12028157|NCT00381940|Drug|ifosfamide|Given IV
12028158|NCT00381940|Drug|bortezomib|Given IV
12028159|NCT00381940|Drug|vinorelbine tartrate|Given IV
12028160|NCT00381940|Biological|filgrastim|Given IV or SC
12028161|NCT00381927|Behavioral|Physician Counseling|
12028162|NCT00381914|Drug|Vitamin D|400 IU vitamin D / day
12028163|NCT00381914|Drug|Vitamin D|800 IU vitamin D / day
12028164|NCT00381914|Drug|Vitamin D|1200 IU vitamin D / day
12028165|NCT00381901|Biological|trastuzumab|
12028166|NCT00381901|Genetic|polymorphism analysis|
12028167|NCT00381901|Procedure|adjuvant therapy|
12028168|NCT00381888|Drug|fondaparinux sodium|Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
12028169|NCT00381875|Biological|E1M184V peptide vaccine|
12028170|NCT00381875|Biological|incomplete Freund's adjuvant|
12028171|NCT00381875|Biological|sargramostim|
12028172|NCT00381875|Other|immunoenzyme technique|
12028173|NCT00381862|Drug|aprepitant|Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
12028174|NCT00381862|Drug|dexamethasone|Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
12028175|NCT00381862|Drug|fluorouracil|as per institutional standard of care
12028176|NCT00381862|Drug|irinotecan hydrochloride|as per institutional standard of care
12028177|NCT00381862|Drug|leucovorin calcium|as per institutional standard of care
12028178|NCT00381862|Drug|oxaliplatin|as per institutional standard of care
12028179|NCT00381862|Drug|palonosetron hydrochloride|Palonosetron 0.25 mg IV push on day 1 only.
12028180|NCT00381862|Procedure|quality-of-life assessment|baseline
12028181|NCT00381849|Drug|Cystone|"Participants will take 2 pills, 2 times a day.
~Each tablet of Cystone contains:
~Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg."
12028182|NCT00381849|Drug|Sugar Pill (Placebo)|Participants will take 2 pills, 2 times a day for 6 weeks.
12028183|NCT00381836|Drug|Darbepoetin Alfa|
12028184|NCT00381823|Behavioral|Cognitive Behavioral Therapy|
12028185|NCT00381810|Drug|Rituximab|Rituximab will be supplied as a liquid for intravenous infusion.
12028186|NCT00381810|Drug|Methylprednisolone|
12028187|NCT00381810|Drug|Acetaminophen|
12028188|NCT00381810|Drug|Diphenhydramine|
12028189|NCT00381797|Biological|Bevacizumab|Given IV
12028190|NCT00381797|Radiation|Fludeoxyglucose F-18|Undergo fludeoxyglucose F18 PET
12028191|NCT00381797|Drug|Irinotecan Hydrochloride|Given IV
12028192|NCT00381784|Behavioral|Printed materials|"Role model stories comprise the heart of printed materials distributed throughout the target community. The role model stories are brief publications that depict personal accounts from individuals in the population of focus who have made or are planning to make a risk-reducing behavioral change. Depending on the population they are meant to reach and what behavior they are trying to influence, the stories may include examples of people who now carry condoms with them, talked to a partner about condom use, use condoms consistently, avoid sharing needles, or exhibited other risk reduction behaviors."
12028249|NCT00381485|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
12028250|NCT00381485|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
12028251|NCT00381485|Drug|Mometasone furoate MDI (MF MDI)|MF 400 mcg via metered dose inhaler twice daily for 12 weeks
12028252|NCT00381472|Drug|Ropinirole|
12028193|NCT00381784|Behavioral|Peer advocates|"Core Element 1 Core group of young gay men and additional volunteers recruited from the community. The core group and volunteers comprise the peer advocates who design and carry out all program activities.
~Core Element 2 Designated space where most social events and meetings are held; also serves as a drop in center where young men can meet and socialize during specified hours.
~Core Element 3 Social events to attract young gay men and to promote safer sex. Core Element 4 Teams of young gay men go to locations frequented by young gay men to discuss and promote safer sex, deliver appealing informational literature on HIV risk reduction and distribute condoms.
~Core Element 5 Meetings of eight to 10 young gay men to discuss factors contributing to unsafe sex among men. Men practice safer sex negotiation and correct condom use skills.
~Core Element 6 Publicity campaigns that attract men to the program by word of mouth and through articles and advertisements in gay newspapers."
12028194|NCT00381771|Behavioral|Conservative management for xerostomia|Active hydration (drinking more than 10 cups of water per day), Humidification, Oral gargle with a diluted (0.05% to 0.1%) chlorhexidine solution, Sugarless chewing gum, Saliva-stimulating sour juice (sugarless orange juice), Commercial artificial saliva, Nasal saline spray 3 to 4 times a day, Warm massage of the 4 major salivary glands.
12028195|NCT00381758|Drug|Methylphenidate Extended Release Capsules|
12028196|NCT00381732|Drug|tadalafil|2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
12028197|NCT00381732|Drug|placebo|Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.
12028198|NCT00381719|Drug|AGN 203818|3 mg Capsule twice daily for 4 weeks
12028199|NCT00381719|Drug|AGN 203818|20 mg Capsule twice daily for 4 weeks
12028200|NCT00381719|Drug|AGN 203818|60 mg Capsule twice daily for 4 weeks
12028201|NCT00381719|Drug|placebo capsule|Capsule twice daily for 4 weeks
12028202|NCT00381706|Biological|cetuximab|given IV
12028203|NCT00381706|Drug|ECF|epirubicin and 5-fluorouracil given IV
12028204|NCT00381706|Drug|IC|cisplatin and irinotecan given IV
12028205|NCT00381706|Drug|FOLFOX|oxaliplatin , leucovorin and 5-fluorouracil IV
12028206|NCT00381693|Drug|azacitidine|
12028207|NCT00381680|Drug|vincristine sulfate|Given IV
12028208|NCT00381680|Drug|prednisone|Given PO
12028209|NCT00381680|Drug|doxorubicin hydrochloride|Given IV
12028210|NCT00381680|Drug|pegaspargase|Given IM
12028211|NCT00381680|Drug|cytarabine|Given IT or IV
12028212|NCT00381680|Drug|methotrexate|Given IT or IV
12028213|NCT00381680|Drug|dexamethasone|Given PO
12028214|NCT00381680|Drug|etoposide|Given IV
12028215|NCT00381680|Drug|cyclophosphamide|Given IV
12028216|NCT00381680|Drug|leucovorin calcium|Given IV or PO
12028217|NCT00381680|Biological|filgrastim|Given IV or SC
12028218|NCT00381680|Drug|asparaginase|Given IM
12028219|NCT00381680|Drug|mercaptopurine|Given PO
12028220|NCT00381667|Drug|GW642444M|M salt
12028221|NCT00381667|Drug|GW642444H|H salt
12028222|NCT00381667|Other|placebo|placebo
12028223|NCT00381654|Drug|AV-412|Solid oral dosage; 4 dosage strengths; 25, 50, 100, or 200 mg per capsule Dosing Frequency: Once daily dosing for 4 weeks (4 weeks equals 1 cycle)
12028224|NCT00381641|Other|Laboratory Biomarker Analysis|Optional correlative studies
12028225|NCT00381641|Other|Pharmacogenomic Study|Optional correlative studies
12028226|NCT00381641|Drug|Sunitinib|Given PO
12028227|NCT00381641|Drug|Sunitinib Malate|Given PO
12028228|NCT00381628|Procedure|epithelial cells and blood lymphocyte extraction|Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.
12028229|NCT00381615|Biological|rMenB|One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
12028230|NCT00381615|Biological|rMenB+OMV|One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
12028231|NCT00381615|Biological|DTaP-Hib-IPV|Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
12028232|NCT00381615|Biological|PC7|IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
12028233|NCT00381615|Biological|MenC-CRM|MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.
12028234|NCT00381615|Biological|MenC-Hib|MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.
12028235|NCT00381615|Biological|MMR|IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh.
12028236|NCT00381602|Drug|GHRP-1/AG 70 mg depot in ESRD|
12028237|NCT00381602|Other|Placebo|
12028238|NCT00381589|Drug|ipratropium bromide 0.03% spray|
12028239|NCT00381576|Behavioral|Resistance training|Intervention group: 12 weeks of resistance training for the lower extremity. Control group: No intervention - 12 weeks of normal daily living
12028240|NCT00381563|Device|Patellofemoral realigning knee brace|Knee brace that changes the tracking of the patella over the femur bone
12028241|NCT00381563|Device|Non-aligning knee brace|Knee brace that does not change the tracking of the patella over the femur bone
12028242|NCT00381550|Drug|fludarabine phosphate|Given IV
12028243|NCT00381550|Drug|triapine|Given IV
12028244|NCT00381550|Procedure|laboratory biomarker analysis|Correlative study
12028245|NCT00381537|Drug|phenobarbitone|
12028255|NCT00381420|Device|drug-eluting stent|sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
12028256|NCT00381420|Device|bare-metal stent|un-coated Bx VELOCITY Stent
12028257|NCT00381407|Behavioral|Organizational Skills Training|Participants in the OST group attend twenty 1-hour sessions over 10 weeks. OST trains children to use a variety of techniques for improving their organizational skills. Both children and their parents attend every OST session.
12028258|NCT00381407|Behavioral|Contingency management (CM)|"Participants in the CM group will attend twenty 1-hour sessions over 10 weeks. CM trains parents and teachers to identify desired end behaviors and to increase the frequency of these behaviors through the use of a structured reward system. Both children and their parents attend every CM session, but the children's participation will be minimal."
12028259|NCT00381394|Drug|sitamaquine|
12028260|NCT00381381|Drug|Donepezil|2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.
12028261|NCT00381368|Drug|Ibandronic acid|
12028262|NCT00381355|Procedure|Written Action Plan for Acute Asthma|
12028263|NCT00381342|Drug|exenatide|Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
12028264|NCT00381342|Drug|exenatide|Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
12028265|NCT00381342|Drug|placebo|subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
12028266|NCT00381329|Behavioral|Motivational Interviewing (MI)|MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.
12028267|NCT00381329|Behavioral|Structured Brief Advice (SBA)|SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.
12028268|NCT00381316|Drug|Technetium Tc99m Tetrofosmin injections|Single Isotope: be 555 to 888 MBq (15 to 24 mCi) MYOVIEW at Rest/i.v./bolus.
12028269|NCT00381316|Drug|Thallous Chloride T1-201|Myoview SPECT Imaging
12028270|NCT00381303|Drug|darunavir|600mg bid for 48 wks
12028271|NCT00381303|Drug|ritonavir|100mg bid for 48 wks
12028272|NCT00381290|Behavioral|Diet|The prescribed diet will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day.
12028273|NCT00381290|Behavioral|Exercise|The program will consist of 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home.
12028274|NCT00381277|Drug|Gatorade|
12028275|NCT00381277|Drug|Performance|
12028276|NCT00381264|Drug|Cesamet™ (nabilone)|
12028277|NCT00381251|Drug|Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg|
12028278|NCT00381238|Drug|rosiglitazone|Extended Release Tablets
12028279|NCT00381225|Procedure|Ultra-sound guided radio-frequency ablation|
12028280|NCT00381212|Biological|AGS-004|Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.
12028281|NCT00381199|Drug|Amitriptyline Hydrochloride|
12028282|NCT00381199|Drug|Nabilone|
12028283|NCT00381186|Behavioral|diet- and exercise intervention|
12028284|NCT00381173|Drug|Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)|Patients who meet all entry criteria will be administered 600 mg/m^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).
12028285|NCT00381160|Behavioral|Reduction of sugar-sweetened beverage consumption|Multi-component intervention aimed at reducing sugar-sweetened beverage consumption. Components include delivery of non-caloric beverages to home in combination with behavioral modification (telephone counseling with parent; check in visit with participant).
12028286|NCT00381147|Drug|Clarithromycin|
12028287|NCT00381134|Drug|losartan 100 mg orally once daily|
12028288|NCT00381134|Drug|spironolactone 25 mg orally once daily|
12028289|NCT00381134|Drug|placebo once orally once daily|
12028290|NCT00381108|Drug|Placebo Tablet|Two tablets, twice daily.
12028291|NCT00381108|Drug|Pomegranate Tablet|Two tablets, twice daily.
12028292|NCT00381095|Drug|Pregabalin|Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
12028293|NCT00381095|Drug|Placebo|Placebo
12028294|NCT00381082|Drug|1) MOOV Head Lice Treatment (Ego Pharmaceutical).|
12028295|NCT00381082|Drug|Banlice Mousse Aerosol (Pfizer, Australia)|
12028296|NCT00381082|Drug|3) KP24 Medicated Foam (Nelson Laboratories)|
12028297|NCT00381069|Behavioral|Family & Community Recreation Center Intervention|The two year intervention involves changing the environment and policies in community recreation centers to promote physical activity and healthy eating choices. The Recreation Specialist will meet with recreation center staff monthly to create action plans that work towards this goal. Family Health Coaches will be in contact with intervention families twice a month either through a phone consultation, workshop at the recreation center,or home visit. Intervention families will receive a monthly mailing highlighting tips for healthy eating and physical activity. MOVE families will be encouraged to utilize the recreation center as a resource in supporting their child's physical activity and healthy eating behaviors.
12028298|NCT00381056|Behavioral|Labor and Delivery Team Coordination Course|
12028299|NCT00381043|Drug|Acamprosate (Campral)|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
12028300|NCT00381030|Drug|carvedilol plus nurse management|
12028301|NCT00381017|Drug|Peg interferon alpha-2b|
12028302|NCT00381004|Drug|Cyclophosphamide|Course 1: 250 mg/m^2 by vein over 5-30 minutes on Days 2, 3, and 4; Course 2 - 6: 250 mg/m^2 by vein over 5-30 minutes on Days 1 - 3
12028303|NCT00381004|Drug|Fludarabine|Course 1: 25 mg/m^2 by vein over 5-30 minutes on Days 2,3, and 4; Course 2 - 6: 25 mg/m^2 by vein over 5-30 minutes on Days 1 - 3
12028357|NCT00380484|Drug|Montelukast|5 mg daily
12028304|NCT00381004|Drug|Sargramostim|Course 1: 250 mcg/m^2 subcutaneous (SQ) on Days -1 and Days 5 - 11; Course 2 - 6: 250 mcg/m^2 SQ on Days -1 and Days 4 - 10
12028305|NCT00381004|Drug|Rituximab|Course 1: 375 mg/m^2 by vein over 2-6 Hours on Day 1; Course 2 - 6: 500 mg/m^2 by vein over 2-6 Hours on Day 1
12028306|NCT00380991|Drug|lactoserum|
12028307|NCT00380978|Procedure|combined spinal epidural analgesia|Analgesia was initiated in the early group using a standard needle-through-needle technique with intrathecal fentanyl 25 mcg and an epidural test dose of lidocaine 15 mg/ml and epinephrine 5 mcg/ml in 3ml. At the second analgesia request, the cervix was examined. Epidural analgesia was initiated with a dilute bupivicaine/fentanyl solution if the cervix was less than 4 cm. If the cervix was 4 cm or more, epidural analgesia was initiated with bupivicaine 1.25 mg/ml. If no cervical exam was performed at the second request for analgesia, the cervix was assumed to be at least 4 cm dilated. Thereafter, analgesia was maintained in all participants in the early group with patient-controlled epidural analgesia.
12028308|NCT00380978|Procedure|late analgesia (systemic)|Analgesia was initiated in the late group with hydromorphone 1mg intramuscularly (IM) and 1 mg intravenously (IV). If the cervix was less than 4 cm at the second analgesia request, hydromorphone analgesia was repeated. Epidural analgesia was initiated with bupivicaine 1.25 mg/ml if the cervix was 4 cm or more. At the third analgesia request, epidural analgesia was initiated regardless of cervical dilation. Thereafter, epidural analgesia was maintained with patient controlled analgesia until delivery.
12028309|NCT00380965|Drug|Cesamet™ (nabilone)|
12028310|NCT00380952|Device|Dune Device|
12028311|NCT00380939|Drug|Atorvastatin|
12028312|NCT00380939|Drug|Pravastatin|
12028313|NCT00380926|Drug|polyunsatturated fatty acids (fish oil)|
12028314|NCT00380913|Drug|Cesamet™ (nabilone)|
12028315|NCT00380900|Drug|AGG-523|
12028316|NCT00380887|Drug|Premarin|
12028317|NCT00380874|Drug|Pregabalin|150- 600 mg/day (double blind in divided doses)
12028318|NCT00380874|Drug|Placebo|Placebo
12028319|NCT00380861|Device|Total knee replacement using the PFC Sigma RPF knee implant.|Total knee replacement
12028320|NCT00380861|Device|Total knee replacement using the PFC Sigma RP knee implant|Total knee replacement
12028321|NCT00380848|Procedure|Hemodiafiltration|
12028322|NCT00380835|Drug|Amrubicin|
12028323|NCT00380822|Drug|miglitol|
12028324|NCT00380809|Procedure|Rotational Atherectomy + PES|
12028325|NCT00380809|Procedure|Standard Treatment (PES without Rotational Atherectomy)|
12028326|NCT00380796|Drug|Collection of safety data for Cohort 1|Twice-yearly collection of information about cancer incidence and cause of death among patients who participated in clinical trials of infliximab in the treatment of COPD. The follow-up period is 5 years.
12028327|NCT00380783|Drug|AGN 203818|
12028328|NCT00380770|Drug|Generic HAART Triomune : d4T, 3TC, NVP|Triomune® (Cipla, Mumbai) Stavudine 40mg b.d > 60 kg , 30mg bd <60kg Lamivudine 150mg b.d > 50 kg 2mg/kg < 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)
12028329|NCT00380770|Drug|Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV|Triomune® (Cipla, Mumbai) Stavudine 40mg b.d > 60 kg , 30mg bd <60kg Lamivudine 150mg b.d > 50 kg 2mg/kg < 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks) Intramuscular Bleomycin 10 U/m2 ; Intravenous Vincristine 1.4mg/m2 maximum 2mg and Intravenous Doxorubicin 20mg/m2.
12028330|NCT00380757|Procedure|bystander CPR using 30:2 ratio vs 15:2 ratio|Participants will use 2 CPR techniques with different chest compression to ventilation ratios
12028331|NCT00380744|Drug|LY2189102|
12028332|NCT00380744|Drug|placebo|
12028333|NCT00380731|Behavioral|Individual Cognitive Behavioral Therapy|CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.
12028334|NCT00380718|Drug|pemetrexed|"500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease.
~*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets <50 x 10^9/L; absolute neutrophil count <1.0 x 10^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade >2; Skin Grade >2; Serum bilirubin >3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase >10 x ULN; Other non-hematologic toxicities Grade >2 (except nausea, vomiting)."
12028335|NCT00380705|Drug|MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks|
12028336|NCT00380692|Drug|Atomoxetine|
12028337|NCT00380692|Drug|Placebo|
12028338|NCT00380679|Biological|Influenza vaccination|
12028339|NCT00380679|Biological|Pneumococcal polysaccharide vaccination|
12028340|NCT00380666|Procedure|PET/CT scan|
12028341|NCT00380653|Drug|sapacitabine|
12028342|NCT00380640|Drug|Trimethoprim|This group will receive the active intervention (trimethoprim) first, followed by the placebo.
12028343|NCT00380640|Drug|Trimethoprim|This group will start the study with placebo, followed by the active intervention (trimethoprim).
12028344|NCT00380627|Drug|MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days|
12028345|NCT00380614|Drug|Lamivudine|
12028346|NCT00380601|Drug|MRA(Tocilizumab)|8mg/kg/4 weeks
12028347|NCT00380588|Drug|gemcitabine|1000 milligrams per square meter (mg/m2), intravenous (IV)
12028348|NCT00380588|Drug|cisplatin|25 milligrams per square meter (mg/m2), intravenous (IV)
12028349|NCT00380575|Drug|YM087|
12028350|NCT00380562|Behavioral|Experience Corps|High intensity volunteering (15 hours a week or more) over a two year time period working with children in grades K-3 in Baltimore City Schools. Controls are assigned to usual activities for two years and then offered opportunity to volunteer with children at the end of two year.
12028351|NCT00380549|Diagnostic Test|Blood ion levels|Blood ion levels or the levels of cobalt and chromium ions in the blood and urine will be analyzed.
12028352|NCT00380536|Behavioral|Peer-Led Health Education Class|Participants will participate in group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.
12028353|NCT00380523|Drug|MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days|
12028354|NCT00380497|Drug|PEG-Lyte®|
12028355|NCT00380497|Drug|Pico-Salax®|
12028356|NCT00380484|Drug|Budesonide|200µg daily
12028359|NCT00380458|Device|Coblation (radiofrequency-based device)|
12028360|NCT00380445|Drug|Vildagliptin|
12028361|NCT00380419|Behavioral|Interpersonal Psychotherapy (IPT)|IPT sessions will address adjustment to pregnancy, concerns about interpersonal relationships, and parenting concerns. Sessions will be weekly, but may be determined by clinical desires of patient and therapist.
12028362|NCT00380406|Drug|Leuprolide acetate|
12028363|NCT00380393|Biological|GSK malaria vaccine 257049 Vaccine|3 dose intramuscular injection
12028364|NCT00380393|Biological|Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine|3 dose intramuscular injection
12028365|NCT00380380|Drug|Vildagliptin|
12028366|NCT00380367|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.
12028367|NCT00380354|Drug|GSK256066|
12028368|NCT00380341|Procedure|Instrument-applied spinal manipulative therapy|
12028369|NCT00380328|Drug|neratinib|HKI-272
12028370|NCT00380315|Drug|AG1321001(drug)|
12028371|NCT00380302|Drug|AVE1625|
12028372|NCT00380289|Drug|Thiazide and beta blocker|
12028373|NCT00380276|Drug|MPC-7869|800 mg BID Oral dosing
12028374|NCT00380263|Drug|PACAP38|10 pmol/kg/min given one time
12028375|NCT00380250|Drug|Lubiprostone|
12028376|NCT00380250|Drug|Placebo|
12028377|NCT00380237|Biological|H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)|Live attenuated H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine
12028378|NCT00380224|Drug|bifeprunox, olanzapine|
12028379|NCT00380211|Biological|Influenza vaccine (A/H3N2, A/H1N1, and B strains)|
12028380|NCT00380211|Biological|Fluarix|
12028381|NCT00380198|Drug|Apadenoson|
12028382|NCT00380172|Device|Rheopheresis blood filtration|
12028383|NCT00380159|Drug|elvucitabine|elvucitabine 10 mg in combination with background ART
12028384|NCT00380159|Drug|Lamivudine|
12028385|NCT00380159|Drug|Emtricitabine|
12028386|NCT00380146|Drug|sulfadoxine-pyrimethamine|
12028387|NCT00380133|Drug|SB681323|5 mg and 2.5 mg tablets - The tablets will be round (9.0 mm in diameter) and white and provided in labelled bottles
12028388|NCT00380133|Drug|Prednisolone|5 mg size DB AA capsule shell (Swedish orange) with a powder backfill (lactose Anhydrous)
12028389|NCT00380133|Drug|Placebo|Tablets matched to SB681323 or prednisolone
12028390|NCT00380120|Drug|sodium warfarin|dosage: as much as it is required to prolong the international normalized ratio, checked every 2-3 weeks, between 2.0 and 3.0
12028391|NCT00380120|Drug|Sodium warfarin|As much drug as it is necessary to prolong the international normalized ratio between 2.0 and 3.0
12028392|NCT00380081|Drug|zolpidem tartrate sublingual tablet 3.5mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
12028393|NCT00380081|Drug|zolpidem tartrate sublingual tablet 1.75mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
12028394|NCT00380081|Drug|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
12028395|NCT00380068|Drug|Ambrisentan|Oral tablets taken once daily.
12028396|NCT00380055|Behavioral|Navigation Services|Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.
12028397|NCT00380055|Behavioral|Cancer education|Community health workers provide cancer education appropriate for Medicare participants.
12028398|NCT00380042|Device|Cortical Stimulation|Cortical stimulation of prefrontal cortex
12028399|NCT00380042|Device|Sham|Sham stimulation
12028400|NCT00380029|Drug|Erlotinib|Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
12028401|NCT00380029|Procedure|Radical Cystectomy|Will occur 4 weeks prior to dosing with erlotinib
12028402|NCT00380016|Procedure|Percutaneous Transluminal Angioplasty|
12028403|NCT00380003|Drug|EVT 201|
12028404|NCT00379990|Drug|GW274150|60 mg /day
12028405|NCT00379990|Drug|Prednisolone|7.5 mg/day
12028406|NCT00379990|Other|Placebo|Placebo
12028407|NCT00379977|Biological|diphtheria, tetanus, pertussis & Hib vaccine|
12028408|NCT00379964|Drug|caspofungin acetate|Cancidas 50 mg dose followed by 70 mg load on day 1 was administered in Indian adults with persistent fever and neutropenia for a maximum duration of empirical treatment from 28 days ((for patients without documented infection) to 90 days (for patients with documented baseline or emergent fungal infection). Patients were treated until the resolution of neutropenia (ANC>500/mm3), and for up to 72 hours later.
12028409|NCT00379951|Drug|ertapenem sodium|ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.
12028410|NCT00379938|Biological|VAI-VP705 (parvovirus B-19 vaccine)|Recombinant human parvovirus B-19 capsids at dose levels: 25 micrograms of VAI-VP705 with and without MF59 adjuvant and 2.5 micrograms with MF59 adjuvant.
12028411|NCT00379938|Drug|Placebo|Saline control
12028412|NCT00379938|Biological|MF-59|Adjuvant
12028413|NCT00379925|Behavioral|Physical Activity and Dietary Health Promotion Program|Churches within the intervention group will receive a committee training and church cook training designed to teach them how to do a self-assessment of current practices and develop a plan for their program. The intervention is based on the structural model of health behavior and targets opportunities, mass media (within the church), guidelines and policies, and church environment. Intervention churches also receive monthly intervention mailings to support intervention implementation.
12028414|NCT00379912|Drug|Azacitidine|Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
12028415|NCT00379912|Drug|Erythropoietin|Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
12028416|NCT00379912|Drug|Azacitidine (Monotherapy)|Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
12028417|NCT00379899|Drug|cinacalcet|Low dose vitamin D with cinacalcet
12028418|NCT00379886|Drug|Propofol Thiopental|
12028419|NCT00379873|Device|ProAdjuster|
12028420|NCT00379860|Drug|LXR-623|
12028421|NCT00379847|Drug|conivaptan|IV
12028422|NCT00379834|Drug|Cosopt|Cosopt twice daily in both eyes
12028423|NCT00379821|Drug|Atovaquone-proguanil|Atovaquone-proguanil: once a day for 3 days, Pediatric tablet: 62.5 mg/25 mg, Full strength tablet: 250 mg/100 mg
12028424|NCT00379821|Drug|Artesunate|Artesunate: 4mg/kg once a day for 3 days, 50 mg tablet
12028425|NCT00379821|Drug|Azithromycin|Azithromycin 30 mg/kg once a day for 3 days, 200 mg/5cc suspension
12028426|NCT00379821|Drug|Chloroquine|Chloroquine: 10 mg/kg on days 0 and 1, 5 mg/kg/day on day 2, 100 mg tablet.
12028427|NCT00379808|Drug|montelukast|10 mg tablet (masked by capsule) daily for 1 month
12028428|NCT00379808|Drug|Placebo|1 lactose-containing capsule daily for 1 month
12028429|NCT00379795|Drug|Ranibizumab 0.5 mg|Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)
12028430|NCT00379782|Other|Navigation|Navigation and escourt
12028431|NCT00379769|Drug|Rosiglitazone|Rosiglitazone maximum 8 mg per day
12028432|NCT00379769|Drug|Sulfonylurea|Sulfonylurea (SU) maximum permitted daily dose
12028433|NCT00379769|Drug|Metformin|Metformin maximum permitted daily dose .
12028434|NCT00379756|Drug|LEVITRA (vardenafil)|active comparator
12028435|NCT00379756|Drug|placebo|placebo comparator
12028436|NCT00379743|Behavioral|Health coordinator (or patient navigator)|Individuals randomized to receive the less intensive intervention receive educational materials only. Those randomized to the more intensive intervention are assigned a health coordinator (patient navigator) who delivers an enhanced, tailored educational intervention after review of the participant's screening history and knowledge gaps about cancer. The health coordinator also facilitate adherence to cancer screening and/or treatment services, by assisting in scheduling and keeping of appointments for cancer-related screening and/or treatment services.
12028437|NCT00379743|Behavioral|Educational materials only|A brochure is provided to the participant with information about preventive services covered by Medicare, and the frequency with which those services should be obtained.
12028438|NCT00379730|Drug|Prednisolone|
12028439|NCT00379717|Drug|Cisplatinum|
12028440|NCT00379717|Drug|Docetaxel|
12028441|NCT00379717|Device|Tomotherapy|
12028442|NCT00379691|Drug|phenylephrine|
12028443|NCT00379665|Drug|Cisplatin|1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
12028444|NCT00379652|Behavioral|Medical Practice Improvement|The details for the medical practice improvement intervention will be decided at a later date.
12028445|NCT00379652|Behavioral|Patient Education and Support|The details for the patient education and support intervention will be decided at a later date.
12028446|NCT00379652|Other|Combination Intervention to Include Medical Practice Improvement and Patient Education and Support|The details for this combination intervention will be decided at a later date.
12028447|NCT00379639|Drug|Romidepsin|7, 10 or 12 mg/m^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle.
12028448|NCT00379639|Drug|Gemcitabine|800 or 1000 mg/m^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle.
12028449|NCT00379626|Drug|cognitive and hormone treatment|cognitive and hormone (Leuprorelin) treatment
12028450|NCT00379613|Drug|sugammadex|"After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)
~At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered"
12028451|NCT00379613|Drug|Placebo|"After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)
~At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered"
12028452|NCT00379600|Drug|rosiglitazone XR|
12028453|NCT00379587|Drug|Rituximab|Rituximab at months 3, 6, 9 and 12 post-transplant
12028454|NCT00379587|Drug|375 mg/m2 RRituximab|Rituximab 375 mg/m2 q3months
12028455|NCT00379574|Drug|Bortezomib|"Bortezomib:
~For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.
~For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks."
12028456|NCT00379574|Drug|Cyclophosphamide|cyclophosphamide 750mg/m2 day 1, every 2 weeks
12028457|NCT00379574|Drug|Doxorubicin|doxorubicin 50 mg/m2 day 1, every 2 weeks
12028458|NCT00379574|Drug|Vincristine|vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks
12028459|NCT00379574|Drug|Prednisolone|prednisolone 100 mg days 1-5, every 2 weeks
12028460|NCT00379574|Drug|Lenograstim|Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks
12028461|NCT00379561|Drug|PSA-Activated PSA-PAH1|
12028462|NCT00379548|Behavioral|2 groups of population responding to 2 types of diets|Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.
12028463|NCT00379535|Drug|potassium iodide|per os
12028464|NCT00379535|Drug|placebo|per os
12028465|NCT00379522|Drug|Vasopressin|10 minutes after standard shock treatment 10 IU arginine vasopressin will be injected; if shock persists for 5 minutes, another 10 IU arginine vasopressin will be injected; after 5 minutes persisting shock, the last 10 IU arginine vasopressin will be injected; Total duration: approx. 15 minutes; Dose per intravenous injection: 10 IU; max. dose: 30 IU arginine vasopressin
12028466|NCT00379522|Drug|Saline placebo|Placebo for arginine vasopressin
12028467|NCT00379509|Drug|lapatinib ditosylate|Patients will be assigned in cohorts of 3. Dose levels of GW572106 will include 500mg, 1000mg,1500 mg (additional levels at 750 mg and 1250 mg will be added if needed). Lapatinib is an oral drug. It is taken every day.
12028468|NCT00379509|Genetic|TdT-mediated dUTP nick end labeling assay|Genetic analysis of tumor tissue
12028469|NCT00379509|Genetic|gene expression analysis|Genetic analysis of tumor tissue.
12028470|NCT00379509|Genetic|microarray analysis|Genetic analysis of tumor tissue.
12028471|NCT00379509|Other|immunohistochemistry staining method|Laboratory analysis of tumor tissue.
12028472|NCT00379509|Procedure|biopsy|Serial biopsies by skin punch or core biopsy or fine needle aspiration.
12028473|NCT00379509|Radiation|radiation therapy|Radiotherapy will be delivered at standard dose and fractionation. For patients who have not received previous locoregional radiotherapy, 50-56 Gy will be delivered to the regional lymph nodes and/or chest wall at a dose of 2 Gy per fraction, 5 days per week followed by a boost to the sites of gross involvement to a total dose of 60-70 Gy over a course of 6-7 weeks. For patients who have received adjuvant radiotherapy, a dose of 35-45 Gy will be delivered to sites of chest wall involvement at a dose of 1.8 Gy per fraction over 4-5 weeks. In either de novo or reirradiated settings, the total dose to the brachial plexus will not exceed 60 Gy.
12028474|NCT00379496|Procedure|Antidepressants|
12028475|NCT00379496|Procedure|acupuncture|
12028476|NCT00379483|Drug|Deferasirox|
12028477|NCT00379470|Device|NovoTTF-100A|multiple four-week courses of continuous NovoTTF-100A treatment
12028478|NCT00379457|Biological|dactinomycin|
12028479|NCT00379457|Drug|carboplatin|
12028480|NCT00379457|Drug|cyclophosphamide|
12028481|NCT00379457|Drug|doxorubicin hydrochloride|
12028482|NCT00379457|Drug|etoposide|
12028483|NCT00379457|Drug|ifosfamide|
12028484|NCT00379457|Drug|topotecan hydrochloride|
12028485|NCT00379457|Drug|vincristine sulfate|
12028486|NCT00379457|Drug|vinorelbine tartrate|
12028487|NCT00379457|Procedure|conventional surgery|
12028488|NCT00379457|Radiation|radiation therapy|
12028489|NCT00379444|Behavioral|Standard intervention (counseling + self-help written materials)|counseling
12028490|NCT00379444|Behavioral|Enhanced Intervention (same as standard treatment plus 10-15 min of counseling and a culturally tailored video)|counseling
12028491|NCT00379431|Drug|Administration of rituximab and methylprednisolone|"Rituximab:
~Pharmaceutical form: Concentrate for solution for infusion. Maximum duration of treatment: 28 weeks Maximum dose allowed: 2000 mg (use of total dose) Route of administration: intravenous use."
12028492|NCT00379418|Drug|Abciximab|
12028493|NCT00379405|Drug|Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours|Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours
12028494|NCT00379392|Behavioral|Mental Imagery only|Listening to an audio tape to enhance mental imagery of functional activities of the affected upper extremity
12028495|NCT00379392|Procedure|Mental Imagery and Constraint induced therapy|Listening to an audio tape to enhance mental imagery AND participation in constraint induced therapy
12028496|NCT00379379|Device|electroacupuncture|
12028497|NCT00379366|Device|External ionizing radiations|14 Gy in one time
12028498|NCT00379353|Drug|Thalidomide|100 mg capsules orally, once a day for 14 days.
12028499|NCT00379353|Drug|Placebo|Two placebo capsules orally, once a day for 14 days.
12028500|NCT00379340|Drug|doxorubicin hydrochloride|Given IV
12028501|NCT00379340|Drug|liposomal vincristine sulfate|Given IV
12028502|NCT00379340|Procedure|conventional surgery|
12028503|NCT00379340|Radiation|3-dimensional conformal radiation therapy|
12028504|NCT00379340|Biological|dactinomycin|Given IV
12028505|NCT00379340|Drug|cyclophosphamide|Given IV
12028506|NCT00379340|Drug|etoposide|Given IV
12028507|NCT00379327|Procedure|Acupuncture|Acupuncture administered in last three weeks of pregnancy
12028508|NCT00379327|Device|Non-puncturing Acupuncture Needle|Streitsberg non-Acupuncture Needle
12028509|NCT00379314|Procedure|TVT and TVT-O minimally invasive surgical procedures|
12028510|NCT00379314|Procedure|Surgery for female stress urinary incontinence|
12028511|NCT00379301|Procedure|Radiofrequency ablation|Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.
12028512|NCT00379288|Drug|mometasone furoate combination MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
12028513|NCT00379288|Drug|mometasone furoate combination MDI 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
12028514|NCT00379288|Drug|Fluticasone/Salmeterol 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
12028515|NCT00379288|Drug|Fluticasone/Salmeterol 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
12028516|NCT00379262|Drug|Capecitabine|Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
12028517|NCT00379262|Drug|Adjuvant chemotherapy using PF (5-Fluorouracil )|Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles
12028518|NCT00379262|Drug|Induction chemotherapy using PF (5-Fluorouracil)|Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles
12028519|NCT00379249|Drug|Rosuvastatin|
12028520|NCT00379236|Device|EUFLEXXA™|EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate (molecular weight 2.4-3.6 MD); sodium chloride, 17 mg; disodium hydrogen phosphate dodecahydrate, 1.12 mg; sodium dihydrogen phosphate dihydrate, 0.1 mg; enough water for injection to make 2.0 ml. EUFLEXXA™ is supplied in 2.25 ml nominal volume, disposable prefilled glass syringes containing 2 mL of EUFLEXXA™. Only the contents of the syringe are sterile. EUFLEXXA™ is nonpyrogenic. See package insert for further details.
12028521|NCT00379236|Device|placebo|Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Only the contents of the syringe are sterile.
12028522|NCT00379223|Procedure|vitrectomy with radial optic neurotomy|
12028523|NCT00379210|Behavioral|Mindfulness Meditation Training (MMT)|8-week training course in mindfulness meditation
12028524|NCT00379210|Behavioral|Nutrition Education course|8-week course in nutrition
12028525|NCT00379197|Drug|naltrexone|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.
12028603|NCT00378703|Biological|Bevacizumab|Given IV
12028604|NCT00378703|Other|Laboratory Biomarker Analysis|Correlative studies
12028526|NCT00379197|Procedure|PET scan|Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.
12028527|NCT00379171|Behavioral|Cow's milk with fish oil|
12028528|NCT00379171|Behavioral|Cow's milk without fish oil|
12028529|NCT00379171|Behavioral|Formula with fish oil|
12028530|NCT00379171|Behavioral|Formula without fish oil|
12028531|NCT00379158|Drug|Micronutrient supplements|
12028532|NCT00379145|Drug|trabectedin|
12028533|NCT00379132|Drug|131-I-TM-601 (chlorotoxin)|"Patients will be administered 1 - 3 (Test Doses A, B, and Dose C) escalating doses of 131I-TM601 by intravenous (IV) administration. Each dose will be administered as a single administration, scheduled at one-week intervals.
~Test Dose A - 10 mCi (+/- 20%)/0.2 mg TM601 (131I-TM601) Test Dose B - 20 mCi (+/- 20%)/0.4 mg TM601 (131I-TM601) Dose C - 30 mCi (+/- 10%)/0.6 mg TM601 (131I-TM601)"
12028534|NCT00379119|Other|diagnostic laboratory biomarker analysis|
12028535|NCT00379119|Other|flow cytometry|
12028536|NCT00379119|Other|physiologic testing|
12028537|NCT00379119|Procedure|computed tomography|
12028538|NCT00379106|Procedure|Arm exercises.|Basic active exercise program at home.
12028539|NCT00379106|Procedure|Arm Exercises|Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises
12028540|NCT00379093|Behavioral|Brief advice|"The intervention will have the following components:
~A) At the time of the recruitment visit, all intervention group patients will receive:
~A personalized risk report;
~An educational booklet titled Healthy Drinking as You Age;
~A drinking diary;
~Brief advice to reduce their drinking by their physicians;
~B) After the recruitment visit, all intervention group patients will receive up to 3 telephone calls from a health educator. After each call, intervention group patients may choose to receive a letter updating their health risks.
~Also, at the conclusion of their interaction with the health educator, they may choose to have a letter summarizing the calls sent to their physician."
12028541|NCT00379080|Procedure|conventional surgery|Undergo surgery
12028542|NCT00379080|Drug|tandutinib|Given orally
12028543|NCT00379080|Other|pharmacological study|Correlative studies
12028544|NCT00379080|Other|Tissue samples|Correlative studies
12028545|NCT00379067|Drug|Tamsulosin OCAS|Adrenoceptor antagonist
12028546|NCT00379067|Drug|Placebo|placebo
12028547|NCT00379054|Behavioral|telephone based skills training intervention|
12028548|NCT00379041|Biological|bleomycin sulfate|
12028549|NCT00379041|Drug|doxorubicin hydrochloride|
12028550|NCT00379041|Drug|mechlorethamine hydrochloride|
12028551|NCT00379041|Drug|prednisone|
12028552|NCT00379041|Drug|procarbazine hydrochloride|
12028553|NCT00379041|Drug|vinblastine sulfate|
12028554|NCT00379041|Drug|vincristine sulfate|
12028555|NCT00379041|Radiation|radiation therapy|
12028556|NCT00379028|Drug|Budesonide/Formoterol Turbuhaler|
12028557|NCT00379028|Drug|Salmeterol/Fluticasone Diskus|
12028558|NCT00379015|Biological|trastuzumab|
12028559|NCT00379015|Drug|cyclophosphamide|
12028560|NCT00379015|Drug|docetaxel|
12028561|NCT00379015|Drug|epirubicin hydrochloride|
12028562|NCT00379015|Procedure|conventional surgery|
12028563|NCT00379015|Procedure|neoadjuvant therapy|
12028564|NCT00378989|Behavioral|Consultation at the occupational health services|Consultation at the occupational health services
12028565|NCT00378976|Drug|valacyclovir|500 mg twice-daily oral
12028566|NCT00378976|Drug|matching placebo|twice daily as per experimental drug
12028567|NCT00378963|Device|ProAdjuster|
12028568|NCT00378950|Behavioral|Teach to Goal (TTG)|The TTG program includes the Brief Educational Intervention (BEI) educational intervention, as well as education about diuretic self adjustment. In addition, follow-up phone calls are given to the TTG group to further reinforce the initial training and provide further training so participants will master the task.
12028569|NCT00378950|Behavioral|Brief Educational Intervention (BEI)|The BEI is a one hour educational session on CHF, symptom recognition, diet, exercise, and daily checkups.
12028570|NCT00378937|Drug|acetaminophen|
12028571|NCT00378937|Drug|codeine phosphate|
12028572|NCT00378937|Drug|dextropropoxyphene hydrochloride|
12028573|NCT00378937|Drug|morphine sulfate|
12028574|NCT00378937|Drug|oxycodone hydrochloride|
12028575|NCT00378937|Procedure|management of therapy complications|
12028576|NCT00378937|Procedure|quality-of-life assessment|
12028577|NCT00378911|Drug|sunitinib malate|Given orally
12028578|NCT00378898|Device|BRAVO capsule|
12028579|NCT00378898|Procedure|Fluoroscopy|"one time xray to determine evacuation of bravo"
12028580|NCT00378898|Other|sham BRAVO capsule placement|
12028581|NCT00378885|Behavioral|Cognitive-behavioral tailored intervention|
12028582|NCT00378872|Drug|IV Tranexamic acid 10mg/kg pt body weight|
12028583|NCT00378872|Drug|Quixil topical sealant|
12028584|NCT00378859|Behavioral|Skim milk|
12028585|NCT00378859|Behavioral|Lean meat|
12028586|NCT00378846|Procedure|infrared thermography|
12028587|NCT00378833|Drug|niacin (+) laropiprant|Duration of Treatment: 18 Weeks
12028588|NCT00378833|Drug|niacin|Duration of Treatment: 18 Weeks
12028589|NCT00378820|Behavioral|Whey without milk minerals|
12028590|NCT00378820|Behavioral|Whey with milk minerals|
12028591|NCT00378820|Behavioral|Casein without milk minerals|
12028592|NCT00378820|Behavioral|Casein with milk minerals|
12028593|NCT00378781|Drug|Heparin|Heparin flush solution into CVC once daily.
12028594|NCT00378781|Drug|Minocycline-EDTA|M-EDTA flush solution into CVC once daily.
12028595|NCT00378768|Biological|anti-thymocyte globulin|
12028596|NCT00378755|Drug|velcade|
12028597|NCT00378729|Drug|Metformin and FSHr|treatment for infertility
12028598|NCT00378729|Procedure|Ovarian drilling by FERTILOSCOPY|surgical ovarian drilling
12028599|NCT00378716|Drug|5-fluorouracil|
12028600|NCT00378716|Drug|leucovorin calcium|
12028601|NCT00378716|Drug|tegafur|
12028605|NCT00378703|Other|Pharmacological Study|Correlative studies
12028606|NCT00378703|Drug|Sorafenib Tosylate|Given PO
12028607|NCT00378703|Drug|Temsirolimus|Given IV
12028608|NCT00378690|Drug|leuprorelin acetate|LHRH antagonist
12028609|NCT00378677|Drug|Cyclosporine A dry powder inhalation (Drug)|
12028610|NCT00378664|Procedure|lumbar to sacral ventral nerve re-routing procedure|surgical nerve re-routing procedure
12028611|NCT00378651|Procedure|Neck Auscultation|
12028612|NCT00378638|Drug|bevacizumab combined with dose dense chemotherapy|
12028613|NCT00378625|Drug|Artesunate|
12028614|NCT00378612|Device|Cypher sirolimus eluting coronary stent|Cypher® sirolimus eluting coronary stent ranging in diameters 2.5 to 3.5 mm and available in length from 8 to 33 mm.
12028615|NCT00378599|Drug|Combination of (a) pegylated interferon alfa-2b and (b) rebetol|"Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
~200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks"
12028616|NCT00378586|Procedure|Rectal biopsy|Rectal biopsy.
12028617|NCT00378586|Procedure|Measurement of inflammatory markers in the rectal mucosa|IL-6, TNF-alfa.
12028618|NCT00378586|Procedure|Measurement of rectal lactic acid|Equilibrium dialysis.
12028619|NCT00378573|Drug|docetaxel|
12028620|NCT00378573|Drug|gemcitabine|
12028621|NCT00378573|Drug|bevacizumab|
12028622|NCT00378560|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|V501; Gardasil, 0.5 ml injection in 3 dosing regimen
12028623|NCT00378560|Biological|Comparator: Placebo|Placebo 0.5 ml injection in 3 dosing regimen
12028624|NCT00378547|Drug|paracetamol + placebo + placebo|Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
12028625|NCT00378547|Drug|paracetamol + pregabalin + placebo|Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
12028626|NCT00378547|Drug|paracetamol + pregabalin + dexamethasone|Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
12028627|NCT00378534|Device|Miltenyi reagent system|Miltenyi Clinimax CD34 Reagent System for CD34 selectioni and delayed T cell depletion add back
12028628|NCT00378534|Drug|Fludarabine|Therapeutic
12028629|NCT00378534|Drug|Cyclosporine|Therapeutic
12028630|NCT00378534|Drug|Cyclophosphamide|Therapeutic
12028631|NCT00378521|Drug|MQX-503|
12028632|NCT00378508|Drug|mAb hOKT3gamma1(Ala-Ala), Teplizumab|This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.
12028633|NCT00378508|Drug|Placebo Arm|
12028634|NCT00378495|Drug|Miltefosine: initially 2.5 mg/kg/day for 28 days|
12028635|NCT00378482|Drug|CP-675,206 (Tremelimumab)|15 mg/kg IV every 3 months as long as required
12028636|NCT00378469|Behavioral|45 minute exercise on ergocycle|
12028637|NCT00378456|Drug|Antioxidants- (Vitamins A,C,E Selenium and Zinc)|
12028638|NCT00378456|Drug|Folinic acid|
12028639|NCT00378456|Drug|Vitamins A,C,E Selenium and Zinc and Folinic acid.|
12028640|NCT00378456|Drug|Placebo|
12028641|NCT00378443|Drug|prednisone + Inhibace/Cozaar|
12028642|NCT00378443|Drug|Inhibace/Cozaar|
12028643|NCT00378417|Biological|7-valent pneumococcal-CRM197 conjugate vaccine|
12028644|NCT00378417|Biological|7-valent pneumococcal-OMPC conjugate vaccine|
12028645|NCT00378404|Drug|Docetaxel|30 mg/m2 IV on days 1, 8, 15 every 28 days for 6 cycles
12028646|NCT00378404|Radiation|Radiation|50 - 80 cGy on days 1, 8, 15 every 28 days for 6 cycles
12028647|NCT00378378|Drug|Mometasone Furoate Nasal Spray (MFNS)|100 mcg nasal spray
12028648|NCT00378378|Drug|Placebo nasal spray|One spray of placebo nasal spray in each nostril once daily for 4 months.
12028649|NCT00378365|Procedure|Arsenic trioxide|Arsenic trioxide
12028650|NCT00378365|Procedure|ATRA|ATRA
12028651|NCT00378352|Drug|Epoetin alfa|Randomized
12028652|NCT00378339|Device|gold berlocks|
12028653|NCT00378326|Drug|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
12028654|NCT00378313|Drug|gemcitabine, epirubicin, paclitaxel|
12028655|NCT00378300|Drug|Oral Probiotics|
12028656|NCT00378287|Drug|rabeprazole sodium|
12028657|NCT00378274|Behavioral|Observation|
12028658|NCT00378261|Procedure|Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.|
12028659|NCT00378248|Behavioral|Combined psychotherapy|18 weeks day hospital treatment followed by long-term outpatient combined group-and individual psychotherapy
12028660|NCT00378248|Behavioral|Outpatient individual psychotherapy|Eclectic individual psychotherapy in private practice
12028661|NCT00378235|Drug|IL13-PE38QQR|
12028662|NCT00378222|Procedure|Autologous Stem Cell Transplantation|
12028663|NCT00378209|Drug|Bortezomib|Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.
12028664|NCT00378209|Drug|Lenalidomide|Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles
12028665|NCT00378209|Drug|Dexamethasone|Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles
12028666|NCT00378196|Drug|Ranibizumab|0.3 mg/0.05 ml dose
12028667|NCT00378196|Drug|Ranibizumab|0.5 mg/0.05 ml dose
12028668|NCT00378183|Drug|risperidone|
12028669|NCT00378170|Device|intubation of patients undergoing elective surgery|
12028670|NCT00378157|Behavioral|Joint attention intervention|Eight weeks with two daily sessions (20 minutes) with joint attention intervention in the pre-school.
12028671|NCT00378144|Drug|Pseudoephedrine/Paracetamol|Fixed oral tablet doses, 2 tablets 3 times a day for 5 days with at least 4 hours between each treatment (morning-noon-evening) and last dose not later than 2 hours before bedtime [Paracetamol (500 mg) and Pseudoephedrine (30 mg)]
12028672|NCT00378131|Drug|RC-1291|
12028674|NCT00378118|Other|Abbott-rapid HIV antibody test|Abbott will be used to test serum or whole blood
12028675|NCT00378118|Other|OraQuick Rapid HIV-1/2 Antibody test|OraQuick for oral fluid HIV antibody testing
12028676|NCT00378105|Drug|Bortezomib|Intravenously on days 1, 4, 8 and 11 of a 21 day cycle for a minimum of 8 cycles (dosage will vary depending upon when the participant enters the trial)
12028677|NCT00378105|Drug|Lenalidomide|Taken orally twice a day for 2 weeks (days 1-14) of each 21-day cycle for a minimum of 8 cycles (dosage will vary depending upon when participant enters trial).
12028678|NCT00378105|Drug|dexamethasone|Taken orally on days 1,2,4,5,8,9,11 of a 21-day cycle for a minimum of 8 cycles.
12028679|NCT00378092|Drug|Oral risperidone|Oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injection becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits.
12028680|NCT00378092|Drug|Risperidone Long-Acting Injection (RLAI)|RLAI 25 mg to 50 mg will be administered, intramuscularly which will be tapered and discontinued over a period of up to 6 weeks.
12028681|NCT00378092|Drug|Risperidone Long-Acting Injection (RLAI)|Participants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus for up to 24 months.
12028682|NCT00378079|Other|Counseling Only|Counseling only in prison, with passive referral to drug abuse treatment upon release
12028683|NCT00378079|Drug|Counseling + Transfer|Counseling only in prison, with opportunity to enter methadone maintenance upon release
12028684|NCT00378079|Drug|Counseling + Methadone|Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
12028685|NCT00378066|Drug|Bevacizumab|Bevacizumab, Capecitabine, Oxaliplatin
12028686|NCT00378027|Drug|Fondaparinux|Administer Fondaparinux Risk Stratify
12028687|NCT00378014|Drug|everolimus|Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.
12028688|NCT00378014|Drug|basiliximab|All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
12028689|NCT00378014|Drug|CNI|Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
12028690|NCT00378001|Drug|FSH-IBSA|
12028691|NCT00378001|Drug|GONAL-F|
12028692|NCT00377988|Drug|Transdermal Contraceptive System|In each 4-week period, exposed subjects will wear a transdermal patch containing 6 mg norelgestromin and 0.75 mg EE worn for each of 3 consecutive weeks with no patch the 4th week.
12028693|NCT00377988|Drug|Norgestimate-containing oral contraceptives with EE|NGM-OCs with 34 mcg of EE taken during each 4 week period for 21 consecutive days, then no pill or a drug-free pill 7 days.
12028694|NCT00377975|Drug|Ephedrine|
12028695|NCT00377975|Drug|Pioglitazone|
12028696|NCT00377975|Drug|Caffeine|
12028697|NCT00377962|Drug|Everolimus|0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.
12028698|NCT00377962|Drug|Mycophenolic acid (MPA)/azathioprine (AZA)|In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.
12028699|NCT00377962|Drug|Calcineurin inhibitors (CNI)|Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.
12028700|NCT00377962|Drug|Steroids|Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.
12028701|NCT00377936|Drug|Gemcitabine alone|Gemcitabine monotherapy 1000 mg/m2 weekly
12028702|NCT00377936|Drug|EndoTAG-1 and Gemcitabine|EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
12028703|NCT00377936|Drug|EndoTAG-1 and Gemcitabine|EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
12028704|NCT00377936|Drug|EndoTAG-1 and Gemcitabine|EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
12028705|NCT00377923|Drug|Progesterone|
12028706|NCT00377910|Drug|Aethoxysclerol|2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml
12028707|NCT00377897|Procedure|cell therapy|Injection of Bone-Marrow mononuclear cells in the muscles of the calf.
12028708|NCT00377871|Device|biological heart valve prosthesis|Two heart valve designs
12028709|NCT00377858|Drug|Insulin lispro mid mixture (MM)|Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
12028710|NCT00377858|Drug|Insulin glargine|Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
12028711|NCT00377845|Procedure|Regular Tampax used in 3 hours|
12028712|NCT00377832|Drug|Acetaminophen 975 mg|Acetaminophen 975 mg by mouth once only
12028713|NCT00377819|Drug|alendronate|70 mg oral QW
12028714|NCT00377819|Drug|Denosumab (AMG 162)|60 mg SC q 6 mos
12028715|NCT00377806|Drug|Diclofenac gel|
12028716|NCT00377793|Drug|Levitra (Vardenafil, BAY38-9456)|
12028717|NCT00377793|Drug|Placebo|
12028718|NCT00377780|Drug|Non pegylated liposomal doxorubicin, trastuzumab, docetaxel|max. 6 courses
12028719|NCT00377767|Behavioral|To change structure and roles of primary care teams to optimize prevention of obesity|
12028720|NCT00377741|Drug|valganciclovir [Valcyte]|900mg po
12028721|NCT00377728|Drug|GSK256066|
12028722|NCT00377715|Drug|Dimebon|
12028723|NCT00377715|Drug|Placebo|
12028724|NCT00377689|Behavioral|high intensity functional exercise|high intensity functional exercise
12028725|NCT00377676|Drug|Cycloset|Usual diabetes therapy plus Cycloset
12029008|NCT00375570|Drug|ME-609|Topical treatment 5 times daily for 5 days
12028726|NCT00377676|Drug|Usual Diabetes Therapy plus placebo|Placebo tablet taken orally once in the morning, beginning with one tablet daily, titrated up by 1 tablet each week to a maximum of 6 tablets daily
12028727|NCT00377663|Behavioral|AsthmaNet|The AsthmaNet Web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition.
12028728|NCT00377650|Device|Percutaneous thrombectomy|
12028729|NCT00377637|Drug|Mycophenolate mofetil (MMF)|Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.
12028730|NCT00377637|Drug|Cyclophosphamide|"Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.
~Dosing was started at 0.75 g/m^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m^2. The target dose was 1.0 g/m^2, but doses were titrated by 0.25 g/m^2 increments to maintain nadir leukocyte count between 2500-4000/mm^3."
12028731|NCT00377637|Drug|Azathioprine|2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.
12028732|NCT00377637|Drug|Placebo to Azathioprine|Placebo capsules matching Azathioprine taken orally once a day.
12028733|NCT00377637|Drug|Placebo to Mycophenolate mofetil|Placebo tablets matching Mycophenolate mofetil taken orally twice daily.
12028734|NCT00377637|Drug|Corticosteroid|Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
12028735|NCT00377624|Drug|sodium hyaluronate|
12028736|NCT00377611|Biological|Fluarix™|
12028737|NCT00377598|Drug|TAK-583|TAK-583 5 mg, tablets, orally, once daily for up to 8 weeks
12028738|NCT00377598|Drug|TAK-583|TAK-583 25 mg, tablets, orally, once daily for up to 8 weeks
12028739|NCT00377598|Drug|TAK-583|TAK-583 50 mg, tablets, orally, once daily for up to 8 weeks
12028740|NCT00377598|Drug|TAK-583|TAK-583 100 mg, tablets, orally, once daily for up to 8 weeks
12028741|NCT00377598|Drug|Placebo|TAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks
12028742|NCT00377585|Biological|Fluarix|
12028743|NCT00377585|Biological|adjuvanted influenza vaccine|
12028744|NCT00377572|Biological|omalizumab|Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
12028745|NCT00377572|Biological|omalizumab placebo|Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
12028746|NCT00377559|Drug|Non pegylated liposomal doxorubicin and docetaxel|max. 6 courses
12028747|NCT00377546|Drug|Nepafenac|
12028748|NCT00377546|Drug|Ketorolac LS, Bromfenac|
12028749|NCT00377533|Device|wheelchair rear anti-tip device|assistive device
12028750|NCT00377520|Drug|pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
12028751|NCT00377507|Dietary Supplement|catechin extracts|catechin extracts solution
12028752|NCT00377494|Biological|MVA-CSO Vaccine|
12028753|NCT00377494|Biological|PfCSP DNA (VCL-2510) Vaccine|
12028754|NCT00377481|Drug|darbepoetin alfa|30 micrograms sc weekly (2 doses)
12028755|NCT00377481|Drug|epoetin beta [NeoRecormon]|6000 IU sc weekly (2 doses)
12028756|NCT00377468|Drug|Delta9-Tetrahydrocannabinol|
12028757|NCT00377455|Drug|Bosentan|62.5 mg by mouth (PO) twice daily (Bid) for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
12028758|NCT00377455|Drug|Placebo|62.5 mg PO Bid for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
12028759|NCT00377442|Drug|GK Activator (2)|100mg po
12028760|NCT00377442|Drug|Simvastatin|80mg po
12028761|NCT00377429|Drug|catumaxomab|Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).
12028762|NCT00377416|Genetic|rAAV2-CB-hAAT Gene Vector|Participants will attend a 5-day inpatient visit, during which they will receive a series of injections consisting of one of four different doses of rAAV2-CB-hAAT.
12028763|NCT00377403|Drug|Acetaminophen|"Symptomatic treatment:
~Dose: 500mg every 4 to 6 hours for pain or fever"
12028764|NCT00377403|Drug|Amoxicillin|"Intervention drug:
~Dose: 500mg tid for 10 days"
12028765|NCT00377403|Drug|Dextromethorphan hydrobromide with guaifenesin|"Symptomatic treatment:
~Dose: 10mls every 4 to 6 hours for cough"
12028766|NCT00377403|Drug|Guaifenesin|"Symptomatic treatment:
~Dose: 600mg every 12 hours to thin secretions"
12028767|NCT00377403|Drug|Pseudoephedrine Sustained Action|"Symptomatic treatment:
~Dose: 120mg every 12 hours for nasal congestion"
12028768|NCT00377403|Drug|Saline spray (0.65%)|"Symptomatic treatment:
~Dose: 2 squeezes per nostril as needed for nasal congestion"
12028769|NCT00377390|Biological|Omalizumab|Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standardized asthma care for 60 weeks, beginning with the Randomization Visit, as a part of ICATA (ICAC-08, NCTNCT00377572).
12028770|NCT00377377|Drug|EP1572 (ghrelin agonist) oral and duodenal application|
12028771|NCT00377364|Drug|Drug: Acetaminophen, Drug: Placebo|Acetaminophen: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days, not exceeding 4,000 mg/day. Placebo: Participants will be given placebo(two 500 mg tablets) four times daily for 7 days
12028772|NCT00377325|Drug|Cyclosporine|4 mg/Kg/day; daily; liquid form; 6 months
12028773|NCT00377312|Drug|Parathyroid Hormone (1-34)|PTH(1-34) IV given over a one week period
12028774|NCT00377299|Drug|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. Citicoline or placebo (identical in appearance) add-on therapy was given beginning at one tablet (500mg/day) with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4 and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.
12028775|NCT00377299|Drug|Placebo|Placebo matching active medication in all other physical aspects
12029069|NCT00374985|Drug|Docetaxel, Oxaliplatin|weekly doses
12028776|NCT00377286|Dietary Supplement|Glucosamine (a dietary supplement)|1500 mg in 16 oz lite lemonade, once per day for 6 months
12028777|NCT00377286|Other|16 oz lite lemonade|16 oz lite lemonade 1 time daily for 6 months
12028778|NCT00377273|Drug|fluorouracil cream 0.5%|
12028779|NCT00377260|Drug|amoxicillin-clavulanate|Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor.
12028780|NCT00377260|Drug|Placebo|Same base formulation of the licensed product Augmentin ES-600™, with the same strawberry cream flavor.
12028781|NCT00377247|Biological|autologous monocyte-derived dendritic cells (DC) transfected with DNA|The patients will receive 1 x 107 DC/vaccine delivered intranodally or perinodally to lymph nodes (LN) distant from the head and neck area (e.g., to inguinal LN)
12028782|NCT00377234|Drug|Risedronate|35mg po weekly for 12 weeks
12028783|NCT00377234|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 3 months
12028784|NCT00377208|Behavioral|Web-Based Intervention|"My Expert Doctor is a web-based program that helps patients to ask the right questions regarding specific tests and treatments during their doctor visits. Upon entering medication and treatment information into the web site, patients are provided with individualized feedback and recommended questions to ask their doctor."
12028785|NCT00377195|Radiation|Involved Field Radiotherapy|"The prescribed dose will be 30 Gy in 15-20 fractions, unless the orbit is to be treated, in which case the dose will be 24 Gy in 1.5 to 2 Gy fractions.
~Daily fractions of 1.5-2.0 Gy will be employed. Treatment will be given 5 days per week with the planned duration of treatment not exceeding 28 days."
12028786|NCT00377182|Drug|Copegus|1000/1200mg po daily for 4 weeks
12028787|NCT00377182|Drug|PEGASYS|180 micrograms sc weekly for 4 weeks
12028788|NCT00377182|Drug|RO5024048 1500mg|1500mg po bid for 4 weeks
12028789|NCT00377182|Drug|RO5024048 3000mg|3000mg po bid for 4 weeks
12028790|NCT00377156|Radiation|radiation therapy|Patients undergo radiation therapy 5 days a week for 2.5 weeks
12028791|NCT00377156|Radiation|stereotactic radiosurgery|
12028792|NCT00377143|Drug|Warfarin Dosing|
12028793|NCT00377130|Other|Self Administered Stress Management|"The SSMT kit includes a DVD and booklet will discuss the sources and manifestations of stress during chemotherapy and the potential benefits of stress management training. The videotape/DVD and booklet will also include brief instruction in paced breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements as well as recommendations for practicing the techniques before the start of chemotherapy and using them after the start of treatment. The exercise combines abbreviated progressive muscle relaxation training with use of relaxing mental imagery. The positive thinking exercise provides participants with brief instruction in the use of coping self-statements using techniques borrowed from stress inoculation training."
12028794|NCT00377117|Procedure|Management|
12028795|NCT00377117|Procedure|Screening|
12028796|NCT00377104|Drug|alvocidib|Given IV
12028797|NCT00377104|Other|pharmacological study|Correlative studies
12028798|NCT00377104|Other|laboratory biomarker analysis|Correlative studies
12028799|NCT00377091|Drug|Fondaparinux|
12028800|NCT00377078|Drug|recombinant human lactoferrin|
12028801|NCT00377065|Drug|raltegravir|raltegravir 400 mg P.O. bid tablet twice daily for 12 weeks
12028802|NCT00377052|Drug|bortezomib|1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks
12028803|NCT00377052|Drug|gemcitabine hydrochloride|1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks
12028804|NCT00377039|Drug|AD 337|
12028805|NCT00377026|Behavioral|lifestyle intervention|Lifestyle modification including individual sessions with an interventionist to discuss dietary intake and exercise. Group sessions with other participants randomized to the lifestyle intervention to discuss lifestyle modification and group exercise.
12028806|NCT00377000|Drug|clindamycin 1% / benzoyl peroxide 5% gel pump|
12028807|NCT00377000|Drug|clindamycin 1% / benzoyl peroxide 5% tube|
12028808|NCT00376987|Dietary Supplement|zinc oxide|Oral daily dietary supplement containing 80 mg Zinc oxide
12028809|NCT00376974|Behavioral|American Academy of Ophthalmology Glaucoma Educational Tape|
12028810|NCT00376961|Biological|rituximab|375 mg/m^2 on day 1 for cycles 1-6.
12028811|NCT00376961|Drug|bortezomib|1.3 mg/m^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.
12028812|NCT00376961|Drug|cyclophosphamide|750 mg/m^2 on day 1 of cycles 1-6.
12028813|NCT00376961|Drug|doxorubicin hydrochloride|50 mg/m^2 on day 1 of cycles 1-6.
12028814|NCT00376961|Drug|prednisone|100 mg on days 1-5 of cycles 1-6.
12028815|NCT00376961|Drug|vincristine sulfate|1.4 mg/m^2 on day 1 of cycles 1-6.
12028816|NCT00376948|Dietary Supplement|genistein|
12028817|NCT00376948|Drug|erlotinib hydrochloride|
12028818|NCT00376948|Drug|gemcitabine hydrochloride|
12028819|NCT00376935|Drug|Palifermin|Keratinocyte growth factor administered via injection
12028820|NCT00376935|Drug|Palifermin placebo|Keratinocyte growth factor placebo administered via injection
12028821|NCT00376922|Procedure|music therapy|music played for patient during bone marrow biopsy collection
12028822|NCT00376909|Other|educational intervention|
12028823|NCT00376909|Other|study of socioeconomic and demographic variables|
12028824|NCT00376896|Drug|GW876008 200mcg|GW876008
12028825|NCT00376896|Drug|GW876008 20mcg|GW876008 20mcg
12028826|NCT00376896|Other|Placebo|placebo
12028827|NCT00376883|Drug|pamidronate|
12028828|NCT00376870|Drug|Pioglitazone|pioglitazone 30 mg/d
12028829|NCT00376870|Drug|Placebo|Placebo 30 mg/d
12028830|NCT00376857|Drug|Surgery with and without the aid of Indocyanine Green (ICG)|
12028831|NCT00376844|Radiation|External Beam Radiation Therapy|
12028832|NCT00376844|Radiation|Vaginal Brachytherapy|
12028833|NCT00376831|Drug|Midazolam, Fentanyl|fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
12028834|NCT00376831|Drug|KETAMINE, MIDAZOLAM|Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
12029070|NCT00374985|Procedure|Radiotherapy|regular fractions
12029071|NCT00374959|Drug|ceftriaxone|
12028835|NCT00376818|Behavioral|exercise intervention|All participants will convene once per week for 8 weeks for a 90-minute session that will be based on yoga principles for a stress reduction.
12028836|NCT00376818|Other|educational intervention|A 15-minute educational session on a particular topic (mind-body connection; fight or flight response; relaxation response; the science and philosophy of yoga; the science of meditation; sleeping well; mindfulness; the healer within - how to harness your innate healing potential).
12028837|NCT00376818|Other|physiologic testing|Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.
12028838|NCT00376818|Other|management of therapy complications|Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.
12028839|NCT00376818|Behavioral|mind-body intervention procedure|"Meditation practice in this study will consist of 15 minutes of body scan to completely relax the body from head to toe and will be followed by 15 minute silence during which the study participants will maintain awareness of their breath, bodily sensations and thoughts as they spontaneously arise. The remainder of the class will be devoted to a group discussion of personal reflections and challenges."
12028840|NCT00376818|Procedure|Measurement of stress-related hormones|Measurements of stress-related hormones: Stress hormones cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin will be measured in saliva because their levels in saliva accurately reflect blood levels (Carlson et al, 2004). The non-invasive saliva collection method by cotton swabs (Salivette® by Sardstedt Inc.) will be used in this study.
12028841|NCT00376805|Drug|Fludarabine|administered intravenously 25 mg/m^2 times 5 doses
12028842|NCT00376805|Drug|Cyclophosphamide|administered intravenously 60 mg/kg days times 2 doses.
12028843|NCT00376805|Radiation|Total body irradiation|200 cGy (gray) on day -1
12028844|NCT00376805|Other|Natural killer cell infusion|Infused cell dose is within the range of 1.5-8.0 x 10^7/kg. Cell counts are based on total cells infused after the activation culture and washing determined on the morning of infusion.
12028845|NCT00376805|Biological|Interleukin-2|administered subcutaneously (10 MU) 3 times per week for 6 doses
12028846|NCT00376792|Drug|docetaxel|
12028847|NCT00376792|Other|active surveillance|
12028848|NCT00376792|Procedure|adjuvant therapy|
12028849|NCT00376779|Biological|Infanrix hexa Vaccine|
12028850|NCT00376766|Drug|levetiracetam|
12028851|NCT00376740|Drug|zoledronic acid|Zoledronic acid 4 mg IV every 6 months up to 2.5 years after the start of letrozole treatment.
12028852|NCT00376727|Biological|cetuximab|Dose level 0: cetuximab 400 mg/m2 week 1, 250 mg/m2 weekly; Dose level 1: cetuximab 400 mg/m2 week 1, 300 mg/m2 weekly; Dose level 2: cetuximab 400 mg/m2 week 1, 350 mg/m2 weekly; Dose level 3: cetuximab 400 mg/m2 week 1, 400 mg/m2 weekly
12028853|NCT00376727|Genetic|molecular diagnostic method|Tissue and Blood Specimens; IHC Methodology; IHC Scoring; K-RAS Mutation Analysis
12028854|NCT00376727|Other|immunologic technique|Peripheral Blood Mononuclear Cells (PBMC)
12028855|NCT00376727|Other|laboratory biomarker analysis|Cetuximab Pharmacodynamics
12028856|NCT00376714|Drug|GSK233705|
12028857|NCT00376701|Drug|Avastin (Bevacizumab)|Avastin 1.25 mg intravitreal
12028858|NCT00376701|Drug|Bevacizumab|Intravitreal 1.25 mg
12028859|NCT00376701|Drug|Bevacizumab|Intravitreal 1.25 mg
12028860|NCT00376701|Drug|Bevacizumab|Intravitreal Avastin 1.25 mg and sham reduced fluence PDT
12028861|NCT00376688|Other|Laboratory Biomarker Analysis|Correlative studies
12028862|NCT00376688|Drug|Temsirolimus|Given IV
12028863|NCT00376675|Drug|methylphenidate hydrochloride|Given orally
12028864|NCT00376675|Other|placebo|Given orally
12028865|NCT00376662|Drug|Hormone Replacement Therapy and Etidronate|
12028866|NCT00376649|Behavioral|lifestyle changing workshop|
12028867|NCT00376636|Drug|SPP635 (drug)|
12028868|NCT00376623|Drug|BI 2536|
12028869|NCT00376610|Device|ASR/Re-cap|
12028870|NCT00376597|Other|quality of life assessment|Ancillary studies
12028871|NCT00376597|Other|educational intervention|Receive lymphedema educational materials
12028872|NCT00376597|Procedure|Physical therapy|Complete physical therapy-focused intervention
12028873|NCT00376584|Drug|MK-0524A|
12028874|NCT00376584|Drug|ER Niacin|
12028875|NCT00376584|Drug|Placebo|
12028876|NCT00376571|Procedure|Percutaneous coronary intervention|"Comparing treatment of either no side branch treatment versus stenting of main vessel and side branch treatment"
12028877|NCT00376558|Behavioral|Community Reinforcement Approach|Community Reinforcement Approach (CRA): The community reinforcement treatment program will be carried out in accordance with NIDA's therapy manual (13).During weeks 13 through 24, patients will meet once per week with their therapists. Sessions will focus on promoting continued change in the life areas addressed in the first 12 weeks of treatment or new components are added as needed.
12028878|NCT00376519|Drug|cyclophosphamide|Cyclophosphamide 60 mg/kg/day will be administered as a 2 hour intravenous infusion with a high volume fluid flush and mesna (MT(S)9006) on day -8 and -7 one hour after fludarabine infusion.
12028879|NCT00376519|Drug|cyclosporine|Will be administered beginning on day -3 and adjusted to maintain a level of >200. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours.
12028880|NCT00376519|Drug|fludarabine phosphate|Fludarabine 25 mg/m^2/day will be administered as a 1 hour intravenous infusion on days -9 through -7.
12028881|NCT00376519|Drug|mycophenolate mofetil|All patients will begin mycophenolate mofetil (MMF) on day -3, at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours).
12028882|NCT00376519|Procedure|Treg cell infusion|On day -1 prior to UCB transplantation, Treg cells will be infused IV without in-line filtration. A semi-log dose escalation of CD4+CD25+ Treg cells is scheduled with 3 patients at each step. Doses will be 0.1 x 10^6/kg, 0.3 x 10^6/kg, 1 x 10^6/kg and 3 x 10^6/kg weight (determined on the day prior to administration of the preparative therapy).
12028883|NCT00376519|Procedure|umbilical cord blood transplantation|Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. The UCB will be administrated by IV infusion without in-line filtration.
12028884|NCT00376519|Radiation|total-body irradiation|Radiotherapy: 165 cGy will be administered on day -5 through -2 two fractions each day.
12028885|NCT00376506|Device|Neurostimulation device for dysphagia|A neurostimulation device that is surgically implanted in the swallowing muscles.
12028886|NCT00376506|Device|External vibrotactile device|A vibrotactile device that is placed on the neck during swallowing.
12028887|NCT00376493|Drug|metronidazole and doxycycline|use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
12028888|NCT00376480|Biological|anti-thymocyte globulin|
12028889|NCT00376480|Biological|peripheral blood lymphocyte therapy|
12028890|NCT00376480|Drug|fludarabine phosphate|
12028891|NCT00376480|Drug|methylprednisolone|
12028892|NCT00376480|Drug|thiotepa|
12028893|NCT00376480|Procedure|allogeneic hematopoietic stem cell transplantation|
12028894|NCT00376480|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12028895|NCT00376480|Radiation|total-body irradiation|
12028896|NCT00376467|Drug|Imatinib|
12028897|NCT00376454|Drug|GW493838|
12028898|NCT00376441|Procedure|Vaginal Surgery|patients undergoing vaginal surgery
12028899|NCT00376428|Drug|Gentamicin|
12028900|NCT00376415|Drug|Lessertia Fructescens|Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
12028901|NCT00376415|Drug|Placebo|Participants received an identical placebo capsule twice daily for 3 months.
12028902|NCT00376402|Biological|H5N1 Pandemic Influenza Vaccine|
12028903|NCT00376376|Drug|levofloxacin at 250, 500, 750, and 1000 mg doses|
12028904|NCT00376363|Device|Ahmed implant|placement of glaucoma drainage device to control intraocular pressure
12028905|NCT00376363|Device|Baerveldt implant|placement of glaucoma drainage device to control intraocular press
12028906|NCT00376350|Procedure|Spinal Manipulation|5 minutes high velocity, low amplitude lumbar thrust
12028907|NCT00376350|Procedure|Light Massage|light pressure massage of the low back.
12028908|NCT00376350|Procedure|Pulsed Ultrasound|5 minutes pulsed ultrasound
12028909|NCT00376337|Drug|Micafungin|IV
12028910|NCT00376337|Drug|Systemic antifungal therapy|IV
12028911|NCT00376324|Drug|Tigecycline|Each subject will receive 3 IV doses of tigecycline, as 30-minute infusions: Dose 1 = 100 mgDose 2 = 50 mgDose 3 = 50 mg The doses of tigecycline will be administered to the subjects at approximately 12-hour intervals.
12028912|NCT00376311|Drug|oral salmon calcitonin|
12028913|NCT00376285|Drug|CP-742,033|
12028914|NCT00376285|Drug|Fenofibrate|
12028915|NCT00376272|Drug|Valsartan|
12028916|NCT00376272|Drug|Placebo|
12028917|NCT00376259|Drug|telbivudine|600mg/day oral tablet for 96 weeks
12028918|NCT00376259|Drug|adefovir dipivoxil|10 mg of adefovir by mouth once daily
12028919|NCT00376246|Drug|Ezetimibe|
12028920|NCT00376220|Drug|Riluzole|Initially dispensed 50 mg capsules to take twice a day (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules in the morning (qAM), two capsules in the evening (qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as Montgomery Asberg Depression Rating Scale (MADRS) < 12) the dose will not be increased further unless clinical symptoms recur.
12028921|NCT00376220|Other|Placebo|Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
12028922|NCT00376207|Behavioral|Physical exercise|
12028923|NCT00376194|Drug|DMSA|
12028924|NCT00376181|Drug|Pioglitazone and Azilsartan|Pioglitazone 45 mg and Azilsartan 20 mg combination tablets, orally, once daily for up to 24 weeks.
12028925|NCT00376181|Drug|Pioglitazone and Azilsartan|Pioglitazone 45 mg and Azilsartan 40 mg combination tablets, orally, once daily for up to 24 weeks.
12028926|NCT00376181|Drug|Pioglitazone|Pioglitazone 45 mg, tablets, orally, once daily for up to 24 weeks.
12028927|NCT00376168|Drug|Plant cell expressed recombinant glucocerebrosidase (prGCD)|Intravenous infusion every two weeks for 9 months
12028928|NCT00376168|Drug|Plant cell expressed recombinant glucocerebrosidase (prGCD)|Intravenous infusion every 2 weeks for 9 months
12028929|NCT00376155|Drug|sulfadoxine /pyrimethamine plus amodiaquine|
12028930|NCT00376142|Behavioral|Psychological theory-based behaviour change interventions|
12028931|NCT00376129|Drug|Alefacept|15 mg i.m. once weekly for 12 weeks
12028932|NCT00376116|Device|Cardiac resynchronisation therapy|
12028933|NCT00376116|Device|Implantable cardioverter-defibrillator|
12028934|NCT00376103|Drug|temozolomide|75 mg/m2/day
12028935|NCT00376103|Procedure|Brachytherapy|60 Gy to 1 cm
12028936|NCT00376103|Procedure|External Beam Radiation Therapy|60 Gy
12028937|NCT00376090|Biological|MVA-CMDR|10^7 PFU IM, 1.0 mL
12028938|NCT00376090|Biological|Placebo|1.0 mL IM
12028939|NCT00376090|Biological|MVA-CMDR|10^6 PFU ID, 0.1 mL
12028940|NCT00376090|Biological|Placebo|0.1 mL ID
12028941|NCT00376090|Biological|MVA-CMDR|10^8 PFU IM, 1.0 mL
12028942|NCT00376090|Biological|MVA-CMDR|10^7 PFD ID, 0.1 mL
12028943|NCT00376077|Drug|Methylprednisolone and IVIG|Combination therapy (IV MP (Solu-Medrol®, Upjohn) 30 mg/kg (max. 1 g) over 1 hour followed by IVIG 1 g/kg (Gamunex Immune Globulin Intravenous [Human], 10%; Bayer)* x 1 dose
12028944|NCT00376077|Drug|Placebo and IVIG|Placebo followed by IVIG 1 g/kg (Gamunex Immune Globulin Intravenous [Human], 10%; Bayer)* x 1 dose
12028945|NCT00376064|Drug|Octreotide acetate and cabergoline/Octrotide and Somavert|
12028946|NCT00376051|Drug|Citalopram|Titrates from 10mg/day to 40mg/day, increases 10mg per week.
12028947|NCT00376038|Drug|GSK189075 oral tablets|
12028949|NCT00376025|Dietary Supplement|Biological Antioxidant Supplementation|Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
12028950|NCT00376012|Drug|Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)|Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 4 months.
12028951|NCT00376012|Drug|Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)|Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 7 months.
12028952|NCT00375999|Drug|Docetaxel and epirubicin|
12028953|NCT00375986|Procedure|Manual placental removal at Cesarean delivery|
12028954|NCT00375986|Procedure|Spontaneous placental removal at Cesarean delivery|
12028955|NCT00375973|Drug|Duloxetine|Duloxetine po 60-120 mg/day for 12 weeks
12028956|NCT00375973|Drug|Placebo|Sugar pill dose comparable to duloxetine
12028957|NCT00375960|Drug|V3381|
12028958|NCT00375960|Drug|Placebo|
12028959|NCT00375947|Other|Hand Exercise|
12028960|NCT00375947|Other|sham hand cream|placebo intervention
12028961|NCT00375934|Drug|diclofenac potassium (XP21L)|25 mg capsule, every 6 hours
12028962|NCT00375934|Drug|Placebo|Oral placebo capsule, every 6 hours
12028963|NCT00375895|Drug|ciclosporin|ciclosporin administered orally twice a day, at the initial dosing of 2.5 mg/kg/d, adjusted to obtain a C2 concentration of 600 ng/ml associated with the usual ribavirin and PEGinterferon bitherapy.
12028964|NCT00375882|Procedure|hypothermia|
12028965|NCT00375882|Procedure|cochlear implantation with mild hypothermia|
12028966|NCT00375869|Drug|Darbeopoetin|The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.
12028967|NCT00375869|Drug|Normal Saline (Placebo)|The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.
12028968|NCT00375856|Device|DePuy P.F.C.® Sigma Rotating Platform Knee|no details
12028969|NCT00375843|Drug|Escitalopram|Level 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks.
12028970|NCT00375843|Drug|Sertraline|Level 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks.
12028971|NCT00375830|Procedure|Bone scan|Scan to diagnose a number of bone conditions including cancer or metastasis
12028972|NCT00375830|Drug|99mTc-methyl diphosphonate|Radiolabel for bone scan procedures
12028973|NCT00375830|Procedure|Positron Emission Tomography (PET) scan|Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
12028974|NCT00375830|Drug|18F-Fludeoxyglucose (18F-FDG)|Radiolabel for positron emission tomography scan procedures
12028975|NCT00375830|Procedure|Computed Tomography (CT) scan|Scan to detect & analyze X-rays
12028976|NCT00375830|Drug|18F-Sodium Fluoride (18F-NaF)|Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.
12028977|NCT00375830|Procedure|Whole Body Magnetic Resonance Imaging (WB-MRI) scan|Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.
12028978|NCT00375830|Drug|Gadopentetate dimeglumine|A gadolinium-based contrast agent for MRI
12028979|NCT00375830|Drug|Gadofosveset|A gadolinium-based contrast agent for MRI
12028980|NCT00375830|Drug|Gadobutrol|A gadolinium-based contrast agent for MRI
12028981|NCT00375817|Procedure|Myoblasts injection with MyoCath catheter|
12028982|NCT00375791|Drug|perifosine|100 - 150 mg daily
12028983|NCT00375791|Drug|dexamethasone|20 mg twice weekly
12028984|NCT00375778|Drug|memantine (drug)|
12028985|NCT00375765|Drug|Dutasteride|
12028986|NCT00375752|Drug|Letrozole|2.5 mg.tablet.
12028987|NCT00375752|Drug|Zolendronic Acid|4 mg or an adjusted dose based on renal function in 100 ml physiologic (o.9%) normal saline, (as an intravenous infusion over no less than 15 minutes)
12028988|NCT00375739|Drug|PEP005|
12028989|NCT00375726|Biological|rDEN3/4delta30(ME)|Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses)
12028990|NCT00375726|Biological|Placebo|Placebo for rDEN3/4delta30(ME)
12028991|NCT00375713|Drug|Levocetirizine|1 Levocetirizine 5mg tablet per day before bedtime for 14 days
12028992|NCT00375713|Drug|Cetirizine|1 Cetirizine 10mg tablet per day before bedtime for 14 days.
12028993|NCT00375713|Drug|Placebo-Levocetirizine|1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
12028994|NCT00375713|Drug|Placebo-Cetirizine|1 Placebo-Cetirizine tablet per day before bedtime for 14 days
12028995|NCT00375713|Drug|Standard topical steroid (1% hydrocortisone) ointment|1% hydrocortisone ointment, applied 2-3 times a day to all affected areas
12028996|NCT00375700|Dietary Supplement|Nutritional Supplement|
12028997|NCT00375687|Drug|Triptorelin|
12028998|NCT00375674|Drug|Sunitinib malate|sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
12028999|NCT00375674|Other|Placebo|Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent
12029000|NCT00375661|Drug|interferon-alfa-2b and ribavirin|Interferon, pnce per week plus daily ribavirin
12029001|NCT00375648|Drug|Zoledronic acid|
12029002|NCT00375635|Procedure|mFPSA treatment|
12029003|NCT00375622|Drug|Tamoxifen|
12029004|NCT00375609|Drug|Betrixaban|Capsule
12029005|NCT00375609|Drug|Enoxaparin|Administered subcutaneously
12029006|NCT00375596|Drug|Ketotifen/vasoconstrictor|
12029009|NCT00375557|Drug|Divalproex ER|Divalproex ER will be initiated on 250 mg/day, dosed once daily. The daily dose of Divalproex ER will be titrated up 250 mg each day based on patients' response and tolerability, not to exceed a maximum of 2000 mg/day.
12029010|NCT00375557|Drug|Quetiapine|Quetiapine will be initiated in 25 mg/day, with a variable dosing frequency (QD-TID). The daily dose of Quetiapine will be titrated up by 25-50 mg each day based on patients' response and tolerability, not to exceed a maximum of 750 mg/day.
12029011|NCT00375544|Device|Low level light therapy|
12029012|NCT00375531|Behavioral|Mindfulness Meditation (MfM)|
12029013|NCT00375518|Drug|Atorvastatin|Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
12029014|NCT00375518|Drug|Placebo|Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
12029015|NCT00375505|Drug|Zoledronic acid|
12029016|NCT00375505|Drug|Placebo|Placebo
12029017|NCT00375492|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
12029018|NCT00375492|Drug|placebo|subcutaneous injection, volume equivalent to exenatide dose, twice a day
12029019|NCT00375466|Drug|Tranexamic acid|Tranexamic acid 10 mg/kg as a bolus dose followed by an infusion of 1 mg/kg/hour. Bolus given before start of surgery, infusion continued during surgery.
12029020|NCT00375466|Drug|placebo|0.9% sodium chloride 10 mg/kg, as a bolus injection before surgery followed by 1 mg/kg/h as an infusion during surgery
12029021|NCT00375453|Drug|SH U04722|
12029022|NCT00375440|Drug|Tranexamic Acid|
12029023|NCT00375427|Drug|Zoledronic acid|Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.
12029024|NCT00375414|Procedure|PEG-Gastropexy|
12029025|NCT00375401|Drug|CP-945,598 Treatment A|Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
12029026|NCT00375401|Drug|CP-945,598 Treatment B|Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
12029027|NCT00375401|Drug|Placebo|Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
12029028|NCT00375388|Drug|Metformin on top of intensive insulin therapy|
12029029|NCT00375375|Drug|Lactulose|
12029030|NCT00375362|Drug|Nitroderm patch|
12029031|NCT00375349|Procedure|Ultrasound to demonstrate existence of fatty liver|
12029032|NCT00375323|Drug|NovoSeven|
12029033|NCT00375310|Drug|Gemcitabine, Sorafenib|"Gemcitabine is given IV
~Sorafenib is given orally of varying doses:
~Sorafenib 200 mg po qd ( during combination therapy)
~Sorafenib 400 mg po qd ( during combination therapy)
~Sorafenib 400 mg po bid ( during combination therapy)"
12029034|NCT00375310|Procedure|Radiotherapy|1.8 Gy CTV daily for 5 weeks
12029035|NCT00375297|Drug|sildenafil|
12029036|NCT00375284|Drug|Pramipexole|
12029037|NCT00375271|Procedure|perioperative hemodynamic optimization protocol|
12029038|NCT00375258|Drug|Tranexamic acid|Loading dose of 1 gram then 1 gram by infusion over 8 hours
12029039|NCT00375258|Drug|Sodium Chloride 0.9%|Visual matched placebo
12029040|NCT00375245|Drug|Rapamycin (sirolimus)|Weekly oral doses, dose is assigned at the time of study entry
12029041|NCT00375245|Other|Grapefruit Juice|Daily oral doses starting during the second week on study.
12029042|NCT00375232|Drug|Administration of montelukast or placebo|
12029043|NCT00375219|Drug|Omacetaxine mepesuccinate|"Induction:
~1.25 mg/m^2 subcutaneously, twice daily for 14 consecutive days every 28 days until response. Patients not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.
~Maintenance:
~1.25 mg/m^2 subcutaneously, twice daily for 7 consecutive days in a 28-day cycle, for up to 3 years."
12029044|NCT00375206|Biological|Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)|
12029045|NCT00375193|Drug|Amrubicin|Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial
12029046|NCT00375167|Behavioral|Recovery Workbook Training (psychoeducational training)|The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.
12029047|NCT00375167|Behavioral|ACT as usual|Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
12029048|NCT00375154|Device|Noninvasive Positive-Pressure Ventilation (NPPV)|
12029049|NCT00375141|Device|Pulsed dye laser, Intense pulsed light|
12029050|NCT00375128|Biological|FP9-PP (FP9 polyprotein)|
12029051|NCT00375128|Biological|MVA-PP (Modified Virus Ankara polyprotein)|
12029052|NCT00375115|Drug|Sambucol|
12029053|NCT00375102|Procedure|Acupuncture|
12029054|NCT00375102|Behavioral|Relaxation Response|
12029055|NCT00375089|Other|Group 1|Individuals with Prader-Willi syndrome. Monitoring every 6 months.
12029056|NCT00375089|Other|Group 2|Individuals with Early-onset Morbid Obesity.
12029057|NCT00375076|Drug|enoxaparin|
12029058|NCT00375063|Procedure|Percutaneous Coronary Intervention|
12029059|NCT00375063|Procedure|Coronary Artery Bypass Grafting|
12029060|NCT00375050|Drug|Riluzole|
12029061|NCT00375050|Drug|Placebo|placebo
12029062|NCT00375037|Behavioral|feedback|
12029063|NCT00375037|Behavioral|Education|
12029064|NCT00375037|Other|usual care|
12029065|NCT00375024|Procedure|Patient Navigation|Inclusion of Patient Navigator in treatment plan.
12029066|NCT00375024|Procedure|Clinic Staff|Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.
12029067|NCT00374998|Biological|FP9-PP (FP9 polyprotein)|
12029068|NCT00374998|Biological|MVA-PP (Modified Virus Ankara polyprotein)|
12029072|NCT00374959|Device|Endotracheal tube for aspiration of subglottic secretions.|
12029073|NCT00374946|Device|THA|
12029074|NCT00374933|Drug|Non-myeloablative allogeneic stem cell transplant with prophylactic activated DLI|"Prophylactic delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation"
12029075|NCT00374933|Drug|"Prophylactic delayed ADLI"|"Prophylactic ADLI after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation"
12029076|NCT00374933|Drug|"Prophylactic delayed activated donor lymphocyte infusion"|"Prophylactic delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation"
12029077|NCT00374920|Drug|MEM 1003|
12029078|NCT00374907|Drug|Saxagliptin|Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
12029079|NCT00374907|Drug|Placebo|Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
12029080|NCT00374907|Drug|Metformin (blinded)|Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
12029081|NCT00374907|Drug|Metformin (open-label)|Tablets, Oral, 500-1500 mg, as needed (starting in LT)
12029082|NCT00374894|Drug|2,3-dimercaptosuccinic acid|
12029083|NCT00374881|Drug|Morphine|Morphine
12029084|NCT00374881|Drug|Morphine|Morphine low dose
12029085|NCT00374881|Drug|Sorbitol+Phenylephrine|Sorbitol+Phenylephrine
12029086|NCT00374881|Drug|Sorbitol+Phenylephrine+Morphine|Sorbitol+Phenylephrine+Morphine
12029087|NCT00374881|Drug|Sorbitol low concentration+Phenylephrine+Morphine|Sorbitol low concentration+Phenylephrine+Morphine
12029088|NCT00374868|Drug|pemetrexed|"Phase 1: 300 mg/m^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles (dose escalation: 300 mg/m^2, 400 mg/m^2, and 500 mg/m^2)
~Phase 2: phase 1 determined dose, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy"
12029089|NCT00374868|Drug|cisplatin|"Phase 1: 50 mg/m^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles
~Phase 2: 50 mg/m^2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy"
12029090|NCT00374855|Drug|PPAR alpha|
12029091|NCT00374855|Drug|Hydrochlorothiazide|
12029092|NCT00374855|Drug|Placebo|
12029093|NCT00374842|Biological|Fluarix™|GlaxoSmithKline Biologicals' licensed influenza vaccine
12029094|NCT00374842|Biological|GSK1247446A|Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
12029095|NCT00374829|Behavioral|An IT-based patient follow-up and reminder system|
12029096|NCT00374803|Drug|Mycophenolic Acid (Myfortic)|"Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
~Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
12029097|NCT00374790|Drug|Ferrous sulfate|
12029098|NCT00374777|Drug|zolpidem MR|oral
12029099|NCT00374777|Drug|nitrazepam|oral
12029100|NCT00374777|Drug|placebo|oral
12029101|NCT00374764|Drug|Risperidone|
12029102|NCT00374764|Behavioral|ABA|
12029103|NCT00374751|Drug|Samarium (153SM)|The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon.
12029104|NCT00374738|Behavioral|Guided Imagery for Trauma (GIFT)|Guided Imagery for Trauma (GIFT) - music and voice narration over a 12-week intervention. The control intervention included a relaxing music audio (the same music used in the guided imagery audio but without the narrative voiceover), PDA to log audio use, orientation and weekly phone consults, but did not have access to the patient advocate or to the guided imagery instructions provided on the GIFT audio.
12029105|NCT00374725|Behavioral|Administration of probiotic (L. rhamnosus and L. acidophilus)|
12029106|NCT00374699|Drug|Velcade|
12029107|NCT00374686|Drug|Valganciclovir|
12029108|NCT00374673|Device|Repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation of the motor cortex (10 Hz) every day during 5 days then every week for 3 weeks then every two weeks for 2 months then every month for 3 additional months
12029109|NCT00374660|Drug|Irofulven + oxaliplatin|"Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle. Starting dose 40 mg/m^2, dose escalation 50, 60, 70, and 80 mg/m^2 every 28 days if no dose-limiting toxicity.
~Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered in a 30-minute infusion on Days 1 and 15 of a 28-day cycle. Starting dose 0.30 mg/kg, dose escalation to 0.40 mg/kg every 28 days if no dose-limiting toxicity."
12029110|NCT00374647|Drug|mycophenolate mofetil|
12029111|NCT00374647|Drug|sirolimus|
12029112|NCT00374634|Drug|rFSH drug dose|"Individual rFSH dose (50, 75 or 100 IU rFSH/day)"
12029113|NCT00374634|Drug|"Standard rFSH dose"|"Standard rFSH dose was 75 IU/day"
12029114|NCT00374621|Drug|Misoprostol with or without isosorbide mononitrate|Misoprostol 50 micrograms orally then 100 micrograms every 4 hours for up to four doses until modified Bishop score of 8 or higher was observed vs. the same misoprostol dosing plus isosorbide mononitrate 40 mg vaginally every 6 hours up to two doses total until a modified Bishop sore of at least 8 was observed
12029115|NCT00374582|Device|Bodystat Quadscan 4000|device determining body composition and nutritional status
12029116|NCT00374582|Device|bodystat quadscan 400|device determining body composition and nutritional status
12029117|NCT00374569|Procedure|Gymnastic Routine|A combination of gymnastic movements are performed
12029118|NCT00374556|Drug|Placebo|3mg placebo capsule, once daily at bedtime
12029119|NCT00374556|Drug|Eszopiclone|3mg capsule, once daily at bedtime
12029120|NCT00374543|Drug|Ziprasidone|Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
12029121|NCT00374543|Drug|Placebo|Placebo administered daily for 8 weeks
12029122|NCT00374530|Drug|PGE2|
12029123|NCT00374517|Drug|Pimonidazole hydrochloride|
12029124|NCT00374478|Drug|Scopolamine|
12029125|NCT00374465|Drug|Verapamil|
12029126|NCT00374465|Drug|Carvedilol|
12029127|NCT00374452|Other|ATHENA-CDS-HTN plus Guideline Link|ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
12029128|NCT00374452|Other|Guideline Link Only|Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.
12029129|NCT00374439|Behavioral|Cognitive-behavioral|Cognitive-behavioral approach
12029130|NCT00374439|Behavioral|Interpersonal Therapy|Interpersonal therapy approach
12029131|NCT00374426|Drug|sertraline|
12029132|NCT00374413|Device|Artificial disk|Implant
12029133|NCT00374413|Device|Artificial disc|Implant
12029134|NCT00374387|Drug|Nuvaring|
12029135|NCT00374387|Drug|low-dose combination pill|
12029136|NCT00374387|Drug|minipill|
12029137|NCT00374374|Behavioral|Administration of probiotic|
12029138|NCT00374348|Drug|Aripiprazole|Abilify, 5mg; 10mg; 15mg; 20mg; 30mg
12029139|NCT00374335|Procedure|abdominal ultrasound|abdominal ultrasound to detect hepatic hemangiomas
12029140|NCT00374335|Other|Dermatologic Examination|Complete dermatologic examination
12029141|NCT00374322|Drug|lapatinib|Lapatinib 1500 mg (6 tablets) daily for 12 months
12029142|NCT00374322|Other|placebo|6 tablets daily for 12 months
12029143|NCT00374309|Drug|VRC-EBOADV018-00-VP|
12029144|NCT00374296|Drug|MGCD0103|MGCD0103 administered orally three-times per week
12029145|NCT00374270|Behavioral|Lifestyle Counselling; Opinion Leader Influence Statements|
12029146|NCT00374257|Procedure|Narrow-Band UVB Phototherapy|Performed either two or three times per week for a total of 24 treatments
12029147|NCT00374244|Drug|Pimozide|half of the subjects are randomized to the active drug group
12029148|NCT00374244|Drug|placebo|half of the subjects are randomized to placebo group
12029149|NCT00374231|Drug|tacrolimus|Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
12029150|NCT00374231|Drug|mycophenolate mofetil|Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
12029151|NCT00374231|Drug|Prednisone|Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
12029152|NCT00374218|Drug|High Fructose Corn Syrup|
12029153|NCT00374218|Drug|Sucromalt|
12029154|NCT00374205|Drug|Artesunate plus Amodiaquine|Artesunate 50 mg and Amodiaquine 153 mg co-blister tablets: 3 days once daily weight-adjusted dosing according to manufacturer
12029155|NCT00374205|Drug|Artemether-Lumefantrine|Artemether 20 mg/Lumefantrine 120mg fixe-dose-combination tablets: 3 days twice daily weight-adjusted dosing according to manufacturer
12029156|NCT00374192|Drug|Eszopiclone|3 mg per day
12029157|NCT00374192|Drug|Placebo|Placebo
12029158|NCT00374179|Drug|CT-322|IV solution, weekly or bi-weekly
12029159|NCT00374166|Drug|SSR149415|Oral administration (capsules of 50 and 100 mg)
12029160|NCT00374166|Drug|Placebo|Oral administration (capsules)
12029161|NCT00374166|Drug|Paroxetine|Oral administration (capsules)
12029162|NCT00374153|Behavioral|Feedback|Online personal feedback report
12029163|NCT00374153|Behavioral|Motivational Interview with Feedback|In-person Motivational Interview with personal feedback report
12029164|NCT00374153|Behavioral|Motivational Interview|In-person Motivational Interview only (without a personal feedback report)
12029165|NCT00374140|Drug|RAD001 (everolimus)|10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
12029166|NCT00374127|Drug|Marijuana blunt|Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).
12029167|NCT00374127|Drug|marijuana cigarette|Marijuana cigarettes were provided by the National Institute on Drug Abuse.
12029168|NCT00374114|Procedure|cervical conization|
12029169|NCT00374114|Procedure|ultrasonic surgical aspiration of the cervix|
12029170|NCT00374101|Drug|omeprazole|
12029171|NCT00374101|Drug|pantoprazole|
12029172|NCT00374088|Drug|N-acetylcysteine|"Loading dose: Subjects randomized to IV NAC will receive a total loading dose of 100 mg/kg of 10% (100 mg/mL) solution. Acetadote is supplied as a 20% solution (200 mg/mL) and will be diluted 1:1 with an equal volume of D5W. The volume of the loading dose will be 1 mL/kg, anticipated to be 2.5-5 mL in our patient population. The loading dose will be administered over 1 hr beginning 1 hr prior to the patient's OR time. Subjects in the placebo group will receive 1 mL/kg of D5W over 1 hr.
~Maintenance infusion: Subjects randomized to IV NAC will receive an infusion of 10 mg/kg/hr of 10% (100 mg/mL) solution for 24 hrs, starting in the OR after weaning from CPB. Acetadote is supplied as a 20% solution (200 mg/mL) and will be diluted 1:1 with an equal volume of D5W. The volume of the maintenance infusion will be 0.1 mL/kg/hr, anticipated to be 0.25-0.5 mL/hr in our patient population. Subjects in the placebo group will receive 0.1 mL/kg/hr of D5W for 24 hrs."
12029173|NCT00374088|Drug|Placebo|D5W bolus prior to surgery and D5W infusion after surgery in an equal volume to the drug arm.
12029174|NCT00374075|Drug|Valproic Acid|
12029175|NCT00374062|Behavioral|relaxation therapy 1|relaxation therapy 1
12029176|NCT00374062|Behavioral|relaxation therapy 2|relaxation therapy 2
12029177|NCT00374062|Behavioral|relaxation therapy 3|relaxation therapy 3
12029178|NCT00374049|Drug|MUC_1|Pretreatment with Poly-ICLC alone week 1 &2 (50 ug/kg 3 days/week) Weeks 3-7 Poly-ICLC, 2 days/week; MUC-1 vaccine (100ug) admixed with GM-CSF (100ug), administered subcutaneously at weeks 3, 5 and 7 Tetanus toxoid, administered via intramuscular injection, 1x at week 3 GM-CSF 100ug, administered subcutaneously on days 2-4
12029179|NCT00374036|Drug|ECC|capecitabine
12029180|NCT00374036|Drug|FOLFIRI|Irinotecan
12029181|NCT00374023|Drug|Zinc, or Vitamin A or both|
12029182|NCT00374010|Behavioral|Patient-Centered Advance Care Planning|"The PC-ACP is a scheduled interview with the dyad, delivered by a trained nurse facilitator. It consists of 5 stages and lasts about an hour:
~Representational assessment (10 - 15 minutes);
~Exploring concerns related to planning for future medical decision-making (10 - 15 minutes);
~Creating conditions for conceptual change (5 minutes);
~Introducing replacement information using a disease-specific Statement of Treatment Preferences document (15 minutes); and
~Summary (3 - 5 minutes)"
12029183|NCT00373997|Procedure|Esophageal and Laryngeal biopsies|one day procedure
12029184|NCT00373997|Procedure|egd with biopsy|standard of care procedure with biopsy
12029185|NCT00373971|Behavioral|Involving the patients in their own nutritional care|
12029186|NCT00373958|Biological|13 valent pneumococcal conjugate vaccine|1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
12029187|NCT00373958|Biological|7vPnc pneumococcal conjugate vaccine|1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
12029188|NCT00373945|Drug|Observational Study|
12029189|NCT00373932|Behavioral|Coached exercise persistence intervention|Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.
12029190|NCT00373932|Behavioral|Self-Monitored exercise persistence intervention|Self-monitoring of symptoms and exercise using a mobile device
12029191|NCT00373919|Drug|intravenous (IV) administration of erythromycin|
12029192|NCT00373906|Drug|Bortezomib (Velcade)|
12029193|NCT00373893|Drug|Lidoderm Patch|
12029194|NCT00373880|Drug|Aripiprazole + Cocaine|Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
12029195|NCT00373880|Drug|Placebo + Cocaine|Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
12029196|NCT00373867|Behavioral|Standard physical therapy|Treatment-based classification physical therapy
12029197|NCT00373867|Behavioral|Graded exercise|Graded exercise increases an individual's tolerance to activity over time
12029198|NCT00373867|Other|Graded exposure|Graded exposure places the individual in fearful situations and gradually increases their exposure to such situations.
12029199|NCT00373815|Drug|Everolimus|
12029200|NCT00373802|Drug|Phenylephrine|
12029201|NCT00373789|Drug|Botulinum Toxin A, bladder detrusor muscle injection|200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.
12029202|NCT00373789|Drug|Vehicle saline as placebo|A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices
12029203|NCT00373776|Drug|miltefosine 2.5 mg/kg/day for 28 days|
12029204|NCT00373763|Procedure|Fetoscopic tracheal balloon occlusion|
12029205|NCT00373750|Procedure|Family Spirit Intervention|The Family Spirit Intervention was developed over a decade through community-based participatory research.The intervention content included 43 structured lessons and followed a culturally congruent format.
12029206|NCT00373724|Procedure|radiofrequency denervation|
12029207|NCT00373711|Drug|Iodine-124|2 mCi, oral
12029208|NCT00373711|Drug|Iodine-123|2 mCi, oral
12029209|NCT00373711|Drug|F-18 FDG|10-15 mCi, iv
12029210|NCT00373698|Behavioral|Three Component Model of Collaborative Care|Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
12029211|NCT00373685|Drug|Celecoxib|open-label
12029212|NCT00373685|Drug|Any commercially available NSAID with the indication for osteoarthritis|dosing as per USPI label related to the chosen commercially marketed NSAID
12029213|NCT00373672|Drug|armodafinil (Nuvigil)|armodafinil (Nuvigil)150 mg qd
12029214|NCT00373672|Drug|placebo|identical in appearance to active comparator
12029215|NCT00373659|Drug|Ranibizumab (Lucentis)|
12029216|NCT00373646|Drug|Thalidomide, Pharmion|200 mg p.o. daily
12029217|NCT00373633|Procedure|Thoracic Epidural|Gold standard for post thoracotomy pain
12029218|NCT00373633|Procedure|Extrapleural Intercostal Catheter|Continuous extra-pleural intercostal local anesthesia
12029219|NCT00373620|Drug|paclitaxel|
12029220|NCT00373607|Drug|Dihydroartemisin-piperaquine|Dihydroartemisin-piperaquine (Artekin) manufactured by Hualijian Pharmaceutical Co. Ltd., Guangzhou, China. Each tablet contains 40mg of dihydroartemisinin and 320mg piperaquine
12029221|NCT00373607|Drug|Mefloquine + Artesunate|Mefloquine + Artesunate (MAS3). The regimen is artesunate 4 mg/kg/day once daily for 3 days plus mefloquine 24 mg/kg given as a three day regimen of 8mg/kg/day
12029222|NCT00373594|Drug|Rituximab|
12029223|NCT00373594|Drug|Fludarabine|
12029224|NCT00373581|Drug|Vigabatrin|
12029225|NCT00373581|Drug|Cocaine|
12029226|NCT00373568|Drug|miltefosine: 2.5 mg/kg/day for 42 days|
12029227|NCT00373555|Procedure|Bronchoscopy|
12029228|NCT00373542|Drug|ropinirole CR-RLS|
12029229|NCT00373529|Drug|clofarabine|"Induction cycle 1: cycle 1 of clofarabine 30 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.
~Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days."
12029230|NCT00373516|Drug|Vehicle (Placebo) applied BID|
12029231|NCT00373516|Drug|QRX-101 75 mcg/g ointment applied QD|
12029232|NCT00373516|Drug|QRX-101 75 mcg/g ointment applied BID|
12029233|NCT00373503|Drug|Lofexidine|alpha 2 adrenergic agonist, hypothesized to decrease noradrenergic activity
12029234|NCT00373503|Drug|dronabinol|cannabinoid agonist hypothesized to decrease MJ withdrawal
12029235|NCT00373503|Drug|Marijuana|marijuana intoxication, withdrawal and relapse assessed
12029236|NCT00373490|Drug|Vorinostat|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
12029237|NCT00373490|Drug|Vorinostat|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
12029238|NCT00373477|Procedure|Generalist Care Manager vs Usual Care|
12029239|NCT00373464|Drug|etoricoxib|
12029240|NCT00373451|Drug|Abciximab + UFH|Abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125 µg/kg/minute [maximum of 10 µg/minute] infusion for 12 hours)
12029241|NCT00373451|Drug|Bivalirudin|Bivalirudin (intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure)
12029242|NCT00373451|Drug|Heparin|i.v. bolus of 70 units/kg/body weight of unfractionated heparin
12029454|NCT00372034|Device|Temporary Collagen Inserts|
12029243|NCT00373438|Procedure|Fetoscopic tracheal balloon occlusion|Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes
12029244|NCT00373425|Drug|Erlotinib|150 mg tablet
12029245|NCT00373425|Drug|Placebo|Placebo tablet
12029246|NCT00373412|Biological|VCL CT02 pDNA vaccine|
12029247|NCT00373412|Biological|Towne CMV vaccine|
12029248|NCT00373399|Drug|Inactive Marijuana (0% THC)|Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
12029249|NCT00373399|Drug|Low THC marijuana (1.8 %THC)|Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
12029250|NCT00373399|Drug|High THC marijuana (3.9% THC)|Active marijuana (3.9%) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
12029251|NCT00373386|Drug|growth hormone|Growth Hormone treatment
12029252|NCT00373373|Drug|Sorafenib|2 x 400 mg/d
12029253|NCT00373373|Drug|Placebo|Chemotherapy + Placebo
12029254|NCT00373360|Drug|treprostinil sodium|rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump
12029255|NCT00373334|Drug|nizatidine (axid)|nizatidine (axid)
12029256|NCT00373334|Drug|nizatidine (axid)|nizatidine (axid)
12029257|NCT00373334|Drug|placebo|placebo
12029258|NCT00373295|Drug|Baclofen|Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
12029259|NCT00373295|Drug|Marijuana|Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.
12029260|NCT00373295|Drug|Placebo|
12029261|NCT00373282|Drug|Triamcinolone acetonide|
12029262|NCT00373256|Drug|Sunitinib|Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
12029263|NCT00373256|Drug|paclitaxel|Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
12029264|NCT00373256|Drug|bevacizumab|Bevacizumab 10 mg/kg IV every 2 weeks.
12029265|NCT00373256|Drug|paclitaxel|Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
12029266|NCT00373243|Drug|GW406381|GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.
12029267|NCT00373230|Behavioral|telemedicine|One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
12029268|NCT00373217|Biological|MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine|Given intradermally or subcutaneously
12029269|NCT00373217|Biological|tetanus toxoid helper peptide|Given intradermally or subcutaneously
12029270|NCT00373217|Drug|carboplatin|Given IV
12029271|NCT00373217|Drug|paclitaxel|Given IV
12029272|NCT00373217|Procedure|conventional surgery|Patients undergo primary optimal cytoreductive surgery
12029273|NCT00373204|Drug|Motexafin Gadolinium|"On Day 1 of each 3 week cycle for up to 12 cycles:
~MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour."
12029274|NCT00373191|Drug|chemotherapy|N/A- not dictated by study
12029275|NCT00373191|Drug|endocrine therapy|N/A- not dictated by study
12029276|NCT00373191|Genetic|DNA methylation analysis|laboratory analysis
12029277|NCT00373191|Genetic|protein analysis|laboratory analysis
12029278|NCT00373191|Other|laboratory biomarker analysis|laboratory analysis
12029279|NCT00373191|Other|questionnaire administration|questionnaire
12029280|NCT00373191|Procedure|adjuvant therapy|N/A- not dictated by study
12029281|NCT00373191|Procedure|conventional surgery|N/A- not dictated by study
12029282|NCT00373191|Radiation|radiation therapy|N/A- not dictated by study
12029283|NCT00373178|Drug|rosiglitazone|
12029284|NCT00373178|Drug|metformin|
12029285|NCT00373178|Drug|Anti-diabetic medications|
12029286|NCT00373165|Drug|Ganciclovir|
12029287|NCT00373152|Procedure|Lumpectomy|Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.
12029288|NCT00373152|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.
12029289|NCT00373152|Procedure|radiofrequency ablation|RFA is accomplished by placing a multi-array needle within a tumor. The tines of the needle are advanced and opened like an inverted umbrella. High frequency, alternating current moves from the tip of an electrode into the surrounding tissue. Oscillating ions generate frictional heat within the tumor. Cell death occurs at sustained temperatures above 45-50 degrees C. The multi-array configuration creates an egg-shaped ablation zone up to 5 cm in diameter.
12029290|NCT00373152|Radiation|gadopentetate dimeglumine|Injected at baseline MRI and post radiofrequency ablation MRI.
12029291|NCT00373126|Drug|transdermal nicotine patch|
12029292|NCT00373113|Drug|Capecitabine|1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
12029293|NCT00373113|Drug|Sunitinib malate|37.5 mg daily, continuous dosing
12029294|NCT00373100|Drug|Zinc acetate|
12029295|NCT00373100|Drug|Placebo|Placebo
12029296|NCT00373087|Drug|entacapone|entacapone
12029297|NCT00373087|Drug|l dopa versus placebo|l dopa versus placebo
12029298|NCT00373074|Other|Epidural Blood Patch|Use 15 cc of blood
12029299|NCT00373074|Other|Epidural Blood Patch|Inject 20 cc of blood into epidural space
12029300|NCT00373074|Other|Epidural Blood Patch|Inject 30 cc of autologous blood
12029455|NCT00372021|Procedure|optic nerve neurotomy|
12029301|NCT00373061|Drug|Xolair®|This being an observational study, the study protocol does not specify any dose regimen.
12029302|NCT00373048|Drug|mefloquine|tablet, once weekly
12029303|NCT00373048|Drug|placebo|tablet, once weekly
12029304|NCT00373035|Genetic|proteomic profiling|
12029305|NCT00373035|Other|immunological diagnostic method|
12029306|NCT00373035|Other|laboratory biomarker analysis|
12029307|NCT00373035|Other|mass spectrometry|
12029308|NCT00373035|Procedure|biopsy|
12029309|NCT00373035|Procedure|ultrasound imaging|
12029310|NCT00373022|Behavioral|exercise intervention|
12029311|NCT00373022|Other|flow cytometry|
12029312|NCT00373022|Other|laboratory biomarker analysis|
12029313|NCT00373022|Procedure|management of therapy complications|
12029314|NCT00373022|Procedure|psychosocial assessment and care|
12029315|NCT00373022|Procedure|quality-of-life assessment|
12029316|NCT00373009|Behavioral|Traditional Army training|As usual training for Soldiers
12029317|NCT00373009|Behavioral|Core stabilization exercise only|Core stabilization exercise
12029318|NCT00373009|Behavioral|Psychosocial education class only|Psychosocial education class
12029319|NCT00373009|Behavioral|Core stabilization and psychosocial education|Includes both core stabilization training and psychosocial education class
12029320|NCT00372996|Drug|CP-751,871|CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
12029321|NCT00372996|Drug|exemestane|Exemestane given at 25 mg orally once a day.
12029322|NCT00372996|Drug|exemestane|Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity
12029323|NCT00372996|Drug|Fulvestrant|Used for salvage therapy and administered according to the local label and standard clinical practice.
12029324|NCT00372983|Drug|NOV-205|
12029325|NCT00372970|Drug|Botulinum toxin A|200 U given by injection into the pylorus.
12029326|NCT00372970|Drug|Placebo|saline injection into pylorus.
12029327|NCT00372957|Drug|GW823093 15mg|White opaque capsule containing 15mg of GW823093 as free base
12029328|NCT00372957|Drug|GW823093 placebo capsule|Matching placebo of GW823093 capsule or 15mg capsule
12029329|NCT00372957|Drug|GW823093 30mg|White opaque capsule containing 15mg of GW823093 as free base
12029330|NCT00372944|Drug|AZD6244|oral capsule
12029331|NCT00372944|Drug|capecitabine|oral tablet
12029332|NCT00372931|Drug|AL-37807|
12029333|NCT00372918|Procedure|Transnasal Esophagoscopy|fiberoptic exam of esophagus thru nares
12029334|NCT00372905|Drug|rituximab|Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
12029335|NCT00372905|Drug|bortezomib|Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
12029336|NCT00372905|Drug|Ibritumomab tiuxetan|Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
12029337|NCT00372892|Drug|Rituximab|375mg/m2 per week for 4 consecutive weeks
12029338|NCT00372892|Drug|Placebo|Saline IV placebo once per week for 4 consecutive weeks
12029339|NCT00372879|Dietary Supplement|Vitamin E|Vitamin E 800IU bid
12029340|NCT00372853|Drug|CP-675,206|CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
12029341|NCT00372853|Drug|SU011248|SU011248 administered at a dose of 37.5mg/day every day.
12029342|NCT00372853|Drug|CP-675,206|CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
12029343|NCT00372853|Drug|SU011248|SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
12029344|NCT00372840|Other|educational intervention|
12029345|NCT00372840|Procedure|psychosocial assessment and care|
12029346|NCT00372840|Procedure|quality-of-life assessment|
12029347|NCT00372827|Drug|Brinzolamide 1% added to Travoprost 0.004%|
12029348|NCT00372814|Behavioral|Intensive Home-Based Family Therapy|Multisystemic Therapy (MST): Adolescents receiving MST will receive home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their dilay diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.
12029349|NCT00372814|Behavioral|Supportive Telephone Calls|Telephone Support Calls: Adolescents receiving TS will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.
12029350|NCT00372801|Drug|Ibuprofen|
12029351|NCT00372788|Drug|AZD6244|oral vial
12029352|NCT00372788|Drug|Pemetrexed|oral
12029353|NCT00372775|Drug|Sunitinib|Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity
12029354|NCT00372762|Drug|Furosemide|Current dose of furosemide will be maintained and equivalent dose bumetanide will be used following crossover
12029355|NCT00372762|Drug|Bumetanide|Equivalent dose to pre-existing furosemide will be used
12029356|NCT00372762|Drug|furosemide|20mg to 80mg orally once or twice daily
12029357|NCT00372762|Drug|bumetanide|0.5mg to 2mg orally once or twice daily
12029358|NCT00372749|Behavioral|Aversive reaction during alcohol cue exposure|Aversive reaction during alcohol cue exposure
12029456|NCT00372008|Drug|Testosterone|
12029359|NCT00372736|Drug|AEG35156|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
12029360|NCT00372736|Drug|docetaxel|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
12029361|NCT00372736|Genetic|protein expression analysis|Cycle 1: Pre-dose on Days -2, 1, 8 and 15; repeat every 2-4 days if LFTs > 5 x ULN1 Cycle 2: Prior to each infusion; repeat every 2-4 days if LFTs > 5 x ULN1
12029362|NCT00372736|Genetic|reverse transcriptase-polymerase chain reaction|Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
12029363|NCT00372736|Other|flow cytometry|Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
12029364|NCT00372736|Other|immunoenzyme technique|Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
12029365|NCT00372736|Other|immunohistochemistry staining method|The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).
12029366|NCT00372736|Other|laboratory biomarker analysis|The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).
12029367|NCT00372723|Drug|Remicaide (infliximab)|a single dose infusion of 5mg/kg Remicade (Infliximab)
12029368|NCT00372710|Drug|Zoledronic acid|
12029369|NCT00372697|Drug|Octreotide acetate 30 mg suspension|Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.
12029370|NCT00372684|Genetic|with severe malaria hospitalized in ICU|with severe malaria hospitalized in ICU
12029371|NCT00372684|Genetic|with uncomplicated malaria|with uncomplicated malaria
12029372|NCT00372671|Behavioral|Survey|
12029373|NCT00372671|Behavioral|Survey and videotape|
12029374|NCT00372658|Drug|1% Lidocaine intracervical injection|
12029375|NCT00372645|Dietary Supplement|Folic acid (supplement)|200 µg folate per day from supplemental folic acid
12029376|NCT00372645|Dietary Supplement|Metafolin (supplement)|200 µg folate per day from supplemental Metafolin®
12029377|NCT00372645|Drug|Placebo|Placebo
12029378|NCT00372645|Other|Folate rich foods|200 µg folate per day from folate-rich foods
12029379|NCT00372632|Drug|Sulfadoxine-Pyrimethamine|The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
12029380|NCT00372632|Drug|placebo|The control group receives placebo similar in taste and appearance to to the experimental arm
12029381|NCT00372619|Drug|clofarabine|Given IV for 5 days
12029382|NCT00372619|Drug|cytarabine|Given IV
12029383|NCT00372619|Drug|methotrexate|Given intrathecally or IT age based dosage
12029384|NCT00372619|Other|laboratory biomarker analysis|
12029385|NCT00372606|Behavioral|Online MiDieta Diet and Weight Management Program for Hispanics|
12029386|NCT00372593|Drug|asparaginase|Given intramuscularly
12029387|NCT00372593|Drug|cytarabine|Given IV
12029388|NCT00372593|Drug|daunorubicin hydrochloride|Given IV over 6 hours
12029389|NCT00372593|Drug|etoposide|Given IV over 1-4 hours
12029390|NCT00372593|Drug|gemtuzumab ozogamicin|Given IV over 2 hours
12029391|NCT00372593|Drug|mitoxantrone hydrochloride|Given IV over 1 hour
12029392|NCT00372580|Procedure|blood test|
12029393|NCT00372567|Drug|sunitinib malate|37.5 mg daily
12029394|NCT00372567|Drug|imatinib mesylate|800mg daily
12029395|NCT00372541|Drug|ceftriaxone|
12029396|NCT00372528|Drug|pregabalin (LYRICA)|150 mg up to a maximum of 600 mg per day bid or tid as required
12029397|NCT00372515|Drug|Gefitinib|On days 1-14 gefitinib will be taken orally daily at either 750, 1000, or 1250mg (depends upon when subject entered trial). If medication is tolerated well, subject will take 500mg daily on days 15-28 of each 28-day cycle. Cycles (higher dose followed by lower dose) will be repeated as long as subject's cancer does not worsen and they do not experience any serious side effects.
12029398|NCT00372502|Procedure|Modified EGDT|Early goal directed therapy with lactate clearance
12029399|NCT00372502|Procedure|Standard EGDT|Early goal directed therapy
12029400|NCT00372489|Drug|peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
12029401|NCT00372476|Drug|Imatinib and Vinorelbine|
12029402|NCT00372463|Behavioral|6-week Online Diabetes Self-Management Educational Program|
12029403|NCT00372450|Procedure|management of therapy complications|
12029404|NCT00372450|Procedure|quality-of-life assessment|
12029405|NCT00372437|Drug|MGCD0103|MGCD0103 as an oral dose three times per week.
12029406|NCT00372437|Drug|Gemcitabine|Gemcitabine 1000mg/m<2> intravenously days 1, 8, 15 of a 28 day cycle.
12029407|NCT00372424|Drug|Herceptin|Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.
12029565|NCT00371046|Procedure|Transvaginal ultrasound cervical length|
12029566|NCT00371046|Procedure|Cervicovaginal fetal fibronectin|
12029408|NCT00372424|Drug|Sunitinib|SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.
12029409|NCT00372424|Drug|Taxotere|The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
12029410|NCT00372411|Device|Robot-Assisted Therapy - MIT-MANUS System|The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.
12029411|NCT00372411|Other|Intensive Comparison Therapy|The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).
12029412|NCT00372411|Other|Usual Care|The usual chronic stroke care as delivered at each participating medical center
12029413|NCT00372385|Drug|Ribavirin|tablet
12029414|NCT00372385|Drug|Pegylated Interferon Alfa 2a|Solution for injection
12029415|NCT00372385|Drug|Placebo|tablet
12029416|NCT00372385|Drug|Telaprevir|tablet
12029417|NCT00372372|Drug|risedronate|
12029418|NCT00372346|Procedure|Transplantation of autologous endothelial progenitor cells|
12029419|NCT00372333|Drug|IDEA-033|
12029420|NCT00372320|Genetic|Gene Transfer|
12029421|NCT00372320|Drug|AdhAQP1|
12029422|NCT00372307|Drug|Application of pimecrolimus|
12029423|NCT00372294|Drug|pyrimethamine-sulfadiazine + prednisolone|Administration of pyrimethamine-sulfadiazine + prednisolone
12029424|NCT00372294|Drug|Clindamycin+Dexamethasone|Intravitreal injection of Clindamycin+Dexamethasone
12029425|NCT00372281|Drug|Cliavist|Injection of 0,9 mL (weight < 60kg) or 1,4 mL (weight > 60kg) of Cliavist (ferucarbotran) by direct intraveinous way, 48 h following the MRI done with gadolinium.
12029426|NCT00372268|Device|Aeroneb® Pro (Nektar® Company)|The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.
12029427|NCT00372268|Device|Aeroneb® Pro (Nektar® Company)|The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
12029428|NCT00372255|Biological|Influsplit SSW® 2005/2006|Study influenza vaccine was administered intramuscularly in the non-dominant arm
12029429|NCT00372242|Behavioral|Prospective Longitudinal Interventional Stury|
12029430|NCT00372229|Drug|Valganciclovir CMV Prophylaxis|900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
12029431|NCT00372229|Drug|Valganciclovir (Pre-emptive CMV Therapy)|If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
12029432|NCT00372229|Drug|Ganciclovir|If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
12029433|NCT00372216|Drug|Clopidogrel (Iscover/Plavix)|Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible
12029434|NCT00372203|Procedure|Endobronchial Ultrasound Guided Transthoracic Needle Biopsy|Endobronchial Ultrasound Guided Transthoracic Needle Biopsy of mediastinal lymph nodes at the time of the mediastinoscopy.
12029435|NCT00372190|Device|Tensionfree vaginal mesh kit (Prolift)|Insertion of a tension free vaginal mesh using a Prolift mesh kit
12029436|NCT00372190|Procedure|classic vaginal prolapse surgery (fascia plication)|classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
12029437|NCT00372177|Radiation|Fab-fragment of Anti-human CD4|Sterile lyophilized Powder for Preparation of a Solution and sterile labelling Buffer labelling with Tc99m-Pertechnetat Intravenous injection
12029438|NCT00372164|Procedure|American Society of Interventional Pain Physician Guidelines|
12029439|NCT00372151|Dietary Supplement|L-Theanine|400 mg/day, caps.
12029440|NCT00372151|Other|Placebo|caps.
12029441|NCT00372138|Procedure|PRP + autologous thrombin|simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms
12029442|NCT00372125|Drug|Norditropin SimpleXx|0.3-0.4 mg/day placebo or GH for 4 weeks. Thereafter 0.6-0.8 mg/day placebo or GH for 11 months. During the following 24 months open phase doses will be individually titrated.
12029443|NCT00372112|Drug|GW642444|GW642444H
12029444|NCT00372112|Other|Placebo|Placebo administered twice daily
12029445|NCT00372099|Drug|Salmon calcitonin|nasal salmon calcitonin 200UI/day during 2 years
12029446|NCT00372086|Drug|Rosiglitazone|
12029447|NCT00372073|Drug|seliciclib|1200 mg bid x 3 days every 2 weeks
12029448|NCT00372073|Drug|placebo|1200 mg bid x 3 days every 2 weeks
12029449|NCT00372060|Drug|sitagliptin phosphate|Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
12029450|NCT00372060|Drug|Comparator: sitagliptin phosphate (MK0431)|Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
12029451|NCT00372060|Drug|Comparator: pioglitazone|pioglitazone once daily for 52 weeks
12029452|NCT00372060|Drug|Comparator: placebo (unspecified)|Placebo once daily for 12 weeks
12029453|NCT00372047|Device|multiphoton laser imaging|
12029457|NCT00371995|Drug|Liposomal amphotericin B and Miltefosine|"Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
~Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)"
12029458|NCT00371982|Drug|Fish oil (Maxepa)|
12029459|NCT00371969|Behavioral|Enhanced Motivational Interview|The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system).
12029460|NCT00371969|Behavioral|Standard Motivational Interview or viewing DVD|Brief motivational interview, viewing a DVD on HIV self-care.
12029461|NCT00371956|Drug|raloxifene|60mg/day
12029462|NCT00371956|Drug|placebo|tab 1 daily
12029463|NCT00371943|Procedure|band ligation|
12029464|NCT00371930|Procedure|application of a dye suspension followed by a laser intervention|
12029465|NCT00371904|Drug|Rituximab|Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation
12029466|NCT00371904|Drug|Standard Care|Standard care
12029467|NCT00371891|Procedure|Multidetector Computed Tomography Coronary Angiography|1 Multidetector Computed Tomography Coronary Angiography
12029468|NCT00371878|Biological|7-valent pneumococcal conjugate vaccine (Prevnar)|
12029469|NCT00371865|Behavioral|Cognitive-behavioral therapy|8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
12029470|NCT00371865|Behavioral|Acceptance-based therapy|8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
12029471|NCT00371852|Drug|lactoserum|
12029472|NCT00371839|Procedure|Audiological Evaluation|Tests of hearing, cognition, and speech perception
12029473|NCT00371826|Drug|Everolimus (RAD001)|
12029474|NCT00371826|Drug|Cyclosporine (Calcineurin Inhibitor (CNI))|
12029475|NCT00371826|Drug|Methylprednisone/prednisone|
12029476|NCT00371826|Drug|Mycophenolate sodium (MPA)|
12029477|NCT00371813|Drug|Varenicline tartrate|
12029478|NCT00371813|Drug|Placebo|
12029479|NCT00371800|Drug|cinnamon|
12029480|NCT00371787|Device|Soft contact lens|Soft contact lens
12029481|NCT00371761|Biological|Pegylated interferon alfa-2b (PegIntron)|Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
12029482|NCT00371761|Drug|Adefovir dipivoxil (adefovir)|10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks
12029483|NCT00371748|Device|TAXUS Liberté-SR|Paclitaxel-Eluting Coronary Stent, 2.25 mm
12029484|NCT00371748|Device|TAXUS™ Express2|Paclitaxel-Eluting Coronary Stent System
12029485|NCT00371748|Device|Express2|Coronary Stent System
12029486|NCT00371735|Drug|chlorproguanil-dapsone-artesunate|
12029487|NCT00371735|Drug|chlorproguanil-dapsone|
12029488|NCT00371722|Procedure|Appendectomy|
12029489|NCT00371709|Device|TAXUS Liberté-SR|Paclitaxel-Eluting Coronary Stent System
12029490|NCT00371709|Device|TAXUS™ Express|Paclitaxel-Eluting Coronary Stent System
12029491|NCT00371696|Drug|diclofenac|
12029492|NCT00371696|Drug|paracetamol|
12029493|NCT00371696|Device|heat retaining knee support|
12029494|NCT00371696|Device|standard knee support|
12029495|NCT00371683|Drug|Enoxaparin + Placebo|Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
12029496|NCT00371683|Drug|Apixaban + Placebo|Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
12029497|NCT00371670|Drug|balicatib (AAE581)|
12029498|NCT00371644|Behavioral|Cognitive Processing Therapy|CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
12029499|NCT00371644|Behavioral|Present-Centered Therapy|PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
12029500|NCT00371631|Biological|Insertion of urinary catheters coated with E. coli 83972|All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
12029501|NCT00371618|Procedure|Fluoroscopy|
12029502|NCT00371592|Drug|Acyclovir|800 mg tablet taken orally twice daily
12029503|NCT00371592|Drug|Acyclovir placebo|800 mg placebo tablet taken orally twice daily
12029504|NCT00371579|Drug|rosuvastatin|
12029505|NCT00371566|Drug|Lapatinib oral tablets|
12029506|NCT00371566|Drug|Placebo|
12029507|NCT00371553|Drug|SU011248 (Sunitinib)|
12029508|NCT00371540|Other|Home visit by community care coordinators|Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.
12029509|NCT00371527|Drug|ipratropium|
12029510|NCT00371501|Drug|Rosuvastatin|10mg/day
12029511|NCT00371501|Drug|placebo|one tablet/day
12029512|NCT00371501|Drug|aspirin|80mg/day
12029513|NCT00371501|Drug|placebo|placebo
12029514|NCT00371488|Drug|GW572016 oral tablets|Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.
12029515|NCT00371475|Device|TAXUS Liberté-SR|Paclitaxel-Eluting Coronary 38 mm Stent
12029516|NCT00371475|Device|TAXUS™ Express|Paclitaxel-Eluting Coronary Stent System
12029567|NCT00371033|Drug|Pregabalin|dosage
12029568|NCT00371033|Drug|Placebo|dosage
12029569|NCT00371020|Drug|low molecular weight heparin, 5-FU|
12029570|NCT00371007|Drug|MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks|
12029517|NCT00371462|Behavioral|Use of PDA + support to reduce weight and pain|participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months.
12029518|NCT00371462|Behavioral|MOVE! level 2 group weight loss counseling|Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months.
12029519|NCT00371436|Procedure|Progressive Audiologic Tinnitus Management|The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
12029520|NCT00371436|Procedure|Usual Care|Typical audiologic care that would be received in a VA Audiology Clinic.
12029521|NCT00371423|Device|TAXUS Liberté™-SR|Paclitaxel-Eluting Coronary Stent System
12029522|NCT00371423|Device|TAXUS Liberté™-SR|Paclitaxel-Eluting Coronary Stent System
12029523|NCT00371410|Procedure|vitrectomy|
12029524|NCT00371410|Drug|intravitreal triamcinolone acetonide|
12029525|NCT00371410|Procedure|macular focal laser photocoagulation|
12029526|NCT00371397|Behavioral|Hatha Yoga Classes|Iyengar yoga, the form of hatha yoga used in this study, emphasizes the use of props to help students achieve precise postures safely and comfortably according to their particular body types and needs. The yoga activity sessions were directed by four experienced yoga teachers following a script. The poses used were (in order) Supta Baddha Konasana (Reclining Bound Angle Pose), Adho Mukha Svanasana (Downward Facing Dog), Supported Uttanasana (Intense Forward Stretch), Parsvotanasana (Intense Side Stretch Pose), Prasarita Padottanansana (Wide-Legged Forward Bend), Janu Sirsasana (Head to Knee Pose), Bharadvajasana (Simple Seated Twist Pose), Viparita Karani (Restful Inversion), Supported Setu Bandha Sarvanagasana (Bridge Pose), and Savasana (Corpse Pose). Blood draws occurred during the last two minutes of Supta Baddha Konasana (pose held 10 minutes), Viparita Karani (10 minutes), and Savasana (15 minutes).
12029527|NCT00371397|Behavioral|Movement Control|Walking on a treadmill at .5 miles per hour was used to control for general physical movement/cardiovascular expenditure because it best approximated the heart rates during the restorative yoga session. To match the lower heart rate, women also rested supine on a bed for several minutes after walking, before and after getting their blood drawn.
12029528|NCT00371384|Procedure|massage|UP to 10 massages over 10 weeks
12029529|NCT00371371|Procedure|Bone marrow punction|A total volume of 100 ml bone marrow will be aspirated from the iliac crest under local anaesthesia (lidocaine) according to local routine. To maximise the patients comfort, 5-10 mg midazolam and 50 ug fentanyl will be administered intravenously.
12029530|NCT00371371|Procedure|BM-MNC infusion|Repeated intra-arterial infusion of autologous BM-MNC into the common femoral artery
12029531|NCT00371371|Procedure|Placebo infusion|Repeated intra-arterial infusion of placebo (PBS/4% HAS/heparin, coloured with autologous erythrocytes to match the colour of BM-MNC suspension) into the common femoral artery.
12029532|NCT00371345|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average <6 months)
12029533|NCT00371345|Drug|Dasatinib 100 mg|Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months)
12029534|NCT00371332|Drug|Minocycline HCL Microspheres|
12029535|NCT00371319|Drug|tacrolimus|0.06-0.1 mg/kg/day
12029536|NCT00371319|Drug|mycophenolate mofetil|2-3 gm/day
12029537|NCT00371306|Drug|Insulin versus glucovance (glyburide/metformin)|
12029538|NCT00371293|Behavioral|Weight Loss Program|Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
12029539|NCT00371293|Device|CPAP therapy|Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
12029540|NCT00371280|Procedure|orbital implant|Implantation of pegged versus unpegged hydroxyapatite orbital implants
12029541|NCT00371267|Behavioral|Telephone-delivered Cognitive Behavior Therapy|Telephone-delivered cognitive behavior therapy for pain management
12029542|NCT00371267|Other|Telephone-delivered Patient Education|Telephone-delivered patient education regarding chronic pain
12029543|NCT00371254|Drug|Dasatinib|Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg <6 months)
12029544|NCT00371254|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg <6 months)
12029545|NCT00371228|Procedure|Delay of umbilical cord clamping|Umbilical cord delayed until pulsation stops.
12029546|NCT00371215|Biological|rThrombin|1000 U/mL applied topically
12029547|NCT00371202|Procedure|keratoplasty|
12029548|NCT00371189|Drug|Placebo|Normal saline.
12029549|NCT00371189|Biological|Ad35.CS.01 Circumsporozoite Malaria Vaccine|Adenovirus Type 35 Circumsporozoite Malaria Vaccine (Ad35.CS.01); administered at 0, 1, and 6 months; dosage levels: 10^8 viral particles (vp)/mL, 10^9 vp/mL, 10^10 vp/mL and 10^11 vp/mL.
12029550|NCT00371176|Behavioral|Exposure therapy|A manualized form of treatment that involves vividly visualizing indexed trauma with the guidance of a therapist
12029551|NCT00371176|Drug|D-Cycloserine|A partial NMDA agonist that has been shown in human trials to facilitate and strengthen extinction with CBT.
12029552|NCT00371176|Other|Placebo pill|
12029553|NCT00371150|Drug|Entecavir|Tablets, Oral, 0.5 mg, once daily, up to 52 weeks
12029554|NCT00371137|Drug|Xyrem®|two doses
12029555|NCT00371137|Drug|Placebo|Oral Solution
12029556|NCT00371124|Drug|Atropine Eye drops|
12029557|NCT00371111|Drug|Intravitreal injection of Triamcinolone|4 mg of Triamcinolone
12029558|NCT00371111|Drug|Intravitreal injection of Avastin|Injection of 1.25 mg of Avastin and
12029559|NCT00371098|Biological|Influenza vaccination: Influvac (SolvayPharma)|
12029560|NCT00371098|Biological|placebo influenza vaccine|
12029561|NCT00371085|Behavioral|education|Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction
12029562|NCT00371072|Procedure|trabeculectomy with mitomycin-C|
12029563|NCT00371059|Drug|Memantine|Memantine 10mg BD
12029564|NCT00371059|Drug|Placebo|Placebo 10 mgs BD
12029571|NCT00371007|Drug|Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks|
12029572|NCT00370994|Procedure|Caudal epidural injection|Caudal epidural injection with catheterization
12029573|NCT00370994|Procedure|Percutaneous adhesiolysis|Percutaneous adhesiolysis with hypertonic saline neurolysis
12029574|NCT00370981|Drug|pagoclone|
12029575|NCT00370968|Drug|Zinc sulphate|
12029576|NCT00370955|Procedure|phacoemulsification using either high vacuum or low vacuum techniques|All surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology.
12029577|NCT00370942|Drug|GW823093C A|A=45 mg
12029578|NCT00370942|Drug|GW823093C B|B=30 mg
12029579|NCT00370942|Drug|GW823093C C|C=25 mg
12029580|NCT00370929|Behavioral|Meditation|
12029581|NCT00370916|Behavioral|Physician-initiated medication reconciliation|Physician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template
12029582|NCT00370916|Behavioral|Pharmacist-initiated medication reconciliation|Pharmacist performed and documented medication reconciliation
12029583|NCT00370890|Drug|Adjuvant chemotherapy (gemcitabine and cisplatin)|Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles
12029584|NCT00370877|Drug|rFVIIa|The patients included in this arm of the study will recieve standard care for post-partum hemorrhage plus a slow intravenous injection (2ml/min) of rFVIIa (60µg/kg)
12029585|NCT00370877|Procedure|Standard Care|Patients will recieve standard care for post partum hemorrhage according to current recommendations.
12029586|NCT00370864|Biological|H5N1 pandemic influenza vaccine|
12029587|NCT00370851|Drug|Avastin (Bevacizumab)|Intravitreal injection of 125 mg Avastin
12029588|NCT00370838|Drug|Levetiracetam|The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
12029589|NCT00370838|Drug|Clonidine|The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
12029590|NCT00370825|Drug|Combination therapy with AmBisome and miltefosine|
12029591|NCT00370812|Procedure|amniotic membrane transplantation|AMT with conventional medical therapy (group A) or medical treatment only (group B). AMT will be performed within 24h of presentation. Amniotic membrane will remain in place for 7-14 days.
12029592|NCT00370799|Drug|Caudal epidural injection|group 1: Caudal epidural injection local anesthetics only
12029593|NCT00370799|Drug|Caudal Epidural Injection with generic Celestone|Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
12029594|NCT00370799|Drug|Caudal Epidural Injection with Celestone|Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
12029595|NCT00370799|Drug|Caudal Epidural Injection with DepoMedrol|Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
12029596|NCT00370786|Drug|bevacizumab|
12029597|NCT00370773|Device|Precision Spinal Cord Stimulation System|
12029598|NCT00370760|Drug|oral colchicine, dexamethasone, low molecular weight heparin, 5-FU|
12029599|NCT00370760|Drug|placebo|
12029600|NCT00370747|Drug|Ecabet|ophthalmic solution 2.83%
12029601|NCT00370747|Drug|Ecabet|ophthalmic solution 3.70%
12029602|NCT00370747|Drug|Placebo|
12029603|NCT00370734|Drug|Botulinum toxin A injection|
12029604|NCT00370721|Drug|bevacizumab|
12029605|NCT00370708|Procedure|Oral Intake following admittance to the postpartum ward|
12029606|NCT00370695|Device|Precision Spinal Cord Stimulation System|Stimulation turned on from implant throughout the Study
12029607|NCT00370682|Biological|T-DEN F17|A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
12029608|NCT00370682|Biological|T-DEN F-19|A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
12029609|NCT00370682|Other|Placebo Comparator|A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
12029610|NCT00370669|Drug|bevacizumab|
12029611|NCT00370669|Drug|triamcinolone acetonide|
12029612|NCT00370656|Drug|Pregabalin|capsule, 150mg bd, 300mg bd
12029613|NCT00370656|Drug|Duloxetine|Capsule, 60mg on, 60mg bd
12029614|NCT00370656|Drug|Amitriptyline|Capsule. 25 mg bd, 25 mg om and 50 mg on
12029615|NCT00370643|Drug|human regular insulin|
12029616|NCT00370630|Drug|Avastin (Bevacizumab) and triamcinolone|
12029617|NCT00370617|Drug|metformin|
12029618|NCT00370604|Device|19g Tuohy-type epidural needle, 23g catheter|Patients in the experimental group will receive a 23g 90cm adult length epidural catheter placed via a 19g Tuohy epidural needle (SIMS Portex, Hythe, UK). The 19g Tuohy needle is a standard 3½ inch length.
12029619|NCT00370604|Device|=> 18g Tuohy-type needle|Patients in the control arm will receive a traditional large gauge (16g, 17g or 18g Tuohy or Hustead) epidural needle and a traditional epidural catheter. Two control needles and two control catheters will be designated apriori by each institution for use in the study.
12029620|NCT00370591|Drug|Salmeterol/fluticasone propionate and fluticasone propionate|
12029621|NCT00370578|Device|repeated thrombus aspiration during primary PCI|
12029622|NCT00370565|Drug|Inhaled Human Insulin|
12029670|NCT00370097|Drug|FLOVENT (fluticasone propionate) HFA|FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.
12029778|NCT00369317|Other|laboratory biomarker analysis|Correlative studies
12029623|NCT00370552|Drug|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
12029624|NCT00370552|Drug|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m^2 was to be implemented for all subsequent cycles.) Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
12029625|NCT00370552|Drug|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
12029626|NCT00370539|Drug|verteporfin, bevacizumab, triamcinolone acetonide|
12029627|NCT00370526|Procedure|Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement|
12029628|NCT00370513|Drug|pazopanib|Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.
12029629|NCT00370500|Drug|Quetiapine fumarate|Dosage and frequency are judged by the study physician. The dosage must not excess 800mg/d.
12029630|NCT00370474|Device|Bi-ventricular lead placement|
12029631|NCT00370448|Behavioral|school-based social support system|Training gatekeeper recruited from students and tutors and counselors for group 1; training counsellors for group 2; No special intervention for group 3
12029632|NCT00370435|Drug|GW274150|
12029633|NCT00370422|Drug|Triamcinolone, Bevacizumab|
12029634|NCT00370409|Procedure|Cryotherapy|Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.
12029635|NCT00370396|Biological|Synflorix|1 dose injected IM in the right thigh or deltoid.
12029636|NCT00370396|Biological|Prevenar|1 dose injected IM in the right thigh or deltoid.
12029637|NCT00370396|Biological|Infanrix hexa|1 dose injected IM in the right thigh or deltoid.
12029638|NCT00370383|Drug|Erlotinib|erlotinib 150 mg/day once daily
12029639|NCT00370383|Drug|Satraplatin|"satraplatin 100 mg/m2 orally once daily for 5 consecutive days (days 1-5)followed by erlotinib 150mg/day for 14 consecutive days (days 8-21).
~Satraplatin JM-216, bis-aceto-ammine dischlorocyclohexylamine platinum)is a third-generation platinum analogue with activity following oral administration. The molecular formula for satraplatin is C10H22N2Cl2O4Pt, which is structured as an octahedral platinum compound."
12029640|NCT00370370|Drug|bevacizumab|Injection of intravitreal bevacizumab
12029641|NCT00370370|Drug|bevacizumab + triamcinolone acetonide|Injection of bevacizumab + triamcinolone acetonide
12029642|NCT00370357|Drug|3% w/w SPL7013 Gel (VivaGel™)|
12029643|NCT00370344|Procedure|Laparoscopic cholecystectomy|Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
12029644|NCT00370344|Procedure|Small-incision open cholecystectomy|Operation by experts in small-incision open cholecystectomy.
12029645|NCT00370331|Drug|eltrombopag|Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down.
12029646|NCT00370331|Drug|Placebo|Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down
12029647|NCT00370318|Biological|10 valent pneumococcal conjugate vaccine|
12029648|NCT00370318|Biological|Infanrix Hexa|
12029649|NCT00370318|Biological|Rotarix|
12029650|NCT00370318|Drug|Paracetamol|
12029651|NCT00370305|Drug|rosiglitazone|89 mg BID for 8 weeks, orally
12029652|NCT00370292|Drug|Pemetrexed - Before Protocol Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
12029653|NCT00370292|Drug|Pemetrexed - After Protocol Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
12029654|NCT00370279|Procedure|scleral buckling, primary vitrectomy|Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
12029655|NCT00370266|Drug|Triamcinolone|
12029656|NCT00370253|Drug|Terlipressin|1mg/4 h per day
12029657|NCT00370253|Drug|Noradrenalin|0,1 mcg/kg/min
12029658|NCT00370240|Drug|Chlorhydrate de Ropivacaine|The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)
12029659|NCT00370240|Other|placebo|The PCB group received saline solution in equal volume.
12029660|NCT00370227|Biological|10 valent pneumococcal conjugate (vaccine)|
12029661|NCT00370201|Drug|colchicine|
12029662|NCT00370188|Drug|Topiramate|
12029663|NCT00370162|Drug|lactoserum|
12029664|NCT00370149|Device|Antibiotic-impregnated Catheters (M/R)|Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
12029665|NCT00370149|Device|Non-impregnated Catheters (C/S)|Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
12029666|NCT00370136|Drug|ultrasound contrast|
12029667|NCT00370110|Drug|Itopride 100 mg|100 mg three times daily
12029668|NCT00370110|Other|Placebo|
12029669|NCT00370110|Drug|Itopride 200 mg|200 mg three times daily
12029671|NCT00370097|Drug|Placebo HFA|Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
12029672|NCT00370084|Drug|Itopride|oral, three times daily
12029673|NCT00370084|Other|Placebo|oral, three times daily
12029674|NCT00370071|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
12029675|NCT00370058|Procedure|ECT treatment|
12029676|NCT00370045|Drug|Bivalirudin with and without eptifibatide|
12029677|NCT00370032|Drug|alosetron|
12029678|NCT00370019|Drug|Estradiol/Medroxyprogesterone acetate|
12029679|NCT00370006|Biological|Towne CMV vaccine|
12029680|NCT00369993|Drug|fluticasone propionate/salmeterol|
12029681|NCT00369967|Drug|NuvaRing|Initiation of NuvaRing for contraception
12029682|NCT00369954|Drug|carboplatin|
12029683|NCT00369954|Drug|gemcitabine hydrochloride|
12029684|NCT00369941|Drug|MK-0518|400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks
12029685|NCT00369941|Drug|Comparator: efavirenz|600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks
12029686|NCT00369941|Drug|Comparator: Truvada|One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
12029687|NCT00369941|Drug|Comparator: Placebo to MK-0518|Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks
12029688|NCT00369941|Drug|Comparator: Placebo to efavirenz|Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
12029689|NCT00369928|Drug|PG-760564|100 mg BID, of oral PG-760564
12029690|NCT00369928|Drug|Placebo dose|placebo, BID, oral for 12 weeks
12029691|NCT00369928|Drug|PG-760564|25 mg BID, of oral PG-760564
12029692|NCT00369915|Drug|Scopolamine|
12029693|NCT00369915|Drug|Scopolamine|
12029694|NCT00369902|Procedure|acupuncture|
12029695|NCT00369889|Drug|bevacizumab|iv every 21 days
12029696|NCT00369889|Drug|Erlotinib|oral daily
12029697|NCT00369863|Drug|Triamcinolone acetonide|
12029698|NCT00369850|Other|laboratory biomarker analysis|Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
12029699|NCT00369850|Procedure|Dual energy X-ray absorptiometry (DEXA)|Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
12029700|NCT00369850|Procedure|Spine X-ray|Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
12029701|NCT00369837|Drug|clevidipine|Clevidipine was required to be administered continuously for a minimum of 18 hours and a maximum of 96 hours and was not to exceed a rate of 32.0 mg/h at any time. Use of an additional or alternative intravenous antihypertensive agent was allowed if the blood pressure target range was not achieved or maintained. If transition to an oral antihypertensive agent is required, then approximately 1 hour prior to the anticipated cessation of clevidipine infusion, but no less than at the 18-hour time point, an oral antihypertensive agent was allowed to be administered as clevidipine was down-titrated or terminated as needed in order to achieve the desired blood pressure level..
12029702|NCT00369824|Biological|Different formulations of GSK Biologicals' HPV vaccine (580299)|Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
12029703|NCT00369824|Biological|Menactra TM|One dose of vaccine administered intramuscularly
12029704|NCT00369824|Biological|Boostrix TM|One dose of vaccine administered intramuscularly
12029705|NCT00369811|Drug|Oxycodone, fentanyl|
12029706|NCT00369798|Procedure|PET scan|
12029707|NCT00369798|Drug|Rolipram|
12029708|NCT00369785|Drug|donepezil hydrochloride|Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
12029709|NCT00369785|Drug|Placebo|Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
12029710|NCT00369772|Drug|darbepoetin alfa|
12029711|NCT00369759|Other|Emergency Dept. Subjects with LRI or Apnea|No intervention; Epidemiological Study
12029712|NCT00369746|Drug|citalopram|tablets, 60 mg maximum, daily, 12 weeks
12029713|NCT00369733|Drug|Darbepoetin alfa|Darbepoetin alfa adminstered SC every other week to acheive a Hb not to exceed 12 g/dL
12029714|NCT00369720|Procedure|Titration of oxygen in delivery room|
12029715|NCT00369707|Drug|Rituximab|On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
12029716|NCT00369707|Drug|bortezomib|On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
12029717|NCT00369694|Drug|Terlipressin|2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
12029718|NCT00369694|Drug|Terlipressin & then Dummy|2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.
12029719|NCT00369681|Drug|Bleomycin|
12029720|NCT00369681|Biological|Rituximab|
12029721|NCT00369681|Drug|Dacarbazine|
12029722|NCT00369681|Drug|Doxorubicin|
12029723|NCT00369681|Drug|Vinblastine|
12029724|NCT00369668|Behavioral|Bilateral movements and neuromuscular electrical stimulation|Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.
12029774|NCT00369317|Drug|daunorubicin hydrochloride|Given IV
12029775|NCT00369317|Drug|cytarabine|Given IV or IT
12029776|NCT00369317|Drug|thioguanine|Given orally
12029777|NCT00369317|Drug|etoposide|Given IV
12030122|NCT00366392|Device|Optical Aids|
12029725|NCT00369668|Behavioral|Bilateral movements and neuromuscular electrical stimulation|Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
12029726|NCT00369668|Behavioral|Bilateral movements and sham electrical stimulation|Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.
12029727|NCT00369655|Biological|ziv-aflibercept|
12029728|NCT00369642|Behavioral|Cognitive-behavioral therapy|
12029729|NCT00369629|Drug|Gemcitabine|Patients will be treated in cohorts of 3-6 per cohort. The starting dose of gemcitabine will be 800 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 1200 mg/m^2.
12029730|NCT00369629|Drug|Pemetrexed|Patients will be treated in cohorts of 3-6 per cohort. The starting dose of pemetrexed will be 400 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 500 mg/m^2.
12029731|NCT00369616|Biological|CYT002-NicQb|
12029732|NCT00369603|Drug|Razadyne ER|4-weeks 8mg. Razadyne ER, then 4-weeks 16mg. Razadyne ER, and a subsequent 4-weeks of 24mg. Razadyne ER
12029733|NCT00369603|Drug|Aricept|8-weeks 5mg. Aricept and a subsequent 4-weeks of 10mg. Aricept
12029734|NCT00369590|Biological|ziv-aflibercept|Given IV
12029735|NCT00369590|Other|pharmacological study|correlative studies
12029736|NCT00369590|Other|laboratory biomarker analysis|correlative studies
12029737|NCT00369577|Drug|Inhaled Placebo|Inhaled Placebo, single dose
12029738|NCT00369577|Drug|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
12029739|NCT00369577|Drug|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
12029740|NCT00369564|Drug|glutamic acid|Given orally 3 times daily
12029741|NCT00369564|Other|placebo|Given orally 3 times daily
12029742|NCT00369551|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal radiation therapy
12029743|NCT00369551|Drug|paclitaxel|Given IV
12029744|NCT00369551|Biological|bevacizumab|Given IV
12029745|NCT00369551|Drug|carboplatin|Given IV
12029746|NCT00369551|Other|laboratory biomarker analysis|Correlative studies
12029747|NCT00369538|Drug|losartan, hydrochlorothiazide|Two administrations of losartan per day,up to 100mg per day, during 2 months, followed by a wash-out during 1 month, and then one administration of hydrochlorothiazide, 25 mg per day during 2 months
12029748|NCT00369538|Drug|hydrochlorothiazide, losartan|One administration of hydrochlorothiazide, 25 mg per day during 2 months, followed by a wash-out during 1 month, and then, two administrations of losartan per day,up to 100mg per day, during 2 months
12029749|NCT00369512|Drug|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
12029750|NCT00369499|Device|PFO Closure|
12029751|NCT00369486|Procedure|Focal laser photocoagulation|Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study technique)
12029752|NCT00369486|Drug|40mg triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
12029753|NCT00369486|Drug|20mg triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
12029754|NCT00369486|Drug|40mg triamcinolone + laser|Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
12029755|NCT00369486|Drug|20mg triamcinolone + laser|Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser
12029756|NCT00369473|Drug|AMG 108|125 mg via SC (subcutaneous) injection every 4 weeks
12029757|NCT00369473|Drug|AMG 108|250 mg via SC (subcutaneous) injection every 4 weeks
12029758|NCT00369460|Other|physiologic testing|Weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing. Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
12029759|NCT00369447|Procedure|External radiotherapy|Radiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable
12029760|NCT00369447|Biological|nimotuzumab|weekly dose until disease progression
12029761|NCT00369434|Drug|Desvenlafaxine succinate sustained-release (DVS SR)|
12029762|NCT00369408|Drug|Naltrexone|naltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up
12029763|NCT00369408|Drug|placebo|placebo for 12-week treatment period; 3 and 6 months post-treatment follow-up
12029764|NCT00369395|Drug|volociximab|Volociximab, 15 mg/kg, IV infusion once a week for 8 weeks. Subjects who achieved SD or better at Day 50 ± 2 days (Week 8) were eligible to continue receiving weekly infusions of volociximab until disease progression.
12029765|NCT00369382|Drug|cyclosporine or tacrolimus|Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
12029766|NCT00369382|Drug|sirolimus|Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
12029767|NCT00369356|Drug|Prednisone|Bare metal stenting with administration of oral prednisone as described in the protocol
12029768|NCT00369356|Device|Drug eluting coronary stent|Stenting with DES (Cypher or Taxus)
12029769|NCT00369356|Device|Bare metal coronary stent|Stenting with BMS only
12029770|NCT00369343|Drug|Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)|DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
12029771|NCT00369343|Drug|Placebo|Placebo, daily (QD), tablet form, treatment period up to 8 weeks
12029772|NCT00369330|Device|external electrical cardioversion|
12029773|NCT00369317|Drug|asparaginase|Given IM
12029779|NCT00369304|Drug|pharmacokinetic (how the body absorbs and eliminates) interaction|
12029780|NCT00369291|Biological|keyhole limpet hemocyanin|KLH is a foreign protein to humans, it will be used to assess the immune response to a neo-antigen given as a single injection, 1 mg subcutaneously in the arm (per MT1999-06).
12029781|NCT00369291|Biological|tetanus toxoid|Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)
12029782|NCT00369278|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|Tablets for oral administration
12029783|NCT00369265|Drug|Lansoprazole|Lansoprazole 30mg twice daily
12029784|NCT00369265|Dietary Supplement|Sugar pill|placebo twice daily
12029785|NCT00369252|Drug|Nimotuzumab (TheraCIM h-R3)|
12029786|NCT00369239|Drug|risperidone long acting injectable|
12029787|NCT00369226|Drug|Bortezomib (Velcade)|Infusion for a total of 3 doses
12029788|NCT00369226|Drug|Tacrolimus|Taken until Doctor determines it is not necessary any more
12029789|NCT00369226|Drug|Methotrexate|Infusion for a total of 4 doses
12029790|NCT00369226|Procedure|blood stem cell transplantation|Allogeneic Non-myeloablative peripheral blood stem cell transplantation
12029791|NCT00369213|Device|Additional spermicidal lubricant to condoms|
12029792|NCT00369200|Drug|AFP464|Given IV
12029793|NCT00369200|Other|laboratory biomarker analysis|Correlative study
12029794|NCT00369200|Other|pharmacological study|Correlative study
12029795|NCT00369187|Drug|large protein molecule|
12029796|NCT00369174|Drug|rosiglitazone maleate|Given orally
12029797|NCT00369174|Other|laboratory biomarker analysis|Correlative studies
12029798|NCT00369161|Drug|Everolimus (RAD001)|
12029799|NCT00369161|Drug|Tacrolimus|
12029800|NCT00369161|Drug|Basiliximab|
12029801|NCT00369161|Drug|Corticosteroids|
12029802|NCT00369148|Drug|nateglinide(drug) mitiglinide(drug)|
12029803|NCT00369135|Procedure|combined intervention|
12029804|NCT00369122|Biological|Bevacizumab|Given IV
12029805|NCT00369122|Drug|Cisplatin|Given IV
12029806|NCT00369122|Radiation|External Beam Radiation Therapy|Undergo EBRT
12029807|NCT00369122|Radiation|Internal Radiation Therapy|Undergo brachytherapy
12029808|NCT00369109|Other|biologic sample preservation procedure|
12029809|NCT00369109|Other|immunohistochemistry staining method|
12029810|NCT00369109|Other|laboratory biomarker analysis|
12029811|NCT00369109|Procedure|biopsy|
12029812|NCT00369096|Drug|bemiparin 3500 IU/day|
12029813|NCT00369083|Procedure|Hospital at home treatment|
12029814|NCT00369070|Biological|Bevacizumab|15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks
12029815|NCT00369070|Drug|AMG 706|subjects in Arms A and B will take AMG 706 orally in one of two dosing regimens over each 21-day cycle: •Arm A: 125 mg once daily (QD) •Arm B: 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days
12029816|NCT00369070|Drug|Paclitaxel|All subjects will receive a paclitaxel chemotherapy regimen (paclitaxel 200 mg/m2) on day 1 of each 3-week cycle for a maximum of 6 cycles.
12029817|NCT00369070|Drug|Carboplatin|All subjects will receive carboplatin chemotherapy regimen (carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3-week cycle for a maximum of 6 cycles.
12029818|NCT00369044|Drug|prednisone|
12029819|NCT00369031|Biological|Human Immunodeficiency Virus glycoprotein 140 (vaccine)|Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally
12029820|NCT00369031|Biological|HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant|Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant nasally
12029821|NCT00369031|Biological|Labile Toxin mutant LTK63 adjuvant|Labile Toxin mutant LTK63 adjuvant alone
12029822|NCT00369018|Drug|methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)|MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
12029823|NCT00369005|Procedure|Red blood cell transfusion guidelines|
12029824|NCT00368992|Biological|cetuximab|Given IV
12029825|NCT00368992|Drug|paclitaxel|Given IV
12029826|NCT00368992|Biological|bevacizumab|Given IV
12029827|NCT00368979|Drug|Dutasteride|once daily
12029828|NCT00368979|Drug|Placebo|once daily
12029829|NCT00368966|Biological|13-valent Pneumococcal Conjugate Vaccine|
12029830|NCT00368966|Biological|7-valent Pneumococcal Conjugate Vaccine|
12029831|NCT00368953|Device|Yukon Choice stent system|coronary stent implantation
12029832|NCT00368953|Device|Taxus Liberté stent system|coronary stent implantation
12029833|NCT00368940|Behavioral|PATH|PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
12029834|NCT00368940|Behavioral|ST-CI|Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
12029835|NCT00368927|Drug|sulindac|Given orally
12029836|NCT00368927|Other|placebo|Given orally
12029837|NCT00368914|Drug|sirolimus|
12029838|NCT00368914|Other|laboratory biomarker analysis|
12029839|NCT00368914|Other|pharmacological study|
12029840|NCT00368914|Procedure|biopsy|
12029841|NCT00368901|Drug|Darbepoetin alfa|Aranesp administered every other week SC titrated to not exceed Hb 12 g/dL
12029842|NCT00368888|Device|Urine collection bag for infants|
12029843|NCT00368875|Drug|vorinostat|Given orally
12029844|NCT00368875|Drug|paclitaxel|Given IV
12029845|NCT00368875|Biological|bevacizumab|Given IV
12029846|NCT00368862|Drug|Ebixa (memantine hydrochloride)|
12029847|NCT00368862|Drug|Cipralex (escitalopram)|
12029848|NCT00368849|Drug|atomoxetine|This study utilizes a crossover design. Accordingly, half of the participants receive 40 milligram twice a day atomoxetine at arm one while the remaining half receive this intervention at arm two.
12029849|NCT00368849|Drug|Matching Placebo|This study utilizes a crossover design. Accordingly, half of the participants receive twice a day matching placebo at arm one while the remaining half receive this intervention at arm two.
12029850|NCT00368836|Device|BreathScreen PE|One minute of breath collection by tidal breathing into the BreathScreen PE and blood draw for D-dimer level
12029851|NCT00368823|Device|Electronic point-of-care delivery system|
12029852|NCT00368797|Drug|XRP0038 (NV1FGF)|
12029853|NCT00368771|Behavioral|IBS Stress Management|If randomly assigned to this intervention, the session with the therapist will consist of training about IBS symptoms and their relationship to stress, as well as skills training in relaxation and ways of identifying and challenging mistaken thoughts about life events. The goal of this treatment is to lessen mental and physical stressful reactions to daily events, and therefore lessen IBS symptoms as a reaction to stress. The patient will be encouraged to apply relaxation skills to stressful situations.
12029854|NCT00368771|Behavioral|IBS Symptom Management|If assigned to this group, the therapist will discuss feelings, over-attention to IBS symptoms, and your fear of IBS symptoms. Patients will learn how to identify thoughts that may increase your IBS symptoms and will practice how to change these thoughts to ones that make them feel more comfortable. The sessions will focus on reactions to daily life that in turn result in IBS Symptoms.
12029855|NCT00368771|Behavioral|IBS Educational Training|Those assigned to this group will be given educational materials about IBS and will discuss the reading material with the therapist. The reading topics include information on gut disorders, anatomy and physiology of the gut, assessment procedures, and how to manage IBS symptoms. Sessions will also consist of weekly reviews of daily records and IBS symptoms. The goal of this intervention is to provide educational training about IBS.
12029856|NCT00368758|Drug|Probiotic bacteria (Trevis R)|
12029857|NCT00368745|Drug|Pregabalin|GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study.
12029858|NCT00368745|Drug|Placebo|GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.
12029859|NCT00368719|Drug|Tacrolimus|Participants will be followed for 10 years to study the effects of Tacrolimus.
12029860|NCT00368706|Drug|solifenacin succinate|Oral
12029861|NCT00368706|Drug|tolterodine|oral
12029862|NCT00368693|Device|Dermal - Living Skin Replacement (Dermal-LSR)|The only experimental procedure is the application of the study device, Dermal - Living Skin Replacement (Dermal - LSR), to the foot ulcer. All others are regular or standard procedures. Dermal - LSR is a gel containing living human skin cells. This gel is applied directly to ulcers to help repair the skin. The cells used in this study device have come from one foreskin (skin covering the tip of the penis) taken from a baby boy shortly after his birth for reasons unrelated to this study. All cells that will be used have been tested to be healthy and safe. The amount of the study device you will receive depends on the size of your ulcer at each treatment visit. You will receive less than a 1/4 teaspoon of Dermal - LSR for about every dime-size area of your ulcer as measured and calculated by the research investigator.
12029863|NCT00368680|Device|Early Bubble CPAP|
12029864|NCT00368654|Drug|Methotrexate|Initial dose 5 mg, then 15 mg per week
12029865|NCT00368654|Drug|Raptiva|Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
12029866|NCT00368641|Drug|Extraneal|Periotneal Dialysis
12029867|NCT00368628|Procedure|continuous positive airway pressure|Continuous Positive Airway Pressure initiated within 48 hours of stroke onset and continued for 90 days.
12029868|NCT00368602|Drug|Timoptic|Timoptic to be applied to the target wound daily for up to 12 weeks.
12029869|NCT00368602|Other|Placebo|Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.
12029870|NCT00368589|Drug|atorvastatin|
12029871|NCT00368576|Drug|SB 480848, tablets|
12029872|NCT00368563|Drug|Helioblock SX|
12029873|NCT00368550|Drug|Sertraline|Sertraline (to a maximum of 200 mg/day) for 14-week treatment period
12029874|NCT00368550|Drug|Placebo|Placebo for 14-week treatment period
12029875|NCT00368537|Drug|Tigecycline|Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
12029876|NCT00368537|Drug|ampicillin-sulbactam|"Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.
~A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued."
12029877|NCT00368524|Behavioral|contingency management and behavioral day treatment|
12029878|NCT00368511|Procedure|Music Listening|Listen to music and posture measurements
12029879|NCT00368498|Drug|teicoplanin|
12029880|NCT00368485|Device|Neurally Controlled Mechanical Ventilation|A new mode of mechanical ventilation controlled by the electrical activity of the diaphragm (NAVA) will be used before and after extubation.
12029881|NCT00368472|Drug|Perampanel|Perampanel 2 mg to 12 mg, once daily during the OLE study
12029882|NCT00368459|Drug|raloxifene|Raloxifene is a selective estrogen receptor modulator
12029883|NCT00368459|Drug|Placebo|Identical appearing placebo
12029884|NCT00368407|Device|308-nm excimer laser|
12029885|NCT00368394|Drug|Insulin glulisine|
12029886|NCT00368381|Drug|Hydrocortisone|Patients randomized to this arm will receive hydrocortisone for the treatment of adrenal insufficiency secondary to sepsis.
12029887|NCT00368368|Drug|GK Activator (2)|100mg po
12029888|NCT00368355|Drug|Ara-C|"day-8 through day-5
~3 g/m2 q 12 hours"
12029889|NCT00368355|Drug|Cyclophosphamide|"day-7 and day-6
~45 mg/kg"
12029890|NCT00368355|Biological|Campath-1H|"day-3 through day-1
~Dosing for children:
~5 - 15kg : 3mg IV in 30ml NS
~15.1 - 30kg : 5mg IV in 50ml NS
~>30 kg : 10mg IV in 100ml NS
~Adults will receive 10mg IV in 100ml NS"
12029891|NCT00368355|Radiation|Total Body Irradiation|"day-4 through day-1
~175 cGy x 2 at 24 cGy/min"
12029892|NCT00368355|Procedure|Stem Cell Infusion|Stem cells are infused on day 0
12029893|NCT00368342|Drug|Erythromycin, Azithromycin , Clarithromycin|
12029894|NCT00368329|Drug|Capecitabine (Xeloda)|PO bid daily on RT days: 500mg & 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)
12029895|NCT00368329|Drug|[18-F] Fluorodeoxyglucose (FDG)|5-10 mCi IV administration
12029896|NCT00368329|Drug|5-Fluorouracil (5-FU)|200mg/m2 continuous venous infusion
12029897|NCT00368329|Drug|Carboplatin|AUC 2, based onCalvert formula IV infusion
12029898|NCT00368316|Biological|Shigella conjugate vaccines|Shigella sonnei-rEPA and Shigella flexneri2a rEPA vaccines
12029899|NCT00368303|Drug|Paroxetine CR|
12029900|NCT00368303|Drug|Paroxetine IR|
12029901|NCT00368290|Drug|Modafinil|300mg a day for 8 weeks
12029902|NCT00368290|Drug|placebo|placebo pills for 8 weeks
12029903|NCT00368290|Behavioral|Cognitive Behavioral Therapy (CBT)|Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
12029904|NCT00368277|Drug|Aliskiren|Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning
12029905|NCT00368277|Drug|Ramipril|Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning
12029906|NCT00368277|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning
12029907|NCT00368277|Drug|Amlodipine|Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning
12029908|NCT00368264|Drug|infliximab|azathioprine (2 mg/lkg) plus four infusions of infliximab (5mg/kg)
12029909|NCT00368264|Drug|placebo|azathioprine (2 mg/kg) plus four placebo infusions
12029910|NCT00368251|Other|Placebo|"Pharmaceutical Form: Tablet
~Concentration: 2.5 mg, 25 mg and 50 mg
~Route of Administration: Oral use"
12029911|NCT00368251|Drug|BRV 2.5 mg|"Pharmaceutical Form: Tablet
~Concentration: 2.5 mg
~Route of Administration: Oral use"
12029912|NCT00368251|Drug|BRV 25 mg|"Pharmaceutical Form: Tablet
~Concentration: 25 mg
~Route of Administration: Oral use"
12029913|NCT00368251|Drug|BRV 50 mg|"Pharmaceutical Form: Tablet
~Concentration: 50 mg
~Route of Administration: Oral use"
12029914|NCT00368238|Drug|Recombinant human erythropoietin alfa (drug)|
12029915|NCT00368238|Drug|Aspirin (drug)|
12029916|NCT00368238|Drug|Clopidogrel (drug)|
12029917|NCT00368212|Behavioral|Relaxation response training|The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.
12029918|NCT00368212|Behavioral|Psychoeducational counseling|Patients will receive five sessions of psychoeducational counseling from the nurse who works with the primary care physicians. Patients who are interested in continuing treatment or who have not responded to this first treatment step will then be referred for the second step, cognitive behavioral therapy (CBT), for more intensive treatment.
12029919|NCT00368186|Biological|Pneumo 23|
12029920|NCT00368173|Drug|rhIGF-I/rhIGFBP-3|
12029921|NCT00368160|Drug|Eszopiclone|eszopiclone 3 mg
12029922|NCT00368160|Drug|Placebo|Placebo tablet
12029923|NCT00368134|Drug|Vildagliptin|
12029924|NCT00368121|Drug|Cetuximab +/- Dexamethasone|"Cetuximab dosing schedule:
~• Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly over 16 weeks. Mode of administration: intravenous infusion
~Dexamethasone dosing schedule:
~• 20 mg administered on day 1-3, q1w, starting week 5 if evidence of tumor progression or week 9 if no PR or CR to Cetuximab alone.
~Mode of administration: orally"
12029925|NCT00368108|Drug|2 mg perampanel|2 mg perampanel
12029926|NCT00368108|Drug|4 mg perampanel|4 mg perampanel
12029927|NCT00368108|Drug|placebo comparator|placebo comparator
12029928|NCT00368095|Behavioral|Intensive Education for Metabolic Syndrome Patients|Excercise, Intensive diatary program
12029929|NCT00368082|Biological|TGFbeta resistant LMP-specific CTLs|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Group One:
~Day 0 2 x 10^7 cells/m2 Day 14 2 x 10^7 cells/m2
~Group Two:
~Day 0 6 x 10^7 cells/m2 Day 14 6 x 10^7 cells/m2
~Group Three:
~Day 0 1.5 x 10^8 cells/m2 Day 14 1.5 x 10^8 cells/m2"
12029930|NCT00368069|Drug|Keppra® extended release formulation - XR|500mg extended release oral tablet, 2 tablets once daily
12029931|NCT00368069|Drug|Placebo|oral tablets, 2 tablets once daily
12029932|NCT00368056|Drug|Eszopiclone|eszopiclone 3 mg
12029933|NCT00368056|Drug|Placebo|Placebo tablet
12029934|NCT00368030|Drug|Eszopiclone|Eszopiclone 3 mg QD
12029935|NCT00368030|Other|Placebo|Placebo tablet
12029936|NCT00368017|Drug|pioglitazone|30 mg once a day for 12 weeks
12029937|NCT00368017|Drug|placebo|1 pill once a day for 12 weeks
12029938|NCT00367991|Drug|Recombinant human erythropoietin alfa (drug)|200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days
12029939|NCT00367991|Drug|Placebo|Normal saline to match active drug (rHuEpo)
12029940|NCT00367978|Drug|Amlodipine/benazepril|
12029941|NCT00367965|Drug|Eszopiclone|eszopiclone 3 mg
12029942|NCT00367965|Drug|placebo|placebo tablet
12029943|NCT00367952|Drug|apricitabine|800mg apricitabine twice daily orally for 96 weeks
12029944|NCT00367939|Drug|valsartan + amlodipine|
12029945|NCT00367926|Drug|American ginseng root / polysaccharides|
12029946|NCT00367913|Drug|Addition of clarithromycin to rifampicin and ethambutol|
12029947|NCT00367913|Drug|Addition of Ciprofloxacin to rifampicin and ethambutol|
12029948|NCT00367913|Biological|Vaccination with M.vaccae|
12029949|NCT00367887|Drug|Peg-Intron|SC injection, weight based dosing, weekly, 48 weeks
12029950|NCT00367887|Drug|REBETOL|Capsules, weight based dosing, Q12 hrs daily, 48weeks
12029951|NCT00367887|Drug|HCV 796|Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
12029952|NCT00367887|Drug|Peg-Intron|SC injection, weight based dosing, weekly, 48 weeks
12029953|NCT00367887|Drug|REBETOL|Capsules, weight based dosing, Q12 hrs daily, 48weeks
12029954|NCT00367887|Drug|HCV 796|Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
12029955|NCT00367887|Drug|Peg-Intron|SC injection, weight based dosing, weekly, 48 weeks
12029956|NCT00367887|Drug|REBETOL|Capsules, weight based dosing, Q12 hrs daily, 48weeks
12029957|NCT00367874|Drug|Buprenorphine|
12029958|NCT00367874|Drug|Valproate|
12029959|NCT00367861|Drug|interruption of Glivec®|interruption of Glivec®
12029960|NCT00367835|Drug|SPD503 (Guanfacine hydrochloride)|Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
12029961|NCT00367835|Drug|Placebo|Placebo
12029962|NCT00367822|Drug|Lisuride|
12029963|NCT00367822|Drug|Ropinirole|
12029964|NCT00367822|Drug|Placebo|
12029965|NCT00367809|Behavioral|Mindfulness-Based Stress Reduction (MSBR)|Mindfulness-Based Stress Reduction (MBSR) is the intervention of primary interest. It is a psycho-educational program of 8-weekly classes, 2.5 hours long taught by a trained instructor. Over the course of the program participants receive training in several formal meditation techniques: a body-scan meditation, sitting meditation, walking meditation and mindful Hatha yoga that involves simple stretches and movements. Participants are requested to practice meditation at home and to integrate informal mindfulness practices into their daily lives. The content of MBSR is described in the book Full Catastrophe Living by Jon Kabat-Zinn.
12029966|NCT00367809|Behavioral|Health Education (HE)|The active control condition was a peer-led chronic disease self-management program comprised of 8 weekly, 2.5 hour meetings. Led by trained peer-leaders, groups of participants discussed health challenges and problem-solved using a technique called action-planning. The curriculum described by Lorig and colleagues in the book Living a Health Life was the core of this program, and transplant-specific issues were covered in two meetings to match MBSR for time and attention.
12029967|NCT00367809|Behavioral|Delayed Intervention|A temporary wait-list control group; after 6 months, those in the Delayed Intervention were randomized a second time, to one of the active treatment arms (MBSR or HE).
12029968|NCT00367783|Drug|CP-741,952|
12029969|NCT00367770|Drug|Tracleer®|Patients will receive up to 125 mg b.i.d. of Tracleer.
12029970|NCT00367757|Procedure|Ablate AF triggers via PVI|Trigger-based ablation guided by pulmonary vein antrum isolation
12029971|NCT00367757|Procedure|Substrate via CFAEs|Substrate-based ablation using an approach targeting CFAEs
12029972|NCT00367757|Procedure|Combined approach for AF ablation|Combined trigger and substrate based approach
12029973|NCT00367744|Drug|Rosiglitazone|Rosiglitazone 4mg BID
12029974|NCT00367744|Drug|Placebo|Placebo for rosiglitazone
12029975|NCT00367731|Drug|Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI)|
12029976|NCT00367718|Drug|Velcade|velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.
12029977|NCT00367705|Dietary Supplement|VSL#3®|1-2 sachets/day per os, 6 months
12029978|NCT00367705|Dietary Supplement|Placebo|1-2 sachets/day per os, 6 months
12029979|NCT00367692|Drug|PSI-697|
12029980|NCT00367679|Drug|Pazopanib|Pazopanib is an oral, potent, multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit. Subjects were to receive 800 mg oral pazopanib daily for a minimum of 2 weeks to a maximum of 6 weeks.
12029981|NCT00367666|Device|MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)|
12029982|NCT00367653|Drug|Azithromycin plus Chloroquine|Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
12029983|NCT00367653|Drug|Mefloquine|Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
12029984|NCT00367640|Drug|100 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
12029985|NCT00367640|Drug|300 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
12029986|NCT00367640|Drug|500 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
12029987|NCT00367640|Drug|Placebo tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
12029988|NCT00367627|Drug|Albendazole|
12029989|NCT00367614|Drug|pantoprazole|
12029990|NCT00367601|Drug|Erlotinib|Erlotinib 150 mg qd days 1-21
12029991|NCT00367601|Drug|Bevacizumab|Bevacizumab 15 mg/kg IV, day 1
12029992|NCT00367588|Behavioral|Low bacterial diet|
12029993|NCT00367575|Procedure|Internet personalized alcohol feedback (PAF)|
12029994|NCT00367562|Drug|ENALAPRIL VALSARTAN METHYLPREDNISONE|
12029995|NCT00367549|Dietary Supplement|Energy-containing soft drink|Commercial energy/sports drink
12029996|NCT00367536|Drug|bazedoxifene/conjugated estrogens combination tablet|
12029997|NCT00367497|Drug|Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin|
12029998|NCT00367484|Biological|Rebif® (clone 484-39)|s.c. administered Rebif®
12029999|NCT00367471|Drug|lapatinib|Lapatinib (GW572016) is a potent small molecule, reversible inhibitor of both EGFR and ErbB2 tyrosine kinases
12030000|NCT00367471|Drug|carboplatin|An alkylating agent used in the treatment of some cancers
12030001|NCT00367471|Drug|trastuzumab|A monoclonal antibody that interferes with the HER2/neu receptor
12030002|NCT00367471|Drug|paclitaxel|A mitotic inhibitor used in cancer treatment
12030003|NCT00367458|Drug|Atorvastatin|80 mg atorvastatin oral daily
12030004|NCT00367458|Drug|Placebo|patients will be administered placebo
12030005|NCT00367445|Drug|Inhaled Human Insulin (Exubera)|
12030006|NCT00367445|Drug|Insulin Glargine (Lantus)|
12030123|NCT00366379|Drug|GK Activator (2)|25-200mg po bid for 20 weeks
12030007|NCT00367432|Drug|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
12030008|NCT00367419|Drug|Erythromycin|
12030009|NCT00367406|Device|Gamma 3 nail versus ACE trochanteric nail|Comparing Gamma 3 nail versus ACE trochanteric nail
12030010|NCT00367393|Drug|Pimecrolimus cream 1%|Pimecrolimus cream 1% bid, as needed
12030011|NCT00367380|Other|413ABM|+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM
12030012|NCT00367380|Other|414WRR|+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR
12030013|NCT00367380|Other|418JAL|+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL
12030014|NCT00367367|Procedure|Hysteroscopy and Curettage|
12030015|NCT00367341|Drug|escitalopram|Participants will receive treatment with escitalopram for 12 weeks.
12030016|NCT00367341|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT will include 16 1 hour sessions provided over 12 weeks.
12030017|NCT00367328|Device|1320nm Nd: YAG nonablative laser|a 4 mm piece of skin tissue (about the size of a pencil-head eraser) from the affected area. This procedure is called a punch biopsy and will be done to confirm your diagnosis. A culture swab similar to a Q-Tip will be used to wipe the affected areas during the first visit to determine any bacteria that may be present. A survey with questions will be given at the first visit, again after 3 months and at the last visit to measure the success of the treatment. Photographs will be taken prior to each treatment and one month following your last treatment. A laser, which is a very powerful light, will be used to treat half of the skin that is affected by your condition.
12030018|NCT00367315|Drug|Lumiracoxib|
12030019|NCT00367302|Drug|buprenorphine|maintenance
12030020|NCT00367302|Drug|methadone|maintenance
12030021|NCT00367276|Drug|Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)|Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval.
12030022|NCT00367263|Drug|Alvesco (Ciclesonide) 160 ug/day|
12030023|NCT00367250|Drug|Cetuximab|weekly i.v.
12030024|NCT00367250|Drug|Trastuzumab|weekly i.v.
12030025|NCT00367237|Drug|Infliximab + methotrexate (IFX + MTX)|Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6.
12030026|NCT00367237|Drug|Methotrexate (MTX)|Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.
12030027|NCT00367224|Procedure|6 to 9 ultraviolet B treatments|Treatments with ultraviolet B with gradually progressive doses
12030028|NCT00367224|Procedure|Skin biopsies|4 mm punch biopsies of the skin
12030029|NCT00367211|Drug|PN 200 tablets (500 mg naproxen and 20 mg omeprazole)|
12030030|NCT00367211|Drug|Naproxen 500 mg tablets (PN 200 minus omeprazole)|
12030031|NCT00367198|Dietary Supplement|Pro-Stat|two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session
12030032|NCT00367185|Drug|Thalidomide|
12030033|NCT00367172|Behavioral|Directly Administered Antiretroviral Therapy|
12030034|NCT00367159|Procedure|endoscopic treatment of vesico-renal reflux|Autologous Adipocytes Graft (lipostructure)
12030035|NCT00367146|Drug|MMF|
12030036|NCT00367133|Procedure|Standard of Care Group|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
12030037|NCT00367133|Drug|1mg triamcinolone acetonide|Intravitreal injection of 1mg of triamcinolone acetonide at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
12030038|NCT00367133|Drug|4mg triamcinolone acetonide|4mg intravitreal triamcinolone acetonide injection at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
12030039|NCT00367120|Drug|Azithromycin Extended Release|
12030040|NCT00367120|Drug|Amoxicillin/Clavulanate|
12030041|NCT00367094|Drug|Benazepril plus hydrochlorothiazide|
12030042|NCT00367081|Drug|TMX-SMX (Bactrim(R))|
12030043|NCT00367081|Drug|Pyrimethamine plus Sulfadiazine plus leucoverin|
12030044|NCT00367068|Drug|baclofen, intrathecal|
12030045|NCT00367068|Device|infusion pump for intrathecal baclofen, Synchromed, Medtronic|
12030046|NCT00367055|Drug|rosiglitazone-metformin|
12030047|NCT00367055|Drug|Metformin|
12030048|NCT00367055|Drug|metformin+ gliclazide|
12030049|NCT00367042|Device|Scalpel for tissue scoring|During Mohs surgery we will compare the outcomes of scarring, to determine whether a mark (with a pen) or a score with a scalpel will receive the best scar.
12030050|NCT00367042|Device|Surgical marker for tissue marking|You will be asked to participate, examined, discuss participation have procedure and come in for follow up for photos and check up.
12030051|NCT00367029|Behavioral|Individualized Print-Based Motivational Program|"Study researchers will develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year.
~Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff."
12030052|NCT00367016|Drug|Xolair (Omalizumab)|Xolair (Omalizumab) will be given by subcutaneous injection according to Ige level and weight calculation.
12030053|NCT00367016|Drug|Placebo|Placebo
12030124|NCT00366366|Biological|Infanrix-Hexa|
12030125|NCT00366353|Other|Sedation during SBT|
12030126|NCT00366353|Other|No sedation|
12030054|NCT00367003|Device|Deep Brain Stimulation|The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
12030055|NCT00366990|Behavioral|Low Sodium Diet|Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics with a focus on lowering sodium intake.
12030056|NCT00366990|Behavioral|Regular Sodium Intake|Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics.
12030057|NCT00366977|Behavioral|Multi-session telephone counseling|
12030058|NCT00366977|Drug|NRT patches|
12030059|NCT00366964|Device|Laser Treatment|The laser treatment involves the use of an FDA approved laser device (510K Clearance certificate) for hair removal and treatment of leg veins for females having skin types III - VI. The pulses are of appropriate energy and pulse duration based on the skin type.
12030060|NCT00366964|Device|Wave Light laser device for skin treatment|To determine efficacy of FDA approved Laser treatment for hair removal and leg veins. The Mydon Wavelight is a Long Pulsed Nd Yag Laser, Class IV 1064 nm 55W
12030061|NCT00366951|Procedure|Foley catheter only|
12030062|NCT00366951|Procedure|Extraamniotic saline infusion|
12030063|NCT00366938|Drug|Lumiracoxib|
12030064|NCT00366925|Device|Adacolumn®|
12030065|NCT00366912|Device|non-invasive ventilation|
12030066|NCT00366899|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
12030067|NCT00366899|Biological|7 valent pneumococcal conjugate vaccine|Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
12030068|NCT00366873|Procedure|Calcium absorption|formula with or without prebiotics
12030069|NCT00366860|Behavioral|Soy bread|
12030070|NCT00366834|Drug|Casopitant (GW679769) oral tablets|
12030071|NCT00366834|Drug|Casopitant (GW679769) intravenous|
12030072|NCT00366834|Drug|Dexamethasone intravenous|
12030073|NCT00366834|Drug|Ondansetron oral tablets|
12030074|NCT00366834|Drug|placebo|casopitant placebo
12030075|NCT00366808|Procedure|LASIK surgery|
12030076|NCT00366795|Drug|Satavaptan|oral administration once daily
12030077|NCT00366795|Drug|placebo|oral administration once daily
12030078|NCT00366782|Biological|rB/HPIV3|Live attenuated rB/HPIV3 vaccine given at a dose of 10^6 TCID50
12030079|NCT00366782|Biological|rB/HPIV3|Live attenuated rB/HPIV3 vaccine given at a dose of 10^5 TCID50
12030080|NCT00366782|Biological|Placebo|Placebo for rB/HPIV3 vaccine
12030081|NCT00366769|Device|Wavefront-guided LASIK using CustomVue platform|
12030082|NCT00366743|Procedure|Conventional LASIK|
12030083|NCT00366743|Procedure|Wavefront-guided LASIK|
12030084|NCT00366730|Drug|Nitazoxanide|
12030085|NCT00366704|Drug|bifeprunox|.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
12030086|NCT00366704|Drug|risperidone|4mg, QD, 8 week treatment
12030087|NCT00366691|Drug|Acular LS|
12030088|NCT00366691|Drug|Lotemax|
12030089|NCT00366678|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
12030090|NCT00366678|Biological|7-valent pneumococcal conjugate vaccine|Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
12030091|NCT00366678|Drug|Pentavac|The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
12030092|NCT00366665|Device|Legacy 20000|
12030093|NCT00366665|Device|Infinit system|
12030094|NCT00366652|Drug|desvenlafaxine SR|
12030095|NCT00366652|Drug|desipramine|
12030096|NCT00366652|Drug|duloxetine|
12030097|NCT00366639|Other|Acute Decompensated Heart Failure|Treatment & outcomes during hospital admission for Acute DHF
12030098|NCT00366626|Drug|Naltrexone|Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7)
12030099|NCT00366626|Drug|Placebo|Placebo for 7 days matched to Naltrexone
12030100|NCT00366613|Procedure|Cataract surgery with Perfect Capsule and Sodium Chloride|
12030101|NCT00366600|Drug|neratinib|HKI-272
12030102|NCT00366587|Device|Cataract surgery and IOL implantation|
12030103|NCT00366574|Device|Amadeus Microkeratome|
12030104|NCT00366574|Device|IntraLase|
12030105|NCT00366548|Biological|13 valent pneumococcal conjugate vaccine with Polysorbate 80|
12030106|NCT00366548|Biological|13 valent pneumococcal conjugate vaccine without Polysorbate 80|
12030107|NCT00366535|Drug|Placebo|4 tabs b.i.d.
12030108|NCT00366535|Drug|Neurotropin|4 tabs b.i.d.
12030109|NCT00366522|Drug|LXR-623|
12030110|NCT00366496|Device|Acrysof single piece (SA60AT)|
12030111|NCT00366496|Device|Acrysof IQ (SN60WF)|
12030112|NCT00366483|Drug|Lecozotan SR|
12030113|NCT00366470|Drug|A. 100,000 IU Cholecalciferol per dose of 3.3ml|100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months
12030114|NCT00366470|Other|B. Migliol Oil without Cholecalciferol|3.3 ml Migliol Oil, every two weeks for two months
12030115|NCT00366457|Drug|Bevacizumab|Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
12030116|NCT00366457|Drug|Erlotinib|Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
12030117|NCT00366457|Drug|Gemcitabine|Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
12030118|NCT00366444|Drug|diclofenac potassium (XP21L)|25 mg every 6 hours
12030119|NCT00366444|Drug|Placebo|Placebo every 6 hours
12030120|NCT00366431|Drug|MOA-728|
12030121|NCT00366418|Drug|Rituximab|
12030127|NCT00366340|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
12030128|NCT00366340|Biological|7-valent pneumococcal conjugate vaccine|Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
12030129|NCT00366327|Drug|Bifeprunox|Flex dose (20 or 30 mg)tablet, QD for 1 year
12030130|NCT00366301|Drug|Insulin glargine injection|Once daily for 14 weeks
12030131|NCT00366301|Drug|metformin|Up to 4 pils per day (2g per day) maximum
12030132|NCT00366301|Drug|Placebo pill|Up to 4 pills per day
12030133|NCT00366288|Drug|PAZ-417|2.5 mg, 5, 10, 25, 50 mg - fasted in healthy young 10 mg - food effect in healthy young 5 and 25 mg -fasted healthy elderly.
12030134|NCT00366275|Procedure|Immunochemotherapy, in vivo purging and autrotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 10^9/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day subcutaneously) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
12030135|NCT00366262|Drug|PLA-695|
12030136|NCT00366262|Drug|Naproxen|
12030137|NCT00366262|Drug|Placebo|
12030138|NCT00366249|Drug|Tigecycline|150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
12030139|NCT00366249|Drug|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
12030140|NCT00366236|Drug|Nitazoxanide|
12030141|NCT00366210|Behavioral|Constraint-Induced Movement (CI) Therapy|
12030142|NCT00366210|Behavioral|Stretching, Relaxation, & Biofeedback|Passive stretching of both arms, EMG biofeedback for more-impaired arm
12030143|NCT00366171|Drug|Bifeprunox|
12030144|NCT00366158|Device|Device: St. Jude Medical Victory dual-chamber pacemaker|Pacemaker implant
12030145|NCT00366158|Device|Ventricular Intrinsic Preference|Programming of pacemaker
12030146|NCT00366145|Biological|Mesenchymal Stem Cells|2 Infusions of 2 million cells/kg per week for 4 weeks
12030147|NCT00366145|Biological|placebo|2 Infusions per week for 4 weeks
12030148|NCT00366145|Drug|Standard of Care for GVHD|Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy).
12030149|NCT00366132|Device|Extracorporeal Shockwaves|
12030150|NCT00366119|Drug|Ramipril|
12030151|NCT00366106|Drug|bortezomib|Patients will be treated with bortezomib at 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days (cycle).
12030152|NCT00366106|Drug|dexamethasone|Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).
12030153|NCT00366106|Drug|doxorubicin HCl liposome|Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m^2 on Day 4 every 28 days (cycle).
12030154|NCT00366093|Drug|Eszopiclone|eszopiclone 3 mg
12030155|NCT00366093|Drug|Placebo|placebo tablet
12030156|NCT00366080|Drug|GSK189254|
12030157|NCT00366067|Drug|Phenytoin|
12030158|NCT00366041|Drug|Dermal substrate cellularised LG002 (10x10cm)|application depending on burn injury surface
12030159|NCT00366041|Device|Dermal substrate uncellularised LG002 (10x10 cm)|depending on burn injury surface
12030160|NCT00366028|Behavioral|Organization Model|The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.
12030161|NCT00366028|Behavioral|Data Feedback Model|The research team will periodically interview the facilities and provide them with reported hand hygiene data.
12030162|NCT00366015|Procedure|Robotic-assisted Coronary Surgical Revascularization|Robotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console
12030163|NCT00366015|Procedure|PCI- Drug Eluting Stents|Drug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery
12030164|NCT00366002|Drug|Darifenacin|Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
12030165|NCT00365989|Device|ExAblate Enhanced Sonication|
12030166|NCT00365976|Drug|Eszopiclone|Eszopiclone 3 mg po nightly for duration of study blind phase.
12030167|NCT00365976|Drug|Placebo|Placebo nightly over duration of double blind study phase
12030168|NCT00365963|Device|Comprehensive Health Enhancement Support System|computer based support and education
12030169|NCT00365950|Drug|Duration of anticoagulation|
12030170|NCT00365950|Drug|Warfarin duration|
12030171|NCT00365937|Biological|Immunological peptides and immunological adjuvants|
12030172|NCT00365937|Biological|HLA-A2 peptides|Tyrosinase.A2: lyophilized powder, 326 mcg, 5 injections every 3 weeks MAGE-C2.A2: lyophilized powder, 320 mcg, 5 injections every 3 weeks NY-ESO-1b.A2: lyophilized powder, 290 mcg, 5 injections every 3 weeks MAGE-4.A2: lyophilized powder, 299 mcg, 5 injections every 3 weeks MAGE-3.A2: lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-1.A2: lyophilized powder, 298 mcg, 5 injections every 3 weeks NA17.A2 (GnTV): lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-10.A2: lyophilized powder, 309 mcg, 5 injections every 3 weeks
12030173|NCT00365937|Biological|Montanide ISA51|Oil emulsion (W/O: droplet test S57 IN 001), conductivity less than 10mcs.cm-1, viscosity: 1500 mPas (brookfield DVI - spindle 2- Speed 30). For human applications. Injected 5 times every 3 weeks.
12030174|NCT00365937|Biological|IMP321|"Official name of the LAG-3 molecule is CD223. Chemical structure: hLAG-3Ig is a soluble human recombinant LAG-3 protein comprising the extra-cellular Ig-like domains.
~The IMP321 drug product is composed of a soluble recombinant protein at a 1.18 mg/ml concentration, in PBS (Na2HPO4 2H2O 8.1mM, KH2PO4 1.47mM, NaCl 137mM, KCl 2.68mM, PH 7.2). Batch number: S017/LC1/041011.IMP321 will be provided in 250mcl aliquots in brosilicate siliconized vials."
12030175|NCT00365924|Drug|Forteo|Open label single arm study with Forteo as an intervention
12030176|NCT00365911|Procedure|Taking blood sample|A blood sample will be taken.
12030177|NCT00365898|Drug|Hydromorphone Hydrochloride Extended-Release|
12030178|NCT00365885|Other|Computer-based clinical decision support.|computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
12030179|NCT00365872|Biological|Dendritic Cell (DC) Injections|"DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation.
~One additional DC injection was given before surgery to assess DC migration
~Patients were assigned to one of three cohorts:
~Group 1 - DC injection # 4 given 24 hours prior to surgery Group 2 - DC injection # 4 given 48 hours prior to surgery Group 3 - DC injection # 4 given 72 hours prior to surgery"
12030180|NCT00365872|Procedure|Radiation therapy|Radiation was delivered 5 days per week (Monday-Friday).
12030181|NCT00365872|Procedure|Complete Resection - Surgery for tumor removal|Tumors were surgically resected 3-6 weeks after the completion of EBRT.
12030182|NCT00365859|Drug|Aripiprazole|Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
12030183|NCT00365846|Drug|Campath-1H|
12030184|NCT00365820|Drug|Tegaserod|
12030185|NCT00365807|Behavioral|Positively Fit|12-week group intervention for children with obesity and their parents/caregivers
12030186|NCT00365807|Other|Brief Family Intervention (Primarily education)|3 hours of contact with registered dietician for education and nutritional counseling.
12030187|NCT00365794|Drug|Topical testosterone gel 10 g/day|Testosterone gel therapy for 20 weeks
12030188|NCT00365781|Drug|ISIS 113715|
12030189|NCT00365768|Drug|Glutamine|Administered orally twice daily for 21 days
12030190|NCT00365768|Other|Placebo|Administered orally twice daily for 21 days
12030191|NCT00365755|Drug|carboplatin|
12030192|NCT00365755|Drug|cisplatin|
12030193|NCT00365755|Drug|cyclophosphamide|
12030194|NCT00365755|Drug|etoposide|
12030195|NCT00365755|Drug|melphalan|
12030196|NCT00365755|Drug|vincristine sulfate|
12030197|NCT00365755|Procedure|autologous bone marrow transplantation|
12030198|NCT00365755|Procedure|conventional surgery|
12030199|NCT00365742|Drug|simvastatin|
12030200|NCT00365742|Drug|red yeast rice|
12030201|NCT00365742|Drug|pharmaceutical grade fish oil|
12030202|NCT00365742|Behavioral|therapeutic lifestyle changes|
12030203|NCT00365729|Behavioral|Smear and biopsy testing for HPV-types and viral load|Smear and biopsy testing for HPV-types and viral load
12030204|NCT00365716|Biological|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
12030205|NCT00365716|Biological|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
12030206|NCT00365716|Biological|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
12030207|NCT00365716|Biological|Placebo (mcg) (Aluminum Adjuvant)225|placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
12030208|NCT00365716|Biological|Placebo (mcg) (Aluminum Adjuvant) 450|placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
12030209|NCT00365703|Procedure|Feeding tube insertion|"Orogastric feeding tube
~Nasogastric feeding tube"
12030210|NCT00365690|Behavioral|Telephone-administered coping improvement therapy|Telephone-administered coping improvement therapy is aimed to improve coping in older adults living with HIV/AIDS. Participants will partake in 12 weekly conference calls lasting approximately 90 minutes each. Six to eight participants and two group facilitators will be connected via telephone each week. Separate conference call groups will be conducted for men who have sex with men, heterosexual men, and women. Cognitive behavioral principles will be used to evaluate stressor severity, develop problem- and emotion-focused coping skills, determine the relationship between coping strategies and stressor controllability, and optimize coping through use of social support resources. Between weekly sessions, participants will also work to improve coping abilities on their own.
12030211|NCT00365690|Behavioral|Telephone-administered supportive-expressive therapy|Telephone-administered supportive-expressive therapy is aimed to improve relationships with friends, family members, and health care providers. Participants in will partake in 12 weekly conference calls lasting approximately 90 minutes each. Six to eight participants and two group facilitators will be connected via telephone each week. Separate conference call groups will be conducted for men who have sex with men, heterosexual men, and women. The first 60 minutes of each session will focus on discussing topics believed to be of interest to older adults with HIV and providing up-to-date information related to living with HIV/AIDS. The last 30 minutes of each session will be devoted to discussing topics raised by the group.
12030212|NCT00365690|Behavioral|Individual therapy|Participants will receive no active treatment, but will have access to community-based support services that are commonly available to people living with HIV/AIDS. Additionally, participants who experience pronounced periods of emotional crisis and request assistance will be provided with brief, individual, telephone-based therapy by study clinicians.
12030213|NCT00365677|Device|The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm|Used with LASIK treatment for the correction of myopia and myopic astigmatism.
12030214|NCT00365677|Device|The Bausch & Lomb Zyoptix Tissue Saving algorithm|Used with LASIK treatment for the correction of myopia and myopic astigmatism.
12030215|NCT00365651|Procedure|Youth Soccer|
12030216|NCT00365638|Drug|simvastatin|
12030217|NCT00365612|Drug|Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)|
12030218|NCT00365599|Drug|suberoylanilide hydroxamic acid (SAHA, Vorinostat)|Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).
12030219|NCT00365599|Drug|tamoxifen citrate (Tamoxifen)|Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).
12030220|NCT00365586|Drug|Ketoprofen Topical Patch , 20%|
12030221|NCT00365560|Drug|tiotropium|
12030222|NCT00365560|Drug|placebo|
12030223|NCT00365547|Biological|bevacizumab|Will be given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration until disease progression or for another reason.
12030224|NCT00365547|Drug|topotecan hydrochloride|Topotecan 4 mg/m^2 intravenously (IV) will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22. Treatment will be repeated every 28 days until disease progression or for another reason.
12030225|NCT00365534|Procedure|MEI|
12030226|NCT00365521|Procedure|Photodynamic Therapy|
12030227|NCT00365508|Drug|nicotine lozenge|nicotine lozenge
12030228|NCT00365508|Drug|nicotine patch|transdermal nicotine patch
12030229|NCT00365495|Procedure|Physical training (aerobic training)|
12030230|NCT00365469|Dietary Supplement|Probiotic|Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
12030231|NCT00365469|Other|Placebo|Commercially available cow's milk based infant formula without probiotic supplementation
12030232|NCT00365456|Drug|Parathyroid Hormone (PTH)|Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.
12030233|NCT00365456|Drug|Risedronate|Orally once weekly as one 35 mg tablet.
12030234|NCT00365443|Biological|V502|
12030235|NCT00365430|Behavioral|safety program|Education, patient involvement, tailored implementation and a computerized registration system
12030236|NCT00365417|Drug|Bevacizumab|15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles
12030237|NCT00365417|Drug|Doxorubicin|60 mg/m^2 IV every 21 days x 4 cycles
12030238|NCT00365417|Drug|Cyclophosphamide|600 mg/m^2 IV every 21 days x 4 cycles
12030239|NCT00365417|Drug|Capecitabine|Following clinical response assessment, 650 mg/m^2 twice a day (orally), days 1-14 every 21 days x 4 cycles
12030240|NCT00365417|Drug|Docetaxel|Following clinical response assessment, 75 mg/m^2 IV every 21 days x 4 cycles
12030241|NCT00365404|Behavioral|Diet and exercise promotion|
12030242|NCT00365391|Biological|bevacizumab|Given IV, 10 mg/kg, days 1 and 15 in every cycle
12030243|NCT00365391|Drug|erlotinib hydrochloride|Given orally, 150 mg, every day during each cycle.
12030244|NCT00365378|Biological|Comparator: HPV 16 L1 Vaccine|A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6
12030245|NCT00365378|Biological|Comparator: Placebo|A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6
12030246|NCT00365365|Drug|Doxorubicin and cyclophosphamide (AC) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~doxorubicin 60 mg/m^2 IV push or infusion followed by cyclophosphamide 600 mg/m^2 IV push or infusion
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
12030247|NCT00365365|Drug|Docetaxel (T) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~docetaxel 100 mg/m^2 IV
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
~Note: The starting dose of docetaxel was reduced to 75 mg/m^2 if toxicity occurred that met the criteria for doxorubicin dose reduction"
12030248|NCT00365365|Drug|Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~doxorubicin 50 mg/m^2 IV push or infusion followed by cyclophosphamide 500 mg/m^2 IV push or infusion followed by docetaxel 75 mg/m^2
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
12030249|NCT00365365|Drug|Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~docetaxel in 75 mg/m^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by
~trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2)
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
12030250|NCT00365365|Drug|Bevacizumab and trastuzumab maintenance therapy|"bevacizumab 15 mg/kg was infused IV followed by
~trastuzumab 6 mg/kg IV
~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."
12030251|NCT00365365|Drug|Bevacizumab maintenance therapy|"- bevacizumab 15 mg/kg was infused IV
~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."
12030252|NCT00365352|Drug|XP13512 600MG|XP13512 600MG ONCE DAILY
12030253|NCT00365352|Drug|XP13512 1200MG|XP13512 1200MG ONCE DAILY
12030254|NCT00365352|Drug|PLACEBO|PLACEBO ONCE DAILY
12030255|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir|Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
12030256|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
12030257|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
12030258|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
12030259|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
12030260|NCT00365326|Procedure|catheter-based intracoronary injection|
12030261|NCT00365313|Drug|celecoxib, esomeprazole|
12030262|NCT00365300|Drug|pantoprazole|
12030263|NCT00365300|Drug|Placebo|
12030264|NCT00365287|Drug|anti-thymocyte globulin|
12030265|NCT00365287|Drug|cyclophosphamide|
12030266|NCT00365287|Drug|cyclosporine|
12030267|NCT00365287|Drug|fludarabine phosphate|
12030268|NCT00365287|Drug|mycophenolate mofetil|
12030269|NCT00365287|Procedure|radiation therapy|
12030270|NCT00365287|Procedure|umbilical cord blood transplantation|
12030271|NCT00365274|Drug|Cyclophosphamide|Given IV 750 mg/m^2 day 1
12030272|NCT00365274|Drug|Doxorubicin hydrochloride|Given 50 mg/m^2 IV day 1
12030273|NCT00365274|Drug|vincristine sulfate|Given 1.4 mg/m^2 IV
12030274|NCT00365274|Drug|prednisone|100 mg orally daily days 1 - 5
12030275|NCT00365274|Drug|SGN-30|12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
12030276|NCT00365261|Drug|Eszopiclone|eszopiclone 2 to 3 mg po at bedtime
12030277|NCT00365261|Drug|Placebo|placebo 2 to 3 mg po at bedtime
12030278|NCT00365248|Drug|Fibrinogen human (TachoSil)|Resection of the liver with or without segmental liver transplantation
12030279|NCT00365222|Drug|Temozolomide|temozolomide 75 mg/m2 /d
12030280|NCT00365209|Other|laboratory biomarker analysis|Correlative studies
12030281|NCT00365209|Other|pharmacological study|Correlative studies
12030282|NCT00365209|Drug|curcumin|Given orally
12030283|NCT00365196|Behavioral|CBT Hostility Reduction Program|
12030284|NCT00365183|Drug|Motexafin gadolinium and pemetrexed|1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
12030285|NCT00365170|Drug|human insulin|
12030286|NCT00365170|Drug|insulin aspart|
12030287|NCT00365157|Drug|Eribulin Mesylate|Given IV
12030288|NCT00365157|Other|Laboratory Biomarker Analysis|Correlative studies
12030289|NCT00365157|Other|Pharmacological Study|Correlative studies
12030290|NCT00365144|Biological|bevacizumab|
12030291|NCT00365144|Drug|erlotinib hydrochloride|
12030292|NCT00365144|Other|laboratory biomarker analysis|
12030293|NCT00365131|Drug|Cerezyme (imiglucerase for injection)|
12030294|NCT00365118|Device|Pulsed dye laser (Candela), Intense pulsed light (Palomar)|
12030295|NCT00365105|Dietary Supplement|Calcium|At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
12030296|NCT00365105|Dietary Supplement|Vitamin D|400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
12030297|NCT00365105|Drug|zoledronic acid|4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
12030298|NCT00365105|Drug|Sm-153|Single dose intravenously 1 mCi/kg body weight.
12030299|NCT00365105|Radiation|Sr-89|Single dose intravenously 4 mCi.
12030300|NCT00365092|Procedure|Insertion of tympanostomy tubes|
12030301|NCT00365053|Drug|belinostat|Given IV
12030302|NCT00365053|Other|laboratory biomarker analysis|Correlative studies
12030303|NCT00365040|Procedure|Prk with mitomycin vs Lasik|
12030304|NCT00365027|Procedure|Delayed embryo transfer|
12030305|NCT00365001|Drug|tocilizumab [RoActemra/Actemra]|10mg/kg iv on day 8
12030306|NCT00365001|Drug|Methotrexate|10-25mg po/week
12030307|NCT00365001|Drug|Simvastatin|40mg po on days 1, 15 and 43
12030308|NCT00364988|Drug|pioglitazone+losartan|Pioglitazone (30 mg/daily) losartan (100 mg daily)
12030309|NCT00364988|Drug|losartan|losartan (100 mg daily)
12030310|NCT00364975|Behavioral|gourmet cooking workshop|
12030311|NCT00364936|Procedure|Palliative care service|
12030312|NCT00364923|Drug|Pralatrexate Injection|Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.
12030313|NCT00364910|Behavioral|Cognitive behavioral therapy (CBT)|Participants meet with a therapist for three to five sessions brief exposure-based CBT.
12030314|NCT00364910|Behavioral|Educational session and treatment as usual|Participants assigned to the educational session attend one meeting with a researcher to discuss the results from their evaluation. They could also be referred to a mental health clinic of their choice to help relieve their symptoms.
12030315|NCT00364884|Drug|ketoaminoacid|
12030316|NCT00364871|Drug|naltrexone and bupropion SR|naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
12030317|NCT00364858|Drug|Cerezyme|Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).
12030318|NCT00364845|Drug|Darbepoetin alfa|Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.
12030319|NCT00364845|Drug|Placebo|Prefilled syringe placebo, to match active arm
12030320|NCT00364832|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Differing doses and frequencies of sc administration
12030321|NCT00364819|Drug|rituximab|rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours
12030322|NCT00364806|Drug|Prochlorperazine|
12030323|NCT00364806|Drug|Metoclopramide|
12030324|NCT00364793|Drug|Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)|"Oral Solution, Capsules or Tablets, Oral, once daily
~Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg)
~Didanosine (ddI) 240 mg/m2 (max 400 mg)
~Emtricitabine (FTC) 6 mg/kg (max 200 mg)
~Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer);
~Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first)"
12030325|NCT00364780|Drug|XL647|XL647 will be administered orally as a single agent. XL647 will be supplied as 50 mg tablets. Subjects in the Intermittent 5 & 9 cohort will receive XL647 at a dose of 350 mg on a 5 days on and 9 days off cycle every 2 weeks for 8 weeks. Subjects in the Daily Dosing cohort will receive XL647 administered daily as a single oral dose of 300 mg. In the absence of progressive disease (PD) and unacceptable XL647-related toxicity, subjects may continue to receive XL647 treatment on their assigned dosing schedule for up to 1 year on this study. Subjects who reach 1 year of treatment with no evidence of disease progression may, with the concurrence of the investigator and the sponsor, continue to receive therapy.
12030326|NCT00364767|Dietary Supplement|A|Alcohol consumption (32 g/day) for 4 weeks
12030327|NCT00364767|Dietary Supplement|B|Water
12030328|NCT00364754|Drug|Tesmilifene (YMB 1002)|
12030329|NCT00364741|Drug|Oxygen|During and 2 hours after surgery
12030330|NCT00364702|Drug|methylphenidate|
12030331|NCT00364689|Drug|Rifaximin|
12030332|NCT00364689|Drug|Lactulose|
12030333|NCT00364689|Other|Placebo|
12030334|NCT00364676|Drug|VLI|Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
12030335|NCT00364676|Drug|VLI|Patients are dosed on Day 1 of a 21-day cycle.
12030336|NCT00364650|Drug|Probiotic Supplement|2 capsules twice daily
12030337|NCT00364650|Other|Placebo|placebo
12030338|NCT00364637|Drug|Sevoflurane (Volatile Anesthetic)|
12030339|NCT00364637|Drug|Total intravenous anesthesia|
12030340|NCT00364611|Drug|Bevacizumab|"Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on
~On Day 1 of the 1st cycle over 120 minutes
~On Day 1 of the 2nd cycle over 90 minutes, if no reaction on the first dose
~On Day 1 of 3rd cycle over 60 minutes, if no reaction on previous doses
~On Day 1 of subsequent cycles over 30 minutes, if no reaction on previous doses"
12030341|NCT00364611|Drug|Docetaxel|Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w
12030342|NCT00364611|Drug|Trastuzumab|"A loading dose of 8 mg/kg Trastuzumab (Herceptin) IV will be infused over 90 minutes on Day 2 of Cycle 1.
~For all subsequent cycles 6 mg/kg trastuzumab will be administered on Day 1 one hour following completion of docetaxel infusion"
12030343|NCT00364598|Drug|Anginera, a human tissue replacement therapy|
12030344|NCT00364585|Device|GreenLight Model 120 Laser System|
12030345|NCT00364572|Drug|epidural injection of etanercept|2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg
12030346|NCT00364572|Drug|placebo (control procedure)|Two injections of epidural saline 2 weeks apart
12030347|NCT00364559|Drug|Rosuvastatin|20 mg 10 days daily
12030348|NCT00364546|Drug|CG 5503;tapentadol|
12030349|NCT00364533|Drug|Tapentadol IR (CG5503)|Fixed Dose 50, 75, & 100 mg BID for 3 days
12030350|NCT00364533|Drug|Placebo|Fixed Dose Matching placebo for 3 days
12030351|NCT00364533|Drug|Oxycodone HCL IR|Fixed Dose 10 mg BID for 3 days
12030352|NCT00364533|Drug|Tapentadol IR (CG5503)|Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days
12030353|NCT00364520|Other|Shanghai workers|
12030354|NCT00364494|Procedure|Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)|Subgroup 1,with Ht<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht>25% bleed or not
12030355|NCT00364481|Drug|omeprazole|
12030356|NCT00364481|Behavioral|Tongue exercises|
12030357|NCT00364468|Drug|pegfilgrastim|
12030358|NCT00364455|Drug|Epoetin alfa|
12030359|NCT00364442|Drug|fluticasone propionate/salmeterol|investigational drug
12030360|NCT00364429|Drug|[123]I-CNS 1261|Study Drug
12030361|NCT00364429|Drug|Lorazepam|Study Drug
12030362|NCT00364429|Drug|Risperidone|Study Drug
12030363|NCT00364416|Other|Any treatment used to treat CHF|Clinical Outcomes of Chronic Decompensated Heart Failure patients
12030364|NCT00364403|Behavioral|Low glycemic load|Provision of foods and dietary counseling to promote a low glycemic load diet
12030365|NCT00364403|Behavioral|Low fat diet|Provision of foods and dietary counseling to promote a low fat diet
12030366|NCT00364390|Drug|Anginera, a human tissue replacement therapy|
12030367|NCT00364377|Drug|Sitagliptin|100 mg once daily
12030368|NCT00364377|Other|Placebo|once daily for duration of the study
12030369|NCT00364364|Drug|Radiolabeled humanized PAM4 IgG|
12030370|NCT00364351|Drug|Vandetanib|once daily oral tablet
12030371|NCT00364351|Drug|Erlotinib|oral dose
12030372|NCT00364338|Behavioral|gourment cooking workshop|
12030373|NCT00364325|Other|Acute Decompensated Heart Failure|Standard of Care
12030374|NCT00364312|Behavioral|diet and physical activity|
12030375|NCT00364299|Device|Automatic control of tracheal tube cuff pressure|
12030376|NCT00364286|Drug|Dasatinib (BMS-354825)|50mg Orally twice daily
12030377|NCT00364273|Drug|GSK159802|GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
12030378|NCT00364273|Drug|Placebo|Subjects will receive placebo administered using DISKUS inhaler.
12030379|NCT00364273|Drug|Salmeterol|Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
12030380|NCT00364260|Drug|epoetin alfa|
12030381|NCT00364247|Drug|CG5503 IR;tapentadol|
12030382|NCT00364234|Device|Low magnitude mechanical stimuli|20 minutes standing on low magnitude high frequency vibrating platform
12030383|NCT00364221|Drug|Rosiglitazone|
12030384|NCT00364195|Drug|Tesmilifene (YMB1002)|
12030385|NCT00364182|Drug|Recombinant Coagulation Factor IX (BeneFIX)|100 IU/kg once weekly then crossover to 50 IU/kg twice weekly
12030386|NCT00364182|Drug|Recombinant Coagulation Factor IX (BeneFIX)|50 IU/kg twice weekly then crossover to 100 IU/kg once weekly
12030387|NCT00364169|Procedure|Degree of constipation|
12030388|NCT00364156|Drug|Standard Patch Treatment|8-weeks of nicotine patch + 16-weeks of placebo
12030389|NCT00364156|Drug|24-weeks of nicotine patch|24-weeks of 21mg nicotine patch
12030390|NCT00364143|Drug|IHL-305 (irinotecan liposome injection)|
12030391|NCT00364130|Device|Low magnitude mechanical stimulus|10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
12030392|NCT00364130|Device|Placebo (inactive) low magnitude mechanical stimulus|10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
12030393|NCT00364117|Behavioral|Timely Discharge (Remote Presence Technology)|
12030394|NCT00364104|Drug|Quadruple sequential Helicobacter pylori eradication + iron sulfate|A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation
12030395|NCT00364104|Drug|Quadruple sequential Helicobacter pylori eradication therapy|A 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo of iron supplementation
12030396|NCT00364104|Drug|Ferrous sulfate|6-weeks of iron supplementation only plus 10-days matching placebo of Hp infection eradication therapy
12030397|NCT00364104|Drug|Placebo|Placebo only (10-days of matching placebo of Hp eradication therapy and 6-weeks of matching iron supplementation).
12030398|NCT00364091|Drug|R89674 0.025% ophthalmic solution|
12030399|NCT00364065|Device|Ferris PainWrap|
12030400|NCT00364052|Drug|oral Valganciclovir vs oral Ganciclovir|
12030401|NCT00364039|Drug|AV650|
12030402|NCT00364026|Drug|darusentan|
12030403|NCT00364013|Drug|Panitumumab|Panitumumab 6 mg/kg over on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
12030404|NCT00364013|Drug|FOLFOX regimen|The FOLFOX regimen consisted of oxaliplatin 85 mg/m^2 intravenous (IV) infusion on Day 1, leucovorin, 200 mg/m^2 (racemate) on Days 1 and 2 and 5-fluorouracil 400 mg/m^2 IV bolus followed by 600 mg/m^2 IV infusion over 22 hours on Days 1 and 2. Each cycle was 14 days.
12030405|NCT00364000|Drug|Calcium acetate|Calcium acetate in 240 chronic HD patients
12030406|NCT00364000|Drug|Sevelamer|label sevelamer (RenagelR) 800 mg tablets
12030407|NCT00363987|Drug|Ketosteril®|1 tablet Ketosteril/5kgBW/d
12030408|NCT00363987|Other|diabetic diet|Energy 30-35 Kcal/kg BW/d + protein 0.8 g/kg BW/d
12030409|NCT00363974|Drug|XIAP antisense|2 days loading dose followed by weekly 2hr infusion
12030410|NCT00363961|Behavioral|Resistance exercise|resistance exercise vs sham comparison
12030411|NCT00363948|Drug|Placebo|Double-blind period (12 wk); Placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
12030412|NCT00363948|Drug|Sitagliptin phosphate|Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
12030413|NCT00363935|Drug|Dexmedetomidine|
12030414|NCT00363922|Behavioral|Rehabilitation in institution|Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.
12030415|NCT00363922|Behavioral|Rehabilitation at home|Subjects get a written prescription of exercise training, diet, etc. to follow at home.
12030416|NCT00363922|Behavioral|Out-patient rehabilitation at the hospital|This intervention was removed. We never got time to randomize subjects into this category. We had planned to randomize patients from one hospital to either Rehabilitation in institution (rehab center) or rehabilitation at the hospital (out patient). And also patients from another hospital to either rehabilitation in institution (rehab centre) or rehabilitation at home. We have only managed to start the study in this second hospital so far (due to maternity leave and limited time to finish a PhD)
12030417|NCT00363909|Drug|citalopram hydrobromide|
12030418|NCT00363909|Other|placebo|
12030419|NCT00363896|Drug|Aclidinium bromide|Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
12030420|NCT00363896|Drug|Placebo|Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
12030421|NCT00363883|Drug|vorinostat|Given orally
12030422|NCT00363883|Other|laboratory biomarker analysis|Correlative studies
12030423|NCT00363870|Biological|Fluarix vaccine|
12030424|NCT00363857|Drug|Ropinirole|
12030425|NCT00363844|Drug|Sitagliptin phosphate|50 mg QD or 100 mg QD for 12 months
12030426|NCT00363831|Drug|Oxaliplatin|130mg/m² infusion day 1, repeat every 21 days
12030427|NCT00363805|Dietary Supplement|green tea|Given orally
12030428|NCT00363805|Drug|Polyphenon E|Given orally
12030429|NCT00363805|Other|placebo|Given orally
12030430|NCT00363792|Drug|Glyceryl trinitrate, azetazolamide|
12030431|NCT00363779|Drug|Cyclosporine|An oral preparation given every 12 hours, 5-10 mg/kg/day in divided doses. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml. Levels will be checked twice weekly and once the patient has achieved steady state levels they shall be monitored once every 2 weeks. These therapeutic levels shall be maintained for 3 months.
12030432|NCT00363779|Genetic|Gene expression analysis|A permutation test will be performed to examine whether the overall expression profile changes due to treatment. This will be done by comparing the number of significant genes to the distribution of this number if in fact there is no difference between pre-treatment and post-treatment gene expression.
12030433|NCT00363779|Genetic|Microarray analysis|Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and posttreatment samples.
12030434|NCT00363779|Other|Laboratory biomarker analysis|Analysis of differential gene expression profiles in patients with LGL leukemia treated with cyclosporine.
12030435|NCT00363766|Drug|LY573636-sodium|A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression.
12030436|NCT00363753|Drug|aspirin versus clopidogrel|
12030437|NCT00363740|Drug|GW685698X Aqueous Nasal Spray|
12030438|NCT00363727|Drug|ropinirole controlled-release (REQUIP CR) for RLS|
12030439|NCT00363714|Drug|AGN211745|100microgram single intravitreal injection
12030440|NCT00363714|Drug|AGN211745|200microgram single intravitreal injection
12030441|NCT00363714|Drug|AGN211745|400microgram single intravitreal injection
12030442|NCT00363714|Drug|AGN211745|800microgram single intravitreal injection
12030443|NCT00363714|Drug|AGN211745|1200microgram single intravitreal injection
12030444|NCT00363714|Drug|AGN211745|1600microgram single intravitreal injection
12030445|NCT00363701|Drug|esomeprazole|
12030446|NCT00363688|Drug|Penicillin test and challenge|
12030447|NCT00363675|Behavioral|Functional hand tests|Chilren were tested after healed hand burns for functional ability.
12030448|NCT00363649|Biological|GM-K562 cell vaccine|Given by injection
12030449|NCT00363649|Biological|Interferon alfa|Given by injection
12030450|NCT00363649|Biological|Sargramostim|Given by injection
12030451|NCT00363636|Drug|Galiximab in combination with rituximab|Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
12030452|NCT00363636|Drug|Rituximab in combination with placebo|Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
12030453|NCT00363623|Device|Silicone hydrogel contact lens|
12030454|NCT00363610|Drug|Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma|
12030455|NCT00363584|Drug|capecitabine|
12030456|NCT00363584|Other|clinical observation|
12030457|NCT00363584|Procedure|adjuvant therapy|
12030458|NCT00363571|Drug|GTN, Diamox|
12030459|NCT00363545|Biological|Lyophilized formulation of HRV vaccine|Lyophilized formulation of HRV vaccine
12030460|NCT00363545|Biological|Liquid formulation of HRV vaccine|Liquid formulation of HRV vaccine
12030461|NCT00363532|Drug|infusion of calcitonin gene related peptide (CGRP)|
12030514|NCT00363129|Other|placebo|Given orally
12030462|NCT00363519|Drug|Placebo|Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
12030463|NCT00363519|Drug|Sitagliptin phosphate|Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
12030464|NCT00363506|Behavioral|Serotona Plus and dietary behavior management|
12030465|NCT00363480|Drug|Salmeterol/Fluticasone 50/250 mcg|Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.
12030466|NCT00363480|Drug|Salbutamol 100 mcg|This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.
12030467|NCT00363480|Device|DISKUS™ powder inhalers|Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.
12030468|NCT00363467|Drug|G-CSF|"Mobilization Option 1:Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously.
~Mobilization Option 2: If patients have recovered hematologically from consolidation chemotherapy, they may receive G-CSF at 10 mcg/kg twice daily subcutaneously."
12030469|NCT00363467|Drug|Leukapheresis|leukapheresis
12030470|NCT00363467|Drug|Busulfan|Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2
12030471|NCT00363467|Procedure|Stem cell reinfusion|autologous stem cell transplant
12030472|NCT00363454|Drug|Triciribine Phosphate Monohydrate|8 Cycles @ 28 days. Level 1: 15 mg/m^2; Level 2: 25 mg/m^2; 35 mg/m^2; 45 mg/m^2.
12030473|NCT00363441|Procedure|Intensity Modulated Radiotherapy|
12030474|NCT00363428|Behavioral|exercise intervention|life style
12030475|NCT00363428|Behavioral|smoking cessation intervention|Life style
12030476|NCT00363428|Other|counseling intervention|life style
12030477|NCT00363428|Other|educational intervention|life style
12030478|NCT00363428|Procedure|conventional surgery|life style
12030479|NCT00363428|Procedure|pulmonary complications management/prevention|life style
12030480|NCT00363415|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles
12030481|NCT00363415|Drug|etoposide|100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
12030482|NCT00363415|Drug|carboplatin|Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
12030483|NCT00363402|Procedure|PET-CT|
12030484|NCT00363389|Drug|misoprostol and cervical ripening|
12030485|NCT00363376|Drug|zonisamide|Zonisamide will be administered at an initial dose of 100 mg/d for 7 days. Subsequently, zonisamide may be increased, based on clinical response and tolerability, by 100mg/d every 7 days to a maximum of 600 mg/d by the end of the sixth week of treatment. The maximum amount of zonisamide allowed during the study will be 600 mg/day. The minimum amount of zonisamide allowed during the study will be 100 mg/d. Zonisamide will initially be given as a single pm dose, but alterations in dosing will be permitted to reduce side effects (e.g., as BID dosing to reduce nausea).
12030486|NCT00363376|Drug|olanzapine|olanzapine will be administered open-label at 5-20 mg/d titrated to optimize response and minimize side effects
12030487|NCT00363376|Drug|Zonisamide|zonisamide ranging from 100mg to 600mg daily
12030488|NCT00363376|Drug|Sugar Pill (placebo)|sugar pill (placebo) for zonisamide
12030489|NCT00363363|Behavioral|Physical Activity|Children in this arm of the study will be provided with specific activities to be completed on most days of the week. The selected activities will be based on the child's interests and results of the baseline measures of health-related PA, MVPA and gross motor skill. The resources and facilities available to the family and season of the year will also influence the choice of activities. The frequency and duration of the required activities will be gradually increased until the child's baseline MVPA has been increased by a minimum of 30 minutes per day, most days of the week. Once that increase is achieved, the activities will be modified to maintain and reinforce the higher PA level.
12030490|NCT00363363|Behavioral|Education|Children in this arm of the study will be provided with puzzles, stories and games to be completed each week. The selected activities will be based on the child's interests and designed to increase the child's knowledge of activity options, perceptions of activity benefits, self-confidence for activity participation and motivation for daily activity. The activities introduced will vary with the resources available to the family and the season of the year, and will include information about healthy eating, injury prevention, and healthy lifestyle options.
12030491|NCT00363350|Drug|rituximab (anti-CD20)|2 infusions of 1000 mg
12030492|NCT00363337|Drug|aripiprazole|open label treatment with aripiprazole
12030493|NCT00363324|Procedure|intracoronary injection of bone marrow cells|
12030494|NCT00363311|Drug|Dutasteride|Dutasteride 0.5mg
12030495|NCT00363311|Drug|Matching placebo|Matching placebo
12030496|NCT00363298|Drug|dextro-amphetamine|dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
12030497|NCT00363298|Drug|Sham Comparison|caffeine dosage form: capsules identical to those in dextro-amphetamine arm, but containing 200 mg caffeine in Bottle A and 100 mg caffeine in Bottle B. Frequency: once daily. Duration: 5 weeks
12030498|NCT00363285|Biological|gonadotrophin releasing hormone|
12030499|NCT00363285|Drug|cyproterone acetate|
12030500|NCT00363285|Procedure|quality-of-life assessment|
12030501|NCT00363272|Drug|ispinesib|Given IV
12030502|NCT00363272|Other|laboratory biomarker analysis|Correlative studies
12030503|NCT00363272|Other|pharmacological study|Correlative studies
12030504|NCT00363259|Drug|Peginterferon alfa-2b|
12030505|NCT00363259|Drug|Ribavirin|
12030506|NCT00363233|Drug|flax lignans|
12030507|NCT00363194|Drug|Pazopanib (GW786034)|Pazopanib (GW786034)
12030508|NCT00363168|Drug|Ranibizumab|0.3 mg/0.05 ml dose
12030509|NCT00363168|Drug|Ranibizumab|0.5 mg/0.05 ml dose
12030510|NCT00363155|Drug|KRN7000|
12030511|NCT00363142|Drug|Half-boosted Fosamprenavir|Once daily, reduced dose ritonavir-boosted fosamprenavir
12030512|NCT00363142|Drug|Full Boosted Fosamprenavir|Full ritonavir-boosted fosamprenavir
12030513|NCT00363129|Dietary Supplement|vitamin E|Given orally
12030515|NCT00363116|Drug|Daclizumab|daclizumab 1 mg/kg/dose every 14 days for 5 doses
12030516|NCT00363090|Biological|alemtuzumab|
12030517|NCT00363090|Drug|cyclophosphamide|
12030518|NCT00363090|Drug|doxorubicin hydrochloride|
12030519|NCT00363090|Drug|prednisone|
12030520|NCT00363090|Drug|vincristine sulfate|
12030521|NCT00363090|Other|flow cytometry|
12030522|NCT00363090|Other|pharmacological study|
12030523|NCT00363077|Biological|GSK1247446A Group|Low dose influenza vaccine adjuvanted with AS03 compared
12030524|NCT00363077|Biological|Fluarix™|GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.
12030525|NCT00363051|Drug|Everolimus 10 mg|Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.
12030526|NCT00363051|Drug|Octreotide Depot|
12030527|NCT00363038|Drug|Petrolatum United States Pharmacopeia (USP)|Topical formation applied to bruise twice daily for 2 weeks.
12030528|NCT00363038|Drug|Vitamin K and retinol ointment|Topical formation applied to bruise twice daily for 2 weeks.
12030529|NCT00363038|Drug|Arnica ointment|Topical formation applied to bruise twice daily for 2 weeks.
12030530|NCT00363038|Drug|Vitamin K ointment|Topical formation applied to bruise twice daily for 2 weeks.
12030531|NCT00363025|Procedure|Two post-remission strategies|
12030532|NCT00363025|Drug|Idarubicin versus daunorubicin|
12030533|NCT00363012|Biological|HER-2/neu intracellular domain protein|300mcg (100mcg/peptide) of the HER2 ICD peptide mixture per skin test. This will be injected intradermally on the back at 6 months post active immunization.
12030534|NCT00363012|Other|flow cytometry|This is a laboratory test used to assess the antigen specific T cell population.
12030535|NCT00363012|Other|immunohistochemistry staining method|This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.
12030536|NCT00363012|Procedure|biopsy|A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.
12030537|NCT00363012|Other|Sterile water placement|100mcg of sterile water will be administered intradermally on the back and serves as a negative control for the laboratory analysis. This will be injected intradermally on the back at 6 months post active immunization.
12030538|NCT00362986|Drug|sunscreen|
12030539|NCT00362986|Other|placebo|
12030540|NCT00362973|Other|laboratory biomarker analysis|
12030541|NCT00362973|Procedure|needle biopsy|
12030542|NCT00362973|Procedure|positron emission tomography|
12030543|NCT00362973|Procedure|radionuclide imaging|
12030544|NCT00362973|Radiation|fludeoxyglucose F 18|
12030545|NCT00362960|Drug|Olmesartan medoxomil|
12030546|NCT00362960|Drug|Losartan|
12030547|NCT00362947|Drug|LMWH parnaparin subcutaneously|
12030548|NCT00362934|Drug|fenofibrate / simvastatin|Combination of fenofibrate and simvastatin 20 mg and 40 mg
12030549|NCT00362934|Drug|Atorvastatin|Atorvastatin 10 mg and 20mg
12030550|NCT00362921|Drug|Gliadel wafers in combination with O6-benzylguanine|
12030551|NCT00362908|Behavioral|Moderate Fat and Moderate Carbohydrate Diet|40% allowable fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months
12030552|NCT00362908|Behavioral|Low Fat and High Carbohydrate Diet|20% fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months
12030553|NCT00362895|Drug|Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension|One drop in the study eye, single dose
12030554|NCT00362895|Drug|Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)|One drop in the study eye, single dose
12030555|NCT00362882|Drug|docetaxel|Given IV
12030556|NCT00362882|Drug|bortezomib|Given IV
12030557|NCT00362882|Other|laboratory biomarker analysis|correlative study
12030558|NCT00362882|Other|immunoenzyme technique|correlative study
12030559|NCT00362882|Other|immunohistochemistry staining method|correlative study
12030560|NCT00362882|Other|pharmacological study|correlative study
12030561|NCT00362869|Drug|Levofloxacin|Administered at a dose of 500 mg once a day for 3 days
12030562|NCT00362869|Drug|Placebo|Sodium bicarbonate solution
12030563|NCT00362869|Biological|Enteroaggregative E. coli (EAEC)|Dosages: 1X10^9, 5X10^9, 1X10^10, and 5X10^10 cfu; given in a sodium bicarbonate solution
12030564|NCT00362856|Drug|larazotide acetate|capsule
12030565|NCT00362856|Drug|Placebo|capsule
12030566|NCT00362830|Drug|vinflunine + ixabepilone|solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration
12030567|NCT00362817|Drug|carboplatin|IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
12030568|NCT00362817|Drug|temozolomide|150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
12030569|NCT00362804|Drug|Tetrabenazine|The initial TBZ dose will be 12.5 mg and the dose will be increased to 25 mg at Week 2. Thereafter, the dose can be decreased to 12.5 mg or increased in 12.5 mg increments at weekly intervals, depending on clinical response and tolerability, to a maximum of 75 mg/day. For 37.5 and 50 mg daily, administration will be BID i.e., 25 mg QAM, 12.5 or 25 mg QHS. For 62.5 or 75 mg daily, a TID dosing will be employed i.e., 25 mg QAM, 12.5 or 25 mg QPM, 25 mg QHS
12030570|NCT00362791|Behavioral|"Enhanced HIV/STD Counseling: 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model"|
12030571|NCT00362791|Behavioral|"Brief Counseling (aka client-centered counseling): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior"|
12030572|NCT00362791|Behavioral|"HIV Prevention Education: 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies"|
12030573|NCT00362778|Drug|Insulin|intravenous continuous insulin infusion for 48 hours
12030574|NCT00362765|Drug|Fenofibrate|160 mg
12030575|NCT00362765|Drug|Metformin|2000 mg
12030576|NCT00362765|Drug|Placebo|Placebo
12030577|NCT00362752|Drug|Norfloxacin|400 mg po bid
12030578|NCT00362752|Drug|Placebo|Placebo 400 mg po bid
12030579|NCT00362726|Drug|Rosiglitazone maleate|Tablets, Oral, RGZ 4 mg, once daily, 1 day.
12030580|NCT00362726|Drug|Atazanavir Sulphate|Capsules, Oral, ATV 400 mg, once daily, 5 days.
12030581|NCT00362726|Drug|Atazanavir Sulphate + Rosiglitazone maleate|Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
12030582|NCT00362726|Drug|Atazanavir Sulphate + Ritonavir|Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
12030583|NCT00362726|Drug|Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate|Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
12030584|NCT00362713|Drug|Ipilimumab|Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24
12030585|NCT00362700|Drug|Clevudine|
12030586|NCT00362687|Drug|Truvada (TDF+FTC) alone|tenofovir DF 300 mg and emtricitabine 200 mg in a fixed dose tablet formulation
12030587|NCT00362687|Drug|FTC alone|emtricitabine 200 mg
12030588|NCT00362687|Procedure|No HAART|No HAART
12030589|NCT00362661|Drug|Cortisol|Cortisol 10 mg/d for 3 months
12030590|NCT00362648|Biological|RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent|2.0 mL oral dose of RotaTeq™. 14 week treatment period
12030591|NCT00362648|Biological|Comparator: Placebo|Arm 2: Placebo. 14 week treatment period
12030592|NCT00362635|Drug|Clevudine|
12030593|NCT00362609|Drug|pantoprazole|
12030594|NCT00362596|Drug|acyclovir|
12030595|NCT00362583|Drug|Fentanyl|
12030596|NCT00362570|Drug|Temozolomide|"p.o.(by mouth), 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off] using a standardized dosing range.
~Administration: Temozolomide will be administered on an empty stomach (i.e., 1 hour before or 2 hours after any oral intake)."
12030597|NCT00362557|Device|MRI|Magnetic resonance imaging
12030598|NCT00362544|Drug|Ambisome|
12030599|NCT00362531|Drug|tacrolimus combined with prednisone|
12030600|NCT00362518|Dietary Supplement|Study Arm A|Control: no vitamins (placebo only). This study will provide baseline metabolic and surrogate marker changes that are caused by the high fat meal. Study arms B, C, and D will be statistically compared to this study.
12030601|NCT00362518|Dietary Supplement|Study Arm B|This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a low dosage form of vitamin C is administered (250 mg) and Vitamin E (200 IU).
12030602|NCT00362518|Dietary Supplement|Study Arm C|This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a medium dosage form of vitamin C administered (500 mg)and Vitamin E (400 IU).
12030603|NCT00362518|Dietary Supplement|Study Arm D|This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a high dosage form of vitamin C is administered (1000 mg) and Vitamin E (800 IU).
12030604|NCT00362505|Drug|Clevudine|
12030605|NCT00362492|Procedure|Bilateral ultrasound examination 7+/- 2 after surgery|
12030606|NCT00362479|Drug|DR-1021|1 tablet daily
12030607|NCT00362466|Drug|Dasatinib|Tablets, Oral, Once daily, 5-7 years
12030608|NCT00362466|Drug|Imatinib|Tablets, Oral, Once daily, 5-7 years
12030609|NCT00362453|Behavioral|Tai Chi versus Attention Control|60 minutes, twice a week for 12 weeks.
12030610|NCT00362440|Drug|Leptin|
12030611|NCT00362440|Drug|Pioglitazone or metformin|
12030612|NCT00362440|Drug|Placebo|
12030613|NCT00362427|Biological|Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC|0.5 mL, 4 doses, IM
12030614|NCT00362427|Biological|Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC|0.5 Ml, 4 doses, IM
12030615|NCT00362427|Biological|Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC|0.5 mL, 4 doses, IM with concommitant vaccines
12030616|NCT00362414|Drug|Dual Growth Factor|"10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
12030617|NCT00362388|Procedure|Intramyocardial injection of autologous bone marrow cells|
12030618|NCT00362375|Behavioral|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
12030619|NCT00362375|Behavioral|HIV/AIDS 101 Workshop|The comparison workshop (named HIV101) was also delivered as a single session lasting 2-3 h, to groups of women about the same size and in settings similar to those used for the HLW. The HIV101 workshop consists of an opening, one module containing the same three HIV/STD-related components as the HLW (HIV/AIDS facts, STI facts, and the Look of HIV) and a closing. However, the presentation of this information used a didactic, lecture-style format, as opposed to the interactive approach used to deliver the HLW.
12030620|NCT00362349|Drug|IgNextGen 10%|"Ig NextGen 10% is a liquid formulation and is to be administered intravenously. At the discretion of the Investigator, patients could be administered Ig NextGen 10% in accordance with either of two dosage regimens:
~Regimen One: 1 g/kg body weight of Ig NextGen 10% administered daily for two days.
~Regimen Two: 0.4 g/kg body weight of Ig NextGen 10% administered daily for five days"
12030621|NCT00362336|Biological|DTaP-IPV-HB-PRP~T|0.5 mL, Intramuscular (IM)
12030622|NCT00362336|Biological|CombAct-HIB®|0.5 mL, IM
12030623|NCT00362336|Biological|Engerix B® Pediatric|0.5 mL, IM
12030624|NCT00362323|Drug|fenofibrate (F) + metformin (M) hydrochloride fixed combination|F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks
12030625|NCT00362323|Drug|Metformin|500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks
12030626|NCT00362310|Drug|indinavir|
12030627|NCT00362297|Drug|acyclovir|800 mg orally three times daily for 7 weeks
12030628|NCT00362297|Drug|valacyclovir|500 mg orally once daily for 7 weeks
12030683|NCT00361842|Drug|CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection|CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.
12030684|NCT00361803|Drug|topotecan|topotecan
12030737|NCT00361374|Dietary Supplement|eicosapentaenoic acid|1 gram/day
12030629|NCT00362284|Behavioral|NYUCI-AC|Approximately six individual and family consultation sessions (2 individual, 3 family, 1 individual) within the first 4 months with adult child caregivers and/or their family members; support group participation (recommended at least once a month) after the completion of the individual and family consultation sessions for the duration of the project (up to 3 years after the intake interview); ad hoc consultation (ongoing in-person, telephone, or email support on an as-needed basis) for the duration of the project (up to 3 years after the intake interview); New York University Caregiver Intervention
12030630|NCT00362271|Drug|Venlafaxine on Day -4 to day 14, Aripiprazole dosed starting on Day 1: 3 days at 10 mg, 4 days at 1 mg and 7 days at 20 mg.|Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.
12030631|NCT00362258|Drug|Irbesartan (Aprovel)|Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.
12030632|NCT00362245|Drug|Systemic and Intra-Thecal Amikacin Therapy|
12030633|NCT00362232|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.
12030634|NCT00362232|Drug|Enoxaparin|Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
12030635|NCT00362232|Drug|Placebo: tablet of Rivaroxaban|Placebo tablet of rivaroxaban administered once daily in the evening.
12030636|NCT00362232|Drug|Placebo: syringes of Enoxaparin|Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
12030637|NCT00362219|Other|Placebo|Gel with no active ingredient.
12030638|NCT00362219|Drug|Morphine - .25 mg|gel with 0.25 mg morphine per 100cm2 square of wound.
12030639|NCT00362219|Drug|Morphine|Gel with 0.75 mg morphine per 100cm2 square of wound.
12030640|NCT00362219|Drug|Morphine|Gel with 1.25 mg morphine per 100cm2 square of wound.
12030641|NCT00362206|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 20mg
12030642|NCT00362206|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 40 mg
12030643|NCT00362206|Drug|Pravastatin|Pravastatin 40 mg
12030644|NCT00362193|Behavioral|Telephonic diabetes care|
12030645|NCT00362180|Drug|mipomersen|200 mg subcutaneous injections
12030646|NCT00362180|Drug|Placebo|subcutaneous injections
12030647|NCT00362141|Drug|levetiracetam (add-on)|
12030648|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
12030649|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
12030650|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
12030651|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
12030652|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
12030653|NCT00362115|Drug|Olmesartan|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
12030654|NCT00362115|Drug|Placebo|Matching placebo tablets, orally, once daily for up to 8 weeks.
12030655|NCT00362102|Drug|Cetuximab|
12030656|NCT00362089|Dietary Supplement|Marinol D-40|Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
12030657|NCT00362063|Drug|growth hormone (Nutropin)|growth hormone (Nutropin), 0.3mg/kg/week administered subcutaneously daily.
12030658|NCT00362050|Drug|Treatment with 3 dose groups of RBx11160 over 7 days|
12030659|NCT00362037|Drug|Irbesartan (Aprovel)|Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.
12030660|NCT00362024|Drug|MK0952|
12030661|NCT00362024|Drug|Comparator: Placebo|
12030662|NCT00362011|Behavioral|Salba diet|
12030663|NCT00361998|Drug|NITROFURANTOIN MACROCRYSTALS|
12030664|NCT00361985|Drug|Esomeprazole|Esomeprazole 40mg once daily orally.
12030665|NCT00361985|Drug|Esomeprazole|Esomeprazole 40mg once daily orally
12030666|NCT00361972|Drug|lansoprazole|30 mg of lansoprazole twice daily for 6 weeks
12030667|NCT00361972|Drug|placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
12030668|NCT00361959|Drug|Tiotropium bromide 18mcg|
12030669|NCT00361959|Drug|Fluticasone propionate/ salmeterol combination 50/500mcg|
12030670|NCT00361933|Drug|Valganciclovir|valganciclovir open label, two 450mg tablets orally, twice a day
12030671|NCT00361920|Drug|prednisone|
12030672|NCT00361907|Procedure|Effect of Pulsatile IV insulin on diabetic pt blood markers|Diabetic patients are given pulsatile intravenous insulin on a weekly basis determined by weekly physician order based on pt response and insulin resistance.
12030673|NCT00361907|Procedure|Effect of Pulsatile IV Insulin on blood markers|Circulating blood markers are performed at baseline and every twelve months to compare and measure against diabetic patients receiving pulsatile intravenous insulin.
12030674|NCT00361907|Procedure|Effect of Pulsatile IV insulin on diabetic pt blood markers|Blood markers will be performed on diabetic patients enrolled as control patients at baseline and every twelve months to measure and compare against diabetic patients treated with Pulsatile intravenous insulin therapy
12030675|NCT00361894|Drug|Rivaroxaban (BAY59-7939)|10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
12030676|NCT00361894|Drug|Enoxaparin|Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days
12030677|NCT00361881|Drug|ME-609|Cream, dose 5 times daily during 5 days.
12030678|NCT00361881|Drug|acyclovir in ME-609 vehicle|Dose 5 times daily for 5 days
12030679|NCT00361881|Drug|Vehicle|Dose 5 times daily for 5 days
12030680|NCT00361868|Drug|fenofibrate (F) + metformin (M) hydrochloride fixed combination|First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks
12030681|NCT00361868|Drug|Rosiglitazone|First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks
12030682|NCT00361855|Drug|NX-CP105|
12030736|NCT00361387|Drug|d-methylphenidate|oral dosing for 8 weeks then cross over to placebo in random order
12030685|NCT00361790|Drug|Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg|Tablets, Oral, Escitalopram: 10 mg; Aripiprazole: 10, 15, 20 mg, once daily, 14 days.
12030686|NCT00361751|Drug|fenofibrate|
12030687|NCT00361738|Drug|AVE2268|
12030688|NCT00361712|Procedure|Preemptive epidural analgesia|Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.
12030689|NCT00361712|Drug|Standard of care|Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)
12030690|NCT00361699|Drug|Statin|
12030691|NCT00361686|Drug|tramadol|
12030692|NCT00361686|Drug|remifentanyl|
12030693|NCT00361686|Device|patient contolled analgesia|
12030694|NCT00361660|Behavioral|functional task practice - distributed|This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday, Wednesday, and Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
12030695|NCT00361660|Behavioral|functional task practice - condensed|This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday through Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
12030696|NCT00361647|Procedure|Diagnostic screening for occult malignancy|
12030697|NCT00361634|Drug|Etanercept|
12030698|NCT00361621|Drug|bortezomib|Given intravenously on day 1 and day 4 of a 21-day cycle for 6 cycles
12030699|NCT00361621|Drug|Rituximab|Given intravenously on day 1 of a 21-day cycle for 6 cycles
12030700|NCT00361621|Drug|Cyclophosphamide|Given intravenously on day 1 of a 21-day cycle for 6 cycles
12030701|NCT00361621|Drug|Doxorubicin|Given intravenously on day 1 of a 21-day cycle for 6 cycles
12030702|NCT00361621|Drug|Vincristine|Given intravenously on day 1 of a 21-day cycle for 6 cycles
12030703|NCT00361621|Drug|Prednisone|Taken orally on days 2, 3, 4 and 5 or a 21-day cycle for 6 cycles
12030704|NCT00361621|Radiation|Radiation therapy|After 6 cycles of chemotherapy there will be 3 weeks of radiation therapy
12030705|NCT00361608|Device|EarlySense ES 16|
12030706|NCT00361595|Drug|zoledronic acid|5 mg zoledronic acid administered in a single 15 minute IV
12030707|NCT00361582|Drug|CG5503 IR; tapentadol|
12030708|NCT00361569|Drug|DR-2041a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
12030709|NCT00361569|Drug|DR-2041b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
12030710|NCT00361569|Other|Placebo|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
12030711|NCT00361569|Other|Placebo|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
12030712|NCT00361556|Behavioral|The Back Book|A book on how to prevent back pain
12030713|NCT00361556|Behavioral|The Back Guide|A guide for the prevention of back pain.
12030714|NCT00361556|Behavioral|General health book|A book on general health
12030715|NCT00361543|Drug|Raloxifene hydrochloride|120 mg per capsule (1 tablet daily)
12030716|NCT00361543|Other|Lactose Capsules|1 tablet daily for 12 weeks
12030717|NCT00361530|Drug|Statin|
12030718|NCT00361517|Behavioral|Galactomannan antigen monitoring, Aspergillus PCR|There will be blood draws twice weekly for monitoring GM antigen and once a week for Aspergillus PCR.
12030719|NCT00361517|Other|blood draws|Blood is drawn for monitoring of Galactomannan antigen in the blood
12030720|NCT00361517|Other|blood draws for GM monitoring|blood samples will be taken twice weekly for monitoring of GM antigen levels in the blood and once a week for Aspergillus PCR.
12030721|NCT00361517|Drug|Amphotericin-B deoxycholate|1-1.5mg/kg, i.v, once a day
12030722|NCT00361517|Other|blood test|Blood will be tested twice a week for the presence of Galactomannan.
12030723|NCT00361517|Other|Blood test|Blood will be drawn twice a week and it will be tested for the presence of GM(a component of the cell wall of the mold Aspergillus which is released during growth)
12030724|NCT00361504|Drug|Oxycodone CR|Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.
12030725|NCT00361504|Drug|Tapentadol (CG5503) ER|Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.
12030726|NCT00361491|Drug|SSR149415|
12030727|NCT00361478|Behavioral|Exercise and education|Weekly exercise and education program for 8 weeks
12030728|NCT00361478|Behavioral|Education|Written educational material
12030729|NCT00361465|Other|EMG and Kinematics recording|"The experimental protocol envisages the recording of the movement and the bilateral recording of activity EMG during three types of tasks:
~discrete driving tasks: movements of inflection and extension of the wrist car-generated, or produced in answer to an imperative stimulus try driving repetitive: sequence of inflection-extension of the wrist unilateral, bilateral in phase and bilateral in opposition of phase.
~try driving complexes: movement of inflection and extension of the wrist with concurrent realization of a driving task controlatérale different, or of a cognitive task.
~For the Parkinsonian patients, these various tests will be carried out twice: without antiparkinsonian treatment (off) and under treatment (one)."
12030730|NCT00361452|Drug|nebulized epinephrine and nebulized albuterol|
12030731|NCT00361439|Drug|Mometasone|2 puffs in each nostril once daily of nasal spray
12030732|NCT00361439|Drug|Placebo|2 puffs in each nostril once daily of nasal spray
12030733|NCT00361426|Device|Earlysense vital sign monitor|The system is a contactless system that measures heart and respiratory rates and other parameters via a contactless sensor that is placed under the patient mattress
12030734|NCT00361413|Drug|Alefacept (AMEVIVE®)|Alefacept
12030735|NCT00361413|Drug|control group|these patients will receive the same treatment as group A, without alefacept
12031046|NCT00358839|Drug|CGRP|
12030738|NCT00361374|Dietary Supplement|docosahexaenoic acid|1 gram/day
12030739|NCT00361374|Drug|Placebo|980 milligram/day
12030740|NCT00361361|Device|Excimer Laser Therapy|excimer laser is a UV 308nm laser. repeated sessions (10 sessions) needed. once per week.
12030741|NCT00361348|Drug|Palifermin|
12030742|NCT00361348|Drug|Heparin|
12030743|NCT00361335|Drug|Golimumab|2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
12030744|NCT00361335|Drug|Methotrexate|Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.
12030745|NCT00361335|Drug|Placebo|Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
12030746|NCT00361322|Drug|clindamycin phosphate|
12030747|NCT00361322|Drug|salicylic acid|
12030748|NCT00361309|Drug|SU011248|Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks).
12030749|NCT00361296|Biological|K562/GM-CSF cell vaccine|
12030750|NCT00361283|Drug|Atorvastatin|atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
12030751|NCT00361270|Behavioral|Hyp-8|8 weekly 1-hour sessions of therapist-guided hypnosis
12030752|NCT00361270|Behavioral|Hyp-2 w recordings|2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
12030753|NCT00361270|Behavioral|Hyp-8|8 weekly 1-hour sessions of therapist-guided hypnosis
12030754|NCT00361270|Behavioral|Hyp-8 w recordings|8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
12030755|NCT00361270|Behavioral|Hyp-2 w recordings|2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
12030756|NCT00361270|Behavioral|Hyp-8|8 weekly 1-hour sessions of therapist-guided hypnosis
12030757|NCT00361270|Behavioral|Hyp-8 w recordings|8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
12030758|NCT00361270|Behavioral|BIO|8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
12030759|NCT00361257|Drug|Minocycline|Tetracycline antibiotic, 100 mg taken orally every 12 hours
12030760|NCT00361257|Drug|Placebo (Tetracycline)|Tetracycline antibiotic placebo, orally every 12 hours
12030761|NCT00361244|Drug|SU011248|Given orally in the morning for two weeks followed by a one week rest period (one cycle equals 21 days). Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
12030762|NCT00361244|Drug|Irinotecan|Given intravenously on days 1 and 8 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
12030763|NCT00361244|Drug|Cetuximab|Given intravenously on days 8 and 15 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
12030764|NCT00361231|Drug|Bevacizumab|Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
12030765|NCT00361231|Drug|Gemcitabine|Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
12030766|NCT00361231|Drug|Oxaliplatin|Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
12030767|NCT00361218|Drug|open-label selective serotonin reuptake inhibitor (SSRI)|Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.
12030768|NCT00361205|Device|Electronic Monitoring cap|
12030769|NCT00361192|Procedure|biopsy of temporal artery|
12030770|NCT00361166|Drug|ACP-103|
12030771|NCT00361153|Drug|Colesevelam hydrochloride|Welchol tablet 625mg
12030772|NCT00361153|Drug|placebo|placebo
12030773|NCT00361140|Drug|Busulfan|"Bu IV (BusulfexR) over 3 hours on days -6, -5, -4, and -3. Day -6 and -5 doses for patients on Level 1 will be 170mg/m2. This dose is based on the dose used by DeLima (2004) adjusted proportionately to achieve an AUC of 6000uM-min. Subsequent daily doses for patients on Level 1 will be adjusted to achieve an average AUC of 6000uM-min.
~Day -6 and -5 doses for patients on Level 2 will be based on the mean dose required on Level 1 to achieve target AUC then adjusted proportionally for new target AUC.
~Subsequent daily doses will be adjusted to achieve target AUCs."
12030774|NCT00361140|Drug|Fludarabine|Fludarabine 40mg/m2 IV over 1 hour on days -6, -5, -4, and -3
12030775|NCT00361127|Drug|isotonic saline infusion|
12030776|NCT00361114|Drug|sulphadoxine/pyrimethamine|Sulfadoxine/pyremethamine (SP) given as a single dose per manufacturers recommendation (tablets 500mg sulphadoxine and 15mg pyremethamine; child's body weight 5-10Kgs ½ tablet, 11-20Kgs 1 tablet, 21-30 Kgs 1 ½ tablets)
12030777|NCT00361114|Drug|Chlorproguanil/dapsone|Chlorproguanil/ dapsone (CD) given daily for 3 days per manufacturers recommendations (tablets chlorproguanil 15mg/ dapsone 18.75 mg; 5-7.9Kgs 1 tablet, 8-11.9 Kg 1 ½ tablets, 12-15.9 2 tablets, 16-20.9 Kgs 2 ½ tablets, 21- 40Kg 5 tablets).
12030778|NCT00361114|Drug|Sulfadoxine/pyrimethamine|Sulfadoxine/pyremethamine (SP) given as a single dose per manufacturers recommendation (tablets 500mg sulphadoxine and 15mg pyremethamine; child's body weight 5-10Kgs ½ tablet, 11-20Kgs 1 tablet, 21-30 Kgs 1 ½ tablets)
12030779|NCT00361101|Drug|AMD11070|200 mg PO BID (by mouth two times per day) for 10 days.
12030780|NCT00361088|Drug|PS-341|Phase I and II: 1.3mg/m2 iv days 1,4,8,11
12030781|NCT00361088|Drug|R11577|"Phase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3.
~Phase II: Maximum Tolerated Dose (MTD)"
12030782|NCT00361075|Drug|transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium)|
12030783|NCT00361062|Behavioral|comparative computer simulation|comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.
12030784|NCT00361049|Biological|graft versus host disease prophylaxis/therapy|Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.
12030785|NCT00361049|Genetic|fluorescence in situ hybridization|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
12030786|NCT00361049|Other|immunoenzyme technique|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
12030787|NCT00361049|Other|immunohistochemistry staining method|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
12030788|NCT00361049|Other|laboratory biomarker analysis|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
12030789|NCT00361049|Procedure|in vitro-treated bone marrow transplantation|Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.
12030790|NCT00361049|Procedure|management of therapy complications|Patients will be evaluated for clinical signs and symptoms of GVHD weekly for up to 28 days.
12030791|NCT00361036|Device|Uterine fibroid embolization BeadBlock™|Intervention with BeadBlock Microspehere
12030792|NCT00361036|Device|Uterine fibroid embolization Embosphere®|Embosphere - control arm
12030793|NCT00361023|Drug|losartan|
12030794|NCT00361010|Drug|Levetiracetam|
12030795|NCT00360997|Behavioral|Conventional UK physical therapy|
12030796|NCT00360997|Procedure|Con UK PT + Mobilisation & tactile stimulation (MTS)|Con UK PT + Mobilisation & Tactile Stimulation (MTS) which is further randomised to 30, 60 or 120 mins/day
12030797|NCT00360984|Drug|insulin glargine|
12030798|NCT00360984|Device|continuous subcutaneous insulin infusion|
12030799|NCT00360971|Biological|palifermin|Four doses of palifermin, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
12030800|NCT00360971|Drug|cisplatin|Patients will receive cisplatin (100 mg/m2) administered intravenously on days 1, 22, and 43 of the treatment course.
12030801|NCT00360971|Other|placebo|Four doses of placebo, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
12030802|NCT00360971|Procedure|neck dissection|A neck dissection is required for patients with persistent nodal disease, any stage, if a palpable abnormality or worrisome radiographic abnormality persists in the neck 8-9 weeks after completion of therapy. A neck dissection is optional for patients with multiple positive lymph nodes or with lymph nodes exceeding 3 cm in diameter at pre-treatment (N2a, N2b, N3) who achieve a complete clinical and radiographic response in the neck. All patients will be assessed at approximately 8 weeks post-treatment with CT scan or MRI by the same technique used at baseline.
12030803|NCT00360971|Radiation|radiation therapy|A radiation dose of 70 Gy with at least 66 Gy to at least 2 mucosal sites of the oral cavity/oropharynx mucosa. Radiation therapy can be given with 3D conformal (3D-CRT) or with intensity modulated RT (IMRT) techniques; however, the chosen modality must be used for the entire course of treatment.
12030804|NCT00360958|Procedure|ultrafiltration|
12030805|NCT00360945|Drug|cisplatin|
12030806|NCT00360945|Drug|temozolomide|
12030807|NCT00360945|Genetic|fluorescence in situ hybridization|
12030808|NCT00360945|Genetic|loss of heterozygosity analysis|
12030809|NCT00360945|Other|immunohistochemistry staining method|
12030810|NCT00360945|Other|laboratory biomarker analysis|
12030811|NCT00360945|Radiation|radiation therapy|
12030812|NCT00360932|Device|SCULPTRA (poly-L-lactic acid injection)|Subjects will be treated with SCULPTRA® according to the investigator's judgment, and in accordance with the SCULPTRA® package insert. Details of the exact amount and the time of administration of SCULPTRA® (date, amount, location) will be documented in the CRF at each protocol and non-protocol visit.
12030813|NCT00360919|Behavioral|cheese ingestion|"On study day 1, approximately half of the participants will consume a breakfast of fruits and vegetables, whereas the other half of participants will consume a meal consisting of 9 oz. of cheese.
~Blood samples will be collected from participants immediately prior to consumption of the meals, and then again at regular intervals for up to 8 hours following the meals.
~At least 3 days later, participants will return for study Day 2. The participants will receive the second meal. Blood samples will then be collected immediately prior to consumption of the test meal and for up to 8 hours after the meal."
12030814|NCT00360906|Drug|Triomar™ (omega-3 fatty acids)|
12030815|NCT00360867|Drug|AMG 706|The dose of AMG 706 will be administered at the same dose level and schedule received at the conclusion of the previous study but will be no greater than 125 mg QD or 75 mg BID.
12030816|NCT00360854|Drug|erlotinib hydrochloride|
12030817|NCT00360854|Genetic|mutation analysis|
12030818|NCT00360854|Genetic|polymorphism analysis|
12030819|NCT00360854|Other|laboratory biomarker analysis|
12030820|NCT00360854|Other|pharmacological study|
12030821|NCT00360854|Radiation|radiation therapy|
12030822|NCT00360841|Procedure|Auricular acupuncture|Subjects will be randomized to one of these arms. The subjects in arm A and B will receive auricular acupuncture. Before subjects receive chemotherapy within one day, they will be treated by auricular acupuncture, sham acupuncture, or control group.
12030823|NCT00360841|Procedure|Sham auricular acupuncture|
12030824|NCT00360828|Drug|Irinotecan Hydrochloride (HCI) Treatment|Irinotecan injections. Irinotecan hydrochloride [CPT-11; CAMPTOSAR] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 mL vials containing 100 mg of drug. A treatment cycle was 21 days. Patients were treated for a minimum of 3 cycles (doses) of CPT-11 or until their disease progressed.
12030825|NCT00360828|Drug|Continued Irinotecan Hydrochloride (HCI) Treatment|For patients responding to treatment, therapy could have continued beyond 18 cycles.
12030826|NCT00360815|Behavioral|Insulin|
12030827|NCT00360802|Behavioral|Cognitive Behavioral Treatment|Behavioral treatment to reduce pain in chronic back pain patients
12030828|NCT00360802|Behavioral|Mindfulness Based Stress Reduction|Behavioral treatment to reduce pain in chronic back pain patients
12030829|NCT00360789|Behavioral|Conventional UK physical therapy|
12030830|NCT00360789|Behavioral|Increased intensity of UK conventional physical therapy (PT)|
12030831|NCT00360789|Behavioral|UK conventional PT plus functional strength training|
12030832|NCT00360776|Drug|tipifarnib|Given orally
12030833|NCT00360776|Other|laboratory biomarker analysis|Correlative studies
12030834|NCT00360763|Drug|candesartan cilexetil|
12030835|NCT00360750|Drug|carboplatin|
12030836|NCT00360750|Drug|cytarabine|
12030837|NCT00360750|Drug|etoposide|
12030838|NCT00360750|Drug|vincristine sulfate|
12030839|NCT00360750|Other|clinical observation|
12030840|NCT00360750|Procedure|adjuvant therapy|
12030841|NCT00360750|Radiation|radiation therapy|
12030842|NCT00360737|Biological|Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)|Biological/Vaccine NP-018 Experimental with 8 Cohorts of 5 Subjects each evaluating 2 Dosage levels of 1 or 2 vials of NP-018 administered intravenously.
12030843|NCT00360724|Drug|Duloxetine (Cymbalta)|duloxetine medication up to dose of 120 mg/day
12030844|NCT00360698|Drug|Insulin Glargine|One daily injection at bedtime
12030845|NCT00360698|Drug|Glimepiride|At same dosage as during the run-in period
12030846|NCT00360698|Drug|Insulin Glulisine|One bolus given before the main meal
12030847|NCT00360698|Drug|Metformin|At same dosage as during the run-in period
12030848|NCT00360685|Drug|Tac+MTX|Tacrolimus- 0.03mg/kg/24h IV beginning day-3 Methotrexate- 15mg/m2 IV day +1 then 10mg/m2 IV on days 3, 6, 11 post transplant.
12030849|NCT00360685|Drug|TAC + MMF|Tacrolimus- 0.03 mg/kg/24h as a continuous IV infusion, beginning day -3. Mycophenolate Mofetil- 30 mg/kg/day IV in 2 divided doses (q12 hours) beginning day 0 at least 2 hours after the end of the hematopoietic stem cell transplant
12030850|NCT00360672|Drug|Revlimid|25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
12030851|NCT00360659|Device|Continuous Positive Airway Pressure|
12030852|NCT00360607|Drug|Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.|
12030853|NCT00360607|Drug|Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited|
12030854|NCT00360607|Drug|Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.|
12030855|NCT00360607|Drug|Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.|
12030856|NCT00360594|Drug|Acamprosate|3 pills (666 mg) for 1998mg/day
12030857|NCT00360594|Drug|Placebo|3 pills (666mg) for 1998mg/day
12030858|NCT00360581|Behavioral|Yoga|
12030859|NCT00360581|Behavioral|Yoga and Cognitive Behavioral Therapy|
12030860|NCT00360568|Drug|Levodopa-carbidopa intestinal gel|Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).
12030861|NCT00360568|Device|CADD-Legacy® 1400 ambulatory infusion pump|
12030862|NCT00360568|Device|PEG tube|percutaneous endoscopic gastrostomy tube
12030863|NCT00360568|Device|J-tube|jejunal tube
12030864|NCT00360555|Drug|flibanserin|flibanserin 25 mg b.i.d
12030865|NCT00360555|Drug|flibanserin 50mg|flibanserin 50mg qhs/b.i.d.
12030866|NCT00360555|Drug|flibanserin 100mg|flibanserin 50 mg b.i.d/100mg qhs
12030867|NCT00360555|Drug|placebo|placebo comparator
12030868|NCT00360529|Drug|flibanserin|flibanserin placebo versus 50 mg qhs versus 100 mg qhs
12030869|NCT00360516|Behavioral|metabolic (nutrient controlled) diet|metabolic (nutrient controlled) diet
12030870|NCT00360490|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
12030871|NCT00360490|Drug|Medroxyprogesterone acetate|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
12030872|NCT00360477|Procedure|Floseal|Bioglue that seals the kidney
12030873|NCT00360477|Procedure|Cope Loop|Nephrostomy tube for fluid drainage from the kidney
12030874|NCT00360477|Procedure|Fascial Stitch|Stitch that closes the kidney
12030875|NCT00360464|Drug|Azithromycin SR|
12030876|NCT00360451|Behavioral|Adolescent only Penn Resiliency Program (Adolescent PRP)|In adolescent PRP, students learn both cognitive skills (recognizing the link between beliefs and emotions, challenging negative beliefs with evidence, making accurate attributions for events, and accurately assessing the ramifications of negative events) and behavioral problem-solving skills (decision making, assertiveness and negotiation, social skills, and relaxation).
12030877|NCT00360451|Behavioral|Parent Penn Resiliency Program (Parent PRP)|Parent PRP teaches parents to model and reinforce the skills taught in the adolescent program.
12030878|NCT00360438|Drug|Rasburicase|0.15mg/kg intravenously over 30 minutes once per day for 5 consecutive days.
12030879|NCT00360425|Drug|ferumoxytol|
12030880|NCT00360425|Drug|moxifloxacin|
12030881|NCT00360425|Drug|placebo|
12030882|NCT00360412|Drug|E2007|
12030883|NCT00360399|Drug|Escitalopram|Escitalopram 10 to 20 mg per day for 12 weeks
12030884|NCT00360399|Drug|Duloxetine|Duloxetine 30 to 60 mg per day for 12 weeks
12030885|NCT00360399|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include 16 one-hour sessions provided over 12 weeks.
12030886|NCT00360386|Drug|Clopidogrel|
12030887|NCT00360360|Drug|paclitaxel|Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
12030888|NCT00360360|Drug|carboplatin|Carboplatin AUC 6.0 IV Day 1
12030889|NCT00360360|Drug|bevacizumab|Bevacizumab 15mg/kg IV infusion,Day 1
12030890|NCT00360360|Drug|erlotinib|Erlotinib 150 mg by mouth daily
12030891|NCT00360347|Drug|C.E.R.A.|
12030892|NCT00360334|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
12030893|NCT00360334|Drug|insulin glargine|subcutaneous injection, titrated to target blood glucose level, once a day
12030894|NCT00360308|Drug|Placebo|
12030895|NCT00360308|Drug|E2007|
12030896|NCT00360308|Drug|E2007|
12030897|NCT00360295|Drug|Azithromycin SR|
12030898|NCT00360282|Drug|Rizatriptan|10 mg Rizatriptan in an unlabeled pill given once on one of two visits
12030899|NCT00360282|Other|Placebo|In an unlabeled pill given once on one of two visits.
12030900|NCT00360269|Drug|Atomoxetine|25 to 100 mg daily
12030901|NCT00360269|Procedure|Motivational enhancement therapy|Three sessions
12030902|NCT00360269|Drug|Placebo|25 to 100 mg daily
12030903|NCT00360243|Drug|flibanserin|Experimental: flibanserin 25 mg b.i.d
12030904|NCT00360243|Drug|flibanserin|Experimental: flibanserin 50mg qhs
12030905|NCT00360243|Drug|flibanserin|Experimental: flibanserin 50mg b.i.d.
12030906|NCT00360243|Drug|placebo|placebo
12030907|NCT00360230|Biological|GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049|2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
12030908|NCT00360230|Biological|Rabipur|3-dose intramuscular injection.
12030909|NCT00360217|Drug|docosahexanoic acid (DHA)|
12030910|NCT00360204|Behavioral|Home Nurse Visit|Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.
12030911|NCT00360191|Drug|Buspirone|
12030912|NCT00360191|Procedure|Motivational enhancement therapy|
12030913|NCT00360178|Drug|Valsartan plus Hydrochlorothiazide|
12030914|NCT00360178|Drug|Candesartan plus Hydrochlorothiazide|
12030915|NCT00360178|Drug|Amlodipine|
12030916|NCT00360152|Procedure|Fine needle aspiration biopsy (FNAB)|
12030917|NCT00360152|Procedure|Sentinel Lymph Node Biopsy|
12030918|NCT00360139|Device|Sculptra Injection|
12030919|NCT00360126|Drug|lamotrigine|
12030920|NCT00360100|Drug|Zmax|
12030921|NCT00360087|Drug|Bosentan|
12030922|NCT00360074|Drug|Thyroxin, Triiodothyronine|
12030923|NCT00360061|Behavioral|Cognitive Behaviour Therapy|
12030924|NCT00360048|Drug|oxytocin|
12030925|NCT00360035|Drug|Obatoclax mesylate (GX15-070MS)|60 mg q2wks
12030926|NCT00360022|Other|Joint visits|Both the pediatric GI specialist and the adult GI specialist will see the patient together at 2 different visits. The first joint visit is lead by the pediatric MD and the second joint visit is lead by the adult MD.
12030927|NCT00360009|Procedure|DBS of the STN|Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device.
12030928|NCT00360009|Procedure|DBS of the GPI|Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device.
12030929|NCT00359996|Behavioral|health disparities collaborative|The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.
12030930|NCT00359996|Other|No additional educational sessions|
12030931|NCT00359983|Biological|MenHibrix (Hib-MenCY-TT)|First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
12030932|NCT00359983|Biological|Hib conjugate vaccine (ActHIB)|First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
12030933|NCT00359970|Drug|Azithromycin 500 mg|A single 500 mg dose at the start of treatment
12030934|NCT00359970|Drug|Azithromycin 1000 mg|A single 1000 mg dose at the start of treatment
12030935|NCT00359970|Drug|Loperamide|A single 4 mg loading dose at the start of treatment and then 2 mg after each loose stool
12030936|NCT00359970|Other|Placebo|A single loading dose at the start of treatment and then a dose after each loose stool
12030937|NCT00359957|Behavioral|Pediatric Obesity Intervention (STANDARD)|14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
12030938|NCT00359957|Behavioral|Pediatric Obesity Intervention + High Activity (ADDED)|14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
12030939|NCT00359944|Drug|AC-3933|5mg twice daily
12030940|NCT00359944|Drug|AC-3933|AC-3933, 20 mg twice daily
12030941|NCT00359944|Other|Sugar Pill|Sugar Pill twice daily
12030942|NCT00359918|Drug|fibrinolysis|Primary PCI
12030943|NCT00359918|Procedure|Primary PCI|Primary PCI
12030944|NCT00359905|Drug|Silodosin|8 mg daily for 12 weeks
12030945|NCT00359905|Drug|Tamsulosin|0.4 mg daily for 12 weeks
12030946|NCT00359905|Drug|Placebo|once daily for 12 weeks
12030947|NCT00359892|Drug|Obatoclax mesylate (GX15-070MS)|60 mg q2wks
12030948|NCT00359879|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
12030949|NCT00359879|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
12030950|NCT00359866|Radiation|IMRT with tomotherapy|
12030951|NCT00359853|Drug|Oral norfloxacin|
12030952|NCT00359840|Drug|darbepoetin alfa|
12030953|NCT00359814|Drug|Mycophenolatmofetile|Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily
12030954|NCT00359814|Drug|Cyclosporin A|Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
12030955|NCT00359801|Drug|Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care|Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.
12030956|NCT00359801|Drug|Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care|Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
12030957|NCT00359788|Drug|tiotropium|
12030958|NCT00359788|Drug|Combivent (Ipratropium/Albuterol)|
12030959|NCT00359775|Behavioral|Coping Skills Training|6 session behavioral program
12030960|NCT00359762|Drug|exenatide|subcutaneous injection (5mcg or 10mcg), twice a day
12030961|NCT00359762|Drug|glimepiride|oral tablet (titrated to maximally tolerated dose), once daily
12030962|NCT00359736|Drug|sildenafil|Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
12030963|NCT00359723|Drug|methylphenidate|
12030964|NCT00359697|Drug|Hypertonic Saline, Mannitol|
12030965|NCT00359671|Drug|MK6592|MK6592 delivered as a 48-hour CIV as monotherapy in Cycle 1; 48-hour CIV of MK6592 in Cycle 2 and subsequent cycles.
12030966|NCT00359671|Drug|comparator: docetaxel|docetaxel, delivered as a standard IV infusion.
12030967|NCT00359658|Drug|prednisolon|prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
12030968|NCT00359658|Drug|Mycophenolatmofetile|Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
12030969|NCT00359658|Drug|Cyclosporin A|Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 ng/ml
12030970|NCT00359645|Procedure|Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years|
12030971|NCT00359632|Drug|Zyvox - linezolid|Observation and testing in patients for whom their treating physician has determined linezolid is an appropriate therapy. Eye tests performed for subjects who have received linezolid for at least 6 weeks and matching controls who have received other antibiotics for similar types of infections.
12030972|NCT00359632|Drug|Matched control|Matched controls received an antibiotic other than linezolid for at least 6 weeks prior to baseline visit. The control group had only a baseline visit and there were no post baseline study visits.
12030973|NCT00359619|Biological|CervarixTM|Subjects were administered three doses of HPV vaccine
12030974|NCT00359619|Biological|HPV investigational vaccine GSK568893A, different formulations|Subjects were administered three doses of HPV investigational vaccine
12030975|NCT00359606|Drug|5-Fluoro-2-Deoxycytidine (FdCyd)|Given PO and IV
12030976|NCT00359606|Other|Laboratory Biomarker Analysis|Correlative Studies
12030977|NCT00359606|Other|Pharmacological Study|Correlative Studies
12030978|NCT00359606|Drug|Tetrahydrouridine (THU)|Given PO and IV
12030979|NCT00359593|Behavioral|Knowledge translation intervention package|
12030980|NCT00359567|Drug|palonosetron|intravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
12030981|NCT00359567|Drug|granisetron hydrochloride|intravenous injections of palonosetron placebo and then 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
12030982|NCT00359554|Biological|VAXIGRIPPE|
12030983|NCT00359489|Device|cardiac echosonography|
12030984|NCT00359476|Drug|Vinflunine|solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
12030985|NCT00359463|Drug|eltrombopag|Subjects will be administered a single oral dose of 50 mg eltrombopag.
12030986|NCT00359450|Drug|BMS-275183 (oral taxane)|
12030987|NCT00359437|Drug|Satavaptan|oral administration once daily
12030988|NCT00359437|Drug|placebo|oral administration once daily
12030989|NCT00359424|Drug|IV rt-PA alone|Intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy; Group one will receive the standard dose of IV rt-PA given over an hour.
12030990|NCT00359424|Other|endovascular therapy|Group two will receive a lower dose or the standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery. Endovascular therapy can be implemented with or without interarterial rt-PA use.
12030991|NCT00359398|Procedure|Platelet rich plasma sequestration|Venesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma.
12030992|NCT00359385|Drug|Alendronate 70mg weekly|70mg weekly
12030993|NCT00359359|Drug|Sagopilone (BAY86-5302, ZK 219477)|Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
12030994|NCT00359359|Drug|Cisplatin|75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
12030995|NCT00359333|Drug|Gemcitabine , Docetaxel|Gemcitabine 800 mg/m2 IV over 80 minutes on day 1 and day 8, and Docetaxel 60 mg/m2 IV over 60 minutes on day 1 of a 21-day cycle
12030996|NCT00359320|Procedure|pancreaticojejunostomy|
12030997|NCT00359294|Drug|Zalypsis (PM00104)|Intravenously over 1 hour daily for 5 days, every 3 weeks.
12030998|NCT00359281|Drug|atorvastatin|Atrovastatin 20 mg and AEGR-733 10 mg or 60 mg
12030999|NCT00359281|Drug|simvastatin|Simvastatin 20 mg and AEGR-733 10 mg or 60 mg
12031000|NCT00359281|Drug|ezetimibe|Ezetimibe 10 mg and AEGR-733 10 mg
12031001|NCT00359281|Drug|fenofibrate|Micronized Fenofibrate 145 mg and AEGR-733 10 mg
12031002|NCT00359281|Drug|dextromethorphan|Dextromethorphan 30 mg and AEGR-733 10 mg
12031003|NCT00359281|Drug|Extended Release Niacin|1000 mg ER niacin and AEGR-733 10 mg
12031004|NCT00359255|Behavioral|Education manual|The control arm was given education on stroke, the affected arm post strooke, bone health, and healthy living. This information was given in a booklet format and administered once weekly by the site coordinator.
12031005|NCT00359255|Behavioral|An inpatient homework based exercise program for the upper limb post stroke|"The experimental arm was given arm exercises graded based on motor impairment and administered by the site coordinator. The exercises were given in a booklet with written and photographic instructions. These exercises were monitored on a twice-weekly basis.
~The intervention was to be completed once daily for 45 minutes, 5 days per week, and supervised by the site coordinator. Exercises consisted of range of motion, strengthening, and use of the arm in daily activites such as buttoning, pouring and throwing."
12031006|NCT00359242|Behavioral|Infant Sleeping and Soothing|Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.
12031047|NCT00358826|Drug|VIA-2291|oral dosing, 1 time daily for 12 or 24 weeks
12031007|NCT00359242|Behavioral|Repeated Food Exposure|Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
12031008|NCT00359229|Drug|Zolpidem|Administration of Zolpidem 5mg
12031009|NCT00359216|Drug|Mometasone furoate nasal spray|MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning.
12031010|NCT00359216|Drug|Placebo|Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.
12031011|NCT00359203|Device|Dual chamber pacemeker|
12031012|NCT00359190|Drug|lapatinib|GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route
12031013|NCT00359177|Drug|GW679769|GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning
12031014|NCT00359164|Drug|Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab|"Bevacizumab 1.25 mg with verteporfin at Low Fluence (300 mW/cm2 delivered for 83 seconds [light dose of 25 J/cm2]) Photodynamic Therapy.
~Treatment at Baseline visit, followed by an as needed basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham."
12031015|NCT00359164|Drug|Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab|"Bevacizumab 1.25 mg with verteporfin at Low Fluence (150 mW/cm2 delivered for 83 seconds [light dose of 12.5 J/cm2]) Photodynamic Therapy.
~Treatment at Baseline visit, followed by an as needed basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham."
12031016|NCT00359164|Drug|Verteporfin Photodynamic Therapy (SHAM) and bevacizumab|"Bevacizumab with SHAM (150 mW/cm2 delivered for 83 seconds [light dose of 12.5 J/cm2]) Photodynamic Therapy.
~Treatment at Baseline visit, followed by an as needed basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham."
12031017|NCT00359151|Drug|Celecoxib|7 days pre-surgery (excluding day of surgery): 1 celecoxib 200 mg capsule or matching placebo QD; Day of surgery: 2 celecoxib 200 mg capsules or matching placebo within 2 hours prior to surgery, and 1 celecoxib 200 mg capsule or matching placebo following surgery; Post-surgery: starting the day after surgery, 1 celecoxib 200 mg capsule or matching placebo BID for the duration of the study.
12031018|NCT00359151|Drug|Placebo|Placebo once daily (QD) for 7 days pre-surgery (excluding the day of surgery); Placebo within 2 hours prior to surgery; and post surgery on the same day of the surgery; Placebo twice daily (BID) following the day of surgery and for the duration of the study.
12031019|NCT00359138|Drug|desloratadine|5 mg tablet once daily
12031020|NCT00359138|Drug|levocetirizine|5 mg capsule once daily
12031021|NCT00359138|Drug|Desloratadine placebo tablet|once daily
12031022|NCT00359138|Drug|Levocetirizine placebo capsule|once daily
12031023|NCT00359125|Drug|mifepristone (RU-486)|RU-486, 600 mg/day for 1 week.
12031024|NCT00359125|Other|Placebo|Placebo, 600 mg/day for 1 week.
12031025|NCT00359112|Drug|metformin|
12031026|NCT00359112|Drug|sulphonylurea|
12031027|NCT00359112|Drug|Avandamet|
12031028|NCT00359086|Drug|MGCD0103|MGCD0103 given orally three times per week
12031029|NCT00359073|Drug|montelukast|10 mg everyday
12031030|NCT00359073|Drug|placebo|like placebo
12031031|NCT00359060|Behavioral|Physical activity|
12031032|NCT00359047|Behavioral|Documentation|Participants will receive written educational material for themselves as well as the Guidelines document for their physician (same written material as in the Educational Video Group). They will be asked to revisit their physician and provide written documentation inviting him/her to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada
12031033|NCT00359047|Behavioral|Video|Participants will receive a 15-minute educational video on osteoporosis. They will also receive written educational material for themselves and a Guidelines document for their physician. They will be asked to revisit their physician and provide the written documentation inviting her/him to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada. Should participants wish to obtain additional information on osteoporosis, they will be provided with a toll-free number (1-866-571-ROCQ) to contact
12031034|NCT00359021|Drug|TMC125|200 mg twice daily until commercially available
12031035|NCT00358995|Behavioral|Cognitive Behavioral Therapy|Participants will be randomly assigned to either immediate treatment or delayed treatment (three month delay). Participants will then be again be randomly assigned to either Cognitive Behavior Therapy (CBT) or Stress Management Therapy (SMT). The delayed participants (wait list control) will be randomly assigned to either of the two active treatment groups in three months time. Both active treatment conditions involve one hours, individual treatment sessions for 12 consecutive weeks by one of the treating psychologists. All participants will also be asked to complete a package of psychometric questionnaires before treatment.
12031036|NCT00358995|Behavioral|Stress Management Therapy (SMT)|Participants will be randomly assigned to either immediate treatment or delayed treatment (three month delay). Participants will then be again be randomly assigned to either Cognitive Behavior Therapy (CBT) or Stress Management Therapy (SMT). The delayed participants (wait list control) will be randomly assigned to either of the two active treatment groups in three months time. Both active treatment conditions involve one hours, individual treatment sessions for 12 consecutive weeks by one of the treating psychologists. All participants will also be asked to complete a package of psychometric questionnaires before treatment.
12031037|NCT00358982|Drug|MGCD0103|MGCD0103 administered orally three times per wek
12031038|NCT00358969|Drug|guanfacine (Tenex)|
12031039|NCT00358956|Drug|ZD6474 (vandetanib)|100 mg once daily oral tablet
12031040|NCT00358930|Drug|ARQ 501|
12031041|NCT00358917|Drug|lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)|LPV/r 800/200 mg once-daily (QD) tablet
12031042|NCT00358917|Drug|lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)|LPV/r 400/100 mg twice-daily (BID) tablet
12031043|NCT00358878|Drug|Satavaptan|oral administration once daily
12031044|NCT00358878|Drug|placebo|oral administration once daily
12031045|NCT00358852|Other|No intervention|This is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform.
12031048|NCT00358826|Drug|Placebo|oral dosing, 1 time daily for 12 or 24 weeks
12031049|NCT00358813|Drug|Casopitant|Casopitant oral tablets will be available with a dose of 50 milligrams.
12031050|NCT00358800|Device|REMStar Auto with C-Flex|
12031051|NCT00358787|Procedure|Crossed K-wiring of supracondylar fracture of the humerus|Closed reduction of the fracture followed by crossed K wire percutaneous pinning.
12031052|NCT00358787|Procedure|Lateral K-wiring of supracondylar fracture of the humerus|Closed reduction of the fracture followed by lateral K wire percutaneous pinning.
12031053|NCT00358774|Procedure|homeopathic nasal spray|
12031054|NCT00358748|Drug|Hydrocortisone|See detailed description above.
12031055|NCT00358735|Device|ActiveCare CECT device|Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse.
12031056|NCT00358735|Drug|Enoxaparin|Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.
12031057|NCT00358722|Drug|Fermagate|Film coated tablet 500mg
12031058|NCT00358709|Behavioral|Cognitive-Behavioral therapy and Symptom Management|A group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and comparison its effects to a known skills training approach and a control group.
12031059|NCT00358696|Drug|tenofovir|See Detailed Description.
12031060|NCT00358683|Drug|Certolizumab pegol|
12031061|NCT00358670|Biological|infliximab|"Infliximab maintenance therapy
~intravenous (IV) infusion every 8 weeks, 5 mg/kg body weight (first infusion at Week 4/Visit 2)."
12031062|NCT00358670|Biological|infliximab|"Infliximab intermittent therapy:
~Paricipants will receive no infliximab treatment until the Week 26 improvement in PASI from Baseline (original Study P04271 [NCT00251641] Baseline) is reduced by more than 50%. At that time, participants will receive an infliximab infusion, 5 mg/kg body weight. Participants may receive additional infusions at 0, 2, 6, and 14 weeks after the first infusion of the cycle (ie, a maximum of 4 infusions in each infusion cycle) as needed until they respond, defined as a >=75% improvement in PASI from the original Baseline in Study P04271. Subjects will receive no further treatment until they relapse again (ie, improvement in PASI from Baseline is reduced by more than 50%), at which time participants will receive another infusion cycle of up to 4 infusions, as described above. Throughout the study, intermittent treatment infusion cycles will be repeated whenever participants relapse."
12031063|NCT00358657|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplantation
12031064|NCT00358657|Drug|Cyclophosphamide|Given IV
12031065|NCT00358657|Drug|Fludarabine Phosphate|Given IV
12031066|NCT00358657|Other|Laboratory Biomarker Analysis|Correlative studies
12031067|NCT00358657|Drug|Mycophenolate Mofetil|Given PO
12031068|NCT00358657|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic bone marrow transplantation
12031069|NCT00358657|Drug|Sirolimus|Given PO
12031070|NCT00358657|Drug|Tacrolimus|Given IV or PO
12031071|NCT00358657|Radiation|Total-Body Irradiation|Undergo total-body irradiation
12031072|NCT00358644|Drug|Decitabine|20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
12031073|NCT00358631|Drug|SSR149415|
12031074|NCT00358618|Drug|Propofol|See Detailed Description.
12031075|NCT00358605|Device|The Klearway™ oral appliance|See Detailed Description.
12031076|NCT00358592|Device|Mobius™ retractor|
12031077|NCT00358592|Device|traditional metal retraction instruments|
12031078|NCT00358579|Drug|Adrenaline|1 mg
12031079|NCT00358579|Drug|Vasopressin|40 IU
12031080|NCT00358566|Biological|GV1001|0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.
12031081|NCT00358566|Drug|Gemcitabine (Chemotherapy)|Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.
12031082|NCT00358553|Drug|Insulin|
12031083|NCT00358540|Drug|eltrombopag|Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
12031084|NCT00358527|Drug|Mometasone Furoate Nasal Spray (MFNS)|MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days.
12031085|NCT00358527|Other|Placebo|Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days
12031086|NCT00358514|Device|Continuous Compartment Pressure Monitoring|See Detailed Description.
12031087|NCT00358501|Drug|Defibrotide|Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
12031088|NCT00358488|Drug|GSK159797 (10, 15, and 20mcg)|GSK159797 (10, 15, and 20mcg)
12031089|NCT00358488|Drug|salbutamol|salbutamol
12031090|NCT00358488|Drug|salmeterol 50mcg|salmeterol 50mcg
12031091|NCT00358488|Drug|placebo|placebo
12031092|NCT00358475|Drug|GW685698|
12031093|NCT00358462|Drug|Azithromycin|two 500mg tablets or four 250mg tablets administered as a single dose
12031094|NCT00358462|Drug|Doxycycline|one 100mg capsule administered twice daily for seven days
12031095|NCT00358449|Drug|mepolizumab|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg), 2.5 mg/kg , or 10 mg/kg by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
12031096|NCT00358436|Drug|Aclidinium bromide|Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
12031097|NCT00358436|Drug|Placebo|Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
12031098|NCT00358423|Drug|Pegaptanib Sodium|0.3 mg/0.1 ml intravitreal injection, every 6 weeks, up to a total of 3 injections
12031099|NCT00358423|Drug|Control|Sham injections, every 6 weeks, up to a total of 3 sham injections
12031100|NCT00358410|Drug|GW679769 oral tablets|2x GW679769 60mg tablets
12031101|NCT00358410|Drug|Placebo|Placebo oral tablets to match experimental intervention
12031102|NCT00358397|Drug|Clostridium novyi-NT spores|
12031103|NCT00358384|Drug|Pazopanib|Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.
12031104|NCT00358384|Drug|Pazopanib vehicle|Pazopanib vehicle will be given to subjects.
12031105|NCT00358384|Drug|Betamethasone valerate|Betamethasone valerate ointment with 0.1 percent concentration will be given to subjects.
12031106|NCT00358384|Drug|Calcipotriol|Calcipotriol ointment with 0.005 percent concentration will be given to subjects.
12031107|NCT00358371|Drug|flucloxacillin 250 mg|Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
12031108|NCT00358371|Drug|flucloxacillin 500 mg|Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
12031109|NCT00358358|Drug|Fluticasone Propionate/Salmeterol 500/50mcg combination|
12031110|NCT00358358|Drug|Fluticasone Propionate 500mcg|
12031111|NCT00358358|Drug|Salmeterol 50mcg|
12031112|NCT00358332|Biological|FMP2.1/AS02A|FMP2.1 will be reconstituted in AS02A adjuvant. Dosages: 10, 25, or 50 mcg of FMP2.1 or 0.1, 0.25 or 0.5 mL of FMP2.1/AS02A administered by intramuscular injection.
12031113|NCT00358332|Biological|Rabies vaccine (RabAvert)|RabAvert, white, freeze-dried vaccine for reconstitution with diluent. Dosage: 1.0 mL of rabies vaccine.
12031114|NCT00358319|Drug|Karenitecin|
12031115|NCT00358319|Drug|Valproic Acid|
12031116|NCT00358293|Drug|Tizanidine (sublingual or oral)|
12031117|NCT00358280|Drug|Ropivacaine|
12031118|NCT00358280|Drug|Bupivacaine|
12031119|NCT00358267|Procedure|Partial Resection of Inferior Turbinates (PRIT)|PRIT involves surgically removing a small piece off the turbinate, which also reduces its size.
12031120|NCT00358267|Procedure|Radiofrequency Ablation (RFA)|RFA involves inserting a special needle into the inferior (lower) turbinate that releases high frequency energy, which produces heat. The energy and heat cause tissue denaturation (protein damage) and vaporization. The vaporization reduces tissue volume, and denaturation causes healing with scar tissue formation and contraction of surrounding tissue. This procedure can be done under local anesthesia at the doctor's office.
12031121|NCT00358241|Procedure|Nerve block|
12031122|NCT00358228|Drug|Rimonabant|
12031123|NCT00358215|Drug|Darbepoetin alfa|Administered by subcutaneous injection
12031124|NCT00358215|Drug|Placebo|Placebo subcutaneous injection
12031125|NCT00358202|Drug|cefepime|cefepime hydrochloride 1gm IM q24h
12031126|NCT00358202|Drug|ceftriaxone|ceftriaxone 1 gm IM q24h
12031127|NCT00358189|Device|Deep Brain Stimulation|
12031128|NCT00358176|Drug|Risedronate (HMR4003)|
12031129|NCT00358163|Drug|PTK787/ZK 222584|Taken in tablet form daily
12031130|NCT00358163|Drug|paclitaxel|Given as a 3-hour infusion once every 21 days
12031131|NCT00358150|Drug|Eliglustat tartrate|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, then either eliglustat 50 mg BID (if Genz-99067[active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=]5 nanogram per milliliter [ng/mL] on Day 10) or eliglustat 100 mg BID(if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing same treatment through study completion (Year 9). Participant receiving 100 mg BID could be considered for further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
12031132|NCT00358137|Behavioral|Aerobic Conditioning Program|
12031133|NCT00358137|Behavioral|Strength Training Program|
12031134|NCT00358124|Drug|insulin glargine|
12031135|NCT00358124|Drug|rosiglitazone|
12031136|NCT00358124|Drug|metformin|
12031137|NCT00358111|Device|Luma Cervical Imaging System|Colposcopy using LUMA Cervical Imaging System
12031138|NCT00358085|Procedure|Endovascular Repair of Abdominal Aortic Aneurysm|
12031139|NCT00358085|Procedure|Conventional open repair of Abdominal Aortic Aneurysm|
12031140|NCT00358072|Behavioral|Postremission consolidation based on MRD status|Application of combination chemotherapy aimed to reduce MRD burden in unselected patients, followed by MRD-adjusted therapy that range from maintenance chemotherapy (MRD-negative patients) to allogeneic SCT (MRD-positive patients) or high-dose therapy with autologous blood stem cell support (MRD-positive patients without compatible donor for allogeneic SCT)
12031141|NCT00358059|Behavioral|Behavioral Family Systems Therapy for Diabetes|
12031142|NCT00358046|Drug|ILY101|
12031143|NCT00358033|Behavioral|Counseling|
12031144|NCT00358033|Behavioral|Interactive Education|
12031145|NCT00358033|Behavioral|Group Support|
12031146|NCT00358033|Procedure|Pharmacologic case management|Provided by clinical pharmacists
12031147|NCT00358020|Drug|THALIDOMIDE|
12031148|NCT00358020|Drug|BORTEZOMIB|
12031149|NCT00358007|Device|PTV Reduction|The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
12031150|NCT00357994|Drug|Levodopa carbidopa intestinal gel (LCIG)|infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa per/hour)
12031151|NCT00357994|Drug|Placebo gel|
12031152|NCT00357994|Drug|Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets|
12031153|NCT00357994|Drug|Placebo (PBO) oral capsules|
12031154|NCT00357994|Device|CADD-Legacy® 1400 ambulatory infusion pump|
12031155|NCT00357994|Device|PEG tube|percutaneous endoscopic gastrostomy tube
12031156|NCT00357994|Device|J-tube|jejunal tube
12031157|NCT00357981|Drug|ORTHO EVRA, the contraceptive patch|
12031158|NCT00357968|Drug|Prasugrel|Administered orally
12031159|NCT00357968|Drug|Clopidogrel|Administered orally
12031160|NCT00357968|Drug|Placebo for Prasugrel|Administered orally
12031161|NCT00357968|Drug|Placebo for Clopidogrel|Administered orally
12031162|NCT00357955|Behavioral|Behavioral counseling and peer support|Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
12031163|NCT00357955|Behavioral|Interactive Education|interactive lectures with hands-on learning
12031164|NCT00357955|Behavioral|Role modeling|learning from peers with similar disease and problems
12031165|NCT00357955|Procedure|Pharmacologic case management|provided by clinical pharmacists following pre-established algorithms
12031166|NCT00357942|Drug|morphine solution for injection|morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
12031167|NCT00357942|Drug|Placebo|Placebo mouthwash
12031168|NCT00357942|Drug|morphine mouthwash|morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
12031169|NCT00357942|Drug|Placebo|Placebo solution for injection every 3 hour for 24 hours
12031170|NCT00357929|Procedure|Permissive hypercarbia|
12031171|NCT00357916|Drug|PEP005 Topical Gel (0.01% concentration)|
12031172|NCT00357903|Biological|Etanercept|Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).
12031173|NCT00357890|Device|Pump therapy (CSII)|CSII initiated within 1 month of dx
12031174|NCT00357890|Drug|Multiple daily injections (MDI) using insulin glargine + rapid acting analog|MDI as control
12031175|NCT00357877|Drug|10% w/v chlorhexidine acetate coating FDA IND #45466|Dental coating topically applied by dental professional supragingivally to the full dentition
12031176|NCT00357877|Other|Placebo|
12031177|NCT00357864|Drug|carbachol|
12031178|NCT00357851|Drug|Aprotinin|
12031179|NCT00357825|Drug|[S,S]-Reboxetine|
12031180|NCT00357799|Device|VeinViewer|Using the VeinViewer, IV attempts will be made
12031181|NCT00357786|Drug|Replagal agalsidase alfa|
12031182|NCT00357786|Drug|Replagal|
12031183|NCT00357773|Drug|Azithromycin (T1225)|
12031184|NCT00357760|Biological|VEGF Trap|Given IV
12031185|NCT00357747|Drug|AEG35156|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
12031186|NCT00357747|Drug|docetaxel|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
12031187|NCT00357734|Drug|Gefitinib|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
12031188|NCT00357721|Drug|Atazanavir Sulphate|Capsules, Oral, 200 mg, twice daily, 7 days.
12031189|NCT00357721|Drug|Atazanavir Sulphate|Capsules, Oral, 300 mg, twice daily, 8 days.
12031190|NCT00357721|Drug|Atazanavir Sulphate|Capsules, Oral, 400 mg, twice daily, 9 days.
12031191|NCT00357708|Drug|decitabine|Given IV
12031192|NCT00357708|Drug|vorinostat|Given orally
12031193|NCT00357708|Other|laboratory biomarker analysis|Correlative studies
12031194|NCT00357708|Other|pharmacological study|Correlative studies
12031195|NCT00357682|Drug|Esomeprazole|20mg per day
12031196|NCT00357682|Drug|Esomeprazole|80mg per day
12031197|NCT00357682|Drug|Aspirin|300mg per day
12031198|NCT00357669|Drug|Brivaracetam 25 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Tablet
~Concentration: 25 mg
~Route of Administration: Oral use"
12031199|NCT00357669|Drug|Brivaracetam 50 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Tablet
~Concentration: 50 mg
~Route of Administration: Oral use"
12031200|NCT00357669|Other|Placebo|"Active Substance: Placebo Pharmaceutical Form: Tablet
~Concentration: 25 mg and 50 mg
~Route of Administration: Oral use"
12031201|NCT00357656|Drug|Recombinant Protein-Free Factor VIII (rAHF-PFM)|"An initial loading dose will be administered intravenously over a period <= 5 minutes (maximum of infusion rate of 10 mL/minute) within 60 minutes prior to surgery dose in order to maintain a minimum target FVIII level of at least 80% of normal.
~CI will start prior to surgery as soon as the loading dose has been administered, at a rate calculated according to a formula provided by the sponsor.
~All study product must be administered with a syringe pump running at an infusion rate according to the dosing regimen, but always >= 0.4 mL/h."
12031202|NCT00357656|Drug|Recombinant Protein-Free Factor VIII (rAHF-PFM)|The treatment schedule for intermittent BI of rAHF-PFM will begin with the administration of the loading dose according to the dose recommendations provided by the sponsor. If required by the hemostatic challenge, additional boluses may be administered after a blood sample for FVIII determination has been drawn. All infusions of rAHF PFM will be given over a period <= 5 minutes (maximum infusion rate, 10 mL/min).
12031203|NCT00357643|Drug|Calcium 500 mg/day and vitamin D 700 IU/day|
12031204|NCT00357630|Drug|gemcitabine hydrochloride|
12031205|NCT00357630|Procedure|quality-of-life assessment|
12031206|NCT00357617|Drug|celecoxib|
12031207|NCT00357617|Genetic|microarray analysis|
12031208|NCT00357617|Genetic|protein expression analysis|
12031209|NCT00357617|Other|immunoenzyme technique|
12031210|NCT00357617|Other|immunohistochemistry staining method|
12031211|NCT00357617|Other|laboratory biomarker analysis|
12031212|NCT00357617|Procedure|biopsy|
12031213|NCT00357617|Procedure|conventional surgery|
12031214|NCT00357617|Procedure|neoadjuvant therapy|
12031215|NCT00357604|Drug|Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)|Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.
12031216|NCT00357604|Drug|Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days|Tablets + Capsules/Capsules, Oral, (25 mcg of EE + 0.18/0.215/0.25 mg of NGM) + 300/100 mg then 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 21 days.
12031217|NCT00357591|Device|Continuous Aortic Flow Augmentation|1.0-1.5 lpm augmented blood flow
12031218|NCT00357565|Biological|filgrastim|All patients will receive G-CSF 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days and then discontinued. If the ANC decreases to <1.0 x 10^9/L, G-CSF will be reinstituted.
12031219|NCT00357565|Drug|busulfan|Administered 1.1 mg/kg if <12 kg intravenous (IV) every 6 hours (0.8 mg/kg if >12 kg IV every 6 hours on Days -8 through -5.
12031220|NCT00357565|Drug|cyclosporine|Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of >200 ng/mL. For children < 40 kg the initial dose will be 2.5 mg/kg intravenous (IV) over 2 hours every 8 hours.
12031221|NCT00357565|Drug|fludarabine phosphate|Administered 25 mg/m^2 intravenous (IV) over 60 minutes on Days -4 through -2.
12031222|NCT00357565|Drug|melphalan|Administered 60 mg/m^2 intravenous (IV) over 30 minutes on Days -4 through -2.
12031223|NCT00357565|Drug|mycophenolate mofetil|All patients will begin mycophenolate mofetil (MMF) on day -3. Patients <45 kilograms will receive MMF at the dose of 15 mg/kg/dose every 8 hours (max dose 1gm/dose) orally or intravenously (PO or IV).
12031224|NCT00357565|Procedure|umbilical cord blood transplantation|The product is infused via IV drip directly into the central line without a needle, pump or filter on Day 0.
12031225|NCT00357552|Drug|Emtricitabine/Tenofovir disoproxil fumarate|Once daily
12031226|NCT00357552|Drug|Lopinavir/Ritonavir|Twice daily
12031227|NCT00357539|Drug|Azithromycin (T1225)|
12031228|NCT00357526|Drug|OCPs|
12031229|NCT00357526|Device|vaginal ring|
12031230|NCT00357500|Drug|celecoxib|
12031231|NCT00357500|Drug|cyclophosphamide|
12031232|NCT00357500|Drug|etoposide|
12031233|NCT00357500|Drug|fenofibrate|
12031234|NCT00357500|Drug|thalidomide|
12031235|NCT00357487|Device|peroperative scintillating probe|
12031236|NCT00357487|Device|operative gamma camera|
12031237|NCT00357474|Procedure|Transarterial chemoembolization|lipiodol, adriamycin and/or mitomycin
12031238|NCT00357474|Procedure|Percutaneous ethanol injection therapy|99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week
12031239|NCT00357461|Biological|gp100:209-217(210M) peptide vaccine|
12031240|NCT00357461|Biological|gp100:280-288(288V) peptide vaccine|
12031241|NCT00357461|Biological|incomplete Freund's adjuvant|
12031242|NCT00357461|Biological|ipilimumab|
12031243|NCT00357448|Biological|denileukin diftitox|Given IP at 3 dose levels: 5mcg/kg of ONTAK, 15mcg/kg of ONTAK, or 25mcg/kg of ONTAK
12031244|NCT00357448|Procedure|intraperitoneal administration|After completion of I.P. normal saline infusion, the I.P. catheter will be capped and patients will be turned/rotated for 1 hour to help facilitate I.P. bathing w/ONTAK; patients will be turned/rotated every 15 minutes in 4 different positions for a total of 1 hour
12031245|NCT00357448|Other|laboratory biomarker analysis|Correlative studies
12031246|NCT00357448|Other|enzyme-linked immunosorbent assay|Correlative studies
12031247|NCT00357448|Other|flow cytometry|Correlative studies
12031248|NCT00357422|Procedure|Operation|No drug needed
12031249|NCT00357422|Procedure|Percutaneous ethanol injection therapy|99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week
12031250|NCT00357396|Biological|graft versus host disease prophylaxis/therapy|
12031251|NCT00357396|Drug|busulfan|
12031252|NCT00357396|Drug|melphalan|
12031253|NCT00357396|Drug|thiotepa|
12031254|NCT00357396|Procedure|allogeneic bone marrow transplantation|
12031255|NCT00357396|Procedure|allogeneic hematopoietic stem cell transplantation|
12031256|NCT00357396|Procedure|peripheral blood stem cell transplantation|
12031257|NCT00357383|Drug|Azithromycin (T1225)|
12031258|NCT00357370|Drug|Dapagliflozin|Tablets, Oral, once daily, up to 12 weeks
12031259|NCT00357370|Drug|Placebo|Tablets, Oral, 0 mg, once daily, up to 12 weeks
12031260|NCT00357357|Drug|HF0220|comparison of different dosages of drug
12031261|NCT00357331|Drug|potassium citrate|20 meq by mouth in capsule form twice daily
12031262|NCT00357318|Drug|sunitinib malate|Given PO
12031263|NCT00357318|Biological|bevacizumab|Given IV
12031264|NCT00357318|Other|pharmacological study|Correlative studies
12031265|NCT00357318|Other|laboratory biomarker analysis|Correlative studies
12031266|NCT00357305|Drug|vorinostat|Given orally
12031267|NCT00357305|Drug|cytarabine|Given IV
12031268|NCT00357305|Drug|etoposide|Given IV
12031269|NCT00357305|Other|pharmacological study|Correlative studies
12031270|NCT00357305|Other|laboratory biomarker analysis|Correlative studies
12031271|NCT00357292|Drug|Azithromycin (T1225)|
12031272|NCT00357279|Drug|denufosol tetrasodium (INS37217) Inhalation Solution|Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.
12031273|NCT00357279|Drug|Placebo - 0.9% w/v sodium chloride solution|4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
12031274|NCT00357253|Drug|capecitabine|This is a dose escalation study. 375, 500, 650, or 850 mg/m2 capecitabine RDT is given orally daily in two divided doses approximately 12 hours apart beginning at the start of radiation therapy and continuing for 9 weeks. After a two week break, patients receive twice daily oral capecitabine, either 900 mg/m2 or 1250 mg/m2, approximately 12 hours apart for 14 days followed by a 7-day rest period for a total of 3 courses.
12031275|NCT00357253|Radiation|radiation therapy|Participants receive local radiation once daily, 5 days/week for 9 weeks for a total dose of 5580 cGy.
12031276|NCT00357240|Drug|Atazanavir|Capsules, Oral, 400 mg, once daily, 6 days.
12031277|NCT00357240|Drug|Atazanavir/Ritonavir|Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
12031278|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
12031335|NCT00356785|Behavioral|health education|
12031336|NCT00356785|Behavioral|food supplementation|
12031279|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
12031280|NCT00357240|Drug|Atazanavir|Capsules, Oral, 400 mg, once daily, 6 days.
12031281|NCT00357240|Drug|Atazanavir/Ritonavir|Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
12031282|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.
12031283|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.
12031284|NCT00357214|Dietary Supplement|Potassium Bicarbonate|67.5 mmol/d given as three tablets after each meal, with a full glass of water
12031285|NCT00357214|Dietary Supplement|Sodium Bicarbonate|67.5 mmol/d given as three tablets after each meal, with a full glass of water
12031286|NCT00357214|Dietary Supplement|Potassium Chloride|67.5 mmol/d given as three tablets after each meal, with a full glass of water
12031287|NCT00357214|Dietary Supplement|placebo (microcrystalline cellulose)|Given as three tablets after each meal, with a full glass of water
12031288|NCT00357201|Drug|Food supplement (T1675)|
12031289|NCT00357188|Drug|Atazanavir Sulphate + Ritonavir|Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
12031290|NCT00357188|Drug|Atazanavir Sulphate + Ritonavir + Efavirenz|Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
12031291|NCT00357162|Drug|belinostat|Given IV
12031292|NCT00357149|Drug|Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy|
12031293|NCT00357149|Drug|Concomitant cisplatin, 5-FU and radiotherapy|
12031294|NCT00357136|Behavioral|password usage|
12031295|NCT00357123|Drug|Rosuvastatin|20 mg 10 days daily since abdominal sepsis diagnosis
12031296|NCT00357110|Drug|Fulvestrant|intramuscular injection
12031297|NCT00357110|Drug|Anastrozole|1 mg oral tablet
12031298|NCT00357097|Drug|Ropinirole|
12031299|NCT00357084|Drug|methotrexate|
12031300|NCT00357084|Drug|methylprednisolone|
12031301|NCT00357084|Drug|prednisone|
12031302|NCT00357045|Drug|Paroxetine|
12031303|NCT00357032|Drug|belinostat|Given IV
12031304|NCT00357032|Other|laboratory biomarker analysis|Correlative studies
12031305|NCT00357019|Drug|N-acetyl-aspartyl-glutamate (NAAXIA Sine)|
12031306|NCT00357006|Drug|Estradiol|100 mcg adjunctive transdermal estradiol
12031307|NCT00357006|Drug|Estradiol|200 mcg adjunctive transdermal estradiol
12031308|NCT00357006|Other|placebo|adjunctive transdermal placebo
12031309|NCT00356993|Drug|Nicotine Replacement Therapy|transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
12031310|NCT00356993|Behavioral|behavioural intervention|Smoking cessation counselling, relapse prevention strategies
12031311|NCT00356980|Biological|colloidal gold-bound tumor necrosis factor|
12031312|NCT00356980|Other|pharmacological study|
12031313|NCT00356967|Drug|dianicline|
12031314|NCT00356954|Drug|N-acetylcystein|
12031315|NCT00356954|Drug|ascorbic acid|
12031316|NCT00356941|Drug|docetaxel|60 mg/m2 on day 1 of each week during radiation therapy
12031317|NCT00356941|Drug|oxaliplatin|Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy
12031318|NCT00356941|Procedure|radiation therapy|2 Gy Days 1-5 each week, total dose of 70Gy
12031319|NCT00356928|Drug|Cyclophosphamide|50 mg/kg/day intravenously (IV) on Days -2 and -1.
12031320|NCT00356928|Biological|Donor T cells|"CD8-depleted T cells given IV on Day 0. Dose levels are as follows (all doses in cells/kg):
~Dose level 1: 1E5 CD4+ cells and less than 3.2E3 CD8+ cells Dose level 2: 1E6 CD4+ cells and less than 3.2E4 CD8+ cells Dose level 3: 1E7 CD4+ cells and less than 3.2E5 CD8+ cells Dose level 4: 5E7 CD4+ cells and less than 1.6E6 CD8+ cells"
12031321|NCT00356915|Drug|Itraconazole 100mg capsules|Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.
12031322|NCT00356915|Drug|Itraconazole 200mg tablets|Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
12031323|NCT00356915|Drug|Placebo tablets|Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.
12031324|NCT00356902|Procedure|titration of oxygen during resuscitation|
12031325|NCT00356889|Drug|erlotinib hydrochloride|Given orally, 150 mg, once daily.
12031326|NCT00356889|Biological|bevacizumab|Given IV, 5mg/kg on days 1 and 15 every cycle
12031327|NCT00356863|Behavioral|Increasing awareness to cardiac rehabilitation programs|Increasing awareness to cardiac rehabilitation programs: Before coronary artery bypass grafting (CABG) surgery patients received a face-to-face explanation on their right to participate in cardiac rehabilitation programs (CRPs) under the Israeli Basket of Health Services; they were also provided with a brochure on the benefits of CRP participation and the availability of CRPs throughout the country.
12031328|NCT00356850|Drug|Azithromycin|
12031329|NCT00356837|Procedure|Ultrasound|use ultrasound to confirm diagnosis of extremity fractures
12031330|NCT00356824|Drug|Amodiaquine|200 mg oral tablet taken daily for 3 days under direct supervision at study clinic
12031331|NCT00356824|Drug|Artesunate|50 mg oral tablet taken daily for 3 days under direct supervision at study clinic
12031332|NCT00356811|Drug|Lapatinib oral tablets|Lapatinib will be given as tablets contain 410 mg of lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib free base per tablet. Subjects will be given a 4 week supply of lapatinib tables and instructed to take 6 tablets daily (1500 mg daily dose) orally at the same time each day. Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
12031333|NCT00356811|Drug|Paclitaxel infusion|Subjects will receive weekly paclitaxel (80 mg/m2 IV for 3 weeks in a 4 week cycle). Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent.
12031334|NCT00356798|Biological|an inactivated whole virion H5N1 vaccine, adjuvanted|
12031337|NCT00356785|Behavioral|food supplementation combined with physical activity program|
12031338|NCT00356772|Drug|Azithromycin|
12031339|NCT00356759|Drug|Dosing warfarin every 12 weeks, sham INRs 2 out of 3 times|Warfarin is dosed according to INR to maintain INR 2.0-3.0 or for mechanical mitral valves or mechanical aortic valves with atrial fibrillation INR 2.5-3.5
12031340|NCT00356733|Drug|Erythropoietin administration|50 IU/kg/week EPO to a target haemoglobin level of 13.7 g/dL for men and 13.4 g/dL for women (group A) or to a target comparable to starting hemoglobin level (group B)
12031341|NCT00356720|Drug|Azithromycin|
12031342|NCT00356681|Drug|AMG 706 placebo|Blinded placebo
12031343|NCT00356681|Drug|Bevacizumab|Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
12031344|NCT00356681|Drug|AMG 706|AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.
12031345|NCT00356681|Drug|Paclitaxel|Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
12031346|NCT00356668|Device|High Flow Nasal Cannula|30 minute blocks on varying flows of high flow nasal cannula
12031347|NCT00356655|Behavioral|Psychoeducation|
12031348|NCT00356642|Drug|GW842470X|GW842470X will be available as a yellow smooth water-in-oil cream.
12031349|NCT00356642|Drug|Placebo|GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
12031350|NCT00356616|Drug|Trizivir (AZT+3HT+Abacavir) twice daily|Trizivir (AZT+3HT+Abacavir) twice daily
12031351|NCT00356616|Drug|Viread (300 mg Tenofovir disoproxil fumarate) once daily|Viread (300 mg Tenofovir disoproxil fumarate) once daily
12031352|NCT00356603|Drug|Sumatriptan Succinate|Sumatriptan Succinate
12031353|NCT00356590|Biological|Etanercept|Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.
12031354|NCT00356564|Biological|hepatitis B vaccine|
12031355|NCT00356551|Behavioral|Family Spirit curriculum|
12031356|NCT00356525|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
12031357|NCT00356525|Drug|gemcitabine|1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
12031358|NCT00356525|Drug|carboplatin|area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
12031359|NCT00356525|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
12031360|NCT00356486|Drug|Peginterferon alfa-2a, Ribavirin, epoetin-β|Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks
12031361|NCT00356486|Drug|Peginterferon alfa-2a + Ribavirin for 12 weeks|Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
12031362|NCT00356473|Drug|Atorvastatin|
12031363|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 0.1 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 0.1 mg/kg IV (one dose every 14 days)
12031364|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 0.3 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 0.3 mg/kg IV (one dose every 14 days)
12031365|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 1.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 1.0 mg/kg IV (one dose every 14 days)
12031366|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 3.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 3.0 mg/kg IV (one dose every 14 days)
12031367|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 10.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 10.0 mg/kg IV (one dose every 14 days)
12031368|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 15.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 15.0 mg/kg IV (one dose every 14 days)
12031369|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ ) Monoclonal Antibody|1 dose of 15.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 15.0 mg/kg IV (one dose every 14 days)
12031370|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 15.0 or 10.0 mg/kg IV (based on safety profile of part 2, cohort 1) followed by a 28 day observation period and then 3 additional doses of 15.0 or 10.0 mg/kg IV (one dose every 14 days)
12031371|NCT00356447|Drug|Estradiol/DRSP (Angeliq, BAY86-4891)|Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.
12031372|NCT00356447|Drug|Placebo|Same administration.
12031373|NCT00356434|Device|Kendall A-V foot impulse pump, model 6060|Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use
12031374|NCT00356434|Device|Kendall sequential compression device, model 9525|Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use
12031375|NCT00356421|Drug|Inhaled Human Insulin (Exubera®)|Preprandial inhaled insulin regimen and administration of insulin glargine QD
12031376|NCT00356421|Drug|Insulin lispro (Humalog)|Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
12031377|NCT00356408|Biological|Certolizumab pegol|"Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).
~Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2."
12031378|NCT00356395|Drug|ramipril, candesartan|
12031379|NCT00356382|Drug|Lactobacillus (L.) casei|
12031380|NCT00356369|Biological|meningococcal ACWY (vaccine)|One intramuscular dose.
12031381|NCT00356369|Biological|Mencevax™ ACWY|One subcutaneous dose.
12031382|NCT00356356|Drug|Etanercept|Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites
12031383|NCT00356343|Device|NMES Strength Training|Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
12031384|NCT00356343|Other|Volitional Strength Training|Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
12031385|NCT00356317|Behavioral|Culturally informed therapy for schizophrenia (CIT-S)|This family therapy consists of 15 video-taped, therapy sessions, each lasting approximately 75 minutes. The 15-session treatment will be broken down into five segments (each lasting approximately three sessions) with the following goals: 1) Fortify a strong sense of family unity; 2) educate about schizophrenia; 3) foster adaptive use of cultural, spiritual and/or existential beliefs in conceptualizing and coming to terms with schizophrenia; 4) teach effective communication training techniques; and 5) and teach useful problem solving strategies.
12031386|NCT00356317|Behavioral|Psychoeducation treatment as usual|This family therapy consists of three weekly sessions focusing on education about schizophrenia.
12031387|NCT00356304|Behavioral|Motivational interviewing|Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration.
12031388|NCT00356304|Behavioral|Treatment as usual|Participants will continue with their normal treatment regimen as usual.
12031389|NCT00356291|Behavioral|Skill-Building (SB) plus Motivational Interviewing|SB is a 4 to 5 session individually-based psychoeducational intervention. Participants meet weekly with an interventionist for 3 to 4 weeks and then receive a booster session 3 months after baseline. The traditional Skill-Building intervention will be augmented with Motivational Interviewing techniques.
12031390|NCT00356291|Behavioral|Skill-Building (SB)|SB is a 4-session individually-based psychoeducational HIV risk reduction intervention. Participants meet weekly with an interventionist for 3 weeks and then receive a booster session 3 months after baseline.
12031391|NCT00356278|Drug|D-Cycloserine|D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
12031392|NCT00356278|Drug|Alprazolam|Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
12031393|NCT00356278|Behavioral|Virtual Reality Exposure Therapy|VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
12031394|NCT00356278|Drug|Placebo|Placebo will be administered in the same manner as the active drugs.
12031395|NCT00356265|Drug|Procedure: Regional phenylephrine arterial infusion|
12031396|NCT00356252|Drug|mixed carotenoids|
12031397|NCT00356226|Drug|clonidine|
12031398|NCT00356213|Procedure|sleeve gastrectomy|laparoscopic sleeve gastrectomy
12031399|NCT00356213|Procedure|Roux-Y-gastric bypass|laparoscopic gastric bypass
12031400|NCT00356200|Drug|Fluphenazine Decanoate|"Fluphenazine decanoate marketed by APP Pharmaceuticals (25 mg/mL, 5 mL vial) was used in this study. This was an ascending dose study with the first cohort of 5 subjects dosed at 10 µg/mL, followed by 5 subject dosed in the second cohort at 100 µg/mL. Note: APP Pharmaceuticals is the name of the pharmaceutical company; APP is not an acronym."
12031401|NCT00356200|Drug|Placebo|The sterile placebo (sesame oil with 1.2% (w/v) benzyl alcohol) was prepared at the University of Iowa, Division of Pharmaceutical Services, a FDA registered pharmaceutical manufacturing facility.
12031402|NCT00356187|Drug|Propranolol|
12031403|NCT00356161|Device|interventionally implanted hepatic arterial port catheter|
12031404|NCT00356148|Drug|Ampicillin/Sulbactam|Ampicillin/Sulbactam 1 gr, once within onr hour before surgery
12031405|NCT00356135|Drug|prasugrel 10 mg|10 mg tablet taken orally
12031406|NCT00356135|Drug|clopidogrel|75 mg tablet taken orally
12031407|NCT00356135|Drug|prasugrel placebo|oral, as blinding mechanism.
12031408|NCT00356135|Drug|prasugrel 60 mg|60 mg (six 10-mg tablets) taken orally
12031409|NCT00356135|Drug|clopidogrel placebo|oral, as blinding mechanism
12031410|NCT00356122|Drug|Docetaxel|70 mg/m^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks)
12031411|NCT00356122|Drug|Oxaliplatin|100 mg/m^2 administered IV on Day 1 for Cycles 1-6
12031412|NCT00356122|Drug|Bevacizumab|15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of one year, until disease progression or death due to any cause, whichever occurs first.
12031413|NCT00356109|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 6 months
12031414|NCT00356109|Drug|Injectable insulin|patient specific dose, injected, before meals, 6 months
12031415|NCT00356109|Drug|Insulin Glargine|patient specific dose, injectable, before meals, 6 months
12031416|NCT00356096|Drug|pramipexole|
12031417|NCT00356083|Drug|Methadone|
12031418|NCT00356070|Drug|Strattera|
12031419|NCT00356057|Device|Protos DR/CLS and Stratos LV CRT pacemakers|Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption
12031420|NCT00356044|Procedure|Coronary angioplasty|
12031421|NCT00356031|Drug|Bevacizumab|Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
12031422|NCT00356031|Radiation|Radiation Therapy|External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
12031481|NCT00355576|Drug|Creatine|10 g BID for either study arm
12031423|NCT00356031|Procedure|Surgery|Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.
12031424|NCT00356018|Behavioral|Compliance|
12031425|NCT00356005|Drug|azithromycin plus artesunate|
12031426|NCT00356005|Drug|Artesunate|
12031427|NCT00355979|Device|intragastric balloon|
12031428|NCT00355966|Drug|Misoprostol|In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
12031429|NCT00355966|Drug|PGE2 gel|In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.
12031430|NCT00355953|Drug|Genistein|
12031431|NCT00355940|Device|Technological Methods|"Usage of technological methods and devices to improve intravascular navigation during endovascular aortic repair.
~In this arm we first use an optical pointer to allocate the femoral artery ramification (point of incision) and the lower renal artery (upper confinement of stent graft). Later we use an electromagnetically tracked catheter to find and enter the opening in the main stent graft before placing the second limb. For both optical and electromagnetic tracking we use a custom made navigation system based on 3 dimensional CT images"
12031432|NCT00355940|Device|Regular Fluoroscopy|Usage of conventional fluoroscopy and angiography for intravascular navigation. In this arm standard endovascular aortic repair is performed. The only means of navigation are fluoroscopy and angiography with overlay function (standard).
12031433|NCT00355927|Procedure|Sedation with IV propofol|Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved
12031434|NCT00355914|Procedure|Lumbar Facet Joint Nerve Block|Lumbar Facet Joint Nerve Block
12031435|NCT00355901|Drug|Visilizumab (Nuvion®; HuM291)|
12031436|NCT00355888|Drug|MBP-426|Dose escalation starting at 6 mg/m2, IV (in the vein) on Day 1 of each 21-day cycle. Number of Cycles: Up to 6 cycles, until unacceptable toxicity, disease progression, or intercurrent illness requires treatment discontinuation. Patients may continue treatment beyond 6 cycles if the Investigator determines that additional treatment would provide further benefit for the patient as long as toxicity remains acceptable.
12031437|NCT00355875|Procedure|titration of oxygen during resuscitation|
12031438|NCT00355862|Drug|CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)|center specific therapeutic regimen without mTOR inhibition
12031439|NCT00355862|Drug|Sirolimus|Sirolimus based immunosuppression
12031440|NCT00355849|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 52 weeks
12031441|NCT00355849|Drug|Insulin Glargine|patient specific dose, injectable, before meals, 52 weeks
12031442|NCT00355836|Behavioral|Mental Imagery|
12031443|NCT00355810|Dietary Supplement|placebo followed by Lactobacillus plantarum MF 1298|placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks
12031444|NCT00355810|Dietary Supplement|Lactobacillus plantarum MF1298 followed by placebo|Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks
12031445|NCT00355797|Device|Closed Loop Stimulation (CLS)|Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the Closed Loop Stimulation (DDD-CLS or VVI-CLS) pacing mode for the long-term follow-up portion of this study.
12031446|NCT00355797|Device|Standard Rate Adaptive (R) Technology|Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the standard are adaptive pacing mode (DDDR or VVIR) for the long-term follow-up portion of this study.
12031447|NCT00355797|Device|Non-rate adaptive (DDD) pacing|Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the non-rate adaptive pacing mode (DDD or VVI) for the long-term follow-up portion of this study.
12031448|NCT00355784|Other|overfeeding|overfeeding 2000kcals/day above energy requirements for 14d
12031449|NCT00355784|Drug|growth hormone treatment|growth hormone administrated for 2 weeks (dose = 1.0 mg/m2/d)
12031450|NCT00355771|Drug|Levocetirizine|Intake of 1 tablet of Levocetirizine 5mg OD for 8 weeks
12031451|NCT00355771|Drug|Placebo|1 tablet OD in the morning for 8 weeks
12031452|NCT00355745|Device|Ultrasound breast scanning|breast scanning
12031453|NCT00355732|Procedure|Weaning from mechanical ventilation|
12031454|NCT00355719|Drug|Atazanavir (Reyataz)|Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h)
12031455|NCT00355719|Drug|Ritonavir (Norvir)|Ritonavir (Norvir): capsules 100 mg (1 capsule/24h)
12031456|NCT00355719|Drug|Nevirapine (Viramune)|Nevirapine (Viramune): tablets 200 mg (1 tablet/12h*)
12031457|NCT00355706|Procedure|Thoracic facet joint nerve blocks|Thoracic medial branch blocks
12031458|NCT00355693|Device|Pump for propofol delivery|
12031459|NCT00355680|Device|Green Laser (Aurolas, Aurolab)|Green laser developed by Aurolab
12031460|NCT00355680|Device|Green Laser (Iridex)|Already available green laser
12031461|NCT00355667|Drug|furosemide|Patients with chronic heart failure receive furosemide and other standard treatment/
12031462|NCT00355667|Drug|azosemide|Patients with chronic heart failure receive azosemide and other standard treatment.
12031463|NCT00355654|Biological|DT5aP-IPV-Hib 5-component Pertussis vaccine|0.5 mL, IM
12031464|NCT00355654|Biological|DT3aP-HBs-IPV|0.5 mL, IM
12031465|NCT00355641|Drug|Ropinirole Extended Release (XR)|Dose range of Ropinirole XR of 0.5mg to 6.0mg daily
12031466|NCT00355628|Drug|KW-2246 (fentanyl citrate)|KW-2246
12031467|NCT00355615|Drug|Rosuvastatin|oral
12031468|NCT00355615|Drug|Placebo|oral
12031469|NCT00355602|Drug|Cefuroxime|
12031470|NCT00355602|Drug|Ciprofloxacin|
12031471|NCT00355602|Drug|Clarithromycin|
12031472|NCT00355602|Drug|Cotrimoxazole|
12031473|NCT00355602|Drug|Coamoxiclav|
12031474|NCT00355602|Drug|metronidazole|
12031475|NCT00355602|Drug|neomycin|
12031476|NCT00355602|Drug|rifaximin|
12031477|NCT00355602|Drug|Vancomycin|
12031478|NCT00355602|Drug|Doxycycline|
12031479|NCT00355589|Drug|Ramipril and hydrochlorothiazide|
12031480|NCT00355576|Drug|Celecoxib|Celecoxib 400 mg BID with creatine 10 g BID if randomized to the Celecoxib + Creatine study arm.
12031482|NCT00355576|Drug|Minocycline|Minocycline 100 mg BID with creatine 10 g BID if randomized to the Minocycline + Creatine study arm
12031483|NCT00355563|Device|PAS-Port Automated Proximal Anastomosis System|
12031484|NCT00355550|Drug|Tricaprilin|Powder formulation will be mixed in a liquid (approximately 8 oz).
12031485|NCT00355550|Other|Placebo|Powder formulation will be mixed in a liquid (approximately 8 oz).
12031486|NCT00355537|Drug|Testosterone|Sustanon- intramuscular testosterone 200mg every 2 weeks
12031487|NCT00355537|Drug|0.9% saline|Saline injection intramuscular every 2 weeks
12031488|NCT00355524|Drug|TMC114|TMC114 will be administered as oral tablets (75 milligram [mg] or 300 mg) twice daily at a dose ranging from 300-600 mg up to 48 weeks.
12031489|NCT00355524|Drug|Ritonavir|Ritonavir will be administered as oral capsules (100 mg) or liquid (80 mg/mL) twice daily at a dose ranging from 50 mg (0.625 mL)-100 mg up to 48 weeks.
12031490|NCT00355511|Behavioral|education: disease, medication, self-care, diet|education on heart failure self care; medication initiation and titration, frequent follow-up
12031491|NCT00355485|Device|microdermabrasion|"Device: Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.
~Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart."
12031492|NCT00355472|Drug|KW-0761|IV administration at 4 escalating dose levels.
12031493|NCT00355459|Drug|Tetracycline: Doxycycline analog|
12031494|NCT00355446|Drug|Bimatoprost 0.03%|
12031495|NCT00355433|Procedure|Urodymanics|
12031496|NCT00355407|Drug|Darbepoetin alfa|
12031497|NCT00355394|Drug|Metoclopramide|Intravenous bolus administration.
12031498|NCT00355394|Other|Placebo|Standard care including intravenous fluid, but no metoclopramide.
12031499|NCT00355381|Behavioral|Information Services (IRx)|Information services tailored to the needs of individual patients. The information prescription (IRx)or service is defined for this study as a combination of: 1)An evidence-based web site for use by patients and their families; 2) A reference interview and assistance in locating relevant general information in response to patient information needs; 3) Documentation of the questions and the information service provided in response to these in the patient's Electronic Patient Record for review by providers as needed; and, 4) Triage of patient's/parents clinical questions to providers.
12031500|NCT00355368|Drug|Succinylcholine|1mg/kg iv
12031501|NCT00355368|Drug|Rocuronium|0.6mg/kg iv
12031502|NCT00355355|Drug|Talaporfin sodium|LS11 (Talaporfin Sodium) slowly administered (3-5 min.) in a free flowing intravenous drip at a dose of 1 mg/kg.
12031503|NCT00355355|Device|Interstitial Light Emitting Diodes|200 J/cm per Light Source at 20 mW/cm light energy
12031504|NCT00355355|Procedure|Percutaneous placement of device in the liver|Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions.
12031505|NCT00355355|Procedure|Standard Care|The standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution.
12031506|NCT00355342|Drug|Salmeterol 50 mcg BID|Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
12031507|NCT00355342|Drug|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
12031508|NCT00355342|Device|DISKUS inhaler|Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
12031509|NCT00355329|Procedure|Tongue Acupuncture (Procedure)|
12031510|NCT00355316|Other|Blood draw|
12031511|NCT00355303|Drug|Misoprostol|Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses
12031512|NCT00355303|Drug|PGE2 gel|PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses
12031513|NCT00355290|Behavioral|Changes on Oral Vitamin K Intake|
12031514|NCT00355277|Drug|Amitriptyline|
12031515|NCT00355264|Drug|Phenoptin|5mg/kg/day orally, dose may be adjusted to between 5-20 mg/kg/day by investigator at week 6 to control blood Phe levels
12031516|NCT00355251|Drug|Atorvastatin 40 mg/Atorvastatin 80 mg|Atorvastatin 40 mg/80 mg
12031517|NCT00355238|Drug|brivanib (active)|Tablet, Oral, Brivanib 800 mg, once daily, until progression
12031518|NCT00355225|Procedure|ITN distribution channel|
12031519|NCT00355212|Procedure|percutaneous ablation of hepatocellular carcinoma|
12031520|NCT00355199|Drug|Rituximab-HDS|Rituximab-HDS
12031521|NCT00355199|Drug|Rituximab-CHOP|Rituximab-CHOP
12031522|NCT00355186|Procedure|intracoronary bone marrow cells infusion|"intracoronary bone marrow cell infusion via a OTW balloon; Stop-flow-technique as previously described"
12031523|NCT00355173|Device|Lubo cervical collar|
12031524|NCT00355147|Behavioral|Physician stroke guideline adherence|Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
12031525|NCT00355147|Behavioral|Stroke Self Management|Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA
12031526|NCT00355147|Other|Attention Control Group|Received Phone Calls from Staff to Control for Attention
12031527|NCT00355134|Drug|Fingolimod|Fingolimod capsules for oral administration
12031528|NCT00355134|Drug|Placebo|Matching placebo capsules for oral administration.
12031529|NCT00355121|Biological|Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
12031530|NCT00355121|Biological|Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
12031531|NCT00355121|Biological|Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
12031532|NCT00355108|Drug|tranexamic acid|2 3-month-periods in cross-over: placebo or 3g/day of tranexamic acid
12031533|NCT00355095|Drug|Erythropoietin|intravenous daily 3.3 *10^4 Units, duration 3 days
12031534|NCT00355082|Drug|lamotrigine, 300 mg/day|300 mg/day
12031535|NCT00355082|Drug|lamotrigine, 250 mg/day|250 mg/day
12031536|NCT00355069|Behavioral|electronic (computer based) provider feedback tool|All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
12031537|NCT00355056|Other|Sham Procedure|Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.
12031538|NCT00355056|Device|AMPLATZER PFO Occluder|Patients in this arm will receive the AMPLATZER PFO Occluder device
12031539|NCT00355043|Drug|Zinc sulphate 20 mg|
12031540|NCT00355030|Drug|somatropin|0.05 mg/kg/day
12031541|NCT00355030|Drug|leuprorelin|11.25 mg/3 months
12031542|NCT00355017|Procedure|BNP-guided care in addition to multidisciplinary management|
12031543|NCT00355004|Other|counseling intervention|
12031544|NCT00355004|Procedure|fecal occult blood test|
12031545|NCT00355004|Procedure|screening colonoscopy|
12031546|NCT00354991|Drug|losartan potassium (+) hydrochlorothiazide|Patients took losartan 50 mg /HCTZ 12.5 mg orally once daily for 13 weeks. At Weeks 0, 4 and 8 if the blood pressure goal was not reached then the losartan/HCTZ combination will be titrated upwards according to the following scheme: losartan 50/HCTZ 12.5 to losartan 100/HCTZ 12.5 to losartan 100/HCTZ 25.
12031547|NCT00354978|Drug|5-Fluorouracil|"400 mg/m^2 injection by vein Day 1 of 14 day cycle immediately after completion of leucovorin infusion.
~2.4 g/m^2 by vein over 46 hours over Days 1-3 of 14 day cycle immediately after completion of 400 mg/m^2 injection."
12031548|NCT00354978|Drug|Bevacizumab|"5 mg/kg over 90 minutes on Day 1 of first 14 day cycle as initial dose, administered alone without other drugs.
~5 mg/kg by vein on Day 1 of 14 day cycle."
12031549|NCT00354978|Drug|Leucovorin|400 mg/m^2 over 2-4 minutes by vein on Day 1 of 14 day cycle.
12031550|NCT00354978|Drug|Irinotecan|180 mg/m^2 by vein over 90 minutes on Day 1 of 14 day cycle.
12031551|NCT00354965|Drug|amoxicillin/clavulanate potassium|amoxicillin/clavulanate potassium
12031552|NCT00354952|Drug|Macrolides (azithromycin or clarithromycin)|
12031553|NCT00354939|Drug|Insulin glargine|
12031554|NCT00354926|Biological|AME-133v (LY2469298)|IV 4X weekly X 4
12031555|NCT00354913|Drug|hydroxyurea|Hydroxyurea is administered orally twice a day. The dose will be set at 500 mg twice a day for all patients. If vomiting occurs not additional trial medication should be taken that day in an effort to replace the material that has been vomited. It is recommended that patients take their prescribed hydroxyurea at the same time that they take their prescribed imatinib mesylate, however, a 30-60 minute interval between agents is acceptable, if required for practical or other compliance issues.
12031556|NCT00354913|Drug|imatinib mesylate|"Imatinib administered orally on daily, continuous basis. Imatinib doses of 400mg/600mg administered once daily, whereas daily doses of 800mg/greater administered as equally divided dose taken twice day.
~Dose for Imatinib:
~Patients receiving p450-inducing antiepileptic drugs:500mg twice day Patients not receiving p450-inducing antiepileptic drugs:400mg/day.
~If patients who were not on Cytochrome P450, family 3, subfamily A (CYP3A) enzyme-reducing anti-epileptic drug (EIAED) when originally enrolled must initiate CYP3A enzyme-inducing anti-epileptic drug while on study, study regimen will remain same for minimum of 2 wks before pt transitions to dosing as specified for patients on anti-epileptic drug. If patients originally enrolled must discontinue all EIAEDs while on study, in interest of patient safety, dosing of study regimen will transition to that of patients not on anti-epileptics immediately."
12031557|NCT00354900|Drug|Aprotinin|
12031558|NCT00354887|Drug|Capecitabine|Oral capecitabine 750 mg/m^2 twice daily (total daily dose 1500 mg/m^2) on Days 1-14 in 21 Day Cycle.
12031559|NCT00354887|Drug|Oxaliplatin|130 mg/m^2 by vein Day 1 over 2 hours in 21 Day Cycle
12031560|NCT00354874|Drug|GW642444|drug
12031561|NCT00354874|Drug|Placebo|placebo
12031562|NCT00354874|Drug|salmeterol 50mcg|salmeterol
12031563|NCT00354861|Biological|hepatitis B antigen (without alum) plus IMP321|hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321
12031564|NCT00354861|Biological|hepatitis B antigen alone (without alum)|hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
12031565|NCT00354861|Biological|Engerix B|20 µg hepatitis B antigen absorbed on alum
12031566|NCT00354835|Drug|Irinotecan Hydrochloride|Given IV
12031567|NCT00354835|Biological|Dactinomycin|Given IV
12031568|NCT00354835|Drug|Cyclophosphamide|Given IV
12031569|NCT00354835|Drug|Vincristine Sulfate|Given IV
12031570|NCT00354835|Radiation|Radiation Therapy|Undergo radiotherapy
12031571|NCT00354835|Other|Laboratory Biomarker Analysis|Correlative studies
12031572|NCT00354835|Other|Questionnaire Administration|Ancillary studies
12031573|NCT00354822|Drug|Zevalin|Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline platelet counts>150x10^9/L or 0.3 mCi/kg for patients with baseline platelet counts of 100 to 149x10^9/L. Rituximab 250mg/sqm is given prior to therapeutic radiolabeled antibodies.
12031574|NCT00354809|Drug|GW679769|
12031575|NCT00354770|Drug|Placebo|daily
12031576|NCT00354770|Drug|N-Acetyl Cysteine|600mg capsules in varying doses for 12 weeks.
12031577|NCT00354757|Drug|rabeprazole|
12031578|NCT00354744|Biological|dactinomycin|"Age based dosage: ≥ 1 year 0.045 mg/kg IV x 1(maximum dose 2.5 mg), < 1 year 0.025 mg/kg.
~Day 1 of Weeks 35, 38, 41 and 44.
~Given IV"
12031579|NCT00354744|Drug|cyclophosphamide|"Age based dosage: ≥ 3 years 1200 mg/m2, <3 years 40 mg/kg.
~Day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 and 44.
~Given IV"
12031639|NCT00354419|Radiation|total-body irradiation|Undergo radiotherapy
12031580|NCT00354744|Drug|doxorubicin hydrochloride|"Age based dosage: ≥ 1 year: 37.5mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis. Total dose 75 mg/m².
~Days 1 and 2 of weeks 7, 11, 15, 28 and 32.
~Given IV"
12031581|NCT00354744|Drug|etoposide|"Age based dosage: ≥ 1 year: 100 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.
~Days 1-5 of weeks 9, 13, 17, 26 and 30.
~Given IV"
12031582|NCT00354744|Drug|ifosfamide|"Age based dosage: ≥ 1 year: 1800 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.
~Days 1-5 of weeks 9, 13, 17, 26 and 30.
~Given IV"
12031583|NCT00354744|Drug|irinotecan hydrochloride|"Dosage 50 mg/m2-max dose 100 mg/day.
~Days 1-5 of weeks 1, 4, 20, 23, 47 and 50.
~Given IV"
12031584|NCT00354744|Drug|vincristine sulfate|"Age based dosage: ≥ 3 years 1.5 mg/m2 (max dose 2 mg), ≥ 1 year and < 3 years 0.05 mg/kg (max dose 2 mg), < 1 year 0.025 mg/kg.
~Days 1-5 of weeks 1, 2, 3, 4, 5, 7, 8, 11, 12, 15, 16, 20, 21, 22, 23, 24, 28, 29, 32, 33, 35, 38, 41, 42, 43, 44, 47, 48, 50, and 51.
~Given IV"
12031585|NCT00354744|Procedure|conventional surgery|"Resection of the primary tumor with a surrounding envelope of normal tissue"
12031586|NCT00354744|Radiation|radiation therapy|Radiotherapy beginning at Week 20 to the primary tumor and to the metastatic sites excepting those with parameningeal tumors with intracranial extension (direct extension into the brain) and those requiring emergency radiotherapy
12031587|NCT00354744|Biological|filgrastim|"5 micrograms/kg/day (max 300 micrograms) beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/μL whichever comes last.
~Given subcutaneously."
12031588|NCT00354731|Drug|pentoxifylline|Oral pentoxifylline 1,200 mg/day (for estimated GFR ≧60 ml/min) or 800 mg/day (estimated GFR 59-30 ml/min) x 6 months, followed by stepwise reduction (800 mg/day x 6 M, 400 mg/day x 6 M and discontinued at 18 M
12031589|NCT00354731|Drug|Corticosteroid|Oral prednisolone (1 mg/kg/day) x 3 M, followed by gradual tapering (0.5 mg/kg/day at 6 M, 0.25 mg/day at 12 M, and discontinued at 18 M
12031590|NCT00354705|Behavioral|Questionnaire|Two questionnaires taking 30 minutes to complete.
12031591|NCT00354692|Drug|Sodium Ferric Gluconate and Iron sucrose|
12031592|NCT00354679|Biological|bevacizumab|
12031593|NCT00354679|Drug|cisplatin|
12031594|NCT00354679|Drug|irinotecan hydrochloride|
12031595|NCT00354679|Genetic|proteomic profiling|
12031596|NCT00354679|Other|diagnostic laboratory biomarker analysis|
12031597|NCT00354679|Other|mass spectrometry|
12031598|NCT00354679|Procedure|adjuvant therapy|
12031599|NCT00354679|Procedure|neoadjuvant therapy|
12031600|NCT00354679|Procedure|therapeutic conventional surgery|
12031601|NCT00354679|Radiation|radiation therapy|
12031602|NCT00354666|Drug|GSK159797|
12031603|NCT00354653|Drug|LAMIVUDINE|
12031604|NCT00354640|Drug|anastrozole|1 milligram tablet PO QD for 14 days
12031605|NCT00354640|Drug|simvastatin|40 milligram tablet PO QD for 14 days
12031606|NCT00354640|Other|pharmacological study|laboratory analysis
12031607|NCT00354640|Procedure|adjuvant therapy|laboratory analysis
12031608|NCT00354627|Drug|TMC125|200 mg b.i.d. till commercially available.
12031609|NCT00354614|Device|ApneaLink Sleep Screener|Device used to evaluate for the presence of OSA
12031610|NCT00354601|Drug|capecitabine|oral capecitabine twice daily on days 1-21
12031611|NCT00354601|Drug|docetaxel|docetaxel IV over 30 minutes on days 1, 8, and 15
12031612|NCT00354575|Drug|Chinese Herb: CCH1|1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation
12031613|NCT00354562|Drug|ABT-751|200mg ABT-751 daily for 14 days every 21 days
12031614|NCT00354562|Drug|Placebo|Placebo daily for 14 days every 21 days
12031615|NCT00354562|Drug|Docetaxel|Standard Docetaxel every 21 days
12031616|NCT00354549|Drug|bevacizumab + erlotinib hydrochloride|Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
12031617|NCT00354549|Drug|gemcitabine hydrochloride + cisplatin or carboplatin|Beginning within 3 weeks of documented disease progression, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
12031618|NCT00354536|Drug|GSK716155 subcutaneous injections|albiglutide subcutaneous injection
12031619|NCT00354536|Biological|placebo injection|placebo injection
12031620|NCT00354523|Drug|Capecitabine (Xeloda)|Starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle.
12031621|NCT00354523|Drug|DTIC-Dome (Dacarbazine)|Starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle.
12031622|NCT00354523|Drug|Gleevec (Imatinib Mesylate)|Starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
12031623|NCT00354510|Drug|GW842470X cream|
12031624|NCT00354497|Other|physiologic testing|
12031625|NCT00354497|Other|study of socioeconomic and demographic variables|
12031626|NCT00354497|Procedure|evaluation of cancer risk factors|
12031627|NCT00354497|Procedure|mutation carrier screening|
12031628|NCT00354497|Procedure|study of high risk factors|
12031629|NCT00354484|Drug|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
12031630|NCT00354484|Drug|Ferrous Sulfate tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
12031631|NCT00354471|Procedure|Uterine Artery Embolization|
12031632|NCT00354458|Drug|rolofylline|rolofylline 30 mg IV QD; 3 days
12031633|NCT00354458|Drug|Comparator: Placebo (unspecified)|rolofylline Pbo 30 mg IV QD; 3 days
12031634|NCT00354445|Drug|pegaptanib sodium (Macugen)|
12031635|NCT00354432|Dietary Supplement|oral soy protein/isoflavones powder|Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
12031636|NCT00354432|Drug|Venlafaxine|Patients receive oral venlafaxine 75mg.
12031637|NCT00354432|Dietary Supplement|Placebo Powder|Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
12031638|NCT00354432|Drug|Placebo Pill|Patients receive oral placebo pill.
12031640|NCT00354419|Drug|cyclophosphamide|Given IV
12031641|NCT00354419|Biological|anti-thymocyte globulin|Given IV
12031642|NCT00354419|Drug|cyclosporine|Given IV
12031643|NCT00354419|Procedure|umbilical cord blood transplantation|Undergo transplantation
12031644|NCT00354419|Drug|mycophenolate mofetil|Given IV or orally
12031645|NCT00354419|Procedure|bone marrow aspiration|Correlative study
12031646|NCT00354419|Genetic|DNA analysis|Correlative study
12031647|NCT00354419|Biological|filgrastim|Given IV or SC
12031648|NCT00354406|Drug|abciximab|standard i.v. bolus of abciximab is administered at time of randomization in arm A, and at time of primary angioplasty in arm B.
12031649|NCT00354393|Drug|cisplatin|
12031650|NCT00354393|Drug|methotrexate|
12031651|NCT00354393|Drug|vinorelbine ditartrate|
12031652|NCT00354393|Procedure|adjuvant therapy|
12031653|NCT00354393|Procedure|conventional surgery|
12031654|NCT00354393|Procedure|neoadjuvant therapy|
12031655|NCT00354393|Radiation|3-dimensional conformal radiation therapy|
12031656|NCT00354393|Radiation|intensity-modulated radiation therapy|
12031657|NCT00354380|Drug|Methylene blue|
12031658|NCT00354380|Drug|Artesunate|
12031659|NCT00354380|Drug|Amodiaquine|
12031660|NCT00354367|Drug|Certolizumab pegol|
12031661|NCT00354354|Drug|Combivent|Nebulized Combivent (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered once only to subjects.
12031662|NCT00354341|Drug|Epoetin beta|
12031663|NCT00354315|Behavioral|Continuous medical education (CME)|The intervention will be held over a 6 months period. DECISION+ is a multifaceted intervention program that includes: Interactive workshops (3x180 min), reminders of expected behaviours and feedback.
12031664|NCT00354302|Dietary Supplement|calcium carbonate|
12031665|NCT00354302|Dietary Supplement|calcium citrate|
12031666|NCT00354302|Dietary Supplement|cholecalciferol|
12031667|NCT00354302|Drug|alendronate sodium|
12031668|NCT00354302|Drug|calcium gluconate|
12031669|NCT00354302|Drug|risedronate sodium|
12031670|NCT00354302|Other|laboratory biomarker analysis|
12031671|NCT00354302|Procedure|dual x-ray absorptometry|
12031672|NCT00354276|Drug|cytarabine|
12031673|NCT00354276|Drug|laromustine|
12031674|NCT00354263|Biological|IMP321|This study is a single centre, single blind, placebo (step 1) or reference (step 2) randomised study. Healthy young male volunteers will receive single ascending dose of IMP321 in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.
12031675|NCT00354263|Biological|saline|saline injected alone in step 1 or mixed with Aggripal in step 2
12031676|NCT00354250|Drug|ispinesib|Given IV
12031677|NCT00354237|Other|Conventional antidiabetic treatment|No intensive treatment
12031678|NCT00354237|Other|Intensive insulin treatment|Intensive insulin treatment
12031679|NCT00354224|Drug|capecitabine|
12031680|NCT00354224|Drug|oxaliplatin|
12031681|NCT00354211|Device|minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)|
12031682|NCT00354198|Drug|pentoxifylline|intravenous pentoxifylline (0.33-0.66 mg/kg/h from days 1 to 7) followed by oral pentoxifylline 400-800 mg/day (from days 8-90). The dose of intravenous pentoxifylline will be determined by estimated GFR, patients whose GFRs are 30-59 ml/min/1.73 m2 will be given 0.66 mg/kg/h, and those below 30 ml/min/1.73 m2 will be given 0.33 mg/kg/h. The oral dose of pentoxifylline will also be determined by estimated GFR. Patients whose estimated GFRs are between 30-59 ml/min/1.73 m2 will be given 800 mg/day, and those below 30 ml/min/1.73 m2 will be given 400 mg/day.
12031683|NCT00354198|Drug|corticosteroids|intravenous methylprednisolone (15 mg/kg/day or a maximum of 1 g/day) x 3 days + oral prednisolone (0.5-1.0 mg/kg/day) for 27 days] x 3 courses
12031684|NCT00354185|Drug|tanespimycin|Given IV
12031685|NCT00354185|Drug|belinostat|Given IV
12031686|NCT00354185|Other|laboratory biomarker analysis|Correlative studies
12031687|NCT00354185|Other|pharmacological study|Correlative studies
12031688|NCT00354172|Biological|aldesleukin|10 Million units subcutaneous every other day on days -13 (after Natural killer cell graft), -11, -9, -7, -5, -3) If < 45 kilograms (Kg) - interleukin (IL)-2 at 5 MU/m2
12031689|NCT00354172|Biological|filgrastim|All patients will receive filgrastim (same as granulocyte-colony stimulating factor or G-CSF) 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight beginning on day +1 after umbilical cord blood (UCB) infusion. Granulocyte Colony Stimulating Factor (G-CSF) will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days and then discontinued. If the ANC decreases to <1.0 x 10^9/L, G-CSF will be reinstituted.
12031690|NCT00354172|Biological|natural killer cell (NK) therapy|All CD3 depleted cells will be given (less those required for product monitoring). The minimum size of a starting NK cell unit will be 700 million mononuclear cells before processing. NK cells (CD56+) and NK cell precursors (CD34+/CD7-, CD34+/CD7+, CD34-/CD7+) will be monitored and reported but will not serve as lot release.
12031691|NCT00354172|Drug|cyclophosphamide|Cyclophosphamide to be administered with high volume fluid flush and mesna on days-18 and -17 after fludarabine. Cyclophosphamide 60 mg/kg/day intravenously (IV) x 2 days, total dose 120 mg/m2 (days -18 and -17)
12031692|NCT00354172|Drug|cyclosporine|Patients will receive cyclosporine (CSA) therapy beginning on day -1 maintaining a level of >200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children <40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.
12031693|NCT00354172|Drug|fludarabine phosphate|Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -18 to -16)
12031694|NCT00354172|Drug|methylprednisolone|"This modification will be enacted based on the engraftment stopping rule on all subsequent patients to stop natural killer (NK) cell reaction.
~Methylprednisolone bolus 1000 mg intravenously (IV) will be administered day -1 and day 0 (before umbilical cord blood transplant) to suppress natural killer (NK) cell activity before transplant. Starting cyclosporin and mycophenolate mofetil (MMF) will also contribute to suppressing residual NK cell activity."
12031695|NCT00354172|Drug|mycophenolate mofetil|"All patients will begin mycophenolate mofetil (MMF) on day -1. Patients
~≥ 45 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses. Pediatric patient (<45 kilograms) will receive MMF at the dose of 15 mg/kg. Use intravenous (IV) route between days -1 and +5, then, if tolerated, may change to by mouth (PO) between days +6 and +30.
~Stop MMF at day +30 or 7 days after engraftment, whichever day is later, if no acute Graft Versus Host Disease. (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 x 10^9 /L)."
12031696|NCT00354172|Procedure|Umbilical Cord Blood Transplantation (UCBT)|The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.
12031697|NCT00354172|Radiation|Total body irradiation (TBI)|"TBI 165 Gray (cGy) will be given twice daily for a total dose of 1320 cGy (days
~-16 to -13)."
12031698|NCT00354159|Device|Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)|Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.
12031699|NCT00354146|Drug|tipifarnib (R115777)|
12031700|NCT00354133|Device|Kinetra and Soletra (neurostimulator, Medtronic)|Patients in this arm were implanted with a neurostimulator (Kinetra and Soletra from Medtronic) are stimulated. Additionally the get best medical treatment.
12031701|NCT00354133|Drug|Best Medical Treatment|Patients in this arm get best medical treatment only
12031702|NCT00354120|Drug|Alentuzumab|Alentuzumab
12031703|NCT00354120|Drug|Globulina antilinfocitaria|Globulina antilinfocitaria
12031704|NCT00354107|Biological|monoclonal antibody SGN-30|Given IV
12031705|NCT00354107|Drug|therapeutic hydrocortisone|Given IT
12031706|NCT00354107|Drug|ifosfamide|Given IV
12031707|NCT00354107|Drug|carboplatin|Given IV
12031708|NCT00354107|Drug|etoposide|Given IV
12031709|NCT00354107|Drug|methotrexate|Given IT
12031710|NCT00354107|Drug|cytarabine|Given IT
12031711|NCT00354107|Other|pharmacological study|Correlative studies
12031712|NCT00354107|Other|laboratory biomarker analysis|Correlative studies
12031713|NCT00354094|Drug|[S,S]-Reboxetine|
12031714|NCT00354081|Drug|folic acid, vitamin B12 (cyanocobalamin), vitamin B6 (pyridoxine)|folic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg, in a capsule, taken orally once a day
12031715|NCT00354081|Drug|folic acid, vitamin B12 (cyanocobalamin)|folic acid 0.8 mg plus vitamin B12 0.4 mg, in a capsule, taken orally once a day
12031716|NCT00354081|Drug|vitamin B6 (pyridoxine)|vitamin B6 40 mg, in a capsule, taken orally once a day
12031717|NCT00354081|Drug|placebo|placebo, in a capsule, taken orally once a day
12031718|NCT00354068|Drug|imatinib mesylate|
12031719|NCT00354068|Drug|temozolomide|
12031720|NCT00354068|Other|pharmacological study|
12031721|NCT00354042|Drug|GW597901X|
12031722|NCT00354029|Drug|S (+) Ketamine|0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
12031723|NCT00354029|Drug|Placebo|isotonic saline
12031724|NCT00354016|Biological|preservative free inactivated split influenza vaccine using the strain composition 2006/2007|
12031725|NCT00354003|Behavioral|A series of questionnaires|Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.
12031726|NCT00353990|Drug|Insulin Aspart|
12031727|NCT00353977|Biological|ALVAC-CMV (vCP260)|"ALVAC-pp65 (vCP260), an attenuated canary pox-based vaccine (Aventis Sanofi Pasteur, Lyon, France), 3 doses (1.0 ml each) delivered intramuscularly in the deltoid muscle.
~Sero-negative subjects will receive a total of 3 immunizations to be given day 0, 5 and 10.
~Sero-positive subjects will receive a total of 2 immunizations to be given day 0 and 5. (Protocol amendment after findings from the 9/6/2006 interim analysis demonstrated that in the sero-positive group, only 2 vaccinations were required to generate maximum immune response.)"
12031728|NCT00353964|Drug|rEV131|
12031729|NCT00353964|Drug|Prenisolone sodium phosphate 1.0%|
12031730|NCT00353964|Drug|rEV131 vehicle|
12031731|NCT00353938|Drug|3,4-methylenedioxymethamphetamine 125 mg|Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2-2.5 hours later they receive 62.5 mg MDMA orally.
12031732|NCT00353938|Drug|3,4-methyelendioxymethamphetamine 25 mg|Participants will receive a 25 mg MDMA and if investigator and participant agree, 2 to 2.5 hours later a dose of 12.5 mg MDMA.
12031733|NCT00353938|Behavioral|Psychotherapy|Psychotherapy performed by a team of two co-therapists
12031734|NCT00353912|Drug|valsartan + amlodipine|
12031735|NCT00353886|Procedure|TONI-3|
12031736|NCT00353886|Procedure|WRAT-3|
12031737|NCT00353886|Procedure|Connor's Rating Scales PRS & TRS|
12031738|NCT00353886|Procedure|Peabody Picture Vocabulary Test|
12031739|NCT00353886|Procedure|Children's Memory Scale|
12031740|NCT00353886|Procedure|WISC-3|
12031741|NCT00353886|Procedure|Behavioral Assessment System for Children PRS & TRS|
12031742|NCT00353873|Drug|Fluticasone propionate|200μg twice daily
12031743|NCT00353873|Drug|Fluticasone propionate/salmeterol|50/100μg twice daily
12031744|NCT00353860|Device|SOLEX 300i Stem Cell Selection|
12031745|NCT00353847|Device|Acupuncture|
12031746|NCT00353834|Drug|Exenatide|Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks
12031747|NCT00353834|Drug|Glargine Insulin|Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia.
12031748|NCT00353808|Drug|[S,S]-Reboxetine|
12031749|NCT00353795|Procedure|MR Imaging of the Coronary Arteries|
12031750|NCT00353769|Procedure|Hair Apposition Technique|
12031751|NCT00353756|Drug|C326, IL-6 Inhibitory Avimer protein|
12031752|NCT00353743|Drug|placebo|placebo
12031753|NCT00353743|Drug|doxycycline plus metronidazole|doxycycline 200mg/day plus metronidazole 500mg/day up to 10 days of treatment (additional to the hospital treatment)
12031754|NCT00353717|Drug|cetuximab paclitaxel|weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2
12031755|NCT00353704|Drug|pregabalin|capsule 150 mg x 1 per orally one hour before surgery
12031756|NCT00353704|Drug|Placebo|One capsule of saccharose (placebo) was administered about one hour before surgery
12031757|NCT00353704|Drug|morphine|All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).
12031758|NCT00353691|Drug|glimepiride|
12031759|NCT00353691|Drug|metformin|
12031760|NCT00353678|Drug|YM150|
12031761|NCT00353665|Drug|Memantine (Ebixa)|10 mg bid
12031762|NCT00353665|Drug|riluzole|riluzole 50 mg bid
12031763|NCT00353665|Drug|Placebo|
12031764|NCT00353652|Drug|Study#1: chlorthalidone (CTD), titrated dose|Participants in study #1 will receive 3 months of chlorthalidone (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg
12031765|NCT00353652|Drug|Study #1: spironolactone (SP), titrated dose|Participants in study #1 will receive 3 months spironolactone (25-75 mg/d), at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg.
12031766|NCT00353652|Drug|Study# 2 chlorthalidone (CTD), fixed dose|Participants in study #2 will receive 3 months of fixed-dose of CTD, at 25 mg/d.
12031767|NCT00353652|Drug|Study# 2 spironolactone (SP), fixed dose|Participants in study #2 will receive 3 months of fixed-dose SP at 25 mg daily.
12031768|NCT00353652|Drug|Study# 2 irbsesartan (IR), fixed dose|Participants in study #2 will receive 3 months of fixed-dose IR at150 mg daily.
12031769|NCT00353613|Behavioral|Package of targeted interventions to reduce error|Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.
12031770|NCT00353587|Drug|MBX-102|MBX-102 200 mg once daily for 16 weeks
12031771|NCT00353587|Drug|MBX-102|MBX-102 400 mg once daily for 16 weeks
12031772|NCT00353587|Drug|MBX-102|MBX-102 600 mg once daily for 16 weeks
12031773|NCT00353587|Drug|Placebo|MBX-102 Placebo once daily for 16 weeks
12031774|NCT00353587|Drug|Actos|Actos 30 mg once daily for 16 weeks
12031775|NCT00353574|Drug|Darusentan|Darusentan capsules administered orally once daily
12031776|NCT00353561|Drug|Boric|Gelatin capsules filled with 600 mg of boric acid
12031777|NCT00353561|Drug|Fluconazole|150 mg oral fluconazole gives once in 14 days
12031778|NCT00353535|Procedure|Total Lymphoid irradiation|
12031779|NCT00353522|Drug|Placebo|po daily for 24 weeks
12031780|NCT00353522|Drug|dalcetrapib|900mg po daily for 24 weeks
12031781|NCT00353509|Device|Device Closure of a Septal Defect|
12031782|NCT00353496|Drug|lanreotide (Autogel formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
12031783|NCT00353496|Drug|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
12031784|NCT00353483|Procedure|Peripheral blood draw|
12031785|NCT00353483|Procedure|Breast tissue collection|
12031786|NCT00353483|Procedure|Bone marrow biopsy|
12031787|NCT00353470|Behavioral|Cognitive behavioral therapy|CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
12031788|NCT00353470|Behavioral|Applied relaxation training (ART)|ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
12031789|NCT00353470|Behavioral|Panic focused psychodynamic psychotherapy (PFPP)|PFPP will include 19 to 24 sessions over 12 weeks.
12031790|NCT00353457|Drug|Capecitabine, Oxaliplatin and Cetuximab|Capecitabine 825mg/m2 po BID D1-15 of 21 x2 cycles (Cyle 1 and 2), Capecitabine 825mg/m2 po BID weekly Sun PM-Fri AM x2 cycles (cycle 3 and 4), Capecitabine 825mg/m2 po BID D1-15 of 21 x4 cycles (cycle 5,6,7,8) Oxaliplatin 130mg/m2 IV Day 1 every 3 weeks x2 cycles (Cycle 1 and 2), Oxaliplatin 50mg/m2 IV weekly every Monday x2 cycles (Cycle 3 and 4), Oxaliplatin 130mg/m2 IV day 1 every 3 weeks x4 cycles (Cycles 5,6,7,8) Cetuximab 400mg/m2 IV cycle 1 day1, Cetuximab 250mg/m2 Day 1,8,15 of 21 for cycles 1-8
12031791|NCT00353457|Radiation|Radiation|45 Gy in 25 fractions, 3-fraction boost 5.4 Gy
12031792|NCT00353431|Drug|Novorapid ®, Novo Nordisk, Denmark|Comparison of a sliding scale with an intensive s.c. scale
12031793|NCT00353418|Drug|Peginterferon alfa-2a|180 µg subcutaneously weekly for 48 weeks
12031794|NCT00353418|Drug|Ribavirin|800 mg orally daily for 48 weeks
12031795|NCT00353418|Drug|Ribavirin|1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks
12031796|NCT00353405|Behavioral|Social Skills Training|Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.
12031797|NCT00353405|Behavioral|Mass media|Mass media provides messages that support sexual health skills.
12031798|NCT00353405|Behavioral|Control|Control group received no social skills training and no media mass media messages.
12031799|NCT00353392|Device|Laser Therapy|
12031800|NCT00353379|Drug|Guanfacine|Participants will take guanfacine for 6 weeks. Guanfacine dosages will not exceed 2 mg per day.
12031801|NCT00353379|Drug|Placebo|Participants will take placebo for 6 weeks.
12031802|NCT00353366|Biological|Rotarix|Two doses of the oral vaccine
12031803|NCT00353366|Other|Data collection|Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.
12031804|NCT00353353|Procedure|consumption of fortified bread|
12031805|NCT00353340|Drug|n acetylcysteine|
12031806|NCT00353340|Drug|sodium bicarbonate|
12031807|NCT00353340|Drug|sodium chloride|
12031808|NCT00353327|Procedure|Plasma infusion|
12031809|NCT00353301|Drug|Erlotinib hydrochloride|Patients will receive single-agent Tarceva, 150 mg/day
12031810|NCT00353301|Drug|Sirolimus|Patients will receive a loading dose of 6 mg of Rapamune seven days after beginning treatment with Tarceva™ followed by a dose of 2mg/day.
12031811|NCT00353288|Biological|MeMuRu-OKA (study vacc)|
12031812|NCT00353288|Biological|MMR, Varicella vacc (control)|
12031813|NCT00353275|Drug|Strict Glycemic control|Blood glucose target range is 80-110 mg/dL.
12031814|NCT00353275|Drug|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
12031815|NCT00353262|Drug|Avastin|7.5mg/kg iv (cycle 3 only)
12031816|NCT00353262|Drug|Oxaliplatin|130mg/m2 iv (cycles 1, 2 and 3)
12031817|NCT00353262|Drug|capecitabine [Xeloda]|1000mg/m2 po bid (cycles 1, 2 and 3)
12031818|NCT00353249|Behavioral|Adapted cognitive behavioral therapy (CBT)|Adapted CBT is a group treatment for PTSD and will occur two times per week for 4 weeks. The sessions will last 90-minutes and will be led by a therapist and co-therapist.
12031819|NCT00353223|Behavioral|Interpersonal and behavioral psychotherapy|Participants will receive a combined intervention of interpersonal and behavioral psychotherapy designed for people with heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours. The psychotherapy sessions will allow participants to discuss how they are coping with their illness and loss of functioning. They will also aim to help participants with heart failure to develop new recreational activities in keeping with their new level of functioning.
12031820|NCT00353223|Behavioral|Attention control (AC) condition|The AC group will not receive therapy. Instead, a clinician will ask them questions about their depression and heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours.
12031821|NCT00353184|Drug|Montelukast 5-mg orally added to standard therapy|
12031822|NCT00353158|Drug|Doxycycline|100mg twice daily for 3 days. Two hours after the last dose of doxycycline is taken in the clinic, on-medication phototesting with ssUVR, UVA, and visible light will be performed.
12031823|NCT00353158|Drug|Voriconazole|After taking voriconazole for (Bullet)7 days to achieve a steady state of voriconazole for subjects, on-medication phototesting with ssUVR, UVA, and visible light will be performed.
12031824|NCT00353145|Drug|Gemcitabine (Gemox)|1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 repeated every 14 days (one cycle).
12031825|NCT00353145|Drug|Oxaliplatin|100 mg/m^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).
12031826|NCT00353145|Behavioral|Questionnaire|Quality of Life Surveys
12031827|NCT00353119|Drug|Placebo comparator|Patients received placebo subcutaneously twice weekly
12031828|NCT00353119|Drug|Etanercept|Patients received etanercept 50 mg subcutaneously twice weekly
12031829|NCT00353106|Behavioral|Interview|30-minute interviews of participating patients and their caregiver(s).
12031830|NCT00353106|Behavioral|Questionnaire|Questionnaires that will take approximately 5 minutes to complete.
12031831|NCT00353093|Procedure|Ultrasonography of the deep vein system of the legs|
12031832|NCT00353080|Drug|risedronate (HMR4003)|
12031833|NCT00353067|Drug|veliflapon (DG-031)|
12031834|NCT00353054|Drug|Caltrate® 600 + D|
12031835|NCT00353054|Behavioral|Weight loss intervention|
12031836|NCT00353041|Drug|lidocaine topical|
12031837|NCT00353028|Drug|Fluvoxamine maleate|Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica
12031838|NCT00353028|Drug|Placebo|Placebo
12031839|NCT00353015|Drug|Cisplatin|Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle
12031840|NCT00353015|Drug|Irinotecan|Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle
12031841|NCT00353002|Drug|Ametop (4% Amethocaine cream )|
12031842|NCT00353002|Drug|Maxilene (4% Liposomal Lidocaine)|
12031843|NCT00352989|Drug|Smecta (Diosmectite), duration of treatment - 7 days|
12031844|NCT00352976|Drug|Cyclophosphamide|Day -5 through Day -2, subjects will receive chemotherapy of Cyclophosphamide via central line (i.e. Hickman or Broviac),10 mg/kg intravenously (IV)
12031845|NCT00352976|Drug|Fludarabine|Day -5 through Day -2 prior to transplant; subjects will receive chemotherapy of Fludarabine via central line (i.e. Hickman or Broviac),35 mg/m^2 intravenous (IV)
12031846|NCT00352976|Procedure|Total Body Irradiation|total body irradiation (300 cGy) with thymic shielding will be given six days before the stem cells are given (day -6). Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus.
12031847|NCT00352976|Procedure|Bone Marrow Transplantation|A target of 5 * 10^6/kg and a minimum of 4 * 10^6 CD34+ cell/kg recipient weight will be collected by apheresis and used for transplant. In most cases this dose will be recovered in a single apheresis; however, a second or rarely third apheresis performed on the following days may be required to achieve the minimum dose.
12031848|NCT00352976|Drug|Mycophenolate Mofetil|Patients will receive MMF therapy beginning on day -3 through day +30 or for 7 days after engraftment, whichever day is later, if no acute graft-versus-host disease (GVHD). Engraftment is defined as 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 * 10^9/L. MMF will be given at a dose of 15 mg/kg/dose every 8 hours by mouth(to a maximum dose of 1 gram).
12031849|NCT00352976|Drug|Sirolimus|Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC). Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
12031850|NCT00352963|Biological|Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec|
12031851|NCT00352950|Drug|AMG 954/Panitumumab|
12031852|NCT00352911|Drug|VGX-410 (Mifepristone)|
12031853|NCT00352911|Drug|Placebo for VGX-410 (Mifepristone)|
12031854|NCT00352898|Biological|MeMuRu-OKA (study vac)|
12031855|NCT00352898|Biological|MMR, Varicella vacc (control)|
12031856|NCT00352885|Drug|Escitalopram|Participants will begin medication approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 10 mg per day. If 10 mg is well tolerated by the participant, the dosage will be increased to 20 mg per day. The dosage for the remainder of the study will be 20 mg per day.
12031982|NCT00351988|Behavioral|Phenomenological Interviews|Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
12031857|NCT00352885|Drug|Placebo|Participants will begin the placebo approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 1 pill per day, if 1 pill is well tolerated by the participant the dosage will be increased to 2 pills per day. Two pills per day will be the dosage for the reminder of the study.
12031858|NCT00352885|Drug|IL-2|IL-2 is a 12-week treatment regimen with intravenous (IV) IL-2. There will be one cycle every 3 weeks for a total of four cycles. One cycle is 720,000 units/kg every 8 hours for 5 days.
12031859|NCT00352859|Drug|Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon|Continue sorafenib with addition of gemcitabine or interferon
12031860|NCT00352859|Drug|Gemcitabine or Interferon (only)|Discontinue Sorafenib and receive Gemcitabine or Interferon only
12031861|NCT00352846|Drug|Zoledronic Acid|4 mg/m^2 by vein over 30 Minutes at baseline and 6 months.
12031862|NCT00352846|Drug|Vitamin D|400 mg by mouth daily
12031863|NCT00352846|Drug|Calcium Carbonate|1200 mg by mouth daily
12031864|NCT00352833|Drug|catumaxomab|
12031865|NCT00352820|Behavioral|Interview|Recorded face-to-face session.
12031866|NCT00352820|Behavioral|Questionnaire|Written survey lasting approximately 30 minutes.
12031867|NCT00352807|Drug|Brimonidine Purite|
12031868|NCT00352794|Drug|Lenalidomide|Oral 10 mg daily/days 1-21 of 28 day cycle
12031869|NCT00352794|Drug|Prednisone|Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
12031870|NCT00352781|Drug|nicotine replacement therapy|nicotine transdermal patches as per product monograph
12031871|NCT00352781|Behavioral|behavioural intervention|Smoking cessation counselling and relapse prevention
12031872|NCT00352768|Drug|Fluvoxamine maleate|Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica
12031873|NCT00352768|Drug|Placebo|Placebo
12031874|NCT00352755|Procedure|Surgical debulking with peritonectomy|
12031875|NCT00352755|Drug|Intraperitoneal 5FU|
12031876|NCT00352755|Drug|FOLFOX|
12031877|NCT00352742|Drug|ATN-224 + bortezomib|ATN-224 and bortezomib dose to be determined in Phase I portion of study
12031878|NCT00352729|Device|ACell dressing|dressing
12031879|NCT00352716|Drug|Smecta (Diosmectite), duration of treatment - 7 days|
12031880|NCT00352703|Drug|Kepivance (Palifermin)|
12031881|NCT00352690|Drug|Paclitaxel poliglumex|
12031882|NCT00352690|Drug|Carboplatin|
12031883|NCT00352690|Radiation|External beam radiation therapy|
12031884|NCT00352677|Drug|INNO-406|Oral, twice daily self-administration of 10 mg and/or 50 mg tablets
12031885|NCT00352664|Drug|Donepezil|5 mg once a day by mouth for 7 day cycle. After evaluation on Day 8, all participants will be offered donepezil every day for 7 days.
12031886|NCT00352664|Drug|Placebo|Placebo tablet once a day by mouth for one 7 day cycle. After evaluation on day 8, all participants offered donepezil every day for 7 days.
12031887|NCT00352651|Drug|Pregabalin|
12031888|NCT00352638|Other|counseling intervention|
12031889|NCT00352638|Other|educational intervention|
12031890|NCT00352638|Other|study of socioeconomic and demographic variables|
12031891|NCT00352625|Drug|Ketoprofen Topical Patch 20%|
12031892|NCT00352612|Drug|clindamycin|clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days
12031893|NCT00352612|Drug|cephalexin|cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
12031894|NCT00352599|Drug|Lovastatin|
12031895|NCT00352599|Drug|Lovastatin|Lovastatin capsules daily for 14 weeks (titrated up from 10 mg to 40 mg)
12031896|NCT00352599|Drug|placebo pill|
12031897|NCT00352560|Drug|Irbesartan|Tablets, Oral, 300 mg, once daily, 30 days.
12031898|NCT00352560|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 30 days.
12031899|NCT00352534|Procedure|therapeutic conventional surgery|Undergo surgery
12031900|NCT00352534|Drug|vincristine sulfate|Given IV
12031901|NCT00352534|Biological|dactinomycin|Given IV
12031902|NCT00352534|Drug|doxorubicin hydrochloride|Given IV
12031903|NCT00352534|Radiation|3-dimensional conformal radiation therapy|Patients undergo radiotherapy
12031904|NCT00352521|Drug|bevacizumab|
12031905|NCT00352521|Drug|irinotecan|
12031906|NCT00352521|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
12031907|NCT00352508|Behavioral|Dietary advice|
12031908|NCT00352495|Drug|carboplatin|
12031909|NCT00352495|Drug|vinblastine sulfate|
12031910|NCT00352482|Drug|Sildenafil (50 mg)|
12031911|NCT00352469|Drug|Seroquel XR|Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg
12031912|NCT00352443|Drug|everolimus|part 1: dose assigned by ETx online system PO days 1-28 daily part 2: cohort a: 5 mg PO days 1-28 part 2: cohort a: 1250 mg PO days 8-28 (cycle 1) days 1-28 (subsequent cycles)
12031913|NCT00352443|Drug|lapatinib ditosylate|dose assigned by ETx online system PO days 1-28 daily part 2 cohort a: 1250 mg PO d 8-28 (cycle 1) days 1-28 (subsequent cycles) part 2 cohort b: 120 mg PO days 1-28 daily
12031914|NCT00352430|Drug|Nitric Oxide/INP Pulse Delivery|
12031915|NCT00352430|Drug|Nitric Oxide/INO Pulse Delivery|
12031916|NCT00352417|Drug|VIA-2291|100 mg, oral dosing, 1 time daily for 12 weeks
12031917|NCT00352417|Drug|Placebo|oral dosing, 1 time daily for 12 weeks
12031918|NCT00352404|Device|Endomicroscope|
12031919|NCT00352391|Other|Assessments|At Months 6, 12, 18, 24, 30, and 36, complete medical history will be recorded, and a physical exam will be performed by either a doctor or a nurse. At each of these visits, blood will be drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Also, a chest x-ray and a chest CT will be done at these visits.
12031983|NCT00351988|Behavioral|Quantitative Interviews|Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
12031984|NCT00351975|Drug|Belinostat|Given IV
12031985|NCT00351975|Drug|Azacitidine|Given SC
12031920|NCT00352378|Drug|Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine|"Patients will be randomized to receive regimen A (AC) and regimen B(TX),preoperatively as follows:
~Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14"
12031921|NCT00352365|Drug|lenalidomide|Given orally
12031922|NCT00352352|Procedure|Tongue Acupuncture (Procedure)|
12031923|NCT00352339|Drug|Rispridoen and Aripiprazole|Start with risperidone and switch it to aripiprazole. Flexible dose
12031924|NCT00352339|Drug|Risperidne|Start with risperidne and keep it through the end of study. Risperidne:flexible dose
12031925|NCT00352339|Drug|Abilify|Start with abilify and keep it through the end of study
12031926|NCT00352326|Device|reprogramming assisted communication device interface|The subjects were required to touch targets on the iPad® screen with the index finger of their preferred (less-affected) arm. The experimental task consisted of 180 targets divided in 4 blocks: 45 targets each block with a 1-minute interval between trials to avoid fatigue. Targets appeared at 1 of 9 different locations on the screen, and subjects moved their finger sequentially from one target to the next.
12031927|NCT00352313|Drug|ATN-161|Given IV
12031928|NCT00352313|Drug|carboplatin|Given IV
12031929|NCT00352300|Procedure|Adjuvant Therapy|
12031930|NCT00352300|Drug|Carboplatin|Given IV
12031931|NCT00352300|Drug|Paclitaxel|Given IV
12031932|NCT00352300|Biological|Pegfilgrastim|Given IV
12031933|NCT00352287|Drug|Recombinant human growth hormone; pioglitazone|
12031934|NCT00352261|Drug|Esomeprazole|
12031935|NCT00352261|Drug|Lansoprazole|
12031936|NCT00352248|Procedure|Tongue Acupuncture (Procedure)|
12031937|NCT00352235|Drug|KRN7000|
12031938|NCT00352222|Device|stent implantation|
12031939|NCT00352196|Drug|Risperidone|12 weeks of treatment with risperidone 0.25 to 11 mg per day.
12031940|NCT00352196|Other|Magnetic Resonance Spectroscopy|Subjects will receive a standard MRS to assess the concentrations and ratios of brain metabolites N-acetylaspartate, creatine, phosphocreatine, and choline.
12031941|NCT00352183|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 40mg
12031942|NCT00352183|Drug|Simvastatin|Simvastatin 40mg
12031943|NCT00352170|Dietary Supplement|calcium supplementation|calcium carbonate 1500 mg/day
12031944|NCT00352170|Dietary Supplement|calcium and vitamin D3 supplementation|calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
12031945|NCT00352170|Dietary Supplement|Placebo|calcium and vitamin D3 placebo
12031946|NCT00352157|Behavioral|Revival Soy Dietary Supplement|
12031947|NCT00352144|Drug|Eszopiclone|Eszopiclone 3 mg
12031948|NCT00352144|Drug|Placebo|Placebo tablet
12031949|NCT00352131|Drug|HuC242-DM4|Dose escalation study to define maximum tolerated dose. Doses will vary per cohort. Patients will receive an IV infusion once every three weeks.
12031950|NCT00352118|Biological|filgrastim|subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
12031951|NCT00352118|Biological|pegfilgrastim|If applicable on day 5, repeating every 3 weeks for 2 courses.
12031952|NCT00352118|Drug|cisplatin|Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
12031953|NCT00352118|Drug|docetaxel|Intravenous over 1 hour on day 1.
12031954|NCT00352118|Drug|fluorouracil|Intravenous continuously on days 1-4.
12031955|NCT00352118|Procedure|conventional surgery|As appropriate, neck dissection.
12031956|NCT00352118|Radiation|radiation therapy|60 Gy 5 days/week x 6 weeks with cisplatin
12031957|NCT00352105|Drug|cisplatin|20mg/m2/d IV continuous infusion x4 days
12031958|NCT00352105|Drug|fluorouracil|1000mg.m2/d IV continuous x 4 days
12031959|NCT00352105|Drug|Iressa|250mg/PO qd x 2 years
12031960|NCT00352105|Radiation|hyperfractionated radiation therapy|120cGy bid
12031961|NCT00352092|Drug|calcineurin inhibitor|
12031962|NCT00352092|Drug|sirolimus|
12031963|NCT00352092|Drug|mycophenolate mofetil|
12031964|NCT00352079|Biological|BCG vaccine|"Intravesical BCG:
~Induction:
~q weekly x 6 (cycle 1)
~Maintenance:
~q weekly x 3 at 3, 6, 12, 18, 24, 30, 36 months post- 2 randomization (cycles 2 - 8)"
12031965|NCT00352079|Drug|gefitinib|Iressa® 250 mg PO Daily for 12 weeks starting on day 1 of each cycle of intravesical BCG therapy (cycles 1 - 8)
12031966|NCT00352079|Procedure|quality-of-life assessment|Each cycle and at 3 and 6 months after treatment discontinuation
12031967|NCT00352066|Drug|apricitabine|
12031968|NCT00352053|Drug|Tenofovir DF|Tenofovir DF 300-mg tablet, administered orally, daily + OBR
12031969|NCT00352053|Drug|Placebo|Tenofovir DF Placebo administered orally, daily + OBR
12031970|NCT00352027|Drug|Adriamycin®|Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.
12031971|NCT00352027|Drug|Vinblastine|Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.
12031972|NCT00352027|Drug|Nitrogen Mustard|Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.
12031973|NCT00352027|Drug|Cyclophosphamide|May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.
12031974|NCT00352027|Drug|Vincristine|Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
12031975|NCT00352027|Drug|Bleomycin|Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
12031976|NCT00352027|Drug|Etoposide|Given IV on Days 1 and 2 of weeks 1-10.
12031977|NCT00352027|Drug|Prednisone|Given PO every other day of weeks 1-12.
12031978|NCT00352027|Biological|G-CSF|Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).
12031979|NCT00352027|Procedure|Radiotherapy|Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.
12031980|NCT00352001|Drug|azacitidine|Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
12031981|NCT00352001|Drug|lenalidomide|Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
12031986|NCT00351975|Other|Laboratory Biomarker Analysis|Correlative studies
12031987|NCT00351962|Procedure|Fractionated Stereotactic Radiotherapy|
12031988|NCT00351949|Biological|IMP321|subcutaneous injections of IMP321 every 14 days for three months (6 injections. Doses tested: 50, 250, 1,250, 6,250 or 30,000 µg
12031989|NCT00351936|Drug|Aripiprazole|
12031990|NCT00351936|Drug|placebo|
12031991|NCT00351923|Biological|MeMuRu-OKA (study vaccine)|
12031992|NCT00351910|Drug|Quetiapine|
12031993|NCT00351910|Drug|Amitriptyline|
12031994|NCT00351910|Drug|Bupropion|
12031995|NCT00351910|Drug|Citalopram|
12031996|NCT00351910|Drug|Duloxetine|
12031997|NCT00351910|Drug|Escitalopram|
12031998|NCT00351910|Drug|Fluoxetine|
12031999|NCT00351910|Drug|Paroxetine|
12032000|NCT00351910|Drug|Sertraline|
12032001|NCT00351910|Drug|Venlafaxine|
12032002|NCT00351897|Device|pulsed dye (585nm) laser therapy|
12032003|NCT00351884|Drug|Vildagliptin AM|
12032004|NCT00351884|Drug|vildagliptin pm|
12032005|NCT00351884|Drug|placebo|
12032006|NCT00351871|Drug|PEG-Intron Plus REBETOL|
12032007|NCT00351858|Drug|ertumaxomab|
12032008|NCT00351845|Behavioral|Low carbohydrate diet (behavior)|
12032009|NCT00351832|Drug|Vildagliptin|
12032010|NCT00351819|Drug|AndroGel|5g gel, applied once daily to the upper arms, upper back or shoulders.
12032011|NCT00351819|Other|Placebo|5g gel, applied once daily to the upper arms, upper back or shoulders.
12032012|NCT00351806|Drug|Erigeron breviscapus injection|
12032013|NCT00351806|Drug|hua tuo zai zao wan (a herbal medicine pill)|
12032014|NCT00351806|Drug|Compound stroke herbal medicine (8 herbal)|
12032015|NCT00351793|Device|Knee Implant|Total knee replacement with Genesis II posterior stabilized knee
12032016|NCT00351780|Device|FFR measurement, side branch angioplasty|
12032017|NCT00351767|Drug|placebo|Topically applied
12032018|NCT00351767|Drug|telbermin|Topically applied
12032019|NCT00351754|Drug|Isovue|
12032020|NCT00351741|Device|Ventilation - High Frequency Percussive Ventilation|Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
12032021|NCT00351741|Device|Ventilation - ARDSnet|Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)
12032022|NCT00351715|Drug|Sublingual Methadone|
12032023|NCT00351702|Drug|Isoniazid with Ethambutol|Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months
12032024|NCT00351689|Behavioral|dietary supplement|
12032025|NCT00351676|Behavioral|Integration of a team based clinical pharmacist|
12032026|NCT00351676|Drug|Optimizing therapeutic treatments|
12032027|NCT00351676|Behavioral|Optimizing processes of care|
12032028|NCT00351663|Drug|Enoxaparine|"Patients considered eligible will be divided into 2 groups- those receiving vasopressor support and those not receiving vasopressor support at the time of inclusion. The patients in each group will be randomized to receive enoxaparin in accordance with one of the following DVT prophylaxis protocols:
~Intravenous Enoxaparine according to their weight (0.5mg/kg x 1/day)
~Subcutaneous Enoxaparine according to their weight (0.5mg/kg x 1/day)
~Subcutaneous Enoxaparine 40mg x1/day"
12032029|NCT00351637|Drug|Sublingual Methadone|
12032030|NCT00351624|Behavioral|DHA|
12032031|NCT00351624|Behavioral|placebo|
12032032|NCT00351611|Drug|Lyrica (pregabalin)|150 mg twice a day, oral administration
12032033|NCT00351611|Drug|placebo|Twice a day, oral administration
12032034|NCT00351598|Radiation|Definitive Radiotherapy|60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.
12032035|NCT00351585|Drug|Vildagliptin|
12032036|NCT00351572|Procedure|Cell Search Assay|
12032037|NCT00351559|Device|AlloMap molecular expression testing|
12032038|NCT00351559|Procedure|Right ventricular endomyocardial biopsy|
12032039|NCT00351546|Drug|Vildagliptin|
12032040|NCT00351533|Drug|Fish oil (eicosapentaenoic acid and docosahexanoic acid)|Liquid fish oil 7.5cc enterally every 6 hours
12032041|NCT00351520|Drug|Miltefose|
12032042|NCT00351507|Drug|Vildagliptin|
12032043|NCT00351494|Procedure|contrast enhanced ultrasonography|"Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months.
~Abdominal route 2.4 ml sonovue per injection / bolus"
12032044|NCT00351494|Procedure|embolization|Intervention is described in the case report form for each patient
12032045|NCT00351468|Drug|eltrombopag olamine (SB-497115-GR)|Eltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L.
12032046|NCT00351455|Behavioral|smoking cessation|
12032047|NCT00351455|Behavioral|tighter diabetic control|
12032048|NCT00351455|Behavioral|diet and exercise program|
12032049|NCT00351429|Device|Polyglycolic acid suture|PGA suture used in Trabeculectomy surgery
12032050|NCT00351416|Drug|Letrozole|Letrozole 20 mg orally one time
12032051|NCT00351416|Drug|NAL-GLU GnRH antagonist|5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
12032052|NCT00351403|Drug|Ribavirin|Rebetol 200 mg: applied as hard capsule
12032053|NCT00351403|Drug|Peginterferon alfa 2b|PegIntron (50/80/100/120/150 microgram): applied by injection
12032054|NCT00351390|Other|Drug therapy for HF|Titration of HF meds in an aggressive out patient manner following guideline direction
12032055|NCT00351390|Other|NT-proBNP guided HF therapy|Standard of care drug therapy following guideline direction, plus adjustment of medication titrated to achieve NT-proBNP <1000 pg/mL
12032056|NCT00351377|Drug|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.
12032057|NCT00351364|Drug|Montelukast Sodium|100 mg P.O. One time only
12032058|NCT00351351|Device|Cyberwand|FDA approved - dual probe intracorporeal lithotrite
12032059|NCT00351351|Device|single probe ultrasonic|FDA-approved - single probe ultrasonic
12032060|NCT00351325|Drug|BMS-663513|mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks
12032062|NCT00351299|Drug|Dexmedetomidine|dexmedetomidine infusion titrated to effect
12032063|NCT00351299|Other|Standard of Care|Standard of care per treating physician preference
12032064|NCT00351286|Drug|L-citrulline tablets, 1000 mg|
12032065|NCT00351286|Drug|Placebo tablets matching L-citrulline tablets|
12032066|NCT00351286|Drug|Background simvastatin at a stable dose of 40 mg qHS|
12032067|NCT00351273|Drug|Doxycycline and Rifampin|doxycycline 100mg daily; rifampin 300mg daily (both for 6 months)
12032068|NCT00351273|Drug|Azithromycin and Rifampin|Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months)
12032069|NCT00351273|Drug|Placebo|Methylcellulose
12032070|NCT00351260|Procedure|Coronary Angioplasty|
12032071|NCT00351247|Procedure|Postconditioning|
12032072|NCT00351234|Drug|Carnitine (drug)|Oral L-carnitine will be obtained from Sigma Tau Pharmaceuticals. Supplementation will be initiated at 50mg/kg body weight and increased to 100mg/kg body weight after one week.
12032073|NCT00351221|Drug|rhIGF-1/rhIGFBP-3|
12032074|NCT00351208|Device|Medtronic Manufactured Spinal Cord Stimulators|
12032075|NCT00351195|Drug|Etoposide|
12032076|NCT00351195|Drug|Oxaliplatin|
12032077|NCT00351195|Drug|Capecitabine|
12032078|NCT00351182|Drug|Telithromycin|
12032079|NCT00351182|Drug|Doxycycline|
12032080|NCT00351169|Drug|Quetiapine SR|
12032081|NCT00351169|Drug|Escitalopram|
12032082|NCT00351156|Procedure|Blood sample|
12032083|NCT00351143|Drug|salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training|Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.
12032084|NCT00351143|Drug|salmeterol/fluticasone propionate 50/250 µg|Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2
12032085|NCT00351130|Drug|valsartan|
12032086|NCT00351130|Drug|amlodipine|
12032087|NCT00351117|Drug|St. John's Wort|SJW in capsule form 300 mg PO TID
12032088|NCT00351117|Drug|Lactose|lactose in gelatin capsule that same as St. John's wort
12032089|NCT00351104|Drug|Ketoprofen Topical Patch 20%|
12032090|NCT00351091|Drug|RISEDRONATE|
12032091|NCT00351078|Drug|PTC124|4-,4-, and 8-mg/kg PO first 14 days 10-, 10-, and 20-mg/kg TID second 14 days
12032092|NCT00351065|Drug|SK3530|
12032093|NCT00351052|Drug|Pimecrolimus|Pimecroliums cream 1 % bid.
12032094|NCT00351052|Drug|Placebo|Vehicle control (placebo) bid.
12032095|NCT00351039|Drug|Bevacizumab|Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days.
12032096|NCT00351039|Drug|Erlotinib|Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days.
12032097|NCT00351039|Drug|Pemetrexed|Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.
12032098|NCT00351026|Drug|Methadone|short-term methadone maintenance
12032099|NCT00351013|Other|Malaria Tropica Nosode D200|5 pellets every four months
12032100|NCT00351000|Drug|Ziprasidone|
12032101|NCT00350987|Behavioral|a strategy based on PCT guided AB therapy|In this study a strategy based on PCT guided AB therapy with enforced guideline implementation will be compared.
12032102|NCT00350961|Drug|Gemcitabine|
12032103|NCT00350961|Drug|Oxaliplatin|
12032104|NCT00350961|Drug|Capecitabine|
12032105|NCT00350948|Drug|Telcyta|Day 1 of 28 day Cycle.
12032106|NCT00350948|Drug|Liposomal Doxorubicin|Day 1 of 28 Day Cycle. 50 mg/m2
12032107|NCT00350935|Procedure|fMRI|One 30 minute session
12032108|NCT00350922|Behavioral|Psychoeducation|
12032109|NCT00350909|Behavioral|brief intervention (cognitive-behavioral therapy)|Consists of 60 minute individual sessions delivered with a therapist using a motivational interviewing (MI) style. Session 1 focuses on eliciting information about the students' substance use and related consequences based on the assessment, their perception of level of willingness to change, examining the cause and benefits of change using the decisional balance exercise, and discussing what goals for change the student would like to select and pursue. Session 2 reviewed the students' progress with the agreed upon goals, identifying high risk situations associated with clients difficulty in achieving the goals, discussing strategies to address barriers toward goal attainment, reviewing where the client is in the stage of change process, and negotiating either the continuation of goals or advancing to more ambitious goals of substance use reduction. Session 3 involved delivering the same MI interviewing style to the primary parent or guardian (student is not present).
12032110|NCT00350896|Device|Thumb orthoses|
12032111|NCT00350883|Behavioral|Cognitive Therapy|Goal-oriented talk therapy
12032112|NCT00350883|Other|Treatment as Usual|Keep getting usual care
12032113|NCT00350870|Drug|disulfiram|250mg per day of Disulfiram plus CBT
12032114|NCT00350870|Drug|Placebo|Placebo plus CBT
12032115|NCT00350870|Behavioral|Placebo plus Contingency Management|Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
12032116|NCT00350870|Drug|Disulfiram plus Contingency Management|250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
12032117|NCT00350857|Drug|Extended-Release Carbamazepine|
12032118|NCT00350844|Drug|Hydroxyurea|20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
12032119|NCT00350831|Drug|XL820|
12032120|NCT00350818|Drug|Azacitidine|8 mg/m^2 Subcutaneously Once Daily for 5 Days
12032121|NCT00350805|Procedure|EEG|One 20 minutes session
12032122|NCT00350792|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles
12032123|NCT00350792|Drug|carboplatin|Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
12032124|NCT00350779|Drug|sitagliptin|Sitagliptin 100mg tablet each day for 54 weeks. All subjects will be given placebo to sitagliptin for a 2 week period.
12032125|NCT00350779|Drug|Comparator: Placebo|Placebo to sitagliptin 100mg tablet each day for 54 weeks.
12032173|NCT00350428|Procedure|Laser Preipheral Iridotomy and phacoemulsification|
12032126|NCT00350779|Drug|rosiglitazone|Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
12032127|NCT00350779|Drug|metformin|Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
12032128|NCT00350779|Drug|glipizide|Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.)
12032129|NCT00350766|Procedure|Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation|Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.
12032130|NCT00350753|Drug|Erlotinib and bevacizumab|Erlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days
12032131|NCT00350727|Drug|pazopanib|Pazopanib is a novel compound being developed for the treatment of various cancers.
12032132|NCT00350727|Drug|lapatinib|Lapatinib is a novel compound being developed for the treatment of various cancers.
12032133|NCT00350714|Other|MBT and BreathID|75 mg methacetin (c13 labelled) dissolved in 150 cc water ingested and breath collected before and after ingestion.
12032134|NCT00350701|Drug|androgel|androgel 5g
12032135|NCT00350701|Drug|androgel 10g|androgel 10g
12032136|NCT00350701|Drug|placebo|placebo
12032137|NCT00350688|Radiation|Helical tomotherapy IMRT|Helical tomotherapy IMRT
12032138|NCT00350662|Drug|Deferiprone (L1)|75 mg/kg body weight daily
12032139|NCT00350662|Drug|Desferrioxamine|In combination with deferiprone: 40-50 mg/kg body weight 2-times weekly As single agent: 40-50 mg/kg body weight 5- to 7-times weekly
12032140|NCT00350649|Behavioral|Standard CBT|Manualized delivery of CBT by trained clinicians
12032141|NCT00350649|Behavioral|CBT+CM/adherence|CBT and Clinical Management for attendance and completing homework
12032142|NCT00350649|Behavioral|CM/abstinence|Contingency Management
12032143|NCT00350649|Behavioral|CM/abstinence+CBT|Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician
12032144|NCT00350636|Drug|Oxybutynin topical gel|1 application daily to skin for 12 weeks
12032145|NCT00350636|Other|Placebo topical gel|1 application daily to skin for 12 weeks
12032146|NCT00350623|Biological|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)|3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
12032147|NCT00350623|Biological|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)|3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
12032148|NCT00350623|Biological|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)|3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
12032149|NCT00350610|Other|Treatment as usual (TAU)|Standard treatment as usual in a community based treatment setting
12032150|NCT00350610|Behavioral|CBT for CBT|Standard treatment as usual (TAU) plus computer based therapy using CBT
12032151|NCT00350597|Drug|Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)|
12032152|NCT00350584|Behavioral|Mindfulness Telehealth Intervention|Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.
12032153|NCT00350584|Behavioral|Psychoeducation Telehealth Intervention|Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.
12032154|NCT00350571|Behavioral|brief (behavioral therapy)|up t 3 sessions of phone or office based counseling sessions to promote re-engagement in treatment.
12032155|NCT00350571|Behavioral|Drop out re-engagement motivational intervention|Up to 3 phone or office based counseling sessions to promote reengagement in treatment
12032156|NCT00350571|Behavioral|standard care follow up|routine counselor phone calls and letters
12032157|NCT00350545|Drug|Rituximab|375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
12032158|NCT00350545|Drug|Prednisone|1 mg/kg; po per day with taper
12032159|NCT00350545|Drug|Cyclosporine A|trough 200-300 or lower; po
12032160|NCT00350545|Drug|tacrolimus|trough 5-10 or lower; po
12032161|NCT00350532|Drug|clonidine|Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
12032162|NCT00350532|Drug|clonidine|Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
12032163|NCT00350519|Drug|Epoetin alfa|Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
12032164|NCT00350519|Drug|Standard of Care|Participants will receive standard of care based on the Institution's treatment policy.
12032165|NCT00350506|Device|64 Channel VCT|
12032166|NCT00350480|Drug|Provera|
12032167|NCT00350480|Drug|Combination Birth Control pills|
12032168|NCT00350467|Drug|ER OROS paliperidone and Olanzapine|
12032169|NCT00350454|Device|rapamycin-eluting Stent with permanent polymer|due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
12032170|NCT00350454|Device|rapamycin-eluting stent with biodegradable polymer|due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
12032171|NCT00350454|Device|polymer-free, rapamycin-eluting stent|due to randomization, polymer-free.rapamycin-eluting stent will be implanted
12032172|NCT00350441|Drug|Sildenafil Citrate|
12032174|NCT00350415|Drug|Mesalamine|"Asacol 400g/day (400 mg tablet), oral, for 6 weeks
~OR
~Asacol 4,8 g/day (800 mg table), oral, for 6 weeks"
12032175|NCT00350402|Behavioral|Respiratory muscle strength training|The Muscle Stength Training (MST)device is a mouthpiece that the participant uses to inspire against controlled resistance; Intervention involves use of this device for breathing exercises over 4 week period, 5 days a week, approximately 20 minutes/day.
12032176|NCT00350389|Behavioral|Outdoor use of plain distance glasses with counselling|Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
12032177|NCT00350363|Drug|Zymar|zymar qid
12032178|NCT00350350|Device|oxygenated oil|oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day
12032179|NCT00350350|Device|medical device. Spray containing essentially oxygenated oil|"protective oral spray containing :
~94.4% of oxygenated oil
~Silicium dioxide
~aspartame artificial flavoring"
12032180|NCT00350337|Biological|Pre-transfection F17|Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection
12032181|NCT00350337|Biological|Post-transfection F17|Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.
12032182|NCT00350337|Biological|Post-transfection F19|Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.
12032183|NCT00350337|Other|Placebo|Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection
12032184|NCT00350311|Drug|nicotine transdermal patch/lozenge|
12032185|NCT00350298|Biological|GS-CDA1|one dose IV
12032186|NCT00350298|Biological|MDX-1388|one dose IV
12032187|NCT00350298|Biological|normal saline|200ml IV once
12032188|NCT00350285|Behavioral|Motivational enhancement therapy|Personal feedback with counselor using motivational interviewing strategies.
12032189|NCT00350285|Behavioral|Marijuana education|Information about health and behavioral effects of marijuana use.
12032190|NCT00350272|Drug|elvucitabine|elvucitabine 10 mg orally daily
12032191|NCT00350272|Drug|Lamivudine|lamivudine 300 mg orally daily
12032192|NCT00350272|Drug|Tenofovir|tenofovir open-label 300 mg orally daily
12032193|NCT00350272|Drug|Efavirenz|efavirenze open-label 600 mg orally daily
12032194|NCT00350246|Procedure|Laser Refractive Surgery|
12032195|NCT00350233|Device|ExAblate 2000|
12032196|NCT00350220|Other|transfusion strategy|For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl
12032197|NCT00350220|Other|Low Hb transfusion group|RBCs will not be transfused unless the Hb < 9.0 g/dl
12032198|NCT00350207|Drug|Tiotropium bromide|
12032199|NCT00350207|Drug|Placebo|
12032200|NCT00350207|Drug|Salmeterol xinafoate|
12032201|NCT00350194|Dietary Supplement|Omega-3 fatty acids|Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
12032202|NCT00350181|Drug|Sirolimus|
12032203|NCT00350181|Drug|Mycophenolate Mofetil|
12032204|NCT00350168|Drug|valsartan + amlodipine|
12032205|NCT00350155|Drug|Lumiracoxib|
12032206|NCT00350142|Radiation|Stereotactic Body Radiotherapy|Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator
12032207|NCT00350142|Drug|Gemcitabine|Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes
12032208|NCT00350142|Other|4D pancreatic protocol CT scan|Patients will undergo this imaging procedure prior to treatment for planning purposes.
12032209|NCT00350142|Radiation|FDG PET scan|Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.
12032210|NCT00350116|Drug|topical vitamin B12|
12032211|NCT00350103|Drug|SPM 929|
12032212|NCT00350090|Drug|Epoetin Alfa|
12032213|NCT00350077|Drug|Intravenous Vitamin C|vitamin C IV during 24 hour period following burn
12032214|NCT00350077|Drug|Vitamin C|IV vitamin C
12032215|NCT00350064|Behavioral|Exercise Training|16 weeks of aerobic exercise training at two different intensities
12032216|NCT00350051|Drug|Sagopilone (ZK 219477) + prednisone|Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.
12032217|NCT00350038|Drug|Irbesartan|
12032218|NCT00350038|Drug|Ciprofibrate|
12032219|NCT00350025|Drug|Cetuximab|Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
12032220|NCT00350025|Drug|Paclitaxel|Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
12032221|NCT00349986|Drug|Insuline glargine|
12032222|NCT00349973|Drug|Dipyridamole|Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
12032223|NCT00349973|Other|Olanzapine|Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
12032224|NCT00349960|Drug|NeoRecormon SC once-weekly versus once-every-other-week|
12032225|NCT00349947|Behavioral|Exercise Program|Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor.
12032275|NCT00349570|Device|Xtract Aspiration Catheter|
12032276|NCT00349557|Drug|bevacizumab, bicalutamide and goserelin|
12032277|NCT00349557|Procedure|intensity modulated radiation therapy (IMRT)|
12032278|NCT00349531|Drug|Pramipexole|
12032279|NCT00349518|Drug|Dasatinib|
12032280|NCT00349505|Procedure|hyper thermic chemo + surgery|
12032281|NCT00349492|Drug|IP|irinotecan+cisplatin
12032226|NCT00349934|Biological|IMP321|"This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle).
~Three IMP321 dose levels (250 µg, 1,250 µg and 6,250 µg) will be evaluated in three cohorts of 8 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks (12 s.c. injections in total), separated by 13-day intervals free of IMP321 administration.
~The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy."
12032227|NCT00349921|Drug|clonidine|Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.
12032228|NCT00349921|Drug|adenosine|Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.
12032229|NCT00349921|Drug|placebo|inactive substance
12032230|NCT00349921|Drug|placebo|inactive substance
12032231|NCT00349908|Device|Cordis Neurovascular ENTERPRISE Self Expanding Stent System|Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
12032232|NCT00349908|Device|Cordis Neurovascular ENTERPRISE Self Expanding Stent System|Implantation of the device ENTERPRISE to treat wide-necked aneurysms
12032233|NCT00349895|Device|Coronary stent implantation|Percutaneous Coronary Intervention
12032234|NCT00349882|Device|soft contact lens|
12032235|NCT00349882|Drug|Marketed multipurpose disinfection regimen|
12032236|NCT00349869|Behavioral|yoga|8-week yoga program.
12032237|NCT00349856|Device|Biofinity|Soft contact lens
12032238|NCT00349843|Device|Soft contact lens|
12032239|NCT00349843|Drug|Marketed soft lens multipurpose disinfection regimen|
12032240|NCT00349830|Procedure|blood draw|
12032241|NCT00349817|Behavioral|web-based learning, didactic lecture and role-play|
12032242|NCT00349804|Other|cool dry air|cool dry air (0.22-0.28 m3/min at 15-18 Degrees C)
12032243|NCT00349791|Drug|Testosterone Transdermal System|testosterone (300 mcg/day) patch replaced twice a week for two years
12032244|NCT00349791|Drug|Placebo patch|placebo patch replaced twice a week for two years
12032245|NCT00349778|Drug|Cyclophosphamide|Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in ~250 mL of saline or D5W and infused IV over 2 hours
12032246|NCT00349778|Drug|Etoposide|100 mg etoposide as 5 mL solution in clear ampules for injection.
12032247|NCT00349778|Drug|Melphalan|Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.
12032248|NCT00349778|Drug|Carmustine|Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.
12032249|NCT00349778|Drug|Filgrastim|Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
12032250|NCT00349765|Behavioral|higher fat, high polyunsaturated fat diet|
12032251|NCT00349765|Behavioral|higher fat, high saturated and trans fat diet|
12032252|NCT00349765|Behavioral|lower fat diet|
12032253|NCT00349752|Biological|certolizumab pegol 400 mg|Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
12032254|NCT00349752|Other|Placebo|Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
12032255|NCT00349739|Drug|Anecortave Acetate|Dosage: 0.5ml of 30mg/ml(15 mg) or 60mg/ml(30mg) Duration of action: 159-180 days
12032256|NCT00349726|Drug|Inositol lower volume|60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
12032257|NCT00349726|Drug|Inositol higher volume|120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
12032258|NCT00349726|Drug|Placebo lower volume|60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes.
12032259|NCT00349726|Drug|Placebo higher volume|120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes.
12032260|NCT00349713|Biological|FMP2.1/AS02A|FMP2.1 in GSK Biologicals' AS02A
12032261|NCT00349713|Biological|Rabies vaccine (RabAvert)|RabAvert Rabies vaccine
12032262|NCT00349700|Procedure|Compression: 2 weeks four layer bandages, then stockings|
12032263|NCT00349700|Procedure|debridement|
12032264|NCT00349700|Procedure|Actisorb plus (r) + Trionic(r)/ Allevyn (r)|
12032265|NCT00349687|Behavioral|self-control practice|
12032266|NCT00349674|Drug|Azathioprine: 2 mg/kg/day|
12032267|NCT00349674|Drug|methotrexate 0.3 mg/kg/week, to a maximum and optimal dose of 25 mg/week|
12032268|NCT00349661|Drug|impact on VASP test|
12032269|NCT00349648|Procedure|acromioplasty|
12032270|NCT00349635|Drug|Metformin and Metformin + Fenofibrate|
12032271|NCT00349622|Drug|ceftriaxone|"Participants will be randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. Two thirds of participants will receive ceftriaxone and one third will receive placebo. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
~Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Also, ceftriaxone has not been given to people over a long period of time, such as months or years."
12032272|NCT00349622|Other|placebo|an inactive substance
12032273|NCT00349596|Drug|Decitabine|Administered intravenously (IV) over 1 hour at 10 mg/m2 daily x 5 days every other week.
12032274|NCT00349583|Drug|Topical Cyclosporine, Tears|
12032582|NCT00347035|Drug|brimonidine|
12032282|NCT00349479|Behavioral|Barrier assessment / interactive educational intervention|"Intervention hospitals received a barrier assessment - interactive educational intervention (BA-IEI) which included: on-site barrier assessment, annual stroke champions meetings, stroke center telephone access, quarterly mock stroke codes, and ongoing feedback and education."
12032283|NCT00349466|Drug|CF101|Orally CF101 1mg
12032284|NCT00349466|Drug|Placebo|Orally matching Placebo
12032285|NCT00349453|Drug|Deferiprone (L1)|50-100 mg/kg body weight daily
12032286|NCT00349453|Drug|Deferiprone (L1)|75 mg/kg body weight daily
12032287|NCT00349453|Drug|Desferrioxamine|35-50 mg/kg body weight on 2 or more days per week
12032288|NCT00349440|Drug|Cyclosporine, Refresh Plus|"Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
~Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily."
12032289|NCT00349427|Drug|Rosiglitazone 4 mg|
12032290|NCT00349414|Procedure|Micropulse Transscleral Cyclophotocoagulation|
12032291|NCT00349414|Procedure|Conventional Transscleral Cyclophotocoagulation|
12032292|NCT00349401|Drug|ketorolac|
12032293|NCT00349401|Drug|morphine|
12032294|NCT00349388|Drug|Asacol|Asacol is given once a day versus twice or three times a day
12032295|NCT00349375|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate 145mg and Simvastatin 20mg
12032296|NCT00349375|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 40 mg
12032297|NCT00349375|Drug|Simvastatin|Simvastatin 40 mg
12032298|NCT00349362|Drug|Testosterone|Sustanon- 200mg intramuscular testosterone
12032299|NCT00349362|Drug|0.9% saline|Saline intramuscular injection every two weeks
12032300|NCT00349349|Drug|ofatumumab|Intravenous infusion
12032301|NCT00349336|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 of each 3 week cycle
12032302|NCT00349336|Drug|XELOX|As prescribed
12032303|NCT00349336|Drug|bevacizumab [Avastin]|5mg/kg iv on day 1 of each 2 week cycle
12032304|NCT00349336|Drug|FOLFOX-4|As prescribed
12032305|NCT00349323|Behavioral|Community directed treatment|
12032306|NCT00349310|Drug|Pramipexole|
12032307|NCT00349284|Drug|Combination of 145 mg fenofibrate and 10 mg ezetimibe|
12032308|NCT00349271|Procedure|Stem cell|Stem cell
12032309|NCT00349271|Drug|Filgrastime (G-CSF)|Filgrastime (G-CSF)
12032310|NCT00349271|Drug|Standart therapy|All drug with clinical evidence of benefical effect in Chagas disease
12032311|NCT00349258|Drug|Leuprolide acetate|
12032312|NCT00349245|Drug|Remifentanil|
12032313|NCT00349245|Drug|Dexmedetomidine|
12032314|NCT00349232|Behavioral|lifestyle intervention (diet and physical activity)|
12032315|NCT00349219|Drug|erlotinib|erlotinib 150 mg taken orally daily until disease progression
12032316|NCT00349219|Drug|cisplatin|cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy
12032317|NCT00349219|Drug|gemcitabine|gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line
12032318|NCT00349219|Drug|cisplatin|cisplatin 80 mg/m2 IV day 1 every 3 weeks for 6 cycles
12032319|NCT00349219|Drug|gemcitabine|gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks for 6 cycles
12032320|NCT00349219|Drug|erlotinib|erlotinib 150 mg orally taken daily as second line therapy (after disease progression on chemotherapy)
12032321|NCT00349206|Drug|sorafenib tosylate|Given orally
12032322|NCT00349206|Drug|temsirolimus|Given IV
12032323|NCT00349193|Drug|laquinimod 0.3|laquinimod 0.3mg
12032324|NCT00349193|Drug|laquinimod 0.6|laquinimod 0.6mg
12032325|NCT00349193|Other|Placebo|Blinded Placebo
12032326|NCT00349180|Drug|Enoxaparin sodium|
12032327|NCT00349167|Drug|PR-104|
12032328|NCT00349167|Other|laboratory biomarker analysis|
12032329|NCT00349167|Other|pharmacological study|
12032330|NCT00349141|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|
12032331|NCT00349128|Drug|fenofibrate and metformin combination (drug)|
12032332|NCT00349115|Drug|Thalidomide|
12032333|NCT00349102|Radiation|Free breathing|Free breathing during conformal radiation
12032334|NCT00349102|Radiation|Breath holding|Breath holding during conformal radiation
12032335|NCT00349089|Drug|Pemetrexed|Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22
12032336|NCT00349089|Drug|Cisplatin|"Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22
~Comparator:
~Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29 Cisplatin 50 mg/m2 d1, 8; q d29"
12032337|NCT00349089|Drug|Vinorelbine|Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29
12032338|NCT00349076|Drug|5-FU and oxaliplatin|"Preoperative radiochemotherapy:
~Oxaliplatin: 50 mg/m² i.v., days 1, 8, 22 und 29; 5-Fluorouracil: 250 mg/m²/d continuous infusion, days 1-14 and 22-35
~Adjuvant Chemotherapy:
~Oxaliplatin: 100 mg/m² i.v. on day 1; Calciumfolinate: 400 mg/m² on day 1; 5-Fluorouracil: 2400 mg/m² continuous infusion for 46 hours repeat day 15, 8 cycles"
12032339|NCT00349076|Drug|5-FU|"Preoperative radiochemotherapy:
~5-Fluorouracil: Days 1-5 and 29-33: 120h-continuous infusion 1000 mg/m²/d
~Adjuvant Chemotherapy: 5-Fluorouracil: 500 mg/m² on 5 consecutive days (day 1-5) i.v. bolus fot 2-5 minutes; repeat day 29, 4 cycles"
12032340|NCT00349063|Device|soft contact lens|
12032341|NCT00349063|Drug|Soft contact lens multipurpose disinfection regimen|
12032342|NCT00349050|Device|laboratory pain assessment|Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
12032343|NCT00349050|Procedure|transcranial magnetic stimulation|"There will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and sham TMS (which does not involve real stimulation) for the second treatment. Group B will receive sham TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and sham TMS."
12032344|NCT00349037|Biological|Trivalent DNA vaccine with and without pPJV2012 administered by PMED|
12032345|NCT00349024|Drug|polyvinylpyrrolidone-sodium hyaluronate gel|
12032346|NCT00349011|Procedure|Personalized risk assessment|
12032347|NCT00349011|Procedure|genetic counseling intervention|
12032348|NCT00348998|Biological|bevacizumab|
12032349|NCT00348998|Drug|bicalutamide|
12032350|NCT00348998|Drug|goserelin acetate|
12032351|NCT00348998|Radiation|radiation therapy|
12032352|NCT00348985|Drug|belinostat|
12032353|NCT00348985|Drug|bortezomib|
12032354|NCT00348985|Other|pharmacological study|
12032355|NCT00348972|Drug|Lantus® (insulin glargine)|
12032356|NCT00348959|Behavioral|'Open Window' Project|"Open Window' is an entirely art based intervention comprising a multimedia system that uses a combination of video projectors, audio speakers and bespoke software to make images appear as a 'virtual window' on the wall of the patients' room. Artists use mobile phone cameras and camcorders to record the images that are sent to the unit over the internet and via mobile phone networks. Original music composed for the project may also accompany the images as they appear.
~Artists are commissioned to create work for the 'Open Window' project and are aware of the nature of the viewer and the context in which the art will be shown. The art in 'Open Window' encourages the viewer to think about and engage in what they see from their own personal frame of reference."
12032357|NCT00348946|Drug|androgen oxandrolone|Oxandrolone or placebo capsule, .06 >mg/kg/day, orally, for 2 years
12032358|NCT00348946|Other|placebo|an inactive substance
12032359|NCT00348933|Drug|Betaine|100-200 mg per kg per day by mouth with a maximum of 6 grams divided in two daily doses
12032360|NCT00348933|Drug|Creatine|200 mg per kg per day with a daily maximum of 5 grams divided in two daily doses
12032361|NCT00348933|Drug|Metafolin|0.5 mg per kg per day by mouth with a maximum of 8 milligrams divided in two daily doses
12032362|NCT00348933|Drug|Vitamin B12|1 mg by mouth per day for all weights and ages
12032363|NCT00348920|Procedure|High Spinal and General Anesthesia|Spinal bupivacaine 0.75% in dextrose, 6 mls (45mg) and preservative free morphine 3 mcg/kg (to a maximum of 300 mcg).
12032364|NCT00348907|Drug|thermal cure|thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
12032365|NCT00348907|Drug|late thermal cure|thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years
12032366|NCT00348894|Drug|[S,S]-Reboxetine|[S,S]-reboxetine
12032367|NCT00348894|Drug|Any|Any standard of care treatment for DPN
12032368|NCT00348881|Biological|DTaP-HB-PRP~T combined vaccine|0.5 mL, Intramuscular
12032369|NCT00348881|Biological|Tritanrix-HepB/Hib™ vaccine|0.5 mL, Intramuscular
12032370|NCT00348881|Biological|Oral poliomyelitis vaccine (OPV)|Oral co-administered with study vaccine.
12032371|NCT00348868|Behavioral|enhanced behavioral motivation counseling|
12032372|NCT00348868|Behavioral|Motivational counseling|
12032373|NCT00348868|Behavioral|Standard counseling|
12032374|NCT00348855|Other|Cardiovascular drugs strategies|Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.
12032375|NCT00348855|Behavioral|Compliance|Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.
12032376|NCT00348855|Behavioral|Exercise|Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.
12032377|NCT00348855|Behavioral|Stop Smoking|Minimal intervention
12032378|NCT00348855|Behavioral|Diet|Discussion with the patient on his (her) alimentation during each of the six consultations and assessment of daily diet at inclusion, year 1 and year 2.
12032379|NCT00348855|Other|Feed Back|Feed back on results in the intervention group at baseline, Year 1 ans Year 2.
12032380|NCT00348842|Procedure|Newcastle Virus|
12032381|NCT00348829|Procedure|mitral valve repair|surgical mitral valve repair
12032382|NCT00348816|Drug|docetaxel|Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
12032383|NCT00348816|Drug|prednisone|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
12032384|NCT00348816|Procedure|Radical prostatectomy|Radical prostatectomy as part of standard care
12032385|NCT00348816|Radiation|Radiation therapy|Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
12032386|NCT00348790|Drug|vatalanib|
12032387|NCT00348777|Drug|thermal cure|thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
12032388|NCT00348777|Drug|3 days access to watering place at 6 months|access to watering place for movement in swimming pool, sauna and hammam.
12032389|NCT00348764|Drug|lauromacrogol|
12032390|NCT00348751|Device|CholGate|
12032391|NCT00348738|Drug|Erythropoietin|Administration of 10.000 I.U Erythropoeitin SQ 3x/week, two weeks prior to radiation therapy until a haemoglobin concentration of >14g/dl, <15g/dl is reached or until the end of the radiation therapy.
12032392|NCT00348725|Drug|fenofibrate and metformin fixed combination (drug)|
12032393|NCT00348712|Drug|rosiglitazone|Tablets, 4 mg once or twice daily.
12032394|NCT00348712|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
12032395|NCT00348712|Drug|metformin|Tablets, 2000 mg/day.
12032396|NCT00348699|Drug|AFP464|Given IV
12032397|NCT00348699|Other|pharmacological study|Correlative studies
12032398|NCT00348699|Other|laboratory biomarker analysis|Correlative studies
12032399|NCT00348686|Drug|Candesartan|16 mg once daily in oral tablet form
12032400|NCT00348686|Drug|Candesartan|32 mg once daily in oral tablet form
12032401|NCT00348686|Drug|Felodipine|5 mg once daily in oral tablet form
12032402|NCT00348686|Drug|Felodipine|10 mg once daily in oral tablet form
12032403|NCT00348673|Drug|UK-453,061|Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days
12032824|NCT00345098|Drug|SR58611A|
12032404|NCT00348673|Drug|UK-453,061|Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days
12032405|NCT00348647|Behavioral|physical training program to prevent injuries|
12032406|NCT00348634|Drug|Tegaserod|
12032407|NCT00348621|Procedure|Visual impairment intervention program|enhanced access to eye care services
12032408|NCT00348608|Drug|iodixanol|
12032409|NCT00348595|Drug|Revlimid|one 5 mg/day capsule or one 25 mg/day capsule with matched placebo capsule day 1-21 (28 day cycle)
12032410|NCT00348582|Drug|Ketorolac, Nepafenac|
12032411|NCT00348569|Device|64 Channel VCT|
12032412|NCT00348556|Drug|Nesiritide|Nesiritide 0.005 ug/kg/min IV for 6 hours, then to 0.01 ug/kg/min for 6 hours then to 0.02ug/kg/min for 6 hours then to 0.03 ug/kg/min for the last 6 hours.
12032413|NCT00348543|Procedure|laser treatment|
12032414|NCT00348530|Drug|Verapamil|
12032415|NCT00348517|Other|Systane Free Lubricant Eye Drops|1-2 drops per eye four times per day for 42 days
12032416|NCT00348517|Other|Refresh Liquigel Lubricant Eye Drops|1-2 drops per eye four times per day for 42 days
12032417|NCT00348504|Drug|levosimendan|
12032418|NCT00348504|Drug|dobutamine|
12032419|NCT00348491|Drug|Lumiracoxib|
12032420|NCT00348478|Behavioral|water and health education program to improve hygiene|
12032421|NCT00348465|Procedure|Brachytherapy with Iodine-125 seeds|Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS
12032422|NCT00348452|Drug|tramadol HCl ER; celecoxib|
12032423|NCT00348439|Drug|Plasmin|27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
12032424|NCT00348439|Drug|Vehicle|Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.
12032425|NCT00348426|Drug|Botulinum AntiToxin|
12032426|NCT00348426|Procedure|neuro-electrophysiologic study, repetitive nerve stimulation|
12032427|NCT00348426|Procedure|: Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure|
12032428|NCT00348413|Drug|Intravenous Methylprednisolone + Oral Methotrexate vs Intravenous Methylprednisolone + Placebo|
12032429|NCT00348400|Drug|Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost|
12032430|NCT00348387|Biological|Poliomyelitis Vaccine inactivated|0.5 mL, Intramuscular
12032431|NCT00348387|Biological|Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)|1g dragee, oral
12032432|NCT00348374|Drug|Insulin Lispro|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
12032433|NCT00348374|Drug|Exubera|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
12032434|NCT00348361|Drug|Fluticasone Propionate|
12032435|NCT00348348|Drug|Besifloxacin|Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days
12032436|NCT00348348|Drug|Moxifloxacin solution|Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
12032437|NCT00348335|Drug|Cyclosporine 0.05%|
12032438|NCT00348335|Drug|Ocular lubricant|
12032439|NCT00348322|Drug|Systane Free Lubricant Eye Drops|
12032440|NCT00348309|Drug|Rosiglitazone Extended Release 2mg|Rosiglitazone Extended Release 2mg OD
12032441|NCT00348309|Drug|Rosiglitazone Extended Release 8mg|Rosiglitazone Extended Release 8mg OD
12032442|NCT00348309|Other|Placebo|Placebo
12032443|NCT00348309|Other|Donepezil|Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
12032444|NCT00348296|Drug|High-dose intravenous immunoglobulin (Venoglobulin-IH)|
12032445|NCT00348283|Biological|adalimumab|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
12032446|NCT00348283|Biological|placebo|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
12032447|NCT00348283|Biological|adalimumab|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.
12032448|NCT00348270|Device|Tecnis Z9000 intraocular lens|
12032449|NCT00348270|Device|MA60 intraocular lens|
12032450|NCT00348257|Device|Hair removal by laser/IPL device|
12032451|NCT00348244|Drug|Ketorolac, Prednisolone Acetate|
12032452|NCT00348231|Drug|dual-action insulin analog|
12032453|NCT00348218|Device|NeuroVision|
12032454|NCT00348205|Device|Technolas 217z Zyoptix Laser|Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
12032455|NCT00348192|Drug|SB-742457|
12032456|NCT00348192|Drug|donepezil|
12032457|NCT00348179|Procedure|Measurement of vascular function per SphymgnoCor equipment|Pressure tonometer will be used on various vessels, non-invasive.
12032458|NCT00348166|Drug|cyclopentolate|
12032459|NCT00348153|Drug|Adalimumab|
12032460|NCT00348140|Drug|Rosiglitazone Extended Release 2mg|Rosiglitazone Extended Release 2mg OD
12032461|NCT00348140|Drug|Rosiglitazone Extended Release 8mg|Rosiglitazone Extended Release 8mg OD
12032462|NCT00348140|Other|Placebo|Placebo
12032463|NCT00348127|Device|Neurovision|
12032464|NCT00348114|Procedure|Transplantation of cultivated limbal epithelium|
12032465|NCT00348101|Drug|Combined therapy with enoximone and esmolol|
12032466|NCT00348075|Device|Neurovision|
12032467|NCT00348062|Drug|Bimatoprost|
12032468|NCT00348049|Procedure|Laser in Situ Keratomileusis (LASIK)|
12032469|NCT00348049|Procedure|Photorefractive Keratectomy (PRK)|
12032470|NCT00348036|Behavioral|Group Intervention for Interpersonal Trauma|Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier.
12032471|NCT00348036|Other|Information only|Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.
12032472|NCT00348023|Drug|Bimatoprost 0.03%, Travoprost 0.004%, Timolol 0.5%|
12032473|NCT00348010|Drug|Tramadol HCl ER|
12032474|NCT00347997|Device|217z Laser|LASIK correction of myopia and myopic astigmatism
12032475|NCT00347984|Other|Systane Lubricant eye drops|
12032476|NCT00347971|Drug|recombinant human interleukin 21 and rituximab|rIL-21 (30, 100, 150 ug/kg) IV rituximab (375 mg/m2) IV
12032477|NCT00347958|Biological|Tetanus-diphtheria-acellular pertussis (Tdap) vaccine|0.5mL, Intramuscular (IM)
12032478|NCT00347945|Procedure|Pencil Push-ups|
12032479|NCT00347945|Procedure|Office-based Vision Therapy|
12032480|NCT00347945|Procedure|Placebo Office-based Vision Therapy|
12032481|NCT00347932|Drug|ISV-403|Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
12032482|NCT00347932|Drug|Vehicle|Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.
12032483|NCT00347919|Drug|pazopanib (GW786034) 400 mg|400 mg administered orally once daily
12032484|NCT00347919|Drug|lapatinib (GW572016) 1500 mg|1500 mg administered orally once daily.
12032485|NCT00347919|Drug|lapatinib (GW572016) 1000 mg|1000 mg administered orally once daily
12032486|NCT00347919|Drug|pazopanib (GW786034) 800 mg|800 mg administered orally once daily
12032487|NCT00347906|Procedure|laser treatment|
12032488|NCT00347893|Procedure|Selective laser trabeculoplasty|
12032489|NCT00347867|Drug|Viagra administration in IUGR/PET pregnancies|
12032490|NCT00347854|Other|Systane Free lubricant eye drops|
12032491|NCT00347854|Other|Visine Tears Lubricant Eye Drops|
12032492|NCT00347854|Other|Refresh Liquigel Lubricant Eye Drops|
12032493|NCT00347854|Other|Refresh Plus Lubricant Eye Drops|
12032494|NCT00347841|Drug|Bimatoprost 0.03%, Latanoprost|
12032495|NCT00347828|Drug|Moxifloxacin ophthalmic solution 0.5%|
12032496|NCT00347828|Drug|Gatifloxacin ophthalmic solution 0.3%|
12032497|NCT00347815|Drug|Buprenorphine|
12032498|NCT00347802|Drug|Bimatoprost 0.03%, Travoprost 0.004%|
12032499|NCT00347789|Procedure|Glaucoma surgery- Bleb revision|
12032500|NCT00347776|Drug|azithromycin|oral antibiotic
12032501|NCT00347776|Drug|topical tetracycline|
12032502|NCT00347763|Procedure|10% permethrin in water applied as low volume spray|
12032503|NCT00347750|Drug|Lopinavir pharmacokinetic/pharmacodynamic analysis|
12032504|NCT00347737|Drug|teriparatide|Teriparatide
12032505|NCT00347724|Drug|Tramadol HCl ER|
12032506|NCT00347711|Drug|Intravitreal injection|
12032507|NCT00347698|Drug|intravitreal injection of bevacizumab|
12032508|NCT00347698|Procedure|panretinal photocoagulation|
12032509|NCT00347685|Drug|tramadol ER|
12032510|NCT00347672|Biological|H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)|Live, attenuated recombinant H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) vaccine (one of three doses)
12032511|NCT00347659|Drug|BLVR System|Treatment is administered in a single treatment session.
12032512|NCT00347646|Drug|Plasmin|27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection
12032513|NCT00347620|Device|spectacles|
12032514|NCT00347620|Procedure|Cataract Surgery|
12032515|NCT00347607|Behavioral|community surveillance and re-treatment|
12032516|NCT00347594|Device|Next Generation Diagnostic Instrument (NGDI)|Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
12032517|NCT00347594|Device|Zyoptix Diagnostic Workstation (ZDW)|Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
12032518|NCT00347581|Procedure|Base-in prism glasses for reading|
12032519|NCT00347581|Procedure|Placebo reading glasses|
12032520|NCT00347568|Device|TX-plore|PI has terminated at institution and there is no one available to report.
12032521|NCT00347555|Biological|Aluminum Phosphate|1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant; dosage 500 micrograms.
12032522|NCT00347555|Drug|Placebo|0.5 mL normal saline placebo. Sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride).
12032523|NCT00347555|Biological|EBA-175 RII-NG Malaria Vaccine|White, translucent, cloudy, nonparticulate liquid suspension. Recombinant Plasmodium falciparum erythrocyte-binding antigen 175 kDa Region II-nonglycosylated (EBA-175 RII-NG) absorbed to aluminum phosphate adjuvant; dosage levels 5, 20, 80, and 160 micrograms.
12032524|NCT00347542|Drug|Vitamin D|
12032525|NCT00347529|Biological|pPML7789 with and without pPJV2012 administered by PMED|
12032526|NCT00347516|Procedure|IOL calculation formula|
12032527|NCT00347503|Drug|ketorolac 0.4%, bromfenac 0.09%|
12032528|NCT00347490|Drug|Enoxaparine|
12032529|NCT00347477|Drug|HyperHAES vs. RA-solution/NaCl|
12032530|NCT00347438|Drug|Capecitabine|Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).
12032531|NCT00347425|Drug|Aripiprazole|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
12032532|NCT00347425|Drug|Olanzapine|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
12032533|NCT00347425|Drug|Risperidone|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
12032534|NCT00347425|Drug|Quetiapine|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
12032535|NCT00347425|Drug|Ziprasidone|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
12032536|NCT00347425|Drug|Aripiprazole|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
12032537|NCT00347425|Drug|Olanzapine|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
12032538|NCT00347425|Drug|Risperidone|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
12032539|NCT00347425|Drug|Quetiapine|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
12032540|NCT00347425|Drug|Ziprasidone|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
12032541|NCT00347412|Drug|Paclitaxel and Carboplatin|"Paclitaxel and carboplatin: (All randomized patients)
~All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first.
~The initial dose of chemotherapy for every patient in the trial is 200 mg/m2 of paclitaxel,as a 3 hour infusion, followed by carboplatin at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing."
12032542|NCT00347412|Drug|NOV-002 Injection in combination with Carboplatin vs. Paclitaxel and Carboplatin|"NOV-002: (Group A only)
~Two 60mg intravenous boli given 3 hours apart administered the day prior to the first administration of paclitaxel and carboplatin cycle one
~For each nominal 21-day paclitaxel and carboplatin cycle:
~60mg given intravenously on Day 1, given one hour prior to paclitaxel and carboplatin
~followed by 60mg subcutaneously daily for the next 20 days. If there is a delay in chemotherapy cycles, the patient will continue with daily, subcutaneous administration of NOV-002 until the next cycle of chemotherapy begins.
~Patients randomized to NOV-002 Group A, will receive NOV-002 until disease progression, unacceptable NOV-002 related toxicity, or discontinuation of paclitaxel and carboplatin, whichever comes first."
12032543|NCT00347399|Drug|bevacizumab intravitreal injection|
12032544|NCT00347399|Procedure|verteporfin photodynamic therapy|
12032545|NCT00347386|Drug|Drug: Zinc (zinc sulphate)|Dissolvable tablet 10 mg. Once daily during the illness
12032546|NCT00347386|Drug|Placebo|Placebo tablet, once daily
12032547|NCT00347373|Drug|Tonalin Conjugated linoleic acid (dietary supplement)|
12032548|NCT00347360|Drug|lisinopril|
12032549|NCT00347360|Drug|carvedilol controlled release formulation|
12032550|NCT00347334|Behavioral|infant home positioning|
12032551|NCT00347321|Procedure|Dilatational Percutaneous tracheostomy|Dilatational Percutaneous tracheostomy
12032552|NCT00347308|Behavioral|Eyebrow Position|Photography of brow positions
12032553|NCT00347295|Drug|Brotizolam|
12032554|NCT00347295|Drug|Estazolam|
12032555|NCT00347269|Behavioral|Cognitive-behavioral therapy|Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
12032556|NCT00347269|Drug|Psychotropic medication optimization|For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
12032557|NCT00347269|Behavioral|Treatment as Usual|Participants in the control group will receive standard treatment from their PCP.
12032558|NCT00347256|Drug|cisplatin|
12032559|NCT00347256|Procedure|targeted radiation therapy|
12032560|NCT00347256|Procedure|tumor resection|
12032561|NCT00347243|Procedure|phacoemulsification (cataract surgery)|
12032562|NCT00347230|Device|Intacs intracorneal ring insertion for the treatment of keratoconus|
12032563|NCT00347204|Drug|ketorolac (Acular LS)|
12032564|NCT00347204|Drug|Nepafenac (Nevanac)|
12032565|NCT00347178|Procedure|Laser Peripheral Iridotomy|
12032566|NCT00347165|Drug|bevacizumab intravitreal injection|
12032567|NCT00347152|Drug|Divalproex|Divalproex, 8-20% taper
12032568|NCT00347152|Drug|Divalproex|Divalproex, 8-20% taper
12032569|NCT00347139|Drug|GW642444 (25, 100 & 400 mcg/day)|25, 100 and 400mcg/dose
12032570|NCT00347139|Drug|Salmeterol 50mcg|Salmeterol 50mcg
12032571|NCT00347113|Drug|Albendazole and praziquantel|
12032572|NCT00347100|Drug|Insulin Glargine|Throughout study period
12032573|NCT00347100|Drug|Glyburide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
12032574|NCT00347100|Drug|Glyclazide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
12032575|NCT00347100|Drug|Glimiperide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
12032576|NCT00347100|Drug|Glipizide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
12032577|NCT00347100|Drug|Metformin|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
12032578|NCT00347087|Drug|Irbesartan|up-titration over 4 weeks to target dose 300 mg od
12032579|NCT00347061|Drug|afuzosin|
12032580|NCT00347048|Drug|tacrolimus|oral
12032581|NCT00347048|Drug|Placebo|oral
12032583|NCT00347022|Drug|Xenetix|300 mg of iodine/ml
12032584|NCT00347022|Drug|Visipaque|270 mg of iodine/ml
12032585|NCT00347009|Drug|adefovir dipivoxil|10mg once daily
12032586|NCT00346996|Drug|insulin levemir / aspart|for subcutaneous injection
12032587|NCT00346996|Drug|human insulin /insulin isophane|for subcutaneous injection
12032588|NCT00346983|Drug|Pegaptanib sodium|0.3mg/0.1ml intravitreal injection, every 6 weeks, up to a total of 3 injections
12032589|NCT00346983|Drug|Control|Sham injection, every 6 weeks, up to a total of 3 sham injections
12032590|NCT00346970|Drug|Extended-Release Niacin|Extended-Release Niacin tablets week 1-4 500 mg/d week 4-8 1000 mg/d week 9-12 1500 mg/d
12032591|NCT00346970|Drug|Placebo|Placebo tablets
12032592|NCT00346957|Drug|Anecortave acetate 30 mg|0.5ml administered onto the sclera once every six months for 24 months
12032593|NCT00346957|Drug|Anecortave Acetate 15 mg|0.5ml administered onto the sclera once every six months for 24 months
12032594|NCT00346957|Drug|Anecortave Acetate 3 mg|0.5ml administered onto the sclera once every six months for 24 months
12032595|NCT00346957|Other|Anecortave Acetate Vehicle|0.5ml administered onto the sclera once every six months for 24 months
12032596|NCT00346944|Procedure|Removal of dental amalgam restorations|Removal of dental amalgam restorations by patient's own dentist. Fillings will be replaced with e.g. resin based filling material, metalloceramic restorations, and ceramic materials. Rubber dam will be used during removal of amalgam restorations.
12032597|NCT00346931|Procedure|Phacoemulsification, implantation of intraocular lens|
12032598|NCT00346931|Procedure|Phacoemulsification, Implantation of IOL, trabeculotomy|
12032599|NCT00346918|Drug|Sirolimus|Standard plus Sirolimus
12032600|NCT00346918|Other|Standard|Standard
12032601|NCT00346905|Drug|Enteryx|
12032602|NCT00346892|Biological|Rotavirus (vaccine)|
12032603|NCT00346879|Drug|fondaparinux|Single 2.5 mg dose of fondaparinux or weight-based 0.03 mg/Kg dose of fondaparinux
12032604|NCT00346866|Drug|anecortave acetate|
12032605|NCT00346853|Drug|4-Methylpyrazole|15 mg/kg dose
12032606|NCT00346853|Other|saline|
12032607|NCT00346840|Drug|Misoprostol vaginal insert 25 mcg|One hydrogel polymer vaginal insert for up to 24h
12032608|NCT00346840|Drug|Misoprostol vaginal insert 50 mcg|One hydrogel polymer vaginal insert for up to 24h
12032609|NCT00346840|Drug|Misoprostol vaginal insert 100 mcg|One hydrogel polymer vaginal insert for up to 24h
12032610|NCT00346840|Drug|Misoprostol vaginal insert 200 mcg|One hydrogel polymer vaginal insert for up to 24h
12032611|NCT00346827|Drug|Apomorphine Nasal Powder|
12032612|NCT00346814|Drug|intravitreal injection|
12032613|NCT00346801|Drug|Celecoxib|100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).
12032614|NCT00346801|Drug|Cisplatin|25 mg/m^2 IV over 60 minutes on Day 1, Weeks 2-8
12032615|NCT00346801|Drug|CPT-11|30 mg/m^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.
12032616|NCT00346801|Radiation|Concurrent Thoracic Radiation Therapy|63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex.
12032617|NCT00346788|Procedure|Surgical approach for total knee arthroplasty|total knee arthroplasty surgery using minimally invasive surgery or standard technique.
12032618|NCT00346775|Drug|Beclomethasone dipropionate|Beclomethasone dipropionate
12032619|NCT00346775|Drug|Flunisolide|Flunisolide
12032620|NCT00346762|Behavioral|Education|HIV prevention education and risk reduction counselig
12032621|NCT00346749|Drug|Salmeterol|
12032622|NCT00346749|Drug|Fluticasone Propionate/Salmeterol Combination Product|
12032623|NCT00346736|Procedure|Acupuncture (Procedure)|
12032624|NCT00346723|Biological|Influvac® subunit influenza vaccine for i.m./deep s.c.injection|
12032625|NCT00346697|Drug|Omega-3 fatty acid administration|LOVAZA 1 gram capsules, 4 capsules daily
12032626|NCT00346697|Drug|Placebo|Corn-oil placebo
12032627|NCT00346684|Drug|Rituximab|
12032628|NCT00346671|Other|Rest|30 min supine rest
12032629|NCT00346671|Other|Sham|30 min session with Sham practitioner
12032630|NCT00346671|Other|Reiki|30 min session with Reiki practitioner
12032631|NCT00346658|Drug|magnesium|
12032632|NCT00346645|Drug|Bortezomid (VELCADE®)|
12032633|NCT00346632|Drug|KW-2449|Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).
12032634|NCT00346619|Drug|Nelfinavir|
12032635|NCT00346606|Drug|Denosin® and Xyzal®|
12032636|NCT00346593|Device|Silicone hydrogel contact lens|
12032637|NCT00346580|Drug|Nelfinavir|
12032638|NCT00346567|Drug|Zidovudine and Lamivudine (Combivir)|
12032639|NCT00346567|Drug|Emtricitabine and Tenofovir (Truvada)|
12032640|NCT00346528|Drug|Next Generation Ophthalmic Irrigating Solution (NGOIS)|Volume sufficient to irrigate adequately during cataract surgery
12032641|NCT00346528|Drug|BSS Plus|Volume sufficient to irrigate adequately during cataract surgery
12032642|NCT00346515|Device|FiberNet Emboli Protection System|
12032643|NCT00346502|Drug|20% betulinic acid ointment|
12032644|NCT00346502|Drug|BA|20% Betulinic Acid Ointment
12032645|NCT00346489|Drug|5-fluorouracil|
12032646|NCT00346489|Drug|Mitomycin C|
12032647|NCT00346463|Drug|Allopurinol|
12032648|NCT00346450|Procedure|Cultivated conjunctival transplantation|
12032649|NCT00346437|Genetic|Ad5FGF-4 vs. Placebo|Intracoronary infusion
12032650|NCT00346424|Drug|Alfimeprase|
12032651|NCT00346398|Biological|Oral mucosal immunoprophylaxis (OMIP)|OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.
12032652|NCT00346398|Biological|Placebo|The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
12032653|NCT00346385|Drug|BB-10901|dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.
12032654|NCT00346359|Biological|anti-thymocyte globulin|
12032655|NCT00346359|Drug|busulfan|
12032656|NCT00346359|Drug|fludarabine phosphate|
12032657|NCT00346359|Drug|methotrexate|
12032658|NCT00346359|Drug|tacrolimus|
12032659|NCT00346359|Procedure|allogeneic hematopoietic stem cell transplantation|
12032660|NCT00346359|Procedure|peripheral blood stem cell transplantation|
12032661|NCT00346333|Drug|Lutein|12mg/d
12032662|NCT00346333|Dietary Supplement|Cornstarch control|Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
12032663|NCT00346320|Radiation|3-dimensional conformal radiation therapy|3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
12032664|NCT00346294|Drug|Etanercept|Intervention type was to study the drug delivery method.
12032665|NCT00346281|Device|32P BioSilicon|
12032666|NCT00346268|Drug|Morphine, Parecoxib|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
12032667|NCT00346268|Drug|Morphine, Placebo|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA
12032668|NCT00346255|Drug|BB-10901|dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.
12032669|NCT00346242|Drug|Zoledronic Acid|
12032670|NCT00346229|Biological|filgrastim|
12032671|NCT00346229|Biological|pegfilgrastim|
12032672|NCT00346229|Drug|lyso-thermosensitive liposomal doxorubicin(Thermodox)|
12032673|NCT00346229|Procedure|hyperthermia treatment|
12032674|NCT00346216|Drug|celecoxib|100 to 200 mg twice daily, taken by mouth
12032675|NCT00346216|Drug|Ibuprofen|ibuprofen 600 mg to 800 mg three times daily, taken by mouth
12032676|NCT00346216|Drug|Naproxen|naproxen 375mg to 500 mg twice daily, taken by mouth
12032677|NCT00346190|Drug|Alendronate|
12032678|NCT00346177|Biological|Autologous Stem Cells|Intramyocardial injections
12032679|NCT00346164|Drug|doxorubicin hydrochloride|Given IV
12032680|NCT00346164|Other|clinical observation|Patients undergo observation
12032681|NCT00346164|Procedure|therapeutic conventional surgery|Patients undergo surgery
12032682|NCT00346164|Radiation|3-dimensional conformal radiation therapy|Patients undergo radiotherapy
12032683|NCT00346164|Drug|ifosfamide|Given IV
12032684|NCT00346151|Drug|Belatacept|10 mg/kg given intravenously (IV) on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
12032685|NCT00346151|Drug|Sirolimus|4 mg/day (oral tablet) at transplant (day 1), then dose adjusted to maintain serum trough level of 8-12 ng/mL for at least 1 year
12032686|NCT00346151|Drug|Anti-thymocyte globulin|1.5 mg/kg given IV daily on days 1 through 4. Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.
12032687|NCT00346151|Drug|methylprednisolone|500 mg given IV at transplant (day 1), then given 250 mg IV on day 2 and given 0.5 mg/kg IV or prednisone 0.5 mg/kg given by mouth on days 3 and 4
12032688|NCT00346138|Procedure|Corneal transplantation|
12032689|NCT00346125|Biological|pegfilgrastim|will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
12032690|NCT00346125|Drug|doxorubicin hydrochloride|65 mg/m^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
12032691|NCT00346125|Drug|ifosfamide|9 g/m^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m^2 by continuous IV infusion over 7 days beginning on day 1
12032692|NCT00346125|Drug|pegylated liposomal doxorubicin hydrochloride|45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
12032693|NCT00346125|Procedure|conventional surgery|The surgical procedure will be decided by the treating physician and independent of study participation
12032694|NCT00346125|Radiation|fludeoxyglucose F 18|FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.
12032695|NCT00346112|Procedure|psycho-educational|
12032696|NCT00346099|Drug|Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by|
12032697|NCT00346099|Drug|Panitumumab with capecitabine and radiation|
12032698|NCT00346086|Drug|AIC (Amb a 1 Immunostimulatory Conjugate)|
12032699|NCT00346073|Biological|Boostrix™|Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
12032700|NCT00346073|Biological|ADACEL®|Sanofi Pasteur
12032701|NCT00346060|Device|Retinal transplantation instrument|
12032702|NCT00346060|Device|Fetal tissue.|
12032703|NCT00346047|Drug|Placebo|Corresponding placebo is applied for 12weeks
12032704|NCT00346047|Drug|Buprenorphine Transdermal System|Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks
12032705|NCT00346034|Drug|Pregabalin|150 to 600mg/day
12032706|NCT00346021|Behavioral|Increasing hat use|Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats
12032707|NCT00346008|Genetic|mutation analysis|
12032708|NCT00346008|Other|high performance liquid chromatography|
12032709|NCT00346008|Other|laboratory biomarker analysis|
12032710|NCT00346008|Other|questionnaire administration|
12032711|NCT00345982|Drug|Serdolect|16 mg, 12 weeks
12032712|NCT00345982|Drug|placebo|placebo
12032713|NCT00345969|Drug|Transdermal Testosterone gel (1%)|Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.
12032714|NCT00345969|Behavioral|Supervised exercise training|Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.
12032715|NCT00345956|Biological|Human rotavirus liquid vaccine|
12032716|NCT00345943|Other|MRI|Magnetic Resonance Imaging scans
12032717|NCT00345943|Behavioral|Neuropsychological Testing|Neuropsychological tests
12032718|NCT00345917|Device|Retinal transplantation instrument|
12032719|NCT00345917|Device|Fetal tissue.|
12032720|NCT00345904|Biological|Fluarix|
12032721|NCT00345891|Behavioral|Coping-focused counseling telephone calls|
12032722|NCT00345878|Biological|Placebo|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12032723|NCT00345878|Biological|HPV-16/18 L1 VLP AS04 (Cervarix TM)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12032724|NCT00345865|Drug|carmustine|Day -6, 300 mg/m^2 over 2 hour
12032725|NCT00345865|Drug|cyclophosphamide|"NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days.
~HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days.
~Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing."
12032726|NCT00345865|Drug|etoposide|"NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2.
~HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4."
12032727|NCT00345865|Procedure|peripheral blood stem cell transplantation|Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.
12032728|NCT00345865|Radiation|irradiation therapy|"Patients undergo total body irradiation (TBI) twice daily on days -4 to -1.
~> 1000 cGy to whole lung, kidney, or abdominal bath.
~> 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes.
~> 3600 cGy to whole brain."
12032729|NCT00345865|Biological|G-CSF|"Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size.
~Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days.
~If ANC falls <1000/μL, restart G-CSF."
12032730|NCT00345865|Drug|Cytarabine|100 mg/m^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.
12032731|NCT00345852|Procedure|Fetoscopic Selective Laser Photocoagulation|
12032732|NCT00345839|Drug|Cinacalcet|Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.
12032733|NCT00345839|Drug|Placebo|Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg QD, once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.
12032734|NCT00345826|Drug|dasatinib|
12032735|NCT00345813|Dietary Supplement|soy isoflavones|Given orally
12032736|NCT00345813|Dietary Supplement|soy protein isolate|Given orally
12032737|NCT00345813|Other|placebo|Given orally
12032738|NCT00345800|Drug|Sodium Oxybate (Xyrem)|Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral
12032739|NCT00345787|Drug|Placebo|Corresponding placebo is applied for 12weeks
12032740|NCT00345787|Drug|Buprenorphine Transdermal System|Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks
12032741|NCT00345774|Drug|PRX-08066|
12032742|NCT00345761|Drug|Bevacizumab|7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
12032743|NCT00345761|Drug|Oxaliplatin|130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
12032744|NCT00345761|Drug|Capecitabine|2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
12032745|NCT00345748|Drug|Abatacept|Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
12032746|NCT00345748|Drug|Placebo|Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
12032747|NCT00345735|Drug|Fentanyl|
12032748|NCT00345722|Procedure|strawberry dietary intervention|
12032749|NCT00345709|Behavioral|Questionnaire|65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors.
12032750|NCT00345696|Drug|Bevacizumab|5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.
12032751|NCT00345696|Drug|Capecitabine|600 mg/m2, orally, every 12 hours, continuous.
12032752|NCT00345696|Drug|Oxaliplatine|85 mg/m2, intravenous, 2 hours infusion, every 2 weeks
12032753|NCT00345683|Biological|GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)|Booster dose by intramuscular injection
12032754|NCT00345683|Biological|PedvaxHIB|Booster dose by intramuscular injection
12032755|NCT00345683|Biological|Prevnar|Booster dose by intramuscular injection
12032756|NCT00345683|Biological|M-M-R II|Single dose by subcutaneous injection
12032757|NCT00345683|Biological|Varivax|Single dose by subcutaneous injection
12032758|NCT00345670|Biological|MEDI-534|10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
12032759|NCT00345670|Biological|MEDI-534|10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
12032760|NCT00345670|Biological|MEDI-534|10:6 TCID50 of MEDI-534; intranasal spray
12032761|NCT00345657|Drug|Niacin Extended Release/Lovastatin|
12032762|NCT00345644|Drug|risedronate|risedronate sodium 35 mg tablets (once a week dose)
12032763|NCT00345644|Drug|risedronate placebo|placebo for risedronate tablets (once a week dose)
12032764|NCT00345631|Other|Manual Compression|Manual compression
12032765|NCT00345631|Device|Vascular Closure Device|Investigational vascular closure device
12032766|NCT00345618|Drug|Idrabiotaparinux sodium|"0.5 mL pre-filled syringe for 3.0 mg
~Subcutaneous injection"
12032767|NCT00345618|Drug|Warfarin|"Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
~Oral administration"
12032768|NCT00345618|Drug|Placebo (for idrabiotaparinux sodium)|"0.5 mL pre-filled syringe
~Subcutaneous injection"
12032769|NCT00345618|Drug|Avidin|"100 mg in 10 mg/mL solution
~Intravenous infusion for 30 minutes"
12032770|NCT00345618|Drug|Placebo (for warfarin)|"Warfarin matching capsules
~Oral administration"
12032771|NCT00345618|Drug|Enoxaparin|"Prefilled syringes as locally registered
~Subcutaneous injection"
12032772|NCT00345605|Drug|Sodium Phenylbutyrate|None will be administered during the washout period; 500 mg/kg/day or 10 grams/m2 will be administered during the first one week treatment period in addition to arginine
12032773|NCT00345605|Drug|Arginine|Standard therapeutic dose of 500 mg/kg/day or 10 grams/2 will be administered during the washout periods, during the first one week treatment period when receiving arginine plus Buphenyl, 100 mg/kg/day or 2 grams/m2 will be administered, during the second treatment week, when receiving arginine alone, 500 mg/kg/day or 10 grams/m2 will be administered
12032774|NCT00345592|Device|Dual (atrial and ventricular) implantable defibrillator|The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
12032775|NCT00345592|Device|Dual (atrial and ventricular) implantable defibrillator|In hospital application of anti arrhythmic therapies via the device
12032776|NCT00345592|Device|Dual (atrial and ventricular) implantable defibrillator|Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
12032777|NCT00345579|Biological|GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014|3-dose intramuscular injection
12032778|NCT00345579|Biological|ActHIB|3-dose intramuscular injection
12032779|NCT00345579|Biological|Pediarix/Infanrix Penta|3-dose intramuscular injection
12032780|NCT00345566|Procedure|Nutrition composition|
12032781|NCT00345540|Drug|NOV-002|60 mg / mL / day / 20-23 Days
12032782|NCT00345540|Drug|Carboplatin|AUC 5 following IV bolus administration of NOV-002
12032783|NCT00345527|Behavioral|Emotion and Behaviour Regulation Treatment (EBRT)|
12032784|NCT00345527|Behavioral|Cognitive Behavioural Therapy|
12032785|NCT00345514|Behavioral|Behavioral Intervention Arm|The arm emphasized individual provider behavior (interactive CME, feedback at the provider, clinic and program levels, expert modeling, academic detailing and opinion leaders)
12032786|NCT00345514|Behavioral|Organizational Interventions Arm|Leadership, team building, benchmarking at the clinic and program level
12032787|NCT00345501|Drug|Iloprost|Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end
12032788|NCT00345501|Drug|Placebo|Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end
12032789|NCT00345462|Biological|Trivalent virosomal influenza vaccine|
12032790|NCT00345449|Behavioral|Decision Aid|
12032791|NCT00345410|Drug|AVE1625 B|
12032792|NCT00345397|Device|Percutaneous endoscopic colostomy (PEC) tube|PEC placement for antegrade enemas uses commercially available PEG tubes
12032793|NCT00345384|Drug|Dexmedetomidine|Dexmedetomidine titrated over 24 hours
12032794|NCT00345384|Other|Placebo (Normal Saline)|
12032795|NCT00345371|Drug|Topiramate|
12032796|NCT00345371|Drug|Placebo Oral Tablet|
12032797|NCT00345358|Biological|Synflorix|1, 2, 3 or 4 Intramuscular injections, depending on age group
12032798|NCT00345358|Biological|Infanrix IPV/Hib|4 intramuscular injections
12032799|NCT00345345|Biological|Alemtuzumab (Campath)|Alemtuzumab (Campath) will be administered at 10 mg/dose IV for 10 days as an infusion over 2 hours.
12032800|NCT00345332|Drug|Botox|Injected
12032801|NCT00345332|Drug|Placebo|Injected
12032802|NCT00345319|Biological|rabies vaccine|Administration of PCECV according to ESSEN regimen
12032803|NCT00345306|Drug|Comparison between two different progesterone administration|
12032804|NCT00345293|Biological|autologous dendritic cell vaccine (DC/PC3)|ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
12032805|NCT00345280|Procedure|impression cytology, obtain the tear fluid|Vitamin A
12032806|NCT00345267|Device|Integrated Care Pathway|
12032807|NCT00345254|Procedure|severing cord|The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
12032808|NCT00345241|Drug|Systane Ocular Drops (OTC)|
12032809|NCT00345241|Drug|Placebo - Saline Drops|
12032810|NCT00345215|Behavioral|High Sodium Diet|250-350 mmol
12032811|NCT00345215|Behavioral|Low Sodium Diet|25-35 mmol
12032812|NCT00345202|Drug|HMG-CoA reductase inhibition (atorvastatin)|
12032813|NCT00345189|Drug|CNF2024|"CNF2024 capsules administered orally following 2 schedules:
~starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or
~starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).
~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment."
12032814|NCT00345176|Dietary Supplement|Lutein/zeaxanthin|10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)
12032815|NCT00345176|Dietary Supplement|DHA/EPA|Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
12032816|NCT00345176|Drug|Lutein/zeaxanthin and DHA/EPA|10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
12032817|NCT00345163|Drug|bevacizumab|Intravenous repeating dose
12032818|NCT00345163|Drug|irinotecan|Intravenous repeating dose
12032819|NCT00345150|Drug|Ng-monomethyl-L-arginine (drug)|
12032820|NCT00345137|Drug|Ng-monomethyl-L-arginine (drug)|
12032821|NCT00345124|Behavioral|high sodium diet|250-350 mmol
12032822|NCT00345124|Behavioral|Low Sodium Diet|25-35 mmol
12032823|NCT00345111|Procedure|Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens.|
12032825|NCT00345085|Device|Wavefront and Contrast Sensitivity|
12032826|NCT00345072|Device|Web-based decision aid system|
12032827|NCT00345059|Drug|docetaxel|
12032828|NCT00345059|Drug|vinorelbine|
12032829|NCT00345059|Drug|gemcitabine|
12032830|NCT00345059|Drug|capecitabine|
12032831|NCT00345046|Drug|Pred Forte|Four drops daily decreasing to once daily over four weeks.
12032832|NCT00345046|Drug|EconoPred Plus|Prednisolone Acetate four times daily decreasing to once daily over four weeks.
12032833|NCT00345046|Drug|Prednisolone Acetate|Dosed four times daily decreasing to once daily over four weeks.
12032834|NCT00345033|Drug|Aripiprazole|15-mg dose once a day for 8 weeks
12032835|NCT00345033|Drug|Placebo|1 tablet placebo dose once a day for 8 weeks
12032836|NCT00345020|Procedure|Deep Lamellar Endothelial Keratoplasty: Small Incision Technique|
12032837|NCT00345007|Procedure|Scleral buckling|
12032838|NCT00344994|Drug|pramipexole|PO, 0.25mg, 0.50mg, or 0.75mg QHS
12032839|NCT00344981|Drug|Tenofovir|Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir.
12032840|NCT00344981|Drug|Hydroxyurea|Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir. Volunteers will continue on this regimen for 48 weeks. Patients will be monitored for immunological and virological parameters as well as the incidence of toxicity and side effects during the study. If a patient's viral load reaches >400 copies/ml on 3 consecutive measurements over a 6 week period, they will be terminated from the study and started back on their HAART.
12032841|NCT00344968|Drug|fluocinolone acetonide|0.5 mg fluocinolone acetonide intravitreal insert
12032842|NCT00344968|Drug|Fluocinolone Acetonide|0.2 mg fluocinolone acetonide intravitreal insert
12032843|NCT00344968|Procedure|Standard of care laser photocoagulation|Laser photocoagulation
12032844|NCT00344955|Drug|HMG-CoA reductase inhibition (atorvastatin)|
12032845|NCT00344942|Drug|triamcinolone acetonide|220µg/day or a double spray into each nostril once daily for 12 weeks'treatment
12032846|NCT00344942|Drug|placebo|a double spray into each nostril once daily
12032847|NCT00344916|Drug|Ng-monomethyl-L-arginine (drug)|
12032848|NCT00344890|Procedure|Anterior Cervical Discectomy and Fusion|1,2,3,or 4 level surgery
12032849|NCT00344864|Device|LADARWave|
12032850|NCT00344851|Drug|metformin, exenatide or combined (metformin & exenatide )|
12032851|NCT00344838|Device|Comparison of LADAR CustomLasik and VISX Wavefront System custom laser ablation devices|
12032852|NCT00344825|Drug|Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)|"Descriptive statistical methods applied for the whole study cohort and for subgroups according to QoL and the correlation of the following parameters: Age, Sex, Stage of disease, Time from first B-CLL diagnosis, number of previous B-CLL treatments, Reason of starting of the new B-CLL treatment (progression disease, relapse, no-response to the previous treatment, previous treatment toxicity), Therapeutic Regimen (Day Hospital, Hospital Admission, etc.), Type of Centre, B-CLL treatment lasting, Response to B-CLL treatment.
~QoL at baseline, Change in QoL over time evaluated using an analysis of Variance."
12032853|NCT00344812|Drug|LAAM. buprenorphine and methadone|
12032854|NCT00344786|Drug|CNF2024 (BIIB021)|"Dose starting at 12.5 mg/d, p.o. as a once-daily dose for 21 days followed by a 1-week rest period.
~Dose escalation will proceed according to the predetermined scheme until the maximum tolerated dose (MTD) is reached due to dose limiting toxicities (DLT) during the first course of treatment."
12032855|NCT00344773|Drug|Gefitinib|250mg tablet oral tablet once daily
12032856|NCT00344760|Drug|Enfuvirtide|subcutaneously twice a day
12032857|NCT00344760|Drug|Efavirenz, lamivudine, and tenofovir|Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily
12032858|NCT00344747|Behavioral|dietary, behavioral, physical activity|
12032859|NCT00344734|Drug|Ng-monomethyl-L-arginine (drug)|
12032860|NCT00344721|Dietary Supplement|Omega-3 fatty acid supplement|Participants receive four oral doses of soft-gel capsules to be taken daily (QD) for 3 months.
12032861|NCT00344721|Dietary Supplement|Placebo|Participants receive four oral doses of soft-gel capsules containing wheat germ oil to be taken daily for 3 months.
12032862|NCT00344708|Procedure|Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells|
12032863|NCT00344695|Drug|bupropion SR|
12032864|NCT00344682|Drug|memantine|memantine 5mg - 20mg PO daily
12032865|NCT00344682|Drug|Placebo|5mg - 20mg PO daily over 8 weeks
12032866|NCT00344669|Drug|Albendazole 400 mg, given 6 monthly|
12032867|NCT00344643|Device|Silicone Hydrogel Soft Contact Lenses|
12032868|NCT00344630|Device|TAXUS Stent and Cypher Stent|
12032869|NCT00344617|Drug|Bevacizumab (tradename: Avastin)|
12032870|NCT00344604|Behavioral|Role of psychosocial and quality of life parameters prior to and following LASIK.|
12032871|NCT00344591|Behavioral|Structured Ecosystems Therapy (SET)|
12032872|NCT00344591|Behavioral|Individually tailored intervention|
12032873|NCT00344578|Device|Restor IOL|
12032874|NCT00344565|Drug|Modafinil|During the first lead-in week, participants will attend the clinic 3 times per week, participate in one session of neuropsychological assessment and receive motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP). At the end of the first lead-in week participants will be randomized to modafinil or placebo stratified by the levels of cocaine use, and whether or not abstinence was achieved. Participants will then be followed for 11 weeks with measures of cocaine cravings and withdrawal, and drug use outcome, and will receive CBT-RP.
12032875|NCT00344565|Behavioral|Cognitive Behavioral Therapy--Relapse Prevention|Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)
12032876|NCT00344552|Drug|Paclitaxel|Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over
12032920|NCT00344019|Drug|Placebo Oral Tablet|placebo pre-PCI for ACS
12032921|NCT00344019|Drug|Atorvastatin 80mg|atorvastatin 80 mg pre-angio/PCI
12032877|NCT00344539|Biological|AMA1-C1/Alhydrogel®|AMA1-C1/Alhydrogel malaria vaccine, cloudy suspension, 0.5 mL dose containing up to equivalent of 377 mcg of aluminum as Alhydrogel® (800 mcg of aluminum hydroxide gel per dose) onto which 20 mcg or 80 mcg of recombinant AMA1-C1 is bound. Dosages: 20 mcg and 80 mcg administered via the deltoid muscle by IM injection
12032878|NCT00344539|Biological|CPG 7909 Oligodeoxynucleotide (VaxImmune®)|CPG 7909 is an investigational agent and is supplied in sterile vials at 10mg/mL in phosphate buffered saline for intramuscular administration. Dosage 500 mcg.
12032879|NCT00344526|Drug|Melphalan|
12032880|NCT00344526|Drug|Dexamethasone|
12032881|NCT00344526|Procedure|Autologous stem cell transplantation|
12032882|NCT00344513|Drug|Beta-blockers including Carvedilol|
12032883|NCT00344513|Drug|ACE inhibitors|
12032884|NCT00344500|Behavioral|Behavioral Weight Loss Program|"Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient
~Be given a 7% weight loss goal
~Be assisted in obtaining a 500 calorie reduction per day
~Exercise for at least 30 min/day, at least 5 days a week
~Maintain weekly food and exercise diaries
~Be quizzed on their knowledge of healthy eating habits and nutrition"
12032885|NCT00344487|Drug|Lopinavir/Ritonavir|Dosing of Kaletra will be per package insert and BID with food. A three-drug standard of care antiretroviral regimen will be used in this study. Subjects will enter the study already on an effective, virally-suppressive treatment regimen. One of these drugs will be substituted for Lopinavir/ritonavir (Kaletra®). However, the nucleoside/nucleotide backbone drugs that the subject is already on will remain the same.
12032886|NCT00344474|Behavioral|PRE-Venture: Personality Risk Education|Motivational and Cognitive-Behavioural interventions targeting four personality risk factors for substance misuse. Two, 90-minute group sessions conducted at school with personality-matched peers and trained psychologists/councellors and co-facilitators.
12032887|NCT00344461|Drug|Nevirapine, FTC, and Tenofovir|One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
12032888|NCT00344448|Drug|Raptiva|During the first phase of the study, subjects are randomized in a double blind fashion to receive weekly subcutaneous injections of efalizumab (Raptiva) or placebo (weeks 0-12). The second 12 weeks long phase is open label with all subjects receiving weekly subcutaneous injections of efalizumab.
12032889|NCT00344422|Drug|Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)|
12032890|NCT00344409|Drug|darbepoetin alfa|
12032891|NCT00344383|Drug|Norgestimate/Ethinyl Estradiol tablet|
12032892|NCT00344370|Drug|Pitavastatin|Pitavastatin 4 mg QD
12032893|NCT00344370|Drug|Atorvastatin|Atorvastatin 40 mg
12032894|NCT00344318|Biological|Pneumococcal conjugate vaccine GSK1024850A|3 Intramuscular injections.
12032895|NCT00344318|Biological|Prevenar|3 Intramuscular injections
12032896|NCT00344318|Biological|Tritanrix-HepB|3 Intramuscular injections
12032897|NCT00344318|Biological|Hiberix|Reconstituted with Tritanrix before injection
12032898|NCT00344318|Biological|Polio Sabin.|3 oral doses.
12032899|NCT00344318|Biological|Poliorix.|3 intramuscular injections
12032900|NCT00344305|Biological|Trivalent influenza virus vaccine live, intranasal|A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains.
12032901|NCT00344253|Drug|Interferon beta|
12032902|NCT00344253|Drug|Methotrexate|
12032903|NCT00344240|Behavioral|Functional circuit training with lifestyle behavior|
12032904|NCT00344227|Drug|Lucentis (Ranibizumab)|
12032905|NCT00344214|Behavioral|Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program|This condition is a Theory-Based Counseling Program. The program will involve nine 90-minute face-to-face counseling sessions that use CBT and strategies associated with social cognitive theory. The theory addresses three treatment domains, including mood regulation, reduction/cessation of meth use, and reduction of high risk sexual practices.
12032906|NCT00344214|Behavioral|Standard care|Standard care involves nine weekly, face-to-face individual counseling sessions that provide standard care in relation to sexual risk, methamphetamine use, and depression. The sexual risk component is a modified version of Project RESPECT 1 (CDC, Atlanta) that focuses on educational materials and personal risk appraisal. The meth component is a modified version of the 12-step drug abstinence program developed by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) (Project MATCH). The depression component is an educational approach based primarily on materials provided by the National Alliance on Mental Illness (NAMI) and the National Institute of Mental Health (NIMH).
12032907|NCT00344201|Device|Tisseel fibrin adhesive|Intraoperative application to scleral bed and graft
12032908|NCT00344175|Drug|pitavastatin|
12032909|NCT00344175|Drug|simvastatin|
12032910|NCT00344149|Drug|Rituximab (Mabthera)|I.V infusion of Rituximab 375 mg/m2 per week for 4 weeks
12032911|NCT00344123|Drug|Tipranavir/Ritonavir|"On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
~On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r."
12032912|NCT00344123|Drug|Rosuvastatin|"On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
~On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r.."
12032913|NCT00344110|Drug|Aliskiren|
12032914|NCT00344097|Procedure|Soy protein|
12032915|NCT00344058|Drug|abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)|
12032916|NCT00344045|Drug|Paracetamol|IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
12032917|NCT00344045|Drug|Placebo|IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours
12032918|NCT00344032|Biological|Placebo|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12032919|NCT00344032|Biological|HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12032922|NCT00344019|Other|Screening|Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)
12032923|NCT00344006|Drug|chlorproguanil-dapsone-artesunate|
12032924|NCT00344006|Drug|artemether-lumefantrine|
12032925|NCT00343993|Device|noninvasive positive pressure ventilation|
12032926|NCT00343980|Drug|rosiglitazone|Tablets, 4 mg once or twice a day.
12032927|NCT00343980|Drug|inhaled human insulin|Treat-to-target dose titration scheme, pre-prandial, inhalation.
12032928|NCT00343980|Drug|glimepiride|Tablets, 4 mg/day.
12032929|NCT00343954|Drug|L-citrulline tablets, 1000 mg|
12032930|NCT00343941|Drug|Tucaresol tablets 25 mg|
12032931|NCT00343928|Other|Branched-chain amino acids|Participants will spend approximately 2 weeks in each phase over a 9-week period, during which they will receive an amino acid mixture and the placebo control condition.
12032932|NCT00343915|Biological|Engerix™-B (thiomersal-free) 20µg|In the primary study: 2 deep intramuscular injections (Months 0, & 6)
12032933|NCT00343915|Biological|10 μg Engerix™-B (preservative-free)|In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)
12032934|NCT00343915|Biological|placebo|In the primary study: 1 deep intramuscular injection (month 1)
12032935|NCT00343902|Drug|Crataegus Special Extract WS 1442|
12032936|NCT00343889|Biological|DTaP-HB-PRP~T vaccine + OPV|0.5 mL, Intramuscular
12032937|NCT00343889|Biological|Tritanrix-HepB/Hib™ + OPV vaccine|0.5 mL, Intramuscular
12032938|NCT00343889|Biological|Oral Polio Vaccine|Oral co-administered with study vaccine
12032939|NCT00343876|Drug|aspirin|
12032940|NCT00343876|Drug|clopidogrel|
12032941|NCT00343863|Drug|palonosetron hydrochloride|Given IV
12032942|NCT00343863|Drug|cyclophosphamide|Given orally
12032943|NCT00343863|Drug|dexamethasone|Given orally or IV
12032944|NCT00343863|Drug|doxorubicin hydrochloride|Given IV
12032945|NCT00343863|Procedure|quality-of-life assessment|Ancillary studies
12032946|NCT00343863|Procedure|nausea and vomiting therapy|Given IV
12032947|NCT00343863|Procedure|management of therapy complications|Given IV
12032948|NCT00343863|Drug|ondansetron hydrochloride|Given IV
12032949|NCT00343863|Other|survey administration|Ancillary studies
12032950|NCT00343850|Drug|Asacol (mesalamine)|
12032951|NCT00343824|Procedure|aquacel AG hydrofiber versus acticoat burn dressing|Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
12032952|NCT00343811|Drug|Modafinil|
12032953|NCT00343798|Drug|cyclophosphamide|Given IV
12032954|NCT00343798|Drug|fludarabine phosphate|Given IV
12032955|NCT00343798|Drug|cyclosporine|Given IV
12032956|NCT00343798|Drug|mycophenolate mofetil|Given IV or PO
12032957|NCT00343798|Other|ex-vivo umbilical cord blood expansion|Undergo double-unit umbilical cord blood transplantation
12032958|NCT00343798|Procedure|double-unit umbilical cord blood transplantation|Undergo double-unit umbilical cord blood transplantation
12032959|NCT00343798|Procedure|biopsy|Optional correlative studies
12032960|NCT00343798|Other|immunologic technique|Correlative studies
12032961|NCT00343798|Other|diagnostic laboratory biomarker analysis|Correlative studies
12032962|NCT00343785|Drug|cyclophosphamide|Given IV
12032963|NCT00343785|Biological|anti-thymocyte globulin|Given IV
12032964|NCT00343785|Drug|cyclosporine|Given IV or PO
12032965|NCT00343785|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow transplantation
12032966|NCT00343785|Drug|methotrexate|Given IV
12032967|NCT00343785|Genetic|DNA analysis|Correlative studies
12032968|NCT00343785|Other|flow cytometry|Correlative studies
12032969|NCT00343785|Genetic|polymorphism analysis|Correlative studies
12032970|NCT00343785|Other|laboratory biomarker analysis|Correlative studies
12032971|NCT00343759|Drug|Lapatinib|Patients will take 14 days of Lapatinib prior to definitive surgery.
12032972|NCT00343733|Drug|OraVescent Fentanyl|
12032973|NCT00343720|Drug|VELCADE|
12032974|NCT00343720|Drug|Alimta|
12032975|NCT00343707|Drug|vestipitant|
12032976|NCT00343707|Drug|paroxetine|
12032977|NCT00343681|Biological|Inactivated influenza vaccine (split virion)|0.5 mL, Intramuscular
12032978|NCT00343668|Drug|S-1, irinotecan|S-1, 40 mg/m2 PO twice daily, days 1-14 irinotecan, 150 mg/m2 IV, day 1
12032979|NCT00343655|Drug|Atorvastatin|
12032980|NCT00343642|Dietary Supplement|Time and attention + fructo-oligosaccharide placebo|2 teaspoons of placebo powder daily
12032981|NCT00343642|Dietary Supplement|dietary therapy + fructo-oligosaccharide placebo|Medical nutrition therapy and 2 teaspoons of placebo powder
12032982|NCT00343642|Drug|Time and attention + active fructooligosaccharide supplementation|2 teaspoons of fructooligosaccharides daily
12032983|NCT00343629|Drug|sulindac|
12032984|NCT00343629|Other|pharmacological study|
12032985|NCT00343616|Procedure|cognitive assessment|Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
12032986|NCT00343616|Procedure|fatigue assessment and management|Fatigue will be evaluated using the Brief Fatigue Inventory.
12032987|NCT00343616|Procedure|psychologic distress|Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
12032988|NCT00343616|Procedure|quality-of-life assessment|Quality of life will be assessed using global linear analogue self-assessment (LASA) indicators for physical well-being, mood, coping effort (PACIS), perceived social support and subjective health estimation.
12032989|NCT00343590|Device|Whole Body Vibration machine|
12032990|NCT00343564|Drug|SB-743921|Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops.
12032991|NCT00343564|Drug|SB-743921|Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.
12032992|NCT00343551|Drug|Aliskiren|
12032993|NCT00343525|Drug|bavituximab|
12032994|NCT00343512|Drug|docetaxel|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
12032995|NCT00343512|Genetic|protein expression analysis|protein expression analysis
12032996|NCT00343512|Other|laboratory biomarker analysis|laboratory biomarker analysis
12032997|NCT00343512|Procedure|biopsy|biopsy
12032998|NCT00343512|Procedure|conventional surgery|conventional surgery
12032999|NCT00343512|Procedure|neoadjuvant therapy|neoadjuvant therapy
12033000|NCT00343499|Drug|valsartan|
12033001|NCT00343486|Drug|Solabegron|
12033002|NCT00343460|Drug|APF530|Given subcutanously
12033003|NCT00343460|Drug|dexamethasone|Given IV and orally
12033004|NCT00343460|Drug|Palonosetron Hydrochloride|Given IV
12033005|NCT00343460|Other|placebo|Given subcutanously or IV
12033006|NCT00343447|Biological|autologous tumor cell vaccine|
12033007|NCT00343447|Biological|rituximab|
12033008|NCT00343447|Drug|cyclophosphamide|
12033009|NCT00343434|Behavioral|behavioral dietary intervention|
12033010|NCT00343434|Behavioral|exercise intervention|
12033011|NCT00343434|Dietary Supplement|soy isoflavones|
12033012|NCT00343434|Dietary Supplement|soy protein isolate|
12033013|NCT00343434|Other|counseling intervention|
12033014|NCT00343434|Other|educational intervention|
12033015|NCT00343434|Procedure|psychosocial assessment and care|
12033016|NCT00343434|Procedure|quality-of-life assessment|
12033017|NCT00343421|Biological|PEDIACEL® and Prevenar®|0.5 mL each, IM (opposite thigh)
12033018|NCT00343421|Biological|Infanrix®-IPV+Hib and Prevenar®|0.5 mL each, IM (opposite thigh)
12033019|NCT00343408|Drug|cediranib maleate|
12033020|NCT00343408|Drug|cisplatin|
12033021|NCT00343408|Drug|fluorouracil|
12033022|NCT00343408|Drug|gemcitabine hydrochloride|
12033023|NCT00343408|Drug|leucovorin calcium|
12033024|NCT00343408|Drug|oxaliplatin|
12033025|NCT00343395|Drug|AVANDAMET|2/500 mg
12033026|NCT00343382|Drug|pilocarpine hydrochloride|Given orally
12033027|NCT00343382|Other|placebo|Given orally
12033028|NCT00343369|Drug|asparaginase|
12033029|NCT00343369|Drug|cyclophosphamide|
12033030|NCT00343369|Drug|cytarabine|
12033031|NCT00343369|Drug|daunorubicin hydrochloride|
12033032|NCT00343369|Drug|dexamethasone|
12033033|NCT00343369|Drug|doxorubicin hydrochloride|
12033034|NCT00343369|Drug|mercaptopurine|
12033035|NCT00343369|Drug|methotrexate|
12033036|NCT00343369|Drug|pegaspargase|
12033037|NCT00343369|Drug|prednisolone|
12033038|NCT00343369|Drug|teniposide|
12033039|NCT00343369|Drug|thioguanine|
12033040|NCT00343369|Drug|vincristine sulfate|
12033041|NCT00343369|Radiation|radiation therapy|
12033042|NCT00343356|Drug|Trement|
12033043|NCT00343343|Device|NovoFine® needle 6 mm|
12033044|NCT00343343|Device|NovoFine® needle 4 mm|
12033045|NCT00343317|Drug|Intrapartum Cefoxitin (2g) vs. placebo|
12033046|NCT00343304|Device|Robot|
12033047|NCT00343304|Device|Ergometer|
12033048|NCT00343291|Biological|Cetuximab|Administered intravenously
12033049|NCT00343291|Biological|Bevacizumab|Administered intravenously
12033050|NCT00343291|Drug|Paclitaxel|Administered intravenously
12033051|NCT00343291|Drug|Carboplatin|Administered intravenously
12033052|NCT00343278|Drug|Valaciclovir Hydrochloride|
12033053|NCT00343265|Drug|Vaginal progesterone gel|Vaginal gel once daily
12033054|NCT00343265|Drug|Placebo gel|once daily
12033055|NCT00343252|Drug|teriparatide|20 ug/day, subcutaneous, 18 months
12033056|NCT00343252|Drug|risedronate|35 mg/once weekly, oral, 18 months
12033057|NCT00343252|Drug|placebo|once weekly, oral, 18 months
12033058|NCT00343252|Drug|placebo|daily, subcutaneous, 18 months
12033059|NCT00343239|Drug|Docetaxel|"Formulation: infusion solution
~Route of administration: IV infusion on the first day of each 21-day cycle
~Dose regimen: 75 mg/m2"
12033060|NCT00343239|Drug|Cisplatin|"Formulation: infusion solution
~Route of administration: IV infusion on the first day of each 21-day cycle
~Dose regimen: 75 mg/m2"
12033061|NCT00343239|Drug|Fluorouracil|"Formulation: infusion solution
~Route of administration: IV infusion on the first day of each 21-day cycle
~Dose regimen: 750 mg/m2/day for 5 days"
12033062|NCT00343226|Drug|Basiliximab|
12033063|NCT00343213|Procedure|colposcopy|
12033064|NCT00343200|Drug|Placebo|Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
12033065|NCT00343200|Drug|Viagra (sildenafil citrate)|Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
12033066|NCT00343187|Drug|ACZONE (dapsone) Gel, 5%|
12033067|NCT00343187|Drug|Vehicle Control|
12033068|NCT00343174|Drug|Ancrod|
12033069|NCT00343161|Drug|esomeprazole|
12033070|NCT00343161|Drug|Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)|
12033071|NCT00343148|Drug|AVI-4126 Injection (RESTEN-NG®)|
12033072|NCT00343135|Drug|amoxicillin/clavulanate potassium 1gm|amoxicillin/clavulanate potassium 1gm
12033073|NCT00343122|Procedure|echocardiography for intrapulmonary vasodilatation|
12033074|NCT00343109|Biological|HER-2/neu intracellular domain protein|Given ID
12033075|NCT00343109|Procedure|leukapheresis|Optional correlative studies
12033076|NCT00343109|Other|laboratory biomarker analysis|Correlative studies
12033077|NCT00343109|Biological|sargramostim|Given ID
12033078|NCT00343109|Other|immunologic technique|Correlative studies
12033079|NCT00343109|Biological|synthetic tumor-associated peptide vaccine therapy|Given ID
12033080|NCT00343096|Drug|Lorazepam|All doses 0.1mg/kg once, repeat after 10 minutes x1
12033136|NCT00340379|Drug|Sertraline|Target dosage 150-200mg/day based on tolerance.
12033081|NCT00343083|Drug|Erbitux, Paclitaxel & Carboplatin|"Paclitaxel, 40 mg/m2/week,
~1-hour infusion (weeks 2-9.Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose.
~Cetuximab: 400 mg/m2 IV (initial dose) week 1 then 250 mg/m2 IV weekly for 8 weeks weeks 2-9). Cetuximab will be administered 400mg/m2 IV on Day 1, then the first 250 mg/m2 IV dose will be given on day 8 (week 2) prior to carboplatin dose.
~Carboplatin, AUC=2/week as a 30 minute infusion after cetuximab infusion (weeks 2-9)Carboplatin will be administered at a dose of AUC = 2/week IV bolus each week and will be administered prior to head and neck irradiation dose. (Carboplatin: AUC=2/week x 8 weeks (weeks 2-9)"
12033082|NCT00343083|Radiation|Radiation|XRT=Radiotherapy 1.8 Gy radiation/day, 5 days a week for a total of 70.2 Gy.(weeks 2-9) - IMRT is allowed
12033083|NCT00343070|Drug|Oral administration of escitalopram during 8 weeks|
12033084|NCT00343057|Other|Patients' questionnaire|
12033085|NCT00343044|Drug|Topotecan|Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
12033086|NCT00343044|Drug|Bevacizumab|bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
12033087|NCT00343005|Biological|AMA1-C1|
12033088|NCT00343005|Drug|AMA1-C1/alhydrogel Malaria Vaccine|
12033089|NCT00342940|Biological|influenza surface antigen inactivated vaccine|
12033090|NCT00342862|Drug|Amevive exposure|Observational
12033091|NCT00342849|Drug|Succimer|Succimer (2,3-meso-dimercaptosuccinic acid) is an orally active dithiol compound that is a relatively specific chelating agent for heavy metals, especially lead, arsenic and mercury. The drug undergoes limited absorption in the gastrointestinal tract and then is rapidly metabolized to mixed disulfides which are eliminated in the urine. Blood levels decline slowly with an apparent elimination half-life of about 48 hours in adults.
12033092|NCT00342849|Drug|Placebo|
12033093|NCT00342836|Procedure|Akt levels|
12033094|NCT00342706|Procedure|Community based intervention|
12033095|NCT00342628|Biological|Vi-rEPA conjugate vaccine for typhoid fever|Vi-rEPA contains a 25 ug/dose of Vi (Sanofi-Pasteur Lot 130) and rEPA in 0.2 N NaCl, 10 mM phosphate PH 7.2 and 0.01% thimerosal.
12033096|NCT00342628|Biological|Hib-TT|Hib-TT is Hemophilus influenzae type b-tetanus toxoid conjugate vaccine (ActHib, NDC#49281-545-05 Sanofi-Pasteur, France) in single-dose vials containing 10 ugof Hib CP conjugated to 24 ug of tetanus toxoid
12033097|NCT00342628|Biological|DTP|DTP, diphtheria, tetanus toxoid and pertussis vaccine were from the Ministry of Health, Vietnam for routine infant immunization
12033098|NCT00342563|Drug|mecamylamine|mecamylamine 10mg/day
12033099|NCT00342563|Drug|Placebo|Placebo
12033100|NCT00342381|Drug|3,4-diaminopyridine|Single dose 3,4 diaminopyridine
12033101|NCT00342381|Drug|Placebo|Single dose placebo treatment
12033102|NCT00342368|Procedure|CPAP delivered by an Helmet|continuous positive airway pressures delivered through an helmet
12033103|NCT00342355|Drug|Zidovudine|600 mg once daily
12033104|NCT00342355|Drug|Stavudine|40 mg once daily
12033105|NCT00342355|Drug|Didanosine|<60 kg/125 mg twice daily or >60kg/200 mg twice daily
12033106|NCT00342355|Drug|Lamivudine|300 mg once daily
12033107|NCT00342355|Drug|Efavirenz|600 mg once daily
12033108|NCT00342355|Drug|Lopinavir/Ritonavir|r/LPV 400mg/100mg twice daily
12033109|NCT00342316|Procedure|Reduced Intensity Conditioning Stem Cell Transplantation|"One of the following conditioning regimens:
~Busulphan (orally or IV), fludarabine
~Fludarabine, carmustine, melfalan
~Cyclophosphamide, fludarabine"
12033110|NCT00342134|Procedure|Stem Cell Transplanataion|
12033111|NCT00342108|Behavioral|cross-modal sensory stimulation|comparison of participant response to unimodal visual stimulation and to bimodal sensory stimulation
12033112|NCT00341640|Procedure|Blood testing|
12033113|NCT00341614|Behavioral|3-month Exercise Training and Diet Education|
12033114|NCT00341471|Procedure|Risk Behavior Prevention Intervention Program|
12033115|NCT00341445|Behavioral|Effect of Cockroach Allergen|
12033116|NCT00341432|Behavioral|Nicotine Replacement Therapy|
12033117|NCT00341354|Behavioral|Prolonged Mechanical Ventilation|
12033118|NCT00341328|Biological|Intradermal injection of Mycobacterium w|Mw Vaccine is given as intradermal administration. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks
12033119|NCT00341250|Drug|AMA1-C1/Alhydrogel Malaria Vaccine|
12033120|NCT00341224|Behavioral|Group-mentoring intervention|Group mentoring used to teach social skills to middle school students
12033121|NCT00341055|Drug|Epoetin alfa|
12033122|NCT00340938|Procedure|Blood testing|
12033123|NCT00340834|Drug|Fingolimod 1.25 mg|"Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
~Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment."
12033124|NCT00340834|Drug|Fingolimod 0.5 mg|"Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
~Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily."
12033125|NCT00340834|Drug|Interferon β-1a 30 µg|"Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
~Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment."
12033126|NCT00340704|Drug|tamsulosin hydrochloride|oral
12033127|NCT00340691|Drug|Doxycycline|
12033128|NCT00340678|Drug|Losartan|Treatment with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
12033129|NCT00340678|Drug|Placebo|Treatment with placebo corresponding to each dose of losartan.
12033130|NCT00340613|Drug|glargine insulin|
12033131|NCT00340574|Drug|AMA1-C1/Alhydrogel + CpG 7909|
12033132|NCT00340483|Behavioral|Smoking cessation|
12033133|NCT00340470|Behavioral|Driver Education|
12033134|NCT00340431|Drug|MSP1(42)-FVO & MSP1(42)-3D7|
12033135|NCT00340379|Drug|Ziprasidone|Target dosage 120-160mg/day based on tolerance
12033137|NCT00340379|Drug|Haloperidol|Target dosage 6-8mg/day based on tolerance.
12033138|NCT00340327|Drug|IMA-638|
12033139|NCT00340314|Procedure|Circumferential Pulmonary Vein Ablation|
12033140|NCT00340314|Drug|Antiarrhythmic Drug Therapy|
12033141|NCT00340184|Drug|paclitaxel, carboplatin|
12033142|NCT00340106|Behavioral|Counseling|
12033143|NCT00340093|Behavioral|Managing Diabetes|
12033144|NCT00340080|Drug|Abacavir|
12033145|NCT00340054|Other|questionnaire administration|
12033146|NCT00340054|Procedure|study of high risk factors|
12033147|NCT00339872|Drug|IMA-638|
12033148|NCT00339833|Drug|Salsalate|The intervention was salsalate (3g/day) for 7 days.
12033149|NCT00339833|Drug|Placebo|Identical placebo for 7 days.
12033150|NCT00339768|Drug|Amoxicillin/omeprazole|To treat Helicobacter pylori infections. 2 week course of amoxicillin 1gm bid, omeprazole 20mg bid. This factorial trial also investigated a supplement of vitamin C, vitamin E and selenium and a garlic supplement.
12033151|NCT00339690|Other|MITE-T-FASTtest kit|The primary objective of this randomized intervention trial is to determine if the use of an inhome test kit, as an adjunct to education, results in greater reductions in dust mite allergen levels than the use of educational materials alone.
12033152|NCT00339625|Other|low fat, high fiber, high fruit and vegetable eating plan|Participants were randomized to a low fat, high fiber, high fruit and vegetable (intervention arm) or their usual diet (control arm)
12033153|NCT00339586|Drug|Erlotinib|
12033154|NCT00339469|Dietary Supplement|LIFE|We are evaluating the effects of a legume enriched, low glycemic index, high fermentable fiber diet, on CRP, and C-peptide participants with four possible combinations of the risk factors insulin resistance and history of adenomatous polyps. In a randomized crossover design controlled feeding study each participant consumed the above experimental diet and a control diet for four weeks with a two week washout period between diets. 65 male participants were recruited and randomized into four groups. A secondary objective is to assess whether these endpoints change by IR status or a history of adenomas. In addition, potential fecal markers of CRC risk are being measured to assess changes in gastrointestinal inflammation, including mRNA from exfoliated fecal colonocytes. To our knowledge this is the first controlled feeding study: 1. to examine the effects of legumes or a low GI diet on markers of inflammation
12033155|NCT00339456|Drug|HAART|
12033156|NCT00339417|Drug|Albendazole|
12033157|NCT00339417|Drug|Ivermectin|
12033158|NCT00339365|Behavioral|Promoting First Relationships Program|Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants.
12033159|NCT00339365|Behavioral|Early Education Support Program|EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training.
12033160|NCT00339196|Drug|5 azacytidine - VALPROIC acid- Retinoic acid|5 azacytidine - VALPROIC acid- Retinoic acid
12033161|NCT00339183|Drug|Panitumumab|Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.
12033162|NCT00339183|Drug|FOLFIRI|FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m^2, leucovorin 400 mg/m^2 racemate (or 200 mg/m^2 I-leucovorin), 5-FU bolus 400 mg/m^2, 5-FU infusion 2400 mg/m^2.
12033163|NCT00339170|Behavioral|Computer-Based Cognitive Enhancement Training Program|Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing.
12033164|NCT00339170|Behavioral|Work Therapy Program|Participants in the work therapy program will attend two non-cognitive discussion groups per week.
12033165|NCT00339157|Drug|Anakinra|
12033166|NCT00339157|Biological|Pneumo23|
12033167|NCT00339144|Drug|Dasatinib|tablets, Oral, 100 mg, once daily for 4 weeks
12033168|NCT00339144|Drug|Dasatinib|tablets, Oral, 150 mg, once daily, 4 weeks
12033169|NCT00339144|Drug|Dasatinib|tablets, Oral, 200 mg, once daily for 4 weeks
12033170|NCT00339131|Drug|Ultratrace iobenguane I 131|
12033171|NCT00339118|Drug|doxorubicin, cytoxan|
12033172|NCT00339092|Behavioral|Modified Directly Observed Therapy|Treatment includes storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals. Participants in the MDOT program will report to the study site each morning for 3 months, Monday through Friday, to take their HIV medication and any other medications prescribed by their primary care doctors. At the end of 3 months, participants will no longer attend the study site for medication assistance. Participants will then attend Action Point, a county program that helps participants adhere to taking medication, for an additional 3 months.
12033173|NCT00339092|Behavioral|Standard Care|Participants assigned to standard care will report to the study site once a month for 9 months, but will not receive any assistance with taking HIV medications. Information about medication adherence, housing, income, use of health services, drug use, sexual practices, and mental health services will be collected at each visit.
12033174|NCT00339079|Drug|Fluoxetine|Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.
12033175|NCT00339079|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length.
12033253|NCT00338377|Biological|Dendritic Cell Immunization|1x10^7 to 2.5x10^8 MART-1 peptide-pulsed Dendritic Cells given by vein over 20-30 minutes approximately 4 hrs after receiving T cells.
12033176|NCT00339079|Other|Supportive Therapy|The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.
12033177|NCT00339079|Drug|Placebo|Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter.
12033178|NCT00339066|Drug|Sertraline|
12033179|NCT00339053|Drug|Immunonutrition ( Impact)|
12033180|NCT00339040|Biological|Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)|QHPV at week 0, 8, 24 and 96.
12033181|NCT00339040|Other|Placebo/QHPV|Placebo at week 0, 8, 24 and QHPV at week 96, 104, 120.
12033182|NCT00339014|Drug|Zonisamide CR and Bupropion SR|Zonisamide SR and Bupropion SR
12033183|NCT00339014|Other|Placebo|Identical placebo
12033184|NCT00339001|Drug|erythropoietin and early iron supplements|
12033185|NCT00338988|Drug|Capecitabine|1500 mg/m^2 PO twice daily x 14 days.
12033186|NCT00338988|Drug|Oxaliplatin|130 mg/m^2 IV over 2 hours on day 1 of cycle.
12033187|NCT00338975|Behavioral|Cognitive Behavioral Social Skills Training (CBSST)|There are 36 weekly group sessions, each session is 2 hours in length, with a half-hour break after the first hour. The intervention integrates CBT and SST techniques and neurocognitive compensatory aids. All participants are asked to identify a goal. The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. The CBT components are based on techniques developed for CBT in general and techniques developed specifically for patients with schizophrenia. Cognitive therapy is combined with role-play practice of communication skills and problem-solving training.
12033188|NCT00338975|Behavioral|Goal-focused supportive contact (GFSC)|"There are 36 weekly group sessions, each 2 hours in length, with a half-hour break after the first hour. GFSC has a number of specific goals and interventions, including providing a safe environment where the patient can discuss her/his feelings and concerns; to validate these feelings and concerns; and to provide support and guidance to the client so that she/he can make progress to solving problems or alleviating concerns and worries. Psychotic symptoms and cognition are not directly targeted. Therapists utilize non-specific therapeutic techniques, including providing unconditional positive regard, reflective listening, encouraging, paraphrasing, and summarizing. Therapists do not develop a formulation or teach skills."
12033189|NCT00338975|Behavioral|Social Skills Training|The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. Participants engage in role plays and problem solving.
12033190|NCT00338975|Behavioral|Goal Setting|All participants are asked to identify a personally meaningful goal as soon as possible in therapy. Over the 36 weeks, participants in CBSST learn skills related to goal attainment, while participants in GFSC do not receive skills aimed at goal attainment, but are encouraged to discuss their goals .
12033191|NCT00338962|Drug|paroxetine|paroxetine (40mg/day)
12033192|NCT00338962|Drug|desipramine|200 mg per day
12033193|NCT00338962|Drug|Naltrexone|50 mg per day
12033194|NCT00338962|Drug|Placebo|placebo
12033195|NCT00338949|Drug|Switch|Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.
12033196|NCT00338949|Drug|Control|Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
12033197|NCT00338936|Drug|Valsartan + Hydrochlorothiazide|
12033198|NCT00338923|Drug|HO/03/03|
12033199|NCT00338910|Drug|Budesonide 2 single doses, Metronidazole multiple-dose|Budesonide 3 mg single oral dose on Day 1 and Day 9. Metronidazole 750 mg b.i.d. from Day 2 until Day 8, Metronidazole 750 mg once daily (in the morning) on Day 9.
12033200|NCT00338897|Drug|SR123781A|
12033201|NCT00338884|Drug|Sunitinib malate|Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
12033202|NCT00338871|Procedure|home exercise|
12033203|NCT00338858|Other|walking and balance performance evaluation|
12033204|NCT00338858|Procedure|muscle strength, walking and balance performance|HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test
12033205|NCT00338845|Behavioral|Share Safer Sex program|The Share Safer Sex intervention will consist of a single, 30 to 40 minute, one-on-one counseling session designed to increase personal awareness of the participant's current unsafe behaviors and the associated risks, help her understand her motivation to change, and increase her knowledge about how to practice safe sex. Demonstrations and practice exercises will be used to improve participants' attitudes about, as well as intentions to practice, condom use. The counseling session will include the following activities: assessing readiness for change; building motivation for change; and performing exercises in decisional balance, identification of problem and problem-solving, and knowledge and skill-building.
12033206|NCT00338845|Behavioral|Standard didactic safer-sex counseling program|The standard counseling program will be based on a sexual risk reduction counseling program developed by the Centers for Disease Control and Prevention, and will focus on personal risk assessment and strategies for risk reduction. Additionally, it will incorporate risk reduction materials provided by CENSIDA, Mexico's National Center for AIDS Studies.
12033207|NCT00338832|Behavioral|Physically Ready for Invigorating Movement Every Day (PRIME)|The PRIME program is a lifestyle intervention focused on increasing physical activity. The intervention is cognitive/behaviorally based, 24-weeks in length, and a lifestyle PA intervention known to be effective in the general population of adults. The program has been modified based on theory and empirical findings about this special subgroup. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner.
12033254|NCT00338377|Drug|Cyclophosphamide|60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion
12033255|NCT00338377|Drug|Fludarabine|25 mg/m^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.
12033208|NCT00338832|Behavioral|Program for Activity, Leisure Skills, and Socialization (PALSS)|PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
12033209|NCT00338806|Behavioral|Interpersonal psychotherapy for prevention with adolescents|Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.
12033210|NCT00338806|Behavioral|Educational clinical monitoring|Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
12033211|NCT00338793|Drug|prednisolone|
12033212|NCT00338780|Drug|Lamivudine/ Placebo 100mg daily|
12033213|NCT00338767|Behavioral|Directly Observed Therapy (DOT)|DOT includes storefront directly observed therapy of prescribed anti-depressants. Participants will meet with a study psychiatrist, who will prescribe an appropriate antidepressant medication. Subsequent meetings with the psychiatrist will occur weekly for the first 3 weeks, and then monthly for the duration of the study. Additionally, participants will have DOT visits every weekday morning for 1 month to take their antidepressant medications. After the first month, DOT visits will occur weekly or biweekly, depending on the medication regimen.
12033214|NCT00338767|Drug|Fluoxetine|Medication treatment includes flouxetine for treatment of depression.
12033215|NCT00338754|Drug|Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks|
12033216|NCT00338728|Drug|Imatinib Mesylate|Given PO
12033217|NCT00338728|Drug|Letrozole|Given PO
12033218|NCT00338715|Device|PVI with Medtronic's Cardioblate BP2 radiofrequency catheter|Ablation of the right and left pulmonary veins
12033219|NCT00338702|Procedure|Autologous Platelet Gel|
12033220|NCT00338689|Dietary Supplement|Lower protein formula; Higher protein formula|During the intervention phase of the study, which is from inclusion in the study (latest age 2 weeks) until age 12 months, two experimental infant formulae with different protein content are fed to the enrolled infants; Lower protein formula and Higher protein formula. Additional a breastfed observational group without any intervention is included.
12033221|NCT00338663|Device|knee immobilization splint|
12033222|NCT00338650|Drug|adalimumab|
12033223|NCT00338637|Device|APOS shoe kit|
12033224|NCT00338624|Drug|oxybutynin chloride extended release|
12033225|NCT00338611|Behavioral|Home-based Pencil Push-Up Therapy|Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose
12033226|NCT00338611|Behavioral|Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics|Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose combined with additional computer vision therapy
12033227|NCT00338611|Behavioral|Office-based Vision Therapy/Orthoptics|Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises
12033228|NCT00338611|Behavioral|Placebo Office-based Vision Therapy/Orthoptics|Vision activities designed to simulate office-based therapy
12033229|NCT00338598|Drug|Glycine|Glycine, 0.8 gr per kg given in two daily doses
12033230|NCT00338598|Drug|placebo|
12033231|NCT00338585|Drug|alfimeprase|
12033232|NCT00338572|Behavioral|Exercise Program|Participants in the exercise group will receive a 12-week membership to the YMCA and will meet with a personal trainer twice a week. They will be encouraged to exercise on their own for an additional 3 to 4 days per week. Participants will also be provided with a pedometer, which will track the number of steps they take each day.
12033233|NCT00338572|Behavioral|Combined Exercise and Diet Program|Participants in this group will receive a 12-week membership to the YMCA and will meet with a personal trainer twice a week. They will be encouraged to exercise on their own for an additional 3 to 4 days per week. Participants will also be provided with a pedometer, which will track the number of steps they take each day. They will meet with a dietician and will be encouraged to reduce their caloric intake by incorporating low-fat, high-fiber foods into their diet.
12033234|NCT00338546|Drug|Cocaine hydrochloride|
12033235|NCT00338546|Drug|Dexmedetomidine|
12033236|NCT00338546|Procedure|Microneurography|
12033237|NCT00338546|Procedure|Laser doppler velocimetry|
12033238|NCT00338533|Device|endoscopic goniotomy|The goninotomy is performed through an endoscope; allowing the physician a better view of the structure within the eye
12033239|NCT00338507|Drug|Erdosteine|
12033240|NCT00338494|Drug|Clofarabine|The starting dose of clofarabine will be 10 mg/m2 once a week for 3 weeks repeated every 4 weeks with dose escalations to 15, 20 , 30 and 40 mg/m2/week.
12033241|NCT00338481|Drug|Morphine p.o.|"Morphine p.o. in red morphine drops calculated as 1/12 of the 24 hours opioid consumption converted to morphine p.o., max. 24 mg morphine p.o.and isotonic sodium chloride s.c."
12033242|NCT00338481|Drug|Morphine s.c.|"False red morphine drops without morphine p.o. and 60% of 1/12 of the 24 hours opioid consumption converted to morphine p.o. but given s.c., max. 14,4 mg"
12033243|NCT00338468|Drug|epoetin alfa|
12033244|NCT00338455|Drug|Natrecor (nesiritide)+Standard Care+dobutamine or milrinone|3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min
12033245|NCT00338455|Drug|Placebo+Standard Care+dobutamine or milrinone|28-day continuous infusion, no bolus
12033246|NCT00338442|Drug|VariZIG™|Biological / Vaccine
12033247|NCT00338429|Behavioral|FHP Sleep Program|Cognitive-Behavioral Intervention
12033248|NCT00338416|Drug|Epoetin alfa|
12033249|NCT00338403|Procedure|Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water|
12033250|NCT00338390|Drug|Abacavir|Change tenofovir to abacavir
12033251|NCT00338390|Drug|Didanosine|Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg.
12033252|NCT00338390|Drug|Abacavir+Lamivudine|Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
12033441|NCT00336908|Drug|a combination of MCT, LCT , and Fish Oil|
12033256|NCT00338377|Biological|T-Cells|On Days 0, up to 1.5 x 10^11 T-cells by vein infusion over 30-60 minutes.
12033257|NCT00338377|Biological|Interleukin-2|12-16 hours after completing the T cell infusion, all will receive high dose IL-2 on an inpatient basis at the standard dose of 720,000 IU/kg as an intravenous bolus over approximately a 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26 (+/- 7 days), as tolerated.
12033258|NCT00338377|Drug|Mesna|60 mg/kg with D5W or NS at 125 ml/hr infused intravenously over 24 hours on Day -7 and -6.
12033259|NCT00338377|Biological|Intrathecal T-Cells|5.0x10^9 T-cells administered on Day 1, and 10x10^9 T-cells on Day 15. 1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated.
12033260|NCT00338377|Biological|Intrathecal Interleukin-2|1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated. Then, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks patients switched to IL-2 maintenance.
12033261|NCT00338364|Behavioral|PAT|Coping and Distraction Intervention
12033262|NCT00338351|Biological|Pneumococcal (vaccine)|
12033263|NCT00338338|Drug|Lacidipine 4 or 6 mg (oral)|
12033264|NCT00338338|Drug|Amlodipine 5 or 10 mg(oral)|
12033265|NCT00338325|Behavioral|Reading program|Reading of children's story/picture books preoperatively
12033266|NCT00338312|Drug|Testosterone Transdermal System|testosterone patch (300 mcg/day) patch changed 2 times/week, for one year
12033267|NCT00338312|Drug|Placebo patch|placebo patch changed twice a week for one year
12033268|NCT00338299|Drug|Epoetin alfa|
12033269|NCT00338286|Other|Standard supportive care (packed RBC transfusion)|Per doctor prescription
12033270|NCT00338286|Drug|epoetin alfa + packed RBC transfusion|40,000 IU SC once a week.
12033271|NCT00338273|Drug|Aripiprazole|Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.
12033272|NCT00338273|Drug|Placebo|Tablets, Oral, 0 mg, Once daily, 8 weeks.
12033273|NCT00338260|Drug|MK0954, /Duration of Treatment : 5 Years|
12033274|NCT00338260|Drug|Comparator : atenolol /Duration of Treatment : 5 Years|
12033275|NCT00338247|Drug|lapatinib + capecitabine|Experimental
12033276|NCT00338221|Drug|alanyl-glutamine|
12033277|NCT00338221|Drug|glycine|
12033278|NCT00338208|Behavioral|Training in the Use of Low Vision Devices|
12033279|NCT00338195|Behavioral|Individualized caffeine cessation instructions|Intervention is described in the protocol
12033280|NCT00338182|Drug|AZD1152 part A|48-hour continuous intravenous infusion
12033281|NCT00338182|Drug|AZD1152 part B|2-hour intravenous infusion
12033282|NCT00338143|Drug|efalizumab|
12033283|NCT00338130|Drug|AZD6244|Oral liquid or Capsule
12033284|NCT00338130|Drug|Temozolomide|oral
12033285|NCT00338117|Drug|Galantamine hydrobromide|
12033286|NCT00338104|Drug|insulin glargine|Insulin glargine given at 40% of prior stable drip rate.
12033287|NCT00338104|Drug|insulin glargine|Insulin glargine given at 60% of prior stable drip rate.
12033288|NCT00338104|Drug|insulin glargine|Insulin glargine given at 80% of prior stable drip rate.
12033289|NCT00338091|Drug|Benazepril|
12033290|NCT00338091|Drug|Losartan|
12033291|NCT00338078|Device|nocturnal oxygen treatment from oxygen concentrators|
12033292|NCT00338065|Behavioral|Postural change|Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes
12033293|NCT00338065|Behavioral|Water drinking|Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.
12033294|NCT00338052|Drug|Norethindrone 1 mg / ethinyl estradiol 20 mcg|
12033295|NCT00338039|Drug|Cetuximab|500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy.
12033296|NCT00338039|Drug|Gemcitabine|"Induction Therapy: 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses.
~Chemotherapy Maintenance: 1 gm/m^2/week over 100 minutes weekly for 3 weeks then 1 week off."
12033297|NCT00338039|Drug|Oxaliplatin|Induction Chemotherapy: 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses.
12033298|NCT00338039|Drug|Capecitabine|Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation.
12033299|NCT00338039|Radiation|Radiotherapy|Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
12033300|NCT00338026|Drug|ECO-4601|Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)
12033301|NCT00338000|Drug|Epoetin alfa|
12033302|NCT00337987|Drug|Ontak|ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
12033303|NCT00337987|Drug|CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy|ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
12033304|NCT00337974|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
12033305|NCT00337974|Other|Educational DVDs|
12033306|NCT00337961|Procedure|Optic Nerve Sheath Fenestration|
12033307|NCT00337948|Drug|Epoetin alfa|
12033308|NCT00337935|Drug|Epoetin Alfa|Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
12033309|NCT00337935|Other|Standard of care|
12033310|NCT00337922|Drug|Lamivudine / Abacavir Sulfate|
12033311|NCT00337909|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
12033312|NCT00337909|Other|Educational DVDs|
12033313|NCT00337883|Drug|Erlotinib HCl (OSI-774)|
12033314|NCT00337870|Behavioral|PAT|Cognitive-Behavioral/Relaxation Intervention
12033315|NCT00337831|Procedure|Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration|Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
12033316|NCT00337818|Biological|Cervarix™|Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
12033548|NCT00336024|Drug|cisplatin|Given IV
12033317|NCT00337805|Other|Pentaspan|When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
12033318|NCT00337792|Drug|oxycodone + lorazepam versus fentanyl + midazolam|
12033319|NCT00337779|Drug|Glatiramer Acetate (GA) 40 mg|Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
12033320|NCT00337779|Drug|glatiramer acetate 20 mg|Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
12033321|NCT00337766|Drug|Desmopressin (DDAVP)|
12033322|NCT00337766|Drug|Placebo|
12033323|NCT00337753|Behavioral|Cognitive Behavioral Therapy|5-weeks of Cognitive Behavioral Therapy
12033324|NCT00337753|Behavioral|Wait-list|subjects assigned to wait-list condition for six-weeks
12033325|NCT00337740|Procedure|endoscopic variceal banding|
12033326|NCT00337740|Drug|propranolol|
12033327|NCT00337727|Drug|aprepitant|aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
12033328|NCT00337727|Drug|Comparator: ondansetron|Ondansetron 8 mg capsule Three day treatment period.
12033329|NCT00337727|Drug|Comparator: dexamethasone|dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
12033330|NCT00337727|Drug|Comparator: fosaprepitant dimeglumine|fosaprepitant dimeglumine 115 mg
12033331|NCT00337727|Drug|Comparator; Placebo (unspecified)|dexamethasone 12mg Pbo tablets.
12033332|NCT00337727|Drug|Comparator; Placebo (unspecified)|Aprepitant 80 mg & 125 mg Pbo capsules.
12033333|NCT00337714|Procedure|CVC impregnated with silver nanoparticles (AgTive®)|insertion of medicated silver nanoparticles CVC
12033334|NCT00337714|Procedure|CVC cannulation|placement of conventional trilumen CVCs
12033335|NCT00337701|Drug|enfuvirtide [Fuzeon]|90mg sc bid by Biojector 2000 NFID for 8 weeks
12033336|NCT00337701|Drug|enfuvirtide [Fuzeon]|90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.
12033337|NCT00337688|Device|isometric joystick|isometric joystick
12033338|NCT00337675|Drug|montelukast sodium|Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
12033339|NCT00337675|Drug|Comparator: Placebo (unspecified)|Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
12033340|NCT00337675|Drug|montelukast sodium|Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
12033341|NCT00337662|Drug|olanzapine|10-20 milligrams (mg), oral, daily, 10 weeks.
12033342|NCT00337662|Drug|risperidone|2-6 mg, oral, daily, for 10 weeks.
12033343|NCT00337662|Drug|risperidone|2-6 mg, oral, daily, 10 weeks
12033344|NCT00337649|Drug|Epothilone D|<100mg/m2 iv on days 1, 8 and 15 every 4 weeks
12033345|NCT00337649|Drug|Herceptin|4mg/kg iv loading dose followed by 2mg/kg iv weekly
12033346|NCT00337636|Procedure|Surgery to implant human CNS stem cells (HuCNS-SC)|single dose
12033347|NCT00337636|Drug|Medication to suppress the immune system|Immunosuppression for 12 months post transplant
12033348|NCT00337623|Drug|Prednisolone|
12033349|NCT00337610|Drug|sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day|Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
12033350|NCT00337610|Drug|comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day|Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
12033351|NCT00337597|Other|Glucose 5%|
12033352|NCT00337597|Other|NaCl 0.9%|
12033353|NCT00337584|Procedure|Pre-surgical screening|
12033354|NCT00337571|Drug|Aripiprazole|Tablets, Oral, once daily, 8 weeks
12033355|NCT00337571|Drug|Placebo|Tablets, Oral, once daily, 8 weeks
12033356|NCT00337558|Drug|Solifenacin succinate|tablet
12033357|NCT00337558|Behavioral|Simplified bladder training|Instructions
12033358|NCT00337545|Drug|RAD001|
12033359|NCT00337532|Drug|Paclitaxel|Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
12033360|NCT00337532|Drug|cisplatin|solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
12033361|NCT00337519|Procedure|allogeneic stem cell transplantation|see detailed description
12033362|NCT00337519|Drug|Alemtuzumab|alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14
12033363|NCT00337506|Drug|Dexamethasone|
12033364|NCT00337506|Drug|velcade|
12033365|NCT00337493|Drug|mycophenolate mofetil [CellCept]|Concentration-controlled
12033366|NCT00337493|Drug|mycophenolate mofetil [CellCept]|1g po bid
12033367|NCT00337493|Drug|Cyclosporine or tacrolimus|Reduced
12033368|NCT00337493|Drug|Cyclosporine or tacrolimus|Standard, as prescribed
12033369|NCT00337480|Behavioral|education|education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity
12033370|NCT00337467|Drug|Atazanavir + Ritonavir|Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks
12033371|NCT00337454|Drug|Dasatinib|Tablets, Oral, 50mg BID, once daily, 24 weeks.
12033372|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 24 weeks.
12033373|NCT00337454|Drug|Dasatinib|Tablets, Oral, 90mg BID, once daily, 24 weeks.
12033374|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 24 weeks.
12033375|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 12 weeks.
12033376|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 12 weeks.
12033377|NCT00337441|Drug|Epoetin Alfa (drug)|
12033437|NCT00336934|Dietary Supplement|pomegranate juice|Given orally daily.
12033438|NCT00336934|Other|placebo|Given orally daily.
12033439|NCT00336921|Drug|Alfuzosin|Once daily
12033378|NCT00337428|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)|GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
12033379|NCT00337428|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)|GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
12033380|NCT00337428|Biological|Comparator: REPEVAX™ (Concomitant)|REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
12033381|NCT00337428|Biological|Comparator: REPEVAX™ (Non-Concomitant)|REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
12033382|NCT00337415|Drug|MK0354|
12033383|NCT00337389|Drug|5- Fluorouracil (5-FU)|
12033384|NCT00337389|Drug|bevacizumab (Avastin)|
12033385|NCT00337389|Drug|Leucovorin|
12033386|NCT00337389|Drug|CoFactor (ANX-510)|
12033387|NCT00337376|Drug|Rapamune|Dose escalation as follows: 5mg PO, 10mg PO, 20mg PO, 40mg PO
12033388|NCT00337376|Drug|Abraxane|intravenous administration of 100mg/m2 Abraxane over 30 minutes, weekly for three out of four consecutive weeks.
12033389|NCT00337350|Drug|rosiglitazone|Rosiglitazone 4mg, one capsule per day for eight weeks
12033390|NCT00337350|Drug|placebo|matched placebo for rosiglitazone 4mg/day
12033391|NCT00337337|Behavioral|Multiple grain|
12033392|NCT00337337|Behavioral|Ordinary Asian- rice|
12033393|NCT00337324|Device|Frequency-modulated electromagnetic neural stimulation|
12033394|NCT00337298|Drug|Amlodipine|1 (5mg) tablet daily, given 14 days totally before measure of outcome.
12033395|NCT00337298|Drug|Lisinopril|Lisinopril 10 mg given daily for 14 days and then outcome was measured.
12033396|NCT00337285|Drug|Vyvanse (lisdexamfetamine dimesylate), NRP104|NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg
12033397|NCT00337272|Drug|Placebo|Placebo taken 30 minutes before bedtime days 1-28 of treatment period
12033398|NCT00337272|Drug|Ramelteon|8 mgs daily for days 1-28 of treatment period
12033399|NCT00337259|Drug|gemcitabine|D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks
12033400|NCT00337246|Biological|rituximab|
12033401|NCT00337246|Drug|cyclophosphamide|
12033402|NCT00337246|Drug|fludarabine phosphate|
12033403|NCT00337246|Drug|mitoxantrone hydrochloride|
12033404|NCT00337233|Procedure|yoga therapy|10 week yoga class
12033405|NCT00337207|Biological|bevacizumab|Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.
12033406|NCT00337194|Biological|monoclonal antibody SGN-30|Given IV
12033407|NCT00337194|Other|placebo|Given IV
12033408|NCT00337194|Drug|vinorelbine tartrate|Given IV
12033409|NCT00337194|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
12033410|NCT00337194|Drug|gemcitabine hydrochloride|Given IV
12033411|NCT00337194|Other|laboratory biomarker analysis|Correlative studies
12033412|NCT00337194|Other|pharmacological study|Correlative studies
12033413|NCT00337168|Drug|clofarabine|Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4
12033414|NCT00337168|Drug|cytarabine|Induction: 1g/m2/d; IV over 2 hrs; days 1-5 Re-induction (if necessary): 1g/m2/d; IV over 2 hrs; days 1-5 Consolidation: 1g/m2/d; IV over 2 hrs; days 1-4
12033415|NCT00337155|Drug|Radium-223 dichloride (BAY88-8223)|3 doses of radium-223 at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.
12033416|NCT00337129|Drug|eribulin mesylate|1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.
12033417|NCT00337116|Drug|iso sorbide dinitrate iv bolus or s/l|
12033418|NCT00337103|Drug|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
12033419|NCT00337103|Drug|Capecitabine|Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
12033420|NCT00337090|Drug|YM178|
12033421|NCT00337077|Drug|eribulin mesylate|Given IV
12033422|NCT00337064|Procedure|Radiation Therapy|
12033423|NCT00337051|Drug|Sevoflurane|General anesthesia using Sevoflurane (inhalation) as hypnotic
12033424|NCT00337051|Drug|Propofol|General anesthesia with propofol TCI
12033425|NCT00337038|Drug|N-acetylcystein(drug)|p.O t.Siran 200mg x1 during one weak
12033426|NCT00336986|Drug|recombinant interleukin-21|
12033427|NCT00336973|Drug|efalizumab|Subcutaneous repeating dose
12033428|NCT00336960|Drug|celecoxib|twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy
12033429|NCT00336960|Drug|fluorouracil|Patients receive concurrent fluorouracil IV continuously for 5 weeks.
12033430|NCT00336960|Procedure|conventional surgery|4-10 weeks after completion of chemoradiotherapy
12033431|NCT00336960|Radiation|radiation therapy|Patients undergo radiotherapy 5 days a week for 5 weeks
12033432|NCT00336960|Procedure|tumor biopsy|at baseline and then at the time of surgical resection
12033433|NCT00336960|Other|laboratory biomarker analysis|blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
12033434|NCT00336947|Drug|tegafur-gimeracil-oteracil potassium|
12033435|NCT00336947|Drug|tegafur-uracil|
12033436|NCT00336947|Procedure|adjuvant therapy|
12033442|NCT00336895|Drug|Myfortic|Myfortic 360mg or 720 mg BID for 90 days.
12033443|NCT00336882|Drug|Propofol|Propofol at a dose of 1 mg/kg/hour with a dose increase of 1 mg/kg until therapeutic effect (with a maximum dose of 5 mg/kg/hour)
12033444|NCT00336882|Drug|Midazolam|Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
12033445|NCT00336856|Drug|Cetuximab|The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
12033446|NCT00336856|Drug|Irinotecan|The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
12033447|NCT00336843|Drug|Zevalin-BuCyE|rituximab (IV, 250 mg/m2 on days -21 and -14) single dose of 90Y-ibritumomab (IV, 0.4 mCi/kg on day -14) Busulfan (IV, 0.8 mg/kg every 6 h from day -7 to day -5) Cyclophosphamide (IV, 50 mg/kg on days -3 and -2) Etoposide (IV, 200 mg/m2 every 12 h on days -5 and -4) Autologous stem cells infusion on day 0
12033448|NCT00336830|Behavioral|MD-endorsed Cardiac Rehabilitation referral|Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.
12033449|NCT00336830|Behavioral|Standard Cardiac Rehabilitation referral|Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.
12033450|NCT00336817|Drug|Myfortic|Myfortic 360mg or 720 mg BID for 90 days
12033451|NCT00336817|Drug|CellCept|CellCept 500mg or 1000mg BID for 90 days
12033452|NCT00336791|Drug|5-Fluorouracil|"FEC Chemotherapy: 500 mg/m^2 IV on day 1 of 21 day cycle.
~FAC Chemotherapy: 500 mg/m^2 IV on day 1 and day 4 of 21 day cycle."
12033453|NCT00336791|Drug|Cyclophosphamide|"FAC and FEC Chemotherapy:
~500 mg/m^2 IV on day 1 of 21 day cycle."
12033454|NCT00336791|Drug|Doxorubicin|FAC Chemotherapy: 50 mg/m^2 IV on day 1 over 72 hour continuous infusion or IV bolus.
12033455|NCT00336791|Drug|Paclitaxel|80 mg/m^2 by vein (IVPB) over 1 hour every week for 12 weeks
12033456|NCT00336791|Drug|Epirubicin|FEC: 100 mg/m^2 IV on day 1 of 21 day cycle.
12033457|NCT00336778|Drug|3TC, TDF, NLV|3TC 300 mg PO once daily+ TDF 300 mg PO once daily+ NLV 1250 mg PO twice daily (after 12 week lead-in period)
12033458|NCT00336765|Drug|XL647|Tablets supplied in 50-mg strength administered orally daily
12033459|NCT00336752|Procedure|non operative treatment|non operative treatment -casting for 6 weeks
12033460|NCT00336752|Procedure|operative treatment of ankle fractures|operative treatment of ankle fractures
12033461|NCT00336739|Drug|cinacalcet|
12033462|NCT00336713|Drug|Saredutant (SR48968C)|oral administration (capsules)
12033463|NCT00336713|Drug|Placebo|oral administration (capsules)
12033464|NCT00336700|Drug|Gemcitabine|1500mg/m2 IV over 150 min IV q 2 weeks 4 months
12033465|NCT00336700|Drug|Erlotinib|150 mg/d Daily, oral 12 months
12033466|NCT00336674|Biological|Intranasal insulin|440IU Insulin
12033467|NCT00336674|Other|Placebo|Placebo insulin carrier solution containing benzalkonium chloride and glycerol
12033468|NCT00336661|Device|PerioWave|
12033469|NCT00336648|Drug|Avastin (Bevacizumab)|10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months.
12033470|NCT00336648|Drug|Gemcitabine|400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
12033471|NCT00336648|Procedure|Radiation Therapy|Day 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions)
12033472|NCT00336635|Biological|cell-culture derived smallpox vaccine|
12033473|NCT00336622|Device|Splint fabricated by an OT versus an off-the-shelf splint|"Experimental:
~Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises
~Control:
~Control: Off-the-shelf splint and tendon-nerve gliding exercises Off-the-shelf splint and no tendon-nerve gliding exercises"
12033474|NCT00336596|Procedure|transcranial ultrasound in patients treated with iv t-PA|
12033475|NCT00336583|Drug|Oxaliplatin|Oxaliplatin, 130 mg per square meter, on day 1
12033476|NCT00336557|Procedure|NAbs testing|blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
12033477|NCT00336544|Drug|Cethromycin|Cethromycin 300 mg once per day (QD) for 7 days, administered orally
12033478|NCT00336544|Drug|Clarithromycin|Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
12033479|NCT00336531|Drug|itraconazole|2.5 mg/kg twice daily for the first two days --> once daily
12033480|NCT00336518|Drug|peginterferon alfa-2a|
12033481|NCT00336518|Drug|ribavirin|
12033482|NCT00336505|Drug|Cethromycin|Cethromycin 300 mg once per day (QD) for 7 days, administered orally
12033483|NCT00336505|Drug|Clarithromycin|Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
12033484|NCT00336492|Biological|infliximab|infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42
12033485|NCT00336492|Biological|infliximab|infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46
12033486|NCT00336492|Biological|infliximab|infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42
12033487|NCT00336492|Biological|infliximab|infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42
12033488|NCT00336479|Drug|Telaprevir|tablet
12033489|NCT00336479|Drug|Ribavirin|tablet
12033490|NCT00336479|Drug|Pegylated Interferon Alfa 2a|Solution for injection
12033491|NCT00336479|Other|Placebo|matching placebo tablet
12033492|NCT00336466|Drug|Human recombinant erythropoietin|
12033493|NCT00336453|Biological|Influenza Vaccination|0.5mL dose for intramuscular injection
12033494|NCT00336453|Biological|Influenza Vaccination|0.25mL dose for intramuscular injection
12033495|NCT00336414|Drug|cyclophosphamide-prednisone-azathioprine|
12033496|NCT00336401|Drug|Sevoflurane or Propofol|
12033497|NCT00336388|Device|Paracheck Device|
12033498|NCT00336375|Drug|artemether-lumefantrine|All treatment doses given either accompanied or not-accompanied with intake of fatty food.
12033499|NCT00336362|Drug|Hydroxyurea|"Hydroxyurea: Subjects will be treated for one month with hydroxyurea at a starting dose of 10 mg/kg orally (closest approximation to 500 mg capsule, alternate day dosing, e.g. 500 alternating with 1000 to achieve 750 mg average daily dose), once daily, with a gradual dose escalation up to 20 mg/kg (in non-splenectomized patients) and up to 25 mg/kg (in splenectomized patients).
~G-CSF: G-CSF will be administered subcutaneously. In general, G-CSF will be administered at 10μg/kg/day (5μg/kg on a twice a day schedule) for at least 4-5 days before leukapheresis and for 1-2 additional days during collections. For the splenectomized patients who are not receiving HU pretreatment, and for the splenectomized patients who receive HU pretreatment who have greater than or equal to 12,000 WBCs before G-CSF, G-CSF will start at a lower dose (for example, 1.5 or 2.5 µg/kg); the next doses will be adjusted by the Principal Investigator based on the observed degree of leukocytosis."
12033500|NCT00336349|Drug|Botulinum Toxin Type A|Botulinum Toxin Type A
12033501|NCT00336336|Drug|n-3 PUFA|1 g die per os
12033502|NCT00336336|Drug|Rosuvastatin|10 mg die per os
12033503|NCT00336336|Drug|Placebo|1 gram c. per os
12033504|NCT00336336|Drug|Placebo|10 mg c. per os
12033505|NCT00336323|Procedure|Laser Photocoagulation|Laser photocoagulation at baseline; If edema present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
12033506|NCT00336323|Drug|Bevacizumab|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
12033507|NCT00336323|Drug|Bevacizumab|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
12033508|NCT00336323|Drug|Bevacizumab|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
12033509|NCT00336323|Drug|Bevacizumab|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
12033510|NCT00336310|Drug|Repaglinide|
12033511|NCT00336297|Procedure|Woman Abuse Screening Tool|
12033512|NCT00336297|Procedure|Partner Violence Screen|
12033513|NCT00336297|Procedure|Computerized screening|
12033514|NCT00336297|Procedure|Face to face screening|
12033515|NCT00336297|Procedure|Written screening on forms|
12033516|NCT00336284|Other|Home Monitoring|Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant.
12033517|NCT00336284|Other|In-Office Conventional Follow-up|Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.
12033518|NCT00336245|Device|Copper T Intrauterine Contraceptive Device|
12033519|NCT00336245|Drug|Hormonal Contraception|
12033520|NCT00336232|Drug|Vitamin K|phylloquinone (vitamin K1) 500 mcg daily in third month
12033521|NCT00336219|Drug|Pantoprazole|Symptom Assessment after treatment with Pantoprozole 40 mg
12033522|NCT00336206|Drug|Alemtuzumab|
12033523|NCT00336193|Behavioral|Home visitation|Home visitation to improve maternal health and well-being and parenting practices
12033524|NCT00336180|Behavioral|HealthWise South Africa curriculum|18 classroom lessons
12033525|NCT00336167|Drug|bezafibrate (drug)|
12033526|NCT00336154|Drug|tetracyclin|
12033527|NCT00336141|Drug|Suberoylanilide hydroxamic acid|400 mg QD (every day) for five days, followed by 9 days of no vorinostat
12033528|NCT00336128|Behavioral|attitude change|TigerKids: setting based prevention program to reduce obesity risk factors in children
12033529|NCT00336128|Behavioral|adiposity prevention program|The behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting
12033530|NCT00336115|Biological|Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)|
12033531|NCT00336102|Other|physiologic testing|Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.
12033532|NCT00336102|Procedure|fatigue assessment and management|Fatigue Symptoms Inventory (FSI) survey
12033533|NCT00336102|Procedure|management of therapy complications|If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control
12033534|NCT00336089|Behavioral|exercise intervention|
12033535|NCT00336089|Other|educational intervention|
12033536|NCT00336089|Procedure|complementary or alternative medicine procedure|
12033537|NCT00336089|Procedure|fatigue assessment and management|
12033538|NCT00336089|Procedure|management of therapy complications|
12033539|NCT00336089|Procedure|pain therapy|
12033540|NCT00336089|Procedure|quality-of-life assessment|
12033541|NCT00336076|Other|Collection of blood and bone marrow|5-8 cc blood or bone marrow was additionally collected for analysis during diagnostic procedures. No assigned interventions.
12033542|NCT00336063|Drug|Azacitidine|Given SC
12033543|NCT00336063|Other|Laboratory Biomarker Analysis|Correlative studies
12033544|NCT00336063|Other|Pharmacological Study|Correlative studies
12033545|NCT00336063|Drug|Vorinostat|Given PO
12033546|NCT00336024|Drug|etoposide|Given IV
12033547|NCT00336024|Drug|cyclophosphamide|Given IV
12033549|NCT00336024|Biological|filgrastim|Given IV or SC
12033550|NCT00336024|Drug|carboplatin|Given IV
12033551|NCT00336024|Drug|thiotepa|Given IV
12033552|NCT00336024|Drug|methotrexate|Given IV
12033553|NCT00336024|Drug|leucovorin calcium|Given IV or orally
12033554|NCT00336024|Drug|vincristine sulfate|Given IV
12033555|NCT00336024|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous PBSC rescue
12033556|NCT00336024|Other|laboratory biomarker analysis|Correlative studies
12033557|NCT00336024|Procedure|quality-of-life assessment|Ancillary studies
12033558|NCT00336011|Device|Magnetic resonance imaging|
12033559|NCT00335998|Drug|triapine|Given IV
12033560|NCT00335998|Other|laboratory biomarker analysis|Correlative studies
12033561|NCT00335998|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
12033562|NCT00335998|Radiation|brachytherapy|Undergo intracavitary or interstitial brachytherapy
12033563|NCT00335998|Drug|cisplatin|Given IV
12033564|NCT00335998|Other|pharmacological study|Correlative studies
12033565|NCT00335985|Drug|GB-0998|8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days
12033566|NCT00335985|Drug|Placebo of GB-0998|8 mL/kg per day is intravenously administered for five successive days
12033567|NCT00335972|Drug|Remifentanil|Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
12033568|NCT00335972|Drug|Dexmedetomidine|Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
12033569|NCT00335959|Drug|capecitabine|850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.
12033570|NCT00335959|Drug|oxaliplatin|130 mg/m2 by 2-hour infusion Days 1 and 22
12033571|NCT00335959|Procedure|conventional surgery|Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy
12033572|NCT00335959|Radiation|radiation therapy|Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.
12033573|NCT00335946|Device|HANS non-needle acupuncture|
12033574|NCT00335946|Procedure|Stimulation of two acupuncture points bi-lateral|
12033575|NCT00335933|Drug|Gabapentin extended-release tablets|
12033576|NCT00335920|Drug|Dexamethasone-dihydrogenphosphate (4mg/ml)|
12033577|NCT00335907|Procedure|Fluid and Vasopressor Protocol|A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol
12033578|NCT00335894|Drug|hMG-IBSA|
12033579|NCT00335881|Biological|hepatitis B vaccine|
12033580|NCT00335868|Drug|danusertib|
12033581|NCT00335868|Other|laboratory biomarker analysis|
12033582|NCT00335868|Other|pharmacological study|
12033583|NCT00335855|Device|Auto-injector for IM/SC vaccine administration|
12033584|NCT00335829|Biological|bevacizumab|
12033585|NCT00335829|Drug|chemotherapy|
12033586|NCT00335829|Drug|embolization therapy|
12033587|NCT00335829|Procedure|hepatic artery infusion|
12033588|NCT00335816|Drug|fluorouracil|Given IV
12033589|NCT00335816|Drug|leucovorin calcium|Given IV
12033590|NCT00335816|Drug|oxaliplatin|Given IV
12033591|NCT00335816|Procedure|conventional surgery|Patients undergo surgery
12033592|NCT00335816|Radiation|radiation therapy|Patients undergo radiotherapy
12033593|NCT00335816|Other|laboratory biomarker analysis|Correlative studies
12033594|NCT00335816|Genetic|DNA analysis|Correlative studies
12033595|NCT00335816|Genetic|polymerase chain reaction|Correlative studies
12033596|NCT00335816|Other|immunohistochemistry staining method|Correlative studies
12033597|NCT00335790|Procedure|Hyperbaric Therapy|
12033598|NCT00335777|Drug|Migranal nasal spray|Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
12033599|NCT00335777|Drug|Migranal nasal spray|Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
12033600|NCT00335764|Drug|sorafenib tosylate|given orally
12033601|NCT00335764|Drug|erlotinib hydrochloride|given orally
12033602|NCT00335764|Drug|tipifarnib|given orally
12033603|NCT00335764|Drug|temsirolimus|IV administration
12033604|NCT00335751|Procedure|positron emission tomography computed tomography (PET/CT)|The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment.
12033605|NCT00335738|Drug|liposomal vincristine sulfate|Given IV
12033606|NCT00335738|Drug|carboplatin|Given IV
12033607|NCT00335738|Drug|etoposide|Given IV
12033608|NCT00335725|Drug|Follicle Stimulating Hormone|subcutaneous injection of FSH. Starting dose: 225 IU.
12033609|NCT00335725|Drug|Follicle Stimulating Hormone|subcutaneous injection of FSH. Starting dose: 225 IU.
12033610|NCT00335712|Drug|ONO-5129|
12033611|NCT00335699|Drug|Rosuvastatin|
12033612|NCT00335686|Drug|Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h|Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
12033613|NCT00335686|Drug|Nevirapine (Viramune): 1 comp (200mg)/12h|Nevirapine (Viramune): 1 comp (200mg)/12h
12033614|NCT00335673|Drug|Irbesartan (Aprovel)|Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.
12033615|NCT00335660|Drug|AV608|
12033616|NCT00335647|Drug|fluphenazine hydrochloride|
12033617|NCT00335621|Drug|Inhaled Tiotropium|
12033618|NCT00335595|Drug|XELOXA|XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 One cycle every 3 weeks
12033619|NCT00335595|Drug|XELOXA-A|"XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 during 6 cycles followed by Bevacizumab until disease progression or premature drop out of study.
~One cycle every 3 weeks"
12033620|NCT00335582|Drug|clonidine hydrochloride|One hour prior to surgery, patients randomized to the treatment arm will receive clonidine as both a 0.2 mg oral tablet and 0.2 mg/day transdermal patch patch will be removed on postoperative day 4 (or hospital discharge, whichever is earlier)
12033621|NCT00335569|Drug|hCG-IBSA|
12033622|NCT00335556|Drug|Doxorubicin Hydrochloride|Given IV
12033623|NCT00335556|Drug|Irinotecan Hydrochloride|Given IV
12033624|NCT00335556|Procedure|Conventional Surgery|Patients undergo resection
12033625|NCT00335556|Drug|Cyclophosphamide|Given IV
12033626|NCT00335556|Drug|Etoposide|Given IV
12033627|NCT00335556|Drug|Carboplatin|Given IV
12033628|NCT00335556|Biological|Dactinomycin|Given IV
12033629|NCT00335556|Drug|Vincristine Sulfate|Given IV
12033630|NCT00335556|Radiation|Radiation Therapy|Undergo radiotherapy
12033631|NCT00335556|Other|Laboratory Biomarker Analysis|Correlative studies
12033632|NCT00335543|Drug|cisplatin|
12033633|NCT00335543|Drug|gemcitabine hydrochloride|
12033634|NCT00335543|Procedure|adjuvant therapy|
12033635|NCT00335543|Procedure|conventional surgery|
12033636|NCT00335543|Procedure|neoadjuvant therapy|
12033637|NCT00335543|Radiation|radiation therapy|
12033638|NCT00335517|Drug|DepoDur|An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4cm to L1 level prior to injection. Two mililiters of air will be injected through the catheter to ensure patency. Aspiration will be done to ensure no intradural injections. Then the undiluted (1 or 1.5 cc) DepoDur will be injected.
12033639|NCT00335504|Drug|oligofructose-enriched inulin|Given orally
12033640|NCT00335504|Drug|sulindac|Given orally
12033641|NCT00335504|Drug|placebo|Given orally
12033642|NCT00335504|Drug|atorvastatin calcium|Given orally
12033643|NCT00335504|Other|laboratory biomarker analysis|Correlative studies
12033644|NCT00335491|Behavioral|exercise intervention|12 weeks of 3x/week training on a recumbent eccentric stepper
12033645|NCT00335491|Procedure|complementary or alternative medicine procedure|12 weeks of 3x/week training on the eccentron
12033646|NCT00335491|Procedure|fatigue assessment and management|The visual analog scale will be used to assess muscle soreness from the previous exercise session
12033647|NCT00335491|Procedure|physical therapy|12 weeks of 3x/week training on the eccentron
12033648|NCT00335478|Drug|Daptomycin|daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
12033649|NCT00335465|Drug|Insulin glargine|once a daily, sc injection, 100IU/ml
12033650|NCT00335452|Drug|Clopidogrel|oral administration
12033651|NCT00335452|Drug|acetylsalicyclic acid (ASA)|oral administration
12033652|NCT00335439|Drug|ketorolac tromethamine 0.5% (Acular®)|
12033653|NCT00335426|Procedure|Spinal manipulative therapy|
12033654|NCT00335413|Drug|Spironolactone|
12033655|NCT00335400|Drug|Anesthetic Dilating Gel|
12033656|NCT00335374|Drug|Pardoprunox|12 -42 mg
12033657|NCT00335361|Device|Intra Vas Device (IVD)|
12033658|NCT00335348|Drug|Bortezomib|Induction- 1.3mg/m2 IV days 1,4,8,11 every 3 weeks up to 8 cycles Consolidation- 1.3mg/m2 IV days 1,8,15,22 every 5 weeks up to 3 cycles Maintenance- 1.3mg/m2 IV days 1,15 every 4 weeks
12033659|NCT00335348|Drug|Dexamethasone|Induction- 20mg orally days 1,2,4,5,8,9,11,12 every 3 weeks up to 8 cycles Consolidation- 20mg orally days 1,2,8,9,15,16,22,23 every 5 weeks up to 3 cycles Maintenance- 20mg orally days 1,2,15,16 every 4 weeks
12033660|NCT00335335|Drug|iodixanol|
12033661|NCT00335322|Drug|Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)|Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
12033662|NCT00335322|Drug|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)|Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food)
12033663|NCT00335322|Drug|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)|Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd
12033664|NCT00335309|Procedure|Maxillary Sinus Irrigation|Twice a day irrigation with 100cc saline for 4 days
12033665|NCT00335309|Drug|IV Amoxicillin and Clavulanate acid|IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
12033666|NCT00335296|Device|PFx catheter|
12033667|NCT00335283|Drug|Lansoprazole Tablet|40 mg bid x 16 weeks
12033668|NCT00335283|Procedure|PH and impedence testing|24 hour ph monitoring
12033669|NCT00335283|Procedure|manometry|done prior to pH probe to measure length of esophagus
12033670|NCT00335283|Drug|lansoprazole|40mg bid
12033671|NCT00335283|Drug|placebo|one tablet bid
12033672|NCT00335270|Drug|fos-amprenavir calcium, ritonavir|
12033673|NCT00335270|Drug|abacavir/lamivudine as Epzicom|
12033674|NCT00335244|Drug|L-citrulline|150mg bolus X 1 after initiation of cardiopulmonary bypass followed by continuous infusion of 9mg/kg/hr IV, starting 4 hours post bolus administration and ending at 48 hours continuous infusion or discharge from the PCCU
12033675|NCT00335244|Drug|Placebo of intravenous L-citrulline|Placebo of intravenous L-citrulline
12033676|NCT00335231|Drug|gatifloxacin ophthalmic (ZYMAR)|
12033677|NCT00335218|Drug|Climodien / Lafamme (BAY86-5027)|1 tablet daily (2 mg EV + 2 mg DNG)
12033678|NCT00335218|Drug|Placebo|1 tablet daily
12033679|NCT00335205|Drug|ropinirole|
12033680|NCT00335192|Drug|Patients in treatment with 3TC + TDF + LPV/rtv, stop tenofovir during 4 weeks|3TC (300 mg/24 h, 1 tablet/24 h) + Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)
12033681|NCT00335192|Drug|Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeks|ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)
12033751|NCT00334802|Drug|gemcitabine|"Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)
~Phase 2: dose determined by phase 1"
12033682|NCT00335192|Drug|Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeks|3TC (300 mg/24 h, 1 tablet/24 h)+ ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h).
12033683|NCT00335179|Drug|Aldara (imiquimod 5% cream)|Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
12033684|NCT00335179|Drug|Vehicle cream|Vehicle cream in 250 mg
12033685|NCT00335166|Drug|Pardaprunox|12-42 mg
12033686|NCT00335166|Drug|pramipexole|1.5-4.5 mg
12033687|NCT00335166|Drug|Placebo Comparator|Placebo
12033688|NCT00335153|Drug|Levodopa-carbidopa intestinal gel|Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).
12033689|NCT00335153|Device|CADD-Legacy® 1400 ambulatory infusion pump|
12033690|NCT00335153|Device|PEG tube|percutaneous endoscopic gastrostomy tube
12033691|NCT00335153|Device|J-tube|jejunal tube
12033692|NCT00335140|Biological|Rituximab|Rituximab is administered intravenously. The initial rate is 50 mg/hr for the first hour. If no toxicity is seen, the rate may be escalated gradually in 50 mg/hour increments at 30-minute intervals to a maximum of 300 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased gradually in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr.
12033693|NCT00335140|Drug|Cytarabine|3 g/m2/day in 500 cc D5W IV over 2 hrs. x 2 doses 24hrs. apart, Weeks 11, 14
12033694|NCT00335140|Drug|Dexamethasone|16mg (week 1) PO daily Weeks 1, 2, 3, 4, 5, 6 Taper by 4 mg/wk, weeks 2, 3, by 2 mg/wk week 4, 5, 6
12033695|NCT00335140|Drug|Leucovorin|25 mg PO/IV every 6 hrs. x 12 doses, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally 10 mg PO every 12 hrs. x 8 doses, Weeks 2, 4, 6, 8, 10
12033696|NCT00335140|Drug|Methotrexate|"3.5 g/m2In 500 cc D5W + 25 mEq NaHCO3 IV over 2 hours, Weeks 1, 3, 5, 7, 9
~For patients with meningeal involvement additionally:
~12 mg Intrathecally, in preservative-free sterile .9NS Weeks 2, 4, 6, 8, 10 Via Ommaya or lumbar puncture"
12033697|NCT00335140|Drug|Procarbazine|100 mg/m2 PO daily x 7 days Weeks 1, 5, 9
12033698|NCT00335140|Drug|Vincristine|1.4 mg/m2 IV push, Weeks 1, 3, 5, 7, 9 2m2 (2.8 mg) dose cap
12033699|NCT00335114|Drug|cyclosporine ophthalmic emulsion|
12033700|NCT00335101|Drug|Iodixanol, Ioversol, Iopromide|
12033701|NCT00335088|Drug|Moxifloxacin and Povidone Iodine vs Povidone Iodine|
12033702|NCT00335075|Drug|Temozolomide|Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.
12033703|NCT00335075|Drug|Semustine|Semustine orally once every 28 days at a dose of 150 mg/m2/day.
12033704|NCT00335049|Device|progressive addition spectacle lens (bifocal)|Progressive addition lenses (PAL) with a +2.00 D add.
12033705|NCT00335049|Device|Single Vision Lenses (SVLs)|Single vision spectacle lenses.
12033706|NCT00335036|Device|ICD lead implant|Randomization of ICD lead type at implant
12033707|NCT00335036|Device|Thin leads|Thin (less than or equal to 7 French introducer) isodiametric ICD leads
12033708|NCT00335023|Other|Red blood cell transfusion|At least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL.
12033709|NCT00335010|Drug|Nitroglycerin|
12033710|NCT00334997|Procedure|endoscopic surgery|
12033711|NCT00334997|Procedure|laser surgery|
12033712|NCT00334997|Radiation|radiation therapy|
12033713|NCT00334984|Drug|glutamine|
12033714|NCT00334984|Procedure|chemoprotection|
12033715|NCT00334984|Procedure|management of therapy complications|
12033716|NCT00334984|Procedure|therapeutic nutritional supplementation|
12033717|NCT00334971|Procedure|Follicle Aspiration|Follicles will be aspirated using a transvaginal ultrasound guided needle.
12033718|NCT00334958|Drug|Placebo|BID for 12-day Titration Phase and 12-week Maintenance Phase.
12033719|NCT00334958|Drug|Rufinamide|400 mg twice daily (BID) orally uptitrated every 3 days in 400 mg BID increments up to 1600 mg BID (total daily dose of 3200 mg/day) over 12-day Titration Phase; followed by 1600 mg BID over 12-week Maintenance Phase.
12033720|NCT00334932|Drug|bortezomib|
12033721|NCT00334932|Drug|melphalan|
12033722|NCT00334932|Drug|pegylated liposomal doxorubicin hydrochloride|
12033723|NCT00334919|Behavioral|Diet (Anti-Inflammatory or standard diabetic diet)|6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks
12033724|NCT00334906|Drug|memantine HCl|
12033725|NCT00334893|Drug|eribulin mesylate|Given IV
12033726|NCT00334880|Drug|NRP104|
12033727|NCT00334867|Drug|cyclophosphamide|Given IV
12033728|NCT00334867|Drug|dexrazoxane hydrochloride|Given IV
12033729|NCT00334867|Drug|doxorubicin hydrochloride|Given IV
12033730|NCT00334867|Drug|etoposide|Given IV
12033731|NCT00334867|Drug|ifosfamide|Given IV
12033732|NCT00334867|Drug|topotecan hydrochloride|Given IV
12033733|NCT00334867|Drug|vincristine sulfate|Given IV
12033734|NCT00334867|Procedure|conventional surgery|Patients undergo surgery in week 18
12033735|NCT00334867|Procedure|radiation therapy|Patients undergo radiation therapy in week 19
12033736|NCT00334854|Drug|doxorubicin hydrochloride|
12033737|NCT00334854|Drug|ifosfamide|
12033738|NCT00334854|Procedure|adjuvant therapy|
12033739|NCT00334854|Procedure|conventional surgery|
12033740|NCT00334854|Procedure|neoadjuvant therapy|
12033741|NCT00334854|Radiation|radiation therapy|
12033742|NCT00334828|Drug|eritoran tetrasodium|Intravenous infusion at a total dose of 105 mg.
12033743|NCT00334828|Drug|Placebo|Matching placebo; intravenous infusion.
12033744|NCT00334815|Biological|Bevacizumab|Given IV
12033745|NCT00334815|Drug|Cisplatin|Given IV
12033746|NCT00334815|Drug|Docetaxel|Given IV
12033747|NCT00334815|Drug|Etoposide|Given IV
12033748|NCT00334815|Biological|Filgrastim|Given SC
12033749|NCT00334815|Biological|Pegfilgrastim|Given SC
12033750|NCT00334815|Radiation|Radiation Therapy|Undergo thoracic radiotherapy
12033828|NCT00334360|Drug|Control|No drugs given during controlled hypothermia
12033752|NCT00334802|Drug|paclitaxel|"Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
~Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles"
12033753|NCT00334789|Drug|Belinostat|Given IV
12033754|NCT00334789|Drug|Isotretinoin|Given orally
12033755|NCT00334789|Other|Pharmacological Study|Correlative studies
12033756|NCT00334776|Biological|MART-1 antigen|
12033757|NCT00334776|Biological|gp100:209-217(210M) peptide vaccine|
12033758|NCT00334776|Biological|therapeutic autologous dendritic cells|
12033759|NCT00334776|Biological|tyrosinase peptide|
12033760|NCT00334763|Biological|bevacizumab|
12033761|NCT00334763|Drug|carboplatin|
12033762|NCT00334763|Drug|chemoprotection|
12033763|NCT00334763|Drug|paclitaxel|
12033764|NCT00334763|Radiation|radiation therapy|
12033765|NCT00334750|Other|There is no intervention in this study.|This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada.
12033766|NCT00334737|Drug|Darbepoetin Alfa Injection|darbepoetin alfa injection 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks
12033767|NCT00334737|Drug|erythropoietin alfa injection|Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation
12033768|NCT00334737|Drug|sham injection|sham injection other names: not applicable
12033769|NCT00334724|Procedure|Home blood pressure measurement|Blood pressure controlled based on home blood pressure measurement
12033770|NCT00334724|Procedure|Office blood pressure measurement|Blood pressure controlled based on office blood pressure measurement
12033771|NCT00334711|Drug|Sulfonylurea|
12033772|NCT00334698|Drug|Cetirizine|
12033773|NCT00334698|Drug|Pseudoephedrine|
12033774|NCT00334698|Drug|Cetirizine with Pseudoephedrine|
12033775|NCT00334685|Drug|[S,S]-Reboxetine + Pregabalin|[S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
12033776|NCT00334685|Drug|Pregabalin|Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
12033777|NCT00334672|Biological|anti-thymocyte globulin|
12033778|NCT00334672|Drug|busulfan|
12033779|NCT00334672|Drug|cyclophosphamide|
12033780|NCT00334672|Drug|cyclosporine|
12033781|NCT00334672|Drug|dexamethasone|
12033782|NCT00334672|Drug|etoposide|
12033783|NCT00334672|Drug|methotrexate|
12033784|NCT00334672|Drug|mycophenolate mofetil|
12033785|NCT00334672|Drug|therapeutic hydrocortisone|
12033786|NCT00334672|Other|laboratory biomarker analysis|
12033787|NCT00334672|Procedure|allogeneic hematopoietic stem cell transplantation|
12033788|NCT00334672|Procedure|biopsy|
12033789|NCT00334659|Drug|apricitabine|
12033790|NCT00334646|Drug|Oral GW679769|150mg oral, once daily on days 1-3
12033791|NCT00334646|Drug|IV Cyclophosphamide 500-700mg/m2|IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
12033792|NCT00334633|Drug|tinidazole, metronidazole|Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
12033793|NCT00334620|Procedure|15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation|
12033794|NCT00334607|Biological|2-dose oral live attenuated G1P[8] human rotavirus vaccine|
12033795|NCT00334594|Drug|Cisplatin|Cisplatin 75 mg/m2 i.v. over approximately 2 hours on day 1 every 21 days
12033796|NCT00334594|Drug|Pemetrexed|Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 every 21 days
12033797|NCT00334594|Procedure|Therapeutic conventional surgery|Extrapleural pneumonectomy
12033798|NCT00334594|Radiation|Radiotherapy|CTV1 will receive 45 or 46 Gy. CTV2 will be treated up to a total dose of 55,9 to 56,2 Gy.
12033799|NCT00334581|Drug|Irbesartan|Administration throughout the study period
12033800|NCT00334581|Drug|Irbesartan|Administration throughout the study period
12033801|NCT00334568|Drug|Rosiglitazone XR (extended release) oral tablets|Rosi XR tablets
12033802|NCT00334568|Drug|Placebo|Placebo
12033803|NCT00334555|Other|different methods of partner notification|comparing patient referral, partner delivered medications and field intervention to treat sex partners
12033804|NCT00334555|Other|partner delivered meds|patient given meds to give to her partner
12033805|NCT00334555|Other|field intervention|health worker finds partners
12033806|NCT00334542|Drug|simvastatin|24-28 weeks of simvastatin
12033807|NCT00334529|Drug|Oseltamivir|
12033808|NCT00334503|Drug|Miglitol|
12033809|NCT00334490|Drug|Sildenafil|12.5 mg Sildenafil once with optional second dose
12033810|NCT00334490|Drug|Sildenafil|12.5 mg orally once with optional second dose
12033811|NCT00334490|Drug|Placebo|Oral Placebo in 5 mls distilled water
12033812|NCT00334477|Drug|tadalafil|
12033813|NCT00334464|Drug|Standard of care or genotyping dosing of warfarin dosing|
12033814|NCT00334438|Biological|rituximab|250mg/m2, IV, Days 1 and 8
12033815|NCT00334438|Drug|bortezomib|dose escalation 1.0, 1.3, or 1.5, IVP; Days 4, 8, 11, 15
12033816|NCT00334438|Radiation|yttrium Y 90 ibritumomab tiuxetan|Dose dependant upon platelet count (0.4mCi/kg) not to exceed 32mCi; Day 8
12033817|NCT00334438|Radiation|Indium 111 ibritumomab tiuxetan|5cmCi; IV day 1
12033818|NCT00334425|Drug|MENOPUR; GONAL-F|
12033819|NCT00334412|Drug|Ambisome|
12033820|NCT00334412|Drug|caspofungin|
12033821|NCT00334399|Drug|Miglitol|
12033822|NCT00334386|Drug|Torasemide Prolonged Release (loop diuretic)|
12033823|NCT00334386|Drug|Torasemide Immediate Release (loop diuretic)|
12033824|NCT00334373|Procedure|Post conditioning|4 cycles of balloon inflation /deflation (post-conditioning) within first minute of opening up artery in primary PCI for STEMI vs usual balloon inflation sequence
12033825|NCT00334360|Drug|dexmedetomidine|Dexmedetomidine (delivered by a computer-controlled IV infusion to target a plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia
12033826|NCT00334360|Drug|buspirone|Buspirone, 60 mg orally, will be given during controlled hypothermia.
12033827|NCT00334360|Drug|Bus and Dex|the combination of 60 mg buspirone and dexmedetomidine (target plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia
12033829|NCT00334347|Drug|Depakote ER|The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
12033830|NCT00334347|Drug|Depakote DR|The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
12033831|NCT00334334|Biological|Pneumococcal (vaccine)|
12033832|NCT00334321|Radiation|IMRT|
12033833|NCT00334321|Radiation|Intracavitary vaginal brachytherapy|
12033834|NCT00334321|Drug|Paclitaxel|
12033835|NCT00334321|Drug|Carboplatin|
12033836|NCT00334308|Procedure|Barley protein bread or control (casein) bread|
12033837|NCT00334295|Drug|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
12033838|NCT00334282|Drug|Pazopanib|Oral pazopanib tablet 800 mg once daily continuously
12033839|NCT00334282|Drug|placebo|matching placebo (800 mg tablet) once daily
12033840|NCT00334269|Behavioral|Health messaging at weekly home visits by health counsellor|
12033841|NCT00334269|Behavioral|Weekly home delivery of bottled spring water|
12033842|NCT00334269|Behavioral|Weekly afterschool physical activity program for 5-18y.o.|
12033843|NCT00334269|Behavioral|Cooking classes and grocery store tours with dietician|
12033844|NCT00334269|Behavioral|Pedometers to track/increase weekly physical activity|
12033845|NCT00334256|Drug|Tenofovir (TDF)|
12033846|NCT00334256|Drug|Emtricitabine (FTC)|
12033847|NCT00334243|Drug|Microflare protocol for IVF|
12033848|NCT00334243|Drug|Antagonist protocol for IVF|
12033849|NCT00334243|Drug|Demi-halt protocol for IVF|
12033850|NCT00334217|Behavioral|Cognitive Remediation|PSS Cogrehab
12033851|NCT00334204|Device|measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy|measuring Platelet Function Analyser (PFA) -100 platelet function before kidney biopsy
12033852|NCT00334191|Drug|Sodium Bicarbonate|
12033853|NCT00334191|Drug|Placebo|
12033854|NCT00334178|Drug|Laxymig ER (drug)|
12033855|NCT00334165|Procedure|Auricular acupuncture (procedure)|
12033856|NCT00334152|Drug|casopitant|
12033857|NCT00334139|Drug|Zoledronic Acid|every 4 weeks for 4 months
12033858|NCT00334126|Drug|paliperidone ER tablets, quetiapine tablets, placebo - all over encapsulated|
12033859|NCT00334113|Behavioral|TLC-PED|Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
12033860|NCT00334100|Behavioral|Exercise|Treadmill exercise
12033861|NCT00334087|Behavioral|feeding habits|
12033862|NCT00334074|Drug|Clofarabine and Cytarabine|Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in selected Elderly Patients at high risk of anthracycline toxicity
12033863|NCT00334061|Device|Penumbra System|
12033864|NCT00334048|Drug|Ropinirole (Requip)|1 mg extended release formulation given once per day to a maximum of 4 per day
12033865|NCT00334035|Drug|Quetiapine|
12033866|NCT00334022|Drug|enfuvirtide|1ml BID
12033867|NCT00333996|Drug|Dexamethasone|
12033868|NCT00333983|Device|Robotic Upper Extremity Neurorehabilitation|Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
12033869|NCT00333983|Other|Traditional Upper Extremity Exercise Group|Upper extremity stretching, skateboard reaching activities, and arm ergometer
12033870|NCT00333970|Behavioral|cognitive remediation|individual cognitive training
12033871|NCT00333944|Drug|Pralidoxime(drug)|
12033872|NCT00333931|Drug|Phenytoin|
12033873|NCT00333931|Behavioral|Cognitive Behavioral Therapy|
12033874|NCT00333918|Drug|bromfenac ophthalmic solution|
12033875|NCT00333918|Drug|placebo comparator|
12033876|NCT00333905|Procedure|Ischemic exercise training|
12033877|NCT00333892|Procedure|leukapheresis|pack of cells as per protocol
12033878|NCT00333879|Device|Virtual Sound System|Virtual Sound System is tested for efficacy in its ability to realistically simulate Street Crossings sounds in a safe indoor environment. If efficacious, Blind students will be able to practice crossing streets in safety indoors.
12033879|NCT00333866|Drug|pregabalin|600mg/day
12033880|NCT00333866|Drug|pregabalin|450mg/day
12033881|NCT00333866|Drug|pregabalin|300mg/day
12033882|NCT00333866|Drug|placebo|placebo
12033883|NCT00333853|Device|OneTouch(r) UltraSmart(r)|
12033884|NCT00333840|Drug|imatinib mesilate|imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
12033885|NCT00333840|Drug|interferon-alpha (INF-a)|interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day.
12033886|NCT00333840|Drug|cytarabine (ARA-C)|cytarabine 20 mg/m^2/day (max 40 mg) SC for 10 days every month.
12033887|NCT00333827|Drug|optimal therapy for cardiaca failure|optimal therapy for cardiaca failure
12033888|NCT00333827|Procedure|cell|stem cell
12033889|NCT00333814|Drug|Dexamethasone|Dexamethasone 350 µg; injection drug delivery system at Day 0
12033890|NCT00333814|Drug|dexamethasone|Dexamethasone 700 µg injection drug delivery system at Day 0
12033891|NCT00333814|Drug|Sham injection|Sham injection at Day 0
12033892|NCT00333801|Behavioral|Vocational Rehabilitation Program (VRP)|Vocational Rehabilitation Program (VRP) is a treatment-as-usual method using traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
12033893|NCT00333801|Behavioral|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) is an evidence--based model of supported employment that emphasizes rapid job search within client preferences, community job development, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of the IPS specialist within the treatment team.
12033948|NCT00333307|Drug|recombinant human relaxin|
12033949|NCT00333294|Drug|Gefitinib|
12033894|NCT00333788|Biological|Certolizumab pegol (CDP870)|400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
12033895|NCT00333775|Drug|Docetaxel|Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
12033896|NCT00333775|Drug|Placebo to bevacizumab|Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
12033897|NCT00333775|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
12033898|NCT00333762|Device|Smart Power Assistance Module (SPAM)|Experimental Power wheelchair utilized to traverse prescribed course
12033899|NCT00333762|Device|Smart Wheelchair Component System (SWCS)|Experimental power wheelchair utilized to traverse prescribed course
12033900|NCT00333749|Biological|Drinking or rinsing the mouth 2-3 times for 1 day|
12033901|NCT00333749|Biological|Pasturlized cow milk|Drinking or rinsing the mouth 2-3 times for one day.
12033902|NCT00333736|Device|Biojector|All patients received biojector to use with BID enfuvirtide doses
12033903|NCT00333723|Drug|Rosiglitazone|
12033904|NCT00333710|Behavioral|Individual psychotherapy|Individual face-to-face contact with educational and goal setting components
12033905|NCT00333710|Behavioral|Telehealth Intervention|Individual telephone contact with educational and goal setting components
12033906|NCT00333697|Other|Comprehensive Duplex Ultrasound (diagnostic study)|A sigle duplex ultrasound examination of the deep venous system of the leg(s) suspected of deep vein thrombosis. Deep veins of the leg are examined for evidence of thrombosis from the inguinal ligament to the level of the malleolus.
12033907|NCT00333684|Device|BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS|prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs
12033908|NCT00333671|Drug|Glycerol|
12033909|NCT00333658|Behavioral|Goal setting and work feedback group|Goal setting and feedback using WBI
12033910|NCT00333645|Drug|Caspofungin|
12033911|NCT00333632|Drug|Dexmedetomidine|
12033912|NCT00333632|Drug|Propofol|
12033913|NCT00333632|Drug|Midazolam|
12033914|NCT00333632|Drug|Fentanyl|
12033915|NCT00333632|Drug|Isoflurane|
12033916|NCT00333619|Behavioral|Nonpharmacological sleep intervention|The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies
12033917|NCT00333619|Behavioral|Active control|Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
12033918|NCT00333606|Behavioral|Acupuncture|Body acupuncture of 1 specific point per trial session
12033919|NCT00333593|Device|Large pore dialyser|
12033920|NCT00333593|Device|Standard dialyser|
12033921|NCT00333567|Drug|Lumiracoxib|
12033922|NCT00333554|Dietary Supplement|DHA Treatment|DHA study treatment given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food) depending on age of child.
12033923|NCT00333554|Dietary Supplement|Placebo for DHA|Study placebo given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food)depending on age of child.
12033924|NCT00333541|Behavioral|Using internet/E-mail for follow-up|follow-up via email link to survey
12033925|NCT00333528|Drug|Human butyrylcholinesterase (HuBChE) derived from human plasma|Intramuscular administration
12033926|NCT00333528|Drug|Placebo: Normal saline|Intramuscular administration
12033927|NCT00333515|Drug|Human Butyrylcholinesterase (HuBChE) derived from human plasma|Administration via IV infusion at a rate of 50 mg/min (2 mL/min)
12033928|NCT00333515|Drug|Placebo: Normal saline|Administration via IV infusion at a rate of 50 mg/min (2 mL/min)
12033929|NCT00333502|Drug|Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer|Subjects who meet inclusion/exclusion criteria will receive CRLX101 every other week.
12033930|NCT00333489|Drug|valsartan|
12033931|NCT00333476|Drug|MSI-1256F (Squalamine Lactate)|
12033932|NCT00333463|Behavioral|Intervention|The intervention group watched an educational video, reviewed current barriers to drop-taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices.
12033933|NCT00333450|Biological|Pneumococcal vaccine|
12033934|NCT00333437|Drug|Mycophenolate mofetil|
12033935|NCT00333424|Biological|pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine|6mg pHIS-HIV-AE at weeks 0, 4 and 8; 3 x 10e8 pfu/mL rFPV-HIV-AE at week 12
12033936|NCT00333411|Drug|BIRT 2584 XX|
12033937|NCT00333411|Drug|Placebo|
12033938|NCT00333398|Biological|CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free|CSL influenza vaccine-prefilled syringe presentation (thimerosal-free) 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.
12033939|NCT00333398|Biological|CSL Trivalent Inactivated Influenza Vaccine with Thimerosal|CSL influenza vaccine-multiple dose vial presentation (thimerosal-containing) containing 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.
12033940|NCT00333398|Biological|Placebo with Thimerosal|Phosphate buffered isotonic saline solution containing thimerosal. Single dose of 0.5 mL administered on study day 0.
12033941|NCT00333385|Drug|ceftazidime|
12033942|NCT00333372|Drug|Z-338|
12033943|NCT00333359|Drug|XP13512 (GEn)|1200 mg XP13512, orally, once daily for 52 weeks
12033944|NCT00333346|Drug|Administration of tramadol intravenously|
12033945|NCT00333333|Procedure|Cord blood|Cord blood will be obtained at the time of delivery.
12033946|NCT00333320|Procedure|postconditioning|patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion
12033947|NCT00333320|Procedure|Control group|Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.
12033950|NCT00333294|Procedure|Radiation therapy|
12033951|NCT00333294|Drug|Cisplatin|
12033952|NCT00333294|Drug|Vinorelbine|
12033953|NCT00333281|Drug|tadalafil|
12033954|NCT00333268|Drug|Next Generation Ophthalmic Irrigating Solution (NGOIS)|Volume sufficient to irrigate adequately during cataract surgery
12033955|NCT00333268|Drug|BSS Plus|Volume sufficient to irrigate adequately during cataract surgery
12033956|NCT00333255|Drug|Nepafenac Ophthalmic Suspension, 0.1%|
12033957|NCT00333242|Drug|dextromethorphan|dextromethorphan PO titrated to 480 mg/day x 5 weeks
12033958|NCT00333229|Drug|Zoledronic Acid|4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.
12033959|NCT00333229|Drug|Placebo|Matching Placebo
12033960|NCT00333216|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|Posterior juxtascleral administration of suspension
12033961|NCT00333216|Drug|Anecortave Acetate Sterile Suspension, 60 mg/ML|Posterior juxtascleral administration of suspension
12033962|NCT00333216|Other|Anecortave Acetate Vehicle|Sham posterior juxtascleral administration of suspension
12033963|NCT00333203|Drug|Next Generation Ophthalmic Irrigating Solution (NGOIS)|Volume sufficient to irrigate adequately during cataract surgery
12033964|NCT00333203|Other|BSS Plus|Volume sufficient to irrigate adequately during cataract surgery
12033965|NCT00333190|Device|CD+8 T cell depletion|CD8 depleted product Given through central line after treatment with fludarabine and busulfex intravenously for 4 days
12033966|NCT00333177|Behavioral|Cognitive remediation training (CT)|Cognitive remediation training includes computerized cognitive training plus learning skills group.
12033967|NCT00333177|Behavioral|Healthy behavior training (HBT)|Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.
12033968|NCT00333177|Drug|Risperidone, administered orally (Oral Ris)|Oral risperidone at dosage judged optimal by treating psychiatrist
12033969|NCT00333177|Drug|Risperidone, administered via injection (RLAI)|Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
12033970|NCT00333164|Drug|Asprin, Cilostazol|
12033971|NCT00333151|Drug|liraglutide|
12033972|NCT00333151|Drug|rosiglitazone|
12033973|NCT00333151|Drug|metformin|
12033974|NCT00333138|Drug|FTY720|FTY720 capsule was taken orally once a day
12033975|NCT00333138|Drug|Placebo|Placebo 1.25 mg capsule was given once daily
12033976|NCT00333125|Drug|Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)|One drop in the study eye(s) once daily, 9 PM, for 6 weeks
12033977|NCT00333125|Drug|Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)|One drop in the study eye(s) twice daily for 6 weeks
12033978|NCT00333125|Other|Timolol Vehicle|One drop in the study eye(s) once daily for 6 weeks
12033979|NCT00333112|Drug|solifenacin succinate|Oral
12033980|NCT00333112|Drug|tamsulosin|oral
12033981|NCT00333112|Drug|placebo|oral
12033982|NCT00333099|Dietary Supplement|Impact (R) Enteral Nutrition|mucositis frequency, treatment tolerance
12033983|NCT00333099|Other|impact|"1500 calories every day :
~-5 days before the begining of the chemoradiotherapy and until the last day of the treatment"
12033984|NCT00333086|Drug|Letrozole|
12033985|NCT00333073|Device|Bulkamid|initial injection with option for second (if required)
12033986|NCT00333060|Drug|OT-551 ophthalmic solution|
12033987|NCT00333047|Drug|Letrozole|
12033988|NCT00333034|Drug|Etanercept|
12033989|NCT00333021|Drug|Fondaparinux sodium|
12033990|NCT00333021|Drug|GSK576428|
12033991|NCT00333008|Drug|Doxil|
12033992|NCT00333008|Drug|Cyclophosphamide|
12033993|NCT00333008|Drug|Vincristine|
12033994|NCT00333008|Drug|Prednisone|
12033995|NCT00333008|Drug|Rituximab|
12033996|NCT00333008|Drug|Pegfilgrastim|
12033997|NCT00332995|Drug|dapivirine (TMC120) vaginal ring|
12033998|NCT00332982|Behavioral|Focused knowledge translation strategies|
12033999|NCT00332969|Drug|Octreotide|
12034000|NCT00332956|Biological|rFIV vaccine|rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
12034001|NCT00332956|Biological|rF1V vaccine|rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
12034002|NCT00332956|Biological|rF1V vaccine|rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
12034003|NCT00332956|Biological|rF1V vaccine 160 mcg given on Study Days 0, 56, 182|rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182
12034004|NCT00332943|Procedure|MR colonography with fecal tagging|
12034005|NCT00332930|Biological|recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens|
12034006|NCT00332930|Biological|HIV gag-pol antigens and interferon-gamma (IFN-y)|
12034007|NCT00332917|Drug|Pardoprunox|12-42 mg
12034008|NCT00332904|Drug|propranolol|tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
12034009|NCT00332904|Drug|spironolactone|tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
12034010|NCT00332891|Drug|SR58611A|
12034011|NCT00332878|Behavioral|Stepping Stones|a comprehensive sexual and reproductive health promotion programme lasting about 50 hours comprising 13 content sessions of about 3 hours duration and 4 meetings of peer groups
12034012|NCT00332878|Behavioral|stepping Stones short|3 hour intervention on HIV and safer sex
12034013|NCT00332865|Behavioral|Swallowing Exercises|Daily exercises
12034014|NCT00332852|Drug|Letrozole|2.5 mg/day - oraly
12034015|NCT00332839|Drug|Everolimus|Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).
12034016|NCT00332839|Drug|Cyclosporin A (CsA)|The dose was based on the participants' blood level of C0h (80-150 ng/ml).
12034017|NCT00332839|Drug|Tacrolimus|The dose was based on the participants' blood level of C0h (5-10 ng/ml).
12034018|NCT00332839|Drug|Enteric Coated - Mycophenolate Sodium (EC-MPS)|The dose was ≥ 720 mg/day.
12034019|NCT00332839|Drug|Corticosteroids|Corticosteroids were given according to local standard and/or the Investigators' discretion.
12034020|NCT00332826|Drug|Technosphere Insulin|
12034021|NCT00332813|Behavioral|HIV Risk Behavior Intervention|
12034022|NCT00332800|Drug|Nutritional Supplementation|
12034023|NCT00332787|Drug|Fluoxetine|
12034024|NCT00332774|Drug|Nepafenac ophthalmic solution 0.1%|1 drop 4 times daily for 90 days
12034025|NCT00332774|Drug|Ketorolac Tromethamine ophthalmic solution 0.4%|1 drop 4 times daily for 90 days
12034026|NCT00332774|Other|Nepafenac ophthalmic suspension vehicle|
12034027|NCT00332761|Drug|Caduet|
12034028|NCT00332748|Drug|Oral Taxane|
12034029|NCT00332735|Drug|spinal administration of articaine|
12034030|NCT00332735|Drug|spinal administration of bupivacaine|
12034031|NCT00332722|Procedure|Cervical facet joint nerve blocks|
12034032|NCT00332709|Drug|Letrozole|2.5 mg/day for 3 years
12034033|NCT00332709|Drug|Zoledronic acid|4 mg every 6 months
12034034|NCT00332696|Drug|Octreotide LAR|Octreotide long-acting release (LAR) 30 mg intramuscular injection.
12034035|NCT00332696|Drug|Octreotide (Immediate release)|Immediate-release Octreotide supplied in 100 µg/mL ampules.
12034036|NCT00332696|Drug|methylprednisolone|methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).
12034037|NCT00332696|Drug|Placebo|Physiologic saline solution
12034038|NCT00332683|Procedure|Maintaining low (15mmHg) ETT cuff pressure|Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg
12034039|NCT00332683|Procedure|Maintaining a normal pressure in the ETT cuff|No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff
12034040|NCT00332670|Procedure|10.000lux blue 1 hour every day during three weeks|10.000lux during 60 minutes, starting 1 hour after wake-up, during 3 weeks
12034041|NCT00332670|Procedure|50lux dim red 1 hour every day during three weeks|50 lux red light, 60 minutes every morning, starting 1 hour after wake-up, during three weeks
12034042|NCT00332657|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|One 0.5 mL injection into the PJD at 6-month intervals for 42 months
12034043|NCT00332657|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|One 0.5 mL injection into the PJD at 6-month intervals for 42 months
12034044|NCT00332657|Other|Anecortave Acetate Vehicle|One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.
12034045|NCT00332644|Drug|nicotine patch|used according to FDA package label
12034046|NCT00332644|Drug|nicotine lozenge|used according to FDA-approved package directions
12034047|NCT00332644|Drug|nicotine patch + nicotine lozenge|dosage of both according to FDA-approved dosing schedule
12034048|NCT00332644|Drug|bupropion|dosage according to FDA-approved instructions
12034049|NCT00332644|Drug|bupropion + lozenge|dosage according to FDA approved standard instructions
12034050|NCT00332644|Drug|placebo|dosage same as active drug conditions
12034051|NCT00332631|Drug|N-acetylcysteine|
12034052|NCT00332631|Drug|Placebo|
12034053|NCT00332618|Device|OXYGENATED GLYCEROL TRIESTERS|
12034054|NCT00332605|Drug|Naltrexone plus N-Acetyl Cysteine|daily
12034055|NCT00332605|Drug|Placebo|daily
12034056|NCT00332579|Drug|Naltrexone|daily
12034057|NCT00332579|Drug|Placebo|daily
12034058|NCT00332566|Biological|DTPw-HBV/Hib Kft vaccine GSK323527A|Intramuscular injection, 1 dose
12034059|NCT00332566|Biological|Tritanrix™-HepB/Hiberix™|Intramuscular injection, 1 dose
12034060|NCT00332553|Drug|Raloxifene|
12034061|NCT00332553|Drug|medroxyprogesterone acetate|
12034062|NCT00332553|Drug|estrogen|
12034063|NCT00332553|Drug|17 beta estradiol|
12034064|NCT00332540|Drug|bimatoprost/timolol fixed combination|
12034065|NCT00332514|Behavioral|telephone call by a pharmacist|
12034066|NCT00332488|Drug|Technosphere Insulin|Inhalation, 15U/30U, prandial
12034067|NCT00332488|Drug|Metformin & Secretagogues|Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
12034068|NCT00332488|Drug|Technosphere Insulin & Metformin|Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
12034069|NCT00332462|Drug|Cyclosporine (Sandimmun® i.v.)|Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
12034070|NCT00332462|Drug|Cyclosporine (Sandimmun® Optoral)|Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
12034071|NCT00332436|Drug|brimonidine/timolol fixed combination|
12034072|NCT00332397|Device|Rapamycin-eluting Stent|due to randomization, Cypher stent will be implanted
12034073|NCT00332397|Device|Zotarolimus-eluting Stent|due to randomization, Endeavor stent will be implanted
12034074|NCT00332397|Device|Rapamycin-eluting Stent|due to randomization, rapamycin-eluting stent will be implanted
12034075|NCT00332384|Drug|brimonidine/timolol fixed combination|
12034076|NCT00332371|Device|CPFA (Coupled Plasma Filtration Adsorption)|"CPFA is a specific method for the treatment of sepsis.
~It consists of:
~a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa)
~a hemofilter (polyethersulfone 1,4 m2)
~a cartridge (contains approximately 140 ml of hydrophobic styrenic resin)
~The kit is lodged in the Bellco Lynda machine (Bellco Mirandola, Italy). The treatment consists of the separation of plasma from the whole blood with adsorption of the inflammatory mediators and cytokines from the plasma, and a subsequent purification step by way of a hemofilter."
12034077|NCT00332345|Drug|brimonidine/timolol fixed combination|
12034078|NCT00332332|Biological|etanercept|etanercept subcutaneous injection
12034079|NCT00332319|Drug|GW679769|
12034080|NCT00332306|Drug|Didanosine, Lamivudine, Efavirenz|Didanosine 250mg patients <60kg, 400mg patients > 60kg once daily Lamivudine 300 mg once daily Efavirenz 600 mg once daily All drugs will be given for 24 months
12034081|NCT00332306|Drug|Didanosine, Lamivudine, Nevirapine|Didanosine 250 mg once daily for patients < 60kg, 400 mg OD patients > 60kg Lamivudine 300 mg once daily Nevirapine 400 mg once daily All drugs will be given for 24 months
12034082|NCT00332293|Drug|Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%|1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
12034083|NCT00332293|Drug|Moxifloxacin hydrochloride ophthalmic solution 0.5% as base|1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
12034084|NCT00332280|Drug|AMT2003|
12034085|NCT00332267|Procedure|Endotoxin infusion, Normobaric hypoxia|
12034086|NCT00332254|Drug|Anakinra|150 mg IL1Ra ia x1 vs saline ia x1
12034087|NCT00332241|Drug|Aripiprazole|Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
12034088|NCT00332241|Drug|Placebo|Tablets, Oral, once daily, 8 weeks
12034089|NCT00332228|Drug|depot naltrexone|long-acting depot parenteral formulation of naltrexone
12034090|NCT00332228|Behavioral|Compliance enhancement (CE)|Compliance enhancement (CE), simulating standard treatment with oral naltrexone
12034091|NCT00332228|Drug|BNT|behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
12034092|NCT00332215|Drug|Inhaled Sodium Pyruvate|
12034093|NCT00332202|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
12034094|NCT00332202|Drug|placebo|oral, daily
12034095|NCT00332189|Drug|sapropterin dihydrochloride|5-20mg/kg/day orally, dose may be adjusted up or down as needed at the discretion of the investigator in increments of 5mg/kg/day.
12034096|NCT00332176|Drug|Celgosivir|400mg qd + standard of care for 12 weeks
12034097|NCT00332176|Drug|Celgosivir|600mg qd + standard of care for 12 weeks
12034098|NCT00332176|Drug|Peginterferon alfa 2b + ribavirin|Standard of care for 12 weeks
12034099|NCT00332163|Biological|Panitumumab|Administered by intravenous infusion
12034100|NCT00332163|Drug|Irinotecan|Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines.
12034101|NCT00332163|Drug|FOLFIRI|Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.
12034102|NCT00332163|Drug|Pre-emptive Skin Treatment|Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily).
12034103|NCT00332163|Drug|Reactive Skin Treatment|Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)
12034104|NCT00332137|Drug|Tolterodine|
12034105|NCT00332124|Drug|Choline|900 mg every day until birth of infant
12034106|NCT00332124|Dietary Supplement|Placebo|Corn oil every day in place of choline
12034107|NCT00332098|Behavioral|Family-Focused Treatment Plus Pharmacotherapy|Participants assigned to FFT will take part in weekly treatment sessions with their families for 12 weeks, biweekly for 12 weeks, monthly for 3 months, and then trimonthly until Month 24. Medications used for the pharmacotherapy portion of the study will include mood stabilizers, such as lithium or divalproex sodium, and atypical antipsychotics, such as quetiapine. Participants will also receive anti-anxiety medications, psychostimulants, or antidepressants as needed.
12034108|NCT00332098|Behavioral|Enhanced Care Plus Pharmacotherapy|Participants assigned to Enhanced Care will take part in weekly brief psychoeducation sessions for 3 weeks. The pharmacotherapy treatment will be the same as for the FFT participants.
12034109|NCT00332085|Drug|Chromium Picolinate|
12034110|NCT00332072|Drug|bimatoprost/timolol fixed combination|
12034111|NCT00332059|Drug|bimatoprost/timolol fixed combination|
12034112|NCT00332046|Drug|GW679769|
12034113|NCT00332033|Drug|Pirfenidone|
12034114|NCT00332020|Drug|Rivaroxaban (BAY59-7939)|10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
12034115|NCT00332020|Drug|Enoxaparin|40 mg enoxaparin syringe administered for 12 +/- 2 days
12034116|NCT00332007|Drug|Tonabersat|two tablets once daily
12034117|NCT00332007|Drug|Placebo|two tablets once daily
12034118|NCT00331994|Drug|Bacillus clausii|3 bacillus clausii vials/day for one month
12034119|NCT00331994|Drug|Metronidazole|3 Metronidazole tablets/day for one week
12034120|NCT00331981|Drug|Amisulpride|
12034121|NCT00331955|Drug|doxorubicin hydrochloride|Given IV
12034122|NCT00331955|Drug|vorinostat|Given orally
12034123|NCT00331955|Other|pharmacological study|Correlative studies
12034124|NCT00331955|Other|laboratory biomarker analysis|Correlative studies
12034125|NCT00331929|Device|Minato A 500 AS spirometer|Spirometry at rest
12034126|NCT00331916|Drug|quinolone|
12034127|NCT00331890|Drug|Citicoline|1g/12h iv during 3 days and then orally until complete 6 weeks of treatment
12034128|NCT00331890|Drug|Placebo|As active drug
12034129|NCT00331877|Procedure|family conference with bereavement information leaflet|
12034130|NCT00331864|Drug|Ranibizumab|
12034131|NCT00331851|Drug|liraglutide|
12034132|NCT00331851|Drug|insulin glargine|
12034133|NCT00331851|Drug|metformin|
12034134|NCT00331851|Drug|glimepiride|
12034135|NCT00331838|Drug|Semuloparin sodium|"0.8 mL solution in Type I amber glass vials
~Subcutaneous injection"
12034136|NCT00331838|Drug|Placebo (for Enoxaparin sodium)|"0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component
~Subcutaneous injection"
12034137|NCT00331838|Drug|Enoxaparin sodium|"0.4 mL solution in ready-to-use pre-filled syringe
~Subcutaneous injection"
12034138|NCT00331838|Drug|Placebo (for Semuloparin sodium)|"0.8 ml solution in type I amber glass vials strictly identical in appearance containing the same volume but without active component
~Subcutaneous injection"
12034139|NCT00331825|Drug|Risperidone and Olanzapine|
12034140|NCT00331812|Procedure|Mitochondrial functions and oxidative stress|
12034141|NCT00331799|Drug|Duloxetine|Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.
12034142|NCT00331786|Drug|nitric oxide-releasing acetylsalicylic acid derivative|
12034143|NCT00331786|Other|laboratory biomarker analysis|
12034144|NCT00331786|Procedure|biopsy|
12034145|NCT00331773|Radiation|Conventional 3D-CRT or IMRT|Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
12034146|NCT00331773|Radiation|Hypofractionated 3D-CRT or IMRT|Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
12034147|NCT00331760|Drug|cisplatin|
12034148|NCT00331760|Radiation|intensity-modulated radiation therapy|
12034149|NCT00331747|Drug|Glatiramer acetate|
12034150|NCT00331721|Drug|Enecadin|Dose escalating
12034151|NCT00331721|Drug|Placebo|Placebo comparator
12034152|NCT00331708|Drug|Artesunate plus sulfadoxine-pyrimethamine|
12034153|NCT00331695|Drug|17 alpha-hydroxyprogesterones caproate|17 alpha-hydroxyprogesterones caproate
12034154|NCT00331682|Drug|alvocidib|Given IV
12034155|NCT00331682|Drug|docetaxel|Given IV
12034156|NCT00331669|Procedure|deep brain stimulation|high frequency stimulation
12034157|NCT00331656|Device|Non-invasive positive pressure mask ventilators|
12034158|NCT00331656|Device|Extrathoracic biphasic cuirass ventilator (RTX, Hayek)|
12034159|NCT00331643|Drug|ixabepilone|Given IV
12034160|NCT00331630|Drug|lapatinib ditosylate|Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
12034161|NCT00331630|Drug|paclitaxel albumin-stabilized nanoparticle formulation|30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
12034162|NCT00331604|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
12034163|NCT00331604|Drug|insulin detemir|Injection s.c., 50% of daily dose.
12034164|NCT00331604|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c.
12034165|NCT00331604|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c. After 2 years.
12034166|NCT00331578|Device|Excel drug-eluting coronary artery stent|
12034167|NCT00331565|Procedure|Bariatric surgery|Gastric bypass, duodenal switch and sleeve surgery
12034168|NCT00331552|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
12034169|NCT00331552|Drug|cyclophosphamide|Given orally
12034170|NCT00331552|Biological|trastuzumab|Given IV
12034171|NCT00331539|Device|Cochlear Implant|
12034172|NCT00331526|Biological|aldesleukin|
12034173|NCT00331526|Biological|therapeutic autologous lymphocytes|
12034174|NCT00331526|Procedure|adjuvant therapy|
12034175|NCT00331526|Procedure|conventional surgery|
12034176|NCT00331513|Drug|vorinostat|Given orally
12034177|NCT00331513|Drug|idarubicin|Given IV
12034178|NCT00331513|Other|laboratory biomarker analysis|Correlative studies
12034179|NCT00331513|Other|pharmacological study|Correlative studies
12034180|NCT00331500|Drug|Olopatadine Hydrochloride Ophthalmic Solution, 0.2%|
12034181|NCT00331500|Drug|Olopatadine Hydrochloride Ophthalmic Solution Vehicle|Inactive ingredients used as a placebo comparator
12034182|NCT00331487|Drug|Pioglitazone|Pioglitazone 30 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to pioglitazone 45 mg, capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks
12034183|NCT00331487|Drug|Rosiglitazone|Rosiglitazone 4 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to rosiglitazone 4 mg, capsules, orally, twice daily for up to 12 weeks
12034184|NCT00331474|Biological|BCG delayed|early (birth) and delayed (14 weeks) intradermal BCG vaccination
12034185|NCT00331435|Procedure|Ocular photodynamic therapy with verteporfin|Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
12034186|NCT00331422|Drug|carboplatin|Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes.
12034187|NCT00331422|Drug|paclitaxel|Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours.
12034188|NCT00331422|Procedure|cytoreductive surgery|Surgery - tumor specimen collected for extreme drug resistant assay (EDR) and A1 assays for analysis
12034189|NCT00331409|Drug|Everolimus|2.5 mg by mouth daily
12034190|NCT00331409|Drug|imatinib mesylate|600 mg by mouth daily
12034191|NCT00331370|Behavioral|GP training and Health Education|
12034192|NCT00331344|Drug|mitoxantrone hydrochloride|Given IV
12034193|NCT00331344|Drug|ixabepilone|Given IV
12034194|NCT00331344|Drug|prednisone|Given orally
12034195|NCT00331305|Behavioral|Supervised Exercise|
12034196|NCT00331305|Behavioral|Home-Based Exercise|
12034197|NCT00331305|Drug|Sertraline (Zoloft)|
12034198|NCT00331305|Drug|Placebo Pill|
12034199|NCT00331279|Drug|Oral Cinnamon Extract|A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.
12034200|NCT00331279|Drug|Placebo|Placebo pills in likeness of the cinnamon extract
12034201|NCT00331253|Procedure|Indocyanine Green-Mediated Photothrombosis|
12034202|NCT00331240|Drug|travoprost/timolol fixed combination|
12034203|NCT00331240|Drug|placebo (artificial tears)|
12034204|NCT00331227|Drug|Isotonix OPC-3 (flavonoid supplement)|
12034205|NCT00331214|Drug|Testosterone Transdermal System|testosterone patch (300 mcg/day), patch changed twice a week for six months
12034206|NCT00331214|Drug|placebo patch|placebo patch replaced every 3-4 days for 6 months
12034207|NCT00331201|Drug|SAFEstart|
12034208|NCT00331188|Drug|Sanvar® (vapreotide)|
12034209|NCT00331175|Drug|Peptide YY3-36|
12034271|NCT00330720|Device|Emergency Response System (Device)|
12034210|NCT00331162|Drug|Alemtuzumab|30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
12034211|NCT00331162|Drug|Anti-Thymocyte Globulin|"1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr < 3-4 mg/dL.
~Give first dose over 6 hours, subsequent doses over 4 hours.
~Premedication to be given with the first 3 doses:
~Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
~Hold infusion if temperature > 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours"
12034212|NCT00331149|Drug|Ropinirole prolonged release|
12034213|NCT00331149|Drug|ropinirole immediate release|
12034214|NCT00331136|Drug|Pyronaridine-Artesunate|once a day for 3 days
12034215|NCT00331123|Drug|Testosterone Transdermal System|testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks
12034216|NCT00331123|Drug|Placebo|placebo patch,changed every 3-4 days for 24 weeks during double blind phase
12034217|NCT00331110|Device|Laterally-Wedged Insole with Ankle Strapping|
12034218|NCT00331110|Device|Laterally-Weged Insole|
12034219|NCT00331097|Drug|docetaxel|35 mg/m2 intravenously on days 1, 8, and 15 every 28 days
12034220|NCT00331097|Drug|cyclophosphamide|600 mg/m2 intravenously days 1, 8 every 28 days
12034221|NCT00331097|Drug|methotrexate|40 mg/m2 intravenously days 1 and 8 every 28 days
12034222|NCT00331097|Drug|5-fluorouracil|600 mg/m2 intravenously days 1 and 8 every 28 days
12034223|NCT00331084|Drug|antibiotic/steroid combination|1 gtt, 4x/day, 15 days
12034224|NCT00331084|Drug|moxifloxacin / dexamethasone|1 gtt 4x/day, 15 days
12034225|NCT00331071|Drug|Monophasic or triphasic Oral contraceptive tablet|fourth week is patch free
12034226|NCT00331071|Drug|Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE|worn for 1 week and replaced for 3 consecutive weeks
12034227|NCT00331058|Procedure|Bronchoscopsy|Healthy and Asthmatic Volunteers
12034228|NCT00331058|Procedure|Prednisolone|Asthmatic Volunteers
12034229|NCT00331045|Drug|alvimopan|0.25 mg/day
12034230|NCT00331045|Drug|Placebo|
12034231|NCT00331045|Drug|Alvimopan 0.5 mg/day|
12034232|NCT00331045|Drug|Alvimopan 1 mg/day|
12034233|NCT00331032|Drug|3% w/w SPL7013 Gel|Twice-daily vaginal application of 3.5 g of VivaGel™ (Carbopol®-based gel with 3% w/w SPL7013) in single use pre-filled applicators.
12034234|NCT00331032|Drug|Placebo|Placebo gel (Carbopol®-based formulation alone) in single use pre-filled applicators.
12034235|NCT00331006|Drug|Rituximab|Rituximab by slow intravenous infusion; for participants greater than or equal to 10 kg, 375 mg per m^2 BSA weekly for 4 weeks; for participants less than 10 kg, 12.5 mg/kg weekly for 4 weeks
12034236|NCT00330993|Drug|mifepristone, misoprostol|
12034237|NCT00330980|Drug|40 mg Pravastatin (Pravachol)|Participants will receive 40 mg of pravastatin for 6 months.
12034238|NCT00330980|Drug|20 mg Simvastatin|Participants will receive 20 mg of simvastatin for 6 months.
12034239|NCT00330980|Drug|Placebo|Participants will receive placebo for 6 months.
12034240|NCT00330967|Drug|20% Intralipid|lipid infusion
12034241|NCT00330941|Drug|lidocaine|
12034242|NCT00330928|Device|Near Infrared Spectroscopy (NIRS) Imaging|Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
12034243|NCT00330928|Device|intravascular ultrasound (IVUS)|Ultrasound coronary catheter is positioned on a guidewire that has been placed in the coronary artery.Ultrasound imaging provides structural information about the vessel wall and blockages contained. It takes approximately 5 minutes to prepare, position, and to collect data with the catheter.
12034244|NCT00330915|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
12034245|NCT00330902|Drug|sulfadoxine-pyrimethamine (SP) plus artesunate (AS)|sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
12034246|NCT00330902|Drug|primaquine (PQ) plus SP+AS|single dose of primaquine on day 4
12034247|NCT00330876|Drug|Pitavastatin|
12034248|NCT00330863|Drug|Risperidone microspheres|Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
12034249|NCT00330863|Drug|Risperidone|Target dose is 4 mg/day.
12034250|NCT00330863|Drug|Olanzapine|Target dose is 15 mg/day.
12034251|NCT00330863|Drug|Quetiapine|Target dose is 600 mg/day.
12034252|NCT00330863|Drug|Ziprasidone|Target dose is 120 mg/day.
12034253|NCT00330863|Drug|Aripiprazole|Target dose is 20 mg/day.
12034254|NCT00330863|Drug|Paliperidone|Target dose is 6 mg/day.
12034255|NCT00330850|Drug|PRO-513|
12034256|NCT00330824|Drug|antibiotic/steroid combination|1gtt, 4x/d, 15 days
12034257|NCT00330824|Drug|moxifloxacin/dexamethasone|1gtt, 4x/days, 15 days
12034258|NCT00330798|Drug|nepafenac 0.1%|Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.
12034259|NCT00330798|Other|ketorolac 0.4%|Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.
12034260|NCT00330785|Drug|Amlodipine/Atorvastatin|
12034261|NCT00330772|Drug|Aspirin|
12034262|NCT00330772|Drug|Clopidogrel|
12034263|NCT00330759|Biological|Denosumab|120 milligrams by subcutaneous injection every 4 weeks
12034264|NCT00330759|Drug|Zoledronic Acid|4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks
12034265|NCT00330746|Drug|cetuximab|400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression
12034266|NCT00330746|Drug|gemcitabine|1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles
12034267|NCT00330746|Drug|gemcitabine|1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles
12034268|NCT00330746|Drug|cetuximab|400 mg/m2 first dose followed by 250 mg/m2 weekly
12034269|NCT00330733|Drug|Salsalate|Participants were randomized to 12-week treatment with up to 4 g/day.
12034270|NCT00330733|Drug|Placebo|Participants were randomized to 12-week treatment matching the active salsalate arm.
12034272|NCT00330707|Drug|Bacillus Calmette Guerin and interferon alpha|
12034273|NCT00330694|Other|ParkNet|Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.
12034274|NCT00330694|Other|Usual Care|No altered organisation of physiotherapy care in Parkinson's Disease
12034275|NCT00330681|Drug|MCI-186|Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
12034276|NCT00330681|Drug|Placebo of MCI-186|Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
12034277|NCT00330668|Drug|rh IGF-1 (mecasermin)|Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 µg/kg, escalated to a targeted maximum dose of 240 µg/kg.
12034278|NCT00330655|Drug|memantine|
12034279|NCT00330629|Behavioral|Standard Behavioral Treatment|Participants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products.
12034280|NCT00330629|Behavioral|SBT+LOV|The focus will be on the elimination of meat products as a means to reduce fat intake.
12034281|NCT00330616|Drug|323U66 SR|
12034282|NCT00330603|Procedure|Serial exhaled breath collections|collect breath for 5 minutes on 8 occasions
12034283|NCT00330577|Drug|timolol maleate 0.5%|
12034284|NCT00330577|Drug|latanoprost/timolol fixed combination|
12034285|NCT00330577|Drug|placebo (artificial tears)|
12034286|NCT00330564|Drug|SU011248|50 mg/day orally for 4 weeks, no treatment for 2 weeks (6 weeks = 1 cycle).
12034287|NCT00330551|Drug|Oral Risperidone|Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.
12034288|NCT00330551|Drug|Risperidone in Long-Acting Injectable Form (Consta)|Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.
12034289|NCT00330525|Drug|sibutramine|
12034290|NCT00330499|Drug|Cisplatin|Weekly Cisplatin 35mg/m2 x 6 doses, IV administration
12034291|NCT00330499|Radiation|External beam radiation treatment|64Gy reference dose in 32 fractions over 6.5 weeks
12034292|NCT00330486|Drug|Acamprosate|
12034293|NCT00330473|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)
12034294|NCT00330473|Drug|Insulin|patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)
12034295|NCT00330460|Drug|Alendronate|ALN; 70 mg; oral; once weekly
12034296|NCT00330460|Drug|Denosumab|60 mg; SC; every 6 months
12034297|NCT00330434|Other|Trial Withdrawn 1|Trial Withdrawn 1
12034298|NCT00330434|Other|Trial Withdrawn 2|Trial Withdrawn 2
12034299|NCT00330421|Drug|sorafenib tosylate|Given PO
12034300|NCT00330421|Procedure|therapeutic conventional surgery|Undergo surgery
12034301|NCT00330421|Other|laboratory biomarker analysis|Correlative studies
12034302|NCT00330421|Other|pharmacological study|Correlative studies
12034303|NCT00330421|Procedure|computed tomography|Correlative studies
12034304|NCT00330421|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Correlative studies
12034305|NCT00330408|Behavioral|GP training|
12034306|NCT00330395|Drug|caspofungin acetate|Duration of Treatment 28 Days
12034307|NCT00330382|Drug|Bowman-Birk inhibitor concentrate|Given orally
12034308|NCT00330382|Other|placebo|Given orally
12034309|NCT00330382|Other|laboratory biomarker analysis|Correlative studies
12034310|NCT00330369|Drug|Darusentan|Darusentan administered orally once daily
12034311|NCT00330369|Drug|Darusentan Placebo|Placebo to match darusentan administered orally once daily
12034312|NCT00330356|Behavioral|Low Salt Diet versus High salt diet|
12034313|NCT00330343|Drug|naloxone|continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour
12034314|NCT00330330|Drug|ISIS 113715|
12034315|NCT00330317|Drug|letrozole|2.5mg letrozole once-daily
12034316|NCT00330304|Drug|Isoniazid|isoniazid 10mg/kg orally, daily, for study period
12034317|NCT00330304|Drug|Cotrimoxazole|Cotrimoxazole given 3 times a week or daily, orally, for study period
12034318|NCT00330304|Drug|isoniazid|Isoniazid, 10mg/kg daily for study period
12034319|NCT00330304|Other|placebo|Placebo tablet identicle in appearance to intervention: isoniazid table
12034320|NCT00330291|Drug|Xyrem|
12034321|NCT00330278|Drug|Cefazolin|
12034322|NCT00330265|Device|KC-002|Determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
12034323|NCT00330265|Other|Conventional Wound Therapy|Normal Saline Dressings
12034324|NCT00330252|Drug|Rituximab|Given intravenously on day 1 of every week for eight weeks (or 16 weeks)
12034325|NCT00330252|Drug|Alemtuzumab|Drug: Alemtuzumab Dosage will vary during Phase I of trial: Given intravenously on days 1, 3, and 5 for weeks one and two, on days 1 and 4 for weeks three and four and on day 1 for weeks five through eight. Participants may receive either one eight-week course of treatment or two eight-week courses of treatment (16 weeks).
12034326|NCT00330239|Drug|Paroxetine CR|
12034327|NCT00330213|Behavioral|red wine and cognac consumption|
12034328|NCT00330200|Drug|ISIS 113715|
12034329|NCT00330187|Drug|Bupropion SR|Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
12034330|NCT00330187|Behavioral|Contingency Management|Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
12034331|NCT00330187|Other|Placebo|Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
12034332|NCT00330174|Drug|Acamprosate|2 333mg tablets three times daily
12034333|NCT00330161|Drug|vorinostat|Given orally
12034334|NCT00330161|Other|laboratory biomarker analysis|Correlative studies
12034335|NCT00330148|Drug|melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d|
12034336|NCT00330148|Drug|melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d|
12034337|NCT00330148|Drug|nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d|
12034338|NCT00330135|Drug|Sodium hyaluronate|Sodium hyaluronate 2.5 ml - 1 injection
12034339|NCT00330135|Drug|placebo injection|placebo injection - 1 injection
12034340|NCT00330122|Procedure|fore locked plate|
12034341|NCT00330122|Procedure|external radiocarpal fixer|
12034342|NCT00330109|Procedure|MRS Imaging|Performed on a 3.0 Tesla Philips Intera MRI Unit (Best, Netherlands). Scout views and T2 transverse images are obtained to locate the tumor in conjunction with any previous diagnostic images.
12034343|NCT00330109|Procedure|PET Scanning|Using an Allegro scanner, the patient will be scanned for approximately 20-30 minutes. All emission scan data is processed by a multi-step procedure.
12034344|NCT00330109|Procedure|Diffusion Tensor Imaging|Subjects will be scanned with a 3T Philips Intera MRI scanner for approximately 26 minutes for anatomical and DTI imaging. Total DTI acquisition time will be 6:06 minutes with 40 contiguous axial slices for full brain coverage.
12034345|NCT00330096|Drug|Hesperidin|
12034346|NCT00330096|Other|Placebo|
12034347|NCT00330083|Biological|ALK Ragweed Tablet|
12034348|NCT00330070|Drug|IPL512,602 20 mg once daily|
12034349|NCT00330070|Drug|IPL512,602 Matching Placebo once daily|
12034350|NCT00330044|Drug|Premetrexed (Alimta)|
12034351|NCT00330044|Drug|Carboplatin|
12034352|NCT00330018|Drug|Valganciclovir|Valganciclovir
12034353|NCT00330018|Drug|Acyclovir|Acyclovir
12034354|NCT00330005|Behavioral|Group Psychotherapy|
12034355|NCT00329992|Behavioral|Brief Eclectic Psychotherapy for PTSD|16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
12034356|NCT00329979|Behavioral|vascular access site|Randomized vascular access site
12034357|NCT00329966|Biological|Surface Antigen, Inactivated, Influenza (form.2006-07)|
12034358|NCT00329940|Drug|Letrozole|
12034359|NCT00329927|Biological|Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07|
12034360|NCT00329914|Drug|Progesterone|Vaginal pessaries, 200 mg/day
12034361|NCT00329914|Drug|Placebo|Placebo pessaries containing peanut oil
12034362|NCT00329901|Biological|Meningococcal ACWY conjugate vaccine (MenACWY-CRM)|
12034363|NCT00329901|Biological|Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)|
12034364|NCT00329901|Biological|saline placebo|4.5 mg sodium chloride per 0.5 ml dose
12034365|NCT00329888|Procedure|Endoscopic papillary balloon dilatation|
12034366|NCT00329888|Procedure|Endoscopic sphincterotomy|
12034367|NCT00329862|Procedure|Laparoscopic Truncal Vagotomy|
12034368|NCT00329849|Biological|Meningococcal ACWY-CRM conjugate vaccine|MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.
12034369|NCT00329849|Biological|Meningococcal ACWY-PS polysaccharide vaccine|MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.
12034370|NCT00329836|Other|There are no interventions in the observational study. The symptom of allodynia was measured.|No intervention. Description of allodynia testing appears elsewhere in this document
12034371|NCT00329823|Drug|Etanercept sc 50mg per week for 12 weeks|
12034372|NCT00329810|Drug|Aripiprazole|Tablets, oral, 15 mg, once daily, 12 weeks.
12034373|NCT00329797|Dietary Supplement|Calcium|A single dose of 500 mg of elemental calcium orally each day for 3 years.
12034374|NCT00329797|Dietary Supplement|Zoledronic acid|Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.
12034375|NCT00329797|Radiation|radiation therapy|Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
12034376|NCT00329797|Drug|LHRH|LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
12034377|NCT00329797|Dietary Supplement|Vitamin D|400 IU (10μg), orally each day for 3 years.
12034378|NCT00329784|Biological|Peanut Consumption Group|Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
12034379|NCT00329771|Other|No intervention: We are testing for the presence of allodynia|We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.
12034380|NCT00329758|Drug|rosuvastatin|20 mg oral, during 10 days
12034381|NCT00329758|Drug|Placebo|
12034382|NCT00329745|Biological|Rotarix™|Oral administration, 2 doses
12034383|NCT00329745|Biological|Placebo|Oral administration, 2 doses
12034384|NCT00329732|Drug|0.5% bupivicaine and 2% lidocaine|The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache
12034385|NCT00329732|Drug|Saline placebo|matching volume of saline (placebo)
12034386|NCT00329719|Procedure|Conventional Surgery|Undergo surgery
12034387|NCT00329719|Other|Laboratory Biomarker Analysis|Correlative studies
12034388|NCT00329719|Drug|Sorafenib Tosylate|Given PO
12034389|NCT00329719|Drug|Temsirolimus|Given IV
12034390|NCT00329706|Procedure|FDG-PET brain scan|The difference in the two arms' interventions is the time at which the FDG-PET brain scan information is available for the subjects' managing physicians. Experimental arms will have an immediate release of the PET report, while the Active Comparator arms will have a delayed release of 2 years.
12034391|NCT00329693|Drug|Norprolac|Placebo
12034392|NCT00329693|Drug|Norprolac|Quinagolide
12034393|NCT00329693|Drug|Norprolac|Quinagolide
12034394|NCT00329693|Drug|Norprolac|Quinagolide
12034395|NCT00329680|Dietary Supplement|Eicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins|An enteral diet will be given in accordance with the caloric goal calculated by the Harris-Benedict equation x 1.3. The enteral diet will be provided for a period of 7 days or until death OR start of oral diet OR start of parenteral diet OR discharge from the ICU OR decision from the attending physician/family/patient to no longer participate in this clinical study
12034396|NCT00329680|Dietary Supplement|Standard ICU enteral diet, isocaloric to the study diet|Patients will receive this diet in a blinded way using the same dose regimen specified previously and used in the study group
12034397|NCT00329667|Device|EPIC|Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves
12034398|NCT00329654|Procedure|Phototherapy with the Embar® light therapy or sham irradiation|Phototherapy with the Embar® light therapy or sham irradiation is followed.
12034399|NCT00329641|Drug|carboplatin|Given IV
12034400|NCT00329641|Drug|paclitaxel|Given IV
12034401|NCT00329641|Drug|sorafenib tosylate|Given orally
12034402|NCT00329628|Drug|Rivaroxaban (BAY59-7939)|10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days
12034403|NCT00329628|Drug|Enoxaparin|Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days
12034404|NCT00329615|Drug|Insulatard, flexpen|
12034405|NCT00329602|Drug|Placebo|Matching Placebo
12034406|NCT00329602|Drug|Ropinirole|Ropinirole IR 0.25mg/day to 4mg/day for RLS
12034407|NCT00329589|Drug|Velcade (bortezomib)|
12034408|NCT00329576|Biological|Hepatitis B vaccine|
12034409|NCT00329563|Drug|Up to 2 liter infusion of cold 4 degree C normal saline|Patients randomized to field cooling will receive up to 2 liters of 4oC normal saline. Control patients will receive standard of care following resuscitation.
12034410|NCT00329550|Biological|Certolizumab pegol (CZP)|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.
12034411|NCT00329550|Biological|Certolizumab pegol (CZP)|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.
12034412|NCT00329550|Biological|Certolizumab pegol (CZP)|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol 400 mg at Weeks 0, 2 and 4.
12034413|NCT00329537|Drug|Sargramostim (Leukine)|Self-subcutaneous injection
12034414|NCT00329537|Drug|Placebo|Self-subcutaneous injection
12034415|NCT00329524|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if a maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectively, 7 days following the completion of the first treatment session.
12034416|NCT00329511|Drug|methyldopa vs. clonidine|Comparison of compliance
12034417|NCT00329511|Drug|clonidine patch|methyldopa 250 - 750 mg qid clonidine patch 0.1 - 0.4 mg q week
12034418|NCT00329498|Drug|L-Ascorbic Acid|
12034419|NCT00329485|Drug|CORvalen (D-Ribose)|
12034420|NCT00329472|Drug|gemcitabine, cisplatin|
12034421|NCT00329459|Drug|sumatriptan succinate/naproxen sodium|
12034422|NCT00329459|Drug|placebo|placebo to match
12034423|NCT00329446|Drug|Quetiapine Fumarate|
12034424|NCT00329446|Drug|Escitalopram oxylate|
12034425|NCT00329433|Drug|Desirudin (Iprivask™)|Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.
12034426|NCT00329433|Drug|Heparin|The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).
12034427|NCT00329420|Biological|Certolizumab pegol|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.
12034428|NCT00329420|Biological|Certolizumab pegol|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.
12034429|NCT00329420|Biological|Certolizumab pegol|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.
12034946|NCT00324831|Procedure|antibody therapy|
12034430|NCT00329407|Drug|Topiramate (Topamax)|Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM & 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM & 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM & 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM
12034431|NCT00329394|Drug|ketamine|Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient
12034432|NCT00329381|Drug|Xolair|Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
12034433|NCT00329381|Drug|Xolair|Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
12034434|NCT00329368|Biological|EC90 (KLH-FITC)|1.2mg in combination with adjuvant GPI-0100 administered subcutaneously, weekly for 4 consecutive weeks during the first treatment cycle, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
12034435|NCT00329368|Biological|GPI-0100|3.0mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first treatment cycle, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
12034436|NCT00329368|Drug|EC17 (Folate-FITC)|0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks followed by 2 observation weeks for each cycle.
12034437|NCT00329368|Drug|Interleukin-2|Low dose (7-12 MIU) IL-2 administered subcutaneously three times per week (MWF) for 3 consecutive weeks during the first cycle, 4 consecutive weeks during cycle 2 and additional cycles
12034438|NCT00329368|Drug|Interferon-alpha|3.0 MIU administered subcutaneously 3 times per week (MWF) for 3 consecutive weeks during the first cycle of treatment, then 3.0 MIU administered subcutaneously 3 times per week (MWF) for 4 weeks for cycle 2 and additional cycles.
12034439|NCT00329355|Drug|sumatriptan succinate/naproxen sodium|
12034440|NCT00329342|Behavioral|Occupational ergonomic training|Adequate postural habits in activities of daily living
12034441|NCT00329329|Drug|satraplatin and capecitabine|satraplatin and capecitabine dose escalated per the dosing scheme
12034442|NCT00329316|Drug|Crinone Gel 8%|
12034443|NCT00329303|Drug|Certolizumab Pegol (Cimzia®)|"Pharmaceutical Form: Solution for injection in pre-filled syringe
~Route of Administration: Subcutaneous use
~Dose and Administration details :
~2 x 1 mL Certolizumab Pegol at Week 0, followed by
~1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
~2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10"
12034444|NCT00329277|Procedure|perimetry|
12034445|NCT00329264|Drug|Quetiapine fumarate|
12034446|NCT00329251|Biological|Hepatitis A|
12034447|NCT00329251|Biological|Hepatitis B|
12034448|NCT00329251|Biological|Influenza|
12034449|NCT00329251|Biological|Pneumococcal|
12034450|NCT00329251|Biological|Tetanus-diphteria|
12034451|NCT00329251|Biological|Varicella|
12034452|NCT00329251|Biological|Measles-Mumps-Rubella|
12034453|NCT00329238|Drug|Dabigatran|Dabigatran 150 mg BID (twice daily)
12034454|NCT00329238|Drug|Warfarin|Warfarin dosed individually to maintain INR 2.0-3.0
12034455|NCT00329225|Drug|rosiglitazone|
12034456|NCT00329212|Drug|San Huang Xie Jin Tang|
12034457|NCT00329199|Behavioral|Attachment-Based Family Therapy|
12034458|NCT00329186|Drug|desvenlafaxine SR|
12034459|NCT00329186|Drug|venlafaxine ER|
12034460|NCT00329173|Drug|Rosuvastatin|
12034461|NCT00329173|Drug|Atorvastatin|
12034462|NCT00329160|Drug|Rosuvastatin|2.5-20 mg
12034463|NCT00329160|Drug|HMG CoA inhibitor|3-hydroxy-3-methylglutaryl-coenzyme A
12034464|NCT00329147|Drug|desvenlafaxine SR|
12034465|NCT00329147|Drug|desipramine|
12034466|NCT00329147|Drug|paroxetine|
12034467|NCT00329134|Drug|Administration of quinine sulphate taste-masked pellets|
12034468|NCT00329121|Drug|PEP005|
12034469|NCT00329108|Drug|ziprasidone hydrochloride|Ziprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day.
12034470|NCT00329108|Drug|olanzapine|Olanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day.
12034471|NCT00329095|Drug|travoprost, latanoprost, or bimatoprost|
12034472|NCT00329095|Drug|Additional ocular hypotensive medication|
12034473|NCT00329082|Drug|LY2062430|"100mg QW IV for 12 weeks
~100mg Q4W IV for 12 weeks
~400mg QW IV for 12 weeks
~400mg Q4W IV for 12 weeks"
12034474|NCT00329082|Drug|Placebo|5: Placebo QW IV for 12 weeks
12034475|NCT00329069|Drug|atorvastatin (drug)|
12034476|NCT00329056|Drug|MitoQ|Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
12034477|NCT00329043|Drug|LHRH Agonist|Intramuscular injection either monthly for 3 months or in a single 3-month dose.
12034478|NCT00329043|Drug|Sunitinib Malate|25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.
12034479|NCT00329043|Procedure|Radical Prostatectomy|Radical prostatectomy after completion of Sunitinib and LHRH agonist.
12034480|NCT00329030|Drug|Autologous transplantation using rituxan/BEAM|Rituxan 375 mg/m2 (Day -19 and Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
12034481|NCT00329030|Drug|Autologous transplantation using Bexxar/BEAM|Bexxar dosimetric dose 5 mCi (Day -19); Bexxar therapy dose 75 cGy TBD (Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
12034482|NCT00329017|Procedure|Fine needle aspiration|Fine needle aspiration
12034483|NCT00329004|Drug|BMS-690514|Tablets, Oral, up to 300 mg, once daily, up to 24 mos
12034484|NCT00328991|Device|duct tape occlusion therapy|
12034485|NCT00328978|Drug|Quetiapine|
12034486|NCT00328965|Drug|Lacidipine|Lacidipine 2, 4, 6mg
12034487|NCT00328939|Drug|ARIXTRA infusion|
12034488|NCT00328939|Drug|Enoxaparine infusion|
12034947|NCT00324831|Procedure|biological therapy|
12034489|NCT00328926|Drug|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and estradiol [E2] levels). Total duration will be of 3 treatment cycles.
12034490|NCT00328926|Drug|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
12034491|NCT00328926|Drug|Placebo|Placebo will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
12034492|NCT00328926|Drug|Recombinant human follicle stimulating hormone (r-hFSH)|Fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU will be administered subcutaneously for 7 days. After 7 days of treatment, if the subject response will suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
12034493|NCT00328926|Drug|Recombinant human chorionic gonadotropin (r-hCG)|When the follicular response will adequate, ovulation will be triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
12034494|NCT00328913|Drug|5-hydroxytryptophan (food supplement)|
12034495|NCT00328900|Drug|Administration of 0,7 mg of atropine|
12034496|NCT00328900|Device|Measurement of skin conductance with Pain detector|
12034497|NCT00328887|Genetic|CD40 Gene Transfer|gene transfer, intratumoral administration
12034498|NCT00328874|Drug|Coenzyme Q10|
12034499|NCT00328861|Drug|Natural Killer (NK) Lymphocytes|Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
12034500|NCT00328861|Biological|IL-2|IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days.
12034501|NCT00328861|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7.
12034502|NCT00328861|Drug|Fludarabine|Fludarabine 25 mg/m^2 day intravenous on days -6 through -2.
12034503|NCT00328848|Behavioral|Behavioral|Group Treatment(patient education, self management support, caregiver support)
12034504|NCT00328848|Behavioral|behavioral|patient education, self management support, caregiver support
12034505|NCT00328835|Procedure|Brief Elevation of IOP|
12034506|NCT00328822|Drug|Quetiapine|
12034507|NCT00328822|Drug|placebo|
12034508|NCT00328809|Drug|spironolactone|spironolactone administered to ESRD patients at low dose
12034509|NCT00328796|Procedure|acupuncture in 6 specific points|
12034510|NCT00328796|Drug|lidocaine 10mg/ml|
12034511|NCT00328783|Device|Active Breathing Coordinator (ABC)|The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
12034512|NCT00328783|Radiation|Radiation Therapy|
12034513|NCT00328770|Drug|Sirolimus|Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
12034514|NCT00328757|Behavioral|Regular diet as the first postoperative meal|
12034515|NCT00328744|Behavioral|Standard|18-month standard behavioral weight loss intervention
12034516|NCT00328744|Behavioral|Limited Variety|Two chosen snack foods
12034517|NCT00328731|Procedure|Procedure|
12034518|NCT00328718|Drug|montelukast (5mg QD)|
12034519|NCT00328718|Drug|Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)|
12034520|NCT00328705|Device|Implantable Cardioverter Defibrillator|
12034521|NCT00328692|Drug|rolofylline|rolofylline 30 mg IV QD; 3 days
12034522|NCT00328692|Drug|Comparator: Placebo (unspecified)|rolofyline Pbo 30 mg IV QD; 3 days
12034523|NCT00328679|Device|in vitro and in vivo allergy testing|Patch Test: food to be tested is suspended in sterile saline, placed on the skin of the back using a Finn Chamber secured with surgical tape and left in place for 48 hours.
12034524|NCT00328666|Behavioral|Iyengar yoga|
12034525|NCT00328666|Behavioral|Enhanced nutritional care classes|
12034526|NCT00328653|Drug|cyclosporine|
12034527|NCT00328640|Drug|Optimal treatment|
12034528|NCT00328627|Drug|Alogliptin|Alogliptin tablets.
12034529|NCT00328627|Drug|Alogliptin placebo|Alogliptin placebo-matching tablets.
12034530|NCT00328627|Drug|Pioglitazone|Pioglitazone tablets.
12034531|NCT00328627|Drug|Pioglitazone placebo|Pioglitazone placebo-matching tablets.
12034532|NCT00328614|Drug|Samarium-153|Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD).
12034533|NCT00328614|Drug|Total Androgen Suppression (TAS) with Bicalutamide|Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
12034534|NCT00328614|Drug|Total androgen suppression (TAS) with Goserelin Acetate|Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
12034535|NCT00328614|Device|Radiation Therapy|Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks.
12034536|NCT00328601|Drug|Thioctic Acid|
12034537|NCT00328588|Drug|YM155|IV
12034587|NCT00328042|Behavioral|Self-Management Workshop|The workshop is a once per week 2.5 hour group that meets for six weeks.
12034588|NCT00328042|Behavioral|Information Only|This is an individual self-paced at home study program.
12034589|NCT00328029|Drug|busulfan|5mg/kg/day (oral route : 4 doses/day for 4 days)
12034948|NCT00324831|Procedure|chemotherapy|
12034538|NCT00328575|Radiation|Intensity-Modulated Radiotherapy (IMRT)|"The duration of radiation therapy will be total of 3 weeks. During the first week, all patients will be treated initially with whole brain radiation therapy (WBRT) at 2.5Gy per fraction daily 5 days a week to a dose of 12.5Gy. This will be delivered through parallel-opposed fields to cover the entire cranial contents.
~For the remaining 2 weeks, patients will be treated using intensity-modulated radiation therapy (IMRT) technology such that a higher dose can be delivered to the tumor. IMRT is capable of generating complex 3-D dose distribution to conform closely to the target volume by modulating the radiation beam. This process is based on the inverse method of treatment planning to optimize radiation dose to tumor target coverage and normal tissue sparing."
12034539|NCT00328562|Drug|ZD1839 (Iressa)|
12034540|NCT00328562|Radiation|Thoracic Radiotherapy|
12034541|NCT00328549|Drug|Pegylated Interferon and Ribavirin|
12034542|NCT00328536|Drug|Omacor|
12034543|NCT00328523|Drug|MK-0653, ezetimibe|
12034544|NCT00328523|Drug|Duration of Treatment: 3 months|
12034545|NCT00328510|Device|GTC frame|
12034546|NCT00328510|Device|Thermoplastic facemask|
12034547|NCT00328510|Radiation|Stereotactic radiation therapy|
12034548|NCT00328497|Drug|Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)|Panzem NCD 1,000 mg, four times daily for 28 consecutive days bevacizumab 5 mg/kg intravenous bolus on Day 1 and Day 15
12034549|NCT00328484|Behavioral|Lifestyle Activity Program|The lifestyle activity program will consist of 35 exercise and counseling sessions spaced over 11 months. This program will use cognitive-behavioral strategies to encourage physical activity at home. Participants will receive information on how to deal with COPD symptoms (including shortness of breath), goal-setting, social support, and motivation. Participants will also receive follow-up telephone calls from the program staff for additional support.
12034550|NCT00328484|Behavioral|Exercise Program|The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.
12034551|NCT00328471|Behavioral|care management|
12034552|NCT00328458|Drug|EPO906 (epothilone B)|
12034553|NCT00328445|Behavioral|Positive Action|See publications
12034554|NCT00328432|Drug|celecoxib 400 mg bid|
12034555|NCT00328419|Device|photoprotected bags, tubing, syringes|use of photoprotected parenteral nutrition device
12034556|NCT00328419|Device|standard tubing and bags|Use of standard (transparent) parenteral nutrition device
12034557|NCT00328393|Drug|Pioglitazone|45 mg 8 weeks
12034558|NCT00328393|Drug|Placebo|Placebo
12034559|NCT00328380|Drug|Rifaximin|
12034560|NCT00328367|Drug|aripiprazole|aripiprazole augmentation of clozapine
12034561|NCT00328367|Drug|placebo|placebo
12034562|NCT00328302|Drug|Candesartan|
12034563|NCT00328302|Drug|Placebo|
12034564|NCT00328289|Device|transcutaneous muscle stimulation, treadmill|
12034565|NCT00328276|Drug|Sarcosine|
12034566|NCT00328263|Dietary Supplement|Lactobacillus acidophilus CL1285 and Lactobacillus casei|One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
12034567|NCT00328263|Dietary Supplement|placebo|One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
12034568|NCT00328250|Behavioral|Cognitive behavioral treatment (CBT) delivered over the Internet|CBT delivered over the Internet for insomnia targets maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems. Treatment includes through educational, behavioral, and cognitive strategies.
12034569|NCT00328237|Procedure|Cord Blood Transplant|
12034570|NCT00328211|Dietary Supplement|Bile Acids (Cholic, Ursodeoxycholic, Chenodeoxycholic)|15 mg/kg/day for 18 days
12034571|NCT00328211|Dietary Supplement|Sphingomyelin|1000mg/day for 19 days
12034572|NCT00328211|Other|C13 Stable isotope of Cholesterol|Food provided for 3 days and one time dose of 113mg of C13 Cholesterol.
12034573|NCT00328198|Biological|Alemtuzumab|"Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). When escalation to 30 mg is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks.
~Part 1 of the study: The first 20 patients will be randomized to either Arm 1 (dose escalation) or Arm 2 (no escalation). Part 1 of the study has been completed; no additional patients will be enrolled in Part 1. An assigned review panel has reviewed the safety data from Part 1 and determined that all patients will be enrolled and treated under a no escalation schedule for Part 2 of the study."
12034574|NCT00328198|Biological|Alemtuzumab|"Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks.
~Part 2 of the study: All patients are currently being enrolled under the no escalation schedule for Part 2 of the study. All patients in Part 2 will be treated with 30mg of alemtuzumab (with no escalation period) administered SC (at alternating injection sites) 3 times per week (e.g., Monday, Wednesday, Friday) for up to 18 weeks. Alemtuzumab is to be administered in a supervised medical setting on an outpatient basis for the first three weeks, after which some study centers may allow a home administration option, with one weekly clinic visit. Under the home administration option, alemtuzumab may be administered by the patient or care giver if the patient meets conditions specified in the protocol guidelines for home administration."
12034575|NCT00328172|Drug|Placebo|Placebo matching BI 1356
12034576|NCT00328172|Drug|BI 1356 dose 3 once daily|BI 1356 dose 3 once daily
12034577|NCT00328172|Drug|BI 1356 dose 2 once daily|BI 1356 dose 2 once daily
12034578|NCT00328172|Drug|BI 1356 dose 1 once daily|BI 1356 dose 1 once daily
12034579|NCT00328172|Drug|Metformin|Metformin
12034580|NCT00328159|Drug|Oil special 107 and MYGLIOL 810|
12034581|NCT00328146|Other|Observation of sternal reentry|Observation of sternal reentry
12034582|NCT00328120|Drug|Fulvestrant|500 mg intramuscular injection
12034583|NCT00328107|Biological|Influenza Vaccine, recombinant Hemagglutinin|0.5mL dose for IM injection
12034584|NCT00328094|Drug|continuous intravenous insulin infusion|Tight glucose control versus standard of care
12034585|NCT00328055|Behavioral|AD-Easy (Advance Directive-Easy)|
12034586|NCT00328055|Behavioral|AD-Standard (Advance Directive-Standard)|
12034590|NCT00328029|Procedure|respiratory function tests|respiratory function tests before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
12034591|NCT00328029|Procedure|pharmacokinetics, done during the treatment|"12 blood collections :
~after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h.
~3 hours after 2nd taken of Busulfan
~3 hours after 3rd taken of Busulfan
~3 hours after 4th taken of Busulfan
~3 hours after 5th taken of Busulfan
~3 hours after 6th taken of Busulfan."
12034592|NCT00328016|Behavioral|Guided Breathing|The participant will engage in daily 15 min sessions of meditative relaxation that involves quiet attention to breathing pattern with no attempt to manipulate breathing pattern
12034593|NCT00328016|Device|RESPeRATE|The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones
12034594|NCT00327990|Drug|Ibandronate|
12034595|NCT00327990|Drug|Alendronate|
12034596|NCT00327938|Device|Measuring of skin conductance|
12034597|NCT00327938|Procedure|Tetanic stimuli|
12034598|NCT00327925|Procedure|Find Cancer Associated Antibodies|
12034599|NCT00327912|Procedure|Laparoscopic Biliopancreatic diversion with Duodenal switch|
12034600|NCT00327912|Procedure|Laparoscopic Roux-en-Y Gastric Bypass|
12034601|NCT00327873|Other|Oxygen|2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
12034602|NCT00327873|Other|Medical Air|2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
12034603|NCT00327847|Drug|Oral Vitamin D Supplementation|
12034604|NCT00327834|Drug|atomoxetine|
12034605|NCT00327821|Behavioral|calorie controlled diet|
12034606|NCT00327808|Drug|TPI-1020|600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
12034607|NCT00327808|Drug|budesonide|400 mcg BID x 14 days then 800 mcg/day x 7 more days
12034608|NCT00327769|Drug|Fulvestrant|250 mg intramuscular injection
12034609|NCT00327769|Drug|Anastrozole|1 mg tablet
12034610|NCT00327756|Drug|Coenzyme Q10|
12034611|NCT00327743|Drug|larotaxel|IV infusion on Day 1 of a 21-day cycle
12034612|NCT00327743|Drug|capecitabine|oral, twice daily, Day 1-Day 14 of a 21-day cycle
12034613|NCT00327730|Drug|Eperisone|
12034614|NCT00327717|Drug|Zonisamide|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
12034615|NCT00327717|Drug|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
12034616|NCT00327704|Drug|albumin|albumin 20% 100 ml/8 hours for 3 days
12034617|NCT00327704|Drug|saline|saline 100 ml/8hours for 3 days
12034618|NCT00327691|Drug|Atorvastatin|
12034619|NCT00327678|Drug|Rituximab|
12034620|NCT00327678|Drug|Imatinib Mesylate|
12034621|NCT00327665|Biological|11-valent pneumococcal vaccine GSK513026|Two-dose intramuscular injection. Each group receiving one of the 3 formulations
12034622|NCT00327665|Biological|Pneumo 23™|Single-dose intramuscular injection.
12034623|NCT00327665|Biological|Placebo|1 intramuscular injection.
12034624|NCT00327665|Biological|10-valent pneumococcal vaccine GSK513026|Two-dose intramuscular injection
12034625|NCT00327652|Drug|CRS-100|Live-attenuated Listeria monocytogenes
12034626|NCT00327626|Drug|ISIS 113715|
12034627|NCT00327600|Drug|imexon|
12034628|NCT00327600|Drug|DTIC|
12034629|NCT00327587|Drug|Valsartan + amlodipine|
12034630|NCT00327587|Drug|Valsartan + HCTZ|
12034631|NCT00327587|Drug|Amlodipine + HCTZ|
12034632|NCT00327587|Drug|Valsartan + amlodipine + HCTZ|
12034633|NCT00327574|Behavioral|Home heath education +/_ GP training|
12034634|NCT00327561|Procedure|Intensive periodontal therapy|
12034635|NCT00327561|Procedure|Community based periodontal therapy|
12034636|NCT00327548|Behavioral|guided imagery|
12034637|NCT00327535|Drug|Darbepoetin alfa|According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
12034638|NCT00327535|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|6.3 micrograms/kg every 3 weeks
12034639|NCT00327535|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|9 micrograms/kg every 3 weeks
12034640|NCT00327535|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|12 micrograms/kg every 3 weeks
12034641|NCT00327522|Biological|pneumococcal vaccine|
12034642|NCT00327496|Biological|DC vaccine|
12034643|NCT00327483|Behavioral|Internet based education software|
12034644|NCT00327470|Drug|Pegaptanib Sodium 0.3 mg|Pegaptanib Sodium dosed every 6 weeks in affected eye.
12034645|NCT00327457|Behavioral|Help with physician office and patient management|
12034646|NCT00327457|Behavioral|Tailored physician recommendation letter|
12034647|NCT00327444|Drug|aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.
12034648|NCT00327444|Drug|Placebo|Placebo was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.
12034649|NCT00327444|Drug|aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the OL period.
12034650|NCT00327431|Genetic|Cheek swab samples for DNA|
12034651|NCT00327418|Drug|Atorvastatin|
12034652|NCT00327392|Drug|AQUAVAN® (fospropofol disodium) Injection|
12034653|NCT00327379|Drug|Trasylol (Aprotinin, BAYA0128)|Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
12034654|NCT00327379|Drug|Placebo|Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
12034655|NCT00327366|Procedure|Light therapy|
12034656|NCT00327353|Drug|formoterol (TURBOHALER)|
12034657|NCT00327353|Drug|Salmeterol (DISKUS)|
12034832|NCT00325767|Drug|nebulized placebo (3ml/dose)|
12034658|NCT00327340|Drug|custirsen (OGX-011)/mitoxantrone|"All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to-1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21-day cycle.
~Mitoxantrone was administered IV on Day 1 of each cycle at a planned dose of 12 mg/m² infused over 30 minutes.
~Patients could receive a maximum of 9 cycles of treatment."
12034659|NCT00327340|Drug|custirsen (OGX-011)/docetaxel|"All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to -1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21 day cycle.
~Docetaxel was administered IV on Day 1 of each cycle at a planned dose of 75 mg/m² infused over 60 minutes.
~Patients could receive a maximum of 9 cycles of treatment."
12034660|NCT00327327|Drug|imexon|30-60 minutes IV, days 1,8,15 every 28 days
12034661|NCT00327327|Drug|gemcitabine|30 minutes IV, days 1,8,15 every 28 days
12034662|NCT00327314|Procedure|Transplantation|
12034663|NCT00327314|Procedure|Hematopoietic cell transplantation|
12034664|NCT00327288|Drug|imexon|IV variable dosages, days 1-5 every 21 days for duration of study
12034665|NCT00327288|Drug|docetaxel|IV once every 21 days for duration of study
12034666|NCT00327275|Behavioral|strength training|
12034667|NCT00327262|Drug|Imatinib|
12034668|NCT00327249|Drug|imexon|
12034669|NCT00327223|Drug|imexon|
12034670|NCT00327210|Behavioral|Blood Glucose Awareness Training|
12034671|NCT00327197|Drug|Prednisolone|Subjects will be administered oral prednisolone at a dose of 0.5 mg/kg, up to a maximum of 40 mg per day for 14 days.
12034672|NCT00327197|Procedure|Bronchoscopy|All subjects will undergo bronchoscopy assessments which will involve insertion of a standard bronchoscope.
12034673|NCT00327184|Biological|Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
12034674|NCT00327184|Biological|Infanrix Penta|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
12034675|NCT00327184|Biological|Infanrix hexa|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
12034676|NCT00327184|Biological|Neis-Vac-C|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
12034677|NCT00327171|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|"Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.
~Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
12034678|NCT00327171|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|"Aflibercept 2.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.
~Aflibercept could be reduced by 1 dose level (to 1.0 mg/kg) or 2 dose levels (to 0.5 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
12034679|NCT00327158|Procedure|Transesophageal transducer|One time use of reamer during surgery
12034680|NCT00327158|Procedure|echocardiography|takes photos of right atrium during the reaming processes
12034681|NCT00327145|Drug|valsartan|
12034682|NCT00327145|Drug|hydrochlorothiazide|
12034683|NCT00327145|Drug|amlodipine|
12034684|NCT00327132|Drug|Omeprazole, Amoxicillin, Clarithromycin|
12034685|NCT00327119|Drug|ABX-EGF (panitumumab)|
12034686|NCT00327106|Drug|Tranexamic acid (Exacyl)|15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
12034687|NCT00327106|Drug|Placebo|NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
12034688|NCT00327093|Drug|cetuximab|indication : second intention treatment
12034689|NCT00327093|Drug|bevacizumab|Indication: first intention treatment
12034690|NCT00327080|Procedure|MRI|
12034691|NCT00327080|Drug|L-NMMA|
12034692|NCT00327080|Drug|Acetylcholine|
12034693|NCT00327054|Drug|Nigella sativa seed|
12034694|NCT00327028|Drug|Diphenine|
12034695|NCT00327015|Drug|Saxagliptin|Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
12034696|NCT00327015|Drug|Saxagliptin|Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
12034697|NCT00327015|Drug|Metformin|Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
12034698|NCT00327015|Drug|Placebo|Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
12034699|NCT00327015|Drug|pioglitazone|Tablets, Oral, 15-45 mg, as needed (12 months LT)
12034700|NCT00327002|Drug|LY518674|
12034701|NCT00326989|Procedure|intracoronary stem cell therapy|extracorporal shock waves prior to intracoronary cell therapy
12034702|NCT00326976|Drug|FX06|400 mg as intravenous injection in two divided boluses
12034703|NCT00326976|Procedure|Percutaneous coronary intervention|
12034704|NCT00326963|Drug|Background ARVs|As prescribed
12034705|NCT00326963|Drug|PI|As prescribed
12034706|NCT00326963|Drug|enfuvirtide [Fuzeon]|90mg sc bid
12034707|NCT00326950|Drug|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2.
12034708|NCT00326924|Biological|Transfusion|PRBC blood transfusions.
12034709|NCT00326911|Biological|cetuximab|I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1
12034710|NCT00326911|Biological|bevacizumab|10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.
12034949|NCT00324831|Procedure|colony-stimulating factor therapy|
12034711|NCT00326911|Drug|gemcitabine|1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.
12034712|NCT00326911|Biological|cetuximab|I.V.infusions of 250 mg/m2 (over 60 minutes) weekly
12034713|NCT00326898|Other|Laboratory Biomarker Analysis|Correlative studies
12034714|NCT00326898|Other|Placebo|Given PO
12034715|NCT00326898|Other|Quality-of-Life Assessment|Ancillary studies
12034716|NCT00326898|Drug|Sorafenib Tosylate|Given PO
12034717|NCT00326898|Drug|Sunitinib Malate|Given PO
12034718|NCT00326885|Drug|catumaxomab|Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).
12034719|NCT00326872|Drug|Cediranib Maleate|
12034720|NCT00326859|Drug|remifentanil|
12034721|NCT00326833|Drug|vitamin B12|9 µg vitamin B12 three times daily for two days (CobaSorb)
12034722|NCT00326820|Drug|ibandronate sodium|
12034723|NCT00326820|Drug|zoledronic acid|
12034724|NCT00326820|Drug|Zolendronic Acid|Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
12034725|NCT00326807|Drug|Naltrexone|
12034726|NCT00326794|Procedure|mobilisation (rehabilitation)|
12034727|NCT00326781|Drug|Nicoderm Transdermal Patch|The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.
12034728|NCT00326781|Drug|Nicotine Nasal Spray|8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.
12034729|NCT00326768|Drug|Telmisartan 40 mg/HCTZ 12.5 mg|
12034730|NCT00326768|Drug|Telmisartan 40 mg|
12034731|NCT00326768|Drug|Telmisartan 80 mg/HCTZ 12.5 mg|
12034732|NCT00326742|Behavioral|Trier Social Stress Test|
12034733|NCT00326716|Drug|Atazanavir + Ritonavir + Combivir|Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
12034734|NCT00326703|Procedure|Hypobaric hypoxia|
12034735|NCT00326690|Device|Blue Egg Device|
12034736|NCT00326677|Behavioral|Problem Solving Therapy|6 to 8 Problem Solving Therapy sessions over the course of 6 to 16 weeks followed by 3 booster PST sessions over the course of 2 years
12034737|NCT00326677|Behavioral|Dietary Education|6 to 8 Diet Education sessions over the course of 6 to 16 weeks followed by 3 booster Diet Education sessions over the course of 2 years
12034738|NCT00326664|Drug|Cediranib Maleate|Given orally
12034739|NCT00326638|Radiation|Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy|"IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks
~Initial IMRT to Nodes/Prostate + Seminal Vesicles 4,600 cGy/23
~Boost IMRT to Prostate 3,200 cGy/16"
12034740|NCT00326638|Other|Arm A: 3D-Conformal Radiation|"3DCRT 7800 cGY/39 Fractions/ STD Technique* once daily Monday to Friday for 8 weeks
~Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
~Boost 6 F 3DCRT to Prostate 3,200 cGy/16"
12034741|NCT00326625|Drug|40 mg glatiramer acetate|parenteral drug
12034742|NCT00326625|Drug|Placebo|
12034743|NCT00326612|Drug|Midazolam|Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.
12034744|NCT00326612|Drug|Diazepam|Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
12034745|NCT00326599|Drug|carboplatin|Given IV
12034746|NCT00326599|Drug|cediranib maleate|Given orally
12034747|NCT00326599|Drug|gemcitabine hydrochloride|Given IV
12034748|NCT00326586|Drug|AR Antagonist (BMS-641988)|Tablets, Oral, 6 Patients will be randomized in a 1:1 ratio and in a double-blinded fashion to achieve a single dose of the study drug or Placebo on C1D1. Once daily, at least 3 cycles until the disease progresses
12034749|NCT00326573|Behavioral|Motivational Interviewing|
12034750|NCT00326560|Procedure|Pterygium excision and conjunctival autograft|
12034751|NCT00326508|Drug|Daclizumab|
12034752|NCT00326495|Drug|Cetuximab|Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
12034753|NCT00326495|Drug|BAY 43-9006|Is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro
12034754|NCT00326469|Drug|lanreotide (Autogel formulation)|120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
12034755|NCT00326456|Drug|liposomal doxorubicin|30 mg/m2 gieven intravenously on day 1 every 3 weeks
12034756|NCT00326456|Drug|carboplatin|AUC 5 intravenously on day 1 every 3 weeks
12034757|NCT00326456|Drug|paclitaxel|175 mg/m2 intravenously on day 1 every 3 weeks
12034758|NCT00326443|Biological|CVD 909|5 X 10^9 CFU of oral S. Typhi vaccine strain CVD 909 with buffer administered on Day 0.
12034759|NCT00326443|Drug|Placebo|Buffer placebo administered on Day 0.
12034760|NCT00326443|Biological|Vi Polysaccharide|25 micrograms (0.5 ml) of licensed purified Vi polysaccharide vaccine on Day 21.
12034761|NCT00326430|Behavioral|Cognitive Therapy, Interpersonal Therapy|
12034762|NCT00326417|Drug|Fludarabine|Doses of 30 mg/m^2 IV will be given for no less than 30 minutes daily for 4 days (Days -5 to -2)
12034763|NCT00326417|Drug|Cyclophosphamide 150mg|A total dose of 150 mg/kg will be given as 50 mg/kg per day for 3 days (Days -4, -3, -2)
12034764|NCT00326417|Drug|Cyclophosphamide 100mg|A total dose of 100 mg/kg will be given as 50 mg/kg per day for 2 days (Days -3, -2)
12034765|NCT00326417|Drug|Cyclophosphamide 50mg|A total dose of 50 mg/kg will be given once at 50 mg/kg per day on Day -2
12034833|NCT00325754|Device|E-Cylinder|Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
12034834|NCT00325754|Device|Lightweight Cylinder|Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
12034766|NCT00326404|Drug|Desogestrel-Ethinyl Estradiol 21 tablets|The participants in the continuous study arm will be given 4 packs of Marvelon-21, so that they can take the pills continuously for 84 days followed by no medication for 7 days. During these 7 days, the participant will have a withdrawal bleed. This sequence is repeated by the participant for a total of 12 months. Each patient in the continuous arm will have 4 withdrawal bleeds per year.
12034767|NCT00326404|Drug|Desogestrel-Ethinyl Estradiol 28 tablets|The participants in the cyclical arm of the study will be given 3 packs of Marvelon-28 and asked to take all the pills in the packet, including the placebo pills. During the week of placebo pills, these participants will have a withdrawal bleed. Each patient in the cyclical arm will have 12 withdrawal bleeds per year. The duration of study drug treatment for both arms is 12 months.
12034768|NCT00326391|Drug|methylphenidate hydrochloride extended-release tablets|
12034769|NCT00326378|Drug|consolidation chemotherapy with Docetaxel plus cisplatin|definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin
12034770|NCT00326378|Drug|CCRT arm without consolidation chemotherapy|definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy
12034771|NCT00326365|Drug|Kali bichromicum 10-60 (C30)|
12034772|NCT00326352|Drug|Sedation with propofol and remifentanil|
12034773|NCT00326339|Drug|R788|R788 50 mg, 100 mg, or 150 mg PO bid
12034774|NCT00326339|Drug|Placebo|Placebo PO bid
12034775|NCT00326326|Drug|CP-778,875|
12034776|NCT00326300|Drug|methylphenidate hydrochloride extended-release tablets|
12034777|NCT00326287|Drug|Ceftobiprole medocaril|
12034778|NCT00326287|Drug|Ceftriaxone with or without Linezolid|
12034779|NCT00326274|Drug|Helioblock® SX Cream|
12034780|NCT00326261|Procedure|Ultrasound compared to dual-endpoint nerve stimulator guided approach.|
12034781|NCT00326261|Procedure|Ultrasound|
12034782|NCT00326248|Drug|GW679769 (casopitant)|
12034783|NCT00326235|Drug|Buspirone|
12034784|NCT00326222|Behavioral|Lifestyle counseling|Self-management group education
12034785|NCT00326209|Drug|Encapsulated Mesalamine Granules (eMG)|eMG capsules will be administered per dose and schedule specified in the arm.
12034786|NCT00326196|Device|Percutaneous coronary intervention (PCI)|percutaneous coronary stenting with drug eluding stents
12034787|NCT00326196|Procedure|Coronary artery bypass graft (CABG)|coronary bypass
12034788|NCT00326183|Biological|VAQTA®|0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
12034789|NCT00326183|Biological|ProQuad|0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
12034790|NCT00326170|Drug|5-Azacytidine (5-aza)|Start at 75 mg/m^2 subcutaneously daily for 7 days.
12034791|NCT00326170|Drug|Valproic Acid|50 mg/kg daily by mouth for 7 days, same days as 5-aza.
12034792|NCT00326170|Drug|All-Trans Retinoic Acid (ATRA)|45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3 of the administration of 5-aza and VPA.
12034793|NCT00326157|Drug|AmBisome|3mg/kg/day three times a week until day 22 (21 days after transplantation day) and 7 mg/kg weekly from day 29 to the end of treatment (day 50-8th Week) of AmBisome®, IV administration
12034794|NCT00326144|Drug|Quetiapine fumarate|
12034795|NCT00326131|Drug|Oral Taxane|
12034796|NCT00326118|Biological|Haemophilus influenzae type b and meningococcal serogroup C (vaccine)|One intramuscular dose at 12-18 months of age
12034797|NCT00326118|Biological|Priorix™|One subcutaneous dose at 12-18 months of age
12034798|NCT00326118|Biological|Hiberix™|One intramuscular dose at 12-18 months of age.
12034799|NCT00326118|Biological|Meningitec™|One intramuscular dose at 12-18 months of age
12034800|NCT00326105|Drug|Quetiapine fumarate|
12034801|NCT00326092|Drug|Brinzolamide/Timolol|
12034802|NCT00326079|Device|Stent|implantation of 1 Glaukos iStent versus 2 Glaukos iStents
12034803|NCT00326066|Device|Glaucoma Surgery|Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.
12034804|NCT00326066|Procedure|cataract surgery only|Subjects will undergo routine cataract surgery only (no stent implant).
12034805|NCT00326053|Drug|Budesonide/formoterol|
12034806|NCT00326040|Device|Glaucoma Surgery|
12034807|NCT00326027|Drug|Pantoprazole|Efficacy of Pantoprazole
12034808|NCT00326014|Device|iStent|Glaucoma Surgery
12034809|NCT00326001|Device|Gold tip catheter|Radiofrquency ablation using gold tip catheter
12034810|NCT00326001|Device|Platinum-iridium tip catheter|Radiofrequency ablation using platinum-iridium tip catheter
12034811|NCT00325962|Drug|6R-BH4 (sapropterin dihydrochloride)|
12034812|NCT00325949|Drug|Extended release hydrocodone and acetaminophen (Vicodin CR)|2 tablets BID
12034813|NCT00325949|Drug|hydrocodone/acetaminophen extended release (Vicodin CR)|1 tablet BID
12034814|NCT00325949|Drug|placebo|2 tablets BID
12034815|NCT00325936|Drug|Cilnidipine|10~20mg, qd, po for 3 months or 12 months.
12034816|NCT00325923|Behavioral|Decision aid|
12034817|NCT00325910|Drug|Metformin|
12034818|NCT00325897|Drug|Macrolide Antibiotic (Azithromycin)|Azithromycin (daily capsule, 250 mg for 12 months)
12034819|NCT00325897|Drug|Placebo|Placebo taken on a daily basis
12034820|NCT00325871|Procedure|concurrent chemoradiation|
12034821|NCT00325858|Drug|Tramadol HCl ER|
12034822|NCT00325845|Procedure|Synvisc viscosupplementation|
12034823|NCT00325832|Device|BpTRU|
12034824|NCT00325832|Device|Conventional mercury sphygmomanometry|
12034825|NCT00325819|Drug|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
12034826|NCT00325819|Other|placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
12034827|NCT00325806|Drug|Ramipril|
12034828|NCT00325793|Drug|Nicardipine|
12034829|NCT00325780|Drug|Pitavastatin|Pitavastatin 4 mg once daily
12034830|NCT00325767|Drug|nebulized albuterol (2.5 mg/3ml/dose)|
12034831|NCT00325767|Drug|nebulized levalbuterol (1.25 mg/3ml/dose)|
12034835|NCT00325741|Procedure|Hematopoietic Cell Transplantation|1200 cGy total lymphoid irradiation (TLI) are administered on day -11 through -7 and days -4 through -1 pretransplantation; rabbit ATG at 1.5 mg/kg i.v. on days -11 through -7 pretransplantation; one single infusion of donor CD34+ cells plus selected T cell add back on completion of TLI (day 0); mycophenolate mofetil (MMF) is begun on day 0 at a dose of 15 mg/kg bid and stopped on day +28; cyclosporine (CSP) at initial dose of 6.25 mg/kg and adjusted to maintain trough blood levels of 350-500 ng/ml is begun on day -3 to complete withdrawal by 6 months post-transplantation.
12034836|NCT00325728|Drug|Ramelteon|Ramelteon 8mg, tablets, orally, once nightly for up to 8 weeks.
12034837|NCT00325728|Drug|Placebo|Ramelteon placebo matching tablets, orally, once nightly for up to 8 weeks.
12034838|NCT00325715|Drug|AGN 201904|
12034839|NCT00325715|Drug|esomeprazole|
12034840|NCT00325702|Behavioral|community-level intervention for young MSM|The community-level intervention includes small media in the form of role model stories, peer outreach and web-based intervention
12034841|NCT00325689|Drug|Quetiapine or Risperidone + Aripiprazole|Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
12034842|NCT00325689|Drug|Quetiapine or Risperidone + placebo|Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
12034843|NCT00325676|Drug|Pantoprazole|
12034844|NCT00325663|Procedure|Acupuncture|
12034845|NCT00325650|Drug|Rimonabant|Tablet, oral administration
12034846|NCT00325650|Drug|Placebo (for Rimonabant)|Tablet, oral administration
12034847|NCT00325637|Drug|cilnidipine|Cilnidipine 10~20mg, qd, po for 4 weeks.
12034848|NCT00325624|Device|Bluetooth-enabled Glucometer|blood glucose information provided to health care providers
12034849|NCT00325611|Behavioral|Multidisciplinary palliative care team met with patient|
12034850|NCT00325598|Radiation|Partial Breast Irradiation (PBI)|
12034851|NCT00325585|Behavioral|Couples HIV counseling and testing|
12034852|NCT00325585|Behavioral|Women's relationship-focused HIV counseling and testing|
12034853|NCT00325572|Drug|oral zinc and vitamin C supplements|Each child will be provided separate suspensions containing zinc and vitamin C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation
12034854|NCT00325572|Other|oral Placebo|Each child will be provided separate Placebo suspensions C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation
12034855|NCT00325559|Procedure|Normoinsulinemic eu- or hyperglycemic clamp|
12034856|NCT00325546|Drug|Rimonabant (SR141716)|
12034857|NCT00325546|Drug|Placebo|
12034858|NCT00325533|Behavioral|Baseline BP Screening|Barbers in the barbershops in the experimental arm will be trained to accurately measure and interpret blood pressure (BP). Each barber will offer a BP check to customers with each haircut, complete an encounter form after each haircut, discuss the BP reading with the customer, identify customers with elevated BP, and refer customers with elevated BP to a regular physician or other primary provider for long-term BP management. Each time a customer with elevated BP goes to a regular medical provider, he receives a free haircut, and the referring barber receives a monetary bonus.
12034859|NCT00325533|Other|Intensive 10-week Blood Pressure Screening|Intensive 10-week Blood Pressure Screening
12034860|NCT00325507|Biological|TroVax|TroVax 1 x 10E9 TCID 50mL
12034861|NCT00325507|Drug|IL-2|IL-2 250,000 U/kg S/C for cycle 1 and day 1 of subsequent cycles, 125,000U/kg S/C for days 2-5 of cycles 2-6
12034862|NCT00325494|Drug|MORAb-009|Each dose of investigational product will be given as a continuous infusion ranging from 12.5 mg/m^2 up to 400 mg/m^2.
12034863|NCT00325481|Drug|FluMist|
12034864|NCT00325468|Drug|AMG 162|AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
12034865|NCT00325455|Drug|MK0859|
12034866|NCT00325442|Drug|Oral treprostinil (UT-15C) sustained release tablets|UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
12034867|NCT00325442|Drug|Placebo|Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
12034868|NCT00325429|Drug|Vildagliptin|
12034869|NCT00325416|Drug|melphalan|(Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
12034870|NCT00325416|Drug|topotecan (TPT)|"Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
~Phase II: Treatment at maximum tolerated dose (MTD)"
12034871|NCT00325416|Procedure|Autologous Stem Cell Rescue|Day 0
12034872|NCT00325403|Drug|Oral treprostinil (UT-15C) Sustained Release Tablets|Sustained release oral tablet, twice daily
12034873|NCT00325403|Other|Placebo|Placebo oral tablet twice daily
12034874|NCT00325390|Drug|clopidogrel (SR25990C)|
12034875|NCT00325377|Procedure|MME Procedure|
12034876|NCT00325364|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 24 months
12034877|NCT00325364|Drug|Injectable insulin|patient specific dose, injectable, before meals, 24 months
12034878|NCT00325351|Drug|Sagopilone (ZK 219477) + carboplatin|Chemotherapy for recurrent ovarian cancer
12034879|NCT00325338|Biological|Ragweed MATAMPL|
12034880|NCT00325325|Drug|everolimus and tacrolimus|
12034881|NCT00325312|Drug|carbon dioxide, subcutaneous application|
12034882|NCT00325299|Drug|Magnesium|
12034883|NCT00325286|Drug|Lithium Plus Extended- Release Carbamazepine|Preliminary phase subjects receive ERC-CBZ starting dose range from 100 to 200 mg b.i.d. and further titration up to a maximum dose of 1600 mg/day done at the discretion of the investigator. Titration phase will not extend beyond 2 weeks.Open label phase subjects stabilized on lithium and ERC-CBZ therapy will enter this phase for 6 months
12034884|NCT00325273|Dietary Supplement|Lactobacillus rhamnosus GG|use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months
12034885|NCT00325260|Biological|Influvac; subunit influenza vaccine|
12034886|NCT00325247|Drug|ZINC|
12034945|NCT00324831|Procedure|Intervention/procedure|
12034887|NCT00325234|Drug|Pemetrexed|600 mg/m^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.
12034888|NCT00325234|Drug|Carboplatin|AUC 5 mg*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.
12034889|NCT00325234|Drug|Gemcitabine|1200 mg/m^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
12034890|NCT00325234|Drug|Vinorelbine|30 mg/m^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
12034891|NCT00325221|Device|HM on|Home Monitoring activated after implantation
12034892|NCT00325221|Device|HM Off|Home Monitoring activated 9 months after implantation
12034893|NCT00325208|Device|partial-vacuum milk bottle|
12034894|NCT00325208|Device|anti-vacuum milk bottle|
12034895|NCT00325195|Other|placebo|placebo by intravenous infusion every 2 weeks
12034896|NCT00325195|Biological|pegloticase|8 mg pegloticase by intravenous infusion
12034897|NCT00325182|Drug|Levetiracetam|
12034898|NCT00325182|Other|Historical controls|
12034899|NCT00325169|Drug|Tiotropium + SERETIDE 50/500|
12034900|NCT00325156|Biological|GSK Biologicals' combined DTPa-IPV/Hib vaccine|4 intramuscular injections
12034901|NCT00325143|Biological|DTPa-HBV-IPV/Hib|1 intramuscular injection (3rd study vaccine dose)
12034902|NCT00325143|Biological|DTPa-IPV/Hib vaccine|3 intramuscular injections (1st, 2nd and 4th vaccine dose)
12034903|NCT00325130|Biological|Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine|"Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a
~0.5-mL intramuscular dose at Day 1, Month 2, and Month 6."
12034904|NCT00325130|Biological|Comparator: Menactra™ (Concomitant)|A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1
12034905|NCT00325130|Biological|Comparator: Adacel™ (Concomitant)|a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
12034906|NCT00325130|Biological|Comparator: Menactra™ (Non-concomitant)|A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
12034907|NCT00325130|Biological|Comparator: Adacel™|A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
12034908|NCT00325117|Drug|Vildagliptin|
12034909|NCT00325104|Procedure|Parathyroid hormone testing|
12034910|NCT00325104|Procedure|Serum calcium testing|
12034911|NCT00325078|Drug|Infliximab|
12034912|NCT00325039|Procedure|retropubic mid-urethral sling (TVT)|This trial is a comparison of two types of mid-urethral slings. The retropubic mid-urethral mesh sling is used for treatment of stress incontinence; this procedure was less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space.
12034913|NCT00325039|Procedure|transobturator mid-urethral sling (TVT-O and the Monarc)|This trial is a comparison of two types of mid-urethral slings. The transobturator mid-urethral sling is used for treatment of stress incontinence; this procedure was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.
12034914|NCT00325026|Drug|Misoprostol|
12034915|NCT00325026|Device|Foley bulb|
12034916|NCT00325013|Drug|Docosahexaenoic Acid (DHA)|800mg twice a day for 1 year
12034917|NCT00325000|Behavioral|Interpersonal Psychotherapy|
12034918|NCT00325000|Drug|sertraline or amitriptyline|
12034919|NCT00324987|Biological|Bevacizumab|Given IV
12034920|NCT00324987|Drug|Imatinib Mesylate|Given PO
12034921|NCT00324987|Other|Laboratory Biomarker Analysis|Correlative studies
12034922|NCT00324987|Other|Pharmacological Study|Correlative studies
12034923|NCT00324974|Drug|Lansoprazole microgranules suspension|"Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks;
~Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks."
12034924|NCT00324974|Drug|Placebo|Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.
12034925|NCT00324961|Drug|adefovir dipivoxil tablets|adefovir dipivoxil once daily 10 mg orally
12034926|NCT00324948|Drug|Topical alprostadil (PGE-1)|
12034927|NCT00324922|Drug|trimethoprim-sulfamethoxazole|trimethoprim/sulfamethoxazole 320/1600 mg po bid
12034928|NCT00324922|Drug|vancomycin|1g iv bid
12034929|NCT00324909|Drug|Hyperbaric Oxygen Therapy|
12034930|NCT00324896|Drug|eszopiclone|eszopiclone
12034931|NCT00324896|Other|placebo|matching placebo administered at night
12034932|NCT00324870|Drug|vorinostat|Given orally
12034933|NCT00324870|Drug|bevacizumab|Given IV
12034934|NCT00324857|Behavioral|Decision Aid Video|"The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
12034935|NCT00324857|Behavioral|Motivational Interviewing|The research intervention will conduct the fact-to-face MI session with the participant. The MI session will do the following things: 1) Assessing Readiness, Importance, and Confidence; 2) Eliciting Barriers, Concerns and Positive Motivational; 3) Summarizing Pros and Cons; 4) Assess Patient Values and Goals; 5) Provide a Menu of Options.
12034936|NCT00324857|Behavioral|MI plus Decision aid|Patient viewed the video and then underwent MI.
12034937|NCT00324857|Other|Attention control|patients received a booklet.
12034938|NCT00324831|Drug|autologous immunoglobulin idiotype-KLH conjugate vaccine|
12034939|NCT00324831|Drug|cyclophosphamide|
12034940|NCT00324831|Drug|doxorubicin hydrochloride|
12034941|NCT00324831|Drug|prednisone|
12034942|NCT00324831|Drug|rituximab|
12034943|NCT00324831|Drug|sargramostim|
12034944|NCT00324831|Drug|vincristine|
12034950|NCT00324831|Procedure|cytokine therapy|
12034951|NCT00324831|Procedure|monoclonal antibody therapy|
12034952|NCT00324831|Procedure|non-specific immune-modulator therapy|
12034953|NCT00324831|Procedure|therapeutic procedure|
12034954|NCT00324831|Procedure|tumor cell derivative vaccine|
12034955|NCT00324831|Procedure|vaccine therapy|
12034956|NCT00324818|Drug|metronidazole and azithromycin|
12034957|NCT00324805|Biological|Bevacizumab|Given IV
12034958|NCT00324805|Drug|Cisplatin|Given IV
12034959|NCT00324805|Drug|Docetaxel|Given IV
12034960|NCT00324805|Drug|Gemcitabine Hydrochloride|Given IV
12034961|NCT00324805|Other|Laboratory Biomarker Analysis|Correlative studies
12034962|NCT00324805|Drug|Pemetrexed Disodium|Given IV
12034963|NCT00324805|Other|Questionnaire Administration|Ancillary studies
12034964|NCT00324805|Drug|Vinorelbine Tartrate|Given IV
12034965|NCT00324792|Drug|intensive insulin therapy|
12034966|NCT00324779|Biological|rituximab|
12034967|NCT00324766|Drug|levosimendan|1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
12034968|NCT00324766|Drug|placebo,|24 h, infusion
12034969|NCT00324753|Behavioral|Communication|Communication sheet
12034970|NCT00324753|Behavioral|Standard of care|Standard of care brochures
12034971|NCT00324740|Drug|vorinostat|Given orally
12034972|NCT00324740|Drug|isotretinoin|Given orally
12034973|NCT00324727|Drug|melphalan|Given throug isolated hepatic artery infusion
12034974|NCT00324727|Drug|regional chemotherapy|Patients receive the best alternative therapy
12034975|NCT00324727|Drug|systemic chemotherapy|Patients receive the best alternative therapy
12034976|NCT00324727|Procedure|hepatic artery embolization|Patients receive the best alternative therapy
12034977|NCT00324714|Drug|risedronate sodium|
12034978|NCT00324714|Other|diagnostic laboratory biomarker analysis|
12034979|NCT00324701|Behavioral|Telepsychology|therapy done at patients house
12034980|NCT00324701|Behavioral|Face-to-face therapy|therapy delivered at the VAMC
12034981|NCT00324688|Drug|Viread|
12034982|NCT00324675|Drug|Rosiglitazone|4 mg tablets, bid, 12 months
12034983|NCT00324675|Drug|Placebo|2 tablets per day
12034984|NCT00324662|Device|Implantable cardioverter-defibrillator|
12034985|NCT00324649|Drug|Truvada|Truvada once daily with continuation of the current NNRTI or PI at randomization.
12034986|NCT00324649|Drug|Zidovudine/lamivudine|Continuation of the zidovudine + lamivudine containing regimen plus the current NNRTI or PI at randomization.
12034987|NCT00324623|Biological|Melan-A VLP vaccine, IMP321 adjuvant|
12034988|NCT00324623|Biological|adoptive immunotherapy|
12034989|NCT00324623|Biological|therapeutic autologous lymphocytes|
12034990|NCT00324623|Drug|cyclophosphamide|
12034991|NCT00324623|Drug|fludarabine phosphate|
12034992|NCT00324610|Drug|capecitabine|
12034993|NCT00324597|Drug|gemcitabine hydrochloride|
12034994|NCT00324597|Drug|motesanib diphosphate|
12034995|NCT00324597|Other|pharmacological study|
12034996|NCT00324584|Device|Telemonitoring of glucose values using GlucoNet device|
12034997|NCT00324571|Drug|Sevelamer hydrochloride|
12034998|NCT00324571|Drug|Calcium-based phosphate binder|
12034999|NCT00324558|Drug|Bemiparin|subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)
12035000|NCT00324545|Behavioral|Medium-intensity Minimally-directive Counseling|
12035001|NCT00324532|Drug|ProBactrix|
12035002|NCT00324519|Device|Foley bulb|
12035003|NCT00324519|Drug|misoprostol|
12035004|NCT00324506|Drug|Mycophenolate Mofetil (CellCept)|
12035005|NCT00324480|Drug|alvocidib|Given IV
12035006|NCT00324480|Drug|vorinostat|Given orally
12035007|NCT00324480|Other|pharmacological study|Correlative studies
12035008|NCT00324467|Drug|Cyclophosphamide|"Dose: 750 mg/m^2 Administration: IV infusion day 1 over 20-60 minutes Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
12035009|NCT00324467|Drug|Doxorubicin|"Dose: 50 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
12035010|NCT00324467|Drug|Vincristine|"Dose: 1.4 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
12035011|NCT00324467|Drug|Prednisone|"Dose: 45 mg/m^2 Administration: IV infusion day 1 (or day 2) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
12035012|NCT00324467|Drug|Ondansetron|Premedication for R-CHOP Dose: 8 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy
12035013|NCT00324467|Drug|Dexamethasone|Premedication for R-CHOP Dose: 12 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy
12035014|NCT00324467|Drug|Diphenhydramine|Premedication for R-CHOP Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
12035015|NCT00324467|Drug|Acetaminophen|Premedication for R-CHOP Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
12035016|NCT00324467|Drug|Ifosfamide|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3, over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
12035017|NCT00324467|Drug|Mesna (IV)|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3 (with ifosfamide) over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
12035018|NCT00324467|Drug|Mesna (oral)|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 2 g Administration: PO 2h and 4h after ifosfamide infusion on days 1,2,3 Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
12035122|NCT00323596|Behavioral|physical activity program of strength and balance retraining|
12035123|NCT00323583|Drug|paclitaxel|
12035019|NCT00324467|Drug|Carboplatin|"R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5 x (25+CrCl*) (maximum dose 800 mg) Administration: IV infusion day 1 over 1 hour Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
~*Carboplatin is dose via the Calvert formula with an AUC of 5, maximum dose 800 mg per cycle.
~Estimate Creatinine Clearance (CrCl)"
12035020|NCT00324467|Drug|Etoposide|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 100 mg/m^2 Administration: IV infusion day 1,2,3 over 30 minutes Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
12035021|NCT00324467|Drug|Rituximab|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 375 mg/m^2 Administration: IV infusion day 1 (or day 2 or day 3) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
12035022|NCT00324467|Drug|Ondansetron|Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily
12035023|NCT00324467|Drug|Dexamethasone|Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily
12035024|NCT00324467|Drug|Diphenhydramine|Premedication for R-ICE Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
12035025|NCT00324467|Drug|Acetaminophen|Premedication for R-ICE Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
12035026|NCT00324467|Other|PET Scan|Investigations: 18F-FDG-PET scan Timing: After 4 cycles of R-CHOP (days 21-28) and after 4 cycles of R-ICE (days 28-35)
12035027|NCT00324454|Biological|Levetiracetam|Levetiracetam 1500 mg BID
12035028|NCT00324441|Device|Iratherm® 1000|
12035029|NCT00324428|Procedure|Transcranial Magnetic Stimulation|1Hz repetitive transcranial magnetic stimulation for 10 days 26 minutes each day
12035030|NCT00324415|Biological|cetuximab|400 mg/m2 IV Day -7 (1 week before the cycle 1, Day 1 cisplatin/5-FU and RT), then 250 mg/m2 IV Days 1, 8, 15, 22, 29, 36 and 43 (a minimum of 6 and a maximum of 8 doses of cetuximab will be administered, including the loading dose)
12035031|NCT00324415|Drug|cisplatin|75 mg/m2 IV on Day 1 (cycle 1) and Day 29 (cycle 2)
12035032|NCT00324415|Drug|fluorouracil|1000 mg/m2/day by continuous intravenous infusion on Days 1-4 (cycle 1) and Days 29-32 (cycle 2)
12035033|NCT00324415|Radiation|radiation therapy|Irradiation to tumor site and inguinal nodes beginning on cycle 1, Day 1 cisplatin/5-FU (minimum 45.0 Gy [5 weeks if given on schedule and without interruption], maximum 54.0 Gy [6 weeks if given on schedule and without interruption). IMRT may be used at the discretion of the treating physician.
12035034|NCT00324389|Drug|Interferon alpha|
12035035|NCT00324376|Drug|Sevelamer hydrochloride|
12035036|NCT00324363|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
12035037|NCT00324363|Drug|Placebo|subcutaneous injection twice daily in volumes equal to exenatide
12035038|NCT00324350|Drug|hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents|type 2 diabetes treatments, per standard of care
12035039|NCT00324324|Drug|moxifloxacin hydrochloride|Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
12035040|NCT00324324|Drug|Placebo|Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
12035041|NCT00324311|Drug|DGD|Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
12035042|NCT00324298|Biological|bleomycin sulfate|
12035043|NCT00324298|Drug|cisplatin|
12035044|NCT00324298|Drug|etoposide|
12035045|NCT00324298|Procedure|management of therapy complications|
12035046|NCT00324285|Drug|Amylase resistant starch added ORS|
12035047|NCT00324272|Drug|Fibrin Sealant (Tisseel) used in the Experimental Arm.|"For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK.
~For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects)."
12035048|NCT00324259|Drug|Estradiol|
12035049|NCT00324233|Device|Intermittent catheter|SpeediCath catherter (SC) for intermittent catherisation
12035050|NCT00324233|Device|Compact intermittent catheter|SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males
12035051|NCT00324220|Drug|MGCD0103|MGCD0103 Oral administration 3 times per week.
12035052|NCT00324194|Drug|MGCD0103|MGCD0103 oral dose given 2 times per week.
12035053|NCT00324168|Drug|Antibiotics|moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization
12035054|NCT00324168|Drug|Topical corticosteroid|prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week
12035055|NCT00324168|Drug|Placebo|0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week
12035056|NCT00324155|Drug|Ipilimumab|"Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent
~In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression"
12035057|NCT00324155|Drug|Placebo|Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent
12035058|NCT00324155|Drug|Dacarbazine|Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent
12035059|NCT00324142|Drug|Oral tinidazole|
12035060|NCT00324129|Drug|MGCD0103|MGCD0103 given orally three times per week.
12035061|NCT00324116|Drug|pegaptanib sodium (Macugen)|0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
12035062|NCT00324103|Drug|Structured Treatment Interruptions|
12035063|NCT00324090|Behavioral|High and low glycemic index|
12035064|NCT00324077|Drug|Dasatinib in combination with imatinib|
12035065|NCT00324064|Procedure|GHRH/arginine stimulation testing|GHRH(Geref) 1mcg/kg IVP followed by Arginine 10% solution 0.5mg/kg (maximum of 30 Gm) infused over 30 minutes. Labs drawn 6 times over 2 hours.
12035066|NCT00324051|Drug|olanzapine therapy|
12035067|NCT00324038|Drug|Buprenorphine|buprenorphine transdermal system 5, 10 and 20 mg
12035068|NCT00324038|Drug|Codeine paracetamol|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
12035069|NCT00324025|Drug|Mycograb|
12035070|NCT00324025|Drug|placebo|
12035071|NCT00324012|Drug|cisplatin, taxotere|cisplatin 75 mg/m2 Taxotere 75 mg/m2
12035072|NCT00323999|Procedure|Hysteroscopic resection of fibroids, polyps and endometrium.|
12035073|NCT00323986|Drug|azithromycin (drug)|
12035074|NCT00323973|Drug|Bisoprolol|10 mg qd
12035075|NCT00323960|Drug|3 MPDN pulse + PDN|3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
12035076|NCT00323960|Drug|3 MPDN pulse + PDN + CSA|3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
12035077|NCT00323960|Drug|3 MPDN pulse + PDN + MTX|3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
12035078|NCT00323947|Drug|Extended Release Methylphenidate (OROS-Methylphenidate)|"Participants will first take either immediate release MPH or placebo A for 1 day. On Day 2 of treatment, participants assigned to receive XR-MPH will begin taking it, and participants assigned to receive placebo will switch to placebo B. This treatment phase will continue for 6 days to 4 weeks, depending on weight, and will then be followed by a 1-week medication washout period. Target dose depends on the weight of the participant. Possible dose forms include 18, 36, 54 mg OROS-MPH."
12035079|NCT00323934|Drug|MGCD0103|Oral dosage 2 times weekly.
12035080|NCT00323921|Device|dermatological infrared laser|
12035081|NCT00323895|Device|drug-eluting stent and balloon angioplasty|CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
12035082|NCT00323895|Device|drug-eluting stent and balloon angioplasty|CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
12035083|NCT00323895|Device|drug-eluting stent|CYPHER Select ™ Sirolimus-eluting Stent
12035084|NCT00323882|Drug|MDX-010|selected dose administered IV every 3 weeks
12035085|NCT00323869|Drug|Bevacizumab|Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
12035086|NCT00323869|Drug|Gemcitabine|Nucleoside analog
12035087|NCT00323869|Drug|Carboplatin|Alkylating agent
12035088|NCT00323856|Drug|Alphanate SD/HT|Plasma-derived preparation of Factor VIII
12035089|NCT00323843|Drug|Isoproterenol|
12035090|NCT00323830|Drug|Capecitabine, cisplatin, Radiotherapy (+/-)|Capecitabine, cisplatin + Radiotherapy (randomized)
12035091|NCT00323817|Drug|Z-338|
12035092|NCT00323804|Biological|Peginterferon alfa-2b|PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36
12035093|NCT00323804|Drug|Ribavirin|Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36
12035094|NCT00323804|Drug|Ribavirin-Placebo|Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36
12035095|NCT00323791|Drug|gemcitabine hydrochloride|
12035096|NCT00323791|Drug|imatinib mesylate|
12035097|NCT00323791|Genetic|gene expression analysis|
12035098|NCT00323791|Genetic|protein expression analysis|
12035099|NCT00323791|Other|immunohistochemistry staining method|
12035100|NCT00323791|Other|laboratory biomarker analysis|
12035101|NCT00323778|Drug|Hyalgan|
12035102|NCT00323752|Procedure|rHuEpo|Subjects will be randomly assigned to either participate in the PAD program or receive the rHuEpo treatment. Subjects in the PAD group will donate 1 unit of blood at -14 and -7 days prior to surgery. A dose of 500 IU of rHuEpo will be administered subcutaneously to subjects in the rHuEpo group at -21, -14, and -7 days prior to surgery.
12035103|NCT00323739|Drug|bevacizumab|Bevacizumab 10mg/kg, IV infusion, every 2 weeks
12035104|NCT00323739|Drug|RAD001|RAD001 10 mg by mouth daily
12035105|NCT00323713|Behavioral|Very low protein diet|0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids
12035106|NCT00323713|Behavioral|Low protein diet|0.6 g of protein per kilo of body weight per day
12035107|NCT00323687|Drug|Truvada|300mg / 200 mg QD tenofovir DF and Emtricitabine Fixed Dose Combination (FDC) Tablet (oral)
12035108|NCT00323674|Device|Polysoft Mesh|Polysoft Mesh is used.
12035109|NCT00323674|Device|Light Weight Mesh|Light Weight Mesh is used.
12035110|NCT00323661|Device|Rate-adaptive pacemaker: accelerometer|Accelerometer based pacing rate adaptation
12035111|NCT00323661|Device|Rate-adaptive pacemaker: Closed Loop Stimulation|Closed Loop Stimulation (CLS) is a unique concept in rate-adaptive pacing that uses the natural cardiovascular control loop to determine the appropriate pacing rate. Closed Loop Stimulation is the only rate-adaptive system responding to mental stress and thereby assuring optimal cerebral perfusion in everyday activity.
12035112|NCT00323648|Drug|Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis|Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis.
12035113|NCT00323635|Drug|tolterodine|tablet, 4 mg, daily, 1 month
12035114|NCT00323622|Biological|GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049|IM injection in the deltoid muscle
12035115|NCT00323622|Biological|Engerix™-B|IM injection in the deltoid muscle
12035116|NCT00323622|Biological|Hiberix®|IM injection in the deltoid muscle
12035117|NCT00323622|Biological|Prevnar™|IM injection in the deltoid muscle
12035118|NCT00323622|Drug|sulfadoxine-pyrimethamine|1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance
12035119|NCT00323622|Drug|amodiaquine|1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance
12035120|NCT00323609|Procedure|Vertebroplasty|Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.
12035121|NCT00323609|Procedure|Kyphoplasty|Balloon Kyphoplasty involves two inflatable bone tamps placed into the vertebral body in the spine. After the tamps are removed, the void is filled with viscous bone cement.
12035124|NCT00323583|Drug|oxaliplatin|
12035128|NCT00323583|Drug|calcium and magnesium|
12035129|NCT00323583|Procedure|Chemotherapy|
12035130|NCT00323583|Procedure|Chemoprotection|
12035131|NCT00323583|Procedure|Complementary and alternative therapy|
12035132|NCT00323570|Drug|activated recombinant human factor VII|
12035133|NCT00323557|Drug|Sargramostim (GM-CSF)|Starting with 3 doses of 250 micrograms subcutaneously, either pre or post vaccine. For pre vaccine, GM-CSF on days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0); and for post-vaccine GM-CSF given simultaneously on day of vaccination (day 0) and 2 more doses Day +3 and Day +7 after pneumococcal vaccine.
12035134|NCT00323557|Biological|Pneumococcal Vaccine|Subcutaneously on Day 0
12035135|NCT00323544|Drug|zidovudine and lamivudine (Combivir®)|
12035136|NCT00323544|Drug|emtricitabine and tenofovir DF|
12035137|NCT00323531|Procedure|Chest tube with tPA infusion for 3 days|fibrinolysis through the chest tube
12035138|NCT00323531|Procedure|VATS decortication|thoracoscopic decortication
12035139|NCT00323518|Drug|velafermin|administered intravenously as 100mL single dose over 15 minutes on day 1
12035140|NCT00323518|Drug|placebo|administered intravenously as 100mL single dose over 15 minutes on day 1
12035141|NCT00323505|Drug|Pegylated Interferon|
12035142|NCT00323505|Drug|Interferon-alpha2a|
12035143|NCT00323492|Drug|Truvada|Truvada + NNRTI or PI.
12035144|NCT00323492|Drug|Current HAART regimen|Maintain baseline regimen
12035145|NCT00323479|Drug|Anastrozole|1mg/Day oral
12035146|NCT00323466|Procedure|IMRT versus conventional radiotherapy|Comparing MRT versus conventional radiotherapy
12035147|NCT00323453|Device|Open appendectomy using Alexis Wound Retractor followed by standardized wound closure|The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
12035148|NCT00323453|Procedure|Open appendectomy with standardized wound closure|The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
12035149|NCT00323427|Behavioral|The Living Well with Hearing Loss Workshop|Interactive group session modeled on Patient-Centered medicine and Adult Learning principles; the participants are partners with the Group Facilitator who is a hearing rehabilitation professional
12035150|NCT00323427|Device|hearing aid services|Standard VA audiological hearing aid dispensing services
12035151|NCT00323414|Drug|Polyunsaturated fatty acid (Opti-EPA)|Active experimental arm to patients with diabetes mellitus and non alcoholic steatohepatitis: Eicosapentaenoic acid (EPA):Docosahexaenoic acid (DHA)[360 mg EPA and 240 DHA in each capsule] 6 capsules-3 capsules by mouth 2 x per day x 48 weeks
12035152|NCT00323414|Drug|Placebo|Placebo gelcaps containing corn oil identical to the PUFA gelcaps 6 capsules-3 capsules by mouth 2x per day x 48 weeks
12035153|NCT00323401|Other|Antenatal classes|3 sessions of 3 hours each
12035154|NCT00323401|Other|Antenatal classes|antenatal programme
12035155|NCT00323401|Other|Educational programme|3 times, 3 hours intervention programme
12035156|NCT00323401|Other|Educational programme|no programme are offered
12035157|NCT00323375|Drug|AQ-13|A treatment dose of AQ-13 (1750 mg base) was administered orally to subjects randomized to AQ-13 over 3 days (as two capsules on days 1 and 2, plus one capsule on day 3).
12035158|NCT00323375|Drug|Chloroquine (CQ) Treatment|A treatment dose of CQ (1500 mg CQ base) was administered orally to subjects randomized to CQ over 3 days (as two capsules on days 1 and 2, and one capsule on day 3).
12035159|NCT00323362|Drug|gemcitabine hydrochloride|1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
12035160|NCT00323362|Drug|imatinib mesylate|400 mg/day orally, given Days 1-5 and 8-12 every 21 days
12035161|NCT00323349|Procedure|Oral Glucose Tolerance Testing|
12035162|NCT00323349|Behavioral|Education tailored to learning style preferences|
12035163|NCT00323323|Drug|CHOP|CHOP will be given 60-120 minutes following SQ administration of Alemtuzumab as follows: cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, vincristine 1.4 mg/m2 (maximum dose = 2 mg) IV on day 1, and prednisone 100 mg PO on days 1-5.
12035164|NCT00323323|Drug|Alemtuzumab|Single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5.
12035165|NCT00323323|Procedure|Plasma Samples|Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose.
12035166|NCT00323310|Drug|gadobenate dimeglumine|A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.
12035167|NCT00323297|Drug|Bosentan|Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
12035168|NCT00323297|Other|Placebo|Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
12035169|NCT00323297|Drug|Bosentan|Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
12035170|NCT00323297|Drug|Sildenafil Citrate|Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
12035171|NCT00323284|Device|iStent plus Cataract Surgery|ab interno trabecular bypass stent surgery
12035172|NCT00323284|Procedure|Cataract surgery only|Cataract surgery only
12035173|NCT00323271|Behavioral|Cognitive-behavior therapy|CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11).
12035307|NCT00322101|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
12035346|NCT00321893|Other|Placebo|Inhaled placebo twice daily for one year.
12035174|NCT00323271|Other|Interventional|Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system.
12035175|NCT00323258|Behavioral|oral education & written tips for remembering medications|Clinical pharmacist will review purpose of medications of interest (beta-blockers, statins, Angiotensin Converting Enzyme Inhibitor (ACEI)/Angiotensin Receptor Blocker (ARB), aspirin, and other anti-platelets) with the subject. A written list of tips for remembering medications will be provided and reviewed.
12035176|NCT00323258|Device|pill box|Subject is provided a pill box and briefly instructed on how to use the box.
12035177|NCT00323258|Device|pocket medication card|Subject is provided with a card that contains space for prescription and non-prescription medications. If desired the clinical pharmacist-investigator will complete the card for the subject.
12035178|NCT00323258|Behavioral|sharing information with community pharmacist|A fax is sent to the designated community pharmacy at the time of the subject's discharge from the hospital. The fax contains the subject's medications of interest, barriers to medication adherence, and physicians' contact information.
12035179|NCT00323258|Behavioral|Medication use evaluations by community pharmacist|The community pharmacist will assess use of medications of interest at time of first medication fill and by reviewing the subject's computerized medication profile at the pharmacy. Assessments occur at first visit to pharmacy, 6-weeks, 12-weeks, 18-weeks, and 24-weeks. If there are issues with any medications of interest the subject will be called. If needed, the subject's health care team will be notified.
12035180|NCT00323258|Behavioral|informing physician if patient has stopped a medication|The community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped.
12035181|NCT00323258|Behavioral|Routine discharge counseling|Both groups received routine discharge counseling performed by the patient-care nurse.
12035182|NCT00323258|Other|Letter to physician/discharge summary|A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations.
12035183|NCT00323245|Behavioral|Physiotherapy for urinary incontinence|See Detailed Description.
12035184|NCT00323232|Device|2 Versus 4 Hole DHS|See Detailed Description.
12035185|NCT00323219|Drug|Cefazolin and Moxifloxacin|See Detailed Description.
12035186|NCT00323206|Biological|IL-12p DNA|Plasmid IL-12 will be administered as an intratympanic (IT) injection.
12035187|NCT00323206|Procedure|Intratumoral Electroporation|The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated.
12035188|NCT00323193|Behavioral|MOVE!|group based psychoeducation, motivation and support
12035189|NCT00323154|Drug|Nalbuphine|
12035190|NCT00323141|Device|Ventralex versus Leight Weight Vypro II prothesis|Ventralex and Leight Weight Vypro II prothesis are compared.
12035191|NCT00323128|Procedure|Calculation of inuline clearance|Calculation of inuline clearance.
12035192|NCT00323128|Procedure|Measuring serum creatinine|Measuring serum creatinine.
12035193|NCT00323115|Biological|Autologous Dendritic Cell|Vaccine given by cervical lymph node injection 3 times every other week
12035194|NCT00323115|Drug|Temozolomide|Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC
12035195|NCT00323115|Procedure|Radiotherapy|RT is standard of care (SOC) post surgery
12035196|NCT00323115|Biological|Dendritic Cell Vaccine|Vaccine given cervical lymphnode injection 3 times every other week
12035197|NCT00323102|Drug|Multihance|
12035198|NCT00323089|Procedure|microcoil insertion and excision|The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
12035199|NCT00323076|Drug|18F-FAZA PET Imaging|"Phase I: 110-600 MBq per injection. A single injection of 18F-FAZA and PET scan will be permitted per patient.
~Phase II: 110-600 MBq per injection. Up to three separate injections of 18F-FAZA and PET scans will be permitted per patient."
12035200|NCT00323063|Drug|gemcitabine hydrochloride|Given IV
12035201|NCT00323063|Drug|imatinib mesylate|Given orally
12035202|NCT00323050|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|
12035203|NCT00323037|Drug|carvedilol controlled release|Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily.
12035204|NCT00323037|Drug|carvedilol immediate release|Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
12035205|NCT00323024|Drug|NX1011|
12035206|NCT00323011|Drug|Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab|
12035207|NCT00322985|Drug|Lenalidomide|25 mg/day, orally for 21 days with 7 days rest (28 day cycle). Dosing will be in the morning at approximately the same time each day.
12035208|NCT00322972|Drug|Mass treatment with oral azithromycin to an entire community|For baseline and follow-up surveys prior to azithromycin distribution, a stratified random sample from two age groups will be chosen: 1) 60 study participants younger than 10 years old and 2) 60 study participants aged 10 years and above. Clinical examination will be performed and conjunctival swabs will be taken from all the study participants. For study arm C and D, nasopharyngeal swabs will be collected from 10 randomly selected children among the 60 participants under 10 who were recruited for conjunctival swabbing. Then a single dose of azithromycin will be distributed according to study design: in tablet form for adults; a weight-adjusted tablet dose for children ages 8-10; and pediatric suspension for children ages 1 - 7.
12035209|NCT00322946|Biological|rDEN4delta30-4995|Live attenuated rDEN4delta30-4995 vaccine (one of three doses)
12035210|NCT00322946|Biological|Placebo|Placebo for rDEN4delta30-4995
12035211|NCT00322933|Procedure|renal replacement therapy (intermittent or continuous)|
12035212|NCT00322920|Drug|Topotecan|
12035213|NCT00322920|Drug|Cisplatin|
12035214|NCT00322907|Drug|Cotrifazid vs mefloquine or quinine+SP|
12035215|NCT00322881|Drug|Paclitaxel|
12035216|NCT00322881|Drug|Carboplatin|
12035217|NCT00322868|Drug|pioglitazone|All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.
12035218|NCT00322842|Drug|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
12035219|NCT00322803|Drug|ELB139|
12035220|NCT00322777|Behavioral|Spirituality Teaching Program|The Spirituality Teaching Program is a home study program delivered through audio CDs over an 8-week period. The program consists of weekly 90 minute teaching sessions, based on the content of a workshop developed to assist users in developing a more spiritual outlook on life and coping resources. Using didactic comment and storytelling, the following spiritual concepts are addressed in the sessions: self-transcendence, connectedness, forgiveness, self-acceptance, detachment, compassion and gratitude. Each session concludes with a relevant guided visualization practice. In addition, a 15-minute progressive relaxation exercise is included that is to be used on a daily basis. The presented content is nondenominational to ensure compatibility with any beliefs participants may hold.
12035221|NCT00322764|Drug|Uridine|
12035222|NCT00322751|Drug|Topotecan|The starting dose for the first cohort will be 2 mg/m2/week. Increment between cohorts will be by 1 mg/m2/week if no toxicity related to topotecan occurs. All members of a dose cohort must have safely completed all radiotherapy and topotecan dosing prior to beginning enrollment in the next higher dose cohort. Increments will be reduced to 0.5 mg/m2 if mild to moderate toxicity occurs (grades 1 or 2). The escalation will continue until the maximum dose of 4 mg/m2/week is reached. Therefore the minimum number of dose levels (cohorts) is 3 to reach the goal of 4 mg/m2/week, and the maximum is 5.
12035223|NCT00322699|Procedure|Whole bladder laser light treatment as an alternative to radical cystectomy|The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.
12035224|NCT00322699|Drug|Photofrin|The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.
12035225|NCT00322686|Drug|Oglemilast|Oglemilast, 15mg oral administration, once per day and then dose-matched placebo
12035226|NCT00322686|Drug|Placebo then Oglemilast|Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.
12035227|NCT00322673|Drug|XL999|XL999 was administered at a dose of 2.4 mg/kg given as a 4-hour IV infusion weekly for 4 weeks. In the absence of progressive disease and unacceptable toxicity, subjects were to receive XL999 treatment weekly for up to 1 year on this study
12035228|NCT00322660|Drug|Adrenaline|
12035229|NCT00322621|Drug|Duloxetine|
12035230|NCT00322608|Drug|NPI-2358|Treatment on Days 1, 8 and 15 in a 28 day cycle
12035231|NCT00322595|Drug|Quetiapine fumarate|
12035232|NCT00322595|Drug|Paroxetine|
12035233|NCT00322569|Device|Corio™ Pimecrolimus-Eluting Coronary Stent System|Drug-eluting stent
12035234|NCT00322569|Device|SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System|Drug-eluting stent
12035235|NCT00322569|Device|Costar ™ Paclitaxel-Eluting Coronary Stent System|Drug-eluting Stent
12035236|NCT00322556|Drug|Immunoglobulins Intravenous (Human)|Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw
12035237|NCT00322543|Device|Corio™ Pimecrolimus-eluting stent|
12035238|NCT00322530|Procedure|Renal replacement therapy|ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED
12035239|NCT00322517|Drug|SU014813|100 mg capsule/day for 6 cycle of 21 days
12035240|NCT00322504|Procedure|Accupuncture|
12035241|NCT00322491|Drug|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
12035242|NCT00322478|Behavioral|Automated informatics driven education and social networking|The patient uses a self-contained wireless accessory to a standard blood glucose meter. This device manages the meter to ensure accurate time stamps and transmits the data to a centralized data management system. The system is then configured to assess the data and take automated steps to derive relevant diabetes education and/or send reports to a registered and authorized team.
12035243|NCT00322478|Behavioral|Blood Glucose Notifications to Remote Caregivers|When children with type 1 diabetes are at school they will connect their blood glucose meter to the GlucoMON appliance. The data from the meter is then transmitted to the central system followed by the most recent blood sugar being sent to the primary caregiver's email address(es) as a plain text message. The investigator is interested to better understand the behaviors that accompany the expectation of the message and actions taken subsequent to receipt of the message by the patient-centric team.
12035244|NCT00322478|Behavioral|Frequency of Pattern Management|The behavioral intervention being studied involves the assessment of frequency of self-care in relation to the primary and secondary outcomes including overall blood sugar control and patient satisfaction.
12035245|NCT00322465|Drug|Tinidazole|2 gm single dose (4 tablets orally at 500 mg each).
12035246|NCT00322465|Other|Placebo|Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.
12035247|NCT00322465|Drug|Doxycycline|100 mg orally, twice daily for 7 days.
12035248|NCT00322465|Drug|Azithromycin|1 gram (gm) (2 tablets orally at 500 milligrams (mg) each).
12035249|NCT00322452|Drug|Gefitinib|oral tablet
12035250|NCT00322452|Drug|Carboplatin|IV
12035251|NCT00322452|Drug|Paclitaxel|IV
12035252|NCT00322439|Drug|Etanercept|Observational study - no drug administered
12035253|NCT00322426|Device|Sensory Cueing Device|
12035254|NCT00322413|Drug|Epoetin|
12035255|NCT00322400|Drug|Docetaxel|Subjects assigned to Arm B, cohorts will receive 75 or 100 mg/m2 of docetaxel (based on cohort assignment) on Day 1 repeated every 21 days (1 cycle). AMG 706 will be administered concurrently on Days 3-21 of Cycle 1, and Days 1-21 of Cycle 2 and beyond.
12035256|NCT00322400|Drug|Paclitaxel|Subjects assigned to Arm A will receive 90 mg/m2 of paclitaxel on Days 1, 8 and 15 repeated every 28 days (1 cycle). On Arm A, AMG 706 will be concurrently administered on Days 3-28 of Cycle 1, and Days 1-28 of Cycle 2 and beyond.
12035257|NCT00322400|Drug|AMG 706|"Subjects assigned to Arm A will receive AMG 706 at 50, 75, 100 or 125 mg daily (based on cohort assignment) on Days 3-28 of Cycle 1, and Days 1-28 of Cycle 2 and beyond in combination wth paclitaxel 90 mg/m2. Paclitaxel will be administered on Days 1, 8 and 15 every 28 days.
~Subjects assigned to Arm B will receive AMG 706 at 50, 75, 100 or 125 mg daily(based on cohort assignment) on Days 3-21 of Cycle 1, and Days 1-21 of Cycle 2 and beyond in combination with docetaxel. Docetaxel will be administered at either 75 mg/m2 or 100 mg/m2 on Day 1 every 21 days."
12035258|NCT00322387|Drug|G-CSF and plerixafor|G-CSF and plerixafor were administered as described in the treatment arms.
12035259|NCT00322374|Drug|Ixabepilone|Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.
12035260|NCT00322374|Drug|Epirubicin|Infusion, intravenous (IV): 75 mg/m^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².
12035261|NCT00322361|Biological|Comparator: RECOMBIVAX HB™|RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
12035262|NCT00322361|Biological|Comparator: Modified process Hepatitis B Vaccine|Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
12035263|NCT00322348|Drug|Goserelin acetate|3.6 mg intramuscular depot injection given every 4 weeks
12035264|NCT00322348|Drug|Goserelin acetate|10.8 mg intramuscular depot injection given every 12 weeks
12035265|NCT00322335|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
12035266|NCT00322335|Biological|Infanrix™ penta|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
12035267|NCT00322335|Biological|Infanrix™ hexa|Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
12035268|NCT00322335|Biological|Engerix-B|Intramuscular injection into the thigh as a birth dose
12035269|NCT00322335|Biological|NeisVac-C™|Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
12035270|NCT00322335|Biological|Infanrix™ IPV/HIB|Intramuscular injection into the thigh as primary vaccination at 4 months of age
12035271|NCT00322335|Biological|Meningitec™|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
12035272|NCT00322322|Drug|L-Carnitine|L-Carnitine
12035273|NCT00322309|Other|Placebo|Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84
12035274|NCT00322309|Drug|Mirtazapine|Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
12035275|NCT00322296|Drug|Bexarotene 1% gel|
12035276|NCT00322283|Drug|Oglemilast|Oglemilast, 15mg once per day, oral administration
12035277|NCT00322283|Drug|Placebo|Dose-marched placebo, once per day, oral administration
12035278|NCT00322270|Drug|Alfimeprase|single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
12035279|NCT00322257|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
12035280|NCT00322257|Drug|insulin detemir|Injection s.c., 50% of daily dose
12035281|NCT00322257|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c.
12035282|NCT00322244|Procedure|Massage Therapy|
12035283|NCT00322231|Biological|zoster vaccine live (ZOSTAVAX™)|1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
12035284|NCT00322231|Biological|Comparator: Placebo|1 dose 0.65 mL/dose subcutaneous injection of placebo.
12035285|NCT00322218|Drug|Zevalin Therapeutic Regimen|Zevalin Therapeutic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
12035286|NCT00322218|Other|Observation|Observation
12035287|NCT00322205|Drug|zyban|
12035288|NCT00322192|Behavioral|Conventional UK Physical therapy|
12035289|NCT00322192|Behavioral|Increased intensity of UK conventional physical therapy|
12035290|NCT00322192|Behavioral|UK conventional physical therapy plus functional strength training|
12035291|NCT00322166|Other|Sunlight|Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week.
12035292|NCT00322166|Other|Sunlight and calcium|Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week. In the calcium and sunlight arm, calcium supplements (Caltrate, 600mg elemental calcium, Whitehall) will be administered to the whole group via the Blister/ Webster packs.
12035293|NCT00322166|Other|control|Subjects in the control group will be provided with a brochure about vitamin D deficiency and how to treat it. They will receive their usual routine care and nutrition.
12035294|NCT00322153|Drug|memantine ER|28mg(7mg capsules) once daily and oral administration for 24 weeks.
12035295|NCT00322153|Drug|Placebo|Matching placebo oral administration once daily.
12035296|NCT00322140|Drug|CDDO|
12035297|NCT00322127|Drug|AMD3100|a 2 mL clear glass vial containing 1.7 mL of a sterile isotonic solution.
12035298|NCT00322114|Dietary Supplement|lycopene|Given orally
12035299|NCT00322114|Other|placebo|Given orally
12035300|NCT00322101|Radiation|total-body irradiation|Radiation
12035301|NCT00322101|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic transplantation
12035302|NCT00322101|Drug|cyclophosphamide|Given IV
12035303|NCT00322101|Drug|mycophenolate mofetil|Given orally
12035304|NCT00322101|Drug|busulfan|Given IV or orally
12035305|NCT00322101|Drug|cyclosporine|Given IV or orally
12035306|NCT00322101|Drug|fludarabine phosphate|Given IV
12035308|NCT00322101|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic transplantation
12035309|NCT00322101|Other|laboratory biomarker analysis|Correlative studies
12035310|NCT00322101|Genetic|cytogenetic analysis|Correlative studies
12035311|NCT00322101|Other|flow cytometry|Correlative studies
12035312|NCT00322101|Genetic|fluorescence in situ hybridization|Correlative studies
12035313|NCT00322101|Other|pharmacological study|Correlative studies
12035314|NCT00322101|Genetic|polymorphism analysis|Correlative studies
12035315|NCT00322101|Drug|tacrolimus|Given IV or orally
12035316|NCT00322101|Drug|methotrexate|Given IV
12035317|NCT00322075|Drug|insulin glargine|
12035318|NCT00322062|Drug|macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate|2L gut lavage solution
12035319|NCT00322062|Drug|Sodium Phosphate Solution|1 x 45ml solution, BID
12035320|NCT00322049|Biological|Tetravalent live attenuated dengue vaccine|"DEN candidate vaccine: One dose of the tetravalent, live attenuated DEN vaccine candidate, F17, contains dengue serotype 1, 2, 3 and 4 vaccines. This formulation contains 50 mcg/mL neomycin base, 5.5% lactose, and 1.9 g/dL human serum albumin; for subcutaneous injection.
~Infants received dengue vaccine at study months 0 and 6 or control vaccine (varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6). Both control vaccines are licensed for use in Thailand.
~All infants subsequently received an inactivated JE vaccine approximately one and 1.5 months following dengue vaccine dose 2. The licensed JE vaccine in liquid form, was dosed at 0.25 ml for subcutaneous injection.
~A booster dose of DEN vaccine was given to all subjects previously vaccinated with DEN vaccine in Dengue -001. The booster dose was administered approximately 42 months after dose 2 (at the Year 3 visit)."
12035321|NCT00322049|Biological|Varicella vaccine and Haemophilus influenzae Type b Conjugate vaccine|Infants received dengue vaccine at study months 0 and 6 or control vaccine (varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6). Both control vaccines are licensed for use in Thailand.
12035322|NCT00322036|Drug|MPC-7869|Oral 800 mg BID
12035323|NCT00322036|Drug|MPC-7869|Oral BID dosing
12035324|NCT00322023|Drug|D-serine|D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks.
12035325|NCT00322023|Drug|D-serine|
12035326|NCT00322023|Drug|D-serine|
12035327|NCT00322023|Drug|D-serine|
12035328|NCT00322010|Procedure|early PT OT|"Passive range of motion exercises for all limbs in patients who remain unresponsive despite sedative interruption (ten repetitions in all cardinal directions).
~Sessions began with active assisted and active range of motion exercises in the supine position.
~If tolerated, treatment is advanced to bed mobility activities, including transferring to upright sitting.
~Sitting balance activities are followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
~The session progresses to transfer training, and finally pre-gait exercises and ambulation.
~Progression of activities is dependent on patient tolerance and stability.
~Therapy intervention continues on a daily basis throughout the patient's hospital stay until he/she returns to prior level of function or is discharged."
12035329|NCT00321997|Drug|Pegaptanib sodium|
12035330|NCT00321984|Drug|Dexlansoprazole MR|Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
12035331|NCT00321984|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
12035332|NCT00321984|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
12035333|NCT00321971|Behavioral|PST-MCI/AD Caregiving|The PST-based intervention will train participants to effectively use problem-solving skills with the aim of strengthening their ability to cope and preventing the onset or worsening of depressive and anxiety disorders. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.
12035334|NCT00321971|Behavioral|NT-MCI/AD Caregiving|The nutritional education program will be based on the new USSDA dietary recommendations. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.
12035335|NCT00321958|Device|CSA System (CryoSpray AblationTM System)|10 second spray times
12035336|NCT00321958|Device|CryoSpray Ablation|10 second spray times
12035337|NCT00321945|Procedure|ACE-Inhibitors and Angiotensin Receptor Blockers|Retrospective study - no intervention as part of study.
12035338|NCT00321932|Dietary Supplement|calcium|All randomized patients (control and study drug) will take 1000 mg of calcium and 400 - 500 International Units (IU) of vitamin D orally each day, beginning as soon as possible after study enrollment. These supplements may be taken either in the morning or in the evening with food. Participants will continue taking the supplements on a daily basis until the final study visit (approximately 12 months after the transplant date).
12035339|NCT00321932|Dietary Supplement|cholecalciferol|Given orally
12035340|NCT00321932|Drug|zoledronic acid|Zoledronic acid (Zometa®) will be administered after randomization (but within 28 days prior to transplant) and at 3 and 6 months after the transplant for a total of 3 doses. The dose of Zometa will be 4 mg intravenous in 100 ml of sterile 0.9% sodium chloride, United States Pharmacopeia (USP), or 5% dextrose, USP infused over a minimum of 15 minutes for patients with a calculated creatinine clearance of ≥60 mL/min. The drug may be administered through a peripheral or a central intravenous line.
12035341|NCT00321919|Drug|epoetin beta [NeoRecormon]|Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.
12035342|NCT00321919|Drug|epoetin beta [NeoRecormon]|Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to <10.5 g/dL had occurred.
12035343|NCT00321906|Drug|azathioprine|azathioprine 2mg/kg
12035344|NCT00321906|Drug|sirolimus|sirolimus 2-4mg daily
12035345|NCT00321893|Drug|Budesonide|Inhaled Budesonide 800 micrograms (ug) twice daily for one year.
12035347|NCT00321880|Procedure|therapeutic touch|administration of healing touch in 30 minute sessions
12035348|NCT00321867|Procedure|Graft augmented posterior repair|Posterior repair with graft
12035349|NCT00321867|Procedure|Control|Native tissue repair
12035350|NCT00321854|Drug|pramipexole|
12035351|NCT00321828|Biological|bevacizumab|bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression
12035352|NCT00321828|Drug|fluorouracil|5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression
12035353|NCT00321828|Drug|leucovorin|leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
12035354|NCT00321828|Drug|oxaliplatin|Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
12035355|NCT00321815|Drug|PF-3512676 + Erlotinib|"PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity.
~Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity"
12035356|NCT00321815|Drug|Erlotinib|Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
12035357|NCT00321802|Drug|Simvastatin|Patients take 40 mg of simvastatin per day for 6 months.
12035358|NCT00321802|Drug|Placebo|Placebo
12035359|NCT00321789|Behavioral|spouse-assisted intervention|Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created monthly goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse created plans to support patient goal achievement.
12035360|NCT00321763|Biological|Candidate Influenza Vaccine GSK1247446A - 3 different formulations|Single dose, Intramuscular injection
12035361|NCT00321763|Biological|Fluarix TM|Single dose, Intramuscular injection
12035362|NCT00321750|Drug|1% pimecrolimus cream|
12035363|NCT00321737|Drug|Dexlansoprazole MR|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
12035364|NCT00321737|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
12035365|NCT00321737|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
12035366|NCT00321724|Drug|cediranib maleate|Given orally
12035367|NCT00321724|Other|laboratory biomarker analysis|Correlative studies
12035368|NCT00321711|Drug|Placebo|Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.
12035369|NCT00321711|Biological|AMG 531 (Romiplostim)|AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle treatment period, depending on randomization.
12035370|NCT00321711|Drug|Azacitidine|hypomethylating agent
12035371|NCT00321711|Drug|Decitabine|hypomethylating agent
12035372|NCT00321698|Radiation|Intensity-Modulated Radiation Therapy (IMRT)|Group 1=radiation only; All men in all Arms/Groups receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
12035373|NCT00321698|Drug|Docetaxel+IMRT|"Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation; Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
12035374|NCT00321685|Biological|Bevacizumab|Given IV
12035375|NCT00321685|Drug|Capecitabine|Given PO
12035376|NCT00321685|Drug|Fluorouracil|Given IV
12035377|NCT00321685|Drug|Leucovorin Calcium|Given IV
12035378|NCT00321685|Drug|Oxaliplatin|Given IV
12035379|NCT00321685|Radiation|Radiation Therapy|Undergo radiotherapy
12035380|NCT00321685|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
12035381|NCT00321672|Drug|NGX-4010, 8% capsaicin patch|Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.
12035382|NCT00321672|Drug|0.04% capsaicin patch|Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.
12035383|NCT00321672|Drug|NGX-4010, 8% capsaicin patch|Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.
12035384|NCT00321672|Drug|0.04% capsaicin patch|Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.
12035385|NCT00321659|Behavioral|Aerobic|3x/week of walking and cycling
12035386|NCT00321659|Behavioral|Strength training|3x/week of resistance training activities
12035387|NCT00321659|Behavioral|Combination|3x/week of aerobic and strength training activities
12035388|NCT00321659|Behavioral|FSHC|Biweekly group education group meetings
12035389|NCT00321646|Drug|Bevacizumab|Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center.
12035390|NCT00321646|Drug|Docetaxel|Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
12035391|NCT00321633|Drug|carboplatin|
12035392|NCT00321633|Drug|docetaxel|
12035393|NCT00321620|Drug|zoledronic acid|Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
12035394|NCT00321620|Biological|denosumab|Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes
12035395|NCT00321594|Drug|belinostat|Given IV
12035396|NCT00321581|Drug|Cediranib, AZD2171, RECENTIN|
12035397|NCT00321555|Drug|Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin|LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium Chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks.
12035888|NCT00317395|Drug|unfractionated heparin|intravenous administration
12035398|NCT00321542|Other|Imaging study, No intervention|Imaging with coronary computed tomographic angiography
12035399|NCT00321529|Device|motion analysis by durometer|
12035400|NCT00321516|Drug|aripiprazole|Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
12035401|NCT00321490|Drug|Quetiapine fumarate|
12035402|NCT00321490|Drug|Duloxetine|
12035403|NCT00321477|Drug|GW679769 oral tablets|
12035404|NCT00321464|Biological|Denosumab|Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes
12035405|NCT00321464|Drug|Zoledronic Acid|Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
12035406|NCT00321451|Behavioral|Cognitive behavioral therapy for insomnia|4 biweekly outpatient sessions with sleep psychologist
12035407|NCT00321451|Behavioral|Pseudo-desensitization procedure|4 biweekly outpatient visits with sleep psychologist
12035408|NCT00321451|Other|Usual care|3 outpatient visits with study physician
12035409|NCT00321425|Procedure|brachial plexus block|
12035410|NCT00321425|Procedure|ultrasound guidance|
12035411|NCT00321425|Procedure|electrical nerve stimulation|
12035412|NCT00321412|Drug|AST-120|oral, sachet, 2 grams three times daily for 8 weeks
12035413|NCT00321373|Biological|Candidate Influenza Vaccine GSK1247446A - 2 different formulations|Single dose, Intramuscular injection
12035414|NCT00321373|Biological|FluarixTM|Single dose, Intramuscular injection
12035415|NCT00321360|Drug|Propofol|
12035416|NCT00321360|Device|Patient maintained sedation|
12035417|NCT00321347|Drug|Lidocaine|
12035418|NCT00321334|Procedure|Chemotherapy+Surgery|Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles
12035419|NCT00321321|Drug|Sulfonylurea|
12035420|NCT00321308|Drug|pemetrexed|500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
12035421|NCT00321308|Drug|pemetrexed + PF-3512676|pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
12035422|NCT00321295|Device|Atrial synchronous bi-ventricular pacing|
12035423|NCT00321282|Procedure|Atrial Fibrillation|
12035424|NCT00321269|Behavioral|Single Illness Management|8 week nursing intervention addressing Congestive Heart Failure
12035425|NCT00321269|Behavioral|Comorbid Illness Management|8 week nursing intervention to address Congestive Heart Failure and emotional coping
12035426|NCT00321256|Procedure|human pancreatic islet transplantation|
12035427|NCT00321243|Behavioral|Visual clues|
12035428|NCT00321230|Drug|macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate|
12035429|NCT00321204|Procedure|TZD reducing the incidence of atrial arrhythmias|
12035430|NCT00321191|Drug|No nitrous oxide|
12035431|NCT00321191|Drug|Administration of N2O|
12035432|NCT00321178|Drug|SR4 - switch to CR4|switch to oral treatment after 4 weeks SR 'standard' therapy
12035433|NCT00321165|Drug|taurolidine|
12035434|NCT00321152|Other|6(S)-5-MTHF (a Medical Food)|The study consists of 8 visits over a period of 8 weeks or 60 days. Eligible participants will be randomized to double-blind treatment with placebo or Deplin (6(S)-5-MTHF). Participants will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. At the end of the double-blind phase, both responders and non-responders who have completed the 8 week study will have the option of receiving free, open-label adjunctive treatment with either 7.5 mg or 15 mg of 6(S)-5-MTHF for 12 months. Subjects who agree to receive open-label treatment with 6(S)-5-MTHF for 12 months will be assessed every three (3) months until the end of the follow-up phase.
12035435|NCT00321126|Drug|Children in the zinc group received 20 mg of elemental zinc as acetate per day in a twice-daily dose for two weeks.|
12035436|NCT00321113|Drug|tacrolimus|immunosuppression
12035437|NCT00321113|Drug|mycophenolate mofetil|oral
12035438|NCT00321113|Drug|steroids|oral
12035439|NCT00321100|Drug|bevacizumab|Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
12035440|NCT00321100|Drug|Cetuximab|Cetuximab 250mg/m2 IV weekly each 21 day cycle
12035441|NCT00321100|Drug|Oxaliplatin|Oxaliplatin 130mg/m2 IV day 1 every 21 days
12035442|NCT00321100|Drug|Capecitabine|Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
12035443|NCT00321087|Drug|T2000|Dose escalation from 600 to 1000 mg
12035444|NCT00321087|Drug|T2000|Placebo followed by T2000 dose escalation from 600 to 1000 mg
12035445|NCT00321087|Drug|T2000|Placebo followed by dose escalation from 600 to 1000
12035446|NCT00321074|Drug|TACROLIMUS|Immunosuppression
12035447|NCT00321061|Drug|VRC-HIVDNA016-00, VRC-HIVADV014-00|
12035448|NCT00321048|Device|Active Breathing Coordinator|A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
12035449|NCT00321035|Device|OculusGen Biodegradable Collagen Matrix Implant|
12035450|NCT00321022|Behavioral|Accelerated Diagnostic Protocol Emergency Department Observational Unit|
12035451|NCT00321009|Drug|Enoxaparin|
12035452|NCT00320983|Drug|Topotecan|Topotecan
12035453|NCT00320983|Drug|Cisplatin|Cisplatin
12035454|NCT00320970|Drug|Candesartan|
12035455|NCT00320957|Device|OculusGen Biodegradable Collagen Matrix Implant|
12035456|NCT00320931|Device|PET/CT|
12035457|NCT00320905|Behavioral|Observational|No intervention
12035458|NCT00320892|Drug|Atropine Sulphate 1% ophthalmic drops|Atropine Sulphate 1% ophthalmic drops will be used, by Fisher Pharmaceutical Labs, at a dose of 2 drops per administration
12035459|NCT00320879|Drug|irbesartan|
12035460|NCT00320866|Device|syringe driver|
12035461|NCT00320853|Drug|Vitamin D|
12035462|NCT00320827|Drug|CS-1008 (humanized anti-DR5 antibody)|
12035463|NCT00320814|Drug|VEGF Trap-Eye|single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
12035464|NCT00320801|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
12035465|NCT00320801|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
12035563|NCT00319956|Drug|Azithromycin|Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
12035466|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
12035467|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
12035468|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
12035469|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
12035470|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
12035471|NCT00320775|Drug|VEGF Trap|"Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye.
~Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later.
~Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap.
~After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap."
12035472|NCT00320762|Device|OculusGen Biodegradable Collagen Matrix Implant|
12035473|NCT00320749|Drug|Capecitabine|Will be give on days 8-21
12035474|NCT00320749|Drug|Docetaxel|Will be given on days 1 and 8,
12035475|NCT00320749|Drug|Gemcitabine|A fixed dose rate will be give on days 8 and 15.
12035476|NCT00320736|Drug|galantamine|
12035477|NCT00320723|Drug|bupropion, transdermal nicotine patch|
12035478|NCT00320710|Drug|Zoledronic acid|4mg IV
12035479|NCT00320710|Drug|Placebo|Placebo to zoledronic acid
12035480|NCT00320697|Drug|bupropion + nicotine patch + nicotine gum or lozenges|Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
12035481|NCT00320697|Drug|Placebo pill + placebo patch|Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
12035482|NCT00320671|Drug|Aripiprazole|The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
12035483|NCT00320671|Drug|Risperidone|The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
12035484|NCT00320658|Biological|MSP1 42-C1/Alhydrogel|Recombinant MSP1 42-C1/Alhydrogel vaccine (one of two doses)
12035485|NCT00320658|Biological|CPG 7909|Adjuvant
12035486|NCT00320632|Drug|Desipramine|
12035487|NCT00320619|Drug|Epsilon-Aminocaproic Acid (EACA)|Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
12035488|NCT00320619|Drug|Placebo|Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
12035489|NCT00320606|Drug|Immunosuppression Withdrawal|Gradual withdrawal of immunosuppressive medication. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks.
12035490|NCT00320593|Device|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
12035491|NCT00320593|Device|Single Vision Lenses (SVLs)|Single vision lenses
12035492|NCT00320580|Drug|norelgestromin/ethinyl estradiol|
12035493|NCT00320567|Drug|norgestimate/ethinyl estradiol|
12035494|NCT00320554|Behavioral|Durometer analysis|
12035495|NCT00320541|Drug|gemcitabine|1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
12035496|NCT00320541|Drug|paclitaxel|90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
12035497|NCT00320541|Drug|bevacizumab|10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
12035498|NCT00320528|Drug|atomoxetine|0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
12035499|NCT00320515|Drug|pemetrexed|"Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, intravenous (IV), every 21 days, until disease progression
~Phase 2 - 700 mg/m2, intravenous (IV), every 21 days, until disease progression"
12035500|NCT00320515|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days, until disease progression
12035501|NCT00320502|Drug|BXT-51072|
12035502|NCT00320489|Drug|olanzapine|10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
12035503|NCT00320489|Drug|olanzapine pamoate depot|405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
12035504|NCT00320476|Drug|Velcade|
12035505|NCT00320463|Biological|DTPa-HBV-IPV/Hib vaccine|
12035506|NCT00320450|Drug|SB-681323|
12035507|NCT00320424|Drug|Fondaparinux|
12035508|NCT00320411|Drug|lapatinib|Lapatinib 1500mg QD
12035509|NCT00320398|Drug|Fondaparinux|
12035510|NCT00320385|Drug|Lapatinib|oral lapatinib once daily
12035511|NCT00320385|Biological|Trastuzumab|IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose
12035564|NCT00319956|Drug|Placebo|vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
12035512|NCT00320359|Drug|Intravenous topotecan/cisplatin|"Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5.
~Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan."
12035513|NCT00320359|Drug|Intravenous etoposide/cisplatin|"Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid.
~Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3."
12035514|NCT00320346|Biological|Pandemic Influenza Vaccine|
12035515|NCT00320333|Procedure|pulmonary rehabilitation programme|
12035516|NCT00320320|Drug|Irinotecan|
12035517|NCT00320307|Drug|abacavir|
12035518|NCT00320294|Drug|irinotecan|
12035519|NCT00320294|Drug|cisplatin|
12035520|NCT00320281|Drug|botulinum toxin A|Injection of BTXA into cervical and upper back muscles based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit.Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.
12035521|NCT00320281|Other|placebo|Injection of normal saline into cervical and upper back muscles was also based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit. Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.
12035522|NCT00320268|Drug|Quetiapine fumarate|
12035523|NCT00320255|Drug|Apixaban|Oral tablets administered once daily in 5-, 10-, or 20-mg dose
12035524|NCT00320255|Drug|Placebo|Oral tablets administered once daily
12035525|NCT00320242|Device|1 mo baseline before visual cue|Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory
12035526|NCT00320229|Drug|abciximab|
12035527|NCT00320216|Drug|Ustekinumab|Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
12035528|NCT00320216|Drug|Placebo|Patients in the placebo group will receive placebo medication.
12035529|NCT00320203|Drug|Anecortave Acetate Sterile Suspension, 6 mg/mL|Single injection, anterior juxtascleral depot (AJD)
12035530|NCT00320203|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|Single injection, anterior juxtascleral depot (AJD)
12035531|NCT00320203|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|Single injection, anterior juxtascleral depot (AJD)
12035532|NCT00320203|Other|Anecortave Acetate Vehicle|Single injection, anterior juxtascleral depot (AJD)
12035533|NCT00320190|Drug|Imatinib|Imatinib tablets administered orally at a dose of 400 mg twice daily. Each 400- mg dose to be taken with a meal and a large glass of water.
12035534|NCT00320190|Drug|Dasatinib|Dasatinib tablets administered orally at a dose of 100 mg once daily.
12035535|NCT00320138|Procedure|Acupuncture, using Chinese Medicine methodology|4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments
12035536|NCT00320125|Dietary Supplement|Orange juice plus calcium|> 1,200mg Ca (four glasses of orange juice plus calcium)per day
12035537|NCT00320125|Dietary Supplement|Dairy products|> 1,200mg Ca (by consuming milk, yogurt, and cheese)
12035538|NCT00320112|Behavioral|Reciprocal Diabetes Peer Support Program|participants are paired with another age-matched participation. Paired peer partners were encouraged to talk weekly using a telephone platform that recorded call frequency and duration and provided automated reminders promoting peer contact.
12035539|NCT00320112|Behavioral|Nurse Case management|patients are not paired in the NCM arm attended a 1.5 hour session to receive education on care manager services and diabetes educational materials and be assigned to a nurse care manager with whom they were encouraged to follow-up regularly.
12035540|NCT00320112|Behavioral|group outpatient counseling visits|Participants in the peer group were also offered three optional 1.5 hour patient-driven group sessions at month 1, 3, and 6
12035541|NCT00320099|Drug|recombinant human insulin|intensive insulin therapy as a continuous infusion to maintain blood glucose levels between 4 and 6 mmol/l
12035542|NCT00320099|Drug|hydrocortisone|50 mg as iv bolus every 6 hours for 7 days
12035543|NCT00320099|Drug|fludrocortisone|50 µg once a day via a nasogastric tube for seven days
12035544|NCT00320099|Drug|Hydrocortisone|hydrocortisone 50mg q6 for 7 days
12035545|NCT00320073|Drug|erlotinib hydrochloride|75 mg to 150mg
12035546|NCT00320073|Drug|pemetrexed disodium|Pemetrexed is administered intravenously over 10 minutes, every 21 days
12035547|NCT00320073|Drug|vinflunine|Vinflunine is administered intravenously over 20 minutes and should be given after pemetrexed, every 21 days
12035548|NCT00320060|Drug|Pyridorin (pyridoxamine dihydrochloride)|
12035549|NCT00320047|Drug|Baclofen|Participants will take baclofen 3 times a day, before meals, for 10 weeks. Baclofen dosages will be low to begin, followed by a gradual increase over a 2-week period. Upon reaching the maximum tolerated dose of baclofen, participants will continue at this dosage level until Week 11, at which time the dose will be gradually decreased. If any serious side effects occur, baclofen dosage will be decreased to the previous tolerated dosage level.
12035550|NCT00320034|Drug|R-albuterol, S-albuterol|
12035551|NCT00320021|Drug|Pyridorin (pyridoxamine dihydrochloride)|
12035552|NCT00320008|Behavioral|Diet|
12035553|NCT00320008|Behavioral|Exercise|
12035554|NCT00320008|Behavioral|Stop smoking|
12035555|NCT00320008|Drug|Glucose lowering therapy|
12035556|NCT00320008|Drug|Blood pressure lowering therapy|
12035557|NCT00320008|Drug|Lipid lowering therapy|
12035558|NCT00319995|Drug|loratadine; montelukast|
12035559|NCT00319982|Drug|Diltiazem|Sustained release formulation titrated to a target dose of 360 mg daily, or a maximum of 5 mg/kg/day in pediatric subjects for the duration of the study period
12035560|NCT00319982|Drug|Placebo|Placebo comparator (double-blind allocation of study medication)
12035561|NCT00319969|Drug|Amrubicin|Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
12035562|NCT00319969|Drug|Topotecan|Topotecan 1.5mg/m<2> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
12035565|NCT00319943|Procedure|Computer-based training for Mild Cognitive Impairment (MCI)|
12035566|NCT00319930|Drug|CNF1010 (17-AAG)|
12035567|NCT00319917|Drug|tacrolimus|oral
12035568|NCT00319917|Drug|placebo|oral
12035569|NCT00319891|Procedure|Computer-based Cognitive Training|
12035570|NCT00319878|Drug|Sirolimus|"Oral loading dose followed by a once daily dose:
~Cohort 1: Loading Dose - 1.2 mg; Daily Dose - 0.4 mg
~Cohort 2: % Dose Increase - 100%; Loading Dose - 2.4 mg; Daily Dose - 0.8 mg
~Cohort 3: % Dose Increase - 67%; Loading Dose - 3.9 mg; Daily Dose - 1.3 mg
~Cohort 4: % Dose Increase - 50%; Loading Dose - 6.0 mg; Daily Dose - 2.0 mg"
12035571|NCT00319878|Drug|Cyclosporine|Dose of 5 mg/kg divided as a twice daily oral dose
12035572|NCT00319865|Drug|Velcade|
12035573|NCT00319865|Drug|Thalidomide|
12035574|NCT00319865|Drug|Adriamycin|
12035575|NCT00319865|Drug|Dexamethasone|
12035576|NCT00319852|Biological|DTaP-IPV combined vaccine|0.5 mL, IM
12035577|NCT00319852|Biological|DTaP vaccine|0.5 mL, IM
12035578|NCT00319839|Drug|Abraxane|260 mg/m2 IV over 30 minutes every 3 weeks
12035579|NCT00319839|Drug|Cetuximab|Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles
12035580|NCT00319826|Other|No intervention|This is an observational study with no intervention
12035581|NCT00319813|Behavioral|Education|
12035582|NCT00319800|Drug|Gefitinib|
12035583|NCT00319800|Drug|Irinotecan|
12035584|NCT00319787|Drug|Iressa|
12035585|NCT00319774|Device|Hemocontrol Biofeedback System|
12035586|NCT00319761|Drug|Calcitriol|
12035587|NCT00319748|Drug|852A|0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
12035588|NCT00319735|Procedure|Radiation Therapy|External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
12035589|NCT00319735|Procedure|Surgery|Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
12035590|NCT00319735|Procedure|Tissue Sample|For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
12035591|NCT00319709|Drug|SR58611A|
12035592|NCT00319696|Drug|Bosentan 62.5 mg|Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose)
12035593|NCT00319696|Drug|Bosentan 125 mg|Bosentan 125-mg oral tablets administered b.i.d. (target dose)
12035594|NCT00319683|Drug|ADH300004|
12035595|NCT00319670|Drug|MiraLax|
12035596|NCT00319657|Biological|Hematopoietic cell transplantation|Transplantation of hematopoietic stem cells from the living donor.
12035597|NCT00319657|Radiation|Total lymphoid irradiation|Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.
12035598|NCT00319644|Device|Bronchoalveolar lavage|Using catheter to obtain respiratory sample
12035599|NCT00319618|Drug|Gefitinib|
12035600|NCT00319618|Drug|Docetaxel|
12035601|NCT00319605|Drug|Levetiracetam|
12035602|NCT00319592|Biological|ChimeriVax™-JE vaccine|0.5 mL, subcutaneously
12035603|NCT00319592|Biological|JE-VAX® vaccine|1.0 mL, subcutaneously
12035604|NCT00319566|Drug|Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily|
12035605|NCT00319553|Biological|ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed|0.5 mL, IM
12035606|NCT00319553|Biological|BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed|0.5 mL, IM
12035607|NCT00319540|Behavioral|Control with depression course (CWD)|
12035608|NCT00319514|Drug|Docetaxel|
12035609|NCT00319501|Drug|Placebo|Intramuscular autoinjector; administered at onset of an episode
12035610|NCT00319501|Drug|Vanquix Auto-Injector (Diazepam Injection)|Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode
12035611|NCT00319488|Drug|Inhaled Corticosteroid (Budesonide)|Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms.
12035612|NCT00319488|Drug|Leukotriene Receptor Antagonist (Montelukast Sodium)|Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms.
12035613|NCT00319488|Drug|Inhaled Albuterol|All participants will receive inhaled albuterol treatments four times a day.
12035614|NCT00319475|Procedure|AAA or AF/IB (end-to-end) in patients with Leriche Syndrome|
12035615|NCT00319462|Device|hemoclip|
12035616|NCT00319449|Drug|Ezetimibe|10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin
12035617|NCT00319449|Drug|Placebo|10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin
12035618|NCT00319449|Drug|Atorvastatin 10 mg|10 mg/day atorvastatin, orally, (ongoing treatment in participants)
12035619|NCT00319436|Behavioral|Mentalizing Therapy for Substance Using Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
12035676|NCT00318890|Drug|Docetaxel|Docetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy.
12035889|NCT00317395|Drug|eptifibatide|intravenous administration
12035620|NCT00319436|Behavioral|Standard Parent Education for Substance Using Mothers|This 12 session comparison was designed to match the experimental intervention on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
12035621|NCT00319423|Procedure|Patient education and supervised exercise|Patient education: 3 sessions Supervised exercise: 2-3 times/week for 12 weeks
12035622|NCT00319410|Procedure|vaginoscopic hysteroscopy|
12035623|NCT00319397|Behavioral|Exercise-Training Program|
12035624|NCT00319384|Device|Ultrafiltration therapy|
12035625|NCT00319358|Dietary Supplement|Antioxidants|600microgm selenium, 0.54g vitamin C, 9000IU beta-carotene, 270IU vitamin E, 2g methionine per day, daily, in divided doses for 6 months
12035626|NCT00319358|Dietary Supplement|Placebo|placebo
12035627|NCT00319345|Drug|Mannitol, Sodium-Lactate|
12035628|NCT00319332|Drug|Ibritumomab Tiuxetan|
12035629|NCT00319332|Drug|Iodine I 131 Tositumomab|
12035630|NCT00319319|Drug|Mecamylamine hydrochloride (Inversine)|
12035631|NCT00319306|Drug|Budesonide/formoterol|
12035632|NCT00319306|Device|Symbicort® Turbohaler®|
12035633|NCT00319293|Drug|Metformin|
12035634|NCT00319280|Procedure|bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)|Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control
12035635|NCT00319267|Drug|Bosentan|Pediatric oral formulation of bosentan, i.e., 32 mg dispersible and breakable tablets
12035636|NCT00319254|Drug|SKI-606 (Bosutinib)|SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
12035637|NCT00319241|Behavioral|Parenting Intervention|
12035638|NCT00319228|Drug|Plasma-derived AT-III concentrate|"Segment I: A single dose IV infusion of 50 IU/kg of ATIII-DAF/DI will be administered to each patient.
~Segment II: A single dose or multiple doses depending on the subject's ATIII plasma levels and patient's specific treatment plan."
12035639|NCT00319215|Drug|Ramelteon 8 mg|
12035640|NCT00319215|Drug|Zopiclone 7.5 mg|
12035641|NCT00319202|Drug|Candesartan|32 mg/d for 6 months
12035642|NCT00319202|Drug|Placebo|Placebo administration for 6 months
12035643|NCT00319189|Drug|Nateglinide|
12035644|NCT00319163|Drug|levonorgestrel/ethinyl estradiol|
12035645|NCT00319150|Drug|erythropoietin|Decrease dosage by 12.5% q 2 weeks according to an algorithm.
12035646|NCT00319137|Drug|GW274150|
12035647|NCT00319111|Drug|bosentan|"Oral bosentan
~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
12035648|NCT00319098|Biological|Adjuvanted pandemic influenza candidate vaccine|2 doses, intramuscular injection
12035649|NCT00319098|Biological|Fluarix|One intramuscular injection
12035650|NCT00319098|Biological|Placebo|One intramuscular injection
12035651|NCT00319085|Procedure|Total hip replacement (Preheating of femur stem)|Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
12035652|NCT00319072|Behavioral|TalkToYourDoc(sm) hormone therapy module|
12035653|NCT00319059|Drug|systemic administration of 99mTc-HYNIC-Annexin A5|
12035654|NCT00319059|Behavioral|10 minutes of ischemic handgripping|
12035655|NCT00319046|Drug|Miglustat|Oral capsules containing miglustat 100 mg, administered three times daily (t.i.d.)
12035656|NCT00319033|Drug|bosentan|
12035657|NCT00319020|Drug|Bosentan|32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally
12035658|NCT00319007|Drug|Sulindac (drug)|
12035659|NCT00319007|Drug|VSL#3 (probiotic)|
12035660|NCT00319007|Drug|Inulin (probiotic)|
12035661|NCT00318994|Drug|Meropenem|
12035662|NCT00318981|Drug|Concerta|
12035663|NCT00318968|Drug|Esomeprazole|
12035664|NCT00318955|Drug|Dexmedetomidine|
12035665|NCT00318955|Drug|Propofol|
12035666|NCT00318942|Drug|Crystalloids|Isotonic or hypertonic saline or Ringer Lactate or any other crystalloids, at the necessary dose to restore hemodynamic for all ICU stay
12035667|NCT00318942|Drug|Colloids|Gelatines, Albumine, Starch, or any other colloids, at the necessary dose to restore hemodynamic (starch cumulative daily dose should not exceed 35/40 ml/kg), for all ICU stay
12035668|NCT00318942|Drug|Crystalloids|Any crystalloids given for correction of hypovolemia during all ICU stay
12035669|NCT00318942|Drug|Colloids|Any colloids given for correction of hypovolemia during all ICU stay
12035670|NCT00318929|Drug|Divalproex Sodium Extended-Release Tablets|Once a day dosing
12035671|NCT00318903|Drug|Irinotecan (drug)|50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
12035672|NCT00318903|Drug|Taxotere (drug)|Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
12035673|NCT00318903|Procedure|Radiotherapy (procedure)|Radiotherapy will be given in 28 fractions over 5-6 weeks at 1.8 Gy per fraction for a total of 50.4 Gy. This will begin concurrently with chemotherapy on Day 29 of treatment.
12035674|NCT00318903|Procedure|Esophagectomy (procedure)|After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.
12035675|NCT00318890|Drug|Cisplatin|Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.
12035805|NCT00317811|Dietary Supplement|ascorbic acid|
12035677|NCT00318890|Procedure|Radiotherapy|Radiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin.
12035678|NCT00318890|Drug|Amifostine|Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.
12035679|NCT00318877|Behavioral|After school team sports program|
12035680|NCT00318877|Behavioral|After school health education program|
12035681|NCT00318864|Behavioral|Cognitive behavioral therapy|
12035682|NCT00318851|Device|Carotid Stent with Distal Protection Device|Carotid Stent Placement with Distal Protection
12035683|NCT00318838|Drug|Azimilide dihydrochloride|125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
12035684|NCT00318838|Drug|Placebo|Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days
12035685|NCT00318825|Drug|Nitrous oxide|
12035686|NCT00318812|Drug|Heme Iron Polypeptide (Proferrin)|Heme iron polypeptide 11mg po tid for 6 months
12035687|NCT00318812|Drug|Iron sucrose (Venofer)|Iron sucrose infusion IV q month x 6 months
12035688|NCT00318799|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658ID)|per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo
12035689|NCT00318799|Drug|SH D01155E|per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo
12035690|NCT00318786|Drug|biphasic insulin aspart|
12035691|NCT00318773|Drug|sertraline|50 - 100 mg daily for 2 weeks before each menses for 4 months or 12 months and then switched to placebo.
12035692|NCT00318760|Drug|Clonidine|0.1 or 0.2 mg oral, one dose
12035693|NCT00318760|Drug|Placebo|oral capsule 1 dose
12035694|NCT00318747|Drug|Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)|
12035695|NCT00318721|Device|Long Lasting Impregnated Nets (LLIN)|Distribution of LLIN in selected clusters
12035696|NCT00318708|Drug|clarithromycin|clarithromycin 500 mg twice daily (Biaxin)
12035697|NCT00318708|Drug|fluticasone propionate|fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
12035698|NCT00318708|Drug|placebo clarithromycin|placebo clarithromycin twice daily
12035699|NCT00318695|Dietary Supplement|Probiotics|Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
12035700|NCT00318695|Other|Placebo|Commercially available cow's milk based infant formula without probiotic supplementation
12035701|NCT00318682|Device|FIBROSCAN|diagnostic examination of the hepato fibrosis
12035702|NCT00318669|Drug|Paroxetine hydrochloride hydrate|
12035703|NCT00318656|Drug|rosiglitazone-metformin fixed dose combination|
12035704|NCT00318656|Drug|metformin + glimepiride|
12035705|NCT00318643|Drug|Mitomycin C|intravesical administration
12035706|NCT00318643|Drug|Chemophase|intravesical administration
12035707|NCT00318630|Drug|Rosiglitazone|Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.
12035708|NCT00318630|Drug|Placebo|Subjects will also receive placebo oral tablet.
12035709|NCT00318617|Drug|GW510516X|
12035710|NCT00318591|Device|SpeediCath|hydrophilic coated urinary intermittent catheter
12035711|NCT00318591|Device|Conveen Uncoated|Uncoated urinary intermittent catheter
12035712|NCT00318565|Device|RF energy delivery for treatment of Typical Atrial flutter|Navistar ThermoCool catheter
12035713|NCT00318552|Drug|Meropenem|
12035714|NCT00318539|Drug|Quetiapine|
12035715|NCT00318513|Drug|Bevacizumab|
12035716|NCT00318500|Drug|ERB-041|
12035717|NCT00318487|Procedure|Bilateral sinus augmentation with immediately loaded dental implants|Bilateral sinus augmentation with immediately loaded dental implants will be used.
12035718|NCT00318474|Drug|Mycophenolate Mofetil (MMF)|Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.
12035719|NCT00318474|Drug|MMF Placebo|Placebo only, oral administration
12035720|NCT00318474|Drug|ACEi|Administer same as pre-treatment regimen.
12035721|NCT00318474|Drug|FOS|Administer same as pre-treatment regimen
12035722|NCT00318461|Drug|liraglutide|0.6 mg for s.c. (under the skin) injection.
12035723|NCT00318461|Drug|metformin|1.5-2.0 g tablets
12035724|NCT00318461|Drug|glimepiride|4 mg tablets
12035725|NCT00318461|Drug|placebo|Glimepiride placebo 1 mg and 2 mg tablets
12035726|NCT00318461|Drug|placebo|Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
12035727|NCT00318461|Drug|liraglutide|1.2 mg for s.c. (under the skin) injection
12035728|NCT00318461|Drug|liraglutide|1.8 mg for s.c. (under the skin) injection
12035729|NCT00318448|Drug|Zolpidem (SL800750)|
12035730|NCT00318435|Device|Stent or stent-graft deployment|
12035731|NCT00318422|Drug|liraglutide|
12035732|NCT00318422|Drug|rosiglitazone|
12035733|NCT00318422|Drug|glimepiride|
12035734|NCT00318409|Drug|Bupropion|
12035735|NCT00318409|Drug|Placebo|
12035736|NCT00318396|Procedure|Bone preparation technique: compaction|The bone is pressed very hard together before implantation of femoral component.
12035737|NCT00318396|Procedure|Bone preparation technique: conventional technique|Bone is broached before implantation of femoral component.
12035738|NCT00318383|Biological|NicVAX conjugate vaccine|200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel
12035739|NCT00318383|Biological|Placebo|Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months
12035740|NCT00318370|Drug|Farletuzumab|Weekly Farletuzumab infusions Dose dependent on dosing group
12035741|NCT00318370|Drug|Chemo Plus Far|Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
12035742|NCT00318357|Device|Continuation of CRT|Implantation of CRT device and medical treatment according normal hospital routine.
12035806|NCT00317811|Drug|bortezomib|
12035807|NCT00317811|Drug|melphalan|
12035743|NCT00318357|Device|Upgrade to CRT|Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.
12035744|NCT00318344|Drug|Atuna Racemosa|
12035745|NCT00318331|Drug|Glutamine|Group A patients will receive 0.5g/kg/day of enteral glutamine daily while they are receiving tube feeds or at the end of 28 days (whichever comes first)
12035746|NCT00318318|Drug|Premarin|
12035747|NCT00318292|Drug|bupivacaine and epinephrine|20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.
12035748|NCT00318292|Drug|Placebo|20 ml normal saline injection.
12035749|NCT00318279|Device|Surgical simulator to practice vascular anastomosis|
12035750|NCT00318266|Device|Nuclear Matrix Protein 22 Urine sample kit|Urine sample obtained from patient will be tested with the NMP22 sample kit to see if it can detect bladder cancer.
12035751|NCT00318253|Procedure|cranberry juice|
12035752|NCT00318240|Device|High Intensity Focused Ultrasound|Treatment of Radiation failure in Prostate Cancer
12035753|NCT00318227|Procedure|Blood Transfusion|Blood transfusion will be administered when the transfusion trigger is met.
12035754|NCT00318214|Drug|MRE0094|Gel, 500 mcg/g once each day
12035755|NCT00318214|Drug|Vehicle gel|Gel administered once per day
12035756|NCT00318201|Drug|Erythromycin|
12035757|NCT00318201|Drug|Diltiazem|
12035758|NCT00318188|Procedure|standardized reeducation and readaptation program|
12035759|NCT00318175|Drug|Bosentan (Tracleer)|
12035760|NCT00318162|Drug|low dose naltrexone|
12035761|NCT00318149|Biological|Fluarix|1 dose administered intramuscularly in the deltoid region of the non-dominant arm
12035762|NCT00318149|Biological|Fluarix-AS25|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
12035763|NCT00318149|Biological|Fluarix-AS50|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
12035764|NCT00318149|Biological|Fluarix-AS01B|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
12035765|NCT00318149|Biological|Fluarix-AS01E|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
12035766|NCT00318136|Drug|Bevacizumab|15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
12035767|NCT00318136|Drug|Carboplatin|Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
12035768|NCT00318136|Drug|Paclitaxel|Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
12035769|NCT00318123|Drug|Kivexa|abacavir 600mg + lamivudine 300mg in one tablet QD
12035770|NCT00318110|Procedure|NST using MUD for metastatic renal cell carcinoma|"Preparative regimen:
~Fludarabine 25 mg/m2 IV once a day x 5 days (-6,-5,-4,-3,-2) Melphalan 70 mg/m2 IV once a day x 2 days (-3,-2) Donor Stem Cell Infusion: Stem cells will be infused on day 0 GVHD prophylaxis: Tacrolimus and methotrexate 5 mg/m2 IV day 1, 3, 6 and 11"
12035771|NCT00318084|Drug|Esomeprazole|
12035772|NCT00318084|Procedure|Ambulatory 24-hour esophageal pH-monitoring|
12035773|NCT00318071|Device|Merci Retriever|"For patients eligible to participate in the trial, the operating physician initiated treatment with the Merci L5 Retriever to remove large vessel thrombotic occlusion and recanalization of the vessel. Subsequent treatment could be made with Merci X6 or X5 Merci Retrievers.
~Large vessel arteries are defined as internal carotid, middle cerebral M1/M2 segments, basilar, and vertebral arteries.
~Recanalization was defined as TIMI II or TIMI III per angiography."
12035774|NCT00318058|Biological|influenza vaccine Fluarix, Adjuvanted Fluarix|
12035775|NCT00318045|Device|Eyeglass lenses|
12035776|NCT00318032|Drug|multi-factorial intervention|
12035777|NCT00318019|Dietary Supplement|OPC Factor(TM)|Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.
12035778|NCT00318019|Other|Placebo|Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.
12035779|NCT00318006|Procedure|saline irrigation|subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).
12035780|NCT00318006|Procedure|saline spray|subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).
12035781|NCT00317993|Drug|ezetimibe|
12035782|NCT00317993|Drug|simvastatin|
12035783|NCT00317993|Drug|ezetimibe plus simvastatin|
12035784|NCT00317980|Drug|Meglumine antimoniate|Meglumine antimoniate 5mg/kg/d for 20 days
12035785|NCT00317980|Drug|Meglumine antimoniate|Meglumine antimoniate 15 mg/kg/d for 20 days
12035786|NCT00317967|Drug|Atorvastatin|80 mg pills daily
12035787|NCT00317967|Drug|Placebo|80 mg pills daily
12035788|NCT00317954|Drug|Spironolactone|
12035789|NCT00317941|Drug|Betaferon/Betaseron|250ug administrated with Betaject
12035790|NCT00317941|Drug|Rebif|44ug administered with Rebiject II
12035791|NCT00317941|Drug|Betaferon/Betaseron|250ug administrated with Betaject light
12035792|NCT00317928|Drug|Metformin|
12035793|NCT00317915|Drug|Irbesartan treatment|
12035794|NCT00317902|Drug|Epoetin alfa|
12035795|NCT00317889|Procedure|Bone preparation technique: compaction|
12035796|NCT00317889|Procedure|Bone preparation technique: broaching|
12035797|NCT00317876|Drug|cyclophosphamide|
12035798|NCT00317876|Drug|cyclosporine|
12035799|NCT00317876|Drug|methotrexate|
12035800|NCT00317876|Procedure|allogeneic bone marrow transplantation|
12035801|NCT00317876|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
12035802|NCT00317850|Drug|Gabapentin (Neurontin)|
12035803|NCT00317837|Procedure|Unipolar Hemiarthroplasty of the hip joint|Unipolar Hemiarthroplasty of the hip joint
12035804|NCT00317837|Procedure|bipolar hemiarthroplasty|bipolar hemiarthroplasty
12035808|NCT00317798|Biological|anti-thymocyte globulin|Escalating doses of rATG,intravenously, starting at 6 mg/kg to a maximum of 14.5 mg/kg. Rapamycin is given orally, starting at a dose of 1 mg daily beginning on day 1 and terminating on day 30. The dose of rapamycin was adjusted to maintain a constant blood level of 4-6 ng/ml in all subjects
12035809|NCT00317798|Drug|sirolimus|escalating doses of rATG, intravenously, starting at 6 mg/kg to a maximum of 14.5 mg/kg. Rapamycin is given orally, starting at a dose of 1 mg daily beginning on day 1 and terminating on day 30. The dose of rapamycin was adjusted to maintain a constant blood level of 4-6 ng/ml in all subjects
12035810|NCT00317785|Drug|cyclophosphamide|
12035811|NCT00317785|Drug|cyclosporine|
12035812|NCT00317785|Drug|methotrexate|
12035813|NCT00317785|Drug|mycophenolate mofetil|
12035814|NCT00317785|Drug|sirolimus|
12035815|NCT00317785|Drug|tacrolimus|
12035816|NCT00317785|Other|pharmacological study|
12035817|NCT00317785|Procedure|allogeneic bone marrow transplantation|
12035818|NCT00317785|Procedure|allogeneic hematopoietic stem cell transplantation|
12035819|NCT00317785|Procedure|peripheral blood stem cell transplantation|
12035820|NCT00317785|Radiation|total-body irradiation|
12035821|NCT00317772|Drug|Topotecan|"Phase I Starting Dose: 2 mg/m^2 by vein Weekly Over 30 Minutes on Days 1, 8, and 15.
~Phase II: MTD dose from Phase I by vein weekly on Days 1, 8, and 15."
12035822|NCT00317772|Drug|Gefitinib|"Phase I: 250 mg by mouth daily for 28 Days.
~Phase II: 250 mg by mouth daily for 28 Days."
12035823|NCT00317759|Biological|therapeutic autologous lymphocytes|
12035824|NCT00317759|Drug|fludarabine phosphate|
12035825|NCT00317746|Drug|Citalopram|
12035826|NCT00317746|Drug|Placebos|
12035827|NCT00317733|Drug|Ketoprofen in Transfersome|
12035828|NCT00317720|Drug|Trastuzumab|"Loading dose = 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle.
~If participant on trastuzumab at time of registration, loading dose deferred and received maintenance dose (6 mg/kg every 3 weeks). If the last trastuzumab dose was given 1 week (for participants receiving 2 mg/kg/week), or 3 weeks before registration (for participants receiving 6 mg/kg every 3 weeks), a loading dose (8 mg/kg) was given followed by maintenance dose."
12035829|NCT00317720|Drug|RAD001|Starting dose 10 mg by mouth daily. Phase I dose finding from two dose levels of daily RAD001 (5 and 10 mg).
12035830|NCT00317707|Drug|N-3 Polyunsaturated Fatty Acids|Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
12035831|NCT00317707|Drug|Placebo: Olive oil|Each subject assigned to the control group will receive 1 g/day capsule of olive oil.
12035832|NCT00317694|Drug|Fermagate|Film coated tablet 500mg
12035833|NCT00317694|Drug|Placebo|Oral administration, film coated tablet, 0mg
12035834|NCT00317681|Drug|Tacrolimus ointment|
12035835|NCT00317655|Drug|Glucosamine sulphate|
12035836|NCT00317655|Drug|Ginger|
12035837|NCT00317655|Drug|Ginger-Avocado-Soya|
12035838|NCT00317655|Drug|Ginger-ibuprofen|
12035839|NCT00317642|Drug|clofarabine (IV formulation)|clofarabine (IV formulation) infusion 40mg/m^2 / day up to 3 cycles
12035840|NCT00317642|Drug|placebo|placebo (sodium Chloride) 1-hour IV infusion
12035841|NCT00317642|Drug|cytarabine|cytarabine IV infusion 1g/m^2/day for up to 3 cycles
12035842|NCT00317629|Drug|controlled nitric oxide releasing patch|daily nitric oxide patch application during 20 days
12035843|NCT00317629|Drug|meglumine antimoniate|20mg/kg daily during 20 days
12035844|NCT00317603|Biological|Autologous, Lethally Irradiated Breast Cancer Cells|Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out
12035845|NCT00317590|Device|Rapid Diagnostic Test for Malaria (Paracheck®)|
12035846|NCT00317577|Drug|brimonidine, timolol|
12035847|NCT00317551|Device|Aberration controlled contact lens|
12035848|NCT00317551|Behavioral|Vision training|
12035849|NCT00317538|Drug|infliximab, etanercept|
12035850|NCT00317525|Device|Spectacle Lenses|
12035851|NCT00317512|Procedure|Percutaneous Coronary Revascularization|
12035852|NCT00317512|Drug|Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)|
12035853|NCT00317512|Drug|Voluven|
12035854|NCT00317499|Other|Placebo|Placebo
12035855|NCT00317499|Drug|Etanercept|Etanercept
12035856|NCT00317486|Drug|bosentan|
12035857|NCT00317473|Biological|FMP1/AS02A Malaria vaccine|Subjects vaccinated with FMP1/AS02 vaccine
12035858|NCT00317473|Biological|Imovax Rabies vaccine|Subjects vaccinated on corresponding FMP1/AS02A vaccination days
12035859|NCT00317460|Other|Physician Management|Standard physician care
12035860|NCT00317460|Behavioral|Counseling|Physician Management and Counseling
12035861|NCT00317447|Drug|Oral Prednisone|
12035862|NCT00317434|Drug|lapatinib|
12035863|NCT00317421|Drug|Sildenafil citrate|
12035864|NCT00317408|Biological|anti-thymocyte globulin|
12035865|NCT00317408|Drug|busulfan|
12035866|NCT00317408|Drug|carboplatin|
12035867|NCT00317408|Drug|carmustine|
12035868|NCT00317408|Drug|cyclosporine|
12035869|NCT00317408|Drug|cytarabine|
12035870|NCT00317408|Drug|dexamethasone|
12035871|NCT00317408|Drug|etoposide phosphate|
12035872|NCT00317408|Drug|idarubicin|
12035873|NCT00317408|Drug|ifosfamide|
12035874|NCT00317408|Drug|leucovorin calcium|
12035875|NCT00317408|Drug|lomustine|
12035876|NCT00317408|Drug|melphalan|
12035877|NCT00317408|Drug|methotrexate|
12035878|NCT00317408|Drug|mitoxantrone hydrochloride|
12035879|NCT00317408|Drug|prednisolone|
12035880|NCT00317408|Drug|thiotepa|
12035881|NCT00317408|Drug|vinblastine sulfate|
12035882|NCT00317408|Drug|vindesine|
12035883|NCT00317408|Procedure|allogeneic hematopoietic stem cell transplantation|
12035884|NCT00317408|Procedure|autologous hematopoietic stem cell transplantation|
12035885|NCT00317408|Procedure|peripheral blood stem cell transplantation|
12035886|NCT00317408|Radiation|total-body irradiation|
12035887|NCT00317395|Drug|Otamixaban (XRP0673)|intravenous administration
12035890|NCT00317382|Device|Ultrasound|Ultrasound used to visualize spine to determine best location for lumbar puncture.
12035891|NCT00317369|Drug|OPC-6535(Tetomilast)|
12035892|NCT00317356|Drug|OPC-6535(Tetomilast)|
12035893|NCT00317343|Drug|Bivalirudin (thrombin specific anticoagulant)|Percutaneous Coronary Intervention
12035894|NCT00317330|Drug|Isoniazid|
12035895|NCT00317330|Drug|Pyrazinamide|
12035896|NCT00317330|Drug|Rifampin|
12035897|NCT00317317|Procedure|Acupuncture|4 acupuncture treatments will be conducted during the IVF cycle. The 1st one is at the beginning of egg stimulation, the 2nd one is before the egg retrieval, the 3rd and 4th one are before and after the embryo transfer
12035898|NCT00317304|Behavioral|Mindfulness-based stress reduction|MBSR is an 8-week group-based program of training in mindfulness and its application to the stresses and challenges of everyday life
12035899|NCT00317291|Procedure|Acupuncture/Moxibustion|Acupuncture/Moxibustion: 16 scheduled sessions
12035900|NCT00317291|Other|Sham acupuncture/Placebo moxibustion|Sham acupuncture/Placebo moxibustion: 16 scheduled sessions
12035901|NCT00317278|Other|massage therapy|massage therapy to stable preterm infants
12035902|NCT00317278|Other|Sham|Sham (placebo) provided to the control group
12035903|NCT00317265|Procedure|Coronary bypass surgery|
12035904|NCT00317252|Drug|Hold ACEI or ARB|Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-96 hours post-catheterization (after creatinine measurement)
12035905|NCT00317239|Drug|Ferrous Sulfate tablets|325 mg/TID x 8 weeks
12035906|NCT00317239|Drug|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
12035907|NCT00317226|Drug|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
12035908|NCT00317213|Drug|LIBERTAL- a phospholipid mixture|
12035909|NCT00317200|Drug|Paclitaxel|Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
12035910|NCT00317200|Drug|Bevacizumab|Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle
12035911|NCT00317187|Biological|Tritanrix-HepB/Meningitec conjugate vaccine|The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
12035912|NCT00317187|Biological|Tritanrix/Hiberix vaccine|The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
12035913|NCT00317174|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
12035914|NCT00317161|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
12035915|NCT00317148|Drug|Placebos|Placebo capsule
12035916|NCT00317148|Drug|DHEA capsule|One capsule of DHEA
12035917|NCT00317135|Biological|Tritanrix-HepB/Meningitec conjugate vaccine|The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
12035918|NCT00317135|Biological|Tritanrix/Hiberix vaccine|The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
12035919|NCT00317122|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
12035920|NCT00317109|Biological|Tritanrix™- HepB|One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
12035921|NCT00317109|Biological|Hiberix™|One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
12035922|NCT00317109|Biological|Mencevax™ ACW|One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
12035923|NCT00317096|Procedure|FCM|Active comparator: Chemotherapy
12035924|NCT00317096|Procedure|R-FCM|experimental: Chemotherapy with additional rituximab
12035925|NCT00317096|Drug|rituximab maintenance|2 courses of rituximab maintenance after completion of salvage therapy
12035926|NCT00317096|Other|observation only|no Intervention after completion of FCM or R-FCM
12035927|NCT00317083|Procedure|Cough reflex test|
12035928|NCT00317070|Drug|dimethyl sulfoxide|intravesical installation 50 ml
12035929|NCT00317070|Drug|IC Cocktail|"Heparin 10,000 units
~Gentamicin 80 mg
~Hydrocortisone sodium succinate (Solucortef) 100 mg
~Lidocaine hydrochloride 1% 10 ml
~Sodium Bicarbonate 8.4% 5 ml"
12035930|NCT00317057|Procedure|Patient education and disease management|
12035931|NCT00317044|Drug|Esomeprazole|Esomeprazole 40 mg twice daily
12035932|NCT00317044|Drug|Esomeprazole|Esomeprazole 40 mg once daily
12035933|NCT00317044|Drug|Placebo|Placebo twice daily
12035934|NCT00317031|Drug|Acamprosate or Naltrexone|mg&d 90 days
12036001|NCT00316693|Biological|Aimmugen™|Intramuscular injection, 3 doses
12036002|NCT00316680|Biological|Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine|
12036003|NCT00316654|Biological|Meningococcal C conjugate vaccine|
12036004|NCT00316641|Drug|Lipid-lowing Tea|
12036005|NCT00316628|Biological|influenza vaccine|
12036006|NCT00316615|Biological|influenza vaccine|
12036007|NCT00316602|Biological|IMVAMUNE|Subjects receiving two subcutaneous vaccinations
12036110|NCT00315718|Drug|Extract from Hintonia latiflora bark|
12035935|NCT00317018|Behavioral|Evidence-Based Quality Improvement|The implementation intervention is known as Evidence-Based Quality Improvement (EBQI). EBQI is an adaptation of the Plan-Do-Study-Act cycles of Continuous Quality Improvement that emphasizes empirical evidence and the involvement of clinical and implementation experts (i.e., researchers). In the EBQI implementation intervention, both researchers (clinical and implementation experts) and local staff participate fully in the quality improvement process, with the researchers facilitating rather than dictating implementation efforts. Using EBQI methods, researchers and local staff adapt evidence-based practices for local resources, needs and preferences while maintaining fidelity to the evidence-base. PDSA cycles are used to continuously revise the adapted evidence-based practice based on feedback during pilot tests.
12035936|NCT00317005|Drug|folate treatment|
12035937|NCT00316992|Drug|Ramelteon and Placebo|Ramelteon 8 mg, tablets, orally, one night only and Ramelteon placebo-matching tablets, orally, one night only.
12035938|NCT00316979|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|
12035939|NCT00316966|Behavioral|Multidisciplinary dietary intervention|
12035940|NCT00316953|Drug|dasatinib|Given orally
12035941|NCT00316953|Other|pharmacological study|Correlative studies
12035942|NCT00316953|Other|laboratory biomarker analysis|Correlative studies
12035943|NCT00316940|Drug|bortezomib|
12035944|NCT00316940|Radiation|samarium Sm 153 lexidronam pentasodium|
12035945|NCT00316927|Drug|acetylsalicylic acid|
12035946|NCT00316927|Drug|dexamethasone|
12035947|NCT00316927|Drug|diethylstilbestrol|
12035948|NCT00316914|Drug|calcium gluconate|Given IV
12035949|NCT00316914|Drug|magnesium sulfate|Given IV
12035950|NCT00316914|Other|placebo|Given IV
12035951|NCT00316901|Procedure|computed tomography|
12035952|NCT00316901|Procedure|positron emission tomography|
12035953|NCT00316901|Radiation|fludeoxyglucose F 18|
12035954|NCT00316888|Biological|cetuximab|Given IV
12035955|NCT00316888|Drug|cisplatin|Given IV
12035956|NCT00316888|Drug|fluorouracil|Given IV
12035957|NCT00316888|Radiation|radiotherapy|Given once daily 5 days a week for 5 weeks
12035958|NCT00316875|Drug|lapatinib ditosylate|1500 mg orally daily for as long as patients remain on trial (up to 8 cycles).
12035959|NCT00316875|Drug|Doxil|Administered intravenously (IV) every 4 weeks in a dose-escalating fashion according to a set schedule
12035960|NCT00316862|Drug|cisplatin|Given IV
12035961|NCT00316862|Drug|irinotecan hydrochloride|Given IV
12035962|NCT00316862|Procedure|therapeutic conventional surgery|Undergo Surgery
12035963|NCT00316862|Radiation|radiation therapy|Undergo radiation
12035964|NCT00316849|Other|pharmacological study|
12035965|NCT00316849|Procedure|adjuvant therapy|
12035966|NCT00316849|Radiation|3-dimensional conformal radiation therapy|
12035967|NCT00316849|Radiation|intensity-modulated radiation therapy|
12035968|NCT00316849|Drug|temsirolimus|Given IV
12035969|NCT00316849|Drug|temozolomide|Given orally
12035970|NCT00316836|Procedure|mammography|
12035971|NCT00316823|Genetic|gene expression analysis|
12035972|NCT00316823|Genetic|polymerase chain reaction|
12035973|NCT00316823|Genetic|reverse transcriptase-polymerase chain reaction|
12035974|NCT00316823|Other|diagnostic laboratory biomarker analysis|
12035975|NCT00316823|Other|immunohistochemistry staining method|
12035976|NCT00316823|Procedure|needle biopsy|
12035977|NCT00316810|Drug|Alemtuzumab|Day 0: Campath 30 mg i.v. infusion over 3-6 hours
12035978|NCT00316810|Drug|Rabbit Anti-Human Thymocyte Globulin|Day O: Single shot of a polyclonal antilymphocyte preparation (ATG-Fresenius - 8 mg/kg, or IMTIX-Sangstat ATG 4 mg/kg/day).
12035979|NCT00316797|Drug|123-I INER|Serial whole body planar imaging in the anterior and posterior projection will be performed at 1 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, and 18-24h following injection of 5 mCi of 123-I INER. Venous blood data will be acquired at each imaging time point. In addition a 24 hour urine collection will commence following radiotracer injection and urine sampled in five collections every 4 hours collection for first sixteen hours (4 collections), then one collection from 16 to 24 h. Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs using the MIRD method as described previously (Seibyl, et al, 1993). Plasma and urine metabolites will be characterized and safety assessments obtained.
12035980|NCT00316784|Drug|IDEA-033 (and rescue medication)|
12035981|NCT00316771|Drug|P38 Inhibitor (4) 150mg|150mg po qd
12035982|NCT00316771|Drug|P38 Inhibitor (4) 25mg|25mg po bid
12035983|NCT00316771|Drug|P38 Inhibitor (4) 300mg|300mg po qd
12035984|NCT00316771|Drug|P38 Inhibitor (4) 50mg|50mg po qd
12035985|NCT00316771|Drug|P38 Inhibitor (4) 75mg|75mg po bid
12035986|NCT00316771|Drug|Placebo|po bid
12035987|NCT00316758|Drug|GK Activator (2)|Escalating doses bid
12035988|NCT00316758|Drug|Metformin|As prescribed, in patients who were in study BM18249
12035989|NCT00316745|Drug|Campto, Topotesin|100 mg/m2, IV (in the vein) on day 1,15 of each cycle.
12035990|NCT00316745|Drug|TS-1|S-1 Day1~14, everyday P.O.(Day 15~28 rest)
12035991|NCT00316745|Drug|L-Plat|Oxaliplatin (85mg/m2) Day 1, 15
12035992|NCT00316745|Drug|Isovorin|l-leucovorin (200mg/m2) Day 1, 15
12035993|NCT00316745|Drug|5-FU|400 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle. 2400 mg/m2, CIV (in the vein) on day 1~3 (48 hours) of each 28 day cycle.
12035994|NCT00316732|Procedure|IPSS Questionnaire|
12035995|NCT00316732|Procedure|EQ-5D Questionnaire|
12035996|NCT00316719|Drug|LAM group|Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
12035997|NCT00316719|Drug|ADV group|Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
12035998|NCT00316706|Biological|GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)|Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule
12035999|NCT00316706|Biological|Havrix™|Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
12036000|NCT00316693|Biological|HPV-16/18 vaccine (Cervarix™)|Intramuscular injection, 3 doses
12036008|NCT00316589|Biological|IMVAMUNE (MVA-BN)|2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
12036009|NCT00316576|Procedure|Blood sampling for PCR|
12036010|NCT00316563|Drug|Marinol (Dronabinol)|Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.
12036011|NCT00316563|Other|Placebo|
12036012|NCT00316550|Drug|AV608|
12036013|NCT00316537|Drug|ATG002 (study drug)|
12036014|NCT00316524|Biological|MVA-BN® (IMVAMUNE)|1x 10E8_TCID50
12036015|NCT00316524|Biological|Placebo|Tris-Buffer
12036016|NCT00316511|Drug|Aroplatin|
12036017|NCT00316498|Drug|OGT918|
12036018|NCT00316472|Drug|Niacinamide|
12036019|NCT00316459|Drug|ERB-041|
12036020|NCT00316433|Drug|Irinotecan (CPT-11)|
12036021|NCT00316433|Drug|Oxaliplatin (Eloxatin)|
12036022|NCT00316420|Drug|Capecitabine (Xeloda)|650 mg/m2 po bid Days 1-14 750 mg/m2 po bid Days 1-14 850 mg/m2 po bid Days 1-14 950 mg/m2 po bid Days 1-14
12036023|NCT00316420|Drug|Gemcitabine|750 mg/m2 IV Days 1 & 8 q 21 days
12036024|NCT00316407|Drug|lapatinib (GW572016)|1000 mg po qd
12036025|NCT00316407|Drug|Carboplatin|AUC 2 weekly x 3 of 4 week cycle
12036026|NCT00316407|Drug|Paclitaxel|60 mg/m2 weekly x 3 of 4 week cycle
12036027|NCT00316394|Device|Preventive Care Checklist Form|
12036028|NCT00316381|Procedure|Autologous bone marrow-derived stem cells|
12036029|NCT00316368|Device|Ethicon TPW32 60 cm (pacing wires x 2)|
12036030|NCT00316355|Behavioral|Traditional CBT|CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
12036031|NCT00316355|Behavioral|Stepped-Care CBT|In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).
12036032|NCT00316342|Device|Back supports|
12036033|NCT00316329|Drug|Artesunate + Amodiaquine|
12036034|NCT00316316|Behavioral|Motivational interviewing plus exposure and response prevention (MI plus EX/RP)|Participants will receive 18 sessions of MI plus EX/RP.
12036035|NCT00316316|Behavioral|Exposure and response prevention (EX/RP)|Participants will receive 18 sessions of EX/RP.
12036036|NCT00316303|Drug|Twinrix|This vaccine will be given in three parts: at entry and after 3 and 6 months.
12036037|NCT00316303|Behavioral|Enhanced treatment as usual|Participants will receive comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
12036038|NCT00316290|Behavioral|Integrated Parent Training|Treatment will include behavioral parent training, a course on coping with depression, and cognitive-behavioral therapy targeted at coping with stressful parenting situations. Treatment will include weekly 2-hour sessions for 14 weeks.
12036039|NCT00316290|Behavioral|Behavioral Parent Training|Parents will receive behavioral training. Treatment will include weekly 2-hour sessions for 14 weeks.
12036040|NCT00316277|Behavioral|Standard Medical Management (SMM) of Prescription Opiate Abuse|Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.
12036041|NCT00316277|Behavioral|Enhanced Medical Management (EMM) of Prescription Opiate Abuse|Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.
12036042|NCT00316264|Biological|Motavizumab, palivizumab|Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
12036043|NCT00316264|Biological|Palivizumab, motavizumab|Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.
12036044|NCT00316264|Biological|Motavizumab|Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
12036045|NCT00316251|Device|Vibration Plate Therapy|
12036046|NCT00316238|Drug|olanzapine-RAIM|
12036047|NCT00316238|Drug|placebo|
12036048|NCT00316225|Drug|pemetrexed|500 milligrams per meter squared (mg/m^2) IV every 21 days for 6 cycles
12036049|NCT00316212|Drug|INS50589 Intravenous Infusion|
12036050|NCT00316199|Drug|gemcitabine|1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression
12036051|NCT00316199|Drug|paclitaxel|175 mg/m2, intravenous (IV), every 21 days until disease progression
12036052|NCT00316186|Drug|topotecan|Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.
12036053|NCT00316186|Drug|carboplatin|Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.
12036054|NCT00316173|Drug|topotecan|HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1
12036055|NCT00316173|Drug|CARBOPLATIN|HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1
12036056|NCT00316160|Drug|Bupropion Hydrochloride Extended-release|
12036057|NCT00316160|Drug|Extended-release Venlafaxine|
12036058|NCT00316147|Biological|DTPa-HBV-IPV/Hib vaccine|
12036059|NCT00316134|Procedure|Procedure/Surgery|Diagnostic and/or therapeutic procedure to remove pleural fluid.
12036060|NCT00316121|Device|HEALOS and Leopard Cage|Placement in interbody space
12036061|NCT00316121|Device|Leopard Cage and Autograft|Placement in the interbody space
12036062|NCT00316108|Device|WALLSTENT® Endoprosthesis™|Carotid Artery Stent
12036063|NCT00316095|Drug|telmisartan|
12036064|NCT00316095|Drug|simvastatin|
12036065|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
12036066|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
12036067|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
12036068|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
12036069|NCT00316082|Drug|Placebo|Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
12036070|NCT00316082|Drug|metformin|Tablets, Oral, 500-2000 mg, as needed (12 months LT)
12036071|NCT00316043|Behavioral|Written information for parents|
12036072|NCT00316043|Behavioral|Distance learning package for General Practitioners|
12036073|NCT00316043|Behavioral|Distance learning package for practice assistants|
12036074|NCT00316030|Drug|Bexarotene|
12036075|NCT00316017|Drug|7.5% hypertonic saline/6% Dextran-70 (HSD)|250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.
12036076|NCT00316017|Drug|7.5% hypertonic saline (HS)|250 cc dose given as a one-time IV bolus in the pre-hospital setting.
12036077|NCT00316017|Drug|0.9% normal saline|250 cc dose given as a one-time IV bolus in the pre-hospital setting.
12036078|NCT00316004|Drug|7.5% Hypertonic Saline in 6% Dextran-70 (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
12036079|NCT00316004|Drug|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
12036080|NCT00316004|Drug|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
12036081|NCT00315991|Behavioral|Blood Glucose Awareness Training for Parents|
12036082|NCT00315978|Device|Heart-to-Heart Decision Aid|
12036083|NCT00315965|Drug|Nitric oxide, Carbon monoxide, Helium|
12036084|NCT00315952|Drug|Exubera|
12036085|NCT00315939|Device|Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)|Integrated Biobehavioral Monitoring & Feedback-1 (IBMF-1): a hand-held computer (HHC) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia (Low BG Index), and glucose variability (Average Daily Risk Range) using previously published algorithms. The subjects were asked to carry the HHC and enter all their self-monitored blood glucose (SMBG) readings. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. Detailed instructions were provided on the meaning of these different types of glucose feedback; the study staff was available to answer any questions.
12036086|NCT00315939|Device|Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)|Integrated Biobehavioral Monitoring & Feedback-2 (IMBF-2) retains IMBF-1, but the HHC asked subjects to provide symptom ratings when blood glucose (BG) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. The patient manual for the HHC program is provided in supplementary data of published manuscript.
12036087|NCT00315926|Drug|Melatonin|Melatonin 50 mg during surgery and 10 mg every night for 3 nights
12036088|NCT00315926|Drug|Placebo|a mixture of ethanol and physiological saline
12036089|NCT00315913|Drug|Propranolol|IV Propranolol 1mg/min for a total of 2 minutes. Total dose 2mg
12036090|NCT00315913|Other|IV Placebo|IV Saline Solution
12036091|NCT00315900|Drug|Depakote ER|depakote ER
12036092|NCT00315900|Drug|Seroquel|seroquel
12036093|NCT00315887|Drug|Buprenorphine transdermal delivery system|
12036094|NCT00315874|Drug|Buprenorphine transdermal delivery system|
12036095|NCT00315861|Drug|pemetrexed|
12036096|NCT00315861|Drug|topotecan|
12036097|NCT00315848|Drug|Buprenorphine transdermal delivery system|
12036098|NCT00315835|Drug|Buprenorphine transdermal delivery system|
12036099|NCT00315822|Other|80% oxygen|Supplemental oxygen will be administered during surgery
12036100|NCT00315822|Other|30% oxygen|Subjects undergoing surgery will receive routine administration of oxygen
12036101|NCT00315796|Device|Biophilic Nature Scene and Sound|
12036102|NCT00315770|Procedure|weight loss diets for young adults|
12036103|NCT00315757|Biological|Mapatumumab|10 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
12036104|NCT00315757|Biological|Mapatumumab|20 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
12036105|NCT00315757|Drug|Bortezomib|1.3 mg/m^2 IV (in the vein), twice weekly for two weeks (Days 1, 4, 8, and 11) of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
12036106|NCT00315744|Drug|Salmeterol/fluticasone|Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.
12036107|NCT00315744|Drug|Fluticasone propionate|Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
12036108|NCT00315744|Drug|Salbutamol|Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
12036109|NCT00315731|Biological|Follicular Lymphoma|For subjects with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's
12036111|NCT00315705|Drug|clofarabine|Clofarabine 20-40 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle as the first of the three IV interventions administered. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
12036112|NCT00315705|Drug|Etoposide|Etoposide 75-100 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle following clofarabine therapy. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
12036113|NCT00315705|Drug|Cyclophosphamide|Cyclophosphamide 340-440 mg/m²/day as 30-60 minute intravenous (IV) infusion daily for 5 days of a 28 day cycle following the other two interventions. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
12036114|NCT00315692|Device|Biomarker Assay (CA125 and HE4)|
12036115|NCT00315679|Drug|Pentoxifylline (also known as oxpentifylline)|
12036116|NCT00315666|Drug|memantine|
12036117|NCT00315640|Drug|Anecortave Acetate Sterile Suspension, 6 mg/mL|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
12036118|NCT00315640|Drug|Anecortave Acetate Suspension Depot, 30 mg/mL|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
12036119|NCT00315640|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
12036120|NCT00315640|Other|Anecortave Acetate Vehicle|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
12036121|NCT00315627|Drug|Islet transplantation|Islet transplantation
12036122|NCT00315614|Biological|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes.
12036123|NCT00315601|Drug|Telithromycin|800 mg once a day for 5 days
12036124|NCT00315601|Drug|azithromycin|500 mg on day 1, and then 250 mg once-daily on days 2 through 5
12036125|NCT00315601|Procedure|bronchoalveolar lavage|One bronchoscopy with bronchoalveolar lavage with each drug administration
12036126|NCT00315601|Drug|Telithromycin|Telithromycin 800 mg once a day
12036127|NCT00315588|Drug|Islet Transplantation|Islet Transplantation in subjects with a previous kidney transplant.
12036128|NCT00315575|Procedure|BOLD and Perfusion brain MRI|Blood oxygenation and perfusion functional MRI performed twice, two weeks apart; each scan lasts 1 hour
12036129|NCT00315562|Procedure|carotid endarterectomy|
12036130|NCT00315549|Drug|Telithromycin|
12036131|NCT00315549|Drug|Penicillin|
12036132|NCT00315536|Drug|Administration of remifentanil and glycopyrrolate|2 mg, intravenius use
12036133|NCT00315523|Drug|Levocetirizine|
12036134|NCT00315510|Drug|Rosuvastatin|
12036135|NCT00315484|Drug|Epoetin alfa and Darbepoetin alfa|
12036136|NCT00315458|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch applied for 7-day wear.
12036137|NCT00315458|Drug|Placebo transdermal patch|Placebo to match buprenorphine transdermal patch 10 or 20.
12036138|NCT00315445|Drug|Buprenorphine transdermal patch|Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
12036139|NCT00315445|Drug|Placebo oxycodone/acetaminophen tablets|Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
12036140|NCT00315445|Drug|OXY/APAP|5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
12036141|NCT00315445|Drug|Placebo transdermal patch (TDS)|Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
12036142|NCT00315432|Drug|Pegylated Interferon and Ribavirin|
12036143|NCT00315367|Drug|Donepezil HCI (drug)|
12036144|NCT00315354|Other|Low glycemic index diet|Feeding protocol, all foods prepared in a metabolic kitchen
12036145|NCT00315354|Other|Low fat diet|Feeding protocol, all foods prepared in a metabolic kitchen
12036146|NCT00315354|Other|Very low carbohydrate diet|Feeding protocol, all foods prepared in a metabolic kitchen
12036147|NCT00315341|Drug|Buprenorphine/naloxone|Participants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need.
12036148|NCT00315341|Drug|Methadone|Participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit.
12036149|NCT00315328|Drug|Atropine|Atropine 1% each weekend day in the sound eye
12036150|NCT00315328|Device|Patching|Patching 2 hours per day
12036151|NCT00315328|Procedure|Near activities|near visual activities for at least one hour per day
12036152|NCT00315315|Procedure|Nasolacrimal balloon catheter dilation|Balloon catheter nasolacrimal duct dilation consists of punctal dilation of at least one punctum and the passage into the nose of a semi-flexible wire probe with an inflatable balloon on the tip.
12036153|NCT00315315|Procedure|Nasolacrimal intubation|Nasolacrimal duct intubation consists of punctal dilation of at least one punctum with the passage of a flexible lacrimal probe into the nose and the placement of a temporary stent in the nasolacrimal duct.
12036154|NCT00315315|Procedure|Nasolacrimal duct probing|Simple nasolacrimal duct probing consists of punctal dilation of at least one punctum and the passage of a probe into the nose.
12036155|NCT00315302|Drug|Atropine|Atropine 1% once each weekend day
12036156|NCT00315302|Device|Plano Lens|Plano lens for the sound eye
12036157|NCT00315289|Procedure|Nasolacrimal balloon catheter duct dilation|
12036158|NCT00315289|Procedure|Nasolacrimal intubation|
12036159|NCT00315289|Procedure|Simple Nasolacrimal duct probing|
12036160|NCT00315276|Drug|Modafinil|
12036225|NCT00314704|Drug|dopamine versus norepinephrine|
12036226|NCT00314691|Genetic|Blood samples|
12036227|NCT00314678|Drug|Topotecan|
12036228|NCT00314678|Drug|Cisplatin|
12036229|NCT00314678|Drug|Paclitaxel|
12036230|NCT00314665|Drug|Thalidomide|
12036231|NCT00314652|Drug|Buprenorphine transdermal delivery system|
12036862|NCT00309881|Drug|doxorubicin hydrochloride|
12036161|NCT00315250|Drug|[123I]β-CIT|"Single Photon Emission Computed Tomography
~SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI."
12036162|NCT00315237|Drug|vinflunine and best supportive care|solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
12036163|NCT00315224|Behavioral|heart-rate controlled 12 week exercise program|
12036164|NCT00315211|Drug|Intravenous Topotecan|Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
12036165|NCT00315211|Drug|Intravenous Docetaxel|Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
12036166|NCT00315198|Device|Eye Patch|2 hours daily patching
12036167|NCT00315198|Procedure|Near activities|near visual activities while patching
12036168|NCT00315198|Procedure|Distance activities|distance visual activities while patching
12036169|NCT00315185|Drug|Cetuximab|
12036170|NCT00315172|Procedure|Non-Exercise Activity Thermogenesis (NEAT)|
12036171|NCT00315159|Procedure|Sentinel Node Biopsy|Inguinal sentinel node biopsy will be performed.
12036172|NCT00315146|Drug|Pioglitazone|
12036173|NCT00315146|Behavioral|Resistance exercise training to maximize muscle power|
12036174|NCT00315146|Behavioral|Hypocaloric diet|
12036175|NCT00315146|Drug|Placebo|
12036176|NCT00315133|Procedure|Immunosuppression and autologous stem cell transplantation|Immunosuppression and autologous stem cell transplantation: Mobilization of hematopoietic stem cells (HSC) with cyclophosphamide (2 g/m2) and granulocyte-colony stimulating factor (G-CSF, 10 ug/kg/d), followed by collection and cryopreservation of unselected HSC and conditioning with cyclophosphamide (200 mg/kg) plus rabbit anti-thymocyte globulin (ATG 4.5 mg/kg).
12036177|NCT00315120|Procedure|A. Active OMT and active UST|Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
12036178|NCT00315120|Procedure|B. Sham OMT and active UST|Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
12036179|NCT00315120|Procedure|C. Active OMT and sham UST|Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
12036180|NCT00315120|Procedure|D. Sham OMT and sham UST|Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
12036181|NCT00315107|Drug|Alesse|
12036182|NCT00315094|Behavioral|Caregiving support interventions (FamTechCare)|One set of combined interventions to be tested in this study are nursing interventions for the prevention of catheter-related infection, reactive depression, and HPN home care problem-solving. The other set of combined interventions are for increasing social support and use of a short nap to reduce daily fatigue. Information about all the interventions were incorporated into Internet formats as a booster for reinforcement.
12036183|NCT00315081|Drug|Bromocriptin|
12036184|NCT00315055|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, Intramuscular (IM)
12036185|NCT00315055|Biological|DTaP-IPV//PRP~T combined|0.5 mL, IM
12036186|NCT00315055|Biological|Hepatitis B vaccine|0.5 mL, IM
12036187|NCT00315042|Drug|Telithromycin (HMR3647)|
12036188|NCT00315042|Drug|Penicillin|
12036189|NCT00315029|Behavioral|evidence based decision aid|evidence based decision aid
12036190|NCT00315029|Behavioral|Possible reimbursement 4th IVF/ICSI cycle when necessary|Potential reimbursement 4th IVF/ICSI cycle when necessary
12036191|NCT00315016|Drug|eplerenone|active comparator
12036192|NCT00315016|Drug|fosinopril|doubling of fosinopril dose
12036193|NCT00315016|Drug|placebo|placebo (double dummy)
12036194|NCT00315003|Drug|Telithromycin|
12036195|NCT00315003|Drug|Azithromycin|
12036196|NCT00314990|Drug|5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin|
12036197|NCT00314977|Drug|Doxorubicin|doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
12036198|NCT00314977|Drug|Cyclophosphamide|Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
12036199|NCT00314977|Drug|Docetaxel|Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
12036200|NCT00314964|Drug|PD-0299685|
12036201|NCT00314951|Drug|Fidaxomicin|200 mg oral capsules two times daily (q12h regimen)
12036202|NCT00314951|Drug|Vancomycin|125 mg capsules q6hr (4 times a day)
12036203|NCT00314951|Drug|Matching Placebo to Fidaxomicin|Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
12036204|NCT00314938|Drug|PHA-794428|
12036205|NCT00314925|Drug|Seneca Valley Virus (biological agent)|Dose escalation (starting at 1 × 10^7 vp/kg), IV (in the vein) over 1 hour in a single administration
12036206|NCT00314912|Drug|Tramiprosate (3APS)|
12036207|NCT00314886|Drug|Diet|
12036208|NCT00314873|Drug|Gleevec (imatinib)|Imatinib 600mg po qd X 21 days.
12036209|NCT00314860|Drug|ropinirole Extended Release (XR)|
12036210|NCT00314847|Device|Extra-Corporeal Life Support -Impella 2.5|Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended)
12036211|NCT00314834|Drug|Intradialytic parenteral nutrition|
12036212|NCT00314821|Drug|ropinirole|
12036213|NCT00314808|Drug|Dronabinol|Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy
12036214|NCT00314795|Drug|Peginesatide|Peginesatide injection
12036215|NCT00314782|Drug|ZD4054 (Zibotentan)|oral tablet
12036216|NCT00314782|Drug|Docetaxel|intravenous infusion
12036217|NCT00314782|Drug|Placebo|
12036218|NCT00314756|Drug|imiquimod|
12036219|NCT00314743|Drug|Ondansetron|
12036220|NCT00314743|Drug|Dexamethasone|
12036221|NCT00314743|Drug|Aprepitant|
12036222|NCT00314730|Device|handheld Personal Digital Assistant (PDA)|
12036223|NCT00314717|Behavioral|Control diet|
12036224|NCT00314717|Behavioral|Low GI diet|
12036232|NCT00314639|Drug|modafinil|Modafinil OR Placebo 100mg orally (on the morning) from day 0 to day 14 and 200mg orally (on the morning) from day 15 to day 28. AND REVERSE : Modafinil OR Placebo 100mg orally (on the morning) from day 42 to day 56 and 200mg orally (on the morning) from day 57 to day 70.
12036233|NCT00314626|Drug|efavirenz|Efavirenz
12036234|NCT00314626|Drug|Abacavir+lamivudine|Abacavir+lamivudine
12036235|NCT00314613|Drug|Antipsychotic/Risperidone Consta|
12036236|NCT00314600|Device|above and below elbow cast|
12036237|NCT00314587|Procedure|1 or 2 elastic stable intramedullary nails|
12036238|NCT00314574|Drug|omalizumab (Xolair)|Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP.
12036239|NCT00314574|Drug|placebo|Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab.
12036240|NCT00314574|Drug|corticosteroids|Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day.
12036241|NCT00314574|Drug|long-acting beta-agonists|50 µg salmeterol twice daily or 12 µg formoterol twice daily.
12036242|NCT00314561|Drug|Pioglitazone, Rosiglitazone|
12036243|NCT00314548|Drug|PGE1 (prostacyclin)|alprostadil nebulization
12036244|NCT00314548|Drug|normal saline|nebulize for 30 mins
12036245|NCT00314509|Drug|Ciclesonide/Formoterol Combination|
12036246|NCT00314483|Drug|Mesenchymal Stem Cell Infusion|
12036247|NCT00314457|Drug|Bupivacaine|Patients receive either normal saline or Bupivacaine in normal saline that infuses intraarticularly for 48 hours.
12036248|NCT00314431|Procedure|Care coordination by telephone contacts with a nurse|
12036249|NCT00314418|Procedure|Colonoscopy in the prone position|
12036250|NCT00314405|Drug|Methylene blue (1%)|
12036251|NCT00314405|Drug|Rhenium sulfure|
12036252|NCT00314405|Procedure|Surgical procedure|
12036253|NCT00314405|Procedure|Anatomo-pathologic procedure|
12036254|NCT00314392|Behavioral|Information (behavior)|
12036255|NCT00314379|Drug|Vitamin E 400IU/day|
12036256|NCT00314366|Biological|Stem Cell Therapy|Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.
12036257|NCT00314366|Other|Control (plasma)|Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
12036258|NCT00314353|Drug|Bevacizumab|"7.5 mg/kg IV Day 1 every 21 days for eight cycles*
~*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression."
12036259|NCT00314353|Drug|Oxaliplatin|130 mg/m2 IV Day 1 every 21 days for eight cycles
12036260|NCT00314353|Drug|Capecitabine|"850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*#
~*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.
~#For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID"
12036261|NCT00314353|Drug|Irinotecan|200 mg/m2 IV Day 1 every 21 days for eight cycles
12036262|NCT00314340|Behavioral|Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity|The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects.
12036263|NCT00314340|Drug|ER Morphine|
12036264|NCT00314340|Drug|hydrocodone plus acetaminophen|
12036265|NCT00314340|Drug|placebo|
12036266|NCT00314327|Drug|long-acting injectable risperidone|One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
12036267|NCT00314314|Drug|Intranasal Insulin|Intranasal spray; 40 IU qid; 8 weeks
12036268|NCT00314314|Drug|Diluent|Intranasal spray; 8 weeks
12036269|NCT00314301|Device|loaded sit-to-stand training|
12036270|NCT00314288|Drug|Sarizotan HCl|
12036271|NCT00314275|Device|Coronary Artery Stenting|Drug eluting stent
12036272|NCT00314275|Device|Endeavor|Drug eluting stent
12036273|NCT00314262|Drug|Erlotinib & Celecoxib|"Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
~Celecoxib given 400 mg orally BID continuously for 6 months."
12036274|NCT00314249|Drug|Placebo|Placebo, oral administration, twice daily for 12 weeks
12036275|NCT00314249|Drug|Milnacipran 100mg|Milnacipran 100mg per day (50mg BID [twice a day])
12036276|NCT00314236|Device|BST-CarGel with Microfracture|Microfracture performed with BST-CarGel added to the treated defect
12036277|NCT00314236|Procedure|Microfracture without BST-CarGel|Microfracture performed without BST-CarGel added to the treated defect.
12036278|NCT00314210|Drug|Quetiapine SR|
12036279|NCT00314197|Behavioral|Telephone Linked Care - Behavior Change Counseling System|
12036280|NCT00314197|Behavioral|Telephone-linked behavioral counseling|
12036281|NCT00314184|Drug|quetiapine fumarate|
12036282|NCT00314171|Drug|Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension|One drop in the study eye(s) twice daily for 12 months
12036283|NCT00314171|Drug|Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)|One drop in the study eye(s) twice daily for 12 months
12036284|NCT00314158|Drug|Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension|One drop twice daily in each study eye for six months
12036285|NCT00314158|Drug|Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension|One drop twice daily in each study eye for six months
12036286|NCT00314158|Drug|Timolol 5 mg/ml eye drops, solution|One drop twice daily in each study eye for six months
12036287|NCT00314145|Biological|ChimeriVax™-JE|0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
12036288|NCT00314145|Biological|JE-VAX®|0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)
12036289|NCT00314132|Biological|ChimeriVax-JE, Japanese Encephalitis vaccine|0.5 mL, Subcutaneous
12036290|NCT00314132|Biological|0.9% Saline|0.5 mL, Subcutaneous
12036291|NCT00314106|Biological|Melanoma Reactive TIL|
12036292|NCT00314106|Drug|Cyclophosphamide|60 mg/kg/ day x 2 days intravenous
12036293|NCT00314106|Biological|IL-2|720,000 IU/kg/dose every 8 hours for up to 15 doses
12036294|NCT00314106|Drug|Fludarabine|25 mg/m^2/day intravenous x 5 days
12036295|NCT00314106|Radiation|1200 total body irradiation (TBI)|1200 cGY total body radiation
12036296|NCT00314093|Drug|RFT5pdgA|
12036297|NCT00314080|Drug|Botulinum AntiToxin|
12036298|NCT00314080|Procedure|neuro-electrophysiologic study, repetitive nerve stimulation|
12036299|NCT00314080|Procedure|Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure|
12036300|NCT00314067|Procedure|Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care|
12036301|NCT00314067|Procedure|Physician training|
12036302|NCT00314067|Procedure|Practice team training|
12036303|NCT00314054|Drug|HCV-796|HCV-796 1000mg single dose
12036304|NCT00314041|Biological|Meningococcal C|
12036305|NCT00314041|Biological|DTP/Hib|
12036306|NCT00314028|Behavioral|Focus on the Future|Focus on the Future is an educational program designed to promote proper condom use.
12036307|NCT00314028|Other|Control standard of care treatment|Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.
12036308|NCT00314015|Procedure|Evaluation of the success rate of implants|Evaluation of the success rate of implants will be followed.
12036309|NCT00314015|Procedure|Questionnaires|Questionnaires will be used
12036310|NCT00314002|Device|Mechanical Thrombectomy|
12036311|NCT00313989|Procedure|Evaluation of the success rate of implants|Evaluation of the success rate of implants
12036312|NCT00313976|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|250 micrograms every other day, subcutaneously for 104 weeks
12036313|NCT00313976|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|2x250 micrograms every other day, subcutaneously for 104 weeks
12036314|NCT00313963|Drug|Magnesium Sulfate|Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
12036315|NCT00313963|Drug|Normal Saline|Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
12036316|NCT00313950|Biological|Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella|0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)
12036317|NCT00313950|Biological|Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine|0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
12036318|NCT00313950|Biological|Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella|0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)
12036319|NCT00313937|Drug|Insulin glargine|
12036320|NCT00313924|Drug|DETRUSITOL|
12036321|NCT00313911|Biological|DTaP-IPV-HB-PRP~T|0.5 mL, Intramuscular (IM)
12036322|NCT00313911|Biological|Tritanrix-HepB/Hib|0.5 mL, Intramuscular
12036323|NCT00313898|Drug|sildenafil (viagra)|
12036324|NCT00313885|Drug|eplivanserin (SR46349)|oral administration
12036325|NCT00313885|Drug|placebo|oral administration
12036326|NCT00313872|Drug|DP|D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr Pre & Post medication Dexamethasone 8mg PO D0 Night (X1) D1 immediately upon waking in the morning, 1 hour before infusion Taxotere, Night (X3) D0 NS 1500 mL IV overnight hydration D1 DNK2 1000 mL IV over 2 hours, pre & post hydration (if Mg <WNL, mix MgSO4 1 amp) 20% Mannitol 70 mL IV full dripping, 30 mins before cisplatin D2-D3 Dexamethasone 8 mg PO bid, D4-D5 Dexamethasone 4 mg PO bid every 3 weeks
12036327|NCT00313872|Drug|FOLFIRI|FOLFIRI regimen D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan
12036328|NCT00313859|Drug|simvastatin|
12036329|NCT00313846|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
12036330|NCT00313846|Drug|Placebo|Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
12036331|NCT00313833|Drug|Buprenorphine transdermal delivery system|
12036332|NCT00313820|Drug|Pregabalin|Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
12036333|NCT00313820|Drug|Placebo|Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
12036334|NCT00313807|Drug|Amino Acid|7% amino acid infusion
12036335|NCT00313807|Drug|Placebo|0.9% Saline Infusion
12036336|NCT00313794|Drug|CP-675,206|15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.
12036337|NCT00313781|Drug|CP-751,871|CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days).
12036863|NCT00309881|Drug|prednisone|
12036338|NCT00313781|Drug|docetaxel|Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
12036339|NCT00313781|Drug|prednisone|Prednisone is administered at a dose of 5 mg twice daily.
12036340|NCT00313781|Drug|docetaxel|Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
12036341|NCT00313781|Drug|prednisone|Prednisone is administered at a dose of 5 mg twice daily.
12036342|NCT00313768|Drug|paclitaxel + carboplatin + bevacizumab|paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
12036343|NCT00313768|Drug|carboplatin + paclitaxel + bevacizumab + PF-3512676|carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles
12036344|NCT00313755|Procedure|Narrow Band Imaging|
12036345|NCT00313742|Drug|insulin detemir|
12036346|NCT00313742|Drug|insulin glargine|
12036347|NCT00313742|Drug|insulin NPH|
12036348|NCT00313729|Drug|temozolomide|Chemotherapy
12036349|NCT00313716|Drug|recombinant human erythropoietin, rhEpo|The study design is 2x2 factorial with randomization to erythropoietin or placebo and to transfusion trigger 10 gm/dl or 7 g/dl. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (first 74 patients, Epo1 dosing regimen), and then the 24- and 48-hour doses were stopped for the remainder of the patients (remaining 126 patients, Epo2 dosing regimen).
12036350|NCT00313716|Other|placebo|an inactive substance
12036351|NCT00313690|Drug|Bortezomib, Docetaxel and Cisplatin|
12036352|NCT00313625|Drug|busulfan|
12036353|NCT00313625|Drug|melphalan|
12036354|NCT00313625|Drug|methotrexate|
12036355|NCT00313625|Drug|tacrolimus|
12036356|NCT00313625|Procedure|allogeneic hematopoietic stem cell transplantation|
12036357|NCT00313625|Procedure|peripheral blood stem cell transplantation|
12036358|NCT00313612|Drug|oxaliplatin|Given IV
12036359|NCT00313612|Drug|topotecan|Given IV
12036360|NCT00313599|Drug|lapatinib|
12036361|NCT00313599|Drug|paclitaxel|
12036362|NCT00313586|Drug|Azacitidine|Given SC
12036363|NCT00313586|Drug|Entinostat|Given PO
12036364|NCT00313586|Other|Laboratory Biomarker Analysis|Correlative studies
12036365|NCT00313573|Procedure|management of therapy complications|
12036366|NCT00313573|Procedure|pain therapy|
12036367|NCT00313573|Procedure|psychosocial assessment and care|
12036368|NCT00313573|Procedure|quality-of-life assessment|
12036369|NCT00313560|Drug|erlotinib hydrochloride|Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)
12036370|NCT00313547|Drug|Quinapril 40 mg|
12036371|NCT00313547|Drug|Quinapril 10 mg and amlodipine 5 mg|
12036372|NCT00313534|Drug|masoprocol|
12036373|NCT00313521|Drug|thiotepa|
12036374|NCT00313521|Procedure|adjuvant therapy|
12036375|NCT00313521|Radiation|radiation therapy|
12036376|NCT00313508|Biological|Autologous Dendritic Cells (DC)|Given intranodally
12036377|NCT00313508|Drug|Fludarabine|Fludarabine will be administered intravenously (IV) over 30 minutes, daily for 5 consecutive days.
12036378|NCT00313508|Biological|Autologous Lymphocyte Infusion (ALI)|Infusion
12036379|NCT00313482|Drug|Sargramostim|250 mcg/m2 SC days 2-15 of each cycle
12036380|NCT00313482|Drug|Docetaxel|75 mg/m2 IV over 1 hour on Day 1 of each cycle
12036381|NCT00313482|Drug|Prednisone|5 mg orally BID on Day 1 continuously
12036382|NCT00313456|Drug|Satraplatin|Satraplatin is an oral platinum analogue that has shown promising activity in multiple tumor settings. Satraplatin (40 to 80 mg/m2/day) will be administered orally on days 1 to 5 of a 21 day cycle.
12036383|NCT00313443|Procedure|Fat tissue needle aspiration|Small fat tissue sampling performed by needle aspiration.
12036384|NCT00313417|Dietary Supplement|Creatine monohydrate|Up to 10 grams
12036385|NCT00313417|Other|Placebo|Placebo will be given in the same way and appearance as the active treatment
12036386|NCT00313404|Biological|Safety tested norovirus inoculum|This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards
12036387|NCT00313391|Drug|Risperdal Consta|
12036388|NCT00313378|Drug|Hypothetica|
12036389|NCT00313365|Procedure|Surgical Lavage (Arthrotomy)|
12036390|NCT00313365|Procedure|Arthrocentesis (Serial needle aspiration)|
12036391|NCT00313339|Drug|Intra-coronary infusion|In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.
12036392|NCT00313326|Procedure|Adaptative Support Ventilation|Adaptive Support Ventilation (ASV) is a new protocol of weaning of the tracheal prosthesis after surgery which maintains a preset ventilation by an operator, and this whatever the activity of the patient
12036393|NCT00313313|Drug|Saxagliptin|Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
12036394|NCT00313313|Drug|Saxagliptin|Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
12036395|NCT00313313|Drug|Glyburide|Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
12036396|NCT00313313|Drug|Placebo|Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
12036397|NCT00313313|Drug|Glyburide|Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
12036398|NCT00313313|Drug|Metformin|Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
12036399|NCT00313300|Drug|Apixaban|Tablets, Oral, 2.5 mg, twice daily, 26 weeks
12036400|NCT00313300|Drug|Apixaban|Tablets, Oral, 10 mg, once daily, 26 weeks
12036401|NCT00313300|Drug|Placebo|Tablets, Oral, 0, twice daily, 26 weeks
12036402|NCT00313300|Drug|Apixaban|Tablets, Oral 10 mg, twice daily, 26 weeks
12036403|NCT00313287|Drug|clevudine|
12036404|NCT00313274|Drug|Clevudine|
12036405|NCT00313261|Drug|Clevudine|
12036406|NCT00313248|Drug|Sagopilone (ZK 219477)|All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
12036407|NCT00313248|Drug|Sagopilone (ZK 219477)|Patients will receive 22mg/m2 as intravenous infusion.
12036590|NCT00311753|Drug|Certoparin|Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
12036408|NCT00313235|Biological|DC Vaccine and Cyclophosphamide|"Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site).
~Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks.
~CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure."
12036409|NCT00313222|Drug|bosentan|
12036410|NCT00313209|Drug|Roflumilast|500 µg, once daily, oral administration in the morning
12036411|NCT00313209|Drug|Placebo|once daily
12036412|NCT00313196|Drug|bosentan|Oral Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, maintenance dose: 125 mg
12036413|NCT00313183|Drug|pramlintide acetate|single subcutaneous doses of 15mcg and 30mcg
12036414|NCT00313170|Drug|Fulvestrant|intramuscular injection 250 mg & 500 mg
12036415|NCT00313157|Drug|Metoprolol|
12036416|NCT00313157|Drug|Diltiazem|
12036417|NCT00313157|Drug|Verapamil|
12036418|NCT00313157|Drug|Carvedilol|
12036419|NCT00313144|Drug|ARALAST Alpha1-Proteinase Inhibitor|Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician
12036420|NCT00313131|Drug|tinidazole+fluconazole vs metronidazole+clotrimazole|
12036421|NCT00313105|Drug|Smokeless tobacco (Oliver Twist pellets)|individual visits with counseling
12036422|NCT00313105|Behavioral|smoking cessation counseling|individual visits
12036423|NCT00313092|Device|nCPAP treatment|treatment with positive air pressure during night
12036424|NCT00313079|Drug|MAb 216|Dosage: 1.25mg/kg intravenous with dose escalation
12036425|NCT00313079|Drug|Vincristine|Dosage: 1.5mg/m2 intravenous weekly X 4
12036426|NCT00313053|Drug|Human mAb 216|Two treatment courses of mAb infusion will be given, with the same dose of antibody administered on Day 0 and on Day 7.
12036427|NCT00313053|Drug|Vincristine|Vincristine 1.5 mg/m2/dose (max dose = 2 mg) IVP on weekly x 4 doses (Days 7, 14, 21, 28)
12036428|NCT00313040|Behavioral|Brief Consultation with Health Counselor, workbook|
12036429|NCT00313040|Behavioral|Usual Care wait list|
12036430|NCT00313027|Radiation|PET scan|
12036431|NCT00313014|Drug|Buprenorphine|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
12036432|NCT00313014|Drug|Buprenorphine|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
12036433|NCT00313014|Drug|Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
12036434|NCT00313001|Drug|biphasic insulin aspart|
12036435|NCT00313001|Drug|exenatide|
12036436|NCT00312988|Drug|Hycamtin|
12036437|NCT00312988|Drug|Gemcitabine|
12036438|NCT00312975|Drug|CP-675,206|Given intravenously every 3 months
12036439|NCT00312975|Drug|best supportive care|As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
12036440|NCT00312962|Behavioral|Targeted cognitive training (TCT)|TCT includes cognitive remediation exercises that participants practice 1 hour per day, 5 days per week, for 20 weeks. TCT exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuo-spatial targets.
12036441|NCT00312962|Behavioral|Computer games|The control treatment involves commercially available computer games that participants practice 1 hour per day, 5 days per week, for 20 weeks.
12036442|NCT00312949|Behavioral|Interactive Website on management of schizophrenia|Participants in the web-user group will sit with a laptop computer, answer questions about themselves and their treatment, receive feedback on care that may be inconsistent with current recommendations, and receive suggestions on how to discuss this with their physicians.
12036443|NCT00312949|Behavioral|Written materials and video on management of schizophrenia|Participants in the written materials/video group will be given the reading material and will watch a 20-minute video.
12036444|NCT00312936|Behavioral|Mindfulness-based Stress Reduction (MBSR)|8 week program
12036445|NCT00312923|Drug|Policosanol|20 mg of policosanol in capsular form daily
12036446|NCT00312923|Dietary Supplement|Placebo|Two capsules of 10 mg of microcrystalline cellulose daily
12036447|NCT00312910|Drug|Probiotics-Bio-plus|
12036448|NCT00312897|Drug|Omega-3 Fatty Acids|10 wk treatment period
12036449|NCT00312897|Drug|corn oil|placebo comparator
12036450|NCT00312884|Device|HomMed Telemonitoring System|The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
12036451|NCT00312871|Drug|Epoetin alfa|
12036452|NCT00312858|Biological|Comparator: VAQTA™ (Hepatitis A vaccine)|VAQTA™ 0.5 mL injection
12036453|NCT00312858|Biological|Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)|ProQuad™ 0.5 mL injection
12036454|NCT00312858|Biological|Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)|Prevnar™ 0.5 mL injection
12036455|NCT00312845|Drug|Bortezomib + Rituximab|VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.
12036456|NCT00312845|Drug|Rituximab|rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).
12036457|NCT00312832|Drug|switching; dose reduction|
12036458|NCT00312819|Drug|chemotherapy +/- disulfiram|
12036459|NCT00312806|Drug|Pantoprazole|Pantoprazole 40 mg o.d.
12036460|NCT00312793|Device|stimulation of the quadriceps muscle with Myospare|
12036461|NCT00312780|Drug|XL784|XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
12036462|NCT00312767|Drug|Fabrazyme (agalsidase beta)|
12036463|NCT00312754|Drug|Atazanavir|
12036464|NCT00312741|Procedure|empirical versus microbiological guided treatment|
12036864|NCT00309881|Drug|vincristine sulfate|
12036465|NCT00312728|Drug|bevacizumab|15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be < 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity.
12036466|NCT00312728|Drug|First-Line Chemotherapy Agents|"Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily.
~All agents were dosed and administered per institutional standards using the respective package insert as a guideline."
12036467|NCT00312728|Drug|Second-Line Chemotherapy Agents|"Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued.
~All agents were dosed and administered per institutional standards using the respective package insert as a guideline."
12036468|NCT00312702|Biological|Falciparum Malaria Protein 11 with AS02A adjuvant|vaccine
12036469|NCT00312676|Procedure|Rapid versus slow conversion|
12036470|NCT00312663|Biological|Falciparum Malaria Protein 11 with AS01B adjuvant.|malaria experimental vaccine
12036471|NCT00312650|Drug|liposomal doxorubicin and gemcitabine|
12036472|NCT00312637|Procedure|Magnetic Resonance Spectroscopy|
12036473|NCT00312624|Procedure|contrast-enhanced cardiac MRI|MRI of heart with delayed enhancement
12036474|NCT00312611|Device|Transcend II Implantable Gastric Stimulator (IGS), Model 8848|
12036475|NCT00312598|Drug|Aripiprazole|
12036476|NCT00312585|Procedure|Acupuncture|
12036477|NCT00312585|Procedure|Sham comparator|
12036478|NCT00312572|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch applied for 7-day wear.
12036479|NCT00312559|Behavioral|Yoga Training|
12036480|NCT00312546|Drug|Enfuvirtide|90 mg subcutaneously twice daily
12036481|NCT00312546|Drug|Valproic acid|500 to 750 mg, taken orally twice daily
12036482|NCT00312533|Drug|Hylan F- 20|
12036483|NCT00312520|Drug|prednisolone|
12036484|NCT00312520|Drug|methylprednisolone|
12036485|NCT00312507|Drug|Bovine Lipid Extract Surfactant (administered by lavage)|
12036486|NCT00312507|Drug|Bovine Lipid Extract Surfactant (administered by bolus)|
12036487|NCT00312494|Drug|Placebo|Placebo with mood stabilizer (either lithium or divalproex)
12036488|NCT00312494|Drug|Ziprasidone|Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
12036489|NCT00312494|Drug|Ziprasidone|Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
12036490|NCT00312481|Drug|macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate|Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy
12036491|NCT00312481|Drug|NA picosulfate magnesium citrate|150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.
12036492|NCT00312455|Drug|Pro-eicosapentaenoic acid (EPA)|450 mg 5x/day
12036493|NCT00312455|Drug|Pro-docosapentaenoic acid (DPA)|100mg 5x/day
12036494|NCT00312455|Drug|Placebo|5 capsules/day
12036495|NCT00312442|Drug|Treatment with WST09 Vascular Photodynamic therapy|
12036496|NCT00312429|Procedure|Stem Cell Transplantation|Allogeneic umbilical cord blood stem cell transplant
12036497|NCT00312416|Drug|Clonidin|
12036498|NCT00312416|Drug|Brimonidine|
12036499|NCT00312403|Procedure|Blood Sample|A single venous blood sample will be taken (10 ml).
12036500|NCT00312390|Procedure|Flicker|
12036501|NCT00312390|Procedure|Retinal Vessel Diameter|
12036502|NCT00312390|Procedure|Retinal Blood Flow|
12036503|NCT00312377|Drug|Docetaxel|infusion
12036504|NCT00312377|Drug|Vandetanib|oral
12036505|NCT00312364|Drug|MRE0094|
12036506|NCT00312351|Drug|Pegaptanib sodium|
12036507|NCT00312338|Drug|VIGAMOX|1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
12036508|NCT00312325|Drug|Prednisolone|
12036509|NCT00312312|Biological|Specific immunotherapy|
12036510|NCT00312299|Device|Square edge PMMA IOL|Arm 1 A - Square edge PMMA IOL
12036511|NCT00312299|Device|Round edge PMMA IOL|Round edge PMMA IOL
12036512|NCT00312299|Device|Acrysof IOL|Acrysof IOL
12036513|NCT00312299|Device|square Edge PMMA IOL|Square edge PMMA intra ocular lens
12036514|NCT00312299|Device|Square Edge PMMA IOL|Square Edge PMMA IOL lens
12036515|NCT00312286|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12036516|NCT00312286|Drug|851B|851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
12036517|NCT00312286|Drug|851B|851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
12036518|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, once a week for 1 cycle.
12036519|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, once a week for 2 cycles.
12036520|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
12036521|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
12036522|NCT00312286|Drug|851B|851B placebo-matching gel, topically, once a week for 1 cycle.
12036523|NCT00312286|Drug|851B|851B placebo-matching gel, topically, twice a week for 1 cycle.
12036524|NCT00312286|Drug|851B|851B placebo-matching gel, topically, once a week for 2 cycles.
12036525|NCT00312286|Drug|851B|851B placebo-matching gel, topically, twice a week for 2 cycles.
12036526|NCT00312273|Drug|Aminophylline (250mg IV +/- a second dose of 250mg IV)|
12036591|NCT00311753|Drug|Heparin|7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days
12036592|NCT00311740|Drug|Valsartan|
12036593|NCT00311740|Drug|Hydrochlorothiazide|
12036865|NCT00309868|Drug|neseritide|
12036527|NCT00312260|Drug|Gabapentin|Gabapentin will be prescribed at 900mg/d (300mg tid). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.
12036528|NCT00312260|Drug|Amitriptyline|Amitriptyline will be prescribed at a dose of 10mg (qhs). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.
12036529|NCT00312234|Behavioral|Aerobic exercise|
12036530|NCT00312234|Behavioral|Qigong exercise|
12036531|NCT00312221|Drug|Buprenorphine|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
12036532|NCT00312221|Drug|Buprenorphine|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
12036533|NCT00312221|Drug|oxycodone immediate-release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
12036534|NCT00312208|Drug|docetaxel, doxorubicin, cyclophosphamide|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
12036535|NCT00312208|Drug|Docetaxel,doxorubicin, cyclophosphamide|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
12036536|NCT00312195|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
12036537|NCT00312195|Drug|Placebo to match BTDS|Placebo to match buprenorphine transdermal patch applied for 7-day wear.
12036538|NCT00312182|Drug|Nelfinavir|
12036539|NCT00312156|Drug|insulin detemir|
12036540|NCT00312156|Drug|insulin NPH|
12036541|NCT00312156|Drug|insulin aspart|
12036542|NCT00312143|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12036543|NCT00312130|Drug|Vildagliptin|
12036544|NCT00312117|Drug|Sodium bicarbonate|
12036545|NCT00312104|Drug|insulin detemir|
12036546|NCT00312104|Drug|insulin glargine|
12036547|NCT00312104|Drug|insulin aspart|
12036548|NCT00312091|Drug|Lamivudine, nevirapine, and stavudine fixed-dose tablet|7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
12036549|NCT00312091|Drug|Lamivudine|Dosage dependent on weight. More information on this criterion can be found in the protocol.
12036550|NCT00312091|Drug|Nevirapine|Dosage dependent on weight. More information on this criterion can be found in the protocol.
12036551|NCT00312091|Drug|Stavudine|Dosage dependent on weight. More information on this criterion can be found in the protocol.
12036552|NCT00312078|Dietary Supplement|Yogurt Supplementation|
12036553|NCT00312065|Device|Application of reflective heat shield to thermistor probe|
12036554|NCT00312052|Drug|E5555|50 mg or 100 mg E5555 tablets
12036555|NCT00312052|Drug|Placebo|50 mg and/or 100 mg placebo tablets
12036556|NCT00312039|Drug|elvucitabine|Elvucitabine 10 mg QD for 14days
12036557|NCT00312039|Drug|Lamivudine|Lamivudine 300 mg QD for 14 days
12036558|NCT00312026|Drug|efalizumab|
12036559|NCT00312013|Drug|Nadroparin|Patients will received all standard anti-cancer treatments. Therapeutic doses of nadroparin will be administered, subcutaneous for 2 weeks followed by half therapeutic doses for 4 weeks. After 4 weeks of wash-out, subsequent 2 week periods of therapeutic doses will be given for a total of 6 cycles each separated by a 4 week wash out. The study treatment period ends at week 46 regardless of the number of cycles achieved.
12036560|NCT00312000|Drug|capecitabine-irinotecan|"st line capecitabine 1250 mg/m2 orally b.i.d. on day 1-14
~nd line q 3 w irinotecan 350 mg/m2 IV infusion on day 1"
12036561|NCT00312000|Drug|capecitabine+irinotecan (1st line)|q 3 w irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 2 hours after discontinuation of the infusion followed by capecitabine 1000 mg/m2 orally b.i.d. on day 1-14
12036562|NCT00311987|Drug|3,5-Diiodothyropropionic acid (DITPA) therapy|
12036563|NCT00311974|Drug|Dihydralazine|
12036564|NCT00311961|Drug|Intravenous prednisolone|
12036565|NCT00311961|Drug|Oral prednisolone|
12036566|NCT00311948|Behavioral|Telephone counseling + interactive website = more abstinence|
12036567|NCT00311948|Behavioral|Behavioral: interactive website|
12036568|NCT00311935|Procedure|method of hernia repair|
12036569|NCT00311922|Behavioral|Literacy/Numeracy oriented educational intervention|Comprehensive educational Intervention
12036570|NCT00311922|Behavioral|Control Group|Receives comprehensive education that is not literacy/numeracy sensitive
12036571|NCT00311909|Device|Thalamic deep brain stimulation|
12036572|NCT00311896|Drug|Bemiparin|
12036573|NCT00311896|Drug|Placebo|
12036574|NCT00311883|Drug|hydroxychloroquine|
12036575|NCT00311870|Drug|nisoldipine|
12036576|NCT00311870|Drug|lisinopril|
12036577|NCT00311857|Drug|Cetuximab|
12036578|NCT00311857|Drug|Temozolomide|
12036579|NCT00311857|Procedure|Radiation therapy|
12036580|NCT00311844|Drug|desloratadine|
12036581|NCT00311831|Behavioral|Standard gastroenteritis education|Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
12036582|NCT00311831|Behavioral|Extensive gastroenteritis education|Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.
12036583|NCT00311818|Drug|Insulin glargine|
12036584|NCT00311805|Biological|Autologous Stem Cells (CD34+)|Intramuscular Injections
12036585|NCT00311792|Behavioral|LapSimGyn training until expert proficiency level is reached|Two consecutive simulations reaching predefined expert level
12036586|NCT00311792|Behavioral|Traditional clinical education|
12036587|NCT00311779|Drug|Spinosad Creme Rinse|
12036588|NCT00311766|Drug|Thymosin Beta 4|Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
12036589|NCT00311766|Drug|Placebo|Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days
12036594|NCT00311727|Biological|Influenza A/H5N1|232 subjects receive Influenza A/H5N1 vaccine as part of DMID protocols 04-063 and 04-076.
12036595|NCT00311714|Drug|CS-8958 formulated as dry powder|
12036596|NCT00311714|Other|Placebo|
12036597|NCT00311688|Drug|Interleukin-2|Biological response modifier in liquid form; dosage of drug will vary by study
12036598|NCT00311675|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in single-dose vials containing 90-mcg/mL A/H5N1 HA. Dosage is two 90 mcg doses administered intramuscularly separated by approximately 28 days.
12036599|NCT00311662|Drug|Tonabersat|Tablet 40mg daily for 12 weeks
12036600|NCT00311662|Drug|Placebo|Tablet once daily for 12 weeks
12036601|NCT00311649|Biological|Inactivated Influenza A Vaccine A/H5N1|
12036602|NCT00311636|Drug|cyclophosphamide|
12036603|NCT00311636|Drug|docetaxel|
12036604|NCT00311636|Drug|doxorubicin hydrochloride|
12036605|NCT00311636|Drug|epirubicin hydrochloride|
12036606|NCT00311636|Drug|fluorouracil|
12036607|NCT00311636|Drug|methotrexate|
12036608|NCT00311636|Drug|paclitaxel|
12036609|NCT00311636|Drug|triptorelin|
12036610|NCT00311636|Procedure|adjuvant therapy|
12036611|NCT00311623|Drug|Rapamycin 3mg|Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).
12036612|NCT00311623|Drug|Rapamycin 6mg|Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).
12036613|NCT00311623|Procedure|Radical prostatectomy|Radical prostatectomy performed on Day 15
12036614|NCT00311610|Drug|SN-38 liposome|38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression
12036615|NCT00311597|Procedure|Radiosurgery|single fractionated radiation therapy
12036616|NCT00311584|Drug|irinotecan hydrochloride|Given IV
12036617|NCT00311584|Drug|temozolomide|Given IV
12036618|NCT00311571|Drug|Ethidronate|
12036619|NCT00311571|Behavioral|Physical training|
12036620|NCT00311558|Biological|recombinant interferon alfa-2b|SSG x 5 week
12036621|NCT00311558|Drug|sodium stibogluconate|SSG & IFN
12036622|NCT00311558|Drug|SSG & interferon|1 arm study with SSG & interferon
12036623|NCT00311545|Biological|CNTO 328|Anti-IL-6 chimeric monoclonal antibody
12036624|NCT00311519|Drug|Hylenex|
12036625|NCT00311493|Biological|Tick-Borne Encephalitis vaccine|
12036626|NCT00311480|Biological|Influenza vaccine surface antigen adjuvanted with MF59|
12036627|NCT00311467|Drug|Capecitabine, Interferon, Interleukin|"Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.
~Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.
~Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.
~Group B
~Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
~Efficacy evaluations will be performed every 14 weeks of treatment in both groups"
12036628|NCT00311454|Drug|T.R.U.E.Test|
12036629|NCT00311441|Biological|Tick-Borne Encephalitis vaccine|
12036630|NCT00311428|Biological|Influenza|
12036631|NCT00311415|Biological|Meningococcal C conjugate vaccine|"Meningococcal conjugate vaccine, active comparator.
~Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age"
12036632|NCT00311402|Drug|Aggrenox capsule|extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily
12036633|NCT00311402|Other|Acetylsalicylic Acid (ASA)|Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily
12036634|NCT00311389|Drug|Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12036635|NCT00311389|Drug|Latanoprost 0.005%/Timolol 0.005% ophthalmic solution|Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12036636|NCT00311376|Biological|botulinum toxin Type A (200U)|botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
12036637|NCT00311376|Biological|botulinum toxin Type A (300U)|botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval
12036638|NCT00311376|Other|Normal Saline (Placebo); botulinum toxin Type A (200U)|Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
12036639|NCT00311376|Other|Normal Saline (Placebo); botulinum toxin Type A (300U)|Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval
12036640|NCT00311363|Drug|GEn (XP13512)|1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks
12036641|NCT00311363|Drug|GEn (XP13512)|1200 mg GEn (XP13512), orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks
12036642|NCT00311363|Drug|Placebo|Placebo, orally, once daily for 12 weeks following single blind 24-week phase
12036643|NCT00311350|Drug|MOA-728|
12036644|NCT00311337|Drug|bortezomib|
12036645|NCT00311324|Behavioral|Special Intervention|
12036646|NCT00311324|Behavioral|Delayed Intervention|
12036647|NCT00311311|Drug|tacrolimus|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
12036666|NCT00311129|Drug|Fludarabine Phosphate (Fludara)|Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
12036648|NCT00311311|Drug|mycophenolate mofetil|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
12036649|NCT00311311|Drug|prednisone|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
12036650|NCT00311311|Drug|sirolimus|"The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol.
~On study Day 1 Conversion, the daily dose of TAC will not be taken, and SRL is initiated as a single 5-10 mg loading dose, followed by 3 mg/day on subsequent days, adjusted to maintain a SRL target trough level of 8-15 ng/mL through to month 24 post-transplant, then 5-12 ng/mL to the end of month 36 post-transplant."
12036651|NCT00311311|Drug|tacrolimus|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. Reintroduction of TAC or introduction of CsA is not permitted in the SRL Therapy group.
12036652|NCT00311311|Drug|mycophenolate mofetil|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
12036653|NCT00311311|Drug|prednisone|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
12036654|NCT00311298|Dietary Supplement|Multimicronutrients|Randomised, double-blind trial among pulmonary TB patients, except those who are found to be sputum positive and HIV positive. Both arms received a daily biscuit weighing 30 g (4.5 g protein, 615 kJ). The biscuit given to the No micronutrient-arm contained no additional micronutrients. The biscuit given to the Micronutrient-arm contained the following micronutrients: vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg. The intervention was given for 60 days during initial TB treatment.
12036655|NCT00311298|Dietary Supplement|Energy and proteins|Randomised, single-blind trial among sputum-positive HIV-coinfected pulmonary TB patients. Both arms received a daily for biscuit weighing 30 g (4.5 g protein, 615 kJ), with micronutrients (vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg). The experimental arm received an additional 5 biscuits without additional micronutrients. Thus, both arms received the same amount of micronutrients. However, the intervention arm received 3690 kJ and 27 g protein per day, while the control arm received 615 kJ and 4.5 g protein. The intervention was given for 60 days during initial TB treatment.
12036656|NCT00311285|Device|Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry|
12036657|NCT00311272|Biological|MelCancerVac|
12036658|NCT00311259|Drug|Melatonin (drug)|
12036659|NCT00311259|Drug|Laktose|
12036660|NCT00311246|Drug|Adalimumab|Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.
12036661|NCT00311220|Drug|tuberculin for skin test|
12036662|NCT00311194|Behavioral|6 months readmission rate to hospital|
12036663|NCT00311181|Device|Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)|Patients that are indicated for an ICD or CRT-D receive one of these devices.
12036664|NCT00311168|Procedure|VIP On vs VIP Off|
12036665|NCT00311155|Drug|olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary|Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.
12036773|NCT00310284|Behavioral|Self-help manual to improve insomnia symptoms|
12036774|NCT00310271|Biological|pPJV7630 with pPJV2012 administered by PMED|
12036775|NCT00310258|Behavioral|Drug use prevention intervention|
12036667|NCT00311129|Drug|Rituximab|Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
12036668|NCT00311116|Drug|Vitamin E|
12036669|NCT00311103|Procedure|Specific clinical care program|The rheumatologists acted as principal care providers in regular visits, home visits and phone contacts. The visits were structured following specific proceedings for the different diagnoses based on previously demonstrated approaches. Such protocols included education and promotion of independence, pharmacological and no pharmacological treatment, and timing of diagnostic tests in a stepwise manner. The program also incorporated administrative duties such as the prescription of medication for the patients. Patients were seen as often as necessary according to the medical rheumatologist decision (until the episode of disability was medically resolved).
12036670|NCT00311090|Drug|Idrabiotaparinux sodium|"0.5 mL pre-filled syringe for 3.0 mg
~Subcutaneous injection"
12036671|NCT00311090|Drug|Idraparinux sodium|"0.5 mL pre-filled syringe for 2.5 mg
~Subcutaneous injection"
12036672|NCT00311090|Drug|Avidin|"100 mg in 10 mg/mL solution
~Intravenous infusion for 30 minutes"
12036673|NCT00311090|Drug|Placebo (for Avidin)|"Avidin matching powder in 10 mg/mL solution
~Intravenous infusion for 30 minutes"
12036674|NCT00311077|Drug|Insulin Glulisine|
12036675|NCT00311064|Behavioral|physical activity|
12036676|NCT00311051|Drug|ramatroban|
12036677|NCT00311051|Drug|montelukast|
12036678|NCT00311038|Drug|ONO-1101|
12036679|NCT00311025|Procedure|intensive endurance, strength and balance exercises|
12036680|NCT00311012|Drug|Aliskiren|
12036681|NCT00310999|Device|Shikani Optical Stylet|
12036682|NCT00310986|Behavioral|Breathing Meditation|
12036683|NCT00310973|Behavioral|Social Network Intervention|
12036684|NCT00310934|Drug|methadone|
12036685|NCT00310934|Drug|buprenorphine / methadone sequence|
12036686|NCT00310934|Behavioral|Relapse prevention|
12036687|NCT00310934|Behavioral|Contingency management|
12036688|NCT00310921|Drug|Misoprostol|
12036689|NCT00310908|Drug|Tramadol Hcl|Active Comparator
12036690|NCT00310895|Drug|Imetelstat Sodium (GRN163L)|Dose increase by 25% if tolerated infused over 2 hours
12036691|NCT00310869|Behavioral|Individualized Developmental Care in the NICU|Newborn Individualized Developmental Care and Assessment Program (NIDCAP) utilizes close observation of each infant's thresholds of moving from organization to disorganization and stress, as exhibited by the infant's behavior. Care and environment are then continuously and dynamically adjusted to increase the infant's self-regulation and organization and decrease the infant's stress. This individualized model of NICU care provides an opportunity to investigate the modifiability of very early born infants' brain function and structure and the possibility of reducing or altogether eliminating the disruption and disturbance of fetal brain development in the NICU.
12036692|NCT00310856|Biological|MenACWY-CRM|Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.
12036693|NCT00310856|Biological|MenC-CRM|One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.
12036694|NCT00310856|Biological|DTaP-Hib-IPV|
12036695|NCT00310856|Biological|PC7|One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
12036696|NCT00310856|Biological|MMR|
12036697|NCT00310856|Biological|Varicella|
12036698|NCT00310843|Drug|Nevirapine|Patients with HIV-1 infection who have taken or are currently taking nevirapine
12036699|NCT00310830|Drug|Bosentan|Oral, Initial dose: 62.5 mg b.i.d. for 4 weeks, maintenance dose: 125 mg b.i.d.
12036700|NCT00310817|Biological|MenACWY-CRM conjugate vaccine, adjuvanted|
12036701|NCT00310817|Biological|MenACWY polysaccharide vaccine|
12036702|NCT00310817|Biological|MenACWY-CRM conjugate vaccine, unadjuvanted|
12036703|NCT00310804|Biological|Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)|One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
12036704|NCT00310804|Biological|Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)|One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
12036705|NCT00310804|Biological|Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)|One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
12036706|NCT00310804|Biological|Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)|One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
12036707|NCT00310791|Drug|Hormone replacement therapy (estrogen/progestin)|Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)
12036708|NCT00310791|Other|Placebo (Sugar Pill)|Placebo (sugar pill)
12036709|NCT00310791|Drug|Dehydroepiandrosterone (DHEA)|50 mg tablet, 1 daily
12036710|NCT00310778|Drug|high sodium diet|high sodium diet
12036711|NCT00310778|Drug|low sodium diet|low sodium diet
12036712|NCT00310778|Drug|ramipril 10 mg|ramipril 10 mg
12036713|NCT00310778|Drug|valsartan 160 mg|valsartan 160 mg
12036714|NCT00310778|Drug|candesartan 8 mg|candesartan 8 mg
12036715|NCT00310778|Drug|atenolol 50 mg|atenolol 50 mg
12036716|NCT00310765|Drug|Pregabalin|First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days
12036717|NCT00310765|Drug|Pregabalin|75 mg po BID
12036718|NCT00310752|Device|DermaStream(tm) application and Streaming of Saline|
12036719|NCT00310726|Other|abrupt weaning at 4 months|abrupt weaning at 4 months
12036720|NCT00310726|Other|Continued exclusive breastfeeding|Continued exclusive breastfeeding
12036776|NCT00310245|Procedure|STI (structured Treatment Interruption)|
12036777|NCT00310232|Drug|Epoetin Alfa|
12036778|NCT00310219|Procedure|computed tomography|
12036721|NCT00310713|Biological|Meningococcal C conjugate vaccine|Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
12036722|NCT00310700|Biological|Meningococcal C conjugate vaccine|
12036723|NCT00310687|Procedure|BLOOD DRAW|
12036724|NCT00310674|Biological|Meningococcal C Conjugate Vaccine|
12036725|NCT00310661|Drug|Sarizotan|The dose of sariztan HCI for each patient in the drug arm will be given 2mg b.i.d. orally during the first 4 weeks of treatment. If efficacy is inadequate and there are no safety concerns, the option to raise the dose to 5mg b.i.d is given. After 8 weeks of treatment, the option to raise the dose to 7mg bid is given. Dose may remain the same or may be decreased again to the previous dose.
12036726|NCT00310661|Other|Placebo|Placebo for each patient randomized to the placebo arm will be given placebo (oral, twice daily) in a pill form for 12 weeks
12036727|NCT00310648|Biological|Influenza vaccine|
12036728|NCT00310635|Biological|Meningococcal C conjugate vaccine|
12036729|NCT00310622|Device|HyperQ Signal recording|
12036730|NCT00310609|Drug|Gadopentetate dimeglumine (Magnevist)|Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day
12036731|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|0,1mmol/kg at 10 mL/15 sec
12036732|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|same dose as arm 1 at bolus rate (2mL/sec)
12036733|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|0,3mmol/kg at 10 mL/15 sec
12036734|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|same dose as arm 3 at bolus rate (2mL/sec)
12036735|NCT00310596|Drug|Moxifloxacin (BAY12-8039)|400 mg at 0,07 mL/sec over 60 min
12036736|NCT00310596|Drug|Placebo|0,9% saline at 0,6mL/kg at bolus rate
12036737|NCT00310583|Drug|Pregabalin|
12036738|NCT00310570|Device|Circumferential thermoplastic thimble splint|
12036739|NCT00310570|Device|"dorsal aluminium foam Mexican Hat splint"|
12036740|NCT00310570|Device|stack splint (control)|
12036741|NCT00310557|Drug|Gadopentetate dimeglumine (Magnevist)|Approximately 0.1mmol/kg body weight, single intravenous administration on the study day
12036742|NCT00310544|Drug|Magnevist (Gadopentetate dimeglumine, BAY86-4882)|One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight
12036743|NCT00310544|Drug|Magnevist (Gadopentetate dimeglumine, BAY86-4882)|One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period 1: Magnevist 0.2 mmol/kg body weightperiod 2: Magnevist 0.1 mmol/kg body weight
12036744|NCT00310531|Drug|Menostar (Estradiol, BAY86-5435)|Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
12036745|NCT00310531|Drug|Raloxifene|Raloxifene tbl. (60 mg/day)
12036746|NCT00310518|Drug|ARQ 501|
12036747|NCT00310505|Drug|Amphotericin B deoxycholate given as daily administration|
12036748|NCT00310492|Biological|subcutaneous immunotherapy|Updosing by 16 injections to 100,000 SQ-U
12036749|NCT00310479|Device|Magnetic Resonance Spectroscopy (3Tesla)|
12036750|NCT00310466|Biological|Sublingual immunotherapy|once daily intake of sublingual drops
12036751|NCT00310466|Biological|Placebo|once daily intake of sublingual drops
12036752|NCT00310453|Biological|ALK Grass tablet|
12036753|NCT00310440|Device|P-15 Synthetic osteoconductive bone substitute|Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
12036754|NCT00310440|Other|Autologous bone|Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
12036755|NCT00310427|Drug|LY686017|50 mg administered orally on a daily basis
12036756|NCT00310427|Drug|Placebo|Administered on a daily basis
12036757|NCT00310401|Drug|Albuterol|5 mg nebulized q4h
12036758|NCT00310401|Drug|Saline|1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
12036759|NCT00310388|Drug|Retigabine (INN), Ezogabine (USAN)|Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
12036760|NCT00310375|Drug|Ezogabine: USAN Retigabine (International Nonproprietary Name)|Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.
12036761|NCT00310362|Behavioral|Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures|Interactive voice response system (IVR) calls patients 7 or 3 days prior to their appointment. Information available in the IVR system is based on the same template nurses use in usual care and includes an appointment reminder, preparation instructions, basic information about the procedure, and answers to commonly asked questions.
12036762|NCT00310349|Biological|23 valent pneumococcal polysaccharide vaccine|
12036763|NCT00310336|Drug|S-adenosyl-L-methionine|
12036764|NCT00310336|Drug|betaine|
12036765|NCT00310336|Drug|pegylated interferon alpha2b|
12036766|NCT00310336|Drug|ribavirin|
12036767|NCT00310323|Drug|Dextromethorphan|0.5 mg/kg (maximum 30 mg)
12036768|NCT00310323|Drug|Caffeine|Administered as 4 ounces of Coca-Cola
12036769|NCT00310310|Behavioral|Sleep Apnea Self-Management Program|Sleep apnea self-management program - 4 sessions, group-based.
12036770|NCT00310310|Behavioral|Usual care|Usual sleep apnea and cpap care
12036771|NCT00310297|Drug|Insulin Glulisine|
12036772|NCT00310284|Behavioral|Computerized delivery of cognitive-behavioral treatment of insomnia|
12036779|NCT00310219|Procedure|positron emission tomography|
12036780|NCT00310206|Biological|Inactivated Influenza A Vaccine A/H5N1|Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
12036781|NCT00310206|Biological|Inactivated Influenza A Vaccine A/H5N1|Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
12036782|NCT00310180|Drug|Anastrozole|Given PO
12036783|NCT00310180|Drug|Exemestane|Given PO
12036784|NCT00310180|Other|Laboratory Biomarker Analysis|Correlative studies
12036785|NCT00310180|Drug|Letrozole|Given PO
12036786|NCT00310180|Other|Quality-of-Life Assessment|Ancillary studies
12036787|NCT00310180|Radiation|Radiation Therapy|Undergo radiation therapy or partial breast irradiation
12036788|NCT00310180|Drug|Tamoxifen Citrate|Given PO
12036789|NCT00310167|Radiation|radiation therapy|
12036790|NCT00310154|Drug|docetaxel|
12036791|NCT00310154|Drug|gefitinib|
12036792|NCT00310154|Other|laboratory biomarker analysis|
12036793|NCT00310154|Radiation|radiation therapy|
12036794|NCT00310141|Behavioral|Smoking cessation intervention|6 weeks of computer delivered treatment for quitting smoking
12036795|NCT00310141|Other|Counseling intervention|In-person counseling (5 sessions)
12036796|NCT00310141|Drug|Nicotine patch|6-week supply of the nicotine patch
12036797|NCT00310128|Drug|cisplatin|
12036798|NCT00310128|Drug|cytarabine|
12036799|NCT00310128|Drug|etoposide|
12036800|NCT00310128|Drug|methylprednisolone|
12036801|NCT00310128|Drug|rituximab|
12036802|NCT00310128|Drug|yttrium Y 90 ibritumomab tiuxetan|
12036803|NCT00310128|Procedure|antibody therapy|
12036804|NCT00310128|Procedure|biological therapy|
12036805|NCT00310128|Procedure|chemotherapy|
12036806|NCT00310128|Procedure|monoclonal antibody therapy|
12036807|NCT00310128|Procedure|radiation therapy|
12036808|NCT00310128|Procedure|radioimmunotherapy|
12036809|NCT00310128|Procedure|radioisotope therapy|
12036810|NCT00310115|Behavioral|Smoking Prevention Usual Care|Usual care of self-help materials and advice for staying cigarette free
12036811|NCT00310115|Behavioral|Counseling Intervention|6 x 30 minute counseling sessions over the telephone
12036812|NCT00310115|Behavioral|Counseling Intervention|2 in-person counseling sessions
12036813|NCT00310089|Biological|filgrastim|
12036814|NCT00310089|Biological|pegfilgrastim|
12036815|NCT00310089|Drug|cediranib maleate|
12036816|NCT00310089|Drug|cyclophosphamide|
12036817|NCT00310089|Drug|docetaxel|
12036818|NCT00310089|Drug|doxorubicin hydrochloride|
12036819|NCT00310089|Other|laboratory biomarker analysis|
12036820|NCT00310089|Procedure|conventional surgery|
12036821|NCT00310089|Procedure|neoadjuvant therapy|
12036822|NCT00310076|Drug|thalidomide|Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
12036823|NCT00310076|Procedure|surgery|Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
12036824|NCT00310063|Procedure|acupressure therapy|Acupressure wristband
12036825|NCT00310063|Procedure|sham intervention|Sham wristband
12036826|NCT00310050|Drug|pemetrexed disodium|500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
12036827|NCT00310050|Device|Radiotherapy|During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
12036828|NCT00310037|Drug|bortezomib|Given IV
12036829|NCT00310024|Drug|bortezomib|Given IV
12036830|NCT00310024|Drug|vorinostat|Given orally
12036831|NCT00310024|Other|laboratory biomarker analysis|Correlative studies
12036832|NCT00310024|Other|pharmacological study|Correlative studies
12036833|NCT00310011|Drug|cisplatin|
12036834|NCT00310011|Drug|gemcitabine hydrochloride|
12036835|NCT00310011|Drug|paclitaxel|
12036836|NCT00310011|Procedure|conventional surgery|
12036837|NCT00309998|Biological|bevacizumab|
12036838|NCT00309998|Drug|vinorelbine tartrate|
12036839|NCT00309985|Drug|androgen-deprivation therapy|LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.
12036840|NCT00309985|Drug|docetaxel|Given IV
12036841|NCT00309972|Drug|Control arm (SEQ):|Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).
12036842|NCT00309972|Drug|Experimental arm (CON):|concurrent chemo-radiotherapy [55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20] followed by two cycles of cisplatinum/vinorelbine.
12036843|NCT00309959|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
12036844|NCT00309959|Other|Laboratory Biomarker Analysis|Correlative studies
12036845|NCT00309946|Drug|cediranib maleate|Given orally
12036846|NCT00309933|Procedure|cognitive assessment|
12036847|NCT00309933|Procedure|psychosocial assessment and care|
12036848|NCT00309933|Procedure|quality-of-life assessment|
12036849|NCT00309920|Biological|darbepoetin alfa|
12036850|NCT00309920|Drug|cyclophosphamide|
12036851|NCT00309920|Drug|docetaxel|
12036852|NCT00309920|Drug|doxorubicin hydrochloride|
12036853|NCT00309920|Drug|epirubicin hydrochloride|
12036854|NCT00309920|Drug|fluorouracil|
12036855|NCT00309907|Biological|etanercept|Given IV and subcutaneously
12036856|NCT00309907|Drug|methylprednisolone|Given IV and orally
12036857|NCT00309894|Biological|sargramostim|
12036858|NCT00309894|Drug|ketoconazole|
12036859|NCT00309894|Drug|therapeutic hydrocortisone|
12036860|NCT00309881|Biological|rituximab|
12036861|NCT00309881|Drug|cyclophosphamide|
12036866|NCT00309855|Drug|Placebo|im and orally
12036867|NCT00309855|Drug|Testosterone|injections
12036868|NCT00309855|Drug|Anastrazole|orally x 21 days
12036869|NCT00309855|Drug|Dutasteride|orally x 21 days
12036870|NCT00309842|Biological|filgrastim|All patients will receive G-CSF 5 mcg/kg/day intravenously(IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days.
12036871|NCT00309842|Drug|cyclophosphamide|Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW > 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight.
12036872|NCT00309842|Drug|cyclosporine|Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of > 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.
12036873|NCT00309842|Drug|fludarabine phosphate|Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6);
12036874|NCT00309842|Drug|mycophenolate mofetil|"All patients will begin mycophenolate mofetil (MMF) on day -3. Patients ≥ 40 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours).
~Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg three times a day."
12036875|NCT00309842|Procedure|umbilical cord blood transplantation|The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.
12036876|NCT00309842|Radiation|total-body irradiation|The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1).
12036877|NCT00309816|Drug|sildenafil|
12036878|NCT00309803|Device|FiberNet Embolic Protection Device|
12036879|NCT00309790|Drug|sildenafil|
12036880|NCT00309777|Drug|Pitavastatin|Pitavastatin once daily
12036881|NCT00309777|Drug|Simvastatin|Simvastatin once daily
12036882|NCT00309764|Behavioral|Telemedicine|
12036883|NCT00309751|Drug|Pitavastatin|Pitavastatin 4 mg QD
12036884|NCT00309751|Drug|Atorvastatin|Atorvastatin 20 mg
12036885|NCT00309738|Drug|pitavastatin|
12036886|NCT00309738|Drug|simvastatin|
12036887|NCT00309725|Drug|galantamine|
12036888|NCT00309712|Drug|fenofibrate 160 mg and placebo|
12036889|NCT00309712|Drug|simvastatin 20 mg and placebo|
12036890|NCT00309712|Drug|fenofibrate 160 mg and simvastatin 20 mg|
12036891|NCT00309699|Drug|Placebo|Daily for 3 weeks
12036892|NCT00309699|Drug|Quetiapine|400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks
12036893|NCT00309699|Drug|Paliperidone ER|3 to 12 mg daily, flexibly dosed, for 12 weeks
12036894|NCT00309686|Drug|Paliperidone ER|
12036895|NCT00309673|Drug|lidocaine / Prilocaine|
12036896|NCT00309660|Drug|Rosiglitazone|
12036897|NCT00309647|Biological|Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine|2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
12036898|NCT00309647|Biological|Influenza Monovalent Whole virus (H5N1)|2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
12036899|NCT00309634|Biological|4 adjuvanted pandemic influenza candidate vaccines|
12036900|NCT00309634|Biological|4 non-adjuvanted pandemic influenza candidate vaccines|
12036901|NCT00309621|Drug|alitretinoin|
12036902|NCT00309608|Drug|Linagliptin|Linagliptin medium dose tablet once daily
12036903|NCT00309608|Drug|Linagliptin|Linagliptin high dose tablet once daily
12036904|NCT00309608|Drug|Linagliptin|Linagliptin low dose tablet once daily
12036905|NCT00309608|Drug|Placebo|Placebo tablets once daily
12036906|NCT00309608|Drug|Glimepiride|Glimepiride tablets once daily
12036907|NCT00309595|Device|stent|Cordis SMART™ Nitinol Stent System
12036908|NCT00309595|Device|balloon|balloon angioplasty
12036909|NCT00309569|Drug|Cyclophosphamide|Cyclophosphamide 600mg/m2
12036910|NCT00309569|Drug|Methotrexate|Methotrexate 40mg/m2
12036911|NCT00309569|Drug|Fluorouracil|Fluorouracil 600mg/m2
12036912|NCT00309569|Drug|Epirubicin|Epirubucin 60mg/m2 (only node-positive patients)
12036913|NCT00309569|Other|Surgery|Surgery
12036914|NCT00309556|Drug|Epirubicin|6 cycles 75mg/m2 i.v. day 1 q3w
12036915|NCT00309556|Drug|Docetaxel|6 cycles 75mg/m2 i.v. day 1 q3w
12036916|NCT00309556|Drug|Capecitabine|6 cycles 1000mg/m2 oral, day 1-14 q2d
12036917|NCT00309556|Drug|Trastuzumab|cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)
12036918|NCT00309543|Drug|Fluorouracil|
12036919|NCT00309543|Drug|Leucovorin|
12036920|NCT00309530|Drug|5-fluorouracil, levamisol, interferon|
12036921|NCT00309517|Drug|Fluourouracil|
12036922|NCT00309517|Drug|Leucovorin|
12036923|NCT00309517|Drug|MAb 17-1A|
12036924|NCT00309491|Drug|Tamoxifen alone|2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
12036925|NCT00309491|Drug|Tamoxifen + Aminoglutethimide|"2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years)
~1st therapy week:125mg/-/125mg Aminoglutethimide daily
~2nd therapy week: 125mg/-/250mg Aminoglutethimid daily
~as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily"
12036926|NCT00309478|Drug|Cyclophosphamide|Cyclophosphamide 600mg/m2
12036927|NCT00309478|Drug|Methotrexate|Methotrexate 40mg/m2
12036928|NCT00309478|Drug|Fluorouracil implant|Fluorouracil 600mg/m2
12036929|NCT00309478|Drug|Goserelin|Zoladex 3.6mg/28 days for 3 years
12036930|NCT00309478|Drug|Tamoxifen|Nolvadex 20mg/day for 5 years
12036931|NCT00309465|Drug|Lantus|Patients in Group 1 will administer 80% of their usual insulin glargine dose.
12036932|NCT00309465|Other|Insulin|Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
12037244|NCT00306891|Drug|Cediranib|45 mg oral dose
12036933|NCT00309465|Drug|Lantus|Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.
12036934|NCT00309452|Behavioral|Cognitive Behavioral Group Therapy|once per week
12036935|NCT00309452|Behavioral|Cognitive remediation|as needed
12036936|NCT00309452|Drug|Medications|Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
12036937|NCT00309452|Behavioral|MFG|Multi-Family psychoeducation Group based on the model published by McFarlane et al.
12036938|NCT00309452|Behavioral|Assertive case management|Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.
12036939|NCT00309452|Other|Treatment as Usual in the community|Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic.
12036940|NCT00309439|Procedure|ALA-rich diet|
12036941|NCT00309413|Drug|Placebo/Cannabidiol|600 mg/day, oral, capsules, 2 weeks, than cross-over
12036942|NCT00309413|Drug|Cannabidiol/Placebo|600 mg/day, oral, capsules, 2 weeks, than cross-over
12036943|NCT00309387|Dietary Supplement|Centrum|Multivitamin/mineral supplement containing US RDA levels of nutrients. 1 tablet a day for the expected duration of follow-up (on average 10 yrs).
12036944|NCT00309387|Other|Placebo|placebo tablets manufactured to mimic Centrum tablets.
12036945|NCT00309374|Drug|LPS 2ng/kg intravenous bolus|
12036946|NCT00309374|Drug|Simvastatin 80mg; administered daily p.o. over 5 days|
12036947|NCT00309374|Drug|Rosuvastatin 40mg; administered daily p.o. over 5 days|
12036948|NCT00309361|Drug|Phentolamine Mesylate (NV-101)|
12036949|NCT00309348|Other|Weekly measurement of graft flow|
12036950|NCT00309335|Drug|Phentolamine Mesylate (NV-101)|
12036951|NCT00309322|Drug|Phentolamine Mesylate (NV-101)|
12036952|NCT00309309|Drug|Rosiglitazone|
12036953|NCT00309296|Behavioral|smoking cessation|This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.
12036954|NCT00309283|Drug|Long-acting somatostatin|Patients randomized to treatment will be given intramuscularly long-acting somatostatin (Sandostatin-LAR, Novartis, Basel) at the dose of 40 mg every 28 days (in two intragluteal 20 mg injections).
12036955|NCT00309283|Other|Saline solution|Patients randomized to placebo will be given intramuscularly the same volume of solvent used to dissolve somatostatin every 28 days (in two intragluteal injections).
12036956|NCT00309270|Drug|Campath-1H|
12036957|NCT00309257|Drug|ACE I, ATA II and Statins|
12036958|NCT00309257|Drug|Benazepril, Valsartan and Fluvastatin|"Patients will be given a low dose of Benazepril, 10 mg/die,that, if tolerated, will be up-titrated, after a week,to 20 mg/day.
~Patients will be given Valsartan, 80 mg/die,up-titrated after a week to 160 mg/die. Fluvastatin will be started at 40 mg/die.If tolerated, will up-titrated to 80 mg/die. In case of liver, muscular or renal toxicity, fluvastatin will be back-titrated to 40 mg or withdrawn as deemed appropriate."
12036959|NCT00309244|Drug|Technosphere® Insulin Inhalation Powder|Inhalation, 15U/30U
12036960|NCT00309244|Drug|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)|BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
12036961|NCT00309231|Procedure|Islet Allotransplantation|Clinical islet transplantation using the Edmonton protocol, steroid free immunosuppression using sirolimus and tacrolimus and basilixumab induction therapy
12036962|NCT00309218|Drug|methylprednisolone|withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B
12036963|NCT00309205|Drug|dapivirine (TMC120) vaginal gel|
12036964|NCT00309192|Drug|Triamcinolone Acetonide 4 mg intravitreal injection|
12036965|NCT00309192|Procedure|ETDRS grid laser technique|
12036966|NCT00309179|Drug|E7820 plus cetuximab|Escalating doses from 40 mg/m^2 irinotecan plus E7820 in combination with cetuximab.
12036967|NCT00309166|Biological|Cervarix vaccine|All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
12036968|NCT00309166|Biological|Engerix-B vaccine|All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
12036969|NCT00309140|Drug|enzastaurin|500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity
12036970|NCT00309127|Behavioral|Multidisciplinary team care|
12036971|NCT00309114|Procedure|bacterial interference|
12036972|NCT00309101|Drug|tacrolimus|Oral
12036973|NCT00309088|Drug|tacrolimus|oral
12036974|NCT00309088|Drug|placebo|oral
12036975|NCT00309075|Drug|Gadopentetate dimeglumine (Magnevist)|Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day
12036976|NCT00309062|Biological|Recombinant birch pollen|
12036977|NCT00309049|Drug|Ixabepilone|Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of IV oral and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
12036978|NCT00309049|Drug|Ixabepilone|Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral IV and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
12037086|NCT00308113|Dietary Supplement|Coenzyme Q10|serum levels of greater or equal to 2.5 micrograms/mL.
12037245|NCT00306891|Drug|Cediranib 30 - 90 mg|oral tablet dose escalation
12036979|NCT00309049|Drug|Ixabepilone|Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral oral and IV dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
12036980|NCT00309036|Biological|Recombinant grass pollen|
12036981|NCT00309023|Drug|BMS-663513|mg/kg, intravenous (IV), 0.3, 1, 3, 6, 10 or 15 mg/kg, once every 3 weeks (q 3 wks), 12 weeks depending on response
12036982|NCT00308997|Device|1-hertz Repetitive Transcranial Magnetic Stimulation|Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
12036983|NCT00308997|Device|Active 1-Hertz Repetitive transcranial magnetic stimulation|Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
12036984|NCT00308971|Drug|Alpha, gamma, beta, and delta (mixed) tocopherols|approximately 666 IU daily (1 pill) for 4 months
12036985|NCT00308971|Drug|alpha lipoic acid|600 mg daily (2 pills 300 mg each) for 4 months
12036986|NCT00308971|Drug|placebo|placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months
12036987|NCT00308971|Drug|placebo|placebo for alpha lipoic acid; 2 pills daily for 4 months
12036988|NCT00308958|Device|High frequency chest wall oscillator|
12036989|NCT00308945|Drug|travoprost 0.004% (drug)|local drop application
12036990|NCT00308945|Drug|latanoprost 0.005% (drug)|local drop application
12036991|NCT00308932|Drug|HFA FP MDI|
12036992|NCT00308919|Drug|WST09|Treatment with WST09 Vascular Photodynamic therapy
12036993|NCT00308906|Drug|aminoglycoside|Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.
12036994|NCT00308893|Genetic|Genetic analysis|Compare BDNF polymorphism among responders and non-responders
12036995|NCT00308880|Drug|Transamin|
12036996|NCT00308867|Procedure|Photodynamic Therapy|
12036997|NCT00308867|Procedure|Cryosurgery|
12036998|NCT00308854|Procedure|Photodynamic Therapy|
12036999|NCT00308841|Drug|Lidocaine (drug)|
12037000|NCT00308815|Device|Automatic CPR machine|
12037001|NCT00308802|Procedure|Kidney transplantation|Participants in this study will have had a kidney transplant
12037002|NCT00308789|Procedure|Biphasic Infant flow NCPAP|Biphasic Nasal continuous positive airway pressure
12037003|NCT00308789|Procedure|CPAP|Continuous positive airway pressure
12037004|NCT00308776|Procedure|Cholecystokinin (CCK) infusion|Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline plus CCK.
12037005|NCT00308776|Procedure|Saline infusion|Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline only.
12037006|NCT00308763|Drug|Nicotine Patch|"After determining that it is appropriate to dispense study medication to a participant, the dosing regimen will be determined. Participants who report smoking more than 20 cigarettes each day will be initially placed on the 21 mg patch; participants who report smoking 10 - 19 cigarettes each day will be initially placed on the 14 mg patch; participants who report smoking 5 - 9 cigarettes will be initially placed on the 7 mg patch.
~If a participant is initially placed on the 21 mg patch, the following dosing schedule will occur: 21 mg patch for 4 weeks, 14 mg patch for 4 weeks, 7 mg patch for 2 weeks, and then off. If a participant is initially placed on the 14 mg patch, the following dosing schedule will occur: 14 mg patch for 6 weeks, 7 mg patch for 4 weeks, and then off. If a participant is initially placed on the 7 mg patch, the following dosing schedule will occur: 7 mg patch for 10 weeks, and then off."
12037007|NCT00308763|Drug|Sustained Release Bupropion|Participants will receive the sustained-release bupropion 150 mg tablet in the morning for four days. If this dose is well-tolerated, then the dose will be increased to a 150 mg tablet twice daily, with at least 8 hours between the two doses. The sustained-release bupropion medication will begin at the randomization visit (RV) which is approximately one week before the quit date. At the RV, the participant should be dispensed enough of the 150 mg tablets of the sustained-release bupropion or placebo to return for the first follow-up visit with instructions on use. Participants will be evaluated by telephone on their quit date approximately one week after the RV to assess safety. We will discontinue the sustained-release bupropion at the second follow-up visit, at which time participants will have received sustained-release bupropion for approximately 11 weeks.
12037008|NCT00308750|Drug|enzastaurin|1125-1200 mg loading dose then 500 mg, oral, daily, until disease progression
12037009|NCT00308750|Drug|pemetrexed|500 mg/m2, IV, q 21 days, six 21 day cycles or progressive disease
12037010|NCT00308750|Drug|docetaxel|75 mg/m2, IV, q 21 days, six 21 day cycles or progressive disease
12037011|NCT00308750|Drug|carboplatin|AUC 6, IV, q 21 days, six 21 day cycles or progressive disease
12037012|NCT00308737|Drug|Technosphere® Insulin Inhalation Powder|Inhalation, 15U/30U
12037013|NCT00308737|Drug|Usual Care|Subjects will receive antidiabetes treatment at the discretion of their physicians
12037014|NCT00308724|Behavioral|Cognitive Behavior Therapy|8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
12037015|NCT00308724|Behavioral|Telephone check-in|Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
12037016|NCT00308711|Drug|Misoprostol vaginal insert 100 mcg|Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
12037087|NCT00308100|Drug|Hydroxyethylstarch 130/0.4|HES 130/0.4, administered intra- and perioperatively, max. daily dose: 33ml/kg BW; if needed, additionally albumin is administered (ratio crystalloid to colloid= 1:1)
12037088|NCT00308100|Drug|5% Albumin|5% albumin, administered intra- and perioperatively
12037246|NCT00306878|Drug|Abatacept|
12037017|NCT00308711|Drug|Misoprostol vaginal insert 50 mcg|Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
12037018|NCT00308711|Drug|Dinoprostone vaginal insert (Cervidil)|Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
12037019|NCT00308685|Drug|Albuterol 90mcg|
12037020|NCT00308685|Drug|Placebo|Placebo
12037021|NCT00308659|Procedure|FOB protected distal microbiological samplings|
12037022|NCT00308620|Drug|chloroquine phosphate|250mg or 500mg PO (by mouth) QDay
12037023|NCT00308620|Drug|Placebo|Placebo once daily for 8 weeks
12037024|NCT00308607|Drug|Bevacizumab (Avastin)|
12037025|NCT00308607|Drug|dacarbazine|
12037026|NCT00308607|Drug|interferon-alfa-2a (Roferon-A)|
12037027|NCT00308594|Drug|Dexamethasone|
12037028|NCT00308581|Biological|Certolizumab pegol|400mg Certolizumab Pegol, Q4W, administered 4-weekly
12037029|NCT00308581|Biological|Certolizumab pegol|400mg Certolizumab Pegol, Q2W, administered 2-weekly
12037030|NCT00308581|Other|Placebo|placebo administered 4-weekly in Active 1
12037031|NCT00308568|Behavioral|Mailed educational brochure|
12037032|NCT00308555|Drug|Cannabis|
12037033|NCT00308542|Drug|dexamethasone|
12037034|NCT00308529|Drug|irinotecan|
12037035|NCT00308529|Drug|carboplatin|
12037036|NCT00308529|Drug|bevacizumab|
12037037|NCT00308529|Procedure|Radiation Therapy|
12037038|NCT00308516|Drug|5-Fluorouracil|"Combined Modality Treatment:
~fluorouracil 225mg/m2 IV continuous infusion days 1-42
~Systemic Treatment:
~5-fluorouracil 400 mg/m2 bolus 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15"
12037039|NCT00308516|Drug|Bevacizumab|"Combined Modality Treatment:
~bevacizumab 5mg/kg IV infusion days 1, 15, and 29
~Systemic Treatment:
~bevacizumab 5 mg/kg days 1 and 15"
12037040|NCT00308516|Procedure|Radiation Therapy|radiation 1.8 Gy/day or 28 fractions weeks 1-6
12037041|NCT00308516|Drug|Oxaliplatin|"Systemic Treatment:
~oxaliplatin 85 mg/m2 days 1 and 15"
12037042|NCT00308516|Drug|Leucovorin|"Systemic Treatment:
~leucovorin 350 mg prior to FU on days 1 and 15"
12037043|NCT00308503|Drug|eplivanserin (SR46349)|oral administration
12037044|NCT00308503|Drug|placebo|oral administration
12037045|NCT00308490|Drug|iron sucrose|
12037046|NCT00308477|Drug|dexamethasone|
12037047|NCT00308464|Drug|PHA-794428|
12037048|NCT00308451|Drug|Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)|
12037049|NCT00308438|Drug|Teduglutide (ALX-0600)|0.1 mg/kg injected subcutaneously daily
12037050|NCT00308425|Drug|Enteric-coated Mycophenolate sodium (EC-MPS), valsartan|
12037051|NCT00308412|Biological|rHPIV3cp45|Placebo for rHPIV3cp45 vaccine is 1X L-15.
12037052|NCT00308412|Biological|Placebo|Placebo for rHPIV3cp45 vaccine
12037053|NCT00308399|Drug|Itopride|
12037054|NCT00308386|Behavioral|Nurse Case Management intervention|Intervention is meeting with nurse case managers
12037055|NCT00308373|Drug|Metformin vs Thiazolidinedione (Pioglitazone)|
12037056|NCT00308360|Drug|Risperidone, divalproex|
12037057|NCT00308347|Drug|MK0954, losartan / Duration of Treatment: mean 3.4 years|
12037058|NCT00308347|Drug|Placebo / Duration of Treatment: mean 3.4 years|
12037059|NCT00308334|Drug|Domperidone|10 mg po TID X 14 days
12037060|NCT00308334|Drug|Placebo- Sugar pill|placebo po TID x 14 days
12037061|NCT00308321|Drug|long term tapering of prednisolone|60mg/m2/day (0-4 weeks); 60mg/m2 alternate days (5-6 weeks); 50mg/m2 alternate days (week 7-8); 40mg/m2 alternate days (week 9-10); 30mg/m2 alternate days (week 11-12); 20mg/m2 alternate days (week 13-14); 10mg/m2 alternate days (week 15-16)
12037062|NCT00308321|Drug|standard prednisolone treatment|60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8
12037063|NCT00308308|Drug|Technosphere Insulin|Inhalation, 15U/30U
12037064|NCT00308308|Drug|Active comparator|sc injectable insulin
12037065|NCT00308295|Drug|Fish oil capsules|
12037066|NCT00308295|Drug|matched placebo capsules|
12037067|NCT00308282|Drug|LY2127399|30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
12037068|NCT00308282|Drug|Placebo|IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
12037069|NCT00308269|Drug|Vintafolide IV Bolus|Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate
12037070|NCT00308269|Drug|Vintafolide IV Infusion|Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate
12037071|NCT00308256|Behavioral|nurse-counselling|Phone calls performed by nurse 15 days after each monthly visit
12037072|NCT00308243|Drug|Sodium Pyruvate in 0.9% Sodium Chloride Solution|
12037073|NCT00308230|Procedure|Six minute walk test|
12037074|NCT00308230|Behavioral|Minnesota Living with Heart Failure Questionnaire|
12037075|NCT00308204|Drug|Raptiva|injection
12037076|NCT00308191|Drug|Formoterol Fumarate|
12037077|NCT00308191|Drug|Tiotropium Bromide|
12037078|NCT00308178|Drug|Abraxane|Following 4 cycles (8 weeks) of adjuvant chemotherapy (adriamycin and cytoxan), abraxane will be give every 2 weeks for 4 cycles(8 weeks)
12037079|NCT00308165|Procedure|Convection-Enhanced Delivery|microinfusion pumps to deliver chemotherapy directly into brain tumors
12037080|NCT00308165|Drug|Topotecan|chemotherapeutic drug for the treatment of brain tumors
12037081|NCT00308152|Drug|Infusion of 1 litre of normal saline before colonoscopy|Prehydration with normal saline
12037082|NCT00308139|Drug|exenatide, long acting release|
12037083|NCT00308139|Drug|exenatide|
12037084|NCT00308126|Drug|Hydroxyethyl Starch 130/0.4 (Voluven)|
12037085|NCT00308113|Drug|Prednisone|Prednisone 0/75 mg/kg/day.
12037242|NCT00306917|Device|coated femoral hip stem|total hip replacement
12037089|NCT00308087|Drug|Sargramostim (Leukine)|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
12037090|NCT00308087|Drug|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
12037091|NCT00308074|Drug|Aripiprazole|open-label, flexible-dosing
12037092|NCT00308061|Biological|FMP1/AS02A|FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
12037093|NCT00308061|Biological|Imovax Rabies Vaccine|Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.
12037094|NCT00308048|Drug|Pegylated Interferon alfa 2b and ribavirin|
12037095|NCT00308022|Device|High Frequency Percussive Ventilation|
12037096|NCT00308009|Procedure|Vaginal Repair for prolapse, TVT procedure|"TVT at the time of Vaginal Repair
~TVT 3 months after Vaginal Repair"
12037097|NCT00308009|Procedure|TVT and Prolapse surgery|"TVT at the time of Prolapse surgery
~TVT 3 months after Prolapse Surgery"
12037098|NCT00307996|Drug|Coenzyme Q10 (drug)|
12037099|NCT00307970|Drug|HFA FP MDI|
12037100|NCT00307970|Device|conventional chamber/mask; anti-static chamber/mask|
12037101|NCT00307957|Device|Pillar Palatal Implants|
12037102|NCT00307944|Drug|Pantoprazole|
12037103|NCT00307931|Biological|Certolizumab pegol|"certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12.
~Treatment duration: 12 weeks."
12037104|NCT00307918|Device|acupuncture|
12037105|NCT00307905|Drug|Traumeel S|homeopathic remedy
12037106|NCT00307905|Drug|Placebo remedy|identical size, shape and taste of treatment medication
12037107|NCT00307892|Drug|Traumeel S: intra-operative irrigation + oral ingestion|homeopathic remedy
12037108|NCT00307892|Drug|Placebo|placebo remedy
12037109|NCT00307879|Drug|Drug: G-CSF (Dong-A pharmaceutical, Seoul, Korea)|
12037110|NCT00307879|Procedure|collection of mobilized peripheral blood stem cells|
12037111|NCT00307879|Procedure|Intracoronary infusion of mobilized cells|
12037112|NCT00307866|Procedure|Resovist (BAY86-4884, SH U 555 A)|Single bolus injection, followed by MRI
12037113|NCT00307853|Drug|Traumeel S|All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
12037114|NCT00307853|Other|Traumeel S|All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
12037115|NCT00307853|Other|Placebo|All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
12037116|NCT00307840|Drug|paricalcitol|
12037117|NCT00307827|Drug|Visilizumab|Visilizumab administered intravenously once per day for two days
12037118|NCT00307814|Drug|Epoetin Alfa|
12037119|NCT00307801|Drug|Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|1 pill per day taken orally over 7 cycles of 28 pills per cycle
12037120|NCT00307801|Drug|Placebo|1 pill per day taken orally over 7 cycles of 28 pills per cycle
12037121|NCT00307788|Procedure|acupuncture|acupuncture
12037122|NCT00307775|Drug|oestradiol|
12037123|NCT00307762|Behavioral|intensified gait trainer|Intensity and type of rehabilitation after stroke. Gait trainér + or overground walking + other gait-oriented physioteharpy. The third group (control patients) received traditional (ordinary) physiotherapy witn o efforts to intensify it.
12037124|NCT00307749|Drug|Placebo|once daily for 24 weeks
12037125|NCT00307749|Drug|MCC-257|20mg, once daily for 24 weeks
12037126|NCT00307749|Drug|MCC-257|40mg, once daily for 24 weeks
12037127|NCT00307749|Drug|MCC-257|80mg, once daily for 24 weeks
12037128|NCT00307736|Drug|5-fluorouracil|Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
12037129|NCT00307736|Drug|bevacizumab|Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
12037130|NCT00307736|Drug|erlotinib|Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
12037131|NCT00307736|Procedure|External beam radiation therapy (EBRT)|Given on days 1-5 and 8-12
12037132|NCT00307723|Drug|bevacizumab|Intravenously on days 1, 15 and 29 of the first cycle. Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.
12037133|NCT00307723|Drug|5-Fluorouracil|Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
12037134|NCT00307723|Drug|Oxaliplatin|Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
12037135|NCT00307723|Drug|gemcitabine|Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
12037136|NCT00307723|Procedure|External Beam Radiation Therapy|Monday through Friday ending on day 38 of cycle 1
12037137|NCT00307710|Biological|Trivalent Baculovirus-expressed Influenza HA vaccine|Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.
12037138|NCT00307697|Procedure|receipt of copy of psychiatic assessment letter|
12037139|NCT00307684|Drug|double blind placebo|matching placebo tablets once daily for 4 weeks
12037140|NCT00307684|Drug|double blind PR OROS methylphenidate|18, 36, 54,72 or 90 mg/day once daily for 4 weeks
12037141|NCT00307684|Drug|open label PR OROS methylphenidate|Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)
12037142|NCT00307671|Drug|prednisone, methylprednisolone,cyclophosphamides|treatment conventional
12037143|NCT00307671|Drug|Cyclophosphamide, Azathioprine,prednisone,methylprednisolone|reduction dose
12037144|NCT00307671|Drug|Mycophenolate mofetil,methotrexate|in the treatment conventional and in the reduction dose
12037145|NCT00307658|Drug|Intravenous immunoglobulins (human immunoglobulins G)|
12037146|NCT00307645|Drug|Cyclophosphamide|
12037147|NCT00307645|Drug|Mycophenolate mofetil|
12037148|NCT00307645|Drug|Azathioprine|
12037149|NCT00307645|Drug|Prednisone (and methylprednisolone)|
12037150|NCT00307632|Drug|Norelgestromine (NLGM)/ethinyl estradiol (EE)|Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).
12037151|NCT00307619|Drug|topiramate|
12037152|NCT00307606|Drug|Solu-medrol 125 mg|
12037153|NCT00307593|Drug|Infliximab|Infliximab
12037154|NCT00307593|Drug|Rituximab|Rituximab
12037155|NCT00307580|Drug|Cathflo Activase (Alteplase)|
12037156|NCT00307567|Biological|Pneumococcal (vaccine)|
12037157|NCT00307554|Biological|Pneumococcal (vaccine)|
12037158|NCT00307541|Biological|Pneumococcal (vaccine)|
12037159|NCT00307528|Biological|Pneumococcal vaccine GSK513026|Two-dose intramuscular injection. Five different formulations, each administered to one Group
12037160|NCT00307528|Biological|Pneumovax 23™|Single dose intramuscular injection.
12037161|NCT00307515|Drug|Fibrin Sealant 2 (FS2)|FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
12037162|NCT00307515|Device|Oxidized Regenerated Cellulose (Surgicel)|Commercially available Surgicel used within label.
12037163|NCT00307502|Drug|Nevirapine|tablets 200 mg, 400 mg/day
12037164|NCT00307502|Drug|Efavirenz|tablets 600 mg, 600 mg/day
12037165|NCT00307502|Drug|Indinavir/ritonavir|"Indinavir: capsules 400 mg, 1600 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
12037166|NCT00307502|Drug|Nelfinavir|tablets 250 mg, 2500 mg/day
12037167|NCT00307502|Drug|Saquinavir/ritonavir|"Saquinavir: tablets 500 mg, 2000 mg/day
~Ritonavir: tablets 100 mg, 200 mg/day"
12037168|NCT00307502|Drug|Lopinavir/ritonavir|tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day
12037169|NCT00307502|Drug|Atazanavir|capsules 200 mg, 400 mg/day
12037170|NCT00307502|Drug|Atazanavir/ritonavir|"Atazanavir: capsules 150 mg, 300 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
12037171|NCT00307502|Drug|Fos-amprenavir/ritonavir|"Fos-amprenavir: capsules 700 mg, 1400 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
12037172|NCT00307502|Drug|Tipranavir/ ritonavir|"Tipranavir: tablets 250 mg, 1000 mg/day
~Ritonavir: capsules 100 mg, 400 mg/day"
12037173|NCT00307502|Drug|Darunavir/ritonavir|"Darunavir: tablets 300 mg, 1200 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
12037174|NCT00307489|Drug|tenofovir DF|300 mg tablet, once daily (QD)
12037175|NCT00307489|Drug|emtricitabine /tenofovir DF|emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet)
12037176|NCT00307476|Device|Rusch Nasopharyngeal Airway|
12037177|NCT00307463|Procedure|strict volume control policy|strict volume control by UF and dietary salt restriction
12037178|NCT00307463|Procedure|antihypertensive drugs administration|continue antihypertensive medications
12037179|NCT00307450|Drug|Levetiracetam|up to 200 mg per day in two dosages per day.
12037180|NCT00307437|Drug|Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg|Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
12037181|NCT00307437|Drug|Ustekinumab (CNTO 1275) 45 mg|Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
12037182|NCT00307437|Drug|Ustekinumab (CNTO 1275) 90 mg|Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
12037183|NCT00307424|Device|AutoCPAP|
12037184|NCT00307424|Device|FixCPAP|
12037185|NCT00307411|Drug|Growth hormone|
12037186|NCT00307398|Drug|Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg|One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.
12037187|NCT00307398|Other|Anecortave Acetate Vehicle|One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.
12037188|NCT00307333|Device|HeRO heart rate characteristics monitor|24 hour continuous HRC monitoring with display
12037189|NCT00307320|Behavioral|Relaxation Training|Relaxation techniques training
12037190|NCT00307307|Drug|Niacin/simvastatin compared to simvastatin alone at 2 doses|
12037191|NCT00307294|Drug|Thalidomide|100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
12037192|NCT00307294|Drug|Doxil|On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
12037193|NCT00307255|Drug|gemcitabine hydrochloride|1000 mg/m2 on days 1 and 8 of each 21 day cycle
12037194|NCT00307255|Drug|paclitaxel albumin-stabilized nanoparticle formulation|260 mg/m2 to 340 mg/m2 (dose will depend on when subject enters the study). Paclitaxel will be given on day 1 of each 21 day cycle (every 3 weeks)
12037195|NCT00307242|Drug|Adefovir Dipivoxil|
12037196|NCT00307229|Biological|adenoviral vector encoding rat Her-2/neu|Group 1 1 x 10'7 pfu (2.5 X 10'6 pfu per injection site)(1.6 x 10'9 particles) Group 2 5 x 10'7 pfu (1.25 X 10'7 pfu per injection site)(8.0 x10'9 particles) Group 3 1 x 10'8 pfu (5 x 10'7 pfu per injection site)(1.6 x10'10 particles)
12037243|NCT00306904|Drug|bevasiranib|
12037197|NCT00307216|Behavioral|Graduated Recovery Intervention Program (GRIP)|GRIP is a manual-based comprehensive psychosocial intervention for people recovering from an initial episode of nonaffective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management, substance use, persistent symptoms, and functional recovery.
12037198|NCT00307216|Behavioral|Treatment as usual (TAU)|Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
12037199|NCT00307203|Drug|bupropion SR|Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
12037200|NCT00307203|Behavioral|Cognitive Behavioral Group Therapy|Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.
12037201|NCT00307203|Drug|nicotine replacement therapy|Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
12037202|NCT00307177|Biological|Trivalent inactivated influenza vaccine|Standard Trivalent inactivated influenza vaccine, licensed. Arm A receives standard dose of 15 mcg IM on day 0.
12037203|NCT00307177|Biological|Trivalent Baculovirus-expressed Influenza HA vaccine|Trivalent Baculovirus-expressed influenza HA vaccine (Recombinant rHA0): Arms B, C and D receive 15 mcg, 45 mcg or 135 mcg IM dose on Day 0.
12037204|NCT00307164|Drug|NucleomaxX|36 g sachet taken orally three times daily
12037205|NCT00307164|Drug|NucleomaxX placebo|36 g placebo sachet taken orally three times daily
12037206|NCT00307151|Drug|Lamivudine|4 mg/kg twice daily
12037207|NCT00307151|Drug|Lopinavir/ritonavir|16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg
12037208|NCT00307151|Drug|Nevirapine|Initially: 4 mg/kg for 14 days, then 7 mg/kg twice daily. In protocol version 2.0, Letter of Amendment 1 (September 2007), NVP dose increased to conform with WHO guidelines to: 160 to 200 mg/m^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m^2/dose to max 200 mg twice daily
12037209|NCT00307151|Drug|Zidovudine|180 mg/m^2 twice daily
12037210|NCT00307138|Drug|hetastarch|
12037211|NCT00307125|Drug|Rituximab plus immunosuppression|"Genetically engineered monoclonal antibody directed against the CD20 antigen on B cells and is known to deplete B cells when administered intravenously. Generally used in the treatment of non-Hodgkin's lymphoma
~Standard immunosuppression is site-specific."
12037212|NCT00307125|Drug|Placebo plus immunosuppression|"Placebo dosing: Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
~Standard immunosuppression is site-specific."
12037213|NCT00307099|Drug|Meropenem|Meropenem 1 gram intravenously every 8 hours for 3 days (9 doses), then an additional 5 days if the Clinical Pulmonary Infection Score is greater than 6.
12037214|NCT00307099|Drug|Standard antibiotic therapy|Standard intravenous antibiotic therapy for a minimum of 8 days.
12037215|NCT00307086|Drug|Bortezomib|the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant
12037216|NCT00307086|Drug|Melphalan|Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes
12037217|NCT00307086|Procedure|PBSCT|PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)
12037218|NCT00307073|Device|Implantable Pulse Generator|
12037219|NCT00307060|Drug|MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks|
12037220|NCT00307060|Drug|losartan / Duration of Treatment: 6 weeks|
12037221|NCT00307047|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12037222|NCT00307047|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12037223|NCT00307034|Biological|GSK Biologicals' 10-valent pneumococcal conjugate vaccine.|Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).
12037224|NCT00307034|Biological|Infanrix hexa.|Intramuscular injection, 3 doses (2-4-11 months of age schedule).
12037225|NCT00307034|Biological|Infanrix-IPV/Hib.|Intramuscular injection, 3 doses (2-4-11 months of age schedule).
12037226|NCT00307021|Biological|GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049|3-dose intramuscular injection, 2 different formulations
12037227|NCT00307008|Biological|Pneumovax 23™|Single dose intramuscular injection
12037228|NCT00306995|Biological|SB218352_15|Non-adjuvanted pandemic influenza A formulation 1 vaccine
12037229|NCT00306995|Biological|SB218352_8|Non-adjuvanted pandemic influenza A formulation 2 vaccine
12037230|NCT00306995|Biological|SB218352_4|Non-adjuvanted pandemic influenza A formulation 3 vaccine
12037231|NCT00306995|Biological|SB218352_2|Non-adjuvanted pandemic influenza A formulation 4 vaccine
12037232|NCT00306995|Biological|SB218352_8AL|Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
12037233|NCT00306995|Biological|SB218352_4AL|Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
12037234|NCT00306995|Biological|SB218352_2AL|Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine
12037235|NCT00306982|Biological|Fluarix|
12037236|NCT00306969|Drug|bexarotene|
12037237|NCT00306969|Device|photopheresis|
12037238|NCT00306956|Behavioral|offer a pacifier|To offer a pacifier to normal newborn infants at 15 days of age
12037239|NCT00306943|Biological|Influsplit SSW®|
12037240|NCT00306930|Device|Acetabular cup|Acetabular cup replacement
12037241|NCT00306917|Device|non-coated femoral hip stem|total hip replacement
12037644|NCT00303771|Drug|leucovorin calcium|
12037247|NCT00306852|Procedure|Baerveldt implant|Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
12037248|NCT00306852|Procedure|Trabeculectomy with mitomycin C|Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant
12037249|NCT00306839|Procedure|standardized Lichtenstein technique|
12037250|NCT00306826|Drug|pioglitazone|
12037251|NCT00306826|Drug|simvastatin|
12037252|NCT00306826|Drug|pioglitazone + simvastatin|
12037253|NCT00306813|Drug|Revlimid|
12037254|NCT00306800|Procedure|Photodynamic therapy with methyl aminolevulinate cream|
12037255|NCT00306787|Drug|Famciclovir|Famciclovir 500 mg tablet
12037256|NCT00306787|Drug|Valacyclovir|Valacyclovir 500 mg capsule
12037257|NCT00306787|Drug|Placebo matching famciclovir|Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
12037258|NCT00306787|Drug|Placebo matching valacyclovir|Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
12037259|NCT00306774|Dietary Supplement|Vitamin D (cholecalciferol)|2,000 IU vitamin D capsule per day for 2 years
12037260|NCT00306774|Dietary Supplement|Placebo|Placebo capsule per day for 2 years
12037261|NCT00306761|Device|Dynamic Wheelchair Seating System|
12037262|NCT00306748|Drug|MD-1100 Acetate|
12037263|NCT00306735|Drug|Palonosetron|
12037264|NCT00306722|Drug|AQUAVAN® (fospropofol disodium) Injection|
12037265|NCT00306709|Behavioral|culturally adapted behavior change|Behavior change strategies which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support.
12037266|NCT00306696|Drug|Rosiglitazone|
12037267|NCT00306696|Drug|spironolactone|
12037268|NCT00306696|Drug|hydrochlorothiazide|
12037269|NCT00306696|Drug|frusemide|
12037270|NCT00306683|Drug|DIAZOXIDE|
12037271|NCT00306670|Drug|Rituxan|Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies
12037272|NCT00306670|Drug|prednisone|<30 mg/day
12037273|NCT00306657|Procedure|Optic nerve sheath fenestration|
12037274|NCT00306644|Drug|Rosiglitazone|study drug
12037275|NCT00306631|Drug|MKC-1|Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle
12037276|NCT00306618|Drug|Panzem Nanocrystal Colloidal Dispersion|Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing
12037277|NCT00306605|Behavioral|Questionnaire|Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization
12037278|NCT00306592|Biological|BG00002 (natalizumab)|
12037279|NCT00306566|Biological|CYT004-MelQbG10|
12037280|NCT00306553|Biological|CYT004-MelQbG10|
12037281|NCT00306540|Drug|Quetiapine Fumarate|oral flexible dose
12037282|NCT00306540|Drug|quetiapine fumarate placebo|oral 0 mg
12037283|NCT00306527|Biological|Cell culture derived influenza vaccine|as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
12037284|NCT00306527|Biological|egg-derived influenza subunit vaccine|as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
12037285|NCT00306514|Biological|CYT004-MelQbG10|
12037286|NCT00306501|Procedure|Swallowing Training|Swallowing Training with press of button
12037287|NCT00306488|Drug|OT-551 antioxidant eye drop|0.45% concentration of OT-551 eye drops were given three times a day on participants with geographic atrophy area for up to three years. Participants had one eye randomized to receive the eye drop and the fellow eye was observed.
12037288|NCT00306475|Drug|divalproex sodium ER|divalproex sodium ER1000 mg
12037289|NCT00306475|Drug|placebo|placebo identical in appearance to active comparator
12037290|NCT00306462|Drug|Magnesium sulfate|Intravenous magnesium sulfate 6g bolus, then increased by 1 g/hour till a maximum of 5g/hour; gradually wean down to 2 g/hour for a total of 48 hours once uterine contractions is < 6/hour.
12037291|NCT00306462|Drug|Oral Nifedipine or placebo|Oral nifedipine or placebo at 20 mg every 30 minutes for the first hour, then 20 mg every 3 to 6 hours not to exceed 180 mg in 24 hours, keep maintenance dose at 20 mg every 3 to 6 hours for a total of 48 hours if uterine contractions is < 6/hour.
12037292|NCT00306449|Behavioral|Small group seminar-based educational intervention|
12037293|NCT00306436|Procedure|comprehensive management|
12037294|NCT00306423|Procedure|Other: Exercise|exercise 3 times per week for 12 weeks
12037295|NCT00306410|Drug|colecalciferol|
12037296|NCT00306397|Drug|Rapamycin|Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
12037297|NCT00306384|Drug|Alogliptin|Alogliptin tablets.
12037298|NCT00306371|Device|1450nm diode laser|
12037299|NCT00306358|Drug|Vitamin B12 (Cyanocobalamin)|
12037300|NCT00306345|Behavioral|Outreach|
12037301|NCT00306332|Procedure|T-cell and B-cell depletion|
12037302|NCT00306319|Drug|moxifloxacin|
12037303|NCT00306306|Device|Reprieve Endovascular Temperature Therapy System|
12037304|NCT00306293|Drug|valacyclovir|valacyclovir
12037305|NCT00306280|Device|Phototherapy|
12037306|NCT00306267|Drug|epoetin alfa|
12037307|NCT00306254|Drug|PD 0348292|
12037308|NCT00306254|Drug|Enoxaparin|
12037309|NCT00306241|Biological|HPV-16/18 L1 VLP AS04|
12037310|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis
12037311|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis
12037312|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis
12037313|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis
12037314|NCT00306215|Drug|CCX282-B|CCX282-B or placebo capsules
12037315|NCT00306202|Drug|Dasatinib|"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.
~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment > 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after end-of-treatment (EOT)."
12037316|NCT00306202|Drug|Dasatinib|"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment > 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after EOT."
12037317|NCT00306202|Drug|Dasatinib|"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment > 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after EOT."
12037318|NCT00306189|Drug|100 mg AMG 162|100 mg AMG 162 (denosumab) SC every 6 months
12037319|NCT00306189|Drug|60 mg AMG 162|60 mg AMG 162 (denosumab) SC every 6 months
12037320|NCT00306189|Drug|14 mg AMG 162|14 mg AMG 162 (denosumab) SC every 6 months
12037321|NCT00306189|Drug|Placebo|Placebo SC every 6 months
12037322|NCT00306176|Drug|Rosiglitazone|
12037323|NCT00306163|Drug|Ciclesonide|inhaled Ciclesonide 160 µg, once daily in the morning
12037324|NCT00306163|Drug|Fluticasone|inhaled Fluticasone 100 µg, twice daily
12037325|NCT00306150|Drug|Trasylol (Aprotinin, BAYA0128)|Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.
12037326|NCT00306150|Drug|Placebo|Placebo is used according to the description of Arm 1
12037327|NCT00306137|Drug|Trasylol (Aprotinin, BAYA0128)|"Subjects successfully meeting all screening criteria will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride.
~Subjects will be stratified into one of the 4 following strata:
~Stratum 1: complete primary pneumonectomy
~Stratum II: decortication or completion pneumonectomy
~Stratum III: esophagectomy by transhiatal approach
~Stratum IV: esophagectomy by transthoracic approach"
12037328|NCT00306137|Drug|Placebo|Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
12037329|NCT00306124|Drug|Levodopa|
12037330|NCT00306111|Drug|pegfilgrastim|Single dose (6mg) one day after chemotherapy
12037331|NCT00306098|Drug|islets|Islet transplantation
12037332|NCT00306085|Genetic|Autologous bone marrow cells|
12037333|NCT00306072|Drug|nutritional herbal extract from Salacia oblonga|
12037334|NCT00306059|Procedure|Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury|Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.
12037335|NCT00306046|Drug|Bisphosphonate treatment|
12037336|NCT00306033|Drug|Intravenous ImmuneGlobulin|
12037337|NCT00306020|Drug|topical morphine|
12037338|NCT00305968|Behavioral|patient education|Patient education group
12037339|NCT00305955|Device|Spectacles|optimal spectacle correction
12037340|NCT00305942|Drug|Topotecan|Topotecan 4mg/m2 IV on days 1, 8.
12037341|NCT00305942|Drug|carboplatin|Carboplatin AUC=5 IV day 1 only .
12037342|NCT00305929|Drug|Treatment with Tookad VTP|
12037343|NCT00305929|Drug|Treatment with Tookad VTP|Tookad 2 mg/kg
12037344|NCT00305929|Drug|Treatment with Tookad VTP|2 mg/kg
12037345|NCT00305916|Procedure|Multislice spiral computed tomography coronary angiography|
12037346|NCT00305916|Procedure|conventional coronary angiography|
12037347|NCT00305903|Drug|Rivastigmine, memantine|
12037348|NCT00305890|Behavioral|Lifestyle Behavioral Weight Management Program|The lifestyle behavioral weight management program will focus on lifestyle, exercise, attitudes, relationships, and nutrition. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.
12037349|NCT00305890|Behavioral|Pain-Coping Skills Training|The pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing adaptive strategies to control and decrease pain. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.
12037350|NCT00305890|Other|Standard Care|Standard care will include routine medical care.
12037351|NCT00305877|Biological|cetuximab|Given IV
12037352|NCT00305877|Drug|gemcitabine hydrochloride|Given IV
12037353|NCT00305877|Drug|capecitabine|Given orally
12037354|NCT00305877|Radiation|radiation therapy|Undergo radiation therapy
12037355|NCT00305877|Biological|bevacizumab|Given IV
12037356|NCT00305877|Other|laboratory biomarker analysis|Correlative studies
12037357|NCT00305864|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo radiotherapy
12037358|NCT00305864|Drug|Motexafin Gadolinium|Given IV
12037359|NCT00305864|Drug|Temozolomide|Given orally
12037360|NCT00305851|Procedure|music therapy (books on tape)|
12037361|NCT00305851|Procedure|psychosocial assessment and care|
12037362|NCT00305851|Procedure|quality-of-life assessment|
12037363|NCT00305851|Behavioral|Music Video|Song writing, recording the song with a digital accompaniment track, completing a video layout worksheet (determining the contents of the video), taking photos or making drawings for the video, and viewing clip art and pictures on a computer.
12037364|NCT00305838|Drug|tamoxifen citrate|
12037365|NCT00305838|Other|diagnostic laboratory biomarker analysis|
12037366|NCT00305825|Biological|bevacizumab|
12037367|NCT00305825|Drug|letrozole|
12037368|NCT00305812|Drug|dexamethasone|
12037369|NCT00305812|Drug|lenalidomide|
12037370|NCT00305812|Drug|melphalan|
12037371|NCT00305799|Procedure|management of therapy complications|Patients will complete three self-reported questionnaires including the Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. Patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. Patients will also undergo a hearing test.
12037372|NCT00305786|Drug|gemcitabine hydrochloride|
12037373|NCT00305786|Drug|oxaliplatin|
12037374|NCT00305773|Drug|vorinostat|Given orally once daily
12037375|NCT00305773|Drug|vorinostat|Given orally three times daily
12037376|NCT00305760|Drug|Cetuximab|Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.
12037377|NCT00305760|Biological|Pancreatic tumor vaccine|Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.
12037378|NCT00305760|Drug|Cyclophosphamide|Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.
12037379|NCT00305747|Drug|BR-DIM|75 mg orally (po) twice daily. May continue treatment for 12 months, however patients will be taken off study if their disease progresses, or have intolerable side effects.
12037380|NCT00305734|Drug|bortezomib|Given IV
12037381|NCT00305734|Drug|gemcitabine hydrochloride|Given IV
12037382|NCT00305734|Other|laboratory biomarker analysis|Correlative studies
12037383|NCT00305708|Biological|anti-thymocyte globulin|
12037384|NCT00305708|Drug|busulfan|
12037385|NCT00305708|Drug|fludarabine phosphate|
12037386|NCT00305708|Procedure|allogeneic bone marrow transplantation|
12037387|NCT00305708|Procedure|peripheral blood stem cell transplantation|
12037388|NCT00305708|Procedure|umbilical cord blood transplantation|
12037389|NCT00305708|Radiation|radiation therapy|
12037390|NCT00305695|Other|Laboratory Biomarker Analysis|Correlative studies
12037391|NCT00305695|Drug|Zoledronic Acid|Given IV
12037392|NCT00305682|Biological|anti-thymocyte globulin|Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
12037393|NCT00305682|Drug|cyclophosphamide|Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
12037394|NCT00305682|Drug|Fludarabine|Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
12037395|NCT00305682|Drug|mycophenolate mofetil|Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
12037396|NCT00305682|Procedure|umbilical cord blood transplantation|One or 2 UCB units may be infused to achieve the required cell dose.
12037397|NCT00305682|Radiation|total body irradiation|Administered Day -1, 200 cGy
12037398|NCT00305682|Drug|Sirolimus|Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
12037399|NCT00305669|Biological|sargramostim|
12037400|NCT00305669|Other|immunohistochemistry staining method|
12037401|NCT00305669|Other|immunological diagnostic method|
12037402|NCT00305669|Other|laboratory biomarker analysis|
12037403|NCT00305669|Procedure|conventional surgery|
12037404|NCT00305669|Procedure|neoadjuvant therapy|
12037405|NCT00305656|Drug|cediranib maleate|Given orally
12037406|NCT00305643|Drug|Capecitabine|Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.
12037407|NCT00305643|Drug|Celecoxib|200 mg given orally twice a day for each 21 day cycle.
12037408|NCT00305643|Procedure|Radiation Therapy|Some patients may undergo radiation therapy 5 days a week for 5-6 weeks, and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine once daily on days 1-14.
12037409|NCT00305643|Drug|Placebo|Oral placebo twice daily on days 1-21
12037410|NCT00305630|Drug|Periocular injection of triamcinolone acetonide 40mg|
12037411|NCT00305617|Other|antitumor drug screening assay|
12037412|NCT00305604|Drug|sitagliptin phosphate|Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.
12037413|NCT00305604|Drug|Comparator: Placebo|sitagliptin matching placebo for up to a 24-wk treatment period.
12037414|NCT00305591|Drug|l-ornithine l-aspartate|
12037415|NCT00305578|Drug|Memantine|Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.
12037645|NCT00303758|Drug|cisplatin|
12037416|NCT00305578|Drug|Placebo|No active medication, only placebo
12037417|NCT00305565|Device|VNS Therapy|Received output current of 0.25 milliamps (mA)
12037418|NCT00305565|Device|VNS Therapy|Received output current of 0.5-1.0 mA
12037419|NCT00305565|Device|VNS Therapy|Received output current of 1.0-1.5 mA
12037420|NCT00305552|Drug|THALIDOMIDE|THALIDOMIDE
12037421|NCT00305539|Drug|adalimumab|40 mg sc / for 3 months
12037422|NCT00305539|Drug|placebo|placebo
12037423|NCT00305526|Device|Contak Renewal (CRT-D)|
12037424|NCT00305513|Procedure|The phasic alerting treatment|
12037425|NCT00305500|Drug|escitalopram|
12037426|NCT00305487|Drug|Ciclesonide nasal spray|
12037427|NCT00305474|Drug|Risperidone|Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
12037428|NCT00305461|Drug|Ciclesonide|Effect of Ciclesonide on Quality of Life
12037429|NCT00305448|Drug|Fulvestrant|250 intramuscular injection
12037430|NCT00305448|Drug|Fulvestrant|500 mg intramuscular injection
12037431|NCT00305435|Drug|Romiplostim (AMG-531)|Romiplostim (AMG-531)
12037432|NCT00305422|Drug|Quetiapine fumarate|
12037433|NCT00305422|Drug|Risperidone|
12037434|NCT00305409|Drug|Synbiotic (Synergy I / B.longum)|
12037435|NCT00305396|Drug|Sirolimus|
12037436|NCT00305383|Drug|Viramidine|
12037437|NCT00305383|Drug|Peginterferon alfa-2b|
12037438|NCT00305370|Drug|Aripiprazole|
12037439|NCT00305344|Procedure|Autologous Umbilical Cord Blood Transfusion|Cord Blood infusion
12037440|NCT00305344|Biological|Cord blood|Develop Cord blood vaccine
12037441|NCT00305331|Drug|Domperidone (drug)|
12037442|NCT00305292|Drug|Modafinil-Alcohol Interactions|
12037443|NCT00305279|Other|Dietary|Dietary
12037444|NCT00305279|Other|Dietary|Dietary
12037445|NCT00305279|Other|Dietary|Dietary
12037446|NCT00305266|Drug|intravenous gammaglobulin|individual dose
12037447|NCT00305253|Device|Non-pneumatic Anti-shock Garment (NASG)|In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria.
12037448|NCT00305240|Procedure|T Wave Alternans Test|
12037449|NCT00305227|Drug|Lactin-V|
12037450|NCT00305227|Drug|Placebo|
12037451|NCT00305214|Procedure|T Wave Alternans Test|
12037452|NCT00305201|Drug|pravastatin|
12037453|NCT00305188|Drug|Xaliproden (SR57746A)|oral administration
12037454|NCT00305188|Drug|Placebo|oral administration
12037455|NCT00305188|Drug|Oxaliplatin|IV administration
12037456|NCT00305188|Drug|5-Fluorouracil|IV administration
12037457|NCT00305188|Drug|Leucovorin|IV administration
12037458|NCT00305162|Drug|Cangrelor (P2Y12 inhibitor)|IV bolus (30 mcg/kg) & infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion).
12037459|NCT00305162|Drug|clopidogrel (oral P2Y12 inhibitor)|600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access.
12037460|NCT00305162|Drug|Placebo bolus & placebo infusion|placebo bolus (30 mcg/kg) & placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
12037461|NCT00305162|Drug|Placebo capsules - end of infusion|Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
12037462|NCT00305162|Drug|Placebo capsules - as soon as possible after randomization|Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing
12037463|NCT00305149|Procedure|interim therapy scintigraphy study gallium scan or PET/CT|
12037464|NCT00305149|Procedure|"interim gallium or PET/CT"|
12037465|NCT00305110|Drug|2 mg IV hydromorphone|
12037466|NCT00305097|Dietary Supplement|Decaffeinated coffee|5 cups per day for 8 weeks
12037467|NCT00305097|Dietary Supplement|Caffeinated coffee|5 cups per day for 8 weeks
12037468|NCT00305097|Dietary Supplement|No coffee|
12037469|NCT00305084|Drug|NGR-hTNF|0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute intravenous infusion every 3 weeks
12037470|NCT00305084|Drug|Doxorubicin|75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
12037471|NCT00305071|Drug|compound cranberry extract tablet|
12037472|NCT00305058|Drug|Morphine|0.05 mg/kg Intravenous
12037473|NCT00305058|Drug|Hydromorphone|0.0075 mg/kg intravenous
12037474|NCT00305045|Device|Repetitive Transcranial Magnetic Stimulation|Magnetic pulses to specified brain structures.
12037475|NCT00305032|Procedure|gastric balloon insertion|patient would be offered endoscopic gastric balloon insertion
12037476|NCT00305019|Drug|clevudine|
12037477|NCT00305006|Procedure|Constraint-Induced Movement Therapy|90 hours
12037478|NCT00305006|Procedure|Hand-Arm Bimanual Intensive Therapy (HABIT)|90 hours
12037479|NCT00304993|Drug|fenofibrate|
12037480|NCT00304993|Drug|niacin|
12037481|NCT00304993|Drug|rosiglitazone|
12037482|NCT00304980|Drug|ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE|
12037483|NCT00304954|Drug|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
12037484|NCT00304954|Drug|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
12037485|NCT00304954|Other|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
12037486|NCT00304954|Drug|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
12037487|NCT00304915|Behavioral|Collaborative Care Interventions|Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
12037488|NCT00304863|Drug|Lactobacillus GG|This arm will receive the additional probiotic of lactobacillus GG
12037489|NCT00304850|Behavioral|polyamine-free diet|Polyamine-free diet in the 7 days befor surgery
12037490|NCT00304850|Drug|Ketamine or placebo|Peroperative and post operative (48h) ketamine injection
12037491|NCT00304837|Genetic|pVGI.1 (VEGF-2)|
12037492|NCT00304811|Drug|Vancomycin|
12037493|NCT00304811|Drug|Vancomycin plus Gentamicin|
12037494|NCT00304811|Drug|Vancomycin plus Rifampin|
12037495|NCT00304811|Drug|Vancomycin plus Gentamicin plus Rifampin|
12037496|NCT00304798|Behavioral|Hospital admission|
12037497|NCT00304785|Drug|latanoprost 0.005%|
12037498|NCT00304785|Drug|Fotil|
12037499|NCT00304785|Drug|placebo|
12037500|NCT00304772|Drug|Fluconazole|400mg/day
12037501|NCT00304772|Drug|Micafungin|150mg/day
12037502|NCT00304759|Procedure|7800 cGy/39 fractions in 8 weeks|see above
12037503|NCT00304759|Procedure|6000 cGy/20 fractions in 4 weeks|see above
12037504|NCT00304746|Drug|Testosterone gel|AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
12037505|NCT00304746|Drug|Placebo|Placebo
12037506|NCT00304733|Device|cast vs. shoe|
12037507|NCT00304720|Drug|Tacrolimus and MMF|
12037508|NCT00304707|Drug|Bupropion|300 mg QD
12037509|NCT00304707|Drug|placebo|placebo
12037510|NCT00304681|Drug|OROS*-Methylphenidate|
12037511|NCT00304668|Drug|dapivirine (TMC120) vaginal gel|
12037512|NCT00304655|Drug|Aripiprazole|
12037513|NCT00304642|Drug|dapivirine (TMC120) vaginal gel|
12037514|NCT00304629|Drug|galantamine|
12037515|NCT00304616|Drug|Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone|
12037516|NCT00304603|Other|No intervention|No treatment was given to the patients as this is an observational study.
12037517|NCT00304590|Drug|XL999|Treatment consisted of 8 weekly infusions of 2.4 mg/kg of XL999 with each infusion given over 4 hours, unless drug-related toxicity required a dosing delay or adjustment. In the absence of progressive disease and unacceptable toxicity, subjects may have received XL999 treatment weekly for up to 1 year on this study.
12037518|NCT00304577|Procedure|Bilateral recession|
12037519|NCT00304577|Procedure|Unilateral recession and resection|
12037520|NCT00304564|Behavioral|Music Listening|subjects listen to music
12037521|NCT00304551|Drug|peginterferon alfa-2a 180μg|180μg（s.c.）/week for 48 weeks
12037522|NCT00304551|Drug|peginterferon alfa-2a 90μg|90μg(s.c.)/week for 48 weeks
12037523|NCT00304551|Drug|ribavirin|600, 800, or 1,000 mg X 2(p.o.)/day
12037524|NCT00304538|Drug|very low dose (VLD) glucagon|
12037525|NCT00304525|Drug|RAF265|A liquid nonaqueous oral formulation. Switched to a tablet formulations with was 60% bioavailable, relative to the liquid at 50mg dose. The liquid dose will be multiplied by a factor of 1.67 to achieve a comparable tablet dose. Tablets are available in 10mg and 50mg strengths.
12037526|NCT00304512|Drug|migalastat HCl|
12037527|NCT00304499|Drug|Oxybutynin|
12037528|NCT00304473|Drug|Quetiapine fumarate|
12037529|NCT00304460|Biological|aldesleukin|
12037530|NCT00304447|Drug|Mylotarg|
12037531|NCT00304434|Drug|Oseltamivir|
12037532|NCT00304434|Drug|Probenecid|
12037533|NCT00304421|Drug|rabeprazole|
12037534|NCT00304421|Drug|pantoprazole|
12037535|NCT00304382|Biological|Prevnar|0.5 ml IM into each deltoid muscle one time (or two in group PCV-PCV)
12037536|NCT00304382|Biological|Pneumovax|0.5 ml IM one time
12037537|NCT00304369|Drug|Metronidazole|
12037538|NCT00304356|Drug|Nitazoxanide|500 mg bid
12037539|NCT00304317|Drug|celecoxib|Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
12037540|NCT00304317|Other|Placebo|Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.
12037541|NCT00304304|Behavioral|Asthma education|Research assistant worked with CCC staff on asthma prevention
12037542|NCT00304291|Drug|Mitoxantrone|
12037543|NCT00304278|Drug|Erlotinib (Tarceva)|150 mg daily X 7 weeks
12037544|NCT00304278|Drug|Intra-arterial Cisplatin (PLAT)|1 dose (150 mg/sq) per week X 4 weeks
12037545|NCT00304278|Radiation|Radiation Therapy (RAD)|5 days per week X 7 weeks
12037546|NCT00304265|Biological|COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)|0.5 mL, Intramuscular
12037547|NCT00304252|Drug|Interferon beta-1a|
12037548|NCT00304239|Procedure|Photodynamic therapy with methyl aminolevulinate cream|
12037549|NCT00304226|Drug|valsartan|
12037550|NCT00304226|Drug|amlodipine|
12037551|NCT00304213|Drug|Testosterone|
12037552|NCT00304200|Drug|Temozolomide and SU11248|First Cohort: Temozolomide 100 mg/m2 orally week 1 and week 3 of a 28-day cycle; SU11248, 25 mg/day orally on weeks 2, 3, and 4 or a 28 day cycle.
12037553|NCT00304187|Drug|Erythromycin|Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
12037554|NCT00304187|Drug|Placebo|Placebo, 250 mg or 500 mg, three times a day for 6 weeks
12037555|NCT00304174|Behavioral|Motivation to eat|Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.
12037556|NCT00304161|Drug|Atomoxetine|40 to 80 mg orally once daily for 8 weeks
12037557|NCT00304161|Drug|Placebo|40 to 80 mg orally once daily for 8 weeks
12037558|NCT00304135|Drug|cisplatin|
12037559|NCT00304135|Drug|gemcitabine hydrochloride|
12037560|NCT00304135|Drug|oxaliplatin|
12037561|NCT00304096|Biological|synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine|
12037562|NCT00304083|Biological|filgrastim|Given subcutaneously
12037563|NCT00304083|Drug|doxorubicin hydrochloride|Given IV
12037564|NCT00304083|Drug|etoposide|Given IV
12037565|NCT00304083|Drug|ifosfamide|Given IV
12037566|NCT00304083|Procedure|conventional surgery|Patients undergo surgery
12037567|NCT00304083|Radiation|radiation therapy|Patients undergo radiotherapy
12037568|NCT00304070|Drug|doxorubicin hydrochloride|Given IV
12037569|NCT00304070|Procedure|conventional surgery|Patients undergo surgery
12037570|NCT00304070|Drug|cisplatin|Given IV
12037571|NCT00304070|Drug|mitotane|Given orally
12037572|NCT00304070|Drug|etoposide|Given IV
12037573|NCT00304070|Biological|filgrastim|Given subcutaneously
12037574|NCT00304031|Drug|Concurrent temozolomide|Daily oral temozolomide (75 mg/m2) up to 49 doses.
12037575|NCT00304031|Radiation|Concurrent radiation therapy|60 Gy in 2 Gy fractions
12037576|NCT00304031|Drug|100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle|Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
12037577|NCT00304031|Drug|75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle|Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
12037578|NCT00304018|Biological|anti-thymocyte globulin|
12037579|NCT00304018|Biological|sargramostim|
12037580|NCT00304018|Drug|busulfan|
12037581|NCT00304018|Drug|etoposide|
12037582|NCT00304018|Drug|fludarabine phosphate|
12037583|NCT00304018|Drug|prednisone|
12037584|NCT00304018|Drug|tacrolimus|
12037585|NCT00304018|Procedure|allogeneic hematopoietic stem cell transplantation|
12037586|NCT00304018|Procedure|umbilical cord blood transplantation|
12037587|NCT00304005|Drug|laromustine|
12037588|NCT00303992|Biological|trastuzumab|
12037589|NCT00303992|Drug|irinotecan hydrochloride|
12037590|NCT00303966|Drug|sorafenib tosylate|Given orally
12037591|NCT00303953|Drug|belinostat|Given IV
12037592|NCT00303940|Drug|carboplatin|
12037593|NCT00303940|Drug|talabostat mesylate|
12037594|NCT00303940|Drug|temozolomide|
12037595|NCT00303940|Other|pharmacological study|
12037596|NCT00303927|Drug|capecitabine|
12037597|NCT00303914|Procedure|assessment of therapy complications|
12037598|NCT00303914|Procedure|cognitive assessment|
12037599|NCT00303914|Procedure|psychosocial assessment and care|
12037600|NCT00303901|Procedure|cryosurgery|
12037601|NCT00303901|Procedure|positron emission tomography|
12037602|NCT00303888|Drug|docetaxel|Given IV
12037603|NCT00303888|Drug|idronoxil|Given orally
12037604|NCT00303888|Other|placebo|Given orally
12037605|NCT00303875|Behavioral|behavioral dietary and exercise intervention|
12037606|NCT00303862|Drug|cediranib maleate|Given orally
12037607|NCT00303862|Other|laboratory biomarker analysis|Correlative studies
12037608|NCT00303849|Drug|Carboplatin|Given IA
12037609|NCT00303849|Drug|Etoposide|Given IV
12037610|NCT00303849|Drug|Etoposide Phosphate|Given IV
12037611|NCT00303849|Other|Laboratory Biomarker Analysis|Correlative studies
12037612|NCT00303849|Drug|Mannitol|Given IA
12037613|NCT00303849|Drug|Melphalan|Given IA
12037614|NCT00303849|Other|Quality-of-Life Assessment|Ancillary studies
12037615|NCT00303849|Drug|Sodium Thiosulfate|Given IV
12037616|NCT00303836|Drug|cyclophosphamide|Given IV
12037617|NCT00303836|Drug|fludarabine phosphate|Given IV
12037618|NCT00303836|Biological|therapeutic autologous lymphocytes|Given IV
12037619|NCT00303836|Procedure|in vitro-treated peripheral blood stem cell transplantation|Undergo in vitro-treated peripheral blood stem cell transplantation
12037620|NCT00303836|Biological|gp100 antigen|Given SC
12037621|NCT00303836|Biological|MART-1 antigen|Given SC
12037622|NCT00303836|Biological|incomplete Freund's adjuvant|Given SC
12037623|NCT00303836|Biological|filgrastim|Given SC
12037624|NCT00303836|Biological|aldesleukin|Given IV
12037625|NCT00303823|Drug|placebo|Given orally
12037626|NCT00303823|Dietary Supplement|defined green tea catechin extract|Given orally
12037627|NCT00303823|Other|laboratory biomarker analysis|Correlative studies
12037628|NCT00303810|Drug|carboplatin|
12037629|NCT00303810|Drug|cisplatin|
12037630|NCT00303810|Drug|cyclophosphamide|
12037631|NCT00303810|Drug|etoposide phosphate|
12037632|NCT00303810|Drug|high-dose chemotherapy|
12037633|NCT00303810|Drug|lomustine|
12037634|NCT00303810|Drug|methotrexate|
12037635|NCT00303810|Drug|thiotepa|
12037636|NCT00303810|Drug|vincristine sulfate|
12037637|NCT00303810|Radiation|radiation therapy|
12037638|NCT00303797|Drug|17-N-allylamino-17-demethoxygeldanamycin/bortezomib|
12037639|NCT00303797|Drug|sorafenib tosylate|
12037640|NCT00303784|Drug|Goserelin|3.6mg implant, in pre-filled syringe
12037641|NCT00303784|Drug|Estradiol|Each patch contains 3 mg of estradiol hemihydrate in a patch size of 30 cm2, releasing 100 micrograms of estradiol per 24 hours.
12037642|NCT00303771|Drug|fluorouracil|
12037643|NCT00303771|Drug|irinotecan hydrochloride|
12037647|NCT00303758|Drug|gemcitabine hydrochloride|
12037648|NCT00303758|Drug|leucovorin calcium|
12037649|NCT00303745|Drug|capecitabine|
12037650|NCT00303745|Drug|irinotecan hydrochloride|
12037651|NCT00303732|Drug|RAD001 (everolimus)|
12037652|NCT00303732|Drug|PTK787 (vatalanib)|
12037653|NCT00303719|Biological|anti-thymocyte globulin|"ATG dose is 15 mg/kg intravenous (IV) every 12 hours for 6 doses on days -6, -5, and -4.
~Those that should/will receive ATG in the preparative regimen:
~Related donor recipients who have not had exposure to combination chemotherapy in the 6 months preceding transplant should
~Unrelated donor recipients who have not had exposure to combination chemotherapy in the 3 months preceding transplant will
~Unrelated donor recipients who have had only a single induction cycle for the treatment of ALL/AML or MDS or CML blast crisis should
~Recipients with a prior autologous transplant in the year prior to second transplant do not require ATG."
12037654|NCT00303719|Drug|cyclophosphamide|Cyclophosphamide will be given in a two hour infusion, total dose 50 mg/kg on day -6.
12037655|NCT00303719|Drug|cyclosporine|Patients will receive cyclosporine A (CSA) therapy beginning on day -3 maintaining a level of >200. For adults the initial dose will be 2.5 mg/kg IV over 2 hours every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours. Patients will receive CSA until day +100.
12037656|NCT00303719|Drug|fludarabine|Fludarabine 30 mg/m^2/day intravenous (IV) on day -6 through day -2., total dose 150 mg/m^2 for 5 days.
12037657|NCT00303719|Drug|mycophenolate mofetil|Mycophenolate mofetil (MMF) 1.5 gram twice a day (BID) or if < 50 kg will be given 15 mg/kg orally(po) BID,beginning on day -3, and discontinue at day +30 or 7 days after engraftment (3 consecutive days of absolute neutrophil count (ANC) > 0.5 x 109 /L).
12037658|NCT00303719|Procedure|stem cell transplantation|On day 0, if related donor, stem cells are infused via central line. If unrelated donor, marrow/PBSC is infused after arrival and processing on day 0.
12037659|NCT00303719|Radiation|total body irradiation|The dose of TBI will be 200 cGy given in a single fraction on day -1.
12037660|NCT00303719|Drug|filgrastim|Patients with white blood cell (WBC) counts < 2500 any time after stem cell infusion will be started on G-CSF support at Day +5 at a dose of 5 mcg/kg intravenously or subcutaneously (IV/SQ) daily rounded to vial size until absolute neutrophil count (ANC) > 2500 for 2 consecutive days.
12037661|NCT00303706|Procedure|Endoscopic Radial Artery Harvest|
12037662|NCT00303667|Biological|aldesleukin|Administered subcutaneously (SQ) 9 million units every other day beginning Day -12 through -2 (evening of natural killer cell infusion) for a total of 6 doses.
12037663|NCT00303667|Biological|natural killer cells|Infusion given on Day -12; The targeted infused cell dose of CD3- CD19- selected NK product is within the range of 2-3 x 10^7 cells/kg.
12037664|NCT00303667|Drug|cyclophosphamide|Administered intravenously (IV) 50 mg/kg on Day -15
12037665|NCT00303667|Drug|fludarabine phosphate|Administered intravenously (IV) 40 mg/m^2 on Days -18 through -14
12037666|NCT00303667|Procedure|allogeneic hematopoietic stem cell transplantation|On day 0, patients will receive an allogeneic transplant using pool cells from the day -1 and day 0 PBSC which will be CD34+ selected as the donor graft. The graft will be infused over 15-60 minutes.
12037667|NCT00303667|Radiation|total body irradiation|Administered on Day -13, 200 cGy two times.
12037668|NCT00303667|Biological|Thymoglobulin|intravenous (IV) 3 mg/kg on Day 0 (day of donor CD34 cell infusion)
12037669|NCT00303667|Drug|Cyclosporin A|1.5 mg/kg by mouth or intravenously for target dose range of 150-250; day -15 through day -8.
12037670|NCT00303667|Drug|cyclophosphamide|Administered intravenously (IV) 50 mg/kg on Days -16 and -15
12037671|NCT00303667|Drug|fludarabine phosphate|Administered intravenously (IV) 35 mg/m^2 on Days -18 through -14
12037672|NCT00303654|Procedure|biopsy|
12037673|NCT00303654|Procedure|therapeutic conventional surgery|
12037674|NCT00303641|Device|Medtronic Resting Heart Bypass System|
12037675|NCT00303628|Drug|oxaliplatin|Given IV
12037676|NCT00303628|Drug|fluorouracil|Given IV
12037677|NCT00303628|Drug|leucovorin calcium|Given IV
12037678|NCT00303628|Drug|bevacizumab|Given IV
12037679|NCT00303615|Drug|Fluoxymesterone 10 mg|
12037680|NCT00303615|Drug|Anastrozole 1 mg|
12037681|NCT00303602|Drug|Sublingual orally disintegrating olanzapine (SODO)|5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.
12037682|NCT00303602|Drug|Oral olanzapine|5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
12037683|NCT00303589|Drug|Standard care|As prescribed
12037684|NCT00303589|Drug|beta-lactam|750mg iv q8h
12037685|NCT00303589|Drug|beta-lactam|1500mg iv q8h
12037686|NCT00303576|Drug|dapivirine (TMC120) vaginal gel|
12037687|NCT00303563|Drug|P38 Inhibitor (4)|50mg po qd
12037688|NCT00303563|Drug|P38 Inhibitor (4)|150mg po qd
12037689|NCT00303563|Drug|P38 Inhibitor (4)|300mg po qd
12037690|NCT00303563|Drug|Placebo|po qd
12037691|NCT00303550|Drug|Intravenous iclaprim|
12037692|NCT00303550|Drug|Intravenous linezolid|
12037693|NCT00303537|Drug|metformin|
12037694|NCT00303524|Drug|Goserelin acetate|Injection 3.6 mg monthly
12037695|NCT00303524|Drug|Goserelin acetate|injection 10.8 mg every 3 months
12037696|NCT00303498|Drug|Sitaxsentan sodium|sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months
12037697|NCT00303498|Drug|Placebo|placebo identical to the study drug in description, dose and duration
12037698|NCT00303485|Drug|Placebo|po monthly for 6 months
12037699|NCT00303485|Drug|Vitamin D and calcium supplementation|As prescribed
12037700|NCT00303485|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months
12037701|NCT00303472|Drug|Romiplostim|
12037702|NCT00303459|Drug|bosentan|bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.
12037703|NCT00303459|Drug|placebo|Matching bosentan placebo/b.i.d.
12037704|NCT00303446|Drug|Dutasteride|Dutasteride 0.5 mg/day
12037705|NCT00303446|Drug|Placebo|Matched placebo
12037706|NCT00303433|Drug|Namenda|
12037707|NCT00303420|Drug|"Alteplase push protocol"|alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate.
12037708|NCT00303420|Drug|alteplase dwell arm|alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary
12037709|NCT00303407|Drug|nadroparin|
12037710|NCT00303394|Drug|IL-1Ra|
12037711|NCT00303381|Drug|Interferon-beta-1a, 44 microgram|Interferon-beta-1a will be administered subcutaneously at a dose of 44 mcg, three times a week up to Week 8.
12037712|NCT00303381|Drug|Placebo|Matching Placebo will be administered subcutaneously, three times a week up to Week 8.
12037713|NCT00303381|Drug|Interferon-beta-1a, 66 microgram|Interferon-beta-1a will be administered subcutaneously at a dose of 66 mcg, three times a week up to Week 8.
12037714|NCT00303342|Behavioral|mind body treatment|regulation of attention, respiration and posture
12037715|NCT00303342|Behavioral|desensitization|mentation on insomnia behaviors and cognitive activity
12037716|NCT00303329|Drug|Deferasirox|Deferasirox available as 125 mg, 250 mg or 500 mg tablets
12037717|NCT00303316|Biological|DTaP-IPV//PRP~T combined vaccine|0.5 mL, Intramuscular
12037718|NCT00303316|Biological|DTaP-IPV//PRP~T combined vaccine|0.5 mL, Intramuscular
12037719|NCT00303303|Biological|Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy)|Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; active maintenance therapy with 2 vials administered 6, 12, and 18 hours after initial control is achieved.
12037720|NCT00303303|Biological|Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy)|Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; placebo maintenance therapy administered 6, 12, and 18 hours after initial control is achieved.
12037721|NCT00303303|Biological|Placebo|Placebo therapy in place of initial and maintenance antivenom therapy. Note that open-label rescue therapy is mandated if the envenomation syndrome becomes severe, or if progression of envenomation signs/symptoms has not spontaneously halted by 6 hours.
12037722|NCT00303290|Drug|Peg Interferon Alpha 2b (Peg Intron)|4.5 micrograms/kg once a week
12037723|NCT00303290|Drug|Ara-C (cytosine arabinoside)|10 mg under the skin daily
12037724|NCT00303277|Drug|simvastatin|simvastatin 40 mg tablets once per day for 12 weeks
12037725|NCT00303277|Drug|pravastatin|pravastatin 80 mg tablets once per day for 12 weeks
12037726|NCT00303264|Drug|dexloxiglumide|
12037727|NCT00303264|Drug|Nexium (esomeprazole)|
12037728|NCT00303251|Drug|TKI258|
12037729|NCT00303238|Drug|Rose hips extract + blueberry/blackberry extract + resveravine|
12037730|NCT00303238|Drug|Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extract|
12037731|NCT00303238|Drug|Rose hips extract + resveravine + Aframomum melegueta extract|
12037732|NCT00303225|Drug|Vaccine: SIGA-246|
12037733|NCT00303212|Other|Telemonitoring|Participants in the intervention group are instructed to make a daily toll-free call to an automated telemonitoring system being provided by Pharos Innovations® (Chicago, IL) for 6 months.On each call patients hear a pre-recorded voice that goes through a series of questions about symptoms and the patient's daily weight. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians at each practice site.
12037734|NCT00303199|Drug|ZIO-101 (Darinaparsin)|IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months
12037735|NCT00303173|Behavioral|Guided Imagery|
12037736|NCT00303160|Drug|vitamin C & E supplements|
12037737|NCT00303147|Behavioral|Expressive Writing|
12037738|NCT00303134|Drug|Islet Cell Transplantation|Islet Cell Transplantation for patients with type 1 diabetes mellitus
12037739|NCT00303108|Drug|Pegylated liposomal doxorubicin|30 mg/m2 IV on Day 1 of each 28 day cycle
12037740|NCT00303108|Drug|Carboplatin|AUC=5 on Day 1 of each 28 day cycle
12037741|NCT00303108|Drug|trastuzumab|4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)
12037742|NCT00303082|Drug|Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14|
12037743|NCT00303069|Biological|V710|Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly
12037744|NCT00303069|Biological|Comparator: Placebo|Single dose of saline placebo intramuscularly
12037745|NCT00303056|Drug|HOE140 Icatibant|
12037746|NCT00303043|Procedure|Mixed venous saturation monitoring|Mixed venous saturation monitoring
12037747|NCT00303030|Procedure|1. Anal injection|Submucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere.
12037748|NCT00303030|Procedure|2. Biofeedback|Training under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe.
12037749|NCT00303017|Dietary Supplement|flavocoxid|flavonoid mixture
12037750|NCT00303017|Drug|Naproxen|non-steroidal anti-inflammatory drug
12037751|NCT00303004|Drug|Bosentan and Sildenafil|
12037752|NCT00302978|Behavioral|Behavior therapy|
12037753|NCT00302965|Drug|Frozen Plasma|
12037754|NCT00302952|Drug|Lovastatin|Two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion
12037755|NCT00302952|Drug|Placebo|Two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion
12037756|NCT00302926|Procedure|energy restriction and maintenance|
12037757|NCT00302913|Drug|Adjustment of clopidogrel dose|
12037758|NCT00302900|Behavioral|Pre-Donation Water Consumption|Consumption of 500 ml of bottled water 30 minutes prior to donating
12037759|NCT00302900|Behavioral|Muscle Tensing Exercise During Donation|Alternating leg lifts at 10-second intervals during donation
12037760|NCT00302900|Behavioral|Muscle Tensing Exercise Prior to Donation|Alternating leg lifts at 10-second intervals prior to insertion of the donation needle
12037761|NCT00302887|Device|combined ultrasound therapy|
12037762|NCT00302887|Procedure|connective tissue manipulation|
12037763|NCT00302874|Behavioral|Implementation of a protocol for treatment of hyperglycemia|
12037764|NCT00302861|Biological|MyVax|
12037765|NCT00302848|Drug|Drospirenone|
12037766|NCT00302848|Drug|Levonorgestrel|
12037767|NCT00302848|Drug|Other progestin containing oral contraceptive|
12037768|NCT00302835|Drug|non-phenacetin containing analgesics|
12037769|NCT00302822|Drug|enfuvirtide|from week 0 to 24
12037770|NCT00302822|Drug|emtricitabine/tenofovir|1 pill/day
12037771|NCT00302822|Drug|lopinavir or efavirenz|investigator choice
12037772|NCT00302809|Dietary Supplement|Concord Grape Juice|Approximately 16 oz of grape juice or placebo
12037773|NCT00302796|Drug|Bioclavid|500 + 125 mg times 3 or 6
12037774|NCT00302796|Drug|Placebo|
12037775|NCT00302783|Behavioral|Multi-Source Feedback: including self-assessment & coaching|
12037776|NCT00302770|Drug|quetiapine|
12037777|NCT00302757|Drug|Radioimmunotherapy|
12037778|NCT00302757|Procedure|allogeneic hematopoietic cell transplantation|
12037779|NCT00302744|Drug|Psilocybin (drug)|One placebo session (niacin) and one active drug session (.2 mg/kg). Treatment sessions are six hours.
12037780|NCT00302731|Drug|Estradiol , estriol , progesterone|
12037781|NCT00302731|Drug|estradiol, progesterone|
12037782|NCT00302731|Drug|estriol, progesterone|
12037783|NCT00302731|Drug|equine estrogens m-progesteroneacetate|
12037784|NCT00302718|Behavioral|Physician-level financial incentives|Enrolled physician participants are eligible to receive financial incentives and audit and feedback reports based on their performance during a 4-month interval on the hypertension care study outcomes.
12037785|NCT00302718|Behavioral|Practice-level financial incentives|Enrolled practices (physician physicians and non-physician primary care personnel) are eligible to receive financial incentives and audit and feedback reports based on the performance of the practice during a 4-month interval on the hypertension care study outcomes.
12037786|NCT00302718|Behavioral|Physician- and practice-level financial incentives|Enrolled participants are eligible to receive financial incentives and audit and feedback reports based on performance during a 4-month interval on the hypertension care study outcomes. This arm tests the effect of combined financial incentives (physician-level incentives and practice-level incentives).
12037787|NCT00302705|Drug|Valsartan, Enalapril|160 mg valsartan versus 10-20 mg enalapril
12037788|NCT00302705|Device|Ambulatory blood pressure monitoring|Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
12037789|NCT00302705|Procedure|Missing one dose|Patients skip the dose the second day of monitoring
12037790|NCT00302692|Drug|Esmolol|
12037791|NCT00302692|Drug|Metoprolol|
12037792|NCT00302666|Drug|Valette (Dienogest/EE30, BAY86-5038)|Oral contraceptive extended cycles
12037793|NCT00302666|Drug|Valette (Dienogest/EE30, BAY86-5038)|Oral contraceptive conventional cycles
12037794|NCT00302653|Drug|Rasburicase|Rasburicase 0,20mg/Kg/Day once a day 3-7 days
12037795|NCT00302640|Drug|Alinia (nitazoxanide)|
12037796|NCT00302627|Drug|Pamidronate|60mg or 90mg given at baseline, 6,12,18, and 24 months
12037797|NCT00302627|Drug|vitamin D|baseline, 6,12 months
12037798|NCT00302627|Drug|Calcium Carbonate|baseline, 6,12 months
12037799|NCT00302601|Procedure|Scintigraphic interpretation|Not relevant
12037800|NCT00302575|Behavioral|Collaborative Behavioral Management|
12037801|NCT00302575|Procedure|Integrated parole and outpatient addiction treatment|
12037802|NCT00302549|Drug|FK506|FK506,0.1mg/kg/d
12037803|NCT00302536|Drug|Tacrolimus|Tacrolimus
12037804|NCT00302523|Drug|Tacrolimus|FK506,0.1mg/kg/d
12037805|NCT00302510|Procedure|immunoadsorption|immunoadsorption
12037806|NCT00302497|Drug|basiliximab|
12037807|NCT00302484|Drug|Zoledronate|
12037808|NCT00302471|Drug|Comparator: MK0429|"Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone.
~Disease."
12037809|NCT00302471|Drug|Comparator: MK0429|Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
12037810|NCT00302471|Drug|Comparator: MK0429|Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
12037811|NCT00302471|Drug|Comparator: MK0429|Part 2 - MK3328 of 400 mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
12037812|NCT00302458|Drug|OROS-Methylphenidate|Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules
12037813|NCT00302458|Drug|Immediate Release Methylphenidate|Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules
12037814|NCT00302458|Drug|Placebo|Placebo will be administered during the first part of the day, and again during the second part of the day.
12037815|NCT00302445|Drug|Efalizumab|
12037816|NCT00302445|Device|Narrow Band Phototherapy|
12037817|NCT00302432|Behavioral|Behavior therapy, cigarette holders, Flowers Menthol|
12037818|NCT00302419|Drug|intracoronary infusion,|streptokinase, 250,000 units
12037819|NCT00302419|Procedure|primary percutaneous coronary angioplasty|
12037820|NCT00302406|Drug|methylphenidate hydrochloride|
12037821|NCT00302406|Drug|OROS methylphenidate hydrochloride (CONCERTA)|
12037822|NCT00302393|Drug|OROS methylphenidate hydrochloride|Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of OROS MPH will be 36 mg which will be supplied as one 36 mg capsules. Study treatments will be administered with water following an overnight fast of at least 8 hours.
12037823|NCT00302393|Drug|methylphenidate hydrochloride|Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of IR MPH will be 20 mg which will be supplied as one 20 mg capsule. Study treatments will be administered with water following an overnight fast of at least 8 hours.
12037824|NCT00302380|Radiation|PET imaging using C-11 altropane as the ligand.|A one-injection protocol will be used for the study. C-11 Altropane will be injected manually as an intravenous bolus.
12037825|NCT00302367|Drug|OROS methylphenidate hydrochloride|
12037826|NCT00302367|Drug|immediate release methylphenidate hydrochloride|
12037827|NCT00302354|Drug|OROS methylphenidate HCl|
12037828|NCT00302354|Drug|SODAS methylphenidate HCl|
12037829|NCT00302341|Drug|Pafuramidine maleate (DB289)|Oral tablet, 100 mg bid, 14 days
12037830|NCT00302341|Drug|Trimethoprim-Sulfamethoxazole (TMP-SMX)|15 mg/kg, oral tablet split tid X 21 days
12037831|NCT00302328|Procedure|macular hole operation|macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
12037832|NCT00302315|Device|transcutaneous electrical nerve stimulation|
12037833|NCT00302302|Drug|L-arabinose|
12037834|NCT00302289|Drug|tyrosine, green tea, caffeine|
12037835|NCT00302276|Drug|Metobes-compound|
12037836|NCT00302263|Drug|Metobes-compound|
12037837|NCT00302250|Drug|ALT-711 (alagebrium chloride)|
12037838|NCT00302237|Device|RX ACCULINK, RX ACCUNET Embolic Protection System|1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.
12037839|NCT00302224|Drug|2S, 4R Ketoconazole (DIO-902)|
12037840|NCT00302211|Drug|Inhaled Iloprost (5 μg)|iloprost inhalation solution (Ventavis) (5 μg)
12037841|NCT00302211|Drug|Inhaled Placebo|inhaled placebo
12037842|NCT00302211|Drug|Sildenafil|oral sildenafil (dosage between 60 and 300 mg/day)
12037843|NCT00302211|Drug|Bosentan|oral bosentan (dosage between 62.5 and 125 mg BID)
12037844|NCT00302198|Behavioral|ALS Registry|
12037845|NCT00302185|Procedure|Acupuncture|Insertion of sterile, single-use acupuncture needles at 10-20 points including PC.6, HT.7, St.36, SP.6, and LR.3. Needles were connected to an electrical stimulator to mimick traditional manual stimulation with alternating patterns of stimulation for 20 minutes.
12037846|NCT00302185|Behavioral|Nurse-led supportive care|20-30 minutes of supportive attention from an experienced palliative nurse.
12037847|NCT00302172|Drug|ARQ 197|"Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days).
~Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks.
~All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted."
12037848|NCT00302159|Procedure|adjuvant therapy|
12037849|NCT00302159|Drug|Temozolomide|Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
12037850|NCT00302159|Drug|Valproic Acid|Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
12037851|NCT00302159|Radiation|Radiation therapy|External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
12037852|NCT00302133|Drug|Naltrexone hydrochloride|Naltrexone hydrochloride 50 mg capsule daily for 12 weeks
12037853|NCT00302133|Other|Placebo|Placebo arm
12037854|NCT00302120|Procedure|Contrast-enhanced MR mammography|
12037855|NCT00302107|Drug|Mirtazapine|Mirtazapine initiated at 15mg qhs and titrated in 15mg increments to a maximum of 45 mg qhs as tolerated.
12037856|NCT00302107|Drug|Placebo|Look-a-like placebo tablets under double-blind conditions
12037857|NCT00302081|Biological|peginterferon alfa-2b (SCH 54031)|1.5 mcg/kg QW SC for 24 weeks
12037858|NCT00302081|Biological|peginterferon alfa-2b (SCH 54031)|1.0 mcg/kg QW SC for 24 weeks
12037859|NCT00302081|Biological|peginterferon alfa-2b (SCH 54031)|1.5 mcg/kg QW SC for 16 weeks
12037860|NCT00302081|Drug|ribavirin (SCH 18908)|800-1200 mg daily for 24 weeks
12037861|NCT00302081|Drug|ribavirin (SCH 18908)|800-1200 mg daily for 16 weeks
12037862|NCT00302068|Behavioral|Supervised Aerobic Exercise|Supervised aerobic exercise, three times per week, for 16 weeks.
12037863|NCT00302068|Drug|Sertraline|Sertraline (Zoloft), daily, for 16 weeks.
12037864|NCT00302068|Drug|Placebo Pill.|Placebo pill, daily, for 16 weeks.
12037865|NCT00302055|Behavioral|Clinical referral to diabetes prevention lifestyle|16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
12037866|NCT00302055|Behavioral|Clinical referral to group diabetes prevention lifestyle|16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
12037867|NCT00302042|Behavioral|Brief counseling plus group diabetes prevention in community|Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk, Group diabetes prevention in community: 16 weekly group lifestyle behavior change visits followed by monthly group lifestyle behavior change visits.
12037868|NCT00302042|Behavioral|Brief Counseling for pre-diabetes alone|Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk.
12037869|NCT00302016|Drug|AMN107|
12037870|NCT00302003|Radiation|radiation therapy|Undergo radiation therapy
12037871|NCT00302003|Drug|doxorubicin hydrochloride|Given IV
12037872|NCT00302003|Drug|vincristine sulfate|Given IV
12037873|NCT00302003|Drug|prednisone|Given orally
12037874|NCT00302003|Drug|cyclophosphamide|Given IV
12037875|NCT00302003|Drug|ifosfamide|Given IV
12037876|NCT00302003|Drug|vinorelbine tartrate|Given IV
12037877|NCT00302003|Drug|dexamethasone|Given IV
12037878|NCT00302003|Drug|etoposide phosphate|Given IV
12037879|NCT00302003|Drug|cisplatin|Given IV
12037880|NCT00302003|Drug|cytarabine|Given IV
12037881|NCT00302003|Biological|filgrastim|Given IV or subcutaneously
12037882|NCT00301990|Biological|aldesleukin|
12037883|NCT00301990|Biological|bevacizumab|
12037884|NCT00301964|Biological|bevacizumab|Given IV
12037885|NCT00301964|Other|laboratory biomarker analysis|Correlative studies
12037886|NCT00301951|Biological|anti-thymocyte globulin|
12037887|NCT00301951|Biological|sargramostim|
12037888|NCT00301951|Drug|busulfan|
12037889|NCT00301951|Drug|fludarabine phosphate|
12037890|NCT00301951|Drug|mycophenolate mofetil|
12037891|NCT00301951|Drug|tacrolimus|
12037892|NCT00301951|Procedure|umbilical cord blood transplantation|
12037893|NCT00301938|Drug|7-hydroxystaurosporine|Given IV
12037894|NCT00301938|Drug|perifosine|Given orally
12037895|NCT00301938|Other|pharmacological study|Correlative studies
12037896|NCT00301925|Biological|pegfilgrastim|
12037897|NCT00301925|Drug|capecitabine|
12037898|NCT00301925|Drug|cyclophosphamide|
12037899|NCT00301925|Drug|epirubicin hydrochloride|
12037900|NCT00301925|Drug|fluorouracil|
12037901|NCT00301925|Drug|methotrexate|
12037902|NCT00301925|Procedure|adjuvant therapy|
12037903|NCT00301912|Biological|filgrastim|
12037904|NCT00301912|Drug|busulfan|
12037905|NCT00301912|Drug|fludarabine phosphate|
12037906|NCT00301912|Drug|methotrexate|
12037907|NCT00301912|Drug|tacrolimus|
12037908|NCT00301912|Procedure|allogeneic bone marrow transplantation|
12037909|NCT00301912|Procedure|allogeneic hematopoietic stem cell transplantation|
12037910|NCT00301912|Procedure|peripheral blood stem cell transplantation|
12037911|NCT00301899|Biological|pertuzumab|
12037912|NCT00301899|Biological|trastuzumab|
12037913|NCT00301886|Drug|ibandronate|
12037914|NCT00301886|Drug|zoledronate|
12037915|NCT00301886|Procedure|quality-of-life assessment|
12037916|NCT00301873|Drug|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
12037917|NCT00301860|Biological|anti-thymocyte globulin|
12037918|NCT00301860|Biological|filgrastim|
12037919|NCT00301860|Biological|therapeutic allogeneic lymphocytes|
12037920|NCT00301860|Drug|cyclosporine|
12037921|NCT00301860|Drug|fludarabine phosphate|
12037922|NCT00301860|Drug|melphalan|
12037923|NCT00301860|Drug|methotrexate|
12037924|NCT00301860|Procedure|allogeneic hematopoietic stem cell transplantation|
12037925|NCT00301860|Procedure|peripheral blood stem cell transplantation|
12037926|NCT00301847|Drug|sorafenib tosylate|
12037927|NCT00301834|Biological|alemtuzumab|
12037928|NCT00301834|Drug|busulfan|
12037929|NCT00301834|Drug|cyclosporine|
12037930|NCT00301834|Drug|fludarabine phosphate|
12037931|NCT00301834|Drug|methotrexate|
12037932|NCT00301834|Drug|methylprednisolone|
12037933|NCT00301834|Procedure|allogeneic bone marrow transplantation|
12037934|NCT00301834|Procedure|allogeneic hematopoietic stem cell transplantation|
12037935|NCT00301834|Procedure|peripheral blood stem cell transplantation|
12037936|NCT00301834|Procedure|umbilical cord blood transplantation|
12037937|NCT00301821|Biological|epratuzumab|
12037938|NCT00301821|Biological|rituximab|
12037939|NCT00301821|Drug|cyclophosphamide|
12037940|NCT00301821|Drug|doxorubicin hydrochloride|
12037941|NCT00301821|Drug|prednisone|
12037942|NCT00301821|Drug|vincristine sulfate|
12037943|NCT00301808|Drug|Cisplatin|Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
12037944|NCT00301808|Drug|Docetaxel|Docetaxel 75 mg/m2 on day 1 of each cycle
12037945|NCT00301808|Drug|Pemetrexed disodium|Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
12037946|NCT00301808|Radiation|Radiation therapy|Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
12037947|NCT00301795|Biological|oblimersen sodium|Given IV
12037948|NCT00301795|Biological|rituximab|Given IV
12037949|NCT00301795|Other|laboratory biomarker analysis|Correlative studies
12037950|NCT00301782|Biological|bleomycin sulfate|
12037951|NCT00301782|Drug|carboplatin|
12037952|NCT00301782|Drug|cisplatin|
12037953|NCT00301782|Drug|etoposide phosphate|
12037954|NCT00301782|Drug|vincristine sulfate|
12037955|NCT00301769|Drug|SJG-136|Given IV
12037956|NCT00301756|Drug|Belinostat|Given IV
12037957|NCT00301756|Other|Laboratory Biomarker Analysis|Correlative studies
12037958|NCT00301730|Biological|aldesleukin|
12037959|NCT00301730|Biological|therapeutic tumor infiltrating lymphocytes|
12037960|NCT00301730|Biological|trastuzumab|
12037961|NCT00301730|Drug|paclitaxel|
12037962|NCT00301730|Procedure|conventional surgery|
12037963|NCT00301691|Behavioral|behavioral dietary intervention|
12037964|NCT00301691|Other|educational intervention|
12037965|NCT00301691|Other|preventative dietary intervention|
12037966|NCT00301678|Behavioral|behavioral dietary intervention|
12037967|NCT00301678|Other|educational intervention|
12037968|NCT00301678|Other|preventative dietary intervention|
12037969|NCT00301665|Biological|Botulinum toxin type A|
12037970|NCT00301652|Drug|mycophenolate mofetil|MMF,1.0g/d
12037971|NCT00301639|Drug|OROS methylphenidate hydrochloride|
12037972|NCT00301639|Drug|methylphenidate hydrochloride|
12037973|NCT00301626|Behavioral|smoking reduction intervention (including NRT)|
12037974|NCT00301613|Drug|Mycophenolate mofetil|MMF,1.0g/d
12037975|NCT00301600|Drug|Mycophenolate mofetil|MMF,1.0g/d
12037976|NCT00301587|Drug|Norgestimate-ethinyl estradiol, with or without folic acid|
12037977|NCT00301574|Drug|galantamine|
12037978|NCT00301561|Procedure|Simplified follow-up approach of ARV treatment|"Simplify treatment follow-up :
~some clinical consultations will be performed by nurses under the physicians' responsibility ;
~the CD4 cell count and HIV-1 viral load will not be available for the management of patients ;
~the biologic assessment for tolerability will be limited"
12037979|NCT00301561|Procedure|Standard follow-up approach of ARV treatment|"Standard treatment follow-up :
~all clinical consultations will be performed by physicians ;
~the CD4 cell count and HIV-1 viral load will be available for the patients management routinely ;
~the biologic assessment for tolerability will be available as needed"
12037980|NCT00301548|Drug|perioperative chemotherapy|
12037981|NCT00301535|Drug|HBOC-201 (hemoglobin glutamer-250 bovine)|HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL
12037982|NCT00301522|Device|TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation|Paclitaxel-Eluting Coronary Stent, Slow-Formulation
12037983|NCT00301522|Device|Express2|Coronary Stent System
12037984|NCT00301509|Drug|peginterferon and ribavirin|
12037985|NCT00301496|Device|Coban 2 Layer Compression System|
12037986|NCT00301483|Drug|Hemoglobin-based oxygen carrier-201 (HBOC 201)|HBOC-201 is an investigational solution of sterile, ultrapurified, glutaraldehyde polymerized, modified bovine hemoglobin (Hb) in a balanced electrolyte solution. HBOC-201 has an Hb concentration of 12-14g/dL. HBOC-201 is an isosmotic solution that is stable for at least 36 months at 2-30ºC. It requires no reconstitution and can be administered directly into a peripheral or central vein. Blood typing is not required because all other cellular components, including the RBC membranes that carry the blood group antigens, have been removed.
12037987|NCT00301483|Other|Standard of Care|Standard Therapy
12037988|NCT00301470|Device|MR urography|undergoing both renal scintigraphy and MR within a month
12037989|NCT00301457|Drug|Anastrozole|1 mg once daily oral dose
12037990|NCT00301444|Device|mirror-box treatment|
12037991|NCT00301444|Behavioral|Mental visualization|
12037992|NCT00301431|Drug|DVS-233|
12037993|NCT00301418|Drug|Erlotinib|Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
12037994|NCT00301405|Drug|Thalidomide|Open label drug
12037995|NCT00301392|Other|life-style intervention|As the life-style interventions aiming to reduce the major risks of developing diabetes mellitus, instruct the following four items:(1)set diet right, (2)maintain normal weight,(3)improve physical activity,(4)normalize smoking and alcohol drinking.
12037996|NCT00301392|Drug|Life style interventions plus concomitant use of pitavastatin.|Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).
12037997|NCT00301379|Other|Observation data collection study.|This is a data collection study where the main purpose is to collect information about the treatments patients receive for their unresectable cholangiocarcinoma.
12037998|NCT00301366|Drug|alpha-1 proteinase inhibitor (human)|60 mg/kg weekly for 20 weeks
12037999|NCT00301353|Drug|Isoflavones-enriched foods|
12038000|NCT00301340|Drug|5% Lice Asphyxiator lotion - Summers Laboratories, Inc.|
12038001|NCT00301327|Drug|Summers 5% L.A.|
12038002|NCT00301314|Procedure|Autologous stem cell transplant|
12038003|NCT00301301|Drug|Gemcitabine|
12038004|NCT00301301|Drug|Cisplatinum|
12038005|NCT00301301|Drug|Rituximab|
12038006|NCT00301288|Procedure|Autologous stem cell transplant|
12038007|NCT00301262|Drug|Viagra (Sildenafil citrate)|
12038008|NCT00301236|Drug|Dexmethylphenidate HCl extended-release capsules|
12038009|NCT00301223|Drug|Pregabalin|
12038010|NCT00301210|Drug|Tramadol|oral doses four times per day
12038011|NCT00301197|Behavioral|Behavioral Skills Maintenance|
12038012|NCT00301197|Behavioral|Social Facilitation Maintenance|
12038013|NCT00301184|Biological|pGA2/JS7 DNA|DNA Vaccine
12038014|NCT00301184|Biological|Modified vaccinia Ankara/HIV62|Recombinant Modified Ankara Vaccine
12038015|NCT00301171|Drug|Inhaled Fluticasone|
12038016|NCT00301158|Behavioral|exercise intervention|
12038017|NCT00301158|Other|counseling intervention|
12038018|NCT00301158|Other|educational intervention|
12038019|NCT00301158|Procedure|complementary or alternative medicine procedure|
12038020|NCT00301145|Behavioral|smoking cessation intervention|
12038021|NCT00301145|Drug|varenicline|
12038022|NCT00301145|Other|counseling intervention|
12038023|NCT00301145|Other|internet-based intervention|
12038024|NCT00301106|Biological|adenovirus-mediated human interleukin-12|"The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/
~1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC."
12038025|NCT00301093|Biological|GM-K562 cell vaccine|Once weekly for 3 vaccination, then every other week for 3 vaccinations, and then every month for 3 vaccinations until the participant has received a total of 9 vaccinations
12038026|NCT00301093|Drug|imatinib mesylate|Participants will continue on current dose
12038027|NCT00301080|Drug|D-cycloserine|
12038028|NCT00301080|Other|Placebo|
12038029|NCT00301067|Dietary Supplement|Calcitriol|The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle
12038030|NCT00301067|Drug|Temozolomide|The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle
12038031|NCT00301054|Drug|Ferrous sulphate|
12038032|NCT00301054|Drug|Sulphadoxine-Pyrimethamine|
12038033|NCT00301041|Other|laboratory biomarker analysis|
12038034|NCT00301041|Procedure|adjuvant therapy|
12038035|NCT00301041|Radiation|radiation therapy|
12038036|NCT00301028|Biological|Cetuximab|Beginning weekly dose 400 mg/m^2 IV over 1-2 hours, and 250 mg/m^2 weeks 2-6.
12038037|NCT00301028|Drug|Carboplatin|AUC 2 weekly for 6 courses.
12038038|NCT00301028|Drug|Paclitaxel|135 mg/m^2 weekly for 6 courses.
12038039|NCT00301028|Procedure|Conventional Surgery|Following induction in second part of study.
12038040|NCT00301028|Radiation|Radiation Therapy|Following induction in second part of study.
12038041|NCT00301015|Device|Rapid diagnostic test for malaria|We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial
12038042|NCT00301002|Drug|Alefacept|
12038043|NCT00300989|Device|Inion OTPS Biodegradable Fixation System|
12038044|NCT00300976|Behavioral|Lifestyle consultation: weight control, diet, exercise|"Behavioral: Lifestyle modification including weight control, with the goal of BMI 22.
~Drug: Drugs are added in a stepwise manner to control blood glucose, blood pressure and lipid metabolism, using mainly hypoglycemic drugs, ACEI/ARB and statins, respectively. Management goals are: HbA1c < 6.2%, BP < 120/75 mmHg, HDL-C 40 mg/dL , LDL-C < 80 mg/dL, TG < 120 mg/dL.
~Follow-up study (Not provided)"
12038045|NCT00300976|Behavioral|Lifestyle consultation: weight control, diet, exercise|"Behavioral and Drug: The physician in charge is to administer appropriate therapy in accordance with the Guidelines.
~Follow-up study (Not provided)"
12038046|NCT00300963|Drug|Talnetant|
12038047|NCT00300950|Biological|GI-4000|Heat-killed yeast cell transfected with target ras mutation.
12038048|NCT00300950|Drug|Gemcitabine|Chemotherapy
12038049|NCT00300937|Dietary Supplement|Coenzyme Q10|100 mg oral BID starting at week 20 until delivery
12038050|NCT00300924|Drug|Rizatriptan co-administered with Acetaminophen|
12038051|NCT00300911|Drug|Rosiglitazone(drug), cardiac adverse effects|
12038052|NCT00300898|Procedure|Nucleoplasty|
12038053|NCT00300898|Procedure|Percutaneous decompression|
12038054|NCT00300898|Procedure|Intervertebral electrothermal disc decompression (IDET)|
12038055|NCT00300898|Behavioral|Conservative treatment|
12038056|NCT00300885|Drug|Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
12038057|NCT00300885|Drug|Carboplatin plus Paclitaxel|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
12038058|NCT00300872|Device|Continuous positive airway pressure (CPAP)|Continuous positive airway pressure (CPAP) - Horizon LT 8001 Continuous positive airway pressure (CPAP) device.
12038059|NCT00300872|Device|Sham Continuous positive airway pressure (CPAP)|Sham Continuous positive airway pressure (CPAP) - Continuous positive airway pressure (CPAP) units set to the lowest pressure (4 cm of water pressure) and 6 extra 4mm holes will be inserted in the collar of the main tubing at the end of the mask to allow air escape and to prevent carbon dioxide rebreathing.
12038060|NCT00300859|Behavioral|brief motivational intervention|
12038061|NCT00300846|Drug|aripiprazole|Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
12038062|NCT00300846|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
12038063|NCT00300833|Drug|Tirofiban|pci
12038064|NCT00300807|Drug|XTL 6865|
12038065|NCT00300794|Drug|Ketamine|
12038066|NCT00300781|Drug|neratinib|
12038067|NCT00300768|Drug|2 mg moxidectin|Single-dose, tablet encapsulated for blinding
12038068|NCT00300768|Drug|ivermectin 150 mcg/kg|Single-dose, tablets encapsulated for blinding
12038069|NCT00300768|Drug|4 mg moxidectin|Single dose, tablets encapsulated for blinding
12038070|NCT00300768|Drug|8 mg moxidectin|single dose, tablets encapsulated for blinding
12038071|NCT00300755|Drug|pantoprazole sodium enteric-coated spheroid|pediatric spheroids taken daily x 8 weeks
12038072|NCT00300742|Drug|Topiramate|Topiramate up to 300 mg per day.
12038073|NCT00300729|Drug|Celecoxib|Celecoxib 400 mg twice daily, orally, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.
12038074|NCT00300729|Drug|Placebo|One capsule twice daily, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.
12038075|NCT00300716|Drug|Memantine|
12038076|NCT00300690|Device|6 mm Uni-graft® (B-Braun)|
12038077|NCT00300690|Device|6 mm Gore-Tex® (WL Gore)|
12038078|NCT00300677|Drug|voriconazole|Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
12038079|NCT00300664|Drug|Human Growth hormone|
12038080|NCT00300651|Behavioral|Cognitive Behavioral Therapy|
12038081|NCT00300638|Procedure|Magnetic Resonance Imaging (MRI)|We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
12038082|NCT00300638|Behavioral|Interviews, cognitive tests, and emotional measurements|We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
12038083|NCT00300625|Procedure|Application of the San Francisco Syncope Rule|
12038084|NCT00300612|Biological|HyperAcute-Melanoma Vaccine|Cells will be injected intradermally every two weeks for twelve vaccinations. If the patient completes all twelve vaccinations, dosage will vary from a total of 1.3 x 109 to 3.8 x 109 HyperAcute™-Melanoma Vaccine cells administered.
12038085|NCT00300599|Device|Continuous Positive Airway pressure|Continuous positive pressure device with a time clock
12038086|NCT00300599|Other|Placebo|Placebo
12038087|NCT00300586|Drug|observation|observation, second line chemotherapy if progression
12038088|NCT00300586|Drug|gemcitabine|1250 mg/m² D1, D8 q21 days
12038089|NCT00300586|Drug|erlotinib|150 mg daily
12038090|NCT00300573|Drug|Dexelvucitabine|nucleoside inhibitor of HIV Reverse Transcriptase
12038091|NCT00300560|Drug|Colistin|
12038092|NCT00300547|Procedure|MR colonography|Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
12038093|NCT00300534|Device|Abbott Laboratories Determine test for syphilis|
12038094|NCT00300534|Device|Investigational syphilis immunochromatographic strip test|
12038095|NCT00300521|Genetic|ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy|
12038096|NCT00300508|Drug|Anastrozole|
12038097|NCT00300495|Drug|Amiodarone|Perioperative orally administered
12038098|NCT00300495|Other|Control arm, standard care|Control
12038099|NCT00300482|Drug|ABT-335|135 mg, daily, 12 weeks
12038100|NCT00300482|Drug|Rosuvastatin Calcium|Daily, 12 weeks, see Arm Description for dosage information
12038101|NCT00300482|Drug|Placebo|Daily, 12 weeks, see Arm Description for information regarding placebo type
12038102|NCT00300469|Drug|ABT-335|135 mg, daily, 12 weeks
12038103|NCT00300469|Drug|Atorvastatin|Daily, 12 weeks, see Arm Description for dosage information
12038104|NCT00300469|Drug|Placebo|daily, 12 weeks, see Arm Description for placebo information
12038105|NCT00300456|Drug|ABT-335|135 mg, daily, 12 weeks
12038106|NCT00300456|Drug|Simvastatin|daily, 12 weeks, see Arm Description for dosage information
12038107|NCT00300456|Drug|Placebo|Daily, 12 weeks, see Arm Description for placebo information
12038108|NCT00300443|Drug|bimatoprost|
12038109|NCT00300430|Drug|ABT-335 and rosuvastatin calcium|ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
12038110|NCT00300430|Drug|ABT-335 and atorvastatin calcium|ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
12038111|NCT00300430|Drug|ABT-335 and simvastatin|ABT-335 135 mg plus simvastatin daily, 52 weeks
12038112|NCT00300417|Drug|VRC-WNVDNA020-00-VP|
12038113|NCT00300404|Drug|daraprim|
12038114|NCT00300404|Drug|pyrimethamine|
12038115|NCT00300404|Drug|folinic acid|
12038116|NCT00300391|Drug|haloperidol|Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.
12038117|NCT00300391|Other|Saline placebo|control arem
12038118|NCT00300378|Drug|desvenlafaxine 50 mg|
12038119|NCT00300378|Drug|desvenlafaxine 100 mg|
12038120|NCT00300365|Drug|Pioglitazone|Pioglitazone, initially 30 mg, then titrated to 45 mg/day
12038121|NCT00300365|Other|Placebo|Pioglitazone placebo
12038122|NCT00300365|Drug|Niacin ER|Niacin ER 2.0 g/day
12038123|NCT00300365|Drug|Aspirin|asprin 325 mg/day
12038124|NCT00300352|Drug|Folic Acid|
12038125|NCT00300339|Drug|SL650472, Clopidogrel|
12038126|NCT00300326|Procedure|Computer assist|same implant using a computer-assisted surgical technique.
12038127|NCT00300313|Drug|Escitalopram|10 to 20 mg / day
12038128|NCT00300313|Drug|Placebo|1-2 capsules
12038129|NCT00300300|Procedure|Computer-assisted surgery|no description
12038130|NCT00300287|Drug|Vildagliptin|
12038131|NCT00300274|Drug|everolimus|Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
12038132|NCT00300274|Drug|mycophenolate mofetil|Mycophenolate mofetil supplied as 500 mg tablets.
12038133|NCT00300274|Drug|cyclosporine|Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
12038134|NCT00300274|Drug|corticosteroids|Corticosteroids standard dose.
12038135|NCT00300261|Behavioral|Telehealth monitoring|Experimental group receives telehealth monitoring equipment in their homes for the duration of home care. Equipment includes blood pressure cuff, scale, and pulse oximeter, or glucometer as needed. Two home care nurses provide video visits with subjects on the days when the home care nurse does not visit. Patients use the equipment daily and the results are downloaded to the nurse's computer at the home care agency where they are checked daily. The nurse acts on any abnormal readings by calling the patient, the home care nurse, or the physician.
12038136|NCT00300222|Drug|NGX-4010|
12038137|NCT00300196|Biological|Ancrod (Viprinex)|0.167 IU/kg/hr IV for 2-3 hours
12038138|NCT00300196|Drug|Placebo|0.6 mL/kg/hr
12038139|NCT00300157|Device|Percutaneous coronary intervention with Taxus stent|
12038140|NCT00300131|Device|Bioabsorbable Everolimus Eluting Coronary Stent|Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
12038141|NCT00300118|Drug|budesonide|9 mg
12038142|NCT00300118|Drug|mesalazine|4.5 g
12038143|NCT00300105|Drug|Tesaglitazar|
12038144|NCT00300092|Drug|Cepahlexin (drug)|Cephalexin 50 mg/kg divided 3 times daily for 7 days
12038145|NCT00300079|Drug|brinzolamide 1.0%|
12038146|NCT00300053|Device|stem cell injection|
12038147|NCT00300040|Drug|Hemoglobin glutamer 250 - bovine|intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)
12038148|NCT00300040|Drug|6% Hydroxyethylstarch|250ml for intravenous infusion
12038149|NCT00300027|Drug|BMS-582664|
12038150|NCT00300014|Procedure|Intravitreal triamcinolone injection|
12038151|NCT00300014|Procedure|Air-fluid exchange|
12038152|NCT00299988|Drug|Intravenous Immunoglobulin|
12038153|NCT00299988|Other|Placebo|
12038154|NCT00299975|Drug|MaZiRenWan (MZRW) Low dose|Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
12038155|NCT00299975|Drug|MaZiRenWan (MZRW) Median dose|Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
12038156|NCT00299975|Drug|MaZiRenWan (MZRW) High dose|Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
12038157|NCT00299962|Biological|Adenoviral-mediated Interferon-beta|BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
12038158|NCT00299962|Biological|SCH 721015|Comparison of different doses and frequency of investigational agent
12038159|NCT00299936|Drug|Ribavirin, PEG-Intron|
12038160|NCT00299923|Drug|Peginterferon alfa-2a, Ribavirin, Amantadine|
12038161|NCT00299910|Drug|Montelukast|
12038162|NCT00299897|Drug|SP01A|
12038163|NCT00299884|Drug|Lipitor 20 mg|A/A for 6 weeks
12038164|NCT00299884|Drug|Combination Ezetrol 10 mg and Lipidil Supra 160 mg|a/a for 6 weeks
12038165|NCT00299871|Drug|LIXISENATIDE (AVE0010)|
12038166|NCT00299858|Drug|Theophylline|"Patients assigned to study group, will receive slow-release theophylline at a dose of 10 mg/kg, titrated to blood levels between 55-110 umol/L, for a period of 4 weeks.
~Patients assigned to placebo group will receive identical-appearing placebo tablets for the same period of time."
12038167|NCT00299845|Drug|Lansoprazole|
12038168|NCT00299832|Drug|Aliskiren|
12038169|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
12038170|NCT00299819|Biological|MEDI 545|0.3 mg/kg IV (n=6) at Study Day 0
12038171|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
12038172|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
12038173|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
12038174|NCT00299806|Drug|Aliskiren|
12038175|NCT00299780|Drug|Stem cell mobilization|
12038176|NCT00299767|Procedure|sequential cord blood transplantation|Infused on Day 0
12038177|NCT00299754|Drug|Misoprostol|
12038178|NCT00299741|Drug|Sunitinib|Sunitinib 50 mg daily, 4/2 schedule
12038179|NCT00299728|Biological|NY-ESO-1 protein with CpG 7909 and Montanide|
12038180|NCT00299715|Drug|Paliperidone extended-release|
12038181|NCT00299702|Drug|Abilify|10-30 mg once daily for 104 weeks
12038182|NCT00299702|Drug|Risperidal Consta|25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks
12038183|NCT00299689|Drug|Denileukin diftitox|12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
12038184|NCT00299676|Drug|Galantamine (Reminyl)|Use of Reminyl according to approved NZ data sheet
12038185|NCT00299650|Drug|cisatracurium|
12038186|NCT00299650|Drug|Placebo|physiological serum infusion
12038187|NCT00299650|Drug|Cisatracurium besilate|Cisatracurium besilate infusion (900mg/day)
12038188|NCT00299611|Drug|Sertraline|Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
12038189|NCT00299611|Drug|Levetiracetam|Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
12038190|NCT00299611|Drug|Placebo|Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.
12038191|NCT00299598|Device|alkylated polyethylenimine nanoparticles antibacterial evaluation|
12038192|NCT00299585|Procedure|"using PD VitalOs Cement with dental implants"|supporting dental implants with Vitalos bone cement
12038193|NCT00299572|Drug|alendronate (Fosamax)|
12038194|NCT00299559|Drug|smart textiles containing menthol, camphor, cineol|application to skin
12038195|NCT00299546|Drug|Placebo|SC injections
12038196|NCT00299546|Biological|Golimumab 50 mg|SC injections
12038197|NCT00299546|Biological|Golimumab 100 mg|SC injections
12038198|NCT00299533|Drug|Fish oil (Super Omega-3, 4 caps/d) vs. placebo|
12038199|NCT00299520|Drug|intravenous iclaprim or intravenous linezolid|
12038200|NCT00299507|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
12038201|NCT00299507|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|One 0.5 mL posterior juxtascleral depot injection at 6 month intervals
12038202|NCT00299507|Other|Anecortave Acetate Vehicle|One 0.5 mL sham injection at 6 month intervals
12038203|NCT00299494|Drug|inotuzumab ozogamicin|IV, 1.8 mg/m2, q4w
12038204|NCT00299494|Drug|inotuzumab ozogamicin|IV, 1.8 mg/m2, q4w
12038205|NCT00299494|Drug|inotuzumab ozogamicin|IV, 1.8 mg/m2, q4w
12038206|NCT00299494|Drug|Rituximab|rituximab 375 mg/m^2 via IV infusion on Day 1
12038207|NCT00299468|Behavioral|Patient Activation Measure Intervention Package|
12038208|NCT00299455|Drug|amoxicillin-clavulanate|Amoxicillin clavulanate 40 mg/kg/day divided into two daily doses for 7 days. Capsules will be produced by pulverizing amoxicillin clavulanate tablets (Augmentin 875 mg; manufacturer Glaxo SmithKline Beecham; ATC Code: J01CR02) and mixing that with lactose monohydrate. Each capsule will contain Augmentin tablet powder 68 mg and lactose monohydrate 572 mg. This means amoxicillin 40 mg and clavulanate 5,7 mg respecting the dose per 2 kg.
12038209|NCT00299455|Drug|Placebo|Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.
12038210|NCT00299442|Behavioral|Self-help Triple P Behavioural Family Intervention|10-week self-help workbook and videos
12038211|NCT00299429|Procedure|Stenting and minimally invasive bypass surgery|
12038212|NCT00299429|Procedure|PCI with DES|PCI with DES
12038213|NCT00299416|Drug|Caffeinol|Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.
12038214|NCT00299416|Procedure|hypothermia|External or internal cooling for 24 hours and rewarming over 12 hours.
12038215|NCT00299403|Procedure|Right prefrontal lowfrequency ( 1 hz) rTMS.|"Right prefrontal low frequency (1 hz) rTMS. 15 sessions with one daily session during 3 weeks (weekends excluded). Each session covering 2 x 60 minutes of stimulation separated with an intertrain interval of 3 minutes
~Arms: 2"
12038216|NCT00299403|Procedure|Electroconvulsive therapy (ECT)|9 ECT ( 3 each week) during 3 weeks
12038217|NCT00299390|Drug|Sagopilone (BAY86-5302, ZK 219477)|Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion
12038218|NCT00299377|Drug|Abciximab i.v.|
12038219|NCT00299377|Drug|Abciximab i.c.|
12038220|NCT00299364|Drug|Black Cohosh (iCR) or tibolone|
12038221|NCT00299351|Drug|Depsipeptide|
12038222|NCT00299338|Drug|SP01A|
12038223|NCT00299325|Drug|Rimonabant|Tablet, oral administration
12038224|NCT00299325|Drug|Placebo (for Rimonabant)|Tablet, oral administration
12038225|NCT00299325|Other|Mild hypocaloric diet|Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity
12038226|NCT00299286|Drug|Lapatinib|"In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).
~Lapatinib tablets are dispensed as 250mg tablets. Patients should be advised to take all 6 tablets at once as one dose (total daily dose 1500mg). Tablets should be taken on an empty stomach either one hour before or one hour after a meal at the same time each day and according to the instructions on the bottle."
12038227|NCT00299286|Drug|Lapatinib-Placebo|"In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).
~Lapatinib-placebo tablets will be composed of lactose, cellulose, starch, magnesium stearate, and coated with Opadryl orange and look the same as the active treatment. The patients should take all 6 tablets at once as one dose."
12038228|NCT00299273|Behavioral|Low calorie high fat/protein diet|6 weeks of caloric restriction (50%) on a high fat/protein diet
12038229|NCT00299260|Biological|CMV gB vaccine|20 micrograms
12038230|NCT00299260|Drug|Placebo|normal saline
12038231|NCT00299247|Drug|sulfadoxine/pyrimethamine|
12038232|NCT00299234|Drug|Atomoxetine|titration schedule: 0.5 to 1.5 mg/kg/day
12038233|NCT00299221|Drug|Tacrolimus|tacrolimus
12038234|NCT00299221|Drug|combination therapy|MMF
12038235|NCT00299208|Drug|Artesunate|
12038236|NCT00299208|Drug|Azithromycin|
12038237|NCT00299208|Drug|Quinine|
12038238|NCT00299195|Drug|sulindac|Sulindac 150 mg po bid x 24 weeks
12038239|NCT00299195|Drug|Placebo|Placebo bid x 24 weeks
12038240|NCT00299182|Drug|AMG 531|Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.
12038241|NCT00299182|Drug|Rituximab|375 mg/m^2 by vein over 4-6 hour infusion day 1, each cycle.
12038242|NCT00299182|Drug|Cyclophosphamide|300 mg/m^2 by vein over 3 hours every 12 hours for 6 doses (days 2-4), Cycles 1,3, & 5.
12038243|NCT00299182|Drug|Vincristine|1.4 mg/m^2/dose (maximum 2 mg) by vein over 15 minutes Days 5 and 12, Cycles 1,3,& 5.
12038244|NCT00299182|Drug|Doxorubicin|50 mg/m^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,& 5.
12038245|NCT00299182|Drug|Dexamethasone|40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,& 5.
12038246|NCT00299182|Drug|Methotrexate|200 mg/m^2 by vein over 2 hours followed by 800 mg/m^2 over 22 hours Day 2, Cycles 2, 4 & 6.
12038247|NCT00299182|Drug|Cytarabine|3 g/m^2 by vein over 2 hours every 12 hours for 4 doses, days 3 & 4; OR,1 g/m^2 by vein over 2 hours every 12 hours for 4 doses, days 3 & 4 for patients > 60 years and for patients with serum creatinine > 1.5 mg/dL; Cycles 2,4,& 6.
12038248|NCT00299182|Drug|Placebo|Arm A: Placebo - subcutaneous injection administered on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm B: Placebo - subcutaneous injection administered on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.
12038249|NCT00299169|Behavioral|N of 1 Trials|N of 1 Trials of statin therapy
12038250|NCT00299156|Drug|Clofarabine|Starting dose 10 mg (Group 1) or 20 mg (Group 2) as tablets once a day for 5 days in a row and repeated every 4-8 weeks. Each 4-8 week period is a cycle.
12038251|NCT00299130|Drug|Folate|A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.
12038252|NCT00299130|Drug|Methotrexate|A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.
12038253|NCT00299130|Drug|Methylprednisolone|Intravenous infusion
12038254|NCT00299130|Drug|Placebo|Placebo to rituximab intravenous infusion
12038255|NCT00299130|Drug|Rituximab|Intravenous infusion
12038256|NCT00299117|Behavioral|Brief preoperative smoking intervention|One counseling session of approximately 45 minutes duration 3-4 days preoperatively. The intervention is inspired by the principles of motivational interviewing and The Stages of Change Model.
12038257|NCT00299104|Drug|folate|Intravenous repeating dose
12038258|NCT00299104|Drug|methotrexate|Oral or parenteral repeating dose
12038259|NCT00299104|Drug|methylprednisolone|Intravenous repeating dose
12038260|NCT00299104|Drug|placebo|Intravenous repeating dose
12038261|NCT00299104|Drug|rituximab|Intravenous repeating dose
12038262|NCT00299091|Drug|Efavirenz capsules 200 mg and 600 mg|Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring)
12038263|NCT00299065|Drug|Zileuton injection|
12038264|NCT00299052|Device|Grafton DBM|Grafton DBM will be mixed with bone reamings obtained during tibia IMN and place at the fracture site
12038265|NCT00299052|Biological|Reamings|Bone reamings obtained during tibia IMN will be placed at the fracture site
12038266|NCT00299039|Drug|acetaminophen plus codeine|capsules four times daily until pain free or for a maximum of seven days
12038267|NCT00299039|Drug|acetaminophen plus ibuprofen|capsules four times daily until pain free or for a maximum of seven days
12038268|NCT00299026|Device|NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System|
12038269|NCT00299013|Drug|COLAL-PRED®|COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
12038270|NCT00299013|Drug|Prednisolone|Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
12038271|NCT00299000|Drug|Naglazyme|Weekly infusion for minimum of 52 weeks. Naglazyme is diluted in sterile 0.9% sodium chloride solution
12038272|NCT00298987|Drug|Dasatinib|Tablets, Oral, 70 mg, Twice daily, 2 months.
12038273|NCT00298974|Drug|hydrocodone / acetaminophen extended release|2 tablets twice daily
12038274|NCT00298974|Drug|Placebo|2 tablets twice daily
12038275|NCT00298961|Device|Videoconference equipment FALCON/IP|
12038276|NCT00298935|Procedure|Osteopathic manipulative treatment (OMT)|
12038277|NCT00298922|Drug|Azithromycin|500 mg tablets orally thrice weekly for 24 weeks
12038278|NCT00298922|Drug|Placebo|tablet orally thrice weekly for 24 weeks
12038279|NCT00298909|Behavioral|physical exercise|physical exercise
12038280|NCT00298909|Drug|niaspan (extended-release niacin)|niaspan (extended-release niacin)
12038281|NCT00298909|Drug|niacin|niacin extended-release
12038282|NCT00298909|Other|control|control
12038283|NCT00298896|Drug|SNS-595|
12038284|NCT00298883|Drug|Myfortic|Myfortic 360mg PO BID for six weeks
12038285|NCT00298870|Drug|Isoniazid|Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively
12038286|NCT00298870|Drug|isoniazed|Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all
12038287|NCT00298857|Drug|Valproic acid|
12038288|NCT00298831|Drug|Sugammadex|At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.
12038289|NCT00298831|Drug|Rocuronium|Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.
12038290|NCT00298792|Behavioral|Cognitive Behavioral Treatment|Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.
12038291|NCT00298792|Behavioral|Cognitive-behavioral treatment|Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety
12038292|NCT00298779|Drug|omeprazole and bortezomib|
12038293|NCT00298766|Drug|VELCADE|"Once weekly at: 0.7, 1.0, 1.3 or 1.6 mg/m2
~Or
~Twice-weekly at: 0.7, 1.0, or 1.3 mg/m2"
12038294|NCT00298753|Procedure|fluid restriction for 14 days (15ml fluid per kg weight)|
12038295|NCT00298740|Device|Aventis U-400 Insulin|
12038296|NCT00298727|Behavioral|SHIPS|Stakeholder-Hosted Interactive Problem-based Seminars
12038297|NCT00298727|Behavioral|ePBL|Online Problem-Based Course
12038298|NCT00298714|Drug|Losartan|
12038299|NCT00298701|Biological|ALK Grass tablet|
12038300|NCT00298688|Drug|Gefitinib|
12038301|NCT00298675|Drug|BSI-201 (iniparib)|BSI-201 administered intravenously (IV), 2x weekly
12038302|NCT00298675|Drug|irinotecan|Irinotecan administered weekly, IV.
12038303|NCT00298662|Drug|Interferon beta-1b and Tacrolimus|
12038304|NCT00298649|Behavioral|Lay Health Advisor|
12038305|NCT00298636|Drug|adenosine|
12038306|NCT00298623|Drug|XP13512 (GSK1838262)|
12038307|NCT00298623|Other|placebo|
12038308|NCT00298610|Drug|Artesunate|Intravenous Artesunate (2.4 mg/kg) once a day for three days
12038309|NCT00298610|Drug|Malarone|(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
12038310|NCT00298597|Drug|granulocyte - colony stimulating factor (G-CSF)|
12038311|NCT00298597|Drug|erythropoetin (EPO)|
12038312|NCT00298584|Procedure|Percutaneous Suprapubic Aspiration|
12038313|NCT00298584|Procedure|Urethral Catheterization|
12038314|NCT00298571|Drug|.5% bupivacaine with epinephrine|
12038315|NCT00298558|Behavioral|Cognitive Training|Memory, Reasoning, or Speed of Processing cognitive training interventions
12038316|NCT00298545|Drug|placebo and Calcitriol|Placebo tablets twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
12038317|NCT00298545|Drug|Calcium and Calcitriol|Calcium twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
12038318|NCT00298532|Procedure|Advanced Life Support|
12038319|NCT00298506|Drug|Multitherapy|Tacrolimus,4mg/d, MMF 1.0g/d
12038320|NCT00298493|Procedure|Sedation management strategy|
12038321|NCT00298467|Drug|MDX-060|
12038322|NCT00298454|Drug|Furosemide|
12038323|NCT00298441|Drug|chondroitin sulfate-iron colloid|
12038324|NCT00298428|Procedure|blood samples|blood samples before percutaneous coronary intervention (PCI) and at 4 months
12038325|NCT00298415|Drug|Paclitaxel + Carboplatin|Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles)
12038326|NCT00298415|Drug|Monotherapy (gemcitabine or vinorelbine)|Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)
12038327|NCT00298363|Drug|Tenofovir disoproxil fumarate (tenofovir DF; TDF)|300-mg tablet QD
12038328|NCT00298363|Drug|Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)|FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD
12038329|NCT00298363|Drug|Entecavir (ETV)|0.5-mg or 1-mg tablet QD
12038330|NCT00298363|Drug|TDF placebo|Placebo to match TDF QD
12038331|NCT00298363|Drug|FTC/TDF placebo|Placebo to match FTC/TDF QD
12038332|NCT00298363|Drug|ETV placebo|Placebo to match ETV QD
12038333|NCT00298350|Drug|GS-9137 - A Novel HIV-1 Integrase Inhibitor|
12038334|NCT00298337|Drug|Mixture of probiotic bacteria and prebiotic oligosaccharide|
12038335|NCT00298324|Drug|Myfortic|1440mg twice daily
12038336|NCT00298324|Drug|Prednisone and Cyclosporine|Prednisone and Cyclosporine given according to protocol. The drugs are tapered according to patient response
12038337|NCT00298311|Behavioral|mci guidance peer support|12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
12038338|NCT00298298|Biological|L-Vax: Autologous, DNP-Modified NSCLC Vaccine|autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
12038339|NCT00298285|Drug|enoxaparin|
12038340|NCT00298272|Biological|IDEC-C2B8 (rituximab)|Participants will receive 500 mg rituximab on Day 1 and Day 15
12038341|NCT00298272|Drug|Placebo|Participants will receive placebo on Day 1 and Day 15
12038390|NCT00297895|Procedure|Completion Lymphadenectomy|complete lymph node dissection of lymph node basin with positive node
12038342|NCT00298272|Drug|Methotrexate|Participants must have been treated with MTX ≥15 mg per week and ≤25 mg per week (dose may have been as low as 10 mg if unable to tolerate higher dose) for at least 12 weeks immediately prior to Day 1, at a stable dose for at least 4 weeks and was continued for the study duration.
12038343|NCT00298272|Drug|Etanercept|Participants must have been treated with etanercept at 50 mg per week (25 mg twice per week or 50 mg once per week).
12038344|NCT00298272|Drug|Adalimumab|Participants must have been treated with adalimumab at 40 mg every other week for at least 12 weeks immediately prior to Day 1.
12038345|NCT00298272|Drug|Methylprednisolone|Methylprednisolone 100 mg IV was administered by slow infusion to be completed at least 30 minutes prior to each infusion of rituximab or placebo.
12038346|NCT00298272|Dietary Supplement|Folate|All subjects also received a stable dose of folate (≥5 mg per week).
12038347|NCT00298259|Procedure|operative fixation of fractured ribs|ORIFof fractured ribs in flail chest patients
12038348|NCT00298233|Drug|Oseltamivir|Oseltamivir is a sialic acid analogue that potently and specifically inhibits the viral neuraminidases by competitively and reversibly interacting with the active enzyme site of influenza A and B viruses. Oseltamivir will be administered orally in standard formulations (capsules for adults and children at least 15 years of age; suspension for children younger than 15 years).
12038349|NCT00298220|Behavioral|Feedback about patients at risk|GPTs receive this feedback about their patient population; obtained through premeasurement results
12038350|NCT00298220|Behavioral|Dissemination guideline and patient information letters|
12038351|NCT00298220|Behavioral|Tailored educational training|for GP(T)s
12038352|NCT00298220|Behavioral|Tailored outreach based facilitator support|in the practices of the GPTs
12038353|NCT00298220|Behavioral|Facilitation of co-operation with local addiction services|
12038354|NCT00298220|Behavioral|Patient directed interventions|Like poster for the waiting room, self-help booklets, folders
12038355|NCT00298220|Behavioral|Reminder-card for GP's desk|
12038356|NCT00298220|Behavioral|Personal feedback to patients|Patients receive advise based on their premeasurement answers
12038357|NCT00298207|Behavioral|Walking (behavior)|
12038358|NCT00298194|Drug|Z-338|
12038359|NCT00298181|Drug|YSPSL|YSPSL administered intravenously (IV) as a single bolus infusion open-label at 0.07, 0.22, 0.7 or 2.2 mg/kg
12038360|NCT00298168|Drug|YSPSL|YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
12038361|NCT00298168|Drug|placebo|0.9% normal saline administered IV as a single bolus infusion with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
12038362|NCT00298168|Drug|YSPSL|YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 10 mg YSPSL in 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
12038363|NCT00298155|Drug|goserelin with dutasteride|Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week.
12038364|NCT00298155|Drug|goserelin with bicalutamide and dutasteride|Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd.
12038365|NCT00298155|Drug|goserelin with bicalutamide and dutasteride and ketoconazole|Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg).
12038366|NCT00298142|Procedure|Usual Care provided by a medical doctor (GP or Neurologist)|
12038367|NCT00298142|Procedure|Usual care plus Physio-/ Manual Therapy|
12038368|NCT00298129|Device|Ambulatory blood pressure monitoring|
12038369|NCT00298090|Device|StO2 monitoring|placement of the StO2 device/ external noninvasive
12038370|NCT00298064|Genetic|Tissue Repository|
12038371|NCT00298051|Procedure|Delayed umbilical cord clamping|
12038372|NCT00298038|Drug|Rifaximin|Oral
12038373|NCT00298038|Drug|Placebo|Oral
12038374|NCT00298025|Drug|Cetrotide®|Cetrotide® will be administered subcutaneously as 3 mg injection when the lead follicle is >=14 mm till r-hCG day. If the subject did not achieve follicular maturation and did not receive r-hCG within 4 days, then the Cetrotide® will be administered at dose of 0.25 mg subcutaneously on successive days until r-hCG day.
12038375|NCT00298025|Drug|Antagon ™|Antagon™ will be administered subcutaneously at a dose of 0.25 mg once daily when the lead follicle is >=14 mm until r-hCG day.
12038376|NCT00298025|Drug|Recombinant human follicle stimulating hormone (r-hFSH)|Recombinant human follicle stimulating hormone (r-hFSH) will be administered at a starting dose of 225 international unit (IU) subcutaneously once daily from S1 up to Stimulation Day 5 (S5). Beginning on Stimulation Day 6 (S6), the r-hFSH dose will be individualized to the subject. The minimum and maximum daily doses are 75 IU and 450 IU, respectively until r-hCG day.
12038377|NCT00298025|Drug|Human Menopausal Gonadotropin (hMG)|Human menopausal gonadotropin (hMG) will be administered subcutaneously daily at a dose of 75 IU till r-hCG day. The total daily dose of r-hFSH and hMG combined is not to exceed 450 IU (375 IU r-hFSH and 75 IU hMG).
12038378|NCT00298025|Drug|Recombinant Human Choriogonadotropin (r-hCG)|The r-hCG will be administered as a single dose of 250 microgram (mcg) subcutaneously when there is at least one follicle of >=18 mm and two additional follicles of >=16 mm with an appropriate plasma estradiol levels for the number and size of the existing follicles. The r-hCG will be administered within 36 hours after the last dose of the r-hFSH/hMG.
12038379|NCT00298012|Drug|Methotrexate|
12038380|NCT00297986|Device|Helmet|Evaluation of different interfaces for NPPV
12038381|NCT00297973|Procedure|Blood pressure measurements|
12038382|NCT00297973|Procedure|Blood samples|
12038383|NCT00297960|Drug|ziprasidone or olanzapine|
12038384|NCT00297960|Procedure|hyperinsulinaemic euglycaemic clamp|
12038385|NCT00297960|Procedure|microdialysis (skeletal muscle)|
12038386|NCT00297947|Drug|quetiapine|Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
12038387|NCT00297947|Drug|quetiapine|Participant will receive 600 mg/day of quetiapine for 8 weeks.
12038388|NCT00297934|Device|Pro-adjuster mechanical spinal manipulative device|
12038391|NCT00297895|Procedure|Monitoring with nodal ultrasound|serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.
12038392|NCT00297882|Drug|Artemether-Lumefantrine , Amodiaquine-Artesunate|"Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
~Amodiaquine-ArtemetherD0(0H),D1(24H),D2(48H)- Artesunate 4mg/kg and Amodiaquine at 10mg/kg"
12038393|NCT00297869|Procedure|Computer-Assisted Decision Support|Electronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance)
12038394|NCT00297856|Biological|Boostrix®|Single dose
12038395|NCT00297856|Biological|Td (Tetanus diphtheria) vaccine|Single dose
12038396|NCT00297843|Procedure|allergen challenge (grass pollen), nasal lavage|
12038397|NCT00297830|Drug|Zoledronic acid|Drug is administered through 5 mg intravenous infusion over 20 minutes
12038398|NCT00297830|Drug|Alendronate|Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal
12038399|NCT00297830|Other|Placebo Zoledronic Acid|Infusion of placebo zoledronic acid during the first 5 weeks after transplantation
12038400|NCT00297830|Other|Placebo Alendronate|Placebo alendronate 70 mg once weekly
12038401|NCT00297817|Biological|serogroup B meningococcal vaccine|0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
12038402|NCT00297817|Biological|serogroup B meningococcal vaccine|0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
12038403|NCT00297817|Biological|serogroup B meningococcal vaccine|0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.
12038404|NCT00297804|Device|TAXUS Express Paclitaxel-Eluting Coronary Stent System|Paclitaxel-Eluting Coronary Stent System
12038405|NCT00297804|Device|Control stent|control stent
12038406|NCT00297791|Procedure|surgery|randomized to open or laparoscopic technique
12038407|NCT00297778|Drug|Pramipexole|Dopamine agonist
12038408|NCT00297778|Other|Placebo|
12038409|NCT00297765|Drug|Tacrolimus, Prograf®|
12038410|NCT00297752|Drug|ceriumnitrate silversulfadiazine (flammacerium)|treatment of patients with facial burns with CE-SSD
12038411|NCT00297752|Drug|silversulfadiazine (flammazine)|treatment of patients with facial burns with SSD
12038412|NCT00297739|Drug|Risperidone|
12038413|NCT00297726|Behavioral|Self-Management Program|
12038414|NCT00297713|Drug|ALTU-238|
12038415|NCT00297700|Behavioral|Active referral|
12038416|NCT00297687|Biological|MnB rLP2086|
12038417|NCT00297674|Drug|Intravenous Clarithromycin|
12038418|NCT00297661|Device|Sirolimus-eluting stent|
12038419|NCT00297661|Device|Paclitaxel-eluting stent|
12038420|NCT00297648|Biological|Certolizumab pegol|Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.
12038421|NCT00297635|Device|GlucoDYNAMIX™ intervention system|
12038422|NCT00297635|Device|GlucoMON™ telemetry device|
12038423|NCT00297596|Drug|Trastuzumab|Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
12038424|NCT00297596|Drug|Oxaliplatin|"Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles.
~For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab"
12038425|NCT00297583|Drug|Insulin Glulisine|
12038426|NCT00297570|Drug|Pegylated Interferon and Imatinib|
12038427|NCT00297544|Drug|Viagra|
12038428|NCT00297531|Device|PerioWave|
12038429|NCT00297531|Procedure|Scaling and Root Planing|
12038430|NCT00297518|Device|PerioWave|
12038431|NCT00297518|Procedure|Scaling and Root Planing|
12038432|NCT00297505|Drug|citalopram|
12038433|NCT00297492|Behavioral|Reduction Phone Counseling|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date. This includes 5 counseling calls: 3 calls focused on reduction prior to the quit date, 1 call two days prior to the quit date to discuss common strategies for preparing to quit, and 1 call two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges during reduction and after the quit date.
12038434|NCT00297492|Behavioral|Abrupt Phone Counseling|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date. This includes 5 counseling calls: 1 to set a quit date, 1 two days prior to the quit date to discuss common strategies for preparing to quit, and 3 after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.
12038435|NCT00297492|Behavioral|Minimal Abrupt Phone Counseling|Minimal counseling to mimic intervention at a primary care office. This includes 2 counseling calls: 1 to set a quit date and 1 two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.
12038436|NCT00297492|Drug|Pre-Quit Nicotine Lozenges|"2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.
~4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.
~Replace each forgone cigarette during reduction with one lozenge. Use additional lozenges to combat cravings to smoke."
12038437|NCT00297492|Drug|Post-Quit Nicotine Lozenges|"2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.
~4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.
~Replace each forgone cigarette while abstinent with one lozenge. Use additional lozenges to combat cravings to smoke."
12038438|NCT00297479|Behavioral|MBAT Group Therapy|In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
12038439|NCT00297479|Drug|Nicotine|6 weeks of nicotine patch therapy
12038440|NCT00297479|Behavioral|Group Therapy|In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
12038441|NCT00297479|Behavioral|Individual Therapy|In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
12038442|NCT00297466|Drug|transdermal nicotine patches|
12038443|NCT00297466|Behavioral|Motivational interview|
12038444|NCT00297453|Behavioral|Internet-based smoking treatment|All participants have access to an Internet-based self-help intervention that includes social support through message boards. All participants have access to 10 weeks of nicotine replacement treatment.
12038445|NCT00297453|Behavioral|Individual Counseling|Six individual counseling sessions are provided over a 12 week treatment period. Participants also have access to a 10-week nicotine replacement treatment.
12038446|NCT00297453|Behavioral|self-help|Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.
12038447|NCT00297440|Behavioral|Cognitive-behavioral treatment|
12038448|NCT00297440|Behavioral|Exercise|
12038449|NCT00297427|Procedure|Acupuncture|Acupuncture twice weekly for 6 weeks.
12038450|NCT00297427|Other|Sham acupuncture|Twice a week for 6 weeks
12038451|NCT00297414|Other|No intervention|No study drug was administered to the patients. Data on vital status was obtained for patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.
12038452|NCT00297401|Drug|ruboxistaurin|32 mg, QD, PO, up to 8 weeks
12038453|NCT00297401|Drug|placebo|QD, PO, up to 8 weeks
12038454|NCT00297388|Drug|Risperidone, long-acting injectable|
12038455|NCT00297375|Drug|tramadol HCl/acetaminophen|
12038456|NCT00297362|Drug|Galantamine hydrobromide|247 patients with diagnosed mild to moderate Alzheimer disease.
12038457|NCT00297349|Drug|Topiramate|Individualization of the treatment should begin from 25 mg for 1 week.
12038458|NCT00297336|Drug|Topiramate|80 patients with diagnosed with migraine
12038459|NCT00297323|Drug|Topiramate|75 patients over the age of 2 years old with epilepsy.
12038460|NCT00297310|Drug|tacrolimus|
12038461|NCT00297297|Other|No intervention. Applying gene profiling on needle aspirates|
12038462|NCT00297284|Drug|Modafinil|
12038463|NCT00297271|Other|Current treatment practice of each participating physician|Patients will be observed for the evaluation of current management strategies.
12038464|NCT00297258|Drug|pazopanib|oral tablet
12038465|NCT00297245|Drug|cognitive function|
12038466|NCT00297232|Drug|Natalizumab|
12038467|NCT00297219|Drug|Low dialysate calcium|1.25 mmol/L dialysate calcium
12038468|NCT00297219|Drug|high dialysate calcium|1.75 mmol/L dialysate calcium
12038469|NCT00297206|Drug|Valaciclovir|Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
12038470|NCT00297193|Procedure|Autologous haematopoietic stem cell transplant|All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
12038471|NCT00297180|Drug|GW869682|
12038472|NCT00297167|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
12038473|NCT00297167|Drug|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
12038474|NCT00297167|Drug|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
12038475|NCT00297167|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
12038476|NCT00297154|Behavioral|Lifestyle Modification (diet, exercise, and behavior)|Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program.
12038477|NCT00297141|Drug|Capecitabine|chemotherapy oral use
12038478|NCT00297141|Drug|Oxaliplatin|chemotherapy intravenous use
12038479|NCT00297128|Drug|Capecitabine|825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
12038480|NCT00297128|Drug|Cetuximab|400mg/m2 week 1, 250mg/m2 week 2-4
12038481|NCT00297115|Drug|Roflumilast|500 mcg, once daily, oral administration in the morning
12038482|NCT00297115|Drug|Placebo|once daily
12038483|NCT00297102|Drug|Roflumilast|500 mcg, once daily, oral administration in the morning
12038484|NCT00297102|Drug|Placebo|once daily
12038485|NCT00297089|Drug|ABT-751|200 mg ABT-751 daily for 14 days every 21 days
12038486|NCT00297089|Drug|pemetrexed|Standard pemetrexed every 21 days
12038487|NCT00297089|Drug|placebo|Placebo daily for 14 days every 21 days
12038488|NCT00297076|Drug|GW873140|
12038489|NCT00297063|Drug|Rosiglitazone|
12038490|NCT00297050|Drug|Peramivir|
12038491|NCT00297037|Drug|Pimecrolimus 1% cream|pimecrolimus cream or matching placebo BID for 6 weeks
12038492|NCT00297024|Procedure|MRI|Patients will be scanned while breathing in varying amounts of oxygen and carbon dioxide in varying amounts through a breathing device.
12038493|NCT00297011|Drug|valacyclovir+clobetasol gel|
12038494|NCT00296985|Device|Fresenius Cellsaver|
12038495|NCT00296972|Drug|peg interferon plus ribavirin|
12038496|NCT00296959|Drug|topiramate (drug)|
12038497|NCT00296946|Drug|ipratropium bromide (drug)|
12038498|NCT00296933|Drug|Escitalopram|
12038499|NCT00296933|Drug|Bupropion XL|
12038500|NCT00296920|Device|Deep Brain Stimulation|
12038501|NCT00296907|Behavioral|Brief psychological intervention|Psychoeducation, provision of medical knowledge, coping skills training
12038502|NCT00296894|Drug|Adalimumab (40 mg sc every other week)|Adalimumab (40 mg sc every other week)
12038503|NCT00296894|Drug|Placebo|Placebo
12038504|NCT00296881|Device|PERIOWAVE|
12038505|NCT00296868|Drug|ascorbic acid (vitamin C) versus placebo|
12038506|NCT00296855|Drug|Vasovist (BAY86-5283, MS-325)|All patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL
12038507|NCT00296842|Behavioral|Early psychological intervention|Psychoeducation, trauma narrative, provision of coping skills
12038508|NCT00296829|Biological|Inactivated, split-virion influenza vaccine|
12038509|NCT00296816|Drug|Bevacizumab (Avastin®)|15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity
12038510|NCT00296816|Drug|Docetaxel (Taxotere®)|75 mg/m^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
12038511|NCT00296816|Drug|Oxaliplatin (Eloxatin®)|85 mg/m^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
12038512|NCT00296803|Drug|clopidogrel|
12038513|NCT00296790|Drug|zolpidem tartrate|
12038514|NCT00296777|Drug|Escitalopram|8 weeks: up to 40 mg/day
12038515|NCT00296777|Drug|Bupropion|8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
12038516|NCT00296777|Drug|Imipramine|"8 weeks: up to 300mg/day
~*if patient does not have contraindication."
12038517|NCT00296751|Procedure|ECG recording|
12038518|NCT00296751|Procedure|Epidural catheter insertion|
12038519|NCT00296751|Drug|Intravenous meperidine injection|
12038520|NCT00296751|Drug|Epidural Bupivacaine and fentanyl injection|
12038521|NCT00296738|Device|SPECT/CT|GE INFINIA HAWKEYE
12038522|NCT00296725|Drug|Fluoxetine|Phase 1: Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated.
12038523|NCT00296725|Drug|Imipramine|Phase 2: Imipramine wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated.
12038524|NCT00296712|Drug|escitalopram + bupropion|same dosing as for monotherapy arms
12038525|NCT00296699|Drug|Duloxetine|"Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d.
~* dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating."
12038526|NCT00296686|Drug|Tranylcypromine|standard dose:60 mg/d for a minimum of 8 weeks, a maximum of 17 weeks; high dose for non-remitters: up to 120 mg/day for a maximum of 9 weeks.
12038527|NCT00296686|Drug|Dextroamphetamine|up to 40 mg/day for 9 weeks, in combination with high dose of tranylcypromine for patients not remitting on the standard or high doses of tranylcypromine alone.
12038528|NCT00296686|Drug|Triiodothyronine|For patients not remitting on higher dose of tranylcypromine plus dextroamphetamine: Up to 75 mg/day for 8 weeks(+/- dextroamphetamine) (max 8 weeks) in combination with highest does of tranylcypromine (up to 120mg/day).
12038529|NCT00296673|Device|Rehabilitation device|
12038530|NCT00296647|Drug|nicotine patch|Decreasing dosages from 21 to 7 mg over 12 week period
12038531|NCT00296647|Drug|nicotine patch|Decreasing dosage from 21 to 7 mg over 12 weeks
12038532|NCT00296647|Drug|nicotine lozenge|4 mg nicotine lozenge: dosage according to package directions for 16 weeks
12038533|NCT00296647|Drug|bupropion|dosage according to prescription directions: 12 weeks
12038534|NCT00296647|Drug|patch + lozenge|dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
12038535|NCT00296647|Drug|bupropion + lozenge|dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)
12038536|NCT00296634|Drug|Aluminum hydroxide|Aluminum hydroxide adjuvant at 1200 mcg/mL.
12038537|NCT00296634|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)|Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant. All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection. Vaccine with adjuvant is a turbid liquid whitish-grey in color. Vaccine without adjuvant is essentially clear and slightly opalescent in color.
12038538|NCT00296621|Drug|L-Glutamine|L-Glutamine
12038539|NCT00296621|Drug|placebo|placebo
12038540|NCT00296608|Drug|fluorouracil|
12038541|NCT00296608|Drug|leucovorin calcium|
12038542|NCT00296608|Procedure|conventional surgery|
12038543|NCT00296608|Radiation|radiation therapy|
12038544|NCT00296595|Behavioral|Nutrition|
12038545|NCT00296582|Behavioral|Gastric Motor Function Measurement|
12038546|NCT00296569|Drug|MK0686|
12038547|NCT00296556|Drug|Rivenprost (drug)|
12038548|NCT00296530|Drug|fluticasone propionate/salmeterol|
12038549|NCT00296530|Drug|fluticasone propionate|
12038550|NCT00296530|Drug|montelukast|
12038551|NCT00296517|Drug|323U66 (Bupropion Hydrochloride Sustained Release)|Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.
12038552|NCT00296517|Drug|Placebo|Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.
12038553|NCT00296504|Drug|fosamprenavir (GW433908)|
12038554|NCT00296504|Drug|ritonavir|
12038555|NCT00296491|Drug|fluticasone propionate/salmeterol (FSC)|fluticasone propionate/salmeterol DISKUS combination
12038556|NCT00296491|Drug|montelukast (MON)|montelukast capsule
12038557|NCT00296491|Drug|fluticasone propionate (FP)|fluticasone propionate aqueous nasal spray
12038558|NCT00296491|Drug|placebo nasal|vehicle placebo nasal spray
12038559|NCT00296491|Drug|ADVAIR DISKUS|ADVAIR DISKUS
12038560|NCT00296491|Drug|placebo capsule|placebo capsule
12038561|NCT00296491|Drug|placebo DISKUS|placebo DISKUS
12038562|NCT00296478|Drug|Endometrin|Endometrin 100mg BID x 10weeks
12038563|NCT00296478|Drug|Endometrin|Endometrin 100mg TID x 10weeks
12038564|NCT00296478|Drug|Crinone|Crinone QD x 10weeks
12038565|NCT00296465|Drug|Pulsatile gonadotropin-releasing hormone (GnRH)|Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
12038566|NCT00296465|Drug|Clomiphene Citrate|Oral clomiphene citrate (over encapsulated) for 5 days
12038567|NCT00296465|Drug|Placebo Pulsatile GnRH|Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
12038568|NCT00296465|Drug|Placebo Clomiphene Citrate|oral placebo clomiphene citrate for 5 days
12038569|NCT00296452|Behavioral|behavior|
12038570|NCT00296439|Behavioral|Behavior|
12038571|NCT00296426|Procedure|New technology - PAML|
12038572|NCT00296400|Drug|Rosuvastatin|
12038573|NCT00296400|Drug|Atorvastatin|
12038574|NCT00296387|Drug|Rosuvastatin|
12038575|NCT00296387|Drug|Atorvastatin|
12038576|NCT00296374|Drug|Rosuvastatin|10 mg oral dose administered once daily for 52 weeks
12038577|NCT00296374|Drug|Rosuvastatin|20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
12038578|NCT00296374|Drug|Atorvastatin|40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
12038579|NCT00296361|Drug|Tacrolimus|immunosuppression
12038580|NCT00296348|Drug|tacrolimus|immunosuppression
12038581|NCT00296348|Drug|mycophenolate mofetil|oral
12038582|NCT00296348|Drug|daclizumab|oral
12038583|NCT00296348|Drug|steroids|oral
12038584|NCT00296335|Drug|Mitomycin, doxifluridine and cisplatin|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
12038585|NCT00296335|Drug|Mitomycin and doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
12038586|NCT00296322|Drug|cisplatin, mitomycin-C, doxifluridine|"Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
~iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)"
12038587|NCT00296309|Drug|Tacrolimus|Immunosuppression
12038588|NCT00296296|Drug|Cyclosporin|Dose adjustment to pre-established targets
12038589|NCT00296296|Drug|Tacrolimus|Dose adjustment to pre-established targets
12038590|NCT00296296|Behavioral|'Diabetes Education / Management'|therapeutic adjustment to target ADA criteria
12038591|NCT00296283|Behavioral|integrative behavior couples therapy|
12038592|NCT00296270|Behavioral|Memory for truth|
12038593|NCT00296257|Drug|SMP-114|
12038594|NCT00296244|Drug|Steroids|Patients randomized to Control group shall be administered steroids as methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or Naso-gastric tube (NGT) on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT.
12038595|NCT00296244|Drug|Basiliximab|Basiliximab shall be given as induction therapy at 20 mg IV bolus intra-operatively and on the 4th day after transplantation.
12038596|NCT00296244|Drug|Tacrolimus|Tacrolimus shall be used as the main maintenance immuno-suppressive drug. It will be given at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter.
12038597|NCT00296244|Drug|Enteric-coated Mycophenolic acid (EC-MPA)|This drug may be given in combination with calcineurin inhibitors (tacrolimus) and steroids for maintenance immuno-prophylaxis to prevent rejection. They are particularly useful in recipients with renal dysfunction and neurotoxicity, when there is a need to reduce dose or delay introduction of calcineurin inhibitors. This drug is given at 720 mg PO BID for 3 months.
12038598|NCT00296231|Other|Nasal high frequency ventilation|use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
12038599|NCT00296218|Drug|Irbesartan|
12038600|NCT00296205|Drug|Cyclophosphamide|
12038601|NCT00296192|Drug|Rotigotine nasal spray|Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries
12038602|NCT00296192|Other|Placebo|placebo nasal spray 1, 2 3, and 4 puffs
12038603|NCT00296179|Drug|zolpidem tartrate|
12038604|NCT00296166|Procedure|Catheter ablation|
12038605|NCT00296166|Procedure|Thoracoscopic epicardial ablation|
12038606|NCT00296153|Drug|Omega-3-acid ethyl esters 90|Omacor capsule 1000mg x 4 per day. Duration 12 weeks
12038607|NCT00296140|Behavioral|self management of PSD symptoms|
12038608|NCT00296140|Procedure|screening and treatment of PSD|
12038609|NCT00296127|Drug|Celecoxib|
12038610|NCT00296114|Procedure|Serum and DNA Samples|To collect serum and DNA samples from subjects
12038611|NCT00296101|Behavioral|Physical Activity|
12038612|NCT00296062|Biological|bevacizumab|Phase II: IV over 30-90 minutes on days 1 and 15 of each course.
12038613|NCT00296062|Drug|capecitabine|Phase I: oral capecitabine twice daily on days 1-7 and 15-21.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine (during both odd- and even-numbered courses) until the maximum tolerated dose (MTD) is determined.Phase II:receive capecitabine (at the MTD determined in phase I(odd-numbered courses)
12038614|NCT00296062|Drug|irinotecan hydrochloride|Phase I: irinotecan hydrochloride IV over 90 minutes on days 1 and 15 during course 1 and all subsequent odd-numbered courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Phase II: receive capecitabine (at the MTD determined in phase I) in combination with irinotecan hydrochloride (during odd-numbered courses)
12038615|NCT00296062|Drug|oxaliplatin|"Phase I: oxaliplatin IV over 2 hours on days 1 and 15 during course 2 and all subsequent even-numbered courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
~Phase II: oxaliplatin (during even-numbered courses) as in phase I"
12038616|NCT00296049|Drug|daptomycin|
12038617|NCT00296049|Drug|vancomycin|
12038618|NCT00296036|Dietary Supplement|pyridoxine hydrochloride|Given orally
12038619|NCT00296036|Drug|urea/lactic acid-based topical cream|Applied topically
12038620|NCT00296036|Other|placebo|Given orally or applied topically
12038621|NCT00296023|Biological|anti-thymocyte globulin|
12038622|NCT00296023|Biological|filgrastim|
12038623|NCT00296023|Biological|therapeutic allogeneic lymphocytes|
12038624|NCT00296023|Drug|busulfan|
12038625|NCT00296023|Drug|fludarabine phosphate|
12038626|NCT00296023|Drug|methotrexate|
12038627|NCT00296023|Drug|tacrolimus|
12038628|NCT00296023|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
12038629|NCT00296023|Procedure|peripheral blood stem cell transplantation|
12038630|NCT00296010|Drug|cyclophosphamide|cyclophosphamide 50 mg/day orally continuously for 16 weeks
12038631|NCT00296010|Drug|methotrexate|methotrexate 2.5 mg twice a day orally on days 1 and 4 of every week for 16 weeks
12038632|NCT00296010|Drug|pegylated liposomal doxorubicin hydrochloride|Caelyx (R) (Doxil (R)) 20 mg/m2 iv x 8 doses (delivered every 2 weeks)
12038633|NCT00296010|Procedure|adjuvant therapy|
12038634|NCT00296010|Radiation|radiation therapy|Radiation therapy should be used according to institutional accepted guidelines. Radiation therapy to the conserved breast is recommended. Radiation therapy to the chest wall following mastectomy is optional (if given, it may also include nodal fields). Radiation therapy may be given either during operation or after all chemotherapy.
12038635|NCT00295997|Biological|anti-thymocyte globulin|
12038636|NCT00295997|Biological|filgrastim|
12038637|NCT00295997|Biological|graft-versus-tumor induction therapy|
12038638|NCT00295997|Biological|therapeutic allogeneic lymphocytes|
12038639|NCT00295997|Drug|busulfan|
12038640|NCT00295997|Drug|cyclophosphamide|
12038641|NCT00295997|Drug|fludarabine phosphate|
12038642|NCT00295997|Drug|methotrexate|
12038643|NCT00295997|Drug|mycophenolate mofetil|
12038644|NCT00295997|Drug|tacrolimus|
12038645|NCT00295997|Procedure|allogeneic bone marrow transplantation|
12038646|NCT00295997|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
12038647|NCT00295997|Procedure|peripheral blood stem cell transplantation|
12038648|NCT00295984|Drug|nicotine|
12038649|NCT00295971|Biological|anti-thymocyte globulin|
12038650|NCT00295971|Biological|therapeutic allogeneic lymphocytes|
12038651|NCT00295971|Drug|fludarabine phosphate|
12038652|NCT00295971|Drug|thiotepa|
12038653|NCT00295971|Procedure|allogeneic bone marrow transplantation|
12038654|NCT00295971|Procedure|allogeneic hematopoietic stem cell transplantation|
12038655|NCT00295971|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12038656|NCT00295971|Radiation|total-body irradiation|
12038657|NCT00295958|Biological|LMB-2 immunotoxin|
12038658|NCT00295958|Biological|MART-1 antigen|
12038659|NCT00295958|Biological|gp100 antigen|
12038660|NCT00295958|Biological|incomplete Freund's adjuvant|
12038661|NCT00295945|Drug|fentanyl citrate|
12038662|NCT00295945|Drug|hydromorphone hydrochloride|
12038663|NCT00295945|Drug|ropivacaine hydrochloride|
12038664|NCT00295932|Biological|rituximab|Given IV
12038665|NCT00295932|Drug|bortezomib|Given IV
12038666|NCT00295932|Drug|cyclophosphamide|Given IV
12038667|NCT00295932|Drug|prednisone|Given orally
12038668|NCT00295919|Drug|fenretinide lipid matrix|
12038669|NCT00295919|Drug|ketoconazole|
12038670|NCT00295919|Other|laboratory biomarker analysis|
12038671|NCT00295919|Other|pharmacological study|
12038672|NCT00295906|Other|educational intervention|
12038673|NCT00295906|Other|internet-based intervention|
12038674|NCT00295893|Biological|trastuzumab|Given IV
12038675|NCT00295893|Drug|carboplatin|Given IV
12038676|NCT00295893|Drug|cyclophosphamide|Given IV
12038677|NCT00295893|Drug|docetaxel|Given IV
12038678|NCT00295893|Drug|doxorubicin hydrochloride|Given IV
12038679|NCT00295893|Drug|paclitaxel|Given IV
12038680|NCT00295880|Procedure|umbilical cord blood transplantation|The graft will be given by slow injection into each posterior iliac crest.
12038681|NCT00295867|Drug|Zoledronic Acid|Zoledronic acid is a new, highly potent, heterocyclic nitrogen-containing third generation bisphosphonate that has demonstrated 40- to 850- fold greater potency than pamidronate in preclinical models of bone resorption. The mechanism of action of nitrogen-containing bisphosphonates such as pamidronate and zoledronic acid appears to involve inhibition of the mevalonate pathway
12038682|NCT00295854|Drug|MN-001 BID|Eligible patients received 500 mg MN-001 bid
12038683|NCT00295854|Drug|MN-001|Eligible patients received 500 mg MN-001 once daily (qd)
12038684|NCT00295854|Drug|Placebo|Eligible patients received placebo
12038685|NCT00295841|Drug|clofarabine|
12038686|NCT00295841|Drug|cytarabine|
12038687|NCT00295828|Other|Pegaptanib Sodium Injection/Panretinal Photocoagulation|Pegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure.
12038688|NCT00295828|Procedure|Panretinal Photocoagulation (PRP)|Ocular Laser Procedure
12038689|NCT00295815|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
12038690|NCT00295815|Drug|lomustine|100-130 mg/m2, oral once, every 6 weeks until PD
12038691|NCT00295802|Device|Integrated Imaging High Intensity Focused Ultrasound|
12038692|NCT00295802|Device|Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)|Cryotherapy
12038693|NCT00295789|Drug|chemotherapy: Paclitaxel/Cisplatin|Drug: chemotherapy: Paclitaxel/Cisplatin
12038694|NCT00295789|Drug|chemotherapy: Paclitaxel/Carboplatin|Drug: chemotherapy: Paclitaxel/Carboplatin
12038695|NCT00295776|Drug|Lamictal in the treatment of Post-Herpetic Neuralgia|
12038696|NCT00295763|Drug|Thyrogen (thyrotropin alfa for injection)|"No reference therapy was given. All patients in this follow-up study received Thyrogen. Thyrogen 0.9 mg was administered intramuscularly (IM) in the buttock on 2 consecutive days.
~For WBS and static neck imaging, each patient received 4 mCi (148 MBq) ± 0.4 mCi 131I PO."
12038697|NCT00295750|Drug|Degarelix|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
12038698|NCT00295750|Drug|Degarelix|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
12038699|NCT00295750|Drug|Leuprolide 7.5 mg|Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
12038700|NCT00295737|Procedure|bronchoscopy, allergen/endotoxin instillation|
12038701|NCT00295724|Drug|Bicifadine|
12038702|NCT00295711|Drug|Bicifadine|
12038703|NCT00295698|Drug|Diethylcarbamazine|
12038704|NCT00295685|Drug|Antacids|
12038705|NCT00295672|Drug|Vinorelbine|
12038706|NCT00295646|Drug|tamoxifen|20 mg/d
12038707|NCT00295646|Drug|anastrozole|1 mg/d
12038708|NCT00295646|Drug|zoledronic acid|4 mg q6m
12038709|NCT00295633|Drug|Saxagliptin|Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)
12038710|NCT00295633|Drug|Saxagliptin|Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)
12038711|NCT00295633|Drug|Placebo|Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)
12038712|NCT00295633|Drug|pioglitazone|Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
12038713|NCT00295633|Drug|rosiglitazone|Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
12038714|NCT00295633|Drug|metformin|Tablets, Oral, 500-2500 mg, as needed (12 months LT)
12038715|NCT00295620|Drug|Anastrozole|1mg tablet daily
12038716|NCT00295607|Drug|Tacrolimus|immunosuppression
12038717|NCT00295607|Drug|steroids, monoclonal anti-IL2R antibody|immunosuppression
12038718|NCT00295594|Drug|tacrolimus|Immunosuppression
12038719|NCT00295581|Drug|PpPfs25/ISA51 & ScPvs25/ISA51|
12038720|NCT00295555|Drug|Effects of doxazosin on morning surge in diabetic patients|
12038721|NCT00295542|Device|Ambulatory blood pressure monitoring|Sampling at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
12038722|NCT00295542|Procedure|Chronotherapy, timing of antihypertensive medication|Comparison of effects of awakening versus bedtime dosing
12038723|NCT00295542|Drug|ACEI (including spirapril, enalapril, quinapril, lisinopril)|Treatment at awakening versus bedtime
12038724|NCT00295542|Drug|ARB (including valsartan, telmisartan, olmesartan)|Treatment at awakening versus bedtime
12038725|NCT00295542|Drug|beta blockers (including nebivolol, atenolol, carvedilol)|Treatment at awakening versus bedtime
12038726|NCT00295542|Drug|diuretics (torasemide, indapamide, HTCZ) and doxazosin|Treatment at awakening versus bedtime
12038727|NCT00295542|Procedure|Combination therapy in essential hypertension|Treatment at awakening versus bedtime
12038728|NCT00295529|Behavioral|Multifaceted educational intervention|Educational materials available at end of study
12038729|NCT00295516|Procedure|Fetal Middle Cerebral Artery Doppler measurement|
12038730|NCT00295503|Drug|bevacizumab|15 mg/kg IV every 3 weeks
12038731|NCT00295503|Drug|cisplatin|75 mg/m2 IV every 3 weeks
12038732|NCT00295503|Drug|pemetrexed|500 mg/m2 every 3 weeks
12038733|NCT00295490|Drug|Devil Claw|Dose ranging study so will elucidate dose Frequency is four times daily
12038734|NCT00295490|Drug|Placebo|Placebo has same dosing freq as for active intervention and for same time period
12038735|NCT00295477|Genetic|VRX496|In Step 1 of the protocol, each subject will receive up to 2 cycles of VRX496. Each treatment cycle consists of 3 infusions of VRX496.
12038736|NCT00295464|Drug|Betamethasone sodium phos (drug)|
12038737|NCT00295438|Device|Robot-Based Tele-Echography (TER)|Robot-Based Tele-Echography, ultrasound performed by the radiologist
12038738|NCT00295438|Device|ultrasound method FAST|FAST,ultrasound performed by the emergency doctor
12038739|NCT00295425|Drug|Cyclosporine A versus mycophenolate mofetil for psoriasis|
12038740|NCT00295412|Drug|quetiapine (drug)|
12038741|NCT00295399|Device|The Jerusalem Telerehabilitation System|
12038742|NCT00295386|Behavioral|Cognitive behavior therapy (CBT)|
12038743|NCT00295386|Drug|Zopiclone|
12038744|NCT00295373|Drug|Rosuvastatin|
12038745|NCT00295373|Behavioral|Exercise Training|
12038746|NCT00295360|Behavioral|no intervention, pathophysiological study|
12038747|NCT00295347|Drug|Spironolactone|
12038748|NCT00295347|Drug|fludrocortisone|
12038749|NCT00295347|Drug|escitalopram|
12038750|NCT00295334|Drug|alcohol|
12038751|NCT00295308|Drug|Clonidine|clonidine up to 0.3 mg/day oral
12038752|NCT00295308|Drug|Placebo|oral capsules daily
12038815|NCT00294723|Drug|placebo|Liraglutide placebo, 200 mcl
12038816|NCT00294723|Drug|placebo|Liraglutide placebo, 300 mcl
12038753|NCT00295295|Device|High frequency, low magnitude vibration|High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
12038754|NCT00295295|Other|Standing|Standing 10 min/day
12038755|NCT00295282|Drug|MDX-1100 (anti-CXCL10 human monoclonal antibody)|Patients will receive a single dose of MDX-1100 at 0.3, 1.0, 3.0 or 10 mg/kg as a 60 minute intravenous infusion. Patients who respond to treatment may receive up to an additional 3 doses of MDX-1100.
12038756|NCT00295269|Drug|Mythylprednisolone|
12038757|NCT00295256|Behavioral|nurse case manager|
12038758|NCT00295243|Drug|Topotecan|
12038759|NCT00295230|Procedure|PSV+VG mode versus SIMV+VG mode|fully assisted mechanical ventilation versus assistance on only a select number of breaths
12038760|NCT00295217|Device|ExAblate 2000|
12038761|NCT00295191|Procedure|high-flux membrane|high-flux dialyser
12038762|NCT00295191|Procedure|low-flux membrane|low-flux dialyser
12038763|NCT00295191|Procedure|conventional dialysate|conventional dialysate
12038764|NCT00295191|Procedure|ultrapure dialysate|ultrapure dialysate
12038765|NCT00295178|Drug|Daptomycin|
12038766|NCT00295178|Drug|Vancomycin|
12038767|NCT00295165|Drug|Sargramostim (Leukine)|Sargramostim 6 mcg/kg subcutaneously once daily
12038768|NCT00295165|Drug|Placebo|Placebo subcutaneously once daily
12038769|NCT00295152|Behavioral|community occupational therapy in dementia|
12038770|NCT00295139|Behavioral|Behavioral Treatment for Substance Abuse in SPMI (BTSAS)|Multifaceted treatment for substance abuse in dual disordered patients which contains 6 components: 1) a urinalysis contingency to enhance motivation to change and increase the salience of goals; 2) structured goal setting to identify realistic, short term goals for decreased substance use; 3) motivational interviewing to enhance motivation to reduce use; 4) social skills and drug refusal skills to enable development of relationships with people who do not use drugs, and to provide success experiences that can increase self-efficacy for change; 5) education about the reasons for substance use and the particular dangers of substance use for people with SPMI; and 6) relapse prevention training that focuses on behavioral skills for coping with urges and dealing with high risk situations and lapses. BTSAS is specifically structured to reduce the load on memory and attention, and minimize demands on higher level cognitive processes.
12038771|NCT00295139|Behavioral|Supportive Treatment in Addiction Recovery (STAR)|Manualized substance abuse treatment as usual
12038772|NCT00295139|Behavioral|Critical Time Intervention (CTI)|Case management component
12038773|NCT00295126|Procedure|cellular therapy : Autologous platelet concentrate (APC)|
12038774|NCT00295113|Procedure|EFR|
12038775|NCT00295100|Drug|Tamoxifen|
12038776|NCT00295074|Procedure|neuropsychologic testing|
12038777|NCT00295061|Drug|Alpha-1 MP|alpha-1 proteinase inhibitor (human), 60 mg/kg body weight
12038778|NCT00295061|Drug|alpha-1 proteinase inhibitor (human)|Prolastin
12038779|NCT00295048|Behavioral|Computer Assisted Cognitive Remediation (CACR)|
12038780|NCT00295035|Drug|CELECOXIB|
12038781|NCT00295035|Drug|CURCUMIN|
12038782|NCT00295022|Drug|Placebo|"Pharmaceutical form: Over-encapsulated tablet
~Route of administration: Oral use"
12038783|NCT00295022|Drug|Montelukast|"Pharmaceutical form: Over-encapsulated tablet
~Concentration: 10 mg
~Route of administration: Oral use"
12038784|NCT00295022|Drug|Levocetirizine|"Pharmaceutical form: Over-encapsulated tablet
~Concentration: 5 mg
~Route of administration: Oral use"
12038785|NCT00295009|Device|ProDisc|Total disc replacement with ProDisc
12038786|NCT00295009|Procedure|Spinal Fusion|A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
12038787|NCT00294996|Drug|Myocet|
12038788|NCT00294944|Drug|Idazoxan|
12038789|NCT00294931|Drug|irinotecan|
12038790|NCT00294931|Drug|carboplatin|
12038791|NCT00294931|Drug|bevacizumab|
12038792|NCT00294918|Drug|Serostim®|Serostim® will be administered subcutaneously at a dose of 1 mg to subjects who had encountered toxicity during the antecedent protocol (Study 22388) whereas, other subjects will be randomized in 1:1 ratio, to receive either 2 milligram (mg) or 4 mg (on a weight adjusted basis) daily, starting from Day 1 of Week 1 up to Week 12 (Period 1). During Period 1, subjects who encounter toxicity will receive 1 mg Serostim® subcutaneously, daily for Period 2, starting from Day 1 of Week 13, whereas other subjects will be randomized in a 1:1 ratio to receive either 2 mg or 1 mg (on a weight adjusted basis) up to Week 36.
12038793|NCT00294905|Behavioral|Implementation of a combined smoking cessation strategy|
12038794|NCT00294892|Drug|carbamazepine and nevirapine|Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
12038795|NCT00294892|Drug|Nevirapine|Nevirapine 200mg is taken prior to delivery during labor.
12038796|NCT00294879|Procedure|pressure support ventilation at 0, 5, and 10% IRT|
12038797|NCT00294866|Drug|Paricalcitol|Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.
12038798|NCT00294853|Procedure|MDCT calcium score|
12038799|NCT00294840|Device|PET-CT|
12038800|NCT00294827|Procedure|Liver transplantation and colo-rectal cancer|Liver transplantation
12038801|NCT00294814|Device|Proximal anastomosis using Heartstring anastomotic device|
12038802|NCT00294801|Drug|flex-a-new (food supplement)|
12038803|NCT00294788|Biological|Fluvax|
12038804|NCT00294788|Drug|PCC® (Lactobacillus fermentum VRI 003)|
12038805|NCT00294775|Drug|Candesartan|
12038806|NCT00294762|Drug|Tarceva|oral tablet
12038807|NCT00294762|Drug|carboplatin|IV
12038808|NCT00294762|Drug|paclitaxel|IV
12038809|NCT00294749|Drug|Ciprofloxacine|
12038810|NCT00294736|Drug|Tarceva|Dose Escalation: 150-350+ mg/day
12038811|NCT00294723|Drug|liraglutide|1.8 mg for s.c. (under the skin) injection
12038812|NCT00294723|Drug|glimepiride|8 mg capsule
12038813|NCT00294723|Drug|liraglutide|1.2 mg for s.c. (under the skin) injection
12038814|NCT00294723|Drug|placebo|Glimepiride placebo, 8mg capsule
12038817|NCT00294710|Drug|Aliskiren|
12038818|NCT00294684|Drug|Corticosteroids|"Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
12038819|NCT00294684|Drug|Placebo|"Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
12038820|NCT00294671|Drug|diflunisal|given twice daily for 24 months
12038821|NCT00294671|Other|placebo|an inactive substance given twice daily for 24 months
12038822|NCT00294658|Procedure|thymectomy plus prednisone|The thymectomy will be performed as soon as possible after randomization.
12038823|NCT00294658|Drug|prednisone alone|Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.
12038824|NCT00294645|Other|Transtelephonic monitoring (TTM)|TTM conducted at 2 month intervals. For patients with dual-chamber pacemakers, an in-office visit was required at 6 months (rather than TTM transmission for patients with single-chamber pacemakers). Follow-up frequency established to mimic best case standard of care when utilizing TTM for follow-up. A 12-month in-office visit completed the follow-up period.
12038825|NCT00294645|Other|Medtronic CareLink® Network|Remote pacemaker interrogation conducted at 3 month intervals. Follow-up frequency established to mimic best case standard of care when utilizing implantable cardioverter defibrillator (ICD) remote interrogation for follow-up. A 12-month in-office visit completed the follow-up period.
12038826|NCT00294632|Drug|Lenalidomide|Starting Dose 10 mg By Mouth Daily on Days 1-21
12038827|NCT00294632|Drug|Rituximab|375 mg/m^2 By Vein Weekly for 4 Weeks
12038828|NCT00294619|Drug|growth hormone|subcutaneous injection, once-weekly
12038829|NCT00294606|Drug|Comparison of Effects of Phenylephrine and Norepinephrine|
12038830|NCT00294593|Drug|folinic acid|
12038831|NCT00294580|Drug|Maloprim|
12038832|NCT00294567|Drug|Calcium channel blockers (amlodipine, azelnidipine)|Drug: amlodipine Drug: azelnidipine
12038833|NCT00294554|Drug|Memantine|Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed.
12038834|NCT00294554|Drug|Placebo Oral Tablet|Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed.
12038835|NCT00294541|Drug|ICA-17043|
12038836|NCT00294528|Device|Nexgen LPS-flex and AGC|
12038837|NCT00294515|Drug|Valganciclovir|900 mg orally daily for up to 100 days
12038838|NCT00294515|Drug|Valganciclovir|900 mg orally daily for up to 200 days
12038839|NCT00294502|Drug|Gentamycin/citrate, Minocycline/EDTA|
12038840|NCT00294476|Drug|IVIG|
12038841|NCT00294476|Procedure|Biological Therapy|
12038842|NCT00294463|Drug|Tibolone|
12038843|NCT00294463|Drug|Estradiol|
12038844|NCT00294463|Drug|Estradiol + Medroxy Progesterone Acetate|
12038845|NCT00294450|Device|Fistula Pouching System|3 different sizes of fistula pounching system
12038846|NCT00294437|Drug|Zometa|Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
12038847|NCT00294424|Procedure|Short waiting time|
12038848|NCT00294424|Procedure|Non-fixed waiting time|
12038849|NCT00294411|Procedure|elective cesarean section|
12038850|NCT00294398|Other|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
12038851|NCT00294398|Other|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
12038852|NCT00294385|Drug|Docetaxel|
12038853|NCT00294385|Drug|Gemcitabine, Docetaxel|Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
12038854|NCT00294385|Drug|Docetaxel|rm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
12038855|NCT00294372|Drug|BILR 355 BS|
12038856|NCT00294372|Drug|Placebo|
12038857|NCT00294359|Drug|Mitomycin C; Capecitabine; Bevacizumab|
12038858|NCT00294346|Drug|AV608|
12038859|NCT00294320|Drug|Aldara (Imiquimod)|250mg of Imiquimod cream for application once daily 3 times per week.
12038860|NCT00294320|Other|Vehicle cream|250mg vehicle cream for application once daily 3 times per week.
12038861|NCT00294307|Behavioral|Augmented Standard Care (ASC)|Standard hospital care and, if referred, home care plus early identification of CI during the patients' hospitalization by trained research assistants with immediate verbal feedback and documentation to patients' primary nurses, attending physicians and discharge planners [low intensity];
12038917|NCT00293800|Drug|Latanoprost 0.005% Ophthalmic Solution (XALATAN)|Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
12038862|NCT00294307|Behavioral|Resource Nurse Care (RNC)|Standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization (ASC) and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home [medium intensity];.
12038863|NCT00294307|Behavioral|Advanced Practice Nurse Care (APNC)|Standard hospital care plus ASC and transitional care starting in the hospital and substituting for standard home care and provided by Advanced Practice Nurses (APNs) with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers [high intensity].
12038864|NCT00294294|Biological|Prevenar|
12038865|NCT00294294|Biological|Infanrix hexa|
12038866|NCT00294281|Device|Vagus Nerve Stimulation (VNS) Therapy|The VNS Therapy System Pulse Generator is an implantable, multi-programmable bipolar pulse generator. The pulse generator will deliver electrical signals to the vagus nerve via bipolar leads. A programming wand and software system enable non-invasive programming, functional assessments, interrogation, and data retrieval.
12038867|NCT00294268|Behavioral|cognitive behavioural therapy|20 weekly sessions of CBT integrated with motivational enhancement strategies
12038868|NCT00294255|Drug|Risperidone|risperidone will be administered 1-3mg pills, each night, for up to 20 weeks
12038869|NCT00294242|Procedure|membrane sweeping|
12038870|NCT00294229|Procedure|manipulative therapy|
12038871|NCT00294216|Drug|Omega-3-acid ethyl ester 90 (n-3 PUFA)|
12038872|NCT00294203|Drug|Epoetin Alfa group|Patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.
12038873|NCT00294203|Other|Placebo group|Patients enrolled in the study will be randomized to receive either 40,000 units of placebo (saline) on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.
12038874|NCT00294190|Drug|Topotecan|Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
12038875|NCT00294177|Device|atomic force microscopy|
12038876|NCT00294177|Device|dual polarisation interferometry|
12038877|NCT00294164|Drug|Serostim®|Serostim® will be administered subcutaneously (daily or given on alternate days with matched placebo), at a dose based on body weight measured at Baseline, with a maximum daily dose of 4 mg up to Week 24.
12038878|NCT00294164|Drug|Placebo|Matching placebo will be administered subcutaneously (daily or given on alternate days with Serostim®), up to Week 24.
12038879|NCT00294151|Procedure|Vertebroplasty|
12038880|NCT00294125|Drug|Flavocoxid|Daily flavocoxid for 12 weeks
12038881|NCT00294125|Drug|Placebo|Daily placebo for 12 weeks
12038882|NCT00294112|Drug|Prochymal™ adult human mesenchymal stem cells|Cells in plasmalyte and containing dimethylsulfoxide
12038883|NCT00294112|Drug|adult human mesenchymal stem cells|two infusions, one week apart, each comprising adult human mesenchymal stem cells
12038884|NCT00294099|Biological|Aluminum hydroxide|Aluminum hydroxide adjuvant.
12038885|NCT00294099|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|Inactivated monovalent subvirion influenza H5N1 vaccine. Supplied in 0.5 mL unit dose vials as a sterile solution for IM injection. Dosages: 45 mcg, 15 mcg, 7.5, mcg, or 3.75 mcg administered with or without aluminum hydroxide adjuvant on Days 0 and 28.
12038886|NCT00294086|Drug|valsartan 160 mg|
12038887|NCT00294086|Drug|valsartan 160 mg BID|
12038888|NCT00294073|Procedure|Fascia Iliaca Block|
12038889|NCT00294073|Procedure|Femoral Block (with stimulating catheter)|
12038890|NCT00294073|Procedure|Femoral Block (without stimulating catheter)|
12038891|NCT00294047|Biological|Cervarix|Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
12038892|NCT00294047|Biological|Placebo control|Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
12038893|NCT00294034|Device|Pacemaker|
12038894|NCT00294008|Drug|Risperdal Consta|flexible dosage for 24 months
12038895|NCT00293995|Procedure|Laparaoscopic repair, with closure of contralateral patent processus vaginalis|
12038896|NCT00293995|Procedure|open repair|
12038897|NCT00293982|Behavioral|Physician knowledge of parental expectations for the visit|
12038898|NCT00293969|Drug|Morphine 0.1mg/kg versus morphine 0.15 mg/kg|
12038899|NCT00293943|Procedure|Pulmonary vein ablation|
12038900|NCT00293930|Drug|Tacrolimus|
12038901|NCT00293917|Drug|Tacrolimus Cream|
12038902|NCT00293904|Biological|CYT005-AllQbG10|
12038903|NCT00293891|Drug|Tacrolimus Cream|
12038904|NCT00293878|Drug|Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)|
12038905|NCT00293865|Procedure|sentinel node|detection of the sentinel node in breast cancer
12038906|NCT00293865|Procedure|GAS|
12038907|NCT00293852|Procedure|Outpatient clinic follow-up|
12038908|NCT00293839|Drug|oxybutynin chloride|
12038909|NCT00293826|Drug|AMG 108|50mg via SC (subcutaneous) injection every 4 weeks
12038910|NCT00293826|Drug|AMG 108|250mg via SC (subcutaneous) injection every 4 weeks
12038911|NCT00293826|Drug|AMG 108|125mg via SC (subcutaneous) injection every 4 weeks
12038912|NCT00293826|Drug|Placebo|Placebo via SC (subcutaneous) injection every 4 weeks
12038913|NCT00293813|Drug|Alendronate|Alendronate 70 mg PO QW
12038914|NCT00293813|Drug|Denosumab|denosumab 60 mg SC q 6 mos
12038915|NCT00293813|Drug|Placebo|Placebo for alendronate and placebo for denosumab
12038916|NCT00293800|Drug|Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12038918|NCT00293800|Drug|Timolol 0.5% Ophthalmic Solution|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
12038919|NCT00293800|Other|Timolol Vehicle|Placebo
12038920|NCT00293787|Drug|Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12038921|NCT00293787|Other|Timolol Vehicle|Placebo
12038922|NCT00293787|Drug|Latanoprost 0.005% Ophthalmic Solution (XALATAN)|Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
12038923|NCT00293787|Drug|Timolol Maleate Ophthalmic Solution 0.5%|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
12038924|NCT00293761|Drug|Travoprost, Investigational|One drop in study eye once daily for 13 days
12038925|NCT00293761|Drug|Travoprost (TRAVATAN)|One drop in study eye once daily for 13 days
12038926|NCT00293735|Drug|labetalol (seizure prevention)|"20mg IV (can be increased to an escalating dose of maximum of 80 mg (20mg, 40 mg, 80 mg q 20min) Cumulative max of 240 mg.
~20mg labetalol PO every 6 hours"
12038927|NCT00293735|Drug|MgSO4 (seizure prevention)|4-6g bolus over 20 minutes; 1-2 grams/hr Discontinued 24 hours after delivery.
12038928|NCT00293722|Drug|Etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
12038929|NCT00293709|Drug|etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
12038930|NCT00293696|Drug|bicalutamide (Casodex), goserelin (Zoladex)|
12038931|NCT00293683|Device|Insorb absorbable skin staple|
12038932|NCT00293670|Drug|Goserelin (Zoladex)|
12038933|NCT00293657|Drug|Lornoxicam 8 mg|
12038934|NCT00293657|Drug|Lornoxicam 16 mg|
12038935|NCT00293657|Drug|Placebo|
12038936|NCT00293644|Drug|Diclectin®|Participants will begin with an initial dose of 20mg (2 tablets), taken at bedtime. The dose of Diclectin® will be adjusted to match symptoms.
12038937|NCT00293631|Drug|Lornoxicam 8 mg|
12038938|NCT00293631|Drug|Lornoxicam 16 mg|
12038939|NCT00293631|Drug|Ketorolac 30 mg|
12038940|NCT00293631|Drug|Placebo|
12038941|NCT00293618|Device|Automatic Risk Presentation in the operating room|Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure
12038942|NCT00293618|Other|Education|Specific information is provided to the intervention group: about PONV, about the prediction model. While the Usual Care group only receives information about the study purposes
12038943|NCT00293618|Other|Feedback|Feedback about the physician's personal performance on prevention of PONV
12038944|NCT00293605|Procedure|Total Hip Replacement|Implantation of one of 3 stem designs
12038945|NCT00293592|Drug|Dexamethasone|1 mg per kg as a single dose before initiation of cardiopulmonary bypass
12038946|NCT00293579|Drug|Pemetrexed|500 mg/m2 IV every 3 weeks for 6 cycles
12038947|NCT00293553|Procedure|Electronic Barostat|
12038948|NCT00293540|Procedure|oophorectomy|Excision of an ovary
12038949|NCT00293540|Drug|Tamoxifen|20 mg orally every day
12038950|NCT00293527|Drug|Interferon Alpha-2b|
12038951|NCT00293514|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|
12038952|NCT00293501|Drug|tinzaparin sodium|
12038953|NCT00293488|Drug|polyamine analogue PG11047|
12038954|NCT00293475|Drug|Carboplatin|Given IA
12038955|NCT00293475|Drug|Mannitol|Given IA
12038956|NCT00293475|Drug|Methotrexate|Given IA
12038957|NCT00293475|Other|Quality-of-Life Assessment|Ancillary studies
12038958|NCT00293475|Biological|Rituximab|Given IV
12038959|NCT00293475|Drug|Sodium Thiosulfate|Given IV
12038960|NCT00293462|Biological|sargramostim|
12038961|NCT00293462|Other|oral salt and soda mouthwash|Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.
12038962|NCT00293436|Drug|celecoxib|
12038963|NCT00293436|Drug|erlotinib hydrochloride|
12038964|NCT00293436|Procedure|adjuvant therapy|
12038965|NCT00293423|Biological|HSPPC-96|25 mcg ID
12038966|NCT00293423|Procedure|conventional surgery|craniotomy
12038967|NCT00293410|Drug|clofarabine|
12038968|NCT00293410|Drug|cyclophosphamide|
12038969|NCT00293397|Device|Drug-eluting beads loaded with doxorubicin hydrochloride|Doxorubicin eluting beads
12038970|NCT00293384|Drug|Aprepitant|Aprepitant 80mg once daily in the morning on days 2 and 3
12038971|NCT00293384|Drug|Cyclophosphamide|Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
12038972|NCT00293384|Drug|Dexamethasone|Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
12038973|NCT00293384|Drug|Granisetron hydrochloride|Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
12038974|NCT00293371|Drug|docetaxel|
12038975|NCT00293371|Drug|prednisone|
12038976|NCT00293371|Drug|vatalanib|
12038977|NCT00293358|Drug|carboplatin|
12038978|NCT00293358|Drug|cisplatin|
12038979|NCT00293358|Drug|etoposide phosphate|
12038980|NCT00293358|Drug|ifosfamide|
12038981|NCT00293358|Procedure|adjuvant therapy|
12038982|NCT00293358|Procedure|conventional surgery|
12038983|NCT00293358|Procedure|neoadjuvant therapy|
12038984|NCT00293358|Radiation|radiation therapy|
12038985|NCT00293345|Drug|gemcitabine hydrochloride|
12038986|NCT00293345|Drug|triapine|
12038987|NCT00293332|Biological|bevacizumab|Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.
12038988|NCT00293332|Drug|carboplatin|Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.
12038989|NCT00293332|Drug|docetaxel|Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.
12039035|NCT00292929|Drug|Intravenous artesunate|
12039036|NCT00292916|Behavioral|whole body vibration|
12039037|NCT00292916|Behavioral|resistance exercise|
12038990|NCT00293332|Procedure|conventional surgery|Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.
12038991|NCT00293319|Biological|filgrastim|
12038992|NCT00293319|Radiation|iobenguane I 131|
12038993|NCT00293293|Other|healing touch|The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.
12038994|NCT00293293|Other|massage therapy|Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.
12038995|NCT00293293|Other|hypnosis|Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.
12038996|NCT00293293|Drug|Standard chemotherapy|Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
12038997|NCT00293280|Drug|lomustine|
12038998|NCT00293267|Drug|raltegravir potassium|Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
12038999|NCT00293267|Drug|Comparator: Placebo|Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.
12039000|NCT00293254|Drug|raltegravir potassium|Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
12039001|NCT00293254|Drug|Comparator: placebo|Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.
12039002|NCT00293241|Device|Managed Ventricular Pacing programmed ON/OFF|Device programming
12039003|NCT00293228|Drug|Isoniazid|Isoniazid (5mg per kg up to 300 mg daily for 6 months)
12039004|NCT00293228|Drug|isoniazid|isoniazid (5mg per kg up to 300 mg daily for 6 months
12039005|NCT00293215|Drug|111-Indium-CMD-193|111-In-CMD-193 (3-7 mCi) was administered as an IV infusion over 60 (± 5) minutes.
12039006|NCT00293215|Drug|CMD-193|CMD-193 was administered as an IV infusion over 60 (± 5) minutes.
12039007|NCT00293202|Drug|Etanercept|Hemodialysis patients having a serum albumin of less than or equal to 3.8 g/dl and a CRP greater than or equal to 0.8 mg/dL will receive either etanercept at a dose of 25 mg by subcutaneous injection twice a week or a placebo for a period of 48 weeks. The outcome is an increase in serum albumin and pre-albumin in the treated group.
12039008|NCT00293202|Drug|Saline|Saline will be injected subcutaneously twice a week
12039009|NCT00293176|Drug|Donepezil Hydrochloride|Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.
12039010|NCT00293176|Drug|Placebo|Subjects will receive matching placebo tablets.
12039011|NCT00293163|Device|Hylaform, Hylaform Plus (hylan B gel)|
12039012|NCT00293150|Drug|Eplerenone|
12039013|NCT00293124|Drug|Glivec|400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing
12039014|NCT00293111|Drug|SDX-101 (R-Etodolac)|
12039015|NCT00293098|Drug|deferiprone|oral administration of 75 mg/kg/day in three divided doses, usually in combination with deferoxamine therapy
12039016|NCT00293085|Drug|Docetaxel|
12039017|NCT00293085|Drug|Docetaxel|"Docetaxel (Taxotere) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles.
~Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities.
~Premedication:
~Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion.
~All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion.
~Hyperhydration Patients will require intravenous hydration according to institutional guidelines."
12039018|NCT00293072|Drug|Rituximab|
12039019|NCT00293059|Drug|Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle)
12039020|NCT00293059|Drug|Placebo|Matching placebo to be taken orally daily.
12039021|NCT00293046|Biological|ALK Grass tablet - use of compliance device|
12039022|NCT00293033|Drug|BEMA™|BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.
12039023|NCT00293033|Drug|Placebo|
12039024|NCT00293020|Drug|BEMA Fentanyl|buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily
12039025|NCT00292994|Behavioral|Exercise|
12039026|NCT00292994|Behavioral|Weight Loss|
12039027|NCT00292981|Drug|C1 Esterase Inhibitor|Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv
12039028|NCT00292968|Behavioral|Computer based care|
12039029|NCT00292968|Behavioral|Telephone counseling|
12039030|NCT00292968|Behavioral|Group visits|
12039031|NCT00292968|Behavioral|Usual care|
12039032|NCT00292955|Drug|Cetuximab|monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.
12039033|NCT00292942|Drug|Intravenous Artesunate|Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)
12039034|NCT00292942|Drug|Placebo|Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight.
12039039|NCT00292903|Behavioral|Brief interpersonal psychotherapy|IPT-B sessions include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment.
12039040|NCT00292903|Behavioral|Facilitated referral for treatment as usual|F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.
12039041|NCT00292890|Device|insulin needle|
12039042|NCT00292877|Drug|SB-240563 (Mepolizumab)|
12039043|NCT00292864|Drug|SNS-032 Injection|
12039044|NCT00292838|Drug|fluticasone 25, 50, 100, 200 mcg|
12039045|NCT00292825|Device|Pacemaker treatment, pacemaker programmed as active = CLS|Pacemaker treatment with closed loop function(CLS)
12039046|NCT00292825|Device|Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)|pacemaker treatment as VVI 30 bpm
12039047|NCT00292812|Drug|Nutritional supplementation (nucleotides)|
12039048|NCT00292799|Drug|Orlistat Vs Metformin|
12039049|NCT00292786|Behavioral|Walking Practice with Functional Electrical Stimulation|
12039050|NCT00292786|Behavioral|Walking Practice|
12039051|NCT00292773|Procedure|weight reduction minimal access surgery|Patients will be offered laparoscopic gastric bypass surgery by Mr Roger Ackroyd, in line with the current recommendation for gastric surgery according to NICE guidelines i.e. patients with a BMI over 40 or a BMI over 35 with at least one co-morbidity. Patients will be reviewed monthly for six months.
12039052|NCT00292760|Drug|Alemtuzumab|
12039053|NCT00292760|Drug|Methyprednisolone|
12039054|NCT00292747|Drug|Drotaverine|
12039055|NCT00292747|Drug|Drotaverine Placebo|
12039056|NCT00292747|Drug|Ibuprofen|
12039057|NCT00292747|Drug|Ibuprofen Placebo|
12039058|NCT00292734|Drug|Zolpidem|
12039059|NCT00292721|Drug|Celecoxib|celecoxib: loading and maintenance for 6 months
12039060|NCT00292708|Drug|Cefmetazole (drug)|
12039061|NCT00292695|Other|VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT|"IF-RT 50.4 Gy/28 Fractions, DEP: (Q4W, CCRT) X 2 Dexamethosone 20 mg/m2/d iv D1-3 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-3 Cisplatin 75 mg/m2 ivd 4 hr D1
~DVIP: (Q4W, POST-RT) X 2 Dexamethosone 20 mg/m2/d iv D1-4 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-4 Ifosfamide 1.2 gm/m2/d ivd 2 hr D1-4 Mesna 240 mg/m2/d iv at 0, 4, 8 hr D1-4 Cisplatin 20 mg/m2 ivd 1 hr D1-4 G-CSF 250ug subcut D 9-12"
12039062|NCT00292656|Procedure|NAET|
12039063|NCT00292591|Drug|cholecalciferol (vitamin D3)|randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
12039064|NCT00292591|Drug|cholecalciferol|comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
12039065|NCT00292578|Procedure|NAET Testing Modalities|
12039066|NCT00292552|Other|Novel endpoint determination|Novel endpoint determination
12039067|NCT00292539|Device|Any pacemaker with right ventricular pacing option|
12039068|NCT00292526|Drug|Enalapril|enalapril orally administered
12039069|NCT00292513|Device|standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)|
12039070|NCT00292500|Device|Automated distal anastomotic device|CABG
12039071|NCT00292487|Drug|Iopamidol 370 mgI/mL|
12039072|NCT00292474|Device|percutaneous coronary intervention|
12039073|NCT00292461|Drug|Zonisamide|Tablet once or twice daily orally for 16 weeks
12039074|NCT00292461|Drug|Lamotrigine|Tablet once daily orally for 16 weeks
12039075|NCT00292448|Drug|Ba 679 BR Respimat|
12039076|NCT00292448|Drug|Tiotropium (Spiriva) inhalation capsule 18 ug|
12039077|NCT00292435|Drug|Read vine leaf extract (AS 195)|
12039078|NCT00292422|Drug|BG9924|
12039079|NCT00292409|Drug|Aripiprazole|
12039080|NCT00292396|Drug|Anti IL-12 monoclonal antibody/ABT-874|Please see Arm Description for intervention description and details.
12039081|NCT00292396|Drug|placebo|12 doses
12039082|NCT00292383|Procedure|Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR|
12039083|NCT00292370|Drug|Open Label (OL) Paroxetine|Open-label Paroxetine
12039084|NCT00292370|Drug|Placebo|Double-blind placebo taken with OL paroxetine
12039085|NCT00292370|Drug|Quetiapine|Double-blind quetiapine taken with OL paroxetine
12039086|NCT00292357|Procedure|Application of autologous bone marrow|
12039087|NCT00292344|Drug|Rifaximin and loperamide|
12039088|NCT00292331|Procedure|cyanoacrylate injection to treat gastric variceal hemorrhage|
12039089|NCT00292318|Behavioral|Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study|Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.
12039090|NCT00292318|Behavioral|control group|Medical counseling and ano-sphinctal exercises.
12039091|NCT00292305|Procedure|Percutaneous coronary intervention|Implantation of coronary stent in bifurcation lesions
12039092|NCT00292292|Device|Lumbar Artificial Disc|Insertion of the Kineflex Lumbar ArtificialDisc
12039093|NCT00292292|Device|Charite Artificial Disc|Insertion of the Charite
12039094|NCT00292279|Drug|Omega-3 fish oil emulsion (Omegaven )|Patients of the treatment group received 0.2 g fish oil (10% Omegaven, Fresenius Kabi, Bad Homburg, Germany) and 1.0 g soy bean oil per kg BW per day
12039095|NCT00292279|Drug|long-chain triglyceride|the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
12039096|NCT00292266|Drug|Rebif®|Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.
12039097|NCT00292266|Drug|Avonex®|Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.
12039098|NCT00292253|Device|Rebif® via Rebiject™Mini|Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.
12039099|NCT00292253|Device|Rebif® via manual injections|Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.
12039100|NCT00292240|Behavioral|Brief motivational substance use intervention|
12039101|NCT00292227|Drug|Rotigotine|"Rotigotine patch applied once daily for a 24-hour period.
~Rotigotine dose schedule (patch application days):
~Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;"
12039102|NCT00292227|Other|Placebo|"Placebo patch applied once daily for a 24-hour period. Size and number of patches matching to rotigotine dose schedule (patch application days):
~Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;"
12039103|NCT00292227|Drug|Moxifloxacin infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39
12039104|NCT00292227|Other|Placebo infusion|Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39
12039105|NCT00292227|Other|Placebo infusion|Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39
12039106|NCT00292214|Drug|Paracetamol (acetaminophen)|
12039107|NCT00292201|Drug|Atorvastatin|The treatment group will receive Atorvastatin 80 mg po once per day for 4 weeks. The placebo group will receive an identical placebo pill po once per day for 4 weeks.
12039108|NCT00292188|Drug|pregabalin|pregabalin
12039109|NCT00292188|Drug|Placebo|placebo
12039110|NCT00292175|Procedure|Narrow Band Imaging|
12039111|NCT00292175|Procedure|colonoscopy|
12039112|NCT00292162|Procedure|radiofrequency ablation|isolation of the pulmonary veins with radiofrequency ablation (RFA)
12039113|NCT00292162|Drug|ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril|Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.
12039114|NCT00292162|Drug|Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol|Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.
12039115|NCT00292162|Drug|Aldosterone Antagonists - spironolactone|Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.
12039116|NCT00292123|Drug|Methadone|
12039117|NCT00292123|Behavioral|Contingency Management|
12039118|NCT00292110|Drug|Methadone|100 mg/day orally
12039119|NCT00292110|Behavioral|Contingency Management|Incentives given for cocaine abstinence
12039120|NCT00292110|Drug|Methadone dose|flexible methadone dosing to 190 mg/day daily orally
12039121|NCT00292110|Behavioral|Contingency Management/Noncontingent Incentives|Incentives given independent of drug use
12039122|NCT00292097|Procedure|Early tracheostomy|early conversion - less than or equal to 72 hours
12039123|NCT00292097|Procedure|Late tracheostomy|Late conversion (10-14 days)
12039124|NCT00292084|Drug|Celgosivir|
12039125|NCT00292071|Drug|caspofungin acetate|(50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
12039126|NCT00292058|Device|Videoconference equipment (telepsychiatry)|
12039127|NCT00292045|Biological|NY-ESO-1 protein/CpG|
12039128|NCT00292019|Procedure|Laparoscopic|Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.
12039129|NCT00292006|Device|Computerized tomography|
12039130|NCT00291980|Biological|HB-AS02V vaccine|HB-AS02V (20µg HBsAg) will be administered at Month 0
12039131|NCT00291980|Biological|HBVAXPRO vaccine|HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0
12039132|NCT00291967|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
12039133|NCT00291954|Biological|HB-AS02V|HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
12039134|NCT00291954|Biological|HBVAXPRO vaccine|HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
12039135|NCT00291941|Biological|Henogen HBV vaccine|20µg, Month 0, 2 and 6
12039136|NCT00291941|Biological|FENDRIX|20 µg,Months 0, 1, 2 and 6
12039137|NCT00291928|Drug|Part A|Part A Cohort 1: HuMax-CD20 300 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 2: HuMax-CD20 700 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 3: HuMax-CD20 1000 mg at Days 0 and 14 or Placebo at Days 0 and 14
12039138|NCT00291928|Drug|Part B|Part B Group 1: HuMax-CD20 300 mg at Days 0 and 14 Group 2: HuMax-CD20 700 mg at Days 0 and 14 Group 3: HuMax-CD20 1000 mg at Days 0 and 14 Group 4: Placebo at Days 0 and 14
12039139|NCT00291915|Drug|Adalimumab|
12039140|NCT00291915|Drug|Methotrexate|
12039141|NCT00291902|Drug|SB-681323|
12039142|NCT00291889|Biological|Mtb72F/AS02.|
12039143|NCT00291876|Biological|Havrix™|2 doses at 12 months interval
12039144|NCT00291863|Drug|Simvastatin|
12039145|NCT00291850|Drug|Paclitaxel, Cisplatin, Pegfilgrastim|
12039146|NCT00291837|Drug|CT-2106|
12039147|NCT00291824|Behavioral|Cardiovascular risk factors and willingness to change|
12039148|NCT00291811|Drug|AMD3100 + G-CSF|Subcutaneous injection of 240 mcg/kg on the evening prior to each apheresis session
12039149|NCT00291798|Procedure|rate of remission|
12039150|NCT00291785|Drug|CT-2106|CT-2106 as 10 minute infusion on days 1, 15 & 29 of each 42-day cycle
12039151|NCT00291785|Drug|Folinic acid|Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
12039152|NCT00291785|Drug|5-FU (fluorouracil)|5-FU following CT-2106 and folinic acid infusions @ 400 mg/m² IV bolus then 5-FU 600 mg/m² as a 22 hour IV infusion on Days 1, 2, 15, 16, 29, and 30.
12039153|NCT00291772|Drug|Pramlintide|Basal and bolus pramlintide subcutaneous infusion
12039154|NCT00291759|Drug|Tamoxifen|
12039155|NCT00291759|Drug|Anastrozole|
12039156|NCT00291746|Drug|Esomeprazole|
12039157|NCT00291746|Procedure|Bravo technique|
12039158|NCT00291733|Drug|Levetiracetam|500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
12039159|NCT00291733|Drug|Placebo|Placebo tabl
12039160|NCT00291720|Drug|Spironolactone|All patients receive a 4 week open labeled run in phase of 25mg spironolactone daily after which they are randomized to continue or receive matched placebo for 8 months.
12039161|NCT00291720|Drug|Placebo|matching placebo
12039162|NCT00291707|Drug|Cetuximab|The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. The infusion rate of cetuximab must never exceed 5 mL/min.
12039163|NCT00291707|Drug|Pemetrexed|• Pemetrexed 350-500 mg/m2 IV over 10 minutes (see dose escalation design. Dose will be decreased to 200 mg/m2, if the first dose level of 350 mg/m2 is not tolerable) on days 1 and 22, (and 43 if >6000 cGy to be delivered)
12039164|NCT00291707|Procedure|radiation therapy|• Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1. Radiation will be given M-F for 6-7 consecutives weeks
12039165|NCT00291694|Drug|celecoxib|Celecoxib 400 mg BID
12039166|NCT00291694|Other|placebo|placebo
12039167|NCT00291668|Biological|Certolizumab Pegol|"Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 200 mg/mL
~Route of Administration: Subcutaneous use"
12039168|NCT00291668|Other|Placebo|"Active Substance: isotonic sodium chloride solution
~Pharmaceutical Form: Solution for injection
~Concentration: 1 mL
~Route of Administration: Subcutaneous use"
12039169|NCT00291655|Drug|Levetiracetam|500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
12039170|NCT00291642|Drug|Placebo drops|"Pharmaceutical form: Drops for oral administration
~Route of administration: Oral use"
12039171|NCT00291642|Drug|Placebo tablets matching to levocetirizine|"Pharmaceutical form: Tablets for oral administration
~Route of administration: Oral use"
12039172|NCT00291642|Drug|Placebo tablets matching to cetirizine|"Pharmaceutical form: Tablets for oral administration
~Route of administration: Oral use"
12039173|NCT00291642|Drug|Levocetirizine drops|"Pharmaceutical form: Drops for oral administration
~Concentration: 5 mg/ml
~Route of administration: Oral use"
12039174|NCT00291642|Drug|Levocetirizine tablets|"Pharmaceutical form: Tablets for oral administration
~Concentration: 5 mg
~Route of administration: Oral use"
12039175|NCT00291642|Drug|Cetirizine drops|"Pharmaceutical form: Drops for oral administration
~Concentration: 10 mg/ml
~Route of administration: Oral use"
12039176|NCT00291642|Drug|Cetirizine tablets|"Pharmaceutical form: Tablets for oral administration
~Concentration: 10 mg
~Route of administration: Oral use"
12039177|NCT00291629|Drug|G-CSF (Dong-A pharmaceutical, Seoul, Korea)|
12039178|NCT00291629|Procedure|collection of mobilized peripheral blood stem cells|
12039179|NCT00291629|Procedure|Intracoronary infusion of mobilized cells|
12039180|NCT00291616|Drug|Pegylated Interferon-alpha2a|180 microgram s.c. injection weekly
12039181|NCT00291616|Drug|Thymosin alpha1 & Pegylated Interferon-alpha2a|Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week
12039182|NCT00291603|Device|FX-class of dialyser|
12039183|NCT00291590|Behavioral|DHEP|
12039184|NCT00291577|Drug|Sunitinib (Sutent)|Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision
12039185|NCT00291577|Drug|Taxotere|Taxotere 75 mg/m2 iv, once every 3 weeks
12039186|NCT00291564|Device|Cardiac Resynchronization Therapy Device|
12039187|NCT00291551|Device|Placement of the PVSS Implant|Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.
12039188|NCT00291538|Drug|bortezomib|
12039189|NCT00291525|Device|On-X valve using reduced anticoagulation|Valve replacement with antiplatelet agents or lowered warfarin
12039190|NCT00291525|Device|On-X Valve with Standard warfarin Therapy|Valve replacement with standard dosage warfarin
12039191|NCT00291512|Behavioral|Theory-based counseling program|
12039192|NCT00291499|Drug|Chondroitin 4&6 sulfate (Condrosulf)|800 mg/day for 6 months
12039193|NCT00291499|Other|Placebo|800 mg placebo/day for 6 months
12039194|NCT00291486|Drug|Capecitabine|Capecitabine will be administered at doses between 1000 and 1250 mg/m2/day depending on assigned dose level for 14 days per 21 day cycle. Daily doses may be rounded to the nearest 150mg.
12039195|NCT00291486|Drug|131I-huA33 (131-Iodine on humanised monoclonal antibody A33)|All patients will receive a scout dose of 5 mg huA33 conjugated to 5-8 mCi 131I. The therapy dose of 131I-huA33 will comprise a constant protein dose of 10 mg/m2 huA33 regardless of dose level. The 131I therapy dose will be determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
12039196|NCT00291473|Drug|CHP-HER2, CHP-NY-ESO-1|
12039197|NCT00291460|Device|inspiratory muscle training|
12039198|NCT00291447|Drug|ch806|
12039199|NCT00291447|Drug|111-Indium-ch806|
12039200|NCT00291408|Procedure|Skin Prick Test|
12039201|NCT00291408|Procedure|Impulse Oscillometry|
12039202|NCT00291408|Procedure|Exhaled Nitric Oxide|
12039203|NCT00291408|Procedure|Spirometry|
12039204|NCT00291408|Procedure|Reversibility|
12039205|NCT00291408|Procedure|Exhaled Breath Condensate|
12039206|NCT00291408|Procedure|Sputum Induction|
12039207|NCT00291395|Drug|PGI2|
12039208|NCT00291382|Drug|Salmeterol/fluticasone propionate combination|
12039209|NCT00291369|Drug|Interleukin-2|
12039210|NCT00291369|Drug|Interferon alfa|
12039211|NCT00291369|Drug|medroxyprogesterone acetate|
12039212|NCT00291356|Drug|GSK189075 oral tablets|
12039213|NCT00291356|Drug|GW869682 oral tablets|
12039214|NCT00291343|Biological|Tritanrix™- HepB|One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
12039215|NCT00291343|Biological|Hiberix™|One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
12039216|NCT00291343|Biological|Mencevax™ ACWY|One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
12039217|NCT00291330|Drug|dabigatran etexilate 150 mg|twice daily
12039218|NCT00291330|Drug|warfarin (INR 2-3)|prn to maintain INR (2-3)
12039283|NCT00290693|Drug|Docetaxel|30 mg/m2, IV, days 1 and 8 every 3 weeks
12039284|NCT00290680|Drug|bortezomib|
12039219|NCT00291317|Device|RT 300-P FES Cycle|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD). Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes per session over a 9 month period. The intervention was provided at Children's Specialized Hospital in Mountainside, and families were required to provide their own transportation. During the study, the participants continued to participate in their standard, primary rehabilitation program.
12039220|NCT00291304|Procedure|MRI|pre-surgery
12039221|NCT00291239|Behavioral|partial sleep deprivation|
12039222|NCT00291226|Drug|Glycine|Glycine 0.4 g/kg bid
12039223|NCT00291226|Drug|Placebo|Placebo
12039224|NCT00291213|Drug|levetiracetam|
12039225|NCT00291213|Drug|placebo|
12039226|NCT00291187|Drug|20 mg VEC-162|20 mg VEC-162
12039227|NCT00291187|Drug|50 mg VEC-162|50 mg VEC-162
12039228|NCT00291187|Drug|100 mg VEC-162|100 mg VEC-162
12039229|NCT00291187|Drug|Placebo|Placebo
12039230|NCT00291161|Behavioral|Partners in Dementia Care|"Partners in Dementia Care is facilitated by the VA Dementia care coordinator (VA DCC) that is with the study. The role of the VA DCC includes conducting initial assessments with the subject and caregiver that leads to:
~Arranging for further assessment or attention from VA health care system/providers about dementia related concerns or about co-morbid health issues; for example: VA driving evaluation, congestive heart failure medication adherence; Ensuring education is provided about particular health, safety issues; Following up with patient/caregiver on health promoting activities he/she is committed to do; and Sharing care plan actions/outcomes with other VA providers as agreed upon by patient."
12039231|NCT00291148|Drug|paroxetine|
12039232|NCT00291148|Drug|pregabalin|
12039233|NCT00291135|Drug|letrozole|Letrozole 2.5 mg daily
12039234|NCT00291122|Drug|celecoxib 400 mg BID|
12039235|NCT00291109|Drug|letrozole 2.5 mg|
12039236|NCT00291070|Drug|L-theanine|This study will examine the effects of L-theanine (an amino acid found in green tea) on the behavior, cognitive performance and sleep quality of boys with ADHD.
12039237|NCT00291057|Drug|MALG|30 minute application
12039238|NCT00291044|Other|testing for HSV 1 and 2 IgG type specific antibosy|
12039239|NCT00291031|Behavioral|Imagery Rehearsal Therapy (IRT)|"Imagery Rehearsal Therapy is given by psychologists, psychotherapists or psychiatrists. The IRT therapists are all trained by Annette van Schagen, principal investigator.
~IRT consists of six 1-hour sessions. The six sessions are given in a period of three months. Each session is described in the IRT Manual. The IRT Manual is devised by the principal investigator Annette van Schagen in colaboration with Victor Spoormaker PhD. There is a patient version of the IRT manual available for the patients, which includes descriptions of the IRT sessions and homework assignments."
12039240|NCT00291018|Device|Total Disc Replacement|Total Disc Replacement using ProDisc-C
12039241|NCT00291018|Device|ACDF|Anterior Cervical Discectomy and Fusion
12039242|NCT00291005|Drug|ARD6562, Docetaxel|
12039243|NCT00290992|Drug|rasburicase (SR29142)|
12039244|NCT00290979|Drug|insulin glulisine|
12039245|NCT00290966|Drug|XRP6976|
12039246|NCT00290953|Drug|SR48692|
12039247|NCT00290940|Drug|CS-917|
12039248|NCT00290940|Drug|metformin hydrochloride|
12039249|NCT00290940|Drug|pioglitazone|
12039250|NCT00290927|Drug|insulin glulisine|
12039251|NCT00290914|Drug|Vilazodone|
12039252|NCT00290901|Drug|Tramadol Hydrochloride 50mg|
12039253|NCT00290901|Drug|Celebrex 200mg|
12039254|NCT00290888|Procedure|Acromioplasty|
12039255|NCT00290875|Behavioral|Use of Xrays for diagnosis|
12039256|NCT00290862|Device|Percutaneous Vertebral Augmentation of compression fractures|Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group).
12039257|NCT00290849|Drug|Bivalirudin|
12039258|NCT00290836|Drug|Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)|
12039259|NCT00290823|Drug|Albendazole|400 mg tablet taken orally twice daily
12039260|NCT00290823|Drug|Dexamethasone|6mg or 8mg taken daily
12039261|NCT00290823|Drug|Omeprazole|20 mg tablet taken orally daily
12039262|NCT00290810|Biological|bevacizumab|Given IV
12039263|NCT00290771|Drug|Imatinib tablets|Imatinib was supplied as 100 and 400 mg tablets by Novartis.
12039264|NCT00290771|Drug|Hydroxyurea capsules|Hydroxyurea was supplied locally as 500 mg capsules.
12039265|NCT00290758|Drug|placebo|Given orally
12039266|NCT00290758|Drug|genistein|Given orally
12039267|NCT00290758|Other|laboratory biomarker analysis|Correlative studies
12039268|NCT00290745|Drug|letrozole|
12039269|NCT00290745|Drug|tamoxifen citrate|
12039270|NCT00290745|Procedure|conventional surgery|
12039271|NCT00290745|Procedure|neoadjuvant therapy|
12039272|NCT00290732|Drug|Intraductal arm|Patients will receive PLD intraductally according to the dose escalation schema (Dose Level -1=1 mg, Dose Level 1=2 mg, Dose Level 2= 5mg, Dose Level 3=10 mg). The PLD dose will be diluted in 5% dextrose in water and will be mixed for a total volume of 5 ml. The PLD will be administered via a breast duct (i.e., intraductally) using a microcatheter
12039273|NCT00290732|Drug|Intravenous arm|Blood samples and a breast tissue biopsy collected to look at levels of doxorubincol from patients receiving intravenous pegylated liposomal doxorubin to compare to the group receiving drug intraductally.
12039274|NCT00290719|Drug|cisplatin|
12039275|NCT00290719|Drug|gefitinib|
12039276|NCT00290719|Drug|irinotecan hydrochloride|
12039277|NCT00290719|Procedure|conventional surgery|
12039278|NCT00290719|Procedure|neoadjuvant therapy|
12039279|NCT00290719|Radiation|radiation therapy|
12039280|NCT00290706|Drug|bortezomib|Bortezomib 1.6mg/m2 on days 1 and 15 of each cycle, given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.
12039281|NCT00290706|Drug|gemcitabine hydrochloride|Gemcitabine dose of 800 mg/m2 over 30 minutes on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.
12039282|NCT00290693|Drug|Capecitabine|Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
12039286|NCT00290667|Biological|pegfilgrastim|
12039287|NCT00290667|Biological|rituximab|
12039288|NCT00290667|Drug|cyclophosphamide|
12039289|NCT00290667|Drug|doxorubicin hydrochloride|
12039290|NCT00290667|Drug|prednisone|
12039291|NCT00290667|Drug|vincristine sulfate|
12039292|NCT00290667|Other|pharmacological study|
12039293|NCT00290667|Radiation|radiation therapy|
12039294|NCT00290654|Drug|Tamoxifen|Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
12039295|NCT00290654|Procedure|Lumpectomy|A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
12039296|NCT00290654|Radiation|brachytherapy|Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.
12039297|NCT00290641|Biological|filgrastim|
12039298|NCT00290641|Biological|graft-versus-tumor induction therapy|
12039299|NCT00290641|Drug|cyclophosphamide|
12039300|NCT00290641|Drug|cyclosporine|
12039301|NCT00290641|Drug|fludarabine phosphate|
12039302|NCT00290641|Drug|mycophenolate mofetil|
12039303|NCT00290641|Procedure|umbilical cord blood transplantation|
12039304|NCT00290641|Radiation|radiation therapy|
12039305|NCT00290628|Drug|anti-thymocyte globulin|
12039306|NCT00290628|Drug|busulfan|
12039307|NCT00290628|Drug|cyclophosphamide|
12039308|NCT00290628|Drug|cyclosporine|
12039309|NCT00290628|Drug|filgrastim|
12039310|NCT00290628|Drug|melphalan|
12039311|NCT00290628|Drug|methylprednisolone|
12039312|NCT00290628|Drug|mycophenolate mofetil|
12039313|NCT00290628|Procedure|radiation therapy|
12039314|NCT00290628|Procedure|umbilical cord blood transplantation|
12039315|NCT00290615|Biological|bevacizumab|
12039316|NCT00290615|Biological|cetuximab|
12039317|NCT00290615|Drug|capecitabine|
12039318|NCT00290615|Drug|oxaliplatin|
12039319|NCT00290602|Drug|Methylprednisolone sodium succinate|
12039320|NCT00290589|Drug|Intramuscular methylprednisolone acetate|Intramuscular methylprednisolone acetate 160mg
12039321|NCT00290589|Drug|Placebo|Normal saline intramuscular injection
12039322|NCT00290576|Dietary Supplement|Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )|
12039323|NCT00290563|Drug|MK0594|
12039324|NCT00290550|Drug|MK0457|IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days
12039325|NCT00290537|Drug|ZD6474|ZD6474 alone: Cycles 1-3 = 300 mg PO Daily x 3 Weeks; ZD6474+Carboplatin+Paclitaxel = 300 mg oral (PO) Daily or 100 mg PO Daily plus Carboplatin and Paclitaxel Every 3 Weeks.
12039326|NCT00290537|Drug|Carboplatin|6 AUC IV Over 15-30 Minutes, Immediately After Paclitaxel
12039327|NCT00290537|Drug|Paclitaxel|200 mg/m^2 IV Over 3 Hours On Day 1
12039328|NCT00290524|Behavioral|Oral alimentation started 12 hours after colorectal surgery|
12039329|NCT00290511|Drug|Fludarabine|25 mg/m^2 intravenous (IV) over 5-30 minutes on Days 2-4.
12039330|NCT00290511|Drug|Mitoxantrone|10 mg/m^2 IV over 5-30 minutes on Day 2.
12039331|NCT00290511|Drug|Rituximab|375 mg/m^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total).
12039332|NCT00290511|Drug|Zevalin|0.3 mCi/kg IV after 4 cycles of R-FND.
12039333|NCT00290511|Drug|Dexamethasone|20 mg by mouth (PO) or IV daily on Days 2-6.
12039334|NCT00290498|Drug|Rituximab|Arm A: Rituximab 375 mg/m² by vein on day 1, Cycle 1 and alternating cycles. Arm B: Rituximab 375 mg/m² on day 1, Cycle 2 and alternating cycles.
12039335|NCT00290498|Drug|Cyclophosphamide|"Arm A: Cyclophosphamide 300 mg/m^2 by vein (IVPB) over 3 hours every 12 hours x 6 doses on Days 2-4, Cycle 1 and alternating cycles.
~Arm B: Cyclophosphamide 750 mg/m² by vein day 1"
12039336|NCT00290498|Drug|Doxorubicin|Arm A: Doxorubicin 50 mg/m^2/day by vein over 15 minutes (12 hours after last dose of cyclophosphamide) on Day 5, Cycle 1 and alternating cycles.
12039337|NCT00290498|Drug|Vincristine|"Arm A: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12, Cycle 1 and alternating cycles.
~Arm B: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12 of each cycle."
12039338|NCT00290498|Drug|Dexamethasone|Arm A: Dexamethasone 40 mg by vein or by mouth daily x 4 on Days 2-5 and on days 12-15 of cycle 1 and alternating cycles.
12039339|NCT00290498|Drug|Methotrexate|Arm A: Methotrexate after finishing Rituximab, 200 mg/m2 by vein over 2 hours, then 800 mg/m2 by vein over 22 hours day 1 cycle 2.
12039340|NCT00290498|Drug|Cytarabine|Arm B: Cytarabine 3 g/m^2 by vein over 2 hours every 12 hours X 4 doses on days 3 & 4, cycle 2 and alternating cycles.
12039341|NCT00290498|Drug|Prednisone|Arm B: Prednisone 100 mg by mouth (as a pill, capsule, or tablet) once a day on Days 1-5, each cycle.
12039342|NCT00290485|Drug|Imatinib mesylate|
12039343|NCT00290472|Drug|temsirolimus|
12039344|NCT00290433|Drug|Cyclophosphamide|Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.
12039345|NCT00290433|Drug|Mesna|Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3.
12039346|NCT00290433|Drug|Vincristine|Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11.
12039347|NCT00290433|Drug|Methotrexate|Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1.
12039348|NCT00290433|Drug|Ara-C|Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3.
12039349|NCT00290433|Drug|Dexamethasone|Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.
12039350|NCT00290433|Drug|G-CSF|Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.
12039351|NCT00290433|Drug|Doxil|Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2.
12039352|NCT00290420|Drug|Chloroquine profilaxis|"Prevention:
~Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes"
12039353|NCT00290407|Drug|Rituximab|375 mg/m2, IV (in the vein), once a week for 4 weeks
12039354|NCT00290407|Dietary Supplement|Beta-Glucan|250 mg, orally (tablet), three times a day for 9 weeks
12039355|NCT00290394|Drug|rosiglitazone(drug), blood pressure lowering effect|
12039356|NCT00290381|Drug|Study drug administration|
12039357|NCT00290381|Procedure|Skin prick test|
12039358|NCT00290381|Procedure|12-lead ECG|
12039359|NCT00290381|Procedure|Laboratory safety samples|
12039360|NCT00290381|Procedure|Alcohol breath test|
12039361|NCT00290381|Procedure|Smokerlyzer test|
12039362|NCT00290381|Procedure|Urine drug test|
12039363|NCT00290381|Procedure|Blood test for drug concentrations|
12039364|NCT00290381|Procedure|Nasal allergen challenge|
12039365|NCT00290381|Procedure|Nasal filter paper placement|
12039366|NCT00290381|Procedure|Total nasal symptoms scores|
12039367|NCT00290368|Procedure|Skin Prick Test|
12039368|NCT00290368|Procedure|Nasal allergen challenge|
12039369|NCT00290368|Procedure|Nasal filter paper placement|
12039370|NCT00290368|Procedure|Nasal lavage|
12039371|NCT00290368|Procedure|Nasal scrape|
12039372|NCT00290368|Procedure|Nasal symptoms score|
12039373|NCT00290355|Biological|GSK 249553 vaccine|Intramuscular injection, 13 doses
12039374|NCT00290355|Biological|Placebo|Intramuscular administration, 13 doses
12039375|NCT00290342|Biological|DTPa-IPV|3 intramuscular injections
12039376|NCT00290342|Biological|DTPa|3 intramuscular injections
12039377|NCT00290342|Biological|IMOVAX Polio®|3 intramuscular injections
12039378|NCT00290329|Biological|Mencevax ACWY|1 subcutaneous injection.
12039379|NCT00290316|Procedure|Endoscopy ultrasound|
12039380|NCT00290303|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
12039381|NCT00290290|Drug|chlorhexidine-alcohol|Preoperative skin preparation with scrub and paint technique
12039382|NCT00290290|Drug|Povidone-Iodine|preoperative skin preparation with scrub and paint technique
12039383|NCT00290277|Biological|HPV-16/18 L1/AS04|
12039384|NCT00290264|Drug|Budesonide/formoterol|
12039385|NCT00290251|Drug|ulipristal acetate|ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic
12039386|NCT00290251|Drug|ulipristal acetate|10 mg given daily for three menstrual cycles or 90 - 102 days
12039387|NCT00290251|Drug|placebo|placebo given once daily for 3 menstrual cycles or 90 - 102 days
12039388|NCT00290238|Device|Vertis Percutaneous Neuromodulation Therapy (PNT)|"Ten PNT sessions in eleven weeks
~On average, one PNT session per week
~Ten lumbar Safeguide electrodes (three centimeters in length) deployed per lumbar montage
~Forty-five minutes of electrical stimulation for each session
~Electrical stimulation parameters:
~Continuous 50 Hz current
~Charge-balanced, biphasic (each phase is 200 microsec), rectangular waveform
~Intensity to subject's tolerance for ten minutes then increased to a mildly uncomfortable level"
12039389|NCT00290238|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|"Ten TENS sessions in eleven weeks
~On average, one TENS session per week
~Four 2-inch (5.1 centimeters) diameter pads applied per TENS lumbar montage
~Forty-five minutes of electrical stimulation for each session
~Electrical stimulation parameters:
~Current at 2 Hz-low frequency
~Pulse trains delivered as asymmetric, biphasic, square waveform current, with pulse width lasting 20 microsec
~Intensity titrated according to subject's sensory threshold
~To maintain blinding, the treating physician or clinician will check on the subject after 10 minutes and dial the channels down just prior to the point of turning off the device."
12039390|NCT00290225|Behavioral|Breath Water Sound Course and Traumatic Incident Reduction|
12039391|NCT00290212|Drug|Natto capsules (food suppl.) cont. 360 microg. vit K2/day|
12039392|NCT00290212|Drug|Placebo capsules|
12039393|NCT00290199|Device|Transcervical Foley catheter|Foley catheter placed through cervix for cervical ripening
12039394|NCT00290186|Device|Hyperbaric Oxygen Treatment|100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
12039395|NCT00290186|Device|Hyperbaric Air Treatment|14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
12039396|NCT00290173|Drug|efficacy of oral ritodrine in maintaining uterine quiescence|
12039397|NCT00290160|Behavioral|Protein supplementation|
12039398|NCT00290147|Biological|D1ME100 (dengue-1 premembrane/envelope DNA vaccine)|IM injection delivered by Biojector
12039399|NCT00290134|Drug|Fispemifene once daily for 4 weeks|
12039400|NCT00290121|Drug|Olanzapine|
12039401|NCT00290108|Drug|Propofol|
12039402|NCT00290082|Drug|loxapine, midazolam|agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
12039403|NCT00290082|Biological|blood sample|was evaluated in patients sedated, alcohol level, blood sugar
12039404|NCT00290082|Other|patient monitoring|Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
12039405|NCT00290082|Drug|Loxapine|Loxapine 1 mL / 10 kg
12039406|NCT00290082|Drug|Midazolam|Midazolam 1 mL / 10 Kg
12039407|NCT00290069|Drug|Tacrolimus|
12039408|NCT00290069|Drug|Rapamycin|
12039409|NCT00290056|Drug|Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).|3.6 gram oral supplementation for 6 months.
12039410|NCT00290043|Drug|Insulin glulisine|
12039411|NCT00290030|Drug|Alfuzosin|
12039412|NCT00290017|Drug|talabostat|
12039413|NCT00290017|Drug|pemetrexed|
12039414|NCT00290004|Drug|motexafin gadolinium|
12039415|NCT00289991|Drug|Itraconazole|Prophylaxis
12039416|NCT00289991|Drug|Vfend - voriconazole|Prophylaxis
12039417|NCT00289978|Drug|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
12039418|NCT00289978|Drug|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
12039419|NCT00289978|Drug|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
12039467|NCT00289640|Drug|Ipilimumab|IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
12039420|NCT00289965|Behavioral|Counselor-administered Brief Motivational Intervention (BMI)|Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
12039421|NCT00289965|Behavioral|Alcohol 101 Plus (interactive CD-ROM)|Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
12039422|NCT00289965|Behavioral|AlcoholEdu (Internet-based tutorial)|Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
12039423|NCT00289952|Drug|Valproic Acid|Oral valproic acid twice daily for 16 or 32 weeks. Dosage varies based on plasma levels.
12039424|NCT00289952|Drug|HAART|As per standard of care.
12039425|NCT00289939|Behavioral|Motivational interviewing to reduce risk for HIV and DV|
12039426|NCT00289926|Drug|dehydroepiandrosterone|dehydroepiandrosterone capsules 50.0 mg /capsule DHEA 248.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF in a 60 mg Capsule
12039427|NCT00289926|Drug|placebo|Placebo capsules of 298.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF in a 60 mg Capsule manufactured to mimic the active DHEA capsule
12039428|NCT00289913|Biological|Comparator: VAQTA™|"VAQTA™ (Hepatitis A Vaccine, Inactivated).
~Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age."
12039429|NCT00289913|Biological|Comparator: Infanrix™|"Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis
~Vaccine Adsorbed, GlaxoSmithKline).
~One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit."
12039430|NCT00289913|Biological|Comparator: PedvaxHIB™|"PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).
~One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit."
12039431|NCT00289900|Drug|MK-0524A|
12039432|NCT00289900|Drug|Atorvastatin|
12039433|NCT00289900|Drug|Simvastatin|
12039434|NCT00289887|Drug|Comparator: losartan +/- HCTZ|Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.
12039435|NCT00289887|Drug|Comparator: Placebo|Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.
12039436|NCT00289874|Drug|montelukast sodium|montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
12039437|NCT00289874|Drug|Comparator: Placebo|Placebo. Up to 3 weeks of treatment
12039438|NCT00289861|Drug|Risperidone|
12039439|NCT00289861|Drug|placebo|
12039440|NCT00289848|Drug|sitagliptin phosphate|Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
12039441|NCT00289848|Drug|Comparator: placebo|placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
12039442|NCT00289835|Device|Paclitaxel eluting stent|Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment
12039443|NCT00289822|Drug|intracoronary infusion of progenitor cells|
12039444|NCT00289809|Drug|combination of TLC D-99 and Ifosfamide|"TLC D-99: 40 mg/m2 Day 1 every 3 weeks;
~Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks"
12039445|NCT00289796|Biological|DTPa-HBV-IPV/Hib|GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine
12039446|NCT00289783|Biological|GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine|3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
12039447|NCT00289783|Biological|ActHIB|3-dose intramuscular injection at 2, 4 and 6 months of age.
12039448|NCT00289783|Biological|PedvaxHIB|1 booster dose by intramuscular injection at 12 to 15 months of age.
12039449|NCT00289783|Biological|Pediarix|3-dose intramuscular injection at 2, 4 and 6 months of age.
12039450|NCT00289783|Biological|Prevnar|3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
12039451|NCT00289783|Biological|M-M-R II|1 booster dose by subcutaneous injection at 12 to 15 months of age.
12039452|NCT00289783|Biological|Varivax|1 booster dose by subcutaneous injection at 12 to 15 months of age
12039453|NCT00289770|Biological|Twinrix™|Intramuscular injection, 3 doses
12039454|NCT00289757|Biological|Havrix™|2 doses at 6 months interval
12039455|NCT00289744|Biological|TWINRIX™ ADULT|2 doses IM injection in primary study
12039456|NCT00289744|Biological|Engerix TM|If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
12039457|NCT00289731|Biological|TWINRIX™|Intramuscular injection, 3 doses
12039458|NCT00289731|Biological|Engerix™-B|Intramuscular injection, 3 doses
12039459|NCT00289731|Biological|HAVRIX™|Intramuscular injection, 2 doses
12039460|NCT00289731|Biological|HB VAX PRO™|Intramuscular injection, 3 doses
12039461|NCT00289731|Biological|Vaqta™|Intramuscular injection, 2 doses
12039462|NCT00289718|Biological|Twinrix™ adult|Intramuscular administration
12039463|NCT00289705|Procedure|Surgery|Laparoscopic Roux-en-Y gastric bypass
12039464|NCT00289679|Device|Hip prosthesis revision|
12039465|NCT00289653|Drug|Nicoderm|
12039466|NCT00289640|Drug|ipilimumab (MDX-010, BMS-734016)|IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
12039698|NCT00287833|Other|placebo|Given orally
12039468|NCT00289640|Drug|Ipilimumab|IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
12039469|NCT00289627|Drug|ipilimumab (MDX-010, BMS-734016)|IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
12039470|NCT00289614|Drug|Iopamidol 370 mgI/dL|
12039471|NCT00289601|Drug|eptifibatide|
12039472|NCT00289588|Drug|Mupirocin (drug)|
12039473|NCT00289575|Device|MBCP|
12039474|NCT00289562|Drug|forodesine hydrochloride (BCX-1777)|
12039475|NCT00289549|Drug|forodesine hydrochloride (BCX-1777)|experimental, forodesine oral dose 200 mg administered daily.
12039476|NCT00289536|Biological|Antihemophilic factor, recombinant, manufactured protein-free|15 IU/kg rAHF-PFM
12039477|NCT00289536|Biological|Antihemophilic factor, recombinant, manufactured protein-free|30 IU/kg rAHF-PFM
12039478|NCT00289536|Biological|Antihemophilic factor, recombinant, manufactured protein-free|50 IU/kg rAHF-PFM
12039479|NCT00289510|Biological|Inactivated influenza vaccine (whole virion, Vero cell-derived)|
12039480|NCT00289510|Biological|Inactivated influenza vaccine (egg derived) [licensed control vaccine]|
12039481|NCT00289497|Device|TempTouch®|
12039482|NCT00289484|Drug|Omega-3 Polyunsaturated Fatty Acids|
12039483|NCT00289471|Other|No intervention delivered.|No intervention delivered.
12039484|NCT00289458|Behavioral|exercise|A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
12039485|NCT00289458|Behavioral|2|Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.
12039486|NCT00289458|Behavioral|Control|no exercise
12039487|NCT00289445|Drug|Mitomycin C|
12039488|NCT00289445|Drug|5-FU|
12039489|NCT00289445|Drug|Folinic acid|
12039490|NCT00289432|Behavioral|Psychoeducative|The experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment
12039491|NCT00289432|Other|Support group|Standard Hospital follow-up support group
12039492|NCT00289419|Drug|Epidural Ropivacaine, morphine|Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml
12039493|NCT00289419|Drug|Ropivacaine, Ketorolac and Adrenaline|Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml
12039494|NCT00289406|Drug|S-amlodipine gentisate|
12039495|NCT00289406|Drug|Amlodipine besylate|
12039496|NCT00289393|Behavioral|Perceived outcome by both patient and physician|
12039497|NCT00289367|Drug|Triiodothyronine|0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
12039498|NCT00289367|Drug|triiodothyronine|IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
12039499|NCT00289354|Drug|Chromium Picolinate (600 mcg Cr) + biotin (2 mg)|
12039500|NCT00289341|Biological|vaccine vehicle only|Subcutaneous injection of vaccine vehicle only (5% DMSO in normal saline), followed by cross-over to Arm 1 design.
12039501|NCT00289341|Biological|DC/LNCaP|Subcutaneous injection of DC/LNCaP, DC/LNCaP-M1, DC/KLH
12039502|NCT00289315|Behavioral|Primary (Environmental) Weight Gain Prevention|School-based program that modifies the school environment to promote healthy eating and physical activity
12039503|NCT00289315|Behavioral|Secondary (Behavioral) Weight Gain Prevention|School-based environmental program to promote healthy eating and physical activity in the overweight students.
12039504|NCT00289315|Behavioral|Control|Control program that does not include an active intervention for promoting healthy eating and physical activity.
12039505|NCT00289302|Device|Cardiac resynchronization therapy device|
12039506|NCT00289289|Device|Intervention Pacing Features|Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
12039507|NCT00289276|Device|Fluid Status Monitoring (OptiVol™)|Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
12039508|NCT00289263|Drug|Paclitaxel|
12039509|NCT00289250|Drug|Sulfadoxine-pyrimethamine|
12039510|NCT00289250|Drug|Sulfadoxine-pyrimethamine plus artesunate|
12039511|NCT00289237|Behavioral|Lifestyle intervention|
12039512|NCT00289224|Biological|bivalent killed whole cell oral cholera vaccine|"Given as 1.5 mL dose, given orally in 2 doses 14 days apart, each dose contains:
~V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS"
12039513|NCT00289224|Biological|Placebo|Heat Killed E. coli K12 in an optical turbidity identical to killed oral cholera vaccine, in 1.5 mL oral dose given twice, at least 14 days apart.
12039514|NCT00289211|Biological|C1 esterase inhibitor [human] (C1INH-nf)|
12039515|NCT00289211|Drug|Placebo (saline)|
12039516|NCT00289198|Drug|FF|fluticasone furoate 110 μg nasal spray
12039517|NCT00289198|Drug|Placebo|placebo nasal spray
12039518|NCT00289185|Biological|RTS,S/AS02D|3-dose intramuscular injection in the thigh
12039519|NCT00289185|Biological|Engerix-B®|3-dose intramuscular injection in the thigh.
12039520|NCT00289185|Biological|TETRActHib™|3-dose intramuscular injection in the thigh.
12039521|NCT00289172|Biological|Live attenuated human rotavirus vaccine|
12039522|NCT00289133|Device|total knee arthroplasty|Gamma Vacuum Foil polyethylene tibial insert
12039523|NCT00289133|Device|total knee arthroplasty|cross-linked polyethylene tibial insert
12039524|NCT00289120|Drug|Cola beverage|Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm.
12039525|NCT00289120|Drug|Deionized water|Subjects will be given 500cc of deionized water to be ingested twice daily with breakfast and dinner for three weeks while on a metabolic diet. There will be a three weeks interval before crossover to the other treatment arm
12039526|NCT00289107|Device|Total Knee Arthroplasty|Rotating Platform (RP) Cruciate Substituting Knee System
12039527|NCT00289107|Device|Total knee replacement|Fixed Cruciate Substituting Knee System
12039528|NCT00289094|Device|Total Knee Replacement|Rotating Platform (RP) Cruciate Retaining Knee System
12039529|NCT00289094|Device|Total knee replacement|Fixed Cruciate Retaining Knee System
12039530|NCT00289081|Device|Total Knee Replacement|Rotating Platform (RP) Cruciate Retaining Knee implant
12039531|NCT00289081|Device|Total knee replacement|Rotating Platform (RP) Cruciate Substituting Knee implant.
12039532|NCT00289068|Procedure|Phacoemulsification Sleeve surgery|Group 2.2 mm surgery setting
12039533|NCT00289068|Procedure|Phacoemulsification Sleeves surgery|Group 2.8 mm surgery setting
12039534|NCT00289068|Procedure|Phacoemulsification Sleeves|Group 3.0 mm surgery setting
12039535|NCT00289055|Device|stent|Cordis SMART™ Nitinol Stent
12039536|NCT00289055|Device|angioplasty|balloon angioplasty
12039537|NCT00289042|Drug|Enoxaparin|
12039538|NCT00289029|Drug|Iopamidol 370 mgI/mL|
12039539|NCT00289016|Drug|Talimogene Laherparepvec|Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
12039540|NCT00289003|Drug|Soluble beta-1,3/1,6-glucan|
12039541|NCT00288977|Procedure|Islet Infusion|
12039542|NCT00288964|Device|Hattler Respiratory Assist Catheter|
12039543|NCT00288951|Drug|Travoprost 0.004% with and without BAK|
12039544|NCT00288925|Drug|Z-360|
12039545|NCT00288912|Behavioral|Health Education|12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.
12039546|NCT00288912|Behavioral|Osteoarthritis Self-Management|12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
12039547|NCT00288899|Other|"Enhanced surgical iMedConsent process (with repeat back)"|"Consent process engages patient in discussion about why they are having procedure, risks, benefits, alternatives. Then provider asks patient to repeat backwhat they understand."
12039548|NCT00288899|Other|standard surgical iMedConsent process|Patients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented.
12039549|NCT00288886|Behavioral|Contracting, Prompting and Reinforcement arm|Contracting, prompting and reinforcement of continuing care and abstinence.
12039550|NCT00288886|Behavioral|Control arm|Routine residential treatment and orientation to continuing care.
12039551|NCT00288873|Drug|Ergocalciferol|
12039552|NCT00288873|Drug|Cholecalciferol|
12039553|NCT00288860|Behavioral|Telephone monitoring|Three months of biweekly telephone monitoring and support
12039554|NCT00288860|Other|Treatment-As-Usual|Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
12039555|NCT00288834|Behavioral|dysphagia rehabilitation|
12039556|NCT00288808|Device|Hemosense (PT/InR point of care device)|
12039557|NCT00288795|Other|Massage Therapy|Therapeutic Touch
12039558|NCT00288795|Other|Polarity Therapy|Use of energy fields to alleviate distress and achieve balance in the body
12039559|NCT00288782|Drug|Mirtazapine|
12039560|NCT00288769|Drug|daily sublingual tablets Vitamin B12 1000 mcg versus placebo|
12039561|NCT00288756|Procedure|lv injection of contrast|
12039562|NCT00288743|Drug|to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.|
12039563|NCT00288730|Drug|nesiritide|
12039564|NCT00288717|Drug|Candesartan|
12039565|NCT00288717|Drug|Telmisartan|
12039566|NCT00288704|Drug|rilonacept 160 mg|Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. On Day 1, subjects received two injections of rilonacept (for a total of 320 mg).
12039567|NCT00288704|Drug|Placebo|Subcutaneous injection of Placebo occurred during first 6 weeks of the study or during randomized withdrawal (weeks 15-24). On Day 1, subjects received two placebo injections.
12039568|NCT00288704|Drug|rilonacept 160 mg|Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. No loading dose was given for subjects who entered directly into the open-label.
12039569|NCT00288691|Drug|Asoprisnil (BAY86-5294)|5mg/day
12039570|NCT00288691|Drug|Asoprisnil (BAY86-5294)|10mg/day
12039571|NCT00288691|Drug|Asoprisnil (BAY86-5294)|25mg/day
12039572|NCT00288691|Drug|Placebo|Placebo
12039573|NCT00288678|Procedure|Health Education|
12039574|NCT00288665|Device|Export catheter (Medtronic)|
12039575|NCT00288652|Drug|[S,S]-Reboxetine|
12039576|NCT00288639|Drug|Pregabalin|"Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID).
~Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID)."
12039577|NCT00288626|Drug|Granulocyte-colony stimulating factor (G-CSF) and prednisone|Growth factor regimen; occurs at study entry
12039578|NCT00288626|Drug|Carmustine, etoposide, cytarabine, and melphalan (BEAM)|High-dose chemotherapy; occurs seven or more days following collection of autologous graft
12039579|NCT00288626|Procedure|Autologous hematopoietic stem cell transplant|Occurs after growth factor regimen and collection of autologous graft
12039580|NCT00288600|Drug|Intravenous Immunoglobulin|Intravenous Immunoglobulin
12039581|NCT00288600|Drug|Normal saline solution|Normal saline solution 10 ml/Kg
12039582|NCT00288587|Drug|IV loop diuretic|Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
12039583|NCT00288587|Device|NxStage System One|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
12039584|NCT00288574|Drug|Fluoxetine|
12039585|NCT00288574|Drug|Placebo|
12039586|NCT00288561|Drug|ranibizumab|
12039587|NCT00288548|Drug|Metoprolol|
12039770|NCT00287313|Drug|Vitamin K|
12039588|NCT00288535|Procedure|PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique|
12039589|NCT00288522|Drug|Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days|
12039590|NCT00288509|Biological|Botulinum toxin type A|In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety & efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.
12039591|NCT00288496|Drug|polyethylene glycol bowel lavage solution|
12039592|NCT00288483|Drug|Policosanol|
12039593|NCT00288470|Device|Hylaform, Hylaform Plus (hylan B gel)|
12039594|NCT00288457|Device|Ureteral Stent|Ureteral stents are not investigatory but rather part of standard of care. In this study, we were interested in having patients fill out pre and post-operative questionnaires so that we could compare their symptoms with the length of their ureter and the stent placed.
12039595|NCT00288444|Drug|Lonafarnib|
12039596|NCT00288444|Drug|Docetaxel|
12039597|NCT00288431|Drug|ridaforolimus|Different schedules and routes of administration of AP23573 will be examined. For each schedule, AP23573 + Doxorubicin will be co-administered on Day 1 of a 3-week cycle. AP23573 will be given orally and will range in dose from 10-30 mg per dose.
12039598|NCT00288431|Drug|Doxorubicin|administered at 60 mg/m2 intravenously every 3 weeks
12039599|NCT00288418|Device|Central Venous Catheter|7-French x 20-cm, triple lumen, short-term CVC vs. 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
12039600|NCT00288405|Device|Cordis Self Expanding Stent|
12039601|NCT00288392|Drug|Soluble beta-1,3/1,6-glucan|
12039602|NCT00288379|Drug|formoterol|
12039603|NCT00288379|Drug|budesonide/formoterol|
12039604|NCT00288366|Drug|ziprasidone vs. aripiprazole|ziprasidone vs. aripiprazole dosed according to package insert
12039605|NCT00288366|Drug|aripiprazole vs. ziprasidone|aripiprazole vs. ziprasidone dosed according to package insert
12039606|NCT00288353|Drug|aripiprazole (Abilify)|active drug given daily as per package insert according to standard clinical care for twelve month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.
12039607|NCT00288353|Drug|ziprasidone (Geodon)|active medication will be given daily as per package insert according to standard clinical care for the twelve month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
12039608|NCT00288340|Device|functional magnetic resonance imaging|
12039609|NCT00288327|Behavioral|Lifestyle behavior change program|Intervention included a six-month intensive intervention of 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls.
12039610|NCT00288327|Behavioral|Pamphlets|Nutritional and physical activity pamphlets from American Heart Association
12039611|NCT00288314|Procedure|Magnetic Resonance Imaging, Functional|Structural and functional MRI
12039612|NCT00288301|Behavioral|Weight loss intervention|weight loss intervention
12039613|NCT00288288|Procedure|Epicardial left ventricular lead placement|Epicardial left ventricular lead placement
12039614|NCT00288288|Procedure|Transvenous left ventricular lead implant|Transvenous left ventricular lead implant
12039615|NCT00288262|Drug|melatonin 0.5 mg|
12039616|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
12039617|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
12039618|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
12039619|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
12039620|NCT00288236|Drug|Rimonabant (SR141716)|
12039621|NCT00288236|Drug|Placebo|
12039622|NCT00288223|Drug|Telithromycin|one daily intake of 800 mg (i.e. 2 x 400 mg tablets) per os in a single intake with a meal for 5 days.
12039623|NCT00288210|Procedure|Primary angioplasty in acute myocardial infarction|
12039624|NCT00288197|Drug|voriconazole|
12039625|NCT00288184|Drug|Allopurinol|Allopurinol adminsitered one 200mg capsule by mouth twice daily. Placebo capsule once daily during crossover
12039626|NCT00288184|Drug|Placebo|
12039627|NCT00288171|Drug|Placebo|placebo capsule twice daily for one month
12039628|NCT00288171|Drug|Allopurinol|Allopurinol 200mg twice daily for one month
12039629|NCT00288158|Drug|Allopurinol|
12039630|NCT00288158|Drug|Probenecid|
12039631|NCT00288158|Drug|Placebo|
12039632|NCT00288145|Behavioral|WOW, Working On Wellness weight management|Treatment site, worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management.
12039633|NCT00288132|Behavioral|Intervention|A 12-month diabetes self-management intervention delivered via telemedicine, with opportunity to receive telemedicine-based screening eye exam, was conducted.
12039634|NCT00288132|Behavioral|Usual Care|Upon randomization, received one 15-minute diabetes self-management individual session, using American Diabetes Association materials. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.
12039693|NCT00287885|Drug|docetaxel|Three patients will be enrolled and dosed at each level; from dose level 1 of 2.9 mg/m^2/day up to dose level 6 of 6.4 mg/m^2/day
12039694|NCT00287872|Drug|bortezomib|
12039695|NCT00287872|Drug|thalidomide|
12039696|NCT00287859|Drug|topotecan hydrochloride|intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.
12039635|NCT00288119|Device|Balloon Capsule Device|The Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize & protect the site-specific sample collection.
12039636|NCT00288119|Procedure|Endoscopy|An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
12039637|NCT00288106|Other|Follow-up|No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
12039638|NCT00288093|Radiation|3-Dimensional Conformal Radiation Therapy|
12039639|NCT00288093|Drug|Triapine|
12039640|NCT00288080|Drug|Dexamethasone|Premedication of dexamethasone prior to docetaxel, per institutional standards.
12039641|NCT00288080|Drug|Prednisone|10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.
12039642|NCT00288080|Drug|docetaxel|75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.
12039643|NCT00288080|Drug|Oral antiandrogen|Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.
12039644|NCT00288080|Radiation|Radiation therapy|46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.
12039645|NCT00288080|Drug|LHRH agonist|LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.
12039646|NCT00288067|Drug|fenretinide|Given PO
12039647|NCT00288067|Drug|rituximab|Given IV
12039648|NCT00288054|Biological|cetuximab|"Cohorts 1 and 2: 400 mg/m2 (initial dose) 2 hour IV infusion on Day 1, Cycle 1 only.
~250 mg/m2, 1 hour IV infusion on Days 8 , 15 and 22 during Cycle 1. 250 mg/m2 (subsequent doses), 1 hour IV infusion on Days 1, 8 , 15 and 22 during subsequent cycles."
12039649|NCT00288054|Drug|docetaxel|"Cohort 2 ONLY: 20 mg/m2 IV over 15 - 30 minutes on Days 8, 15 and 22 of Cycle 1. Concurrent with RT and cetuximab starting at Week 2.
~20 mg/m2 IV over 15 - 30 minutes on Days 1, 8, 15 and 22 of Cycle 2."
12039650|NCT00288054|Radiation|radiation therapy|"Radiation therapy should begin on Day 8 of Cycle 1 and continue through the end of Cycle 2. Refer to Section 12.1 for Radiation Therapy Review.
~RT prescription should be PTV (GTV + 2-cm margins on CT scan) to 6,480 cGy in 36 fractions given 5 days a week, 180 cGy per day. The dose is prescribed to the isocenter. The entire treatment should be planned prior to starting treatment to ensure that the plan meets protocol specifications."
12039651|NCT00288041|Drug|carboplatin|Given IV
12039652|NCT00288041|Drug|paclitaxel|Given IV
12039653|NCT00288041|Drug|bortezomib|Given IV
12039654|NCT00288028|Drug|bortezomib|Dose of Bortezomib* Level 1: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 21 days; Level 2: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 28 days; Level 3: 1.0 mg/m2 on Day 1, 8, 15 - Every 28 days; Level 4: 1.0 mg/m2 on Day 1, 8, 15 - Every 35 days
12039655|NCT00288015|Biological|Bevacizumab|Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).
12039656|NCT00288002|Biological|trastuzumab|
12039657|NCT00288002|Drug|capecitabine|
12039658|NCT00288002|Drug|cyclophosphamide|
12039659|NCT00288002|Drug|docetaxel|
12039660|NCT00288002|Drug|epirubicin hydrochloride|
12039661|NCT00288002|Procedure|adjuvant therapy|
12039662|NCT00288002|Procedure|conventional surgery|
12039663|NCT00288002|Procedure|neoadjuvant therapy|
12039664|NCT00287989|Drug|Carboplatin|
12039665|NCT00287989|Drug|erlotinib hydrochloride|150mg
12039666|NCT00287989|Drug|Paclitaxel|200mg/m2
12039667|NCT00287989|Drug|erlotinib hydrochloride|1500mg
12039668|NCT00287976|Drug|irinotecan hydrochloride|
12039669|NCT00287963|Drug|topotecan hydrochloride|
12039670|NCT00287963|Drug|vinorelbine tartrate|
12039671|NCT00287950|Drug|carboplatin|
12039672|NCT00287950|Drug|cisplatin|
12039673|NCT00287950|Drug|cyclophosphamide|
12039674|NCT00287950|Drug|etoposide|
12039675|NCT00287950|Drug|vincristine sulfate|
12039676|NCT00287950|Procedure|adjuvant therapy|
12039677|NCT00287950|Procedure|conventional surgery|
12039678|NCT00287950|Procedure|neoadjuvant therapy|
12039679|NCT00287950|Radiation|radiation therapy|
12039680|NCT00287937|Drug|vorinostat|Given orally
12039681|NCT00287937|Drug|paclitaxel|Given IV
12039682|NCT00287937|Drug|carboplatin|Given IV
12039683|NCT00287937|Other|laboratory biomarker analysis|Correlative studies
12039684|NCT00287937|Other|pharmacological study|Correlative studies
12039685|NCT00287924|Drug|methotrexate|
12039686|NCT00287924|Procedure|adjuvant therapy|
12039687|NCT00287911|Drug|cisplatin|intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36
12039688|NCT00287911|Drug|topotecan hydrochloride|intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined
12039689|NCT00287911|Radiation|brachytherapy|Some patients may also undergo brachytherapy
12039690|NCT00287911|Radiation|radiation therapy|once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36
12039691|NCT00287898|Behavioral|Telephone Genetic Counseling|Participants will receive all genetic counseling via telephone
12039692|NCT00287898|Behavioral|Usual Care|subjects will receive standard in-person genetic counseling
12039699|NCT00287833|Drug|Bowman-Birk inhibitor concentrate|Given orally
12039700|NCT00287820|Drug|Olanzapine|olanzapine 5-40 mg/day
12039701|NCT00287820|Drug|olanzapine|olanzapine 5-40 ,mg/day
12039702|NCT00287820|Drug|risperidone|risperidone 1-12 mg/day
12039703|NCT00287807|Behavioral|Self-monitoring of blood glucose (SMBG)|2 times a week (one in weekend and one during week) self measurement of blood glucose: fasting and three times post prandial
12039704|NCT00287794|Drug|diazepam, melatonin|Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.
12039705|NCT00287781|Drug|Lidocaine|
12039706|NCT00287768|Drug|docetaxel + S-1|Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
12039707|NCT00287768|Drug|S-1|S-1 po days 1-28 every 6 weeks
12039708|NCT00287755|Drug|S-1|S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
12039709|NCT00287742|Drug|risperidone|
12039710|NCT00287729|Drug|Pirfenidone|2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.
12039711|NCT00287729|Drug|Placebo|Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
12039712|NCT00287716|Drug|Pirfenidone|1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.
12039713|NCT00287716|Drug|Placebo|Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
12039714|NCT00287703|Device|Pulsating Electro-Magnetic Fields|5 days a week for 5 weeks 30 minutes
12039715|NCT00287703|Device|Pulsating Electro-Magnetic Fields sham|sham PEMF
12039716|NCT00287690|Drug|Genistein|Drink taken once daily
12039717|NCT00287690|Drug|Placebo|Drink taken once daily
12039718|NCT00287677|Biological|recombinant human Growth Hormone|Growth Hormone during 6 months (30UG/KG/DAY)
12039719|NCT00287677|Biological|Vaccination|Vaccination (Hepatitis A+B + tetanus toxoid) at week 16
12039720|NCT00287677|Drug|HAART|HAART all over the trial
12039721|NCT00287664|Drug|terlipressin|
12039722|NCT00287651|Procedure|Pulsatile IV Insulin|Intravenous Insulin is provided in a pulsed manner based upon weekly physician orders the amount of insulin provided is dependent on patients level of insulin resistance.
12039723|NCT00287651|Procedure|Effects of Pulsatile IV Insulin on Diabetic Retinopathy|Control Patients are not given pulsatile intravenous insulin therapy during the study.
12039724|NCT00287651|Procedure|Effects of Pulsatile IV Insulin on Diabetic Retinopathy|Intravenous Insulin is provided in a pulsed manner based upon weekly physician orders the amount of insulin provided is dependent on patients level of insulin resistance.
12039725|NCT00287638|Device|CPAP|Continuous positive pressure device with a time clock
12039726|NCT00287638|Device|placebo|no CPAP
12039727|NCT00287625|Procedure|Pulmonary rehabilitation|Pulmonary rehabilitation
12039728|NCT00287612|Procedure|Lap. Fundo. with Mobilization of the Esophageal Junction|Complete mobilization of the esophageal junction
12039729|NCT00287612|Procedure|Lap. Fundo. without Mobilization of the Esophageal Junction|phrenoesophageal membrane left intact
12039730|NCT00287586|Drug|Testosterone Gel (Androgel)|7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years
12039731|NCT00287586|Drug|Placebo|Placebo-matching testosterone gel daily for 3 years
12039732|NCT00287573|Device|TAXUS Express2|Paclitaxel-Eluting Coronary Stent System
12039733|NCT00287573|Procedure|Brachytherapy (beta source)|Brachytherapy (beta source)
12039734|NCT00287560|Drug|propofol (drug)|
12039735|NCT00287547|Drug|CTLA4Ig / Abatacept|
12039736|NCT00287534|Drug|Anastrozole|oral
12039737|NCT00287534|Drug|Tamoxifen|oral
12039738|NCT00287521|Drug|AL-37807 Ophthalmic Suspension, 1.0%|One drop in the study eye(s) once daily for 28 days
12039739|NCT00287521|Drug|Latanoprost, 0.005% (Xalatan)|One drop in the study eye(s) once daily for 28 days
12039740|NCT00287521|Other|AL-37807 Vehicle|One drop in the study eye(s) once daily for 28 days
12039741|NCT00287521|Drug|Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%|One drop in the study eye(s) once daily for 28 days
12039742|NCT00287508|Device|Carotid artery stenting with filter (interventional)|
12039743|NCT00287495|Drug|BAY 43-9006|BAY 43-9006 200 mg once daily with dose escalation up to 400 mg twice daily
12039744|NCT00287482|Drug|Essiac|
12039745|NCT00287469|Biological|Hepatitis E vaccine, recombinant (Sar 56 kDa)|20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
12039746|NCT00287469|Other|Placebo|PBS buffer placebo containing alum
12039747|NCT00287456|Device|Insulin Pump|
12039748|NCT00287456|Drug|Insulin|0
12039749|NCT00287456|Procedure|Oral Glucose Tolerance Test|0
12039750|NCT00287456|Procedure|Whole body Protein Turnover|0
12039751|NCT00287443|Procedure|Oral Glucose tolerance test|
12039752|NCT00287443|Procedure|Whole body protein turnover|
12039753|NCT00287443|Procedure|IV glucose tolerance test|
12039754|NCT00287443|Procedure|Indirect Calorimetry|
12039755|NCT00287443|Procedure|Dual Energy X-ray Absorptiometry (DEXA)|
12039756|NCT00287443|Procedure|Growth Hormone Stimulation Test|
12039757|NCT00287430|Drug|Growth Hormone|
12039758|NCT00287430|Procedure|Whole body Protein Turnover Study|
12039759|NCT00287430|Procedure|Dual Energy X-ray Absorptiometry (DEXA)|
12039760|NCT00287417|Device|echography|
12039761|NCT00287417|Other|blood sample|
12039762|NCT00287391|Drug|Rabeprazole|
12039763|NCT00287378|Drug|omalizumab|omalizumab as per weight and IgE
12039764|NCT00287365|Drug|ozone|2 hour exposure to 0.4 ppm ozone
12039765|NCT00287352|Drug|Olanzapine, Amantadine|Olanzapine continuing as clinically indicated, Amantadine 100 mg tid
12039766|NCT00287352|Drug|Olanzapine and placebo|Olanzapine continuing as clinically indicated
12039767|NCT00287339|Drug|Esomeprazole|40mg capsule BID for 12 weeks
12039768|NCT00287339|Drug|Placebo|placebo capsule BID for 12 weeks
12039769|NCT00287326|Drug|Bupivacaine, Clonidine, Morphine|
12039771|NCT00287300|Drug|Sulfadoxine-Pyrimethamine|
12039772|NCT00287300|Drug|Azithromycin|
12039773|NCT00287300|Drug|Artesunate|
12039774|NCT00287287|Drug|Lenalidomide|Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
12039775|NCT00287274|Device|computerized physician order entry|
12039776|NCT00287261|Drug|zoledronic acid|4 mg IV every 3 weeks for 36 weeks
12039777|NCT00287248|Drug|[123I] IMPY & SPECT Imaging|Subjects will be injected with 7mCi of [123I]IMPY, followed by SPECT imaging
12039778|NCT00287235|Device|MARS|
12039779|NCT00287235|Drug|Standard Medical Therapy|
12039780|NCT00287222|Drug|Bevacizumab|15 mg/KG I.V. every 21 days
12039781|NCT00287222|Drug|Erlotinib|150 mg orally every day
12039782|NCT00287209|Drug|Amiodarone|
12039783|NCT00287196|Radiation|Radiotherapy|48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
12039784|NCT00287183|Drug|PF-04494700 (TTP488)|60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
12039785|NCT00287183|Other|Placebo|Placebo
12039786|NCT00287170|Drug|Delayed Release 6MP or Calcitriol vs. Purinethol|
12039787|NCT00287157|Drug|Sublingual Tizanidine HCl|
12039788|NCT00287131|Procedure|Procedure - Adoptive cell transfer|Procedure - Adoptive cell transfer
12039789|NCT00287118|Drug|Efalizumab|Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
12039790|NCT00287105|Drug|Standard chemotherapy + Imatinib|Patients receive Imatinib together with the standard chemotherapy regimen of phase IB and after each of three consecutive blocks of the standard chemotherapy in the consolidation phase
12039791|NCT00287092|Biological|DT5aP-IPV-Hib 5-component Pertussis vaccine|0.5 mL, IM
12039792|NCT00287092|Biological|Infanrix® -IPV+Hib|0.5 mL, IM
12039793|NCT00287079|Drug|Rebif®|44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
12039794|NCT00287079|Other|No Treatment|No treatment for 96 weeks
12039795|NCT00287066|Drug|Inhaled Human Insulin|
12039796|NCT00287066|Drug|Regular Human Insulin|
12039797|NCT00287053|Drug|divalproex sodium|Divalproex sodium vs. placebo
12039798|NCT00287040|Behavioral|Tailored, interactive intervention for mammography screening|Follow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings
12039799|NCT00287027|Drug|Risperdal Long Acting Injectable Antipsychotic Medication|
12039800|NCT00287001|Device|Cold air cooling|
12039801|NCT00286988|Drug|Topiramate|
12039802|NCT00286975|Behavioral|Leadership development program educational intervention|
12039803|NCT00286962|Device|MIP 2007C implantable insulin pump|Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
12039804|NCT00286962|Device|continuous subcutaneous insulin infusion (CSII) or MDI|
12039805|NCT00286949|Drug|Atomoxetine|Open Label uncontrolled active Drug intervention
12039806|NCT00286936|Drug|Zolpidem|
12039807|NCT00286923|Drug|Topiramate|
12039808|NCT00286897|Drug|E2007|
12039809|NCT00286884|Procedure|Monitoring of heart rate variability|
12039810|NCT00286871|Drug|Neoral|
12039811|NCT00286871|Drug|Tacrolimus|
12039812|NCT00286858|Device|Insignia Ultra and Insignia AVT|Regular AV-Delay increase to allow for intrinsic AV conduction, if present.
12039813|NCT00286845|Drug|Standard Chemotherapy|physician determined
12039814|NCT00286832|Procedure|PET scan|One extra PET scan after 1 cycle of treatment.
12039815|NCT00286819|Drug|the FEC75 and 95 regimen|"Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
~Arm B: the FEC90 regimen will be given at the following doses:
~Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.
~All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
~Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.
~Six cycles of adjuvant chemotherapy will be administered in both arms (A + B"
12039816|NCT00286806|Drug|AT-101|
12039817|NCT00286793|Drug|AT-101|Oral
12039818|NCT00286780|Drug|AT-101|80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks
12039819|NCT00286754|Behavioral|SMI|Stage-matched intervention
12039820|NCT00286754|Behavioral|HEI|Health Education Intervention
12039821|NCT00286754|Behavioral|UC|Usual Care
12039822|NCT00286754|Behavioral|SMI|Stage-matched intervention
12039823|NCT00286754|Behavioral|HEI|Health Education Intervention
12039824|NCT00286754|Behavioral|UC|Usual Care
12039825|NCT00286741|Other|Diabetes Group Management Visits|Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
12039826|NCT00286728|Behavioral|Intensive referral to dual-focused self-help|4 group sessions to introduce patients to dual focused groups
12039827|NCT00286702|Device|hand splint|
12039828|NCT00286689|Drug|Growth Hormone|
12039829|NCT00286689|Procedure|Whole body Protein turnover|
12039830|NCT00286689|Procedure|DEXA scan|
12039831|NCT00286676|Drug|Nutropin|
12039832|NCT00286676|Procedure|Oral Glucose Tolerance Test|
12039833|NCT00286676|Procedure|Dual Energy X-ray Absorptiometry (DEXA)|
12039834|NCT00286676|Procedure|Computed Tomography (CT) Scan|
12039835|NCT00286650|Procedure|3rd molar teeth extraction|
12039836|NCT00286624|Biological|Allogeneic Islets of Langerhans|Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. First infusion to contain at least 5,000 islet equivalents/kg body weight. Subsequent infusions to contain at least 3,000 islet equivalents/kg body weight.
12039880|NCT00286273|Drug|trisodium citrate|for regional anticoagulation of the extracorporeal CVVH circuit
12039837|NCT00286624|Drug|Everolimus|Loading dose of 3 mg PO on day -2 relative to transplant, followed at least 12 hours later by dose of 1.5 mg PO BID. The daily dose will be adjusted according to the whole blood 12-hr trough to target 3-15 ng/ml for the first 3 months and 3-12 ng/ml thereafter.
12039838|NCT00286624|Drug|anti-thymocyte globulin|A total of 6 mg/kg IV over 12 hours on days -2, -1, 0, +1, and +2. The dose will be 0.5 mg/kg on day -2, 1.0 mg/kg on day -1, and 1.5 mg/kg on days 0, +1, and +2.
12039839|NCT00286624|Drug|Cyclosporine|Cyclosporine started on day +1 relative to the first islet transplant. Initial dose of 3 mg/kg/day administered in 2 divided doses; then adjusted to maintain target levels of 400 (350-500) ng/mL for the first three months following islet transplant and 300 (200-350) ng/mL thereafter.
12039840|NCT00286611|Procedure|Blood and salivary sampling of amifostine|Sampling of blood and saliva to test for amifostine levels.
12039841|NCT00286598|Behavioral|Feet First|Phase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.
12039842|NCT00286585|Drug|Inhalational anesthetic|Sevoflurane, dosage according to the physician in charge
12039843|NCT00286585|Drug|Intravenous anesthetic, propofol|Propofol, dosage according to the physician in charge
12039844|NCT00286559|Drug|SonoVue|
12039845|NCT00286559|Drug|Optison|
12039846|NCT00286533|Procedure|Clinical examination (implant stability, gingiva condition, etc.)|Clinical examination (implant stability, gingiva condition, etc.) to follow
12039847|NCT00286533|Procedure|Questionnaires|Questionnaires are used.
12039848|NCT00286520|Procedure|Transanal irrigation with Peristeen Anal Irrigation|
12039849|NCT00286507|Procedure|Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.|Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling
12039850|NCT00286494|Drug|Alogliptin and pioglitazone|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
12039851|NCT00286494|Drug|Alogliptin and pioglitazone|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
12039852|NCT00286494|Drug|Pioglitazone|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
12039853|NCT00286481|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
12039854|NCT00286481|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
12039855|NCT00286481|Drug|Simvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
12039856|NCT00286468|Drug|Alogliptin and glyburide|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
12039857|NCT00286468|Drug|Alogliptin and glyburide|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
12039858|NCT00286468|Drug|Glyburide|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
12039859|NCT00286455|Drug|Alogliptin|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
12039860|NCT00286455|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
12039861|NCT00286455|Drug|Placebo|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
12039862|NCT00286442|Drug|Alogliptin and metformin|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
12039863|NCT00286442|Drug|Alogliptin and metformin|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
12039864|NCT00286442|Drug|Metformin|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
12039865|NCT00286429|Drug|Alogliptin and insulin|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
12039866|NCT00286429|Drug|Alogliptin and insulin|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
12039867|NCT00286429|Drug|Insulin|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
12039868|NCT00286416|Drug|omalizumab (Xolair)|
12039869|NCT00286403|Drug|Fenoldopam Mesylate and/or MESNA|
12039870|NCT00286390|Procedure|Acupuncture|
12039871|NCT00286377|Drug|prosaptide|
12039872|NCT00286364|Drug|Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COH|
12039873|NCT00286351|Drug|Combined treatment with Arimidex and Zoladex before IVF|
12039874|NCT00286325|Drug|Rituximab|Infusion of 1000 mg of rituximab on day 0 and day 14
12039875|NCT00286312|Drug|Atorvastatin|
12039876|NCT00286299|Other|Aerobic high-intensity interval training (AIT)|The AIT group trains 4x4 minute interval training on a treadmill at 85-95 % HRpeak interspersed with 3 minutes of active resting periods at a work load corresponding to 70% HRpeak between each interval. All training sessions are monitored and start with a 6 minute warm-up and end with a 5 minute cool-down period at a work load corresponding to 70% HRpeak. Intervals are performed walking or running on a treadmill with a minimum of 5% inclination, 3 times per week for 8 weeks.
12039877|NCT00286299|Other|Computer game training (CG)|The CG spend the same amount of time (36 minutes), training to improve their ability in the computer game, Tetris. Tetris is a game where small shapes called Tetraminoes fall from the top of the Playfield to the bottom. Players must rotate the Tetraminoes as they fall and fit them together to complete lines. When the player fills an entire line with blocks, that line is removed from the screen. If the player cannot complete lines, the blocks will eventually rise past the top of the screen, and the game ends.
12039878|NCT00286299|Other|Maximal strength training|Training starts with a 10 minute warm-up on the treadmill. Maximal strength training is then performed in an inclined leg press machine. The subject lifts 4 maximal repetitions that are repeated 4 times after a 2 minute rest period. Subjects are instructed to lift the weight with an intention of maximal mobilization of force. Training load is increased each time the subject manage to perform 4x4 maximal repetitions. Training is carried out 3 times per week in 8 weeks.
12039879|NCT00286286|Device|Intraperitoneal Aerosolization System, IntraMyst|
12040056|NCT00284531|Drug|Daclizumab|
12039881|NCT00286273|Drug|nadroparin|for anticoagulation of the extracorporeal CVVH circuit
12039882|NCT00286260|Drug|levetiracetam|Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks
12039883|NCT00286247|Genetic|INGN 201|
12039884|NCT00286234|Drug|omega-3 acid ethyl esters|4 q qd
12039885|NCT00286234|Drug|extended release niacin|2 g qpm
12039886|NCT00286234|Drug|placebo|omacor placebo plus niaspan placebo
12039887|NCT00286234|Drug|omega-3 acid ethyl esters|4 g qd
12039888|NCT00286234|Drug|combined treatment|omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
12039889|NCT00286221|Drug|PCA fentanyl|"PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
12039890|NCT00286221|Drug|PRN fentanyl|IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
12039891|NCT00286208|Drug|Mifepristone, misoprostol|
12039892|NCT00286195|Device|Multi-Link Frontier Coronary Stent System|Bare metal stent
12039893|NCT00286182|Drug|Erythropoietin alpha|Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in any given weekly interval.
12039894|NCT00286182|Drug|Placebo|Placebo
12039895|NCT00286169|Drug|Amrubicin Hydrochloride|
12039896|NCT00286156|Drug|Rapamune|Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml Group 3- Standard Care
12039897|NCT00286143|Drug|Fentanyl|Fentanyl is added to epidural Bupivacaine to be administered to neonates having thoracotomy for lung resections.
12039898|NCT00286130|Drug|Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan|
12039899|NCT00286130|Drug|FOLFOX 6|"FOLFOX 6:
~Oxaliplatin 100 mg/m² d1 concurrent with
~Leucovorin 400 mg/m², followed by
~Bolus 5FU 400 mg/m² , followed by
~Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:"
12039900|NCT00286130|Drug|FOLFIRI|"FOLFIRI:
~Irinotecan 180 mg/m² day 1 concurrent with
~Leucovorin 400 mg/m² followed by
~Bolus 5FU 400 mg/m², followed by
~Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks"
12039901|NCT00286117|Drug|Anastrozole|oral
12039902|NCT00286117|Drug|Tamoxifen|oral
12039903|NCT00286104|Device|Antibiotics-impregnated ventricular catheter (Bactiseal®)|Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)
12039904|NCT00286104|Device|Plain ventricular catheter (Codman EDS II/III)|Plain ventricular catheter
12039905|NCT00286091|Biological|Denosumab|Administered by subcutaneous injection
12039906|NCT00286091|Biological|Placebo|Same volume subcutaneous injection
12039907|NCT00286078|Device|Precision|Implantable neurostimulator
12039908|NCT00286065|Drug|AeroLEF|
12039909|NCT00286052|Drug|Low Dose Naloxone|
12039910|NCT00286039|Procedure|Blood sampling|Blood sampling is used.
12039911|NCT00286026|Drug|Azithromycin|1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg. One dose vs 2 doses given 30 days apart.
12039912|NCT00286013|Drug|Association of gemcitabine, oxaliplatin and radiotherapy|
12039913|NCT00286000|Drug|Administration of high dose simplified folfiri|
12039914|NCT00285987|Procedure|Reconstruction of the cruciate ligament|
12039915|NCT00285974|Device|metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis|metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
12039916|NCT00285961|Device|Cork splint materials (instead of plaster splint)|
12039917|NCT00285948|Device|Primary Birmingham hip resurfacing arthroplasty using a metal-on-metal couple|
12039918|NCT00285935|Other|Standard Clinical Care with an SRRI|"Participants who enroll in this phase are treated with an FDA-approved SSRI in an open-label treatment-as-usual manner, in accordance with clinical practices and at a titration rate no more rapid than the manufacturer's recommendations. The duration of the treatment phase is 8 weeks.
~Other Name: fluoxetine (Prozac®), Sertraline (Zoloft®), paroxetine (Paxil®), citalopram (Celexa®), escitalopram (Lexapro®)"
12039919|NCT00285909|Behavioral|Alcohol: 25 gday (white wine)|
12039920|NCT00285896|Drug|Glucagon-like-peptide-1 (7-36) amide|Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours
12039921|NCT00285896|Drug|Placebo|continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours
12039922|NCT00285883|Drug|Invirase|
12039923|NCT00285883|Drug|Norvir|
12039924|NCT00285857|Drug|Lovastatin|"Lovastatin 80 mg/day as 40 mg orally twice daily.
~Lovastatin is approved by FDA as a cholesterol-lowering agent."
12039925|NCT00285844|Behavioral|weight loss|
12039926|NCT00285844|Drug|thiazolidinedione|
12039927|NCT00285818|Drug|Mifepristone|Mifepristone is a glucocorticoid receptor antagonist.
12039928|NCT00285818|Drug|Placebo Oral Capsule|Placebo is a capsule without a pharmacological active ingredient
12039929|NCT00285805|Drug|Rosiglitazone versus placebo|
12039930|NCT00285805|Drug|response (sodium excretion) to amiloride infusion|
12039931|NCT00285805|Drug|response (sodium excretion) to furosemide infusion|
12039932|NCT00285792|Behavioral|Physical Activity|
12039933|NCT00285779|Drug|Etanercept|etanercept 50 mg twice weekly for 12 weeks
12039934|NCT00285779|Drug|Placebo|
12039935|NCT00285766|Drug|Selegiline Transdermal System|
12039936|NCT00285753|Behavioral|support groups|cognitive behavioral intervention with psychoeducation
12039937|NCT00285740|Behavioral|Cognitive Behavioral Therapy (CBT) in a Group Format|
12039938|NCT00285727|Drug|Ropinirole CR|
12039939|NCT00285714|Procedure|3D stereophotogrammetric imaging|
12039940|NCT00285714|Procedure|3D CT-imaging with cone-beam CT|
12039941|NCT00285714|Procedure|Case report form|
12039942|NCT00285701|Drug|hexaminolevulinate|
12039943|NCT00285688|Procedure|gastroscopic examination|gastroscopic examination for tissue biopsy and real time PCR for gene study
12039944|NCT00285675|Drug|DN-101 (calcitriol) - Drug|
12039945|NCT00285662|Drug|Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo|Children will get 25mg/1.25mg/kg of SP as a single dose, 4 mg/kg for 3 days of Artesunate and 10 mg/kg for 3 days of Amodiaquine in their respective arms
12039946|NCT00285649|Other|HVLA-SM|HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
12039947|NCT00285649|Other|LVVA-SM|LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
12039948|NCT00285649|Other|Usual Medical Care|Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
12039949|NCT00285623|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|treatment in surgery for improvement of haemostasis where standard techniques are insufficient
12039950|NCT00285597|Drug|Ursodeoxycholic Acid|
12039951|NCT00285584|Drug|Bupropion|Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
12039952|NCT00285584|Drug|Placebo|Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
12039953|NCT00285571|Behavioral|Controlled Feeding Intervention|
12039954|NCT00285558|Behavioral|CBT with peer-enhanced activities|
12039955|NCT00285558|Behavioral|CBT with supervised aerobic exercise|
12039956|NCT00285519|Drug|Doxazosin (drug)|
12039957|NCT00285493|Drug|Antibiotics|
12039958|NCT00285467|Drug|doxercalciferol|form of vitamin D that is already in active form.
12039959|NCT00285467|Drug|Cholecalciferol|from of vitamin D that requires cells in the body to make active
12039960|NCT00285454|Procedure|Retrograde coronary venous delivery of cells.|
12039961|NCT00285428|Drug|hA20-humanized anti-CD20 antibody|once weekly iv dosing for 4 weeks
12039962|NCT00285415|Drug|Docetaxel and Carboplatin|docetaxel (75 mg/m2) + carboplatin (AUC 6) IV every 3 weeks X 6 cycles
12039963|NCT00285402|Drug|AST-726 Low dose|
12039964|NCT00285402|Drug|AST-726 High dose|
12039965|NCT00285402|Drug|AST-726 Placebo|
12039966|NCT00285389|Drug|Adriblastin|
12039967|NCT00285389|Drug|dexamethasone|
12039968|NCT00285389|Drug|Chlorambucil|
12039969|NCT00285389|Drug|rituximab|
12039970|NCT00285389|Drug|cyclophosphamide|
12039971|NCT00285389|Drug|alkeran|
12039972|NCT00285389|Procedure|Total body irradiation (8Gy/4fr)|
12039973|NCT00285389|Drug|vincristine|0,4 mg/day day 1 to day 4
12039974|NCT00285376|Drug|vilazodone|titration to 40mg tablets qd for 8 weeks
12039975|NCT00285350|Drug|mycophenolate mofetil|
12039976|NCT00285337|Procedure|Laminectomy and Laminoplasty|Posterior versus anterior approach to laminectomy and laminoplasty
12039977|NCT00285298|Drug|Pentoxifylline|
12039978|NCT00285298|Drug|Placebo|
12039979|NCT00285285|Device|Point of Care Device; i-Stat Analyzer|
12039980|NCT00285259|Biological|VCL-CB01|5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
12039981|NCT00285259|Other|Phosphate-buffered Saline (PBS)|1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
12039982|NCT00285233|Biological|Allogeneic islets of Langerhans transplant|Allogeneic islets of Langerhans transplant
12039983|NCT00285220|Procedure|Laparoscopic Truncal Vagotomy|
12039984|NCT00285207|Drug|placebo|5 days of 28 day cycle for 2 cycles
12039985|NCT00285207|Drug|A007|5 days of 28 day cycle
12039986|NCT00285194|Drug|Allogeneic Islets of Langerhans|
12039987|NCT00285194|Drug|hOKT3γ1 (Ala-Ala)|
12039988|NCT00285181|Drug|Simvastatin|
12039989|NCT00285168|Behavioral|Bone Density Decision Aide|Absolute 10-year Fracture Risk Report
12039990|NCT00285155|Drug|Bupropion|
12039991|NCT00285142|Drug|rosiglitazone|
12039992|NCT00285129|Device|ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing|
12039993|NCT00285116|Procedure|Clinical examination and radiological evaluation|
12039994|NCT00285103|Drug|SPC2996|
12039995|NCT00285090|Dietary Supplement|Calcium, Vitamin D|
12039996|NCT00285090|Dietary Supplement|Calcium,Vitamin D|
12039997|NCT00285090|Dietary Supplement|Calcium, VitaminD|
12039998|NCT00285090|Other|Sugar Pill|
12039999|NCT00285077|Drug|SR57667B|
12040000|NCT00285064|Procedure|CT|
12040057|NCT00284518|Biological|botulinum toxin Type A|Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
12040058|NCT00284518|Drug|normal saline|Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
12040059|NCT00284505|Drug|thalidomide|
12040060|NCT00284492|Procedure|Traditional chinese medicine type acupuncture|10 acupuncture sessions
12040061|NCT00284492|Behavioral|Self Care|Lifestyle advice on diet, physical activity
12040062|NCT00284479|Behavioral|Walking 45 mins 2x p.w.|
12040001|NCT00285051|Drug|inhaled delta-8-THC 300mcg or 600mcg per dose|"drugs to be used to prevent/treat nausea and/or vomiting due to cancer chemotherapy drug Patients will receive chemotherapy on day 0 and receive study medication, return on day 1or 2 and again on day 4 to return medication. There will be at least 10 days between the last dose of study medication from the first cycle and the first dose for the 2nd cycle..
~Patients will receive for each chemotherapy cycle either IV Ondansetron and Placebo inhalation, or IV Placebo and delta-8-THC inhalation. The patients will be randomized to receive one of 2 doses of the THC, either 300mcg or THC or 600mcg of THC"
12040002|NCT00285025|Drug|SR57667B|
12040003|NCT00285012|Drug|placebo|1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
12040004|NCT00285012|Drug|Varenicline Tartarate|1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
12040005|NCT00284999|Drug|Soothe|
12040006|NCT00284999|Drug|Refresh Tears|
12040007|NCT00284986|Drug|Prochymal (TM)|Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
12040008|NCT00284973|Biological|Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720|
12040009|NCT00284947|Drug|basiliximab|40 mg once every 28 days intravenously for 24 weeks
12040010|NCT00284947|Drug|MMF/EC-MPS|1g MMF or 720mg EC-MPS p.o twice daily
12040011|NCT00284947|Drug|Corticosteroids|Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
12040012|NCT00284934|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|
12040013|NCT00284934|Drug|Tacrolimus|
12040014|NCT00284934|Drug|Corticosteroids|At a dose of at least 5 mg/day.
12040015|NCT00284921|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12040016|NCT00284908|Drug|S-Tenatoprazole-Na (STU-Na)|30 mg, 60 mg, 90 mg and 120 mg of STU-Na for 5 days every morning
12040017|NCT00284869|Drug|LPS|
12040018|NCT00284856|Drug|montelukast sodium|montelukast 10 mg tablet once daily, 6 month treatment period
12040019|NCT00284856|Drug|Comparator: Placebo|fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
12040020|NCT00284856|Drug|Comparator: fluticasone|fluticasone propionate 250 mcg twice daily, 6 month treatment period
12040021|NCT00284856|Drug|Comparator: Placebo|montelukast 10 mg Pbo tablet once daily, 6 month treatment period
12040022|NCT00284830|Device|Implantable Pulse Generators|dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
12040023|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 1 mg/kg for 51 weeks.
12040024|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.
12040025|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; 6 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.
12040026|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; on Study Day 0 followed by weekly maintenance doses of 3mg/kg for 51 weeks.
12040027|NCT00284817|Drug|MEDI-522|The next cohort of patients will be treated after at least 3 of 4 patients treated in the previous cohort receive at least 3 weeks of treatment and experience no dose-limiting toxicity (DLT).
12040028|NCT00284804|Drug|MDX-060|anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
12040029|NCT00284791|Drug|Lamotrigine (drug)|
12040030|NCT00284791|Drug|Fluoxetine (drug)|
12040031|NCT00284791|Drug|sertraline (drug)|
12040032|NCT00284778|Drug|Alimta®|
12040033|NCT00284778|Drug|Taxotere®|
12040034|NCT00284765|Procedure|flector|
12040035|NCT00284752|Drug|Abraxane|This is a Phase II single-arm study for first-line chemotherapy of patients with hormone refractory metastatic prostate cancer. Eligible patients will be chemotherapy naive and will receive weekly Abraxane 100mg/m2 IV over 30 minutes. These will be 4-week cycles with patients receiving Abraxane 100 mg/m2 weekly for 3 weeks and one week off for rest. Patients will continue on therapy until disease or PSA
12040036|NCT00284739|Drug|Alteplase|2mg or 4mg given twice daily for three days into loculated abscess
12040037|NCT00284739|Other|saline|saline injection twice daily for three days
12040038|NCT00284726|Device|Celsior Cold Storage Solution|
12040039|NCT00284713|Procedure|intracoronary infusion of BMC|catheter delivery of stem cells
12040040|NCT00284700|Drug|Iron|
12040041|NCT00284687|Drug|Artesunate|PO Artesunate
12040042|NCT00284674|Device|Hip prosthesis (re-cap, m2a-magnum and C2a-taper)|
12040043|NCT00284661|Procedure|FAST FIX|Fast fix repair of a meniscal tear
12040044|NCT00284661|Procedure|Meniscal suturing|standard suturing of meniscal tear
12040045|NCT00284648|Procedure|Surgical repair Achilles tendon rupture|
12040046|NCT00284648|Procedure|Non-surgical repair Achilles tendon rupture|
12040047|NCT00284635|Procedure|Fast track vs conventional|
12040048|NCT00284622|Procedure|Arthroscopy|HTO with pre-scope
12040049|NCT00284609|Behavioral|Group based non-pharmacological rehabilitation|"6 x 1.5 hours education program in group classes taught by nurse, physiotherapist, dietitian and chiropodist.
~24 x 1.5 hours training program (both aerobic and anaerobic exercise) in group classes supervised by a physiotherapist.
~3 x 3 hours cooking sessions in group classes supervised by a dietitian.
~Intervention period: 6 month"
12040050|NCT00284609|Behavioral|Individual non-pharmacological rehabilitation|"Individual counseling in Outpatient Clinic, including patient education, physical activity and diet instruction.
~4 x 1 hour with a diabetes nurse,
~3 x 0.5 hour with a dietitian and
~1 hour with a chiropodist.
~Intervention period: 6 month"
12040051|NCT00284596|Procedure|High tibial osteotomy|HTO
12040052|NCT00284583|Drug|Injection of Steroid into Foot|
12040053|NCT00284583|Drug|Injection of Alcohol into Foot|
12040054|NCT00284583|Drug|Injection of Lidocaine into Foot|
12040055|NCT00284557|Behavioral|Group-based behavioral intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
12040063|NCT00284466|Procedure|MS-CT Coronary Angiography|MS-CT Coronary Angiography done
12040064|NCT00284453|Procedure|Peripheral blood sampling|blood samples will be collected within 72 hours of subjects receiving >2, 1-2(low level) or inappropriate therapies, device data and repeat bloodwork in 3 months(+/- 4weeks).
12040065|NCT00284427|Drug|vitamin C|IV Vitamin C given 2-3 times a week
12040066|NCT00284414|Procedure|Ultrasonography or MRI|
12040067|NCT00284401|Procedure|Evaluation of the placement of the Delta prosthesis|
12040068|NCT00284388|Procedure|Simultaneous controlled power measurement|
12040069|NCT00284388|Procedure|Surface EMG measurement|
12040070|NCT00284375|Procedure|Registration of all big toe prostheses in Ghent University Hospital|Registration of all big toe prostheses in Ghent University Hospital.
12040071|NCT00284362|Procedure|Arthroscopic or open surgery for hallux rigidus|
12040072|NCT00284349|Device|Use of a rehabilitation brace instead of a plaster|
12040073|NCT00284336|Drug|Caelyx|
12040074|NCT00284336|Drug|endoxan|
12040075|NCT00284323|Drug|Adenosine|
12040076|NCT00284310|Procedure|Anamnesis and clinical examination|Anamnesis and clinical examination to follow.
12040077|NCT00284297|Procedure|History taken and clinical examination|History is taken and clinical examination is followed
12040078|NCT00284284|Device|Use of a rehabilitation brace|
12040079|NCT00284271|Drug|Cyclophosphamide|
12040080|NCT00284271|Drug|Adramycin|
12040081|NCT00284271|Drug|Procarbacine|
12040082|NCT00284271|Drug|Prednisone|
12040083|NCT00284271|Drug|Vincristine|
12040084|NCT00284271|Drug|Bleomycin|
12040085|NCT00284271|Drug|Erythropoietin beta|
12040086|NCT00284258|Drug|CPT-11 and TS-1|TS-1 was administered orally at 40-60 mg twice daily for 14 days with a rest period of 14 days as one course. CPT-11 was administered intravenously 125 mg per square meter at day1 and day14 in 4 weeks as one course.
12040087|NCT00284258|Drug|CPT-11, 5-FU and l-LV|Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks.
12040088|NCT00284232|Behavioral|Use and interpretation of blood glucose results|
12040089|NCT00284232|Drug|Insulin dosing based on SMBG chart and education|
12040090|NCT00284219|Device|Transcranial Magnetic Stimulation 10Hz|3. rTMS subjects will receive 20 trains of rTMS at a rate of 10 Hz for 6 seconds (1200 pulses/session). Pulses will be administered over the left dorsolateral prefrontal cortex, defined as 5 cm anterior and in a parasagital plane to the point of maximum stimulation of the abductor pollicis muscle. Pulse intensity will be set at 100% motor threshold.
12040091|NCT00284219|Device|Magnetic stimulation using a special sham coil|Sham stimulation will be given at the same location as the active, with special sham coil.
12040092|NCT00284206|Drug|long-acting injectable risperidone|
12040093|NCT00284193|Drug|rFVIIa-FEIBA therapy for hemophilia A inhibitors|DOses tailored per ex vivo spiking thrombin generation
12040094|NCT00284193|Drug|FEIBA- Activated Prothrombin Complexes|
12040095|NCT00284180|Drug|Vinflunine|Novel second generation vinca alkaloid
12040096|NCT00284180|Drug|Trastuzumab|Anti-HER2 monoclonal antibody
12040097|NCT00284167|Behavioral|tailored web-based weight management intervention|
12040098|NCT00284154|Drug|Vinflunine|320mg/m2 every 21 days as a 15-20 minute infusion
12040099|NCT00284141|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|"Aflibercept 4.0 mg/kg administered intravenously (IV) over a period of at least 1 hour once every 2 weeks.
~Aflibercept could be reduced by 1 dose level (to 3.0 mg/kg) or 2 dose levels (to 2.0 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
12040100|NCT00284128|Drug|AVE7688|oral administration (capsules)
12040101|NCT00284128|Drug|Losartan-potassium|oral administration (capsules)
12040102|NCT00284115|Device|Gait trainer|Mechanical gait repetitive training
12040103|NCT00284115|Device|Conventional rehabilitation|Physiotherapeutic conventional rehabilitation
12040104|NCT00284102|Procedure|Mechanical ventilation|measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)
12040105|NCT00284089|Drug|Ranibizumab|Ranibizumab was administered by intravitreal injection in the study eye. Intravitreal injection was performed by the investigator following slitlamp examination.
12040106|NCT00284076|Drug|L-arginine|
12040107|NCT00284063|Procedure|Low back adjustment and MRI|Subjects received a 15 minutes MRI in neutral position, a chiropractic low back spinal manipulation, and a second 15 minute MRI in neutral position.
12040108|NCT00284063|Procedure|Low back adjustment and MRI|Subjects received a 15 minutes MRI in neutral position, a chiropractic spinal manipulation to the low back, and a second 15 minute MRI in a side posture position.
12040109|NCT00284063|Procedure|MRI|Subjects received a 15 minute MRI in neutral position and a second 15 minute MRI in neutral position.
12040110|NCT00284050|Drug|Ranibizumab 0.3 mg|6 mg/ml ranibizumab solution for intravitreal injection
12040111|NCT00284050|Drug|Ranibizumab 0.5 mg|10 mg/ml ranibizumab solution for intravitreal injection
12040112|NCT00284050|Drug|Sham injection|Non-treatment control for sham intravitreal injection.
12040113|NCT00284037|Device|continuous positive airway pressure therapy|
12040114|NCT00284024|Drug|domperidone|
12040115|NCT00284011|Dietary Supplement|SAMe|800 mg dose daily for 4 weeks.
12040116|NCT00284011|Other|Placebo|2 placebo pills daily for 4 weeks.
12040117|NCT00283998|Procedure|surgical versus conservative treatment|Surgical treatment of fractures versus conservative stabilization
12040118|NCT00283985|Drug|Kidrolase|6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles.
12040119|NCT00283985|Drug|Methotrexate|3 gr/m2 at J1
12040120|NCT00283985|Drug|Dexamethasone|40 mg/ per os at J1, J2 and J4.
12040121|NCT00283985|Drug|Erwinase|"In case of allergy to Kidrolase
~20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles"
12040122|NCT00283972|Device|LAP-BAND System|
12040128|NCT00283855|Behavioral|Online Self-Management|Online Self-Management
12040129|NCT00283842|Drug|DVS SR|
12040130|NCT00283842|Drug|Placebo|
12040131|NCT00283829|Drug|docetaxel|chemotherapy
12040132|NCT00283829|Drug|IL2|immunotherapy
12040133|NCT00283816|Drug|Metformin|Metformin 500 mg. tabs 2 tabs BID for duration of study
12040134|NCT00283816|Drug|Oral Contraceptive Pill|"Yasmin, drospirenone and ethinyl estradiol 28 tablets
~1 tab daily for duration of study"
12040135|NCT00283816|Behavioral|Lifestyle Management Program|Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise & behavior modification skills on a regular weekly basis over the 24 week study
12040136|NCT00283816|Behavioral|Quality of Life Questionnaire|Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion
12040137|NCT00283816|Procedure|Oral Glucose Tolerance Test|"Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance.
~Performed twice during study, at baseline and conclusion"
12040138|NCT00283816|Procedure|Blood work|Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.
12040139|NCT00283816|Procedure|Abdominal Ultra Sound|"transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume.
~Performed twice during study, at baseline and conclusion"
12040140|NCT00283816|Procedure|Dual-energy x-ray absorptiometry (DEXA scan)|Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion
12040141|NCT00283816|Drug|placebo|placebo capsules, two capsules BID
12040142|NCT00283803|Drug|Exisulind|Oral antineoplastic agent that induces apoptosis in cancerous cells.
12040143|NCT00283803|Drug|luteinizing hormone-releasing hormone (LHRH) agonist|Hormonal therapy to suppress testosterone as a standard treatment for Prostate Cancer.
12040144|NCT00283803|Drug|Antiandrogen|Hormonal therapy used as lead in treatment with luteinizing hormone-releasing hormone (LHRH) agonist to prevent the initial rise in testosterone (testosterone flare) seen during the first dose of LHRH agonists.
12040145|NCT00283790|Drug|zolpidem tartrate|
12040146|NCT00283777|Drug|Chromium Picolinate|
12040147|NCT00283764|Drug|Xalatan|
12040148|NCT00283751|Drug|insulin detemir|
12040149|NCT00283751|Drug|insulin glargine|
12040150|NCT00283738|Device|BioSTAR Septal Repair Implant System|PFO Closure
12040151|NCT00283738|Procedure|Sham Procedure|Catheterization
12040152|NCT00283725|Other|No intervention|Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine).
12040153|NCT00283712|Drug|Infliximab|Chimeric IgG monoclonal antibody that binds to TNF-alpha, generally used to treat Crohn's disease, given in a dosage of 5 mg/kg
12040154|NCT00283712|Other|Placebo Comparator|Placebo administered in place of infliximab for control group
12040155|NCT00283699|Drug|albendazole|Active drug or placebo dosed bid p o for 8days
12040156|NCT00283699|Other|placebo|an inactive substance
12040157|NCT00283686|Drug|Lisinopril|Lisinopril titrated to 5mg, 10mg, 20mg, 40mg
12040158|NCT00283686|Drug|Telmisartan|Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
12040159|NCT00283686|Drug|Placebo|Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
12040160|NCT00283686|Other|Standard Blood Pressure Control|Achieve standard blood pressure control of 120-130/70-80 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
12040161|NCT00283686|Other|Low Blood Pressure Control|Achieve low blood pressure control of 95-110/60-75 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
12040162|NCT00283673|Behavioral|Exercise|
12040163|NCT00283660|Dietary Supplement|10 mg zinc oxide|10 mg zinc oxide
12040164|NCT00283660|Other|Placebo|Placebo pill taken five days a week for six months.
12040165|NCT00283634|Drug|erlotinib and bortezomib|
12040166|NCT00283621|Drug|Aranesp (darbepoetin alfa)|
12040167|NCT00283621|Drug|Neulasta (pegfilgrastim)|
12040168|NCT00283621|Drug|Adriamycin|
12040169|NCT00283621|Drug|Ifosfamide|
12040170|NCT00283608|Genetic|Single nucleotide polymorphism (SNP)|Evaluating SNP association with traits.
12040171|NCT00283608|Other|high performance liquid chromatography|analysis of plasma concentrations of drugs
12040172|NCT00283608|Other|measurements by DXA|determine bone mineral density (BMD)
12040173|NCT00283608|Other|questionnaire administration|determine attitude changes
12040174|NCT00283595|Drug|Recombinant Human Growth Hormone|Dosage increased in steps for first four weeks. Self injection qd x 12 weeks
12040175|NCT00283595|Drug|Placebo for Recombinant Human Growth Hormone|Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
12040176|NCT00283582|Drug|rhTPO|
12040177|NCT00283569|Other|Mouth Swab, Toe Nail Clippings, Questionnaires|The objective of this study is to establish a clinic based case control study for examination of potential risk factors for primary adult brain tumors.
12040178|NCT00283556|Drug|Irinotecan (Camptosar, CPT-11)|"Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients.
~Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached."
12040179|NCT00283543|Drug|Gliadel Wafer|
12040180|NCT00283543|Drug|Temozolomide|
12040181|NCT00283543|Procedure|Limited field radiation|
12040182|NCT00283530|Procedure|Tumor biopsy|
12040183|NCT00283517|Drug|antipsychotics|as prescribed
12040353|NCT00282126|Dietary Supplement|Potassium citrate|kcitrate
12040184|NCT00283504|Drug|ANTI-IGE THERAPY (XOLAIR)|Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
12040185|NCT00283491|Behavioral|Active Lactobacillus plantarum 299v|10^11 cfu/meal in 2 meals on 2 consecutive days
12040186|NCT00283491|Dietary Supplement|Inactive Lactobacillus plantarum 299v|Inactive form of the active treatment but with the fermentation products in the same concentration
12040187|NCT00283478|Drug|Iscar Quercus|
12040188|NCT00283478|Drug|Gemcitabine|
12040189|NCT00283465|Drug|Epoetin alfa|
12040190|NCT00283452|Behavioral|Phone counseling with written materials|Participation in phone/mail counseling to maintain physical activity
12040191|NCT00283439|Biological|AMG 531|"Planned Cohorts:
~100 mcg,
~300 mcg,
~700 mcg,
~1000 mcg;
~Optional Cohorts:
~cohort expansion,
~schedule change,
~new dose"
12040192|NCT00283426|Drug|Soluble beta-1,3/1,6-glucan|
12040193|NCT00283413|Device|Covered Stent System|Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
12040194|NCT00283413|Device|Bare metal stent|Any commercially available bare metal stent for coronary indication
12040195|NCT00283400|Drug|25% human albumin|25% human albumin: after approval by the Data and Safety Monitoring Board dosage tier would be escalated to the subsequent higher level sequentially.
12040196|NCT00283387|Drug|Betaine|Subjects were randomly assigned oral betaine 12 grams/day in subjects younger than 10 years of age, and 20 grams/day in subjects 10 years of age and older, in two divided doses, for 2 months.
12040197|NCT00283387|Drug|Placebo|Subjects received oral lactose placebo, in two doses daily, for 2 months.
12040198|NCT00283374|Procedure|Laparoscopic Roux-en-Y Gastric Bypass|
12040199|NCT00283361|Drug|ZP120|
12040200|NCT00283361|Procedure|I.v. catherization|
12040201|NCT00283361|Procedure|6-minutes walk performance|
12040202|NCT00283361|Behavioral|Dyspnea severity assessment|
12040203|NCT00283361|Procedure|Blood sampling for laboratory tests|
12040204|NCT00283361|Procedure|ECG|
12040205|NCT00283361|Procedure|Physical examination|
12040206|NCT00283335|Drug|gemfibrozil|
12040207|NCT00283335|Other|Placebo|Matching placebo tablets taken once per day
12040208|NCT00283322|Other|blood samples (2)|Two blood samples were obtained from patients and tested for heparin antibodies.
12040209|NCT00283309|Drug|Memantine|
12040210|NCT00283309|Drug|Riluzole|
12040211|NCT00283296|Device|Endeavor|Collapsible, forward folding manual wheelchair
12040212|NCT00283283|Biological|Fluzone® (Aventis Pasteur inactivated influenza vaccine)|A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
12040213|NCT00283270|Behavioral|Brief counselling|
12040214|NCT00283270|Behavioral|Behavior|
12040215|NCT00283257|Behavioral|Patients and caregivers are taught problem solving skills|
12040216|NCT00283244|Drug|erlotinib hydrochloride|given orally
12040217|NCT00283244|Drug|gemcitabine hydrochloride|given IV
12040218|NCT00283231|Behavioral|Paced Respiration|
12040219|NCT00283218|Drug|NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70|
12040220|NCT00283205|Behavioral|Yoga|
12040221|NCT00283192|Drug|Sertraline|
12040222|NCT00283179|Drug|Aripiprazole|
12040223|NCT00283179|Drug|Risperidone|
12040224|NCT00283166|Behavioral|Tailored Education and Coaching|A: Patients receive one-on-one counseling and education about pain management and improving doctor-patient communication B: Patients receive booklet on cancer pain control
12040225|NCT00283153|Behavioral|Facial Affect Recognition Training|A series of pictures of faces displaying various emotions are presented one at a time using a computerized training program.Participants are taught to recognize how emotions affect facial features such as the mouth and eyes.Participants are also taught how to recognize their own emotions.
12040226|NCT00283153|Other|Stories of Emotional Inference|Participants are presented with a series of short stories one at a time. Each story presents various contextual cues regarding the emotions the characters are likely to experience. Participants learn to connect the cues to specific emotions.
12040227|NCT00283127|Procedure|Home sampling (urine test) for uro-genital C.trachomatis.|
12040228|NCT00283114|Drug|lintuzumab|1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles
12040229|NCT00283101|Drug|SGN-40 (anti-huCD40 mAb)|1-8 mg/kg IV; Days 1, 4, 8, 15, 22, 29 of Cycle 1 and Days 1, 15, 29 and 43 of Cycles 2-6.
12040230|NCT00283088|Procedure|hypothermia|"Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.
~Subjects are stratified by time to six groups."
12040231|NCT00283088|Drug|tissue plasminogen activator|tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
12040232|NCT00283075|Biological|Cancer Macrobead placement in abdominal cavity|8 macrobeads per kg
12040233|NCT00283062|Drug|Docetaxel (TAXOTERE®) Chemotherapy|"75 mg/m^2 docetaxel administered intravenously over 1 hour on Day 1 every three weeks (q3w) for 6 cycles. The first cycle was to be administered within 8 days after randomization.
~Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy."
12040234|NCT00283062|Drug|Leuprolide acetate ( ELIGARD®) Hormonal Therapy|22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 8 days after randomization.
12040235|NCT00283062|Drug|Docetaxel (TAXOTERE®) Chemotherapy|"75 mg/m^2 docetaxel administered IV over 1 hour on Day 1 q3w for 6 cycles. The first cycle was to be administered within 30 days after progression was confirmed.
~Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy."
12040473|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
12040236|NCT00283062|Drug|Leuprolide acetate ( ELIGARD®) Hormonal Therapy|22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed (on Day 1 of docetaxel administration).
12040237|NCT00283062|Drug|Leuprolide acetate ( ELIGARD®) Hormonal Therapy|22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed.
12040238|NCT00283049|Drug|Insulin Glargine|Insulin glargine administered subcutaneously once daily.
12040239|NCT00283049|Drug|Insulin Glulisine|Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
12040240|NCT00283036|Drug|Irbesartan|
12040241|NCT00283023|Procedure|Oligodendrocyte progenitor cell culture/craniotomy|Oligodendrocyte progenitor cell culture protocol of Rajavithi Hospital will be apply
12040242|NCT00283010|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
12040243|NCT00283010|Other|Educational DVDs|
12040244|NCT00282997|Drug|pregabalin|
12040245|NCT00282984|Drug|placebo|1 mg placebo twice daily by mouth for 12 weeks
12040246|NCT00282984|Drug|Varenicline|1 mg twice daily by mouth for 12 weeks
12040247|NCT00282971|Drug|Inhaled Insulin (Exubera)|Addition of inhaled insulin to pre-existing oral diabetes therapy.
12040248|NCT00282971|Other|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
12040249|NCT00282958|Drug|Botulinum Toxin type a (Botox)|
12040250|NCT00282945|Drug|Rosiglitazone|
12040251|NCT00282945|Drug|Metformin|
12040252|NCT00282932|Drug|Detrol LA|
12040253|NCT00282919|Drug|Azithromycin plus chloroquine|dose of 2000 mg Azithromycin plus 600 mg chloroquine base
12040254|NCT00282906|Device|hybrid PET-CT imaging system|15 mCi of FDG
12040255|NCT00282893|Procedure|transluminal ballooning|
12040256|NCT00282893|Other|currently existing therapies for the treatment of vasospasm|
12040257|NCT00282867|Drug|IV glucose insulin and potassium, GIK|The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
12040258|NCT00282867|Other|standard care|usual care
12040259|NCT00282841|Other|ultrasound|single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound.
12040260|NCT00282828|Drug|Sertraline|
12040261|NCT00282828|Drug|Venlafaxine|
12040262|NCT00282828|Drug|Placebo|
12040263|NCT00282828|Drug|Clonazepam|
12040264|NCT00282815|Device|continuous positive airway pressure or CPAP|RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
12040265|NCT00282815|Device|sham CPAP|sham CPAP
12040266|NCT00282789|Device|bilevel positive airway pressure|
12040267|NCT00282789|Device|bilevel positive airway pressure (Device)|
12040268|NCT00282776|Behavioral|Care Management for Postpartum Depression|Depression Care Manager calls postpartum women and encourages women to seek appropriate depression care. In this context the depression care manager helps the women to identify barriers to appropriate care, her preferred method of care, and resources available. Calls are made initially at 2 calls per month, followed by one call per month and calls every other month for women who are doing well. Women assigned to this group receive research assessments at 3, 6, and 12 months postpartum. They also receive information about community and health plan resources available for women with depression.
12040269|NCT00282776|Behavioral|TAU|Participants receive treatment as usual for postpartum depression. Women assigned to this arm receive research assessments at 3, 6, and 12 months postpartum. At the baseline home visit where diagnostic assessments are completed women are given information about community and health plan resources if they choose to seek care for depression symptoms. Women are also given phone contact numbers for the research program.
12040270|NCT00282763|Drug|MK0686|
12040271|NCT00282750|Device|Bar coded sponge and scanner|
12040272|NCT00282724|Drug|Liarozole|
12040273|NCT00282698|Drug|Insulin infusion with a goal|
12040274|NCT00282685|Procedure|Intraarterial bone marrow progenitor cell transplantation|catheter delivery of stem cells
12040275|NCT00282672|Device|Ablation System plus anti-secretory medication|Treatment group subjects undergo up to 4 ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI).
12040276|NCT00282672|Device|Sham procedure plus anti-secretory medication|The Sham Control group undergo an upper endoscopy procedure with sizing of the esophageal diameter (a component of the ablation procedure steps, deemed the sham procedure) plus standard anti-secretory drug therapy (Proton pump inhibitor, PPI)
12040277|NCT00282659|Drug|magnesium L-lactate|
12040278|NCT00282646|Procedure|intraarterial stem cell therapy|catheter delivery of stem cells
12040279|NCT00282646|Other|Stem cells|intraarterial application of bone marrow mononuclear cells versus placebo
12040280|NCT00282633|Device|Dermabond|
12040281|NCT00282620|Drug|Magnesium L-lactate|
12040282|NCT00282607|Drug|DA-8159|
12040283|NCT00282594|Drug|Novolin R (human recombinant Insulin)|
12040284|NCT00282581|Biological|MVA Smallpox Vaccine|0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
12040285|NCT00282568|Drug|Tacrolimus Modified Release (MR)|Oral
12040286|NCT00282568|Drug|tacrolimus|Oral
12040287|NCT00282555|Drug|S-Tenatoprazole-Na (STU-Na)|
12040288|NCT00282542|Procedure|Hepatocyte Infusion|
12040289|NCT00282529|Device|High Risk Lymphedema Education and Device Intervention|
12040290|NCT00282516|Procedure|In-home telemonitoring of pediatric patients with persistent asthma|
12040350|NCT00282152|Device|B-STN DBS|Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
12040536|NCT00281177|Behavioral|Asthma Disparity Reduction Strategy|
12040291|NCT00282503|Drug|Methoxsalen+ECP, Methylprednisolone|"Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:
~Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
~Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be > 4 days between the ECP treatments within a week.)
~Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions:
~Daily Dose (mg/kg)
~1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10"
12040292|NCT00282503|Procedure|Ecp|ECP or Extra Corporeal Phototherapy will be used with UVADex
12040293|NCT00282490|Device|Nerve stimulator|
12040294|NCT00282464|Drug|Placebo|Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.
12040295|NCT00282464|Drug|Geodon (Ziprasidone)|Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
12040296|NCT00282451|Drug|biphasic insulin aspart|
12040297|NCT00282451|Drug|insulin aspart|
12040298|NCT00282438|Biological|Autologous hematopoietic stem cell transplantation|Autologous hematopoietic stem cells will be injected after conditioning
12040299|NCT00282438|Biological|Allogeneic stem cell transplantation|Allogeneic stem cells will be injected after conditioning
12040300|NCT00282425|Biological|Hematopoietic stem cell transplantation|Allogeneic Hematopoietic stem cell transplantation
12040301|NCT00282412|Biological|Hematopoietic Stem Cell Transplantation|Allogeneic Hematopoietic Stem Cell Transplantation
12040302|NCT00282412|Drug|Fludarabine|inhibits DNA synthesis or repair
12040303|NCT00282412|Drug|Cyclophosphamide|Causes prevention of cell division by forming adducts with DNA
12040304|NCT00282412|Drug|Campath 1H|humanized monoclonal antibody against CD52 antigen
12040305|NCT00282412|Drug|GCSF|Hematopoietic growth factor
12040306|NCT00282412|Drug|Cyclosporins|immune suppressive drug
12040307|NCT00282412|Drug|Mycophenolate Mofetil|immune suppressive drug
12040308|NCT00282399|Drug|Subcutaneous Decitabine|
12040309|NCT00282386|Drug|MK0966; Rofecoxib / Duration of Treatment: 156 weeks|
12040310|NCT00282386|Drug|Placebo/ Duration of Treatment: 156 weeks|
12040311|NCT00282373|Device|mild hypothermia|
12040312|NCT00282360|Drug|Trimetazidine|
12040313|NCT00282347|Drug|Rituximab|Rituximab was provided as a sterile solution for injection.
12040314|NCT00282347|Drug|Placebo|Placebo was provided as a sterile solution for injection.
12040315|NCT00282347|Drug|Mycophenolate mofetil|
12040316|NCT00282347|Drug|Methylprednisolone|
12040317|NCT00282347|Drug|Diphenhydramine|
12040318|NCT00282347|Drug|Acetaminophen|
12040319|NCT00282347|Drug|Prednisone|
12040320|NCT00282334|Device|Telemedical blood pressure monitoring|Measurement of home blood pressure, three times per week for three months and once a week for three months.
12040321|NCT00282321|Behavioral|High Protein diet|
12040322|NCT00282321|Behavioral|High carbohydrate diet|
12040323|NCT00282308|Drug|Rituximab|Rituximab was supplied in single-use vials.
12040324|NCT00282308|Drug|Methotrexate|
12040325|NCT00282308|Drug|Methylprednisone|Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
12040326|NCT00282308|Biological|C. albicans|Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm.
12040327|NCT00282308|Biological|Tetanus toxoid adsorbed booster vaccine|Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle.
12040328|NCT00282308|Biological|23-valent pneumococcal polysaccharide vaccine|Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle.
12040329|NCT00282308|Biological|Keyhole limpet hemocyanin|Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg)
12040330|NCT00282295|Biological|Boostrix®|GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
12040331|NCT00282295|Biological|Menactra™|Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
12040332|NCT00282282|Drug|tacrolimus|Given orally just prior to and following stem cell transplant
12040333|NCT00282282|Drug|sirolimus|Given orally just prior to and following stem cell transplant
12040334|NCT00282282|Drug|fludarabine|Given once daily over 30 minutes for 4 days
12040335|NCT00282282|Drug|busulfex|Given intravenously over 3 hours for 4 days
12040336|NCT00282269|Procedure|Induced Hypothermia|Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours
12040337|NCT00282256|Drug|tacrolimus modified release (MR)|Oral
12040338|NCT00282256|Drug|tacrolimus|Oral
12040339|NCT00282243|Drug|tacrolimus modified release (MR)|Oral
12040340|NCT00282243|Drug|tacrolimus|Oral
12040341|NCT00282230|Drug|FK778|
12040342|NCT00282217|Drug|Sirolimus|
12040343|NCT00282204|Behavioral|antenatal hypnosis + audio compact disc on hypnosis|
12040344|NCT00282204|Behavioral|Audio compact disc on hypnosis|
12040345|NCT00282178|Drug|Hydrochlorothiazide|25-50 mg once daily
12040346|NCT00282178|Drug|Placebo|Once daily
12040347|NCT00282178|Drug|Candesartan|16-32 mg once daily 12 weeks
12040348|NCT00282165|Drug|naratriptan|four weeks double blind experimental treatment using oral naratriptan
12040349|NCT00282165|Drug|placebo|four weeks double blind placebo treatment
12040351|NCT00282152|Drug|Optimal drug therapy|The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
12040352|NCT00282139|Drug|Aripiprazole|
12040354|NCT00282113|Dietary Supplement|ProBioPlus|ProBioPlus is advertised as containing Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium infantis, and Bifidobacterium bifidum plus inulin. The dose given was 5 x 10e8 twice daily.
12040355|NCT00282113|Dietary Supplement|Culturelle|Culturelle is advertised as containing Lactobacillus rhamnosus GG. The dose was 5 x 10e8 twice daily.
12040356|NCT00282113|Other|Placebo|A dilute preparation of pregestimil powder formulated to have a similar appearance to the probiotic products
12040357|NCT00282100|Drug|Gefetinib (Iressa)|
12040358|NCT00282087|Drug|gemcitabine, docetaxel, doxorubicin|Cycles = 28 days
12040359|NCT00282074|Procedure|laparoscopic bilateral hernia repair|
12040360|NCT00282061|Drug|Melatonin|
12040361|NCT00282048|Drug|AG-013736 (axitinib)|AG-013736 5 mg twice daily [bid] continuous dosing in 28 day cycles.
12040362|NCT00282035|Radiation|APBI utilizing 3D-CRT radiation|Accelerated partial breast irradiation utilizing 3D-CRT
12040363|NCT00282035|Radiation|Whole breast irradiation|Whole breast irradiation
12040364|NCT00282022|Drug|laromustine|
12040365|NCT00282009|Behavioral|Basic Internet|Basic Internet control intervention
12040366|NCT00282009|Behavioral|Enhanced Internet|enhanced Internet cessation intervention
12040367|NCT00282009|Behavioral|Enhanced Internet + phone|enhanced Internet plus proactive telephone counseling
12040368|NCT00281996|Drug|Gemcitabine|Administered intravenously over 30 minutes on days 1 and 8 of a 21-day cycle starting at a dose of 700 mg/m2 and increasing to 1000mg/m2 by cohorts
12040369|NCT00281996|Drug|Imatinib mesylate|Administered orally once daily with 8 ounces of water at a starting dose of 300 mg/day and increased to 600 mg/day according to cohort.
12040370|NCT00281983|Biological|alemtuzumab|
12040371|NCT00281983|Biological|anti-thymocyte globulin|
12040372|NCT00281983|Biological|filgrastim|
12040373|NCT00281983|Biological|rituximab|
12040374|NCT00281983|Biological|therapeutic allogeneic lymphocytes|
12040375|NCT00281983|Drug|busulfan|
12040376|NCT00281983|Drug|cyclophosphamide|
12040377|NCT00281983|Drug|cyclosporine|
12040378|NCT00281983|Drug|fludarabine phosphate|
12040379|NCT00281983|Drug|methotrexate|
12040380|NCT00281983|Drug|mycophenolate mofetil|
12040381|NCT00281983|Procedure|peripheral blood stem cell transplantation|
12040382|NCT00281983|Radiation|radiation therapy|
12040383|NCT00281970|Drug|cisplatin|
12040384|NCT00281970|Drug|docetaxel|
12040385|NCT00281970|Procedure|adjuvant therapy|
12040386|NCT00281957|Drug|sorafenib tosylate|Given orally
12040387|NCT00281957|Drug|tipifarnib|Given orally
12040388|NCT00281957|Drug|temsirolimus|Given IV
12040389|NCT00281944|Drug|oxaliplatin|Given IV
12040390|NCT00281944|Drug|fluorouracil|Given IV
12040391|NCT00281944|Drug|leucovorin calcium|Given IV
12040392|NCT00281944|Other|pharmacological study|Correlative studies
12040393|NCT00281944|Procedure|positron emission tomography|Undergo PET scan
12040394|NCT00281944|Procedure|computed tomography|Undergo PET/CT scan
12040395|NCT00281931|Biological|rituximab|
12040396|NCT00281931|Drug|cyclophosphamide|
12040397|NCT00281931|Drug|fludarabine phosphate|
12040398|NCT00281918|Drug|Rituximab|Intravenous repeating dose
12040399|NCT00281918|Drug|Cyclophosphamide|Intravenous repeating dose
12040400|NCT00281918|Drug|Fludarabine Phosphate|Intravenous repeating dose
12040401|NCT00281905|Drug|carboplatin|
12040402|NCT00281905|Drug|cisplatin|
12040403|NCT00281905|Drug|cyclophosphamide|
12040404|NCT00281905|Drug|methotrexate|
12040405|NCT00281905|Drug|vincristine sulfate|
12040406|NCT00281905|Radiation|radiation therapy|
12040407|NCT00281892|Biological|Fludarabine plus Darbopoetin|Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks
12040408|NCT00281892|Drug|Fludarabine mono|"Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support.
~Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa."
12040409|NCT00281879|Biological|anti-thymocyte globulin|Intravenous, 1.5 mg/kg of body weight daily for 7 to 14 days The first dose should be administered over a minimum of 6 hours and over at least 4 hours on subsequent doses through a high-flow vein.
12040410|NCT00281879|Biological|filgrastim|"Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused.
~Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion."
12040411|NCT00281879|Drug|busulfan|Patients who take the drug PO, busulfan will be administered at 1 mg/kg/ dose given by mouth every 6 hours for 16 consecutive doses. Pediatric patients who receive busulfan IV continuous infusion will receive a dose of 3.0 mg/kg/IBW if under the age of 2.Pediatric patients over the age of 2 will receive busulfan at a dose of 0.8 mg/kg/dose.
12040412|NCT00281879|Drug|carmustine|300mg/m2 IV dissolved in 500 cc NS infused over 2 hours into right atrial catheter on day -6.
12040413|NCT00281879|Drug|cyclophosphamide|For transplantation, the drug is diluted in 250 to 500 cc of NS or D5W and administered IV over 2 hours.
12040414|NCT00281879|Drug|cyclosporine|Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID. The infusion will vary from 2-24hr depending on the incidence of side-effects.
12040415|NCT00281879|Drug|cytarabine|400 mg/m2 dissolved in 200cc D5W and infused over 30 minutes into right atrial catheter on days -5, -4, -3, -2.
12040474|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
12040475|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
12040416|NCT00281879|Drug|etoposide|"Etoposide administration 200 mg /m2 dissolved in 1 liter NS and infused over 2 hours into right atrial catheter. Infusion to begin after cytarabine administration on days -5, -4, -3, -2.
~Etoposide administration 50 mg/kg IV over 24 hours, divided into 3 doses. Dilute in normal saline at a concentration of 0.4 mg/ml (Observe for precipitation). Administered IV with continuous infusion over 24 hours. Diuretics may be given for fluid overload."
12040417|NCT00281879|Drug|fludarabine phosphate|"Fludarabine administered at 30 mg/m2 IVPB infused over 30 minutes into right atrial catheter on days -4, -3, -2.
~Fludarabine administered at 40 mg/m2 IVPB infused over 30 into the right atrial catheter on days -5, -4, -3, and -2."
12040418|NCT00281879|Drug|melphalan|140 mg /m2 in concentration of 0.45 mg/ml of NS infused over 30 minutes into right atrial catheter on day -1.
12040419|NCT00281879|Drug|methotrexate|Administered on days +1, +3, and +7.
12040420|NCT00281879|Drug|methylprednisolone|Methyl-prednisolone is administered IV as a rapid infusion.
12040421|NCT00281879|Drug|mycophenolate mofetil|Mycophenolate may be used as a substitute for Methotrexate
12040422|NCT00281879|Drug|tacrolimus|A drug used to decrease the risk of graft versus host disease (GvHD).
12040423|NCT00281879|Procedure|peripheral blood stem cell transplantation|The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy. The stem cell infusion takes 1-6 hours.
12040424|NCT00281879|Procedure|umbilical cord blood transplantation|The patient will receive ATG to improve the changes of engraftment and decrease their risk of graft versus host disease. The patient may receive ATG 3 times during their transplant regimen on days -3 through days -1
12040425|NCT00281879|Radiation|radiation therapy|Radiation will be given to you 2 times a day for 3 or 4 days.
12040426|NCT00281866|Drug|erlotinib hydrochloride|
12040427|NCT00281853|Procedure|management of therapy complications|Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
12040428|NCT00281840|Biological|bevacizumab|Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.
12040429|NCT00281840|Drug|docetaxel|docetaxel IV over 1 hour once a week for 8 weeks
12040430|NCT00281840|Procedure|conventional surgery|8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection
12040431|NCT00281840|Radiation|radiation therapy|radiotherapy once daily, 5 days a week, for 8 weeks
12040432|NCT00281827|Drug|carboplatin|Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
12040433|NCT00281827|Drug|gemcitabine hydrochloride|Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
12040434|NCT00281827|Drug|thalidomide|Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.
12040435|NCT00281827|Procedure|conventional surgery|Resection - between 2 and 6 weeks following last dose of chemotherapy.
12040436|NCT00281814|Procedure|psychosocial assessment and care|psychosocial assessment and care
12040437|NCT00281801|Procedure|psychosocial assessment and care|psychosocial assessment and care
12040438|NCT00281801|Procedure|Quality of Life Assessments|PACT Scale, Brief COPE, POMS Short Form and FACT BMT
12040439|NCT00281788|Drug|capecitabine|
12040440|NCT00281788|Drug|carboplatin|
12040441|NCT00281788|Drug|paclitaxel|
12040442|NCT00281788|Radiation|radiation therapy|
12040443|NCT00281762|Drug|NSAID|
12040444|NCT00281749|Procedure|TELEPHONE CALL|
12040445|NCT00281736|Drug|HPPH|Given IV
12040446|NCT00281723|Drug|Pro-Pe adhesive tablet|
12040447|NCT00281710|Drug|Methylprednisolone|
12040448|NCT00281697|Drug|Bevacizumab|The dose of bevacizumab was based on a patient's weight at baseline and remained the same throughout the study.
12040449|NCT00281697|Drug|Placebo|
12040450|NCT00281697|Drug|Standard chemotherapy|"Patients received one of the following four standard chemotherapies for metastatic breast cancer.
~Taxane - Paclitaxel (Taxol) 90 mg/m^2 IV every week for 3 weeks followed by 1 week of rest; paclitaxel (Taxol) 175 mg/m^2 IV every 3 weeks, or paclitaxel protein-bound particles (Abraxane) 260 mg/m^2 IV every 3 weeks; or docetaxel (Taxotere) 75-100 mg/m^2 IV every 3 weeks.
~Gemcitabine (Gemzar) 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle.
~Vinorelbine (Navelbine) 30 mg/m^2 IV every week of each 3-week cycle.
~Capecitabine (Xeloda) 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week cycle."
12040451|NCT00281684|Drug|SB705498 400 mg|SB705498 400 mg
12040452|NCT00281684|Drug|SB705498 1000 mg|SB705498 1000 mg
12040453|NCT00281684|Drug|Placebo|Placebo
12040454|NCT00281684|Drug|Co-Codamol|Co-Codamol
12040455|NCT00281671|Drug|nesiritide|nesiritide 0.015 mcg/kg/hour x 10 hours
12040456|NCT00281671|Drug|Placebo|0.9% sodium chloride infusion
12040457|NCT00281658|Drug|lapatinib (GW572016) oral tablets|1500 mg oral daily continuously
12040458|NCT00281658|Drug|paclitaxel infusion|Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months
12040459|NCT00281645|Drug|Bicifadine|
12040460|NCT00281645|Drug|Standard of Care (pharmacological analgesic treatment)|
12040461|NCT00281632|Drug|GW786034|800 mg GW786034 administered orally on a daily basis.
12040462|NCT00281619|Drug|CellCept (mycophenolate mofetil)|
12040463|NCT00281619|Behavioral|Dietary Monitoring|
12040464|NCT00281619|Behavioral|Drug Diary|
12040465|NCT00281619|Procedure|Blood Sampling|
12040466|NCT00281606|Drug|Different formulations of once-daily lopinavir/ritonavir|CCTG585 is a randomized, open-label, two arm cross-over study to compare the tolerability of once daily LPV/r liquid versus capsules
12040467|NCT00281593|Drug|Telmisartan|
12040468|NCT00281593|Drug|Ramipril|
12040469|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for two weeks
12040470|NCT00281580|Drug|Placebo|Placebo to Telmisartan and Amlodipine once daily for eight weeks
12040471|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
12040472|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
12040476|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
12040477|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
12040478|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for two weeks
12040479|NCT00281580|Drug|Amlodipine 5 mg|amlodipine 5g once daily for eight weeks
12040480|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
12040481|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for eight weeks
12040482|NCT00281580|Drug|Amlodipine 5 mg|amlodipine 5mg once daily for eight weeks
12040483|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
12040484|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
12040485|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
12040486|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
12040487|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
12040488|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
12040489|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for two weeks
12040490|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
12040491|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
12040492|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
12040493|NCT00281580|Drug|Amlodipine 5 mg|amlodipine 5g once daily for two weeks
12040494|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for eight weeks
12040495|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
12040496|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
12040497|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
12040498|NCT00281567|Drug|Tiotropium|
12040499|NCT00281567|Device|Respimat SMI|
12040500|NCT00281567|Device|HandiHaler|
12040501|NCT00281554|Drug|RSD1235|IV
12040502|NCT00281541|Drug|YM155|
12040503|NCT00281528|Drug|ABI-007 (Abraxane)|30 minute infusions
12040504|NCT00281528|Drug|bevacizumab|infusions
12040505|NCT00281515|Drug|Lonafarnib|100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
12040506|NCT00281502|Drug|Rifaximin (drug)|Rifaximin 400mg three (3) times daily
12040507|NCT00281489|Device|BIS Monitor guided algorithm|BIS guided algorithm (BIS target 40 to 60) during anesthesia. Alarms when BIS is outside this range.
12040508|NCT00281489|Behavioral|Volatile anesthetic guided algorithm|Volatile anesthetic guided algorithm. Target anesthetic concentration 0.7 to 1.3 minimum alveolar concentration during anesthesia. Alarms when anesthetic concentration not in this range.
12040509|NCT00281476|Drug|Simvastatine|
12040510|NCT00281463|Device|Pushrim Activated Power Assist|The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation).
12040511|NCT00281450|Behavioral|Educational intervention|We developed a set of explicit criteria for pharmacological inappropriateness for Norwegian GPs' prescribing to elderly patients. The main purpose of the criteria was to serve as quality indicators during an educational intervention: the Prescription Peer Academic Detailing (Rx-PAD) Study, aimed at improving GPs' prescribing for elderly patients.
12040512|NCT00281437|Behavioral|choice of exercise program|
12040513|NCT00281424|Device|pedometer|gave pedometer and info
12040514|NCT00281411|Procedure|Computed Tomography Angiography|Computed Tomography Angiography
12040515|NCT00281411|Procedure|Magnetic Resonance Angiography|Magnetic Resonance Angiography
12040516|NCT00281398|Behavioral|Questionnaire|
12040517|NCT00281385|Behavioral|traditional vs. lifestyle exercise|
12040518|NCT00281359|Device|With heat|heat pad followed by dynamic splinting
12040519|NCT00281359|Device|No heat|No heat added to tissue prior to dynamic splinting
12040520|NCT00281346|Procedure|Doppler echocardiography|Echocardiography
12040521|NCT00281333|Behavioral|"Karate exercises and strengthening exercises"|
12040522|NCT00281320|Drug|Asenapine|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).
12040523|NCT00281307|Drug|RRR-alpha-tocopherol 1,000 IU/mL|Intranasal application three times daily vs. placebo (inert excipient)
12040524|NCT00281294|Drug|Fontolizumab|
12040525|NCT00281281|Drug|vancomycin|
12040526|NCT00281268|Procedure|pulmonary artery catheter|
12040527|NCT00281268|Procedure|central venous catheter|
12040528|NCT00281268|Procedure|fluid management|
12040529|NCT00281255|Drug|Allopurinol|
12040530|NCT00281255|Drug|Dobutamine|
12040531|NCT00281242|Other|blood draw|All subjects undergo blood draws at study visits and at the time of COPD exacerbation visits.
12040532|NCT00281203|Procedure|blood drawing|blood will be drawn on the entry visit and will starting the intravenous (IV) line on the day of bronchoscopy
12040533|NCT00281203|Procedure|fiberoptic bronchoscopy|A flexible instrument will be passed through the mouth and into the lungs. Portions of the lungs will be washed, by injecting and immediately suctioning out a small amount of fluid. The entire return will be used for research purposes, and no results will be reported to the participant. Bronchoscopy is performed once.
12040534|NCT00281190|Procedure|Blood drawing|blood will be drawn at the time of starting the intravenous (IV) line for the procedure.
12040535|NCT00281190|Procedure|Bronchoalveolar lavage during indicated bronchoscopy|A small amount of liquid will be introduced and immediately sucked back out of portions of the lung, and the cells that are recovered will be analyzed in the laboratory. All test will be solely for research, and there will be no results reported to the subject from that fluid.
12040537|NCT00281125|Drug|PTK787 and Pemetrexed with or without Cisplatin|
12040538|NCT00281099|Device|ICD (Implantable Cardioverter Defibrillator)|VVI 40 vs. MVP
12040539|NCT00281073|Device|Intra-Cardiac Echocardiography guided Cardioversion|Intracardiac Echo and TEE
12040540|NCT00281073|Device|Intracardiac Echo|Intracardiac Echo Viewmate
12040541|NCT00281073|Device|ICE|ICE or TEE
12040542|NCT00281060|Procedure|primary stenting|
12040543|NCT00281047|Drug|FP-10|
12040544|NCT00281021|Drug|Erlotinib plus Digoxin|Each subject will receive erlotinib and digoxin daily until progression.
12040545|NCT00281008|Drug|ISIS 301012 or Placebo|50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
12040546|NCT00281008|Drug|ISIS 301012 or Placebo|100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
12040547|NCT00281008|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
12040548|NCT00281008|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
12040549|NCT00280995|Drug|ISIS 301012|100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
12040550|NCT00280995|Drug|ISIS 301012|200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
12040551|NCT00280995|Drug|ISIS 301012|300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64,71, 78, and 85
12040552|NCT00280995|Drug|ISIS 301012|50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
12040553|NCT00280982|Biological|tumor lysate-loaded autologous dendritic cells|50x10e6 cells per vaccination, 3 times, 2 weeks interval
12040554|NCT00280969|Drug|atazanavir arm|Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
12040555|NCT00280969|Drug|efavirenz|Patients are treated with efavirenz 300mg along with Epzicom.
12040556|NCT00280956|Drug|natalizumab|
12040557|NCT00280943|Behavioral|Long-term care facilities in the intervention arm will receive education and feedback audit on performance|
12040558|NCT00280930|Drug|Letrozole|
12040559|NCT00280917|Drug|CF101|
12040560|NCT00280904|Device|Shunt catheter|standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.
12040561|NCT00280878|Drug|gemcitabine|
12040562|NCT00280878|Drug|vinorelbine|
12040563|NCT00280878|Drug|ifosfamide|
12040564|NCT00280878|Drug|rituximab|
12040565|NCT00280865|Drug|Tesaglitazar|
12040566|NCT00280865|Drug|Pioglitazone|
12040567|NCT00280865|Behavioral|Dietary and Lifestyle Modification Counseling|
12040568|NCT00280826|Drug|Efalizumab|Participants who qualified for the study received weekly subcutaneous treatments of efalizumab, with the first dose being a test dose of 0.7 mg/kg and subsequent doses of 1 mg/kg (not to exceed 200 mg per dose), for a total treatment duration of 16 weeks.
12040569|NCT00280813|Behavioral|Supportive Treatment in Addiction Recovery (STAR)|
12040570|NCT00280800|Device|constant CPAP devices|different CPAP mode
12040571|NCT00280800|Device|automatic CPAP devices|different CPAP mode
12040572|NCT00280787|Drug|Paclitaxel|175 mg/m2 administered on Day 1, of a 21 day cycle. Subjects will receive 2 cycles
12040573|NCT00280787|Drug|Carboplatin|Area Under the Curve(AUC)=5 administered on Day 1 of a 21 day cycle. Subjects will receive 2 cycles.
12040574|NCT00280787|Drug|CPT-11|100 mg/m2 administered on Day 1 of each 21 day cycle. Subjects will receive 2 cycles.
12040575|NCT00280787|Drug|Pegfilgrastim|6 mg administered on Day 2 each each 21 day cylce. Subjects will receive 2 cycles of treatment.
12040576|NCT00280787|Radiation|Conformal radiotherapy|Radiation therapy will be administered with standard daily fractionation of 2.0 Gy per fraction, 5 days per week.The total dose of radiotherapy will be 74 Gy
12040577|NCT00280774|Drug|Memantine|
12040578|NCT00280761|Drug|capecitabine|Capecitabine administration (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist
12040579|NCT00280761|Drug|5-fluorouracil|Administration of 5-fluorouracil (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing and dose modification will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist.
12040580|NCT00280761|Procedure|Surgical Resection|Surgery will occur approximately 2-6 weeks after chemoradiation depending on clinical factors (i.e. resectability, presence or absence of metastatic disease).
12040581|NCT00280761|Radiation|Radiation therapy|Dosing and dose modification will be per current standard of care at the discretion of the treating Radiation Oncologist.
12040582|NCT00280748|Drug|pemetrexed disodium|500 mg/m2 once every 21 days up to 126 days
12040583|NCT00280748|Radiation|radiation therapy|Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy
12040584|NCT00280735|Drug|carboplatin|Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
12040585|NCT00280735|Drug|docetaxel|75 mg/m² intravenously, once, every 3 weeks
12040586|NCT00280722|Behavioral|patient information leaflet|
12040587|NCT00280709|Device|"Nitinella ; SX-ELLA Stent Biliary (biliary metal stent)"|Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
12040588|NCT00280696|Drug|Levetiracetam 250 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 250 mg
~Route of Administration: Oral Use"
12040589|NCT00280696|Drug|Levetiracetam 500 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 500 mg
~Route of Administration: Oral Use"
12040590|NCT00280696|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Film-coated tablet
~Concentration: 250 mg and 500 mg
~Route of Administration: Oral Use"
12040591|NCT00280683|Drug|L-arginine|subjects will take matching 0.01 g/kg/day of L-arginine in divided doses for thre months.
12040637|NCT00280293|Drug|Lamotrigine|Lamotrigine
12040592|NCT00280683|Drug|Placebo|Placebo tablets that match the L-arginine intervention tablets will be given for three months
12040593|NCT00280670|Behavioral|Cognitive-behavioral therapy|Cognitive behavioral therapy for children with autism and anxiety.
12040594|NCT00280657|Drug|Valette|1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
12040595|NCT00280657|Drug|Diane|1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
12040596|NCT00280657|Drug|Placebo|2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
12040597|NCT00280644|Drug|Leflunomide|
12040598|NCT00280631|Drug|Ezatiostat Hydrochlorine|Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.
12040599|NCT00280618|Drug|Oxaliplatin|
12040600|NCT00280605|Drug|Alfuzosin|
12040601|NCT00280592|Drug|Cranberry|Dry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day (in the morning and in the evening).
12040602|NCT00280592|Drug|Placebo|Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).
12040603|NCT00280566|Drug|Placebo|Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.
12040604|NCT00280566|Drug|Ziprasidone Oral Capsule|Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.
12040605|NCT00280553|Drug|bupivicaine|PCA and bupivicaine infusion for up to five days
12040606|NCT00280553|Other|Saline infusion|PCA and pump with saline infusion for up to five days
12040607|NCT00280540|Drug|Valsartan/Hydrochlorothiazide|
12040608|NCT00280514|Drug|cefpirome and moxifloxacin administration|
12040609|NCT00280501|Drug|Quetiapine (drug)|Quetiapine (Seroquel 100mg-film-coated tablet, AstraZeneca Vienna, Austria) Dose: 100 mg tablet oral single dose
12040610|NCT00280501|Drug|Sulpiride (drug)|Sulpiride (Dogmatil 200mg-tablet, Synthélabo Groupe, Le Plessis Robinson, France) Dose: one half of 200 mg tablet oral single dose
12040611|NCT00280501|Drug|Placebo|Placebo
12040612|NCT00280488|Behavioral|Motivational Interview|Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
12040613|NCT00280488|Behavioral|Assessment|In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
12040614|NCT00280488|Behavioral|Motivational Interview|Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
12040615|NCT00280475|Device|Whole brain radiation therapy arm|Whole brain radiation therapy arm
12040616|NCT00280475|Device|Salvage stereotactic radiosurgery arm|Salvage stereotactic radiosurgery arm
12040617|NCT00280462|Drug|Nifedipine (drug)|Nifedipine (Adalat®, Bayer, Leverkusen, Germany) dose: 15µg/kg bolus infusion over 5 minutes; 0.2 µg/(kg.min) maintenance dose infusion period 25 minutes
12040618|NCT00280462|Drug|L-Arginin (drug)|L-Arginin (Clinalfa AG, Läufelfingen, Switzerland) 30% sodium chlorid solution, dose: 1g/min over 30 minutes
12040619|NCT00280462|Drug|Placebo|Placebo
12040620|NCT00280449|Behavioral|strengths-based case managed proactive service model|
12040621|NCT00280436|Drug|GW679769|
12040622|NCT00280423|Drug|GW679769|
12040623|NCT00280410|Drug|E7337|
12040624|NCT00280397|Drug|E7080|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
12040625|NCT00280384|Drug|E2014 (Botulinum toxin type B)|A single-dose injection solution containing 20 units (U), 100 U, or 500 U/ 0.2 milliliters (mL) of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.
12040626|NCT00280384|Drug|E2014 (Botulinum toxin type B) Placebo|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.
12040627|NCT00280371|Drug|Formoterol Fumarate|
12040628|NCT00280358|Drug|Fluticasone Propionate|
12040629|NCT00280358|Drug|Formoterol Fumarate|
12040630|NCT00280345|Procedure|Trabeculectomy|A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork
12040631|NCT00280345|Procedure|Trabeculectomy and cataract surgery|A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork and the removal of the cataract
12040632|NCT00280345|Procedure|Cataract surgery|Removal of the cataract from the eye
12040633|NCT00280332|Procedure|colonoscopy|proform a follow up colonoscopy in the 5 year period from index colonoscopy
12040634|NCT00280319|Behavioral|interpersonal psychotherapy for groups|psychotherapy
12040635|NCT00280319|Behavioral|creative play therapy|consisted of play activities
12040636|NCT00280306|Other|No interventions|No intervention
12040638|NCT00280293|Drug|Placebo|Placebo
12040639|NCT00280280|Drug|intramuscular Botox versus oral baclofen|Each vial of Botox contains 100 units of Clostridium botulinum toxin type A, 0.5 mg albumin (human) and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. Botox placebo is sterile normal saline (without preservatives) for injection. Baclofen is supplied as 10 mg tablets for oral administration. Inactive ingredients include colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch. Baclofen placebo tablets are composed of microcrystalline cellulose binder (99%), magnesium stearate 0.5%, and silica gel 0.5% and appear similar to commercial Baclofen tablets.
12040640|NCT00280267|Drug|Testosterone gel|
12040641|NCT00280254|Procedure|Hemodynamically Oriented Echocardiography-based Strategy|
12040642|NCT00280241|Drug|Fludarabine|Fludarabine is usually administered by IV infusion over 30 minutes or longer.
12040643|NCT00280241|Drug|Cyclophosphamide|The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
12040644|NCT00280241|Drug|Rituximab|First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
12040645|NCT00280228|Behavioral|Adolescent Skills Parent Management Parent-Adol Negotiation|Acute treatment for 12 weeks followed by three monthly booster sessions.
12040646|NCT00280228|Behavioral|Treatment as Usual|Standard outpatient treatment for behavioral problems and substance use
12040647|NCT00280215|Drug|ACEI / Angiotensin converting enzyme inhibitor|Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker, Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
12040648|NCT00280215|Drug|ARB /Angiotensin Receptor Blocker|Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker,Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
12040649|NCT00280215|Drug|Placebo|Patients will receive placebo for 24 months
12040650|NCT00280202|Procedure|Biopsy of the major carinal area|Biopsy performed intraoperatively
12040651|NCT00280202|Procedure|Biopsy of abnormal & suspicious areas of the bronchial tree|Biopsy performed intraoperatively
12040652|NCT00280202|Procedure|Evaluation of the tumor for DNA mutations|Tumor tissue is banked for future analysis.
12040653|NCT00280202|Procedure|Bronchoalveolar Lavage (BAL) for cytokine analysis|BAL performed intraoperatively
12040654|NCT00280202|Procedure|Correlation of flow cytometric & RT PCR for TNM stage|Tissues banked for future correlative studies
12040655|NCT00280202|Procedure|Analysis of lymph nodes|Tissues banked for future analysis
12040656|NCT00280189|Procedure|Radiofrequency ablation of pulmonary malignancies|Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
12040657|NCT00280189|Behavioral|Quality of life assessment|Quality of life assessment is administered prior to the Radiofrequency ablation procedure and every 3 months for 1 year following the procedure.
12040658|NCT00280189|Behavioral|Assessment of pain|Pain scores are obtained prior to the procedure, daily X 7 starting on the day of surgery, and then every 3 months for 1 year.
12040659|NCT00280176|Drug|bortezomib|0.7mg/m2 - 1.5mg.m2 given during Weeks 1, 2, 4 and 5 on a Monday/Thursday or Tuesday/Friday schedule, up to six weeks
12040660|NCT00280176|Drug|fluorouracil|225mg/m2 given weekly, up to 6 weeks
12040661|NCT00280176|Radiation|radiation therapy|180 cGy, every 5 days, up to six weeks
12040662|NCT00280150|Biological|bevacizumab|Given IV
12040663|NCT00280150|Drug|carboplatin|Given IV
12040664|NCT00280150|Drug|erlotinib hydrochloride|Given orally
12040665|NCT00280150|Drug|paclitaxel|Given IV
12040666|NCT00280150|Radiation|3-dimensional conformal radiation therapy|Given 5 days a week for 7 weeks
12040667|NCT00280111|Biological|116E AGMK|Single dose of 116E 10^5 FFu
12040668|NCT00280111|Drug|I321|Single dose of I321 10^5 FFu
12040669|NCT00280111|Drug|Placebo|1 crystal of potassium permanganate dissolved in the bicarbonate buffer to colour match the vaccine
12040670|NCT00280098|Drug|docetaxel|Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid
12040671|NCT00280085|Procedure|MR imaging|
12040672|NCT00280085|Procedure|Glucose clamp|
12040673|NCT00280085|Drug|Arginine|
12040674|NCT00280072|Device|Renal Assist Device|
12040675|NCT00280059|Drug|Pregabalin|dose 150-600 mg/day given BID
12040676|NCT00280059|Drug|Lamotrigine|dose 100-500 mg/day given BID
12040677|NCT00280046|Drug|biphasic insulin aspart|
12040678|NCT00280033|Biological|Aluminum hydroxide|Provided in vials that contain 0.8 mL volume per vial.
12040679|NCT00280033|Biological|Inactivated Influenza A/H5N1 Vaccine (Chiron)|Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg.
12040680|NCT00280033|Biological|MF-59|Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial.
12040681|NCT00280033|Drug|Placebo|Saline placebo.
12040682|NCT00280020|Behavioral|Tai Chi Chih (TCC)|Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
12040683|NCT00280020|Behavioral|Cognitive Behavior Therapy (CBT)|For each 2-hour session held once a week for 16 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.
12040684|NCT00280020|Behavioral|Sleep Seminar (SS)|Each 2-hour session, held once a week for 16 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion.
12040685|NCT00280007|Drug|bevacizumab|bevacizumab 5 mg/kg i.v. every 14 days for 52 weeks
12040686|NCT00279994|Procedure|Exercise therapy|
12040687|NCT00279994|Device|Accelerometer (PAM; Personal Activity Monitor)|
12040688|NCT00279994|Procedure|Oral Exercise Therapy advise|
12040689|NCT00279981|Device|Diagnostic|
12040690|NCT00279968|Device|ICD|
12040691|NCT00279955|Device|Cardiac Resynchronization Therapy Device|Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.
12040692|NCT00279942|Dietary Supplement|Soy|Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
12040693|NCT00279942|Other|Placebo|Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
12040694|NCT00279929|Procedure|DHEA Replacement|
12040695|NCT00279916|Drug|Triamcinolone acetonide nasal spray|"Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms).
~Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms)."
12040696|NCT00279916|Drug|Placebo nasal spray|"Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily.
~Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily."
12040697|NCT00279903|Drug|Botulinum toxin type A (Btx-A)|Participants randomized to Btx-A will be given either a low dose of 100 units or a high dose of 200 units. The Btx-A dose (100U or 200U) will be resonstituted with 4 cc of sterile non-preserved 0.9% sodium chloride solution.
12040698|NCT00279903|Drug|Cortisone|1 cc of 40 mg/cc methylprednisolone will be drawn up in 22 gauge needles with 3 cc of sterile non-preserved 0.9% sodium chloride solution.
12040699|NCT00279890|Drug|Topical SR-01|
12040700|NCT00279877|Procedure|Kyphoplasty|kyphoplasty
12040701|NCT00279838|Procedure|Computer Assisted Navigation Knee Replacement|
12040702|NCT00279825|Drug|IPX054 200 mg|IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
12040703|NCT00279825|Drug|IPX054 250 mg|IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
12040704|NCT00279825|Drug|CD-LD IR|Active comparator containing 25 mg carbidopa and 100 mg levodopa
12040705|NCT00279825|Drug|CD-LD CR|Active comparator containing 50 mg carbidopa and 200 mg levodopa
12040706|NCT00279825|Drug|IPX054 200 mg Placebo|Placebo to match IPX054 200 mg
12040707|NCT00279825|Drug|IPX054 250 mg Placebo|Placebo to match IPX054 250 mg
12040708|NCT00279825|Drug|CD-LD IR Placebo|Placebo to match CD-LD IR
12040709|NCT00279825|Drug|CD-LD CR Placebo|Placebo to match CD-LD CR
12040710|NCT00279812|Dietary Supplement|50ug selenium enriched yeast|Selenomethionine supplement (50ug/d Se) for 12 weeks
12040711|NCT00279812|Dietary Supplement|100ug selenium enriched yeast|Selenomethionine supplement (100ug/d Se) for 12 weeks
12040712|NCT00279812|Dietary Supplement|200ug selenium enriched yeast|Selenomethionine supplement (200ug/d Se) for 12 weeks
12040713|NCT00279812|Dietary Supplement|Control onion|3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
12040714|NCT00279812|Dietary Supplement|Enriched onion|3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
12040715|NCT00279812|Other|Placebo|Placebo supplement for 12 weeks
12040716|NCT00279799|Behavioral|Afiya HIV Prevention Intervention|Group-based session plus individually tailored HIV prevention phone sessions
12040717|NCT00279799|Behavioral|Afiya HIV prevention intervention|Afiya group-based intervention + nutrition phone sessions (attention control)
12040718|NCT00279786|Procedure|Blood draw|blood drawn
12040719|NCT00279773|Drug|TKI258|
12040720|NCT00279760|Drug|Belatacept|
12040721|NCT00279760|Drug|Abatacept|
12040722|NCT00279747|Drug|meloxicam 0.25 mg/kg|
12040723|NCT00279747|Drug|meloxicam 0.125 mg/kg|
12040724|NCT00279747|Drug|naproxen 10 mg/kg|
12040725|NCT00279734|Drug|Tetanus + pnemococcal vaccines alone|0 mg + vaccines, Single dose, 28 days.
12040726|NCT00279734|Drug|Abatacept + vaccines|Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
12040727|NCT00279734|Drug|Abatacept + vaccines|Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
12040728|NCT00279734|Drug|Abatacept + Vaccines|parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
12040729|NCT00279721|Procedure|IMRT|
12040730|NCT00279708|Drug|Atorvastatin|Placebo vs. Atorvastatin
12040731|NCT00279708|Other|Placebo Oral Tablet|Placebo: Sham Therapy in an oral tablet formulation
12040732|NCT00279695|Procedure|high frequency ultrasound examination|high frequency ultrasound examination of the eye
12040733|NCT00279682|Behavioral|treatment guidelines and depression care management|
12040734|NCT00279669|Procedure|Ultrasound examination|contact ultrasound examination
12040735|NCT00279656|Behavioral|Pharmaceutical care|
12040736|NCT00279643|Procedure|Laser Hair Removal|
12040737|NCT00279630|Procedure|Orthoses and Exercise|orthrose and exercise - daily
12040738|NCT00279617|Drug|levetiracetam|open label levetricetam
12040739|NCT00279604|Behavioral|'Problem Profile Intervention' vs. WHO-Brief Intervention|
12040740|NCT00279591|Device|Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device|Continuous blood pressure monitoring of patients during med flight to hospital
12040741|NCT00279591|Device|Standard of care blood pressure monitoring|Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.
12040742|NCT00279578|Drug|ReFacto (Recombinant factor VIII) and Tranexamic acid|
12040743|NCT00279565|Drug|buprenorphine|
12040744|NCT00279565|Drug|methadone|
12040745|NCT00279565|Drug|pegylated interferon alfa-2b plus ribavirin|
12040746|NCT00279552|Drug|Recombinant human intrinsic factor|
12040747|NCT00279539|Genetic|Vascular Endothelial Growth Factor (VEGF1)|
12040748|NCT00279513|Drug|Traumeel S|
12040749|NCT00279500|Device|Argus 16 Retinal Stimulation System|The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
12040750|NCT00279487|Drug|Gabapentin|
12040751|NCT00279487|Drug|Placebos|
12040752|NCT00279474|Behavioral|cognitive-behavior groups|
12040753|NCT00279461|Drug|Placebo in arm A and Vitamin D in arm B|Vitamin D3 at 2,000 units daily, all in one capsule, for 6 months and Placebo provided in matching capsule, one capsule daily, for 6 months
12040754|NCT00279461|Drug|vitamin D 3 for arm A ,and matching placebo for arm B|Arm A 2,000 units of Vitamin D3 in one capsule daily for 6 months. Arm B matching placebo capsule, one daily for 6 months
12040755|NCT00279448|Drug|exemestane|On tablet of 25 mg per day during 5 years
12040756|NCT00279448|Drug|tamoxifen|Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment
12040757|NCT00279435|Drug|visilizumab|
12040758|NCT00279422|Drug|visilizumab|
12040759|NCT00279422|Drug|visilizumab|
12040760|NCT00279409|Drug|aripiprazole|double blind capsules (abilify or placebo) taken once daily, up to 10mg.
12040761|NCT00279409|Drug|Sugar pill|double blind capsules (abilify or placebo) taken once daily, up to 10mg.
12040762|NCT00279383|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
12040763|NCT00279357|Procedure|Narrow Band Imaging|
12040764|NCT00279344|Drug|Fentanyl (Matrifen)|
12040765|NCT00279305|Drug|Anti-CD20 (rituximab)|
12040766|NCT00279305|Drug|Placebo Comparator|Placebo intravenous infusion
12040767|NCT00279292|Procedure|Celiac Plexus Neurolysis|
12040768|NCT00279279|Device|Implanted Device|
12040769|NCT00279266|Drug|Thiamine|
12040770|NCT00279253|Drug|clonidine (drug) intravenously|
12040771|NCT00279240|Drug|Metformin|
12040772|NCT00279214|Drug|drotrecogin alfa (activated)|
12040773|NCT00279201|Drug|Insulin glargine|Subcutaneous injection daily
12040774|NCT00279201|Drug|Lispro Low Mix|Subcutaneous injection twice daily.
12040775|NCT00279201|Drug|Lispro Mid Mix|Lispro Mid Mix subcutaneous injection 3 times daily.
12040776|NCT00279201|Drug|Lispro|Lispro subcutaneous injection 3 times daily.
12040777|NCT00279188|Procedure|Guiding therapy by bronchial hyperrsponsiveness|
12040778|NCT00279175|Biological|Intracoronary infusion of enriched bone marrow-derived progenitor cells|
12040779|NCT00279175|Biological|Placebo medium supplemented with autologous serum|
12040780|NCT00279162|Drug|Calcipotriene/betamethasone gel and ointment|
12040781|NCT00279149|Procedure|Visio conference system connected to the Tele-stroke network|Visio conference system connected to the Tele-stroke network
12040782|NCT00279123|Drug|pantoprazole infusion|
12040783|NCT00279123|Drug|pantoprazole bolus|
12040784|NCT00279123|Drug|no treatment|
12040785|NCT00279110|Behavioral|Directly administered antiretroviral therapy (DAART)|Participants are observed taking HIV medications on days when they receive opioid agonist therapy.
12040786|NCT00279097|Device|High Frequency Chest Wall Oscillation|
12040787|NCT00279084|Drug|GROUP A: if necessary, martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 110 to 129 g/L.|
12040788|NCT00279084|Drug|GROUP B: martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 130 to 149 g/L|
12040789|NCT00279071|Device|Acupuncture og acupressure when diagnosed with dystocia|Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67
12040790|NCT00279058|Procedure|Immunotherapy treatment for melanoma|
12040791|NCT00279045|Drug|Rosiglitazone|
12040792|NCT00279045|Drug|glyburide|
12040793|NCT00279045|Drug|metformin|
12040794|NCT00279032|Drug|GW406381|
12040795|NCT00279019|Drug|GSK233705|GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
12040796|NCT00279019|Drug|Tiotropium|Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
12040797|NCT00279019|Drug|Placebo|Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
12040798|NCT00279006|Procedure|Percutaneous coronary intervention|
12040799|NCT00278993|Drug|E7389|Intravenous 1.4 mg/m2 on a 3-week course.
12040800|NCT00278980|Drug|C-peptide|
12040801|NCT00278967|Drug|HalfLytely with Bisacodyl Tablets Bowel Prep Kit|
12040802|NCT00278967|Drug|HalfLytely - Reformulation|
12040803|NCT00278954|Biological|Gammaplex (Intravenous immunoglobulin)|GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously for 12 months.
12040804|NCT00278941|Drug|Quetiapine Fumarate Sustained Release|
12040805|NCT00278928|Drug|Liposyn III 20% (lipid infusion)|
12040806|NCT00278928|Drug|Intralipid 20% (lipid infusion)|
12040807|NCT00278915|Drug|Fulvestrant|intramuscular injection
12040808|NCT00278902|Drug|ARRY-334543, EGFR/ErbB2 inhibitor; oral|Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule
12040809|NCT00278889|Drug|AZD2171|oral tablet
12040810|NCT00278889|Drug|5-fluorouracil|intravenous infusion
12040811|NCT00278889|Drug|Leucovorin|intravenous infusion
12040812|NCT00278889|Drug|Oxaliplatin|intravenous infusion
12040813|NCT00278889|Drug|Bevacizumab|intravenous infusion
12040814|NCT00278876|Drug|Imatinib mesylate (Glivec)|Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
12040815|NCT00278863|Drug|S-1|
12040816|NCT00278863|Drug|Capecitabine|
12040817|NCT00278850|Behavioral|Educational|three 1 hour long educational seminars
12040818|NCT00278837|Behavioral|Mindfulness based meditation program|Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.
12040819|NCT00278824|Drug|Matrix Transdermal Fentanyl/CHADD Drug Delivery System|Patch applied every 3 days for 15 days
12040820|NCT00278824|Drug|Placebo Patch|Placebo patch applied every 3 days for 15 days
12040821|NCT00278811|Procedure|mobile crisis team|
12040822|NCT00278785|Behavioral|Brief Motivational Interview|10-20 minute brief motivational interview
12040823|NCT00278772|Drug|Divalproex|oral, 15mg/kg/day - 30mg/kg/day
12040824|NCT00278772|Other|Placebo|oral dose, placebo
12040825|NCT00278759|Procedure|Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.|See Detailed Description.
12040826|NCT00278746|Drug|Zinc and ORS|Government and private providers and village health workers were trained to prescribe zinc and ORS for use in diarrheal episodes in 1 month to 5 years old children in intervention communities
12040827|NCT00278746|Drug|ORS only|Promoted routine management of diarrhea in underfive with ORS
12040828|NCT00278733|Behavioral|Brief intervention (physician advice)|
12040829|NCT00278707|Drug|GTA: Glyceryltriacetate|
12040830|NCT00278694|Drug|Oxaliplatin|
12040831|NCT00278694|Drug|Chemoradiation|
12040832|NCT00278694|Drug|5-FU|
12040833|NCT00278694|Radiation|Preoperative chemoradiation|
12040834|NCT00278694|Procedure|Pelvic surgery|
12040835|NCT00278694|Drug|Neoadjuvant oxaliplatin|
12040836|NCT00278681|Drug|Zinc and ORS|"One strip containing 14 dispersible zinc tablets (20 mg each) along with 2 ORS packets were prescribed to all children aged 1 month to 5 years visiting that channel with diarrhea.
~Infants aged less than 6 months were advised half a zinc tablet in a teaspoonful of breast milk; older children were advised 1 tablet in breast milk or clean water."
12040837|NCT00278655|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
12040838|NCT00278642|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
12040839|NCT00278629|Biological|hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
12040840|NCT00278616|Biological|Stem Cell Transplantation|Autologous Stem Cell Transplantation
12040841|NCT00278603|Biological|Stem Cell Transplantation|Autologous Hematopoietic Stem Cell Injection
12040842|NCT00278590|Biological|Allogeneic Stem Cell Transplantation|Allogeneic stem cell transplantation will be performed.
12040843|NCT00278577|Biological|Immune Ablation and Hematopoietic Stem Cell Support|Autologous Hematopoietic Stem Cell Transplant
12040844|NCT00278564|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
12040845|NCT00278564|Drug|Cyclophosphamide|
12040846|NCT00278564|Drug|Mesna|
12040847|NCT00278564|Drug|ATG(rabbit)|
12040848|NCT00278564|Drug|Methylprednisolone|
12040849|NCT00278564|Drug|G-CSF|
12040850|NCT00278564|Drug|Rituxan|
12040851|NCT00278551|Biological|Immune ablation and hematopoietic stem cell transplant|Autologous Hematopoietic Stem Cell Transplant
12040852|NCT00278538|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
12040853|NCT00278525|Drug|standard of care|standard of care medication will be given
12040854|NCT00278525|Procedure|stem cell transplantation|The following is intervention: stem cell transplantation after conditioning regimen
12040855|NCT00278512|Biological|Autologous Stem Cell Transplant|Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning
12040856|NCT00278512|Biological|Allogeneic Stem Cell Transplant|Allogeneic Stem Cell Transplant will be performed after conditioning
12040857|NCT00278512|Drug|Cyclophosphamide|Causes prevention of the cell division
12040858|NCT00278512|Drug|ATG (rabbit)|A rabbit polyclonal antibody to lymphocyte
12040859|NCT00278512|Drug|G-CSF|Hematopoietic growth factor
12040860|NCT00278512|Drug|Campath-1h|Humanized monoclonal antibody against CD52 antigen
12040861|NCT00278512|Drug|Fludarabine|inhibits DNA synthesis or repair
12040862|NCT00278512|Drug|Tacrolimus|immune suppressive drug
12040863|NCT00278512|Drug|Mesna|Mesna is a drug used to protect the bladder from the effects of the chemotherapy drugs
12040864|NCT00278499|Behavioral|Cross-sectional surveys|Cross-sectional surveys will occur at study entry, Month 6, and Month 12. Every fourth participant enrolled in the FSW cross-sectional survey, all FSWs found to be HIV infected, and all FSWs who are intravenous drug users will participate in a substudy lasting 12 months.
12040865|NCT00278499|Behavioral|Questionnaire/counseling|An initial questionnaire and counseling will occur once in addition to post-test counseling.
12040866|NCT00278486|Biological|Hematopoietic stem cell transplantation.|Autologous hematopoietic stem cell transplantation will be performed.
12040867|NCT00278473|Behavioral|Meta-Cognitive Therapy|Cognitive Behavioral Group Treatment
12040868|NCT00278473|Behavioral|Supportive Therapy|Social Support Problem-Solving Group Treatment
12040869|NCT00278460|Drug|docetaxel|40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days
12040870|NCT00278460|Drug|gemcitabine hydrochloride|800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.
12040871|NCT00278447|Behavioral|Chronic Disease Management for substance abuse|Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
12040872|NCT00278447|Behavioral|Standard care|Referral to primary medical care for persons with substance dependence.
12040873|NCT00278434|Drug|Zoledronate|
12040874|NCT00278434|Other|Placebo (Saline)|
12040875|NCT00278421|Biological|rituximab|
12040876|NCT00278421|Drug|cyclophosphamide|
12040877|NCT00278421|Drug|doxorubicin hydrochloride|
12040878|NCT00278421|Drug|prednisone|
12040879|NCT00278421|Drug|vincristine sulfate|
12040880|NCT00278408|Biological|filgrastim|
12040881|NCT00278408|Biological|rituximab|
12040882|NCT00278408|Drug|cyclophosphamide|
12040883|NCT00278408|Drug|doxorubicin hydrochloride|
12040884|NCT00278408|Drug|prednisone|
12040885|NCT00278408|Drug|vincristine sulfate|
12040886|NCT00278408|Radiation|radiation therapy|
12040887|NCT00278395|Drug|Vorinostat|Given orally
12040888|NCT00278382|Drug|sorafenib tosylate|Given orally
12040889|NCT00278382|Other|laboratory biomarker analysis|Correlative studies
12041022|NCT00277238|Drug|CPG10101|CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
12041023|NCT00277225|Drug|Abatacept|
12040890|NCT00278369|Biological|aldesleukin|The IL-2 is given as a 15-minute infusion through an intravenous catheter (I.V.), a small plastic tube that is put into your vein for the time you are receiving the study treatment. IL-2 is given through the I.V. once every 8 hours for 5 days (days 1-5). A second 5 day cycle of IL-2 will begin on the 15th day (days 15-19). This is one complete cycle (days 1-19) of IL-2 treatment
12040891|NCT00278369|Biological|denileukin diftitox|Denileukin diftitox will be administered once daily as a 15 to 60 minute infusion for 3 consecutive days.
12040892|NCT00278343|Drug|cediranib maleate|30mg given PO, daily
12040893|NCT00278343|Other|laboratory biomarker analysis|Correlative studies
12040894|NCT00278330|Drug|alvocidib|Given by infusion
12040895|NCT00278330|Drug|vorinostat|Given orally
12040896|NCT00278304|Radiation|brachytherapy|
12040897|NCT00278304|Radiation|radiation therapy|
12040898|NCT00278278|Drug|cisplatin|Given IV
12040899|NCT00278278|Drug|etoposide|Given IV
12040900|NCT00278278|Drug|ifosfamide|Given IV
12040901|NCT00278278|Drug|lomustine|Given IV
12040902|NCT00278278|Drug|methotrexate|Given IV
12040903|NCT00278278|Drug|prednisone|Given IV
12040904|NCT00278278|Drug|vincristine sulfate|Given IV
12040905|NCT00278265|Drug|MTX followed by fludarabine|MTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administered with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles
12040906|NCT00278252|Drug|etoposide|
12040907|NCT00278252|Procedure|conventional surgery|
12040908|NCT00278239|Procedure|cognitive assessment|
12040909|NCT00278239|Procedure|psychosocial assessment and care|
12040910|NCT00278239|Procedure|quality-of-life assessment|
12040911|NCT00278226|Behavioral|smoking cessation intervention|
12040912|NCT00278226|Other|educational intervention|
12040913|NCT00278213|Biological|alemtuzumab|
12040914|NCT00278213|Drug|cyclophosphamide|
12040915|NCT00278213|Drug|fludarabine phosphate|
12040916|NCT00278213|Drug|mitoxantrone hydrochloride|
12040917|NCT00278200|Biological|Inactivated EBV-infected vaccine|
12040918|NCT00278187|Biological|volociximab|
12040919|NCT00278187|Drug|erlotinib hydrochloride|
12040920|NCT00278174|Biological|recombinant interferon alpha-1b|
12040921|NCT00278161|Biological|Pegfilgrastim|6 mg SQ 24-48 hours after last dose of cyclophosphamide.
12040922|NCT00278161|Biological|Rituximab|375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.
12040923|NCT00278161|Drug|Cyclophosphamide|50 mg/kg/day on Days 15, 16, 17, and 18.
12040924|NCT00278148|Drug|carboplatin|AUC2 weekly x 3 weeks
12040925|NCT00278148|Drug|Erlotinib|Daily
12040926|NCT00278148|Drug|paclitaxel|50mg/m2/weekly x 3 weeks
12040927|NCT00278148|Procedure|conventional surgery|conventional surgery
12040928|NCT00278148|Radiation|radiation therapy|150 cGy bid
12040929|NCT00278135|Dietary Supplement|DHA (nutritional supplement) or placebo|oral 900mg/day
12040930|NCT00278122|Biological|sargramostim|
12040931|NCT00278122|Drug|paclitaxel|
12040932|NCT00278109|Drug|cyclophosphamide|chemotherapy
12040933|NCT00278109|Drug|Doxorubicin|doxorubicin
12040934|NCT00278109|Radiation|radiation|radiation
12040935|NCT00278096|Behavioral|occupational therapy|
12040936|NCT00278083|Drug|Study drug administration|
12040937|NCT00278083|Procedure|Tuberculin intradermal skin test|
12040938|NCT00278083|Procedure|Lung function test for FEV1|
12040939|NCT00278083|Procedure|Asthma symptom scores diary|
12040940|NCT00278083|Procedure|Quality of life diary|
12040941|NCT00278083|Procedure|Breath nitric oxide|
12040942|NCT00278083|Procedure|Breath condensate|
12040943|NCT00278083|Procedure|Sputum induction|
12040944|NCT00278083|Procedure|Blood sampling|
12040945|NCT00278083|Procedure|Urinalysis|
12040946|NCT00278070|Drug|vinorelbine oral formulation|Patients will take three times a week [Monday, Wednesday and Friday] by mouth, a standard dose of soft capsules of vinorelbine given at dose ascribed by randomization procedure
12040947|NCT00278057|Drug|dialysisis with and without glucose in the dialysis|
12040948|NCT00278044|Procedure|blood sampling and medical records|
12040949|NCT00278018|Procedure|Immunotherapy treatment for solid tumors|
12040950|NCT00277914|Drug|Flibanserin|flibanserin flexible dosing
12040951|NCT00277888|Procedure|Femoral route for hemodialysis|
12040952|NCT00277888|Procedure|Jugular route for hemodialysis|
12040953|NCT00277875|Drug|ALT-711 (alagebrium chloride)|
12040954|NCT00277862|Drug|Pegylated IFN- alpha 2b|
12040955|NCT00277862|Drug|Ribavirin|
12040956|NCT00277836|Drug|MST-997|
12040957|NCT00277823|Drug|DVS-SR 50 mg|
12040958|NCT00277823|Drug|DVS-SR 100 mg|
12040959|NCT00277823|Drug|Placebo|
12040960|NCT00277810|Drug|lecozotan SR (SRA-333)|one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr
12040961|NCT00277797|Device|Biowave Targeted Non-Invasive Electronic Pain Control Device|"This device is a non-invasive non-pharmacologic treatment for pain. It sends a premixed modulated envelope of two high frequency electronic wave forms (Feed Signals) between two electrodes."
12040962|NCT00277797|Device|TENS (Transcutaneous Electrical Nerve Stimulation) device|This device features a bisourced, biphasic waveform. The combined constant voltage, constant-current waveform provides a strong stimulus that allows the clinician to prescribe a treatment program.
12040963|NCT00277784|Procedure|Ultrasound examination|one ultrasound examination
12040964|NCT00277771|Behavioral|Standard behavioral treatment (SBT) for weight loss|Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Standard paper diaries are used for self-monitoring.
12041024|NCT00277212|Drug|Lamotrigine + Aripiprazole|"Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks
~Lamotrigine 100-200 mg/day
~Aripiprazole 10-30 mg/day"
12040965|NCT00277771|Behavioral|SBT for weight loss using a PDA|Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants (PDAs) are used for self-monitoring.
12040966|NCT00277771|Behavioral|SBT for weight loss using a PDA with feedback messages|Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants with a customized feedback program are used for self-monitoring.
12040967|NCT00277758|Biological|Interleukin 2|Interleukin-2 at 1.2 mU/M2 administered subcutaneously daily
12040968|NCT00277758|Drug|Ribavirin|Ribavirin @ 800 mg daily (< 65 kg body weight), 1000 mg (65-85 kg), and 1200 mg (> 85 kg)
12040969|NCT00277758|Biological|Pegylated Interferon Alpha|Pegylated-Interferon-alpha 1.5 ug/kg weekly subcutaneously.
12040970|NCT00277758|Biological|Inteleukin-2|Interleukin-2 administered as a daily subcutaneous injection at 1.2 mU/M2 BSA
12040971|NCT00277758|Drug|Ribavirin + Pegylated interferon-alpha|Pegylated interferon-alpha administered 1.5 ug/kg weekly. Ribivirin 800 mg daily for body weight <65 kg, 1000 mg for body weight 65-85 kg, and 1200 mg for body weight >85 kg.
12040972|NCT00277745|Device|miniaturized microfluidic system|Subjects will provide appropriate periodontal treatment as needed.
12040973|NCT00277732|Procedure|Pharmaceutical care at baseline and follow-up visits over 6 months|
12040974|NCT00277706|Procedure|Periodontal surgery|
12040975|NCT00277706|Drug|FORTEO|parathyroid hormone; self-administration for 6 weeks
12040976|NCT00277706|Drug|Placebo|placebo; self administration for 6 weeks
12040977|NCT00277706|Dietary Supplement|Vitamin D and Calcium|PO, QD, for six weeks
12040978|NCT00277693|Drug|Spironolactone (drug)|
12040979|NCT00277680|Procedure|Laparoscopic bilateral occlusion of uterine artery|
12040980|NCT00277680|Procedure|Radiological embolization (UFE)|
12040981|NCT00277667|Drug|Quetiapine|Oral dosing: 50mg (Day 1), 100mg (Day 2), 150mg (Day 3), 200mg (Day 4), followed by flexible dosing from 50mg to 800mg through day 56.
12040982|NCT00277654|Drug|Risperidone|risperidone 0.5mg up to 4mg daily vs. placebo
12040983|NCT00277641|Drug|Lamotrigine|25 mg or 100 mg
12040984|NCT00277641|Drug|placebo|identical tablets to study drug
12040985|NCT00277602|Drug|Riluzole|
12040986|NCT00277589|Drug|Levothyroxin-Na|1 tablet 30 minutes before breakfast
12040987|NCT00277589|Drug|Levothyroxine-Na + iodide|1 tablet 30 minutes before breakfast
12040988|NCT00277589|Drug|Iodide|1 tablet 30 minutes before breakfast
12040989|NCT00277589|Drug|Placebo|1 tablet 30 minutes before breakfast
12040990|NCT00277576|Biological|ppdpSC18 administered by PMED|
12040991|NCT00277563|Device|reduction of pain scores by magnetic energy|
12040992|NCT00277550|Drug|Tegaserod and Placebo|
12040993|NCT00277537|Drug|Mannitol|320mg BD 12 weeks followed by 40 weeks open label
12040994|NCT00277537|Drug|placebo|BD for 12 weeks
12040995|NCT00277511|Drug|Levofloxacin|
12040996|NCT00277498|Drug|Xalacom|
12040997|NCT00277498|Drug|Xalatan|
12040998|NCT00277498|Drug|Timolol|
12040999|NCT00277472|Drug|Valsartan/Hydrochlorothiazide|160/12.5 mg taken once daily orally
12041000|NCT00277472|Drug|HCTZ|25 mg taken once daily orally
12041001|NCT00277446|Drug|Soy isoflavones|
12041002|NCT00277433|Other|Buccal Swab|collection of buccal swab
12041003|NCT00277420|Behavioral|Comprehensive weight management|
12041004|NCT00277407|Procedure|NAET with acupressure and/or chiropractic procedures|
12041005|NCT00277394|Drug|innohep®|175 anti-Xa IU/kg administered subcutaneously (SC) once daily
12041006|NCT00277394|Drug|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
12041007|NCT00277381|Behavioral|Automated feedback regarding drug adherence|
12041008|NCT00277368|Other|A structured questionnaire for seizure-related headache|A structured questionnaire for seizure-related headache
12041009|NCT00277355|Drug|minocycline|Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (~ 8 hours apart)
12041010|NCT00277355|Drug|Matching placebo|Matching placebo 1 capsule twice daily, 18 months treatment duration.
12041011|NCT00277342|Procedure|measurement of lipid-induced hepatic insulin resistance|
12041012|NCT00277329|Drug|XL999|• The Study Treatment Period, in which subjects received a once-weekly, 4-hour intravenous (IV) infusion of XL999 at 2.4 mg/kg as outpatients for 8 weeks. Treatment was to be stopped at the occurrence of disease progression or unacceptable toxicity.
12041013|NCT00277316|Drug|XL999|Treatment was administered on an outpatient basis. XL999 was administered at a dose of 2.4 mg/kg given as a 4 hour IV infusion.
12041014|NCT00277303|Drug|XL999|XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience.
12041015|NCT00277290|Drug|XL999|Treatment was administered on an outpatient basis. XL999 was administered at 2.4 mg/kg as a 4 hour intravenous (IV) infusion. Subjects received a XL999 infusion once a week for 8 weeks of treatment unless drug-related toxicity required a dosing delay
12041016|NCT00277277|Behavioral|Healthium|
12041017|NCT00277264|Drug|Tiotropium (Spiriva®)|
12041018|NCT00277251|Drug|Alendronate|
12041019|NCT00277238|Drug|CPG10101|CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
12041020|NCT00277238|Drug|CPG10101|CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
12041021|NCT00277238|Drug|Control|Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 12wks
12041081|NCT00276757|Drug|methotrexate|
12041025|NCT00277212|Drug|Lamotrigine + Placebo|"Tablets, Oral, once daily, Phase 2 - up to 52 weeks
~Lamotrigine 100-200 mg/day
~placebo 0 mg/day"
12041026|NCT00277199|Drug|Abatacept|
12041027|NCT00277186|Other|New Care Continuum|Patient experience surgery through newly designed arthroplasty continuum
12041028|NCT00277173|Behavioral|Adoption of Crew Resource Management approach|
12041029|NCT00277160|Drug|Neulasta (pegfilgrastim)|Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
12041030|NCT00277147|Drug|BB IND 6989|
12041031|NCT00277108|Drug|Escitalopram (Lexapro)|
12041032|NCT00277095|Device|ProACT (Adjustable Continence Therapy)|Implantable device to reduce urinary stress incontinence
12041033|NCT00277082|Drug|9-NC in aerosol reservoir|Samples will be minced or centrifuged and L9NC extracted by chromatography. L9NC will be measured by HPLC or mass spectrometry
12041034|NCT00277069|Drug|Carboplatin|Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days
12041035|NCT00277069|Device|Capecitabine|Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days
12041036|NCT00277069|Drug|Vinorelbine|Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days
12041037|NCT00277043|Drug|paclitaxel, docetaxel, taxane|1 mg paclitaxel or docetaxel test dose is prepared in 3 ml of normal saline and administered over two to five minutes IV push at least 30 minutes after prescribed IV and PO pre-medications. If no discernable adverse reaction ensues, the balance of the taxane dose is prepared and administered as per standard or specific chemotherapy protocol.
12041038|NCT00277043|Drug|taxane|The full taxane dose is prepared and administered as per standard or specific chemotherapy protocol, at least 30 minutes after prescribed IV and PO pre-medications.
12041039|NCT00277030|Drug|Surfactant|
12041040|NCT00277030|Device|Nasal CPAP|
12041041|NCT00277017|Drug|5-Flourouracil, Interferon-a, IL-2 and Thalidomide|"Patients will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a max of 1200mg/day. This will be taken in combination with:5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks.
~Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks. Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks.
~Treatment will be followed by 2 weeks of rest then repeated."
12041042|NCT00276991|Drug|"Kallunk oxide (Immunotherapy) "|"The study was assigned only one Arm >450 cu/mm^3 of baseline CD + T cells. HIV type-1 subjects were received one drug, a daily regimen of Kallunk oxide(Immunotherapy) + Long Pepper, that is a combination of a traditional alternative medicine(Complementary and Alternative Medicine CAM) as Kallunk oxide and appropriate drug carrier antidote. The drug assigns to 0.100 mg and 0.200 mg Kallunk oxide molecules with 199.900 mg, and 499.800 mg Antidote( This antidote was used as a carrier of Kallunk oxide molecules), respectively, for children and adults. Dosage: 200 mg for children and 500 mg for adults. This powder form sample size product was administered once daily dose on 5 days treatment. The Botanical name of the antidote is Piper Longum."
12041043|NCT00276978|Drug|Aripiprazole|Addition of Aripiprazole 10 mg to concurrent medication
12041044|NCT00276965|Drug|Sertraline|Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
12041045|NCT00276965|Drug|Lithium carbonate|Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
12041046|NCT00276952|Drug|Gonyautoxin|
12041047|NCT00276939|Behavioral|Low-fat, low-Glycemic Index, vegan diet|
12041048|NCT00276926|Drug|STI571|
12041049|NCT00276913|Drug|STA-5312|
12041050|NCT00276900|Drug|Sertraline|
12041051|NCT00276887|Behavioral|Cognitive Behavior Therapy|
12041052|NCT00276887|Behavioral|Psychiatric Consultation Letter|
12041053|NCT00276874|Drug|Aripiprazole|Aripiprazole; 0-30 mg; oral; daily
12041054|NCT00276874|Drug|Placebos|Placebo; 0 mg; oral; daily
12041055|NCT00276861|Drug|gemcitabine hydrochloride|
12041056|NCT00276861|Drug|oxaliplatin|
12041057|NCT00276848|Drug|Fludarabine plus Cyclophosphamide|fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses
12041058|NCT00276848|Drug|Fludarabine|fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses
12041059|NCT00276835|Biological|High-dose interleukin-2|Administered days 1-5, and 15-19; the patient will receive 600,000 IU/kg IL-2 by intravenous infusion over 15 minutes every 8 hours (on day 1 and day 15, patients will receive a maximum of 2 doses per day; on all other days in the cycle patients will receive a maximum of 3 doses per day)
12041060|NCT00276835|Dietary Supplement|genistein|Starting on day 10 and continuing through day 19, genistein will be administered orally at a dose of 600mg/day in two divided doses (i.e. 300mg po bid x 10 days)
12041061|NCT00276822|Other|communication intervention|Patient Education Programs to include surveys, questionnaires, interviews, and videos.
12041062|NCT00276809|Biological|alemtuzumab|
12041063|NCT00276809|Biological|filgrastim|
12041064|NCT00276809|Drug|carmustine|
12041065|NCT00276809|Drug|cyclophosphamide|
12041066|NCT00276809|Drug|cytarabine|
12041067|NCT00276809|Drug|dexamethasone|
12041068|NCT00276809|Drug|etoposide|
12041069|NCT00276809|Drug|fludarabine phosphate|
12041070|NCT00276809|Drug|melphalan|
12041071|NCT00276809|Procedure|autologous bone marrow transplantation|
12041072|NCT00276809|Procedure|peripheral blood stem cell transplantation|
12041073|NCT00276809|Radiation|radiation therapy|
12041074|NCT00276796|Drug|cisplatin|
12041075|NCT00276796|Drug|paclitaxel|
12041076|NCT00276796|Drug|topotecan hydrochloride|
12041077|NCT00276783|Drug|pemetrexed|Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
12041078|NCT00276770|Other|fluorine F 18 fluorothymidine|
12041079|NCT00276770|Procedure|positron emission tomography|
12041080|NCT00276757|Drug|leucovorin calcium|
12041083|NCT00276757|Drug|vinblastine sulfate|
12041084|NCT00276744|Biological|cetuximab|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041085|NCT00276744|Drug|capecitabine|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041086|NCT00276744|Drug|docetaxel|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041087|NCT00276744|Drug|Erlotinib|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041088|NCT00276744|Drug|Gemcitabine|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041089|NCT00276744|Drug|Irinotecan|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041090|NCT00276744|Drug|mitomycin C|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041091|NCT00276744|Drug|rapamycin|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041092|NCT00276744|Procedure|conventional surgery|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
12041093|NCT00276731|Drug|carboplatin|
12041094|NCT00276731|Drug|cisplatin|
12041095|NCT00276731|Drug|cyclophosphamide|
12041096|NCT00276731|Drug|etoposide|
12041097|NCT00276731|Drug|vincristine sulfate|
12041098|NCT00276731|Procedure|conventional surgery|
12041099|NCT00276731|Procedure|neoadjuvant therapy|
12041100|NCT00276731|Radiation|radiation therapy|
12041101|NCT00276718|Biological|bleomycin sulfate|
12041102|NCT00276718|Drug|carboplatin|
12041103|NCT00276718|Drug|etoposide|
12041104|NCT00276718|Procedure|conventional surgery|
12041105|NCT00276705|Drug|cisplatin|
12041106|NCT00276705|Drug|cyclophosphamide|
12041107|NCT00276705|Drug|doxorubicin hydrochloride|
12041108|NCT00276705|Drug|thalidomide|
12041109|NCT00276705|Procedure|adjuvant therapy|
12041110|NCT00276705|Procedure|conventional surgery|
12041111|NCT00276705|Procedure|neoadjuvant therapy|
12041112|NCT00276692|Drug|irinotecan hydrochloride|
12041113|NCT00276679|Drug|temozolomide|
12041114|NCT00276666|Drug|cisplatin|
12041115|NCT00276666|Drug|lomustine|
12041116|NCT00276666|Drug|vincristine sulfate|
12041117|NCT00276666|Procedure|adjuvant therapy|
12041118|NCT00276666|Radiation|radiation therapy|
12041119|NCT00276640|Drug|vincristine, carboplatin|"vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21
~carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21"
12041120|NCT00276640|Drug|vincristine, carboplatin, etoposide|"vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21
~carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21
~etoposide: 100 mg/m² i.v., week 1,4,7,10"
12041121|NCT00276640|Radiation|radiation therapy|"intracranial tumor site: 30 fractions, dose per fraction: 1.8 Gy, total dose: 54 Gy, duration 6 weeks
~spinal tumor site: 28 fractions, dose per fraction: 1.8 Gy, total dose: 50.4 Gy duration 5 1/2 weeks"
12041122|NCT00276627|Behavioral|communication lecture|lecture on communication skills with oncology patients
12041123|NCT00276627|Behavioral|lecture plus CD-ROM|Interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.
12041124|NCT00276614|Drug|bortezomib|
12041125|NCT00276601|Drug|arsenic trioxide|
12041126|NCT00276601|Drug|cytarabine|
12041127|NCT00276601|Drug|daunorubicin hydrochloride|
12041128|NCT00276601|Drug|mercaptopurine|
12041129|NCT00276601|Drug|methotrexate|
12041130|NCT00276601|Drug|tretinoin|
12041131|NCT00276588|Drug|carboplatin|
12041132|NCT00276588|Drug|gemcitabine hydrochloride|
12041133|NCT00276588|Drug|paclitaxel|
12041134|NCT00276575|Biological|bevacizumab|
12041135|NCT00276575|Drug|erlotinib hydrochloride|
12041136|NCT00276575|Drug|everolimus|
12041137|NCT00276549|Drug|docetaxel|docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
12041138|NCT00276549|Drug|gemcitabine hydrochloride|IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
12041139|NCT00276536|Biological|recombinant interferon alpha-1b|interferon
12041140|NCT00276536|Drug|IFN|IFN daily
12041141|NCT00276523|Biological|PEG-interferon alfa-2b|Study medication begins on Day 1 and taken subcutaneously once each week with the last dose being taken within 1 week prior to surgery or biopsy.
12041246|NCT00275509|Drug|Cytogam|Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
12041142|NCT00276523|Procedure|Conventional surgery|Participants on the control arm may undergo surgery at anytime within 3 weeks of randomization, and those randomized to PEG-Intron will undergo surgery on Days 16-22 following initiation of treatment.
12041143|NCT00276523|Procedure|Neoadjuvant therapy|
12041144|NCT00276510|Drug|EGb 761® (Tanakan®)|120 mg, 1 tablet twice a day, oral route, during 5 years.
12041145|NCT00276510|Other|Placebo|1 tablet twice a day, oral route, during 5 years.
12041146|NCT00276497|Drug|Pioglitazone|
12041147|NCT00276484|Drug|atorvastatin|Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
12041148|NCT00276484|Drug|atorvastatin|Atorvastatin 40 mg by mouth, once a day for 6 weeks
12041149|NCT00276484|Drug|ezetimibe|Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.
12041150|NCT00276471|Device|Implantable pulse generator and electrodes|
12041151|NCT00276458|Drug|Comparator: atorvastatin|Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
12041152|NCT00276458|Drug|Comparator: Placebo|Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
12041153|NCT00276458|Drug|Comparator: ezetimibe|Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
12041154|NCT00276458|Drug|Comparator: Placebo.|Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.
12041155|NCT00276445|Drug|beta-1,3-glucan|
12041156|NCT00276432|Device|iSTAT point of care analyzer|
12041157|NCT00276419|Drug|Diclofenac|Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
12041158|NCT00276419|Drug|Placebo|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
12041159|NCT00276406|Drug|Pyridostigmine|Pyridostigmine will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.
12041160|NCT00276406|Drug|Placebo|If subject is randomized to placebo, placebo pills will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.
12041161|NCT00276393|Drug|Basal insulin|
12041162|NCT00276380|Drug|EGb761|EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.
12041163|NCT00276380|Drug|Placebo|Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.
12041164|NCT00276380|Drug|Acetylsalicylic acid|Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
12041165|NCT00276354|Drug|PEG 4000 (Forlax ®)|
12041166|NCT00276341|Drug|EGb 761® (Tanakan®)|
12041167|NCT00276328|Drug|Diosmectite (Smecta®)|
12041168|NCT00276315|Biological|Botulinum toxin type A|
12041169|NCT00276302|Drug|IPI-504|"IV administration of IPI-504 for 21-day cycles. Two different schedules of treatment will be tested. On Schedule A, doses occur on Days 1, 4, 8, and 11 followed by 10 days with no study drug administration. On Schedule B, doses occur on Days 1, 4, 8, 11, 15, and 18, or twice weekly for 3 weeks continuously.
~For both Schedule A and B doses will be administered ≥ 72 hours apart."
12041170|NCT00276289|Drug|Spironolactone|
12041171|NCT00276276|Drug|topotecan|
12041172|NCT00276263|Drug|Sarcosine (N-methylglycine)|Randomization to two treatment groups. One group treated with sarcosine 2 g/day for 16 weeks, the other group treated with placebo 2 g/day for 16 weeks.
12041173|NCT00276250|Drug|Efalizumab|Efalizumab was a medication approved for use in psoriasis which was being explored to determine efficacy with immunosuppression following organ transplantation. Efalizumab was administered subcutaneously on a weekly basis. Upon efalizumab being withdrawn from the US market, the protocol was amended to alter the immunosuppressive regimen to abatacept for the study participants.
12041174|NCT00276250|Drug|Abatacept|Abatacept is drug used to treat autoimmune diseases. Abatacept is administered intravenously, monthly, in weight-based doses and is given for as long as transplanted islets are functioning.
12041175|NCT00276250|Drug|Belatacept|Belatacept is a medication to provide extended graft survival while limiting the toxicity generated by standard immune suppressing regimens. Belatacept is administered intravenously. The protocol for this study was amended to substitute belatacept for abatacept for all newly enrolling participants (current participants remained on abatacept).
12041176|NCT00276224|Drug|ferrous sulphate (drug)|
12041177|NCT00276198|Dietary Supplement|Sprinkles|Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.
12041178|NCT00276198|Dietary Supplement|Ferripel-3, Vitamins A&D drops|Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months
12041179|NCT00276185|Drug|Time delay treatment of botulinum toxin|
12041180|NCT00276172|Drug|Natalizumab|Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
12041181|NCT00276159|Drug|852A|Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
12041182|NCT00276146|Drug|oral dipyridamole, oral magnesium, or a combination of both|
12041183|NCT00276133|Drug|Effects of atorvastatin versus probucol on small dense LDL|
12041184|NCT00276107|Biological|Prevenar|
12041185|NCT00276094|Drug|Ospemifene 30 mg|1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
12041186|NCT00276094|Drug|Ospemifene 60 mg|1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
12041187|NCT00276094|Drug|Placebo|1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
12041188|NCT00276094|Drug|Nonhormonal vaginal lubricant|Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
12041189|NCT00276081|Drug|Gabapentin, Estrogen and placebo administration|
12041190|NCT00276068|Drug|topical lidocaine + oral desipramine, and/or placebo|
12041241|NCT00275509|Other|Plasmapheresis|Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
12041242|NCT00275509|Drug|Mycophenolate mofetil|2 gm/day. Standard of care
12041243|NCT00275509|Drug|Tacrolimus|To achieve serum level of 8-10 ng/ml.
12041244|NCT00275509|Drug|Dexamethasone|100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses
12041245|NCT00275509|Drug|Prednisone|Taper over three months to 5 mg daily
12041191|NCT00276055|Drug|Gemcitabine, Docetaxel and Bevacizumab|During the treatment phase, pts. will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks. This 4-week period is called a cycle of treatment. The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period. Pts. will then receive bevacizumab IV over a 30-minute period. Pts. will receive this treatment once every 2 weeks. Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects. As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
12041192|NCT00276042|Drug|Faropenem Medoxomil|
12041193|NCT00276029|Drug|Etanercept|
12041194|NCT00276016|Drug|phenylephrine|immediate-release 12 mg capsules for oral administration
12041195|NCT00276016|Drug|pseudoephedrine|60 mg immediate-release tablets for oral administration
12041196|NCT00276016|Drug|placebo|placebo capsules
12041197|NCT00276003|Drug|Gemcitabine, Irinotecan, Allopurinol.|Gemcitabine - 1000mg/m2; IV; d1, 8; q 21 days Irinotecan - 100mg/m2; IV; d1, 8; q 21 days Allopurinol - 300 mg; PO; day 1-5; 1st cycle
12041198|NCT00275990|Device|rheolytic thrombectomy with direct stenting|
12041199|NCT00275990|Device|direct stenting|
12041200|NCT00275977|Procedure|Coronary catherization and stem cell infusion|
12041201|NCT00275964|Drug|TMN-1|
12041202|NCT00275951|Drug|Cetuximab Plus P-HDFL|Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.
12041203|NCT00275938|Drug|interferon alpha 2b plus ribavirin|
12041204|NCT00275938|Drug|interferon alpha 2b plus placebo|
12041205|NCT00275925|Drug|Oxcarbazepine|
12041206|NCT00275912|Drug|Oxcarbazepine|
12041207|NCT00275834|Drug|Zonisamide|zonisamide 400 mg, 200 mg, or placebo
12041208|NCT00275821|Drug|Ranibizumab 0.3 mg - 3 times monthly, then quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
12041209|NCT00275821|Drug|Ranibizumab 0.5 mg - 3 times monthly, then quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
12041210|NCT00275821|Drug|Ranibizumab 0.3 mg monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
12041211|NCT00275795|Procedure|NAET Procedures|
12041212|NCT00275769|Device|Pacemaker|
12041213|NCT00275756|Drug|Timolol (drug)|Timolol (0.5%, non-selective beta-blocker, Timoptic®, Merck Sharp & Dohme, Haarlem, Netherlands), dose 1 drop in one eye twice daily for two weeks
12041214|NCT00275756|Drug|dorzolamide (drug)|Dorzolamide (2%, carbonic anhydrase inhibitor, Trusopt®, Laboratoires Merck Sharp & Dohme - Chibret, France), dose: 1 drop in one eye twice daily for two weeks
12041215|NCT00275756|Drug|brimonidine (drug)|Brimonidine (0.2%. alpha-2 adrenergic agonist, Alphagan®, Allergan Pharmaceuticals, Westport, Ireland), dose: 1 drop in one eye twice daily for two weeks
12041216|NCT00275756|Device|Laser Doppler flowmetry|blood flow measurements at the temporal neuroretinal rim of the optic nerve head, in total 4x 9 minutes on 2 study days
12041217|NCT00275756|Device|Goldmann applanation tonometer|intraocular pressure measurements, in total 2x 5 measurements on two study days
12041218|NCT00275756|Procedure|Suction cup method|The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus; 4x 8 minutes on 2 study days
12041219|NCT00275743|Procedure|MRI|
12041220|NCT00275730|Drug|indometacine (drug) effect on ocular blood flow|
12041221|NCT00275704|Drug|Flaxseed|
12041222|NCT00275678|Procedure|Blood stem cell versus bone marrow transplant|"Cyclophosphamide and Total Body Irradiation (CY-TBI)-based regimens that include at least 120 mg/kg cyclophosphamide and at least 1200 cGy of fractionated TBI.
~Busulfan and cyclophosphamide (BU-CY)-based regimens that include at least 14 mg/kg busulfan orally or 11.2 mg/kg busulfan intravenously (14 x 0.8 correction factor) or a targeted busulfan dosing strategy aimed at a serum concentration greater than 600 ng/mL at steady state and at least 120 mg/kg cyclophosphamide.
~Fludarabine and melphalan (Flu-Mel)-based regimens that include a fludarabine dose of least 120 mg per m2 and a melphalan dose of at least 140 mg per m2.
~Fludarabine, busulfan, and ATG (Flu-Bu-ATG)-based regimens that include a fludarabine dose of at least 120 mg/m2, at least 8 mg/kg busulfan orally or 250 mg/m2 busulfan intravenously, and at least 40 mg/kg equine ATG or 4 mg/kg rabbit ATG. Institutional standards should be followed for targeting plasma levels."
12041223|NCT00275665|Drug|Valganciclovir|
12041224|NCT00275652|Drug|LdT (Telbivudine) and lamivudine|
12041225|NCT00275639|Drug|Cozaar|
12041226|NCT00275613|Drug|Rituximab|The Rituximab dose is 1000 mg (1 gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15)
12041227|NCT00275600|Drug|Vitamin E, Evening Oil of Primrose, and Placebo|
12041228|NCT00275574|Procedure|acupuncture|acupuncture
12041229|NCT00275561|Drug|Fluticasone|Aerosolized swallowed fluticasone 880 mg twice a day
12041230|NCT00275561|Drug|Placebo|Placebo inhaler swallowed twice a day for 6 weeks
12041231|NCT00275548|Drug|Pegasys|135-180 micrograms administered sc once weekly
12041232|NCT00275548|Drug|Copegus|400-1200 mg/day for 48 weeks
12041233|NCT00275535|Drug|Anti-thymocyte globulin|Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
12041234|NCT00275535|Drug|Mycophenolate mofetil|Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
12041235|NCT00275535|Drug|Prednisone|Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
12041236|NCT00275535|Drug|Tacrolimus|Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
12041237|NCT00275535|Drug|Sirolimus|Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
12041247|NCT00275496|Procedure|Sentinel Lymph Node Dissection|Subject has wide excision and sentinel lymph node dissection for primary melanoma.
12041248|NCT00275496|Procedure|Complete Lymph Node Dissection|Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.
12041249|NCT00275496|Procedure|Wide Excision|Subject has wide excision only for primary melanoma.
12041250|NCT00275483|Device|Vital-band (R)|
12041251|NCT00275457|Drug|pramipexole|
12041252|NCT00275444|Drug|Tipranavir|
12041253|NCT00275431|Drug|AT-101|Oral
12041254|NCT00275418|Drug|beta carotene from Dunaliella algae|
12041255|NCT00275405|Drug|Garlic Oil Macerate|
12041256|NCT00275392|Behavioral|Vestibular rehabilitation|vestibular adaptation and substitution exercises
12041257|NCT00275392|Behavioral|Placebo|placebo vestibular exercises
12041258|NCT00275379|Drug|ERB-041|
12041259|NCT00275366|Device|Robotic Therapy|
12041260|NCT00275353|Behavioral|Individualized Symptom Education|
12041261|NCT00275340|Other|Peer Support|
12041262|NCT00275314|Drug|Valganciclovir|
12041263|NCT00275301|Drug|olanzapine|Olanzapine 2.5mg by mouth at bedtime x2 weeks, then Olanzapine 5mg by mouth at bedtime x2 weeks, then Olanzapine 7.5mg by mouth at bedtime x4 weeks.
12041264|NCT00275275|Drug|Requip PR|Requip 24-Hour once a day for one month
12041265|NCT00275275|Drug|Mirapex|All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.
12041266|NCT00275262|Drug|Leuprolide acetate depot (LAD) 11.25 mg 3 Month|LAD intramuscular injection 11.25 mg, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.
12041267|NCT00275262|Drug|Matched placebo|Matched placebo intramuscular injection, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.
12041268|NCT00275249|Drug|levorphanol|
12041269|NCT00275236|Drug|Rotigotine|
12041270|NCT00275210|Drug|Oxaliplatin (SR96669)|
12041271|NCT00275197|Drug|Sertraline and Elzasonan Combination|
12041272|NCT00275197|Drug|Sertraline|
12041273|NCT00275197|Drug|Placebo|
12041274|NCT00275184|Drug|Senna|
12041275|NCT00275184|Drug|Citramag powder|
12041276|NCT00275184|Drug|Metoclopramide|
12041277|NCT00275171|Drug|Recombinant human thyrotropin (Thyrogen)|0.1 mg rhTSH administered intramuscularly
12041278|NCT00275171|Drug|recombinant human TSH|0.1 mg rhTSH administered intramuscularly
12041279|NCT00275171|Other|isotonic saline = placebo|0.1 mg isotonic saline injected intramuscularly
12041280|NCT00275158|Drug|L-Arginine Supplementation|
12041281|NCT00275145|Behavioral|Resistance Training|Lifting weights 3 times per week; 8 different exercise each time; for each exercise, do three sets = lifting an appropriate weight between 8-12 for each set; rest 45 seconds (at least) between sets
12041282|NCT00275145|Behavioral|Aerobic Exercise|Exercise at 75% of maximal capacity for approximately 2 hours per week
12041283|NCT00275145|Behavioral|Combo|Lift weights (as described in RT group) and do aerobic exercise (as described in Aerobic group
12041284|NCT00275145|Behavioral|Continued Sedentary lifestyle|No changes
12041285|NCT00275132|Drug|erlotinib hydrochloride|Tarceva (OSI-774, erlotinib) PO 150 mg daily
12041286|NCT00275132|Drug|Matched placebo|Matched placebo PO daily
12041287|NCT00275119|Drug|fluorouracil|
12041288|NCT00275119|Drug|gemcitabine hydrochloride|
12041289|NCT00275119|Drug|oxaliplatin|
12041290|NCT00275119|Radiation|radiation therapy|
12041291|NCT00275106|Drug|asparaginase|
12041292|NCT00275106|Drug|cyclophosphamide|
12041293|NCT00275106|Drug|cytarabine|
12041294|NCT00275106|Drug|daunorubicin hydrochloride|
12041295|NCT00275106|Drug|dexamethasone|
12041296|NCT00275106|Drug|doxorubicin hydrochloride|
12041297|NCT00275106|Drug|leucovorin calcium|
12041298|NCT00275106|Drug|mercaptopurine|
12041299|NCT00275106|Drug|methotrexate|
12041300|NCT00275106|Drug|prednisolone|
12041301|NCT00275106|Drug|thioguanine|
12041302|NCT00275106|Drug|vincristine sulfate|
12041303|NCT00275106|Procedure|radiation therapy|
12041304|NCT00275093|Drug|temsirolimus|Given IV
12041305|NCT00275093|Other|laboratory biomarker analysis|Correlative studies
12041306|NCT00275093|Other|pharmacological study|Correlative studies
12041307|NCT00275080|Drug|vorinostat|Given orally
12041308|NCT00275080|Drug|decitabine|Given IV
12041309|NCT00275067|Drug|arsenic trioxide|Arsenic trioxide administered intravenously at a dose of 0.20mg/kg Daily x 5 week then twice per week
12041310|NCT00275067|Drug|temozolomide|Temozolomide administered orally once per day 1 hour prior to radiation therapy at a dose of 75 mg/m2 x 42 days; at a dose of 200mg/m2 for 5 days every cycle (1 cycle = 28 days) after radiation therapy
12041311|NCT00275067|Radiation|radiation therapy|All patients will receive 5940-6120 cGy of radiation therapy as 28-33 treatments/fractions (180-200 cGy/treatment) depending on whether they receive standard 3-D conformal radiation therapy or intensity modulated radiation therapy.
12041312|NCT00275054|Drug|Fludarabine|cycles 1-6: 25 mg/m² i.v., d2-4, q28d
12041313|NCT00275054|Drug|Cyclophosphamide|cycles 1-6: 250 mg/m² i.v., d2-4, q28d
12041314|NCT00275054|Biological|Rituximab|"cycle1: 375 mg/m² i.v., d1, q28d
~cycles 2-6: 500 mg/m² i.v., d1, q28d"
12041315|NCT00275041|Biological|cetuximab|
12041316|NCT00275041|Drug|irinotecan hydrochloride|
12041317|NCT00275028|Drug|cediranib maleate|Given orally
12041318|NCT00275015|Biological|filgrastim|
12041319|NCT00275015|Drug|carmustine|
12041320|NCT00275015|Drug|cyclophosphamide|
12041321|NCT00275015|Drug|cytarabine|
12041322|NCT00275015|Drug|dexamethasone|
12041323|NCT00275015|Drug|etoposide|
12041324|NCT00275015|Drug|fludarabine phosphate|
12041325|NCT00275015|Drug|melphalan|
12041326|NCT00275015|Procedure|bone marrow ablation with stem cell support|
12041327|NCT00275015|Procedure|peripheral blood stem cell transplantation|
12041328|NCT00275015|Radiation|radiation therapy|
12041329|NCT00275002|Drug|O6-benzylguanine|Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. O6-Benzylguanine, 120 mg/m^2, will be administered as a one-hour intravenous (IV) infusion, daily for 5 days. Four consecutive weeks will constitute one course. Courses will be repeated every 4 weeks for up to 12 courses of therapy.
12041330|NCT00275002|Drug|temozolomide|Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Temozolomide, 75 mg/m^2 (rounded to the nearest 5 mg, the size of the smallest capsule) will be given orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course. Courses will be repeated every 4 weeks for up to 12 courses.
12041331|NCT00274989|Drug|Bendamustine|"First-Line Therapy: Bendamustine i.v. 90 mg/m² day 1-2, q4wks, cycle 1 to 6
~2nd to 4th -Line Therapy: Bendamustine i.v. 70 mg/m² day 1-2 q4wks, cycle 1 to 6"
12041332|NCT00274989|Biological|Rituximab|"First-Line Therapy: Rituximab i.v. 375 mg/m² day 0, q4wks, cycle 1; Rituximab i.v. 500 mg/m² day 1, q4wks, cycle 2-6
~2nd to 4th -Line Therapy: Rituximab i.v. 375 mg/m² day 0, q4wks, cycle 1; Rituximab i.v. 500 mg/m² day 1, q4wks, cycle 2-6"
12041333|NCT00274976|Biological|alemtuzumab|
12041334|NCT00274963|Drug|bendamustine hydrochloride|
12041335|NCT00274963|Drug|mitoxantrone hydrochloride|
12041336|NCT00274950|Biological|bleomycin sulfate|
12041337|NCT00274950|Drug|carboplatin|
12041338|NCT00274950|Drug|cisplatin|
12041339|NCT00274950|Drug|etoposide|
12041340|NCT00274950|Drug|ifosfamide|
12041341|NCT00274950|Drug|vinblastine sulfate|
12041342|NCT00274950|Procedure|adjuvant therapy|
12041343|NCT00274950|Procedure|conventional surgery|
12041344|NCT00274937|Drug|amifostine trihydrate|Given subcutaneously
12041345|NCT00274937|Drug|fluorouracil|Given IV
12041346|NCT00274937|Drug|cisplatin|Given IV
12041347|NCT00274937|Other|laboratory biomarker analysis|Correlative studies
12041348|NCT00274937|Radiation|radiation therapy|Undergo radiotherapy
12041349|NCT00274924|Biological|filgrastim|Given subcutaneously or intravenous bolus.
12041350|NCT00274924|Biological|rituximab|Given IV
12041351|NCT00274924|Drug|carboplatin|Given IV
12041352|NCT00274924|Drug|cyclophosphamide|Given IV
12041353|NCT00274924|Drug|doxorubicin hydrochloride|Given IV
12041354|NCT00274924|Drug|etoposide|Given IV
12041355|NCT00274924|Drug|ifosfamide|Given IV
12041356|NCT00274924|Drug|prednisone|Taken orally
12041357|NCT00274924|Drug|vincristine|Given IV
12041358|NCT00274911|Drug|cisplatin|
12041359|NCT00274911|Drug|lomustine|
12041360|NCT00274911|Drug|vincristine sulfate|
12041361|NCT00274911|Procedure|adjuvant therapy|
12041362|NCT00274911|Radiation|radiation therapy|
12041363|NCT00274898|Drug|celecoxib|
12041364|NCT00274898|Drug|docetaxel|
12041365|NCT00274898|Procedure|adjuvant therapy|
12041366|NCT00274898|Radiation|radiation therapy|
12041367|NCT00274885|Drug|oxaliplatin|
12041368|NCT00274885|Procedure|management of therapy complications|
12041369|NCT00274872|Drug|fluorouracil|
12041370|NCT00274872|Drug|leucovorin calcium|
12041371|NCT00274872|Drug|oxaliplatin|
12041372|NCT00274859|Drug|gemcitabine hydrochloride|
12041373|NCT00274859|Drug|oxaliplatin|
12041374|NCT00274846|Biological|aldesleukin|10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses
12041375|NCT00274846|Biological|therapeutic allogeneic lymphocytes|Cells infused per kg. 1.5-8.0 x 10^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10^9
12041376|NCT00274846|Drug|cyclophosphamide|Days -5 and -4: 60 mg/kg
12041377|NCT00274846|Drug|fludarabine phosphate|Days -5 through -2: 25 mg/m^2
12041378|NCT00274846|Procedure|in vitro treated peripheral blood stem cell transplantation|Day 0 infuse natural killer cells
12041379|NCT00274833|Drug|erlotinib hydrochloride|Erlotinib is available as 25 mg, 100 mg, and 150 mg tablets. It should be administered orally once daily at the prescribed dose specified in the clinical study protocol per dose escalation schema. Preferably, erlotinib should be taken in the morning with up to 200 mL of water at least 1 hour before or 2 hours after a meal.
12041380|NCT00274833|Drug|temozolomide|TMZ is supplied in white opaque, preservative-free, two piece hard gelatin capsules of the following sizes: 100mg capsules, 20mg capsules, and 5mg capsules. TMZ will be a once a day orally administered (75 mg/m2 x BSA x 42 days)set of capsules taken at least two hours after and one hour before a meal.
12041381|NCT00274833|Radiation|radiation therapy|Concomitant focal RT will be delivered once daily at 2 Gy per fraction, 5 d/wk, for a total of 60 Gy. (6 weeks) as mentioned in therapeutic modalities.
12041382|NCT00274820|Dietary Supplement|ascorbic acid|The dose of ascorbic acid will be 1000 mg PO 2-3 hours prior to ATO infusion. The treatment will follow the same schedule as arsenic trioxide.
12041383|NCT00274820|Drug|arsenic trioxide|Treatment consists of a loading period of five 0.25 mg/kg ATO doses in the first week, followed by maintenance dosing with 0.25 mg/kg ATO twice weekly for 11 weeks. Loading is usually done Monday through Friday of the first treatment week. Maintenance should be started either 72 or 96 hours after the last loading dose. Thereafter, dosing is twice weekly, following an alternating pattern of 72 and 96 hours. For example, maintenance dosing may be done on Mondays and Thursdays, Tuesdays and Fridays, etc. The same pattern should be followed for the entire maintenance dosing period.
12041384|NCT00274820|Drug|dexamethasone|Dexamethasone will be given at a dose of 4mg PO daily for five days every four weeks (i.e., days 1-5, 29-33, 57-61, 84-88, etc.).
12041385|NCT00274820|Drug|thalidomide|The dose of thalidomide will be 50 mg PO daily starting day 1. The dose will be increased to 100mg PO daily after two weeks if tolerated and only if patients experience < grade 1 thalidomide-attributed toxicity using CTC criteria.
12041386|NCT00274807|Biological|filgrastim|
12041387|NCT00274807|Drug|cytarabine|
12041388|NCT00274807|Drug|etoposide|
12041389|NCT00274807|Drug|mitoxantrone hydrochloride|
12041390|NCT00274794|Biological|filgrastim|10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide
12041391|NCT00274794|Biological|rituximab|375 mg/m2, IV, Once per week for 3 weeks.
12041392|NCT00274781|Drug|arsenic trioxide|Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).
12041393|NCT00274781|Drug|gemtuzumab ozogamicin|Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion
12041394|NCT00274768|Drug|capecitabine|A total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16).
12041395|NCT00274755|Drug|chemotherapy|
12041396|NCT00274755|Procedure|conventional surgery|
12041397|NCT00274755|Procedure|magnetic resonance imaging|
12041398|NCT00274755|Procedure|magnetic resonance spectroscopic imaging|
12041399|NCT00274755|Radiation|radiation therapy|
12041400|NCT00274742|Biological|Blinatumomab (MT103)|Doses from 0.5 to 120 µg/m^2/24hours by continuous intravenous infusion
12041401|NCT00274729|Behavioral|Mono Unsaturated Fatty Acids in Obesity|
12041402|NCT00274716|Drug|MK0736|
12041403|NCT00274716|Drug|MK0916|
12041404|NCT00274716|Drug|Placebo|
12041405|NCT00274703|Drug|mepolizumab|
12041406|NCT00274690|Drug|GW679769|
12041407|NCT00274677|Drug|Placebo|Experimental treatment arm
12041408|NCT00274677|Drug|lamotrigine|Experimental treatment
12041409|NCT00274664|Device|6 hours occlusion by patching|
12041410|NCT00274664|Device|12 hours occlusion by patching|
12041411|NCT00274651|Drug|belinostat|
12041412|NCT00274638|Drug|Telmisartan & Hydrochlorothiazide|
12041413|NCT00274638|Drug|Losartan & Hydrochlorothiazide|
12041414|NCT00274638|Procedure|ABPM|
12041415|NCT00274625|Device|Surgisis Gold Graft|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
12041416|NCT00274625|Procedure|Control|Incision is closed without the placement of a graft material (standard of care control)
12041417|NCT00274612|Drug|Telmisartan|
12041418|NCT00274612|Drug|Ramipril|
12041419|NCT00274599|Drug|Telmisartan|
12041420|NCT00274599|Drug|Ramipril|
12041421|NCT00274586|Drug|Aggrenox® modified release capsules|
12041422|NCT00274586|Drug|Aggrenox® modified release capsules matching placebo|
12041423|NCT00274573|Drug|Tiotropium bromide|
12041424|NCT00274560|Drug|Tiotropium|
12041425|NCT00274560|Drug|Salmeterol|
12041426|NCT00274547|Drug|Tiotropium|
12041427|NCT00274534|Drug|Tiotropium|
12041428|NCT00274534|Drug|Salmeterol|
12041429|NCT00274521|Drug|Tiotropium|
12041430|NCT00274508|Drug|tiotropium bromide|
12041431|NCT00274495|Drug|Rosiglitazone and Pegasys/Ribavirin|
12041432|NCT00274469|Drug|fulvestrant|500 mg intramuscular injection
12041433|NCT00274469|Drug|anastrozole|1 mg oral tablet
12041434|NCT00274456|Drug|ABI-007|ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment.
12041435|NCT00274456|Drug|Docetaxel|Docetaxel dosed q3w at 100 mg/m^2
12041436|NCT00274443|Drug|ABI-007 (Abraxane) and Carboplatin|ABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks
12041437|NCT00274430|Drug|dexamethasone 8 mg bid|
12041438|NCT00274430|Drug|tadalafil 10mg bid|
12041439|NCT00274417|Drug|dutasteride|
12041440|NCT00274404|Drug|valacyclovir|
12041441|NCT00274391|Drug|7% NaCl|
12041442|NCT00274391|Drug|Amiloride HCl|
12041443|NCT00274378|Device|ALLOMATRIX injectable putty in distal radius fractures|
12041444|NCT00274365|Procedure|videoconference|
12041445|NCT00274352|Drug|adalimumab|Adalimumab 40 mg administered subcutaneously once weekly or placebo injection administered once weekly for 12 weeks, followed by open-label adalimumab 40 mg administered subcutaneously weekly for an additional 12 weeks.
12041446|NCT00274339|Drug|Prevacid 30mg BID|
12041447|NCT00274339|Behavioral|Lifestyle changes of exercise and diet changes for weight loss and avoidance of reflux inducing foods.|
12041448|NCT00274326|Drug|SR121463B|
12041449|NCT00274313|Drug|552-02|
12041450|NCT00274300|Biological|pPJV7630 administered by PMED|
12041451|NCT00274287|Drug|GM CSF|250 ug/m2 daily for 2 weeks followed by 2 weeks of rest
12041452|NCT00274274|Drug|insulin detemir|
12041453|NCT00274274|Drug|insulin aspart|
12041454|NCT00274261|Drug|C31G|The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.
12041455|NCT00274261|Drug|nonoxynol-9 (N-9)|The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.
12041456|NCT00274248|Drug|MLN518|
12041457|NCT00274235|Drug|sulfadoxine-pyrimethamine / mefloquine|
12041458|NCT00274209|Procedure|Chromoendoscopy with magnification|A blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use.
12041459|NCT00274196|Procedure|ultrasound examination|a single time 10 minutes procedure within the first week after the injury
12041460|NCT00274196|Procedure|MRI scan|a single time 30 minutes procedure, performed always after the ultrasound scan
12041461|NCT00274170|Drug|Octreotide|
12041462|NCT00274157|Behavioral|Behavior|
12041463|NCT00274157|Behavioral|diet control, smoking cessation, exercize|
12041464|NCT00274144|Drug|telmisartan 40 mg|
12041465|NCT00274144|Drug|placebo 40 mg|
12041466|NCT00274131|Drug|Pramipexole 0.125 mg tablets|
12041467|NCT00274131|Drug|Pramipexole 0.5 mg tablets|
12041468|NCT00274118|Drug|telmisartan|
12041472|NCT00274092|Drug|tiotropium inhalation capsules (18 mcg once daily)|
12041473|NCT00274092|Drug|Atrovent MDI (2 puffs of 20 mcg(q.i.d.) in patients|
12041474|NCT00274079|Drug|SPIRIVA|
12041475|NCT00274066|Drug|Tiotropium + placebo|
12041476|NCT00274066|Drug|Tiotropium + ipratropium|
12041477|NCT00274066|Drug|Tiotropium + fenoterol|
12041478|NCT00274053|Drug|tiotropium|
12041479|NCT00274040|Drug|Tiotropium|
12041480|NCT00274040|Drug|Ipratropium|
12041481|NCT00274027|Drug|tiotropium bromide|
12041482|NCT00274014|Drug|Tiotropium|
12041483|NCT00274001|Drug|Nevirapine|
12041484|NCT00273988|Drug|nevirapine|
12041485|NCT00273975|Drug|Nevirapine|
12041486|NCT00273975|Drug|Lamivudine|
12041487|NCT00273975|Drug|Zidovudine|
12041488|NCT00273962|Drug|ipratropium plus salbutamol UDV|
12041489|NCT00273962|Drug|salbutamol UDV|
12041490|NCT00273949|Drug|lactulose|
12041491|NCT00273936|Drug|AVN-944 capsules for oral administration|
12041492|NCT00273910|Drug|gp100:209-217 (210M)|
12041493|NCT00273910|Drug|Montanide ISA-51|
12041494|NCT00273910|Drug|Imiquimod|Apply imiquimod 5% cream to the skin at the site of injection daily for 5 days
12041495|NCT00273897|Device|Phoresor II|
12041496|NCT00273884|Drug|Amonafide L-Malate|
12041497|NCT00273884|Drug|Cytarabine|
12041498|NCT00273871|Drug|Cyclosporin or tacrolimus|
12041499|NCT00273858|Other|There is no Intervention. The study is observational.|The study is observational and the prescription follows the SmPC of etanercept.
12041500|NCT00273845|Behavioral|Motivational interviewing|One session
12041501|NCT00273845|Behavioral|Strengths-Based Case Management|5 sessions
12041502|NCT00273832|Procedure|coronary artery computed tomography angiogram|
12041503|NCT00273832|Procedure|single photon emission computed tomography|
12041504|NCT00273819|Procedure|CT angiography|
12041505|NCT00273806|Behavioral|Intervention for 4 behavioral risks by medical assistants.|
12041506|NCT00273793|Behavioral|Contingency Management|incentives are available for reduced smoking on each study visit which occur each weekday.
12041507|NCT00273780|Behavioral|Adherence counseling|Three adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration.
12041508|NCT00273780|Device|Alarm device|This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.
12041509|NCT00273767|Drug|epoetin beta|800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery
12041510|NCT00273767|Drug|placebo|60ml of NaCl IV slow
12041511|NCT00273754|Drug|Caffeine|Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.
12041512|NCT00273754|Drug|Placebo|Children in group two will receive an amount of normal saline equal to Caffeine
12041513|NCT00273741|Drug|methylphenidate|methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days
12041514|NCT00273741|Drug|placebo comparator|placebo capsules
12041515|NCT00273728|Drug|hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline|hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline
12041516|NCT00273715|Procedure|Surgical wound closure techniques|Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision
12041517|NCT00273715|Procedure|Surgical wound closure techniques (Comparator)|Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision
12041518|NCT00273702|Drug|N-Acetyl Cysteine|
12041519|NCT00273689|Drug|montelukast vs pretreatment with albuterol|montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
12041520|NCT00273689|Drug|montelukast|Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
12041521|NCT00273676|Procedure|Conversion to oral antibiotic treatment after 3 days of intravenous antibiotic treatment|
12041522|NCT00273663|Device|TCES|
12041523|NCT00273650|Drug|methylcobalamin|Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.
12041524|NCT00273650|Other|saline placebo|Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.
12041525|NCT00273624|Drug|Olanzapine|10 mg Olanzapin concurrent to antidepressive medication
12041526|NCT00273624|Drug|Placebo|placebo
12041527|NCT00273611|Behavioral|Pharmacist Education about Vitamin D|
12041528|NCT00273598|Procedure|Moss Miami Spine Instrumentation System|
12041529|NCT00273598|Procedure|Universal Spine Instrumentation System|
12041530|NCT00273585|Device|Personally-tailored educational software program|
12041531|NCT00273572|Other|Moderate Lifestyle Intervention|Two educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up
12041532|NCT00273572|Other|Intensive lifestyle intervention|A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor
12041533|NCT00273559|Drug|prednisone|group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
12041534|NCT00273546|Drug|XRP6976 (Docetaxel/Taxotere)|
12041535|NCT00273533|Drug|Ramipril|
12041536|NCT00273520|Drug|Telithromycin|
12041537|NCT00273507|Drug|Carboplatin and Paclitaxel|
12041538|NCT00273494|Procedure|Surgery|
12041539|NCT00273481|Drug|dorzolamide 2%/timolol maleate 0.5% fixed combination|
12041540|NCT00273481|Drug|latanoprost 0.005%/timolol maleate 0.5% fixed combination|
12041541|NCT00273481|Drug|timolol maleate 0.5%|
12041542|NCT00273481|Drug|placebo|
12041543|NCT00273468|Drug|Granisetron|
12041544|NCT00273455|Drug|bimatoprost 0.03%|
12041545|NCT00273455|Drug|dorzolamide 2%/timolol maleate 0.5% fixed combination|
12041546|NCT00273455|Drug|placebo|
12041547|NCT00273442|Drug|timolol maleate|
12041548|NCT00273442|Drug|dorzolamide/timolol maleate fixed combination|
12041549|NCT00273429|Drug|timolol maleate 0.5%|
12041550|NCT00273429|Drug|dorzolamide/timolol maleate fixed combination|
12041551|NCT00273429|Drug|latanoprost 0.005%|
12041552|NCT00273429|Drug|placebo|
12041553|NCT00273416|Drug|PF-00592379|
12041554|NCT00273416|Drug|Sildenafil 100mg|
12041555|NCT00273403|Behavioral|Maintenance in Care Services|
12041556|NCT00273403|Behavioral|Access to Care Services|
12041557|NCT00273390|Drug|Remicade (infliximab)|
12041558|NCT00273377|Other|Mild intraoperative hypercapnia (50 mmHg vs. 30 mmHg)|
12041559|NCT00273377|Other|Supplemental oxygen (80% vs. 30%)|
12041560|NCT00273377|Drug|Dexamethasone|4 mg
12041561|NCT00273377|Drug|Placebo|placebo
12041562|NCT00273364|Procedure|Hematopoietic Stem Cell Therapy|After mobilization and harvest of stem cells, stem cells will be infused following conditioning regimen
12041563|NCT00273364|Drug|Standard treatment with a conventional drug|Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), or Gilenya (fingolimod)
12041564|NCT00273351|Drug|[123I]B-CIT|Subjects will receive up to 6 mCi of [123I] B-CIT injected intravenously
12041565|NCT00273338|Drug|calcitriol|
12041566|NCT00273338|Drug|docetaxel|
12041567|NCT00273312|Drug|Patupilone|Patupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials
12041568|NCT00273299|Drug|valsartan plus hydrochlorothiazide|
12041569|NCT00273286|Behavioral|family diabetes management intervention|a clinic-integrated, low intensity, multi-component behavioral intervention
12041570|NCT00273273|Procedure|blood draw|
12041571|NCT00273260|Behavioral|individualised bone density feedback and education|
12041572|NCT00273247|Drug|Interferon alpha-2b|
12041573|NCT00273234|Procedure|Autologous Platelet Gel (APG)|
12041574|NCT00273221|Procedure|Glaucoma Implant Surgery|
12041575|NCT00273221|Procedure|trabeculectomy|
12041576|NCT00273221|Procedure|phacoemulsification|
12041577|NCT00273208|Behavioral|10 week behavioral intervention program|
12041578|NCT00273195|Device|Implantable Cardioverter Defibrillator|
12041579|NCT00273182|Device|InSync Model 8040|Subjects with sucessful implants of InSync Model 8040.
12041580|NCT00273182|Device|InSync III Model 8042|Subjects with successful implants of InSync III Model 8042
12041581|NCT00273156|Behavioral|Telephone quitline|
12041582|NCT00273130|Procedure|transnasal endoscopy|
12041583|NCT00273130|Procedure|transoral thin endoscopy|
12041584|NCT00273117|Procedure|transnasal gastroscopy|
12041585|NCT00273104|Procedure|Bariatric surgery|Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
12041586|NCT00273104|Behavioral|Intensive lifestyle intervention|Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.
12041587|NCT00273091|Device|ICD with CRT therapy|permanently CRT pacing
12041588|NCT00273065|Drug|Neosaxitoxin|
12041589|NCT00273052|Drug|Carvedilol Phosphate modified release formulation|
12041590|NCT00273052|Drug|metoprolol succinate|
12041591|NCT00273039|Drug|paroxetine|
12041592|NCT00273026|Drug|salmeterol xinafoate/fluticasone propionate|
12041593|NCT00273013|Drug|GW274150|GW274150 will be available as 30 mg white oval tablets.
12041594|NCT00273013|Drug|Singulair|Singulair will be available as over encapsulated 10 mg orange tablets.
12041595|NCT00273013|Drug|Placebo|Matching placebo for Singulair and GW274150 will be available.
12041596|NCT00273000|Drug|GLP-2|
12041597|NCT00272987|Drug|lapatinib|(GW572016) 1000 mg QD
12041598|NCT00272987|Drug|paclitaxel|80 mg/m2 IV weekly for three weeks
12041599|NCT00272987|Drug|trastuzumab|4 mg/kg loading dose and 2 mg/kg weekly IV
12041600|NCT00272974|Behavioral|Clinic-based counseling|
12041601|NCT00272961|Drug|Placebo|placebo tablet once daily for 12 weeks
12041602|NCT00272961|Drug|TBC3711|10 mg tablets once daily for 10 weeks
12041603|NCT00272961|Drug|TBC3711|50 mg tablet once daily for 10 weeks
12041604|NCT00272961|Drug|TBC3711|100 mg tablet once daily for 10 weeks
12041605|NCT00272961|Drug|TBC3711|200 mg tablet once daily for 10 weeks
12041606|NCT00272948|Drug|Defibrotide|Defibrotide 25 mg/kg/d
12041607|NCT00272948|Drug|Defibrotide|Defibrotide 25 mg/kg/d iv in 4 doses beginning at day of conditioning until day +30 or until discharge from inpatient care (with a minimum treatment of 14 days) if VOD does not occur.
12041608|NCT00272948|Drug|Defibrotide|Defibrotide 25 mg/kg/d iv therapeutically when patients fulfil modified Seattle criteria
12041609|NCT00272935|Drug|Cenestin 0.3 mg Tablets|1 tablet daily
12041610|NCT00272935|Other|Placebo|1 tablet daily
12041611|NCT00272922|Device|hernia repair|
12041612|NCT00272909|Drug|piclozotan low dose|Continuous IV infusion over a period of up to 72 hours of piclozotan
12041613|NCT00272909|Drug|placebo|Continuous IV infusion over a period of up to 72 hours of placebo.
12041614|NCT00272909|Drug|piclozotan high dose|Continuous IV infusion over a period of up to 72 hours of piclozotan
12041615|NCT00272896|Drug|Vasoactive intestinal peptide|
12041616|NCT00272870|Drug|06Benzylguanine|120 mg/m2/day; given Day 1-5 for up to 6 courses in Block 3
12041617|NCT00272870|Genetic|MGMT P140K|Gene manipulated cells, patients are not expected to receive greater than approximately 10 x 10e6 transduced CD34+ cells/kg
12041618|NCT00272870|Device|Meltenyi CliniMacs|Device used for CD34+ cell separation of peripheral collection
12041619|NCT00272857|Genetic|Retrovirus Construct|This study will use an experimental gene transfer procedure performed in a laboratory to insert a new FA gene into the participant's bone marrow cells. The gene-corrected bone marrow cells will then be re-infused into the participant and participants will be observed for successful gene transfer
12041620|NCT00272844|Drug|crystalline cholesterol oil-based suspension|200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
12041621|NCT00272831|Drug|Cilostazol|Cilostazol 100 mg twice daily
12041622|NCT00272831|Drug|Placebo|1 tablet twice daily
12041623|NCT00272805|Drug|carvedilol|
12041624|NCT00272792|Drug|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
12041625|NCT00272792|Drug|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
12041626|NCT00272779|Drug|ATV|300mg Oral capsules for 96 weeks
12041627|NCT00272779|Drug|RTV|100mg Oral Capsules for 96 weeks
12041628|NCT00272779|Drug|Tenofovi-Emtricitabine (TDF/FTC) tablet|One tablet with 300 mg - 200 mg once a day for 96 weeks.
12041629|NCT00272779|Drug|LPV|400 mg (3 133mg capsules) BID for 96 weeks
12041630|NCT00272766|Drug|pegaptanib sodium|
12041631|NCT00272753|Drug|budesonide/formoterol Turbuhaler|
12041632|NCT00272753|Drug|formoterol Turbuhaler|
12041633|NCT00272753|Drug|salbutamol|
12041634|NCT00272740|Drug|Fulvestrant|
12041635|NCT00272727|Behavioral|Dialog tool for caregivers|
12041636|NCT00272714|Drug|Afimoxifene (0.057%) in hydroalcoholic gel|
12041637|NCT00272701|Drug|Esomeprazole|
12041638|NCT00272701|Drug|Other PPI marketed in Sweden|
12041639|NCT00272688|Drug|Levodopa (drug), intraduodenal administration|
12041640|NCT00272675|Drug|Chlorhexidine gluconate (drug) vs placebo|
12041641|NCT00272662|Drug|peginesatide|
12041642|NCT00272649|Biological|AGS-003|Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)
12041643|NCT00272636|Procedure|Radiofrequency catheter ablation|
12041644|NCT00272636|Drug|Amiodarone and cardioversion|
12041645|NCT00272623|Procedure|Seldinger technique or venous cut-down for port placement|
12041646|NCT00272610|Drug|0.4% Retinol Cream|
12041647|NCT00272597|Drug|Risperidone|See Detailed Description.
12041648|NCT00272584|Drug|Risperidone|
12041649|NCT00272571|Procedure|External counter pulsation therapy|
12041650|NCT00272558|Drug|Carboplatin and Vinorelbine|
12041651|NCT00272545|Behavioral|Normalization of Eating (NOE)|The NOE is a 6-week program based on principles of CBT. Participants will receive individual therapy, as well as take part in group and family therapy sessions. In addition, participants will be supervised while eating meals.
12041652|NCT00272545|Behavioral|Treatment As Usual (TAU)|Treatment as usual will include standard care for a person with an eating disorder.
12041653|NCT00272532|Drug|Thiocolchicoside|
12041654|NCT00272519|Behavioral|Life Skills Intervention|Developed to promote life skills among young adolescents perinatally infected with HIV
12041655|NCT00272506|Drug|inhaled corticosteroid|
12041656|NCT00272506|Drug|long-acting beta2-agonist|
12041657|NCT00272493|Biological|Hepatitis B virus vaccine with GM-CSF adjuvant|Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.
12041658|NCT00272493|Biological|Hepatitis B virus vaccine|Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.
12041659|NCT00272480|Drug|Zidovudine/lamivudine|
12041660|NCT00272480|Drug|Placebos|
12041661|NCT00272467|Drug|Rebamipide|"Brand name: Mucosta® Tab.
~Generic name: Rebamipide.
~Chemical name:
~(±)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl]propionic acid.
~Formulation: Tablet (White, film-coated tablet).
~Strength: One tablet contains rebamipide 100mg.
~Storage condition: 15℃~25℃.
~Manufacturer: Korea Otsuka Pharmaceuticals"
12041662|NCT00272467|Drug|Omeprazole|"Brand name: Losec® Cap.
~Generic name: Omeprazole.
~Chemical name:
~5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃~25℃. 7) Manufacturer: AstraZenaca Korea."
12041663|NCT00272454|Drug|Cilostazol|
12041664|NCT00272454|Drug|Aspirin|
12041665|NCT00272441|Drug|inhaled corticosteroids|
12041666|NCT00272428|Behavioral|ascorbic acid, vitamin E, beta carotene, selenium, zinc|
12041667|NCT00272415|Drug|INO-1001|Intravenous repeating dose
12041668|NCT00272415|Drug|temozolomide|Oral repeating dose
12041669|NCT00272402|Behavioral|Cognitive Behavioral Intervention|Intervention consists of simulated case based learning for physicians.
12041670|NCT00272402|Behavioral|Office System Redesign Intervention|Intervention consists of clinical decision support within the electronic medical record.
12041671|NCT00272350|Drug|Steroids|
12041672|NCT00272350|Drug|ZD6474|
12041673|NCT00272337|Drug|Aspirin|Dosage
12041674|NCT00272324|Drug|Aspirin|
12041675|NCT00272324|Drug|Folate|
12041676|NCT00272311|Drug|Aspirin|Dosage
12041677|NCT00272285|Drug|Ramosetron|IV, concomitant administration with dexamethasone
12041678|NCT00272285|Drug|Granisetron|IV, concomitant administration with dexamethasone
12041679|NCT00272272|Behavioral|Music Therapy|Listening to Music while standing
12041680|NCT00272259|Procedure|Participants will interact with up to two small robots and a visual display|
12041681|NCT00272246|Procedure|deep brain stimulation of the internal globus pallidus|
12041786|NCT00271271|Drug|oxaliplatine / gemcitabine / Vinorelbine|
12041787|NCT00271258|Drug|SODIUM DIVALPROATE|
12041682|NCT00272220|Behavioral|modified directly observed therapy (mDOT)|Peers individually administered the 6-week mDOT intervention at the Beira Day Clinic to mDOT participants during their morning weekday dose. Evening and weekend doses were not observed. Nighttime and weekend doses were self-administered. As part of the daily interaction with participants, peers provided social support, information about the benefits and side effects of HAART, how to address stigma's effect on adherence, and encouragement to participate in community support groups. The peers also provided an important link between the individual and other members of the HIV clinic team and the community.
12041683|NCT00272207|Drug|Nabilone|Oral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week.
12041684|NCT00272194|Device|Ambu Laryngeal Mask|
12041685|NCT00272194|Device|Aintree Exchange Catheter|
12041686|NCT00272194|Device|Laryngeal Mask Airway|
12041687|NCT00272181|Drug|Proxinium|Intratumoral administration of Proxinium directly to target tumors.
12041688|NCT00272168|Behavioral|Maryland Program for Vocational Effectiveness|psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)
12041689|NCT00272168|Other|Supportive Treatment for SMI|Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
12041690|NCT00272155|Behavioral|Educational intervention|Educational outreach visits to the CME-groups, work-shops, audit and feedback
12041691|NCT00272155|Behavioral|Educational intervention program|The 433 recruited GPs had a total of 1336 717 office consultations of which 171 679 (12.8%) were RTIs encounters for 118 621 different patients. The GPs participated in peer continuing medical education (CME) groups in southern Norway. A multifaceted intervention was tailored, where key components were educational outreach visits to the CME-groups, work-shops, audit and feedback. Prescription Peer Academic Detailers conducted the educational outreach visits. During these visits, evidence-based recommendations of antibiotic prescriptions for RTIs were presented and software handed out for installation in participants PCs, enabling collection of prescription data. These data was linked to corresponding data from the Norwegian Prescription Database (NorPD). Main outcomes are baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline one year after the initiation of the tailored pedagogic intervention.
12041692|NCT00272142|Drug|Zinc|
12041693|NCT00272142|Drug|Placebo|
12041694|NCT00272116|Drug|Zinc and vitamin A single dose at enrollment|10 mg/day of elemental zinc as zinc gluconate to infants and 20 mg/day to older children
12041695|NCT00272116|Drug|Placebo and vitamin A single dose at enrollment|Placebo was plain glucose. Vitamin A 100,000 IU to infants and 200,000 IU to older children
12041696|NCT00272103|Drug|Itopride (drug)|
12041697|NCT00272090|Drug|Insulin glargine|
12041698|NCT00272077|Drug|Insuline glargine|
12041699|NCT00272064|Drug|Insulin glulisine|individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal < 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous
12041700|NCT00272064|Drug|Insulin glargine|individualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous
12041701|NCT00272064|Drug|Metformin|1000 mg b.i.d, since the qualification phase, oral
12041702|NCT00272051|Drug|SR57746A|
12041703|NCT00272038|Drug|Tarceva|150mg QD
12041704|NCT00272025|Drug|Escitalopram|10mg to 20mg tablet daily for 6 weeks
12041705|NCT00272025|Drug|placebo|
12041706|NCT00272012|Drug|Insulin glulisine|
12041707|NCT00271999|Behavioral|Nocturnal home hemodialysis|Six times per week nocturnal home hemodialysis
12041708|NCT00271973|Drug|Oxycodone|
12041709|NCT00271960|Behavioral|CenteringPregnancy|Following the initial intake into obstetric care in the usual manner, participants will be invited to join with 8 to 12 other women/couples/teens with similar due dates, meeting together regularly during their pregnancy.
12041710|NCT00271960|Behavioral|CenteringPregnancyPlus|CenteringPregnancyPlus is a modified program that integrated HIV/STD prevention components with the group prenatal care model. Participants will learn skill-building in the areas of efficacy, risk assessment, negotiation skills and prevention.
12041711|NCT00271960|Behavioral|Usual care|Participants will receive usual prenatal care.
12041712|NCT00271947|Biological|Autologous Stem Cell Transplantation|Autologous Stem Cell Transplantation will be performed after conditioning regimen
12041713|NCT00271934|Biological|Immune ablation and hematopoietic stem cell support.|Autologous hematopoietic stem cell transplant
12041714|NCT00271921|Behavioral|Calorie controlled diet|
12041715|NCT00271908|Behavioral|Community Mobilization|"ATN 040b is the evaluation sub-study for ATN 040, Phase III of C2P. Phase III is a community mobilization intervention aimed at reducing HIV rates among youth via community structural change. ATN 040b involves annual anonymous data collection with two cohorts per participating ATN/C2P site. Both cohorts will represent the site's target population, or population of focus."
12041716|NCT00271869|Procedure|Extracorporeal photoimmunotherapy|
12041717|NCT00271856|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|8 week MBSR course
12041718|NCT00271856|Behavioral|HIV-education and self-management workshop|8-week group covering a variety of educational topics about managing HIV infection.
12041719|NCT00271817|Drug|Comparator: ezetimibe/simvastatin + niacin (ER)|ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
12041720|NCT00271817|Drug|Comparator: Placebo to ezetimibe/simvastatin|ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.
12041721|NCT00271817|Drug|Comparator: niacin (ER) tablet|niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
12041722|NCT00271817|Drug|Comparator: ezetimibe (+) simvastatin|ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.
12041723|NCT00271817|Drug|Comparator: Placebo to Niacin (ER)|Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
12041724|NCT00271817|Drug|Comparator: ezetimibe/simvastatin and niacin (ER)|ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks
12041725|NCT00271817|Drug|Comparator: ezetimibe and simvastatin|ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
12041726|NCT00271817|Drug|Comparator: Placebo to niacin (ER)|Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
12041727|NCT00271804|Drug|bortezomib|
12041728|NCT00271791|Drug|Prednisone|PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
12041729|NCT00271791|Drug|Prednisone|PO, Placebo, 17 days
12041730|NCT00271778|Procedure|mastoidotympanoplasty and tympanoplasty|
12041731|NCT00271765|Drug|INO-1001|
12041732|NCT00271752|Procedure|Earlier therapeutic changes regarding infection|For every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified
12041733|NCT00271739|Device|Telemedicine Unit (HTU)|This study involves the deployment of a home telemedicine unit (HTU). The HTU provides 3 critical functions for patients: videoconferencing, access to information resources and e-mail through a web-enabled workstation, and medical data acquisition through an electronic device interface. The HTUs also included a glucometer and a blood pressure cuff interfaced directly with the HTU.
12041734|NCT00271739|Other|usual care|usual diabetes care, as provided by primary care providers
12041735|NCT00271726|Procedure|Osteosynthesis with palmar locking plate|
12041736|NCT00271726|Procedure|Osteosynthesis with external fixator|
12041737|NCT00271726|Procedure|Osteosynthesis with Kirschner wires|
12041738|NCT00271713|Drug|ibandronate, calcium and vitamin D|1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
12041739|NCT00271713|Drug|placebo,calcium and vitamin D|2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily
12041740|NCT00271700|Behavioral|Order Set, Education, Feedback|
12041741|NCT00271687|Behavioral|Exercise training|
12041742|NCT00271674|Device|Q-switched YAG laser|
12041743|NCT00271635|Drug|Placebo|Placebo 4 capsules b.i.d. during 1 year
12041744|NCT00271635|Drug|ascorbic acid|Ascorbic acid 1000 mg (4 capsules of 250 mg) b.i.d. during 1 year
12041745|NCT00271609|Drug|Bevacizumab|10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes.
12041746|NCT00271596|Drug|20mg daily citalopram|a selective serotonin reuptake inhibitor (SSRI) treatment administered over 16 weeks
12041747|NCT00271596|Drug|Placebo|a daily matching placebo administered over 16 weeks
12041748|NCT00271583|Drug|CDB-2914|
12041749|NCT00271583|Drug|levonorgestrel|
12041750|NCT00271570|Drug|Infliximab (Remicade)|Remicade was 5 mg/kg IV (single dose)
12041751|NCT00271570|Biological|Intravenous immunoglobulin (IVIG)|2nd dose of IVIG (2g/kg)
12041752|NCT00271557|Drug|nesiritide|
12041753|NCT00271544|Device|Pacing Lead|implant and follow-up of study device
12041754|NCT00271518|Drug|growth hormone (somatropin)|dosing regimen is weight based.
12041755|NCT00271505|Drug|Bevacizumab (Avastin)|15 mg/kg intravenously (IV) every 3 weeks
12041756|NCT00271505|Drug|Carboplatin|AUC 6 IV every 3 weeks
12041757|NCT00271505|Drug|Docetaxel|75 mg/m2 IV every 3 weeks
12041758|NCT00271492|Drug|Atrasentan|1 10mg capsule to be taken daily for 6 month study period.
12041759|NCT00271492|Drug|Atrasentan|1 10mg capsule per day for the 6 month study period.
12041760|NCT00271492|Drug|atrasentan|One 10 mg capsule per day for 6 month study period
12041761|NCT00271479|Biological|A, C, Y, W135 meningococcal polysaccharide vaccine|
12041762|NCT00271466|Drug|DuragesicÂ® (fentanyl) Therapeutic Transdermal System (TTS)|
12041763|NCT00271453|Drug|Durogesic® (fentanyl transdermal drug delivery system)|
12041764|NCT00271440|Procedure|skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)|
12041765|NCT00271427|Drug|L-Selenomethionine|
12041766|NCT00271414|Drug|Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)|
12041767|NCT00271401|Other|Angioplasty|
12041768|NCT00271401|Other|Intracoronary Stent|
12041769|NCT00271401|Drug|Abxicimab|
12041770|NCT00271401|Drug|Heparin|
12041771|NCT00271401|Drug|Placebo|
12041772|NCT00271388|Device|Transcutaneous current to the vestibular nerve|Delivery of randomly oscillating low level current
12041773|NCT00271375|Behavioral|Caring For You, Caring For Me|5-week Education and Support Program for Caregivers of older adults.
12041774|NCT00271375|Behavioral|Caring for you, caring for me + social worker|5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
12041775|NCT00271375|Behavioral|Control|Control group usual care
12041776|NCT00271362|Behavioral|Amputation rehabilitation exercise program|participants will be physically exercised with a full array of exercise methodologies.
12041777|NCT00271362|Procedure|Osteomyoplasty vs. routine long posterior flap|participants enrolled randomly in one of two surgical procedures.
12041778|NCT00271349|Drug|Budesonide|
12041779|NCT00271336|Drug|Pentoxifylline|
12041780|NCT00271323|Drug|docetaxel and cisplatin|Docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemo-radiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy.
12041781|NCT00271323|Radiation|radiotherapy|Docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
12041782|NCT00271310|Drug|hypertonic saline|
12041783|NCT00271297|Behavioral|Pelvic floor muscle training|
12041784|NCT00271284|Drug|insulin glulisine / insulin glargine|insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
12041785|NCT00271284|Drug|insulin glulisin / insulin detemir|insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
12041788|NCT00271245|Dietary Supplement|200 µg selenium as selenate|200 µg selenium as selenate
12041789|NCT00271245|Dietary Supplement|400 µg selenium as selenate|400 µg selenium as selenate
12041790|NCT00271245|Dietary Supplement|200 µg selenium as selenomethionine|200 µg selenium as selenomethionine
12041791|NCT00271245|Dietary Supplement|Placebo|Placebo
12041792|NCT00271232|Device|Cardiac resynchronization therapy|
12041793|NCT00271219|Drug|Methadone|daily oral dosing 20-140 mg
12041794|NCT00271219|Drug|Buprenorphine|sl daily 2-32 mg
12041795|NCT00271206|Drug|Progesterone|compared to placebo
12041796|NCT00271206|Drug|sugar pill|Compared to progesterone
12041797|NCT00271193|Behavioral|Weight loss counseling|A comparison of weight loss advice provided by primary care physicians to advice plus brief weight loss counseling provided by medical assistants. Participants in both groups receive weight loss materials.
12041798|NCT00271180|Device|Device|
12041799|NCT00271167|Drug|INO-1001|
12041800|NCT00271154|Device|Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT|All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.
12041801|NCT00271115|Behavioral|Kangaroo Holding|Mothers will be asked to Kangaroo hold their infants two times during the first week of life.
12041802|NCT00271102|Procedure|anterior vaginal repair (colporrhaphy)|vaginal repair
12041803|NCT00271102|Procedure|abdominal paravaginal defect repair|abdominal repair
12041804|NCT00271089|Procedure|PBSC Collection|
12041805|NCT00271089|Procedure|Bone Marrow Harvest|
12041806|NCT00271089|Device|CliniMacs Cell Selection System|
12041807|NCT00271076|Procedure|IVUS|
12041808|NCT00271076|Device|CAS|
12041809|NCT00271076|Procedure|CEA|
12041810|NCT00271063|Drug|Liposomal Annamycin|3-day IV infusion
12041811|NCT00271050|Other|external beam radiotherapy plus 90-Y ibritumomab tiuxetan|combination of EBRT followed by radioimmunotherapeutic 90-Y ibritumomab tiuxetan
12041812|NCT00271037|Procedure|Colpocleisis prolapse repair surgery|
12041813|NCT00271037|Procedure|sling or other to treat or prevent stress incontinence|
12041814|NCT00271024|Drug|Naltrexone (drug)|50 mg q.d. for 13 weeks
12041815|NCT00271024|Drug|Placebo (for Naltrexone)|Sugar pill manufactured to mimic Naltrexone tablet
12041816|NCT00271011|Drug|Mitomycin C|Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
12041817|NCT00271011|Drug|Cetuximab|Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
12041818|NCT00271011|Drug|Irinotecan.|Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2.
12041819|NCT00270998|Behavioral|Behavioral Therapy|Pelvic muscle training and exercises
12041820|NCT00270998|Device|Intravaginal Pessary|Intravaginal pessary
12041821|NCT00270998|Device|Pessary combined with behavioral therapy|Intravaginal pessary and behavioral therapy
12041822|NCT00270985|Behavioral|Almonds in a calorie controlled diet|Prescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes
12041823|NCT00270985|Behavioral|Nut free diet|Calorie controlled diet free of nuts for adults with pre-type 2 diabetes
12041824|NCT00270972|Device|Bilayered Cellular Matrix (OrCel)|
12041825|NCT00270959|Behavioral|Cognitive Behavioral Therapy|Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
12041826|NCT00270959|Behavioral|Motivational Interviewing|Motivational interviewing is designed to address alcohol and drug use.
12041827|NCT00270959|Drug|FDA-Approved Anti-Anxiety Medications|Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
12041828|NCT00270959|Behavioral|Standard Care Control|Standard care control includes the usual treatment for injured trauma survivors.
12041829|NCT00270946|Device|Bilayered Cellular Matrix (OrCel)|
12041830|NCT00270933|Device|Registry|
12041831|NCT00270920|Behavioral|Lactation counseling|
12041832|NCT00270907|Drug|CT-2103|135 mg/m^2 IV on Day 1.
12041833|NCT00270907|Drug|Gemcitabine|1000 mg/m^2 IV on Day 1 and 8.
12041834|NCT00270894|Drug|epirubicin|epirubicin (100 mg/m^2) every 2 weeks for 4 cycles
12041835|NCT00270894|Drug|cyclophosphamide|cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles
12041836|NCT00270894|Drug|docetaxel|docetaxel (75 mg/m^2) every 2 weeks for 4 cycles
12041837|NCT00270894|Drug|trastuzumab|trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments
12041838|NCT00270881|Procedure|Cord blood transplantation|unrelated cord blood transplantation
12041839|NCT00270881|Radiation|TBI|Total body irradiation (TBI) 12Gy
12041840|NCT00270881|Drug|cyclophosphamide|cyclophosphamide 120mg/kg
12041841|NCT00270881|Drug|cytarabine|cytarabine 3g/m2x4
12041842|NCT00270868|Procedure|Double guide wire technique|
12041843|NCT00270868|Procedure|Standard bile duct cannulation|
12041844|NCT00270855|Procedure|Arm Crank Ergometry|Use of an upper body cycle to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
12041845|NCT00270855|Procedure|FES Cycle Ergometer|Use of an FES cycle ergometer to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
12041846|NCT00270842|Behavioral|Tai Chi|This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
12042308|NCT00267046|Drug|Vincristine|2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen.
12041847|NCT00270842|Behavioral|Functional Balance|This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
12041848|NCT00270842|Behavioral|Education Control group|This control group participated in 10 weeks of general health education classes.
12041849|NCT00270829|Drug|nesiritide|Drug given intrarenally or placebo
12041850|NCT00270816|Drug|Interferon-ß-1b|250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months
12041851|NCT00270816|Drug|Interferon ß-1b|250 micrograms (8 MIU) administered subcutaneously (sc) every other day
12041852|NCT00270803|Drug|Tetra Hydro Cannabinol (THC)|Oral THC 13mg and 17mg smoked in low nicotine cigarettes
12041853|NCT00270790|Drug|Amifostine|Amifostine will be given at dose of 500 mg IV within one hour before radiation
12041854|NCT00270790|Drug|Carboplatin|Carboplatin for 100 mg/m2 and will be administered after the taxol infusion
12041855|NCT00270790|Drug|Taxol|Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose
12041856|NCT00270790|Device|Radiotherapy|Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
12041857|NCT00270777|Drug|adrenaline, promethazine, hydrocortisone|
12041858|NCT00270751|Procedure|1 apical pleurectomy|
12041859|NCT00270751|Procedure|2 pleural abrasion + minocycline pleurodesis|
12041860|NCT00270738|Procedure|Indirect training of the PFMs via transversus abdominis|Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities.
12041861|NCT00270738|Procedure|pelvic floor muscle training|Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training
12041862|NCT00270738|Procedure|home exercise|PFM exercise at home: at least six high-intensity (near-maximum) contractions 3 times per day at home, with an aim at holding each muscle contraction for 10 seconds, with at least a 10-second rest between contractions.
12041863|NCT00270699|Biological|rDEN4delta30-200,201|Live attenuated dengue 4 vaccine (one of three doses)
12041864|NCT00270699|Biological|Placebo|Placebo for rDEN4delta30-200,201
12041865|NCT00270673|Procedure|Early lactate-directed therapy|
12041866|NCT00270660|Behavioral|biopsy, audiometry, ET function test, ear swab culture, DNE|
12041867|NCT00270647|Dietary Supplement|Vitamin E|400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
12041868|NCT00270647|Dietary Supplement|Vitamin C|500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
12041869|NCT00270647|Dietary Supplement|Multivitamin|Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
12041870|NCT00270647|Dietary Supplement|Beta-carotene|50 mg Lurotin or placebo on alternate days (provided by BASF)
12041871|NCT00270634|Drug|Voclosporin|voclosporin 0.4, 0.6, 0.8 mg/kg po BID
12041872|NCT00270634|Drug|tacrolimus|tacrolimus 0.05 mg/kg po BID
12041873|NCT00270621|Behavioral|FHP Night time ENuresis Intervention|Urine alarm/evidence-based psychological Intervention
12041874|NCT00270608|Procedure|Quantitative Computed Tomography of the tibia and spine|a single time 1 minute procedure
12041875|NCT00270608|Procedure|MRI of the spine and the right knee|a single time 45 minutes procedure
12041876|NCT00270608|Procedure|Blood test|A single time procedure to check lipid profile and hemoglobin A1C
12041877|NCT00270582|Drug|Taxotere, Cisplatin, Gemcitabine|
12041878|NCT00270569|Drug|PhyxolTM, Cisplatin|
12041879|NCT00270556|Drug|tenofovir disoproxil fumarate|
12041880|NCT00270556|Drug|Abacavir|
12041881|NCT00270543|Drug|Taxotere, Fluorouracil, Leucovorin|
12041882|NCT00270530|Drug|Sulfadoxine-pyrimethamine (Fansidar)|
12041883|NCT00270517|Drug|EDP-420 / Duration of Treatment - 3 days|
12041884|NCT00270517|Drug|Telithromycin / Duration of Treatment - 7 days|
12041885|NCT00270504|Device|Memokath stenting|Urethral Stenting
12041886|NCT00270491|Drug|Paclitaxel|
12041887|NCT00270491|Drug|Capecitabine|
12041888|NCT00270478|Drug|Erythropoietin and Hydroxyurea|
12041889|NCT00270465|Drug|VRC-HIVDNA016-00-VP|
12041890|NCT00270465|Drug|VRC-HIVADV014-00-VP|
12041891|NCT00270452|Drug|WT1 and PR1 Peptide Vaccine|
12041892|NCT00270439|Procedure|removal of omentum|patients with type 2 diabetes had their omentum removed
12041893|NCT00270426|Drug|Benazepril|
12041894|NCT00270413|Drug|SU11248|sutent 50 mg daily 4w on 2w off
12041895|NCT00270400|Drug|nesiritide|
12041896|NCT00270387|Drug|Natrecor (nesiritide)|
12041897|NCT00270374|Drug|nesiritide|
12041898|NCT00270361|Drug|nesiritide|
12041899|NCT00270361|Drug|usual long term cardiac medications|
12041900|NCT00270361|Drug|nesiritide|
12041901|NCT00270348|Drug|ciclesonide|
12041902|NCT00270335|Drug|Propofol|
12041903|NCT00270322|Drug|Marcaine 0.166% + Fentanyl 3.33 mcg/ml|
12041904|NCT00270322|Drug|Morphine sulphate|
12041905|NCT00270309|Behavioral|Self-management|
12041906|NCT00270296|Drug|Trizivir|300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
12041907|NCT00270296|Drug|Lamivudine/Zidovudine|150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
12041908|NCT00270296|Drug|Lopinavir/Ritonavir|400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
12041909|NCT00270296|Drug|Nevirapine|200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
12041910|NCT00270283|Drug|epoetin alfa|
12041911|NCT00270270|Drug|epoetin alfa|
12041912|NCT00270257|Drug|Buprenorphine/Naloxone|Oral tablet
12041913|NCT00270244|Behavioral|Group interpersonal psychotherapy for depressed adolescents (IPT-AG)|Participants assigned to IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. Sessions will focus on problems in interpersonal relationships.
12042077|NCT00268931|Behavioral|Movement Training|This group of infants underwent specific movement training activities two times per day with their parents.
12041914|NCT00270244|Behavioral|Treatment as usual (TAU)|TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency.
12041915|NCT00270231|Drug|Naltrexone|"All participants took naltrexone during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo; all study medication periods were separated by a 5-7 day washout period.
~Dosing of the naltrexone was the same for all participants: Day 1: 12.5mg, Day 2: 25mg, Days 3 and 4: 50mg."
12041916|NCT00270231|Drug|Placebo|"All participants took a placebo (sugar pill) during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo.
~Placebo capsules matched the naltrexone in color, weight and inactive ingredients. The only difference the lack of active naltrexone in each capsule."
12041917|NCT00270218|Biological|VRC-HIVADV014-00-VP|HIV-1 recombinant adenoviral vector vaccine given as a 1 mL intramuscular injection in the deltoid
12041918|NCT00270218|Biological|VRC-HIVDNA009-00-VP|HIV-1 DNA plasmid vaccine given as a 1 mL intramuscular injection in the deltoid
12041919|NCT00270218|Biological|FFB|Adenoviral vector FFB given as a 1 mL intramuscular injection in the deltoid
12041920|NCT00270218|Biological|PBS|phosphate buffered saline
12041921|NCT00270205|Biological|LC002 standard vaccination|0.1 mg DNA/participant, 0.8 ml total administered subcutaneously
12041922|NCT00270205|Biological|LC002 high-dose vaccination|0.4 mg DNA/participant, 3.2 ml total administered subcutaneously
12041923|NCT00270205|Biological|LC002 placebo vaccination|Placebo vaccination administered subcutaneously
12041924|NCT00270192|Behavioral|individual lactation counseling and educational material|
12041925|NCT00270192|Behavioral|educational material alone|
12041926|NCT00270192|Behavioral|routine antenatal care without educational intervention|
12041927|NCT00270179|Drug|epoetin alfa|
12041928|NCT00270166|Drug|epoetin alfa|
12041929|NCT00270153|Drug|enalapril|5mg enalapril daily for 6 months
12041930|NCT00270153|Drug|Placebo|5mg enalapril-matching placebo daily for 6 months
12041931|NCT00270140|Drug|epoetin alfa|
12041932|NCT00270127|Drug|Epoetin alfa|
12041933|NCT00270114|Drug|epoetin alfa|
12041934|NCT00270101|Drug|epoetin alfa|
12041935|NCT00270088|Drug|epoetin alfa|
12041936|NCT00270075|Drug|epoetin alfa|
12041937|NCT00270062|Drug|epoetin alfa|
12041938|NCT00270049|Drug|epoetin alfa|
12041939|NCT00270036|Drug|epoetin alfa|
12041940|NCT00270023|Drug|epoetin alfa|
12041941|NCT00270010|Drug|epoetin alfa|
12041942|NCT00269997|Drug|epoetin alfa|
12041943|NCT00269984|Drug|Epoetin alfa|
12041944|NCT00269971|Drug|epoetin alfa|
12041945|NCT00269958|Drug|epoetin alfa|
12041946|NCT00269945|Drug|epoetin alfa|
12041947|NCT00269932|Drug|levofloxacin|
12041948|NCT00269919|Drug|Risperidone Long-Acting Injectable (RLAI)|The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
12041949|NCT00269906|Drug|Abciximab|
12041950|NCT00269906|Drug|Placebo|
12041951|NCT00269893|Drug|Abciximab|0.25 mg/kg of body weight of abciximab either bolus or infusion.
12041952|NCT00269893|Drug|Placebo|Matching Placebo soulution either bolus or infusion.
12041953|NCT00269880|Drug|Placebo|Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.
12041954|NCT00269880|Drug|Heparin|Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
12041955|NCT00269880|Drug|Abciximab|Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
12041956|NCT00269867|Drug|Placebo|Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
12041957|NCT00269867|Drug|Infliximab 3 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
12041958|NCT00269867|Drug|Infliximab 10 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
12041959|NCT00269854|Drug|Infliximab 5 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
12041960|NCT00269854|Drug|Infliximab 10 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
12041961|NCT00269854|Drug|Infliximab 20 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 20 mg/kg will be administered as infusion at Week 0, 2 and 6.
12041962|NCT00269854|Drug|Placebo|Matching placebo will be adminstered at Week 0, 2 and 6.
12041963|NCT00269841|Drug|Infliximab 10 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
12041964|NCT00269841|Drug|Infliximab 5 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
12041965|NCT00269841|Drug|Placebo|Matching placebo will be adminstered at Week 0, 2 and 6.
12041966|NCT00269828|Drug|paclitaxel|
12041967|NCT00269828|Drug|paclitaxel poliglumex|
12041968|NCT00269815|Drug|methylphenidate HCl|
12041969|NCT00269802|Drug|OROS methylphenidate HCl|
12041970|NCT00269802|Drug|Ritalin|
12041971|NCT00269802|Drug|Placebo|
12041972|NCT00269789|Drug|Ritalin|
12041973|NCT00269789|Drug|OROS Methylphenidate HCl|
12041974|NCT00269789|Drug|Placebo|
12041975|NCT00269776|Drug|Placebo|Treatment C: Three OROS placebo tablets once daily + 1 placebo capsule 3x times/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.
12042078|NCT00268931|Behavioral|Social Training|This group underwent special social interactions with their parents two times each day.
12042079|NCT00268918|Drug|Docetaxel|Participants may continue receiving study drug as long as their disease does not worsen
12041976|NCT00269776|Drug|OROS (methylphenidate HCl)|Treatment A: 1, 2, or 3 OROS methylphenidate 18-mg tablets + 0, 1, or 2 OROS placebo tablets (3 tablets in total) once daily + 1 placebo capsule 3x/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.
12041977|NCT00269776|Drug|Ritalin (methylphenidate)|Treatment B: 5, 10, or 15-mg tablets (encapsulated/single capsule) 3 times a day + 3 OROS placebo tablets once daily for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.
12041978|NCT00269763|Drug|Fentanyl Transdermal Therapeutic System (TTS)|
12041979|NCT00269750|Drug|OROS® oxybutynin or Ditropan®|
12041980|NCT00269737|Drug|Fentanyl Transdermal Therapeutic System (TTS)|
12041981|NCT00269724|Drug|OROS® oxybutynin|
12041982|NCT00269685|Drug|vasopressin|
12041983|NCT00269672|Biological|13-valent Pneumococcal Conjugate Vaccine|
12041984|NCT00269646|Behavioral|Low-carbohydrate and high-carbohydrate diets|Each subject will consume two different ad libitum diets, each for four weeks, with a 4-week washout period inbetween each diet.
12041985|NCT00269633|Device|Blue Light Box 467 nm|467 nm Blue LED Light
12041986|NCT00269633|Device|Red Light Box 657 nm|657 nm Red LED Light
12041987|NCT00269620|Drug|ethinyl estradiol/etonogestrel vaginal ring|vaginal ring for cyclic use (3 weeks in, 1 week out)
12041988|NCT00269620|Drug|ethinyl estradiol/norelgestromin transdermal contraceptive|contraceptive patch worn for 7 days and replaced for use for 3 consecutive weeks followed by a one-week patch free interval
12041989|NCT00269607|Drug|Implantation of naltrexone implants|
12041990|NCT00269594|Drug|Lamictal (lamotrigine)|
12041991|NCT00269581|Other|Educational CD-rom|Educational CD-Rom
12041992|NCT00269581|Other|Headstrong CD-rom|Headstrong CD-rom
12041993|NCT00269568|Drug|mifepristone and misoprostol|
12041994|NCT00269555|Drug|Genistein Combined Polysaccharide (GCP)|
12041995|NCT00269542|Drug|Zinc and iron folic acid - Intervention|The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.
12041996|NCT00269542|Drug|Iron Folic Acid alone - Placebo|The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
12041997|NCT00269529|Procedure|femoral nerve block|
12041998|NCT00269529|Procedure|knee infiltration and injection via catheter|
12041999|NCT00269516|Drug|pardoprunox|fixed dose 6 mg
12042000|NCT00269516|Drug|Pardoprunox|fixed dose 12 mg
12042001|NCT00269516|Drug|Pardoprunox|12-42mg
12042002|NCT00269516|Drug|Placebo|Placebo
12042003|NCT00269503|Procedure|Prone Distraction|
12042004|NCT00269503|Procedure|Side-Posture Manipulation|
12042005|NCT00269503|Procedure|Side-Posture Manipulation & Prone Distraction|
12042006|NCT00269503|Procedure|Usual Care (Control Group)|
12042007|NCT00269490|Behavioral|Yoga Nidra|
12042008|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12042009|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12042010|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12042011|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
12042012|NCT00269438|Drug|5 ASA, enemas, suppositories, corticosteroids|
12042013|NCT00269425|Behavioral|American Heart Association Step 2 diet|Low fat diet with patient education and diet analysis
12042014|NCT00269425|Behavioral|Mediterranean diet|Mediterranean style diet with patient education and diet analysis
12042015|NCT00269412|Drug|Rifaximin|
12042016|NCT00269399|Drug|Rifaximin (Xifaxan)|
12042017|NCT00269399|Drug|Vancomycin|
12042018|NCT00269386|Drug|Clarithromycin|Clarithromycin S/R 1g once daily April 2004 - Clarithromycin S/R (Klaricid XL) ceased to be abailable and subsequent patients will receive standard Clarithromycin 500mg bd
12042019|NCT00269386|Drug|Placebo|
12042020|NCT00269373|Procedure|PET-CT|no drugs included
12042021|NCT00269360|Procedure|Chiropractic + Supervised Rehabilitative Exercise|"Chiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation.
~Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises."
12042022|NCT00269360|Procedure|Supervised Rehabilitative Exercise|Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
12042023|NCT00269360|Behavioral|Self-care education|Self-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation.
12042024|NCT00269347|Procedure|Chiropractic Spinal Manipulation|
12042025|NCT00269347|Procedure|Exercise|
12042026|NCT00269347|Behavioral|Self-care|
12042027|NCT00269334|Drug|Using Citalopram(drug) or Paroxetine(drug)|
12042028|NCT00269321|Procedure|Chiropractic Manual treatment + home exercise (procedure+behavior)|"The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy.
~Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active."
12042080|NCT00268918|Drug|PTK787|Participants may continue receiving study drug as long as their disease does not worsen
12042309|NCT00267046|Drug|Cisplatin|120 mg/m^2 on day 0, for patients receiving the AP Regimen.
12042029|NCT00269321|Procedure|Supervised rehabilitative exercise+home exercise|"The rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists.
~Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active."
12042030|NCT00269321|Behavioral|Home exercise|Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
12042031|NCT00269308|Procedure|Chiropractic Manual treatment + home exercise ( procedure+behavior)|"The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy.
~Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active"
12042032|NCT00269308|Procedure|Supervised rehabilitative exercise + home exercise|"The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements.
~Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active"
12042033|NCT00269308|Behavioral|Home exercise|Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
12042034|NCT00269295|Biological|Ty800|Live attenuated Ty800 S typhi oral vaccine is co-administered with a sodium bicarbonate buffer solution. Dosages: 5 X 10^7 cfu, 5 X 10^8 cfu, and 5 X 10^9 cfu.
12042035|NCT00269295|Drug|Placebo|150 mL of the prepared sodium bicarbonate buffer solution. Placebo will look and taste essentially like the study product.
12042036|NCT00269282|Behavioral|Self-Management Training|Asthma education and self-monitoring strategies
12042037|NCT00269282|Behavioral|Motivational Interviewing (MI)|Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors.
12042038|NCT00269269|Drug|antihypertensive drug|
12042039|NCT00269269|Behavioral|placebo|
12042040|NCT00269243|Drug|Quinapril|
12042041|NCT00269230|Device|Pacing Lead|Left ventricular pacing lead
12042042|NCT00269217|Drug|niacin (+) laropiprant (+) simvastatin|Duration of Treatment 12 Weeks
12042043|NCT00269217|Drug|Comparator: niacin (+) laropiprant|Duration of Treatment 12 Weeks
12042044|NCT00269217|Drug|Comparator: simvastatin|Duration of Treatment 12 Weeks
12042045|NCT00269204|Drug|niacin (+) laropiprant|Duration of Treatment - 24 weeks
12042046|NCT00269204|Drug|ER-niacin|Duration of Treatment - 24 weeks
12042047|NCT00269191|Drug|MK0663, etoricoxib / Duration of Treatment 12 Weeks|
12042048|NCT00269191|Drug|Placebo or Ibuprofen / Duration of Treatment 12 Weeks|
12042049|NCT00269178|Behavioral|Peer Health Education Programme|
12042050|NCT00269165|Procedure|Balloon Aortic Valvuloplasty|
12042051|NCT00269165|Procedure|External Beam Radiation|
12042052|NCT00269152|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles
12042053|NCT00269152|Drug|cisplatin|75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
12042054|NCT00269152|Drug|carboplatin|area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
12042055|NCT00269139|Behavioral|Crisis resolution|
12042056|NCT00269126|Drug|fluticasone propionate/salmeterol combination DISKUS|
12042057|NCT00269126|Drug|salmeterol xinafoate|
12042058|NCT00269113|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv monthly for 8 cycles
12042059|NCT00269113|Drug|Standard chemotherapy|As prescribed
12042060|NCT00269087|Drug|fluticasone propionate/salmeterol combination DISKUS|
12042061|NCT00269074|Drug|IDEA-070|
12042062|NCT00269061|Drug|pioglitazone|
12042063|NCT00269048|Drug|SB-480848|SB-480848
12042064|NCT00269048|Drug|placebo|placebo
12042065|NCT00269035|Drug|SB773812|SB-773812 tablets will be available with dose strength of 60 mg
12042066|NCT00269035|Drug|Risperidone|Risperidone tablets will be available with dose strength of 3 and 6 mg
12042067|NCT00269022|Drug|SB-705498|
12042068|NCT00269009|Behavioral|CHERL|
12042069|NCT00268996|Drug|SB-480848|SB-480848 is available as enteric-coated, free-base micronized tablet
12042070|NCT00268996|Drug|SB-480848 matching placebo|Placebo is available as enteric-coated, free-base micronized tablet
12042071|NCT00268983|Biological|Tositumomab and Iodine I 131 Tositumomab|"Dosimetric dose: 450 mg Tositumomab infused over 1 hour followed by 5 mCi I 131 Tositumomab infused over 20 minutes
~Therapeutic dose: 450 mg Tositumomab infused over 1 hour followed by Individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes."
12042072|NCT00268983|Biological|Rituximab|Rituximab 375 mg/m2 given as an IV infusion once weekly for four weeks.
12042073|NCT00268970|Drug|Satraplatin in combination with Paclitaxel|Paclitaxel 200 mg/m2 IV over 3 hours on day 1. Satraplatin 60 mg/m2 administered by mouth once daily for 5 consecutive days (days 1-5). Satraplatin will be administered within 2 hours following paclitaxel infusion on day 1. Subsequent doses on days 2-5 will be taken at approximately 24 hour intervals.
12042074|NCT00268957|Drug|Sevelamer carbonate (Renvela®)|sevelamer carbonate powder dosed once per day with largest meal
12042075|NCT00268957|Drug|Sevelamer hydrochloride (Renagel®)|Sevelamer hydrochloride tablets dosed three times a day with meals
12042076|NCT00268944|Biological|Myozyme|20 mg/kg qow
12042202|NCT00268216|Drug|Salmeterol 50mcg/ Fluticasone Propionate 500mcg|
12042081|NCT00268905|Drug|E7389 + carboplatin AUC 5|Patients will receive E7389 before (Schedule A) or after (Schedule B) carboplatin AUC 5 infusion. E7389 will be administered as a 2-5 minute intravenous (IV) bolus infusion at a starting dose of 0.7 mg/m^2 on Days 1 and 8 every 21 days. Carboplatin 5 AUC will be administered as a 30-minute IV infusion on Day 1 every 21 days. Dose escalation will be performed in cohorts of three patients per dose level per schedule.
12042082|NCT00268905|Drug|E7389 + carboplatin AUC 6|"After MTD is reached with carboplatin AUC 5, dose escalation of E7389 in combination with carboplatin at AUC 6 will begin at one dose level below MTD, using the preferred schedule (A or B).
~If carboplatin AUC 6 with E7389 is tolerated, the MTD reached will be used to enroll 20 additional patients with Stage IIIB or IV non-small cell lung cancer (NSCLC). If carboplatin AUC 6 is not tolerated, these patients will be enrolled at the MTD determined with the combination of E7389 and carboplatin AUC 5."
12042083|NCT00268905|Drug|E7389+carboplatin AUC 6|In a population of patients who had generally received multiple prior chemotherapies, the eribulin MTD has been determined to be 1.1 mg/m2 in combination with carboplatin at an AUC of 6. The first-line NSCLC patients in the extension arm may tolerate a higher dose of eribulin, because they have not been exposed to the toxicity of other chemotherapies. To investigate this possibility, the dose of eribulin will be increased to 1.4 mg/m2 for subsequent patients, if the first six of these patients do not experience a DLT during their first cycle of eribulin at 1.1 mg/m2 and carboplatin at AUC 6 combination therapy. If no more than one of the first six patients experience a DLT during the first cycle with the 1.4 mg/m2 dose of eribulin, then the 1.4 mg/m2 dose will be considered the recommended dose for front-line NSCLC therapy and the remaining patients will be treated using this dose.
12042084|NCT00268892|Drug|Degarelix|"Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
~Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study."
12042085|NCT00268892|Drug|Degarelix|"Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
~Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study."
12042086|NCT00268892|Drug|Degarelix|"Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
~Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study."
12042087|NCT00268879|Drug|Renzapride|Placebo Renzapride 4 mg QD Renzapride 2 mg BID
12042088|NCT00268866|Behavioral|Education|
12042089|NCT00268853|Drug|CPOP-R|Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
12042090|NCT00268853|Drug|CHOP-R|Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
12042091|NCT00268840|Drug|Docetaxel|Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
12042092|NCT00268840|Drug|Gemcitabine|Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
12042093|NCT00268827|Drug|Kaletra soft-gel capsules switched to Kaletra tablets|
12042094|NCT00268827|Device|MOS-HIV Health and Medication Satisfaction Survey, Global Conditioning Improvement and Therapy Preference Questionnaire|
12042095|NCT00268814|Drug|Diacetylmorphine|Diacetylmorphine (i.v.), daily
12042096|NCT00268814|Behavioral|Psycho-education and Counselling|Psycho-educational group therapy and individual counselling
12042097|NCT00268814|Drug|Methadone|Methadone (p.o.), daily
12042098|NCT00268814|Behavioral|Case management and Motivational interviewing|Individual Case Management combined with Motivational interviewing
12042099|NCT00268788|Drug|Subcutaneous immunoglobulin|Individually dosed, given twice a week.
12042100|NCT00268788|Drug|Intravenous immunoglobulin|Individual dose and frequency
12042101|NCT00268775|Behavioral|training and follow-up of pharmacists|
12042102|NCT00268775|Behavioral|patient-directed discontinuation letter|
12042103|NCT00268762|Drug|argatroban|Argatroban IV Infusion at 1mcg/kg/min for 48 hours.
12042104|NCT00268749|Drug|glycine|0.8 g/kg/day
12042105|NCT00268723|Drug|Levalbuterol tartrate HFA MDI|levalbuterol MDI 90 mcg QID
12042106|NCT00268723|Drug|Placebo|Placebo MDI QID
12042107|NCT00268710|Drug|docetaxel|
12042108|NCT00268697|Drug|Lapaquistat acetate|Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 24 weeks.
12042109|NCT00268697|Drug|Lapaquistat acetate and ezetimibe|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks.
12042110|NCT00268697|Drug|Ezetimibe|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks.
12042111|NCT00268684|Drug|Erlotinib, Temozolomide|
12042112|NCT00268671|Drug|Docetaxel|
12042113|NCT00268658|Device|SmartStep(tm) biofeedback device|
12042114|NCT00268645|Drug|Insulin Glargine|
12042115|NCT00268632|Drug|risedronate|
12042116|NCT00268619|Drug|Ramipril|
12042117|NCT00268606|Behavioral|cognitive-behavioral therapy|
12042118|NCT00268593|Drug|PI-88|Subcutaneous injection administered 7 days/week for 130 mg PI-88 and 4 days/week for 250 mg PI-88; patients to be treated until progression or withdrawal from study.
12042119|NCT00268593|Drug|docetaxel|Subcutaneous injection administered 7 days/week for 130 mg PI-88 and 4 days/week for 250 mg PI-88; patients to be treated until progression or withdrawal from study.
12042120|NCT00268593|Drug|prednisone|5 mg twice a day orally
12042121|NCT00268580|Behavioral|Asthma Care Pathway|Asthma care provided using standardized asthma care pathway
12042122|NCT00268567|Drug|leflunomide combined with prednisone|
12042123|NCT00268554|Drug|dipyridamole|
12042124|NCT00268554|Drug|caffeine|
12042125|NCT00268541|Behavioral|Physical activity|
12042374|NCT00266253|Drug|GK Activator (2)|Escalating doses, po bid or qd for 12 weeks.
12042126|NCT00268528|Behavioral|Compliance Monitoring|Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
12042127|NCT00268528|Other|Laboratory Biomarker Analysis|Correlative studies
12042128|NCT00268528|Drug|Mercaptopurine|Given PO
12042129|NCT00268528|Drug|Methotrexate|Given PO
12042130|NCT00268528|Other|Questionnaire Administration|Ancillary studies
12042131|NCT00268528|Other|Study of Socioeconomic and Demographic Variables|Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
12042132|NCT00268515|Drug|cyclosporine|
12042133|NCT00268515|Drug|tacrolimus|
12042134|NCT00268515|Drug|prednisone|
12042135|NCT00268515|Drug|azathioprine|
12042136|NCT00268502|Other|study of socioeconomic and demographic variables|
12042137|NCT00268502|Procedure|fatigue assessment and management|
12042138|NCT00268502|Procedure|management of therapy complications|
12042139|NCT00268502|Procedure|psychosocial assessment and care|
12042140|NCT00268502|Procedure|quality-of-life assessment|
12042141|NCT00268489|Biological|bevacizumab|
12042142|NCT00268489|Drug|pemetrexed disodium|
12042143|NCT00268476|Drug|Celecoxib|
12042144|NCT00268476|Drug|Docetaxel|
12042145|NCT00268476|Drug|Prednisolone|
12042146|NCT00268476|Drug|ADT|
12042147|NCT00268476|Drug|Zoledronic Acid|
12042148|NCT00268476|Drug|Abiraterone|
12042149|NCT00268476|Radiation|Radiotherapy to the prostate|
12042150|NCT00268476|Drug|Enzalutamide|
12042151|NCT00268476|Drug|Metformin|
12042152|NCT00268476|Drug|Transdermal Oestradiol|
12042153|NCT00268463|Drug|capecitabine|"Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1
~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles: Arm 2"
12042154|NCT00268463|Drug|floxuridine|Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
12042155|NCT00268463|Drug|oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1
~Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles: Arm 2"
12042156|NCT00268450|Biological|bevacizumab|"Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles
~After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles"
12042157|NCT00268450|Drug|cisplatin|Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles
12042158|NCT00268450|Drug|gemcitabine hydrochloride|Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles
12042159|NCT00268450|Drug|paclitaxel|After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles
12042160|NCT00268450|Procedure|cysectomy|
12042161|NCT00268437|Drug|carboplatin|carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
12042162|NCT00268437|Drug|Pemetrexed|Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
12042163|NCT00268437|Procedure|conventional surgery|
12042164|NCT00268437|Procedure|neoadjuvant therapy|
12042165|NCT00268437|Radiation|radiation therapy|Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
12042166|NCT00268411|Drug|gemcitabine hydrochloride|
12042167|NCT00268411|Drug|oxaliplatin|
12042168|NCT00268398|Drug|oxaliplatin, folinic acid, fluorouracil|folinic acid 200 mg/m² (day 1&2) oxaliplatin 85 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1&2) continuous 5FU 600mg/m² (day 1 to 2)
12042169|NCT00268398|Drug|oxaliplatin, irinotecan, folinic acid, fluorouracil|"FOLFOX7 folinic acid 400 mg/m² (day 1) oxaliplatin 130 mg/m² (day 1) continuous 5FU 3000mg/m² (day 1 to 2)
~FOLFIRI folinic acid 400 mg/m² (day 1) irinotecan 180 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1) continuous 5FU 2400mg/m² (day 1 to 2)"
12042170|NCT00268385|Other|Laboratory Biomarker Analysis|Correlative studies
12042171|NCT00268385|Other|Pharmacological Study|Correlative studies
12042172|NCT00268385|Drug|Temozolomide|Given orally
12042173|NCT00268385|Drug|Vorinostat|Given orally
12042174|NCT00268372|Drug|cisplatin|
12042175|NCT00268372|Drug|docetaxel|
12042176|NCT00268372|Drug|5-fluorouracil|
12042177|NCT00268372|Procedure|surgery|
12042178|NCT00268372|Radiation|radiation therapy|
12042179|NCT00268359|Biological|bevacizumab|
12042180|NCT00268359|Drug|irinotecan hydrochloride|
12042181|NCT00268346|Drug|ZD1839|ZD1839 treatment will be taken once a day PO, every day about the same time
12042182|NCT00268333|Drug|fluorouracil|
12042183|NCT00268333|Drug|leucovorin calcium|
12042184|NCT00268333|Drug|oxaliplatin|
12042185|NCT00268333|Procedure|neoadjuvant therapy|
12042186|NCT00268320|Device|Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator|
12042187|NCT00268307|Drug|Autologous, Unfractionated Bone Marrow Mononuclear Cells|Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.
12042188|NCT00268294|Device|Cardiac Resynchronization Therapy|
12042189|NCT00268281|Device|Left Ventricular Capture Management Software|
12042190|NCT00268255|Drug|gefitinib|
12042191|NCT00268255|Procedure|adjuvant therapy|
12042192|NCT00268255|Procedure|enzyme inhibitor therapy|
12042193|NCT00268255|Procedure|neoadjuvant therapy|
12042194|NCT00268255|Procedure|protein tyrosine kinase inhibitor therapy|
12042195|NCT00268255|Procedure|radiation therapy|
12042196|NCT00268255|Procedure|radiosensitization|
12042197|NCT00268242|Drug|Gemcitabine Hydrochloride|10 mg/m2/ min IV for 12 hours
12042198|NCT00268242|Drug|Mitoxantrone Hydrochloride|12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3
12042199|NCT00268229|Drug|cytarabine|300 mg/m2/day
12042200|NCT00268229|Drug|daunorubicin hydrochloride|45 mg/m2/day
12042201|NCT00268229|Drug|imatinib mesylate|dose escalation (300 mg/day to 800 mg/day).
12042478|NCT00265551|Drug|SCA-136 (200 mg)|
12042203|NCT00268203|Biological|Iodine I 131 Tositumomab Therapeutic Regimen|Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
12042204|NCT00268177|Drug|Salmeterol/fluticasone propionate 50/500mcg Diskus|
12042205|NCT00268164|Drug|lactobacilus acidophilus & bifidobacterium animalis/lactis|
12042206|NCT00268151|Drug|Oxaliplatin|
12042207|NCT00268151|Drug|Capecitabine|
12042208|NCT00268138|Drug|elmex gel|elmex gel once a week
12042209|NCT00268125|Device|Acupression's bracelet|
12042210|NCT00268125|Behavioral|Hygiene and dietetic advices|
12042211|NCT00267969|Drug|ustekinumab|Type = exact number, Form = solution for injection, Number = 45 and 90, Unit = mg, Route = subcutaneous (SC) administered at Weeks 0, 4 and 16. Both treatments (45 mg and 90 mg) administered every 12 weeks after Week 16 depending on clinical response.
12042212|NCT00267969|Drug|placebo|Form = solution for injection, route = SC administered at Weeks 0 and 4. At Weeks 12 and 16, placebo will be crossed over to receive ustekinumab 45 mg or 90 mg.
12042213|NCT00267956|Drug|CNTO 1275 63 mg|The patients will receive 90 mg (or 63 mg after filtration) subcutaneous injection on Weeks 0, 1, 2, and 3; Placebo subcutaneous injection on Weeks 12 and 16.
12042214|NCT00267956|Drug|Placebo|The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CNTo1275 90 mg (or 63 mg after filtration) subcutaneous injection
12042215|NCT00267943|Drug|telmisartan 80 mg + hydrochlorothiazide 25 mg|
12042216|NCT00267930|Drug|Vernakalant (oral)|
12042217|NCT00267930|Drug|Placebo comparator|
12042218|NCT00267917|Device|Berodual Respimat|
12042219|NCT00267917|Device|Berodual HFA-MDI|
12042220|NCT00267904|Other|Food-Coffee|Caffeinated coffee and decaffeinated coffee ingestion
12042221|NCT00267904|Other|Food-Banana|Banana ingestion
12042222|NCT00267904|Other|Food-Olive|Olives ingestion
12042223|NCT00267904|Other|Temp. Manip.|Manipulate temperature at skin of the back
12042224|NCT00267865|Drug|Methotrexate|6000 mg/m^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
12042225|NCT00267865|Drug|Rituximab|375 mg/m^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
12042226|NCT00267865|Drug|Leucovorin|Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
12042227|NCT00267852|Other|as clinical practice|Dosage, form, frequency and duration as per ordinary clinical practice
12042228|NCT00267839|Behavioral|physical exercise, wellness|
12042229|NCT00267826|Drug|Rituximab|Intravenous infusion of 1000mg Rituximab (anti-CD20) on days 1 and 15 to patients with atopic dermatitis
12042230|NCT00267813|Drug|Bupropion (Zyban)|1 tablet a day increasing to 2 tablets a day after a week
12042231|NCT00267787|Other|genetic analysis|standard of care
12042232|NCT00267774|Device|Fractional flow reserve|
12042233|NCT00267774|Procedure|Angio-guided PCI|
12042234|NCT00267748|Drug|Sunitinib Malate Continuous Daily Dosing|Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
12042235|NCT00267748|Drug|Sunitinib Malate Schedule 4/2|Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
12042236|NCT00267735|Behavioral|Use of Computerized Decision Aid on Childbirth|
12042237|NCT00267722|Drug|Visilizumab|
12042238|NCT00267709|Drug|Visilizumab|
12042239|NCT00267696|Drug|Bevacizumab|Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
12042240|NCT00267696|Drug|Gemcitabine|A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
12042241|NCT00267696|Drug|Carboplatin|
12042242|NCT00267683|Drug|insulin aspart|
12042243|NCT00267683|Drug|glibenclamide|
12042244|NCT00267670|Drug|Pentoxifylline|400mg PO TID
12042245|NCT00267670|Drug|Placebo|1 pill PO TID
12042246|NCT00267657|Drug|Reserpine|
12042247|NCT00267618|Behavioral|FHP Pain|Evidence-based psychological and behavioural Intervention
12042248|NCT00267605|Behavioral|FHPADHD|Evidence-based psychological and behavioural distance intervention
12042249|NCT00267605|Behavioral|ADHD Standard Care|
12042250|NCT00267592|Drug|Talampanel|Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.
12042251|NCT00267592|Radiation|Radiation Therapy (RT) 5 days a week +|
12042252|NCT00267592|Drug|temozolomide(TMZ) 75mg|temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
12042253|NCT00267592|Drug|adjuvant TMZ 200mg|adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.
12042254|NCT00267579|Behavioral|Strongest Families (formerly Family Help Program): Behaviour Disorder Program|Evidence-based psychological and behavioural Distance Intervention
12042255|NCT00267566|Behavioral|Strongest Families (formerly Family Help Program): Anxiety Program|Evidence-based psychological and behavioural distance intervention
12042256|NCT00267553|Drug|Atamestane|
12042257|NCT00267553|Drug|toremifene|
12042258|NCT00267553|Drug|letrozole|
12042259|NCT00267540|Behavioral|cholecalciferol (D3) (vitamin)|
12042260|NCT00267527|Drug|CJC 1295|
12042261|NCT00267514|Drug|sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)|sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
12042262|NCT00267514|Drug|sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)|sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
12042263|NCT00267488|Drug|topotecan|
12042264|NCT00267449|Device|SoftScan Optical Breast Imaging System|
12042265|NCT00267436|Behavioral|Community PROMISE|The Community PROMISE begins with a community assessment to identify HIV risk factors. Once risk factors have been identified, individuals from the targeted at-risk community are recruited and trained to be peer advocates. Trained peer advocates interview members of the community about their behavior. Role model stories are written based on the interviews. Role model stories are personal accounts from individuals in the target population which explain how and why they took steps to practice HIV risk-reduction behaviors and the positive effects the choice has had on their lives. Each week, peer advocates distribute role model stories and supplies, such as condoms, to 10 to 20 members of their social networks.
12042266|NCT00267410|Behavioral|Healthy Relationships|"Healthy Relationships, grounded in the social cognitive theory, is a five-session, group-level intervention originally designed for HIV-positive heterosexual individuals seeking skills-building and support around risk reduction, as well as disclosure of status and sexual preference. Through clip media and active role-plays, the intervention promotes the development of decision-making and problem-solving tools, empowering participants to make voluntary and informed decisions around disclosure and safer sex practices. This model was formally disseminated to AIDS Service Organizations as part of CDC's strategic plan - Advancing HIV Prevention, New Strategies for a Changing Epidemic - which focused on innovative strategies to recruit individuals into HIV testing, as well as a movement towards secondary prevention efforts."
12042267|NCT00267384|Drug|Oral N-Acetylcysteine|
12042268|NCT00267371|Device|PFO Closure with Premere investigational device.|PFO Closure with Premere investigational device.
12042269|NCT00267371|Drug|Medical management/current medications per standard of care by personal physician.|Medical management with current medications per standard of care by personal physician.
12042270|NCT00267358|Drug|RC-1291 HCl|
12042271|NCT00267358|Drug|Placebo|
12042272|NCT00267332|Drug|Modafinil|
12042273|NCT00267319|Drug|Glatiramer acetate|
12042274|NCT00267306|Drug|Visilizumab|
12042275|NCT00267293|Drug|Acetaminophen|Given for fever control 15mg/kg
12042276|NCT00267293|Drug|Ibuprofen|Given for fever control 10 mg/kg
12042277|NCT00267280|Drug|torcetrapib/atorvastatin|
12042278|NCT00267280|Drug|simvastatin|
12042279|NCT00267267|Drug|torcetrapib/atorvastatin|
12042280|NCT00267267|Drug|ezetimibe/simvastatin|
12042281|NCT00267254|Drug|torcetrapib/atorvastatin|
12042282|NCT00267254|Drug|simvastatin|
12042283|NCT00267241|Other|Mechanical Ventilation|Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)
12042284|NCT00267215|Drug|Lumiracoxib|
12042285|NCT00267202|Drug|Placebo|Doses of placebo were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.
12042286|NCT00267202|Drug|Omalizumab|Doses of omalizumab were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.
12042287|NCT00267202|Drug|Immunotherapy|"Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or maintenance solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours."
12042288|NCT00267202|Drug|Immunotherapy|"Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or maintenance solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours."
12042289|NCT00267189|Drug|Everolimus|1.5 mg bid adjusted in order to achieve a trough level between 3 and 8 ng/mL while in combination with CNI and between 6 and 12 ng/mL after CNI discontinuation
12042290|NCT00267189|Drug|Calcineurin inhibitors (CNI)|
12042291|NCT00267189|Drug|Mycophenolate acid (MPA)/ Azathioprine (AZA)|
12042292|NCT00267189|Drug|Steroids|
12042293|NCT00267176|Drug|lumiracoxib|
12042294|NCT00267163|Drug|donepezil|
12042295|NCT00267163|Drug|Placebo|
12042296|NCT00267150|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|Experimental
12042297|NCT00267137|Device|Pacing Algorithms|
12042298|NCT00267111|Drug|Eucerin plus|1g, single application
12042299|NCT00267111|Drug|Amethocaine gel 4%|1 g, single application
12042300|NCT00267098|Device|Cardiac Resynchronization Therapy (CRT)|Biventricular pacing
12042301|NCT00267098|Device|Cardiac Resynchronization Therapy (CRT)|Right ventricular pacing
12042302|NCT00267085|Biological|Synthetic Tumor-Specific Breakpoint Peptide Vaccine|CML vaccine, Imatinib mesylate, subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months
12042303|NCT00267059|Drug|Lenalidomide|10 mg/day, orally once a day for 28 days
12042304|NCT00267046|Drug|Palifermin|180 mcg/kg 3 days prior to chemotherapy
12042305|NCT00267046|Drug|Placebo|Single dose 3 days prior to chemotherapy
12042306|NCT00267046|Drug|Adriamycin (Doxorubicin)|30 mg/m^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
12042307|NCT00267046|Drug|Ifosfamide|2.5 g/m^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m^2); for patients receiving the AI Regimen.
12042479|NCT00265551|Drug|SCA-136 (400 mg)|
12042310|NCT00267033|Procedure|injection of orthopaedic cement into vertebral bodies|injection of orthopaedic cement into vertebral bodies
12042311|NCT00267020|Drug|enzastaurin|1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles
12042312|NCT00267020|Drug|gemcitabine|1000 milligrams/square meter (mg/m^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles
12042313|NCT00267007|Drug|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (IV or SC)
12042314|NCT00267007|Drug|Placebo|Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)
12042315|NCT00266981|Device|APOS - exercise component|
12042316|NCT00266929|Procedure|surgical|surgical treatment of odontoid fractures
12042317|NCT00266929|Procedure|conservative treatment|conservative stabilization of fractures
12042318|NCT00266877|Drug|HKI-272|320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.
12042319|NCT00266864|Drug|Testosterone Transdermal System (Androderm 5 mg patch)|Testosterone Transdermal System (Androderm 5 mg patch)
12042320|NCT00266851|Drug|Azithromycin|600 mg x 3 days, then 600 mg weekly x 11 weeks
12042321|NCT00266851|Drug|Placebo|Matching placebo
12042322|NCT00266838|Drug|Maxidex; Lacrystat|6 times daily, for 20 weeks.
12042323|NCT00266825|Drug|DHA|600 mg DHA
12042324|NCT00266825|Other|Placebo capsule|Placebo capsule
12042325|NCT00266812|Drug|Temozolomide and radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
12042326|NCT00266812|Procedure|Whole brain radiotherapy|2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
12042327|NCT00266799|Drug|Pegylated liposomal doxorubicin (SCH 200746)|pegylated liposomal doxorubicin (50 mg/m^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity
12042328|NCT00266799|Drug|Capecitabine|capecitabine (1250 mg/m^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity
12042329|NCT00266786|Drug|Intranasal Ketorolac Tromethamine|Intranasal at 30mg
12042330|NCT00266786|Drug|Intranasal Placebo|Intranasal Placebo
12042331|NCT00266773|Behavioral|Chronic pain therapeutic interactive voice response (TIVR) system|Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls
12042332|NCT00266747|Drug|SR58611A|
12042333|NCT00266734|Device|RPS Adeno Detector|
12042334|NCT00266721|Drug|Pancrelipase (Creon) 2 tablets with each meal|
12042335|NCT00266708|Drug|Risedronate|risedronate 35 mg weekly
12042336|NCT00266708|Drug|Placebo|Risedronate Placebo 35 mg weekly
12042337|NCT00266695|Drug|Ruboxistaurin|32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.
12042338|NCT00266682|Device|Pacing Lead|
12042339|NCT00266669|Drug|Topical organogel with nitroglycerin|
12042340|NCT00266656|Drug|Humatrope|According to investigator's clinical practice and guided by the approved package insert
12042341|NCT00266643|Drug|duloxetine hydrochloride|
12042342|NCT00266630|Drug|olanzapine|oral, daily
12042343|NCT00266630|Drug|lithium|Dose adjusted according to local package insert
12042344|NCT00266630|Drug|valproate|Dose adjusted according to local package insert
12042345|NCT00266630|Drug|carbamazepine|Dose adjusted according to local package insert
12042346|NCT00266617|Drug|epoetin alfa|
12042347|NCT00266604|Drug|Topiramate|
12042348|NCT00266591|Drug|topiramate|
12042349|NCT00266578|Drug|Fluticasone Propionate|Flovent vs. placebo daily for 3 months
12042350|NCT00266565|Drug|Mepolizumab|10mg/kg (max 750 ml) once a month for 3 months
12042351|NCT00266552|Drug|risperidone|
12042352|NCT00266539|Drug|E-TRANS Fentanyl hydrochloride; Morphine|
12042353|NCT00266526|Biological|Recombinant birch pollen|
12042354|NCT00266487|Drug|Folic acid|
12042355|NCT00266487|Drug|Vitamin B12|
12042356|NCT00266487|Drug|Vitamin B6|
12042357|NCT00266474|Other|Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.|
12042358|NCT00266461|Drug|Daikenchuto Extract Granules (TU-100)|
12042359|NCT00266448|Drug|Chlorhexidine solution 4%|
12042360|NCT00266409|Drug|Niravam|
12042361|NCT00266409|Drug|SSRI/SNRI|Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
12042362|NCT00266396|Behavioral|Recommend full weight-bearing|The full weight-bearing group is trained in 4-point gait with crutches and is recommended to put as much weight as tolerated on the leg on which surgery has been performed, immediately after surgery
12042363|NCT00266396|Behavioral|Recommend parital weight-bearing|The partial weight-bearing group is trained in 3-point gait with crutches and is instructed to limit weight-bearing of the affected leg to 20kg for a period of six-weeks. Scales are used to train these participants not to exceed 20kg
12042364|NCT00266357|Drug|MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)|
12042365|NCT00266357|Drug|Placebo / Duration of Treatment: 2 days for screening period|
12042366|NCT00266344|Drug|MK0928, gaboxadol / Duration of Treatment 3 Weeks|
12042367|NCT00266344|Drug|Placebo / Duration of Treatment 3 Weeks|
12042368|NCT00266331|Drug|Reduced glutathione|
12042369|NCT00266318|Drug|Interferon Alfacon-1 and Ribavirin|
12042370|NCT00266305|Behavioral|Fish oil (Dry n-3, BASF)|5 g/oil daily for the first four month of lactation
12042371|NCT00266292|Behavioral|Fish oil (Bio-Marine, Pharma Nord)|
12042372|NCT00266292|Behavioral|n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)|
12042373|NCT00266279|Drug|Oxaliplatin, Capecitabine|"Agent, DOSE AND SCHEDULE (28-days cycle):
~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
12042480|NCT00265551|Drug|olanzapine (15 mg)|
12042375|NCT00266253|Drug|Metformin|As prescribed, for 12 weeks
12042376|NCT00266240|Drug|GK Activator (2)|Escalating doses po bid
12042377|NCT00266240|Drug|Placebo|po bid
12042378|NCT00266227|Drug|placebo|Intravenous repeating dose
12042379|NCT00266227|Drug|rituximab|Intravenous repeating dose
12042380|NCT00266227|Drug|methotrexate|Oral or parenteral repeating dose
12042381|NCT00266227|Drug|folate|Intravenous repeating dose
12042382|NCT00266214|Drug|lidocaine patch 5%|1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime
12042383|NCT00266162|Drug|Bosentan administration|
12042384|NCT00266149|Drug|Oral contraception|
12042385|NCT00266149|Drug|Lamotrigine|
12042386|NCT00266136|Drug|Cytarabine|see protocol
12042387|NCT00266136|Drug|Thioguanine|see protocol
12042388|NCT00266136|Drug|Daunorubicin|see protocol
12042389|NCT00266136|Drug|Cyclophosphamide|see protocol
12042390|NCT00266136|Drug|G-CSF|see protocol
12042391|NCT00266136|Procedure|Autologous stem cell transplantation|for details see protocol
12042392|NCT00266136|Procedure|Allogeneic stem cell transplantation|for details see protocol
12042393|NCT00266123|Drug|Sirolimus|
12042394|NCT00266110|Biological|sargramostim|All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.
12042395|NCT00266110|Biological|therapeutic autologous dendritic cells|patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.
12042396|NCT00266110|Biological|trastuzumab|Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration. If the subject has previously received Trastuzumab within 30 days and has no adverse history with the drug, the infusion will be given over 30 minutes. If the subject is currently receiving Trastuzumab, the first study infusion will be given at 4mg/kg over 30 minutes. Subsequently, Trastuzumab will be infused at 4 mg/kg in the side-port of a freely flowing IV over 30 minutes.
12042397|NCT00266110|Drug|vinorelbine ditartrate|Vinorelbine 25 mg/m2 will be administered IV over six to ten minutes into the side port of a freely flowing IV line.
12042398|NCT00266097|Drug|erlotinib hydrochloride|Cohort (-1) = 50 mg daily Cohort 1 = 50mg daily Cohort 2= 75 mg daily Cohort 3 = 100mg daily Cohort 4 = 100mg daily Cohort 5 = 150mg daily
12042399|NCT00266097|Drug|gemcitabine hydrochloride|Gemcitabine will be given at a dose of 100 mg/m2 for the first cohort and escalated to a fixed dose of 200 mg/m2 for the remaining 3 cohorts
12042400|NCT00266097|Drug|oxaliplatin|Oxaliplatin will be given at 30 mg/m2 weekly for the first two cohorts and then will be dose-escalated to 45 mg/m2 and 60 mg/m2 for the next 2 in cohorts
12042401|NCT00266097|Radiation|radiation therapy|5040 cGy, every week, up to 6 weeks
12042402|NCT00266097|Drug|gemcitabine hydrochloride|Given weekly at a starting dose of 100mg/m2 in the first 3 cohorts and dose escalated to 200 mg/m2 for the remaining 2 cohorts
12042403|NCT00266097|Drug|Oxaliplatin|The Part II dose of oxaliplatin will be determined by Part I of the study. The dose for Part II will be one dose level increase from the MTD determined in Part I.
12042404|NCT00266071|Behavioral|Cutaneous response|
12042405|NCT00266058|Drug|Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine|participants receive a total of 6 doses of artemether(80mg)/lumefantrine(480mg)for baseline PK evaluation. This is followed by a 26-day course of either efavirenz(600mg) once daily or lopinavir/ritonavir (400mg/100mg) twice daily and additional 6 doses of artemether/lumefantrine to determine the pharmacokinetics of the antimalarial medications in the context of antiretrovirals. The participants undergo at least a 14 day washout period (between the last baseline PK blood draw and the initiation of antiretrovirals)
12042406|NCT00266032|Drug|Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
12042407|NCT00266032|Drug|Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
12042408|NCT00266032|Drug|Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
12042409|NCT00266019|Behavioral|Weight Management (diet, exercise, and behavior modification)|
12042410|NCT00266006|Drug|eptacog alfa (activated)|
12042411|NCT00265993|Drug|enoxaparin|"All patients will be treated with enoxaparin 1.5 mg/kg, once a day, subcutaneously for up to 10 days.
~Long-term oral anticoagulation will be started in all patients after 24 hours of initiation of enoxaparin treatment and continued at least for 3 months."
12042412|NCT00265980|Drug|Subcutaneous Placebo|Twice daily injections of saline in the same volume as will be used for leptin injections.
12042413|NCT00265980|Drug|Leptin|Leptin will be given as twice daily subcutaneous injections in doses titrated to replicate 8 a.m. circulating leptin concentrations measured in the same subjects prior to weight loss.
12042414|NCT00265967|Drug|Irbesartan|Irbesartan 150-300 mg/d for 8 weeks
12042415|NCT00265954|Behavioral|internet, in-person and internet+in-person|All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.
12042416|NCT00265941|Drug|cetuximab|Cetuximab 400 mg/m^2 IV loading dose 5-7 days before start of radiation therapy, then 250 mg/m^2 IV weekly for 7 weeks
12042417|NCT00265941|Drug|cisplatin|Cisplatin 100 mg/m^2 IV on days 1 and 22
12042418|NCT00265941|Radiation|Accelerated Fractionation by Concomitant Boost|3DCRT 54 Gy in 30 1.8 Gy fractions over 6 weeks with boost 18 Gy in 12 1.5 Gy fractions for last 12 days, for a total of 72 Gy in 42 fractions over 6 weeks
12042419|NCT00265941|Radiation|Intensity-modulated radiation therapy|70 Gy in 35 2.0 Gy fractions over 6 weeks with 6 fractions per week (on Saturday or as second daily fraction) in 5 of the 6 weeks.
12042420|NCT00265928|Drug|bortezomib|
12042421|NCT00265928|Drug|rituximab|
12042422|NCT00265928|Procedure|antibody therapy|
12042423|NCT00265928|Procedure|biological therapy|
12042424|NCT00265928|Procedure|enzyme inhibitor therapy|
12042425|NCT00265928|Procedure|monoclonal antibody therapy|
12042426|NCT00265915|Biological|rituximab|
12042427|NCT00265915|Biological|sargramostim|
12042428|NCT00265902|Procedure|diagnostic imaging|
12042429|NCT00265889|Biological|filgrastim|480 mcg beginning day +5
12042430|NCT00265889|Drug|busulfan|11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
12042431|NCT00265889|Drug|cyclophosphamide|60 mg/kg IV over 2 hours x 2 days
12042432|NCT00265889|Drug|etoposide|60 mg/kg, IV
12042433|NCT00265889|Drug|melphalan|150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
12042434|NCT00265889|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|autologous-autologous tandem hematopoietic stem cell transplantation
12042435|NCT00265889|Radiation|radiation therapy|radiation therapy
12042436|NCT00265876|Drug|AZD0530|Taken daily every 4 weeks
12042437|NCT00265876|Drug|gemcitabine hydrochloride|1000mg/m2 IV weekly
12042438|NCT00265863|Drug|mitomycin C|Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
12042439|NCT00265850|Biological|bevacizumab|Given IV
12042440|NCT00265850|Biological|cetuximab|Given IV
12042441|NCT00265850|Drug|FOLFOX or|Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
12042442|NCT00265850|Drug|FOLFIRI|Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.
12042443|NCT00265837|Biological|graft versus host disease prophylaxis/therapy|
12042444|NCT00265837|Procedure|allogeneic bone marrow transplantation|
12042445|NCT00265837|Procedure|in vitro-treated bone marrow transplantation|
12042446|NCT00265824|Drug|bevacizumab|bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
12042447|NCT00265824|Drug|bevacizumab, erlotinib|bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
12042448|NCT00265811|Drug|Folfox|
12042449|NCT00265811|Drug|Cetuximab|
12042450|NCT00265798|Drug|Sorafenib Tosylate|
12042451|NCT00265785|Drug|pemetrexed|Pemetrexed 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
12042452|NCT00265772|Drug|MODULEN IBD (R) (specific Enteral Nutrition)|
12042453|NCT00265772|Drug|prednisolon|
12042454|NCT00265759|Drug|anastrozole|Given PO
12042455|NCT00265759|Drug|exemestane|Given PO
12042456|NCT00265759|Drug|letrozole|Given PO
12042457|NCT00265759|Procedure|Therapeutic Conventional Surgery|Undergo partial or radical mastectomy or lumpectomy with or without lymph node dissection
12042458|NCT00265746|Drug|Metformin|
12042459|NCT00265746|Behavioral|Lifestyle intervention - diet, physical activity|
12042460|NCT00265733|Drug|capecitabine|
12042461|NCT00265733|Drug|paclitaxel poliglumex|
12042462|NCT00265720|Other|Control|Written materials only
12042463|NCT00265720|Other|Reduced out of pocket expense|Reimbursed up to $500 out of pocket expense for CRC screening
12042464|NCT00265720|Behavioral|one on one education|one on one education with a health educator
12042465|NCT00265720|Behavioral|Group education|Education in a small group
12042466|NCT00265707|Device|Blood pressure measurement|
12042467|NCT00265694|Drug|vinorelbine, gemcitabine and carboplatin|
12042468|NCT00265681|Behavioral|Phone counseling and written materials|
12042469|NCT00265655|Drug|Satraplatin|Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.
12042470|NCT00265642|Drug|Irbesartan|one tablet of 150 mg/d during 2 years
12042471|NCT00265642|Drug|placebo|one tablet per day during 2 years
12042472|NCT00265629|Device|RF catheter ablation|RF ablation using mesh device
12042473|NCT00265616|Drug|propofol|liquid, mg/kg.h, titrated after EEG
12042474|NCT00265616|Drug|thiopental/pentobarbital|liquid, mg/kg.h, titrated after EEG
12042475|NCT00265603|Procedure|Extracorporeal Photochemotherapy With Transimmunization|The photopheresis apparatus and procedure will be identical to that currently used. Patients will receive intravenous 8-MOP (UVADEX®) directly into the photopheresis apparatus, to yield a concentration of 50-200 ng/ml of drug. The blood will be leukapheresed to obtain a buffy coat and will then be passed through the contiguous closed circuit ultraviolet A exposure device, delivering the desired 1-2 joules/cm2 of ultraviolet A energy. In this manner 2-4 molecules of 8-MOP will be induced to bind covalently to thymines of the leukocyte DNA. At that point, the single variation from the standard treatment will be initiated. Instead of returning the patient's cells and the saline to the patient, the bag will be detached from the apparatus. KLH (depyrogenated, endotoxin-free; Calbiochem-Novabiochem Corp., San Diego, CA) will be added at a concentration of 10 g/ml to the DC-rich leukocyte culture prior to overnight culture.
12042476|NCT00265564|Behavioral|Modified Seeking Safety integrated into std outpatient SUD care|The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
12042477|NCT00265564|Behavioral|Standard outpatient SUD care|"Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence."
12042482|NCT00265538|Behavioral|Patient educational letter to engage provider in hypertension rx discussion|Patients will receive a customized/tailored letter (education) including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s). All the intervention arms (A, B and C) receive the letter.
12042483|NCT00265538|Behavioral|Financial incentive (Arms B and C) and health educator phone call (Arm C)|Patients may receive a financial incentive for discussing the intervention letter with their provider and 6 months copay reimbursement and/or the financial incentive discussion incentive, 6 months copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care appt. The Financial incentive is part of both Arms B and C. The health educator phone call is only in Arm C.
12042484|NCT00265525|Behavioral|CardioFit|CardioFit is a 26-week tailored web-based physical activity coaching service for individuals with Coronary Artery Disease (CAD). It has been designed to help patients develop personalized exercise programs based on their medical history, personal goals and preferences. Access to Cardio-fit is through a secured website. The cardio-fit website contains physical activity advice and heart health educational information. Each patient is assigned an on-line coach, whose role is to assist in creating safe an effective physical activity program, and to answer any questions that patients may have throughout the program.
12042485|NCT00265512|Behavioral|Telephone Case Monitoring|Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
12042486|NCT00265512|Behavioral|Continuing Care as Usual|Continuing Care as Usual will include standard group outpatient SUD treatment.
12042487|NCT00265499|Procedure|Skeletonization of the internal thoracic artery|
12042488|NCT00265486|Drug|Recombinant human Erythropoietin|Adm 100 U/kg sc 1 hour before completing exercise in protocol
12042489|NCT00265473|Biological|Allogeneic Islets of Langerhans|Intraportal infusion of islets of Langerhans
12042490|NCT00265460|Drug|Oliwer Twist smokeless tobacco (tobacco)|
12042491|NCT00265447|Behavioral|Strength training|3 months of strength training
12042492|NCT00265447|Behavioral|Aerobic conditioning|3 months of aerobic conditioning
12042493|NCT00265447|Behavioral|Delayed exercise|delayed exercise control group
12042494|NCT00265434|Drug|Pulmozyme|
12042495|NCT00265421|Procedure|Suture technique for perineal repair after delivery|
12042496|NCT00265408|Drug|aspirin|
12042497|NCT00265408|Drug|warfarin|
12042498|NCT00265395|Drug|Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)|"Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks"
12042499|NCT00265395|Drug|Combination of pegylated interferon alfa-2b and ribavirin|"Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks.
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks"
12042500|NCT00265382|Drug|Ziprasidone oral capsules|Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.
12042501|NCT00265369|Drug|Spores of Bacillus Clausii Probiotic Strain|
12042502|NCT00265356|Procedure|PET diagnostic imaging|PET diagnostic imaging
12042503|NCT00265343|Drug|asenapine|5-10 mg sublingually twice daily for 26 weeks
12042504|NCT00265343|Drug|olanzapine|5-20 mg by mouth once daily for 26 weeks
12042505|NCT00265330|Drug|Ziprasidone oral capsules|Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .
12042506|NCT00265317|Drug|erlotinib|erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
12042507|NCT00265317|Drug|sunitinib|Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
12042508|NCT00265317|Drug|erlotinib|erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
12042509|NCT00265317|Drug|placebo|Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
12042510|NCT00265304|Drug|Ketoprofen|
12042511|NCT00265291|Drug|fluoxetine or desipramine|fluoxetine 5-40 mg/day desipramine 50-150 mg/day
12042512|NCT00265278|Drug|Modafinil|
12042513|NCT00265265|Drug|Atomoxetine|
12042514|NCT00265252|Drug|Alendronate|
12042515|NCT00265239|Drug|edaravone|intravenous administration of 30mg Edaravone just before reperfusion therapy
12042516|NCT00265226|Biological|Intra-dermal administration of Mycobacterium w|Mw Vaccine is given as oral suspension. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks
12042517|NCT00265200|Drug|zoledronic acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
12042518|NCT00265148|Drug|Rosiglitazone|Extended Release Tablets
12042519|NCT00265148|Other|Placebo|Placebo dummy to match
12042520|NCT00265135|Drug|CNTO 328|Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.
12042521|NCT00265122|Drug|Ustekinumab 90 mg|one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
12042522|NCT00265122|Drug|Ustekinumab 4.5 mg/kg|one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
12042523|NCT00265122|Drug|Placebo SC|one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)
12042524|NCT00265122|Drug|Placebo IV|one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1
12042525|NCT00265109|Drug|Levetiracetam|The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
12042526|NCT00265096|Biological|golimumab|50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
12042527|NCT00265096|Biological|Placebo; golimumab|SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
12042528|NCT00265096|Biological|golimumab|100 mg sc injections every 4 wks from wk 0 up to 5 yrs
12042529|NCT00265083|Biological|golimumab|100 mg sc injections every 4 wks from wk 0 up to 5 yrs
12042530|NCT00265083|Biological|Golimumab (CNTO 148); placebo|SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg
12042531|NCT00265083|Biological|golimumab|50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
12042532|NCT00265070|Drug|Gefitinib|250 mg tablet oral daily dose
12042533|NCT00265057|Drug|ADH -1 (Exherin™)|
12042534|NCT00265044|Behavioral|Provider Education|
12042535|NCT00265044|Behavioral|Hypertension Alert|
12042536|NCT00265044|Behavioral|Patient Education|
12042537|NCT00265031|Drug|Cyclophosphamide|
12042538|NCT00265031|Drug|Adriamycin|
12042539|NCT00265031|Drug|Etoposide|
12042540|NCT00265031|Drug|Procarbazine|
12042541|NCT00265031|Drug|Prednisone|
12042542|NCT00265031|Drug|Vincristine|
12042543|NCT00265031|Drug|Bleomycin|
12042544|NCT00265031|Procedure|radiation therapy|
12042545|NCT00265018|Drug|Adriamycin|
12042546|NCT00265018|Drug|Bleomycin|
12042547|NCT00265018|Drug|Vinblastine|
12042548|NCT00265018|Drug|DTIC|
12042549|NCT00265018|Radiation|30 Gy IF-RT|
12042550|NCT00265018|Radiation|20 Gy IF-RT|
12042551|NCT00265005|Drug|alteplase|Iv administration of 1 mg/ml up to two times and 2 mg/ml if needed.
12042552|NCT00264979|Procedure|Simultaneous surgery|Simultaneous surgery of colorectal cancer and synchronous liver metastases
12042553|NCT00264979|Procedure|Sequential surgery|Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.
12042554|NCT00264966|Drug|ASM8|
12042555|NCT00264953|Drug|Adriamycin|
12042556|NCT00264953|Drug|Bleomycin|
12042557|NCT00264953|Drug|Vinblastine|
12042558|NCT00264953|Drug|DTIC|
12042559|NCT00264953|Drug|Etoposide|
12042560|NCT00264953|Drug|Procarbazine|
12042561|NCT00264953|Drug|Prednisone|
12042562|NCT00264953|Drug|Vincristine|
12042563|NCT00264953|Radiation|radiation therapy|20 or 30Gy IF-RT
12042564|NCT00264927|Drug|SR121463B|
12042565|NCT00264914|Drug|SR121463B|
12042566|NCT00264901|Drug|insulin detemir|
12042567|NCT00264888|Drug|PTC124|
12042568|NCT00264875|Drug|pregabalin|75mg BID, titrated up to 300mg according to individual response and tolerability
12042569|NCT00264862|Procedure|DynaCT|
12042570|NCT00264849|Drug|Omalizumab|Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.
12042571|NCT00264849|Other|Optimized asthma therapy|Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
12042572|NCT00264823|Behavioral|Use of Memory Aids to take medications|Experimental participants will receive an integrated intervention tailored to the communication and comprehension of the individual, and will include memory aid devices, education regarding side effects and other treatment aspects, and active community outreach. For those who fail to adhere using the basic intervention, a treatment cascade that increases in intensity will be implemented. Using 80% adherence as a target, the cascade will include involvement of family and significant others in prompting participants through use of beepers, cellphones, and for those who still fall short of 80% adherence, directly observed therapy.
12042573|NCT00264810|Procedure|RNS® System implantation|Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.
12042574|NCT00264810|Device|RNS® System responsive stimulation|The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
12042690|NCT00263783|Drug|MEDI-522|MEDI-522 will be administered at doses of 1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg. [As a 30 minute IV infusion initially as a single dose (single-dose treatment period) and 2 to 5 weeks later as weekly doses (multiple-dose treatment period) for up to 1 year.]
12042575|NCT00264797|Drug|Methylphenidate (OROS-MPH)|Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
12042576|NCT00264797|Drug|Methylphenidate (OROS-MPH) - Placebo|Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
12042577|NCT00264758|Device|Conventional hemodialysis|Three times per week in-center hemodialysis
12042578|NCT00264758|Device|Frequent hemodialysis|Six times per week in-center hemodialysis
12042579|NCT00264745|Behavioral|TASK intervention|The Telephone Assessment and Skill-building Kit (TASK) is an individualized 8-week intervention program geared toward reducing depression and improving general health in stroke caregivers.
12042580|NCT00264745|Behavioral|Attention Control|Minimal intervention beyond initial hospital visit.
12042581|NCT00264732|Drug|Amolimogene|1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.
12042582|NCT00264732|Drug|Amolimogene|3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.
12042583|NCT00264732|Other|Placebo|Placebo Group: Two IM placebo injections at Treatment Initiation (1 injection in each quadriceps). Single placebo injections at Weeks 3 and 6 in alternating quadriceps. Each placebo injection consists of approximately 1 mL 0.9% sterile saline.
12042584|NCT00264719|Drug|Metoclopramide (Maxolon)|Mothers will be given metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10 and once a day from 11th to 12th day
12042585|NCT00264719|Drug|placebo|placebo 10 mg
12042586|NCT00264706|Drug|Nona-L-arginine|
12042587|NCT00264680|Drug|lamotrigine|
12042588|NCT00264680|Drug|valproic acid|
12042589|NCT00264667|Drug|GW677954|
12042590|NCT00264654|Drug|BRL29060A|
12042591|NCT00264654|Drug|paroxetine hydrochloride hydrate|
12042592|NCT00264641|Drug|Human insulin|Hyperinsulinaemic induced hypoglycaemia
12042593|NCT00264628|Drug|GW679769|
12042594|NCT00264615|Drug|lamotrigine extended-release|
12042595|NCT00264602|Drug|Near Infrared Imaging|Dye injected into or around tumor at the time of surgery
12042596|NCT00264589|Behavioral|8 weeks individualized training program|no drugs added
12042597|NCT00264576|Biological|Influenza Virus Vaccine|
12042598|NCT00264563|Behavioral|Increasing the level of awareness to Iatrogenesis|Increasing the level of awareness to Iatrogenesis
12042599|NCT00264563|Behavioral|Increasing awareness .|Increasing awareness to Iatrogenesis and active daily recordings
12042600|NCT00264550|Drug|Golimumab 100 mg|Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.
12042601|NCT00264550|Drug|Golimumab 50 mg|Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.
12042602|NCT00264550|Drug|Methotrexate|Participants will receive methotrexate capsules weekly.
12042603|NCT00264550|Drug|Placebo injection|Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.
12042604|NCT00264550|Drug|Placebo capsules|Participants will receive placebo capsules weekly
12042605|NCT00264537|Drug|Placebo injections|SC injections
12042606|NCT00264537|Drug|Placebo capsules|Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).
12042607|NCT00264537|Drug|Methotrexate capsules|Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.
12042608|NCT00264537|Biological|Golimumab 50 mg injections|SC injections
12042609|NCT00264537|Biological|Golimumab 100 mg injections|SC injections
12042610|NCT00264524|Procedure|venipuncture to withdraw patient's blood|
12042611|NCT00264511|Procedure|Hyperbaric Oxygenation|Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.
12042612|NCT00264498|Drug|Gefitinib|oral tablet
12042613|NCT00264498|Drug|Gemcitabine|intravenous injection
12042614|NCT00264498|Drug|Carboplatin|intravenous injection
12042615|NCT00264485|Drug|E-TRANS Fentanyl hydrochloride; Morphine|
12042616|NCT00264472|Drug|ADH300004|5 mg
12042617|NCT00264459|Biological|Grass pollen formulation|"Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
~The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter."
12042618|NCT00264459|Other|Comparator|Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
12042619|NCT00264446|Drug|ADH300004|
12042620|NCT00264433|Drug|ADH -1 (Exherin™)|
12042621|NCT00264420|Drug|zoledronic acid|At baseline 4 mg IV zoledronic acid over 15 min. every 4 weeks for 6 months plus radiation therapy 30 Gy in 10 fractions (5 times per week for first two weeks)
12042622|NCT00264407|Drug|Hormone Replacement Therapy - HRT|
12042623|NCT00264394|Behavioral|Updated CHD risk profiles|Provision of computer generated CHD risk profiles
12042624|NCT00264394|Behavioral|Guidelines|provision of guidelines for CHD risk factor management only
12042625|NCT00264381|Drug|Dalteparin sodium injection|Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days.
12042626|NCT00264368|Drug|intravenous (IV) ganciclovir|
12042627|NCT00264355|Drug|cyclosporine A|
12042628|NCT00264329|Other|Transitional Case Management Study|In an effort to address problems involved in parole re-entry, the Transitional Case Management (TCM) intervention tested a model of strengths-based case management consisting of (1) completion by the inmate of a strengths and goals assessment as part of discharge planning, (2) a telephone conference call that included the inmate and people central to the inmate's aftercare plan (including the parole officer), and (3) strengths case management for 12 weeks in the community to promote treatment participation and increase the client's access to needed services.
12042629|NCT00264316|Procedure|bone marrow-derived stem cell transfer|
12042630|NCT00264303|Drug|Levocetirizine|5mg oral capsules, once daily, 4 week duration
12042631|NCT00264303|Drug|Desloratadine|5mg oral capsules, once daily, 4 week duration
12042632|NCT00264290|Drug|Valganciclovir|900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
12042633|NCT00264290|Drug|Placebo|Placebo designed to resemble Valganciclovir
12042634|NCT00264277|Drug|Vitamin K antagonist (Coumarin anticoagulants)|
12042635|NCT00264264|Procedure|Closure Device|
12042636|NCT00264264|Procedure|Direct Compression|
12042637|NCT00264251|Behavioral|Weight loss through diet and exercise|
12042638|NCT00264251|Drug|Rosiglitazone insulin sensitizing agent|
12042639|NCT00264238|Drug|Memantine|pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
12042640|NCT00264225|Drug|Lamaline® , 3 different doses, Dafalgan codeine|
12042641|NCT00264212|Drug|irbesartan and irbesartan-hydrochlorothiazide|
12042642|NCT00264199|Drug|GLP-1|iv. by weight (1.0 pmol/kg/min )
12042643|NCT00264199|Drug|placebo|same rate of infusion as GLP-1
12042644|NCT00264186|Drug|LPS 2 ng/kg intravenous (IV) bolus|
12042645|NCT00264186|Drug|rhSOD 82,000 IU (8.2 mg)/min intraarterially|
12042646|NCT00264186|Drug|Norepinephrine 60, 120, 240 pmol/min intraarterially over 5 min/dose level (two times; pre-dose and +3.5 hrs)|
12042647|NCT00264186|Drug|Acetylcholine 6.25, 12.5, 25 nmol/min intraarterially over 3 min/dose level (two times; pre-dose and +3.5 hrs)|
12042648|NCT00264186|Drug|Glyceroltrinitrate (nitroglycerine) 4, 8, 16 nmol/min over 3 min/dose level (two times; pre-dose and +3.5 hrs)|
12042649|NCT00264173|Drug|Valproate sodium|
12042650|NCT00264160|Drug|AMN107|
12042651|NCT00264147|Drug|etoricoxib|Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
12042652|NCT00264147|Drug|etoricoxib|Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
12042653|NCT00264147|Drug|etoricoxib|Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
12042654|NCT00264147|Drug|etoricoxib|Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
12042655|NCT00264147|Drug|Comparator: placebo|Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
12042656|NCT00264147|Drug|etoricoxib|Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
12042657|NCT00264147|Drug|Comparator: diclofenac|Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
12042658|NCT00264134|Drug|Docetaxel|
12042659|NCT00264134|Drug|Irinotecan|
12042660|NCT00264134|Drug|Carboplatin|
12042661|NCT00264108|Drug|Darbepoetin alfa|Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.
12042662|NCT00264108|Drug|Epoetin alfa|40,000 IU once weekly, variable treatment length.
12042663|NCT00264095|Procedure|Oncological surgery|surgery is primary observed intervention and blood loss is between 500-3000 ml
12042664|NCT00264082|Drug|Zometa(drug)|
12042665|NCT00264069|Drug|antipsychotic|as prescribed
12042666|NCT00264069|Drug|antidepressants|as prescribed
12042667|NCT00264056|Device|hyperthermia|
12042668|NCT00264043|Device|emboli capturing guidewire device combined with stent|AngioGuard™ device and Bx Velocity™ stent
12042669|NCT00264030|Device|Angioguard distal protection device|PTCA with the Angioguard distal protection device.
12042670|NCT00264030|Other|PTCA|PTCA
12042671|NCT00264004|Drug|AZD2171|30 mg & 45 mg oral tablet
12042672|NCT00263991|Device|EEC-techniques|
12042673|NCT00263978|Drug|Defibrotide|
12042674|NCT00263965|Drug|Tesaglitazar|
12042675|NCT00263965|Drug|Metformin|
12042676|NCT00263965|Behavioral|Dietary and lifestyle modification counseling|
12042677|NCT00263952|Biological|bee venom|
12042678|NCT00263939|Behavioral|Homing in on Health|A peer (non-health professional) delivered intervention to enhance patient self-efficacy for chronic disease self-management. Developed as a modification of the Stanford Chronic Disease Self-Management Program.
12042679|NCT00263926|Biological|wasp venom|
12042680|NCT00263900|Device|RSV respi-strip and Quick-vue influenza|Assessments of 2 quick diagnostic tests in the emergency unit during children's care
12042681|NCT00263887|Drug|Alpha1-Proteinase Inhibitor (Human)|Weekly infusion of 60 mg/kg body weight for 2 years
12042682|NCT00263887|Drug|Albumin (Human) 20%, United States Pharmacopeia (USP)|Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.
12042683|NCT00263874|Drug|UK-500,001|
12042684|NCT00263861|Procedure|management of therapy complications|Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control.
12042685|NCT00263835|Behavioral|Empowerment|
12042686|NCT00263822|Drug|erlotinib hydrochloride|
12042687|NCT00263809|Device|Pathogen Reduction Technology|
12042688|NCT00263796|Drug|Oxytocin|10 international units = 1 cc, IV over 4 hours
12042689|NCT00263796|Drug|Placebo|Normal Saline, IV over 4 hours
12042691|NCT00263770|Device|soft palate implant|
12042692|NCT00263770|Other|Positive airway pressure (PAP)|which is air delivered by a mask worn over the nose during sleep
12042693|NCT00263757|Device|Adaptive Servo-Ventilation|Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.
12042694|NCT00263757|Other|Usual Care|Subjects randomized to this arm received medical management as prescribed by their cardiologist.
12042695|NCT00263744|Biological|MEDI 517|Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant.
12042696|NCT00263744|Other|Aluminum hydroxide|Aluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL.
12042697|NCT00263731|Other|13-C-glucose|"10 grams of 13-C-glucose intravenously, as a 30-minute piggyback infusion, 2 to 6 hours prior to scheduled surgical resection of primary lung cancer."
12042698|NCT00263718|Drug|Calcipotriol plus betamethasone dipropionate (LEO 80185) gel|
12042699|NCT00263705|Drug|Adjuvant capecitabine|Capecitabine 2000 mg/m² daily six cycles
12042700|NCT00263705|Drug|capecitabine in aduvant setting|capecitabine in aduvant setting in ederly with breast cancer
12042701|NCT00263692|Biological|Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3|
12042702|NCT00263679|Biological|Prophylaxis: Diphtheria, tetanus and pertussis|
12042703|NCT00263666|Biological|Rotarix|Oral vaccination
12042704|NCT00263666|Biological|Placebo|Oral administration
12042705|NCT00263666|Biological|Tritanrix-HB+Hib|Concomitant routine vaccination, IM administration
12042706|NCT00263666|Biological|Polio Sabin|Oral administration, concomitant routine vaccination
12042707|NCT00263653|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|
12042708|NCT00263640|Biological|Acaroid|The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.
12042709|NCT00263640|Drug|Placebo|Placebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling.
12042710|NCT00263627|Biological|Birch pollen allergoid|Subcutaneous injections were applied in the upper arm. Vials with three different concentrations were used: Strength A (1000 TU/mL), strength B (10 000 TU/mL) and strength 0 (100 TU/mL) by dilution of strength A.
12042711|NCT00263627|Other|Placebo|Sterile aluminium hydroxide suspension for subcutaneous injection were applied in the upper arm. Vials with strength A contained 0.0125 mg/mL and with strength B 0.125 mg/mL histamine-dihydrochloride and strength 0 was produced by dilution of strength A. The vials containing the placebo solution were identical in their outer appearance with the active study preparation of the birch pollen allergoids.
12042712|NCT00263601|Biological|Allergovit 6-grasses|Subcutaneous injections
12042713|NCT00263601|Other|Placebo|Subcutaneous injections
12042714|NCT00263588|Drug|lapatinib|tyrosine kinase inhibitor
12042715|NCT00263575|Drug|EN3267|EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
12042716|NCT00263562|Drug|Steroid arm|Day 1: Solumedrol 15 mg/kg (maximum 1 gram) Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily
12042717|NCT00263562|Other|Placebo|Patients received normal saline in lieu of intravenously-administered methylprednisolone and placebo pills equal in number to the steroid pills received in the steroid arm
12042718|NCT00263549|Biological|House dust mite Novo Helisen Depot|
12042719|NCT00263536|Procedure|Interpersonal Psychotherapy|
12042720|NCT00263523|Drug|[11C] (-)-RWAY|
12042721|NCT00263497|Device|Temporary tuber-ischii bearing prosthesis|Tuber ischii-bearing holster is connected by hinged metal bars to foot device to enable immediate postoperative mobilization of transtibial amputees. No other medical interventions or pharmaceutical treatment.
12042722|NCT00263484|Drug|dexamethasone|20 mg, PO (orally) on days 1-4, 8-11 and 15-18 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
12042723|NCT00263484|Drug|thalidomide|100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
12042724|NCT00263484|Drug|zoledronic acid|4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
12042725|NCT00263471|Drug|7-methylxanthine|
12042726|NCT00263458|Other|Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting|Eligible opioid-dependent HIV-infected patients are randomly assigned to receive buprenorphine opioid agonist treatment for 12 months either in an integrated HIV primary care setting (intervention group) versus a non-integrated substance use treatment clinic setting (comparison group).
12042727|NCT00263432|Procedure|Human allogenic chondrocytes|Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries
12042728|NCT00263419|Behavioral|Mindfulness Based Stress Reduction|8 weeks mindfulness based stress reduction (MBSR) based on body and meditation practices that aims at cultivation of openness, awareness of the present moment and acceptance of all internal and external experiences. It is assumed that this allows to act more reflectively rather than impulsively.
12042729|NCT00263406|Drug|Administration of an ACE-inhibitor or not|
12042730|NCT00263393|Drug|ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin|The first intervention was a clinical algorithm designed to enhance the identification and treatment of high-risk individuals compared to continued usual care. The algorithm was designed to be used by either physician or non-physician health care workers.
12042731|NCT00263393|Behavioral|Health Promotion|The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.
12042732|NCT00263367|Other|Hyperbaric Oxygen|Hyperbaric Oxygen at 1.3 ATA for one hour
12042733|NCT00263354|Drug|Oxaliplatin|
12042793|NCT00262938|Other|educational intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
12042734|NCT00263341|Combination Product|NES/EE CVR|This is a Phase 3, multicenter, open-label study of a 21/7-day regimen of the 150/15 NES/EE CVR, in healthy women followed on an outpatient basis up to one year (13 cycles) of treatment over one year. Because of the stop treatment date of December 31, 2008 for all participants, women enrolling or re-enrolling in 2008 may not complete a full 13 cycles of treatment. Subjects may also participate in a 6 month follow-up period after the 300B study. The ring is designed to last for 12 months.
12042735|NCT00263328|Drug|Tacrolimus|Standard of care
12042736|NCT00263328|Drug|CP-690,550|CP-690,550 5 mg BID
12042737|NCT00263328|Drug|CP-690,550|CP-690,550 10 mg BID
12042738|NCT00263315|Drug|nebulised liposomal amphotericin B|
12042739|NCT00263302|Drug|dexamethasone|
12042740|NCT00263289|Procedure|preprocedural fasting|
12042741|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
12042742|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 5 mg, Once daily, 12 weeks.
12042743|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 10 mg, Once daily, 12 weeks.
12042744|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 20 mg, Once daily, 12 weeks.
12042745|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 50 mg, Once daily, 12 weeks.
12042746|NCT00263276|Drug|placebo|Tablets, Oral, 0 mg, Once daily, 12 weeks.
12042747|NCT00263276|Drug|metformin|Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.
12042748|NCT00263263|Device|sirolimus-eluting stent|
12042749|NCT00263263|Device|bare metal stent|
12042750|NCT00263250|Procedure|watchful waiting or tension-free hernia repair|
12042751|NCT00263237|Drug|STA-5326|
12042752|NCT00263211|Drug|Plavix|
12042753|NCT00263211|Drug|Aspirin|
12042754|NCT00263198|Drug|PTK787/ZK222584|
12042755|NCT00263198|Drug|Letrozole|
12042756|NCT00263185|Dietary Supplement|Vitamin D|
12042757|NCT00263185|Dietary Supplement|Calcium carbonate|
12042758|NCT00263185|Drug|Vitamin D|
12042759|NCT00263185|Other|Placebo|
12042760|NCT00263172|Behavioral|behavior modification for weight loss|
12042761|NCT00263159|Procedure|Pharmaceutical care for asthma patients|
12042762|NCT00263146|Procedure|recruitment maneuver|
12042763|NCT00263133|Drug|Sertraline|
12042764|NCT00263120|Behavioral|Pain Questionnaire|
12042765|NCT00263107|Procedure|telerounding versus bedside rounding|
12042766|NCT00263094|Drug|Rofecoxib|
12042767|NCT00263081|Drug|Lapaquistat acetate and current lipid-lowering treatment|"Cohort 1: Weight is less than 50 kg:
~Lapaquistat acetate 50 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks.
~Cohort 2: Weight is more than 50 kg:
~Lapaquistat acetate 100 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks."
12042768|NCT00263081|Drug|Current lipid-lowering treatment|Lapaquistat acetate placebo-matching tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks.
12042769|NCT00263068|Drug|Rotigotine|"Transdermal Patch 1 per day for 24 hours containing:
~1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day"
12042770|NCT00263055|Drug|oxaliplatin|
12042771|NCT00263042|Drug|Rimonabant|Tablet, oral administration
12042772|NCT00263042|Drug|Placebo (for Rimonabant)|Tablet, oral administration
12042773|NCT00263029|Drug|Oxaliplatin|60mg/m² as a 2-hour intravenous infusion every week for 5-6 week
12042774|NCT00263029|Drug|Capecitabine|500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart
12042775|NCT00263029|Radiation|Radiotherapy|Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions
12042776|NCT00263016|Drug|Docetaxel|
12042777|NCT00263003|Drug|Irbesartan/hydrochlorothiazide|
12042778|NCT00263003|Drug|Irbesartan|
12042779|NCT00262990|Drug|EPO906 (Patupilone)|
12042780|NCT00262990|Drug|doxorubicin|
12042781|NCT00262977|Behavioral|Electronic prompt plus patient-directed intervention|
12042782|NCT00262977|Behavioral|Electronic prompt to clinician to prescribe aspirin|
12042783|NCT00262964|Drug|Niacin|Subjects randomized to Niacin therapy will be treated with Niacin at night for 16 wks to reduce plasma free fatty acid concentrations. The dose of medication will be gradually increased: 500 mg/day during week 1, 1000 mg/day during week 2, 1500 mg/day during week 3, and 2000mg/day during weeks 4-16.
12042784|NCT00262964|Drug|fenofibrate|Subjects randomized to fenofibrate will be treated with 200 mgs per day for eight weeks.
12042785|NCT00262964|Drug|placebo|Subjects randomized to placebo will be treated with one placebo pill per day for eight weeks.
12042786|NCT00262951|Biological|recombinant interferon alfa|administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1
12042787|NCT00262951|Drug|cisplatin|administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1
12042788|NCT00262951|Drug|fluorouracil|administered at a dose of 175 mg/m^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3
12042789|NCT00262951|Radiation|radiation therapy|5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38).
12042790|NCT00262951|Procedure|Resection of tumor|After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.
12042791|NCT00262938|Behavioral|behavioral dietary intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
12042792|NCT00262938|Other|counseling intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
12042794|NCT00262938|Other|preventative dietary intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
12042795|NCT00262938|Procedure|quality-of-life assessment|Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
12042796|NCT00262925|Biological|alemtuzumab|Given subcutaneously
12042797|NCT00262925|Drug|asparaginase|Given IM
12042798|NCT00262925|Drug|methotrexate|Given IV or orally
12042799|NCT00262925|Drug|dexamethasone|Given orally
12042800|NCT00262925|Drug|leucovorin calcium|Given IV
12042801|NCT00262925|Drug|mercaptopurine|Given orally
12042802|NCT00262925|Drug|vincristine|Given IV
12042803|NCT00262899|Behavioral|counseling intervention|
12042804|NCT00262899|Other|educational intervention|
12042805|NCT00262899|Procedure|psychosocial assessment and care|
12042806|NCT00262886|Biological|anti-thymocyte globulin|
12042807|NCT00262886|Biological|graft-versus-tumor induction therapy|
12042808|NCT00262886|Biological|therapeutic allogeneic lymphocytes|
12042809|NCT00262886|Drug|cyclophosphamide|
12042810|NCT00262886|Drug|fludarabine phosphate|
12042811|NCT00262886|Drug|mycophenolate mofetil|
12042812|NCT00262886|Drug|tacrolimus|
12042813|NCT00262886|Procedure|allogeneic bone marrow transplantation|
12042814|NCT00262886|Procedure|peripheral blood stem cell transplantation|
12042815|NCT00262873|Drug|bortezomib|
12042816|NCT00262860|Drug|bortezomib|
12042817|NCT00262860|Drug|gemcitabine hydrochloride|
12042818|NCT00262847|Biological|Bevacizumab|Given IV
12042819|NCT00262847|Drug|Carboplatin|Given IV
12042820|NCT00262847|Other|Laboratory Biomarker Analysis|Correlative studies
12042821|NCT00262847|Drug|Paclitaxel|Given IV
12042822|NCT00262847|Other|Placebo|Given IV
12042823|NCT00262847|Other|Quality-of-Life Assessment|Ancillary studies
12042824|NCT00262834|Drug|vorinostat|Given orally, conventional surgery to follow.
12042825|NCT00262834|Other|conventional surgery|Undergo conventional surgery
12042826|NCT00262821|Drug|cisplatin|Given IV
12042827|NCT00262821|Drug|tirapazamine|Given IV
12042828|NCT00262808|Biological|sargramostim|
12042829|NCT00262808|Drug|fluorouracil|
12042830|NCT00262808|Drug|leucovorin calcium|
12042831|NCT00262808|Drug|oxaliplatin|
12042832|NCT00262808|Procedure|adjuvant therapy|
12042833|NCT00262808|Procedure|conventional surgery|
12042834|NCT00262808|Procedure|neoadjuvant therapy|
12042835|NCT00262795|Drug|Fludarabine|Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
12042836|NCT00262795|Drug|Chlorambucil|Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month
12042837|NCT00262782|Drug|Fludarabine|Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
12042838|NCT00262769|Drug|cisplatin|25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins
12042839|NCT00262769|Drug|gemcitabine hydrochloride|1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.
12042840|NCT00262743|Biological|Polyphenon E|"Phase I Dose Escalation:. 400 mg orally twice a day to 2000 mg orally twice a day
~Phase II: 2000 mg orally twice a day"
12042841|NCT00262730|Drug|poly ICLC|20 mcg/kg 3x each week (Maintenance cycles)
12042842|NCT00262730|Drug|temozolomide|daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
12042843|NCT00262730|Radiation|radiation therapy|RT: 60 Gy (6 weeks) concomitant therapy
12042844|NCT00262717|Device|HIV drug resistance tests based upon genotype testing|
12042845|NCT00262704|Behavioral|Simulated case-based customized learning|Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback
12042846|NCT00262704|Behavioral|Simulated case based customized learning + leader feedback|Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback + Physician Opinion Leader Feedback Tailored to Provider's Specific Practice Style
12042847|NCT00262678|Drug|EN3267|
12042848|NCT00262665|Drug|ORG 24448|flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
12042849|NCT00262665|Drug|Placebo|matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
12042850|NCT00262652|Drug|sodium pyruvate|
12042851|NCT00262639|Drug|Flumazenil and Gabapentin|2 mg flumazenil for infusion given slowly over 20 minutes given day 1 and day 2 gabapentin 300 mg increasing to 1200 mg over 4 days and continuing to day 30. Gabapentin 900 mg Day 31 to Day 33 gabapentin 600 mg Day 34 to 36 and gabapentin 300 mg Day 37 to 39.
12042852|NCT00262639|Drug|Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
12042853|NCT00262626|Drug|Intraocular pressure reduction|
12042854|NCT00262626|Procedure|Argon laser trabeculoplasty|
12042855|NCT00262626|Procedure|Trabeculectomy|
12042856|NCT00262613|Drug|sodium pyruvate in 0.9% sodium chloride solution|
12042857|NCT00262600|Drug|warfarin|once a day
12042858|NCT00262600|Drug|Dabigatran dose 1|twice daily
12042859|NCT00262600|Drug|Dabigatran dose 2|twice a day
12042860|NCT00262587|Drug|Seretide|Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)
12042861|NCT00262587|Drug|Placebo|Inhaled sugar powder in a placebo inhaler
12042862|NCT00262574|Drug|Nesiritide,|PCI
12042863|NCT00262561|Drug|Aspirin|The effect of Aspirin on platelet function was assessed.
12042864|NCT00262548|Drug|Rosuvastatin; improvement of lipid profile|
12042865|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD
12043223|NCT00259428|Drug|placebo|oral administration
12042866|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD
12042867|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD
12042868|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD
12042869|NCT00262509|Device|Egress Badge|Egress Badge is worn by subjects who are asked to use the badge to exit the building. The badge indicates the direction of each exit sign on route to an exit.
12042870|NCT00262496|Drug|Botox|
12042871|NCT00262483|Drug|VX-950|
12042872|NCT00262483|Drug|ribavirin|
12042873|NCT00262483|Drug|peginterferon alfa-2a|
12042874|NCT00262470|Drug|Acetazolamide|250 mg PO x 1
12042875|NCT00262470|Drug|Atomoxetine|10-40 mg PO x 1 dose
12042876|NCT00262470|Other|NO Drug|No intervention - just monitoring
12042877|NCT00262470|Drug|Clonidine|Clonidine 0.05-0.3 mg PO x 1 dose
12042878|NCT00262470|Drug|Entacapone|Entacapone 200-400 mg PO x 1 dose
12042879|NCT00262470|Drug|Entacapone & Propranolol|Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
12042880|NCT00262470|Drug|Atomoxetine & Propranolol|Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
12042881|NCT00262470|Drug|Indomethacin|Indomethacin 25-50 mg PO x 1 dose
12042882|NCT00262470|Drug|Mecamylamine|mecamylamine 1.25-5 mg PO x 1 dose
12042883|NCT00262470|Drug|Isosorbide Dinitrate|Isosorbide dinitrate 5-20 mg PO x 1 dose
12042884|NCT00262470|Dietary Supplement|Melatonin|melatonin 3 mg PO x 1 dose
12042885|NCT00262470|Drug|Midodrine|midodrine 2.5-10 mg PO x 1 dose
12042886|NCT00262470|Drug|Modafinil|modafinil 100-200 mg PO x 1 dose
12042887|NCT00262470|Drug|Octreotide|octreotide 12.5-50 mcg Subcutaneous x 1 dose
12042888|NCT00262470|Radiation|Placebo|lactose tablet x 1 pill
12042889|NCT00262470|Drug|Propranolol|Propranolol 10-80 mg PO x 1-2 dose
12042890|NCT00262470|Drug|Modafinil & Propranolol|Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
12042891|NCT00262470|Drug|Sertraline|sertraline 25-50 mg PO x 1 dose
12042892|NCT00262470|Procedure|IV Saline|1 liter IV over 2 hours
12042893|NCT00262470|Other|Drinking Water|16 fluid ounces
12042894|NCT00262470|Device|Breathing Device|Breathing through a dead space tube
12042895|NCT00262470|Drug|memantine|memantine 5-20 mg PO x 1 dose
12042896|NCT00262470|Device|Abdominal binder|Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.
12042897|NCT00262457|Device|Implanted gluteal electrical stimulation system|Implanted electrical stimulation system incorporating BION microstimulators
12042898|NCT00262444|Procedure|Different turning frequencies|
12042899|NCT00262431|Procedure|Tracheostomy on day 3-5 in early group and 10-12 in late group|Upon admission to ICU, acute respiratory failure patients requiring at least 3 days of mechanical ventilation and defined by a SAPS II score between 35 and 65, will be randomly assigned to either arm A or B of the study.
12042900|NCT00262418|Drug|Administration of ivermectin or permethrin|
12042901|NCT00262405|Drug|zileuton|
12042902|NCT00262405|Drug|azathioprine/prednisone|
12042903|NCT00262392|Drug|Pamidronate (AREDIA)|Pamidronate (AREDIA) vs radiation
12042904|NCT00262379|Drug|epoetin beta (NeoRecormon®)|• Prescription of the epoetin beta : when blood concentration of hemoglobin is lower or equal to 12 g/dL in male or lower or equal to 11 g/dL in female
12042905|NCT00262366|Device|Comparison of automatic CPAP versus fixed CPAP|
12042906|NCT00262353|Device|Dialysis with different artificial devices|
12042907|NCT00262340|Other|Non invasive measurement of airway inflammation|Airway inflammation will be assessed non-invasively using induced sputum and exhaled nitric oxide. In the active group the results of these tests will be used to determine if asthma treatment should be changed. In the comparator group treatment changes will be based according to conventional symptom based management
12042908|NCT00262327|Drug|Antangiogenesis|
12042909|NCT00262327|Genetic|endostatin gene|
12042910|NCT00262301|Drug|recombinant human C1 inhibitor|IV
12042911|NCT00262301|Drug|Placebo|IV
12042912|NCT00262288|Drug|i.v. recombinant human C1 inhibitor|
12042913|NCT00262275|Drug|Aspirin, Clopidogrel|
12042914|NCT00262262|Drug|Levetiracetam (drug)|The starting dose of levetiracetam was 500 mg/day and the dose was increased with 500 mg every other day to 6 tablets of 500 mg (Keppra, UCB, Belgium), divided into two doses daily corresponding to 3000 mg/day. The dose was kept at this level throughout the remaining treatment period - 4 weeks total. Six placebo tablets with identical appearance were dosed similarly to levetiracetam in the placebo phase.
12042915|NCT00262249|Drug|somatropin|
12042916|NCT00262236|Drug|Aliskiren|
12042917|NCT00262223|Behavioral|Seeking Safety|Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
12042918|NCT00262223|Drug|Sertraline|An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
12042919|NCT00262223|Drug|Pill placebo|
12042920|NCT00262210|Drug|Cyclophosphamide Epirubicin Etoposide Prednisolone|
12042921|NCT00262197|Behavioral|Customized Physician Intervention|
12042922|NCT00262197|Behavioral|Customized Patient Intervention|
12042923|NCT00262184|Drug|Soy Isoflavone|
12042924|NCT00262145|Drug|tea extracts|
12042925|NCT00262132|Drug|Mycophenolate|
12042926|NCT00262119|Device|Pacemaker Medtronic EnRhythm|Pacemaker specific programming
12042927|NCT00262106|Drug|PRO 2000/5|Gel
12042928|NCT00262106|Drug|Placebo|Placebo
12042929|NCT00262080|Drug|ecallantide|dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
12042930|NCT00262080|Drug|Phosphate Buffer Saline (PBS),|given as three 1mL subcutaneous injections.
12042931|NCT00262067|Drug|Bevacizumab|Patients received bevacizumab until disease progression, treatment limiting toxicity, or death due to any cause up to a maximum treatment duration of 48 months. The dose of bevacizumab was based on the patient's weight at either screening or baseline and remained the same throughout the blinded treatment phase of the study. The initial dose was delivered over 90±10 minutes. If there were no infusion related adverse events (fever and/or chills), the second infusion was delivered over 60±10 minutes. If the 60 minute infusion was well tolerated, all subsequent infusions were delivered over 30±10 minutes.
12042932|NCT00262067|Drug|Placebo|Placebo consisted of the vehicle for bevacizumab without the antibody.
12042933|NCT00262067|Drug|Chemotherapy|"The chemotherapy was selected by the investigator prior to randomization. Chemotherapy treatment continued until disease progression, unacceptable toxicity, investigator/patient decision, or death, whichever occurred first, except for the anthracycline-based regimens, which had a maximum treatment duration of 8 cycles.
~Taxanes - 1 of the following 2 taxanes on Day 1 of every 21-day cycle
~Docetaxel 75-100 mg/m^2 IV
~Paclitaxel protein-bound particles (Abraxane®) 260 mg/m^2 IV
~Anthracyclines - 1 of the following 4 anthracycline-based regimens on Day 1 of every 21-day cycle
~5-fluorouracil 500 mg/m^2 IV + epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV
~5-fluorouracil 500 mg/m^2 IV + doxorubicin 50 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV
~Doxorubicin 50-60 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV
~Epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV
~Capecitabine: 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle"
12042934|NCT00262054|Drug|Bivalirudin|bivalirudin to be administered as an intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure.
12042935|NCT00262054|Drug|Un-fractionated heparin|UFH is given as an intravenous bolus of 140 units/kg followed by infusion of placebo 1.75 mg/kg per hour for the duration of the procedure.
12042936|NCT00262041|Biological|MenACWY-CRM conjugate vaccine, adjuvanted|
12042937|NCT00262041|Biological|MenACWY-CRM conjugate vaccine, unadjuvanted|
12042938|NCT00262041|Biological|MenACWY polysaccharide vaccine|
12042939|NCT00262028|Biological|MenACWY-CRM Vaccine|
12042940|NCT00262028|Biological|MenACWY-PS Vaccine|
12042941|NCT00262015|Biological|· Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose)|
12042942|NCT00262002|Biological|MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)|MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
12042943|NCT00262002|Biological|MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)|MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
12042944|NCT00262002|Biological|MenACWY PS (MenACWY-CRM, polysaccharide vaccine)|MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
12042945|NCT00262002|Biological|HBV (Hepatitis B vaccine)|Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
12042946|NCT00262002|Biological|Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)|Prevnar was administered IM in the anterolateral area of the left thigh.
12042947|NCT00262002|Biological|MMR (Measles, Mumps and Rubella vaccine)|MMR at 12 month of age, administered in the left arm.
12042948|NCT00262002|Biological|DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)|DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
12042949|NCT00262002|Biological|Menjugate (Men C conjugated vaccine)|Menjugate was injected IM in the anterolateral area of the right thigh.
12042950|NCT00261976|Drug|Infliximab (Remicade)|This is an non-interventional study. Participants took the study product as part of their medical routine.
12042951|NCT00261963|Device|ultraviolet light|
12042952|NCT00261950|Drug|Sensipar (Cinacalcet HCl)|All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.
12042953|NCT00261937|Drug|Inhaled Furosemide vs Placebo (Normal Saline)|
12042954|NCT00261924|Device|Transfusion of Pathogen Inactivated Platelets stored for 6-7 days|pathogen inactivation of platelets for transfusion
12042955|NCT00261911|Drug|sibutramine|
12042956|NCT00261898|Procedure|Increase sleep|
12042957|NCT00261872|Drug|Methylphenidate|
12042958|NCT00261859|Behavioral|BNI|behavioral- brief intervention
12042959|NCT00261846|Drug|Bosutinib|"Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.
~Part 2, 500 mg oral, continuous, daily dosing."
12042960|NCT00261833|Biological|Alpha1-proteinase inhibitor|60 mg/kg body weight/week intravenous
12042961|NCT00261833|Other|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
12042962|NCT00261820|Drug|tacrolimus|
12042963|NCT00261820|Drug|mycophenolate mofetil|
12042964|NCT00261820|Drug|methylprednisolone|
12042965|NCT00261820|Drug|prednisolone|
12042966|NCT00261820|Drug|sirolimus|
12042967|NCT00261807|Drug|Daptomycin 6mg/kg/day|
12042968|NCT00261794|Behavioral|computer-assisted cognitive remediation (CACR)|36 individual computer sessions with a staff clinician. computer activities consist of commercially available educational software designed for use in the classroom.
12042969|NCT00261794|Behavioral|manualized computer control condition (RC).|36 sessions of a manualized computer control condition.
12042970|NCT00261781|Behavioral|Treadmill training|Walking on a treadmill 3 times per week for 6 weeks
12042971|NCT00261768|Behavioral|Digital noise reduction|
12042972|NCT00261755|Procedure|Acupuncture|Based on international experiences and experiences from the pilot project 34 specified acupuncture points could be used.Treatment was individualised according to the woman's mobility and localization of pain. Needles were sterile stainless steel acupuncture needles in three lengths: 0.20 x 15 mm, 0.30 x 30 mm and 0.35 x 50 mm. No electric stimulation was used. The duration of needling could vary from 30 minutes to two hours and could be repeated. The needles were removed if the patient felt uncomfortable or in cases with obstetric pathology.
12042973|NCT00261755|Other|TENS|The Transcutaneous Electric Nerve Stimulation (TENS treatment) was carried out using a B.C - TENS 120Z unit. Two to four electrodes were placed on the skin of the lower back. The units were set in constant mode, initially with a pulse width of 60 micro-seconds and a pulse rate of 100 pulses per second. The treatment lasted from 20 to 45 minutes and could be repeated. The intensity of stimulation could be adjusted by the woman or the midwife.
12042974|NCT00261755|Other|Traditional Group|All analgesic methods available (Sterile water papules, nitro oxygen, bath tub, pethidine and epidural analgesics (EDA)). A specific analgesic was chosen by the woman and the midwife after informed choice.
12042975|NCT00261742|Drug|Penicillin versus cefuroxim per os|
12042976|NCT00261729|Drug|Paroxetine|paroxetine 20 mg
12042977|NCT00261729|Drug|Prazosin|Prazosin
12042978|NCT00261729|Drug|placebo|placebo capsules
12042979|NCT00261716|Behavioral|IPS|Individual Placement and Support Evidence based supported employment
12042980|NCT00261716|Behavioral|IE|Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search
12042981|NCT00261716|Behavioral|VOMI|Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search
12042982|NCT00261703|Drug|Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy|Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group)
12042983|NCT00261703|Drug|Cisplatin, 5-fluorouracil (5-FU), radiotherapy|Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group)
12042984|NCT00261703|Other|Cisplatin + radiotherapy|Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes)
12042985|NCT00261690|Behavioral|Virtual Reality Distraction|Using virtual reality distraction during a procedure
12042986|NCT00261677|Drug|epoetin alfa|
12042987|NCT00261664|Device|telehomecare|
12042988|NCT00261625|Drug|alendronate|
12042989|NCT00261612|Drug|bortezomib|
12042990|NCT00261612|Drug|rituximab|
12042991|NCT00261612|Drug|dexamethasone|
12042992|NCT00261612|Procedure|treatment protocol|
12042993|NCT00261599|Drug|AQUAVAN® (fospropofol disodium) Injection|
12042994|NCT00261599|Drug|Midazolam HCI|
12042995|NCT00261586|Drug|aspirin, acetaminophen, ibuprofen, naproxen, celecoxib, rofecoxib|
12042996|NCT00261573|Drug|galantamine hydrobromide|
12042997|NCT00261560|Drug|acetaminophen|
12042998|NCT00261547|Drug|Rituximab|All subjects will be treated with Rituximab 1000 mg (1 g) intravenously on days 1 and 15.
12042999|NCT00261521|Drug|epoetin alfa|
12043000|NCT00261508|Drug|risperidone|
12043001|NCT00261495|Drug|OROS hydromorphone HCl|8 to 32 mg once daily for 52 weeks (flexible dosing)
12043002|NCT00261495|Drug|Oxycodone|10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)
12043003|NCT00261482|Drug|norelgestromin + ethinyl estradiol|
12043004|NCT00261469|Drug|topiramate|
12043005|NCT00261456|Behavioral|PSA test|Patients tested for their level of Prostate Specific Antigen.
12043006|NCT00261456|Procedure|Prostate Biopsy|A Prostate biopsy is given as an option to the patient if their PSA level is raised or at the end of 5 years screening.
12043007|NCT00261443|Drug|Lithium or Valproate with placebo (PBO)|"Tablets, Oral, once daily
~lithium 250-2100 mg/day
~valproate 250-2500mg/day
~Placebo once daily"
12043008|NCT00261443|Drug|Lithium or Valproate with Aripiprazole|"Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)
~lithium 250-2100 mg/day
~valproate 250-2500mg/day
~aripiprazole 15-30 mg/day"
12043009|NCT00261430|Behavioral|GAIN Acceptance Approach|
12043010|NCT00261417|Drug|Tesaglitazar|
12043011|NCT00261404|Drug|TNFerade™|
12043012|NCT00261391|Drug|Marimastat|
12043013|NCT00261378|Device|Transarterialchemoembolisation (TACE)|
12043014|NCT00261378|Device|DC Bead with Doxorubicin|
12043015|NCT00261365|Drug|Ipilimumab|Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
12043016|NCT00261365|Drug|Ipilimumab|Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
12043017|NCT00261352|Drug|Tesaglitazar|
12043018|NCT00261352|Drug|Metformin|
12043019|NCT00261352|Drug|Fenofibrate|
12043020|NCT00261339|Drug|Pantoprazole|
12043021|NCT00261326|Drug|simvastatin|80 mg once daily
12043022|NCT00261326|Drug|placebo|calcium tablets once daily
12043023|NCT00261313|Drug|Neulasta|6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy
12043024|NCT00261313|Drug|Aranesp|If Hb drops below 110, 300mcg Aranesp will be administered.
12043025|NCT00261300|Drug|Pantoprazole|Long term Pantoprozole trial
12043026|NCT00261287|Drug|Ciclesonide|
12043027|NCT00261274|Biological|A-ECO|
12043028|NCT00261274|Biological|Saline|
12043029|NCT00261261|Behavioral|ADVANCE|
12043030|NCT00261261|Drug|Midazolam|
12043031|NCT00261261|Procedure|Parental presence|
12043032|NCT00261248|Biological|Immunization with inactivated bacteria|
12043033|NCT00261235|Behavioral|Supported Employment|
12043034|NCT00261235|Behavioral|Using Strengths in Employment System (USES)|
12043035|NCT00261222|Drug|Amodiaquine|
12043036|NCT00261209|Drug|Collagenase|Collagenase injection into adhesion restricting tendon gliding
12043037|NCT00261209|Drug|Collagenase injection|injection of collagenase into adhesion restricting tendon gliding
12043038|NCT00261196|Drug|Collagenase|Anterior shoulder capsule injection
12043039|NCT00261183|Drug|Melatonin|
12043040|NCT00261170|Drug|bupropion|150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks
12043041|NCT00261170|Other|placebo|1 pill daily for the first 3 days, then one pill twice daily for 7 weeks
12043042|NCT00261157|Device|InTouch Telerounding Robot|
12043043|NCT00261144|Drug|Collagenase|One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)
12043044|NCT00261144|Biological|Biological|Collagenase injection
12043045|NCT00261131|Drug|Botulinum Toxin A|
12043046|NCT00261118|Drug|Rituximab|Rituximab 1g in 500 mls Normal Saline Placebo 500 mls Normal Saline
12043047|NCT00261105|Drug|telithromycin|
12043048|NCT00261092|Drug|Oxaliplatin|
12043049|NCT00261079|Drug|Fexofenadine|
12043050|NCT00261053|Drug|i.v. recombinant human C1 inhibitor|
12043051|NCT00261040|Procedure|Minimally Invasive Surgery|In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.
12043052|NCT00261040|Procedure|Standard Surgery|The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision.
12043053|NCT00261027|Drug|Exemestane|
12043054|NCT00261001|Biological|Transcutaneous mode of administration|
12043055|NCT00261001|Biological|Intramuscular mode of administration|
12043056|NCT00260988|Drug|Fragmin (dalteparin)|200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
12043057|NCT00260988|Drug|Innohep (tinzaparin)|175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
12043058|NCT00260962|Drug|Olanzapine|After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
12043059|NCT00260962|Behavioral|Day Hospital|Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
12043060|NCT00260949|Procedure|Arthroscopic repair of rotator cuff tear|Patients will undergo arthroscopic shoulder surgery in the standard fashion
12043061|NCT00260923|Drug|aliskiren|
12043062|NCT00260884|Behavioral|conventional gastrectomy or radical lymph node dissection|
12043063|NCT00260858|Drug|Test Meal: Reference food (glucose or white bread)|
12043064|NCT00260858|Drug|Test Meal: Pirate's Booty|
12043065|NCT00260858|Drug|Test Meal: Ceaprove wafer|
12043066|NCT00260858|Drug|Test Meal: Stretch Island Strawberry Fruit Leather|
12043067|NCT00260832|Drug|Cytarabine or Supportive Care|Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)
12043068|NCT00260832|Drug|Dacogen (decitabine) only|20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.
12043069|NCT00260819|Drug|Bosentan|Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
12043070|NCT00260819|Drug|Bosentam TRACLEER|Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
12043071|NCT00260793|Drug|Ropinirole Hydrochloride|
12043072|NCT00260780|Behavioral|The MISTERS Intervention for Post Jail Release Men|
12043073|NCT00260767|Drug|HEC placebo gel|
12043074|NCT00260754|Behavioral|Community-Popular Opinion Leader Model|
12043075|NCT00260754|Behavioral|Diffusion of Innovations|
12043076|NCT00260741|Drug|Smoked Cannabis|
12043077|NCT00260728|Device|vascular access graft implantation|vascular access graft implantation
12043078|NCT00260715|Behavioral|Community-Popular Opinion Leader Model|
12043079|NCT00260715|Behavioral|Diffusion of Innovations|
12043080|NCT00260702|Drug|Omalizumab (Xolair)|
12043081|NCT00260689|Biological|Anti-thymocyte globulin (rabbit)|
12043082|NCT00260689|Biological|Anti-thymocyte globulin (horse)|
12043083|NCT00260689|Drug|Cyclosporine|
12043084|NCT00260689|Drug|Alemtuzumab|
12043085|NCT00260676|Procedure|change ventilation|reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP
12043086|NCT00260663|Procedure|Group hearing aid fittings|
12043087|NCT00260663|Procedure|Group hearing aid follow-up|
12043088|NCT00260650|Behavioral|Heart PACT Program|patient activation intervention
12043089|NCT00260637|Procedure|Acupuncture|
12043090|NCT00260624|Drug|Escitalopram (Lexapro)|
12043091|NCT00260611|Drug|Oxaliplatin|
12043092|NCT00260611|Drug|Taxotere|
12043093|NCT00260598|Procedure|LIFE Bronchoscopy|The first LIFE Bronchoscopy is performed at least 6 months following surgical resection of primary NSCLC. Timing of subsequent bronchoscopies is dependent on pathology from first bronchoscopy.
12043094|NCT00260585|Procedure|Survey of client health, personal habits, family history|A questionnaire is administered at the time of consent.
12043095|NCT00260585|Procedure|Blood specimen for non-DNA and DNA parts|Blood specimen is collected prior to surgery or at the time of scheduled routine surgical procedure(s), and at the time of routine follow-up visits
12043096|NCT00260585|Procedure|Biopsy of esophageal/stomach tissue, lymph nodes, tumor|Tissue from the biopsies is collected intraoperatively.
12043097|NCT00260585|Procedure|Biopsies from routine clinical surveillance endoscopies|Tissue from the biopsies is collected intraoperatively.
12043098|NCT00260572|Behavioral|Questionnaires to evaluate QOL|Questionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals.
12043099|NCT00260572|Behavioral|Questionnaires to evaluate heartburn and quality of life|Questionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively.
12043100|NCT00260572|Behavioral|Questionnaire to evaluate satisfaction with treatment|Questionnaire administered postoperatively at set intervals.
12043101|NCT00260572|Behavioral|Questionnaire to evaluate presence or absence of pain|Questionnaire administered preoperatively and at set intervals postoperatively.
12043224|NCT00259415|Behavioral|Caregiver support via telephone|
12043102|NCT00260559|Procedure|Questionnaires|Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.
12043103|NCT00260546|Procedure|AV-node ablation|Patients that are randomized to AV node ablation will have their AV-node ablated using a transfemoral approach. Concurrently,a back-up pacing lead will temporarily be placed in the right ventricle.
12043104|NCT00260533|Drug|atomoxetine|Flexible dose, up to 50 mg per day
12043105|NCT00260533|Drug|placebo|placebo (matching to atomoxetine)
12043106|NCT00260520|Drug|Dalteparin|
12043107|NCT00260494|Other|acupuncture|standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.
12043108|NCT00260494|Other|sham acupuncture|standardized sham acupuncture at same sites as acupuncture.
12043109|NCT00260481|Drug|Prometa|Medication protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient medications for 39 days
12043110|NCT00260481|Drug|Placebo|Placebo protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient placebo medications for 39 days.
12043111|NCT00260468|Other|Clinical examination program|Psychiatric/clinical interview MRI scan Blood samples Saliva samples Eye examination
12043112|NCT00260442|Behavioral|Resistance Training|12 weeks, 3 times a week whole body resistance training
12043113|NCT00260442|Behavioral|Sedentary|Absence of physical activity
12043114|NCT00260429|Biological|collagenase clostridium histolyticum|Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
12043115|NCT00260416|Procedure|Primary angioplasty with stent and abciximab|
12043116|NCT00260403|Procedure|Photodynamic therapy versus Transpupillary thermotherapy|
12043117|NCT00260390|Drug|Testoviron|
12043118|NCT00260377|Procedure|Coronary artery bypass surgery|
12043119|NCT00260364|Drug|Gemcitabine 1000 mg/m2 iv days 1, 8, 15 of a 28 day cycle|
12043120|NCT00260364|Drug|Capecitabine orally days 1 -21|
12043121|NCT00260364|Drug|Erlotinib 100 mg orally days 1-28|
12043122|NCT00260364|Drug|Bevacizumab 5 mg/kg intravenously every 2 weeks|
12043123|NCT00260351|Biological|Purified Verocell Rabies Vaccine|0.1 mL, ID (TRC regimen)
12043124|NCT00260351|Biological|Purified Verocell Rabies Vaccine|0.5 mL, IM (ZAGREB regimen)
12043125|NCT00260351|Biological|Purified Verocell Rabies Vaccine|0.5 mL, IM (ESSEN regimen)
12043126|NCT00260338|Biological|stem cell|mesenchymal stromal cell
12043127|NCT00260325|Drug|valdecoxib|
12043128|NCT00260312|Biological|Inactivated Polio Vaccine given at an accelerated schedule|
12043129|NCT00260286|Behavioral|Energy availability|
12043130|NCT00260273|Behavioral|Cognitive Behaviour Therapy|therapy
12043131|NCT00260260|Drug|Oxycodone|
12043132|NCT00260247|Drug|carbamazepine oxcarbazepine|
12043133|NCT00260234|Biological|Allogeneic Cultured Islet Cells (human); Encapsulated|
12043134|NCT00260221|Behavioral|using VR hypnosis/distraction and audio hypnosis|a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
12043135|NCT00260208|Drug|Cyclosporine A|Initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v.) within the first 24 hours post-transplantation.
12043136|NCT00260208|Drug|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses either orally or via a nasogastric (NG) tube or intravenously (i.v).
12043137|NCT00260195|Behavioral|School-based cognitive behavioral support group|
12043138|NCT00260169|Behavioral|Collaborative care treatment|Patients receiving collaborative care treatment choose 12 weeks of CBT and/or medication management (antidepressants prescribed by patients' primary care provider) from the study depression care specialist (DCS).
12043139|NCT00260169|Behavioral|Enhanced usual care|Usual care participants are assigned to a 16-week wait-list for the study treatment, during which they are free to receive treatment elsewhere. A letter is given to participants' primary care providers (PCP) that indicates they screened positive for depression. In addition, patients receive an information booklet about depression and a community resource list.
12043140|NCT00260156|Drug|vildagliptin|
12043141|NCT00260156|Drug|placebo|
12043142|NCT00260143|Drug|Testosterone enanthate|
12043143|NCT00260143|Drug|Placebo|
12043144|NCT00260130|Other|food in fluid form|dietary intake of fluid forms of vegetables
12043145|NCT00260130|Other|food in solid form|dietary intake of solid forms of vegetables
12043146|NCT00260117|Behavioral|Exercise|Referal to a website
12043147|NCT00260091|Procedure|intrauterine insemination|An assisted reproduction technique which deposits washed sperm directly into the uterus, bypassing the cervix, and allowing the sperm to enter the fallopian tubes where fertilization normally occurs.
12043148|NCT00260091|Procedure|infertility|This procedure involves stimulating the ovaries, retrieving released eggs, fertilizing the eggs, growing the embryos in a laboratory, and then implanting the embryos in the woman's uterus to develop naturally.
12043149|NCT00260078|Drug|Atazanavir|200 mg to 400 mg orally daily
12043150|NCT00260078|Drug|Darunavir|300 mg or 600 mg orally twice daily
12043151|NCT00260078|Drug|Efavirenz|Dosage dependent on participant
12043152|NCT00260078|Drug|Nevirapine|Dosage dependent on participant
12043153|NCT00260078|Drug|Ritonavir|50 mg or 100 mg orally twice daily
12043154|NCT00260078|Drug|Tenofovir disoproxil fumarate|300 mg orally daily
12043155|NCT00260078|Procedure|Pharmacokinetic Study|Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
12043156|NCT00260065|Drug|Decitabine|20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
12043157|NCT00260052|Drug|Erythropoietin administration|
12043158|NCT00260039|Biological|Comparator: Gardasil|0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
12043159|NCT00260039|Biological|Comparator: octavalent HPV Vaccine - dose formulation 1|0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
12043349|NCT00258388|Drug|prednisone|5mg PO BID
12043350|NCT00258375|Drug|custirsen sodium|
12043351|NCT00258375|Drug|docetaxel|
12043160|NCT00260039|Biological|Comparator: octavalent HPV Vaccine - dose formulation 2|0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
12043161|NCT00260039|Biological|Comparator: octavalent HPV Vaccine - dose formulation 3|0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
12043162|NCT00260026|Drug|Docetaxel|
12043163|NCT00260026|Drug|Jin Fu Kang|
12043164|NCT00260013|Procedure|program of care delivery|
12043165|NCT00260000|Drug|5,6,7,8-tetrahydrobiopterin|
12043166|NCT00259987|Drug|Lapatinib (GW572016) oral tablets|
12043167|NCT00259974|Drug|Rituximab|Rituximab
12043168|NCT00259961|Procedure|open fundoplication|
12043169|NCT00259961|Procedure|laparoscopic fundopliaction|
12043170|NCT00259948|Procedure|Aerobic exercise training|
12043171|NCT00259935|Drug|topotecan|topotecan
12043172|NCT00259922|Drug|Placebo|Placebo
12043173|NCT00259922|Drug|Alvimopan|0.5 mg QD
12043174|NCT00259922|Drug|Alviompan|0.5 mg BID
12043175|NCT00259909|Other|GSK questionnaire|GSK questionnaire will demonstrate the validity, reliability and responsiveness as a tool for measuring subject-reported outcomes during an acute exacerbation of chronic obstructive pulmonary disease.
12043176|NCT00259909|Other|St. George's Respiratory Questionnaire|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health.
12043177|NCT00259909|Other|Acute Short Form 12 version 2|The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health
12043178|NCT00259909|Other|Global Efficacy questionnaire|Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
12043179|NCT00259896|Drug|exenatide|
12043180|NCT00259883|Drug|paroxetine|1 or 2 tablets once a day
12043181|NCT00259870|Drug|SB-773812|
12043182|NCT00259870|Drug|Olanzapine|
12043183|NCT00259857|Drug|Alendronate|Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
12043184|NCT00259844|Biological|TroVax|
12043185|NCT00259831|Drug|CVT-E002 (Cold-FX); a natural health product|
12043186|NCT00259818|Drug|EM-1421|
12043187|NCT00259805|Drug|Rituximab|375 mg/m2 given as an IV infusion once weekly for four doses
12043188|NCT00259792|Drug|Budesonide/formoterol Turbuhaler|
12043189|NCT00259779|Drug|budesonide/formoterol|
12043190|NCT00259779|Drug|Prednisolone|
12043191|NCT00259766|Drug|Budesonide|
12043192|NCT00259766|Drug|Formoterol|
12043193|NCT00259766|Drug|Terbutaline|
12043194|NCT00259753|Drug|Bevasiranib|
12043195|NCT00259740|Drug|DENOSUMAB|120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.
12043196|NCT00259714|Drug|dialysate sodium individualization|"Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium (individualized)."
12043197|NCT00259714|Drug|standard dialysate sodium|The prescribed dialysate sodium is 140 mEq/L
12043198|NCT00259701|Device|Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin|
12043199|NCT00259688|Device|CPAP therapy for subjects diagnosed with sleep apnea|CPAP therapy is being offered to women who are diagnosed on Polysomnogram with sleep apnea. However, this is not an intervention study and treatment is not part of the study protocol.
12043200|NCT00259675|Drug|carboplatin/gemcitabine, carboplatin/taxol|
12043201|NCT00259662|Drug|atorvastatin|
12043202|NCT00259649|Drug|eletriptan|oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days
12043203|NCT00259636|Drug|zonisamide|zonisamide 100 mg -300 mg daily vs placebo
12043204|NCT00259623|Device|Radiofrequency ablation|
12043205|NCT00259610|Drug|methotrexate|varies
12043206|NCT00259610|Drug|sulfasalazine|varies
12043207|NCT00259610|Drug|hydroxychloroquine|varies
12043208|NCT00259610|Drug|etanercept|varies
12043209|NCT00259597|Procedure|breast ductal lavage|breast ductal lavage and nipple aspiration done once
12043210|NCT00259584|Behavioral|Management and Outcome of SVCO|
12043211|NCT00259571|Drug|retarded release phosphatidylcholine|2g daily, given orally QTD
12043212|NCT00259558|Drug|retarded release phosphatidylcholine|
12043213|NCT00259545|Drug|Retarded Release Phosphatidylcholine (rPC)|
12043214|NCT00259532|Procedure|Ultrasound and contrast agent|contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas
12043215|NCT00259519|Procedure|Induction of delivery|Induction of delivery
12043216|NCT00259506|Behavioral|Mindfulness-Based Cognitive Therapy (MBCT)|
12043217|NCT00259493|Procedure|Off-Pump Coronary Artery Bypass Graft Surgery|
12043218|NCT00259480|Behavioral|Home Based Intervention|occupational therapy
12043219|NCT00259467|Behavioral|Home-Based Behavorial Intervention|
12043220|NCT00259454|Behavioral|In-home intervention|occupational therapy techniques to reduce caregiver stress
12043221|NCT00259441|Drug|Simvastatin|
12043222|NCT00259428|Drug|Dronedarone (SR33589)|oral administration
12043225|NCT00259402|Drug|Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)|OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy
12043226|NCT00259389|Behavioral|Directly observed therapy (DOT)|
12043227|NCT00259376|Drug|Dronedarone (SR33589)|oral administration
12043228|NCT00259376|Drug|placebo|oral administration
12043229|NCT00259363|Drug|Oxaliplatin|oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days
12043230|NCT00259350|Drug|Skin disinfection|
12043231|NCT00259337|Biological|Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine|0.5 mL, IM
12043232|NCT00259324|Behavioral|Diet and Activity|Diet and Activity
12043233|NCT00259311|Drug|LY2422347|
12043234|NCT00259311|Drug|placebo|
12043235|NCT00259298|Drug|teriparatide|Subcutaneous, 20 microgram (mcg)/day, 18 months
12043236|NCT00259285|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
12043237|NCT00259285|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 3 cycles
12043238|NCT00259272|Drug|olanzapine|5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
12043239|NCT00259259|Behavioral|SALATRIM|
12043240|NCT00259246|Drug|Peptide YY infusion|
12043241|NCT00259233|Drug|peripheral Peptide YY administration|
12043242|NCT00259220|Drug|erythomycin|erythomycin
12043243|NCT00259220|Procedure|gastric lavage alone|gastric lavage alone
12043244|NCT00259220|Procedure|erythromycine and gastric lavage|erythromycine and gastric lavage
12043245|NCT00259207|Procedure|Pulmonary valve insertion|Pulmonary valve insertion
12043246|NCT00259207|Procedure|medical surgery hybride|medical surgery hybride
12043247|NCT00259194|Behavioral|Moving|The patients are allowed to lift their head, arms and legs during the 2 hours.
12043248|NCT00259194|Behavioral|No Moving|The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours.
12043249|NCT00259181|Procedure|saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation|
12043250|NCT00259168|Drug|Nateglinide|
12043251|NCT00259155|Drug|Rifaximin|
12043252|NCT00259142|Drug|Chloroquine, sulphadoxine-pyrimethamine|
12043253|NCT00259129|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg twice a day (bid) (2 x 200 mg tablets)
12043254|NCT00259116|Drug|Relaxin|
12043255|NCT00259103|Drug|Serelaxin|
12043256|NCT00259103|Drug|Placebo|
12043257|NCT00259090|Drug|Fulvestrant|500 mg intramuscular injection
12043258|NCT00259090|Drug|Anastrazole|oral tablet
12043259|NCT00259077|Drug|Omeprazole|
12043260|NCT00259064|Drug|Gefitinib|
12043261|NCT00259064|Other|Placebo|
12043262|NCT00259051|Drug|Omeprazole|
12043263|NCT00259038|Drug|Carperitide|
12043264|NCT00259038|Drug|Placebo|
12043265|NCT00259025|Drug|lipid emulsion with a high content of n-3 fatty acids|
12043266|NCT00259012|Drug|pantoprazole sodium enteric-coated spheroid suspension|pediatric suspension taken daily x 7 days
12043267|NCT00258999|Device|Skin Cholesterol Testing|
12043268|NCT00258986|Procedure|Living donornephrectomy|
12043269|NCT00258973|Procedure|Carotid Ultrasound performed in office practice|
12043270|NCT00258960|Drug|Liposomal Doxorubicin|
12043271|NCT00258960|Drug|Cyclophosphamide|
12043272|NCT00258960|Drug|Trastuzumab|
12043273|NCT00258947|Biological|Smallpox vaccine, LISTER strain, from chick embryo cells|
12043274|NCT00258934|Biological|Inactivated, split-virion influenza vaccine|0.1 mL single annual dose
12043275|NCT00258934|Biological|Inactivated, split-virion, influenza virus|0.5 mL single annual dose
12043276|NCT00258908|Biological|Diphteria, tetanus, and Acellular Pertussis vaccine|0.5 mL, Intramuscular
12043277|NCT00258895|Biological|DAPTACEL®: DTaP|0.5 mL, Intramuscular
12043278|NCT00258895|Biological|DAPTACEL®: DTaP|0.5 mL, Intramuscular
12043279|NCT00258882|Biological|Tetanus Toxoid, acellular pertussis, diphtheria toxoid|0.5 mL, Intramuscular
12043280|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
12043281|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
12043282|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
12043283|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
12043284|NCT00258843|Biological|Inactivated Poliomyelitis vaccine|0.5 mL, intramuscular (IM)
12043285|NCT00258843|Biological|Inactivated Poliomyelitis vaccine|0.5 mL, IM
12043286|NCT00258830|Biological|Fluzone®: Influenza Virus Vaccine|0.5 mL, Intramuscular
12043287|NCT00258830|Biological|Fluzone®: Influenza Virus Vaccine|0.5 mL, Intramuscular
12043288|NCT00258817|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (Day 0 and Day 28)
12043289|NCT00258817|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (Day 0)
12043290|NCT00258804|Drug|Insulin glargine|
12043291|NCT00258791|Drug|Ibuprofen|
12043292|NCT00258778|Drug|Human Glucocerebrosidase (prGCD)|
12043293|NCT00258765|Drug|Zoledronic Acid|
12043294|NCT00258765|Drug|Docetaxel|
12043295|NCT00258752|Behavioral|IPT-AST|IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.
12043296|NCT00258752|Other|Enhanced IPT-AST|Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.
12043297|NCT00258752|Other|School counseling|Usual care consists of standard treatments, including individual counseling with guidance counselor.
12043298|NCT00258739|Drug|Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine|Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2.
12043347|NCT00258388|Drug|custirsen sodium|"640mg IV for 2 hours - Cycle 1: Days -7, -5, -3, 1, 8, 15 (4 week cycle)
~Subsequent cycles:
~weekly on days 1, 8, 15 (3 week cycles)"
12043348|NCT00258388|Drug|docetaxel|75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)
12043299|NCT00258739|Other|Docetaxel + gemcitabine + carboplatin + radiotherapy|Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks).
12043300|NCT00258726|Biological|MMR-II|
12043301|NCT00258726|Biological|Pro-Quad|
12043302|NCT00258726|Biological|Varivax|
12043303|NCT00258713|Drug|voclosporin|voclosporin 0.2, 0.3, or 0.4 mg/kg BID
12043304|NCT00258700|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|
12043305|NCT00258687|Biological|GVAX|4 vaccines every two weeks
12043306|NCT00258674|Other|Medicare Claims Feedback|Physician practices received periodic feedback on their performance on selected diabetes quality of care measures as reflected by the Medicare claims data for their patients.
12043307|NCT00258674|Other|Medical Record Review|Physician practices received period feedback on their performance on selected diabetes quality of care measures, as reflected by data collected from their patients' medical records. These data were compiled by trained nurse abstractors using a standardized data collection tool developed for this study.
12043308|NCT00258674|Other|Diabetes Resource Nurse|Diabetes Resource Nurses (DRNs) were registered nurses with 3-5 years of experience as certified diabetes educations who performed initial patient assessments, developed plans of care, administered screening tools, and monitored clinical outcomes. Physicians at the practices randomised to this intervention had could access the DRN's services for their diabetes patients, but neither physicians nor patients had to take advantage of this resource.
12043309|NCT00258661|Procedure|Osteopathic Manipulative Treatment|In addition to conventional treatment for pneumonia, a 10-minute standardized OMT protocol + 5-minute nonstandardized component was performed twice daily for the duration of hospitalization.
12043310|NCT00258661|Procedure|Light-touch Treatment|In addition to conventional treatment for pneumonia, a 10-minute standardized light-touch protocol (designed to mimic OMT standardized protocol) + 5-minute auscultation of carotid bruits, heart, and lungs was performed twice daily for the duration of hospitalization.
12043311|NCT00258635|Biological|RagweedMATAMPL|
12043312|NCT00258622|Drug|NS1209|
12043313|NCT00258622|Drug|Lidocaine|
12043314|NCT00258609|Drug|Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection|
12043315|NCT00258596|Device|sirolimus-eluting stent|
12043316|NCT00258557|Drug|LPV/RTV|400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks
12043317|NCT00258557|Drug|TMC-114/RTV|two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
12043318|NCT00258531|Device|Olympus ScopeGuide®, 3-dimentional magnetic imager|
12043319|NCT00258518|Procedure|mechanical ventilation/CT Scan|evaluation of pleural effusion and respiratory mechanics, CT scan
12043320|NCT00258505|Procedure|Procedure: intracranial monitoring up to 9 days after injury|
12043321|NCT00258492|Behavioral|Aerobic exercise|
12043322|NCT00258479|Drug|ModafinilNicotine Replacement Therapy|A dose escalation design includes eight dose conditions across a 12-day study (nicotine low-high, modafinil low-high and 4 combinations). After day 1 placebo dose, placebo sessions occur in random order during low dose, high dose, and dose-combination testing. Modafinil and nicotine are tested alone with subjects exposed to low active doses prior to higher doses. Dose interactions will be determined with low doses tested in combination followed by low-high dose combinations then high-high dose combination. Doses are administered under double-blind, double dummy procedures. A nicotine patch (0, 7 or 14 mg doses) is applied at 7 am. Modafinil doses are prepared in size 00 opaque capsules. The modafinil dose (0, 100, 200 mg) is administered at 5 PM.
12043323|NCT00258479|Drug|Modafinil|See Modafinil Intervention Description above.
12043324|NCT00258466|Radiation|radiation therapy|
12043325|NCT00258453|Other|metabolic assessment|
12043326|NCT00258453|Other|physiologic testing|
12043327|NCT00258453|Procedure|biopsy|
12043328|NCT00258453|Procedure|computed tomography|
12043329|NCT00258453|Procedure|conventional surgery|
12043330|NCT00258453|Procedure|magnetic resonance imaging|
12043331|NCT00258453|Procedure|management of therapy complications|
12043332|NCT00258453|Procedure|psychosocial assessment and care|
12043333|NCT00258453|Procedure|quality-of-life assessment|
12043334|NCT00258453|Radiation|radiation therapy|
12043335|NCT00258440|Drug|Weekly procrit dosing|The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week.
12043336|NCT00258440|Drug|Interval Dosing|The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.
12043337|NCT00258427|Biological|anti-thymocyte globulin|Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.
12043338|NCT00258427|Biological|filgrastim|given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10^9/L)
12043339|NCT00258427|Drug|busulfan|Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if <4 years old)
12043340|NCT00258427|Drug|cyclophosphamide|10 mg/kg intravenously (IV) on Days -5 through -2.
12043341|NCT00258427|Drug|fludarabine phosphate|35 mg/m^2 intravenously (IV) on Days -5 through -2.
12043342|NCT00258427|Drug|methylprednisolone|1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.
12043343|NCT00258427|Biological|Hematopoietic stem cell transplantation|Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.
12043344|NCT00258401|Dietary Supplement|dietary intervention|At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.
12043345|NCT00258401|Procedure|management of therapy complications|Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
12043346|NCT00258401|Procedure|quality-of-life assessment|Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
12043352|NCT00258362|Drug|carboplatin|Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.
12043353|NCT00258362|Drug|docetaxel|75 mg/m^2 on Day 1 of each course
12043354|NCT00258362|Radiation|radiation therapy|Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)
12043355|NCT00258349|Drug|vorinostat|Given orally
12043356|NCT00258349|Drug|trastuzumab|Given IV
12043357|NCT00258336|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
12043358|NCT00258336|Biological|rituximab|
12043359|NCT00258336|Biological|sargramostim|
12043360|NCT00258323|Drug|cisplatin|20mg/m2d/IV continuous infusion x days
12043361|NCT00258323|Drug|fluorouracil|1000mg/m2/d IV continuous infusion x 4 days
12043362|NCT00258323|Drug|Iressa|250mg po qd days 1-28 then x 2 years
12043363|NCT00258323|Procedure|conventional surgery|conventional surgery
12043364|NCT00258323|Radiation|radiation therapy|150 cGy bid
12043365|NCT00258310|Drug|capecitabine|Capecitabine 1000mg/day for one year
12043366|NCT00258310|Procedure|Surgery, chemotherapy and/or radiotherapy|Surgery, chemotherapy and/or radiotherapy
12043367|NCT00258297|Drug|gefitinib|
12043368|NCT00258297|Procedure|conventional surgery|
12043369|NCT00258297|Procedure|enzyme inhibitor therapy|
12043370|NCT00258297|Procedure|neoadjuvant therapy|
12043371|NCT00258297|Procedure|protein tyrosine kinase inhibitor therapy|
12043372|NCT00258297|Procedure|surgery|
12043373|NCT00258284|Drug|capecitabine|Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
12043374|NCT00258284|Drug|docetaxel|Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
12043375|NCT00258271|Biological|filgrastim|
12043376|NCT00258271|Drug|cladribine|
12043377|NCT00258271|Drug|cytarabine|
12043378|NCT00258271|Drug|imatinib mesylate|
12043379|NCT00258258|Drug|paricalcitol|
12043380|NCT00258258|Drug|zoledronic acid|
12043381|NCT00258245|Dietary Supplement|ascorbic acid|Ascorbic Acid (Vit C)- 1000 mg IVPB after Arsenic Trioxide [ATO] days 1, 4, 8, 11
12043382|NCT00258245|Drug|arsenic trioxide|Arsenic Trioxide (Trisenox)- 0.10→0.15→0.25 mg/kg/dose IVPB days 1, 4, 8, 11
12043383|NCT00258245|Drug|bortezomib|Bortezomib (Velcade)- 0.7→1.0 mg/m2 IVP days 1, 4, 8, 11
12043384|NCT00258245|Drug|dexamethasone|Dexamethasone (Decadron)- 40 mg/days IVPB or PO d 1, 4, 8, 11
12043385|NCT00258245|Drug|thalidomide|Thalidomide (Thalomid) - 50 mg/day by mouth (PO)
12043386|NCT00258245|Drug|Aspirin|Aspirin - 325 mg by mouth (PO) every day
12043387|NCT00258232|Drug|capecitabine|
12043388|NCT00258232|Drug|celecoxib|
12043389|NCT00258232|Drug|irinotecan hydrochloride|
12043390|NCT00258206|Biological|rituximab|
12043391|NCT00258206|Drug|cyclophosphamide|
12043392|NCT00258193|Drug|MD-1100 Acetate|
12043393|NCT00258180|Biological|filgrastim|Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
12043394|NCT00258180|Drug|cyclophosphamide|Administered IV over 1 hour on days 1-4
12043395|NCT00258167|Behavioral|"filling the Experience of Caregiving Inventory"|8 weeks of group therapy for family members
12043396|NCT00258154|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
12043397|NCT00258154|Biological|Comparator: placebo|3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
12043398|NCT00258154|Biological|Comparator: Infanrix(tm) Hexa|3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
12043399|NCT00258141|Drug|Rupatadine|
12043400|NCT00258141|Drug|Placebo|
12043401|NCT00258128|Drug|Salsalate|Active
12043402|NCT00258128|Drug|Placebo|Placebo for salslate, used only in the third trial
12043403|NCT00258115|Drug|salsalate|
12043404|NCT00258102|Drug|Levofloxacin|
12043405|NCT00258089|Drug|Levofloxacin|
12043406|NCT00258076|Drug|EVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EE|
12043407|NCT00258063|Drug|EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol (versus CILEST® tablets).|
12043408|NCT00258050|Drug|Midazolam|Subjects will receive midazolam by oral or IV route on Days 1, 3, 9 and 11. Oral midazolam was supplied as 3 mg tablets; IV midazolam was supplied as 1 milligram per milliliter (mg/L) sterile solution.
12043409|NCT00258050|Drug|Lapatinib|Subjects will receive 1500 mg lapatinib by oral route once daily from Day 4.
12043410|NCT00258037|Behavioral|Pelvic Floor Muscle training|
12043411|NCT00258024|Drug|IPT-sulphadoxinepyrimethamine|
12043412|NCT00258011|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|0.58 mg/kg every week
12043413|NCT00257998|Procedure|Mobilization|manualtherapy techniques
12043414|NCT00257985|Drug|GTN|
12043415|NCT00257972|Drug|aripiprazole|
12043416|NCT00257959|Drug|amiodarone beta blocker sotalol|
12043417|NCT00257946|Procedure|Repair of CDH w/SIS Gold|
12043418|NCT00257946|Procedure|Repair of CDH w/Alloderm|
12043419|NCT00257933|Drug|Prednisolone high dose|4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
12043420|NCT00257933|Drug|Prednisolone lower dose|2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
12043421|NCT00257920|Drug|Zemplar® injection|6 mcg QOD
12043422|NCT00257920|Drug|Hectorol® injection|3.6 mcg QOD
12043493|NCT00257296|Other|Usual Care|Screening for intimate partner violence and provide enhanced usual care which includes providing resource list, educating medical staff and partner violence and instructing physicians to help all patients regardless of assigned arm.
12043423|NCT00257894|Drug|Baclofen|Dosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12).
12043424|NCT00257894|Drug|Placebo|Matched placebo capsules containing inert filler taken orally for a total of 12 days
12043425|NCT00257881|Drug|CMD-193|
12043426|NCT00257868|Drug|Rivastigmine prevention of delirium|
12043427|NCT00257855|Drug|Lamotrigine|
12043428|NCT00257842|Procedure|Standard treatment, sham feedback and biofeedback therapy|
12043429|NCT00257829|Drug|Methazolamide|
12043430|NCT00257829|Drug|Cisplatin|
12043431|NCT00257816|Drug|Topotecan|"(First stage of accrual, 6 patients)-2 mg/m2 IV on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)
~If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks, then the second Stage of accrual (an additional 6 patients) will increase the Topotecan dose to 3 mg/m2 on days 1, 8, 15, 22, 29 and once during parametrical boost (6 cycles). If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, the dose of the Topotecan will remain the same in the second Phase of accrual. If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, there will be no second phase of accrual."
12043432|NCT00257816|Drug|Cisplatin|40 mg/m2 IV (Maximum total dose of 70 mg) on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)
12043433|NCT00257803|Drug|Oxytocin|See detailed description
12043434|NCT00257803|Drug|Saline solution|See detailed description
12043435|NCT00257790|Drug|Tobramycin once a day|
12043436|NCT00257777|Procedure|Myocardial protection techniques|
12043437|NCT00257764|Behavioral|behavioral swallowing exercises/ strategies|
12043438|NCT00257751|Procedure|Aprotinine|
12043439|NCT00257738|Biological|MAGE-A3|Three dose levels of MAGE-A3 vaccine will be tested : 500ug, 1000 ug and 1500 ug
12043440|NCT00257738|Biological|HPV-16 vaccine|Three dose levels of HPV- 16 vaccine will be tested : 500ug, 1000 ug and 1500 ug
12043441|NCT00257725|Drug|B-MPH|Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
12043442|NCT00257712|Drug|TH9507 human growth hormone releasing hormone (GHRH)|1mg subcutaneous injection given daily for 20 weeks
12043443|NCT00257699|Drug|Metronidazole placebo|
12043444|NCT00257699|Drug|ciprofloxacin placebo|
12043445|NCT00257699|Drug|ciprofloxacin|500 mg bid po
12043446|NCT00257699|Drug|metronidazole|250 mg bid po / 250 mg tid po / 500 mg bid po depending on body weight
12043447|NCT00257686|Drug|Pitavastatin|
12043448|NCT00257686|Drug|Pravastatin|
12043449|NCT00257673|Drug|MEM 1003|30 mg twice a day
12043450|NCT00257673|Drug|MEM 1003|90 mg MEM 1003 twice a day
12043451|NCT00257673|Drug|Placebo for MEM 1003|Placebo twice a day
12043452|NCT00257660|Biological|Botulinum toxin type A|500 units
12043453|NCT00257660|Drug|Placebo|500 units
12043454|NCT00257647|Other|SV40 vectors carrying siRNA|in vitro only use of gene therapy
12043455|NCT00257634|Drug|dexamethasone to injury site|
12043456|NCT00257621|Drug|GW640385|
12043457|NCT00257621|Drug|Ritonavir|
12043458|NCT00257608|Drug|bevacizumab|Intravenous repeating dose
12043459|NCT00257608|Drug|placebo|Oral repeating dose
12043460|NCT00257608|Drug|erlotinib HCl|Oral repeating dose
12043461|NCT00257595|Drug|Cetirizine Dry Syrup|
12043462|NCT00257582|Drug|Cetirizine Dry Syrup|
12043463|NCT00257569|Drug|Cetirizine Dry Syrup|
12043464|NCT00257556|Drug|Menotrophin|150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
12043465|NCT00257556|Drug|Follitropin alfa|150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
12043466|NCT00257543|Procedure|Alternative donor bone marrow and cord blood|bone marrow transplant - alternative donors for bone marrow and cord blood transplants
12043467|NCT00257530|Drug|Imiquimod|
12043468|NCT00257491|Drug|Telmisartan|
12043469|NCT00257491|Drug|Telmisartan/HCTZ|
12043470|NCT00257478|Drug|YM155|
12043471|NCT00257465|Biological|Autologous, DNP-modified vaccine (M-Vax)|5.0, 2.5, 0.5, or 0 cells
12043472|NCT00257465|Biological|Autologous, DNP-Modified Melanoma Vaccine|5 million cells
12043473|NCT00257465|Biological|Autologous, DNP-Modified Vaccine|2.5 million cells
12043474|NCT00257465|Biological|Autologous, DNP-Modified Vaccine|0.5 million cells
12043475|NCT00257465|Biological|Autologous, DNP-Modified Vaccine|0 cells
12043476|NCT00257452|Drug|tiotropium 18 mcg or 54 mcg qd|
12043477|NCT00257452|Drug|placebo matching tiotropium qd|
12043478|NCT00257452|Drug|moxifloxacin 200 mg|
12043479|NCT00257426|Drug|octreotide acetate|200mcg,3 times per day, 7 days per week, up to 36 weeks
12043480|NCT00257413|Procedure|Transplantation of autologous endothelial progenitor cells|
12043481|NCT00257400|Behavioral|Interpersonal Psychotherapy (IPT)|Interpersonal Psychotherapy
12043482|NCT00257400|Behavioral|Individual Psychotherapy|Individual Psychotherapy
12043483|NCT00257387|Drug|Cyclosporine|
12043484|NCT00257374|Drug|Gatorade, Pedialyte and New Solution|
12043485|NCT00257361|Drug|D-Cycloserine|
12043486|NCT00257348|Drug|Capecitabine|
12043487|NCT00257348|Drug|Docetaxel|
12043488|NCT00257335|Procedure|IMRT|
12043489|NCT00257322|Drug|GM-CSF|250ug/m^2 SQ QD with a cap of 500mcg SQ QD
12043490|NCT00257309|Drug|Tenecteplase + UFH (+ clopidogrel, since 01/97)|
12043491|NCT00257309|Procedure|Primary angioplasty|
12043492|NCT00257296|Other|Screening and Intervention|Screening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient
12043494|NCT00257283|Drug|Omega-3-acid ethyl esters 90|
12043495|NCT00257270|Drug|gabapentin|
12043496|NCT00257257|Drug|Rimonabant (SR141716)|
12043497|NCT00257218|Behavioral|Life style modification|
12043498|NCT00257205|Drug|dacarbazine|decarbazine 1000 mg/m2 IV Q 21 days x 12
12043499|NCT00257205|Drug|CP-675,206|CP-675,206 15 mg/kg IV Q 90 days x 4
12043500|NCT00257205|Drug|temozolomide|temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
12043501|NCT00257192|Drug|placebo|Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
12043502|NCT00257192|Drug|Ziprasidone oral capsules|Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg BID to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
12043503|NCT00257166|Drug|Ziprasidone oral capsules|Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
12043504|NCT00257166|Drug|placebo oral capsules|Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
12043505|NCT00257153|Device|Coronary thrombus aspiration catheter|
12043506|NCT00257140|Drug|levofloxacin|
12043507|NCT00257127|Biological|Pneumococcal 7-valent conjugate vaccine|0.5 mL administered intramuscularly
12043508|NCT00257127|Biological|Pneumococcal polysaccharide vaccine|0.5 mL administered intramuscularly
12043509|NCT00257127|Biological|Hepatitis B vaccine|0.5 mL administered intramuscularly
12043510|NCT00257127|Biological|Measles, mumps, and rubella virus vaccine, live|0.5 mL administered subcutaneously
12043511|NCT00257114|Drug|bortezomib|
12043512|NCT00257101|Behavioral|self-medication monitoring|
12043513|NCT00257088|Behavioral|whole day first grade program|
12043514|NCT00257075|Drug|Risperidone, oral tablets|
12043515|NCT00257062|Drug|Levofloxacin|
12043516|NCT00257049|Drug|levofloxacin|
12043517|NCT00257036|Drug|levofloxacin|
12043518|NCT00257023|Drug|paliperidone|
12043519|NCT00257010|Drug|Almotriptan Malate|Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
12043520|NCT00256997|Drug|Risperidone long-acting injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.
12043521|NCT00256997|Drug|Oral atypical Antipsychotic|Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
12043522|NCT00256984|Procedure|Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler|
12043523|NCT00256971|Procedure|meniscectomy|
12043524|NCT00256958|Procedure|total knee replacement|
12043525|NCT00256945|Procedure|dental restorative material surface preparation|
12043526|NCT00256932|Drug|alvimopan|0.5 mg
12043527|NCT00256932|Drug|Placebo|
12043528|NCT00256919|Drug|GW856553|
12043529|NCT00256893|Drug|ropinirole|
12043530|NCT00256880|Drug|GW786034|
12043531|NCT00256867|Drug|GSK523338|
12043532|NCT00256854|Drug|Ropinirole IR 1 mg|Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.
12043533|NCT00256854|Drug|Ropinirole IR 2 mg|Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.
12043534|NCT00256854|Drug|Ropinirole IR 1 mg Placebo|Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.
12043535|NCT00256854|Drug|Ropinirole IR 2 mg Placebo|Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
12043536|NCT00256854|Drug|Ropinirole CR 2 mg|Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.
12043537|NCT00256854|Drug|Ropinirole CR 3 mg|Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.
12043538|NCT00256854|Drug|Ropinirole CR 2 mg Placebo|Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
12043539|NCT00256854|Drug|Ropinirole CR 3 mg Placebo|Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.
12043540|NCT00256841|Drug|Chemotherapy|
12043541|NCT00256841|Procedure|Radiation Therapy|
12043542|NCT00256828|Drug|didanosine + lamivudine + efavirenz|
12043543|NCT00256815|Drug|chemotherapy|
12043544|NCT00256815|Procedure|Radiation|
12043545|NCT00256802|Device|MR-angiography, GTN|
12043546|NCT00256789|Procedure|Radiation|
12043547|NCT00256789|Drug|Chemotherapy|
12043548|NCT00256776|Drug|Velcade (Bortezomib)|
12043549|NCT00256776|Drug|Thalidomide|
12043550|NCT00256776|Drug|Dexamethasone|
12043551|NCT00256750|Drug|Cyclosporine (CsA)|tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)
12043552|NCT00256750|Drug|Belatacept LI (less intensive)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
12043615|NCT00256204|Drug|Rasagiline Mesylate|tablet, 1mg once daily
12043553|NCT00256750|Drug|Belatacept MI (more intensive)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
12043554|NCT00256737|Drug|Omeprazole|
12043555|NCT00256724|Device|Impedance Threshold Device|Active impedance threshold device
12043556|NCT00256724|Device|sham ITD|sham impedance threshold device
12043557|NCT00256711|Drug|Gefitinib|
12043558|NCT00256711|Drug|Vinorelbine|
12043559|NCT00256698|Drug|Fulvestrant|intramuscular injection 250 mg loading dose (LD) regimen
12043560|NCT00256698|Drug|Anastrozole|1 mg oral tablet
12043561|NCT00256685|Drug|DVS-233 SR|
12043562|NCT00256672|Device|Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam|TLSO back brace, Flex-Foam (Posterior Opening)
12043563|NCT00256659|Behavioral|Early assessment and referral to ancillary care services vs. standard care|
12043564|NCT00256646|Drug|Rosiglitazone|ROSIGLITAZONE (roe si GLI ta zone) helps to treat type 2 diabetes. It helps to control blood sugar. Treatment is combined with diet and exercise.
12043565|NCT00256620|Procedure|Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized|
12043566|NCT00256594|Device|prescription form|Two prescription pads contained modified forms and two prescription pads were similar to the prescription pads the prescriber had been using. Providers completed 100 standard and 100 modified prescriptions
12043567|NCT00256581|Procedure|Additional rest and stress image sets on new camera|
12043568|NCT00256568|Behavioral|reporting system|Nurses and office staff were asked to report all communications with community pharmacists regarding prescription problems
12043569|NCT00256555|Drug|Nutropin AQ|
12043570|NCT00256542|Drug|Alkalinized Lidocaine-Heparin|
12043571|NCT00256529|Procedure|EGD with biopsies|All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
12043572|NCT00256516|Other|Eco-Atkins diet (high vegetable protein and vegetable fat)|
12043573|NCT00256516|Other|NCEP diet|
12043574|NCT00256503|Behavioral|Cognitive-Behavioral Therapy for Insomnia|Insomnia Subjects receive CBT-I
12043575|NCT00256490|Procedure|PET/CT 20 days after the first cycle of chemotherapy|
12043576|NCT00256477|Behavioral|Sudarshan KRIYA Breathing Technique|
12043577|NCT00256464|Behavioral|Multi-component Yoga Intervention|
12043578|NCT00256451|Drug|Naltrexone|50 mg/day for two days prior to the alcohol challenge session
12043579|NCT00256451|Drug|placebo|placebo pills
12043580|NCT00256451|Other|alcohol|190 proof alcohol prepared to 11% volume mixed with fruit juice.
12043581|NCT00256451|Other|Sham alcohol|non-alcoholic placebo alcohol
12043582|NCT00256438|Device|Transcranial Direct Current Stimulation|
12043583|NCT00256425|Behavioral|Cognitive rehabilitation|
12043584|NCT00256412|Drug|Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day|Placebo and Omega 3 capsules. All participants receive 4 capsules with either 0, 2, or 4 capsules containing omega 3.
12043585|NCT00256412|Drug|Placebo|4 capsules of placebo each day
12043586|NCT00256399|Drug|Alfuzosin 10 mg|
12043587|NCT00256386|Device|Electronic Medical Record (EMR) to clinician's in-basket|
12043588|NCT00256386|Device|Automated Voice Message (AVM) reminder to patient's phone|
12043589|NCT00256386|Procedure|Pharmacy Team phone call-letter followup|
12043590|NCT00256373|Procedure|Mod. functional restoration-Individ. dynamic back-muscle|
12043591|NCT00256360|Drug|dose dense with neulasta|
12043592|NCT00256347|Drug|intramuscular injections of morphine|
12043593|NCT00256334|Drug|Resveratrol|Patients were randomly assigned to one of four dose cohorts: plant-derived resveratrol tablets (purchased through the Life Extension Foundation, Scottsdale, AZ) at a dose of 80 mg/day, plant-derived resveratrol tablets at a dose of 20 mg/day, Grape Powder (GP) dissolved in water and taken orally (supplied by the California Table Grape Commission) at a dose of 120 g/day, and GP at a dose of 80 g/day.
12043594|NCT00256321|Drug|Oxaliplatin|Oxaliplatin 70mg/m2 IV on Days 1 and 8
12043595|NCT00256321|Drug|Capecitabine|Capecitabine 1000mg/m2 PO BID from Days 1 through 14.
12043596|NCT00256321|Drug|Celecoxib|Celecoxib 400mg PO BID from Days 1 through 21.
12043597|NCT00256308|Drug|Oxaliplatin|70mg/m2 IV over 120 min once a week during radiation
12043598|NCT00256308|Procedure|Radiation|200 cGy/day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday
12043599|NCT00256295|Drug|Gemcitabine|1000 mg/m2 IV over 100 minutes Every 21 days
12043600|NCT00256295|Drug|Oxaliplatin|65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
12043601|NCT00256282|Drug|Vinorelbine|30 mg/m2 IV over 6-10 min every 14 days
12043602|NCT00256282|Drug|Docetaxel|40mg/m2 IV over 1 hour every 14 days
12043603|NCT00256282|Drug|Sargramostim|250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
12043604|NCT00256269|Drug|Oxaliplatin|40 mg/m2 IV over 60 minutes Every 21 days
12043605|NCT00256269|Drug|Irinotecan|60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days
12043606|NCT00256256|Drug|glucagon-like-peptide-1|Dose: 1.2pmol/kg/min for 6 hours
12043607|NCT00256243|Drug|Doxorubicin|60 mg/m2 IV, bolus once every 14 days x 2-4 cycles
12043608|NCT00256243|Drug|Cyclophosphamide|600 mg/m2 IV once every 14 days x 2-4 cycles
12043609|NCT00256243|Drug|Paclitaxel|80 mg/m2 IV over 1 hour once weekly for 9-12 doses beginning two weeks after completion of last AC dose
12043610|NCT00256243|Drug|Carboplatin|Area under the concentration curve (AUC) 2 IV once weekly for 9-12 doses beginning two weeks after completion of last AC dose
12043611|NCT00256243|Drug|GM-CSF|250 μg/mL IV on day 5-14 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
12043612|NCT00256243|Drug|Trastuzumab|AUC 2 IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
12043613|NCT00256230|Drug|Disulfiram (DSF)|DSF pills at 250 mg will be given orally, two times a day. If this dose is tolerated, the dose will be escalated until the maximum tolerated dose is reached. Treatment will continue every day for 3 months or longer unless the disease gets worse, the side effects are too dangerous for the subject, or the subject decides to discontinue treatment.
12043614|NCT00256217|Drug|Anastrozole|1 mg. oral every day for 2 - 4 weeks
12043616|NCT00256204|Drug|Rasagiline Mesylate|tablet, 2mg once daily
12043617|NCT00256204|Other|Placebo|Placebo
12043618|NCT00256191|Drug|TPI 287 Injection|
12043619|NCT00256178|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
12043620|NCT00256178|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
12043621|NCT00256178|Drug|Simvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
12043622|NCT00256165|Device|Tissue valve|Aortic valve replacement
12043623|NCT00256152|Device|AF Suppression Pacing Algorithm|
12043624|NCT00256139|Drug|Raptiva|
12043625|NCT00256126|Drug|Saizen|Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month
12043626|NCT00256126|Drug|Saizen|Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
12043627|NCT00256113|Drug|Saredutant succinate (SR48968C)|
12043628|NCT00256100|Drug|Fondaparinux Sodium|The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation
12043629|NCT00256087|Drug|Probiotic Lactobacillus|
12043630|NCT00256087|Other|Lactose Powder|
12043631|NCT00256074|Procedure|Enteral feeding formula|
12043632|NCT00256048|Procedure|Nasojejunal feeding|
12043633|NCT00256035|Procedure|Measuring IL-4 levels|
12043634|NCT00256022|Drug|Lactobacillus Probiotic|
12043635|NCT00256022|Other|Lactose Powder|
12043636|NCT00256009|Drug|Cytotec|
12043637|NCT00255996|Drug|linezolid|
12043638|NCT00255983|Drug|Faropenem medoxomil|600 mg BID for 5 days
12043639|NCT00255983|Drug|placebo|placebo tablets BID for 5 days
12043640|NCT00255970|Other|DFDBA|Demineralized Freeze Dried Allograft bone
12043641|NCT00255970|Device|Regenafil|Demineralized Freeze Dried Bone in a porcine gel carrier
12043642|NCT00255957|Drug|HES administration|
12043643|NCT00255957|Drug|Hydroxy Ethyl Starch administration to stroke patients|
12043644|NCT00255944|Behavioral|Youthnet Internet-based program|Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness.
12043645|NCT00255944|Behavioral|Control Internet based program|The control program will deliver standard STD/HIV prevention messages.
12043646|NCT00255931|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy and Relaxation/biofeedback
12043647|NCT00255931|Behavioral|Attention Placebo|Untrained relaxation
12043648|NCT00255918|Drug|Dimethoxybenzylidene anabaseine (DMXB-A)|DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose
12043649|NCT00255918|Drug|Placebo|Placebo dosed to match active medication
12043650|NCT00255918|Drug|Dimethoxybenzylidene anabaseine (DMXB-A)|DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose
12043651|NCT00255905|Behavioral|Cognitive behavioral therapy (CBT) for insomnia|
12043652|NCT00255905|Behavioral|Clinician monitoring|
12043653|NCT00255879|Drug|Quetiapine|
12043654|NCT00255879|Drug|Risperidone|
12043655|NCT00255879|Drug|Olanzapine|
12043656|NCT00255866|Behavioral|Skills training for the care of dementia patients|
12043657|NCT00255840|Behavioral|Monitoring by an HIV-trained medical doctor|Participants will receive care from an HIV-trained medical doctor
12043658|NCT00255840|Behavioral|Monitoring by an HIV-trained primary care nurse|Participants will receive care from an HIV-trained primary care nurse
12043659|NCT00255840|Drug|Efavirenz|600 mg tablet taken orally daily
12043660|NCT00255840|Drug|Lamivudine|150 mg tablet taken orally daily
12043661|NCT00255840|Drug|Lopinavir/Ritonavir|400 mg lopinavir/100mg ritonavir tablet taken orally twice daily
12043662|NCT00255840|Drug|Nevirapine|200 mg tablet taken orally for 14 days before taking a 200 mg tablet orally twice daily
12043663|NCT00255840|Drug|Stavudine|Tablet taken orally daily. Dosage depends on weight.
12043664|NCT00255827|Biological|HyperAcute-Pancreatic Cancer Vaccine|
12043665|NCT00255814|Radiation|radiation therapy|
12043666|NCT00255801|Drug|Targretin® (bexarotene)|
12043667|NCT00255801|Drug|pegylated liposomal doxorubicin hydrochloride|
12043668|NCT00255788|Drug|everolimus|
12043669|NCT00255775|Dietary Supplement|broccoli sprout extract|
12043670|NCT00255775|Procedure|complementary or alternative medicine procedure|
12043671|NCT00255762|Drug|carboplatin|Given IV
12043672|NCT00255762|Drug|paclitaxel|Given IV
12043673|NCT00255762|Biological|bevacizumab|Given IV
12043674|NCT00255762|Other|laboratory biomarker analysis|Correlative studies
12043675|NCT00255749|Biological|epoetin alfa|
12043676|NCT00255723|Drug|carboplatin|Given IV
12043677|NCT00255723|Drug|etoposide|Given IV
12043678|NCT00255723|Drug|ifosfamide|Given IV
12043679|NCT00255710|Biological|filgrastim|
12043680|NCT00255710|Drug|cyclophosphamide|
12043681|NCT00255710|Drug|fludarabine phosphate|
12043682|NCT00255710|Drug|mycophenolate mofetil|
12043683|NCT00255710|Drug|tacrolimus|
12043684|NCT00255710|Procedure|allogeneic bone marrow transplantation|
12043685|NCT00255710|Procedure|peripheral blood stem cell transplantation|
12043686|NCT00255710|Radiation|radiation therapy|
12043755|NCT00255125|Drug|Soy Supplement|Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
12043999|NCT00253500|Drug|epirubicin hydrochloride|120 MG q 2 weeks for 4 cycles
12044000|NCT00253500|Procedure|conventional surgery|to remove small piece of cancer
12044001|NCT00253487|Drug|O6-benzylguanine|
12043687|NCT00255697|Procedure|psychosocial assessment and care|Patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including Functional Assessment of Cancer Therapy (FACT), Spiritual tool, Quality and Satisfaction with Treatment (QUEST), and Profile of Mood State (POMS), at baseline and at 3 and 12 months. Caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the Caregiver Reaction Assessment (CRA), Quest, and POMS, at baseline and at 3 and 12 months. Caregivers complete the Quality of Death and Dying (QODD) questionnaire 2-3 months after the patient's death.
12043688|NCT00255697|Procedure|quality-of-life assessment|Patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including Functional Assessment of Cancer Therapy (FACT), Spiritual tool, Quality and Satisfaction with Treatment (QUEST), and Profile of Mood State (POMS), at baseline and at 3 and 12 months. Caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the Caregiver Reaction Assessment (CRA), Quest, and POMS, at baseline and at 3 and 12 months. Caregivers complete the Quality of Death and Dying (QODD) questionnaire 2-3 months after the patient's death.
12043689|NCT00255684|Biological|graft-versus-tumor induction therapy|
12043690|NCT00255684|Drug|cyclophosphamide|
12043691|NCT00255684|Drug|cyclosporine|
12043692|NCT00255684|Drug|fludarabine phosphate|
12043693|NCT00255684|Drug|mycophenolate mofetil|
12043694|NCT00255684|Procedure|umbilical cord blood transplantation|
12043695|NCT00255684|Radiation|radiation therapy|
12043696|NCT00255671|Other|Questionnaire|Patients complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.
12043697|NCT00255658|Drug|sorafenib tosylate|Given orally
12043698|NCT00255658|Drug|temsirolimus|Given IV
12043699|NCT00255658|Other|laboratory biomarker analysis|Correlative studies
12043700|NCT00255619|Device|Baxter's UltraBag® and FMC Andy·Disc®|
12043701|NCT00255606|Drug|docetaxel|Given in 3- or 4- week courses
12043702|NCT00255606|Drug|prednisone|Given in 3- or 4- week courses
12043703|NCT00255593|Drug|rituximab|
12043704|NCT00255580|Drug|Smoked cannabis|
12043705|NCT00255567|Drug|Sodium Stibogluconate|Sodium Stibogluconate 20mg/kg/day for 30 days
12043706|NCT00255567|Drug|Paromomycin sulphate|Paromomycin sulphate
12043707|NCT00255567|Drug|SSG and Paromomycin sulphate|SSG and Paromomycin Sulphate 17 days
12043708|NCT00255554|Behavioral|Dialectical Behavioral Therapy|
12043709|NCT00255554|Drug|Escitalopram|
12043710|NCT00255541|Drug|Tesaglitazar|
12043711|NCT00255541|Drug|Glibenclamide|
12043712|NCT00255528|Drug|metoprolol succinate|
12043713|NCT00255515|Drug|Quetiapine fumarate|oral
12043714|NCT00255515|Drug|conventional treatment for schizophrenia|various standard therapies
12043715|NCT00255502|Drug|metoprolol succinate|
12043716|NCT00255489|Drug|Gefitinib|
12043717|NCT00255489|Procedure|palliative thoracic radiotherapy|
12043718|NCT00255476|Drug|gefitinib|
12043719|NCT00255476|Drug|cisplatin|
12043720|NCT00255476|Drug|5-flourouracil|
12043721|NCT00255463|Drug|Anastrazole|
12043722|NCT00255463|Drug|Gefitinib|
12043723|NCT00255450|Drug|ferumoxytol or placebo|
12043724|NCT00255437|Drug|ferumoxytol or oral iron|
12043725|NCT00255424|Drug|ferumoxytol or oral iron|
12043726|NCT00255385|Drug|Micronutrient (Zinc and Iron) fortification|
12043727|NCT00255385|Drug|Pre and Probiotic fortification|
12043728|NCT00255372|Drug|PEG 4000 (Forlax®)|Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
12043729|NCT00255372|Drug|Lactulose active and Lactulose placebo|Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.
12043730|NCT00255359|Drug|XTL-2125|
12043731|NCT00255346|Drug|Dasatinib (BMS-354825)|70 mg orally twice daily
12043732|NCT00255333|Drug|INNO-105|
12043733|NCT00255320|Drug|VIP|
12043734|NCT00255307|Drug|CVT-E002 ginseng extract|
12043735|NCT00255294|Drug|Cellulose sulfate vaginal gel|
12043736|NCT00255281|Drug|AZD7009, no generic name available|
12043737|NCT00255268|Drug|Goserelin|
12043738|NCT00255268|Drug|Bicalutamide|
12043739|NCT00255255|Drug|Budesonide/Formoterol|
12043740|NCT00255242|Drug|Simvastatin treatment for 28 days|40 mg / day
12043741|NCT00255229|Drug|Glutamine|Glutamine 10 g four times daily starting two days before treatment for six days in total
12043742|NCT00255229|Other|Placebo|Glutamine placebo
12043743|NCT00255216|Drug|Policosanol supplement (oral capsule) vs. placebo|
12043744|NCT00255190|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
12043745|NCT00255190|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
12043746|NCT00255177|Drug|VGX-410 (Mifepristone)|VGX-410 tablets taken daily or twice daily for 28 days
12043747|NCT00255177|Drug|Placebo|Placebo for VGX-410 tablets taken daily or twice daily for 28 days
12043748|NCT00255164|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
12043749|NCT00255164|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
12043750|NCT00255164|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
12043751|NCT00255151|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
12043752|NCT00255151|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
12043753|NCT00255151|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
12043754|NCT00255138|Drug|Atomoxetine|
12043990|NCT00253526|Procedure|chemotherapy|
12043991|NCT00253526|Procedure|conventional surgery|
12043756|NCT00255125|Drug|Placebo|Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
12043757|NCT00255112|Behavioral|family based cognitive behavior therapy|newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old
12043758|NCT00255099|Drug|TMC125|2 x 100 mg tablets b.i.d. / 96 weeks
12043759|NCT00255099|Drug|Placebo|2 tablets b.i.d. / 96 weeks
12043760|NCT00255086|Drug|Memantine|10mg Memantine
12043761|NCT00255086|Drug|Placebo pill|10mg placebo pill
12043762|NCT00255073|Drug|baclofen|
12043763|NCT00255047|Biological|DAPTACEL®. (DTaP), IPOL®., and ActHIB®.|0.5 mL, Intramuscular
12043764|NCT00255047|Biological|Pentacel®: DTaP-IPV/Hib combined|0.5 mL, Intramuscular
12043765|NCT00255047|Biological|DTaP-IPV and ActHIB®|0.5 mL, Intramuscular
12043766|NCT00255047|Biological|Pentacel®: DTaP-IPV/Hib combined|0.5 mL, Intramuscular
12043767|NCT00255034|Biological|Peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
12043768|NCT00255034|Biological|Peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
12043769|NCT00255034|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks
12043770|NCT00255034|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks
12043771|NCT00255021|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac|0.5 mL, IM
12043772|NCT00255008|Biological|peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
12043773|NCT00255008|Drug|ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks
12043774|NCT00255008|Biological|peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
12043775|NCT00255008|Drug|ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks
12043776|NCT00254995|Biological|None administered in this study|N/A in this study
12043777|NCT00254982|Biological|Infliximab|Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
12043778|NCT00254969|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib|0.5 mL, Im
12043779|NCT00254956|Drug|ciclesonide (XRP1526)|
12043780|NCT00254930|Drug|risperidone|
12043781|NCT00254917|Biological|Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine|0.5 mL, IM
12043782|NCT00254917|Biological|Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine|0.5 mL, IM
12043783|NCT00254904|Drug|Cisplatin|Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
12043784|NCT00254904|Drug|Gemcitabine|Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
12043785|NCT00254904|Drug|PF-3512676|PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
12043786|NCT00254904|Drug|Cisplatin|Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
12043787|NCT00254904|Drug|Gemcitabine + Cisplatin|Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
12043788|NCT00254891|Drug|PF-3512676 + Paclitaxel + Carboplatin|"PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity.
~Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
~Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles."
12043789|NCT00254891|Drug|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
~Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles."
12043790|NCT00254878|Drug|Methylphenidate hydrochloride|
12043791|NCT00254865|Drug|EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.75 mg of ethinyl estradiol (versus CILEST® tablets).|
12043792|NCT00254852|Procedure|Posterior Lateral Fusion (PLF)|Posterior lateral fusion (PLF) of the lumbar spine
12043793|NCT00254852|Procedure|Anterior Lumbar Interbody Fusion (ALIF)|Anterior lumbar interbody fusion (ALIF)
12043794|NCT00254852|Procedure|Transforaminal lumbar interbody fusion (TLIF)|Transforaminal lumbar interbody fusion (TLIF)
12043795|NCT00254852|Procedure|Posterior lumbar interbody fusion (PLIF)|Posterior lumbar interbody fusion (PLIF)
12043796|NCT00254852|Procedure|Extreme lateral interbody fusion (XLIF)|Extreme lateral interbody fusion (XLIF)
12043797|NCT00254826|Biological|YF-VAX® plus saline|YF-VAX® plus saine
12043798|NCT00254826|Biological|17D YF Vaccine plus Ig,|17D YF Vaccine plus Ig, one vaccine on day 0
12043799|NCT00254813|Drug|Quetiapine|
12043800|NCT00254800|Drug|ethinyl estradiol and levonorgestrel; exenatide|Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
12043801|NCT00254800|Drug|ethinyl estradiol and levonorgestrel; exenatide|Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
12043802|NCT00254800|Drug|ethinyl estradiol and levonorgestrel; exenatide|Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
12043803|NCT00254787|Drug|IR (Immediate-Release) quetiapine fumarate (drug)|
12043804|NCT00254774|Drug|quetiapine fumarate or valproate|
12043805|NCT00254761|Drug|Cannabis|
12043806|NCT00254748|Drug|Quetiapine fumarate|flexible doses from 200 mg to 600 mg
12043807|NCT00254748|Drug|Placebo|placebo
12043808|NCT00254735|Drug|quetiapine fumarate|
12043809|NCT00254735|Drug|SSRI/Clomipramine|
12043810|NCT00254722|Drug|Autologous bone marrow precursor cell harvest and transplant|Bone marrow harvest (3 ml/kg of body weight) performed between 12 and 30 hours post injury, followed by single intravenous infusion of bone marrow progenitor cells - target dose is 6x10^6 mononuclear cells/kg body weight, administered within 36 hours of injury
12043811|NCT00254709|Drug|Sirolimus|
12043812|NCT00254696|Drug|Extended-Spectrum-Lactamases (ESBLs)|
12043813|NCT00254683|Device|PET/CT with FDG|PET/CT before start of neoadjuvant CRT, at 6 weeks, 12 weeks, following CRT completion and 12mo, 24mo following CRT for those considered complete responders
12043814|NCT00254670|Drug|Naltrexone|
12043815|NCT00254657|Drug|Levetiracetam|Started with one 500 mg tablet/day and titrated upward as tolerated over 6 weeks by 500 mg/week to a maximum dose of 3000 mg/day.
12043816|NCT00254657|Drug|Placebo|
12043817|NCT00254644|Procedure|Morphological and functional MRI|one time
12043818|NCT00254631|Drug|Oxycodone hydrochloride|
12043819|NCT00254618|Drug|mesalamine|oral tablet, 30 mg mesalamine/day for 28 days
12043820|NCT00254618|Drug|mesalamine|oral tablet, 60 mg mesalamine/day for 28 days
12043821|NCT00254618|Drug|mesalamine|oral tablet, 90 mg mesalamine/day for 28 days
12043822|NCT00254592|Drug|Doxorubicin|60 mg/m2 IV, bolus once a day every 14 days x 2-4 cycles
12043823|NCT00254592|Drug|Cyclophosphamide|600 mg/m2 IV once a day every 14 days x 2-4 cycles
12043824|NCT00254592|Drug|Carboplatin|AUC 2 IV weekly for 9-12 doses beginning two weeks after completion of last AC dose
12043825|NCT00254592|Drug|Nab-paclitaxel|100 mg/m2 IV over 30 min weekly for 9-12 doses beginning two weeks after completion of last AC dose
12043826|NCT00254592|Drug|GM-CSF|250 μg/mL IV or on day 4-13 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
12043827|NCT00254592|Drug|Trastuzumab|4mg/kg, and then2 mg/kg q wk IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
12043828|NCT00254592|Drug|Bevacizumab|10mg/kg q 2 wks
12043829|NCT00254579|Drug|CP-675,206|15 mg/kg Q12W dosing regimen
12043830|NCT00254566|Other|Moxifloxacin Placebo|1 capsule once daily for 5 days
12043831|NCT00254566|Drug|Moxifloxacin|1 X 400mg capsule once daily for 5 days
12043832|NCT00254566|Other|Azithromycin SR Placebo|single dose, oral.
12043833|NCT00254566|Drug|Azithromycin SR|single dose 2.0 g oral
12043834|NCT00254553|Drug|Testim 1% (testosterone gel)|Testim_ 100 mg: two tubes of 50 mg of Testim_per day
12043835|NCT00254553|Drug|Placebo|two tubes of placebo per day
12043836|NCT00254540|Drug|SU011248 capsule|50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops
12043837|NCT00254514|Drug|somatropin|
12043838|NCT00254501|Behavioral|Pharmacist Counseling|Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
12043839|NCT00254501|Behavioral|Educational materials|Patients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care.
12043840|NCT00254488|Drug|Lithium (LI)|The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).
12043841|NCT00254488|Drug|Divalproex (DV)|Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).
12043842|NCT00254475|Drug|simvastatin|
12043843|NCT00254475|Drug|valsartan|
12043844|NCT00254462|Drug|Atomoxetine|Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.
12043845|NCT00254462|Drug|Placebo|Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
12043846|NCT00254462|Behavioral|Parent Training|All children will receive parent training for the duration of the study.
12043847|NCT00254449|Drug|NGX-4010|
12043848|NCT00254436|Drug|Procrit (epoetin alfa)|Weekly dose
12043849|NCT00254423|Drug|Dasatinib|Given PO
12043850|NCT00254423|Other|Laboratory Biomarker Analysis|Correlative studies
12043851|NCT00254423|Other|Pharmacological Study|Correlative studies
12043852|NCT00254423|Other|Quality-of-Life Assessment|Ancillary studies
12043853|NCT00254423|Other|Questionnaire Administration|Ancillary studies
12043854|NCT00254410|Drug|Fludarabine|Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6
12043855|NCT00254410|Drug|Cyclophosphamide|Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6.
12043856|NCT00254410|Drug|Mitoxantrone|Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6.
12043857|NCT00254410|Drug|Rituximab|Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6.
12043858|NCT00254410|Drug|Filgrastim|Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
12043859|NCT00254397|Drug|Leuprolide|A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections).
12043860|NCT00254397|Biological|GP100: 209-217(210M) Peptide|1.0 ml subcutaneous injection in extremities.
12043861|NCT00254397|Biological|MAGE-3 Peptide|1.0 ml subcutaneous injection in extremities.
12043862|NCT00254384|Drug|Cisplatin|Given IV
12043863|NCT00254384|Drug|Docetaxel|Given IV
12043864|NCT00254384|Drug|Erlotinib|Given PO
12043865|NCT00254384|Drug|Erlotinib Hydrochloride|Given PO
12043866|NCT00254384|Other|Laboratory Biomarker Analysis|Correlative studies
12043867|NCT00254371|Procedure|Androgen Replacement|
12043868|NCT00254345|Procedure|coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin|
12043869|NCT00254319|Drug|Avastin, Alimta|
12043870|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC Solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
12044002|NCT00253487|Drug|busulfan|
12043871|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC Solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
12043872|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
12043873|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
12043874|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
12043875|NCT00254293|Drug|Abatacept|Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly
12043876|NCT00254280|Procedure|Intense Pulsed Light + paring versus paring alone|
12043877|NCT00254267|Drug|AMG 706|AMG 706 125mg, oral, once a day
12043878|NCT00254254|Drug|Exenatide - Exenatide - Placebo|Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections.
12043879|NCT00254254|Drug|Exenatide - Placebo - Exenatide|Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
12043880|NCT00254254|Drug|Placebo - Exenatide - Exenatide|Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
12043881|NCT00254241|Drug|Seroquel and Risperidone|
12043882|NCT00254228|Device|Electrotactile sensory substitution|
12043883|NCT00254215|Behavioral|high protein & low glycemic index diets|
12043884|NCT00254202|Drug|iloperidone|
12043885|NCT00254202|Drug|active comparator|
12043886|NCT00254202|Drug|placebo|
12043887|NCT00254189|Drug|Levonorgestrel|
12043888|NCT00254189|Drug|Ethinyl Estradiol|
12043889|NCT00254176|Dietary Supplement|Parenteral cysteine-HCl supplementation|cysteine-HCl supplementation 121 mg per kg per day
12043890|NCT00254176|Dietary Supplement|Placebo - added premasol|Premasol 121 mg per kg per day
12043891|NCT00254163|Drug|Fludarabine|
12043892|NCT00254163|Drug|Cyclophosphamide|
12043893|NCT00254163|Drug|Rituximab|
12043894|NCT00254163|Drug|Pentostatin|
12043895|NCT00254150|Procedure|Increase oxygen extraction rate|
12043896|NCT00254137|Drug|capecitabine|
12043897|NCT00254137|Drug|irinotecan|
12043898|NCT00254137|Drug|oxaliplatin|
12043899|NCT00254137|Drug|cetuximab|
12043900|NCT00254124|Device|The Diet Plate (R) TM portion control plate and bowl|
12043901|NCT00254111|Device|Ultra Probe Laser System|
12043902|NCT00254085|Drug|Insulin Aspart|
12043903|NCT00254072|Procedure|3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass|The procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy.
12043904|NCT00254059|Procedure|Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography|
12043905|NCT00254046|Drug|TMC125|2 X100 mg tablets b.i.d.96 weeks
12043906|NCT00254046|Drug|Placebo|2 tablets b.i.d.96 weeks
12043907|NCT00254033|Drug|Dextroamphetamine|
12043908|NCT00254033|Drug|Methylphenidate|
12043909|NCT00254020|Drug|Citalopram|Patients who are found to have major depression will be referred to a psychologist
12043910|NCT00254007|Drug|citalopram (celexa)|20(1 tablet)-50(2 1/2 tablets) mg/day for a period of 6 or 10 weeks
12043911|NCT00253994|Procedure|Acupuncture|
12043912|NCT00253981|Device|Monochromatic Near-Infrared Light Energy (MIRE)|Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.
12043913|NCT00253968|Drug|Eplivanserin|oral administration
12043914|NCT00253968|Drug|placebo|oral administration
12043915|NCT00253955|Drug|Levofloxacin|
12043916|NCT00253955|Drug|Piperacillin/Tazobactam|
12043917|NCT00253942|Procedure|Injecting bee venom as a treatment for OA|
12043918|NCT00253929|Drug|Intra-arterial infusion of adenosine|
12043919|NCT00253929|Drug|intra-arterial infusion of caffeine|
12043920|NCT00253929|Drug|intra-arterial infusion of acetylcholine|
12043921|NCT00253929|Drug|intra-arterial infusion of sodium nitroprusside|
12043922|NCT00253929|Procedure|Occlusion of arm-circulation by inflation of upper-arm cuff to 200mmHg for 2, 5 and 13 minutes|
12043923|NCT00253916|Behavioral|Aerobic cardiovascular exercise program|Aerobic cardiovascular exercise program
12043924|NCT00253916|Behavioral|Resistance Exercise Program|Resistance Exercise Program
12043925|NCT00253903|Drug|eplivanserin (SR46349)|oral administration
12043926|NCT00253903|Drug|placebo|oral administration
12043927|NCT00253890|Drug|Trazodone|50 mg 1-3 capsules at bedtime for 3 months
12043928|NCT00253890|Drug|Placebo|1-3 at bedtime
12043929|NCT00253877|Other|Complication rate|All patients in the active comparator group received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology. The complication rate and clinical efficacy will be recorded and compared to the Total Hip Replacement historical control group.
12043992|NCT00253526|Procedure|growth factor antagonist therapy|
12043993|NCT00253526|Procedure|monoclonal antibody therapy|
12043994|NCT00253526|Procedure|surgery|
12043995|NCT00253513|Drug|fludarabine|30 mg/m2, IV for 5 days
12043996|NCT00253513|Drug|treosulfan|12 or 14 g/m2, IV for 5 days
12043997|NCT00253513|Procedure|allogeneic blood or bone marrow transplantation|bone marrow or peripheral blood stem cells
12043998|NCT00253500|Biological|pegfilgrastim|6 mg in a syringe
12043930|NCT00253851|Drug|unfractionated heparin|Five minutes prior to tourniquet inflation, patients will receive 0.1 ml/kg/minute of intravenous (IV) unfractionated heparin (1000 units/ml) or placebo (normal saline solution). Five minutes will be allowed to elapse to ensure complete systemic heparinization. The operated limb will then be elevated and exsanguinated using an Esmarch bandage. Following cuff inflation, the contents of a second syringe will be administered IV over a 5 minute period. The second syringe will contain either protamine sulfate (1.0 mg/kg) to reverse the systemic heparin for patients in the treatment group, or normal saline for the control group. Study drugs will be administered by the anaesthesiologist via a peripheral IV. This new method of intraoperative regional heparinization has been used in two previous studies (Giachino et al., 2001; Giachino et al., 1985) with no adverse effects noted.
12043931|NCT00253838|Procedure|Restoration HA stem|The Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surfacing and allows for a hydroxylapatite (HA) coating to be applied to the entire length of the stem.
12043932|NCT00253838|Procedure|Solution stem|The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
12043933|NCT00253825|Device|mCIMT combined with or without eye patching|
12043934|NCT00253812|Procedure|flexible sigmoidoscopy|
12043935|NCT00253799|Device|Hylan GF-20|
12043936|NCT00253786|Other|Intensive multifactorial therapy|Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care
12043937|NCT00253786|Other|Standard therapy|Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)
12043938|NCT00253773|Drug|acetominophen, sulfer amino acids; cysteine and methionine|
12043939|NCT00253760|Drug|dietary amino acids; cysteine and methionine|
12043940|NCT00253747|Drug|Osmotic-Release Methylphenidate|OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
12043941|NCT00253747|Drug|Placebo|OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
12043942|NCT00253734|Biological|Fluzone® (IM)|15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.
12043943|NCT00253734|Biological|Fluzone®|9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).
12043944|NCT00253721|Drug|Melphalan|"All levels: Every 4 weeks for up to one year
~Dose Escalation Plan:
~Level 1: 4mg/m2/day x 2 days
~Level 2: 6mg/m2/day x 2 days
~Level 3: 8mg/m2/day x 2 days
~Level 4: 10mg/m2/day x 2 days
~Level 5: 12mg/m2/day x 2 days"
12043945|NCT00253708|Procedure|management of therapy complications|
12043946|NCT00253708|Procedure|massage therapy|
12043947|NCT00253708|Procedure|pain therapy|
12043948|NCT00253708|Procedure|psychosocial assessment and care|
12043949|NCT00253708|Procedure|quality-of-life assessment|
12043950|NCT00253695|Device|Wrist Actigraphy|Wrist actigraph will record participants' sleeping patterns.
12043951|NCT00253669|Other|laboratory biomarker analysis|
12043952|NCT00253669|Other|physiologic testing|
12043953|NCT00253669|Procedure|management of therapy complications|
12043954|NCT00253643|Dietary Supplement|green tea catechin extract|Given orally 2 times/day
12043955|NCT00253643|Dietary Supplement|fish oil|Given orally 3 times/day
12043956|NCT00253643|Other|placebo|Given olive oil placebo orally 3 times/day
12043957|NCT00253643|Other|placebo|Given green tea placebo orally 2 times/day
12043958|NCT00253630|Other|Laboratory Biomarker Analysis|Correlative studies
12043959|NCT00253630|Drug|Vorinostat|Given PO
12043960|NCT00253617|Drug|porfimer sodium|
12043961|NCT00253617|Procedure|adjuvant therapy|
12043962|NCT00253617|Procedure|laser therapy|
12043963|NCT00253617|Procedure|photodynamic therapy|
12043964|NCT00253617|Procedure|phototherapy|
12043965|NCT00253591|Drug|cisplatin|
12043966|NCT00253591|Drug|vinorelbine tartrate|
12043967|NCT00253591|Radiation|radiation therapy|
12043968|NCT00253578|Drug|sorafenib tosylate|Given PO
12043969|NCT00253578|Other|laboratory biomarker analysis|Correlative studies
12043970|NCT00253565|Drug|capecitabine|
12043971|NCT00253565|Drug|imatinib mesylate|
12043972|NCT00253552|Biological|filgrastim|
12043973|NCT00253552|Drug|busulfan|
12043974|NCT00253552|Drug|cyclophosphamide|
12043975|NCT00253552|Drug|cyclosporine|
12043976|NCT00253552|Drug|etoposide|
12043977|NCT00253552|Drug|methotrexate|
12043978|NCT00253552|Procedure|allogeneic bone marrow transplantation|
12043979|NCT00253552|Radiation|radiation therapy|
12043980|NCT00253539|Drug|arzoxifene hydrochloride|Given orally
12043981|NCT00253539|Drug|tamoxifen citrate|Given orally
12043982|NCT00253539|Other|placebo|Given orally
12043983|NCT00253526|Drug|bevacizumab|
12043984|NCT00253526|Drug|gemcitabine hydrochloride|
12043985|NCT00253526|Procedure|adjuvant therapy|
12043986|NCT00253526|Procedure|anti-cytokine therapy|
12043987|NCT00253526|Procedure|antiangiogenesis therapy|
12043988|NCT00253526|Procedure|antibody therapy|
12043989|NCT00253526|Procedure|biological therapy|
12044004|NCT00253487|Procedure|adjuvant therapy|
12044005|NCT00253487|Procedure|autologous bone marrow transplantation|
12044006|NCT00253487|Procedure|conventional surgery|
12044007|NCT00253487|Procedure|peripheral blood stem cell transplantation|
12044008|NCT00253487|Radiation|radiation therapy|
12044009|NCT00253474|Biological|PEG-interferon alfa-2a|
12044010|NCT00253461|Procedure|computed tomography|Within 4 weeks after initial imaging, patients also undergo a CT scan.
12044011|NCT00253461|Procedure|positron emission tomography|"Phase I: IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan.
~Phase II: fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan."
12044012|NCT00253461|Radiation|11C topotecan|Phase I and II: IV over 10 minutes
12044013|NCT00253461|Radiation|fludeoxyglucose F 18|Phase II: fludeoxyglucose F 18 IV
12044014|NCT00253448|Radiation|radiation therapy|No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
12044015|NCT00253448|Radiation|stereotactic radiosurgery|stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy
12044016|NCT00253435|Biological|Filgrastim|Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. The first dose should begin four hours after the stem cell infusion is completed. Filgrastim will continue daily until the ANC >=1500/uL for three consecutive days.
12044017|NCT00253435|Drug|Carboplatin|"The carboplatin will be administered as a continuous IV infusion Day - 7 through Day - 4, with dosing based upon pretreatment GFR levels. The carboplatin should be diluted to a concentration of 0.3 mg/ml in D5W 0.45NS and infused concomitantly with etoposide through the same central venous catheter using a Y connector; a controlled rate infusion pump is used for each arm of the Y."
12044018|NCT00253435|Drug|Etoposide|The etoposide shall be administered day -7 through day -4 via continuous intravenous infusion over 96 hours. For patients with a corrected GFR >= 100 ml/min/1.72 m^2, a dose of 300 mg/m^2/day (10 mg/kg/day if child is < 12 kg) shall be given. For patients with a corrected GFR 60-99 ml/min/1.72 m^2, the etoposide will be administered at a dose of 160 mg/m^2/day (5.3 mg/kg/day). The etoposide will be diluted in D5W 0.45%NS at a concentration of < 0.4 mg/ml. Etoposide should not be mixed with carboplatin, but administered using a Y-connector.
12044019|NCT00253435|Drug|Melphalan|For patients in either the normal GFR strata (>=100 ml/min/1.73 m^2), or reduced GFR strata (60-99 ml/min/1.73m^2), melphalan shall be administered at a dose of 60 mg/m^2/day (2 mg/kg/day if child is < 12 kg) on day -7, -6, and -5 of study. The melphalan should be infused at a rate of less than 10 mg/minute, and should complete within 1 hour of reconstitution each day. The melphalan should be diluted in 0.9% NaCl at a concentration < 2 mg/ml. The total dosage of melphalan to be administered will be 180 mg/m^2.
12044020|NCT00253435|Procedure|Peripheral blood stem cell infusion|Stem cells or marrow will be infused on day 0 of study therapy. Where the DMSO concentration in the stem cell product would exceed accepted level for infusion within a 24 hour period, stem cell products may be infused over two days to meet this standard. For purged PBSC: A minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. For unpurged PBSC, a minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. Having a back-up of 2.0 x 10^6 viable CD34+ cells/kg purged or unpurged PBSC is recommended but not required. For purged bone marrow, a minimum of 1.5 x10^8 mononuclear cells/kg must be available.
12044021|NCT00253435|Radiation|131I-MIBG|Therapeutic 131I MIBG will be synthesized by Draximage Canada.with specific activity between 15 and 25mCi/ml. Radiopurity will be initially determined by Draximage, prior to shipment to participating centers. Free radioiodide content must then be rechecked at the treating center prior to infusion using HPLC or Sep-Pac methodology.
12044022|NCT00253435|Radiation|Radiation therapy|Local irradiation is to be given to previously non-irradiated primary and metastatic sites of disease. Local irradiation should not start till the patient is medically stable, has an ANC > 1000/uL, platelets > 30,000 / uL, and is > 42 days post transplant. Recommended radiation guidelines consist of 2160 cGy total, given over 12 days using a single 180 cGy fraction/day. Any delay in local radiation that would extend treatment beyond day +84 should be discussed with the study chair. Local radiation will be administered at a participating NANT member site.
12044023|NCT00253422|Drug|anastrozole|
12044024|NCT00253422|Drug|exemestane|
12044025|NCT00253422|Drug|fulvestrant|
12044026|NCT00253409|Drug|chemotherapy|
12044027|NCT00253409|Procedure|adjuvant therapy|
12044028|NCT00253409|Procedure|conventional surgery|
12044029|NCT00253409|Procedure|neoadjuvant therapy|
12044030|NCT00253409|Radiation|radiation therapy|
12044031|NCT00253396|Drug|Unfractionated heparin|
12044032|NCT00253396|Drug|Enoxaparin|
12044033|NCT00253383|Other|counseling intervention|
12044034|NCT00253383|Other|educational intervention|
12044035|NCT00253383|Procedure|psychosocial assessment and care|
12044036|NCT00253383|Procedure|quality-of-life assessment|
12044037|NCT00253370|Drug|BAY 43-9006|Given orally
12044038|NCT00253370|Drug|docetaxel|Given IV
12044039|NCT00253370|Drug|cisplatin|Given IV
12044040|NCT00253344|Drug|docetaxel|Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
12044041|NCT00253344|Drug|lenalidomide|Oral lenalidomide on days 1-14. Courses repeat every 21 days until disease progression or unacceptable toxicity.
12044042|NCT00253331|Drug|topical organogel with nitroglycerin|
12044043|NCT00253318|Drug|Docetaxel|40 mg/m^2 IV over 1 hour on Day 1.
12044044|NCT00253318|Drug|RAD001|30 mg orally on Days 1 and 8.
12044045|NCT00253318|Drug|Dexamethasone|8 mg orally twice daily for 3 days, starting 24 hours prior to the administration of Docetaxel.
12044046|NCT00253305|Drug|Organogel of naftifine, 2%|
12044047|NCT00253305|Drug|Organogel of terbinafine, 2%|
12044048|NCT00253305|Drug|Organogel of naftifine, 6%|
12044049|NCT00253305|Drug|Organogel of terbinafine, 6%|
12044050|NCT00253279|Procedure|PET Scans|Healthy volunteers will undergo one PET Scan; bur patients will undergo a maximum of 3 PET scans over 2 years after injury; a maximum of 2 will be done while inpatient; one after d/c.
12044051|NCT00253266|Drug|Venlafaxine|Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
12044052|NCT00253266|Drug|Quetiapine|Quetiapine up to 200 mg/d for four weeks
12044055|NCT00253227|Drug|galantamine hydrobromide|
12044056|NCT00253214|Drug|galantamine hydrobromide|
12044057|NCT00253201|Drug|galantamine hydrobromide|
12044058|NCT00253188|Drug|galantamine hydrobromide|
12044059|NCT00253175|Drug|topiramate|
12044060|NCT00253162|Drug|risperidone|
12044061|NCT00253149|Drug|risperidone|
12044062|NCT00253136|Drug|risperidone|
12044063|NCT00253123|Drug|risperidone|
12044064|NCT00253110|Drug|risperidone|
12044065|NCT00253110|Drug|haloperidol|
12044066|NCT00253097|Behavioral|Intervention|Patients allocated to the intervention group have 4 visits by a study nurse. She will measure patient's blood pressure (BP) by standardized meathods, inform the patient about the target BP, stress the importance of lowering the BP and in case of elevated BP she advices the patient to go the the GP for further control. She advises about smoking cessation, reduction of alcohol consumption, loss of excess body weigt and stresses the importance of physical activity as appropriate
12044067|NCT00253084|Drug|IPX054 200 mg|IPX054 containing 50 mg carbidopa and 200 mg levodopa
12044068|NCT00253084|Drug|CD-LD IR|CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
12044069|NCT00253084|Drug|IPX054 Placebo|Placebo to match IPX054 200 mg
12044070|NCT00253084|Drug|CD-LD IR Placebo|Placebo to match CD-LD IR
12044071|NCT00253071|Behavioral|Prophylactic combined medical and psychological treatment|"Medical treatment is naturalistic and evidence based according to international recommendations.
~Psychological treatment is either group psychoeducation or group cognitive behavioural therapy."
12044072|NCT00253058|Drug|Cetirizine Dry Syrup|
12044073|NCT00253045|Behavioral|Motivational groups|Motivational interviewing in group format
12044074|NCT00253032|Device|PRIMA|
12044075|NCT00253006|Procedure|Tissue examination for protein- and mRNA-expression of NO|
12044076|NCT00252993|Drug|DDP225|
12044077|NCT00252980|Behavioral|Psychotherapy|
12044078|NCT00252967|Drug|Atorvastatin|80 mg of Atorvastatin
12044079|NCT00252967|Drug|Placebo|
12044080|NCT00252954|Drug|Levetiracetam|Tablets 2000-3000 mg per day
12044081|NCT00252941|Device|Memokath 028SW Urethral Stent|
12044082|NCT00252928|Other|Sodium dichloroisocyanurate (NaDCC) tablets|Intervention arm receives NaDCC tablets to use for to disinfect their household water for use for 20L of water. Ideally, disinfection occurs every day.
12044083|NCT00252928|Other|Placebo|Placebo
12044084|NCT00252915|Biological|GM-CSF (verum)|sagramostim
12044085|NCT00252902|Behavioral|Behavior change counseling|
12044086|NCT00252889|Drug|Topotecan and pegylated doxorubicin|Doxil 40 mg/m2 day 1 and topotecan was to be escalated in cohorts of patients
12044087|NCT00252876|Drug|tesaglitazar|
12044088|NCT00252863|Drug|Symbicort, used twice daily (b.i.d) and as needed (prn)|
12044089|NCT00252863|Drug|Budesonide Turbuhaler 200 µg|
12044090|NCT00252863|Drug|Fluticasone Discus 250 µg|
12044091|NCT00252863|Drug|Formoterol Turbuhaler 4.5 µg|
12044092|NCT00252863|Drug|Terbutaline Turbuhaler 0.5 mg|
12044093|NCT00252863|Drug|Salbutamol pressurized metered dose inhaler (pMDI) 100 µg|
12044094|NCT00252863|Drug|Salmeterol Discus 50 µg|
12044095|NCT00252863|Drug|Budesonide/Formoterol Turbuhaler 160/4.5 µg|
12044096|NCT00252863|Drug|Fluticasone/Salmeterol Discus 250/50 µg|
12044097|NCT00252863|Drug|Fluticasone/Salmeterol Discus 500/50 µg|
12044098|NCT00252863|Drug|Theophylline 200 mg|
12044099|NCT00252863|Drug|Theophylline 300 mg|
12044100|NCT00252863|Drug|Singulair 10 mg|
12044101|NCT00252850|Genetic|CERE-120: AAV2-NTN|
12044102|NCT00252837|Drug|Tesaglitazar|
12044103|NCT00252837|Behavioral|Dietary and Lifestyle counseling|
12044104|NCT00252824|Drug|Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy|
12044105|NCT00252811|Drug|Gefitinib|
12044106|NCT00252798|Drug|Gefitinib|
12044107|NCT00252798|Drug|Carboplatin|
12044108|NCT00252798|Drug|Paclitaxel|
12044109|NCT00252798|Procedure|Radiation|
12044110|NCT00252785|Drug|Budesonide/Formoterol|
12044111|NCT00252785|Drug|Budesonide|
12044112|NCT00252785|Drug|Theophylline|
12044113|NCT00252772|Drug|Tesaglitazar|
12044114|NCT00252772|Behavioral|Dietary and Lifestyle counseling|
12044115|NCT00252746|Drug|ZD6474 (vandetanib) 100mg|once daily oral dose
12044116|NCT00252746|Drug|ZD6474 (vandetanib) 200mg|once daily oral dose
12044117|NCT00252746|Drug|ZD6474 (vandetanib) 300mg|once daily oral dose
12044118|NCT00252733|Drug|candesartan cilexetil|32 mg once daily oral tablet given over 60 months
12044119|NCT00252720|Drug|candesartan|32 mg oral tablet
12044120|NCT00252707|Drug|Gefitinib or Docetaxel|
12044121|NCT00252694|Drug|candesartan|32 mg oral tablet
12044122|NCT00252681|Procedure|laparotomy|
12044123|NCT00252681|Procedure|primary peritoneal drainage|
12044124|NCT00252668|Drug|Etanercept|
12044125|NCT00252668|Drug|Methotrexate|
12044126|NCT00252655|Drug|Rapamune and Prograf|
12044127|NCT00252642|Drug|Peginterferon Alpha-2a|
12044128|NCT00252629|Other|Nasal CPAP treatment during sleep|After documenting sleep disordered breathing, GWS subject gets randomized to receive either a therapeutic nasal CPAP or a sham nasal CPAP treatment during sleep, GWS symptoms ( fatigue, pain, and cognitive dysfunction) were assessed by a baseline questionnaires and at 3 week period whether on sham or therapeutic CPAP. The change of symptoms in each group will be compared.
12044129|NCT00252616|Behavioral|trophic enteral feeds|10cc/hr
12044130|NCT00252603|Drug|Galantamine|
12044131|NCT00252590|Behavioral|Health Motivational Feedback|Personalized feedback on health status
12044132|NCT00252590|Behavioral|Health Education|Generalized health education related to alcohol use
12044133|NCT00252590|Behavioral|Control - treatment as usual|Control group with no additional intervention
12044186|NCT00252148|Biological|ADMVA|experimental HIV vaccine, MVA vector expressing HIV clade C env, gag, pol, nef, and tat
12044187|NCT00252122|Drug|Ketamine|Ketamine. 0.2 mg/kg, intravenously
12044134|NCT00252577|Drug|Lithium treatment|Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years
12044135|NCT00252564|Drug|Bevacizumab|5 mg/kg over 30 minutes on Days 1 and 15
12044136|NCT00252564|Drug|Oxaliplatin|85 mg/m2 on Days 1 and 15
12044137|NCT00252564|Drug|Leucovorin|400 mg/m2 on Days 1 and 15
12044138|NCT00252564|Drug|Fluorouracil|400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)
12044139|NCT00252564|Drug|Cetuximab|400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour
12044140|NCT00252551|Procedure|Osteosynthesis|
12044141|NCT00252551|Procedure|Simple surgery|Surgery without device
12044142|NCT00252512|Behavioral|Contingency Management|Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
12044143|NCT00252512|Other|Placebo|Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
12044144|NCT00252499|Drug|rosiglitazone|PPAR-gamma agonist, insulin sensitizer
12044145|NCT00252499|Drug|fenofibrate|PPAR-alpha agonist, reduces triglycerides
12044146|NCT00252499|Drug|placebo for rosiglitazone|placebo tablets that are matched to look like rosiglitazone
12044147|NCT00252499|Drug|placebo for fenofibrate|placebo matched to look like fenofibrate tablets
12044148|NCT00252486|Drug|Flax oil|Flax oil and olive oil placebo were analyzed for quality and purity; sufficient bioactivity was confirmed for the flax oil independently at the University of Massachusetts mid-way through the study. Each capsule of omega -3 fatty acid concentrate contained 550 mg of α-linolenic acid (α-LNA) from flax seed oil.A stepped but flexible dose-titration schedule was carried out with doses increased by 1-2 grams at each visit as tolerated, to an attempted total dose of 6 capsules twice per day, as requested by the FDA (up to 6.6 grams of daily α-linolenic acid).
12044149|NCT00252473|Device|MedTec S-frame Immobilization Masks|
12044150|NCT00252460|Device|Computed Tomography Scan and Magnetic Resonance Imaging|
12044151|NCT00252447|Procedure|Pre-Operative Conformal Radiotherapy|
12044152|NCT00252434|Behavioral|Cognitive Behavioral Therapy Development for Methamphetamine Abuse|
12044153|NCT00252421|Drug|Nitroglycerin ointment 15 mg/day daily for 24 month|Nitroglycerin ointment 15 mg/day applied daily for 24 mth
12044154|NCT00252421|Drug|Placebo ointment daily for 24 month|Placebo ointment applied daily for 24 mth
12044155|NCT00252408|Drug|Hormone replacement therapy|
12044156|NCT00252395|Device|PDA-based Electronic Prescribing Software|
12044157|NCT00252382|Drug|SNS-595 Injection|Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.
12044158|NCT00252369|Drug|Infliximab|
12044159|NCT00252369|Procedure|Instillation of fibrin glue|
12044160|NCT00252356|Drug|SR58611A|
12044161|NCT00252343|Drug|SR58611A|
12044162|NCT00252330|Drug|SR58611A|
12044163|NCT00252317|Drug|Captopril and Trandolapril|Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
12044164|NCT00252317|Drug|Captopril Test Dose and Trandolapril|Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
12044165|NCT00252304|Drug|Zinc (zinc sulphate)|Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
12044166|NCT00252304|Drug|Placebo|Placebo
12044167|NCT00252291|Drug|Aridol|
12044168|NCT00252291|Drug|Methacholine|
12044169|NCT00252291|Procedure|Exercise challenge|
12044170|NCT00252278|Drug|atomoxetine|
12044171|NCT00252252|Device|VPAP non-invasive ventilator|
12044172|NCT00252252|Device|AutoVPAP non-invasive ventilator|
12044173|NCT00252239|Drug|tenecteplase|This study will compare 3 different doses of tenecteplase to tPA.
12044174|NCT00252239|Drug|tissue plasminogen activator, tPA|To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.
12044175|NCT00252226|Drug|Quetiapine|
12044176|NCT00252213|Drug|Human BNP|
12044177|NCT00252200|Drug|Neseritide|Dose of Nesiritide infusion will be 0.005 ug/Kg/min
12044178|NCT00252187|Drug|B-type Natriuretic Peptide (BNP)|BNP hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
12044179|NCT00252187|Other|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
12044180|NCT00252174|Drug|Stage 1 Active Methylenedioxymethamphetamine|"Dosage form: capsule
~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
12044181|NCT00252174|Drug|Stage 1 Low dose Methylenedioxymethamphetamine|"Drug:
~Dosage form: capsule
~Dosage frequency and duration for the control arm (4 subjects):
~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
12044182|NCT00252174|Behavioral|Psychotherapy|Psychotherapy conducted with low or active dose MDMA
12044183|NCT00252174|Drug|Stage 2 Active Methylenedioxymethamphetamine|"Administered open label Dosage form: capsule
~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
12044184|NCT00252161|Procedure|Gastrectomy with more than D2 dissection|Gastrectomy with more than D2 dissection
12044185|NCT00252161|Drug|Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy|Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
12044188|NCT00252109|Behavioral|Popular Opinion Leader|Popular opinion leaders of social networks are identified and attend 4 sessions to prepare them to have casual conversations with persons in the social networks that are meant to shift social norms to embrace safer behaviors (e.g., increased condom use, fewer sexual partners)
12044189|NCT00252096|Device|Nucleic acid amplification test|
12044190|NCT00252083|Behavioral|Popular Opinion Leader|
12044191|NCT00252070|Behavioral|Functional Exercise for People with Arthritis (FEPA)|
12044192|NCT00252057|Behavioral|Re-Engineered Hospital Discharge|"The Re-engineered Hospital Discharge (Project RED) intervention provides a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call after discharge by a clinical pharmacist."
12044193|NCT00252044|Drug|Pergolide|
12044194|NCT00252031|Behavioral|Dialectical Behavioral Therapy|
12044195|NCT00252018|Behavioral|Daily intake of broccoli sprouts|
12044196|NCT00252005|Drug|Apixaban|
12044197|NCT00251992|Drug|Esomeprazole|
12044198|NCT00251979|Drug|Esomeprazole|
12044199|NCT00251966|Drug|Esomeprazole|
12044200|NCT00251953|Drug|Tesaglitazar|
12044201|NCT00251953|Drug|Metformin|
12044202|NCT00251940|Drug|Tesaglitazar 0.5 or 1 mg|
12044203|NCT00251940|Drug|Glibenclamide 2.5, 5, 10 or 15 mg|
12044204|NCT00251927|Drug|esomeprazole|40 mg oral tablet administered daily
12044205|NCT00251927|Procedure|Laparoscopic fundoplication (surgery)|Surgery
12044206|NCT00251914|Drug|Esomeprazole|
12044207|NCT00251901|Drug|Esomeprazole|
12044208|NCT00251888|Drug|campto (irinotecan)|
12044209|NCT00251888|Drug|cisplatin (cisplatyl)|
12044210|NCT00251875|Device|online health information journal|
12044211|NCT00251862|Behavioral|Web-based decision aid plus personalized risk assessment|Patients review a computer-based decision aid that discuss the pros and cons of of 5 recommended CRC screening options and provides personalized 10-year estimates of CRC risk prior to meeting with their provider to discuss CRC screening.
12044212|NCT00251862|Behavioral|Web-based decision aid alone|Patients review a computer-based decision aid that discuss the pros and cons of the 5 recommended CRC screening options prior to meeting with their provider to discuss CRC screening.
12044213|NCT00251862|Behavioral|Generic website|Patients review a generic website that discuss ways to reduce overall cancer risk.
12044214|NCT00251849|Drug|Rifalazil|
12044215|NCT00251836|Procedure|Laparoscopic hand-assisted donor nephrectomy|
12044216|NCT00251823|Drug|Eptifibatide facilitated PCI|
12044217|NCT00251810|Device|Cerebral State Monitor|All patients monitored with BIS and CSM, results hidden for the anesthesiologist.
12044218|NCT00251797|Drug|Irinotecan|Irinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days
12044219|NCT00251797|Drug|Thalidomide|Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle
12044220|NCT00251784|Drug|Sildenafil|
12044221|NCT00251771|Procedure|catheter-directed venous thrombolysis|catheter-directed continuous intravenous infusion of alteplase 0.01mg/kg/h and low-dose heparin. Max dose 20mg/24 h and up to 96 hrs.
12044222|NCT00251758|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
12044223|NCT00251758|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
12044224|NCT00251758|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
12044225|NCT00251745|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
12044226|NCT00251745|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
12044227|NCT00251745|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
12044228|NCT00251732|Drug|Standard dose (once daily) PPI plus low-dose antidepressant|20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
12044229|NCT00251732|Drug|Double dose PPI plus evening placebo|20 mg. twice daily with a placebo
12044230|NCT00251732|Drug|Rabeprazole , placebo, placebo|20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
12044231|NCT00251719|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
12044232|NCT00251719|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
12044233|NCT00251719|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
12044234|NCT00251706|Drug|amiodarone|
12044235|NCT00251693|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
12044236|NCT00251693|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
12044237|NCT00251693|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
12044238|NCT00251680|Drug|Lapaquistat acetate and lipid-lowering therapy|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.
12044239|NCT00251680|Drug|Lipid-lowering therapy|Lapaquistat acetate placebo-matching tablets, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.
12044240|NCT00251654|Procedure|perineural block (anesthesia)|continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days
12044241|NCT00251641|Drug|infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
12044242|NCT00251641|Drug|methotrexate|Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
12044243|NCT00251628|Other|Standard Care|standard care
12044244|NCT00251628|Other|ATC Dosing|ATC dosing of a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours around-the-clock for the first 3 days following surgery
12044245|NCT00251628|Other|Structured Pain Management Program|The structured pain management program consisted of a nurse coaching intervention which included an evaluation of the child's current condition, review of the pain intensity scores, verification that the child was taking the pain medication, re-education regarding the rationale for ATC dosing, review of strategies to facilitate medication administration, and re-education about potential side effects associated with analgesic administration.
12044246|NCT00251628|Other|As needed dosing|"As needed analgesic dosing with a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours as needed for pain."
12044247|NCT00251602|Drug|Atropine|One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus
12044248|NCT00251602|Drug|Propranolol|One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
12044249|NCT00251602|Drug|Normal Saline|One-time 0.25 ml/min infusion over 30 minutes
12044250|NCT00251589|Drug|Vorinostat|Vorinostat 200 mg twice a day for 3 days a week.
12044251|NCT00251589|Drug|Vorinostat|Vorinostat 300 mg once a day for 3 days a week.
12044252|NCT00251589|Drug|Vorinostat|Vorinostat 300 mg twice a day for 3 days a week.
12044253|NCT00251589|Drug|Vorinostat|Vorinostat 400 mg once a day for 21 out of 28 days.
12044254|NCT00251589|Drug|erlotinib|erlotinib 150 mg once a day.
12044255|NCT00251576|Drug|A-Phase: tirofiban; Z-Phase simvastatin|
12044256|NCT00251576|Drug|Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years|
12044257|NCT00251576|Drug|Comparator: A-Phase: low molecular weight heparin, unfractionated heparin|
12044258|NCT00251576|Drug|Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hours|
12044259|NCT00251576|Drug|Duration of Treatment: Z-Phase, 2 years.|
12044260|NCT00251550|Drug|Pemetrexed|
12044261|NCT00251550|Drug|Cisplatin|
12044262|NCT00251537|Drug|LTB4|
12044263|NCT00251524|Drug|Bevacizumab, Oxaliplatin, Pemetrexed|Avastin 15 mg/kg IV, Alimta 500 mg/m2 IV given over 10 minutes, Eloxatin 120 mg/m2 IV given over 2 hours
12044264|NCT00251511|Drug|Arsenic Trioxide|
12044265|NCT00251498|Drug|Cetuximab|Cycle 1:400 mg/m2, administered as a 120-minute iv infusion on Day 1 and 250 mg/m2 administered as a 60-minute iv infusion on Days 8 and 15, subsequent cycles:250 mg/m2 administered as a 60-minute iv infusion on Days 1, 8, 15
12044266|NCT00251485|Drug|Cetuximab|Cycle 1: 400 mg/m2 (given as a 2-hour infusion) on Day 1, then 250 mg/m2, Day 8 (given as a 1-hour infusion) subsequent cycles:250 mg/m2, Day 1 and Day 8 (given as a 1-hour infusion)
12044267|NCT00251472|Drug|Paclitaxel Albumin Nanoparticle for Injectable Suspension|125mg/m2 by 30-minute IV infusion, once a week.
12044268|NCT00251459|Drug|rhuFab V2 (ranibizumab)|
12044269|NCT00251446|Drug|Vinflunine|320 mg/m2 as a 20-minute IV infusion
12044270|NCT00251433|Drug|lapatinib, docetaxel, trastuzumab|The phase I part of the study will include cohorts of 3 patients to investigate doses of lapatinib (750mg, 1000mg, 1250mg, 1500mg) with 75mg/m2 3- weekly docetaxel plus standard weekly doses of trastuzumab with prophylactic use of growth factors in all patients. Further cohorts may be explored with prophylactic use of growth factors at the doses stipulated in the phase I dose escalation schema
12044271|NCT00251433|Drug|Docetaxel, trastuzumab|For Phase II, subjects will be pre-stratified for Eastern Cooperative Oncology Group (ECOG) performance (0 vs. 1; see Appendix 4 ) and site of disease (visceral vs. non-visceral). Subjects will then be randomised in a 2:1 ratio to receive either the triplet regimen or the docetaxel and trastuzumab combination.
12044272|NCT00251420|Procedure|writing about disease|writing about physical or emotional consequences of pulmonary disease
12044273|NCT00251407|Drug|Taxotere|Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
12044274|NCT00251407|Drug|Cisplatin|Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
12044275|NCT00251407|Drug|CPT-11|Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
12044276|NCT00251394|Drug|Rituxan|Given intravenously once weekly for four weeks.
12044277|NCT00251394|Drug|1018 ISS|Given as an injection under the skin after the 2nd, 3rd and 4th rituxan infusion. One week after the last rituxan infusion is given, a fourth and final 1018ISS injection will be given.
12044278|NCT00251381|Drug|Cetuximab|
12044279|NCT00251368|Drug|9-Aminocamptothecin (9-AC)|
12044280|NCT00251355|Drug|Gemcitabine|Gemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy.
12044281|NCT00251355|Drug|5-Fluorouracil|5-FU via continuous IV infusion.
12044282|NCT00251355|Procedure|Radiation Therapy|External Beam Radiotherapy (weeks 1-6), Monday through Friday.
12044283|NCT00251342|Procedure|Edinburgh Postnatal Depression Scale|
12044284|NCT00251329|Drug|neoadjuvant chemotherapy|
12044285|NCT00251316|Drug|Lithium Carbonate|30 mCi of 131I
12044286|NCT00251316|Drug|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
12044287|NCT00251303|Drug|Riluzole|Active drug put into 10-mg capsules by NIH Clinical Center Pharmacy. Matched placebo capsules were also prepared by NIH Clinical Center Pharmacy. Dose up to 120 mg daily, divided into bid dosages.
12044288|NCT00251303|Drug|Placebo|Capsules matched active drug in appearance.
12044289|NCT00251290|Procedure|auto-titrating continuous positive airway pressure|Continuous positive Airway pressure (CPAP) use for 90 days post TIA
12044290|NCT00251277|Drug|Rituximab|Rituximab will be administered immediately after pheresis to minimize the amount of Rituximab that is removed by the subsequent days pheresis. The guidelines will be that 12 hours must elapse between the end of the first infusion of study drug and the next pheresis. Subsequent infusions would be weekly (plus or minus 2 days) with an attempt made to give study drug infusions after a pheresis that might be the last in a series, i.e. when no pheresis would be scheduled for at least the next day.
12044291|NCT00251264|Procedure|Open stabilization|"Following examination under anesthesia, a 5cm standard deltopectoral incision is made. Dissection is continued exploiting the deltopectoral internervous plane. The conjoined tendon is retracted medially. The underlying subscapularis tendon is identified and incised horizontally or split vertically in its midsubstance. If required for adequate exposure, the subscapularis split may be extended by incising the inferior component of the subscapularis tendon near its insertion on the lesser tuberosity. The shoulder is entered by performing a T shaped arthrotomy with retractors for full exposure of the glenoid. Shoulder pathology is addressed with suture anchor repair of any capsulolabral detachment (ie.Bankart lesion) and/ or a capsular plication for repair of capsular redundancy."
12044292|NCT00251264|Procedure|Arthroscopic stabilization|With the examination under anesthesia completed, the arthroscope is introduced through a standard posterior arthroscopy portal. A diagnostic arthroscopy is performed and the intraarticular pathology identified and documented. Any labral detachment (i.e. Bankart lesion) is repaired using suture anchor fixation and arthroscopic tying techniques. Capsular redundancy is addressed with the use of thermal electrocapsulorrhaphy or arthroscopic suture repair of the redundant capsule. With the repair complete, 40 cc of 0.5% Bupivicaine is introduced into the joint. A sterile dressing is applied over the wounds and the operated shoulder placed in a shoulder immobilizer.
12044293|NCT00251251|Device|Optimal Medical Therapy plus ICD|ICD vs CRT/ICD
12044294|NCT00251251|Device|Optimal Medical Therapy plus CRT/ICD|ICD vs CRT/ICD
12044295|NCT00251238|Drug|Ginkgo biloba extract EGb 761|daily Ginkgo biloba extract EGb 761
12044296|NCT00251225|Drug|Gleevec|Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m^2 administered IV
12044297|NCT00251225|Drug|Docetaxel|60 mg/m^2 administered IV on day 0
12044298|NCT00251212|Behavioral|Adapted Motivational Interviewing & Skills Training|Single session, 45 minute brief intervention during Emergency Department Visit
12044299|NCT00251199|Drug|VX-950|
12044300|NCT00251199|Drug|peginterferon|
12044301|NCT00251186|Drug|Capecitabine and Cetuximab|
12044302|NCT00251173|Behavioral|Strengths Based Case Management (SBCM)|
12044303|NCT00251173|Behavioral|Motivational Enhancement Therapy (MET)|
12044304|NCT00251173|Behavioral|Brief Informational Feedback (BIF) session|
12044305|NCT00251160|Procedure|Electrothermal arthroscopic capsulorrhaphy (ETAC)|The Oratec Vulcan Generator electro-thermal system (Oratec Interventions Inc., Menlo Park, CA, USA) delivers heat at 75C and 40 watts. An anterior portal is established above the superior border of the subscapularis tendon. For MDI patients, the heat probe is introduced through the posterior portal. The capsule is shrunk using a grid pattern until excess volume is diminished. The extent of the heat probe application is identical to the landmarks used for the open ICS. Care is taken to avoid applying heat to the capsule in the region from 5-7 o'clock within 1cm of the glenoid rim to avoid the axillary nerve. The method of heat application utilizes a grid pattern, which is less likely to cause dissolution of the capsule and subsequent catastrophic capsular loss.
12044306|NCT00251160|Procedure|Open inferior capsular shift (ICS)|MDI: lateral capsule released antero-superiorly from rotator interval to equator, posteriorly on the humeral neck. MDL-AII: release from the rotator interval to 7 o'clock (Right) or 5 o'clock (Left) position on humeral neck, to tighten the 2 bands of the inferior GH ligaments, middle GH ligament and rotator interval. Bone adjacent to the articular surface on the surgical neck of the humerus is roughened to create a bleeding bony bed. With the arm in 0deg flexion, 30deg abduction, 30deg external rotation, the inferior leaflet of the capsule is shifted superiorly and slightly laterally, and sutured to the rim of the capsule using a non-absorbable suture. Superior leaflet is shifted inferiorly and sutured. Subscapularis is repaired at its anatomic length using interrupted sutures.
12044307|NCT00251147|Procedure|Open acromioplasty with rotator cuff repair|A standard vertical incision was made over the anterolateral aspect of the acromion. The deltoid muscle was split and stripped off the anterior aspect of the acromion. The anterior and inferior aspect of the acromion was removed. The coracoacromial ligament was excised. Repair of the tear in the cuff tendon(s) was accomplished by suturing leading edge of the tear into the greater tuberosity of the humerus at or near the original site of insertion of the cuff to bone. Trans-osseous sutures, suture anchors and tendon to tendon suture repair techniques were employed for a secure repair with the arm at the side. The surgeon was allowed to use whatever method(s) to create a secure repair. The deltoid was securely reattached to the acromion with the deltoid fascia repaired down the split.
12044308|NCT00251147|Procedure|Arthroscopic acromioplasty with mini-open repair|A standard arthroscopic gleno-humeral arthroscopy was performed followed by an arthroscopic acromioplasty. Three standard arthroscopic portals were used. The lateral portal was centered in line with the cuff tear, and incorporated into the mini-open incision. Initially, a partial bursectomy was performed to improve visualization. The inferior surface of the anterior acromion and the coracoacromial ligament were removed. Following the arthroscopic acromioplasty, a 3-4cm lateral incision was performed in the area of the lateral portal. The deltoid muscle was split longitudinally to expose the tear in the rotator cuff. The tear was repaired in a similar manner to the open repair with tendon to tendon sutures, trans-osseous sutures and with suture anchors.
12044309|NCT00251134|Drug|Zodin (drug)|1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months
12044310|NCT00251134|Drug|Olive oil (placebo)|1 gram olive oil daily for a period of 12 months
12044311|NCT00251121|Other|Mini-invasive electrophysiological study|Transvenous pacing in right heart atrium
12044312|NCT00251121|Other|Atrial pacing|Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
12044313|NCT00251108|Procedure|Cardiorespiratory fitness training|
12044314|NCT00251095|Drug|Taxol|
12044315|NCT00251095|Drug|TOCOSOL Paclitaxel|100 mg/m2/week
12044316|NCT00251082|Drug|continuous combined estradiol and dydrogesterone|0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
12044317|NCT00251082|Drug|continuous combined estradiol and dydrogesterone|1 Mg Estradiol and 5 Mg Dydrogesterone
12044318|NCT00251082|Drug|Placebo|Placebo
12044319|NCT00251069|Drug|Glucosamine sulphate|
12044320|NCT00251056|Drug|mannitol|120mg BD
12044321|NCT00251056|Drug|mannitol|40 mg BD
12044322|NCT00251056|Drug|mannitol|240mg BD
12044323|NCT00251056|Drug|mannitol|400mg BD
12044368|NCT00250679|Drug|Placebo|Placebo nebule or placebo aerolizer
12044424|NCT00250081|Procedure|Regularly ongoing therapy|
12044324|NCT00251043|Behavioral|Interpersonal psychotherapy for depression in pregnancy|IPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth.
12044325|NCT00251043|Behavioral|Parenting education program (PEP)|PEP will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn about the stages of pregnancy, childbirth, and early infant development.
12044326|NCT00251030|Drug|Nelfinavir and Omeprazole|
12044327|NCT00251017|Procedure|Vancomycin|Two hour creatinine clearance before and after vancomycin
12044328|NCT00251017|Procedure|DNA are extracted from the whole blood of subjects|
12044329|NCT00251004|Drug|Everolimus|oral, bis in diem/twice a day (bid)
12044330|NCT00251004|Drug|Mycophenolic Acid (MPA)|2 oral capsules of mycophenolic acid 360mg administered bid
12044331|NCT00251004|Drug|Cyclosporine A (CsA)|CsA dose adjustments were based on CsA trough levels (C0).
12044332|NCT00251004|Drug|Basiliximab|All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.
12044333|NCT00251004|Drug|Corticosteroids|Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.
12044334|NCT00250991|Drug|activase|
12044335|NCT00250991|Drug|integrilin|
12044336|NCT00250978|Drug|bevacizumab with chemotherapy, Pleur-XTM catheter placement|After Pleur-XTM catheter placement patients will receive bevacizumab 15mg/kg IV x 1 dose as a single agent.Three weeks later, chemotherapy will be initiated according to routine clinical practice along with continued use of bevacizumab.
12044337|NCT00250965|Drug|intravenous magnesium|Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily.
12044338|NCT00250952|Drug|Botox Cosmetic™|
12044339|NCT00250939|Biological|Myozyme|20 mg/kg qow
12044340|NCT00250926|Drug|Bortezomib|Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
12044341|NCT00250926|Drug|Dexamethasone|Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
12044342|NCT00250926|Drug|Rituximab|Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles
12044343|NCT00250913|Behavioral|Telephone-based physical activity counseling program|
12044344|NCT00250900|Behavioral|Prescription Fill Status|
12044345|NCT00250887|Drug|Gefitnib|
12044346|NCT00250874|Drug|Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab|
12044347|NCT00250861|Drug|Rituximab|
12044348|NCT00250861|Drug|Aldesleukin|
12044349|NCT00250835|Other|Chemotherapy, Celecoxib, and Radiation|Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment.
12044350|NCT00250822|Drug|Gemcitabine and Oxaliplatin|"Dose:
~Gemcitabine 1000 mg/m2 - IV in about 60 minutes on days 1 & 15. Oxaliplatin 100 mg/m2 - IV over 2hr on days 2 & 16"
12044351|NCT00250809|Procedure|Placement of a central venous catheter|Placement of a central venous catheter
12044352|NCT00250796|Drug|Thalidomide, alpha interferon|If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
12044353|NCT00250796|Drug|Thalidomide, interferon, Octreotide|If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle..
12044354|NCT00250744|Drug|Aprepitant vs. Gabapentin|Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.
12044355|NCT00250744|Drug|Aprepitant vs. Gabapentin|Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.
12044356|NCT00250731|Behavioral|telephone support and behavior change|Diabetes self-management education provided over the telephone either for individuals or couples
12044357|NCT00250731|Other|Diabetes self-management education|Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
12044358|NCT00250718|Drug|Vincristine|Vincristine should be administered intravenously through a freely-running IV.
12044359|NCT00250718|Drug|VP-16|The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
12044360|NCT00250718|Drug|Rituximab|"The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.
~Patients will only receive rituximab if their tumors are CD20 positive CLL or NHL.
~Rituximab will only be administered to patients if they have previously had less than 8 doses. If a patient is treated with rituxan they should have at least 4 doses"
12044361|NCT00250718|Drug|Dexamethasone|Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
12044362|NCT00250718|Drug|Levofloxacin|Levofloxacin will be administered at 500 mg PO qd.
12044363|NCT00250705|Drug|Aripiprazole|The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.
12044364|NCT00250692|Drug|Nitrous Oxide|
12044365|NCT00250679|Drug|Arformoterol tartrate inhalation solution|Arformoterol 15 ųg BID by nebulization
12044366|NCT00250679|Drug|Arformoterol 25 ųg BID|Arformoterol 25 ųg BID by nebulization
12044367|NCT00250679|Drug|Formoterol 12 ųg BID|Formoterol fumarate 12 ųg BID via aerolizer/DPI
12044369|NCT00250666|Procedure|PCT measurement|Peripheral blood samples were collected in the morning, using vacuum tubes (BD Vacutainer SST II Plus plastic tubes; Becton Dickinson Diagnostic Systems, Allschwil, Switzerland). Circulating plasma PCT levels were measured with a time-resolved amplified cryptate emission technology assay (Kryptor PCT; Brahms AG, Hennigsdorf, Germany), with an assay sensitivity of 0.06 mg/L, approximately fourfold above mean normal levels. Measurements were performed 7 days a week.
12044370|NCT00250653|Drug|Saredutant succinate (SR48968C)|
12044371|NCT00250640|Drug|Iloprost (Ventavis, BAYQ6256)|The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet
12044372|NCT00250627|Drug|Saredutant succinate (SR48968C)|
12044373|NCT00250614|Drug|Saredutant succinate (SR48968C)|
12044374|NCT00250601|Drug|Saredutant succinate (SR48968C)|
12044375|NCT00250588|Behavioral|Problem solving skills training|See description in Results
12044376|NCT00250588|Behavioral|Asthma care coordination|See description in Results
12044377|NCT00250588|Other|Usual Care|Usual clinical care
12044378|NCT00250575|Drug|Clozapine|
12044379|NCT00250562|Drug|valsartan plus hydrochlorothiazide|
12044380|NCT00250549|Behavioral|Post test video|We compared the educational effectiveness of a 15-minute posttest counseling video with the normal practice of a session with an HIV counselor.Patients in the experimental group watched an HIV posttest educational video.
12044381|NCT00250536|Drug|nandrolone decanoate|
12044382|NCT00250536|Behavioral|resistance exercise training|
12044383|NCT00250510|Behavioral|Simulated insurance reimbursement|Participants were told they would have the possibility of being reimbursed 50% ($150) of their initial fee ($300) if they: 1) paid the fee in advance or committed 3 monthly payments in advance, 2) attended 10 of 12 class sessions, and 3) lost at least 6% of their current body weight during the program.
12044384|NCT00250497|Behavioral|New Moves|The New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach.
12044385|NCT00250484|Device|Transcranial Magnetic Stimulation|1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day
12044386|NCT00250484|Device|Sham Transcranial Magnetic Stimulation|Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day
12044387|NCT00250471|Procedure|Percutaneous Coronary Intervention (PCI)|
12044388|NCT00250458|Drug|Comparator: Rizatriptan|One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
12044389|NCT00250458|Drug|Comparator: Placebo|One dose matching placebo to Rizatriptan to treat one migraine attack.
12044390|NCT00250445|Drug|MK0663, etoricoxib|
12044391|NCT00250445|Drug|Comparator: Diclofenac sodium|
12044392|NCT00250432|Drug|caspofungin acetate|Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. Duration of Treatment - 14-90 days.
12044393|NCT00250419|Biological|V930|
12044394|NCT00250406|Device|Ureteral Stent|triclosan-eluting ureteral stent
12044395|NCT00250406|Device|Ureteral Stent|Percuflex Plus Stent as the control
12044396|NCT00250393|Drug|Istradefylline (KW-6002)|
12044397|NCT00250367|Drug|risperidone|
12044398|NCT00250354|Drug|Risperidone oral solution|
12044399|NCT00250341|Drug|QVAR|480 mcg
12044400|NCT00250341|Drug|Advair|250/50 mcg
12044401|NCT00250341|Drug|Servent Diskus|50 mcg
12044402|NCT00250328|Device|LapCAC Laparoscopic Compression Anastomosis Clip|
12044403|NCT00250315|Drug|Dobutamine|
12044404|NCT00250302|Procedure|autologous mesenchymal stem cells implantation|
12044405|NCT00250289|Device|a mucosal sticker with herbal formula|
12044406|NCT00250276|Biological|Cervarix™|GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
12044407|NCT00250263|Drug|(agent for immunotherapy) Staloral|"Immunotherapy agent for sublingual daily use. First week (vial containing the concentration 10 IR/ml) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
~Second week (300 IR/ml) (vial containing the concentration 300 IR/ml) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
~Maintenance phase Day 12 to 364 - 8 pressures daily
~The first year will be followed by a second year open label period (optional)- 8 pressures daily"
12044408|NCT00250263|Drug|Placebo|"Matching placebo for sublingual use. Same schedule used for the intervention ACTIVE group.
~First week (vial containing placebo) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
~Second week (300 IR/ml) (vial containing placebo) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
~Maintenance phase Day 12 to 364 - 8 pressures daily"
12044409|NCT00250250|Drug|ZOMACTON|
12044410|NCT00250237|Drug|Haloperidol|Haloperidol 1mg twice daily during 72hours
12044411|NCT00250237|Drug|placebo|Placebo 1mg twice daily during 72hours
12044412|NCT00250224|Device|Radiotherapy stent|
12044413|NCT00250211|Procedure|Functional MRI imaging and tomotherapy|
12044414|NCT00250198|Drug|STA-5326|
12044415|NCT00250185|Drug|Sodium Nitrate|
12044416|NCT00250185|Drug|Acetylcholine|
12044417|NCT00250172|Drug|[C-11](R)-rolipram|
12044418|NCT00250146|Behavioral|Gluten (behaviour)|
12044419|NCT00250133|Procedure|Blood draws|
12044420|NCT00250120|Drug|L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin|delivery mode: inhalation
12044421|NCT00250094|Drug|Topotecan and VP16|"Course 1A: On day 1 treatment will start with a continuous infusion of TPT at 0.4 mg/m2/day for 21 days. A pump will be used to deliver the TPT. The bag in the pump will be replaced every week for sterility precautions.
~Course 1B: On day 28, if ANC is >1,500 and platelets > 100,000, VP-16 will be administered orally at 50 mg/day for 14 days."
12044422|NCT00250081|Procedure|Upper Extremity Tendon transfer|
12044423|NCT00250081|Procedure|Botulinum Toxin injections in Upper Extremity|
12044425|NCT00250068|Drug|Liposomal 9-Nitrocamptothecin|Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks
12044426|NCT00250055|Procedure|Colposcopy, Spectroscopy, and Biopsy|During the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites.
12044427|NCT00250042|Drug|Gleevec and Arsenic Trioxide|Pts. who fit the inclusion criteria, & were on imatinib, 400 mg/day, will be treated with a month of imatinib at 800 mg/d in divided doses (400mg bid) & then started on arsenic trioxide. Pts. already on imatinib 800 mg/day may be started on arsenic trioxide. Pts. unable to tolerate 800 mg/d should be treated at the max. dose tolerated above 400 mg/d. A total of 16 weeks of arsenic trioxide treatment will be administered (15 weeks of maintenance). Pts. are to continue on imatinib 800 mg/day,(or the max. tolerated dose) while receiving the arsenic trioxide. If a pt. has been taken off the arsenic trioxide, they should be continued on gleevec 800 mg per day (or the maximum tolerated dose) until there is evidence of progression of disease.
12044428|NCT00250029|Drug|Oxaliplatin|"Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2 hour intravenous infusion on day 1 of a three week cycle, prior to the 1st dose of capecitabine. 5-HT3 antagonists with or without dexamethasone premedication are strongly recommended. Oxaliplatin may be infused either through a peripheral vein or a central venous line. The infusion lines must be adequately flushed with 5% dextrose solution (D5W) between oxaliplatin infusion & the administration of any other drug.
~Capecitabine is to be administered orally within 30 mins. after the end of a meal. Tablets should be swallowed with approximately 200 mL water (not fruit juices). The first dose of each cycle will be administered as the evening dose on day 1 & the last dose of each cycle is scheduled the morning of day 15, followed by a 7 day rest period. This provides for a total of 28 single doses per cycle over 15 calendar days."
12044429|NCT00250003|Behavioral|Preventive home visits|
12044430|NCT00249990|Drug|9-NC in aerosol reservoir|Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks (45-47).
12044431|NCT00249977|Drug|Capecitabine in Combination with Cisplatin and Irinotecan|"Cisplatin 50 mg/m2 on day 1 (course 1) or day 11 (subsequent courses) Irinotecan 50 mg/m2 on day 1, 8, and 15 (course 1) or day 11, 18 and 25 (subsequent courses).
~Capecitabine will be administered from day 1 to day 10 PO starting on course 2."
12044432|NCT00249964|Drug|Combination Treatment - Cohort 1|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 75 mg/m2 per day from day 2 to day 6."
12044433|NCT00249964|Drug|Combination Treatment - Cohort 2|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 100 mg/m2 per day from day 2 to day 6."
12044434|NCT00249964|Drug|Combination Treatment - Cohort 3|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 125 mg/m2 per day from day 2 to day 6."
12044435|NCT00249964|Drug|Combination Treatment - Cohort 4|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 150 mg/m2 per day from day 2 to day 6."
12044436|NCT00249951|Drug|Alkaline citrate|Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.
12044437|NCT00249938|Drug|Minute Maid Heart Wise orange juice|
12044438|NCT00249938|Drug|Welchol|
12044439|NCT00249925|Behavioral|Home-Based Intervention|
12044440|NCT00249925|Behavioral|Multi-component home-based intervention|
12044441|NCT00249912|Drug|Lapaquistat acetate and rosuvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
12044442|NCT00249912|Drug|Lapaquistat acetate and rosuvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
12044443|NCT00249912|Drug|Rosuvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
12044444|NCT00249899|Drug|Lapaquistat acetate and stable statin therapy|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable statin therapy for up to 24 weeks.
12044445|NCT00249899|Drug|Stable statin therapy|Lapaquistat acetate placebo-matching, tablets, orally, once daily and stable statin therapy for up to 24 weeks.
12044446|NCT00249886|Drug|Citalopram|
12044447|NCT00249873|Drug|clopidogrel (SR25990C)|oral administration (tablets)
12044448|NCT00249873|Drug|placebo|oral administration (tablets)
12044449|NCT00249860|Drug|Interferon-beta-1a|Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
12044450|NCT00249860|Drug|Placebo|Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24
12044451|NCT00249860|Drug|Ribavirin plus Interferon-beta-1a|Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
12044452|NCT00249847|Drug|Paroxetine controlled-release|2-12.5 mg tablets, orally, every day for 4 weeks
12044453|NCT00249847|Drug|Conjugated equine estrogen|0.625 mg tablet, orally, every day for 4 weeks
12044454|NCT00249834|Drug|Gonal-f|GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.
12044455|NCT00249834|Drug|Recombinant human chorionic gonadotrophin (r-hCG)|When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
12044456|NCT00249821|Drug|Saizen®|Saizen® [somatropin (recombinant deoxyribonucleic acid [rDNA] origin) for injection], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
12044738|NCT00247039|Other|Placebo capsules|placebo capsules
12044457|NCT00249821|Drug|Saizen®|Saizen® [somatropin (rDNA origin) for injection], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
12044458|NCT00249808|Drug|Efalizumab - anti-CD11a recombinant human monoclonal antibody|Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
12044459|NCT00249795|Drug|Irbesartan|oral administration (tablets) once daily
12044460|NCT00249795|Drug|placebo|oral administration (tablets) once daily
12044461|NCT00249782|Drug|Vehicle control, 2x/day|
12044462|NCT00249782|Drug|ACZONE (dapsone) Gel, 5%, 2x/day|
12044463|NCT00249782|Drug|ACZONE (dapsone) Gel, 5%, 1x/day|
12044464|NCT00249782|Drug|MetroGel® (metronidazole gel), 1.0% 1x/day|
12044465|NCT00249782|Drug|ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)|
12044466|NCT00249769|Biological|Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)|Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.
12044467|NCT00249769|Biological|Measles Vaccine (MV)|"The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO).
~SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979."
12044468|NCT00249756|Behavioral|Re-entry Modified Therapeutic Community (Re-entry MTC)|In general, the MTC program model applies three fundamental adjustments - increased flexibility, decreased intensity, and greater individualization. The central TC feature is retained; the MTC, like all TC programs, seeks to develop a subculture where clients learn through self-help and affiliation with the community to foster change in themselves and others. From this base (as elaborated below), further adaptations for the population of offenders with MICA disorders were incorporated to include an emphasis on modifying criminal thinking and behavior; on recognizing and responding to the interrelationship of substance abuse, mental illness, and criminality (triple recovery); and on using strategies for symptom management.
12044469|NCT00249756|Behavioral|Parole Supervision and Case Management|Recognizing the complexity of issues facing offenders returning to the community, and the importance of continuity of care, the CDOC established a system of aftercare substance abuse services for offenders on parole or placed in Community Corrections facilities. The statewide treatment options for the offenders consist of a network of community-based clinics and halfway houses throughout Colorado that provide substance abuse services and mental health services. Parole officers and Community Corrections case managers monitor treatment compliance to support participation in prescribed services.
12044470|NCT00249743|Device|FallSaver (formerly called NOCwatch)|
12044471|NCT00249730|Drug|Sildenafil|
12044472|NCT00249717|Behavioral|Contingency management|Receive rewards (prizes) abstinence and attendance
12044473|NCT00249704|Drug|Vitamin D + Sham Exercise|1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
12044474|NCT00249704|Procedure|Vitamin D Placebo + Exercise|Vitamin D placebo + Exercise
12044475|NCT00249704|Procedure|Vitamin D Placebo + Sham Exercise|Vitamin D placebo + Sham (equivalent to placebo) Exercise
12044476|NCT00249704|Drug|Vitamin D + Exercise|1000 IU per day of Vitamin D + Exercise
12044477|NCT00249691|Drug|Topiramate + Cognitive Behavioral Therapy|Topiramate up to 300 mg per day
12044478|NCT00249691|Drug|Placebo + Cognitive Behavioral Therapy|Placebo twice a day
12044479|NCT00249678|Behavioral|Behavior Therapy|
12044480|NCT00249652|Behavioral|TAP|12-session motivational interviewing-based telephone intervention.
12044481|NCT00249652|Other|TAU|The usual care group will receive the same medical services they would otherwise receive if they were not in this study.
12044482|NCT00249639|Behavioral|Contingency management|Rewards valued $1-$100
12044483|NCT00249626|Behavioral|Contingency management|Rewards (prizes) for abstinence
12044484|NCT00249613|Behavioral|Women-Only|Gender-responsive treatment for women only
12044485|NCT00249600|Behavioral|Contingency management|
12044486|NCT00249587|Drug|Methadone|dosed to effect, every six hours
12044487|NCT00249574|Drug|Buprenorphine/naloxone|Human subjects HIV, HCV
12044488|NCT00249574|Drug|pegInterferon|intervention drug 1. buprenorphine/naloxone. street-recruited heroin users induced on bup/naloxone for period of 3-6 months, after which the second intervention is offered. intervention drug 2: pegInterferon/ribavirin. subjects interested in initiation treatment for HCV are offered pegInterferon, 180ug SQ/wk and ribavirin, 800-1200 mg daily for the standard duration of HCV treatment as dictated by genotype.
12044489|NCT00249561|Behavioral|Recovery by Choice|"The experimental condition, the modified TC, was a 6- to 9-month program located in a separate 72-bed housing unit within the prison. Inmates progressed through four program stages with upper level inmates functioning as peer mentors for newer members. The modified, comprehensive TC treatment program focused on increasing awareness and understanding of female roles and relationships as they relate to addiction and drugs used and abused, and emotional and behavioral coping skills. Program elements addressed issues of substance abuse, relapse prevention, mental health, criminal thinking and behavior, coping with trauma and abuse, and parenting skills. All treatment staff received special training related to working with women exposed to trauma and abuse, making the program trauma informed and trauma sensitive."
12044739|NCT00247026|Drug|curcumin; coenzyme q10|
12044490|NCT00249561|Behavioral|The Intensive Outpatient Program (IOP)|The control condition, known at the prison as the Intensive Outpatient Program (IOP), was designed to address substance abuse and criminality, with a focus on prevention of relapse and recidivism. The IOP substance abuse treatment curriculum, designed for delivery over 15 weeks, consisted of a 90-hour manual-driven course (Strategies for Self-Improvement and Change, Wanburg & Milkman, 1998), which employed a cognitive behavioral format to address underlying issues of substance use/abuse and criminal behavior.
12044491|NCT00249548|Behavioral|Contingency management|
12044492|NCT00249535|Behavioral|Contingency management|Rewards (prizes) for abstinence
12044493|NCT00249522|Behavioral|Contingency management|
12044494|NCT00249509|Drug|Nefazodone|
12044495|NCT00249509|Drug|Bupropion|
12044496|NCT00249496|Behavioral|Contingency management|Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
12044497|NCT00249496|Behavioral|Employment Only|Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
12044498|NCT00249483|Drug|Venlafaxine|Venlafaxiine 300mg/day
12044499|NCT00249483|Drug|Placebo|Placebo
12044500|NCT00249470|Behavioral|Abstinence & Work|Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
12044501|NCT00249470|Behavioral|Work Only|Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
12044502|NCT00249457|Behavioral|Contingency management|Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.
12044503|NCT00249444|Drug|Mirtazapine|Mirtazapine
12044504|NCT00249444|Drug|Placebo|placebo
12044505|NCT00249431|Drug|Sertraline|Patients will be started on 25mg/day of Sertraline, and their dose will be increased to 50 mg/day by week two, and then weekly by 50mg/day based on clinical response and emergence of side effects. The maximum dose will be 200mg/day
12044506|NCT00249431|Behavioral|Relapse Prevention Therapy|Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
12044507|NCT00249418|Behavioral|Contingency management|Rewards (prizes) for abstinence
12044508|NCT00249405|Drug|Citalopram + MI|14-week citalopram treatment + Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.
12044509|NCT00249405|Behavioral|Placebo + MI|placebo + single Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.
12044510|NCT00249379|Drug|Acamprosate|Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
12044511|NCT00249366|Drug|Lorazepam (drug)|Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
12044512|NCT00249366|Drug|Lorazepam|Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
12044513|NCT00249353|Drug|methylphenidate hydrochloride|
12044514|NCT00249340|Behavioral|Weight Watchers|
12044515|NCT00249340|Behavioral|brief behavioral weight loss treatment|
12044516|NCT00249340|Behavioral|brief behavioral + Weight Watchers combined treatment|
12044517|NCT00249327|Behavioral|education|
12044518|NCT00249301|Drug|MLN8054|MLN8054 will be administered orally in multiple divided daily doses for 7 days to 21 consecutive days. A 14-day recovery period will follow each dosing period, regardless of its duration. MLN8054 will be supplied in capsules of 5 mg or 25 mg with dose strength expressed as the milligrams of active drug (free acid). MLN8054 will be given on an empty stomach. Patients will be instructed to take nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose.
12044519|NCT00249288|Drug|Folate|Folic acid taken as 2, 1mg capsule daily for 12 weeks
12044520|NCT00249288|Drug|Placebo|Placebo taken as 2, 1mg capsule daily for 12 weeks
12044521|NCT00249275|Device|spectacles|
12044522|NCT00249262|Drug|Taxoprexin|
12044523|NCT00249249|Drug|Pitavastatin|
12044524|NCT00249249|Drug|Atorvastatin|
12044525|NCT00249236|Drug|Risperidone, oral tablets|
12044526|NCT00249223|Drug|Risperidone Long acting injectable|
12044527|NCT00249210|Drug|levofloxacin|
12044528|NCT00249197|Drug|levofloxacin|
12044529|NCT00249171|Drug|risperidone|
12044530|NCT00249158|Drug|Risperidone|
12044531|NCT00249145|Drug|risperidone|
12044532|NCT00249132|Drug|risperidone|
12044533|NCT00249119|Drug|risperidone|
12044534|NCT00249106|Biological|ADVAX|
12044535|NCT00249093|Drug|oxygen|
12044536|NCT00249054|Device|ASR hip prosthesis|Implantation of resurfacing prosthesis
12044537|NCT00249054|Device|ReCap hip prosthesis|Implantation of resurfacing prosthesis
12044538|NCT00249041|Drug|50 mg Etanercept|50 mg Etanercept liquid injected SC once weekly using prefilled syringes
12044539|NCT00249041|Drug|Enbrel liquid|50 mg Etanercept liquid injected SC once weekly using prefilled syringes
12044540|NCT00249015|Behavioral|Physical exercise|perform exercise program 3 days per week and 5 minutes of warm-up and cool-down exercises before and after the main exercise component
12044541|NCT00249002|Drug|ABI-007|
12044542|NCT00248989|Drug|Dehydroepiandrosterone|3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
12044543|NCT00248989|Drug|Placebos|3.0 ml of placebo cream applied on the skin twice daily.
12044544|NCT00248976|Behavioral|Net-present value of individual health behaviors in years|
12044545|NCT00248963|Drug|Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg|
12044546|NCT00248950|Behavioral|Positive affect induction and /or self affirmation induction|
12044547|NCT00248937|Behavioral|Positive affect and self-affect induction|
12044548|NCT00248924|Behavioral|Social Services|
12044549|NCT00248911|Behavioral|Mindfulness based meditation program|Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.
12044550|NCT00248898|Procedure|Cardiac Surgery|Coronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, aortic aneurysm repair
12044551|NCT00248885|Procedure|Regulating Mean Arterial Pressure during cardiopulmonary bypass|Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began.
12044552|NCT00248872|Behavioral|Intervention Group|During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
12044553|NCT00248846|Behavioral|Intervention Group|During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
12044554|NCT00248833|Biological|25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine|The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.
12044555|NCT00248833|Biological|50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine|The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.
12044556|NCT00248820|Procedure|Contrast-enhanced ultrasound|Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).
12044557|NCT00248807|Drug|1.25 mg enalaprilat IV|an angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF)
12044558|NCT00248807|Other|Head up tilt (HUT)|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow.
12044559|NCT00248794|Behavioral|Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)|CRT is a one on one cognitive skills training and Skill training is a group intervention to develop concrete skills of daily living.
12044560|NCT00248794|Behavioral|Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)|ICBCR is a computerized cognitive skills training program and Skill training is a group intervention to develop concrete skills of daily living.
12044561|NCT00248794|Behavioral|Skills Group (SDG)|Skill training is a group intervention to develop concrete skills of daily living. This is augmented with the opportunity to receive up to 5 hours of individual staff contact.
12044562|NCT00248781|Device|Telecommunications system|
12044563|NCT00248781|Device|attention control|health education
12044564|NCT00248768|Device|Transcranial magnetic Stimulator|a device which produces intense magnetic fields in the brain and activates cerebral neurons
12044565|NCT00248755|Procedure|mucociliary clearance scan|
12044566|NCT00248742|Behavioral|Psychological behavioral intervention|3x3 hours group intervention followed by 6-9 hours individual psychotherapy based on cognitive behavioral methods
12044567|NCT00248729|Drug|Etomidate (20mg) or Midazolam (7mg)|
12044568|NCT00248716|Drug|Ferrous gluconate and iron polysaccharide complex|Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months
12044569|NCT00248703|Drug|Docetaxel|Docetaxel 100 mg/m2 3 qw x 6
12044570|NCT00248690|Device|ICP mean wave amplitude|Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage
12044571|NCT00248677|Behavioral|Behavioral Family-Based Intervention|Behavioral family intervention
12044572|NCT00248677|Behavioral|Behavioral Parent-Based Intervention|Behavioral Parent-Only Intervention
12044573|NCT00248651|Drug|Amitriptyline|25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs.
12044574|NCT00248651|Drug|Escitalopram|10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.
12044575|NCT00248651|Drug|Placebo|Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.
12044576|NCT00248638|Drug|Glutamine dipeptide with 15% Clinisol|Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.
12044577|NCT00248638|Drug|15% Clinisol|Subjects randomized to STD-PN will receive 1.5 g/kg/day of 15% Clinisol. The amount of Clinisol administered each day will be determined by daily PN volume intake data.
12044740|NCT00247013|Behavioral|Breast Cancer Screening Compliance|
12044578|NCT00248625|Drug|N-acetylcysteine|The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge.
12044579|NCT00248625|Drug|Placebo|Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and hepatic encephalopathy (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.
12044580|NCT00248612|Drug|Venlafaxine|Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
12044581|NCT00248612|Behavioral|CBT|CBT is Cognitive Behavioral Therapy. Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
12044582|NCT00248612|Other|Progressive muscle relaxation therapy (PMR)|For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.
12044583|NCT00248612|Other|Placebo medication|For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.
12044584|NCT00248586|Behavioral|Standard CBT (S-CBT)|Standard CBT (S-CBT) is a skills-based training program delivered to patients in 10 weekly, 1-hour sessions.
12044585|NCT00248586|Behavioral|Minimal contact CBT (MC-CBT)|Minimal contact CBT (MC-CBT) covers the same range of procedures featured in S-CBT but relies extensively on self study materials.
12044586|NCT00248560|Drug|docetaxel|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
12044587|NCT00248560|Drug|Gemcitabine|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
12044588|NCT00248547|Drug|aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
12044589|NCT00248547|Drug|dexamethasone|For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.
12044590|NCT00248547|Drug|ondansetron|For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy
12044591|NCT00248547|Drug|placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
12044592|NCT00248534|Biological|rituximab|given IV days 1,8, 15 and 22
12044593|NCT00248534|Drug|methylprednisolone|2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)
12044594|NCT00248534|Drug|temozolomide|Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
12044595|NCT00248521|Drug|alvespimycin hydrochloride|
12044596|NCT00248495|Drug|cisplatin|Given IV
12044597|NCT00248495|Drug|pemetrexed disodium|Given IV
12044598|NCT00248495|Procedure|adjuvant therapy|Metastasis prevention/control
12044599|NCT00248495|Procedure|conventional surgery|Undergoing tissue removal
12044600|NCT00248495|Procedure|neoadjuvant therapy|Tumor Reduction
12044601|NCT00248482|Drug|Cisplatin|Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
12044602|NCT00248482|Drug|Gleevec™|Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
12044603|NCT00248482|Drug|irinotecan|Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
12044604|NCT00248469|Behavioral|In-school Sexual Health Education|
12044605|NCT00248469|Behavioral|Youth-friendly health services|
12044606|NCT00248469|Behavioral|Youth condom promotion & distribution|
12044607|NCT00248469|Behavioral|Community activities related to adolescent sexual health|
12044608|NCT00248456|Drug|Calcipotriol plus betamethasone dipropionate ointment|
12044609|NCT00248443|Procedure|Fiberoptic bronchoscopy and bronchoalveolar lavage|
12044610|NCT00248430|Biological|aldesleukin|
12044611|NCT00248430|Biological|therapeutic allogeneic lymphocytes|
12044612|NCT00248430|Drug|melphalan|
12044613|NCT00248430|Procedure|bone marrow ablation with stem cell support|
12044614|NCT00248430|Procedure|peripheral blood stem cell transplantation|
12044615|NCT00248404|Drug|NB1011|
12044616|NCT00248391|Behavioral|upright feeding|
12044617|NCT00248378|Drug|Smoked Cannabis|
12044618|NCT00248365|Biological|Theralux extracorporeal photochemotherapy|
12044619|NCT00248352|Behavioral|Consultation with Endocrinologist|
12044620|NCT00248352|Behavioral|Counseling from Dietician|
12044621|NCT00248352|Behavioral|Counseling from Diabetes Educator|
12044622|NCT00248339|Drug|Peginterferon-alpha-2b (PEG-Intron)|"PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin ~13.3 mg/kg QD
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, ~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, ~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week."
12045225|NCT00243022|Drug|Boswellia serrata extract|given orally
12044623|NCT00248339|Drug|Ribavirin|"PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin ~13.3 mg/kg QD
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, ~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, ~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week."
12044624|NCT00248339|Drug|Epoetin-alpha (Procrit)|"PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, ~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, ~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week."
12044625|NCT00248313|Drug|Rapamune®|
12044626|NCT00248300|Other|Chlorhexidine|Chlorhexidine, 5 ml swab to the oral cavity within 12 hours of endotracheal tube intubation
12044627|NCT00248287|Drug|Irinotecan + Carboplatin|irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle
12044628|NCT00248287|Drug|irinotecan + Carboplatin + erbitux|irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2
12044629|NCT00248261|Drug|ziprasidone, sertraline|
12044630|NCT00248248|Drug|liposomal doxorubicin|Doxil at 50mg/m2 infused over one hour every 3 or 4 weeks for 3-6 cycles
12044631|NCT00248235|Behavioral|Exercise|
12044632|NCT00248222|Behavioral|Supervised aerobic training|
12044633|NCT00248209|Drug|Wellbutrin XL|Patients randomized to the bupropion treatment group will receive bupropion XL150 mg in the AM for 7 days increasing to 300mg/day (single daily dose). The investigator can increase the dose to 450mg per day at Day 28 if clinically indicated.
12044634|NCT00248196|Device|Reprieve Endovascular Temperature Therapy System|
12044635|NCT00248183|Drug|PRX-00023|
12044636|NCT00248170|Drug|Letrozole|2.5 mg tablets
12044637|NCT00248170|Drug|Anastrozole|1 mg tablets
12044638|NCT00248157|Drug|Octreotide acetate in microspheres|
12044639|NCT00248144|Drug|Famciclovir|
12044640|NCT00248131|Drug|Octreotide acetate in microspheres|
12044641|NCT00248118|Drug|Bupropion|During treatment phase, participants will take 300 mg bupropion or placebo daily.
12044642|NCT00248105|Behavioral|Lifestyle Physical Activity Management|Lifestyle Physical Activity Promotion as given by Physical Activity Advocates. Advocates will meet with participants at baseline and every 3 months throughout the study to promote increase in lifestyle physical activity reached through goal setting and Motivational Interviewing (MI)
12044643|NCT00248092|Drug|NRP104|
12044644|NCT00248079|Device|Coronary Artery Stenting|Initial implant of drug eluting stent (zotarolimus)
12044645|NCT00248066|Drug|RESTEN-MP|
12044646|NCT00248053|Drug|curcumin|curcumin 500 mg by mouth, three times a day for 9 months
12044647|NCT00248040|Drug|Reparixin continuous infusion|The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 mg/kg body weight/hour was to be administered for 12 hours. Placebo was volume/schedule matched saline.
12044648|NCT00248040|Drug|reparixin intermittent infusion|A dose of 2.244 mg/kg body weight was to be administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were to be administered over a total period of 22.5 hours. Placebo was volume/schedule matched saline.
12044649|NCT00248040|Other|placebo infusion|placebo was volume/schedule matched saline
12044650|NCT00248014|Device|Mandibular Advancement Via A Functional Appliance|Functional appliance
12044651|NCT00247988|Drug|Weekly Taxotere with weekly carboplatin|
12044652|NCT00247975|Drug|L-carnitine|Patients will be randomized to L-carnitine therapy or placebo. Patients in the treatment group will receive oral L-carnitine (3 grams daily) for 3 days prior to chemotherapy, 1 gram of intravenous L-carnitine (5 cc over 5 minutes, prior to chemotherapy) on the day of chemotherapy and oral L-carnitine (3 grams daily) for 3 days after chemotherapy.
12044653|NCT00247962|Drug|etanercept|50 mg
12044654|NCT00247962|Drug|sulphasalazine (SSZ)|Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
12044655|NCT00247936|Procedure|Laparoscopic Esophagectomy|Laparoscopic Esophagectomy
12044656|NCT00247923|Procedure|Hysteroscopic resection of endometrial polyps. (TCRP)|
12044657|NCT00247910|Drug|Hydrochlorothiazide|Not recorded in detailed description.
12044658|NCT00247897|Drug|Skin antisepsis|See Detailed Description
12044659|NCT00247832|Behavioral|Self-directed motivation|Post-lobectomy patients are provided with a booklet that outlines expected physical activities (sitting up, walking arm exercises) to aim for each day after surgery. It also provides room for the patients to record what they have accomplished.
12044660|NCT00247832|Behavioral|Personal motivational interviewing|Post-lobectomy patients receive daily visits from a study coordinator aimed to motivate the patient to complete various physical activities each day after surgery. The study coordinator goes through the same booklet that is given to Group 2 and helps patients set goals and record their accomplishments.
12044661|NCT00247819|Procedure|Blood draw|
12044662|NCT00247793|Drug|Oral Impact (preoperative enteral nutritional supplement)|
12044663|NCT00247780|Procedure|Pulmonary vein isolation and cavotricuspid ishtmusblock|
12044664|NCT00247754|Behavioral|Cognitive Behaviour Treatment|
12044665|NCT00247741|Drug|spinal administration of articaine|
12044666|NCT00247741|Drug|spinal administration of lidocaine|
12044667|NCT00247728|Drug|PI-88|Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
12044668|NCT00247715|Drug|algeldrate/magnesium oxide|
12044669|NCT00247715|Drug|ranitidine|
12044670|NCT00247715|Drug|pantoprazole|
12044671|NCT00247702|Drug|warfarin|
12044672|NCT00247676|Drug|Sunitinib (SU011248)|Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
12044673|NCT00247663|Drug|Letrozole|
12044674|NCT00247650|Drug|Zoledronic Acid; Letrozole|
12044675|NCT00247624|Drug|Eszopiclone|Eszopiclone 3 mg every night for 8 weeks
12044676|NCT00247624|Drug|Fluoxetine|Fluoxetine 20 mg every morning for 9 weeks
12044677|NCT00247624|Drug|Placebo|Placebo every night for 8 weeks
12044678|NCT00247611|Behavioral|LifeWindows Intervention Sessions|At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.
12044679|NCT00247611|Other|Control|At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.
12044680|NCT00247585|Drug|Ethanol (Bourbon or Vodka)|
12044681|NCT00247572|Drug|NRP104|
12044682|NCT00247559|Biological|Botulinum toxin type A|
12044683|NCT00247546|Behavioral|Multifactorial prevention|
12044684|NCT00247533|Procedure|Digital subtraction angiography and 24-hour simultaneous recorder of electrocardiograph|
12044685|NCT00247520|Drug|topical nasal rEV131|
12044686|NCT00247507|Drug|acetylcysteine|
12044687|NCT00247494|Drug|mycophenol mofetil (MMF, Cellcept®) 500 mg BID|
12044688|NCT00247481|Drug|Gefitinib|
12044689|NCT00247481|Drug|Docetaxel|
12044690|NCT00247468|Procedure|Strict Glucose Control|
12044691|NCT00247455|Drug|Low fibre breakfast cereal (puffed rice/cornflakes)|
12044692|NCT00247455|Drug|High fibre cereal (All Bran/Bran Flakes)|
12044693|NCT00247442|Behavioral|Decision aid|
12044694|NCT00247416|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
12044695|NCT00247416|Drug|Dexamethasone|16 mg bid for 4 days prior to each chemotherapy start.
12044696|NCT00247416|Drug|Carboplatin|AUC 6.0 intravenously over 30 minutes on day 5.
12044697|NCT00247403|Drug|2-deoxyglucose (2DG)|Addition of 2DG to stereotactic radiosurgery. Dose escalation study.
12044698|NCT00247390|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily for up to 42 weeks.
12044699|NCT00247390|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily for up to 42 weeks.
12044700|NCT00247377|Procedure|Gastric bypass surgery|in order to meet health requirements for patient, gastric bypass surgery was undergone
12044701|NCT00247377|Procedure|Lap-Band|in order to meet health requirements for patient, gastric band surgery was undergone
12044702|NCT00247364|Drug|Levetiracetam (Keppra)|
12044703|NCT00247351|Procedure|Cryoablation|
12044704|NCT00247338|Drug|low calorie, low nitrogen parenteral nutrition for patient with NRS score 3|
12044705|NCT00247325|Drug|Iodixanol(Drug)|
12044706|NCT00247312|Radiation|Pd-103|
12044707|NCT00247299|Device|IPL Quantum Product manufactured by Luminis Ltd.|
12044708|NCT00247286|Behavioral|weighted vaginal cones|
12044709|NCT00247286|Behavioral|Biofeedback|Pelvic floor muscles exercises performed with a biofeedback machine
12044710|NCT00247273|Drug|risedronate|tablet, 5 mg risedronate, once a day for 2 years
12044711|NCT00247273|Drug|risedronate|oral, 150 mg risedronate, once a month for 2 years
12044712|NCT00247260|Device|32P BioSilicon|
12044713|NCT00247247|Drug|Comtess®|
12044714|NCT00247234|Behavioral|Schema Therapy|group based schema therapy
12044715|NCT00247234|Behavioral|standard care|standard psychiatric out-patient care
12044716|NCT00247221|Behavioral|MI/Family Check-up|The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention.
12044717|NCT00247221|Behavioral|MI only|An individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome.
12044718|NCT00247208|Device|Taxus polymer-based paclitaxel-eluting stent|Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
12044719|NCT00247208|Device|Express 2 bare metal stent|Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
12044720|NCT00247195|Behavioral|Culturally Congruent Assessment and Treatment|Referral, engagement, and treatment is done following the cultural formulation model in DSM-IV in which patients' views and expectations about depression treatment are included in the assessment and treatment process.
12044721|NCT00247182|Behavioral|Step 1: Minimal Intervention|All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later. All students will complete 3, 6, and 9 month follow-up assessments
12044722|NCT00247182|Behavioral|Step 2: Brief Motivational Intervention|Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.
12044723|NCT00247182|Behavioral|Alcohol Assessment|Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.
12044724|NCT00247169|Drug|progesterone|Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
12044725|NCT00247156|Procedure|Acupressure treatments and NAET treatments|
12044726|NCT00247143|Drug|Kaletra (drug)|
12044727|NCT00247130|Drug|Omeprazole|
12044728|NCT00247130|Drug|Ranitidine|
12044729|NCT00247117|Drug|Metformin|
12044730|NCT00247104|Drug|Cranberries - Vaccinium macrocarpon|
12044731|NCT00247091|Biological|standard-titer measles vaccine|
12044732|NCT00247078|Biological|widow spider antivenom|3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans
12044733|NCT00247078|Biological|Placebo|
12044734|NCT00247052|Drug|diclofenac|diclofenac 50 mg bid versus placebo bid
12044735|NCT00247052|Drug|diclofenac|diclofenac 100 mg per day for 14 days
12044736|NCT00247052|Drug|matching placebo|
12044737|NCT00247039|Dietary Supplement|Solgar Israel|Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
12044741|NCT00247000|Device|Routine Care in a HF clinic vs Home Telehealth Care for HF|
12044742|NCT00246987|Drug|Muraglitazar|
12044743|NCT00246974|Drug|Gemcitabine|intravenous
12044744|NCT00246974|Drug|Cisplatin|intravenous
12044745|NCT00246974|Drug|Gefitinib|oral
12044746|NCT00246948|Procedure|Active conservative treatment of sciatica|
12044747|NCT00246935|Drug|Roflumilast|
12044748|NCT00246922|Drug|Roflumilast|
12044749|NCT00246909|Drug|Pantoprazole|
12044750|NCT00246896|Behavioral|care management|
12044751|NCT00246883|Procedure|Exercise|
12044752|NCT00246818|Procedure|Tai Chi Chuan|
12044753|NCT00246805|Device|Vitatron pacemaker C20 SSIR or T20 SSIR models|VRS: special function that automatically adapts pacing rate to regularize cardiac cycles
12044754|NCT00246792|Behavioral|Group treatment|
12044755|NCT00246779|Procedure|Modified ultrafiltration|
12044756|NCT00246753|Drug|lapatinib ditosylate|1500 mg, daily until disease progression
12044757|NCT00246740|Drug|Periostat|In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
12044758|NCT00246740|Drug|Placebo Oral Tablet|In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
12044759|NCT00246727|Drug|Selected Vegetable and Herb Mix|The phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect.
12044760|NCT00246714|Drug|repeated injections of endotoxin during 5 days|
12044761|NCT00246701|Drug|Simvastatin|Simvastatin
12044762|NCT00246701|Drug|Simvastatin + Lovaza|Simvastatin + Lovaza (omega-3-acid ethyl esters)
12044763|NCT00246688|Drug|Sagopilone (BAY86-5302 , ZK219477)|10.5 mg lyophilized sagopilone per vial
12044764|NCT00246675|Drug|Frusemide|
12044765|NCT00246662|Drug|Vosaroxin|All patients receive vosaroxin Injection
12044766|NCT00246636|Drug|Antara (fenofibrate) + Lovaza|Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
12044767|NCT00246636|Drug|Antara (fenofibrate)|Antara (fenofibrate) + placebo
12044768|NCT00246623|Drug|Exubera (inhaled insulin)|
12044769|NCT00246623|Procedure|8-point glucose diary (to assess pre- and post prandial glucoses)|
12044770|NCT00246623|Procedure|Meal Tolerance Test|
12044771|NCT00246623|Procedure|24-hour continuous glucose monitoring (at select sites)|
12044772|NCT00246623|Procedure|Pulmonary Function Testing|
12044773|NCT00246623|Procedure|Hypoglycemic Event Monitoring|
12044774|NCT00246623|Procedure|Laboratory Assessments|
12044775|NCT00246623|Behavioral|Nutritional Counseling and Diabetes Education|
12044776|NCT00246610|Drug|Nelfinavir mesylate, 625 mg|Nelfinavir 625 mg [dosed orally as 1250 mg BID (two 625 mg tablets given orally BID)] plus Combivir (lamivudine 150 mg plus zidovudine 300 mg BID dosed orally) administered with food. Subjects will start treatment at their baseline visit. Subjects will be treated for up to 26 weeks during pregnancy plus 6 weeks postpartum.
12044777|NCT00246597|Drug|epoetin alfa|
12044778|NCT00246584|Drug|SPP100|
12044779|NCT00246571|Drug|SU011248|SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
12044780|NCT00246571|Drug|Chemotherapy|"The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.
~Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
~Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
~Docetaxel - 75-100 mg/m2 every 3 weeks
~Paclitaxel - 175-200 mg/m2 every 3 weeks
~Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
~Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248."
12044781|NCT00246545|Behavioral|exercise|
12044782|NCT00246532|Drug|Morphine|Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.
12044783|NCT00246532|Drug|Placebo|Patients will receive placebo tablets.
12044784|NCT00246519|Drug|Hydrochlorothiazide|atenolol 50 or 100 mg hydrochlorothiazide 12.5 or 25 mg
12044785|NCT00246519|Drug|Atenolol|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
12044786|NCT00246506|Procedure|intrauterine insemination|An assisted reproduction technique which deposits washed sperm directly into the uterus, bypassing the cervix, and allowing the sperm to enter the fallopian tubes where fertilization normally occurs.
12044787|NCT00246506|Procedure|in vitro fertilization|This procedure involves stimulating the ovaries, retrieving released eggs, fertilizing the eggs, growing the embryos in a laboratory, and then implanting the embryos in the woman's uterus to develop naturally.
12044788|NCT00246467|Biological|Alhydrogel|
12044789|NCT00246467|Biological|rF1 and rV protein antigens|
12044790|NCT00246441|Drug|Paroxetine|16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day
12045226|NCT00243022|Dietary Supplement|cyanocobalamin|given orally
12044791|NCT00246441|Drug|Placebo|treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
12044792|NCT00246428|Behavioral|Motivational Interviewing|Experimental manipulations will be evaluated 6, 9, and 12 months
12044793|NCT00246415|Drug|Memantine|
12044794|NCT00246402|Drug|Acipimox|
12044795|NCT00246389|Drug|cyclobenzaprine hydrochloride|
12044796|NCT00246376|Behavioral|Diet|ATP-III diet
12044797|NCT00246376|Behavioral|Exercise|Supervised exercise in study gym
12044798|NCT00246376|Drug|Niacin|Niaspan, titrated up to 2 grams per day
12044799|NCT00246376|Drug|Fenofibrate|Tricor, 120 mg per day
12044800|NCT00246376|Other|Placebos|Placebos for Niaspan and Tricor
12044801|NCT00246363|Drug|Silymarin|Silymarin (milk thistle)
12044802|NCT00246363|Drug|Placebo|Placebo
12044803|NCT00246350|Procedure|massage|8 light massage treatments and hot pack
12044804|NCT00246350|Procedure|massage|16 light massage treatments and hot packs
12044805|NCT00246350|Procedure|spinal manipulation|8 high velocity, low amplitude spinal manipulation treatments and hot pack
12044806|NCT00246350|Procedure|Spinal manipulation|16 high velocity, low amplitude spinal manipulation treatments and hot pack
12044807|NCT00246337|Drug|Comparator: Placebo|Placebo to match assigned treatment arm; one orally-administered dose
12044808|NCT00246337|Drug|MK0974|MK0974 25 mg; one orally-administered dose
12044809|NCT00246337|Drug|MK0974|MK0974 50 mg; one orally-administered dose
12044810|NCT00246337|Drug|MK0974|MK0974 100 mg; one orally-administered dose
12044811|NCT00246337|Drug|MK0974|MK0974 200 mg; one orally-administered dose
12044812|NCT00246337|Drug|MK0974|MK0974 300 mg; one orally-administered dose
12044813|NCT00246337|Drug|MK0974|MK0974 400 mg; one orally-administered dose
12044814|NCT00246337|Drug|MK0974|MK0974 600 mg; one orally-administered dose
12044815|NCT00246337|Drug|Rizatriptan|Rizatriptan 10 mg; one orally-administered dose
12044816|NCT00246324|Drug|Interferon beta 1a, oral doxycycline|Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.
12044817|NCT00246298|Drug|epoetin alfa|
12044818|NCT00246285|Drug|risperidone|
12044819|NCT00246272|Drug|risperidone|
12044820|NCT00246259|Drug|Risperidone long-acting injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion.
12044821|NCT00246259|Drug|Oral Antipsychotic|Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.
12044822|NCT00246246|Drug|risperidone|
12044823|NCT00246233|Drug|methylphenidate|
12044824|NCT00246220|Drug|methylphenidate hydrochloride|
12044825|NCT00246207|Drug|CONCERTA (OROS methylphenidate hydrochloride)|
12044826|NCT00246194|Drug|risperidone (RISPERDAL CONSTA)|Long-acting injectable of risperidone given as per the prescription from the prescribing physician.
12044827|NCT00246181|Procedure|radiation therapy|Patients will receive 3 fractions
12044828|NCT00246168|Drug|tramadol hydrochloride + acetaminophen|
12044829|NCT00246155|Biological|Botulinum toxin type A|
12044830|NCT00246142|Biological|Botulinum toxin type A|
12044831|NCT00246129|Drug|Alemtuzumab|Monoclonal antibody induction therapy
12044832|NCT00246129|Drug|Daclizumab|Monoclonal antibody induction therapy
12044833|NCT00246116|Procedure|Functional Imaging of Treatment Effects|PET & VQ Scans
12044834|NCT00246103|Drug|Valproic acid|Beginning Dose, Level 1: 15 mg/kg/day.
12044835|NCT00246103|Drug|Epirubicin|Beginning Dose, Level 1: 75 mg/m^2.
12044836|NCT00246103|Drug|5-fluorouracil|For breast cancer participants treated at MTD of Valproic acid and Epirubicin: 5-fluorouracil 500 mg/m^2.
12044837|NCT00246103|Drug|Cyclophosphamide.|For breast cancer participants treated at MTD of Valproic acid and Epirubicin: cyclophosphamide 500 mg/m^2.
12044838|NCT00246090|Drug|E7389|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
12044839|NCT00246064|Drug|infliximab|
12044840|NCT00246051|Behavioral|Sleep Hygiene Education|An education program, consisting of materials from experts in the field of fatigue management, will be provided to all police officers in the intervention group. Videotapes, slides, handouts and other educational material will be compiled to create a variety of information sources for police officers. Examples of materials to be incorporated into this training program would be the Operation Healthy Sleep Training Video, powerpoint created by the Harvard Work Hours, Health and Safety Group and pamphlets provided by the American Academy of Sleep Medicine.
12044841|NCT00246051|Other|Expert-Led Sleep Disorders Screening and Treatment|"Expert-led sleep disorder screening and treatment will consist of visiting police stations and presenting an information session about Operation Healthy Sleep. The session will take place during work time. During the session, we will invite officers to take the Operation Healthy Sleep survey. All subjects that answer the survey indicating that they are at high risk on the Berlin Questionnaire will be contacted to arrange an initial appointment at our OSA research clinic. If they don't meet the criteria they will be disempanelled.
~Positive on the Berlin Questionnaire
~Clinic visit, exam with a physician, given a home diagnostic device (HDD)
~High risk on HDD, seen by physician, given a CPAP machine
~Follow up visit after 2-3 weeks, CPAP data downloaded and reviewed
~Contacted by a sleep health clinic at 3, 6, 12 months
~After 12 months subject will be referred to their primary care physician"
12044842|NCT00246051|Other|Online Sleep Disorders Screening|Online sleep disorder screening will be available to all police officers nation-wide through the Operation Healthy Sleep survey. All subjects that answer the survey questions indicating that they are at high risk of a sleep disorder will be notified either online following the completion of the survey or by email or a letter. Treatment and follow up will not be conducted for individuals who screen positive on the online version of the Operation Healthy Sleep survey.
12044843|NCT00246038|Device|Boston Scientific ENOVUS AAA Endograft|
12044844|NCT00246025|Drug|Dabigatran etexilate|Dabigatran etexilate 110 mg capsule, once a day, oral administration
12044845|NCT00246025|Drug|Dabigatran etexilate|Dabigatran etexilate 150 mg capsule, once a day, oral administration
12044846|NCT00246025|Drug|Dabigatran Etexilate|Dabigatran etexilate 220 mg capsule, once a day, oral administration
12044847|NCT00246025|Drug|placebo|matching placebo capsule, once a day, oral administration
12044848|NCT00246012|Drug|Intetumumab|Intetumumab will be administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). In Phase 2, intetumumab (5 mg/kg or 10 mg/kg) will be administered for 8 cycles until no evidence of disease progression or unacceptable toxicity. If a participant responds to therapy with stable disease (SD) or better, the participant will be eligible to receive up to 8 cycles of extended administrations.
12044849|NCT00246012|Drug|Dacarbazine|Commercially available dacarbazine will be administered intravenously over a 60-minute period (+30 minutes/-30 minutes) and prior to the intetumumab/placebo infusion. In case participants are unable to tolerate dacarbazine even after 2 dose reductions, they will be given the option to continue on intetumumab alone.
12044850|NCT00246012|Drug|Placebo|Placebo will be administered intravenously over a period of 2 hours (+15 minutes/-15 minutes).
12044851|NCT00245986|Procedure|Blood draw|
12044852|NCT00245973|Drug|Bifeprunox|
12044853|NCT00245960|Drug|etanercept|Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.
12044854|NCT00245947|Drug|ERB-041|
12044855|NCT00245934|Drug|Enbrel|
12044856|NCT00245921|Drug|Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg|
12044857|NCT00245908|Drug|azithromycin|
12044858|NCT00245895|Drug|Aranesp|Aranesp
12044859|NCT00245882|Behavioral|Care Coordination|Care coordination with monthly follow-up by a diabetes nurse educator
12044860|NCT00245882|Behavioral|Home Telemedicine|Active care management by a nurse practitioner using home telemedicine
12044861|NCT00245869|Procedure|Contrast-enhanced Ultrasound|
12044862|NCT00245856|Drug|Dalteparin sodium injection|200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.
12044863|NCT00245856|Drug|Warfarin|Titrated to INR 2-3 through study month 3
12044864|NCT00245843|Behavioral|Mother Infant Transaction Program (MITP)|Psychosocial intervention. 11-session one hour standardized intervention program. The aim of the MITP is to help parents to appreciate their infant's unique characteristics,temperament and developmental potential.
12044865|NCT00245830|Procedure|Ischemic Preconditioning|Experimental: Hepatic Ischemic Preconditioning blood flow to the liver will be cut off by hilar clamping for ten minutes followed by release of the clamp prior to removal of the liver from the donor.
12044866|NCT00245817|Behavioral|HINCAB|Psycho-educative intervention performed 2 and 4 weeks after surgery
12044867|NCT00245791|Drug|Levofloxacin|
12044868|NCT00245765|Drug|Certolizumab Pegol|"Pharmaceutical Form: solution for injection in pre-filled syringe
~Route of Administration: subcutaneous use"
12044869|NCT00245765|Other|Placebo|Matching Placebo to Certolizumab Pegol
12044870|NCT00245752|Device|acupuncture|acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
12044871|NCT00245739|Drug|TMC-114|600/100 mg tablets of TMC114/rtv BID until commercial available to the subject
12044872|NCT00245726|Device|FES Cycle|Subjects will use electrical stimulation of the leg muscles to pedal a cycle for 1 hour / 3x week
12044873|NCT00245726|Device|ES therapy|Subjects will electrically stimulate the leg muscles for 1 hour/ 3x week
12044874|NCT00245726|Device|Passive (Motor Assist) Cycle|Subjects will use a cycle that moves the legs for 1 hour/3x per week
12044875|NCT00245713|Drug|levetiracetam|
12044876|NCT00245687|Device|Tiger Tube|
12044877|NCT00245674|Drug|amisulpride|
12044878|NCT00245661|Drug|Temazepam|
12044879|NCT00245648|Drug|fibrinolytic therapy or combination reduced fibrinolytic therapy|
12044880|NCT00245635|Drug|Fluoxetine|Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
12044881|NCT00245635|Drug|Placebo|Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.
12044882|NCT00245622|Biological|Tovaxin Autologous T cell vaccine|subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
12044883|NCT00245622|Biological|Placebo|subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
12044884|NCT00245609|Drug|Pregabalin|
12044885|NCT00245609|Drug|Alprazolam|
12044886|NCT00245609|Drug|Placebo|
12044887|NCT00245596|Drug|sildenafil|
12044888|NCT00245583|Drug|Topiramate|minimum does of 50mg/day
12044889|NCT00245583|Drug|Placebo|matching tablet
12044890|NCT00245570|Drug|Comparator: Montelukast|1 dose montelukast 10 mg tablet given orally in one of three treatment periods
12044891|NCT00245570|Drug|Comparator: Salmeterol|1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
12044892|NCT00245570|Drug|Comparator: Placebo (montelukast)|1 dose matching-image placebo to montelukast tablet in two of three treatment periods
12044893|NCT00245570|Drug|Comparator: Placebo (salmeterol)|1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
12044894|NCT00245557|Drug|Sertraline|"Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day.
~Duration of treatment was 12 weeks."
12044895|NCT00245544|Drug|MK0759|
12044896|NCT00245518|Drug|Isoflavone|
12044897|NCT00245518|Drug|Placebos|
12044898|NCT00245505|Drug|Mesalazine (Mesalamine)|Pentasa (mesalazine) sachets 2 g morning + 2 g evening during 12 weeks treatment
12044899|NCT00245492|Procedure|Chromocolonoscopy|Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.
12044900|NCT00245479|Drug|Primary nocturnal enuresis|Desmopressin
12044901|NCT00245466|Drug|Degarelix|Given as a subcutaneous injection once every 4 weeks.
12044902|NCT00245466|Drug|Degarelix|Given as a subcutaneous injection once every 4 weeks.
12044903|NCT00245466|Drug|Degarelix|Given as a subcutaneous injection once every 4 weeks.
12045227|NCT00243009|Drug|cyclosporine|
12044904|NCT00245453|Drug|azithromycin|250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5
12044905|NCT00245453|Drug|telithromycin|400 mg tablets; 2 tablets once daily (QD) for 5 days
12044906|NCT00245453|Drug|Clarythromycin|500 mg extended release tablets; 2 tablets QD for 7 days
12044907|NCT00245440|Drug|Azithromycin|250 mg tablets; 2 tablets once daily (500 mg) for 3 days
12044908|NCT00245440|Drug|Telithromycin|400 mg tablets; 2 tablets once daily (800 mg) for 5 days
12044909|NCT00245427|Drug|all macrolide antibiotics|Varies based on antibiotic
12044910|NCT00245427|Drug|all beta-lactam antibiotics|Varies based on antibiotic
12044911|NCT00245414|Drug|Pegasys®|180μg for s.c./week for 48 weeks
12044912|NCT00245414|Drug|Pegasys®|180μg for s.c./week for 24 weeks
12044913|NCT00245401|Device|CYPHERTM Sirolimus-Eluting Coronary Stent|
12044914|NCT00245388|Drug|Muraglitazar|
12044915|NCT00245375|Drug|Tylenol #3|
12044916|NCT00245375|Drug|Combination Tylenol and Ibuprofen|
12044917|NCT00245362|Biological|CG 8020 and CG 2505|
12044918|NCT00245349|Procedure|F-18 Fluorothymidine|
12044919|NCT00245336|Biological|rThrombin|1000 U/mL applied topically in combination with absorbable gelatin sponge
12044920|NCT00245336|Drug|bovine thrombin|1000 U/mL applied topically in combination with absorbable gelatin sponge
12044921|NCT00245323|Behavioral|Smoking status as a routine vital sign|
12044922|NCT00245310|Procedure|Indocyangreen (ICG) clearance|
12044923|NCT00245297|Drug|Kogenate FS, reconstituted in a suspension of liposomes|
12044924|NCT00245271|Drug|OMS103HP|Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
12044925|NCT00245271|Drug|Vehicle|Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.
12044926|NCT00245258|Drug|Sildenafil Citrate|
12044927|NCT00245245|Drug|recombinant porcine coagulation factor VIII (OBI-1)|
12044928|NCT00245232|Behavioral|Cognitive Therapy|
12044929|NCT00245232|Behavioral|Cognitive Processing Therapy|
12044930|NCT00245232|Behavioral|Written Exposure|
12044931|NCT00245219|Behavioral|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
12044932|NCT00245219|Behavioral|Peer support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
12044933|NCT00245206|Drug|Aripiprazole|Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
12044934|NCT00245206|Drug|Olanzapine|Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.
12044935|NCT00245206|Drug|Risperidone|Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
12044936|NCT00245193|Behavioral|Motivationally-Enhanced Interpersonal Psychotherapy|
12044937|NCT00245180|Behavioral|Diet|
12044938|NCT00245180|Behavioral|Exercise|
12044939|NCT00245167|Procedure|Tracheal Aspirate Fluid|
12044940|NCT00245154|Drug|carboplatin|Given IV
12044941|NCT00245154|Drug|cediranib maleate|Given orally
12044942|NCT00245154|Drug|paclitaxel|Given IV
12044943|NCT00245154|Other|placebo|Given orally
12044944|NCT00245141|Biological|dactinomycin|
12044945|NCT00245141|Drug|cyclophosphamide|
12044946|NCT00245141|Drug|vincristine sulfate|
12044947|NCT00245141|Radiation|radiation therapy|
12044948|NCT00245128|Drug|imatinib mesylate|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
12044949|NCT00245115|Biological|filgrastim|
12044950|NCT00245115|Drug|busulfan|
12044951|NCT00245115|Drug|cyclophosphamide|
12044952|NCT00245115|Procedure|in vitro-treated bone marrow transplantation|
12044953|NCT00245115|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12044954|NCT00245102|Drug|sorafenib tosylate|Given orally
12044955|NCT00245089|Biological|dactinomycin|
12044956|NCT00245089|Drug|cyclophosphamide|
12044957|NCT00245089|Drug|vincristine sulfate|
12044958|NCT00245076|Behavioral|smoking cessation intervention|
12044959|NCT00245076|Other|internet-based intervention|
12044960|NCT00245063|Drug|cediranib maleate|Given PO
12044961|NCT00245063|Other|laboratory biomarker analysis|Correlative studies
12044962|NCT00245063|Other|pharmacogenomic studies|Optional correlative studies
12044963|NCT00245050|Dietary Supplement|pyridoxine hydrochloride|Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine twice 100 mg daily on days 1-28.
12044964|NCT00245050|Drug|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
12044965|NCT00245050|Drug|doxorubicin HCL liposome|IV, 40mg/m2
12044966|NCT00245037|Biological|therapeutic allogeneic lymphocytes|A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
12044967|NCT00245037|Drug|busulfan|"Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
~IV busulfan is available and diluted and administered per package insert guidelines."
12045228|NCT00243009|Drug|fludarabine phosphate|
12044968|NCT00245037|Drug|cyclosporine|"Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including Interleukin 2 (IL-2) and Interleukin 4 (IL-4).
~- Starting on day -3, Cyclosporine (CSP) is given at a dose of 4.0 mg/kg p.o. b.i.d."
12044969|NCT00245037|Drug|fludarabine phosphate|"Fludarabine's active metabolite 2-fluoro-ara-A is an antimetabolite that inhibits DNA primase, DNA polymerase alpha and ribonucleotide nuclease.
~Dosing: Days -4, -3 and -2: Fludarabine 30 mg/m2/day IV. Total dose equals 90 mg/m2.
~Monitoring: Fludarabine level is not monitored.
~Dose Adjustments: There are no provisions for fludarabine dose adjustments."
12044970|NCT00245037|Drug|mycophenolate mofetil|"Mycophenolate mofetil (MMF) is the morpholinyl ethyl ester of mycophenolic acid (MPA) and reversibly inhibits inosine monophosphate dehydrogenase, particularly the type II isoform that is more prominent in activated lymphocytes. As a result of the inhibition of de novo purine synthesis, proliferation of B- and T-lymphocytes is blocked and antibody production is inhibited.
~Related Donors: MMF will be given daily at 15mg/kg q 12 hrs until day +28, then stop without tapering. Doses will be rounded to the nearest 250 mg (capsules are 250 mg).
~Unrelated Donors: MMF will be given daily at 15mg/kg q 8 hrs until day +28, then given daily at 15mg/kg q 12 hours until day +56, then stop without tapering. Doses will be rounded to the nearest 250 mg (capsules are 250 mg)."
12044971|NCT00245037|Procedure|peripheral blood stem cell transplantation|"Bone marrow transplantation (BMT) and peripheral blood stem cell transplantation (PBSCT) are procedures that restore stem cells that have been destroyed by high doses of chemotherapy and/or radiation therapy. There are three types of transplants:
~In autologous transplants, patients receive their own stem cells.
~In syngeneic transplants, patients receive stem cells from their identical twin.
~In allogeneic transplants, patients receive stem cells from their brother, sister, or parent. A person who is not related to the patient (an unrelated donor) also may be used."
12044972|NCT00245037|Radiation|Total Body Irradiation (TBI)|"TBI is a form of radiotherapy used primarily as part of the preparative regimen for haematopoietic stem cell (or bone marrow) transplantation. As the name implies, TBI involves irradiation of the entire body, though in modern practice the lungs are often partially shielded to lower the risk of radiation-induced lung injury.
~Toxicities: At the dosage used, side effects are not expected. Nevertheless, there may be fever, alopecia, parotitis, diarrhea, reversible skin pigmentation, mucositis and late effects including cataract formation, pulmonary damage, carcinogenesis, and sterilization.
~Dosing: TBI will be given in one 200 cGy fraction from linear accelerator at a rate of 15-19 cGy/min."
12044973|NCT00245037|Drug|Granulocyte colony-stimulating factor (G-CSF)|"Granulocyte colony-stimulating factor (G-CSF or GCSF) is a colony-stimulating factor hormone. G-CSF is also known as colony-stimulating factor 3 (CSF 3).
~It is a glycoprotein, growth factor and cytokine produced by a number of different tissues to stimulate the bone marrow to produce granulocytes and stem cells. G-CSF then stimulates the bone marrow to release them into the blood.
~Toxicities: At the dosage used, the most common side effect will be medullary bone pain.
~Dosing: 5 mcg/kg/day given per institutional standards (on approximately days 10-15 or not at all)."
12044974|NCT00245037|Drug|Phenytoin|This drug is used to prevent seizures while on chemotherapy.
12044975|NCT00245037|Drug|Methotrexate|Methotrexate is used to treat severe psoriasis (a skin disease in which red, scaly patches form on some areas of the body) that cannot be controlled by other treatments.
12044976|NCT00245024|Drug|sulindac|
12044977|NCT00245024|Other|laboratory biomarker analysis|
12044978|NCT00245011|Biological|filgrastim|Filgrastim will be administered post post chemotherapy until target WBC (white blood cell) count is achieved.
12044979|NCT00245011|Drug|ifosfamide|Ifosfamide administered IV.
12044980|NCT00245011|Procedure|peripheral blood stem cell transplantation|Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered
12044981|NCT00245011|Radiation|Sm-EDTMP (low dose)|Sm-EDTMP (low dose) administered after autologous stem cell collection
12044982|NCT00245011|Radiation|sm-EDTMP (higher dose)|Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.
12044983|NCT00244998|Drug|fulvestrant|IM
12044984|NCT00244985|Biological|rituximab|IV
12044985|NCT00244985|Drug|pegylated liposomal doxorubicin hydrochloride|IV
12044986|NCT00244972|Other|Laboratory Biomarker Analysis|Correlative studies
12044987|NCT00244972|Drug|Sorafenib Tosylate|Given PO
12044988|NCT00244972|Drug|Tipifarnib|Given PO
12044989|NCT00244959|Drug|anastrozole|1 mg orally daily for 12 months
12044990|NCT00244959|Procedure|adjuvant therapy|treatment received after breast cancer surgery
12044991|NCT00244946|Biological|therapeutic autologous lymphocytes|Lymphocytes collected by standard apheresis technique either prior to or post stem cell mobilization and collection
12044992|NCT00244946|Drug|carmustine|
12044993|NCT00244946|Drug|cytarabine|
12044994|NCT00244946|Drug|etoposide|
12044995|NCT00244946|Drug|melphalan|
12044996|NCT00244946|Procedure|peripheral blood stem cell transplantation (PBSCT)|
12044997|NCT00244933|Dietary Supplement|genistein|Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
12044998|NCT00244933|Drug|gemcitabine|Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
12044999|NCT00244933|Procedure|Tumor biopsy|Biopsy of tumor prior to dose of genistein (Novasoy)
12045000|NCT00244920|Drug|bicalutamide|
12045001|NCT00244920|Drug|leuprolide acetate|
12045002|NCT00244920|Drug|squalamine lactate|
12045003|NCT00244920|Procedure|adjuvant therapy|
12045004|NCT00244920|Procedure|antiandrogen therapy|
12045005|NCT00244920|Procedure|antiangiogenesis therapy|
12045006|NCT00244920|Procedure|conventional surgery|
12045007|NCT00244920|Procedure|neoadjuvant therapy|
12045008|NCT00244920|Procedure|releasing hormone agonist therapy|
12045009|NCT00244907|Dietary Supplement|Genistein vs Risedronate|Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
12045120|NCT00244023|Drug|testosterone|testosterone gel, one sachet of 50 mg applied once a day, possibly titrated to 100 mg if insufficient effect
12045121|NCT00244023|Other|placebo gel|one sachet of placebo gel once a day possibly titrated to 2 sachets if insufficient efficacy
12045010|NCT00244894|Procedure|acupuncture therapy|Acupuncture treatments will be administered by a qualified practitioner twice a week for the first four weeks and once per week for an additional 6 weeks. Sterile, disposable Seirin needles will be placed bilaterally at the point Gallbladder 34, and along the spine at Bladder 15, Bladder 23, and Bladder 32. Low intensity electrostimulation at 2 Hz will be used for both Bladder 23 and Bladder 32. Points will also be placed unilaterally at Governing vessel 20, Heart 7, Pericardium 6, Liver 2, and Spleen 6
12045011|NCT00244894|Procedure|fatigue assessment and management|Patients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper.
12045012|NCT00244894|Procedure|hot flashes attenuation|Patients will be asked to report hot flash frequency and severity daily using the hot flash diary (HFD) and hot flash severity guidelines (HFSG) throughout the treatment period.
12045013|NCT00244894|Procedure|management of therapy complications|Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.
12045014|NCT00244894|Procedure|quality-of-life assessment|Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.
12045015|NCT00244881|Drug|cediranib maleate|Given orally
12045016|NCT00244881|Other|laboratory biomarker analysis|Correlative studies
12045017|NCT00244868|Other|counseling intervention|
12045018|NCT00244868|Other|educational intervention|
12045019|NCT00244855|Other|pharmacological study|Correlative studies
12045020|NCT00244855|Biological|rituximab|Given IV
12045021|NCT00244855|Drug|dexamethasone|Given IV
12045022|NCT00244855|Other|laboratory biomarker analysis|Correlative studies
12045023|NCT00244842|Drug|voclosporin|voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
12045024|NCT00244842|Drug|Placebo|Placebo
12045025|NCT00244829|Drug|imatinib mesylate|
12045026|NCT00244829|Procedure|adjuvant therapy|
12045027|NCT00244816|Drug|Taxoprexin|
12045028|NCT00244790|Behavioral|Diet|crossover low vs high protein diet before and after weight loss
12045029|NCT00244777|Drug|Hypo-osmolar ORS|
12045030|NCT00244764|Drug|GW786034|All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
12045031|NCT00244764|Drug|Placebo|All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
12045032|NCT00244751|Drug|GI262570 0.5 mg|GI262570 0.5 mg
12045033|NCT00244751|Drug|GI262570 1.0 mg|GI262570 1.0 mg
12045034|NCT00244751|Drug|Placebo|Placebo
12045035|NCT00244738|Dietary Supplement|Castor oil|Patients who received castor oil for labor induction
12045036|NCT00244738|Dietary Supplement|Sunflower oil|Patients who received sunflower oil as a placebo
12045037|NCT00244725|Drug|Odiparcil|
12045038|NCT00244725|Drug|Warfarin|
12045039|NCT00244725|Drug|Coumadin|
12045040|NCT00244712|Drug|emtricitabine/tenofovir|The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
12045041|NCT00244712|Drug|abacavir/lamivudine|The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.
12045042|NCT00244699|Behavioral|MI Alone or Plus Mindfulness-Based Skills Training|
12045043|NCT00244686|Drug|Mepolizumab|open label investigational product
12045044|NCT00244673|Biological|DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4|Trial of not providing 3. and/or 4. DTP together with or after MV at 9 to 18 month of age.
12045045|NCT00244660|Procedure|Frequent blood pressure measurements|
12045046|NCT00244660|Behavioral|Education|
12045047|NCT00244647|Drug|RESTEN-MP|
12045048|NCT00244634|Drug|candsartan cilexetil|
12045049|NCT00244621|Drug|candesartan cilexetil (Atacand)|0.05 mg/kg once daily oral liquid dose
12045050|NCT00244621|Drug|candesartan cilexetil (Atacand)|0.20 mg/kg once daily oral liquid dose
12045051|NCT00244621|Drug|candesartan cilexetil (Atacand)|0.40 mg/kg once daily oral liquid dose
12045052|NCT00244608|Drug|Budesonide/Formoterol Turbuhaler|
12045053|NCT00244608|Drug|Budesonide Turbuhaler (Pulmicort)|
12045054|NCT00244608|Drug|Terbutaline Turbuhaler|
12045055|NCT00244595|Drug|candsartan cilexetil|
12045056|NCT00244569|Drug|13C-Methacetin|
12045057|NCT00244569|Device|Breath ID Machine|
12045058|NCT00244556|Drug|Methotrexate plus ENBREL or ENBREL alone|
12045059|NCT00244543|Drug|R89674 (generic name not yet established)|
12045060|NCT00244530|Drug|Nifedipine|
12045061|NCT00244517|Drug|TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl|TTE measurements were performed during remifentanil 2 ng/ml TCI end-organ concentration, 1 MAC of either anesthetic gas under spontaneous ventilation and 1 MAC of either anesthetic under IPPV
12045062|NCT00244517|Drug|Sevoflurane, Isoflurane, Desflurane|1 MAC
12045063|NCT00244504|Drug|moxonidine|moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
12045064|NCT00244491|Behavioral|Care Transitions Intervention|
12045065|NCT00244478|Dietary Supplement|Soy Protein Dietary Supplement|The soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving.
12045066|NCT00244478|Dietary Supplement|Placebo|The control shake will have 20 g casein substituted for soy protein, and will be otherwise identical to the soy shakes. The shakes will be available in two flavors: chocolate and vanilla.
12045067|NCT00244452|Drug|Cetrorelix|
12045068|NCT00244439|Drug|MALG|30 minute application
12045069|NCT00244439|Drug|Ovide (malathion) lotion 0.05%|8-12 hour application
12045070|NCT00244439|Drug|Permethrin 1%|10 minute application
12045071|NCT00244426|Drug|indobufen|Indobufen capsules 100 and 200mg
12045072|NCT00244426|Drug|aspirin|Acetylsalicylic acid capsules 300mg
12045073|NCT00244387|Drug|SPM 962|
12045074|NCT00244374|Biological|Hepatitis A & B vaccine|Each subject will receive a total of 4 immunizations over 6 months on a 0-1-2-6 month schedule. At the initial visit, subjects>18 years of age will receive the Twinrix vaccine and subjects<18 years of age will receive the Engerix-B vaccine. Cohort subjects>18 years found to have HAV antibody at screening will receive Engerix-B for their remaining 3 immunizations. All subjects will receive: an immunization record with the first vaccine dose entered and the dates the next doses are due; helpful hints for remembering vaccine appointments; and written instructions on where and how to get immunized outside of SF.
12045075|NCT00244374|Behavioral|Outreach|Outreach worker vaccine adherence support: Half of cohort subjects will be assigned to outreach worker vaccine adherence support and will meet with their outreach workers from Haight Ashbury Youth Outreach Team (HAYOT) and Glide Health Services on the day of vaccine cohort study enrollment. Intensive vaccination tracking and in-person outreach support will begin one week before the second and third vaccine doses are due, and again two weeks before the fourth dose is due.
12045076|NCT00244374|Behavioral|AIC|The Adult Immunization Clinic (AIC) is a public low-cost vaccine clinic located centrally at 101 Grove Street in the lobby of the San Francisco Department of Public Health (SFDPH). The clinic is open from Monday-Friday 9 a.m. to 4 p.m. Nurses at the AIC will be available 40 hours/week to administer free immunizations to study subjects.
12045077|NCT00244374|Behavioral|SEP|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6. Research nurses will provide 16 hours/week of vaccine administration services at SEPs well attended by young IDU. The San Francisco Needle Exchange (SFNE) serves primarily youth and young adults on Mondays, Wednesdays, and Fridays from 5-7 p.m. in an indoor location in the Haight-Ashbury district. A study nurse will be at SFNE for a total of 6 hours per week. HIV Prevention Project (HPP) sites also operate for 2 hrs each (Tues, Thu, Fri, Sat). Medical services are provided either in a clinic setting at indoor sites (6th Street) or at outdoor sites (Hemlock Alley, Duboce). A study nurse will attend each of these 5 weekly sites for a total of 10 hours/week.
12045078|NCT00244361|Drug|rituximab|
12045079|NCT00244348|Drug|Oxaliplatin (via HAI)|
12045080|NCT00244348|Drug|5 Fluorouracil (systemic)|
12045081|NCT00244322|Drug|LY450139 dihydrate|
12045082|NCT00244322|Drug|placebo|
12045083|NCT00244309|Drug|tamsulosin and/or dutasteride|
12045084|NCT00244296|Drug|Duloxetine hydrochloride|
12045085|NCT00244296|Drug|placebo|
12045086|NCT00244283|Drug|Sevoflurane|
12045087|NCT00244283|Procedure|High thoracic epidural analgesia|
12045088|NCT00244270|Device|totally implantable vascular access device|totally implantable vascular access device
12045089|NCT00244257|Biological|GMA161|0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
12045090|NCT00244257|Biological|GMA161|0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
12045091|NCT00244257|Biological|GMA161|0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
12045092|NCT00244257|Biological|GMA161|1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
12045093|NCT00244257|Biological|GMA161|3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
12045094|NCT00244244|Drug|arimoclomol|
12045095|NCT00244231|Drug|Nidadd|
12045096|NCT00244218|Drug|tetrahydrobiopterin (BH4)|Either placebo or BH4, 10mg/kg/day will be given for three months. Then the patient will be given three additional months of open label BH4 at the same rate.
12045097|NCT00244205|Procedure|Identifying genes methylated in urine|
12045098|NCT00244192|Drug|infliximab (Remicade)|
12045099|NCT00244179|Drug|interferon-gamma|
12045100|NCT00244179|Drug|infliximab|
12045101|NCT00244179|Drug|dmard|
12045102|NCT00244166|Drug|prednisolone|
12045103|NCT00244153|Drug|intraarticular morphine|
12045104|NCT00244153|Drug|intraarticular dexamethasone|
12045105|NCT00244140|Drug|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
12045106|NCT00244140|Drug|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
12045107|NCT00244127|Drug|Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)|
12045108|NCT00244114|Drug|blood draw|Single blood sample collected to perform histamine release assay.
12045109|NCT00244114|Procedure|Blood draw|Single blood sample collected to perform histamine release assay.
12045110|NCT00244101|Drug|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
12045111|NCT00244101|Device|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
12045112|NCT00244101|Drug|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
12045113|NCT00244075|Dietary Supplement|nutritional supplement|either oral nutritional formula (Nepro) or intravenous IDPN solution will be administered during hemodialysis; Nepro has a total calorie amount as well as protein, carbohydrate and fat content that are comparable to that of IDPN, and will be provided at four equal amounts with 1-hour intervals throughout the study (150 ml for a total of 600 ml over 4 hours of hemodialysis); IDPN consists of 225 ml of amino acids at a concentration of 15%, 112.5 ml of dextrose at 50% and 112.5 ml of lipids at 20%, will be given at a rate of 150 ml/hr, and will provide 209 kcal/hr
12045114|NCT00244075|Drug|recombinant human growth hormone (rcGH)|subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days
12045115|NCT00244075|Behavioral|exercise|either dual leg press (3 sets of 8-12 repetitions) beginning 30 minutes prior to hemodialysis, or modified stepper (minimum of 15 minutes up to a maximum of 90 minutes, depending upon the patient's tolerance) beginning 15 minutes post initiation of hemodialysis
12045116|NCT00244062|Behavioral|counseling|
12045117|NCT00244049|Behavioral|counseling|Physicians discussed high-risk/binge drinking with college-aged individuals in a health care setting.
12045118|NCT00244049|Other|Brief Intervention|Physicians discussed effects of high-risk/binge drinking with college-aged individuals in a health care setting.
12045119|NCT00244023|Drug|Testosterone gel|one sachet of 50 mg applied once a day, possibly titrated to two sachets if insufficient improvement of erectile function
12045122|NCT00244010|Device|Allogeneic stem cell transplant|Participants will receive a reduced intensity conditioning regimen consisting of fludarabine, thiotepa, melphalan, and OKT3 followed by an infusion of haploidentical stem cells. Rituximab will be administered within 24 hours of the infusion in an effort to prevent posttransplant lymphoproliferative disorder LPD. In addition to T-cell depletion of the donor product, participant will receive mycophenolate mofetil for prophylaxis of GVHD.
12045123|NCT00243997|Behavioral|Becoming Parents Program|Couple focused educational program for couples adding a new baby to the family-21 hours of workshops during pregnancy with two three hour workshops after the baby is born.
12045124|NCT00243984|Drug|topiramate|
12045125|NCT00243971|Drug|SPM 962|
12045126|NCT00243945|Drug|Rotigotine|
12045127|NCT00243932|Drug|coenzyme Q10|antioxidant and mitochondrial cofactor, given in capsules three times daily
12045128|NCT00243932|Drug|Placebo|Placebo capsules, indistinguishable from CoQ10 capsules, given three times daily
12045129|NCT00243919|Behavioral|Early locomotor training program|The early locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 2 months post-stroke.
12045130|NCT00243919|Behavioral|Late locomotor training program|The late locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 6 months post-stroke.
12045131|NCT00243919|Behavioral|Home Exercise Program|Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
12045132|NCT00243906|Drug|Recombinant tissue plasminogen activator|Low-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg).
12045133|NCT00243906|Procedure|Low-intensity ultrasound|Delivery of additional IA rt-PA (up to 22 mg) in the setting of low-energy ultrasound via the EKOS microinfusion catheter at the site of IA occlusion in acute ischemic stroke patients with large strokes (NIHSS >/= 10) treated within 3 hours of symptoms onset.
12045134|NCT00243893|Drug|minocycline|Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
12045135|NCT00243893|Drug|doxycycline|Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
12045136|NCT00243880|Drug|lovastatin|investigators will treat the patients within 24 hours of symptom onset with short term high-dose lovastatin at escalating dosage. The escalating dosage levels will be 1, 3, 6, 8, and 10 mg/kg per day for 3 days.
12045137|NCT00243867|Drug|Taxoprexin|6. Other events that, based upon appropriate medical judgement, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes
12045138|NCT00243854|Drug|Tarceva|Tarceva: 100mg/day x 2 weeks (Days 1-14) +
12045139|NCT00243841|Radiation|Stereotactic Body Radiation|Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
12045140|NCT00243828|Device|Total Face Mask|
12045141|NCT00243815|Drug|ibuprofen|
12045142|NCT00243789|Drug|Pentoxifylline|"Participants will be randomized to receive either pentoxifylline or placebo in addition to their stable steroid therapy. Active drug and placebo preparations will be supplied as gel capsules of identical size, appearance and taste. Active drug capsules will contain one 400 mg time-release pentoxifylline tablet and inert filler. Placebo capsules will contain inert filler.
~Based on weight at screening, <30 mg will receive 1 400 capsule/day; 30-49 kg will receive two 400 capsules/day; 50 kg or greater will receive three 400 mg capsules/day."
12045143|NCT00243763|Drug|TKI258|
12045144|NCT00243750|Drug|Methotrexate|
12045145|NCT00243737|Drug|Artesunate-Mefloquine|
12045146|NCT00243724|Drug|Esomeprazole|
12045147|NCT00243711|Drug|Carboxymethylcellulose sodium and Glycerin|
12045148|NCT00243698|Drug|SonoVue (sulphur hexafluoride microbubbles)|One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)
12045149|NCT00243685|Other|Laboratory Assay|Chemotherapy
12045150|NCT00243685|Other|Mick Assay|Chemotherapy doctor determined from results
12045151|NCT00243672|Drug|Atorvastatin|
12045152|NCT00243672|Drug|Gemfibrozil|
12045153|NCT00243659|Biological|ReFacto AF|
12045154|NCT00243646|Radiation|External beam radiation|All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant
12045155|NCT00243646|Drug|Lupron|9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
12045156|NCT00243646|Drug|Casodex|9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
12045157|NCT00243633|Procedure|Real-time contrast-enhanced ultrasound sonography|
12045158|NCT00243620|Device|Vacuum therapy (device)|
12045159|NCT00243607|Other|hydrotherapy according to Kneipp rules|2-5 applications of hydrotherapy according to Kneipp rules (self application) per day
12045160|NCT00243594|Biological|Peptide-pulsed dendritic cells|peptide-pulsed dendritic cells
12045161|NCT00243581|Behavioral|Dean Ornish Heart Disease Reversing Program|
12045162|NCT00243568|Drug|Vicriviroc|
12045163|NCT00243555|Procedure|allergy skin testing|
12045164|NCT00243555|Procedure|venepuncture|
12045165|NCT00243542|Drug|ACZONE Gel, 5%|
12045166|NCT00243542|Drug|Vehicle|
12045167|NCT00243529|Biological|autologous dendritic cell vaccine|
12045168|NCT00243516|Device|PREtest Consult|
12045169|NCT00243503|Drug|SU011248/Trastuzumab|SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
12045170|NCT00243490|Procedure|Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M|
12045171|NCT00243477|Drug|Escitalopram|Escitalopram 10mg or placebo once a day
12045172|NCT00243464|Drug|Calcipotriol plus betamethasone dipropionate (LEO80185 gel)|
12045173|NCT00243451|Other|PET scan & fMRI|Subjects will be screened and if applicable for the study will be scheduled for an MRI. At the third visit they will complete the PET scan. They will return at 6, 12, 24, and 36 months and complete another PET scan at the last visit.
12045174|NCT00243438|Device|Multilink Vision™ Stent (CE-labeled)|Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.
12045175|NCT00243425|Procedure|Standard Quality Improvement|
12045176|NCT00243425|Procedure|Patient-centered Intervention|
12045177|NCT00243412|Drug|folate|Minimum of 1 mg/day oral (or folinic acid 5 mg/week)
12045178|NCT00243412|Drug|methotrexate|15-25 mg/week oral or parenteral (10-14 mg/week if intolerant)
12045179|NCT00243412|Drug|methylprednisolone|100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion)
12045180|NCT00243412|Drug|Placebo|To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18.
12045181|NCT00243412|Drug|Rituximab|500 mg or 1000 mg IV*2.
12045182|NCT00243399|Drug|Oxandrolone|Subjects will be started on a dose of oxandrolone 0.04 mg/kg/day orally, once/day. After 16 weeks, patients will be assessed for hematologic improvement. If this criteria is not met after 16 weeks, the dose will be escalated to 0.08 mg/kg/day. If no improvement is noted after 16 weeks on the escalated dose, oxandrolone therapy will be discontinued.
12045183|NCT00243386|Drug|Antihemophilic factor, recombinant, manufactured protein-free|Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator
12045184|NCT00243386|Drug|Antihemophilic factor, recombinant, manufactured protein-free|PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data
12045185|NCT00243373|Device|Barcode technology/eMAR|
12045186|NCT00243360|Behavioral|diagnostic and treatment clinical algorithms|
12045187|NCT00243347|Drug|AZD2171|oral tablet
12045188|NCT00243334|Other|Integration of advanced clinical decision support with ambulatory computerized physician order entry|Actiobable Reminders related to medication monitoring, preventive care and chronic disease management, and test result follow-up are administered either during the visit or between visits.
12045189|NCT00243321|Procedure|high dose-rate brachytherapy|High dose-rate brachytherapy
12045190|NCT00243321|Procedure|intensity-modulated radiation therapy|intensity-modulated radiation therapy
12045191|NCT00243308|Drug|Serine proteinase-1 (Serp-1)|
12045192|NCT00243295|Drug|rhBMP-2/CPM|
12045193|NCT00243282|Behavioral|Relaxation Response (instruction, pocket practice card prov)|
12045194|NCT00243282|Behavioral|Mindfulness training using model developed from UMass|
12045195|NCT00243269|Behavioral|Acupressure expectancy enhancement|"This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.
~This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea."
12045196|NCT00243256|Drug|Cholecalciferol|
12045197|NCT00243243|Drug|Recombinant Factor VIIa|intravenous infusion of Factor VIIa
12045198|NCT00243243|Drug|Placebo|intravenous infusion of placebo (sterile water)
12045199|NCT00243230|Drug|Vicriviroc maleate 20 mg|Two tablets of vicriviroc maleate 10 mg and one tablet of placebo once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc.
12045200|NCT00243230|Drug|Vicriviroc maleate 30 mg|Three tablets of vicriviroc maleate 10 mg once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc.
12045201|NCT00243230|Drug|Placebo|Three tablets of placebo once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc
12045202|NCT00243217|Drug|SPM 936|
12045203|NCT00243204|Drug|talabostat mesylate|
12045204|NCT00243204|Drug|docetaxel|
12045205|NCT00243191|Drug|imatinib mesylate|400 mg orally twice a day for 10 - 14 days
12045206|NCT00243178|Drug|clopidogrel (SR25990C)|75 mg once daily in combination with aspirin
12045207|NCT00243165|Behavioral|Lifemel honey intake every day|
12045208|NCT00243152|Drug|Lamotrigine|: 25mg and 50mg tablets
12045209|NCT00243152|Drug|Placebo (for Lamotrigine)|Sugar pill manufactured to mimic Lamotrigine tablets
12045210|NCT00243139|Device|Mandibular advancement device (activator)|
12045211|NCT00243126|Behavioral|Family-Based Risk Reduction Intervention|The intervention module topics include five modules and each module is 2 hours in length. The intervention will focus on the elements critical to HIV risk behavior change. These include: risk education (practical understanding of factors responsible for risk and behavior changes needed to reduce risk); threat personalization (accurate appraisal of personal risk based on behavior); self-efficacy (belief that one can implement risk reduction behavior changes and that if changes are made they will have protective value); skills acquisition (e.g., condom use, safer sex guidance, negotiation); cognitive problem-solving skills; and reinforcement.
12045212|NCT00243113|Drug|docetaxel|
12045213|NCT00243113|Radiation|radiation therapy|
12045214|NCT00243100|Drug|vorinostat|Given orally
12045215|NCT00243100|Drug|gemcitabine hydrochloride|Given IV
12045216|NCT00243087|Drug|BI 2536|
12045217|NCT00243074|Drug|cediranib maleate|Given orally
12045218|NCT00243074|Other|laboratory biomarker analysis|Correlative studies
12045219|NCT00243061|Drug|cediranib maleate|Given orally
12045220|NCT00243048|Dietary Supplement|soy protein isolate|
12045221|NCT00243048|Radiation|radiation therapy|
12045222|NCT00243035|Drug|bortezomib|Given IV
12045223|NCT00243035|Drug|tipifarnib|Given orally
12045224|NCT00243035|Other|laboratory biomarker analysis|Correlative studies
12045229|NCT00243009|Drug|mycophenolate mofetil|
12045230|NCT00243009|Procedure|allogeneic bone marrow transplantation|
12045231|NCT00243009|Procedure|peripheral blood stem cell transplantation|
12045232|NCT00243009|Radiation|radiation therapy|
12045233|NCT00242996|Biological|filgrastim|
12045234|NCT00242996|Biological|rituximab|
12045235|NCT00242996|Biological|sargramostim|
12045236|NCT00242996|Drug|carmustine|
12045237|NCT00242996|Drug|cyclophosphamide|
12045238|NCT00242996|Drug|etoposide|
12045239|NCT00242996|Procedure|adjuvant therapy|
12045240|NCT00242996|Procedure|bone marrow ablation with stem cell support|
12045241|NCT00242996|Procedure|peripheral blood stem cell transplantation|
12045242|NCT00242983|Procedure|quality-of-life assessment|
12045243|NCT00242970|Device|3-Dimensional Color Scanning|Color imaging of the face and neck.
12045244|NCT00242957|Behavioral|Intervention with Microfinance for AIDS and Gender Equity|
12045245|NCT00242944|Drug|Pitavastatin|Pitavastatin 4mg per day
12045246|NCT00242944|Drug|Atorvastatin|Atorvastatin 20mg per day
12045247|NCT00242931|Other|Nonmyeloablative stem cell conditioning regimen|"Conditioning:
~Fludarabine 30 mg/m2/day x 3, day -4 to day -2 TBI 200 cGy x 1, day 0
~Hematopoeitic Stem Cell Transplantation:
~Infusion of peripheral blood stem cells, day 0
~Immunosuppression:
~For related donors: cyclosporine (CSP) 5 mg/kg p.o. bid, day -3 to day +56, then taper by 20% every 5 days to be completed by day +81 For related donors: mycophenolate mofetil (MMF) 15 mg/kg p.o. q 12 hours, day 0 to day +27, then stop
~For unrelated donors: cyclosporine (CSP) 5 mg/kg p.o. bid, day -3 to day +56, then taper by 20% every 5 days to be completed by day +81 For unrelated donors: mycophenolate mofetil (MMF) 15 mg/kg tid day +0 to day +29, 15 mg/kg bid day +30 to day +149, and then taper by 25% per week from day +150 to day +180. Discontinue by day +181."
12045248|NCT00242918|Drug|docetaxel|
12045249|NCT00242918|Drug|ZD1839|
12045250|NCT00242905|Behavioral|Study of memory using MRI|Study of memory using MRI
12045251|NCT00242892|Procedure|Intra coronary measures of pressure|Intra coronary measures of pressure
12045252|NCT00242879|Drug|Physician determined comparator PI + ritonavir|
12045253|NCT00242879|Drug|GW640385 + ritonavir|
12045254|NCT00242866|Drug|GW274150|The tablets used in this study will contain either 5mg or 30mg of GW274150
12045255|NCT00242866|Other|Placebo|Placebo to Match GW274150
12045256|NCT00242853|Procedure|Power doppler ultrasonography|
12045257|NCT00242853|Procedure|High frequency ultrasonography|
12045258|NCT00242853|Procedure|Exhaled nitric oxide assessment|
12045259|NCT00242840|Drug|No intervention; Observational study|
12045260|NCT00242827|Drug|Oral CEP-701|
12045261|NCT00242814|Drug|Micardis|
12045262|NCT00242814|Drug|Amlodipine|
12045263|NCT00242814|Procedure|Abdominal biopsy|
12045264|NCT00242801|Drug|Gefitinib|
12045265|NCT00242788|Drug|Gefitinib and capecitabine|
12045266|NCT00242775|Drug|Budesonide/formoterol Turbuhaler|
12045267|NCT00242775|Drug|Salmeterol/fluticasone Diskus|
12045268|NCT00242762|Drug|ZD1839 (IRESSA™)|
12045269|NCT00242762|Drug|Docetaxel|
12045270|NCT00242762|Drug|Cisplatin|
12045271|NCT00242749|Drug|Gefitinib, Cisplatin and Radiotherapy|
12045272|NCT00242736|Drug|Esomeprazole|
12045273|NCT00242710|Drug|Bazedoxifene/Conjugated Estrogen|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
12045274|NCT00242710|Drug|Bazedoxifene/Conjugated Estrogen|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
12045275|NCT00242710|Drug|CE 0.45 mg/MPA 1.5mg|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
12045276|NCT00242710|Other|Placebo|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
12045277|NCT00242697|Procedure|spinal analgesia and anesthesia for coronary artery surgery|
12045278|NCT00242671|Procedure|Isocapnic Hyperponea|
12045279|NCT00242658|Behavioral|Tailored Physical Activity Intervention|Tailored physical activity computer reports will be provided to patients and physicians.
12045280|NCT00242645|Behavioral|Health Information|
12045281|NCT00242645|Behavioral|Preventive Services|
12045282|NCT00242645|Behavioral|Computer tailored information|
12045283|NCT00242632|Drug|Namenda|Namenda has already been shown to offer cognitive benefits to patients suffering from Alzheimer's disease, but it's potential for treating those at risk for cognitive decline without Alzheimer's disease or other dementia has yet to be evaluated. It is possible that memantine may offer neurocognitive benefits to this population, as well. Participants are asked to take medication for six months, complete neuropsychological testing, and one blood draw.
12045284|NCT00242619|Drug|rosiglitazone|Rosiglitazone was administered at two different doses over the 12-week period.
12045285|NCT00242606|Drug|Lamotrigine|titrate to 200mg over 10 weeks and maintained until end of week 26
12045286|NCT00242606|Drug|Levetiracetam|titrate to 2000mg/day over 22 days, maintain until the end of week 26
12045287|NCT00242593|Drug|Rosiglitazone|4 mg twice daily oral rosiglitazone or placebo pill for 18 months
12045288|NCT00242580|Drug|Verteporfin photodynamic therapy|After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.
12045289|NCT00242580|Drug|Pegaptanib|Pegaptanib sodium 0.3 mg administered by intravitreal injection.
12045290|NCT00242580|Drug|Triamcinolone acetonide|Triamcinolone acetonide administered by intravitreal injection.
12045351|NCT00241969|Behavioral|Education and Attention Control|This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
12045352|NCT00241943|Procedure|Hepatitis C educational video|
12045353|NCT00241930|Behavioral|Integrating drug treatment into HIV services|
12045291|NCT00242567|Drug|Zoledronic Acid|"Zoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration.
~After addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours.
~The infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes."
12045292|NCT00242567|Drug|Androgen Deprivation Therapy (ADT)|Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study.
12045293|NCT00242554|Drug|Zoledronic acid|
12045294|NCT00242541|Drug|Octreotide acetate|
12045295|NCT00242528|Drug|Zoledronic acid|
12045296|NCT00242515|Procedure|CD8+ T-cell depleted donor lymphocyte infusion|
12045297|NCT00242502|Drug|Bevacizumab (Avastin)|10 mg/kg IV every 14 days, repeat cycle every 28 days
12045298|NCT00242502|Drug|Erlotinib|150 mg orally every day continuous dosing, repeat cycle every 28 days
12045299|NCT00242489|Drug|MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)|
12045300|NCT00242489|Drug|Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks|
12045301|NCT00242476|Drug|MK0822A|
12045302|NCT00242463|Drug|Nandrolone (anabolic steroid)|
12045303|NCT00242463|Drug|Placebo|
12045304|NCT00242450|Drug|Metoclopramide|
12045305|NCT00242437|Device|Hemostatic matrix|
12045306|NCT00242437|Device|bovine thrombin|
12045307|NCT00242424|Biological|2005-2006 trivalent inactivated influenza vaccine|Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines. Second dose administered 4 weeks later.
12045308|NCT00242411|Drug|Budesonide/Formoterol Turbuhaler|
12045309|NCT00242411|Drug|Conventional Best Asthma Therapy|
12045310|NCT00242398|Device|AN69 ST|
12045311|NCT00242385|Biological|Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor|Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
12045312|NCT00242385|Biological|Dose of 60 mg/kg alpha1-proteinase inhibitor|Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
12045313|NCT00242372|Drug|Tesaglitazar 0.5|
12045314|NCT00242372|Drug|Insulin at least 30 units/day|
12045315|NCT00242359|Drug|omalizumab|
12045316|NCT00242346|Drug|candesartan cilexetil|
12045317|NCT00242333|Drug|AD 237|
12045318|NCT00242320|Drug|Roflumilast|to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
12045319|NCT00242320|Drug|Placebo|
12045320|NCT00242307|Drug|Roflumilast|
12045321|NCT00242294|Drug|Roflumilast|
12045322|NCT00242281|Drug|APC-111 MP Tablet, 775 mg|
12045323|NCT00242268|Drug|Simvastatin|
12045324|NCT00242229|Drug|DVS-233 SR|
12045325|NCT00242216|Drug|ritonavir-boosted atazanavir|100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
12045326|NCT00242216|Drug|ritonavir-boosted fosamprenavir|100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
12045327|NCT00242203|Drug|Zometa|
12045328|NCT00242203|Drug|Epirubicin|
12045329|NCT00242203|Drug|Docetaxel|
12045330|NCT00242203|Drug|Trastuzumab|ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH
12045331|NCT00242203|Radiation|External beam radiation|
12045332|NCT00242203|Procedure|Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection|
12045333|NCT00242190|Drug|oxaliplatin|
12045334|NCT00242190|Drug|gemcitabine|
12045335|NCT00242190|Procedure|radiation therapy|
12045336|NCT00242177|Drug|ACTOS (Pioglitazone)|
12045337|NCT00242164|Drug|Dialysate Magnesium (Concentration)|
12045338|NCT00242138|Behavioral|Erectile Dysfunction|
12045339|NCT00242112|Procedure|MRI Prostate|
12045340|NCT00242099|Procedure|Monitoring - blood samples drawn to test for HHV-6 and HHV-7|
12045341|NCT00242086|Procedure|CT, PET and MRI|
12045342|NCT00242073|Procedure|MRI Prostate|
12045343|NCT00242060|Procedure|MRI|
12045344|NCT00242047|Biological|Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).|
12045345|NCT00242034|Procedure|CT and MRI with contrast|
12045346|NCT00242021|Behavioral|Fatty acid composition of a margarine (spread)|
12045347|NCT00242008|Drug|Rotigotine|
12045348|NCT00241995|Drug|Anticonvulsants|
12045349|NCT00241982|Drug|long-circulating liposomal prednisolone|
12045350|NCT00241969|Behavioral|Behavioral and Nutrition Treatment|This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills. The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
12045461|NCT00240825|Drug|Acetaminophen|
12045354|NCT00241917|Behavioral|Hepatitis C educational video|
12045355|NCT00241917|Other|Video|Prevention education video about hepatitis C
12045356|NCT00241904|Behavioral|Lifestyle Changes|Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise
12045357|NCT00241904|Drug|Antiplatelet Agents|Aspirin 81 mg q day
12045358|NCT00241904|Drug|Beta Blocker|Oral medication
12045359|NCT00241904|Drug|ACE Inhibitors|Oral medications, received 1-2 times per day
12045360|NCT00241891|Behavioral|Single behavior intervention|Focused on changing beverage choices which may have a significant impact on weight.
12045361|NCT00241891|Behavioral|Multiple behavior interventions|Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
12045362|NCT00241891|Behavioral|Control Intervention unrelated to weight|Focused on standard intervention strategies unrelated to weight including bullying prevention.
12045363|NCT00241878|Behavioral|Teacher-Delivered Weight Control Intervention|The teacher-delivered weight control intervention (TD-WCI) is implemented over 14 weeks with three lessons per week. Many lessons include the use of colorful, friendly, hand-made puppets that represent the seven food groups of the food pyramid (Miss Grain, Miss Fruit, Mr. Vegetable, Mr. Protein, Miss Dairy, Mr. Fat and Miss Sugar). Please see Appendix IX for complete curriculum and pictures of puppets. There are three 40-minute lessons per week that consist of a 15-20 minutes interactive healthy eating and exercise didactic session and then 20 minutes of ongoing physical activity (5 minutes warm-up, 15 minutes aerobic activity composed of a number of games and dances with music, 5 minutes cool-down). In addition to the child-based curriculum the WCI has parent newsletters. These newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum
12045364|NCT00241878|Behavioral|Teacher-Delivered General Health Intervention|The teacher-delivered general health intervention (TD-GHI) serves as the control group in the proposed study. TD-GHI is a general health intervention that is similar in structure and length to TD-WCI. Topics include those related to general health and safety, such as car safety, being a good friend, poison safety, disease prevention, etc. An example of an activity is the 911 emergency call. The children learn what 911 is and what would be an appropriate call. They then practice calling 911 on play telephones and relating the important information: nature of the emergency, their name, their address, etc. They learn also to stay on the phone with the 911 dispatcher until someone comes to help them. In addition to the child-based curriculum the GHI has parent newsletters. Like TD-WCI these newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum
12045365|NCT00241852|Behavioral|Asthma: It's a Family Affair!|Intervention families will receive a comprehensive program with two complementary components: (1) a school-based intervention to empower middle school students to manage their asthma and (2) parent training to teach their caregivers childrearing skills that support the youth's growing autonomy and need to self-manage their disease. The student component is comprised of 6, 60 minute group workshops; the caregiver component consists of 5, 90-minute group workshops.
12045366|NCT00241852|Behavioral|Asthma and Stress Comparator|Caregivers assigned to the Asthma and Stress Comparator group will receive a single educational workshop focusing on the developmental changes adolescents experience, how these changes may cause stress, and ways to cope with stress. The children will also participate in a single school-based session on similar topics. Both caregivers and students will learn basic asthma facts.
12045367|NCT00241839|Drug|Allopurinol|Allopurinol (300 mg capsule) was given for 8-10 weeks compared to placebo group after initial baseline testing. After two weeks on the Allopurinol, a serum uric acid level was obtained. If the uric acid level was greater than 5.5, the Allopurinol dosage was increased to 600mg (two 300 mg capsules)for the duration of the trial, 6-8 weeks.
12045368|NCT00241839|Drug|Placebo|Placebo capsule (matched in appearance for Allopurinol and labeled 300mg) was given for 8-10 weeks compared to the Allopurinol group after initial baseline testing. After two weeks on the placebo, a serum uric acid level was obtained. If the uric acid level was greater than 5.5, the placebo dosage was increased to 600mg (two 300 mg capsules)for the duration of the study, 6-8 weeks.
12045369|NCT00241839|Drug|Chlorthalidone|Chlorthalidone 25 mg was given daily for 5 weeks before baseline visit for testing and continued through out the study.
12045370|NCT00241839|Drug|Potassium chloride|Potassium Chloride 40-50meq was given daily for 5 weeks before baseline visit for testing and continued through out the study.
12045371|NCT00241826|Procedure|Magnetic Resonance Angiography|Participants will undergo magnetic resonance angiography.
12045372|NCT00241826|Procedure|Magnetic Resonance Venography|Participants will undergo magnetic resonance venography.
12045373|NCT00241813|Behavioral|Mindfulness Meditation (MM) Program|Participants will take part in a mindfulness meditation (MM) program.
12045374|NCT00241813|Behavioral|Health Education Control Program (CTL)|Participants will take part in a health education control program (CTL)
12045375|NCT00241813|Behavioral|Lifeskills Program (LP)|Participants will take part in a lifeskills program (LP).
12045376|NCT00241722|Drug|Alvimopan|
12045377|NCT00241722|Drug|Placebo|
12045378|NCT00241670|Drug|5-aminolevulinic acid (5-ALA)|1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery
12045379|NCT00241657|Biological|BCG|
12045380|NCT00241644|Biological|Rotarix™|Two or Three doses, oral administration
12045381|NCT00241644|Biological|Placebo|One or three doses, oral administration.
12045382|NCT00241631|Drug|Fluticasone Propionate|500 u
12045383|NCT00241631|Drug|placebo|
12045384|NCT00241631|Drug|Theophylline|Theophylline placebo capcule
12045385|NCT00241618|Drug|Pegylated interferon alpha 2|
12045386|NCT00241618|Drug|Ribavirin|
12045387|NCT00241605|Drug|rosiglitazone/metformin|
12045388|NCT00241592|Drug|Cannabis|
12045389|NCT00241579|Drug|Smoked Cannabis|
12045390|NCT00241566|Device|implantation of stimulator|
12045391|NCT00241553|Drug|Esomeprazole|
12045392|NCT00241540|Drug|Esomeprazole|
12045393|NCT00241527|Drug|Esomeprazole|
12045394|NCT00241514|Drug|Esomeprazole|
12045395|NCT00241501|Drug|Esomeprazole (Nexium)|
12045396|NCT00241488|Drug|Rosuvastatin|
12045397|NCT00241475|Drug|Gefitinib|
12045398|NCT00241449|Drug|Fulvestrant|intramuscular injection 250 mg
12045399|NCT00241449|Drug|Tamoxifen|20 mg oral tablet
12045400|NCT00241436|Drug|Anastrozole (ARIMIDEX™)|
12045401|NCT00241423|Drug|exenatide|subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week
12045402|NCT00241423|Drug|Placebo|subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week
12045403|NCT00241410|Biological|OralvacB2MPL|Comparison of different dosages of drug
12045404|NCT00241384|Procedure|External beam radiation|
12045405|NCT00241384|Procedure|Pd-103|
12045406|NCT00241371|Drug|Clofarabine|
12045407|NCT00241358|Drug|AMD3100|
12045408|NCT00241358|Procedure|Stem Cell Transplant|
12045409|NCT00241345|Drug|Valganciclovir|
12045410|NCT00241345|Drug|Ganciclovir|
12045411|NCT00241332|Drug|fentanyl|
12045412|NCT00241319|Drug|R89674 (generic name not yet established)|
12045413|NCT00241280|Device|etafilcon A|
12045414|NCT00241280|Device|galyfilcon A|
12045415|NCT00241267|Device|Dedicated ultrasonographic probe during bronchoscopy|
12045416|NCT00241254|Drug|Cyclophosphamide (drug)|IV cyclophosphamide infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
12045417|NCT00241254|Drug|Methylprednisolone (drug)|Control group : IV methylprednisolone infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
12045418|NCT00241241|Drug|pegylated interferon-alfa 2a|
12045419|NCT00241228|Device|Venovenous haemofiltration (renal replacement therapy)|High Volume ultra filtration (70 ml/kg/h)
12045420|NCT00241228|Device|Venovenous haemofiltration (renal replacement therapy)|Conventional Volume (35 ml/kg/h)
12045421|NCT00241215|Drug|Botulinum toxin serotype A|
12045422|NCT00241202|Behavioral|Symptom Management Manual|Participants receive the Symptom Management Manual, and are shown an example. They are given the Manual to take home with them and use.
12045423|NCT00241189|Drug|rapamycin|
12045424|NCT00241189|Drug|methotrexate|
12045425|NCT00241176|Drug|Aripiprazole|Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS & CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day
12045426|NCT00241163|Procedure|Fibrinogen (human) + thrombin (human) (TachoSil)|
12045427|NCT00241150|Drug|VALSARTAN|
12045428|NCT00241137|Drug|valsartan|
12045429|NCT00241124|Drug|valsartan|
12045430|NCT00241124|Drug|lisinopril|
12045431|NCT00241111|Drug|zoledronic acid|
12045432|NCT00241098|Drug|valsartan|
12045433|NCT00241085|Drug|valsartan|
12045434|NCT00241072|Drug|valsartan|24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)
12045435|NCT00241059|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045436|NCT00241046|Drug|Letrozole|
12045437|NCT00241020|Drug|Octreotide|
12045438|NCT00241007|Drug|VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE|
12045439|NCT00240994|Drug|Alemtuzumab|Administered intravenously over a period of 2-3 hours. Two doses total, the first will be one day before transplant and the second will be on the day following transplantation. Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose.
12045440|NCT00240994|Drug|Tacrolimus|Administered orally at a dose of 0.05-0.1 mg/kg twice daily, beginning 1-3 days following transplantation and continuing until weeks 8-12. Tacrolimus will be discontinued and a treatment regimen with sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.
12045441|NCT00240994|Drug|Mycophenolate mofetil|Per recommendation
12045442|NCT00240994|Drug|Sirolimus|Administered by either liquid or tablet every 12 hours from month 6 until month 24. Dosage will vary throughout the treatment course.
12045443|NCT00240981|Drug|Topical testosterone gel 1% (active formulation)|Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
12045444|NCT00240981|Drug|Topical gel (placebo formulation)|Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
12045445|NCT00240968|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|A monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit¿¿dose vials containing either 30-mcg/mL A/H5N1 HA or 90-mcg/mL A/H5N1 HA. Subjects will receive 1 of 4 dose levels of vaccine (7.5, 15, 45, or 90 mcg) administered intramuscularly.
12045446|NCT00240955|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12045447|NCT00240942|Drug|Letrozole|
12045448|NCT00240929|Drug|MEDI-493|Active Comparator
12045449|NCT00240916|Biological|Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous)|
12045450|NCT00240916|Biological|MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)|
12045451|NCT00240903|Biological|Influenza A/Vietnam/1203/2004 (H5N1; sanofi pasteur)|
12045452|NCT00240877|Biological|AV024|0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
12045453|NCT00240877|Other|Placebo|Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
12045454|NCT00240864|Drug|placebo|
12045455|NCT00240864|Drug|acetaminophen|
12045456|NCT00240864|Drug|ibuprofen|
12045457|NCT00240851|Drug|acetaminophen extended release|
12045458|NCT00240838|Drug|acetaminophen extended release caplets|
12045459|NCT00240825|Drug|Ibuprofen|
12045460|NCT00240825|Drug|Placebo|
12045462|NCT00240812|Drug|ibuprofen; pseudoephedrine HCl|
12045463|NCT00240799|Drug|acetaminophen extended release|
12045464|NCT00240799|Drug|placebo|
12045465|NCT00240786|Drug|acetaminophen extended release|
12045466|NCT00240773|Drug|acetaminophen|4 grams daily for six months
12045467|NCT00240773|Drug|naproxen|750 mg daily for 12 months
12045468|NCT00240773|Drug|acetaminophen|4 grams daily for 12 months
12045469|NCT00240773|Drug|naproxen|750 mg daily for six months
12045470|NCT00240760|Drug|Memantine Hydrochloride|
12045471|NCT00240747|Drug|Synercid|
12045472|NCT00240734|Drug|Epoetin alfa|
12045473|NCT00240721|Drug|topiramate|
12045474|NCT00240708|Drug|risperidone|
12045475|NCT00240695|Drug|galantamine hydrobromide|
12045476|NCT00240682|Drug|cetuximab|Dosage form: bottles of 50 ml, 2 mg/ml; Dosage:400 mg/m2 initial dose followed by 250 mg/m2 by infusion every week; Number of Cycles : until progression or unacceptable toxicity develops.
12045477|NCT00240669|Device|Resorbable device PLLA/PGA|
12045478|NCT00240669|Device|Titanium device|
12045479|NCT00240656|Drug|spironolactone captopril carvedilol|
12045480|NCT00240643|Drug|SB424323|
12045481|NCT00240630|Drug|sumatriptan succinate/naproxen sodium|Combination Tablet of Treximet
12045482|NCT00240630|Drug|placebo|placebo to match
12045483|NCT00240617|Drug|sumatriptan succinate/naproxen sodium|comparator
12045484|NCT00240617|Drug|placebo|placebo to match
12045485|NCT00240604|Drug|Rosiglitazone|4 mg rosiglitazone per day
12045486|NCT00240565|Drug|Tositumomab 450 mg|Unlabeled TST
12045487|NCT00240565|Drug|Tositumomab 35 mg|TST labeled with 185 megaBecqueral (mbq) of iodine 131
12045488|NCT00240552|Drug|fosamprenavir|
12045489|NCT00240552|Drug|Telzir®|
12045490|NCT00240539|Procedure|Blood sampling|A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine.
12045491|NCT00240526|Biological|Engerix™ -B|3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
12045492|NCT00240526|Biological|Hepatitis B immunoglobulin (HBIg)|1 intramuscular injections at birth (primary study)
12045493|NCT00240513|Drug|Minocycline|100 mg capsules OD for 3 months
12045494|NCT00240513|Drug|Minocycline plus tretinoin|100mg OD Minocycline for 12 weeks plus OD Topical tretinoin 0.01% for 12 weeks Followed by topical tretinoin 0.01% OD for 12 weeks alone
12045495|NCT00240500|Biological|Engerix™-B|In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.
12045496|NCT00240487|Drug|Nitric Oxide|Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.
12045497|NCT00240487|Other|No Intervention|Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.
12045498|NCT00240474|Drug|Telmisartan 80 mg + hydrochlorothiazide 12.5 mg|
12045499|NCT00240474|Drug|Amlodipine 10 mg + hydrochlorothiazide 12.5 mg|
12045500|NCT00240461|Dietary Supplement|COLD-fX natural health product|200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
12045501|NCT00240461|Dietary Supplement|COLD-fX|400 mg COLD-fX natural health product 2 times daily for 6 months
12045502|NCT00240461|Other|Placebo|crystalline substance 200 mg twice daily for 6 months
12045503|NCT00240448|Drug|telmisartan 80 mg/hydrochlorothiazide 25 mg|
12045504|NCT00240448|Drug|valsartan 160 mg/hydrochlorothiazide 25 mg|
12045505|NCT00240448|Drug|placebo|
12045506|NCT00240435|Device|5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
12045507|NCT00240435|Device|10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
12045508|NCT00240422|Drug|Telmisartan|
12045509|NCT00240422|Drug|Ramipril|
12045510|NCT00240409|Drug|Pramipexole|
12045511|NCT00240409|Drug|Bromocriptine|
12045512|NCT00240396|Drug|Narcotics alone|
12045513|NCT00240396|Drug|Narcotics and NSAIDS|
12045514|NCT00240383|Drug|Muraglitazar|
12045515|NCT00240370|Drug|Muraglitazar|
12045516|NCT00240357|Procedure|Lifestyle Regulation|
12045517|NCT00240331|Drug|10mg Rosuvastatin|
12045518|NCT00240331|Drug|Placebo|
12045519|NCT00240318|Drug|Rosuvastatin calcium|
12045520|NCT00240305|Drug|Rosuvastatin|
12045521|NCT00240292|Drug|Rosuvastatin|
12045522|NCT00240279|Drug|Rosuvastatin|
12045523|NCT00240279|Procedure|aortic pulse wave velocity measurements|
12045524|NCT00240266|Drug|Rosuvastatin|
12045525|NCT00240253|Drug|pramlintide acetate|Clear, colorless, sterile solution for SC injection
12045526|NCT00240227|Drug|Prazosin|FDA approved medication for hypertension
12045527|NCT00240227|Drug|placebo|
12045528|NCT00240214|Drug|sirolimus|Tablet, dosage is determined by trough level
12045529|NCT00240188|Procedure|Open mesh repair of ventral incisional hernia|For the open procedure, the technique, as described by Chevrel and others was adopted.
12045530|NCT00240188|Procedure|Laparoscopic mesh repair of ventral incisional hernia|For the laparoscopic repair, the method of Gagner was adopted
12045531|NCT00240175|Other|No Intervention|No Intervention
12045532|NCT00240162|Drug|PTK787/ZK 222584|
12045533|NCT00240149|Drug|Regular Insulin via Insulin-Glucose Algorithm|
12045534|NCT00240123|Drug|Benadryl versus Placebo|
12045535|NCT00240110|Drug|Valproate|Valproate with dose titration to achieve blood levels within the therapeutic range
12045536|NCT00240110|Drug|Placebo|Control arm
12045537|NCT00240110|Drug|Lithium Carbonate|All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder
12045674|NCT00238914|Behavioral|Behavioral Naltrexone Therapy (BNT)|a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy
12045538|NCT00240097|Drug|Intervention A: Irinotecan; Oxaliplatin; Neulasta|Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
12045539|NCT00240097|Drug|Intervention B: Etoposide; Carboplatin; Neulasta|Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
12045540|NCT00240084|Drug|nesiritide (Natrecor(TM))|administration of IV nesiritide
12045541|NCT00240071|Drug|Avastin|All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.
12045542|NCT00240071|Drug|Hormonal therapy|aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)
12045543|NCT00240058|Drug|Regional phenylephrine arterial infusion, Nitric Oxide Clamp|
12045544|NCT00240045|Drug|Midodrine, albumin, octreotide LAR|
12045545|NCT00240045|Drug|midodrine, octreotide, albumin|midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly
12045546|NCT00240032|Drug|glatiramer acetate injection with oral cetirizine hydrochloride|Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
12045547|NCT00240032|Drug|glatiramer acetate with placebo|Copaxone® injection 20 mg, oral placebo
12045548|NCT00240019|Drug|Addition of furosemide 20 mg oral bid to baseline regimen|
12045549|NCT00240006|Procedure|Shared Solutions® plus MS Center v. Shared Solutions®|Copaxone
12045550|NCT00239993|Drug|glatiramer acetate|
12045551|NCT00239993|Procedure|Warm compress prior to injection of glatiramer acetate|
12045552|NCT00239980|Drug|dalteparin|50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
12045553|NCT00239967|Drug|Rimonabant (SR141716)|
12045554|NCT00239967|Drug|Placebo|
12045555|NCT00239954|Drug|Escitalopram|
12045556|NCT00239928|Drug|pegaptanib sodium|1 drop per dosed eye per protocol.
12045557|NCT00239915|Drug|Pagoclone|
12045558|NCT00239902|Drug|FTY720|
12045559|NCT00239889|Drug|Salmon calcitonin|
12045560|NCT00239876|Drug|FTY720|
12045561|NCT00239863|Drug|FTY720|
12045562|NCT00239850|Behavioral|lifestyle changes|
12045563|NCT00239837|Behavioral|Middle School Success Intervention (MSS)|This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school.
12045564|NCT00239824|Behavioral|Strength training of the pelvic floor muscles|"Group A followed a pelvic floor muscle exercise course consisting of intensive pelvic floor muscle training with follow up instructions (training group or DVD instructions)by a physiotherapist;3 x 10 contractions daily.
~Group B were instructed to train the pelvic floor muscles 3 x 10 contractions daily without follow up instructions by a physiotherapist."
12045565|NCT00239824|Behavioral|strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist|
12045566|NCT00239811|Drug|FTY720|
12045567|NCT00239798|Drug|FTY720|
12045568|NCT00239785|Drug|FTY720|
12045569|NCT00239772|Behavioral|Cognitive Processing Therapy|
12045570|NCT00239772|Behavioral|Prolonged Exposure Therapy|
12045571|NCT00239746|Drug|Ibuprofen|200mg taken orally daily for 6-12 weeks
12045572|NCT00239746|Drug|Placebo|200mg matched placebo taken orally daily for 6-12 weeks
12045573|NCT00239733|Drug|Anti-D|30-minute infusion administered in an outpatient setting
12045574|NCT00239720|Drug|hOKT3gamma1(Ala-Ala)|Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle
12045575|NCT00239720|Drug|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
12045576|NCT00239707|Drug|GIP|One-time 20 ng/kg/min infusion over 3 hours
12045577|NCT00239707|Drug|Modified GIP|One-time infusion over 3 hours; dose to maintain desired biological effect of below 140 mg/dl
12045578|NCT00239707|Drug|Normal Saline|one-time infusion over 3 hours
12045579|NCT00239694|Biological|Pneumococcal Vaccine|One time preventative vaccine
12045580|NCT00239694|Biological|Meningococcal Vaccine|One time preventative vaccine
12045581|NCT00239681|Drug|Rosuvastatin|Oral
12045582|NCT00239681|Other|Placebo|Oral
12045583|NCT00239655|Drug|MK0812|
12045584|NCT00239642|Drug|Venofer (iron sucrose injection)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
12045585|NCT00239642|Drug|Venofer (iron sucrose injection)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
12045586|NCT00239642|Drug|Venofer (iron sucrose injection)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
12045587|NCT00239629|Drug|Teriparatide|
12045588|NCT00239629|Drug|Strontium ranelate|
12045589|NCT00239629|Procedure|Transiliac bone biopsy|
12045590|NCT00239616|Drug|iron sucrose injection USP|
12045591|NCT00239603|Device|OV-Watch|
12045592|NCT00239590|Drug|Testosterone undecanoate|Licensed for androgen deficiency
12045593|NCT00239577|Biological|Live attenuated tetravalent dengue vaccine|Live attenuated tetravalent dengue vaccine
12045594|NCT00239577|Biological|Placebo|Placebo
12045595|NCT00239564|Drug|IPX054 100 mg|IPX054 containing 25 mg carbidopa and 100 mg levodopa
12045596|NCT00239564|Drug|IPX054 150 mg|IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
12045597|NCT00239564|Drug|IPX054 200 mg|CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
12045598|NCT00239564|Drug|IPX054 250 mg|CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
12045599|NCT00239564|Drug|IPX054 300 mg|CD-LD CR containing 75 mg carbidopa and 300 mg levodopa
12045675|NCT00238914|Behavioral|Compliance Enhancement (CE)|a controlled therapy intended to simulate outpatient psychiatric care.
12045600|NCT00239551|Drug|Prevacid|Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 & EGD with biopsy at 8 weeks
12045601|NCT00239538|Drug|telmisartan combined with hydrochlorothiazide (80/12.5 mg)|
12045602|NCT00239538|Drug|valsartan combined with hydrochlorothiazide (160/12.5mg)|
12045603|NCT00239525|Device|3-D ultrasound scanner|The availability of color flow Doppler combined with effective ultrasound contrast agents in transcranial sonography serves as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull.
12045604|NCT00239525|Drug|Perflutren Protein-Type A Microspheres for injection|Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Bolus: The recommended dose for activated DEFINITY® is 10 microliters (μL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (μL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.
12045605|NCT00239512|Drug|Indomethacin and Ibuprofen|
12045606|NCT00239499|Drug|Tiotropium|
12045607|NCT00239499|Drug|Salmeterol plus Fluticasone|
12045608|NCT00239486|Drug|Pramipexole|
12045609|NCT00239473|Device|5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
12045610|NCT00239473|Device|10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
12045611|NCT00239460|Drug|Tiotropium|
12045612|NCT00239447|Drug|Tiotropium|
12045613|NCT00239447|Device|HandiHaler|
12045614|NCT00239447|Device|Respimat SMI|
12045615|NCT00239434|Drug|tiotropium inhalation powder capsule|
12045616|NCT00239434|Drug|ipratropium bromide Metered Dose Inhaler|
12045617|NCT00239421|Drug|Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule)|
12045618|NCT00239421|Drug|Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d.|
12045619|NCT00239408|Device|Pulmonary function Testing|
12045620|NCT00239408|Drug|tiotropium bromide|
12045621|NCT00239395|Drug|Meloxicam ampoule|
12045622|NCT00239395|Drug|Meloxicam tablet|
12045623|NCT00239382|Drug|Meloxicam ampoule|
12045624|NCT00239382|Drug|Meloxicam tablet|
12045625|NCT00239369|Drug|Fixed dose combination telmisartan 80 mg + HCTZ 25 mg|
12045626|NCT00239369|Drug|Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg|
12045627|NCT00239356|Drug|Aripiprazole|Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country
12045628|NCT00239343|Drug|gefitinib|
12045629|NCT00239330|Drug|Rosuvastatin|
12045630|NCT00239330|Drug|Atorvastatin|
12045631|NCT00239317|Drug|Tamusulosin|
12045632|NCT00239304|Drug|Gefitinib|
12045633|NCT00239304|Drug|Cisplatin|
12045634|NCT00239304|Procedure|Radiotherapy|
12045635|NCT00239291|Drug|Gefitinib, radiotherapy|
12045636|NCT00239278|Drug|budesonide/formoterol, 2x 200/6 microgram. 4 times daily|
12045637|NCT00239278|Drug|prednisolone, 30 mg once daily and placebo|
12045638|NCT00239265|Drug|Tamuslosin|
12045639|NCT00239252|Drug|Interferon alfacon-1|
12045640|NCT00239239|Drug|Darbepoetin alfa|darbepoetin alfa SC dosing 0.45 mcg/kg 3 times per week through study day 40. Optional extended treatment period: 200 mcg Q2W through study day 110
12045641|NCT00239226|Procedure|IAS pacing - study group|site of implant and permanent pacing
12045642|NCT00239226|Procedure|IAS pacing control group|site of implant and permanent pacing
12045643|NCT00239226|Procedure|Pacing RAA study group|site of implant and permanent pacing
12045644|NCT00239226|Procedure|Pacing RAA control group|site of implant and permanent pacing
12045645|NCT00239213|Drug|catechin extracts (health food)|
12045646|NCT00239200|Drug|Lapatinib|
12045647|NCT00239187|Drug|E1 and G1|
12045648|NCT00239174|Drug|SR147778|
12045649|NCT00239161|Drug|Levofloxacin|
12045650|NCT00239148|Drug|E1 and G1|
12045651|NCT00239135|Drug|PEP005|
12045652|NCT00239122|Behavioral|Recovery Therapy (Cognitive Behaviour Therapy for psychosis)|
12045653|NCT00239109|Drug|Ziprasidone|
12045654|NCT00239109|Drug|Olanzapine|
12045655|NCT00239109|Procedure|Scales|
12045656|NCT00239109|Procedure|measures of the body (Weight...)|
12045657|NCT00239109|Procedure|Serum analysis|
12045658|NCT00239096|Drug|losartan (drug)|
12045659|NCT00239083|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045660|NCT00239070|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045661|NCT00239057|Drug|Enteric-Coated Mycophenolate Sodium|
12045662|NCT00239044|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12045663|NCT00239031|Drug|Enteric-Coated Mycophenolate Sodium|Enteric-Coated Mycophenolate Sodium
12045664|NCT00239018|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045665|NCT00239005|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045666|NCT00239005|Drug|Mycophenolate Mofetil (MMF)|
12045667|NCT00238992|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12045668|NCT00238979|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045669|NCT00238966|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045670|NCT00238953|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045671|NCT00238940|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12045672|NCT00238927|Drug|inhaled fluticasone 750 mcg/day twice daily until 2 days without symptoms (maximum 15 consecutive days)|
12045673|NCT00238914|Drug|Naltrexone|50mg of oral naltrexone daily
12045677|NCT00238888|Procedure|asthma control awareness|Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit
12045678|NCT00238888|Procedure|Usual care|Recommendation for asthma education and/or follow-up at the physician's discretion
12045679|NCT00238875|Procedure|stereotactic body radiation therapy|Procedure/Surgery: stereotactic body radiation therapy
12045680|NCT00238862|Procedure|Amniotic membrane transplantation|
12045681|NCT00238862|Drug|Autologous serum/BSS 20%|
12045682|NCT00238849|Drug|Oxaliplatin|
12045683|NCT00238836|Behavioral|Self-management of chronic illness|
12045684|NCT00238797|Drug|Gefitinib|
12045685|NCT00238784|Drug|Budesonide/formoterol Turbuhaler|
12045686|NCT00238758|Drug|Omega-3 Polyunsaturated Fatty Acids|
12045687|NCT00238745|Drug|Bazedoxifene|
12045688|NCT00238745|Drug|Placebo|
12045689|NCT00238732|Drug|Bazedoxifene/Conjugated Estrogen|
12045690|NCT00238719|Drug|Venlafaxine ER|
12045691|NCT00238706|Device|Radiofrequency ablation|
12045692|NCT00238680|Behavioral|Bladder rehabilitation|
12045693|NCT00238680|Behavioral|Bladder rehabilitation with programmable timer|
12045694|NCT00238667|Drug|Antiplatelet (Aspirin, Dipyridamole, clopidogrel)|
12045695|NCT00238667|Drug|Anticoagulant (Unfractionated Heparin, LMW Heparin, Warfarin)|
12045696|NCT00238641|Drug|Botulinum Toxin type B|
12045697|NCT00238628|Drug|Bexarotene|
12045698|NCT00238628|Drug|Iressa|
12045699|NCT00238615|Drug|Docetaxel|20 mg/m2, 75 mg/m2 infusion
12045700|NCT00238615|Drug|Carboplatin|AUC of 2 and 6 infusion
12045701|NCT00238615|Procedure|Radiation therapy|NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.
12045702|NCT00238615|Procedure|Surgical resection|All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.
12045703|NCT00238602|Procedure|Stereotactic radiosurgery|
12045704|NCT00238563|Drug|Triamcinolone injection, sub-tenon|
12045705|NCT00238550|Drug|Cannabis based medicine extract (CBME)|
12045706|NCT00238537|Drug|Alteplase t-PA|
12045707|NCT00238524|Drug|SPM 927|
12045708|NCT00238511|Drug|SPM 927|
12045709|NCT00238498|Drug|vildagliptin|
12045710|NCT00238485|Drug|Licarbazepine|
12045711|NCT00238472|Drug|nateglinide|
12045712|NCT00238459|Drug|Patients elected to take licensed drugs. The vaccine was not provided for evaluation|Note:In August 2007 we were notified by the manufacturer that the experimental vaccine was no longer being made and would no longer be available for this study. Too few participants have received the vaccine or placebo to conclude anything about potential efficacy
12045713|NCT00238459|Drug|multiple licensed drugs not randomized|
12045714|NCT00238459|Drug|multiple licensed antiretroviral drugs; not randomized|
12045715|NCT00238459|Other|Intended vaccine not provided, Licensed drugs provided, but were not investigated|
12045716|NCT00238446|Drug|EC-MPS|
12045717|NCT00238433|Biological|filgrastim|5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days.
12045718|NCT00238433|Drug|busulfan|3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
12045719|NCT00238433|Drug|melphalan|50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
12045720|NCT00238433|Drug|thiotepa|250 mg/m2/day/iv on days -3 and -2
12045721|NCT00238433|Procedure|bone marrow ablation with stem cell support|The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
12045722|NCT00238433|Procedure|peripheral blood stem cell transplantation|Performed 36-48 hours following last chemotherapy dose.
12045723|NCT00238420|Drug|Paclitaxel|Given IV
12045724|NCT00238420|Radiation|Radiation Therapy|Undergo radiation therapy
12045725|NCT00238420|Biological|Trastuzumab|Given IV
12045726|NCT00238407|Drug|Docetaxel and Cisplatin|Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.
12045727|NCT00238407|Radiation|Radiotherapy|Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
12045728|NCT00238394|Drug|cediranib maleate|Given orally
12045729|NCT00238394|Other|laboratory biomarker analysis|Correlative studies
12045730|NCT00238381|Procedure|5 cm colon-J-pouch|5 cm colon-J-pouch with/without temporary protective ileostomy
12045731|NCT00238381|Procedure|side-to-end anastomosis|side-to-end anastomosis with/without temporary protective ileostomy
12045732|NCT00238381|Procedure|straight coloanal anastomosis|straight coloanal anastomosis with/without temporary protective ileostomy
12045733|NCT00238368|Biological|filgrastim|
12045734|NCT00238368|Biological|rituximab|
12045735|NCT00238368|Drug|busulfan|
12045736|NCT00238368|Drug|cisplatin|
12045737|NCT00238368|Drug|cyclophosphamide|
12045738|NCT00238368|Drug|cytarabine|
12045739|NCT00238368|Drug|doxorubicin hydrochloride|
12045740|NCT00238368|Drug|etoposide|
12045741|NCT00238368|Drug|methylprednisolone|
12045742|NCT00238368|Drug|prednisone|
12045743|NCT00238368|Drug|vincristine sulfate|
12045744|NCT00238368|Procedure|autologous bone marrow transplantation|
12045745|NCT00238368|Procedure|peripheral blood stem cell transplantation|
12045746|NCT00238368|Procedure|positron emission tomography|
12045747|NCT00238368|Radiation|fludeoxyglucose F 18|
12045748|NCT00238368|Radiation|radiation therapy|
12045827|NCT00237822|Behavioral|AF + Contingency Management (AF + CM)|
12045749|NCT00238355|Drug|caspofungin acetate|70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.
12045750|NCT00238355|Drug|voriconazole|6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour before or after meals).
12045751|NCT00238342|Genetic|proteomic profiling|
12045752|NCT00238342|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
12045753|NCT00238342|Procedure|biopsy|
12045754|NCT00238329|Biological|PEG-interferon alfa-2b|
12045755|NCT00238329|Drug|thalidomide|
12045756|NCT00238316|Drug|letrozole|2.5 mg PO daily for 1 year
12045757|NCT00238316|Other|Placebo|2.5 mg PO daily for one 1 year
12045758|NCT00238303|Drug|vorinostat|Given orally
12045759|NCT00238303|Procedure|conventional surgery|Patients undergo surgery to remove tumor
12045760|NCT00238290|Drug|Trastuzumab + Letrozole|Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1-3 OR once in week 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression after 9 weeks receive trastuzumab as before and oral letrozole once daily in the absence of further disease progression or unacceptable toxicity.
12045761|NCT00238277|Drug|temozolomide|
12045762|NCT00238277|Procedure|adjuvant therapy|
12045763|NCT00238277|Procedure|chemotherapy|
12045764|NCT00238277|Procedure|radiation therapy|
12045765|NCT00238264|Radiation|radiation therapy|Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
12045766|NCT00238251|Drug|gefitinib|Once daily during days 1-28
12045767|NCT00238251|Drug|temozolomide|Once daily on days 1-21
12045768|NCT00238251|Radiation|radiation therapy|Whole brain radiotherapy
12045769|NCT00238238|Biological|rituximab|Given IV
12045770|NCT00238238|Drug|lenalidomide|Given orally
12045771|NCT00238225|Dietary Supplement|calcitriol|
12045772|NCT00238225|Drug|dexamethasone|
12045773|NCT00238225|Drug|ketoconazole|
12045774|NCT00238212|Drug|sorafenib tosylate|Given orally
12045775|NCT00238212|Other|laboratory biomarker analysis|Correlative studies
12045776|NCT00238199|Dietary Supplement|calcitriol|
12045777|NCT00238199|Drug|docetaxel|
12045778|NCT00238173|Biological|filgrastim|
12045779|NCT00238173|Drug|acetylcysteine|administered i.v. over 30 to 60 minutes
12045780|NCT00238173|Drug|carboplatin|(200 mg/m2/day; total dose 400 mg/m2) will be infused i.a. over 10 minutes, in 50-180 cc of normal saline.
12045781|NCT00238173|Drug|cyclophosphamide|(330 mg/m2/day; total dose 660 mg/m2) will be infused i.v. in 25-50 cc of normal saline, over approximately 10 minutes.
12045782|NCT00238173|Drug|etoposide phosphate|(200 mg/m2/day; total dose 400 mg/m2) will be infused i.v. in 25-100 cc of normal saline, over approximately 10 minutes, immediately following the cyclophosphamide.
12045783|NCT00238173|Drug|mannitol|(25%) delivered i.a. at a pre-determined flow rate over 30 seconds. The flow rate will be determined by iodinated contrast injection and fluoroscopy as the lowest infusion rate in which there is retrograde flow from the arterial catheter. The rate and volume of mannitol infused will be approximately 4-12 cc/sec x 30 seconds.
12045784|NCT00238173|Drug|sodium thiosulfate|STS is available as a 25% (250 mg/ml) solution. The dose of STS administered 4 hours after carboplatin is 16 gm/m2. The dose of STS administered 8 hours after carboplatin is 16 gm/m2. Actual dose to be administered will be determined and mixed with an equivalent amount of sterile water (1 ml:1 ml) for infusion.
12045785|NCT00238160|Drug|cisplatin|
12045786|NCT00238160|Drug|fluorouracil|
12045787|NCT00238160|Procedure|adjuvant therapy|
12045788|NCT00238160|Procedure|chemotherapy|
12045789|NCT00238160|Procedure|conventional surgery|
12045790|NCT00238160|Procedure|hepatic arterial infusion|
12045791|NCT00238160|Procedure|surgery|
12045792|NCT00238147|Drug|capecitabine|
12045793|NCT00238147|Drug|carboplatin|
12045794|NCT00238147|Drug|docetaxel|
12045795|NCT00238147|Procedure|conventional surgery|
12045796|NCT00238147|Procedure|neoadjuvant therapy|
12045797|NCT00238147|Radiation|radiation therapy|
12045798|NCT00238121|Drug|sorafenib tosylate|Given orally
12045799|NCT00238108|Drug|Melatonin|2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
12045800|NCT00238108|Drug|Placebo|Placebo
12045801|NCT00238082|Drug|HFA-134A Beclomethasone DIpropionate (QVAR)|
12045802|NCT00238069|Device|CPAP machine as a result of sleep study|
12045803|NCT00238056|Drug|domperidone Drug|
12045804|NCT00238043|Drug|Biogeneric Epoetin|
12045805|NCT00238030|Drug|L-thryoxine|2 mcg/kg iv or 2 mcg/kg po at time of enrollment
12045806|NCT00238030|Drug|iv thryoxine|thyroxine 2 mcg/kg iv
12045807|NCT00238017|Drug|amodiaquine-artesunate versus amodiaquine|
12045808|NCT00238004|Drug|Nicotinic acid|
12045809|NCT00237991|Biological|Hepatitis A|
12045810|NCT00237978|Drug|Adapalen|
12045811|NCT00237978|Radiation|VIS and wIRA|
12045812|NCT00237965|Behavioral|Mole Mapping Diagram|
12045813|NCT00237952|Drug|EDTA chelating agents|
12045814|NCT00237939|Drug|Aripiprazole|
12045815|NCT00237926|Behavioral|Exercise|aerobic or resistance training
12045816|NCT00237913|Drug|Aripiprazole|Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.
12045817|NCT00237913|Drug|Olanzapine or Quetiapine or Risperidone|Olanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks.
12045818|NCT00237900|Drug|Gefitinib, 5-fluorouracil, leucovorin and radiotherapy|
12045819|NCT00237887|Drug|adalimumab|
12045820|NCT00237874|Drug|Aripiprazole|
12045821|NCT00237861|Drug|risperidone|
12045822|NCT00237861|Drug|olanzapine|
12045823|NCT00237861|Drug|quetiapine|
12045824|NCT00237848|Drug|D-serine|
12045825|NCT00237848|Behavioral|Cognitive retraining|
12045826|NCT00237822|Behavioral|Adherence Feedback (AF)|
12045828|NCT00237822|Behavioral|AF + Motivational Enhancement Therapy (AF + MET)|
12045829|NCT00237809|Drug|D-serine|D-serine (30 mg/kg)
12045830|NCT00237809|Behavioral|Cognitive Retraining (CRT)|Cognitive retraining therapy (CRT)
12045831|NCT00237809|Drug|Placebo|Placebo D-serine Drug
12045832|NCT00237809|Behavioral|Cognitive Retraining Placebo|Cognitive retraining therapy (CRT) control
12045833|NCT00237796|Behavioral|Cognitive Behavioral Social Skills Training (CBSST)|Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
12045834|NCT00237796|Behavioral|Goal Focused Supportive Contact (GFSC)|Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
12045835|NCT00237783|Drug|dialysate sodium (140 mmol/L)|
12045836|NCT00237783|Drug|individualized dialysate sodium|individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)
12045837|NCT00237770|Drug|N-Nitro L-arginine-methylester (L-NAME)|A non-specific inhibitor of the nitric oxide synthase enzyme.
12045838|NCT00237770|Procedure|Head-up Tilt maneuver|Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.
12045839|NCT00237757|Behavioral|Information feedback|The experimental arm consisted of a six month staff training period. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing. The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes.
12045840|NCT00237757|Behavioral|Information feedback|The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative.
12045841|NCT00237744|Device|Robotics training for shoulder elbow.|training utilizing a robot to assist with movement practice
12045842|NCT00237744|Device|Surface Functional Neuromuscular Stimulation|training utilizing FNS to assist with movement practice
12045843|NCT00237744|Other|whole arm motor learning|intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
12045844|NCT00237731|Drug|morphine|morphine 0.05
12045845|NCT00237731|Drug|morphine|morphine 0.10
12045846|NCT00237718|Drug|Alpha, gamma, beta, and delta (mixed) tocopherols|approximately 666 IU daily (1 pill) for 6 months
12045847|NCT00237718|Drug|Alpha lipoic acid|600 mg daily (2 pills 300 mg each) for 6 months
12045848|NCT00237718|Drug|Placebo|placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months
12045849|NCT00237718|Drug|Placebo|placebo for alpha lipoic acid; 2 pills daily for 6 months
12045850|NCT00237705|Drug|metoclopramide|
12045851|NCT00237692|Behavioral|Nurse Behavioral intervention with Home BP Telemonitoring|Nurse-administered behavior intervention
12045852|NCT00237692|Behavioral|Nurse Medication Management with Home BP Telemonitoring|Nurse administer medication management according to hypertension decision support
12045853|NCT00237692|Behavioral|Nurse Combined intervention with Home BP Telemonitoring|Combination of the nurse administered tailored behavioral & medication management
12045854|NCT00237679|Behavioral|Neuromuscular Electrical Stimulation|Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
12045855|NCT00237679|Behavioral|Unstimulated|No current is generated.
12045856|NCT00237666|Drug|Ziprasidone|Ziprasidone 20-60 mg BID, taken orally.
12045857|NCT00237653|Drug|Valganciclovir|
12045858|NCT00237640|Drug|Cinnamon or placebo 500 mg capsule twice daily|Cinnamon 500 mg capsule twice daily or placebo capsule twice daily
12045859|NCT00237627|Drug|PS-341|PS-341 will be administered as an intravenous push into a side arm of either a peripheral or central intravenous line infusing normal saline at 100 ml/hr. Patients will be treated twice weekly for two weeks, followed by a one week rest period, such that the typical days of treatment will be days 1, 4, 8, 11 of each three-week cycle. The initial dose level for PS-341 will be 0.9 mg/m2/dose intravenously, while subsequent dose levels will be determined according to a modified Fibonacci schema
12045860|NCT00237627|Drug|Doxil|Doxil will be administered at a dose of 30 mg/m2 as a 1 hour infusion through either a peripheral or central intravenous line every 3 weeks (on day 4 of each 21 day cycle)
12045861|NCT00237627|Drug|Velcade|Velcade will be adminstered intravenously at 1.3 mg/m2 days 1, 4, 8, 11 every 3 weeks
12045862|NCT00237614|Drug|intravenous and oral N-acetylcysteine|
12045863|NCT00237601|Other|obstetric care|
12045864|NCT00237588|Drug|Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg|
12045865|NCT00237575|Drug|gemcitabine|
12045866|NCT00237575|Drug|cisplatin|
12045867|NCT00237575|Drug|sargramostim|
12045868|NCT00237575|Drug|filgrastim|
12045869|NCT00237562|Procedure|Large loop electrosurgical excision|
12045870|NCT00237549|Procedure|optimised treatment|"The intervention targeted individual patients and the Primary Care Team. Practitioners were trained in a target driven, intensive multifactorial approach including lifestyle advice (smoking cessation, physical activity 30 min./day and healthy diet) and pharmacological treatment with the aim of reducing the complications of diabetes as described in protocol.
~The training included meetings, practice visiting, written feed back reports and reminders on controls."
12045871|NCT00237536|Drug|Lonidamine|
12045872|NCT00237523|Drug|IoGen (molecular iodine)|
12045874|NCT00237497|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.
12045875|NCT00237497|Drug|Zopiclone|Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights.
12045876|NCT00237497|Drug|Placebo|Placebo-matching tablets, orally, once daily for up to 28 nights.
12045877|NCT00237484|Drug|Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin|"Powder for intravenous infusion (100 mg strength), intravenous, single dose of 5 mg/kg, at Day -7, prior to initiation of the following combination therapy:
~powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
~200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks"
12045878|NCT00237484|Drug|Combination of (a) pegylated interferon alfa-2b and (b) ribavirin|"Powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
~200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks"
12045879|NCT00237471|Drug|Insulin (tight blood glucose control)|
12045880|NCT00237458|Drug|Lacosamide|"Dosage: Lacosamide up to 400 mg/day;
~Dosage form: Film-coated tablets;
~Dosage Frequency and Duration: Two times per day; 9.5 years"
12045881|NCT00237445|Drug|telithromycin|
12045882|NCT00237445|Drug|azithromycin|
12045883|NCT00237419|Drug|infliximab|Infliximab infusions 5 mg/kg body-weight each 6 to 8 weeks
12045884|NCT00237406|Procedure|interactive voice response|
12045885|NCT00237393|Drug|Quetiapine|Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
12045886|NCT00237393|Drug|Placebo|Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
12045887|NCT00237380|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water.
12045888|NCT00237367|Drug|rabeprazole and pantoprazole|
12045889|NCT00237354|Drug|PV-10 (rose bengal disodium 10%)|PV-10 ablation of study lesion
12045890|NCT00237341|Drug|fentanyl|
12045891|NCT00237328|Drug|Heparin|Heparin will be used as the intra-operative anticoagulant
12045892|NCT00237302|Drug|topiramate|
12045893|NCT00237289|Drug|topiramate|
12045894|NCT00237276|Procedure|colonoscopy|
12045895|NCT00237263|Drug|Entacapone|
12045896|NCT00237250|Drug|vildagliptin|
12045897|NCT00237237|Drug|vildagliptin|
12045898|NCT00237224|Drug|Letrozole|
12045899|NCT00237211|Drug|Letrozole|
12045900|NCT00237198|Drug|Letrozole|
12045901|NCT00237185|Drug|Imatinib mesylate|Participants were randomized 1:1 to receive imatinib mesylate 400 mg/day or 600 mg/day. Upon unsatisfactory treatment effect on the starting dose of 400 mg/day or 600 mg/day imatinib mesylate, in the opinion of the treating physician, a dose increase up to 600 mg/day or 800 mg/day, was allowed provided that the participant continued to benefit from the treatment and in the absence of safety concerns.
12045902|NCT00237172|Drug|Imatinib Mesylate|once daily
12045903|NCT00237159|Drug|Zoledronic acid|
12045904|NCT00237146|Drug|Zoledronic acid|
12045905|NCT00237133|Drug|Letrozole|1 tablet of Letrozole 2.5 mg orally adminnistered once a day
12045906|NCT00237120|Drug|Imatinib|
12045907|NCT00237107|Procedure|Curretage|
12045908|NCT00237094|Behavioral|Nurse Practitioner led multidisciplinary team approach|
12045909|NCT00237068|Drug|Lansoprazole; Solutab|15 and 30 mg doses of dissolvable tablet, 2 tablets daily for one year
12045910|NCT00237042|Behavioral|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
12045911|NCT00237042|Behavioral|Targeted Self Management|Self management as described above. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
12045912|NCT00237042|Drug|20 mcg ethinyl estradiol and 100 mcg levonorgestrel|Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
12045913|NCT00237016|Drug|doxycycline treatment|
12045914|NCT00237003|Behavioral|motivational interviewing|Assessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation.
12045915|NCT00236990|Drug|pentosan polysulfate sodium|
12045916|NCT00236977|Drug|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
12045917|NCT00236977|Drug|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
12045918|NCT00236964|Drug|Iron Sucrose + Erythropoietin|
12045919|NCT00236964|Drug|Ferrous Sulfate + Erythropoietin|
12045920|NCT00236951|Drug|iron sucrose injection USP|
12045921|NCT00236951|Drug|stable erythropoietin therapy|
12045922|NCT00236938|Drug|Venofer and stable erythropoietin (EPO) regimen|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
12045923|NCT00236938|Drug|stable erythropoietin (EPO) regimen|Stable erythropoietin (EPO) dose and no supplemental iron.
12045924|NCT00236925|Drug|Low dose Hydrocortisone|Hydrocortisone 10 mg daily
12045925|NCT00236925|Drug|Placebo|Placebo
12045926|NCT00236912|Drug|levofloxacin; metronidazole|
12045927|NCT00236899|Drug|Gemcitabine|"Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
~Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
12045928|NCT00236899|Drug|Docetaxel|"Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
12045929|NCT00236899|Drug|Paclitaxel|"Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
12045930|NCT00236886|Drug|topiramate|
12045931|NCT00236873|Drug|topiramate|
12045932|NCT00236860|Drug|topiramate|
12045933|NCT00236847|Drug|topiramate|
12045934|NCT00236834|Drug|levofloxacin; imipenem/cilastitin|
12045935|NCT00236821|Drug|levofloxacin|
12045936|NCT00236808|Drug|levofloxacin|
12045937|NCT00236795|Drug|norelgestromin + ethinyl estradiol; triphasil.|
12045938|NCT00236782|Drug|norelgestromin + ethinyl estradiol; mercilon|
12045939|NCT00236769|Drug|norelgestromin + ethinyl estradiol|
12045940|NCT00236756|Drug|topiramate|
12045941|NCT00236743|Drug|topiramate|
12045942|NCT00236730|Drug|topiramate|
12045943|NCT00236717|Drug|Topiramate; Carbamazepine; Valproate|
12045944|NCT00236704|Drug|topiramate|
12045945|NCT00236691|Drug|topiramate|
12045946|NCT00236678|Drug|Epoetin alfa|
12045947|NCT00236665|Drug|topiramate|
12045948|NCT00236652|Drug|levofloxacin|
12045949|NCT00236639|Drug|topiramate|
12045950|NCT00236626|Drug|topiramate|
12045951|NCT00236613|Drug|topiramate|
12045952|NCT00236600|Drug|topiramate|
12045953|NCT00236587|Drug|risperidone|
12045954|NCT00236574|Drug|Galantamine hydrobromide|
12045955|NCT00236561|Drug|topiramate, propranolol|
12045956|NCT00236548|Drug|risperidone|
12045957|NCT00236535|Drug|tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo|
12045958|NCT00236522|Drug|levofloxacin|
12045959|NCT00236509|Drug|topiramate|
12045960|NCT00236496|Drug|topiramate|
12045961|NCT00236483|Drug|tramadol hydrochloride + acetaminophen|
12045962|NCT00236470|Drug|risperidone|
12045963|NCT00236457|Drug|risperidone|
12045964|NCT00236444|Drug|risperidone|
12045965|NCT00236431|Drug|Galantamine hydrobromide|
12045966|NCT00236418|Drug|topiramate|
12045967|NCT00236405|Drug|epoetin alfa|
12045968|NCT00236392|Drug|rabeprazole|
12045969|NCT00236379|Drug|Olanzapine|Target oral dose of 20 milligrams per day for 6 months
12045970|NCT00236379|Drug|Risperidone|Target oral dose of 6 milligrams per day for for 6 months
12045971|NCT00236366|Drug|fentanyl|
12045972|NCT00236353|Drug|risperidone|
12045973|NCT00236340|Device|syringe aspiration|
12045974|NCT00236340|Device|Wall suction|
12045975|NCT00236327|Drug|fentanyl|
12045976|NCT00236301|Drug|CLIMASTON (drug)|CLIMASTON(drug)
12045977|NCT00236301|Drug|17 Beta-estradiol (2mg/day)and (1mg/day)|17 Beta-estradiol (2mg/day)and (1mg/day)
12045978|NCT00236301|Drug|placebo|placebo
12045979|NCT00236288|Drug|Bupropion and intensive behavioral therapy|To prescribe bupropion and behavioral therapy to patients and/or their families, who are currently receiving radiation.
12045980|NCT00236275|Drug|Fluoro-L-thymidine-(18F)|Fluoro-L-thymidine-(18F)
12045981|NCT00236262|Device|ventilatory strategies with pressure|
12045982|NCT00236249|Drug|Lidocaine|
12045983|NCT00236236|Device|Cardiac Resynchronization Therapy|
12045984|NCT00236223|Drug|Gabapentin + dexamethasone + ketamine|Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
12045985|NCT00236223|Drug|Placebo|Matching placebo
12045986|NCT00236210|Behavioral|Action Score|Improvement in a novel 100-point score summarizing cardiovascular risk.
12045987|NCT00236210|Behavioral|VIP program|Risk assessment, lifestyle counselling, exercise program
12045988|NCT00236197|Drug|rabeprazole sodium|Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
12045989|NCT00236197|Drug|placebo|Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
12045990|NCT00236184|Drug|rabeprazole sodium|Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
12045991|NCT00236184|Other|Placebo|Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
12045992|NCT00236171|Drug|Protopic, Advantan|
12045993|NCT00236171|Procedure|Blood and Urine Test|
12045994|NCT00236171|Procedure|coherence tomography|
12045995|NCT00236158|Device|AAIR/DDDR pacemaker|Pacemaker with single lead or dual lead
12045996|NCT00236145|Drug|ACTIQ (Oral transmucosal fentanyl citrate)|
12045997|NCT00236119|Drug|CEP-701 20mg|Dosages of oral CEP-701 20mg will be given twice daily. Escalation to the next higher dosage, CEP-701 40mg, may occur once the first 8 patients at the current dosage have completed 8 weeks of treatment without adverse events or laboratory abnormalities. Patients who remain in Cohort 1 will continue on the 20mg dosage until study completion.
12045998|NCT00236119|Drug|CEP-701 40mg|Dosages of oral CEP-701 40mg will be given twice daily.Escalation to the next higher dosage, CEP-701 60mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 2 will continue on the 40mg dosage until study completion.
12045999|NCT00236119|Drug|CEP-701 60mg|Dosages of oral CEP-701 60mg will be given twice daily. Escalation to the next higher dosage, CEP-701 80mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 3 will continue on the 60mg dosage until study completion.
12046000|NCT00236119|Drug|CEP-701 80mg|Dosages of oral CEP-701 80mg will be given twice daily. Patients who have moved to Cohort 4 will continue on the 80mg dosage until study completion.
12046001|NCT00236106|Drug|tacrolimus ointment 0.1%|
12046002|NCT00236106|Drug|mometasone furoate 0.1%|
12046003|NCT00236093|Drug|ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])|
12046004|NCT00236080|Drug|PROVIGIL 200 mg|PROVIGIL 200 mg/day
12046005|NCT00236080|Drug|Armodafinil 250 mg|Armodafinil 250 mg/day
12046006|NCT00236080|Drug|Armodafinil 200 mg|Armodafinil 200 mg/day
12046007|NCT00236080|Drug|Armodafinil 150 mg|Armodafinil 150 mg/day
12046008|NCT00236080|Drug|Placebo|Matching placebo tablets
12046009|NCT00236067|Drug|Gabitril|
12046010|NCT00236054|Drug|Gabitril|
12046011|NCT00236041|Drug|ACTIQ®|
12046012|NCT00236028|Drug|Infliximab|
12046013|NCT00236015|Drug|Gabitril|
12046014|NCT00236002|Drug|Alendronate|Alendronate 70mgm once a week for one year
12046015|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|250 mcg administered s.c.(subcutaneous) every other day
12046016|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|250 mcg administered s.c. every other day (for patients having received 500 mcg before)
12046017|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|500 mcg administered s.c. every other day
12046018|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|500 mcg administered s.c. every other day (for patients having received 250 mcg before)
12046019|NCT00235976|Drug|Gantacurium Chloride for Injection (AV430A)|
12046020|NCT00235963|Drug|Simvastatin|
12046021|NCT00235950|Drug|Rosuvastatin or atorvastatin or simvastatin and clopidogrel|
12046022|NCT00235937|Drug|Anastrozole and goserelin|
12046023|NCT00235924|Drug|soy isoflavone|
12046024|NCT00235911|Drug|budesonide/formoterol Turbuhaler|
12046025|NCT00235898|Drug|CoFactor|
12046026|NCT00235898|Drug|5-FU|
12046027|NCT00235898|Drug|Leucovorin|
12046028|NCT00235885|Drug|adalimumab|
12046029|NCT00235872|Biological|adalimumab|40 mg eow, sc
12046030|NCT00235859|Drug|adalimumab|
12046031|NCT00235859|Drug|methotrexate|
12046032|NCT00235846|Procedure|vein harvest|Conventional open vein harvest or endoscopic vein harvest
12046033|NCT00235833|Biological|adalimumab|40 mg every other week (eow), subcutaneous (sc)
12046034|NCT00235820|Drug|adalimumab|40 mg every other week following an 80 mg dose
12046035|NCT00235820|Drug|MTX|MTX 7.5 to 25 mg once weekly
12046036|NCT00235820|Drug|placebo adalimumab, placebo MTX|placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
12046037|NCT00235807|Procedure|Tinnitus Masking|Sound therapy with Tinnitus Masking is intended to produce immediate relief from the discomfort caused by tinnitus (Vernon, 1977; 1987; Vernon, 1988). If maskers or combination units are used, the masking sound can be set at any level the patient chooses to attain maximum relief. Relief using masking noise can be accomplished using the external sound of the masker, which is generally a more acceptable sound than the tinnitus.
12046038|NCT00235807|Procedure|Tinnitus Retraining Therapy (TRT)|The TRT procedure adheres as closely as possible to the methodology described by Dr. Pawel Jastreboff. For TRT, sound therapy is used to facilitate long-term habituation to tinnitus (Jastreboff, 1999b).
12046039|NCT00235807|Procedure|Tinnitus Education (TED)|TED represents tinnitus treatment that would typically be provided by audiologists using hearing aids and counseling (although for this study the counseling has been structured and expanded to be equivalent in length to the other two groups).
12046040|NCT00235794|Drug|temsirolimus|
12046041|NCT00235781|Drug|Thymoglobulin|
12046042|NCT00235755|Drug|Retigabine|Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.
12046043|NCT00235755|Drug|Retigabine|Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.
12046044|NCT00235755|Drug|Placebo|Oral tablet.
12046045|NCT00235729|Drug|Lofexidine|Lofexidine is an alpha2-adrenergic-agonist with mild to moderate antihypertensive actions. It is mainly used in the alleviation of opioid withdrawal signs and symptoms.
12046046|NCT00235729|Drug|Placebo|Placebo is an exact match of lofexidine, less the active ingredient.
12046047|NCT00235716|Drug|dl-alpha-tocopherol|"Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate (synthetic) vitamin E."
12046098|NCT00235235|Procedure|Serum Collection|serum collection
12046099|NCT00235235|Procedure|Urine Collection|urine collection
12046100|NCT00235235|Drug|Doxorubicin|Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
12046101|NCT00235235|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
12046048|NCT00235716|Drug|Memantine|A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.
12046049|NCT00235716|Drug|dl-alpha-tocopherol|"Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate (synthetic) vitamin E."
12046050|NCT00235716|Drug|Memantine|A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.
12046051|NCT00235716|Drug|Placebo|Matching placebos for dl-alpha-tocopherol and memantine.
12046052|NCT00235703|Device|Antimicrobial Prescribing Decision Support|
12046053|NCT00235690|Procedure|Blood draws|PK samples obtained around a clinical dosing of colistin
12046054|NCT00235690|Other|Blood draw|PK blood samples will be obtained around a clinical dosing of colistin
12046055|NCT00235677|Procedure|Endoscopic gastroplication|
12046056|NCT00235664|Procedure|Collection of stool and endotracheal aspirate samples|collection of samples
12046057|NCT00235651|Drug|Amphotericin B|
12046058|NCT00235625|Drug|Curcuminoids C3 Complex®|
12046059|NCT00235599|Procedure|IGFBP-3 Stimulation Test|
12046060|NCT00235586|Procedure|10 vit. D deficient subjects take vit. D for 3 months.|
12046061|NCT00235573|Dietary Supplement|Vitamin B12|After taking a fasting blood sample, all subjects were given a light breakfast plus 9 micrograms of vitamin B12. Two more doses of vitamin B12, 9 micrograms each, were administered 6 hours apart.
12046062|NCT00235560|Drug|rapamycin|sirolimus
12046063|NCT00235547|Behavioral|timing of initiation of transdermal patch after an abortion|the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic
12046064|NCT00235534|Behavioral|Immediate initiation of OCPs|
12046065|NCT00235534|Behavioral|Delayed initiation of OCPs|
12046066|NCT00235521|Drug|aerosolized iloprost|
12046067|NCT00235508|Drug|Eszopiclone (Lunesta)|Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
12046068|NCT00235495|Biological|Albumin|human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset
12046069|NCT00235495|Drug|Saline|equivalent volume of isotonic saline control
12046070|NCT00235482|Drug|Coxsackievirus A21|
12046071|NCT00235469|Drug|SPM 927|
12046072|NCT00235456|Procedure|Perioperative supplemental oxygen|Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
12046073|NCT00235456|Procedure|Standard oxygen|Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
12046074|NCT00235443|Drug|lacosamide|Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
12046075|NCT00235417|Procedure|Bone marrow transplantation|
12046076|NCT00235404|Other|Multicomponent treatment|Specialized care in preparing recharge to home
12046077|NCT00235404|Other|usual care|Usual recharge directly from hospital to home
12046078|NCT00235391|Drug|Deferasirox|125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day.
12046079|NCT00235365|Behavioral|meta-cognitive therapy|Meta-cognitive therapy
12046080|NCT00235365|Other|waiting list|waiting list control
12046081|NCT00235352|Drug|CX516 (Ampakine)|
12046082|NCT00235339|Behavioral|Exercise training|Standard exercise training at the hospital, two times per week for twelve weeks
12046083|NCT00235339|Behavioral|Exercise training|Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks
12046084|NCT00235313|Procedure|Dose adjustment of nicotine replacement therapies|Dose adjustment of nicotine replacement therapies
12046085|NCT00235313|Drug|nicotine patch|normal following with a nicotine patch
12046086|NCT00235300|Biological|Thymoglobulin [Anti-thymocyte Globulin (rabbit)]|1.5 mg/kg per day, for a maximum of 5 doses
12046087|NCT00235300|Drug|Simulect (basliximab)|20 mg per day on 2 days
12046088|NCT00235287|Drug|Candesartan and enalapril|24 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), where Enalapril is added in incremental doses (5,10 and 20 mg)the last 8 weeks.
12046089|NCT00235287|Drug|candesartan and enalapril|24 weeks of treatment with Enalapril in incremental doses (5, 10, 20 mg), where Candesartan is added in incremental doses (4,8,16 mg) in the last 8 weeks.
12046090|NCT00235287|Drug|candesartan and enalapril|8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), followed by 8 weeks of treatment with Enalapril in incremental doses (/5,10,20 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan in incremental doses (4,8,16 mg) and Enalapril 20 mg.
12046091|NCT00235287|Drug|candesartan and enalapril|8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg), followed by 8 weeks of treatment with Candesartan (4,8,16 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg)
12046092|NCT00235274|Drug|Subcutaneous Secretin|
12046093|NCT00235261|Drug|Pregabalin|
12046094|NCT00235261|Drug|Dexamethasone|
12046095|NCT00235248|Drug|Warfarin|Warfarin
12046096|NCT00235248|Drug|Clopidogrel-aspirin|Clopidogrel-aspirin
12046097|NCT00235235|Procedure|Biopsy|core biopsy
12046102|NCT00235235|Drug|Capecitabine|Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
12046103|NCT00235235|Drug|Vinorelbine|Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
12046104|NCT00235235|Drug|Gemcitabine|Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
12046105|NCT00235222|Drug|stavudine|
12046106|NCT00235209|Device|Collagen ORC Antimicrobial Matrix (CAM)|
12046107|NCT00235196|Device|Collagen ORC Antimicrobial Matrix (CAM)|
12046108|NCT00235183|Other|plasma|transfusion of more than 15 mL/Kg of plasma
12046109|NCT00235170|Device|drug-eluting stent|Cypher Sirolimus-eluting Coronary stent
12046110|NCT00235157|Device|Sirolimus-eluting Palmaz Genesis peripheral stent|treatment of renal artery stenosis with a renal stent
12046111|NCT00235144|Device|sirolimus-coated Bx Velocity stent|drug-eluting stent
12046112|NCT00235144|Device|uncoated Bx Velocity stent|bare-metal stent
12046113|NCT00235131|Device|Smart Stent|Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
12046114|NCT00235131|Device|Luminexx Stent|Bard® Luminexx™ 6F Vascular Stent
12046115|NCT00235118|Device|Cordis AAA Bilateral Device|
12046116|NCT00235105|Drug|Adalimumab 40 mg sc every other week|
12046117|NCT00235092|Device|Cypher Sirolimus-Eluting Stent|
12046118|NCT00235092|Device|Taxus Paclitaxel-Eluting Stent|
12046119|NCT00235079|Drug|Colchicine|Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
12046120|NCT00235079|Drug|Placebo|Placebo comparator
12046121|NCT00235066|Device|PCI|PCI with Cypher Sirolimus-Eluting Stent
12046122|NCT00235053|Drug|fluticasone/salmeterol DISKUS 250/50|
12046123|NCT00235040|Behavioral|Smart Form|Computer Decision Support System
12046124|NCT00235027|Other|Adverse Drug Event Monitoring|The intervention in this study is the presentation of medication safety alerts in the electronic medical record to improve patient outcomes and safety.
12046125|NCT00235014|Drug|trandolapril|2 mg QD
12046126|NCT00235014|Drug|trandolapril/verapamil|180/2 mg QD
12046127|NCT00235014|Drug|placebo|1 tablet QD
12046128|NCT00235014|Drug|verapamil|SR 240 mg QD
12046129|NCT00235001|Drug|trandolapril/verapamil|180/2 mg QD
12046130|NCT00234988|Drug|sibutramine hydochloride monohydrate|10 mg QD with the option to increase dose to 15 mg QD up until Week 4
12046131|NCT00234975|Drug|Lopinavir/Ritonavir|400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator
12046132|NCT00234962|Drug|Lopinavir/Ritonavir|
12046133|NCT00234949|Drug|cefdinir|
12046134|NCT00234949|Drug|cephalexin|
12046135|NCT00234936|Drug|Adalimumab|
12046136|NCT00234936|Drug|Methotrexate|
12046137|NCT00234923|Drug|lopinavir/ritonavir|400 mg lopinavir/ 100 mg ritonavir, BID
12046138|NCT00234923|Drug|lamivudine/zidovudine|300mg lamivudine/150mg zidovudine, BID
12046139|NCT00234910|Drug|Tenofovir DF|TDF 300mg QD for 72 wks
12046140|NCT00234910|Drug|lopinavir/ritonavir with 2 Nucleoside RTIs|LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
12046141|NCT00234897|Drug|adalimumab|
12046142|NCT00234884|Biological|adalimumab|commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)
12046143|NCT00234871|Drug|trandolapril/verapamil|2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
12046144|NCT00234871|Drug|Lotrel (amlodipine/benazepril)|5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD
12046145|NCT00234858|Drug|trandolapril/verapamil|2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
12046146|NCT00234858|Drug|(Hyzaar) losartan/hydrochlorothiazide|50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD
12046147|NCT00234845|Drug|adalimumab|
12046148|NCT00234845|Drug|methotrexate|
12046149|NCT00234832|Drug|Sibutramine hydrochloride|One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
12046150|NCT00234832|Drug|Placebo|1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
12046151|NCT00234832|Drug|Sibutramine hydrochloride|10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management
12046152|NCT00234819|Drug|Bazedoxifene/Conjugated Estrogen|
12046153|NCT00234806|Other|Health-e-Access|telemedicine intervention
12046154|NCT00234793|Behavioral|Problem-Solving Skills Training|
12046155|NCT00234780|Procedure|pediatric nursing used in home to avoid hospitalization|
12046156|NCT00234767|Device|Pulmonary Artery Catheter|
12046157|NCT00234767|Behavioral|Protocolized Fluid Management|
12046158|NCT00234754|Procedure|TVT Surgery TOT Surgery|TVT surgery and TOT surgery
12046159|NCT00234741|Drug|STA-5326 mesylate|
12046160|NCT00234728|Device|Occlusive dressing|
12046161|NCT00234702|Drug|Lanthanum carbonate|Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period.
12046162|NCT00234702|Drug|Placebo|Placebo
12046163|NCT00234689|Drug|Naltrexone|
12046164|NCT00234676|Drug|Premarin ®|Premarin ® 0.625 mg per day orally
12046165|NCT00234663|Drug|PTC124|
12046166|NCT00234650|Procedure|Colonoscopy|
12046167|NCT00234637|Drug|Rivastigmine, memantine|
12046168|NCT00234611|Procedure|Echocardiogram guided left ventricular lead placement|
12046169|NCT00234598|Procedure|Toothbrushing only|Toothbrushing three times per 24 hours without chlorhexidine
12046170|NCT00234598|Procedure|Chlorhexidine only|Chlorhexidine oral rinse twice per 24 hours without toothbrushing
12046171|NCT00234598|Procedure|Toothbrushing and Chlorhexidine|Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours.
12046172|NCT00234585|Device|Renal Artery Stent with Protective Device/Drug|
12046173|NCT00234572|Drug|Lanreotide (Autogel formulation)|
12046174|NCT00234559|Device|VAC® Therapy System|
12046175|NCT00234546|Biological|Botulinum toxin type A|1 injection, 500 U at day 0. The study will last for 6 months in each patient.
12046176|NCT00234546|Drug|Placebo|1 injection at day 0. The study will last for 6 months in each patient.
12046177|NCT00234533|Drug|Somatropin (rDNA origin)|Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
12046178|NCT00234507|Biological|Botulinum toxin type A|
12046179|NCT00234494|Drug|Cisplatin|Cisplatin 70 mg/m2, day 1
12046180|NCT00234494|Drug|Gemcitabine|Gemcitabine 1250 mg/m2, day 1 and 8
12046181|NCT00234494|Drug|Bevacizumab|Bevacizumab 15mg/kg, day 1
12046182|NCT00234481|Drug|XL844|
12046183|NCT00234468|Drug|Iressa (Gefitinib)|
12046184|NCT00234455|Device|drug eluting-stent|PCI
12046185|NCT00234455|Device|drug-eluting stent|PCI
12046186|NCT00234442|Drug|Iressa (Gefitinib)|
12046187|NCT00234429|Drug|Gefitinib, raltitrexed|
12046188|NCT00234416|Drug|Gefitinib|
12046189|NCT00234416|Drug|Gemcitabine|
12046190|NCT00234403|Drug|gefitinib and fulvestrant|
12046191|NCT00234390|Drug|Pulmicort (budesonide) pMDI|
12046192|NCT00234377|Drug|Seroquel SR|
12046193|NCT00234312|Drug|escitalopram and sertraline|
12046194|NCT00234299|Drug|Aspirin|325mg, one tablet orally, six months
12046195|NCT00234299|Drug|Placebo|325mg, one tablet orally every day, 6 months
12046196|NCT00234286|Behavioral|Comfort care education intervention|Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
12046197|NCT00234273|Procedure|Rehabilitation programme in Adapted Physical Activity (APA)|
12046198|NCT00234273|Behavioral|Therapeutic education primarily focused on dietary|
12046199|NCT00234247|Other|Long Term Follow-Up|Extended and enhance the follow-up of the NHLBI iNO RCT by assessing the effects of iNO use on: 1.) long term clinical and childhood developmental outcomes; 2.) family impact, and; 3.) healthcare costs of prematurity-associated respiratory failure.
12046200|NCT00234234|Drug|Adalimumab|
12046201|NCT00234221|Behavioral|Strengths Based Case Management|
12046202|NCT00234221|Behavioral|Motivational Enhancement Therapy|
12046203|NCT00234221|Behavioral|Brief Informational Feedback|
12046204|NCT00234208|Procedure|Medical thoracoscopy|
12046205|NCT00234208|Procedure|Simple chest tube drainage|
12046206|NCT00234195|Drug|bupropion extended release (Wellbutrin XL)|
12046207|NCT00234182|Drug|Interferon alpha-2b|
12046208|NCT00234169|Drug|VTP195183|"VTP195183: 60mg/m2 orally daily G-CSF: 10mcg/kg/day subcutaneously Provision is made for dose reduction of VTP195183 in the event of unexpected dose-limiting toxicities G-CSF10mcg/kg/day will commence on day 1 and will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.
~Patients will be treated with VTP195183 alone at 60mg/m2/day from day 1 to day 7. On day 8 VTP195183 will be continued and G-CSF10mcg/kg/day will be added. VTP195183 plus G-CSF will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first."
12046209|NCT00234156|Procedure|oral fructose and high fat diet|"High fat diet: The composition will be: 35% of energy as fat, 50% carbohydrate, 15% protein (~1.3 g/kg), sat:mono:poly 1:3:1, cholesterol 200 mg/d, 30% starch,15% sugar, 3% fructose, and 25 gm fiber/d. This relatively high fat diet, which falls within the recommendations by the National Kidney Foundation for hemodialysis patients, will suppress fatty acid synthesis in normal volunteers.
~Fructose in 360 ml water will be orally administered as 1.4 g/kg (~100 g or 400 kcal for a 70 kg person), divided into 30 mL (1 ounce) doses given every 1/2h for 6 hours."
12046210|NCT00234143|Behavioral|Darbepoetin and Filgrastim|Aranesp and Neupogen G-CSF (Neupogen) 300 mcg s.c. twice a week, 3-4 days apart and EPO (Aranesp) 500 mcg s.c. once every 2 weeks until week 24, titrate depending of response
12046211|NCT00234143|Drug|Darbepoetin|Aranesp EPO (Aranesp) 500 mcg s.c. once every 2 weeks until 24 weeks, titrate depending of response
12046212|NCT00234130|Procedure|nocturnal vs conventional dialysis|
12046213|NCT00234117|Drug|Rabeprazole|
12046214|NCT00234104|Drug|OPC-41061(Tolvaptan)|
12046215|NCT00234091|Drug|Abacavir|8 mg/kg (up to 300 mg/dose) take orally twice daily
12046216|NCT00234091|Drug|Efavirenz|200 to 600 mg taken orally once daily
12046217|NCT00234091|Drug|Lamivudine|4 mg/kg (up to 150 mg/dose) taken orally twice daily
12046218|NCT00234091|Drug|Lopinavir/Ritonavir|230 mg/57.5 mg/m^2 body surface area taken orally twice daily with food
12046219|NCT00234091|Drug|Nelfinavir|45-55 mg/kg taken orally twice daily with food
12046220|NCT00234091|Drug|Nevirapine|120 mg/m^2 once daily for first 14 days, tehn 200 mg/m^2 (up to 400 mg/day) twice daily
12046221|NCT00234091|Drug|Zidovudine|180-240 mg/m^2 every 12 hours (up to 300 mg/dose)
12046222|NCT00234078|Drug|0.5% OPC-12759|
12046223|NCT00234078|Drug|1% OPC-12759|
12046224|NCT00234078|Drug|2% OPC-12759|
12046225|NCT00234078|Drug|placebo|
12046226|NCT00234065|Drug|Cilostazol|oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
12046227|NCT00234065|Drug|Aspirin|oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
12046228|NCT00234052|Biological|bevacizumab|5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)
12046229|NCT00234052|Drug|carboplatin|Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)
12046230|NCT00234052|Drug|pemetrexed|Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)
12046231|NCT00234039|Drug|gemcitabine hydrochloride|
12046232|NCT00234026|Drug|gemcitabine hydrochloride|
12046233|NCT00234000|Drug|arsenic trioxide|Each 28-day treatment cycle will include dosing for 2 days per week of ATO. Subjects will recieve 1 mg/mL each dosing day.
12046234|NCT00234000|Drug|azacitidine|Each 28-day treatment cycle will include dosing the first five days of cycle with Azacitidine. Cohorts of three to six patients will each receive 25, 50, and 75 mg/m2/d injected subcutaneously.
12046235|NCT00233987|Drug|carmustine|150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant.
12046236|NCT00233987|Drug|cyclophosphamide|100 mg/kg IV 2 days before transplant.
12046237|NCT00233987|Drug|etoposide|60 mg/kg IV over 4 hours 4 days before transplant.
12046238|NCT00233987|Drug|melphalan|150 mg/m^2 IV 1 day before transplant.
12046239|NCT00233987|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|2.0 x 10^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.
12046240|NCT00233987|Radiation|radiation therapy|150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.
12046241|NCT00233974|Procedure|PET (positron emission tomography)|Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation
12046242|NCT00233961|Biological|filgrastim|
12046243|NCT00233948|Drug|nelfinavir mesylate|Given orally
12046244|NCT00233948|Procedure|biopsy|Correlative studies
12046245|NCT00233948|Other|laboratory biomarker analysis|Correlative studies
12046246|NCT00233948|Other|pharmacological study|Correlative studies
12046247|NCT00233948|Genetic|gene expression analysis|Correlative studies
12046248|NCT00233948|Genetic|western blotting|Correlative studies
12046249|NCT00233948|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
12046250|NCT00233948|Other|immunoenzyme technique|Correlative studies
12046251|NCT00233935|Other|placebo|Given PO
12046252|NCT00233935|Drug|defined green tea catechin extract|Given PO
12046253|NCT00233922|Device|Osteosheet(r)|
12046254|NCT00233909|Drug|Zosuquidar|
12046255|NCT00233909|Drug|gemtuzumab ozogamicin|
12046256|NCT00233896|Drug|Oral beclomethasone dipropionate (drug)|
12046257|NCT00233883|Drug|enfuvirtide [Fuzeon]|90mg sc bid by Biojector 2000 NFID for 4 weeks
12046258|NCT00233883|Drug|enfuvirtide [Fuzeon]|"90mg sc bid by 27G1/2 needle/syringe for 4 weeks"
12046259|NCT00233870|Drug|Agalsidase beta (recombinant form)|agalsidase beta 1.0 mg/kg body weight infused every 2 weeks as an intravenous infusion
12046260|NCT00233857|Procedure|Auricular acupuncture|
12046261|NCT00233844|Procedure|"Venipuncture with cough-trick"|
12046262|NCT00233831|Device|Generator of electromagnetic millimeter waves|
12046263|NCT00233818|Device|Sirolimus-coated Bx VELOCITY Stent|
12046264|NCT00233805|Device|Sirolimus coated Bx Velocity™|drug-eluting stent
12046265|NCT00233805|Device|Bare metal Bx Velocity™|bare-metal stent
12046266|NCT00233792|Device|sirolimus coated Bx VELOCITY stent - fast release|
12046267|NCT00233792|Device|sirolimus coated Bx VELOCITY stent - slow release|
12046268|NCT00233779|Device|SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT|
12046269|NCT00233766|Device|Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose|
12046270|NCT00233753|Device|Cordis Neurovascular Self-Expanding Stent|
12046271|NCT00233740|Device|OPTEASE Vena Cava Filter|
12046272|NCT00233727|Procedure|HPV DNA Testing + Cryosurgery|"Patients will undergo a Screen and Treat program utilizing HPV DNA testing of clinician-collected cervical samples, followed by cryosurgery of screen positive women."
12046273|NCT00233727|Procedure|VIA + Cryosurgery|"Patients will undergo a Screen and Treat program utilizing visual inspection of the cervix with acetic acid (VIA), followed by cryosurgery of screen positive women."
12046274|NCT00233714|Device|CYPHER Sirolimus-Eluting Coronary Stent|Single dose Sirolimus-Eluting coronary stent
12046275|NCT00233714|Device|CYPHER Sirolimus-Eluting Coronary Stent|Double-dose Sirolimus-Eluting coronary stent
12046276|NCT00233688|Device|QUANTUM LP™ STENT GRAFT SYSTEM|Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
12046277|NCT00233688|Procedure|Open surgical repair|Open surgical repair
12046278|NCT00233675|Drug|GABITRIL (tiagabine hydrochloride; CEP-6671)|
12046279|NCT00233662|Drug|Alefacept|
12046280|NCT00233636|Drug|Iressa (Gefitinib)|
12046281|NCT00233636|Procedure|Radiotherapy|
12046282|NCT00233623|Drug|Iressa (Gefitinib)|
12046283|NCT00233623|Drug|Irinotecan|
12046284|NCT00233623|Drug|5Fluorouracil|
12046285|NCT00233623|Drug|Leucovorin|
12046286|NCT00233610|Drug|Bicalutamide|
12046287|NCT00233610|Drug|Tamoxifen|
12046288|NCT00233597|Drug|ferumoxytol or oral iron|
12046289|NCT00233584|Procedure|Pulmicort (budesonide) pMDI|
12046290|NCT00233571|Biological|Adalimumab 40 mg subcutaneous (SC) every other week (EOW)|
12046291|NCT00233558|Drug|adalimumab (up to 9 months exposure)|
12046292|NCT00233558|Drug|methotrexate|
12046293|NCT00233545|Drug|miltefosine|
12046294|NCT00233545|Drug|antimony|
12046295|NCT00233532|Drug|Trandolapril|0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).
12046296|NCT00233519|Drug|SomatoKine/IPLEX|"Cohort 1: self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
~Cohort 2: consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection."
12046297|NCT00233506|Drug|CpG 7909|
12046298|NCT00233480|Drug|atorvastatin|atorvastatin 10mg PO QD
12046299|NCT00233480|Drug|placebo|matched placebo Qd x 3 months
12046300|NCT00233454|Drug|Midostaurin|Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR
12046301|NCT00233441|Drug|CELIVARONE (SSR149744C)|
12046302|NCT00233428|Procedure|Blood Draw|
12046303|NCT00233415|Device|Stereotactic Radiosurgery (Cyberknife)|
12046304|NCT00233402|Drug|Hexvix|Single Instillation, Transurethral Resection of the Bladder
12046305|NCT00233402|Procedure|Standard white light cystoscopy|
12046306|NCT00233389|Drug|Rebamipide|
12046307|NCT00233376|Procedure|Access to an antibiotic decision support system|
12046308|NCT00233376|Behavioral|Distribution of local antibiotic guidelines|
12046309|NCT00233363|Drug|Rebamipide|
12046310|NCT00233350|Device|use of navigated 3D ultrasound during surgery|
12046311|NCT00233337|Drug|Co-artemether|
12046312|NCT00233324|Drug|Surfactant|Intubation and administration of surfactant by 1 hour of age.
12046313|NCT00233324|Device|Continuous Positive Airway Pressure (CPAP)|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
12046314|NCT00233324|Drug|Supplemental oxygen with target saturation of 85 to 89%|Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
12046315|NCT00233324|Drug|Supplemental oxygen with target saturation of 91 to 95%|Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
12046316|NCT00233259|Behavioral|Mediterranean Diet|Mediterranean dietary program
12046317|NCT00233259|Behavioral|Physical Activity|Physical activity program
12046318|NCT00233259|Behavioral|Stress Management|Stress management program
12046319|NCT00233259|Behavioral|Social Support|Social support
12046320|NCT00233259|Behavioral|Smoking Cessation|Smoking cessation program
12046321|NCT00233259|Other|Control group|Usual Diabetes Care Control group
12046322|NCT00233246|Procedure|FFP Infusion|
12046323|NCT00233233|Behavioral|Standardized Asthma Education Program|
12046324|NCT00233220|Behavioral|Multicomponent, multi-level intervention targeted at physicians and patients|The patient intervention will include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial.
12046325|NCT00233220|Behavioral|Usual Care|Patients will receive usual care.
12046326|NCT00233207|Drug|IC14|
12046327|NCT00233194|Procedure|Observational follow-up study of adenotonsillectomy|Studies of sleep, behavior, cognition, and daytime sleepiness
12046328|NCT00233181|Behavioral|Home-based adherence monitoring|
12046329|NCT00233168|Behavioral|Adherence Program|14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.
12046330|NCT00233168|Behavioral|Life Skills and Self-Esteem Training Program (Attention Control Arm)|Peer counseling session covering life skills (e.g., communication skills, goal setting, self-esteem) training, 14 sessions over 6 months beginning once per week and decreasing in frequency over time to once per month.
12046331|NCT00233155|Drug|Capsaicin Dermal Patch|
12046332|NCT00233142|Behavioral|Expressive writing|Writing as therapeutic intervention
12046333|NCT00233142|Behavioral|Neutral writing|Non-expressive writing
12046334|NCT00233129|Behavioral|Top Down|Six months
12046335|NCT00233129|Other|cognitive rehabilitation day treatment program|six months
12046336|NCT00233103|Drug|Sertraline|Sertraline arm
12046337|NCT00233103|Drug|Placebo|Placebo
12046338|NCT00233090|Drug|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
12046339|NCT00233090|Drug|Placebo|daily dose of placebo for four weeks.
12046340|NCT00233077|Behavioral|Patient Assistance|Patients will be surveyed to assess their knowledge about cancer & its treatment, experience with & access to health care system, trust, depression, social support & self-efficacy. A Brief Screening Needs Assessment will be done to ascertain practical, informational or psychosocial needs; based on their responses, an individualized action plan to connect with patient assistance programs will be created for the intervention group. We will ask intervention patients if they connected with any programs in their action plan. For those who didn't connect, we will give their name to an outreach worker. The outreach worker will call patients and identify reasons for not contacting the assistance programs.
12046341|NCT00233077|Behavioral|Information only|Control patients will be sent a pamphlet about breast cancer & its treatment. We will call all patients 2 weeks later and ask if they received the packet. If they didn't, we will send the packet again.
12046342|NCT00233064|Biological|Lyophilized Palivizumab|Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
12046343|NCT00233064|Biological|Liquid Palivizumab|Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
12046344|NCT00233051|Drug|Salmeterol or Salmeterol/Fluticasone|
12046345|NCT00233038|Procedure|Ethanol injection into a cyst|
12046346|NCT00233025|Drug|Duloxetine|
12046347|NCT00233025|Drug|Placebo|
12046348|NCT00233012|Drug|Topiramate|
12046349|NCT00232999|Drug|Nebulized IVX-0142|
12046350|NCT00232973|Drug|ICXP007|
12046351|NCT00232960|Procedure|Radiotherapy 50 Gy|
12046352|NCT00232947|Biological|Influenza virus vaccine (Fluviral)|
12046353|NCT00232947|Biological|Influenza virus vaccine (Fluzone)|
12046354|NCT00232934|Drug|Thalidomide|
12046355|NCT00232921|Drug|caudal volume 1|
12046356|NCT00232921|Biological|caudal volume 2|
12046357|NCT00232921|Drug|caudal volume 3|
12046358|NCT00232908|Drug|ARV regimen|As prescribed
12046359|NCT00232908|Drug|enfuvirtide [Fuzeon]|90mg sc bid for 12 weeks
12046360|NCT00232895|Drug|lipuro propofol|
12046361|NCT00232895|Drug|standard formulation propofol|
12046362|NCT00232882|Drug|Candesartan Thiazide|Candesartan 16 mg for 4 weeks then added hydrochlorothiazide for 4 weeks
12046363|NCT00232882|Drug|Atenolol Thiazide|Atenolol 100 mg for 4 weeks followed by atenolol 100 mg + hydrochlorothiazide 12.5 mg for 4 weeks
12046364|NCT00232882|Drug|Thiazide Candesartan|Thiazide 25 mg for 4 weeks then added with Candesartan 16 mg
12046365|NCT00232869|Device|drug-eluting stent|Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
12046366|NCT00232869|Device|bare-metal stent|SMART™ bare-metal stent
12046367|NCT00232856|Device|drug-eluting stent|PCI
12046368|NCT00232843|Device|stent|Cordis SMART™ nitinol self-expanding stent.
12046369|NCT00232843|Device|angioplasty|balloon angioplasty
12046370|NCT00232830|Device|drug-eluting stent|Cypher Sirolimus-eluting Coronary Stent
12046371|NCT00232830|Device|bare-metal stent|any bare-metal stent brand
12046372|NCT00232817|Drug|Nicotine (drug)|nicotine nasal spray (3mg) before surgery
12046373|NCT00232804|Device|Bx Cypher stent|
12046374|NCT00232791|Device|Cypher Select|CYPHER SELECT™ Sirolimus-eluting Coronary Stent
12046375|NCT00232791|Device|Cypher|CYPHER™ Sirolimus-eluting Coronary Stent
12046376|NCT00232778|Device|GAMMA-Iridium-192 catheter|
12046377|NCT00232765|Device|CYPHER Sirolimus-Eluting Stent|CYPHER Sirolimus-Eluting Stent
12046378|NCT00232765|Device|Uncoated BX VELOCITY Balloon-Expandable Stent|Uncoated BX VELOCITY Balloon-Expandable Stent
12046379|NCT00232752|Device|4.0 CYPHER Sirolimus-Eluting Coronary Stent|4.0 CYPHER Sirolimus-Eluting Coronary Stent
12046380|NCT00232739|Device|CYPHER Sirolimus-eluting Coronary Stent|2.25 Cypher Sirolimus-eluting Coronary Stent
12046381|NCT00232726|Drug|CP-4055 (ELACYT)|
12046382|NCT00232700|Drug|Escitalopram|
12046383|NCT00232687|Drug|Aripiprazole|Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
12046384|NCT00232687|Drug|Aripiprazole|Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, once daily, 12 weeks.
12046385|NCT00232674|Drug|Pulmicort (budesonide) Turbuhaler|
12046386|NCT00232661|Drug|ARIMIDEX (anastrazole)|
12046387|NCT00232661|Drug|NOLVADEX (tamoxifen)|
12046388|NCT00232648|Drug|Pulmicort (budesonide) Respules|
12046389|NCT00232635|Drug|A-60444|
12046390|NCT00232622|Drug|Streptokinase|Accelerated infusion of streptokinase
12046391|NCT00232622|Drug|Streptokinase|Standard dose streptokinase
12046392|NCT00232609|Device|GameCycle Exercise System|
12046393|NCT00232596|Drug|Retigabine|Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase
12046394|NCT00232596|Drug|Placebo|Oral tablet.
12046395|NCT00232583|Drug|Metformin|Metformin 1000mg/BID
12046396|NCT00232583|Drug|Insulin|Insulin Novolg 70/30 per protocol titration
12046397|NCT00232583|Drug|Metfomin|Metformin 1000mg/BID
12046398|NCT00232583|Drug|Pioglitazone|Pioglitazone 45mg
12046399|NCT00232583|Drug|glyburide|Glyburide per protocol titration
12046400|NCT00232570|Drug|quetiapine|
12046401|NCT00232557|Device|TLC-Asthma|Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens
12046402|NCT00232557|Device|TLC-health education|A telephone-linked communication system (TLC) to provide general health education.
12046403|NCT00232544|Device|Telecommunications system|The telecommunications system is designed to improve patient adherence with prescribed positive airway pressure.
12046404|NCT00232544|Other|TLC-Control|A TLC system for providing general health education
12046405|NCT00232531|Drug|Niaspan|
12046406|NCT00232518|Procedure|Infection with hookworm larvae|
12046407|NCT00232505|Biological|cetuximab|Given IV
12046408|NCT00232505|Drug|carboplatin|Given IV
12046409|NCT00232492|Drug|Placebo males|Intravenous saline bolus (Placebo-control) males
12046410|NCT00232492|Drug|Ketamine 0,1 mg/kg males|0,1 mg/kg ketamine iv bolus males
12046411|NCT00232492|Drug|Ketamine 0,3 mg/kg males|0,3 mg/kg ketamine iv bolus males
12046412|NCT00232492|Drug|Ketamine 0,5 mg/kg males|0,5 mg/kg ketamine iv bolus males
12046413|NCT00232492|Drug|Placebo females|Intravenous saline bolus (Placebo-control) females
12046414|NCT00232492|Drug|Ketamine 0,1 mg/kg females|0,1 mg/kg iv bolus ketamine females
12046415|NCT00232492|Drug|Ketamine 0,3 mg/kg females|0,3 mg/kg iv bolus ketamine females
12046416|NCT00232492|Drug|Ketamine 0,5 mg/kg females|0,5 mg/kg iv bolus ketamine females
12046417|NCT00232479|Drug|trastuzumab, docetaxel and carboplatin in dose dense regimen|trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44
12046418|NCT00232466|Procedure|Vertebroplasty|"Procedure:
~The treatment consists of a transpedicular injection of polymethylmethacrylate bone cement into the collapsed vertebral body (maximal 2 vertebrae in 1 treatment session) using fluoroscopic guidance. The procedure is performed under the use of local anesthetics and the patient can be discharged the same day or after 1 night of hospital stay."
12046419|NCT00232453|Procedure|Combined Radiation and Chemotherapy|
12046420|NCT00232440|Device|BodyFIX|
12046421|NCT00232427|Procedure|Hemodynamic monitoring system PiCCO|
12046422|NCT00232414|Drug|Quetiapine|
12046423|NCT00232388|Procedure|Blood draw|
12046424|NCT00232375|Drug|Insulin|
12046425|NCT00232362|Drug|Pioglitazone (Actos)|
12046426|NCT00232362|Drug|Anti-diabetic agent other than pioglitazone or rosiglitazone|
12046427|NCT00232349|Drug|galantamine|open label galantamine, dosed at 4-12 mg/b.i.d., with a target dose of 12 mg/b.i.d.
12046428|NCT00232336|Drug|quetiapine|
12046429|NCT00232323|Behavioral|simulation training|
12046430|NCT00232310|Drug|CELIVARONE (SSR149744C)|
12046431|NCT00232297|Drug|SSR149744C|
12046432|NCT00232284|Drug|sertraline|RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
12046433|NCT00232284|Behavioral|Cognitive Behavioural Therapy|An integrated 10-week CBT program for depression/anxiety and comorbid substance use
12046434|NCT00232271|Drug|Clexane|
12046435|NCT00232258|Drug|Nolpitantium besylate|
12046436|NCT00232245|Drug|Fish oil|
12046437|NCT00232232|Drug|Fish oil|
12046438|NCT00232219|Drug|Fish oil|
12046439|NCT00232206|Drug|Neoadjuvant Therapy with Cisplatin Plus Docetaxel|
12046440|NCT00232180|Drug|Eplerenone|Eplerenone administered on top of background standard heart failure therapy
12046441|NCT00232167|Drug|Indiplon|
12046442|NCT00232167|Drug|Sertraline|
12046443|NCT00232154|Drug|Zithromax&#153; (azithromycin) 500mg tablets|
12046444|NCT00232154|Procedure|Endoscopic Sinus Surgery|
12046445|NCT00232154|Procedure|Blood sampling for hematology|
12046446|NCT00232154|Procedure|Blood sampling for plasma chemistry profile|
12046447|NCT00232154|Procedure|Serum pregnancy test (for women of child-bearing potential)|
12046448|NCT00232141|Drug|pregabalin|75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)
12046449|NCT00232141|Drug|Placebo|Placebo
12046450|NCT00232128|Procedure|Radiofrequency Ablation of pulmonary neoplasms|
12046451|NCT00232115|Drug|Pimecrolimus|Pimecrolimus cream 1 %
12046452|NCT00232115|Drug|Placebo|Vehicle cream (placebo)
12046453|NCT00232102|Drug|Tegaserod|
12046454|NCT00232089|Drug|Tegaserod|
12046455|NCT00232076|Drug|ciclosporin|
12046456|NCT00232063|Drug|ciclosporin|
12046457|NCT00232050|Drug|Omalizumab|
12046458|NCT00232037|Drug|Tegaserod|
12046459|NCT00232024|Drug|Tegaserod|
12046460|NCT00232011|Drug|Pimecrolimus Cream 1%|Pimecrolimus cream 1 %
12046461|NCT00231998|Drug|Pimecrolimus|Pimecrolimus cream 1 %
12046462|NCT00231985|Behavioral|Habit reversal therapy|Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.
12046463|NCT00231985|Behavioral|Supportive therapy|Supportive therapy focuses on educating participants about tics: how tics present themselves, the causes of tics, the common conditions that may occur along with tics, and environmental factors that may affect their tics (e.g. family, social, school, stress).
12046464|NCT00231972|Behavioral|Project Enhance|The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
12046465|NCT00231972|Behavioral|Standard prevention case management (PCM)|Participants will receive standard PCM for HIV prevention.
12046466|NCT00231959|Drug|Pramipexole (Mirapex)|pramipexole 0.5mg tablets qd and titrated per protocol
12046467|NCT00231959|Drug|Placebo|sugar pill
12046468|NCT00231946|Drug|VP4896|
12046469|NCT00231933|Behavioral|Person-centered planning (PCP)|PCP aids participants in discovering a vision of a desirable future and developing a plan for achieving that goal. Techniques include providing direction in the planning process, involving significant others, generating focus on assets and capacities, identifying and providing access to integrated community settings, and promoting acceptance of set backs as part of the path to success.
12046470|NCT00231933|Behavioral|Community integration (CI)|CI includes recovery group sessions and community integration activities.
12046471|NCT00231933|Behavioral|Illness management recovery (IMR)|IMR focuses on nine topic areas: recovery strategies; facts about psychosis; a stress-vulnerability model; building social support; reducing relapses; effective use of medications; coping with stress; coping with problems or symptoms; and meeting health care needs.
12046472|NCT00231920|Biological|Fluzone|
12046473|NCT00231907|Biological|FluMist|Live attenuated influenza vaccine (LAIV) containing approximately 10^7 TCID50 of each of the 3 influenza strains. 0.5 mL total dose volume administered intranasally via spray applicator (approximately 0.25 mL into each nostril). Administration of Flumist in children under 5 years of age is investigational.
12046474|NCT00231907|Biological|Fluzone|Trivalent inactivated vaccine (TIV), licensed Fluzone preservative free pediatric dose, 0.25 mL administered intramuscularly to the anterolateral thigh muscle or deltoid muscle.
12046475|NCT00231894|Drug|Pioglitazone|pioglitazone 30-45 mg/day
12046476|NCT00231894|Behavioral|Life style diet group|life style diet education group 1x/week
12046477|NCT00231894|Other|Placebo|placebo comparator capsules
12046478|NCT00231868|Drug|Carboplatin and Paclitaxel and Pelvic Radiation Therapy|Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
12046479|NCT00231868|Procedure|Carboplatin and Paclitaxel and Pelvic Radiation Therapy|Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
12046480|NCT00231868|Drug|Carboplatin and Paclitaxel and Radiation Therapy|Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
12046481|NCT00231855|Drug|Topotecan and Taxotere|
12046482|NCT00231842|Drug|Ifosfamide|Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg/IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.
12046483|NCT00231842|Device|Radiation Therapy|Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg /IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.
12046484|NCT00231842|Drug|Cisplatin|dosage is 20 mg/m2/day for 5 days, ever 3 weeks.
12046485|NCT00231829|Drug|Celecoxib|
12046486|NCT00231816|Biological|ZOSTAVAX™ (concomitant)|a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4
12046487|NCT00231816|Biological|Comparator: Influenza Vaccine|a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
12046488|NCT00231816|Biological|ZOSTAVAX™ (Nonconcomitant)|Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4
12046489|NCT00231803|Procedure|Combined CKD and CVD Prevention|
12046490|NCT00231803|Procedure|Cardiovascular Disease prevention|
12046491|NCT00231803|Procedure|Treatment of Chronic Kidney Disease complications|
12046492|NCT00231790|Drug|MK-0634 50 mg|one capsule orally, once daily in morning
12046618|NCT00230698|Drug|topiramate|
12046493|NCT00231790|Drug|MK-0634 125 mg|one or three capsules orally, once daily in morning
12046494|NCT00231790|Drug|Placebo for MK-0634|one, two, three or four capsules orally once daily in morning
12046495|NCT00231777|Drug|Comparator: MK0517|a single administration of 40 mg MK0517 by IV immediately prior to surgery
12046496|NCT00231777|Drug|Comparator: ondansetron|a single administration of 4 mg ondansetron by IV immediately prior to surgery
12046497|NCT00231764|Drug|daclizumab|
12046498|NCT00231738|Drug|Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)|
12046499|NCT00231725|Drug|insulin lispro injection [rDNA origin] Low Mix|
12046500|NCT00231699|Procedure|Plastic wrap (study group) and cotton (control group) wrap.|
12046501|NCT00231686|Behavioral|Supervised aerobic training|
12046502|NCT00231686|Behavioral|Supervised strength training|
12046503|NCT00231686|Behavioral|Unsupervised training|
12046504|NCT00231673|Drug|Topiramate|Increasing dosing of topiramate gradually to 200 mg daily by mouth, dose maintenance for 12 weeks, then decreasing dose until stopped over 12 weeks
12046505|NCT00231660|Drug|topiramate|
12046506|NCT00231647|Drug|topiramate|
12046507|NCT00231634|Drug|topiramate|
12046508|NCT00231621|Drug|topiramate|
12046509|NCT00231608|Drug|topiramate|
12046510|NCT00231595|Drug|topiramate|
12046511|NCT00231582|Drug|epirubicin|epirubicin
12046512|NCT00231582|Procedure|high-dose and autologous stem cell transplantation|high-dose and autologous stem cell transplantation
12046513|NCT00231582|Drug|paclitaxel|paclitaxel
12046514|NCT00231582|Drug|etoposide|etoposide
12046515|NCT00231582|Drug|ifosfamide|ifosfamide
12046516|NCT00231582|Drug|carboplatin|carboplatin
12046517|NCT00231569|Drug|ISIS 301012 or Placebo|30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
12046518|NCT00231569|Drug|ISIS 301012 or Placebo|100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
12046519|NCT00231569|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
12046520|NCT00231569|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
12046521|NCT00231569|Drug|ISIS 301012 or Placebo|400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
12046522|NCT00231569|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
12046523|NCT00231569|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
12046524|NCT00231556|Drug|topiramate|
12046525|NCT00231543|Procedure|Laparoscopic fundoplication|
12046526|NCT00231543|Procedure|open Nissen fundoplication|
12046527|NCT00231530|Drug|topiramate|
12046528|NCT00231517|Drug|topical opiod|
12046529|NCT00231517|Drug|morphine sulphate in intrasite gel|
12046530|NCT00231504|Procedure|Blood samples|Blood samples
12046531|NCT00231491|Drug|Botulinum Toxin A (Botox )|
12046532|NCT00231478|Drug|granisetron|20 micrograms intravenously (iv) 15 min prior to end of surgery
12046533|NCT00231478|Drug|granisetron|40 micrograms intravenously (iv) 15 min prior to end of surgery
12046534|NCT00231465|Drug|docetaxel (Taxotere®)|Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
12046535|NCT00231465|Drug|ZD1839|ZD1839 will be continued until progression, or until trial closure, whichever comes first.
12046536|NCT00231452|Drug|Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)|Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the following age-based dosing schedule: ½ tablet of SP or placebo and ½ tablet of AS or placebo on the first day and ½ tablet of AS or placebo on the second and third days.
12046537|NCT00231439|Drug|IvIg|
12046538|NCT00231426|Device|ICD|
12046539|NCT00231413|Biological|HPV 16/18 L1 AS04|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
12046540|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 1|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
12046541|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 2|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
12046542|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 3|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
12046543|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 4|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
12046544|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 5|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
12046545|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 6|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
12046546|NCT00231387|Drug|rosiglitazone|
12046547|NCT00231374|Procedure|Myelogram|
12046548|NCT00231348|Drug|Nefazodone|
12046549|NCT00231335|Drug|escitalopram|
12046550|NCT00231322|Drug|praziquantel|
12046551|NCT00231309|Drug|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor
12046552|NCT00231296|Device|Cardiac CryoCor Cryoablation System|Treatment with CryoCor Cardiac Cryoablation system
12046553|NCT00231296|Drug|Medical management|Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
12046554|NCT00231283|Device|CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
12046555|NCT00231270|Device|Cordis Nitinol Stent|
12046556|NCT00231270|Device|PRECISE tapered stent|
12046557|NCT00231270|Device|ANGIOGUARD XP Emboli Capture Guidewire (ECGW)|
12046558|NCT00231257|Device|Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent|Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
12046559|NCT00231257|Procedure|Brachytherapy|Brachytherapy
12046560|NCT00231244|Device|CYPHER Sirolimus-Eluting Coronary Stent|CYPHER Sirolimus-Eluting Coronary Stent
12046561|NCT00231231|Device|-PRECISE Nitinol Stent System (5F, 5.5F and 6F)|
12046562|NCT00231231|Device|ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)|
12046563|NCT00231218|Drug|dietary supplement--echinacea, propolis, and vitamin c|
12046564|NCT00231205|Procedure|Revascularization|
12046565|NCT00231192|Drug|Repaglinide and Insulin|
12046566|NCT00231179|Behavioral|Home visiting professional support model|Home visits and telephone calls keyed to well child visits.
12046567|NCT00231179|Other|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information
12046568|NCT00231166|Drug|HCD122|
12046569|NCT00231153|Drug|Omiganan 1% gel|Patients randomized to omiganan group will receive an application of omiganan gel around the catheter insertion site following catheter insertion. Every 3 days the dressing will be changed and patients will receive a new application of Omiganan 1% gel.
12046570|NCT00231153|Drug|Povidone-Iodine 10%|All CVC sites will be disinfected using a 10% povidone-iodine scrub for a minimum of 2 minutes prior to catheter insertion. Patients randomized to the povidone-iodine group will receive no further antiseptic treatment after catheter insertion until dressing changes. Every three days the dressing will be changed and the catheter site will be sterilized with povidone-iodine.
12046571|NCT00231140|Drug|Thalidomide (drug)|
12046572|NCT00231114|Device|Alair System|Treatment of airways with the Alair System
12046573|NCT00231114|Device|Alair System|Sham treatment of airways with the Alair System
12046574|NCT00231101|Drug|Quetiapine|
12046575|NCT00231075|Drug|Paraplatin|
12046576|NCT00231075|Drug|Paclitaxel|
12046577|NCT00231062|Device|Sinuplasty|
12046578|NCT00231049|Drug|AG-707|
12046579|NCT00231023|Drug|Peribulbar Triamcinolone Acetonide|
12046580|NCT00230997|Drug|Galantamine|
12046581|NCT00230984|Behavioral|education|
12046582|NCT00230984|Drug|Oral dietary supplements (563 kcal/d), RESPIFOR|
12046583|NCT00230984|Behavioral|exercises on an ergometric bicycle 3 to 5 times a week|
12046584|NCT00230984|Drug|160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women|
12046585|NCT00230971|Drug|tigecycline|every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
12046586|NCT00230971|Drug|ceftriaxone plus metronidazole|Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
12046587|NCT00230958|Drug|Viramidine|
12046588|NCT00230958|Drug|Ribavirin|
12046589|NCT00230958|Drug|pegylated interferon alfa-2b|
12046590|NCT00230945|Behavioral|education and support intervention|The patient-oriented education and support intervention (PES) is based on the Arthritis Self-Management Program, a group intervention that consists of 6 weekly 2 hour sessions shown to successfully reduce pain severity and depressive symptomatology and to enhance a sense of efficacy in managing arthritis pain and other symptoms. The couple-oriented education and support intervention (CES) is a group education and support intervention that consisted of 6 weekly 2 hour sessions attended by individuals with OA and their spouses. All components of the PES are covered in the CES using the standard format, and topics are framed as couples' issues whenever possible.
12046591|NCT00230919|Behavioral|Diet counseling|
12046592|NCT00230906|Procedure|Haemodialysis with either low or high flux membranes|
12046593|NCT00230880|Behavioral|follow-up phone counseling|9 calls over 12 months
12046594|NCT00230867|Device|iontophoretic acyclovir|
12046595|NCT00230854|Drug|EMZ702|
12046596|NCT00230841|Device|nebulized humidity|
12046597|NCT00230828|Drug|bifeprunox|
12046598|NCT00230815|Device|Follitropin alfa injected by Pen device|Follitropin alfa will be injected subcutaneously by Pen device at a dose of 75 International Unit (IU) and 150 IU in subjects aged 18-34 and 35-40 years, respectively, for 5 days. Dose will be adjusted on stimulation Day 6 until ovulation triggering criteria will met.
12046599|NCT00230815|Device|Recombinant Human Choriogonadotropin (r-hCG)|Recombinant Human Choriogonadotropin (r-hCG) injection will be administered as a single dose of 250 microgram subcutaneously when at least 1 follicle, but not more than 3 follicles, reached a mean diameter greater than or equal to (>=)17 mm and estradiol levels are approximately 150 picogram per milliliter (pg/mL) per mature follicle.
12046600|NCT00230802|Drug|Anticipatory dose increase of levothyroxine|as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
12046601|NCT00230802|Drug|levothyroxine|patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
12046602|NCT00230802|Drug|levothyroxine|patients will increase levothyroxine by 3 extra tablets of their current dose per week.
12046603|NCT00230789|Drug|Tolterodine ER 4 mg QD|
12046604|NCT00230789|Behavioral|OAB Patient Behavioral Training Material|
12046605|NCT00230776|Drug|pregabalin|
12046606|NCT00230776|Drug|placebo|
12046607|NCT00230763|Procedure|GSS questionnaire|D0, D30 and D84
12046608|NCT00230763|Procedure|IOP|D0, D30 and D84
12046609|NCT00230763|Drug|LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION|in the evening during 84 days
12046610|NCT00230763|Procedure|Visual acuity|D0 and D84
12046611|NCT00230750|Biological|Influenza A/H5N1 Vaccine|Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 90-mcg/mL. Dosages: 45 mcg or 90 mcg administered intramuscularly.
12046612|NCT00230750|Drug|Placebo|Saline placebo.
12046613|NCT00230737|Drug|Melatonin 0.4 mg|
12046614|NCT00230737|Drug|Melatonin 4.0 mg|
12046615|NCT00230737|Drug|Placebo|
12046616|NCT00230724|Behavioral|Exercise Counseling|
12046617|NCT00230711|Behavioral|Physical activity counseling|
12046619|NCT00230659|Other|Blood sample to be taken.|Blood sample to be taken.
12046620|NCT00230646|Behavioral|Exercise counseling|
12046621|NCT00230607|Drug|agalsidase beta|Pharmaceutical form: powder for reconstitution Route of administration: intravenous
12046622|NCT00230594|Drug|desmopressin|desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
12046623|NCT00230594|Drug|placebo|placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
12046624|NCT00230581|Drug|DDP225|
12046625|NCT00230568|Drug|Aricept|
12046626|NCT00230555|Behavioral|professional support model|
12046627|NCT00230542|Drug|Carboplatin|Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)
12046628|NCT00230542|Drug|Pemetrexed|Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)
12046629|NCT00230529|Drug|infliximab|
12046630|NCT00230516|Drug|Nexium|
12046631|NCT00230516|Drug|Prevacid|
12046632|NCT00230503|Drug|pradefovir mesylate|
12046633|NCT00230503|Drug|adefovir dipivoxyl|
12046634|NCT00230490|Drug|pradefovir mesylate|
12046635|NCT00230490|Drug|adefovir dipivoxyl|
12046636|NCT00230477|Drug|Hepsera|
12046637|NCT00230477|Drug|Hepsera and lamivudine|
12046638|NCT00230464|Drug|LAF 237|
12046639|NCT00230451|Procedure|Radiation|
12046640|NCT00230451|Drug|Paclitaxel|
12046641|NCT00230451|Drug|Cisplatin|
12046642|NCT00230451|Drug|5-Fluorouracil|
12046643|NCT00230438|Procedure|External Beam Radiotherapy|
12046644|NCT00230399|Drug|Celecoxib|
12046645|NCT00230399|Drug|Capecitabine|
12046646|NCT00230399|Drug|Irinotecan|
12046647|NCT00230386|Device|MRI|
12046648|NCT00230373|Drug|imiquimod 5% cream (Aldara)|
12046649|NCT00230347|Procedure|Stereotactic radiosurgery|
12046650|NCT00230334|Drug|Gleevec|
12046651|NCT00230321|Drug|Darbepoetin alfa|During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously.If patients do not achieve a major erythroid response by 6 weeks, the dose of DARBEPOETIN ALFA will be doubled to 9.0 ug/kg/week.
12046652|NCT00230295|Procedure|IMR LAG|
12046653|NCT00230282|Drug|Alemtuzumab|3 to 30 mg, IV
12046654|NCT00230282|Drug|Fludarabine|[(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl]methoxyphosphonic acid
12046655|NCT00230282|Drug|Cytoxan|(RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide
12046656|NCT00230269|Procedure|PET-CT|
12046657|NCT00230230|Drug|SCH 486757|
12046658|NCT00230217|Drug|Rasburicase (SR29142)|
12046659|NCT00230204|Procedure|Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits|
12046660|NCT00230191|Drug|RK-0202|
12046661|NCT00230178|Drug|Rasburicase (SR29142)|30-min IV infusion
12046662|NCT00230178|Drug|Allopurinol|Oral administration
12046663|NCT00230152|Device|Imaging|
12046664|NCT00230139|Device|SPECT/CT|
12046665|NCT00230126|Drug|erlotinib|Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
12046666|NCT00230113|Dietary Supplement|Omega-3 fatty acid diet supplementation|4 gm fish oil per day
12046667|NCT00230113|Dietary Supplement|safflower oil|4 gm per day safflower oil
12046668|NCT00230100|Behavioral|The Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
12046669|NCT00230100|Behavioral|mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
12046670|NCT00230087|Procedure|blood donation|phlebotomy until iron depleted
12046671|NCT00230074|Drug|TCH346|
12046672|NCT00230061|Biological|HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml|
12046673|NCT00230048|Behavioral|Brief computer-delivered intervention|Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.
12046674|NCT00230035|Procedure|Leukapheresis|
12046675|NCT00230035|Procedure|Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT)|
12046676|NCT00230035|Procedure|Autologous CD34+HPC transplantation (HSCT)|
12046677|NCT00230035|Procedure|Plasmapheresis|
12046678|NCT00230035|Drug|Rabbit anti-thymocyte globulin|
12046679|NCT00230035|Drug|Methylprednisolone|
12046680|NCT00230035|Drug|Growth colony stimulating factor (G-CSF)|
12046681|NCT00230035|Drug|Corticosteroids|
12046682|NCT00230035|Drug|Mycophenolate mofetil|
12046683|NCT00230035|Drug|Azathioprine|
12046684|NCT00230035|Drug|Intravenous immunoglobulin|
12046685|NCT00230035|Drug|Methotrexate|
12046686|NCT00230035|Drug|Rituximab|
12046687|NCT00230035|Drug|Leflunomide|
12046688|NCT00230022|Behavioral|Brief computer-delivered intervention|20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.
12046689|NCT00230009|Behavioral|Brief motivational intervention|
12046690|NCT00229996|Drug|Oral Contraceptive|
12046691|NCT00229996|Drug|Depot-Leuprolide/Norethindrone|
12046692|NCT00229983|Behavioral|Motivational Enhancement Therapy|Three 60 minute counseling sessions using a structured, developmentally appropriate approach to identification of drug- and alcohol- related risks and problems, and establishment of goals for behavioral change.
12046693|NCT00229970|Drug|montelukast sodium|7 mg or 14 mg single injection
12046694|NCT00229970|Drug|Comparator: Placebo|Placebo single injection
12046695|NCT00229957|Behavioral|Occupational therapy|
12046696|NCT00229957|Behavioral|Physiotherapy|
12046697|NCT00229957|Behavioral|Self-management|
12046698|NCT00229944|Drug|Azithromycin|
12046699|NCT00229931|Drug|Triamcinolone acetonide|4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
12046700|NCT00229931|Procedure|laser|Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
12046701|NCT00229918|Drug|triamcinolone acetonide|
12046702|NCT00229840|Procedure|Functional MRI, Diffusion Tensor Imaging|
12046703|NCT00229801|Radiation|MRI|
12046704|NCT00229775|Drug|artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine|
12046705|NCT00229762|Behavioral|phone call from nurses - informational only|
12046706|NCT00229749|Drug|AVI-4065 Injection|
12046707|NCT00229736|Genetic|AAV-hAADC-2|9 x 10^10 vector genomes (vg) of AAV-hAADC-2 in a single dose of 200 µL bilaterally infused over 4 striatal targets
12046708|NCT00229736|Genetic|AAV-hAADC-2|3 x 10^11 vector genomes (vg) of AAV-hAADC-2 in a single dose of 200 µL bilaterally infused over 4 striatal targets
12046709|NCT00229723|Drug|gefitinib (Iressa)|250 mg oral tablet
12046710|NCT00229723|Drug|cisplatin|intravenous infusion
12046711|NCT00229723|Radiation|radiotherapy|radiation therapy
12046712|NCT00229723|Drug|Gefitinib (Iressa)|500 mg oral tablet
12046713|NCT00229710|Drug|Tesaglitazar|0.5 in combination with insulin (with or without other oral antidiabetic drugs)
12046714|NCT00229697|Drug|Gefitinib|
12046715|NCT00229697|Drug|Tamoxifen|
12046716|NCT00229684|Drug|Tesaglitazar|2 mg once daily in oral form
12046717|NCT00229684|Drug|pioglitazone|45 mg once daily in oral form
12046718|NCT00229671|Other|Survey 1|During the initial survey, we reviewed dispensed medications by having parents of patients with prescriptions under 21 read the medication label. We then asked questions about potential side effects, method of medication administration, communication regarding the medication with the pharmacist and the health care provider, and demographic information. Research assistants underwent several weeks of training to ensure a standardized approach to surveys.
12046719|NCT00229671|Other|Survey 2|If the parent completed the initial survey, we attempted a second survey 2 months after the index visit to capture persistent symptoms. Surveys were translated and back translated into Spanish and Cambodian and conducted by fluent bilingual interviewers. Surveys were pretested and revised based on 2 focus groups of parents representing a broad array of socioeconomic backgrounds.
12046720|NCT00229658|Drug|pramlintide acetate|Subcutaneous injection prior to each major meal
12046721|NCT00229645|Drug|Quetiapine Fumarate (Seroquel®)|
12046722|NCT00229632|Drug|Idebenone|Idebenone is a short-chain benzoquinone derivative of similar structure to ubiquinone (coenzyme Q10). This compound was synthesized and developed initially by Takeda Chemical Industries, Ltd. (Osaka, Japan) and designated as CV-2619. The chemical name for idebenone is 6-(10-Hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benxoquinone. Santhera Pharmaceuticals (Liestal, Switzerland) LLC, will supply drug for this study as specified by a clinical trial agreement.
12046723|NCT00229619|Drug|Rituximab|Rituximab (Rituxan) 375mg/m2 intravenous infusion. The infusion will be once every week for a total of 4 doses.
12046724|NCT00229593|Drug|Nestorone gel|2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
12046725|NCT00229593|Drug|Testosterone Gel|100 mg Testosterone gel daily for 3 weeks
12046726|NCT00229580|Behavioral|3 session brief intervention with health behavior feedback|
12046727|NCT00229580|Other|treatment as usual|
12046728|NCT00229567|Drug|Lidocaine infusion plus ketamine injection|
12046729|NCT00229541|Procedure|Counselling and 3-week medical in-patient rehabilitation|Counselling and 3-week medical in-patient rehabilitation in IG
12046730|NCT00229528|Drug|Paxil-CR|
12046731|NCT00229515|Other|abciximab followed by implantation of bare metal stent|Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
12046732|NCT00229515|Other|abciximab and Sirolimus eluting stent|Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
12046733|NCT00229515|Other|tirofiban and bare metal stent|Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with bare metal stent implantation
12046734|NCT00229515|Other|tirofiban and sirolimus-eluting stent|Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with sirolimus-eluting stent implantation
12046735|NCT00229476|Drug|sertraline (Zoloft)|
12046736|NCT00229450|Drug|Estrogen|0.625 mg/day of conjugated Estrogen
12046737|NCT00229437|Drug|TAK-128|TAK-128 5 mg, tablets, orally, once daily for up to 6 months.
12046738|NCT00229437|Drug|TAK-128|TAK-128 50 mg, tablets, orally, once daily for up to 6 months.
12046739|NCT00229437|Drug|TAK-128|TAK-128 100 mg, tablets, orally, once daily for up to 6 months.
12046740|NCT00229437|Drug|Placebo|TAK-128 placebo-matching tablets, orally, once daily for up to 6 months.
12046741|NCT00229424|Drug|Lafutidine|Oral administration of lafutidine by 20mg/day along with famotidine placebo
12046742|NCT00229424|Drug|Famotidine|Oral administration of famotidine by 40mg/day along with lafutidine placebo
12046743|NCT00229424|Other|Placebo|Oral administration of lafutidine placebo along with famotidine placebo
12046744|NCT00229411|Behavioral|simulation training|
12046745|NCT00229385|Drug|Ziprasidone|40-80 mg BID
12046746|NCT00229372|Behavioral|Prolonged Exposure (PE) therapy|
12046748|NCT00229320|Behavioral|Group therapy|
12046749|NCT00229307|Behavioral|Prolonged Exposure (PE) therapy|20 minutes exposure
12046750|NCT00229307|Behavioral|Prolonged Exposure (PE) therapy|40 minutes exposure
12046751|NCT00229281|Behavioral|Group therapy|
12046752|NCT00229255|Other|high frequency of meals|high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
12046753|NCT00229255|Other|twice a day meals|high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
12046754|NCT00229242|Drug|Diuretic-Based or Non-Diuretic Based Hypertension Therapy|
12046755|NCT00229229|Other|Low glycemic load diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
12046756|NCT00229229|Other|Canada Food Guide Diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
12046757|NCT00229229|Other|Low glycemic index diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
12046758|NCT00229229|Other|Low carbohydrate diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
12046759|NCT00229216|Drug|Tinidazole|
12046760|NCT00229203|Drug|Plitidepsin|3-hour infusion every 2 weeks alone or in combination with dexamethasone
12046761|NCT00229190|Procedure|Nasal lavage|
12046762|NCT00229190|Procedure|Allergy skin testing|
12046763|NCT00229190|Procedure|Peak nasal inspiratory flow|
12046764|NCT00229190|Procedure|Acoustic rhinometry|
12046765|NCT00229190|Procedure|Nasal examination|
12046766|NCT00229190|Procedure|Quality of Life Questionnaire|
12046767|NCT00229190|Procedure|Physical examination|
12046768|NCT00229177|Drug|ONO-2506|Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
12046769|NCT00229177|Drug|ONO-2506|Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
12046770|NCT00229177|Drug|ONO-2506|Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
12046771|NCT00229164|Device|Transcutaneous Electric Nerve Stimulation (TENS)|
12046772|NCT00229151|Behavioral|Sleep deprivation and sleep phase advancement|Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.
12046773|NCT00229151|Other|usual treatment|Treatment as usual in the psychiatric ward. Patients in this group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria
12046774|NCT00229138|Drug|EC-MPS, Tacrolimus|
12046775|NCT00229125|Drug|Gabapentin|
12046776|NCT00229125|Drug|Lorazepam|
12046777|NCT00229112|Drug|MK0826, ertapenem sodium / Duration of Treatment - 24 weeks|
12046778|NCT00229112|Drug|Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks|
12046779|NCT00229099|Drug|GerEPO|
12046780|NCT00229086|Device|Gatekeeper Reflux Repari System (Device)|
12046781|NCT00229073|Drug|dapoxetine|
12046782|NCT00229060|Drug|doripenem|
12046783|NCT00229021|Drug|doripenum|
12046784|NCT00229008|Drug|ceftobiprole plus placebo|ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
12046785|NCT00229008|Drug|linezolid plus ceftazidime|linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days
12046786|NCT00228995|Drug|epoetin alfa|
12046787|NCT00228982|Drug|Ceftobiprole medocaril|
12046788|NCT00228982|Drug|Vancomycin|
12046789|NCT00228969|Drug|RWJ-333369|
12046790|NCT00228956|Drug|pharmacodynamic analysis|Exemestane 25mg po daily or Letrozole 2.5mg po daily
12046791|NCT00228943|Dietary Supplement|Acute tryptophan depletion|L-alanine (5.5g), L-arginine (4.9g), L-cysteine (2.7g), glycine (3.2g), L-histidine (3.2g), L-isoleucine (8.0g), L-leucine (13.5g), L-lysine (11.0g), L-methionine (3.0g), L-phenylalanine (5.7g), L-proline (12.2g), L-serine (6.9g), L-threonine (6.9g), L-tyrosine (6.9g), L-valine (8.9g)
12046792|NCT00228943|Dietary Supplement|Half-strength tryptophan depletion (Control)|L-alanine (1.4g), L-arginine (1.2g), L-cysteine (0.7g), glycine (0.8g), L-histidine (0.8g), L-isoleucine (2.0g), L-leucine (3.4g), L-lysine (2.8g), L-methionine (0.8g), L-phenylalanine (1.4g), L-proline (3.1g), L-serine (1.7g), L-threonine (1.7g), L-tyrosine (1.7g), L-valine (2.2g), and fillers (7.95g).
12046793|NCT00228930|Drug|Tamoxifen (pharmacodynamic analysis)|Tamoxifen 20mg po daily
12046794|NCT00228917|Biological|Tritanrix-HepB/Hib-MenAC|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
12046795|NCT00228917|Biological|Tritanrix-HepB/Hiberix|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
12046796|NCT00228917|Biological|Mencevax-ACWY|Meningococcal Serogroups A, C, W-135 and Y Vaccine
12046797|NCT00228904|Procedure|Placebo|Control patients diagnosed with diabetic neuropathy are tested at baseline and every six months thereafter to compare to patients treated with pulsatile intravenous insulin therapy
12046798|NCT00228904|Procedure|Pulsatile IV insulin delivery (humalog, humulin, novolog)|Patients with diagnosed diabetic neuropathy have objective testing and questionnaires performed at baseline and every six months thereafter to evaluate and analyze progress of diabetic neuropathy after start of treatment of pulsatile intravenous insulin therapy
12046799|NCT00228891|Procedure|Effect of Pulsatile IV insulin on diabetic neuropathy|Control patients with diagnosed diabetic neuropathy will have objective testing at baseline and every six months to compare and measure results to patients receiving pulsatile intravenous insulin therapy.
12046800|NCT00228891|Procedure|Effect of Pulsatile IV Insulin on diabetic neuropathy|Patients diagnosed with diabetic neuropathy will be treated with pulsatile intravenous insulin on a weekly basis. Patient's Endocrinologist will determine the dosage of intravenous insulin to be given each week based upon the patient's response and insulin resistance.
12046801|NCT00228878|Procedure|Effects of Pulsatile IV insulin on Diabetic Quality of Life|Patients receive weekly treatments of Pulsatile Intravenous insulin therapy. The patient's Endocrinologist determines the insulin dosage each week based upon the patient's response to treatment and their insulin resistance.
12046947|NCT00227565|Drug|pemetrexed disodium|
12046948|NCT00227565|Radiation|radiation|
12046949|NCT00227539|Drug|cisplatin|
12046802|NCT00228865|Procedure|Pulsatile IV insulin therapy|Diabetic pts are given pulsatile iv insulin on a weekly basis determined by weekly phys orders based on pt response and insulin resistance. Cognitive testing is performed quarterly to track progress
12046803|NCT00228865|Procedure|Effects of Pulsatile IV Insulin on Cognitive functions|Diabetic patients receive weekly treatment of Pulsatile Intravenous Insulin therapy. Dosage is determined each week by the patient's Endocrinologist based upon the patient's response and insulin resistance.
12046804|NCT00228852|Drug|Busulfan, Fludarabine and ATG|
12046805|NCT00228839|Drug|Infliximab|
12046806|NCT00228813|Drug|Granulocyte Colony Stimulating Factor|"FILGRASTIM: G-CSF (NEUPOGEN®) is administered as a short IV infusion over 30 minutes or subcutaneously. It is given beginning on day -3 for 3 days to the donor prior to the bone marrow harvest.
~Drug Information: FILGRASTIM: G-CSF (Neupogen®) Formulation: G-CSF is available as a preservative-free solution for injection in 1.0 ml and 1.6 ml vials containing 300 mcg/ml.
~Administration: G-CSF 5 mcg/kg/d will be given subcutaneously or as a short I.V. infusion over 30 minutes.
~Recombinant GM-CSF at the dose of 250 mcg/m2 will be given intravenously from day +7 to help white counts recovery. The drug will be diluted in NS at a concentration of at least 10 mcg/ml.
~Drug Information: Sargramostim (Leukine) Formulation: 250 mcg, 500 mcg lyophlized powder for injection"
12046807|NCT00228696|Other|none, screening only|Screening protocol with no intervention
12046808|NCT00228683|Procedure|Biology Study and Tissue Banking|Collection of specimens from Hepatoblastoma patients.
12046809|NCT00228657|Drug|4% Albumin / 0.9% Sodium Chloride|
12046810|NCT00228605|Drug|OraVescent Fentanyl|
12046811|NCT00228592|Drug|HepeX-B|
12046812|NCT00228592|Drug|Hepatitis B Immune Globulin (HBIg)|
12046813|NCT00228566|Drug|Armodafinil|
12046814|NCT00228553|Drug|Armodafinil 100 to 250 mg/day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).
12046815|NCT00228540|Drug|Modafinil|
12046816|NCT00228527|Drug|Esomeprazole (Nexium)|
12046817|NCT00228514|Drug|Rosuvastatin|
12046818|NCT00228514|Procedure|Positron emission tomography|
12046819|NCT00228488|Drug|Gefitinib|
12046820|NCT00228475|Drug|Pulmicort (budesonide) Turbuhaler|
12046821|NCT00228462|Drug|Seroquel (quetiapine)|
12046822|NCT00228449|Drug|peginesatide|
12046823|NCT00228436|Drug|peginesatide|
12046824|NCT00228423|Drug|Clopidogrel 75 mg daily|Daily dose of 75 mg Clopidogrel
12046825|NCT00228423|Drug|water pill daily|Daily dose of water pill (placebo)
12046826|NCT00228410|Drug|Tigecycline|
12046827|NCT00228410|Drug|vancomycin with aztreonam|
12046828|NCT00228397|Drug|CCI-779|
12046829|NCT00228384|Device|GORE VIABAHN Endoprosthesis|Implantation
12046830|NCT00228384|Device|Bare Nitinol Stent|Implantation
12046831|NCT00228371|Device|Neurostimulation|High frequency neurostimulation of subthalamic nucleus : quadrupolar electrode, type 3389, n° : I7 02 08 39709 158, Medtronic, Minneapolis, USA
12046832|NCT00228358|Drug|ex vivo-expanded HER2-specific T cells|Laboratory-expanded T cells, given IV
12046833|NCT00228358|Drug|cyclophosphamide|Given IV
12046834|NCT00228358|Biological|denileukin diftitox|Given IV
12046835|NCT00228358|Other|flow cytometry|Intracellular cytokine staining (correlative study)
12046836|NCT00228358|Other|immunoenzyme technique|ELIspot assay (correlative study)
12046837|NCT00228345|Procedure|Optical coherence tomography,Fluorescein angiography|
12046838|NCT00228332|Drug|Administration of zinkgluconaat or placebo|
12046839|NCT00228319|Dietary Supplement|Oral Ascorbic Acid|4 grams per day for 12 months
12046840|NCT00228319|Drug|Paclitaxel|Six cycles
12046841|NCT00228319|Drug|Carboplatin|Six cycles
12046842|NCT00228319|Drug|Sodium Ascorbate|Intravenous infusion at 0.5 gram/min twice weekly over 1-2 hours at a dose to achieve levels of 400 mg/dl for 12 months
12046843|NCT00228319|Dietary Supplement|Oral Mixed natural Carotenoids with Vitamin A|Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
12046844|NCT00228319|Dietary Supplement|Vitamin E|500 IU per capsule and participant to take 1 capsule daily for 12 months
12046845|NCT00228306|Behavioral|Rehabilitation exercise|Rehab therapy is delivered for 8 weeks.
12046846|NCT00228293|Device|investigational monitor/defibrillator with CPR feedback|
12046847|NCT00228280|Procedure|Mineral Trioxide Aggregate (MTA)|retrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha
12046848|NCT00228267|Drug|Propofol|
12046849|NCT00228254|Drug|Zinc (12.5 mg/day)|
12046850|NCT00228254|Drug|vitamin A 10,000 IU per week|
12046851|NCT00228241|Device|AAI vs. DDD vs. BIV pacing in different patients groups|
12046852|NCT00228228|Biological|T cell vaccination|
12046853|NCT00228215|Behavioral|TIPS Intervention|A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
12046854|NCT00228189|Biological|CEA-loaded dendritic cell vaccine|Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells.
12046855|NCT00228176|Drug|Rimonabant|Tablet, oral administration
12046856|NCT00228176|Drug|Placebo (for Rimonabant)|Tablet, oral administration
12046857|NCT00228163|Drug|teriflunomide (HMR1726)|tablet, oral administration once daily.
12046858|NCT00228150|Drug|SR57667B|
12046859|NCT00228098|Behavioral|Smoking cessation|
12046860|NCT00228072|Procedure|Suction-curettage|
12046861|NCT00228059|Drug|Licarbazepine|
12046862|NCT00228046|Drug|Divalproex Sodium|
12046863|NCT00228046|Drug|Methylphenidate|
12046864|NCT00228046|Drug|Dextroamphetamine|
12046865|NCT00228046|Drug|Mixed Amphetamine Salts|
12046866|NCT00228046|Behavioral|Family Counseling|
12046867|NCT00228046|Behavioral|Behavior Management Training with Parents|
12046868|NCT00228033|Drug|Elemental calcium (as carbonate)|
12046869|NCT00228020|Drug|basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)|
12046870|NCT00228020|Drug|MMF, cyclosporine, steroids|
12046871|NCT00228007|Drug|Antidepressant Medication|
12046872|NCT00227994|Drug|Galantamine|Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.
12046873|NCT00227994|Drug|Donepezil|Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
12046874|NCT00227981|Behavioral|Interpersonal Psychotherapy|
12046875|NCT00227981|Drug|Fluoxetine|
12046876|NCT00227968|Behavioral|Interpersonal Social Rhythm Therapy (IPSRT)|
12046877|NCT00227968|Behavioral|Clinical Status and Symptom Response Therapy (CSSRT)|
12046878|NCT00227955|Drug|Imipramine|
12046879|NCT00227955|Behavioral|Interpersonal Psychotherapy|
12046880|NCT00227942|Drug|Estrogen Replacement Therapy|17-b-Estradiol Patch, .05 mg/day; applied for 7 days
12046881|NCT00227942|Drug|Zolpidem|10 mg/day, po qhs
12046882|NCT00227942|Drug|placebo|placebo
12046883|NCT00227929|Procedure|Care Management|
12046884|NCT00227916|Behavioral|Behavior Therapy|
12046885|NCT00227903|Behavioral|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
12046886|NCT00227903|Behavioral|Brief Advice|Advice and education
12046887|NCT00227890|Behavioral|MI/CBT|
12046888|NCT00227890|Behavioral|RT/TU|
12046889|NCT00227877|Behavioral|cSBA - New England, USA|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
12046890|NCT00227877|Behavioral|cSBA - Prague, CZR|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
12046891|NCT00227864|Behavioral|Behavior Therapy|
12046892|NCT00227864|Other|Treatment as Usual|
12046893|NCT00227838|Behavioral|Behavior Therapy|
12046894|NCT00227825|Behavioral|Motivational interviewing|
12046895|NCT00227812|Drug|Bupropion|
12046896|NCT00227786|Behavioral|smoking cessation intervention|
12046897|NCT00227786|Other|counseling intervention|
12046898|NCT00227773|Drug|octreotide acetate|
12046899|NCT00227773|Drug|vatalanib|
12046900|NCT00227773|Procedure|anti-cytokine therapy|
12046901|NCT00227773|Procedure|antiangiogenesis therapy|
12046902|NCT00227773|Procedure|biological therapy|
12046903|NCT00227773|Procedure|endocrine therapy|
12046904|NCT00227773|Procedure|enzyme inhibitor therapy|
12046905|NCT00227773|Procedure|growth factor antagonist therapy|
12046906|NCT00227773|Procedure|hormone therapy|
12046907|NCT00227773|Procedure|protein tyrosine kinase inhibitor therapy|
12046908|NCT00227773|Procedure|somatostatin analogue therapy|
12046909|NCT00227760|Drug|Cediranib Maleate|Given PO
12046910|NCT00227760|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Correlative studies
12046911|NCT00227760|Other|Laboratory Biomarker Analysis|Correlative studies
12046912|NCT00227760|Other|Pharmacological Study|Correlative studies
12046913|NCT00227747|Drug|capecitabine|
12046914|NCT00227747|Drug|oxaliplatin|
12046915|NCT00227747|Procedure|conventional surgery|
12046916|NCT00227747|Procedure|neoadjuvant therapy|
12046917|NCT00227747|Radiation|radiation therapy|
12046918|NCT00227734|Drug|capecitabine and oxaliplatin + cetuximab|cetuximab
12046919|NCT00227734|Drug|capecitabine and oxaliplatin|capecitabine and oxaliplatin without cetuximab
12046920|NCT00227721|Drug|Docetaxel|40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
12046921|NCT00227721|Drug|Gemcitabine hydrochloride|800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
12046922|NCT00227708|Drug|docetaxel|
12046923|NCT00227708|Procedure|quality-of-life assessment|
12046924|NCT00227695|Biological|rituximab|comparing two maintenance schedules of Rituximab
12046925|NCT00227682|Dietary Supplement|ascorbic acid|
12046926|NCT00227682|Drug|arsenic trioxide|
12046927|NCT00227682|Drug|dexamethasone|
12046928|NCT00227682|Drug|thalidomide|
12046929|NCT00227669|Drug|docetaxel|
12046930|NCT00227669|Drug|gemcitabine hydrochloride|
12046931|NCT00227656|Biological|PEG-interferon alfa-2a|Once a week subcutaneous injection for 21 days, beginning at 180 mcg per week. Repeated for additional 21 days to begin at the same time as repeat 21 day Capecitabine cycle.
12046932|NCT00227656|Drug|Capecitabine|1000 mg/m^2 twice daily during first 14 days of each 3-week cycle (2 weeks on, 1 week rest).
12046933|NCT00227630|Drug|cisplatin|
12046934|NCT00227630|Drug|pemetrexed disodium|
12046935|NCT00227630|Procedure|adjuvant therapy|
12046936|NCT00227630|Procedure|conventional surgery|
12046937|NCT00227630|Procedure|neoadjuvant therapy|
12046938|NCT00227630|Radiation|radiation therapy|
12046939|NCT00227617|Biological|bevacizumab|5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
12046940|NCT00227617|Drug|5-fluorouracil|2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
12046941|NCT00227617|Drug|leucovorin|200mg/m2 IV q2 wk on day 1 over a 2-hour period.
12046942|NCT00227617|Drug|oxaliplatin|200mg/m2 IV q 2 wk on day 1 over a 2-hour period
12046943|NCT00227591|Drug|lenalidomide|Given orally (PO)
12046944|NCT00227591|Drug|prednisone|Given PO
12046945|NCT00227591|Other|laboratory biomarker analysis|Correlative studies
12046946|NCT00227565|Drug|carboplatin|
12046950|NCT00227539|Drug|pemetrexed disodium|
12046951|NCT00227539|Procedure|adjuvant therapy|
12046952|NCT00227539|Procedure|therapeutic conventional surgery|
12046953|NCT00227539|Radiation|fludeoxyglucose F 18|
12046954|NCT00227526|Behavioral|Prehabilitation|
12046955|NCT00227513|Drug|bortezomib|Given IV
12046956|NCT00227513|Drug|vorinostat|Given orally
12046957|NCT00227500|Drug|Pravastatin|
12046958|NCT00227487|Other|Stool collection|Stool sample will be obtained by parent at home to prevent sample dilution during the cleanout
12046959|NCT00227487|Other|Administration of carbohydrate solution during clinically indicated endoscopy|"A carbohydrate solution (lactulose + rhamnose dissolved in tap water) will be administered during the procedure (upper endoscopy) through a catheter directly into the duodenum to allow for intestinal permeability analysis.
~Clinically indicated pinch biopsies will then be obtained.
~The endoscopy procedures will take at least 1 - 1 ½ hours.
~Children will then typically recover in the endoscopy suite for 2 - 2½ hours or less, if the child is medically cleared to leave the endoscopy suite sooner.
~Urine for intestinal permeability analysis will be collected during 5 hours after carbohydrate solution administration. If the child has not voided, an additional 60 minutes will be allowed for the child to void. If the child is not continent for urine, a bag will be applied to catch the specimen."
12046960|NCT00227487|Other|Questionnaires|Parents/legal guardians of subjects will be asked to complete five (5) questionnaires: the Gastrointestinal Symptoms Inventory; a Developmental Screening for Autism - based on the child's age, either the Checklist for Autism in Toddlers (CHAT), Modified Checklist for Autism in Toddlers (M-CHAT), or the Social Communication Questionnaire (SCQ); the Behavior and Sensory Interest Questionnaire (BSI), the Behavior Problems Inventory (BPI), and the Aberrant Behavior Checklist (ABC). It should take parents/guardians no longer than eighty-five (85) minutes to complete all 5 surveys. Results from these questionnaires will be correlated with documented gastrointestinal and/or neurological diagnostic information from subject medical records and with research study test results.
12046961|NCT00227474|Drug|recombinant modified vaccinia Ankara-5T4 vaccine|
12046962|NCT00227474|Procedure|adjuvant therapy|
12046963|NCT00227474|Procedure|recombinant viral vaccine therapy|
12046964|NCT00227461|Drug|Wait first, then levetiracetam|Levetiracetam 250 mg orally twice daily for 7 days. This will increase to 500 mg oral twice daily for 7 days the following week. If this dose is tolerated, it will then be increased to 750 mg orally twice daily for another 7 days and then increased to 1000 mg orally twice daily for 7 days.
12046965|NCT00227461|Drug|Levetiracetam first, then wait|subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design
12046966|NCT00227448|Drug|intravenous saline|
12046967|NCT00227448|Drug|intravenous phenylephrine|
12046968|NCT00227448|Drug|intravenous levophed|
12046969|NCT00227448|Drug|oral midodrine|
12046970|NCT00227435|Drug|val-mCyd|
12046971|NCT00227422|Biological|Mencevax ACWY|
12046972|NCT00227409|Drug|calcium disodium EDTA (edetate calcium disodium)|
12046973|NCT00227383|Device|Electroacupuncture (device)|
12046974|NCT00227370|Drug|valganciclovir|valgan 900mg QD x 9 months post lung transplant
12046975|NCT00227370|Other|Placebo|
12046976|NCT00227357|Drug|On-site - buprenorphine/naloxone (Suboxone)|Tablet, sub-lingual, 8/2 mg, 1-3 daily
12046977|NCT00227357|Drug|Off-site - methadone or no agonist|
12046978|NCT00227344|Device|RF ablation|Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System
12046979|NCT00227344|Drug|Antiarrhythmic drugs|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
12046980|NCT00227331|Drug|Oral amoxicillin|
12046981|NCT00227318|Drug|ATACAND|
12046982|NCT00227305|Drug|quetiapine fumarate|Oral dosing, flexible dosing
12046983|NCT00227292|Drug|Escitalopram|Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
12046984|NCT00227292|Drug|Placebo|Placebo 10mg per day for the first week, then 20mg per day till the end of study.
12046985|NCT00227279|Biological|ALK Grass tablet|Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
12046986|NCT00227266|Drug|Valproic Acid and Levocarnitine|VPA,sprinkle cap; Levocarnitine, syrup; dosage is by weight
12046987|NCT00227266|Drug|Placebo|
12046988|NCT00227253|Procedure|Determination of growth hormone status|Growth hormone stimulating testing using Arginine and Clonidine, Corticotrophin releasing hormone stimulation test
12046989|NCT00227253|Procedure|Measurement of growth, thyroid and sex hormone levels|Gonadotrophin releasing hormone stimulation test Thyroid testing - T4, TSH, T3 uptake, and anti-thyroidal antibodies baseline sample - no medication administered
12046990|NCT00227253|Procedure|Behavior and neuropsychometric evaluations|evaluation by neuropsychologist, standardized testing geared to study participant's age, abilities and past medical history
12046991|NCT00227253|Procedure|Audiological and ear, nose and throat examination|neurotological exam, behavioral audiometry, immittance audiometry, assessment of the function of the inner ear using otoacoustic emissions, Auditory brain responses
12046992|NCT00227253|Procedure|Magnetic resonance imaging of the brain|MRI of the brain - standard clinical procedure
12046993|NCT00227253|Procedure|Dysmorphology evaluation|Genetic evaluation with picture and measurements, physical exam
12046994|NCT00227253|Procedure|Neurology examination|physical examination including observation of balance, coordination and reflexes.
12046995|NCT00227253|Procedure|Dental evaluation|Visual detal inspection with panorex X-ray of the entire mouth
12046996|NCT00227253|Procedure|Speech pathology evaluation|Standardized speech & language tests and naturalistic assessment procedures.
12046997|NCT00227253|Procedure|Psychiatric evaluation|Psychiatric interview about history of psychiatric and medical illnesses, family psychiatric and medical history, demographic info also obtained
12046998|NCT00227253|Procedure|Orthopedic evaluation|Physical exam by orthopedic surgeon and a dysplasia series of radiographs including AP and lateral radiographics of the feet, APs of the knees, pelvis, thoracic lumbar spine and chest, laterals of thoracic lumbar and cervical spine, lateral of the skull, AP and lateral of the forearm, bone age evaluation with radiograph of left hand
12047362|NCT00224016|Drug|Oxybutynin|1.3, 2.6, 3.9 mg/day transdermal
12046999|NCT00227253|Procedure|Ophthalmologic evaluation|exam will determine visual acuity using one of the following: Snellen chart, Allen acuity, target acuity, optokinetic nystagmus (OKN), or Teller acuity depending on study participants ability level. Motility/alignment will also be determined using cover/uncover test. Pupils examined using slit lamp. Dilated fundus exam and cycloplegic refraction which will require dilating drops in both eyes. Cyclogen 1% and NeuSynephrine 2.5% are using. In children less than 6 months old, less potent mydriatrics and cycloplegics are used Cyclogel 0.5% or Tropicamide 1%. Intraocular pressure will be measured in adults and cooperative teens using applanation tonometry. A topical anesthetic will be used to perform this measurement.
12047000|NCT00227253|Procedure|Gastrointestinal evaluation|physical exam and medical history by board certified gastroenterologist.
12047001|NCT00227201|Behavioral|Self-affirmation intervention|
12047002|NCT00227188|Drug|Pneumococcal 7-valent conjugate vaccine Prevnar|
12047003|NCT00227175|Behavioral|Semi-structured, open ended interview|
12047004|NCT00227162|Behavioral|Group 1|Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.
12047005|NCT00227162|Behavioral|Group 2|Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention.
12047006|NCT00227162|Behavioral|Group 3|Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive both positive affect and self-affirmation intervention.
12047007|NCT00227136|Drug|5-Hydroxy-Tryptamine|
12047008|NCT00227123|Drug|quetiapine, risperidone|Flexible dose titrations to 'treat-to-symptoms'
12047009|NCT00227110|Drug|Pioglitazone|30 mg/d for 8 weeks and titrated to 45 mg/d until completing 6 months of treatment.
12047010|NCT00227110|Drug|Placebo|Placebo is given to match pioglitazone.
12047011|NCT00227097|Behavioral|Education Notebook for anticoagulant treatment|
12047012|NCT00227084|Drug|Arista AH hemostasis powder|
12047013|NCT00227071|Behavioral|exercise|
12047014|NCT00227058|Drug|Orotic acid and Glutathione-(Nutritional Supplements)|
12047015|NCT00227032|Drug|erlotinib hydrochloride|"300 mg, per day for subjects taking EIAEDs
~150 mg, per day for those NOT taking EIAEDs"
12047016|NCT00227019|Drug|Bevacizumab|15 mg/kg, IV over 10 minutes every 3 weeks
12047017|NCT00227019|Drug|Pemetrexed|500 mg/m²; IV over 10 minutes every 3 weeks
12047018|NCT00227019|Drug|Vitamin B12|1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed
12047019|NCT00227019|Drug|Folate|350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose
12047020|NCT00227019|Drug|Dexamethasone|4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed
12047021|NCT00227006|Behavioral|Behavioral lifestyle/weight-loss intervention|
12047022|NCT00226993|Drug|CPG 7909|
12047023|NCT00226980|Drug|Thalidomide|
12047024|NCT00226980|Drug|Capecitabine|
12047025|NCT00226967|Drug|Sandostatin|Calculated per patient
12047026|NCT00226954|Drug|zoledronic acid|
12047027|NCT00226941|Drug|Cetuximab|Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)
12047028|NCT00226941|Drug|Oxaliplatin|Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23.
12047029|NCT00226941|Drug|Capecitabine|Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses
12047030|NCT00226941|Radiation|Radiotherapy|"Radiotherapy is administered on weekdays in 180 centigray fractions (doses), for 28 total fractions delivering a total dose of 5040 centigray (cGy)"
12047031|NCT00226941|Drug|Diphenhydramine hydrochloride (HCl)|Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab
12047032|NCT00226928|Behavioral|Supportive-Expressive Group Therapy plus education|
12047033|NCT00226928|Behavioral|Education|
12047034|NCT00226915|Drug|Paclitaxel+Carboplatin|Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
12047035|NCT00226915|Drug|Paclitaxel+Carboplatin|Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
12047036|NCT00226902|Procedure|Changing hemoglobin concentration|
12047037|NCT00226889|Drug|bosentan|
12047038|NCT00226863|Behavioral|meditation plus education|
12047039|NCT00226863|Behavioral|group psychotherapy with hypnosis plus education|
12047040|NCT00226863|Behavioral|education|
12047041|NCT00226850|Behavioral|hypnosis|
12047042|NCT00226837|Drug|Nitrous oxide|nitrous oxide by inhalation during induction
12047043|NCT00226824|Drug|galantamine|
12047044|NCT00226811|Drug|Sunitinib|50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed
12047045|NCT00226798|Drug|Capecitabine (Xeloda)|
12047046|NCT00226785|Drug|Dexmedetomidine|
12047047|NCT00226772|Drug|OMS103HP|Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
12047048|NCT00226772|Drug|Vehicle|Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
12047049|NCT00226759|Drug|OMS103HP|Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
12047050|NCT00226759|Drug|Vehicle|Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
12047051|NCT00226746|Drug|Paclitaxel and gemcitabine|"Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.
~Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36."
12047052|NCT00226733|Behavioral|Exercise training|Interval exercise training with high intensity five days per week for four weeks.
12047053|NCT00226733|Behavioral|Exercise training|Exercise training with moderate intensity, five days per week for four weeks.
12047054|NCT00226720|Procedure|Outpatient detoxification program|Outpatient detoxification program
12047055|NCT00226707|Drug|Pimecrolimus Cream 1%|
12047425|NCT00223691|Drug|Acarbose|25-100 mg, PO. Single dose.
12047056|NCT00226694|Drug|Citalopram|Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
12047057|NCT00226694|Other|Placebo|Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
12047058|NCT00226681|Behavioral|Nursing Telephone Support Protocol|
12047059|NCT00226681|Behavioral|Usual Care|
12047060|NCT00226668|Drug|hCRF|hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
12047061|NCT00226668|Drug|placebo hCRF|placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
12047062|NCT00226655|Drug|hCRF [XERECEPT (corticorelin acetate injection)]|2mg/day
12047063|NCT00226642|Drug|Sertralin|
12047064|NCT00226642|Behavioral|Cognitive-behavioral therapy|
12047065|NCT00226642|Drug|Placebo|
12047066|NCT00226642|Behavioral|Non-specific supporting group therapy|
12047067|NCT00226629|Procedure|Endovascular vs Open Repair|
12047068|NCT00226616|Drug|Zinc|
12047069|NCT00226603|Behavioral|Specific training programme (behavior)|
12047070|NCT00226590|Drug|Gemcitabine|Induction Chemotherapy.
12047071|NCT00226590|Drug|Carboplatin|Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.
12047072|NCT00226590|Drug|Paclitaxel|Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.
12047073|NCT00226590|Procedure|Radiation|Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.
12047074|NCT00226577|Drug|Gemcitabine|Gemcitabine (GemzarR) 1500 mg/m2
12047075|NCT00226577|Drug|Pemetrexed|Pemetrexed (AlimtaR) 500 mg/m2
12047076|NCT00226577|Procedure|Surgery|When the chemotherapy treatment is completed, the patient's tumor response will be evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). If there is no growth or spread of the cancer on any of these tests, patients will then proceed to have surgery by week 10 to remove the cancer.
12047077|NCT00226564|Drug|Alfentanil|
12047078|NCT00226551|Drug|Isoproterenol|
12047079|NCT00226538|Drug|Phenytoin|
12047080|NCT00226538|Drug|Rifampicin|
12047081|NCT00226538|Drug|Diclophenac|
12047082|NCT00226538|Drug|Fluconazole|
12047083|NCT00226525|Procedure|skin sensitivity test|
12047084|NCT00226512|Drug|Campath-1H /ATG|
12047085|NCT00226499|Biological|Priorix-tetra™|2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group
12047086|NCT00226499|Biological|Priorix™|2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group
12047087|NCT00226499|Biological|Varilrix™|1 dose administered subcutaneously at Day 42 to subjects in OKAH Group
12047088|NCT00226486|Other|multifactorial intervention|Identification of medical, cardiovascular, physical risk factors for falls; e.g. vision, drug-use, depression, carotid sinus syndrome, orthostatic hypotension, etc. Individual intervention; treatment of disease, drug review, pacemaker, exercises, new glasses, all if indicated.
12047089|NCT00226486|Other|Usual care|No intervention, but ususal care after an accidental fall.
12047090|NCT00226473|Drug|Cisplatin, Vindesine, Dacarbazine (drugs)|
12047091|NCT00226460|Drug|Fetal porcine cells, Neurocell-PD|
12047092|NCT00226447|Drug|Pegylated Interferon|
12047093|NCT00226447|Drug|Lamivudine|
12047094|NCT00226434|Procedure|Early antiretroviral treatment|The ARV treatment is started 2 weeks after the diagnosis and the start of the anti-tuberculosis treatment
12047095|NCT00226434|Procedure|Late antiretroviral treatment|The ARV treatment is started 8 weeks after the diagnosis and the start of the anti-tuberculosis treatment
12047096|NCT00226421|Drug|Oxymorphone Extended Release|
12047097|NCT00226408|Drug|Interferon-alpha-2b|
12047098|NCT00226395|Drug|Oxymorphone immediate release|
12047099|NCT00226382|Drug|Pegylated Interferon-alfa-2a|Pegasys once weekly
12047100|NCT00226369|Drug|CY-1503|
12047101|NCT00226356|Drug|Supplements of L-methionine, betaine and folate|
12047102|NCT00226343|Drug|Depakote-ER|
12047103|NCT00226330|Drug|Tesaglitazar|(0.5 or 1 mg)
12047104|NCT00226330|Drug|Pioglitazone|(15, 30 or 45 mg)
12047105|NCT00226317|Drug|Aripiprazole|
12047106|NCT00226291|Other|Synthesized evidence report|Each consultation response included a documented bibliographic search strategy with corresponding references, a targeted list of full-text articles, and a written synthesis and critique of the relevant research materials.
12047107|NCT00226278|Drug|ORG 34517|
12047108|NCT00226252|Procedure|Instruction Only|Video details an individual propelling a manual wheelchair with biomechanically correct propulsion technique.
12047109|NCT00226252|Procedure|Instruction and Feedback|Individuals will watch video of correct propulsion technique and will receive real-time feedback from the SMART Wheel as they push their wheelchair to help optimize their propulsion technique.
12047110|NCT00226239|Drug|Docetaxel|Docetaxel 75 mg/m^2 IV over 1 hour, day 1
12047111|NCT00226239|Drug|Cisplatin|Cisplatin 75 mg/m^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
12047112|NCT00226239|Drug|Cetuximab|Cetuximab dose will be 250 mg/m^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
12047113|NCT00226239|Procedure|Radiation Therapy|Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies>6 MV may be utilized when appropriate to boost target localized centrally.
12047114|NCT00226226|Procedure|Peripherally Inserted Central Catheter Placement|
12047115|NCT00226213|Procedure|Peripherally Inserted Central Catheter Placement|
12047116|NCT00226200|Drug|Omalizumab|
12047117|NCT00226187|Procedure|Supplement of fatty acid (DHA and AA)|
12047118|NCT00226174|Drug|Curcuminoids|
12047119|NCT00226161|Procedure|Inguinal herniorrhaphy|
12047120|NCT00226148|Procedure|Use of a membrane to cover bonedefects around implant|
12047121|NCT00226148|Device|Use of bonechips to fill up defects around implant|
12047122|NCT00226148|Procedure|Use of membrane and bonechips to manage defects|
12047123|NCT00226135|Drug|lithium or lamotrigine|
12047124|NCT00226122|Drug|Indomethacin|Indomethacin capsules 50 mg
12047125|NCT00226109|Drug|spironolactone|100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
12047126|NCT00226096|Drug|Labetalol Hydrochloride|
12047127|NCT00226096|Drug|Metoprolol tartrate|
12047128|NCT00226096|Drug|Hydralazine Hydrochloride|
12047129|NCT00226096|Drug|Glycerol Trinitrate|
12047130|NCT00226096|Drug|Phentolamine mesylate|
12047131|NCT00226096|Drug|Nicardipine|
12047132|NCT00226096|Drug|Urapidil|
12047133|NCT00226096|Drug|Esmolol|
12047134|NCT00226096|Drug|Clonidine|
12047135|NCT00226096|Drug|Enalaprilat|
12047136|NCT00226096|Drug|Nitroprusside|
12047137|NCT00226070|Procedure|interview and advising|
12047138|NCT00226070|Behavioral|3 follow up interviews and personal advising|
12047139|NCT00226070|Procedure|interview SF-36 self rated health|
12047140|NCT00226057|Drug|Raptiva|Open Label
12047141|NCT00226044|Drug|Omeprazole rectally 1mg/kg|A single dose of 1 mg/kg rectally administered omeprazole.
12047142|NCT00226031|Procedure|Educational Material and Reminder|Family practices were randomly assigned to intervention or usual care. The intervention was a mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the GP and a letter and educational package for the women.
12047143|NCT00226018|Device|Hand Adapter (Organon, Oss, the Netherlands)|Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring)
12047144|NCT00226018|Device|Placebo|placebo
12047145|NCT00226005|Drug|PTK787/ZK222584|One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
12047146|NCT00225992|Drug|Arsenic Trioxide|
12047147|NCT00225979|Drug|Octreotide LAR|
12047148|NCT00225966|Device|Device Medtronic InterStim Tined Leads Models 3889 and 3093|
12047149|NCT00225927|Procedure|radioguided seed localization for nonpalpable breast cancers|radio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery
12047150|NCT00225914|Drug|Paroxetine|Paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability
12047151|NCT00225914|Drug|placebo|Subjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability.
12047152|NCT00225901|Drug|Recombinant human hepatocyte growth factor|
12047153|NCT00225888|Behavioral|Digital Photography of meals/snacks and group discussion|Digital Photography of meals/snacks and group discussion
12047154|NCT00225875|Drug|Mabthéra|
12047155|NCT00225862|Drug|ropinirole|
12047156|NCT00225849|Drug|Aspirin|
12047157|NCT00225836|Device|OVA (TENS apparatus)|
12047158|NCT00225823|Drug|GW685698X|
12047159|NCT00225810|Drug|Crohn's Disease|
12047160|NCT00225797|Drug|Oxymorphone Extended Release|
12047161|NCT00225784|Drug|Cetuximab/Gemcitabine|Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
12047162|NCT00225784|Procedure|Radiotherapy|Daily radiotherapy for 28 days
12047163|NCT00225758|Drug|Lapatinib|1500 mg po daily for 26 weeks or longer
12047164|NCT00225745|Procedure|Blood draw|One blood draw prior to first treatment
12047165|NCT00225732|Other|Normal saline as placebo comparator|250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)
12047166|NCT00225732|Drug|Intravenous ibuprofen|"800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours.
~Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)"
12047167|NCT00225719|Drug|rHDL|
12047168|NCT00225706|Drug|Caldolor|
12047169|NCT00225693|Device|drug eluting coronary stent|
12047170|NCT00225680|Device|drug eluting coronary stent|
12047171|NCT00225667|Drug|Irbesartan|
12047172|NCT00225654|Device|coronary stent|
12047173|NCT00225641|Procedure|CT-scan, CEA, X-ray of lungs|Arm 1: 6, 12, 18, 24 and 36 months after surgery
12047174|NCT00225641|Procedure|CT-scan, CEA, X-ray of lungs|Arm 2: 12 and 36 months after surgery
12047175|NCT00225628|Behavioral|Computerized Reminders Medications Monitoring|
12047176|NCT00225628|Behavioral|Computerized Test Results Management Application|
12047177|NCT00225628|Behavioral|Computerized Reminders Hypertension Management|
12047178|NCT00225628|Behavioral|Computerized Reminders Osteoporosis Screening and Mgt|
12047179|NCT00225615|Drug|sapropterin dihydrochloride|
12047180|NCT00225602|Behavioral|Assertive Community Treatment|
12047181|NCT00225602|Behavioral|Treatment in Community Mental Health Center|
12047182|NCT00225589|Drug|Rosuvastatin calcium|
12047183|NCT00225576|Other|Electronic Health Record Implementation|Intervention subjects implemented electronic prescribing as part of an electronic health record implementation
12047184|NCT00225563|Device|Electronic Health Record|e-prescribing methods
12047185|NCT00225550|Drug|ADH -1 (Exherin™)|
12047186|NCT00225537|Drug|4-Methylumbelliferone (Heparvit®)|
12047187|NCT00225524|Drug|Effexor XR|
12047188|NCT00225511|Drug|Effexor XR|
12047189|NCT00225511|Drug|Milnacipran|
12047190|NCT00225498|Drug|ziprasidone vs risperidone or olanzapine|ziprasidone target dose is 160 mg/day risperidone target dose is 4 mg/day olanzapine target dose is 20 mg/day
12047191|NCT00225485|Drug|Effexor XR|
12047192|NCT00225472|Device|Modified Viaspan|
12047193|NCT00225446|Device|MicronTracker|MicronTracker is a Third Generation Optic Repositioning System in orthognatic surgery.
12047194|NCT00225433|Drug|follitropin beta|Follitropin beta
12047195|NCT00225433|Drug|ganirelix acetate|Ganirelix acetate
12047196|NCT00225420|Drug|docetaxel|Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
12047197|NCT00225420|Drug|leuprolide acetate|Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
12047198|NCT00225420|Radiation|radiation therapy|The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.
12047199|NCT00225407|Drug|Smoking of cannabis cigarettes (different strength)|
12047200|NCT00225381|Device|connection of measuring device to anesthesia circuit|same as name
12047201|NCT00225381|Procedure|drawing of blood sample through an arterial line, placed according to clinical criteria by primary anesthesia team|same
12047202|NCT00225381|Procedure|changing operating room bed position (head down and up position)|same
12047203|NCT00225381|Procedure|adding PEEP during anesthesia|same
12047204|NCT00225381|Procedure|placement of esophageal Doppler for cardiac output measurements|same
12047205|NCT00225381|Device|Humidity sensor|Small conventional anesthesia T piece including tiny 2 thermometer inside
12047206|NCT00225381|Device|A mixing chamber (bymixer)|2 mixing chambers (bymixers) composed of 2 arms where one arm serves as a mixing (passive) arm for the measurement of mixed gas fraction. The bymixer is made of conventional anesthesia supplies and does not influence dead space nor circuit resistance.
12047207|NCT00225381|Device|Pneumotachometer cuvette|The pneumotachometer cuvette is used by many anesthesia monitors to measure gas flow.
12047208|NCT00225381|Device|Mass spectrometer sampling port|Designed for the anesthesia tubing and connected at the airway opening. it has small volume (3 mL) and do not influence circuit resistance.
12047209|NCT00225368|Device|Insecticide treated bednets|
12047210|NCT00225355|Drug|Rosiglitazone|
12047211|NCT00225342|Drug|Rosiglitazone|
12047212|NCT00225342|Drug|Gliclazide (Comparison drug)|
12047213|NCT00225329|Procedure|Labour assessment and support|
12047214|NCT00225316|Procedure|Acupuncture|See Detailed Description.
12047215|NCT00225303|Drug|TMC125|
12047216|NCT00225290|Drug|Thalidomide(Thado)|
12047217|NCT00225277|Drug|Pioglitazone|Up to 45 mg pioglitazone (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.
12047218|NCT00225277|Drug|Glimepiride|Up to 4 mg of glimepiride (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.
12047219|NCT00225264|Drug|Pioglitazone|Pioglitazone 15 mg titrated up to 45 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily for up to 72 weeks.
12047220|NCT00225264|Drug|Glimepiride|Pioglitazone placebo-matching tablets, orally, once daily and glimepiride 1 mg titrated up to 4 mg, capsules, orally, once daily for up to 72 weeks.
12047221|NCT00225251|Drug|bupropion XL|Antidepressant medication
12047222|NCT00225251|Other|Placebo|Placebo
12047223|NCT00225238|Drug|esomeprazole (PPI)|
12047224|NCT00225225|Drug|Rosiglitazone|
12047225|NCT00225225|Behavioral|dietary recommendation for weight maintenance|
12047226|NCT00225212|Drug|Rituximab 375 mg/m2|
12047227|NCT00225199|Drug|Visanne (BAY86-5258, SH T00660AA)|orally once daily
12047228|NCT00225199|Drug|Placebo|orally once daily
12047229|NCT00225186|Drug|Visanne (SH T00660AA , BAY86-5258)|Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
12047230|NCT00225173|Drug|Doxorubicin|Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
12047231|NCT00225173|Drug|Vinblastine|Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
12047232|NCT00225173|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
12047233|NCT00225173|Drug|Etoposide|Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
12047234|NCT00225173|Drug|Vincristine|Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
12047235|NCT00225173|Drug|Bleomycin|Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
12047236|NCT00225173|Drug|Gemcitabine|Gemcitabine 1250 mg/m2 IV w 13,15,17,19
12047237|NCT00225173|Drug|Vinorelbine|Vinorelbine 25 mg/m2 IV w 13,15,17,19
12047238|NCT00225173|Drug|Prednisone|Prednisone 40 mg/m2 PO qod w 1-10, taper
12047239|NCT00225160|Drug|acetyl L-carnitine|
12047240|NCT00225147|Drug|Recombinant Human C1 Inhibitor|IV
12047241|NCT00225147|Drug|placebo|saline solution
12047242|NCT00225121|Drug|PF-00299804|investigational drug by oral route (escalating doses depending on safety) administered until progression
12047243|NCT00225108|Drug|Tinzaparin|
12047244|NCT00225095|Drug|Mesenchymal Stem Cells|
12047245|NCT00225095|Drug|Hyaluronan|
12047246|NCT00225082|Drug|Nucleoside analogue switch|stavudine switched to tenofovir
12047247|NCT00225069|Procedure|Level of sympathectomy|T2 sympathectomy or T2-T3 sympathectomy
12047248|NCT00225056|Drug|docetaxel and capecitabine|
12047249|NCT00225043|Drug|Epinephrine/phenylephrine|
12047250|NCT00225030|Drug|antihypertensive drugs according to current guidelines|
12047251|NCT00225017|Drug|Atazanavir|atazanavir 400 mg once daily
12047252|NCT00225017|Drug|current antiretroviral regimen|Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs
12047253|NCT00225004|Procedure|DEXA scan|orto
12047254|NCT00224991|Procedure|Intensive systematic information (osteoporosis school)|
12047255|NCT00224978|Drug|Chloroquine|
12047256|NCT00224965|Behavioral|Behavior Therapy|
12047257|NCT00224952|Other|No intervention; Urine Collection|Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management
12047258|NCT00224939|Drug|Potassium Chloride|
12047259|NCT00224926|Procedure|Scalp Brushing|sterile, soft-head toothbrush massaged on scalp
12047260|NCT00224913|Procedure|Neuromuscular electrical stimulation|
12047261|NCT00224913|Procedure|Voluntary exercise|
12047262|NCT00224887|Behavioral|In home nutrition counseling|
12047263|NCT00224874|Drug|Etanercept|Etanercept [25 mg subcutaneously twice weekly for up to 4 weeks; discontinue if in complete response by 4 weeks].
12047264|NCT00224874|Drug|Mycophenolate Mofetil|Mycophenolate mofetil (MMF) [20 mg/kg (maximum 1 gm) orally or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks].
12047265|NCT00224874|Drug|Denileukin Diftitox|Denileukin Diftitox (ONTAK®) [9 mcg/kg intravenously Days 1, 3, 5, 15, 17, 19].
12047266|NCT00224874|Drug|Pentostatin|Pentostatin [1.5 mg/m2 daily for 3 days; Days 1-3 and repeat Days 15-17
12047267|NCT00224861|Behavioral|Self-Management|
12047268|NCT00224861|Behavioral|Adherence|
12047269|NCT00224848|Behavioral|Palm-Pilot Intervention|"Both groups received guideline dissemination, patient activation materials, continuing education (CE) and feedback based on baseline chart audit. The intervention included academic detailing (AD) and a hand-held computerized decision support tool that provided patient-specific, ATPIII-based risk stratification and treatment recommendations. CE sessions offered information relevant to ATPIII and JNC7 and focused on the evidence base. AD offerings focused on strategies to apply concepts to practice and were specific to the randomized arm. Investigators visited each practice at baseline to educate physicians about the guideline and evidence supporting prevention of CVD, and to provide training on use of the Palm tool. Visits were conducted as lunch and learn sessions. The tool was a modified version of NHLBI's PDA decision support program and indicates specific drug therapies and dosages needed to achieve cholesterol reduction and prints documentation. A user's manual was developed."
12047270|NCT00224835|Behavioral|Mindfulness Based Stress Reduction Class|Subjects randomized to this condition will attend 120 minute weekly sessions, plus a 7 hour retreat, for training in mindfulness meditation methods.
12047271|NCT00224835|Behavioral|Cardiac Education Class|"Subjects in the disease education control condition will attend 8 weekly 60 minute sessions, plus a 7 hour special experience session, all of which will provide information about CAD in a didactic format."
12047272|NCT00224822|Drug|Aripiprazole|
12047273|NCT00224809|Drug|Angiotensin-Converting Enzyme Inhibitors|
12047274|NCT00224809|Procedure|Coronary Artery Bypass Graft|
12047275|NCT00224809|Drug|Angiotensin Receptor Blockers|
12047276|NCT00224809|Drug|Spironolactone|
12047277|NCT00224809|Drug|Aspirin|
12047278|NCT00224809|Drug|Clopidogrel|
12047279|NCT00224809|Procedure|Surgical Ventricular Restoration|
12047280|NCT00224796|Device|V.A.C. ® System|
12047281|NCT00224783|Biological|CAIV-T|Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T)
12047282|NCT00224783|Biological|Placebo|0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).
12047283|NCT00224770|Drug|MIS+Cathflo Activase (drug)|MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
12047284|NCT00224770|Procedure|Intraoperative stereotactic CT-Guided Endoscopic Surgery|Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.
12047285|NCT00224757|Procedure|Transoesophageal echocardiography|TEE
12047286|NCT00224744|Device|ultracision|Surgery by Ultracision
12047287|NCT00224744|Device|classical lymphadenectomy|classical lymphadenectomy
12047288|NCT00224718|Procedure|Endovascular repair (with endograft)|An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm. Over time, blood pressure and other factors can cause this weak area to bulge like a balloon and eventually enlarge and rupture. The stent graft seals tightly with your artery above and below the aneurysm. The graft is stronger than the weakened artery and allows blood to pass through it without pushing on the bulge. Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms (AAAs).
12047289|NCT00224718|Procedure|Open repair|Conventional repair consist in open repair. Different types of surgery can be done : minimal incision aortic surgery (MIAS), transperitoneal approach (TPA), retroperitoneal repair, or conventional median laparotomy.
12047290|NCT00224705|Device|Molecular Adsorbent Recirculating System (MARS®)|
12047291|NCT00224692|Drug|Low dose ketamine|
12047292|NCT00224679|Drug|Aspirin|
12047293|NCT00224666|Device|Cortex stimulation|
12047294|NCT00224653|Procedure|Mechanical Ventilation|
12047295|NCT00224640|Drug|Iron chelating intervention|Iron chelating intervention
12047296|NCT00224627|Procedure|Capsule GIVEN IMAGING LTD|
12047297|NCT00224614|Procedure|Allogenic transplantation|
12047298|NCT00224601|Procedure|Colonoscopy with chromoscopy|
12047299|NCT00224588|Drug|Ketamine (or placebo : isotonic saline solution)|
12047300|NCT00224575|Other|diagnosis reassessment|Strategy of diagnosis reassessment following a decision tree.
12047301|NCT00224575|Other|Diagnosis strategy and subsequent therapeutic reassessment|Performed by geriatricians, following a decision tree, based on medical history, electrocardiogram, cardiac echotomography and stress scintigraphy
12047302|NCT00224562|Drug|TNF-alpha antagonists|
12047303|NCT00224549|Drug|irbesartan, amlodipine and hydrochlorothiazide|irbesartan, amlodipine and hydrochlorothiazide
12047304|NCT00224536|Procedure|Intracoronary bone marrow cell transfer|
12047305|NCT00224523|Drug|GW685698X|
12047306|NCT00224523|Drug|mometasone furoate|
12047307|NCT00224510|Drug|lamotrigine|
12047308|NCT00224497|Drug|SB-742457|
12047309|NCT00224484|Biological|GSK208141|3 intramuscular doses
12047310|NCT00224484|Biological|Havrix (investigational formulation)|3 intramuscular doses
12047311|NCT00224484|Biological|Placebo|3 intramuscular doses
12047312|NCT00224471|Biological|GSK208141 vaccine|3 IM doses
12047313|NCT00224458|Drug|Truvada|
12047314|NCT00224458|Drug|efavirenz|
12047315|NCT00224445|Drug|Truvada|Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablet) administered orally once daily (QD)
12047316|NCT00224445|Drug|Atazanavir|Atazanavir 300 mg (given as two 150-mg capsules) administered orally QD
12047317|NCT00224445|Drug|Ritonavir|Ritonavir 100 mg capsule administered orally QD
12047318|NCT00224432|Drug|probiotics: Lactobacillus GG, lactobacillus Rhamnosus|
12047319|NCT00224419|Behavioral|Motivational interviewing for smoking cessation|All participants received a tailored CBT (TCBT) intervention that included: a written self-help guide, info about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. Women in the TCBT + NRT arm were guided through a process of deciding on nicotine gum, lozenge or patch. To minimize fetal exposure, the dose of NRT was customized to the woman's current level of smoking. Women who smoked 5-10 cigarettes a day were given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smoked per day. Those who smoked 11 cigarettes or more per day were given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smoked per day, not to exceed 15 lozenges or pieces of gum per day.
12047320|NCT00224419|Behavioral|Cognitive behaviors therapy|6 counseling sessions delivered over the phone or in person
12047321|NCT00224419|Drug|CBT + NRT|Includes CBT from arm 1 plus choice of NRT (lozenge, gum, or patch) tailored to smoking amount
12047322|NCT00224406|Drug|repertaxin|
12047323|NCT00224393|Drug|Enbrel|
12047324|NCT00224380|Behavioral|Using Medications Effectively|
12047325|NCT00224367|Behavioral|time to first ambulation|
12047326|NCT00224354|Biological|IL-2 secreting and hCL4OL-expressing autologous B-CLL cells|Patients will be treated with six subcutaneous injections of their IL-2-secreting and hCD40L-expressing autologous B-CLL cells, separated by one to two weeks in an immunological treatment window
12047327|NCT00224354|Biological|IL-2|subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).
12047328|NCT00224354|Biological|CD40L|subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).
12047329|NCT00224354|Drug|ONTAK|an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK
12047330|NCT00224354|Biological|immunotoxin dose|Days 0, 2, and 4 (18 ug/kg) i.v
12047331|NCT00280839|Drug|Topiramate|
12047332|NCT00280839|Drug|Placebo|
12047333|NCT00224341|Device|Pacemaker Vitatron Selection 9000|
12047334|NCT00224341|Device|Pacemaker Vitatron T70|
12047335|NCT00224328|Device|ODISsey Tissue Oximeter|
12047336|NCT00224315|Drug|ziprasidone|
12047337|NCT00224315|Drug|risperidone|
12047338|NCT00224302|Drug|Duloxetine|
12047339|NCT00224289|Drug|Latanoprost 0.005%|Latanoprost 0.005% ophthalmic solution QHS 8 weeks
12047340|NCT00224263|Drug|Lingzhi (Ganoderma)|
12047341|NCT00224250|Procedure|One- versus two-layer hysterotomy closure|
12047342|NCT00224211|Behavioral|Music|
12047343|NCT00224198|Procedure|Lung Disease|Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. In the lavage (washing) procedure, sterile 0.9% saline (5 x 20 ml aliquots in 1 to 3 sites) is instilled into the lung and immediately suctioned back, washing off cells lining the airways.In the brushing procedure, a small cytology brush is passed through the bronchoscope, and a small area of the airway wall is brushed gently to obtain epithelial cells lining the airway. Certain individuals may have bronchial wall biopsy carried out. In this procedure, a small biopsy forceps is passed through the bronchoscope and a small biopsy is obtained from the bronchial wall.
12047344|NCT00224185|Procedure|Bronchopulmonary Lung Lavage|Lung Lavage is a Washing. Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the lavage (washing) procedure, sterile 0.9% saline (5 x 20 ml aliquots in 1 to 3 sites) is instilled into the lung and immediately suctioned back, washing off cells lining the airways. Once the fluid has been collected, the fluid is centrifuged and the cells are collected and counted.
12047345|NCT00224185|Procedure|Bronchial Brushing|Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the brushing procedure, a small cytology brush is passed through the bronchoscope, and a small area of the airway wall is brushed gently (in up to 20 different sites in the large and small airways) to obtain epithelial cells lining the airway. Cells collected by airway brushing will be washed, counted, and evaluated for viability. They will also be studied for differential cell count by standard procedures. Collected airway cells will be used to carry out studies assess expression of various genes and to study viral gene transfer.
12047346|NCT00224185|Procedure|Bronchial Wall Biopsy|This is a safe and widely used investigative method in pulmonary medicine. In this procedure, a small biopsy forceps is passed through the bronchoscope and, under direct vision, a small biopsy (in up to 5 sites) is obtained from the bronchial wall. A biopsy obtains tissue to a depth of 2-3 mm, and includes epithelial and subepithelial tissue.
12047347|NCT00224159|Behavioral|Drug and Dietary behavior|
12047348|NCT00224146|Drug|oxybutynin transdermal delivery system (Oxytrol(r))|
12047349|NCT00224133|Drug|Silodosin|8 mg daily
12047350|NCT00224120|Drug|Silodosin|8 mg daily for 12 weeks
12047351|NCT00224120|Other|Placebo|One capsule daily for 12 weeks
12047352|NCT00224107|Drug|Silodosin|8 mg daily for 12 weeks
12047353|NCT00224107|Other|Placebo|1 capsule daily for 12 weeks
12047354|NCT00224094|Drug|Premarin® (oral) vs. Alora® (transdermal)|
12047355|NCT00224081|Drug|Sodium ferric gluconate,|Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
12047356|NCT00224068|Drug|Sodium ferric gluconate, ferrous sulfate, standard of care|
12047357|NCT00224055|Drug|Sodium Ferric Gluconate Complex in Sucrose Injection|Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
12047358|NCT00224055|Drug|Ferrous sulfate tablets|ferrous sulfate, 325 mg oral, three times daily for 6 weeks
12047359|NCT00224042|Drug|Sodium Ferric Gluconate complex in sucrose|Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
12047360|NCT00224042|Drug|Ferrous sulfate tablets|ferrous sulfate 325 mg three times daily for 6 weeks
12047361|NCT00224029|Drug|Oxybutynin transdermal system|3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
12047363|NCT00224016|Drug|Oxybutynin|5 to 15 mg/day immediate release or extended release tablets, or syrup
12047364|NCT00224003|Drug|Sodium Ferric Gluconate Complex in Sucrose.|
12047365|NCT00223990|Biological|FMP1/AS02A|FMP1/AS02A candidate malaria vaccine
12047366|NCT00223990|Biological|RabAvert|RabAvert rabies vaccine
12047367|NCT00223977|Drug|Sodium Ferric Gluconate Complex|125 mg weekly x 8 weeks
12047368|NCT00223977|Drug|Sodium Ferric Gluconate Complex|250 mg weekly x 4
12047369|NCT00223977|Drug|Oral Iron|325 mg ferrous sulfate orally three times daily x 8 weeks
12047370|NCT00223964|Drug|Ferrlecit (sodium ferric gluconate complex in sucrose injection)|
12047371|NCT00223951|Drug|R89674 (generic name not yet established)|
12047372|NCT00223938|Drug|Oral Iron|Oral Iron
12047373|NCT00223938|Drug|sodium ferric gluconate|weekly intravenous injection Dose 1
12047374|NCT00223938|Drug|sodium ferric gluconate|weekly intravenous injection Dose 2
12047375|NCT00223925|Drug|Maribavir|
12047376|NCT00223925|Drug|Placebo|
12047377|NCT00223912|Device|ERGYS BikeFunctional Electrical Stimulation Ergometry|A
12047378|NCT00223899|Genetic|VCL-IM01 (encoding IL-2) with Electroporation|IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).
12047379|NCT00223873|Procedure|Penile Vibratory Stimulation|
12047380|NCT00223860|Drug|Human chorionic gonadotropin (hCG)|
12047381|NCT00223860|Drug|Luteinizing hormone releasing hormone (LHRH)|
12047382|NCT00223847|Behavioral|Constraint Induced Language Therapy|
12047383|NCT00223834|Behavioral|single session of Motivational Interviewing|
12047384|NCT00223821|Drug|Oxybutynin chloride, extended-release, individually-titrated|Individually-titrated, extended-release oxybutynin chloride with management of side-effects.
12047385|NCT00223821|Behavioral|Behavior Training|Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
12047386|NCT00223808|Other|Robot-Low|1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
12047387|NCT00223808|Other|Robot-High|2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
12047388|NCT00223808|Other|Control|1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
12047389|NCT00223795|Device|Single point cane|Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.
12047390|NCT00223782|Behavioral|Gait Training with Feedback|
12047391|NCT00223782|Behavioral|Gait Training with no feedback|
12047392|NCT00223769|Drug|Oxandrolone|
12047393|NCT00223756|Other|Low Vision Intervention - Outpatient Training Program|Patients receive LV therapy as outpatients
12047394|NCT00223743|Drug|Zonisamide|study drug initially will taken as one 50-mg tablet a day, then the dose increased by one tablet each two weeks, to no more than 3 tablets (150 mg) taken twice a day.
12047395|NCT00223730|Drug|Citrulline|Oral provision of amino acid citrulline to support impaired urea cycle function during escalated dose chemotherapy for stem cell transplant
12047396|NCT00223730|Drug|Placebo|
12047397|NCT00223717|Drug|Clonidine|0.1-0.2mg po. Single dose.
12047398|NCT00223717|Drug|Nitroglycerin transdermal|0.05-0.2 mg patch. 1 application. Alone or in combination with DDAVP.
12047399|NCT00223717|Drug|Dipyridamole/ Aspirin (Aggrenox)|dipyridamole 200 mg and aspirin 25 mg po. Single dose.
12047400|NCT00223717|Drug|Desmopressin (DDAVP)|0.2 - 0.6mg po. Single dose. Alone or in combination with nitroglycerin transdermal or nifedipine
12047401|NCT00223717|Drug|Sildenafil|25- 100 mg po. Single dose.
12047402|NCT00223717|Drug|Nifedipine|10-30 mg po. Single dose.
12047403|NCT00223717|Drug|Hydralazine|10-50 mg po. Single dose
12047404|NCT00223717|Drug|Hydrochlorothiazide|12.5-100 mg po. Single dose.
12047405|NCT00223717|Drug|Placebo|Po or patch. Single dose.
12047406|NCT00223717|Drug|Bosentan|62.5 -125 mg po. Single dose.
12047407|NCT00223717|Drug|Diltiazem|30-60 mg po. Single dose.
12047408|NCT00223717|Drug|Eplerenone|50-100 mg po. Single dose.
12047409|NCT00223717|Drug|guanfacine|1-3 mg po. Single dose.
12047410|NCT00223717|Dietary Supplement|L-arginine|6-17 g po. Single dose
12047411|NCT00223717|Drug|captopril|25-50 mg PO. Single dose.
12047412|NCT00223717|Drug|carbidopa|25-200 mg PO. Single dose.
12047413|NCT00223717|Drug|losartan|25-200 mg PO. Single dose.
12047414|NCT00223717|Drug|metoprolol tartrate|25-100 mg PO. Single dose.
12047415|NCT00223717|Drug|nebivolol hydrochloride|2.5-40 mg PO. Single dose.
12047416|NCT00223717|Drug|prazosin hydrochloride|0.5-1 mg PO. Single dose.
12047417|NCT00223717|Drug|tamsulosin hydrochloride|0.4-0.8 mg PO. Single dose.
12047418|NCT00223717|Other|Head-up tilt.|Head of the bed elevated 10 degrees (7 inch) or whole bed tilted head-up 5 degrees in reverse trendelenburg (head of the bed elevated 7 inches)
12047419|NCT00223717|Drug|aliskiren|aliskiren (Tekturna) 150-300mg po single dose
12047420|NCT00223717|Other|Local heat stress|Passive heat-stress using a commercial heating pad applied over the abdomen and part of the torso
12047421|NCT00223704|Drug|HOE 140|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
12047422|NCT00223704|Drug|Aminocaproic Acid|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
12047423|NCT00223704|Drug|Placebo|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
12047424|NCT00223691|Drug|Atomoxetine|10-50 mg, PO. Single dose. Alone or in combination with Yohimbine or Mestinon.
12047426|NCT00223691|Drug|Pyridostigmine Bromide|30 mg-180 mg PO. Single dose. Alone or in combination with Yohimbine or atomoxetine.
12047427|NCT00223691|Drug|Yohimbine|2.7, 5.4 or 10.8 mg PO. Single dose. Alone or in combination with Atomoxetine or Pyridostigmine.
12047428|NCT00223691|Drug|Midodrine HCl|2.5, 5.0, 7.5, 10 mg PO. Single dose
12047429|NCT00223691|Drug|placebo|PO.Single dose.
12047430|NCT00223691|Drug|Modafinil|50-400 mg PO. Single dose
12047431|NCT00223691|Drug|Octreotide|5-50 µg, S.C. Single dose.
12047432|NCT00223691|Other|water intake|Tap water 2 onz., 8 oz., 16 oz. PO, alone or in combination with any of the above medications. Single dose.
12047433|NCT00223691|Drug|Diphenhydramine Hydrochloride|12.5 mg-100 mg PO. Single dose. Alone or in combination with Ranitidine
12047434|NCT00223691|Drug|Ranitidine HCL|150-300 mg PO. Single dose. Alone or in combination with Diphenhydramine.
12047435|NCT00223691|Drug|Tranylcypromine|5 - 40 mg PO. Single dose
12047436|NCT00223691|Drug|Ergotamine/ Caffeine|Ergotamine: 1.0 mg PO. Single dose. Caffeine 100 mg PO.Single dose
12047437|NCT00223691|Drug|Celecoxib|50-200 mg PO. Single dose
12047438|NCT00223691|Drug|Pseudoephedrine|15, 30 or 60 mg, PO. Single dose.
12047439|NCT00223691|Drug|Methylphenidate|5 or 10 mg PO. Single dose.
12047440|NCT00223691|Drug|Indomethacin|25, 50 or 75 mg, PO. Singe dose.
12047441|NCT00223691|Drug|Ibuprofen|300, 600 or 900 mg, PO. Single dose.
12047442|NCT00223691|Drug|Oxymetazoline 0.05% nasal solution|1-2 sprays/ nostril. Single dose.
12047443|NCT00223691|Dietary Supplement|Bovril|6-10 g, PO. Single dose.
12047444|NCT00223691|Drug|Acetazolamide|125-1000 mg PO. Single dose. Alone or in combination with yohimbine or midodrine
12047445|NCT00223691|Drug|Rivastigmine tartrate|1.5-6 mg PO. Single dose.
12047446|NCT00223691|Drug|Carbidopa/levodopa|10mg/100mg or 25mg/100mg. 1-2 tab PO. Single dose. Alone or in combination with carbidopa (Lodosyn) 25-175 mg
12047447|NCT00223691|Device|Inflatable abdominal binder|External abdominal compression (20-40 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).
12047448|NCT00223691|Device|inflatable abdominal binder (sham)|External abdominal compression (5 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).
12047449|NCT00223678|Drug|Rapamycin|Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
12047450|NCT00223665|Drug|Flutamide|Flutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate.
12047451|NCT00223665|Drug|Leuprolide Acetate|Leuprolide Acetate dosed at 7.5mg intramuscular (IM) injections once per month for a total of 9 months.
12047452|NCT00223652|Behavioral|Telephone cognitive behavioral therapy|An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.
12047453|NCT00223639|Drug|Topiramate|200mg twice a day
12047454|NCT00223626|Drug|Topiramate|the maximum topiramate test dose is 200 mg/d.
12047455|NCT00223613|Drug|daily intranasal administration of insulin|
12047456|NCT00223600|Behavioral|Nutritional and life style counseling|
12047457|NCT00223587|Other|1 week of treatment discontinuation|1 week of treatment discontinuation during allergic rhinitis season
12047458|NCT00223574|Drug|Control - high carbohydrate, high glycemic index foods|
12047459|NCT00223574|Drug|high carbohydrate, low glycemic index foods|
12047460|NCT00223574|Drug|low carbohydrate, high monounsaturate fat foods|
12047461|NCT00223561|Drug|methylphenidate|
12047462|NCT00223548|Drug|sodium 2-mercaptoethane sulfonate|
12047463|NCT00223535|Behavioral|Cognitive Remediation|
12047464|NCT00223535|Behavioral|Social Skills Training|
12047465|NCT00223522|Device|MEMS caps|
12047466|NCT00223509|Drug|Lamotrigine|
12047467|NCT00223496|Drug|Aripiprazole|Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
12047468|NCT00223483|Genetic|Isolation of genomic DNA|One time blood draw
12047469|NCT00223457|Behavioral|Factors that influence compliance|
12047470|NCT00223431|Device|all-ceramic fixed partial denture|
12047471|NCT00223418|Drug|aripiprazole|
12047472|NCT00223405|Device|crown placement|
12047473|NCT00223379|Procedure|Endodontic procedure with varied apical preparation size|Comparison of two commonly used techniques for performing root canal treatment: 1) Lightspeed method 2)Buchannan method
12047474|NCT00223353|Other|Prosthetics, Orthotics and Physical Therapy|Gait Analysis.
12047475|NCT00223340|Behavioral|Patient Activation and Diabetes Registry|
12047476|NCT00223314|Behavioral|HIV, STD, Pregnancy Prevention Curriculum|The curriculum is designed to change students' knowledge, perceptions of norms, beliefs, self-efficacy, interpersonal skills (i.e., refusal skills), and high-risk behaviors related to HIV. The curriculum included use of facilitators for selected lessons such as role playing. Intervention strategies included demonstrations of skills by role playing, use of role model stories, and other experiential learning techniques. The curriculum was delivered during the school days by facilitators (project staff) who received intensive training prior to implementation and coaching and support during implementation.
12047477|NCT00223301|Drug|Mycophenolate Mofetil (cellcept)|
12047478|NCT00223288|Drug|Lexapro|
12047479|NCT00223275|Drug|Naltrexone|
12047480|NCT00223262|Drug|Lamotrigine (Drug)|
12047481|NCT00223249|Drug|Quetiapine|
12047482|NCT00223236|Drug|Citicoline|Citicoline or placebo will be given beginning at one table (500mg)/day with an increase to two tablets (1000mg)/day at week 2, three tablets (1500mg)/day at week 4 and four tablets (2000mg)/day at week 6. Patients will remain on 2000mg/day through week 12. Doses will be decreased if needed due to side effects.
12047483|NCT00223236|Drug|Placebo|Placebo matching active medication in all other aspects.
12047484|NCT00223223|Drug|Levetiracetam, Keppra|
12047485|NCT00223210|Drug|Quetiapine|Active Quetiapine
12047486|NCT00223210|Drug|PLacebo|Placebo
12047487|NCT00223197|Drug|Pregnenolone|
12047488|NCT00223171|Drug|Androgen blockade + radiation therapy|Androgen blockade + radiation therapy
12047489|NCT00223158|Drug|Liothyronine|
12047490|NCT00223145|Radiation|Radiotherapy 70 Gy|Radiotherapy to the prostate
12047491|NCT00223145|Radiation|Radiotherapy 76 Gy|Radiotherapy to the prostate
12047492|NCT00223145|Drug|Androgen blockade|Duration : 6 months
12047493|NCT00223132|Device|Absorbable sutures|
12047494|NCT00223119|Device|Absorbable Sutures|
12047495|NCT00223106|Device|Vaginal Sling|
12047496|NCT00223093|Drug|TAIZ|
12047497|NCT00223080|Biological|ALVAC-HIV vCP1521 + AIDSVAX|Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
12047498|NCT00223080|Other|ALVAC Placebo + AIDSVAX Placebo|ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
12047499|NCT00223067|Drug|TAIZ|
12047500|NCT00223054|Drug|tacrolimus|retrospective analyze of drug levels in comparison to polymorphism
12047501|NCT00223054|Drug|sirolimus|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
12047502|NCT00223054|Drug|everolimus|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
12047503|NCT00223054|Drug|cyclosporin A|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
12047504|NCT00223041|Drug|Fluvastatin|Arm A receives fluvastatin Arm b receives no fluvastatin
12047505|NCT00223028|Drug|sirolimus, mycophenolat mofetil, fluvastatin|
12047506|NCT00223015|Drug|Fluvastatin, Tacrolimus, Mycophenolat Mofetil|
12047507|NCT00223002|Drug|Chlorhexidine|sample collected at time of procedure and then analysed for bacterial contamination
12047508|NCT00222989|Drug|PPI|
12047509|NCT00222976|Drug|Naproxen|Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
12047510|NCT00222937|Behavioral|Lessac-Madsen Resonant Voice Therapy|Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
12047511|NCT00222937|Behavioral|Casper-Based Confidential Flow Therapy|Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
12047512|NCT00222924|Behavioral|weight loss/ exercise|
12047513|NCT00222911|Device|dorsiflexion night splint|
12047514|NCT00222911|Device|medial arch support|
12047515|NCT00222898|Procedure|DNA analysis of pancreatic cyst fluid / buccal swab|
12047516|NCT00222872|Drug|Parathyroid Hormone-related Protein|PTHrP(1-36) starting at 500 micrograms, then increasing by 125 micrograms up to a maximum of 1,500 micrograms.
12047517|NCT00222872|Drug|Placebo|Placebo drug via subcutaneous injection in single blinded fashion daily for 3 weeks
12047518|NCT00222846|Behavioral|Attention control|Participants attend 3 educational seminars, receive a lay diabetes journal, pedometer, and glucose monitoring supplies.
12047519|NCT00222846|Behavioral|Intervention|Behavioral intervention of diabetes self-management paired with PDA-based monitoring of dietary intake and physical activity. Participants also receive a pedometer and glucose self-monitoring supplies.
12047520|NCT00222833|Drug|Aripiprazole|
12047521|NCT00222820|Drug|escitalopram|
12047522|NCT00222820|Behavioral|Interpersonal Psychotherapy|
12047523|NCT00222794|Drug|Atomoxetine (Strattera)|
12047524|NCT00222755|Behavioral|Disease Management|Self-management, care management, guidelines
12047525|NCT00222742|Procedure|induced moderate hypothermia|Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.
12047526|NCT00222729|Drug|Pemetrexed|500 mg/m2 day 1 q 21 days
12047527|NCT00222729|Drug|Bevacizumab|15 mg/kg IV q 21 days following pemetrexed
12047528|NCT00222716|Behavioral|Problem solving counseling|Telephone nurse counseling behavioral intervention focused on problem solving.
12047529|NCT00222703|Behavioral|Smoking relapse prevention|
12047530|NCT00222677|Drug|aspirin|100 mg daily
12047531|NCT00222664|Biological|Hep-V Vax|
12047532|NCT00222651|Drug|tenecteplase|
12047533|NCT00222638|Drug|Influenza vaccination|
12047534|NCT00222625|Drug|rFVIIa + (vit K in AO patients)|
12047535|NCT00222625|Drug|FFP or aPCC+ vit K in AO treated patients|
12047536|NCT00222612|Other|Reduced intensification|Deletion of one 7 week treatment block containing dexamethasone, vincristine, doxorubicin, Peg-asparaginase, intrathecal methotrexate, cyclophosphamide, cytarabine.
12047537|NCT00222612|Drug|Standard childhood UK ALL protocol|No additional treatment to standard protocol.
12047538|NCT00222612|Drug|Intensified treatment including Capizzi maintenance|Augmented consolidation: vincristine, Peg-asparaginase. Capizzi maintenance: iv methotrexate and peg-asparaginase
12047539|NCT00222573|Drug|clopidogrel and metoprolol|
12047540|NCT00222560|Behavioral|Intensive physical activity counselling by an integrated physical activity counsellor|
12047541|NCT00222547|Drug|Vitamin A|
12047542|NCT00222547|Drug|Albendazole|
12047543|NCT00222534|Drug|Acetazolamide|
12047544|NCT00222534|Drug|Placebo|
12047545|NCT00222521|Drug|Glargine insulin|
12047546|NCT00222495|Drug|quetiapine|
12047547|NCT00222495|Drug|olanzapine|
12047548|NCT00222495|Drug|risperidone|
12047549|NCT00222482|Drug|Depakote ER|
12047550|NCT00222469|Drug|bevacizumab|10mg/kg IV on Day 1 Q 2 weeks
12047551|NCT00222469|Drug|gemcitabine|1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
12047552|NCT00222469|Drug|oxaliplatin|100mg/m2 on Day 2 and Q 2 weeks.
12047553|NCT00222456|Behavioral|Sensitizing parents|
12047554|NCT00222443|Drug|Irinotecan|
12047555|NCT00222430|Procedure|Fluoroscopy|Use of fluoroscopy during arterial insertion of coronary catheter
12047556|NCT00222430|Procedure|Active Comparator|Standard coronary angiography technique; no fluoroscopic assistance
12047557|NCT00222417|Procedure|myringoplasty|Myringoplasty is an operative procedure to close tympanic membrane perforations.
12047558|NCT00222417|Procedure|Stapes surgery|Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis
12047559|NCT00222365|Drug|Arnica montana, 5 CH|
12047560|NCT00222365|Drug|Bryonia alba, 5 CH|
12047561|NCT00222365|Drug|Hypericum perforatum, 5 CH|
12047562|NCT00222365|Drug|Ruta graveolens, 3 DH|
12047563|NCT00222352|Diagnostic Test|Point of Care cTnL testing|"The study design will be a phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. The experimental group of interest will be patients receiving the POC cTnI test, and the control group will be patients receiving the central laboratory cTnI test.
~The treating physician will be blinded to the randomization and will receive only the POC results from half the study patients and only the laboratory results for the remaining half."
12047564|NCT00222339|Behavioral|task-specific training|
12047565|NCT00222326|Behavioral|Pelvic floor muscle training and lifestyle modification|
12047566|NCT00222300|Behavioral|Strength training program|
12047567|NCT00222287|Behavioral|Feldenkrais Movement class|
12047568|NCT00222274|Behavioral|RSA Biofeedback|RSA Biofeedback Condition. The biofeedback will consist of 10 weekly sessions of training, at the same time of day for each subject. The details of the procedure for RSA biofeedback are described in Appendix A. One single practitioner, a certified biofeedback technician, will provide the biofeedback following the aforementioned protocol. In each session, 20 minutes of biofeedback will be delivered using a J&J C-2+ Physiograph. The participant will be taught to breathe at her resonant frequency, as a first step to training the individual how to produce maximal increases in amplitude of RSA.
12047569|NCT00222274|Behavioral|EEG Biofeedback Condition|EEG Biofeedback Condition. Participants assigned to this condition will receive 10 sessions of EEG alpha biofeedback. In each session, 20 minutes of biofeedback will be delivered using a J&J I-330-C2+ physiograph. The participant will learn how to modify specific brainwave activity known as alpha. In particular, participants will be taught to increase amplitude of alpha in the range of 8-12 Hz. Increased amplitude is this range is associated with relaxation and reduction of anxiety, but not baroreflex gain. Participants will also practice for two 20-minute periods daily using the same methods used to increase alpha found in lab sessions.
12047570|NCT00222261|Drug|aspirin|Aspirin 160 mg once daily for two years
12047571|NCT00222261|Drug|clopidogrel|clopidogrel 75 mg once daily for two years
12047572|NCT00222248|Behavioral|Pelvic floor muscle training and bladder training|
12047573|NCT00222235|Drug|d-cycloserine|
12047574|NCT00222235|Drug|glycine|
12047575|NCT00222235|Drug|placebo|
12047576|NCT00222222|Procedure|vein puncture|comparison of different inflammatory markers in the blood of septic patients
12047577|NCT00222209|Behavioral|Experimental heat pain model|
12047578|NCT00222196|Procedure|lifestyle, PTA|
12047579|NCT00222183|Drug|Elidel (pimecrolimus)|
12047580|NCT00222170|Drug|Rabeprazole|
12047581|NCT00222144|Drug|Gleevec and Taxotere|Gleevec 600 mg QD for 12 months Taxotere IV 30 mg/m2 on day 1, 8 and 15
12047582|NCT00222131|Drug|Esomeprazole|Esomeprazole 40 mg QD
12047583|NCT00222131|Other|Placebo|Placebo
12047584|NCT00222118|Behavioral|labor/birth preparation classes|prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks
12047585|NCT00222118|Other|intervention|prenatal classes and phone calls from peer counselor, peer counselor/lactatin consultant, hospital visit, telephone support to 4 weeks postpartum
12047586|NCT00222118|Other|usual care|no intervention
12047587|NCT00222105|Drug|Doxil|Doxil 40 mg/m2 IV day 1
12047588|NCT00222105|Drug|Thalidomide|50-100 mg day 1-28
12047589|NCT00222105|Drug|Dexamethasone|Dexamethasone 40 mg day 1-4 and 15-18
12047590|NCT00222079|Drug|Esomeprazole (Nexium)|
12047591|NCT00222066|Procedure|Fetal ovarian cyst aspiration|Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia
12047592|NCT00222053|Drug|Thalidomide|Per os thalidomide
12047593|NCT00222053|Drug|Biphosphonates|Biphosphonates
12047594|NCT00222040|Radiation|Ultrasound|2-MHz, low intensity transcranial ultrasound
12047595|NCT00222040|Drug|Levovist|D-Galactose and palmitic palmitique intravenous 4 g
12047596|NCT00222027|Procedure|Collection of treatment-stratefying prognostic factors|
12047597|NCT00222014|Procedure|TIPS|Transjugular intrahepatic portosystemic shunt with covered PTFE
12047598|NCT00222014|Procedure|Paracenthese|Paracenthese
12047599|NCT00221988|Drug|Levetiracetam (Keppra)|
12047600|NCT00221975|Drug|Divalproex|Once a therapeutic blood level of lithium was achieved, Divalproex was initiated at 250 mg twice daily and increased slowly over 5 weeks to a minimum blood level of 50 μg/mL.
12047601|NCT00221975|Drug|Lamotrigine|Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over 3 weeks to a minimum blood level of 0.5 mEqlL.
12047602|NCT00221975|Drug|Lithium|Subjects who did not respond to the combination of Lithium and Divalproex were then randomly assigned in a 1:1 ratio to adjunctive lamotrigine versus placebo after stratification by illness type (bipolar I versus bipolar II), historical response to lithium (response versus oon-response), and the length of current exposure to the combination treatment with lithium and divalproex (<2 months versus ≥2 months).
12047603|NCT00221962|Drug|Aripiprazole|Open label
12047604|NCT00221949|Device|Ultrasound|
12047605|NCT00221936|Behavioral|Self-administration or nurse administered medication|
12047606|NCT00221910|Procedure|Ultrasound|
12047607|NCT00221884|Procedure|Ultrasound|
12047608|NCT00221871|Drug|Different dosages of Ketamine|
12047609|NCT00221858|Procedure|Ultrasound guided blocks|
12047610|NCT00221845|Drug|ACE Inhibition|ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.
12047611|NCT00221845|Drug|Intensified Blood Pressure Control|Any antihypertensive drugs except ACE inhibitors and angiotensin receptor blockers will be allowed.
12047612|NCT00221845|Drug|Add-on Angiotensin Receptor Blockade|In patients who show persistent or breakthrough proteinuria at the end of the initial study period, telmisartan (50 mg/m²/day) will be added to the existing medication.
12047613|NCT00221819|Device|heated humidifier (device)|
12047614|NCT00221819|Device|Heat and moisture exchanger (device)|
12047615|NCT00221806|Device|endothelialised prosthesis|
12047730|NCT00220675|Drug|Erythropoietin infusion|
12047616|NCT00221793|Procedure|Deep brain stimulation|Brain Stimulation of the Subthalamic Nucleus
12047617|NCT00221780|Device|left ventricular pacing|
12047618|NCT00221767|Device|Brindley technique (bladder system)|Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
12047619|NCT00221754|Drug|Pravastatin (drug)|
12047620|NCT00221741|Drug|Fresh Frozen Plasma (blood product)|
12047621|NCT00221728|Device|Radiofrequency|
12047622|NCT00221728|Procedure|conservative surgery|
12047623|NCT00221715|Device|femoropopliteal artery bypass|Bypass by autologous saphenous vein
12047624|NCT00221715|Device|femoropopliteal artery bypass|bypass by dacron or PTFE Prosthesis
12047625|NCT00221702|Drug|PegIntron|100 mcg SC/week for 36 months
12047626|NCT00221702|Drug|intron A|3mui TIWW SC for 18 months
12047627|NCT00221689|Drug|baclofen (drug)|
12047628|NCT00221676|Biological|Alfarix|
12047629|NCT00221663|Device|surgery techniques (sternotomy for aortic valve replacement)|
12047630|NCT00221650|Drug|Peginterferon alfa2a|
12047631|NCT00221650|Drug|Ribavirin|
12047632|NCT00221637|Drug|Sodium Valproate|
12047633|NCT00221624|Drug|Peginterferon alfa-2a|
12047634|NCT00221624|Drug|ribavirin|
12047635|NCT00221624|Drug|amantadine|
12047636|NCT00221611|Drug|Administration of intrathecal baclofen|
12047637|NCT00221598|Procedure|Haemodialysis with different dialysate temperatures|Haemodialysis with different dialysate temperatures is used.
12047638|NCT00221585|Behavioral|Psychosocial treatment/Psychodynamic treatment|
12047639|NCT00221572|Procedure|Determination of bot density of Cystic Fibrosis patients|Determination of bot density of Cystic Fibrosis patients.
12047640|NCT00221559|Procedure|Blood sampling for determination of serum Zn|
12047641|NCT00221546|Drug|Giving DHA-rich supplement|Giving DHA-rich supplement to patients.
12047642|NCT00221520|Drug|midazolam with 2 different levels of sedation scores|
12047643|NCT00221507|Behavioral|Reminder-Recall-Outreach|
12047644|NCT00221507|Behavioral|Case Management|
12047645|NCT00221507|Behavioral|Patient Navigator|
12047646|NCT00221494|Drug|citalopram + tiodothyronine, or + pindolol, or + placebo|
12047647|NCT00221481|Drug|divalproex or olanzapine|
12047648|NCT00221468|Drug|quetiapine|100mg of quetiapine on day 1 and titrated to a maximum dose of 400mg by day 4, with flexible dosing to 600mg by day 28. The total duration of treatment will be 84 days (12 weeks).
12047649|NCT00221455|Behavioral|Patient diabetic self-management using the diabetic patient portal tools|
12047650|NCT00221455|Behavioral|A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.|
12047651|NCT00221442|Drug|Zonegran|zonegran (zonisamide)
12047652|NCT00221442|Drug|sugar pill|fake pill
12047653|NCT00221429|Drug|lithium sodium divalproex|
12047654|NCT00221416|Drug|Aripiprazole|5-20 mg/day
12047655|NCT00221403|Drug|Risperidone oral solution|liquid, BID dosing.
12047656|NCT00221403|Drug|Valproate Oral Solution|liquid, BID dosing.
12047657|NCT00221403|Other|Placebo|liquid, BID dosing.
12047658|NCT00221390|Drug|Ropinirole (+ physical therapy)|
12047659|NCT00221390|Drug|(vs.) Placebo + physical therapy|
12047660|NCT00221377|Device|Intubation using tracheal tubes with or without cuff|
12047661|NCT00221364|Drug|Mass treatment with oral azithromycin to an entire village|
12047662|NCT00221351|Procedure|CRP point of care testing|
12047663|NCT00221338|Drug|Gabapentin|This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
12047664|NCT00221325|Drug|Intraventricular Rituximab Plus MTX|"Intraventricular injection of rituximab into an Ommaya reservoir on day 1 of each week. Intraventricular rituximab plus methotrexate (MTX) on day 4 of each week.
~First three patients at dose A : 25 mg rituximab on day 1, and MTX (12 mg) plus rituximab (10 mg) on day 4 each week.
~If there are no dose limiting toxicities at Dose A in all of the first 3 patients or in 5 of the first 6 patients, the next 3 patients will receive dose level B: 25 mg rituximab on day 1, and combination MTX (12 mg) plus rituximab (25 mg) on day 4 of each week.
~Oral leucovorin rescue 24 hours after each MTX administration. Maximum injections will be 16 over 9-weeks. Subjects who experience a partial response at week 10 will be given the option for extended dosing."
12047665|NCT00221312|Drug|Fosamax|
12047666|NCT00221299|Drug|Risedronate|One 35mg tab of risedronate/placebo taken once a week for one year.
12047667|NCT00221299|Drug|Parathyroid Hormone|This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
12047668|NCT00221286|Drug|pegylated interferon alfa-2a|
12047669|NCT00221286|Drug|tenofovir DF / emtricitabine combination therapy|
12047670|NCT00221286|Drug|pegIFN / TDF / FTC combination therapy|
12047671|NCT00221273|Procedure|ACL surgery|
12047672|NCT00221260|Procedure|anesthesia|Intraoperative general anesthesia AND postoperative IV narcotic analgesia.
12047673|NCT00221247|Procedure|Acupuncture|acupuncture
12047674|NCT00221234|Behavioral|Print materials, pedometers/logbooks|
12047675|NCT00221234|Behavioral|Print materials, pedometers/logbooks, telephone counselling|
12047676|NCT00221221|Device|Pedometer|
12047677|NCT00221221|Device|Exercise guidebook|
12047678|NCT00221208|Behavioral|Resistance Training|
12047679|NCT00221195|Drug|activated prothrombin complex concentrate (FEIBA)|"FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months
~FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months"
12047680|NCT00221182|Genetic|Autologous peripheral blood CD34 positive cell therapy|
12047681|NCT00221169|Procedure|Surgical resection|pet ct prior to surgery
12047682|NCT00221156|Drug|Acarbose|
12047683|NCT00221143|Genetic|Autologous peripheral blood CD34 positive cell therapy|
12047684|NCT00221130|Procedure|surgical operation of cell transplantation|
12047731|NCT00220662|Behavioral|Readiness and Motivation Therapy|
12047685|NCT00221117|Device|Neuroprosthesis-FES Therapy|The Compex Motion neuroprostesis, developed by Drs. R. Popovic and Thierry Keller,and company Compex SA, ia a flexible device designed to improve grasping function in both SCI and stroke patients.This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp , and holds a number of advantages over the other existing neuroprostheses.
12047686|NCT00221117|Other|Conventional Ocupational Therapy (COT)|Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.
12047687|NCT00221104|Drug|Pravastatin|
12047688|NCT00221091|Procedure|ventriculo-peritoneal shunt|
12047689|NCT00221078|Device|Neuroprosthesis|The Compex Motion neuroprosthesis, developed by Drs.R. Popovic and Thierry Keller, and company Compex SA, is a flexible device designed to improve grasping function in both SCI and stroke patients. This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp, and holds a number of advantages over the other existing neuroprostesis.
12047690|NCT00221065|Device|Nasal Continuous positive airway pressure - Tyco 420G|CPAP at determined pressure nightly for 1 month
12047691|NCT00221052|Drug|Diclofenac|
12047692|NCT00221039|Drug|Methoxsalen+ECP|UVAdex+ECP will be administered: Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months
12047693|NCT00221026|Drug|Methoxsalen +ECP|ECP + Uvadex given at weeks 1-12 weeks.
12047694|NCT00221026|Procedure|Extracorporeal Photopheresis|ECP given at weeks 1 through 12.
12047695|NCT00221013|Procedure|"augmented CRRT regimen"|We randomly assigned critically ill patients with acute kidney injury to receive CRRT in the form of post-dilution continuous veno-venous hemodiafiltration (CVVHDF) at 25 ml/kg/hr (lower intensity) or 40 ml/kg/hr (higher intensity) of effluent flow.
12047696|NCT00221000|Drug|Methoxsalen|
12047697|NCT00221000|Procedure|Extracorporeal Photopheresis|
12047698|NCT00220987|Other|Intensive Insulin Therapy|Maintain blood glucose 4.5 - 6.o mmol/L
12047699|NCT00220987|Other|Conventional Insulin therapy|Maintain blood glucose 8-10mmol/L
12047700|NCT00220974|Behavioral|Internet-based tailored advice on cardiovascular risk|
12047701|NCT00220961|Drug|Pioglitazone|Pioglitazone tablets - 45 mg/day
12047702|NCT00220961|Drug|Placebo|Placebo tablets similar to pioglitazone tablets - 1 tablet/day
12047703|NCT00220948|Procedure|CERSR Myoelectric monitoring during standardized tasks|
12047704|NCT00220935|Device|Orthotrac Pneumatic Vest|
12047705|NCT00220922|Procedure|Alcohol Wipes vs. No Alcohol Wipes|
12047706|NCT00220909|Drug|Lansoprazole|
12047707|NCT00220896|Drug|Donepezil|
12047708|NCT00220870|Behavioral|Decision aid|
12047709|NCT00220857|Drug|Rabeprazole|
12047710|NCT00220844|Drug|Desipramine|
12047711|NCT00220844|Drug|Amitriptyline|
12047712|NCT00220831|Drug|Natural source Vitamin E 400IU/day|
12047713|NCT00220818|Drug|Lansoprazole|Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
12047714|NCT00220818|Drug|Lansoprazole|Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
12047715|NCT00220805|Drug|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified|The dose per infusion cycle was 2 g/kg body weight over 5 consecutive days (= 4 mL/kg body weight/infusion). The infusion duration was approximately 1.5 - 2 h.
12047716|NCT00220805|Drug|Albumin (Human) 25%, United States Pharmacopeia (USP)|Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.
12047717|NCT00220792|Behavioral|Brief supportive-expressive group therapy|
12047718|NCT00220779|Drug|Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified|
12047719|NCT00220779|Drug|Albumin (Human) 25%, United States Pharmacopeia (USP)|
12047720|NCT00220766|Drug|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified|
12047721|NCT00220766|Drug|Dextrose, 5% in Water|
12047722|NCT00220753|Device|IQAir Allergen 100 Air cleaners|Two air cleaners are installed in the patient's room, one in his bedroom, and one in the living room. The cleaners can be run at 5 different speeds: Speed 1 filtrates 60m3 of air per hour, speed 2 filtrates 90 m3 per hour, speed 3 filtrates 130 m3 per hour, speed 4 filtrates 240 m3 per hour, and speed 5 filtrates 380 m3 per hour. A timer-on period can be pre-set for every day of the week, but the cleaner can be run even in the timer-off period, at a speed pre-set and different from the timer-on period. Different timer-on off periods cannot be selected for different days, but the different days of the week can be pre-set to apply timer-on periods or not.
12047723|NCT00220740|Drug|Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified|2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
12047724|NCT00220740|Drug|Albumin (Human) 25%, United States Pharmacopeia (USP)|Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
12047725|NCT00220727|Drug|Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified|IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.
12047726|NCT00220714|Drug|atypical antipsychotics:oral vs. long-acting route|
12047727|NCT00220714|Behavioral|Family Psychoeducation|
12047728|NCT00220701|Drug|Lexapro (escitalopram)|antidepressant drug selective serotonin reuptake inhibitor (SSRI)
12047729|NCT00220688|Device|Acupressure Wristbands|
12047732|NCT00220649|Drug|gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin|
12047733|NCT00220636|Drug|Aripiprazole|Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.
12047734|NCT00220623|Drug|antidepressant medications, flexible drug choice|
12047735|NCT00220623|Behavioral|CBT, Psychodynamic or Supportive Psychotherapy|
12047736|NCT00220610|Device|Transcranial magnetic stimulation|
12047737|NCT00220597|Behavioral|Trauma-focused group therapy|
12047738|NCT00220584|Drug|donepezil|donepezil 5 mg daily for 3 weeks (days 1-21); 10 mg daily for 3 weeks (days 22-42)
12047739|NCT00220571|Device|Coronary Angioplasty (PTCA)|
12047740|NCT00220558|Device|Coronary placement of bare metal stent vs. drug eluting stent|
12047741|NCT00220545|Procedure|Laparoscopic ovarian diathermy|
12047742|NCT00220532|Drug|Folic acid with riboflavin|
12047743|NCT00220519|Drug|Lactobacillus GG|
12047744|NCT00220506|Drug|Provigil|
12047745|NCT00220493|Drug|Ritalin|
12047746|NCT00220480|Drug|escitalopram|10 to 30 mg / day
12047747|NCT00220467|Behavioral|Aerobic exercise|
12047748|NCT00220454|Drug|Climara|
12047749|NCT00220454|Drug|Hydrocortone|
12047750|NCT00220441|Behavioral|Aerobic exercise|
12047751|NCT00220428|Biological|T-Cell Vaccination|
12047752|NCT00220415|Drug|SPM 927|
12047753|NCT00220402|Drug|SPM 907|
12047754|NCT00220389|Drug|SPM 907|
12047755|NCT00220376|Drug|SPM 907|
12047756|NCT00220363|Drug|SPM 907|
12047757|NCT00220350|Drug|leuprolide acetate|
12047758|NCT00220337|Drug|lacosamide|Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
12047759|NCT00220324|Drug|Minisiston (SH D00342A)|Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval
12047760|NCT00220311|Drug|Fludarabine Phosphate (Fludara)|6 cycles (1 cycle: 5 treatment days every 28 days)
12047761|NCT00220298|Drug|Testosterone undecanoate (TU) - NebidoTM|Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals
12047762|NCT00220285|Drug|Zevalin (SH L 749 , BAY86-5128)|0,3mCi/kg
12047763|NCT00220285|Drug|Zevalin (SH L 749 , BAY86-5128)|0,4mCi/kg
12047764|NCT00220272|Drug|SR57667B|
12047765|NCT00220259|Drug|Fluticasone or placebo|
12047766|NCT00220233|Drug|olmesartan medoxomil|
12047767|NCT00220233|Drug|amlodipine|
12047768|NCT00220233|Drug|hydrochlorothiazide|
12047769|NCT00220220|Drug|olmesartan medoxomil|
12047770|NCT00220220|Drug|amlodipine|
12047771|NCT00220207|Behavioral|Internet co-management module|
12047772|NCT00220194|Drug|leuprolide acetate|
12047773|NCT00220168|Drug|Irinotecan, Capecitabine|
12047774|NCT00220155|Drug|Gemcitabine|
12047775|NCT00220129|Drug|Epirubicin, Cisplatin, Capecitabine|
12047776|NCT00220129|Procedure|Surgical Resection|
12047777|NCT00220116|Drug|Capecitabine, Oxaliplatin|
12047778|NCT00220103|Drug|epirubicin, capecitabine, cisplatin|
12047779|NCT00220103|Procedure|Surgical resection|
12047780|NCT00220090|Drug|dexloxiglumide|
12047781|NCT00220077|Procedure|Endoscopy|
12047782|NCT00220064|Drug|Irinotecan, 5-Fluorouracil, Leucovorin|
12047783|NCT00220051|Drug|Oxaliplatin, Capecitabine|
12047784|NCT00220051|Procedure|Pre operative radiotherapy|
12047785|NCT00220051|Procedure|Surgical Resection|
12047786|NCT00220038|Behavioral|smell tests|subjects are instructed to sniff two vials, one containing the solvent, the other a dilution of the odorant. They are asked to scan the vial with the stronger odor.
12047787|NCT00220025|Device|Phototherapy|The patient begins total body NBUVB that day at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until clearance of disease or maximum efficacy.
12047788|NCT00220012|Procedure|Folate depletion and supplementation|
12047789|NCT00219986|Drug|Potent HAART during acute or early HIV-1 infection|
12047790|NCT00219973|Drug|Bemiparin|Bemiparin 3.500 IU/day for 28 days compared to 8 days
12047791|NCT00219960|Drug|North American Ginseng (Panax Quinquefolius)|
12047792|NCT00219947|Other|blood draw|"T cell subset enumeration
~Serologic reactivity with HIV antigens
~Viral load assays by bDNA, PCR, or RT-PCR
~Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
~HIV-1 Resistance Testing"
12047793|NCT00219934|Drug|Antiretroviral therapy|HAART therapy
12047794|NCT00219921|Drug|Intrathecal morphine at surgery, 0.1mg and placebo|
12047795|NCT00219921|Drug|Patient Controlled Analgesia with iv morphine and placebo|
12047796|NCT00219921|Drug|intrathecal morphine AND patient controlled analgesia with iv morphine|
12047797|NCT00219908|Drug|Mitoxantrone|
12047798|NCT00219895|Drug|Ibuprofen|
12047799|NCT00219882|Drug|standardized turmeric root extract|1.5 gm of standardized tumeric root extract three times per day for seven consecutive days, followed by 3 gm of standardized tumeric root extract three times per day for seven consecutive days
12047800|NCT00219869|Drug|Galantamine|
12047801|NCT00219856|Drug|Propofol|"Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml
~Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml"
12047802|NCT00219856|Drug|Penthotal|Intravenous penthotal at the dose of 3 to 5 mg/kg
12047803|NCT00219856|Drug|Desflurane|Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
12047804|NCT00219843|Drug|PV-10 (rose bengal disodium, 10%)|
12047805|NCT00219830|Behavioral|home-based walking program|Home-based walking program; included use of pedometer and daily walk diary
12047806|NCT00219817|Drug|RC-1291 HCl|
12047807|NCT00219804|Drug|tetrabenazine or placebo|
12047808|NCT00219791|Drug|glucarpidase (50 Units/kg)|
12047809|NCT00219778|Drug|mifepristone|
12047810|NCT00219765|Drug|Imatinib mesylate 600 mg|
12047811|NCT00219765|Drug|Cytarabine|
12047812|NCT00219765|Drug|Daunorubicine|
12047813|NCT00219752|Drug|Imatinib mesylate 400 mg|
12047814|NCT00219739|Drug|Imatinib mesylate 400 mg|
12047815|NCT00219739|Drug|Imatinib mesylate 600 mg|
12047816|NCT00219739|Drug|Imatinib 400 mg + Peg-Interferon|
12047817|NCT00219739|Drug|Imatinib mesylate 400 mg + Cytarabine|
12047818|NCT00219726|Drug|Imatinib mesylate|
12047819|NCT00219713|Drug|nitrous oxide and oxygen|
12047820|NCT00219700|Drug|Ibuprofen-PC|
12047821|NCT00219687|Other|dispatcher-assisted CPR with compressions & ventilations|Delivery of telephone CPR instructions to lay callers with chest compressions and ventilations when the patient is identified to be in cardiac arrest
12047822|NCT00219687|Other|dispatcher-assisted CPR instructions with compressions only|Delivery of telephone CPR instructions to lay callers with hands-only chest compressions when the patient is identified to be in cardiac arrest
12047823|NCT00219674|Behavioral|Group I: Video training|"Participants will receive the AED with a video that provides instructional training."
12047824|NCT00219674|Behavioral|Group II: Video training + enhanced self-efficacy (SE)|Partcipants will receive the AED with instructional video, a manikin, and additional training materials by mail.
12047825|NCT00219674|Behavioral|Group III: In-person training + enhanced SE|Participants will receive a face-to-face training session in their home as well as the AED with instructional video, manikin and training materials.
12047826|NCT00219674|Behavioral|Group IV: In-person training + enhanced SE + support|Participants will receive a face-to-face training session in their home as well as the AED, instructional video, manikin, and a resource manual with information to enhance the family member's confidence in their role as care provider.
12047827|NCT00219661|Procedure|drainage of subglottic secretions (HiLo Evac tube)|
12047828|NCT00219648|Drug|PEP03|
12047829|NCT00219635|Drug|UK-390,957|
12047830|NCT00219622|Drug|tofimilast|
12047831|NCT00219609|Drug|UK-390,957|
12047832|NCT00219596|Drug|Xalacom|
12047833|NCT00219596|Drug|unfixed Latanoprost and Timolol|
12047834|NCT00219583|Drug|UK-390,957|
12047835|NCT00219570|Drug|clindamycin|
12047836|NCT00219570|Drug|nadifloxacin|
12047837|NCT00219557|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
12047838|NCT00219557|Drug|AG-013736|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.
12047839|NCT00219557|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
12047840|NCT00219544|Drug|Pregabalin (Lyrica)|pregabalin 150mg/day (75mg BID)
12047841|NCT00219544|Drug|Pregabalin (Lyrica)|pregabalin 300 mg/day (150mg BID)
12047842|NCT00219544|Drug|Pregabalin (Lyrica)|pregabalin 600/day (300mg BID)
12047843|NCT00219544|Drug|Placebo|Placebo
12047844|NCT00219531|Behavioral|perception of rectal balloon distention|functional Magnetic Resonance Imaging (fMRI) study with measurement of brain MRI response to rectal balloon distention.
12047845|NCT00219518|Procedure|defecography|insertion of catheter to record pressure. Insertion of barium to outline rectum and fluoroscopy to define change in rectal contour and expulsion of barium during the study.
12047846|NCT00219505|Procedure|acupuncture|
12047847|NCT00219479|Drug|Phenytoin (Dilantin) levels during change in enteral feeding|
12047848|NCT00219466|Other|Zinc Oxide Diaper Rash Ointment|Desitin Original at diaper change
12047849|NCT00219466|Other|Aloe Vera/Tocopherol/Zinc Oxide Cream|Desitin Creamy at diaper change
12047850|NCT00219453|Device|Jet Injector with Protector Cap (HSI-500)|
12047851|NCT00219440|Other|Actos plus standard diet|Actos plus standard diet
12047852|NCT00219440|Other|Actos plus structured diet|Actos plus structured diet
12047853|NCT00219440|Other|Metformin plus standard diet|Metformin plus standard diet
12047854|NCT00219414|Device|Adacolumn Apheresis System|
12047855|NCT00219401|Biological|Pneumococcal 7 valent conjugate vaccine (Prevenar®)|Accelerated PCV vaccinaton.
12047856|NCT00219388|Drug|Levosimendan|
12047857|NCT00219375|Drug|Sivelestat sodium hydrate|0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
12047858|NCT00219375|Drug|Sivelestat sodium hydrate|0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
12047859|NCT00219362|Biological|one injection of vCP1452 at W0, W4, W8 and W20|
12047860|NCT00219362|Biological|one injection of vCP1452 at W4, W8 and W20|
12047861|NCT00219362|Biological|one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20|
12047862|NCT00219349|Behavioral|Cognitive Behavioral Therapy|14 weekly sessions of individualized CBT
12047863|NCT00219349|Drug|escitalopram|10-20 mg per day for 12 weeks
12047864|NCT00219336|Behavioral|Self-guided Motivational Intervention|Using a randomized two-group design, a self-guided motivational intervention based on Project CHOICES will be compared to an informational only intervention, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS.
12047865|NCT00219336|Behavioral|Informational Only|Using a randomized two-group design, an informational intervention using a brochure from the CDC will be compared to a self-guided motivational intervention based on Project CHOICES, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS
12047866|NCT00219323|Drug|Omalizumab|
12047867|NCT00219310|Drug|Famciclovir|
12047868|NCT00219297|Drug|Patupilone|
12047869|NCT00219284|Drug|Carbidopa/levodopa/entacapone|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.
12047870|NCT00219271|Drug|Zoledronic acid|
12047871|NCT00219258|Drug|Zoledronic acid|
12047872|NCT00219245|Drug|Rivastigmine|
12047873|NCT00219232|Drug|Rivastigmine Transdermal Patch|
12047879|NCT00219141|Drug|Aliskiren 150/300 mg|Aliskiren 150 mg tablets
12047880|NCT00219141|Drug|Losartan 50/100 mg|Losartan 50 or 100 mg capsules
12047881|NCT00219141|Drug|Aliskiren placebo|Aliskiren 150 mg placebo tablet
12047882|NCT00219141|Drug|Losartan 50/100 mg placebo|Losartan 50/100 mg placebo capsules
12047883|NCT00219128|Drug|aliskiren|
12047884|NCT00219115|Drug|aliskiren|
12047885|NCT00219102|Drug|aliskiren|
12047886|NCT00219089|Drug|aliskiren|
12047887|NCT00219076|Drug|aliskiren|
12047888|NCT00219063|Drug|aliskiren|
12047889|NCT00219050|Drug|aliskiren|
12047890|NCT00219037|Drug|aliskiren|
12047891|NCT00219024|Drug|aliskiren|
12047892|NCT00219011|Drug|aliskiren|
12047893|NCT00218998|Behavioral|exercise training|
12047894|NCT00218985|Behavioral|Exercise training|Intensity controlled exercise training before the scheduled bypass surgery
12047895|NCT00218972|Behavioral|Aerobic interval training|
12047896|NCT00218972|Behavioral|moderate intensity training|
12047897|NCT00218972|Behavioral|Recommendation of regular exercise|
12047898|NCT00218959|Behavioral|Narrative Exposure Therapy|Exposure based treatment for PTSD developed especially for refugees. Built upon Prolonged exposure treatment (Edna Foa) and Testimonial Therapy (Cientifuegos & Monelli).
12047899|NCT00218959|Behavioral|treatment as usual|
12047900|NCT00218946|Drug|Sucrose|30 % sucrose
12047901|NCT00218946|Device|Pacifier|
12047902|NCT00218946|Other|sterile water|
12047903|NCT00218933|Behavioral|Moderate intensity exercise training|12-weeks, 2-3 times per week moderate exercise-intensity (70% of peak heart rate)
12047904|NCT00218933|Behavioral|High intensity exercise training|12-weeks, 2-3 times per week high-intensity interval-training (95% of peak heart rate)
12047905|NCT00218920|Behavioral|Strength training|a strength training regime of 4 series with 5 repetitions each, at approximately 90% of 1 repetition maximum (RM), in a leg press apparatus to develop maximal strength mainly from neural adaptation with minimal weight gain due to muscular hypertrophy.
12047906|NCT00218920|Behavioral|continuous moderate-intensity aerobic training|The moderate-intensity group walked continuously for 47 min at 60-70% of maximum heart rate (HRmax) to ensure that the training protocols were isocaloric.
12047907|NCT00218920|Behavioral|high-intensity interval aerobic training|High-intensity training consisted of a 10 min warm-up period at 50-60% of HRmax [maximal HR (heart rate)], followed by 4×4-min intervals at 85-95% of HRmax with 3 min active breaks in between the intervals, consisting of walking or jogging at 50-60% of HRmax. The exercise session was terminated by a 5 min cool-down period.
12047908|NCT00218907|Procedure|Educational video|
12047909|NCT00218894|Procedure|Cataract surgery|surgery one one or two eyes by use of two different types of lenses and correcting for refraction
12047910|NCT00218881|Procedure|HIV educational video|
12047911|NCT00218868|Procedure|Skin scrape|scrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis
12047912|NCT00218855|Drug|thalidomide|tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.
12047913|NCT00218855|Drug|placebo|100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.
12047914|NCT00218842|Behavioral|Individualized exercise|individualized exercise, physical activity and training in daily life situations given by trained physical therapists and occupational therapists
12047915|NCT00218816|Behavioral|Nebulizer Education Intervention|Asthma Education
12047916|NCT00218816|Behavioral|Standard Asthma Education Groups|Asthma Education
12047917|NCT00218803|Behavioral|Nurse asthma education intervention|Asthma Education
12047918|NCT00218803|Behavioral|Control Group|Asthma Education
12047919|NCT00218790|Procedure|Cool Dialysate|Decreased temperature of the dialysis bath
12047920|NCT00218777|Behavioral|Comprehensive Behavioral Intervention for Tics|
12047921|NCT00218751|Behavioral|Home Visiting|
12047922|NCT00218725|Behavioral|Cognitive Therapy|The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis.
12047923|NCT00218725|Other|Enriched Care|The Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the case managers. Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health and substance abuse treatment in the community.
12047924|NCT00218712|Behavioral|Cognitive behavioral intervention|Cognitive behavioral intervention will include personalized cognitive counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
12047925|NCT00218712|Behavioral|Standard counseling|Participants will receive standard counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
12047926|NCT00218699|Behavioral|Cognitive-Behavioral Intervention|
12047927|NCT00218686|Behavioral|psychoeducational|psychoeducational
12047928|NCT00218686|Behavioral|control|VTC
12047929|NCT00218673|Behavioral|Peer mentor intervention|groups sessions, 8
12047930|NCT00218660|Drug|Naltrexone|150mg/day Naltrexone
12047931|NCT00218660|Behavioral|BRENDA|Psychosocial Treatment
12047932|NCT00218660|Behavioral|CBT|Cognitive Behavioral Therapy
12047933|NCT00218660|Drug|Placebo|
12047934|NCT00218634|Behavioral|CBT-AD|Cognitive behavioral therapy for adherence and depression consisting of 1 session focusing on adherence and 8 sessions consisting of cognitive behavioral therapy for medication adherence and depression.
12047935|NCT00218634|Behavioral|ETAU|Enhanced treatment as usual consisting of 1 session focused on adherence (the same session as the CBT-AD intervention) and 8 sessions for participants to complete self-reports and collect adherence data.
12047936|NCT00218621|Procedure|Buprenorphine / methadone|Parallel study to double blind, double dummy study evaluating safety and efficacy of buprenorphine vs methadone treatment for pregnant opioid dependent women
12047937|NCT00218608|Drug|Disulfiram|Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
12047938|NCT00218595|Behavioral|DBT|Dialectical behavior therapy plus opiate replacement medication.
12047939|NCT00218595|Behavioral|I/GDC|Individual and group drug counseling plus opiate replacement medication.
12047940|NCT00218582|Behavioral|Double Trouble in Recovery|Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment
12047941|NCT00218582|Behavioral|Standard psychiatric day treatment|Individual counseling, groups, medication
12047942|NCT00218569|Drug|Naltrexone|Naltrexone
12047943|NCT00218569|Drug|Placebo|Placebo
12047944|NCT00218556|Behavioral|Cognitive behavioral treatment for depression|Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C
12047945|NCT00218543|Drug|Atomoxetine|At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.
12047946|NCT00218530|Drug|Lofexidine|
12047947|NCT00218517|Drug|Selegiline hydrochloride|Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks
12047948|NCT00218517|Drug|Placebo|Matching placebo capsules using blue 00 capsules
12047949|NCT00218504|Drug|Tetrahydrocannabinol|Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo.
12047950|NCT00218491|Drug|N-Acetylcysteine|1200mg N-Acetylcysteine
12047951|NCT00218491|Drug|N-Acetylcysteine|2400mg N-Acetylcysteine
12047952|NCT00218491|Drug|Matching Placebo|Matching Placebo
12047953|NCT00218478|Behavioral|Cue Desensitization|During the study session, both groups will be shown a nature video and will be asked to handle and smell various items; these will act as the neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues.
12047954|NCT00218465|Drug|GW468816|Pharmacotherapies for Relapse Prevention
12047955|NCT00218465|Drug|Placebo Comparator: Placebo|
12047956|NCT00218452|Behavioral|Lifestyle counseling|assigned to a 6-week individual behavioral treatment involving: 1) a novel brief office intervention for cigarette smoking that includes a treatment component intended to eliminate binge drinking
12047957|NCT00218439|Drug|Paroxetine|10 mg for 1 week followed by 20 mg for 3 weeks
12047958|NCT00218439|Drug|Placebo|
12047959|NCT00218426|Drug|naltrexone implant|naltrexone implant is 1000 mg naltrexone
12047960|NCT00218426|Drug|oral naltrexone|oral naltrexone 50 mg/day
12047961|NCT00218426|Drug|oral placebo naltrexone|oral placebo naltrexone resembles active medication
12047962|NCT00218426|Drug|placebo implant|placebo implant resembles active medication
12047963|NCT00218413|Biological|NicVAX|100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
12047964|NCT00218413|Biological|NicVAX|200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
12047965|NCT00218413|Biological|NicVAX|200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
12047966|NCT00218413|Biological|NicVAX|300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
12047967|NCT00218413|Biological|NicVAX|400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
12047968|NCT00218387|Drug|Modafinil|200mg Modafinil
12047969|NCT00218387|Drug|Modafinil|400mg Modafinil
12047970|NCT00218387|Drug|Matching Placebo|Matching Placebo
12047971|NCT00218374|Drug|Gabapentin|Gabapentin initiated up to a daily dose of 2400mg PO x 5 weeks
12047972|NCT00218361|Drug|Hydromorphone|
12047973|NCT00218348|Drug|Dextro-Amphetamine Sulfate|
12047974|NCT00218335|Behavioral|Intervention Condition|In the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
12047975|NCT00218335|Behavioral|Control Condition|The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
12047976|NCT00218322|Drug|Atomoxetine hydrochloride|Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
12047977|NCT00218322|Drug|Placebo|Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
12047978|NCT00218309|Drug|Hydromorphone|
12047979|NCT00218296|Drug|Usual Care Group|Nicotine replacement therapy
12047980|NCT00218296|Other|Reduction Group|Subject selects preferred method for reduction.
12047981|NCT00218283|Drug|Nicotine Lozenge|Oral Nicotine replacement product
12047982|NCT00218283|Behavioral|Behavioral Counseling|Use of behavioral counseling to reduce tobacco use.
12047983|NCT00218270|Drug|Tobacco free snuff|Tobacco free snuff
12047984|NCT00218257|Drug|Progesterone|200mg progesterone twice daily
12047985|NCT00218257|Other|Placebo|placebo
12047986|NCT00218244|Other|Lower Nicotine Smokeless Tobacco Product|Skoal for 50% reduction;Skoal bandits for 75% reduction.
12047987|NCT00218244|Other|Behavioral Counseling|Behavioral counseling alone for reduction in tobacco use.
12047988|NCT00218231|Drug|300 mg/day bupropion-sr|300 mg/day for 1 week
12047989|NCT00218231|Drug|0 mg/day bupropion-sr|0 mg/day bupropion-sr
12047990|NCT00218218|Drug|Transdermal Nicotine Patch|42 mg transdermal nicotine
12047991|NCT00218218|Drug|21 mg transdermal nicotine|
12047992|NCT00218218|Drug|placebo patch|
12047993|NCT00218205|Drug|Epirubicin|
12047994|NCT00218205|Drug|Estramustine Phosphate|
12047995|NCT00218205|Drug|Celecoxib|
12047996|NCT00218192|Behavioral|Behavior Therapy|
12047997|NCT00218179|Other|Non-intervention|Measured total NNAL and PheT as biomarkers of exposure
12047998|NCT00218166|Drug|GABA Agonists|GABA drugs administered acutely by mouth
12047999|NCT00218153|Drug|Naltrexone|
12048000|NCT00218140|Drug|nicotine transdermal system|
12048001|NCT00218127|Drug|Levoacetyl Methadol|WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
12048002|NCT00218127|Drug|Levoacetyl Methadol|MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
12048003|NCT00218127|Drug|Levoacetyl Methadol|LAAM Fixed Dose evaluation up to 48 mg 48 mg
12048004|NCT00218114|Drug|Divalproex Sodium|Participants are titrated over 2 weeks, as tolerated to 10 mgs / pound, and blood levels are checked to determine that the blood level is between 50-110 micrograms / ml.
12048005|NCT00218114|Drug|Placebo|Participants will be on matching placebo.
12048006|NCT00218101|Drug|Buprenorphine|
12048007|NCT00218075|Drug|Levodopa|
12048008|NCT00218075|Drug|Carbidopa|
12048009|NCT00218075|Behavioral|Clinical Management|
12048010|NCT00218075|Behavioral|Relapse Prevention Therapy|
12048011|NCT00218075|Behavioral|Contingency Management|
12048012|NCT00218062|Drug|D-Amphetamine 30mg|
12048013|NCT00218062|Drug|D-Amphetamine 60mg|
12048014|NCT00218062|Drug|Modafinil 200mg|
12048015|NCT00218062|Drug|Modafinil 400mg|
12048016|NCT00218062|Behavioral|Therapy|Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
12048017|NCT00218062|Drug|Placebo|
12048018|NCT00218049|Drug|GBR 12909|50mg GBR 12909 over 12 days
12048019|NCT00218049|Drug|GBR 12909|GBR 12909 75 mg over 12 day period
12048020|NCT00218049|Drug|GBR 12909|GBR 12909 100 mg over 12 day period
12048021|NCT00218036|Drug|Modafinil 200mg|10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
12048022|NCT00218036|Drug|Modafinil 400mg|10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
12048023|NCT00218036|Drug|Citalopram 20mg|10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
12048024|NCT00218036|Drug|Citalopram 40mg|10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
12048025|NCT00218036|Drug|Placebo|Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
12048026|NCT00218023|Drug|Modafinil|The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase I.
12048027|NCT00218023|Drug|Levodopa/Carbidopa|Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase I.
12048028|NCT00218023|Drug|Naltrexone HCl|Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase I.
12048029|NCT00218023|Drug|Placebo|Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
12048030|NCT00218023|Behavioral|Motivational Interviewing (MI)|The primary goal of motivational interviewing (MI) was to assist patients in achieving initial abstinence by increasing motivation and commitment to change. The MI intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. The client-centered, MI-style sessions focused on building motivation for change, exploring ambivalence, obtaining a commitment to change, making a plan for abstinence (Session 1), providing personalized feedback, reassessing commitment for change, and reevaluating the change plan (Session 2). Masters-level therapists were trained and supervised by the therapy supervisor (ALS), an expert in motivation-based therapies.
12048031|NCT00218023|Behavioral|Contingency management (CM)|Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during phase I) and medication compliance (during phase II).
12048032|NCT00218023|Behavioral|Cognitive-Behavioral Therapy (CBT)|Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. This therapy component focused on coping-skills training for resisting cocaine use in high-risk situations, based on relapse-prevention theory and manual-guided techniques. Therapy sessions were conducted by master's-level licensed professional counselors supervised by a licensed clinical psychologist, who monitored manual adherence and competency.
12048033|NCT00217984|Other|Usual Care|Referral to smoking cessation clinic
12048034|NCT00217984|Behavioral|Extended cognitive behavior therapy|16 sessions of cognitive behavior therapy over 6 months
12048035|NCT00217971|Drug|Dronabinol|Dronabinol
12048036|NCT00217971|Drug|Placebo|placebo
12048037|NCT00217958|Behavioral|SHS reduction intervention based on social cognitive learning theory|
12048038|NCT00217945|Behavioral|Shared-Decision Making|
12048039|NCT00217932|Drug|Divalproex Sodium (Depakote)|
12048106|NCT00217490|Behavioral|dietary counseling via nutritionist|A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
12048107|NCT00217490|Behavioral|combined computer and nutritionist|An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
12048108|NCT00217490|Other|physical activity counseling via computer|An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
12048109|NCT00217477|Drug|gemcitabine hydrochloride|Given IV
12048110|NCT00217477|Drug|paricalcitol|Given IV
12048040|NCT00217919|Behavioral|Health-Counselor Mediated Telephone Counseling Intervention|"A trained health counselor will conduct the TC sessions, which will occur every 6 weeks (total 8 calls). We expect the initial call to last 30 minutes, with subsequent calls lasting 20 minutes. Our intervention for our primary outcome of LDL-C lowering is expected to take most of this time. We will spend approximately 5 minutes addressing physical activity at the end of each session, using methods similar to those in our pilot TC study.
~We will use patient-centered counseling to promote adherence to lipid-lowering medication and LDL-C lowering diet. The intervention will also activate patients to discuss initiation or dose increase of lipid-lowering drugs with their physicians. While the focus of our intervention will be on LDL-C lowering, the TC intervention will also devote approximately 5 minutes of the typical 20 minute call to increasing physical activity."
12048041|NCT00217906|Behavioral|A+ Asthma early intervention program|
12048042|NCT00217893|Behavioral|Counseling|One-on-one behavioral counseling with pre-teen child; 8 to 10 weekly or bi-weekly sessions; focus on identifying sources of exposure to ETS and means to avoid exposure; goal-setting, role-playing, monitoring progress, feedback includes reported info and urine cotinine level.
12048043|NCT00217893|Behavioral|Urine Cotinine Feedback|Urine collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session.
12048044|NCT00217893|Behavioral|Contingent Incentives|Child earns small prizes for on-task behavior in sessions, plus earns tokens redeemable for other prizes based on reduction in ETS exposure (reported and cotinine level).
12048045|NCT00217893|Behavioral|Usual education program|Participants will receive the usual education about ETS.
12048046|NCT00217880|Procedure|Bronchoscopy|A bronchoscopy test will occur to view the participant's airways.
12048047|NCT00217867|Behavioral|Animated character intervention with telephone follow-up|Animated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system.
12048048|NCT00217854|Procedure|Bronchoscopic|Bronchoscopic procedure
12048049|NCT00217841|Drug|Aurograb|
12048050|NCT00217828|Drug|citalopram|
12048051|NCT00217815|Drug|Mycograb, Docetaxel|
12048052|NCT00217802|Behavioral|six-session telephone counseling program|
12048053|NCT00217789|Procedure|Bronchoalveolar Lavage and Venipuncture|
12048054|NCT00217776|Behavioral|Open Airways Educational Intervention|
12048055|NCT00217776|Behavioral|Peer Asthma Action Educational Intervention|
12048056|NCT00217763|Drug|3APS|
12048057|NCT00217737|Biological|Bevacizumab|Given IV
12048058|NCT00217737|Drug|Fluorouracil|Given IV
12048059|NCT00217737|Other|Laboratory Biomarker Analysis|Correlative studies
12048060|NCT00217737|Drug|Leucovorin Calcium|Given IV
12048061|NCT00217737|Drug|Oxaliplatin|Given IV
12048062|NCT00217724|Dietary Supplement|glutamine|Given orally
12048063|NCT00217724|Other|placebo|Given orally
12048064|NCT00217711|Drug|Capecitabine|capecitabine
12048065|NCT00217711|Drug|irinotecan hydrochloride|irinotecan hydrochloride
12048066|NCT00217711|Drug|oxaliplatin|oxaliplatin
12048067|NCT00217698|Drug|cisplatin|
12048068|NCT00217698|Drug|gefitinib|
12048069|NCT00217698|Drug|gemcitabine hydrochloride|
12048070|NCT00217672|Biological|bevacizumab|Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.
12048071|NCT00217672|Drug|Docetaxel|docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
12048072|NCT00217659|Drug|anastrozole|
12048073|NCT00217659|Drug|goserelin acetate|
12048074|NCT00217646|Drug|Sorafenib Tosylate|Given orally
12048075|NCT00217633|Procedure|Conventional Surgery|
12048076|NCT00217620|Drug|sorafenib|800 mg per day, daily until progression
12048077|NCT00217607|Drug|paclitaxel|
12048078|NCT00217594|Drug|Alemtuzumab (Campath)|
12048079|NCT00217581|Biological|Bevacizumab|Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
12048080|NCT00217581|Drug|Docetaxel|Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
12048081|NCT00217581|Drug|Oxaliplatin|Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
12048082|NCT00217568|Biological|pegfilgrastim|
12048083|NCT00217568|Drug|carboplatin|
12048084|NCT00217568|Drug|docetaxel|
12048085|NCT00217555|Drug|gemcitabine hydrochloride|
12048086|NCT00217555|Drug|topotecan hydrochloride|
12048087|NCT00217542|Biological|recombinant interferon alfa-2b|Given SC
12048088|NCT00217542|Drug|amifostine/azacitidine|Given SC
12048089|NCT00217529|Biological|pegfilgrastim|
12048090|NCT00217529|Drug|carboplatin|
12048091|NCT00217529|Drug|docetaxel|
12048092|NCT00217529|Drug|erlotinib hydrochloride|
12048093|NCT00217516|Drug|selenium|Given orally
12048094|NCT00217516|Other|placebo|Given orally
12048095|NCT00217503|Biological|bevacizumab|
12048096|NCT00217503|Biological|filgrastim|
12048097|NCT00217503|Biological|pegfilgrastim|
12048098|NCT00217503|Drug|bortezomib|
12048099|NCT00217503|Drug|cyclophosphamide|
12048100|NCT00217503|Drug|doxorubicin hydrochloride|
12048101|NCT00217503|Drug|etoposide|
12048102|NCT00217503|Drug|ganciclovir|
12048103|NCT00217503|Drug|valganciclovir|
12048104|NCT00217503|Drug|zidovudine|
12048105|NCT00217490|Behavioral|dietary counseling via computer|An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
12048111|NCT00217464|Drug|fulvestrant|intramuscularly
12048112|NCT00217451|Drug|Fosmidomycin-clindamycin|
12048114|NCT00217438|Drug|amifostine trihydrate|Given IV
12048115|NCT00217438|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
12048116|NCT00217438|Genetic|fluorescence in situ hybridization|Correlative study
12048117|NCT00217438|Procedure|bone marrow ablation with stem cell support|Undergo transplant
12048118|NCT00217425|Biological|bevacizumab|"A - CHOP: 15 mg/kg IV infusion once every 21 days for 6-8 cycles. Bevacizumab is to be administered prior to CHOP therapy. Continuous bevacizumab: 15 mg/kg IV infusion once every 21 days.
~Initial dose should be infused over 90 minutes. If no adverse reactions occur, the second dose should be administered over 60 minutes. Again, if no adverse reactions occur, the third and subsequent doses should be administered over 30 minutes. If infusion-related adverse reactions occur, subsequent infusions should be administered over the shortest period that is well-tolerated. Infusions should be run in via a volumetric infusion device. Do NOT administer as an IV push or bolus."
12048119|NCT00217425|Drug|cyclophosphamide|IV infusion per institutional guidelines.
12048120|NCT00217425|Drug|doxorubicin|Intravenously, either as a bolus injection or as a continuous infusion through a central venous line.
12048121|NCT00217425|Drug|prednisone|Prednisone is taken orally.
12048122|NCT00217425|Drug|vincristine|IV push using extravasation precautions.
12048123|NCT00217412|Drug|vorinostat|Given orally
12048124|NCT00217412|Drug|isotretinoin|Given orally
12048125|NCT00217399|Drug|sorafenib tosylate|Given orally
12048126|NCT00217399|Drug|anastrozole|Given orally
12048127|NCT00217386|Biological|anti-thymocyte globulin|
12048128|NCT00217386|Biological|etanercept|
12048129|NCT00217373|Biological|Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine|Given SC
12048130|NCT00217373|Biological|Recombinant Interferon Alfa-2b|Given SC
12048131|NCT00217373|Biological|Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine|Given SC
12048132|NCT00217373|Biological|Sargramostim|Given SC
12048133|NCT00217360|Behavioral|a customised multifactorial falls prevention program|
12048134|NCT00217347|Device|Esophageal Capsule Endoscopy|
12048135|NCT00217334|Behavioral|Volunteer-led pharmacy sessions with feedback to physicians|
12048136|NCT00217308|Drug|Lactobacilli GR-1 and RC-14|Probiotic Lactobacilli will be compared to placebo
12048137|NCT00217295|Drug|Avonex and Topamax|
12048138|NCT00217282|Drug|oxaliplatin, gemcitabine, bevacizumab|"Gemcitabine 1000mg/m2 IV over 30 minutes, on days 1 and 8 followed by Oxaliplatin 130mg/m2 IV over 2 hours on day 1 followed by Bevacizumab 15 mg/kg IV over 90* minutes, on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks. Patients will be re-evaluated every 2 cycles. If CR, PR or SD, patients will continue treatment up to four cycles or until progression or unacceptable toxicity.
~Patients achieving CR, PR, or SD after 4 cycles will continue Bevacizumab maintenance:
~Bevacizumab 15 mg/kg IV q 3 weeks until relapse/progression"
12048139|NCT00217269|Device|Coronary Artery Stenting|Endeavor Drug eluting stent
12048140|NCT00217269|Device|Coronary Artery Stenting|Taxus Drug Eluting Stent
12048141|NCT00217256|Device|Percutaneous Coronary Stenting|Endeavor Drug Eluting Stent
12048142|NCT00217256|Device|Percutaneous Coronary Stenting|Cypher Drug Eluting Stent
12048143|NCT00217243|Other|Evoked fields before and after a local block (Xylocaine)|MEG registration after electrical median and ulnar nerve stimulation in subjects and patients. In the patient group another MEG was performed after an anaesthetic block (1-2 ml Lidocaine 1%) at the site of the nerve injury producing a painfree state
12048144|NCT00217230|Biological|CAIV-T|
12048145|NCT00217217|Device|Echo-Planar Magnetic Resonance Imaging (EP-MRSI)|variable-setting low-frequency MRI
12048146|NCT00217204|Drug|Pancrelipase microtablets|
12048147|NCT00217191|Drug|Ibuprofen|
12048148|NCT00217178|Drug|Vitamins: Folic acid, B6, B12|
12048149|NCT00217165|Drug|taurine|taurine 2mg BID po
12048150|NCT00217152|Drug|CellCept|
12048151|NCT00217139|Drug|Celgosivir|
12048152|NCT00217113|Behavioral|Geriatric home visit and Action Plan|
12048153|NCT00217100|Dietary Supplement|Multivitamin|1 tablet a day
12048154|NCT00217100|Dietary Supplement|Placebo|1 tablet a day
12048155|NCT00217087|Procedure|Endoscopic Mucosal Resection|Endoscopic mucosal resection at time of endoscopy if indicated.
12048156|NCT00217087|Procedure|Photodynamic Therapy|Porfimer sodium 2mg/kg
12048157|NCT00217074|Other|acupuncture|
12048158|NCT00217061|Device|Decision Aid Statin Choice|
12048159|NCT00217048|Drug|Yohimbine, oral|
12048160|NCT00217035|Dietary Supplement|TPN or TPN enriched with glutamine|Each patient undergoes two nutritional support periods either with or without Glutamine supplementation.
12048161|NCT00217022|Other|Placebo|Placebo, 3 tablets daily
12048162|NCT00217022|Drug|Budesonide|9 mg daily (three tablets)
12048163|NCT00217009|Procedure|Narrowband Ultraviolet B (TL-01UVB) Therapy|
12048164|NCT00217009|Procedure|Topical Psoralen plus ultraviolet A (PUVA)|
12048165|NCT00216970|Dietary Supplement|Alteration in nutritional support|The subject is randomized into one of two groups - One receives TPN that does not have arginine, proline or glutamate. The other will receive TPN with extra glutamine. The subject takes part in 3 tracer studies while in the hospital. For each tracer study, the subject will receive a different randomly assigned diet. Blood and air are sampled and the patient receives a stable isotope after which the tests are repeated.
12048166|NCT00216957|Procedure|Coronary bypass surgery without cardiopulmonary bypass|
12048167|NCT00216944|Procedure|Tracheal intubation for respiratory care in preterm infants|Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg
12048168|NCT00216944|Procedure|Tracheal intubation for respiratory care in preterm infants|Premedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg
12048169|NCT00216931|Drug|iloprost|
12048170|NCT00216918|Drug|Atomoxetine Hydrochloride|
12048171|NCT00216892|Drug|Calcipotriol, (calcipotriol + betamethasone)|
12048172|NCT00216879|Drug|Calcipotriol plus betamethasone dipropionate gel (LEO 80185)|
12048173|NCT00216866|Drug|Dalteparin|
12048174|NCT00216866|Drug|Warfarin|
12048175|NCT00216840|Drug|Calcipotriol plus betamethasone dipropionate (LEO80185 gel)|
12048176|NCT00216827|Drug|Calcipotriol plus betamethasone dipropionate (LEO80185 gel)|
12048177|NCT00216788|Drug|Esomeprazole (Nexium) 40 mg/day|
12048178|NCT00216775|Drug|interferon-alfa-2b and ribavirin|
12048179|NCT00216762|Drug|Rituximab|Rituxan ® 1000 mg IV x 2 infusions, 2 weeks apart
12048180|NCT00216736|Drug|Dexamethasone|Single dose oral dexamethasone 8mg at time of ED discharge
12048181|NCT00216736|Drug|placebo|Single dose oral placebo at ED discharge
12048182|NCT00216723|Drug|Aripiprazole|"The recommended starting and target dose for Abilify is 10 or 15mg/day administered on a once-a-day schedule without regard to meals.
~(Administer 10 to 30 mg/day according to the patient's condition)"
12048183|NCT00216710|Behavioral|Home Visiting|
12048184|NCT00216697|Drug|bortezomib|
12048185|NCT00216684|Drug|fentanyl|
12048186|NCT00216671|Drug|early initiation of treatment with Risperdal Consta|25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
12048187|NCT00216671|Drug|routine initiation of treatment with Risperdal Consta|25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
12048188|NCT00216658|Drug|fentanyl|
12048189|NCT00216645|Drug|doxorubicin hydrochloride|
12048190|NCT00216632|Drug|risperidone|
12048191|NCT00216619|Drug|Topiramate|topiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening.
12048192|NCT00216619|Drug|Topiramate - Placebo|the trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26)
12048193|NCT00216606|Drug|topiramate|
12048194|NCT00216593|Drug|galantamine hydrobromide|
12048195|NCT00216580|Drug|Risperidone, long-acting injectable|
12048196|NCT00216567|Drug|topamax|
12048197|NCT00216554|Drug|risperidone|
12048198|NCT00216541|Drug|epoetin alfa|
12048199|NCT00216528|Drug|risperidone|
12048200|NCT00216515|Drug|galantamine hydrobromide|
12048201|NCT00216502|Drug|galantamine hydrobromide|
12048202|NCT00216489|Drug|rabeprazole sodium|
12048203|NCT00216476|Drug|Aripiprazole|10-30 mg oral once daily for 104 weeks
12048204|NCT00216476|Drug|Risperidone Long Acting Injectable (LAI)|25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective.
12048205|NCT00216476|Drug|Quetiapine|Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg.
12048206|NCT00216463|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 200 mg subcutaneous injection - every other week for 11 weeks
12048207|NCT00216463|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 100 mg subcutaneous injection - every other week for 11 weeks
12048208|NCT00216463|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injection - every week for 13 weeks
12048209|NCT00216463|Drug|ISIS 301012 or Placebo|400 mg subcutaneous injection - every week for 13 weeks
12048210|NCT00216463|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection - every week for 13 weeks
12048211|NCT00216450|Drug|rabeprazole sodium|
12048212|NCT00216437|Drug|Capecitabine (Xeloda)|
12048213|NCT00216424|Drug|Capecitabine (Xeloda)|
12048214|NCT00216411|Biological|Botulinum toxin type A|
12048215|NCT00216411|Drug|Placebo|
12048216|NCT00216398|Drug|Lanreotide (Autogel formulation)|
12048217|NCT00216385|Drug|Gatifloxacin combined regimen|
12048218|NCT00216372|Drug|Lanreotide (microparticle formulation)|A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment.
12048219|NCT00216372|Other|Placebo|A single intra-muscular injection on day 0.
12048220|NCT00216359|Drug|Fuzeon (Enfuvirtide)|
12048221|NCT00216359|Procedure|Laboratory diagnostic (CD4-cells)|
12048222|NCT00216359|Procedure|Laboratory diagnostics (HIV-1 viral load)|
12048223|NCT00216359|Drug|antiretroviral co-medication beside Fuzeon|
12048224|NCT00216346|Drug|Paromomycin sulfate|
12048225|NCT00216346|Drug|Amphotericin B|
12048226|NCT00216333|Drug|combined fixed dose combination|
12048227|NCT00216320|Device|WalkAide|Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
12048228|NCT00216320|Device|AFO|Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
12048229|NCT00216320|Device|AFO|Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover
12048230|NCT00216294|Drug|RG1068 (Synthetic Human Secretin)|
12048231|NCT00216281|Drug|Clozapine augmented with atomoxetine up to 40 mg or placebo|
12048232|NCT00216268|Drug|Ribavirin|
12048233|NCT00216255|Drug|Pagoclone|
12048234|NCT00216255|Drug|Placebo|
12048235|NCT00216242|Biological|Influenza virus vaccine (Fluviral)|
12048236|NCT00216242|Biological|Saline placebo|
12048237|NCT00216229|Biological|Combined vaccine against hepatitis A and B (Twinrix)|
12048238|NCT00216216|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV q 3 weeks
12048239|NCT00216203|Drug|Pemetrexed|Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
12048240|NCT00216203|Drug|Cetuximab|"Cetuximab 400 mg/m2, week 1, day 1
~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
12048241|NCT00216190|Drug|Dexmedetomidine HCL Injection|
12048242|NCT00216190|Drug|Midazolam Injection|
12048243|NCT00216177|Drug|Infliximab|Remicade
12048244|NCT00216177|Drug|Adalimumab|Humira
12048245|NCT00216164|Drug|Rituximab|Rituximab 375 mg/m2, day 1 of 21 day cycle
12048246|NCT00216164|Drug|Gemcitabine|Gemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle
12048247|NCT00216151|Drug|Zoledronic Acid|Zoledronic Acid 4mg, every three months
12048248|NCT00216138|Drug|Docetaxel|Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle
12048249|NCT00216138|Drug|Capecitabine|Capecitabine 825 mg/m2 po bid, days 1-14
12048250|NCT00216138|Drug|Premedication|Dexamethasone and antiemetic premedication
12048251|NCT00216125|Drug|Cisplatin|Cisplatin 50 mg/m2 day 1, 8, 29, 36
12048252|NCT00216125|Drug|Etoposide|Etoposide 50 mg/m2, days 1-5, 29-33
12048253|NCT00216125|Radiation|Radiation|Radiation 5940 cGy (180 cGy/day)
12048254|NCT00216125|Drug|Docetaxel|docetaxel 75mg/m2 q3wk x 3 cycles
12048255|NCT00216112|Drug|Imatinib Mesylate|Imatinib mesylate 600 mg po qd
12048256|NCT00216112|Drug|Docetaxel|Docetaxel 30 mg/m2 (4 of 6 weeks); 1 cycle = 6 weeks
12048257|NCT00216099|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
12048258|NCT00216099|Dietary Supplement|Folic Acid|All participants received oral Folic Acid 350-100ug once per day for 7 days preceding the first pemetrexed dose and continuing throughout the study and and for 21 days after the last dose of pemetrexed.
12048259|NCT00216099|Dietary Supplement|Vitamin B12|All patients received vitamin B12 1000ug intramuscular injection the week preceding the first pemetrexed dose and received additional 1000ug intramuscular injections every three cycles thereafter on the same day of pemetrexed administration.
12048260|NCT00216086|Drug|Capecitabine|"Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid"
12048261|NCT00216086|Drug|Irinotecan|Irinotecan 200 mg/m2 IV, day 1
12048262|NCT00216086|Procedure|EUS|biopsy per EUS
12048263|NCT00216086|Drug|Neoadjuvant Chemotherapy|"Irinotecan 200 mg/m2 IV, day 1
~Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles"
12048264|NCT00216086|Procedure|Preoperative Radiation|Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
12048265|NCT00216086|Procedure|Surgery|Surgery within 8 weeks following chemoradiotherapy
12048266|NCT00216086|Procedure|Adjuvant Chemotherapy|Adjuvant chemotherapy at investigator's discretion
12048267|NCT00216073|Drug|Capecitabine|Capecitabine 825 mg/m2 po bid, days 1-14
12048268|NCT00216073|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IV, day 1
12048269|NCT00216073|Drug|Trastuzumab|Trastuzumab 6mg/kg IV, day 1. 8 mg/kg loading dose given in cycle 1 for patients without previous trastuzumab therapy only.
12048270|NCT00216060|Drug|Risedronate|Daily oral risedronate combined with androgen deprivation
12048271|NCT00216060|Drug|Placebo|Daily oral placebo combined with androgen deprivation
12048272|NCT00216047|Drug|PTK787|PTK787 daily
12048273|NCT00216047|Drug|Trastuzumab|Trastuzumab 4 mg/kg IV week 1, followed by 2 mg/kg weekly with disease evaluation every other cycle*
12048274|NCT00216034|Drug|Tegafur-gimeracil-oteracil potassium (TS-1)|From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7
12048275|NCT00216034|Drug|Krestin (PSK)|From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
12048276|NCT00216021|Drug|Capecitabine|Capecitabine 825 mg/m2 po bid, days 1-14
12048277|NCT00216021|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IV, day 1
12048278|NCT00216008|Drug|docetaxel|
12048279|NCT00216008|Drug|cisplatin|
12048280|NCT00216008|Procedure|radiation|
12048281|NCT00216008|Procedure|surgery|
12048282|NCT00215995|Drug|Cisplatin|As outlined in Detailed Description
12048283|NCT00215995|Drug|Irinotecan|As outlined in Detailed Description
12048284|NCT00215995|Drug|ZD 1839|As outlined in Detailed Description
12048285|NCT00215982|Drug|capecitabine|Capecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2. Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle.
12048286|NCT00215982|Drug|Oxaliplatin|Oxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days.
12048287|NCT00215982|Drug|Irinotecan|Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.
12048288|NCT00215956|Drug|topotecan|Preoperative treatment: oral topotecan 5 days per week for up to 5 weeks
12048289|NCT00215956|Procedure|radiation|Preoperative radiation
12048290|NCT00215956|Procedure|surgery|surgery to remove tumor 4 to 8 weeks following completion of preoperative treatment
12048291|NCT00215943|Drug|zoledronic acid|Patients were randomized to receive zoledronic acid I.V. on either Day 1 or 15 of each cycle. This schedule continued monthly as long as the patient remained on study. The dose was calculated based on the patients' monthly creatinine clearance.
12048292|NCT00215943|Drug|dexamethasone|As outlined in VAD Treatment arm and Thalidomide and Dexamethasone Treatment arm
12048293|NCT00215943|Drug|thalidomide|As outlined in Thalidomide and Dexamethasone Treatment arm
12048294|NCT00215943|Drug|vincristine|As outlined in VAD Treatment Arm
12048295|NCT00215943|Drug|adriamycin|As outlined in VAD Treatment arm
12048296|NCT00215930|Drug|Vinorelbine|Ribonucleotide reductase subunit 1(RRM1)above 16.5 and Excision repair cross-complementing group 1 gene(ERCC1)above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days.
12048336|NCT00215579|Drug|Depot Risperidone Microsphere (Consta)|
12048337|NCT00215566|Drug|DDP733|
12048338|NCT00215553|Drug|A.1 Lucinactant|3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL
12048339|NCT00215553|Other|B.3 SoC|Standard ARDS management and ICU care
12048297|NCT00215930|Drug|Docetaxel|"RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days.
~RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days.
~RRM1 above 16.5 and ERCC1 above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days."
12048298|NCT00215930|Drug|Gemcitabine|"Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
~RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days."
12048299|NCT00215930|Drug|Carboplatin|"Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
~RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days."
12048300|NCT00215917|Drug|D-serine 2100 mg daily|
12048301|NCT00215904|Drug|D-serine (~2g/day)|Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (~2g/day). Second arm : adjuvant treatment with placebo (~2g/day).
12048302|NCT00215891|Drug|PEG-Interferon a-2b + Ribavirin|
12048303|NCT00215878|Drug|D-serine (~2g /day)|Two 6 weeks treatment arms under a cross over design. In one arm adjuvant treatment with experimental medication (D-serine ~2g /day), in the second arm adjuvant treatment with placebo (~2g /day)
12048304|NCT00215865|Drug|PEGIntron plus ribavirin|
12048305|NCT00215852|Drug|Alferon LDO|500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.
12048306|NCT00215839|Drug|Peginterferon a-2a plus Ribavirin|
12048307|NCT00215826|Drug|Alferon LDO|
12048308|NCT00215813|Drug|Poly I: Poly C12U (Rintatolimod)|200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
12048309|NCT00215800|Drug|Ampligen|
12048310|NCT00215787|Drug|lansoprazole|Lansoprazole 30 mg BID for 1 year
12048311|NCT00215774|Drug|Flecainide|Flecainide 2 - 3 x 100 mg/d The main difference between the two active therapy groups is the duration of treatment.
12048312|NCT00215748|Drug|Dexamethasone|
12048313|NCT00215735|Device|debridement, dressing, and APC|ebridement, dressing, and APC
12048314|NCT00215722|Drug|Cetuximab|
12048315|NCT00215709|Drug|docetaxel|
12048316|NCT00215696|Genetic|BioBypass®|
12048317|NCT00215683|Drug|Degarelix|Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
12048318|NCT00215670|Drug|pegaptanib sodium (Macugen)|
12048319|NCT00215657|Drug|Degarelix|Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048320|NCT00215657|Drug|Degarelix|Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048321|NCT00215657|Drug|Degarelix|Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048322|NCT00215657|Drug|Degarelix|Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048323|NCT00215657|Drug|Degarelix|Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048324|NCT00215657|Drug|Degarelix|Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048325|NCT00215657|Drug|Degarelix|Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048326|NCT00215657|Drug|Degarelix|Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
12048327|NCT00215644|Drug|Matuzumab|Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
12048328|NCT00215644|Drug|Epirubicin|Participants will receive epirubicin 50 milligrams per square meter (mg/m^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles.
12048329|NCT00215644|Drug|Cisplatin|Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
12048330|NCT00215644|Drug|Capecitabine|Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.
12048331|NCT00215631|Drug|tadalafil|
12048332|NCT00215618|Device|Uterine Balloon Therapy|UBT with post procedure curettage
12048333|NCT00215618|Device|Uterine Balloon Therapy|UBT without post procedure curettage
12048334|NCT00215605|Drug|XL184|Flavored liquid suspension or gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing or intermittent schedule (daily dosing followed by dosing holiday in cycles)
12048335|NCT00215592|Drug|Zonegran|
12048340|NCT00215553|Drug|A.2 Lucinactant|3 30 mL aliquots at a concentration of 10 mg/mL each
12048341|NCT00215553|Drug|A.3 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL
12048342|NCT00215553|Drug|A.4 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
12048343|NCT00215553|Drug|B.1 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL
12048344|NCT00215553|Drug|B.2 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
12048345|NCT00215540|Drug|Lucinactant 175 mg/kg|Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18).
12048346|NCT00215540|Drug|Lucinactant 90 mg/kg|Administered via slow intra-tracheal instillation at a dose of 90 mg/kg (3.0 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).
12048347|NCT00215540|Drug|Placebo|Sham air was administered via slow intratracheal instillation at a dose of 3.0 mL/kg volume of air. The initial treatment was given no later than 1 hour after randomization. Additional treatment were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).
12048348|NCT00215527|Drug|laronidase|0.58 mg/ml solution for intravenous injection, dose 1.74 mg intrathecally once per month for four injections.
12048349|NCT00215514|Drug|Epirubicin|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
12048350|NCT00215514|Drug|Cisplatin|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
12048351|NCT00215514|Drug|5-Fluorouracil (5-FU)|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
12048352|NCT00215514|Procedure|Radiation|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
12048353|NCT00215501|Drug|Capecitabine|Orally twice a day for 14 days (dosage will vary)
12048354|NCT00215501|Drug|5-Fluorouracil (5-FU)|Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary
12048355|NCT00215501|Drug|Irinotecan|Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
12048356|NCT00215501|Drug|Cisplatin|Intravenously weekly for 2 weeks followed by a one week rest period
12048357|NCT00215462|Drug|Vinorelbine|
12048358|NCT00215449|Drug|Formoterol Fumarate|
12048359|NCT00215436|Drug|Formoterol Fumarate|
12048360|NCT00215423|Drug|Formoterol Fumarate|
12048361|NCT00215410|Drug|Formoterol Fumarate|
12048362|NCT00215397|Drug|Formoterol Fumarate|
12048363|NCT00215384|Drug|Formoterol Fumarate|
12048364|NCT00215371|Drug|Formoterol Fumarate|
12048365|NCT00215358|Drug|Formoterol Fumarate|
12048366|NCT00215345|Drug|Taxotere|
12048367|NCT00215345|Drug|Celecoxib|
12048368|NCT00215332|Device|CHARITE|Lumbar Total Disc Replacement
12048369|NCT00215319|Device|Lumbar I/F with cage and pedicle screws|Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
12048370|NCT00215306|Device|CHARITÉ Artificial Disc|
12048371|NCT00215306|Device|Anterior Interbody Fusion with BAK Cage|
12048372|NCT00215293|Device|Cervical I/F Cage|
12048373|NCT00215293|Device|Autograft or allograft with a plate, or autograft alone.|
12048374|NCT00215280|Drug|ivermectin and albendazole|
12048375|NCT00215267|Drug|praziquantel|
12048376|NCT00215254|Drug|quetiapine|
12048377|NCT00215241|Drug|sertraline and risperidone|
12048378|NCT00215228|Drug|duloxetine vs. escitalopram|
12048379|NCT00215215|Device|Vagus Nerve Stimulation Therapy|
12048380|NCT00215202|Drug|Iressa (ZD1839)|
12048381|NCT00215189|Behavioral|In SHAPE (Pilot Health Promotion Intervention)|
12048382|NCT00215176|Drug|modafinil|
12048383|NCT00215163|Drug|Cognitive-behavioral therapy and paroxetine-CR|
12048384|NCT00215150|Drug|Ziprasidone|Sertraline augmentation with ziprasidone
12048385|NCT00215150|Drug|Sertraline|Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
12048386|NCT00215137|Drug|escitalopram|Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.
12048387|NCT00215137|Drug|Placebo ( sugar pill)|Placebo Comparator in double.blind phase.
12048388|NCT00215124|Drug|Filgrastim|
12048389|NCT00215111|Behavioral|Low carbohydrate, reduced glycemic load, and a control diet|
12048390|NCT00215046|Drug|Vinblastine|drug - dosage and frequency is based on size of patient and response to treatment.
12048391|NCT00215046|Drug|Methotrexate|drug - dosage is based on size of patient and frequency and duration is based on response to treatment.
12048392|NCT00215007|Drug|Levofloxacin|
12048393|NCT00214994|Drug|Gabitril|
12048394|NCT00214981|Drug|Modafinil|
12048395|NCT00214968|Drug|Modafinil|maximum dosage 400 mg/day (4 tablets)
12048396|NCT00214955|Drug|ORAVESCENT Fentanyl Citrate|
12048397|NCT00214942|Drug|ORAVESCENT Fentanyl Citrate|
12048398|NCT00214929|Behavioral|treatment at home|
12048399|NCT00214916|Drug|intensive insulin therapy (Actrapid IV to normoglycemia)|intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
12048400|NCT00214916|Drug|conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)|conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
12048401|NCT00214890|Drug|Tenofovir|300 mg once daily
12048402|NCT00214890|Drug|Abacavir|600 mg once daily
12048403|NCT00214877|Drug|Methylene Blue|
12048404|NCT00214864|Drug|docetaxel, capecitabine|cohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8
12048405|NCT00214851|Drug|Kineret (anakinra)|Kineret (anakinra 100 mg. s/c daily x 4 weeks
12048406|NCT00214838|Drug|Atiprimod|
12048407|NCT00214825|Drug|eplerenone|50 mg daily for 6 weeks with placebo
12048408|NCT00214825|Drug|Hydrochlorothiazide|HCTZ 12.5 mg with potassium (10 mEq) daily for 6 weeks
12048409|NCT00214812|Drug|HEC placebo gel|
12048410|NCT00214786|Biological|Islet cell transplantation|Allogenic islet transplantation
12048411|NCT00214760|Device|PGET|resolbable liner
12048412|NCT00214760|Device|PMMA|cement liner
12048413|NCT00214747|Drug|Vehicle gel formulations|
12048414|NCT00214734|Drug|rAHF-PFM|
12048415|NCT00214721|Drug|Experimental Peritoneal Dialysis Solution|
12048416|NCT00214708|Procedure|Screening for Tuberculosis|
12048417|NCT00214695|Drug|Experimental Peritoneal Dialysis Solution|
12048418|NCT00214682|Drug|Folate (400mcg) and Vitamin B12 (100 mcg)|The vitamin intervention was a daily oral dose of one tablet consisting of folic acid 400 mcg + vitamin B12 100 mcg. The folic acid dose of 400 mcg / day was selected as it has been shown to be the dose associated with 90% of the maximal decrease in plasma homocysteine concentration for older individuals. Participants received 1 bottle x 200 tablets in six-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months).
12048419|NCT00214682|Behavioral|mediated physical activity promotion|Individuals in the Physical Activity Promotion group received a manual designed to promote older individuals' physical activity participation to the level recommended to gain both physical and mental health benefits. The framework of the physical activity manual was informed by social cognitive theory and the transtheoretical model, and comprised five sections that reflect stages of behaviour change, including; precontemplation, contemplation, preparation, action, and maintenance. The manual contained evidence-based strategies and skills to assist people in increasing their physical activity levels. Participants received a pedometer at the commencement of the intervention as pedometry step / minute values are useful as an indicator of moderate to vigorous physical activity with total number of steps for one week recorded during the brief telephone calls at 1-5 weeks, and 4-, 8-, 13-, 18-, and 22- months.
12048420|NCT00214682|Behavioral|Mental health literacy|Comprises 10 modules, with nine of these specifically written for older adults. Modules 1 to 5 comprised information on depression and the evidence-based treatment for older adults. The additional MHL modules were booklets addressing evidence-based strategies and treatments for depression. It was delivered in a way to foster support and ensure that participants worked through the material systematically. Modules 1 to 5 were delivered in consecutive weeks as previous research indicates that the maximum impact of MHL on depressive symptoms may occur within the first six weeks of the intervention. Telephone interviewers contacted participants once a week for 5 consecutive weeks to motivate and support participants. There were an additional 5 check-in telephone calls, and Modules 6 to 10 of the MHL material that were delivered via postal mail at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10).
12048421|NCT00214682|Drug|placebo|A placebo tablet was the attention control intervention for the folic acid + vitamin B12 intervention group. Participants received 1 bottle x 200 tablets in 6-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months) during which participants counted their left-over tablets.
12048422|NCT00214682|Behavioral|Nutrition information|The attention control intervention for the physical activity intervention was printed nutrition literacy and included information concerning the recommended dietary guidelines for older Australians, as well as strategies and additional information to facilitate beneficial dietary behaviours. The same procedure was adhered to as the physical activity intervention to ensure adequate attention control. Participants in the nutrition promotion intervention received 5 brief telephone calls from an interviewer to facilitate adherence to the intervention, and to offer support and clarification of the materials. Participants received five further brief telephone calls as well as nutrition newsletters that were delivered via postal mail at 4-, 8-, 13-, 18-, and 22- months.
12048423|NCT00214682|Behavioral|pain and arthritis management information|Pain and Arthritis Information was used as the attention control intervention for the MHL intervention and comprised 10 modules. Modules 1 to 5 were contained in an Arthritis Australia consumer guide for arthritis management. Modules 6 to 10 were a series of information pamphlets on pain management, osteoporosis and falls prevention. The delivery of the Pain Information was identical to the MHL intervention with Modules 1 to 5 distributed via postal mail in five consecutive weeks (1-5 weeks), while the remaining intervention modules were delivered at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10). Participants also received 10 brief calls from a telephone interviewer that coincided with receiving the print intervention materials.
12048424|NCT00214669|Behavioral|PACE (Professional Asthma Care Education)|Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
12048425|NCT00214669|Behavioral|Lay Led Expert Patient Programme|Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Stanford University's chronic disease self-management programme.
12048426|NCT00214669|Behavioral|Asthma self management education by a specialist nurse|asthma education and self management, asthma action plans
12048427|NCT00214656|Drug|Recombinant Activated Factor VII|
12048428|NCT00214643|Drug|Fosmidomycin|30 mg/kg
12048429|NCT00214643|Drug|clindamycin|10 mg/kg
12048430|NCT00214630|Drug|rosuvastatin calcium|
12048431|NCT00214630|Drug|atorvastatin|
12048432|NCT00214617|Drug|Rosuvastatin at 5 mg/day and 40 mg/day|
12048433|NCT00214604|Drug|Rosuvastatin|10mg
12048434|NCT00214604|Drug|rosuvastatin|20mg
12048435|NCT00214604|Drug|pravastatin|40mg
12048436|NCT00214591|Drug|GALIDA|
12048437|NCT00214578|Drug|Seroquel (quetiapine)|
12048438|NCT00214565|Drug|Galida|
12048439|NCT00214552|Drug|rabeprazole|
12048440|NCT00214539|Procedure|Bronchial Thermoplasty with the Alair System|Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day.
12048441|NCT00214539|Drug|Control|Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.
12048442|NCT00214526|Procedure|Bronchial thermoplasty with the Alair System|Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.
12048443|NCT00214526|Drug|Conventional therapy with ICS+LABA|Conventional therapy with ICS+LABA.
12048444|NCT00214513|Behavioral|Home-based exercise training|
12048445|NCT00214500|Drug|migalastat HCl|
12048446|NCT00214487|Device|Bifocal Contact Lenses|Use of bifocal contact lenses of varying add powers to control the progression of myopia
12048447|NCT00214487|Device|Placebo Control|Single vision soft contact lenses
12048448|NCT00214474|Behavioral|ATSM Intervention|Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months). Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.
12048449|NCT00214474|Behavioral|GMV Intervention|GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.
12048450|NCT00214461|Biological|Vaccine diluent buffer (Placebo)|0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
12048451|NCT00214461|Biological|C. difficile toxoid vaccine (2 µg)|0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
12048452|NCT00214461|Biological|C. difficile toxoid vaccine (10 µg)|0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
12048453|NCT00214461|Biological|C. difficile toxoid vaccine (50 µg)|0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
12048454|NCT00214435|Drug|once daily minimum 3-drug regimen of anti-retroviral medications|
12048455|NCT00214422|Radiation|Radiation|Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
12048456|NCT00214383|Behavioral|CHESS Internet telehealth|CHESS Internet telehealth
12048457|NCT00214370|Drug|Propofol-Fentanyl|
12048458|NCT00214370|Drug|Propofol alone|
12048459|NCT00214357|Behavioral|Mindfulness-based stress reduction|
12048460|NCT00214344|Behavioral|family preparation for withdrawing life support|
12048461|NCT00214331|Drug|ciprofloxacin|ciprofloxacin 500 mg twice a day for five doses.
12048462|NCT00214331|Drug|azithromycin|azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
12048463|NCT00214331|Drug|gentamicin|a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes
12048464|NCT00214318|Drug|Terbutaline plus Metoprolol or carvedilol|
12048465|NCT00214305|Behavioral|Range of Motion Therapy Program|The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.
12048466|NCT00214305|Behavioral|Postural Sensory Therapy Program|The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.
12048467|NCT00214292|Procedure|fluorescence spectroscopy and diffuse spectroscopy|
12048468|NCT00214279|Drug|Corticosteroid withdrawal|prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus
12048469|NCT00214266|Drug|Campath 1H®, Rituximab, mycophenolate mofetil|Induction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid
12048470|NCT00214253|Drug|Thiazolidinedione|Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
12048471|NCT00214240|Drug|CMV Immune globulin|CMV IvIg 150mg/kg x 6 doses
12048472|NCT00214214|Drug|Campath 1H® (Alemtuzumab)|
12048473|NCT00214201|Drug|Calcineurin inhibitor withdrawal|stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
12048474|NCT00214162|Behavioral|Comprehensive Health Enhancement Support System|Full CHESS
12048475|NCT00214162|Behavioral|computer with internet|computer with internet use x 1 year
12048476|NCT00214149|Radiation|brachytherapy|breast brachytherapy to 34 Gy
12048477|NCT00214136|Radiation|radiotherapy|prostate radiation to 70Gy; nodal radiation to 56Gy
12048478|NCT00214123|Radiation|radiation therapy (radiotherapy)|Bin assignment based on tumor volume
12048479|NCT00214110|Drug|Tamoxifen|
12048480|NCT00214097|Radiation|Radiotherapy|Daily radiation to prescribed dose
12048481|NCT00214084|Drug|Allopurinol|
12048482|NCT00214071|Biological|Influenza vaccine|
12048483|NCT00214058|Drug|Carboplatin|
12048484|NCT00214058|Drug|Docetaxel|
12048485|NCT00214045|Device|Flexible Cystoscopy|
12048486|NCT00214045|Device|Rigid Cystoscopy|
12048487|NCT00214032|Drug|Pycnogenol|pycnogenol 300 mg daily
12048488|NCT00214032|Drug|Placebo|placebo 3 capsules daily
12048489|NCT00214019|Drug|salmeterol|salmeterol diskus 50 mcg twice per day
12048490|NCT00214019|Drug|Fluticasone|placebo diskus, fluticasone MDI 88 mcg twice per day
12048491|NCT00214019|Drug|Placebo|placebo diskus
12048492|NCT00213993|Drug|antiperspirant|antiperspirant topically once daily to one foot
12048493|NCT00213980|Drug|Zoledronate|4 mg IV over 15 minutes administered once every 12 weeks times 4
12048494|NCT00213967|Device|22 gauge 1 1/2 inch needles on a 3 ml syringe|cold needles or needles kept at room temperature
12048495|NCT00213954|Procedure|ultrasound-guidance with echography|Locoregional anesthesia with or without ultrasound guidance practice
12048496|NCT00213941|Device|Echocardiography|
12048497|NCT00213928|Drug|Horse Chestnut Seed Extract|Control (no intervention) vs Horse Chestnut Seed Extract
12048587|NCT00212719|Drug|ONO-5920|
12048498|NCT00213915|Drug|12 g of L-arginine glutamate during 6 weeks twice a day|
12048499|NCT00213889|Other|None: molecular genetics diagnosis procedure only|None: molecular genetics diagnosis procedure only
12048500|NCT00213863|Device|Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting|The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting.
12048501|NCT00213850|Procedure|EFR|
12048502|NCT00213837|Device|Mandibular prosthesis made of a new highly biointegratable material|Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated.
12048503|NCT00213811|Behavioral|clinical, biological, and radiological|
12048504|NCT00213798|Procedure|Biopsy samples|
12048505|NCT00213759|Drug|filgrastim|The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%.
12048506|NCT00213759|Drug|dextrose 5%|The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes.
12048507|NCT00213694|Drug|docetaxel and celecoxib|
12048508|NCT00213681|Device|Boussignac CPAP - bilevel ventilation support|
12048509|NCT00213668|Dietary Supplement|glutamine (dipeptiven)|
12048510|NCT00213655|Biological|bladder tumor recurrence|bladder tumor recurrence assessed by clinical and biological exams
12048511|NCT00213629|Other|transcriptome analysis|transcriptome analysis from muscle biopsy
12048512|NCT00213629|Other|T cell repertoire analysis|blood T cell repertoire analysis
12048513|NCT00213616|Procedure|surgical reinnervation|laryngeal reinnervation with a phrenic nerve root
12048514|NCT00213590|Drug|cyclosporine A|The usual-exposure level was based on the mean area-under-the-concentration-time curve (AUC0-12h). In the usual-exposure group, the cyclosporine AUC0-12h target was 4.3 (3.5 to 4.8, range) mg•h/L and in the low-exposure group the target was 50% or 2.2 (2.0 to 2.6, range) mg•h/L. Ranges were asymmetrical for safety reasons, i.e., to prevent the occurrence of rejection in the low-exposure arm and nephrotoxicity in the usual-exposure arm.The AUC 0-12h was estimated using a Bayesian estimator and a three-point limited sampling strategy (0, 1, and 3 hours). A computer program was used to calculate the dose adjustment required to reach the therapeutic target. Doses were adjusted in increments of 25% to reach the target within 2 months. Cyclosporine AUC0-12h was determined every 2 months.
12048515|NCT00213577|Drug|type A botulinum toxin|
12048516|NCT00213564|Drug|response to infliximab associated with methotrexate|
12048517|NCT00213551|Drug|Glutamine|
12048518|NCT00213551|Drug|Glucose|
12048519|NCT00213551|Drug|glutamine-antioxidants containing solution|
12048520|NCT00213538|Drug|Response to anakinra associated with methotrexate|
12048521|NCT00213525|Other|Questionnary for environmental factors research|Questionnary for environmental factors research
12048522|NCT00213512|Drug|Mabthera|
12048523|NCT00213499|Procedure|non invasive ventilation|
12048524|NCT00213486|Drug|irinotecan|
12048525|NCT00213434|Device|Herbst oral appliance|
12048526|NCT00213421|Drug|Dermoval|group 1 elevated corticosteroids : attack treatment 2 tubes of 10g (4t/d) decreasing treatment : one month: 2 tubes/J (2t/d); 2 months : 2 tubes 1d sur 2 (1d/j); 4 months : 2 tubes 2 fois /week (0,6t/d); 4 months : 2 tubes 1 fois /week (0,3t/d)fois /week (0,3t/d) group 2 low corticosteroids : for paucibullous form with weight < 45kg attack treatment 1 tubes of 10g (1t/d)decreasing treatment 1 month : 1 tube every 2d (0,5t/d; 1 month : 1 tubes 2 fois /week (0,3t/d) 1 month : 1 tubes 1 fois/week (0,15t/d); for paucibullous form with weight > 45kg or for multibullous form with weight < 45kg attack treatment 2 tubes of 10g (2t/d)decreasing treatment 1 month : 2 tubes every 2j (1t/d; 1 month : 2 tubes 2 fois /week (0,6t/d) 1 month : 2 tubes 1 fois /week (0,3t/d)and for multibullous form attack with weigth > 45kg treatment 3 tubes of 10g (3t/d)decreasing treatment 1 month : 3 tubes every 2days (1,5t/d) 1 month : 3 tubes 2 fois /week (1t/j)1 mois : 3 tubes 1 fois /week (0,45t/d)
12048527|NCT00213408|Procedure|Radiofrequency catheter ablation of typical atrial flutter|
12048528|NCT00213395|Device|Interface for noninvasive ventilation|
12048529|NCT00213330|Procedure|rectal distension|
12048530|NCT00213317|Procedure|lombo-sacral magnetic stimulation|repetitive lombo-sacral nerve magnetic stimulation active and placebo performed during colonic recordings after bisacodyl instillation
12048531|NCT00213304|Biological|varicella vaccine (VARIVAX)|
12048532|NCT00213291|Drug|darbepoetin alfa|Darbepoetin alfa will be administered by SC/IV injection every 14-28 days. Patients starting on the 14 day dose regimen will receive two times their baseline weekly dose; patients on the 28 day schedule will receive four times their average weekly dose. The exception to a Q14 or Q28 dosing schedule will be for patients requiring 10 mcg every 10 days. These patients will go to 20 mcg Q21 days before extending to the Q28 day schedule. Naive patients will start on a dose of 0.9 mcg/kg every 14 days. Study subjects who are successfully treated for 12 weeks on the 14 day schedule may be enrolled in the 28 day schedule study.
12048533|NCT00213278|Drug|vinblastine sulphate injection|Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.
12048534|NCT00213265|Biological|7-valent pneumococcal conjugate vaccine|For transplant patients, vaccination will be started at 4 months or greater after transplantation. The second dose will be given 8 weks following the frist, the third dose 8 weeks after the second, and the fourth will be given 8 weeks after the third.
12048588|NCT00212706|Drug|ONO-8025 (KRP-197)|
12048589|NCT00212693|Drug|ONO-2506PO|
12048590|NCT00212680|Drug|ONO-1101|
12048591|NCT00212667|Drug|ONO-5920|
12048592|NCT00212654|Drug|ONO-1101|
12048593|NCT00212641|Drug|ONO-5129|
12048535|NCT00213265|Biological|Pneumococcal 7-valent Conjugate Vaccine|"Healthy infants: The Prevnar schedule for healthy infants consists of 3 doses of 0.5 ml each, at approximately 2 month intervals, followed by a fourth dose of 0.5 ml at 12-15 months of age (i.e., 2, 4, 6, and 12-15 months)
~Previously unvaccinated older infants and children, who are beyond the age of the routine infant schedule, should receive the follwong schedule:
~7-11 months of age: 3 doses (2 doses at least 4 weeks apart with the third dose after the first birthday and separated from the second dose by at least two months)
~12-23 months of age: 2 doses (at least 2 months apart)
~≥24 months through 9 years of age: 1 dose"
12048536|NCT00213252|Drug|Montelukast plus prednisolone|Single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast
12048537|NCT00213252|Drug|Prednisolone|Six daily doses of oral prednisolone
12048538|NCT00213239|Drug|Remifentanil|The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
12048539|NCT00213239|Drug|Remifentanil|The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
12048540|NCT00213226|Drug|dexamethasone|
12048541|NCT00213213|Drug|Sucrose|
12048542|NCT00213200|Drug|morphine, amethocaine|
12048543|NCT00213187|Behavioral|Aerobic and Qi gong Exercise|
12048544|NCT00213174|Behavioral|school playgrounds|
12048545|NCT00213161|Drug|iron supplement, iron drops|
12048546|NCT00213148|Drug|Anastrozole 1 mg|Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
12048547|NCT00213148|Drug|Anastrozole 5 mg|Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
12048548|NCT00213148|Drug|Anastrozole 10 mg|Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
12048549|NCT00213148|Drug|Clomiphene Citrate 50 mg|Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
12048550|NCT00213148|Drug|Clomiphene Citrate 100 mg|Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).
12048551|NCT00213135|Drug|Cladribine 5.25 mg/kg|Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
12048552|NCT00213135|Drug|Cladribine 3.5 mg/kg|Cladribine tablet will be administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 48, and 52 and placebo matched to cladribine tablet will be administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
12048553|NCT00213135|Other|Placebo|Placebo matched to cladribine tablet will be administered over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
12048554|NCT00213122|Drug|miglitol|
12048555|NCT00213109|Drug|Miglitol|
12048556|NCT00213096|Drug|Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive|
12048557|NCT00213083|Drug|Carraguard (PC-515)|
12048558|NCT00213070|Drug|Miglitol|
12048559|NCT00213057|Drug|Carraguard (PC-515)|
12048560|NCT00213044|Drug|Carraguard (PC-515)|
12048561|NCT00213031|Drug|Carraguard (PC-515)|
12048562|NCT00213018|Drug|Carraguard (PC-515)|
12048563|NCT00213005|Drug|Carraguard (PC-515)|
12048564|NCT00212992|Procedure|fixed versus escalating biphasic defibrillation|
12048565|NCT00212979|Other|non intervention study|
12048566|NCT00212953|Procedure|Advanced Life Support|
12048567|NCT00212940|Behavioral|Supportive Therapy for Adherence to ART (behavior)|
12048568|NCT00212914|Behavioral|Reminder letter|
12048569|NCT00212901|Drug|High dose ACE-I vs ARB|
12048570|NCT00212888|Biological|Remune and ALVAC|"Group 1) Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20);
~Group 2) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20; or
~Group 3) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20."
12048571|NCT00212875|Drug|epoetin alfa|
12048572|NCT00212862|Other|Patients with chemotherapy induced anemia|Physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the database. Patients will have to fill the questionaire at the time of enrollment and baseline.
12048573|NCT00212836|Drug|asenapine|5-10 mg sublingually twice daily for 26 weeks
12048574|NCT00212836|Drug|olanzapine|5-20 mg by mouth once daily for 26 weeks
12048575|NCT00212823|Drug|almotriptan malate|
12048576|NCT00212810|Drug|Topiramate|
12048577|NCT00212797|Drug|Org 34517|low dose Org 34517
12048578|NCT00212797|Drug|Org 34517|high dose Org 34517
12048579|NCT00212797|Drug|Placebo|placebo
12048580|NCT00212784|Drug|asenapine|Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
12048581|NCT00212784|Drug|olanzapine|Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily
12048582|NCT00212771|Drug|asenapine|Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
12048583|NCT00212771|Drug|olanzapine|Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.
12048584|NCT00212758|Drug|Nutropin AQ|Nutropin AQ
12048585|NCT00212745|Behavioral|Andrews/Reiter behavioral treatment for epilepsy|The behavioral intervention in this study uses lifestyle counseling to avoid triggers for seizures and strategies to stop beginning seizures. Participants are taught to practice meditative relaxation exercises.
12048586|NCT00212732|Drug|ONO-8025 (KRP-197)|
12048594|NCT00212628|Drug|Minodronic acid hydrate|
12048595|NCT00212615|Drug|Oxaliplatin (Eloxatin)|
12048596|NCT00212615|Drug|Capecitabine (Xeloda)|
12048597|NCT00212602|Drug|ONO-7436|
12048598|NCT00212589|Drug|Capecitabine|
12048599|NCT00212589|Drug|Fluorouracil + folinic acid|
12048600|NCT00212576|Behavioral|Video Interaction Project|While waiting to see the primary care provider for well child care, the family meets with a child development specialist, who videotapes the parent and infant interacting together. The videotape is then rewound and watched together by the parent and child development specialist. This leads to a discussion about child development, infant cues and parenting, with the child development specialist building on observed strengths in the interaction. In addition, families are provided with parenting pamphlets developed for the project, and with inexpensive developmentally stimulating toys.
12048601|NCT00212576|Behavioral|Building Blocks Project|This project employs a public health approach to facilitate parental engagement in child development. Families are sent monthly newsletters that focus on child development, infant cues and parenting; included with each newsletter is an inexpensive, developmentally stimulating toy. In addition, families periodically receive Ages and Stages Questionnaires, which they complete and mail back to the program. Based on the questionnaires, the program determines whether the infant has screened positive for possible developmental delay and provides this information to both the family and the primary care provider.
12048602|NCT00212550|Procedure|Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.|Sputum induction
12048603|NCT00212498|Procedure|Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies|Blood sample
12048604|NCT00212485|Procedure|Power Doppler Sonography|Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.
12048605|NCT00212485|Procedure|MRI|Magnetic Resonance Imaging with intravenous gadolinium contrast will be done using a standardized protocol, including a spin echo T2 weighted image and gradient echo images.
12048606|NCT00212472|Drug|Factor VIII concentrates|To be determined at the discretion of the investigator.
12048607|NCT00212472|Other|Low-dose treatment|50 FVIII u/kg three times a week.
12048608|NCT00212472|Other|High-dose treatment|200 FVIII u/kg per day.
12048609|NCT00212459|Behavioral|Counseling|Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.
12048610|NCT00212459|Behavioral|Control|No more contacts are made with control patients after the initial counseling session.
12048611|NCT00212446|Device|Electrical Intervention (EI)|Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
12048612|NCT00212433|Drug|Tagitol V, Lo So, Readi-Cat 2|
12048613|NCT00212420|Procedure|parenteral nutrition; enteral nutrition|
12048614|NCT00212407|Biological|Umbilical Cord Blood Transplantation|
12048615|NCT00212381|Drug|di indolylmethane (DIM)|This is the agent being studies. Similar agents have been reported to have potential activity.
12048616|NCT00212381|Dietary Supplement|Red rice bran|"this will act as the active comparator. The sponsor provided this as the placebo arm since it is a filler component of their DIM capsules"
12048617|NCT00212368|Drug|Zinc acetate|
12048618|NCT00212355|Drug|NPC-02|zinc acetate
12048619|NCT00212342|Drug|Norethisterone,Ethinylestradiol|
12048620|NCT00212342|Drug|Sugar pill|
12048621|NCT00212329|Procedure|T Cell Proliferation and Autoreactivity Assays|
12048622|NCT00212329|Procedure|Cellular Immunoblot Assays|
12048623|NCT00212329|Procedure|Tetramer Studies|
12048624|NCT00212329|Procedure|Cytokine ELISPOT|
12048625|NCT00212316|Drug|sodium phenylbutyrate|
12048626|NCT00212303|Behavioral|Exercise training for 6 months|Exercise 3 times/week for 6 months. Exercise consists of aerobic and resistance exercise
12048627|NCT00212290|Drug|pioglitazone|
12048628|NCT00212290|Drug|nateglinide|
12048629|NCT00212290|Drug|placebo|
12048630|NCT00212277|Drug|Norethindrone,Ethinyl Estradiol|
12048631|NCT00212264|Behavioral|Behavioral Therapy|Pelvic Floor Muscle Exercises and Bladder control strategies
12048632|NCT00212264|Device|Pelvic Floor Electrical Stimulation|Pelvic Floor Electrical Stimulation daily for 8 weeks
12048633|NCT00212264|Behavioral|Biofeedback|Pelvic Floor Muscle training via biofeedback
12048634|NCT00212264|Other|No Treatment|No treatment
12048635|NCT00212251|Behavioral|moderate exercise and healthy, low-fat diet|
12048636|NCT00212238|Behavioral|internet behavioral weight loss program|
12048637|NCT00212212|Dietary Supplement|selenium|200 µg selenium as selenate
12048638|NCT00212212|Dietary Supplement|selenium|400 µg selenium as selenate
12048639|NCT00212212|Dietary Supplement|selenium|200 µg selenium as selenomethionine
12048640|NCT00212212|Dietary Supplement|placebo|placebo tablet
12048641|NCT00212199|Drug|orlistat|
12048642|NCT00212199|Behavioral|Brief cognitive behavioral counseling|
12048643|NCT00212186|Drug|Selenium Supplements (essential nutrient)|
12048644|NCT00212173|Drug|Sibutramine|
12048645|NCT00212173|Dietary Supplement|Slim Fast|
12048646|NCT00212160|Procedure|omentectomy|RYGB with omentectomy
12048647|NCT00212147|Drug|general anesthesia|anesthesia regimen with nitrous oxide or without nitrous oxide
12048648|NCT00212134|Device|Contact lens correction of aphakia|optical correction of infant surgical aphakia with Contact lens
12048649|NCT00212134|Device|Intraocular lens implantation|optical correction of surgical aphakia with intraocular lens
12048650|NCT00212121|Radiation|high dose boost|high dose boost
12048651|NCT00212121|Procedure|boost|low dose versus high dose
12048703|NCT00211679|Drug|Botulinum Toxin Type A|
12048704|NCT00211666|Behavioral|Nurse management, home blood pressure monitors, and a chronic disease self management course.|
12048652|NCT00212108|Drug|celecoxib, gefitinib|The dose of ZD1839 to be administered is 250mg. ZD1839 will be taken once daily in the morning at approximately the same time each day. If the patient inadvertently did not take the dose in the morning, the patient may take that dose anytime up to 10pm that same day. The daily treatment will be resumed the next day at the scheduled morning dose. Celecoxib will be administered at 400 mg bd.
12048653|NCT00212095|Drug|docetaxel and ketoconazole|"Docetaxel will be obtained locally from the manufacturer. Storage conditions for unopened vials, reconstitution, and storage conditions for the reconstituted solution will follow the manufacturer's recommendations. Docetaxel solutions should be prepared and stored in glass, polypropylene or polyolefin containers. Non-PVC containing and polyethylene-lined administration sets should be used.
~Ketoconazole is available commercially in 200 mg tablet. Ketoconazole is to be administered at a dose of 200mg BID orally for six doses, starting two days before docetaxel administration. The fifth dose should be administered on the day of and before administering docetaxel, while the sixth dose should be administered in the evening of the day of docetaxel administration."
12048654|NCT00212082|Drug|doxorubicin, docetaxel|
12048655|NCT00212069|Drug|gemcitabine, carboplatin|
12048656|NCT00212056|Drug|ANP(hANP)|0∙025 μg/kg per min for 3 days(intravenous)
12048657|NCT00212056|Drug|Control|placebo
12048658|NCT00212043|Drug|carboplatin and gemcitabine|
12048659|NCT00212030|Drug|nicorandil|(0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion
12048660|NCT00212030|Drug|placebo|Control
12048661|NCT00212017|Drug|voglibose|
12048662|NCT00212017|Behavioral|diet and exercise therapy|
12048663|NCT00212004|Drug|pioglitazone|
12048664|NCT00212004|Other|control|
12048665|NCT00211991|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate|
12048666|NCT00211978|Drug|calcium acetate|667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)
12048667|NCT00211978|Drug|placebo|gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)
12048668|NCT00211965|Biological|S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate|single IM dose of 200 mcg total conjugate
12048669|NCT00211965|Biological|placebo|single dose IM
12048670|NCT00211952|Drug|celecoxib|
12048671|NCT00211939|Drug|calcium acetate|667 mg gelcap, 2-4 t.i.d titrated to serum phosphorus level
12048672|NCT00211939|Drug|sevelamer|1-3 tablets t.i.d, titrated to serum phosphorus level
12048673|NCT00211939|Drug|atorvastatin|20 mg PO qD (in PhosLo group), or held until D60 (sevelamer group); titrate by LDL levels and liver function tests
12048674|NCT00211926|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate|single dose of vaccine containing 100 mcg of each serotype conjugate
12048675|NCT00211926|Biological|placebo|single dose of placebo
12048676|NCT00211913|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate|single IM dose totalling 200 mcg of conjugate
12048677|NCT00211913|Biological|placebo|single IM dose
12048678|NCT00211900|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine|single IM dose totalling 200 mcg of conjugate
12048679|NCT00211887|Drug|Interferon beta 1-a|The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
12048680|NCT00211887|Drug|glatiramer acetate|The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
12048681|NCT00211887|Other|placebo|an inactive substance
12048682|NCT00211874|Behavioral|Nurse-management|bilingual nurses counseled patients on diet, medication adherence, and self-management of symptoms through an initial visit and regularly scheduled follow-up telephone calls and facilitated evidence-based changes to medications in discussions with patients' clinicians.
12048683|NCT00211848|Drug|Polyenylphosphatidylcholine (PPC)|
12048684|NCT00211848|Drug|Pegylated Interferon|
12048685|NCT00211848|Drug|Ribavirin|
12048686|NCT00211835|Behavioral|Cognitive behavioral therapy|Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
12048687|NCT00211835|Behavioral|Supportive psychotherapy|A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.
12048688|NCT00211822|Procedure|fMRI|fMRI
12048689|NCT00211809|Behavioral|Cognitive Behavioral Therapy|standard psychiatric evaluation
12048690|NCT00211809|Drug|Venlafaxine|start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
12048691|NCT00211796|Drug|Divalproex Sodium ER|
12048692|NCT00211783|Procedure|fMRI|there is no intervention
12048693|NCT00211770|Behavioral|Behavioral Assessment|functional behavioral assessments are conducted at two separate visits for each subject.
12048694|NCT00211757|Drug|Divalproex sodium|Study drug.
12048695|NCT00211757|Drug|Placebo|Placebo comparator.
12048696|NCT00211744|Drug|topiramate|
12048697|NCT00211731|Behavioral|Chronic Disease Self Management Course|
12048698|NCT00211718|Drug|intra-articular botulinum toxin type a|
12048699|NCT00211705|Behavioral|Diet|
12048700|NCT00211705|Drug|Diet+pravastatin|
12048701|NCT00211692|Drug|consensus interferon (Interferon Alfacon-1) and ribavirin|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)
12048702|NCT00211692|Drug|Consensus Interferon alfa (CIFN) and ribavirin|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)
12048706|NCT00211627|Device|KEEPASLEEP enhanced breathing device|
12048707|NCT00211614|Drug|Lansoprazole|
12048708|NCT00211601|Behavioral|Disease Management Assessment|
12048709|NCT00211588|Drug|galantamine|
12048710|NCT00211575|Behavioral|Disease Management Assessment|
12048711|NCT00211562|Drug|Olanzapine, Omega 3, Vitamin E+C|No adverse event nor SAE noted.
12048712|NCT00211549|Drug|IDEA-033|
12048713|NCT00211536|Drug|Medtronic MiniMed Implantable Pump Human Recombinant Insulin|400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
12048714|NCT00211536|Device|Medtronic MiniMed Implantable Pump System|The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.
12048715|NCT00211536|Drug|Aventis HOE21PH U400|400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
12048716|NCT00211523|Drug|MBI 226 Acne Solutions|
12048717|NCT00211510|Device|Paradigm 722 sensor augmented pump|Subjects use the Paradigm 722 sensor augmented pump
12048718|NCT00211510|Device|Paradigm 715 insulin pump|Subjects use the Paradigm 715 insulin pump
12048719|NCT00211497|Drug|MBI 226 Acne Solutions|
12048720|NCT00211484|Drug|Anecortave Acetate|
12048721|NCT00211471|Drug|anecortave acetate|
12048722|NCT00211458|Drug|Anecortave Acetate Sterile Suspension (15 mg)|
12048723|NCT00211445|Procedure|Photodynamic Therapy with Verteporfin|
12048724|NCT00211445|Drug|verteporfin|
12048725|NCT00211432|Drug|Anecortave Acetate Sterile Suspension (15 mg)|
12048726|NCT00211419|Drug|Anecortave Acetate 15 mg|
12048727|NCT00211419|Drug|Triamcinolone Acetate 4 mg|
12048728|NCT00211419|Procedure|Photodynamic Therapy with Verteporfin|
12048729|NCT00211419|Procedure|Thermal Laser|
12048730|NCT00211406|Drug|Anecortave Acetate Sterile Suspension (15 mg)|
12048731|NCT00211393|Drug|ketoconazole|600mg. /day for 6 weeks
12048732|NCT00211380|Drug|aripiprazole|10-15 mg daily; if needed dosage may be increased to 30 mg daily after 2 weeks; maintenance 15 mg/day, periodically reassessed.
12048733|NCT00211367|Drug|Anecortave Acetate|
12048734|NCT00211354|Drug|Anecortave Acetate|ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.
12048735|NCT00211341|Dietary Supplement|Vitamin A|Weekly single oral dose 7000 micrograms
12048736|NCT00211328|Drug|anecortave acetate|
12048737|NCT00211315|Drug|anecortave acetate|
12048738|NCT00211302|Drug|aripiprazole|10-15 mg/day; if needed, dosage may be increased to 30 mg/day after week 2; maintenance 15 mg/day; periodically reassessed
12048739|NCT00211289|Behavioral|Education by community pharmacist|
12048740|NCT00211276|Drug|ONTAK (denileukin diftitox)|
12048741|NCT00211263|Behavioral|Enhanced Clinical Intervention|
12048742|NCT00211263|Drug|mood stabilizer|
12048743|NCT00211250|Drug|Valproic Acid and Depakote ER|
12048744|NCT00211237|Device|Balloon Kyphoplasty|Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
12048745|NCT00211237|Other|Non Surgical Management|Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.
12048746|NCT00211224|Drug|Riluzole|
12048747|NCT00211211|Device|Balloon Kyphoplasty|
12048748|NCT00211198|Drug|ONTAK (denileukin difitox, DAB389IL-2)|
12048749|NCT00211185|Drug|Denileukin diftitox|Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles.
12048750|NCT00211185|Drug|Cyclophosphamide|Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
12048751|NCT00211185|Drug|Doxorubicin|Doxorubicin will be administered IV at a dosage of 50 mg/m^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
12048752|NCT00211185|Drug|Vincristine|Vincristine will be administered IV at a dosage of 1.4 mg/m^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
12048753|NCT00211185|Drug|Prednisone|Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
12048754|NCT00211185|Other|Pegfilgrastim|Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm^2) for 2 days post-nadir.
12048755|NCT00211172|Behavioral|Beta-blocker adherence after an AMI|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries.
12048756|NCT00211159|Drug|EPAX 1050TG|
12048757|NCT00211146|Drug|epoetin alfa|
12048758|NCT00211133|Drug|epoetin alfa|
12048759|NCT00211120|Drug|Epoetin Alfa|
12048760|NCT00211107|Drug|Dapoxetine|
12048761|NCT00211094|Drug|Dapoxetine|
12048762|NCT00211081|Drug|Spironolactone (drug)|1 mg/kg/day; afer 2 weeks doubled to 2/mg/kg/day. Patient's with endothelium-dependent brachial artery vasodilation and single-ventricle should show improvement within 4-8 weeks. Patients and their labs who are receiving Spironolactone will be followed.
12048763|NCT00211068|Drug|No intervention|This study is an observational study. No medication will be provided or administered to the participants. Participants will receive standard-of-care treatment from their individual physicians.
12048764|NCT00211042|Other|No intervention|This is an observational study. No medication will be given to the participants. Participants will receive standard-of-care treatment from their individual physicians.
12048765|NCT00211016|Drug|doripenem|
12048766|NCT00211003|Drug|doripenem|
12048767|NCT00210990|Drug|doripenem|
12048830|NCT00210353|Drug|rituximab|rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
12048768|NCT00210977|Drug|No intervention|This is an observational study. All participants will be maintained on their regular dose regimen of standard-of-care treatment, under the guidance of the treating physician/investigator.
12048769|NCT00210964|Drug|ceftobiprole plus placebo|ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
12048770|NCT00210964|Drug|linezolid plus ceftazidime|linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days
12048771|NCT00210951|Other|No Intervention|Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and/or antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators.
12048772|NCT00210938|Drug|Doripenem|
12048773|NCT00210925|Drug|topiramate|
12048774|NCT00210912|Drug|topiramate|
12048775|NCT00210899|Drug|ceftobiprole medocaril|
12048776|NCT00210899|Drug|Vancomycin plus Ceftazidime|
12048777|NCT00210886|Drug|levofloxacin|
12048778|NCT00210873|Drug|topiramate|
12048779|NCT00210860|Drug|topiramate|
12048780|NCT00210847|Drug|tramadol, acetaminophen|
12048781|NCT00210834|Drug|epoetin alfa|
12048782|NCT00210821|Drug|topiramate|
12048783|NCT00210808|Drug|topiramate|
12048784|NCT00210795|Drug|epoetin alfa|
12048785|NCT00210782|Drug|topiramate, phenytoin|
12048786|NCT00210769|Drug|paliperidone ER Oros|
12048787|NCT00210756|Drug|epoetin alfa|
12048788|NCT00210743|Drug|epoetin alfa|
12048789|NCT00210730|Drug|epoetin alfa|
12048790|NCT00210717|Drug|paliperidone palmitate|
12048791|NCT00210704|Drug|Dapoxetine|
12048792|NCT00210691|Drug|Risperidone|
12048793|NCT00210678|Behavioral|No intervention|No treatment is given to the patients as this is an observational study.
12048794|NCT00210665|Drug|Trabectedin|Type= exact number, unit= mg/m2, number= 1.5, form= intravenous infusion, route= intravenous use. 1.5mg/m2 as 24hr infusion on day 1 of each 21 day cycle
12048795|NCT00210652|Drug|RWJ 333369:|Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor
12048796|NCT00210639|Drug|No intervention|This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
12048797|NCT00210626|Drug|PROCRIT|40,000 IU/mL/week for max of 12 weeks
12048798|NCT00210626|Drug|Placebo|40,000 IU/mL/week for max of 12 weeks
12048799|NCT00210613|Drug|Dapoxetine|
12048800|NCT00210600|Drug|PROCRIT (Epoetin alfa)|
12048801|NCT00210587|Drug|epoetin alfa|
12048802|NCT00210574|Drug|topiramate|
12048803|NCT00210561|Drug|tramadol hydrochloride , acetaminophen|
12048804|NCT00210548|Drug|paliperidone palmitate|
12048805|NCT00210535|Drug|Topiramate; Placebo|
12048806|NCT00210522|Drug|RWJ 333369|Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor.
12048807|NCT00210509|Drug|almotriptan malate|
12048808|NCT00210496|Drug|topiramate; almotriptan malate|
12048809|NCT00210483|Drug|almotriptan malate|
12048810|NCT00210470|Biological|IRX-2|IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.
12048811|NCT00210470|Drug|Cyclophosphamide|Single i.v. injection of low-dose (300 mg/m2) on Day 1
12048812|NCT00210470|Drug|Indomethacin|21 days of oral indomethacin, 25 mg. 3 times daily
12048813|NCT00210470|Drug|Zinc|21 days of zinc gluconate (65 mg) as part of an oral multivitamin
12048814|NCT00210470|Drug|Omeprazole|21 days of 20 mg. orally
12048815|NCT00210457|Drug|Lanreotide (Autogel formulation)|
12048816|NCT00210444|Biological|Botulinum toxin type A|
12048817|NCT00210418|Dietary Supplement|Fortified food rations|The Fortified food rations were included in both arms, but targeted to all children 6-24 months of age in the 'preventive' arm and to malnourished children (WAZ <-2 Z-scores) in the 'recuperative arm. Food rations included Corn-Soy Blend, lentils, oil and wheat.
12048818|NCT00210418|Behavioral|Education and communication to improve feeding practices|The education and communication to improve infant and young child feeding was an integral part of the intervention. In the preventive arm, this intervention was targeted to pregnant and lactating mothers and mothers of children 0-24 months of age. The education was done using mother's groups In the recuperative arm, the BCC intervention was only targeted to pregnant and lactating women and mothers of malnourished children under the age of five.
12048819|NCT00210405|Dietary Supplement|"Sprinkles containing mulitple micronutrients"|
12048820|NCT00210405|Behavioral|Education/communication on use of micronutrient sprinkles|
12048821|NCT00210405|Dietary Supplement|Fortified food aid (corn-soy blend)|This intervention was part of the overall food assisted maternal and child health and nutrition program, and included fortified food aid commodities. Corn soy blend was targeted to the child, while the family also received wheat, lentils and oil.
12048822|NCT00210392|Drug|Bortezomib (drug)|Bortezomib 1,3 mg/m2 iv d1,4,8,11 every 21 days. Total 6 cycles
12048823|NCT00210379|Drug|rituximab|
12048824|NCT00210379|Drug|CHOP|
12048825|NCT00210379|Drug|intrathecal methotrexate|
12048826|NCT00210379|Procedure|radiotherapy|
12048827|NCT00210366|Drug|Idarubicin|
12048828|NCT00210353|Drug|chlorambucil (drug)|chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
12048829|NCT00210353|Drug|rituximab+chlorambucil|rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
12048831|NCT00210340|Drug|intrathecal rituximab|
12048833|NCT00210314|Drug|high dose methotrexate|
12048834|NCT00210314|Drug|high dose cytarabine|
12048835|NCT00210314|Radiation|radiotherapy|
12048836|NCT00210301|Drug|Provigil (modafinil)|
12048837|NCT00210288|Biological|SC599|
12048838|NCT00210275|Behavioral|Printed Educational Message|Three forms of printed educational materials (short or long educational messages and patient reminder notes)
12048839|NCT00210262|Behavioral|Feedback and Education|
12048840|NCT00210236|Procedure|Conventional surgery|
12048841|NCT00210223|Procedure|Radiofrequency|
12048842|NCT00210210|Drug|Ketamine|
12048843|NCT00210197|Procedure|Blood collection (pre and postoperative): plasma coagulation parameters|
12048844|NCT00210184|Drug|Irinotecan associated to fluorouracil and leucovorin|
12048845|NCT00210171|Procedure|Toxicity : Time to progression, 1 and 2 years survival|
12048846|NCT00210158|Procedure|Nitrous oxyde|
12048847|NCT00210145|Behavioral|Aesthetic care|
12048848|NCT00210132|Drug|Ropivacaine|
12048849|NCT00210119|Drug|Imatinib mesylate and zoledronic acid|
12048850|NCT00210106|Device|Ablathermy|
12048851|NCT00210093|Drug|denufosol tetrasodium (INS37217)|
12048852|NCT00210080|Drug|Uridine 5'-Triphosphate (UTP) Solution for Inhalation|
12048853|NCT00210067|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
12048854|NCT00210054|Drug|denufosol tetrasodium (INS37217)|
12048855|NCT00210041|Drug|Gemcitabine|Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j
12048856|NCT00210041|Drug|Cisplatin|Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15
12048857|NCT00210028|Drug|Tamoxifen|
12048858|NCT00210028|Drug|Zarnestra|
12048859|NCT00210015|Drug|INS37217 Nasal Spray|
12048860|NCT00210002|Drug|Darbepoetin alfa (Aranesp®)|
12048861|NCT00210002|Drug|Ferric saccharose(Venofer®)|
12048862|NCT00209989|Drug|Zarnestra|ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.
12048863|NCT00209989|Procedure|standard Radiation therapy|Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume
12048864|NCT00209963|Drug|Gaboxadol|
12048865|NCT00209950|Drug|Gaboxadol|
12048866|NCT00209937|Drug|Gaboxadol|
12048867|NCT00209924|Drug|Gaboxadol|
12048868|NCT00209911|Procedure|cardioversion|
12048869|NCT00209898|Procedure|Fast initiation procedure|
12048870|NCT00209885|Drug|Gabapentin|
12048871|NCT00209885|Drug|S-ketamine|
12048872|NCT00209885|Drug|Lidocaine|
12048873|NCT00209885|Drug|Droperidol|
12048874|NCT00209872|Drug|Gabapentin|
12048875|NCT00209872|Drug|Lidocaine|
12048876|NCT00209872|Drug|S-ketamine|
12048877|NCT00209872|Procedure|Epidural analgesia|
12048878|NCT00209859|Drug|Methotrexate|
12048879|NCT00209859|Drug|Intraarticular betamethasone|
12048880|NCT00209859|Drug|Cyclosporine/placebo-cyclosporine|
12048881|NCT00209846|Drug|Gaboxadol|
12048882|NCT00209833|Drug|Cytarabine|
12048883|NCT00209833|Drug|Idarubicin|
12048884|NCT00209833|Drug|Etoposide|
12048885|NCT00209833|Drug|Fludarabine|
12048886|NCT00209833|Drug|G-CSF|
12048887|NCT00209833|Drug|Daunorubicine|
12048888|NCT00209820|Behavioral|Supervised Nordic Walking|
12048889|NCT00209820|Behavioral|Unsupervised Nordic Walking|
12048890|NCT00209820|Behavioral|Advice to stay active|
12048891|NCT00209807|Drug|escitalopram|escitalopram 10 mg/d for 6 weeks
12048892|NCT00209807|Drug|Reboxetine|Reboxetine 8 mg/d for 6 weeks
12048893|NCT00209807|Other|No intervention|This group of healthy volonteers will receive no drug and will be a healthy comparator.
12048894|NCT00209794|Drug|Sulfadoxine-Pyrimethamine (Fansidar)|
12048895|NCT00209781|Drug|Sulfadoxine-Pyrimethamine (Fansidar)|
12048896|NCT00209781|Device|ITNs|
12048897|NCT00209768|Device|Filter: NOE96E, ELD96E, NLF1E, TNA1E|
12048898|NCT00209755|Procedure|therapeutic drug monitoring of ribavirin and dose adaptation|
12048899|NCT00209742|Drug|UFT|P.O. everyday
12048900|NCT00209742|Drug|USEL/Leucovorin|P.O. everyday
12048901|NCT00209742|Drug|Krestin|P.O. everyday
12048902|NCT00209729|Drug|Taxotere|X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
12048903|NCT00209729|Drug|TS-1|Day 1-14, P.O. everyday
12048904|NCT00209716|Drug|Taxotere|30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.
12048905|NCT00209716|Drug|5-Fluorouracil|800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle.
12048906|NCT00209716|Drug|Briplatin|15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle.
12048907|NCT00209703|Drug|Oxaliplatin|
12048908|NCT00209703|Drug|l-Leucovorin|
12048909|NCT00209703|Drug|5-Fluorouracil|
12048910|NCT00209690|Drug|Taxotere|X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
12048911|NCT00209690|Drug|5-FU|800 mg/m2, CIV (conti.in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
12048912|NCT00209690|Drug|Briplatin|15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
12048913|NCT00209677|Drug|Gemcitabine|
12048914|NCT00209677|Drug|S-1|
12048915|NCT00209664|Drug|irinotecan|
12048916|NCT00209664|Drug|S-1|
12048917|NCT00209651|Drug|Campto, Topotesin|q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
12048918|NCT00209651|Drug|TS-1|80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.
12048919|NCT00209638|Drug|irinotecan|
12048920|NCT00209638|Drug|S-1|
12048921|NCT00209625|Drug|irinotecan|
12048922|NCT00209625|Drug|leucovorin|
12048923|NCT00209625|Drug|fluorouracil|
12048924|NCT00209612|Drug|Taxol|Day1,15 X mg/m2, IV (in the vein)
12048925|NCT00209612|Drug|Campt, Topotesin|Day1,15 Y mg/m2, IV (in the vein)
12048926|NCT00209599|Drug|fospropofol disodium|
12048927|NCT00209586|Drug|fospropofol disodium|
12048928|NCT00209573|Drug|fospropofol disodium|
12048929|NCT00209560|Drug|fospropofol disodium|
12048930|NCT00209547|Drug|fospropofol disodium|
12048931|NCT00209534|Drug|fospropofol disodium|
12048932|NCT00209521|Drug|fospropofol|Using a Target Controlled Infusion (TCI) system, the target plasma concentrations of propofol to be administered from AQUAVAN were 0.7 μg/mL (sedation) and 2.5 μg/mL (maintain anesthesia).
12048933|NCT00209521|Drug|propofol|Using a Target Controlled Infusion (TCI) system, the target plasma concentrations of propofol to be administered from Disoprivan were 1.0 μg/mL (sedation) and 3.0 μg/mL (maintain anesthesia).
12048934|NCT00209508|Drug|GPI 1485|
12048935|NCT00209495|Drug|Pregabalin; Dexamethasone|Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
12048936|NCT00209482|Drug|glucophage XR|
12048937|NCT00209469|Drug|alendronate sodium|
12048938|NCT00209456|Drug|DatSCAN|
12048939|NCT00209443|Drug|Gadodiamide Injection|
12048940|NCT00209430|Drug|Iodixanol 320 mgI/mL|
12048941|NCT00209417|Drug|Iodixanol 320-Arm 1|
12048942|NCT00209417|Drug|Iopamidol 300-Arm 2|
12048943|NCT00209404|Drug|Iodixanol 320 mg I/Ml|
12048944|NCT00209391|Drug|Gadodiamide Injection|
12048945|NCT00209378|Other|regional anticoagulation with citrate|Regional anticoagulation with trisodium citrate is compared with standard systemic heparinization.
12048946|NCT00209378|Other|HfCitPre|regional anticoagulation with citrate containing replacement solution
12048947|NCT00209365|Procedure|exposure to grass pollen/starch granules|
12048948|NCT00209352|Drug|Acyclovir|
12048949|NCT00209339|Device|Percutaneous mitral valve repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
12048950|NCT00209326|Drug|FE200440|
12048951|NCT00209313|Drug|Acyclovir|Acyclovir 800 mg twice daily or placebo
12048952|NCT00209300|Drug|Pentasa|
12048953|NCT00209287|Behavioral|Observe patients with inactive ulcerative colitis|Observe patients with inactive ulcerative colitis
12048954|NCT00209274|Device|Percutaneous mitral valve repair using MitraClip implant|MitraClip Implant
12048955|NCT00209274|Procedure|Mitral valve repair or replacement surgery|Repair or replacement of mitral valve
12048956|NCT00209261|Drug|MINIRIN Oral Lyophilisate|
12048957|NCT00209261|Drug|Minirin tablet|
12048958|NCT00209235|Behavioral|Neurocognitive and psychosocial testing|Neurocognitive and psychosocial testing
12048959|NCT00209222|Drug|Rituximab|antibody
12048960|NCT00209222|Drug|Cyclophosphamide|chemotherapy
12048961|NCT00209222|Drug|Doxorubicin|chemotherapy
12048962|NCT00209222|Drug|Vincristine|chemotherapy
12048963|NCT00209222|Drug|Prednisone|corticosteroide
12048964|NCT00209222|Drug|Cisplatinum|chemotherapy
12048965|NCT00209222|Drug|Ara-C|chemotherapy
12048966|NCT00209222|Drug|Dexamethasone|corticosteroide
12048967|NCT00209222|Drug|BCNU|chemotherapy
12048968|NCT00209222|Drug|Melphalan|chemotherapy
12048969|NCT00209222|Drug|Etoposide|chemotherapy
12048970|NCT00209222|Drug|G-CSF|growth factor
12048971|NCT00209222|Procedure|chemotherapy: R-CHOP|immuno-chemotherapy
12048972|NCT00209222|Procedure|chemotherapy: R-DHAP|immuno-chemotherapy
12048973|NCT00209222|Procedure|chemotherapy: Dexa-BEAM|chemotherapy
12048974|NCT00209222|Procedure|stem cell harvest|procedure
12048975|NCT00209222|Procedure|total body irradiation|radiation
12048976|NCT00209222|Procedure|high-dose chemotherapy: Cyclophosphamide|chemotherapy
12048977|NCT00209222|Procedure|high-dose chemotherapy: Ara-C /Melphalan|chemotherapy
12048978|NCT00209209|Drug|Rituximab|antibody
12048979|NCT00209209|Drug|Cyclophosphamide|chemotherapy
12048980|NCT00209209|Drug|Doxorubicin|chemotherapy
12048981|NCT00209209|Drug|Vincristine|chemotherapy
12048982|NCT00209209|Drug|Prednisone|coricosteroide
12048983|NCT00209209|Drug|Fludarabine|chemotherapy
12048984|NCT00209209|Drug|Interferon-alpha|cytokine
12048985|NCT00209209|Drug|pegylated formula Interferon-alpha 2b|cytokine
12048986|NCT00209209|Procedure|chemotherapy: R-CHOP|immuno-chemotherapy
12048987|NCT00209209|Procedure|chemotherapy: R-FC|immuno-chemotherapy
12048988|NCT00209209|Procedure|Interferon maintenance|cytokine
12048989|NCT00209209|Procedure|Rituximab maintenance|antibody
12048990|NCT00209170|Behavioral|Beating the Blues|Beating the Blues is a computerized cognitive behavioral therapy.
12048991|NCT00209170|Drug|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.
12048992|NCT00209170|Drug|Placebo|A sugar pill taken as one to two tablets daily for 6 months.
12048993|NCT00209144|Drug|Intensive insulin therapy|
12048994|NCT00209131|Drug|Flomax|0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.
12048995|NCT00209131|Drug|Sugar pill|Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.
12048996|NCT00209118|Drug|paroxetine|
12048997|NCT00209105|Drug|DEX-CRF stimulation test|1 ug/kg body weight of CRF for determining hpa response post dexamethasone ingestion
12048998|NCT00209105|Behavioral|Psychosocial stress induction|Laboratory stress induction, no drug administration
12048999|NCT00209105|Procedure|Brain imaging of sad mood , self-reference, reward|Brain imaging
12049000|NCT00209105|Behavioral|Acoustic startle|No drugs involved
12049001|NCT00209092|Drug|Docetaxel|"Sequential Therapy: Docetaxel will be given at 100 mg/m^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles.
~Concurrent Therapy: Docetaxel will be given at 50 mg/m^2 IV Day 1."
12049002|NCT00209092|Drug|Capecitabine|Sequential Therapy: administration of capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
12049003|NCT00209079|Drug|Gleevec, Taxotere|Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.
12049004|NCT00209053|Procedure|Coronary Artery Bypass|
12049005|NCT00209040|Behavioral|Acoustic Startle Testing|See protocol description for methodological details
12049006|NCT00209027|Other|fMRI|fMRI scanning during behavioral reward task
12049007|NCT00209027|Drug|Aripiprazole|30 mg by mouth once daily
12049008|NCT00209014|Drug|Thalidomide|
12049009|NCT00209001|Procedure|Acupuncture|Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
12049010|NCT00209001|Procedure|Sham acupuncture therapy|Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.
12049011|NCT00208988|Procedure|Educational handout about prostate cancer screening|
12049012|NCT00208988|Procedure|Simple cue for patient to talk to doctor|
12049013|NCT00208975|Drug|Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF|"Initial patients (n=9) received fludarabine (25 mg/m^2 intravenously) and mitoxantrone (10 mg/m^2 intravenously)with sequential administration of GM-CSF(Granulocyte-macrophage colony stimulating factor) (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m^2) on day 8.
~After a change in the protocol, all additional patients (n=6) received fludarabine (25 mg/m^2 intravenously) and cyclophosphamide (250 mg/m^2 intravenously)with sequential administration of GM-CSF (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m^2) on day 8. All patients received additional doses of GM-CSF (days +8 through +14) were given for patients to reduce variability in neutropenic management."
12049014|NCT00208962|Procedure|chemotherapy and blood stem cell transplantation|A combination of conventional dose chemotherapy, granulocyte-colony stimulating factor (G-CSF) mobilized HLA-identical related allogeneic PBSC transplant, and post transplant infusions of donor leukocytes.
12049015|NCT00208949|Drug|G-CSF|G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
12049016|NCT00208949|Drug|GM-CSF|GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
12049017|NCT00208936|Drug|Taxol, Cisplatin, 5-Fluorouracil, G-CSF|
12049018|NCT00208923|Drug|Busulfan, Cyclophosphamide and Fludarabine|"Bulsufan 1mg/kg/dose P.O. every 6 hours for 4 days. If intravenous, busulfan dose will be 0.8 mg/kg every 6 hours for 16 doses.
~Fludarabine 40 mg/m2 a day for 5 days via IV over 2 hours, dose based on weight.
~Cyclophosphamide given via IV over 1 hour at dose of 60 mg/kg/day for 2 consecutive days."
12049019|NCT00208910|Behavioral|Odorant Cue|
12049020|NCT00208897|Drug|Fluoxetine|
12049021|NCT00208871|Procedure|Stereoscopic Digital Mammography|screening digital 3D mammogram
12049022|NCT00208858|Drug|Topiramate|
12049023|NCT00208832|Procedure|Graphic medication schedule (Pill card)|
12049024|NCT00208832|Procedure|Refill reminder postcard|
12049025|NCT00208819|Drug|risperidone|
12049026|NCT00208819|Drug|quetiapine|
12049027|NCT00208819|Drug|olanzapine|
12049028|NCT00208819|Drug|divalproex|
12049029|NCT00208806|Other|congestive heart failure patients|observational echo data on congestive heart failure patients
12049030|NCT00208793|Dietary Supplement|Calcium and vitamin D3 combined|Calcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with food over 6 months
12049031|NCT00208793|Drug|Placebo|Placebo
12049032|NCT00208793|Dietary Supplement|Calcium|Calcium 2,000 mg/day as calcium carbonate in two divided doses with meals over 6 months
12049033|NCT00208793|Dietary Supplement|Vitamin D3|Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months
12049034|NCT00208780|Drug|Tetrahydrobiopterin|
12049035|NCT00208780|Drug|Tetrahydrobiopterin|
12049036|NCT00208767|Drug|Valsartan|Valsartan was titrated to a target dose of 320 mg orally daily
12049037|NCT00208767|Drug|Placebo|A matched placebo pill will be given orally daily.
12049038|NCT00208741|Drug|Gabitril|
12049039|NCT00208728|Device|PC/SMART cardiopulmonary bypass circuit|
12049040|NCT00208728|Device|PMEA modified cardiopulmonary bypass circuit|
12049041|NCT00208728|Device|Standard of care uncoated cardiopulmonary bypass circuit|
12049042|NCT00208715|Drug|Provigil|
12049043|NCT00208702|Drug|Triiodothyronine|
12049044|NCT00208702|Other|Placebo|
12049045|NCT00208702|Drug|Sertraline|
12049046|NCT00208637|Behavioral|moderate carbohydrate, high protein diet (MCHP)|
12049047|NCT00208637|Behavioral|high carbohydrate-high fibre (HCHF) diet|
12049048|NCT00208611|Dietary Supplement|Vitamin B12 Supplementation|1000 micrograms daily
12049049|NCT00208585|Drug|sertraline|
12049050|NCT00208572|Drug|Citalopram|
12049051|NCT00208559|Drug|Ziprasidone|Ziprasidone 40mg to 60mg per day, individually titrated
12049052|NCT00208546|Drug|21Capecitabine + bevacizumab + oxaliplatin|3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1.
12049053|NCT00208546|Drug|1Capecitabine + oxaliplatin + bevacizumab + cetuximab|3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1, Ce 250 mg/m2 i.v. day 1, 8, 15 (day 1 cycle 1: 400 mg/m2).
12049054|NCT00208533|Drug|Aripiprazole|Aripiprazole 5 mg to 30mg, individually titrated
12049055|NCT00208520|Drug|Carbamazepine|
12049056|NCT00208520|Drug|Lamotrigine|
12049057|NCT00208520|Drug|Levetiracetam|
12049058|NCT00208507|Device|28 mm ceramic head on ceramic acetabular liner.|Total hip replacement with 28 mm ceramic head on ceramic liner articulation
12049059|NCT00208507|Device|28 mm ceramic head on polyethylene liner|Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation.
12049060|NCT00208494|Device|Total Hip Replacement|Total hip replacement
12049061|NCT00208494|Device|Total hip replacement|Total hip replacement
12049062|NCT00208468|Device|European Hip|A cementless femoral component for use in total hip replacement
12049063|NCT00208468|Device|Zweymüller|A cementless femoral component for use in total hip replacement
12049064|NCT00208468|Device|CLS Spotorno|A cementless femoral component for use in total hip replacement
12049065|NCT00208455|Device|DePuy Proxima™ Hip|A short, anatomic, cementless femoral component for use in total hip arthroplasty
12049066|NCT00208442|Device|Marathon™|Moderately cross-linked polyethylene liner in a modular acetabular component
12049067|NCT00208442|Device|Enduron|Standard polyethylene liner in a modular acetabular component
12049068|NCT00208429|Device|Pinnacle Acetabular System|
12049069|NCT00208416|Procedure|DePuy MI System|A minimally invasive surgical technique used in total hip replacement.
12049070|NCT00208416|Procedure|Conventional surgical technique|A conventional surgical technique used in total hip replacement
12049071|NCT00208403|Device|Acryloc™ GHV|A high viscosity bone cement for use in total hip replacement
12049072|NCT00208403|Device|Palacos R|A high viscosity bone cement for use in total hip replacement
12049073|NCT00208390|Device|Summit Tapered Hip System|A cementless, tapered femoral component for use in total hip replacement
12049074|NCT00208377|Device|DePuy ASR Hip System|A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty
12049075|NCT00208364|Device|Pinnacle Acetabular Cup System|A cementless acetabular cup with metal liner for use in total hip replacement
12049076|NCT00208351|Device|Ultima LX Collared Stem - Non-Polished/Blasted Finished|A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.
12049077|NCT00208351|Device|Ultima LX Collared Stem - Polished Finished|A collared polished finished cementless femoral component for use in total hip replacement.
12049078|NCT00208351|Device|Ultima LX Collarless Stem - Non-Polished/Blasted Finished|A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
12049079|NCT00208351|Device|Ultima LX Collarless Stem - Polished finished|A collarless polished finished cementless femoral component for use in total hip replacement.
12049080|NCT00208338|Device|RESTORE SIS Patch|Surgical repair of torn rotator cuff with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement
12049081|NCT00208338|Procedure|Rotator cuff repair|Standard surgical repair of torn rotator cuff
12049082|NCT00208325|Device|P.F.C Sigma Fixed Bearing total knee system|Orthopaedic implant for total knee replacement
12049083|NCT00208325|Device|P.F.C Sigma RP Mobile Bearing knee system|Orthopaedic implant for total knee replacement
12049084|NCT00208312|Drug|Regadenoson|0.4 mg, bolus intravenous injection
12049085|NCT00208312|Drug|Adenosine|0.14 mg/kg/min for 6 minutes, intravenous infusion
12049086|NCT00208299|Drug|Regadenoson|0.4 mg, bolus intravenous injection
12049087|NCT00208299|Drug|Adenosine|0.14 mg/kg/min for 6 minutes, intravenous infusion
12049088|NCT00208286|Device|PFC Sigma Fixed Bearing|PFC Sigma Fixed Bearing system for use in total knee arthroplasty
12049089|NCT00208286|Device|PFC Sigma Mobile Bearing|PFC Sigma Mobile Bearing system for use in total knee arthroplasty
12049090|NCT00208273|Drug|Letrozole - Concomitant|
12049091|NCT00208273|Drug|Letrozole - Sequential|
12049092|NCT00208260|Drug|FOLFIRI|FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
12049093|NCT00208260|Drug|FOLFOX-4|FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
12049094|NCT00208260|Drug|FOLFIRI-HD|High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
12049095|NCT00208260|Drug|FOLFOX-7|FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
12049096|NCT00208260|Drug|FOLFIRINOX|FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks
12049097|NCT00208247|Behavioral|Cognitive behavioral psychotherapy|
12049098|NCT00208234|Drug|Omalizumab|0.016 mg/kg IgE
12049099|NCT00208234|Drug|Placebo for Omalizumab|Placebo
12049100|NCT00208234|Drug|omalizumab|Monoclonal antibody against IgE. 0.016 mg/kg IgE
12049101|NCT00208221|Drug|ramipril|
12049102|NCT00208221|Drug|ramipril-telmisartan|
12049103|NCT00208208|Drug|Ziprasidone|
12049104|NCT00208195|Drug|Divalproex ER|
12049105|NCT00208182|Drug|Risperidone|
12049106|NCT00208169|Drug|Aripiprazole|
12049107|NCT00208156|Drug|Mifepristone|
12049108|NCT00208143|Drug|Quetiapine|
12049109|NCT00208143|Drug|Risperidone|
12049110|NCT00208130|Drug|Topiramate|
12049111|NCT00208117|Drug|Sertraline (Zoloft)|Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If adverse events occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained.
12049112|NCT00208117|Drug|Simvastatin (Zocor)|The placebo drug will be administered for 8 weeks. To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills.
12049113|NCT00208104|Behavioral|Motivational Interviewing|Trained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial.
12049114|NCT00208091|Drug|Botulinum toxin, type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
12049115|NCT00208078|Device|pressure support ventilator|Non invasive ventilation 4h/d 5 days a week
12049116|NCT00208065|Drug|almotriptan or pseudoephedrine|
12049117|NCT00208039|Drug|Infasurf|Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria
12049118|NCT00208026|Drug|Pimecrolimus 1% Cream|Open label single arm
12049119|NCT00208000|Drug|Marine active|
12049120|NCT00207974|Drug|Marine active|
12049121|NCT00207948|Drug|Dose adjustment of Kaletra|Adjust the dose by up to +50% of reccomended dosa off the drug to meet target therapeutic concentrations
12049122|NCT00207935|Behavioral|Swallow instruction|
12049123|NCT00207844|Drug|Selenium as sodium selenite|
12049124|NCT00207831|Drug|Tegafur and Uracil|
12049125|NCT00207818|Device|self assembled skin substitute (SASS)|Wound care with self assembled skin substitute (SASS)
12049126|NCT00207805|Procedure|autologous PBSC transplant|optimal timining of a second autologous transplant
12049127|NCT00207792|Drug|filgrastim|
12049128|NCT00207779|Device|heparin impregnated central venous catheters|
12049129|NCT00207766|Drug|infliximab or placebo|
12049130|NCT00207753|Drug|albendazole vs. combined albendazole/ivermectin treatment|
12049131|NCT00207740|Drug|CNTO148|Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms
12049132|NCT00207740|Drug|Placebo|Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.
12049133|NCT00207727|Drug|CNTO 1275|
12049134|NCT00207714|Drug|Golimumab|Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
12049135|NCT00207714|Drug|MTX|Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
12049136|NCT00207714|Drug|Placebo|Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
12049137|NCT00207714|Drug|Infliximab|Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous
12049138|NCT00207701|Drug|infliximab|
12049139|NCT00207688|Drug|Infliximab 5 mg/kg|Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
12049140|NCT00207688|Drug|Infliximab 10 mg/kg|Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
12049141|NCT00207688|Drug|Placebo|Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.
12049142|NCT00207675|Drug|infliximab|
12049143|NCT00207662|Drug|infliximab or placebo|
12049144|NCT00207649|Behavioral|Shared decision-making for PSA screening tool|Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening. Physicians will be randomized by practice site to receive standard informational brochures (control group) or a novel web-based interactive curriculum that provides education about prostate cancer screening, including potential benefits and harms, fundamentals of effective patient counsel, and shared decision-making. In addition, patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA.
12049145|NCT00207636|Behavioral|Computer-based prostate cancer screening decision aid|
12049146|NCT00207623|Behavioral|Arthritis Basics for Change Education program|
12049147|NCT00207610|Behavioral|Daily iron supplements of 65 mg a day for 3 months|
12049148|NCT00207610|Behavioral|Universal anemia screening and treatment|
12049149|NCT00207610|Behavioral|Selective anemia screening and treatment|
12049150|NCT00207584|Drug|Doxycycline treatment|
12049151|NCT00207571|Behavioral|Computer|
12049152|NCT00207558|Drug|folic acid|
12049153|NCT00207532|Drug|folic acid|
12049154|NCT00207519|Behavioral|weekly behavioral modification group|
12049155|NCT00207519|Behavioral|liquid meal replacements|
12049156|NCT00207506|Behavioral|HoMBReS: A lay health advisor approach to STD prevention|
12049157|NCT00207493|Behavioral|Kit enhancement to referral|
12049158|NCT00207493|Procedure|patient referral versus contract referral|
12049159|NCT00207480|Behavioral|Brief, motivational interviewing intervention|
12049160|NCT00207467|Behavioral|Patient-delivered partner treatment|
12049161|NCT00207467|Behavioral|Booklet-enhanced partner referral|
12049162|NCT00207454|Behavioral|Social Cognitive Counseling|
12049163|NCT00207441|Behavioral|Arthritis Self management program|
12049164|NCT00207441|Behavioral|Chronic Disease Self Management Program|
12049165|NCT00207428|Drug|Carbamazepine|
12049166|NCT00207415|Behavioral|ASHC and CDSMP|
12049167|NCT00207402|Drug|rosiglitazone|Infergen 15mcg/ d Avandia qd Ribavirin bid
12049168|NCT00207376|Device|Solysafe Septal Occluder|
12049169|NCT00207363|Drug|Ribavirin, Peg interferon alfa 2b|Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks
12049170|NCT00207363|Drug|induction therapy|Peg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks
12049171|NCT00207350|Device|Interstitial Laser Therapy|Device
12049172|NCT00207337|Device|Exhale Drug-Eluting Stent|
12049173|NCT00207324|Device|Silver Leaf Dressing|
12049174|NCT00207311|Drug|Xenical, Pegasys, Copegus|Xenical 120mg three times daily for 36 weeks or xenical placebo (Arm 1). Pegasys 180 mcg weekly for 48 weeks. Ribavirin daily for 48 weeks.
12049175|NCT00207311|Behavioral|Xenicare Program|Xenicare program for 36 weeks.
12049176|NCT00207298|Procedure|Positron Emission Tomography|Each patient will receive an 18F-FDG PET/CT scan
12049177|NCT00207285|Behavioral|Sleep Hygiene Education|Baseline general meetings with officers in intervention districts, in which we will provide an introductory program on optimal caffeine use (caffeine re-education) and sleep hygiene, as these are cost-effective measures that may effectively address difficulties adjusting to night work, and low-grade sleep disorders such as mild shift work sleep disorder across the cohort as a whole.
12049211|NCT00207051|Drug|Brivanib + Cetuximab|Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
12049212|NCT00207025|Drug|BMS-275183|
12049213|NCT00207012|Drug|BMS-599626|
12049214|NCT00206999|Drug|imipramine|Either 50 mg of imipramine or placebo will be administered to healthy male volunteers
12049362|NCT00205660|Other|Stayers|Participants remain on their current antipsychotic.
12049178|NCT00207285|Procedure|Screening and Treatment of Sleep Disorders|All individuals who screen positive in the questionnaires on the baseline survey will be referred to one of the physicians at Sleep HealthCenters® or other sleep clinics in Massachusetts. Individuals will be paid $40 for attending an initial consultation visit with a sleep clinician and $400 if they are then asked to undergo an overnight sleep study and they complete the sleep study. Individuals will also be asked to wear an ApneaLink device for 2 nights at home and for 1 night during the overnight visit at Sleep HealthCenters®. Subjects may be asked to wear the ApneaLink device for more than 2 nights if there are not 4 hours of usable data each night. If the data is inadequate, subjects will be asked to wear the device until 4 hours of usable data on 2 nights is achieved. The ApneaLink device is an FDA approved sleep-screening tool that is used to identify individuals that are at risk for Obstructive Sleep Apnea Syndrome.
12049179|NCT00207272|Behavioral|1170-1870 kcal/day liquid diet|
12049180|NCT00207272|Procedure|Gastric bypass surgery|
12049181|NCT00207272|Procedure|Biopsy.visceral adipose tissue|
12049182|NCT00207272|Procedure|Biopsy.omental adipose tissue|
12049183|NCT00207272|Procedure|Biopsy. subcutaneous abdominal adipose tissue|
12049184|NCT00207272|Procedure|Blood sample|
12049185|NCT00207259|Behavioral|Reiki & Relaxation Response Therapy with Cognitive Restructuring|"Relaxation Therapy: Practice of focus on breathing or repeated word while ignoring random thoughts without bias. Designed to lower heart rate, blood pressure and stress.
~Reiki: Practice of laying on hands by a Reiki therapist in order to channel patient's energy, considered calming and pleasant."
12049186|NCT00207233|Behavioral|MCT oil hypocaloric liquid diet|"The MCT diet will consist of 5 liquid meals using a commercial product (HMR 800 Health Management Resources, Inc.; 160 kcal/shake) plus 34 grams MCT oil (Life Enhancement Products, Inc. Petaluna, CA; 8.3 kcal/gm) added per day to the HMR shakes.
~The intervention will last 3 months. After the first 6 weeks you will be assessed for 5% weight loss. If reach this weight change you will continue on the same intervention for another 6 weeks. Those who do not lose 5% of their baseline weight will be withdrawn from the study."
12049187|NCT00207233|Behavioral|LCT hypocaloric liquid diet|"The LCT diet will consist of 5 liquid meals using a commercial product (HMR 800 Health Management Resources, Inc.; 160 kcal/shake) plus 31.5 grams LCT oil (corn oil; 9 kcal/gm) per day. Both diets will be isocaloric (1083 kcal/day) consisting of 38% CHO, 28% pro, 34% fat.
~The intervention will last 3 months. After the first 6 weeks you will be assessed for 5% weight loss. If reach this weight change you will continue on the same intervention for another 6 weeks. Those who do not lose 5% of their baseline weight will be withdrawn from the study."
12049188|NCT00207233|Procedure|Subcutaneous abdominal adipose tissue biopsy|"Subcutaneous adipose tissue biopsies from human subjects will provide tissue samples for ex vivo analysis of adipocytokine production and cell size. Subcutaneous adipose tissue will be sampled by needle biopsy at the suprailiac crest skinfold using standard sterile technique. After a 10 cm area is isolated, cleaned and anesthetized with 1% lidocaine, a small cutaneous incision (1 cm) will be performed. A 50 cc syringe with a 19-gauge needle will be used to aspirate approximately 150 mg of adipose tissue which will require 2 to 6 passes of the needle. Sutures will be used to close the skin incision and a dry sterile dressing applied.
~This will be performed at baseline, 6 weeks, and 12 weeks."
12049189|NCT00207220|Procedure|arterial tonometry|used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.
12049190|NCT00207220|Procedure|echocardiography|ultrasound test using sound waves to create a moving picture of the heart
12049191|NCT00207207|Procedure|Alternate site blood glucose testing|
12049192|NCT00207194|Behavioral|Automated Telephone Program|The intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values. Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.). These participants also received the same health behavior education those in the control condition received.
12049193|NCT00207194|Behavioral|Health Behavior Education|Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).
12049194|NCT00207168|Behavioral|Compliance|
12049195|NCT00207155|Drug|Cetuximab|IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.
12049196|NCT00207142|Drug|Atazanavir + 2 NRTIs|Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
12049197|NCT00207142|Drug|Atazanavir + Ritonavir + 2 NRTIs|Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
12049198|NCT00207129|Drug|Ixabepilone|Solution, I.V. infusion, 40 mg/m2, Cycles 1-18: once per cycle (Day 1) cycles 2-18 (6-54 weeks) depending on response.
12049199|NCT00207129|Drug|Capecitabine|Tablets, Oral, 1000 mg/m2, Cycle 1: Once (Day 1) Cycle 2: Twice daily (Days 1-5) Cycles 3-18: None, 2 cycles (6 weeks).
12049200|NCT00207116|Drug|Cetuximab|IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.
12049201|NCT00207103|Drug|Brivanib|Tablets, Oral, 180 mg, once daily, until disease progression
12049202|NCT00207103|Drug|Brivanib|Tablets, Oral, 320 mg, once daily, until disease progression
12049203|NCT00207103|Drug|Brivanib|Tablets, Oral, 600 mg, once daily, until disease progression
12049204|NCT00207103|Drug|Brivanib|Tablets, Oral, 800 mg, once daily, until disease progression
12049205|NCT00207103|Drug|Brivanib|Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
12049206|NCT00207103|Drug|Brivanab|Tablets, Oral, 1000 mg, once daily, until disease progression
12049207|NCT00207090|Drug|ixabepilone|ixabepilone solution, intravenous, 40 mg/m2, once every 3 weeks until disease progression
12049208|NCT00207090|Drug|Rifampin|rifampin tablets, oral, 600 mg once daily, only on Days 15 to 21 of Cycle 1 and Days 1 to 7 of Cycle 2
12049209|NCT00207077|Drug|Cetuximab + Erlotinib|IV solution + tablet, IV+ oral, ERB 100 mg/m2, 200 mg/m2, 250 mg/m2 IV + Erl 150 mg tablet, ERB weekly/ Erl once daily, Until disease progression.
12049210|NCT00207064|Drug|quetiapine|flexible doses according to the clinical condition
12049215|NCT00206986|Drug|clonidine|Either placebo or 25 ug, 50 uG 75 ug or 150 ug of clonidine will be added to the current medication of patients with schizophrenia, who are stable on their current medication
12049216|NCT00206986|Drug|clonidine|0.15 mg of clonidine will be administered to 20 healthy male volunteers
12049217|NCT00206973|Procedure|mannitol test|
12049218|NCT00206960|Drug|zuclopenthixol|Patients will be administered zuclopenthixol orally in doses between 4 -24 mg/day, depending on an effective reduction of symptoms
12049219|NCT00206960|Drug|risperidone|Patients will be administered risperidone orally in doses between 1-6 mg/day, depending on an effective reduction of symptoms
12049220|NCT00206947|Drug|donepezil (5-10 mg/day)|Donepezil will be administered in a dose optimized for treatment, to patients who are stabilized on a ziprasidone treatment
12049221|NCT00206947|Drug|Placebo|Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment
12049222|NCT00206934|Drug|Escitalopram|Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers
12049223|NCT00206934|Drug|escitaolpram|Either 15 mg of escitalopram or placebo will be administered to healthy volunteers
12049224|NCT00206921|Device|Pulsed dye laser|
12049225|NCT00206921|Device|Intense pulsed light|
12049226|NCT00206895|Procedure|Photodynamic therapy|
12049227|NCT00206882|Drug|corticosteroids|
12049228|NCT00206869|Behavioral|exercise|
12049229|NCT00206869|Behavioral|heat|
12049230|NCT00206869|Procedure|red light illumination|
12049231|NCT00206856|Device|Triage® B-Type Natriuretic Peptide (BNP) Test|
12049232|NCT00206843|Device|Triage BNP Test|
12049233|NCT00206830|Device|Triage Profiler S.O.B. Panel|
12049234|NCT00206817|Device|Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP)|
12049235|NCT00206791|Device|MBCP-Gel (tm)|
12049236|NCT00206778|Drug|Lamotrigine|
12049237|NCT00206778|Drug|Sodium Valproate|
12049238|NCT00206765|Drug|Risperidone|
12049239|NCT00206765|Drug|Paroxetine|
12049240|NCT00206752|Radiation|Radiation therapy|definitive external beam radiation in the ipsilateral neck.
12049241|NCT00206752|Radiation|definitive external beam radiation in the ipsilateral neck|definitive external beam radiation in the ipsilateral neck
12049242|NCT00206739|Drug|Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)|
12049243|NCT00206726|Drug|Alemtuzumab plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
12049244|NCT00206713|Drug|Sargramostim (Leukine)|6 μg/kg sargramostim administered SC once daily for 8 weeks
12049245|NCT00206713|Drug|Placebo|Placebo administered SC once daily during the randomized retreatment phase.
12049246|NCT00206700|Drug|Sargramostim (Leukine)|Open Label, 8 week cycle
12049247|NCT00206687|Biological|Spheramine (BAY86-5280)|Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
12049248|NCT00206687|Procedure|Placebo|Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
12049249|NCT00206674|Drug|Sargramostim (Leukine)|6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
12049250|NCT00206674|Drug|Placebo|Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
12049251|NCT00206661|Drug|Sargramostim (Leukine)|4 mcg sargramostim with and without corticosteroids
12049252|NCT00206661|Drug|Sargramostim (Leukine)|6 mcg sargramostim with and without corticosteroids
12049253|NCT00206648|Drug|Betaferon/Betaseron|Betaseron 250 µg SC every other day
12049254|NCT00206648|Drug|Betaferon/Betaseron|Avonex 30 µg IM once per week
12049255|NCT00206635|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Betaseron was not administered as part of this study, only the treatment and disease status was assessed. As part of the MRI analysis Gadolinium was administered in patients who underwent this procedure
12049256|NCT00206622|Drug|Climara PRO (Estradiol / Levonorgestrel transdermal)|2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
12049257|NCT00206622|Drug|Menostar (Estradiol transdermal)|1mg 17 Beta-estradiol transdermal patch
12049258|NCT00206622|Drug|Placebo transdermal|Placebo
12049259|NCT00206609|Procedure|Oxygen and air administration|
12049260|NCT00206596|Drug|Sargramostim (Leukine)|Once daily via subcutaneous injection for up 22 weeks
12049261|NCT00206596|Drug|Placebo|Once daily via subcutaneous injection for up 22 weeks
12049262|NCT00206583|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658ID)|GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)
12049263|NCT00206570|Drug|Estradiol|
12049264|NCT00206557|Drug|Raloxifene|
12049265|NCT00206557|Drug|Estradiol/dyhydroprogestrone|
12049266|NCT00206544|Drug|Tamoxifen|40 mg daily of adjunctive tamoxifen in oral capsule
12049267|NCT00206544|Drug|Progesterone|20 mg daily of adjunctive progesterone in oral capsule
12049268|NCT00206544|Other|placebo|adjunctive placebo daily in oral capsule
12049269|NCT00206518|Drug|Taxotere/Docetaxel|Taxotere
12049270|NCT00206518|Drug|Adriamycin/Cytoxan|Adriamycin/Cytoxan
12049271|NCT00206518|Drug|doxorubicin|AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
12049272|NCT00206505|Drug|Taxotere|
12049273|NCT00206492|Drug|Iressa|Iressa
12049274|NCT00206492|Drug|Tamoxifen|Tamoxifen
12049275|NCT00206466|Drug|Taxotere|Docetaxel (Taxotere) 100 mg/m2 is to be administered on day 1. A core biopsy is to be performed one day after chemotherapy (day 2) and on days 8, 15 and 22. On day 22, after repeat core biopsy, a second cycle of docetaxel (Taxotere) chemotherapy (100 mg/m2) will be given. Docetaxel (Taxotere) will be given three-weekly for a total of four cycles. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.
12049358|NCT00205699|Drug|olanzapine|randomized to begin 12 week trial of olanzapine
12049359|NCT00205699|Drug|aripiprazole|randomized to 12 week trial of aripiprazole
12049276|NCT00206466|Drug|Adriamycin/cytoxan|Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.
12049277|NCT00206453|Drug|Taxotere|Chemotherapy IV
12049278|NCT00206440|Drug|esomeprazole|nexium
12049279|NCT00206440|Other|Placebo|Placebo 1 pill daily Cycle 1 Days 1-5 and Cycle 2 Days 1-5
12049280|NCT00206427|Drug|GW572016|Lapatinib, 500 mg
12049281|NCT00206427|Drug|lapatinib|Lapatinib 500 mg PO
12049282|NCT00206414|Drug|Iressa Day 1 given with Arimidex and Faslodex|timing of administration of iressa is the study factor
12049283|NCT00206414|Drug|Iressa Day 21 given with Arimidex and Faslodex|Timing of Iressa is the study factor
12049284|NCT00206401|Drug|Lantus and short acting analogs Vs NPH and short acting analogs|
12049285|NCT00206388|Drug|Zolendric acid|IV, 2mg/m2/dose on day 0
12049286|NCT00206388|Drug|Cyclophosphamide|fixed dose of 25mg/m2/dose days 0-27
12049287|NCT00206375|Drug|Growth hormone|Growth hormone + Synthroid + Lupron
12049288|NCT00206375|Drug|Growth hormone treatment and puberty|Lupron once a month and growth hormone daily
12049289|NCT00206336|Drug|Topiramate (drug)|Topiramate 25 mg to 200 mg
12049290|NCT00206323|Drug|Topiramate (drug)|Topiramate 25 mg titrated to 200 mg
12049291|NCT00206323|Drug|placebo/sugar pill|placebo
12049292|NCT00206310|Drug|CRESTOR|
12049293|NCT00206297|Drug|Pramlintide|
12049294|NCT00206284|Drug|AZD0865|
12049295|NCT00206271|Behavioral|neck collar; advice to act-as-usual; active mobilisation|
12049296|NCT00206258|Drug|Pramlintide and glucagon|
12049297|NCT00206245|Drug|AZD0865|
12049298|NCT00206232|Drug|Spironolactone|Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.
12049299|NCT00206219|Drug|Gefitinib|
12049300|NCT00206219|Drug|methotrexate|
12049301|NCT00206206|Procedure|Hyperglycemia Protocol Procedure|
12049302|NCT00206193|Drug|mifepristone|
12049303|NCT00206193|Drug|misoprostol|
12049304|NCT00206193|Drug|sulprostone|
12049305|NCT00206180|Drug|esomeprazole magnesium (oral medication)|
12049306|NCT00206167|Drug|Budesonide/formoterol pMDI|
12049307|NCT00206167|Drug|Formoterol Turbuhaler|
12049308|NCT00206154|Drug|Budesonide/formoterol pMDI|
12049309|NCT00206154|Drug|Budesonide pMDI|
12049310|NCT00206154|Drug|Formoterol Turbuhaler|
12049311|NCT00206141|Drug|Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)|
12049312|NCT00206128|Drug|Seroquel SR|
12049313|NCT00206115|Drug|Seroquel Sustained Release (SR)|
12049314|NCT00206115|Drug|Seroquel Immediate Release (IR)|
12049315|NCT00206115|Drug|Placebo|
12049316|NCT00206102|Drug|quetiapine fumarate|flexible dose oral
12049317|NCT00206102|Drug|risperidone|flexible dose oral
12049318|NCT00206089|Drug|EXANTA|
12049319|NCT00206076|Drug|mycophenolate mofetil|mycophenolate mofetil and half their baseline dose of calcineurin inhibitor
12049320|NCT00206076|Drug|mycophenolate mofetil|mycophenolate mofetil monotherapy
12049321|NCT00206063|Drug|EXANTA|
12049322|NCT00206050|Drug|Esomeprazole|
12049323|NCT00206050|Drug|pantoprazole|
12049324|NCT00206037|Device|COLLOSS E|
12049325|NCT00206037|Device|TomoFix Plate|
12049326|NCT00206024|Drug|Esomeprazole magnesium (Nexium)|
12049327|NCT00206011|Procedure|Endoscopic surgery|Open surgical intervention compared to endoscopic intervention
12049328|NCT00205998|Device|Locking Compression Plate 2,4mm|
12049329|NCT00205998|Device|Locking Compression Plate 3,5mm|
12049330|NCT00205985|Device|Scaphoid screw|Conservative treatment versus application of scaphoid screw
12049331|NCT00205972|Device|Humerus Nail or LC Plate|
12049332|NCT00205959|Device|Locking proximal humerus plate|
12049333|NCT00205959|Device|Proximal Humerus Internal Locking System|
12049334|NCT00205959|Device|Proximal Humerus Nail|
12049335|NCT00205946|Drug|Bupropion|150 mg of bupropion administered 5 hours before fMRI scanning
12049336|NCT00205946|Drug|Placebo|Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)
12049337|NCT00205920|Biological|BLVR Hydrogel|10 mL BLVR Hydrogel
12049338|NCT00205907|Biological|BLVR Hydrogel|10 mL BLVR Hydrogel
12049339|NCT00205894|Device|bion microstimulator|
12049340|NCT00205881|Device|HiRes 90K Bionic Ear System|Cochlear implant system
12049341|NCT00205868|Device|Precision Spinal Cord Stimulation System|Stimulation on throughout study
12049342|NCT00205855|Device|Precision SCS|Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
12049343|NCT00205842|Drug|alvimopan|
12049344|NCT00205829|Device|battery-powered bion(R) microstimulator system|Stimulation on from initial activation and on.
12049345|NCT00205816|Drug|Tigecycline|
12049346|NCT00205803|Biological|13-Valent Pneumococcal Conjugate Vaccine (13vPnC)|
12049347|NCT00205803|Biological|7-Valent Pneumococcal Conjugate Vaccine (7vPnC)|
12049348|NCT00205790|Device|Vascular graft|
12049349|NCT00205777|Drug|Bazedoxifene Acetate|BZA 20mg, daily, oral
12049350|NCT00205777|Other|Placebo|Placebo, daily, oral
12049351|NCT00205764|Drug|Melphalan|
12049352|NCT00205751|Drug|Thalidomide/Dexamethasone vs Melphalan/Prednisone|
12049353|NCT00205738|Drug|Risperidone, Olanzapine|
12049354|NCT00205725|Drug|Ziprasidone, Olanzapine|
12049355|NCT00205712|Drug|Ketamine|Ketamine without dexmedetomidine
12049356|NCT00205712|Drug|Dexmedetomidine|Ketamine plus dexmedetomidine
12049357|NCT00205699|Drug|risperidone|randomized to begin 12 week trial of risperidone
12049363|NCT00205660|Other|Switchers|Subjects are randomized to switch to aripiprazole from their current antipsychotic.
12049364|NCT00205647|Drug|Oral N-acetycystein (NAC)|
12049365|NCT00205634|Drug|Biaxin ( clarithromycin)|
12049366|NCT00205621|Device|Positron Emission Tomography|
12049367|NCT00205608|Device|Positron Emission Tomography|camera is new
12049368|NCT00205595|Device|Positron Emission Tomography|
12049369|NCT00205582|Device|Positron Emission Tomography|
12049370|NCT00205569|Behavioral|First Steps Educational Curriculum|10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration
12049371|NCT00205556|Procedure|on-line hemodiafiltration|addition of convective transport to regular dialysis treatment by using on-line hemodiafiltration
12049372|NCT00205556|Procedure|low flux hemodialysis|standard treatment
12049373|NCT00205543|Procedure|uvulopalatopharyngoplasty with or without sutures|standard UPPP
12049374|NCT00205530|Behavioral|Brain Injury Family Intervention (BIFI)|The Brain Injury Family Intervention (BIFI) was developed over the last decade based upon considerable clinical experience and research review. The BIFI is a structured approach to helping families address their most common and salient issues, concerns, and challenges. The BIFI is implemented in five 90-minute sessions.
12049375|NCT00205517|Procedure|Daily interruption of sedation versus sedation algorithm|
12049376|NCT00205504|Drug|Ortho Tri Cyclen|Ortho Tri Cyclen, one tablet daily, for 6 cycles
12049377|NCT00205491|Drug|Venlafaxine|
12049378|NCT00205478|Drug|VX-702|
12049379|NCT00205465|Drug|VX-765|
12049380|NCT00205426|Drug|Natrecor|Natrecor will be initiated as a bolus dose of 2 mcg/kg followed by a continuous infusion via infusion pump after induction of anesthesia but prior to incision. Natrecor infusion will be started at the recommended rate of 0.01mcg/kg/min. This dose may be adjusted by the investigator(s) only based on hemodynamic monitoring and pulmonary parameters. Study drug will be infused for a minimum of 24 hours and a maximum of 96 hours.
12049381|NCT00205400|Procedure|medical care delivery model|
12049382|NCT00205387|Procedure|cardiac elastography and echocardiography|standard echocardiogram
12049383|NCT00205374|Drug|Cidofovir|With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults. The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected. Because the volumes of cidofovir injected into the airway will be reasonably small (typically less than 2 mL), the total systemic dose of cidofovir administered per visit will be far below the FDA-approved systemic limit of 5 mg/kg for HIV-related CMV retinitis.
12049384|NCT00205374|Drug|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
12049385|NCT00205335|Device|Ascencia Breeze Glucose meter|All study participants received glucose meter and test strips.
12049386|NCT00205335|Device|Breeze Glucose Monitor (Bayer)|Each participant received a Breeze monitor and glucose test strips.
12049387|NCT00205322|Drug|chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)|
12049388|NCT00205296|Behavioral|exercise|this will test the effect of exercise on insulin sensitivity, fitness and body composition
12049389|NCT00205283|Drug|Nelfinavir|
12049390|NCT00205270|Drug|Influenza vaccine|influenza vaccine 0.5 ml intramuscularly each season
12049391|NCT00205244|Behavioral|Healing images, relaxation and distraction materials|
12049392|NCT00205231|Drug|etanercept|
12049393|NCT00205205|Behavioral|peer mentoring|
12049394|NCT00205192|Procedure|Cardiac resynchronization pacing|various pacemaker modes used over 1 hour
12049395|NCT00205179|Drug|Novasoy|100mg/day soy isoflavones
12049396|NCT00205179|Drug|Placebo|100mg/day matching placebo
12049397|NCT00205166|Procedure|Cardiac SPECT imaging Rest and Stress|adenosine perfusion scintigraphy
12049398|NCT00205166|Drug|Caffeine|Caffeine 400 mg po
12049399|NCT00205166|Drug|Caffeine|Caffeine 200 mg po
12049400|NCT00205153|Behavioral|Pharmacy TEAM monitoring and counseling|Pharmacy team monitors and counsels patient using automatic BP monitors and special TEAM tools for assessing and improving patient adherence, barriers to adherence, lifestyle, drug therapy, BP control, and collaboration with physicians.
12049401|NCT00205127|Procedure|Cardiac PET imaging- rest and pharmacological stress|
12049402|NCT00205114|Behavioral|Individualized multifactorial intervention for community-living high-risk older adults|
12049403|NCT00205114|Behavioral|Health professional education program about fall prevention|
12049404|NCT00205062|Procedure|PET-CT|
12049405|NCT00205049|Drug|pentoxifylline|daily dosing
12049406|NCT00205023|Procedure|Sonohysterography|SHG during surgery for endometrial cancer.
12049407|NCT00205010|Procedure|Lymphoscintigraphy|
12049408|NCT00204997|Procedure|Laparoscopic ovarian transposition|Laparoscopic ovarian transposition
12049409|NCT00204984|Drug|oral hydralazine and intravenous nesiritide|vasodilators
12049410|NCT00204971|Dietary Supplement|Enteral glutamine powder|nutritional supplement
12049411|NCT00204971|Other|placebo|placebo control
12049412|NCT00204958|Drug|nutritional supplement|
12049413|NCT00204958|Drug|glutamine popsicle|
12049414|NCT00204945|Drug|nesiritide|a bolus, then infusion of nesiritide for 10-15 minutes
12049415|NCT00204932|Drug|conjugated linoleic acid|4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months
12049416|NCT00204919|Drug|Vitamin D|once-monthly vitamin D oral capsules (50,000 units)
12049417|NCT00204919|Drug|placebo|once-monthly placebo capsules
12049418|NCT00204906|Dietary Supplement|vitamin D supplementation|
12049419|NCT00204893|Drug|calcium formate|Calcium formate - Each uncoated white tablet will contain 650 mg of calcium formate, (equivalent to 200 mg elemental calcium). Nephro-Tech, LLC, will formulate and provide the calcium formate tablets for the study.
12049420|NCT00204867|Other|CTC surveillance|In vivo CTC surveillance of 6-9 mm polyp
12049421|NCT00204854|Behavioral|telephone counseling|
12049422|NCT00204802|Behavioral|Patient-Centered Advance Care Planning|
12049423|NCT00204789|Drug|Difluoromethylornithine|
12049424|NCT00204776|Drug|Capecitabine and Oxaliplatin|
12049425|NCT00204763|Device|Air filled balloon catheter|The new air filled balloon catheter will be tested against the solid state catheter
12049426|NCT00204763|Device|Solid state catheter|The standardly used solid state catheter will be tested against the new air filled balloon catheter
12049427|NCT00204750|Procedure|Bougie Dilation|Bougie dilation will be performed as standard
12049428|NCT00204750|Procedure|Needle-knife incision|Needle-knife incision will be performed
12049429|NCT00204737|Drug|prednisone|20mg x 2 weeks
12049430|NCT00204737|Drug|placebo|placebo
12049431|NCT00204711|Other|SNAP II EEG System|A portable EEG monitor (SNAP II EEG System, Everest -St. Louis) is unique in that it monitors both low frequency EEG signals (1-40 Hz), which are typically used, and high frequency EEG signals (80-420 Hz), which are not usually used, and calculates a derived EEG parameter (the SNAP Index). The SNAP Index ranges from 100 (completely awake) to 0 (no brain activity) and has been shown in a few studies to correlate with increasing sedation and loss of consciousness in human volunteers and patients receiving general anesthesia during surgery.
12049432|NCT00204698|Drug|Aciphex|20 mg of aciphex taken twice daily
12049433|NCT00204685|Drug|dornase alfa|
12049434|NCT00204672|Drug|Achipex|
12049435|NCT00204659|Drug|Rituximab + CHOP chemotherapy|standard Rituximab + CHOP chemo-immunotherapy
12049436|NCT00204646|Drug|Adriamycin|
12049437|NCT00204646|Drug|Ifosfamide|
12049438|NCT00204646|Drug|Etoposide|
12049439|NCT00204646|Drug|Carboplatin|
12049440|NCT00204633|Drug|Darbepoetin alfa|
12049441|NCT00204620|Drug|Bendamustin|
12049442|NCT00204607|Biological|mRNA|
12049443|NCT00204607|Drug|GM-CSF s.c.|
12049444|NCT00204594|Drug|rM28|
12049445|NCT00204594|Drug|autologous PBMCs|
12049446|NCT00204581|Drug|Interleukin-2 (Proleukin)|6-12 MIE/d 3times a week
12049447|NCT00204568|Drug|Adriamycin|60 mg/m2, d1, W d22
12049448|NCT00204568|Drug|Trofosfamide|300 mg absolute d1-7, followed by 150 mg absolute continuously
12049449|NCT00204555|Drug|Imiquimod|
12049450|NCT00204542|Drug|Diclofenac|Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
12049451|NCT00204542|Drug|Diclofenac|Solaraze® (Diclofenac sodium) 2x/day topical for 6 months
12049452|NCT00204529|Drug|pegylated interferon-alpha-2a|
12049453|NCT00204529|Drug|interferon-alpha-2a|
12049454|NCT00204516|Biological|mRNA coding for melanoma associated antigens|mRNA vaccine s.c. applied weekly
12049455|NCT00204516|Drug|GM-CSF|Given s.c. as adjuvant drug one day after vaccine
12049456|NCT00204503|Drug|Depakote ER|
12049457|NCT00204490|Dietary Supplement|isoflavones|soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.
12049458|NCT00204490|Dietary Supplement|carbohydrate|carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.
12049459|NCT00204477|Dietary Supplement|soy milk|Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.
12049460|NCT00204477|Dietary Supplement|cow's milk|Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
12049461|NCT00204464|Procedure|Exercise|
12049462|NCT00204451|Drug|0.75 levonorgestrel|
12049463|NCT00204451|Drug|50 mg ethinyl estradiol/0.5 mg levonorgestrel|
12049464|NCT00204438|Drug|0.15mg desogestrel /0.03mg ethinyl estradiol|
12049465|NCT00204425|Dietary Supplement|exercise/soy isoflavone|Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
12049466|NCT00204412|Dietary Supplement|Flax lignan|543 mg SDG per day
12049467|NCT00204412|Behavioral|Exercise (walking)|walking 45 minutes per day 5 days per week
12049468|NCT00204399|Behavioral|Telephone counseling support|
12049469|NCT00204386|Drug|Topiramate|
12049470|NCT00204373|Drug|Lansoprazole (Prevacid)|Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.
12049471|NCT00204347|Drug|risperidone|
12049472|NCT00204334|Drug|darbopoeitin|
12049473|NCT00204321|Drug|sirolimus (drug), mmf (drug)|
12049474|NCT00204308|Drug|Combination tenofovir-emtricitabine|Tenofovir disoproxil 300 mg / emtricitabine 200 mg taken as a single dose during labor
12049475|NCT00204295|Drug|O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET|
12049476|NCT00204282|Behavioral|Educational presentation, group discussion, questionnaires|
12049477|NCT00204269|Drug|Testosterone Gel Wolff|
12049478|NCT00204256|Drug|Iron sucrose|
12049479|NCT00204243|Drug|Naltrexone|surgically implanted naltrexone releasing during 5 to 6 months
12049480|NCT00204243|Drug|Methadone|Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
12049481|NCT00204230|Drug|mycophenolate mofetil (drug)|
12049482|NCT00204217|Device|endotracheal intubation|
12049483|NCT00204191|Drug|tacrolimus|
12049484|NCT00204178|Behavioral|Oxidative stress in kidney transplant recipients|
12049485|NCT00204165|Procedure|MRI of the small bowel|
12049486|NCT00204152|Behavioral|(Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation|
12049487|NCT00204139|Procedure|Routine midtrimester pregnany ultrasound scan|
12049488|NCT00204126|Device|Treadmill with partial body weight support|
12049489|NCT00204126|Device|Surface Functional Electrical Stimulation|
12049490|NCT00204113|Device|Multi-purpose rehabilitation frame|
12049491|NCT00204113|Device|Surface Functional Electrical Stimulation|
12049492|NCT00204100|Device|Surface Functional Electrical Stimulation|
12049493|NCT00204087|Behavioral|Cognitive behavioral therapy (CBT)|
12049494|NCT00204087|Behavioral|Supportive Counselling (SC)|
12049495|NCT00204074|Drug|17-beta-estradiol (drug)|
12049496|NCT00204061|Behavioral|Supportive management|The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.
12049497|NCT00204061|Drug|Amisulpride|Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.
12049498|NCT00204048|Behavioral|Observation (behavior)|Inpatients admitted in GenMed at the University of Chicago will be consented to participate in an inpatient interview that consists of questions related to quality of care and satisfaction. The patient will also be interviewed over the phone 30 days after discharge and will be asked questions related to current health and their satisfaction during their stay at University of Chicago.
12049499|NCT00204035|Behavioral|Evaluation (behavior)|TEACH is a precollege enrichment program for highschool students to encourage and promote these students towards careers in clinical research. To accomplish this, instruments designed to evaluate the knowledge, attitudes, and behaviors are administered during their participation in the TEACH program.
12049500|NCT00204022|Drug|Mycophenolate mofetil|Mycophenolate mofetil
12049501|NCT00204022|Drug|Azathioprine|Azathioprine
12049502|NCT00204009|Behavioral|Disease Surveillance, Family Studies, Questionnaire Followup|
12049503|NCT00203996|Device|continuous positive airway pressure (CPAP)|CPAP is the most effective treatment available for sleep disordered breathing. CPAP provides a constant, controllable pressure to keep your upper airway open during sleep so that you can breathe normally. The pressure acts much in the same way as a splint and holds the airway open.
12049504|NCT00203996|Drug|depot leuprolide plus estrogen/progestin replacement|Depot leuprolide is a long-acting, modified version of the natural brain hormone, gonadotropin releasing hormone (GnRH). This study drug will temporarily reduce the pituitary hormones that stimulate the ovaries to make both female (estrogen) and male (testosterone) hormones. The effect of this study drug will last approximately 12 weeks. During this time, your female hormone levels will be brought to normal by the use of a patch that contains estrogen and progesterone. This patch is placed on the skin and is changed twice a week. The subject will continue to wear this patch for 4 weeks after the end of the study, until the effects of the Lupron injection wear off.
12049505|NCT00203996|Drug|pioglitazone|Pioglitazone (Actos). Pioglitazone is an oral medication approved in the Unites States for the treatment of patients with type 2 diabetes (however it is not approved for studies in this protocol). This is one of a class of drugs known as thiazolidinediones. This class of drugs has been associated with potential beneficial changes in the metabolism (use of glucose by the body) as well as lipids (fats) in the blood.
12049506|NCT00203996|Procedure|REM frag|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
12049507|NCT00203996|Procedure|SWS supp|SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
12049508|NCT00203970|Behavioral|Observation|Using a data abstraction form, we wish to gather the following information: 1) Patient demographics 2) identity of the attending, residents, and interns caring for the patient 3)whether the patient had any absolute or relative contraindications for receiving LMWH 4) how the patient was treated for his/her condition
12049509|NCT00203957|Drug|Istradefylline|Patients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d
12049510|NCT00203957|Drug|Istradefylline|Patients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d
12049511|NCT00203944|Behavioral|Behavioral, Development|
12049512|NCT00203931|Drug|Cetuximab|
12049513|NCT00203931|Drug|Pemetrexed|
12049514|NCT00203918|Behavioral|Survey, interview|A survey is administered to patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand patients' individual evaluations of treatment-related health states. Medical records will also be reviewed 00 days after the survey was administered to determine whether this data reflects actual treatment decisions.
12049515|NCT00203918|Behavioral|patient utility scores (i.e. patient preference weights)|comparison of patient preferences
12049516|NCT00203905|Drug|5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab|Hydroxyurea at 500 mg PO q 12 hours x 6 days; Bevacizumab at 10 mg/kg as a 90-minute infusion; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)
12049517|NCT00203905|Drug|5-Fluorouracil, Hydroxyurea-[FHX]|Hydroxyurea at 500 mg PO q 12 hours x 6 days; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)
12049518|NCT00203892|Biological|modified CEA peptide (10mcg)|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
12049519|NCT00203892|Biological|modified CEA peptide (100mcg)|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
12049520|NCT00203892|Biological|modified CEA peptide (1000mcg)|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
12049521|NCT00203879|Drug|MAGE-3/Melan-A/gp100/NA PBMC, rhIL-12 (drug)|draft
12049522|NCT00203879|Drug|MAGE-3/Melan-A/gp100/NA17 Peptide-pulsed autologous PBMC, rhIL-12 with IL-2|MAGE-3/Melan-A/gp100/NA17 Peptide-pulsed autologous PBMC, rhIL-12 with IL-2
12049523|NCT00203866|Drug|G250 peptide|
12049524|NCT00203866|Drug|IL-2|
12049525|NCT00203853|Device|pillbox, wristwatch|
12049526|NCT00203814|Drug|Sulfadoxine-pyrimethamine|
12049527|NCT00203814|Drug|Artesunate plus sulfadoxine-pyrimethamine|
12049528|NCT00203801|Drug|Sulfadoxine-pyrimethamine|
12049529|NCT00203801|Drug|Artesunate plus sulfadoxine-pyrimethamine|
12049530|NCT00203801|Drug|Artemether-lumefantrine|
12049531|NCT00203788|Behavioral|Individual Placement and Support|Supported education/employment
12049532|NCT00203788|Behavioral|Workplace Fundamentals Module|Group skills training on job/school topics
12049533|NCT00203788|Behavioral|Brokered Vocational Rehabilitation|Vocational rehabilitation through traditional separate state-funded agency
12049534|NCT00203788|Drug|Oral risperidone|Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist
12049535|NCT00203788|Behavioral|Skills training group|Group social skills training that did not focus primarily on work situations
12049536|NCT00203775|Drug|risperidone|
12049537|NCT00203762|Behavioral|Public sector antiretroviral treatment programmes|
12049538|NCT00203749|Behavioral|Community-Based HIV VCT|"COMMUNITY MOBILIZATION. This component of the intervention uses community outreach to enhance the uptake of VCT, thus increasing the rate of HIV testing and frequency of discussions about HIV and reducing stigma through community education and mobilization.
~EASY ACCESS TO VCT. This component is designed to remove practical barriers and increase safety of VCT. Mobile vans or temporary units set up at local community sites will provide free, anonymous VCT in specific, chosen sites where people gather, such as market areas, shopping centers, and community centers.
~POST-TEST SUPPORT SERVICES. This component is designed to build psychosocial support to improve the quality of life for individuals diagnosed with HIV. The expected outcomes include a reduction in social harm, an increase in social support through disclosure to those most likely to provide support, and a reduction in internalized stigma. Social support should also decrease the behavioral risk of further transmission."
12049539|NCT00203749|Behavioral|Standard clinic-based VCT|Control communities will receive Standard Clinic-Based VCT (SVCT) instead of the community-based VCT (CBVCT) intervention. Each of these communities will have access to SVCT that reflects local access to health care. The training for VCT counselors will be the same in the CBVCT and SVCT communities; however, no active recruitment for participation in the SVCT services will be made beyond the standard procedures of each clinic for informing patients of services (e.g., telling individual patients that VCT is available, posting of a flyer in the clinic announcing VCT availability, etc). As such, no active outreach or community mobilization will be conducted by the study staff in the SVCT settings (although it is possible that such activities will occur due to local initiative).
12049540|NCT00203736|Drug|Sulfadoxine-pyrimethamine|
12049541|NCT00203736|Drug|Artesunate plus sulfadoxine-pyrimethamine|
12049542|NCT00203723|Drug|Risperidone|
12049543|NCT00203710|Device|Concentric Retriever Device|
12049544|NCT00203697|Drug|minocycline|
12049545|NCT00203684|Drug|Flunisolide-HFA|
12049546|NCT00203658|Drug|Tinzaparin sodium|
12049547|NCT00203645|Behavioral|Self-help treatment|"Workbook Becoming a Winner,"
12049548|NCT00203632|Drug|rosiglitazone/placebo|
12049549|NCT00203619|Device|Wireless capsule endoscopy|wire less capsule endoscopy
12049550|NCT00203619|Other|standard care|standard diagnostic evaluation as decided by treating physician
12049551|NCT00203606|Drug|pegylated interferon alfa-2a ( Roche) and ribavirin|pegylated interferon alfa-2a ( Roche) and ribavirin
12049552|NCT00203593|Behavioral|Exercise|
12049553|NCT00203593|Device|Blood volume|
12049554|NCT00203593|Procedure|VO2max test|
12049555|NCT00203593|Procedure|Lower body negative pressure|
12049556|NCT00203593|Behavioral|Heart Rate|
12049557|NCT00203593|Procedure|Blood Pressure|
12049558|NCT00203593|Behavioral|Total Peripheral Resistance|
12049559|NCT00203580|Drug|Tinzaparin sodium|
12049560|NCT00203567|Drug|carbamazepine ER|Active study drug, no comparator
12049561|NCT00203554|Genetic|Poly methylmetacrylate, PMMA|
12049562|NCT00203541|Device|TELFA™ A.M.D. Island dressing|
12049563|NCT00203528|Drug|divalproex sodium ER|
12049564|NCT00203528|Drug|risperidone|
12049565|NCT00203515|Device|Standard Latex Foley Catheter|
12049566|NCT00203515|Device|Silver Coated Latex Foley Catheter|
12049567|NCT00203502|Drug|Bevacizumab|IV 15mg/kg 21 days
12049568|NCT00203502|Drug|Cyclophosphamide|500mg per meter squared, IV every 21 days
12049569|NCT00203502|Drug|Docetaxel|60 mg per meter squared, IV every 21 days
12049570|NCT00203489|Device|KERLIX A.M.D. Gauze|
12049571|NCT00203476|Drug|Niacin|
12049572|NCT00203476|Drug|Colestipol|
12049573|NCT00203476|Drug|Ezetimibe|
12049574|NCT00203463|Drug|topiramate|
12049575|NCT00203450|Drug|Zonegran|zonisamide
12049576|NCT00203450|Drug|Placebo|Placebo pill
12049577|NCT00203424|Drug|Erlotinib + Bevacizumab|Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses
12049578|NCT00203411|Drug|Capecitabine (Xeloda)|1000mg/m^2 administered orally twice daily for two weeks followed by one week rest period
12049579|NCT00203411|Drug|Bevacizumab|7.5 mg/kg IV will be administered every 3 weeks
12049580|NCT00203385|Drug|Divalproex|Depakote up to 2000mg/d
12049581|NCT00203372|Drug|Bevacizumab 7.5 and TAC|Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).
12049582|NCT00203372|Drug|Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)|placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC
12049583|NCT00203372|Drug|Bevacizumab 15 and TAC|one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.
12049584|NCT00203372|Drug|Placebo 15 and TAC|one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.
12049585|NCT00203359|Drug|etanercept given by perispinal administration|
12049586|NCT00203346|Procedure|Greater Occipital Nerve Block|
12049587|NCT00203333|Device|Medtronic REVEAL|
12049588|NCT00203320|Drug|etanercept given by perispinal administration|
12049589|NCT00203307|Drug|Olanzapine during first intervention period and placebo during second intervention period|Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period)
12049590|NCT00203307|Drug|Placebo during first intervention period, then olanzapine during second intervention period|Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).
12049591|NCT00203294|Drug|lidocaine, bupivicaine and saline|lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
12049592|NCT00203294|Drug|lidocaine plus bupivicaine plus triamcinolone (steroid)|lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
12049593|NCT00203281|Drug|tacrolimus|
12049594|NCT00203281|Drug|mycophenolate mofetil|
12049595|NCT00203281|Drug|daclizumab|
12049596|NCT00203281|Drug|intravenous immune globulin|
12049597|NCT00203281|Procedure|plasmapheresis|
12049598|NCT00203268|Drug|dihydroergotamine mesylate|1.0 mg. intramuscularly
12049599|NCT00203255|Drug|Soy Isoflavones|
12049600|NCT00203242|Drug|Depacon IV and Depakote ER|
12049601|NCT00203229|Drug|lamotrigine|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication.
12049602|NCT00203229|Drug|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
12049603|NCT00203216|Drug|levetiracetam|Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg)
12049604|NCT00203216|Procedure|Transcranial Magnetic Stimulation|
12049605|NCT00203203|Device|Intramyocardial Injection of stem cells via NOGA Mapping|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.
12049606|NCT00203203|Other|Control, then Stem Cell Therapy|Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.
12049607|NCT00203190|Drug|Topiramate|
12049608|NCT00203177|Drug|rasagiline mesylate|0.5 rasagiline mesylate
12049609|NCT00203177|Drug|rasagiline mesylate 1.0 mg|1.0 mg rasagiline mesylate
12049610|NCT00203164|Drug|rasagiline mesylate|rasagiline mesylate 1 mg oral once daily
12049611|NCT00203151|Drug|edratide|0.5 mg, 1.0 mg, 2.5 mg injection once weekly
12049612|NCT00203138|Drug|rasagiline mesylate|
12049613|NCT00203125|Drug|rasagiline mesylate|0.5 or 1 mg oral, once-daily
12049614|NCT00203125|Other|tyramine|50 mg once daily
12049615|NCT00203112|Drug|glatiramer acetate with minocycline|Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
12049616|NCT00203112|Drug|Glatiramer acetate with placebo|Subcutaneous injection glatiramer acetate 20mg, with oral placebo
12049617|NCT00203099|Drug|Glatiramer Acetate, N-Acetylcysteine|Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.
12049618|NCT00203073|Drug|glatiramer acetate 20 mg|glatiramer acetate 20 mg
12049619|NCT00203073|Drug|glatiramer acetate 20 mg, with mitoxantrone|glatiramer acetate 20 mg, with mitoxantrone
12049620|NCT00203060|Drug|Rasagiline Mesylate|tablet, 1 or 2 mg, daily, 58 weeks
12049621|NCT00203060|Drug|placebo|tablet, once daily, 58 weeks
12049622|NCT00203047|Drug|Glatiramer Acetate|20mg glatiramer acetate (GA) administered by daily subcutaneous injections
12049623|NCT00203047|Drug|Placebo|Placebo for prednisone given daily
12049624|NCT00203047|Drug|Prednisone|Prednisone 1250 mg taken daily
12049625|NCT00203034|Drug|rasagiline mesylate|0.5 mg rasagiline mesylate oral once daily
12049626|NCT00203034|Drug|1.0 mg rasagiline mesylate|1.0 mg rasagiline mesylate oral once daily
12049627|NCT00203034|Other|Placebo|oral placebo once daily
12049628|NCT00203021|Drug|Glatiramer acetate|Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.
12049629|NCT00202995|Drug|Glatiramer Acetate|20 mg s.c. daily
12049630|NCT00202995|Drug|Betaseron|250 mg every other day
12049631|NCT00202995|Drug|Rebif|44 ug 3 times a week
12049632|NCT00202982|Drug|glatiramer acetate 20 mg|glatiramer acetate 20 mg
12049633|NCT00202982|Drug|glatiramer acetate 40 mg|glatiramer acetate 40 mg
12049634|NCT00202969|Drug|S-1|S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.
12049635|NCT00202969|Drug|S-1 plus CDDP|S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.
12049636|NCT00202969|Drug|5-FU plus CDDP|5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.
12049637|NCT00202956|Drug|Bugusan|
12049638|NCT00202943|Procedure|TCRFVR and LAUP|
12049639|NCT00202930|Drug|anti-CD20 (Rituximab)|
12049640|NCT00202917|Drug|Fludarabine|
12049641|NCT00202917|Drug|Thiotepa|
12049642|NCT00202917|Drug|Melphalan|
12049643|NCT00202917|Drug|OKT-3|
12049644|NCT00202917|Procedure|CD3/CD19 depletion on CliniMACS|
12049645|NCT00202904|Drug|ezetimibe|ezetimibe 10 mg tablets, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks
12049646|NCT00202904|Drug|placebo|placebo tablets matched to ezetimibe, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks
12049647|NCT00202891|Drug|sisomicin|
12049648|NCT00202878|Drug|ezetimibe/simvastatin|Ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
12049694|NCT00202475|Procedure|whole blood collection|collection of whole blood
12049695|NCT00202462|Drug|Testosterone gel|Testosterone gel 7.5 gm qd
12049696|NCT00202449|Drug|prazosin|taken by mouth, twice daily, titrated up to efficacy or a maximum of 5 mg at 10a and 25 mg at bedtime for duration of study
12049649|NCT00202878|Drug|simvastatin|Simvastatin 40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
12049650|NCT00202878|Drug|Placebo for simvastatin 40 mg|one or two tablets orally daily
12049651|NCT00202878|Drug|Placebo for ezetimibe 10 mg/simvastatin 40 mg combination|one tablet orally daily.
12049652|NCT00202865|Biological|infliximab|Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6 and every 8 weeks thereafter. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).
12049653|NCT00202865|Biological|Placebo|Placebo infusions at Weeks 0, 2, and 6. Subjects will be evaluated at Week 12 after which they will receive infliximab 3 mg/kg at Weeks 16, 18, and 22 then every 8 weeks. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).
12049654|NCT00202852|Other|Placebo|Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX
12049655|NCT00202852|Drug|MTX|Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week
12049656|NCT00202852|Biological|Infliximab|Infliximab 3 mg/kg given as an infusion at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX
12049657|NCT00202852|Drug|MTX|3 mg/kg infliximab infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week
12049658|NCT00202839|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program
12049659|NCT00202839|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program
12049660|NCT00202839|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program
12049661|NCT00202839|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program
12049662|NCT00202826|Procedure|Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage|
12049663|NCT00202813|Device|Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter|
12049664|NCT00202800|Drug|Gemcitabine, Etoposide|Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer
12049665|NCT00202787|Drug|FOLFOX-4+cetuximab|"Cetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes);
~FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2"
12049666|NCT00202787|Drug|FOLFOX-4|FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2
12049667|NCT00202774|Drug|(capecitabine, oxaliplatin, 5-fluorouracil)|
12049668|NCT00202761|Behavioral|PIH|Intensified training
12049669|NCT00202748|Behavioral|Increase in activity to control weight|
12049670|NCT00202748|Behavioral|Increase in activity to control weight.|
12049671|NCT00202735|Procedure|Arm1:Immobilization in external rotation|Immobilization in external rotation (ER) All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling Er,15˚ version).To control the position,a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed in 15 degrees of external rotation.
12049672|NCT00202735|Procedure|immobilization in internal rotation|All the patients in the internal rotation(IR) group are immobilized with their arm/shoulder in internal rotation by using a normal collar and cuff device.
12049673|NCT00202722|Drug|Remifentanil|Intravenous patient controlled analgesia (ivpca) during labour
12049674|NCT00202709|Behavioral|Thought Field Therapy (TFT)|Treatment with TFT twice in one week
12049675|NCT00202696|Drug|nalmefene|Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period).
12049676|NCT00202696|Other|Placebo|Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).
12049677|NCT00202657|Procedure|echocardiography|
12049678|NCT00202644|Drug|Anagrelide|Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.
12049679|NCT00202644|Drug|Hydroxyurea|Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.
12049680|NCT00202631|Device|Surface Functional Electrical Stimulation|
12049681|NCT00202618|Drug|Valsartan|
12049682|NCT00202618|Drug|Amlodipine|
12049683|NCT00202605|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate|
12049684|NCT00202592|Drug|Perindopril|
12049685|NCT00202579|Drug|Ivabradine|
12049686|NCT00202566|Drug|Ivabradine|
12049687|NCT00202553|Drug|Perindopril|
12049688|NCT00202540|Drug|S18986|
12049689|NCT00202527|Device|Nasal continuos positive airway pressure|
12049690|NCT00202514|Drug|divalproex sodium extended release|
12049691|NCT00202501|Device|Nasal CPAP (Continuous Positive Airway Pressure)|
12049692|NCT00202488|Drug|H. pylori treatment|
12049693|NCT00202475|Procedure|eythrocytapheresis|machinal collection of erythrocytes
12049697|NCT00202449|Drug|paroxetine|20 mg taken at 10a for duration of the study
12049698|NCT00202449|Drug|Placebo|Placebo
12049699|NCT00202436|Procedure|Phlebotomy|Removal of 500 ml whole blood
12049700|NCT00202436|Procedure|Erythrocytapheresis|machinal removal of erythrocytes
12049701|NCT00202423|Drug|Sativex|
12049702|NCT00202410|Biological|Bacille of Calmette-Guerin|A single intracutaneous dose of 0.1 mL freeze-dried BCG (1 mg/mL; Berna Institute, Basel).
12049703|NCT00202410|Other|placebo|subcutaneous administration of physiologic solution
12049704|NCT00202397|Drug|Riluzole|capsule-shaped 50 mg tablets bid for 8 weeks
12049705|NCT00202397|Other|placebo|capsule-shaped tablet bid for 8 weeks
12049706|NCT00202371|Procedure|Red Blood Cell transfusion|
12049707|NCT00202358|Drug|atenolol|
12049708|NCT00202358|Drug|placebo|
12049709|NCT00202345|Drug|Iron sucrose|
12049710|NCT00202332|Procedure|Coronary artery bypass|
12049711|NCT00202319|Procedure|Sedation management protocol|
12049712|NCT00202306|Drug|lithium carbonate|
12049713|NCT00202293|Drug|Olanzapine|
12049714|NCT00202293|Drug|Lithium|
12049715|NCT00202293|Drug|Chlorpromazine|
12049716|NCT00202280|Drug|Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg|
12049717|NCT00202267|Device|Four-layer Bandage (Elastomeric)|Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week.
12049718|NCT00202267|Device|Short-stretch Bandage (Non-elastomeric)|These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record.
12049719|NCT00202254|Behavioral|Physiotherapy|
12049720|NCT00202254|Behavioral|Occupational therapy|
12049721|NCT00202254|Behavioral|Speech pathology|
12049722|NCT00202241|Procedure|testosterone injection|
12049723|NCT00202228|Drug|cofactor supplementation (thiamine, riboflavin, L-carnitine)|Thiamine: 50 mg po od; Riboflavin: 100 mg po od; L-carnitine: 990 mg po bid.
12049724|NCT00202215|Behavioral|Chrysalis Day Program|
12049725|NCT00202202|Procedure|consultation format|
12049726|NCT00202189|Drug|Budesonide|Nebulized Budesonide (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered to subjects once only.
12049727|NCT00202176|Drug|Ipratropium Bromide|Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.
12049728|NCT00202163|Drug|DHEA|
12049729|NCT00202163|Drug|Testosterone|
12049730|NCT00202150|Behavioral|Application of a management action plan|
12049731|NCT00202137|Behavioral|Home blood pressure monitoring|Monitor blood pressure using home blood pressure monitor
12049732|NCT00202137|Behavioral|Physician monitoring of blood pressure|Blood pressure measured as standard care from physician (no home monitor given for blood pressure monitoring)
12049733|NCT00202124|Drug|Tryptophan|
12049734|NCT00202111|Procedure|Laparoscopic-assisted colectomy|
12049735|NCT00202111|Procedure|Conventional open colectomy|
12049736|NCT00202098|Procedure|Variable ventilation|"Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and traditional CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period the investigators will record the gas exchange parameters and the mechanics of the respiratory system."
12049737|NCT00202059|Drug|Zoledronic acid|
12049738|NCT00202059|Behavioral|Physical activity intervention|
12049739|NCT00202033|Behavioral|frequency of self monitoring blood glucose|Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.
12049740|NCT00202020|Drug|Cilostazol 200mg/day Oral|
12049741|NCT00202020|Drug|Aspirin 100mg/day Oral|
12049742|NCT00202007|Drug|Aripiprazole tablet, 5-30mg/day, oral, 6 weeks|
12049743|NCT00202007|Drug|Risperidone tablet, 1-6mg/day, oral, 6 weeks|
12049744|NCT00201994|Drug|Tolvaptan|
12049745|NCT00201981|Drug|Rebamipide|"OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
~OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks"
12049746|NCT00201968|Device|Compex Motion Stimulator|Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
12049747|NCT00201968|Device|Compex Motion Stimulator|Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
12049748|NCT00201968|Other|Conventional Exercise|An aerobic and resistance training program.
12049749|NCT00201955|Drug|Rebamipide|
12049750|NCT00201942|Procedure|PET scan|
12049751|NCT00201929|Procedure|Standard Decision Board|
12049752|NCT00201929|Procedure|Computer Decision Board|
12049753|NCT00201929|Procedure|Paper Decision Board|
12049754|NCT00201916|Procedure|5250 cGy/20 fractions over 28 days|see above
12049755|NCT00201916|Procedure|6600 cGy/33 fractions over 45 days|see above
12049756|NCT00201890|Procedure|Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)|20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove
12049757|NCT00201877|Drug|Velcade|"Induction: 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13 & 14.
~Maintenance: 1.3 mg/m2 IV day 1 weekly x 2 weeks beginning week 20 and continuing every 6 months until month 23."
12049758|NCT00201877|Drug|Rituximab|"Induction: 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13 and 14 prior to Velcade administration.
~Maintenance: 375 mg/m2 day 1 weekly x 4 weeks."
12049759|NCT00201864|Drug|Exemestane|25 mg orally per day
12049760|NCT00201864|Drug|Fulvestrant|250 mg IM starting on Day 8 and then every 28 days.
12049761|NCT00201851|Drug|Tamoxifen|20 mg po daily x 5 years
12049762|NCT00201851|Procedure|Surgery: Oophorectomy|Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
12049763|NCT00201838|Drug|Gemcitabine|The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
12049764|NCT00201838|Drug|Etanercept|Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study.
12049765|NCT00201825|Drug|Capecitabine|1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
12049766|NCT00201825|Drug|Docetaxel|36 mg/m2 IV weekly for 3 weeks every 4 weeks.
12049767|NCT00201812|Drug|Etanercept|7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
12049768|NCT00201812|Drug|Docetaxel|Administered intervenously (IV) over 30 minutes through an infusion pump once a week (every 7 days). A cycle will comprise six weekly treatments followed by 2 weeks of rest.
12049769|NCT00201812|Drug|Dexamethasone|Administered orally 8 mg 12 hours prior to docetaxel, immediately prior to docetaxel (two hours after etanercept), and 12 hours after docetaxel to complete a total of 3 doses (total dose 24 mg/week) on treatment weeks.
12049770|NCT00201799|Drug|Infliximab|"A total of 6 doses of Infliximab will be administered as follows:
~Dose 1: 10 mg/kg IV one day prior to commencing the myeloablative preparative regimen Dose 2: 10 mg/kg IV on day 0 to be given after peripheral blood stem cell infusion Dose 3: 10 mg/kg IV on day +7 Dose 4: 10 mg/kg IV on day +14 Dose 5: 10 mg/kg IV on day +28 Dose 6: 10 mg/kg IV on day +42"
12049771|NCT00201786|Drug|Pentostatin|Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).
12049772|NCT00201773|Drug|Exemestane|25 mg orally once per day for 16 weeks.
12049773|NCT00201773|Drug|Celecoxib|given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.
12049774|NCT00201773|Other|Correlative studies|
12049775|NCT00201760|Drug|Gemcitabine|1000 mg/m2 IV over 30 minutes on Days 1 and 8.
12049776|NCT00201760|Drug|Trastuzumab|2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
12049777|NCT00201760|Drug|Cisplatin|30 mg/m2 IV on Day 1 and Day 8.
12049778|NCT00201747|Drug|CPT-11|CPT-11 will be administered intravenously on days 2 and 9 (24 hours after MMC, when the MMC is required) Two weeks of rest (beginning days 15 and 22) (drug free) will complete the cycle, with therapy planned to be resumed on day 29.
12049779|NCT00201747|Drug|Mitomycin C|MMC will be administered intravenously on day 1 (Arm A) and days 1 and 8 (Arm B)
12049780|NCT00201734|Drug|Capecitabine|Level 1: 500 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 2: 750 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 3 - 5: 1000mg/m2 orally twice daily Days 8 - 21 of each cycle.
12049781|NCT00201734|Drug|Carboplatin|Levels 1-5: AUC of 6 every 4 weeks.
12049782|NCT00201734|Drug|Paclitaxel|Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week.
12049783|NCT00201721|Drug|Pentostatin|2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.
12049784|NCT00201721|Drug|Rituximab|For the first week only: Day 1 of therapy 100 mg IV over 4 hours. Day 3 of therapy 375 mg/m2 IV at 50 mg/hr and increase by 100 mg/hr at 30-minute intervals to a maximum of 400 mg/hr. Day 5 of therapy 375 mg/m2 IV at 100 mg/hr for the first 15 minutes the remainder goes in at 45 minutes. The remaining weeks 375 mg/m2 will be repeated as a single IV infusion Day 1 of Week 4, 7, 10, 13 and 16 during cycles 2-6.
12049785|NCT00201721|Drug|Cyclophosphamide|600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6
12049786|NCT00201708|Drug|Docetaxel|Arm A:75 mg/m2 every 2 weeks)for 4 cycles. Arm B:75 mg/m2 every 2 weeks for 4 cycles.
12049787|NCT00201708|Drug|Doxorubicin|60 mg/m2 intravenously as push over 2-5 minutes, every 14 days for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide) , Arm B (Docetaxel after doxorubicin/cyclophosphamide)
12049788|NCT00201708|Drug|Cyclophosphamide (AC)|600 mg/m2 over 30 to 60 minutes every 14 days (2 weeks) for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide)
12049789|NCT00201695|Drug|Doxil®|40 mg/m2 IV day 1
12049790|NCT00201695|Drug|Vincristine|1.4 mg/m2 (maximum 2 mg) IV day 1
12049791|NCT00201695|Drug|Dexamethasone|40 mg PO days 1-4
12049792|NCT00201695|Drug|Arsenic Trioxide|0.25 mg/kg IV over 1-4 hours twice per week, week 1-4 of each cycle (i.e., days 1 and 4; 8 and 11; 15 and 18; 22 and 25)
12049793|NCT00201682|Drug|Etanercept|25 mg SQ twice weekly weeks 1-5
12049794|NCT00201682|Drug|Rituximab|(375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5
12049795|NCT00201669|Drug|Clofarabine|Clofarabine 30 mg/m2/day will be administered as a 2-hour intravenous infusion (IVI) on days 1-5.
12049796|NCT00201656|Procedure|Retention of Cerclage|Retain Cerclage until clinical removal is indicated by protocol
12049797|NCT00201656|Procedure|Removal of Cerclage|Immediate removal of Cerclage following randomization
12049798|NCT00201656|Procedure|Removal vs. Retention of Cervical Cerclage|Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress
12049799|NCT00201643|Drug|Betamethasone or Dexamethasone (2nd course of ACS)|Course of Betamethasone or Dexamethasone
12049800|NCT00201643|Drug|Placebo|Course of Placebo (NS)
12049801|NCT00201630|Drug|Uroxatrol (drug)|
12049802|NCT00201617|Device|Bone-anchored hearing aid|
12049803|NCT00201591|Behavioral|Exercise training for 10 weeks|
12049804|NCT00201552|Drug|Statin|
12049805|NCT00201539|Drug|single dose Morphine|
12049806|NCT00201539|Drug|double dose Morphine|
12049807|NCT00201539|Drug|placebo|purchased from the manufacturer of morphine tablets (Nycomed Pharma, Oslo, Norway)
12049808|NCT00201513|Behavioral|Isolated Transversus abdominis (TrA) exercise|Eight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback
12049809|NCT00201513|Behavioral|sling exercise|Eight weeks sling(high load) exercise program; Isolated TrA control through biofeedback
12049810|NCT00201513|Behavioral|group exercise|Eight weeks non-specific group exercise program; Isolated TrA control through biofeedback
12049811|NCT00201461|Device|STARFlex septal closure system|transcatheter placement of STARFlex device to close a patent foramen ovale
12049812|NCT00201461|Drug|Best medical therapy|aspirin (325 mg daily) and/or warfarin (target INR = 2.5)
12049813|NCT00201448|Biological|Hepatitis A Vaccine|Single dose give IM
12049814|NCT00201448|Biological|Towne CMV Vaccine|Single dose given subcutaneously
12049815|NCT00201435|Drug|Paclitaxel weekly in combination with capecitabine|
12049816|NCT00201435|Drug|Docetaxel every 3 week in combination with capecitabine|
12049817|NCT00201422|Other|Omeprazole, Amoxicillin, Clarithromycin|Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus
12049818|NCT00201409|Drug|Placebo|Placebo will be administered by slow intravenous infusion once daily for 14 days.
12049819|NCT00201409|Drug|GM-CSF|Recombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days.
12049820|NCT00201396|Radiation|CCRT|Radiation with weekly Cisplatin
12049821|NCT00201396|Drug|Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin|Induction C/T + CCRT
12049822|NCT00201383|Drug|cisplatin|
12049823|NCT00201357|Drug|Thalidomide (THADO)|patients who receive thalidomide (100 mg BID).
12049824|NCT00201344|Drug|Cisplatin,5-FU,Leucovorin|
12049825|NCT00201331|Drug|leucovorin+5-FU|
12049826|NCT00201318|Drug|Cyclophosphamide Doxorubicin Vincristine Lamivudine|
12049827|NCT00201305|Drug|Gemcitabine+5FU+Leucovorin|
12049828|NCT00201279|Drug|13-cis Retino Acid|
12049829|NCT00201266|Procedure|Screening|Characterization tests including blood group typing, measures of lung function, measures of allergy, and collection of DNA.
12049830|NCT00201253|Other|Bronchoalveolar lavages and venipunctures only|
12049831|NCT00201240|Biological|CD34+ selection with CliniMACS device|CD34+ cell selection will be performed according to procedures given in the CliniMACS Users Operating Manual and institutional Standard Operating Procedures (SOPs) in place and validated at the study sites. CliniMACS (Miltenyi device) to target CD34+ >5 x 10*6/kg and CD3+ < 1 x 10*5/kg
12049832|NCT00201227|Other|practice guideline adherence|Project facilitator assist primary care practice clinicians and staff work in effective quality improvement teams through the use of facilitated collaborative meetings.
12049833|NCT00201214|Drug|Citrulline|Phase I - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with dosage escalation study 50mg/kg, 100mg/kg, 150mg/kg IV at 6, 12, 24, 48 hours post operative. Phase II - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with 9mg/kg/hr continuous IV starting 4 hours post bolus and infusing for 48 hours or discharge from PCCU.
12049834|NCT00201201|Other|Education Intervention|Adults aged 60 and over with hypertension were randomized to usual care and intervention groups. Both groups entered medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education intervention group received a tailored education program.
12049835|NCT00201201|Other|Control|Control group receiving care as usual after interfacing with the surveys on the PEP-NG
12049836|NCT00201188|Behavioral|Status Reports|Interpreted Analysis of Peak-Flow Monitoring Trends
12049837|NCT00201162|Dietary Supplement|Soy|Dietary supplement of isolated soy protein containing isoflavones
12049838|NCT00201162|Dietary Supplement|Placebo|dietary supplement casein placebo
12049839|NCT00201149|Behavioral|Patient-centered Counseling|To improve patients' adherence with prescribed anti-hypertensive medication, improve blood pressure control and doctor-patient communication, we propose a three-armed randomized controlled trial in the internal medicine clinics of a large metropolitan teaching hospital which serves a large percentage of poor African American and white patients. We will implement an intervention strategy by teaching clinicians to counsel patients about hypertension control through the use of patient-centered counseling and by providing office-based support; critical to facilitating clinicians' use of this strategy. Through this intervention we will provide clinicians with communication skills that are proven to help patients change risk-related behaviors, and which will enhance doctor-patient communication.
12049840|NCT00201136|Behavioral|Lifestyle interventions to lower blood pressure for patients|Weight loss, DASH dietary pattern, increased physical activity, reduced salt intake, moderation of alchohol intake.
12049841|NCT00201136|Behavioral|MD CQI-type intervention|CQI-type intervention for MD adherence to JNC guidelines for BP management
12049842|NCT00201123|Drug|Aerosol Interferon-Gamma|Participants will receive aerosol interferon-gamma.
12049843|NCT00201123|Drug|Subcutaneous interferon-gamma|Patients will receive subcutaneous interferon-gamma
12049844|NCT00201123|Other|Placebo|
12049845|NCT00201110|Behavioral|Problem Solving Skills|Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
12049846|NCT00201110|Behavioral|Problem Solving Skills|Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
12049847|NCT00201084|Behavioral|Uncertainty reduction|At physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling
12049848|NCT00201058|Behavioral|Tailored Web-based Asthma Management|Web-based asthma management
12049849|NCT00201058|Behavioral|Generic web-based asthma education|4 computer sessions over a period of 180 days
12049850|NCT00201045|Other|Physician/Pharmacist Collaborative Teams|The patient's physician collaborates with a clinical pharmacist to improve management of hypertension
12049851|NCT00201019|Behavioral|Physician-pharmacist collaborative intervention|Participants receive assessment and medication and lifestyle recommendations from a clinical pharmacist.
12049852|NCT00201006|Behavioral|Face-to-face counseling|Biweekly group behavioral counseling sessions conducted in a face-to-face format
12049853|NCT00201006|Behavioral|Telephone counseling|Biweekly telephone counseling sessions conducted in a one-on-one format
12049854|NCT00201006|Other|Mail contact|Biweekly written newsletters with weight management advice delivered via U.S. mail
12049855|NCT00200993|Behavioral|physical activity|
12049856|NCT00200967|Drug|salmeterol|50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina)
12050115|NCT00199017|Procedure|CNS irradiation|
12049857|NCT00200967|Drug|beclomethasone HFA|240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)
12049858|NCT00200954|Dietary Supplement|Probiotic bacteria|3 x 10e9 CFU of a mixture of probiotic bacteria, once daily to the pregnant mothers last 6 weeks of pregnancy.To their offspring during the first year of life.
12049859|NCT00200954|Dietary Supplement|Placebo|The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
12049860|NCT00200941|Drug|Topiramate|
12049861|NCT00200928|Biological|BCG|
12049862|NCT00200902|Drug|Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)|Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
12049863|NCT00200902|Other|Placebo|Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
12049864|NCT00200902|Behavioral|Interpersonal Clinical Interaction (ICI)|Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
12049865|NCT00200889|Device|active auricular tVNS|non-painful active auricular tVNS will be delivered to the left ear
12049866|NCT00200889|Device|inactive auricular tVNS|non-painful inactive auricular tVNS will be delivered to the left ear
12049867|NCT00200876|Procedure|Hypertonic saline|To elicit pain
12049868|NCT00200876|Procedure|Isotonic saline|Non-painful control
12049869|NCT00200863|Device|Monochromatic visible light exposure|Monochromatic light in the visible range from 420-620 nm up to 60uW/cm2 for 6.5 hours
12049870|NCT00200850|Biological|House Dust Mite SLIT|low dose SLIT 143 Allergen Units(AU)/ml daily
12049871|NCT00200850|Biological|High dose SLIT|House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily
12049872|NCT00200850|Biological|Placebo SLIT|Placebo SLIT daily
12049873|NCT00200824|Drug|Soy Isoflavone Nutritional Supplements|
12049874|NCT00200785|Dietary Supplement|garlic powder added to ambient water|consumed 2.7 grams of garlic powder added to ambient water (equivalent to 8 grams fresh or raw garlic) in a sandwich, once a day for four weeks
12049875|NCT00200785|Dietary Supplement|garlic powder added to boiling water|consumed 2.7 grams of garlic powder added to boiling water (equivalent to 8 grams of cooked garlic) in a sandwich, once a day for four weeks
12049876|NCT00200759|Drug|Cranberry juice and capsules|
12049877|NCT00200746|Drug|Arginine|Amino Acid Arginine
12049878|NCT00200720|Behavioral|Atkins diet (low carbohydrate diet)|
12049879|NCT00200720|Behavioral|DASH diet (high carbohydrate diet)|
12049880|NCT00200707|Procedure|Intracoronary injection of autologous bone marrow mononuclear cells|
12049881|NCT00200694|Drug|ramipril 5 mg + valsartan 80 mg/day,|
12049882|NCT00200694|Drug|ramipril 10 mg + valsartan 160 mg/day,|
12049883|NCT00200694|Drug|ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.|
12049884|NCT00200681|Drug|Velcade|
12049885|NCT00200668|Drug|FDG = fluorodeoxyglucose|
12049886|NCT00200655|Drug|Pravastatin|
12049887|NCT00200655|Drug|Placebo|
12049888|NCT00200642|Device|Stretta® System|
12049889|NCT00200629|Procedure|Adenosine SPECT myocardial perfusion imaging|
12049890|NCT00200629|Procedure|Combined adenosine / exercise SPECT myocardial perfusion imaging|
12049891|NCT00200616|Procedure|Antimicrobial prophylaxis|
12049892|NCT00200603|Device|calcium phosphate macroporous bioceramics|
12049893|NCT00200590|Drug|acetaminophen and nalbuphine|
12049894|NCT00200590|Drug|acetaminophen and morphine|
12049895|NCT00200590|Drug|acetaminophen and reduced dosage of prostaglandin|
12049896|NCT00200577|Drug|TIL + IL2|Patients are treated with 2 injections Of TIL (1st injection M1 and the second M2)The received concomitant IL2 at M1 and M2 on days Jo (injection TIL) to J5 and J8 to J12
12049897|NCT00200564|Drug|ketamine|
12049898|NCT00200551|Drug|Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids.|
12049899|NCT00200551|Drug|Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.|
12049900|NCT00200538|Drug|memantine|
12049901|NCT00200525|Drug|apomorphine HCl injection|
12049902|NCT00200512|Drug|apomorphine HCl injection|
12049903|NCT00200499|Drug|Nebivolol|
12049904|NCT00200473|Drug|Nebivolol|
12049905|NCT00200460|Drug|Nebivolol|
12049906|NCT00200447|Drug|carbidopa/l-dopa|
12049907|NCT00200447|Drug|carbidopa/l-dopa/entacapone|
12049908|NCT00200447|Drug|Stalevo|
12049909|NCT00200447|Procedure|[123I]-IBZM imaging|
12049910|NCT00200434|Drug|Nebivolol|
12049911|NCT00200421|Drug|Nebivolol and Atenolol|
12049912|NCT00200395|Drug|Tarceva|OSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively.
12049913|NCT00200382|Drug|PS-341 (Velcade-drug)|
12049914|NCT00200369|Device|MEMS cap|
12050116|NCT00199017|Procedure|Mediastinal irradiation|
12049915|NCT00200356|Drug|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
12049916|NCT00200356|Drug|Sodium Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
12049917|NCT00200343|Drug|Ursodeoxycholic acid 150mg / day|Ursodeoxycholic acid, 150mg/ day, three times a day at meals
12049918|NCT00200343|Drug|Ursodeoxycholic acid 600mg / day|Ursodeoxycholic acid, 600mg/ day, three times a day at meals
12049919|NCT00200343|Drug|Ursodeoxycholic acid 900mg / day|Ursodeoxycholic acid, 900mg/ day, three times a day at meals
12049920|NCT00200330|Behavioral|Behavioral weight loss treatment|
12049921|NCT00200330|Behavioral|Behavioral and home environment weight loss treatment|
12049922|NCT00200317|Behavioral|Internet and print-based interventions|
12049923|NCT00200304|Behavioral|Internet weight loss with SlimFast and human counseling|
12049924|NCT00200304|Behavioral|Internet weight loss with SlimFast and computer counseling|
12049925|NCT00200304|Behavioral|Internet weight loss program with SlimFast|
12049926|NCT00200291|Behavioral|hypocaloric, low-fat diet|hypocaloric, low-fat diet
12049927|NCT00200278|Behavioral|PROJECT STRIDE|
12049928|NCT00200265|Behavioral|diet|diet
12049929|NCT00200252|Drug|oxytocin|
12049930|NCT00200239|Behavioral|Eating breakfast with portion and unportioned foods|Behavioral: eating breakfast with portion and unportioned foods
12049931|NCT00200226|Drug|misoprostol|misoprostol 400mcg 12 hrs prior to procedure
12049932|NCT00200226|Drug|vitamin B6|Vitamin B6 50 mg orally 12 hrs prior to procedure
12049933|NCT00200213|Behavioral|portion or unportioned food|
12049934|NCT00200200|Drug|Bevacizumab HAI plus systemic chemotherapy|Oxaliplatin (mg/m2) IV, over 2 hours, 5 FU (mg/m2) continuous infusion, over two days, leucovorin (mg/m2) IV, over 2 hours
12049935|NCT00200200|Drug|HAI plus systemic chemotherapy|Irinotecan (mg/m2) IV, over 30 minutes, 5 FU (mg/m2) continuous infusion over two days, leucovorin (mg/m2) IV, over 30 minutes
12049936|NCT00200187|Procedure|low venous pressure general anesthesia|
12049937|NCT00200187|Procedure|combined spinal-epidural anesthesia|
12049938|NCT00200174|Drug|Raloxifene followed by combination therapy|Patients will be randomized to either Raloxifene at 60mg P.O. (each day) for 2 weeks (time designated: week- 2) After two weeks of single agent therapy, patients will be started on combination therapy with oral raloxifene (60mg/day) and oral exemestane (25mg/day) (time designated week 0), and continued on both drugs for one year (month 12). Patients will be required to start supplemental calcium (900-1500 mg/day) plus vitamin D (400-600 units/day) P.O. each day during week 0.
12049939|NCT00200174|Drug|Exemestane followed by combination therapy|Patients will be randomized to Exemestane at 25mg P.O. for 2 weeks (time designated: week- 2) After two weeks of single agent therapy, patients will be started on combination therapy with oral raloxifene (60mg/day) and oral exemestane (25mg/day) (time designated week 0), and continued on both drugs for one year (month 12). Patients will be required to start supplemental calcium (900-1500 mg/day) plus vitamin D (400-600 units/day) P.O. each day during week 0.
12049940|NCT00200161|Drug|Temozolomide|Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
12049941|NCT00200161|Drug|Temozolomide|Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
12049942|NCT00200148|Procedure|Normovolemic Hemodilution (ANH)|For those patients randomized to ANH, the pre-calculated volume of blood will be withdrawn to a target hemoglobin of 8.0 - 8.5 g/dl (maximum of 3 L) using the formula VL=EBV x (HO-HF)/Hav, as above. The removed blood will be stored in a standard citrate-phosphate-dextrose buffer solution in blood storage bags in the operating room. During removal of blood, colloid and crystalloid solutions will be administered via peripheral intravenous lines in order to maintain euvolemia. For all patients, arterial blood will be sampled every 30 minutes during the resection for assessment of arterial blood gases/pH; Hgb levels will be measured every 30 minutes.For patients randomized to ANH, autologous blood will be re-infused in the reverse order from which it was removed, and allogeneic blood will given only after all autologous blood has been given.
12049943|NCT00200148|Procedure|Standard of care|An 8.5 French central venous catheter and an arterial line will be placed in all patients. If the patient has a central line already in place, this may be used in place of the 8.5 French internal jugular catheter. Continuous monitoring of heart rate, blood pressure, ECG (II, V5), CVP, end tidal CO2, oxygen saturation, temperature and urine output will be performed for all patients.For all hepatic resections, standard low CVP anesthetic management will be employed.For all patients, arterial blood will be sampled every 30 minutes during the resection for assessment of arterial blood gases/pH; Hgb levels will be measured every 30 minutes.All patients will receive standard postoperative management. Routine laboratory studies, including comprehensive panel, CBC and coagulation profile, will be obtained daily in the post-operative period.
12049944|NCT00200122|Device|Spinal Cord Stimulation|
12049945|NCT00200109|Device|Occipital Nerve Stimulation|Each group had a different plan
12049946|NCT00200096|Procedure|Acupuncture and questionnaires|"Acupuncture once weekly for six weeks Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Treatment scale. Patients will repeat the BFI and FACT-G at seven and eight weeks after randomization, approximately one and two weeks after their final treatment. HADS will be repeated at week seven. At the end of the study, patients will be asked to state whether they were thought they on true or placebo acupuncture and why.
~On the day of the final session of acupuncture treatment (approximately day 35), blood samples will be collected and tested for hemoglobin, thyroid function tests, as described in pretreatment evaluation. The results will be designated posttreatment values. Actigraphic monitoring will be conducted in week seven. Patients will be asked to wear the device for seven days just like during baseline evaluation."
12049993|NCT00199498|Device|Apical RV lead placement|RV lead implanted ( according to randomization )at the apex
12049947|NCT00200096|Procedure|placebo acupuncture|"During the placebo phase, placebo acupuncture needles (68) will be applied a few mm away from the points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. However, the needle does not penetrate the skin and instead moves upward inside the handle. Needles will be applied after sterile swabbing of the skin and kept in place for 20 minutes in both group.Patients in the placebo group will be offered true acupuncture after receipt of the week seven and eight fatigue diaries.
~Patients will complete the BFI, HADS and FACT-G at baseline, approximately two weeks before randomization and their first treatment. The BFI and FACT-G will be repeated after seven days, that is, one week before randomization. The use of repeat measurement decreases intrapatient variability and hence increases the precision of the baseline measure."
12049948|NCT00200083|Device|Transcend II Model 8848|"All subjects will be implanted with the IGS device and then randomized to on or off for 12 months. After 12 months all subjects will be turned on through 24 month follow up."
12049949|NCT00200070|Device|Spinal Cord Stimulation|
12049950|NCT00200057|Device|InterStim Sacral Nerve Stimulation Therapy|Open label study. All subjects that qualify for the study will be implanted.
12049951|NCT00200044|Device|Gatekeeper Reflux Repair System|The Gatekeeper System™ consists of a specialized 16-mm overtube assembly, a 2.4-mm diameter prosthesis delivery system (1-mm diameter needle, dilator, and 2.4-mm diameter sheath), a pushrod assembly and Gatekeeper Prosthesis. Up to 4 prostheses will be implanted at the initial procedure and retreatment with up to four more prostheses will be allowed at 3-months if the subject has a GERD HRQL score >15.
12049952|NCT00200031|Device|Interstim therapy|
12049953|NCT00200018|Device|Enterra Therapy System (H9900014)|
12049954|NCT00200005|Device|Type: Implantable neurostimulator; InterStim|Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.
12049955|NCT00199992|Procedure|application of autologous platelet gel|
12049956|NCT00199979|Drug|Nevirapine|
12049957|NCT00199966|Drug|Divalproex sodium extended release|
12049958|NCT00199953|Drug|Rabeprazole 20 mg twice a day for 90-day period treatment|
12049959|NCT00199940|Drug|Ziprasidone|
12049960|NCT00199927|Drug|Fluvastatin|Starting dose of Fluvastatin of 40 mg/day uptitrated to 80 mg/day
12049961|NCT00199927|Drug|standard therapy|standard therapy
12049962|NCT00199914|Device|Shortwave diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
12049963|NCT00199901|Biological|NY-ESO-1 ISCOMATRIX®|"100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.
~Each patient will receive four intramuscular injections of either NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days)."
12049964|NCT00199901|Biological|ISCOMATRIX® adjuvant|"120 μg of ISCOMATRIX® alone.
~Each patient will receive four intramuscular injections of either NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days)."
12049965|NCT00199888|Drug|124-Iodine-cG250 (124I-cG250)|
12049966|NCT00199875|Drug|Yttrium-90 conjugated chimeric G250 (^90Y-DOTA-cG250)|Patients received a single infusion of ^90Y-DOTA-cG250, with escalating doses administered to sequentially enrolled cohorts until MTD determination.
12049967|NCT00199862|Drug|Iodine-124 labeled humanized A33 (antibody)|Patients will receive a single intravenous or intraarterial infusion of 10mg huA33, labeled with 4mCi-10mCi of 124I in 5-30ml of 5% HSA in normal saline (NS), over 5-10 minutes. On study days 2, 3, and/or 4 patients will have the option to receive up to 2g/kg of IVIG. Patients will be evaluated with 124I-huA33 positron-emission tomography (PET) with ex vivo quantitation of tumor uptake.
12049968|NCT00199849|Biological|NY-ESO-1 plasmid DNA Cancer Vaccine|
12049969|NCT00199836|Biological|NY-ESO-1b peptide plus CpG 7909 and Montanide ISA-51|
12049970|NCT00199823|Genetic|Intracoronary aotologous stem cell transplantation|
12049971|NCT00199797|Drug|huA33 antibody plus chemotherapy|"huA33 will be administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2. Every second week, Oxaliplatin, 5-FU and Leucovorin are administered additionally. Oxaliplatin and Leucovorin will be given as an infusion over 2 hours. Afterwards patients will receive an bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
~The doses of Oxaliplatin will be 85mg/m2, Leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as an continuous infusion. A complete treatment cycle consists of 12 weekly treatment days."
12049972|NCT00199784|Drug|Phenylephrine|
12049973|NCT00199771|Drug|7.5% NaCl in 6% dextran 70 solution|
12049974|NCT00199758|Drug|cisplatin|
12049975|NCT00199758|Drug|Gemcitabine|
12049976|NCT00199758|Drug|Taxol|
12049977|NCT00199745|Drug|atorvastatin|
12049978|NCT00199719|Drug|Ribavirine|
12049979|NCT00199706|Drug|7.2% NaCl in 6% hydroxyethyl starch solution|
12049980|NCT00199680|Procedure|PET|
12049981|NCT00199667|Drug|Mycophenolate Mofetil|
12049982|NCT00199654|Procedure|PET|
12049983|NCT00199641|Device|enteral nutrition|
12049984|NCT00199615|Procedure|PET|Intravenous injection of glucose labeled Fluor 18.Le patient remains fasted at least 6 hours before the start of the examination. The review lasted 1 hour, during which the patient should not move.
12049985|NCT00199602|Drug|warfarine - low molecular heparin|
12049986|NCT00199589|Drug|Botulinic toxin (Botox)|Patients may benefit, depending on the draw, in addition to their orthosis, intramuscular injections of botulinum toxin.These injections are among 6 in the muscles posterior (rear) of the leg paralyzed with tracking electromyographic to ensure the accuracy of the injection.
12049987|NCT00199576|Drug|Methylprednisolone|
12049988|NCT00199563|Drug|Viagra|Sildenafil 100mg daily for 12 weeks
12049989|NCT00199550|Procedure|Bipolar Transurethral Resection of the Prostate|Bipolar TURP
12049990|NCT00199550|Procedure|Monopolar Transurethral Resection of the Prostate|Monopolar TURP
12049991|NCT00199524|Device|Navigator Ureteral Access Sheath|ureteral access sheath
12049992|NCT00199511|Drug|Administration of Hypertonic Solution 7.5% vs Mannitol 20%|
12050104|NCT00199017|Drug|Daunorubicin|
12049994|NCT00199498|Device|Septal RV lead placement|RV lead is implanted (according to randomization), on septum
12049995|NCT00199485|Drug|Angelica Sinensis|Angelica Sinensis / placebo
12049996|NCT00199472|Procedure|Dynamic Contrast Enhanced CT & Diuretic Renogram|
12049997|NCT00199446|Drug|Istradefylline (KW-6002)|
12049998|NCT00199433|Drug|Istradefylline (KW-6002)|
12049999|NCT00199420|Drug|Istradefylline (KW-6002)|
12050000|NCT00199407|Drug|Istradefylline (KW-6002)|
12050001|NCT00199394|Drug|Istradefylline (KW-6002)|
12050002|NCT00199381|Drug|Istradefylline|Oral istradefylline (KW-6002) 20 or 40 mg once daily.
12050003|NCT00199368|Drug|Istradefylline ( KW-6002)|
12050004|NCT00199355|Drug|Istradefylline (KW-6002)|
12050005|NCT00199342|Drug|KW-2871|potentially therapeutic monoclonal antibody for the treatment of advanced stage four melanoma
12050006|NCT00199329|Drug|ondansetron adding in PCA|
12050007|NCT00199316|Drug|spinal morphine|
12050008|NCT00199303|Drug|pre-operatively followed by 30 mg three times per day after surgery|
12050009|NCT00199290|Drug|Trafermin (genetical recombination)|
12050010|NCT00199277|Drug|i.v. iron sucrose|
12050011|NCT00199277|Drug|Oral iron|
12050012|NCT00199264|Drug|Albaconazole oral solution|
12050013|NCT00199251|Drug|RUPATADINE|
12050014|NCT00199238|Drug|RUPATADINE (ANTI-HISTAMINE)|
12050015|NCT00199225|Drug|Rupatadine|
12050016|NCT00199225|Drug|moxifloxacin|
12050017|NCT00199225|Procedure|Continous electrocardiographic register|
12050018|NCT00199225|Procedure|Pharmacokinetic profile|
12050019|NCT00199212|Drug|Combination of trastuzumab and PS-341|Trastuzumab and velcade are used according standard procedure
12050020|NCT00199186|Drug|imatinib|
12050021|NCT00199186|Drug|vincristine|
12050022|NCT00199186|Drug|cyclophosphamide|
12050023|NCT00199186|Drug|cytosine arabinoside|
12050024|NCT00199186|Drug|dexamethasone|
12050025|NCT00199186|Drug|idarubicin|
12050026|NCT00199186|Drug|methotrexate (intrathecal)|
12050027|NCT00199186|Drug|AraC (intrathecal)|
12050028|NCT00199186|Drug|dexamethasone (intrathecal)|
12050029|NCT00199173|Device|SIR Spheres intra-arterial hepatic|
12050030|NCT00199160|Drug|BAY 43-9006|
12050031|NCT00199147|Drug|Cytarabine|
12050032|NCT00199147|Drug|Etoposide|
12050033|NCT00199147|Drug|Idarubicin|
12050034|NCT00199147|Drug|G-CSF|
12050035|NCT00199147|Drug|Fludarabine|
12050036|NCT00199147|Procedure|Stem cell apheresis|
12050037|NCT00199147|Procedure|Stem cell transplantation|
12050038|NCT00199134|Drug|Letrozole|Size of the tumor is followed
12050039|NCT00199121|Drug|Zidovudine (drug)|
12050040|NCT00199108|Drug|Depocyt|
12050041|NCT00199108|Drug|Dexamethasone|
12050042|NCT00199095|Drug|Adriamycin|
12050043|NCT00199095|Drug|Cyclophosphamide|
12050044|NCT00199095|Drug|Cytarabine|
12050045|NCT00199095|Drug|Dexamethasone|
12050046|NCT00199095|Drug|Idarubicin|
12050047|NCT00199095|Drug|Ifosfamide|
12050048|NCT00199095|Drug|Methotrexate|
12050049|NCT00199095|Drug|Mercaptopurine|
12050050|NCT00199095|Drug|VM26|
12050051|NCT00199095|Drug|Vincristine|
12050052|NCT00199082|Drug|Adriamycin|
12050053|NCT00199082|Drug|Cyclophosphamide|
12050054|NCT00199082|Drug|Cytarabine|
12050055|NCT00199082|Drug|Dexamethasone/Prednisolone|
12050056|NCT00199082|Drug|VP16|
12050057|NCT00199082|Drug|Ifosfamide|
12050058|NCT00199082|Drug|Methotrexate|
12050059|NCT00199082|Drug|G-CSF|
12050060|NCT00199082|Drug|Rituximab|
12050061|NCT00199082|Drug|Vincristine/Vindesine|
12050062|NCT00199082|Procedure|Irradiation (in specific conditions)|
12050063|NCT00199069|Drug|Asparaginase|
12050064|NCT00199069|Drug|Vincristine|
12050065|NCT00199069|Drug|Daunorubicin, Adriamycin|
12050066|NCT00199069|Drug|Cyclophosphamide|
12050067|NCT00199069|Drug|Ifosfamide|
12050068|NCT00199069|Drug|Cytarabine|
12050069|NCT00199069|Drug|Mitoxantrone|
12050070|NCT00199069|Drug|Methotrexate|
12050071|NCT00199069|Drug|6-Mercaptopurine|
12050072|NCT00199069|Drug|6-Thioguanine|
12050073|NCT00199069|Drug|VM26|
12050074|NCT00199069|Drug|Dexamethasone / Prednisolone|
12050075|NCT00199069|Procedure|CNS Irradiation|
12050076|NCT00199069|Procedure|Mediastinal Irradiation|
12050077|NCT00199069|Procedure|Stem Cell Transplantation|
12050078|NCT00199056|Drug|Dexamethasone / Prednisolone|
12050079|NCT00199056|Drug|Cyclophosphamide|
12050080|NCT00199056|Drug|Methotrexate|
12050081|NCT00199056|Drug|Vincristine / Vindesine|
12050082|NCT00199056|Drug|Daunorubicin|
12050083|NCT00199056|Drug|Asparaginase|
12050084|NCT00199056|Drug|G-CSF|
12050085|NCT00199056|Drug|Cytarabine|
12050086|NCT00199056|Drug|6-Mercaptopurine|
12050087|NCT00199056|Drug|VP16|
12050088|NCT00199056|Drug|Adriamycin|
12050089|NCT00199056|Drug|Thioguanine|
12050090|NCT00199056|Drug|VM26|
12050091|NCT00199056|Drug|Idarubicin|
12050092|NCT00199056|Drug|Fludarabine|
12050093|NCT00199056|Drug|Ifosfamide|
12050094|NCT00199056|Procedure|CNS irradiation|
12050095|NCT00199056|Procedure|Mediastinal irradiation (if residual tumor)|
12050096|NCT00199056|Procedure|stem cell transplantation|
12050097|NCT00199043|Drug|Allopurinol|
12050098|NCT00199043|Drug|Rasburicase|
12050099|NCT00199030|Drug|Alemtuzumab (MabCampath)|
12050100|NCT00199030|Drug|Cladribine|
12050101|NCT00199017|Drug|Dexamethasone/Prednisolone|
12050102|NCT00199017|Drug|Cyclophosphamide|
12050103|NCT00199017|Drug|Vincristine|
12050119|NCT00199004|Drug|Dexamethasone / Prednisolone|
12050120|NCT00199004|Drug|Vincristine|
12050121|NCT00199004|Drug|Daunorubicin|
12050122|NCT00199004|Drug|Asparaginase|
12050123|NCT00199004|Drug|Methotrexate|
12050124|NCT00199004|Drug|Cytarabine|
12050125|NCT00199004|Drug|Mercaptopurine|
12050126|NCT00199004|Drug|G-CSF|
12050127|NCT00199004|Drug|Vindesine|
12050128|NCT00199004|Drug|VP16|
12050129|NCT00199004|Drug|Adriamycin|
12050130|NCT00199004|Drug|Thioguanine|
12050131|NCT00199004|Drug|VM26|
12050132|NCT00199004|Drug|Rituximab|
12050133|NCT00199004|Procedure|CNS irradiation|
12050134|NCT00199004|Procedure|Mediastinal irradiation (if residual TU)|
12050135|NCT00199004|Procedure|Stem cell transplantation|
12050136|NCT00198991|Drug|Cyclophosphamide|
12050137|NCT00198991|Drug|Dexamethasone|
12050138|NCT00198991|Drug|Vincristine|
12050139|NCT00198991|Drug|daunorubicin|
12050140|NCT00198991|Drug|Asparaginase|
12050141|NCT00198991|Drug|Methotrexate|
12050142|NCT00198991|Drug|Cytarabine|
12050143|NCT00198991|Drug|Mercaptopurine|
12050144|NCT00198991|Drug|G-CSF|
12050145|NCT00198991|Drug|Vindesine|
12050146|NCT00198991|Drug|VP16|
12050147|NCT00198991|Drug|Prednisolone|
12050148|NCT00198991|Drug|Adriamycin|
12050149|NCT00198991|Drug|Thioguanine|
12050150|NCT00198991|Drug|VM26|
12050151|NCT00198991|Procedure|CNS irradiation|
12050152|NCT00198991|Procedure|Mediastinal Irradiation|
12050153|NCT00198991|Procedure|Stem cell transplantation|
12050154|NCT00198991|Drug|Idarubicin|
12050155|NCT00198991|Drug|Fludarabine|
12050156|NCT00198991|Drug|Cladribine|
12050157|NCT00198978|Drug|Cyclophosphamide|
12050158|NCT00198978|Drug|Dexamethasone / Prednisolone|
12050159|NCT00198978|Drug|Cytarabine|
12050160|NCT00198978|Drug|Idarubicin|
12050161|NCT00198978|Drug|Granulocyte-Colony-Stimulating Factor|
12050162|NCT00198978|Drug|Mercaptopurine|
12050163|NCT00198978|Drug|Methotrexate|
12050164|NCT00198978|Drug|Rituximab|
12050165|NCT00198978|Drug|HDARAC|
12050166|NCT00198978|Drug|Vincristine|
12050167|NCT00198978|Drug|Depocyte|
12050168|NCT00198978|Drug|Asparaginase|
12050169|NCT00198965|Behavioral|dietary education|
12050170|NCT00198965|Behavioral|dietary education and provided full fat snack foods|
12050171|NCT00198965|Behavioral|dietary education and provided fat free snack foods|
12050172|NCT00198952|Drug|DietPro|
12050173|NCT00198952|Drug|Placebo|
12050174|NCT00198939|Behavioral|Integrated Family and Cognitive-Behavioral Drug Prevention Intervention|The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases. The cognitive program focuses on harmful effects of drugs and strategies to better manage drug abuse risks. The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
12050175|NCT00198939|Other|Psychoeducation|Drug education curriculum was delivered to participants assigned to this condition.
12050176|NCT00198926|Behavioral|covert v overt nutrition labeling|
12050177|NCT00198926|Behavioral|varying meal nutrition manipulation|
12050178|NCT00198913|Behavioral|lower fat food supplied and education|
12050179|NCT00198913|Behavioral|gift cards for grocery foods and written education|
12050180|NCT00198900|Behavioral|survey of information|
12050181|NCT00198887|Procedure|Operations research|
12050182|NCT00198874|Behavioral|Integrated Family and Cognitive-Behavioral Therapy|The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases. The cognitive program focuses on harmful effects of drugs and strategies to better manage drug abuse risks. The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
12050183|NCT00198874|Other|Education|Drug education curriculum was delivered to participants assigned to this condition.
12050184|NCT00198861|Other|Injection and Non-Injection Drug Users|(1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors.
12050185|NCT00198848|Drug|Iron-folic acid supplement|
12050186|NCT00198835|Behavioral|Maternal nutrition and infant feeding advice|
12050187|NCT00198822|Dietary Supplement|Vitamin A or Beta-Carotene Supplements|weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy
12050188|NCT00198809|Drug|Biolean + Diet education|
12050189|NCT00198809|Drug|Biolean Free + Diet education|
12050190|NCT00198809|Drug|Placebo + Diet education|
12050191|NCT00198796|Biological|H10407|The primary objective of the proposed clinical investigation is to validate a dose for ETEC H10407 that will cause diarrhea in 50% or more of subjects without causing high output diarrhea
12050192|NCT00198770|Dietary Supplement|dietary substitution to assess level of caloric compensation|Mushrooms substituted for meat in dishes
12050193|NCT00198757|Behavioral|Medifast Plus for Diabetics Meal Replacement Supplements|
12050194|NCT00198757|Behavioral|Standard ADA recommended diet for type 2 diabetics|
12050195|NCT00198744|Behavioral|Medifast FIT! for Kids|
12050196|NCT00198744|Behavioral|standard recommendations for dietary intake in children|
12050197|NCT00198744|Behavioral|both diet plans with and without a parent dieting|
12050198|NCT00198731|Behavioral|Care Seeking for Obstetric Complication|This is a descriptive study of knowledge, practices and outcomes related to maternal morbidity during pregnancy, childbirth and postpartum.
12050199|NCT00198718|Drug|Vitamin A (retinyl palmitate)|
12050200|NCT00198705|Behavioral|Improved management of severe neonatal infections|
12050201|NCT00198692|Behavioral|self-management|
12050202|NCT00198679|Drug|Chlorhexidine|
12050203|NCT00198666|Drug|Zinc|Elemental Zinc
12050204|NCT00198653|Behavioral|Newborn Thermal Care Practice|
12050205|NCT00198640|Procedure|Antibiotic use|
12050206|NCT00198627|Drug|Co-Trimoxazole; TMP-SMZ|
12050207|NCT00198614|Drug|Carvedilol versus Metoprolol|
12050208|NCT00198601|Drug|Gentamicin in Uniject Pre-filled syringe|
12050209|NCT00198588|Drug|argatroban|beginning dose: 0.7microgram/kg/H
12050210|NCT00198562|Drug|Amlodipine, Losartan|amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
12050211|NCT00198549|Drug|Vitrase (ovine hyaluronidase) Lyophilized|
12050212|NCT00198536|Drug|Ecabet 2.83%|
12050213|NCT00198536|Drug|Ecabet 3.70%|
12050214|NCT00198536|Drug|Vehicle|
12050215|NCT00198523|Drug|Prednisolone and Tobramycin|
12050216|NCT00198523|Drug|Prednisolone|
12050217|NCT00198510|Drug|Vitrase|7.5 IU of Vitrase
12050218|NCT00198510|Drug|Vitrase|55 IU of Vitrase
12050219|NCT00198510|Drug|Vitrase|75 IU of Vitrase
12050220|NCT00198497|Drug|Placebo|
12050221|NCT00198497|Drug|Vitrase|Hyaluronidase 55 IU in saline solution
12050222|NCT00198497|Drug|Vitrase|Hyaluronidase 75 IU in saline solution
12050223|NCT00198484|Drug|Vitrase|
12050224|NCT00198471|Drug|Vitrase|
12050225|NCT00198458|Drug|Vitrase|
12050226|NCT00198445|Drug|Bromfenac|One drop in study eye every 12 hours for 14 days
12050227|NCT00198445|Drug|Placebo|One drop in study eye every 12 hours for 14 days
12050228|NCT00198432|Drug|Paclitaxel, vinorelbine, cisplatin|
12050229|NCT00198419|Drug|Vitrase|
12050230|NCT00198406|Procedure|diagnostic and therapeutic management|
12050231|NCT00198393|Drug|Gefitinib|250 mg/day, until progression
12050232|NCT00198393|Drug|gemcitabine|1250 mg/m² D1 and D8 (D1=D28, until progression)
12050233|NCT00198393|Drug|Docetaxel|75 mg/m² D1 (D1=D22, until progression)
12050234|NCT00198380|Drug|Gefitinib|Gefitinib 250 mg/day, until progression or severe toxicity
12050235|NCT00198367|Drug|Cisplatin-Gemzar|
12050236|NCT00198367|Drug|Cisplatin-Navelbine-Radiotherapy|
12050237|NCT00198367|Drug|Carboplatin-Taxol-Radiotherapy|
12050238|NCT00198354|Drug|gemcitabine + cisplatine|gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
12050239|NCT00198354|Drug|Paclitaxel + Carboplatine|paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
12050240|NCT00198341|Procedure|Radiological Arm|Clinical Visit + X-Ray Chest
12050241|NCT00198341|Procedure|Scannographic arm|Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)
12050242|NCT00198328|Combination Product|Medpulser Electroporation with Bleomycin|Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.
12050243|NCT00198328|Procedure|Surgical Excision|Patients have their tumor surgically removed.
12050244|NCT00198315|Combination Product|Medpulser electroporation with Bleomycin|Patients receive electroporation with injection of bleomycin sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.
12050245|NCT00198315|Procedure|Tumor surgical excision|Patients have their tumor surgically removed.
12050246|NCT00198302|Drug|Aurexis®|
12050247|NCT00198289|Drug|Aurexis® (tefibazumab)|
12050248|NCT00198276|Combination Product|MedPulser Electroporation with bleomycin|The MedPulser device will be used in combination with Bleomycin Sulfate injection around the tumor area in a concentration of 1 U/ml per cm3 of tumor treatment area.
12050249|NCT00198263|Combination Product|Medpulser Electroporation with Bleomycin|The MedPulser device will be used in conjunction with injection of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.
12050250|NCT00198250|Drug|venlafaxine|Venlafaxine taper dose from 37.5mg for one week to 75 mg for 3 weeks
12050251|NCT00198237|Drug|docetaxel & capecitabine|
12050252|NCT00198224|Procedure|phlebotomy|
12050253|NCT00198198|Drug|Aripiprazole|
12050254|NCT00198185|Procedure|Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery|
12050255|NCT00198172|Drug|Cisplatin plus Epirubicin|
12050256|NCT00198159|Drug|ZD1839 Iressa|
12050257|NCT00198146|Drug|Zenapax|
12050258|NCT00198133|Drug|Premetrexed (Alimta)|Pemetrexed will be 500 mg/m2 IV every 3 weeks
12050259|NCT00198120|Drug|D-cycloserine|D-Cycloserine 0.6mg/kg/day in week 1 D-Cycloserine 1.1mg/kg/day in week 2 D-Cycloserine 1.7mg/kg/day in week 3-8 Flexible dosing based on response. Capsule Strength: 10mg, 20mg
12050260|NCT00198120|Drug|Placebo|Placebo: same dosing schedule and capsule strength
12050261|NCT00198107|Drug|Aripiprazole|Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 kg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
12050262|NCT00198107|Drug|Placebo|Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
12050263|NCT00198107|Drug|D-cycloserine|D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
12050264|NCT00198094|Drug|Sertraline and Alprazolam XR|
12050265|NCT00198081|Drug|COX-2 Inhibitor 6-8 weeks prior to surgery|400 mg BID 6-8 weeks prior to surgery
12050266|NCT00198081|Drug|COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP|400 mg BID for 6 months prior to follow-up EUS or ERCP
12050267|NCT00198055|Drug|aripiprazole|Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.
12050268|NCT00198042|Procedure|Surgical reconstruction of the ACL|Surgical reconstruction of the ACL
12050463|NCT00196339|Drug|Cyproterone acetate 15|Cyproterone acetate 15 mg
12050464|NCT00196339|Drug|Cyproterone acetate 25|Cyproterone acetate 25 mg
12050269|NCT00198029|Device|Synvisc (hylan G-F20)|32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection
12050270|NCT00198016|Device|Coil|
12050271|NCT00198003|Behavioral|Educational program to address patients' expectations|
12050272|NCT00197977|Behavioral|Educational program to address patients' expectations|
12050273|NCT00197964|Behavioral|Enhance asthma knowledge, self-efficacy, social support|
12050274|NCT00197951|Drug|Treatment of psychiatric symptoms associated to alcoholism|
12050275|NCT00197938|Procedure|Measurement of rectal lactic acid.|
12050276|NCT00197925|Biological|Onco-peptide loaded autologous dendritic cells|
12050277|NCT00197912|Biological|tumor antigen loaded autologous dendritic cells|DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with p53, survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate pulsed dendritic cells. 50 mg cyclophosphamide (Sendoxan®, Baxter A/S) is administered p.o. twice a day bi-weekly and 200 mg celecoxib (Celebra®, Pfizer) is given p.o. every day. From the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.
12050278|NCT00197899|Drug|E. Coli endotoxin|
12050279|NCT00197886|Drug|Changing dose of norepinephrine and blood pressure|
12050280|NCT00197873|Dietary Supplement|Lactobacillus Rhamnosus supplementation|Lactophilus supplementation is administered during chemotherapy.
12050281|NCT00197873|Other|Placebo administration.|Placebo is administered during chemotherapy.
12050282|NCT00197860|Biological|tumor antigen loaded autologous dendritic cells|DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate-pulsed dendritic cells i.d. 1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week and from the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.
12050283|NCT00197834|Drug|Depakote|
12050284|NCT00197821|Biological|pneumococcal conjugate vaccine|Pneumococcal conjugate vaccine
12050285|NCT00197808|Biological|menjugate|men C conjugate vaccine
12050286|NCT00197808|Biological|Men C conjugate vaccine|men C conjugate vaccine
12050287|NCT00197808|Biological|Men C conjugate|men C conjugate vaccine
12050288|NCT00197808|Biological|Men C Conjugate|men C conjugate vaccine
12050289|NCT00197808|Biological|Men C conjugate|men C conjugate vaccine
12050290|NCT00197808|Biological|Men C conjugate|men C conjugate vaccine
12050291|NCT00197795|Biological|"Meningococcal outer membrane vesicle vaccine MenBVac"|
12050292|NCT00197782|Biological|Hib conjugate vaccine|
12050293|NCT00197769|Biological|9 valent pneumococcal con jugate vaccine|
12050294|NCT00197756|Dietary Supplement|Vitamin A alone|30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
12050295|NCT00197756|Dietary Supplement|Multivitamins excluding vitamin A|30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation
12050296|NCT00197756|Dietary Supplement|multivitamins including vitamin A|20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation
12050297|NCT00197756|Other|Placebo|Placebo pill taken orally once per day during pregnancy and lactation
12050298|NCT00197743|Dietary Supplement|Vitamin A + Beta Carotene|one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
12050299|NCT00197743|Dietary Supplement|Multivitamins|one daily oral dose of 20 mg thiamine (vitamin B-1), 20 mg riboflavin (vitamin B-2), 25 mg vitamin B-6, 100 mg niacin, 50 ug cobalamin (vitamin B-12), 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid
12050300|NCT00197743|Other|Placebo|Placebo pill
12050301|NCT00197730|Drug|Multivitamins - vitamins B complex, C and E|Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months
12050302|NCT00197730|Drug|Placebo|Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months
12050303|NCT00197704|Dietary Supplement|Multivitamins|5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
12050304|NCT00197704|Other|Placebo|Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
12050305|NCT00197691|Procedure|blood draws, etc.|
12050306|NCT00197678|Dietary Supplement|Multivitamins-Multiples of RDA|20 mg B1, 20 mg B2, 25 mg B6, 50 mcg B12, 100 mg niacin, 500 mg C, 30 mg E, 0.8 mg folic acid taken orally once per day until 6 weeks after delivery
12050307|NCT00197678|Dietary Supplement|Multivitamins-Single RDA|1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 50 mcg B12, 100 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid taken orally once per day until 6 weeks after delivery
12050308|NCT00197639|Drug|Ritonavir-boosted indinavir|
12050309|NCT00197613|Drug|(A) zidovudine, lamivudine and nevirapine|
12050310|NCT00197613|Drug|(B) zidovudine, lamivudine and efavirenz|
12050311|NCT00197613|Drug|(C) zidovudine, didanosine, and nevirapine|
12050312|NCT00197613|Drug|(D) zidovudine, didanosine, and efavirenz|
12050313|NCT00197613|Drug|(E) stavudine, lamivudine, and nevirapine|
12050314|NCT00197613|Drug|(F) stavudine, lamivudine and efavirenz|
12050315|NCT00197613|Procedure|Adherence Strategy Standard of Care (SOC)|
12050316|NCT00197613|Procedure|Adherence Strategy Community-Based DOT|
12050317|NCT00197587|Drug|Nevirapine|All women received a background of zidovudine from 34 weeks' gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.
12050693|NCT00194467|Drug|placebo|matching placebo, once a day for 8 weeks
12050318|NCT00197587|Drug|No intervention|All women received a background of zidovudine from 34 weeks'gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.
12050319|NCT00197561|Dietary Supplement|Placebo|Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
12050320|NCT00197561|Dietary Supplement|Selenium|200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery
12050321|NCT00197548|Dietary Supplement|Multivitamins-vitamins B-complex, C, and E|One daily oral dose of 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 mg of C, and 30 mg of vitamin E from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
12050322|NCT00197548|Dietary Supplement|Placebo|One daily oral dose of a placebo pill taken from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
12050323|NCT00197522|Biological|CD34+ derived DCs|
12050324|NCT00197509|Behavioral|Sit-To-Stand Protocol and Extra Practice in Sit-To-Stand|
12050325|NCT00197496|Procedure|Body weight supported treadmill training|hip fracture patients walk on a treadmill with body weight support
12050326|NCT00197483|Drug|Pergolide (drug)|
12050327|NCT00197470|Procedure|IL-1, TNF-alpha, Il-10|
12050328|NCT00197457|Procedure|serum pepsinogen|
12050329|NCT00197457|Procedure|urea breath test|
12050330|NCT00197444|Drug|CDGP/5-FU combined with radiation|Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26.
12050331|NCT00197444|Radiation|Radiotherapy|Fractionated external radiotherapy was performed from the first day of chemotherapy and a total dose of 50.4-66 Gy was delivered at the rate of 1.8-2.0 Gy per fraction.
12050332|NCT00197431|Drug|S-1|
12050333|NCT00197418|Drug|rabeprazole, amoxicillin, clarithromycin, metronidazole|
12050334|NCT00197392|Device|Bactiseal TM EVD|Standard of care implantation of external ventricular drainage catheter
12050335|NCT00197392|Device|Standard EVD Catheter|Standard of care EVD system other than Bactiseal.
12050336|NCT00197379|Drug|roxithromycin|
12050337|NCT00197353|Drug|Epidural bupivacaine (dose/concentration/volume ranging)|
12050338|NCT00197340|Drug|Epidural ropivacaine|
12050339|NCT00197327|Drug|Epidural bupivacaine (0.25% versus 0.0625%)|
12050340|NCT00197314|Behavioral|circular muscle exercises versus pelvic floor exercises|
12050341|NCT00197301|Biological|Vaccination|
12050342|NCT00197288|Biological|Influenza|
12050343|NCT00197275|Biological|Hib-MenAC mixed with Tritanrix™-HepB|
12050344|NCT00197262|Drug|GW685698X Aqueous Nasal Spray|
12050345|NCT00197249|Biological|Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix|
12050346|NCT00197236|Biological|Havrix™|2 intramuscular injections, 6 months apart
12050347|NCT00197236|Biological|Infanrix™|1 intramuscular injection
12050348|NCT00197236|Biological|ActHIB™|1 intramuscular injection
12050349|NCT00197223|Biological|Influenza vaccine|
12050350|NCT00197210|Biological|Rotavirus|
12050351|NCT00197197|Drug|GW873140|
12050352|NCT00197184|Biological|Twinrix™ Adult|Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
12050353|NCT00197184|Biological|Twinrix™ Junior|Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
12050354|NCT00197171|Biological|Combined Hepatitis A and B vaccine|
12050355|NCT00197158|Biological|Hepatitis B vaccine|
12050356|NCT00197145|Drug|GW873140|400 mg twice daily
12050357|NCT00197132|Drug|Avandia|
12050358|NCT00197119|Biological|Twinrix™ Adult|Intramuscular administration in the deltoid region (2 doses).
12050359|NCT00197119|Biological|Twinrix™ Junior|Intramuscular administration in the deltoid region (3 doses).
12050360|NCT00197106|Drug|Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg|comparator
12050361|NCT00197106|Drug|fluticasone propionate 2 x 100 mcg|comparator
12050362|NCT00197093|Drug|SB773812|
12050363|NCT00197080|Drug|Ropinirole Extended Release (XR)|
12050364|NCT00197067|Biological|RTS,S/AS02D and RTS,S/AS02A|
12050365|NCT00197054|Biological|RTS, S/AS01B|0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
12050366|NCT00197054|Biological|RTS, S/AS02A|0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
12050367|NCT00197054|Biological|Rabipur (Rabies) Vaccine|1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
12050368|NCT00197041|Biological|RTS,S/AS02A|
12050369|NCT00197028|Biological|RTS,S/AS02D|3-dose intramuscular injection in the thigh
12050370|NCT00197028|Biological|TETRActHib™|3-dose intramuscular injection in the thigh.
12050371|NCT00197028|Biological|Engerix-B®|3-dose intramuscular injection in the thigh.
12050372|NCT00197015|Biological|Havrix®|2 doses administered intramuscularly
12050373|NCT00197015|Biological|M-M-R®II|1 dose administered subcutaneously
12050374|NCT00197015|Biological|VARIVAX®|1 dose administered subcutaneously
12050375|NCT00197002|Biological|GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)|Two doses, administered intramuscularly in the right anterolateral thigh.
12050376|NCT00197002|Biological|Prevnar™|One dose, administered intramuscularly in the left anterolateral thigh.
12050377|NCT00196989|Drug|Pioglitazone|
12050378|NCT00196989|Drug|GW677954|
12050379|NCT00196976|Biological|Conjugated meningococcal ACWY-TT (vaccine)|One intramuscular dose during the primary vaccination
12050380|NCT00196976|Biological|DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)|One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
12050821|NCT00193427|Drug|Carboplatin|AUC = 1.5 weekly x 7
12050381|NCT00196976|Biological|DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)|One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
12050382|NCT00196976|Biological|Meningitec™|One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
12050383|NCT00196976|Biological|Mencevax™ACWY|One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
12050384|NCT00196963|Biological|Meningococcal (vaccine)|
12050385|NCT00196950|Biological|Meningococcal (vaccine)|
12050386|NCT00196937|Biological|Cervarix|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
12050387|NCT00196924|Biological|HPV-16/18 L1/AS04|
12050388|NCT00196911|Procedure|Implantation of stimulation electrodes in the STN|
12050389|NCT00196885|Drug|N-acetylcysteine|
12050390|NCT00196872|Drug|Epirubicine|Epirbubicne is given
12050391|NCT00196872|Drug|Cyclophosphamide|Cyclophosphamide is given
12050392|NCT00196872|Drug|Taxol|Taxol is given
12050393|NCT00196872|Drug|Xeloda|Xeloda is given
12050394|NCT00196872|Drug|Ibandronat|Ibandronat is given
12050395|NCT00196859|Drug|Ibandronate, Capecitabine|Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs plus Capecitabine 2000 mg/m2 days 1-14 q d22 x6
12050396|NCT00196859|Drug|Ibandronate|Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs
12050397|NCT00196846|Drug|Goserelin|
12050398|NCT00196820|Drug|Capecitabine|
12050399|NCT00196807|Behavioral|patient decision aid (print-based)|To evaluate the impact of the decision aid intervention (information plus decision aid (IDA) vs. usual care (UC)), and timing of intervention delivery (at Home (pre-screening) vs. in the Clinic (screening day)) on key patient outcome variables of PCa knowledge and decisional satisfaction.
12050400|NCT00196794|Drug|Tolevamer potassium-sodium (GT267-004)|
12050401|NCT00196781|Behavioral|CD-ROM-based prostate cancer treatment education|The goal was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.
12050402|NCT00196781|Behavioral|CD-ROM-based prostate ca treatment education+decision tools|The goal of the present study was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.
12050403|NCT00196768|Drug|Arsenic trioxide|
12050404|NCT00196768|Drug|Trisenox|
12050405|NCT00196755|Drug|Sevelamer Hydrochloride (Renagel®)|Sevelamer hydrochloride three times per day with each meal
12050406|NCT00196755|Drug|Calcium acetate (PhosLo® )|Calcium acetate three times per day with each meal
12050407|NCT00196729|Drug|Thyrogen + Radioiodine (131I)|
12050408|NCT00196716|Biological|Fabrazyme (agalsidase beta)|1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months
12050409|NCT00196703|Drug|memantine|
12050410|NCT00196703|Procedure|constraint-induced language therapy|
12050411|NCT00196690|Drug|Donepezil|
12050412|NCT00196677|Drug|Vitamins, minerals and medical herbs|
12050413|NCT00196664|Drug|Paroxetine|
12050414|NCT00196651|Drug|IL-2|
12050415|NCT00196651|Biological|LIPO-6T|
12050416|NCT00196651|Biological|ALVAC VIH 1433|
12050417|NCT00196638|Drug|Antiretroviral combination (drugs)|
12050418|NCT00196638|Drug|Pegylated Interferon alpha (drug)|
12050419|NCT00196625|Drug|Amprenavir (drug)|
12050420|NCT00196625|Drug|ABT-378/r (drug)|
12050421|NCT00196625|Drug|Ritonavir (drug)|
12050422|NCT00196612|Drug|emtricitabine, FTC (drug)|
12050423|NCT00196612|Drug|didanosine, ddI (drug)|
12050424|NCT00196612|Drug|efavirenz (drug)|
12050425|NCT00196599|Drug|emtricitabine, FTC (drug)|
12050426|NCT00196599|Drug|didanosine, ddI (drug)|
12050427|NCT00196599|Drug|efavirenz (drug)|
12050428|NCT00196586|Drug|Interleukin 2|
12050429|NCT00196586|Drug|pegylated interferon alpha 2a|
12050430|NCT00196586|Drug|ribavirin|
12050431|NCT00196573|Procedure|Shoulder bursectomy alone|
12050432|NCT00196560|Device|Immobilization in External Rotation|
12050433|NCT00196547|Drug|Montelukast (drug)|
12050434|NCT00196534|Drug|Human Thrombin|
12050435|NCT00196534|Drug|Bovine Thrombin|
12050436|NCT00196521|Device|Tension-free vaginal tape obturator system|
12050437|NCT00196508|Device|High Viscosity DERMABOND|
12050438|NCT00196495|Device|Polypropylene Mesh|
12050439|NCT00196482|Drug|changing of fortifier|
12050440|NCT00196469|Drug|heparin|
12050441|NCT00196456|Procedure|photosensitisation|
12050442|NCT00196443|Device|urea contained compressing stockings|
12050443|NCT00196443|Device|compressing stockings|
12050444|NCT00196430|Device|silver-contained textiles|
12050445|NCT00196430|Drug|corticosteroid|
12050446|NCT00196417|Drug|Standard heparin (UFH) versus certoparin (LMWH)|
12050447|NCT00196404|Drug|DR-3001a|4mg daily vaginally
12050448|NCT00196404|Drug|DR-3001b|6 mg vaginally daily
12050449|NCT00196404|Other|Placebo|Administered vaginally to match experimental arms
12050450|NCT00196391|Drug|DR-2021a|1 capsule daily for 10 days
12050451|NCT00196391|Drug|DR-2021b|1 capsule daily for 10 days
12050452|NCT00196391|Drug|DR-2021c|1 capsule daily for 10 days
12050453|NCT00196391|Drug|DR-2021d|1 capsule daily for 10 days
12050454|NCT00196391|Drug|DR-2021e|1 capsule daily for 10 days
12050455|NCT00196391|Other|Placebo|1 matching placebo capsule for 10 days
12050456|NCT00196378|Drug|Synthetic Conjugated estrogens, B|1 (0.3mg) tablet daily
12050457|NCT00196378|Other|Placebo|1 tablet daily
12050458|NCT00196365|Drug|levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets|1 tablet daily
12050459|NCT00196365|Drug|levonorgestrel/EE 0.15/0.03 mg tablets and placebo|1 tablet daily
12050460|NCT00196352|Drug|Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets|1 tablet daily
12050461|NCT00196339|Drug|Cyproterone acetate 5|Cyproterone acetate 5 mg
12050462|NCT00196339|Drug|Placebo|Matching placebo
12050465|NCT00196326|Drug|DR-1011|Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
12050466|NCT00196313|Drug|levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets|1 tablet daily by mouth
12050467|NCT00196313|Drug|Placebo tablet|1 tablet daily by mouth
12050468|NCT00196222|Procedure|RF-ablation|RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
12050469|NCT00196222|Procedure|cryo ablation|Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
12050470|NCT00196209|Procedure|catheter ablation|catheter ablation to treat persistent atrial fibrillation
12050471|NCT00196209|Procedure|external electric cardioversion|external cardioversion and drug prophylaxis to treat persistent atrial fibrillation
12050472|NCT00196196|Device|Codman VPV System|Valve Positioning Verification (VPV) System
12050473|NCT00196183|Procedure|trigger-guided catheter-ablation|trigger-guided ablation of paroxysmal atrial fibrillation
12050474|NCT00196183|Procedure|trigger+substrate-guided catheter ablation|trigger-+substrate guided ablation of paroxysmal atrial fibrillation
12050475|NCT00196170|Procedure|RF ablation of the cavo-tricuspid isthmus|8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
12050476|NCT00196170|Procedure|cryo ablation of the cavo-tricuspid isthmus|Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
12050477|NCT00196170|Procedure|irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus|irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
12050478|NCT00196170|Procedure|cryo 6.5mm tip ablation of the cavotricuspid isthmus|cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
12050479|NCT00196157|Procedure|linear anatomically oriented ablations|linear lesions to ablate persistent atrial fibrillation
12050480|NCT00196157|Procedure|focal electrophysiological oriented ablations|focal electrophysiologically guided ablations to treat persistent atrial fibrillation
12050481|NCT00196144|Device|Individualized Programming of PVAB|Performance of a test to detect far-field R-wave sensing
12050482|NCT00196144|Device|Nominal PVAB|nominal pacemaker settings
12050483|NCT00196131|Drug|morphine|only patients with a head injury currently receiving Morphine continuously or prm can and have an ICP drain can be enrolled into study
12050484|NCT00196118|Device|Günther Tulip Vena Cava Filter|
12050485|NCT00196105|Device|6 mm Nitinol Zilver Stent|
12050486|NCT00196105|Device|10 mm Nitinol Zilver Stent|
12050487|NCT00196105|Device|10 mm Stainless Steel Wallstent|
12050488|NCT00196092|Device|Roll-in|Proctored entry.
12050489|NCT00196092|Device|Surgical|Surgery
12050490|NCT00196092|Device|Standard Risk|Standard Endovascular repair
12050491|NCT00196092|Device|High Risk|High Risk Endovascular repair.
12050492|NCT00196092|Device|Compassionate Use|Endovascular repair for compassionate use patients.
12050493|NCT00196092|Device|Treatment for females|Endovascular repair in female patients
12050494|NCT00196092|Device|Standard Risk Continued Access|Continued Access Endovascular repair for standard risk patients.
12050495|NCT00196092|Device|High Risk Continued Access|Continued Access Endovascular Repair for High Risk Patients.
12050496|NCT00196079|Device|Coronary stent|
12050497|NCT00196066|Device|Peripheral Vessel Stenting|
12050498|NCT00196053|Device|Archimedes Constant Flow Implantable Pump|
12050499|NCT00196040|Device|PFX Closure System|
12050500|NCT00196027|Device|PFX Closure System|
12050501|NCT00195988|Drug|tacrolimus, steroids, mycophenolate mofetil|
12050502|NCT00195949|Procedure|Laparoscopic pyloromyotomy|
12050503|NCT00195936|Drug|Cinacalcet|
12050504|NCT00195923|Drug|Ampicillin, gentamicin, clindamycin, flagyl, ceftazidime|
12050505|NCT00195910|Drug|Morphine|0.1 mg/kg IV morphine
12050506|NCT00195910|Drug|Hydromorphone|0.015 mg/kg IV hydromorphone
12050507|NCT00195884|Behavioral|Aerobic and Resistance Exercise|"Aerobic activities are performed on a cycle ergometer or treadmill. Exercise intensity is standardized using Polar Heart rate monitors that display the subject's heart rate.
~Resistance training:Exercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below.
~Group A: abdominal crunches, seated row, seated biceps curls, supine bench press, leg press, shoulder press; leg extension Group B: abdominal crunches, lat pulldown, sitting chest press, leg press, upright row, triceps pushdown, leg curls.
~Combined aerobic and resistance training group will perform both aerobic and resistance training programs, as described above.
~Control: members of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program."
12050508|NCT00195871|Drug|Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide|coventional dosages
12050509|NCT00195871|Procedure|hematopoietic stem cell allograft|conventional procedures
12050510|NCT00195858|Behavioral|aerobic and resistance exercise|aerobic and resistance exercise
12050511|NCT00195845|Drug|Galantamine|
12050512|NCT00195845|Drug|Placebos|
12050513|NCT00195819|Biological|adalimumab (D2E7)|Adalimumab 40 mg every other week (eow)
12050514|NCT00195819|Biological|placebo|Placebo every other week (eow)
12050515|NCT00195806|Drug|divalproex sodium|
12050516|NCT00195793|Drug|fenofibrate|
12050517|NCT00195793|Drug|ezetimibe|
12050518|NCT00195793|Drug|atorvastatin|
12050519|NCT00195780|Drug|Divalproex Sodium (Depakote ER)|
12050520|NCT00195767|Drug|divalproex sodium|
12050521|NCT00195754|Drug|divalproex sodium|
12050522|NCT00195741|Drug|divalproex sodium|
12050523|NCT00195728|Drug|Hydrocodone/Acetaminophen on Extended Release|2 tablets twice daily
12050524|NCT00195715|Biological|Adalimumab|Adalimumab 40 mg by subcutaneous injection every other week or every week
12050525|NCT00195702|Biological|Adalimumab|Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
12050526|NCT00195702|Biological|Adalimumab|Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.
12050527|NCT00195702|Drug|Placebo|Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
12050528|NCT00195702|Biological|Adalimumab|Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
12050529|NCT00195702|Biological|Adalimumab|Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.
12050530|NCT00195702|Biological|Adalimumab|Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
12050531|NCT00195689|Biological|Human anti-TNF monoclonal antibody/adalimumab|
12050532|NCT00195676|Drug|adalimumab|40 mg every other week or 40 mg every week by subcutaneous injection
12050533|NCT00195663|Biological|Adalimumab|
12050534|NCT00195663|Drug|Methotrexate|
12050535|NCT00195663|Biological|Adalimumab placebo|
12050536|NCT00195663|Drug|Methotrexate placebo|
12050537|NCT00195650|Biological|Adalimumab|Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)
12050538|NCT00195637|Drug|Immune Globulin|
12050539|NCT00195624|Biological|Alemtuzumab (Campath )|Campath administered at a dose of 10/mg/day for 10 days
12050540|NCT00195624|Drug|Cyclosporine|Subjects who relapse after initial response to alemtuzumab therapy will have cyclosporine added to the regimen after the 6 month visit. Dosing will be based on ideal body weight and will be adjusted to maintain a target level of 200 - 400 ng /ml.
12050541|NCT00195611|Drug|Prevenar|
12050542|NCT00195598|Drug|VENLAFAXINE|
12050543|NCT00195598|Drug|Paroxetine|
12050544|NCT00195585|Drug|Isovorin|
12050545|NCT00195585|Drug|UFT|
12050546|NCT00195572|Drug|Isovorin|
12050547|NCT00195572|Drug|TS-1|
12050548|NCT00195559|Drug|Levonorgestrel/Ethinyl Estradiol|
12050549|NCT00195546|Drug|DVS-233|
12050550|NCT00195533|Drug|piperacillin-tazobactam|
12050551|NCT00195533|Drug|glycopeptide|
12050552|NCT00195520|Drug|Totelle®|
12050553|NCT00195507|Drug|Etanercept|
12050554|NCT00195494|Drug|Etanercept|"Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2
~Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2"
12050555|NCT00195494|Drug|Methotrexate|"Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2
~Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2
~Group 2b: Oral Methotrexate weekly for both Periods 1 and 2"
12050556|NCT00195494|Drug|Placebo|"Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2"
12050557|NCT00195481|Drug|Rapamune|
12050558|NCT00195468|Drug|CYCLOSPORINE|
12050559|NCT00195455|Drug|Trimegestone|
12050560|NCT00195455|Drug|17b Estradiol|
12050561|NCT00195442|Drug|Moroctocog alfa|Patients will be treated in accordance with the requirements of the labeling of ReFacto (Moroctocog alfa) in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
12050562|NCT00195429|Drug|Tacrolimus|
12050563|NCT00195429|Drug|Sirolimus|
12050564|NCT00195429|Drug|prednisone|
12050565|NCT00195416|Drug|Etanercept|Etanercept 25mg Injection, 2 times/week
12050566|NCT00195403|Drug|Etanercept|Etanercept 25mg Injection, 2 times/week
12050567|NCT00195390|Biological|Prevenar|Prevenar 0.5ml/ Vial and PFS
12050568|NCT00195377|Drug|Etanercept|
12050569|NCT00195364|Drug|Etanercept|
12050570|NCT00195351|Drug|tigecycline|every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
12050571|NCT00195351|Drug|ceftriaxone sodium + metronidazole|Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
12050572|NCT00195338|Drug|etanercept|
12050573|NCT00195325|Drug|TTI-237|
12050574|NCT00195312|Biological|HIV-1 gag DNA (formulated with bupivacaine)|
12050575|NCT00195312|Biological|IL-15 DNA (formulated with bupivacaine)|
12050576|NCT00195312|Biological|IL-12 DNA (formulated with bupivacaine)|
12050577|NCT00195312|Biological|Sodium chloride injection USP (0.9%)|
12050578|NCT00195299|Drug|Temsirolimus|
12050579|NCT00195286|Drug|piperacillin/tazobactam|
12050580|NCT00195273|Drug|sirolimus|15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
12050581|NCT00195273|Drug|cyclosporine|Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
12050582|NCT00195273|Drug|mycophenolate mofetil|1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
12050820|NCT00193427|Drug|Gemcitabine|1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
12050583|NCT00195273|Drug|corticosteroids|As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
12050584|NCT00195273|Drug|daclizumab|IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
12050585|NCT00195260|Drug|bosutinib|Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.
12050586|NCT00195260|Drug|bosutinib|400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
12050587|NCT00195260|Drug|bosutinib|400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
12050588|NCT00195260|Drug|bosutinib|400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
12050589|NCT00195247|Drug|TTI-237|
12050590|NCT00195234|Biological|HIV CTL MEP 1000 micrograms, 19 months per subject|
12050591|NCT00195208|Drug|Pantoprazole for approximately 9 weeks|
12050592|NCT00195195|Drug|Sirolimus|Transplantation patients treated with sirolimus who consent to participate in the study (register)
12050593|NCT00195182|Behavioral|Self affirmation and positive affect induction vs. control|During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
12050594|NCT00195156|Drug|ATRA-IV|
12050595|NCT00195156|Drug|Depakote|
12050596|NCT00195143|Genetic|Surgical infusion of AAV-GAD into the subthalamic nucleus|
12050597|NCT00195130|Behavioral|There are no interventions in this study|
12050598|NCT00195117|Behavioral|Intervention Group|Subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
12050599|NCT00195104|Drug|Arsenic Trioxide (Tricenox)|
12050600|NCT00195104|Drug|Cytarabine|
12050601|NCT00195091|Drug|Tetrathiomolybdate|"Induction with Tetrathiomolybdate (TM) Tetrathiomolybdate 40 mg. p.o. TID with meals and tetrathiomolybdate 60 mg at bedtime for a total of 4 doses (180 mg) per day.
~Induction goal Total tetrathiomolybdate dose per day = 180 mg until serum ceruloplasmin (Cp) level decreases to 5-15mg/dL.
~When target Cp window is reached, then the maintenance phase begins.
~Maintenance with Tetrathiomolybdate Total tetrathiomolybdate dose per day = 100 mg
~Tetrathiomolybdate 40 mg p.o. BID with meals and tetrathiomolybdate 20 mg at bedtime."
12050602|NCT00195078|Drug|ZD1839 (IRESSA)|
12050603|NCT00195078|Drug|Cisplatin|
12050604|NCT00195078|Procedure|Radiation Therapy|
12050605|NCT00195065|Behavioral|Semi-structured, open-ended interviews|
12050606|NCT00195039|Drug|177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
12050607|NCT00195026|Device|Infrared Breast Scan|Patients already scheduled for breast biopsies will receive an additional infrared scan
12050608|NCT00195013|Drug|glutamine|10 grams three times a day (orally) for four days and then stop
12050609|NCT00195013|Drug|Placebo|10 grams three times a day (orally) for four days and then stop
12050610|NCT00195000|Drug|Mylotarg|6 mg/m2 on day 1
12050611|NCT00195000|Drug|Cytarabine|100 mg/m2 given as continuous infusion daily for 7 days.
12050612|NCT00194987|Drug|IVIG (Intravenous Immunoglobulin)|one gram per kg of IVIG per infusion given either once or twice
12050613|NCT00194987|Drug|prednisone|in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
12050614|NCT00194974|Drug|methyldopa|
12050615|NCT00194974|Drug|labetalol|
12050616|NCT00194974|Drug|nifedipine|
12050617|NCT00194974|Drug|clonidine|
12050618|NCT00194961|Drug|Recombinant Human Growth Hormone|
12050619|NCT00194948|Drug|escitalopram|
12050620|NCT00194948|Behavioral|interpersonal psychotherapy|
12050621|NCT00194935|Drug|Topotecan|
12050622|NCT00194922|Dietary Supplement|E. Coli Strain M17 Probiotic|30 ml PO BID for 12 weeks
12050623|NCT00194909|Drug|sildenafil (Viagra)|
12050624|NCT00194896|Drug|rosiglitazone|Tablet taken orally at a dosage of 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Study drug was taken up to 3 years.
12050625|NCT00194896|Drug|glyburide|Tablet taken orally, initially 2.5 mg in the morning or dose subject received prior to starting the study. Dosage was increased by 2.5 mg in the evening up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Study drug was taken up to 3 years.
12050626|NCT00194883|Drug|Recombinant Human Growth Hormone|
12050627|NCT00194870|Procedure|EEG|computer-assisted analysis of the digitally-recorded EEG signals
12050628|NCT00194857|Drug|erythropoietin, GCSF|
12050629|NCT00194844|Behavioral|Nurse Caring|Nurse Caring: Couples receive three one hour counseling session with a nurse interventionist at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
12050741|NCT00193908|Drug|Sorbolene|Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
12050630|NCT00194844|Behavioral|Self Caring|Self Caring: Couples receive a mailed videotape and workbook at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
12050631|NCT00194844|Behavioral|Combined Caring|Combined Caring: Couples receive one counseling session from a nurse interventionist at approximately one week after enrollment. Upon completion of the session the nurse will hand the couple a self-caring videotape and workbook. Couples will be mailed an additional videotape and workbook at approximately 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
12050632|NCT00194818|Drug|Asacol (mesalamine)|Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks.
12050633|NCT00194805|Behavioral|Telehealth for Diabetes Self Management|
12050634|NCT00194805|Other|Telehealth for Diabetes Self Management|Web based education format delivered for a six month period
12050635|NCT00194792|Drug|exemestane|Given PO
12050636|NCT00194792|Drug|triptorelin pamoate|Given IM
12050637|NCT00194792|Drug|capecitabine|Given PO
12050638|NCT00194792|Drug|methotrexate|Given IV
12050639|NCT00194792|Drug|vinorelbine tartrate|Given IV
12050640|NCT00194792|Drug|paclitaxel|Given IV
12050641|NCT00194792|Procedure|therapeutic conventional surgery|Undergo lumpectomy or mastectomy
12050642|NCT00194792|Radiation|radiation therapy|Undergo radiation therapy
12050643|NCT00194792|Other|laboratory biomarker analysis|Correlative studies
12050644|NCT00194779|Drug|doxorubicin hydrochloride|Given IV
12050645|NCT00194779|Drug|cyclophosphamide|Given PO
12050646|NCT00194779|Drug|paclitaxel|Given IV
12050647|NCT00194779|Biological|filgrastim|Given SC
12050648|NCT00194779|Drug|capecitabine|Given PO
12050649|NCT00194779|Drug|methotrexate|Given IV
12050650|NCT00194779|Drug|vinorelbine tartrate|Given IV
12050651|NCT00194779|Procedure|needle biopsy|Correlative studies
12050652|NCT00194779|Procedure|therapeutic conventional surgery|Undergo definitive breast surgery
12050653|NCT00194779|Other|immunohistochemistry staining method|Correlative studies
12050654|NCT00194779|Biological|trastuzumab|Given IV
12050655|NCT00194779|Drug|tamoxifen citrate|Given PO
12050656|NCT00194779|Drug|letrozole|Given PO
12050657|NCT00194779|Other|laboratory biomarker analysis|Correlative studies
12050658|NCT00194766|Drug|Temozolomide|Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.
12050659|NCT00194753|Drug|Paclitaxel|80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide
12050660|NCT00194753|Drug|Doxorubicin|24 mg/m2 IV weekly x 12
12050661|NCT00194753|Drug|Cyclophosphamide|60 mg/m2 PO daily for 12 weeks
12050662|NCT00194753|Drug|G-CSF|5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks
12050663|NCT00194740|Drug|Docetaxel|60 mg/m2, IV, day 1 of each 21 day cycle
12050664|NCT00194740|Drug|Vinorelbine|27.5 mg/m2, IV, days 8 & 15 of each 21 day cycle
12050665|NCT00194740|Drug|Filgrastim|5 µg/kg/day s.c., to be administered days 2-21 of each cycle.
12050666|NCT00194727|Drug|Vinorelbine|20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
12050667|NCT00194727|Drug|Capecitabine|825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
12050668|NCT00194714|Biological|HER-2/neu Peptide Vaccine|Given ID
12050669|NCT00194714|Other|Laboratory Biomarker Analysis|Correlative studies
12050670|NCT00194701|Behavioral|Walking exercise|
12050671|NCT00194688|Drug|H. pylori treatment|
12050672|NCT00194675|Drug|Dutasteride|Dutasteride 0.5 mg orally daily
12050673|NCT00194675|Drug|Testosterone gel|Testosterone gel 7.5 g daily topical
12050674|NCT00194675|Drug|Placebo dutasteride|placebo dutasteride orally daily
12050675|NCT00194649|Drug|Miglustat (Zavesca)|100 mg Miglustat BID (twice daily) for six weeks
12050676|NCT00194636|Procedure|nerve block|
12050677|NCT00194623|Drug|Botulinum Toxin A (Botox)|
12050678|NCT00194610|Drug|Botox|Botox 25 international units per injection injected in two places in the bladder neck, with option to inject two other tender points with 25 units each
12050679|NCT00194610|Other|normal saline|Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock
12050680|NCT00194597|Drug|Viagra (sildenafil citrate)|
12050681|NCT00194584|Behavioral|7 week Building on Family Strengths Program|Parents in intervention group attend a 2 hr class for seven weeks. These classes provide information, time for discussion and creation of an action plan for the parent to complete in the intervening week.
12050682|NCT00194571|Behavioral|Educational counseling intervention|This intervention involves 5 face to face educational counseling sessions with a specially trained patient educator; sessions are fully manualized and complemented by handouts given to the diagnosed parent.
12050683|NCT00194558|Behavioral|Internet co-management module|
12050684|NCT00194545|Behavioral|Medication diaries|Caregivers expected to complete medication diaries daily
12050685|NCT00194532|Drug|Cefpodoxime|Cefpodoxime 100mg twice a day(BID)for 3 days
12050686|NCT00194532|Drug|Ciprofloxacin|Ciprofloxacin 250mg twice a day (BID)for 3 days
12050687|NCT00194519|Drug|Generic acyclovir|400 mg twice-daily oral
12050688|NCT00194519|Drug|Placebo|twice-daily oral
12050689|NCT00194506|Behavioral|Internet co-management module|
12050690|NCT00194493|Behavioral|ESRA-C|Graphical summary of patient symptoms and quality of life
12050691|NCT00194480|Drug|Pegylated Interferon|Weekly injections of pegIntereferon
12050692|NCT00194467|Drug|valganciclovir|900 mg once a day for 8 weeks
12050694|NCT00194454|Behavioral|Modified cognitive behavioral therapy plus problem-solving|9 sessions with a psychosocial nurse practitioner in which participants learn to use behavioral strategies and specific problem-solving approaches to reduce or prevent behavioral and mood disturbances characteristic of stroke.
12050695|NCT00194454|Other|usual care|Usual care with primary provider plus a booklet about mood and behavioral changes following stroke
12050696|NCT00194441|Other|Bedside display of cerebral perfusion pressure information|Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure
12050697|NCT00194428|Behavioral|Almond enriched diet|Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
12050698|NCT00194428|Behavioral|Low fat caloric diet|Low fat caloric diet
12050699|NCT00194415|Behavioral|Safer-sex counseling|Subjects will receive safer-sex counseling during pregnancy
12050700|NCT00194415|Procedure|Type specific serologic HSV testing|Subjects will be testing for HSV by Western Blot
12050701|NCT00194402|Drug|Slo-Niacin, atorvastatin|Atorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks.
12050702|NCT00194376|Procedure|Continuous positive airway pressure ventilation|CPAP ventilation is a therapeutic modality which uses positive pressure of air through a sealed nasal mask to treat a condition known as sleep apnea
12050703|NCT00194363|Behavioral|Strength training|13 weeks of supervised strength training (twice weekly for 90 minutes per session), 39 weeks of unsupervised strength training (twice weekly for 90 minutes per session)
12050704|NCT00194350|Procedure|Test for Factor V Leiden gene mutation|
12050705|NCT00194324|Drug|Miconazole nitrate|
12050706|NCT00194324|Procedure|Magnetic resonance imaging|
12050707|NCT00194324|Behavioral|Moderate levels of exercise|
12050708|NCT00194298|Procedure|FDG-PET Imaging|
12050709|NCT00194285|Procedure|FDG-PET Imaging|
12050710|NCT00194272|Drug|Methotrexate|Two dose methotrexate
12050711|NCT00194194|Behavioral|moderate|moderate behavioral management with RD
12050712|NCT00194194|Device|Resting Metablic Rate measurements|intensive behavior management
12050713|NCT00194181|Drug|TPA Infusion|
12050714|NCT00194129|Drug|Lithium|Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.
12050715|NCT00194129|Drug|Divalproex|Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.
12050716|NCT00194129|Drug|Placebo|Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
12050717|NCT00194116|Drug|Divalproex Sodium ER|Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
12050718|NCT00194116|Drug|Placebo|. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
12050719|NCT00194103|Behavioral|Telephone Monitoring and Feedback|In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.
12050720|NCT00194103|Behavioral|Telephone Monitoring and Counseling|In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.
12050721|NCT00194090|Drug|celecoxib|
12050722|NCT00194077|Drug|Aripiprazole|dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy
12050723|NCT00194077|Drug|Placebo|subjects in phase 2 will be randomized to active abilify or placebo
12050724|NCT00194064|Drug|Olanzapine|
12050725|NCT00194051|Procedure|gastric bypass surgery|
12050726|NCT00194038|Drug|Aripiprazole|Patients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment. The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated. Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible.
12050727|NCT00194025|Drug|Valproate|Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
12050728|NCT00194012|Drug|Aripiprazole|Addressed in arm description.
12050729|NCT00194012|Drug|Placebo|Addressed in arm description.
12050730|NCT00193999|Device|Placement of nasogastric tube|
12050731|NCT00193986|Device|Arbitrary Waveform Defibrillator|
12050732|NCT00193973|Drug|Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C|Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.
12050733|NCT00193973|Radiation|Radiation Therapy|Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
12050734|NCT00193960|Procedure|1) Intraocular pressure 2) visual acuity|
12050735|NCT00193921|Drug|Vinorelbine|IV, 25mg/m2, days 1, 8, 22
12050736|NCT00193921|Radiation|High dose Radiotherapy|External beam radiation, 40 Gy/20#/5 per week
12050737|NCT00193921|Drug|Gemcitabine|200mg (flat dose) IV days 1, 8, 15
12050738|NCT00193921|Drug|Cisplatin|20mg/m2, IV, weekly
12050739|NCT00193921|Radiation|High Dose Radiotherapy|External beam radiation, 30 Gy/15#/5 per week
12050740|NCT00193908|Drug|Cavilon (TM) Durable Barrier Cream|Cavilon (TM) Durable Barrier Cream will be applied to either the medial or the lateral side of the treated breast. Side will depend on randomisation.
12050742|NCT00193908|Radiation|Radiotherapy|Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
12050743|NCT00193895|Drug|Carboplatin|Carboplatin will commence with a dose calculated to target an AUC of 2.0. A maximum of 6 doses of weekly Carboplatin will be given. Carboplatin will be administered intravenously over 20-30 minutes prior to radiation therapy.
12050744|NCT00193895|Radiation|Radiotherapy|60 Gy OR 66Gy in 2Gy/fraction 5days/week
12050745|NCT00193882|Drug|Cisplatin|80mg/m2 IV day 1
12050746|NCT00193882|Radiation|Radiotherapy|35 Gy in 15 fractions
12050747|NCT00193882|Drug|5-Fluorouracil|800mg/m2/day IV days 1 - 4
12050748|NCT00193869|Drug|Dexamethasone|
12050749|NCT00193856|Drug|Leuprorelin Acetate|LH-RH analogue (LH-RHa) (Leuprorelin acetate 22.5 mg) will be delivered as a depot injection every 3 months. This will be administered as an intramuscular injection (IMI).
12050750|NCT00193856|Drug|Zoledronic Acid|Zoledronic acid 4 mg will be delivered as an intravenous infusion over 15 minutes once every 3 months for 18 months, in patients randomised to bisphosphonate therapy.
12050751|NCT00193856|Radiation|Conventional external beam therapy|The prescribed dose will be 66 Gy in 33 fractions of 2 Gy to the ICRU 50 point utilising a minimum of three fields with >= 6 MV photons.
12050752|NCT00193843|Procedure|Post-operative chemoradiotherapy / accelerated radiotherapy|
12050753|NCT00193830|Procedure|HIgh Dose Rate Vs Low DOse Rate Brachytherapy|
12050754|NCT00193817|Procedure|Two field vs Three field lymphadenectomy|
12050755|NCT00193804|Radiation|IMRT|IMRT in cervical cancers
12050756|NCT00193791|Other|CT + RT|Injection Cisplatin 40mg/m2 weekly for 5 weeks during the entire course of external radiation therapy
12050757|NCT00193778|Procedure|Surgery for breast cancer|This group will receive standard loco-regional treatment i.e. surgery (modified radical mastectomy (MRM)/ Simple SMAC/BCT) +/- radiotherapy
12050758|NCT00193778|Other|No Loco-regional treatment|This group will not receive any loco-regional treatment
12050759|NCT00193765|Procedure|Elective neck dissection in early oral cancer|Elective neck dissection in early node negative oral cancers at the time of primary surgery
12050760|NCT00193765|Procedure|Therapeutic Neck Dissection|There is no active intervention for the neck at the time of primary surgery. Therapeutic Neck Dissection at the time of nodal relapse
12050761|NCT00193752|Other|PET IMAGING|PET imaging in cervical cancers to predict, prognosticate outcome in cervical cancers
12050762|NCT00193739|Drug|NACT|3 cycles of neoadjuvant chemotherapy
12050763|NCT00193739|Procedure|Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling|NACT followed by surgery
12050764|NCT00193739|Drug|Inj.Cisplatin|Concurrent chemo radiotherapy
12050765|NCT00193739|Radiation|Concurrent chemo radiotherapy|Radiation therapy will be administered to the whole pelvis region followed by intracavitary brachytherapy.
12050766|NCT00193726|Drug|Tab Premarin (Ethinyl estradiol)|Tab Premarin 0.625 mg (Ethinyl estradiol) once a day for 5 days prior to each cycle of chemotherapy
12050767|NCT00193726|Drug|Placebo|Placebo once a day for 5 days prior to each cycle of chemotherapy
12050768|NCT00193713|Drug|bifeprunox|
12050769|NCT00193700|Drug|Testosterone Gel (1%)|
12050770|NCT00193687|Drug|bifeprunox|
12050771|NCT00193674|Drug|Dydrogesterone|20 mg/day, oral
12050772|NCT00193674|Drug|Placebo|Placebo
12050773|NCT00193661|Drug|Testosterone Gel (1%)|
12050774|NCT00193648|Drug|Rosiglitazone (Avandia)|oral drug administration
12050775|NCT00193648|Drug|Adalimumab (Humira)|Injection of drug biweekly
12050776|NCT00193635|Drug|mycophenolate mofetil|oral drug administration
12050777|NCT00193622|Drug|Bevacizumab|
12050778|NCT00193622|Drug|Erlotinib|
12050779|NCT00193609|Drug|Oxaliplatin|130 mg/m2 IV day 1 of 21 day cycle
12050780|NCT00193609|Drug|Capecitabine|1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle
12050781|NCT00193596|Drug|Etoposide|50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
12050782|NCT00193596|Drug|Gemcitabine|1000 mg/m2 IV, days 1 and 8, in regimen B
12050783|NCT00193596|Drug|Irinotecan|1000 mg/m2 IV days 1 and 8 in regimen B
12050784|NCT00193596|Drug|Paclitaxel|200 mg/m2 by 1-hour IV infusion, day 1, regimen A
12050785|NCT00193596|Drug|Carboplatin|Area under the curve (AUC) 6.0 IV, day 1, regimen A
12050786|NCT00193583|Drug|Topotecan|
12050787|NCT00193583|Drug|Carboplatin|
12050788|NCT00193570|Drug|Topotecan|
12050789|NCT00193570|Drug|Docetaxel|
12050790|NCT00193557|Drug|Bortezomib|
12050791|NCT00193544|Drug|Arsenic Trioxide|
12050792|NCT00193544|Drug|Thalidomide|
12050793|NCT00193531|Drug|Paclitaxel|
12050794|NCT00193531|Drug|Carboplatin|
12050795|NCT00193531|Drug|Etoposide|
12050796|NCT00193518|Drug|Arsenic Trioxide|
12050797|NCT00193505|Drug|Ifosfamide|
12050798|NCT00193505|Drug|Carboplatin|
12050799|NCT00193505|Drug|Etoposide|
12050800|NCT00193505|Drug|Rituximab|
12050801|NCT00193505|Drug|90Y Zevalin|
12050802|NCT00193492|Drug|Bevacizumab|
12050803|NCT00193492|Drug|Rituximab|
12050804|NCT00193479|Drug|Cyclophosphamide|Cyclophosphamide
12050805|NCT00193479|Drug|Mitoxantrone|Mitoxantrone
12050806|NCT00193479|Drug|Vincristine|Vincristine
12050807|NCT00193479|Drug|Prednisone|Prednisone
12050808|NCT00193479|Drug|Rituximab|Rituximab
12050809|NCT00193466|Drug|Rituximab|
12050810|NCT00193466|Drug|Fludarabine|
12050811|NCT00193466|Drug|CAMPTH-1H|
12050812|NCT00193453|Drug|Gemcitabine|1000mg/m2 30min IV, Day 1 & 8
12050813|NCT00193453|Drug|Docetaxel|30mg/m2, 30min IV, day 1 & 8
12050814|NCT00193453|Drug|Cetuximab|100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15
12050815|NCT00193440|Drug|Rituximab|
12050816|NCT00193440|Drug|CHOP|
12050817|NCT00193440|Drug|CVP|
12050818|NCT00193440|Drug|Ibritumomab Tiuxetan|
12050819|NCT00193427|Drug|Docetaxel|30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
12050822|NCT00193427|Radiation|Radiation|To 63 Gy
12050823|NCT00193414|Drug|Pemetrexed|500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
12050824|NCT00193414|Drug|Gemcitabine|1500mg/m2, 30min IV
12050825|NCT00193401|Drug|Topotecan|
12050826|NCT00193388|Drug|Topotecan|
12050827|NCT00193375|Drug|Irinotecan|50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
12050828|NCT00193375|Drug|Carboplatin|AUC 5
12050829|NCT00193375|Drug|Bevacizumab|10mg/kg IV every 2 weeks for 10 doses starting week 16
12050830|NCT00193375|Radiation|Radiation|
12050831|NCT00193362|Drug|Paclitaxel|
12050832|NCT00193362|Drug|Carboplatin|
12050833|NCT00193362|Drug|Gemcitabine|
12050834|NCT00193362|Drug|Vinorelbine|
12050835|NCT00193349|Drug|Imatinib|
12050836|NCT00193349|Drug|Irinotecan|
12050837|NCT00193349|Drug|Carboplatin|
12050838|NCT00193336|Drug|ZD1839|
12050839|NCT00193323|Drug|Docetaxel|
12050840|NCT00193323|Drug|Gemcitabine|
12050841|NCT00193310|Drug|Paclitaxel|
12050842|NCT00193310|Drug|Carboplatin|
12050843|NCT00193297|Drug|Topotecan|
12050844|NCT00193297|Drug|Paclitaxel|
12050845|NCT00193297|Drug|Carboplatin|
12050846|NCT00193284|Drug|Gefitinib|
12050847|NCT00193284|Drug|Docetaxel|
12050848|NCT00193284|Drug|Carboplatin|
12050849|NCT00193284|Drug|Fluorouracil|
12050850|NCT00193271|Drug|Docetaxel|
12050851|NCT00193271|Drug|Estramustine|
12050852|NCT00193258|Drug|Bevacizumab|10mg/kg IV infusion every 2 weeks
12050853|NCT00193258|Drug|Erlotinib|150 mg po daily
12050854|NCT00193258|Drug|Imatinib|400-600mg daily
12050855|NCT00193245|Drug|Topotecan|
12050856|NCT00193245|Drug|Docetaxel|
12050857|NCT00193232|Drug|Docetaxel|
12050858|NCT00193232|Drug|Bortezomib|
12050859|NCT00193219|Drug|Bevacizumab|5 mg/kg IV
12050860|NCT00193219|Drug|Cetuximab|400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8
12050861|NCT00193219|Drug|5-fluorouracil|400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)
12050862|NCT00193219|Drug|Leucovorin|350 mg IV
12050863|NCT00193219|Drug|Oxaliplatin|85 mg/m2 IV
12050864|NCT00193206|Drug|Gemcitabine|Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
12050865|NCT00193206|Drug|Epirubicin|Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
12050866|NCT00193206|Drug|Albumin-bound Paclitaxel|ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
12050867|NCT00193193|Drug|Paclitaxel|
12050868|NCT00193193|Drug|Estramustine|
12050869|NCT00193193|Drug|Carboplatin|
12050870|NCT00193180|Drug|Imatinib|Imatinib
12050871|NCT00193180|Drug|Docetaxel|Docetaxel
12050872|NCT00193167|Drug|Topotecan|
12050873|NCT00193154|Drug|OSI-774|150mg PO, days 1-28, cycle repeated every 28 days
12050874|NCT00193154|Drug|Bevacizumab|10mg/kg, IV infusion, Days 1 and 15, 28 day cycles
12050875|NCT00193141|Drug|Paclitaxel|
12050876|NCT00193141|Drug|Carboplatin|
12050877|NCT00193141|Drug|5-Fluorouracil|
12050878|NCT00193128|Drug|Oxaliplatin|40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
12050879|NCT00193128|Drug|Docetaxel|20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
12050880|NCT00193128|Drug|Capecitabine|In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
12050881|NCT00193128|Radiation|Radiation therapy|In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
12050882|NCT00193115|Drug|Docetaxel|
12050883|NCT00193115|Drug|Doxorubicin|
12050884|NCT00193115|Drug|Cyclophosphamide|
12050885|NCT00193102|Drug|Thalidomide|Thalidomide
12050886|NCT00193102|Drug|Capecitabine|Capecitabine
12050887|NCT00193089|Drug|Docetaxel|Docetaxel
12050888|NCT00193089|Drug|Vinorelbine|Vinorelbine
12050889|NCT00193089|Drug|Trastuzumab|Trastuzumab
12050890|NCT00193076|Drug|Gemcitabine|Gemcitabine
12050891|NCT00193076|Drug|Carboplatin|Carboplatin
12050892|NCT00193076|Drug|Trastuzumab|Trastuzumab
12050893|NCT00193063|Drug|Trastuzumab|Trastuzumab
12050894|NCT00193063|Drug|Gemcitabine|Gemcitabine
12050895|NCT00193050|Drug|Gemcitabine|Gemcitabine
12050896|NCT00193050|Drug|Epirubicin|Epirubicin
12050897|NCT00193050|Drug|Docetaxel|Docetaxel
12050898|NCT00193037|Drug|Liposomal Doxorubicin|Liposomal Doxorubicin
12050899|NCT00193037|Drug|Docetaxel|Docetaxel
12050900|NCT00193024|Drug|Docetaxel|
12050901|NCT00193024|Drug|Epirubicin|
12050902|NCT00193011|Drug|Docetaxel|Docetaxel
12050903|NCT00193011|Drug|Cyclophosphamide|Cyclophosphamide
12050904|NCT00193011|Drug|Methotrexate|Methotrexate
12050905|NCT00193011|Drug|5-Fluorouracil|5-Fluorouracil
12050906|NCT00192985|Device|Nitrofuranzone coated bladder catheter|
12050907|NCT00192972|Procedure|Catheter ablation (pulmonary vein isolation)|
12050908|NCT00192959|Drug|Xenon vs propofol|
12050909|NCT00192946|Procedure|Temporary cardiac resynchronization therapy|
12050910|NCT00192933|Procedure|NovoSeven treatment according to guideline|
12050911|NCT00192920|Behavioral|Transfusion practice|
12050912|NCT00192881|Device|Bx Sonic & Cypher stent from Cordis|
12050913|NCT00192868|Procedure|Distal protection and drug eluting stent|
12050914|NCT00192855|Drug|Entacapone|Entacapone 600mg BID
12050915|NCT00192842|Drug|curcumin (+ gemcitabine)|
12050916|NCT00192829|Procedure|Blood sample withdrawal|
12050917|NCT00192816|Behavioral|reaction to pain|
12050918|NCT00192803|Drug|candesartan|
12050919|NCT00192777|Drug|Xeloda|
12050920|NCT00192777|Procedure|External Beam Radiotherapy|
12050921|NCT00192764|Drug|high-dose cyclophosphamide|
12050922|NCT00192751|Behavioral|Psychoeducational group sessions|
12050923|NCT00192725|Other|rapid tryptophan depletion|Amino-acid mixture without tryptophan
12050924|NCT00192712|Drug|irinotecan, gemcitabine|
12050925|NCT00192699|Device|Bimetric femoral stem|Cemented Bi-Metric femoral stem
12050926|NCT00192686|Procedure|culture a.m. Kamme-Lindberg|
12050927|NCT00192673|Drug|PEG-asparaginase|
12050928|NCT00192660|Drug|Lamivudine|
12050929|NCT00192660|Drug|Stavudine|
12050930|NCT00192660|Drug|Didanosine|
12050931|NCT00192660|Drug|Zidovudine|
12050932|NCT00192660|Drug|Tenofovir|
12050933|NCT00192660|Drug|Abacavir|
12050934|NCT00192660|Drug|Efavirenz (EFV)|
12050935|NCT00192660|Drug|Nevirapine|
12050936|NCT00192660|Drug|Indinavir|
12050937|NCT00192660|Drug|Saquinavir|
12050938|NCT00192660|Drug|Amprenavir|
12050939|NCT00192660|Drug|Ritonavir|
12050940|NCT00192660|Drug|Nelfinavir|
12050941|NCT00192660|Drug|Tipranavir|
12050942|NCT00192660|Drug|enfuvirtide (T20)|
12050943|NCT00192647|Drug|PEG-IFN alfa-2a|PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
12050944|NCT00192647|Drug|Ribavirin|Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
12050945|NCT00192634|Drug|Emtricitabine 200mg - Tenofovir 300mg|1 tablet once daily for 96 weeks
12050946|NCT00192634|Drug|Abacavir 600mg - Lamivudine 300mg|1 tablet once daily for 96 weeks
12050947|NCT00192621|Drug|Combivir (zidovudine [AZT] / lamivudine [3TC])|
12050948|NCT00192621|Drug|Kaletra (lopinavir [LPVr])|
12050949|NCT00192608|Drug|saquinavir 500 formulation|NRTIs + SQV/RTV 1000/100 mg BID using 200 mg SQV capsules switched at entry to ATV/SQV/RTV 300/1500/100 mg QD using 500 mg SQV tablet for 48 weeks with PK at days 0 and 8.
12050950|NCT00192608|Drug|cross-over arm|either ATV/SQV/RTV 300/1500/100 QD (500 mg SQV tabs) for 7 days then after PK SQV changed to 1600 mg QD (200 mg caps) with PK day 15, or ATV/SQV/RTV 300/1600/100 QD for 7 days with switch to SQV 1500 mg QD. After day 15 PK both groups switch to ATV/SQV/RTV 300/1500/100 QD to week 48
12050951|NCT00192595|Drug|Tenofovir|
12050952|NCT00192595|Drug|Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)|
12050953|NCT00192582|Behavioral|Motivational Interview with care plan and education|
12050954|NCT00192569|Drug|Pegylated Interferon alfa 2a|PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
12050955|NCT00192569|Drug|Ribavirin (HIV conifected patients only)|"genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg)
~Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients"
12050956|NCT00192556|Behavioral|food|
12050957|NCT00192543|Behavioral|diet of fish and fruit|fish and fruit in specified quantities
12050958|NCT00192543|Behavioral|fruit and fish|no drugs
12050959|NCT00192543|Behavioral|diet only|Fish and fruit
12050960|NCT00192543|Behavioral|regular diet|no change in regular diet
12050961|NCT00192517|Drug|MEDI-522|4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
12050962|NCT00192517|Other|Placebo|4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
12050963|NCT00192504|Biological|MEDI-524|
12050964|NCT00192491|Biological|FluMist|Nasal Sprayer of one dosage of FluMist and other experimental
12050965|NCT00192491|Biological|FluMist|Nasal sprayer of FluMist
12050966|NCT00192491|Other|Placebo|Nasal Sprayer of Placebo
12050967|NCT00192478|Biological|Medi-524|IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals
12050968|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp.1: 3 mg/kg IV (single dose)
12050969|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp. 2: 15 mg/kg IV (single dose)
12050970|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp. 3: 30 mg/kg IV (single dose)
12050971|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp. 4: 3 mg/kg IM (single dose)
12050972|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp.5: 3 mg/kg IM (two doses)
12050973|NCT00192452|Drug|MEDI-507|
12050974|NCT00192439|Behavioral|High Risk Respiratory Disease|
12050975|NCT00192426|Biological|CAIV-T|
12050976|NCT00192413|Biological|Cold-adapted influenza vaccine trivalent (CAIV-T)|Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.
12050977|NCT00192413|Biological|Trivalent Inactivated Vaccine (TIV)|Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).
12050978|NCT00192400|Biological|CAIV-T|
12050979|NCT00192387|Biological|CAIV-T, Liquid|
12050980|NCT00192374|Biological|CAIV-T, Liquid|
12050981|NCT00192361|Biological|CAIV-T|
12050982|NCT00192348|Biological|CAIV-T|
12050983|NCT00192335|Biological|CAIV-T|
12050984|NCT00192335|Biological|CAIVT|The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
12050985|NCT00192335|Biological|FluMist|The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
12050986|NCT00192322|Biological|CAIV-T 10^7|a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
12050987|NCT00192322|Biological|CAIVT 10^5|a single intranasal 0.2 mL dose of CAIV-T <10^5
12050988|NCT00192322|Biological|Placebo|a single intranasal 0.2 mL dose of placebo
12050989|NCT00192322|Biological|TIV|commercially available TIV injected intramuscularly
12051047|NCT00191854|Drug|gemcitabine|2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
12051048|NCT00191854|Drug|paclitaxel|150 mg/m2, IV, every 14 days x 8 cycles
12051049|NCT00191854|Drug|carboplatin|Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles
12050990|NCT00192309|Biological|CAIV-T|Liquid CAIV-T vaccine for this study consisted of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) and B/Yamanashi/166/98 influenza virus strains. The reassortant vaccine strains were grown in specific pathogen-free (SPF) eggs and the allantoic fluid, which contained virus, was harvested, concentrated and purified. Each dose of CAIV-T used in this study was formulated to contain approximately 107 FFU of each of the 6:2 influenza reassortant vaccine strains.
12050991|NCT00192309|Biological|TIV|TIV in this study consisted of Flushield™, manufactured by Wyeth Vaccines, Marietta, PA, USA. Each 0.5 mL dose contained no less than 15 ug of the hemagglutinin antigens from each of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Yamanashi/166/98 strains, making TIV in this study antigenically matched to the influenza strains contained in CAIV-T.
12050992|NCT00192309|Biological|Placebo|Placebo in this study consisted of physiological saline. The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
12050993|NCT00192296|Biological|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
12050994|NCT00192296|Biological|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
12050995|NCT00192296|Biological|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
12050996|NCT00192296|Biological|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
12050997|NCT00192283|Biological|CAIV-T|The total single-dose volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
12050998|NCT00192283|Other|Placebo|A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
12050999|NCT00192270|Biological|CAIV-T|Each dose of the vaccine was formulated to contain approximately 1 x 10^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of ~3 x 10^7 TCID50 per dose.
12051000|NCT00192257|Biological|CAIV-T and TIV|
12051001|NCT00192244|Biological|CAIV-T, Liquid|
12051002|NCT00192231|Biological|CAIV-T|
12051003|NCT00192218|Biological|FluMist|0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type
12051004|NCT00192205|Biological|CAIV-T or TIV|
12051005|NCT00192192|Biological|CAIV-T|
12051006|NCT00192179|Biological|Cold-adapted influenza vaccine trivalent (CAIV-T)|The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.
12051007|NCT00192179|Biological|Placebo|The placebo consisted of physiologic normal saline.
12051008|NCT00192166|Biological|CAIV-T|
12051009|NCT00192153|Biological|CAIV-T or TIV|
12051010|NCT00192140|Biological|FluMist|A single intranasal dose of FluMist will be administered to approx. 300 subjects.
12051011|NCT00192127|Biological|FluMist|A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.
12051012|NCT00192127|Other|Placebo|A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0
12051013|NCT00192114|Drug|Enzastaurin HCl|1200 milligrams (mg) loading dose orally, then 500 mg, orally, daily, up to six 28-day cycles.
12051014|NCT00192101|Drug|gemcitabine|
12051015|NCT00192101|Drug|cisplatin|
12051016|NCT00192088|Drug|pemetrexed|
12051017|NCT00192088|Drug|oxaliplatin|
12051018|NCT00192075|Drug|Gemcitabine|900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression.
12051019|NCT00192075|Drug|avastin|5 milligrams per kilogram (mg/kg)
12051020|NCT00192075|Drug|5FU/folinic acid|"Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG).
~Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).
~5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4)."
12051021|NCT00192075|Drug|oxaliplatin|85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.
12051022|NCT00192062|Drug|gemcitabine|
12051023|NCT00192062|Drug|vinorelbine|
12051024|NCT00192049|Drug|Gemcitabine|
12051025|NCT00192049|Drug|mitomycin C|
12051026|NCT00192036|Drug|gemcitabine|1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5)
12051027|NCT00192036|Drug|cisplatin|80 mg/m2, IV, every 21 days x 5 cycles
12051028|NCT00192036|Radiation|radiation|63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
12051029|NCT00192023|Drug|atomoxetine 0.5 mg/kg/day|atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)
12051030|NCT00192023|Drug|placebo|
12051031|NCT00192023|Drug|atomoxetine 1.2 mg/kg/day|atomoxetine 1.2 mg/kg/day QD, PO
12051032|NCT00192023|Drug|atomoxetine 1.2-1.4 mg/kg/day|atomoxetine 1.2 - 1.4 mg/kg/day QD, PO
12051033|NCT00191997|Drug|Olanzapine|
12051034|NCT00191984|Drug|pemetrexed|400 mg/m^2, intravenous (IV), every 14 days x 12 cycles
12051035|NCT00191984|Drug|irinotecan|180 mg/m^2, intravenous (IV), every 14 days x 12 cycles
12051036|NCT00191971|Drug|Gemcitabine|
12051037|NCT00191945|Drug|Atomoxetine Hydrochloride|
12051038|NCT00191945|Drug|placebo|
12051039|NCT00191932|Drug|Duloxetine|
12051040|NCT00191919|Drug|Duloxetine Hydrochloride|
12051041|NCT00191919|Drug|Placebo|
12051042|NCT00191906|Drug|Atomoxetine Hydrochloride|Atomoxetine, 1.2 mg/kg/day, by mouth (PO)
12051043|NCT00191906|Drug|placebo|Placebo, every day (QD), by mouth (PO)
12051044|NCT00191893|Drug|teriparatide|
12051045|NCT00191880|Drug|atomoxetine|
12051046|NCT00191867|Drug|Teriparatide|
12051128|NCT00191321|Drug|Teriparatide|
12051050|NCT00191854|Drug|cisplatin|50 mg/m2, IV, every 14 days x 8 cycles
12051051|NCT00191841|Drug|gemcitabine|
12051052|NCT00191841|Drug|Cisplatin|
12051053|NCT00191828|Drug|olanzapine|
12051054|NCT00191815|Drug|Gemcitabine|Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
12051055|NCT00191815|Drug|cisplatin|Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
12051056|NCT00191802|Drug|teriparatide|
12051057|NCT00191789|Drug|gemcitabine|1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)
12051058|NCT00191789|Drug|doxorubicin|60 mg/m^2, IV, every 21 days x 4 cycles (1-4)
12051059|NCT00191789|Drug|cisplatin|70 mg/m^2, IV, every 21 days x 4 cycles (5-8)
12051060|NCT00191789|Procedure|surgery|Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
12051061|NCT00191763|Drug|Gemcitabine|
12051062|NCT00191763|Drug|cisplatin|
12051063|NCT00191750|Drug|Pemetrexed|
12051064|NCT00191737|Drug|Atomoxetine|
12051065|NCT00191724|Drug|Drotrecogin Alfa (Activated)|6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
12051066|NCT00191724|Drug|Enoxaparin|1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
12051067|NCT00191724|Drug|Placebo|intravenous (IV), one infusion, over 12 hours
12051068|NCT00191724|Drug|Drotrecogin Alfa (Activated)|12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
12051069|NCT00191724|Drug|Drotrecogin Alfa (Activated)|18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
12051070|NCT00191724|Drug|Drotrecogin Alfa (Activated)|24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
12051071|NCT00191711|Drug|Gemcitabine|
12051072|NCT00191698|Drug|atomoxetine hydrochloride|
12051073|NCT00191698|Drug|placebo|
12051074|NCT00191685|Drug|duloxetine|
12051075|NCT00191672|Drug|Gemcitabine|
12051076|NCT00191672|Drug|Paclitaxel|
12051077|NCT00191672|Drug|Docetaxel|
12051078|NCT00191659|Drug|Atomoxetine Hydrochloride|
12051079|NCT00191646|Drug|Gemcitabine|"1000 mg/m^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles
~If anything other than complete response in Paclitaxel arm patients, 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity"
12051080|NCT00191646|Drug|Paclitaxel|"175 mg/m^2, IV, Day 1, q 21 days x 6 cycles
~If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m^2, IV, 3 hours q 28 days x 12 cycles (1 year)
~If no complete response, then Gemcitabine arm patients may receive 175 mg/m^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity"
12051081|NCT00191646|Drug|Carboplatin|"Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles
~Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles"
12051082|NCT00191633|Drug|Atomoxetine|
12051083|NCT00191620|Drug|Gemcitabine|
12051084|NCT00191620|Drug|cisplatin|
12051085|NCT00191607|Drug|Gemcitabine|
12051086|NCT00191607|Drug|liposomal doxorubicin|
12051087|NCT00191594|Drug|Duloxetine Hydrochloride|
12051088|NCT00191581|Drug|Humalog Mix 50|
12051089|NCT00191581|Drug|Human Insulin Mix 50:50|
12051090|NCT00191568|Drug|Gemcitabine|
12051091|NCT00191568|Drug|Oxaliplatin|
12051092|NCT00191568|Procedure|Radiotherapy|
12051093|NCT00191555|Drug|olanzapine|
12051094|NCT00191555|Drug|haloperidol|
12051095|NCT00191542|Drug|Atomoxetine|
12051096|NCT00191542|Drug|Placebo|
12051097|NCT00191529|Drug|somatropin|
12051098|NCT00191516|Drug|Atomoxetine|
12051099|NCT00191503|Drug|Pemetrexed|
12051100|NCT00191503|Drug|Gemcitabine|
12051101|NCT00191490|Drug|Gemcitabine|
12051102|NCT00191490|Drug|docetaxel|
12051103|NCT00191490|Drug|cisplatin|
12051104|NCT00191477|Drug|Gemcitabine|2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
12051105|NCT00191477|Drug|Placebo|intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
12051106|NCT00191464|Drug|premeal insulin lispro mixtures|
12051107|NCT00191464|Drug|insulin glargine|
12051108|NCT00191464|Drug|metformin|
12051109|NCT00191451|Drug|Gemcitabine|Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
12051110|NCT00191451|Drug|Carboplatin|Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
12051111|NCT00191451|Drug|Herceptin|"Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion).
~Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
12051112|NCT00191438|Drug|gemcitabine|
12051113|NCT00191438|Drug|capecitabine|
12051114|NCT00191438|Drug|docetaxel|
12051115|NCT00191425|Drug|Teriparatide|
12051116|NCT00191425|Drug|Raloxifene|
12051117|NCT00191412|Drug|Pemetrexed|
12051118|NCT00191399|Drug|Olanzapine|
12051119|NCT00191399|Drug|Fluoxetine|
12051120|NCT00191386|Drug|Atomoxetine hydrochloride|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
12051121|NCT00191373|Drug|Gemcitabine|
12051122|NCT00191373|Drug|Trastuzumab|
12051123|NCT00191360|Drug|Somatropin|
12051124|NCT00191347|Drug|pemetrexed|
12051125|NCT00191347|Drug|gemcitabine|
12051126|NCT00191334|Drug|gemcitabine|1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity
12051127|NCT00191334|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
12051129|NCT00191308|Drug|pemetrexed|500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
12051130|NCT00191308|Drug|cisplatin|75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
12051131|NCT00191308|Procedure|Radical Non-Small Cell Lung Cancer (NSCLC) surgery|All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.
12051132|NCT00191295|Drug|Atomoxetine|
12051133|NCT00191295|Drug|Placebo|
12051134|NCT00191282|Drug|Insulin lispro|Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study
12051135|NCT00191282|Drug|Human insulin isophane suspension (NPH)|Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%
12051136|NCT00191282|Drug|Insulin glargine|Insulin glargine injected subcutaneous (SC) once daily in the evening until patient completes study.
12051137|NCT00191282|Drug|Human insulin isophane suspension|Patient adjusted dose, twice daily, injected subcutaneous (SC) before morning and evening meals until patient completes study.
12051138|NCT00191282|Drug|Human insulin 30/70|Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
12051139|NCT00191269|Drug|gemcitabine|1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
12051140|NCT00191269|Drug|gemcitabine|1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
12051141|NCT00191256|Drug|Gemcitabine|
12051142|NCT00191256|Drug|Carboplatin|
12051143|NCT00191256|Drug|Paclitaxel|
12051144|NCT00191243|Drug|Gemcitabine|"A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression
~B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure"
12051145|NCT00191243|Drug|docetaxel|"A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine
~B: 80 mg/m2, IV, q 21 days until treatment failure"
12051146|NCT00191230|Drug|gemcitabine|
12051147|NCT00191230|Drug|carboplatin|
12051148|NCT00191230|Drug|cisplatin|
12051149|NCT00191204|Drug|Duloxetine|
12051150|NCT00191191|Drug|Pemetrexed 500 mg/m2|500 mg/m2, intravenous (IV), every 21 days, one year from registration date
12051151|NCT00191191|Drug|Pemetrexed 1000 mg/m2|1000 mg/m2, intravenous (IV), every 21 days, one year from registration date
12051152|NCT00191178|Drug|insulin lispro protamine suspension:insulin lispro rDNA origin low mix|
12051153|NCT00191178|Drug|insulin glargine|
12051154|NCT00191165|Drug|Somatropin|Doubled dosage with respect to the pre-enrollment (in-label) dosage
12051155|NCT00191165|Drug|Somatropin|In-label dosage
12051156|NCT00191152|Drug|gemcitabine|1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
12051157|NCT00191152|Drug|docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression
12051158|NCT00191152|Drug|capecitabine|1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression
12051159|NCT00191139|Drug|gemcitabine|After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.
12051160|NCT00191139|Drug|docetaxel|Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
12051161|NCT00191139|Drug|cisplatin|As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)
12051162|NCT00191139|Drug|etoposide|As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)
12051163|NCT00191139|Radiation|radiation therapy|In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks
12051164|NCT00191126|Drug|gemcitabine|1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles
12051165|NCT00191126|Drug|Cisplatin|75 mg/m2, IV, q 21 days x 3 cycles
12051166|NCT00191126|Procedure|surgery|surgery
12051167|NCT00191113|Drug|Somatropin|0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).
12051168|NCT00191113|Drug|Ethinyl estradiol|escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.
12051169|NCT00191113|Drug|Medroxyprogesterone acetate|10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.
12051170|NCT00191100|Drug|Gemcitabine|
12051171|NCT00191100|Drug|Cisplatin|
12051172|NCT00191100|Radiation|Brachytherapy|Brachytherapy, 30-35 Gy over 1 week
12051173|NCT00191100|Radiation|Pelvic radiation|Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
12051174|NCT00191087|Drug|Duloxetine|
12051175|NCT00191074|Drug|somatropin, rDNA origin, for injection|
12051176|NCT00191061|Drug|duloxetine hydrochloride|
12051177|NCT00191048|Drug|Atomoxetine|
12051178|NCT00191035|Drug|Atomoxetine|
12051179|NCT00191022|Drug|LY686017|
12051180|NCT00191022|Drug|paroxetine|
12051181|NCT00191022|Drug|placebo|
12051182|NCT00191009|Drug|atomoxetine hydrochloride|
12051183|NCT00191009|Drug|placebo|
12051184|NCT00190996|Drug|Duloxetine Hydrochloride|
12051185|NCT00190996|Drug|placebo|
12051186|NCT00190983|Drug|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.
12051187|NCT00190970|Drug|Ruboxistaurin|
12051188|NCT00190957|Drug|Atomoxetine|
12051189|NCT00190957|Drug|placebo|
12051190|NCT00190944|Drug|Teriparatide|
12051191|NCT00190944|Drug|placebo|
12051192|NCT00190931|Drug|Atomoxetine Hydrochloride|
12051193|NCT00190931|Drug|placebo|
12051194|NCT00190918|Drug|Pemetrexed|
12051198|NCT00190879|Drug|Atomoxetine hydrochloride|
12051199|NCT00190879|Drug|placebo|
12051200|NCT00190866|Drug|Duloxetine|
12051201|NCT00190866|Drug|placebo|
12051202|NCT00190853|Drug|Duloxetine|
12051203|NCT00190840|Drug|pemetrexed|
12051204|NCT00190827|Drug|duloxetine|
12051205|NCT00190827|Drug|placebo|
12051206|NCT00190814|Drug|duloxetine|
12051207|NCT00190814|Drug|placebo|
12051208|NCT00190801|Drug|pemetrexed|
12051209|NCT00190801|Drug|cisplatin|
12051210|NCT00190788|Drug|Drotrecogin Alfa (Activated)|
12051211|NCT00190788|Drug|placebo|
12051212|NCT00190775|Drug|Atomoxetine Hydrochloride|Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
12051213|NCT00190775|Drug|Placebo|Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.
12051214|NCT00190762|Drug|Pemetrexed|
12051215|NCT00190749|Drug|olanzapine|5-20 mg, oral, capsules, daily, 12 weeks.
12051216|NCT00190749|Drug|risperidone|2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
12051217|NCT00190736|Drug|Atomoxetine Hydrochloride|
12051218|NCT00190736|Drug|placebo|
12051219|NCT00190723|Drug|Enzastaurin|
12051220|NCT00190710|Drug|Gemcitabine|
12051221|NCT00190710|Drug|Carboplatin|
12051222|NCT00190697|Drug|arzoxifene|
12051223|NCT00190684|Drug|atomoxetine|0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
12051224|NCT00190671|Drug|pemetrexed|Pemetrexed: 600 mg/m2, intravenous (IV), every 21 days x 8 cycles
12051225|NCT00190671|Drug|cyclophosphamide|600 mg/m2, intravenous (IV), every 21 days x 8 cycles
12051226|NCT00190671|Drug|pemetrexed|1800 mg/m2, intravenous (IV), every 21 days x 8 cycles
12051227|NCT00190658|Drug|Somatropin (rDNA origin) for injection|
12051228|NCT00190645|Drug|Duloxetine|
12051229|NCT00190632|Drug|Duloxetine|
12051230|NCT00190619|Drug|Duloxetine|
12051231|NCT00190619|Drug|Placebo|
12051232|NCT00190606|Drug|Duloxetine|
12051233|NCT00190606|Procedure|Pelvic Floor Muscle Training (PFMT)|
12051234|NCT00190606|Procedure|Imitation PFMT|
12051235|NCT00190606|Drug|placebo|
12051236|NCT00190593|Drug|raloxifene|
12051237|NCT00190593|Drug|placebo|
12051238|NCT00190580|Drug|valsartan|valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
12051239|NCT00190580|Drug|Conventional antihypertensive drugs|Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
12051240|NCT00190567|Drug|duloxetine|
12051241|NCT00190567|Drug|Placebo|
12051242|NCT00190554|Drug|Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2|
12051243|NCT00190554|Drug|(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery|
12051244|NCT00190541|Procedure|Mesorectal excision with lateral lymph node dissection|Mesorectal excision with lateral lymph node dissection
12051245|NCT00190541|Procedure|Mesorectal excision without lateral lymph node excision|Mesorectal excision without lateral lymph node excision
12051246|NCT00190528|Drug|neoadjuvant chemotherapy + radical hysterectomy|
12051247|NCT00190528|Procedure|radical hysterectomy|
12051248|NCT00190515|Drug|5FU+l-leucovorin|5FU+l-leucovorin
12051249|NCT00190515|Drug|UFT+Leucovorin|UFT+Leucovorin
12051250|NCT00190502|Drug|Polyclonal anti-T-cell antibodies|
12051251|NCT00190489|Drug|AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles|
12051252|NCT00190489|Drug|Docetaxel 60mg/m2 every 21 days for 6 cycles|
12051253|NCT00190489|Drug|AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles|
12051254|NCT00190476|Drug|Weekly docetaxel alone|
12051255|NCT00190476|Drug|Weekly docetaxel + cisplatin combination|
12051256|NCT00190463|Drug|Amphotericin B|
12051257|NCT00190450|Biological|graft intracerebral of foetal neurons|graft intracerebral of foetal neurons
12051258|NCT00190437|Drug|Amoxicillin-clavulanic|Amoxicillin-clavulanic
12051259|NCT00190424|Drug|CpG-ODN|
12051260|NCT00190411|Drug|celiprolol|celiprolol
12051261|NCT00190411|Drug|Control|Untreated controls excluding betablockers
12051262|NCT00190398|Device|Carotid angioplasty and stenting with cerebral protection|Carotid angioplasty and stenting with cerebral protection
12051263|NCT00190385|Procedure|Ultrasonographic screening|Ultrasonographic screening
12051264|NCT00190372|Behavioral|Controlled diet|Controlled diet
12051265|NCT00190372|Behavioral|Self-hypnotic relaxation|Self-hypnotic relaxation
12051266|NCT00190346|Device|Humidification devices: HH vs HME|
12051267|NCT00190333|Drug|escitalopram|escitalopram
12051268|NCT00190320|Procedure|Induction of labor vs waiting|
12051269|NCT00190307|Drug|aspirin 75 mg/day|aspirin 75 mg/day
12051270|NCT00190294|Drug|MIFEPRISTONE 200 mg and misoprostol 400 µg|MIFEPRISTONE 200 mg and misoprostol 400 µg
12051271|NCT00190268|Drug|3,4-diaminopyridine|3,4-diaminopyridine
12051272|NCT00190255|Procedure|CY2PC9 genotyping|CY2PC9 genotyping
12051273|NCT00190242|Drug|group1|Havrix at 1440IU was administrated à weeks S0, S4 and S24
12051274|NCT00190242|Drug|group2|Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS
12051275|NCT00190229|Drug|Cyclophosphamide|Cyclophosphamide
12051276|NCT00190216|Device|Magnetic stimulator|
12051277|NCT00190203|Procedure|Decompressive hemicraniectomy and duraplasty|Decompressive hemicraniectomy and duraplasty
12051278|NCT00190203|Procedure|hemicraniectomy|hemicraniectomy
12051279|NCT00190190|Procedure|With Peeling of Limiting the Intern of the Retina|With Peeling of Limiting the Intern of the Retina
12051280|NCT00190190|Procedure|Internal limiting membrane peeling|Traditional Procedure Without Peeling of Limiting
12051281|NCT00190164|Procedure|Macular hole surgery with alleviated positioning|Macular hole surgery with alleviated positioning
12051282|NCT00190164|Procedure|Macular hole surgery with no alleviated positioning|Macular hole surgery with no alleviated positioning
12051283|NCT00190151|Drug|ciprofloxacin|
12051284|NCT00190138|Device|Bi-ventricular pacing|
12051285|NCT00190112|Procedure|ventral cardiac denervation|
12051286|NCT00190099|Device|Dexamethasone-Eluting Stent|
12051287|NCT00190060|Drug|Transdermal testosterone gel (Testogel 1% )|Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
12051288|NCT00190060|Drug|Matched transdermal placebo gel|Matched transdermal placebo gel, 50mg/d for 6 months
12051289|NCT00190047|Drug|DP-b99|
12051290|NCT00190034|Drug|N-Acetylcysteine 600mg/tab|
12051291|NCT00190021|Drug|donepezil|
12051292|NCT00190008|Drug|piracetam|
12051293|NCT00189995|Drug|clozapine|
12051294|NCT00189995|Drug|haloperidol|
12051295|NCT00189982|Drug|Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)|"Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator). Once the treatment regimen was established, the regimen was to be maintained for the duration of the study, unless clinical reasons necessitated a change.
~The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care."
12051296|NCT00189969|Biological|Elstree-BN|
12051297|NCT00189956|Biological|IMVAMUNE (MVA-BN)|Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
12051298|NCT00189943|Biological|MVA-BN|
12051299|NCT00189930|Biological|MVA-nef|3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm
12051300|NCT00189930|Biological|IMVAMUNE|3 immunizations: 1E8_TCID50 IMVAMUNE
12051301|NCT00189917|Biological|IMVAMUNE (MVA-BN)|1x10E08 TCID50, subcutaneous vaccination
12051302|NCT00189904|Biological|IMVAMUNE (MVA-BN)|
12051303|NCT00189878|Drug|Methotrexate (drug)|Methotrexate 10 to 15 mg weekly for 8 weeks
12051304|NCT00189878|Drug|placebo capsules|4-6 placebo capsules - identical to capsules containing methotrexate
12051305|NCT00189852|Device|Chronic heart failure monitoring system|
12051306|NCT00189852|Device|Lifestyle monitoring system|
12051307|NCT00189839|Drug|tacrolimus|Immunosuppression
12051308|NCT00189826|Drug|tacrolimus|immunosuppression
12051309|NCT00189813|Drug|YM060|
12051310|NCT00189800|Drug|Solifenacin succinate|
12051311|NCT00189787|Drug|tacrolimus|
12051312|NCT00189774|Drug|nateglinide|
12051313|NCT00189761|Drug|Tacrolimus|
12051314|NCT00189748|Drug|Tacrolimus|
12051315|NCT00189735|Drug|FK778|
12051316|NCT00189722|Drug|Tacrolimus|
12051317|NCT00189709|Drug|Micafungin|IV
12051318|NCT00189709|Drug|fluconazole|IV
12051319|NCT00189696|Drug|YM060|
12051320|NCT00189683|Procedure|Monitoring|
12051321|NCT00189683|Procedure|Xeloda|
12051322|NCT00189670|Procedure|6 TEC q 3 weeks|
12051323|NCT00189670|Procedure|4 EC q 2 weeks followed by 4 TXT q 2 weeks|
12051324|NCT00189670|Procedure|4 TXT q 2 weeks followed by 4 EC q 2 weeks|
12051325|NCT00189657|Procedure|5FU/LV Mayo Clinic or LV5FU2|
12051326|NCT00189657|Procedure|LV5FU2 + irinotecan|
12051327|NCT00189644|Procedure|6 FEC 100|
12051328|NCT00189644|Procedure|4 FEC 100 followed by 4 Taxol|
12051329|NCT00189631|Procedure|UFT/LV|
12051330|NCT00189631|Procedure|Observation|
12051331|NCT00189618|Drug|Aspirin|100mg p.o. OD
12051332|NCT00189618|Drug|Clopidogrel|75mg p.o. OD
12051333|NCT00189605|Device|Perc-DLR/Perc-DLG|Device technique will be used per IFU
12051334|NCT00189605|Drug|Fluoroscopy guided transforaminal epidural steroid injection (TFESI)|Injection of steroid solution into the lumbar level
12051335|NCT00189592|Device|ArthroCare TOPAZ™ MicroDebrider™ using Coblation|Percutaneous treatment of plantar fascia using the Topaz device. No incision performed.
12051336|NCT00189592|Procedure|Surgical Fasciotomy|Standard surgical fasciotomy using an incision to treat the plantar fascia.
12051337|NCT00189579|Drug|Herceptin|
12051338|NCT00189566|Drug|Paclitaxel|
12051339|NCT00189566|Drug|Topotecan|
12051340|NCT00189566|Drug|Carboplatin|
12051341|NCT00189553|Drug|Pegylated liposomal doxorubicin|30 mg/m² every 4 weeks during 6 cycles or until progression
12051342|NCT00189553|Drug|Carboplatin|AUC 5 every 3/4 weeks during 6 cycles or until progression
12051343|NCT00189553|Drug|Paclitaxel|175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression
12051344|NCT00189540|Genetic|HGF plasmid|Intramuscular injections into the index leg on days 0, 14, and 28
12051345|NCT00189540|Genetic|Placebo|Intramuscular injections into the index leg on days 0, 14, and 28
12051346|NCT00189527|Procedure|respiratory settings|
12051347|NCT00189514|Drug|pramlintide acetate|Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
12051348|NCT00189514|Drug|placebo|subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate
12051349|NCT00189501|Drug|Sensipar®|
12051350|NCT00189488|Drug|Palifermin|Administered as an intravenous (IV) bolus.
12051351|NCT00189488|Drug|Placebo|Administered as an intravenous (IV) bolus.
12051352|NCT00189488|Other|Conditioning Regimen|"Each participant received 1 of the following conditioning regimens:
~Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16)
~TBI/VP-16
~Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie > 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible)
~Busulfan (Bu)/Cy
~Bu/Mel (non-TBI but fully ablative regimens/doses [Mel dose > 140 mg/m^2])
~Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses [Mel dose > 140 mg/m^2])"
12051353|NCT00189488|Procedure|Allogeneic stem cell transplant|Allogeneic marrow/peripheral blood progenitor cell transplantation
12051354|NCT00189488|Drug|Methotrexate|
12051355|NCT00189475|Drug|Montelukast|
12051356|NCT00189475|Drug|Placebo|
12051357|NCT00189462|Drug|Montelukast|
12051359|NCT00189436|Drug|Nebulized Budesonide|Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
12051360|NCT00189436|Drug|Usual care (albuterol with or without oral steroid)|Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
12051361|NCT00189423|Device|Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)|"The ITD selectively prevents the influx of unnecessary respiratory gases into the patient during the chest wall recoil phase of CPR.
~The ResQPump, a hand-held device containing a suction cup, attaches to the chest and actively compresses and actively re-expands the chest during the performance of CPR."
12051362|NCT00189423|Procedure|Standard cardiopulmonary resuscitation (S-CPR)|Conventional standard cardiopulmonary resuscitation (S-CPR)
12051363|NCT00189410|Drug|Pegylated Liposomal Doxorubicin and Carboplatin|
12051364|NCT00189397|Drug|azathioprine and corticosteroids for Parthenium dermatitis|
12051365|NCT00189384|Drug|ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin|
12051366|NCT00189371|Drug|paclitaxel, carboplatin, epoetin alpha|
12051367|NCT00189358|Drug|ZD1839|
12051368|NCT00189358|Drug|tamoxifen|
12051369|NCT00189345|Biological|anti-EpCAM x anti-CD3 (removab)|
12051370|NCT00189332|Drug|852A|
12051371|NCT00189319|Drug|Flecainide controlled release|
12051372|NCT00189306|Drug|Imiquimod 5% cream|Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
12051373|NCT00189293|Drug|Imiquimod|"Imiquimod 5% cream three times per week for 4 weeks (1 sachet)
~1 or 2 sachet(s)"
12051374|NCT00189293|Other|vehicle cream|"vehicle cream three times per week for 4 weeks (1 sachet)
~1 or 2 sachet(s)"
12051375|NCT00189280|Drug|Imiquimod|cream 5%, 5 days out of seven, for 6 weeks
12051376|NCT00189267|Drug|Imiquimod 5 % Cream|
12051377|NCT00189254|Drug|Imiquimod|No defined treatments were given during this study.
12051378|NCT00189241|Drug|imiquimod|
12051379|NCT00189228|Drug|Xolair|Patients are administered Xolair
12051380|NCT00189215|Device|cardiac stabilizer instead of cardiopulmonary bypass|
12051381|NCT00189202|Drug|Sirolimus|Thymoglobulin induction, sirolimus and no maintenance corticosteroid
12051382|NCT00189189|Behavioral|parent management training|
12051383|NCT00189176|Drug|Tetrathiomolybdate|
12051384|NCT00189163|Drug|Pioglitazone|30 mg, taken orally, once per day, for 48 weeks
12051385|NCT00189163|Drug|Placebo Oral Tablet|Sugar Pill, taken orally, once per day, for 48 weeks
12051386|NCT00189150|Drug|Mycophenolate mofetil|
12051387|NCT00189150|Drug|Valganciclovir|
12051388|NCT00189137|Drug|ifosfamide and doxorubicin vs gemcitabine and docetaxel|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
~Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
12051389|NCT00189124|Drug|Dehydroepiandrosterone (DHEA)|
12051390|NCT00189111|Procedure|Cardiac Imaging + Treatment|
12051391|NCT00189098|Drug|Sulfamethoxazole-trimethoprim|18 mg/kg, two times a day
12051392|NCT00189098|Drug|Placebo|
12051393|NCT00189085|Drug|simvastatin and ezetimibe|
12051394|NCT00189072|Drug|gabapentin|
12051395|NCT00189059|Drug|amitriptyline|
12051396|NCT00189046|Behavioral|driving and laboratory tests|
12051397|NCT00189033|Drug|psyllium fibre (dietary supplement)|
12051398|NCT00189033|Drug|wheat bran (dietary supplement)|
12051399|NCT00189033|Drug|rice wheat (placebo)|
12051400|NCT00189020|Biological|PCV7|PCV7 at age 2 and 4 months
12051401|NCT00189020|Biological|PCV7|PCV7 at age 2, 4 and 11 months
12051402|NCT00189007|Drug|Allopurinol sodium|Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
12051403|NCT00189007|Drug|Mannitol|Mannitol 500 mg/50 mL water for injection, intravenously, single dose
12051404|NCT00188994|Drug|Insulin Cardioplegia|
12051405|NCT00188968|Procedure|Nasal Continuous Positive Airway Pressure|
12051406|NCT00188968|Procedure|Synchronized Nasal Positive Pressure Ventilation|
12051407|NCT00188955|Drug|sirolimus|
12051408|NCT00188942|Drug|Fluoxetine+Olanzapine|
12051409|NCT00188942|Drug|Olanzapine|
12051410|NCT00188942|Procedure|Functional Magnetic Resonance Imaging|
12051411|NCT00188929|Procedure|PET Scan with [18F]Fluoro-2-deoxyglucose (FDG)|
12051412|NCT00188903|Procedure|Diastolic measurements during TEE|Transesophageal echocardiography with diastolic measurements
12051413|NCT00188877|Procedure|intensity modulated radiation therapy|
12051414|NCT00188877|Drug|cisplatinium and fluorouracil - standard treatment|
12051415|NCT00188864|Drug|dexamethasone|
12051416|NCT00188851|Drug|therapeutic management strategy|
12051417|NCT00188838|Behavioral|Psychoeduction|
12051418|NCT00188838|Behavioral|Cognitive-Behavioral Therapy|
12051419|NCT00188825|Other|placebo|
12051420|NCT00188825|Drug|basiliximab|
12051421|NCT00188812|Drug|donepezil hcl|
12051422|NCT00188799|Procedure|daily Xray volume imaging for planning radiotherapy|
12051423|NCT00188786|Procedure|daily Cone Beam CT for imaging guidance for radiotherapy|
12051424|NCT00188773|Drug|N-acetylcysteine, intralipid, heparin|One visit subject will receive N-acetylcysteine plus intralipid and heparin, another visit n-acetylcyksteine plus saline, another visit intralipid and heparin and another visit saline alone
12051425|NCT00188747|Procedure|Thromboelastograph, Point of Care|
12051426|NCT00188708|Procedure|hypoxia measurement|transrectal oxygen measurement
12051427|NCT00188695|Procedure|MRI contrast agent Combidex (ferumoxtran-10)|Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.
12051428|NCT00188669|Drug|pentoxifylline|
12051429|NCT00188669|Drug|alpha-Tocopherol|
12051431|NCT00188643|Drug|Venlafaxine and Lamotrigine|
12051432|NCT00188630|Drug|N-acetylcysteine|
12051433|NCT00188630|Other|5% dextrose solution|
12051434|NCT00188617|Drug|GEFITINIB|250 mg once a day for 28 days before surgery
12051435|NCT00188604|Drug|sodium selenite|
12051436|NCT00188578|Procedure|Intensity Modulated Radiation Therapy Boost|All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks
12051437|NCT00188565|Drug|Celecoxib|
12051438|NCT00188552|Drug|pentoxifylline|
12051439|NCT00188552|Drug|α-Tocopherol|
12051440|NCT00188539|Procedure|Pre-treatment tumour oxygen measurements (under anesthesia)|
12051441|NCT00188526|Device|lung biopsy|
12051442|NCT00188513|Procedure|conformal intensity modulated radiotherapy (IMRT)|
12051443|NCT00188500|Behavioral|atkins diet|
12051444|NCT00188500|Behavioral|ability to follow low carbohydrate diet|
12051445|NCT00188487|Device|magnetic resonance imaging (MRI) of the thorax|
12051446|NCT00188474|Behavioral|LCADLS, FACIT-PAL, FACIT-TS questionnaires|LCADLS, FACIT-PAL, FACIT-TS questionnaires
12051447|NCT00188461|Device|CT Thorax|
12051448|NCT00188448|Device|MRI|
12051449|NCT00188435|Procedure|Minimum Dose CT|
12051450|NCT00188422|Procedure|low dose CT|
12051451|NCT00188409|Procedure|CT scan|
12051452|NCT00188396|Drug|Citalopram|
12051453|NCT00188383|Drug|Amantadine|
12051454|NCT00188370|Procedure|high frequency ultrasound imaging|
12051455|NCT00188357|Behavioral|Education|
12051456|NCT00188344|Procedure|pneumatic dilatation|"The patient is on a liquid diet for 2 days prior to procedure. A sedative and pain killer by IV are given and the throat will be sprayed with local anesthetic.
~The gastroenterologist may perform an endoscopy prior to the dilatation to safely guide the dilator into position. A special dilator with a small balloon will be passed down the esophagus until it meets the stomach then the balloon will be inflated with air until the narrow part of the esophagus is opened. The patient will then be assessed for any perforation of the esophagus and monitored in the post-procedure unit for a few hours."
12051457|NCT00188344|Procedure|laparoscopic myotomy with partial fundoplication|The abdomen is inflated with gas and cameras and instruments are inserted. The junction between the esophagus and stomach is identified. The muscle of the lower esophageal sphincter is divided. A portion of the stomach wall is secured to the lower esophagus. After surgery the patient is taken to the recovery room and when well enough moved to a ward. The patient may be discharged the following day.
12051458|NCT00188331|Behavioral|Neuropsychological Testing|neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
12051459|NCT00188318|Procedure|hyperfractionated accelerated radiotherapy|
12051460|NCT00188305|Behavioral|General health counselling and risk information|General health counselling and risk information
12051461|NCT00188279|Procedure|Minimum Dose Computed Tomography (MnDCT) scan|Minimum Dose Computed Tomography (MnDCT) scan at regular follow up intervals for up to 5 years post-operatively.
12051462|NCT00188266|Drug|cisplatinum combined with infusional fluorouracil (5 FU)|Continuous 5FU via intravenous PICC line + 4 doses of Cisplatin every 2 weeks
12051463|NCT00188240|Drug|Pegasys; Copegus.|
12051464|NCT00188227|Drug|Midazolam (sedative)|
12051465|NCT00188227|Drug|Piritramid (analgetic)|
12051466|NCT00188227|Behavioral|Cognitive exercises|
12051467|NCT00188214|Procedure|contrast-enhanced dynamic CT perfusion study|contrast-enhanced dynamic CT perfusion study pre treatment and post treatment
12051468|NCT00188188|Drug|quinipril|
12051469|NCT00188175|Radiation|Intensity Modulated Radiation Therapy|Pre-op Intensity Modulated Radiation Therapy for lower limb soft tissue sarcoma.
12051470|NCT00188162|Device|CT|
12051471|NCT00188149|Drug|Combined chemotherapy (ABVD, BACOPP-D)|
12051472|NCT00188149|Procedure|Radiation therapy|
12051473|NCT00188136|Drug|Melphalan, ATG, Fludarabine|allo Tx during aplasia
12051474|NCT00188110|Procedure|Water-Enema Computed Tomography|
12051475|NCT00188097|Behavioral|Diagnosis of variceal bleeding and dits control in cirrhosis|
12051476|NCT00188084|Procedure|DNA Index|
12051477|NCT00188084|Procedure|S-Phase%|
12051478|NCT00188084|Procedure|CD45 expression|
12051479|NCT00188084|Procedure|P16 metabolic way|
12051480|NCT00188071|Drug|paracetamol|
12051481|NCT00188071|Drug|ketoprofen|
12051482|NCT00188071|Drug|ketoprofen + paracetamol|
12051483|NCT00188058|Device|Setting of positive end-expiratory pressure|
12051484|NCT00188045|Drug|Propranolol - Spironolactone|
12051485|NCT00188032|Procedure|Computer-Assisted diagnostic Decision Support|
12051486|NCT00188032|Procedure|written diagnostic guidelines|
12051487|NCT00188032|Procedure|electronic therapeutic reminders|
12051488|NCT00188019|Procedure|diagnosis methods|
12051489|NCT00188006|Device|heparin-coated cardiopulmonary bypass|
12051490|NCT00187993|Drug|Growth hormone|
12051491|NCT00187967|Device|pumps used for cardiopulmonary bypass|
12051492|NCT00187941|Drug|Mycophenolate Mofetil|Targeted MPA exposure to 30-60 mg/L/h during the first month post-transplant.
12051493|NCT00187928|Drug|Topiramate|
12051494|NCT00187915|Drug|Mycophenolate mofetil + Tacrolimus|Target MPA exposure to 30-60 mg/L/h during first month post-transplant
12051495|NCT00187915|Drug|Mycophenolate mofetil + Cyclosporin|Target MPA exposure to 30-60 mg/L/h during first month post-transplant
12051496|NCT00187889|Drug|Eplerenone|Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
12051497|NCT00187889|Drug|Placebo or sugar pill|Placebo blinded as 25 mg tablet(1 pill) once daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
12051498|NCT00187876|Procedure|ACL reconstruction control|The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
12051499|NCT00187876|Procedure|ACL Biocleanse, surgical|The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
12051500|NCT00187863|Behavioral|pain perception|pain perception
12051501|NCT00187850|Procedure|PP|Partial pulpotomy
12051502|NCT00187850|Procedure|DPC|Direct pulp capping
12051503|NCT00187837|Procedure|SW|Stepwise removal of carious tissue in 2 stages
12051504|NCT00187837|Procedure|DCE|one complete excavation
12051505|NCT00187811|Procedure|Delta amino leavulinic acid photodynamic therapy|
12051506|NCT00187798|Drug|Metformin HCl|Subjects will be given a single oral dose in tablet form containing 850 mg of metformin
12051507|NCT00187785|Behavioral|Spanish speaker level|
12051508|NCT00187772|Behavioral|Child-Parent Psychotherapy (CPP)|
12051509|NCT00187759|Drug|cephalexin|
12051510|NCT00187746|Drug|Adefovir dipivoxil|Subjects will be given a single oral dose of 10 mg of adefovir dipivoxil
12051511|NCT00187733|Other|Fasting blood and urine collection|Not applicable no drugs dispensed
12051512|NCT00187720|Drug|Metformin|Subjects will be given a single oral dose of 850 mg of metformin
12051513|NCT00187707|Drug|Gabapentin|Subjects will take a single dose of 400 mg of gabapentin
12051514|NCT00187681|Drug|Metformin|2 doses of Metformin Day 1 1000mg, Day 2 850 mg
12051515|NCT00187655|Drug|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
12051516|NCT00187629|Behavioral|dietary phosphorus|varying amts dietary phosphorus
12051517|NCT00187603|Behavioral|tobacco cessation program|
12051518|NCT00187590|Behavioral|Case manager phone call after an ER visit|
12051519|NCT00187577|Drug|Latanoprost (Xalatan)|
12051520|NCT00187577|Drug|Bimatoprost (Lumigan)|Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.
12051521|NCT00187577|Drug|Topical application of latanoprost solution to eyelid|Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily.
12051522|NCT00187564|Drug|controlled-release oral alpha-lipoic acid|
12051523|NCT00187551|Other|Interruption of enfuvirtide|treatment interruption
12051524|NCT00187551|Other|enfuvirtide interrupton|enfuvitide will be interrupted in patients harboring resistant virus
12051525|NCT00187538|Behavioral|Dietary|dietary
12051526|NCT00187525|Drug|Memantine|
12051527|NCT00187499|Drug|Inhaled fluticasone 500 ug BID for 8 weeks|
12051528|NCT00187486|Drug|Tarceva|Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status
12051529|NCT00187486|Drug|Temodar|Temodar 200 mg/m^2/day x 5 days every 28 days
12051530|NCT00187486|Procedure|Radiation Therapy|Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.
12051531|NCT00187473|Procedure|liver biopsy|Liver biopsy every 5 years
12051532|NCT00187460|Behavioral|Publicly released hospital cardiac report cards|Participating hospital corporations were randomized to either early feedback or delayed feedback (21 months later) in the form of publicly released hospital report cards of performance on a set of cardiac process-of-care quality indicators.
12051533|NCT00187447|Drug|indomethacin (two different dosing regimens)|
12051534|NCT00187434|Device|Infant Flow System|
12051535|NCT00187434|Device|Bubble CPAP|
12051536|NCT00187421|Procedure|Indocyanine green intraoperative angiogram and transit-time flowmetry|"ICG graft angiography following each distal anastomosis, and imaging of proximal anastomoses after all grafts completed.
~transit time flowmetry performed on all grafts after all grafts completed."
12051537|NCT00187408|Drug|Low Molecular Weight Heparin (dalteparin)|
12051538|NCT00187395|Procedure|Randomized to either a 'less tight' group or a 'tight' group|
12051539|NCT00187382|Drug|Multiple vs. single courses of antenatalcorticosteroids|
12051540|NCT00187369|Procedure|Method of Delivery|CS or VB
12051541|NCT00187356|Procedure|Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories|Each patient will receive both study grafts (Radial artery and Study Saphenous vein graft). The within-patient randomization scheme will dictate whether the radial goes to the right or circumflex territory. The saphenous vein graft will go to the opposing territory.
12051542|NCT00187343|Device|Breast IMRT|
12051543|NCT00187330|Drug|Intravenous N-acetylcysteine|
12051544|NCT00187317|Behavioral|Balance training (exercise)|Perturbation-based balance training. 30-minute sessions three times per week for six weeks.
12051545|NCT00187317|Other|Flexibility and relaxation exercise|30-minute sessions, three times per week for six weeks.
12051546|NCT00187304|Device|Aortic valve replacement|
12051547|NCT00187291|Device|T-Wave Alternans test|
12051548|NCT00187278|Device|Biventricular Pacing|Biventricular Pacemaker implant
12051549|NCT00187278|Device|RV Pacing|Standard Pacemaker implant
12051550|NCT00187265|Device|Cardiac Resynchronization Therapy|
12051551|NCT00187252|Device|Atrial Overdrive Pacing|Pacemaker/ ICD implant
12051552|NCT00187239|Device|Autointrinsic Conduction Search Algorithm|Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
12051553|NCT00187226|Procedure|Radiation Therapy|External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
12051554|NCT00187226|Procedure|Radiation Therapy|External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
12051555|NCT00187213|Device|Cardiac Resynchronization Therapy|
12051556|NCT00187200|Device|Simultaneous VV Pacing|Right ventricular and left ventricular pacing delivered simultaneously.
12051557|NCT00187200|Device|Sequential VV Pacing|Right ventricular and left ventricular pacing delivered sequentially.
12051558|NCT00187187|Device|Implantable Defibrillator (ICD)|Implantable Defibrillator (ICD)
12051559|NCT00187187|Device|Implantable Defibrillator (ICD)|Implantable Defibrillator (ICD)
12051560|NCT00187174|Drug|Everolimus|The drug is given orally in 28 day courses.
12051561|NCT00187161|Drug|Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin|The additional information is contained in the Detailed Description section.
12051562|NCT00187148|Biological|EnvDNA|administered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections
12051563|NCT00187135|Drug|Fentanyl|"Fentanyl - 1 mcg/kg in 3 ml normal saline
~Fentanyl - 0.5 mcg/kg in 3 ml normal saline"
12051564|NCT00187135|Drug|EMLA|All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours.
12051565|NCT00187135|Drug|L.M.X4|All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes.
12051566|NCT00187135|Drug|Propofol|Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex.
12051567|NCT00187122|Drug|Vincristine|See Detailed Description section for description of treatment plan.
12051568|NCT00187122|Procedure|Radiation Therapy|See Detailed Description section for description of treatment plan.
12051569|NCT00187122|Drug|Daunomycin|See Detailed Description section for description of treatment plan.
12051570|NCT00187122|Drug|L-Asparaginase|See Detailed Description section for description of treatment plan.
12051571|NCT00187122|Drug|Cytarabine|See Detailed Description section for description of treatment plan.
12051572|NCT00187122|Drug|Methotrexate|See Detailed Description section for description of treatment plan.
12051573|NCT00187122|Drug|Mercaptopurine|See Detailed Description section for description of treatment plan.
12051574|NCT00187122|Drug|Etoposide|See Detailed Description section for description of treatment plan.
12051575|NCT00187122|Drug|Cyclophosphamide|See Detailed Description section for description of treatment plan.
12051576|NCT00187122|Drug|Prednisone|See Detailed Description section for description of treatment plan.
12051577|NCT00187122|Drug|Dexamethasone|See Detailed Description section for description of treatment plan.
12051578|NCT00187109|Drug|Recombinant Human Thrombopoietin|
12051579|NCT00187096|Drug|Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2|See Detailed Description section for additional details of treatment interventions.
12051580|NCT00187096|Procedure|Natural Killer Cell Infusion|See Detailed Description section for additional details of treatment interventions.
12051581|NCT00187096|Device|CliniMACS System|See Detailed Description section for additional details of treatment interventions.
12051582|NCT00187083|Drug|Topotecan, dexamethasone, vincristine|See Detailed Description section for details of treatment interventions.
12051583|NCT00187083|Drug|E. coli Asparaginase, PEG-L-asparaginase|See Detailed Description section for details of treatment interventions.
12051584|NCT00187083|Drug|erwinia asparaginase|See Detailed Description section for details of treatment interventions.
12051585|NCT00187083|Drug|fludarabine, methotrexate, mercaptopurine|See Detailed Description section for details of treatment interventions.
12051586|NCT00187083|Drug|idarubicin, etoposide, cytarbine, teniposide|See Detailed Description section for details of treatment interventions.
12051587|NCT00187083|Procedure|chemotherapy, intrathecal chemotherapy, steroid therapy|See Detailed Description section for details of treatment interventions.
12051588|NCT00187070|Drug|Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine|See Detailed Description section for details of treatment interventions.
12051589|NCT00187070|Procedure|Stem cell transplant,|See Detailed Description section for details of treatment interventions.
12051590|NCT00187070|Radiation|Radiation Therapy|See Detailed Description section for details of treatment interventions.
12051591|NCT00187057|Drug|vinblastine, vincristine, prednisone, daunorubicin|See Detailed Description section for details of treatment interventions.
12051592|NCT00187057|Drug|doxorubicin, methotrexate, cyclophosphamide, L-asparaginase|See Detailed Description section for details of treatment interventions.
12051593|NCT00187057|Drug|etoposide, cytarabine, mercaptopurine|See Detailed Description section for details of treatment interventions.
12051594|NCT00187057|Drug|dexamethasone, procarbazine|See Detailed Description section for details of treatment interventions.
12051595|NCT00187057|Procedure|chemotherapy, intrathecal chemotherapy, steroid therapy|See Detailed Description section for details of treatment interventions.
12051596|NCT00187044|Biological|PolyEnv1 vaccine|administered subcutaneously as 10*7 pfu in 0.8 mL
12051597|NCT00187031|Drug|Topotecan, Filgrastim (G-CSF), Pegfilgrastim|See detailed description section for additional details.
12051598|NCT00187018|Biological|Bone marrow transplant|
12051599|NCT00187005|Drug|Prednisone, Dexamethasone, Vincristine, Daunorubicin, PEG-L-asparaginase|See Detailed Description section for details of treatment interventions.
12051600|NCT00187005|Drug|L-asparaginase, Methotrexate, Idarubicin, Etoposide, Cyclophosphamide, Cytarabine, Mercaptopurine|See Detailed Description section for details of treatment interventions.
12051601|NCT00186992|Radiation|image-guided radiotherapy|Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated.
12051602|NCT00186979|Drug|Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.|See Detailed Description section for details of treatment interventions.
12051603|NCT00186966|Drug|Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)|See Detailed Description section for details of treatment interventions.
12051604|NCT00186966|Drug|Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan|See Detailed Description section for details of treatment interventions.
12051605|NCT00186966|Procedure|Hematopoietic stem cell transplant|See Detailed Description section for details of treatment interventions.
12051606|NCT00186966|Radiation|Total body irradiation|See Detailed Description section for details of treatment interventions.
12051680|NCT00186472|Behavioral|Brief Cognitive Behavioral Treatment|
12051681|NCT00186459|Behavioral|Hypocaloric diet of varying macronutrient composition|
12051607|NCT00186953|Drug|Optison|"Intervention description:
~Based on recommendation by the FDA, we began with a dose of 0.125ml/m^2 and escalated at 0.15 ml/m^2 increments, to 0.275 ml/m^2 and 0.425ml/m^2 and 0.500ml/m^2. We will now continue to escalate the dose of Optison at 0.300ml/m^2 increments to a maximum single dose of 4ml or a total cumulative dose of 8.7 ml as recommended by the manufacturer."
12051608|NCT00186940|Drug|Rasburicase|Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.
12051609|NCT00186927|Biological|Sendai virus vaccine|Enders strain; a live, unmodified intranasally administered Sendai virus vaccine; given once in a dose escalation study, 5 x 10^5 to 5 x 10^7 EID(50) units.
12051610|NCT00186914|Biological|Marrow stromal cell infusion|"This is a pilot study of infusions of ex vivo expanded, gene marked donor bone marrow stromal cells following allogeneic bone marrow transplantation. The study is a within patient dose escalation safety evaluation. It is believed that this patient population may benefit from these donor stromal cell infusions.
~As the stromal cells will be obtained from the original stem cell donor, no conditioning is required.
~Patients will receive two infusions of mesenchymal cells (MSC) approximately 14 to 21 days apart unless there is unacceptable toxicity after the first infusion. The first dose of cells to be given will be 1x10^6 MSC/kg and the second dose of cells will be 5x10^6 MSC/kg. The patients will be followed for approximately 28 days following the second infusion for any toxicity. Only after all six patients have safely completed both infusions will we consider 5 x 10^6 MSC/kg a safe dose of allogeneic mesenchymal stem cells for infusion."
12051611|NCT00186901|Drug|Calcium carbonate (Tums), vitamin D|Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day
12051612|NCT00186901|Other|Placebo|Placebo
12051613|NCT00186888|Procedure|Enucleation|"Enucleation (possibly associated with all treatment strata/arms. For Stratum A, patients with bilateral disease will have surgery to remove the advanced eye before chemotherapy, or patients that have disease progression after chemotherapy may have surgery to remove the affected eye.
~For Stratum B, Surgical removal of the affected eye may be required in cases of disease progression For Stratum C, first intervention is removal of the affected eye."
12051614|NCT00186888|Drug|Vincristine, Carboplatin|(Stratum A subjects receive 8 courses every 3-4 weeks, Stratum B subjects receive this combination for Courses 3, 4, 6, 7, 9, and 10 after the window, if they respond to window therapy) Vincristine dosage< 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Carboplatin will be administered i.v. to achieve an AUC of 6.5 mg/ml/min, day 1.
12051615|NCT00186888|Procedure|Focal Therapies|Method will be at the discretion of the treating team, used after second course of chemotherapy. Cryotherapy- freezing of affected tissue, Laser photocoagulation- using lasers to destroy affected tissue, Thermotherapy and thermochemotherapy- using heat or heat/chemotherapy combination to destroy diseased tissue, and Episcleral plaque brachytherapy- radiation insertions in the diseased area to destroy affected tissue.
12051616|NCT00186888|Radiation|External Beam Radiation|44-46 Gy administered using standard practices , limiting dose to normal tissues to subjects with recurrent or progressive disease not considered controllable with focal treatments, Stratum B subjects with suspected active disease after completing therapy, or patients considered to have high-risk disease.
12051617|NCT00186888|Drug|Vincristine and Topotecan|(Stratum B subjects receive two up-front courses of vincristine and topotecan, given in 21-day intervals, then those who respond receive 3 additional courses (courses 5, 8, and 11) after the window. Dosages are the same for both window and subsequent courses: Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Topotecan: TSE of 140 ± 20 ng/ml*hr, daily for 5 consecutive days, infused over 30 minutes.
12051618|NCT00186888|Drug|Vincristine + Carboplatin + Etoposide|"Stratum B patients that do not respond to window receive 6 courses of this combination.
~Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Carboplatin will be administered i.v. to achieve an AUC of 6.5 mg/ml/min, day 1 Etoposide, < 12 months of age: 3.3 mg/kg/d i.v. days 1 - 3, ≥ 12 months of age: 100 mg/m2/d i.v. days 1 - 3"
12051619|NCT00186888|Drug|vincristine, cyclophosphamide, and doxorubicin|(High risk Stratum C patients in courses 2, 4, and 6 after enucleation, intermediate risk stratum C patients for four consecutive courses after enucleation) Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Cyclophosphamide: < 12 months of age: 40 mg/kg i.v. day 1, ≥ 12 months of age: 1,200 mg/m2 i.v. day 1, MESNA 200 mg/m2 at 0, 3, 6, and 9 hours Doxorubicin < 12 months of age: 1.5 mg/kg i.v. day 1, ≥ 12 months of age: 45 mg/m2 i.v. day 1
12051620|NCT00186888|Drug|Vincristine, Carboplatin and Etoposide|High risk Stratum C patients in courses 1, 3, and 5 after enucleation: Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Carboplatin will be administered i.v. to achieve an AUC of 6.5 mg/ml/min, day 1 Etoposide, < 12 months of age: 3.3 mg/kg/d i.v. days 1 - 3, ≥ 12 months of age: 100 mg/m2/d i.v. days 1 - 3
12051621|NCT00186888|Procedure|Periocular carboplatin|Periocular (subtenon) carboplatin 20 mg, one injection, in courses 5, 8, and 11 in patients responding to the VT window, and in courses 1, 3, and 6 of VCE in patients not responding to the VT window, when active vitreous disease is present. Carboplatin 20 mg will be diluted in 2 mL of NS or D5W and given by subtenon administration while the patient is under general anesthesia.
12051622|NCT00186888|Other|G-CSF|G-CSF (5 mcg/kg/day), will be administered starting 24-36 hours after the completion of each course of chemotherapy, for 7 to 10 days, until ANC is > 2,000/mL in one occasion after the expected nadir.
12051623|NCT00186875|Drug|Etoposide, cytarabine, vincristine, dexamethasone|See Detailed Description section for details of treatment interventions.
12051624|NCT00186875|Drug|methotrexate, teniposide, PEG-asparaginase|See Detailed Description section for details of treatment interventions.
12051625|NCT00186875|Drug|mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine|See Detailed Description section for details of treatment interventions.
12051626|NCT00186875|Drug|L-asparaginase, erwinia asparaginase|See Detailed Description section for details of treatment interventions.
12051627|NCT00186875|Procedure|chemotherapy, intrathecal chemotherapy, steroid therapy|See Detailed Description section for details of treatment interventions.
12051628|NCT00186875|Procedure|Hematopoietic Stem Cell Transplant|See Detailed Description section for details of treatment interventions.
12051629|NCT00186875|Procedure|Natural Killer (NK) Cell Transplant|See Detailed Description section for details of treatment interventions.
12051682|NCT00186446|Drug|bupropion and smoking cessation behavioral intervention|
12051630|NCT00186862|Drug|Interleukin-2|"A genetically modified (retroviral) allogeneic tumor vaccine coupled with the human interleukin-2. Patients were treated with 4 injections of these gene-modified tumor cells. The first two were given at weeks 1 and 2. Patients then had a 2 week rest and the remaining 2 injections were given at weeks 4 and 5. A complete evaluation for evidence of toxicity and response were performed at week 8.
~At this week 8 evaluation, if there was no excessive toxicity, progressive disease requiring therapy, and if more transduced cells are available, patients had the option to receive 4 additional injections. These additional injections were separated by 1 month at the higher of the two dosage levels originally received."
12051631|NCT00186849|Drug|Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, Carboplatin|See Detailed Description section for details of treatment interventions.
12051632|NCT00186849|Procedure|Peripheral Blood Stem Cell Transplant|See Detailed Description section for details of treatment interventions.
12051633|NCT00186836|Biological|Engerix-B and Twinrix|
12051634|NCT00186823|Device|Miltenyi Biotec CliniMACS|A stem cell selection device.
12051635|NCT00186823|Procedure|Stem Cell Transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
12051636|NCT00186823|Drug|TBI, systemic chemotherapy and antibodies as follows:|Transplant recipients received a myeloablative conditioning regimen consisting of total body irradiation, thiotepa, cyclophosphamide, ATG, and OKT3. Rituximab was provided prior to transplant for PTLPD prophylaxis. In addition to T cell depletion of the donor product, cyclosporine was administered for GVHD prophylaxis.
12051637|NCT00186810|Drug|Busulfan, Cyclophosphamide, Horse ATG|Transplant recipients received a myeloablative conditioning regimen of cyclophosphamide, Anti-Thymocyte Globulin (horse), and Busulfan. Cyclosporine and methotrexate were administered for GVHD prophylaxis.
12051638|NCT00186810|Procedure|Allogeneic stem cell transplant|Allogeneic stem cell transplant Matched sibling donor transplant Cord blood transplant
12051639|NCT00186797|Procedure|Allogeneic stem cell transplant|
12051640|NCT00186797|Drug|Fludarabine, Cyclophosphamide|
12051641|NCT00186784|Procedure|Transcranial Magnetic Stimulation (TMS)|treatment for 10 days
12051642|NCT00186771|Device|Paired Pulse|True treatment with rTMS over the temporoparietal cortex.
12051643|NCT00186771|Device|Paired Pulse|Sham treatment with rTMS over the temporoparietal cortex.
12051644|NCT00186758|Device|Transcranial Magnetic Stimulation (TMS)|"Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.
~Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -"
12051645|NCT00186745|Drug|Tinzaparin|Dose: 175 IU/kg subcutaneously once daily, up to 7 days. Dose reduction as per protocol if anti-Xa levels exceed pre-defined limits.
12051646|NCT00186732|Procedure|Subcuticular Suture|
12051647|NCT00186732|Procedure|Surgical Staples|
12051648|NCT00186706|Drug|Selenium|
12051649|NCT00186680|Procedure|high dose chemo then auto hematopoietic cell transplant|
12051650|NCT00186667|Procedure|high dose chemotherapy and autologous hematopoietic cell transplant|
12051651|NCT00186654|Procedure|Acupuncture|
12051652|NCT00186654|Procedure|Perinatal massage|
12051653|NCT00186641|Procedure|high dose chemo and auto hematopoietic cell transplant|
12051654|NCT00186628|Procedure|Total lymphoid irradiation|Total lymphoid irradiation (TLI) administered at 80cGy for 10 days
12051655|NCT00186628|Drug|Rituximab|Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.
12051656|NCT00186628|Drug|Anti-thymoglobulin, rabbit (ATG, rabbit ATG)|Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg.
12051657|NCT00186628|Drug|Cyclosporine|Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates > 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week).
12051658|NCT00186628|Drug|Mycophenylate mofetil|Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete
12051659|NCT00186628|Drug|Filgrastim|Filgrastim provided as needed for neutrophil support
12051660|NCT00186628|Drug|Granisetron|Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI
12051661|NCT00186628|Drug|Solumedrol|Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)
12051662|NCT00186628|Drug|Acetaminophen|Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC
12051663|NCT00186628|Drug|Diphenhydramine|Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC
12051664|NCT00186628|Drug|Hydrocortisone|Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC
12051665|NCT00186602|Behavioral|Peer counseling|
12051666|NCT00186589|Drug|90Y Ibritumomab tiuxetan|
12051667|NCT00186576|Procedure|nonmyeloablative allogeneic hematopoietic cell transplant|
12051668|NCT00186563|Procedure|Micro-plasmapheresis|
12051669|NCT00186550|Behavioral|Supportive Expressive Group Psychotherapy|
12051670|NCT00186550|Behavioral|Education|
12051671|NCT00186537|Drug|Rosiglitazone|
12051672|NCT00186537|Drug|Fenofibrate|
12051673|NCT00186537|Behavioral|Weight Loss|
12051674|NCT00186524|Behavioral|Breast Cancer Support Group|
12051675|NCT00186511|Behavioral|workbook/journal on coping with breast cancer|
12051676|NCT00186511|Behavioral|supportive expressive group therapy using videoconferencing|
12051677|NCT00186498|Drug|memantine|Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT
12051678|NCT00186498|Drug|Placebo Oral Capsule|Patients received a placebo capsule starting the day before ECT begins and while receiving ECT
12051679|NCT00186485|Device|MagStim|The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
12051683|NCT00186420|Drug|Taxotere|
12051684|NCT00186407|Procedure|high dose chemo then auto hematopoietic cell transplant|
12051685|NCT00186394|Procedure|ablative allogeneic hematopoietic cell transplantation|
12051686|NCT00186381|Procedure|high dose chemotherapy then autologous hematopoietic cell transplant|
12051687|NCT00186355|Procedure|high dose chemo then auto hematopoietic cell transplant|
12051688|NCT00186342|Procedure|ablative allogeneic hematopoietic cell transplantation|
12051689|NCT00186329|Drug|Natrecor, a recombinant form of B-type Natriuretic Peptide, made by Scios, Inc. vs. placebo|
12051690|NCT00186316|Biological|Idiotype-pulsed allogeneic dendritic cells|
12051691|NCT00186303|Procedure|high dose chemotherapy then autologous hematopoietic cell transplant|
12051692|NCT00186303|Procedure|ablative allogeneic hematopoietic cell transplant|
12051693|NCT00186290|Procedure|ablative allogeneic hematopoietic cell transplantation|
12051694|NCT00186277|Drug|Oxaliplatin|Calculated per patient
12051695|NCT00186277|Drug|Taxotere|Calculated per patient
12051696|NCT00186264|Drug|venlafaxine XR|
12051697|NCT00186264|Drug|hydrocortisone|
12051698|NCT00186251|Procedure|high dose chemo then auto hematopoietic cell transplant|
12051699|NCT00186238|Procedure|high dose chemotherapy then autologous hematopoietic cell transplant|
12051700|NCT00186225|Procedure|ablative allogeneic hematopoietic cell transplantation|
12051701|NCT00186212|Behavioral|workbook/journal on coping with breast cancer|
12051702|NCT00186212|Behavioral|standard educational materials on breast cancer|
12051703|NCT00186186|Drug|Depakote ER|Depakote ER
12051704|NCT00186173|Behavioral|After school sports program|After school team sports intervention designed specifically for overweight and obese children
12051705|NCT00186173|Behavioral|After school health education|After school health and nutrition education program
12051706|NCT00186147|Procedure|collection and storage of tissue samples for research|Tissue samples include blood draws for the donor and recipient. A bone marrow sample may be obtained from the recipient. If the recipient undergoes a tissue biopsy for clinical reasons, a small fraction may be removed for research purposes. A small fraction of the donor graft may be removed at the time of collection for research.
12051707|NCT00186134|Behavioral|physical activity|
12051708|NCT00186121|Drug|Anastrozole (Arimidex)|Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone
12051709|NCT00186121|Drug|Goserelin (Zoladex)|Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women
12051710|NCT00186108|Drug|Oral Triamcinalone|
12051711|NCT00186095|Procedure|autologous followed by nonmyeloablative allogeneic transplant|
12051712|NCT00186082|Drug|Cefotetan or Cefoxitin vs placebo|"Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously.
~Normal Saline, 100 ml intravenously for placebo arm."
12051713|NCT00186069|Drug|Magnesium Sulfate|Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.
12051714|NCT00186069|Other|Normal Saline|Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.
12051715|NCT00186056|Drug|Mifepristone|Glucocorticoid antagonist
12051716|NCT00186056|Drug|Placebo Oral Tablet|Inactive placebo tab
12051717|NCT00186043|Drug|Quetiapine/Seroquel|Quetiapine/Seroquel
12051718|NCT00186043|Drug|Placebo|Placebo
12051719|NCT00186030|Behavioral|HIV Skills-based Prevention|
12051720|NCT00186017|Drug|Olanzapine/Zyprexa|Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
12051721|NCT00186004|Device|Continuous Glucose Monitor|Subjects are fitted with a CGM system and perform self blood glucose measures three or more times per day for 3 days.
12051722|NCT00185991|Drug|gentamicin|"Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours).
~Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours)."
12051723|NCT00185978|Behavioral|diet, physical activity, reduced sedentary behavior|
12051724|NCT00185965|Drug|CPG 7909|6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
12051725|NCT00185952|Drug|Nifedipine|Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
12051726|NCT00185939|Drug|Augmentin|
12051727|NCT00185900|Drug|Magnesium Sulfate|Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.
12051728|NCT00185900|Drug|Nifedipine|Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
12051729|NCT00185887|Drug|Terbutaline|Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.
12051730|NCT00185874|Biological|Intratumoral Dendritic Cell Immunotherapy|
12051731|NCT00185874|Biological|autologous dendritic cells|
12051732|NCT00185861|Drug|Arsenic Trioxide|
12051733|NCT00185861|Procedure|Stereotactic radiosurgery|
12051734|NCT00185848|Radiation|[18F]FHBG|< 7mCi and 2 ug, iv
12051735|NCT00185835|Drug|ZD-1839|
12051736|NCT00185835|Drug|Cisplatin|
12051737|NCT00185796|Procedure|Total Lymphoid Irradiation (TLI)|TLI is administered ten times in 120cGy fractions on day -11 through day -7 and day -4 through day -1
12051738|NCT00185796|Procedure|Anti-Thymocyte Globulin as Conditioning (ATG)|Thymoglobulin will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg. Thymoglobulin doses will be based on the adjusted ideal body weight if the patient is greater than or equal to 15 kg over ideal body weight.
12051739|NCT00185783|Drug|Hydrocortisone Administration (Standard of Care Therapy)|
12051740|NCT00185770|Behavioral|Reducing television and other screen time (SMART curriculum)|
12051741|NCT00185757|Drug|Cytokine Induced Killer Cells|CIK cell dose escalation will be performed in cohorts of three patients per group. The initial dose utilized will be 1x107 expanded cells/kg. Previously, unmanipulated donor lymphocytes administered at this dose did not result in significant GVHD 7. The expansion of the CIK cell population is expected to diminish the T cell subsets responsible for GVHD further reducing the risk of GVHD to recipients. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients
12051742|NCT00185744|Radiation|Intra-Operative Radiotherapy (IORT)|single dose in the operating room after lumpectomy
12051743|NCT00185744|Procedure|Lumpectomy|
12051744|NCT00185744|Radiation|Whole Breast Radiotherapy|six and a half week treatment
12051745|NCT00185744|Radiation|Intracavitary Brachytherapy|5 day treatment
12051746|NCT00185744|Radiation|Accelerated External Beam 3-D Conformal Radiotherapy|5 day treatment
12051747|NCT00185744|Radiation|Stereotactic APBI|4 day treatment
12051748|NCT00185731|Drug|Atorvastatin|80 mg orally once daily
12051749|NCT00185705|Drug|Telmisartan|
12051750|NCT00185692|Procedure|non-myeloablative hematopoietic cell transplantation|TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
12051751|NCT00185692|Drug|Anti-Thymocyte Globulin|1.5 mg/kg QD x 5, IV. Dosage will be based on body weight. Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
12051752|NCT00185692|Drug|Cyclosporine|6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
12051753|NCT00185692|Drug|Mycophenolate Mofetil|15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively which blocks the de nobo synthesis of guanosine required for DNA synthesis and has an effect on T and B cells.
12051754|NCT00185692|Drug|G-CSF|16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
12051755|NCT00185692|Drug|Solumedrol|1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
12051756|NCT00185692|Drug|Acetaminophen|650 mg PO, 30 minutes prior to infusion Pain reliever
12051757|NCT00185692|Drug|Diphenydramine|50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
12051758|NCT00185692|Drug|Hydrocortisone|100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin
12051759|NCT00185679|Device|CliniMACS System|"The CliniMACS System is a cell selection device consisting of the following components:
~Computer-controlled instrument;
~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
~Wash buffer"
12051760|NCT00185666|Procedure|Stereotactic radiosurgery|
12051761|NCT00185653|Procedure|Autologous followed by non-myeloablative allogeneic transplantation|
12051762|NCT00185640|Drug|Cyclosporine|starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL
12051763|NCT00185640|Drug|Anti-Thymocyte Globulin|1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT
12051764|NCT00185640|Drug|mycophenolate mofetil|Begins on day 0 after HCT at a dose of 15 mg/kg. Patients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.
12051765|NCT00185640|Drug|Granulocyte-Colony Stimulating Factor|Received on day 0
12051766|NCT00185640|Radiation|Total Lymphoid Irradiation|0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.
12051767|NCT00185614|Procedure|Autologous hematopoietic cell transplant (Auto-HCT)|The target cell dose is 2.6 x 10e6 CD34+ cells/kg
12051768|NCT00185614|Procedure|Allogeneic hematopoietic cell transplant (Allo-HCT)|The target cell dose is 5 x 10e6 CD34 cells/kg
12051769|NCT00185614|Drug|Cyclophosphamide|Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
12051770|NCT00185614|Drug|Filgrastim|"Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT)
~Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT)
~Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)"
12051771|NCT00185614|Drug|Melphalan|Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
12051772|NCT00185614|Radiation|Total body irradiation (TBI)|200 centigray (cGy) total body irradiation delivered on Day 0
12051773|NCT00185614|Procedure|Cyclosporine (CSP)|Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
12051774|NCT00185614|Drug|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27
12051775|NCT00185601|Behavioral|Internet Diabetes Self-Management Program|
12051776|NCT00185588|Drug|Vatalanib|Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours
12051777|NCT00185588|Drug|Gemcitabine|850 mg/m2
12051778|NCT00185575|Drug|duloxetine|
12051779|NCT00185562|Drug|Adalimumab|
12051780|NCT00185549|Behavioral|CF. DOC|
12051781|NCT00185536|Behavioral|Packaging and identification of source|
12051782|NCT00185523|Procedure|Allogeneic hematopoietic cell transplantation|
12051783|NCT00185510|Drug|Methylprednisolone Aceponate (Advantan, BAY86-4862)|In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
12051784|NCT00185510|Drug|Placebo|2 days a week Vehicle (Advabase)
12051785|NCT00185484|Drug|YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)|Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles
12051829|NCT00185159|Drug|Olmesartan medoxomil|tablets
12051830|NCT00185159|Drug|Placebo Tablets|Tablets
12051831|NCT00185146|Drug|Pactimibe|
12051832|NCT00185133|Drug|Olmesartan medoxomil|
12051833|NCT00185133|Drug|Amlodipine|
12051834|NCT00185120|Drug|Olmesartan medoxomil|
12051835|NCT00185120|Drug|Hydroclorothiazide|
12051836|NCT00185120|Drug|Benazepril|
12051786|NCT00185458|Drug|LNG IUS|LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
12051787|NCT00185445|Drug|Fludarabine Phosphate (Fludara)|All patients will receive fludarabine phosphate orally for 3 consecutive days per cycle and mitoxantrone on day 1. Each patient will receive up to six treatment cycles. Treatment cycles will be given at 4 weeks intervals.
12051788|NCT00185419|Drug|Yasmin|30 µg ethinylestradiol, 3mg drospirenone
12051789|NCT00185419|Drug|Marvelon|30 µg ethinylestradiol, 150 µg desogestrel
12051790|NCT00185393|Biological|Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)|treatment with 90 Yttrium-labeled anti CD 20 antibody
12051791|NCT00185393|Other|no treatment|no treatment
12051792|NCT00185380|Drug|Levonorgestrel IUS (BAY86-5028, G04209B)|Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years
12051793|NCT00185380|Drug|Levonorgestrel IUS (BAY86-5028, G04209C)|Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years
12051794|NCT00185380|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years
12051795|NCT00185367|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658K)|7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo
12051796|NCT00185367|Drug|SH D 593 B (Miranova)|7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo
12051797|NCT00185354|Drug|BAY86-5016, SH P00331F|Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)
12051798|NCT00185354|Drug|SH P00331N|Drug amount per patch: 0.6 mg EE2 + 6 mg NGM
12051799|NCT00185341|Drug|CCR1-Antagonist (BAY86-5047, ZK811752)|Given orally in a dose of 600 mg three times daily over 12 weeks
12051800|NCT00185341|Drug|Placebo|Placebo
12051801|NCT00185328|Drug|Estradiol/DRSP (Angeliq, BAY86-4891)|1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles
12051802|NCT00185315|Drug|Ventavis (Iloprost, BAYQ6256)|Inhaled iloprost
12051803|NCT00185302|Drug|Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)|MS-275, 3 mg on Days 1 and 15 of a 4-week cycle
12051804|NCT00185302|Drug|Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)|MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle
12051805|NCT00185289|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658K)|per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo
12051806|NCT00185276|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight
12051807|NCT00185276|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight
12051808|NCT00185263|Genetic|AdF5FGF-4 vs. Placebo|Intracoronary infusion
12051809|NCT00185250|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
12051810|NCT00185250|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|2 MIU per application in week 1, 4 MIU per application in weeks 2 to 3 and 8 MIU per application in weeks 4 to 24 given subcutaneously every other day
12051811|NCT00185250|Drug|Placebo|0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
12051812|NCT00185250|Drug|Placebo|0.25 ml in week 1, 0.50 ml in weeks 2 to 3 and 1.00 ml in weeks 4 to 24 given subcutaneously every other day
12051813|NCT00185237|Drug|Menostar (estradiol transdermal delivery system)|Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
12051814|NCT00185237|Drug|Placebo|Placebo patch
12051815|NCT00185224|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658K)|7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo
12051816|NCT00185224|Drug|SH D00264A (Triquilar)|7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo
12051817|NCT00185211|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
12051818|NCT00185211|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
12051819|NCT00185198|Drug|Testogel (Testosterone, BAYV001915)|50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months
12051820|NCT00185198|Drug|Placebo|5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1
12051821|NCT00185185|Drug|Olmesartan medoxomil|
12051822|NCT00185185|Drug|Atenolol|
12051823|NCT00185185|Drug|Hydrochlorothiazide|tablets
12051824|NCT00185185|Drug|olmesartan medoxomil|tablets
12051825|NCT00185185|Drug|atenolol|tablets
12051826|NCT00185172|Other|placebo|Placebo oral tablets for 2 weeks
12051827|NCT00185172|Drug|olmesartan medoxomil|olmesartan medoxomil oral tablets for 8 weeks
12051828|NCT00185172|Drug|olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets|olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
12051838|NCT00185107|Drug|Colesevelam Hydrochloride|
12051839|NCT00185107|Drug|Ezetimibe|
12051840|NCT00185107|Drug|Simvastatin|
12051841|NCT00185094|Drug|Olmesartan medoxomil|
12051842|NCT00185094|Drug|Losartan potassium|
12051843|NCT00185094|Drug|Atenolol|
12051844|NCT00185081|Drug|Indium labeled IMP-205xm734|
12051845|NCT00185068|Drug|Olmesartan medoxomil|
12051846|NCT00185068|Drug|Olmesartan medoxomil/hydrochlorothiazide|
12051847|NCT00185068|Drug|Hydrochlorothiazide|
12051848|NCT00185055|Drug|Olmesartan medoxomil|
12051849|NCT00185055|Drug|Irbesartan|
12051850|NCT00185055|Drug|Valsartan|
12051851|NCT00185042|Drug|Pactimibe, CS-505|
12051852|NCT00185029|Procedure|Ferumoxtran-10 enhanced MRI (MRL)|
12051853|NCT00185016|Behavioral|a training to improve recognition of partner abuse.|
12051854|NCT00185003|Drug|endotoxin|
12051855|NCT00185003|Drug|Potassium channel blockers: TEA, Quinin, Tolbutamide|
12051856|NCT00185003|Drug|L-NMMA|
12051857|NCT00184990|Drug|Aminoguanidine|
12051858|NCT00184990|Drug|endotoxin|
12051859|NCT00184977|Drug|N-acetylcysteine|
12051860|NCT00184977|Drug|fluticasone propionate|
12051861|NCT00184964|Procedure|CT-scan, PET-scan|
12051862|NCT00184951|Drug|Rosuvastatin|
12051863|NCT00184938|Drug|morphine|
12051864|NCT00184938|Drug|naloxone|
12051865|NCT00184938|Drug|Technetium-TC99m-labeled Annexin A5|
12051866|NCT00184938|Procedure|forearm ischemic exercise|
12051867|NCT00184938|Procedure|ten minute forearm ischemia|
12051868|NCT00184925|Procedure|Tracheostomy|trachesotomy with subglottic drainage
12051869|NCT00184925|Device|cannula with subglottic drainage|
12051870|NCT00184912|Drug|caffeine|
12051871|NCT00184912|Drug|Technetium-TC99m-labeled Annexin A5|
12051872|NCT00184912|Procedure|ten minutes forearm ischemia|
12051873|NCT00184912|Procedure|ischemic forearm exercise|
12051874|NCT00184899|Drug|Intravenous infusion of Intralipid/heparin|
12051875|NCT00184899|Drug|Intravenous infusion of Glycerol/heparin|
12051876|NCT00184886|Drug|Methotrexate 15 mg/week for 12 weeks|
12051877|NCT00184873|Behavioral|Health Counseling|
12051878|NCT00184860|Procedure|PET-scan, MRI-scan|
12051879|NCT00184847|Drug|acetylcholine|
12051880|NCT00184847|Procedure|twenty minutes of forearm ischemia|
12051881|NCT00184847|Procedure|three 5-minute periods of forearm ischemia|
12051882|NCT00184847|Drug|adenosine|
12051883|NCT00184847|Drug|caffeine|
12051884|NCT00184834|Behavioral|quality of life|
12051885|NCT00184821|Procedure|Ischemic preconditioning|
12051886|NCT00184821|Procedure|Forearm ischemic exercise|
12051887|NCT00184821|Procedure|Annexin A5 scintigraphy|
12051888|NCT00184821|Drug|Diazoxide|
12051889|NCT00184821|Drug|glibenclamide|
12051890|NCT00184821|Drug|adenosine|
12051891|NCT00184795|Drug|0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)|One tablet per day for 24 weeks
12051892|NCT00184795|Drug|0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)|One tablet per day for 24 weeks
12051893|NCT00184795|Drug|placebo|Placebo tablets for 24 weeks
12051894|NCT00184782|Procedure|FDG-PET|
12051895|NCT00184769|Drug|somatropin|
12051896|NCT00184756|Drug|somatropin|
12051897|NCT00184743|Drug|somatropin|
12051898|NCT00184730|Drug|somatropin|
12051899|NCT00184717|Drug|somatropin|0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
12051900|NCT00184717|Drug|somatropin|0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
12051901|NCT00184691|Drug|somatropin|
12051902|NCT00184678|Drug|somatropin|
12051903|NCT00184665|Drug|insulin detemir|
12051904|NCT00184665|Drug|insulin NPH|
12051905|NCT00184665|Drug|insulin aspart|
12051906|NCT00184652|Drug|somatropin|
12051907|NCT00184639|Drug|insulin detemir|
12051908|NCT00184626|Drug|biphasic insulin aspart|
12051909|NCT00184626|Drug|insulin glargine|
12051910|NCT00184626|Drug|metformin|
12051911|NCT00184613|Device|pump|
12051912|NCT00184613|Drug|insulin glargine|
12051913|NCT00184613|Drug|insulin aspart|
12051914|NCT00184600|Drug|biphasic insulin aspart|Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
12051915|NCT00184600|Drug|insulin detemir|Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
12051916|NCT00184600|Drug|insulin aspart|Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
12051917|NCT00184587|Drug|candesartan cilexetil|
12051918|NCT00184587|Drug|placebo|
12051919|NCT00184574|Drug|biphasic insulin aspart|
12051920|NCT00184574|Drug|metformin|
12051921|NCT00184561|Drug|biphasic insulin aspart|
12051922|NCT00184548|Drug|eptacog alfa (activated)|"Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.
~Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours."
12051923|NCT00184548|Drug|placebo|placebo
12051924|NCT00184522|Drug|Aflurax|
12051925|NCT00184522|Drug|esomeprazole|
12051926|NCT00184509|Behavioral|integrated psychosocial treatment (behavior)|
12051927|NCT00184496|Drug|Methadone|To methods for switching morphine to methadon. Stop-and go versus overlap
12051928|NCT00184483|Procedure|Lichtenstein's operation|Lichtenstein's operation to repair primary unilateral inguinal hernia
12051929|NCT00184483|Procedure|Prolene Hernia System|Prolene Hernia System to repair primary unilateral inguinal hernia
12051930|NCT00184457|Behavioral|Strength training intervention|
12051931|NCT00184444|Behavioral|Hypoxic interval training|4 x 4 minutes interval training in hypoxic air, 3 times per week at 90-95% HR max
12051932|NCT00184444|Behavioral|Normoxic interval training|4 x 4 minutes normoxic interval training, 3 times per week at 90-95% HR max
12051933|NCT00184431|Behavioral|Physical therapy technique and exercises|The experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period.
12051934|NCT00184392|Procedure|debridement or saline irrigation|debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery
12051935|NCT00184379|Behavioral|Psychoeducation|Structured disorder-related educational program for relatives
12051936|NCT00184366|Drug|efalizumab|efalizumab
12051937|NCT00184340|Device|eTherapy|secured e-mail system between patient and therapist
12051938|NCT00184327|Behavioral|Intensive family therapy - inpatient|2-4 weeks (5days) family inpatient assessment and treatment
12051939|NCT00184327|Behavioral|Diagnostic assessment - child and adolescent psychiatry|
12051940|NCT00184301|Behavioral|inpatient treatment|inpatient treatment during 1 year
12051941|NCT00184301|Behavioral|outpatient treatment|intensive outpatient treatment consisting of two-weekly group sessions during 1 year
12051942|NCT00184262|Behavioral|ERP cognitive therapy|15 exposure and response prevention (ERP) sessions in 3 months with a cognitive therapy rationale
12051943|NCT00184262|Behavioral|ERP behavioral therapy|15 exposure and response prevention (ERP) sessions in 3 months with a behavioral therapy rationale
12051944|NCT00184249|Procedure|Bipolar radiofrequency ablation|Ablation using CE marked bipolar ablation devices
12051945|NCT00184236|Behavioral|Multitreatment approach|12 months regimen consisting of group meetings every 2 weeks involving a physician, psychologist, physiotherapist and clinical nutritional physiologist. 21 h treatment during the first 3 months: 3 activity sessions (3 h) and 3 group conversations (4 h). Attendance inclusion criterium was set to minimum of 80%
12051946|NCT00184236|Behavioral|Aerobic interval training|Walking/running 'uphill' on a treadmill twice a week for 3 months. 10 min warming-up at 70% of Hfmax before performing 4x4 intervals at 90-95% of Hfmax. 3 min active recovery at 70% of Hfmax between each interval. 5 min cool-down period, giving a total of 40 min.
12051947|NCT00184223|Behavioral|Motivational Interviewing|2 sessions of 45 minutes each with manual guided motivational interviewing delivered individually by a trained therapist.
12051948|NCT00184223|Other|Treatment as usual|Treatment as usual is individualized according to the clinical condition of the patients during the stay and in accordance with general national and international medical standards. It includes detoxification, pharmacotherapy, and general psychotherapy. Also, treatment is given for any coexisting non-substance-related disorder, including psychiatric disorders.
12051949|NCT00184197|Drug|Botulinum toxin|
12051950|NCT00184197|Drug|Placebos|
12051951|NCT00184171|Drug|Budesonide|Budesonide 9 mg
12051952|NCT00184171|Drug|Bismuth|Bismuth mixture
12051953|NCT00184171|Drug|Fiber|Fiber for control
12051954|NCT00184158|Procedure|decompression|Conservative, simple decompression and nerve transfer
12051955|NCT00184145|Other|EMDR (Eye Movement Desensitization and Reprocessing)|Psychotherapy which is approved for PTSD.
12051956|NCT00184145|Other|Exposure therapy|All participants in the study received exposure therapy som second treatment. Exposure therapy is the therapy of choice for animal phobia.
12051957|NCT00184132|Procedure|Psychiatric intensive care unit in Norwegian home style|
12051958|NCT00184132|Procedure|Psychiatric intensive care unit sparsely furnished and not decorated|
12051959|NCT00184119|Procedure|Psychiatric Intensive Care Unit|
12051960|NCT00184119|Procedure|Care in whole acute unit|psychiatric acute care as usual
12051961|NCT00184106|Drug|Seroxat, Cognitive therapy, Seroxat+ cognitive therapy|Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
12051962|NCT00184093|Drug|Gemcitabine|Gemcitabine weekly x 6 wks with concurrent external radiation
12051963|NCT00184080|Drug|Elsamitrusin|
12051964|NCT00184067|Biological|Montanide ISA 51|
12051965|NCT00184054|Drug|Arsenic Trioxide (ATO)|Arsenic Trioxide .25 mg/kg/day
12051966|NCT00184054|Drug|Ascorbic Acid|Ascorbic Acid 1000 mg every other day for 25 days
12051967|NCT00184041|Drug|Daunorubicin, Vincristine, Prednisone, Methotrexate, PEG-Asparaginase, 6-Mercaptopurine, Cytoxan, Cytosine Arabinoside, VM-26 and 6-Thioguanine|Induction I/II, consolidation I/II/III/IV and Maintenance
12051968|NCT00184028|Drug|Taxotere|Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
12051969|NCT00184028|Drug|Oxaliplatin|Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
12051970|NCT00184015|Drug|Bevacizumab and Bortezomib|Bevacizumab 15 mg/kg on day 1 with Bortezomib 1.0 or 1.3 mg/m2 on days 1, 4, 8 and 11 every 21 days
12051971|NCT00184015|Drug|Bevacizumab and Bortezomib|Bevacizumab 15 mg/kg on day 1 with Bortezomib 1.6 or 1.8 mg/m2 on days 1 and 8 every 21 days
12051972|NCT00184002|Drug|Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone|"Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.
~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.
~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).
~Prednisone 100 mg po days 1-5.
~Cycle 2 until study completion
~Doxil 40 mg/m2 iv day 1
~Rituxan 375 mg/m2 iv day 1
~Cyclophosphamide 750 mg/m2 iv day 1
~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum)
~Prednisone 100 mg po days 1-5
~1 cycle = 21 days.
~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles."
12051973|NCT00183989|Drug|Fludarabine, Mitoxantrone and Rituximab|
12051974|NCT00183976|Drug|Pegylated Liposomal Doxorubicin (Doxil) and Rituximab|
12051975|NCT00183963|Drug|Tamoxifen|20mg
12051976|NCT00183963|Drug|Fulvestrant|250mg
12051977|NCT00183963|Drug|Fulvestrant|500 mg IM
12051978|NCT00183950|Drug|Noscapine|
12051979|NCT00183937|Drug|PS 341|PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
12051980|NCT00183937|Drug|Docetaxel|Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
12051981|NCT00183924|Drug|Estramustine|
12051982|NCT00183924|Drug|Docetaxel|
12051983|NCT00183924|Drug|Carboplatin|
12051984|NCT00183911|Drug|floxuridine, 5-Fluorouracil, leucovorin|
12051985|NCT00183911|Procedure|External Beam Radiotherapy|
12051986|NCT00183911|Procedure|Surgery|
12051987|NCT00183898|Drug|oxaliplatin, capecitabine|cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
12051988|NCT00183885|Drug|mitomycin-c, cisplatin|Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
12051989|NCT00183872|Drug|irinotecan, docetaxel|docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
12051990|NCT00183859|Drug|irinotecan|Intraperitoneal Irinotecan given every three weeks
12051991|NCT00183846|Drug|irinotecan|
12051992|NCT00183846|Procedure|radiation therapy|
12051993|NCT00183833|Drug|capecitabine, imatinib mesylate|Capecitabine and imatinib mesylate will both be taken by mouth twice a day
12051994|NCT00183820|Drug|paclitaxel, gemcitabine, and oxaliplatin|"Paclitaxel 170 mg/m2 IV d 1 14 days
~Gemcitabine 800 mg/m2 IV d 1 14 days
~Oxaliplatin 100 mg/m2 IV d 1 14 days"
12051995|NCT00183807|Drug|irinotecan, cisplatin, celecoxib|
12051996|NCT00183794|Drug|Docetaxel and Gemcitabine|Docetaxel 75 mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8 of each 3 weeks (21 days) cycle.
12051997|NCT00183781|Behavioral|FITT: Family Intervention - Telephone Tracking|
12051998|NCT00183768|Behavioral|Cognitive Behavioral Therapy|
12051999|NCT00183768|Behavioral|Psychopharmacology|
12052000|NCT00183742|Drug|liposomal doxorubicin and docetaxel|
12052001|NCT00183729|Drug|Memantine|Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
12052002|NCT00183729|Other|Placebo|Placebo distribution is planned to mimic the active drug.
12052003|NCT00183716|Behavioral|Trauma Recovery and Empowerment Model (TREM)|TREM is a 29-session group intervention for women who have experienced psychological trauma (e.g., childhood physical or sexual abuse), focusing on skill development, understanding the effects of trauma, and empowerment.
12052004|NCT00183716|Behavioral|Usual care|Participants will receive usual care for women who have experienced psychological trauma.
12052005|NCT00183690|Procedure|Prolonged Exposure Therapy|Prolonged exposure therapy includes a trauma focused protocol and cognitive behavioral treatment for PTSD. Cognitive behavioral treatment includes psychoeducation, in vivo exposures, and imaginal exposures.
12052006|NCT00183690|Procedure|Active Psychotherapy|Active psychotherapy includes non-trauma focused therapy, based on time-limited psychodynamic treatment, which includes a formulation of a central issue and open-associative sessions exploring main conflicts and drives.
12052007|NCT00183677|Drug|Escitalopram|Escitalopram 10 to 30 mg per day for 12 weeks
12052008|NCT00183651|Behavioral|Standard dialectical behavior therapy (SDBT)|Standard DBT includes: 1) individual DBT therapy (1 hour per week), 2) DBT group skills training (2.5 hours per week), 3) telephone consultation (as needed), and 4) therapist consultation team (1 hour per week).
12052009|NCT00183651|Behavioral|Individual DBT with no DBT group sessions (DBT-I)|Individual DBT (DBT-I) is 1 hour per week of individual therapy and 2.5 hours per week with the psychosocial activities group.
12052010|NCT00183651|Behavioral|Group Skills DBT with no DBT individual sessions (DBT-S)|DBT group skills training is 2.5 hours per week and includes individual case management.
12052011|NCT00183638|Behavioral|Internet-based tailored prevention messages|Participants will receive five 30-second flash clips promoting condom norms, positive attitudes, self-efficacy, and risk awareness. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage.
12052012|NCT00183638|Behavioral|Non-tailored messages|The control program will deliver five general, non-tailored messages containing information on reproductive health not specific to condoms or STDs.
12052013|NCT00183625|Behavioral|Individual Placement and Support (Supported Employment)|
12052014|NCT00183625|Behavioral|Social Skills Training|
12052015|NCT00183625|Drug|Olanzapine|
12052016|NCT00183625|Drug|Risperidone|
12052017|NCT00183612|Drug|Olanzapine|
12052018|NCT00183599|Behavioral|5 Minutes of Simple Advice|
12052019|NCT00183599|Behavioral|Motivational Enhancement Therapy (MET)|
12052020|NCT00183599|Behavioral|Cognitive Behavioral Therapy (CBT)|
12052021|NCT00183586|Behavioral|Family therapy (FT)|FT is a family-based treatment that will be given for a total of 24 hours over the course of 12 months.
12052022|NCT00183586|Behavioral|Individual therapy (IT)|IT is an ego-oriented psychotherapy treatment that will be given for a total of 24 hours over the course of 12 months.
12052023|NCT00183573|Behavioral|Brief Motivational Intervention|15-20 minute, motivational one-on-one counseling
12052024|NCT00183573|Behavioral|Brief Informational Intervention|15 minute informational DVD on safer sex
12052025|NCT00183573|Behavioral|Intensive Informational Intervention|4-hour, information-only intensive group workshop
12052026|NCT00183573|Behavioral|Intensive Info-Motivation-Behavioral Skills Intervention|4-hour, intensive group workshop with emphasis on motivation and skills
12052027|NCT00183560|Behavioral|Mindfulness based cognitive therapy (MBCT)|Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.
12052028|NCT00183560|Drug|Antidepressants|Participants continue on dosage of the antidepressant that was used to achieve clinical remission.
12052029|NCT00183560|Drug|Placebo plus clinical management|Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.
12052030|NCT00183547|Behavioral|"Living in Harmony depression prevention program"|Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support
12052031|NCT00183547|Behavioral|Depression-prevention education and support|Weekly therapy sessions offering general depression-prevention education and support
12052063|NCT00183339|Drug|Placebo|Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
12052032|NCT00183521|Behavioral|Raise-CO2 breathing regulation training|Reverse hyperventilation (defined by low arterial CO2) is often characteristic of individuals with panic disorder. Participants will be randomly assigned to one of three groups: raise-CO2 breathing, lower-CO2 breathing, or a control group. Participants in the raise-CO2 group will be taught techniques to recover from hyperventilation faster.
12052033|NCT00183521|Behavioral|Lower-CO2 breathing regulation training|According to the false suffocation alarm theory, anxiety is experienced when an overly sensitive hypothalamic mechanism is triggered by rising pCO2. Participants in the lower-CO2 group will be taught techniques to reach hyperventilation levels, then switch to breathing techniques that reduce hyperventilation symptoms.
12052034|NCT00183521|Behavioral|Control|Participants in the control group will not be taught any breathing techniques but will be included in all assessments.
12052035|NCT00183508|Behavioral|Cognitive behavioral therapy|Participants will learn cognitive behavioral strategies for symptom reduction
12052036|NCT00183508|Behavioral|Psychoeducation|Participants will receive psychoeducation regarding common reactions to traumatic events
12052037|NCT00183482|Behavioral|Family Group Cognitive Behavioral|Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions
12052038|NCT00183482|Behavioral|Written Information|Families are mailed written materials that describe depression and stress in families with a depressed parent.
12052039|NCT00183469|Drug|Lamotrigine|If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects.
12052040|NCT00183469|Drug|Divalproex (DIV) ER|If the participant is naive to DIV and if LAM was initiated before the start of treatment with DIV, DIV can be started at any point of time in the study provided the participant has been on LAM for at least 2 weeks. DIV will be started at 500 mg and titrated by increments of 500 mg every 3 to 4 days until a therapeutic blood level is attained up to 2500 mg.
12052041|NCT00183469|Drug|Placebo|During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fashion.
12052042|NCT00183456|Behavioral|Peer-oriented intervention|The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.
12052043|NCT00183456|Behavioral|Group cognitive behavioral therapy (CBT)|Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
12052044|NCT00183443|Drug|Divalproex-extended release (DVP-ER)|Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
12052045|NCT00183443|Drug|Lithium|Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
12052046|NCT00183443|Drug|Quetiapine|Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
12052047|NCT00183430|Drug|Prazosin|Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
12052048|NCT00183430|Drug|Placebo|Placebo capsules are taken orally twice per day at 10 am and bedtime.
12052049|NCT00183430|Behavioral|Psychotherapy|All participants will undergo psychotherapy during medication treatment period.
12052050|NCT00183417|Behavioral|Cognitive behavior therapy (CBT)|Participants will complete worksheets and group discussion on how to increase positive mood and activity.
12052051|NCT00183417|Behavioral|Supportive/expressive (S/E) therapy|Participants will be encouraged to express feelings and emotions without advice giving.
12052052|NCT00183417|Behavioral|Bibliotherapy|Participants will be given a book on how to increase their mood.
12052053|NCT00183404|Drug|Olanzapine|Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
12052054|NCT00183391|Drug|Atomoxetine|Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
12052055|NCT00183391|Drug|Methylphenidate|Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
12052056|NCT00183378|Behavioral|Walking Program|The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.
12052057|NCT00183378|Behavioral|Light Exposure Program|The therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour.
12052058|NCT00183378|Behavioral|Combined Education, Walking and Light Exposure Program|The therapist provides a combination of education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.
12052059|NCT00183378|Behavioral|Routine Medical Care with Education|The therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. Participants are free to use whatever medical services they wish during study participation.
12052060|NCT00183365|Behavioral|Parent Skills Training|Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.
12052061|NCT00183365|Behavioral|Protecting Families Program (PFP)|Participants will receive 10 weeks of PFP, which will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child.
12052062|NCT00183339|Drug|Fluoxetine|Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
12052064|NCT00183326|Behavioral|Trauma-focused cognitive behavioral therapy (TF-CBT)|TF-CBT is a psychotherapeutic intervention designed to help children, youth, and their parents overcome the negative effects of traumatic life events. It was developed by integrating cognitive and behavioral interventions with traditional child abuse therapies that focus on enhancement of interpersonal trust and empowerment. It targets PTSD symptoms, which often co-occur with depression and behavioral problems. TF-CBT also targets other issues experienced by those suffering a trauma including poor self-esteem, mood instability, and difficulty trusting others.
12052065|NCT00183326|Behavioral|Child-centered supportive therapy (CCT)|CCT demonstrates an empathic approach to healing. An environment consisting of empathy, unconditional positive regard and acceptance are key elements in this mode of therapy.
12052066|NCT00183313|Behavioral|Nurse case management|Nurse case management is a population-based medical case management program to improve the delivery of primary medical care to patients with serious mental illness in a Community Mental Health Center (CMHC) in Atlanta GA. The treatment draws on elements from the primary care, nursing case management, chronic disease, health behavior change literature, and from the study team's experience in integrating primary care services for patients with serious mental illnesses.
12052067|NCT00183313|Behavioral|Usual care|Usual care includes standard mental health services.
12052068|NCT00183300|Behavioral|Prolonged Exposure Therapy|
12052069|NCT00183274|Drug|Venlafaxine XR|Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d
12052070|NCT00183274|Drug|Placebo|six month intervention with placebo drug
12052071|NCT00183261|Biological|MRKAd5 HIV-1 gag/pol/nef|1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly
12052072|NCT00183261|Biological|MRKAd5 HIV-1 gag/pol/nef placebo|1.0 mL administered intramuscularly
12052073|NCT00183248|Drug|Alemtuzumab|Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4
12052074|NCT00183248|Drug|Mycophenolate mofetil|Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study
12052075|NCT00183248|Drug|Sirolimus|Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study
12052076|NCT00183248|Drug|Tacrolimus|Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study
12052077|NCT00183248|Procedure|Donor bone marrow stem cell infusion|2 doses of kidney donor's bone marrow stem cells by IV infusion on Day 5 and sometime between Months 4 and 6
12052078|NCT00183248|Procedure|Kidney transplant|Occurs at study entry
12052079|NCT00183235|Drug|aripiprazole (up to 15 mg/day) for 8 days|
12052080|NCT00183222|Drug|naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days|
12052081|NCT00183209|Behavioral|Family First|Family First = 14 sessions lasting 1.5 hours each based on Social Action Theory and Motivational Interviewing (7 sessions on reducing alcohol and drug use and 7 sessions on reducing parenting challenges). Brief Video Intervention was a single session designed to increase motivation to reduce/eliminate problem drinking or drug use.
12052082|NCT00183196|Drug|Naltrexone|Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks
12052083|NCT00183196|Drug|Naltrexone plus Gabapentin|naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks
12052084|NCT00183196|Other|Inactive Placebo|Placebo
12052085|NCT00183183|Behavioral|Screening and Brief Intervention|
12052086|NCT00183170|Drug|Alcohol|Participants report for their first dosing night where they receive several alcohol/beer drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. Participants return in a week for the 2nd session and receive placebo drinks. Participants are breath-tested after completing their placebo drinks.
12052087|NCT00183170|Other|Placebo|Participants report for their first night where they receive several placebo drinks. Participants are breath-tested after completing their placebo drinks. Participants return in a week for the 2nd session and receive alcohol drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose.
12052088|NCT00183157|Behavioral|Brief Motivational Intervention|One-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
12052089|NCT00183157|Behavioral|Assessment and list of resources|One-third will receive only the assessment and a list of community resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
12052090|NCT00183157|Behavioral|Referral to Community Resources|All patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. One-third of the enrollees will receive only a list of resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
12052091|NCT00183144|Behavioral|Contingency management|
12052092|NCT00183131|Behavioral|Brief Personalized Feedback|
12052093|NCT00183118|Behavioral|Adapted Enhanced-RESPECT (HIV prevention intervention)|
12052094|NCT00183105|Behavioral|Brief Intervention (adaptation of motivational interviewing)|
12052095|NCT00183092|Drug|Quinacrine|100mg by mouth three times a day
12052096|NCT00183092|Drug|Placebo|100mg by mouth three times a day
12052097|NCT00183079|Behavioral|Motivationally-focused brief alcohol intervention|Brief, motivationally-focused alcohol intervention
12052098|NCT00183053|Device|BedEx Patient Occupancy Monitoring System|
12052099|NCT00183040|Drug|Topical testosterone|
12052100|NCT00183040|Drug|Recombinant human growth hormone|
12052101|NCT00183027|Behavioral|Dietary composition and energy intake|
12052102|NCT00183014|Behavioral|The Lifetime Fitness Program|A series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
12052103|NCT00183014|Behavioral|Exercise class|1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
12052104|NCT00183001|Drug|Vitamin K|
12052105|NCT00182975|Drug|DHEA replacement|
12052106|NCT00182962|Behavioral|Geriatric Resources for Assessment & Care of Elders (GRACE)|
12052107|NCT00182936|Behavioral|Delirium Abatement Program|
12052108|NCT00182897|Behavioral|Skills Building for Caregiver Health and Care-recipient|
12052109|NCT00182884|Drug|Donepezil|
12052110|NCT00182871|Drug|testosterone|
12052111|NCT00182845|Drug|Donepezil|
12052112|NCT00182832|Behavioral|e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)|Cognitive screening plus Computerized Decision Support System: proactive screening program for cognitive impairment combined with computerized review of the electronic medical record
12052113|NCT00182832|Behavioral|Standard Care|Standard care for hospitalized older patients with cognitive impairment
12052114|NCT00182819|Drug|temozolomide|Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
12052115|NCT00182819|Radiation|radiation therapy|50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
12052116|NCT00182806|Drug|gemcitabine hydrochloride|IV over 30 minutes on days 2 and 9. Courses repeat every 21 days.
12052117|NCT00182806|Drug|irinotecan hydrochloride|IV over 90 minutes on days 1 and 8. Courses repeat every 21 days.
12052118|NCT00182793|Biological|trastuzumab|Cycle 1: 6 mg/kg on day -2 from PBSC reinfusion Cycle 2: 6 mg/kg on day -7 from PBSC reinfusion
12052119|NCT00182793|Drug|carboplatin|Cycle 2: 800 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
12052120|NCT00182793|Drug|cyclophosphamide|Cycle 2: 6000 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
12052121|NCT00182793|Drug|melphalan|Cycle 1: 150 mg/m2 on day -1 from PBSC reinfusion
12052122|NCT00182793|Drug|thiotepa|Cycle 2: 500 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
12052123|NCT00182793|Procedure|adjuvant therapy|Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy.
12052124|NCT00182793|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation.
12052125|NCT00182793|Procedure|bone marrow ablation with stem cell support|Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation
12052126|NCT00182793|Radiation|radiation therapy|"After recovery from high-dose chemotherapy and autologous PBSC transplantation; patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Treatment should be delivered daily M-F @ 180-200 cGY/day to a total of 4,500 to 5,040 cGy.
~Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. Treatment should be delivered daily @180-220 cGY/day to a total of 4,000-5,000 cGy."
12052127|NCT00182780|Dietary Supplement|American ginseng|
12052128|NCT00182780|Other|Placebo|
12052129|NCT00182767|Drug|ixabepilone|Given IV
12052130|NCT00182767|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
12052131|NCT00182754|Drug|octreotide acetate|Given subcutaneously
12052132|NCT00182754|Other|placebo|Given subcutaneously
12052133|NCT00182741|Dietary Supplement|calcitriol|
12052134|NCT00182741|Drug|mitoxantrone hydrochloride|
12052135|NCT00182741|Drug|prednisone|
12052136|NCT00182728|Procedure|surgery|conventional
12052137|NCT00182728|Procedure|therapy|neoadjuvant
12052138|NCT00182728|Radiation|radiation therapy|intraoperative radiation therapy
12052139|NCT00182715|Biological|cetuximab|
12052140|NCT00182715|Drug|capecitabine|
12052141|NCT00182715|Drug|fluorouracil|
12052142|NCT00182715|Drug|leucovorin calcium|
12052143|NCT00182715|Drug|oxaliplatin|
12052144|NCT00182702|Drug|ixabepilone|Given IV
12052145|NCT00182702|Other|laboratory biomarker analysis|Correlative studies
12052146|NCT00182689|Drug|sorafenib tosylate|Given orally
12052147|NCT00182663|Drug|clarithromycin|Given PO
12052148|NCT00182663|Drug|thalidomide|Given PO
12052149|NCT00182663|Drug|dexamethasone|Given PO
12052150|NCT00182650|Biological|aldesleukin|
12052151|NCT00182650|Biological|rituximab|
12052152|NCT00182650|Biological|therapeutic autologous lymphocytes|
12052153|NCT00182650|Drug|fludarabine phosphate|
12052154|NCT00182637|Drug|bortezomib|
12052155|NCT00182611|Drug|cisplatin|
12052156|NCT00182611|Drug|tegafur-gimeracil-oteracil potassium|
12052157|NCT00182611|Procedure|adjuvant therapy|
12052158|NCT00182611|Procedure|conventional surgery|
12052159|NCT00182611|Procedure|neoadjuvant therapy|
12052160|NCT00182598|Procedure|computer-based psychoeducational intervention|
12052161|NCT00182598|Procedure|community-based substance abuse counseling|
12052162|NCT00182585|Procedure|computer-based HIV, STD & Hepatitis Education|
12052163|NCT00182585|Procedure|educator-delivered HIV, STD and Hepatitis education|
12052164|NCT00182572|Drug|buprenorphine|
12052165|NCT00182572|Drug|naltrexone|
12052166|NCT00182572|Procedure|behavior therapy|
12052167|NCT00182572|Procedure|voucher-based contingency management|
12052168|NCT00182559|Drug|Ciclosporin|Maintain ciclosporin in combination with/without mycophenolate mofetil and with/without steroids at target trough levels of 70-150ng/mL.
12052169|NCT00182559|Drug|Tacrolimus|Conversion from ciclosporin to tacrolimus at target trough levels of 5-8 ng/mL in combination with/without mycophenolate mofetil and with/without steroids.
12052170|NCT00182546|Procedure|Two diagnostic management strategies|
12052171|NCT00182533|Drug|Sertraline|25 - 200 mg/day x 16 weeks
12052172|NCT00182533|Drug|Placebo|25 - 200 mg/day x 16 weeks
12052173|NCT00182520|Drug|Topiramate|25 mg - 400 mg/day x 12 weeks
12052174|NCT00182520|Drug|placebo|25 - 400 mg/day x 12 weeks
12052175|NCT00182507|Drug|Olanzapine|
12052176|NCT00182494|Behavioral|Modified diabetes prevention protocol & Metformin|
12052177|NCT00182481|Procedure|Induced sputum cell counts|
12052178|NCT00182481|Drug|inhaled corticosteroids and other asthma drugs|
12052179|NCT00182468|Other|Screening for intimate partner violence|Women are screened for intimate partner violence prior to seeing a health care provider.
12052180|NCT00182455|Drug|Topiramate|25 - 400 mg/day x 12 weeks
12052181|NCT00182455|Drug|Placebo|25 - 400 mg/day x 12 weeks
12052182|NCT00182442|Drug|Olanzapine & Quetiapine|
12052183|NCT00182429|Drug|Metronidazole and Rifampin|
12052184|NCT00182416|Device|pacemaker|
12052185|NCT00182403|Drug|UFH 250 U/kg or LMWH 100 U/kg sc twice daily|
12052186|NCT00182390|Procedure|Red blood cell transfusion|
12052187|NCT00182377|Drug|Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)|
12052188|NCT00182364|Drug|Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)|
12052189|NCT00182351|Procedure|D-dimer|
12052190|NCT00182351|Procedure|Serial Compression Ultrasound|
12052191|NCT00182325|Behavioral|personalized web prenatal information|
12052192|NCT00182325|Behavioral|general web prenatal information|
12052193|NCT00182312|Drug|Caffeine citrate injection|"Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection.
~Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established.
~Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy."
12052194|NCT00182299|Procedure|porcine small intestine submucosa (SIS)|
12052195|NCT00182286|Behavioral|Assessment of continuity of care from the patient perspective|
12052196|NCT00182286|Behavioral|Relationship between continuity of care, patient outcomes, and costs|
12052197|NCT00182273|Procedure|Canalith repositioning maneuver (CRM)|
12052198|NCT00182260|Drug|Proton Pump Inhibitors|
12052199|NCT00182260|Procedure|Laparoscopic Nissen Fundoplication|
12052200|NCT00182247|Procedure|venogram|
12052201|NCT00182234|Behavioral|Community Interlink Program|The study intervention is a referral to a specialized oncology nursing program. The standardized care provided by this program includes comprehensive assessment and care planning specific to breast and colorectal cancers during the initial phases of treatment, with a minimum of two home visits. Through consultation with the patient, nurses either provide direct (non-medical) care to address needs identified and/or coordinate linkage to services in the community.
12052202|NCT00182221|Procedure|MDA D-Dimer Testing|
12052203|NCT00182208|Device|Veno-device (Venowave)|
12052204|NCT00182195|Procedure|Control Ventilation Strategy|
12052205|NCT00182182|Behavioral|Primary care based disease management strategy|
12052206|NCT00182169|Drug|Human recombinant growth hormone|
12052207|NCT00182143|Drug|LMWH (Fragmin, dalteparin)|Placebo AM dose (normal saline) and LMWH (Fragmin, dalteparin) 5000IU PM dose
12052208|NCT00182143|Drug|Unfractionated Heparin|5000 IU BID
12052209|NCT00182130|Procedure|Quality Initiative in Rectal Cancer (QIRC) strategy|
12052210|NCT00182104|Drug|Warfarin vs ASA|
12052211|NCT00182091|Drug|Recombinant human growth hormone|Starting dose based on age, sex, and estrogen status and ranged from 3-6 mcg/kg/day. GH doses were adjusted based on IGF-1 levels to target the mid-normal range for age.
12052212|NCT00182091|Drug|Saline|To maintain study-subject blinding, doses were sham adjusted.
12052213|NCT00182078|Drug|Placebo|The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
12052214|NCT00182078|Drug|Sertraline|The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
12052215|NCT00182052|Drug|Rosiglitazone|Given orally twice daily. Participants may continue study treatment as long as their disease does not progress and they don't experience any serious side effects.
12052216|NCT00182052|Other|Placebo|Given orally twice daily.
12052217|NCT00182039|Drug|Metoprolol controlled release (CR)|Patients received the first dose of the study drug (i.e., oral metoprolol CR or matching placebo 100 mg) 2-4 hours prior to surgery. Administration of the study drug at each dosing time required a patient to have a heart rate ≥ 50 beats per minute (bpm) and a systolic blood pressure (SBP) ≥ 100 mmHg. If the patient's heart rate was ≥ 80 bpm and their SBP ≥ 100 mmHg at any time during the first 6 hours after surgery, the patient received their first postoperative dose (i.e., 100 mg of the study drug) orally. Patients who did not receive the study drug during the first 6 hours after surgery received 100 mg of the study drug orally at 6 hours after surgery. Twelve hours after the first postoperative dose patients started taking oral metoprolol CR or placebo 200 mg daily for 30 days.
12052283|NCT00181194|Device|Asthma Control and Communication Instrument|
12052284|NCT00181181|Drug|atorvastatin|Atorvastatin 80 mg daily for 3 months
12052285|NCT00181181|Other|placebo|placebo daily
12052286|NCT00181168|Drug|Euthyroid Group|Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
12052287|NCT00181155|Drug|Allopurinol|intravenous infusion of allopurinol (300mg)
12052218|NCT00182039|Drug|Placebo|Patients received the first dose of the study drug (i.e., oral metoprolol CR or matching placebo 100 mg) 2-4 hours prior to surgery. Administration of the study drug at each dosing time required a patient to have a heart rate ≥ 50 beats per minute (bpm) and a systolic blood pressure (SBP) ≥ 100 mmHg. If the patient's heart rate was ≥ 80 bpm and their SBP ≥ 100 mmHg at any time during the first 6 hours after surgery, the patient received their first postoperative dose (i.e., 100 mg of the study drug) orally. Patients who did not receive the study drug during the first 6 hours after surgery received 100 mg of the study drug orally at 6 hours after surgery. Twelve hours after the first postoperative dose patients started taking oral metoprolol CR or placebo 200 mg daily for 30 days.
12052219|NCT00182026|Behavioral|personal feedback report|A computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire.
12052220|NCT00182013|Drug|Risperidone|Open treatment with Risperidone
12052221|NCT00182013|Drug|Olanzapine|Open treatment with Olanzapine
12052222|NCT00182013|Drug|Quetiapine|Open treatment with Quetiapine
12052223|NCT00182000|Drug|seromycin|100mg tablet administered 1 hour prior to each therapy session
12052224|NCT00182000|Behavioral|Behavior Therapy|10 weekly hour-long behavior therapy sessions
12052225|NCT00181987|Drug|methylphenidate HCl (Concerta)|
12052226|NCT00181974|Drug|Tisseel Fibrin Sealant|
12052227|NCT00181961|Drug|Maca Root|
12052228|NCT00181948|Drug|atomoxetine (Strattera)|
12052229|NCT00181935|Drug|risperidone (Risperdal)|
12052230|NCT00181935|Drug|olanzapine (Zyprexa)|
12052231|NCT00181922|Drug|ziprasidone (Geodon)|
12052232|NCT00181909|Behavioral|Smoking cessation counseling delivered by telephone|
12052233|NCT00181896|Drug|bupropion SR|Open-label prescription of Bupropion SR for 8 weeks.
12052234|NCT00181883|Drug|quetiapine|2.5 - 5.0mg/kg PO BID quetiapine
12052235|NCT00181870|Drug|carbamazepine ER (Equetro)|
12052236|NCT00181844|Drug|lamotrigine|Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children <12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.
12052237|NCT00181831|Device|Proton Magnetic Resonance Spectroscopy|
12052238|NCT00181818|Drug|bupropion SR (sustained-release)|
12052239|NCT00181779|Drug|aripiprazole (Abilify)|
12052240|NCT00181766|Drug|Strattera (atomoxetine)|Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
12052241|NCT00181753|Drug|standard vs. glutamine enteral or parenteral feeding.|Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
12052242|NCT00181753|Dietary Supplement|Stable isotope tracer study|7 hours of primed constant infusion
12052243|NCT00181753|Dietary Supplement|Stable isotope study|7 hours of primed constant infusion of stable isotope tracers.
12052244|NCT00181753|Dietary Supplement|Stable isotope tracer study|7 hours of primed constant stable isotope tracer infusion.
12052245|NCT00181753|Dietary Supplement|Stable isotope tracer study|7 hours primed constant infusion of stable isotope tracer study
12052246|NCT00181740|Drug|atomoxetine (Strattera)|
12052247|NCT00181727|Drug|divalproex sodium extended release|
12052248|NCT00181714|Drug|methylphenidate HCl (Concerta)|OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.
12052249|NCT00181701|Drug|Paclitaxel|
12052250|NCT00181701|Drug|Carboplatin|
12052251|NCT00181688|Drug|Iressa (ZD1839)|
12052252|NCT00181688|Drug|Arimidex (Anastrozole)|
12052253|NCT00181675|Drug|galantamine HBr|
12052254|NCT00181662|Drug|Curcumin|
12052255|NCT00181649|Drug|Recombinant human prolactin|
12052256|NCT00181636|Drug|Galantamine-CR|
12052257|NCT00181623|Drug|Recombinant Human Prolactin|
12052258|NCT00181610|Drug|Recombinant Human Prolactin|60 mcg/kg every 12 hours
12052259|NCT00181610|Biological|Recombinant human prolactin|60 mcg/kg given every 12 hours or every 24 hours
12052260|NCT00181610|Biological|Normal Saline|twice per day
12052261|NCT00181597|Drug|Trilostane|Taken orally once a day for three days then twice daily thereafter.
12052262|NCT00181597|Drug|Hydrocortisone|Taken orally with trilostane.
12052263|NCT00181584|Drug|Zoledronic acid|Given intravenously once.
12052264|NCT00181584|Other|Placebo|Given intravenously once.
12052265|NCT00181571|Drug|methylphenidate HCl (Concerta)|up to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight.
12052266|NCT00181571|Drug|Placebo|up to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight.
12052267|NCT00181558|Drug|Atrasentan|
12052268|NCT00181558|Drug|Zoledronic Acid (Zometa)|
12052269|NCT00181545|Procedure|escalation of dose (radiotherapy treatment)|
12052270|NCT00181532|Drug|Celecoxib|
12052271|NCT00181506|Procedure|dose escalation (radiotherapy treatment schedule)|
12052272|NCT00181363|Device|Mamma board|use of mamma board during radiotherapy
12052273|NCT00181350|Device|Relocatable fixation system|
12052274|NCT00181311|Procedure|hysterectomy|
12052275|NCT00181298|Drug|Memantine|Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4.
12052276|NCT00181298|Drug|Placebo|Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4
12052277|NCT00181285|Device|High Frequency Chest Wall Oscillator|High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax
12052278|NCT00181272|Drug|azithromycin|
12052279|NCT00181246|Drug|Transdermal Fentanyl|
12052280|NCT00181220|Drug|valproic acid|
12052281|NCT00181207|Device|pneumatic vest|
12052282|NCT00181207|Other|placebo pneumatic vest|
12052288|NCT00181155|Drug|Placebo|intravenous infusion of 50 ml dose of 5% dextrose
12052289|NCT00181142|Drug|Zenapax|
12052290|NCT00181129|Behavioral|home based self paced walking program|
12052291|NCT00181116|Drug|Levetiracetam|
12052292|NCT00181090|Behavioral|Modified Atkins diet|
12052293|NCT00181077|Drug|2% buffered hypertonic saline administration|
12052294|NCT00181064|Behavioral|Modified Atkins diet|15 grams of carbohydrates per day - high fat diet
12052295|NCT00181051|Device|Alaris AEP monitor|
12052296|NCT00181038|Device|Peri-Neuronal Catheter|
12052297|NCT00181025|Drug|Tasonermine (TNFa)|
12052298|NCT00181025|Drug|Melphalan|
12052299|NCT00181012|Drug|Lidocaine|
12052300|NCT00180999|Drug|Erythropoiétine|
12052301|NCT00180986|Procedure|Platelet concentrates|
12052302|NCT00180973|Drug|Hydroxyurea|
12052303|NCT00180960|Drug|Oxaliplatin and irinotecan|
12052304|NCT00180947|Drug|Vinorelbine, cyclofosfamide|
12052305|NCT00180934|Procedure|Reirradiation with concomitant chemotherapy|
12052306|NCT00180921|Drug|Imatinib|
12052307|NCT00180908|Drug|Etoposide, Ifosfamide, Methotrexate|
12052308|NCT00180908|Drug|Doxorubicin, Methotrexate|
12052309|NCT00180895|Drug|Rituximab|
12052310|NCT00180882|Drug|rituximab|
12052311|NCT00180869|Procedure|transfusion of allogeneic red blood cell concentrate|
12052312|NCT00180869|Procedure|transfusion of leuko-reduced red blood cell concentrate|
12052313|NCT00180856|Procedure|Radiofrequency ablation|
12052314|NCT00180843|Drug|salbutamol + ipratropium bromide nebules|
12052315|NCT00180843|Drug|nebulized saline|
12052316|NCT00180830|Drug|Glivec|
12052317|NCT00180830|Drug|Gleevec|
12052318|NCT00180791|Drug|Etoposide, carboplatin, melphalan, cisplatin, thiotepa|
12052319|NCT00180778|Drug|Low dose steroids|
12052320|NCT00180765|Procedure|Up to 100ml blood will be taken by venupuncture.|
12052321|NCT00180739|Procedure|Magnetic Resonance Guided Focused Ultrasound|
12052322|NCT00180726|Procedure|Blood sampling, Endoscopic Bronchoscopy, Spirometry|
12052323|NCT00180713|Drug|Simvastatin|Simvastatin 40mg od for 1 month, then 80mg od for 11 months
12052324|NCT00180713|Drug|Placebo|Placebo tablet once daily.
12052325|NCT00180700|Behavioral|Hypnosis|
12052326|NCT00180687|Drug|Nebulised Bupivacaine intraperitoneally|Nebulised Marcaine (Bupivacaine)
12052327|NCT00180687|Drug|Normal Saline|Nebulised Normal Saline
12052328|NCT00180687|Drug|Injected Bupivacaine intraperitoneally|Injected Marcaine directly into the peritoneal cavity
12052329|NCT00180687|Other|No Intraperitoneal Therapeutics|No Intraperitoneal Therapeutics given
12052330|NCT00180674|Drug|Warfarin|
12052331|NCT00180635|Drug|Aminoguanidine|500mg
12052332|NCT00180635|Drug|Placebos|2ml
12052333|NCT00180622|Procedure|Spirometry|
12052334|NCT00180622|Procedure|Exhaled Nitric Oxide and Carbon Monoxide|
12052335|NCT00180622|Procedure|Exhaled Breath Condensate|
12052336|NCT00180622|Procedure|Induced Sputum|
12052337|NCT00180622|Procedure|CT Scan|
12052338|NCT00180622|Procedure|Blood test|
12052339|NCT00180622|Procedure|St Georges Questionnaire|
12052340|NCT00180622|Procedure|Bodypletysmography|
12052341|NCT00180609|Device|Automatic threshold test in Insignia Pacemakers from Guidant|
12052342|NCT00180596|Device|Contak heart failure devices|
12052343|NCT00180583|Device|Guidant GALILEO Intravascular Radiotherapy System|Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
12052344|NCT00180570|Device|FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ|
12052345|NCT00180557|Device|Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip|
12052346|NCT00180544|Device|Stenting: Renal Artery|Male and female patients, who meet study eligibility criteria, agree to participate in the trial, and sign an informed consent, will be enrolled in the study. A HERCULINK™ 14 Peripheral Stent will be used in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) atherosclerotic renal artery stenoses.
12052347|NCT00180531|Device|Renewal TR2|
12052348|NCT00180518|Device|Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection system|"Two rapid exchange devices will be evaluated: the RX ACCUNET Embolic Protection System (RX ACCUNET) and the RX ACCULINK Carotid Stent System (RX ACCULINK).
~The RX ACCUNET Embolic Protection System is intended to facilitate the placement of diagnostic and therapeutic devices during interventional procedures and to capture embolic material that may be present during carotid artery interventional procedures.
~The RX ACCULINK™ Carotid Stent System is intended for the treatment of carotid artery stenosis in the internal carotid artery (ICA), with or without involvement of the contiguous common carotid artery (CCA), in asymptomatic patients and symptomatic patients."
12052349|NCT00180505|Device|ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent|A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.
12052350|NCT00180492|Device|RX ACCULINK(TM) Carotid Stent System and RX ACCUNET(TM) Embolic Protection System|
12052351|NCT00180479|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12052352|NCT00180479|Device|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12052353|NCT00180453|Device|Coronary artery drug eluting stent placement|Coronary artery drug eluting stent placement
12052354|NCT00180453|Device|Coronary artery stent placement|Coronary artery stent placement
12052355|NCT00180440|Device|ICD|all models of Guidant/Bsc ICD's
12052356|NCT00180427|Device|ICD|
12052357|NCT00180414|Device|CRT devices with ventricular rate regulation [VRR] (CE labeled)|
12052358|NCT00180401|Behavioral|CRT-P and CRT-D devices|
12052359|NCT00180388|Procedure|endoscopic vein harvesting|
12052360|NCT00180388|Procedure|open vein harvesting|
12052361|NCT00180375|Device|Prizm, Vitality, Renewal|Follow-up during 2 years
12052362|NCT00180362|Device|procedure|
12052363|NCT00180349|Device|Endotak Reliance|Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed.
12052364|NCT00180336|Device|CRT-D|
12052365|NCT00180323|Device|Renewal|Renewal is a CRT-D device for cardiac resynchronization therapy
12052366|NCT00180310|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12052367|NCT00180310|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease
12052368|NCT00180297|Device|Endotak Reliance G|Reliance G is a defibrillation lead to be placed in the right ventricle.
12052369|NCT00180284|Device|SITELINE 2 Polyurethane (pacing lead)|SITELINE 2 Polyurethane (pacing lead)
12052370|NCT00180271|Device|Cardiac resynchronization therapy with defibrillation|Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
12052371|NCT00180271|Device|Implantable Cardioverter Defibrillator (ICD)|Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator
12052372|NCT00180258|Device|Cardiac Resynchronization Therapy with & without defibrillator|
12052373|NCT00180206|Device|Birmingham Hip Resurfacing|
12052374|NCT00180167|Drug|randomization between two established Chemotherapies|
12052375|NCT00180141|Drug|Elidel-Creme|
12052376|NCT00180128|Drug|all-trans retinoid acid|
12052377|NCT00180128|Drug|idarubicin|
12052378|NCT00180128|Drug|mitoxantrone|
12052379|NCT00180128|Drug|daunorubicin|
12052380|NCT00180128|Drug|cytarabine|
12052381|NCT00180115|Drug|Cytarabine Dosage|
12052382|NCT00180102|Drug|Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone|
12052383|NCT00180102|Procedure|early allogeneic PBSCT within induction therapy|
12052384|NCT00180102|Procedure|autologous PBSCT|
12052385|NCT00180089|Drug|Budesonide|
12052386|NCT00180076|Drug|Budesonide|
12052387|NCT00180063|Drug|L-NMMA(drug)|
12052388|NCT00180050|Drug|Budesonide|
12052389|NCT00180037|Drug|Coenzyme Q10 Nanodispersion (Nanoquinone)|
12052390|NCT00180037|Drug|Placebo|
12052391|NCT00180024|Drug|irbesartan (drug)|
12052392|NCT00180011|Drug|Omalizumab|injectable medication
12052393|NCT00179998|Drug|Recombinant Human DNase (Pulmozyme)|2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months
12052394|NCT00179998|Drug|Placebos|2.5 ml sterile solution (8.77 mg/ml sodium chloride, 0.15 mg/ml calcium chloride, pH 7.0 +/- 2.0) delivered daily by nebulization for 6 months, either preceding or following 6 months of Pulmozyme depending on randomization of the subject
12052395|NCT00179972|Device|Adhesive and non-adhesive oximetry sensors|A sample of 32 premature infants will be recruited to participate in this study in which an adhesive sensor and a nonadhesive sensor are compared. Both sensors will be simultaneously tested in each subject, for a period of 14 days, with one sensor on the right foot and the other sensor on the left foot. Data will be collected on sensor longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use rating by the clinician. Data will be summarized using descriptive statistics.
12052396|NCT00179959|Drug|Sodium hypochlorite (bleach) baths|Sodium hypochlorite (bleach) baths twice weekly for 3 months
12052397|NCT00179959|Drug|Mupirocin ointment|Intranasal mupirocin 2% ointment BID x five days (3 times total for subjects; one time only for family members)
12052398|NCT00179959|Drug|Water|Water baths twice weekly for three months
12052399|NCT00179959|Drug|Petrolatum Ointment|Intranasal petrolatum ointment twice daily for five days
12052400|NCT00179946|Procedure|HLA typing|
12052401|NCT00179933|Behavioral|Newborn Individualized Assessment Program|
12052402|NCT00179920|Drug|Carboplatin|
12052403|NCT00179920|Drug|VP-16|
12052404|NCT00179920|Procedure|Local Surgery|
12052405|NCT00179920|Procedure|Cryotherapy|
12052406|NCT00179920|Procedure|Laser hyperthermia|
12052407|NCT00179907|Procedure|Photon Radiosurgery System (Intrabeam)|In this study we had intended to perform a similar dose escalation study with doses ranging from 10-19 Gy, 10-16 Gy and 10 - 14 Gy for tumors < 20 mm, 21-25 mm and 26-40 mm respectively
12052408|NCT00179894|Behavioral|Physician training|Physicians are trained in guidelines for medication management.
12052409|NCT00179881|Drug|Carboplatin|
12052410|NCT00179881|Drug|Thalomid|
12052411|NCT00179881|Procedure|External Beam Radiation Therapy|
12052412|NCT00179868|Behavioral|C-Reactive Protein levels|"Each patient enrolled in the study will have a serum quantitative c-reactive protein (crp) level drawn on the day of transplant, day 7 of transplant, and twice weekly after that until recovery of neutrophil count (approximately 20-25 days). Patients will be followed for 100 days post-transplant for the development of the following complications:
~Sepsis- defined as fever, positive blood culture, need for fluid resuscitation and/or pressor support.
~Acute GVHD > grade II defined according to the Seattle criteria
~VOD- defined according to the modified Seattle criteria"
12052413|NCT00179855|Procedure|Extracorporeal Photopheresis|"ECP will be performed using the UVAR® XTS™ photopheresis system (Therakos). Whole blood is drawn and separated by centrifuge to collect the buffy coat (lymphocyte solution). Methoxsalen (8-MOP) is added to the blood, and the final solution of cells is passed as a film, 1mm thick, through a disposable plastic device, exposed to a UVA light source (2J/cm2/cell) and then returned to the patient.
~ECP will be performed weekly on 2 consecutive days for 4 weeks. After 4 weeks the interval will be prolonged to every 2 weeks and ECP will be stopped after maximal response has been maintained for 2 weeks. The actual study finishes at d56 but ECP may be continued beyond that (off-study) at the discretion of the physician."
12052414|NCT00179842|Procedure|Stem Cell Transplant|
12052415|NCT00179829|Procedure|WT 1 Testing|
12052479|NCT00179218|Drug|nutritional supplementation|oral administration of 2 cans of protein supplement (lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat); every other day, 3 days per week, for 6 months
12052416|NCT00179816|Drug|High-Dose Chemotherapy with Tandem PBSC Rescue.|Patients on this study will undergo a tandem Peripheral Blood Stem Cell Rescue following high-dose chemotherapy. The first Peripheral Blood Stem Cell Rescue will consist of Etoposide, Carboplatin, Cyclophosphamide, and Mesna. Once the patient recovers, the patient will be evaluated again and will then undergo a second stem cell transplant consisting of the chemotherapy drugs; Melphalan, Cyclophosphamide, and Mesna.
12052417|NCT00179803|Procedure|Stem Cell Transplant|"Group A: recurrent medulloblastoma, recurrent germ cell tumor
~Cytoxan treatment
~Stem cell autologous harvest
~Group B: GBM, high grade astrocytoma, rhabdoid tumors, pineoblastoma, or supratentorial PNET
~Carboplatin and Etoposide treatment
~Autologous stem cell harvest
~The preparatory regimen used for Stem Cell Rescue #1 will be Carboplatinum, VP-16 and Thiotepa. If the patient has recuperated his ANC to >1,000 within 50 days after Stem Cell Rescue #1, (sustained without G-CSF support) a neuroradiographic evaluation will be performed. If there is lack of progression, the patient will then proceed to Stem Cell Rescue # 2 with Cyclophosphamide and Melphalan, followed by stem cell rescue."
12052418|NCT00179790|Procedure|Extracorporeal Photopheresis|Patient will undergo ECP treatment pre and post stem cell transplant infusion
12052419|NCT00179777|Dietary Supplement|hydrolysed infant formula|hydrolysed infant formula
12052420|NCT00179777|Dietary Supplement|nonhydrolysed infant formula|nonhydrolysed infant formula
12052421|NCT00179764|Procedure|Immunoablative Hematopoietic PBSC Transplant|Immunoablative conditioning chemotherapy regimen, followed by transplantation of peripheral blood stem cells on Day 0 of the conditioning regimen.
12052422|NCT00179764|Procedure|Busulfan pharmacokinetics|Pharmacokinetics of once-a-day dosing of intravenous busulfan as a 3-hour infusion
12052423|NCT00179764|Radiation|Central Nervous System (CNS) prophylaxis radiation|"Patients diagnosed with ALL over 1 year of age and without prior CNS disease will receive CNS prophylaxis radiation to the whole brain prior to transplant.
~Patients diagnosed with ALL with prior CNS disease over the age of 1 year will be treated with prophylaxis radiation to the whole brain and spine prior to transplant."
12052424|NCT00179751|Drug|CC-5013|
12052425|NCT00179751|Drug|gemcitabine|
12052426|NCT00179738|Drug|CC5013|
12052427|NCT00179725|Drug|CC-5013|
12052428|NCT00179725|Drug|liposomal doxorubicin|
12052429|NCT00179712|Drug|CC-5013|
12052430|NCT00179712|Drug|topotecan|
12052431|NCT00179699|Drug|CC-5013|
12052432|NCT00179699|Drug|pemetrexed|
12052433|NCT00179686|Drug|CC-5013|
12052434|NCT00179673|Drug|Lenalidomide|Lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed
12052435|NCT00179660|Drug|Lenalidomide|Capsules for oral administration.
12052436|NCT00179647|Drug|lenalidomide|Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone
12052437|NCT00179647|Drug|dexamethasone|Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens
12052438|NCT00179634|Behavioral|Visualization relaxation|
12052439|NCT00179634|Behavioral|Visual Milieu Enhancement (Fine art photograph)|
12052440|NCT00179621|Drug|Lenalidomide 5 mg|Lenalidomide 5 mg daily 28/28 days
12052441|NCT00179621|Drug|Lenalidomide 10 mg|Lenalidomide 10 mg daily 21/28 days
12052442|NCT00179621|Drug|Placebo|Placebo, matching to active study drug arms
12052443|NCT00179608|Drug|CC-5013|
12052444|NCT00179595|Behavioral|relaxation response- meditation|
12052445|NCT00179582|Drug|VSL#3|
12052446|NCT00179569|Behavioral|Relaxation response|8 weeks of relaxation response training
12052447|NCT00179556|Drug|Isoflavone supplement|
12052448|NCT00179543|Behavioral|Relaxation response|
12052449|NCT00179530|Behavioral|Relaxation Response|Relaxation training
12052450|NCT00179517|Drug|Anastrozole 1mg|
12052451|NCT00179517|Drug|Placebo Oral Tablet|
12052452|NCT00179504|Behavioral|Relaxation Response|Relaxation training
12052453|NCT00179491|Behavioral|Intercessory Prayer|14 days of intercessory prayer from 3 sites
12052454|NCT00179478|Drug|interferon beta 1a 30 ug IM once weekly|Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.
12052455|NCT00179465|Drug|Tiagabine|Up to 36 mg daily
12052456|NCT00179465|Drug|Placebo|Placebo
12052457|NCT00179452|Behavioral|Yoga|
12052458|NCT00179439|Procedure|nasal potential difference testing|
12052459|NCT00179413|Drug|PEG -Intron|
12052460|NCT00179413|Drug|Colchicine|0.6mg twice a day
12052461|NCT00179400|Drug|Pioglitazone 45 mg|
12052462|NCT00179400|Drug|Placebo|
12052463|NCT00179387|Behavioral|Mind-Body Psychotherapy Group|Psycho-educational group
12052464|NCT00179387|Behavioral|Mind-Body Psychotherapy Group|Spiritual-Existential Group
12052465|NCT00179374|Behavioral|Tailored telephone intervention of education|Tailored telephone intervention to promote metabolic control of diabetes
12052466|NCT00179374|Behavioral|Print educational intervention|diabetes educational materials by mail
12052467|NCT00179348|Procedure|Quality-of-Life Assessment|Ancillary studies
12052468|NCT00179348|Procedure|Yoga|Undergo a yoga-based rehabilitation program
12052469|NCT00179335|Procedure|Blood drawing to determine drug levels|
12052470|NCT00179309|Drug|Docetaxel|35 mg/m^2 intravenous 30-60 minutes once a week for 3 consecutive weeks with 1 week off drug.
12052471|NCT00179309|Biological|PANVAC-V|2 x 10^8 PFU
12052472|NCT00179309|Biological|PANVAC-F|1 x 10^9 PFU
12052473|NCT00179309|Biological|Sargramostim|Given subcutaneously under the skin, usually in the thigh on the day of vaccination and daily for the next 3 days.
12052474|NCT00179283|Drug|sertraline|
12052475|NCT00179283|Drug|venlafaxine XR|
12052476|NCT00179257|Drug|sertraline (Zoloft)|
12052477|NCT00179244|Drug|Rispridone (drug) and Bupropion ER (drug)|
12052478|NCT00179231|Drug|olanzapine vs. clozapine|
12052480|NCT00179218|Behavioral|exercise|leg press exercise; every other day, 3 days per week, for 6 months
12052481|NCT00179205|Drug|Nepro nutritional supplement|oral nutritional supplement (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 480 calories: 71 calories from protein, 206 calories from carbohydrates and 206 calories from fat.
12052482|NCT00179205|Drug|placebo|oral placebo (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 60 calories: 0 calories from protein, 60 calories from carbohydrates, and 0 calories from fat.
12052483|NCT00179192|Procedure|angioplasty|angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
12052484|NCT00179192|Procedure|surgery|surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure
12052485|NCT00179179|Drug|nutritional supplementation|2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period
12052486|NCT00179179|Behavioral|exercise|resistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period
12052487|NCT00179166|Drug|TPN nutritional supplement|intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)
12052488|NCT00179153|Dietary Supplement|Nepro nutritional supplement|oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months
12052489|NCT00179140|Drug|nutritional supplementation|oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat
12052490|NCT00179140|Behavioral|exercise|either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months
12052491|NCT00179127|Drug|glargine|0.3u/kg of glargine, subcutaneously, once
12052492|NCT00179127|Drug|saline|0.3u/kg of saline, subcutaneously, once
12052493|NCT00179114|Drug|Botulinum Toxin Type A|
12052494|NCT00179114|Drug|Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)|
12052495|NCT00179101|Procedure|Deep Brain Stimulation|
12052496|NCT00179088|Behavioral|Patient may be able to put weight on the operated leg|
12052497|NCT00179062|Drug|olanzapine versus risperidone|Participants are to be randomized to olanzapine or risperidone. Antipsychotic medication will be given as per package insert daily for the twelve month duration of the trial.
12052498|NCT00179023|Drug|Trimethaphan|Start dose: 0.05 ml/min (0.5 mg/min), IV infusion. The dose will be increased every 2-4 minutes to 1, 2, 4, and 5 mg/min. Total duration: 1 hour
12052499|NCT00179023|Drug|Trimethaphan|Start dose: 0.05 ml/min (0.5 mg/min), IV infusion. The dose will be increased every 30 minutes to 1, 2, 4, and 5 mg/min. Total duration: 1-2 hours
12052500|NCT00179023|Drug|Pseudoephedrine|30mg tablet,VO. Single dose.
12052501|NCT00179010|Drug|Adenosine|Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
12052502|NCT00179010|Drug|Adenosine Mono Phosphate (AMP)|Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
12052503|NCT00178971|Drug|adjunctive treatment with buspirone|buspirone 15-30 mg qd
12052504|NCT00178971|Drug|placebo|placebo
12052505|NCT00178958|Device|Holter Monitor|
12052506|NCT00178945|Drug|Botulinum Toxin Type A|
12052507|NCT00178932|Procedure|genetic analysis|genetic assay of blood sample drawn with patient's consent
12052508|NCT00178932|Procedure|genetic assay|genetic assay of blood sample drawn with patient's consent
12052509|NCT00178919|Drug|L-NMMA|IV infusion of 125, 250 and 500 mcg/Kg/min for 15 minutes each dose. The main outcome is the maximal increase in blood pressure produced at the end of the infusions or a maximal systolic blood pressure of 160 mm Hg. It could be achieved after the first dose or the third.
12052510|NCT00178919|Drug|Trimethaphan|IV infusion for the duration of the study at 4-6 mg/min depending on autonomic blockade. This is only to produce transient pharmacological blockade of the autonomic nervous system in order to allow the full expression of the inhibition of nitric oxide synthase. There is no direct outcome associated with this intervention.
12052511|NCT00178854|Drug|Risperidone|
12052512|NCT00178841|Drug|Rosiglitazone and Bexarotene|rosiglitazone added to bexarotene capsules
12052513|NCT00178828|Drug|sertraline|Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
12052514|NCT00178828|Drug|bupropion|Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
12052515|NCT00178802|Other|thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)|"5-fluorouracil 400 mg/m2 i.v. over 24 hours for 5 days
~Doxil (liposomal doxorubicin) 40 mg/m2 over 1 hour
~Fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration daily
~Low-dose interferon-alpha 100,000 i.u. s.c. daily for the duration of the protocol"
12052516|NCT00178776|Behavioral|Transtheoretical Model Group Therapy|
12052517|NCT00178776|Behavioral|Education & Advice|
12052518|NCT00178763|Device|Heckel Infrared Radiant Heat Device|thermotherapy, maintain a core temperature of 40 degrees centigrade for 6 hours duration
12052519|NCT00178763|Other|cisplatin, gemcitabine, interferon-alpha|cisplatin 60 mg/m2 administered over 3 hours intravenously 36 hours before heat. gemcitabine 600 mg/m2 administered intravenously over 1 hour during 40 degree heat. interferon-alpha 1 million international units subcutaneously daily during protocol.
12052520|NCT00178763|Other|thermochemotherapy|fever-range whole-body thermal therapy to 40 degrees centigrade combined with cisplatin 60 mg/m2 + gemcitabine 600 mg/m2 + daily interferon alpha 1 million units.
12052521|NCT00178750|Device|18G Tuohy epidural needle|
12052522|NCT00178750|Device|CompuFlo® computerized syringe pump|
12052523|NCT00178737|Behavioral|Electronic reminder message|
12052524|NCT00178724|Other|No Treatment Given|Intervention is not given.
12052525|NCT00178711|Device|Hypothermia|Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours
12052526|NCT00178698|Other|thermochemotherapy|cisplatin 60 mg/m2 i.v. over 4 hours on day 1 gemcitabine 600 mg/m2 i.v. over 60 minutes on day 3 interferon-alpha 1 million international units s.c. daily for protocol duration
12052527|NCT00178698|Drug|Cisplatin, Gemcitabine, Interferon-a|cisplatin 60 mg/m2 i.v. over 4 hours gemcitabine 600 mg/m2 i.v. over 1 hour interferon-alpha 100,000 i.u. s.c.daily fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration
12052528|NCT00178698|Other|thermochemotherapy|After hydration and anti-emetics, cisplatin 60 mg/m2 i.v. is given over 4 hours on day 1. Also on day 1, begin daily low-dose interferon-alpha 1 million international units s.c. On day 3, 36 hours after cisplatin infusion, induce fever-range whole-body thermal therapy to 40 oC (104 oF) for a duration of 6 hrs. When the target temperature of 40 oC is reached, gemcitabine 600 mg/m2 is administered i.v. over 60 minutes, and the temperature is maintained at plateau for a total of 6 hours. The cycle is repeated at 21 to 28 day intervals.
12052529|NCT00178685|Behavioral|Self-determination Intervention for Tobacco Dependence|autonomy supported behavioral intervention for tobacco dependent individuals
12052530|NCT00178672|Device|Angioguard XP distal protection device|Standard of care stenting of carotid arteries protocol is used.
12052531|NCT00178672|Procedure|Heart Catheterization -Angioplasty|Standard of care carotid stenting. A catheter is inserted in the femoral vein into the carotid artery where a balloon is inflated and shortly thereafter a stent is placed in the target lesion area.
12052532|NCT00178672|Device|stenting|stenting of carotid arteries
12052533|NCT00178659|Other|Blood/saliva samples for protein/molecular analysis|Bloods samples - healthy volunteers(1 time) head injury subjects (5 times). Blood and/or saliva samples mild TBI patients (2 times) and healthy volunteers (2 times)
12052534|NCT00178646|Drug|Botox|Botox 75-150 units, single treatment only
12052535|NCT00178633|Procedure|Bariatric surgery|Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.
12052536|NCT00178620|Drug|Retavase 10 U IV Bolus|Retavase IV Bolus, 10 U, one dose at time of myocardial infarction
12052537|NCT00178620|Procedure|Angioplasty/Heart Catheterization|"Candidates will receive all the approved standard therapy for heart attacks patients and will go directly for emergent heart catheterization.
~Following local anesthesia, a small flexible tube (catheter) will be inserted in an artery of your leg and advanced to the arteries of your heart. By injecting x-ray contrast through the catheter, any blockage in the artery can be seen. If your heart attack artery is still blocked by blood clot or cholesterol deposits, it will be opened up by angioplasty (balloon surgery procedure to open the blocked artery) and stenting (placement of a slotted metal tube in the artery to prevent it from closing on itself)."
12052538|NCT00178620|Device|Drug eluting stent placed in heart attack related artery|Stents will be placed (if needed) during the end of the angioplasty/heart catheterization.
12052539|NCT00178581|Drug|Glutamine|
12052540|NCT00178568|Behavioral|Stress Management and Healthy Sleep Practices|Eight weekly sessions of 1 hour each reviewing stress management techniques and tips for improving sleep.
12052541|NCT00178555|Device|DCI Video Intubation System-Macintosh Laryngoscope|
12052542|NCT00178555|Device|Macintosh Laryngoscope|
12052543|NCT00178529|Behavioral|Psychoeducation, Counseling and Skill Training|
12052544|NCT00178516|Other|behavior, procedure|
12052545|NCT00178503|Drug|Methylphenidate-extended release|Methylphenidate-extended release was taken in the morning of the MPH treatment trial. Each participant underwent 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 10 mg Ritalin LA to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took from 10 mg Ritalin LA to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 20 mg Ritalin LA to 40 mg.
12052546|NCT00178503|Drug|Methylphenidate-immediate release|Methylphenidate-immediate release was taken in the late afternoon. Each participant underwent 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 2.5 mg IR-MPH and 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took 2 weeks of 5 mg IR-MPH and 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 1 week of 5 mg IR-MPH and 2 weeks of 10 mg.
12052547|NCT00178503|Other|Placebo|Participants will take a placebo for 1 full week of the randomized drug trial. They will take one capsule in the morning and one capsule in the afternoon.
12052548|NCT00178490|Drug|High blood pressure treatment|Participants who are identified as having high blood pressure will be given by a pediatric nephrologist a 12-month treatment plan for their high blood pressure. The treatment plan will include a combination of diet, weight loss, increased exercise, and if needed, blood pressure medication. Participants receiving medication treatment will be treated with a calcium channel blocker and/or ACE inhibitor.
12052549|NCT00178477|Procedure|MRI with breath-holding|Breath holding for diminished tumor motion.
12052550|NCT00178464|Drug|aspirin|81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
12052551|NCT00178451|Drug|Abciximab|
12052552|NCT00178438|Device|Capsule Endoscopy|
12052553|NCT00178425|Procedure|Serial blood sampling as described in protocol|
12052554|NCT00178425|Procedure|Estimation of Creatinine Clearance at regular intervals|
12052555|NCT00178412|Behavioral|Care Project for Hospitalized Elders & Family Caregivers|"Phase 1 in-hospital contact: Family caregivers complete baseline data, listen to a tape about helping the elderly relative cope with hospitalization, and work on a mutual agreement/identification of goals for participation in family member's hospital care (i.e., selection of two complications to focus on based on patient's illness condition)
~Phase 2 pre-hospital discharge: Family caregivers listen to a second tape about coping with the hospital experience, participating in their family member's in-hospital care, and preparing for hospital discharge/transition to home"
12052556|NCT00178412|Behavioral|Comparison Group|"Phase 1 in-hospital contact: Family caregivers complete baseline data and listen to an informational tape about hospital policies.
~Phase 2 pre-hospital discharge: Family caregivers listen to a second informational tape about the hospital and medical center."
12052557|NCT00178399|Procedure|Stereotactic Body Radiation Therapy|
12052558|NCT00178373|Drug|Modafinil|
12052559|NCT00178373|Drug|sugar pill|
12052560|NCT00178360|Behavioral|Music Therapy|"During individual Music Therapy sessions, subjects will participate in a variety of active music-making opportunities, including: playing musical instruments, singing, improvising, learning relaxation techniques, song writing, and/or lyric analysis. The activities for each session will be determined by both subject and therapist, and will be selected based on preference, emotional state, and desired goals for the day.
~Group music therapy sessions will focus on improving socialization, depression, and group dynamics. In this setting, the Music Therapist will choose from the following interventions:
~Group singing
~Group drumming
~Music assisted relaxation
~Group song writing
~Lyric analysis
~Improvisation
~Music with art"
12052561|NCT00178347|Radiation|Exposure to irradiation|Treatment for Cancer using Radiation -dose will be the standard of Care for the type of Cancer being treated
12052562|NCT00178321|Device|earplugs|
12052563|NCT00178295|Radiation|Radiation Therapy|standard of care for the cancer being treated
12052564|NCT00178282|Procedure|Pelvic Floor Muscle exercises|
12052565|NCT00178269|Drug|docetaxel|
12052566|NCT00178269|Procedure|Radiation Therapy|
12052567|NCT00178256|Drug|Paclitaxel|On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
12052568|NCT00178256|Procedure|Radiation Therapy|Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
12052569|NCT00178243|Procedure|3D Conformal Radiation Therapy and Radiosurgery|
12052570|NCT00178217|Behavioral|Music Therapy|The music therapy intervention will consist of approximately 30 minutes of active music making and/or improvisation. The session will begin at least 15 minutes prior to receiving the Botox injections, followed by the necessary time of the procedure and 10 minutes following. During this time the patient will be encouraged to actively engage in a musical activity of his/her choice. After the last injection has been administered, the monitoring and music therapy will continue for up to 10 minutes, and focus on soothing and relaxation rather than on distraction.
12052571|NCT00178191|Other|Bladder diary|3-day bladder diary
12052572|NCT00178191|Other|Questionnaires|Incontinence Quality of Life questionnaires
12052573|NCT00178191|Procedure|Urodynamics|Urodynamics
12052574|NCT00178191|Other|Pad weight|Pad weight
12052575|NCT00178178|Device|Breg Pain Care 3000 Catheter|Device: Breg Pain Care 3000 Catheter
12052576|NCT00178178|Drug|Bupivicaine 0.5%|Drug: Bupivicaine 0.5 %
12052577|NCT00178178|Drug|Placebo|Drug: Placebo
12052578|NCT00178165|Procedure|Skill Training Condition - problem solving training|
12052579|NCT00178165|Procedure|REACH for TLC (Telephone Linked Computer) system|
12052580|NCT00178139|Behavioral|Music Therapy|Music Therapy
12052581|NCT00178126|Device|Skin Protection Wheelchair Seat Cushion|Cushion receiving CMS code for Skin Protection Wheelchair Cushion
12052582|NCT00178126|Device|Segmented Foam Wheelchair Seat Cushion|General use class wheelchair seat cushion
12052583|NCT00178113|Drug|- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)|
12052584|NCT00178113|Drug|- Certagen (multivitamins with minerals)|
12052585|NCT00178100|Behavioral|Interpersonal Psychotherapy|
12052586|NCT00178100|Drug|paroxetine|
12052587|NCT00178074|Behavioral|total sleep deprivation|
12052588|NCT00178074|Procedure|PET imaging|
12052589|NCT00178061|Behavioral|Interpersonal Social Rhythm Therapy (IPSRT)|
12052590|NCT00178048|Drug|paroxetine|
12052591|NCT00178035|Drug|paroxetine|
12052592|NCT00178035|Behavioral|One night of Total Sleep Deprivation|
12052593|NCT00178022|Behavioral|Case management and problem solving therapy|
12052594|NCT00178009|Behavioral|self-paced instruction|Patients and caregivers review a DVD as often as they wish on how to care for routine and emergency procedures associated with their artificial heart
12052595|NCT00177996|Drug|sertraline hydrochloride|The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines.
12052596|NCT00177983|Behavioral|(relapse rate)|
12052597|NCT00177970|Drug|intravenous immunoglobulin G (IVIG)|IVIG to be given IV to patients with C-Diff .
12052598|NCT00177970|Drug|Placebo|Placebo to be given IV to patients with C-Diff
12052599|NCT00177892|Procedure|sleep disruption|experimentally-induced Sleep Fragmentation
12052600|NCT00177892|Procedure|sleep with and without positive pressure|OSAH patients with and without chronic positive airway pressure therapy
12052601|NCT00177879|Behavioral|website comparison|
12052602|NCT00177866|Drug|Celebrex|"Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
12052603|NCT00177866|Drug|placebo|placebo PO BID for either the first eight weeks or the last eight weeks of the study.
12052604|NCT00177853|Drug|celecoxib|Patients will start celecoxib (200mg PO BID) beginning 3-5 days prior to chemoradiation at home and receive the drug until 30 days following the completion of chemoradiation.
12052605|NCT00177853|Drug|irinotecan|Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
12052606|NCT00177853|Procedure|concurrent radiotherapy|50.4 cGy of standard external beam radiation. The radiation will be given in 28 treatments of 1.8 cGy per treatment over 5.5 weeks. This will be given in an outpatient setting.
12052607|NCT00177840|Procedure|acupuncture|
12052608|NCT00177775|Drug|MucoMilk product|
12052609|NCT00177762|Behavioral|behavior weight loss|
12052610|NCT00177749|Drug|Posaconazole|
12052611|NCT00177710|Drug|Amphotericin B|
12052612|NCT00177697|Behavioral|behavioral weight loss program|
12052613|NCT00177684|Drug|Amphotericin B|
12052614|NCT00177671|Drug|Escitalopram|Escitalopram, 10mg to 20mg daily.
12052615|NCT00177671|Drug|Donepezil|Donepezil, 5mg to 10mg daily.
12052616|NCT00177671|Drug|Venlafaxine|Venlafaxine, 150mg to 300mg daily.
12052617|NCT00177671|Drug|Placebo|
12052618|NCT00177671|Drug|Duloxetine|
12052619|NCT00177645|Procedure|sodium bicarbonate|inhalation of sodium bicarbonate or sodium chloride
12052620|NCT00177632|Behavioral|behavioral weight loss|
12052621|NCT00177619|Drug|Alendronate|
12052622|NCT00177606|Behavioral|withdrawal of life sustaining treatments|
12052623|NCT00177593|Behavioral|behavioral weight loss|
12052624|NCT00177580|Drug|Pravastatin|
12052625|NCT00177567|Drug|lithium carbonate|
12052626|NCT00177567|Drug|Depakote-ER|
12052627|NCT00177567|Drug|risperidone|
12052628|NCT00177567|Drug|olanzapine|
12052629|NCT00177567|Drug|paroxetine|
12052630|NCT00177567|Drug|bupropion|
12052631|NCT00177567|Drug|lamotrigine|
12052632|NCT00177567|Drug|venlafaxine|
12052633|NCT00177567|Drug|tranylcypromine|
12052634|NCT00177567|Drug|mirtazapine|
12052635|NCT00177554|Drug|Chemotherapy and Radioimmunotherapy|CHOP-R x 3 cycles followed by zevalin and extended rituximab
12052636|NCT00177541|Behavioral|Biofeedback, pelvic floor muscle training, fMRI|Biofeedback, pelvic floor muscle training, fMRI
12052637|NCT00177528|Drug|venlafaxine-XR|
12052638|NCT00177515|Behavioral|"video doctor, computer module"|computerized counseling about emergency contraception and peri-conception folate
12052639|NCT00177502|Behavioral|behavioral exercise intervention|
12052640|NCT00177489|Behavioral|multicomponent psychosocial intervention|The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
12052641|NCT00177489|Other|Control arm|"Caregivers in the control group received 2 brief check-in telephone calls during the 6-month intervention."
12052642|NCT00177476|Behavioral|behavioral weight loss|
12052643|NCT00177463|Drug|L-carnosine|an antioxidant and AGE inhibitor, 500 mg/day, increasing each week in titration reaching 2000 mg/day in 4 weeks and maintained for rest of trial
12052644|NCT00177437|Behavioral|home testing kit|
12052645|NCT00177424|Drug|sertraline|Subjects will initially be started on either sertraline 12.5mg/d or placebo and will receive this dose for 3 days. Subjects will then be increased to 25mg/d for 4 days, then 50mg/d for 7 days, then increased to 75mg/d. Seventy-five mg per day is the target dose for the remainder of the subject's participation in the study. The study medication will not be titrated past 75mg/d.
12052646|NCT00177424|Drug|Placebo|matching placebo tablets
12052647|NCT00177411|Drug|Parathyroid Hormone-related Protein|Parathyroid Hormone-related Protein in doses started at a 4 microgram single bolus intravenous dose. Dose will be increase to a maximum of 400 micrograms or until a dose limiting toxicity occurs at a lower dose.
12052648|NCT00177398|Drug|Glargine insulin vs regular insulin|
12052649|NCT00177385|Behavioral|Modest sleep deprivation with sleep hygiene education|
12052650|NCT00177372|Drug|mifepristone/misoprostol|mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
12052651|NCT00177359|Behavioral|gait intervention|
12052652|NCT00177346|Device|CAS with cerebral protection|
12052653|NCT00177346|Device|CAS without cerebral protection|
12052654|NCT00177333|Drug|Doxycycline|
12052655|NCT00177307|Drug|Bevacizumab|Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
12052656|NCT00177307|Drug|Capecitabine|Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
12052657|NCT00177307|Drug|Oxaliplatin|Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
12052658|NCT00177294|Drug|Escitalopram|Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
12052659|NCT00177294|Behavioral|Interpersonal Psychotherapy|16 sessions of interpersonal psychotherapy (IPT)
12052660|NCT00177294|Behavioral|Clinical Monitoring|16 weeks of depression care management(DCM). No psychotherapy will be provided.
12052661|NCT00177281|Drug|S CKD602|
12052662|NCT00177268|Other|Blood draw, skin biopsy or urine collection|Up to 9 blood draws/year of 60 ml of whole blood. One 6 mm punch biopsy may be obtained up to 4 times per year.
12052663|NCT00177255|Drug|Docetaxel|"Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
~Cycle 2 will begin on day 22."
12052664|NCT00177255|Drug|Capecitabine|"Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
~Each cycle will consist of 21 days.
~Cycle 2 will begin on day 22."
12052665|NCT00177242|Drug|Gefitinib|
12052666|NCT00177229|Behavioral|Family-based treatment|20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months. Medical monitoring throughout study period.
12052667|NCT00177216|Drug|Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
12052668|NCT00177216|Drug|Escitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
12052669|NCT00177216|Drug|Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
12052670|NCT00177203|Behavioral|Brief Behavioral Treatment of Insomnia or Information|"The behavioral treatment involves education about sleep and its disorders; habits that help and hurt sleep; and recommendations about sleep hours and time in bed. It involves two meetings with a nurse who is part of the research team.
~In the information condition, participants are given similar information in printed brochures that are published by the American Academy of Sleep Medicine. They are instructed to read the information."
12052671|NCT00177177|Drug|L-carnosine (dietary supplement)|an antioxidant and AGE inhibitor, 500 mg/day, titration each week to reach 2000 mg/day in 4 weeks L-Carnosine is a dietary supplement
12052672|NCT00177164|Drug|Injectable Risperidone (Consta) or oral antipsychotic|"Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks
~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
12052673|NCT00177138|Drug|Tacrolimus|Starting POD #1 0.06 mg/kg/day in 2 divided doses;
12052674|NCT00177138|Drug|Alemtuzumab|30 mg IV intra-op and POD #12; then 30 mg IV >monthly for 1 year (only if ALC>200 mm, up to a total of 10 doses in year)
12052675|NCT00177125|Device|ErectAid|
12052676|NCT00177112|Procedure|clean patient preparation for cystoscopy|
12052677|NCT00177112|Procedure|sterile patient preparation for cystoscopy|
12052678|NCT00177099|Drug|FK506, GP11046, GP11511|
12052679|NCT00177086|Other|Alfuzosin Hydrochloride|One tablet every day for 4 weeks
12052680|NCT00177060|Drug|hydromorphone|
12052681|NCT00177047|Procedure|Stem Cell Transplant|As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
12052682|NCT00177047|Drug|Cyclophosphamide + Mesna|Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
12052683|NCT00177047|Drug|Melphalan|Administered intravenously 200 mg/m^2
12052684|NCT00177047|Biological|Granulocyte-colony stimulating factor|Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
12052685|NCT00177034|Drug|Narrow Band UVB Treatment|
12052686|NCT00177021|Drug|Aldara Cream 5%|
12052687|NCT00177008|Drug|Aripiprazole|
12052688|NCT00176995|Drug|15% Eflornithine Hdyrochloride|
12052689|NCT00176982|Drug|Hydroxychloroquine|
12052690|NCT00176969|Drug|Capsaicin|
12052691|NCT00176956|Procedure|Skin Biopsy|Skin biopsy.
12052692|NCT00176943|Drug|Aldara Cream 5%|
12052693|NCT00176930|Procedure|Stem Cell Transplant|Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
12052694|NCT00176930|Drug|Cyclophosphamide|60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
12052695|NCT00176930|Radiation|Total Body Irradiation|On Day -4, -3, -2, -1 total body irradiation is given twice daily.
12052696|NCT00176930|Drug|Busulfan|When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
12052697|NCT00176917|Procedure|Stem Cell Transplant|The purpose of hematopoietic cell transplantation is to introduce hematopoietic cells from a normal donor that contains the enzyme able to get rid of the substances that have accumulated in the body of patients with storage diseases. Hematopoietic cells can come from bone marrow, peripheral blood (i.e., the blood circulating in our body's blood vessels) or umbilical cord blood (i.e. blood taken from the umbilical cord after a baby is born and umbilical cord is cut).
12052698|NCT00176917|Drug|Busulfan, Cyclophosphamide, ATG|"Prior to transplantation, subjects will receive BUSULFAN intravenously (IV) via the Hickman line twice daily for 4 days, CYCLOPHOSPHAMIDE intravenously via the Hickman line once a day for 4 days, and ANTI-THYMOCYTE GLOBULIN IV via the Hickman line twice daily for three days before the transplant. These three drugs are being given to help the new marrow take and grow. METHYLPREDNISOLONE will be given as a pre-medication for the ATG."
12052699|NCT00176904|Procedure|Stem Cell Transplant|The purpose of hematopoietic cell transplantation is to introduce hematopoietic cells from a normal donor that contains an enzyme able to get rid of the substances that have accumulated in the body of patients with storage diseases. Hematopoietic cells can come from bone marrow, peripheral blood (i.e., the blood circulating in our body's blood vessels) or umbilical cord blood (i.e., blood taken from the umbilical cord after a baby is born and umbilical cord is cut).
12052700|NCT00176904|Drug|Busulfan, Cyclophosphamide, Antithymocyte Globulin|"Subjects will receive BUSULFAN intravenously (IV)- patients < or= 12 kg 1.1 mg/kd/dose IV every 6 hours for 16 doses; patients > 12kg 0.8 mg/kg/dose IV every 6 hours for 16 doses - via the Hickman line four times daily for 4 days, CYCLOPHOSPHAMIDE intravenously (50 mg/kg/day IV over 2 hours) via the Hickman line once a day for 4 days, and ANTI-THYMOCYTE GLOBULIN IV (15 mg/kg/day over 2 hours) via the Hickman line twice daily for three days before the transplant. These three drugs are being given to help the new marrow take and grow. METHYLPREDNISOLONE will be given as a pre-medication for the ATG."
12052701|NCT00176891|Procedure|Stem Cell Transplant|enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following
12052702|NCT00176891|Drug|Laronidase ERT|Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following.
12052703|NCT00176878|Procedure|Stem cell transplant|Stem cell transplant on Day 0 - healthy marrow from an unrelated individual. A minimum of 1.0 x 10^9/kg nucleated cells/kg ideal body weight will be collected with a goal of 2.0 x 10^9/kg.
12052704|NCT00176878|Drug|Fludarabine monophosphate|fludarabine 175 mg/m^2 (total) on Days -6 through -3.
12052705|NCT00176878|Procedure|Total lymphoid irradiation|Dose 500 cGy radiation therapy to specific areas of the body
12052706|NCT00176878|Drug|Busulfan|Busulfan 8 mg/kg (total) on Days - 8 and -7 (orally or through the catheter),
12052707|NCT00176878|Biological|anti-thymocyte globulin|anti-thymocyte globulin (ATG) 15 mg/kg on days -2 and -1 via catheter
12052708|NCT00176865|Procedure|Stem Cell Transplant|IV on Day 0
12052709|NCT00176865|Drug|Fludarabine|30mg/m^2 IV Day -7 through Day -3
12052710|NCT00176865|Drug|Melphalan|140 mg/m^2 IV Day -1
12052711|NCT00176865|Drug|Anti-thymocyte globulin (ATG)|30 mg/kg IV Day -5 through Day -1
12052712|NCT00176865|Drug|Campath 1H|0.2 mg/kg IV X 5 days (used as an alternative to Anti-thymocyte globulin (ATG) if unable to tolerate ATG) Day -10 through Day -6
12052713|NCT00176865|Drug|Cyclosporin A|2.5 mg/kg IV every 12 hours (adults) or every 8 hours (children <40 kg) maintaining a level of >200mg/L Day -3 until Day +180 when, if no GVHD, the dose will be tapered 10% per week beginning on day 181
12052714|NCT00176865|Drug|Mycophenolate mofetil|15 mg/kg IV or orally bid and discontinued on Day +45 unless GVHD is present
12052715|NCT00176865|Drug|Intravenous immunoglobulin (IVIG)|500 mg/kg IV weekly beginning on Day +7 until Day +100
12052716|NCT00176852|Drug|Busulfan, Fludarabine, ATG, TLI|Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy
12052717|NCT00176852|Drug|Busulfan, Cyclophosphamide, ATG, GCSF|Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
12052718|NCT00176852|Drug|Campath, Fludarabine, Cyclophosphamide|Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
12052719|NCT00176852|Radiation|Total Body Irradiation|300 cGY Day -1
12052720|NCT00176852|Procedure|Stem cell infusion|Given Day 0
12052721|NCT00176839|Procedure|Stem Cell Transplant|Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
12052722|NCT00176839|Drug|Busulfan|Prior to transplantation, subjects will receive BUSULFAN via the central venous line, four times a day for four days (days -7 through -4).
12052723|NCT00176839|Drug|Cyclophosphamide|Prior to stem cell transplantation, subjects will receive CYCLOPHOSPHAMIDE via the central venous line once a day for two days on days -3 and -2.
12052724|NCT00176839|Drug|Melphalan|MELPHALAN will be given via the central venous line for one day, on day -1, prior to stem cell transplantation.
12052725|NCT00176839|Drug|G-CSF|G-CSF is to be given daily IV beginning on day +1 until ANC 2.5 x 109/L.
12052726|NCT00176839|Drug|ATG|ATG will be administered to umbilical cord blood recipients.
12052727|NCT00176826|Procedure|Stem Cell Transplant|Infusion of hematopoietic stem cells (bone marrow, cord blood, peripheral blood stem cells) following myeloablative conditioning regimen.
12052728|NCT00176826|Drug|Myeloablative conditioning regimen|Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
12052729|NCT00176813|Drug|Gemcitabine|
12052730|NCT00176813|Drug|Cisplatin|
12052731|NCT00176813|Drug|Celecoxib|
12052732|NCT00176800|Drug|Tetrathiomolybdate (TM)|Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
12052733|NCT00176800|Procedure|Radiation|Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
12052734|NCT00176800|Procedure|Surgery|The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
12052735|NCT00176787|Drug|Capecitabine|
12052736|NCT00176787|Procedure|Radiation|
12052737|NCT00176787|Procedure|Surgery|
12052738|NCT00176774|Drug|Irinotecan|Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
12052739|NCT00176774|Drug|5-Fluorouracil|Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
12052740|NCT00176774|Drug|Leucovorin|Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
12052741|NCT00176774|Drug|Tetrathiomolybdate|one 40 mg oral (by mouth) dose of TM three times a day with meals and one 60 mg oral dose (without food) at bedtime beginning at bedtime on day 1 of your first 6-week cycle of treatment. The between meal dose must be taken at least one hour before or one hour after a meal.
12052742|NCT00176761|Drug|Interleukin-2 (IL-2)|
12052743|NCT00176748|Drug|AG 6013736|5 mg po bid
12052744|NCT00176735|Drug|Capecitabine|
12052745|NCT00176722|Other|table tilt|One group randomized to table tilt. One group will be flat.
12052746|NCT00176696|Device|Use of FACE monitor and BIS monitor|Face monitor records facial muscle activity
12052747|NCT00176683|Procedure|Capnography|device which measures carbon dioxide at intubation
12052748|NCT00176670|Drug|midazolam or GameBoy or parental presence|
12052749|NCT00176657|Drug|HEMOBAG Assessment|
12052750|NCT00176644|Drug|Transdermal Estradiol|"application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
12052751|NCT00176631|Dietary Supplement|licorice root extract|Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
12052795|NCT00176384|Behavioral|Aerobic endurance exercise training (ergometer)|
12052752|NCT00176631|Drug|docetaxel|All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.
12052753|NCT00176618|Drug|sulindac|Sulindac 150 mg po BID
12052754|NCT00176618|Drug|curcumin|Curcumin 250 mg po BID
12052755|NCT00176605|Drug|Etoposide|50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide.
12052756|NCT00176605|Drug|Cyclophosphamide|50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration of cyclophosphamide at this dose has been well tolerated
12052757|NCT00176592|Drug|Betaseron|Betaseron 250 micrograms injected SQ every other day
12052758|NCT00176592|Drug|Copaxone|Copaxone 20 mg injected SQ every day (glatiramer acetate)
12052759|NCT00176579|Procedure|dual x-ray absorptiometry|Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
12052760|NCT00176566|Drug|Lozenge Intake|of green tea lozenges weighing 6 grams each, containing 0.45 grams of green tea solids eight (8) times daily for 12 weeks to patients with oral leukoplakia compared to the administration of a lozenge that does not contain green tea (i.e. a placebo lozenge).
12052761|NCT00176553|Drug|Dextromethorphan|Patients will receive an inert carrier with or without dextromethorphan. The study drug will be administered at 1.5 mg/kg/dose on a BID schedule. The first dose to be given prior to each scheduled intravenous and/or intrathecal administration of methotrexate and continued for a total of seven days.
12052762|NCT00176540|Drug|dextromethorphan hydrobromide|
12052763|NCT00176527|Biological|recombinant interferon alfa-2b|
12052764|NCT00176527|Drug|docetaxel|
12052765|NCT00176527|Drug|estramustine phosphate sodium|
12052766|NCT00176527|Drug|isotretinoin|
12052767|NCT00176527|Genetic|polyacrylamide gel electrophoresis|
12052768|NCT00176527|Genetic|protein expression analysis|
12052769|NCT00176527|Other|immunohistochemistry staining method|
12052770|NCT00176514|Drug|Administration of the antineoplastic|
12052771|NCT00176501|Biological|therapeutic allogeneic lymphocytes|If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
12052772|NCT00176488|Drug|epirubicin|Epirubicin (100 mg/m2) will be given on Day 1
12052773|NCT00176488|Drug|vinorelbine|Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
12052774|NCT00176475|Biological|rituximab|Patients will receive a single day infusion of standard dose rituximab (375 mg/m2) on days -1, 6, 13, 20 approximately every 4 months (in conjunction with alternating doses of the lymphocyte infusion).
12052775|NCT00176475|Biological|therapeutic allogeneic lymphocytes|The product will then be assigned to the specific patient and the released product will be transported to and administered to the patient at CINJ, after premedication of the patient with acetaminophen 650 mg PO and diphenhydramine- HCl 25 mg PO. Blood product administration will be every 8 weeks and undertaken according to CINJ standard procedures
12052776|NCT00176462|Drug|aminopterin|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052777|NCT00176462|Drug|L-asparaginase|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052778|NCT00176462|Drug|cyclophosphamide|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052779|NCT00176462|Drug|cytarabine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052780|NCT00176462|Drug|daunomycin|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052781|NCT00176462|Drug|dexamethasone|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052782|NCT00176462|Drug|6-mercaptopurine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052783|NCT00176462|Drug|methotrexate|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052784|NCT00176462|Drug|6-thioguanine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052785|NCT00176462|Drug|vincristine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
12052786|NCT00176462|Drug|Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)|
12052787|NCT00176462|Drug|Leucovorin|
12052788|NCT00176449|Drug|Bupropion SR|150mg twice a day (starting with 150mg once a day for three days)
12052789|NCT00176449|Drug|Placebo Oral Tablet|Comparable placebo
12052790|NCT00176436|Behavioral|Diet support group|Diet support group weekly and exercise sessions 3 times/week, placebo medication
12052791|NCT00176436|Behavioral|Group counseling and exercise|Support group weekly and exercise sessions 3 times/week for 24 weeks
12052792|NCT00176423|Drug|galantamine|see arm/group description
12052793|NCT00176410|Drug|fluvastatin|40mg fluvastatin daily
12052794|NCT00176397|Procedure|Percutaneous coronary intervention (left main)|
12052796|NCT00176371|Behavioral|physical exercise|
12052797|NCT00176358|Device|PTCA and Stent Implantation|
12052798|NCT00176358|Behavioral|Exercise Training|
12052799|NCT00176345|Behavioral|Exercise Training|
12052800|NCT00176332|Drug|rosuvastatin|
12052801|NCT00176319|Behavioral|Aerobic endurance exercise training (ergometer)|
12052802|NCT00176306|Drug|Levofloxacin 750 mg IV|PK in obesity
12052803|NCT00176293|Drug|dexamethasone|oral dexamethasone, 12mg BID on days 1, 2, 3, 4, & 5 of each 28-day cycle
12052804|NCT00176293|Drug|doxorubicin|Doxorubicin 50mg/m^2 I.V. on day 5
12052805|NCT00176280|Drug|Leukine|
12052806|NCT00176280|Drug|Dexamethasone|
12052807|NCT00176267|Radiation|Radiotherapy|50 cGy on days 1, 2, 8, 15, 22, 23, 29 & 36 of chemotherapy
12052808|NCT00176267|Drug|Paclitaxel|75 mg/m2 intravenously over one hour on Days 1, 8, 15, 22, 29 and 36
12052809|NCT00176267|Drug|Carboplatin|AUC of 6 on Days 1 & 22
12052810|NCT00176254|Radiation|Radiotherapy|80 centigray (cGy) on Day 1 & 2 and 22 & 23 of chemotherapy
12052811|NCT00176254|Drug|Paclitaxel|225 mg/m2 intravenously over three hours on Days 1 and 22
12052812|NCT00176254|Drug|Carboplatin|Area under the curve (AUC) of 6 will be given intravenously over 30 minutes on days 1 and 22
12052813|NCT00176241|Drug|gemcitabine|2000-3000mg/m2 IV on days 1 & 15
12052814|NCT00176241|Drug|paclitaxel|150 mg/m2 IV on days 1 & 15
12052815|NCT00176241|Radiation|radiation|50-80 cGy on days 1,2,15,16
12052816|NCT00176228|Drug|Lamotrigine|"It is a mood stabilizer that is clinically the first choice if patients present with depression and is effective in adults for mania in maintenance phase. So it is administered to see how effective it is in children and adolescents.
~The dose of lamotrigine will be 12.5 mg per day beginning the first day. It is increased in 12.5 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg."
12052817|NCT00176215|Procedure|survival failure of more than 20 %|
12052818|NCT00176202|Drug|Divalproex Sodium|Divalproex sodium is a mood stabilizer
12052819|NCT00176202|Drug|risperidone|Risperidone is a second generation antipsychotic and antimanic drug
12052820|NCT00176189|Device|All ceramic FPDs|
12052821|NCT00176176|Device|EEG|
12052822|NCT00176163|Behavioral|Operant behavioral treatment; Drug: THC|
12052823|NCT00176137|Procedure|preoperative radiochemotherapy|
12052824|NCT00176124|Procedure|leukocyte depletion of whole blood|
12052825|NCT00176124|Other|Leukocyte filtration/Depletion|leukocyte depletion filters as used routinely: filters (prestorage) inherent to the blood bag sets by gravity force following storage on cold plate for 2 hours
12052826|NCT00176111|Procedure|peripheral nerve stimulation (procedure)|
12052827|NCT00176098|Procedure|Hypnoanalgesia; Hypnotic shielding|
12052828|NCT00176059|Drug|intravenous immunoglobulins (IVIG)|
12052829|NCT00176059|Procedure|kidney transplantation|
12052830|NCT00176046|Drug|viscum album pini|s.c. injection of 0,001-20 mg 3 times per week
12052831|NCT00176046|Drug|viscum album pini|s.c. injection 0,001-20 mg 3 times per week
12052832|NCT00176020|Drug|nicotinic acid|
12052833|NCT00176007|Procedure|Hypoxia|
12052834|NCT00175981|Drug|sildenafil, fluvoxamine|
12052835|NCT00175968|Procedure|bed rest, hypocaloric nutrition|
12052836|NCT00175955|Drug|Levetiracetam|
12052837|NCT00175929|Other|Placebo|Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
12052838|NCT00175929|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
12052839|NCT00175929|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
12052840|NCT00175916|Drug|Brivaracetam (ucb 34714)|10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.
12052841|NCT00175903|Drug|Levetiracetam|Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
12052842|NCT00175903|Drug|Carbamazepine Controlled Release (CBZ-CR)|Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
12052843|NCT00175903|Drug|Valproate Extended Release|Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
12052844|NCT00175890|Drug|Levetiracetam|Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
12052845|NCT00175890|Other|Placebo|Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
12052846|NCT00175877|Biological|Certolizumab Pegol|"Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
~Duration: Until end of study."
12052847|NCT00175864|Drug|Seletracetam (ucb 44212)|
12052848|NCT00175851|Drug|Seletracetam (ucb 44212)|
12052849|NCT00175838|Drug|Hydroxyurea|Hydroxyurea (or hydroxycarbamide) is an antineoplastic drug commonly used to treat haematological malignancies.
12052850|NCT00175838|Drug|Aspirin|Aspirin is an anti-aggregating agent, and has been shown to reduce/alleviate minor ischaemic symptoms.
12052851|NCT00175825|Other|Placebo|Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
12052852|NCT00175825|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
12052853|NCT00175812|Drug|all-trans retinoic acid (ATRA)|All-trans retinoic acid 22.5 mg/square meter twice daily days 1-14
12052854|NCT00175812|Drug|Valproic acid|Valproic acid, highest dose without side effects from day 3 until progression
12052855|NCT00175812|Drug|Theophyllin|Theophyllin, targetted serum level 50-100 from day 3 until progression
12052856|NCT00175760|Procedure|Diagnosis of Celiac Disease|During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.
12052857|NCT00175747|Drug|Inhaled Budesonide 800 µg twice daily|
12052858|NCT00175734|Procedure|High Hemoglobin Concentration|The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
12052859|NCT00175734|Procedure|Low Hemoglobin Concentration|The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
12052860|NCT00175721|Procedure|The Combined Cardiac Kidney Diabetes Care Clinic|See Detailed Description.
12052861|NCT00175695|Drug|Recombinant human activated protein C or drotrecogin alpha|We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that has the potential to modify disease activity in pre-eclampsia by reducing coagulation and inflammation disorders.
12052862|NCT00175682|Drug|Prazosin HCL|See Detailed Description
12052863|NCT00175669|Drug|Botox injections|Data not known.
12052864|NCT00175656|Procedure|Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ|See Detailed Description.
12052865|NCT00175643|Drug|imiquimod|
12052866|NCT00175630|Procedure|Administration of a femoral nerve block (bupivacaine HCL)|See Detailed Description
12052867|NCT00175617|Drug|Spironolactone|This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
12052868|NCT00175617|Drug|Minoxidil|This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
12052869|NCT00175604|Drug|Botox|The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox.
12052870|NCT00175591|Procedure|Administration of a femoral nerve block (bupivacaine HCL)|No details specified
12052871|NCT00175565|Drug|inhaled fluticasone 500 mcg b.i.d.|
12052872|NCT00175552|Behavioral|Psychotherapy Training|
12052873|NCT00175539|Behavioral|psychoeducational intervention|three 1.5 hour long group psychoeducational sessions
12052874|NCT00175526|Behavioral|preeclampsia|This research project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is specific to the condition. To develop and validate the tool w
12052875|NCT00175513|Drug|Valacyclovir (Valtrex)|
12052876|NCT00175500|Device|Large Diameter Femoral Head|
12052877|NCT00175487|Procedure|Hip replacement|This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
12052878|NCT00175474|Procedure|knee surgery|
12052879|NCT00175461|Procedure|hip surgery|Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty
12052880|NCT00175448|Procedure|physiotherapy|See Detailed Description.
12052881|NCT00175435|Biological|Resiquimod gel|3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
12052882|NCT00175435|Biological|Resiquimod gel|3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
12052883|NCT00175435|Biological|Resiquimod gel|3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
12052884|NCT00175422|Behavioral|The Period of PURPLE Crying Program|There are two treatment arms in the study. The first half of all subjects (n=500) will receive the PURPLE intervention materials (a video and a pamphlet) about infant crying. The second arm will receive comparable materials on infant safety and SIDS.
12052885|NCT00175409|Procedure|Blood collection|For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection.
12052886|NCT00175409|Procedure|Blood collection|For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
12052887|NCT00175396|Procedure|Androgen suppression, radiotherapy|Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by an external beam radiation boost lasting 3.2-4 weeks (32 Gy in 16 equal fractions).
12052888|NCT00175396|Procedure|Androgen suppression, radiotherapy, iodine 125 brachytherapy|Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by iodine 125 brachytherapy carried out 14-25 days after the last external beam treatment.
12052889|NCT00175383|Drug|luteinizing hormone-releasing hormone (LHRH) short acting or long acting|See Detailed Description.
12052890|NCT00175370|Drug|Vancomycin|Randomized double-blind equivalence trial to test the hypothesis that 2 days is equivalent to 7 days of vancomycin treatment for intravascular device associated bacteremia due to coagulase negative staphylococcus. The definitions for the surveillance of intravascular device associated bacteremia from the Laboratory Centre for Disease Control-Health Canada will be used. Surveillance blood cultures on days 4 and 9 following removal of intravascular device. Relatedness of strains will be determined by pulsed-field gel electrophoresis (PFGE).
12052891|NCT00175357|Drug|Methadone|The dose of the drug will be determined by a physician. The oral drug will be administered 1 dose per days, 7 days per week.
12052892|NCT00175357|Drug|Diamorphine hydrochloride|The dose of the drug will be determined by a physician. The injected drug will be administered up to 3 doses per day, 7 days per week.
12052935|NCT00174967|Drug|Febuxostat|Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
12052936|NCT00174967|Drug|Febuxostat|Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
12052937|NCT00174954|Procedure|MRI|Subjects underwent MRI to evaluate tophi.
12052893|NCT00175344|Procedure|Scar massage.|To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars.
12052894|NCT00175318|Behavioral|Motivational Interviewing|Beginning at 12 months of age, regular application of fluoride varnish will be an option that a mother in the MI group may choose for her child. Control families will receive dental health information from a pamphlet, and will have access to fluoride varnish at local dental clinics.
12052895|NCT00175305|Drug|Sandostatin LAR|
12052896|NCT00175292|Drug|Probiotic - VSL#3|
12052897|NCT00175279|Behavioral|Opinion leader generated and endorsed evidence summaries|
12052898|NCT00175266|Drug|alemtuzumab|
12052899|NCT00175266|Procedure|islet transplant|
12052900|NCT00175266|Drug|infliximab|
12052901|NCT00175253|Drug|alemtuzumab|
12052902|NCT00175253|Procedure|islet transplant|
12052903|NCT00175240|Behavioral|Evidence summaries endorsed by local opinion leaders|
12052904|NCT00175227|Drug|intravenous saline hydration + mannitol + furosemide|500 mls half-normal saline + 25g mannitol + 100 mg furosemide
12052905|NCT00175227|Drug|intravenous saline hydration|500 mls half-normal saline
12052906|NCT00175214|Behavioral|Multifaceted intervention (patient education, physician guidelines, reminders)|
12052907|NCT00175201|Procedure|Proactive care and rehabilitation|
12052908|NCT00175188|Device|Avanta (PIP joint implant with a titanium porous coating)|Implant is inserted at the time of surgery, after written consent
12052909|NCT00175175|Behavioral|"Allied health professional-run osteoporosis service (case-management)"|
12052910|NCT00175162|Device|Osteopal G vs. Refobacin-Palacos R bone cement|Bone cement
12052911|NCT00175149|Drug|Alfacalcidiol|Alfacalcidiol are given to patientwith CKD 3-4 and secondary hyperparathyrodism. The PTH level is lowered to normal range. with increasing dose of alfacalcidiol and are followed for 6 month.
12052912|NCT00175136|Device|Maxim TKA|Operation with Total Knee Arthroplasty and either an I-beam stem or a wedge stem of the tibial component.
12052913|NCT00175123|Drug|Botulinum A toxin|Intravesical injection. 12 IE/kg b.w.
12052914|NCT00175110|Behavioral|herbal therapy/botanical therapy (Hibiscus sabdariffa)|
12052915|NCT00175097|Other|Diet: soybeans and products made thereof|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybeans and products made thereof.
12052916|NCT00175097|Other|Diet: soybean flour and products made thereof|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean flour and products made thereof.
12052917|NCT00175097|Other|Diet: soybean milk|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean milk.
12052918|NCT00175097|Other|Diet: Animal protein based diet|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate animal protein.
12052919|NCT00175084|Behavioral|Comparison of dietary protein amino acid profile|Healthy adults over 50 years of age (men and postmenopausal women) will be assigned to one of two diets differing in lysine to arginine ration (0.7 vs. 1.4) for a 5 week period and then switched to the alternate diet, with a 2 to 4-week washout period, in a randomized crossover design. Blood samples will be collected three times in the fasted state and once 4-hours after the evening meal during the last week of each dietary period of measurement of concentration of plasma lipids, lipoproteins, apolipoproteins, arginine, C-reactive protein, nitrites/nitrates, homocysteine, lecithin-cholesterol acetyltransferase (LCAT), cholesteryl ester transfer protein (CETP), and LDL-receptor messenger ribonucleic acid (mRNA) expression.A 24-hour urine sample will be collected at the end of each phase to measure F2-isoprostanes as an indicator of whole body oxidation.
12052920|NCT00175071|Behavioral|Comparison of cooking oils|30 subjects will consume each of the two diets in randomized order for 5 weeks each. Diets will be designed to maintain body weight; will have 30% of energy as fat which 2/3 or 20% of energy will be either the conventional or reformulated fat. Blood lipids and C reactive protein (CRP) as well as indicators of how lipids are processed in the blood will be measured at the end of each dietary phase.
12052921|NCT00175058|Device|AO Therapy (aqueous oxygen)|90-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting
12052922|NCT00175045|Drug|Lansoprazole|Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.
12052923|NCT00175045|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.
12052924|NCT00175032|Drug|Lansoprazole and naproxen and aspirin|Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
12052925|NCT00175032|Drug|Celecoxib and aspirin|Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
12052926|NCT00175019|Drug|Febuxostat|Febuxostat 80 mg, tablets, orally, once daily.
12052927|NCT00175019|Drug|Febuxostat|Febuxostat 120 mg, tablets, orally, once daily.
12052928|NCT00175019|Drug|Allopurinol|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
12052929|NCT00175006|Other|Measurement of Tophi to validate procedure|Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.
12052930|NCT00174993|Drug|Pioglitazone|Pioglitazone 15 mg to 45 mg, tablets, orally, once daily for up to 48 months.
12052931|NCT00174993|Drug|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 48 months
12052932|NCT00174980|Drug|perfluorocarbon emulsion (Oxycyte) infusion|one time dose of 3mL/kg over 15 minutes
12052933|NCT00174967|Drug|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
12052934|NCT00174967|Drug|Febuxostat|Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
12052938|NCT00174941|Drug|Febuxostat|Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
12052939|NCT00174941|Drug|Febuxostat|Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
12052940|NCT00174941|Drug|Febuxostat|Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
12052941|NCT00174928|Drug|Lansoprazole|Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.
12052942|NCT00174928|Drug|Lansoprazole|Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
12052943|NCT00174915|Drug|Febuxostat|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
12052944|NCT00174915|Drug|Febuxostat|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
12052945|NCT00174915|Drug|Febuxostat|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
12052946|NCT00174915|Drug|Allopurinol|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
12052947|NCT00174915|Drug|Placebo|Placebo, orally, once daily for up to 28 weeks.
12052948|NCT00174902|Drug|inderal (drug), acetylsalicylic acid (drug)|
12052949|NCT00174889|Drug|Pregnenolone|
12052950|NCT00174876|Drug|Drug Abilify|
12052951|NCT00174863|Drug|SR31747A|
12052952|NCT00174850|Drug|Gaitril|
12052953|NCT00174837|Drug|Tirapazamine|in combination with cisplatin and concomitant radiation
12052954|NCT00174837|Drug|Cisplatin|with concomitant radiation
12052955|NCT00174824|Drug|Insulin glargine|
12052956|NCT00174811|Drug|telithromycin (HMR3647)|
12052957|NCT00174798|Drug|SSR240600C|once daily
12052958|NCT00174798|Drug|Placebo|oral
12052959|NCT00174798|Drug|Tolterodine|once daily
12052960|NCT00174785|Drug|dronedarone (SR33589)|oral administration (tablets)
12052961|NCT00174785|Drug|placebo|oral administration (tablets)
12052962|NCT00174772|Drug|docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy|docetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy
12052963|NCT00174772|Drug|docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin|docetaxel (20mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
12052964|NCT00174759|Drug|Clopidogrel|
12052965|NCT00174746|Drug|AVE2635A|
12052966|NCT00174733|Drug|Ciclesonide (XRP1526)|
12052967|NCT00174720|Drug|Ciclesonide (XRP1526)|
12052968|NCT00174707|Drug|epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile|Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)
12052969|NCT00174707|Drug|epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile|Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
12052970|NCT00174707|Drug|epidoxorubicine, docetaxel, cyclophosphamide|Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
12052971|NCT00174694|Drug|Telithromycin|
12052972|NCT00174681|Drug|Insulin Glargine|
12052973|NCT00174668|Drug|Insulin Glulisine|insulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal
12052974|NCT00174668|Drug|Insulin Therapy|NPH (70%) plus regular insulin or insulin aspart (30%)
12052975|NCT00174668|Drug|Insulin Glargine|1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG
12052976|NCT00174655|Drug|Doxorubicine + docetaxel sequential|doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles
12052977|NCT00174655|Drug|doxorubicine + cyclophosphamide sequential|doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles
12052978|NCT00174655|Drug|doxorubicine + cyclophosphamide combined|doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
12052979|NCT00174655|Drug|doxorubicine + docetaxel combined|doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
12052980|NCT00174642|Drug|Insulin Glargine|One daily injection in the evening. 100 U/ml
12052981|NCT00174642|Drug|Insulin Glulisine|Given immediately before each of the three main meals. 100 U/ml
12052982|NCT00174642|Drug|Metformin|At same dosages as the previous treatment
12052983|NCT00174642|Drug|insulin secretagogue|sulfonylurea or glinide
12052984|NCT00174629|Drug|Docetaxel/DDP|
12052985|NCT00174629|Drug|docetaxel/gemcitabine|
12052986|NCT00174616|Drug|Oxaliplatin, capecitabine, radiotherapy|"Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses
~Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks
~Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks"
12052987|NCT00174603|Drug|quetiapine|
12052988|NCT00174590|Drug|risperidone|
12052989|NCT00174577|Drug|Risperidone|
12052990|NCT00174564|Drug|oxaliplatin|
12052991|NCT00174551|Drug|prazosin|
12052992|NCT00174538|Drug|Codeine (30 mg)|
12052993|NCT00174525|Drug|AAB-001|
12052994|NCT00174512|Drug|GTN|
12052995|NCT00174512|Drug|Moxifloxacin|
12052996|NCT00174499|Drug|2 mg nicotine gum|2 mg nicotine gum
12052997|NCT00174499|Drug|4 mg nicotine gum|4 mg nicotine gum
12052998|NCT00174486|Drug|UK0369,003|
12052999|NCT00174486|Drug|Cialis (Tadalafil)|
12053000|NCT00174473|Drug|Voriconazole|
12053067|NCT00172536|Other|Control|Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.
12053001|NCT00174460|Drug|Somatropin|Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.
12053002|NCT00174460|Other|Control Arm|Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.
12053003|NCT00174447|Drug|Ziprasidone|Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid
12053004|NCT00174434|Drug|SU011248|SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.
12053005|NCT00174434|Drug|Paclitaxel|Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.
12053006|NCT00174421|Drug|Treatment with Genotropin in different dosages|
12053007|NCT00174408|Drug|Genotropin|
12053008|NCT00174395|Drug|eletriptan|
12053009|NCT00174382|Drug|Donepezil|donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
12053010|NCT00174369|Drug|PD-0325901|15 mg BID
12053011|NCT00174356|Drug|CI 1033|
12053012|NCT00174356|Drug|PACLITAXEL|
12053013|NCT00174356|Drug|CARBOPLATIN|
12053014|NCT00174343|Drug|exemestane (Aromasin®)|
12053015|NCT00174330|Drug|atorvastatin|
12053016|NCT00174330|Drug|amlodipine|
12053017|NCT00174317|Drug|Celecoxib|
12053018|NCT00174317|Drug|Diclofenac|
12053019|NCT00174304|Drug|Amlodipine/atorvastatin single pill|
12053020|NCT00174291|Drug|Somatropin|Liquid, daily to final height Maximum Dosage: 50 µg/kg/day
12053021|NCT00174278|Drug|Somatropin|
12053022|NCT00174265|Drug|asenapine|5-10 mg sublingually twice daily for 26 weeks
12053023|NCT00174265|Drug|olanzapine|5-20 mg by mouth once daily for 26 weeks
12053024|NCT00174252|Drug|Genotonorm (Somatropin)|0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years
12053025|NCT00174239|Drug|cabergoline|
12053026|NCT00174239|Drug|controlled-release levodopa / carbidopa|
12053027|NCT00174226|Drug|Atomoxetine|
12053028|NCT00174226|Drug|Buspirone|
12053029|NCT00174200|Drug|Risperidone 2 mg|
12053030|NCT00174187|Drug|Somatropin|liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day
12053031|NCT00174174|Drug|Modafinil|
12053032|NCT00174161|Behavioral|self-care, health behavior|
12053033|NCT00173992|Behavioral|Balance and Exercise|
12053034|NCT00173953|Procedure|immune response|
12053035|NCT00173901|Drug|ceftazidime|
12053036|NCT00173888|Drug|Docetaxel, Cisplatin|docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15
12053037|NCT00173888|Drug|Gemcitabine, Cisplatin|gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15
12053038|NCT00173875|Drug|Iressa|
12053039|NCT00173862|Drug|Gemcitabine, Ifosfamide|
12053040|NCT00173758|Procedure|co-culture of embryos and endometrial cells|
12053041|NCT00173745|Drug|botulinum toxin A injection|
12053042|NCT00173719|Device|Standard cane|
12053043|NCT00173706|Drug|L-Carnitine Injection|
12053044|NCT00173693|Behavioral|exercise for strength, balance, health education|
12053045|NCT00173667|Drug|Nifedipine 30 mg GITS|
12053046|NCT00173654|Procedure|blood drawing|
12053047|NCT00173641|Procedure|blood drawing|
12053048|NCT00173628|Procedure|blood drawing|
12053049|NCT00173615|Procedure|Extracorporeal membrane oxygenation|
12053050|NCT00173550|Procedure|Hysterectomy and Bilateral salpingo-oophorectomy|
12053051|NCT00173537|Procedure|for BMPR II study|
12053052|NCT00173537|Genetic|BMPRII|
12053053|NCT00173524|Behavioral|PharmacoEconomic Assessment|Collecting PE data.
12053054|NCT00173511|Device|24 hr Holter monitor|
12053055|NCT00173472|Drug|Chemotherapy|
12053056|NCT00173407|Procedure|immunohistochemical, methylation, gene transfection|
12053057|NCT00173251|Procedure|obtain surgical specimen for analysis|
12053058|NCT00173108|Behavioral|clinic-based intervention program and home-based intervention program|The intervention includes education of child development skills, health and feeding consultation, intervention of mother-infant interaction, and parent support. Clinic-based intervention program is delivered in clinic while home-based intervention program is delivered at home.
12053059|NCT00173082|Procedure|Glucose tolerance test|
12053060|NCT00173017|Device|wearing N95 masks|
12053061|NCT00172939|Procedure|foreskin from healthy adults|
12053062|NCT00172809|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 135 ug/week for 24 weeks
12053063|NCT00172809|Drug|Interferon alfa-2a|Interferon alfa-2a 3 MU tiw for 24 weeks
12053064|NCT00172653|Procedure|functional tasks|
12053065|NCT00172601|Procedure|mobilization|
12053066|NCT00172536|Behavioral|Exercise training|Subjects attended a supervised treadmill training session three times per week in an outpatient facility for three months. Training duration was 30 minutes per session, including a 5-minute warm-up and cool-down phase. Training intensity was initially set at about 60% of HR reserve and close to the anerobic threshold (AT) and the gradually increased as tolerated.
12053068|NCT00172510|Procedure|blood drawing|
12053137|NCT00171652|Drug|Diclofenac sodium gel 1%|
12053069|NCT00172484|Procedure|education program|A well-designed questionnaire concerning about awareness of stroke symptoms, knowledge, and management was done in adults of stroke victims' family members and general population.
12053070|NCT00172484|Procedure|nursing program|To establish a systemic stroke prevention, education protocol
12053071|NCT00172484|Procedure|rehabilitation program|From a sample of 648 stroke patients who were referred to rehabilitation between November 2002 and October 2002, 345 charts were successfully reviewed. Besides, 126 subjects were randomly selected and successfully contacted for telephone follow-up; and data from 87 subjects of telephone survey were included for statistical analysis. Comparison of functional status between early rehabilitation and ordinary scheduled rehabilitation for acute stroke patients was done from admission to 3 months after stroke onset. The efficacy of early application of electric stimulation for the upper paralyzed extremity was performed.
12053072|NCT00172445|Procedure|blood sampling, neck lymph node biopsy|
12053073|NCT00172419|Drug|Atorvastatin|Atorvastatin, 40 mg/day for 12 weeks
12053074|NCT00172380|Drug|Docetaxel Plus CDDP|docetaxel 36mg/m2 and cisplatin 75mg/m2
12053075|NCT00172367|Drug|Lycopene|
12053076|NCT00172354|Drug|Hydrocortisone|
12053077|NCT00172341|Drug|Staloral TM|
12053078|NCT00172328|Biological|Hepatitis B vaccine|
12053079|NCT00172302|Drug|vitamin C, intravenous injection|
12053080|NCT00172263|Procedure|blood sampling|
12053081|NCT00172211|Drug|Physioneal|
12053082|NCT00172198|Drug|Omegaven 10%|
12053083|NCT00172185|Drug|teduglutide 0.05 mg/kg/d|0.05 mg/kg/d subcutaneous injection
12053084|NCT00172185|Drug|teduglutide 0.10 mg/kg/d|0.10 mg/kg/d subcutaneous injection
12053085|NCT00172172|Drug|PTH/Calcium|PTH(1-84) subcutaneous injection and calcium 700 mg oral
12053086|NCT00172172|Drug|PTH/placebo|PTH (1-84) injected subcutaneously and placebo provided orally
12053087|NCT00172172|Drug|placebo|Placebo injected subcutaneously and 700 mg calcium orally
12053088|NCT00172159|Procedure|Hepatic resection|
12053089|NCT00172133|Drug|ALX1-11 (drug)|100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
12053090|NCT00172120|Drug|ALX1-11|
12053091|NCT00172107|Drug|ALX1-11 50 mcg|PTH(1-84) 50 mcg for subcutaneous injection into thigh or abdomen
12053092|NCT00172107|Drug|placebo|placebo powder for subcutaneous injection
12053093|NCT00172107|Drug|ALX1-11 75mcg|PTH(1-84)75 mcg for subcutaneous injection
12053094|NCT00172107|Drug|ALX1-11|PTH (1-84) 100mcg for subcutaneous injection into thigh or abdomen
12053095|NCT00172094|Drug|NPS 1776 (800 mg)|NPS 1776 (800 mg) powder
12053096|NCT00172094|Drug|PLACEBO|Placebo in non-carbonated fruit flavored drink (150 ml)
12053097|NCT00172094|Drug|NPS 1776 (400 mg)|NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
12053098|NCT00172081|Drug|placebo|Daily subcutaneous injection with placebo
12053099|NCT00172081|Drug|ALX1-11|PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen
12053100|NCT00172068|Drug|Zoledronic acid + Calcium/Vitamin D|
12053101|NCT00172055|Drug|Zoledronic acid|
12053102|NCT00172042|Drug|Zoledronic acid 4 mg|Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
12053103|NCT00172029|Drug|Zoledronic acid|
12053104|NCT00172016|Drug|Zoledronic acid|
12053105|NCT00172003|Drug|Zoledronic acid|
12053106|NCT00171990|Drug|Famciclovir|
12053107|NCT00171977|Drug|Imatinib Mesylate|
12053108|NCT00171964|Drug|Zoledronic acid in combination with therapy|
12053109|NCT00171951|Drug|Pasireotide|
12053110|NCT00171938|Drug|imatinib mesylate|
12053111|NCT00171925|Drug|Zoledronic acid|Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance > 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg*hr/l).
12053112|NCT00171925|Dietary Supplement|Calcium / Vitamin D|Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.
12053113|NCT00171912|Drug|imatinib mesylate|
12053114|NCT00171899|Drug|imatinib mesylate|
12053115|NCT00171886|Drug|Octreotide|
12053116|NCT00171873|Drug|Octreotide LAR (Long-acting release)|30 mg intramuscularly every 28 days
12053117|NCT00171873|Drug|Placebo|Sodium chloride intramuscularly every 28 days
12053118|NCT00171860|Drug|imatinib mesylate|
12053119|NCT00171847|Drug|Letrozole|
12053120|NCT00171847|Drug|Trastuzumab plus Letrozole|
12053121|NCT00171847|Drug|Letrozole|
12053122|NCT00171834|Drug|Patupilone|Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendment 2 and over 10 to 20 minutes (Amendment 2) till the completion of Phase I part of the study. Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks in Phase II part of the study.
12053123|NCT00171821|Drug|Deferasirox|
12053124|NCT00171808|Drug|Letrozole|
12053125|NCT00171795|Drug|Rivastigmine|
12053126|NCT00171782|Drug|VALSARTAN+HYDROCHLOROTHIAZIDE|
12053127|NCT00171769|Drug|Certoparin|
12053128|NCT00171756|Drug|valsartan/atenolol|
12053129|NCT00171743|Drug|Cyclosporine microemulsion|
12053130|NCT00171730|Drug|Pasireotide|
12053131|NCT00171717|Drug|Cyclosporine - cyclosporine microemulsion|
12053132|NCT00171704|Drug|Letrozole|2.5 mg tablets and supplied in bottles with 6-monthly supplies.
12053133|NCT00171704|Drug|Tamoxifen|20 mg tablets in bottles as 6-monthly supplies (supplied to Novartis as Tamofen from Schering Oy, Subsidiary of Schering AG, Pansiontie 47, FIN-2010 Turku, Finland)
12053134|NCT00171691|Drug|Diclofenac Topical Sodium Gel 1%|
12053135|NCT00171678|Drug|Diclofenac Topical Sodium Gel 1%|
12053136|NCT00171665|Drug|Diclofenac topical sodium gel 1%|
12053139|NCT00171626|Drug|Diclofenac Topical Sodium Gel 1%|
12053140|NCT00171613|Drug|Octreotide|
12053141|NCT00171600|Drug|VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ|
12053142|NCT00171587|Drug|PTK787/ZK 222584 (vatalanib)|
12053143|NCT00171574|Drug|Valsartan|
12053144|NCT00171574|Drug|Valsartan plus HCTZ|
12053145|NCT00171574|Drug|Lisinopril|
12053146|NCT00171561|Drug|valsartan/hydrochlorothiazide|
12053147|NCT00171535|Drug|valsartan/amlodipine|
12053148|NCT00171522|Drug|Tegaserod and Polyethylene Glycol 3350|
12053149|NCT00171509|Drug|Cyclosporine microemulsion|
12053150|NCT00171496|Drug|Cyclosporine microemulsion|
12053151|NCT00171496|Drug|Tacrolimus|
12053152|NCT00171483|Drug|Tegaserod|
12053153|NCT00171470|Drug|Tegaserod|
12053154|NCT00171457|Drug|Tegaserod|
12053155|NCT00171444|Behavioral|Medical education|
12053156|NCT00171431|Drug|Tegaserod|
12053157|NCT00171418|Drug|Tegaserod|
12053158|NCT00171405|Drug|aliskiren|
12053159|NCT00171392|Drug|Enteric-coated mycophenolate sodium|
12053160|NCT00171379|Drug|Enteric-Coated Mycophenolate Sodium|
12053161|NCT00171366|Drug|amlodipine/benazepril|
12053162|NCT00171353|Drug|valsartan|
12053163|NCT00171340|Drug|Zoledronic acid|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
12053164|NCT00171340|Drug|Letrozole|Letrozole tablets 2.5 mg/day taken orally for 5 years.
12053165|NCT00171327|Drug|valsartan, fluvastatin|
12053166|NCT00171314|Drug|Zoledronic acid|Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
12053167|NCT00171314|Drug|Letrozole|Letrozole tablets 2.5 mg/day/taken orally for 5 years.
12053168|NCT00171301|Drug|Deferasirox|Deferasirox was administered orally once daily. Deferasirox was available as 125 mg, 250 mg, and 500 mg tablets.
12053169|NCT00171288|Drug|fluvastatin, ezetimibe|
12053170|NCT00171275|Drug|Fluvastatin|
12053171|NCT00171262|Drug|Fluvastatin|
12053172|NCT00171249|Drug|imatinib mesylate|
12053173|NCT00171236|Drug|Fluvastatin|
12053174|NCT00171223|Drug|imatinib mesylate|
12053175|NCT00171210|Drug|Deferasirox|Tablets taken orally once a day.
12053176|NCT00171184|Drug|Darifenacin|Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
12053177|NCT00171184|Drug|Placebo|Placebo tablet once daily with sham titration
12053178|NCT00171171|Drug|deferasirox|
12053179|NCT00171158|Drug|imatinib mesylate|
12053180|NCT00171145|Drug|Darifenacin|Darifenacin 15 mg tablets once daily
12053181|NCT00171145|Drug|Placebo|Placebo tablets once daily
12053182|NCT00171132|Drug|valsartan|
12053183|NCT00171132|Drug|atenolol|
12053184|NCT00171132|Drug|hydrochlorothiazide|
12053185|NCT00171119|Drug|valsartan|
12053186|NCT00171106|Drug|valsartan|
12053187|NCT00171093|Drug|valsartan + simvastatin|
12053188|NCT00171080|Drug|valsartan|
12053189|NCT00171080|Drug|irbesartan|
12053190|NCT00171067|Drug|valsartan|
12053191|NCT00171067|Drug|lisinopril|
12053192|NCT00171054|Drug|Valsartan 320 mg|Patients received 160 mg valsartan for 4 weeks. Patients were then up-titrated to receive either 320 mg valsartan for the following 8 weeks.
12053193|NCT00171054|Drug|Amlodipine 10 mg|Patients received 5 mg amlodipine for four weeks. Patients were then up-titrated to receive 10 mg amlodipine for the following 8 weeks.
12053194|NCT00171054|Drug|Hydrochlorothiazide|At Week 12, patients who did not meet target Blood Pressure for both Systolic Blood Pressure < 140 mmHg and Diastolic Blood Pressure < 90 mmHg were eligible to receive 12.5 mg open-label Hydrochlorothiazide for the following 26 weeks.
12053195|NCT00171041|Drug|valsartan|
12053196|NCT00171028|Drug|valsartan|
12053197|NCT00171015|Drug|valsartan plus hydrochlorothiazide|
12053198|NCT00171002|Drug|valsartan/amlodipine|
12053199|NCT00170989|Drug|valsartan plus hydrochlorothiazide|
12053200|NCT00170976|Drug|valsartan + amlodipine|
12053201|NCT00170963|Drug|valsartan/amlodipine|
12053202|NCT00170950|Drug|Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1|Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.
12053203|NCT00170950|Drug|Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2|Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily.
12053204|NCT00170950|Drug|Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter|Benazepril hydrochloride (HCl)/amlodipine besylate: 40/10 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.
12053205|NCT00170950|Drug|Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily.
12053206|NCT00170950|Drug|Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily.
12053207|NCT00170950|Drug|Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/25 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.
12053208|NCT00170937|Drug|valsartan plus hydrochlorothiazide|
12053209|NCT00170924|Drug|Valsartan|
12053210|NCT00170911|Drug|AAE581|
12053211|NCT00170898|Drug|Lumiracoxib|
12053212|NCT00170885|Drug|Everolimus|
12053213|NCT00170872|Drug|Lumiracoxib|
12053214|NCT00170859|Drug|Everolimus|
12053215|NCT00170846|Drug|Everolimus (RAD001)|
12053216|NCT00170846|Drug|Calcineurin Inhibitors (CNI)|
12053217|NCT00170846|Drug|Mycophenolate acid (MPA)/Azathioprine (AZA)|
12053218|NCT00170846|Drug|Steroids|
12053219|NCT00170833|Drug|Everolimus|
12053220|NCT00170820|Drug|Everolimus|
12053221|NCT00170794|Drug|Everolimus (RAD001)|
12053222|NCT00170781|Drug|Lumiracoxib|
12053223|NCT00170768|Drug|Darifenacin|Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
12053224|NCT00170768|Drug|Oxybutynin|Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
12053225|NCT00170768|Drug|Placebo|Placebo once daily tablet (sham titration)
12053226|NCT00170755|Drug|Darifenacin|Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
12053227|NCT00170742|Drug|Octreotide, 30 mg i.m. LAR formulation|
12053228|NCT00170729|Drug|Prednisolone acetate|
12053229|NCT00170716|Device|Cortical Stimulation and rehabilitation|Cortical stimulation is provided concomitantly with rehabilitation therapy. Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
12053230|NCT00170716|Other|Rehabilitation|Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
12053231|NCT00170703|Device|Cortical Electrical Stimulation|
12053232|NCT00170690|Drug|Treosulfan|Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
12053233|NCT00170690|Drug|Treosulfan|Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
12053234|NCT00170677|Drug|Topotecan|Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
12053235|NCT00170677|Drug|Topotecan|Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
12053236|NCT00170664|Drug|Paclitaxel|
12053237|NCT00170664|Drug|Carboplatin|
12053238|NCT00170625|Drug|Hycamtin|Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d
12053239|NCT00170612|Biological|Pneumovax 23|23-valent PPS, 25 micrograms/serotype
12053240|NCT00170612|Biological|Prevnar|7-valent PCV, 2 micrograms/serotype, except serotype 6B which is 4 micrograms/serotype
12053241|NCT00170586|Device|Underglove coating (skin barrier)|
12053242|NCT00170573|Drug|Caelyx|Caelyx 40 mg/ m2biweekly
12053243|NCT00170547|Biological|Trivalent inactivated influenza vaccine|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0
12053244|NCT00170547|Biological|Trivalent inactivated influenza vaccine|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
12053245|NCT00170547|Biological|Trivalent inactivated influenza vaccine|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.
12053246|NCT00170534|Behavioral|Behavior|
12053247|NCT00170508|Biological|Fluzone®|
12053248|NCT00170469|Biological|AVA|
12053249|NCT00170469|Biological|rPA vaccine containing alhydrogel|
12053250|NCT00170456|Biological|rPA vaccine containing alhydrogel|
12053251|NCT00170443|Biological|rHAO Trivalent Influenza Vaccine|
12053252|NCT00170430|Drug|Fluconazole|
12053253|NCT00170430|Drug|Metronizadole|
12053254|NCT00170417|Behavioral|Cognitive Behaviour Therapy|
12053255|NCT00170404|Drug|Folic Acid|
12053256|NCT00170404|Drug|Micronutrients: Vitamins B1, B2, B6, Niacin, B12, C, E.|
12053257|NCT00170404|Drug|Selenium|
12053258|NCT00170404|Drug|Vitamin A|
12053259|NCT00170391|Behavioral|Quarter of an Hour rule|
12053260|NCT00170378|Drug|Enoxaparin|
12053261|NCT00170365|Behavioral|Restorative Yoga|
12053262|NCT00170352|Procedure|Hyperbaric Oxygen Treatment (HBOT)|
12053263|NCT00170352|Procedure|Enhanced Oxygen Treatment (Enhanced FiO2)|
12053264|NCT00170326|Procedure|dual-chamber pacemaker implantation|Dual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device.
12053265|NCT00170326|Procedure|biventricular dual-chamber pacemaker implant|Biventricular pacemaker system or in case in ICD indication a BIV ICD
12053266|NCT00170313|Device|Conducted AF-Response Algorithm (CAFR) On|Algorithm will be enabled.
12053267|NCT00170313|Device|Conducted AF-Response Algorithm (CAFR) Off|Algorithm will be disabled.
12053268|NCT00170300|Device|Implantable Cardiac Resynchronisation (pacing) device|
12053269|NCT00170287|Procedure|ICD Ablation plus VT-ablation|ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
12053270|NCT00170287|Device|ICD Therapy|ICD Therapy for the Treatment of unstable VT´s
12053271|NCT00170274|Device|Activation of preventive and therapeutic algorithms for treatment of AF|Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation
12053272|NCT00170274|Device|AF Prevention and Therapy Algorithms On|Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm
12053273|NCT00170261|Device|Use of an Implantable Loop Recorder|
12053274|NCT00170248|Device|computer-based decision support for asthma management|The asthma management decision support system uses data from the patient problem and medication list to provide patient-specific management recommendations based on Canadian Consensus guidelines for asthma management. Web-enabled technology for asthma education nurses is used to collect home-monitoring information from patients between visits and feedback to primary care physicians in accordance with options selected by the physician for each patient.
12053275|NCT00170235|Other|Prehabilitation|Exercise class pre-surgery
12053276|NCT00170235|Other|Usual care|Exercise booklet, physiotherapy if needed
12053277|NCT00170222|Drug|doxycycline|
12053278|NCT00170209|Drug|Isoniazid|The dosage of the medication is determined according to the weight of the child. The dose is once per day, 10-15 mg/kg/day (max=300mg/day). Total duration of treatment is 9 months. Both a detailed dose chart calculating doses by weight and age and protocols for preparation of medications (crushing pills, mixing suspensions) are available.
12053325|NCT00169676|Other|observation|registry and database for surgery outcomes
12053478|NCT00168493|Drug|antidepressants primarily selective serotonin reuptake inhibitors|normal clinical dosages used according to clinical response as determined by a psychiatrist
12053279|NCT00170209|Drug|Rifampin|The dosage of the medication is determined according to the weight of the child. The dose is once per day, 10-20 mg/kg/day (max=600mg/day). Total duration of treatment is 4 months. Both a detailed dose chart calculating doses by weight and age and protocols for preparation of medications (crushing pills, mixing suspensions) are available.
12053280|NCT00170196|Drug|prednisone|
12053281|NCT00170183|Drug|Nesiritide|
12053282|NCT00170157|Drug|Bicalutamide|Given orally
12053283|NCT00170157|Drug|Flutamide|Given orally
12053284|NCT00170157|Drug|Goserelin Acetate|Given SC
12053285|NCT00170157|Drug|Ipilimumab|Given IV
12053286|NCT00170157|Drug|Leuprolide Acetate|Given IM
12053287|NCT00170157|Other|Pharmacological Study|Correlative study
12053288|NCT00170144|Drug|Branchamin 4%|
12053289|NCT00170118|Behavioral|motivational interviewing|
12053290|NCT00170079|Behavioral|Smoking Cessation Intervention|"A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:
~Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;
~Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and
~Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition."
12053291|NCT00170053|Drug|Sirolimus|10 mg oral loading dose followed by 5 mg/day. Measure Sirolimus level weekly and adjust to level of 10-15 ng/ml.
12053292|NCT00170027|Device|Magnetocardiograph|
12053293|NCT00170014|Device|Magnetocardiograph|
12053294|NCT00170001|Drug|Nexium|40 mg bid dosing
12053295|NCT00170001|Drug|Sugar Pill|40 mg BID
12053296|NCT00169988|Drug|risperidone|
12053297|NCT00169988|Drug|sertraline-primary|
12053298|NCT00169975|Device|Magnetocardiograph|MCG and ECG recordings sequentially at the four pre-defined bed positions and watches the real-time magnetocardiogram traces on the computer screen. At each position, nine sensors record MCG data, thus forming a 3 x 3 point grid square with point-to-point separation of 40 mm. The number of cardiac cycles recorded at each position should be adequate for signal averaging. Recording time per position is typically 90 seconds. At the end of 4 sequential recordings, raw, unfiltered MCG data are stored.
12053299|NCT00169962|Drug|rhDNAse (pulmozyme)|
12053300|NCT00169949|Drug|aripiprazole|
12053301|NCT00169936|Device|Magnetocardiograph|
12053302|NCT00169923|Drug|rosiglitazone|
12053303|NCT00169910|Drug|AUC monitored withdrawal of MMF or CNI|AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients
12053304|NCT00169897|Behavioral|Pulmonary rehabilitation (teaching and exercise)|After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study.
12053305|NCT00169884|Behavioral|cognitive-behavioural therapy|
12053306|NCT00169858|Biological|Engerix-B|10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.
12053307|NCT00169845|Dietary Supplement|Alpha-Tocopherol and Beta-Carotene|Provided by Roche Vitamins Inc.
12053308|NCT00169845|Dietary Supplement|Placebo|Provided by Roche Vitamins Inc
12053309|NCT00169832|Drug|Rosiglitazone or placebo|Rosiglitazone 4 to 8 mg/day or placebo, for 12 months
12053310|NCT00169819|Drug|Abciximab|
12053311|NCT00169806|Other|videotape for mapping of renal anatomy and papillary biopsy|Subjects who enroll in this study will have their renal anatomy videotaped for mapping purposes. Stone location and characteristics will be documented as will papilla and calyces. One or more papillary biopsies will be taken for analysis.
12053312|NCT00169793|Other|evaluation of kidney stone risk after bariatric surgery|24 hour urine collections done pre and post surgery
12053313|NCT00169793|Other|Evaluate risk of kidney stones after bariatric surgery|24 hour urine collections are done before and after surgery
12053314|NCT00169780|Radiation|High definition helical CT (64 head scanner)|"Patients who require a CT scan for diagnostic purposes prior to kidney stone surgery will undergo a high definition helical CT rather than the standard CT scan. This high resolution scan will then be reviewed by the researchers to help determine the type of treatment needed for the kidney stone removal. The aim is to see if the higher resolution will show more of the stone anatomy which will help the surgeon determine if the stone will be amenable to shock wave lithotripsy or if another type of treatment would best serve the patient needs."
12053315|NCT00169767|Other|Comparison study between KTP and HoLAP for BPH|Comparison study between KTP and HoLAp for BPH
12053316|NCT00169754|Other|mapping kidney anatomy|videotape of surgical procedure to document location of attached stones and condition of calyces and papilla.
12053317|NCT00169741|Other|Renogram|Subjects who enroll in this study will undergo a nuclear scan called a renogram to assess renal function prior to surgery (baseline), approximately one hour after surgery (to assess percutaneous effects on renal function) and finally approximately 6 weeks post-operatively (to assess return to baseline).
12053318|NCT00169728|Biological|DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa|
12053319|NCT00169728|Biological|heptavalent pneumococcal conjugate vaccine, Prevenar|
12053320|NCT00169715|Procedure|Percutaneous Caliceal Diverticuli|Standard of care to remove a stone from a caliceal diverticulum is to do a percutaneous procedure for stone removal and then fulgerate the diverticulum to prevent stone recurrence. We plan to aspirate urine from this diverticulum and compare it to urine collected from the renal pelvis of the same kidney.
12053321|NCT00169702|Behavioral|weight management program|12 sessions, psychoeducation
12053322|NCT00169702|Behavioral|weight management program|2 weekly, 12 sessions, psychoeducational weight management
12053323|NCT00169689|Procedure|"rTMS, repetitive transcranial magnetic stimulation"|10 Hz rTMS (10.000 stimuli) over left dorsolateral prefrontal cortex
12053324|NCT00169689|Other|rTMS|repetitive transcranial magnetic stimulation, 10 Hz, 10.000 stimuli, 2 weeks
12053326|NCT00169650|Other|Registry and database|Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction at Methodist Urology in Indiana will be asked to participate in a registry and database to review outcomes of the surgery.
12053327|NCT00169637|Drug|rhGH|
12053328|NCT00169624|Drug|Metformin|
12053329|NCT00169624|Drug|Gliclazide|
12053330|NCT00169611|Drug|methylphenidate|
12053331|NCT00169598|Procedure|positron emission tomography|
12053332|NCT00169585|Drug|Levofloxacin oral tablets|
12053333|NCT00169572|Drug|Aprepitant|
12053334|NCT00169572|Drug|Ondansetron|
12053335|NCT00169572|Drug|GW679769|
12053336|NCT00169572|Drug|Dexamethasone|
12053337|NCT00169559|Drug|GW590735|1µg to 20µg daily doses of GW590735
12053338|NCT00169559|Drug|fenofibrate|Marketed Drug
12053339|NCT00169546|Drug|Salmeterol/fluticasone propionate|
12053340|NCT00169546|Drug|Fluticasone propionate|
12053341|NCT00169533|Drug|GW572016 oral tablets|Lapatinib either at 750, 1000, 1250 or 1500 mgs
12053342|NCT00169520|Drug|docetaxel|
12053343|NCT00169520|Drug|SB-715992|
12053344|NCT00169507|Biological|Pneumococcal (vaccine)|
12053345|NCT00169494|Biological|HPV-16/18 L1/AS04|
12053346|NCT00169481|Biological|Pneumococcal (vaccine)|
12053347|NCT00169468|Drug|Rituximab -CHOP plus Velcade|
12053348|NCT00169455|Biological|Live attenuated human rotavirus vaccine|
12053349|NCT00169442|Biological|Tritanrix™-HepB/Hiberix™ Kft.|GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.
12053350|NCT00169442|Biological|Tritanrix™-HepB/Hiberix™|GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
12053351|NCT00169442|Biological|Hiberix™|GSK Biologicals' Haemophilus influenzae type b vaccine
12053352|NCT00169442|Biological|Polyribosil-Ribitol-Phosphate (PRP) vaccine|plain PRP polysaccharide vaccine
12053353|NCT00169442|Biological|Tritanrix™-HepB Kft|GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.
12053354|NCT00169416|Drug|valaciclovir HCl granules|
12053355|NCT00169403|Procedure|Deep brain stimulation|
12053356|NCT00169377|Procedure|deep brain stimulation|Stimulator on followed by off
12053357|NCT00169377|Procedure|No stimulation|Stimulator off followed by on
12053358|NCT00169364|Device|positron emission tomography|
12053359|NCT00169338|Procedure|Deep brain stimulation|internal pallidal deep brain stimulation
12053360|NCT00169325|Procedure|Magnetic resonance imaging|
12053361|NCT00169312|Behavioral|behavioral dietary intervention|
12053362|NCT00169312|Dietary Supplement|dietary intervention|
12053363|NCT00169312|Other|educational intervention|
12053364|NCT00169312|Other|internet-based intervention|
12053365|NCT00169312|Other|preventative dietary intervention|
12053366|NCT00169312|Procedure|evaluation of cancer risk factors|
12053367|NCT00169299|Drug|Black cohosh|
12053368|NCT00169299|Drug|Multibotanical preparation|
12053369|NCT00169299|Drug|Multibotanical preparation + dietary soy counseling|
12053370|NCT00169299|Drug|Conjugated equine estrogen +/- medroxyprogesterone acetate|
12053371|NCT00169286|Procedure|Telephone care management|
12053372|NCT00169286|Procedure|peer-led chronic disease self-management workshop|
12053373|NCT00169286|Procedure|professionally-led cognitive behavioral psychotherapy group|
12053374|NCT00169273|Behavioral|Structured behavioral weight loss group|Structured group weight loss program
12053375|NCT00169273|Behavioral|Weight loss and cognitive-behavioral depression group|Structured group program for weight loss and depression
12053376|NCT00169260|Behavioral|motivational counseling|behavioral motivational counselling
12053377|NCT00169260|Behavioral|placebo|
12053378|NCT00169247|Drug|cetuximab|
12053379|NCT00169247|Drug|Cisplatin|
12053380|NCT00169247|Procedure|Radiotherapy 70 Gy, 35 fractions|
12053381|NCT00169234|Biological|PCV7, Prevnar®|Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
12053382|NCT00169234|Biological|Pneumovax 23|Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
12053383|NCT00169221|Drug|Iressa (Gefitinib)|postoperative chemoradiotherapy with cisplatin + gefitinib
12053384|NCT00169221|Radiation|chemoradiotherapy with cisplatin|postoperative chemoradiotherapy with cisplatin
12053385|NCT00169208|Drug|rituximab|375 mg/m² IV, D1 each cycle during 4 cycles
12053386|NCT00169208|Drug|fludarabine|40 mg/m²/day IV , D1 each cycle during 4 cycles
12053387|NCT00169208|Drug|mitoxantrone|10 mg/m² IV, D2-3-4 each cycle during 4 cycles
12053388|NCT00169195|Drug|Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)|
12053389|NCT00169182|Drug|DOCETAXEL|75 mg/m 2 on day 1
12053390|NCT00169182|Drug|Cisplatin|75 mg/m 2 on day 1
12053391|NCT00169182|Drug|5-Fluoro-3-Pyridinecarboxylic Acid|750 mg/m 2 by 24-hour continuous infusion for 5 days
12053392|NCT00169169|Drug|ACVBP|
12053393|NCT00169169|Drug|ACE|
12053394|NCT00169169|Drug|rituximab|
12053395|NCT00169169|Procedure|Autologous stem cell transplant|
12053396|NCT00169156|Drug|Rituximab|375 mg/m2 D1
12053397|NCT00169156|Drug|Prednisone|40 mg/m2 D1 to D5
12053398|NCT00169156|Drug|Doxorubicine|50 mg/m2 D1
12053399|NCT00169156|Drug|Cyclophosphamide|750 mg/m2 D1
12053400|NCT00169156|Drug|Vincristine|1,4 mg/m2 D1
12053401|NCT00169143|Drug|Rituximab + ACVBP regimen plus Pegfilgrastim|
12053402|NCT00169143|Procedure|Autologous stem cell transplant|
12053403|NCT00169130|Drug|doxorubicin|
12053404|NCT00169130|Drug|cyclophosphamide|
12053405|NCT00169130|Procedure|Autologous stem cell transplantation|
12053406|NCT00169117|Behavioral|Songs/posters aimed at behaviour change|This was a behavioural intervention, using songs and posters composed/designed by community members which aimed at behaviour change to increase repair and maintenance of mosquito nets
12053407|NCT00169104|Drug|G-CSF|5 mcgm/kg daily Monday through Friday weeks 3-14
12053408|NCT00169104|Drug|trastuzumab|4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14
12053409|NCT00169104|Drug|vinorelbine|25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13
12053410|NCT00169104|Drug|G-CSF|5 mcgm/kg SQ daily for ten days, Monday through Friday of the first two weeks of the study
12053411|NCT00169104|Drug|saline placebo|Saline will be given SQ daily for ten days, Monday through Friday of the first two weeks of the study
12053412|NCT00169091|Drug|Clozapine|Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 12.5 mg on Day 1 to up to 300 mg on Day 12.
12053413|NCT00169091|Drug|Haloperidol|Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 2 mg on Day 1 to up to 12 mg on Day 12.
12053414|NCT00169078|Drug|Chloroquine|
12053415|NCT00169065|Drug|Clozapine|
12053416|NCT00169065|Drug|Olanzapine|
12053417|NCT00169052|Behavioral|Health Care Management and Supported Rehabilitation|
12053418|NCT00169039|Drug|Clozapine|
12053419|NCT00169039|Drug|Chlorpromazine|
12053420|NCT00169026|Drug|Clozapine versus typical (conventional) and atypical antipsychotic medications|
12053421|NCT00169013|Drug|Gabapentin|
12053422|NCT00169000|Drug|Capecitabine|"Capecitabine at the following dose levels for 14 days every 21 days, beginning with dose level 1
~Dose level -2 600 mg/m2 po BID
~Dose level -1 700 mg/m2 po BID
~Dose level 1 825 mg/m2 po BID
~Dose level 2 1000 mg/m2 po BID"
12053423|NCT00169000|Drug|Docetaxel|75 mg/m2 over one hour on day 8 of each cycle
12053424|NCT00168987|Drug|oral nutritional supplement rich in eicosapentanoic acid|
12053425|NCT00168961|Dietary Supplement|High Protein Energy, Fresenius-Kabi (nutritional intervention)|
12053426|NCT00168948|Drug|Sulfadoxin (12.5) Pyrimethamine (250 mg)|
12053427|NCT00168935|Drug|Fresubin protein energy Drink (CAVE! nutritional intervention)|
12053428|NCT00168922|Drug|Bendamustin/Ribomustin|
12053429|NCT00168909|Drug|alfacalcidol|alfacalcidol 1 µg once daily, oral, for 3 years
12053430|NCT00168909|Drug|placebo|placebo once daily, oral, for 3 years
12053431|NCT00168896|Drug|Carboplatin plus Irinotecan vs Carboplatin plus Etoposide|
12053432|NCT00168883|Drug|Carboplatin|
12053433|NCT00168883|Drug|Paclitaxel|
12053434|NCT00168883|Drug|Vinorelbine|
12053435|NCT00168870|Drug|Gemcitabine|
12053436|NCT00168870|Drug|Treosulfan|
12053437|NCT00168857|Drug|telmisartan|
12053438|NCT00168857|Drug|losartan|
12053439|NCT00168844|Drug|Tiotropium Inhalation Solution|
12053440|NCT00168844|Other|Placebo|
12053441|NCT00168831|Drug|Tiotropium Inhalation Solution|
12053442|NCT00168831|Other|Placebo|
12053443|NCT00168818|Drug|dabigatran etexilate|daily dose 150 mg once daily, half a dose on the day of surgery
12053444|NCT00168818|Drug|dabigatran etexilate|daily dose 150 mg once daily, half a dose on the day of surgery
12053445|NCT00168818|Drug|enoxaparin|40 mg once daily
12053446|NCT00168805|Drug|enoxaparin|40 mg once daily
12053447|NCT00168805|Drug|dabigatran etexilate|150 mg once daily
12053448|NCT00168805|Drug|dabigatran etexilate|220 mg once daily
12053449|NCT00168792|Drug|Tenecteplase|
12053450|NCT00168792|Procedure|PCI|
12053451|NCT00168779|Drug|telmisartan 80 mg / hydrochlorothiazide 25 mg|
12053452|NCT00168779|Drug|valsartan 160 mg / hydrochlorothiazide 25 mg|
12053453|NCT00168779|Drug|placebo|
12053454|NCT00168766|Drug|Interferon-beta-1a (Avonex) plus methylprednisolone|oral administration given on 3 consecutive days, monthly as described in protocol.
12053455|NCT00168753|Drug|Alefacept|IM
12053456|NCT00168740|Drug|rituximab|
12053457|NCT00168727|Drug|ibritumomab tiuxetan (Zevalin®)|
12053458|NCT00168714|Drug|BG9418 (interferon beta-1a)|Exposure to Avonex during pregnancy
12053459|NCT00168701|Drug|BG00012|
12053460|NCT00168688|Dietary Supplement|multi micronutrient supplement|
12053461|NCT00168688|Dietary Supplement|MN1|Vitamin A 800 μg RE, Vitamin D 200 IU, Vitamin E 10 mg, Vitamin B1 1.4 mg, Vitamin B2 1.4 mg, Niacin 18 mg, Folic acid 400 μg, Vitamin B6 1.9 mg, Vitamin B12 2.6 μg, Vitamin C 70 mg, Zinc 15 mg, Iron 30 mg, Copper 2.0 mg, Selenium 65 μg, Iodine 150 μg
12053462|NCT00168688|Dietary Supplement|MN2|Vitamin A 1600 μg RE, Vitamin D 400 IU, Vitamin E 20 mg, Vitamin B1 2.8 mg, Vitamin B2 2.8 mg, Niacin 36 mg, Folic acid 800 μg, Vitamin B6 3.8 mg, Vitamin B12 5.2 μg, Vitamin C 140 mg, Zinc 30 mg, Iron 30 mg, Copper 4.0 mg, Selenium 130 μg, Iodine 300 μg
12053463|NCT00168662|Biological|Measles and inactivated polio vaccine|
12053464|NCT00168649|Drug|Vitamin A|
12053465|NCT00168636|Drug|Vitamin A|
12053466|NCT00168623|Drug|Vitamin A|
12053467|NCT00168610|Drug|Vitamin A|
12053468|NCT00168597|Drug|Vitamin A|
12053469|NCT00168584|Drug|Vitamin A|
12053470|NCT00168571|Biological|Measles vaccine|
12053471|NCT00168558|Biological|Measles vaccine|"The children will be randomised to the following three arms:
~Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age.
~Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age.
~Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age.
~V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine"
12053472|NCT00168545|Biological|Measles vaccine|
12053473|NCT00168532|Drug|Sulfamethoxazole-Trimethoprim|
12053474|NCT00168519|Drug|nitroprusside, pentalong, imdur, AICAR, isoptin|"Sodium Nitroprusside - one 30 minute intravenous infusion
~Pentalong - two tablets orally (total 160mg)
~Imdur - two tablets orally (total 120mg)"
12053475|NCT00168506|Drug|SSRI|
12053476|NCT00168506|Drug|CBT|
12053477|NCT00168506|Drug|CBT/SSRI|
12053479|NCT00168480|Biological|Botulinum Toxin Type A|100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period
12053480|NCT00168467|Drug|Ramipril|
12053481|NCT00168454|Biological|botulinum toxin Type A|botulinum toxin Type A injected into detrusor on Day 1
12053482|NCT00168454|Drug|Placebo|Placebo (normal saline) injected into detrusor on Day 1
12053483|NCT00168441|Drug|Botulinum Toxin Type A|
12053484|NCT00168428|Biological|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
12053485|NCT00168428|Other|placebo (saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
12053486|NCT00168415|Biological|Botulinum Toxin Type A|100 U up to 6 times during the study depending on the response to treatment
12053487|NCT00168402|Drug|Botulinum Toxin Type A|
12053488|NCT00168389|Drug|Dexamethasone|350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
12053489|NCT00168389|Other|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
12053490|NCT00168376|Device|Transcranial Magnetic Stimulation|
12053491|NCT00168363|Drug|brimonidine|
12053492|NCT00168350|Drug|memantine|
12053493|NCT00168337|Drug|Dexamethasone|350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
12053494|NCT00168337|Other|Sham|Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
12053495|NCT00168324|Drug|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
12053496|NCT00168324|Drug|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
12053497|NCT00168324|Other|Sham Injection|Sham injection on Day 0.
12053498|NCT00168311|Device|Transcranial Magnetic Stimulation|Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week.
12053499|NCT00168311|Device|sham TMS|
12053500|NCT00168298|Drug|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
12053501|NCT00168298|Drug|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
12053502|NCT00168298|Other|Sham Injection|Sham injection on Day 0.
12053503|NCT00168285|Behavioral|Pulmonary Rehabilitation|
12053504|NCT00168272|Device|Transcranial Magnetic Stimulation|
12053505|NCT00168181|Procedure|Submandibular gland Transfer|
12053506|NCT00168181|Drug|Salagen|
12053507|NCT00168168|Drug|G-CSF/Filgrastim|
12053508|NCT00168155|Drug|perioperative chemotherapy|
12053509|NCT00168129|Procedure|Helical tomotherapy|
12053510|NCT00168116|Procedure|radiation treatment and surgery|
12053511|NCT00168116|Procedure|radiation alone|
12053512|NCT00168103|Biological|C1 Esterase Inhibitor|Single application of C1-INH administered intravenously by slow injection or infusion at a recommended rate of 4mL/min.
12053513|NCT00168103|Biological|Placebo|Single application of physiological saline solution equivalent to the volume calculated for subjects in the C1-INH 20 U/kg bw arm.
12053514|NCT00168090|Drug|Blood coagulation Factor VIII and vWF, human|
12053515|NCT00168077|Drug|Prothrombin Complex Concentrate|
12053516|NCT00168064|Drug|mechlorethamine-MCH (nitrogen mustard)|All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
12053517|NCT00168051|Drug|ReFacto|
12053518|NCT00168051|Drug|Advante|
12053519|NCT00168038|Biological|Immunoglobulin Intravenous (Human)|A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.
12053520|NCT00168025|Drug|Immunoglobulins Intravenous (Human)|
12053521|NCT00168012|Drug|Immunoglobulins Intravenous (Human)|
12053522|NCT00167999|Drug|piperacillin-tazobactam|
12053523|NCT00167986|Drug|vancomycin-resistant enterococci and ESBL|
12053524|NCT00167960|Drug|Piperacillin/tazobactam and other β-lactam/β-lactamase|
12053525|NCT00167947|Drug|Cyclosporine|"Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
12053526|NCT00167947|Drug|Steroids|"Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
12053527|NCT00167947|Drug|Rapamune (Sirolimus)|"Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
12053528|NCT00167934|Drug|Valproate|Depakote ER 500 mg to 3000 mg taken every night
12053529|NCT00167934|Drug|Placebo|Placebo given at same frequency as Valproate
12053530|NCT00167921|Drug|Premarin® Vaginal Cream|
12053531|NCT00167921|Drug|Premarin® oral tablets|
12053532|NCT00167908|Drug|Ethyol (drug)|
12053533|NCT00167895|Procedure|Adding platelet concentrate to the wound|
12053534|NCT00167882|Drug|5-aminosalicylate (Pentasa, Ferring)|
12053535|NCT00167869|Behavioral|dairy peptides|
12053536|NCT00167856|Drug|Venalafaxine hydrochloride|Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
12053537|NCT00167843|Drug|sulfadoxine-pyrimethamine|
12053538|NCT00167830|Behavioral|Motivational Interviewing|Biweekly meetings with a behavior specialist to review subject's progress with the protocol and explore challenges subject is facing in adopting healthy lifestyle behaviors.
12053589|NCT00167388|Other|feed during blood transfusion|babies receiving the intervention are fed during the PRBC transfusion
12053539|NCT00167830|Behavioral|Strength and Cardiovascular Conditioning|Subjects take part in an exercise program to include 30 minutes of cardiorespiratory exercise at 70% maximum heart rate, and 30 minutes of strength training on Nautilus machines.
12053540|NCT00167830|Behavioral|Food selection and portion control|Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.
12053541|NCT00167817|Drug|Aripiprazole|
12053542|NCT00167804|Behavioral|Virtual Reality Exposure|VRE uses computer generated environments to conduct exposure therapy.
12053543|NCT00167791|Drug|rituximab|Rituximab 375mg/m2 IV weekly times 4 weeks
12053544|NCT00167778|Device|Transverse plane rotation adaptor pylon|Potential future practice
12053545|NCT00167778|Device|Rigid pylon|Current clinical practice
12053546|NCT00167765|Drug|Abciximab|
12053547|NCT00167739|Drug|Quinine plus sulfadoxine-pyrimethamine|
12053548|NCT00167713|Drug|Ibuprofen|
12053549|NCT00167700|Behavioral|Dietary counselling and placebo|Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Placebo capsules.
12053550|NCT00167700|Behavioral|Dietary counselling and probiotics|Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Probiotics
12053551|NCT00167700|Dietary Supplement|Placebo capsules|Placebo capsules
12053552|NCT00167700|Dietary Supplement|Probiotics|
12053553|NCT00167700|Dietary Supplement|Prebiotics|
12053554|NCT00167687|Drug|prazosin|"Pharmacological treatment: In order to prevent the possible side effect of first-dose hypotension, all participants will receive only 1mg of study medication or placebo nightly for the first two days of study participation. Titration will proceed according to the following schedule:
~Prazosin Dosing: 9 AM 3 PM 9 PM Days 1-2 1 mg (one capsule) Days 3-4 1 mg 1 mg 1 mg Days 5-7 2 mg 2 mg 2 mg Day 8-10 2 mg 2 mg 6 mg Day 11-14 4 mg 4 mg 6 mg Day 15-42 4 mg 4 mg 8 mg"
12053555|NCT00167674|Drug|Combined short-course zidovudine/nevirapine|300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight > 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours of delivery.
12053556|NCT00167674|Drug|HAART|300 mg of zidovudine (ZDV), 150 mg of lamivudine, and 200 mg nevirapine (NVP) was given twice daily from 34 weeks gestation until six months after delivery.
12053557|NCT00167661|Drug|Campath-1H|two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
12053558|NCT00167648|Drug|Leuprolide or goserelin|Leuprolide 7.5 mg (4-week depot) or goserelin 3.6 mg (4-week depot)
12053559|NCT00167648|Drug|Transdermal estradiol|Estradiol patches, six at 0.1 mg each, changed every 3-4 days
12053560|NCT00167635|Behavioral|cognitive-behavioral|Cognitive-behavioral over 9 weeks
12053561|NCT00167622|Procedure|mechanical ventilation|Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation
12053562|NCT00167622|Procedure|physiotherapy and oxygen if needed|oxygen will be delivered via facial mask whenever needed and physiotherapy
12053563|NCT00167609|Drug|dehydroepiandrosterone 100 and 400 mg|
12053564|NCT00167596|Device|Near Infrared Spectroscopy|resuscitation will be based on Surviving Sepsis Campaign guidelines AND on increasing StO2 to 80% or more in at least 2 out of the 3 following sites: thenar, masseter and deltoid
12053565|NCT00167596|Device|conventional|resuscitation will be based according to Surviving Sepsis Campaign
12053566|NCT00167583|Drug|Cyclosporin A|3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
12053567|NCT00167583|Drug|Interferon-alpha2a|3-6 million iU per day sc., augmented to up to 9 if necessary, later reduced (according to clinical response) to 3 x 3 million iU /week.
12053568|NCT00167570|Device|Prosthetic socket fabricated using selective laser sintering|
12053569|NCT00167557|Drug|Pegylated Interferon|180mcg SC weekly starting 30 days post transplant
12053570|NCT00167557|Drug|Ribavirin|goal dose 13mg/kg starting 120 days post transplant for a minimum of 48 wks
12053571|NCT00167557|Procedure|Liver Biopsy|Liver biopsies performed at 9 points in time from time of liver transplant
12053572|NCT00167544|Drug|Hydrocortisone|Hydrocortisone 3 mg/kg/d divided q 12h IV/PO tapered over 7 days
12053573|NCT00167544|Drug|Placebo|Saline
12053574|NCT00167531|Behavioral|treadmill walking with partial weight support|
12053575|NCT00167531|Behavioral|assisted overground walking|30 minutes per day of overground walking with the assistance of one therapist
12053576|NCT00167518|Drug|Triamcinolone acetate|
12053577|NCT00167505|Behavioral|Risk Avoidance Intervention|The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
12053578|NCT00167505|Behavioral|Risk Reduction Intervention|The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
12053579|NCT00167492|Drug|Myfortic|720 mg by mouth every 12 hours
12053580|NCT00167479|Drug|risperidone (Risperdal)|
12053581|NCT00167466|Device|Soladey-3 toothbrush|subject to brush with experimental Soladey-3 brush for 4 week
12053582|NCT00167466|Device|Placebo Soladey-3 toothbrush|subjects will brush with placebo Soladey-3 toothbrush for 4 weeks
12053583|NCT00167453|Procedure|Exercise, Education|
12053584|NCT00167414|Procedure|Hypofractionated Stereotactic Body Radiation Therapy|Hypofractionated Stereotactic Body Radiation Therapy
12053585|NCT00167414|Radiation|Hypofractionated Stereotactic Body Radiation Therapy|Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
12053586|NCT00167401|Drug|docetaxel|
12053587|NCT00167401|Drug|cisplatin|
12053588|NCT00167401|Procedure|radiation treatment|
12053590|NCT00167375|Drug|eszopiclone 3 mg qHS|
12053591|NCT00167375|Behavioral|General cognitive/behavioral interventions for insomnia|
12053592|NCT00167362|Behavioral|Cognitive enhancement therapy (CET)|Using 80 to 100 hours of graduated exercises in computer assisted training, coupled with structured but unrehearsed in vivo social group interactions, CET tries to shift an early developmental reliance on effortful, serial and verbatim cognitive processing to a more gistful, less effortful and spontaneous abstraction of social themes. CET uses attention, memory and problem solving software from three exercises from Ben-Yishay's Orientation Remediation Module (the Attention Reaction Conditioner, Zero Accuracy Conditioner, and Time Estimates) that are graduated in difficulty and designed to enhance vigilance, selective attention, the ability to shift between auditory and visual modalities, and rapid decision-making.
12053593|NCT00167362|Behavioral|Enriched supportive therapy (EST)|EST is the commonly recommended (Spaulding 1992) treatment for control and experimental subjects in psychosocial trials. EST is a two-staged treatment that requires weekly one-hour sessions in Phase 1 and biweekly sessions in Phase 2. Some practice principles (e.g., psychoeducation and relaxation training) are provided during the group exercises for CET patients, but individually for EST patients. No attempt is made to control for hours of contact between EST and CET, since offering three hours of supportive therapy to EST subjects is neither logistically feasible nor faithful to the goals and methods of supportive therapy. Further, neurobiological hypotheses related to treatment specificity would be best tested by clear differences in treatment intensity and content.
12053594|NCT00167323|Behavioral|Adherence therapy|
12053595|NCT00167310|Drug|Eicosapentaenoic acid (omega-3 fatty acid)|2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
12053596|NCT00167310|Drug|Placebo|2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
12053597|NCT00167297|Drug|Atomoxetine|
12053598|NCT00167284|Behavioral|physician and patient education; physician practice redesign|
12053599|NCT00167271|Behavioral|Cognitive Behavior Therapy|Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
12053600|NCT00167258|Behavioral|Voucher Reinforcement|
12053601|NCT00167258|Behavioral|Extra Counseling Services|
12053602|NCT00167258|Behavioral|Voucher Reinforcement + Extra Counseling Services|
12053603|NCT00167245|Drug|Topiramate|300mg/day for 13 weeks
12053604|NCT00167245|Drug|placebo|placebo pills
12053605|NCT00167232|Drug|Naltrexone|
12053606|NCT00167219|Biological|Stem Cell Transplant|Transplantation on Day 0.
12053607|NCT00167219|Drug|Preparative Regimen|"Busulfan
~Cyclophosphamide
~Mesna
~Melphalan
~Anti-thymocyte Globulin (ATG)"
12053608|NCT00167206|Procedure|Hematopoietic Stem Cell Transplant|Bone marrow failure may be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
12053609|NCT00167206|Procedure|Thymic Shielding During Radiation|protecting the thymus during total body radiation (450 cGy administered)
12053610|NCT00167206|Procedure|Total Body Irradiation|Six days before the stem cells are given (day -6), subjects will receive total body irradiation with thymic shielding. Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus.
12053611|NCT00167206|Drug|Cyclophosphamide, Fludarabine|Day -5 through Day -2, subjects will receive a chemotherapy regimen of Fludarabine, Cyclophosphamide via central line
12053612|NCT00167180|Procedure|Donor Lymphocyte Infusion|donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg
12053613|NCT00167180|Drug|Induction Chemotherapy|Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV
12053614|NCT00167167|Procedure|Donor Lymphocyte Infusion|"Certain immune cells in your donor's blood called lymphocytes have been shown to fight cancer after bone marrow transplantation. We plan to transfuse large numbers of donor's lymphocytes in the hope of activating the recipient's immune system to attack cancer."
12053615|NCT00167154|Drug|Risperidone and placebo comparator|Up to 2 mg risperidone or matching placebo daily
12053616|NCT00167141|Drug|injection of hormonal male contraceptive|testosterone injections 4 times
12053617|NCT00167128|Device|hearing aid, Phonak EduLink-FM System|
12053618|NCT00167115|Drug|Alcohol|
12053619|NCT00167102|Drug|Alefacept|Study participants will receive weekly IM administration of placebo or 15 mg of alefacept for 12 weeks, to be followed by a 12-week post-treatment period during which the safety, efficacy, and durability of effect in treatment responders will be assessed on weeks 2, 4, 8 and 12.
12053620|NCT00167089|Behavioral|Treadmill Training|Partian body weight support treadmill training, 30 min/day * 3 days /week
12053621|NCT00167011|Procedure|CT|
12053622|NCT00166946|Procedure|foreskin from healthy adults for organotypic culture|
12053623|NCT00166907|Behavioral|Balance and Exercise|
12053624|NCT00166881|Drug|Docetaxel-Irinotecan|Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
12053625|NCT00166868|Drug|Lactobacillus casei rhamnosus (Lcr35)|
12053626|NCT00166868|Drug|Neomycin|
12053627|NCT00166855|Procedure|dynamic MRI and bone marrow sampling|
12053628|NCT00166842|Drug|sirolimus, cyclosporine, tacrolimus|
12053629|NCT00166829|Drug|sirolimus, tacrolimus, mycophenolate mofetil|
12053630|NCT00166816|Drug|sirolimus, cyclosporine, tacrolimus|
12053631|NCT00166803|Drug|Rosiglitazone|Rosiglitazone , 4 mg daily
12053632|NCT00166790|Drug|chemotherapy agents|
12053633|NCT00166790|Procedure|suction curettage|
12053634|NCT00166777|Procedure|exercise training|
12053635|NCT00166725|Drug|Octreotide LAR|
12053636|NCT00166712|Drug|Tacrolimus (TAC)|Tacrolimus (TAC) will be given standard of care by prescription twice a day (2.0 mg), orally. Doses will be adjusted by serum levels. The dose will be modified to achieve 12 hour trough concentrations of 5-8 ng/mL.
12053731|NCT00165672|Drug|RABEPRAZOLE SODIUM|rabeprazole sodium 5 mg: once daily orally for 4 weeks
12053637|NCT00166712|Drug|Sirolimus|Sirolimus will be given standard of care by prescription, dosed at 5mg daily. The dosage will be adjusted by serum level to achieve 24 hour trough concentrations of 8-12 ng/mL by HPLC assay.
12053638|NCT00166712|Drug|Alemtuzumab|Patients receiving alemtuzumab will be premedicated with 50mg of diphenhydramine hydrochloride, and 650mg of acetaminophen 30-60 minutes to the first Alemtuzumab infusion. The of 30mg will be diluted in 100cc sterile 0.9% normal saline and infused over 2 hours. The infusion line must contain an in-line 0.22-micron filter. Alemtuzumab will be administered on the day of transplant (intraoperatively), and on post-operative day 2. Both doses will be administered while the patient is in the hospital. Alemtuzumab is supplied in single-use clear glass ampoules containing 30mg of alemtuzumab in 3mL of solution.
12053639|NCT00166712|Drug|Mycophenolate mofetil (MMF)|MMF will be given at 1.0-1.5gm, twice daily, orally. The first dose will be given pre-transplant, open label fashion.
12053640|NCT00166699|Procedure|ultrasound|The use of ultrasound to guide the insertion of combined spinal epidural needle
12053641|NCT00166686|Drug|Clonidine|
12053642|NCT00166673|Device|FreeStyle Navigator Continuous Glucose Monitoring System|
12053643|NCT00166660|Behavioral|NIDCAP (Newborn Individualized Developmental Care)|The NIDCAP model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account the infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA.
12053644|NCT00166647|Procedure|Blood Sampling|
12053645|NCT00166634|Procedure|Ambulatory Blood Pressure Monitoring (ABPM)|
12053646|NCT00166621|Drug|Buspirone|
12053647|NCT00166608|Procedure|Blood sampling|
12053648|NCT00166595|Drug|Risperidone|
12053649|NCT00166582|Device|electronic medication monitoring system|
12053650|NCT00166582|Behavioral|parent-adolescent communication and problem-solving skills|
12053651|NCT00166556|Drug|Campath-1H and Tacrolimus|
12053652|NCT00166543|Drug|TAS-108|
12053653|NCT00166530|Drug|ezetimibe (+) simvastatin|Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets
12053654|NCT00166530|Drug|simvastatin|Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets
12053655|NCT00166530|Drug|atorvastatin|20 mg atorvastatin once daily for 12 weeks. Tablets
12053656|NCT00166517|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
12053657|NCT00166517|Biological|Comparator: Placebo|3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
12053658|NCT00166504|Drug|ezetimibe (+) simvastatin|simvastatin/ezetimibe 10/20 mg
12053659|NCT00166504|Drug|atorvastatin|atorvastatin 10 mg
12053660|NCT00166491|Drug|Insulin|
12053661|NCT00166478|Drug|Exisulind Therapy|
12053662|NCT00166465|Drug|ALIMTA plus Oxaliplatin versus Oxaliplatin plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen)|
12053663|NCT00166452|Drug|Lenalidamide|
12053664|NCT00166439|Drug|Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)|"rituximab 375 mg/m2 IV Weekly x 4 1 cycle only
~dexamethasone 40 mg PO/IV Days 2-5 q 21 days 2 cycles
~oxaliplatin 130 mg/m2 IV Day 2 q 21 days 2 cycles
~cytosine arabinoside 2000 mg/m2 x 2 doses IV Days 2-3 q 21 days 2 cycles
~pegfilgrastim 6 mg SQ Day 4 q21 days 2 cycles"
12053665|NCT00166426|Drug|Exisulind|
12053666|NCT00166413|Drug|CC-5013|40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle
12053667|NCT00166400|Drug|metoprolol succinate|Treatment with potent beta-blockade titrated to the maximally tolerated dose.
12053668|NCT00166387|Procedure|Blood draw|A single blood draw.
12053669|NCT00166374|Procedure|balloon kyphoplasty|
12053670|NCT00166361|Device|Memokath 051 Ureteral Stent|The Memokath 051 ureter stent is used for the treatment of malignant or benign ureteric strictures in both men and women. The stent design consists of a tightly-coiled nickel-titanium alloy, with a diameter of 10.5 French (Fr) and a fluted proximal diameter expanding to 22 Fr. The stent is manufactured in multiple lengths which are chosen to position the device across the narrowed area rather than crossing the ureteropelvic or ureterovesical junction. It has a thermal memory system for its predetermined shape; the stent softens at temperatures below 10 degrees Celsius but regains its shape when heated above 55 degrees Celsius.
12053671|NCT00166361|Device|JJ Stent|A JJ stent is a flexible plastic tube that drains urine from the kidney to the bladder and is supposed to stay in place temporarily. There is a coil on each end to keep the stent in place, preventing the stent from migrating down and out from the kidney or up from the bladder into the ureter. The stent can stay in place for few weeks to 3 months or more depending on the indication. If left for more than 6-9 months some stents may get encrusted leading to stone formation around the stent.
12053672|NCT00166348|Behavioral|Cognitive Group Therapy|
12053673|NCT00166322|Procedure|IBZM-SPECT (bolus and constant infusion paradigm)|single IBZM-SPECT assessment at study inclusion
12053674|NCT00166309|Drug|FEIBA and NovoSeven|
12053675|NCT00166296|Drug|Escitalopram|15 mg/day starting 2 weeks before and 12 weeks during interferon therapy
12053676|NCT00166296|Drug|Placebo|Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.
12053677|NCT00166283|Behavioral|memory retraining exercises|Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
12053678|NCT00166283|Behavioral|placebo control memory exercises|Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
12053679|NCT00166270|Device|ExAblate 2000|
12053680|NCT00166257|Device|Percutaneous closure of patent foramen ovale|Percutaneous implantation of an AMPLATZER® PFO Occluder
12053681|NCT00166257|Drug|Medical antitrhombotic treatment|Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d
12053797|NCT00165191|Drug|5-fluorouracil|
12053682|NCT00166244|Drug|Mycophenolate Mofetil|"1 g for adult patients and 300 mg/m2 for paediatric patients. Fixed dose arm: 1 g twice a day (bid) for adults and 600mg/m2 bid for paediatric patients.
~Concentration controlled arm: initial dose will be 1 g bid for adults and 600mg/m2 bid for paediatric patients. Abbreviated AUCs (taken at timepoints: 0, 30min and 120min in fasted patients) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine mycophenolic acid levels in plasma."
12053683|NCT00166218|Device|near-infrared spectroscopy|
12053684|NCT00166205|Device|Swedish Adjustable Gastric Band|Long term implantable device.
12053685|NCT00166192|Procedure|Jessner's solution chemical peel|
12053686|NCT00166192|Procedure|Trichloroacetic acid chemical peel|
12053687|NCT00166166|Drug|Tetraethylammonium (TEA)|5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min
12053688|NCT00166166|Drug|L-NG-monomethyl Arginine (L-NMMA)|5 minute intra-arterial infusion of L-NMMA 8 μmol/min
12053689|NCT00166166|Drug|Bradykinin|Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes.
12053690|NCT00166166|Drug|Sodium nitroprusside|Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes.
12053691|NCT00166166|Drug|Acetylcholine|Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes.
12053692|NCT00166166|Drug|Saline|5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min
12053693|NCT00166166|Drug|Fluconazole|5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min
12053694|NCT00166153|Drug|Mycophenolate Mofetil|
12053695|NCT00166127|Drug|Levosimendan|
12053696|NCT00166114|Drug|Escitalopram|10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
12053697|NCT00166114|Drug|Desipramine|25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
12053698|NCT00166088|Dietary Supplement|Mediterranean Diet|The Mediterranean diet group will receive all meals as a prototypical Mediterranean diet for 4 consecutive weeks prepared by the GCRC metabolic kitchen with dietary instruction. During the second month of the study they will be asked to follow a Mediterranean diet using their own home-cooked meals
12053699|NCT00166088|Dietary Supplement|Mediterranean Dietary Supplement|The subjects randomized to the typical diet + targeted Mediterranean dietary supplement group will not receive dietary counseling. They will be given a one-month supply of specific supplements by the GCRC nutritionists and advised to consume these daily, in addition to their usual diet.
12053700|NCT00166075|Procedure|Computer screen with community resource printout|Patients participated in the screening process via a computer kiosk. Questions regarding IPV and mental health symptoms were asked using validated tools
12053701|NCT00166062|Procedure|Screening patients for IPV|
12053702|NCT00166049|Behavioral|Family Partnership Intervention (FPI)|HF patient and family receive structured patient and family education sessions plus intervention to improve family communication one month after enrollment.Patient and family member received one individual dyadic education/counseling session after baseline data collection, and two group sessions (2-3 months after baseline) focused on developing family approaches to HF self management.Telephone counseling for the dyad and reinforcing mailed newsletters at 5-6 months after baseline.
12053703|NCT00166049|Behavioral|Patient and Family Education|HF Patient and one family member receive structured education sessions one month after enrollment.Two sessions, one indivdual with patient-family member dyad after baseline, and one in a group setting between 2-3 months after baseline. The group session was 2 hours in duration. Telephone counseling for the dyad ast 5-6 months, mailed newsletters at Mailed newsletters at 5-6 months.
12053704|NCT00166049|Behavioral|Usual care with educational material|Usual care with provision of printed educational material, provided once at baseline
12053705|NCT00166036|Drug|Atorvastatin|12 Weeks of Oral Atorvastatin 10 mg therapy.
12053706|NCT00166036|Drug|Pravastatin|12 Weeks of Oral Pravastatin 80 mg therapy.
12053707|NCT00166010|Drug|Nesiritide|Standard dose of nesiritide which is a loading dose of 1 mcg/kg IV over 30 minutes followed by a nesiritide infusion at 0.01mcg/kg/min. All patients will be continually evaluated. At any time the attending physician may add or adjust treatment if deemed clinically indicated.
12053708|NCT00165971|Procedure|BIS monitoring|
12053709|NCT00165958|Procedure|Excisional surgery of epidermal cyst|Traditional extirpation of cyst en toto
12053710|NCT00165958|Procedure|Punch incision of epidermal cyst|removal of cyst first with incisional effort with a punch biopsy tool
12053711|NCT00165919|Other|None. Not a clinical trial. Specimens taken for basic research in laboratory.|
12053712|NCT00165893|Device|Accu-Spina Device/IDD therapy|
12053713|NCT00165893|Procedure|Physical Therapy|
12053714|NCT00165880|Drug|E7070|
12053715|NCT00165867|Drug|E7070|
12053716|NCT00165854|Drug|E7070|
12053717|NCT00165841|Drug|Rabeprazole 20 mg|rabeprazole sodium tablet 20 mg once daily
12053718|NCT00165828|Drug|Zonegran|Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks.
12053719|NCT00165815|Drug|ARICEPT|
12053720|NCT00165802|Drug|E7974|Maximum Tolerated Dose defined as 0.45 mg/m^2 administered on Day 1 only of a 21-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.
12053721|NCT00165789|Drug|E2007|
12053722|NCT00165776|Drug|BOTULINUM TOXIN TYPE B|
12053723|NCT00165763|Drug|donepezil hydrochloride (Aricept)|5 mg donepezil HCl given once a day and increased to 10 mg per day if side effects, when present, are tolerated.
12053724|NCT00165750|Drug|DONEPEZIL HYDROCHLORIDE|One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
12053725|NCT00165737|Drug|Donepezil Hydrochloride|
12053726|NCT00165724|Drug|Donepezil Hydrochloride|
12053727|NCT00165711|Drug|Mecobalamin|
12053728|NCT00165698|Drug|menatetranone|15 mg three times a day orally for 12 months
12053729|NCT00165698|Drug|alfacalcidol|0.25 μg twice a day orally for 12 months
12053730|NCT00165685|Drug|Sibutramine Hydrochloride Monohydrate|
12054012|NCT00163202|Drug|Atorvastatin|
12053732|NCT00165672|Drug|RABEPRAZOLE SODIUM|rabeprazole sodium 10 mg: once daily orally for 4 weeks
12053733|NCT00165659|Drug|DONEPEZIL HYDROCHLORIDE|
12053734|NCT00165646|Drug|E3810|E3810 5mg: once daily orally for 4 weeks
12053735|NCT00165646|Drug|E3810|E3810 10mg: once daily orally for 4 weeks
12053736|NCT00165646|Drug|Placebo|Placebo: once daily orally for 4 weeks
12053737|NCT00165633|Drug|Menatetrenone|45 mg capsule, orally, three times a day, after meals.
12053738|NCT00165633|Drug|Menatetrenone|90 mg capsule, orally, three times a day, after meals.
12053739|NCT00165633|Drug|Placebo|Placebo capsule, orally, three times a day, after meals.
12053740|NCT00165620|Drug|Iomeprole|
12053741|NCT00165607|Drug|MENATETRANONE|
12053742|NCT00165594|Drug|E7070|
12053743|NCT00165581|Device|High Dose Intracavitary Brachytherapy|
12053744|NCT00165568|Drug|Bevacizumab|
12053745|NCT00165555|Drug|Cisplatin|Given as a heated one-hour lavage to the hemithorax after surgery.
12053746|NCT00165555|Drug|Sodium Thiosulfate|Given intravenously over 6 hours after the cisplatin lavage.
12053747|NCT00165542|Other|A PROTEIN level|
12053748|NCT00165516|Drug|Cisplatin|Heated and given as an one-hour lavage of the chest and abdomen during surgery
12053749|NCT00165516|Drug|Sodium Thiosulfate|After the one-hour lavage, sodium thiosulfate is given intravenously
12053750|NCT00165503|Drug|Cisplatin|
12053751|NCT00165503|Drug|Sodium Thiosulfate|
12053752|NCT00165503|Drug|ALIMTA|
12053753|NCT00165490|Drug|Cetuximab|Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.
12053754|NCT00165490|Drug|Cisplatin|Given once per week on weeks 1, 2, 4,and 5.
12053755|NCT00165490|Drug|Irinotecan|Given once per week on weeks 1, 2, 4,and 5.
12053756|NCT00165490|Device|Radiation therapy|Once daily for 28 treatments (5 1/2 weeks)
12053757|NCT00165490|Procedure|Surgery|Surgery performed 4-8 weeks after chemoradiation therapy.
12053758|NCT00165477|Drug|lenalidomide|Given orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects
12053759|NCT00165477|Radiation|Radiation|Starting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks
12053760|NCT00165464|Drug|Taxotere|Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
12053761|NCT00165464|Drug|Cisplatin|Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
12053762|NCT00165464|Drug|Irinotecan|Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
12053763|NCT00165451|Drug|Thalidomide|Oral administration once daily at night starting at 3mg/Kg for 6 months.
12053764|NCT00165451|Drug|Celecoxib|Oral administration twice daily starting at 100mg/dose for 6 months.
12053765|NCT00165451|Drug|Etoposide|Oral administration once daily at night starting at 50mg/m2 3 weeks on and 3 weeks off for 6 months.
12053766|NCT00165451|Drug|Cyclophosphamide|Oral administration once daily at night starting at 3.5mg/m2 3 weeks on and 3 weeks off for 6 months.
12053767|NCT00165438|Procedure|Pulmonary Function Tests|Tests include; total lung capacity, vital capacity, functional residual capacity, forced vital capacity, forced expiratory volume in 1 second, carbon monoxide diffusing capacity, pulse oximetry before and after a 6 minute walk and Pulmonary Status and Dyspnea Questionnaire
12053768|NCT00165438|Procedure|CAT Scan|Obtained at different time points during the study depending upon standard of care chemotherapy treatment
12053769|NCT00165425|Procedure|Echo/Stress Echo|Participants will under resting echocardiogram and stress echocardiogram (echo and stress echo) and the results will be interpreted by a cardiologist
12053770|NCT00165412|Procedure|breast MRI|Repeated once a year for three years
12053771|NCT00165412|Procedure|Mammogram|Repeated once a year for three years
12053772|NCT00165399|Drug|Docetaxel|Given intravenously on day 2 of four three-week cycles
12053773|NCT00165399|Drug|Estramustine|Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)
12053774|NCT00165399|Drug|Casodex|Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months
12053775|NCT00165399|Drug|Zoladex|Started one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections.
12053776|NCT00165386|Procedure|Magnetic Resonance Imaging|
12053777|NCT00165386|Procedure|Bone Marrow Biopsy|
12053778|NCT00165373|Drug|rhEndostatin|Given by continuous infustion for 28 days (one of two dosing groups) for a total of 2 cycles. Treatment can be extended if tolerated well.
12053779|NCT00165360|Drug|Temozolomide|Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half
12053780|NCT00165347|Drug|PTK787/ZK222584|
12053781|NCT00165334|Drug|Cetuximab|
12053782|NCT00165334|Drug|Vinorelbine (Navelbine)|
12053783|NCT00165308|Drug|Tamoxifen|Given orally, daily for one year.
12053784|NCT00165295|Drug|Sildenafil citrate (Viagra)|
12053785|NCT00165282|Behavioral|Mindfulness training|Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d
12053786|NCT00165282|Behavioral|Nurse education|Meets with oncology nurse to have questions answered about medical treatments and side effects
12053787|NCT00165269|Procedure|Mantle irradiation|Limited to above the diaphragm
12053788|NCT00165256|Other|Observation|Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue
12053789|NCT00165243|Procedure|Tangential radiation|Radiation given over 6 1/2 weeks
12053790|NCT00165230|Drug|Thalidomide|
12053791|NCT00165230|Drug|Temodar|
12053792|NCT00165217|Drug|Capecitabine|
12053793|NCT00165217|Drug|Thalidomide|
12053794|NCT00165204|Drug|Tibolone|
12053795|NCT00165191|Drug|Doxorubicin|
12053796|NCT00165191|Drug|Cisplatin|
12053798|NCT00165178|Drug|prednisone|Induction Phase: Given orally or intravenously Days 0-28 Intensification Phase: Given orally Days 1-5 of each cycle Continuation Phase: Given orally Days 1-5 of each cycle
12053799|NCT00165178|Drug|dexamethasone|Intensification Phase: Given orally days 1-5 of each cycle Continuation Phase: Given orally days 1-5 pf each cycle
12053800|NCT00165178|Drug|doxorubicin|Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle
12053801|NCT00165178|Drug|E. coli asparaginase|Intensification Phase: In the muscle weekly. Dose will vary
12053802|NCT00165178|Drug|vincristine|Induction: Intravenously on days 0, 7, 14, 21 MLL Intensification Phase: Intravenously on Days 1, 8, 15, 22 CNS Therapy: Intravenously on Day 1 Intensification Phase: Intravenously on day 1 of each cycle Continuation Phase: Intravenously on Day 1 of each cycle
12053803|NCT00165178|Drug|methotrexate|Induction: Intravenously on Day 2 MLL Intensification: Intravenously on Days 1, 8 Intensification: (when doxorubicin completed) Intravenously or into the muscle weekly Continuation: Intravenously or into the muscle weekly
12053804|NCT00165178|Drug|Leucovorin|Induction Phase: Intravenously or orally begins 36 hours after methotrexate MLL Intensification: Intravenously or orally begins 36 hours after methotrexate
12053805|NCT00165178|Drug|Asparaginase|Induction: Into the muscle on Day 4 MLL Intensification: Into the muscle on Days 16, 23
12053806|NCT00165178|Drug|cytarabine|Induction: Intrathecal on Days 0, 14, 28 MLL Intensification: Intravenously on Days 15, 16, 22, 23
12053807|NCT00165178|Drug|Methotrexate/Hydrocortisone|Induction: Intrathecal on Days 14, 28 MLL Intensification: Intrathecal on Days 2,9
12053808|NCT00165152|Procedure|Genetic Counseling|Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
12053809|NCT00165152|Procedure|Informed Consent Counseling|Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
12053810|NCT00165139|Drug|Vincristine|Described under detailed description
12053811|NCT00165139|Drug|Cyclophosphamide|Described under detailed description
12053812|NCT00165139|Drug|Adriamycin|Described under detailed description
12053813|NCT00165139|Drug|Etoposide (VP-16)|Described under detailed description
12053814|NCT00165139|Drug|Cisplatin|Described under detailed description
12053815|NCT00165139|Drug|Carboplatin|Described under detailed description
12053816|NCT00165139|Drug|Melphalan|Described under detailed description
12053817|NCT00165139|Drug|Ifosfamide|Described under detailed description
12053818|NCT00165139|Drug|G-CSF (granulocyte-colony stimulating factor)|Described under detailed description
12053819|NCT00165139|Drug|Mesna|Described under detailed description
12053820|NCT00165126|Procedure|Radiation therapy|Given as standard therapy
12053821|NCT00165100|Procedure|Dynamic Area Telethermometry (DAT)|
12053822|NCT00165087|Drug|asparaginase (E. Coli)|
12053823|NCT00165087|Drug|asparaginase (Erwina)|
12053824|NCT00165087|Drug|dexrazoxane|
12053825|NCT00165087|Drug|doxorubicin|
12053826|NCT00165087|Procedure|cranial radiation (once daily fractionation)|
12053827|NCT00165087|Procedure|cranial radiation (twice-daily fractionation)|
12053828|NCT00165087|Procedure|Intrathecal chemotherapy without radiation|
12053829|NCT00165074|Drug|Infasurf (drug)|Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses
12053830|NCT00165061|Procedure|Esophagectomy|
12053831|NCT00165061|Procedure|Chemoradiation|
12053832|NCT00165048|Drug|Vioxx (Rofecoxib)|
12053833|NCT00165035|Device|CoStar Paclitaxel Drug Eluting Coronary Stent System|Drug eluting stent
12053834|NCT00165035|Device|TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent|Drug eluting stent
12053835|NCT00165009|Device|Resolution clip (endo-clipping device)|Resolution clip (endo-clipping device)
12053836|NCT00164996|Procedure|Local pharyngeal anaesthesia|
12053837|NCT00164996|Device|Ultrathin endoscope|
12053838|NCT00164970|Dietary Supplement|Vitamin B12|
12053839|NCT00164970|Dietary Supplement|folate|
12053840|NCT00164957|Device|continuous pump feeding|
12053841|NCT00164957|Other|intermittent bolus feeding|
12053842|NCT00164944|Procedure|Colonoscopy|To determine the adenomas during colonoscopy
12053843|NCT00164944|Procedure|Colonoscopy|To determine the adenomas during colonoscopy
12053844|NCT00164931|Drug|Intravenous omeprazole infusion|
12053845|NCT00164931|Procedure|Scheduled second endoscopy|
12053846|NCT00164918|Device|nasogastric tube|
12053847|NCT00164905|Device|Doppler ultrasound probe|Applying to ulcer base to assess the blood flow underneath the ulcer
12053848|NCT00164892|Drug|Oral Vioxx (Rofecoxib)|
12053849|NCT00164879|Procedure|Endoscopic stenting followed by elective laparoscopic resection|
12053850|NCT00164866|Drug|Omeprazole|
12053851|NCT00164853|Procedure|endoscopic balloon dilatation|Refer to description under arms
12053852|NCT00164853|Procedure|Standard sphincterotomy|Refer to under arms
12053853|NCT00164840|Drug|Esomeprazole|
12053854|NCT00164827|Device|Endoscopic placement of Capsule endoscope adjacent to the peptic ulcer|
12053855|NCT00164801|Drug|Baclofen, Diltiazem|
12053856|NCT00164788|Drug|Intravenous bolus injection of esomeprazole|80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
12053857|NCT00164788|Drug|Oral esomeprazole|40mg every 12 hours for 24 hours
12053858|NCT00164775|Drug|Imipramine|25mg nocte for first 2 weeks then 50 mg nocte for 10 weeks
12053859|NCT00164775|Drug|Placebo|One tab nocte for first 2 weeks then 2 tabs for 10 weeks
12053860|NCT00164749|Drug|Placebo and ginkgo extract|Placebo once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
12054087|NCT00162474|Drug|Phenytoin|
12053861|NCT00164749|Drug|Curcumin and ginkgo extract|1 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
12053862|NCT00164749|Drug|Curcumin and ginkgo extract|4 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
12053863|NCT00164736|Drug|Maternal zidovudine/lamivudine/lopinavir-ritonavir|Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.
12053864|NCT00164736|Drug|Infant nevirapine|"Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg.
~To 28 weeks while breastfeeding."
12053865|NCT00164736|Dietary Supplement|Maternal protein and calorie supplement|High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
12053866|NCT00164723|Procedure|Capsule endoscopy|Capsule endoscopy and colonoscopy
12053867|NCT00164710|Drug|sulfadoxine-pyrimethamine|
12053868|NCT00164710|Drug|amodiaquine plus sulfadoxine-pyrimethamine|
12053869|NCT00164710|Drug|amodiaquine plus artesunate|
12053870|NCT00164710|Drug|chlorproguanil-dapsone plus artesunate|
12053871|NCT00164710|Drug|lumefantrine-artemether|
12053872|NCT00164697|Behavioral|Parenting group|Weekly and periodic (10 weeks blocks with 6 week break) parenting group meetings (2.5-3 hr), periodic one-on-one meetings (2 hr), visits to community resources (2-3 hr per event). Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events.
12053873|NCT00164684|Behavioral|Father Friendly Initiative|
12053874|NCT00164671|Behavioral|POWER|
12053875|NCT00164658|Behavioral|Familial risk assessment and personalized prevention messages|
12053876|NCT00164645|Behavioral|Problem Solving intervention|
12053877|NCT00164632|Behavioral|counselling, exercise, referrals (behavior)|
12053878|NCT00164619|Behavioral|VOICES/VOCES|45-minute intervention for small groups of African American and Hispanic heterosexual men and women. Group members are same gender and race/ethnicity. View culturally-specific condom promotion video. Facilitated group discussion to build skills in condom use and condom negotiation. Education on condom varieties to overcome participants' personal barriers to condoms use. Distribution of 3 specialty condoms of participant's choice (i.e., different sizes, textures, thicknesses, lubrication, material). [see Brief Summary above]
12053879|NCT00164619|Biological|Standard STD clinic services|Individual physical exam, STD/HIV tests, treatment as indicated
12053880|NCT00164606|Behavioral|Positive Parenting Program (Triple-P)|
12053881|NCT00164593|Behavioral|Youth Empowerment Solutions for Peaceful Communities|YES is a multi-faceted program that (1) engages 7th and 8th graders in a youth development program, (2) enhances neighborhood organizations' ability to include youth in their activities, and (3) connects the youth participants and adults in neighborhood organizations (e.g., crime watches, block groups, neighborhood associations) to carry out neighborhood improvement activities (e.g., community gardens, parks cleanup).
12053882|NCT00164580|Behavioral|Community-Level Intervention|
12053883|NCT00164567|Behavioral|Onsite IPV specialist|
12053884|NCT00164567|Behavioral|Empowerment focused intervention|
12053885|NCT00164554|Behavioral|Parent-child Interaction Therapy (PCIT)|
12053886|NCT00164541|Behavioral|Arts Based Program|
12053887|NCT00164541|Behavioral|Curriculum|
12053888|NCT00164528|Behavioral|Positive Behavior Support|
12053889|NCT00164515|Behavioral|Personalized exercise programme (PEP)|Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago
12053890|NCT00164502|Behavioral|Community-based eight session group self-management program|
12053891|NCT00164489|Behavioral|Weight control and physical activity promotion|
12053892|NCT00164476|Behavioral|Preventive Services Prevention Kit|
12053893|NCT00164476|Behavioral|peer mentors (control group)|
12053894|NCT00164463|Drug|Moxifloxacin|400 mg po qd 5/7 days per week
12053895|NCT00164463|Drug|Isoniazid|isoniazid 300 mg po qd 5/7 days per week
12053896|NCT00164450|Drug|Rifapentine + isoniazid once weekly for 3 months|
12053897|NCT00164437|Behavioral|educational CD-ROM|
12053898|NCT00164424|Drug|Acyclovir|
12053899|NCT00164411|Biological|Tetanus-diphtheria toxoids (Td)|
12053900|NCT00164411|Biological|7-valent pneumococcal conjugate vaccine|
12053901|NCT00164411|Biological|23-valent polysaccharide vaccine|
12053902|NCT00164398|Behavioral|HIP: HIV Intervention for Providers|
12053903|NCT00164385|Behavioral|Adolescent Impact|
12053904|NCT00164372|Behavioral|Peer Education Intervention|
12053905|NCT00164359|Drug|Amodiaquine plus artesunate|
12053906|NCT00164359|Drug|chlorproguanil-dapsone plus artesunate|
12053907|NCT00164346|Behavioral|neurocognitive habilitation|
12053908|NCT00164333|Behavioral|TAP: Treatment Advocacy Program|
12053909|NCT00164320|Behavioral|TEAM|
12053910|NCT00164307|Behavioral|Parent assisted social skills training|
12053911|NCT00164294|Behavioral|Brief intervention|
12053912|NCT00164281|Drug|Isoniazid|Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
12053913|NCT00164268|Behavioral|Ke Ala Lokahi (Native Hawaiian cultural intervention)|
12053914|NCT00164255|Drug|sulfadoxine/pyrimethamine|
12053915|NCT00164255|Drug|sulfadoxine/pyrimethamine plus artesunate|
12053916|NCT00164242|Drug|Galantamine|
12053917|NCT00164229|Behavioral|math|
12053918|NCT00164229|Behavioral|behavior regulation|
12053919|NCT00164216|Drug|mefloquine plus artesunate|
12053920|NCT00164203|Behavioral|Cognitive Behavioral Therapy|12-session, weekly, school-based protocol based on cognitive restructuring, tailored to children Grades 3 to 6; comparison with activity control condition of equal duration.
12053921|NCT00164203|Behavioral|School-based CBT|12 sessions, weekly
12053922|NCT00164203|Behavioral|activity control condition|weekly games & activities x 12 weeks
12053923|NCT00164190|Procedure|Routine Early Percutaneous Coronary Intervention after Thrombolysis|early or delayed PCI
12053924|NCT00164177|Drug|HalfLytely|
12053925|NCT00164164|Drug|HalfLytely|
12053926|NCT00164164|Drug|NuLytely|
12053927|NCT00164151|Drug|HalfLytely|
12053928|NCT00164151|Drug|Visicol|
12053929|NCT00164138|Procedure|Pelvic floor training group|pelvic floor training, electrotherapy, bladder retraining.
12053930|NCT00164125|Drug|polyethyleneglycol3350|
12053931|NCT00164112|Drug|Cooperstown 5+1 alone|
12053932|NCT00164112|Drug|Azithromycin plus Cooperstown 5+1|
12053933|NCT00164112|Drug|Telithromycin plus Cooperstown 5+1|
12053934|NCT00164112|Drug|Levofloxacin plus Cooperstown 5+1|
12053935|NCT00164099|Drug|Synbiotic 2000|See protocol - 4 bacteria, 4 fiber mixture
12053936|NCT00164086|Drug|atorvastatin|
12053937|NCT00164073|Procedure|Liver biopsy|
12053938|NCT00164047|Drug|Nitrous Oxide|
12053939|NCT00164034|Device|Real time computer prompted trauma algorithms|
12053940|NCT00164021|Procedure|Physiotherapy, exercise, percutaneous gastrostomy feeds|
12053941|NCT00164021|Drug|Anti-reflux pharmacotherapy|
12053942|NCT00164008|Drug|zoledronic acid vs pamidronate|
12053943|NCT00163995|Drug|urotensin II|
12053944|NCT00163982|Drug|Norfloxacin|
12053945|NCT00163969|Drug|ketamine|
12053946|NCT00163943|Behavioral|Dietary weight loss +/- aerobic exercise|
12053947|NCT00163917|Device|Virtual reality relaxation|
12053948|NCT00163904|Behavioral|High mono-unsaturated fat/low carbohydrate diet|
12053949|NCT00163904|Behavioral|High carbohydrate/low fat diet|
12053950|NCT00163891|Behavioral|Chest physiotherapy|
12053951|NCT00163878|Procedure|Sensory Stimulation|
12053952|NCT00163878|Device|Sesnory Modality Assessment and Rehabilitation Technique|
12053953|NCT00163852|Drug|Normal saline IV, salt tablets|
12053954|NCT00163839|Behavioral|Dietary Therapy|
12053955|NCT00163813|Procedure|Early jejunal feeding (using frictional NJ tube)|
12053956|NCT00163813|Procedure|Standard feeding (using nasogastric [NG] tube)|
12053957|NCT00163787|Behavioral|outcome measures and self report|
12053958|NCT00163774|Device|Brain oxygenation and microdialysis catheters|
12053959|NCT00163761|Drug|gemcitabine, vinorelbine, ifosfamide, filgastrim|Drug
12053960|NCT00163761|Drug|gemcitabine, vinorelbine, filgastrim|Drug
12053961|NCT00163748|Drug|gemcitabine, vinorelbine|
12053962|NCT00163735|Drug|Administration of wine fined with potential food allergens|
12053963|NCT00163722|Other|Culture and histology|
12053964|NCT00163722|Other|Aspergillus galactomannan and PCR|
12053965|NCT00163709|Procedure|BNP test|
12053966|NCT00163683|Behavioral|Dietary Therapy|
12053967|NCT00163657|Drug|Daclizumub|anti-rejection drug
12053968|NCT00163657|Drug|Tacrolimus|anti rejection drug
12053969|NCT00163657|Drug|Cyclosporine|anti rejection drug
12053970|NCT00163657|Drug|MMF|anti rejection drug
12053971|NCT00163644|Procedure|aereobic plus resisted exercise|
12053972|NCT00163644|Procedure|aerobic plus active exercise|
12053973|NCT00163644|Other|No formal exercise plus phone calls|
12053974|NCT00163618|Biological|Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|
12053975|NCT00163605|Device|Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)|
12053976|NCT00163592|Drug|Tissucol®|
12053977|NCT00163592|Procedure|Control: Conventional treatment, i.e. compression with swabs|
12053978|NCT00163579|Drug|Bryophyllum|
12053979|NCT00163579|Other|Placebo|
12053980|NCT00163566|Drug|Dihydrotestosterone (0.7%) in hydroalcoholic gel|transdermal gel, 0.7% DHT, 0.35 mg/day or 0.70 mg/day total daily dose (or placebo gel), applied twice per day
12053981|NCT00163553|Drug|Pethidine|
12053982|NCT00163553|Drug|Placebo|
12053983|NCT00163540|Biological|Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|
12053984|NCT00163527|Drug|Roflumilast|
12053985|NCT00163514|Drug|Ciclesonide|
12053986|NCT00163501|Drug|Ciclesonide|
12053987|NCT00163488|Drug|Ciclesonide|
12053988|NCT00163475|Drug|Roflumilast|
12053989|NCT00163462|Drug|Ciclesonide|
12053990|NCT00163449|Drug|Ciclesonide|Efficacy and Safety of Ciclesonide
12053991|NCT00163449|Drug|Placebo|Placebo
12053992|NCT00163436|Drug|Ciclesonide|
12053993|NCT00163423|Drug|Ciclesonide|
12053994|NCT00163410|Drug|Ciclesonide|
12053995|NCT00163397|Drug|Ciclesonide|
12053996|NCT00163384|Drug|Ciclesonide|
12053997|NCT00163371|Drug|Ciclesonide|
12053998|NCT00163358|Drug|Ciclesonide|
12053999|NCT00163345|Drug|Ciclesonide|
12054000|NCT00163332|Drug|Ciclesonide|
12054001|NCT00163319|Drug|Ciclesonide|
12054002|NCT00163306|Drug|Pantoprazole|
12054003|NCT00163293|Drug|Ciclesonide|Ciclesonide metered-dose inhaler
12054004|NCT00163293|Drug|Placebo|Ciclesonide placebo-matching metered-dose inhaler
12054005|NCT00163280|Drug|ATL-104|Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.
12054006|NCT00163267|Drug|clopidogrel|Best endovascular treatment either with one or the other drug arm should be investigated
12054007|NCT00163254|Drug|abciximab|
12054008|NCT00163254|Device|stent and drug eluting stent|
12054009|NCT00163241|Drug|celecoxib|
12054010|NCT00163215|Drug|Somatropin|Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years
12054011|NCT00163202|Procedure|Blood samples|
12054013|NCT00163189|Drug|Somatropin|Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
12054014|NCT00163163|Procedure|Echographic measurements|
12054015|NCT00163163|Procedure|Blood samples|
12054016|NCT00163150|Drug|Atorvastatin|
12054017|NCT00163137|Drug|lasofoxifene|lasofoxifene 0.25mg
12054018|NCT00163137|Drug|raloxifene|raloxifene 60 mg/day
12054019|NCT00163137|Drug|Placebo|0 mg/day
12054020|NCT00163124|Procedure|spinal manipulation & patient education/nutrition|
12054021|NCT00163111|Drug|VFENDÂ® I.V., Oral|
12054022|NCT00163111|Drug|Conventional amphotericin B|
12054023|NCT00163111|Drug|Diflucan IV, oral|
12054024|NCT00163098|Drug|UK-369,003|
12054025|NCT00163085|Drug|NR2B NMDA Antagonist CP-101,606 (traxoprodil)|
12054026|NCT00163072|Drug|transdermal Megace|oral vs transdermal levels
12054027|NCT00163059|Drug|NMDA Antagonist, CP-101,606 (traxoprodil)|
12054028|NCT00163046|Drug|Gabapentin|Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
12054029|NCT00163046|Drug|Placebo|Matched placebo 30 minutes prior to bedtime for 28 days
12054030|NCT00163033|Drug|estetrol|
12054031|NCT00163020|Drug|17-alpha-hydroxyprogesterone caproate injectable|250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first.
12054032|NCT00163020|Drug|Placebo|Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.
12054033|NCT00163007|Procedure|Nutritional support|
12054034|NCT00162994|Procedure|adenoidectomy and tymapanostomy|
12054035|NCT00162981|Drug|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
12054036|NCT00162981|Drug|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
12054037|NCT00162968|Drug|escitalopram|
12054038|NCT00162955|Drug|Valsartan|Patients allocated into ARB administration group take Valsartan (80mg/day) from the day of the start of 1st CHOP until the completion of all the evaluations.
12054039|NCT00162942|Device|Adacolumn|"Ten apheresis sessions:
~One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9)."
12054040|NCT00162942|Device|Sham|Sham, ten apheresis sessions within 9 weeks
12054041|NCT00162929|Biological|AdHer-2/neu transduced dendritic cells|Group 1 1 ×10'7 expanded cells (2.5 ×106 DCs per injection site) Group 2 5 ×10'7 expanded cells (1.25 ×107 DCs per injection site) Group 3 1 ×10'8 expanded cells (2.5 ×107 DCs per injection site)
12054042|NCT00162916|Drug|citalopram|20mg or 40mg, once daily, for 40 weeks
12054043|NCT00162916|Drug|Placebo|Cornstarch
12054044|NCT00162890|Behavioral|Therapeutic exercise|
12054045|NCT00162877|Drug|Rabeprazole vs. Esomeprazole|
12054046|NCT00162864|Drug|montelukast sodium|
12054047|NCT00162851|Drug|alemtuzumab|
12054048|NCT00162812|Drug|Epirubicin|100 mg/m² every three weeks (4 cycles) or every two weeks (6 cycles)
12054049|NCT00162799|Drug|Triflusal (DCI)|
12054050|NCT00162786|Drug|Rupatadine|
12054051|NCT00162786|Drug|Hydroxyzine|
12054052|NCT00162786|Drug|Placebo|
12054053|NCT00162773|Drug|omalizumab|150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.
12054054|NCT00162773|Other|Placebo|150-375 milligrams depending on body weight and serum IgE.
12054055|NCT00162760|Drug|Thalidomide|
12054056|NCT00162747|Drug|Aquaphor|
12054057|NCT00162747|Drug|Sunflower Seed Oil|
12054058|NCT00162734|Drug|Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks|
12054059|NCT00162721|Drug|doxorubicin, ifosfamide, cisplatin|
12054060|NCT00162708|Procedure|Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)|
12054061|NCT00162708|Procedure|Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)|
12054062|NCT00162708|Drug|CDDP, 5 Fu|
12054063|NCT00162695|Drug|Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide|
12054064|NCT00162682|Procedure|Antiretroviral Drug Combination Switching Criteria|Antiretroviral treatment will use the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.
12054065|NCT00162682|Procedure|Antiretroviral Drug Combination Switching Criteria|Antiretroviral treatment is monitored using a CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.
12054066|NCT00162669|Drug|bevacizumab|
12054067|NCT00162656|Drug|half cyclophosphamide|
12054068|NCT00162656|Drug|without COPADM3|
12054069|NCT00162656|Drug|mini CYVE, without 3 maintenance courses|
12054070|NCT00162656|Drug|LMB B|
12054071|NCT00162656|Drug|LMB C|
12054072|NCT00162643|Drug|zidovudine+lamivudine+lopinavir/ritonavir|
12054073|NCT00162643|Drug|zidovudine + lamivudine + efavirenz|
12054074|NCT00162630|Procedure|Fascia Iliaca Compartment Blockade|
12054075|NCT00162617|Drug|Red blood cell transfusion|
12054076|NCT00162604|Drug|Cefuroxime|
12054077|NCT00162591|Drug|remifentanyl|
12054078|NCT00162565|Drug|beta-blocker treatment|beta-blocker treatment
12054079|NCT00162552|Drug|pentoxifylline|Patients with severe cirrhosis treated with Pentoxifylline
12054080|NCT00162552|Drug|PLACEBO|Patients with severe cirrhosis treated with a placebo
12054081|NCT00162539|Other|echography|Correlation of neonatal thyroid volume with maternal iodine deficiency
12054082|NCT00162526|Drug|Tocopherol|
12054083|NCT00162513|Biological|Allogeneic tumor cell vaccine|
12054084|NCT00162500|Biological|Peptide Vaccine (MUC-1)|
12054085|NCT00162487|Drug|Albuterol (1,200 μg) through metered-dose inhaler|
12054086|NCT00162474|Drug|Warfarin|
12054088|NCT00162461|Drug|Phenytoin single dose (300 mg)|
12054089|NCT00162448|Drug|BMS-394136|Oral Solution, Oral, 100 mg, Single dose, 1 day.
12054090|NCT00162448|Drug|Placebo|Oral Solution, Oral, 0 mg, Single dose, 1 day.
12054091|NCT00162435|Drug|Warfarin|
12054092|NCT00162422|Drug|albuterol|
12054093|NCT00162409|Drug|Folic acid|
12054094|NCT00162396|Drug|Albuterol|
12054095|NCT00162383|Drug|Debrisoquine|
12054096|NCT00162383|Drug|Mephenytoin|
12054097|NCT00162383|Drug|Dapsone|
12054098|NCT00162383|Drug|Caffeine|
12054099|NCT00162370|Drug|Perflutren Lipid Microsphere Injectable Suspension|Activated DEFINITY 10ug/kg by bolus injection
12054100|NCT00162357|Drug|Technetium Tc99m Sestamibi|
12054101|NCT00162344|Drug|Technetium Tc99m Sestamibi|
12054102|NCT00162331|Drug|Technetium Tc99m Sestamibi|
12054103|NCT00162318|Drug|Cetuximab + Gefitinib|IV solution + tablet, IV + oral, ERB (100 mg/m2, 200 mg/m2 + 250 mg/m2 IV) +GEF 250 mg tablet, ERB weekly/ GEF once daily, Until disease progression.
12054104|NCT00162305|Drug|BMS-512148|Capsules, Oral, 100 mg, Once daily, 14 days.
12054105|NCT00162305|Drug|BMS-512148|Capsules, Oral, 25 mg, Once daily, 14 days.
12054106|NCT00162305|Drug|BMS-512148|Capsules, Oral, 5 mg, Once daily, 14 days.
12054107|NCT00162305|Drug|Placebo|Capsules, Oral, 0 mg, Once daily, 14 days.
12054108|NCT00162292|Drug|BMS-582949 and Methotrexate|
12054109|NCT00162279|Drug|Abatacept|
12054110|NCT00162266|Drug|Abatacept (BMS-188667)|IV, 10 mg/Kg, monthly, for the duration of the trial
12054111|NCT00162266|Drug|Abatacept (BMS-188667)|Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
12054112|NCT00162266|Drug|Abatacept (BMS-188667)|Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
12054113|NCT00162266|Drug|Placebo|Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
12054114|NCT00162253|Drug|BMS 587101|
12054115|NCT00162240|Drug|Muraglitazar|
12054116|NCT00162227|Drug|Efavirenz|Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
12054117|NCT00162214|Drug|Dasatinib + Ketoconazole|Tablets, Oral, Segment 1: escalating single dose of dasatinib starting at 140 mg q24 hours on Day 1-8; single dose of ketoconazole 200 mg q12 hours on Days 3-8; Segment 2: single daily oral doses of dasatinib, once daily, until disease progression or unacceptable toxicity.
12054118|NCT00162201|Drug|Abatacept|Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.
12054119|NCT00162188|Drug|Efavirenz|Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
12054120|NCT00162175|Drug|Muraglitazar|
12054121|NCT00162149|Drug|Nevirapine|Tablets, Oral, 200 mg, Twice daily, 3 days.
12054122|NCT00162149|Drug|Nevirapine + Atazanavir/Ritonavir|Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
12054123|NCT00162149|Drug|Nevirapine + Atazanavir/Ritonavir|Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
12054124|NCT00162149|Drug|Atazanavir + Ritonavir|Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
12054125|NCT00162136|Drug|Ixabepilone|Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
12054126|NCT00162123|Drug|Ipilimumab|Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
12054127|NCT00162110|Drug|cetuximab|mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
12054128|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
12054129|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
12054130|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
12054131|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
12054132|NCT00162084|Drug|apadenoson|
12054133|NCT00162071|Drug|apadenoson|
12054134|NCT00162058|Drug|Peflutren Lipid Microsphere Injectable Suspension|
12054135|NCT00162045|Drug|Technetium Tc99m Sestamibi|Rest and/or stress SPECT imaging study
12054136|NCT00162032|Drug|Sestamibi|Sestamibi
12054137|NCT00162019|Drug|Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)|
12054138|NCT00162006|Drug|Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution|
12054139|NCT00161993|Drug|Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution|
12054140|NCT00161993|Drug|Gammagard S/D (Solvent/Detergent)|
12054141|NCT00161980|Drug|Fibrin Sealant VH S/D|
12054142|NCT00161980|Procedure|Surgical intervention alone without Fibrin Sealant VH S/D application|
12054143|NCT00161967|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age.
12054144|NCT00161954|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
12054145|NCT00161928|Biological|Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)|
12054146|NCT00161915|Drug|Fibrin Sealant|
12054147|NCT00161902|Drug|Fibrin Sealant Vapor-Heated Solvent/Detergent-treated|
12054148|NCT00161889|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
12054149|NCT00161876|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
12054150|NCT00161863|Biological|FSME-IMMUN NEW 0.25 ml|
12054151|NCT00161850|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
12054152|NCT00161837|Biological|Vero Cell-derived Influenza Vaccine|
12054153|NCT00161837|Biological|Egg-derived Influenza Vaccine|
12054154|NCT00161824|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
12054155|NCT00161811|Biological|Vero Cell-derived Influenza Vaccine|
12054424|NCT00159419|Drug|Pamidronate|
12054156|NCT00161811|Biological|Egg cell-derived Influenza Vaccine|
12054157|NCT00161798|Biological|Tick-borne encephalitis vaccine|
12054158|NCT00161785|Biological|FSME-IMMUN 0.5ml|
12054159|NCT00161772|Biological|Tick-borne Encephalitis Vaccine|
12054160|NCT00161759|Drug|Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin|
12054161|NCT00161746|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
12054162|NCT00161733|Drug|Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)|
12054163|NCT00161733|Drug|TISSEEL VH fibrin sealant|
12054164|NCT00161720|Drug|Protein C Concentrate (Human) Vapor Heated|
12054165|NCT00161707|Drug|Aerosolized, Recombinant Alpha 1-Antitrypsin|
12054166|NCT00161694|Dietary Supplement|sucrose solution|
12054167|NCT00161681|Drug|Levonorgestrel/Ethinyl Estradiol|
12054168|NCT00161668|Drug|Mylotarg|
12054169|NCT00161655|Drug|Etanercept|
12054170|NCT00161655|Drug|Methotrexate|
12054171|NCT00161642|Drug|CMD-193|
12054172|NCT00161629|Drug|rhBMP-2/CPM|
12054173|NCT00161616|Drug|InductOs|InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
12054174|NCT00161603|Behavioral|Semi-structured, open-ended interviews|
12054175|NCT00161590|Drug|CHOP and alemtuzumab|
12054176|NCT00161577|Drug|Ketorolac|Intravenous ketorolac every 6 hours for 24 hours
12054177|NCT00161577|Other|Placebo|Placebo Comparator
12054178|NCT00161564|Drug|Rituximab|
12054179|NCT00161551|Device|Vitatron T70 DR|
12054180|NCT00161538|Device|Pacing leads to be implanted according randomization.|
12054181|NCT00161538|Device|Selection 9000 prevent AF an Diagnose AF|
12054182|NCT00161525|Procedure|Pneumatic displacement|Pneumatic displacement of the subretinal hemorrhages is attempted with an intravitreous injection of 0.4 ml of pure C2F6 or 2 injections of 0.2 ml on subsequent days. The gas is withdrawn from a laboratory cylinder through a millipore filter and injected into the eye through a 30 gauge needle inserted 4.0 mm posterior to the limbus in the superior temporal quadrant. The tip of the needle is monitored in the vitreous by indirect ophthalmology prior to injecting the gas.Post injections the central retinal artery is examined whether is patent.The intraocular gas expands 3.3 times over the next 3 days to create a 40% bubble.The patient is asked to assume a gaze position 40° below the horizontal for 20 minutes every hour while awake and to sleep on 2 pillows with his head turned to the right.
12054183|NCT00161486|Drug|Testosterone gel|Testosterone gel 100 mg daily for 4 weeks
12054184|NCT00161486|Drug|Acyline|Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks
12054185|NCT00161486|Drug|Placebo acyline|Placebo acyline injections every two weeks (2 doses)
12054186|NCT00161486|Drug|Placebo Testosterone gel|placebo testosterone gel daily for 4 weeks
12054187|NCT00161473|Drug|prazosin|"Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
~Duration was 8 weeks."
12054188|NCT00161473|Drug|placebo (inert substance)|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.
12054189|NCT00161460|Behavioral|colorectal cancer screening intervention|Enrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests
12054190|NCT00161447|Drug|Acyline|Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
12054191|NCT00161447|Drug|Testosterone Gel|Testosterone Gel (10 g daily
12054192|NCT00161447|Drug|Depo-Medroxyprogesterone|DMPA (injected into muscle) Day 0 & month 3
12054193|NCT00161434|Drug|valacyclovir|1 gram daily for 8 weeks
12054194|NCT00161434|Drug|placebo|matching placebo for 8 weeks
12054195|NCT00161421|Drug|Oral Testosterone|200 mg (Formulation A) Day 1 400 mg (Formulation A) Day 2, fasting; Day 3, with food 200 mg (Formulation B) Day 8, fasting 400 mg (Formulation B) Day 9, fasting; Day 10, with food
12054196|NCT00161421|Drug|Leuprolide (Lupron)|7.5 mg injection into muscle (once) (Day -14)
12054197|NCT00161421|Drug|Dutasteride|24.5 mg load (3.5 mg x 7 capsulesDay -14 only) 0.5 mg daily (Day -13 to day -1)
12054198|NCT00161408|Behavioral|cognitive behavioural therapy|
12054199|NCT00161408|Behavioral|psychoeducation|
12054200|NCT00161395|Behavioral|Instruction in the Creighton Model Fertility Care System|Instruction in the Creighton Model Fertility Care System.
12054201|NCT00161395|Behavioral|Preconception advice|Preconception advice for diet and frequency of intercourse.
12054202|NCT00161382|Behavioral|HIV, STD, and pregnancy prevention curriculum|"This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
12054203|NCT00161382|Behavioral|Standard sexual education curriculum|Control curriculum consists of standard sexual education.
12054204|NCT00161356|Drug|Ambisome|5mg/kg IV - one time dose during liver transplant
12054205|NCT00161356|Procedure|Liver Biopsy|post drug delivery (60 min. after completion of Ambisome infusion)
12054206|NCT00161343|Behavioral|Health Improvement Project for Teens on HIV Prevention|Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
12054207|NCT00161330|Drug|oral amoxicilline/clavulanic acid|
12054208|NCT00161330|Drug|iv ceftriaxone|
12054209|NCT00161317|Behavioral|Living with Hope Program|
12054210|NCT00161304|Drug|Testosterone Enanthate|
12054211|NCT00161291|Drug|Letrozole in combination with Bevacizumab|Patients will be administered Letrozole at 2.5 mg PO a day and Avastin at 15 mg/kg IV every 3 weeks for 24 weeks. Patients will then undergo surgical treatment and receive adjuvant therapy according to the treating physician.
12054212|NCT00161278|Drug|Carboplatin|
12054213|NCT00161278|Drug|Paclitaxel|
12054214|NCT00161278|Procedure|Gene expression profiling (analysis) of tumor samples|
12054215|NCT00161265|Procedure|tissue procurement|tissue procurement
12054216|NCT00161239|Drug|Doxil, Methotrexate, L-Asparaginase, Prednisone|
12054217|NCT00161226|Device|Levonorgestrel intrauterine system|
12054218|NCT00161213|Drug|gemcitabine hydrochloride|
12054219|NCT00161213|Drug|imatinib mesylate|
12054220|NCT00161200|Drug|Ranitidine & Pantoprazole|
12054221|NCT00161187|Biological|therapeutic allogeneic lymphocytes|The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.
12054222|NCT00161148|Drug|Probiotics|
12054223|NCT00161122|Biological|trivalent inactivated influenza vaccine|
12054224|NCT00161122|Biological|combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine|
12054225|NCT00161096|Drug|pantoprazole 20 mg (drug)|
12054226|NCT00161083|Drug|ursodeoxycholic acid|
12054227|NCT00161070|Drug|anticoagulation|
12054228|NCT00161070|Drug|aspirin and dipyridamole|
12054229|NCT00161070|Drug|aspirin alone|
12054230|NCT00161044|Drug|Galantamine|
12054231|NCT00161031|Drug|Atomoxetine|
12054232|NCT00161018|Drug|Quetiapine, Risperidone, Fluphenazine|
12054233|NCT00161005|Procedure|PCI|Immediate transport to invasive center after thrombolysis
12054234|NCT00160992|Biological|Melan-A analog peptide|
12054235|NCT00160979|Procedure|Pre-treatment tumour oxygen measurements|Pre-treatment tumour oxygen measurements
12054236|NCT00160966|Drug|Ciclosporin and Mycophenolate-mofetil|according to the Giessen protocol
12054237|NCT00160966|Drug|Tacrolimus and Mycophenolate-mofetil|according to Giessen protocol
12054238|NCT00160966|Drug|Tacrolimus and Mycophenolate-mofetil with change from Mycophenolate-mofetil to Everolimus|according to Giessen protocol
12054239|NCT00160953|Procedure|Endorectal Coil Magnetic Resonance Images|
12054240|NCT00160927|Device|local heating|
12054241|NCT00160927|Device|iontophoresis|
12054242|NCT00160927|Drug|actylcholine|
12054243|NCT00160927|Drug|sodium nitroprusside|
12054244|NCT00160914|Behavioral|Identification/management of childhood obesity (behavior)|In this project, we plan to conduct a national survey of pediatricians to assess common strategies for identification and management of childhood obesity, along with pediatricians' attitudes and beliefs about childhood obesity.
12054245|NCT00160901|Drug|two complex naturopathic add-on therapies, leaflet 5-a-day|
12054246|NCT00160888|Drug|sodium nitroprusside, bradykinin, acetylcholine|
12054247|NCT00160875|Drug|Irinotecan hydrochloride trihydrate|Irinotecan (65mg/m2) weeks 1-2, 4-5, 7-8
12054248|NCT00160875|Drug|Cisplatin|Cisplatin (30 mg/m2) weeks 1-2, 4-5, 7-8
12054249|NCT00160862|Drug|SLV317|
12054250|NCT00160849|Drug|Lopinavir/r|
12054251|NCT00160836|Device|"Tissue sampling (G.I.U.M. catheter)"|
12054252|NCT00160823|Procedure|Self-administered leaflet|
12054253|NCT00160797|Device|MIS™ Minimally Invasive Solutions™ TKA System|
12054254|NCT00160784|Procedure|Arthroscopy|Randomized placement into 2 groups; arthroscopic manipulation or home therapy
12054255|NCT00160784|Procedure|Arthroscopic manipulation|Manipulation of shoulder performed during arthroscopy
12054256|NCT00160784|Other|Home therapy|Shoulder exercise program performed at home that may increase shoulder function
12054257|NCT00160771|Behavioral|Joint Motion Analysis|Joint motion will be recorded for analysis.
12054258|NCT00160758|Procedure|retrieve massive allograft|Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing
12054259|NCT00160745|Drug|Rosuvastatin|
12054260|NCT00160732|Drug|Allogenic islet cells (human, U. Chicago)|Human allogenic islet cells. Immunosuppression varies but may include prograf, celcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
12054261|NCT00160732|Procedure|Intraportal infusion of islet cells|Intraportal infusion of islet cell through the portal vein in the liver.
12054262|NCT00160719|Procedure|retrieve blood samples|blood samples obtain pre-op, 6 and 12 months post-op
12054263|NCT00160706|Biological|Certolizumab Pegol (CDP870)|"Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
~Up to 84 months of therapy in this study."
12054264|NCT00160693|Biological|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
12054265|NCT00160680|Drug|Levocetirizine|"Pharmaceutical form: Tablet
~Concentration: 5 mg
~Route of administration: Oral use"
12054266|NCT00160667|Drug|Placebo|Daily oral dose of two equal intakes.
12054267|NCT00160667|Drug|Brivaracetam|Daily oral dose of two equal intakes.
12054268|NCT00160654|Drug|Levetiracetam|"Pharmaceutical form: oral tablets
~Concentration: 500 mg
~Route of administration: Oral use"
12054269|NCT00160641|Biological|Certolizumab Pegol|"Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
~Duration: Until end of study."
12054270|NCT00160628|Drug|Levetiracetam|
12054271|NCT00160615|Drug|Levetiracetam|"Pharmaceutical form: Film-coating tablets
~Concentration: 250 mg/ 500 mg
~Route of administration: oral use"
12054272|NCT00160602|Drug|Certolizumab Pegol|
12054273|NCT00160589|Drug|Levocetirizine|
12054274|NCT00160576|Drug|Levetiracetam|
12054275|NCT00160563|Drug|LEVOCETIRIZINE|5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
12054276|NCT00160563|Other|Placebo|Oral drops, bid for 18 months
12054277|NCT00160550|Drug|Levetiracetam|
12054278|NCT00160537|Drug|Levocetirizine|
12054279|NCT00160524|Biological|Certolizumab Pegol (CDP870)|Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
12054280|NCT00160511|Drug|Levetiracetam|
12054281|NCT00160498|Drug|Lercanidipine|
12054282|NCT00160485|Drug|Glyburide|dosage required to obtain adequate glucose control
12054283|NCT00160485|Drug|Insulin|variable dosage to obtain glucose control
12054284|NCT00160472|Procedure|removal of ovarian vessels|
12054285|NCT00160459|Drug|Asoprisnil|5 mg Tablet, oral Daily for 12 weeks
12054286|NCT00160459|Drug|Asoprisnil|10 mg Tablet, oral Daily for 12 weeks
12054287|NCT00160459|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 weeks
12054288|NCT00160459|Drug|Placebo|Tablet, oral Daily for 12 weeks
12054289|NCT00160446|Drug|Asoprisnil|5mg Tablet, oral Daily for 12 weeks
12054290|NCT00160446|Drug|Asoprisnil|10 mg Tablet, oral Daily for 12 weeks
12054291|NCT00160446|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 weeks
12054292|NCT00160446|Drug|Placebo|Tablet, oral Daily for 12 weeks
12054293|NCT00160433|Drug|Asoprisnil|0.5 mg Tablet, oral Daily for 12 weeks
12054294|NCT00160433|Drug|Asoprisnil|1.5 mg Tablet, oral Daily for 12 weeks
12054295|NCT00160433|Drug|Asoprisnil|5.0 mg Tablet, oral Daily for 12 weeks
12054296|NCT00160433|Drug|Placebo|Tablet, oral Daily for 12 weeks
12054297|NCT00160420|Drug|Asoprisnil|5mg Tablet, oral Daily for 12 months
12054298|NCT00160407|Drug|Orlistat (Xenical)|
12054299|NCT00160407|Behavioral|1400 kcal diet (30% fat)|
12054300|NCT00160394|Drug|Duac® Gel / Differin® Gel|
12054301|NCT00160381|Drug|Asoprisnil|10mg Tablet, oral Daily for 12 months
12054302|NCT00160381|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 months
12054303|NCT00160381|Drug|Placebo|Tablet, oral Daily for 12 months
12054304|NCT00160368|Behavioral|Potassium supplementation|
12054305|NCT00160355|Procedure|Hematopoietic stem cell transplantation|To determine the safety in regards to engraftment and toxicity within 100 days of infusing a haploidentical T- and B-cell depleted hematopoietic stem cell graft into patients with Wiskott-Aldrich syndrome who have received a reduced intensity conditioning regimen.
12054306|NCT00160355|Device|Miltenyi CliniMACS selection system|This system depletes the hematopoietic stem cell graft of T and B lymphocytes.
12054307|NCT00160355|Drug|Fludarabine, Melphalan, Thiotepa|Participants will receive a reduced intensity conditioning regimen consisting of Fludarabine, Melphalan, Thiotepa, and OKT3 prior to receipt of the haploidentical stem cell graft. Rituximab will be given in an effort to prevent PTLPD. In addition to T-cell depletion of the donor product, cyclosporine will be given for GVHD prophylaxis.
12054308|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
12054309|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
12054310|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
12054311|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
12054312|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.30 EE
12054313|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
12054314|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.45 EE
12054315|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.60 MT
12054316|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, Placebo
12054317|NCT00160329|Drug|Atazanavir|300 mg with ritonavir boosting or 400 mg without
12054318|NCT00160316|Drug|0.5 Mg Estradiol and 2.5 Mg Dydrogesterone|p.o. daily
12054319|NCT00160303|Drug|Prolotherapy|
12054320|NCT00160303|Drug|Local Corticosteroid Therapy|
12054321|NCT00160290|Drug|Lactulose|15 mL / 12 hours
12054322|NCT00160290|Drug|Plantago ovata|3,5 g / 12 hours
12054323|NCT00160277|Drug|Moxonidine|
12054324|NCT00160264|Drug|Lactulose, Vitamin D, Calcium|
12054325|NCT00160251|Drug|Boceprevir (BOC)|100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID
12054326|NCT00160251|Biological|PegIntron (PEG)|1.5 mcg/kg weekly subcutaneously
12054327|NCT00160251|Drug|Ribavirin (RBV)|200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight [weight-based dosing {WBD}])
12054328|NCT00160238|Drug|Betahistine 24 mg bid (Betaserc)|
12054329|NCT00160225|Drug|Daglutril|
12054330|NCT00160212|Drug|Daglutril|
12054331|NCT00160199|Drug|PROMETRIUM® 300 mg|300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
12054332|NCT00160199|Drug|PROMETRIUM® 400 mg|400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
12054333|NCT00160186|Drug|Pancreatin|2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 1 capsule per snack (2-3 snacks)
12054334|NCT00160186|Drug|Placebo|Placebo
12054335|NCT00160173|Drug|Estradiol|
12054336|NCT00160160|Drug|eprosartan/HCTZ|
12054337|NCT00160147|Drug|bifeprunox|One week titration with dose adjustments
12054338|NCT00160147|Drug|Placebo|Placebo
12054339|NCT00160134|Drug|SLV320|
12054340|NCT00160121|Drug|Lanthanum carbonate|
12054341|NCT00160108|Behavioral|dietary intervention|
12054342|NCT00160082|Drug|Xepol|
12054343|NCT00160069|Drug|Sagopilone (BAY86-5302, ZK 219477)|16 mg/m2, 3-hour infusion, every 3 weeks
12054344|NCT00160069|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 30-min infusion, every 3 weeks
12054345|NCT00160069|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 3-hour infusion, every 3 weeks
12054346|NCT00160056|Procedure|Hypoglycemia|
12054347|NCT00160043|Drug|SH T00268C|1250 mg experimental drug od
12054348|NCT00160043|Drug|PTK787/ ZK 222584|1250 mg experimental drug bid (500mg + 750mg)
12054349|NCT00160030|Drug|FOLFOX 4|total treatment of six 2-weekly cycles of FOLFOX 4, the first 3 cycles starting on D1, D15 and D29 concomitant with 5 weeks' radiotherapy.
12054350|NCT00160030|Drug|5-FU / Cisplatin|two cycles of 5-FU / Cisplatin on week 1 and 5 of radiotherapy and two cycles of chemotherapy with 5-FU / Cisplatin on week 8 and 11 (one cycle each three weeks after the end of radiotherapy).
12054351|NCT00160017|Behavioral|Breakthrough collaborative|Participants (professionals) participate in a Breakthrough Collaborative to improve diabetes care
12054352|NCT00160004|Behavioral|Intensive Controlled Exercise|
12054353|NCT00159991|Procedure|Total arterial revascularization|Coronary artery bypass grafting using LIMA and RIMA and/or radial artery grafts
12054354|NCT00159991|Procedure|Conventional revascularization|Coronary artery bypass grafting using LIMA and saphenous vein grafts
12054355|NCT00159978|Procedure|18F-FLT and 18F-MISO-PET|18F-FLT-PET-images will be acquired one hour after injection of 250 MBq FLT. 18F-MISO-PET: 400 MBq FMISO will be injected intravenously. Marker administration: The day before surgery (≤ 24h) pimonidazole (500 mg/m2) will be administered intravenously in 100 ml saline over 20 min. IdUrd (200 mg) will be administered as bolus injection 20 min before surgery.
12054356|NCT00159965|Drug|sertraline|flexible dose sertraline
12054357|NCT00159965|Drug|placebo|flexible dose placebo
12054358|NCT00159952|Procedure|intensive insulin therapy|"control: glycemia will be controlled with insulin administration when higher than 215 mg/dL.
~treatment: glycemia will be controlled with be controlled with insulin administration when higher than 110 mg/dL"
12054359|NCT00159939|Procedure|prone positioning|prone positioning
12054360|NCT00159926|Procedure|Cell saver|Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass
12054361|NCT00159926|Procedure|No cell saver|Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass
12054362|NCT00159913|Drug|Sildenafil citrate|oral; 20mg, 40mg and 80 mg; 3 times a day(TID)
12054363|NCT00159913|Drug|Sildenafil citrate|oral; 10mg, 20mg and 40mg; 3 times a day(TID)
12054364|NCT00159913|Drug|Placebo|oral; 3 times a day(TID)
12054365|NCT00159913|Drug|Sildenafil citrate|oral; 10 mg; 3 times a day(TID)
12054366|NCT00159900|Drug|Sildenafil Citrate|
12054367|NCT00159887|Drug|Sildenafil citrate|
12054368|NCT00159874|Drug|Sildenafil citrate|Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight >20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight >45 kg: 80 mg 3 times a day (tid)
12054369|NCT00159874|Drug|Sildenafil citrate|Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg
12054370|NCT00159874|Drug|Sildenafil citrate|Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight >20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight >45 kg: 40 mg 3 times a day (tid)
12054371|NCT00159861|Drug|Sildenafil citrate|
12054372|NCT00159848|Behavioral|Treatment Optimization Program (educational material)|
12054373|NCT00159835|Drug|atorvastatin|
12054374|NCT00159835|Drug|simvastatin|
12054375|NCT00159822|Drug|Voriconazole|"Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response.
~Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours"
12054376|NCT00159809|Drug|Viagra (Sildenafil citrate)|
12054377|NCT00159796|Drug|Asenapine|Asenapine, 3 weeks
12054378|NCT00159796|Drug|Olanzapine|Olanzapine, 3 weeks
12054379|NCT00159796|Drug|Placebo|placebo, 3 weeks
12054380|NCT00159783|Drug|asenapine|Asenapine, 40 weeks
12054381|NCT00159783|Drug|Olanzapine|Olanzapine, 40 weeks
12054382|NCT00159770|Drug|ziprasidone versus olanzapine , risperidone or quetiapine|
12054383|NCT00159770|Behavioral|Panss , CGI-C, UKU-SERS-Pa|
12054384|NCT00159770|Procedure|Blood tests|
12054385|NCT00159757|Drug|ziprazidone|
12054386|NCT00159744|Drug|Asenapine|Asenapine, 3 weeks
12054387|NCT00159744|Drug|Olanzapine|Olanzapine, 3 weeks
12054388|NCT00159744|Drug|Placebo|placebo, 3 weeks
12054389|NCT00159731|Drug|Pregabalin|
12054390|NCT00159718|Drug|amlodipine|
12054391|NCT00159718|Drug|atorvastatin|
12054392|NCT00159705|Drug|pregabalin|
12054393|NCT00159692|Drug|Amlodipine|
12054394|NCT00159679|Drug|Pregabalin|
12054395|NCT00159666|Drug|pregabalin|
12054396|NCT00159653|Drug|Xalacom|
12054397|NCT00159653|Drug|Xalatan|
12054398|NCT00159653|Drug|Timolol|
12054399|NCT00159640|Drug|PD-217,014|
12054400|NCT00159627|Drug|KW-3902IV|
12054401|NCT00159614|Drug|KW-3902IV|
12054402|NCT00159588|Drug|Betablockers or other preventive drugs|Several preventive drugs based on each individual
12054403|NCT00159575|Drug|Metformin / Placebo treatment for 4 months|M: Metformin 2000mg daily- 12-14 weeks of pretreatment + metformin 2000mg daily through conventional IVF ending on the day of pregnancy test; IE. 14 days after embryo transfer. P: Or identical placebo treatment for the same period
12054404|NCT00159562|Behavioral|individual education|individual sessions of psycho-education
12054405|NCT00159562|Behavioral|Group education|group psycho-education in 10 weekly sessions and then a session every third month for two years
12054406|NCT00159549|Behavioral|education and training program|
12054407|NCT00159536|Drug|Metformin|Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
12054408|NCT00159536|Drug|Placebo|Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
12054409|NCT00159523|Dietary Supplement|Probiotic|
12054410|NCT00159523|Biological|placebo|
12054411|NCT00159510|Drug|Methylene blue|Injection bolus of 2 mg/kg PBW and infusion of 0.2 mg/kg/hr
12054412|NCT00159510|Drug|Nitric oxide|An inhalation of NO via ETT at 10 ppm, partially weaned by 72 hrs of therapy
12054413|NCT00159510|Drug|Methylene blue & nitric oxide|See the dosage in the previous arms
12054414|NCT00159497|Device|porous coated Trilogy®|THA
12054415|NCT00159497|Device|Trilogy Calcicoat®|THA
12054416|NCT00159484|Drug|EPO906, celecoxib|EPO906 IV, every three weeks, celecoxib by mouth twice a day every day
12054417|NCT00159471|Drug|capecitabine, gemcitabine, docetaxel|
12054418|NCT00159458|Drug|Gemcitabine and oxaliplatin|
12054419|NCT00159445|Drug|gemcitabine, capecitabine|
12054420|NCT00159432|Drug|Oxaliplatin|
12054421|NCT00159432|Drug|Bevacizumab|
12054422|NCT00159432|Drug|Capecitabine|
12054423|NCT00159419|Drug|Alendronate|
12054425|NCT00159406|Other|Registry and Database|Data Collection
12054426|NCT00159393|Other|registry and database|data collection
12054427|NCT00159380|Drug|Aminoguanidine|500mg
12054428|NCT00159380|Drug|Placebos|2ml
12054429|NCT00159367|Device|Repetitive magnetic stimulation to the quadriceps|
12054430|NCT00159354|Drug|predisolone|
12054431|NCT00159341|Procedure|Nasal lavage|Nasal lavage was carried out at specified timepoints
12054432|NCT00159341|Procedure|Nasal filter paper|Nasal filter paper was placed at specified timepoints
12054433|NCT00159341|Procedure|Blood sampling|Blood sampling was performed as a routine safety check
12054434|NCT00159328|Procedure|Magnetic Resonance Guided Focused Ultrasound|
12054435|NCT00159315|Procedure|Inhalation Challenge with ATP|
12054436|NCT00159315|Procedure|Inhalation Challenge with AMP|
12054437|NCT00159302|Procedure|Induced Sputum|
12054438|NCT00159302|Procedure|Exhaled Nitric Oxide|
12054439|NCT00159302|Procedure|Nasal Nitric Oxide|
12054440|NCT00159302|Procedure|Blood Tests|
12054441|NCT00159302|Procedure|24hr Urine Samples|
12054442|NCT00159302|Procedure|Exhaled Breath Condensate|
12054443|NCT00159302|Procedure|Spirometry|
12054444|NCT00159289|Procedure|Inhalation of LPS|
12054445|NCT00159289|Procedure|Placebo|
12054446|NCT00159276|Procedure|Induced Sputum|
12054447|NCT00159263|Drug|Placebos|Dry powder inhaler
12054448|NCT00159263|Drug|Formoterol Inhalant Powder|12ug
12054449|NCT00159263|Drug|Budesonide Powder|Inhaler
12054450|NCT00159263|Drug|Budesonide and Formoterol Product|Combination Inhaler, Symbicort
12054451|NCT00159250|Drug|AVI-4658 (PMO)|morpholino antisense oligonucleotide
12054452|NCT00159237|Procedure|blood test|
12054453|NCT00159224|Drug|Lopinavir/ritonavir simplification strategy|Simplification
12054454|NCT00159211|Drug|UMULINE NPH|UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l
12054455|NCT00159211|Drug|pioglitazone|30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily
12054456|NCT00159172|Device|Motor cortex stimulation|
12054457|NCT00159159|Drug|Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l|
12054458|NCT00159159|Drug|Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l|
12054459|NCT00159146|Drug|Pindolol and venlafaxin|pindolol 20 mg and venlafaxin 150 mg
12054460|NCT00159133|Drug|antipsychotics vs. Lorazepam (Drugs)|Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;
12054461|NCT00159120|Other|maintained antipsychotic treatment vs. stepwise drug discontinuation|maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
12054462|NCT00159107|Drug|Acamprosate|Acamprosate
12054463|NCT00159107|Behavioral|Integrative behavior therapy|Integrative behavior therapy
12054464|NCT00159107|Drug|Placebo|Placebo
12054465|NCT00159094|Drug|Doxil and Vinorelbine|
12054466|NCT00159081|Drug|Haloperidol, Risperidone (drug)|targeted dose of 2-4 mg/day over 1 year
12054467|NCT00159055|Biological|CMV vaccine|
12054468|NCT00159016|Drug|Glivec|
12054469|NCT00158990|Drug|triiodothyronine|
12054470|NCT00158990|Drug|sertraline|
12054471|NCT00158977|Device|CONTAK RENEWAL 3 AVT|CONTAK RENEWAL 3 AVT
12054472|NCT00158964|Device|EASYTRAK 4 STEERABLE LV lead|
12054473|NCT00158951|Device|CONTAK RENEWAL 2/4/4HE CRT-D|
12054474|NCT00158951|Device|EASYTRAK 2 Lead|
12054475|NCT00158938|Device|EASYTRAK 3 left ventricular pacing lead|
12054476|NCT00158925|Device|EASYTRAK EPI lead|EASYTRAK EPI lead
12054477|NCT00158912|Device|Implantable Cardioverter Defibrillator|
12054478|NCT00158899|Drug|GW501516 oral tablets|
12054479|NCT00158886|Drug|Topotecan|Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.
12054480|NCT00158886|Radiation|Radiation therapy|For radiation therapy, subjects will receive 180 centigray (cGy) per fraction to a total dose of 4500 cGy to the pelvis using a 3 or 4 field technique and high energy photons (>=6 megavolt [mv]).
12054481|NCT00158873|Drug|midazolam|
12054482|NCT00158873|Drug|lorazepam|
12054483|NCT00158873|Drug|fentanyl|
12054484|NCT00158873|Drug|morphine|
12054485|NCT00158873|Drug|remifentanil|
12054486|NCT00158873|Drug|propofol|
12054487|NCT00158860|Drug|Valaciclovir|1g once daily
12054488|NCT00158860|Drug|Placebo|placebo
12054489|NCT00158847|Drug|fluticasone 500 mcg|
12054490|NCT00158847|Drug|fluticasone 500 mcg + salmeterol 50 mcg|
12054491|NCT00158834|Drug|Salmeterol/Fluticasone propionate combination product|
12054492|NCT00158834|Drug|Fluticasone propionate|
12054493|NCT00158821|Drug|Viread (tenofovir disoproxil fumarate)|Tenofovir DF 300 mg tablets once daily
12054494|NCT00158821|Drug|Sustiva (Efavirenz)|efavirenz capsules 600 mg once daily
12054495|NCT00158821|Drug|Epivir (Lamivudine)|lamivudine 150 mg tablets twice daily
12054496|NCT00158821|Drug|Zerit (Stavudine) Placebo|stavudine placebo capsules twice daily
12054497|NCT00158808|Biological|Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib|
12054498|NCT00158795|Biological|Haemophilus Influenza type b vaccine|
12054499|NCT00158782|Drug|GW786034|GW786034 (Pazopanib) is an orally active, potent, reversible, small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, VEGFR-3, platelet-derived growth factor receptor-alpha (PDGFR-alpha), PDGFR-beta, and c-Kit.
12054500|NCT00158782|Drug|lapatinib|Lapatinib is an oral, reversible, tyrosine kinase inhibitor of both epidermal growth factor receptor-1 (ErbB1) and ErbB2.
12054501|NCT00158769|Drug|Intravenous GR270773 - Phospholipid emulsion|GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.
12054502|NCT00158756|Biological|Tritanrix™-HepB|GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
12054503|NCT00158756|Biological|Rotarix™|GSK Biologicals' live attenuated human rotavirus vaccine
12054504|NCT00158756|Biological|Zilbrix™|GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
12054505|NCT00158756|Biological|Triple Antigen™|Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
12054506|NCT00158756|Biological|Engerix™-B|GSK Biologicals' hepatitis B vaccine
12054507|NCT00158756|Drug|Placebo|Placebo for the Rotarix™ vaccine
12054508|NCT00158743|Drug|Anti-digoxin antibody (FAB fragment)|intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
12054509|NCT00158743|Other|sodium chloride|
12054510|NCT00158730|Drug|AmBisome|
12054511|NCT00158717|Drug|Hepsera|
12054512|NCT00158704|Drug|Hepsera|
12054513|NCT00158691|Drug|Ethyol|
12054514|NCT00158678|Procedure|IMRT 75 Gy|50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
12054515|NCT00158678|Procedure|Conventional radiotherapy 70 Gy|50 Gy in PTV1 and 20 Gy in PTV2
12054516|NCT00158678|Drug|concomitant cisplatin|100 mg/m2 D1, D22, D43
12054517|NCT00158665|Biological|2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine|2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
12054518|NCT00158652|Procedure|Conventional radiotherapy 70 Gy in 7 weeks|2 gy per fraction, 1 fraction per day, 5 fractions per week
12054519|NCT00158652|Procedure|middle accelerated radiotherapy 70 Gy in 6 weeks|5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks
12054520|NCT00158652|Procedure|very accelerated radiotherapy 64.8 Gy in 3.5 weeks|2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks
12054521|NCT00158652|Drug|5FU, Paraplatin|5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)
12054522|NCT00158639|Behavioral|Home BP;secure messaging;pharmaceutical care;|
12054523|NCT00158626|Behavioral|pelvic floor muscle training|
12054524|NCT00158613|Biological|Carticel (autologous cultured chondrocyte) implantation|Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap
12054525|NCT00158600|Biological|alglucosidase alfa|IV infusion of 20mg/kg; qow for 78 weeks.
12054526|NCT00158600|Drug|Placebo|Placebo Comparator; qow for 78 weeks.
12054527|NCT00158587|Drug|primaquine|
12054528|NCT00158574|Drug|sulphadoxine-pyrimethamine|
12054529|NCT00158574|Drug|mefloquine|
12054530|NCT00158574|Drug|Chlorproguanil-dapsone|
12054531|NCT00158574|Drug|Placebo|Placebo
12054532|NCT00158574|Drug|Sulphadoxine-pryrimethamine|IPTi doses 1 and 2, at ages 2 and 3 months, sulphadoxine 250mg, pyrimethamine 12.5mg IPTi doses 3, at 9 months of age, sulphadoxine 500mg, pyrimethamine 25mg
12054533|NCT00158574|Drug|IPTi mefloquine|IPTi doses 1 & 2 at ages 2 & 3 months, mefloquine 125mg IPTi dose 3 at 9 months, mefloquine 250mg
12054534|NCT00158574|Drug|Chlorproguanil dapsone|IPTi doses 1 and 2 at ages 2 and 3 months, doses 15mg chlorproguanil and 18.75mg dapsone IPTi dose 3 at 9 months of age, doses 22.5mg chlorproguanil and 28.13mg dapsone
12054535|NCT00158561|Drug|sulfadoxine-pyrimethamine and chlorproguanil-dapsone|
12054536|NCT00158548|Drug|SP, chloroquine, amodiaquine, primaquine, artesunate|
12054537|NCT00158535|Procedure|liver transplantation|
12054538|NCT00158522|Drug|pegylated interferon alpha2a|
12054539|NCT00158509|Drug|Valacyclovir|
12054540|NCT00158496|Drug|pegylated interferon alpha2a|
12054541|NCT00158496|Drug|ribavirin|
12054542|NCT00158483|Drug|Acyclovir (ACV)|
12054543|NCT00158470|Drug|efavirenz|
12054544|NCT00158470|Drug|didanosine|
12054545|NCT00158470|Drug|lamivudine|
12054546|NCT00158457|Drug|Tenofovir (TDF)|
12054547|NCT00158457|Drug|Emtricitabine (FTC)|
12054548|NCT00158457|Drug|Efavirenz (EFV)|
12054549|NCT00158431|Procedure|Arthroscopy plus Medical Management|Arthroscopic Surgery
12054550|NCT00158431|Other|Medical Management|education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy
12054551|NCT00158418|Procedure|Cemented Humeral Stem|
12054552|NCT00158418|Procedure|Uncemented Humeral Stem|
12054553|NCT00158405|Procedure|Structured Treatment Interruption|
12054554|NCT00158405|Drug|Zidovudine (ZDV)|
12054555|NCT00158405|Drug|Lamivudine (3TC)|
12054556|NCT00158405|Drug|Efavirenz (EFV)|
12054557|NCT00158405|Drug|Ritonavir (NRV)|
12054558|NCT00158405|Drug|Indinavir (IDV)|
12054559|NCT00158379|Drug|Paclitaxel|4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
12054560|NCT00158366|Behavioral|Behavioral training|The behavioral training will teach participants ways to control their diet and increase their physical activity.
12054561|NCT00158366|Behavioral|Social skills training|The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.
12054562|NCT00158366|Behavioral|Behavioral training booster sessions|During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.
12054563|NCT00158353|Behavioral|GirlPOWER! mentoring program|GirlPOWER! mentoring program includes monthly 3-hour workshops for youth and mentors combined with monthly supplemental activities to be completed independently by youth-mentor pairs.
12054564|NCT00158353|Behavioral|Traditional mentoring|Traditional mentoring includes a community-based mentoring program, in which the youth-mentor spends time together in activities of their choosing 2 to 4 times a month.
12054565|NCT00158340|Behavioral|Guided self-help cognitive behavioral therapy (CBT)|Participants receive eight sessions of guided self-help CBT.
12054566|NCT00158340|Behavioral|Usual clinical care|Control group participants receive treatment as usual.
12054621|NCT00157924|Drug|atorvastatin|atorvastatin 10mg
12054622|NCT00157911|Drug|MK0653; ezetimibe / Duration of Treatment: 12 weeks|
12054623|NCT00157911|Drug|Comparator: simvastatin / Duration of Treatment: 12 weeks|
12054624|NCT00157898|Drug|MK0826; ertapenem sodium|
12054567|NCT00158327|Behavioral|Telephone-based collaborative care|Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive. The choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments. Participants will receive telephone calls one to two times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used.
12054568|NCT00158327|Behavioral|Usual care|Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians and will be delivered for 12 months.
12054569|NCT00158314|Behavioral|Referral to Gamblers Anonymous|
12054570|NCT00158314|Behavioral|Cognitive behavioral therapy|
12054571|NCT00158314|Behavioral|Cognitive behavioral self-help manual|
12054572|NCT00158301|Behavioral|Cognitive behavioral therapy (CBT)|CBT sessions will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms.
12054573|NCT00158301|Drug|Drug therapy|All participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms).
12054574|NCT00158288|Behavioral|LAAM|
12054575|NCT00158275|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.
12054576|NCT00158275|Drug|Antidepressants|Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.
12054577|NCT00158275|Behavioral|Problem solving therapy|Problem solving therapy identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment.
12054578|NCT00158262|Drug|Propranolol|Propranolol short-acting or long-acting capsule
12054579|NCT00158262|Drug|Placebo|Placebo-matching propranolol short-acting or long-acting capsule
12054580|NCT00158249|Drug|citicoline|2 gm/day, 8 weeks treatment
12054581|NCT00158249|Drug|placebo|matched for physical appearance
12054582|NCT00158236|Drug|Buprenorphine|
12054583|NCT00158236|Drug|Buprenorphine and Naloxone|
12054584|NCT00158236|Drug|Hydromorphone|
12054585|NCT00158223|Drug|Pimozide|Each capsule of active treatment will contain 2 mg of pimozide. Dosing will be flexible and will range from a minimum of 2 mg per day to 8 mg per day. Dosing will begin at Week 1 with 1 capsule per day. This will be slowly titrated at a rate of 1 capsule per week to a maximum of 4 capsules depending upon clinical response and side effects.
12054586|NCT00158223|Drug|Placebo|Active drug and placebo will be encapsulated in an identical fashion. The placebo capsule will be made to match in appearance and weight. There will be flexible dosing, allowing a minimum of 1 capsule per day to 4 capsules per day, in order to match the dosing range of the active treatment.
12054587|NCT00158210|Drug|Rivastigmine|
12054588|NCT00158197|Behavioral|contingency management voucher|participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
12054589|NCT00158184|Drug|oxycodone 15 mg|15 mg/70 kg oxycodone administered once per day, orally.
12054590|NCT00158184|Drug|oxycodone 30 mg|30 mg/70 kg oxycodone administered once per day, orally.
12054591|NCT00158184|Drug|Placebo 0 mg|0 mg placebo dose administered once a day, orally.
12054592|NCT00158171|Drug|Nicotine Replacement Therapies|Nicotine gum 2 & 4 mg dependent on baseline smoking rate
12054593|NCT00158171|Drug|Nicotine patch|21, 14 or 7 mg patch dependent on baseline smoking rate
12054594|NCT00158171|Dietary Supplement|Folic Acid|400 mg
12054595|NCT00158158|Drug|Usual Care|If unable to quit at quit date, offered usual care to set another quit date.
12054596|NCT00158158|Other|Smoking Reduction|If unable to quit smoking, reduce smoking rate prior to quit date.
12054597|NCT00158132|Drug|Propranolol|Propranolol 100mg/day in 3 divided doses
12054598|NCT00158132|Drug|Amantadine|Amantadine 100mg three times daily
12054599|NCT00158132|Drug|Placebo|Placebo pills
12054600|NCT00158119|Behavioral|InVEST (Increased Velocity Exercise Specific to Task)|
12054601|NCT00158106|Procedure|Speech and Language therapy for dysarthria and/or aphasia|
12054602|NCT00158093|Drug|Nebivolol|
12054603|NCT00158093|Drug|Atenolol|
12054604|NCT00158093|Drug|Moxifloxacin|
12054605|NCT00158080|Procedure|hemofiltration|
12054606|NCT00158067|Device|external Responsive Neurostimulator (eRNS) System|
12054607|NCT00158054|Behavioral|Enhanced depression care|Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach.
12054608|NCT00158054|Behavioral|Referred depression care|Physician notified of depression symptoms, usual care followed.
12054609|NCT00158041|Drug|Amifostine administered subcutaneously|
12054610|NCT00158028|Drug|Risperidone|The dosage of risperidone was titrated upward in a stepwise design, beginning with 0.25 mg/d for the first week, 0.5 mg/d for weeks 2 and 3, 1.0 mg/d for weeks 4 and 5, 1.5 mg/d for weeks 6 and 7, and 2.0 mg/d for the remaining weeks.
12054611|NCT00158028|Drug|Placebo|placebo match in identical tablets
12054612|NCT00158002|Drug|Topiramate|
12054613|NCT00157989|Procedure|Controlled tidal volume resuscitation|
12054614|NCT00157976|Drug|Photrex (rostaporfin)|
12054615|NCT00157963|Drug|MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks|
12054616|NCT00157950|Biological|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
12054617|NCT00157950|Biological|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
12054618|NCT00157937|Drug|MK0476; montelukast sodium/Duration of Treatment: 16 weeks|
12054619|NCT00157937|Drug|Comparator: theophylline ER/Duration of Treatment: 16 weeks|
12054620|NCT00157924|Drug|simvastatin (+) ezetimibe|simvastatin (+) ezetimibe 10/20mg.
12054625|NCT00157898|Drug|Comparator: ceftriaxone + metronidazole|
12054626|NCT00157885|Drug|Amodiaquine plus artesunate; Artekin|
12054627|NCT00157872|Drug|MK0966; rofecoxib|
12054628|NCT00157872|Drug|Comparator: naproxen tablet 500 mg|
12054629|NCT00157859|Drug|Chloroquine and sulphadoxine-pyrimethamine|
12054630|NCT00157846|Device|CRT-P or CRT-D Device|Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)
12054631|NCT00157833|Drug|Artekin / Coartemther|
12054632|NCT00157820|Device|Single Chamber Implantable Cardioverter Defibrillator|Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD
12054633|NCT00157820|Device|Dual Chamber implantable cardioverter defibrilator|Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)
12054634|NCT00157807|Procedure|bipolar radiofrequency ablation of persistent and permanent AF|
12054635|NCT00157794|Device|Search AV+ algorithm|
12054636|NCT00157781|Device|Medtronic AT500|
12054637|NCT00157768|Device|Implantable cardioverter defibrillator|
12054638|NCT00157755|Device|Enterra Therapy|Gastric electrical stimulation using Enterra Therapy.
12054639|NCT00157742|Procedure|Spinal Cord Stimulation (SCS)|
12054640|NCT00157742|Procedure|Percutaneous Myocardial Laser Revascularisation (PMR)|
12054641|NCT00157729|Drug|pyridoxal-5'-phosphate with and without ACE inhibitor|
12054642|NCT00157716|Drug|(MC-1) Pyridoxal-5'-phosphate|
12054643|NCT00157703|Drug|G207|1 x 10E9 plaque forming units, administered by stereotactic injections into the tumor (single administration)
12054644|NCT00157690|Drug|Alendronate|70 mg 1x weekly for 12 months
12054645|NCT00157690|Drug|Placebo|70 mg 1 x weekly for 12 months
12054646|NCT00157677|Procedure|D-dimer testing|Uniform D-dimer use
12054647|NCT00157677|Procedure|D-dimer testing|Selective D-Dimer use
12054648|NCT00157651|Drug|warfarin|Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
12054649|NCT00157651|Drug|placebo|matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor
12054650|NCT00157638|Behavioral|integration of pharmacist into primary care|
12054651|NCT00157638|Drug|optimizing therapeutic treatments|
12054652|NCT00157638|Behavioral|optimizing processes of care|
12054653|NCT00157625|Behavioral|Automatic stop order|
12054654|NCT00157612|Procedure|a clinical pathway nursing home acquired pneumonia|treatment in nursing homes according to a clinical pathway, which included use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, rehydrations and close monitoring by research nurse
12054655|NCT00157599|Procedure|various diagnostic measures for DVT (e.g., CUS)|
12054656|NCT00157586|Drug|Delapril, Delapril-Manidipine Fixed combination|
12054657|NCT00157573|Drug|GM-CSF, sargramostim|GM-CSF subcutaneous injection
12054658|NCT00157560|Drug|Chemotherapy, multiple agents|
12054659|NCT00157547|Drug|Selective serotonin reuptake inhibitors (SSRI)|Selective serotonin reuptake inhibitors (SSRI)
12054660|NCT00157534|Drug|Celgosivir|
12054661|NCT00157521|Drug|L-arginine|
12054662|NCT00157508|Drug|nitroaspirin|
12054663|NCT00157482|Drug|Ezetimibe|
12054664|NCT00157482|Drug|Simvastatin|
12054665|NCT00157378|Drug|Risperidone, Haloperidol|
12054666|NCT00157339|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 12 months
12054667|NCT00157339|Drug|injected insulin|patient specific dose, injected, before meals, 12 months.
12054668|NCT00157326|Drug|tadalafil|
12054669|NCT00157313|Behavioral|Integrated treatment, family involvement|
12054670|NCT00157313|Behavioral|Social skills training|
12054671|NCT00157300|Drug|Epoetin beta|intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
12054672|NCT00157287|Procedure|Evidence based weaning protocol|
12054673|NCT00157274|Drug|alemtuzumab|
12054674|NCT00157261|Drug|tenecteplase|
12054675|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
12054676|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
12054677|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
12054678|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
12054679|NCT00157235|Drug|Tiotropium bromide|
12054680|NCT00157209|Biological|Tecemotide (L-BLP25)|After receiving single low dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from the study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of the investigator, and in case of unavailability of study vaccine.
12054681|NCT00157209|Drug|Single low dose cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.
12054682|NCT00157209|Other|Best Supportive Care (BSC)|The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease.
12054683|NCT00157196|Biological|Tecemotide (L-BLP25)|After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide [L-BLP25]) at 6-week intervals, commencing at Week 13, until disease progression is documented.
12054684|NCT00157196|Drug|Single low dose cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.
12054685|NCT00157196|Other|Best standard of care (BSC)|The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.
12054686|NCT00157183|Device|Nocturnal oxygen , nocturnal bi-level positive pressure ventilation|
12054687|NCT00157170|Behavioral|supervised exercise|
12054688|NCT00157157|Biological|Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)|"Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator).
~The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care.
~For incremental recovery assessments, a single infusion at 50 +/- 5 IU/kg was to be given.
~Immune tolerance induction (ITI) therapy for subjects who developed factor VIII inhibitors was at the discretion of the investigator, based on the institution's guidelines or described in peer-reviewed literature, and was to be approved by the sponsor's medical director.
~rAHF-PFM was to be administered intravenously via bolus infusion, except for perioperative management when it may have been given either by continuous or bolus infusion."
12054689|NCT00157131|Biological|Fibrin Sealant, ARTISS 4IU/ml VH SD|FS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set.
12054690|NCT00157131|Other|Staples|Administration by mechanical/multiple point fixation.
12054691|NCT00157118|Drug|Protein C Concentrate (Human) Vapor Heated|
12054692|NCT00157105|Drug|Antihemophilic factor, recombinant, manufactured protein-free|
12054693|NCT00157092|Drug|Aerosolized, Recombinant Alpha 1-Antitrypsin|
12054694|NCT00157079|Biological|Immune Globulin Intravenous (Human), 10%|
12054695|NCT00157066|Drug|Ergocalciferol|
12054696|NCT00157053|Drug|Antihemophilic factor, recombinant, manufactured protein-free|
12054697|NCT00157040|Drug|Antihemophilic factor, recombinant, manufactured protein-free|
12054698|NCT00157027|Procedure|Extracorporeal photochemotherapy with UVADEX|"Photopheresis (or extracorporeal photoimmunetherapy [ECP]) is a process developed by THERAKOS, Inc., a Johnson and Johnson Company. During the process of ECP, whole blood is drawn from the patient over several cycles, centrifuged and separated into the components of plasma, white cells (or buffy coat), and red blood cells. A portion of the white cells and the plasma are saved in a separate compartment. The remaining plasma and red blood cells are immediately returned to the patient.
~The saved buffy coat (white blood cells) and plasma are inoculated with the photosensitizing agent UVADEX. Photoactivation begins when the suspension is exposed to a prescribed amount of ultraviolet-A light. After photoactivation is complete, the treated suspension is returned to the patient."
12054699|NCT00157014|Drug|Tacrolimus|Oral
12054700|NCT00157014|Drug|Cyclosporine|Oral
12054701|NCT00157014|Drug|Mycophenolate mofetil|Intravenous and Oral
12054702|NCT00157014|Drug|Methylprednisolone|Intravenous
12054703|NCT00157014|Drug|Prednisone|Oral
12054704|NCT00157001|Procedure|Photopheresis Post Angioplasty|
12054705|NCT00156988|Drug|cerium nitrate-silver sulfadiazine (cerium-flamazine)|
12054706|NCT00156975|Drug|Capecitabine|
12054707|NCT00156975|Drug|Oxaliplatin|
12054708|NCT00156962|Drug|Epoetin alfa DT|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
12054709|NCT00156962|Drug|Epoetin alfa RB|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
12054710|NCT00156949|Drug|Epoetin alfa DT|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
12054711|NCT00156936|Drug|Medisorb naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.
12054712|NCT00156936|Drug|Oral naltrexone to Medisorb naltrexone 380 mg|Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.
12054713|NCT00156923|Drug|Medisorb naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
12054714|NCT00156923|Drug|Medisorb naltrexone 190 mg|Administered via IM injection once every 4 weeks for up to 3.5 years.
12054715|NCT00156910|Biological|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
12054716|NCT00156910|Other|Placebo (saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
12054717|NCT00156897|Drug|ATL-962|
12054718|NCT00156897|Drug|Orlistat|
12054719|NCT00156884|Drug|strontium-89|
12054720|NCT00156884|Drug|cisplatin|
12054721|NCT00156871|Behavioral|exercise|
12054722|NCT00156858|Drug|intravenous busulfan|
12054723|NCT00156845|Procedure|AI-700 contrast-enhanced echocardiography|
12054724|NCT00156819|Drug|fluticasone|fluticasone (100 microgram twice daily) treatment
12054725|NCT00156819|Drug|montelukast|Montelukast (5 or 10 mg each night).
12054726|NCT00156819|Drug|Fluticasone plus salmeterol|fluticasone (100 microgram) plus salmeterol (50 microgram) each night
12054727|NCT00156806|Procedure|Aloe barbadensis topical application in a moisturizing cream vehicle.|
12054728|NCT00156793|Procedure|AI-700 contrast-enhanced echocardiography|
12054729|NCT00156780|Drug|AI-700|
12054730|NCT00156741|Device|Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2|
12054731|NCT00156741|Procedure|Required pacemaker setting|
12054732|NCT00156728|Device|Vitatron biventricular pacemaker|
12054809|NCT00156000|Device|Salivary Estriol|Salivary Estriol done during pregnancy
12054810|NCT00155987|Procedure|Early decompressive craniectomy|Large bifrontotemporal decompressive craniectomy
12054811|NCT00155974|Biological|Community-based vaccine outreach intervention|
12054812|NCT00155935|Procedure|venous puncture|
12054813|NCT00155883|Drug|Taxteral|
12054733|NCT00156715|Drug|Quetiapine|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
12054734|NCT00156702|Behavioral|Feedback and Motivational Interviewing|
12054735|NCT00156702|Behavioral|Smoking Prevention Video|
12054736|NCT00156689|Drug|levetiracetam|
12054737|NCT00156676|Device|Body-weight supported treadmill|
12054738|NCT00156676|Device|Lokomat|
12054739|NCT00156676|Device|Body-weight supported treadmill|
12054740|NCT00156676|Device|Lokomat|
12054741|NCT00156663|Behavioral|Caring for Women Veterans|
12054742|NCT00156650|Drug|Acyline|Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks
12054743|NCT00156650|Drug|Testosterone Gel|Testosterone (T) gel 10 g daily for 6 months
12054744|NCT00156650|Drug|Depo-Medroxyprogesterone|300 mg IM every 3 months
12054745|NCT00156637|Behavioral|Team-Based Quality Improvement Intervention|Intervention to improve recommended dosing and side effect monitoring of antipsychotic medications using a team-based quality improvement effort
12054746|NCT00156637|Behavioral|Opinion Leader Intervention|Intervention to improve recommended dosing and side effect monitoring of antpsychotic medications using an Opion leader quality improvement effort
12054747|NCT00156637|Behavioral|Team Based Quality Improvement|Intervention to increase appropriate use of clozapine through a team based quality intervention.
12054748|NCT00156624|Drug|Balloon Angioplasty with or without drug administration|
12054749|NCT00156611|Procedure|Balloon Angioplasty|
12054750|NCT00156611|Drug|ReoPro|
12054751|NCT00156572|Procedure|Sodium supplementation|
12054752|NCT00156572|Procedure|Fluid restriction|
12054753|NCT00156546|Drug|antibiotic to reduce the recurrence of infection|
12054754|NCT00156533|Drug|Zolpidem|10 mg of Zolpidem
12054755|NCT00156533|Drug|Sugar Pill|
12054756|NCT00156520|Drug|aprotonin; epsilon aminocaproic acid|
12054757|NCT00156507|Behavioral|Asthma education for parents of very low birth weight infants|Asthma education is provided to parents of children in the experimental group prior to nicu discharge.
12054758|NCT00156468|Behavioral|Provider Prompt|
12054759|NCT00156416|Behavioral|Mindfulness Meditation|8 weeks of meditation training
12054760|NCT00156403|Drug|amlodipine (drug)|
12054761|NCT00156390|Device|echo-guided left ventricular lead placement|placement of the LV lead of the biventricular pacing device under echocardiographic guidance
12054762|NCT00156390|Other|LV lead placement as per standard of care (without echo guidance)|
12054763|NCT00156377|Drug|Mupirocin|
12054764|NCT00156351|Behavioral|Physical activity promotion|
12054765|NCT00156338|Procedure|fluid management|volume and sodium restriction
12054766|NCT00156338|Procedure|fluid management|volume restriction
12054767|NCT00156338|Procedure|fluid management|liberal fluid management
12054768|NCT00156325|Drug|Escitalopram (Lexapro)|
12054769|NCT00156312|Drug|Docetaxel|
12054770|NCT00156312|Drug|Capecitabine|
12054771|NCT00156299|Drug|choline magnesium trisalicylate|1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
12054772|NCT00156299|Drug|Dexamethasone|10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.
12054773|NCT00156286|Drug|Gleevec|
12054774|NCT00156260|Procedure|Ductal lavage|
12054775|NCT00156247|Drug|acitretin|Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.
12054776|NCT00156234|Behavioral|One-knee extension ergometer|
12054777|NCT00156208|Drug|Asoprisnil|10mg Tablet, oral Daily for 18 months
12054778|NCT00156208|Drug|Asoprisnil|25 mg Tablet, oral Daily for 18 months
12054779|NCT00156195|Drug|Asoprisnil|10 mg Tablet, oral Daily for 12 months
12054780|NCT00156195|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 months
12054781|NCT00156182|Drug|Asoprisnil|10mg Tablet, oral Daily for 6 months
12054782|NCT00156169|Drug|Dunaliella|
12054783|NCT00156156|Drug|Asoprisnil|Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
12054784|NCT00156156|Drug|Asoprisnil|Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
12054785|NCT00156143|Procedure|Blood sample|
12054786|NCT00156143|Procedure|Radiography|
12054787|NCT00156130|Radiation|Conventional radiotherapy schedule|50 Gy in 25 fractions over 35 days
12054788|NCT00156130|Radiation|Accelarated radiotherapy schedule|42.5 Gy in 16 fractions over 22 days
12054789|NCT00156117|Drug|asenapine|5 mg BID or 10mg BID
12054790|NCT00156117|Drug|Placebo|Placebo
12054791|NCT00156117|Drug|olanzapine|olanzapine 15 mg QD
12054792|NCT00156104|Drug|Asenapine|5 mg BID
12054793|NCT00156104|Drug|Asenapine|10 mg BID
12054794|NCT00156104|Drug|Haloperidol|4 mg BID
12054795|NCT00156104|Other|Placebo arm|
12054796|NCT00156091|Drug|Olanzapine|5- 20 mg QD
12054797|NCT00156091|Drug|Asenapine|5 or 10 mg BID
12054798|NCT00156091|Other|Placebo|
12054799|NCT00156078|Drug|pregabalin|
12054800|NCT00156065|Drug|Haloperidol|2-8 mg BID
12054801|NCT00156065|Drug|Asenapine|5 or 10 mg BID
12054802|NCT00156065|Drug|Asenapine|5 or 10 mg BID
12054803|NCT00156052|Radiation|Conventional whole breast radiation schedule|
12054804|NCT00156052|Radiation|Hypofractionated whole breast radiation schedule|
12054805|NCT00156039|Behavioral|Follow-up Strategy for Breast Cancer|
12054806|NCT00156026|Procedure|loop electrosurgical excision procedure (LEEP)|1. loop electrosurgical excision procedure
12054807|NCT00156013|Drug|CLOFARABINE|4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles
12054808|NCT00156000|Device|Fetal Fibronectin|fFN test done during pregnancy
12054814|NCT00155883|Drug|5-Fluorouracil|
12054816|NCT00155870|Behavioral|questionnaires|
12054817|NCT00155766|Biological|HPV16 E7 peptide-pulsed autologous DCs|
12054818|NCT00155714|Drug|type-5 phosphodiesterase Inhibitor (Sildenafil)|
12054819|NCT00155675|Drug|GUSUIBU|
12054820|NCT00155662|Behavioral|work-hardening program|
12054821|NCT00155610|Device|intravesical current perception test|
12054822|NCT00155597|Behavioral|home physical therapy|
12054823|NCT00155558|Drug|5-Fluorouracil, Leucovorin|
12054824|NCT00155545|Behavioral|Motion analysis of patients|
12054825|NCT00155532|Procedure|3 mm-punch biopsies of the skin|
12054826|NCT00155493|Procedure|obtain surgical specimen for analysis|
12054827|NCT00155480|Procedure|computed tomography|
12054828|NCT00155467|Procedure|CT|
12054829|NCT00155454|Procedure|Intravitreal long acting gas (10% C3F8)|At the end of surgery, fluid-gas exchange with 10% C3F8 were done in the eye of study group
12054830|NCT00155441|Behavioral|cognitive-behavioral therapy|
12054831|NCT00155428|Procedure|rapid prototyping|
12054832|NCT00155428|Procedure|computed tomography|
12054833|NCT00155415|Behavioral|Different timing of taking polyethylene glycol(PEG)|
12054834|NCT00155402|Drug|tissue fibrin glue application (Tisseel)|Apply several droplets within several seconds to several minutes
12054835|NCT00155389|Drug|Helicobacter pylori eradication|"For subjects who received the first-line treatment, the costs included the initial 13C-UBT, one-week triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and clarithromycin 500mg twice daily), and the confirmatory 13C-UBT. For subjects in whom the initial treatment failed, the costs further included the re-treatment consisting of ten-day triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and levofloxacin 500mg once daily), and the confirmatory 13C-UBT.
~The first round of study was between 2004 and 2005, the second round was between 2008 and 2009, and the third round was between 2012 and 2013."
12054836|NCT00155376|Drug|morphine and glucagon|
12054837|NCT00155363|Device|conventional artificial kidney (AK) vs. high flux AK|
12054838|NCT00155350|Drug|pioglitazone|
12054839|NCT00155337|Procedure|photodynamic therapy|
12054840|NCT00155324|Device|Extracorporeal Shock Wave Therapy (Device)|
12054841|NCT00155311|Procedure|orthodontic treatment|
12054842|NCT00155285|Procedure|computed tomography|
12054843|NCT00155272|Drug|Thalidomide|
12054844|NCT00155259|Drug|Docetaxel , Cisplatin , Capecitabine|
12054845|NCT00155246|Drug|pentoxifylline (drug)|
12054846|NCT00155233|Drug|Nalbuphine and morphine|
12054847|NCT00155220|Device|Low Stretch Bandage and Kinesio Tape|
12054848|NCT00155064|Drug|captopril, Losartan (drug)|
12054849|NCT00154986|Procedure|immunohistochemical staining, transfection, invasion assay|
12054850|NCT00154895|Drug|intrapleural minocycline instillation|
12054851|NCT00154882|Drug|Paclitaxel (Phyxol) , Cisplatin|
12054852|NCT00154869|Drug|Peginterferon Alfa-2a plus Ribavirin|
12054853|NCT00154856|Behavioral|Detect the variation of limb lengthening|
12054854|NCT00154843|Drug|Lycopene|A: Lycopene15 mg/day ; B: Lycopene30 mg/day
12054855|NCT00154830|Behavioral|cerebral palsy|
12054856|NCT00154830|Behavioral|crouch gait|
12054857|NCT00154817|Procedure|radiotherapy|
12054858|NCT00154804|Drug|Paclitaxel, Cisplatin,Surgery, CCRT|
12054859|NCT00154791|Drug|oxaliplatin|
12054860|NCT00154791|Drug|gemcitabine|
12054861|NCT00154791|Drug|5-FU/LV|
12054862|NCT00154778|Drug|Taxol, UFT,Leucovorin|
12054863|NCT00154765|Device|sling suspension exercises|
12054864|NCT00154752|Procedure|CCRT, Pelvic lymphadenoectomy.|
12054865|NCT00154739|Drug|Gemcitabine|
12054866|NCT00154739|Drug|Cisplatin|
12054867|NCT00154739|Drug|Epirubicin|
12054868|NCT00154726|Drug|Paclitaxel-HDFL|
12054869|NCT00154713|Biological|CEA pulsed dendritic cells|
12054870|NCT00154700|Drug|Paclitaxel,Cisplatin,5-Fu,Folic Acid|
12054871|NCT00154687|Drug|Paclitaxel, Cisplatin, 5-Fluorouracil|
12054872|NCT00154674|Device|ICY catheter, Thermoguard device|
12054873|NCT00154661|Drug|pentoxifylline|
12054874|NCT00154648|Procedure|CE-MRA|
12054875|NCT00154635|Drug|DCB-AD1|
12054876|NCT00154622|Behavioral|work hardening program|
12054877|NCT00154609|Drug|Gu-Sui-Bu (Davallia Divaricata)|
12054878|NCT00154570|Device|EGG, 24 hour esophageal pH monitor|
12054879|NCT00154557|Behavioral|elite judo athletes program|
12054880|NCT00154518|Procedure|Orthodontic treatment|
12054881|NCT00154505|Device|Lateral trunk support of wheelchair seating|
12054882|NCT00154492|Drug|activated recombinant human factor VII|
12054883|NCT00154466|Behavioral|cardiac rehabilitation|Those in the training group participated in a 3-month rehabilitation training program at an exercise intensity of 55% to 70% of peak oxygen uptake (VO2); those in the nontraining group continued their usual lifestyle.
12054884|NCT00154453|Procedure|obtain surgical specimen for analysis|
12054885|NCT00154440|Drug|proton pump inhibitor|
12054886|NCT00154440|Drug|clarithromycin|
12054887|NCT00154440|Drug|amoxicillin|
12054888|NCT00154440|Drug|metronidazole|
12054889|NCT00154440|Procedure|radiation therapy|
12054890|NCT00154427|Drug|activated recombinant human factor VII|
12054891|NCT00154414|Drug|liraglutide|
12054892|NCT00154401|Drug|liraglutide|
12054893|NCT00154388|Drug|Imatinib mesylate|
12054894|NCT00154375|Drug|Imatinib mesylate|Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles.
12054895|NCT00154375|Drug|Hydroxyurea|
12054896|NCT00154362|Drug|Oxcarbazepine|
12054897|NCT00154349|Drug|Imatinib Mesylate|
12054898|NCT00154336|Drug|Imatinib|
12054899|NCT00154336|Drug|Methotrexate|
12054900|NCT00154336|Drug|Imatinib Placebo|
12054901|NCT00154323|Drug|Oxcarbazepine|
12054902|NCT00154310|Drug|Everolimus|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL.
12054903|NCT00154310|Drug|Cyclosporine|Tablets orally twice a day to maintain protocol specific target blood levels
12054904|NCT00154310|Drug|Enteric-coated mycophenolate sodium|Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day.
12054905|NCT00154310|Drug|Corticosteroids|Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
12054906|NCT00154297|Drug|Everolimus (RAD001)|
12054907|NCT00154284|Drug|Everolimus (Certican)|
12054908|NCT00154284|Drug|Cyclosporine (Neoral)|
12054909|NCT00154284|Drug|Steroid|Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
12054910|NCT00154284|Drug|Basiliximab (Simulect)|
12054911|NCT00154271|Drug|Valsartan, Valsartan HCT|
12054912|NCT00154258|Drug|Clozapine|
12054913|NCT00154245|Drug|Enteric-Coated Mycophenolate sodium (EC-MPS)|
12054914|NCT00154232|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12054915|NCT00154219|Drug|Lumiracoxib (drug)|
12054916|NCT00154206|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
12054917|NCT00154193|Drug|cyclosporine|patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.
12054918|NCT00154180|Drug|Conjugated equine estrogens 0.45 mg/day|Pill, 1 pill taken daily each month for the study duration
12054919|NCT00154180|Drug|Transdermal estradiol, 50 mcg/day|Patch; 1 patch is applied to the skin weekly. Patch site is rotated on a weekly basis.
12054920|NCT00154180|Drug|Micronized progesterone, 200 mg/day x 12 d/month|capsule, 1 capsule taken daily for the first 12 days of each month for the study duration
12054921|NCT00154180|Drug|CEE , progesterone, estradiol patch or placebo for each|CEE 0.45mg 1 PO QD Progesterone 200 mg 1 PO HS first 12 days of the month estradiol patch use 1 per week
12054922|NCT00154180|Drug|CEE, progesterone, transdermal patch or the placebo|CEE 0.45 mg 1 PO QD or placebo equivalent Prometrium 200 mg 1 PO qHS for first 12 dasy of each month or placebo equivalent transdermal patch 0.05 mg use 1 patch per week or placebo equivalent
12054923|NCT00154167|Drug|NV-101 (phentolamine mesylate solution)|
12054924|NCT00154154|Behavioral|General Psychiatric Management|General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.
12054925|NCT00154154|Behavioral|Dialectical Behaviour Therapy|Modification of behaviours achieved with reframing thoughts and impulses
12054926|NCT00154141|Drug|Fibrin sealant (FS2)|
12054927|NCT00154128|Device|occlusal appliance|
12054928|NCT00154115|Drug|levosimendan|Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
12054929|NCT00154115|Drug|placebo|Placebo
12054930|NCT00154102|Drug|Cetuximab|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Number of Cycles: until progression or unacceptable toxicity develops
12054931|NCT00154102|Drug|FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
12054932|NCT00154089|Drug|EM-1421|EM-1421 administered intravaginally every 3 weeks as 45 mg (1% w/w) EM-1421 or 90 mg (2% w/w) EM-1421
12054933|NCT00154076|Drug|Zonisamide|Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
12054934|NCT00154076|Drug|Topiramate|Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.
12054935|NCT00154063|Drug|E2007|
12054936|NCT00154063|Other|Placebo|
12054937|NCT00154050|Drug|candesartan (drug) or quinapril (drug)|
12054938|NCT00154037|Drug|Pioglitazone (drug) and/or candesartan (drug)|
12054939|NCT00154024|Drug|atorvastatin|
12054940|NCT00154024|Drug|irbesartan|
12054941|NCT00154011|Drug|rosiglitazone (drug)|
12054942|NCT00153998|Drug|Cetuximab|
12054943|NCT00153998|Procedure|Liver resection|
12054944|NCT00153998|Drug|Cetuximab and FOLFIRI|"Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by:
~Cetuximab 250 mg/m² (1.0 h i.v.) weekly
~Irinotecan 180 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)"
12054945|NCT00153998|Drug|Cetuximab and FOLFOX|"Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by:
~Cetuximab 250 mg/m² (1.0 h i.v.) weekly
~Oxaliplatin 100 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)"
12054946|NCT00153985|Drug|Busulfex|Given once daily for 4 days
12054947|NCT00153985|Drug|Fludarabine|Given intravenously once daily for 4 days
12054948|NCT00153985|Drug|Alemtuzumab|One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days.
12054949|NCT00153985|Procedure|Stem Cell Transfusion|Performed three days after the end of chemotherapy
12054950|NCT00153972|Drug|Cabergoline|
12054951|NCT00153972|Drug|Levodopa|
12054952|NCT00153959|Behavioral|acute psychiatric day care|
12054953|NCT00153946|Drug|Edaravone|30mg/20mL vial, twice per day, not longer than two weeks
12054954|NCT00153933|Drug|Bortezomib|Given intravenously on days 1, 2, 8, 11 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
12054955|NCT00153933|Drug|CC-5013|Orally on days 1-14 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
12054956|NCT00153920|Drug|bortezomib|
12054957|NCT00153907|Drug|Navelbine|Given orally on day 1 and 8 of each cycle, dose will vary. If participant is at highest dose they will take navelbine on day 1, 8 and 15 until disease progression or unacceptable side effects occur.
12054958|NCT00153907|Drug|Capecitabine|Taken twice a day on days 1-14 until disease progression or unacceptable side effects occur.
12055019|NCT00153361|Behavioral|Video Discussion Group|
12055020|NCT00153348|Behavioral|Women's health|
12054959|NCT00153894|Behavioral|Strength training|One-on-One training with a personal trainer for 50 minutes twice a week using Nautilus machines for 16 weeks.
12054960|NCT00153894|Behavioral|Endurance training|Cardiovascular training at home for 30 minutes three times per week for 16 weeks.
12054961|NCT00153881|Drug|Capecitabine (Xeloda)|"Neoadjuvant Chemotherapy:
~Docetaxel every 3 weeks for 2 cycles Carboplatin every 3 weeks for 2 cycles with prophylactic antibiotics and antiemetics as needed.
~Concomitant chemotherapy and radiation:
~Docetaxel weekly for 5 doses without premedication Capecitabine orally, one dose prior to each fraction of irradiation (28 cycles)."
12054962|NCT00153868|Drug|darbepoetin alfa|The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience <1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations >13.0 g/dL.
12054963|NCT00153842|Drug|Bexarotene (targretin)|"Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).
~Level 1: 300 mg"
12054964|NCT00153842|Drug|Bexarotene (targretin)|"Bexarotene oral capsules will be administered daily beginning on the intitial day of chemotherapy (Day 1).
~Level 2: 400 mg"
12054965|NCT00153829|Behavioral|Multifaceted outreach facilitation for chronic illness care|
12054966|NCT00153816|Drug|Calcium Carbonate|3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
12054967|NCT00153816|Drug|Vitamin D3|1000 IU/daily; two tablets per day; 500 IU per tablet
12054968|NCT00153816|Drug|placebo|placebo; two tablets per day
12054969|NCT00153803|Drug|Erlotinib (tarceva)|Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
12054970|NCT00153803|Drug|Placebo|Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
12054971|NCT00153790|Drug|PhosphoLean|
12054972|NCT00153777|Drug|Cellulose Sulfate gel (6%)|
12054973|NCT00153764|Drug|Cooper Complete One-A-Day Vitamin Supplement|
12054974|NCT00153751|Drug|Traditional Chinese Medicine|They are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo.
12054975|NCT00153751|Drug|Holopon|holopon
12054976|NCT00153751|Other|placebo|placebo
12054977|NCT00153738|Drug|phytosterol|
12054978|NCT00153725|Drug|Aspirin and Pantoloc|
12054979|NCT00153699|Drug|Topiramate|
12054980|NCT00153686|Procedure|capsule endoscopy|capsule endoscopy of small intestine
12054981|NCT00153686|Procedure|Mesenteric Angiogram|Mesenteric Angiogram
12054982|NCT00153673|Drug|celecoxib|Celecoxib 200mg bd
12054983|NCT00153673|Drug|Dologesics|Dologesics 2 tablets bd
12054984|NCT00153660|Drug|Celecoxib(drug)|Celecoxib 100 mg bd
12054985|NCT00153660|Drug|Naproxen(drug)|Naproxen 500 mg bd
12054986|NCT00153647|Procedure|Cap-assisted colonoscopy|Cap-assisted colonoscopy
12054987|NCT00153647|Procedure|Cap-assisted colonoscopy|Cap-assisted colonoscopy
12054988|NCT00153634|Drug|IV amikacin|5-7.5 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
12054989|NCT00153634|Drug|PO azithromycin|250 mg once daily
12054990|NCT00153634|Drug|IV ceftazidime|50 mg/kg every 8 hours, up to 2 grams every 8 hours
12054991|NCT00153634|Drug|PO ciprofloxacin|500 mg every 12 hours if weight <50 kg 750 mg every 12 hours if weight ≥50 kg
12054992|NCT00153634|Drug|IV meropenem|40 mg/kg every 8 hours, up to 2 grams every 8 hours
12054993|NCT00153634|Drug|IV piperacillin-tazobactam|100 mg/kg of piperacillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
12054994|NCT00153634|Drug|IV ticarcillin-clavulanate|100 mg/kg of ticarcillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
12054995|NCT00153634|Drug|IV tobramycin|2.5-3.3 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
12054996|NCT00153608|Biological|WT1 126-134 peptide|
12054997|NCT00153595|Drug|EWO1|
12054998|NCT00153582|Biological|WT1 126-134 peptide|
12054999|NCT00153569|Biological|Tyrosinase, MAGE-3, GnTV|
12055000|NCT00153556|Biological|Hib conjugate vaccine (HbOC, Wyeth Vaccines)|
12055001|NCT00153543|Biological|Pneumococcal polysaccharide vaccine|
12055002|NCT00153543|Biological|Pneumococcal conjugate vaccine|
12055003|NCT00153530|Drug|methotrexate|"chemotherapy with radiotherapy
~chemotherapy without radiotherapy"
12055004|NCT00153530|Radiation|radiotherapy|whole-brain irradiation
12055005|NCT00153517|Drug|oral versus vaginal metronidazole|
12055006|NCT00153504|Behavioral|Housing and Health Study housing rental assistance|
12055007|NCT00153504|Behavioral|Standard local practice housing assistance|
12055008|NCT00153491|Drug|artemether-lumefantrine|
12055009|NCT00153478|Behavioral|Brief Motivational Counseling|
12055010|NCT00153465|Behavioral|Motivational intervention, parent training|
12055011|NCT00153452|Behavioral|perpetration of intimate partner violence|
12055012|NCT00153439|Behavioral|Motivational enhancements, parent training|
12055013|NCT00153426|Behavioral|West Virginia WISEWOMAN|Print-based tailored health communications and computer-based interactive nutrition program
12055014|NCT00153413|Behavioral|Women's health|
12055015|NCT00153400|Behavioral|Women's health|
12055016|NCT00153387|Behavioral|Women's health|
12055017|NCT00153374|Behavioral|Women's health|
12055018|NCT00153361|Behavioral|Discussion Group|
12055021|NCT00153335|Behavioral|patient-provider interaction|
12055022|NCT00153322|Behavioral|Nurtition and Physical Activity Education|
12055023|NCT00153309|Behavioral|People with Arthritis Can Exercise|
12055024|NCT00153296|Drug|Carbamazepine|
12055025|NCT00153283|Drug|Gabapentin|
12055026|NCT00153270|Drug|Sodium Valproate|
12055027|NCT00153257|Device|Ugytex|Anterior repair reinforced by a specially designed mesh: UgytexTM
12055028|NCT00153244|Drug|Lamotrigine|
12055029|NCT00153231|Device|IVS|Infracoccygeal sacropexy
12055030|NCT00153231|Procedure|Sacrospinofixation|
12055031|NCT00153205|Behavioral|computerized physician order entry|
12055032|NCT00153192|Drug|Marinol (dronabinol)|
12055033|NCT00153179|Drug|acipimox|subjects will receive acipimox 250 mg orally every 6 hours (or matching placebo) for 7 days, including a dose at 6am on the morning of the study testing visit
12055034|NCT00153179|Drug|placebo|matching placebo
12055035|NCT00153166|Drug|atorvastatin and pioglitazone|atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)
12055036|NCT00153166|Drug|atorvastatin/placebo|atorvastatin 80 mg orally once daily and matching placebo orally twice daily
12055037|NCT00153166|Drug|pioglitazone/placebo|pioglitazone 30 mg orally once daily and matching placebo orally once daily
12055038|NCT00153166|Drug|placebo/placebo|placebo orally three times daily
12055039|NCT00153153|Drug|polyethyleneglycol3350|
12055040|NCT00153140|Drug|polyethyleneglycol3350|
12055041|NCT00153127|Drug|polyethyleneglycol3350|
12055042|NCT00153114|Drug|polyethyleneglycol3350|
12055043|NCT00153101|Drug|Telmisartan|
12055044|NCT00153101|Drug|Combination of Telmisartan and Ramipril|
12055045|NCT00153101|Drug|Ramipril|
12055046|NCT00153088|Drug|Telmisartan capsule 40 mg|
12055047|NCT00153088|Drug|Placebo|
12055048|NCT00153088|Drug|Telmisartan capsule 80 mg|
12055049|NCT00153075|Device|Berodual Respimat|
12055050|NCT00153075|Device|Berodual HFA-MDI|
12055051|NCT00153062|Drug|Aggrenox|25mg aspirin, 200 mg dipyridamole
12055052|NCT00153062|Drug|Aggrenox|25mg aspirin, 200 mg dipyridamole
12055053|NCT00153062|Drug|Clopidogrel placebo|placebo
12055054|NCT00153062|Drug|Clopidogrel placebo|placebo
12055055|NCT00153062|Drug|Micardis|80 mg micardis
12055056|NCT00153062|Drug|Micardis|80 mg micardis
12055057|NCT00153062|Drug|Aggrenox placebo|placebo
12055058|NCT00153062|Drug|Aggrenox placebo|placebo
12055059|NCT00153062|Drug|Clopidogrel|75 mg clopidogrel
12055060|NCT00153062|Drug|Clopidogrel|75 mg clopidogrel
12055061|NCT00153062|Drug|Micardis placebo|placebo
12055062|NCT00153062|Drug|Micardis placebo|placebo
12055063|NCT00153049|Drug|Telmisartan|
12055064|NCT00153049|Drug|Hydrochlorothiazide|
12055065|NCT00153049|Drug|Telmisartan + Hydrochlorothiazide|
12055066|NCT00153036|Drug|rt-PA 0.9 mg/kg verum or placebo Intravenous|
12055067|NCT00153023|Drug|Telmisartan|
12055068|NCT00153023|Drug|Valsartan|
12055069|NCT00153010|Drug|NS 2330 (Tesofensine)|
12055070|NCT00152997|Drug|Pramipexole 0.125 mg tablets|
12055071|NCT00152997|Drug|Pramipexole 0.125 mg tablets Placebo|
12055072|NCT00152984|Drug|Tiotropium inhalation capsules|
12055073|NCT00152984|Drug|Placebo inhalation capsules|
12055074|NCT00152971|Drug|Dabigatran Dose 1 - day 2 to completion|low dose regimen taken once daily
12055075|NCT00152971|Drug|Dabigatran Dose 1 - day 1|low dose regimen taken once daily
12055076|NCT00152971|Drug|Dabigatran Dose 2 - day 2 to completion|high dose regimen taken once daily
12055077|NCT00152971|Drug|Dabigatran Dose 2 - day 1|high dose regimen taken once daily
12055078|NCT00152971|Drug|Enoxaparin|30 mg subcutaneously twice daily
12055079|NCT00152958|Drug|Pramipexole|
12055080|NCT00152945|Drug|Intravenous Intralipid|intravenous infusion
12055081|NCT00152945|Drug|Intravenous leucine, glycerol|intravenous infusion
12055082|NCT00152932|Drug|Dorzolamide 2% drops|
12055083|NCT00152932|Device|HRF and CLBF|
12055084|NCT00152919|Drug|Meloxicam|
12055085|NCT00152906|Procedure|Stereotactic radiotherapy (SRT) or highly conformal (CRT)|SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions.
12055086|NCT00152893|Drug|chromium nicotinate|
12055087|NCT00152893|Drug|Placebo|
12055088|NCT00152867|Drug|Dexamethasone|dexamethasone 4mg PO bd for 2 days post chemotherapy
12055089|NCT00152854|Drug|Acetaminophen|acetaminophen 1g po qid
12055090|NCT00152854|Drug|acetaminophen|acetaminophen 1g po qid for 7 days
12055091|NCT00152854|Drug|placebo, sugar pill|
12055092|NCT00152841|Drug|Iron supplement 300-600 mg/day|
12055093|NCT00152841|Drug|Vitamin E 800IU|
12055094|NCT00152828|Drug|Celecoxib|
12055095|NCT00152815|Drug|antioxidant vitamin E|Vitamin E 800IU per day for 12 months
12055096|NCT00152815|Behavioral|weight reduction and exercise|Patients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week.
12055097|NCT00152802|Biological|The polysaccharide vaccine Pneumovax (Merck-Frosst)|
12055098|NCT00152802|Biological|The conjugate vaccine used will be Prevnar (Wyeth vaccines)|
12055099|NCT00152789|Procedure|Oxygen measurement - Eppendorf machine|
12055100|NCT00152776|Drug|ovaria comp 10 globuli 3 times per day 24 weeks|order of intervention and placebo varies between Groups I-III
12055101|NCT00152763|Behavioral|Cognitive Behaviour Therapy (CBT)|Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
12055169|NCT00152269|Drug|Asoprisnil|25mg Tablet, oral Daily for 12 months
12055170|NCT00152269|Drug|Placebo|Placebo, Tablet, oral Daily for 12 months
12055102|NCT00152763|Other|Usual Cardiac Care (UCC)|Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
12055103|NCT00152750|Drug|APO-clonidine|
12055104|NCT00152737|Procedure|Exercise test with Transcutaneous oxygene pressure|Ce marked devices
12055105|NCT00152737|Procedure|Ankle and arm pressure values|one test before and one test after surgery
12055106|NCT00152724|Device|pressure strain system, iontophoresis|
12055107|NCT00152724|Drug|scopolamin|
12055108|NCT00152724|Drug|emla|
12055109|NCT00152724|Drug|capsaicin|
12055110|NCT00152724|Drug|aspirin|
12055111|NCT00152724|Drug|clopidogrel|
12055112|NCT00152724|Drug|celecoxib|
12055113|NCT00152724|Drug|indomethacin|
12055114|NCT00152724|Drug|acetylcholine|
12055115|NCT00152724|Drug|sodium nitroprusside|
12055116|NCT00152724|Drug|brethyllium|
12055117|NCT00152724|Device|general and local heating|
12055118|NCT00152711|Device|nCPAP|
12055119|NCT00152698|Drug|Irbesartan|
12055120|NCT00152685|Drug|human serum albumin|
12055121|NCT00152672|Device|nCPAP vs oral appliance|
12055122|NCT00152659|Procedure|Tissue sample (procedure/screening)|Tissue sampling
12055123|NCT00152646|Drug|placebo, aspirine, clopidogrel|
12055124|NCT00152633|Drug|Losartan|
12055125|NCT00152633|Drug|Metoprolol|
12055126|NCT00152633|Drug|Losartan|Treatment with Losartan
12055127|NCT00152620|Drug|Dexamethasone|
12055128|NCT00152620|Drug|Methylprednisolone|
12055129|NCT00152607|Procedure|donor right hepatic lobectomy|
12055130|NCT00152594|Drug|voriconazole|
12055131|NCT00152581|Drug|Pegylated interferon-alfa2a (Pegasys); ribavirin|
12055132|NCT00152568|Behavioral|Car Seat Check (behavior)|At time of well child visit, family receives the services of a certified child passenger safety technician, including assessment, car seat distribution if needed and training.
12055133|NCT00152555|Behavioral|Physical Therapy or Relaxation Therapy|
12055134|NCT00152542|Drug|Inhaled nitric oxide|1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
12055135|NCT00152542|Drug|Placebo|No iNO given for days 1-7
12055136|NCT00152529|Behavioral|Screening (Behavior)|
12055137|NCT00152516|Drug|levetiracetam (LEV)|Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
12055138|NCT00152503|Drug|Seletracetam (ucb 44212)|
12055139|NCT00152490|Drug|Certolizumab Pegol (CDP870)|
12055140|NCT00152477|Drug|Carboplatin|"10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle.
~Each cycle to be repeated every three weeks for a maximum of six cycles."
12055141|NCT00152477|Drug|Paclitaxel|6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
12055142|NCT00152477|Drug|CDP791 10mg/kg|CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
12055143|NCT00152477|Drug|CDP791 20mg/kg|CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
12055144|NCT00152464|Drug|Placebo|Pharmaceutical form: Oral drops Route of administration: Oral use
12055145|NCT00152464|Drug|Levocetirizine|Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
12055146|NCT00152451|Drug|Seletracetam (ucb 44212)|
12055147|NCT00152438|Drug|Oral Micronized Progesterone (Prometrium®)|300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.
12055148|NCT00152438|Other|Placebo|3 identical placebo pills daily, no active ingredient.
12055149|NCT00152425|Drug|Certolizumab Pegol (CDP870)|
12055150|NCT00152412|Drug|Levocetirizine oral solution|
12055151|NCT00152399|Drug|Somatostatin UCB (drug)|
12055152|NCT00152386|Drug|Certolizumab pegol (CDP870)|
12055153|NCT00152373|Drug|Levetiracetam|
12055154|NCT00152360|Drug|Orlistat|See Detailed Description.
12055155|NCT00152347|Drug|Botox|See Detailed Description
12055156|NCT00152334|Drug|Botox|All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.
12055157|NCT00152321|Behavioral|Patients (education, counseling) and Physicians (reminders,1-page guidelines).|
12055158|NCT00152321|Behavioral|Multifaceted intervention|Educational materials, counseling, opinion leader based guidelines, reminders
12055159|NCT00152321|Other|Usual Care|
12055160|NCT00152308|Device|2% rapamycin-eluting YUKONdes PEARL-stent|
12055161|NCT00152308|Device|1% rapamycin-eluting YUKONdes PEARL-stent|
12055162|NCT00152308|Device|YUKONdes PEARL-stent coated with placebo (ethanol)|
12055163|NCT00152295|Drug|Asoprisnil/Premarin|10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months
12055164|NCT00152282|Drug|Asoprisnil/Premarin|Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
12055165|NCT00152282|Drug|Asoprisnil/Premarin|Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
12055166|NCT00152282|Drug|Asoprisnil/Premarin|Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
12055167|NCT00152282|Drug|Placebo and Premarin|Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
12055168|NCT00152269|Drug|Asoprisnil|10mg Tablet, oral Daily for 12 months
12055339|NCT00150995|Drug|Tetrathiomolybdate|
12055171|NCT00152256|Drug|Asoprisnil|Asoprisnil 10 mg Tablet, oral Daily for 6 months
12055172|NCT00152256|Drug|Asoprisnil|Asoprisnil 25mg Tablet, oral Daily for 6 months
12055173|NCT00152256|Drug|Placebo|Placebo Tablet, oral Daily for 6 months
12055174|NCT00152243|Drug|UFT (uracil, tegafur)|uracil-tegafur 360 mg per square meter per day orally 16 months
12055175|NCT00152243|Procedure|Surgery alone|Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.
12055176|NCT00152230|Drug|UFT (uracil, tegafur)|to receive oral uracil-tegafur 400 mg square meter for one year
12055177|NCT00152230|Procedure|Surgery alone|Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
12055178|NCT00152217|Drug|TS-1 (S-1)|80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks
12055179|NCT00152217|Procedure|Surgery|Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only
12055180|NCT00152204|Drug|Sulfadoxine-pyrimethamine used for IPTi|Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
12055181|NCT00152204|Drug|IPTi|Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
12055182|NCT00152191|Drug|UFT (uracil, tegafur)|uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
12055183|NCT00152191|Drug|cyclophosphamide, methotrexate, and fluorouracil|cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8
12055184|NCT00152178|Drug|UFT (uracil, tegafur) and tamoxifen|UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.
12055185|NCT00152178|Drug|CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen|CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.
12055186|NCT00152165|Procedure|Radiostereometric Analysis beads inserted during surgery|
12055187|NCT00152152|Procedure|Radiostereometric Analysis beads inserted during surgery|
12055188|NCT00152139|Procedure|Allogeneic Stem Cell Transplantation|An infusion of HLA matched unrelated bone marrow or peripheral blood stem cells.
12055189|NCT00152139|Drug|Chemotherapy and antibodies|Participants received a standard conditioning regimen consisting of total body irradiation, cyclophosphamide, thiotepa and ATG. GVHD prophylaxis consisted of cyclosporine and Methotrexate.
12055190|NCT00152126|Procedure|Stem Cell Transplantation|Autologous stem cell transplantation
12055191|NCT00152126|Drug|Busulfan, Melphalan|Transplant recipients will receive high dose Busulfan and Melphalan followed by autologous CD133+ antigen specific hematopoietic stem cell infusion. The autologous graft product will be selected using the investigational CliniMACS device.
12055192|NCT00152113|Procedure|Hematopoietic Stem Cell Transplantation|Allogeneic stem cell transplant Haploidentical stem cell transplant Mismatched family member donor stem cell transplant T cell selection CD34 enrichment
12055193|NCT00152113|Device|CliniMACS|
12055194|NCT00152113|Drug|See intervention description|Hydroxyurea and azathioprine were administered for a 3 month period prior to the initiation of the transplant procedure in an effort to help prevent rejection of the donor product. Approximately 10 days prior to the transplant procedure, all participants received the same preparative regimen consisting of Busulfan, cyclophosphamide, low-dose thiotepa, and OKT3. MMF was administered for GVHD prophylaxis. Two separate infusions of donor stem cells were administered with fixed doses of CD3 and CD34 cells. These haploidentical stem cells were processed using the investigational CliniMACS device.
12055195|NCT00152100|Procedure|Stem cell transplant|
12055196|NCT00152100|Drug|Filgrastim, Alemtuzumab|
12055197|NCT00152100|Device|Miltenyi CliniMACS|
12055198|NCT00152087|Device|Brachytherapy|
12055199|NCT00152074|Behavioral|Reduce salt intake|
12055200|NCT00152061|Drug|3TC and FTC|
12055201|NCT00152048|Drug|Eflornithine hydrochloride|
12055202|NCT00152035|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.|
12055203|NCT00152022|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.|
12055204|NCT00152009|Drug|SPD503 (Guanfacine hydrochloride) (2 mg)|
12055205|NCT00152009|Drug|SPD503 (3 mg)|
12055206|NCT00152009|Drug|SPD503 (4 mg)|
12055207|NCT00152009|Drug|Placebo|
12055208|NCT00151996|Drug|Methylphenidate + SPD503 (Guanfacine hydrochloride)|
12055209|NCT00151996|Drug|Amphetamine + SPD503|
12055210|NCT00151983|Drug|Methylphenidate Transdermal System|To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
12055211|NCT00151970|Drug|Methylphenidate Transdermal System|MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
12055212|NCT00151970|Drug|Placebo|Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
12055213|NCT00151970|Drug|Concerta|CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
12055214|NCT00151957|Drug|Methylphenidate Transdermal System|MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
12055215|NCT00151944|Drug|SPD476 (mesalazine)|
12055216|NCT00151931|Drug|Lanthanum carbonate|
12055217|NCT00151918|Drug|Lanthanum carbonate|
12055218|NCT00151905|Drug|3 % hypertonic saline|
12055219|NCT00151892|Drug|SPD476|2.4 g/day Once Daily (QD)
12055220|NCT00151892|Drug|Asacol|1.6g/day administered 800 mg Twice Daily (BID)
12055221|NCT00151879|Drug|SPM 927|
12055222|NCT00151866|Procedure|platelet transfusion|
12055223|NCT00151853|Drug|PPSB-SD|
12055224|NCT00151840|Drug|IVIG-L|
12055225|NCT00151827|Drug|Olmesartan medoxomil|Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
12055226|NCT00151827|Drug|Losartan|Medications are taken once daily before breakfast with water.
12055227|NCT00151827|Drug|Furosemide oral tablets|If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator
12055228|NCT00151814|Drug|Olmesartan medoxomil|Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.
12055229|NCT00151801|Drug|estroprogestins|
12055230|NCT00151801|Drug|interferon-beta 1a|
12055231|NCT00151788|Drug|Pactimibe sulfate|
12055232|NCT00151775|Drug|olmesartan medoxomil|"Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension.
~Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily"
12055233|NCT00151775|Drug|placebo|Cohorts A, B, C: placebo, once daily
12055234|NCT00151775|Drug|olmesartan medoxomil|"Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly.
~Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg"
12055235|NCT00151762|Drug|Colesevelam hydrochloride|
12055236|NCT00151749|Drug|Colesevelam hydrochloride|
12055237|NCT00151736|Drug|Chlorambucil|Chlorambucil 2mg tablets
12055238|NCT00151736|Drug|R-etodolac + chlorambucil|R-etodolac 600mg tablets + chlorambucil 2mg tablets
12055239|NCT00151723|Procedure|treatment with 131I|
12055240|NCT00151710|Drug|Pioglitazone|
12055241|NCT00151697|Drug|Novomix 30|
12055242|NCT00151697|Drug|Novorapid and Amaryl|
12055243|NCT00151697|Drug|Lantus|
12055244|NCT00151684|Drug|Diazoxide|
12055245|NCT00151671|Drug|Oral Impact®|Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
12055246|NCT00151671|Drug|Placebo|Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
12055247|NCT00151658|Device|Coronary Drug Eluting Stents for PCI|
12055248|NCT00151645|Drug|activated lymphocytes|
12055249|NCT00151632|Drug|Mycophenolate mofetil|Mycophenolate mofetil is administered at a dose of 1,5 g x 2 / day for the 6 first weeks, then 1g x 2 / day until M12.
12055250|NCT00151632|Drug|Tacrolimus|"In arm 1: Tacrolimus is administered at half recommended dose: 0,040 mg/Kg x 2 , in order to maintain plasma levels between 6 and 10 ng/ml for the 6 first weeks, between 5 and 8 ng/ml from week 7 to M6 and between 4 and 6 ng/ml between M6 and M12.
~In arm 2: Tacrolimus is administered at the recommended dose: 0,075 mg/Kg x 2 , in order to maintain plasma levels between 12 and 20 ng/ml for the 6 first weeks, between 10 and 15 ng/ml from week 7 to week 12, between 8 and 12 ng/ml between M4 and M6 and between 6 and 10 ng/ml between M6 and M12."
12055251|NCT00151619|Drug|Amlodipine|
12055252|NCT00151606|Procedure|Reinforced isolation + Muciprocine|
12055253|NCT00151593|Other|Celsior®|Graft preservation solution
12055254|NCT00151580|Drug|Ribavirin|18 months of oral ribavirin maintenance treatment
12055255|NCT00151580|Drug|Placebo|18 months oral placebo treatment
12055256|NCT00151567|Drug|Tamsulosin|Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
12055257|NCT00151567|Drug|Placebo|Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
12055258|NCT00151554|Behavioral|ICU-specific information program|The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU in addition to standard information given by surgeons and anesthetists.
12055259|NCT00151541|Drug|Dapsone Topical Gel + adapalene gel 0.1%|
12055260|NCT00151541|Drug|Dapsone Topical Gel + benzoyl peroxide gel 4%|
12055261|NCT00151541|Drug|Dapsone Topical Gel + vehicle control|
12055262|NCT00151528|Drug|Pregabalin|
12055263|NCT00151515|Drug|minoxidil|Topical 5% minoxidil foam, BID, for sixteen weeks
12055264|NCT00151502|Drug|Atorvastatin|
12055265|NCT00151489|Drug|pregabalin|
12055266|NCT00151489|Drug|placebo|
12055267|NCT00151476|Drug|Celecoxib|800 mg total daily dosing
12055268|NCT00151476|Other|Routine Medical Care|
12055269|NCT00151463|Drug|sildenafil citrate|
12055270|NCT00151450|Drug|Pregabalin|
12055271|NCT00151450|Drug|Venlafaxine XR|
12055272|NCT00151437|Drug|Pegvisomant treatment|
12055273|NCT00151437|Procedure|Medical History, demographics|
12055274|NCT00151437|Procedure|Sign and symptoms: questionnaire|
12055275|NCT00151437|Procedure|Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT|
12055276|NCT00151437|Procedure|MRI|
12055277|NCT00151424|Drug|asenapine|Asenapine 5-10mgBID
12055278|NCT00151424|Drug|Placebo|Matched against asenapine and olanzapine
12055279|NCT00151424|Drug|Olanzapine|10-20 mg QD
12055280|NCT00151411|Drug|Metformin|Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).
12055281|NCT00151411|Drug|Placebo|Placebo
12055282|NCT00151411|Behavioral|Lifestyle Intervention|A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.
12055283|NCT00151398|Drug|lecozotan SR|"evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks.
~Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil."
12055284|NCT00151398|Drug|Donepezil|10 mg donepezil QD dosed up to 40 weeks
12055285|NCT00151385|Procedure|single blood draw|
12055286|NCT00151372|Behavioral|Treatment Adherence Intervention|The care management intervention aims at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability.
12055340|NCT00150982|Drug|Mechanism of action of alefacept|
12055341|NCT00150969|Dietary Supplement|vitamin K1 (phylloquinone)|
12055342|NCT00150969|Dietary Supplement|placebo|1 pill daily
12055343|NCT00150956|Procedure|Daily home hemodialysis|
12055344|NCT00150943|Device|Renal artery stent|
12055287|NCT00151372|Behavioral|Enhanced Care|For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients.
12055288|NCT00151359|Device|SoleSensor|
12055289|NCT00151346|Drug|Bupivacaine and Fentanyl (for CSE)|Bupivacaine 0.25% x 1 cc + Fentanyl 20 mcg, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr
12055290|NCT00151346|Drug|Bupivacaine and Fentanyl (for traditional epidural)|Bupivacaine 0.0625% with Fentanyl 2 mcg/mL x 15 cc, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr
12055291|NCT00151333|Drug|SRA-333|
12055292|NCT00151320|Drug|Bortezomib, CHOP, Rituximab|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
12055293|NCT00151307|Device|INVOS cerebral oximeter|
12055294|NCT00151294|Drug|escitalopram oxalate antidepressant|
12055295|NCT00151281|Drug|PEPC|"Induction phase (month 1-3)
~• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.
~Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.
~Post-Month 12 Maintenance phase (post-month 12 until disease progression)
~• PEPC QOD or fractionated weekly basis"
12055296|NCT00151281|Drug|Thalidomide|"Induction phase (month 1-3)
~• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.
~Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)
~Post-Month 12 Maintenance phase (post-month 12 until disease progression)
~• Daily low dose thalidomide (50-100mg/d)"
12055297|NCT00151281|Drug|Rituximab|"Induction phase (month 1-3)
~• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.
~Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.
~Post-Month 12 Maintenance phase (post-month 12 until disease progression)
~• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
12055298|NCT00151255|Drug|Cytarabine|100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)
12055299|NCT00151255|Drug|Idarubicin|12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
12055300|NCT00151255|Drug|All-trans retinoic acid|45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)
12055301|NCT00151255|Drug|Mitoxantrone|10mg/m² i.v. day 2-3 (first consolidation cycle)
12055302|NCT00151255|Drug|Etoposid|100mg/m² i.v. Tag 1-5 (second consolidation cycle)
12055303|NCT00151242|Drug|Cytarabine|100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
12055304|NCT00151242|Drug|Idarubicin|12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
12055305|NCT00151242|Drug|Etoposide|100mg/m² i.v. day 1-3 (induction therapy)
12055306|NCT00151242|Drug|All-trans retinoic acid|45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
12055307|NCT00151242|Drug|Pegfilgrastim|6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
12055308|NCT00151229|Other|target blood pressure|
12055309|NCT00151216|Biological|AAV2CUhCLN2 (3x10^12 particle units)|gene transfer; one-time administration via neuro surgery procedure
12055310|NCT00151203|Drug|Clarithromycin, Lenalidomide, Dexamethasone|"Dexamethasone (Decadron®) will be given orally at a dose of 40 mg on days 1, 2, 3, 8, 15 and 22 during the first cycle and once a week on days 1, 8, 15, and 22 for each subsequent cycle.
~Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day beginning on day 2 of cycle 1.
~Lenalidomide (Revlimid®) will be given orally at a dose of 25 mg daily beginning on day 3 and ending on day 21 of cycle 1 and on days 1-21 of subsequent cycles."
12055311|NCT00151190|Behavioral|Education for diabetes self-management|
12055312|NCT00151177|Device|non-invasive continuous positive airway pressure ventilation|
12055313|NCT00151177|Device|CPAP-treatment|night time CPAP-mask ventilation
12055314|NCT00151164|Procedure|donor bone marrow cell injection into thymus gland|
12055315|NCT00151151|Behavioral|Computer-Assisted Motivational Intervention|
12055316|NCT00151151|Behavioral|Didactic Educational Counseling|
12055317|NCT00151138|Drug|Atenolol (drug), Lisinopril (drug)|
12055318|NCT00151125|Drug|recombinant interleukin-11|25 mcg/kg subcutaneously daily for seven days
12055319|NCT00151125|Drug|recombinant interleukin-11|50 mcg/kg subcutaneously daily for 7 days
12055320|NCT00151125|Drug|recombinant interleukin-11|10 mcg/kg subcutaneously daily for 7 days
12055321|NCT00151112|Procedure|Positioning and plexus anesthesia|positioning during plexus anesthesia
12055322|NCT00151099|Drug|high caloric drink with protein|
12055323|NCT00151086|Drug|Estramustine|
12055324|NCT00151086|Drug|Vinorelbine|
12055325|NCT00151073|Drug|Zoledronic acid|
12055326|NCT00151073|Drug|Estramustine|
12055327|NCT00151073|Drug|Docetaxel|
12055328|NCT00151060|Drug|Estramustine|
12055329|NCT00151060|Drug|Etoposide|
12055330|NCT00151060|Drug|Paclitaxel|
12055331|NCT00151047|Drug|Capecitabine|
12055332|NCT00151047|Drug|Docetaxel|
12055333|NCT00151034|Drug|Trastuzumab|
12055334|NCT00151034|Drug|Paclitaxel|
12055335|NCT00151034|Drug|Carboplatin|
12055336|NCT00151034|Drug|Gemcitabine|
12055337|NCT00151021|Behavioral|Tailored web-based walking program|
12055338|NCT00151008|Drug|Bexarotene/NBUVB vs placebo NBUVB|
12055345|NCT00150930|Device|narrowband UVB phototherapy at home|
12055346|NCT00150917|Behavioral|Supportive-Expressive Group Therapy|
12055347|NCT00150904|Procedure|venous blood puncture|
12055348|NCT00150891|Procedure|Kidney transplantation|
12055349|NCT00150891|Drug|cyclosporine A|
12055350|NCT00150891|Drug|tacrolimus|
12055351|NCT00150891|Drug|azathioprine|
12055352|NCT00150891|Drug|mycophenolate mofetil|
12055353|NCT00150878|Other|Conditioning therapy|Preparation before allogeneic transplantation
12055354|NCT00150865|Drug|ropivacaine|
12055355|NCT00150852|Drug|Vancomycin|
12055356|NCT00150839|Drug|Mirtazapine|Patients receive mirtazapine 45mg and placebo.
12055357|NCT00150839|Drug|Venlafaxine|Patients receive mirtazapine 45mg and venlafaxine 300mg.
12055358|NCT00150826|Drug|Quinapril|Quinapril will be started at 40mg daily and titrated to 80mg daily for 16 weeks.
12055359|NCT00150826|Drug|Placebo|Placebo will be given in a capsule form once daily for 16 weeks.
12055360|NCT00150813|Drug|Levetiracetam|Pharmaceutical form: oral tablets Route of administration: Oral use
12055361|NCT00150800|Drug|Brivaracetam|"Active Substance: Brivaracetam
~Pharmaceutical Form: Tablet
~Concentration: 10 mg and 25 mg
~Route of Administration: Oral"
12055362|NCT00150787|Drug|LEVETIRACETAM|
12055363|NCT00150774|Drug|Levetiracetam|
12055364|NCT00150761|Drug|Levocetirizine (drug)|
12055365|NCT00150748|Drug|Levetiracetam 166 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Tablet
~Concentration: 166 mg
~Route of Administration: Oral use"
12055366|NCT00150748|Drug|Levetiracetam 250 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Tablet
~Concentration: 250 mg
~Route of Administration: Oral use"
12055367|NCT00150748|Drug|Levetiracetam 500 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Tablet
~Concentration: 500 mg
~Route of Administration: Oral use"
12055368|NCT00150735|Drug|LEVETIRACETAM|
12055369|NCT00150722|Drug|atorvastatin (or other tolerated statin + Niaspan/placebo)|atorvastatin 80 mg for all, randomized to 1500 mg niacin/placebo and then crossed over
12055370|NCT00150709|Drug|Levetiracetam (Keppra)|
12055371|NCT00150696|Drug|Risedronate|
12055372|NCT00150683|Device|vibration and passive standing versus passive standing alone|
12055373|NCT00150670|Drug|TS-1 and cisplatin|TS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle.
12055374|NCT00150670|Drug|TS-1|TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle.
12055375|NCT00150657|Drug|bevacizumab|
12055376|NCT00150657|Drug|carboplatin|
12055377|NCT00150657|Drug|gemcitabine|
12055378|NCT00150644|Drug|Asoprisnil|Asoprisnil 10mg Tablet, oral Daily for 12 weeks
12055379|NCT00150644|Drug|Asoprisnil|Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
12055380|NCT00150644|Drug|Placebo|Placebo Tablet, oral Daily for 12 weeks
12055381|NCT00150631|Drug|Candesartan|placebo controlled double blind
12055382|NCT00150618|Drug|SPD503 (1 mg)|
12055383|NCT00150618|Drug|SPD503 (2 mg)|
12055384|NCT00150618|Drug|SPD503 (3 mg)|
12055385|NCT00150618|Drug|SPD503 (4 mg)|
12055386|NCT00150618|Drug|Placebo|
12055387|NCT00150605|Drug|Extended-release carbamazepine|
12055388|NCT00150592|Drug|SPD503 (Guanfacine HCl)|
12055389|NCT00150592|Drug|Placebo|
12055390|NCT00150579|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate|
12055391|NCT00150566|Drug|Lanthanum carbonate|
12055392|NCT00150553|Drug|Extended-release carbamazepine|
12055393|NCT00150540|Drug|Lanthanum carbonate|
12055394|NCT00150527|Drug|Citalopram|40 mg, pill, single dose
12055395|NCT00150527|Drug|Escitalopram|20 mg, pill, single dose
12055396|NCT00150527|Drug|Dexamethasone|1 mg, pill, single dose
12055397|NCT00150527|Behavioral|Cold Pressor Test|single test
12055398|NCT00150514|Drug|Oralgen|
12055399|NCT00150514|Procedure|Nasal biopsy|
12055400|NCT00150514|Procedure|Nasal washing|
12055401|NCT00150514|Procedure|Peak nasal inspiratory flow|
12055402|NCT00150488|Device|Uracyst|2% weekly for 6 weeks, monthly for 4 months
12055403|NCT00150475|Procedure|Powered Air purifying respirator|
12055404|NCT00150462|Drug|Carfilzomib|Administered as an IV bolus dose
12055405|NCT00150462|Drug|Dexamethasone|Administered orally prior to carfilzomib
12055406|NCT00150449|Drug|Pregabalin|
12055407|NCT00150436|Drug|Pregabalin|
12055408|NCT00150423|Drug|Pregabalin|
12055409|NCT00150410|Drug|Inhaled insulin|
12055410|NCT00150397|Drug|Tofimilast|
12055411|NCT00150384|Drug|Amlodipine/Atorvastatin|
12055412|NCT00150371|Drug|atorvastatin|
12055413|NCT00150358|Drug|Sildenafil Citrate|
12055414|NCT00150345|Drug|voriconazole (Vfend)|voriconazole, early treatment
12055415|NCT00150345|Drug|voriconazole (Vfend)|voriconazole, deferred treatment
12055416|NCT00150332|Drug|linezolid|
12055417|NCT00150319|Drug|Vfend®; I.V.|
12055418|NCT00150306|Drug|Zoloft (Sertraline)|
12055419|NCT00150293|Drug|Pregabalin|
12055420|NCT00150280|Drug|celecoxib and ibuprofen SR|
12055421|NCT00150267|Drug|Xalacom|
12055422|NCT00150254|Drug|CP-526,555 (varenicline)|
12055423|NCT00150241|Drug|CP-526,555 (varenicline)|
12055424|NCT00150228|Drug|CP-526,555 (varenicline)|
12055425|NCT00150215|Drug|PF-00184562|
12055426|NCT00150215|Drug|Olanzapine|
12055427|NCT00150202|Drug|pegaptanib sodium|
12055428|NCT00150189|Behavioral|Sucrose|
12055429|NCT00150176|Drug|Asenapine - Open Label|Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
12055553|NCT00149110|Drug|duloxetine|60 mg daily
12055430|NCT00150176|Drug|Placebo - Double Blind|Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.
12055431|NCT00150176|Drug|Asenapine - Double Blind|Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.
12055432|NCT00150150|Procedure|Interstitial laser photocoagulation|
12055433|NCT00150137|Drug|Methimazole|
12055434|NCT00150124|Drug|MTZ+LT4|
12055435|NCT00150124|Drug|Methimazole|
12055436|NCT00150111|Drug|Methimazole|
12055437|NCT00150111|Drug|Rituximab|
12055438|NCT00150111|Biological|Immunization with various vaccines|
12055439|NCT00150098|Behavioral|Enhanced HIV risk reduction and HIV vaccine education|
12055440|NCT00150085|Drug|cyclosporine micro-emulsion|
12055441|NCT00150072|Drug|imatinib|
12055442|NCT00150059|Drug|Pimecrolimus Cream 1%|
12055443|NCT00150046|Drug|Everolimus|
12055444|NCT00150020|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|
12055445|NCT00150007|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12055446|NCT00149994|Drug|Cyclosporine A|
12055447|NCT00149994|Drug|Tacrolimus|
12055448|NCT00149994|Drug|Basiliximab|Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery.
12055449|NCT00149994|Drug|Methylprednisolone|Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery
12055450|NCT00149994|Drug|Prednisone|Post-operatively prednisone was tapered from an initial dose of 20mg/day to zero at 3 months or continued at 5-10mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
12055451|NCT00149981|Drug|everolimus (RAD)|Everolimus
12055452|NCT00149968|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg
12055453|NCT00149942|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
12055454|NCT00149929|Drug|Mycophenolate sodium (enteric coated)|
12055455|NCT00149916|Drug|Mycophenolate sodium (enteric coated)|
12055456|NCT00149903|Drug|Mycophenolate sodium (enteric coated)|
12055457|NCT00149890|Drug|Basiliximab|Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight <35 kg) or 20 mg (body weight ≥35 kg) strength.
12055458|NCT00149890|Drug|Cyclosporine/cyclosporine microemulsion|Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels.
12055459|NCT00149890|Drug|Steroid|Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6).
12055460|NCT00149877|Drug|Tegaserod|
12055461|NCT00149864|Drug|Mycophenolate sodium (enteric coated)|
12055462|NCT00149851|Drug|Tegaserod|
12055463|NCT00149838|Procedure|Prefrontal rTMS|Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
12055464|NCT00149838|Drug|Antidepressant Regimen|Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
12055465|NCT00149838|Procedure|Sham Stimulation|The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
12055466|NCT00149825|Drug|Escitalopram|5 to 20 mg for 12 weeks
12055467|NCT00149825|Behavioral|CBTI|Cognitive Behavioral Treatment for Insomnia
12055468|NCT00149825|Behavioral|CTRL|Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
12055469|NCT00149812|Behavioral|Family Functioning Intervention|
12055470|NCT00149799|Drug|Escitalopram|At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
12055471|NCT00149799|Drug|Placebo|At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
12055472|NCT00149786|Behavioral|Family Based Therapy|Family therapy will be given for a total of 24 hours over the course of 12 months.
12055473|NCT00149786|Behavioral|Ego-Oriented Individual Psychotherapy|Individual therapy will be given for a total of 24 hours over the course of 12 months.
12055474|NCT00149773|Behavioral|Cognitive Therapy|
12055475|NCT00149760|Behavioral|Augmented Standard Medical Care|Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
12055476|NCT00149760|Behavioral|Cognitive-Affective Behavior Therapy|Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
12055477|NCT00149747|Behavioral|Moderate-Intensity Aerobic Physical Activity|Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
12055478|NCT00149747|Behavioral|Health Education Class|2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
12055479|NCT00149734|Drug|Ondansetron followed by placebo|Participants will take 16mg of ondansetron daily for the first three months followed by 3 months of placebo. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
12055551|NCT00149110|Procedure|Diurnal rhythms|Keeping the day-night cycle constant by use of educational measures
12055552|NCT00149110|Behavioral|Exercise|Moderate intensity daily exercise for 30 minutes at least
12055480|NCT00149734|Drug|Placebo followed by Ondansetron|Participants will take placebo daily for the first three months followed by 3 months of 16mg of ondansetron daily. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
12055481|NCT00149721|Procedure|Ventriculo-peritonal shunting|
12055482|NCT00149708|Drug|growth hormone administration for 6 months|depot GH (Nutropin depot) 13.4 mg every 14 days
12055483|NCT00149695|Behavioral|Weekly home delivery of milk products|
12055484|NCT00149682|Behavioral|6-month educational program|
12055485|NCT00149682|Behavioral|6-month standard care program|
12055486|NCT00149669|Behavioral|employment-based reinforcement|Work Plus Naltrexone Contingency participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose.
12055487|NCT00149656|Dietary Supplement|Multivitamins|dietary supplement of multivitamins
12055488|NCT00149656|Dietary Supplement|Selenium|dietary supplement of selenium only
12055489|NCT00149656|Other|Placebo|placebo pill
12055490|NCT00149643|Drug|Fluoxetine|Gelatin capsules Fluoxetine 10 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20 mg, 2 capsules barring side effects.
12055491|NCT00149643|Other|Placebo|Gelatin capsules Placebo capsules, identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
12055492|NCT00149630|Drug|Disulfiram|Disulfiram 250 mg/day by mouth daily during study weeks 2-13. Disulfiram discontinued during study weeks 14-15.
12055493|NCT00149630|Drug|Methadone|Initial dose 25 mg; increased by 5 mg at each subsequent daily dosing until 60 mg maintenace dose reached.
12055494|NCT00149630|Behavioral|CBT|1-hour weekly, individual, manual-guided Cognitive Behaviorial Therapy.
12055495|NCT00149630|Other|Lactose|Lactose was added to both the active disulfiram and placebo doses so they tasted identical.
12055496|NCT00149617|Drug|Buspirone|
12055497|NCT00149604|Drug|conjugated estrogens|
12055498|NCT00149604|Drug|Raloxifene|
12055499|NCT00149604|Behavioral|exercise plus mild caloric restriction for weight loss|
12055500|NCT00149591|Procedure|coronary balloon-angioplasty with stenting|
12055501|NCT00149578|Drug|Gemcitabine Oxaliplatin 5FU and Leucovorin|
12055502|NCT00149565|Drug|IFN-α2b|
12055503|NCT00149552|Dietary Supplement|zinc|supplementation with zinc gluconate
12055504|NCT00149539|Drug|Buprenorphine/naloxone|
12055505|NCT00149526|Behavioral|Shared Decision-Making|
12055506|NCT00149513|Behavioral|Targeted Case Management|A nurse case manager will assess and follow intervention arm subjects for six months. Nurse case manager will help subjects acquire needed community health services.
12055507|NCT00149513|Behavioral|Usual care|Participants will receive usual care.
12055508|NCT00149500|Behavioral|Coaching|Patients received monthly calls to assist in behavioral change relative to asthma care
12055509|NCT00149487|Behavioral|Tailored Problem Solving Intervention|
12055510|NCT00149487|Behavioral|Family Education Intervention|
12055511|NCT00149474|Behavioral|Peak Flow Monitoring|
12055512|NCT00149461|Behavioral|Written Asthma Action Plan|
12055513|NCT00149448|Behavioral|TB Contact Priority Model|
12055514|NCT00149422|Device|NT-proBNP measurements|
12055515|NCT00149409|Dietary Supplement|Omacor|
12055516|NCT00149396|Drug|NV1020|NV1020 dose levels: 3x10^6, 1x10^7, 3x10^7, and 1x10^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks
12055517|NCT00149383|Drug|Rosiglitazone|
12055518|NCT00149383|Drug|Placebo|
12055519|NCT00149370|Procedure|Breast reduction surgery|
12055520|NCT00149357|Other|Thrombophilia Testing|TP testing in Group 1 and 3 only
12055521|NCT00149344|Radiation|Vertical scar versus inferior pedicle reduction mammoplasty|Vertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty
12055522|NCT00149331|Behavioral|Structured education program|
12055523|NCT00149318|Other|Biochemical analyses.|Biochemical analyses.
12055524|NCT00149305|Other|Genetic analyses|
12055525|NCT00149305|Other|Genetic analyses|
12055526|NCT00149292|Drug|LY2140023|
12055527|NCT00149292|Drug|olanzapine|
12055528|NCT00149292|Drug|placebo|
12055529|NCT00149279|Procedure|Surgery: D2 dissection|
12055530|NCT00149279|Procedure|Surgery: D2+paraaortic dissection|
12055531|NCT00149266|Procedure|Surgery: abdominal and transhiatal approach|
12055532|NCT00149266|Procedure|Surgery: left thoraco-abdominal approach|
12055533|NCT00149253|Drug|a single-dose of Etoricoxib before induction of anesthesia|
12055534|NCT00149240|Biological|Botulinum toxin type A|
12055535|NCT00149227|Drug|Valsartan|Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.
12055536|NCT00149227|Drug|Non-ARB|'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs
12055537|NCT00149214|Drug|pemetrexed|500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
12055538|NCT00149214|Drug|cyclophosphamide|600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
12055539|NCT00149214|Drug|doxorubicin|60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
12055540|NCT00149214|Drug|docetaxel|100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
12055541|NCT00149201|Drug|5-FU continuous infusion|
12055542|NCT00149201|Drug|MTX + 5-FU sequential therapy|
12055543|NCT00149188|Drug|Lanreotide (Autogel formulation)|
12055544|NCT00149175|Other|Blood sampling, skin biopsy|Blood sampling, skin biopsy in the field of the medical follow-up
12055545|NCT00149162|Drug|proleukin|"One cycle of treatment : D1 : 2.5 MUI/m2 (subcutaneous); D2 to D5 : 5 MUI / m2 (subcutaneous)
~1 cycle of treatment each month during 12 months"
12055546|NCT00149149|Drug|Zinc carnosine|
12055547|NCT00149136|Drug|imatinib|
12055548|NCT00149123|Drug|hydrocortisone 200 mg/day|
12055549|NCT00149110|Procedure|Sleep deprivation|3 days with a normal night between
12055550|NCT00149110|Procedure|Light therapy|Daily light therapy for 29 weeks
12055554|NCT00149110|Drug|duloxetine|60 mg daily
12055555|NCT00149084|Drug|Lansoprazole, clarithromycin, amoxicillin|
12055556|NCT00149071|Device|rTMS|15 treatments of rTMS active with a duration of 30 minutes each
12055557|NCT00149071|Device|TMS|Transcraniel Magnetic Stimulation active and sham
12055558|NCT00149071|Device|rTMS|active Transcranial Magnetic Stimulation
12055559|NCT00149071|Device|rTMS|daily for three weeks
12055560|NCT00149058|Drug|Erythropoietin|
12055561|NCT00149032|Procedure|DLI sensitized against antigens expressed by the host.|
12055562|NCT00149019|Drug|Cell therapy with bispecific antibodies|
12055563|NCT00149006|Procedure|Cell therapy|
12055564|NCT00148993|Biological|Tumor Cell Vaccine|
12055565|NCT00148980|Device|DBM for creation of bone marrow microenvironment|
12055566|NCT00148967|Device|Implantable Cardioverter Defibrillator|
12055567|NCT00148954|Device|VITALITY 2 Implantable Cardioverter Defibrillator|VITALITY 2 ICD
12055568|NCT00148954|Device|Medtronic Implantable Cardioverter Defibrillator|Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD
12055569|NCT00148941|Biological|SB213503 lot 1|SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
12055570|NCT00148941|Biological|SB213503 lot 2|SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
12055571|NCT00148941|Biological|SB213503 lot 3|SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
12055572|NCT00148941|Biological|Infanrix|Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
12055573|NCT00148941|Biological|IPOL|IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
12055574|NCT00148941|Biological|M-M-R II|M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
12055575|NCT00148928|Biological|P501-AS15 vaccine|
12055576|NCT00148915|Drug|ibandronate|
12055577|NCT00148915|Drug|Placebo|matching placebo
12055578|NCT00148902|Drug|lapatinib|lapatinib
12055579|NCT00148902|Drug|docetaxel|docetaxel
12055580|NCT00148889|Device|Deep brain stimulation (DBS)|Bilateral pallidal stimulation with an implanted DBS device
12055581|NCT00148876|Drug|Capecitabine|Capecitabine 2500 mg/m² orally day 1-14 q day 22
12055582|NCT00148876|Drug|Trastuzumab|Trastuzumab 6 mg/kg body weight every 3 weeks i.v.
12055583|NCT00148863|Drug|Peg-interferon alpha 2a (drug)|
12055584|NCT00148863|Drug|Ribavirin (drug)|
12055585|NCT00148863|Drug|Interferon gamma (drug)|
12055586|NCT00148850|Drug|Pioglitazone|
12055587|NCT00148837|Drug|Peg-interferon alpha 2b (drug)|
12055588|NCT00148837|Drug|Ribavirin (drug)|
12055589|NCT00148837|Drug|Prazosin (drug)|
12055590|NCT00148824|Biological|7-valent pneumococcal conjugate vaccine (vaccine)|
12055591|NCT00148824|Biological|23-valent pneumococcal conjugate vaccine (vaccine)|
12055592|NCT00148798|Drug|cetuximab + cisplatin + vinorelbine|cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
12055593|NCT00148798|Drug|cisplatin + vinorelbine|cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
12055594|NCT00148785|Drug|Indinavir/Ritonavir/Fosamprenavir|
12055595|NCT00148772|Drug|Erlotinib (Tarceva)|
12055596|NCT00148759|Drug|LPV/r|LPV/r 800/200 mg once daily
12055597|NCT00148746|Drug|Pimecrolimus|
12055598|NCT00148746|Drug|Tacrolimus|
12055599|NCT00148746|Drug|Prednisolone|
12055600|NCT00148746|Drug|Ciclosporin A|
12055601|NCT00148746|Drug|Dermatop|
12055602|NCT00148733|Drug|Zinc|Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
12055603|NCT00148720|Drug|Capecitabine|Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles
12055604|NCT00148707|Drug|CT-2103 (Xyotax)|
12055605|NCT00148694|Drug|Cisplatin|Intravenously once every three weeks for a total of 12 weeks
12055606|NCT00148681|Drug|Herceptin|Intravenously every week for 12 weeks (weeks 1-12) Intravenously every three weeks for 40 weeks (weeks 32-72)
12055607|NCT00148681|Drug|Navelbine|Intravenously every week for 12 weeks
12055608|NCT00148681|Drug|Doxorubicin|Every 3 weeks for 12 weeks
12055609|NCT00148681|Drug|Cyclophosphamide|Intravenously every 3 weeks for 12 weeks
12055610|NCT00148681|Drug|Paclitaxel|Weekly for 12 weeks (or a similar schedule)
12055611|NCT00148668|Drug|Herceptin|One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
12055612|NCT00148668|Drug|Navelbine|Weekly injections given starting week 3 and ending week 14
12055613|NCT00148668|Drug|Taxotere|Given every three weeks starting week 3 and ending on week 14
12055614|NCT00148668|Drug|Carboplatin|Given every three weeks starting week 3 and ending on week 14
12055615|NCT00148655|Device|Decision Board|Decision board that explains the risks and benefits of treatment options
12055616|NCT00148642|Device|silver salts coated endotracheal tube|intubation with silver coated tube
12055617|NCT00148642|Device|uncoated endotracheal tube|intubation
12055618|NCT00148629|Drug|multivitamin, mebendazole|
12055619|NCT00148616|Drug|Memantine|Daily dosage of 20 mg Memantine add-on to Risperidone vs. Placebo add-on to Risperidone
12055620|NCT00148616|Drug|Placebos|Daily dosage of 20 mg Placebo add-on to Risperidone vs. Memantine add-on to Risperidone
12055621|NCT00148603|Drug|montelukast|
12055622|NCT00148590|Drug|Memantine|Daily dose of 20 mg Memantine add-on to Risperidone vs Placebo add-on to Risperidone
12055623|NCT00148590|Drug|Placebo|Daily dose of 20 mg Memantine add-on to Risperidone vs Placebo add-on to Risperidone
12055624|NCT00148577|Device|Transcutaneous Electrical Nerve Stimulation|
12055625|NCT00148564|Drug|olanzapine|treatment with either Olanzapine or Ziprasidone
12055626|NCT00148564|Drug|Ziprasidone|treatment with either Olanzapine or Ziprasidone
12055627|NCT00148551|Drug|Triamcinolone Acetonide|
12055628|NCT00148538|Behavioral|Resistance and/or Aerobic Exercise|Resistance and/or Aerobic Exercise
12055629|NCT00148525|Behavioral|Social Cognitive Theory|6 mo dietary intervention. This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory.
12055630|NCT00148525|Behavioral|goal system theory|This arm received a 6 mo diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory and delivered by an automated telephone system.
12055631|NCT00148512|Drug|1. Tesofensine (NS 2330)|
12055632|NCT00148499|Drug|Ambroxol hydrochloride (Mucoangin?)|
12055633|NCT00148499|Drug|benzocaine|
12055634|NCT00148486|Drug|NS 2330|
12055635|NCT00148473|Drug|Misoprostol|
12055636|NCT00148460|Drug|TNK-tPA|
12055637|NCT00148460|Drug|rt-PA|
12055638|NCT00148447|Drug|escitalopram|
12055639|NCT00148434|Behavioral|Patient-held guideline for hypertension|
12055640|NCT00148421|Drug|Darbepoetin alfa and Epoetin alfa|
12055641|NCT00148408|Drug|Montelukast|
12055642|NCT00148408|Behavioral|Education|
12055643|NCT00148395|Drug|Gemcitabine|
12055644|NCT00148395|Drug|Navelbine|
12055645|NCT00148395|Drug|Carboplatin|
12055646|NCT00148395|Drug|Cisplatin|
12055647|NCT00148395|Drug|Mitomycin|
12055648|NCT00148395|Drug|Ifosfamide|
12055649|NCT00148382|Drug|ATL-962|
12055650|NCT00148369|Drug|Safety observation|Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.
12055651|NCT00148356|Device|ZoMaxx™ Drug-Eluting Coronary Stent System|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12055652|NCT00148356|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12055653|NCT00148343|Device|Odstock Dropped-Foot Stimulator (ODFS)|Device implementation & use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
12055654|NCT00148343|Other|Conventional Standard of Care|Conventional standard of care (which may include implementation & use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.
12055655|NCT00148343|Procedure|Traditional Physical Therapy Treatment|Traditional physical therapy treatment for 12 weeks.
12055656|NCT00148330|Drug|Triamcinolone acetate|When indicated, intravitreal triamcinolone (0.1 ml of Kenacort 40© [40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia]) was injected into the vitreous under sterile conditions in a minor procedures area.
12055657|NCT00148317|Drug|Bortezomib|During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11
12055658|NCT00148317|Drug|dexamethasone|During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18
12055659|NCT00148317|Drug|liposomal doxorubicin|If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cycles
12055660|NCT00148317|Drug|cyclophoshamide|During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8
12055661|NCT00148317|Drug|filgrastim|During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9
12055662|NCT00148291|Drug|Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.|
12055663|NCT00148278|Drug|norepinephrine and dobutamine|continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 70mmHg or more and dobutamine could be added as a continuous infusion when cardiac index was of less than 2.5 liters per squared meter of body surface
12055664|NCT00148278|Drug|epinephrine plus placebo of dobutamine|epinephrine was titrated to maintain a mean arterial pressure at 70mmHg or more and placebo of dobutamine was titrated in case of a cardiac index lower than 2.5 liters per squared meters of body surface
12055665|NCT00148265|Drug|Triamcinolone acetate|Eyes assigned to IVTA received an intravitreal injection of 0.1 ml of Kenacort 40© [40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia] on the day of the baseline visual acuity measurement under sterile conditions in a minor procedures area as an outpatient procedure. Eyes assigned to placebo were prepared in the same way but had the barrel of the syringe without a needle pushed firmly against the eye to simulate an injection.
12055666|NCT00148252|Drug|Mycophenolate mofetil withdrawal|
12055667|NCT00148252|Drug|Cyclosporione A withdrawal|
12055668|NCT00148239|Behavioral|Caregiver Only Intervention|A multi-component psycho-educational intervention designed to reduce the negative emotional and behavioral responses of the caregiver and reduce the risk of mental and physical health problems.
12055669|NCT00148239|Behavioral|Dual Treatment|Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
12055670|NCT00148239|Behavioral|Control|Participants given written educational materials at beginning of study; no treatment beyond this
12055671|NCT00148226|Behavioral|Decision Aid|
12055672|NCT00148174|Behavioral|Intensive telephone followup|Telephone calling
12055673|NCT00148148|Drug|caspofungin|
12055674|NCT00148148|Drug|liposomal amphotericin B|
12055675|NCT00148135|Drug|Carboplatin|
12055676|NCT00148135|Drug|Gemcitabine|
12055677|NCT00148135|Drug|Capecitabine|
12055732|NCT00147771|Drug|Imiquimod 5% cream|Treatment will last for 36 weeks. Patients will be instructed to apply Imiquimod three times per week for 4 weeks. If no local side effects are noted at the 4 week- follow-up visit, the frequency of the application will be increased to 5 weekly applications.
12055733|NCT00147758|Drug|Colesevelam hydrochloride|
12055678|NCT00148122|Drug|Docetaxel|Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.
12055679|NCT00148122|Drug|Capecitabine|Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.
12055680|NCT00148109|Drug|Cetuximab|The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes.
12055681|NCT00148109|Drug|Cetuximab|Cetuximab 400 mg/m2 over 120 min IV initial does followed by weekly Cetuximab 250 mg/m2 over 60 min
12055682|NCT00148096|Device|Mechanical Heat Recovery Ventilation|De-humidification without loss of heat
12055683|NCT00148083|Drug|Risperdal Consta (drug)|
12055684|NCT00148083|Behavioral|Social Skills Training|
12055685|NCT00148070|Drug|Docetaxel|You will then receive your first dose of docetaxel chemotherapy. It is put through your IV over 1-2 hours. you will receive docetaxel every 3 weeks in the Cancer Center Infusion area.
12055686|NCT00148070|Procedure|Erythromycin Breath Test (ERMBT)|you will have an erythromycin breath test, which is an experimental test which is used to estimate the amount of enzyme produced by your liver which can metabolize the chemotherapy, docetaxel. For this test, you go to the GCRC where you will receive an injection of erythromycin (an antibiotic) which is labeled with a very small amount of radioactive substance. 20 minutes later you will blow air from your mouth into a blue solution until it clears. Your doctors will calculate the dose of docetaxel to be given to you based on this blood test, on your body's albumin level (a protein determined on the blood test), and on your height and weight.
12055687|NCT00148057|Behavioral|Low-fat diet|
12055688|NCT00148044|Procedure|Blood sampling for determination of uremic toxins|
12055689|NCT00148031|Drug|Pegylated Interferon and Ribavirin|Both groups with receive the same medical intervention but offered at different locations
12055690|NCT00148031|Behavioral|Psychosocial|Assessment of the likelihood of HCV treatment initiation and completion
12055691|NCT00148031|Behavioral|On-site (MMT Clinic) HCV evaluation and treatment|Standard HCV treatment with Pegylated Interferon and Ribavirin
12055692|NCT00148031|Behavioral|Off-site HCV evaluation and treatment|Standard HCV treatment with Pegylated Interferon and Ribavirin
12055693|NCT00148018|Drug|Bortezomib|
12055694|NCT00148018|Drug|Dexamethasone|
12055695|NCT00148005|Procedure|Questionnaire and micturition and drinking diaries|
12055696|NCT00148005|Procedure|Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)|
12055697|NCT00148005|Behavioral|Adaptation of the drinking scheme|
12055698|NCT00148005|Drug|Anticholinergic therapy|
12055699|NCT00148005|Behavioral|Micturition clock|
12055700|NCT00147992|Procedure|Immediate loading of implants in totally edentate upper and lower jaw|Immediate loading of implants in totally edentate upper and lower jaw.
12055701|NCT00147979|Device|Bridging by PTFE with bounded heparin|Bridging by PTFE with bounded heparin
12055702|NCT00147979|Device|Bridging by PTFE without bounded heparin|Bridging by PTFE without bounded heparin
12055703|NCT00147966|Drug|rituximab|treatment with rituximab
12055704|NCT00147953|Drug|Rituximab|
12055705|NCT00147953|Procedure|Total nodal irradiation|
12055706|NCT00147940|Procedure|Acoustic rhinometry (procedure)|
12055707|NCT00147927|Behavioral|Sequential emails and web support|
12055708|NCT00147914|Drug|Cefdinir (drug)|cefdinir 300mg per orally twice daily for 10 days
12055709|NCT00147914|Drug|amoxicillin/clavulanate|1000mg /62.5mg extended release per orally twice daily for 10 days
12055710|NCT00147901|Drug|FCCam|After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
12055711|NCT00147888|Procedure|Acoustic rhinometry (procedure)|Acoustic rhinometry is a procedure that uses sound waves to measure the cross-sectional area and volume of the nasal cavity.
12055712|NCT00147875|Drug|Prednisone|
12055713|NCT00147875|Drug|Vinblastine|
12055714|NCT00147875|Drug|Doxorubicin (Adriamycin)|
12055715|NCT00147875|Drug|Gemcitabine|
12055716|NCT00147862|Drug|Tranexamic Acid|
12055717|NCT00147849|Behavioral|mailing of printed educational materials|
12055718|NCT00147849|Behavioral|a combination of interactive educational meetings, educational outreach visits, and reminders|
12055719|NCT00147849|Behavioral|identification of local opinion leaders and establishment of local consensus processes|
12055720|NCT00147836|Drug|Human Insulin (Novolin-R, Novo Nordisk)|
12055721|NCT00147836|Device|H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland|
12055722|NCT00147836|Other|Pre-meal|
12055723|NCT00147836|Drug|Novolin-R|
12055724|NCT00147836|Drug|Human Insulin NPH (Novolin-N, Novo Nordisk)|
12055725|NCT00147836|Drug|Gliclazide (Diamicron, Servier)|
12055726|NCT00147836|Drug|Diamicron and Glucophage|
12055727|NCT00147823|Device|Vitoss Alone|Synthetic bone graft material
12055728|NCT00147823|Device|Vitoss with Bone Marrow Aspirate|Vitoss mixed with Bone Marrow aspirate
12055729|NCT00147810|Procedure|Telephone outreach to enhance asthma care|
12055730|NCT00147784|Drug|Ribavirin|800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks
12055731|NCT00147784|Drug|Pegylated Interferon|180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks
12055734|NCT00147745|Drug|Colesevelam|Colesevelam 3.8g for 12 weeks
12055735|NCT00147745|Drug|Colesevelam matching placebo|Colesevelam matching placebo for 12 weeks
12055736|NCT00147745|Drug|Insulin glargine (Lantus)|Insulin glargine for 12 weeks
12055737|NCT00147732|Radiation|Accelerated radiotherapy|68 Gy over 5.5 weeks
12055738|NCT00147732|Radiation|ARCON|68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily
12055739|NCT00147719|Drug|Colesevelam hydrochloride|
12055740|NCT00147706|Procedure|Tailored Healthmedia programs on EHR Patient Portal|
12055741|NCT00147693|Behavioral|Diagnosis of caregivers' problems|
12055742|NCT00147693|Behavioral|Professional service: treatment of problems by counseling or practical support|
12055743|NCT00147680|Drug|Paclitaxel, Carboplatin|
12055744|NCT00147667|Drug|Erythromycin|
12055745|NCT00147654|Drug|Tolterodine ER 4 mg QD|
12055746|NCT00147654|Drug|Tamsulosin 0.4 mg QD|
12055747|NCT00147628|Drug|sildenafil citrate|
12055748|NCT00147628|Drug|placebo for sildenafil citrate|
12055749|NCT00147615|Drug|Eplerenone|
12055750|NCT00147602|Drug|atorvastatin|
12055751|NCT00147589|Drug|Eplerenone|
12055752|NCT00147576|Drug|CP-866,087|
12055753|NCT00147563|Drug|Eplerenone|
12055754|NCT00147550|Drug|PD-0325901|Administered orally either once or twice a day; several dosing schedules evaluated; current dosing schedule is 5 days on-drug, 2-days off drug for 3 weeks in a 28-day cycle. Doses evaluated ranged from 1 mg once a day to 30 mg twice daily.
12055755|NCT00147537|Drug|CP-751,871|"Phase 2 Arm A:
~CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles"
12055756|NCT00147537|Drug|paclitaxel|"Phase 2 Arm A:
~Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles
~Phase 2 Arm B:
~Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles"
12055757|NCT00147537|Drug|carboplatin|"Phase 2 Arm A:
~Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles
~Phase 2 Arm B:
~Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles"
12055758|NCT00147537|Drug|CP-751,871|Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)
12055759|NCT00147537|Drug|paclitaxel|Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)
12055760|NCT00147537|Drug|carboplatin|Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)
12055761|NCT00147537|Drug|erlotinib|Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)
12055762|NCT00147524|Drug|quinapril|
12055763|NCT00147524|Procedure|Laser Doppler imaging|
12055764|NCT00147511|Drug|linezolid|
12055765|NCT00147498|Drug|CP-690,550|Oral tablets administered at a dose of 5 mg BID for 6 weeks
12055766|NCT00147498|Drug|CP-690,550|Oral tablets administered at a dose of 15 mg BID for 6 weeks
12055767|NCT00147498|Drug|CP-690,550|30 mg BID for 6 weeks
12055768|NCT00147498|Other|Placebo|Placebo tablets
12055769|NCT00147485|Drug|AG-024322|
12055770|NCT00147472|Other|PET scan in addition to conventional CT imaging|PET scans, Pre and post radiation treatment
12055771|NCT00147459|Biological|HBV vaccine booster|
12055772|NCT00147446|Behavioral|Individual Stress Management|Stress management therapy for multiple sclerosis (SMT-MS) is a manualized, validated, published stress management program designed for patients with MS. Participants met with a therapist for 16 individual 50-minute sessions conducted over 20-24 weeks. The first 6 sessions focused on teaching problem solving skills, relaxation, increasing positive activities, cognitive restructuring, and enhancement of social support. Participants were able to tailor the treatment to meet their needs using optional treatment modules including communication and assertiveness training, fatigue management, anxiety reduction, pain management, management of cognitive problems, insomnia treatment, and management of sexual dysfunction.
12055773|NCT00147446|Other|Wait List Control|Wait List Control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluation that were not contaminated by the workshop.
12055774|NCT00147420|Drug|Zhi Byed 11|
12055775|NCT00147394|Drug|Risperidone|
12055776|NCT00147381|Drug|Alemtuzumab|"Day 0: Campath-1H 20 mg IV infusion over 3-6 hours
~Day 1: Campath-1H 20 mg IV infusion over 3-6 hours"
12055777|NCT00147381|Drug|Tacrolimus|"Day 0: Tacrolimus will be given pre-operatively or immediately post transplant surgery. The recommended initial daily starting dose is 0,1 mg/kg/d orally (0,05 mg/kg/bid) to aim at a whole blood level of 8-12 ng/ml.
~till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months).
~Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months."
12055778|NCT00147381|Drug|Alemtuzumab|"Day 0: Campath-1H 30 mg IV infusion over 3-6 hours
~Day 1: Campath-1H 30 mg IV infusion over 3-6 hours"
12055779|NCT00147368|Drug|intravenous (IV) arginine|
12055780|NCT00147355|Drug|ondansetron, ibuprofen, paracetamol|ondansetron 4mg bid + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
12055781|NCT00147355|Drug|Ondansetron, ibuprofen, paracetamol|Ondansetron 4mg bid + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
12055782|NCT00147355|Drug|metoclopramide, ibuprofen, paracetamol|metoclopramide 10mg qds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
12055783|NCT00147355|Drug|Metoclopramide, codeine phosphate, ibuprofen, paracetamol|metoclopramide 10mg qds + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
12055784|NCT00147329|Drug|MM-093|
12055785|NCT00147316|Drug|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
12055786|NCT00147303|Drug|MCI-9042|
12055787|NCT00147290|Device|Implantable Cardiac Defibrillator|Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
12055919|NCT00146146|Drug|testosterone undecanoate plus letrozole|TU 1000 mg/12 weeks Letrozole 2.5 mg/day
12055925|NCT00146120|Drug|All-trans Retinoid acid|
12055788|NCT00147277|Device|Implantable Cardiac Defibrillator|Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
12055789|NCT00147264|Drug|Telmisartan (Micardis®) vs. Placebo|
12055790|NCT00147264|Behavioral|Low-Glycemic Index Diet vs. Control Diet|
12055791|NCT00147251|Drug|FDA approved drugs to treat blood pressure and cholesterol|
12055792|NCT00147238|Drug|Ferumoxtran-10 (USPIO)|Intravenous infusion of 2.6 mg/kg of ferumoxtran-10
12055793|NCT00147238|Procedure|MR lymphangiography|First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.
12055794|NCT00147225|Drug|AMG 531|"Beginning with Cycle 2, administered in one of two schedules, either on day after chemotherapy and 2 days later (study cycle) or on day -5 (pre dose) and on day after chemotherapy (post dose) or combination of pre/post days of 21-28 day treatment cycle. Combination if Optimal biological dose (OBD) not reached, additional treatment at 10 mcg/kg dose level, with AMG 531 administered on day -5 (pre dose) and on day after chemotherapy (post dose).
~1, 3, or 10 mcg/kg given as injection under the skin (subcutaneous)"
12055795|NCT00147225|Drug|Carboplatin|AUC=11; Cycle 1 chemotherapy alone then 3 weeks later, in Cycle 2, same dose of chemotherapy followed by AMG 531.
12055796|NCT00147225|Drug|Adriamycin|75-90 mg/m^2 IV
12055797|NCT00147225|Drug|Ifosfamide|10 gm/m^2 IV; OR, High dose ifosfamide = 14 gm/m^2.
12055798|NCT00147212|Drug|ET 743|ET-743 administered IV by 24-hr infusion every 3 weeks
12055799|NCT00147199|Drug|Inhaled treprostinil|Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.
12055800|NCT00147199|Drug|Placebo inhalation solution|Doses are titrated to 9 breaths four times daily.
12055801|NCT00147186|Device|Hylan G-F 20|
12055802|NCT00147160|Drug|Temozolomide, Cisplatinum|
12055803|NCT00147147|Procedure|Gastrectomy with D2 or greater lymph node dissection|
12055804|NCT00147147|Drug|Gastrectomy+ chemotherapy|
12055805|NCT00147134|Procedure|open colectomy|Procedure/Surgery: open colectomy
12055806|NCT00147134|Procedure|laparoscopic colectomy|Procedure/Surgery: laparoscopic colectomy
12055807|NCT00147121|Drug|Rituximab + Standard CHOP|Rituximab + Standard CHOP
12055808|NCT00147121|Drug|Rituximab + Bi-weekly CHOP|Rituximab + Bi-weekly CHOP
12055809|NCT00147108|Device|ExAblate 2000|
12055810|NCT00147056|Device|ExAblate transcranial system|MRI-Guided Focused Ultrasound Feasibility Study for Brain
12055811|NCT00147043|Procedure|Leukapheresis|
12055812|NCT00147043|Procedure|Infusion of stem cells via image guided scan|
12055813|NCT00147030|Procedure|Whole body mild induced hypothermia|Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia
12055814|NCT00147004|Drug|hydrocortisone sodium succinate|50 mg intravenous bolus every six hours for 5 days, then tapered to 50 mg intravenously every 12 hours for days 6-8, 50 mg every 24 hours for days 9-11 and then stopped
12055815|NCT00147004|Drug|Placebo|
12055816|NCT00146978|Procedure|intra-arterial treatment|
12055817|NCT00146952|Device|Vibrotactile feedback|
12055818|NCT00146926|Drug|kétamine 20mg|
12055819|NCT00146926|Drug|ephedrine 3mg|
12055820|NCT00146926|Drug|lidocaine 40mg|
12055821|NCT00146913|Drug|Imatinib mesylate 600mg/day|
12055822|NCT00146913|Drug|Peg-Interféron at 90 microg/week|
12055823|NCT00146900|Procedure|Cognitive Behavioral Therapy|12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
12055824|NCT00146900|Procedure|Cognitive Therapy|12 weekly 1.5 hours weekly session of cognitive therapy without exposure
12055825|NCT00146900|Drug|Escitalopram|Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
12055826|NCT00146900|Other|Placebo|Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
12055827|NCT00146887|Procedure|coronary catheterization|
12055828|NCT00146874|Device|cardiac resynchronization therapy|
12055829|NCT00146861|Device|sensor programming|
12055830|NCT00146848|Device|Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices|"All subjects in this trial receive the same device. For the purpose of this trial, intervention is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm."
12055831|NCT00146835|Biological|Pediarix|1 or more injections
12055832|NCT00146835|Biological|Licensed DTPa containing vaccine|1 or more injections
12055833|NCT00146835|Biological|Prevnar®: (Wyeth)|Concomitant vaccination
12055834|NCT00146822|Device|ENDOTAK RELIANCE G lead|
12055835|NCT00146809|Drug|Minocyline|
12055836|NCT00146796|Device|Rapid diagnostic test for malaria|
12055837|NCT00146783|Drug|Sulphadoxine-pyrimethamine|
12055838|NCT00146783|Drug|Sulphadoxine-pyrimethamine, amodiaquine|
12055839|NCT00146770|Biological|Aldurazyme|Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks
12055840|NCT00146770|Biological|Aldurazyme|0.58 mg/kg Aldurazyme every week for 208 weeks
12055841|NCT00146770|Biological|placebo|Placebo for 26 weeks
12055842|NCT00146757|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|100 U/kg every week
12055843|NCT00146757|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|200 U/kg every week (Week 26 onwards)
12055844|NCT00146744|Biological|Mtb72F/AS02A|
12055845|NCT00146731|Drug|SP|
12055846|NCT00146731|Drug|SP + amodiaquine|
12055847|NCT00146731|Drug|AQ + artesunate|
12055848|NCT00146731|Drug|chlorproguanil-dapsone|
12055849|NCT00146718|Drug|Amodiaquine and Sulphadoxine/Pyrimethamine|
12055850|NCT00146705|Procedure|blood samples are taken once|
12055851|NCT00146692|Behavioral|Free medical treatment|
12055920|NCT00146146|Drug|testosterone undecanoate plus dutasteride|TU 1000 mg/12weeks Dutasteride 0.5 mg/day
12055921|NCT00146133|Behavioral|diet, exercise|
12055852|NCT00146679|Behavioral|Psychoeducational Telephone counseling (TC)|Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
12055853|NCT00146679|Behavioral|Psychoeducational Intervention by Group (SG)|Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
12055854|NCT00146679|Behavioral|Usual Care|Usual Care provided by providers
12055855|NCT00146666|Device|Intermittent compression|
12055856|NCT00146640|Drug|MR Prednisone|Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams [mg] prednisone per day) at bed time.
12055857|NCT00146640|Drug|IR Prednisone|Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
12055858|NCT00146640|Drug|Placebo - MR Prednisone|Participants will receive placebo matching to MR prednisone tablet at bed time.
12055859|NCT00146640|Drug|Placebo - IR Prednisone|Participants will receive placebo matching to IR prednisone tablet in the morning.
12055860|NCT00146627|Drug|Eflornithine|
12055861|NCT00146627|Drug|Nifurtimox|
12055862|NCT00146614|Drug|Sirolimus|
12055863|NCT00146614|Drug|Tacrolimus|
12055864|NCT00146614|Drug|Methotrexate|
12055865|NCT00146614|Procedure|Stem Cell Transplantation|
12055866|NCT00146601|Drug|Fulvestrant|
12055867|NCT00146588|Drug|Cyclophosphamide|Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
12055868|NCT00146588|Drug|Epirubicin|Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
12055869|NCT00146588|Drug|Capecitabine|Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.
12055870|NCT00146575|Device|Sirolimus-eluting stent (Cypher)|patients have been implanted a Cypher stent
12055871|NCT00146575|Device|Paclitaxel-eluting stent (Taxus)|patients have been implanted a Taxus stent
12055872|NCT00146562|Drug|Darbepoetin Alfa|Given day before chemotherapy of red blood cell count is below normal
12055873|NCT00146562|Drug|Pegfilgrastim|Given as an injection the day before chemotherapy for a total of 8 injections
12055874|NCT00146562|Drug|Paclitaxel|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
12055875|NCT00146562|Drug|Doxorubicin|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
12055876|NCT00146562|Drug|Cyclophosphamide|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
12055877|NCT00146549|Drug|Trastuzumab|
12055878|NCT00146549|Drug|Vinorelbine|
12055879|NCT00146549|Drug|Paclitaxel|
12055880|NCT00146549|Drug|Docetaxel|
12055881|NCT00146523|Drug|Mifepristone|
12055882|NCT00146523|Drug|placebo|
12055883|NCT00146510|Behavioral|HealtheLifestyle Program|
12055884|NCT00146510|Behavioral|step counters with monthly feedback on logs|
12055885|NCT00146497|Drug|Budesonide-Surfactant|
12055886|NCT00146484|Drug|Twice Daily versus Three Times Daily Insulin Injections|
12055887|NCT00146471|Drug|Levetiracetam|1500-2000 mg daily add-on or Placebo Diazepam as needed
12055888|NCT00146471|Drug|Placebo|1500-2000 mg daily add-on or Placebo Diazepam as needed
12055889|NCT00146458|Procedure|18F-fluorodeoxyglucose positron emission tomography|
12055890|NCT00146445|Behavioral|Peer Mentoring Intervention|
12055891|NCT00146432|Procedure|Immunoadsorption of LPS, IL-6 and C5a|
12055892|NCT00146419|Behavioral|Reduction in behaviors capable of sexually transmitting HIV|Clinic-level risk reduction counseling
12055893|NCT00146406|Behavioral|Project Connect|
12055894|NCT00146393|Behavioral|People with Arthritis Can Exercise program|
12055895|NCT00146380|Drug|Zidovudine/Lamivudine and either Nevirapine or Nelfinavir|"Zidovudine 300mg po bid from 34 weeks gestation to 6 months postpartum Lamivudine 150mg po bid from 34 weeks gestation to 6 months postpartum AND EITHER Nevirapine 200mg po qd for 2 weeks as lead in then bid from 34 weeks gestation to 6 months postpartum OR Nelfinavir 1250mg po bid from 34 weeks gestation to 6 months postpartum
~ARVs continued for those that meet WHO treatment criteria"
12055896|NCT00146380|Behavioral|Breastfeeding for 6 months postpartum|Exclusive breastfeeding till five and one half months with rapid weaning over 2 weeks and cessation of breastfeeding at 6 months when ARVs are discontinued
12055897|NCT00146367|Behavioral|Active Living Every Day|
12055898|NCT00146354|Behavioral|Hospitalists Results Manager|
12055899|NCT00146341|Drug|Telmisartan/HCTZ|
12055900|NCT00146341|Drug|Telmisartan|
12055901|NCT00146328|Drug|Tipranavir|
12055902|NCT00146315|Behavioral|Supervised exercise on a stationary bicycle, 3-5 days a week|Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease
12055903|NCT00146315|Behavioral|Secondary prevention program for coronary heart disease|Secondary prevention program for coronary heart disease
12055904|NCT00146302|Biological|Bacille Calmette Guerin (BCG)|
12055905|NCT00146289|Drug|MICARDIS® (telmisartan)|
12055906|NCT00146276|Drug|gemcitabine|
12055907|NCT00146263|Behavioral|Savyon|Computerized cognitive training
12055908|NCT00146263|Behavioral|Control|Usual activity
12055909|NCT00146250|Drug|Nitrous oxide|Substitution of Nitrous oxide for Nitrogen as balance gas in inspired gas mixture
12055910|NCT00146237|Drug|phenytoin|
12055911|NCT00146224|Drug|Epoetin alfa RB|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
12055912|NCT00146224|Drug|Epoetin alfa DT|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
12055913|NCT00146211|Drug|Ethyl-EPA (Miraxion™)|
12055914|NCT00146198|Drug|ALGRX 4975|
12055915|NCT00146185|Drug|ALGRX 3268|
12055916|NCT00146172|Drug|neratinib|HKI-272
12055917|NCT00146159|Drug|Mitoxantrone|dosage
12055918|NCT00146146|Drug|testosterone undecanoate alone|1000 mg/12 weeks
12055926|NCT00146107|Behavioral|Diet|10 percent weight loss through diet and behavioral modification
12055927|NCT00146107|Other|Exercise|Multicomponent (resistance, aerobic, balance) exercise three times a week
12055928|NCT00146107|Other|Weight Loss and Exercise|10% weight loss through diet and exercise plus multicomponent exercise training three times a week
12055929|NCT00146094|Procedure|BMD Measurement|
12055930|NCT00146081|Behavioral|Weight Management|Participants (Index Participants) who identify 1 or 2 family members or friends (Co-Participants) to enroll with them are randomly assigned into either program A or B, and those who choose to enroll by themselves are randomly assigned to either program C or D. All Index Participants are invited to attend weekly group behavior change educational sessions; weekly in first 6 months, biweekly in next 6 months, and monthly in year 2. Co-Participants in program A are invited to attend all sessions with their Index Participant, but only the field workshops and personal counseling sessions if enrolled in program B.
12055931|NCT00146068|Drug|Avonex/Zocor|
12055932|NCT00146055|Procedure|Reduced intensity conditioning with allogeneic transplant|
12055933|NCT00146042|Drug|Docetaxel|
12055934|NCT00146042|Drug|Trastuzumab|
12055935|NCT00146042|Procedure|Erythromycin Breath Test (ERMBT)|
12055936|NCT00146016|Drug|Amantadine|
12055937|NCT00146003|Drug|Efalizumab treatment|
12055938|NCT00145990|Drug|methacholine|
12055939|NCT00145990|Device|KoKo Digidoser|
12055940|NCT00145990|Device|Rosethal Dosimeter|
12055941|NCT00145977|Drug|Alendronate|alendronate 70 mg once weekly
12055942|NCT00145977|Dietary Supplement|Calcium Citrate|600 mg of calcium citrate
12055943|NCT00145977|Dietary Supplement|Vitamin D|500 mg of Vitamin D consumed with the evening meal.
12055944|NCT00145951|Behavioral|motivational interviewing, brief advice in primary care|motivational interviewing, brief advice in primary care
12055945|NCT00145938|Drug|sildenafil|
12055946|NCT00145925|Drug|Perindopril-indapamide|
12055947|NCT00145925|Drug|Gliclazide MR-based glucose lowering|
12055948|NCT00145912|Behavioral|MI + CATCH-IT Internet Site|MI + CATCH-IT Internet Site
12055949|NCT00145912|Behavioral|BA (brief advice) + CATCH-IT Internet site|BA (brief advice) + CATCH-IT Internet site
12055950|NCT00145886|Drug|rhPTH|Subjects will be treated with rhPTH for 12 months.
12055951|NCT00145873|Drug|nesiritide, continuous infusion|
12055952|NCT00145847|Drug|Naltrexone or Placebo|Naltrexone or Placebo 50 mg per day
12055953|NCT00145834|Behavioral|community based trial|
12055954|NCT00145808|Device|Given® Diagnostic System|
12055955|NCT00145795|Drug|Kaletra + Current Dual NRTI Backbone|
12055956|NCT00145795|Drug|Current Regimen|
12055957|NCT00145782|Behavioral|Life style|
12055958|NCT00145769|Drug|Short Course Adjuvent Chemotherapy|Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
12055959|NCT00145769|Drug|Long Course Adjuvant Chemotherapy|Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
12055960|NCT00145769|Radiation|Short Course Radiotherapy|25 Gy in 5 fractions over 5 days.
12055961|NCT00145769|Radiation|Long Course Radiotherapy|50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.
12055962|NCT00145769|Drug|Concurrent Chemotherapy|5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).
12055963|NCT00145769|Procedure|Initial Surgery|Surgery is to be performed according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Elective surgery for rectal cancer
12055964|NCT00145756|Drug|low sodium high potassium salt substitute|
12055965|NCT00145743|Behavioral|physio,pain,psychotherapy;social,nutrit.counselling&sports|profile and treatment recommendations based on the profile vs. routine psychooncology
12055966|NCT00145730|Drug|Ibuprofen|
12055967|NCT00145717|Drug|Plant sterol enriched milk tea|
12055968|NCT00145704|Drug|bisphosphonate therapy (risedronate)|Bisphosphonate therapy given to patients with growth hormone deficiency
12055969|NCT00145704|Dietary Supplement|Vitamin D supplement|Vitamin D given to patients with growth hormone deficiency
12055970|NCT00145704|Dietary Supplement|Calcium|calcium supplement given to patients with growth hormone deficiency
12055971|NCT00145691|Drug|Oxcarbazepine|
12055972|NCT00145678|Behavioral|Psychodynamic Therapy|Dynamic deconstructive psychotherapy is a time-limited (12-18 month) manual-based form of psychodynamic therapy that aims to remediate specific neurocognitive capacities responsible for processing of emotional experiences.
12055973|NCT00145678|Behavioral|Optimized Community Care|individual and group psychotherapy in a private practice, clinic, and/or rehab setting, with an eclectic orientation
12055974|NCT00145665|Procedure|FLT-PET scan|PET scan using FLT
12055975|NCT00145652|Drug|Neo-Recormon and Venofer|
12055976|NCT00145639|Drug|Ifosfamide, Carboplatin, Doxorubicin|See Detailed Description for treatment plan.
12055977|NCT00145639|Procedure|Limb Sparing|See Detailed Description for treatment plan.
12055978|NCT00145626|Drug|Chemotherapy and antibodies|Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants will receive an infusion of additional donor derived cells called NK cells.
12055979|NCT00145626|Device|Miltenyi Biotec CliniMACS|Stem cell selection device
12055980|NCT00145626|Procedure|Allogeneic stem cell transplantation|Allogeneic natural killer (NK)cell infusion
12055981|NCT00145613|Procedure|Stem Cell Transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
12055982|NCT00145613|Device|Miltenyi Biotec CliniMACS|stem cell selection device
12055983|NCT00145613|Drug|Systemic chemotherapy and antibodies|Transplant recipients received a non-TBI based reduced intensity conditioning regimen consisting of OKT-3, Fludarabine Thiotepa, and Melphalan. Rituximab was administered within 24 hours of the transplant in an effort to prevent PTLPD. In addition to T-cell depletion of the haploidentical stem cell product, Mycophenolate mofetil was provided as prophylaxis for GVHD.
12055984|NCT00145600|Drug|12 Week Stanford V Chemotherapy|12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children
12055985|NCT00145600|Drug|4 cycles of VAMP chemotherapy|4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.
12055986|NCT00145600|Drug|2 alternating cycles of VAMP/COP chemotherapy|2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.
12055987|NCT00145600|Drug|3 alternating cycles of VAMP/COP chemotherapy|3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT
12055988|NCT00145587|Procedure|Stem Cell Transplantation|An infusion of HLA partially matched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
12055989|NCT00145587|Device|Miltenyi Biotec CliniMACS|Stem cell selection device
12055990|NCT00145587|Drug|Systemic chemotherapy and antibodies|"Haploidentical stem cell transplant recipients will receive a reduced intensity conditioning regimen consisting of OKT-3, Fludarabine, Thiotepa , and Melphalan followed by an infusion of a T-cell depleted donor stem cell product. Rituximab will be administered within 24 hours of the infusion in an effort to prevent post transplantation lymphoproliferative disorders (PTLPD). In addition to T-cell depletion of the donor product, cyclosporine will be provided as prophylaxis for (GVHD)Graft versus Host Disease
~Recipients of a matched sibling donor product will receive a myeloablative conditioning regimen consisting of busulfan and cyclophosphamide. Cyclosporine will be administered for GVHD prophylaxis."
12055991|NCT00145574|Drug|colesevelam HCl|Tablets
12055992|NCT00145574|Drug|placebo|Matching Tablets
12055993|NCT00145561|Drug|Saquinavir and Ritonavir|
12055994|NCT00145548|Device|Intra Bronchial Valve|
12055995|NCT00145535|Device|SOLX Titanium Sapphire Laser (TiSaLT)|Spot laser treatment, ~50 spots over 180°
12055996|NCT00145535|Device|Argon Laser Trabeculoplasty (ALT)|Spot laser treatment, ~50 spots over 180°
12055997|NCT00145522|Drug|17ß-Estradiol/Dydrogesterone|1/5 mg/day for 12 cycles of 28 days
12055998|NCT00145522|Drug|Tibolone|2,5 mg/day for 12 cycles of 28 days
12055999|NCT00145509|Drug|Asenapine|Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
12056000|NCT00145509|Drug|Placebo|Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks
12056001|NCT00145496|Drug|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
12056002|NCT00145496|Drug|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
12056003|NCT00145483|Drug|Sildenafil|
12056004|NCT00145470|Drug|Asenapine|Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.
12056005|NCT00145470|Drug|Placebo|Placebo fast dissolving SL tablets, BID
12056006|NCT00145457|Procedure|Blood sample|
12056007|NCT00145457|Procedure|Radiography|
12056008|NCT00145444|Drug|olanzapine|
12056009|NCT00145444|Drug|ziprasidone|
12056010|NCT00145431|Drug|torcetrapib/atorvastatin|
12056011|NCT00145431|Drug|atorvastatin|
12056012|NCT00145431|Drug|fenofibrate|
12056013|NCT00145418|Drug|Oxaliplatin + Docetaxel|Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
12056014|NCT00145405|Drug|Lanreotide Autogel and Octreotide LAR|
12056015|NCT00145379|Drug|Tablet Metformin 500 mg|
12056016|NCT00145379|Drug|Placebo|
12056017|NCT00145366|Drug|Recombinant human thyrotropin (Thyrogen)|
12056018|NCT00145353|Drug|Insulin NovoRapid versus Actrapid|
12056019|NCT00145340|Drug|pioglitazone|30 Mg/day
12056020|NCT00145327|Drug|Zoledronic Acid|Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
12056021|NCT00145327|Drug|Placebo|100 mL physiologic 0.9% normal saline for intravenous infusion.
12056022|NCT00145314|Drug|FLOX (5-fluorouracil/folinic acid/oxaliplatin)|FLOX every 2nd week
12056023|NCT00145314|Drug|FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab|FLOX every 2nd week Cetuximab weekly
12056024|NCT00145314|Drug|FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab|"FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced.
~Cetuximab weekly."
12056025|NCT00145301|Drug|Lumiracoxib|
12056026|NCT00145275|Drug|zoledronic acid|
12056027|NCT00145262|Procedure|Autologous Bone Marrow Mononuclear Cell Implantation|
12056028|NCT00145249|Drug|Amphotericin B|Amphotericin B 0.7 mg/kg IV for the first 14 days of treatment. This period may be extended up to an additional 7 days.
12056029|NCT00145249|Drug|Fluconazole|Fluconazole 400 or 800 mg daily. Among subjects whose baseline weight is less than 40 kg, randomized fluconazole doses will be 200 mg/kg daily or 400 mg/kg daily.
12056030|NCT00145236|Drug|Nebivolol|
12056031|NCT00145210|Drug|Nebivolol and Atenolol|
12056032|NCT00145197|Behavioral|Improving the Delivery of Effective Care to Minorities|The intervention consists of: a) reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. We will recruit all physicians who treat patients with early stage breast cancer. Physicians who agree to participate will identify a point person in their office who will inform the research team if the patient has a follow up appointment with radiation or medical oncologists. Following the appointment date, we will contact each office to confirm the patient's visit. If the patient has connected with radiation and/or medical oncologist, we will let the surgeon's office know and stop calling his/her office. However, if the patient has not made the appropriate visits, we will continue to call the surgeon's office every week for a total of 3 calls to let them know that the patient has not connected with the oncologist.
12056033|NCT00145184|Dietary Supplement|Multivitamin supplement containing vitamins B, C, and E|A daily oral dose of between 1.5 to 3 times the age- appropriate Recommended Dietary Allowance (RDA) of each vitamin taken for two months starting at enrollment.
12056034|NCT00145184|Drug|Placebo|Placebo pill taken orally once per day for two months starting at enrollment.
12056035|NCT00145171|Drug|apomorphine HCl injection|
12056036|NCT00145158|Biological|8 HLA-A2 restricted peptides and Montanide ISA-51|
12056037|NCT00145145|Biological|MAGE-3.A1 peptide and CpG 7909|
12056038|NCT00145132|Procedure|β-CIT-SPECT, Neurophysiology|β-CIT-SPECT scans and EEG recordings, two assessments each
12056039|NCT00145106|Drug|Tazarotene 0.1% gel + placebo capsule, Oral minocycline (100 mg capsule) + vehicle gel, Tazarotene 0.1% gel + oral minocycline (100 mg capsule)|
12056040|NCT00145093|Drug|Baker's yeast (Bio Chromium)|
12056041|NCT00145080|Behavioral|Disease Management Assessment|
12056042|NCT00145067|Behavioral|Disease Management Assessment|
12056043|NCT00145054|Behavioral|MoodHelper Internet program for Depression Self-Help|
12056044|NCT00145041|Drug|Vincristine Sulfate Liposomes Injection|Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
12056045|NCT00145028|Drug|Carboplatin|
12056046|NCT00145015|Behavioral|Increased dietary intake of salmon or cod|
12056047|NCT00145002|Drug|VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis|
12056048|NCT00145002|Drug|biweekly-CHOP with G-CSF and intrathecal prophylaxis|
12056049|NCT00144989|Drug|Etoposide and cisplatin after chemoradiotherapy|Etoposide and cisplatin after chemoradiotherapy
12056050|NCT00144989|Drug|Irinotecan and cisplatin after chemoradiotherapy|Irinotecan and cisplatin after chemoradiotherapy
12056051|NCT00144976|Drug|Tarceva|Tarceva will be administered at dosage 150 mg od one hour before or two hours after meat. Patients will receive Tarceva between 18 and 28 days.
12056052|NCT00144963|Drug|Vincristine Sulfate Liposomes Injection|Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).
12056053|NCT00144963|Drug|Dexamethasone|Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).
12056054|NCT00144950|Drug|insertion of a chest drain with urokinase instillation|
12056055|NCT00144950|Procedure|primary video-assisted thorascopic surgery|
12056056|NCT00144937|Drug|Stepwise therapy for dyslipidemia, hypertension and diabetes|
12056057|NCT00144937|Behavioral|Dietary recommendations|
12056058|NCT00144937|Behavioral|Increase in physical activity|
12056059|NCT00144937|Behavioral|Smoking cessation|
12056060|NCT00144924|Procedure|pyloromyotomy|laparoscopic pyloromytomy
12056061|NCT00144911|Drug|Salmeterol|
12056062|NCT00144911|Drug|Fluticasone Propionate/Salmeterol Combination Product|
12056063|NCT00144898|Procedure|Sentinel Node Resection|Sentinel Node Resection
12056064|NCT00144898|Procedure|Conventional Axillary Dissection|Conventional Axillary Dissection
12056065|NCT00144885|Behavioral|Modification of therapy|Modification of the surgery date if adapted, modification of the antibiotics if adapted, based on RMI results
12056066|NCT00144872|Drug|Lamotrigine|Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.
12056067|NCT00144859|Drug|SB681323|
12056068|NCT00144846|Drug|albuterol sulfate inhalation aerosol|
12056069|NCT00144833|Drug|fosamprenavir/ritonavir (700mg/100mg BID)|
12056070|NCT00144833|Drug|fosamprenavir/ritonavir (1400mg/100mg BID)|
12056071|NCT00144833|Drug|fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)|
12056072|NCT00144820|Drug|Injection of Hyaluronan or Saline|
12056073|NCT00144807|Drug|rituximab|
12056074|NCT00144807|Drug|doxorubicin|
12056075|NCT00144807|Drug|cyclophosphamide|
12056076|NCT00144807|Procedure|autologous stem cell transplantation|
12056077|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|0.58 mg/kg every week
12056078|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|1.2 mg/kg every week
12056079|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|1.2 mg/kg every other week
12056080|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|1.8 mg/kg every other week
12056081|NCT00144768|Drug|laronidase|dose of 0.58mg/kg body weight IV every week
12056082|NCT00144755|Drug|Darbepoetin alfa|prophylactic administration of darbepoetin alfa in experimental arm
12056083|NCT00144729|Procedure|Bone marrow transplant|
12056084|NCT00144716|Device|Insect Repellent plus Insecticide Treated Net|
12056085|NCT00144703|Drug|Sirolimus|
12056086|NCT00144703|Drug|Tacrolimus|
12056087|NCT00144690|Drug|E2007 (perampanel)|
12056088|NCT00144690|Drug|Placebo|
12056089|NCT00144677|Drug|sirolimus|
12056090|NCT00144677|Drug|tacrolimus|
12056091|NCT00144664|Drug|MRA(Tocilizumab)|
12056092|NCT00144651|Drug|MRA(Tocilizumab)|8mg/kg/4 weeks for 1 year
12056093|NCT00144625|Drug|MRA(Tocilizumab)|8mg/kg/4weeks
12056094|NCT00144612|Drug|MRA(Tocilizumab)|8mg/kg/2weeks
12056095|NCT00144599|Drug|MRA(Tocilizumab)|
12056096|NCT00144599|Drug|placebo|
12056097|NCT00144586|Drug|MRA(Tocilizumab)|8mg/kg/4 weeks
12056098|NCT00144573|Drug|MRA(Tocilizumab)|
12056099|NCT00144560|Drug|MRA(Tocilizumab)|
12056100|NCT00144547|Drug|MRA(Tocilizumab)|8mg/kg(i.v.)/4weeks
12056101|NCT00144534|Drug|MRA (Tocilizumab)|8mg/kg/4 weeks
12056102|NCT00144521|Drug|MRA(Tocilizumab)|8mg/kg/4week(i.v.)for 24 weeks
12056103|NCT00144521|Drug|MRA placebo|0mg/kg/4week(i.v.) for 24 weeks
12056104|NCT00144521|Drug|MTX|8mg/week(p.o.) for 24 weeks
12056105|NCT00144521|Drug|MTX placebo|0mg/week(p.o.) for 24 weeks
12056106|NCT00144508|Drug|MRA (Tocilizumab)|8mg /kg /4week for 52 weeks
12056107|NCT00144508|Other|current treatment|continue current treatment
12056108|NCT00144495|Drug|recombinant human erythropoietin|3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
12056109|NCT00144495|Drug|recombinant human erythropoietin|36000IU(s.c.)/week for 12 weeks
12056110|NCT00144482|Drug|recombinant human erythropoietin|36000IU（0.5mL）s.c./week for 8 weeks
12056111|NCT00144482|Drug|recombinant human erythropoietin placebo|0 IU(0.5mL)s.c./week for 8 weeks
12056112|NCT00144469|Drug|peginterferon alfa-2a|
12056113|NCT00144469|Drug|rivavirin|
12056114|NCT00144456|Drug|ED-71|0.75μg/day(p.o.)for 144 weeks
12056115|NCT00144456|Drug|Alfacalcidol|1.0μg/day(p.o.)for 144 weeks
12056302|NCT00142844|Drug|Placebo|
12056116|NCT00144456|Drug|ED-71 placebo|0 μg/day(p.o.)for 144 weeks
12056117|NCT00144456|Drug|Alfacalcidol placebo|0 μg/day(p.o.)for 144 weeks
12056118|NCT00144443|Behavioral|Basic home repair|
12056119|NCT00144443|Behavioral|Asthma Trigger Education|
12056120|NCT00144430|Drug|Pentostatin|The drug, Pentostatin, is given every 2 weeks. This drug will be given by intravenous (IV) infusion.
12056121|NCT00144417|Drug|Moxifloxacin (with rifampin, pyrazinamide, and ethambutol)|Moxifloxacin 400mg daily, 8 weeks
12056122|NCT00144417|Drug|isoniazid|isoniazid, oral, 300 mg, daily, 8 weeks
12056123|NCT00144391|Drug|Transdermal Testosterone gel|2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
12056124|NCT00144378|Drug|Irinotecan|
12056125|NCT00144365|Drug|Antiretroviral therapy|
12056126|NCT00144352|Drug|sulfadoxine-pyrimethamine|
12056127|NCT00144339|Drug|tiotropium|
12056128|NCT00144339|Drug|placebo|
12056129|NCT00144326|Drug|Tiotropium Bromide|
12056130|NCT00144326|Drug|Placebo|
12056131|NCT00144313|Biological|hepatitis B vaccine|
12056132|NCT00144300|Drug|Mirapex|Standard marketed product dispensed according to manufacturer's guidelines
12056133|NCT00144300|Drug|Requip|Standard marketed product dispensed according to manufacturer's guidelines
12056134|NCT00144287|Drug|Tipranavir/Ritonavir|
12056135|NCT00144274|Drug|Ambroxol Lozenge|
12056136|NCT00144261|Drug|nevirapine|
12056137|NCT00144248|Drug|nevirapine|
12056138|NCT00144235|Drug|Pharmaton PHL 00749|
12056139|NCT00144235|Drug|Placebo|
12056140|NCT00144222|Drug|Telmisartan 40 mg/HCTZ 12.5 mg|
12056141|NCT00144222|Drug|Telmisartan 40 mg|
12056142|NCT00144209|Drug|pramipexole|
12056143|NCT00144209|Drug|levodopa in combination with benserazide|
12056144|NCT00144196|Drug|tiotropium (Spiriva)|
12056145|NCT00144183|Drug|Nevirapine (NVP)|Nevirapine 200mg once daily for 14 days followed by 200mg twice daily thereafter for the remainder of the treatment period. Combivir®, one tablet twice daily.
12056146|NCT00144183|Drug|Zidovudine (ZCV)|
12056147|NCT00144183|Drug|3TC|
12056148|NCT00144170|Drug|Tipranavir (with low dose ritonavir)|
12056149|NCT00144170|Drug|Comparator protease inhibitor(CPI)/low dose ritonavir(r)|
12056150|NCT00144157|Drug|Nevirapine|
12056151|NCT00144157|Drug|Zidovudine|
12056152|NCT00144157|Drug|3TC|
12056153|NCT00144144|Drug|Angiotensin II receptor antagonists, Calcium channel blocker|
12056154|NCT00144131|Drug|Aranesp®|
12056155|NCT00144118|Drug|sevoflurane or isoflurane|
12056156|NCT00144105|Drug|TPV500mg/RTV200mgBID|
12056157|NCT00144105|Drug|TPV500mg/RTV100mgBID|
12056158|NCT00144105|Drug|LPV400mg/RTV100mgBID|
12056159|NCT00144092|Procedure|stem cell source|
12056160|NCT00144079|Procedure|external beam radiotherapy|
12056161|NCT00144066|Drug|platinum-based chemotherapy alone (up to six cycles)|
12056162|NCT00144066|Drug|platinum-based chemotherapy followed by maintenance therapy with gefitinib|
12056163|NCT00144053|Drug|Cisplatin+Vindesine+MMC/ concurrent radiation|
12056164|NCT00144053|Drug|Irinotecan+Carboplatin/concurrent radiation|
12056165|NCT00144053|Drug|Paclitaxel+Carboplatin/concurrent radiation|
12056166|NCT00144040|Behavioral|Physician & patient education on appropriate antibiotic use|
12056167|NCT00144040|Procedure|Rapid C-reactive protein testing to guide antibiotic treatment|
12056168|NCT00144027|Behavioral|Antipsychotic medication adherence intervention|The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.
12056169|NCT00144014|Drug|V10153|Single acute intravenous bolus dose up to 10 mg/kg
12056170|NCT00143988|Behavioral|Treadmill testing|Patients will have a exercise stress test using a Bruce protocol during which time heart rates and blood pressures will be monitored and the patient's percieved exertion level monitored and recorded
12056171|NCT00143988|Behavioral|Ambulatory Blood Pressure and Heart Rate Monitoring|Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter.
12056172|NCT00143975|Drug|Cytarabine|3 g/m2 bid. i.v day 1-3
12056173|NCT00143975|Drug|Mitoxantrone|12 mg/m2 i.v. day 2 and 3
12056174|NCT00143975|Drug|Gemtuzumab Ozogamicin|3mg/m² i.v. day 1
12056175|NCT00143975|Drug|All-trans-Retinoid Acid|45 mg/m2 p.o. day 4-6 15 mg/m2 p.o. day 7-28
12056176|NCT00143962|Behavioral|Low Carbohydrate Diet|
12056177|NCT00143949|Drug|enalapril|
12056178|NCT00143949|Drug|losartan|
12056179|NCT00143936|Behavioral|Low- Carbohydrate -Atkins Diet|Low Carbohydrate Diet
12056180|NCT00143936|Behavioral|Low Calorie Diet|Maintain a low calorie diet
12056181|NCT00143923|Behavioral|Nutrition, Exercise, Stress Management Counseling|Individualized advice
12056182|NCT00143923|Other|usual care|usual care
12056183|NCT00143910|Other|observation|
12056184|NCT00143884|Procedure|Reduced intensity conditioning|
12056185|NCT00143884|Procedure|Prophylactic donor leukocyte infusions|
12056186|NCT00143871|Drug|Rituximab|
12056187|NCT00143858|Device|Pulse Volume Measurement|patients will wear a newly designed calf monitor that will be hooked up to a computer that will monitor leg peripheral pulse volumes which will then be correlated to pressures obtained with Swan Ganz monitoring. The calf monitor is gut two bands with sensors that are wrapped around the ankle and below the knww
12056188|NCT00143845|Procedure|Reduced intensity conditioning|Busulfan and Fludarabine regimen
12056189|NCT00143845|Procedure|Rapid immunosuppressive taper|Taper of Tacrolimus, Methotrexate and Mycophenolate Mofetil
12056190|NCT00143845|Procedure|Prophylactic donor leukocyte infusions|If the patient has GVHD overall grade 0-1 or skin grade 1 on day +100, then 5 x 107 CD3+ cells/kg recipient weight are given.
12056191|NCT00143819|Drug|Neuroskin Forte|Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
12056192|NCT00143819|Drug|Placebo Application|Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
12056193|NCT00143806|Drug|Transitioning patients from cyclosporine to alefacept|
12056194|NCT00143780|Biological|The polysaccharide vaccine used is Pneumovax (Merck vaccines)|
12056195|NCT00143780|Biological|The conjugate vaccine used is Prevnar (Wyeth-Ayerst vaccines)|
12056196|NCT00143754|Procedure|Hydration|
12056197|NCT00143741|Drug|Atorvastatin (Lipitor)|20mg every day, taken by mouth. Dose could be increased up to 60mg every day during the course of the trial if tests indicate this is needed.
12056198|NCT00143728|Drug|Lamivudine|See Detailed Description.
12056199|NCT00143715|Drug|Phytonadione (Vitamin K1)|1.25 mg given orally
12056200|NCT00143702|Drug|d4T|See Detailed Description.
12056201|NCT00143702|Drug|Abacavir|See Detailed Description.
12056202|NCT00143702|Drug|Riboflavin and Thiamine (Supplementation)|See Detailed Description.
12056203|NCT00143689|Drug|lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine|See Detailed Description.
12056204|NCT00143676|Drug|Lapaquistat acetate and atorvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
12056205|NCT00143676|Drug|Lapaquistat acetate and atorvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
12056206|NCT00143676|Drug|Atorvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
12056207|NCT00143663|Drug|Lapaquistat Acetate|Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 12 weeks
12056208|NCT00143663|Drug|Placebo|Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks
12056209|NCT00143650|Behavioral|House dust|
12056210|NCT00143637|Other|Office dust|airborne office dust spiked with glucan
12056211|NCT00143637|Other|clean air|Clean air
12056212|NCT00143624|Drug|Rosiglitazone maleate|See Detailed Description.
12056213|NCT00143624|Drug|Placebo|See detailed description.
12056214|NCT00143611|Drug|Resatorvid|Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.05 mg/kg/h (1.2 mg/kg/day), injection, subcutaneously over 96 hours.
12056215|NCT00143611|Drug|Resatorvid|Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.1 mg/kg/h (2.4 mg/kg/day), injection, subcutaneously over 96 hours.
12056216|NCT00143611|Drug|Placebo|Resatorvid placebo-matching injection, subcutaneously for thirty minutes; then resatorvid placebo-matching injection, subcutaneously over 96 hours.
12056217|NCT00143598|Device|Knee-length, graduated elastic compression stocking|Worn daily for 2 years, 30-40 mm Hg
12056218|NCT00143598|Device|Knee-length, placebo stocking|Worn daily for two years
12056219|NCT00143585|Procedure|intramyocardial delivery of either VEGF165 or placebo|
12056220|NCT00143572|Drug|Magnesium Pidolate, Hydroxyurea|Intervention Description: Mg pidolate in combination with HU in patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU for at least 6 months. Mg pidolate will be given at an initial dose of 0.6 mEq/kg/day divided into 2 daily doses for the first cohort of patients. This dose will be escalated for the subsequent patient cohorts as defined by a classic Phase I design (according to toxicity).
12056221|NCT00143559|Drug|Systematic chemotherapy and antibodies|"Systemic chemotherapy and antibodies as follows:
~Transplant recipients received a reduced intensity conditioning regimen consisting of OKT-3, fludarabine, thiotepa, and melphalan followed by an infusion of a T-cell depleted haploidentical hematopoietic stem cell graft. The antibody Rituximab was administered within 24 hours of the infusion in an effort to prevent PTLPD. In addition to T -cell depletion of the donor product, Mycophenylate mofetil was provided over several months as prophylaxis for GVHD"
12056222|NCT00143559|Procedure|Allogeneic stem cell transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device
12056223|NCT00143559|Device|Miltenyi CliniMACS|Miltenyi Biotec CliniMACS stem cell selection device
12056224|NCT00143546|Drug|Defibrotide|Defibrotide to be administered approximately every 6 hours at an initial dose of 6.25 mg/kg/dose. Subsequent doses will be escalated with a plateau of 15 mg/kg/dose (or 60 mg/kg/day total). For patients with persistent VOD, the dose may be escalated by 10 mg/kg/day as needed to a maximum of 110 mg/kg/day total.
12056225|NCT00143533|Drug|Irinotecan, Cefpodoxime|See Detailed description section for treatment details.
12056226|NCT00143520|Drug|Rivoglitazone|
12056227|NCT00143520|Drug|Pioglitazone|
12056228|NCT00143520|Drug|Placebo|
12056229|NCT00143507|Drug|Ivabradine|
12056230|NCT00143507|Drug|Placebo|
12056231|NCT00143494|Procedure|measurement of abdominal pressure|measurement of abdominal pressure with different volume and saline temperature
12056232|NCT00143481|Drug|Tolterodine ER 4mg QD|
12056233|NCT00143468|Behavioral|mechanical ventilation|measurement of specific lung elastance during mechanical ventilation
12056234|NCT00143455|Drug|Etoposide + cisplatin|etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
12056235|NCT00143455|Drug|Irinotecan + cisplatin|irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
12056236|NCT00143442|Drug|[S,S]-Reboxetine|
12056237|NCT00143429|Drug|Xalatan|
12056238|NCT00143416|Drug|Pegvisomant|
12056239|NCT00143403|Drug|Irinotecan + 5 FU + folinic acid|irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
12056240|NCT00143403|Drug|Folinic Acid + 5 FU|folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
12056241|NCT00143390|Drug|exemestane|take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
12056242|NCT00143390|Drug|anastrozole|take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal
12056243|NCT00143377|Drug|tolterodine SR, overactive bladder|
12056244|NCT00143364|Drug|varenicline (CP-526,555)|
12056245|NCT00143351|Drug|Ziprasidone|
12056246|NCT00143338|Drug|Inhaled insulin|
12056247|NCT00143325|Drug|varenicline (CP-526,555)|
12056248|NCT00143312|Drug|voriconazole|Voriconazole is given to patients at least 48 hours after chemotherapy
12056249|NCT00143299|Drug|varenicline (CP-526,555)|
12056250|NCT00143286|Drug|varenicline (CP-526,555)|
12056251|NCT00143273|Drug|lasofoxifene|0.05 mg tablets
12056252|NCT00143273|Drug|Placebo|0 mg
12056253|NCT00143273|Drug|Lasofoxifene|0.25 mg tablets
12056254|NCT00143273|Drug|Lasofoxifene|0.5 mg tablets
12056255|NCT00143260|Drug|Viagra (Sildenafil Citrate) 100 mg|
12056256|NCT00143247|Drug|Exubera® (inhaled insulin)|Treatment of type 1 and type 2 diabetes with short-acting insulin
12056257|NCT00143234|Drug|Amlodipine/atorvastatin single pill|
12056258|NCT00143221|Drug|Viagra|
12056259|NCT00143221|Drug|Placebo|
12056260|NCT00143208|Drug|Xalacom|
12056261|NCT00143195|Drug|Amlodipine|
12056262|NCT00143195|Drug|iso- 5 - mononitrate|
12056263|NCT00143195|Procedure|Blood tests|
12056264|NCT00143195|Procedure|Exercise Stress Test|
12056265|NCT00143182|Drug|Asenapine|Asenapine , 9 weeks
12056266|NCT00143182|Drug|Olanzapine|Olanzapine, 9 weeks
12056267|NCT00143169|Drug|Parecoxib and placebo|
12056268|NCT00143156|Drug|pregabalin|
12056269|NCT00143143|Drug|Pregabalin|
12056270|NCT00143130|Drug|Pregabalin|Pregabalin
12056271|NCT00143117|Drug|UK-390,957|
12056272|NCT00143104|Drug|Inhaled insulin|
12056273|NCT00143091|Drug|CP-316,311|
12056274|NCT00143091|Drug|Placebo|
12056275|NCT00143091|Drug|Sertraline|
12056276|NCT00143065|Drug|Fludarabine|25 mg/m2/day for 5 days every 28 days (Week 2,6,10,14, 18,and 22) will be administered by IV over 10-30 minutes. (Fludarabine should be given AFTER rituximab on all days on which both drugs will be administered.)
12056277|NCT00143065|Drug|Rituximab|"Day 1, week 2 of cycle 1 rituximab 100 mg will be administered by IV, without dose escalation, over 4 hours (rate: 25 mg/hr). Day 3, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 50 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
~On Day 5, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 100 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
~Rituximab 375 mg/m2 will be repeated on Day 1 of Week 6, 10, 14, 18, and 22. During these treatments, acetaminophen and diphenhydramine prophylactic treatment is left to the discretion of the treating physician."
12056278|NCT00143065|Drug|Alemtuzumab|The dose of alemtuzumab will be escalated during Week 1 of therapy. On Day 1 of Week 1, a dose of 3 mg should be administered IV over 2-hours. If this dose is well tolerated(grade 2 or less infusion or skin related toxicity), then the dose on Day 2 can be increased to 10 mg IV over 2 hours. If this dose is well tolerated, then the dose on Day 3 will be increased to 30 mg IV over 2-hours, and if tolerated, then day 5 and all subsequent alemtuzumab doses will be 30 mg. Vital signs (blood pressure, pulse, respiration rate,temperature, and O2 saturation) and skin assessment should be assessed at baseline, 1-hour, and 1-hour post administration during week 1 and 2. Following successful escalation to 30 mg of alemtuzumab, all subsequent doses of alemtuzumab will be 30 mg administered on the second day of fludarabine therapy (week 2,6,10,14,18,and 22).
12056279|NCT00143039|Procedure|Tandem MS test for inborn errors of metabolism|Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.
12056280|NCT00143026|Drug|carbidopa, levodopa, entacapone|
12056281|NCT00143000|Drug|Peginterferon alfa-2a 40KD and Ribavirin|
12056282|NCT00142987|Drug|Tegaserod|
12056283|NCT00142974|Drug|Tegaserod|
12056284|NCT00142961|Drug|Atomoxetine|atomoxetine
12056285|NCT00142961|Other|placebo|
12056286|NCT00142948|Drug|Naltrexone|naltrexone
12056287|NCT00142948|Drug|Placebo|placebo
12056288|NCT00142935|Behavioral|Pre-release Initiation of MMT|Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
12056289|NCT00142935|Behavioral|Post Release Initiation of MMT.|Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
12056290|NCT00142935|Behavioral|Standard of Care Plus|Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
12056291|NCT00142922|Behavioral|Breaking Down Barriers|completed
12056292|NCT00142909|Drug|Lofexidine|Participants will receive lofexidine. The dosing will be initiation at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.
12056293|NCT00142909|Drug|Placebo|Lofexidine Placebo
12056294|NCT00142896|Drug|Tramadol|
12056295|NCT00142896|Drug|Naloxone|
12056296|NCT00142896|Drug|Morphine|
12056297|NCT00142883|Drug|Pregabalin|pregabalin compared to placebo
12056298|NCT00142883|Drug|placebo|sugar pill compared to pregabalin
12056299|NCT00142870|Drug|Bupropion|150 mg, twice a day
12056300|NCT00142844|Drug|Naltrexone|
12056301|NCT00142844|Drug|Disulfiram|
12056303|NCT00142831|Drug|Pharmacotherapies for Smoking Cessation|Bupropion-SR or Identical Placebo
12056304|NCT00142818|Drug|Naltrexone|150 mg daily for males; 100 mg daily for females
12056305|NCT00142818|Drug|Modafinil|400 mg daily
12056306|NCT00142818|Drug|Placebo|400 mg and/or 100-150 mg placebo pills
12056307|NCT00142805|Drug|Tricaprilin|Powder formulation will be mixed in a liquid (approximately 8 oz).
12056308|NCT00142805|Other|Placebo|Powder formulation will be mixed in a liquid (approximately 8 oz).
12056309|NCT00142792|Device|NMES device with EMG-triggered and Cyclic capabilities|All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
12056310|NCT00142779|Drug|Fluoxetine|
12056311|NCT00142766|Behavioral|Nurse Implemented Goal-Directed Comfort Algorithm|See description
12056312|NCT00142753|Biological|Engerix B|Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.
12056313|NCT00142753|Biological|Twinrix for ATN 024|Standard adult dosage, taken at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at week 48.
12056314|NCT00142753|Biological|Recombivax|Dosage at entry and week 24; non-responders ((<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive 3rd dose of Recombivax during weeks 48-72.
12056315|NCT00142753|Biological|Twinrix for ATN 025|Doses at Entry and Week 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive a dose of Recombivax during week 48-72.
12056316|NCT00142727|Drug|Methadone|
12056317|NCT00142727|Drug|Full opioid agonist|
12056318|NCT00142727|Drug|Partial opioid agonist|
12056319|NCT00142727|Drug|Opioid antagonist|
12056320|NCT00142714|Procedure|Sympathetic manipulation on sexual arousal in women|
12056321|NCT00142701|Behavioral|diet|
12056322|NCT00142701|Behavioral|physical activity|
12056323|NCT00142701|Behavioral|stress management|
12056324|NCT00142701|Behavioral|smoking cessation|
12056325|NCT00142688|Behavioral|Physical activity|Tailored print-based intervention in which participants complete questionnaires and receive tailored feedback based on responses to the questionnaires. The intervention is delivered monthly during the first month, bi-monthly during months 2 and 3, and monthly during months 4-6. The intervention is completed through the mail.
12056326|NCT00142688|Behavioral|Wellness|Participants receive wellness materials delivered through the mail on the same schedule as the experimental condition. Physical activity materials are given to this group upon completion of the study.
12056327|NCT00142675|Behavioral|Physical Activity|
12056328|NCT00142662|Behavioral|diet|
12056329|NCT00142662|Behavioral|financial incentives|
12056330|NCT00142649|Behavioral|diet|
12056331|NCT00142649|Behavioral|physical activity|
12056332|NCT00142623|Behavioral|Tailored DVDs|Five DVDs aimed at reducing exposure to ETS
12056333|NCT00142610|Dietary Supplement|Vitamin|This is designed as a placebo controlled study of 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks, on airway antioxidant levels in asthmatics.
12056334|NCT00142597|Device|Acupuncture|"Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.
~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.
~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
12056335|NCT00142597|Other|Sham treatment|"Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.
~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
12056336|NCT00142584|Drug|Nebivolol|Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.
12056337|NCT00142584|Drug|Metoprolol|Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.
12056338|NCT00142571|Drug|Gemcitabine|
12056339|NCT00142571|Drug|Docetaxel|
12056340|NCT00142558|Drug|MK0663; etoricoxib / Duration of Treatment: 5 Days|
12056341|NCT00142558|Drug|Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days|
12056342|NCT00142545|Drug|apomorphine HCl injection|
12056343|NCT00142532|Procedure|Acupuncture and Questionnaires|"Acupuncture 30 day treatment BL12 - 19 and extra point Wei Guan Xia Shu Each side of the spine,1.5 cun (~2.5cm) lateral to the lower border of spinous process of the T2 - 10 spinal vertebrae respectively 4 weeks ST36, Below the knee, 3 cun (~7.5cm) inferior to the lower border of the patella, one finger breadth lateral to the anterior crest of the tibia. One week following removal of epidural.
~Shenmen, bilaterally. At the lateral 1/3 of the triangular fossa in the auricle.One week following removal of epidural.
~Questionnaires 30 / 60 / 90 Day and 12 Month Follow-up-Numerical rating scale of pain; total opioid use; Medication Quantification Scale; length of stay; Brief Pain Inventory"
12056344|NCT00142532|Procedure|Placebo Acupuncture, Questionnaires|"The back studs will be placed halfway between the upper and lower border of spinous processes T2 to T10, approximately 0.5 cun (~1.25cm) from the spine. The leg studs will be placed at 2 cun (~5cm) posterior to GB34 on the posterior of the lower leg. No studs will be placed in the ear; rather studs will be placed on the anterior arm, 3 cun (~ 5cm) proximal and 3 cun (~ 5cm) medial to the midpoint of the antecubital crease.
~Pain will be assessed by a 0 - 10 point numerical rating scale (NRS) marked no pain at one end and worst pain at the other."
12056345|NCT00142519|Drug|Methadone|Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
12056346|NCT00142519|Drug|methadone and morphine|Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg
12056385|NCT00142220|Drug|Defined percentage of omega-3-fatty acids|
12056386|NCT00142207|Drug|Intermittent preventive treatment:sulphadoxine-pyrimethamine|Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
12056347|NCT00142506|Drug|sildenafil citrate and questionaires|"Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.
~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
12056348|NCT00142506|Drug|placebo tablets and questionaires|"Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.
~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.
~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
12056349|NCT00142493|Drug|Propofol|1.2ug/ml
12056350|NCT00142493|Drug|Thiopental Sodium|2.0ug/ml
12056351|NCT00142493|Drug|Dexmedetomidine Hydrochloride|0.5ng/ml
12056352|NCT00142493|Drug|Midazolam Hydrochloride|60ng/ml
12056353|NCT00142493|Drug|placebo|intralipid, saline, saline with multi-Vit solution
12056354|NCT00142480|Drug|Capecitabine|Given orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28).
12056355|NCT00142480|Drug|Oxaliplatin|Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29
12056356|NCT00142480|Drug|Bevacizumab|Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.
12056357|NCT00142480|Procedure|Radiation therapy|Once daily for 5 days (Monday through Friday) for a total of 28 treatments.
12056358|NCT00142467|Drug|Gemcitabine|
12056359|NCT00142467|Drug|Oxaliplatin|
12056360|NCT00142467|Drug|Bevacizumab|
12056361|NCT00142454|Drug|Imiquimod|Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner thighs) in each cycle. The cream was to be rubbed into the skin until it was no longer visible. Patients were encouraged to wash their hands before and after applying cream. The application site was not occluded. The next morning, 6 to 10 hours after initial application, the treated area was washed with mild soap and water to remove any residual cream.
12056362|NCT00142454|Biological|NY-ESO-1 protein|NY-ESO-1 protein was injected intradermally by a study physician or nurse at a dose of 100 μg into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
12056363|NCT00142441|Device|Pulsed dye laser|
12056364|NCT00142428|Drug|Cetuximab|The initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks.
12056365|NCT00142415|Drug|111-In-DOTA-cG250|On Day 1, each subject received a single intravenous (IV) infusion of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
12056366|NCT00142415|Drug|177-Lu-DOTA-cG250|On Day 8, 9, or 10, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m^2 in the initial cohort.
12056367|NCT00142402|Drug|Modafinil|
12056368|NCT00142389|Biological|pneumococcal polysaccharide and protein conjugate vaccines|
12056369|NCT00142350|Drug|continuous infusion of 5-fluorouracil|
12056370|NCT00142350|Drug|combination of irinotecan and cisplatin|
12056371|NCT00142350|Drug|oral administration of S-1|
12056372|NCT00142337|Drug|Zidovudine (ZDV)|Zidovudine 300 mg, twice daily, for one month postpartum. Note: after July 03, 2005, all women received 200 mg, twice daily, for the same duration.
12056373|NCT00142337|Drug|Didanosine (ddI)|250 mg ddI-EC (400 mg if body weight >60 kg) once daily, starting at the onset of labor and for one month postpartum
12056374|NCT00142324|Drug|Donepezil|
12056375|NCT00142298|Drug|Telbivudine (LdT)|Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.
12056376|NCT00142285|Drug|Zinc sulphate (20 mg)|
12056377|NCT00142272|Drug|Ciprofloxacin|
12056378|NCT00142259|Device|Deep brain stimulation of the internal globus pallidus|
12056379|NCT00142246|Drug|Intermittent preventive treatment (SP and amodiaquine)|Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.
12056380|NCT00142246|Other|Placebo|Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age
12056381|NCT00142233|Dietary Supplement|ANTOX (vers.)1.2|"300 µg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine per day (for patients of 10 years and older)
~150 µg organic selenium, 360 mg vitamin C, 114 mg vitamin E, 1440 mg methionine per day (for patients aged between 5 and 9 years)"
12056382|NCT00142233|Drug|Magnesium|"15 mmol per day (for patients of 10 years and older)
~7,5 mmol per day (for patients aged between 5 and 9 years)"
12056383|NCT00142233|Other|Placebo ANTOX (vers)1.2|Placebo ANTOX (vers)1.2
12056384|NCT00142233|Other|Placebo Magnesiocard (2.5 mmol)|Placebo Magnesiocard (2.5 mmol)
12056387|NCT00142207|Device|Insecticide-treated mosquito bed net|Insecticide-treated mosquito bed net
12056388|NCT00142181|Drug|Campath-1H|Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.
12056389|NCT00142168|Drug|CC-5103 (lenalidomide)|Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide)
12056390|NCT00142168|Drug|Rituximab|Begins on week 2 of treatment and is given intravenously once a week for 4 weeks
12056391|NCT00142155|Drug|Rituximab|
12056392|NCT00142155|Drug|monoclonal antibodies|
12056393|NCT00142129|Drug|Bortezomib (Velcade)|
12056394|NCT00142116|Drug|Thalidomide|200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
12056395|NCT00142116|Drug|Rituximab|Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
12056396|NCT00142103|Drug|CPG10101|CPG10101 subcutaneous, 0.20mg/kg, weekly, 12wks
12056397|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks
12056398|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Ribavirin, oral, 800-1400mg, daily, 12wks
12056399|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
12056400|NCT00142103|Drug|Control|Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
12056401|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
12056402|NCT00142090|Drug|3% Hypertonic saline|
12056403|NCT00142090|Drug|Placebo|Normal saline
12056404|NCT00142077|Device|Electronic health record and messaging system|
12056405|NCT00142064|Behavioral|observed levels of pain|
12056406|NCT00142051|Drug|nitric oxide|80 ppm 8 hrs, 40 ppm 8 hrs, 20 ppm 4 hrs, 10 ppm 4 hrs
12056407|NCT00142051|Drug|oxygen|oxygen fi02 21% (room air)
12056408|NCT00142038|Drug|Docetaxel|
12056409|NCT00142038|Drug|Capecitabine|
12056410|NCT00142025|Drug|Oxcarbazepine|
12056411|NCT00142012|Behavioral|Nutrition Intervention|
12056412|NCT00141999|Biological|hepatitis B vaccine|
12056413|NCT00141986|Dietary Supplement|vitamin D3|2000 IU per day
12056414|NCT00141986|Dietary Supplement|vitamin D3|400 IU per os once daily
12056415|NCT00141960|Drug|Famotidine|
12056416|NCT00141947|Drug|bexarotene (Targretin)|
12056417|NCT00141934|Drug|AD 452|
12056418|NCT00141921|Drug|Etanercept|Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection
12056419|NCT00141908|Drug|17-alpha Hydroxyprogesterone Caproate|250 mg IM weekly
12056420|NCT00141908|Drug|Castor oil|weekly IM injections
12056421|NCT00141895|Drug|Misoprostol|2 tablets 200 micrograms Vaginal route
12056422|NCT00141895|Drug|Misoprostol|2 tablets of 200 micrograms Sublingual route
12056423|NCT00141882|Drug|memantine|
12056424|NCT00141856|Behavioral|Telephone care|
12056425|NCT00141843|Genetic|ReFacto AF|
12056426|NCT00141843|Genetic|B-Domain deleted Recombinant Factor VIII|
12056427|NCT00141843|Genetic|BDDrFVIII|
12056428|NCT00141830|Drug|Methotrexate plus ERB-041 for 12 weeks|
12056429|NCT00141830|Drug|Placebo for 12 weeks|
12056430|NCT00141817|Drug|pantoprazole for approximately 9 weeks.|
12056431|NCT00141804|Drug|Sirolimus|
12056432|NCT00141791|Drug|Etanercept|
12056433|NCT00141778|Drug|Placebo|Matching placebo taken once a day
12056434|NCT00141778|Drug|Ramipril|Taken orally, once a day
12056435|NCT00141778|Drug|Spironolactone|Taken orally, once a day
12056436|NCT00141765|Procedure|Myeloablative Chemotherapy|High dose chemotherapy (carboplatin and thiotepa) transplant rescue
12056437|NCT00141765|Procedure|Stem Cell Rescue|autologous stem cell transplantation
12056438|NCT00141752|Device|Toronto Bedside Swallowing Screening Test (TOR-BSST)|Toronto Bedside Swallowing Screening Test
12056439|NCT00141739|Drug|Etanercept|"Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
12056440|NCT00141726|Drug|Etanercept|Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
12056441|NCT00141713|Drug|Etanercept|Patients enrolled on the study will receive etanercept at 0.4 mg/kg per dose up to a maximum of 25 mg per dose subcutaneously twice a week. Etanercept must be initiated within 72 hours of starting solumedrol.
12056442|NCT00141700|Drug|Rituximab|
12056443|NCT00141687|Procedure|Early ECV between 34 0/7 and 35 6/7 weeks|Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation
12056444|NCT00141687|Procedure|Delayed ECV at or after 37 0/7 weeks|Delayed external cephalic version at or after 37 0/7 weeks of gestation
12056445|NCT00141674|Procedure|Blood Transfusion|This is a single centre randomized trial in severely head injured patients requiring a blood transfusion. Randomization will be by computer generated random numbers paced in sealed envelopes. Patients would be randomized to receive either blood less than 5 days old or greater than 20 days old. The decision to transfuse and all other intensive care management will be unaltered by enrolment in the study.
12056446|NCT00141661|Drug|PF-04494700 - Low Dose Arm|30 mg loading dose for 6 days, followed by 10 mg daily
12056447|NCT00141661|Drug|PF-04494700 - High Dose Arm|60 mg loading dose for 6 days, followed by 20 mg daily
12056448|NCT00141661|Drug|Placebo Comparator|Matching placebo.
12056449|NCT00141648|Drug|Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.|Given intravenously on days 1,11,43: Cyclophosphamide 750mg/m2, doxorubicin 50mg/m2, vincristine 1.4mg/m2. Given orally on days 1-5,22-27: Pednisolone 50mg/m2
12056450|NCT00141648|Radiation|Radiotherapy|Total 45 Gy in 25 fractions
12056451|NCT00141635|Behavioral|physio,pain,psychotherapy;social,nutrit.counselling&sports|
12056452|NCT00141622|Drug|Slow sodium|
12056453|NCT00141609|Drug|Slow Sodium|
12056454|NCT00141596|Drug|Cardura XL 4 mg bd|
12056455|NCT00141596|Drug|Amiloride 5 mg bd|
12056456|NCT00141596|Drug|Furosemide 40 mg bd|
12056457|NCT00141583|Drug|Enalapril 20 mg bd|
12056458|NCT00141583|Drug|Candesartan 8 mg bd|
12056459|NCT00141570|Drug|esterified estrogens 0.625 mg and methyltestosterone 1.25 mg|
12056460|NCT00141557|Drug|esterified estrogens 1.25mg and methyltestosterone 2.5mg|ESTRATEST® administered orally QD
12056461|NCT00141557|Drug|Esterified estrogens 1.25 mg|Esterified estrogens 1.25 mg administered orally QD
12056462|NCT00141544|Drug|esterified estrogens 1.25 mg and methyltestosterone 2.5 mg|ESTRATEST® administered orally QD
12056463|NCT00141544|Drug|Esterified estrogens 1.25 mg|Esterified estrogens 1.25 mg administered orally QD
12056464|NCT00141531|Drug|Apaziquone|"Apaziquone (EOquinTM) 4 mg/40 mL was administered by intravesical instillation once a week for 6 consecutive weeks.
~In addition, patients with CIS were to receive further maintenance therapy of 3 weekly apaziquone (EOquinTM) instillations at 3, 6, and 12 months from the date of histological diagnosis."
12056465|NCT00141518|Drug|Levodopa-carbidopa intestinal gel (LCIG)|
12056466|NCT00141518|Device|CADD-Legacy® 1400 ambulatory infusion pump|
12056467|NCT00141518|Device|percutaneous endoscopic gastrostomy tube (PEG tube)|
12056468|NCT00141518|Device|jejunal extension tube (J-tube)|
12056469|NCT00141505|Drug|Bifeprunox|
12056470|NCT00141492|Drug|Androgel (testosterone gel)|
12056471|NCT00141479|Drug|Bifeprunox|
12056472|NCT00141466|Behavioral|Education for professionals|
12056473|NCT00141466|Behavioral|Distribution of educational materials|
12056474|NCT00141466|Behavioral|Feedback for professionals|
12056475|NCT00141466|Behavioral|Reminders for professionals|
12056476|NCT00141453|Drug|olmesartan medoxomil|Tablets 10, 20, or 40 mg
12056477|NCT00141453|Drug|Placebo Tablets|Matching placebo tablets
12056478|NCT00141440|Procedure|mechanical ventilation|evaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease
12056479|NCT00141427|Drug|Pregabalin|
12056480|NCT00141414|Drug|Pregabalin|
12056481|NCT00141401|Drug|Pregabalin|
12056482|NCT00141388|Drug|Pregabalin|
12056483|NCT00141375|Drug|Pregabalin|
12056484|NCT00141362|Drug|Pregabalin|
12056485|NCT00141349|Drug|UK-369,003|
12056486|NCT00141336|Drug|Pregabalin|
12056487|NCT00141323|Drug|lasofoxifene|0.5 mg once per day, orally
12056488|NCT00141323|Other|placebo|placebo
12056489|NCT00141323|Drug|lasofoxifene|0.25 mg once per day, orally
12056490|NCT00141310|Drug|Sildenafil citrate|
12056491|NCT00141297|Drug|PD-0332991|Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2) 2/1 Schedule - PD-0332991 administered days 1-14 of a 21-days schedule, doses ranging from 100 to 225 mg once daily
12056492|NCT00141284|Drug|nelfinavir 1,250 mg twice daily|
12056493|NCT00141284|Drug|Zidovudine 300 mg twice daily|
12056494|NCT00141284|Drug|Lamivudine 150 mg twice daily|
12056495|NCT00141271|Drug|Geodon (Ziprasidone)|Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial
12056496|NCT00141271|Drug|Geodon (Ziprasidone)|Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial
12056497|NCT00141271|Drug|Placebo|Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial
12056498|NCT00141258|Drug|pregabalin|
12056499|NCT00141245|Drug|Pregabalin|
12056500|NCT00141232|Drug|Atorvastatin and Omega-3 fatty acids|
12056501|NCT00141219|Drug|pregabalin|150-600mg/day, BID
12056502|NCT00141219|Drug|Placebo|Placebo
12056503|NCT00141206|Drug|varenicline (CP-526,555)|
12056504|NCT00141193|Drug|Celecoxib|
12056505|NCT00141180|Drug|CP-481,715|
12056506|NCT00141167|Drug|varenicline|
12056507|NCT00141154|Drug|Celecoxib|
12056508|NCT00141154|Drug|Placebo|
12056509|NCT00141154|Drug|Loxoprofen|
12056510|NCT00141141|Drug|Atorvastatin|
12056511|NCT00141141|Drug|Simvastatin|
12056512|NCT00141128|Drug|SS-RBX|
12056513|NCT00141115|Drug|levetiracetam|Levetiracetam 1500 mg BID
12056514|NCT00141102|Drug|Celecoxib|Participants are assigned to one of two groups in parallel for the duration of the study
12056515|NCT00141102|Drug|Diclofenac + Omeprazole|Participants are assigned to one of two groups in parallel for the duration of the study
12056516|NCT00141089|Drug|Tegaserod|
12056517|NCT00141076|Behavioral|low vs high glycemic index diet|
12056518|NCT00141063|Drug|Focalin XR|
12056519|NCT00141050|Drug|Focalin XR|
12056520|NCT00141037|Drug|Daclizumab|"Steroid-Based Immunosuppression(Prednisone) arm: 1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8 (e.g., standard dose of daclizumab induction until the second month post-transplant)
~Steroid-Free Immunosuppression (Extended daclizumab induction) arm: 2 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11, and months 4, 5, and 6 (e.g., extended daclizumab induction until the sixth month post-transplant)"
12056521|NCT00141037|Drug|Mycophenolate mofetil (MMF)|Intravenous MMF was dosed at 1200 mg/m^2/day in two divided doses preoperatively and for the first 48 hours postoperatively. Oral MMF was dosed at 600 to 900 mg/m^2/day in two divided doses; the dose range allowed for dose titration according to tolerability and side effects of MMF. This regimen was used in both arms.
12056579|NCT00140556|Radiation|Chemoradiotherapy|External beam radiation daily (M-F)
12056580|NCT00140556|Drug|Cisplatin|Cisplatin week 1 and 5 of radiation
12056581|NCT00140556|Drug|Bevacizumab|Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation
12056522|NCT00141037|Drug|Prednisone|Administered as 10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40 kg and 1.5 mg/kg/day in subjects weighing >40 kg. The prednisone dosing was tapered as follows: by the end of wks 1, 2, 4,6,12 and 16, dosages were 0.5, 0.4, 0.3, 0.2, 0.15 and 0.1 mg/kg/day, respectively. The prednisone dose of 0.1 mg/kg was achieved by no later than 6 months post-transplant.
12056523|NCT00141037|Drug|Tacrolimus|Taken orally from immediately preoperatively to those>age 5 yrs. (starting dose= 0.1 mg/kg/dose twice daily (BID) for living donor recipients; 0.1 mg/kg/dose daily for deceased donor recipients).Subjects <age 5 yrs. received drug from immediately preoperatively at 0.15 mg/kg/dose BID (two preoperative doses) for living donor recipients and 0.15 mg/kg/dose daily (one preoperative dose) for deceased donor recipients. Postoperatively: 0.07 mg/kg/dose BID w/adjustment to achieve target levels of 12-14 ng/mL (days 0-7), 10-12 ng/mL (wks. 2-8), 7-10 ng/mL (wks. 9-12) &5-7 ng/mL >= 12 wks. Evidence of drug toxicity on any protocol biopsy resulted in a further lowering of the drug target level to 4-6 ng/mL before yr 1 & 3-5 ng/mL after yr 1 post-transplant. This regimen was used in both arms.
12056524|NCT00141037|Drug|Ganciclovir|Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Prophylaxis: All participants will receive intravenous ganciclovir 5 mg/kg/day beginning after transplantation until tolerating oral medications, at which time oral valganciclovir will be initiated and continued for a minimum of 100 days.
12056525|NCT00141037|Drug|Valganciclovir|Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Prophylaxis: All participants will receive intravenous ganciclovir 5 mg/kg/day beginning after transplantation until tolerating oral medications, at which time oral valganciclovir will be initiated and continued for a minimum of 100 days.
12056526|NCT00141037|Drug|Trimethoprim and sulfamethoxazole|Pneumocystis pneumonia (PCP)/Urinary Tract Infection (UTI) Prophylaxis: Trimethoprim/sulfamethoxazole (Septra®) 2 mg/kg by mouth will be administered daily at bedtime for a minimum period of the first 6 months post-transplant. If unable to tolerate Septra®, inhaled pentamidine (8 mg/kg to a maximum dose of 300 mg monthly) or Dapsone (2 mg/kg PO to a maximum dose of 100 mg/day) may be substituted for a minimum of the first 6 months post-transplant. For UTI prophylaxis, if Septra® is not tolerated, nitrofurantoin (Macrodantin®), 2.5 mg/kg/day, may be given at bedtime up to a maximum dose of 100 mg/day.
12056527|NCT00141024|Biological|EP HIV-1043|"Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
~The vaccine is provided in single-use 1.1-mL vials."
12056528|NCT00141024|Biological|EP HIV-1090|DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
12056529|NCT00141011|Drug|Ancrod (Viprinex)|0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
12056530|NCT00141011|Drug|Placebo|0.6 mL/kg/hr
12056531|NCT00140998|Drug|17 beta estradiol|
12056532|NCT00140985|Drug|MK0954, losartan potassium/Duration of Treatment: 20 weeks|
12056533|NCT00140985|Drug|Comparator: amlodipine / Duration of Treatment: 20 weeks|
12056534|NCT00140972|Drug|MK0663; etoricoxib / Duration of Treatment:4 Weeks|
12056535|NCT00140972|Drug|Comparator: diclofenac sodium tablet 75 mg / Duration of Treatment:4 Weeks|
12056536|NCT00140959|Drug|MK0954, losartan potassium/Duration of Treatment: 18 weeks|
12056537|NCT00140959|Drug|Comparator: losartan, HCTZ, amlodipine, atenolol/Duration of Treatment: 18 weeks|
12056538|NCT00140946|Drug|MK0476; montelukast sodium/Duration of Treatment: 16 weeks|
12056539|NCT00140946|Drug|Comparator: placebo / Duration of Treatment: 16 weeks|
12056540|NCT00140933|Drug|MK0966; rofecoxib|
12056541|NCT00140933|Drug|Comparator: diclofenac, placebo|
12056542|NCT00140920|Drug|MK0966; rofecoxib|
12056543|NCT00140920|Drug|Comparator: diclofenac 2x 75 mg|
12056544|NCT00140907|Drug|losartan potassium|25 mg of oral losartan once daily, with an up-titration to 50 mg of losartan once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.
12056545|NCT00140907|Drug|Comparator: Placebo|25 mg of oral placebo once daily, with an up-titration to 50 mg placebo once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.
12056546|NCT00140894|Drug|MK0966; rofecoxib / Duration of Treatment: 24 weeks|
12056547|NCT00140894|Drug|Comparator: placebo / Duration of Treatment: 24 weeks|
12056548|NCT00140881|Drug|MK0476; montelukast sodium|
12056549|NCT00140881|Drug|Comparator: placebo|
12056550|NCT00140868|Device|Luminal stents|
12056551|NCT00140868|Procedure|Minimally Invasive Surgical Bowel Diversion|
12056552|NCT00140855|Drug|Anti-CTLA4 (monoclonal antibody MDX-010)|
12056553|NCT00140816|Behavioral|Increased intake of dairy products|
12056554|NCT00140803|Drug|Visudyne|
12056555|NCT00140803|Drug|Kenalog|
12056556|NCT00140790|Drug|valsartan|valsartan 40 or 160 (80) mg per day
12056557|NCT00140764|Drug|Metronidazole gel versus placebo gel|
12056558|NCT00140751|Drug|Lopinavir/ritonavir (drug)|
12056559|NCT00140738|Biological|GSK Biologicals' 719125|Patients receive six vaccinations at two-week intervals
12056560|NCT00140725|Drug|Lamivudine plus Polyethylene glyco-interferon alfa-2b|
12056561|NCT00140725|Drug|Lamivudine|
12056562|NCT00140712|Drug|Ropinirole Immediate Release|Ropinirole Immediate Release
12056563|NCT00140699|Behavioral|Balance|
12056564|NCT00140686|Biological|Rotavirus (vaccine)|
12056565|NCT00140673|Biological|Rotavirus|
12056566|NCT00140660|Drug|rituximab|375 mg/m2 on D1
12056567|NCT00140647|Drug|Ramipril|
12056568|NCT00140647|Drug|Rosiglitazone|
12056569|NCT00140634|Biological|Carticel (autologous cultured chondrocyte) implantation|Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap.
12056570|NCT00140621|Drug|Agalsidase beta|
12056571|NCT00140608|Device|Seprapack Sinus Dressing|
12056572|NCT00140595|Drug|rituximab|
12056573|NCT00140595|Drug|doxorubicin|
12056574|NCT00140595|Drug|cyclophosphamide|
12056575|NCT00140582|Drug|Rituximab|rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
12056576|NCT00140569|Procedure|CHVP + interferon|
12056577|NCT00140569|Drug|fludarabine|
12056578|NCT00140569|Procedure|CHOP + TBI and autotransplant|
12056582|NCT00140556|Drug|Erlotinib|Erlotinib daily during radiation
12056583|NCT00140543|Drug|sirolimus versus mycophenolate mofetil|
12056584|NCT00140530|Device|Paclitaxel-eluting stent (Taxus)|patients has been implanted the Paclitaxel-eluting stent.
12056585|NCT00140530|Device|Rapamycin-eluting stent|patients has been implanted the Rapamycin-eluting stent.
12056586|NCT00140517|Drug|sulphadoxine-pyrimethamine|
12056587|NCT00140517|Drug|chloroquine|
12056588|NCT00140504|Other|Medcheck message|Participants selected at random will receive one email message asking them questions about their prescription which will be forwarded to their physician
12056589|NCT00140491|Device|Vision Restoration Therapy (NOVAVISION)|
12056590|NCT00140478|Drug|Mifepristone|200mg orally once daily
12056591|NCT00140465|Drug|Clopidogrel|after PCI
12056592|NCT00140465|Drug|Clopidogrel|after PCI
12056593|NCT00140452|Drug|Thalidomide|Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day.
12056594|NCT00140439|Behavioral|Emergency Department based asthma follow-up clinic|"The clinical activities of the intervention followed a fully specified protocol and provided education and care in three domains:
~Asthma self-monitoring and management: Educators first reviewed the basic physiology of asthma with emphasis on its chronicity. After evaluating asthma severity and treatment history, the physician completed an individualized medical action plan (MAP) and provided any necessary device teaching.
~Environmental modification and trigger control: After evaluation of potential environmental triggers in the home, each family was educated on their control. Each child was provided hypoallergenic bed encasings.
~Linkages and referrals to ongoing primary care: Clinic staff stressed the importance of longitudinal asthma care by a PCP. A full report of the clinic visit was mailed to each child's PCP. In addition, the asthma educator scheduled a follow-up appointment with the PCP within 4 weeks"
12056595|NCT00140426|Drug|Risperidone|risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
12056596|NCT00140426|Drug|Placebo|Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.
12056597|NCT00140413|Drug|Nutropin AQ|Daily injection. Dosage dependent on weight.
12056598|NCT00140400|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
12056599|NCT00140387|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
12056600|NCT00140374|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
12056601|NCT00140361|Drug|Sulfadoxine-pyrimethamine|
12056602|NCT00140361|Drug|sulfadoxine-pyrimethamine plus artesunate|
12056603|NCT00140361|Drug|lumefantrine plus artemether|
12056604|NCT00140361|Behavioral|Sleeping under insecticide-treated bednet|
12056605|NCT00140348|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
12056606|NCT00140335|Behavioral|handwashing|
12056607|NCT00140322|Behavioral|Exercise, fall risk reduction|
12056608|NCT00140309|Drug|moxifloxacin (with isoniazid, rifampin, pyrazinamide)|
12056609|NCT00140296|Behavioral|Contraceptive counseling|
12056610|NCT00140283|Procedure|Educational interactive intervention|
12056611|NCT00140270|Behavioral|PEP program|
12056612|NCT00140257|Drug|Escitalopram|
12056613|NCT00140244|Drug|r-metHuLeptin|
12056614|NCT00140244|Drug|Placebo|
12056615|NCT00140231|Drug|r-metHuLeptin|recombinant human leptin
12056616|NCT00140231|Other|placebo|placebo (no active drug)
12056617|NCT00140218|Drug|R(+) pramipexole dihydrochloride monohydrate|10 mg tid oral
12056618|NCT00140205|Drug|r-metHuLeptin|r-metreleptin was given in 3 different dose in fed and fasting states
12056619|NCT00140192|Drug|creatine|
12056620|NCT00140179|Drug|valnoctamide|
12056621|NCT00140166|Drug|niacinamide|
12056622|NCT00140166|Drug|pyridoxine|
12056623|NCT00140166|Drug|ascorbate|
12056624|NCT00140153|Drug|testosterone gel (Androgel)|
12056625|NCT00140140|Drug|ABI-007|Weekly intravenous infusions over 30 minutes.
12056626|NCT00140140|Drug|vinorelbine|Weekly intravenous infusions over 10-30 minutes, immediately after ABI-007. Vinorelbine is commercially available and was not supplied by the Sponsor.
12056627|NCT00140140|Drug|Trastuzumab|"Trastuzumab was administered to participants who had HER-2-neu positive tumors. Participants received trastuzumab by IV infusion via a vascular access device following dosing with ABI-007 and vinorelbine. During their first cycle, 4 mg/kg was administered on day 1 of that cycle as a loading dose. During subsequent weekly treatments, 2 mg/kg was administered.
~Trastuzumab is commercially available and was not supplied by the Sponsor."
12056628|NCT00140140|Biological|G-CSF|"During Part 1, participants followed a dosing regimen with ABI-007 and vinorelbine without G-CSF treatment. However, G-CSF was allowed for administration as necessary in accordance with commonly accepted clinical guidelines.
~In Part 2, participants started G-CSF treatment in concurrence with their ABI-007 and vinorelbine treatments. G-CSF was administered to all participants on Days 2-7 of each cycle, at a dose of 5 mcg/kg. If the participant's absolute neutrophil (ANC) count was >20,000/mm^3 on the day of anticipated chemotherapy, the site staff reduced the daily dose of G-CSF by 50% to 2.5 mcg/kg.
~G-CSF is commercially available and was not supplied by the Sponsor."
12056629|NCT00140114|Drug|Misoprostol (Cytotec®)|50 micrograms of sublingual or vaginal misoprostol every 4 hours for a maximum of 5 doses
12056630|NCT00140101|Device|ZoMaxx™ Drug-Eluting Coronary Stent System|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12056631|NCT00140101|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
12056632|NCT00140088|Drug|ALGRX 3268|
12056633|NCT00140075|Drug|Epirubicin with Cyclophosphamide, followed by a Taxane|"Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2
~Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2"
12056634|NCT00140075|Drug|Epirubicin with a Taxane|"Epirubicin = 75 mg/m2 per cycle
~Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2"
12056635|NCT00140062|Drug|latanoprost 0.005% (Xalatan)|
12056636|NCT00140049|Drug|Xalacom|
12056637|NCT00140049|Drug|Cosopt|
12056638|NCT00140036|Procedure|Blood draw|
12056639|NCT00140023|Drug|Azithromycin microspheres 2.0 single dose|
12056640|NCT00140010|Drug|erythropoietin beta|30,000 units in 6 mL of 0.9% saline IV for 15 minutes every other day for 3 doses within 72 hours after aneurysmal subarachnoid hemorrhage
12056641|NCT00139997|Device|Litebook treatment devices|Litebook LED phototherapy device used for 30 min before 8 am
12056642|NCT00139997|Device|Inactivated negative ion generator|Equivalent exposure to inactivated negative ion generator
12056643|NCT00139984|Device|24 hour blood pressure measurement|
12056644|NCT00139971|Drug|gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6|
12056645|NCT00139971|Drug|UFT 250mg/m2, daily for 1 year|
12056646|NCT00139945|Drug|Human acylated ghrelin|5 pmol/kg body weight per min
12056647|NCT00139932|Drug|formoterol fumarate|
12056648|NCT00139919|Drug|Bifeprunox|
12056649|NCT00139906|Drug|Bifeprunox|
12056650|NCT00139893|Drug|Reglan ODT|
12056651|NCT00139880|Drug|Parcopa|
12056652|NCT00139867|Drug|PARCOPA|
12056653|NCT00139854|Drug|Alprazolam orally disintegrating tablets|
12056654|NCT00139841|Drug|Bendamustine HCl|Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.
12056655|NCT00139828|Drug|human coagulation Factor IX|
12056656|NCT00139815|Drug|Fondaparinux|fondaparinux 2.5 mg, s.c. injection once daily x 8 days or Hospital Discharge if earlier and placebo-enoxaparin 1mg/kg s.c. injection twice daily x 2-8 days or until clinically stable
12056657|NCT00139815|Drug|enoxaparin|enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days
12056658|NCT00139802|Device|Coronary Stent Implantation|
12056659|NCT00139789|Drug|Kemstro|
12056660|NCT00139776|Drug|Celecoxib|"24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily.
~Placebo used as flare medication when directed."
12056661|NCT00139776|Drug|Celecoxib|"24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily.
~Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed."
12056662|NCT00139763|Procedure|Educational Materials|
12056663|NCT00139750|Drug|CP-526,555 (varenicline)|
12056664|NCT00139737|Drug|Ziprasidone|20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
12056665|NCT00139724|Drug|tolterodine extended release capsule|
12056666|NCT00139711|Drug|Irinotecan|
12056667|NCT00139711|Drug|Docetaxel|
12056668|NCT00139698|Drug|olmesartan alone or in combination with hydrochlorothiazide|
12056669|NCT00139685|Drug|Depo-Provera Contraceptive Injection - DP150CI|
12056670|NCT00139672|Drug|PD-217,014|
12056671|NCT00139659|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
12056672|NCT00139659|Drug|Subcutaneous Insulin|Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
12056673|NCT00139646|Drug|Parecoxib|
12056674|NCT00139646|Drug|Diclofenac|
12056675|NCT00139633|Drug|carboplatin, 5FU, Taxol and radiation|
12056676|NCT00139620|Drug|Tarceva, erlotinib, OSI-774|
12056677|NCT00139607|Drug|Paracoxib|
12056678|NCT00139594|Drug|licarbazepine|
12056679|NCT00139581|Drug|Pimecrolimus|Pimecrolimus cream 1 % applied twice daily (b.i.d.)
12056680|NCT00139581|Drug|Pimecrolimus|Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
12056681|NCT00139568|Drug|Tegaserod|
12056682|NCT00139555|Drug|amlodipine/benazepril|
12056683|NCT00139542|Other|One shock per minute AED protocol|Single shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery.
12056684|NCT00139542|Other|Guidelines 2000 AED protocol|Up to 3 consecutive shocks in a stack; No initial CPR prior to the first shock; Post-shock pulse checks after each non-shockable rhythm analysis; 60 sec CPR after each non-shockable rhythm analysis.
12056685|NCT00139529|Behavioral|Motivational Interviewing Telephone Counseling|Participants will receive up to 5 phone calls.
12056686|NCT00139529|Behavioral|Educational Intervention|Educational intervention will be completed during pregnancy.
12056687|NCT00139516|Behavioral|self-help|
12056688|NCT00139516|Drug|nicotine replacement therapy|
12056689|NCT00139516|Behavioral|smoking cessation|
12056690|NCT00139490|Behavioral|Health Education Program|The augmented intervention will consist of just-in-time nurse, patient and physician information and feedback during the post-acute period, plus transition to an ongoing Home-Based HTN Support Program within approximately 30 days after the patient's admission to home health care. The augmented intervention adds an HTN Nurse Specialist (advanced practice nurse) and a lay community health worker, who will be responsible for assuring a patient's smooth transition to the Home-Based HTN Support Program and for delivering the main components of that intervention, backed up by the project physician.
12056691|NCT00139490|Behavioral|Basic Group|"The basic information and referral intervention will deliver key just-in-time information to nurses, patients and patients' physicians while the patient is receiving post-acute home care services. The basic intervention relies on care provided by home health nurses during the routine home health stay."
12056692|NCT00139490|Behavioral|Control Group|Usual Care
12056693|NCT00139477|Drug|Metformin|Metformin, 250mg by mouth twice a day with meals will be started and if tolerated increased to 500mg twice a day in 3 days in those less than 12 years old and titrated further to 1000mg twice a day if tolerated.
12056694|NCT00139477|Behavioral|Dietary modification with caloric restriction|The life style intervention changes will include a hypocaloric diet representing at least a 500 kcal/day reduction based on their dietary histories and Resting Energy Expenditure (REE) determined by the initial calorimetry.
12056771|NCT00138736|Drug|Mannan Binding Lectin|"MBL dose at a twice weekly dose interval (3 or 4 days):
~0.2 mg/kg, for a 3-day interval; 0.3 mg/kg, for a 4-day interval"
12056695|NCT00139477|Behavioral|Establishment of exercise protocol|Participants will attend the Fitness Center 3 times per week and supervised by an exercise technician or exercise specialist. Exercise will be individually prescribed for each participant based on their functional abilities. Exercise will consist of 5-10 minutes for warm up and stretching, followed by 15-30 minutes of cardiovascular exercise (i.e. treadmill, bicycle ergometer, rower, nustep, etc), 10-20 minutes of strength training (supervised using weight stack equipment), and 5-10 minutes of cool down and stretching. As children typically do not need an exercise prescription based on heart rate, we will familiarize them with perceived exertion scales and monitor that they are exercising in the moderate to hard range of perception of effort. Participants will be started at 15 minutes of cardiovascular exercise and 10 minutes of strength training exercise, progressing by 2-3 minutes every week until 30 and 20 minutes is achieved for each respectively.
12056696|NCT00139451|Drug|Pediasure|With the assistance of a research dietician, we will prescribe and monitor the use of a liquid food supplement (Pediasure). Adjustments to the supplementation will be made based on weight measurements in the clinic with subjects wearing paper gowns at 2 and 4w, and monthly thereafter, and repeat dietary intake and TEE assessment at 6 and 12mo.
12056697|NCT00139451|Drug|GH|Growth Hormone will be 0.3mg/kg/week, given SC once daily.
12056698|NCT00139438|Behavioral|Disease Management Assessment|
12056699|NCT00139425|Behavioral|Disease Management Assessment|
12056700|NCT00139399|Procedure|Coronary artery bypass graft (CABG) surgery|Patients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery
12056701|NCT00139386|Drug|Candesartan|Candesartan Cilexetil (4-12 mg per day)
12056702|NCT00139373|Drug|donepezil|
12056703|NCT00139360|Drug|Bevacizumab|Anti angiogenesis treatment
12056704|NCT00139347|Biological|2-dose oral live attenuated G1P[8] human rotavirus vaccine|
12056705|NCT00139334|Biological|Rotavirus|
12056706|NCT00139321|Device|Force platform and electromyography|
12056707|NCT00139308|Device|high frequency stimulation|
12056708|NCT00139295|Device|Hylastan|
12056709|NCT00139282|Drug|Squalamine Lactate|
12056710|NCT00139269|Drug|Docetaxel|
12056711|NCT00139269|Drug|Cisplatin|
12056712|NCT00139269|Drug|5-Fluorouracil|
12056713|NCT00139256|Drug|Betamethasone|Betamethasone injection
12056714|NCT00139243|Drug|Taxotere|
12056715|NCT00139243|Drug|Cisplatin|
12056716|NCT00139243|Drug|5-Fluorouracil|
12056717|NCT00139243|Drug|Leucovorin|
12056718|NCT00139230|Drug|Taxotere|
12056719|NCT00139230|Drug|Cisplatin|
12056720|NCT00139230|Drug|5-Fluorouracil|
12056721|NCT00139230|Drug|Leucovorin|
12056722|NCT00139230|Drug|G-CSF|
12056723|NCT00139230|Drug|Ciprofloxacin|
12056724|NCT00139217|Drug|iNO|
12056725|NCT00139217|Procedure|Non-invasive nitric oxide|
12056726|NCT00139204|Procedure|C11 Methionine PET scan|
12056727|NCT00139191|Procedure|C-11 acetate PET scan|
12056728|NCT00139178|Drug|Different HAART regimens|
12056729|NCT00139165|Drug|Budesonide|Capsule. Oral 6 mg o.d. for 24 weeks
12056730|NCT00139165|Procedure|sigmoidoscopy|Sigmoidoscopy performed 2 times during the study period.
12056731|NCT00139152|Drug|Placebo|Saline, Sub-Cuteanous (SQ)
12056732|NCT00139152|Drug|Xolair|Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
12056733|NCT00139139|Biological|Hepatitis A vaccine|
12056734|NCT00139126|Behavioral|Fire safety education|Education on smoke alarm maintenance based on behavioral theories
12056735|NCT00139113|Biological|hepatitis A vaccine|2 doses of inactivated hepatitis A vaccine manufactured by GSK in licensed pediatric formulation of 720 EL. U. per dose given on 3 different schedules: aged 6 and 12 months, 12 and 18 months, and 15 and 21 months. Within each group, subjects were randomized to achieve a relatively equal number of children born to anti-HAV positive and anti-HAV negative mothers.
12056736|NCT00139100|Drug|antimicrobial agent in soap|
12056737|NCT00139087|Behavioral|Telephone Outreach for Therapy|
12056738|NCT00139074|Drug|Quetiapine fumarate|oral variable dose
12056739|NCT00139074|Drug|sodium valproate|oral
12056740|NCT00139061|Drug|Torcetrapib/Atorvastatin|
12056741|NCT00139061|Drug|Fenofibrate|
12056742|NCT00139048|Behavioral|Decision Aid|
12056743|NCT00139035|Drug|cyclosporine A|
12056744|NCT00139022|Device|Continuous Positive Airway Pressure|
12056745|NCT00139009|Drug|Cyclosporine A|
12056746|NCT00138996|Device|automated direct feedback on CPR from defibrillator|
12056747|NCT00138983|Drug|Alendronate versus alfacalcidol (1-alpha OH vitamin D)|
12056748|NCT00138970|Drug|Zenapax®, CellCept® and prednisolone|
12056749|NCT00138970|Drug|Sandimmun Neoral®, CellCept® and prednisolone|
12056750|NCT00138957|Procedure|Laparoscopic parastomal hernia repair with mesh|
12056751|NCT00138944|Drug|placebo|od
12056752|NCT00138944|Drug|eplerenone|50mg od
12056753|NCT00138931|Procedure|Blood draw (genetic testing)|Blood draw (genetic testing)
12056754|NCT00138918|Biological|OGX-011|See Detailed Description, Treatment Plan
12056755|NCT00138905|Device|UMTS mobile basestation radiation|
12056756|NCT00138892|Procedure|Waiting time (access time to Total joint replacement)|See Detailed Description.
12056757|NCT00138866|Drug|Risedronate|
12056758|NCT00138853|Device|Tibial component|Tibial component inserted at the time of surgery
12056759|NCT00138840|Drug|STA-5326 mesylate|
12056760|NCT00138827|Drug|Biotene (mouth care)|
12056761|NCT00138814|Procedure|Radiotherapy (boost versus no boost)|
12056762|NCT00138801|Drug|Ceftriaxone|
12056763|NCT00138801|Drug|Doxycycline|
12056764|NCT00138788|Procedure|Radiotherapy, dose fractionation|
12056765|NCT00138775|Drug|D-serine|
12056766|NCT00138762|Drug|torcetrapib/atorvastatin|
12056767|NCT00138762|Drug|atorvastatin|
12056768|NCT00138762|Drug|placebo|
12056769|NCT00138749|Drug|SS-RBX|
12056770|NCT00138736|Drug|Mannan Binding Lectin (MBL)|
12056775|NCT00138684|Procedure|venesection|Venesection therapy is realised every 7 - 14 days until iron desaturation completion.
12056776|NCT00138671|Drug|Subcutaneous Insulin|Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
12056777|NCT00138671|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
12056778|NCT00138658|Drug|custirsen sodium|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose). OGX 011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused intravenously for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused intravenously on Day 1 of this 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle = 21 days)
12056779|NCT00138645|Behavioral|MicroDiet|MicroDiet
12056780|NCT00138645|Behavioral|Healthy Diet|Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements
12056781|NCT00138632|Drug|PTK787|Visudyne® + PTK787, 500 mg/day
12056782|NCT00138632|Drug|PTK787|Visudyne® + PTK787 1000 mg/day
12056783|NCT00138632|Drug|Placebo|Visudyne® + Placebo
12056784|NCT00138619|Drug|vildagliptin|
12056785|NCT00138606|Drug|vildagliptin|
12056786|NCT00138593|Drug|vildagliptin|
12056787|NCT00138580|Drug|vildagliptin|
12056788|NCT00138567|Drug|vildagliptin|
12056789|NCT00138554|Drug|vildagliptin|
12056790|NCT00138554|Drug|pioglitazone|pioglitazone 45 mg qd
12056791|NCT00138541|Drug|vildagliptin|
12056792|NCT00138528|Drug|Fluvastatin|
12056793|NCT00138515|Drug|vildagliptin|
12056794|NCT00138476|Drug|Placebo|120 mL of the sodium bicarbonate solution, followed by 82 mL of sterile water, United States Pharmacopeia (USP) without virus; followed by 500 mg of sodium bicarbonate aqueous solution taken 5 minutes after placebo inoculation.
12056795|NCT00138476|Biological|Norwalk Virus|Prepared and packaged from liquid feces (DC544) by clarification, centrifugation, and serial dilutions; desired doses [reverse transcription polymerase chain reaction (RT-PCR) Units] 4800, 48, 4.8, 0.48.
12056796|NCT00138424|Drug|Cidofovir|Cidofovir is a marketed product for treatment of Cytomegalovirus disease (retinitis) in human immunodeficiency virus (HIV) infected patients. It is packaged as a sterile, hypertonic aqueous solution for intravenous infusion only. Dosages: 0.25 mg/kg, 0.5 mg/kg, and 1.0 mg/kg.
12056797|NCT00138424|Drug|Placebo|The control for this study is sterile, 0.9% normal saline for intravenous use.
12056798|NCT00138411|Drug|Ciprofloxacin 500 mg|
12056799|NCT00138411|Drug|ETI-204 (Anthim)|
12056800|NCT00138398|Biological|Commercial TriValent Split Influenza Virus|
12056801|NCT00138385|Biological|FluMist|
12056802|NCT00138385|Biological|Fluzone|
12056803|NCT00138359|Drug|Niclosamide|
12056804|NCT00138294|Biological|live attenuated and inactivated influenza vaccines|Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) were administered to eligible children through a research program to improve vaccination coverage in school-aged children. Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) will be offered LAIV or IIV through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received LAIV or IIV from the local healthcare providers
12056805|NCT00138281|Biological|FluMist|
12056806|NCT00138281|Biological|Fluzone|
12056807|NCT00138242|Drug|carboplatin|
12056808|NCT00138242|Drug|docetaxel|
12056809|NCT00138242|Procedure|adjuvant therapy|
12056810|NCT00138229|Biological|aldesleukin|
12056811|NCT00138229|Biological|filgrastim|
12056812|NCT00138229|Biological|therapeutic autologous lymphocytes|
12056813|NCT00138229|Drug|cyclophosphamide|
12056814|NCT00138229|Drug|fludarabine phosphate|
12056815|NCT00138216|Drug|irinotecan hydrochloride|
12056816|NCT00138216|Drug|temozolomide|
12056817|NCT00138216|Drug|vincristine sulfate|
12056818|NCT00138203|Drug|vorinostat|Given PO
12056819|NCT00138203|Other|laboratory biomarker analysis|Correlative studies
12056820|NCT00138177|Drug|oxaliplatin|Given IV
12056821|NCT00138177|Drug|leucovorin calcium|Given IV
12056822|NCT00138177|Drug|vorinostat|Given orally
12056823|NCT00138177|Drug|fluorouracil|Given IV
12056824|NCT00138164|Biological|denileukin diftitox|
12056825|NCT00138151|Biological|recombinant interferon alpha-2b|Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
12056826|NCT00138151|Drug|isotretinoin|Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
12056827|NCT00138151|Drug|paclitaxel|Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
12056828|NCT00138138|Drug|Ritalin|
12056829|NCT00138125|Drug|Faslodex|Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.
12056830|NCT00138125|Biological|Herceptin|Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly
12056831|NCT00138112|Drug|Empirical Vancomycin|
12056832|NCT00138112|Drug|Prophylactic Vancomycin|
12056833|NCT00138099|Drug|Fragmin (dalteparin sodium)|
12056834|NCT00138086|Drug|Zevalin plus BEAM|
12056835|NCT00138073|Device|Web-based waveform interpretation guide|Use of an educational website.
12056836|NCT00138060|Drug|irinotecan|180 mg/m² or 260 mg/m² in 90 minutes every 15 days
12056837|NCT00138060|Drug|5 fluorouracil|400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion
12056838|NCT00138047|Drug|zinc supplementation|
12056909|NCT00137553|Drug|Sulfadoxine-pyrimethamine (Fansidar)|
12056839|NCT00138034|Procedure|Percutaneous coronary intervention (PCI)|PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
12056840|NCT00138021|Device|Computerized cognitive training program|"The cognitive training model used in the McGurk et al. (2005) study is referred to as the Thinking Skills for Work program. The program is a manualized, remediative and compensatory training intervention that is integrated with SE services. The program includes a cognitive trainer, a structured training manual (McGurk & Mueser, unpublished training manual) and a computer-based cognitive training program (described below)."
12056841|NCT00138008|Drug|endocrine therapy|Drug: endocrine therapy
12056842|NCT00138008|Procedure|radiotherapy|Procedure/Surgery: radiotherapy
12056843|NCT00137995|Drug|Rituximab|375 mg/m² D-2/D1
12056844|NCT00137995|Drug|Etoposide|100 mg/m² D1-D2-D3
12056845|NCT00137995|Drug|Carboplatine|max 800mg D2
12056846|NCT00137995|Drug|Ifosfamide + Mesna|5 g/m² from D2 to D13
12056847|NCT00137995|Drug|Cisplatine|100 mg/m² from D1 to D13
12056848|NCT00137995|Drug|Cytosine Arabinoside|2000 mg/m²/12 h D2 D3
12056849|NCT00137995|Drug|Dexamethasone|40 mg From D1 to D4
12056850|NCT00137995|Procedure|Autologous Stem Cell Transplantation|
12056851|NCT00137995|Drug|BCNU|300mg/m² on D-6
12056852|NCT00137995|Drug|Etoposide|200 mg/m² from D-6 to D-3
12056853|NCT00137995|Drug|Cytarabine|100 mg/m² from D-6 to D-3
12056854|NCT00137995|Drug|Melphalan|140 mg/m² on D-2
12056855|NCT00137982|Procedure|Treatment of ectopic pregnancy|
12056856|NCT00137969|Drug|Rituximab|Rituximab will be supplied as a sterile liquid for IV administration.
12056857|NCT00137969|Drug|Placebo|Placebo will be supplied as a sterile liquid for IV administration.
12056858|NCT00137969|Drug|Prednisone|
12056859|NCT00137969|Drug|Acetaminophen|
12056860|NCT00137969|Drug|Diphenhydramine|
12056861|NCT00137956|Device|Emphasys Endobronchial Valve (EBV) Device and Procedure|
12056862|NCT00137943|Behavioral|Full Parent communication intervention|
12056863|NCT00137943|Behavioral|Brief Parent Communication Intervention|
12056864|NCT00137943|Behavioral|Control Parent Intervention|
12056865|NCT00137930|Biological|Live attenuated rotavirus vaccine|
12056866|NCT00137917|Biological|Meningococcal serogroup B vaccine|
12056867|NCT00137891|Drug|Modified Release rhTSH|
12056868|NCT00137878|Drug|TNFerade™|
12056869|NCT00137865|Genetic|EGEN-001 (phIL-12-005/PPC)|
12056870|NCT00137852|Drug|Cisplatin|Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.
12056871|NCT00137852|Drug|Irinotecan|Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
12056872|NCT00137852|Drug|Celecoxib|Given twice daily 3 days prior to radiation and up until one week prior to surgery. It will then be started again once the participant is released from the hospital following surgery for 26 weeks.
12056873|NCT00137852|Procedure|Radiation Therapy|5 days a week for 5-6 weeks
12056874|NCT00137852|Procedure|Esophagectomy|Within 4-8 weeks of chemoradiation therapy
12056875|NCT00137839|Drug|Erlotinib|
12056876|NCT00137826|Drug|Erlotinib|Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.
12056877|NCT00137826|Drug|Bevacizumab|Given intravenously over 30-90 minutes, on day 1 of each 21-day cycle. Participants may continue on study treatment until disease progresses or they experience serious side effects.
12056878|NCT00137813|Drug|Docetaxel|Given intravenously once a week for 3 out of four weeks for a minimum of 8 weeks and maximum of a year and a half
12056879|NCT00137813|Drug|Bevacizumab|Given intravenously once a week for every other week for a minimum of 8 weeks and a maximum of a year and a half
12056880|NCT00137800|Drug|OSI-774 (Tarceva)|Once daily without interruption as long as there is no disease progression or serious side effects experienced.
12056881|NCT00137787|Drug|ciprofloxacin|
12056882|NCT00137787|Drug|cefepime|
12056883|NCT00137774|Drug|Bevacizumab|Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.
12056884|NCT00137774|Drug|Temozolomide|Given once daily for one week followed by a one week rest period. This one-week on/one-week off scheduled will be continued as long as there is no disease progression or serious side effects.
12056885|NCT00137761|Drug|ZD 1839|Taken orally once daily
12056886|NCT00137761|Drug|Docetaxel|Given intravenously once weekly for 2 out of 3 weeks
12056887|NCT00137748|Drug|CMV-Ig|Drug: CMV-Ig
12056888|NCT00137735|Drug|Gabapentin|300mg tds
12056889|NCT00137735|Other|placebo|tds
12056890|NCT00137722|Behavioral|Education of providers and their staff|
12056891|NCT00137722|Behavioral|Case management|
12056892|NCT00137722|Behavioral|Payment for desired behaviors|
12056893|NCT00137709|Drug|Sodium valproate|Week 1 & 2 - 200mg twice daily Week 3 onwards - 400mg twice daily
12056894|NCT00137709|Drug|Lamotrigine|Week 1 - 25mg mane Week 2 - 25mg twice daily Week 3 - 25mg mane, 50mg nocte Week 4 onwards - 50mg twice daily
12056895|NCT00137696|Biological|Vaccination with inactivated polio vaccine|
12056896|NCT00137696|Procedure|Collection of serum|
12056897|NCT00137683|Behavioral|one-on-one education, group education, small media|
12056898|NCT00137670|Device|Video-based HIV/STD prevention intervention|
12056899|NCT00137657|Drug|Cotrimoxazole (trimethoprim sulfamethoxazole)|
12056900|NCT00137644|Behavioral|Preventing AIDS Through Live Movement and Sound (PALMS)|
12056901|NCT00137631|Behavioral|Many Men, Many Voices (3MV)|Small-group, 6-session HIV prevention intervention for Black MSM.
12056902|NCT00137618|Behavioral|Educational Intervention to Increase Informed Decision Making for Prostate Cancer Screening|
12056903|NCT00137605|Biological|Pneumovax|
12056904|NCT00137605|Biological|Prevnar|
12056905|NCT00137592|Behavioral|small media, group education (multicomponent)|
12056906|NCT00137579|Procedure|Influenza vaccine intramuscular administration route|
12056907|NCT00137566|Drug|acetaminophen (paracetamol)|Paracetamol tablets, 50 mg/kg/day for 3 days.
12056908|NCT00137566|Other|Placebo|
12056911|NCT00137540|Drug|anti-arrhythmic drug therapy|
12056912|NCT00137527|Device|Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion|
12056913|NCT00137514|Drug|chloroquine|
12056914|NCT00137514|Drug|amodiaquine|
12056915|NCT00137501|Drug|Nifedipine|"Arm A:
~Nifedipine 20 mg sublingual, repeated after 30 minutes if contractions do not decrease in intensity. Maintenance of 120-160 mgs of slow-release nifedipine daily for 48 hours.Once contractions cease, nifedipine will be maintained at 80-120 mg daily in divided doses up to 36 weeks.
~Arm B:
~Nifedipine 10 mg sublingual crushed, then 10 mg in 15 min, followed by 10 mg PO Q 15 mins PRN to a maximum of 40 mg in the first hour. Maintenance of 60-80 mgs of slow-release nifedipine daily for 48 hours. Once contractions cease, nifedipine will be maintained at 60 mg daily in divided doses up to 36 weeks."
12056916|NCT00137488|Device|imaging and angiogenic profiles|Image tumor angiogenesis by DCE-MRI using 1.5- or 3-T MRI instruments (13,14,15) pre-and postoperatively (before biopsy or surgery).
12056917|NCT00137475|Procedure|Intensity-Modulated Radiation Therapy|
12056918|NCT00137462|Drug|torcetrapib/atorvastatin|
12056919|NCT00137462|Drug|atorvastatin|
12056920|NCT00137449|Drug|SU011248|37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.
12056921|NCT00137436|Drug|Docetaxel|Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks).
12056922|NCT00137436|Drug|Prednisone|Prednisone Phase1/2 - 5 mg twice a day (BID), oral.
12056923|NCT00137436|Drug|SU011248|SU011248 Phase 1 - escalating doses (12.5, 37.5, and 50 mg), oral, administered on a 2-weeks on, 1-week off daily regimen (Schedule 2/1). Phase 2 - Phase 1 optimal combination dose (37.5 mg/day, oral, Schedule 2/1).
12056924|NCT00137423|Drug|SU011248 (sunitinib)|37.5 mg/day, oral, continuous daily dosing
12056925|NCT00137410|Drug|Celebrex|
12056926|NCT00137397|Drug|Tolterodine ER|
12056927|NCT00137397|Drug|Placebo|
12056928|NCT00137371|Drug|PVC (daily for 21 days, 7 days off)|
12056929|NCT00137371|Drug|PVC (twice weekly)|
12056930|NCT00137358|Procedure|Radiation Therapy|
12056931|NCT00137358|Drug|Cisplatin|
12056932|NCT00137358|Drug|Amifostine|
12056933|NCT00137345|Drug|sirolimus|
12056934|NCT00137332|Drug|GAP-486 (ZP-123)|
12056935|NCT00137332|Drug|0.9% Sodium Chloride, USP|
12056936|NCT00137319|Device|Impedance threshold device|
12056937|NCT00137306|Procedure|Facilitate evidence-based treatment for depression|
12056938|NCT00137293|Drug|GAP-486 (ZP-123)|
12056939|NCT00137293|Drug|0.9% Sodium Chloride, USP|
12056940|NCT00137280|Behavioral|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
12056941|NCT00137267|Behavioral|Time limited case management|This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
12056942|NCT00137267|Behavioral|Health Education|This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.
12056943|NCT00137254|Drug|Insulin|IV insulin
12056944|NCT00137254|Drug|Stable Isotopes|IV administration of stable isotopes
12056945|NCT00137254|Drug|Indocyanine Green|IV administration of ICG
12056946|NCT00137228|Procedure|figure-of-eight hand measurements|
12056947|NCT00137228|Procedure|water volumetry hand measurements|
12056948|NCT00137215|Device|Silverlon|dressing for donor site mamagement
12056949|NCT00137202|Drug|Ondansetron (Zofran)|
12056950|NCT00137202|Drug|Diphenhydramine (Benadryl)|
12056951|NCT00137189|Procedure|Resource-oriented music therapy|
12056952|NCT00137189|Procedure|Standard care|
12056953|NCT00137176|Drug|Rebif|Rebif 44mcg TIW
12056954|NCT00137163|Device|Dermafill Dressing|
12056955|NCT00137150|Procedure|Placement of implants|
12056956|NCT00137137|Procedure|Placement of the mini-screw|
12056957|NCT00137124|Drug|L-Arginine|oral administration of L-arginine for 4 weeks
12056958|NCT00137111|Drug|Prednisone, Dexamethasone, Vincristine, Daunorubicin|See Detailed Description sections for details on treatment interventions.
12056959|NCT00137111|Drug|Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase|See Detailed Description sections for details on treatment interventions.
12056960|NCT00137111|Drug|Methotrexate, Cyclophosphamide, Cytarabine, Etoposide|See Detailed Description sections for details on treatment interventions.
12056961|NCT00137111|Drug|Mercaptopurine, Imatinib|See Detailed Description sections for details on treatment interventions.
12056962|NCT00137111|Procedure|chemotherapy, intrathecal chemotherapy|See Detailed Description sections for details on treatment interventions.
12056963|NCT00137111|Procedure|steroid therapy, hematopoietic stem cell transplantation|See Detailed Description sections for details on treatment interventions.
12056964|NCT00137098|Drug|Caffeine|
12056965|NCT00137085|Drug|ketamine|
12056966|NCT00137072|Drug|Viagra (Sildenafil Citrate) 100 mg|
12056967|NCT00137059|Drug|acetaminophen sustained-release|
12056968|NCT00137046|Drug|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose
12056969|NCT00137046|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose
12056970|NCT00137033|Drug|Celecoxib|
12056971|NCT00137033|Drug|Naproxen|
12056972|NCT00137033|Drug|ASA|
12056975|NCT00137007|Drug|Ampicillin/sulbactam|
12056976|NCT00136994|Drug|Ziprasidone|
12056977|NCT00136981|Drug|torcetrapib/atorvastatin|
12056978|NCT00136981|Drug|atorvastatin|
12056979|NCT00136968|Drug|Voriconazole|
12056980|NCT00136955|Drug|Irinotecan|An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan (60mg/sqm, D1, 8, 15) Plus Cisplatin (60mg/sqm, D1) As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix
12056981|NCT00136942|Drug|Atorvastatin|
12056982|NCT00136929|Drug|Thrombolytic therapy|
12056983|NCT00136929|Procedure|Percutaneous coronary intervention (PCI)|
12056984|NCT00136916|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose
12056985|NCT00136916|Drug|Subcutaneous insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose
12056986|NCT00136903|Drug|Prochymal - 2 million cells|2 million cells/kg actual body weight, intravenously on study Days 1 and 4
12056987|NCT00136903|Drug|Prochymal - 8 million cells|8 million cells/kg actual body weight intravenously on study Days 1 and 4
12056988|NCT00136890|Procedure|PET Imaging|Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)
12056989|NCT00136877|Procedure|(adeno)tonsillectomy|
12056990|NCT00136864|Procedure|PET Diagnostic Imaging|Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy
12056991|NCT00136851|Drug|amlodipine besylate/benazepril hydrochloride|
12056992|NCT00136838|Behavioral|Neutral or active cigarette cues|Packets of cigarettes or cigarette smoke.
12056993|NCT00136825|Drug|N-Acetylcysteine|
12056994|NCT00136825|Drug|Placebo|
12056995|NCT00136812|Behavioral|stage-tailored intervention|This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge.
12056996|NCT00136799|Drug|Fluvastatin|
12056997|NCT00136786|Drug|Memantine|
12056998|NCT00136773|Drug|amlodipine/benazepril|
12056999|NCT00136760|Drug|Bupropion|Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
12057000|NCT00136760|Drug|Contingent reinforcement plus placebo|contingent reinforcement plus placebo (3 weeks)
12057001|NCT00136760|Drug|non-contingent reinforcement plus bupropion|non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
12057002|NCT00136760|Drug|Non-contingent reinforcement plus placebo|Non-contingent reinforcement plus placebo
12057003|NCT00136747|Drug|Memantine|Two capsules of Memantine twice daily for 12 days.
12057004|NCT00136747|Drug|bupropion|
12057005|NCT00136747|Drug|placebo|
12057006|NCT00136734|Drug|Methylphenidate|
12057007|NCT00136734|Other|placebo|placebo
12057008|NCT00136708|Procedure|Neonatal Resuscitation|
12057009|NCT00136695|Drug|anastrozole|1 mg QD
12057010|NCT00136682|Drug|patient-controlled epidural analgesia (PCEA)|During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators.
12057011|NCT00136682|Drug|patient-controlled intravenous analgesia (PCA)|During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators.
12057012|NCT00136669|Procedure|Acupuncture|
12057013|NCT00136656|Drug|antibiotic|cephalosporine by oral route : cefixime
12057014|NCT00136656|Drug|antibiotics|cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
12057015|NCT00136643|Drug|Invisible Condom®|
12057016|NCT00136617|Drug|chlordiazepoxide|
12057017|NCT00136604|Biological|Tritanrix-HepB/Hib-MenAC|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
12057018|NCT00136604|Biological|Mencevax ACWY|GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
12057019|NCT00136604|Biological|Tritanrix-HepB/Hiberix|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
12057020|NCT00136604|Biological|Meningitec|Wyeth's MenC CRM197 conjugated vaccine, Meningitec
12057021|NCT00136591|Drug|Bortezomib|Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle
12057022|NCT00136591|Drug|Bortezomib|Arm B: a 35-day cycle of 1.6 mg/m2 Velcade™once weekly for 4 weeks. Days 1, 8, 15, and 22 of a 35-day cycle. Subjects in this treatment arm will receive a total of 6 cycles of treatment, approximately 30 weeks.
12057023|NCT00136578|Drug|SB-715992|SB-715992 will be available either as 5 milliliter (mL) vial containing 4 milligram (mg) of SB-715992 or 4 mL vial containing 5 mg of SB-715992 at a concentration of 1 mg/mL OR a 10 mL vial that contains 10 mg of SB-715992 in a 10 mL solution at a concentration of 1 mg/mL.
12057024|NCT00136578|Drug|carboplatin|Carboplatin will be available as sterile, lyophilized white powder available in single-dose vials containing 50 mg, 150 mg, and 450 mg of carboplatin for administration by IV infusion. Each vial will be reconstituted with either Sterile Water for Injection, USP, 5% Dextrose in Water (D 5 W), or 0.9% Sodium Chloride Injection, USP.
12057025|NCT00136565|Drug|Velcade|1.5 mg/m², D1, D5, 4 cycles
12057026|NCT00136565|Drug|Doxorubicin|75 mg/m², D1, 4 cycles
12057027|NCT00136565|Drug|Prednisone|60 mg/m², D1-D5, 4 cycles
12057028|NCT00136565|Drug|Cyclophosphamide|1200 mg/m², D1, 4 cycles
12057029|NCT00136565|Drug|Vindesine|2 mg/m², D1, D5, 4 cycles
12057030|NCT00136565|Drug|Bleomycin|10 mg, D1, D5, 4 cycles
12057031|NCT00136552|Drug|rituximab|
12057032|NCT00136539|Drug|Herceptin|Given intravenously once weekly for 12 weeks prior to surgery.
12057033|NCT00136539|Drug|Taxol|Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
12057034|NCT00136539|Drug|Adriamycin|Given every three weeks for 12 weeks after surgery.
12057035|NCT00136539|Drug|Cytoxan|Given every three weeks for 12 weeks after surgery.
12057036|NCT00136526|Drug|Docetaxel and Diethylstilbestrol (DES)|Subjects receive docetaxel 36 Mg/m2weekly for ten cycles (3 weeks out of every 4) and DES 1 mg daily for 40 weeks or until there is evidence of disease progression, whichever occurs first.
12057037|NCT00136513|Drug|SB-743921|
12057038|NCT00136487|Drug|Celecoxib|
12057039|NCT00136474|Drug|Amifostine|Given 30-60 minutes prior to daily radiation therapy
12057040|NCT00136474|Radiation|Radiation Therapy|Daily radiation therapy
12057041|NCT00136461|Drug|All-trans retinoic acid|
12057042|NCT00136461|Drug|Bryostatin 1|
12057043|NCT00136448|Drug|cytosine arabinoside (ara-C)|
12057044|NCT00136448|Drug|daunomycin|
12057045|NCT00136448|Drug|interleukin-2|
12057046|NCT00136435|Drug|prednisone|Induction Phase: Given orally on days 1-28
12057047|NCT00136435|Drug|doxorubicin|Induction Phaese: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle
12057048|NCT00136435|Drug|vincristine|"Induction: Given intravenously on days 1, 8, 15, and 22. If complete remission not acheived, will be given on days 29, 36 and 43.
~CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle"
12057049|NCT00136435|Drug|methotrexate|Induction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks
12057050|NCT00136435|Drug|asparaginase|Induction: Given into the muscle on day 5
12057051|NCT00136435|Drug|dexamethasone|Intensification: Given orally on days 1-5 of each cycle
12057052|NCT00136435|Radiation|cranial radiation|Given in 10 daily treatments during CNS therapy phase
12057053|NCT00136435|Drug|leucovorin|Induction: Given intravenously or orally 36 hours after methotrexate
12057054|NCT00136435|Drug|cytarabine|Induction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks
12057055|NCT00136435|Drug|hydrocortisone|Induction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks.
12057056|NCT00136435|Drug|6-mercaptopurine (6-MP)|CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14.
12057057|NCT00136435|Drug|e. coli L-asparaginase|Intensification: Given in to the muscle weekly.
12057058|NCT00136422|Biological|autologous tumor cells|
12057059|NCT00136409|Drug|Imatinib mesylate|400mg orally once daily until disease progression or unacceptable side effects
12057060|NCT00136396|Drug|Rituximab|Given once weekly for 4 weeks followed by a 4 week observation therapy.
12057061|NCT00136383|Drug|paroxetine versus duloxetine|
12057062|NCT00136370|Drug|Chlorhexidine|
12057063|NCT00136370|Procedure|Birth canal wipe|
12057064|NCT00136370|Procedure|sterile water external genital wipe|
12057065|NCT00136357|Behavioral|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
12057066|NCT00136344|Drug|Cefuroxime|
12057067|NCT00136344|Drug|Levofloxacin|
12057068|NCT00136331|Biological|Pandemic influenza vaccine|
12057069|NCT00136318|Drug|Escitalopram|
12057070|NCT00136318|Drug|Placebo|
12057071|NCT00136318|Drug|Peginterferon alfa-2a|Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly.
12057072|NCT00136318|Drug|Ribavirin|Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.
12057073|NCT00136305|Behavioral|Pictorial asthma action plan|
12057074|NCT00136305|Behavioral|Written asthma action plan|
12057075|NCT00136292|Drug|daptomycin|
12057076|NCT00136279|Behavioral|Linking Lives parent-based intervention|Parent intervention consists of mothers attending two, 2.5 hour-long, face-to-face sessions at the school during which they are given an intervention manual, two homework assignments, and a manual for their adolescent. Parents also receive two booster telephone calls approximately one-month and six-months after completing the intervention. As part of the comparison condition, school-based interventions for adolescents also consist of two, 2.5 hour-long, face-to-face sessions at schools during which they complete either the Project TNT intervention for preventing tobacco use or the Making a Difference intervention for reducing sexual risk behavior.
12057077|NCT00136266|Drug|Ferrous sulphate drops with vitamins A, D, and C|
12057078|NCT00136266|Drug|Ferrous fumarate sprinkles with vitamins and minerals|
12057079|NCT00136253|Behavioral|Help dietitians and patients address specific nutritional barriers|
12057080|NCT00136240|Behavioral|Computer Assisted Education for Behavior Change|
12057081|NCT00136227|Behavioral|small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention|
12057082|NCT00136214|Diagnostic Test|MR brain and neuropsychiatric tests|
12057083|NCT00136201|Drug|tigecycline|
12057084|NCT00136188|Drug|Folic Acid|oral administration of folic acid 5mg /d for 4 weeks
12057085|NCT00136175|Drug|Paclitaxel|
12057086|NCT00136175|Drug|Carboplatin|
12057087|NCT00136175|Drug|Gemcitabine|
12057088|NCT00136149|Procedure|Immediate implants|Immediate implants are used.
12057089|NCT00136136|Procedure|Registration of the bispectral index and spectral edge frequency|Registration of the bispectral index and spectral edge frequency
12057255|NCT00134719|Biological|Prevenar®|One intramuscular dose at 2, 4 and 6 months of age
12057090|NCT00136123|Procedure|Placement of functional loaded synthetic teeth after placement implants|Placement of functional loaded synthetic teeth after placement implants
12057091|NCT00136110|Drug|Sodium Valproate|
12057092|NCT00136097|Device|Placement of a silver impregnated central venous catheter|
12057093|NCT00136084|Drug|Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone|Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
12057094|NCT00136084|Drug|Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine|Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
12057095|NCT00136071|Device|Transobturator tape-ARIS|
12057096|NCT00136071|Device|TVT-O|
12057097|NCT00136058|Procedure|bone densitometry (DEXA)|
12057098|NCT00136058|Drug|alendronate or risedronate|
12057099|NCT00136045|Drug|Rotigotine|
12057100|NCT00136032|Drug|Somatropin|Stratified based on age and estrogen status from 3 to 6 mcg/kg/day
12057101|NCT00136032|Drug|Placebo|Dosage based on age and estrogen status ranging from 3 to 6 mcg/kg/day
12057102|NCT00136019|Drug|SPM 927|
12057103|NCT00136006|Behavioral|Study to determine the burden of disease|
12057104|NCT00135993|Drug|Rotigotine|
12057105|NCT00135980|Behavioral|professional audit and feedback|
12057106|NCT00135980|Behavioral|integrated care programmes|
12057107|NCT00135967|Drug|mycophenolate mofetil orally 1000 mg twice a day (BID)|
12057108|NCT00135967|Drug|prednisone 0,5 mg/kg orally on alternate days|
12057109|NCT00135967|Drug|intravenous (i.v.) methylprednisolone 1000 mg, total 9|
12057110|NCT00135954|Drug|Cyclophosphamide and steroids|comparison of difference in time of start of therapy
12057111|NCT00135941|Drug|insulin glargine|Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks.
12057112|NCT00135941|Drug|insulin glulisine|Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks.
12057113|NCT00135928|Drug|Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)|
12057114|NCT00135902|Drug|17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement|Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.
12057115|NCT00135902|Drug|17 alpha-hydroxy progesterone caproate and Placebo supplement|Participants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements
12057116|NCT00135889|Drug|Femoral perineural infusion|
12057117|NCT00135876|Drug|dalteparin|
12057118|NCT00135863|Drug|tinzaparin|
12057119|NCT00135850|Genetic|VEGF-A165 plasmid|
12057120|NCT00135837|Drug|Verteporfin for injection|
12057121|NCT00135824|Drug|Povidone K25 eye drops (povidone)|
12057122|NCT00135811|Drug|Cyclosporin|Participants assigned to this group will initiate treatment with CSA, 5-6 mg/kg per day with a 250 mg/day maximum starting dose, divided into two daily doses. The CSA dose will be adjusted based on drug levels determined at specified study visits in order to achieve a 12-hour trough concentration in the therapeutic range of 100-250 ng/ml.
12057123|NCT00135811|Drug|MMF and Dexamethasone|"MMF, 25-36 mg/kg per day with a maximum dose of 2 g/day divided into two daily doses. The dose range reflects the use of fixed size (250 mg) capsules and application of defined daily doses to specific weight ranges (see Table below). In younger children or those participants who are unable to swallow capsules, a liquid formulation will be used to provide 36 mg/kg per day to a maximum of 2 g per day. The starting MMF dose will be 0.5-0.67 of the full dose for 2 weeks before advancing to the full dose for the duration of the 12-month treatment period.
~Dexamethasone, 0.9 mg/kg per dose, with a maximum dose of 40 mg"
12057124|NCT00135798|Drug|LADR Treatment|"PEG-Intron (peginterferon alfa-2b (PEGIFN)) Redipen; Rebetol (ribavirin (RBV) United States Pharmacopeia (USP)) Capsules:
~Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was <0.5 ug/kg, PEGIFN was permanently discontinued."
12057125|NCT00135785|Drug|Bupropion|
12057126|NCT00135785|Drug|Placebo|
12057127|NCT00135759|Drug|Naltrexone|low dose naltrexone in addition to daily methadone taper
12057128|NCT00135759|Drug|Placebo comparator|1 capsule/day for 6 days
12057129|NCT00135759|Drug|naltrexone|0.125 mg capsule/day for 6 days
12057130|NCT00135759|Drug|naltrexone|0.250 mg capsule/day for 6 days
12057131|NCT00135746|Drug|nicotine transdermal system|
12057132|NCT00135733|Drug|Amevive (Alefacept)|
12057133|NCT00135733|Drug|Placebo|
12057134|NCT00135720|Drug|Enbrel (Etanercept)|
12057135|NCT00135707|Drug|Dietary Supplement/Vitamins|Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.
12057136|NCT00135707|Drug|Placebo for Vitamin C and Vitamin E|Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.
12057137|NCT00135694|Drug|calcineurin inhibitor-based immunosuppression|May be cyclosporine, mycophenolate mofetil, or tacrolimus
12057138|NCT00135694|Procedure|liver transplant|Occurs at study entry
12057139|NCT00135694|Drug|corticosteroids|3-month course of corticosteroids
12057324|NCT00134212|Drug|Epinephrine|
12057140|NCT00135694|Other|immunosuppression withdrawal|One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance.
12057141|NCT00135681|Drug|nedocromil budesonide|
12057142|NCT00135668|Drug|nitroprusside|nitroprusside IV infusion 0.3-3 mcg/kg/ min
12057143|NCT00135655|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
12057144|NCT00135642|Biological|Subcutaneous Alutard SQ grass pollen (Phleum pratense)|
12057145|NCT00135642|Procedure|Venepuncture: 20 ml blood sample taken on 2 separate visits|
12057146|NCT00135629|Biological|Sublingual Alutard SQ grass pollen tablets (Phleum pratense)|
12057147|NCT00135629|Procedure|Venepuncture: 100ml blood sample taken on 12 separate visits|
12057148|NCT00135616|Device|surgical placement of a suburethral sling tvt or tvt-o|
12057149|NCT00135603|Drug|amoxicillin/clavulanate potassium|1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks
12057150|NCT00135603|Procedure|appendectomy|ablation of the appendix by laparotomy or laparoscopy
12057151|NCT00135590|Dietary Supplement|Protein pulse-feeding|Dietary protein (80% of daily intake) was consumed in one meal (12.00h)
12057152|NCT00135590|Dietary Supplement|Spread diet|Dietary protein was spread over the four meals.
12057153|NCT00135577|Drug|alvimopan|
12057154|NCT00135577|Drug|placebo|
12057155|NCT00135564|Biological|MenC-TT|
12057156|NCT00135564|Biological|Hib-MenC-TT|
12057157|NCT00135551|Drug|Angiotensin receptor blockers|benidipine+angiotensin receptor blocker, titlation scheme
12057158|NCT00135551|Drug|β-blockers|benidipine+β-blockers, titlation scheme
12057159|NCT00135551|Drug|thiazide diuretics|benidipie+thiazide diuretics, titlation scheme
12057160|NCT00135538|Device|Noninvasive positive pressure ventilation|
12057161|NCT00135525|Drug|Paroxetine|"Fixed Dose (20 mg/day): The fixed dose of 20 mg/day was selected, because it is the recommended dose for the treatment of GAD in the US and other countries.
~Flexible Dose (20 - 40 mg/day): Overseas, the maximum dose in the treatment of GAD is 50 mg/day. However, 40 mg/day was selected as the maximum dose for this flexible dose session, because overseas clinical studies have indicated that paroxetine is sufficiently effective at doses of 20 - 40 mg/day and this is the dose range approved for depression/depressive episodes in Japan."
12057162|NCT00135525|Drug|Placebo|Placebo
12057163|NCT00135512|Drug|bupropion hydrochloride|Study drug
12057164|NCT00135499|Drug|Rituximab|375 mg/m², D1, 4 cycles
12057165|NCT00135499|Drug|Doxorubicin|75 mg/m², D1, 4 cycles
12057166|NCT00135499|Drug|Cyclophosphamide|1200 mg/m², D1, 4 cycles
12057167|NCT00135499|Drug|Vindesine|2 mg/m², D1, D5, 4 cycles
12057168|NCT00135499|Drug|Bleomycin|10 mg, D1, D5, 4 cycles
12057169|NCT00135499|Drug|Prednisone|60 mg, D1-D5, 4 cycles
12057170|NCT00135499|Drug|Prednisone|40 mg, D1-D5, 4 cycles
12057171|NCT00135499|Drug|Doxorubicin|50 mg/m², D1, 4 cycles
12057172|NCT00135499|Drug|Cyclophosphamide|750 mg/m², D1, 4 cycles
12057173|NCT00135499|Drug|Vincristine|1.4 mg/m², D1, 4 cycles
12057174|NCT00135486|Biological|MenC-TT|
12057175|NCT00135486|Biological|Hib-MenC-TT|
12057176|NCT00135473|Drug|10% Hemohes® (10% Hydroxyethyl starch)|
12057177|NCT00135473|Drug|Sterofundin® (Ringer lactate solution)|
12057178|NCT00135473|Drug|Actrapid® (Insulin)|
12057179|NCT00135460|Drug|nucleoside analogue sparing HAART regimen|
12057180|NCT00135434|Drug|Atazanavir/Ritonavir/Lopinavir/ritonavir|
12057181|NCT00135421|Drug|Pexacerfont|Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
12057182|NCT00135421|Drug|Escitalopram|Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
12057183|NCT00135421|Drug|Placebo|Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
12057184|NCT00135408|Drug|Ipilimumab+ Placebo|Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
12057185|NCT00135408|Drug|Ipilimumab+ Budesonide|Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.
12057186|NCT00135395|Drug|Atazanavir+ritonavir|Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
12057187|NCT00135395|Drug|Lopinavir+ritonavir|Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
12057188|NCT00135382|Drug|Videx EC|
12057189|NCT00135382|Drug|Epivir|
12057190|NCT00135382|Drug|Sustiva|
12057191|NCT00135369|Drug|stavudine extended-release, lamivudine, efavirenz|
12057192|NCT00135356|Drug|Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)|Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks
12057193|NCT00135356|Drug|continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)|Protease inhibitor [PI] combination + 2 NRTIs
12057194|NCT00135343|Drug|Atazanvir/ritonavir + efavirenz|Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
12057195|NCT00135343|Drug|Atazanvir/ritonavir + efavirenz|Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
12057196|NCT00135330|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
12057197|NCT00135330|Drug|rosiglitazone|oral tablet, 2mg or 4mg, twice a day
12057198|NCT00135317|Drug|darbepoetin alfa|
12057199|NCT00135304|Drug|Sensipar®|Cinacalcet hydrochloride
12057200|NCT00135304|Drug|Vitamin D|Vitamin D administered IV
12057201|NCT00135291|Procedure|Leukoreduced blood transfusion|
12057202|NCT00135278|Procedure|CSF Drainage|See Detailed Description
12057203|NCT00135278|Procedure|No CSF Drainage|See Detailed Description
12057204|NCT00135265|Behavioral|smoking cessation, practice change|Providers will be trained in a brief smoking cessation intervention for teens.
12057205|NCT00135252|Procedure|nasal cannula oxygen delivery|
12057206|NCT00135252|Procedure|supplemental oxygen delivery by hood|
12057253|NCT00134719|Biological|MenHibrix (Hib-MenCY-TT)|One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)
12057207|NCT00135239|Procedure|Study care|All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
12057208|NCT00135239|Procedure|Usual care|Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
12057209|NCT00135226|Drug|Aspirin|
12057210|NCT00135226|Drug|Omega-3 Ethyl Esters|
12057211|NCT00135226|Drug|Placebo Aspirin|
12057212|NCT00135226|Drug|Placebo Omega-3 Ethyl Esters|
12057213|NCT00135213|Behavioral|training in smoking cessation|
12057214|NCT00135200|Drug|Iodine I 131 Tositumomab|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 attached to Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from your body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated for you based on the scans performed following the dosimetric dose."
12057215|NCT00135187|Drug|VELCADE|"VELCADE will be used biweekly at 1.3 mg/m2 during week 1 and 2 on (days
~1, 4, 8, and 11) followed by a 1-week break."
12057216|NCT00135187|Drug|Doxil|Doxil will be administered at 30 mg/m2 IV on day 4
12057217|NCT00135187|Drug|Dexamethasone|Dexamethasone at 40 mg during the first cycle and 20 mg during cycles 2-6 po or IV daily on days of VELCADE and day after VELCADE (i.e. days 1, 2, 4, 5, 8, 9, 11, 12). The patient will be treated for six 3-week cycles followed by three 5-week maintenance cycles.
12057218|NCT00135161|Procedure|FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).|FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
12057219|NCT00135148|Procedure|Filling out a questionnaire on libido and possible partner relationship|
12057220|NCT00135148|Procedure|Sex steroid analysis|
12057221|NCT00135135|Drug|Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid|See Detailed Description.
12057222|NCT00135135|Procedure|Radiation therapy, Surgery, Peripheral Stem cell transplant|See Detailed Description.
12057223|NCT00135122|Drug|prednisolone|Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6
12057224|NCT00135109|Drug|SPM 927|
12057225|NCT00135096|Drug|insulin glulisine|PREMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day 0-15 min before the three main meals; metformin (if applicable); and Lantus qd for 52 weeks.
12057226|NCT00135096|Drug|insulin glargine|POSTMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day immediately after a meal (20 min after the start of a meal); metformin (if applicable); and Lantus qd for 52 weeks.
12057227|NCT00135083|Drug|insulin glulisine|"Once Daily Insulin: Subjects will receive insulin glulisine administered once daily 0-15 minutes before the greatest glycemic impact meal of the day starting at one-tenth the total dose of insulin glargine with maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
~Twice Daily: Subjects will receive insulin glulisine administered twice daily 0-15 minutes before the 2 greatest glycemic impact meals of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
~Three Times Daily: Subjects will receive insulin glulisine administered 3 times daily 0-15 minutes before each meal of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units for each meal and additional monitoring as shown in the table below."
12057228|NCT00135070|Drug|Detemir|
12057229|NCT00135057|Drug|insulin glulisine|
12057230|NCT00135057|Drug|insulin glargine|
12057231|NCT00135044|Procedure|intravenous taurine in nutritional supplement|
12057232|NCT00135031|Drug|Bifidobacterium infantis 35624|
12057233|NCT00135018|Drug|celecoxib and chemotherapy|
12057234|NCT00135005|Drug|AMN107, STI571|
12057235|NCT00134992|Drug|Prednisolone acetate|
12057236|NCT00134979|Drug|Formoterol|
12057237|NCT00134966|Drug|capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)|
12057238|NCT00134953|Drug|Rivastigmine|
12057239|NCT00134914|Drug|Buprenorphine|single doses given by sublingual and parenteral routes
12057240|NCT00134901|Drug|Memantine|Memantine
12057241|NCT00134901|Drug|placebo|placebo
12057242|NCT00134888|Drug|Buprenorphine/naloxone|
12057243|NCT00134875|Drug|Buprenorphine/naloxone|Acute doses of buprenorphine/naloxone in each experimental test session. Doses delivered by either sublingual or parenteral routes, and are: 4/1, 8/2, 16/4 mg.
12057244|NCT00134836|Behavioral|Preventive Primary Care Outreach|Nurse home visit at baseline, 6 months, 12 months, including comprehensive assessment using MDS HC, care planning, referral to appropriate services
12057245|NCT00134823|Other|weight based dosing decision support|weight based dosing decision support
12057246|NCT00134810|Biological|Botulinum toxin type A|
12057247|NCT00134784|Drug|[123I]B-CIT SPECT imaging|To assess [123I]B-CIT SPECT imaging
12057248|NCT00134771|Drug|Nutrient enriched infant formula|
12057249|NCT00134758|Drug|Ursodeoxycholic acid|"During 2 years :
~between 40 and 50 kg : 500 mg/day
~between 51 and 75 kg : 750 mg/day
~between 76 and 100 kg : 1000 mg/day"
12057250|NCT00134758|Drug|Placebo|"During 2 years :
~between 40 and 50 kg : 2 tabs/day
~between 51 and 75 kg : 3 tabs/day
~between 76 and 100 kg : 4 tabs/day"
12057251|NCT00134745|Drug|estradiol|tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years
12057252|NCT00134732|Biological|Live attenuated human rotavirus vaccine|
12057254|NCT00134719|Biological|Infanrix® Penta|One intramuscular dose at 2, 4 and 6 months of age
12057256|NCT00134719|Biological|ActHIB®|One intramuscular dose at 2, 4 and 6 months of age
12057257|NCT00134719|Biological|Meningitec®|One intramuscular dose at 2, 4 and 6 months of age
12057258|NCT00134719|Biological|M-M-R®II|One subcutaneous dose at 12-15 months of age
12057259|NCT00134719|Biological|Varivax®|One subcutaneous dose at 12 to 15 months of age
12057260|NCT00134719|Biological|PedvaxHIB®|One intramuscular dose at 12 to 15 months of age
12057261|NCT00134706|Drug|Docetaxel|Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.
12057262|NCT00134706|Drug|Carboplatin|Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.
12057263|NCT00134693|Drug|Prednisolone|
12057264|NCT00134693|Drug|SB-681323|
12057265|NCT00134680|Drug|Letrozole|Letrozole tablets 2.5 mg by mouth daily
12057266|NCT00134680|Drug|Trastuzumab|Weekly trastuzumab (4 mg/kg loading dose given by IV over 90 minutes folowed by 2 mg/kg given by IV weekly over 30 minutes, provided the previous dose was well tolerated.
12057267|NCT00134667|Drug|Photodynamic Therapy (PDT) with Visudyne (verteporfin)|
12057268|NCT00134667|Drug|Macugen (pegaptanib sodium)|
12057269|NCT00134654|Drug|Premarin|Group A: 1.25mg once a day Group B: 1.25mg three time a day Group A has been closed and participants have been given the option of enrolling in Group B. Treamtment can continue until disease progression or serious side effects.
12057270|NCT00134641|Drug|gemcitabine|
12057271|NCT00134641|Drug|vinorelbine|
12057272|NCT00134628|Procedure|Hyperbaric Oxygen Therapy|HBO at 2.0 ATA
12057273|NCT00134628|Procedure|Sham treatment|Normal air under pressure (1.1 ATA)
12057274|NCT00134615|Behavioral|RQP patient health education module|
12057275|NCT00134602|Behavioral|Needs assessment followed by tailored intervention|
12057276|NCT00134589|Behavioral|Academic Detailing (Medical Practices)+Decision Aids (Patients)|
12057277|NCT00134576|Behavioral|Computer Assisted Education for Behavioral Change|TLC-Detect will provide subjects in the intervention group with information about each diagnosed mental health disorder. TLC-Detect will then give the Treatment Module and will tell the intervention subjects that it will call back in one month for a follow-up or the next week if a subject is comorbid with other disorders.
12057278|NCT00134563|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
12057279|NCT00134563|Drug|Placebo (for teriflunomide)|"Film-coated tablet
~Oral administration"
12057280|NCT00134550|Drug|Atorvastatin (10 mg or 80 mg)|
12057281|NCT00134537|Device|Interspinous process and dynamic stabilization|Interspinous process and dynamic stabilization
12057282|NCT00134537|Device|Conservative Care|Medication, exercise and spinal injections
12057283|NCT00134524|Procedure|MME procedure|
12057284|NCT00134511|Drug|Torcetrapib/atorvastatin|
12057285|NCT00134498|Drug|torcetrapib/atorvastatin|
12057286|NCT00134498|Drug|atorvastatin|
12057287|NCT00134485|Drug|torcetrapib/atorvastatin|
12057288|NCT00134485|Drug|atorvastatin|
12057289|NCT00134472|Procedure|Therapeutic mild hypothermia|Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
12057290|NCT00134459|Drug|Bifeprunox|
12057291|NCT00134459|Drug|Placebo|
12057292|NCT00134446|Device|transcranial magnetic stimulation|
12057293|NCT00134433|Genetic|intramyocardial VEGF angiogenesis (at a dose of 2 mg)|
12057294|NCT00134433|Drug|oral L-arginine supplementation (at a dose of 6 g/day)|
12057295|NCT00134420|Drug|Nutropin AQ|Growth Hormone (Nutropin AQ) treatment given to Group 1 immediately Growth Hormone (Nutropin AQ) treatment given to Group 2 after one year observation
12057296|NCT00134420|Procedure|Arginine and Clonidine Stimulation Testing|This testing was done to determine growth hormone status prior to starting treatment.
12057297|NCT00134420|Procedure|Growth Factors Laboratory Testing|This involved assessment of growth factors such as IGF#1 before treatment was initiated.
12057298|NCT00134420|Procedure|Neuropsychological Testing|This testing was done prior to treatment and at the end of treatment.
12057299|NCT00134407|Procedure|Normal diet|
12057300|NCT00134407|Procedure|Nutrition via jejunal needle-catheter|
12057301|NCT00134394|Drug|Etanercept plus tacrolimus|
12057302|NCT00134381|Drug|Green Tea|Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
12057303|NCT00134381|Drug|Placebo|Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
12057304|NCT00134368|Drug|Etanercept|
12057305|NCT00134355|Drug|PTK787|
12057306|NCT00134342|Other|T-SPOT TB ELISPOT test|ELISPOT test for detecting T cell responses to tuberculosis antigens.
12057307|NCT00134329|Procedure|Filling out a questionnaire on the possible occurrence of erectile dysfunction|
12057308|NCT00134316|Behavioral|psychoeducational intervention|three 75 minute long individual psychoeducational sessions
12057309|NCT00134303|Drug|Metformin|Metformin is used.
12057310|NCT00134290|Drug|metformin|
12057311|NCT00134290|Behavioral|"standard diet advice"|
12057312|NCT00134290|Behavioral|"personal diet advice"|
12057313|NCT00134277|Procedure|Infragenual dilatation|Infragenual dilatation
12057314|NCT00134277|Procedure|Infragenual dilatation with stenting|Infragenual dilatation with stenting
12057315|NCT00134277|Procedure|Infragenual dilatation with cutting balloon|Infragenual dilatation with cutting balloon
12057316|NCT00134277|Procedure|Laser therapy|Laser therapy
12057317|NCT00134264|Drug|torcetrapib/atorvastatin|
12057318|NCT00134264|Drug|atorvastatin|
12057319|NCT00134251|Drug|SLV308|
12057320|NCT00134238|Drug|torcetrapib/atorvastatin|
12057321|NCT00134238|Drug|atorvastatin|
12057322|NCT00134225|Device|Muscle Pattern Recognition (MPR)|
12057323|NCT00134212|Drug|Dopexamine and norepinephrine|
12057327|NCT00134186|Drug|motexafin gadolinium|
12057328|NCT00134173|Drug|torcetrapib/atorvastatin|
12057329|NCT00134173|Drug|atorvastatin|
12057330|NCT00134160|Drug|Olmesartan medoxomil|Olmesartan medoxomil 40mg/Day
12057331|NCT00134160|Drug|Calcium channel blockers (amlodipine, azelnidipine)|Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)
12057332|NCT00134147|Drug|Inhaled Insulin|
12057333|NCT00134134|Drug|efalizumab|
12057334|NCT00134108|Behavioral|Cognitive Behaviour Therapy|
12057335|NCT00134095|Drug|irinotecan hydrochloride|
12057336|NCT00134095|Drug|tegafur-gimeracil-oteracil potassium|
12057337|NCT00134095|Procedure|adjuvant therapy|
12057338|NCT00134095|Procedure|conventional surgery|
12057339|NCT00134095|Procedure|neoadjuvant therapy|
12057340|NCT00134082|Biological|KGEL vaccine|Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1.
12057341|NCT00134082|Biological|Filgrastim|5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.
12057342|NCT00134082|Biological|Rituximab|375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
12057343|NCT00134082|Drug|Cyclophosphamide|50 mg/kg/day on Day -3, -2, -1, and 0.
12057344|NCT00134069|Drug|sorafenib tosylate|Given orally
12057345|NCT00134069|Drug|cetuximab|Given IV
12057346|NCT00134069|Drug|irinotecan hydrochloride|Given IV
12057347|NCT00134056|Drug|atrasentan hydrochloride|Given orally
12057348|NCT00134056|Drug|docetaxel|Docetaxel given IV and prednisone given orally
12057349|NCT00134056|Drug|prednisone|Docetaxel given IV and prednisone given orally
12057350|NCT00134056|Other|placebo|Given orally
12057351|NCT00134043|Drug|vorinostat|Given orally
12057352|NCT00134030|Drug|Cisplatin|Given IV
12057353|NCT00134030|Drug|Doxorubicin Hydrochloride|Given IV
12057354|NCT00134030|Drug|Etoposide|Given IV
12057355|NCT00134030|Drug|Ifosfamide|Given IV
12057356|NCT00134030|Drug|Methotrexate|Given IV
12057357|NCT00134030|Biological|Peginterferon Alfa-2b|Given subcutaneously
12057358|NCT00134030|Other|Quality-of-Life Assessment|Ancillary studies
12057359|NCT00134030|Other|Questionnaire Administration|Ancillary studies
12057360|NCT00134030|Procedure|Therapeutic Conventional Surgery|Undergo amputation or limb salvage surgery
12057361|NCT00134017|Drug|Busulfan|Days -7 to -4: 4 mg/kg PO daily OR 3.2 mg/kg IV daily OR 160 mg/m^2 daily (for pediatric recipients)
12057362|NCT00134017|Drug|Cyclophosphamide|Days -3, -2, +3, +4: 50 mg/kg IV daily
12057363|NCT00134004|Drug|cyclophosphamide|
12057364|NCT00134004|Drug|fludarabine phosphate|
12057365|NCT00134004|Drug|mycophenolate mofetil|
12057366|NCT00134004|Drug|tacrolimus|
12057367|NCT00134004|Procedure|allogeneic bone marrow transplantation|
12057368|NCT00134004|Radiation|radiation therapy|
12057369|NCT00133991|Biological|Filgrastim|5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.
12057370|NCT00133991|Biological|Rituximab|375 mg/m^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m^2 on Day -4 of HiCy and weekly for four weeks after HiCy.
12057371|NCT00133991|Drug|Cyclophosphamide|1500 mg/m^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.
12057372|NCT00133991|Drug|Cytarabine|100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
12057373|NCT00133991|Drug|Methotrexate|3 g/m^2 on Day 8 of each cycle of R-CVP.
12057374|NCT00133991|Drug|Prednisone|100 mg on Days 1-5 of each cycle of R-CVP.
12057375|NCT00133991|Drug|Hydrocortisone|50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
12057376|NCT00133991|Drug|Vincristine|1.4 mg/m^2 on Day 1 of each cycle of R-CVP.
12057377|NCT00133991|Drug|Leucovorin|25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.
12057378|NCT00133978|Other|Glutamine|0.35 gm/kg/day parenterally and 30 gms/day enterally
12057379|NCT00133978|Other|Antioxidants|500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally
12057380|NCT00133978|Other|Glutamine + Antioxidants|0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg
12057381|NCT00133978|Other|Placebo|Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)
12057382|NCT00133965|Behavioral|Dignity Psychotherapy|At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires.will also receive three visits by a mental health professional over a period of five to seven days. You will be asked to fill out some brief questionnaires during this session which ask about feelings about your illness, symptoms, emotional reactions, and support you have available. The second meeting will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the Research Staff.The third meeting you will also be asked to fill out several questionnaires,including a specific questionnaire regarding your thoughts about the Dignity Psychotherapy Intervention. Total time commitment for this study should be approximately 120-150 minutes.
12057383|NCT00133965|Behavioral|Supportive Psychotherapy|you will receive the standard care you normally would receive, but will also receive three visits by a mental health professional over a period of five to seven days. The initial visit will take approximately 45 minutes. You will be asked to fill out brief questionnaires (described above) during this session.A second contact will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the research staff. During this second session, you will have the opportunity to discuss with a supportive research therapist issues or topics relevant to your experience of coping with cancer.The third and final contact,you will be asked you to fill out questionnaires similar to those you filled out at the beginning of the study. Total time commitment for this study should be approximately 120-150 minutes.
12057439|NCT00133536|Biological|Influenza A/H5N1 Vaccine|Monovalent inactivated subvirion influenza H5N1 vaccine (derived from A/Vietnam/1203/04). Packaged in single-dose vials of 90 mcg/mL (0.7 mL/vial). Dosage 45 mcg/0.5 mL administered intramuscularly.
12057384|NCT00133965|Behavioral|Standard Palliative Care|"If you are in the Standard Palliative Care group you will receive the standard care that is usually provided here at Memorial Hospital. This can include services such as consultations by physicians, nurses and other healthcare professionals. In addition, referrals to community resources and services can also be made. The study period will be between five and seven days. At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires as described above. Total time commitment for this study should be approximately 60-90 minutes."
12057385|NCT00133952|Drug|Ruboxistaurin|Administered orally
12057386|NCT00133952|Drug|Placebo|Administered orally
12057387|NCT00133939|Procedure|Mechanical ventilation|
12057388|NCT00133926|Procedure|Treatment of periodontal disease|
12057389|NCT00133913|Procedure|Phlebotomy|Peripheral blood draws for testing of circulating tumor cells
12057390|NCT00133900|Procedure|Phlebotomy|Peripheral blood draws for evaluation of circulating tumor cells
12057391|NCT00133887|Drug|rapamycin|3 to 5 mg/day
12057392|NCT00133887|Drug|ciclosporine|Blood residual level < or = to 125 ng/ml
12057393|NCT00133887|Drug|tacrolimus|Blood residual level < or = to 8 ng/ml
12057394|NCT00133874|Drug|SB-275833 ointment, 1%|
12057395|NCT00133861|Drug|Botulinum toxin|
12057396|NCT00133848|Drug|SB-275833 ointment, 1%|
12057397|NCT00133835|Procedure|Extracorporeal shock wave lithotripsy|
12057398|NCT00133835|Procedure|Endoscopic drainage of the main pancreatic duct|
12057399|NCT00133822|Drug|Sertraline and Risperidone|
12057400|NCT00133809|Drug|Transplantation of Human Islets|Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure
12057401|NCT00133796|Drug|Herceptin|IV
12057402|NCT00133783|Behavioral|intermedin|
12057403|NCT00133770|Drug|pantoprazole|The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
12057404|NCT00133757|Drug|Bupropion SR|
12057405|NCT00133744|Dietary Supplement|folic acid|pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
12057406|NCT00133744|Dietary Supplement|folic acid plus iron|pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe
12057407|NCT00133744|Dietary Supplement|supplements with multiple vitamins and minerals|pills, one per day, from the first prenatal visit until delivery; folic acid 400 mcg, Fe 30 mg, vitamin(vit) A 800 mcg, vit E 10 mg, vit D 5 mcg, vit C 70 mg, vit B1 1.4 mg, vit B2 1.4 mg, vit B6 1.9 mg, vit B12 2.6 mcg, Niacin 18 mg, Zn 15 mg, Cu 2mg, Iodine 150 mcg, Selenium 65 mcg
12057408|NCT00133731|Drug|Otamixaban (XRP0673)|
12057409|NCT00133731|Drug|Unfractionated Heparin|
12057410|NCT00133731|Procedure|Percutaneous Coronary Intervention|
12057411|NCT00133718|Drug|Combined lifestyle intervention and optimisation of pharmacological treatment|"6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)
~standard care"
12057412|NCT00133705|Drug|Mifepristone|Mifepristone 5mg/day by mouth for 6 months
12057413|NCT00133705|Drug|Inert Capsule|sugar pill
12057414|NCT00133692|Drug|Verapamil SR/Trandolapril/Hydrochlorothiazide (HCTZ)|
12057415|NCT00133692|Drug|Atenolol/HCTZ/Trandolapril|
12057416|NCT00133679|Drug|sildenafil|Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
12057417|NCT00133679|Drug|Placebo|Placebo suspension (equal volume to experimental drug) x 45 days
12057418|NCT00133666|Behavioral|Asthma Communication Education|
12057419|NCT00133666|Behavioral|Standard Asthma Education|
12057420|NCT00133653|Behavioral|Observational|
12057421|NCT00133640|Drug|cholecalciferol|
12057422|NCT00133640|Behavioral|Physiotherapy|
12057423|NCT00133627|Drug|Ketotifen|
12057424|NCT00133614|Procedure|Prone Positioning|
12057425|NCT00133601|Behavioral|Cognitive Behavioral Therapy|CBT-I including sleep restriction, stimulus control, sleep hygiene instructions and one session of cognitive therapy devoted to catastrophic thoughts about the consequences of insomnia.
12057426|NCT00133588|Biological|Trivalent split Inf|
12057427|NCT00133575|Biological|MVA Smallpox Vaccine|MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10^7 or 10^8 TCID50 intramuscularly (IM).
12057428|NCT00133575|Biological|MVA Smallpox Vaccine|MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10^7 or 10^8 TCID50 subcutaneously (SC).
12057429|NCT00133575|Other|Placebo|Sterile saline (0.9%) volume of 0.5 ml intradermally in the deltoid.
12057430|NCT00133575|Other|Placebo|Sterile saline (0.9%) volume of 0.5 ml subcutaneously in the deltoid.
12057431|NCT00133575|Biological|MVA Smallpox Vaccine|MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10^6 or 10^7 TCID50 intradermally (ID).
12057432|NCT00133575|Biological|Live vaccinia virus vaccine|Dryvax® smallpox vaccine administered at approximately day 180, dosage 10^8 pfu/ml.
12057433|NCT00133575|Other|Placebo|Sterile saline (0.9%) volume of 0.5 ml intramuscularly in the deltoid.
12057434|NCT00133562|Drug|Alanyl-glutamine|
12057435|NCT00133562|Drug|Glycine|
12057436|NCT00133549|Drug|Placebo|Saline placebo administered in a volume of 0.5 ml intramuscularly.
12057437|NCT00133549|Biological|PNU-IMUNE®23|The 23-valent pneumococcal vaccine (PS) vaccine will contain a mixture of 25 micrograms purified, pneumococcal polysaccharide of each of 23 serotypes of Streptococcus pneumoniae per 0.5 ml dose in isotonic saline and 0.01% thimerosal. The vaccine will be administered in a volume of 0.5 ml intramuscularly.
12057438|NCT00133549|Biological|Nine-valent pneumococcal conjugate (PNCRM9)|Cross-reactive material 197 (CRM 197) is a product of the Corynebacterium diphtheria C7. Vaccine is prepared from pneumococcal polysaccharides of types 1, 4, 5, 9V, 14, 18C, 19F, 23F (2 mcg each) and 6B (4 mcg) covalently linked to CRM197 by reductive amination. The protein-polysaccharide combination is prepared as a lyophilized powder with aluminum phosphage which is reconsitituted before use. The vaccine will be administered in a volume of 0.5 ml intramuscularly.
12057440|NCT00133536|Drug|Placebo|Normal saline administered intramuscularly.
12057441|NCT00133523|Biological|Cold-adapted live attenuated influenza virus vaccine, trivalent|Live-attenuated influenza vaccine; single annual dose administered as an intranasal spray.
12057442|NCT00133523|Other|Placebo|Physiological saline administered as an intramuscular injection.
12057443|NCT00133523|Biological|Trivalent inactivated influenza vaccine|Inactivated influenza vaccine; single annual dose administered as an intramuscular injection..
12057444|NCT00133523|Biological|Trivalent inactivated influenza vaccine|Inactivated influenza vaccine; single annual dose administered as an intramuscular injection.
12057445|NCT00133523|Other|Placebo|Normal allantoic fluid administered annually as an internasal spray.
12057446|NCT00133510|Biological|Trivalent Subviron Influenza vaccine (Fluzone)|
12057447|NCT00133497|Biological|MF-59|Microfluoridized adjuvant 59 (MF59).
12057448|NCT00133497|Drug|Placebo|0.5 mL of saline placebo.
12057449|NCT00133497|Biological|CMV gB vaccine|CMV glycoprotein B (gB) delivered as 20 mcg in 0.5 mL of vaccine.
12057450|NCT00133484|Biological|Anthrax vaccine absorbed made from Bacillus anthracis (AVA)|
12057451|NCT00133484|Biological|Recombinant protein antigen (rPA) made from Bacillus anthrax|
12057452|NCT00133484|Biological|Recombinant protein antigen (rPA) made from Escherichia coli|
12057453|NCT00133471|Biological|Influenza A/H9N2 vaccine|A single lot of monovalent inactivated SA influenza A/H9N2 vaccine. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Dosage levels are: 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant.
12057454|NCT00133471|Drug|MF59 adjuvant|MF59 adjuvant is an oil-in-water emulsion.
12057455|NCT00133458|Drug|Albendazole|
12057456|NCT00133445|Biological|DTaP-Hep B-IPV Vaccine|U.S. licensed 13-Dec-2002. Dosage equal to 0.5 mL administered intramuscularly. Combination vaccine.
12057457|NCT00133445|Biological|Monovalent Hep B Vaccine|U.S. licensed monovalent hepatitis B vaccine; each 0.5 mL dose contains 10 mcg of hepatitis B surface antigen absorbed on 0.25 mg aluminum hydroxide. The vaccine is given to infants as a 0.5 mL dose intramuscularly.
12057458|NCT00133445|Drug|Placebo|Commercially prepared normal saline. The dose will be 0.5 mL administered intramuscularly.
12057459|NCT00133432|Drug|Zinc|
12057460|NCT00133419|Drug|Vitamin + Zinc + micronutrient mixture|
12057461|NCT00133419|Drug|Vitamin A|
12057462|NCT00133419|Drug|Vitamin A + Zinc|
12057463|NCT00133406|Drug|Glutamine|0.8gm/kg, ie up to a total daily dose of 16.2gm/day,with juice daily for 10 days
12057464|NCT00133406|Drug|Vitamin A|100,000 IU for children under 12 months of age (or placebo) and PO 200,000 IU for children at least 12 months of age (or placebo), both q months for 1 year at 0, 4 and 8 months.
12057465|NCT00133406|Drug|glycine|0.4gm/kg; ie up to 8.3gm/d, with juice daily for 10 days
12057466|NCT00133406|Drug|zinc|40 mg twice weekly for 12 months
12057467|NCT00133393|Drug|Pentoxifylline|
12057468|NCT00133380|Drug|PPAR alpha|
12057469|NCT00133380|Drug|atorvastatin|
12057470|NCT00133380|Drug|placebo|
12057471|NCT00133367|Drug|Tacrolimus|Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
12057472|NCT00133367|Drug|Sirolimus|Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
12057473|NCT00133367|Drug|G-CSF|Given starting on day 5 after transplant until the subjects white blood cell count recovers.
12057474|NCT00133367|Drug|Antithymocyte globulin|Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
12057475|NCT00133367|Drug|Thymoglobulin|Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
12057476|NCT00133367|Drug|Fludarabine|Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).
12057477|NCT00133367|Drug|Melphalan|Given intravenously on day 2 before transplant.
12057478|NCT00133354|Drug|Arimidex (Anastrozole)|Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.
12057479|NCT00133354|Drug|Placebo|Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.
12057480|NCT00133354|Drug|Growth Hormone|GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of ~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.
12057481|NCT00133341|Drug|Goldnatriomthiosulphate, MDBGN, parthenolide|
12057482|NCT00133328|Drug|valsartan|
12057483|NCT00133315|Drug|Infliximab|
12057484|NCT00133315|Drug|Etanercept|
12057485|NCT00133315|Drug|Adalimumab|
12057486|NCT00133302|Drug|Standard CHOP|
12057487|NCT00133302|Drug|Bi-CHOP (dose intensified CHOP)|
12057488|NCT00133289|Device|Pacemaker with Automatic Capture|
12057489|NCT00133276|Drug|Escitalopram|OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks
12057490|NCT00133276|Other|Placebo|
12057491|NCT00133263|Behavioral|Primary Bereavement Care|a standardized bereavement intervention in Primary Care
12057492|NCT00133263|Behavioral|the current bereavement care in primary care|the non-standardized bereavement care that usually provided family physicians in primary care
12057493|NCT00133250|Drug|Abciximab|Abciximab bolus and infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 10 mg abciximab. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
12057494|NCT00133250|Other|Placebo Heparin Sodium|Placebo bolus plus infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 3000 U Heparin. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
12057495|NCT00133237|Device|Sirolimus-eluting stent|cypher stent is implanted due to randomization.
12057496|NCT00133237|Device|Paclitaxel-eluting stent|taxus stent is implanted due to randomization.
12057697|NCT00131560|Genetic|VRX496-Modified Autologous T cells|Genetic: Anti-HIV antisense
12057497|NCT00133224|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|Immunotherapy allogeneic GM-CSF secreting cellular vaccine
12057498|NCT00133224|Drug|Chemotherapy (docetaxel and prednisone)|Chemotherapy (docetaxel and prednisone)
12057499|NCT00133211|Procedure|Radiofrequency ablation|Pulmonary vein isolation
12057500|NCT00133198|Drug|Pramipexole|
12057501|NCT00133185|Drug|telmisartan 40 mg/hydrochlorothiazide 12.5 mg|
12057502|NCT00133185|Drug|losartan 50 mg/hydrochlorothiazide 12.5 mg|
12057503|NCT00133172|Drug|Tacrolimus|IV
12057504|NCT00133172|Drug|mycophenolate mofetil|IV
12057505|NCT00133172|Drug|Prednisone|IV
12057506|NCT00133159|Biological|Grass MATAMPL|
12057507|NCT00133146|Biological|Grass MATAMPL|
12057508|NCT00133133|Drug|ALGRX 4975|
12057509|NCT00133107|Drug|efalizumab|
12057510|NCT00133094|Drug|Simvastin|
12057511|NCT00133094|Procedure|Computer-based decision support technology|
12057512|NCT00133081|Drug|All registered antiepileptic drugs|
12057513|NCT00133068|Behavioral|Computer|Computer intervention only
12057514|NCT00133068|Behavioral|Reduction in financial barrier|Copay only
12057515|NCT00133068|Behavioral|Computer intervention & reduction of financial barrier|computer intervention & copay
12057516|NCT00133068|Behavioral|Control|No intervention
12057517|NCT00133055|Behavioral|Self-help treatment booklet and telephone support|The Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems.
12057518|NCT00133055|Behavioral|Usual care by a family physician|Parents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician.
12057519|NCT00133042|Drug|omalizumab|
12057520|NCT00133029|Drug|Timing of prophylactic antibiotic administration|
12057521|NCT00133016|Procedure|Amniotomy|
12057522|NCT00133003|Drug|Abciximab|0.25 mg/kg of body weight bolus, followed by a 0.125-microg/kg per minute [maximum, 10 microg/min] infusion for 12 hours, plus heparin, 70 U/kg of body weight
12057523|NCT00133003|Drug|Placebo|Placebo consist of placebo bolus and infusion of 12 hours (NaCl 0.9%), plus heparin bolus, 140 U/kg of body weight
12057524|NCT00132990|Device|Deep brain stimulation|
12057525|NCT00132977|Device|Cardiac Resynchronization Therapy|
12057526|NCT00132964|Device|Below knee walking cast|Not required
12057527|NCT00132964|Device|Removable ankle brace|not required
12057528|NCT00132951|Drug|Telithromycin|Telithromycin (AECB: 2 tablets per day for Days 1-5; CAP: 2 tablets per day for Days 1-7)
12057529|NCT00132951|Drug|Azithromycin|Azithromycin (AECB: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5; CAP: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5 then 2 placebo tablets per day for Days 6-7)
12057530|NCT00132938|Drug|telithromycin|
12057531|NCT00132925|Drug|Triamcinolone|
12057532|NCT00132912|Drug|SCH 530348|
12057533|NCT00132899|Drug|Methotrexate|Methotrexate and infliximab combination
12057534|NCT00132899|Drug|Placebo|Placebo and infliximab combination therapy.
12057535|NCT00132886|Drug|tolvaptan|
12057536|NCT00132873|Drug|Xyrem (sodium oxybate) oral solution|Xyrem (sodium oxybate) oral solution
12057537|NCT00132860|Drug|azithromycin|
12057538|NCT00132847|Biological|German Cockroach Allergen extract|
12057539|NCT00132834|Device|R-Tube or EcoScreen|Device for collection of exhaled breath condensates (EBC) collection (i.e. condensing and collecting breath vapor from a cold, solid surface)
12057540|NCT00132821|Drug|Bupropion|Days 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm)
12057541|NCT00132821|Drug|Transdermal Nicotine Patch|21-mg nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg patch applied in AM for 2 weeks; 7-mg patch applied in AM for 1 week
12057542|NCT00132821|Drug|Placebo Bupropion|Days 1-3, 150 mg placebo Bupropion in am; days 4-63, 300 mg placebo Bupropion (150 mg in am and 150 mg in pm)
12057543|NCT00132821|Drug|Placebo transdermal nicotine patch|21-mg placebo nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg placebo patch applied in AM for 2 weeks; 7-mg placebo patch applied in AM for 1 week
12057544|NCT00132808|Drug|Zoledronic Acid|Zoledronic acid 5 mg intravenous
12057545|NCT00132808|Drug|Placebo|Physiologic 0.9% normal saline
12057546|NCT00132795|Behavioral|Daily monitoring of alcohol & drug use, & therapy skills|Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).
12057547|NCT00132795|Behavioral|control group|standard care (no added treatment)
12057548|NCT00132769|Drug|MK-0873|MK-0873 1.25 mg twice daily for 12 weeks
12057549|NCT00132769|Drug|Comparator: Placebo|Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
12057550|NCT00132756|Drug|Doxil and Estramustine|
12057551|NCT00132743|Device|Stent|Stent
12057552|NCT00132743|Behavioral|Supervised Exercise Therapy|Supervised exercise therapy, three times per week
12057553|NCT00132743|Drug|Cilostazol|Cilostazol, 100 mg twice a day
12057554|NCT00132730|Drug|MK-0873 2.5 mg|
12057555|NCT00132730|Drug|MK-0873 1.25 mg|
12057556|NCT00132730|Drug|MK-0873 0.75 mg|
12057557|NCT00132730|Drug|Placebo to MK-0873|
12057558|NCT00132730|Drug|Usual Care|
12057559|NCT00132717|Drug|MK0653A (ezetimibe [+] simvastatin)|
12057560|NCT00132717|Drug|Comparator: atorvastatin|
12057561|NCT00132717|Drug|Comparator: fluvastatin|
12057562|NCT00132717|Drug|Comparator: lovastatin|
12057563|NCT00132717|Drug|Comparator: pravastatin|
12057564|NCT00132717|Drug|Comparator: rosuvastatin|
12057565|NCT00132717|Drug|Comparator: simvastatin|
12057698|NCT00131547|Behavioral|Dietary Counseling|Dietary Counseling, use of a food diary and pedometer
12057823|NCT00130676|Drug|Mifepristone|daily for 7 days
12057566|NCT00132704|Radiation|Ionizing radiation (IR) therapy|Tumors will be sliced into 0.5cm fragments, incubated in culture medium and then irradiated to evaluate the kinetics and dose-dependencies of the endothelial apoptotic response. We will irradiate tumor fragments ex vivo at 0, 7, 13, 15, 17, and 25 Gy.
12057567|NCT00132704|Radiation|Ionizing radiation (IR)|Tissue fragments of a total quantity of at least a 4x4x4 cm3 will be required. For each tumor a paraffin block will also be made for routine staining and IHC. Endothelial cell populations (at least 500 cells) will then be exposed to radiation at 0, 7, 11, 13, 15, 17, and 25 Gy and harvested at 4, 5 and 8 hours post IR.
12057568|NCT00132691|Drug|fluocinolone acetonide intraocular implant|RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.
12057569|NCT00132691|Drug|oral corticosteroid with immunosuppressive agents as needed|Prednisone
12057570|NCT00132678|Drug|Risperdal Consta|12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks
12057571|NCT00132678|Drug|Placebo|Matching placebo intramuscular (IM) injection every 2 weeks
12057572|NCT00132665|Procedure|A: Radiotherapy alone|Procedure/Surgery: A: Radiotherapy alone
12057573|NCT00132665|Drug|B: CBDCA and Radiotherapy|Drug: B: CBDCA and Radiotherapy
12057574|NCT00132652|Drug|Lamivudine|
12057575|NCT00132652|Drug|Telbivudine|
12057576|NCT00132639|Drug|Preoperative docetaxel-cisplatin combination chemotherapy|Preoperative docetaxel-cisplatin combination chemotherapy
12057577|NCT00132639|Drug|Preoperative docetaxel monotherapy|Preoperative docetaxel monotherapy
12057578|NCT00132626|Drug|[123I]ß-CIT and SPECT imaging|
12057579|NCT00132613|Procedure|Observation alone after pericardial drainage|
12057580|NCT00132613|Drug|Pericardial instillation of bleomycin after drainage|
12057581|NCT00132600|Drug|bacitracin (allergen)|
12057582|NCT00132587|Device|cement Palacos R40 and LV40|
12057583|NCT00132574|Behavioral|Minimization of milk and dairy products in the diet|
12057584|NCT00132561|Drug|Sulfadoxine/pyrimethamine and artesunate|
12057585|NCT00132548|Drug|Pyrimethamine/sulfadoxine|
12057586|NCT00132548|Drug|Amodiaquine|
12057587|NCT00132548|Drug|Artesunate|
12057588|NCT00132535|Drug|sulfadoxine-pyrimethamine intermittent preventive treatment|
12057589|NCT00132535|Drug|chloroquine|
12057590|NCT00132522|Drug|EMD 273066|"dose-escalating study and subjects enrolled in the study may receive a maximum of 6 cycles of the assigned regimen over 18 weeks. Each cycle will be 3 weeks (21 days) with cyclophosphamide on Day 1 and EMD 273066 on Days 2 to 4, followed by 17 days with no experimental pharmaceutical product.
~Each cycle, cyclophosphamide at 300 mg/m2 given per institutional guidelines 1 day (22-28 hours) prior to 3 consecutive days of EMD 273066 as a 4-hour IV infusion at 1 of 6 planned dose levels of 0.5, 1, 2, 3, 4, or 6 mg/m2."
12057591|NCT00132509|Drug|DFIL|Alteplase : 0.8mg/kg over 90 minutes
12057592|NCT00132509|Drug|NINDS|Alteplase : 0.9mg/kg over 60 minutes
12057593|NCT00132496|Drug|rabeprazole sodium|administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.
12057594|NCT00132483|Behavioral|Instruction in physical training program|Instruction in physical training program.
12057595|NCT00132470|Drug|AX200 (G-CSF)|
12057596|NCT00132457|Procedure|Self-collected vaginal swab for chlamydia testing|
12057597|NCT00132444|Drug|topical vaginal application of UC-781 gel|UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
12057598|NCT00132431|Drug|Sensipar|
12057599|NCT00132418|Drug|Enbrel|Enbrel
12057600|NCT00132418|Drug|Placebo|Placebo
12057601|NCT00132405|Drug|ALGRX 3268|
12057602|NCT00132392|Drug|ALGRX 4975|
12057603|NCT00132379|Drug|ABR-217620|10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles
12057604|NCT00132379|Drug|docetaxel|75mg/m^2, IV, single 60 minute infusion, beginning on Day 5 then every third week
12057605|NCT00132340|Device|Electrodes|
12057606|NCT00132314|Drug|IM risperidone|long-acting injectable risperidone
12057607|NCT00132314|Drug|oral antipsychotic medication|doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)
12057608|NCT00132301|Drug|Docetaxel|Chemotherapy agent
12057609|NCT00132301|Drug|Prednisone|steroid in combination with chemotherapy agent
12057610|NCT00132288|Behavioral|Motivational support|Participants in the PALS program at SE Seattle Senior Center are assigned a volunteer phone buddy who uses motivational interviewing techniques during bi weekly or monthly phone calls to encourage the participant to become more physically active.
12057611|NCT00132288|Behavioral|PALS - Physical activity for lifetime success|Referral by a primary care provider to a community based support program to enhance uptake or maintenance of physical activity by the participants.
12057612|NCT00132275|Drug|Amoxicillin potassium clavulanate|
12057613|NCT00132262|Behavioral|Brief intervention based on motivational interviewing|The intervention was an approximately 30 minute discussion about alcohol-related risk behaviors and motivation to change
12057614|NCT00132262|Behavioral|Standard Care including referral for treatment|Standard hospital care provided the patient with information and referral for treatment as necessary.
12057615|NCT00132236|Drug|nicotine sublingual tablets|
12057616|NCT00132236|Behavioral|low and high behavior support|
12057617|NCT00132223|Drug|Contrast agent|
12057618|NCT00132210|Drug|pegylated interferon|Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.
12057619|NCT00132197|Behavioral|Cognitive Behavioral Therapy|1. Specialised treatment includes cognitive groups therapy in 9 modules of 3,5 hours within 3½ months, in all 31,5 hours, consultancy over the phone to the patients' GPs and tuition in groups headed by an experienced social worker. Detailed treatment manuals are worked out separately for each module. Experienced psychotherapists (clinical psychologists and psychiatrists), who also function as consultants, will do the treatment. The Ph.D.-student functions as co-therapist.
12057820|NCT00130715|Device|Seprafilm Bioresorbable Membrane|
12057620|NCT00132197|Procedure|Recommendation of care (letter to general practitioner [GP])|After the diagnostic assessment the patient does not receive any treatment offers at the research clinic, but the patient and the GP will be informed about the diagnosis, and the GP will receive advice on further treatment possibilities.
12057621|NCT00132184|Drug|Vitamin D|
12057622|NCT00132171|Drug|Sequential therapy|
12057623|NCT00132158|Drug|Irinotecan (Camptosar), Gefitinib (Iressa)|See Detailed Description for treatment plan.
12057624|NCT00132145|Behavioral|Vascular Management Program|
12057625|NCT00132145|Behavioral|Clinical Care Coordinators|
12057626|NCT00132145|Behavioral|Web-based Vascular Tracker for Patient and Physician|
12057627|NCT00132145|Behavioral|Automated Telephone Reminder System|
12057628|NCT00132132|Behavioral|Behavioral education program|Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
12057629|NCT00132119|Drug|nalmefene HCl|Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
12057630|NCT00132119|Other|Placebo|Placebo tablet
12057631|NCT00132106|Drug|phentolamine|
12057632|NCT00132093|Drug|Eplerenone|
12057633|NCT00132080|Drug|Steroids|This study evaluates the efficacy and safety of pulse steroid therapy, when added to conventional treatment with IVIG plus aspirin, in treatment of children with acute Kawasaki disease.
12057634|NCT00132067|Drug|vorinostat|Given orally
12057635|NCT00132054|Drug|amrubicin hydrochloride|
12057636|NCT00132054|Drug|irinotecan hydrochloride|
12057637|NCT00132041|Device|radiofrequency ablation|
12057638|NCT00132028|Drug|vorinostat|Given orally
12057639|NCT00132028|Other|laboratory biomarker analysis|Correlative studies
12057640|NCT00132015|Drug|tanespimycin|
12057641|NCT00132002|Drug|vorinostat|Given PO
12057642|NCT00132002|Other|laboratory biomarker analysis|Correlative studies
12057643|NCT00131989|Drug|sorafenib tosylate|Given orally
12057644|NCT00131989|Other|pharmacological study|Correlative studies
12057645|NCT00131989|Other|laboratory biomarker analysis|Correlative studies
12057646|NCT00131963|Drug|cyclophosphamide|Given IV
12057647|NCT00131963|Drug|doxorubicin|Given IV
12057648|NCT00131963|Drug|paclitaxel|Given IV
12057649|NCT00131950|Other|physiologic testing|
12057650|NCT00131950|Other|study of socioeconomic and demographic variables|
12057651|NCT00131950|Procedure|breast imaging study|
12057652|NCT00131950|Procedure|study of high risk factors|
12057653|NCT00131937|Drug|sorafenib tosylate|Given orally
12057654|NCT00131924|Biological|esterified estrogens|
12057655|NCT00131911|Drug|sorafenib tosylate|400 mg given orally
12057656|NCT00131898|Procedure|Surgical Resection|
12057657|NCT00131898|Procedure|Intensity Modulated Radiation Therapy (IMRT)|
12057658|NCT00131885|Dietary Supplement|Placebo Control (Placebo Herb)|Placebo herb three times daily (ground cellulose) for 4-6 weeks
12057659|NCT00131885|Dietary Supplement|St. John's Wort|St. John's Wort (Hypericum perforatum) orally or 4-6 weeks
12057660|NCT00131885|Drug|Levonorgestrel|Levonorgestrel in a single oral dose
12057661|NCT00131872|Device|Expedial Vascular Access Graft|
12057662|NCT00131859|Procedure|Diffusion-tensor imaging|Obtain a Diffusion tensor MRI of brain.
12057663|NCT00131846|Drug|Thiazide diuretics|Any dosage, frequency, and duration
12057664|NCT00131846|Drug|No diuretics|Any antihypertensive regimen other than diuretics
12057665|NCT00131833|Biological|Typhoid Vi vaccine|
12057666|NCT00131833|Biological|Meningococcal A (control)|
12057667|NCT00131820|Biological|Typhoid Vi vaccine|
12057668|NCT00131820|Biological|Hepatitis A (control)|
12057669|NCT00131807|Procedure|Blood Pressure Measurement|
12057670|NCT00131807|Procedure|Questionnaire|
12057671|NCT00131794|Biological|BCG|
12057672|NCT00131781|Behavioral|Cognitive Therapy|
12057673|NCT00131781|Behavioral|Supportive Therapy|
12057674|NCT00131768|Device|Synvisc (hylan G-F 20)|
12057675|NCT00131755|Drug|diazoxide|
12057676|NCT00131742|Drug|telbivudine|
12057677|NCT00131742|Drug|lamivudine|
12057678|NCT00131729|Behavioral|Educational programme|
12057679|NCT00131716|Drug|sulfadoxine-pyrimethamine|
12057680|NCT00131703|Drug|Amodiaquine|
12057681|NCT00131703|Drug|Sulphadoxine-pyrimethamine|
12057682|NCT00131703|Drug|Chloroquine|
12057683|NCT00131690|Drug|Nescafé Gold Blend (exposed)|
12057684|NCT00131690|Drug|Nescafé Decaffeinated (controls)|
12057685|NCT00131677|Drug|tenofovir disoproxil fumarate|study product taken daily
12057686|NCT00131677|Drug|placebo|study product taken daily
12057687|NCT00131664|Drug|Avandamet|Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily compared to Avandia 4 mg and Amaryl 1 mg once daily over 6 months or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
12057688|NCT00131664|Drug|Avandia and Amaryl|Avandia 4 mg and Amaryl 1 mg once daily compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily, or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
12057689|NCT00131664|Drug|Metformin|Metformin 500 mg twice daily up to 1000 mg over 6 months compared to Avandia 4 mg and Amaryl 1 mg once daily or compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily
12057690|NCT00131651|Drug|ATN-161|
12057691|NCT00131638|Drug|Placebo|Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.
12057692|NCT00131638|Drug|Palifermin|Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course
12057693|NCT00131625|Behavioral|Health education according to WHO recommendations|
12057694|NCT00131612|Drug|FEC 100|5-fluoruracil, epirubicin and cyclophosphamide every three weeks for six treatments
12057695|NCT00131599|Drug|5FU/LV|5FU/LV
12057696|NCT00131573|Device|bion|battery powered bion microstimulator
12057699|NCT00131534|Behavioral|Individual therapy|Stage-based individual therapy for trauma survivors
12057700|NCT00131534|Behavioral|Group therapy|Stage-based group therapy for trauma survivors
12057701|NCT00131521|Drug|mucomyst|
12057702|NCT00131521|Drug|sodium chloride (saline)|
12057703|NCT00131508|Drug|Glutamine|0.6 gm/kg of oral glutamine per day, in two doses for one year.
12057704|NCT00131508|Drug|Placebo|Placebo
12057705|NCT00131495|Drug|Testosterone (transdermal patches)|Testosterone patch (300mcg/day, changed twice a week for one year
12057706|NCT00131495|Drug|Placebo patch|placebo patch changed twice a week for one year
12057707|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
12057708|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.
12057709|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.
12057710|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
12057711|NCT00131482|Drug|Placebo|Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.
12057712|NCT00131469|Drug|Teriparatide (FORTEO)|Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
12057713|NCT00131469|Drug|Placebos|
12057714|NCT00131456|Drug|Venlafaxine|375mg/day
12057715|NCT00131456|Drug|Placebo|Placebo
12057716|NCT00131443|Drug|Topiramate|
12057717|NCT00131430|Drug|taranabant|
12057718|NCT00131417|Drug|ready-to-use therapeutic food|
12057719|NCT00131404|Drug|taranabant|taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
12057720|NCT00131404|Drug|Comparator: Placebo|Placebo capsule once daily. 52 week treatment period.
12057721|NCT00131391|Drug|Comparator: taranabant|taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
12057722|NCT00131391|Drug|Comparator: placebo|Placebo capsule once daily . 52 week treatment period.
12057723|NCT00131378|Drug|Nutropin AQ growth hormone|Participants will give themselves injections of growth hormone every night for 6 months.
12057724|NCT00131378|Drug|Placebo Growth Hormone|Participants will give themselves injections of placebo growth hormone every night for 6 months.
12057725|NCT00131365|Device|ExAblate 2000|
12057726|NCT00131352|Device|hylan G-F 20|Single injection of 6 mL of hylan G-F 20 (Synvisc).
12057727|NCT00131352|Other|Phosphate Buffered Saline|Single injection of 6 mL phosphate buffered saline.
12057728|NCT00131339|Behavioral|Cognitive behavioral therapy|
12057729|NCT00131339|Drug|D-cycloserine|
12057730|NCT00131326|Device|Synvisc (hylan G-F 20)|
12057731|NCT00131313|Drug|Nipent, Cytoxan, Rituxan|
12057732|NCT00131300|Device|Synvisc (hylan G-F 20)|
12057733|NCT00131287|Drug|Extract of Agaricus blazei Murill|
12057734|NCT00131274|Drug|Imatinib Mesylate (Gleevec)|
12057735|NCT00131261|Drug|PXD101|
12057736|NCT00131261|Drug|Dexamethasone|
12057737|NCT00131248|Drug|Metaclopramide|
12057738|NCT00131248|Drug|Ranitidine|
12057739|NCT00131248|Drug|placebo|
12057740|NCT00131235|Drug|Sulfadoxine-pyrimethamine treatment twice during pregnancy|"Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.
~2 placebo tablets for azithromycin taken at the same time points."
12057741|NCT00131235|Drug|Sulfadoxine-pyrimethamine at 4-week intervals|"Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.
~2 placebo tablets for azithromycin taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks."
12057742|NCT00131235|Drug|Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice|"Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.
~2 azithromycin tablets (each 500 mg) taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks."
12057743|NCT00131222|Procedure|Food supplement: fortified spread|
12057744|NCT00131222|Procedure|Food supplement: maize and soy flour|
12057745|NCT00131209|Dietary Supplement|fortified spread (RUTF)|
12057746|NCT00131209|Dietary Supplement|maize and soy flour|
12057747|NCT00131183|Drug|Nebido|
12057748|NCT00131170|Procedure|paravertebral block|
12057749|NCT00131157|Procedure|expert support for interpretation of spirometry|
12057750|NCT00131144|Drug|Octreotide Acetate in Microspheres 20 mg|
12057751|NCT00131144|Drug|Octreotide Acetate in Microspheres|
12057752|NCT00131144|Drug|Placebo|
12057753|NCT00131131|Behavioral|Exercise|
12057754|NCT00131118|Drug|Zoledronic Acid|
12057755|NCT00131105|Behavioral|The Stanford Active Choices program|
12057756|NCT00131092|Behavioral|The Stanford Active Choices program|
12057757|NCT00131092|Behavioral|The TLC system|
12057758|NCT00131079|Behavioral|Experimental Programme for Physical Activity Promotion|"General practitioner's (GP) physical activity (PA) assessment and advise using a web-based software that prompted open questions to elicit believes about benefits of PA, graphical information about risks of inactivity and examples of type sentences to provide medical advise.
~Educational materials summarizing benefits, risks and motivation.
~Prescription: 15 minutes educational session in which GP negotiated a goal, addressed possible barriers and anticipated solutions using web-based tools for lack of time, community resources, and health problems. Finally, they designed a 3-month PA activity plan that derived in a standardized printed prescription of frequency, duration, intensity and progression of a selected PA or exercise that included a self-monitoring log."
12057821|NCT00130702|Drug|gefitinib|gefitinib (Iressa) at a dose of 750 mg, once per day
12057759|NCT00131079|Behavioral|Control|Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care
12057760|NCT00131066|Other|Follow up from previous treatment with MEDI-507|There will be no investigational drugs administered under this protocol.
12057761|NCT00131053|Drug|Methotrexate|
12057762|NCT00131053|Drug|Prednisolone|
12057763|NCT00131053|Drug|Dexamethasone|
12057764|NCT00131053|Drug|Vincristine|
12057765|NCT00131053|Drug|Pirarubicin|
12057766|NCT00131053|Drug|Cyclophosphamide|
12057767|NCT00131053|Drug|L-asparaginase|
12057768|NCT00131053|Drug|Cytarabine|
12057769|NCT00131053|Drug|Hydrocortisone|
12057770|NCT00131053|Drug|Mercaptopurine|
12057771|NCT00131040|Drug|Aprotinin|
12057772|NCT00131027|Drug|Cyclophosphamide|
12057773|NCT00131027|Drug|Daunorubicin|
12057774|NCT00131027|Drug|Vincristine|
12057775|NCT00131027|Drug|Prednisolone|
12057776|NCT00131027|Drug|L-asparaginase|
12057777|NCT00131027|Drug|Cytarabine|
12057778|NCT00131027|Drug|Etoposide|
12057779|NCT00131027|Drug|Dexamethasone|
12057780|NCT00131027|Drug|Methotrexate|3 g/sqm (high dose)
12057781|NCT00131027|Drug|Mercaptopurine|
12057782|NCT00131027|Drug|Doxorubicin|
12057783|NCT00131027|Drug|Methotrexate|0.5 g/sqm (intermediate dose)
12057784|NCT00131001|Procedure|contrast-enhanced magnetic resonance angiography|
12057785|NCT00130988|Behavioral|DEPENAS cognitive and behavioural techniques|
12057786|NCT00130975|Drug|Candesartan|
12057787|NCT00130962|Drug|ALGRX 4975|
12057788|NCT00130949|Drug|ALGRX 4975|
12057789|NCT00130936|Drug|Epirubicin|
12057790|NCT00130936|Drug|Carboplatin|
12057791|NCT00130936|Drug|Capecitabine|
12057792|NCT00130923|Drug|Risperidone Long Acting|Dose 25.00, 37.50 or 50.00 mg q two weeks
12057793|NCT00130923|Drug|oral risperidone|0.50-6.00 mg oral risperidone daily
12057794|NCT00130910|Drug|Albendazole|Albendazole 400mg x 3 first dose observed
12057795|NCT00130910|Drug|Placebo|Albendazole Placebo 400mg x 3 first dose observed
12057796|NCT00130897|Drug|Sutent|Sutent, 25, 37.5. or 50 mg daily
12057797|NCT00130884|Drug|levosimendan|
12057798|NCT00130871|Drug|levosimendan|
12057799|NCT00130858|Drug|Topotecan|
12057800|NCT00130858|Drug|Carboplatin|
12057801|NCT00130845|Drug|Octreotide Acetate in Microspheres|
12057802|NCT00130845|Drug|Placebo|
12057803|NCT00130832|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
12057804|NCT00130832|Biological|Comparator: Oral Poliovirus Vaccine (OPV)|Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
12057805|NCT00130832|Biological|Comparator: Oral Poliovirus Vaccine (OPV) (staggered)|Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
12057806|NCT00130819|Behavioral|Clinic-based substance abuse treatment with buprenorphine|Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
12057807|NCT00130819|Behavioral|Case management and referred substance abuse treatment|Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence
12057808|NCT00130806|Drug|MK0478 (muraglitazar)|
12057809|NCT00130806|Drug|Comparator: placebo|
12057810|NCT00130793|Biological|Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation|1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
12057811|NCT00130793|Biological|Comparator: zoster vaccine live (Oka/Merck) frozen formulation|1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
12057812|NCT00130780|Drug|Pre-surgical Treatment with Bevacizumab plus Chemotherapy|On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary.
12057813|NCT00130780|Drug|Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab|Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary.
12057814|NCT00130767|Drug|finasteride|
12057815|NCT00130754|Drug|Thymoglobuline|IV 7.5 mg/kg
12057816|NCT00130741|Drug|CHT - herbal therapy|
12057817|NCT00130728|Drug|bevacizumab|intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
12057818|NCT00130728|Drug|erlotinib HCl|oral erlotinib HCl 150 mg/day orally
12057819|NCT00130728|Drug|placebo|intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
12057824|NCT00130676|Drug|matching placebo|daily for 7 days
12057825|NCT00130663|Device|PDA blood pressure screening program and chart reminder|
12057826|NCT00130650|Device|Pain Ease|
12057827|NCT00130637|Drug|Daclizumab|
12057828|NCT00130624|Procedure|Multidisciplinary intervention: primary or secondary care|
12057829|NCT00130611|Other|BNP measurement|
12057830|NCT00130611|Other|Clinical examination|
12057831|NCT00130598|Drug|NaCl 0.9% i.v. or NaBic 1.4% i.v. or NaBic 1.4% i.v. + NaBic p.o. (Nephrotrans®)|"control group: preventive hydration with 154mEq/l saline at 1ml/kg per hour of 12 hours prior and after the procedure.
~7h-sodium bicarbonate: before contrast 3ml/kg NaHCO3 166mEq/l for one hour, followed by NaHCO3 166mEq/l (1ml/kg per hour until 6h after contrast).
~short-term sodium bicarbonate: NaHCO3 166mEq/l (3ml/kg) as a bolus 20 minutes before contrast; ingestion of Nephrotrans® (500mg NaHCO3/capsule: 1 capsule/10kg) with 1-2 dl non-sparkling mineral water at the start of the infusion. Ingestion of non-sparkling mineral water in the first 6 hours after contrast."
12057832|NCT00130585|Behavioral|Controlled diet|
12057833|NCT00130585|Behavioral|folic acid supplement|
12057834|NCT00130585|Behavioral|13C11-labelled folic acid supplement|
12057835|NCT00130572|Drug|Pimecrolimus|
12057836|NCT00130559|Procedure|BNP guided diagnostics and initial therapy|BNP guided diagnostics and initial therapy
12057837|NCT00130546|Device|Paclitaxel-eluting TAXUS(TM)|TAXUS(TM) Paclitaxel-eluting stent
12057838|NCT00130546|Device|Sirolimus eluting Cypher Select(TM)|Sirolimus eluting Cypher Select(TM) stent
12057839|NCT00130533|Drug|Capecitabine|
12057840|NCT00130520|Drug|bevacizumab|10mg/kg every two weeks IV-bevacizumab
12057841|NCT00130520|Drug|erlotinib|150mg daily by mouth-erlotinib
12057842|NCT00130507|Drug|Vinorelbine|
12057843|NCT00130507|Drug|Capecitabine|
12057844|NCT00130507|Drug|Trastuzumab|
12057845|NCT00130494|Drug|Zoledronic acid|
12057846|NCT00130481|Drug|Atorvastatin 20 mg daily for 3 months|
12057847|NCT00130468|Drug|Hyalgan (sodium hyaluronate)|
12057848|NCT00130455|Drug|escitalopram|
12057849|NCT00130442|Drug|PI-88 and dacarbazine|190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion
12057850|NCT00130442|Drug|dacarbazine or DTIC|intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
12057851|NCT00130429|Drug|PYM50028|
12057852|NCT00130416|Behavioral|E-mail coaching to improve patient communication with doctor|
12057853|NCT00130403|Drug|risedronate sodium|
12057854|NCT00130390|Drug|Nitazoxanide|One nitazoxanide 500 mg tablet twice daily for 28 days
12057855|NCT00130390|Other|Placebo|One placebo tablet twice daily for 28 days
12057856|NCT00130377|Biological|cell therapy|autologous or allogeneic cells
12057857|NCT00130364|Drug|Pimecrolimus|Pimecrolimus 1 % cream
12057858|NCT00130364|Drug|Placebo|Pimecrolimus vehicle cream (placebo)
12057859|NCT00130351|Device|formoterol|
12057860|NCT00130338|Drug|Rivastigmine|
12057861|NCT00130325|Drug|Isoniazid|Isoniazid 900mg, tablets, twice a week for 6 months
12057862|NCT00130325|Drug|Isoniazid|INH 900mg twice weekly for 6 months
12057863|NCT00130325|Drug|Placebo of Isoniazid tablets 300mg|Isoniazid BP 0mg twice weekly for 6 months
12057864|NCT00130312|Drug|Sulodexide|
12057865|NCT00130299|Behavioral|low glycemic load diet|
12057866|NCT00130299|Behavioral|low fat diet|
12057867|NCT00130286|Drug|Rosiglitazone|4 mg tablet twice a day x 12 weeks (double-blind phase)
12057868|NCT00130286|Drug|Recombinant human growth hormone + rosiglitazone|Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
12057869|NCT00130273|Behavioral|Managed problem solving|Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
12057870|NCT00130273|Behavioral|Standard care|Participants will receive standard of care for 12 months.
12057871|NCT00130260|Biological|Staph aureus types 5 and 8 conjugate vaccine|each IM dose contains 200 mc total conjugate
12057872|NCT00130260|Biological|placebo|placebo to match StaphVAX
12057873|NCT00130247|Drug|Ethambutol|Mycobacteriostatic agent given to prevent emergence of drug resistance to other 1st line drugs; dosages are 15-25 milligram (mg)/ kilogram (kg)/day (d).
12057874|NCT00130247|Drug|Isoniazid|Hydrazide of isonicotininc acid; antimicrobial activity is limited to mycobacteria where it inhibits the synthesis of mycolic acids.
12057875|NCT00130247|Drug|Pyrazinamide|1st line bactericidal agent; dosages are 15-30 mg/kg/d, up to 2 grams (gm)/d.
12057876|NCT00130247|Drug|Rifampin|1st line bactericidal agent which inhibits deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase; dosages are 10 mg/kg/d (up to 600 mg/d).
12057877|NCT00130234|Drug|Xolair® (Omalizumab)|
12057878|NCT00130221|Drug|2% chlorhexidine gluconate impregnated cloth|
12057879|NCT00130208|Drug|Sulodexide|100 mg sulodexide gelcaps
12057880|NCT00130208|Drug|Placebo|0 mg gelcap
12057881|NCT00130195|Drug|imatinib|
12057882|NCT00130195|Drug|cyclophosphamide|
12057883|NCT00130195|Drug|daunorubicin|
12057884|NCT00130195|Drug|vincristine|
12057885|NCT00130195|Drug|prednisolone|
12057886|NCT00130195|Drug|methotrexate|
12057887|NCT00130195|Drug|cytarabine|
12057888|NCT00130195|Drug|dexamethasone|
12057889|NCT00130182|Drug|denufosol tetrasodium (INS37217)|
12057890|NCT00130169|Drug|E7974|Maximum Tolerated Dose defined as 0.35 mg/m^2 administered on Days 1 and 15 only of a 28-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.
12057891|NCT00130156|Drug|Bunazosin|Patients will be randomized to the add-on treatment with Bunazosin (Detantol-R) 3 mg once-daily after breakfast for a total of eight weeks.
12057892|NCT00130156|Drug|Doxazosin|Patients will be randomized to the add-on treatment with Doxazosin (Doxaben XL) 4 mg once-daily after breakfast for a total of eight weeks.
12057893|NCT00130156|Drug|Valsartin|After wash-out period, the eligible subjects will be treated with Valsartin (Diovan) 80 mg as the mono therapy for 5 weeks. If the blood pressures are inadequately responded, then the patients will be randomized to either Bunazosin (Detantol-R) or Doxazosin (Doxaben XL) along with Valsartin as the add-on treatment for 8 weeks.
12057894|NCT00130143|Drug|Ethyol (Amifostine)|
12057895|NCT00130117|Drug|r-metHuLeptin|Starting dose: 0.08mg/kg once daily Subcutaneous injection.
12057896|NCT00130117|Drug|Oral Contraceptive Pills (OCPs)|Sprintec taken orally once daily.
12057897|NCT00130117|Other|Placebo|placebo (no active medication)
12057898|NCT00130104|Procedure|Transthecal Metacarpal Block|
12057899|NCT00130091|Drug|clonidine|2 mcg clonidine added to local anesthetic
12057900|NCT00130078|Drug|1.0% C31G SAVVY vaginal gel|
12057901|NCT00130065|Drug|Sulfadoxine-pyrimethamine/folic acid|
12057902|NCT00130065|Drug|Sulfadoxine-pyrimethamine/placebo|
12057903|NCT00130039|Drug|clopidogrel|Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
12057904|NCT00130039|Drug|Cilostazol|Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
12057905|NCT00130026|Drug|Caffeine|500 mg IV
12057906|NCT00130013|Drug|Oral Amoxicillin|
12057907|NCT00130000|Drug|Eculizumab|
12057908|NCT00129987|Behavioral|Self management education|
12057909|NCT00129974|Drug|pemetrexed and gemcitabine|
12057910|NCT00129961|Drug|sirolimus|
12057911|NCT00129961|Drug|cyclosporine or tacrolimus|
12057912|NCT00129948|Drug|Troxatyl™ (troxacitabine)|
12057913|NCT00129935|Drug|Docetaxel|
12057914|NCT00129935|Drug|Capecitabine|
12057915|NCT00129935|Drug|Epirubicin|
12057916|NCT00129935|Drug|Cyclophosphamide|
12057917|NCT00129922|Drug|paclitaxel|
12057918|NCT00129922|Drug|Fluorouracil|
12057919|NCT00129922|Drug|Epirubicin|
12057920|NCT00129922|Drug|Cyclophosphamide|
12057921|NCT00129909|Drug|fixed dose combination therapy|
12057922|NCT00129896|Drug|Myocet|Myocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
12057923|NCT00129896|Drug|Taxotere|Taxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
12057924|NCT00129896|Drug|Herceptin|Herceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles
12057925|NCT00129883|Behavioral|Professional education|
12057926|NCT00129883|Behavioral|Implementation of a Critical Care Pathway|
12057927|NCT00129883|Behavioral|Professional audit and feedback|
12057928|NCT00129883|Behavioral|Process analysis and redesign|
12057929|NCT00129870|Drug|oxaliplatin|
12057930|NCT00129857|Drug|Dexanabinol|
12057931|NCT00129844|Drug|Motexafin Gadolinium|
12057932|NCT00129831|Drug|QAB149|
12057933|NCT00129818|Drug|Famciclovir|
12057934|NCT00129805|Drug|MCI-9042|
12057935|NCT00129805|Drug|Aspirin|
12057936|NCT00129792|Drug|Dietary supplement for weight loss|The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
12057937|NCT00129792|Behavioral|Education and counseling for weight loss|Hour and a half weight loss education session weekly for 12 weeks.
12057938|NCT00129779|Behavioral|Intermediate care package|
12057939|NCT00129766|Biological|motavizumab (MEDI-524)|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
12057940|NCT00129766|Biological|palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
12057941|NCT00129753|Drug|Alemtuzumab (Campath-1H)|Escalating dose 3mg, 10 mg, 30 mg on three consecutive days, then 30 mg three times per week by subcutaneous injections for 12 weeks. Each 30 mg dose will be divided in 2 injections to be administered in each thigh.
12057942|NCT00129740|Drug|Nilotinib|400 mg orally twice daily
12057943|NCT00129727|Drug|Paclitaxel|Given intravenously
12057944|NCT00129727|Drug|Carboplatin|Given intravenously
12057945|NCT00129727|Drug|Bevacizumab|Given intravenously
12057946|NCT00129714|Other|cervical collar|
12057947|NCT00129714|Other|physiotherapy|
12057948|NCT00129701|Procedure|Telephone consultation|
12057949|NCT00129688|Drug|cloxacillin and amikacin (once or twice daily dosage)|
12057950|NCT00129675|Drug|[123I]ß CIT|"Single Photon Emission Computed Tomography
~SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI."
12057951|NCT00129662|Behavioral|Pictorial action plan|
12057952|NCT00129649|Behavioral|Telephone reminder call|
12057953|NCT00129636|Procedure|Additional specific letter written to patient|
12057954|NCT00129623|Drug|Placebo|po monthly for 1 year
12057955|NCT00129623|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 1 year
12057956|NCT00129610|Behavioral|Virtual Reality Therapy|
12057957|NCT00129610|Behavioral|Cognitive Behavior Therapy|
12057958|NCT00129597|Drug|ketalar|
12057959|NCT00129584|Procedure|Emphasys Endobronchial Valve and procedure|
12057960|NCT00129571|Drug|XL820|
12057961|NCT00129558|Drug|PT-523 for Injection|
12057962|NCT00129545|Device|WATCHMAN Left Atrial Appendage Closure Technology|Implant of WATCHMAN Left Atrial Appendage Closure Technology
12057963|NCT00129545|Drug|Warfarin|Subjects receive warfarin
12057964|NCT00129532|Drug|1.0% C31G SAVVY vaginal gel|
12057965|NCT00129519|Drug|Imiquimod 5% cream|Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks
12057966|NCT00129506|Drug|methotrexate + misoprostol|
12057967|NCT00129506|Drug|misoprostol|
12057968|NCT00129493|Behavioral|Group medical visits|Our intervention aims to develop and implement a model of group medical visits in iterative steps, to evaluate whether group medical visits improve patient adherence to prescribed antihypertensive medications and improve BP control, and to assess patient, physician, and health care system factors involved in successfully making organizational changes to encompass group medical visits.
12057969|NCT00129480|Behavioral|Assistance with Pain treatment|Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.
12057970|NCT00129467|Drug|Methylphenidate|"Subjects will take methylphenidate 5 mg twice daily (bid) for 3 days, then 10 mg bid for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of methylphenidate, they will be maintained at that lower dose as long as their MADRS score remains reduced by 50%. During the 18-day blinded treatment period the total daily dose will not exceed 20 mg.
~If subjects have side effects when increasing to 10 mg bid, they will drop back to 5 mg bid. If the participant develops psychosis or cardiac events, they will be discontinued from methylphenidate.
~Subjects who receive methylphenidate and respond with a 50% reduction in MADRS score will have the option to continue in the open label portion of the study for up to 6 weeks. For patients taking methylphenidate 10 mg bid whose MADRS score is > 10 at day 18, the dose may be increased to 15 mg bid."
12057971|NCT00129467|Drug|Placebo|"Subjects assigned to placebo will receive 1 capsule of placebo twice per day (bid) for 3 days and then 2 capsules bid for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of placebo, they will be maintained at that lower dose as long as their MADRS score remains reduced by 50%.
~If subjects have side effects when increasing the dose to 2 capsules bid, they will drop back to 1 capsule bid. If the participant develops psychosis or cardiac events, they will be discontinued from the intervention."
12057972|NCT00129467|Drug|Selective Serotonin Uptake Inhibitor (SSRI)|"Each subject will be treated with a SSRI. Patients who are taking an SSRI at the time of enrollment will continue on the same medication during the 18-day blind treatment period. The prescribed dose will only be adjusted if it is more than the highest dose in the recommended range (fluoxetine to 40 mg, paroxetine to 40 mg, citalopram to 40 mg, sertraline to 150 mg). Patients who are not on a SSRI at the time of enrollment will be prescribed citalopram 10 mg per day for 2 weeks, then 20 mg per day.
~A subject's SSRI may be discontinued if the subject experiences moderate to severe side effects likely attributable to a SSRI. If subjects experience similar symptoms when increasing their citalopram dose to 20 mg per day, they will drop back to 10 mg per day. During the open label extension, the SSRI may be increased, decreased, or changed to a different SSRI or other antidepressant with the exception of venlafaxine and bupropion"
12057973|NCT00129454|Behavioral|Cognitive Behavioral Therapy|"The investigators adapted two previously validated CBT manuals for use in both Telephone and In-Person groups (the Personal Health Improvement Program and Dr. Charles Engel's group treatment for GWI). Treatment included the following standard components of CBT: Didactic or educational material about the causes of GWI and an explanation of how thinking can cause stress (ABC model); Assessment of psychological distress and behavioral problems that may be targets of therapeutic intervention (e.g. symptom-related anxiety); Assessment of thinking errors that lead to psychological distress and trigger behavioral problems (e.g. catastrophizing); Cognitive restructuring to teach disputing skills or how to correct thinking errors; Cognitive and behavioral homework assignments (e.g. written self-disclosure); Didactic homework assignments (e.g. listen to previous treatment session)."
12057974|NCT00129454|Behavioral|Cognitive Behavioral Therapy|This description is the same as the experimental treatment only disseminated in person rather than over the telephone.
12057975|NCT00129441|Drug|Merck L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
12057976|NCT00129441|Drug|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
12057977|NCT00129428|Procedure|UVB Irradiation|A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.
12057978|NCT00129415|Procedure|UVA1 Irradiation|The affected areas on the body will be treated with UVA1 (Sellemed UVA1 light source) for up to 5 times per week for 16 weeks. The UVA1 dose will be up to 130 J/cm2.
12057979|NCT00129415|Procedure|UVB Irradiation|The affected areas on the body will be treated with UVB light for up to 5 times per week for 16 weeks. The maximum UVB dose will be 4000 mJ/cm2.
12057980|NCT00129402|Drug|ezetimibe with simvastatin|Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks
12057981|NCT00129402|Drug|simvastatin|Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks
12057982|NCT00129389|Drug|Fluorouracil|Arm A: FAC Arm B: FAC-wP
12057983|NCT00129389|Drug|Doxorubicin|Arm A: FAC Arm B: FAC-wP
12057984|NCT00129389|Drug|Cyclophosphamide|Arm A: FAC Arm B: FAC-wP
12057985|NCT00129389|Drug|Paclitaxel|Arm B: FAC-wP
12057986|NCT00129376|Drug|Doxorubicin|
12057987|NCT00129376|Drug|Cyclophosphamide|
12057988|NCT00129376|Drug|Docetaxel|
12057989|NCT00129363|Drug|Carvedilol|
12057990|NCT00129350|Procedure|Pulmonary rehabilitation programme|
12057991|NCT00129337|Drug|Bavituximab|Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
12057992|NCT00129324|Procedure|Lead Hazard Control Intervention|Prior to their child's birth, participants randomized to Lead Reduction Group received lead hazard reduction controls to reduce residential exposure to lead.
12057993|NCT00129324|Procedure|Injury Hazard Control Intervention|Between 3 and 6 months of age, participants randomized to Injury Reduction Arm received injury hazard controls to reduce the number of residential injuries.
12057994|NCT00129311|Drug|Selegiline|5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
12057995|NCT00129311|Drug|Placebo|
12057996|NCT00129298|Drug|Tiagabine|The tiagabine group will start receiving tiagabine 4mg in the evening of the first day on week 2. The dose will be titrated every third day, until the target dose of 32mg/day is achieved by week 5. The study medication must be titrated to 32 mg/day or to the subject's maximum tolerated dose (MTD).
12057997|NCT00129285|Drug|Low Dose Modafinil|modafinil 200 mg/day
12057998|NCT00129285|Drug|High Dose Modafinil|modafinil 400 mg/day
12057999|NCT00129285|Drug|Placebo|placebo 400 mg/day
12058000|NCT00129272|Drug|Bupropion-SR|150mg tablets taken orally twice daily for 9 weeks.
12058001|NCT00129272|Other|Placebo|Matching placebo (to Buproion-SR) twice daily for 9 weeks.
12058002|NCT00129259|Biological|Anti-CD3 mAb|Daily 14-day dose escalation course at study entry, with possible second course after 12-month interval
12058003|NCT00129259|Other|Diabetes Standard of Care Treatment|Receipt of intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
12058004|NCT00129259|Dietary Supplement|Iron supplementation|Immediately following randomization, all participants regardless of arm allocation begin iron supplementation with either ferrous sulfate or multivitamin with iron.
12058005|NCT00129246|Drug|Naltrexone|Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
12058006|NCT00129246|Drug|Bupropion|Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
12058007|NCT00129233|Drug|Valsartan|valsartan 80 to 160 mg daily
12058008|NCT00129233|Drug|Amlodipine|Amlodipine 5 to 10 mg daily.
12058009|NCT00129220|Drug|olanzapine|5-20 mg, oral, once daily (evening), for 6 weeks
12058010|NCT00129220|Drug|haloperidol|2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.
12058011|NCT00129220|Drug|placebo|placebo, oral tablets, twice daily (morning and evening), for 3 weeks
12058012|NCT00129207|Drug|bortezomib|
12058013|NCT00129194|Drug|KP-1461|
12058014|NCT00129181|Drug|cabergoline|Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
12058015|NCT00129181|Drug|carbidopa/levodopa|Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
12058016|NCT00129181|Procedure|DATscan and SPECT imaging|Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
12058017|NCT00129168|Drug|Zosuquidar|
12058018|NCT00129168|Drug|Daunorubicin|
12058019|NCT00129168|Drug|Cytarabine|
12058020|NCT00129155|Drug|treosulfan|
12058021|NCT00129142|Drug|Toremifene Citrate|
12058022|NCT00129129|Biological|GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine|Primary phase: 3 IM doses Booster phase: 1 IM dose
12058023|NCT00129129|Biological|ActHIB|Primary phase: 3 IM doses Booster phase: 1 IM dose
12058024|NCT00129129|Biological|Pediarix|Primary phase: 3 IM doses
12058025|NCT00129129|Biological|Prevnar|Primary phase: 3 IM doses Booster phase: 1 IM dose
12058026|NCT00129129|Biological|Menomune|Primary phase: 1 SC dose
12058027|NCT00129116|Biological|Hib-MenCY-TT vaccine|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
12058028|NCT00129116|Biological|Hib-MenC-TT vaccine|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
12058029|NCT00129116|Biological|Menjugate ®|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
12058030|NCT00129116|Biological|Infanrix penta ®|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
12058031|NCT00129116|Biological|Infanrix hexa ®|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
12058032|NCT00129090|Drug|R-CHOEP 14 with 12x Rituximab|after amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle)
12058033|NCT00129077|Procedure|plastic wrap over eye & lubrication applied q6 hrs|
12058034|NCT00129064|Behavioral|Electronic referral system|
12058035|NCT00129051|Procedure|Tomotherapy|
12058036|NCT00129038|Drug|modified-release dipyridamole/aspirin|
12058037|NCT00129038|Drug|aspirin|
12058038|NCT00129025|Procedure|Hypofractionated radiotherapy|
12058039|NCT00129012|Procedure|Tomotherapy|
12058040|NCT00128999|Procedure|Intensity-Modulated Radiation Therapy|
12058041|NCT00128986|Procedure|Tomotherapy|3T MRS scans (3T magnetic resonance spectroscopy)
12058042|NCT00128947|Drug|Mycophenolic Acid|
12058043|NCT00128947|Drug|Mycophenolate 7-O-Phenolic Glucuronide|
12058044|NCT00128934|Drug|levonorgestrel/ethinyl estradiol|
12058045|NCT00128921|Drug|VELCADE™|"Patients will receive two cycles of VELCADE™ (1.3 mg/m2, 1.0 mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21 day cycle. No growth factors or bisphosphonates will be allowed during study treatment. Bone markers will be measured:
~Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2-4 hours for 8 hours Days 2-3, 5-7, 9-10, 12-21: every 24 hours, beginning with the immediate post-dose sample (+/- 2 hours) Other laboratory and radiologic studies will be performed as detailed in the Study Calendar.
~Patients will complete the study after two cycles of VELCADE™. However, if a patient continues to receive VELCADE™ as part of his/her treatment for relapsing MM, routine bone markers may be monitored for the duration of VELCADE™ treatment as clinically indicated."
12058046|NCT00128908|Drug|Standard Continuous Highly Active Antiretroviral Therapy (HAART)|
12058047|NCT00128908|Drug|Rapidly Cycled HAART|
12058048|NCT00128895|Drug|azathioprine|azathioprine 2 mg/kg oral once daily, duration according to arm
12058049|NCT00128882|Drug|Anti-D|Subcutaneous injection
12058050|NCT00128869|Procedure|spine mobilizations|
12058051|NCT00128869|Procedure|spine manipulations|
12058052|NCT00128856|Drug|Gemcitabine|
12058053|NCT00128856|Drug|Adriamycine|
12058054|NCT00128856|Drug|Paclitaxel|
12058055|NCT00128843|Drug|Exemestane|25mg/day until progression disease
12058056|NCT00128843|Drug|Anastrozole|1mg/day until progression disease
12058057|NCT00128830|Drug|Etravirine (ETR)|Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available.
12058058|NCT00128830|Drug|Nucleotide reverse transcriptase inhibitors (NRTIs)|Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
12058059|NCT00128830|Drug|Protease inhibitors (PIs)|Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
12058060|NCT00128830|Drug|Enfuvirtide (ENF)|Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
12058061|NCT00128817|Radiation|Concurrent Chemoradiation|60-70 Gy at 2Gy/5days a week for 6 to 7 weeks Cisplatin (CDDP) 100 mg/m2 over 20-30 minutes on days 1, 22, and 43.
12058062|NCT00128817|Procedure|Laryngectomy + adjuvant radiotherapy/chemoradiotherapy|Surgery: Total Laryngectomy with or without partial pharyngectomy or Near-Total Laryngectomy with or wothout partial pharyngectomy Adjuvant Radiation 2- 3 weeks following surgery: 50-60Gy at 2Gy/5days a week for 5 to 6 weeks Cisplatin (CDDP) 100 mg/m2 over 20-30 minutes on days 1, 22, and 43.
12058063|NCT00128804|Behavioral|absorption and conversion of beta-carotene in human gastrointestinal (GI) tract|
12058064|NCT00128791|Drug|Nitroprusside|
12058065|NCT00128778|Drug|Pegylated liposomal doxorubicin|
12058066|NCT00128765|Behavioral|an integrated self-management education program|disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
12058067|NCT00128765|Behavioral|regular practice nurse review (monitoring controls)|protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
12058068|NCT00128765|Behavioral|care at initiative of the patient (usual GP care)|care at initiative of the patient (usual GP care)
12058069|NCT00128752|Behavioral|absorption and conversion of beta-carotene in human gastrointestinal (GI) tract|
12058070|NCT00128739|Drug|Budesonide|
12058071|NCT00128713|Procedure|Medium Dose Prophylactic Platelet Transfusions|2.2 x 10^11 platelets per m^2 BSA
12058072|NCT00128713|Procedure|Lower Dose Prophylactic Platelet Transfusions|1.1 x 10^11 platelets per m^2 BSA
12058073|NCT00128713|Procedure|Higher Dose Prophylactic Platelet Transfusions|4.4 * 10^11 platelets per m^2 BSA
12058074|NCT00128700|Drug|temozolomide|
12058075|NCT00128700|Drug|vatalanib|
12058076|NCT00128700|Procedure|adjuvant therapy|
12058077|NCT00128700|Radiation|radiation therapy|
12058078|NCT00128687|Behavioral|risk reduction|Participants receive intensive case management for CHD risk reduction for 15 months and then a maintenance program for a minimum of 12 months. Lifestyle modification was strongly emphasized as a critical component of achieving CHD prevention goals. Dietary management was emphasized, including recommendation of a low saturated fat (less than 7% of caloric intake), low cholesterol (< 150 mg/day), mainly plant-based diet with calorie restrictions for overweight/obese persons. Stress management and coping skills were emphasized, including a regular exercise regimen (≥ 30 minutes of moderate intensity on most days). Cigarette smokers were encouraged to join a stop smoking program.
12058079|NCT00128661|Biological|human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine|Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule
12058080|NCT00128661|Biological|hepatitis A inactivated virus vaccine|Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule
12058081|NCT00128635|Radiation|iodine I 131 monoclonal antibody TNT-1/B|
12058082|NCT00128622|Biological|denileukin diftitox|
12058083|NCT00128622|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|
12058084|NCT00128622|Biological|therapeutic autologous dendritic cells|
12058085|NCT00128596|Drug|arsenic trioxide|
12058086|NCT00128583|Biological|polyvalent melanoma vaccine|
12058087|NCT00128570|Behavioral|behavioral dietary intervention|
12058088|NCT00128570|Other|educational intervention|
12058089|NCT00128570|Other|internet-based intervention|
12058090|NCT00128570|Other|preventative dietary intervention|
12058091|NCT00128570|Procedure|evaluation of cancer risk factors|
12058092|NCT00128557|Drug|vitamin A supplementation (50,000 IU)|
12058093|NCT00128544|Drug|telbivudine|
12058094|NCT00128544|Drug|valtorcitabine|
12058095|NCT00128531|Drug|leuprolide acetate|
12058096|NCT00128518|Drug|Indapamide (T2)|1.5 mg/day during 4 weeks
12058097|NCT00128518|Drug|Perindopril (T1)|4 mg/day during 1 week then 8 mg/day during 3 weeks
12058170|NCT00127998|Drug|mefloquine|
12058098|NCT00128518|Drug|Placebo of Perindopril (P1)|1 pill/day during 1 week then 2 pills/day during 3 weeks
12058099|NCT00128518|Drug|Placebo of Indapamide (P2)|1 pill/day during 4 weeks
12058100|NCT00128505|Drug|Mifepristone|
12058101|NCT00128492|Drug|AZLI 75 mg two times a day (BID)/ three times a day (TID)|
12058102|NCT00128479|Drug|mifepristone|mifepristone 300 mg daily for 7 dats
12058103|NCT00128479|Drug|mifepristone matched placebo|daily for 7 days
12058104|NCT00128479|Drug|mifepristone 600 mg|mifepristone 600 mg daily for 7 days
12058105|NCT00128479|Drug|mifepristone 1200 mg|mifepristone 1200 mg daily for 7 days
12058106|NCT00128466|Drug|gentamicin|
12058107|NCT00128466|Drug|streptomycin|
12058108|NCT00128453|Drug|Colchicine (for 3 months)|Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily
12058109|NCT00128453|Drug|Placebo|placebo
12058110|NCT00128440|Drug|BEA 2180 BR|
12058111|NCT00128440|Drug|tiotropium|
12058112|NCT00128427|Drug|Colchicine (for 1 month)|
12058113|NCT00128414|Drug|Colchicine (for 6 months)|colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.
12058114|NCT00128414|Drug|Placebo|Tablets identical in colour, shape, and taste were provided in blister packs.
12058115|NCT00128401|Drug|D-Cycloserine|
12058116|NCT00128401|Drug|Placebo|
12058117|NCT00128388|Other|PFPP|Psychoanalytic Psychotherapy for panic disorder
12058118|NCT00128388|Other|ART|Applied Relaxation Training
12058119|NCT00128375|Behavioral|Financial incentives|
12058120|NCT00128362|Procedure|Radio-guided sentinel node biopsy|
12058121|NCT00128362|Procedure|Axillary sampling|
12058122|NCT00128336|Behavioral|Lifestyle: diet and exercise intervention|
12058123|NCT00128323|Drug|Gentian violet 1% solution|
12058124|NCT00128323|Drug|Gentian violet 0.00165% solution|
12058125|NCT00128323|Drug|Nystatin solution|
12058126|NCT00128310|Drug|Vinorelbine|
12058127|NCT00128310|Drug|Gemcitabine|
12058128|NCT00128297|Drug|Pamidronate|
12058129|NCT00128271|Drug|Bavituximab|
12058130|NCT00128258|Procedure|Injection of bone marrow cells in the heart|Biological implant into the heart
12058131|NCT00128258|Biological|Biological bone marrow cell therapy|Biological implant into the heart
12058132|NCT00128245|Drug|Pimecrolimus|
12058133|NCT00128245|Drug|Vehicle|Placebo
12058134|NCT00128232|Drug|Octreotide LAR|
12058135|NCT00128219|Biological|GBS III-TT|50 mcg GBS Type III capsular polysaccharide conjugated to 32 mcg of tetanus toxoid. A single dose of vaccine administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml.
12058136|NCT00128219|Biological|Tetanus and diptheria toxoids vaccine|Td vaccine is a sterile solution of alum-precipitated toxoids in isotonic sodium chloride solution. A single dose of vaccine will be administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml. Each 0.5 ml dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and 2 Lf of diphtheria toxoid.
12058137|NCT00128206|Drug|Isoniazid|Isoniazid 900 mg twice weekly
12058138|NCT00128206|Drug|Rifampin|Rifampin 600mg once per day
12058139|NCT00128193|Biological|Tuberculin, Purified Protein Derivative|A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose
12058140|NCT00128193|Other|MLSA-LAM|Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
12058141|NCT00128193|Other|MLCwA|Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
12058142|NCT00128193|Biological|Tuberculin, Purified Protein Derivative|Licensed TB reagent, 100 microliters, 5 TU dose.
12058143|NCT00128193|Other|Placebo|Saline (NaCl) serves as a diluent control in Stage A and B only.
12058144|NCT00128180|Drug|Methylprednisolone|Intravenous methylprednisolone 16 mg/kg/day for 3 days as follows: 8 mg/kg (up to 500 mg) given over first hour followed by 8 mg/kg over the next 23 hours; then 16 mg/kg (up to 1000 mg) on days 2 and 3 administered over 24 hours.
12058145|NCT00128180|Drug|Placebo|Placebo
12058146|NCT00128167|Drug|Liquid CAIV-T|
12058147|NCT00128154|Drug|Chromium picolinate|
12058148|NCT00128141|Behavioral|Tactile stimulus|four times a day
12058149|NCT00128128|Drug|Cranberry juice cocktail|Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
12058150|NCT00128115|Drug|MK0677|
12058151|NCT00128102|Drug|Vorinostat|Vorinostat 100 mg oral capsules
12058152|NCT00128102|Drug|Placebo|Vorinostat-matching placebo oral capsules
12058153|NCT00128089|Behavioral|Dietary treatment|
12058154|NCT00128076|Procedure|All-Arthroscopic repair|joint techniques and repair are both performed entirely through the arthroscope
12058155|NCT00128076|Procedure|Mini-open repair|repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)
12058156|NCT00128063|Drug|succinylated human serum albumin|
12058157|NCT00128050|Drug|rFactor VIIa (Eptacog alfa, NovoNordisk)|rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.
12058158|NCT00128050|Drug|rFVIIa|Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation
12058159|NCT00128050|Other|Sodiun chloride 0.9%|Bolus injection of sodium chloride 0.9% after surgical hematoma removal
12058160|NCT00128037|Drug|mitomycin C, vindesine, cisplatin and radiotherapy|
12058161|NCT00128024|Drug|lipid-lowering treatment|
12058162|NCT00128011|Biological|killed oral cholera vaccine|
12058163|NCT00127998|Drug|chloroquine|
12058164|NCT00127998|Drug|sulfadoxine-pyrimethamine|
12058165|NCT00127998|Drug|amodiaquine|
12058166|NCT00127998|Drug|amodiaquine+artesunate|
12058167|NCT00127998|Drug|amodiaquine+sulfadoxine-pyrimethamine|
12058168|NCT00127998|Drug|sulfadoxine-pyrimethamine+artesunate|
12058169|NCT00127998|Drug|artemether-lumefantrine|
12058171|NCT00127985|Drug|6-methyl-prednisolone|iv, 2 mg/kg/day, qid
12058172|NCT00127972|Drug|stavudine|
12058173|NCT00127972|Drug|lamivudine|
12058174|NCT00127972|Drug|nevirapine|
12058175|NCT00127972|Drug|efavirenz|
12058176|NCT00127972|Drug|trizivir|
12058177|NCT00127959|Drug|tenofovir|
12058178|NCT00127959|Drug|emtricitabine|
12058179|NCT00127959|Drug|zidovudine|
12058180|NCT00127959|Drug|efavirenz|
12058181|NCT00127946|Procedure|AMNIOECHANGE|The AMNIOECHANGE consists of a transabdominal infusion of saline (heated to 37 ° C) with a needle 18 or 20 gauge under ultrasound monitoring while avoiding the placenta. In the case of a normal amniotic fluid, it must be replaced volume per volume of saline (eg depending on the tank where the puncture is made, it can be 300 per 300 ml). The total amount of amniotic fluid exchange is 600-900 ml. In cases of oligohydramnios, the AMNIOECHANGE results in a normalized volume of amniotic fluid.
12058182|NCT00127933|Drug|capecitabine [Xeloda]|825mg/m2 po bid on days 1-14 of each 3 week cycle
12058183|NCT00127933|Drug|Taxotere|75mg/m2 iv on day 1 of each 3 week cycle
12058184|NCT00127933|Drug|Herceptin (HER2-neu positive patients only)|4mg/kg iv (loading dose) followed by 2mg/kg iv weekly
12058185|NCT00127933|Drug|capecitabine [Xeloda]|825mg/m2 po bid on days 1-14 of each 3 week cycle
12058186|NCT00127933|Drug|Taxotere|75mg/m2 iv on day 1 of each 3 week cycle
12058187|NCT00127920|Drug|Avastin|Paclitaxel, Carboplatin and Avastin given on day 1 every 21 days
12058188|NCT00127907|Drug|epinephrine (1 mg/1 mL)|
12058189|NCT00127907|Drug|arginine-vasopressin (40 UI/2 mL)|
12058190|NCT00127881|Drug|HuMax-CD4 (zanolimumab)|Monoclonal Antibody, 12 weekly infusions.
12058191|NCT00127868|Drug|oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo|
12058192|NCT00127855|Biological|Hib-MenCY-TT vaccine (MenHibrix)|Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
12058193|NCT00127855|Biological|Meningitec®|Three doses were administered IM in right lower thigh at Months 0,2 and 4.
12058194|NCT00127855|Biological|ActHIB®|Three doses were administered IM in left thigh at Months 0,2 and 4.
12058195|NCT00127855|Biological|Infanrix® Penta|Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
12058196|NCT00127855|Biological|Prevenar®|Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
12058197|NCT00127855|Biological|Mencevax® ACWY|One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
12058198|NCT00127855|Biological|PRP (Polyribosyl Ribitol Phosphate)|One dose was administered IM in deltoid region of left arm at Month 10 as booster.
12058199|NCT00127842|Drug|Etanercept|Administered according to the product monograph by subcutaneous (SC) injection
12058200|NCT00127829|Drug|Gefitinib|Oral tablet
12058201|NCT00127816|Procedure|Permanent prostate implant|
12058202|NCT00127803|Biological|Placebo (vaccine diluent)|0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
12058203|NCT00127803|Biological|Clostridium difficile vaccine|0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
12058204|NCT00127803|Biological|Clostridium difficile vaccine|0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
12058205|NCT00127803|Biological|Clostridium difficile vaccine|0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
12058206|NCT00127790|Behavioral|CBT for Insomnia (CBT-I)|
12058207|NCT00127790|Behavioral|CBT for Pain (CBT-P)|
12058208|NCT00127777|Drug|Amantadine sulphate (in addition to standard treatment)|
12058209|NCT00127764|Drug|dexamethasone (50mg 1dd6, 3 consecutive days/month)|
12058210|NCT00127751|Behavioral|Enhance health lifestyle changes and medication compliance|
12058211|NCT00127738|Procedure|Angiographic renal revascularization|
12058212|NCT00127725|Device|Pulsed electromagnetic field stimulation|
12058213|NCT00127712|Drug|Amiodarone|
12058214|NCT00127699|Procedure|Alcohol swab of umbilical cord|
12058215|NCT00127686|Drug|Dextromethorphan|
12058216|NCT00127686|Drug|Buckwheat Honey|
12058217|NCT00127673|Drug|Sertraline|The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
12058218|NCT00127673|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
12058219|NCT00127660|Behavioral|Menu: calories=yes, value pricing=no|
12058220|NCT00127660|Behavioral|Menu: calories=yes, value pricing = yes|
12058221|NCT00127660|Behavioral|Menu: calories=no, value pricing = no|
12058222|NCT00127647|Drug|montelukast sodium|montelukast sodium; 5 mg, 10 mg QD 2-weeks.
12058223|NCT00127647|Drug|Comparator: pranlukast|Pranlukast 225 mg BID 2-weeks.
12058224|NCT00127634|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 24 months, up to 36 months
12058225|NCT00127634|Drug|Injectable Insulin|patient specific dose, injectable, before meals, 24 months, up to 36 months.
12058226|NCT00127634|Drug|Insulin Glargine|patient specific dose, injectable, as needed, 24 months up to 36 months
12058227|NCT00127621|Procedure|early tracheotomy|
12058228|NCT00127621|Procedure|prolonged endotracheal intubation|
12058229|NCT00127608|Procedure|Collection of clinical samples|"The following samples were obtained from each subject:
~Vesicle fluid (VF) and vesicle swabs (VS) from four vesicles (for a total of eight samples)
~Papule swabs (PS) from four papules
~Crusts from two lesions
~One throat swab (TS) Up to 15 samples were to be obtained for each subject, when possible. VFs, VSs, PSs, and crusts were either stored dry or in liquid medium. TS samples were stored in liquid medium.
~After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique."
12058230|NCT00127595|Drug|gemcitabine, oxaliplatin|
12058231|NCT00127582|Procedure|Electrophysiological study|
12058232|NCT00127582|Device|pacemaker (PM) implant, internal cardiac defibrillator (ICD) implant, loop-recorder implant|
12058233|NCT00127569|Drug|Rituximab|
12058234|NCT00127556|Procedure|Label applied to blood bag|
12058235|NCT00127543|Behavioral|Medication Education for Children|
12058236|NCT00127530|Drug|Fampridine-SR|Tablets, 10 mg, twice daily, 14 weeks
12058237|NCT00127530|Drug|Placebo|sugar pill, twice a day (b.i.d.)
12058238|NCT00127517|Drug|peptide-nucleic acid solution AVR118|
12058239|NCT00127504|Drug|Rifampin|
12058240|NCT00127504|Drug|Azithromycin|
12058241|NCT00127491|Procedure|Placement of an esophageal balloon measurements|In both groups an esophageal balloon will be placed and baseline measurements recorded. In the EP group the mechanical ventilation settings will be determined based on these measurements. In the control group measurements will be recorded but ventilation will be based in the existing standard of care wich is the ARDSnet low tidal volume ventilation study. measurements will be repeated at 24, 48 and 72 hours or as needed.
12058242|NCT00127491|Other|Low tidal volume ventilation|Low tidal volume ventilation strategy (ARDSnet)
12058243|NCT00127491|Other|Transpulmonary pressure-directed ventilation (EPVent)|Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.
12058244|NCT00127478|Drug|Atrasentan|
12058245|NCT00127465|Procedure|Issue of information booklet|
12058246|NCT00127452|Dietary Supplement|margarine spread|Daily use of margarine spread (approximately 20 grams) during 40 months
12058247|NCT00127439|Procedure|Manually Assisted Locomotor Training|The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
12058248|NCT00127439|Other|Robotic Assisted Locomotor Training|The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
12058249|NCT00127413|Behavioral|Cognitive Behavioral Therapy - Pain|Pain treatment
12058250|NCT00127413|Behavioral|Cognitive Behavioral Therapy-Integrated|Integrated treatment
12058251|NCT00127413|Behavioral|Cognitive Processing Therapy - PTSD|Cognitive processing therapy
12058252|NCT00127413|Behavioral|Treat as Usual|Treatment as usual
12058253|NCT00127400|Behavioral|anger management therapy|
12058254|NCT00127387|Drug|Enbrel|
12058255|NCT00127374|Behavioral|Dietary and physical activity modifications|
12058256|NCT00127361|Behavioral|doula training|
12058257|NCT00127348|Device|CPAP (Continuous Positive Airway Pressure)|
12058258|NCT00127335|Drug|cellulose placebo vs. atorvastatin|drug
12058259|NCT00127309|Drug|Glutathione|
12058260|NCT00127296|Device|FlexPen®|
12058261|NCT00127296|Device|vial and syringe|
12058262|NCT00127283|Drug|eptacog alfa (activated)|
12058263|NCT00127270|Drug|Darifenacin|Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
12058264|NCT00127270|Drug|Darifenacin|Darifenacin tablets 7,5 mg or 15 mg once daily
12058265|NCT00127270|Behavioral|Behavioral therapy|Behavioral Modification Programme for symptoms of overactive bladder
12058266|NCT00127257|Behavioral|Biofeedback|
12058267|NCT00127257|Drug|Diazepam|
12058268|NCT00127257|Behavioral|Pelvic floor retraining|
12058269|NCT00127244|Procedure|Periodontal Treatment|
12058270|NCT00127231|Behavioral|Brief alcohol intervention based on Project Treat|The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
12058271|NCT00127231|Behavioral|Standard care|Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
12058272|NCT00127218|Drug|any statin|Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months
12058273|NCT00127218|Drug|niacin|long-acting niacin daily for 18 months
12058274|NCT00127218|Drug|Placebo|matching placebo pill daily for 18 months
12058275|NCT00127205|Drug|clodronate disodium|Given orally
12058276|NCT00127205|Drug|ibandronate sodium|Given orally
12058277|NCT00127205|Drug|zoledronic acid|Given IV
12058278|NCT00127192|Drug|sitagliptin phosphate|sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
12058279|NCT00127192|Drug|Comparator: placebo (unspecified)|placebo QD 12-weeks
12058280|NCT00127179|Drug|MK0906, finasteride / Duration of Treatment: 48 weeks|
12058281|NCT00127179|Drug|Comparator: placebo / Duration of Treatment: 48 weeks|
12058282|NCT00127166|Drug|Montelukast sodium|Montelukast 5 mg chewable tablet once daily
12058283|NCT00127166|Drug|Salmeterol xinafoate|Salmeterol 50 mcg dry powder per actuation inhaled twice daily
12058284|NCT00127166|Drug|Fluticasone propionate|Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
12058285|NCT00127166|Drug|Montelukast matching placebo|Matching placebo to montelukast oral tablet administered once daily.
12058286|NCT00127166|Drug|Salmeterol matching placebo|Matching placebo to salmeterol dry powder for inhalation administered twice daily
12058287|NCT00127153|Biological|V110, pneumococcal vaccine polyvalent|
12058288|NCT00127140|Drug|vorinostat|
12058289|NCT00127127|Drug|vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)|vorinostat; level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day
12058290|NCT00127114|Drug|Amantadine|
12058291|NCT00127114|Drug|Placebo|
12058292|NCT00127101|Drug|vorinostat|Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
12058293|NCT00127101|Drug|Comparator: bexarotene|Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
12058294|NCT00127088|Drug|docetaxel|
12058295|NCT00127088|Procedure|laparoscopic radical prostatectomy|
12058296|NCT00127075|Drug|nomegestrol acetate|10 mg/day
12058297|NCT00127075|Drug|estradiol|75 mcg, once a week
12058298|NCT00127075|Drug|placebo|matching placebo treatments
12058299|NCT00127062|Other|Oxford street|2 h walk around Oxford street
12058300|NCT00127062|Other|Hyde park|2 h walk around Hyde park
12058301|NCT00127049|Drug|gemcitabine, ifosfamide, cisplatin, G-CSF|
12058302|NCT00127036|Drug|XELOX|XELOX: Oxaliplatin 130 mg/m^2 intravenously (IV); Capecitabine 825 mg/m^2 by mouth (po)
12058303|NCT00127036|Drug|XELIRI|XELIRI: Irinotecan 240 mg/m^2 IV; Capecitabine 825 mg/m^2 by mouth (po)
12058304|NCT00127036|Drug|Bevacizumab|7.5 mg/kg intravenously (IV)
12058305|NCT00127023|Biological|Measles, Mumps, Rubella and Chickenpox (live vaccine)|
12058306|NCT00127010|Biological|Measles, Mumps, Rubella and Chickenpox (live vaccine)|
12058307|NCT00126997|Biological|Measles, Mumps, Rubella and Chickenpox (live vaccine)|
12058308|NCT00126984|Biological|Conjugated meningococcal ACWY-TT (vaccine)|One intramuscular dose during the primary vaccination
12058309|NCT00126984|Biological|DTPa/Hib containing vaccine|One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
12058310|NCT00126984|Biological|Meningitec|One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
12058311|NCT00126984|Biological|Mencevax ACWY|One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)
12058312|NCT00126971|Drug|chlorproguanil-dapsone|
12058313|NCT00126958|Procedure|urinary analysis|
12058314|NCT00126945|Biological|Meningococcal Vaccine|
12058315|NCT00126932|Device|SonoPrep|
12058316|NCT00126919|Device|SonoPrep|
12058317|NCT00126906|Drug|Monthly sulfadoxine/pyrimethamine|
12058318|NCT00126906|Drug|2-dose sulfadoxine/pyrimethamine|
12058319|NCT00126893|Drug|CC-401|
12058320|NCT00126880|Drug|AVX754|apricitabine, 600mg BID or 800mg BID
12058321|NCT00126880|Drug|3TC|3TC, 150mg BID
12058322|NCT00126854|Procedure|Magnetic Resonance Spectroscopy Imaging|
12058323|NCT00126841|Procedure|CT and MR fusion|
12058324|NCT00126828|Procedure|External beam radiotherapy|
12058325|NCT00126802|Procedure|Tomotherapy|Standard 45 Gy in 25 fractions in 5 weeks
12058326|NCT00126789|Drug|Fentanyl Transdermal Matrix Patch ZR-02-01|ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and will be available in 25, 50, 75 and 100 mcg/hr patches. The patches will be worn on the chest or upper arm and an overlay will be placed over the patch. Patches (and overlays) will be replaced every 3 days by the patient and/or responsible caregiver. If a patient experiences end-of-dose-failure, the dosing interval may be changed by the physician investigator to every 2 days. The maximum dose allowed in this study is 300 mcg/hr.
12058327|NCT00126776|Behavioral|case management|case/self management for COPD vs usual care
12058328|NCT00126776|Behavioral|usual care|usual care for COPD
12058329|NCT00126763|Drug|Fentanyl Transdermal Matrix Patch ZR-02-01|ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and was available in 25, 50,75 and 100 mcg/hr patches. For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose. For patients who were taking oral opioids, the initial dose of ZR-02-01 was determined by the investigator using sponsor-provided conversion guidelines. The patches were worn on the chest or upper arm and an overlay was placed over the patch. Patches (and overlays) were replaced every 3 days
12058330|NCT00126750|Behavioral|VA MI Plus Interactive|The experimental intervention, customized to the individual clinician in real-time consists of Internet learning modules integrating case-based education with audit, feedback, and benchmarking of practice profiles.
12058331|NCT00126737|Other|Weight Control Nutritional Program|a week of food diary and information about dietary fat intake and proper proportions of vegetables.
12058332|NCT00126737|Other|Home-based exercise program|24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
12058333|NCT00126724|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^11 DRP/mL
12058334|NCT00126724|Genetic|tgAAC94 gene therapy vector|Second dose of 1x10^11 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
12058335|NCT00126724|Genetic|tgAAC94 placebo|placebo
12058336|NCT00126724|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^12 DRP/mL tgAAC94
12058337|NCT00126724|Genetic|tgAAC94 gene therapy vector|Second dose of 1x10^12 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
12058338|NCT00126724|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^13 DRP/mL tgAAC94
12058339|NCT00126724|Genetic|tgAAC94 gene therapy vector|Second dose of 1x10^13 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
12058340|NCT00126698|Drug|trimethoprim-sulfamethoxazole|
12058341|NCT00126698|Drug|ciprofloxacin|
12058342|NCT00126685|Biological|autologous tumor cell vaccine|
12058343|NCT00126685|Biological|therapeutic autologous dendritic cells|
12058344|NCT00126672|Drug|sirolimus|
12058345|NCT00126659|Procedure|therapeutic conventional surgery|Undergo cytoreductive nephrectomy
12058346|NCT00126659|Drug|sorafenib tosylate|Given orally
12058347|NCT00126659|Other|laboratory biomarker analysis|Correlative studies
12058348|NCT00126646|Drug|BL22 immunotoxin|
12058349|NCT00126646|Procedure|antibody-drug conjugate therapy|
12058350|NCT00126646|Procedure|immunotoxin therapy|
12058351|NCT00126633|Biological|bevacizumab|
12058352|NCT00126633|Drug|cisplatin|
12058353|NCT00126633|Drug|gemcitabine hydrochloride|
12058354|NCT00126620|Drug|erlotinib hydrochloride|
12058355|NCT00126620|Drug|sorafenib tosylate|
12058356|NCT00126607|Biological|trastuzumab|Given IV
12058357|NCT00126607|Other|laboratory biomarker analysis|Correlative studies
12058358|NCT00126594|Drug|Sorafenib Tosylate|Given orally 400 mg orally (PO) every 12 hours
12058359|NCT00126594|Biological|Recombinant Interferon Alfa-2b|Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10^6 international units twice daily
12058360|NCT00126594|Other|Laboratory Biomarker Analysis|Correlative studies
12058361|NCT00126581|Drug|Carboplatin|Given IV
12058362|NCT00126581|Drug|Erlotinib|Given PO
12058363|NCT00126581|Drug|Erlotinib Hydrochloride|Given PO
12058364|NCT00126581|Drug|Paclitaxel|Given IV
12058365|NCT00126568|Drug|sorafenib tosylate|Given orally
12058366|NCT00126555|Drug|Gefitinib|Oral Gefitinib induction therapy given daily for 2 months at 250 mg/day, once a day for 30 days (1 cycle = 30 days) with at least 2 cycles of treatment (60 days) given. After 2 months evaluate for clinical response (15 days) and resectability (60 days). If after 15 days with no tumor response, daily dose doubled (500 mg), and discontinuation if tumor progression.
12058367|NCT00126555|Radiation|Radiotherapy|Undergo radiation therapy treatments once a day Monday through Friday for about 7 weeks. Each treatment takes about 15 minutes.
12058368|NCT00126555|Procedure|Conventional surgery|Undergo surgery
12058369|NCT00126555|Other|laboratory biomarker analysis|Correlative studies
12058370|NCT00126542|Biological|bevacizumab|Given IV
12058371|NCT00126542|Drug|erlotinib hydrochloride|Given orally
12058372|NCT00126542|Other|laboratory biomarker analysis|Correlative studies
12058373|NCT00126516|Drug|Angiotensin II Receptor Antagonists|any dosage, frequency, and duration
12058374|NCT00126516|Drug|Angiotensin-converting Enzyme Inhibitors|any dosage, frequency, and duration
12058375|NCT00126503|Biological|Bevacizumab|Given IV
12058376|NCT00126503|Drug|Sorafenib Tosylate|Given PO
12058377|NCT00126503|Other|Pharmacological Study|Correlative studies
12058378|NCT00126503|Other|Laboratory Biomarker Analysis|Correlative studies
12058379|NCT00126490|Biological|Aldesleukin|Given subcutaneously
12058380|NCT00126490|Biological|Bevacizumab|Given IV
12058381|NCT00126490|Other|Laboratory Biomarker Analysis|Correlative studies
12058382|NCT00126477|Procedure|cognitive assessment|
12058383|NCT00126477|Procedure|management of therapy complications|
12058384|NCT00126477|Procedure|psychosocial assessment and care|
12058385|NCT00126477|Procedure|quality-of-life assessment|
12058386|NCT00126464|Drug|fulvestrant|
12058387|NCT00126464|Drug|tamoxifen citrate|
12058388|NCT00126464|Procedure|conventional surgery|
12058389|NCT00126464|Procedure|neoadjuvant therapy|
12058390|NCT00126451|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)|
12058391|NCT00126451|Drug|Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles|
12058392|NCT00126438|Drug|123I-mIBG (meta-iodobenzylguanidine)|Single Dose
12058393|NCT00126425|Drug|123I-mIBG (meta-iodobenzylguanidine)|Single dose
12058394|NCT00126412|Drug|123I-mIBG (meta-iodobenzylguanidine)|
12058395|NCT00126399|Drug|doxycycline|
12058396|NCT00126386|Drug|Zoledronic acid (Zometa)|
12058397|NCT00126373|Drug|Wellbutrin (bupropion)|bupropion 150mg-300mg daily
12058398|NCT00126360|Drug|Timing of Anastrozole in respect to radiotherapy|
12058399|NCT00126347|Procedure|supplementation with betaine, serine, and folic acid|
12058400|NCT00126334|Procedure|Packed Red Blood Cell Transfusion|transfusion of 1 unit of PRBCs
12058401|NCT00126321|Drug|cladribine|2-chlorodeoxyadenosine, 2-CdA
12058402|NCT00126308|Device|poly-L-lactic acid|immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)
12058403|NCT00126308|Device|poly-L-lactic acid|delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)
12058404|NCT00126295|Device|'What you need to know about stroke' education package|
12058405|NCT00126282|Behavioral|behavior therapy|
12058406|NCT00126282|Drug|D-Cycloserine|
12058407|NCT00126269|Drug|cisplatin|
12058408|NCT00126269|Drug|gemcitabine|
12058409|NCT00126256|Drug|5-fluorouracil|
12058410|NCT00126256|Drug|leucovorin|
12058411|NCT00126256|Drug|irinotecan|
12058412|NCT00126256|Drug|oxaliplatin|
12058413|NCT00126243|Drug|rituximab|
12058414|NCT00126243|Drug|CHOP|
12058415|NCT00126230|Drug|docetaxel and samarium|
12058416|NCT00126217|Biological|Bacille Calmette Guerin (BCG)|0,1 ml, revaccination at 19 months of age
12058417|NCT00126204|Drug|Doxycycline|
12058418|NCT00126191|Drug|Rituximab|Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1
12058419|NCT00126191|Drug|Cyclophosphamide|Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)
12058420|NCT00126191|Drug|Doxorubicin|Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)
12058421|NCT00126191|Drug|Vincristine|Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)
12058422|NCT00126191|Drug|Methotrexate|Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle
12058423|NCT00126191|Drug|Leucovorin|Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)
12058424|NCT00126191|Drug|Ifosfamide|High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle
12058425|NCT00126191|Drug|Etoposide|High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle
12058426|NCT00126191|Drug|Cytarabine|Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle
12058427|NCT00126191|Drug|Mesna|High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle
12058428|NCT00126178|Biological|HSPPC-96|
12058429|NCT00126165|Procedure|radiotherapy|
12058430|NCT00126152|Behavioral|Exercise, education and medical management|
12058431|NCT00126139|Drug|Abciximab|
12058432|NCT00126126|Other|EBAR Program|Evidence Based Amputee Rehabilitation Program
12058433|NCT00126113|Behavioral|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
12058434|NCT00126113|Behavioral|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
12058435|NCT00126100|Drug|G-CSF Granulocyte-Colony Stimulating Factor|Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.
12058436|NCT00126100|Other|Placebo|Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.
12058437|NCT00126087|Drug|dopamine|
12058438|NCT00126074|Drug|Tedisamil sesquifumarate|
12058439|NCT00126061|Drug|Tedisamil sesquifumarate|
12058440|NCT00126048|Drug|Atorvastatin|40mg tablet
12058441|NCT00126048|Drug|Placebo|Placebo tablet
12058442|NCT00126035|Device|Migraid|
12058443|NCT00126022|Drug|Tedisamil sesquifumarate|
12058444|NCT00126009|Drug|Amisulpride|
12058445|NCT00125996|Drug|Venofer (intravenous iron sucrose)|
12058446|NCT00125983|Drug|Lopinavir/ritonavir|
12058447|NCT00125983|Drug|Ortho Novum 1/35|
12058448|NCT00125983|Drug|Ortho Evra|
12058449|NCT00125970|Biological|VRC-HIVDNA016-00-VP|4 mg administered in deltoid
12058450|NCT00125970|Biological|VRC-HIVADV014-00-VP|1 x 10^10 PU administered in deltoid
12058451|NCT00125970|Biological|VRC-HIVDNA016-00-VP placebo|1 mL administered at study entry and Months 1 and 2
12058452|NCT00125970|Biological|VRC-HIVADV014-00-VP placebo|1 mL administered at Month 6
12058453|NCT00125957|Drug|Wellbutrin|
12058454|NCT00125957|Drug|Placebo|
12058455|NCT00125944|Biological|FluMist|
12058456|NCT00125931|Drug|Talwin Nx|Talwin NX 50mg po twice
12058457|NCT00125918|Drug|tadalafil|tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
12058458|NCT00125918|Drug|tadalafil|tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
12058459|NCT00125918|Drug|tadalafil|tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
12058460|NCT00125918|Drug|tadalafil|tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
12058461|NCT00125918|Drug|placebo|placebo tablet taken by mouth once a day for 16 weeks
12058462|NCT00125905|Behavioral|Advice|
12058463|NCT00125905|Behavioral|Motivational Interviewing|
12058464|NCT00125905|Drug|Nicotine Gum and Patch|
12058465|NCT00125905|Drug|Bupropion|
12058466|NCT00125892|Drug|duloxetine|
12058467|NCT00125879|Biological|Myozyme|20 mg/kg qow or 40 mg/kg qow
12058468|NCT00125866|Behavioral|Flavonoid rich or flavonoid depleted chocolate drink|
12058469|NCT00125853|Drug|Nebivolol|Nebivolol 2.5mg daily
12058470|NCT00125853|Drug|Atenolol|Atenolol 25mg daily
12058471|NCT00125840|Drug|clofarabine (IV formulation)|
12058472|NCT00125827|Drug|clofarabine (oral formulation)|Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response. The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined.
12058473|NCT00125814|Drug|Interferon alfa-2b|
12058474|NCT00125814|Procedure|Structured treatment interruptions|
12058475|NCT00125801|Drug|Subcutaneous hydromorphone delivered by pain pen|Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.
12058476|NCT00125788|Drug|L-glutamine|Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams.
12058477|NCT00125788|Drug|Placebo|Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams.
12058478|NCT00125775|Biological|Engerix-B|Engerix-B at 0, 1, 6 months
12058479|NCT00125762|Device|FibroScan|
12058480|NCT00125749|Biological|Dendritic cell vaccination|Autologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells
12058481|NCT00125736|Drug|E0671|One 50 mg capsule is orally administered three times daily (150 mg/day)
12058482|NCT00125736|Drug|rabeprazole sodium|One 10mg tablet is administered orally each day
12058483|NCT00125736|Drug|E0671 placebo|One 50 mg capsule is orally administered three times daily (150 mg/day)
12058484|NCT00125723|Other|PI Discretion|PI Discretion
12058485|NCT00125697|Procedure|3T MRI Scanning|pre-radiation therapy, week 4 radiation therapy, 2 months post radiation therapy and every 4 months for the first year
12058486|NCT00125684|Drug|morphine|
12058487|NCT00125671|Drug|Warfarin|
12058488|NCT00125658|Other|Control|Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic resistance exercise). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
12058592|NCT00124761|Procedure|Surgery + WBRT|Surgery - complete excision of Solitary Brain Metastasis with 30 Gy in 10 fractions over 2 2 1/2 weeks
12058489|NCT00125658|Other|Experimental|Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
12058490|NCT00125645|Drug|Irbesartan Oral Tablet|
12058491|NCT00125632|Procedure|Eccentric Viewing Training for Reading|
12058492|NCT00125619|Behavioral|Locomotor training|This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.
12058493|NCT00125606|Procedure|conditioning for allogeneic HSCT|
12058494|NCT00125593|Drug|Simvastatin 20 mg|Once daily
12058495|NCT00125593|Drug|Ezetimibe 10mg|Once daily
12058496|NCT00125593|Drug|Placebo|Once daily
12058497|NCT00125580|Behavioral|Infant sleep instruction|
12058498|NCT00125567|Drug|Stalevo (levodopa/carbidopa/entacapone)|Oral, 50-150 mg levodopa four times daily, for up to 2 years
12058499|NCT00125567|Drug|Levodopa/carbidopa|Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
12058500|NCT00125554|Drug|Metyrapone|
12058501|NCT00125541|Drug|C1 inhibitor concentrate (C1-esteraseremmer-N)|every 5-7 days
12058502|NCT00125528|Drug|D-cycloserine|D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
12058503|NCT00125528|Drug|placebo|placebo bid
12058504|NCT00125515|Drug|Memantine|One arm receives 30 mg bid and the other arm receives receives 15mg bid
12058505|NCT00125515|Drug|Naltrexone|Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
12058506|NCT00125502|Biological|CMV gB vaccine|CMV gB is combined with a novel adjuvant, MF59, a proprietary oil-in-water emulsion, administered at 0, 1, and 6 months.
12058507|NCT00125502|Drug|MF59 adjuvant|Oil-in-water emulsion
12058508|NCT00125502|Drug|Placebo|Normal saline solution
12058509|NCT00125489|Drug|chloroquine sulfate|
12058510|NCT00125489|Drug|sulfadoxine/pyrimethamine|
12058511|NCT00125476|Behavioral|Exercise|
12058512|NCT00125463|Drug|Candesartan cilexetil|
12058513|NCT00125450|Procedure|Chest Physiotherapy with Forced Expiratory Technique|Chest Physiotherapy with Forced Expiratory Technique
12058514|NCT00125450|Procedure|Nasopharyngeal Aspiration|Nasopharyngeal Aspiration
12058515|NCT00125437|Drug|spironolactone|
12058516|NCT00125424|Drug|AQUAVAN® (fospropofol disodium) Injection|
12058517|NCT00125424|Drug|Midazolam HCl|
12058518|NCT00125411|Drug|satraplatin and docetaxel|"Satraplatin - oral administration within 2 hours of docetaxel infusion. Subsequent dosing will be on days 2-5 at approximate 24 hour intervals.
~Docetaxel will be administered as intravenous infusion over 1 hour followed by saline flush."
12058519|NCT00125398|Drug|AQUAVAN (fospropofol disodium; GPI 15715 )|
12058520|NCT00125385|Biological|GC1008|0.3 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
12058521|NCT00125385|Biological|GC1008|1.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
12058522|NCT00125385|Biological|GC1008|2.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
12058523|NCT00125385|Biological|GC1008|4.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
12058524|NCT00125385|Biological|GC1008|8.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
12058525|NCT00125372|Drug|erlotinib (Tarceva) and bexarotene (Targretin)|Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
12058526|NCT00125359|Drug|erlotinib and bexarotene|Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
12058527|NCT00125346|Drug|Tobramycin Inhalation Powder|
12058528|NCT00125333|Drug|NF-kappaB Decoy|
12058529|NCT00125320|Drug|RSD1235|
12058530|NCT00125307|Drug|tacrolimus|
12058531|NCT00125294|Drug|Methadone|
12058532|NCT00125281|Drug|S-adenosyl-methionine (SAMe) capsules|
12058533|NCT00125268|Device|MIRE|Monochromatic near infrared photo energy (MIRE). A 30-minute application of MIRE results in a radiant exposure of 43.2 joules per square centimeter (J/cm^2). The design of the flexible pads allows the infrared energy to be delivered perpendicular to and in contact with the involved site. MIRE applied to the skin facilitates the release of a small molecule of the free radical nitric oxide from hemoglobin and other proteins in surrounding tissue. Increased levels of nitric oxide improve the circulation of blood enhancing wound healing and reducing pain.
12058534|NCT00125268|Device|Sham Device|The sham device is non-active but otherwise identical to the study device.
12058535|NCT00125255|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel comprising of a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine was applied topically. The study drug was applied at approximately 1 mm in thickness and remained on the treatment area for 30 minutes
12058536|NCT00125255|Drug|Placebo Peel|Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 30 minutes
12058593|NCT00124761|Radiation|Radiosurgery + WBRT|Radiosurgery - Marginal dose based on maximum tumour diameter
12058594|NCT00124748|Drug|Imatinib mesylate|Imatinib is packaged in bottles as 100mg and 400mg tablets
12058595|NCT00124735|Drug|Rocuronium bolus maintenance|Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
12058596|NCT00124735|Drug|rocuronium continuous infusion maintenance|Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
12058665|NCT00124163|Procedure|Imaging procedure of CT colonography|
12058537|NCT00125242|Behavioral|Semantic Feature Analysis (SFA)Training|SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, action associated with item). For some participants, treatment items were grouped according to typicality of category membership (e.g,, a robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in the context of single-subject, multiple baseline designs. In this way, replication of treatment effects could be evaluated within and across participants. Treatment was administered by certified SLPs three times per week until prescribed accuracy levels were met during nontreatment probes or a maximum number of treatment sessions was completed.
12058538|NCT00125229|Drug|Mannitol|
12058539|NCT00125229|Drug|Hypertonic Saline|
12058540|NCT00125216|Behavioral|Response Elaboration Training|Therapist modeling, reinforcement and forward-chaining are used to stimulate verbal descriptions of pictures
12058541|NCT00125203|Drug|Botulinum toxin type B (Myobloc)|
12058542|NCT00125203|Procedure|Injection of salivary glands|
12058543|NCT00125190|Drug|rhIGF-1 (mecasermin) for a period of 86 weeks|Once a day rhIGF-1 injections
12058544|NCT00125177|Behavioral|Knack therapy|
12058545|NCT00125164|Drug|rhIGF-1 (mecasermin, Tercica, Inc.)|Twice Daily Injection
12058546|NCT00125151|Drug|C1 inhibitor concentrate (C1-esteraseremmer-N)|
12058547|NCT00125138|Drug|Melperone HCl|20 mg/day. Strength of melperone syrup is 5 mg/mL
12058548|NCT00125138|Drug|Melperone HCl|40 mg/day. Strength of melperone syrup is 5 mg/mL
12058549|NCT00125138|Drug|Melperone HCl|60 mg/day. Strength of melperone syrup is 5 mg/mL
12058550|NCT00125138|Drug|Placebo|Syrup formulation
12058551|NCT00125125|Drug|Fluvastatin|
12058552|NCT00125112|Behavioral|Internet-based intervention designed to reduce binge eating and improve healthy weight regulation|
12058553|NCT00125099|Biological|VRC-HIVDNA009-00-VP|
12058554|NCT00125086|Device|autologous platelet gel|
12058555|NCT00125073|Behavioral|Postoperative nutritional counseling|
12058556|NCT00125060|Drug|Simvastatin (20mg versus 80mg/day)|
12058557|NCT00125047|Biological|Typhoid Vi vaccine|Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
12058558|NCT00125047|Biological|Hepatitis A vaccine|single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
12058559|NCT00125034|Biological|Cetuximab|"Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).
~Until progression or unacceptable toxicity develops"
12058560|NCT00125034|Drug|Oxaliplatin|"Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).
~Until progression or unacceptable toxicity develops"
12058561|NCT00125021|Drug|Capecitabine|Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
12058562|NCT00125021|Drug|OSI-774|Given once daily
12058563|NCT00125008|Biological|Typhoid Vi vaccine|single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)
12058564|NCT00125008|Biological|Hepatitis A vaccine|720 EL.U. of inactivated hepatitis A viral antigen for children 1440 EL.U. of inactivated hepatitis A viral antigen for adults
12058565|NCT00124995|Drug|terbutaline|
12058566|NCT00124982|Drug|Abatacept|IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
12058567|NCT00124982|Drug|Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)|During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).
12058568|NCT00124982|Drug|Anti-Tumor Necrosing Factor (TNF) Therapy|Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months
12058569|NCT00124969|Drug|Amlodipine|10mg
12058570|NCT00124969|Drug|Placebo|10mg
12058571|NCT00124956|Drug|Doxorubicin|
12058572|NCT00124943|Drug|Nanoparticle Paclitaxel|Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
12058573|NCT00124930|Drug|Olanzapine|
12058574|NCT00124930|Drug|Haldol|
12058575|NCT00124917|Radiation|Radiation|Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1]
12058576|NCT00124904|Behavioral|Biofeedback|
12058577|NCT00124904|Behavioral|Kegel exercises|
12058578|NCT00124891|Drug|Double-blind investigational anti-arrhythmic|
12058579|NCT00124891|Drug|GAP-486|
12058580|NCT00124878|Procedure|Male circumcision|Sleeve circumcision
12058581|NCT00124865|Biological|rFla-MBP|
12058582|NCT00124852|Behavioral|n-3 Fatty Acid Supplementation|
12058583|NCT00124839|Drug|Naltrexone|Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone
12058584|NCT00124826|Drug|Insulin|
12058585|NCT00124813|Drug|thalidomide|
12058586|NCT00124813|Drug|idarubicin|oral idarubicin
12058587|NCT00124800|Behavioral|Tinnitus retraining therapy|Sound therapy and counseling
12058588|NCT00124800|Device|Sound therapy|sound therapy and counselling
12058589|NCT00124787|Drug|Dimenhydrinate|Dimenhydrinate PO q 6 hours x 4 doses
12058590|NCT00124787|Drug|Placebo|Placebo PO q 6 hours x 4 doses
12058591|NCT00124774|Procedure|Nucleoplasty|
12058597|NCT00124722|Drug|Rocuronium bromide (Zemuron)|A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
12058598|NCT00124722|Drug|Rocuronium bromide (Zemuron)|A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
12058599|NCT00124722|Drug|Rocuronium bromide (Zemuron)|A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
12058600|NCT00124709|Drug|Pimecrolimus|Pimecrolimus cream 1 %
12058601|NCT00124709|Drug|Corticosteroid|conventional corticosteroid-based treatment
12058602|NCT00124696|Drug|Cocaethylene|
12058603|NCT00124683|Drug|Bupropion|
12058604|NCT00124683|Drug|nicotine transdermal patch|
12058605|NCT00124657|Drug|Erlotinib hydrochloride|This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).
12058606|NCT00124644|Drug|cytarabine|
12058607|NCT00124644|Drug|daunorubicin hydrochloride|
12058608|NCT00124644|Drug|etoposide|
12058609|NCT00124644|Drug|tipifarnib|
12058610|NCT00124644|Procedure|chemotherapy|
12058611|NCT00124644|Procedure|enzyme inhibitor therapy|
12058612|NCT00124644|Procedure|high-dose chemotherapy|
12058613|NCT00124618|Biological|cetuximab|
12058614|NCT00124618|Radiation|radiation therapy|
12058615|NCT00124605|Drug|pamidronate disodium|Given IV
12058616|NCT00124605|Drug|arsenic trioxide|Given IV
12058617|NCT00124605|Other|laboratory biomarker analysis|Correlative studies
12058618|NCT00124605|Other|pharmacological study|Correlative studies
12058619|NCT00124579|Drug|bortezomib|induction: 1 mg/m2 IV push days 1, 4, 8, 11 every 21 days
12058620|NCT00124579|Drug|dexamethasone|induction: 20 mg/d PO days 1, 2, 4, 5, 8, 9, 11, 12 every 21 days maintenance: 40 mg days 1-4 every 28 days until progression
12058621|NCT00124579|Drug|thalidomide|100 mg/d PO days 1-21 every 21 days
12058622|NCT00124566|Drug|Irofulven|Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.45 mg/kg on Days 1 and 8 every 3 weeks.
12058623|NCT00124566|Drug|Prednisone|Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
12058624|NCT00124566|Drug|Mitoxantrone|Subjects will receive mitoxantrone in an intravenous (IV) infusion (5 to 15 minutes) at a dose of 12 mg/m^2 per day, once every 3 weeks.
12058625|NCT00124566|Drug|Capecitabine|Subjects will receive oral capecitabine at a dose of 1000 mg/m^2 twice daily for 15 days every 28 days.
12058626|NCT00124566|Drug|Irofulven|Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.
12058627|NCT00124553|Behavioral|Intensive dietary advice|
12058628|NCT00124540|Drug|misoprostol|
12058629|NCT00124540|Drug|placebo|placebo resembling misoprosotl
12058630|NCT00124527|Drug|Irofulven + capecitabine|
12058631|NCT00124514|Drug|Triptorelin pamoate|IM injection given monthly
12058632|NCT00124501|Behavioral|Biofeedback-assisted relaxation training|10 sessions BART
12058633|NCT00124488|Device|Tomotherapy Treatment Planning|
12058634|NCT00124475|Drug|alitretinoin|
12058635|NCT00124462|Device|Realigning knee brace and custom orthodic|A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
12058636|NCT00124462|Device|Non realigning knee brace and flat orthodic|A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
12058637|NCT00124449|Drug|Abatacept|"solution, intravenous injection, monthly, 169 days
~weight based:
~<60 kg = 500 mg
~60 to 100 kg = 750 mg
~>100 kg = 1 g"
12058638|NCT00124449|Drug|placebo|solution, intravenous injection, 0 mg, monthly, 169 days
12058639|NCT00124436|Drug|alitretinoin|
12058640|NCT00124423|Procedure|Megavoltage CT scan|
12058641|NCT00124397|Drug|Atorvastatin|
12058642|NCT00124384|Behavioral|CBT-I|
12058643|NCT00124384|Drug|modafinil|
12058644|NCT00124371|Behavioral|a nurse led home-based education and support programme|
12058645|NCT00124358|Drug|Buprenorphine|
12058646|NCT00124358|Behavioral|Integrated HIV care and office-based opioid dependence treatment|
12058647|NCT00124345|Device|MR730|humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort
12058648|NCT00124332|Drug|Rimonabant (SR141716)|
12058649|NCT00124332|Drug|Placebo|
12058650|NCT00124306|Drug|Amitriptyline|Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet.
12058651|NCT00124306|Other|Placebo|Placebo will be dosed exactly as active arm.
12058652|NCT00124293|Drug|activated recombinant human factor VII|
12058653|NCT00124280|Drug|RAD001|
12058654|NCT00124267|Drug|Intrarectal quinine|
12058655|NCT00124254|Procedure|Silicone metacarpophalangeal joint arthroplasty|Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
12058656|NCT00124254|Other|Usual care|Non-surgical usual care
12058657|NCT00124241|Drug|telbivudine|
12058658|NCT00124241|Drug|lamivudine|
12058659|NCT00124228|Drug|Human Albumin|albumin 1.5g/kg body weight the first day of inclusion plus 1g/kg/body weight the 3th day of inclusion.
12058660|NCT00124215|Biological|GI-5005|Heat-killed yeast cell transfected with NS3-Core fusion protien.
12058661|NCT00124202|Behavioral|a fatty meal|Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group
12058662|NCT00124189|Drug|GRN163L|Weekly intravenous infusion
12058663|NCT00124176|Drug|Racemic albuterol (R+S albuterol)|20mg/hr continuous racemic albuterol
12058664|NCT00124176|Drug|Levalbuterol (R albuterol)|10mg/hr continuous nebulized levalbuterol
12058968|NCT00121888|Drug|Paroxetine-CR|
12058666|NCT00124150|Drug|Intravenous magnesium sulfate infusion|80mg per day
12058667|NCT00124137|Device|Aquadex system|
12058668|NCT00124137|Drug|IV diuretic|
12058669|NCT00124124|Drug|KLH; Peptides; Dendritic Cells|Upon entry into the study, patients randomized to the dendritic cell arm will undergo a complete baseline evaluation and leukapheresis 0.5 to 3 x 106 DCs per peptide antigen (total not to exceed 18 x 106 cells) will be administered intradermally as per injection SOP. They will receive up to 3 booster DC injections (total not to exceed 18 x 10 6 cells per injection) at monthly intervals for a total of 4 injections. The booster injections will not contain KLH, as our volunteer studies have shown that priming occurs following a single injection of DCs
12058670|NCT00124124|Drug|KLH, peptides plus Montanide|Patients randomized to the Montanide arm will also undergo complete baseline evaluation but not leukapheresis. The peptides will be mixed with the adjuvant, Montanide, and administered subcutaneously at a dose of 100 microgram of each peptide +100 microgram KLH mixed with an equal volume of Montanide. They will receive up to 3 booster injections at monthly intervals for a total of 4 injections. The booster injections will not contain KLH.
12058671|NCT00124111|Drug|pegfilgrastim|
12058672|NCT00124111|Drug|cyclophosphamide|
12058673|NCT00124111|Drug|methotrexate|
12058674|NCT00124111|Drug|5-fluorouracil|
12058675|NCT00124098|Drug|Aranesp® (darbepoetin alfa)|
12058676|NCT00124085|Behavioral|Disease Management|
12058677|NCT00124085|Behavioral|Disease Management + Educational Home Visits|
12058678|NCT00124072|Drug|Simvastatin 20 mg daily|Simvastatin 20 mg tablet once daily
12058679|NCT00124072|Dietary Supplement|Folic acid 2 mg + vitamin B12 1 mg daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily
12058680|NCT00124072|Drug|Simvastatin 80 mg daily|Simvastatin 80 mg tablet once daily
12058681|NCT00124072|Drug|Placebo|Placebo vitamin B12/folic acid tablet once daily
12058682|NCT00124059|Drug|Seroquel|400mg/day quetiapine
12058683|NCT00124059|Drug|Placebo|400mg/day placebo
12058684|NCT00124046|Procedure|Surgery|Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two
12058685|NCT00124046|Procedure|Medical Treatment|Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two
12058686|NCT00124033|Procedure|Transcystic Stenting (Facilitated ERCP)|
12058687|NCT00124020|Drug|Telavancin|Telavancin 10 mg/kg/day IV for up to 21 days
12058688|NCT00124020|Drug|Vancomycin|Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days
12058689|NCT00124007|Biological|VRC-HIVADV014-00-VP|
12058690|NCT00124007|Biological|VRC-HIVDNA016-00-VP|
12058691|NCT00123994|Behavioral|Tai Chi classes|
12058692|NCT00123994|Behavioral|Hydrotherapy classes|
12058693|NCT00123981|Procedure|Off-Pump Coronary Artery Bypass Grafting|
12058694|NCT00123968|Biological|VRC-HIVDNA016-00-VP|1x10^11 per unit vaccine administered intramuscularly via Bioinjector
12058695|NCT00123968|Biological|VRC-HIVADV014-00-VP|4 mg administered intramuscularly via injection
12058696|NCT00123968|Biological|VRC-DILUENT013-DIL-VP|Administered intramuscularly via Bioinjector
12058697|NCT00123968|Biological|VRC-HIVADV014-00-VP placebo|4 mg administered intramuscularly via injection
12058698|NCT00123955|Drug|Spironolactone|25mg tablet daily for 9 months
12058699|NCT00123955|Drug|Placebo|Placebo tablet daily for 9 months
12058700|NCT00123942|Drug|MEDI-507|
12058701|NCT00123929|Drug|docetaxel|100 mg/m2 every 3 weeks times 4
12058702|NCT00123929|Drug|doxorubicin|75 mg/m2 every 3 weeks times 4
12058703|NCT00123916|Drug|Benznidazole|Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)
12058704|NCT00123916|Drug|Placebo|a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 - 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg)
12058705|NCT00123903|Drug|metoprolol xl|
12058706|NCT00123903|Drug|carvedilol MR|
12058707|NCT00123903|Drug|lisinopril|
12058708|NCT00123890|Drug|GW873140|
12058709|NCT00123877|Drug|GPX-100 (13-deoxydoxorubicin)|
12058710|NCT00123864|Procedure|Intensity-modulated radiation therapy|
12058711|NCT00123851|Drug|Tarceva (OSI-774)|
12058712|NCT00123851|Drug|Capecitabine|
12058713|NCT00123851|Drug|Oxaliplatin|
12058714|NCT00123838|Device|Calypso® 4D Localization System|Localization of prostate irradiation.
12058715|NCT00123825|Drug|Gemcitabine|
12058716|NCT00123825|Drug|Cisplatin|
12058717|NCT00123799|Procedure|Positron Emission Tomography Imaging|
12058718|NCT00123786|Procedure|Positron Emission Tomography|Positron Emission Tomography
12058719|NCT00123773|Procedure|Positron Emission Tomography|
12058720|NCT00123760|Procedure|Positron Emission Tomography (PET) scan|
12058721|NCT00123747|Procedure|Positron Emission Tomography (PET) scan Imaging|
12058722|NCT00123734|Drug|ThromboView|
12058723|NCT00123682|Procedure|Proactive outreach to counseling|Project staff reach out to engage referred smoker into telephone counseling
12058724|NCT00123682|Procedure|Reactive outreach to counseling|Project staff send a letter to referred smoker, asking them to call to engage in telephone counseling
12058725|NCT00123682|Procedure|Intensive counseling|Multi-session telephone counseling, delivered by California Smokers' Helpline
12058726|NCT00123682|Procedure|Self-help|Project staff send out self-help materials for smoking cessation
12058727|NCT00123669|Drug|500 mg of depot hydroxy-progesterone|An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.
12058728|NCT00123656|Drug|esomeprazole|esomeprazole dosed qam for 8 weeks
12058729|NCT00123656|Drug|fluticasone|fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
12058730|NCT00123643|Drug|rosiglitazone|
12058731|NCT00123643|Drug|glyburide|
12058732|NCT00123630|Drug|omalizumab|omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
12058733|NCT00123630|Drug|Placebo|Placebo given IV once every 2-4 weeks based on weight
12058734|NCT00123617|Procedure|Phase III group-based cardiac rehabilitation|Phase III group-based cardiac rehabilitation
12058735|NCT00123604|Drug|Carvedilol|25 mg twice daily for five months.
12058736|NCT00123604|Drug|Metoprolol|200 mg twice daily for five months.
12058737|NCT00123591|Drug|activated recombinant human factor VII|
12058738|NCT00123578|Drug|Lorazepam|Lorazepam
12058739|NCT00123578|Drug|Pentobarbital|Pentobarbital
12058740|NCT00123565|Drug|Hexadecasaccharide (SR123781A)|
12058741|NCT00123552|Drug|Amodiaquine+Artesunate|Amodiaquine 10 mg/kg on day 1, then 5 mg/kg on day 2 and 3; Artesunate 4 mg/kg/d for three days
12058742|NCT00123552|Drug|Amodiaquine+Sulfadoxine/Pyrimethamine|Amodiaquine 10 mg/kg on day 1, then 5 mg/kg on day 2 and 3; S/P at 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine single dose
12058743|NCT00123552|Drug|Artemether+Lumefantrine|Artemether 20 mg + Lumefantrine 120 mg 6 dose regimen at 0 and 8 hours on day 1 and twice daily on days 2 and 3:5 kg to < 15 kg: 1 tab/dose; 15 to 24 kg: 2 tabs/dose; >35 kg:4 tabs per dose
12058744|NCT00123539|Drug|Estrogen Replacement Therapy|
12058745|NCT00123539|Procedure|Surgery|
12058746|NCT00123526|Behavioral|Diet|Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.
12058747|NCT00123526|Behavioral|Physical Activity|The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.
12058748|NCT00123513|Behavioral|Diet|Environmental changes in the food and physical activity environment. Cafeteria and vending machine changes, food brought from home, walking routes, and awareness building.
12058749|NCT00123513|Behavioral|Exercise|Increase routing physical activity, walking routes, stairs intervention, etc.
12058750|NCT00123513|Behavioral|Environment|Cafeteria and vending machine changes and identification of opportunities of physical activity.
12058751|NCT00123500|Behavioral|Diet|Diet
12058752|NCT00123500|Behavioral|Physical Activity|Physical Activity
12058753|NCT00123500|Behavioral|Environment|Environment
12058754|NCT00123500|Other|Control Group|Control Group
12058755|NCT00123487|Drug|dasatinib|Tablets, Oral, 70 mg BID, indefinitely, survival study
12058756|NCT00123487|Drug|dasatinib|Tablets, Oral, 140 mg QD, indefinitely, survival study
12058757|NCT00123474|Drug|dasatinib|Tablets, Oral, 50 mg BID, indefinitely, survival study
12058758|NCT00123474|Drug|dasatinib|Tablets, Oral, 70 mg BID, indefinitely, survival study
12058759|NCT00123474|Drug|dasatinib|Tablets, Oral, 100 mg QD, indefinitely, survival study
12058760|NCT00123474|Drug|dasatinib|Tablets, Oral, 140 mg QD, indefinitely, survival study
12058761|NCT00123461|Drug|Hectorol (doxercalciferol capsules), 0.5mcg|
12058762|NCT00123435|Behavioral|Nutritional counseling|The nutritional counseling is based on the six-session Medical Nutrition Therapy Protocol for Weight Management published by the American Dietetics Association. The categories include the following: a) Meal planning (food, hydration, fiber, alcohol), b) Food label reading, c) Recipe modification, d) Food preparation, e) Dining out and f) Physical activity.
12058763|NCT00123435|Behavioral|Walking program|As part of the discussion of physical activity, participants in the control group will be encouraged to walk and dietitians will discuss goal setting using timed walks instead of total daily step-counts at each of the control group sessions. As a general guideline, participants will be encouraged to increase their daily walking target by 5-10 minutes (control group with time goals) or to increase their average daily step counts by 10-25% (pedometer group with step count goals) following each of the nutritional counseling sessions.
12058764|NCT00123435|Behavioral|Nutritional counseling|The nutritional counseling is based on the six-session Medical Nutrition Therapy Protocol for Weight Management published by the American Dietetics Association. The categories include the following: a) Meal planning (food, hydration, fiber, alcohol), b) Food label reading, c) Recipe modification, d) Food preparation, e) Dining out and f) Physical activity.
12058765|NCT00123435|Behavioral|Walking program|As part of the discussion of physical activity, participants in the control group will be encouraged to walk and dietitians will discuss goal setting using timed walks instead of total daily step-counts at each of the control group sessions. As a general guideline, participants will be encouraged to increase their daily walking target by 5-10 minutes (control group with time goals) or to increase their average daily step counts by 10-25% (pedometer group with step count goals) following each of the nutritional counseling sessions.
12058766|NCT00123435|Device|Simple pedometer|Device to be worn during waking hours to give an objective measure of steps taken each day.
12058767|NCT00123435|Behavioral|Nutritional counseling|The nutritional counseling is based on the six-session Medical Nutrition Therapy Protocol for Weight Management published by the American Dietetics Association. The categories include the following: a) Meal planning (food, hydration, fiber, alcohol), b) Food label reading, c) Recipe modification, d) Food preparation, e) Dining out and f) Physical activity.
12058768|NCT00123435|Behavioral|Walking program|As part of the discussion of physical activity, participants in the control group will be encouraged to walk and dietitians will discuss goal setting using timed walks instead of total daily step-counts at each of the control group sessions. As a general guideline, participants will be encouraged to increase their daily walking target by 5-10 minutes (control group with time goals) or to increase their average daily step counts by 10-25% (pedometer group with step count goals) following each of the nutritional counseling sessions.
12058769|NCT00123435|Device|Simple pedometer|Device to be worn during waking hours to give an objective measure of steps taken each day.
12058770|NCT00123435|Device|Enhanced pedometer|Simple pedometer with the addition of web-based feedback.
12058771|NCT00123422|Behavioral|Breathing retraining|exercise training with computerized training program
12058772|NCT00123422|Behavioral|Heliox|exercise training with a helium oxygen combination
12058773|NCT00123422|Behavioral|Exercise|exercise training
12058774|NCT00123409|Behavioral|Telephone disease management|Telephone based care management
12058775|NCT00123409|Behavioral|Usual Care|Usual care
12058776|NCT00123396|Behavioral|BioCASES and BioTESTS|
12058777|NCT00123383|Drug|Modafinil|
12058778|NCT00123370|Drug|Modafinil|
12058779|NCT00123344|Device|AT501 pacemaker|
12058780|NCT00123331|Drug|Cyclosporine discontinuation|
12058781|NCT00123331|Drug|Rapamycin medication|
12058782|NCT00123318|Drug|epirubicin|50mg/m2 IV day 1
12058783|NCT00123318|Drug|cisplatin|60mg/m2 IV day 1
12058784|NCT00123318|Drug|5-fluorouracil|5-FU 200mg/m2/d IV 21 day continuous infusion Cont. infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
12058785|NCT00123318|Radiation|Radiotherapy|45Gy 25 Fractions, 5 days/week for 5 weeks
12058786|NCT00123305|Drug|Microplasmin|1mg/kg bolus of microplasmin solution followed by 1,2 or 3mg/kg infusion of mircroplasmin solution.
12058787|NCT00123305|Drug|Microplasmin|1mg/kg bolus of placebo solution followed by 1,2 or 3mg/kg infusion of placebo solution
12058788|NCT00123292|Drug|Microplasmin|An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
12058789|NCT00123292|Drug|Microplasmin|An infusion of 0.45 mg/kg/hr in conjunction with distal protection device will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
12058790|NCT00123292|Drug|Microplasmin|An infusion of 20 or 40 mg (20 mg for the 15 cm treatment length device; 40 mg for the 30 cm treatment length device) over 10 minutes via the Trellis-8 Peripheral Infusion System catheter, in accordance with the Trellis-8 Instructions for Use. For occlusive lesions that are longer than the treatment length of the Trellis-8 device, a repeat infusion of the same dose and duration may be administered.
12058791|NCT00123279|Drug|Microplasmin|25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
12058792|NCT00123266|Drug|Microplasmin|2 mg/kg, IA over 75 mins
12058793|NCT00123253|Drug|TH9507|
12058794|NCT00123240|Behavioral|Low calorie high carbohydrate diet|65% carbohydrate, 15% protein, 20% fat (7% SFA, 8% MFA, 4% PUFA), P/S 0.63, 152 mg cholesterol/1500 kcal
12058795|NCT00123240|Behavioral|Low calorie high fat/protein diet|High Fat/Protein Diet: 10% carbohydrate, 25% protein, 65% fat (26% SFA, 25% MFA, 9% PUFA), P/S 0.33, 458 mg cholesterol/1500 kcal
12058796|NCT00123227|Drug|Rosiglitazone|
12058797|NCT00123214|Drug|Controlled Dietary Intervention|
12058798|NCT00123201|Drug|Dronabinol MDI|
12058799|NCT00123188|Procedure|Ultrasound and Biopsy|Transvaginal ultrasound and Endometrial Biopsy
12058800|NCT00123175|Device|Intrauterine Device|Mirena and Provera
12058801|NCT00123162|Drug|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.
12058802|NCT00123162|Drug|Placebo|A single vaginal dose of placebo and monitored for 4 hours.
12058803|NCT00123149|Drug|Epoetin alfa|
12058804|NCT00123136|Device|foot energizer|
12058805|NCT00123123|Drug|chlorhexidine gluconate oral rinse (0.12%)|chlorhexidine gluconate oral rinse
12058806|NCT00123123|Drug|placebo|
12058807|NCT00123110|Drug|metformin|Initiated on 500 mg daily and titrated up to 1000 mg twice a day during the first four weeks, remaining at that dose until 12 weeks
12058808|NCT00123110|Drug|leuprolide injection|3.75 mg injection every 4 weeks (e.g. at baseline, 4, and 8 weeks)
12058809|NCT00123110|Drug|placebo pill|matching pill twice a day for 12 weeks
12058810|NCT00123110|Drug|placebo injection|matching injection every 4 weeks (e.g. baseline, 4, and 8 weeks)
12058811|NCT00123097|Combination Product|Chlorinated polyethylene elastomer|Chlorinated polyethylene
12058812|NCT00123084|Behavioral|Voice/Respiration Treatment|Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.
12058813|NCT00123084|Behavioral|Speech/Articulation Treatment|Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
12058814|NCT00123058|Behavioral|Nurse administered|Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
12058815|NCT00123058|Device|BP Monitor|Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
12058816|NCT00123045|Behavioral|health education|
12058817|NCT00123032|Behavioral|Diet|Increase the availability of fruits and vegetables, serve recommended portion sizes and reduce availability of excessive energy-dense foods at school cafeterias to improve the diet of participants at school breakfast, lunch and snacks.
12058818|NCT00123032|Procedure|Exercise|Increase active recess time, implement classroom action breaks and increase school PE class time to increase physical activity among participants.
12058819|NCT00123019|Behavioral|Exercise and diet|Advice and measurement only
12058820|NCT00123019|Behavioral|Diet, Weight Reducing|Measurement, advice, environmental and behavioral group interventions
12058821|NCT00123019|Behavioral|Level 1|Annual assessment of weight and waist circumference, questionnaire on work, health issues, advice on diet, physical activity and other health issues.
12058822|NCT00123019|Behavioral|Level 2|All Level 1 activities plus ongoing environmental interventions in worksite and weight management groups in worksite over a 24 month period.
12058823|NCT00123006|Behavioral|Dietary Approaches to Stop Hypertension (DASH)|4 week feeding intervention
12058824|NCT00123006|Behavioral|Control Diet|4 week feeding intervention
12058825|NCT00122993|Behavioral|Healthful eating and food choices behavior change programs and changes in worksite food availability and prices|Food choices and eating behavior programs and environmental changes will be implemented for 18 months in intervention garages.
12058826|NCT00122993|Behavioral|Physical Activity|Physical activity programs are offered at the intervention garages for an 18 month period.
12058827|NCT00122993|Behavioral|Environment|Changes in the food and physical activity environment are made for an 18 month period in intervention garages. These include improving the healthfulness of the foods available in vending machines, and improving the fitness rooms at the garages.
12058828|NCT00122980|Procedure|Red Cell Transfusions|Red Blood Cell Transfusions
12058829|NCT00122980|Procedure|Iron Chelation|Iron Chelation Therapy
12058830|NCT00122980|Drug|Hydroxyurea|Hydroxyurea
12058831|NCT00122980|Procedure|Phlebotomy|Phlebotomy
12058832|NCT00122954|Drug|Fish oil concentrate|fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).
12058833|NCT00122954|Drug|Placebo|soybean oil with 1% fish oil at a daily dose of 6 grams
12058834|NCT00122941|Dietary Supplement|multiple micronutrients|
12058835|NCT00122928|Behavioral|Diet|Healthy Choices in vending machines; Healthy Choices in cafeteria; Catering (Healthy Choices in site meetings, shutdowns, OT meals, etc.); Targeted Messages: Nutrition; Site Based Rewards and Recognition - Individual Employees Weight Management Tracking Program
12058836|NCT00122928|Behavioral|Exercise|Walking Paths/Routes; Weight Management Tracking Program; Targeted Messages: Physical Activity; Site Based Rewards and Recognition - Individual Employees
12058837|NCT00122928|Behavioral|Environmental Obesity Program - Healthy Culture|Site Goal Setting; Work Group Alignment to Site Goals; Reporting to Senior Leadership; Leadership Training; Site Leadership, Cross Discipline Teams, Work Groups, Healthy Culture Focal Point Rewards and Recognition
12058838|NCT00122915|Device|Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator|
12058839|NCT00122889|Drug|Garlic powder with high allicin content|
12058840|NCT00122889|Drug|Garlic powder with low allicin content|
12058841|NCT00122889|Drug|Garlic oil|
12058842|NCT00122889|Drug|Aged garlic|
12058843|NCT00122876|Procedure|Photodynamic therapy|
12058844|NCT00122876|Drug|Talaporfin Sodium|
12058845|NCT00122863|Drug|Duloxetine Hydrochloride|
12058846|NCT00122863|Drug|placebo|
12058847|NCT00122850|Drug|Duloxetine|
12058848|NCT00122850|Drug|venlafaxine|
12058849|NCT00122850|Drug|placebo|
12058850|NCT00122837|Drug|Duloxetine|
12058851|NCT00122837|Drug|venlafaxine|
12058852|NCT00122837|Drug|placebo|
12058853|NCT00122824|Drug|duloxetine hydrochloride|
12058854|NCT00122824|Drug|placebo|
12058855|NCT00122811|Drug|Indapamide SR 1.5mg; Perindopril 2-4mg|
12058856|NCT00122798|Procedure|Stroke treatment|
12058857|NCT00122785|Drug|dexamethasone|
12058858|NCT00122772|Radiation|Radiotherapy|"External Beam Radiation 46Gy in 23 daily fractions
~High Dose Brachytherapy 2 fractions of 9Gy"
12058859|NCT00122772|Radiation|Radiotherapy|"External Beam Radiotherapy 46Gy in 23 daily fractions
~High Dose Brachytherapy 4 fractions of 7Gy"
12058860|NCT00122772|Radiation|Radiotherapy/Cisplatin|"External Beam Radiation 46Gy in 23 daily fractions
~High Dose Brachytherapy 2 fractions of 9Gy
~Cisplatin 40 mg/sqm weekly"
12058861|NCT00122772|Radiation|Radiotherapy/Cisplatin|"External Beam Radiotherapy 46Gy in 23 daily fractions
~High Dose Brachytherapy 4 fractions of 7Gy
~Cisplatin 40mg/sqm weekly"
12058862|NCT00122759|Drug|ketamine|
12058863|NCT00122746|Radiation|Radiotherapy alone|EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
12058864|NCT00122746|Radiation|Radiotherapy with cisplatin|EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly cisplatin 30 mg/m2 during EBRT
12058865|NCT00122733|Drug|loxapine|
12058866|NCT00122720|Drug|Darbepoetin Alfa|
12058867|NCT00122707|Device|catheters|
12058868|NCT00122694|Drug|carbon monoxide|
12058869|NCT00122681|Biological|Cervarix™|Intramuscular injection, 3 doses
12058870|NCT00122681|Biological|Havrix™-based investigational formulation|Intramuscular injection, 3 doses
12058871|NCT00122668|Drug|non-nucleoside reverse transcriptase inhibitors|
12058872|NCT00122668|Drug|nucleoside reverse transcriptase inhibitors|
12058873|NCT00122668|Drug|protease inhibitor|
12058874|NCT00122655|Drug|non-nucleoside reverse transcriptase inhibitors|
12058875|NCT00122655|Drug|nucleoside reverse transcriptase inhibitors|
12058876|NCT00122655|Drug|protease inhibitors|
12058877|NCT00122642|Procedure|Alcohol-lock|The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
12058878|NCT00122642|Drug|placebo-lock|The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
12058879|NCT00122629|Drug|peg-interferon alfa-2b|
12058880|NCT00122629|Drug|ribavirin|
12058881|NCT00122629|Drug|amantadine|
12058882|NCT00122616|Biological|Peginterferon alpha-2a (Pegasys®)|Peg-Interferon Alpha2a by subcutaneous injection, 180µg, once weekly
12058883|NCT00122616|Drug|Ribavirin|Ribavirin: tablet oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over 75 kg, once daily
12058884|NCT00122616|Drug|HIV antiretroviral therapy|All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs
12058885|NCT00122616|Drug|HIV antiretroviral therapy|All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs
12058886|NCT00122603|Drug|Fosamprenavir|ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)
12058887|NCT00122603|Drug|Saquinavir|ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)
12058888|NCT00122590|Drug|nelfinavir|
12058889|NCT00122590|Drug|lopinavir/r|
12058890|NCT00122590|Drug|indinavir|
12058891|NCT00122590|Drug|ritonavir|
12058892|NCT00122577|Drug|Tenofovir|
12058893|NCT00122577|Drug|Atazanavir|
12058894|NCT00122577|Drug|Ritonavir|
12058895|NCT00122564|Biological|HIV-1 gp 160|
12058896|NCT00122564|Biological|DC-Chol|
12058897|NCT00122551|Procedure|Intermittent antiretroviral therapy|
12058898|NCT00122538|Drug|Efavirenz (EFV)|
12058899|NCT00122538|Drug|Lamivudine (3TC)|
12058900|NCT00122538|Drug|Didanosine (ddI)|
12058901|NCT00122525|Procedure|Male Circumcision|
12058902|NCT00122512|Drug|Tenofovir Disoproxil Fumarate|
12058903|NCT00122499|Drug|tadalafil|
12058904|NCT00122486|Drug|Tenofovir Disoproxil Fumarate|
12058905|NCT00122473|Drug|Imatinib (Glivec)|
12059032|NCT00121446|Procedure|percutaneous coronary intervention|
12058906|NCT00122460|Drug|Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks
12058907|NCT00122460|Drug|Platinum (Cisplatin or Carboplatin) + 5-FU|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks
12058908|NCT00122447|Drug|Aspirin|325 mg PO QD
12058909|NCT00122447|Drug|Alpha lipoic acid|600 mg PO BID
12058910|NCT00122447|Drug|Olmesartan|40 mg PO QD
12058911|NCT00122447|Drug|Placebo|"Identical placebo for each active comparator:
~placebo aspirin 325 mg PO QD; placebo for alpha lipoic acid 600 mg PO BID; placebo for olmesartan 40 mg PO QD"
12058912|NCT00122434|Drug|BEA 2180 BR|
12058913|NCT00122434|Drug|tiotropium|
12058914|NCT00122421|Behavioral|Pharmacist recommendations to primary care providers|recommendations based on chart review by pharmacist, given to pcp at time of visit
12058915|NCT00122421|Other|pharmacist recommendations|recommendations based on chart review by pharmacist, given to pcp at time of visit
12058916|NCT00122408|Dietary Supplement|Ergyphilus|5 pills a day of Ergyphilus or placebo
12058917|NCT00122395|Behavioral|Screening via pen and paper|
12058918|NCT00122395|Behavioral|Screening via audiotape|
12058919|NCT00122382|Drug|Abatacept|abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
12058920|NCT00122382|Drug|placebo|placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months
12058921|NCT00122382|Drug|methotrexate|Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
12058922|NCT00122369|Behavioral|Self-hypnotic Relaxation|A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.
12058923|NCT00122369|Behavioral|Empathic Attention|A research assistant displayed defined behaviors of empathic attention.
12058924|NCT00122356|Drug|Alendronate sodium|70mg tablets, once weekly
12058925|NCT00122343|Drug|ridaforolimus|AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks. A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
12058926|NCT00122330|Drug|eculizumab|
12058927|NCT00122317|Drug|eculizumab|
12058928|NCT00122304|Drug|eculizumab|
12058929|NCT00122291|Drug|Capecitabine|
12058930|NCT00122291|Procedure|Pelvic radiation|
12058931|NCT00122278|Drug|Dexamethasone|Dexamethasone 10mg IV
12058932|NCT00122278|Other|Placebo|Placebo Dexamethasone 10mg IV
12058933|NCT00122226|Drug|Lopinavir/ritonavir + zidovudine + lamivudine|
12058934|NCT00122226|Drug|Lopinavir/ritonavir + nevirapine|
12058935|NCT00122213|Behavioral|Behavior change on physical activity and diet|
12058936|NCT00122187|Device|Electronic Consult System|Consult system is an event notification system programmed to function within the VA electronic medical record system.
12058937|NCT00122174|Behavioral|Stress Busting Program for family caregivers|
12058938|NCT00122161|Behavioral|ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers|
12058939|NCT00122161|Behavioral|Profiling performance|
12058940|NCT00122148|Behavioral|Feedback on provision of care|
12058941|NCT00122135|Other|Values Inventory (VI)|The Values Inventory was given to patients for self-administration while they were awaiting their clinic appointment. They were instructed to bring it to their physician's attention right at the beginning of their clinic visit.
12058942|NCT00122122|Behavioral|Enhanced Pharmacy Care|
12058943|NCT00122109|Behavioral|12 sessions Anger Management Therapy.|Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills.
12058944|NCT00122096|Drug|valdecoxib|
12058945|NCT00122083|Device|Health education information|
12058946|NCT00122070|Drug|Quetiapine Fumarate|Dosage can vary from 50 to 150 mg at PI's discretion
12058947|NCT00122057|Drug|antibiotic treatment|
12058948|NCT00122044|Drug|trihexyphenidyl|
12058949|NCT00122031|Device|Deep Brain Stimulation with Medtronic Activa Neurostimulator|Deep brain stimulation (DBS) at 130 Hz
12058950|NCT00122018|Drug|N-acetylcysteine|
12058951|NCT00122018|Drug|fenoldopam|
12058952|NCT00122005|Biological|GM-CSF gene transduced allogeneic vaccine GVAX|
12058953|NCT00121992|Drug|Docetaxel|
12058954|NCT00121992|Drug|5-fluorouracil|
12058955|NCT00121992|Drug|Doxorubicin|
12058956|NCT00121992|Drug|Cyclophosphamide|
12058957|NCT00121979|Drug|Racivir, a non-nucleoside reverse transcriptase inhibitor|
12058958|NCT00121966|Drug|Insulin Aspart|
12058959|NCT00121966|Drug|Insulin NPH|
12058960|NCT00121966|Drug|Metformin|
12058961|NCT00121966|Drug|Rosiglitazone|
12058962|NCT00121953|Drug|Rosiglitazone|
12058963|NCT00121940|Behavioral|Guided Care|"Specially trained registered nurse (Guided Care Nurse) based in a primary care practice collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients: comprehensive assessment and care planning; best practices for chronic conditions; self-management; healthy lifestyles; coordinating care; educating and supporting unpaid caregivers; and accessing community resources."
12058964|NCT00121927|Behavioral|Atkins diet (15 grams/day carbohydrates)|
12058965|NCT00121914|Procedure|percutaneous ethanol instillation (PEI)|
12058966|NCT00121901|Drug|glyceryl nitrate|
12058967|NCT00121888|Behavioral|Prolonged Exposure Therapy|
12058969|NCT00121875|Drug|somatropin (rDNA)|"Form/Strength: 10 mg aqueous suspension; 5 mg/ml
~Dosage/Frequency: 0.35 mg/kg/week, daily divided doses
~Duration: 6 months with 3-month washout period"
12058970|NCT00121862|Biological|Leish-111f + MPL-SE vaccine|
12058971|NCT00121849|Biological|Leish-111f + MPL-SE vaccine|
12058972|NCT00121836|Drug|Capecitabine|1000 mg/m² PO BID on Days 1-15 of each 3-week cycle
12058973|NCT00121836|Drug|Bevacizumab|15 mg IV on Day 1 of each 3-week cycle
12058974|NCT00121823|Biological|FP9 ME-TRAP|
12058975|NCT00121823|Biological|MVA ME-TRAP|
12058976|NCT00121810|Drug|mycophenolate mofetil [CellCept]|1.0-1.5 g oral dose twice daily
12058977|NCT00121810|Drug|Corticosteroids|As prescribed
12058978|NCT00121810|Drug|Calcineurin inhibitors|As prescribed
12058979|NCT00121810|Drug|Sirolimus|As prescribed
12058980|NCT00121797|Procedure|urine culture|
12058981|NCT00121797|Drug|antibiotics according to culture|
12058982|NCT00121784|Drug|mycophenolate mofetil [CellCept]|1
12058983|NCT00121771|Biological|FP9 CS|
12058984|NCT00121771|Biological|MVA CS|
12058985|NCT00121758|Biological|LIPO-5|
12058986|NCT00121745|Genetic|Rexin-G Dose 1|Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose I 3- 6 Days 1-7, 15-21 7.5 x 10e9 cfu 500 ml
12058987|NCT00121745|Genetic|Rexin-G Dose 2|Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose II 3- 6 Days 1-7, 15-21 1.1 x 10e10 cfu 500 ml
12058988|NCT00121745|Genetic|Rexin-G Dose 3|"Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose
~III 3- 6 5 days/wk x 4 wks 3.0 x 10e10 cfu 500 ml"
12058989|NCT00121745|Genetic|Rexin-G Dose 4|"Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose
~IV 3- 6 5 days/wk x 4 wks 8.0 x 10e10 cfu 500 ml"
12058990|NCT00121732|Drug|E7974|Maximum tolerated dose = 0.15 mg/m^2 administered on Days 1, 8, 15 of 28-day cycle.
12058991|NCT00121732|Drug|E7974|Maximum tolerated dose = 0.37 mg/m^2 administered on Days 1 and 8 of 21-day cycle.
12058992|NCT00121719|Drug|Lenvatinib|Lenvatinib tablets taken orally, once daily.
12058993|NCT00121706|Behavioral|Condition A (see detailed summary)|
12058994|NCT00121706|Behavioral|Condition B (see detailed summary)|
12058995|NCT00121706|Behavioral|Condition C (see detailed summary)|
12058996|NCT00121693|Behavioral|Music therapy (listening to specific music)|Listening to Music
12058997|NCT00121680|Drug|E7080|Oral.
12058998|NCT00121667|Drug|Saxagliptin + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
12058999|NCT00121667|Drug|Saxagliptin + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
12059000|NCT00121667|Drug|Saxagliptin + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
12059001|NCT00121667|Drug|Placebo + Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)
12059002|NCT00121667|Drug|Pioglitazone|Tablets, Oral, 15 - 45 mg (as needed for rescue)
12059003|NCT00121654|Device|Spinal cord stimulation|Under sterile conditions and local anesthesia, the epidural space is punctured at the level of T5-T6 and a quadripolar electrode catheter is introduced and advanced under X-ray control into the epidural space. A suitable position for the electrode catheter is sought for, corresponding to the site where a prickling sensation (paresthesia) is felt and covers the area of radiation of angina pain under neurostimulation. The electrode catheter is connected to an internal pulse generator placed in a subcutaneous abdominal or gluteal pocket through an extension lead connected to the electrode by subcutaneous tunneling.
12059004|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT])
12059005|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)
12059006|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)
12059007|NCT00121641|Drug|Placebo matching Saxagliptin|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)
12059008|NCT00121641|Drug|Metformin|Tablets, Oral, 500 mg, daily (42 months LT)
12059009|NCT00121641|Drug|Placebo matching Metformin|Tablets, Oral, 0 mg, daily (42 months LT)
12059010|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label
12059011|NCT00121641|Drug|Metformin|Tablets, Oral, 500-2000 mg (as needed for rescue)
12059012|NCT00121628|Drug|AMG 706|
12059013|NCT00121615|Drug|etanercept|
12059014|NCT00121602|Drug|Darbepoetin Alfa|Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment. Frequency either once a week or once every two weeks, frequency may not change for duration of study. Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study. Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.
12059015|NCT00121589|Drug|Lutein|
12059016|NCT00121563|Drug|Thalidomide, Ibuprofen or Diazepam|
12059017|NCT00121550|Drug|clarithromycin|
12059018|NCT00121537|Device|Wound Care -Wound Vacuum Assisted Closure (VAC)|
12059019|NCT00121537|Procedure|Wound Care - Wet to Dry Dressing Changes|
12059020|NCT00121524|Drug|Epinephrine|Epinephrine 1 mg is given iv. every 3 min during CPR
12059021|NCT00121524|Device|Intravenous needle|An intravenous needle in placed as soon as possible during CPR
12059022|NCT00121524|Drug|Atropine|Atropine 3 mg iv in initial systole
12059023|NCT00121524|Drug|Amiodarone|amiodarone 300 mg iv after repeated failed defibrillation attempts
12059024|NCT00121511|Drug|Efudex (5-fluorouracil)|
12059025|NCT00121498|Drug|Lidocaine (local anesthetics) 20 ml of 1 % subcutaneously|
12059026|NCT00121485|Device|Left Ventricular Assist System (LVAS)|Implantation of left ventricular assist device for hemodynamic support
12059027|NCT00121472|Device|Thoratec HeartMate II Left Ventricular Assist System (LVAS)|Implantation of ventricular assist device to provide hemodynamic support
12059028|NCT00121459|Device|Ortho All-Flex diaphragm and Replens lubricant gel|
12059029|NCT00121446|Drug|tenecteplase|
12059030|NCT00121446|Drug|enoxaparin|
12059031|NCT00121446|Drug|clopidogrel|
12059033|NCT00121433|Drug|leptin|
12059034|NCT00121420|Drug|Motexafin gadolinium|
12059035|NCT00121407|Drug|Visudyne for injection|
12059036|NCT00121394|Procedure|Chlorhexidine vaginal and infant wash|
12059037|NCT00121381|Drug|Pimecrolimus plus topical corticosteroid (TCS)|Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
12059038|NCT00121381|Drug|Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)|twice daily administration
12059039|NCT00121355|Device|safety glide|
12059040|NCT00121355|Device|autocover needle|
12059041|NCT00121329|Drug|Intrauterine lidocaine infusion 4%|
12059042|NCT00121316|Drug|Pimecrolimus|Pimecrolimus Cream 1 %
12059043|NCT00121316|Drug|Placebo|Vehicle cream (placebo cream)
12059044|NCT00121303|Drug|cytarabine|
12059045|NCT00121303|Drug|daunorubicin hydrochloride|
12059046|NCT00121303|Drug|gemtuzumab ozogamicin|
12059047|NCT00121290|Drug|SJG-136|Given IV
12059048|NCT00121290|Other|laboratory biomarker analysis|Correlative studies
12059049|NCT00121290|Other|pharmacological study|Correlative studies
12059050|NCT00121277|Drug|capecitabine|
12059051|NCT00121277|Drug|vorinostat|
12059052|NCT00121264|Drug|sorafenib tosylate|Given orally
12059053|NCT00121264|Drug|tanespimycin|Given IV
12059054|NCT00121264|Other|laboratory biomarker analysis|Correlative studies
12059055|NCT00121264|Other|pharmacological study|Correlative studies
12059056|NCT00121264|Procedure|magnetic resonance imaging|Correlative studies
12059057|NCT00121251|Drug|Capecitabine|Given PO
12059058|NCT00121251|Drug|Gemcitabine Hydrochloride|Given IV
12059059|NCT00121251|Drug|Sorafenib Tosylate|Given PO
12059060|NCT00121238|Drug|cilengitide|Given IV
12059061|NCT00121225|Drug|vorinostat|Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
12059062|NCT00121212|Procedure|carbon-11 acetate PET scan|
12059063|NCT00121199|Biological|rituximab|Given IV
12059064|NCT00121199|Biological|bevacizumab|Given IV
12059065|NCT00121199|Drug|cyclophosphamide|Given IV
12059066|NCT00121199|Drug|doxorubicin hydrochloride|Given IV
12059067|NCT00121199|Drug|vincristine sulfate|Given IV
12059068|NCT00121199|Drug|prednisone|Given PO
12059069|NCT00121199|Other|laboratory biomarker analysis|Correlative studies
12059070|NCT00121186|Drug|fludarabine phosphate|30 mg/m^2 on days -6 to -2 (2-6 days before transplant).
12059071|NCT00121186|Drug|melphalan|70 mg/m^2 on days -3 and -2 (2-3 days before transplant).
12059072|NCT00121186|Drug|methotrexate|5 mg/m^2 on days 1, 3, and 7 post-transplant.
12059073|NCT00121186|Drug|tacrolimus|0.03 mg/kg bid on days -3 to 100 post-transplant.
12059074|NCT00121186|Procedure|allogeneic bone marrow transplantation|if donor bone marrow stem cells are harvested
12059075|NCT00121186|Procedure|peripheral blood stem cell transplantation|if donor peripheral blood stem cells are harvested
12059076|NCT00121173|Biological|pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine|recombinant DNA vaccine
12059077|NCT00121160|Behavioral|Cognitive Behavioral Stress Management (CBSM) group intervention|Participants will meet in closed, structured groups of 4 to 6 women for ten weekly, 2-hour group sessions. The intervention employs CBSM techniques interwoven with information in a supportive group format. The information portion of the intervention focuses on learning to cope with daily stressors, and learning about optimal use of social support. Group members and group leaders are used as role models for effective coping and the use of social support. The groups also encourage emotional expression and provide an opportunity to practice techniques learned in the group and experience social support. Avoidance coping is discouraged, and acceptance and reframing are instead encouraged as coping responses. Health behavior change, framed as a coping technique, will also be discussed using motivational interviewing techniques. Each week participants also experience a different relaxation technique. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.
12059078|NCT00121147|Drug|Travatan|
12059079|NCT00121147|Drug|Azopt|
12059080|NCT00121147|Drug|Alphagan P|
12059081|NCT00121134|Drug|Bevacizumab|Group A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months
12059082|NCT00121134|Drug|Cyclophosphamide|Once a day for 6 months
12059083|NCT00121134|Drug|Methotrexate|Twice daily for the first two days of every week for 6 months
12059084|NCT00121134|Drug|Capecitabine|"Capecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks)
~Bevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles)"
12059085|NCT00121121|Biological|Lipopeptides LIPO-4|
12059086|NCT00121108|Biological|MEDI-524|15 mg/kg motavizumab administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season
12059087|NCT00121108|Other|Placebo|15 mg/kg placebo administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.
12059088|NCT00121095|Drug|Samarium Sm-153 lexidronam + Docetaxel|1 mCi/kg Sm153 + 75 mg/m2 docetaxel
12059089|NCT00121069|Drug|Escitalopram|
12059090|NCT00121056|Drug|Enbrel®|
12059091|NCT00121056|Drug|Kineret®|
12059092|NCT00121043|Device|SimpleJectTM|
12059093|NCT00121043|Drug|Kineret® (Anakinra)|
12059094|NCT00121030|Drug|darbepoetin alfa|
12059095|NCT00121030|Drug|recombinant human erythropoietin (rHuEPO)|
12059096|NCT00121017|Drug|Kaletra (lopinavir/ritonavir)|
12059097|NCT00121017|Drug|Sustiva (efavirenz)|
12059098|NCT00121017|Drug|Truvada (emtricitabine/tenofovir disoproxil fumarate)|
12059099|NCT00121004|Behavioral|Advance Directive Selection|
12059100|NCT00120991|Procedure|Coronary artery bypass grafting|
12059101|NCT00120978|Drug|Advair|
12059102|NCT00120978|Drug|Flovent|
12059103|NCT00120965|Device|AutoPulse|Standard device settings
12059104|NCT00120965|Other|Manual CPR|Manual CPR
12059105|NCT00120952|Device|Bi-Metric femoral implant (titanium versus cobalt-chromium)|
12059106|NCT00120939|Drug|Motexafin Gadolinium|
12059107|NCT00120926|Drug|Parenteral Nutrition|
12059108|NCT00120913|Drug|Birth control pills|
12059109|NCT00120900|Drug|GW406381|
12059110|NCT00120887|Drug|Atorvastatin|
12059111|NCT00120874|Behavioral|Individualized management of AD including caregiver training|Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
12059112|NCT00120874|Drug|Memantine|Patients receive 10 milligrams of memantine twice daily.
12059113|NCT00120861|Drug|valopicitabine|
12059114|NCT00120861|Drug|pegylated interferon|
12059115|NCT00120861|Drug|ribavirin|
12059116|NCT00120848|Biological|HPV 16/18 VLP AS04|
12059117|NCT00120835|Drug|valopicitabine|
12059118|NCT00120835|Drug|pegylated interferon|
12059119|NCT00120822|Drug|Folic acid|
12059120|NCT00120809|Drug|Sulfadoxine-pyrimethamine|
12059121|NCT00120796|Drug|Lamivudine|
12059122|NCT00120796|Biological|Recombinant hepatitis B surface antigen|
12059123|NCT00120783|Drug|Indinavir|
12059124|NCT00120783|Drug|Lamivudine|
12059125|NCT00120783|Drug|Ritonavir|
12059126|NCT00120770|Drug|Cellulose Sulfate Vaginal Gel (Microbicide)|
12059127|NCT00120757|Drug|Alendronate|
12059128|NCT00120744|Drug|Ondansetron Oral Disintegrating Tablet|
12059129|NCT00120731|Drug|Potassium Citrate|
12059130|NCT00120731|Drug|Acetazolamide|
12059131|NCT00120731|Behavioral|Diet low in oxalate and purines|
12059132|NCT00120718|Drug|fasudil|
12059133|NCT00120705|Drug|darbepoetin alfa|
12059134|NCT00120692|Drug|Darbepoetin Alfa|
12059135|NCT00120692|Drug|Recombinant Human Erythropoietin|
12059136|NCT00120679|Drug|darbepoetin alfa|
12059137|NCT00120679|Drug|recombinant human erythropoietin (rHuEPO)|
12059138|NCT00120653|Drug|Metoclopramide|
12059139|NCT00120640|Drug|17 hydroxyprogesterone caproate intramuscular injections|
12059140|NCT00120627|Behavioral|Mantram Repetition Program (MRP) plus Usual Care|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
12059141|NCT00120627|Other|Usual care consisting of medication and case management|Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
12059142|NCT00120614|Behavioral|Premature infant behavior and development information|
12059143|NCT00120614|Behavioral|Parental activities to support premature infant information|
12059144|NCT00120601|Drug|Naltrexone|
12059145|NCT00120601|Drug|Acamprosate|
12059146|NCT00120588|Drug|magnesium|
12059147|NCT00120575|Procedure|hemofiltration|
12059148|NCT00120562|Procedure|Gastric Bypass Surgery|
12059149|NCT00120549|Procedure|Assisted embryo hatching|
12059150|NCT00120536|Drug|vildagliptin|
12059151|NCT00120523|Drug|Pimecrolimus|Pimecrolimus cream 1 %
12059152|NCT00120523|Drug|Topical corticosteroids|TCS
12059153|NCT00120510|Drug|Efavirenz|Non-nucleoside reverse transcriptase inhibitor dosed at 600mg taken by mouth every 24 hours at bedtime
12059154|NCT00120510|Drug|Lamivudine/Zidovudine|Nucleoside reverse transcriptase inhibitor dosed at 150mg/300mg fixed dose combination taken by mouth every 12 hours
12059155|NCT00120497|Drug|somatropin (rDNA)|"Dosage form/strength: 13.8 mg powder in 2-chamber cartridge; reconstitutes to 10 mg/ml
~Dosage regimen: 0.48 mg/kg/week
~Route/rate of administration: subcutaneous injection, daily dose"
12059156|NCT00120484|Drug|Vitamin B12|
12059157|NCT00120471|Drug|Tenofovir disoproxil fumarate|600-mg tablet taken orally once daily
12059158|NCT00120471|Drug|Tenofovir disoproxil fumarate|4-mg/kg oral suspension taken at birth and on Days 3 and 5 after birth
12059159|NCT00120471|Drug|Tenofovir disoproxil fumarate|6-mg/kg oral suspension taken at birth and daily for 7 days after birth
12059160|NCT00120458|Dietary Supplement|Black cohosh|"32 to 128 mg (black cohosh)
~1 to 4 capsules daily (placebo)"
12059161|NCT00120445|Procedure|air|0.3 ml of filtered air
12059162|NCT00120445|Procedure|expansile gas|0.3 ml of perfluoropropane gas
12059163|NCT00120432|Drug|1% tropicamide and 10% phenylephrine|single dose vs three doses of 1%tropicamide and 10%phenylephrine
12059164|NCT00120419|Drug|mycophenol mofetil (MMF, Cellcept®) 500 mg BID|
12059165|NCT00120406|Device|Zilver® PTX™ Drug Eluting Vascular Stent|Stenting of the Superfemoropopliteal Artery
12059166|NCT00120406|Procedure|Angioplasty|Angioplasty of the Superfemoropopliteal Artery
12059167|NCT00120393|Drug|atazanavir/ritonavir +2 NRTIs (immediate Switch Group)|Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
12059168|NCT00120393|Drug|LPV/r +2 NRTIs (Delayed/optional Switch Group)|Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.
12059169|NCT00120380|Drug|Aerosolized iloprost|
12059170|NCT00120380|Drug|Placebo|
12059171|NCT00120367|Drug|Enfuvirtide|
12059172|NCT00120367|Drug|Tenofovir-Emtricitabine|
12059173|NCT00120354|Procedure|Blood Testing|
12059174|NCT00120354|Procedure|Percutaneous Liver Biopsy|
12059175|NCT00120354|Procedure|Lamivudine Therapy|
12059176|NCT00120341|Device|Anodyne Therapy System|
12059177|NCT00120328|Drug|SPP301|
12059178|NCT00120315|Drug|esomeprazole|esomeprazole, original Nexium, 40 mg pills Up to once a day
12059179|NCT00120315|Procedure|Helicobacter pylori c-13 breath test|Breath test done at entry to find Helicobacter pylori
12059180|NCT00120302|Drug|Pimecrolimus|Pimecrolimus cream 1 %
12059181|NCT00120302|Drug|Placebo|Matching vehicle cream
12059182|NCT00120289|Drug|Extended release niacin|2,000 mg/day or 1,500 mg/day if higher dose not tolerated
12059183|NCT00120289|Drug|Simvastatin|Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
12059184|NCT00120276|Device|Less invasive mitral valve repair|
12059185|NCT00120263|Procedure|Plasma Exchange|
12059186|NCT00120250|Drug|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
12059187|NCT00120237|Drug|Misoprostol|600 mcg oral misoprostol administered during third stage of labor
12059188|NCT00120211|Radiation|Accelerated Radiotherapy Fractionation|Radiation Therapy 6 fractions per week
12059189|NCT00120211|Radiation|Accelerated Radiotherapy Fractionation|Radiotherapy 5 fractions per week
12059190|NCT00120198|Drug|CDOP plus rituximab|
12059191|NCT00120185|Drug|Interleukin-2|
12059192|NCT00120172|Drug|oxaliplatin, capecitabine, bevacizumab|
12059193|NCT00120133|Drug|Atorvastatin|
12059194|NCT00120120|Drug|Lenalidomide (CC-5013)|Lenalidomide 2-5 mg capsules taken one time per day
12059195|NCT00120107|Drug|Black Tea|
12059196|NCT00120081|Biological|Na-ASP-2/Alhydrogel Hookworm Vaccine|The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.
12059197|NCT00120081|Biological|Saline placebo|Inactive saline placebo control
12059198|NCT00120068|Behavioral|Nursing inservices|
12059199|NCT00120068|Procedure|Academic detailing to MDs; concurrent review and feedback|
12059200|NCT00120055|Drug|Atorvastatin (Lipitor)|
12059201|NCT00120042|Drug|Misoprostol|600 mcg misoprostol swallowed after delivery of fetus
12059202|NCT00120042|Drug|Oxytocin|10 units oxytocin administered intramuscularly after delivery fetus
12059203|NCT00120029|Behavioral|weight loss counseling|
12059204|NCT00120016|Behavioral|dietary counseling|telephone counseling
12059205|NCT00120003|Drug|Candesartan Cilexetil|4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
12059206|NCT00120003|Drug|Placebo|4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
12059207|NCT00119990|Drug|Icodextrin (dialysate)|2 liter of extraneal are given with one fill for 4 hours.
12059208|NCT00119990|Drug|Physioneal (dialysate) 1.36% and 2.27%|2 liter of Physioneal of 1.36% or 3.86% are given with one fill for 4 hours one two different days.
12059209|NCT00119977|Procedure|1 Periacetabular osteotomy|pelvic osteotomy to increase acetabular coverage
12059210|NCT00119964|Behavioral|internet based weight management tools|
12059211|NCT00119951|Behavioral|Participation on the ACOR Listserv|
12059212|NCT00119938|Behavioral|Access to online patient portal|
12059213|NCT00119925|Behavioral|patient education|patient leaflets about national guideline contents
12059214|NCT00119925|Behavioral|professional audit and feedback (guideline adherence)|feedback on current practice according to quality indicators
12059215|NCT00119925|Behavioral|professional education (communication/shared decision making)|educational tools for professionals concerning communication and shared decision making
12059216|NCT00119925|Other|information tools|tools and checklists to improve information provision
12059217|NCT00119912|Procedure|A 1 Intervention arm Flex Sig|Screening by flexible sigmoidoscopy
12059218|NCT00119912|Procedure|A 2 Intervention arm Flex Sig + iFOBT|In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT
12059219|NCT00119899|Procedure|FDG-PET scan|
12059220|NCT00119886|Drug|Botulinum toxin|
12059221|NCT00119873|Biological|VRC-HIVADV014-00-VP|
12059222|NCT00119847|Procedure|PCI|
12059223|NCT00119847|Drug|Optimal Medical Therapy|Guideline-directed drug therapies after MI
12059224|NCT00119834|Device|Mechanical Circulatory Support Device (MCSD)|INTERMACS is an observational registry of adult and pediatric patients with end stage heart failure that receive a legally utilized Mechanical Circulatory Support Device.
12059225|NCT00119821|Behavioral|Weight Reducing Diet|Behavioral intervention
12059226|NCT00119821|Behavioral|Exercise|Moderate exercise implemented plus behavioral intervention.
12059227|NCT00119821|Behavioral|Smoking Cessation|"Nicotine Patch in dosages given based on number of cigarettes per day smoked. 21 mg patch, 14 mg patch, 7 mg patch for total of 6 weeks duration of therapy.
~NRT gum is being provided to assist with relapse prevention. At the randomization visit the participant is given one (1) box of 2mg NRT gum, which consists of (110) pieces. The participant may request up to two (2) more boxes, for a maximum of three (3) boxes per participant."
12059228|NCT00119795|Behavioral|Exercise|Increase Physical Activity to 150 min/wk
12059229|NCT00119795|Behavioral|Weight Loss|Lose 7-10% of body weight and increase physical activity to 150 min/wk
12059230|NCT00119795|Behavioral|Health Education Control|Lectures on information relevant to successful aging
12059231|NCT00119782|Behavioral|Diet|A dietary intervention that will promote lower calorie intake
12059232|NCT00119782|Behavioral|Exercise|A physical activity intervention combining increased daily physical activity and regular, structured exercise
12059233|NCT00119782|Behavioral|Environment|Increase worksite access to both healthy foods and physical activity
12059234|NCT00119769|Drug|Placebo|Placebo, 0.7 mg/day injected subcutaneously
12059235|NCT00119769|Drug|Genotropin (human recombinant Growth hormone)|Genotropin, 0.7 mg/day injected subcutaneously
12059236|NCT00119756|Drug|paliperidone palmitate|
12059237|NCT00119743|Biological|undecavalent pneumococcal-protein D conjugate vaccine|
12059238|NCT00119730|Drug|Fludarabine|Given on days 1-3 of each 28-day cycle
12059239|NCT00119730|Drug|Mitoxantrone|Given on day 1 of each 28-day cycle
12059240|NCT00119730|Drug|Rituximab|Given on day 1 of each 28-day cycle
12059316|NCT00119262|Drug|paclitaxel|Given IV
12059317|NCT00119262|Biological|filgrastim|Given SC
12059318|NCT00119262|Biological|pegfilgrastim|Given SC
12059319|NCT00119262|Radiation|radiation therapy|Undergo radiation therapy
12059320|NCT00119262|Drug|tamoxifen citrate|Given orally
12059241|NCT00119730|Drug|Zevalin|After two cycles if there is no disease progression, zevalin treatment will be given. Rituximab will be given followed by an imaging dose of zevalin. Two or three scans will be performed over a week to determine if it is safe to give the full treatment dose of zevalin. The treatment dose is given with the second infusion or rituximab, seven days after the first dose.
12059242|NCT00119717|Device|NeuroFlo™ catheter|45 minute treatment
12059243|NCT00119717|Other|Control|ASA Guidelines
12059244|NCT00119704|Drug|Botulinum toxin A injection or normal saline|
12059245|NCT00119691|Drug|Nesiritide|Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.
12059246|NCT00119678|Drug|Abatacept|Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months
12059247|NCT00119678|Drug|Placebo|Injectable, intravenous, 0 mg, every 28 days, 12 months
12059248|NCT00119678|Drug|Prednisone|Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
12059249|NCT00119678|Drug|Abatacept|Injectable, intravenous, 10 mg/kg, every 28 days
12059250|NCT00119665|Drug|MF101|
12059251|NCT00119652|Drug|quetiapine fumarate (Seroquel)|
12059252|NCT00119652|Drug|paroxetine|
12059253|NCT00119652|Behavioral|mood stabilizing activity|
12059254|NCT00119639|Drug|Sorafenib (BAY43-9006, Nexavar)|All subjects were given a open-label, single dose of 400mg sorafenib
12059255|NCT00119626|Drug|NXY-059|
12059256|NCT00119613|Drug|placebo|placebo
12059257|NCT00119613|Drug|darbepoetin alfa|darbepoetin alfa
12059258|NCT00119600|Drug|AMG 114|
12059259|NCT00119587|Drug|darbepoetin alfa|
12059260|NCT00119574|Procedure|Collaborative Chronic Illness Model|
12059261|NCT00119561|Behavioral|Telephone Support|Each telephone support group of 5 caregivers and a group leader met 14 times over a year. The hour calls were semi-structured with an educational component and a support component, led by a trained Group Leader. Topics included knowledge of dementia, safety, caregiver health and well being, communication, managing behavioral challenges and caregiver stress and coping.
12059262|NCT00119548|Other|Rates of HIV testing and receipt of results|Rates of HIV testing and receipt of results
12059263|NCT00119548|Other|Sexual risk reduction; HIV knowledge improvement|Sexual risk reduction; HIV knowledge improvement
12059264|NCT00119548|Other|Rates of HIV testing and receipt of results|Rates of HIV testing and receipt of results
12059265|NCT00119548|Other|Sexual risk reduction; HIV knowledge improvement|Sexual risk reduction; HIV knowledge improvement
12059266|NCT00119548|Other|Rates of HIV testing and receipt of results|Rates of HIV testing and receipt of results
12059267|NCT00119548|Other|Sexual risk reduction; HIV knowledge improvement|Sexual risk reduction; HIV knowledge improvement
12059268|NCT00119535|Behavioral|Implementation of Proactive Diabetes Eye Care Program|
12059269|NCT00119509|Procedure|HPV DNA testing|
12059270|NCT00119509|Procedure|Conventional management (repeat Pap smear at 6 months)|
12059271|NCT00119509|Procedure|Decision aid with choice of management|
12059272|NCT00119496|Drug|rosiglitazone|oral tablet, 4mg bd for 4 weeks
12059273|NCT00119496|Drug|theophylline|Oral theophylline, 200mg bd
12059274|NCT00119496|Drug|beclomethasone|inhaled beclomethasone, 200mcg bd
12059275|NCT00119496|Drug|inhaled beclomethasone and oral theophylline|inhaled beclomethasone (400mcg/day), oral theophylline (400mg/day)
12059276|NCT00119483|Drug|Nebido (Testosterone Undecanoate)|
12059277|NCT00119470|Procedure|EUS-FNA|
12059278|NCT00119470|Procedure|Conventional Surgical Technique|
12059279|NCT00119457|Drug|TTP889|
12059280|NCT00119444|Procedure|Periacetabular osteotomy|osteotomy of the pelvis to increase acetabular coverage
12059281|NCT00119431|Drug|C1 inhibitor concentrate|
12059282|NCT00119418|Drug|TU 025 Keishi Bukuryo Gan|
12059283|NCT00119392|Biological|rituximab|Given IV
12059284|NCT00119392|Drug|cyclosporine|Given orally
12059285|NCT00119392|Drug|fludarabine phosphate|Given IV
12059286|NCT00119392|Drug|mycophenolate mofetil|Given orally
12059287|NCT00119392|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
12059288|NCT00119392|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
12059289|NCT00119392|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo transplantation
12059290|NCT00119392|Radiation|total-body irradiation|Undergo TBI
12059291|NCT00119379|Drug|NucleomaxX|NucleomaxX 36 grams TID every other day
12059292|NCT00119379|Drug|Tenofovir Disoproxil Fumarate|Switch of thymidine nucleoside reverse transcriptase inhibitors to Tenofovir Disoproxil Fumarate
12059293|NCT00119366|Radiation|iodine I 131 monoclonal antibody BC8|Given IV
12059294|NCT00119366|Drug|fludarabine phosphate|Given IV
12059295|NCT00119366|Radiation|total-body irradiation|Undergo TBI
12059296|NCT00119366|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo PBSC transplantation
12059297|NCT00119366|Procedure|peripheral blood stem cell transplantation|Undergo PBSC transplantation
12059298|NCT00119366|Drug|cyclosporine|Given IV or PO
12059299|NCT00119366|Drug|mycophenolate mofetil|Given PO
12059300|NCT00119366|Other|laboratory biomarker analysis|Correlative studies
12059301|NCT00119340|Drug|cyclosporine|
12059302|NCT00119340|Drug|fludarabine phosphate|
12059303|NCT00119340|Drug|mycophenolate mofetil|
12059304|NCT00119340|Procedure|peripheral blood stem cell transplantation|
12059305|NCT00119340|Radiation|radiation therapy|
12059306|NCT00119314|Drug|capecitabine|
12059307|NCT00119314|Drug|docetaxel|
12059308|NCT00119314|Drug|gemcitabine hydrochloride|
12059309|NCT00119314|Procedure|positron emission tomography|
12059310|NCT00119301|Drug|leucovorin calcium|
12059311|NCT00119301|Drug|methotrexate|
12059312|NCT00119301|Drug|trimetrexate glucuronate|
12059313|NCT00119262|Drug|doxorubicin hydrochloride|Given IV
12059314|NCT00119262|Drug|cyclophosphamide|Given IV
12059315|NCT00119262|Biological|bevacizumab|Given IV
12059321|NCT00119262|Drug|aromatase inhibition therapy|Receive aromatase inhibition therapy
12059322|NCT00119249|Drug|sorafenib tosylate|Given orally
12059323|NCT00119249|Other|laboratory biomarker analysis|Correlative studies
12059324|NCT00119236|Drug|tanespimycin|
12059325|NCT00119236|Drug|irinotecan hydrochloride|
12059326|NCT00119210|Drug|Bupropion SR|
12059327|NCT00119210|Other|placebo|
12059328|NCT00119197|Biological|killed whole cell oral cholera vaccine|"Bivalent oral killed cholera vaccine: each dose of this vaccine contains:
~Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells
~Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells
~Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells
~Inactivated V.Cholerae O139 - 50.109 cells
~each 1.5 mL dose given orally, two doses given 14 days apart"
12059329|NCT00119197|Biological|Heat Killed E. coli|"Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine.
~Each 1.5 mL dose given orally, two doses given 14 days apart"
12059330|NCT00119184|Procedure|External cephalic version|7.5 mg bupivacaine intrathecally
12059331|NCT00119184|Drug|spinal anesthesia|spinal anesthesia
12059332|NCT00119171|Drug|Ispinesib|
12059333|NCT00119171|Drug|Capecitabine|
12059334|NCT00119158|Drug|Combination of pimecrolimus and fluticasone|Pimecrolimus cream twice a day and fluticasone cream once a day
12059335|NCT00119158|Drug|pimecrolimus|apply daily with fluticasone cream for flares
12059336|NCT00119145|Drug|artesunate-amodiaquine|
12059337|NCT00119145|Drug|coartem|
12059338|NCT00119145|Drug|artesunate-lapdap|
12059339|NCT00119132|Drug|artesunate-amodiaquine|
12059340|NCT00119132|Drug|sulphadoxine-pyrimethamine|
12059341|NCT00119119|Drug|pentoxyphilline|
12059342|NCT00119119|Drug|tocopherol|
12059343|NCT00119106|Device|Tenofovir|
12059344|NCT00119093|Procedure|Laboratory and clinical monitoring regimens|
12059345|NCT00119080|Biological|meningococcal conjugate vaccine (Menactra)|
12059346|NCT00119067|Biological|BioThrax or Anthrax Vaccine Adsorbed|
12059347|NCT00119054|Behavioral|In Home Health Messaging Device|
12059348|NCT00119041|Behavioral|The Diabetes Treatment Satisfaction Questionnaire|A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
12059349|NCT00119041|Behavioral|Diabetes Empowerment Scale|A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
12059350|NCT00119041|Behavioral|CBOC's undergo half-day joint-clinics via teleconference|A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
12059351|NCT00119028|Procedure|Depression Care Quality Improvement Implementation|We will used a randomized design to evaluate long term (18-month) cost effectiveness of TIDES collaborative care in six intervention clinics with fully-implemented collaborative care compared to three matched and randomly-assigned usual care clinics. We used a non-randomized quasiexperimental design (untreated control group with pretest and posttest) to measure impacts on clinician performance, knowledge, and attitudes in 6 newly-implemented collaborative care intervention clinics compared to 6 matched usual care clinics
12059352|NCT00119015|Drug|Placebo|
12059353|NCT00119015|Drug|Montelukast|
12059354|NCT00119015|Drug|Fluticasone propionate|
12059355|NCT00119002|Drug|dexamethasone|1mg/kg dexamethasone
12059356|NCT00119002|Drug|Placebo|1mg/kg placebo
12059357|NCT00118989|Dietary Supplement|Curcuminoids|Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
12059358|NCT00118976|Drug|Lisinopril|
12059359|NCT00118963|Drug|Metformin|Tablets of 500 mg; 1000 mg two times daily.
12059360|NCT00118963|Drug|Insulin BIAsp30 (Novolog 70/30)|Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
12059361|NCT00118963|Drug|Repaglinide|Tablets of 1 mg; Dosage: 2 mg three times daily.
12059362|NCT00118963|Drug|Placebo-Metformin|Tablets corresponding to 500 mg; two tablets two times daily.
12059363|NCT00118963|Drug|Placebo-Repaglinide|Tablet corresponding to 1 mg; two tablets three times daily.
12059364|NCT00118950|Drug|Metformin|Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
12059365|NCT00118950|Drug|Repaglinide|Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
12059366|NCT00118950|Drug|Placebo-Metformin.|Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
12059367|NCT00118950|Drug|Placebo-Repaglinide.|Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
12059368|NCT00118950|Other|Diet-only.|Diet-only treatment. Duration: One month.
12059369|NCT00118937|Drug|Metformin|Tablet Metformin 500 mg, Dosage: 1000 mg two times daily (2000 mg total daily dose).
12059370|NCT00118937|Drug|Placebo.|Tablet Placebo (corresponding to 500 mg metformin). Dosage: 1 tablet per day.
12059371|NCT00118937|Drug|Placebo.|Tablet Placebo (corresponding to 500 mg metformin). Dosage: 2 tablets two times daily.
12059372|NCT00118924|Biological|LGT(TP21)/DEN4|Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)
12059373|NCT00118924|Biological|Placebo|Placebo for LGT(TP21)/DEN4 vaccine
12059374|NCT00118911|Behavioral|Cognitive behavioral therapy (CBT)|Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
12059375|NCT00118911|Other|Relaxation techniques and education about ADHD|Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.
12059376|NCT00118898|Drug|Abacavir/Lamivudine|600 mg abacavir/300 mg lamivudine tablet taken orally daily
12059377|NCT00118898|Drug|Atazanavir|300 mg tablet taken orally daily
12059378|NCT00118898|Drug|Efavirenz|600 mg tablet taken orally daily
12059379|NCT00118898|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily
12059380|NCT00118898|Drug|Ritonavir|100 mg tablet taken orally daily
12059381|NCT00118898|Drug|Abacavir/Lamivudine placebo|Placebo tablet taken orally daily
12059382|NCT00118898|Drug|Emtricitabine/Tenofovir disoproxil fumarate placebo|Placebo tablet taken orally daily
12059383|NCT00118885|Behavioral|Tai Chi Chih|
12059384|NCT00118872|Drug|LGG yogurt|Lactobacillus GG containing yogurt
12059385|NCT00118872|Other|Placebo yogurt|Yogurt NOT containing the active LGG bacteria
12059386|NCT00118859|Behavioral|Integrative care for low back pain|
12059387|NCT00118859|Behavioral|Conventional treatment for low back pain|
12059388|NCT00118846|Dietary Supplement|25 g soy protein supplement|25 g soy protein admisitered in equally divided dosage twice daily
12059389|NCT00118846|Other|Matching placebo|Milk protein administered twice daily
12059390|NCT00118833|Drug|Hypericum perforatum (St. John's wort)|
12059391|NCT00118820|Drug|IV Preoperative antibiotic or placebo|
12059392|NCT00118807|Drug|Amodiaquine plus artesunate (AQ/AS)|
12059393|NCT00118807|Drug|Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)|
12059394|NCT00118807|Drug|Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)|
12059395|NCT00118794|Drug|Chlorproguanil-dapsone (Lapdap)|
12059396|NCT00118794|Drug|Lumefantrine-artemether (Coartemether )|
12059397|NCT00118781|Drug|iseganan hydrochloride|
12059398|NCT00118768|Drug|valopicitabine|
12059399|NCT00118768|Drug|Pegylated Interferon Alfa|
12059400|NCT00118755|Drug|capecitabine|850 mg/m^2 po bid on Days 1-14 of each 3-week cycle
12059401|NCT00118755|Drug|Oxaliplatin|130 mg/m^2 IV on Day 1 of each 3-week cycle
12059402|NCT00118755|Drug|bevacizumab|7.5 mg/kg IV on Day 1 of each 3-week cycle
12059403|NCT00118755|Drug|capecitabine|1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle
12059404|NCT00118755|Drug|Oxaliplatin|85 mg/m^2 IV on Day 1 of each 2-week cycle
12059405|NCT00118755|Drug|bevacizumab|5 mg/kg IV on Day 1 of each 2-week cycle
12059406|NCT00118742|Drug|mycophenolate mofetil [CellCept]|1-1.5 g orally or intravenously twice daily
12059407|NCT00118742|Drug|Tacrolimus|As prescribed, for 12 months
12059408|NCT00118742|Drug|Cyclosporine|As prescribed, for 12 months
12059409|NCT00118742|Drug|Sirolimus|2-4 mg orally once daily for 9-11 months
12059410|NCT00118729|Drug|GW685698X Aqueous Nasal Spray|
12059411|NCT00118716|Drug|Fluticasone propionate/salmeterol|Fluticasone propionate/salmeterol
12059412|NCT00118716|Drug|Fluticasone Propionate|Fluticasone Propionate
12059413|NCT00118703|Drug|GW685698X|
12059414|NCT00118690|Drug|Fluticasone propionate/salmeterol|
12059415|NCT00118677|Procedure|Treatment interruption|
12059416|NCT00118638|Drug|Darbepoetin alfa - 2.25 mcg/kg|Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
12059417|NCT00118638|Drug|Darbepoetin alfa - 500mcg|Darbepoetin alfa 500mcg Q3W dosing / placebo QW
12059418|NCT00118625|Biological|Tree MATA MPL|
12059419|NCT00118612|Biological|Tree MATA MPL|
12059420|NCT00118573|Procedure|EVAR (Endovascular repair of Abdominal Aortic aneurysm)|AAA repair with endografting
12059421|NCT00118573|Procedure|Surveillance|Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow
12059422|NCT00118560|Behavioral|Physical exercise|treadmill walking
12059423|NCT00118560|Behavioral|Physical walking|calf muscle exercise
12059424|NCT00118547|Behavioral|In home monitoring with feedback|Behavioral counseling
12059425|NCT00118534|Behavioral|Integrated Care for Smoking Cessation in PTSD patients|Smoking cessation therapy is integrated with PTSD therapy.
12059426|NCT00118534|Behavioral|Standard of Care|Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.
12059427|NCT00118521|Procedure|Foot Orthotics|
12059428|NCT00118521|Procedure|Physiotherapy|
12059429|NCT00118508|Drug|risedronate (including placebo)|risedronate 35mg weekly
12059430|NCT00118495|Drug|Non-prescription Zestra(TM): patented formulation|
12059431|NCT00118482|Drug|fludrocortisone acetate|Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
12059432|NCT00118469|Behavioral|Psychoeducation|
12059433|NCT00118469|Behavioral|Cognitive behavior therapy|
12059434|NCT00118456|Drug|AEE788|
12059435|NCT00118443|Behavioral|Question, Persuade, Refer (QPR) training|
12059436|NCT00118430|Behavioral|Stepped Care|Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
12059437|NCT00118430|Drug|Antidepressants|Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg).
12059438|NCT00118430|Drug|Usual Care|This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
12059439|NCT00118417|Drug|Clonazepam|Participants will receive clonazepam.
12059440|NCT00118417|Drug|Sertraline|Participants will receive sertraline.
12059441|NCT00118417|Behavioral|Cognitive behavioral therapy|Participants will receive cognitive behavioral therapy
12059442|NCT00118404|Behavioral|Continuation phase cognitive therapy|Continuation phase cognitive therapy included 10 sessions over 8 months.
12059443|NCT00118404|Drug|Continuation phase fluoxetine|The dosage of fluoxetine was increased to 40 mg over 8 months.
12059444|NCT00118404|Other|Continuation phase pill placebo|The dosage of pill placebo was increased to 40 mg over 8 months.
12059445|NCT00118404|Behavioral|Acute phase cognitive therapy|For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
12059446|NCT00118391|Behavioral|Cognitive behavior therapy|Receive 8 50-minute sessions of one-on-one cognitive behavioral therapy
12059447|NCT00118391|Behavioral|Contingency management|Receive vouchers that can be spent on rewards for completing activities that support abstinence from gambling
12059448|NCT00118378|Drug|Modafinil|50 mg per day, increasing to 200 mg per day as clinically indicated
12059449|NCT00118378|Drug|Placebo|50 mg per day, increasing to 200 mg per day as clinically indicated
12059450|NCT00118365|Other|placebo|Given orally
12059451|NCT00118365|Drug|eflornithine|Given orally
12059452|NCT00118365|Drug|sulindac|Given orally
12059453|NCT00118365|Other|laboratory biomarker analysis|Correlative studies
12059454|NCT00118352|Biological|alemtuzumab|Given IV
12059455|NCT00118352|Radiation|total-body irradiation|Undergo low-dose TBI
12059456|NCT00118352|Drug|fludarabine phosphate|Given IV
12059457|NCT00118352|Drug|cyclosporine|Given PO or IV
12059458|NCT00118352|Drug|mycophenolate mofetil|Given PO
12059459|NCT00118352|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic stem cell transplantation
12059460|NCT00118352|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
12059461|NCT00118352|Biological|graft versus host disease prophylaxis/therapy|Undergo GVHD prophylaxis/therapy
12059462|NCT00118352|Other|laboratory biomarker analysis|Correlative studies
12059463|NCT00118339|Drug|chemoprotection|
12059464|NCT00118339|Procedure|complementary or alternative medicine procedure|
12059465|NCT00118339|Procedure|management of therapy complications|
12059466|NCT00118326|Biological|filgrastim|
12059467|NCT00118326|Procedure|allogeneic bone marrow transplantation|
12059468|NCT00118313|Biological|incomplete Freund's adjuvant|
12059469|NCT00118313|Biological|multi-epitope melanoma peptide vaccine|
12059470|NCT00118313|Biological|sargramostim|
12059471|NCT00118313|Biological|tetanus toxoid helper peptide|
12059472|NCT00118313|Drug|dimethyl sulfoxide|
12059473|NCT00118313|Drug|imiquimod|
12059474|NCT00118313|Procedure|adjuvant therapy|
12059475|NCT00118300|Drug|capecitabine|Patients also receive oral capecitabine twice daily 7 days a week in weeks 1-5 and 7-8. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
12059476|NCT00118300|Radiation|brachytherapy|1 or 2 applications of low-dose rate intracavitary brachytherapy in weeks 7-8 OR 5 applications of high-dose rate (HDR)* intracavitary brachytherapy once weekly in weeks 4-8.
12059477|NCT00118300|Radiation|radiation therapy|Patients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in weeks 1-5.
12059478|NCT00118287|Drug|azacitidine|Given SC or IV
12059479|NCT00118287|Biological|etanercept|Given SC
12059480|NCT00118274|Biological|incomplete Freund's adjuvant|Given intradermally and subcutaneously
12059481|NCT00118274|Biological|melanoma helper peptide vaccine|Given intradermally and subcutaneously
12059482|NCT00118274|Biological|multi-epitope melanoma peptide vaccine|Given intradermally and subcutaneously
12059483|NCT00118274|Biological|tetanus toxoid helper peptide|Given intradermally and subcutaneously
12059484|NCT00118274|Drug|cyclophosphamide|Given IV
12059485|NCT00118261|Biological|bevacizumab|Beginning in course 3, patients also receive bevacizumab IV over 30 minutes. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
12059486|NCT00118261|Drug|erlotinib hydrochloride|Courses 1-3: oral erlotinib once daily on days 1-14. Patients who do not develop grade 2 toxicity after the first 3 courses (6 weeks) will have their erlotinib dose escalated. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
12059487|NCT00118261|Drug|fluorouracil|Starting with course 2: fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
12059488|NCT00118261|Drug|leucovorin calcium|Starting with course 2: Leucovorin calcium IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
12059489|NCT00118261|Drug|oxaliplatin|Starting with course 2: oxaliplatin IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
12059490|NCT00118248|Drug|tanespimycin|Given IV
12059491|NCT00118235|Drug|cisplatin|Given IV
12059492|NCT00118235|Drug|irinotecan hydrochloride|Given IV
12059493|NCT00118235|Biological|bevacizumab|Given IV
12059494|NCT00118235|Other|laboratory biomarker analysis|Correlative studies
12059495|NCT00118222|Drug|porfimer sodium|All patients receive porfimer sodium IV.
12059496|NCT00118222|Procedure|adjuvant therapy|All patients receive porfimer sodium IV.
12059497|NCT00118222|Procedure|conventional surgery|All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
12059498|NCT00118209|Biological|rituximab|IV
12059499|NCT00118209|Drug|cyclophosphamide|IV
12059500|NCT00118209|Drug|doxorubicin|IV or CIVI
12059501|NCT00118209|Drug|vincristine|IV or CIVI
12059502|NCT00118209|Drug|prednisone|oral
12059503|NCT00118209|Drug|etoposide|CIVI
12059504|NCT00118209|Drug|filgrastim|IV
12059505|NCT00118209|Drug|pegfilgrastim|IV
12059506|NCT00118196|Drug|arsenic trioxide|
12059507|NCT00118196|Drug|azacitidine|
12059508|NCT00118183|Drug|docetaxel|Given IV
12059509|NCT00118183|Biological|cetuximab|Given IV
12059510|NCT00118183|Drug|bortezomib|Given IV
12059511|NCT00118170|Drug|sorafenib tosylate|Given orally
12059512|NCT00118170|Other|pharmacological study|Correlative studies
12059513|NCT00118157|Other|Laboratory Biomarker Analysis|Correlative studies
12059514|NCT00118157|Drug|Lapatinib Ditosylate|Given PO
12059515|NCT00118157|Drug|Tamoxifen Citrate|Given PO
12059516|NCT00118144|Drug|bortezomib|Given IV
12059517|NCT00118131|Drug|cisplatin|
12059518|NCT00118131|Drug|docetaxel|
12059519|NCT00118105|Biological|bevacizumab|Preoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Postoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
12059520|NCT00118105|Drug|capecitabine|Pre & Post Operative: 1,700 mg/m^2/day, PO at 12 hr interval, Days 1-14 of cycles 1,2,3,4
12059521|NCT00118105|Drug|oxaliplatin|130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
12059522|NCT00118105|Procedure|conventional surgery|Resection
12059523|NCT00118092|Drug|tanespimycin|Given IV
12059524|NCT00118092|Other|laboratory biomarker analysis|Correlative studies
12059525|NCT00118066|Dietary Supplement|calcitriol|Given orally
12059526|NCT00118066|Procedure|observation|No initial intervention
12059527|NCT00118053|Biological|herceptin|
12059528|NCT00118053|Drug|carboplatin|
12059529|NCT00118053|Drug|docetaxel|
12059530|NCT00118053|Procedure|conventional surgery|Modified radical mastectomy or lumpectomy and axillary node dissection
12059531|NCT00118053|Procedure|radiation therapy|Whole breast or chest wall irradiation (as determined by radiologist)
12059532|NCT00118040|Drug|Genistein|Given orally
12059533|NCT00118040|Other|Laboratory Biomarker Analysis|Correlative studies
12059534|NCT00118040|Other|Pharmacological Study|Correlative studies
12059535|NCT00118040|Other|Placebo Administration|Given orally
12059536|NCT00118040|Procedure|Therapeutic Conventional Surgery|Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
12059537|NCT00118027|Drug|sulphadoxine-pyrimethamine intermittent preventive treatment|
12059538|NCT00118014|Drug|Sertraline|
12059539|NCT00118014|Behavioral|Habit Reversal Training|
12059540|NCT00118001|Behavioral|Worry exposure|
12059541|NCT00118001|Behavioral|Applied relaxation|
12059542|NCT00117988|Drug|tanespimycin|
12059543|NCT00117975|Biological|galiximab|given IV
12059544|NCT00117975|Biological|rituximab|Given IV
12059545|NCT00117962|Biological|cetuximab|400 mg/sq m IV over 120 min: Day 1; Week 1 250 mg/sq m IV over 60 min weekly for 6 more weeks.
12059546|NCT00117962|Drug|carboplatin|AUC = 5 q 21 days for 4 cycles
12059547|NCT00117962|Drug|pemetrexed disodium|500 mg/sq m IV q 21 days during chemoradiation and consolidation chemotherapy phases
12059548|NCT00117962|Radiation|radiation therapy|Thoracic radiotherapy: 70 Gy for 7 weeks beginning on Day 1.
12059549|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
12059550|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
12059551|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
12059552|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
12059553|NCT00117936|Combination Product|Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose|Up to ten intramyocardial injections of low dose FGF 1-141, via a NOGA Injection Catheter, single cath lab session
12059554|NCT00117936|Combination Product|Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose|Up to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session
12059555|NCT00117936|Combination Product|Placebo|Up to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session
12059556|NCT00117923|Drug|Resiquimod|
12059557|NCT00117910|Drug|pegfilgrastim|
12059558|NCT00117897|Drug|pegfilgrastim|
12059559|NCT00117897|Drug|Filgrastim|
12059560|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059561|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059562|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059563|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059564|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059565|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059566|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059567|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059568|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059569|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059570|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
12059571|NCT00117871|Drug|Resiquimod|
12059572|NCT00117858|Procedure|Anodal DC polarization of left prefrontal cortex|
12059573|NCT00117845|Biological|Denileukin diftitox (Ontak)|Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
12059574|NCT00117832|Drug|Azelastine nasal spray|
12059575|NCT00117819|Drug|[123I]ß CIT and SPECT imaging|To assess [123I]ß CIT and SPECT imaging
12059576|NCT00117806|Behavioral|Arm 1|SCI-VIP: Supported employment implemented for veterans with spinal cord injury.
12059577|NCT00117806|Behavioral|Arm 2|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
12059578|NCT00117793|Device|Total Surface Bearing Suction Socket|Current clinical practice
12059579|NCT00117793|Device|Vacuum assisted socket system|Novel socket system
12059580|NCT00117780|Drug|insulin detemir|
12059581|NCT00117780|Drug|insulin aspart|
12059582|NCT00117767|Drug|Terbinafine hydrochloride (HCl)|Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
12059583|NCT00117767|Drug|Griseofulvin|Griseofulvin pediatric suspension o.d. administration
12059584|NCT00117754|Drug|Terbinafine hydrochloride|
12059585|NCT00117741|Behavioral|Dialectical Behavior Therapy|Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone
12059586|NCT00117741|Behavioral|Drug Counseling|Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,
12059587|NCT00117728|Drug|nevirapine|
12059644|NCT00117390|Procedure|Measurement of inulin clearance|
12059588|NCT00117715|Procedure|Genotyping and Phenotyping using dextromethorphan and caffeine as probes|Single doses of dextromethorphan (0.3 mg/kg)and caffeine (3.0 mg/kg) are administered and urine is collected overnight for measurement of drug and metabolites to determine drug biotransformation activity.
12059589|NCT00117702|Drug|Tacrolimus|day 0-100, then taper
12059590|NCT00117702|Drug|Everolimus|day 0-56
12059591|NCT00117689|Biological|Thymoglobulin|Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
12059592|NCT00117689|Drug|Corticosteroid|For a minimum of 3 months
12059593|NCT00117689|Drug|Tacrolimus|Between Day 3 the last dose of Thymoglobulin
12059594|NCT00117689|Drug|Mycophenolate Mofetil|for at least 1 month posttransplant
12059595|NCT00117676|Drug|TDF|300 mg tablet administered orally once daily
12059596|NCT00117676|Drug|ADV|10 mg tablet administered orally once daily
12059597|NCT00117676|Drug|TDF placebo|Tablet administered orally once daily
12059598|NCT00117676|Drug|ADV placebo|Tablet administered orally once daily
12059599|NCT00117676|Drug|FTC/TDF|200/300 mg fixed-dose combination (FDC) tablet administered orally once daily
12059600|NCT00117663|Drug|Cessation of Hormone Replacement Therapy|
12059601|NCT00117650|Biological|Ad2/HIF-1α/VP16|a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections
12059602|NCT00117650|Biological|Ad2/HIF-1α/VP16|one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
12059603|NCT00117650|Biological|Ad2/HIF-1α/VP16|a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
12059604|NCT00117650|Other|Saline (Placebo Control)|a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
12059605|NCT00117637|Drug|Sorafenib (Nexavar, BAY43-9006)|Multi kinase inhibitor
12059606|NCT00117637|Drug|Interferon|Interferon
12059607|NCT00117624|Drug|darbepoetin alfa|
12059608|NCT00117611|Drug|Anti-IgE antibody omalizumab or placebo|given subcutaneously oce or twice monthly depending on dose
12059609|NCT00117598|Drug|Temsirolimus (CCI-779)|Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
12059610|NCT00117598|Drug|Temsirolimus (CCI-779)|Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
12059611|NCT00117598|Drug|Investigator's choice|"Any of the following single agent treatments:
~Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
~Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days
~Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days
~Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days
~Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
~Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
~Prednisone 40 (20-60) mg/m2 PO daily or every other day
~Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day"
12059612|NCT00117585|Other|Treatment Phase 1|"Patient Education
~Physical Therapy Exercises
~Increased Salt Intake
~Elevation of head of bed with 2-4 inch wedge
~Medication Review by MD, Pharma"
12059613|NCT00117585|Drug|Treatment Phase 2|"Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.
~Fludrocortisone
~Salt tablet"
12059614|NCT00117585|Other|Treatment Phase 3|Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.
12059615|NCT00117572|Drug|docetaxel|75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
12059616|NCT00117572|Drug|cisplatin|75 mg/m2 on day 1
12059617|NCT00117572|Drug|hydroxyurea|Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
12059618|NCT00117572|Drug|fluorouracil|750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
12059619|NCT00117572|Procedure|chemotherapy|See protocol for details
12059620|NCT00117572|Procedure|radiotherapy|See protocol for details
12059621|NCT00117559|Behavioral|Telehealth Treatment|Participants receive a 15-minute telephone call for 8 weeks
12059622|NCT00117546|Drug|alpha methyldopa|500 mg twice a day
12059623|NCT00117533|Drug|pegylated IFN alfa-2b plus ribavirin|
12059624|NCT00117520|Drug|Caffeine|
12059625|NCT00117507|Drug|deferasirox|deferasirox 20 mg/kg/day taken over one year.Deferasirox should be taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets should be dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
12059626|NCT00117494|Drug|Pravastatin|
12059627|NCT00117494|Drug|Rosuvastatin|
12059628|NCT00117481|Drug|DR-2001a|DR-2001a administered vaginally each month
12059629|NCT00117481|Drug|DR-2001b|DR-2001b administered vaginally each month
12059630|NCT00117481|Other|Placebo|Placebo administered vaginally each month
12059631|NCT00117468|Drug|DR-2011|Administered vaginally from Day 14 to Day 31
12059632|NCT00117468|Drug|Progesterone 8% Vaginal Gel|Administered vaginally from Cycle Day 14 to Day 31
12059633|NCT00117455|Drug|pegfilgrastim|
12059634|NCT00117455|Drug|filgrastim|
12059635|NCT00117442|Drug|carboplatin|Chemotherapy
12059636|NCT00117442|Drug|paclitaxel|chemotherapy
12059637|NCT00117442|Drug|pegfilgrastim|Growth factor for mobilization
12059638|NCT00117429|Biological|HIV gp120/NefTat/AS02A Vaccine|im injection, 0.6-0.7 ml
12059639|NCT00117416|Procedure|controlling the MAP|
12059640|NCT00117403|Drug|Vitamin E, Vitamin C, and Alpha-lipoic Acid|vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals
12059641|NCT00117403|Drug|Coenzyme Q|400 mg, compounded as a wafer, two wafers three times per day with meals
12059642|NCT00117403|Drug|Placebo capsules|one placebo capsule three times per day with meals
12059643|NCT00117403|Drug|Placebo wafers|two placebo wafers three times per day with meals
12059645|NCT00117377|Drug|Pimecrolimus|Pimecrolimus cream 1 % bid
12059646|NCT00117377|Drug|Placebo|Placebo application bid
12059647|NCT00117364|Drug|SACCHACHITIN patch|
12059648|NCT00117351|Drug|VELCADE|
12059649|NCT00117338|Drug|montelukast sodium|Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration
12059650|NCT00117338|Drug|Comparator: placebo (unspecified)|Pbo for a study approximately 120 minutes in duration
12059651|NCT00117325|Drug|GW685698X|Aqueous Nasal Spray 100mcg
12059652|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
12059653|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
12059654|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
12059655|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
12059656|NCT00117299|Drug|PTK787/ZK222584|PTK787/ZK222584 is administered at the dosage of 1250 mg o.d. orally
12059657|NCT00117286|Drug|Degarelix|Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
12059658|NCT00117273|Drug|Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]|1 tablet daily
12059659|NCT00117273|Drug|Seasonique (LNG/EE and EE)|1 tablet daily
12059660|NCT00117273|Drug|Portia (LNG/EE)|1 tablet daily x 28 days
12059661|NCT00117260|Drug|Seasonale (levonorgestrel and ethinyl estradiol)|
12059662|NCT00117247|Drug|darbepoetin alfa|
12059663|NCT00117234|Drug|darbepoetin alfa|
12059664|NCT00117208|Drug|mannitol|400mg BD for 12 weeks
12059665|NCT00117208|Drug|mannitol + pulmozyme|combination
12059666|NCT00117208|Drug|Dornase alpha|2.5mg daily for 2 weeks
12059667|NCT00117195|Device|Automated Neuropsychological Assessment Matrix|"This study will evaluate a profile of neurophysiologic tests for potentially predictive signs of PD or PS in individuals with PD or PS, those who may be at risk for PD or PS and in a population of individuals without parkinsonian symptoms or any other neurologic conditions.
~In addition, the study will evaluate serum samples for changes in proteins or metabolites that may be indicators of early changes associated with Parkinson's disease or parkinsonian syndrome."
12059668|NCT00117182|Drug|Dry powder mannitol|
12059669|NCT00117182|Drug|Budesonide 400mcg administered via turbuhaler|
12059670|NCT00117182|Drug|Ipratropium bromide 80mcg|
12059671|NCT00117182|Drug|Salbutamol 400mcg|
12059672|NCT00117169|Procedure|multi-detector helical computed tomography|
12059673|NCT00117156|Drug|Fludarabine|
12059674|NCT00117156|Drug|Rituximab|
12059675|NCT00117143|Drug|Romiplostim|Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.
12059676|NCT00117130|Drug|Aranesp®|
12059677|NCT00117117|Drug|Aranesp|
12059678|NCT00117104|Drug|Aranesp®|
12059679|NCT00117091|Drug|Anakinra (Kineret®)|
12059680|NCT00117078|Drug|Aranesp®|
12059681|NCT00117065|Drug|Aranesp®|
12059682|NCT00117052|Drug|cinacalcet|All eligible subjects were assigned to receive once daily oral doses of cinacalcet, but were randomised in a 1:1 ratio to receive the drug either with the first meal after dialysis or during the dialysis visit on dialysis days.
12059683|NCT00117039|Drug|Aranesp®|
12059684|NCT00117026|Drug|Placebo|Placebo for benfotiamine
12059685|NCT00117026|Drug|Benfotiamine|300mg/day
12059686|NCT00117013|Drug|Fluorine-19-Fluoroded Xyglucose|
12059687|NCT00117013|Drug|Topotecan|
12059688|NCT00117000|Drug|testosterone undecanoate|
12059689|NCT00116987|Device|Dual chamber cardiac pacemaker|Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.
12059690|NCT00116987|Device|Single chamber cardiac pacemaker|Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.
12059691|NCT00116974|Procedure|Scaling and root planing|Scaling and root planing
12059692|NCT00116961|Drug|Velcade|
12059693|NCT00116961|Drug|Doxil|
12059694|NCT00116961|Drug|Dexamethasone|
12059695|NCT00116948|Device|ReCap, Hip resurfacing system, Biomet|ReCap total hip arthroplasty inserted according to manufactures manual.
12059696|NCT00116935|Drug|imatinib mesylate|imatinib 400 mg/day orally qd for 12 months
12059697|NCT00116935|Drug|imatinib|imatinib 400 mg/d orally qd for 36 months
12059698|NCT00116935|Drug|imatinib|imatinib 400 mg/d orally qd for 36 months
12059699|NCT00116922|Drug|Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID|[Rosiglitazone 2mg/ Metformin 500mg] twice daily
12059700|NCT00116909|Drug|OSI 7904L|
12059701|NCT00116896|Drug|OSI-7904L|
12059702|NCT00116896|Drug|Cisplatin|
12059703|NCT00116883|Drug|GW685698X aqueous nasal spray|
12059704|NCT00116870|Drug|lovastatin|
12059705|NCT00116857|Drug|Sertraline/omega-3|Sertraline (50 mgs) plus omega-3 (2 grams)
12059706|NCT00116857|Drug|Sertraline/Corn Oil|Sertraline (50 mgs) plus corn oil (2 grams) (placebo)
12059707|NCT00116844|Drug|Valaciclovir|Valtrex 1g once daily
12059708|NCT00116844|Drug|Placebo|placebo
12059709|NCT00116831|Drug|Glipizide|oral anti-diabetic medication
12059710|NCT00116831|Drug|rosiglitazone maleate|oral antidiabetic medication
12059711|NCT00116818|Drug|GW685698X aqueous nasal spray|
12059712|NCT00116805|Drug|TDF|300 mg tablet administered orally once daily
12059713|NCT00116805|Drug|ADV|10 mg tablet administered orally once daily
12059714|NCT00116805|Drug|TDF placebo|Tablet administered orally once daily
12059715|NCT00116805|Drug|ADV placebo|Tablet administered orally once daily
12059716|NCT00116805|Drug|FTC/TDF|200/300 mg fixed-dose combination (FDC) tablet administered orally once daily
12059717|NCT00116792|Procedure|Percutaneous Coronary Intervention (PCI)|
12059962|NCT00114725|Procedure|Laser-assisted intracytoplasmic sperm injection|
12059718|NCT00116779|Drug|Degarelix|Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.
12059719|NCT00116766|Device|anti-mosquito plant use|
12059720|NCT00116753|Drug|Degarelix|Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9
12059721|NCT00116753|Drug|Degarelix|Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9
12059722|NCT00116753|Drug|Degarelix|Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10
12059723|NCT00116740|Drug|APD356|
12059724|NCT00116727|Drug|ENBREL®|50 mg/wk SC
12059725|NCT00116714|Drug|DMARD|All subjects were required to initiate, add or change DMARD therapy at study entry.
12059726|NCT00116701|Drug|Aranesp®|
12059727|NCT00116688|Biological|Romiplostim|Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
12059728|NCT00116675|Drug|Resiquimod|
12059729|NCT00116662|Drug|Resiquimod|
12059730|NCT00116649|Drug|imiquimod cream|imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles
12059731|NCT00116636|Drug|Kaletra|
12059732|NCT00116623|Drug|Indomethacin|
12059733|NCT00116623|Drug|Magnesium sulfate|
12059734|NCT00116610|Drug|picoplatin|
12059735|NCT00116597|Genetic|Intranodal immunization with a recombinant vaccinia virus expressing 5 transgenes|
12059736|NCT00116597|Biological|Intranodal booster immunizations with synthetic melanoma associated epitopes|
12059737|NCT00116584|Drug|heliox|continuous heliox therapy
12059738|NCT00116584|Drug|oxygen|continuous oxygen therapy
12059739|NCT00116571|Drug|Lemuteporfin for injection|
12059740|NCT00116571|Device|Transurethral drug delivery system|
12059741|NCT00116571|Device|Transurethral light delivery system|
12059742|NCT00116558|Device|Early NIPPV|Early intervention with non-invasive positive pressure ventilation (NIPPV) at 80% forced vital capacity (FVC).
12059743|NCT00116558|Device|Standard NIPPV|Standard of care non-invasive positive pressure ventilation (NIPPV) at 50% forced vital capacity (FVC).
12059744|NCT00116545|Drug|troglitazone|
12059745|NCT00116532|Drug|Escitalopram|
12059746|NCT00116519|Drug|PPAR alpha|
12059747|NCT00116519|Drug|placebo|
12059748|NCT00116506|Drug|erlotinib|
12059749|NCT00116506|Drug|FOLFOX|
12059750|NCT00116506|Drug|bevacizumab|
12059751|NCT00116493|Dietary Supplement|Iron-folic acid and mebendazole|"100 mg iron for pregnant women, 25 mg iron for children
~1 mg of folic acid for pregnant women, 100 ug folic acid for children 500 mg of mebendazole for both pregnant women and children"
12059752|NCT00116493|Drug|Mebendazole|100 mg twice a day for 3 days; Iron-folic acid also given
12059753|NCT00116493|Dietary Supplement|Multivitamins|Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
12059754|NCT00116493|Drug|Mebendazole + Multivitamin|Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given
12059755|NCT00116480|Drug|Misoprostol|600 mcg of sublingual misoprostol
12059756|NCT00116467|Biological|GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)|
12059757|NCT00116454|Drug|131 I-lipiodol|intra-arterial hepatic administration of Lipiocis will occur, 11 to 12 weeks after the initial curative treatment
12059758|NCT00116441|Biological|Therapeutic Cellular Vaccine, GM-CSF Producing|
12059759|NCT00116428|Device|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
12059760|NCT00116428|Drug|Antiarrhythmic drug|Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.
12059761|NCT00116415|Drug|efavirenz; didanosine EC; lamivudine|
12059762|NCT00116402|Drug|fluticasone and salmeterol|"will start with fluticasone 220 mcg BID first and then crossover to combination therapy with salmeterol 50 mcg BID
~will start with salmeterol 50 mcg BID first and then crossover to combination therapy with fluticasone 220 mcg BID."
12059763|NCT00116389|Drug|talabostat mesylate tablets|
12059764|NCT00116389|Drug|gemcitabine|
12059765|NCT00116376|Drug|AEE788|
12059766|NCT00116363|Genetic|investigational drug INGN 241|
12059767|NCT00116350|Drug|Misoprostol|800 mcg sublingual misoprostol
12059768|NCT00116350|Drug|Oxytocin|40 IU Oxytocin IV
12059769|NCT00116337|Procedure|Spinal Cord Stimulation to restore cough|Participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are then activated at subsequent study visits using the external control unit.
12059770|NCT00116337|Device|Expiratory Muscle Stimulator|The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
12059771|NCT00116324|Drug|Montelukast|
12059772|NCT00116311|Behavioral|allergen inhalation|
12059773|NCT00116311|Behavioral|withdrawal of medication|
12059774|NCT00116311|Procedure|sputum induction|
12059775|NCT00116298|Drug|stavudine, efavirenz, lamivudine|
12059776|NCT00116285|Biological|Ragweed MATA MPL|
12059777|NCT00116272|Drug|Etanercept|Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study.
12059778|NCT00116259|Drug|Aripiprazole|
12059779|NCT00116246|Procedure|McRobert's manoeuvre|
12059780|NCT00116233|Device|REPEL-CV|
12059781|NCT00116220|Drug|Flutamide (Eulexin) and Lupron or Zoladex|Androgen suppression therapy
12059782|NCT00116220|Radiation|External Beam Radiotherapy|Once a day, 4-5 days per week for approximately 2 months
12059783|NCT00116207|Drug|ORAL ANTIOXIDANT|Comparison of triple antioxidant combination therapy vs placebo.
12059784|NCT00116194|Behavioral|Physical Activity|
12059785|NCT00116181|Drug|Etanercept|"All subjects will administer etanercept 50 mg twice weekly subcutaneously (2 injections of 25 mg etanercept SC within 1 hour twice weekly) for the first 12 weeks of study.
~Subjects randomized to the continuous therapy arm will then receive 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) for weeks 13 through 24. Subjects randomized to the intermittent therapy arm will be assessed for response. Those who achieve a responder status on the PGA (PGA score £ 2 and improved from baseline) at week 12 will discontinue therapy. Upon relapse of PGA responder status, etanercept will be administered 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) through week 24."
12059786|NCT00116168|Biological|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
12059787|NCT00116168|Biological|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
12059788|NCT00116168|Biological|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
12059789|NCT00116168|Biological|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
12059790|NCT00116155|Biological|CV787 (CG7870)|
12059791|NCT00116142|Drug|Docetaxel|60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.
12059792|NCT00116142|Drug|Androgen Hormonal Suppression and Radiation|Total Androgen Ablation and external beam radiation therapy
12059793|NCT00116142|Drug|Androgen Suppression Therapy and Radiation Therapy|Total Androgen Ablation and External Beam Radiation Therapy
12059794|NCT00116129|Drug|Ibutamoren Mesylate (MK-0677)|Ibutamoren Mesylate 25 mg/day
12059795|NCT00116116|Drug|efavirenz, stavudine extended release, lamivudine|
12059796|NCT00116103|Drug|Tacrolimus Inhalation Aerosol|
12059797|NCT00116064|Drug|intranasal lorazepam|
12059798|NCT00116064|Drug|intramuscular paraldehyde|
12059799|NCT00116051|Device|Acetabular implant, Monoblock cup|
12059800|NCT00116038|Device|Femoral implant (Versys Fiber Metal Taper®)|
12059801|NCT00116025|Drug|Human acylated ghrelin|
12059802|NCT00116012|Drug|rNAPc2|
12059803|NCT00115999|Drug|alfimeprase|
12059804|NCT00115986|Biological|Influenza A/H5N1 Vaccine|
12059805|NCT00115973|Device|pump|
12059806|NCT00115973|Drug|insulin aspart|
12059807|NCT00115960|Biological|HIV-1 gag DNA|DNA vaccine containing the HIV gene gag
12059808|NCT00115960|Biological|IL-15 DNA adjuvant|Cytokine injection
12059809|NCT00115960|Biological|IL-12 DNA adjuvant|Cytokine injection
12059810|NCT00115947|Drug|Terlipressin|
12059811|NCT00115934|Procedure|Blalock-Taussig pulmonary artery shunt|Performed at stage I palliative surgery for babies born with HLHS
12059812|NCT00115934|Procedure|Right ventricular to pulmonary artery shunt|Performed at stage I palliative surgery for babies born with HLHS
12059813|NCT00115921|Behavioral|Provision of antimalarial treatment at home|
12059814|NCT00115908|Drug|Albuferon|
12059815|NCT00115908|Drug|Ribavirin|
12059816|NCT00115908|Drug|PEG-IFNalfa2a|
12059817|NCT00115895|Drug|Radioactive iodine|Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
12059818|NCT00115882|Behavioral|MI + CBST|The HS Study intervention consisted of proactive identification and recruitment of eligible smokers (and selected nonsmokers) within the target population, and a protocol-guided series of counselor-initiated, personally-tailored telephone calls (from 1 to 10, depending on participant's interest) to eligible high school senior smokers and nonsmokers in experimental high schools. The telephone-delivered behavioral intervention integrated Motivational Interviewing and Cognitive Behavioral Skills building. Content and dose were tailored to the individual.
12059819|NCT00115869|Behavioral|Social-influences|grades 3-10, school-based social influences tobacco use prevention curriculum
12059820|NCT00115856|Procedure|Intravascular MRI|Arterial imaging of atherosclerosis
12059821|NCT00115843|Device|Mobile Cardiac Outpatient Telemetry|
12059822|NCT00115830|Drug|Atorvastatin|
12059823|NCT00115830|Drug|Rosuvastatin|
12059824|NCT00115817|Drug|Atorvastatin|
12059825|NCT00115804|Drug|Fluoxetine|Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily
12059826|NCT00115791|Drug|RSD1235|IV
12059827|NCT00115791|Drug|placebo|IV
12059828|NCT00115778|Drug|IVIG|10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
12059829|NCT00115778|Other|Placebo|0.1% Albumin in an equal volume to the investigational product
12059830|NCT00115765|Drug|Oxaliplatin Based Chemotherapy|Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
12059831|NCT00115765|Drug|Panitumumab|PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.
12059832|NCT00115765|Drug|Irinotecan Based Chemotherapy|Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
12059833|NCT00115765|Drug|Bevacizumab|Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
12059834|NCT00115752|Drug|Valdecoxib|
12059835|NCT00115752|Drug|COX Inhibitor|
12059836|NCT00115739|Drug|Imatinib|Imatinib 400 mg capsules were administered twice daily with food for 4 week cycles.
12059837|NCT00115726|Drug|furosemide|for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)
12059838|NCT00115726|Drug|placebo|patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.
12059839|NCT00115713|Behavioral|Aerobic Exercise Training|
12059840|NCT00115713|Behavioral|Resistance Exercise Training|
12059841|NCT00115700|Drug|Cyclophosphamide|1000 mg/m2 I.V. on day 1
12059842|NCT00115700|Radiation|Radiotherapy|The prescribed dose to the target volume will be 30 Gy. Daily fractions of 1.5-2.0 Gy will be employed.
12059843|NCT00115700|Drug|Vincristine|1.4 mg/m2 (maximum single dose of 2 mg) I.V. on day 1
12059844|NCT00115700|Drug|Prednisolone|50 mg/m2 orally daily for days 1 - 5
12059845|NCT00115700|Drug|Rituximab|375 mg/m2 IV Infusion day 1
12059846|NCT00115687|Drug|placebo|
12059847|NCT00115687|Drug|2 mg nicotine polacrilex|
12059848|NCT00115661|Drug|Rosiglitazone|
12059849|NCT00115648|Drug|Nevirapine|Oral NVP daily dosage
12059850|NCT00115648|Drug|AZT|Oral AZT daily
12059851|NCT00115648|Drug|NVP and AZT|Oral single dose NVP plus oral daily AZT during the first weeks
12059852|NCT00115648|Drug|NVP|Oral NVP daily to age 14 weeks
12059853|NCT00115648|Drug|NVP+AZT|Oral NVP daily plus oral AZT daly to age 14 weeks
12059854|NCT00115635|Drug|docetaxel|
12059855|NCT00115635|Drug|gemcitabine|
12059856|NCT00115622|Drug|fluticasone furoate|
12059857|NCT00115609|Drug|efavirenz|800mg for patients treated by rifampicine 600mg for other patients
12059858|NCT00115609|Drug|tenofovir DF|300mg once a day
12059859|NCT00115609|Drug|emtricitabine|one pill of 200mg once a day
12059860|NCT00115596|Other|Formal Curriculum; Low-Fidelity Simulation|The intervention was a formal procedural skills training curriculum consisting of didactic lectures and simulation training.
12059861|NCT00115583|Drug|Drug Infusion (BQ-123)|
12059862|NCT00115570|Drug|Insulin glulisine|Subcutaneous injection
12059863|NCT00115570|Drug|insulin lispro|Subcutaneous injection
12059864|NCT00115570|Drug|insulin glargine|Subcutaneous injection once daily
12059865|NCT00115570|Drug|NPH insulin|subcutaneous injection twice daily
12059866|NCT00115557|Other|Practice intervention|Performance feedback, academic detailing, practice facilitation, IT support
12059867|NCT00115557|Other|Practice intervention 2|Performance feedback only.
12059868|NCT00115544|Drug|Stanate|Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
12059869|NCT00115531|Biological|Trivalent inactivated influenza vaccine|Standard Dose Influenza Vaccine Fluzone® (15 µg HA / viral strain; 45 µg/0.5 mL dose) will be administered to Arm 1: 200 subjects intramuscularly on day 0.
12059870|NCT00115531|Biological|Trivalent inactivated influenza vaccine|High Dose Influenza Fluzone® Vaccine (60 µg HA / viral strain; 180 µg/0.5 mL dose) will be administered to Arm 2: 200 subjects intramuscularly on Day 0.
12059871|NCT00115518|Drug|cetuximab|After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance
12059872|NCT00115505|Other|quality-of-life assessment|Complete Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and EQ-5D and QOL Assessment Form, EORTC QLQ-C30 and EORTC QLQ-BR23
12059873|NCT00115505|Other|Questionnaire Administration|Complete the Employment and Informal Care Cost Assessment and Peripheral Neuropathy Assessments
12059874|NCT00115492|Drug|Fluticasone Propionate/Salmeterol Combination Product|
12059875|NCT00115492|Drug|Salmeterol|
12059876|NCT00115479|Drug|intensive insulin therapy to maintain normoglycemia|
12059877|NCT00115466|Procedure|Non-surgical autologous implant of ASCs|
12059878|NCT00115453|Radiation|irradiation|Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
12059879|NCT00115440|Radiation|Bononophenylalanine (BPA)-based BNCT|Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
12059880|NCT00115427|Drug|Liatermin (r-metHuGDNF)|
12059881|NCT00115414|Drug|pegfilgrastim|
12059882|NCT00115414|Drug|docetaxel|
12059883|NCT00115414|Drug|doxorubicin|
12059884|NCT00115414|Drug|cyclophosphamide|
12059885|NCT00019500|Drug|raloxifene|
12059886|NCT00019500|Procedure|evaluation of cancer risk factors|
12059887|NCT00115388|Procedure|Screening for chlamydia using self-taken vaginal swabs|Women in the intervention group will be tested for chlamydia and those found to be infected will be referred for treatment and partner notification
12059888|NCT00115375|Drug|Clopidogrel (SR25990)|
12059889|NCT00115362|Drug|venlafaxine|
12059890|NCT00115349|Drug|Deferoxamine|Deferoxamine will be given daily for 12-24h/day 7 days a week either subcutaneous or intravenous at up to 50-60 mg/kg/day.
12059891|NCT00115349|Drug|Deferiprone (L1)|The dose of L1, 75mg/kg in three divided oral doses, is the maximum dose at which toxicity has been tested in prospective trials
12059892|NCT00115336|Drug|Intravenous Ketorolac|Intravenous ketorolac
12059893|NCT00115336|Drug|Ibuprofen|Ibuprofen, taken orally
12059894|NCT00115323|Behavioral|Problem Solving|Problem solving intervention
12059895|NCT00115323|Behavioral|Attention Control|Attention control intervention
12059896|NCT00115310|Drug|NGX-4010|
12059897|NCT00115297|Drug|Montelukast|Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.
12059898|NCT00115297|Drug|Placebo|Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.
12059899|NCT00115284|Behavioral|ABIM asthma practice improvement module|
12059900|NCT00115271|Drug|Nutritional supplements|
12059901|NCT00115258|Other|parenteral nutrition titrated to measured REE|
12059902|NCT00115245|Drug|Telbivudine (LdT)|
12059903|NCT00115245|Drug|Adefovir Dipivoxil|
12059904|NCT00115219|Drug|Etanercept|
12059905|NCT00115206|Drug|Neulasta® (pegfilgrastim)|
12059906|NCT00115193|Drug|pegfilgrastim|pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
12059907|NCT00115193|Drug|pegfilgrastim|pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)
12059908|NCT00115180|Other|No intervention|No intervention
12059909|NCT00115167|Drug|Placebo|Q4W
12059910|NCT00115167|Drug|Darbepoetin alfa|Q4W
12059911|NCT00115154|Drug|Aldara (imiquimod) cream, 5%|
12059912|NCT00115141|Drug|Resiquimod|
12059913|NCT00115128|Drug|filgrastim|Normal donors being treated with filgrastim for PBPC mobilization and collection
12059914|NCT00115115|Drug|Dopamine infusion to brain dead organ donors|Dopamine infusion administered at a dosage of 4µg/kg/min starting after brain death has been proven until to surgical procurement of the kidneys
12059915|NCT00115102|Drug|fentanyl|
12059916|NCT00115102|Drug|S-ketamine|
12059917|NCT00115089|Drug|R926112|
12059918|NCT00115089|Drug|Beclomethasone dipropionate|
12059919|NCT00115076|Drug|Efalizumab|24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
12059920|NCT00115063|Behavioral|group sessions|group sessions lead by a trained primary care clinic employee
12059921|NCT00115063|Drug|sibutramine, orlistat, diethylpropion|dosage modified according to package insert instructions at discretion of primary care physicians
12059922|NCT00115063|Behavioral|Low Calorie Diet, Health One|liquid diet for 8-12 weeks to induce weight loss
12059923|NCT00115063|Other|Intensive Medical Combination Therapy for Obesity|"Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a Treatment Toolbox."
12059924|NCT00115063|Other|Control Condition|Access to the Mayo Clinic weight management website and usual care from the primary care physician
12059925|NCT00115050|Drug|TMC114|
12059926|NCT00115037|Drug|Naltrexone|100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
12059927|NCT00115037|Drug|placebo|placebo comparer for 16 weeks in phase 2.
12059928|NCT00115037|Behavioral|Medication Management (MM)|Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
12059929|NCT00115037|Behavioral|Combined Behavioral Intervention (CBI)|45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
12059930|NCT00115037|Behavioral|Telephone Counseling|Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.
12059931|NCT00115024|Drug|Micronized 17B-estradiol|
12059932|NCT00115011|Drug|Escitalopram|
12059933|NCT00114985|Device|Prostate Immobilization Device|Device placed during radiation treatment
12059934|NCT00114972|Device|Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent|Drug Eluting Stent
12059935|NCT00114972|Procedure|Coronary Artery Bypass Surgery|Coronary Artery Bypass Surgery
12059936|NCT00114959|Drug|Homoharringtonine|"Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous (IV) infusion daily on Days 1-5 of each 4 week treatment cycle. Participants who do not achieve a meaningful hematologic or cytogenetic response by the end of the fourth cycle are discontinued from the study. Otherwise, participants may continue additional cycles of this combined treatment for a maximum of 12 cycles.
~Participants who achieved a molecular or cytogenetic response, or a complete hematologic remission (CHR), could undergo subsequent cycles with a maintenance schedule of homoharringtonine 2.5 mg/m^2 by continuous 24-hour IV infusion daily for 2 days every 4 weeks. Dose escalations in subsequent cycles were allowed by one day at a time if the participant was unable to maintain CHR in the maintenance schedule."
12059937|NCT00114959|Drug|Imatinib Mesylate|Taken by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. For the first cycle of therapy only, imatinib was started on Day 4 of homoharringtonine treatment.
12059938|NCT00114946|Drug|Avastin|
12059939|NCT00114933|Drug|Stopping nucleosides and continuing lopinavir/ritonavir monotherapy|
12059940|NCT00114920|Drug|Resiquimod|
12059941|NCT00114907|Behavioral|Consumption of black tea|
12059942|NCT00114894|Other|Safe Sea ™|Safe Sea ™ applied one time at 2 mg/cm2 coverage
12059943|NCT00114894|Other|Placebo|Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage
12059944|NCT00114868|Drug|Vitamin A|
12059945|NCT00114855|Drug|HYPOCOL®|
12059946|NCT00114842|Procedure|MR colonography|
12059947|NCT00114829|Procedure|MR colonography with dynamic contrast uptake|
12059948|NCT00114816|Drug|capecitabine|
12059949|NCT00114816|Drug|docetaxel|
12059950|NCT00114803|Drug|Calcitonin nasal spray (salmon)|
12059951|NCT00114790|Radiation|boronophenylalanine-based BNCT|Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
12059952|NCT00114777|Drug|Cyclosporin A|tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months
12059953|NCT00114777|Drug|Belatacept Less Intensive Regimen (LI)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
12059954|NCT00114777|Drug|Belatacept More Intensive Regimen (MI)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
12059955|NCT00114764|Drug|filgrastim|Filgrastim given daily after induction chemotherapy
12059956|NCT00114764|Drug|pegfilgrastim|Pegfilgrastim given once after induction chemotherapy
12059957|NCT00114738|Drug|Rituximab (R)|Rituximab is given with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and bortezomib every 3 weeks for 6 cycles.
12059958|NCT00114738|Biological|EPOCH|EPOCH is given with Rituximab and bortezomib every 3 weeks for 6 cycles.
12059959|NCT00114738|Drug|Bortezomib (B)|Bortezomib is given alone for one cycle.
12059960|NCT00114738|Drug|Bortezomib|Bortezomib is given with EPOCH and rituximab every 6 weeks for 12 cycles.
12059961|NCT00114738|Drug|Bortezomib or observation|At the beginning of Part C, patients are randomized to receive bortezomib maintenance or be observed w/o bortezomib.
12059964|NCT00114686|Drug|Quetiapine fumarate|
12059965|NCT00114686|Drug|lithium|
12059966|NCT00114686|Drug|divalproex|
12059967|NCT00114660|Drug|Cocoa butter application|
12059968|NCT00114634|Dietary Supplement|Egg yolk preparation with cholesterol|Egg yolk preparation with cholesterol
12059969|NCT00114634|Dietary Supplement|Egg substitute, without cholesterol|Placebo control. Egg substitute, without cholesterol
12059970|NCT00114621|Drug|Anthrax Vaccine|
12059971|NCT00114621|Procedure|Blood Chemistry|
12059972|NCT00114621|Procedure|Hematology|
12059973|NCT00114621|Procedure|Urinalysis|
12059974|NCT00114608|Device|The Focus™ Neuromuscular Stimulation System|"Electrical foot stimulation was produced by surface electrodes placed on the sole of the foot over the plantar muscle group. Electrical stimulation was delivered by The Focus™ Neuromuscular Stimulation System, Empi, Inc. (St. Paul, MN.) The crucial stimulus parameters were: biphasic symmetrical square wave at 50 pulses per second, phase duration of 300 microseconds, a starting ramp up time of 2 seconds and a finishing ramp down time of 2 seconds per stimulation cycle, and a stimulation cycle of 12 seconds on and 48 seconds off per minute. Stimulation was increased to an intensity just sufficient to create a slight visible muscle twitch. This level of intensity caused no evident discomfort in any of the subjects in our first study. Subjects were continually monitored throughout this study for any indication of discomfort.The Focus™ Neuromuscular Stimulation System created electrical stimulation of the plantar foot muscles."
12059975|NCT00114595|Drug|eicosapentaenoic acid|
12059976|NCT00114582|Procedure|family style dinner|
12059977|NCT00114569|Drug|lorazepam|
12059978|NCT00114556|Drug|zoledronic acid|
12059979|NCT00114543|Procedure|Aggressive Phototherapy 501-750g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14.
12059980|NCT00114543|Procedure|Aggressive Phototherapy 751-1000g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-7, and started, stopped, and/or restarted when levels reach 7 mg/dl during days of life 8-14.
12059981|NCT00114543|Procedure|Conservative Phototherapy 501-750g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14.
12059982|NCT00114543|Procedure|Conservative Phototherapy 751-1000g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14.
12059983|NCT00114530|Biological|mHSCT|Hematopoietic progenitors were mobilized with G-CSF. After leukapheresis and CD34+ cell enrichment, the autologous product was cryopreserved. Fractionated TBI (800 cGy), CY (120 mg/kg) and equine antithymocyte globulin (90 mg/kg) were administered as previously reported (References provided in citation section of this ClinicalTrials.gov record: PubMed ID: 17452515 citation and 2.) PubMed ID: 12176878 citation).
12059984|NCT00114530|Drug|cyclophosphamide|An initial intravenous dose of 500 mg/m^2 was followed by 11 infusions of 750 mg/m^2 with mesna given for bladder protection.
12059985|NCT00114517|Drug|Oral 17B-estradiol|Oral 17B-estradiol 1 mg daily
12059986|NCT00114517|Drug|Placebo|Matched placebo oral 17B-estradiol
12059987|NCT00114504|Drug|simvastatin|simvastatin 5-10 mg/day
12059988|NCT00114491|Drug|Rosuvastatin|
12059989|NCT00114478|Drug|Epinephrine|
12059990|NCT00114478|Drug|albuterol (salbutamol)|
12059991|NCT00114465|Drug|VSL#3|VSL#3 1 sachet twice a day
12059992|NCT00114465|Other|Placebo|Placebo 1 sachel twice a day
12059993|NCT00114452|Biological|Provacel|ex vivo cultured adult mesenchymal stem cells
12059994|NCT00114452|Biological|Placebo|Placebo
12059995|NCT00114439|Drug|Lithium carbonate|
12059996|NCT00114426|Device|non-invasive mechanical ventilation|
12059997|NCT00114413|Drug|Inhaled corticosteroids|Used for both regular asthma control and as a rescue inhaler
12059998|NCT00114413|Procedure|eNO measurement|measured by Aerocrine® NIOX device
12059999|NCT00114400|Drug|folic acid|
12060000|NCT00114400|Drug|vitamin B12|
12060001|NCT00114400|Drug|vitamin B6|
12060002|NCT00114387|Drug|DL-alpha-tocopherol|
12060003|NCT00114374|Drug|Escitalopram|
12060004|NCT00114361|Drug|Ribavirin|1200 mg a day, 48 weeks
12060005|NCT00114361|Drug|Peginterferon alpha 2a|180 µg per week, 48 weeks
12060006|NCT00114348|Procedure|R-Blocks|
12060007|NCT00114348|Procedure|Protocol II-Ida|
12060008|NCT00114322|Device|light exposure from LED source at narrow 468 nm or broader 400-700 nm wavelength|
12060009|NCT00114309|Drug|131-I-TM-601|131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
12060010|NCT00114309|Drug|131I-TM601|131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
12060011|NCT00114296|Dietary Supplement|omega-3 fatty acid|
12060012|NCT00114283|Drug|lapatinib ditosylate|Given PO
12060013|NCT00114283|Other|laboratory biomarker analysis|Correlative studies
12060014|NCT00114270|Drug|letrozole|
12060015|NCT00114270|Drug|zoledronic acid|
12060016|NCT00114257|Drug|decitabine|
12060017|NCT00114257|Drug|romidepsin|
12060018|NCT00114244|Drug|sorafenib tosylate|Given PO
12060019|NCT00114244|Drug|gemcitabine hydrochloride|Given IV
12060020|NCT00114244|Other|laboratory biomarker analysis|Correlative studies
12060021|NCT00114231|Drug|capecitabine|
12060022|NCT00114231|Drug|oxaliplatin|Given IV
12060023|NCT00114231|Procedure|neoadjuvant therapy|Undergo surgery
12060024|NCT00114231|Radiation|radiation therapy|Undergo radiotherapy
12060025|NCT00114218|Drug|Gemcitabine Hydrochloride|Given IV
12060026|NCT00114218|Drug|Docetaxel|Given IV
12060027|NCT00114205|Drug|docetaxel|
12060028|NCT00114205|Procedure|therapeutic thoracoscopy|
12060029|NCT00114192|Drug|docetaxel|
12060030|NCT00114192|Drug|thalidomide|
12060031|NCT00114179|Drug|capecitabine|Given orally
12060032|NCT00114179|Radiation|radiation therapy|Undergo radiotherapy
12060033|NCT00114179|Biological|bevacizumab|Given IV
12060034|NCT00114179|Procedure|therapeutic conventional surgery|Undergo surgery
12060035|NCT00114179|Drug|gemcitabine hydrochloride|Given IV
12060036|NCT00114166|Drug|topotecan hydrochloride|
12060037|NCT00114153|Drug|capecitabine|
12060038|NCT00114153|Drug|carboplatin|
12060039|NCT00114153|Procedure|conventional surgery|
12060040|NCT00114153|Radiation|radiation therapy|
12060041|NCT00114140|Drug|Temozolomide|"Concurrent chemoradiotherapy temozolomide given 75 mg/m^2 daily during radiotherapy for 6 weeks.
~Post-Radiation Temozolomide given 150 mg/m2 daily on days 1-5 every 28 days with cycle one beginning 28 days post-radiotherapy. In the absence of grade 3 or 4 adverse events, a single dose escalation to 200 mg/m2/day could be attempted for cycle 2 and, if tolerated, that dose should continue for all subsequent cycles. Cycles were repeated every 28 days (+/- 2 days) for a total of 12 cycles."
12060042|NCT00114140|Radiation|Radiation therapy|One treatment of 1.8 Gy given daily, 5 days per week (over 6 weeks) for a total dose of 54.0 Gy.
12060043|NCT00114127|Drug|Duloxetine|60 mg duloxetine 1x per day
12060044|NCT00114127|Drug|Duloxetine|60 mg duloxetine 1x per day + 60mg duloxetine 1x per day
12060045|NCT00114127|Drug|Placebo|60mg placebo 1x per day
12060046|NCT00114114|Drug|Testosterone|Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
12060047|NCT00114114|Drug|Goserelin acetate|3.6 gms sc every 4 weeks
12060048|NCT00114101|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSCT
12060049|NCT00114101|Other|Laboratory Biomarker Analysis|Correlative studies
12060050|NCT00114101|Drug|Lenalidomide|Given PO
12060051|NCT00114101|Drug|Melphalan|Given IV
12060052|NCT00114101|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous PBSCT
12060053|NCT00114101|Other|Placebo Administration|Given PO
12060054|NCT00114088|Procedure|hysterectomy|
12060055|NCT00114088|Procedure|endometrial ablation|
12060056|NCT00114075|Procedure|Surgery with gait analysis report|Orthopaedic surgery with access to gait analysis report
12060057|NCT00114075|Procedure|Surgery without gait analysis report|Orthopaedic surgery without access to gait analysis report
12060058|NCT00114062|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
12060059|NCT00114049|Drug|GW406381|
12060060|NCT00114036|Behavioral|Quality improvement strategies|
12060061|NCT00114023|Drug|Imiquimod 5% cream|
12060062|NCT00114010|Drug|AMA1/Alhydrogel|
12060063|NCT00113997|Drug|REG1|
12060064|NCT00113984|Biological|PROSTVAC-V/TRICOM|
12060065|NCT00113984|Biological|PROSTVAC-F/TRICOM|
12060066|NCT00113984|Drug|MDX-010|
12060067|NCT00113984|Drug|Sargramostim|
12060068|NCT00113971|Drug|epratuzumab|
12060069|NCT00113958|Drug|Cinacalcet|
12060070|NCT00113945|Drug|Cinacalcet|
12060071|NCT00113932|Procedure|High-Dose Density Therapy|Dexamethasone 40mg po 1-4, Thalidomide 200 mg po 1-6hrs then daily after transplant; Cisplatin* 10 mg/m2 Continuous infusion 1-4;Adriamycin 10 mg/m2 Continuous infusion 1-4;Cyclophosphamide 400 mg/m2 Continuous infusion 1-4; Etoposide 40 mg/m2 Continuous infusion 1-4; Pegfilgrastim 6 mg subcutaneously 6 and 13; Darbepoetin 200μg subcutaneously Between -6 to-1 +12, & every 2 weeks until HB >12 gm/dl***; Lovenox (or other LMWH) 40 mg subcutaneously Daily until Pltcount <30,000/μl
12060072|NCT00113919|Drug|Busulfan|Dexamethasone 40 mg PO 1-4 Thalidomide 200 mg PO 1-6 Cisplatin* 10 mg/m, Continuous infusion 1-4 Adriamycin** 10 mg/m2, Continuous infusion 1-4 Cyclophosphamide 400 mg/2, Continuous infusion 1-4 Etoposide 40 mg/m2, Continuous infusion 1-4 All doses will be based on calculated body weight (actual weight + ideal body weight ÷ 2) and height, and not to exceed a BSA of 2.0 m2 The daily dose of cyclophosphamide, etoposide, and cisplatin will be mixed in a 1L bag of NS to be UAMS infused over 24 hours. Adriamycin will be mixed in at least 50cc D5W to be infused over 24 hours
12060073|NCT00113906|Drug|melatonin|
12060074|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 30 mg thrice daily (90 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
12060075|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 60 mg thrice daily (180 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
12060076|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 90 mg thrice daily (270 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
12060077|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 120 mg thrice daily (360 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
12060078|NCT00113880|Biological|FluMist|Nasal Sprayer dose of FluMist with annual follow up
12060079|NCT00113880|Biological|FluMist|Nasal Sprayer dose of FluMist with annual follow up
12060080|NCT00113880|Biological|FluMist|Nasal Sprayer dose of FluMist with annual follow up
12060081|NCT00113854|Drug|Mannitol|
12060082|NCT00113841|Drug|Curcumin|2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)
12060083|NCT00113841|Drug|Bioperine|5 mg (Tablets) orally twice daily
12060084|NCT00113828|Procedure|Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant|"Rabbit anti-thymocyte globulin 0.5 mg/kg on transplant day-8, 2.5 mg/kg on day-7 and 3.0 mg/kg on day-6; cyclophosphamide 60 mg/kg on days-7,-6; fludarabine 25 mg/m2 on days -5, -4, -3, -2, -1.
~Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant."
12060085|NCT00113828|Procedure|T-cell depleted peripheral blood stem cell transplant|"Rabbit anti-thymocyte globulin 0.5 mg/kg on transplant day-8, 2.5 mg/kg on day-7, 3.0 mg/kg on day-6; cyclophosphamide 60 mg/kg on days -7, -6; fludarabine 25 mg/m2 on days -5 through -1.
~T-cell depleted peripheral blood stem cell transplant ."
12060086|NCT00113815|Drug|topiramate|15 mg/kg/day
12060087|NCT00113815|Drug|topiramate|5 mg/kg/day
12060088|NCT00113815|Drug|topiramate|25 mg/kg/day
12060089|NCT00113815|Drug|placebo|placebo
12060090|NCT00113802|Drug|Epratuzumab (hLL2- anti-CD22 humanized antibody)|
12060091|NCT00113789|Other|PI Discretion|PI Discretion
12060092|NCT00113776|Drug|ABX-EGF|
12060093|NCT00113763|Other|Best supportive care|Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases).
12060094|NCT00113763|Drug|Panitumumab|Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.
12060095|NCT00113750|Biological|TreeMATA MPL|
12060096|NCT00113737|Drug|fluoxetine|
12060097|NCT00113737|Behavioral|cognitive behavioral therapy|
12060098|NCT00113724|Drug|TPI 287 Injection|
12060099|NCT00113711|Behavioral|smoking cessation|
12060100|NCT00113711|Behavioral|reducing diet|
12060101|NCT00113698|Drug|Enalapril|Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
12060102|NCT00113698|Other|Placebo|Placebo An inert preparation with similar appearance and taste to the drug
12060103|NCT00113685|Drug|Hypertonic Saline-Dextran Solution|
12060104|NCT00113685|Drug|Lactated Ringer's Solution|
12060105|NCT00113672|Behavioral|Increase healthy activity and increase healthy eating|Increase participants to 60 minutes of activity per day and 5 fruits and vegetables per day over a 3 week prescription phase
12060106|NCT00113672|Behavioral|Decrease unhealthy activity and increase healthy eating|Decrease sedentary activity by 90 minutes per day and increase fruits and vegetables to 5 servings per day over the course of a 3 week prescription phase
12060107|NCT00113672|Behavioral|Increase physical activity and decrease unhealthy eating|Increase physical activity up to 60 minutes per day and decrease saturated fat to an average of 8% per day over the course of a 3 week prescription phase
12060108|NCT00113672|Behavioral|Decrease sedentary activity and decrease unhealthy eating|Decrease sedentary activity by 90 minutes per day and decrease saturated fat to and average of 8% per day over the course of a 3 week prescription phase
12060109|NCT00113659|Dietary Supplement|Probiotic|Daily dose of ten to the tenth colony-forming units of Lactobacillus GG and 225 mg of inulin for the first 6 months of life.
12060110|NCT00113659|Dietary Supplement|Placebo|Daily dose of placebo supplement containing 325mg inulin for the first 6 month of life.
12060111|NCT00113646|Drug|MEDI-507|MEDI-507 0.1 mg/kg on transplant day-8, 0.6 mg/kg on days-7 and -6
12060112|NCT00113646|Procedure|Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant|Cyclophosphamide 60 mg/kg on transplant days -7 and -6; Fludarabine 25 mg/m2 days -5,-4,-3,-2,-1; MEDI-507 0.1 mg/kg on day -8, 0.6 mg/kg on days -7,-6
12060113|NCT00113633|Behavioral|Intervention Subjects|The subject's family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups; a mailed reminder will be sent to the family to schedule a follow-up appointment.
12060114|NCT00113620|Drug|Neurodex|
12060115|NCT00113607|Drug|Trabectedin|Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.
12060116|NCT00113607|Drug|DOXIL|Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.
12060117|NCT00113607|Drug|Dexamethasone|Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.
12060118|NCT00113594|Drug|Olanzapine|
12060119|NCT00113581|Drug|EMD 72000 (matuzumab) + ECX|
12060120|NCT00113568|Drug|Tranexamic acid tablets (XP12B)|Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation
12060121|NCT00113555|Device|ACT (Adjustable Continence Therapy)|surgically implanted device
12060122|NCT00113542|Drug|Tetrathiomolybdate (TM)|
12060123|NCT00113529|Drug|Gefitinib + Sunitinib|Until disease progression or unacceptable toxicity.
12060124|NCT00113516|Drug|carboplatin|AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.
12060125|NCT00113516|Drug|paclitaxel|175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.
12060126|NCT00113516|Drug|sunitinib|50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).
12060127|NCT00113503|Drug|Azathioprine weight-based dose|
12060128|NCT00113503|Drug|Azathioprine individualised dose|
12060129|NCT00113490|Biological|motavizumab (MEDI-524)|Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.
12060130|NCT00113490|Biological|palivizumab 15 mg/kg|Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.
12060131|NCT00113477|Drug|Q10|
12060132|NCT00113477|Drug|Selen|
12060133|NCT00113438|Drug|Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin|Combretastatin A-4 Phosphate is administered IV at 45 mg/m2 or 60 mg/m2 on Days 1, 8 and 15 followed by paclitaxel (3 hour infusion at 200 mg/m2) and carboplatin (1 hour infusion at AUC = 6) on Day 2 of each cycle. The treatment cycle is 21 days with a maximum of 21 days. Following cycle 6, subjects that have not progressed may continue on CA4P monotherapy, which will be administered at 45 mg/m2 or 60 mg/m2 on Days 1 and 8 with rest on Day 15, repeated every 21 days until disease progression.
12060134|NCT00113425|Device|V-Beam laser, Candela Corp., 595 nm wavelength|Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.
12060135|NCT00113412|Drug|SP01A|
12060136|NCT00113399|Biological|filgrastim|
12060137|NCT00113399|Drug|cisplatin|
12060138|NCT00113399|Drug|docetaxel|
12060139|NCT00113399|Drug|fluorouracil|
12060140|NCT00113399|Drug|paclitaxel|
12060141|NCT00113399|Radiation|radiation therapy|
12060142|NCT00113386|Biological|filgrastim|Consolidation chemotherapy
12060143|NCT00113386|Biological|pegfilgrastim|Consolidation chemotherapy
12060144|NCT00113386|Drug|cisplatin|
12060145|NCT00113386|Drug|docetaxel|
12060146|NCT00113386|Procedure|adjuvant therapy|
12060147|NCT00113386|Procedure|conventional surgery|
12060148|NCT00113386|Procedure|neoadjuvant therapy|
12060149|NCT00113386|Radiation|radiation therapy|
12060150|NCT00113373|Drug|lapatinib ditosylate|Given orally
12060151|NCT00113373|Other|laboratory biomarker analysis|Correlative studies
12060152|NCT00113360|Drug|RAD001|Starting dose of 5 or 10 mg by mouth daily.
12060153|NCT00113360|Drug|Octreotide Depot|30 mg injection into the muscle of either buttock once every 28 (±7) days.
12060154|NCT00113347|Drug|Erlotinib|Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.
12060155|NCT00113347|Drug|Docetaxel|15 mg/m^2 or 20 mg/m^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
12060156|NCT00113347|Radiation|Radiation Therapy|Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.
12060157|NCT00113334|Drug|ABT-510|100 mg subcutaneously twice daily
12060158|NCT00113321|Drug|Decitabine|20 mg/m2 IV over 1 hour daily x 5 days.
12060159|NCT00113308|Drug|GW406381|
12060160|NCT00113295|Drug|Continued Paroxetine CR|
12060161|NCT00113295|Drug|Quetiapine|
12060162|NCT00113295|Drug|Placebo|
12060163|NCT00113282|Drug|Interleukin-2 (IL-2)|
12060164|NCT00113269|Drug|basiliximab|IV
12060165|NCT00113269|Drug|rabbit anti-thymocyte globulin|IV
12060166|NCT00113269|Drug|tacrolimus|oral
12060167|NCT00113269|Drug|alemtuzumab|Intravenous (IV)
12060168|NCT00113269|Drug|mycophenolate mofetil|oral
12060169|NCT00113269|Drug|steroids|IV and/or oral
12060170|NCT00113256|Drug|Rubitecan|
12060171|NCT00113243|Drug|adult stem cells|
12060172|NCT00113230|Drug|Avastin (Bevacizumab, RHUMAB VEGF)|Starting Dose 5 mg/kg intravenously on day one of radiotherapy, given every 2 weeks +/- 2 days for a total of 3 doses.
12060173|NCT00113230|Drug|Capecitabine|900 mg/m^2 by mouth twice a day during days of radiation for all five weeks of therapy.
12060174|NCT00113230|Radiation|Radiation Therapy|45 Gy in 25 fractions to the pelvis followed by 5.4 Gy as a boost dose to the primary tumor with margin, for a total dose of 50.4 Gy over 28 treatment days.
12060175|NCT00113217|Drug|Bevacizumab|10 mg/kg IV on day 1 of each 14-day cycle.
12060176|NCT00113204|Drug|IPI-504|
12060177|NCT00113191|Drug|Veronate|
12060178|NCT00113178|Device|Catheter-based cardiac cryoablation|
12060179|NCT00113165|Drug|LAMICTAL extended-release|
12060180|NCT00113139|Behavioral|Telephone-based coping skills/stress management|Telephone-based coping skills/stress management: 12 weekly sessions.
12060181|NCT00113139|Other|Usual Care|Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.
12060182|NCT00113126|Drug|Treatment interruption|
12060183|NCT00113113|Drug|Rubitecan|
12060184|NCT00113100|Drug|Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)|
12060185|NCT00113087|Drug|Enalapril|Enalapril to target dose of .4mg/kg/day divided to twice per day (BID)
12060186|NCT00113087|Drug|Placebo|Participants will receive placebo
12060187|NCT00113074|Drug|Nicotine Replacement Therapy|Nicotine replacement therapy program
12060188|NCT00113074|Behavioral|Diet|Diet program
12060189|NCT00113061|Procedure|Exercise|
12060190|NCT00113048|Drug|CAMPATH (alemtuzumab)|
12060191|NCT00113022|Drug|Org 24448|250 mg once per day for first week, 250 mg twice per day for second week, 500 mg twice per day for third and fourth weeks, if response minimal or worse at four weeks then 750 mg twice per day for additional weeks
12060192|NCT00113022|Drug|Placebo|Inactive equivalent of 250 mg once per day for first week, 250 mg twice per day for second week, 500 mg twice per day for third and fourth weeks, if response minimal or worse at four weeks then 750 mg twice per day for additional weeks
12060193|NCT00113009|Drug|VLTS-934|
12060194|NCT00112996|Drug|alpha-lipoic acid|Oral two 300 mg ALA sustained release tablets initiated 4 days after last dose of platinum and discontinued 2 days before next scheduled platinum dose, continued for 24 weeks.
12060195|NCT00112996|Other|placebo|Given orally two similar color and sized placebo control tablets three times a day continued for 24 weeks.
12060196|NCT00112983|Biological|eculizumab|
12060197|NCT00112957|Biological|rV-NY-ESO-1 vaccine|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1.
12060198|NCT00112957|Biological|rF-NY-ESO-1 vaccine|Patients received subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169.
12060199|NCT00112931|Biological|rituximab|
12060200|NCT00112931|Other|No treatment|
12060201|NCT00112918|Biological|Bevacizumab|Administered as an intravenous infusion over 30 - 90 minutes.
12060202|NCT00112918|Drug|Capecitabine|Film-coated tablets
12060203|NCT00112918|Drug|5-Fluorouracil (5-FU)|Administered as either a bolus injection or continuous intravenous infusion over 22 hours.
12060204|NCT00112918|Drug|Leucovorin calcium|Administered as a 200 mg/m^2 infusion over 2 hours.
12060205|NCT00112918|Drug|Oxaliplatin|Administered as an intravenous infusion over 2 hours.
12060206|NCT00112905|Drug|sorafenib tosylate|Given PO
12060207|NCT00112905|Other|laboratory biomarker analysis|Optional correlative studies
12060208|NCT00112892|Dietary Supplement|selenium|
12060209|NCT00112892|Drug|irinotecan hydrochloride|
12060210|NCT00112879|Drug|arsenic trioxide|
12060211|NCT00112879|Drug|ascorbic acid|
12060212|NCT00112879|Drug|dexamethasone|
12060213|NCT00112879|Drug|thalidomide|
12060214|NCT00112879|Procedure|anti-cytokine therapy|
12060215|NCT00112879|Procedure|antiangiogenesis therapy|
12060216|NCT00112879|Procedure|biological therapy|
12060217|NCT00112879|Procedure|chemotherapy|
12060218|NCT00112879|Procedure|drug resistance inhibition|
12060219|NCT00112879|Procedure|growth factor antagonist therapy|
12060220|NCT00112879|Procedure|non-specific immune-modulator therapy|
12060221|NCT00112866|Drug|cilengitide|Given IV
12060222|NCT00112866|Procedure|therapeutic conventional surgery|Undergo tumor resection
12060223|NCT00112866|Other|pharmacological study|Correlative studies
12060224|NCT00112866|Other|laboratory biomarker analysis|Correlative studies
12060225|NCT00112853|Drug|tipifarnib|Given orally
12060226|NCT00112853|Drug|etoposide|Given orally
12060227|NCT00112840|Drug|CCI-779|CCI-779 is taken IV on days 1, 8, 15, 22 of a 28-day cycle. Dose level is dependent on phase.
12060228|NCT00112840|Drug|Bevacizumab|Bevacizumab is taken IV on Days 1 and 15 of a 28-day cycle. Dose Level determined by phase.
12060229|NCT00112827|Radiation|total marrow irradiation|Undergo irradiation
12060230|NCT00112827|Drug|melphalan|Given IV
12060231|NCT00112827|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
12060232|NCT00112827|Biological|filgrastim|Given IV
12060233|NCT00112827|Genetic|fluorescence in situ hybridization|Correlative studies
12060234|NCT00112827|Genetic|cytogenetic analysis|Correlative studies
12060235|NCT00112827|Drug|cyclophosphamide|Given IV
12060236|NCT00112827|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|Undergo transplantation
12060237|NCT00112827|Drug|lenalidomide|Given orally
12060238|NCT00112775|Drug|dasatinib|
12060239|NCT00112775|Drug|imatinib mesylate|
12060240|NCT00112749|Biological|infliximab|A single infusion of 1mg/kg will be administered.
12060241|NCT00112749|Other|Clinical Assessment|Medical, psychiatric, and immune evaluation.
12060242|NCT00112749|Other|Self-report questionnaires|Fatigue Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Hamilton Depression Rating Scale, Beck Depression Inventory II, Hamilton anxiety Rating Scale, Pittsburgh Sleep Quality Index, Brief Pain Inventory, MOS SF-36.
12060243|NCT00112749|Other|Immune Assessment|Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.
12060244|NCT00112736|Drug|erlotinib|Given orally
12060245|NCT00112736|Drug|temsirolimus|Given IV
12060246|NCT00112736|Procedure|therapeutic conventional surgery|Undergo surgical resection
12060247|NCT00112736|Other|laboratory biomarker analysis|Correlative studies
12060248|NCT00112736|Other|pharmacological study|Correlative studies
12060249|NCT00112723|Drug|alvocidib|Given IV
12060250|NCT00112710|Drug|carboplatin|
12060251|NCT00112710|Drug|cisplatin|
12060252|NCT00112710|Drug|gemcitabine hydrochloride|
12060253|NCT00112697|Drug|cisplatin|
12060254|NCT00112697|Drug|docetaxel|
12060255|NCT00112697|Drug|fluorouracil|
12060256|NCT00112697|Radiation|radiation therapy|
12060257|NCT00112684|Drug|alvocidib|Given IV
12060258|NCT00112684|Other|pharmacological study|Correlative studies
12060259|NCT00112684|Other|laboratory biomarker analysis|Correlative studies
12060260|NCT00112671|Drug|sorafenib tosylate|Given orally 400mg orally twice daily
12060261|NCT00112671|Other|laboratory biomarker analysis|Correlative studies
12060262|NCT00112658|Drug|fluorouracil|
12060263|NCT00112658|Drug|gemcitabine hydrochloride|
12060264|NCT00112658|Drug|irinotecan hydrochloride|
12060265|NCT00112658|Drug|leucovorin calcium|
12060266|NCT00112658|Drug|oxaliplatin|
12060267|NCT00112645|Biological|anti-thymocyte globulin|
12060268|NCT00112645|Drug|busulfan|
12060269|NCT00112645|Drug|cyclosporine|
12060270|NCT00112645|Drug|melphalan|
12060271|NCT00112645|Drug|methotrexate|
12060272|NCT00112645|Drug|methylprednisolone|
12060273|NCT00112645|Procedure|allogeneic bone marrow transplantation|
12060274|NCT00112645|Procedure|peripheral blood stem cell transplantation|
12060275|NCT00112645|Procedure|umbilical cord blood transplantation|
12060276|NCT00112632|Drug|imatinib mesylate|
12060277|NCT00112632|Procedure|conventional surgery|
12060278|NCT00112632|Procedure|neoadjuvant therapy|
12060279|NCT00112619|Drug|topotecan hydrochloride|Participants receive intraventricular topotecan, .2 mg, administered via an indwelling ventricular reservoir daily for 5 consecutive days during weeks 1 and 3 of the first four weeks of therapy (induction), during weeks 5 and 8 of the next 6 weeks of therapy (consolidation), and during weeks 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, and 51 (maintenance therapy).
12060280|NCT00112593|Drug|fludarabine phosphate|Given IV
12060281|NCT00112593|Radiation|total-body irradiation|Undergo TBI
12060282|NCT00112593|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
12060283|NCT00112593|Drug|cyclosporine|Given IV or PO
12060284|NCT00112593|Drug|mycophenolate mofetil|Given IV or PO
12060285|NCT00112593|Other|laboratory biomarker analysis|Correlative studies
12060286|NCT00112580|Biological|ipilimumab|
12060287|NCT00112567|Drug|fludarabine phosphate|
12060288|NCT00112567|Drug|thiotepa|
12060289|NCT00112567|Procedure|peripheral blood stem cell transplantation|
12060290|NCT00112567|Radiation|radiation therapy|
12060291|NCT00112554|Drug|cytarabine|Given IV
12060292|NCT00112554|Drug|laromustine|Given IV
12060293|NCT00112554|Other|placebo|Given IV
12060294|NCT00112528|Biological|bevacizumab|
12060295|NCT00112528|Drug|gemcitabine hydrochloride|
12060296|NCT00112528|Drug|oxaliplatin|
12060297|NCT00112515|Drug|modafinil|
12060298|NCT00112515|Procedure|cognitive assessment|
12060299|NCT00112515|Procedure|psychosocial assessment and care|
12060300|NCT00112515|Procedure|quality-of-life assessment|
12060301|NCT00112502|Drug|Celecoxib|400 mg orally twice a day continuous dosing
12060302|NCT00112502|Drug|Isotretinoin|40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
12060303|NCT00112502|Drug|Temozolomide|150 mg/m2 orally daily, 7 days on treatment, 7 days off.
12060350|NCT00112216|Biological|FluMa peptide|
12060351|NCT00112216|Biological|Mage-A10 peptide|
12060304|NCT00112502|Drug|Thalidomide|400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
12060305|NCT00112489|Drug|carboplatin|
12060306|NCT00112489|Drug|paclitaxel|
12060307|NCT00112476|Drug|bryostatin 1|Given IV
12060308|NCT00112476|Drug|temsirolimus|Given IV
12060309|NCT00112463|Drug|romidepsin|DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.
12060310|NCT00112437|Drug|Odanacatib|Odanacatib 3 mg, once weekly for 24 months
12060311|NCT00112437|Drug|Odanacatib|Odanacatib 10 mg, once weekly for 24 months
12060312|NCT00112437|Drug|Odanacatib|Odanacatib 25 mg, once weekly for 24 months
12060313|NCT00112437|Drug|Odanacatib|Odanacatib 50 mg, once weekly for 24 months
12060314|NCT00112437|Dietary Supplement|Vitamin D3|Vitamin D3, two 2800 IU weekly throughout the study
12060315|NCT00112437|Dietary Supplement|Calcium Carbonate|Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
12060316|NCT00112437|Drug|Placebo|Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months
12060317|NCT00112424|Procedure|Diagnostic cardiac MRI|Routine cardiac MRI done under general anesthesia as pre-operative evaluation.
12060318|NCT00112424|Procedure|Cardiac catheterization|Routine cardiac catheterization prior to Glenn operation.
12060319|NCT00112411|Drug|Bronchodilator|
12060320|NCT00112398|Procedure|Extended interventions by advanced level prehospital providers|may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
12060321|NCT00112385|Drug|Etanercept|Etanercept 50 mg will be injected subcutaneously once per week for 52 weeks
12060322|NCT00112385|Drug|Placebo|Placebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks.
12060323|NCT00112372|Drug|Ridaforolimus|10 mg tablet of ridaforolimus administered orally according to one of several different dosing regimens for a four-week treatment cycle.
12060324|NCT00112359|Drug|AZLI 75 mg three times a day (TID)|
12060325|NCT00112359|Drug|Placebo three times a day (TID)|
12060326|NCT00112346|Drug|Cetuximab + platinum + gemcitabine|Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
12060327|NCT00112346|Drug|Platinum + Gemcitabine|Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.
12060328|NCT00112333|Procedure|fMRI|A liquid meal (Ensure 1Kcal/cc) will be infused into the stomach via a nasogastric tube at a rate of 60cc/min till the subject reaches maximal satiety. The amount of liquid meal will differ per subject.
12060329|NCT00112320|Procedure|PVR plus RV remodeling|PVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume
12060330|NCT00112320|Procedure|Standard PVR|PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm
12060331|NCT00112307|Procedure|Brachytherapy|
12060332|NCT00112294|Drug|Paclitaxel (Taxane)|IV, 225 mg/m^2
12060333|NCT00112294|Drug|Docetaxel (Taxane)|IV, 75 mg/m^2
12060334|NCT00112294|Drug|Carboplatin|AUC=6, q 3 weeks (6 cycles maximum)
12060335|NCT00112294|Drug|Cetuximab|Intravenous, 400 mg/m^2, initial dose followed by 250 mg/m^2, weekly starting on Week 2
12060336|NCT00112281|Drug|Tilarginine Acetate Injection intravenous infusion|
12060337|NCT00112268|Behavioral|QuitLink (office support system for quit line referral)|
12060338|NCT00112255|Behavioral|Practice nurse-led partner notification|
12060339|NCT00112255|Behavioral|Referral to specialist genitourinary clinic|
12060340|NCT00112242|Biological|Melan-A ELA + Montanide|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
12060341|NCT00112242|Biological|Melan-A ELA + NY-ESO-1b + MAGE-A10 + Montanide|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
12060342|NCT00112242|Biological|Melan-A -ELA + NY-ESO-1b + MAGE-A10 peptide + Montanide + CpG|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
12060343|NCT00112242|Biological|Melan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
12060344|NCT00112242|Biological|Melan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG+ IL-2|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
12060345|NCT00112229|Biological|group 1|Melan-A analog peptide + CpG + Montanide
12060346|NCT00112229|Biological|group 2|Melan-A natural peptide + CpG + Montanide
12060347|NCT00112229|Biological|group 3|Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
12060348|NCT00112229|Biological|group 4|Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide
12060349|NCT00112216|Biological|Melan-A analog peptide|
12060471|NCT00111306|Drug|epratuzumab|
12060352|NCT00112216|Biological|SB AS-2 adjuvant|
12060353|NCT00112216|Biological|Montanide adjuvant|
12060354|NCT00112203|Drug|Itopride|
12060355|NCT00112190|Drug|Itopride Hydrochloride|100 mg tid
12060356|NCT00112190|Drug|itopride|100 mg three times daily
12060357|NCT00112177|Drug|Itopride Hydrochloride|
12060358|NCT00112164|Drug|Xigris|
12060359|NCT00112151|Drug|LowT|Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.
12060360|NCT00112151|Behavioral|Resistance Training|Weight training 45-60 minutes 3 times per week
12060361|NCT00112151|Drug|Placebo|2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
12060362|NCT00112151|Drug|HighT|High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.
12060363|NCT00112138|Drug|gabapentin|
12060364|NCT00112125|Device|OPTIMIZER System|
12060365|NCT00112112|Biological|FluMist|"The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like.
~brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm."
12060366|NCT00112112|Biological|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
12060367|NCT00112099|Procedure|Surgery: Splenectomy|Procedure/Surgery: Surgery: Splenectomy
12060368|NCT00112099|Procedure|Surgery: Spleen-preservation|Procedure/Surgery: Surgery: Spleen-preservation
12060369|NCT00112086|Drug|Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)|
12060370|NCT00112073|Drug|bapineuzumab|IV, Q13w
12060371|NCT00112073|Other|placebo|IV Q13w
12060372|NCT00112060|Drug|PT-523 for Injection|
12060373|NCT00112047|Drug|Emtricitabine (FTC)|Capsule containing 200 mg FTC, taken once daily, for 96 weeks
12060374|NCT00112047|Drug|Tenofovir Disoproxil Fumarate (TDF)|Tablet containing 300 mg TDF, taken once daily, for 96 weeks
12060375|NCT00112047|Drug|Efavirenz (EFV)|Tablet containing 600 mg EFV, taken once daily, for 96 weeks
12060376|NCT00112047|Drug|FTC/TDF|Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144
12060377|NCT00112047|Drug|FTC/TDF/EFV|Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240
12060378|NCT00112047|Drug|Lamivudine/zidovudine|Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks
12060379|NCT00112034|Drug|Methotrexate|
12060380|NCT00112034|Drug|IV methylprednisolone|
12060381|NCT00112021|Drug|pramlintide acetate|
12060382|NCT00112008|Drug|De Novo Administration of Darbepoetin Alfa|Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL
12060383|NCT00111995|Drug|Aranesp®|
12060384|NCT00111982|Biological|Liatermin|Liatermin
12060385|NCT00111969|Device|Celacade™ system|
12060386|NCT00111956|Drug|Etanercept|
12060387|NCT00111956|Drug|Placebo|
12060388|NCT00111943|Drug|1% tenofovir gel|
12060389|NCT00111930|Drug|DHEA|
12060390|NCT00111917|Drug|Infliximab|anti-TNF
12060391|NCT00111917|Other|Placebo|Placebo infusion
12060392|NCT00111904|Drug|paclitaxel-loaded polymeric micelle|
12060393|NCT00111891|Drug|niacin (+) laropiprant|
12060394|NCT00111891|Drug|Comparator: placebo (unspecified)|
12060395|NCT00111878|Drug|MEDI-534|
12060396|NCT00111865|Behavioral|Aerobic Exercise Training|The exercise group will perform supervised stationary cycle ergometer exercise 3 days/week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 80% of their VO2 reserve over the course of the intervention.
12060397|NCT00111852|Drug|Desmoteplase|Desmoteplase 90 mcg/kg, intravenous administration.
12060398|NCT00111852|Drug|Desmoteplase|Desmoteplase 125 mcg/kg, intravenous administration.
12060399|NCT00111852|Drug|Placebo|Dose-Match Placebo, intravenous administration.
12060400|NCT00111839|Drug|Pemetrexed|Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.
12060401|NCT00111839|Drug|Matuzumab|Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.
12060402|NCT00111826|Device|Celacade™ system|
12060403|NCT00111813|Drug|vorinostat|Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
12060404|NCT00111813|Drug|bortezomib|Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
12060405|NCT00111800|Drug|Placebo|Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
12060406|NCT00111800|Drug|DEN 2.5 mg|DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
12060407|NCT00111800|Drug|DEN 7.5 mg|DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
12060408|NCT00111800|Drug|DEN 15 mg|DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
12060409|NCT00111800|Drug|DEN 30 mg|DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
12060410|NCT00111800|Drug|DEN 45 mg|DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
12060472|NCT00111280|Drug|TMC125|
12060411|NCT00111787|Drug|Lapatinib|Daily-monotherapy [1500 milligrams (mg)] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
12060412|NCT00111787|Drug|Paclitaxel|Weekly (80mg/m^2) combination therapy (with daily Lapatinib) for 12 weeks
12060413|NCT00111774|Drug|ABX-EGF|
12060414|NCT00111761|Drug|Irinotecan|Part 1: 125 mg/m^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m^2 IV infusion every other week until disease progression or unable to tolerate.
12060415|NCT00111761|Biological|Panitumumab|Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles.
12060416|NCT00111761|Drug|5-Fluorouracil|Part 1: IV bolus 500 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m^2 and infusional 2400-3000 mg/m^2 over 46 hours once every other week until disease progression or unable to tolerate.
12060417|NCT00111761|Drug|Leucovorin|Part 1: IV bolus 20 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m^2 every other week until disease progression or unable to tolerate.
12060418|NCT00111748|Drug|Velcade, Thalidomide, Dexamethasone|"Dosage and Administration Schedule Each cycle will consist of 3 weeks (21 days). AGENT DOSE ROUTE DAYS Velcade 1.0 mg/m2 IV 1, 4, 8, and 11 Thalidomide 100 mg PO Daily, hs Dexamethasone 20 mg PO Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg SQ Days 1-14
~This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). The next cycle of treatment may be delayed up to day 29 due to non-toxicity reasons. Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a maximum of eight cycles. At the discretion of the treating physician, patients may be eligible to receive treatment at their local physician after completion of the 1st cycle. These patients will need to return to MIRT prior to every cycle for cycles 2-4, cycles 6 and 8, and final visit."
12060419|NCT00111735|Drug|Thyroxine|
12060420|NCT00111722|Drug|MK0462, rizatriptan benzoate / Duration of Treatment -1day|
12060421|NCT00111722|Drug|Comparator: placebo / Duration of Treatment - 1 day|
12060422|NCT00111709|Drug|MK0462, rizatriptan benzoate / Duration of Treatment -1 day|
12060423|NCT00111709|Drug|Comparator: placebo / Duration of Treatment - 1 day|
12060424|NCT00111696|Biological|MEDI-522|Supplied at a concentration of 50 mg/mL in both 2 mL and 10mL vials
12060425|NCT00111683|Drug|MK0457|
12060426|NCT00111670|Drug|DPP-IV Inhibitor|Escalating doses po bid or qd
12060427|NCT00111670|Drug|Placebo|po bid or qd
12060428|NCT00111657|Biological|Pegloticase|8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5
12060429|NCT00111644|Drug|Ceftriaxone|1000mg iv daily
12060430|NCT00111644|Drug|beta-lactam|750mg iv q 23h for 3-14 days
12060431|NCT00111644|Drug|beta-lactam|1500mg iv q 12h for 3-14 days
12060432|NCT00111631|Drug|DPP-IV Inhibitor|Escalating doses po bid
12060433|NCT00111631|Drug|Metformin|As prescribed
12060434|NCT00111631|Drug|Placebo|po bid
12060435|NCT00111618|Drug|AS1404 (DMXAA)|
12060436|NCT00111605|Biological|HIV-1 gag DNA|A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid
12060437|NCT00111605|Biological|HIV-1 gag DNA plus IL-12 DNA adjuvant|Injection IL-12 DNA adjuvant intramuscularly into the deltoid
12060438|NCT00111605|Biological|CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)|A 1 mL intramuscular injection in the deltoid
12060439|NCT00111605|Biological|Sodium chloride injection (0.9%)|"All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid.
~Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273."
12060440|NCT00111592|Procedure|current usual care|current usual care
12060441|NCT00111592|Procedure|treatment protocol with clear indications for therapy|treatment protocol with clear indications for therapy
12060442|NCT00111579|Biological|CAIV-T|A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses.
12060443|NCT00111579|Other|TIV|A total vol. of 0.25 will be administered intramuscularly for each of two doeses.
12060444|NCT00111566|Drug|eptifibatide|
12060445|NCT00111553|Biological|Leish-111f + MPL-SE vaccine|
12060446|NCT00111540|Drug|exenatide|subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
12060447|NCT00111527|Other|Optimized echo-guided CRT pacing|Echo-TDI guided VV-delay optimization
12060448|NCT00111527|Other|normal RV pacing|PM or ICD implant according to patient indication
12060449|NCT00111514|Biological|Leish-111f + MPL-SE vaccine|
12060450|NCT00111501|Behavioral|Tobacco Use Disorder|Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component
12060451|NCT00111501|Behavioral|Standard Web-based intervention|General psychoeducational Web-based smoking cessation intervention
12060452|NCT00111488|Device|Flex 4 and Generator|
12060453|NCT00111475|Drug|Romiplostim|Administered by subcutaneous injection
12060454|NCT00111475|Drug|Placebo|Administered by subcutaneous injection
12060455|NCT00111462|Drug|Darbepoetin alfa|
12060456|NCT00111449|Drug|Etanercept|
12060457|NCT00111436|Drug|Etanercept|Enbrel 50 mg once weekly or 50 mg twice weekly
12060458|NCT00111423|Drug|Pegsunercept (PEG sTNF-RI)|
12060459|NCT00111410|Drug|Anakinra (r-metHuIL-1ra)|
12060460|NCT00111397|Procedure|Cytokine therapy|
12060461|NCT00111397|Drug|Interferon Gamma, GM-CSF|
12060462|NCT00111371|Drug|Levodopa|
12060463|NCT00111358|Behavioral|Lifestyle Modification|
12060464|NCT00111358|Other|No lifestyle modification|
12060465|NCT00111345|Drug|Anthracyclines|3x12 mg/qm
12060466|NCT00111345|Drug|liposomal daunorubicin|3x80 mg/qm
12060467|NCT00111345|Drug|2-CDA|2x6 mg/qm
12060468|NCT00111345|Drug|AI|AI
12060469|NCT00111332|Behavioral|Progressive resistance and aerobic training|
12060470|NCT00111319|Drug|bortezomib|
12060473|NCT00111267|Behavioral|vitamin B12 supplementation|
12060474|NCT00111267|Behavioral|vitamin B12 + folic acid combined supplementation|
12060475|NCT00111254|Procedure|Microdermabrasion|Treatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device).
12060476|NCT00111241|Drug|aromatase inhibitors (letrozole, anastrozole)|Women prescribed an aromatase inhibitor by their clinician were compared with healthy controls in the community who had been recruited to a prior study
12060477|NCT00111228|Device|Guardian RT|
12060478|NCT00111228|Device|SMBG only|SMBG only
12060479|NCT00111215|Drug|Tranexamic Acid|
12060480|NCT00111215|Drug|Desmopressin Acetate|
12060481|NCT00111189|Drug|Placebo|Placebo every 4 wk up to 24 mo
12060482|NCT00111189|Drug|Paliperidone Palmitate|25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
12060483|NCT00111176|Device|Endovascular repair|Endovascular repair.
12060484|NCT00111176|Procedure|Surgical|Surgical endovascular repair
12060485|NCT00111163|Drug|sulfadoxine-pyrimethamine with artesunate|
12060486|NCT00111163|Drug|amodiaquine with artesunate|
12060487|NCT00111163|Drug|chlorproguanil-dapsone|
12060488|NCT00111150|Drug|Tenofovir Disoproxil Fumarate 300 mg daily|
12060489|NCT00111137|Drug|rHuEPO|rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
12060490|NCT00111137|Drug|Darbepoetin alfa|4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
12060491|NCT00111124|Drug|Enbrel®|
12060492|NCT00111111|Drug|Etanercept|
12060493|NCT00111098|Drug|Darbepoetin Alfa|QM administration for 28 weeks, adjusted as necessary to maintain Hb between 11.0 - 13.0 g/dL PFS concentrations: 20, 30, 40, 50, 60, 80, 100, 150, 200 and 300 mcg.
12060494|NCT00111085|Drug|Clazosentan 1 mg/h|Subjects receive intravenous clazosentan at a rate of 1 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
12060495|NCT00111085|Drug|Clazosentan 5 mg/h|Subjects receive intravenous clazosentan at a rate of 5 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
12060496|NCT00111085|Drug|Clazosentan 15 mg/h|Subjects receive intravenous clazosentan at a rate of 15 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
12060497|NCT00111085|Drug|Placebo|Subjects receive intravenous placebo starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
12060498|NCT00111046|Drug|Ibuprofen|
12060499|NCT00111046|Drug|Tramadol|
12060500|NCT00111020|Drug|Sorafenib (Nexavar, BAY43-9006)|Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC
12060501|NCT00111007|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
12060502|NCT00111007|Drug|Carboplatin/Paclitaxel|Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
12060503|NCT00111007|Drug|Placebo|Placebo, 2 tablets bid Study Days 2-19
12060504|NCT00110994|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
12060505|NCT00110994|Drug|Placebo|Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
12060506|NCT00110994|Drug|Dacarbazine|Dacarbazine, 1000 mg/m^2 intravenous on Study Day 1
12060507|NCT00110981|Device|NB-UVB|Three times a week (TIW) for 12 weeks
12060508|NCT00110981|Drug|Etanerept|50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
12060509|NCT00110981|Drug|Etanercept|50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
12060510|NCT00110968|Drug|Itopride hydrochloride|
12060511|NCT00110955|Drug|Darbepoetin alfa|Q3W 300 mcg darbepoetin alfa
12060512|NCT00110955|Drug|Placebo|Q3W dosing of placebo
12060513|NCT00110942|Drug|Systemic AMG 108|300 mg SC AMG 108 Q4W for 3 doses
12060514|NCT00110942|Other|Placebo|SC placebo injection Q4W for 3 doses
12060515|NCT00110929|Drug|AMG 073|
12060516|NCT00110916|Drug|Intra-articular metHuIL-1ra (anakinra)|anakinra
12060517|NCT00110916|Drug|placebo|placebo
12060518|NCT00110903|Drug|Etanercept Liquid|
12060519|NCT00110890|Drug|cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.
12060520|NCT00110890|Other|Standard of care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
12060521|NCT00111072|Drug|dexamethasone 0.01% solution|
12060522|NCT00110877|Drug|LPV/rtv|One 400mg LPV tablet twice daily with 100mg RTV
12060523|NCT00110877|Drug|TMC114/rtv|Two 300mg TMC114 tablets twice daily with 100mg RTV
12060524|NCT00110864|Drug|PN2034|
12060525|NCT00110864|Drug|Insulin|
12060526|NCT00110851|Drug|rosiglitazone|
12060527|NCT00110851|Drug|metformin|
12060528|NCT00110851|Drug|PN2034|
12060529|NCT00110838|Procedure|Supplementation with fish oil versus placebo|
12060530|NCT00110825|Behavioral|Cognitive Behavior Therapy|extended treatment with cognitive behavior therapy
12060531|NCT00110812|Drug|IL-2|7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)
12060532|NCT00110799|Drug|SB497115|Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
12060533|NCT00110799|Other|Placebo|Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
12060534|NCT00110786|Biological|Ragweed MATAMPL|
12060576|NCT00110409|Behavioral|Standard Emergency Room Asthma Education|Participants will receive standard emergency room education about asthma.
12060535|NCT00110773|Drug|S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)|S-Caine Peel, composed of a 1:1 (w:w) eutectic mixture of 7% lidocaine and 7% tetracaine, applied topically. S-Caine Peel applied at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
12060536|NCT00110773|Drug|Placebo Peel|Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
12060537|NCT00110760|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel was composed of a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine and was applied topically. S-Caine Peel was applied with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
12060538|NCT00110760|Drug|Placebo Peel|Placebo Peel applied topically with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
12060539|NCT00110747|Drug|S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)|S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine was applied topically. A thin layer of the peel (approximately 1 mm in thickness) was applied and remained on the treatment area for 30 minutes (±2 minutes).
12060540|NCT00110747|Drug|Placebo Peel|Peel was applied topically. A thin layer of the peel (approximately 1 mm in thickness) was applied and remained on the treatment area for 30 minutes (±2 minutes).
12060541|NCT00110734|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|
12060542|NCT00110721|Drug|GM-CT-01 plus 5-Fluorouracil|Single use vials, combined regimen of GM-CT-01 / 5-Fluorouracil (280 mg/m2 /500 mg/m2) given for 4 consecutive days in a 28 day cycle until disease progression.
12060543|NCT00110708|Drug|Oralgam (human immunoglobulin)|
12060544|NCT00110695|Drug|Nanoparticle albumin bound paclitaxel followed by FEC|Nanoparticle albumin bound paclitaxel 100 mg/m2 IV for 30 minutes once weekly for 12 weeks followed by FEC (5-FU 500mg/m2 IV push; epirubicin 100 mg/m2 IV over 15 min. [or if given with trastuzumab 75 mg/m2 IV over 15 min.]; cyclophosphamide 500 mg/m2 IV over 30 min.) on Day 1 every 21 days
12060545|NCT00110682|Drug|Imiquimod used as an adjunct to cryotherapy|
12060546|NCT00110669|Drug|Prednisone|"Prednisone and dummy preparations for this study will be obtained from Frank's Pharmacy in Ocala, FL and will be supplied as a tablet containing 2.5mg, 5mg, 10mg, 20mg or 50mg Prednisone. Inactive dummy pills of similar look/taste will be supplied to maintain blinding."
12060547|NCT00110656|Other|Observations|This is a non-interventional study- only observational.
12060548|NCT00110643|Device|CoolTouch II laser|
12060549|NCT00110630|Behavioral|10-week smoking cessation group therapy combined with NicoDerm CQ|
12060550|NCT00110617|Drug|Deferasirox (ICL670)|Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
12060551|NCT00110617|Drug|Deferoxamine (DFO)|Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.
12060552|NCT00110604|Behavioral|folic acid (0.8 mg)|
12060553|NCT00110591|Drug|PRO 140|Monoclonal antibody to CCR5
12060554|NCT00110578|Procedure|Adoptive transfer of HIV-specific CD8+ T cells|
12060555|NCT00110578|Drug|Aldesleukin|
12060556|NCT00110565|Device|Pulsed magnetic field pad|
12060557|NCT00110552|Drug|Salvia officinalis (sage)|oral dosage
12060558|NCT00110539|Behavioral|Complementary and alternative medicine education|
12060559|NCT00110526|Genetic|Ad.hIL-12|Ad.hIL-12 intraprostatic injection IND
12060560|NCT00110513|Biological|Recombinant human antithrombin (rhAT)|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of recombinant human antithrombin (rhAT) that will target and maintain an AT activity that is > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at > 80% and < 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
12060561|NCT00110500|Genetic|hVEGF-A|
12060562|NCT00110487|Drug|ERB-041|
12060563|NCT00110474|Drug|Glucosamine sulfate|
12060564|NCT00110474|Drug|Acetaminophen|
12060565|NCT00110461|Drug|Aripiprazole|Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.
12060566|NCT00110461|Drug|Aripiprazole|Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.
12060567|NCT00110461|Drug|placebo|Placebo tablet
12060568|NCT00110448|Drug|Aspirin|Aspirin 81 mg or 100 mg per day
12060569|NCT00110448|Drug|No aspirin|No aspirin use
12060570|NCT00110435|Drug|MK0653A, ezetimibe (+) simvastatin|
12060571|NCT00110435|Drug|Duration of Treatment: 4 wk placebo run in then 6 wk active|
12060572|NCT00110435|Drug|Comparator: atorvastatin|
12060573|NCT00110422|Drug|Irbesartan|Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
12060574|NCT00110422|Drug|Hydrochlorothiazide|Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.
12060575|NCT00110409|Behavioral|Asthma Education in Adults|The intervention involves enhancing asthma education, asthma self-efficacy and asthma-related social support and is administered during a single in-person session in the ED (or hospital for admitted patients) followed by telephone reinforcement.
12060635|NCT00110058|Drug|imatinib mesylate|
12060636|NCT00110058|Drug|mycophenolate mofetil|
12060577|NCT00110396|Biological|Interferon-beta-1a FBS-free/HSA-free|Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
12060578|NCT00110383|Behavioral|School-Based Supervised Asthma Therapy|Child's inhaled steroid use supervised daily at school
12060579|NCT00110370|Drug|Lispro Mixture Therapy|
12060580|NCT00110370|Drug|Glargine Basal-Bolus Therapy|
12060581|NCT00110357|Drug|Cetuximab + Irinotecan|Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
12060582|NCT00110357|Drug|Cetuximab + Irinotecan|Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
12060583|NCT00110344|Drug|Nexavar (Sorafenib, BAY43-9006)|Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days. Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.
12060584|NCT00110344|Drug|Placebo|Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days. Cycle 2 and 3: see above (no placebo application)
12060585|NCT00110318|Procedure|Manual therapy and therapeutic exercise|
12060586|NCT00110318|Procedure|Corticosteroid injections|
12060587|NCT00110305|Drug|TMC278 25 mg|TMC278 25 mg tablet will be administered once daily.
12060588|NCT00110305|Drug|TMC278 75 mg|TMC278 75 mg (1 X 25 mg + 1 X 50 mg) tablets will be administered once daily.
12060589|NCT00110305|Drug|TMC278 150 mg|TMC278 150 mg (1 X 50 mg + 1 X 100 mg) tablets will be administered once daily.
12060590|NCT00110305|Drug|Efavirenz|Efavirenz 600 mg (1 x 600 mg tablet or 3 x 200 mg capsules, depending on formulation locally available) will be administered once daily.
12060591|NCT00110305|Drug|Non-nucleoside reverse transcriptase inhibitor (NRTIs)|Investigator selected 2 NRTIs: (1) Zidovudine and lamivudine (Combivir) and (2) tenofovir disoproxil fumarate and emtricitabine (Truvada) will be administered as per the package inserts, along with the TMC278 during the study period.
12060592|NCT00110292|Behavioral|Age-specific parenting newsletters and developmental toys|
12060593|NCT00110292|Behavioral|Parent-completed Ages & Stages Questionnaires|
12060594|NCT00110292|Behavioral|Clinic-based distribution of children's books|
12060595|NCT00110279|Biological|H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)|Live attenuated H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine
12060596|NCT00110266|Drug|Deferasirox|20 mg/kg/day over one year in patients with MDS
12060597|NCT00110253|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel is composed of a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine, which was applied topically. The S Caine Peel was applied at approximately 1 mm in thickness and remained on the treatment area for 30 or 60 minutes
12060598|NCT00110240|Drug|vildagliptin|
12060599|NCT00110227|Behavioral|12-week Tai Chi Program|24 tai chi sessions. 2 sessions/week for 12 weeks.
12060600|NCT00110227|Behavioral|12-week Education Program|24 Educational sessions. 2 sessions/week for 12 weeks.
12060601|NCT00110214|Drug|docetaxel|Given IV
12060602|NCT00110214|Other|placebo|Given IV
12060603|NCT00110214|Drug|prednisone|Given orally
12060604|NCT00110214|Biological|bevacizumab|Given IV
12060605|NCT00110214|Other|laboratory biomarker analysis|Correlative studies
12060606|NCT00110201|Drug|Nesiritide|
12060607|NCT00110188|Drug|ridaforolimus|
12060608|NCT00110162|Drug|antiandrogen therapy|
12060609|NCT00110162|Drug|releasing hormone agonist therapy|
12060610|NCT00110162|Procedure|orchiectomy|
12060611|NCT00110149|Biological|rituximab|
12060612|NCT00110149|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12060613|NCT00110136|Drug|St. John's Wort|St. John's Wort 300mg tablet three times per day
12060614|NCT00110123|Drug|fotemustine|
12060615|NCT00110123|Drug|isolated perfusion|
12060616|NCT00110110|Biological|filgrastim|Given after chemo cycle for 7 days or until neutrophil counts return to normal.
12060617|NCT00110110|Drug|Carboplatin|Given at 28 mg/kg/dose.
12060618|NCT00110110|Drug|Cyclosporine|Given at 33 mg/kg/dose
12060619|NCT00110110|Drug|Etoposide|Given at 12 mg/kg/dose
12060620|NCT00110110|Drug|vincristine sulfate|Given at 0.025 mg/kg/dose for the first cycle and 0.05 mg/kg/dose for subsequent cycles if first cycle well-tolerated
12060621|NCT00110110|Procedure|cryosurgery|Local application of extreme cold to destroy residual tumor.
12060622|NCT00110110|Procedure|laser therapy|Local and precise application of laser beams to destroy residual tumor.
12060623|NCT00110084|Drug|Gemcitabine|1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
12060624|NCT00110084|Drug|Paclitaxel protein-bound particles for injectable suspension (albumin-bound)|125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
12060625|NCT00110071|Drug|fludarabine phosphate|Given IV
12060626|NCT00110071|Procedure|peripheral blood stem cell transplantation|Undergo transplantation (infusion of autologous or syngeneic PBSC via central line)
12060627|NCT00110071|Radiation|iodine I 131 tositumomab|Given IV (dosimetric dose) or via central line (therapeutic dose)
12060628|NCT00110071|Other|laboratory biomarker analysis|Correlative studies
12060629|NCT00110071|Other|flow cytometry|Correlative studies
12060630|NCT00110071|Genetic|polymerase chain reaction|Correlative studies
12060631|NCT00110058|Biological|recombinant interferon alfa|
12060632|NCT00110058|Biological|therapeutic allogeneic lymphocytes|
12060633|NCT00110058|Drug|cyclosporine|
12060634|NCT00110058|Drug|fludarabine phosphate|
12060637|NCT00110058|Procedure|peripheral blood stem cell transplantation|
12060638|NCT00110058|Radiation|radiation therapy|
12060639|NCT00110045|Drug|caspofungin acetate|
12060640|NCT00110032|Drug|EF5|Given IV
12060641|NCT00110032|Procedure|conventional surgery|Undergo surgery
12060642|NCT00110032|Procedure|positron emission tomography|Undergo PET
12060643|NCT00110032|Radiation|fluorine F 18 EF5|Given IV
12060644|NCT00110032|Other|pharmacological study|Correlative studies
12060645|NCT00110019|Drug|Carboplatin|Given IV
12060646|NCT00110019|Other|Laboratory Biomarker Analysis|Correlative studies
12060647|NCT00110019|Drug|Paclitaxel|Given IV
12060648|NCT00110019|Other|Pharmacological Study|Correlative studies
12060649|NCT00110019|Other|Placebo|Given PO
12060650|NCT00110019|Drug|Sorafenib Tosylate|Given PO
12060651|NCT00110006|Biological|rituximab|Rituximab IV over 3-6 hours. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
12060652|NCT00110006|Drug|cyclophosphamide|Cyclophosphamide IV over 30 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
12060653|NCT00110006|Drug|doxorubicin hydrochloride|Doxorubicin IV over 5 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
12060654|NCT00110006|Drug|prednisone|Oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
12060655|NCT00110006|Drug|vincristine sulfate|Vincristine IV over 5 minutes on day 1. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
12060656|NCT00110006|Procedure|positron emission tomography|Beginning 1 hour after receiving fludeoxyglucose F 18, patients undergo whole-body positron emission tomography (PET) scanning. Patients undergo repeat ^18FDG-PET scanning between days 7-10 of course 1, between courses 3 and 4, and then at the completion of R-CHOP.
12060657|NCT00110006|Radiation|fludeoxyglucose F 18|Patients receive fludeoxyglucose F 18 (^18FDG) IV.
12060658|NCT00109993|Biological|alemtuzumab|alemtuzumab IV over 2 hours on days 4-6, 18, and 32
12060659|NCT00109993|Drug|methylprednisolone|methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
12060660|NCT00109993|Drug|tacrolimus|tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease
12060661|NCT00109967|Biological|rituximab|375 mg/m^2 Given IV
12060662|NCT00109967|Drug|temsirolimus|25 mg given IV
12060663|NCT00109954|Drug|cisplatin|
12060664|NCT00109954|Radiation|brachytherapy|
12060665|NCT00109954|Radiation|yttrium Y 90 glass microspheres|
12060666|NCT00109941|Biological|opioid growth factor|OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
12060667|NCT00109941|Biological|metenkephalin, OGF-opioid growth factor|OGF given in saline iv 250 ug/kg weekly
12060668|NCT00109928|Drug|cisplatin|
12060669|NCT00109928|Drug|etoposide|
12060670|NCT00109928|Drug|gemcitabine|
12060671|NCT00109928|Drug|methylprednisolone|
12060672|NCT00109889|Procedure|magnetic resonance imaging|magnetic resonance imaging (MRI)
12060673|NCT00109889|Procedure|positron emission tomography|positron emission tomography (PET)
12060674|NCT00109876|Procedure|Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation|Undergo RFA
12060675|NCT00109863|Biological|hu14.18-IL2 fusion protein|
12060676|NCT00109850|Biological|cetuximab|400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
12060677|NCT00109850|Drug|cisplatin|30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
12060678|NCT00109850|Drug|irinotecan hydrochloride|65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
12060679|NCT00109850|Radiation|radiation therapy|The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
12060680|NCT00109837|Biological|filgrastim|As needed per physician discretion
12060681|NCT00109837|Drug|cyclophosphamide|Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1
12060682|NCT00109837|Drug|cytarabine|Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13
12060683|NCT00109837|Drug|daunorubicin|Induction: 60 mg/m2/d; IV; days 1, 2, and 3
12060684|NCT00109837|Drug|dexamethasone|Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28
12060685|NCT00109837|Drug|doxorubicin|Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22
12060686|NCT00109837|Drug|leucovorin|For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC < 3,000
12060687|NCT00109837|Drug|mercaptopurine|Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs
12060688|NCT00109837|Drug|methotrexate|Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs
12060689|NCT00109837|Drug|mitoxantrone|Induction 2: 80 mg/m2; IV; day 3
12060690|NCT00109837|Drug|Asparaginase|Induction: 2,000 IU/m2; IM or IV; day 15
12060691|NCT00109837|Drug|prednisone|Induction: 60 mg/m2/d; PO or IV; days 1-35
12060692|NCT00109837|Drug|thioguanine|Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14
12060693|NCT00109837|Drug|vincristine|Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22
12060694|NCT00109837|Radiation|radiation therapy|For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.
12060695|NCT00109837|Drug|allopurinol|300 mg/d PO Days 1-7
12060696|NCT00109837|Drug|bactrim|1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone
12060697|NCT00109824|Drug|decitabine|Given IV
12060698|NCT00109824|Drug|valproic acid|Given PO
12060699|NCT00109824|Other|pharmacological study|Correlative studies
12060700|NCT00109824|Other|laboratory biomarker analysis|Correlative studies
12060701|NCT00109811|Biological|PSA:154-163(155L) peptide vaccine|Given subcutaneously
12060702|NCT00109811|Biological|incomplete Freund's adjuvant|Given subcutaneously
12060703|NCT00109811|Other|laboratory biomarker analysis|Correlative studies
12060704|NCT00109798|Drug|temozolomide|Patient will take drug on day 1-5 of 28 day schedule
12060705|NCT00109798|Drug|topotecan hydrochloride|Patient will have IV on days 2-6 on a 28-day schedule
12060706|NCT00109785|Procedure|positron emission tomography|
12060707|NCT00109785|Radiation|fludeoxyglucose F 18|
12060708|NCT00109785|Radiation|iodine I 124 iododeoxyuridine|
12060709|NCT00109772|Drug|lenalidomide|Two 5 mg capsules taken one time per day
12060710|NCT00109772|Drug|Placebo|Two placebo capsules taken one time per day
12060711|NCT00109759|Biological|RagweedMATAMPL|
12060712|NCT00109746|Dietary Supplement|chromium picolinate|HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
12060713|NCT00109733|Biological|recombinant human growth hormone|0.005 mg/kg/day for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
12060714|NCT00109733|Biological|recombinant human growth hormone|0.010 mg/kg/day for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
12060715|NCT00109720|Behavioral|Diabetes Self-Management Consultant|services of a Diabetes Self-Management Consultant
12060716|NCT00109720|Behavioral|Enhanced Usual Care Control Group|Usual care plus results of metabolic assessments obtained during the study
12060717|NCT00109707|Drug|Nilotinib|
12060718|NCT00109681|Drug|Iloprost Inhalation Solution (Ventavis)|
12060719|NCT00109668|Drug|beclomethasone dipropionate (QVAR)|
12060720|NCT00109655|Biological|Oncolytic adenovirus (serotype 5) - CG0070|Intravesical administration of CG0070 (in suspension) directly into the bladder
12060721|NCT00109629|Drug|VRC-HIVDNA016-00-VP|
12060722|NCT00109629|Drug|VRC-HIVADV014-00|
12060723|NCT00109616|Behavioral|Newborn skin cleansing with 0.25% chlorhexidine solution|
12060724|NCT00109616|Behavioral|Cleansing of umbilical cord with soap and water solution|
12060725|NCT00109616|Behavioral|Cleansing of umbilical cord with 4% chlorhexidine|
12060726|NCT00109603|Drug|Tenofovir disoproxil fumarate|
12060727|NCT00109590|Drug|Didanosine, enteric-coated|once daily
12060728|NCT00109590|Drug|Lopinavir/ritonavir|twice daily
12060729|NCT00109590|Drug|Nevirapine|single-dose at the onset of labor
12060730|NCT00109590|Drug|Zidovudine|twice daily
12060731|NCT00109577|Drug|MCN36 (nutritional supplement)|nutritional supplement
12060732|NCT00109577|Drug|Placebo|nutritional supplement
12060733|NCT00109564|Drug|ispronicline (nicotinic acetylcholine receptor agonist)|
12060734|NCT00109551|Drug|zinc sulphate dietary supplement|
12060735|NCT00109551|Drug|iron sulphate-folic acid dietary supplement|
12060736|NCT00109538|Drug|Lonafarnib|200 mg twice daily (BID, ie, approximately 12 hours apart with food), oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
12060737|NCT00109538|Other|Placebo|BID, oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
12060738|NCT00109512|Drug|NBI-56418 (GnRH antagonist)|
12060739|NCT00109512|Drug|placebo|
12060740|NCT00109499|Drug|AdGVPEDF.11D|
12060741|NCT00109486|Drug|GW685698X|
12060742|NCT00109473|Drug|growth hormone|Nutropin AQ 0.075mg/kg/day subcutaneously daily
12060743|NCT00109473|Drug|cortecosteroid|As prescribed by the referring gastroenterologist
12060744|NCT00109460|Behavioral|Tobacco Use Disorder|
12060745|NCT00109421|Behavioral|Project ÒRÉ|Community-based adolescent social network HIV/STI intervention tailored to African American culture
12060746|NCT00109408|Drug|Methotrexate|7.5-20mg po weekly
12060747|NCT00109408|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks
12060748|NCT00109395|Drug|Lorazepam|Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
12060749|NCT00109395|Drug|Midazolam|Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
12060750|NCT00109395|Drug|Lorazepam CI|Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
12060751|NCT00109382|Drug|Aspirin|
12060752|NCT00109382|Drug|Clopidogrel|
12060753|NCT00109382|Drug|Simvastatin|
12060754|NCT00109369|Other|Information and decision support for providers and patients|Laboratory-based decision support, reminders, and population report cards.
12060755|NCT00109356|Drug|AQ4N (Chemotherapy)|
12060756|NCT00109343|Biological|Comparator: ProQuad™ (V221)|0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
12060757|NCT00109343|Biological|Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)|0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
12060758|NCT00109330|Biological|Combined diphtheria, tetanus, acellular pertussis vaccine|
12060759|NCT00109317|Drug|Raptiva (efalizumab)|
12060760|NCT00109304|Biological|VEE 3526|
12060761|NCT00109291|Drug|Placebo|
12060762|NCT00109291|Drug|peginesatide|
12060763|NCT00109278|Biological|V205C, measles, mumps, and rubella virus vaccine live|
12060764|NCT00109278|Biological|Comparator: Measles, Mumps, and Rubella Virus Vaccine Live|
12060765|NCT00109265|Drug|Erlotinib HCl (OSI-774)|
12060766|NCT00109252|Drug|Raptiva (efalizumab)|
12060767|NCT00109239|Drug|rhuMAb VEGF (Bevacizumab)|
12060768|NCT00109226|Drug|Avastin (Bevacizumab)|
12061041|NCT00107185|Biological|therapeutic autologous dendritic cells|
12060769|NCT00109213|Procedure|Lumbar Laminectomy with Instrumented Pedicle Screw Fusion|Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine
12060770|NCT00109213|Procedure|Lumbar Laminectomy|Removal of bone to decompress spinal nerves
12060771|NCT00109200|Drug|Xolair (omalizumab)|
12060772|NCT00109187|Drug|Xolair (omalizumab)|
12060773|NCT00109174|Device|3T and 7T device|3T and 7T device
12060774|NCT00109161|Drug|Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)|
12060775|NCT00109148|Drug|MK0364|
12060776|NCT00109135|Drug|taranabant|
12060777|NCT00109122|Biological|zoster vaccine live (Oka/Merck)|
12060778|NCT00109122|Biological|Comparator: placebo (unspecified)|
12060779|NCT00109109|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months|
12060780|NCT00109096|Drug|Pemetrexed|
12060781|NCT00109083|Drug|RWJ-333369|
12060782|NCT00109070|Drug|Avastin (bevacizumab)|
12060783|NCT00109057|Drug|Avastin (bevacizumab)|
12060784|NCT00109044|Drug|Escitalopram|
12060785|NCT00109031|Drug|palifermin|Administered as one daily intravenous bolus.
12060786|NCT00109031|Radiation|Total Body Irradiation|To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
12060787|NCT00109031|Drug|Cyclophosphamide|Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
12060788|NCT00109031|Drug|Etoposide|Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
12060789|NCT00109031|Drug|Placebo|Administered as one daily intravenous bolus.
12060790|NCT00109005|Drug|Revlimid|oral dose (1 capsule) 25 mg per day 7 days a week for cohort 1 oral dose (1 capsule) 5 mg per day 7 days a week for cohort 2
12060791|NCT00108992|Drug|Diclofenac, topical|
12060792|NCT00108979|Drug|Escitalopram|
12060793|NCT00108953|Drug|Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin|Multi kinase inhibitor plus Chemotherapy
12060794|NCT00108953|Drug|Doxorubicin/Placebo|Chemotherapy plus Placebo
12060795|NCT00108927|Behavioral|TRANSLATE|
12060796|NCT00108914|Drug|GW685698X|
12060797|NCT00108901|Behavioral|Aerobic exercise program|Vigorous intermittent physical activity in group format conducted in research gymnasium after school by research staff. Heart rate monitors documented each child's average heart rate on a daily basis. Small incentives were offered for achieving goal of >150 bpm average HR each day and attending at least 80% of sessions (4 days/week).
12060798|NCT00108875|Biological|Survivin peptide vaccine|
12060799|NCT00108862|Other|Strategy: Immediate ART|The intervention is the strategy of initiating antiretroviral therapy (ART) after approximately 2 weeks of rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is efavirenz (EFV) 600 mg (1 tablet orally), emtricitabine (FTC) 200 mg (1 capsule orally), and tenofovir disoproxil fumarate (TDF) 300 mg (1 tablet orally) daily. Substitutions with other locally available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.
12060800|NCT00108862|Other|Strategy: Deferred ART|The intervention is the strategy of initiating ART either after 8-12 weeks of RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is EFV 600 mg (1 tablet orally), FTC 200 mg (1 capsule orally), and TDF 300 mg (1 tablet orally) daily. Initiation outside of these windows, on a case by case basis, is permitted at the discretion of the site investigator. Substitutions with other locally available U.S. FDA-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.
12060801|NCT00108849|Drug|estradiol, 10 mcg|
12060802|NCT00108836|Drug|XBD173|
12060803|NCT00108823|Drug|Roflumilast|
12060804|NCT00108810|Drug|Transdermal Ketoprofen Patch with CHADD|12 hours patch application for 28 days
12060805|NCT00108810|Drug|Placebo transdermal patch|12 hours application for 28 days
12060806|NCT00108797|Drug|eptacog alfa (activated)|
12060807|NCT00108797|Drug|Feiba VH|
12060808|NCT00108784|Behavioral|Reduced-energy-density diet|
12060809|NCT00108771|Drug|ZR-02-01 Fentanyl Transdermal Matrix Patch|Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period.
12060810|NCT00108771|Drug|Placebo Patch|Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period
12060811|NCT00108758|Drug|activated recombinant human factor VII|
12060812|NCT00108745|Other|Clinical Observation|Undergo observation
12060813|NCT00108745|Other|Laboratory Biomarker Analysis|Correlative studies
12060814|NCT00108745|Drug|Paclitaxel|Given IV
12060815|NCT00108745|Drug|Paclitaxel Poliglumex|Given IV
12060816|NCT00108745|Procedure|Quality-of-Life Assessment|Ancillary studies
12060817|NCT00108732|Drug|Bicalutamide|Given orally
12060818|NCT00108732|Drug|Goserelin Acetate|Given SC
12060819|NCT00108732|Biological|Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine|Given SC
12060820|NCT00108732|Biological|Recombinant Vaccinia-TRICOM Vaccine|Given SC
12060821|NCT00108732|Biological|Sargramostim|Given SC
12060822|NCT00108706|Drug|Candesartan|
12060823|NCT00108667|Drug|IV Levodopa|
12060824|NCT00108667|Drug|Talampanel|
12060825|NCT00108654|Drug|VRC-HIVADV014-00-VP|
12060964|NCT00107627|Other|Caprosyn subcuticular sutures.|Caprosyn subcuticular sutures.
12060965|NCT00107627|Other|Monocryl subcuticular sutures.|Monocryl subcuticular sutures.
12061042|NCT00107172|Procedure|surgery|
12060826|NCT00108628|Behavioral|Imagery Rehearsal|IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
12060827|NCT00108628|Behavioral|Sleep and Nightmare Management|This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
12060828|NCT00108615|Drug|Metformin|
12060829|NCT00108615|Drug|Pioglitazone|
12060830|NCT00108615|Drug|Metformin|
12060831|NCT00108615|Drug|Pioglitazone|
12060832|NCT00108615|Radiation|CT scans|To measure changes in adipose tissue volumes
12060833|NCT00108615|Procedure|Oral glucose tolerance test|To detect a change in glucose tolerance
12060834|NCT00108602|Drug|acetazolamide|
12060835|NCT00108589|Drug|S-adenosylmethionine|
12060836|NCT00108576|Drug|Divalproex|anticonvulsant; mood stabilizer
12060837|NCT00108576|Other|placebo|Look-a-like placebo
12060838|NCT00108563|Drug|Citalopram or Placebo|
12060839|NCT00108550|Drug|gabapentin|Gabapentin 300m on Day 1, with daily or weekly increase to 3600 mg (maximum) by mouth by Week 5 of the 12-week trial
12060840|NCT00108550|Drug|Inert placebo|Inactive placebo capsule, one capsule on Day 1 with daily or weekly increase to 9 capsules daily by Week 5 of the 12-week trial
12060841|NCT00108537|Drug|bupropion and transdermal patch|
12060842|NCT00108537|Drug|transdermal patch and nicotine inhaler|
12060843|NCT00108524|Behavioral|Low carbohydrate ketogenic diet|A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
12060844|NCT00108524|Drug|Orlistat|In addition to the low fat diet, Orlistat is taken 3 times daily.
12060845|NCT00108524|Behavioral|Low-fat diet|Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake
12060846|NCT00108511|Drug|Gemfibrozil|
12060847|NCT00108498|Drug|mirtazapine|
12060848|NCT00108485|Drug|Extended release niacin|Extended release niacin 1500-2000mg once daily
12060849|NCT00108485|Other|Placebo|Placebo tablets
12060850|NCT00108459|Behavioral|Low Carbohydrate Diet|
12060851|NCT00108446|Drug|dextromethorphan|
12060852|NCT00108446|Drug|naloxone|
12060853|NCT00108446|Drug|fentanyl|
12060854|NCT00108446|Drug|lidocaine|
12060855|NCT00108433|Drug|Cefazolin IV|
12060856|NCT00108433|Drug|Linezolid IV|
12060857|NCT00108433|Drug|Vancomycin (IV)|
12060858|NCT00108420|Drug|Prazosin|
12060859|NCT00108407|Behavioral|Integrated Cognitive Behavioral Therapy|
12060860|NCT00108407|Behavioral|Twelve Step Facilitation Therapy|
12060861|NCT00108394|Drug|pamidronate|
12060862|NCT00108381|Behavioral|tailored cognitive behavior therapy|tailored psychological treatment
12060863|NCT00108381|Behavioral|standard care|standard psychological treatment
12060864|NCT00108368|Drug|Risperidone|
12060865|NCT00108368|Drug|Olanzapine|
12060866|NCT00108355|Drug|Albumin|Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed
12060867|NCT00108355|Drug|Intravenous Saline Infusion (Albumin placebo)|Intravenous saline Infusion (Albumin placebo)
12060868|NCT00108355|Drug|Midodrine|Midodrine oral tablet at 10 mg three times a day.
12060869|NCT00108355|Drug|Oral tablet (Midodrine placebo)|Oral tablet (Midodrine placebo) three times a day
12060870|NCT00108355|Drug|Octreotide LAR|Octreotide LAR 20 mg intramuscular injection every 30 days
12060871|NCT00108355|Drug|Saline injection (Octreotide LAR placebo)|Saline intramuscular injection 5 cc every 30 days.
12060872|NCT00108355|Procedure|Large Volume Paracentesis|Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.
12060873|NCT00108342|Drug|Nicotine gum - 2 mg and 4 mg|
12060874|NCT00108342|Drug|Nicotine lozenges - 2 mg and 4 mg|
12060875|NCT00108342|Drug|"Nicotine inhaler (4 mg yield) - low and high dosage by frequency of puffing"|can yield 4 mg from 10 mg device - infrequent and frequent puffing
12060876|NCT00108342|Other|Computer learning|
12060877|NCT00108329|Behavioral|Weight Loss|
12060878|NCT00108316|Drug|Fluoxetine (Liquid Prozac)|
12060879|NCT00108303|Other|Diagnostic|Diagnostic evaluation for schizophrenia. Schizophrenia includes schizophrenia and schizoaffective disorder.
12060880|NCT00108290|Drug|Chemotherapy|
12060881|NCT00108277|Behavioral|Breathing Training-Raise CO2|while breathing 9 breaths per minute, patients are instructed to raise CO2
12060882|NCT00108277|Behavioral|Breathing Training- Lower CO2|while breathing 9 breaths per minute, patients are instructed to lower CO2
12060883|NCT00108264|Biological|Tumor RNA transfected dendritic cells|
12060884|NCT00108251|Drug|Eplerenone|aldosterone receptor blocker
12060885|NCT00108251|Drug|Placebo|matching placebo
12060886|NCT00108238|Drug|Estradiol followed by progesterone|
12060887|NCT00108238|Drug|Raloxifene|
12060888|NCT00108225|Other|LoBag Diet - test phase|A Low Biologically Available Glucose (LOBAG30), weight maintaining diet consisting of 30% carbohydrate, 30% protein, 40% fat will be provided to subjects for 5 weeks.
12060889|NCT00108225|Other|LoBAG Diet - control phase|A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks
12060890|NCT00108212|Behavioral|Diet|
12060891|NCT00108199|Behavioral|Problem-Solving Training|
12060892|NCT00108199|Behavioral|Work-Related Social Skills Training|
12060963|NCT00107640|Behavioral|Patient-provider education|Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.
12060893|NCT00108186|Drug|Celecoxib|Eight subjects will be assigned to one of three cohorts. Subjects will receive Celecoxib in escalating doses per cohort, starting with 200mg twice a day by mouth; 400mg twice a day by mouth; and increasing to 600mg twice a day by mouth, for a total of 7 days. Subjects will have blood taken before the start of Celecoxib, and after completion of 7-days of Celecoxib.
12060894|NCT00108173|Drug|Zyban|
12060895|NCT00108160|Drug|Mupirocin Ointment [Treatment]|The impact of the treatment arm versus placebo arm on development of new (recurrent) S. aureus infection will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.
12060896|NCT00108160|Drug|Polyethylene Glycol Ointment [Placebo]|The impact of the treatment arm versus placebo arm on development of S. aureus re-infections will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.
12060897|NCT00108147|Procedure|Circuit Training|
12060898|NCT00108147|Procedure|Cardiac Rehabilitation|
12060899|NCT00108147|Procedure|Flexibility and toning|
12060900|NCT00108134|Drug|PEP005|
12060901|NCT00108121|Drug|PEP005|
12060902|NCT00108108|Drug|HCD122|
12060903|NCT00108095|Drug|intravenous ondansetron|
12060904|NCT00108082|Drug|carvedilol MR|Study drug
12060905|NCT00108082|Drug|atenolol|Comparator
12060906|NCT00108082|Drug|lisinopril|Comparator
12060907|NCT00108069|Drug|Tamoxifen citrate|oral dose 120 mg twice a day, every day
12060908|NCT00108069|Drug|Bortezomib|intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
12060909|NCT00108056|Drug|Enzastaurin (LY317615) monohydronchloride|
12060910|NCT00108043|Procedure|FES-evoked functional upright gait|
12060911|NCT00108030|Procedure|Partial Body-weight supported Treadmill Training|
12060912|NCT00108030|Procedure|PBWST + Power training|
12060913|NCT00108030|Procedure|"Usual physiotherapy care"|
12060914|NCT00108017|Drug|MK0507A, dorzolamide hydrochloride (+) timolol maleate|
12060915|NCT00108017|Drug|Comparator: timolol maleate|
12060916|NCT00108017|Drug|Duration of Treatment: Part 1) 6 wk timolol maleate run in|
12060917|NCT00108017|Drug|Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds|
12060918|NCT00108004|Drug|pramlintide acetate|Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.
12060919|NCT00107991|Drug|etanercept|etanercept 50 mg/week subcutaneous injection
12060920|NCT00107978|Drug|Telavancin|Telavancin 10 mg/kg/day, IV for up to 14 days.
12060921|NCT00107978|Drug|Vancomycin|Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
12060922|NCT00107965|Drug|PEP005|0.0025% PEP005 Topical Gel (Day 1,2 application)
12060923|NCT00107965|Drug|PEP005|0.01% PEP005 Topical Gel (Day 1,2 application)
12060924|NCT00107965|Drug|PEP005|0.05% PEP005 Topical Gel (Day 1,2 application)
12060925|NCT00107965|Drug|PEP005|Vehicle Gel (Day 1,2 application)
12060926|NCT00107965|Drug|PEP005|0.0025% PEP005 Topical Gel (Day 1,8 application)
12060927|NCT00107965|Drug|PEP005|0.01% PEP005 Topical Gel (Day 1,8 application)
12060928|NCT00107965|Drug|PEP005|0.05% PEP005 Topical Gel (Day 1,8 application)
12060929|NCT00107965|Drug|PEP005|Vehicle Gel (Day 1,8 application)
12060930|NCT00107952|Drug|Telavancin|Telavancin 10 mg/kg/day IV for up to 21 days.
12060931|NCT00107952|Drug|Vancomycin|Vancomycin 1 Gm IV q 12 hrs for up to 21 days
12060932|NCT00107939|Drug|Licarbazepine|
12060933|NCT00107926|Drug|Licarbazepine|
12060934|NCT00107926|Drug|Placebo|
12060935|NCT00107913|Drug|Doxil|
12060936|NCT00107900|Drug|DU-176b|
12060937|NCT00107887|Drug|INH preventive therapy|Clinics will receive training regarding the use of IPT for prevention of Tuberculosis
12060938|NCT00107887|Drug|TST (tuberculin skin test)|Clinics will be trained in the use of TST for assessing exposure to TB
12060939|NCT00107874|Drug|misoprostol|
12060940|NCT00107861|Drug|Ad.hIFN-β (BG00001, IDEC-201)|
12060941|NCT00107848|Drug|Modafinil|
12060942|NCT00107835|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine was applied topically. The study drug remained on the treatment area for 20-30 minutes for minor dermal procedures and 60 minutes for major dermal procedures
12060943|NCT00107822|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|
12060944|NCT00107809|Drug|Modafinil|
12060945|NCT00107796|Drug|Modafinil|
12060946|NCT00107783|Drug|Nitisinone (NTBC)|Treatment
12060947|NCT00107770|Drug|sodium phenylbutyrate|histone deacteylase inhibitor
12060948|NCT00107757|Drug|GW685698X|
12060949|NCT00107744|Dietary Supplement|Soy protein-milk protein-carbohydrate|40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks
12060950|NCT00107744|Dietary Supplement|Milk protein-carbohydrate-soy protein|40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.
12060951|NCT00107744|Dietary Supplement|Carbohydrate-soy protein-milk protein|40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks.
12060952|NCT00107731|Drug|quetiapine fumarate|
12060953|NCT00107731|Drug|lithium|
12060954|NCT00107731|Drug|divalproex|
12060955|NCT00107718|Drug|SB-485232|
12060956|NCT00107705|Biological|Tree MATA MPL|
12060957|NCT00107692|Behavioral|Physical activity and diet|
12060958|NCT00107666|Drug|CTI-01 (ethyl pyruvate)|
12060959|NCT00107653|Drug|Ribavirin|1000-1200mg po daily for 48 weeks
12060960|NCT00107653|Drug|Peginterferon alfa-2a|180 micrograms sc/week for 48 weeks
12060961|NCT00107653|Drug|Ribavirin|1000-1200mg po daily for 48 weeks
12060962|NCT00107653|Drug|Peginterferon alfa-2a|180 micrograms sc/week for 48 weeks
12060966|NCT00107627|Other|Skin staples;|Skin staples;
12060967|NCT00107614|Drug|DT PACE + Rituxan|INDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with < 50% response to induction) OR MEL-DT PACE (Patients with > 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive or proliferative disease, will receive BEAM) MAINTENANCE PHASE Rituxan every 3 months x 1 year
12060968|NCT00107601|Drug|Insulin|
12060969|NCT00107588|Behavioral|Reinforcement for homework completion|Provides contingent reinforcement for engaging in homework activities designed to enhance coping skills
12060970|NCT00107588|Behavioral|Reinforcement for Abstinence|Provides contingent reinforcement for submitting marijuana-free urine specimen
12060971|NCT00107588|Behavioral|Case Management|Will control for the effect of therapist-client contact by providing supportive case management as an active control condition.
12060972|NCT00107575|Behavioral|Standard treatment plus brief alcohol intervention|Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention
12060973|NCT00107575|Other|Standard treatment (ST)|Behavioral smoking cessation counseling and nicotine patch.
12060974|NCT00107562|Behavioral|Adolescent Safer Sex Social Network Intervention|
12060975|NCT00107549|Biological|rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])|Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4
12060976|NCT00107549|Biological|rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])|Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
12060977|NCT00107536|Drug|lapatinib ditosylate|
12060978|NCT00107536|Other|laboratory biomarker analysis|Correlative studies
12060979|NCT00107523|Drug|cytarabine|
12060980|NCT00107523|Drug|idarubicin|
12060981|NCT00107523|Drug|pravastatin|
12060982|NCT00107510|Biological|pegfilgrastim|
12060983|NCT00107510|Drug|carboplatin|
12060984|NCT00107510|Drug|docetaxel|
12060985|NCT00107510|Procedure|conventional surgery|
12060986|NCT00107497|Radiation|Radiation therapy|
12060987|NCT00107484|Drug|ferumoxtran-10|
12060988|NCT00107484|Procedure|magnetic resonance imaging|
12060989|NCT00107484|Procedure|sentinel lymph node biopsy|
12060990|NCT00107471|Biological|filgrastim|Given PO
12060991|NCT00107471|Drug|topotecan hydrochloride|Given IV
12060992|NCT00107471|Radiation|radiation therapy|
12060993|NCT00107458|Drug|valproic acid|
12060994|NCT00107445|Drug|EF5|Given IV
12060995|NCT00107432|Drug|sorafenib tosylate|Given orally
12060996|NCT00107432|Other|laboratory biomarker analysis|Correlative studies
12060997|NCT00107419|Drug|pemetrexed disodium|pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
12060998|NCT00107393|Biological|trastuzumab|
12060999|NCT00107393|Drug|capecitabine|
12061000|NCT00107380|Biological|rituximab|
12061001|NCT00107380|Drug|cyclophosphamide|
12061002|NCT00107380|Drug|doxorubicin hydrochloride|
12061003|NCT00107380|Drug|prednisone|
12061004|NCT00107380|Drug|vincristine sulfate|
12061005|NCT00107380|Radiation|tositumomab and iodine I 131 tositumomab|
12061006|NCT00107367|Procedure|conventional surgery|
12061007|NCT00107367|Radiation|intraoperative radiation therapy|
12061008|NCT00107354|Biological|aldesleukin|
12061009|NCT00107354|Biological|therapeutic allogeneic lymphocytes|
12061010|NCT00107354|Biological|therapeutic autologous lymphocytes|
12061011|NCT00107354|Drug|cytarabine|
12061012|NCT00107354|Drug|etoposide|
12061013|NCT00107354|Drug|mitoxantrone hydrochloride|
12061014|NCT00107354|Procedure|allogeneic bone marrow transplantation|
12061015|NCT00107354|Procedure|peripheral blood stem cell transplantation|
12061016|NCT00107341|Drug|bortezomib|
12061017|NCT00107341|Drug|carboplatin|
12061018|NCT00107341|Drug|paclitaxel|
12061019|NCT00107315|Biological|bevacizumab|
12061020|NCT00107315|Drug|capecitabine|
12061021|NCT00107289|Radiation|iobenguane I 131|"Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes to 4 hours on day 0. Patients undergo radiation dosimetry following the first dose of ^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) 6-8 weeks after the first dose if response is achieved and patients do not experience major toxicity. After blood radioactivity has fallen below 1 μCi/mL, patients may undergo autologous stem cell transplantation.
~After completion of study treatment, patients are followed at 4-6 weeks after ^131I-MIBG administration and then every 3 months for up to 1 year."
12061022|NCT00107276|Drug|capecitabine|
12061023|NCT00107276|Drug|cyclophosphamide|
12061024|NCT00107263|Drug|letrozole|
12061025|NCT00107263|Drug|zoledronic acid|
12061026|NCT00107250|Drug|capecitabine|1000 mg/m2 orally twice daily (total of 2000 mg/m2 per day) for the first 14 days of a 21 day cycle for a maximum of 6-8 cycles.
12061027|NCT00107250|Drug|carboplatin|AUC 6; IV; 30 minutes; Every 21 days for a maximum of 6-8 cycles
12061028|NCT00107250|Drug|cediranib maleate|Given daily; orally with approximately 240 ml of water whilst in an upright position
12061029|NCT00107250|Drug|paclitaxel|200mg/m2; IV; 3 hours; Every 21 days for a maximum of 6-8 cycles
12061030|NCT00107237|Drug|AEE788|AEE788 was available in the form of a hard gelatin capsule of 50 mg or 100 mg strengths and packaged in bottles.
12061031|NCT00107237|Drug|everolimus|Everolimus was formulated as tablets of 2.5 mg and 5 mg strength and supplied in blister packs.
12061032|NCT00107211|Biological|therapeutic autologous dendritic cells|
12061033|NCT00107211|Procedure|conventional surgery|
12061034|NCT00107211|Procedure|neoadjuvant therapy|
12061035|NCT00107198|Drug|doxorubicin hydrochloride|Given IV
12061036|NCT00107198|Procedure|conventional surgery|Undergo surgery
12061037|NCT00107198|Drug|cyclophosphamide|Given IV
12061038|NCT00107198|Drug|prednisone|Given IV or PO
12061039|NCT00107198|Drug|vincristine sulfate|Given IV
12061040|NCT00107198|Radiation|radiation therapy|Undergo IFRT
12061044|NCT00107159|Biological|autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine|
12061045|NCT00107120|Drug|Escitalopram|Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
12061046|NCT00107120|Drug|Placebo|Placebo once daily for up to 8 weeks
12061047|NCT00107107|Drug|pramlintide acetate|Syringe vial and Pen-cartridge
12061048|NCT00107094|Drug|Abraxane|
12061049|NCT00107081|Drug|ciprofloxacin and amoxicillin|
12061050|NCT00107081|Procedure|Outpatient management|
12061051|NCT00107081|Drug|i.v. antibiotics|
12061052|NCT00107081|Procedure|inpatient management|
12061053|NCT00107068|Procedure|[A] Aerobic isokinetic cycling exercise|
12061054|NCT00107068|Procedure|[B] Progressive Resistance Training|
12061055|NCT00107068|Procedure|[A] + [B]|
12061056|NCT00107055|Drug|REN-1654|
12061057|NCT00107042|Biological|Recombivax|Participants receive doses of Recombivax at weeks 0 and 24.
12061058|NCT00107042|Biological|Twinrix|Participants receive doses of Twinrix at weeks 0 and 24.
12061059|NCT00107016|Drug|RAD001, Letrozole 2.5mg|
12061060|NCT00107016|Drug|Letrozole 2.5mg|
12061061|NCT00107003|Drug|lapatinib ditosylate|
12061062|NCT00107003|Procedure|Adjuvant therapy|
12061063|NCT00107003|Procedure|Conventional surgery|
12061064|NCT00107003|Procedure|Neoadjuvant therapy|
12061065|NCT00106964|Biological|Engerix-B 20 mcg|A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.
12061066|NCT00106964|Biological|Engerix-B 40 mcg|A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.
12061067|NCT00106964|Biological|Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg|"Arm 3: 720 EIA HAV Ag, 20 mcg HBsAg/ml:
~A single dose of 1 mL will be administered in the deltoid muscle."
12061068|NCT00106938|Device|Carotid artery stenting with filter (interventional)|Carotid artery stenting with filter (interventional)
12061069|NCT00106938|Procedure|Carotid artery endarterectomy (surgical)|Carotid artery endarterectomy (surgical)
12061070|NCT00106899|Procedure|Magnetic Resonance Imaging (MRI)|MRI scans
12061071|NCT00106899|Procedure|Positron Emission Tomography (PET)|PET scans
12061072|NCT00106899|Procedure|Lumbar Puncture (LP)|collection of cerebrospinal fluid
12061073|NCT00106886|Drug|Folic acid, vitamin B6 and B12 or placebo|
12061074|NCT00106860|Drug|a benzodiazepine drug|
12061075|NCT00106847|Drug|Infliximab|
12061076|NCT00106834|Drug|Infliximab|
12061077|NCT00106821|Drug|Tiotropium Bromide Inhalation Powder|
12061078|NCT00106808|Drug|Muraglitazar|
12061079|NCT00106808|Drug|Pioglitazone|
12061080|NCT00106782|Procedure|Transcranial Electrical Polarization (TEP)|
12061081|NCT00106769|Drug|VRC-WNVDNA017-00-VP|
12061082|NCT00106717|Procedure|Narrative medicine|
12061083|NCT00106704|Drug|Comparator: Sitagliptin|sitagliptin 10 mg tablet, once daily for 54 weeks
12061084|NCT00106704|Drug|Comparator: Placebo|Placebo oral tablet once daily for 24 weeks
12061085|NCT00106704|Drug|Comparator: Pioglitazone|Pioglitazone 30 mg tablet once daily for 30 weeks
12061086|NCT00106691|Drug|Toremifene 20 mg|20 mg once a day
12061087|NCT00106691|Drug|Placebo|placebo tablet identically appearing to the toremifene 20 mg tablet, administered daily for 360 days.
12061088|NCT00106639|Drug|CP-690,550|15 mg twice daily
12061089|NCT00106639|Drug|CP-690,550|30 mg twice daily
12061090|NCT00106639|Drug|tacrolimus|dose adjusted according to level
12061091|NCT00106626|Drug|vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin|Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).
12061092|NCT00106613|Drug|FK228 (romidepsin)|Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
12061093|NCT00106600|Drug|Pixantrone IV infusion|
12061094|NCT00106587|Device|paclitaxel coated balloon catheter (device with drug)|
12061095|NCT00106574|Drug|Placebo|iv every 4 weeks
12061096|NCT00106574|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks
12061097|NCT00106561|Drug|Spironolactone|
12061098|NCT00106561|Drug|Irbesartan|
12061099|NCT00106548|Drug|tocilizumab [RoActemra/Actemra]|4mg/kg iv / month
12061100|NCT00106548|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv / month
12061101|NCT00106548|Drug|Placebo|iv / month
12061102|NCT00106548|Drug|Methotrexate|10-25mg/week
12061103|NCT00106535|Drug|tocilizumab [RoActemra/Actemra]|4 mg/kg or 8 mg/kg IV/month every 4 weeks.
12061104|NCT00106535|Drug|Placebo|IV/month
12061105|NCT00106535|Drug|Methotrexate|10-25 mg/week
12061106|NCT00106522|Drug|Methotrexate|10-25mg weekly
12061107|NCT00106522|Drug|Placebo|iv every 4 weeks
12061108|NCT00106522|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks
12061109|NCT00106522|Drug|tocilizumab [RoActemra/Actemra]|4mg/kg iv every 4 weeks
12061110|NCT00106509|Drug|tolevamer potassium-sodium (GT267-004)|
12061111|NCT00106496|Drug|Protopic|topical
12061112|NCT00106496|Drug|Corticosteroid|topical
12061113|NCT00106496|Drug|placebo|topical
12061114|NCT00106431|Drug|romidepsin (depsipeptide, FK228)|Study patients received romidepsin at a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although patients who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
12061115|NCT00106418|Drug|Romidepsin|13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
12061116|NCT00106405|Drug|Memantine HCl|
12061117|NCT00106392|Drug|Tacrolimus|oral
12061118|NCT00106392|Drug|Placebo|oral
12061119|NCT00106379|Drug|Truvada (tenofovir DF + emtricitabine)|
12061120|NCT00106379|Drug|Emtriva (emtricitabine)|
12061121|NCT00106379|Drug|Viread (tenofovir DF)|
12061125|NCT00106353|Drug|Torisel|60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.
12061126|NCT00106340|Drug|vildagliptin|
12061127|NCT00106340|Drug|glimepiride|
12061128|NCT00106340|Drug|Metformin|
12061129|NCT00106340|Drug|Vildagliptin matching placebo|
12061130|NCT00106340|Drug|Glimepiride matching placebo|
12061131|NCT00106327|Behavioral|Exercise|6 months of supervised treadmill exercise or strength training, three times per week, followed by a 6 month home-based program.
12061132|NCT00106327|Behavioral|Diet|11 nutrition education sessions
12061133|NCT00106314|Drug|Dehydroepiandrosterone [DHEA]|
12061134|NCT00106301|Drug|FK228 (romidepsin)|Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
12061135|NCT00106288|Drug|Micafungin|IV
12061136|NCT00106288|Drug|Liposomal Amphotericin B|IV
12061137|NCT00106275|Behavioral|Mindfulness Based Stress Reduction|
12061138|NCT00106262|Drug|Velcade (bortezomib)|
12061139|NCT00106262|Drug|Irinotecan|
12061140|NCT00106249|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.
12061141|NCT00106249|Device|Sham|Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.
12061142|NCT00106236|Behavioral|exercise|
12061143|NCT00106223|Behavioral|Cognitive behavioral therapy (CBT)|Participants will receive a total of 22 sessions of individual, manual-based CBT. The CBT sessions will occur weekly during the course of the study. During the sessions, participants will receive education about BDD and CBT, engage in activities that help them confront their BDD, learn new ways of thinking about body image, and learn relapse prevention techniques.
12061144|NCT00106210|Behavioral|Early intervention blending several tx approaches, w/ focus|Early intervention blending several different treatment approaches, with a focus on certain skills
12061145|NCT00106210|Behavioral|Early intervention blending several treatment approaches|Early intervention blending several different treatment approaches
12061146|NCT00106197|Drug|Bupropion|Participants will start with 150 mg daily. If no adverse symptoms, dosage will be increased to twice daily. Treatment will last for 8 weeks.
12061147|NCT00106184|Drug|Rituximab|Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Group B - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum does of 1 gram at Weeks 8 and 9
12061148|NCT00106184|Drug|Placebo|"Treatment Group A: placebo infusion at Weeks 8 and 9
~Treatment Group B: placebo infusion at Weeks 0 and 1"
12061149|NCT00106171|Drug|Highly active antiretroviral therapy (HAART)|Regimens will be assigned by investigators
12061150|NCT00106158|Biological|protein vaccination|
12061151|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor|Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule.
12061152|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 450 mg|Dose 450 mg capsules daily for 28 day cycles.
12061153|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off|Dose escalating in a repeating intermittent dosing schedule of 3 days on and 4 days off at rising dose levels of 450, 600, 800, 1000, 1200, and 1400 mg/day.
12061154|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off|Dose escalating in a repeating intermittent dosing schedule of 1 day on/6 days off at rising dose levels of 600, 900, 1200, 1500, 1800, 2400, 3200 mg/day once weekly and then increase at 33% increments.
12061155|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg|Dose 350 mg capsules daily intermittent 3 days on/4 days off dosing. THIS DOSING SCHEDULE IS NO LONGER UNDER INVESTIGATION
12061156|NCT00106132|Drug|Triamcinolone Acetonide|
12061157|NCT00106119|Drug|Liothyronine and Levothyroxine|Hypothyroid patients are treated with Liothyronine and Levothyroxine in 2 crossover, randomized phases
12061158|NCT00106106|Procedure|NMR-spectroscopy|Scans were performed on a 3T scanner using the echo-time-averaged PRESS sequence previously published to detect glutamate's resonance line at 2.35 ppm and average out the interferences from glutamine, NAA and the macromolecules.
12061159|NCT00106106|Drug|Oral acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
12061160|NCT00106080|Behavioral|Audit and Feedback|Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.
12061161|NCT00106067|Behavioral|coping and communication support (CCS) intervention|"Trained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise.
~The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families."
12061162|NCT00106054|Drug|Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.|
12061163|NCT00106041|Behavioral|Veterans Integrated Palliative Care Nurse Case Manager|Palliative Care nurse case management
12061164|NCT00106028|Drug|risedronate sodium (Actonel)|risedronate tablet once a day for one year followed by risedronate once a day for two years
12061370|NCT00104481|Behavioral|cognitive behavior therapy|
12061165|NCT00106028|Drug|Placebo|placebo tablet once a day for one year followed by risedronate once a day for two years
12061166|NCT00106002|Drug|pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
12061167|NCT00105989|Drug|Duloxetine|
12061168|NCT00105989|Drug|placebo|
12061169|NCT00105976|Drug|MM-093|
12061170|NCT00105963|Behavioral|Education about infant crying|
12061171|NCT00105950|Drug|lapatinib|Tyrosine kinase inhibitor administered daily at 1500 mg/kg
12061172|NCT00105937|Drug|OraVescent fentanyl citrate|
12061173|NCT00105911|Behavioral|Cognitive Behavioral Therapy|
12061174|NCT00105898|Procedure|Web-based care management|Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters
12061175|NCT00105898|Procedure|Telephone and face-to-face care management|Participants interact with a care manager via face-to-face and telephone contact
12061176|NCT00105898|Procedure|Internet access alone|Participants are given internet access and encouraged to seek diabetes information to help in their self management
12061177|NCT00105885|Procedure|telephone care|Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinical visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval.
12061178|NCT00105872|Behavioral|Cognitive-Behavioral Therapy|
12061179|NCT00105859|Behavioral|Education and Counseling|
12061180|NCT00105846|Procedure|Home care telemedicine|
12061181|NCT00105833|Behavioral|Collaborative Care - Depression Decision Support (DDS)|Multifaceted collaborative intervention for depression based in primary care
12061182|NCT00105820|Procedure|System level depression care quality improvement|
12061183|NCT00105807|Behavioral|participation in low intensity exercise|
12061184|NCT00105807|Behavioral|participation in art and music activities|
12061185|NCT00105794|Procedure|Psychiatric Advance Directives intervention|
12061186|NCT00105781|Behavioral|Exercise counseling|
12061187|NCT00105768|Behavioral|Advisor-Teller Money Management-Substance Abuse Counselling|
12061188|NCT00105755|Device|personal dermal thermometer (DT)|
12061189|NCT00105755|Device|Device|
12061190|NCT00105742|Procedure|Diagnosis|
12061191|NCT00105729|Behavioral|Intensive referral to 12-step self-help groups|
12061192|NCT00105716|Behavioral|Telephone behavioral education|
12061193|NCT00105716|Behavioral|Computer behavioral education|
12061194|NCT00105703|Behavioral|Case management using advanced nurse practitioners|
12061195|NCT00105690|Behavioral|Telemedicine intervention|
12061196|NCT00105664|Procedure|Collaborative care model|
12061197|NCT00105664|Procedure|Group interventions|
12061198|NCT00105664|Procedure|Facilitated consultation|
12061199|NCT00105651|Behavioral|Combined nursing invention|
12061200|NCT00105638|Behavioral|educational program, by telephone|
12061201|NCT00105612|Device|Memory and Organizational Aid|
12061202|NCT00105612|Behavioral|Standard Informed Consent Process|The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home
12061203|NCT00105599|Behavioral|End of life care coordination|
12061204|NCT00105599|Procedure|FairCare System|
12061205|NCT00105586|Drug|Escitalopram|Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
12061206|NCT00105573|Behavioral|Maternal interpersonal psychotherapy (IP)|Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
12061207|NCT00105573|Behavioral|Infant-parent psychotherapy|Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.
12061208|NCT00105573|Behavioral|Informational meetings plus treatment as usual|Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
12061209|NCT00105560|Radiation|radiation therapy|Radiation therapy with proton beam to standard doses
12061210|NCT00105547|Drug|MPC-7869|oral 800 mg BID
12061211|NCT00105547|Drug|MPC-7869|Oral BID dosing
12061212|NCT00105534|Drug|AzaSite|"1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected
~eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days."
12061213|NCT00105534|Other|Vehicle|Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
12061214|NCT00105521|Drug|Sarizotan|Sarizotan will be administered twice daily.
12061215|NCT00105521|Drug|Placebo|Placebo matching to sarizotan will be administered twice daily.
12061216|NCT00105508|Drug|Sarizotan|Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.
12061217|NCT00105508|Drug|Placebo|Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
12061218|NCT00105495|Drug|Ferriprox (deferiprone)|
12061219|NCT00105495|Drug|Desferal (deferoxamine)|
12061220|NCT00105482|Drug|Naltrexone|Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
12061221|NCT00105482|Drug|Transdermal nicotine replacement|Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
12061222|NCT00105482|Behavioral|Behavioral counseling|Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
12061223|NCT00105469|Drug|AzaSite|AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
12061224|NCT00105469|Drug|Tobramycin|Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.
12061225|NCT00105443|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
12061226|NCT00105443|Drug|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid).
12061227|NCT00105430|Procedure|Deep Brain Stimulation|
12061228|NCT00105417|Drug|IL-7|
12061229|NCT00105404|Drug|Triamcinolone Acetonide|
12061230|NCT00105378|Behavioral|Dutch EASYcare Study Geriatric Intermediate Care Programme|
12061231|NCT00105365|Device|Shoe insert|Subjects with knee OA underwent gait analysis and knee pain and function assessment at baseline while wearing walking shoes and after four weeks of wearing walking shoes with lateral-wedged insoles.
12061232|NCT00105365|Other|walking shoes|walking shoes
12061233|NCT00105352|Procedure|Mixed Meal Tolerance Test|
12061234|NCT00105352|Procedure|Glucagon Stimulation Test|
12061235|NCT00105326|Drug|paliperidone ER|
12061236|NCT00105313|Drug|MEDI-507|
12061237|NCT00105300|Drug|Adalimumab|
12061238|NCT00105287|Drug|OraVescent fentanyl (OVF)|
12061239|NCT00105248|Behavioral|patient-centered communication training|
12061240|NCT00105235|Drug|Alemtuzumab|T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4
12061241|NCT00105235|Drug|Cyclosporine|Oral immunosuppressant
12061242|NCT00105235|Drug|Mycophenolate mofetil|Oral immunosuppressant
12061243|NCT00105235|Drug|Tacrolimus|Oral immunosuppressant
12061244|NCT00105235|Procedure|Liver transplant|Occurs at study entry
12061245|NCT00105235|Procedure|Immunosuppression withdrawal|Beginning no earlier than Year 1
12061246|NCT00105222|Drug|Sodium Nitrite|
12061247|NCT00105209|Drug|Aspirin|
12061248|NCT00105209|Drug|clopidogrel|
12061249|NCT00105196|Drug|Aripiprazole+ ADT|Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
12061250|NCT00105196|Drug|Placebo+ ADT|Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
12061251|NCT00105183|Biological|Placebo|placebo infusion, single
12061252|NCT00105183|Biological|EZ-2053|single IV infusion, 9 mg/kg
12061253|NCT00105183|Biological|EZ-2053 5mg/kg|single IV infusion, 5mg/kg
12061254|NCT00105170|Drug|hCBE-11|
12061255|NCT00105157|Drug|Comparator: MK0518|MK0518 oral tablets 200 mg b.i.d, for 24 weeks
12061256|NCT00105157|Drug|MK0518|MK0518 oral tablets 400 mg b.i.d, for 24 weeks
12061257|NCT00105157|Drug|MK0518|MK0518 oral tablets 600 mg b.i.d, for 24 weeks
12061258|NCT00105157|Drug|Placebo|Placebo to MK0518, oral tablet b.i.d, for 24 weeks
12061259|NCT00105144|Drug|Micafungin|IV
12061260|NCT00105144|Drug|Caspofungin|IV
12061261|NCT00105118|Device|Magstim Super Rapid Magnetic Stimulator|
12061262|NCT00105105|Drug|Mifepristone|
12061263|NCT00105092|Drug|Enzastaurin HCL|
12061264|NCT00105079|Drug|saquinavir [Invirase]|1000 milligram (mg) Oral (po) twice daily (bid)
12061265|NCT00105079|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir 400/100 mg po bid
12061266|NCT00105079|Drug|Emtricitabine/tenofovir disoproxil fumarate|Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
12061267|NCT00105079|Drug|Ritonavir|100 mg po bid
12061268|NCT00105066|Drug|Metformin|850mg tablet once a day for one month, then twice a day for 3 months
12061269|NCT00105066|Drug|Placebo|placebo tablet once a day for one month, then twice a day for 3 months
12061270|NCT00105053|Biological|HyperAcute-Prostate Cancer Vaccine|Before enrollment in the Phase I and Phase II- Arm A studies, the patient must be determined to have measurable disease with biopsies on first recurrence or bone metastases. In the Phase II- Arm B study, patients will be men with non-measurable progressive disease as evidenced by elevated PSA only. Cells will be injected intradermally every two weeks for 12 cycles on a prime-boost regimen. Dosage will vary from 30 million to 500 million HAP cells.
12061271|NCT00105040|Drug|Levetiracetam|Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
12061272|NCT00105040|Other|Placebo (PB)|Oral tablets and oral solution
12061273|NCT00105027|Other|Standard Care|CRVO: observation; BRVO: standard care
12061274|NCT00105027|Drug|intravitreal triamcinolone injection|1 mg dose
12061275|NCT00105027|Drug|intravitreal triamcinolone injection|4 mg
12061276|NCT00105001|Drug|Fludarabine Phosphate|Given IV
12061277|NCT00105001|Radiation|Total-Body Irradiation|Undergo total-body irradiation
12061278|NCT00105001|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
12061279|NCT00105001|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
12061280|NCT00105001|Drug|Tacrolimus|Given IV or PO
12061281|NCT00105001|Drug|Mycophenolate Mofetil|Given PO
12061282|NCT00105001|Drug|Sirolimus|Given PO
12061283|NCT00104988|Drug|temozolomide|75 mg/m^2/day PO daily for 6 weeks followed by a 2-week break
12061284|NCT00104988|Drug|thalidomide|200 mg/day PO daily
12061285|NCT00104975|Biological|alemtuzumab|
12061286|NCT00104975|Biological|therapeutic allogeneic lymphocytes|
12061287|NCT00104975|Drug|fludarabine phosphate|
12061288|NCT00104975|Drug|melphalan|
12061289|NCT00104975|Drug|tacrolimus|
12061290|NCT00104975|Drug|thiotepa|
12061291|NCT00104975|Procedure|peripheral blood stem cell transplantation|
12061292|NCT00104962|Drug|lenalidomide|Given orally
12061293|NCT00104949|Biological|trastuzumab|
12061294|NCT00104936|Procedure|adjuvant therapy|
12061295|NCT00104936|Radiation|radiation therapy|
12061296|NCT00104936|Radiation|stereotactic radiosurgery|
12061297|NCT00104923|Drug|fenretinide|Current dose level as an IV continuous infusion via central line over 5 days. Cycle is repeated every 3 weeks for up to 6 cycles
12061298|NCT00104910|Radiation|Internal Radiation Therapy|
12061299|NCT00104910|Radiation|3-Dimensional Conformal Radiation Therapy|
12061300|NCT00104910|Biological|Cetuximab|Given IV
12061301|NCT00104910|Drug|Cisplatin|Given IV
12061302|NCT00104897|Drug|tanespimycin|
12061303|NCT00104884|Drug|Depsipeptide|Given IV
12061304|NCT00104871|Drug|Bortezomib|Administered IV at the dose of 1.3 mg/m^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).
12061305|NCT00104858|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
12061306|NCT00104858|Drug|Cyclosporine|Given PO
12061307|NCT00104858|Drug|Fludarabine Phosphate|Given IV
12061308|NCT00104858|Other|Laboratory Biomarker Analysis|Correlative studies
12061309|NCT00104858|Drug|Mycophenolate Mofetil|Given PO
12061310|NCT00104858|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo HSCT
12061311|NCT00104858|Other|Pharmacological Study|Correlative studies
12061312|NCT00104858|Biological|Rituximab|Given IV
12061313|NCT00104858|Radiation|Total-Body Irradiation|Undergo TBI
12061314|NCT00104845|Biological|human gp100 plasmid DNA vaccine|
12061315|NCT00104845|Biological|mouse gp100 plasmid DNA vaccine|
12061316|NCT00104819|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
12061317|NCT00104819|Biological|sargramostim|
12061318|NCT00104806|Dietary Supplement|cholecalciferol|100 milligrams orally once a day for 28 days
12061319|NCT00104806|Drug|arsenic trioxide|0.3 milligram/kilogram weight intravenously for 5 days (loading) then 0.25/kg weight intravenously biweekly
12061320|NCT00104793|Drug|carboplatin|
12061321|NCT00104793|Drug|irinotecan hydrochloride|
12061322|NCT00104780|Biological|EP-2101|
12061323|NCT00104780|Biological|incomplete Freund's adjuvant|
12061324|NCT00104767|Drug|celecoxib|
12061325|NCT00104754|Drug|liposomal SN-38|
12061326|NCT00104741|Drug|flutamide|
12061327|NCT00104741|Drug|triptorelin|
12061328|NCT00104741|Procedure|neoadjuvant therapy|
12061329|NCT00104741|Radiation|radiation therapy|
12061330|NCT00104728|Drug|ZD1839|
12061331|NCT00104715|Drug|antiandrogen therapy|
12061332|NCT00104715|Drug|docetaxel|
12061333|NCT00104715|Drug|goserelin acetate|
12061334|NCT00104715|Procedure|orchiectomy|
12061335|NCT00104702|Procedure|adjuvant therapy|
12061336|NCT00104702|Procedure|conventional surgery|
12061337|NCT00104702|Radiation|radiation therapy|
12061338|NCT00104689|Drug|capecitabine|
12061339|NCT00104689|Drug|oxaliplatin|
12061340|NCT00104676|Biological|bleomycin sulfate|At least one course administered
12061341|NCT00104676|Drug|cisplatin|At least one course administered
12061342|NCT00104676|Drug|etoposide|At least one course administered
12061343|NCT00104676|Drug|ifosfamide|Given in a dose-dense sequential fashion
12061344|NCT00104676|Drug|oxaliplatin|Given in a dose-dense sequential fashion
12061345|NCT00104676|Drug|paclitaxel|Given in a dose-dense sequential fashion
12061346|NCT00104663|Drug|Quinacrine|
12061347|NCT00104650|Genetic|AMG 162 180 mg (SC) q 12 weeks|A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.
12061348|NCT00104650|Drug|IV Bisphosphonate q 4 weeks|IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.
12061349|NCT00104650|Genetic|AMG 162- 180 mg q 4 weeks|A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.
12061350|NCT00104637|Drug|sildenafil citrate|sildenafil citrate 25 mg by mouth thrice daily (po tid)
12061351|NCT00104637|Drug|Placebo|25 mg po tid
12061352|NCT00104624|Drug|docetaxel|
12061353|NCT00104624|Procedure|quality-of-life assessment|
12061354|NCT00104611|Device|Repetitive Transcranial Magnetic Stimulation|
12061355|NCT00104598|Drug|Bupropion|
12061356|NCT00104598|Behavioral|Smoking Abstinence Program|This investigation was a randomized controlled study of two framed message conditions for smoking cessation in combination with open label bupropion SR (300 mg/day). Two hundred fifty-eight cigarette smokers were randomly assigned to receive either gain- or loss-framed video and printed messages encouraging smoking abstinence. Preproduced video and printed information were chosen as the intervention media because of their reliability in delivering specific framed messages. All participants were seen at a community mental health center for 6 months and received a 7-week supply of bupropion SR.
12061357|NCT00104572|Drug|Androgel (Testosterone Gel)|1 mg tablet for 12 months
12061358|NCT00104572|Drug|Anastrozole (Aromatase Inhibitor)|
12061359|NCT00104572|Drug|Placebo tablet|Daily for 12 months
12061360|NCT00104572|Drug|Placebo gel|Daily for 12 months
12061361|NCT00104572|Dietary Supplement|Calcium Cardone 500mg with vitamin D 400 IU|1 tablet three times a day
12061362|NCT00104559|Behavioral|iMIC-generated consent form and tutorial|Computer-based consent form and tutorial
12061363|NCT00104559|Behavioral|Standard paper consent form|Standard paper consent form
12061364|NCT00104546|Procedure|Acupuncture point injection of vitamin K|
12061365|NCT00104533|Device|Magnets|
12061366|NCT00104520|Drug|AZLI 75 mg two times a day (BID)/three times a day (TID)|
12061367|NCT00104520|Drug|Placebo two times a day (BID)/three times a day (TID)|
12061368|NCT00104507|Drug|APD356|
12061369|NCT00104494|Drug|Zinc acetate (20mg/d)|Randomized to receive either 20mg/d zinc as zinc acetate or an identical placebo
12061371|NCT00104468|Drug|Troxatyl™ (Cytotoxic Chemotherapeutic)|
12061372|NCT00104455|Drug|activated recombinant human factor VII|
12061373|NCT00104442|Drug|Rivastigmine|
12061374|NCT00104429|Drug|GW873140|
12061375|NCT00104429|Drug|Combivir|
12061376|NCT00104416|Drug|lamotrigine (LAMICTAL) extended-release|Primary experimental dosage form
12061377|NCT00104416|Drug|Placebo|Placebo control
12061378|NCT00104403|Drug|GW679769|
12061379|NCT00104403|Drug|Dexamethasone|
12061380|NCT00104403|Drug|Ondansetron Hydrochloride|
12061381|NCT00104390|Biological|Grass MATA MPL|
12061382|NCT00104377|Biological|Grass MATA MPL|
12061383|NCT00104364|Drug|MK0731|
12061384|NCT00104338|Drug|FK778|
12061385|NCT00104299|Drug|Rituximab plus cyclophosphamide placebo (rituximab group)|375 mg/m^2 infusions once weekly for 4 week
12061386|NCT00104299|Drug|Cyclophosphamide plus rituximab placebo (control group)|2 mg/kg/day orally for months 1-3
12061387|NCT00104299|Drug|Azathioprine|2 mg/kg/day orally for months 4-6
12061388|NCT00104299|Drug|Methylprednisolone (or other glucocorticoid)|1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab
12061389|NCT00104299|Drug|Prednisone|During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.
12061390|NCT00104286|Drug|Troxatyl™ (Cytotoxic Chemotherapeutic)|
12061391|NCT00104273|Drug|Rasagiline|
12061392|NCT00104260|Drug|sapropterin dihydrochloride|
12061393|NCT00104247|Drug|sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin|
12061394|NCT00104234|Drug|N-acetylgalactosamine 4-sulfatase|
12061395|NCT00104234|Drug|Placebo/rhASB|
12061396|NCT00104182|Drug|insulin detemir|
12061397|NCT00104182|Drug|insulin NPH|
12061398|NCT00104169|Drug|Epoetin Alfa|
12061399|NCT00104156|Procedure|External Qigong therapy|
12061400|NCT00104143|Drug|A4I Antagonist|
12061401|NCT00104130|Drug|KOS-862|
12061402|NCT00104117|Drug|XL999|XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.
12061403|NCT00104104|Drug|zoledronic acid|4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
12061404|NCT00104091|Drug|TP-38|TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.
12061405|NCT00104078|Drug|MYO-029|
12061406|NCT00104065|Drug|CG53135-05, velafermin|
12061407|NCT00104052|Biological|peginterferon alfa-2b (PEG2b) (SCH 54031)|PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks.
12061408|NCT00104052|Drug|ribavirin (SCH 18908)|15 mg/kg/day for up to 48 weeks
12061409|NCT00104013|Drug|xaliproden (SR57746A)|
12061410|NCT00103974|Biological|BHT-3009-01|
12061411|NCT00103961|Behavioral|Questionnaire|A behavioral questionnaire will occur at Week 8
12061412|NCT00103948|Drug|Aricept|
12061413|NCT00103935|Drug|placebo|Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
12061414|NCT00103935|Drug|placebo|Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg
12061415|NCT00103935|Drug|Exenatide LAR|Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
12061416|NCT00103935|Drug|Exenatide LAR|Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.
12061417|NCT00103922|Drug|cilomilast|
12061418|NCT00103870|Procedure|Electrodermal stimulation|
12061419|NCT00103870|Procedure|Music listening task|
12061420|NCT00103857|Drug|Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)|MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
12061421|NCT00103857|Drug|Comparator: MK0431 100 mg q.d. (q.d. = once daily)|MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
12061422|NCT00103857|Drug|Comparator: Placebo (Phase A)/Metformin (Phase B)|During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.
12061423|NCT00103857|Drug|Comparator: Metformin 500 mg b.i.d.|Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
12061540|NCT00103051|Drug|gefitinib|
12061424|NCT00103857|Drug|Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.|MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.
12061425|NCT00103857|Drug|Comparator: Metformin 1000 mg b.i.d.|Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
12061426|NCT00103844|Drug|Dasatinib|Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks
12061427|NCT00103844|Drug|Imatinib|Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks
12061428|NCT00103831|Drug|Oral Taxane|
12061429|NCT00103818|Drug|gaboxadol|Duration of Treatment: 3 months
12061430|NCT00103818|Drug|Comparator: placebo (unspecified)|Duration of Treatment: 3 months
12061431|NCT00103805|Drug|levodopa|
12061432|NCT00103792|Drug|mycophenolate mofetil|2000 mg mycophenolate per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
12061433|NCT00103792|Drug|cyclophosphamide|2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy
12061434|NCT00103779|Drug|SGN-40 (anti-huCD40 mAb)|1 mg/kg IV (in the vein) on Day 1; 1-2 mg/kg IV on Day 4; 2-4 mg/kg IV on Day 8; 3-8 mg/kg on Days 15, 22 and 29.
12061435|NCT00103766|Drug|Alteplase|
12061436|NCT00103753|Drug|deferiprone|
12061437|NCT00103740|Drug|zoledronic acid|5 mg zoledronic acid in 5 mL of sterile water for infusion
12061438|NCT00103740|Drug|placebo to zoledronic acid|5 mL of sterile water for infusion
12061439|NCT00103740|Drug|Risedronate|30mg oral tablets overencapsulated to match the placebo capsules
12061440|NCT00103740|Drug|Placebo to risedronate|oral capsules
12061441|NCT00103740|Drug|Calcium and vitamin D supplements|Calcium and vitamin D supplements were supplied
12061442|NCT00103727|Drug|Talnetant|talnetant
12061443|NCT00103727|Other|placebo|Placebo Comparator
12061444|NCT00103727|Other|risperidone|Active Comparator
12061445|NCT00103714|Drug|denufosol tetrasodium (INS37217)|
12061446|NCT00103701|Drug|Dasatinib|Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.
12061447|NCT00103675|Procedure|Acupuncture|
12061448|NCT00103662|Drug|Granulocyte colony-stimulating factor plus plerixafor|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
12061449|NCT00103662|Drug|Granulocyte colony-stimulating factor plus placebo|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
12061450|NCT00103649|Drug|xaliproden (SR57746A)|
12061451|NCT00103636|Procedure|Extending peripheral intravenous (IV) cannula dwell times|
12061452|NCT00103623|Drug|Plenaxis|
12061453|NCT00103610|Drug|Granulocyte colony-stimulating factor plus plerixafor|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
12061454|NCT00103610|Drug|Granulocyte colony-stimulating factor plus placebo|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
12061455|NCT00103597|Drug|Fludrocortisone|
12061456|NCT00103597|Drug|Domperidone|
12061457|NCT00103597|Behavioral|Conservative Measures for Orthostatic Hypotension|
12061458|NCT00103584|Biological|LC16m8 Smallpox Vaccine|
12061459|NCT00103571|Drug|Olanzapine|
12061460|NCT00103571|Drug|Aripiprazole|
12061461|NCT00103558|Drug|Lumiliximab with FCR|Dose, schedule, and duration specified in protocol
12061462|NCT00103545|Biological|ACA 125|
12061541|NCT00103051|Drug|gemcitabine hydrochloride|
12061542|NCT00103051|Procedure|conventional surgery|
12061463|NCT00103532|Behavioral|Healthy Choices - Motivational Enhancement Intervention|Participants who are randomized to the intervention group will participate in four sessions (over approximately 3 months) of Healthy Choices; a motivational enhancement intervention specifically designed to target multiple risk behaviors in HIV+ youth. Participants will receive individualized referrals at the fourth session.
12061464|NCT00103532|Behavioral|Standard care|Participants will receive standard care plus referrals at three months post-baseline
12061465|NCT00103519|Drug|DITPA (3,5-diiodothyropropionic acid)|
12061466|NCT00103519|Drug|Placebo|Placebo
12061467|NCT00103506|Drug|Bortezomib (VELCADE)|1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
12061468|NCT00103506|Drug|Bortezomib (VELCADE)|1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles..
12061469|NCT00103506|Drug|Doxorubicin hydrochloride (DOXIL/CAELYX)|mg/m^2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.
12061470|NCT00103493|Behavioral|Motivational interviewing|
12061471|NCT00103493|Behavioral|Targeted DVD-based educational program|
12061472|NCT00103467|Biological|rPA102 Vaccine|
12061473|NCT00103454|Drug|GW685698X|
12061474|NCT00103428|Biological|CG7870|
12061475|NCT00103415|Behavioral|Endurance training|
12061476|NCT00103415|Behavioral|Weight-lifting training|
12061477|NCT00103402|Drug|Alfuzosin|
12061478|NCT00103402|Drug|Placebo|
12061479|NCT00103389|Drug|PI-88|PI-88+docetaxel
12061480|NCT00103389|Drug|docetaxel|docetaxel only
12061481|NCT00103376|Drug|Velcade|"Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.
~Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break"
12061482|NCT00103376|Drug|LH-RH Agonist|given as a 3 month depo-injection
12061483|NCT00103376|Drug|Androgen Receptor Antagonists|given orally daily for 3 months
12061484|NCT00103363|Other|cytology specimen collection procedure|
12061485|NCT00103363|Other|physiologic testing|
12061486|NCT00103363|Procedure|annual screening|
12061487|NCT00103363|Procedure|study of high risk factors|
12061488|NCT00103350|Drug|TG100-115|
12061489|NCT00103337|Drug|cilengitide|Given IV
12061490|NCT00103337|Other|laboratory biomarker analysis|Correlative studies
12061491|NCT00103324|Drug|lapatinib ditosylate|Given orally
12061492|NCT00103324|Other|laboratory biomarker analysis|Correlative studies
12061493|NCT00103311|Drug|ispinesib|Given IV
12061494|NCT00103311|Other|laboratory biomarker analysis|Correlative studies
12061495|NCT00103298|Drug|FOLFOX regimen|
12061496|NCT00103298|Drug|fluorouracil|
12061497|NCT00103298|Drug|isolated perfusion|
12061498|NCT00103298|Drug|leucovorin calcium|
12061499|NCT00103298|Drug|melphalan|
12061500|NCT00103298|Drug|oxaliplatin|
12061501|NCT00103285|Drug|doxorubicin hydrochloride|Given IV or IT
12061502|NCT00103285|Radiation|3-dimensional conformal radiation therapy|Some patients undergo cranial radiotherapy
12061503|NCT00103285|Drug|cytarabine|Given IV or SC
12061504|NCT00103285|Drug|dexamethasone|Given IV or PO
12061505|NCT00103285|Drug|pegaspargase|Given IM
12061506|NCT00103285|Drug|methotrexate|Given IM or IT
12061507|NCT00103285|Drug|leucovorin calcium|Given PO
12061508|NCT00103285|Drug|mercaptopurine|Given PO
12061509|NCT00103285|Drug|cyclophosphamide|Given IV
12061510|NCT00103285|Drug|thioguanine|Given PO
12061511|NCT00103285|Drug|vincristine sulfate|Given IV
12061512|NCT00103272|Drug|tanespimycin|Given IV
12061513|NCT00103272|Drug|bortezomib|Given IV
12061514|NCT00103259|Drug|bortezomib|Given IV
12061515|NCT00103259|Drug|irinotecan hydrochloride|Given IV
12061516|NCT00103259|Other|laboratory biomarker analysis|Optional correlative studies
12061517|NCT00103246|Drug|silicon phthalocyanine 4|Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present).Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
12061518|NCT00103233|Biological|trastuzumab|
12061519|NCT00103233|Drug|vinorelbine tartrate|
12061520|NCT00103220|Drug|SJG-136|Given IV
12061521|NCT00103207|Biological|cetuximab|
12061522|NCT00103194|Drug|lapatinib ditosylate|Given PO
12061523|NCT00103194|Other|laboratory biomarker analysis|Correlative studies
12061524|NCT00103181|Radiation|3-dimensional conformal accelerated partial breast irradiation|
12061525|NCT00103181|Radiation|brachytherapy|
12061526|NCT00103181|Radiation|whole breast irradiation|Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
12061527|NCT00103181|Radiation|MammoSite or other single-entry intracavitary device|
12061528|NCT00103168|Drug|imatinib mesylate|400 mg/day for 2 years
12061529|NCT00103155|Procedure|conventional surgery|
12061530|NCT00103155|Procedure|radiofrequency ablation|
12061531|NCT00103142|Biological|falimarev|Given subcutaneously and intradermally
12061532|NCT00103142|Biological|inalimarev|Given subcutaneously and intradermally
12061533|NCT00103142|Biological|sargramostim|Given subcutaneously
12061534|NCT00103142|Biological|therapeutic autologous dendritic cells|Given subcutaneously and intradermally
12061535|NCT00103116|Biological|autologous dendritic cell cancer vaccine|"Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure.
~Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part."
12061536|NCT00103103|Drug|bortezomib|
12061537|NCT00103103|Drug|fluorouracil|
12061538|NCT00103103|Drug|leucovorin calcium|
12061539|NCT00103051|Drug|cisplatin|
12061543|NCT00103051|Procedure|neoadjuvant therapy|
12061544|NCT00103038|Procedure|3 Tesla Magnetic Resonance Imaging|Undergo 3T MRI
12061545|NCT00103038|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo 3T DCE-MRI
12061546|NCT00103038|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo 3T DSC-MRI
12061547|NCT00103038|Drug|Ferumoxytol|Given IV
12061548|NCT00103038|Drug|Gadolinium|Given IV
12061549|NCT00103038|Procedure|MRI-Based Angiogram|Undergo MRA
12061550|NCT00103025|Drug|Sodium Nitrite|
12061551|NCT00103025|Drug|Sodium Nitrite Injection|
12061552|NCT00103012|Drug|Gingko Biloba|Ginkgo Biloba 120 mg twice daily for 14 days
12061553|NCT00103012|Drug|Echinacea purpurea|Echinacea purpurea 500 mg three times daily for 14 days
12061554|NCT00103012|Drug|Panax ginseng|Panax ginseng 500 mg twice daily
12061555|NCT00102986|Drug|Lopinavir/ritonavir|
12061556|NCT00102973|Drug|TLK286 in Combination with Carboplatin|Experimental Arm
12061557|NCT00102973|Drug|Doxorubicin HCl Liposome Injection|Active Comparator
12061558|NCT00102960|Drug|Abacavir sulfate|Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.
12061559|NCT00102960|Drug|Didanosine|Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age. Guidelines for switching from first line to second line therapy are available in the protocol.
12061560|NCT00102960|Drug|Efavirenz|Second Line Regimen: taken orally once daily. Dosage depends on weight. Guidelines for switching from first line to second line therapy are available in the protocol.
12061561|NCT00102960|Drug|Lamivudine|First Line Regimen: 4 mg/kg taken orally twice daily
12061562|NCT00102960|Drug|Lopinavir/Ritonavir|First Line Regimen: taken orally twice daily. Dosage depends on age and weight.
12061563|NCT00102960|Drug|Nevirapine|Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.
12061564|NCT00102960|Drug|Zidovudine|First Line Regimen: 240 mg/m^2 taken orally twice daily
12061565|NCT00102947|Drug|daptomycin (up to 14 days)|
12061566|NCT00102934|Drug|Enfuvirtide-intensified HAART|90 mg tablet taken orally twice daily
12061567|NCT00102921|Drug|CCX282-B|
12061568|NCT00102908|Drug|Zoledronate|Zoledronate infusion
12061569|NCT00102908|Drug|Zoledronate placebo|Zoledronate placebo infusion
12061570|NCT00102895|Drug|CP-724,714|
12061571|NCT00102882|Drug|fluticasone propionate/salmeterol|
12061572|NCT00102882|Drug|salmeterol xinafoate|
12061573|NCT00102869|Drug|levodopa|100mg levodopa per day over 10 days/ treatment phase
12061574|NCT00102856|Drug|Pramipexole|
12061575|NCT00102856|Drug|Rivastigmine|
12061576|NCT00102843|Procedure|supplementation with folic acid and betaine|
12061577|NCT00102830|Drug|AMG 386|
12061578|NCT00102817|Drug|somatropin|
12061579|NCT00102804|Drug|Pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression
12061580|NCT00102804|Drug|Placebo|IV administration, q 21 days
12061581|NCT00102804|Other|Best Supportive Care|Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
12061582|NCT00102791|Drug|ICA-17043|
12061583|NCT00102778|Drug|GW873140|
12061584|NCT00102778|Drug|Kaletra (lopinavir/ritonavir)|
12061585|NCT00102765|Drug|fluticasone propionate/salmeterol powder|
12061586|NCT00102765|Drug|fluticasone propionate powder|
12061587|NCT00102752|Drug|Glufosfamide|
12061588|NCT00102752|Drug|Gemcitabine|
12061589|NCT00102739|Drug|SB497115|
12061590|NCT00102726|Drug|SB497115|SB497115/Placebo will be administered for at least 2 cycles. Additional cycles are permited if: 1) chemotherapy is continued, 2) the subject appears to be benefitting from the study drug, and 3) the subject has not encountered greater than moderate toxicity with the study drug. The maximum number of cycles would be 8.
12061591|NCT00102726|Other|Placebo|Placebo administered orally daily on days 2 through 11 of each 21-day cycle.
12061592|NCT00102713|Drug|Divalproex Sodium (Depakote Sprinkle Capsules)|
12061593|NCT00102700|Drug|ARQ 501 in combination with gemcitabine|
12061594|NCT00102687|Drug|azacitidine|"Azacitidine is administered subcutaneously
~Total of 18 cycles on treatment or early discontinuation."
12061595|NCT00102674|Drug|cangrelor|
12061596|NCT00102661|Drug|Campath-1H|15 mg daily infused over 24 hours, continuous infusion x 7 days (Days 1 through 7). Each 15 mg dose prepared daily, immediately prior to starting the infusion. Starting day 10, CAMPATH-1H administered at dose of 30 mg subcutaneously three times weekly for 11 additional weeks.
12061597|NCT00102648|Drug|Lonafarnib|Given PO
12061598|NCT00102648|Drug|Temozolomide|Given PO
12061599|NCT00102635|Drug|Fenretinide (4-HPR)|Oral 100 mg capsules in two divided doses at least 8 hours apart for 7 days each cycle.
12061600|NCT00102635|Drug|SCH66336|Oral capsules with 50 mg, 75 mg, or 100 mg formulation in two divided doses at least 8 hours apart for 21 days each cycle.
12061601|NCT00102622|Biological|Intraperitoneal tgDCC-E1A|Starting Dose Level: 1.8 mg DNA/m^2 intraperitoneal every 7 days +/- 2 days for a total of 6 treatments each cycle.
12061602|NCT00102622|Drug|Paclitaxel|80 mg/m^2 intravenous (IV) every 7 days +/- 2 days for a total of 6 treatments.
12061603|NCT00102609|Drug|Doxorubicin|Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1
12061604|NCT00102609|Drug|Trabectedin|Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles
12061605|NCT00102609|Drug|Dexamethasone|Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin
12061676|NCT00102011|Procedure|fecal occult blood test|Participants undergo a baseline fecal occult blood test (FOBT)
12061677|NCT00102011|Procedure|screening colonoscopy|Patients undergo baseline screening colonoscopy
12061678|NCT00102011|Procedure|standard follow-up care|Standard care
12061679|NCT00101998|Drug|alvimopan|
12061680|NCT00101998|Drug|placebo|
12061681|NCT00101985|Drug|talnetant|
12061606|NCT00102596|Drug|1-Octanol|1-Octanol is an long-chain alcohol with potential therapeutic benefits in treating alcohol-responsive tremors based on unknown mechanisms. The intervention consisted of either 1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; or 2) a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
12061607|NCT00102583|Drug|Subconjunctival Cyclosporine Implant|
12061608|NCT00102557|Drug|Hydroxychloroquine|
12061609|NCT00102544|Device|EM Tracking|Utilizing electromagnetic tracking technology as a fusion and navigation tool for minimally invasive interventional procedures.
12061610|NCT00102531|Drug|Cisplatin liposomal|
12061611|NCT00102518|Drug|Aripiprazole|2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses
12061612|NCT00102505|Drug|Motexafin Gadolinium Injection|
12061613|NCT00102492|Drug|GW679769|
12061614|NCT00102479|Drug|Aripiprazole|
12061615|NCT00102466|Drug|vildagliptin|
12061616|NCT00102466|Drug|Gliclazide|
12061617|NCT00102466|Drug|Metformin|
12061618|NCT00102453|Drug|Pentoxifylline|Pentoxifylline dosing: 20mg/Kg/day in a 20 mg/mL solution. Maximum dose of 1200mg/day. Dosing split into two equal parts taken morning and night with food.
12061619|NCT00102440|Drug|Febuxostat|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
12061620|NCT00102440|Drug|Febuxostat|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
12061621|NCT00102440|Drug|Allopurinol|Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.
12061622|NCT00102427|Behavioral|Telephone-based collaborative care management|
12061623|NCT00102414|Drug|Gemcitabine|
12061624|NCT00102401|Behavioral|Internet-based Dyspnea Self-Management Program|
12061625|NCT00102401|Behavioral|Face-to-face Dyspnea Self-Management Program|
12061626|NCT00102388|Drug|vildagliptin|
12061627|NCT00102388|Drug|Gliclazide|
12061628|NCT00102375|Drug|Topotecan|
12061629|NCT00102362|Behavioral|Behavior Therapy|
12061630|NCT00102349|Behavioral|Behavior Therapy|
12061631|NCT00102336|Biological|AMG 531|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
12061632|NCT00102336|Drug|Placebo|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.
12061633|NCT00102323|Drug|Placebo|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.
12061634|NCT00102323|Biological|AMG 531|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
12061635|NCT00102310|Drug|YM443|
12061636|NCT00102297|Drug|FG-3019|
12061637|NCT00102284|Drug|levodopa|
12061638|NCT00102284|Drug|rivastigmine|
12061639|NCT00102284|Drug|pergolid|
12061640|NCT00102284|Drug|modafinil|
12061641|NCT00102271|Drug|Oxypurinol|
12061642|NCT00102271|Drug|Sodium Nitrite|
12061643|NCT00102258|Drug|Growth Hormone Therapy|
12061644|NCT00102232|Procedure|supplementation with phosphatidylcholine|
12061645|NCT00102219|Drug|Pemetrexed|
12061646|NCT00102219|Drug|Doxorubicin|
12061647|NCT00102206|Drug|Abacavir sulfate|
12061648|NCT00102206|Drug|Emtricitabine|
12061649|NCT00102206|Drug|Lamivudine|
12061650|NCT00102206|Drug|Lopinavir/ritonavir|
12061651|NCT00102206|Drug|Saquinavir|
12061652|NCT00102206|Drug|Tenofovir disoproxil fumarate|
12061653|NCT00102206|Drug|Zidovudine|
12061654|NCT00102193|Device|Adacolumn Apheresis System|
12061655|NCT00102167|Drug|gaboxadol|Duration of Treatment -1 day
12061656|NCT00102154|Drug|MK0928, gaboxadol / Duration of Treatment: 10 months|
12061657|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
12061658|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
12061659|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
12061660|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
12061661|NCT00102141|Drug|Placebo|Placebo, given as tablets orally once daily in the morning for 8 weeks
12061662|NCT00102128|Drug|Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)|
12061663|NCT00102115|Drug|Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)|
12061664|NCT00102102|Drug|[18F]SPA-RQ|
12061665|NCT00102089|Biological|VRC-HIVADV014-00-VP booster|
12061666|NCT00102089|Drug|VRC-HIVADV014-00-VP|
12061667|NCT00102063|Drug|Aripiprazole tablet, 10 mg|Aripiprazole tablet 10 mg po qd x 42 days
12061668|NCT00102063|Drug|Aripiprazole tablet, 30 mg|Aripiprazole tablet 30 mg po qd x 42 days
12061669|NCT00102063|Drug|Placebo tablet|Placebo tablet po qd x 42 days
12061670|NCT00102050|Drug|NM-702 (phosphodiesterase inhibitor)|
12061671|NCT00102037|Drug|eptacog alfa (activated)|
12061672|NCT00102024|Drug|Unconjugated IDEC-159|
12061673|NCT00102024|Drug|111In-IDEC-159|
12061674|NCT00102024|Drug|90Y-IDEC-159|
12061675|NCT00102011|Procedure|annual screening|Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
12061791|NCT00101127|Biological|pegfilgrastim|
12061682|NCT00101972|Biological|monoclonal antibody RAV12|Escalating doses of RAV12 (weekly 0.3, 1.0, 1.5, 3.0, 4.0, 5.0, 6.0 mg/kg or 0.5 mg/kg BIW or TIW; 0.75 mg/kg BIW) for 4 weeks
12061683|NCT00101959|Drug|Rebif|
12061684|NCT00101946|Drug|683699|
12061685|NCT00101933|Device|Medtronic DBS Therapy for epilepsy|Stimulation On
12061686|NCT00101933|Device|Medtronic DBS Therapy for epilepsy|Stimulation Off
12061687|NCT00101920|Drug|ABX-EGF|2.5 mg/kg by an infusion pump over one hour
12061688|NCT00101907|Drug|AMG 706|AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.
12061689|NCT00101907|Biological|Panitumumab|Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.
12061690|NCT00101907|Drug|Gemcitabine|Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m^2.
12061691|NCT00101907|Drug|Cisplatin|Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
12061692|NCT00101894|Drug|FOLFOX-4|"The FOLFOX-4 regimen will be administered every 2 weeks as follows:
~Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed"
12061693|NCT00101894|Drug|AMG 706|AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
12061694|NCT00101894|Biological|Panitumumab (Part 1a only)|Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
12061695|NCT00101894|Drug|FOLFIRI|Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
12061696|NCT00101881|Device|Defibrillation (biphasic versus monophasic shock)|Administration of monophasic or biphasic waveform defibrillation
12061697|NCT00101868|Device|Discharge communication software|Computerized physician order entry software used by discharging physician
12061698|NCT00101868|Other|Usual care discharge process|Handwritten
12061699|NCT00101855|Procedure|An evidence based tailored web site|
12061700|NCT00101842|Drug|Pemetrexed|
12061701|NCT00101842|Drug|Gemcitabine|
12061702|NCT00101842|Drug|Platinol|
12061703|NCT00101829|Drug|Rituximab|1000 mg intravenous infusion
12061704|NCT00101816|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.
12061705|NCT00101803|Drug|vildagliptin|
12061706|NCT00101790|Drug|pamidronate|There will be four study groups, each with 7 subjects randomly assigned to pamidronate and 4 to placebo. The groups will occur in succession, not parallel. The dosage for group 1 will be 30 mg , 60 mg for group 2, and 90 mg for group 3. Group 4 will receive 2 treatments of 90mg IV pamidronate or placebo.
12061707|NCT00101764|Drug|Triamcinolone Acetonide|
12061708|NCT00101751|Drug|biphasic insulin aspart|
12061709|NCT00101751|Behavioral|dietary regimen|
12061710|NCT00101738|Drug|Myfortic|
12061711|NCT00101725|Drug|crofelemer|
12061712|NCT00101712|Drug|vildagliptin|
12061713|NCT00101712|Drug|Vildagliptin Placebo|
12061714|NCT00101686|Drug|Modified Bolus 5-FU/LV with Irinotecan|Day 1 & 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID [two times a day] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
12061715|NCT00101686|Drug|FOLFIRI + bevacizumab|"Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
~I m m e d i a t e l y f o l l o w e d b y :
~5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks
~Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
~I m m e d i a t e l y f o l l o w e d b y :
~5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID [two times a day] oral Every 2 weeks"
12061716|NCT00101686|Drug|miFL + bevacizumab|Day 1 Bevacizumab 7.5mg/kg IV *over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID [two times a day] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID [two times a day] continues daily without interruption Every 3 weeks
12061717|NCT00101686|Drug|Infusional 5-FU/LV with Irinotecan|Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID [two times a day](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
12061792|NCT00101127|Drug|docetaxel|
12061793|NCT00101127|Drug|gemcitabine hydrochloride|
12061794|NCT00101114|Drug|sorafenib tosylate|Given PO
12061795|NCT00101114|Biological|recombinant interferon alfa-2b|Given SC
12061796|NCT00101114|Other|laboratory biomarker analysis|Optional correlative studies
12061718|NCT00101686|Drug|Oral Capecitabine with Irinotecan|Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID [two times a day] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
12061719|NCT00101673|Drug|vildagliptin|
12061720|NCT00101660|Drug|Dasatinib|Tablets; oral; 70 mg BID, depending on response
12061721|NCT00101647|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure
12061722|NCT00101634|Drug|Paliperidone palmitate|
12061723|NCT00101621|Drug|M40403|
12061724|NCT00101608|Drug|vinflunine|solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
12061725|NCT00101595|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure
12061726|NCT00101582|Drug|Placebo|
12061727|NCT00101582|Drug|palifermin|
12061728|NCT00101582|Drug|cisplatin chemotherapy|Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m^2 on Days 1, 22, and 43.
12061729|NCT00101582|Radiation|Radiotherapy|Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.
12061730|NCT00101569|Drug|Aripiprazole|Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).
12061731|NCT00101569|Drug|Aripiprazole|Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).
12061732|NCT00101543|Device|Electrical Stimulation with Intramuscular Electrodes|
12061733|NCT00101543|Procedure|Body Weight Supported Treadmill Training|
12061734|NCT00101491|Behavioral|Health Communication DVD video|Interactive, testimonial-based, stage of change-matched Health Communication DVD video interventions
12061735|NCT00101452|Drug|S-adenosyl-l-methionine|1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks
12061736|NCT00101452|Drug|Escitalopram|10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks
12061737|NCT00101452|Drug|Placebo|placebo capsules look like escitalopram capsules and SAMe capsules
12061738|NCT00101439|Drug|ezetimibe|
12061739|NCT00101439|Drug|Comparator: placebo|
12061740|NCT00101426|Drug|ranirestat, (AS-3201)|
12061741|NCT00101413|Drug|Sorafenib (Nexavar, BAY43-9006)|BAY43-9006 400 mg bid X 28 day cycles [Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.
12061742|NCT00101400|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
12061743|NCT00101387|Other|Lumbar PENS + General Conditioning and Aerobic Exercise|As above
12061744|NCT00101387|Other|Lumbar PENS|As above
12061745|NCT00101387|Other|Control Lumbar PENS|Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
12061746|NCT00101387|Other|Control PENS + exercise|as above
12061747|NCT00101374|Drug|Leflunomide|
12061748|NCT00101361|Drug|Oxandrolone|Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.
12061749|NCT00101361|Drug|Placebo|Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.
12061750|NCT00101348|Drug|erlotinib hydrochloride|Given orally
12061751|NCT00101348|Biological|cetuximab|Given IV
12061752|NCT00101348|Biological|bevacizumab|Given IV
12061753|NCT00101348|Other|laboratory biomarker analysis|Correlative studies
12061754|NCT00101335|Drug|celecoxib|
12061755|NCT00101309|Biological|aldesleukin|
12061756|NCT00101309|Biological|autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine|
12061757|NCT00101309|Biological|therapeutic autologous lymphocytes|
12061758|NCT00101296|Drug|tipifarnib|Given orally
12061759|NCT00101296|Other|pharmacological study|Correlative studies
12061760|NCT00101296|Other|laboratory biomarker analysis|Correlative studies
12061761|NCT00101283|Drug|pemetrexed disodium|500 mg/m2 IV over 10 minutes on day 1 of a 21-day cycle
12061762|NCT00101283|Drug|gemcitabine hydrochloride|1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle
12061763|NCT00101283|Drug|carboplatin|Given by IV over 30 minutes at an area under the curve (AUC) of 5 on day 1 of a 21-day cycle
12061764|NCT00101270|Drug|irinotecan hydrochloride|Given IV
12061765|NCT00101270|Drug|oxaliplatin|Given IV
12061766|NCT00101257|Biological|therapeutic autologous lymphocytes|
12061767|NCT00101244|Drug|ispinesib|Given IV
12061768|NCT00101244|Other|laboratory biomarker analysis|Correlative studies
12061769|NCT00101244|Other|pharmacological study|Correlative studies
12061770|NCT00101231|Drug|alvocidib|Given IV
12061771|NCT00101205|Drug|oxaliplatin|Given IV
12061772|NCT00101205|Drug|etoposide|Given IV
12061773|NCT00101192|Biological|cetuximab|
12061774|NCT00101192|Drug|cisplatin|
12061775|NCT00101179|Drug|Azacitidine|Given SC
12061776|NCT00101179|Drug|Entinostat|Given orally
12061777|NCT00101166|Biological|Bystander-Based Autologous Tumor Cell Vaccine|The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.
12061778|NCT00101153|Drug|cytarabine|
12061779|NCT00101153|Drug|daunorubicin hydrochloride|
12061780|NCT00101153|Drug|tipifarnib|
12061781|NCT00101140|Drug|anti-thymocyte globulin|
12061782|NCT00101140|Drug|fludarabine phosphate|
12061783|NCT00101140|Drug|thiotepa|
12061784|NCT00101140|Procedure|biological therapy|
12061785|NCT00101140|Procedure|bone marrow ablation with stem cell support|
12061786|NCT00101140|Procedure|chemotherapy|
12061787|NCT00101140|Procedure|non-specific immune-modulator therapy|
12061788|NCT00101140|Procedure|peripheral blood stem cell transplantation|
12061789|NCT00101140|Procedure|radiation therapy|
12061790|NCT00101127|Biological|filgrastim|
12061797|NCT00101101|Drug|Cyclophosphamide|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
12061798|NCT00101101|Drug|Doxorubicin|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
12061799|NCT00101101|Drug|Vincristine|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
12061800|NCT00101101|Drug|Prednisone|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
12061801|NCT00101101|Drug|Dexamethasone|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
12061802|NCT00101101|Biological|Autologous Tumor Cell-Based Vaccine|Participants receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2 as above.
12061803|NCT00101101|Drug|IL-2|Participants receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2 as above.
12061804|NCT00101088|Drug|imatinib mesylate|Given orally
12061805|NCT00101088|Drug|temsirolimus|Given IV
12061806|NCT00101088|Other|laboratory biomarker analysis|Correlative studies
12061807|NCT00101075|Drug|Capecitabine|
12061808|NCT00101075|Drug|Oxaliplatin|
12061809|NCT00101062|Drug|celecoxib|
12061810|NCT00101062|Drug|letrozole|
12061811|NCT00101036|Drug|lapatinib ditosylate|Given PO
12061812|NCT00101036|Other|laboratory biomarker analysis|Correlative studies
12061813|NCT00101010|Biological|Filgrastim|5 mcg/kg, SC daily, start 24 hours after chemotherapy
12061814|NCT00101010|Biological|Pegfilgrastim|6 mg SC one time (24 hours after chemotherapy)
12061815|NCT00101010|Biological|Rituximab|375 mg/m^2 intravenous piggy back (IVPB) on day 1, administered 1st
12061816|NCT00101010|Drug|Cyclophosphamide|750 mg/m^2 IVPB on day 1
12061817|NCT00101010|Drug|Pegylated liposomal doxorubicin hydrochloride|40 mg/m^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1
12061818|NCT00101010|Drug|Prednisone|40 mg/m^2 oral days 1 - 5.
12061819|NCT00101010|Drug|Vincristine Sulfate|2 mg IV, day 1
12061820|NCT00100997|Drug|tanespimycin|
12061821|NCT00100984|Drug|FUZEON [enfuvirtide]|
12061822|NCT00100971|Drug|autologous tumor cell vaccine|
12061823|NCT00100971|Drug|therapeutic autologous dendritic cells|
12061824|NCT00100971|Procedure|tumor cell-derivative vaccine therapy|
12061825|NCT00100958|Drug|indole-3-carbinol|
12061826|NCT00100945|Drug|gefitinib|
12061827|NCT00100932|Drug|E7389 28 Day Cycle|E7389 1.4 mg/m^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle.
12061828|NCT00100932|Drug|E7389 21 Day Cycle|E7389 1.4 mg/m^2 IV bolus on Days 1 and 8 of a 21 day cycle.
12061829|NCT00100906|Drug|IL-2|Immunotherapy with interleukin-2
12061830|NCT00100906|Drug|ATRA|
12061831|NCT00100893|Dietary Supplement|IH636 grape seed proanthocyanidin extract|Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage
12061832|NCT00100880|Drug|lenalidomide|Given PO
12061833|NCT00100880|Procedure|perfusion-weighted magnetic resonance imaging|Correlative studies
12061834|NCT00100880|Procedure|diffusion-weighted magnetic resonance imaging|Correlative studies
12061835|NCT00100880|Other|laboratory biomarker analysis|Correlative studies
12061836|NCT00100854|Drug|erlotinib hydrochloride|Given orally
12061837|NCT00100854|Drug|fulvestrant|Given intramuscularly
12061838|NCT00100841|Biological|cetuximab|Given IV
12061839|NCT00100841|Biological|bevacizumab|Given IV
12061840|NCT00100841|Drug|oxaliplatin|Given IV
12061841|NCT00100841|Drug|leucovorin calcium|Given IV
12061842|NCT00100841|Drug|fluorouracil|Given IV
12061843|NCT00100828|Drug|irinotecan hydrochloride|
12061844|NCT00100815|Biological|bevacizumab|30-90 minutes on day 1, every 21 days up to 12 months.
12061845|NCT00100815|Drug|capecitabine|twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
12061846|NCT00100815|Drug|gemcitabine hydrochloride|IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
12061847|NCT00100802|Drug|lomustine|Capsule
12061848|NCT00100802|Drug|temozolomide|Capsule
12061849|NCT00100802|Procedure|adjuvant therapy|
12061850|NCT00100802|Radiation|radiation therapy|
12061851|NCT00100789|Drug|gemcitabine|3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
12061852|NCT00100789|Drug|paclitaxel|150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
12061853|NCT00100776|Drug|Olanzapine|
12061854|NCT00100750|Drug|Gemcitabine Hydrochloride|Given IV
12061855|NCT00100750|Drug|Tipifarnib|Given PO
12061856|NCT00100750|Other|Laboratory Biomarker Analysis|Correlative studies
12061857|NCT00100737|Drug|interleukin-2|
12061858|NCT00100737|Drug|rituximab|
12061859|NCT00100724|Biological|rPA102|
12061860|NCT00100711|Drug|Motexafin Gadolinium|
12061861|NCT00100698|Drug|recombinant human growth hormone|growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
12061862|NCT00100698|Drug|placebo|placebo subcutaneously once a day, 18 months
12061863|NCT00100685|Drug|Volociximab (anti-α5β1 integrin monoclonal antibody)|Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.
12061864|NCT00100672|Drug|LErafAON-ETU|
12061865|NCT00100659|Drug|Pegylated Interferon/ribavirin|
12061866|NCT00100646|Behavioral|Structured treatment interruption|Interruptions in treatment will last 2, 4, and 8 weeks in between 16-week periods of ART
12061867|NCT00100646|Drug|Lamivudine|300 mg tablet taken orally daily
12061868|NCT00100646|Drug|Lopinavir/Ritonavir|400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
12061869|NCT00100646|Drug|Stavudine|Dosage dependent on weight
12061870|NCT00100646|Biological|Rabies de novo antigen|Vaccine injected intramuscularly
12061871|NCT00100633|Drug|CpG7909 oligodeoxynucleotides (ODN)|
12061872|NCT00100633|Biological|Hepatitis B virus vaccine|
12061873|NCT00100620|Drug|Zoledronic Acid|
12061874|NCT00100607|Drug|AAE581|
12061875|NCT00100594|Drug|Efavirenz|
12061876|NCT00100594|Drug|Lamivudine/zidovudine|
12061877|NCT00100581|Drug|Efavirenz|
12061878|NCT00100581|Drug|Lamivudine|
12061879|NCT00100581|Drug|Lopinavir/ritonavir|
12061880|NCT00100581|Drug|Pegylated interferon alfa-2a|
12061881|NCT00100581|Drug|Ribavirin|
12061882|NCT00100581|Drug|Tenofovir disoproxil fumarate|
12061883|NCT00100568|Drug|Efavirenz|600 mg tablet taken orally daily
12061884|NCT00100568|Drug|Lamivudine/zidovudine|150mg lamivudine/300mg zidovudine tablet taken orally twice daily
12061885|NCT00100555|Drug|zoledronic acid|
12061886|NCT00100542|Behavioral|Psychiatric interviews|Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
12061887|NCT00100477|Drug|Topotecan|
12061888|NCT00100477|Drug|Mitozantrone|
12061889|NCT00100477|Drug|Etoposide|
12061890|NCT00100464|Drug|Paroxetine|
12061891|NCT00100464|Drug|5HTP|
12061892|NCT00100451|Procedure|exercise|
12061893|NCT00100425|Procedure|Viceral Perception Testing|
12061894|NCT00100412|Drug|Graded dobutamine infusions|
12061895|NCT00100412|Drug|Graded phenylephrine injections|
12061896|NCT00100412|Behavioral|Psychosocial challenge involving socioevaluative public speaking|
12061897|NCT00100399|Biological|Fluarix|
12061898|NCT00100386|Procedure|Intensive Control Strategy|
12061899|NCT00100386|Behavioral|Standard Control Strategy|
12061900|NCT00100373|Drug|RSV challenge material|
12061901|NCT00100347|Drug|PPI-2458|
12061902|NCT00100334|Drug|PPI-1019 (APAN)|
12061903|NCT00100308|Drug|Unfractioned heparin|Low-dose continuous-infusion, 500 units/hour per seven days
12061904|NCT00100308|Drug|saline|Saline placebo
12061905|NCT00100295|Drug|Hypericum perforatum|300 mg capsule taken three times a day
12061906|NCT00100295|Other|Placebo|300 mg given three times a day, containing rice protein powder
12061907|NCT00100282|Drug|PPI-1019 (APAN)|
12061908|NCT00100269|Drug|Menevit anti-oxidant|
12061909|NCT00100256|Drug|Rhenium (Re 188 P2045, BAY86-5284)|Infusion once only
12061910|NCT00100243|Drug|Plenaxis|
12061911|NCT00100230|Drug|docosahexaenoic acid OR corn/soy oil placebo|daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial
12061912|NCT00100191|Procedure|uterine artery embolization|
12061913|NCT00100191|Procedure|hysterectomy|
12061914|NCT00100178|Drug|Mycophenolate mofeteil (MMF)|
12061915|NCT00100178|Drug|Daclizumab (DZB)|
12061916|NCT00100178|Drug|Placebo control for Mycophenolate mofeteil (MMF)|Placebo pills taken orally
12061917|NCT00100178|Drug|Placebo control for Daclizumab (DZB)|saline intravenous infusions
12061918|NCT00100165|Drug|Placebo|Placebo by mouth twice a day for 4 weeks
12061919|NCT00100165|Drug|3-(2,4 dimethoxybenzylidene anabaseine) 150 mg|3-(2,4 dimethoxybenzylidene) 150 mg by mouth twice a day for 4 weeks
12061920|NCT00100165|Drug|3-(2,4 dimethoxybenzylidene anabaseine) 75 mg|3-(2,4 dimethoxybenzylidene) 75 mg by mouth twice a day for 4 weeks
12061921|NCT00100152|Drug|MK0752, (Notch Inhibitor)|
12061922|NCT00100139|Drug|Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU)|
12061923|NCT00100139|Drug|Paclitaxel for injection (Taxol)|
12061924|NCT00100126|Drug|Amoxicillin Pulsatile Release Multiparticluate Sprinkle|
12061925|NCT00100113|Drug|GBR 12909|
12061926|NCT00100100|Drug|Modafinil|
12061927|NCT00100087|Device|Ocular Brachytherapy|
12061928|NCT00100074|Drug|Lobeline|
12061929|NCT00100061|Drug|Cranberry juice|liquid juice taken daily
12061930|NCT00100061|Dietary Supplement|Cranberry Juice|Taken orally
12061931|NCT00100061|Dietary Supplement|Placebo cranberry juice|Placebo comparitor
12061932|NCT00100048|Drug|Comparator: MK0518 monotherapy|MK0518 twice daily for 10 days
12061933|NCT00100048|Drug|Comparator: MK0518 combination therapy|MK0518 twice daily for 48 weeks
12061934|NCT00100048|Drug|Comparator: efavirenz|efavirenz 600 mg every night at bedtime for 48 weeks
12061935|NCT00100048|Drug|Comparator: tenofovir|tenofovir 300 mg daily for 48 weeks
12061936|NCT00100048|Drug|Comparator: lamivudine|lamivudine 300 mg daily for 48 weeks
12061937|NCT00100048|Drug|Placebo monotherapy|Placebo to MK0518 twice daily
12061938|NCT00100035|Procedure|Polarity therapy|
12061939|NCT00100009|Drug|TAC-PF|
12061940|NCT00100009|Drug|Triamcinolone Acetonide|
12061941|NCT00099996|Drug|SCH-58235|
12061943|NCT00099983|Drug|Risperidone|Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time.
12061944|NCT00099983|Drug|Placebo|Placebo
12061945|NCT00099970|Drug|M200 (volociximab) in Combination with Dacarbazine (DTIC)|
12061946|NCT00099957|Drug|vildagliptin|
12061947|NCT00099944|Drug|vildagliptin|
12061948|NCT00099944|Drug|Glimepiride|Glimepiride 4 mg qd
12061949|NCT00099944|Drug|LAF237 placebo|
12061950|NCT00099931|Drug|vildagliptin|
12061951|NCT00099918|Drug|vildagliptin|
12061952|NCT00099905|Drug|vildagliptin|
12061953|NCT00099892|Drug|vildagliptin|
12061954|NCT00099879|Drug|BMS-275183|
12061955|NCT00099866|Drug|vildagliptin|
12061956|NCT00099866|Drug|Metformin Comparator|
12061957|NCT00099853|Drug|Vildagliptin|Vildagliptin 50 mg tablets
12061958|NCT00099853|Drug|pioglitazone|pioglitazone 45 mg qd
12061959|NCT00099853|Drug|Placebo|Vildagliptin matching placebo
12061960|NCT00099840|Procedure|Procalcitonin guided antibiotic therapy|
12061961|NCT00099827|Behavioral|Education|Individuals will receive information about depression
12061962|NCT00099814|Procedure|Two different loop designs which deliver distinctive forces|
12061963|NCT00099801|Drug|FTY720|
12061964|NCT00099788|Drug|Ranolazine|IV to oral transition.
12061965|NCT00099788|Drug|Placebo|IV to oral transition.
12061966|NCT00099775|Drug|Caspofungin|
12061967|NCT00099749|Drug|FTY 720|
12061968|NCT00099736|Drug|FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids|FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
12061969|NCT00099736|Drug|FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids|FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
12061970|NCT00099736|Drug|MMF 2 g + full-dose Neoral (FDN) + corticosteroids|mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
12061971|NCT00099723|Drug|VSL#3|
12061972|NCT00099710|Dietary Supplement|Curcumin C3 Complex|
12061973|NCT00099697|Drug|DHEA|
12061974|NCT00099684|Drug|Ezetimibe|
12061975|NCT00099671|Drug|Recombinant human interleukin-7|
12061976|NCT00099658|Biological|Pneumococcal polysaccharide-protein conjugate vaccine|Injection administered three times before the age of 24 weeks
12061977|NCT00099645|Drug|Mifepristone|
12061978|NCT00099632|Drug|Emtricitabine/Tenofovir Disoproxil Fumarate|200mg/300mg as one tablet taken orally once daily
12061979|NCT00099632|Drug|Lamivudine/Zidovudine|150mg/300mg as one tablet taken orally twice daily
12061980|NCT00099632|Drug|Lopinavir/Ritonavir|133.3mg/33.3mg as three capsules taken orally twice daily
12061981|NCT00099632|Drug|single dose Nevirapine|one 200 mg tablet taken orally
12061982|NCT00099619|Drug|exenatide/insulin glargine|Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
12061983|NCT00099619|Drug|insulin glargine/exenatide|Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks
12061984|NCT00099606|Drug|Dasatinib|Tablets, Oral, Dose Finding Study - Range was 35 mg BID, 5 days on/2 days off - 120 mg BID Continuous Daily Dosing, Once daily, Patients remained on study until treatment discontinuation due to unacceptable toxicity, disease progression or death.
12061985|NCT00099593|Biological|Autologous Dendritic Cell Vaccine|
12061986|NCT00099580|Drug|AC2592|continuous subcutaneous infusion (via pump), dose based on subject body weight
12061987|NCT00099580|Drug|placebo|continuous subcutaneous infusion (via pump), dose based on subject body weight
12061988|NCT00099554|Drug|Etanercept|
12061989|NCT00099541|Drug|zoledronic acid|
12061990|NCT00099528|Drug|REN-1654|
12061991|NCT00099515|Drug|LY041001 (HIIP)|Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
12061992|NCT00099515|Drug|LY041001 (HIIP)|Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU
12061993|NCT00099502|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|250mcg administered s.c. every other day
12061994|NCT00099502|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|500mcg administered s.c. every other day
12061995|NCT00099502|Drug|Copaxone|20 mg administered s.c. once daily.
12061996|NCT00099489|Drug|Interferon Beta-1a|
12061997|NCT00099476|Behavioral|Effects of dark chocolate|
12061998|NCT00099463|Procedure|Blood Test|
12061999|NCT00099463|Procedure|Urine Test|
12062000|NCT00099463|Procedure|Physical Exam|
12062001|NCT00099463|Drug|Vaccine|
12062002|NCT00099463|Drug|VRC-SRSDNA015-00-VP|
12062003|NCT00099450|Drug|INS50589 Intravenous Infusion|
12062004|NCT00099437|Drug|Fulvestrant|intramuscular injection
12062005|NCT00099424|Behavioral|High-intensity exercise training|
12062006|NCT00099385|Behavioral|Social Development Instruction|Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg & Kusche) curriculum.
12062007|NCT00099359|Drug|Zidovudine|Given for 6 weeks. 12mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams
12062008|NCT00099359|Drug|Nevirapine (NVP)|"Standard of Care (Zidovudine) plus
~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
12062009|NCT00099359|Drug|Epivir (3TC)|"Stand of care (Zidovudine) plus
~3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
~NFV, given for 2 weeks:
~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
12062010|NCT00099359|Drug|Nelfinavir (NFV)|200 mg BID if birth weight (BW) > 3000 grams for 2 weeks;150 mg BID if BW > 2000-3000 grams for 2 weeks; 100 mg BID BW </= 2000 grams for 2 weeks
12062011|NCT00099346|Drug|MK0457, VX-680 (Aurora Kinase Inhibitor)|
12062012|NCT00099333|Drug|exenatide|Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
12062013|NCT00099333|Drug|Insulin|Insulin will be taken according to the subject's current regimen
12062014|NCT00099320|Drug|exenatide|After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.
12062015|NCT00099320|Drug|Placebo|After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.
12062016|NCT00099294|Drug|Glufosfamide|
12062017|NCT00099281|Drug|YMB 1002|
12062018|NCT00099268|Drug|Carbidopa/levodopa/entacapone|Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
12062019|NCT00099268|Drug|Immediate release carbidopa/levodopa|Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
12062020|NCT00099255|Drug|SGN-30|
12062021|NCT00099242|Drug|rivastigmine transdermal patch|
12062022|NCT00099229|Drug|Licarbazepine|
12062023|NCT00099216|Drug|Rivastigmine|
12062024|NCT00099203|Drug|ibandronate [Bondronat]|6mg iv on days 1-3, and every 3-4 weeks
12062025|NCT00099203|Drug|zoledronic acid|4mg iv on day 1 and every 3-4 weeks
12062026|NCT00099190|Drug|ARQ 501|
12062027|NCT00099177|Drug|ibandronate [Bondronat]|6mg iv on days 1-3, and 50mg po from day 22 to week 24
12062028|NCT00099177|Drug|zoledronic acid|4mg iv on day 1, and every 3-4 weeks
12062029|NCT00099164|Drug|17 alpha-hydroxyprogesterone caproate (17P)|Study coded medication is 250 mg of 17P as a 1 ml intramuscular injection (or 1 ml of placebo inert oil). Patients are seen weekly to administer the study drug through 34 weeks 6 days gestation or delivery, whichever occurs first.
12062030|NCT00099151|Behavioral|Caloric Restriction (CR)|
12062031|NCT00099151|Behavioral|Exercise|
12062032|NCT00099138|Behavioral|Caloric Restriction (CR)|
12062033|NCT00099138|Behavioral|Exercise|
12062034|NCT00099125|Drug|irinotecan hydrochloride|
12062035|NCT00099125|Drug|temozolomide|
12062036|NCT00099125|Procedure|adjuvant therapy|
12062037|NCT00099125|Radiation|radiation therapy|
12062038|NCT00099112|Genetic|microarray analysis|
12062039|NCT00099112|Procedure|biopsy|
12062040|NCT00099112|Procedure|evaluation of cancer risk factors|
12062041|NCT00099099|Behavioral|Caloric Restriction (CR)|
12062042|NCT00099086|Drug|Bicalutamide|Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)
12062043|NCT00099086|Drug|docetaxel|Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2
12062044|NCT00099086|Drug|GnRh analog|"A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)
~Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)"
12062045|NCT00099086|Radiation|radiotherapy|External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.
12062046|NCT00099060|Drug|lapatinib ditosylate|"For patients receiving enzyme inducing anti-epileptic drugs (EIAEDs):
~Phase I: starting dose for first cohort: 1000 mg GW572016 po b.i.d.; actual dose assigned at registration; intra patient dose escalation permitted ONCE in phase I patients ONLY if specified criteria met (see section 8.6).
~Phase II: Recommended phase II dose from phase I portion of the study, given po b.i.d.
~For patients NOT receiving enzyme inducing anti-epileptic drugs (NON-EIAEDs):
~• Phase II: 750 mg GW572016 po b.i.d.
~For all patients:
~• Dose reductions as required based on adverse events."
12062047|NCT00099047|Drug|celecoxib|Given PO
12062048|NCT00099047|Drug|placebo|Given PO
12062049|NCT00099047|Other|laboratory biomarker analysis|Correlative studies
12062050|NCT00099021|Drug|pioglitazone hydrochloride|Given PO
12062051|NCT00099008|Dietary Supplement|Genistein|oral Genistein twice daily on days 1-84
12062052|NCT00099008|Dietary Supplement|Placebo|oral Placebo twice daily on days 1-84
12062053|NCT00098995|Drug|cisplatin|
12062054|NCT00098995|Drug|tirapazamine|
12062055|NCT00098995|Radiation|brachytherapy|
12062056|NCT00098995|Radiation|radiation therapy|
12062057|NCT00098982|Drug|bortezomib|
12062058|NCT00098982|Drug|fluorouracil|
12062059|NCT00098982|Drug|leucovorin calcium|
12062060|NCT00098982|Drug|oxaliplatin|
12062061|NCT00098969|Drug|resveratrol|
12062062|NCT00098956|Drug|topotecan hydrochloride|Given IV
12062063|NCT00098956|Drug|7-hydroxystaurosporine|Given IV
12062064|NCT00098943|Biological|CNGRC peptide-TNF alpha conjugate|
12062065|NCT00098917|Drug|autologous tumor cell vaccine|
12062066|NCT00098917|Drug|therapeutic autologous dendritic cells|
12062067|NCT00098917|Procedure|adjuvant therapy|
12062068|NCT00098917|Procedure|biological therapy|
12062069|NCT00098917|Procedure|conventional surgery|
12062070|NCT00098917|Procedure|surgery|
12062071|NCT00098917|Procedure|tumor cell derivative vaccine|
12062072|NCT00098917|Procedure|vaccine therapy|
12062073|NCT00098891|Drug|entinostat|Given orally
12062074|NCT00098891|Drug|isotretinoin|Given orally
12062075|NCT00098878|Drug|carboplatin|
12062076|NCT00098865|Drug|temozolomide|The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
12062158|NCT00098423|Drug|tanespimycin|Given IV
12062159|NCT00098423|Drug|cytarabine|Given IV
12062077|NCT00098865|Drug|thalidomide|Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.
12062078|NCT00098852|Drug|rosiglitazone maleate|
12062079|NCT00098839|Drug|L-asparaginase|Given IM
12062080|NCT00098839|Drug|doxorubicin hydrochloride|Given IV
12062081|NCT00098839|Drug|therapeutic hydrocortisone|40 mg/m2/day PO divided BID or TID
12062082|NCT00098839|Drug|vincristine sulfate|Given IV
12062083|NCT00098839|Biological|epratuzumab|Given IV
12062084|NCT00098839|Drug|cytarabine|Given IT
12062085|NCT00098839|Drug|prednisone|Given orally
12062086|NCT00098839|Drug|pegaspargase|Given IM
12062087|NCT00098839|Drug|dexrazoxane hydrochloride|Given IV
12062088|NCT00098839|Drug|methotrexate|Given IT
12062089|NCT00098839|Drug|etoposide|Given IV
12062090|NCT00098839|Drug|cyclophosphamide|Given IV
12062091|NCT00098839|Drug|leucovorin calcium|Given IV
12062092|NCT00098839|Biological|filgrastim|Given SC
12062093|NCT00098826|Drug|ispinesib|Given IV
12062094|NCT00098826|Other|laboratory biomarker analysis|Correlative studies
12062095|NCT00098826|Other|pharmacological study|Correlative studies
12062096|NCT00098813|Drug|romidepsin|Given IV
12062097|NCT00098813|Other|laboratory biomarker analysis|Correlative studies
12062098|NCT00098813|Procedure|positron emission tomography|Correlative studies
12062099|NCT00098800|Drug|fenretinide|
12062100|NCT00098787|Biological|bevacizumab|Given IV
12062101|NCT00098787|Drug|fluorouracil|Given IV
12062102|NCT00098787|Drug|irinotecan hydrochloride|Given IV
12062103|NCT00098787|Drug|leucovorin calcium|Given IV
12062104|NCT00098787|Drug|Oxaliplatin|Given IV
12062105|NCT00098774|Biological|filgrastim|5 mcg/kg subQ injection daily Day 14 until ANC > or = 500 uL for 2 days or 1500 uL for 1 day (Cycle 6)
12062106|NCT00098774|Biological|rituximab|375 mg/sq m IV infusion (max rate of 400 mg/hr) on Days 3, 10, 17, & 24 of Cycle 1 nad Days 3 & 10 of Cycle 2
12062107|NCT00098774|Drug|cytarabine|2 g/sq m IV infusion over 2 hours q 12 hrs x 8 doses Days 1-4 of Cycle 6
12062108|NCT00098774|Drug|etoposide|5 mg/kg IV infusion over 12 hrs q 12 hrs x 8 doses Days 1-4 of Cycle 6
12062109|NCT00098774|Drug|leucovorin calcium|100 mg/sq m IV infusion q 6 hrs starting 24 hrs after ea MTX dose until serum MTX < or = 0.05uM Cycles 1-5.
12062110|NCT00098774|Drug|methotrexate|8 g/sq m IV infusion over 4 hrs Days 1 & 15 Cycles 1, 2, & 3; Day 15 Cycle 4 and Day 1 Cycle 5.
12062111|NCT00098774|Drug|temozolomide|150 mg/sq m PO Days 7-11 Cycles 1-5.
12062112|NCT00098761|Drug|laromustine|This is a dose escalation study. Participants receive 20, 30, 45, 60, 78, 103, 137, 182, or 242 mg/m2/day intravenously over 30 minutes for 5 consecutive days every 6 weeks up to 48 weeks.
12062113|NCT00098748|Drug|Optimized Background Therapy (OBT)|OBT (3-6 drugs based on treatment history and resistance testing)
12062114|NCT00098748|Drug|maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken once daily
12062115|NCT00098748|Drug|Optimized Background Therapy (OBT)|OBT (3-6 drugs based on treatment history and resistance testing)
12062116|NCT00098748|Drug|maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken twice daily
12062117|NCT00098748|Drug|Optimized Background Therapy (OBT)|OBT (3-6 drugs based on treatment history and resistance testing)
12062118|NCT00098735|Drug|FTY720|
12062119|NCT00098722|Drug|Maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
12062120|NCT00098722|Drug|optimized background therapy|[OBT (3-6 drugs based on treatment history and resistance testing)]
12062121|NCT00098722|Drug|Maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken twice daily
12062122|NCT00098722|Drug|optimized background therapy|[OBT (3-6 drugs based on treatment history and resistance testing)]
12062123|NCT00098722|Drug|optimized background therapy|[OBT (3-6 drugs based on treatment history and resistance testing)]
12062124|NCT00098709|Device|Fetal pulse oximeter|
12062125|NCT00098683|Drug|amifostine trihydrate|
12062126|NCT00098670|Biological|alemtuzumab|Given SC
12062127|NCT00098670|Biological|rituximab|Given IV
12062128|NCT00098670|Drug|fludarabine phosphate|Given IV
12062129|NCT00098631|Drug|lapatinib ditosylate|Given orally
12062130|NCT00098631|Other|laboratory biomarker analysis|Correlative studies
12062131|NCT00098618|Drug|sorafenib tosylate|Given orally
12062132|NCT00098618|Biological|recombinant interferon alfa|Given orally
12062133|NCT00098618|Other|laboratory biomarker analysis|Correlative studies
12062134|NCT00098605|Drug|lapatinib ditosylate|Given orally
12062135|NCT00098605|Other|laboratory biomarker analysis|Correlative studies
12062136|NCT00098605|Procedure|quality-of-life assessment|Ancillary studies
12062137|NCT00098605|Other|questionnaire administration|Ancillary studies
12062138|NCT00098579|Drug|alvocidib|Given IV
12062139|NCT00098579|Drug|doxorubicin hydrochloride|Given IV
12062140|NCT00098553|Drug|everolimus|
12062141|NCT00098540|Drug|sorafenib tosylate|Given orally
12062142|NCT00098540|Other|laboratory biomarker analysis|Correlative studies
12062143|NCT00098527|Drug|romidepsin|Given IV
12062144|NCT00098527|Other|laboratory biomarker analysis|Correlative studies
12062145|NCT00098514|Drug|talotrexin ammonium|
12062146|NCT00098501|Drug|pelitinib|
12062147|NCT00098501|Drug|temsirolimus|Given PO
12062148|NCT00098488|Drug|tanespimycin|Given IV
12062149|NCT00098488|Biological|rituximab|Given IV
12062150|NCT00098475|Drug|Dexamethasone|Given PO
12062151|NCT00098475|Other|Laboratory Biomarker Analysis|Optional correlative studies
12062152|NCT00098475|Drug|Lenalidomide|Given PO
12062153|NCT00098475|Drug|Thalidomide|Given PO
12062154|NCT00098462|Drug|gefitinib|
12062155|NCT00098462|Drug|sirolimus|
12062156|NCT00098436|Drug|laromustine|
12062157|NCT00098436|Drug|temozolomide|
12062160|NCT00098397|Drug|romidepsin|Given IV
12062161|NCT00098397|Other|laboratory biomarker analysis|Optional correlative studies
12062162|NCT00098384|Drug|rifaximin|
12062163|NCT00098371|Drug|alvocidib|
12062164|NCT00098358|Drug|Zileuton|
12062165|NCT00098345|Drug|ZD6474 (vandetanib)|oral once daily tablet
12062166|NCT00098332|Drug|forodesine hydrochloride|
12062167|NCT00098319|Drug|Folic acid (0.4mg vs. 4.0mg)|
12062168|NCT00098306|Drug|Maraviroc (UK-427,857)|Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
12062169|NCT00098306|Drug|Optimized Background Therapy|Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
12062170|NCT00098306|Drug|Optimized Background Therapy|Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
12062171|NCT00098306|Drug|Placebo|Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
12062172|NCT00098306|Drug|Optimized Background Therapy|Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment.
12062173|NCT00098293|Drug|Maraviroc + Zidovudine/Lamivudine|maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
12062174|NCT00098293|Drug|Efavirenz + Zidovudine/Lamivudine|efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
12062175|NCT00098293|Drug|Maraviroc (UK-427,857) + Zidovudine/Lamivudine|maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
12062176|NCT00098280|Drug|Eculizumab|
12062177|NCT00098254|Drug|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
12062178|NCT00098241|Drug|Certican|
12062179|NCT00098228|Drug|QAB149|
12062180|NCT00098215|Behavioral|Pediatric residency training on tobacco|
12062181|NCT00098202|Drug|Low phytic acid maize|
12062182|NCT00098202|Drug|Zinc|
12062183|NCT00098163|Biological|ALVAC-HIV vCP1521|One 1-ml dose of HIV-1 vaccine administered after birth on or before Day 3 and at weeks 4, 8, and 12.
12062184|NCT00098163|Biological|ALVAC HIV-1 vCP1521|One 1-ml dose of HIV-1 vaccine placebo administered after birth on or before Day 3 and at Weeks 4, 8, and 12.
12062185|NCT00098137|Drug|Olmesartan|
12062186|NCT00098124|Drug|milnacipran hydrochloride|
12062187|NCT00098111|Drug|azathioprine|
12062188|NCT00098098|Biological|rBV A/B|
12062189|NCT00098085|Biological|HSPPC-96|
12062190|NCT00098072|Procedure|Heart Catheterization|Heart Catheterization and collection of samples
12062191|NCT00098059|Drug|Famciclovir|Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
12062192|NCT00098046|Drug|famciclovir|
12062193|NCT00098033|Drug|clofarabine|
12062194|NCT00098020|Drug|Isotretinoin|
12062195|NCT00098007|Drug|Everolimus (Certican)|
12062196|NCT00097981|Drug|Thalidomide|Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.
12062197|NCT00097981|Drug|Dexamethasone|Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.
12062198|NCT00097981|Drug|DOXIL|DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.
12062199|NCT00097968|Drug|everolimus|
12062200|NCT00097955|Drug|aliskiren|
12062201|NCT00097942|Drug|memantine HCl|
12062202|NCT00097929|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months|
12062203|NCT00097916|Drug|memantine HCl|
12062204|NCT00097903|Drug|Karenitecin (BNP1350)|Phase 1 study,dose-escalation design
12062205|NCT00097890|Drug|Replagal (Agalsidase Alfa)|
12062206|NCT00097890|Drug|Replagal|
12062207|NCT00097877|Drug|biphasic insulin aspart|
12062208|NCT00097877|Drug|insulin glargine|
12062209|NCT00097851|Drug|docetaxel|
12062210|NCT00097851|Drug|PI-88|
12062211|NCT00097838|Biological|AVX101|Alphavirus replicon particle vaccine expressing HIV Gag antigen
12062212|NCT00097838|Other|placebo|phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose
12062213|NCT00097825|Drug|Zoledronic Acid|
12062214|NCT00097812|Drug|zoledronic acid|
12062215|NCT00097799|Drug|Tipranavir|500 mg twice daily
12062216|NCT00097799|Drug|Ritonavir|200 mg twice daily
12062217|NCT00097786|Drug|Valsartan 160 mg + nateglinide 60 mg|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
12062269|NCT00097344|Drug|Aromatase inhibition|
12062270|NCT00097344|Drug|Estrogen receptor blocker|
12062271|NCT00097344|Procedure|Hormone therapy|
12062272|NCT00097344|Procedure|Endocrine therapy|
12062218|NCT00097786|Drug|Valsartan 160 mg + nateglinide placebo|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
12062219|NCT00097786|Drug|Nateglinide 60 mg + valsartan placebo|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
12062220|NCT00097786|Drug|Valsartan placebo + nateglinide placebo|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
12062221|NCT00097773|Drug|Tobramycin solution for inhalation (TOBI)|Tobramycin solution for inhalation, 300 mg, administered twice daily for 28 days administered only when quarterly respiratory cultures are found positive for Pa.
12062222|NCT00097773|Drug|Oral placebo|Oral placebo for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive placebo, twice daily.
12062223|NCT00097773|Drug|Oral ciprofloxacin|Oral ciprofloxacin for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive oral ciprofloxacin, 15-20 mg/kg/dose, twice daily.
12062224|NCT00097760|Drug|Natalizumab|Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
12062225|NCT00097760|Drug|Natalizumab|Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
12062226|NCT00097760|Drug|Placebo|Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
12062227|NCT00097747|Drug|Placebo|
12062228|NCT00097747|Drug|peginesatide|
12062229|NCT00097734|Drug|ertapenem|
12062230|NCT00097721|Drug|E7389|The first cohort of subjects were to receive E7389 1.4 mg/m^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.
12062231|NCT00097708|Drug|experimental anti-anxiety drug|
12062232|NCT00097695|Drug|Icatibant|30 mg (3mL) subcutaneous icatibant injection in the abdominal region
12062233|NCT00097695|Drug|Placebo|Solution for injection, matched to study drug Single dose: 3 mL
12062234|NCT00097669|Drug|Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo|multivitamin
12062235|NCT00097669|Other|Placebo|
12062236|NCT00097656|Other|multi-center, randomized, controled periodontal therapy|periodontal therapy
12062237|NCT00097643|Behavioral|exercise|
12062238|NCT00097643|Behavioral|health promotion|
12062239|NCT00097630|Procedure|SAT: Spontaneous Awakening Trial|
12062240|NCT00097630|Procedure|SBT: Spontaneous Breathing Trial|
12062241|NCT00097604|Dietary Supplement|Valerian root extract|Valerian root extract, 100 mg softgels, 3 softgels each night for 2 weeks, 30 minutes before bedtime
12062242|NCT00097591|Drug|Prasugrel|Administered orally
12062243|NCT00097591|Drug|Clopidogrel|Administered orally
12062244|NCT00097539|Biological|Somatrem|
12062245|NCT00097539|Biological|Somatropin|
12062246|NCT00097500|Drug|exenatide|subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
12062247|NCT00097500|Drug|Insulin glargine|subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
12062248|NCT00097500|Drug|Metformin|Patients usual dosage
12062249|NCT00097474|Drug|Hydrocortisone|Hydrocortisone will be given alone or in combination with Melatonin to see if symptoms of jet lag are alleviated
12062250|NCT00097474|Drug|Melatonin|Melatonin will be given alone or in combination with Hydrocortisone to see if symptoms of jet lag are alleviated
12062251|NCT00097474|Drug|Placebo|Placebo
12062252|NCT00097448|Drug|prednisone|Oral, 19 days
12062253|NCT00097448|Drug|methylprednisolone sodium succinate|Four intratympanic injections delivered to the middle ear over 2 weeks
12062254|NCT00097435|Drug|Albuferon|
12062255|NCT00097435|Drug|Ribavirin|
12062256|NCT00097422|Drug|OPT-80|
12062257|NCT00097409|Drug|Ispinesib|
12062258|NCT00097396|Biological|rF1V vaccine|
12062259|NCT00097383|Drug|ALIMTA plus Epirubicin|
12062260|NCT00097370|Drug|mepolizumab|Study Drug
12062261|NCT00097357|Drug|Apixaban|Tablets, Oral, 12 +/- 2 days
12062262|NCT00097357|Drug|Enoxaparin|Injection, SQ, Q12H, 12 +/- 2 days
12062263|NCT00097357|Drug|Warfarin|Tablets, Oral, QD, 12 +/- 2 days
12062264|NCT00097357|Drug|Enoxaparin Placebo|Injection, SQ, BID, 12 +/- 2 days
12062265|NCT00097357|Drug|Apixaban Placebo|Tablets, Oral, BID, 12 +/- 2 days
12062266|NCT00097344|Drug|Atamestane|
12062267|NCT00097344|Drug|Toremifene|
12062268|NCT00097344|Drug|Letrozole|
12062273|NCT00097344|Procedure|Antiestrogen therapy|
12062274|NCT00097331|Drug|SB683699|
12062275|NCT00097318|Drug|Interferon beta-1a|
12062276|NCT00097305|Behavioral|Body-Oriented Therapy|
12062277|NCT00097305|Behavioral|Standardized Massage Therapy|
12062278|NCT00097279|Drug|biphasic insulin aspart|
12062279|NCT00097279|Drug|pioglitazone|
12062280|NCT00097279|Drug|metformin|
12062281|NCT00097266|Drug|Placebo|Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
12062282|NCT00097266|Drug|Aripiprazole|Tablets, oral, 15-30 mg, once daily, 12 weeks.
12062283|NCT00097266|Drug|Haloperidol|Capsule, oral, 5-15 mg, once daily, 12 weeks.
12062284|NCT00097253|Behavioral|Exposure to relaxant and stimulant odors|A yellow-tinted cotton ball containing 100 ml of the essential oil or distilled water was taped between the nose and upper lip on top of a piece of surgical tape; use of the barrier tape avoided percutaneous absorption . This method provided continuous and uniform exposure across subjects that would not have been possible with ambient room inhalation, and helped maintain experimenter blindness.
12062285|NCT00097227|Biological|Cetuximab|"(Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion.
~A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B."
12062286|NCT00097227|Drug|Carboplatin|(AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.
12062287|NCT00097227|Drug|Paclitaxel|225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.
12062288|NCT00097214|Drug|Carboplatin|AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8.
12062289|NCT00097214|Biological|Cetuximab|400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8.
12062290|NCT00097188|Drug|rituximab|
12062291|NCT00097162|Procedure|Anodal stimulation|
12062292|NCT00097149|Procedure|Systematic pediatric care|
12062293|NCT00097123|Drug|Misoprostol|
12062294|NCT00097110|Drug|Vitamin C and E|
12062295|NCT00097097|Procedure|Neonatal Resuscitation|
12062296|NCT00097084|Drug|insulin detemir|
12062297|NCT00097084|Drug|insulin glargine|
12062298|NCT00097084|Drug|insulin aspart|
12062299|NCT00097071|Drug|insulin lispro|
12062300|NCT00097071|Drug|insulin aspart|
12062301|NCT00097045|Drug|omega interferon|
12062302|NCT00097045|Drug|Ribavirin|
12062303|NCT00097032|Drug|risperidone; quetiapine|
12062304|NCT00097019|Drug|bevacizumab|
12062305|NCT00096993|Drug|Placebo|Placebo was provided as a single-use formulation for infusion.
12062306|NCT00096993|Drug|Gemcitabine|Gemcitabine was provided as a solution for infusion.
12062307|NCT00096993|Drug|Pertuzumab|Pertuzumab was provided as a single-use formulation for infusion.
12062308|NCT00096980|Drug|Raptiva (efalizumab)|
12062309|NCT00096967|Drug|Avastin (bevacizumab)|
12062310|NCT00096954|Drug|omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
12062311|NCT00096954|Drug|placebo|The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
12062312|NCT00096941|Drug|Pertuzumab|Pertuzumab was supplied as a single-use liquid formulation.
12062313|NCT00096915|Drug|Darbepoetin Alfa|"QM administration for 32 weeks, allowable doses:
~15, 20, 30, 40, 50, 60, 80, 100, 150, 200, 300, 400, 500, 600 and 800 mcg"
12062314|NCT00096902|Procedure|Tilt table test|
12062315|NCT00096863|Drug|Ziprasidone|
12062316|NCT00096863|Drug|Haloperidol|
12062317|NCT00096863|Other|Placebo|
12062318|NCT00096850|Drug|Atazanavir|From Days 9 to 19, participants will receive a 300 mg tablet orally daily. From Days 20 to 27, participants will receive a 400 mg tablet orally daily.
12062319|NCT00096850|Drug|Rifampin|From Days 1 to 27, participants will receive a 600 mg tablet orally daily.
12062320|NCT00096850|Drug|Ritonavir|From Days 9 to 19, participants will receive a 100 mg tablet orally daily. From Days 20 to 27, participants will receive a 100 mg tablet orally twice daily.
12062321|NCT00096837|Drug|Motexafin Gadolinium Injection|
12062322|NCT00096824|Behavioral|Neurological assessment|All participants will undergo neurological examinations and neuropsychological assessments.
12062323|NCT00096811|Drug|Entecavir|Tablets, Oral, 1 mg once daily. Until subject achieves a complete response or until ETV approved and marketed in a given country.
12062324|NCT00096798|Drug|Ethyl-eicosapentanoic acid (ethyl-EPA)|
12062325|NCT00096785|Drug|entecavir|Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks
12062326|NCT00096785|Drug|adefovir|Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks
12062327|NCT00096759|Behavioral|Tai Chi Chih|
12062328|NCT00096759|Behavioral|Relaxation training|
12062329|NCT00096746|Drug|LPV/RTV + 2NRTIs|Tablets, Oral, Variable, Twice daily, 48 weeks.
12062330|NCT00096746|Drug|LPV/RTV + 2NRTIs|Tablets, Oral, Variable, Twice daily, 48 weeks.
12062331|NCT00096720|Drug|levodopa|
12062332|NCT00096720|Drug|Mirapex (pramipexole)|
12062333|NCT00096720|Procedure|[123I]ß-CIT and SPECT imaging|
12062334|NCT00096707|Drug|2-deoxy-D-glucose (2DG)|
12062335|NCT00096694|Device|Levonorgestrel-releasing intrauterine device (IUD)|
12062336|NCT00096668|Drug|TOCOSOL(R) Paclitaxel|
12062337|NCT00096655|Drug|Infliximab|
12062338|NCT00096642|Behavioral|Cognitive Behavioral Therapy|Cognitive behaviour versus standard care
12062339|NCT00096629|Biological|human prostate-specific membrane antigen plasmid DNA vaccine|
12062340|NCT00096629|Biological|mouse prostate-specific membrane antigen plasmid DNA vaccine|
12062341|NCT00096616|Drug|Combivent® CFC MDI|
12062342|NCT00096616|Drug|Albuterol HFA MDI|
12062343|NCT00096603|Drug|Raptiva (efalizumab)|
12062344|NCT00096590|Other|coagulation study|
12062345|NCT00096590|Other|immunoenzyme technique|
12062346|NCT00096590|Other|laboratory biomarker analysis|
12062347|NCT00096590|Other|physiologic testing|
12062348|NCT00096590|Procedure|study of high risk factors|
12062349|NCT00096551|Drug|Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM)|
12062350|NCT00096551|Drug|Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM)|
12062351|NCT00096551|Drug|Recombinant Fowlpox-GM-CSF|
12062352|NCT00096538|Drug|valganciclovir|
12062353|NCT00096525|Drug|lenalidomide|
12062354|NCT00096512|Drug|sorafenib tosylate|Given orally
12062355|NCT00096512|Other|laboratory biomarker analysis|Correlative studies
12062356|NCT00096499|Drug|ispinesib|Given IV
12062357|NCT00096499|Other|pharmacological study|Correlative studies
12062358|NCT00096499|Other|laboratory biomarker analysis|Correlative studies
12062359|NCT00096486|Drug|everolimus|
12062360|NCT00096486|Drug|gefitinib|
12062361|NCT00096473|Drug|Donepezil hydrochloride|
12062362|NCT00096460|Drug|Cyclophosphamide and Rituximab|Prior to undergoing HSCT, all patients will receive Cyclophosphamide 4 gm/m2 with Rituximab 375 mg/m2 x 2 doses and G-CSF support.
12062363|NCT00096460|Drug|Filgrastim|Autologous HSCT patients will receive 10 mcg/kg/day and allogeneic HSCT patients will receive 5 mcg/kg/day subcutaneous (SQ) or intravenous (IV) starting 2 days after the initiation of Cyclophosphamide.
12062364|NCT00096460|Radiation|Chemotherapy or Radiation therapy|"Chemotherapy - BCNU 15 mg/kg IV x 1 dose to be administered over 2 hours on Day -6 pre-HSCT. VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4.
~Radiation - administered at a rate of < 20 cGy/min in one of the following doses; 120 cGy/fraction are administered at no less than 4-hour intervals three times/day or 2 times/day for a total of 10 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5), or doses of 150 cGy/fraction twice daily for a total of 8 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5). VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4 pre-HSCT.
~Cyclophosphamide 100 mg/kg IV x 1 dose to be administered over 2 hours on Day -2 pre-HSCT. G-CSF 5 mcg/kg SQ or IV to start on Day +5 post-HSCT and continue until ANC > 500/mm3 x 3 days."
12062365|NCT00096460|Drug|Non-myeloablative Conditioning regimen|Fludarabine 30 mg/m2 IV x 3 doses total to be administered daily over 30 minutes on Days -6, -5 and -4 pre-HSCT. Cyclophosphamide 750 mg/m IV x 3 doses total to be administered daily over 1 hour on Days -6, -5 and -4 pre-HSCT. Administer cyclophosphamide approximately 4 hours after start of fludarabine infusion. Rituximab 375 mg/m2 IV x 4 doses total to be administered on Days -13 and -6 pre HSCT and Days +1 and +8 post HSCT.
12062366|NCT00096460|Procedure|Allogeneic transplant|Infusion of G-CSF mobilized allogeneic hematopoietic stem cells
12062367|NCT00096460|Procedure|Autologous transplant|Infusion of G-CSF mobilized autologous hematopoietic stem cells
12062368|NCT00096460|Drug|Rituximab maintenance therapy|"Patients must have sufficiently recovered from autologous HSCT in order to receive rituximab maintenance therapy as specified below:
~Dose #1: Day +42 post-autologous HSCT Dose #2: Day +49 post-autologous HSCT Dose #3: Day +56 post-autologous HSCT Dose #4: Day +63 post-autologous HSCT"
12062369|NCT00096460|Drug|GVHD Prophylaxis|Tacrolimus 0.09 mg/kg/day PO, based on body weight formulas will start on Day -2 and continue until Day +90 post-HSCT. Tacrolimus (or cyclosporine, if applicable) will be given orally in a twice-daily divided dose. Methotrexate 5 mg/m2 Intravenous Pyelogram (IVP) will be administered on Days +1, +3 and +6 post-HSCT.
12062370|NCT00096447|Drug|lapatinib ditosylate|
12062371|NCT00096434|Drug|sorafenib tosylate|Given orally
12062372|NCT00096434|Other|laboratory biomarker analysis|Correlative studies
12062373|NCT00096421|Behavioral|Tight control of blood glucose levels|
12062374|NCT00096421|Behavioral|Conventional control of glucose levels|
12062375|NCT00096408|Procedure|Total Abdominal Hysterectomy|For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.
12062376|NCT00096408|Procedure|Total Laparoscopic Hysterectomy|The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.
12062377|NCT00096395|Drug|gemcitabine hydrochloride|Given IV
12062378|NCT00096395|Drug|sorafenib tosylate|Given orally
12062379|NCT00096395|Other|laboratory biomarker analysis|Correlative studies
12062380|NCT00096382|Biological|aldesleukin|high dose: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days (maximum 5 doses) or low dose: 250,000 IU/kg subcutaneously daily for 5 days, after a two day rest, 125,000 IU/kg subcutaneously daily for 5 days for five weeks (2 days rest per week)
12062381|NCT00096382|Biological|filgrastim|10 mcg/kg/day daily subcutaneously until neutrophil count >1x10^9/1.
12062382|NCT00096382|Biological|therapeutic tumor infiltrating lymphocytes|Lymphocytes that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
12062383|NCT00096382|Drug|cyclophosphamide|60 mg/kg/day x 2 days intravenously over 1 hour
12062384|NCT00096382|Drug|fludarabine phosphate|25 mg/m^2/day intravenous piggyback daily over 15-20 minutes for 5 days
12062385|NCT00096382|Radiation|radiation therapy|Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
12062386|NCT00096369|Drug|tamoxifen citrate|
12062387|NCT00096356|Dietary Supplement|CoQ10 & Vitamin E|
12062388|NCT00096356|Dietary Supplement|Placebo & Vitamin E|
12062389|NCT00096343|Drug|carboplatin|
12062390|NCT00096343|Drug|paclitaxel|
12062391|NCT00096330|Dietary Supplement|dietary intervention|oral folic acid supplementation once daily on days 57-84
12062392|NCT00096330|Dietary Supplement|folic acid|oral folic acid supplementation once daily on days 1-56.
12062393|NCT00096317|Drug|ixabepilone|
12062394|NCT00096317|Drug|ketoconazole|
12062395|NCT00096304|Drug|docetaxel|
12062396|NCT00096304|Drug|epirubicin hydrochloride|
12062397|NCT00096291|Other|Doxorubicin followed by Paclitaxel|"Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy:
~Doxorubicin followed by Paclitaxel Paclitaxel followed by Doxorubicin"
12062398|NCT00096291|Other|Paclitaxel followed by Doxorubicin|"Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy:
~Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin"
12062399|NCT00096278|Biological|Bevacizumab|Given IV
12062400|NCT00096278|Drug|Fluorouracil|Given IV
12062401|NCT00096278|Drug|Leucovorin Calcium|Given IV
12062402|NCT00096278|Drug|Oxaliplatin|Given IV
12062403|NCT00096265|Radiation|3-Dimensional Conformal Radiation Therapy|Patients undergo radiation therapy once daily for approximately 3 weeks
12062404|NCT00096265|Drug|Erlotinib Hydrochloride|Given orally
12062405|NCT00096265|Radiation|Stereotactic Radiosurgery|Patients undergo surgery after radiation therapy
12062406|NCT00096265|Drug|Temozolomide|Given orally
12062407|NCT00096239|Drug|CP-547,632|
12062408|NCT00096226|Drug|Induction Carboplatin|
12062409|NCT00096226|Drug|Induction Paclitaxel|
12062410|NCT00096226|Procedure|Resection|
12062411|NCT00096226|Drug|Consolidation Carboplatin|
12062412|NCT00096226|Radiation|Radiation Therapy|
12062413|NCT00096226|Drug|Consolidation Paclitaxel|
12062414|NCT00096213|Procedure|conventional surgery|surgery
12062415|NCT00096200|Drug|Carboplatin|Given IV
12062416|NCT00096200|Drug|Paclitaxel|Given IV
12062417|NCT00096200|Drug|Sorafenib Tosylate|Given orally
12062418|NCT00096187|Drug|pemetrexed disodium|
12062419|NCT00096174|Biological|cetuximab C225|400 mg/m^2 IV over 120 minutes on Day 1, 250 mg/m^2 IV over 60 minutes on Day 8, then weekly
12062420|NCT00096174|Drug|cisplatin|75 mg/m^2 IV over 30-60 minutes starting day 15 every 3 weeks * 3 (Days 1, 22, and 43 of radiation therapy (RT))
12062421|NCT00096174|Radiation|radiation therapy|RT 70 Gy / 35 starting Day 15, 200cGy / d * 7 weeks (35 fractions)
12062422|NCT00096161|Drug|Cyclosporine|Given PO
12062423|NCT00096161|Drug|Mycophenolate Mofetil|Given PO
12062424|NCT00096161|Drug|Pentostatin|Given IV
12062425|NCT00096161|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
12062426|NCT00096148|Drug|idarubicin|Given IV
12062427|NCT00096148|Drug|cytarabine|Given IV
12062428|NCT00096148|Biological|bevacizumab|Given IV
12062429|NCT00096148|Other|laboratory biomarker analysis|Correlative studies
12062430|NCT00096135|Biological|filgrastim|given subcutaneously (SC)
12062431|NCT00096135|Drug|cyclophosphamide|IV over 15-30 minutes
12062432|NCT00096135|Drug|cytarabine|IV over 3 hours twice daily
12062433|NCT00096135|Drug|daunorubicin hydrochloride|IV over 15 minutes
12062434|NCT00096135|Drug|dexamethasone|oral twice daily
12062435|NCT00096135|Drug|etoposide|IV over 1 hour
12062436|NCT00096135|Drug|leucovorin calcium|rescue IV over 24 hours
12062437|NCT00096135|Drug|mercaptopurine|oral
12062438|NCT00096135|Drug|methotrexate|intramuscularly (IM)
12062439|NCT00096135|Drug|pegaspargase|intramuscularly (IM)
12062440|NCT00096135|Drug|therapeutic hydrocortisone|
12062441|NCT00096135|Drug|vincristine sulfate|given IV
12062442|NCT00096135|Radiation|radiation therapy|Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
12062443|NCT00096122|Drug|cytarabine|Given IV
12062444|NCT00096122|Drug|idarubicin|Given IV
12062445|NCT00096122|Drug|tipifarnib|Given orally
12062446|NCT00096109|Drug|tanespimycin|Given IV
12062447|NCT00096109|Other|laboratory biomarker analysis|Correlative studies
12062448|NCT00096096|Drug|mycophenolate mofetil|
12062449|NCT00096096|Drug|tacrolimus|
12062450|NCT00096083|Drug|isolated perfusion|
12062451|NCT00096083|Drug|melphalan|
12062452|NCT00096070|Radiation|radiation therapy|Undergo radiation therapy
12062453|NCT00096070|Drug|oxaliplatin|Given IV
12062454|NCT00096070|Drug|fluorouracil|Given IV
12062455|NCT00096070|Drug|gemcitabine hydrochloride|Given IV
12062456|NCT00096057|Biological|monoclonal antibody HuHMFG1|
12062457|NCT00096044|Biological|rituximab|IV
12062458|NCT00096044|Drug|lenalidomide|Oral
12062459|NCT00096031|Biological|cetuximab|1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
12062460|NCT00096018|Drug|fludarabine phosphate|Given IV
12062461|NCT00096018|Drug|thalidomide|Orally
12062462|NCT00096005|Drug|tanespimycin|Given IV
12062463|NCT00096005|Drug|bortezomib|Given IV
12062464|NCT00096005|Other|laboratory biomarker analysis|Correlative studies
12062465|NCT00095992|Drug|ispinesib|SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks
12062466|NCT00095979|Drug|ixabepilone|Given IV
12062467|NCT00095966|Drug|sorafenib tosylate|Given orally
12062468|NCT00095966|Drug|gemcitabine hydrochloride|Given IV
12062469|NCT00095953|Drug|ispinesib|SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.
12062470|NCT00095940|Drug|lapatinib ditosylate|Given orally
12062471|NCT00095940|Procedure|therapeutic conventional surgery|Undergo surgery
12062472|NCT00095940|Other|laboratory biomarker analysis|Correlative studies
12062473|NCT00095940|Other|pharmacological study|Correlative studies
12062474|NCT00095940|Procedure|positron emission tomography|Correlative studies
12062475|NCT00095940|Procedure|magnetic resonance imaging|Correlative studies
12062476|NCT00095927|Drug|Amifostine|Given subcutaneously
12062477|NCT00095927|Drug|Carboplatin|Given IV
12062478|NCT00095927|Drug|Paclitaxel|Given IV
12062479|NCT00095927|Radiation|radiation|Given once daily for 4 weeks and then twice daily for 2 weeks.
12062480|NCT00095914|Drug|paclitaxel|
12062481|NCT00095914|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12062484|NCT00095888|Drug|gemcitabine hydrochloride|Given IV
12062485|NCT00095888|Other|laboratory biomarker analysis|Correlative studies
12062486|NCT00095888|Other|pharmacological study|Correlative studies
12062487|NCT00095875|Drug|carboplatin|Given IV
12062488|NCT00095875|Drug|cisplatin|Given IV
12062489|NCT00095875|Drug|docetaxel|Given IV
12062490|NCT00095875|Drug|fluorouracil|Given IV
12062491|NCT00095862|Biological|allogeneic GM-CSF-secreting breast cancer vaccine|
12062492|NCT00095862|Biological|recombinant interferon alfa|
12062493|NCT00095862|Drug|cyclophosphamide|
12062494|NCT00095836|Drug|Gefitinib|Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
12062495|NCT00095823|Drug|Antidepressant + Placebo|Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
12062496|NCT00095823|Drug|Antidepressant + Aripiprazole|Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
12062497|NCT00095810|Drug|aripiprazole|Tablets, Oral, 1-10mg, Once daily, 6 weeks.
12062498|NCT00095797|Drug|R(+)XK469|Given IV
12062499|NCT00095797|Other|pharmacological study|Correlative studies
12062500|NCT00095797|Other|laboratory biomarker analysis|Optional correlative studies
12062501|NCT00095784|Drug|Decitabine|Given SC
12062502|NCT00095784|Other|Laboratory Biomarker Analysis|Correlative studies
12062503|NCT00095771|Drug|arsenic trioxide|
12062504|NCT00095771|Radiation|radiation therapy|
12062505|NCT00095758|Drug|Antidepressant + Placebo|Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
12062506|NCT00095758|Drug|Antidepressant + Aripiprazole|Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
12062507|NCT00095745|Drug|Antidepressant + Aripiprazole|Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
12062508|NCT00095732|Drug|Liprotamase|Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase)
12062509|NCT00095732|Drug|Placebo|Administered orally in either Size 2 or Size 5 capsules
12062510|NCT00095719|Drug|Aripiprazole|IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts.
12062511|NCT00095719|Drug|Placebo|IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts.
12062512|NCT00095706|Drug|Bevacizumab (drug), Herceptin (drug)|
12062513|NCT00095693|Drug|sorafenib tosylate|Given PO
12062514|NCT00095693|Other|laboratory biomarker analysis|Correlative studies
12062515|NCT00095693|Other|pharmacological study|Correlative studies
12062516|NCT00095693|Radiation|fludeoxyglucose F 18|Correlative studies
12062517|NCT00095693|Procedure|positron emission tomography|Correlative studies
12062518|NCT00095693|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Correlative studies
12062519|NCT00095680|Drug|SCIO-469|two 30-mg capsules three times daily
12062520|NCT00095680|Drug|SCIO-469 and bortezomib|The addition of bortezomib (treatment regimen or bolus) to monotherapy of SCIO-469 or bortezomib combination with SCIO-469 will be dependent upon clinical response or disease progression during the study
12062521|NCT00095667|Drug|lapatinib ditosylate|Given orally
12062522|NCT00095667|Other|laboratory biomarker analysis|Correlative studies
12062523|NCT00095654|Drug|Ramipril|
12062524|NCT00095654|Drug|Rosiglitazone|
12062525|NCT00095641|Drug|capecitabine|
12062526|NCT00095641|Procedure|adjuvant therapy|
12062527|NCT00095641|Procedure|chemotherapy|
12062528|NCT00095628|Drug|ispinesib|Given IV
12062529|NCT00095628|Other|laboratory biomarker analysis|Correlative studies
12062530|NCT00095628|Other|pharmacological study|Correlative studies
12062531|NCT00095589|Genetic|loss of heterozygosity analysis|
12062532|NCT00095589|Genetic|microarray analysis|
12062533|NCT00095589|Genetic|microsatellite instability analysis|
12062534|NCT00095589|Other|cytology specimen collection procedure|
12062535|NCT00095589|Other|laboratory biomarker analysis|
12062536|NCT00095589|Procedure|computed tomography|
12062537|NCT00095589|Procedure|cystoscopy|
12062538|NCT00095576|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)|"Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 adenovirus genomes [ad-vg]/dose).
~This dose is equivalent to 3x10^10 vp/dose used in study V520-016."
12062539|NCT00095576|Drug|Comparator: placebo|Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.
12062540|NCT00095563|Drug|lapatinib ditosylate|Given orally
12062541|NCT00095563|Other|laboratory biomarker analysis|Correlative studies
12062542|NCT00095550|Drug|Irbesartan/HCTZ|Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
12062543|NCT00095550|Drug|Irbesartan monotherapy|Tablets, Oral, 150 mg, Once daily, 12 weeks.
12062544|NCT00095550|Drug|HCTZ monotherapy|Tablets, Oral, 12.5 mg, Once daily, 12 weeks.
12062545|NCT00095537|Drug|panHer|Tablets, Oral, A modified Fibonocci dose escalation system initiated at 100mg and escalating up to 880mg maximum dose (rounded down to 20mg increments based on smallest tablet size); -2 40mg -33%; -1 60mg -40%; 1 100mg --; 2 200mg 100%; 3 320mg 67%; 4 480mg 50%; 5 660mg 40%; 6 880mg 33.3%, Daily, Until DLT or study MTD is reached.
12062546|NCT00095524|Drug|Aripiprazole|
12062547|NCT00095511|Drug|aripiprazole|
12062548|NCT00095498|Drug|placebo|placebo subcutaneous injection
12062549|NCT00095498|Drug|denosumab|For subcutaneous injection
12062550|NCT00095472|Drug|L-NMMA|
12062555|NCT00095433|Drug|rhuFab V2 (ranibizumab)|
12062556|NCT00095420|Behavioral|Social skills training targeting children with autism|Sessions will focus on improving the social skills of autistic children. Thirty-minute sessions will be held twice a week for 6 weeks.
12062557|NCT00095420|Behavioral|Social skills training of peers without autism|Sessions will involve educating the peers of autistic children to increase their acceptance of their autistic peers. Thirty-minute sessions will be held twice a week for 6 weeks.
12062558|NCT00095420|Behavioral|Combination treatment of social skills/education about autism|The combination treatment includes children with and without autism. Sessions will involve social skills training and education about autism to increase acceptance of autistic peers. Training will be conducted twice a week for 6 weeks
12062559|NCT00095420|Behavioral|Usual training|Participants will receive the usual training offered in their local school districts.
12062560|NCT00095394|Drug|Irbesartan/HCTZ|Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
12062561|NCT00095394|Drug|Irbesartan monotherapy|Tablets, Oral, 150 mg, Once daily, 7 weeks.
12062562|NCT00095381|Drug|forodesine hydrochloride (BCX-1777)|
12062563|NCT00095368|Drug|Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)|
12062564|NCT00095355|Drug|Lithium|
12062565|NCT00095355|Drug|Divalproex|
12062566|NCT00095342|Drug|TMI-005|
12062567|NCT00095329|Biological|sirolimus|
12062568|NCT00095316|Drug|Caspofungin|Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.
12062569|NCT00095316|Other|Placebo|Normal saline equivalent to that used to deliver the caspofungin given intravenously as a single daily dose infused over approximately 1 hour for 28 days
12062570|NCT00095303|Behavioral|Brief Strategic Family Therapy (BSFT)|"BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
12062571|NCT00095303|Behavioral|Treatment as Usual|TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
12062572|NCT00095290|Drug|Ramipril + Irbesartan|Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
12062573|NCT00095290|Drug|Ramipril + Placebo|Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
12062574|NCT00095277|Drug|Darbepoetin Alfa|
12062575|NCT00095264|Drug|Darbepoetin Alfa|
12062576|NCT00095251|Drug|Dexmedetomidine|a bolus dose of 1 μg/kg infused over 10 minutes followed by an infusion started at 0.15- 0.45 μg/kg/hr. Dexmedetomidine will be titrated every 10 minutes to achieve set target RASS score. The maximum dexmedetomidine infusion will be 1.5 μg/kg/hr.
12062577|NCT00095251|Drug|Lorazepam|Patients in the lorazepam arm will receive a bolus dose of 1-3 mg followed by an infusion started at 1-3 mg/hr. Lorazepam infusion will be titrated every 10 minutes to achieve set target RASS score. The maximum lorazepam infusion will be 10 mg /hr.
12062578|NCT00095238|Drug|Irbesartan|Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
12062579|NCT00095238|Drug|Placebo|Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
12062580|NCT00095225|Drug|Avastin (bevacizumab)|
12062581|NCT00095225|Drug|Tarceva (erlotinib HCl)|
12062582|NCT00095212|Drug|1 Transdermal Testosterone (Patch)|300 micrograms twice a week
12062583|NCT00095212|Drug|2 Placebo Patch|Placebo patch (0 micrograms of testosterone) applied twice a week
12062584|NCT00095199|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
12062585|NCT00095199|Biological|Cetuximab|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity.
12062586|NCT00095199|Drug|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
12062587|NCT00095186|Drug|Recombinant Human Lactoferrin|
12062588|NCT00095173|Drug|Abatacept|IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).
12062589|NCT00095173|Drug|Placebo|IV infusions, IV, N/A, every 4 weeks, 6 months.
12062590|NCT00095173|Drug|Abatacept|Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly
12062591|NCT00095160|Drug|852A|
12062592|NCT00095147|Drug|Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)|Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.
12062593|NCT00095147|Drug|Infliximab (INF) + MTX, DB|Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.
12062594|NCT00095147|Drug|Placebo (PLA) + MTX, DB|Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.
12062595|NCT00095147|Drug|PLA + MTX switched to ABA+ MTX, DB|Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months
12062596|NCT00095147|Drug|ABA, open-label (OL)|Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
12062597|NCT00095134|Drug|risperidone|
12062598|NCT00095121|Drug|Placebo (PLB)|Matching placebo
12062599|NCT00095121|Drug|Adefovir Dipivoxil (ADV)|10-mg tablet or 2-mg/mL oral suspension
12062600|NCT00095121|Drug|Lamivudine|100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained >= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations.
12062601|NCT00095108|Drug|Recombinant Human Interleukin-21|
12062602|NCT00095095|Device|Lumbar Interbody Fusion|
12062603|NCT00095082|Drug|insulin detemir|
12062604|NCT00095082|Drug|insulin glargine|
12062605|NCT00095082|Drug|insulin aspart|
12062606|NCT00095069|Drug|MK0928, gaboxadol / Duration of Treatment - 1 year|
12062607|NCT00095069|Drug|Comparator: placebo / Duration of Treatment -1 year|
12062608|NCT00095056|Drug|sitagliptin|One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily.
12062609|NCT00095056|Drug|Placebo to Sitagliptin|One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily.
12062610|NCT00095056|Drug|glipizide|One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
12062611|NCT00095056|Drug|Placebo to glipizide|One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
12062612|NCT00095043|Drug|MK0928, gaboxadol|
12062613|NCT00095043|Drug|Comparator: placebo|
12062614|NCT00095030|Drug|muraglitazar|
12062615|NCT00095017|Drug|MK0663, etoricoxib / Duration of Treatment: 4 weeks|
12062616|NCT00095004|Drug|MK0462, rizatriptan benzoate / Duration of Treatment: 1day|
12062617|NCT00095004|Drug|Comparator: placebo / Duration of Treatment: 1 day|
12062618|NCT00094991|Drug|Muraglitazar|
12062619|NCT00094978|Drug|Depsipeptide|
12062620|NCT00094978|Drug|Flavopiridol (alvocidib)|
12062621|NCT00094965|Drug|Oxaliplatin (SR96669)|oxaliplatin in combination with FOLFOX4
12062622|NCT00094926|Drug|Risperdal Consta|25, 37.5 or 50mg IM injections every 2wks for 52wks
12062623|NCT00094926|Drug|placebo|matching placebo IM injections every 2wks for 52wks
12062624|NCT00094900|Drug|IL-1 Trap|
12062625|NCT00094887|Drug|Nitric Oxide|Nitric oxide will be delivered for 4 hours at 80 ppm through a face mask. The dose will then be reduced to 40 ppm for 4 hours. After a total of 8 hours of treatment through face mask, the patient will get 6 mL/puls/breath of NO at 800 ppm or 3 m//pulse/breath, depending on patient weight.
12062626|NCT00094887|Drug|Placebo|Nitrogen gas will be delivered in the same manor as the experimental drug.
12062627|NCT00094874|Procedure|Acupuncture|
12062628|NCT00094861|Drug|Palifermin|
12062629|NCT00094861|Drug|Placebo|
12062630|NCT00094861|Radiation|Radiotherapy|
12062631|NCT00094861|Drug|Paclitaxel|
12062632|NCT00094861|Drug|Carboplatin|
12062633|NCT00094848|Drug|TRAIL-R1 mAb (TRM-1; HGS-ETR1)|
12062634|NCT00094835|Biological|Panitumumab|9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes.
12062635|NCT00094835|Drug|Motesanib diphosphate|Dose-finding with an initial dose of 50 mg once daily and up to 125 mg once daily. 75 mg twice daily was also to be tested.
12062636|NCT00094835|Drug|Paclitaxel|Paclitaxel 200 mg/m^2 administered by IV infusion over 3 hours.
12062637|NCT00094835|Drug|Carboplatin|Carboplatin was administered IV over approximately 30 minutes. Carboplatin was dosed using the glomerular filtration rate (GFR) and Calvert formula to AUC/time curve of 6 mg/mL×min.
12062638|NCT00094822|Other|PI Discretion|PI Discretion
12062639|NCT00094809|Drug|Placebo|Subjects randomized to placebo will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.
12062640|NCT00094809|Drug|Pegfilgrastim|Subjects randomized to pegfilgrastim will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.
12062641|NCT00094796|Procedure|Exercise cardiopulmonary metabolic testing|
12062642|NCT00094796|Procedure|Skeletal muscle biopsy|
12062643|NCT00094796|Procedure|Brachial artery reactivity testing|
12062644|NCT00094783|Procedure|MRI|
12062645|NCT00094770|Drug|sitagliptin (MK0431)|Sitagliptin 100 mg oral tablets of sitagliptin once daily.
12062646|NCT00094770|Drug|Comparator: glipizide|Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
12062647|NCT00094757|Drug|Comparator: sitagliptin 100 mg|sitagliptin 100 mg oral tablet once daily for 54 weeks
12062648|NCT00094757|Drug|Comparator: sitagliptin 200 mg|sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
12062649|NCT00094757|Drug|Comparator: placebo|placebo oral tablet once daily during Phase A (Weeks 0-18)
12062650|NCT00094757|Drug|Comparator: pioglitazone|pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
12062651|NCT00094744|Device|Eye patch|adhesive eye patch used to cover the sound eye
12062652|NCT00094731|Procedure|Memory Training|
12062653|NCT00094718|Biological|WN/DEN4-3'delta30|Live attenuated WN/DEN4-3'delta30 vaccine (one of three doses)
12062654|NCT00094718|Biological|Placebo|Placebo for WN/DEN4-3'delta30 vaccine
12062655|NCT00094705|Biological|rDEN2/4delta30(ME) Vaccine|Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)
12062656|NCT00094705|Biological|Placebo|Placebo for rDEN2/4delta30(ME) vaccine
12062657|NCT00094692|Device|Eye patch|
12062658|NCT00094692|Device|spectacles|
12062659|NCT00094692|Drug|atropine|
12062660|NCT00094679|Device|Eye patch|adhesive patch to cover the sound eye
12062661|NCT00094666|Drug|MK0928, gaboxadol / Duration of Treatment - 6 weeks|
12062662|NCT00094666|Drug|Comparator: placebo / Duration of Treatment - 6 weeks|
12062663|NCT00094653|Drug|MDX-010 (anti-CTLA4) monoclonal antibody|3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
12062664|NCT00094653|Biological|MDX-1379 (gp100) Melanoma Peptide Vaccine|2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
12062665|NCT00094640|Drug|Intramuscular Olanzapine Depot|
12062666|NCT00094627|Drug|gaboxadol|Duration of Treatment - 6 weeks
12062667|NCT00094627|Drug|Comparator: placebo (unspecified)|Duration of Treatment - 6 weeks
12062668|NCT00094614|Drug|Atropine|
12062669|NCT00094575|Procedure|Endovascular Repair|Endovascular Repair
12062670|NCT00094575|Procedure|Standard Open Repair|Standard Open Repair
12062671|NCT00094562|Drug|Fish oil supplement|
12062672|NCT00094549|Drug|olanzapine|
12062673|NCT00094549|Drug|divalproex sodium|
12062674|NCT00094549|Drug|placebo|
12062675|NCT00094536|Device|Extended treatment regimen using Her Option Cryotherapy|Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.
12062676|NCT00094523|Drug|Fosamprenavir|Fosamprenavir
12062677|NCT00094497|Drug|Etoposide|
12062678|NCT00094497|Drug|Doxorubicin|
12062679|NCT00094497|Drug|Cisplatin|
12062680|NCT00094497|Drug|Streptozotocin|
12062681|NCT00094497|Drug|Mitotane|
12062682|NCT00094484|Drug|Cinacalcet HCl|
12062683|NCT00094458|Biological|infliximab infusion; AZA placebo caps|Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
12062684|NCT00094458|Other|infliximab (IFX) infusion; azathioprine (AZA) caps|AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22
12062685|NCT00094458|Drug|infliximab (IFX) placebo infusion; azathioprine (AZA) caps|AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
12062686|NCT00094445|Drug|Curcumin|Starting dose 8 gm orally per day for 8 weeks. If patient experiences grade III toxicity, dose held and restarted with a 50% dose reduction after resolution of toxicity to </= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with </= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes.
12062687|NCT00094432|Drug|Aripiprazole|Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
12062688|NCT00094432|Drug|Placebo|Tablets, Oral, 0 mg, Once daily, 8 weeks.
12062689|NCT00094406|Procedure|Bronchoscopy|
12062690|NCT00094406|Procedure|Bronchoalveolar lavage|
12062691|NCT00094406|Drug|Endotoxin|
12062692|NCT00094406|Drug|Carbon Monoxide|
12062693|NCT00094380|Drug|CTLA4-IgG4m (RG2077)|
12062694|NCT00094380|Drug|Cyclophosphamide|
12062695|NCT00094367|Drug|Abacavir/Lamivudine|
12062696|NCT00094341|Drug|Etanercept|
12062697|NCT00094328|Drug|Bicalutamide|oral
12062698|NCT00094328|Drug|Anastrozole|oral
12062699|NCT00094315|Drug|Cocaine (IV)|
12062700|NCT00094302|Drug|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
12062701|NCT00094302|Drug|Placebo|Placebo of spironolactone
12062702|NCT00094289|Drug|Disulfiram|
12062703|NCT00094276|Behavioral|Facilitated Asthma Communication Intervention (FACI)|A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
12062704|NCT00094276|Behavioral|Breathmobile intervention|A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.
12062705|NCT00094250|Behavioral|Resistance and Aerobic Training|
12062706|NCT00094172|Drug|Atorvastatin|atorvastatin at the dose of 80 mg/day. Participants will be allowed to decrease the daily dose to 40 mg/day if the higher dose is not well-tolerated
12062707|NCT00094172|Drug|Placebo|tablet form
12062708|NCT00094159|Drug|SNS-595|
12062709|NCT00094146|Drug|Sandostatin LAR Depot|
12062710|NCT00094133|Procedure|hot flashes attenuation|
12062711|NCT00094133|Procedure|hypnotherapy|
12062712|NCT00094120|Drug|MSI-1256F (Squalamine Lactate)|
12062713|NCT00094107|Drug|Axitinib [AG-013736]|VEGFR [vascular endothelial growth factor Receptor] and PDGFR [Platelet-Derived Growth Factor Receptor] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.
12062714|NCT00094094|Drug|axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.
12062715|NCT00094081|Drug|tirapazamine (SR259075)|
12062716|NCT00094081|Drug|cisplatin|
12062717|NCT00094081|Procedure|Radiation Therapy|
12062718|NCT00091468|Drug|Transdermal nicotine patch|double-blind phase: 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks open label phase: 5mg for 1 week, 10mg. for 2 weeks, 15mg. for 23 weeks taper down: 10mg. for 2 weeks, 5mg. for 1 week
12062719|NCT00091468|Drug|Placebo transdermal patch|placebo patch, 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks
12062720|NCT00081627|Drug|CoFactor and 5FU|
12062721|NCT00094055|Drug|AG013736|AG013736, tablets 5 mg BID daily until tumor progression or toxicity
12062722|NCT00094042|Drug|Iron Supplement, 120mg|
12062723|NCT00094029|Drug|Sutent|Sutent, 25, 37.5, or 50 mg daily
12062724|NCT00094016|Drug|beclomethasone dipropionate|
12062725|NCT00094003|Drug|NS-9 [Poly I: Poly C]|
12062726|NCT00093990|Drug|Tipifarnib;Zarnestra; R115777|
12062727|NCT00093977|Drug|darbepoetin alfa SF|"Frequency of dosing depends on frequency at randomization:
~rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL"
12062793|NCT00093600|Drug|daunorubicin hydrochloride|
12062794|NCT00093600|Drug|midostaurin|
12062795|NCT00093587|Biological|anti-thymocyte globulin|
12062796|NCT00093587|Drug|busulfan|
12062728|NCT00093964|Drug|Cilengitide 500 mg|Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
12062729|NCT00093964|Drug|Cilengitide 2000 mg|Subjects will receive 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
12062730|NCT00093951|Drug|SGS742|
12062731|NCT00093938|Drug|Cranberry juice|
12062732|NCT00093925|Drug|clevidipine|
12062733|NCT00093925|Drug|nicardipine|
12062734|NCT00093912|Drug|clevidipine|
12062735|NCT00093912|Drug|sodium nitroprusside|
12062736|NCT00093899|Drug|ezetimibe (+) simvastatin|Duration of Treatment: 6 months
12062737|NCT00093886|Drug|clevidipine|
12062738|NCT00093886|Drug|nitroglycerin|
12062739|NCT00093873|Drug|Anti-angiogenesis|Anti-angiogenesis
12062740|NCT00093873|Drug|AMG 706|Anti-angiogenesis
12062741|NCT00093847|Drug|S-adenosyl methione (SAMe)|Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
12062742|NCT00093847|Drug|Placebo|Placebo to be taken daily for 6 weeks
12062743|NCT00093834|Biological|allogeneic GM-CSF-secreting breast cancer vaccine|The first three patients will receive a dose of 5 X 107 cells, and the next three will receive a dose of 5 X 108 cells. Then, if these two doses of vaccine alone are found to be safe, a fixed vaccine dose of 5 X 108 cells will be tested in combination with chemotherapy based on the safety of the allogeneic breast vaccine alone and the safety and bioactivity of a dose of 5 X 108 cells in the allogeneic pancreatic vaccine trial
12062744|NCT00093834|Drug|cyclophosphamide|This trial will be a dose ranging study of a fixed sequence of drug doses in a three by three factorial matrix modeled after the theories of Plackett and Burman (Plackett et al., 1946), and is designed to determine the doses of CY and DOX that maximize the immunologic response to vaccination
12062745|NCT00093834|Drug|doxorubicin hydrochloride|This trial will be a dose ranging study of a fixed sequence of drug doses in a three by three factorial matrix modeled after the theories of Plackett and Burman (Plackett et al., 1946), and is designed to determine the doses of CY and DOX that maximize the immunologic response to vaccination
12062746|NCT00093821|Drug|tanespimycin|Given IV
12062747|NCT00093821|Other|pharmacological study|Correlative studies
12062748|NCT00093821|Other|laboratory biomarker analysis|Correlative studies
12062749|NCT00093808|Biological|trastuzumab|
12062750|NCT00093808|Drug|capecitabine|
12062751|NCT00093808|Drug|vinorelbine tartrate|
12062752|NCT00093795|Drug|Cyclophosphamide|"Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles"
12062753|NCT00093795|Drug|Docetaxel|75 mg/m2 IV every 21 days for 6 cycles
12062754|NCT00093795|Drug|Gemcitabine|2000 mg/m2 IV every 14 days for 4 cycles
12062755|NCT00093795|Drug|Paclitaxel|175 mg/m2 IV every 14 days for 4 cycles
12062756|NCT00093795|Drug|Doxorubicin|"Group 1: 50 mg/m2 IV every 21 days for 6 cycles
~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
12062757|NCT00093782|Drug|temsirolimus|Given IV
12062758|NCT00093782|Other|laboratory biomarker analysis|Correlative studies
12062759|NCT00093769|Drug|bortezomib + rituximab|"Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
~Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
~Patients in either arm may crossover to the other arm if treatment is found to be ineffective."
12062760|NCT00093756|Radiation|3-dimensional conformal radiation therapy|
12062761|NCT00093756|Drug|bortezomib|Given IV
12062762|NCT00093756|Drug|paclitaxel|Given IV
12062763|NCT00093756|Drug|carboplatin|Given IV
12062764|NCT00093743|Drug|fludarabine phosphate|Given IV
12062765|NCT00093743|Drug|cyclosporine|Given IV or PO
12062766|NCT00093743|Radiation|total-body irradiation|Undergo TBI
12062767|NCT00093743|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow transplantation
12062768|NCT00093743|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC transplantation
12062769|NCT00093743|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplantation
12062770|NCT00093743|Drug|mycophenolate mofetil|Given PO or IV
12062771|NCT00093730|Drug|BMS-59926|
12062772|NCT00093704|Drug|bortezomib + ganciclovir|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.
12062773|NCT00093678|Drug|celecoxib|
12062774|NCT00093678|Procedure|anticachectic therapy|
12062775|NCT00093678|Procedure|nutritional support|
12062776|NCT00093678|Procedure|pain therapy|
12062777|NCT00093678|Procedure|supportive care/therapy|
12062778|NCT00093665|Drug|cisplatin|
12062779|NCT00093665|Drug|fluorouracil|
12062780|NCT00093665|Radiation|radiation therapy|
12062781|NCT00093652|Drug|gefitinib|
12062782|NCT00093652|Drug|oxaliplatin|
12062783|NCT00093652|Procedure|conventional surgery|
12062784|NCT00093652|Procedure|neoadjuvant therapy|
12062785|NCT00093652|Radiation|radiation therapy|
12062786|NCT00093639|Drug|everolimus|
12062787|NCT00093639|Drug|imatinib mesylate|
12062788|NCT00093626|Other|Laboratory Biomarker Analysis|Correlative studies
12062789|NCT00093626|Drug|Sorafenib Tosylate|Given orally
12062790|NCT00093613|Drug|sorafenib tosylate|Given PO
12062791|NCT00093613|Other|pharmacological study|Correlative studies
12062792|NCT00093600|Drug|cytarabine|
12062799|NCT00093587|Procedure|allogeneic bone marrow transplantation|
12062800|NCT00093587|Procedure|peripheral blood stem cell transplantation|
12062801|NCT00093587|Radiation|radiation therapy|
12062802|NCT00093561|Dietary Supplement|lycopene|
12062803|NCT00093548|Biological|alpha fetoprotein adenoviral vector vaccine|
12062804|NCT00093548|Biological|alpha fetoprotein plasmid DNA vaccine|
12062805|NCT00093548|Biological|sargramostim plasmid DNA hepatocellular carcinoma vaccine adjuvant|
12062806|NCT00093522|Biological|autologous tumor cell vaccine|
12062807|NCT00093522|Biological|keyhole limpet hemocyanin|
12062808|NCT00093522|Biological|therapeutic autologous dendritic cells|
12062809|NCT00093522|Drug|fludarabine phosphate|
12062810|NCT00093522|Procedure|conventional surgery|
12062811|NCT00093509|Drug|doxorubicin hydrochloride|To be dosed at 75 mg/m2 i.v. push every 4 weeks for 4 cycles. This treatment is optional and will not be used on all subjects.
12062812|NCT00093509|Drug|ifosfamide and mesna|2 gm / m2 ifosfamide mixed in 1000 cc D5W infused continuously over 24 hours daily for 6 days (144 hours); total ifosfamide dose 12 gm/ m2. For the day infusion only MESNA (sodium 2-mercapto-ethanesulphonate) is mixed with ifosfamide as above and given at 2.5 gm / m2 / 24 hours.
12062813|NCT00093509|Procedure|hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator|Patients will receive hyperthermia throughout the course of radiotherapy delivered once weekly for a total of 5 treatments. Each treatment will last 1-2 hours with a goal of delivering a cumulative thermal dose of 10-100 CEM 43˚T90.
12062814|NCT00093509|Radiation|radiation therapy|External beam megavoltage (≥ 4 MV) beams will be used at SSD, SAD ≥ 70 cm at a dose rate of > 100 cGy/min. Fraction sizes of 180 cGy will be used 5 times per weeks in a continuous course. Total dose will be 45 Gy + 10%, consistent with sites being treated.
12062815|NCT00093496|Drug|gemcitabine hydrochloride|Given IV
12062816|NCT00093496|Drug|tanespimycin|Given IV
12062817|NCT00093483|Biological|filgrastim|Subcutaneously beginning 12 hours after the last dose of chemotherapy and continuing until blood counts recover.
12062818|NCT00093483|Drug|arsenic trioxide|IV over 1 hour on day 1
12062819|NCT00093483|Drug|cytarabine|IV over 1 hour every 12 hours on days 1-6
12062820|NCT00093483|Drug|idarubicin|IV over 30 minutes on days 2-4 (immediately after doses 3, 5 and 7 of cytarabine).
12062821|NCT00093470|Procedure|Clinical Observation|Undergo observation
12062822|NCT00093470|Drug|Tipifarnib|Given PO
12062823|NCT00093457|Drug|sorafenib tosylate|BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
12062824|NCT00093444|Drug|lyso-thermosensitive liposomal doxorubicin|
12062825|NCT00093444|Procedure|radiofrequency ablation|
12062826|NCT00093418|Drug|tipifarnib|Given orally
12062827|NCT00093405|Drug|tanespimycin|
12062828|NCT00093379|Drug|Capecitabine|825 mg/m^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.
12062829|NCT00093379|Drug|Oxaliplatin|50 mg/m^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.
12062830|NCT00093379|Radiation|Radiation Therapy (XRT)|Undergo radiotherapy* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. *Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.
12062831|NCT00093366|Biological|etanercept|
12062832|NCT00093366|Drug|arsenic trioxide|
12062833|NCT00093353|Drug|cefixime|
12062834|NCT00093353|Drug|irinotecan hydrochloride|
12062835|NCT00093353|Drug|temozolomide|
12062836|NCT00093327|Procedure|Acupuncture|
12062837|NCT00093314|Drug|HuMax-CD20|
12062838|NCT00093860|Drug|Propranolol|
12062839|NCT00093301|Drug|Levosimendan|
12062840|NCT00093301|Drug|Dobutamine|
12062841|NCT00093288|Drug|bupropion XL|
12062842|NCT00093275|Drug|HP184|
12062843|NCT00093262|Drug|clevidipine|
12062844|NCT00093262|Drug|placebo|
12062845|NCT00093249|Drug|clevidipine|Clevidipine (0.5 mg/mL in 20% lipid emulsion)will be administered intravenously at an initial infusion rate of 0.4 µg/kg/min and will be titrated, as tolerated, at the discretion of the investigator, in doubling increments approximately every 90 seconds up to a maximum of 3.2 µg/kg/min, in order to achieve the desired blood pressure lowering effect. Clevidipine may be titrated upwards or downwards and may be temporarily interrupted and restarted to attain the desired blood pressure effect. The maximum study drug infusion rate of 8.0 µg/kg/min may not be exceeded.
12062846|NCT00093249|Drug|placebo|Placebo (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.
12062847|NCT00093236|Procedure|Early Periodontal Treatment|Subjects will receive scaling and root planing at baseline. Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health.comprehensive periodontal treatment
12062848|NCT00093236|Procedure|Usual Dental Hygiene|Subjects will receive routine oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation.
12062849|NCT00093223|Drug|Paclitaxel Nanoparticle Albumin Bound|Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s).
12062850|NCT00093223|Drug|Paclitaxel Nanoparticle Albumin Bound|
12062851|NCT00093223|Drug|Paclitaxel Nanoparticle Albumin Bound|35mg/35 infusion time is 3.5 minutes
12062852|NCT00093210|Drug|rFIX|
12062853|NCT00093210|Drug|rFIX-R|
12062854|NCT00093197|Drug|KAI-9803 for Injection|0.05 mg
12062855|NCT00093197|Drug|KAI-9803 for Injection|0.5 mg
12062856|NCT00093197|Drug|KAI-9803 for Injection|1.25 mg
12062857|NCT00093197|Drug|KAI-9803 for Injection|5 mg
12062858|NCT00093197|Drug|Placebo|
12062859|NCT00093184|Drug|Angiomax (bivalirudin) anticoagulant|
12062860|NCT00093171|Drug|rFIX|
12062861|NCT00093158|Drug|Angiomax (bivalirudin) anticoagulant|
12062862|NCT00093145|Drug|Albumin-bound paclitaxel|Administered by intravenous infusion.
12062863|NCT00093145|Drug|Carboplatin|Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.
12062864|NCT00093145|Drug|Herceptin®|Administered by IV infusion
12062865|NCT00002543|Drug|gallium nitrate|
12062866|NCT00002524|Biological|Bleomycin Sulfate|
12062867|NCT00002524|Biological|Filgrastim|
12062868|NCT00002524|Drug|Cisplatin|
12062869|NCT00002524|Drug|Cyclophosphamide|
12062870|NCT00002524|Drug|Cytarabine|
12062871|NCT00002524|Drug|Doxorubicin Hydrochloride (DOX)|
12062872|NCT00002524|Drug|Etoposide|
12062873|NCT00002524|Drug|Fluorouracil|
12062874|NCT00002524|Drug|Ifosfamide|
12062875|NCT00002524|Drug|Leucovorin calcium|
12062876|NCT00002524|Drug|Methotrexate|
12062877|NCT00002524|Drug|Methylprednisolone|
12062878|NCT00002524|Drug|Pentamidine|
12062879|NCT00002524|Drug|Prednisone|
12062880|NCT00002524|Drug|Trimethoprim-Sulfamethoxazole|
12062881|NCT00002524|Drug|Vincristine Sulfate|
12062882|NCT00002524|Drug|Zidovudine (AZT)|
12062883|NCT00002524|Radiation|Radiation Therapy|
12062884|NCT00093132|Drug|Satraplatin|Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
12062885|NCT00093119|Drug|ABI-007|
12062886|NCT00093093|Drug|Viramidine|
12062887|NCT00093093|Drug|Ribavirin|
12062888|NCT00093093|Drug|pegylated interferon alfa-2a|
12062889|NCT00093080|Drug|ridaforolimus|12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
12062890|NCT00093067|Drug|daptomycin|
12062891|NCT00093054|Drug|Cranberry juice|TID dosage for UTI treatment
12062892|NCT00093054|Dietary Supplement|Placebo cranberry juice|TID placebo dosage to match active comparator
12062893|NCT00093041|Drug|Zalutumumab|Weekly infusion
12062894|NCT00093028|Drug|CC-5013 (Revlimid™)|N/A Study Complete
12062895|NCT00093028|Drug|bortezomib|N/A Study Complete
12062896|NCT00091520|Drug|Nesiritide|
12062897|NCT00093015|Drug|Placebo|Volume and dose frequency changes resembling dosing in the active treatment group
12062898|NCT00093015|Drug|darbepoetin alfa|Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL
12062899|NCT00093002|Drug|Fulvestrant|250 mg & 500 mg intramuscular injection
12062900|NCT00092989|Drug|montelukast sodium|Duration of Treatment: 1 dose
12062901|NCT00092989|Drug|placebo|Duration of Treatment: 1 dose
12062902|NCT00092976|Drug|ReFacto|
12062903|NCT00092963|Drug|MK0462, rizatriptan benzoate / Duration of Treatment: 1day|
12062904|NCT00092963|Drug|Comparator: placebo / Duration of Treatment: 1 day|
12062905|NCT00092924|Drug|TRAIL-R1 mAb (TRM-1;HGS-ETR1)|
12062906|NCT00092911|Drug|DVS-233 SR|
12062907|NCT00092898|Drug|MK0653, ezetimibe|
12062908|NCT00092898|Drug|Comparator: placebo|
12062909|NCT00092885|Drug|MK0476, montelukast sodium|
12062910|NCT00092885|Drug|Comparator: placebo|
12062911|NCT00092872|Drug|MK0557|
12062912|NCT00092859|Drug|MK0557|
12062913|NCT00092846|Drug|MK0803, lovastatin|
12062914|NCT00092846|Behavioral|Self-Management System|
12062915|NCT00092833|Drug|Comparator: ezetimibe|Ezetimibe (MK0653) 10 mg once daily for 3 years.
12062916|NCT00092820|Drug|MK0653, ezetimibe|
12062917|NCT00092820|Drug|Comparator: placebo|
12062918|NCT00092807|Drug|MK0653, ezetimibe|
12062919|NCT00092807|Drug|Comparator: placebo|
12062920|NCT00092781|Drug|MK0663, etoricoxib|
12062921|NCT00092781|Drug|Comparator: celecoxib|
12062922|NCT00092768|Drug|MK0663, etoricoxib|
12062923|NCT00092768|Drug|Comparator: celecoxib|
12062924|NCT00092755|Drug|MK0663, etoricoxib|
12062925|NCT00092755|Drug|Comparators: ibuprofen and placebo|
12062926|NCT00092742|Drug|MK0663, etoricoxib|
12062927|NCT00092742|Drug|Comparator: Diclofenac sodium|
12062928|NCT00092729|Drug|etoricoxib (MK0663)|Two etoricoxib 60 mg tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
12062929|NCT00092729|Drug|Comparator: placebo (unspecified)|Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
12062930|NCT00092729|Drug|Comparator: naproxen sodium|Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
12062931|NCT00092716|Drug|MK0653, ezetimibe / Duration of Treatment: 28 weeks|
12062932|NCT00092716|Drug|Comparator: atorvastatin / Duration of Treatment: 28 weeks|
12062933|NCT00092703|Drug|MK0663, etoricoxib|
12062934|NCT00092703|Drug|Comparator: Diclofenac sodium|
12062935|NCT00092690|Drug|MK0653A, ezetimibe (+) simvastatin|
12062936|NCT00092690|Drug|Comparator: atorvastatin|
12062937|NCT00092677|Drug|ezetimibe (+) simvastatin|Duration of Treatment: 4 years
12062938|NCT00092677|Drug|Comparator: Placebo|matching Placebo
12062939|NCT00092664|Drug|MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks|
12062940|NCT00092651|Drug|MK0653A, ezetimibe (+) simvastatin|
12062941|NCT00092651|Drug|Comparators: simvastatin and ezetimibe|
12062942|NCT00092586|Drug|MK0653, ezetimibe|
12062943|NCT00092586|Drug|Comparator: statins|
12062944|NCT00092573|Drug|MK0653, ezetimibe|
12062945|NCT00092573|Drug|Comparator: fenofibrate monotherapy|
12062946|NCT00092560|Drug|MK0653, ezetimibe|
12062947|NCT00092560|Drug|Comparator: fenofibrate monotherapy|
12062948|NCT00092547|Biological|V501|0.5 mL intramuscular injection of V501
12062949|NCT00092547|Biological|Comparator: Placebo|0.5 mL intramuscular injection of placebo
12062950|NCT00092534|Biological|Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine|A 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.
12062951|NCT00092534|Biological|Matching Placebo|A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.
12062952|NCT00092521|Biological|V501|Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
12062953|NCT00092521|Biological|Comparator: Placebo|a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
12062954|NCT00092521|Biological|Human Papillomavirus (HPV) 16 Monovalent|HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
12062955|NCT00092508|Drug|OPC-6535|
12062956|NCT00092508|Drug|Asacol®|
12062957|NCT00092300|Drug|MK0966, rofecoxib|
12062958|NCT00092300|Drug|Comparator: valdecoxib|
12062959|NCT00092950|Behavioral|Physical activity|
12062960|NCT00092937|Drug|Busulfan|
12062961|NCT00092638|Drug|MK0653, ezetimibe|
12062962|NCT00092638|Drug|Comparator: ezetimibe, placebo|
12062963|NCT00092625|Drug|MK0653, ezetimibe|
12062964|NCT00092625|Drug|Comparator: ezetimibe, placebo|
12062965|NCT00092612|Drug|MK0653, ezetimibe|
12062966|NCT00092612|Drug|Comparator: ezetimibe, placebo|
12062967|NCT00092599|Drug|MK0653, ezetimibe|
12062968|NCT00092599|Drug|Comparator: ezetimibe, placebo|
12062969|NCT00092495|Biological|V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine|qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
12062970|NCT00092482|Biological|V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years|
12062971|NCT00092469|Biological|V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine|
12062972|NCT00092456|Biological|rotavirus vaccine, live, oral, pentavalent|Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
12062973|NCT00092456|Biological|Placebo|"Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10
~weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination"
12062974|NCT00092443|Biological|RotaTeq™, rotavirus vaccine, live, oral, pentavalent|Three doses of RotaTeq™ administered 28 to 70 days apart.
12062975|NCT00092443|Biological|Comparator: Placebo matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart.
12062976|NCT00092430|Biological|V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks|
12062977|NCT00092417|Biological|Comparator: Varicella Zoster Virus Vaccine|Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose)
12062978|NCT00092417|Biological|Comparator: Varicella Zoster Virus Vaccine|Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL dose)
12062979|NCT00092404|Biological|measles, mumps, and rubella virus vaccine live|
12062980|NCT00092404|Biological|Comparator: Measles, Mumps, and Rubella Virus Vaccine Live|
12062981|NCT00092391|Biological|Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live|0.5 mL subcutaneous injection of one of three sub-lots on Day 0
12062982|NCT00092391|Biological|Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)|0.5 mL subcutaneous injection on Day 0
12062983|NCT00092378|Drug|MK0966, rofecoxib|
12062984|NCT00092378|Drug|Comparator: diclofenac sodium, placebo|
12062985|NCT00092365|Drug|MK0966, rofecoxib|
12062986|NCT00092365|Drug|Comparator: celecoxib, placebo|
12062987|NCT00092352|Drug|MK0966, rofecoxib|
12062988|NCT00092352|Drug|Comparator: celecoxib, placebo|
12062989|NCT00092339|Drug|MK0966, rofecoxib|
12062990|NCT00092339|Drug|Comparator: valdecoxib, placebo|
12062991|NCT00092326|Drug|MK0966, rofecoxib|
12062992|NCT00092326|Drug|Comparator: oxycodone with acetaminophen, placebo|
12062993|NCT00092313|Drug|MK0966, rofecoxib|
12062994|NCT00092313|Drug|Comparator: oxycodone and acetaminophen|
12062995|NCT00092287|Drug|lanreotide Autogel (somatostatin analogue)|
12062996|NCT00092287|Drug|Sandostatin long acting release (LAR) Depot (somatostatin analogue)|
12062997|NCT00092274|Drug|HuMax-CD20|
12062998|NCT00092001|Drug|Sunitinib|Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
12062999|NCT00091650|Drug|Olanzapine|
12063000|NCT00091650|Drug|placebo|
12063001|NCT00092209|Drug|MK0954A, hydrochlorothiazide (+) losartan potassium|
12063002|NCT00092209|Drug|Comparator: placebo, losartan, hydrochlorothiazide|
12063003|NCT00092196|Drug|MK0869, aprepitant / Duration of Treatment: 3 days|
12063004|NCT00092183|Drug|MK0869, aprepitant / Duration of Treatment: 3 days|
12063005|NCT00092183|Drug|Comparator: ondansetron / Duration of Treatment: 3 days|
12063006|NCT00092170|Drug|MK0826, ertapenem sodium|
12063007|NCT00092170|Drug|Comparator: Ticarcillin/Clavulanate|
12063008|NCT00092157|Drug|MK0733, simvastatin|
12063009|NCT00092157|Drug|Comparator: simvastatin|
12063010|NCT00092144|Drug|MK0476, montelukast sodium / Duration of Treatment: 4 weeks|
12063011|NCT00092144|Drug|Comparator: placebo / Duration of Treatment: 4 weeks|
12063012|NCT00092131|Drug|Comparator: Montelukast|Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
12063013|NCT00092131|Drug|Comparator: Placebo|Placebo tablet administered orally as a single witnessed dose before exercise challenge
12063014|NCT00092118|Drug|Montelukast|one 10 mg tablet, taken once daily at bed time for 6 weeks
12063015|NCT00092118|Drug|Comparator: Placebo|one placebo tablet, taken once daily at bed time for 6 weeks
12063016|NCT00092105|Drug|MK0476, montelukast sodium|
12063017|NCT00092105|Drug|Comparator: placebo|
12063018|NCT00092092|Drug|Montelukast chewable tablets|Montelukast sodium 5 mg chewable tablets
12063019|NCT00092092|Drug|Budesonide inhaler|Budesonide 200 mcg inhalation powder
12063020|NCT00092092|Drug|Placebo to montelukast chewable tablets|Placebo chewable tablets
12063021|NCT00092092|Drug|Placebo to budesonide inhaler|Placebo inhalation powder
12063022|NCT00092079|Drug|MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks|
12063023|NCT00092066|Drug|MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks|
12063024|NCT00092053|Drug|Placebo|tablets
12063025|NCT00092053|Drug|ibandronate|50 mg tablets
12063026|NCT00092040|Drug|MK0217, alendronate sodium/Duration of Intervention: 12 mo|
12063027|NCT00092040|Drug|Comparator: risedronate / Duration of Intervention: 12 mo|
12063028|NCT00092027|Drug|MK0217, alendronate sodium/Duration of Treatment: 6 months|
12063029|NCT00092027|Drug|Comparator: placebo / Duration of Treatment: 6 months|
12063030|NCT00092014|Drug|Alendronate|Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
12063031|NCT00092014|Drug|Risedronate 35 mg|Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
12063032|NCT00092014|Dietary Supplement|Elemental Calcium|Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
12063033|NCT00092014|Dietary Supplement|Vitamin D|Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
12063034|NCT00092014|Drug|Risendronate placebo|Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
12063035|NCT00092014|Drug|Alendronate placebo|Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
12063036|NCT00091962|Behavioral|Psychoeducation; Treatment recommendations|Counseling program
12063037|NCT00091962|Drug|Pharmacotherapy|Recommendations to patients' PCP for medication to treat depression
12063038|NCT00091962|Other|Usual Care|Physicians' Usual care
12063039|NCT00092222|Drug|Etoposide|Etoposide 50 mg/m2 /day continuous intravenous infusion (CIVI) over 24 hours x 4 days (days 1-4) of 21 day cycle. A maximum of 6 cycles of R-EPOCH-R will be administered except in exceptional circumstances.
12063040|NCT00092222|Drug|Interferon-alpha|Ages 18 and over: Initial dose of 7.5 million units subcutaneous, three times weekly x 14 days; subsequent dosesincrease dose as tolerated each 14 days to a maximum of 45 million units subcutaneous three times weekly; Ages 12-17: Initial dose of 5 million units/m2 subcutaneous, three times weekly x 14 days Subsequent doses: Increase dose as tolerated each 14 days to a maximum of 30 million units/m2 subcutaneous, three times weekly
12063041|NCT00092222|Drug|Rituximab|Rituximab 375 mg/m2 IV day 1, shall be administered prior to Doxil injection. When combined with EPOCH chemotherapy, Rituximab will be given on days 1 and 5.
12063042|NCT00092222|Drug|Zidovudine|Cycle 1: Zidovudine 600 mg PO QID x 7-21 days in outpatient setting;600 mg PO q6hours x 7-21 (Intravenous zidovudine 300 mg q 6 hours may be substituted) days for inpatients; Cycle 2 and beyond: 600 mg PO QID x 7 days in outpatient setting; 600 mg PO q 6 hours x 7 days (300 mg q 6 hours may be substituted)
12063043|NCT00092222|Drug|Liposomal Doxorubicin|21 day cycle; 20 mg/m2 Liposomal Doxorubicin given on day 1 and shall be administered after completion of Rituximab infusion from 2 to 6 cycles.
12063044|NCT00092222|Drug|Bortezomib|1.3 mg/m2 IV days 1, 4, 8, and 11. Cycle length is 21 days.
12063045|NCT00092222|Drug|Valganciclovir|Cycle 1: Valganciclovir 900 mg PO BID x 7-21 days in outpatient setting; 900 mg PO q 12 hours x 7-21 days for inpatients; Cycle 2 and beyond: 900 mg PO BID x 7 days for outpatients; 900 mg PO q 12 hours x 7 days (Intravenous ganciclovir 5 mg/kg may be substituted) for inpatients
12063046|NCT00092222|Drug|Doxorubicin|10 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.
12063047|NCT00092222|Drug|Vincristine|0.4 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.
12063048|NCT00092222|Drug|Cyclophosphamide|Cyclophosphamide: if CD4 < 100 cells/mm3, 187 mg/m2 IV (Day 5) if CD4 greater than or equal to 100 cells/mm3, 375 mg/m2 IV (Day 5) of 21 day cycle.
12063049|NCT00092222|Drug|Filgrastim (G-CSF)|Filgrastim 300 micrograms subcutaneous daily beginning day 6 until absolute neutrophil count recovery 5000 cells/mm3 (Pegfilgrastim may be substituted with PI approval, at the recommended dose of one 6mg syringe)
12063050|NCT00092222|Drug|Prednisone|Prednisone 60 mg/m2/day PO x 5 days (days 1-5)of 21 day cycle.
12063051|NCT00092222|Drug|Sirolimus|Maximum daily dose of 40 mg given as a single agent on 21 day cycle.
12063052|NCT00092222|Other|Observation Only|Observation of symptoms
12063053|NCT00091988|Behavioral|Lifestyle & Behavioral Change Program|Participants in the weight loss arm will receive an intensive group-based behavioral weight loss program. In the first six months of the intervention, all participants in the weight loss arm will be given skill-based diet and exercise prescriptions for weight loss and will be taught specific cognitive and behavioral skills to assist in the modification of their eating and exercise habits. Participants will meet weekly for 6 months in group sessions led by a nutritionist, exercise physiologist, or behaviorist and will follow a structured protocol. This intervention strategy is modeled on interventions that have been successful in other overweight populations and is similar to the programs implemented in our ongoing studies, such as Look AHEAD. With this intervention, women are expected to lose on average of 7-9% of their initial body weight.
12063054|NCT00091988|Behavioral|Structured Education Program|Women randomized to the Structured Education Program will be invited to participate in hour long group educational sessions at months 1, 2, 3, and 4. At months 6, 9 and 15, the groups will meet again for group support sessions. The content of these education and support sessions will include information about weight loss, physical activity, healthy eating habits and general health promotion. The educational sessions will be delivered primarily in a group format, with individual make up sessions provided for participants who miss group sessions.
12063055|NCT00091975|Drug|Zemplar Capsule|
12063056|NCT00091949|Drug|pioglitazone|a thiazolidinedione drug
12063057|NCT00091949|Drug|placebo|an inactive substance
12063058|NCT00091923|Device|Eye patch|
12063059|NCT00091923|Device|Spectacles|
12063060|NCT00091936|Drug|Didanosine|
12063061|NCT00091936|Drug|Efavirenz|
12063062|NCT00091936|Drug|Lamivudine|
12063063|NCT00091936|Drug|Standard TB treatment|
12063064|NCT00091910|Drug|Epoetin alfa|
12063065|NCT00091858|Drug|Darbepoetin Alfa|6.75 mcg/kg Q4W
12063066|NCT00091858|Drug|Placebo|Placebo Q4W
12063067|NCT00091845|Drug|AVI-4020 Injection|
12063068|NCT00091832|Biological|Denosumab|Denosumab administered by subcutaneous injection
12063069|NCT00091832|Drug|IV Bisphosphonates|Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid
12063070|NCT00091819|Drug|Telavancin|Telavancin 10 mg/kg/day, IV for up to 14 days.
12063071|NCT00091819|Drug|Vancomycin|Vancomycin 1 Gm IV q 12 hrs for up to 14 days.
12063072|NCT00091806|Drug|panitumumab (ABX-EGF)|6 mg/kg once every 2 weeks
12063073|NCT00091806|Drug|Panitumumab|9 mg/kg once every 3 weeks
12063074|NCT00091793|Drug|AMG 162|60 mg/mL denosumab given day 1, month 6, month 12 and month 18
12063075|NCT00091793|Drug|Placebo|Placebo given at day 1, month 6, month 12 and month 18
12063076|NCT00091897|Drug|Rituximab|
12063077|NCT00091897|Drug|rituximab or placebo|A fixed dose of Rituximab or placebo 1GM on Day 1 and 1GM on day 15 (+/- 2 days)
12063078|NCT00091741|Drug|Etanercept (Enbrel)|
12063079|NCT00091728|Drug|Depo Medroxyprogesterone acetate|
12063080|NCT00091728|Drug|Combined oral contraceptives|
12063081|NCT00091715|Drug|bosentan|65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
12063082|NCT00091715|Drug|placebo|placebo for 6 months followed by an open-label period
12063083|NCT00091702|Biological|Cold-adapted live attenuated influenza vaccine (FluMist)|
12063084|NCT00091702|Biological|Inactivated influenza vaccine (IAIV)|
12063085|NCT00091689|Drug|852A|
12063086|NCT00091676|Biological|FNHLId1|5 monthly vaccinations over a 6 month time period consisting of 0.5 mg ID-KLH s.c. on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
12063087|NCT00091676|Biological|KLH + GM-CSF|5 monthly vaccinations at month 1, 2, 3, 4, and 6 consisting of 0.5 mg KLH s.c on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
12063088|NCT00091663|Drug|Tarceva (erlotinib HCl)|
12063089|NCT00091637|Drug|Pexelizumab|Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once
12063090|NCT00091637|Drug|Placebo infusion|bolus infusion over a 10 minute period once
12063091|NCT00004905|Biological|filgrastim|
12063092|NCT00004905|Biological|recombinant interferon alfa|
12063093|NCT00004905|Drug|cyclophosphamide|
12063094|NCT00004905|Drug|cytarabine|
12063095|NCT00004905|Drug|etoposide|
12063096|NCT00004905|Drug|idarubicin|
12063097|NCT00004905|Procedure|peripheral blood stem cell transplantation|
12063098|NCT00004905|Radiation|radiation therapy|
12063099|NCT00004209|Drug|cisplatin|
12063100|NCT00004209|Drug|mitomycin C|
12063101|NCT00004209|Drug|vinblastine sulfate|
12063102|NCT00004195|Drug|eniluracil|Will be given to either subject pre-operative and metastatic disease
12063103|NCT00004195|Procedure|conventional colon surgery|Only if the subject is amenable to surgical resections
12063104|NCT00004194|Drug|fludarabine phosphate|
12063105|NCT00004184|Biological|monoclonal antibody 4B5 anti-idiotype vaccine|
12063106|NCT00004184|Biological|sargramostim|
12063107|NCT00004184|Drug|alum adjuvant|
12063108|NCT00004172|Biological|filgrastim|
12063109|NCT00004172|Drug|carboplatin|
12063110|NCT00004172|Drug|cyclophosphamide|
12063111|NCT00004172|Drug|ifosfamide|
12063112|NCT00004172|Drug|thiotepa|
12063113|NCT00004172|Procedure|peripheral blood stem cell transplantation|
12063114|NCT00004172|Radiation|radiation therapy|
12063115|NCT00091624|Drug|CC-5013|
12063116|NCT00091598|Drug|Ambrisentan|
12063117|NCT00091585|Drug|SNS-595|
12063118|NCT00091572|Drug|Temozolomide|"oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days (7 days on / 7 days off continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop."
12063119|NCT00091572|Drug|Dacarbazine|intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
12063120|NCT00091559|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months|
12063121|NCT00004089|Biological|filgrastim|
12063122|NCT00004089|Drug|fluorouracil|
12063123|NCT00004089|Drug|hydroxyurea|
12063124|NCT00004089|Drug|paclitaxel|
12063125|NCT00004089|Procedure|conventional surgery|
12063126|NCT00004089|Radiation|radiation therapy|
12063127|NCT00004083|Drug|cisplatin liposomal|
12063128|NCT00004014|Drug|pegylated liposomal doxorubicin hydrochloride|Doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter.
12063129|NCT00003956|Drug|fluorouracil|
12063130|NCT00003956|Drug|leucovorin calcium|
12063131|NCT00003956|Drug|lonafarnib|
12063132|NCT00003858|Drug|mitoxantrone hydrochloride|
12063133|NCT00003842|Biological|interleukin-4 PE38KDEL cytotoxin|
12063134|NCT00003842|Drug|isolated perfusion|
12063135|NCT00003842|Procedure|surgical procedure|
12063136|NCT00003780|Biological|tumor infiltrating lymphocyte therapy|
12063137|NCT00003780|Drug|gemcitabine hydrochloride|
12063139|NCT00003714|Drug|Pyrazoloacridine|IV (by vein) over 3 hours every 3 weeks
12063140|NCT00003711|Drug|irinotecan hydrochloride|
12063141|NCT00003711|Drug|pemetrexed disodium|
12063142|NCT00091611|Drug|IL-2 (interleukin-2)|
12063143|NCT00091611|Drug|OKT3|
12063144|NCT00091611|Drug|Cyclophosphamide|
12063145|NCT00091611|Drug|Fludarabine|
12063146|NCT00091611|Drug|Mesna|
12063147|NCT00091507|Drug|GIK|Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.
12063148|NCT00091507|Drug|Placebo|Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.
12063149|NCT00091481|Drug|Zemplar|
12063150|NCT00091442|Drug|Docetaxel|Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
12063151|NCT00091442|Drug|DOXIL|DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
12063152|NCT00004057|Drug|L-778,123|
12063153|NCT00004057|Drug|paclitaxel|
12063154|NCT00004036|Biological|sargramostim|
12063155|NCT00004036|Drug|amifostine trihydrate|
12063156|NCT00004036|Drug|carboplatin|
12063157|NCT00004036|Drug|cyclophosphamide|
12063158|NCT00004022|Biological|aldesleukin|
12063159|NCT00004022|Biological|autologous tumor cell vaccine|
12063160|NCT00004022|Biological|muromonab-CD3|
12063161|NCT00004022|Biological|therapeutic autologous lymphocytes|
12063162|NCT00004022|Procedure|surgical procedure|
12063163|NCT00003673|Drug|chemotherapy|
12063164|NCT00003673|Drug|gemtuzumab ozogamicin|
12063165|NCT00003671|Drug|asparaginase|
12063166|NCT00003671|Drug|cyclophosphamide|
12063167|NCT00003671|Drug|cytarabine|
12063168|NCT00003671|Drug|daunorubicin hydrochloride|
12063169|NCT00003671|Drug|dexamethasone|
12063170|NCT00003671|Drug|leucovorin calcium|
12063171|NCT00003671|Drug|mercaptopurine|
12063172|NCT00003671|Drug|methotrexate|
12063173|NCT00003671|Drug|thioguanine|
12063174|NCT00003671|Drug|vincristine sulfate|
12063175|NCT00003666|Drug|6-hydroxymethylacylfulvene|11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle
12063176|NCT00003634|Biological|oregovomab|
12063177|NCT00003625|Drug|cyclosporine|
12063178|NCT00003625|Drug|etoposide|
12063179|NCT00003625|Drug|vincristine sulfate|
12063180|NCT00003625|Radiation|radiation therapy|
12063181|NCT00003599|Dietary Supplement|Vitamin E (AT)|Orally daily
12063182|NCT00003599|Drug|Isotretinoin|Orally daily
12063183|NCT00003591|Drug|paclitaxel|
12063184|NCT00003591|Radiation|radiation therapy|
12063185|NCT00003587|Drug|carboplatin|AUC=5.5 day 1 every 21 days X 3
12063186|NCT00003587|Drug|cisplatin|IV cisplatin 100 mg/m^2 day 1 every 21 days X 3
12063187|NCT00003587|Drug|docetaxel|IV docetaxel 75 mg/m^2 day 1 every 21 days X 3
12063188|NCT00003587|Drug|gemcitabine|IV gemcitabine 1,000 mg/m^2/day, days 1 and 8 every 21 days X3
12063189|NCT00003587|Drug|paclitaxel|IV paclitaxel 225 mg/m^2/day, day 1 every 21 days X 3
12063190|NCT00003587|Drug|vinorelbine|IV vinorelbine 25 mg/m^2/day, days 1 and 8 every 21 days X 3
12063191|NCT00003564|Drug|Isotretinoin|Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days.
12063192|NCT00003564|Drug|Procarbazine Hydrochloride|"Arm I: Oral procarbazine once daily on days 1-14 every 28 days for 6 courses of combined therapy.
~Arm II: Oral procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses."
12063193|NCT00003551|Drug|aminocamptothecin colloidal dispersion|
12063194|NCT00003546|Drug|gemcitabine hydrochloride|given IV
12063195|NCT00003546|Radiation|radiation therapy|1.8 Gy to tumor bed
12063196|NCT00003451|Biological|recombinant interferon alfa|
12063197|NCT00003451|Biological|recombinant interleukin-12|
12063198|NCT00003441|Drug|Irofulven (MGI-114)|IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.
12063199|NCT00003430|Drug|L-778,123|
12063200|NCT00003428|Drug|arzoxifene hydrochloride|
12063201|NCT00003353|Biological|filgrastim|
12063202|NCT00003353|Drug|melphalan|
12063203|NCT00003353|Procedure|bone marrow ablation with stem cell support|
12063204|NCT00003353|Procedure|peripheral blood stem cell transplantation|
12063205|NCT00003344|Drug|irinotecan hydrochloride|
12063206|NCT00003344|Radiation|radiation therapy|
12063207|NCT00003339|Biological|gp100 antigen|
12063208|NCT00003339|Biological|incomplete Freund's adjuvant|
12063209|NCT00003339|Biological|recombinant interleukin-12|
12063210|NCT00003339|Biological|tyrosinase peptide|
12063211|NCT00003331|Drug|fluorouracil|
12063212|NCT00003331|Drug|leucovorin calcium|
12063213|NCT00003331|Drug|topotecan hydrochloride|
12063214|NCT00003288|Biological|filgrastim|
12063215|NCT00003288|Drug|cyclophosphamide|
12063216|NCT00003288|Drug|tirapazamine|
12063217|NCT00003263|Biological|recombinant interferon alfa|vaccine
12063218|NCT00003263|Drug|cisplatin|
12063219|NCT00003263|Procedure|surgical procedure|
12063220|NCT00003263|Radiation|radiation therapy|
12063221|NCT00091429|Drug|Ranolazine|
12063222|NCT00003257|Biological|Ad5CMV-p53 gene|
12063223|NCT00003252|Drug|amifostine trihydrate|
12063224|NCT00003248|Biological|rituximab|
12063225|NCT00003248|Drug|fludarabine phosphate|
12063226|NCT00003241|Drug|phenylacetate|
12063227|NCT00003223|Drug|fenretinide|200 mg/day PO, days 1-25 q 28 days x 6 cycles.
12063228|NCT00091416|Biological|VRC-HIVADV014-00-VP|
12063229|NCT00091390|Radiation|High Dose brachytherapy boost|19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.
12063230|NCT00091390|Radiation|External beam radiotherapy|45 Gy as 1.8 Gy five days a week for five weeks.
12063231|NCT00091377|Drug|cisplatin|IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
12063232|NCT00091377|Drug|paclitaxel|IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
12063233|NCT00091377|Drug|phenoxodiol|IV 3 mg/kg
12063234|NCT00091351|Procedure|conventional surgery|
12063235|NCT00091351|Radiation|radiation therapy|
12063236|NCT00091338|Biological|MART-1 antigen|
12063237|NCT00091338|Biological|gp100 antigen|
12063238|NCT00091338|Biological|incomplete Freund's adjuvant|
12063239|NCT00091338|Biological|recombinant interleukin-7|
12063240|NCT00091325|Dietary Supplement|defined green tea catechin extract|
12063241|NCT00091312|Drug|FOLFIRI regimen|
12063242|NCT00091312|Drug|fluorouracil|
12063243|NCT00091312|Drug|irinotecan hydrochloride|
12063244|NCT00091312|Drug|leucovorin calcium|
12063245|NCT00091312|Procedure|adjuvant therapy|
12063246|NCT00091299|Drug|warfarin|
12063247|NCT00091286|Biological|HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine|
12063248|NCT00091273|Biological|incomplete Freund's adjuvant|
12063249|NCT00091273|Biological|ovarian cancer peptide vaccine|
12063250|NCT00091273|Biological|sargramostim|
12063251|NCT00091273|Biological|tetanus toxoid helper peptide|
12063252|NCT00091273|Procedure|adjuvant therapy|
12063253|NCT00091260|Drug|dexamethasone|dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
12063254|NCT00091260|Drug|lenalidomide|15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
12063255|NCT00091247|Drug|tetracycline hydrochloride|
12063256|NCT00091247|Other|placebo|
12063257|NCT00091234|Drug|gemtuzumab ozogamicin|
12063258|NCT00091195|Drug|romidepsin|
12063259|NCT00091182|Drug|oxaliplatin|Given IV
12063260|NCT00091169|Dietary Supplement|levocarnitine|Given orally
12063261|NCT00091169|Other|placebo|Given orally
12063262|NCT00091156|Drug|gefitinib|
12063263|NCT00091156|Procedure|adjuvant therapy|
12063264|NCT00091143|Biological|gp100 antigen|
12063265|NCT00091143|Biological|incomplete Freund's adjuvant|
12063266|NCT00091143|Biological|keyhole limpet hemocyanin|
12063267|NCT00091143|Drug|fludarabine phosphate|
12063268|NCT00091143|Procedure|peripheral blood stem cell transplantation|
12063269|NCT00091130|Biological|HspE7|Given SC
12063270|NCT00091130|Other|placebo|Given SC
12063271|NCT00091130|Other|laboratory biomarker analysis|Correlative studies
12063272|NCT00091117|Drug|bortezomib|Given IV
12063273|NCT00091117|Other|pharmacological study|Correlative studies
12063274|NCT00091104|Biological|MART-1:27-35 peptide vaccine|
12063275|NCT00091104|Biological|aldesleukin|
12063276|NCT00091104|Biological|filgrastim|
12063277|NCT00091104|Biological|incomplete Freund's adjuvant|
12063278|NCT00091104|Biological|therapeutic autologous lymphocytes|
12063279|NCT00091104|Biological|therapeutic tumor infiltrating lymphocytes|
12063280|NCT00091104|Drug|cyclophosphamide|
12063281|NCT00091104|Drug|fludarabine phosphate|
12063282|NCT00091104|Procedure|autologous hematopoietic stem cell transplantation|
12063283|NCT00091104|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12063284|NCT00091104|Radiation|total-body irradiation|
12063285|NCT00091091|Other|medical chart review|
12063286|NCT00091091|Other|questionnaire administration|
12063287|NCT00091091|Procedure|management of therapy complications|
12063288|NCT00091078|Biological|oblimersen sodium|Given IV
12063289|NCT00091078|Drug|imatinib mesylate|Given orally
12063290|NCT00091078|Other|laboratory biomarker analysis|Correlative studies
12063291|NCT00091052|Biological|sargramostim|
12063292|NCT00091052|Radiation|radiation therapy|
12063293|NCT00091039|Biological|recombinant fowlpox GM-CSF vaccine adjuvant|
12063294|NCT00091039|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|
12063295|NCT00091039|Biological|recombinant vaccinia-CEA(6D)-TRICOM vaccine|
12063296|NCT00091039|Drug|carboplatin|
12063297|NCT00091039|Drug|paclitaxel|
12063298|NCT00091039|Radiation|radiation therapy|
12063299|NCT00091026|Biological|cetuximab|Given IV
12063300|NCT00091026|Drug|gemcitabine hydrochloride|Given IV
12063301|NCT00091026|Biological|bevacizumab|Given IV
12063302|NCT00091026|Drug|erlotinib hydrochloride|Given orally
12063303|NCT00090987|Drug|imatinib mesylate|400 mg orally once a day for up to 6 months.
12063304|NCT00090974|Procedure|quality-of-life assessment|
12063305|NCT00090961|Other|educational intervention|
12063306|NCT00090961|Other|supervised exercise program|
12063307|NCT00090909|Drug|cisplatin|
12063308|NCT00090909|Drug|dexamethasone|
12063309|NCT00090909|Drug|gemcitabine hydrochloride|
12063310|NCT00090896|Biological|maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody|
12063311|NCT00090870|Biological|PEG-interferon alfa-2b|Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
12063312|NCT00090870|Biological|GM-CSF|GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle
12063313|NCT00090870|Drug|thalidomide|200mg daily by mouth
12063314|NCT00090857|Drug|Letrozole|
12063315|NCT00090857|Other|Placebo|
12063316|NCT00090844|Drug|triptorelin|3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
12063317|NCT00090779|Drug|Emtricitabine/ tenofovir disoproxil fumarate|once daily
12063318|NCT00090779|Drug|Lopinavir/Ritonavir|twice daily
12063319|NCT00090766|Drug|valganciclovir [Valcyte]|po daily (dose based on body surface area and CrCL)
12063419|NCT00002744|Drug|daunorubicin hydrochloride|
12063320|NCT00090753|Drug|Methoxy Polyethylene Glycol-Epoetin Beta|Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
12063321|NCT00090753|Drug|Epoetin alfa|Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
12063322|NCT00090753|Drug|Epoetin beta|Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
12063323|NCT00090753|Drug|Darbepoetin alfa|Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
12063324|NCT00090727|Drug|AQ4N|
12063325|NCT00090714|Genetic|pVGI.1(VEGF2)|
12063326|NCT00090701|Drug|AG2037|
12063327|NCT00003217|Biological|filgrastim|
12063328|NCT00003217|Drug|cyclophosphamide|
12063329|NCT00003217|Drug|cytarabine|
12063330|NCT00003217|Drug|dexamethasone|
12063331|NCT00003217|Drug|doxorubicin hydrochloride|
12063332|NCT00003217|Drug|methotrexate|
12063333|NCT00003217|Drug|vincristine sulfate|
12063334|NCT00003172|Biological|filgrastim|
12063335|NCT00003172|Biological|recombinant interferon alfa|
12063336|NCT00003172|Drug|docetaxel|
12063337|NCT00003172|Drug|doxorubicin hydrochloride|
12063338|NCT00003172|Drug|fluorouracil|
12063339|NCT00003172|Drug|hydroxyurea|
12063340|NCT00003170|Dietary Supplement|glutamine|
12063341|NCT00003170|Other|placebo|
12063342|NCT00003139|Drug|pilocarpine hydrochloride|5mg pilocarpine hydrochloride tablets
12063343|NCT00003139|Other|Placebo|
12063344|NCT00003134|Drug|irinotecan hydrochloride|
12063345|NCT00003100|Dietary Supplement|soy isoflavones|
12063346|NCT00003088|Drug|cyclophosphamide|given IV
12063347|NCT00003088|Drug|doxorubicin hydrochloride|given IV
12063348|NCT00003088|Drug|paclitaxel|given IV
12063349|NCT00003072|Drug|amifostine trihydrate|
12063350|NCT00003072|Drug|carboplatin|
12063351|NCT00003072|Drug|paclitaxel|
12063352|NCT00003048|Drug|Amifostine Trihydrate|Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.
12063353|NCT00003039|Drug|alvocidib|
12063354|NCT00090688|Biological|meCS6 + LT(R192G)|
12063355|NCT00090675|Drug|ZD1839|
12063356|NCT00003005|Drug|Cordycepin|"Dose escalation study using the following doses:
~6mg/m2, 12 mg/m2, 24mg/m2, 48mg/m2"
12063357|NCT00003005|Drug|Deoxycoformycin|Dose escalation using the Fibonacci dose escalation sequence starting dose 2mg/m2, escalating to 3mg/m3 intravenous
12063358|NCT00002993|Drug|cisplatin|
12063359|NCT00002993|Drug|doxorubicin hydrochloride|
12063360|NCT00002993|Drug|mitomycin C|
12063361|NCT00002980|Drug|decitabine|
12063362|NCT00002967|Drug|cyclophosphamide|
12063363|NCT00002967|Drug|doxorubicin hydrochloride|
12063364|NCT00002967|Drug|octreotide pamoate|
12063365|NCT00002967|Drug|tamoxifen citrate|
12063366|NCT00002946|Drug|penclomedine|
12063367|NCT00002942|Procedure|autologous bone marrow transplantation|
12063368|NCT00002942|Procedure|peripheral blood stem cell transplantation|
12063369|NCT00002937|Drug|paclitaxel|
12063370|NCT00002937|Drug|valspodar|
12063371|NCT00002932|Drug|cisplatin|
12063372|NCT00002932|Radiation|radiation therapy|
12063373|NCT00002904|Drug|trabectedin|
12063374|NCT00002897|Drug|cisplatin|
12063375|NCT00002897|Drug|fluorouracil|
12063376|NCT00002897|Procedure|conventional surgery|
12063377|NCT00002873|Radiation|brachytherapy|
12063378|NCT00002872|Biological|bleomycin sulfate|
12063379|NCT00002872|Drug|doxycycline|
12063380|NCT00002872|Other|talc|
12063381|NCT00002811|Drug|liposomal T4N5 lotion|
12063382|NCT00002805|Biological|filgrastim|
12063383|NCT00002805|Drug|cladribine|
12063384|NCT00002805|Drug|cytarabine|
12063385|NCT00002805|Drug|etoposide|
12063386|NCT00002805|Drug|methotrexate|
12063387|NCT00002805|Drug|mitoxantrone hydrochloride|
12063388|NCT00002805|Drug|therapeutic hydrocortisone|
12063389|NCT00002805|Procedure|allogeneic bone marrow transplantation|
12063390|NCT00002805|Procedure|autologous bone marrow transplantation|
12063391|NCT00002805|Procedure|peripheral blood stem cell transplantation|
12063392|NCT00002805|Radiation|low-LET cobalt-60 gamma ray therapy|
12063393|NCT00002805|Radiation|low-LET electron therapy|
12063394|NCT00002805|Radiation|low-LET photon therapy|
12063395|NCT00002793|Drug|fluorouracil|
12063396|NCT00002793|Drug|leucovorin calcium|
12063397|NCT00002791|Biological|filgrastim|
12063398|NCT00002791|Drug|dacarbazine|
12063399|NCT00002791|Drug|doxorubicin hydrochloride|
12063400|NCT00002791|Drug|ifosfamide|
12063401|NCT00002791|Drug|mesna|
12063402|NCT00002791|Procedure|conventional surgery|
12063403|NCT00002791|Radiation|brachytherapy|
12063404|NCT00002791|Radiation|intraoperative radiation therapy|
12063405|NCT00002791|Radiation|radioisotope therapy|
12063406|NCT00002790|Drug|cyclosporine|
12063407|NCT00002790|Drug|methotrexate|
12063408|NCT00002790|Drug|sirolimus|
12063409|NCT00002781|Drug|boronophenylalanine-fructose complex|
12063410|NCT00002775|Drug|docetaxel|
12063411|NCT00002775|Drug|estramustine phosphate sodium|
12063412|NCT00002767|Biological|Detox-B adjuvant|
12063413|NCT00002767|Biological|recombinant interferon alfa|
12063414|NCT00090649|Drug|DVS-233 SR|
12063415|NCT00090623|Drug|rhuFab V2 (ranibizumab)|
12063421|NCT00002744|Drug|doxorubicin hydrochloride|
12063422|NCT00002744|Drug|mercaptopurine|
12063423|NCT00002744|Drug|methotrexate|
12063424|NCT00002744|Drug|pegaspargase|
12063425|NCT00002744|Drug|prednisone|
12063426|NCT00002744|Drug|therapeutic hydrocortisone|
12063427|NCT00002744|Drug|thioguanine|
12063428|NCT00002744|Drug|vincristine sulfate|
12063429|NCT00002744|Radiation|low-LET cobalt-60 gamma ray therapy|
12063430|NCT00002744|Radiation|low-LET photon therapy|
12063431|NCT00002735|Drug|Induction chemotherapy|Cisplatin and 5-Fluorouracil
12063432|NCT00002735|Drug|cisplatin|Cisplatin 100 mg/m2 IV infusion over 90 minutes Day 1 every 21 days for 2 cycles.
12063433|NCT00002735|Drug|fluorouracil|5-Fluorouracil 1,000 mg/m2/day continuous IV infusion over 24 hours Days 1 through 5 every 21 days for 2 cycles.
12063434|NCT00002735|Radiation|low-LET cobalt-60 gamma ray therapy|180 cGy per day, Days 1-5, every week for eight weeks
12063435|NCT00002730|Drug|buthionine sulfoximine|
12063436|NCT00002730|Drug|melphalan|
12063437|NCT00002703|Radiation|high-LET heavy ion therapy|
12063438|NCT00002703|Radiation|low-LET photon therapy|
12063439|NCT00090610|Drug|Docetaxel|"For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin
~For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin"
12063440|NCT00090610|Drug|Carboplatin|"Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel.
~Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel"
12063441|NCT00090584|Drug|Tolterodine|4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
12063442|NCT00090584|Behavioral|Behavioral training|Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.
12063443|NCT00090532|Drug|AG-013,958|
12063444|NCT00090519|Drug|ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
12063445|NCT00090519|Drug|placebo|QD oral for up to 36 months
12063446|NCT00090493|Biological|MAGE-A3|vaccinations at 2- week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating the patient 3 times at 14 day intervals (vaccination #4-6: days 82, 96, and 110). Vaccines #4-6 will be identical to vaccines 1-3. Thereafter, 6 monthly vaccines will be given to further boost the anti-MM-T-cells.
12063447|NCT00090493|Biological|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|Three injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals
12063448|NCT00090480|Biological|HyperAcute - Breast cancer vaccine|Cells will be injected intradermally for four weeks for four cycles. Dosage will vary from 10 million to 100 million HAB cells.
12063449|NCT00002659|Drug|cisplatin-e therapeutic implant|
12063450|NCT00002631|Drug|chemotherapy|
12063451|NCT00002631|Drug|cisplatin|
12063452|NCT00002631|Drug|fluorouracil|
12063453|NCT00002631|Radiation|low-LET electron therapy|
12063454|NCT00002631|Radiation|low-LET photon therapy|
12063455|NCT00002628|Biological|filgrastim|
12063456|NCT00002628|Drug|carboplatin|
12063457|NCT00002628|Drug|cyclophosphamide|
12063458|NCT00002628|Drug|mesna|
12063459|NCT00002628|Drug|paclitaxel|
12063460|NCT00002628|Procedure|peripheral blood stem cell transplantation|
12063461|NCT00002622|Drug|talc|4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time
12063462|NCT00002622|Drug|Talc|4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time
12063463|NCT00002616|Biological|aldesleukin|
12063464|NCT00002616|Biological|filgrastim|
12063465|NCT00002616|Drug|carboplatin|
12063466|NCT00002616|Drug|cyclophosphamide|
12063467|NCT00002616|Drug|thiotepa|
12063468|NCT00002616|Procedure|peripheral blood stem cell transplantation|
12063469|NCT00002593|Drug|fluorouracil|Given IV as described in Arm Description
12063470|NCT00002593|Drug|leucovorin calcium|Given IV as described in Arm description.
12063471|NCT00002593|Drug|levamisole hydrochloride|Given as described in arm description
12063472|NCT00002570|Drug|fluorouracil|425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days
12063473|NCT00002570|Drug|leucovorin calcium|20 mg/m2 IV - number of cycles is determined by patient and physician
12063474|NCT00002554|Drug|busulfan|
12063475|NCT00002554|Drug|cyclophosphamide|
12063476|NCT00002554|Drug|methotrexate|
12063477|NCT00002554|Procedure|allogeneic bone marrow transplantation|
12063478|NCT00002554|Radiation|radioimmunotherapy|
12063479|NCT00002527|Drug|aspirin|
12063480|NCT00002527|Other|placebo|
12063481|NCT00002509|Biological|filgrastim|
12063482|NCT00002509|Drug|carboplatin|
12063483|NCT00002509|Drug|cyclophosphamide|
12063484|NCT00002509|Drug|etoposide|
12063485|NCT00002509|Drug|mesna|
12063486|NCT00002509|Procedure|autologous bone marrow transplantation|
12063487|NCT00002509|Procedure|peripheral blood stem cell transplantation|
12063488|NCT00090376|Drug|GPI 1485|
12063489|NCT00090363|Drug|ZD4054 15 mg|15 mg oral tablet once daily
12063490|NCT00090363|Drug|Placebo|
12063491|NCT00090363|Drug|ZD4054 10 mg|10mg oral tablet once daily
12063492|NCT00090324|Drug|quetiapine fumarate tablets|
12063493|NCT00090311|Drug|quetiapine fumarate|
12063494|NCT00090298|Drug|MK0653A, ezetimibe (+) simvastatin|
12063495|NCT00090298|Drug|Comparator: Rosuvastatin|
12063496|NCT00004915|Drug|raloxifene|
12063497|NCT00004201|Drug|carboplatin|
12063499|NCT00004201|Drug|gemcitabine hydrochloride|
12063500|NCT00004090|Drug|cisplatin|
12063501|NCT00004090|Drug|gemcitabine hydrochloride|
12063502|NCT00004029|Biological|recombinant viral vaccine therapy|
12063503|NCT00004029|Biological|sargramostim|
12063504|NCT00002489|Biological|dactinomycin|
12063505|NCT00002489|Biological|filgrastim|
12063506|NCT00002489|Drug|carboplatin|
12063507|NCT00002489|Drug|cyclophosphamide|
12063508|NCT00002489|Drug|doxorubicin hydrochloride|
12063509|NCT00002489|Drug|etoposide|
12063510|NCT00002489|Drug|leucovorin calcium|
12063511|NCT00002489|Drug|methotrexate|
12063512|NCT00002489|Drug|vincristine sulfate|
12063513|NCT00002489|Procedure|conventional surgery|
12063514|NCT00002488|Drug|cisplatin|
12063515|NCT00002488|Drug|cyclophosphamide|
12063516|NCT00002488|Drug|etoposide|
12063517|NCT00002487|Drug|dipyridamole|
12063518|NCT00002487|Drug|methotrexate|
12063519|NCT00002471|Drug|asparaginase|
12063520|NCT00002471|Drug|cyclophosphamide|
12063521|NCT00002471|Drug|cytarabine|
12063522|NCT00002471|Drug|daunorubicin hydrochloride|
12063523|NCT00002471|Drug|dexamethasone|
12063524|NCT00002471|Drug|etoposide|
12063525|NCT00002471|Drug|leucovorin calcium|
12063526|NCT00002471|Drug|methotrexate|
12063527|NCT00002471|Drug|methylprednisolone|
12063528|NCT00002471|Drug|therapeutic hydrocortisone|
12063529|NCT00002471|Drug|thiotepa|
12063530|NCT00002471|Drug|vincristine sulfate|
12063531|NCT00002458|Biological|monoclonal antibody 3F8|
12063532|NCT00090558|Drug|nitroglycerin|
12063533|NCT00090545|Drug|BAY 43-9006|400 mg BAY 43-9006 orally twice daily in 28 day cycles.
12063534|NCT00090506|Behavioral|Yoga|
12063535|NCT00090428|Behavioral|Gluten- and casein-free diet|Participants will follow a gluten-free and casein-free diet for 18 weeks. All children received individual EIBI interventions to decrease the confound of different types of therapies.
12063536|NCT00090428|Behavioral|Placebo controlled diet|Participants will follow a gluten-free and casein-free diet for 18 weeks. They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response. They remain on the gluten free and casein free diet for the entire study period.
12063537|NCT00090415|Behavioral|Intensive behavioral therapy|Participants will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study.
12063538|NCT00090285|Biological|(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine|0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study
12063539|NCT00090285|Biological|Comparator: placebo (unspecified)|0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study
12063540|NCT00090272|Drug|MK0826, ertapenem sodium|
12063541|NCT00090272|Drug|Comparator: cefotetan|
12063542|NCT00090259|Drug|Losartan 50 mg|50-mg losartan oral tablet
12063543|NCT00090259|Drug|Losartan 150 mg|100-mg losartan oral tablet + 50-mg losartan oral tablet
12063544|NCT00090246|Drug|MK0869, aprepitant|
12063545|NCT00090246|Drug|Comparator: ondansetron IV|
12063546|NCT00090233|Biological|Rotateq™|3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
12063547|NCT00090233|Biological|Comparator: Placebo|3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
12063548|NCT00090220|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1
12063549|NCT00090220|Biological|Comparator: Placebo|Placebo intramuscular injection in three 0.5 mL doses over 6 months.
12063550|NCT00090207|Drug|MK0869, aprepitant / Duration of Treatment: 3 days|
12063551|NCT00090207|Drug|Comparator: ondansetron / Duration of Treatment: 4 days|
12063552|NCT00090181|Drug|MK0663, etoricoxib / Duration of Treatment: 4 weeks|
12063553|NCT00090181|Drug|Comparator: diclofenac / Duration of Treatment: 4 weeks|
12063554|NCT00090168|Drug|MK0653A , ezetimibe (+) simvastatin|
12063555|NCT00090168|Drug|Comparator: atorvastatin|
12063556|NCT00090168|Drug|Duration of Treatment: 6 weeks|
12063557|NCT00090155|Drug|MK0869, aprepitant|
12063558|NCT00090155|Drug|Comparator: ondansetron IV|
12063559|NCT00004026|Drug|CT-2584|
12063560|NCT00004026|Drug|chemotherapy|
12063561|NCT00004009|Drug|tipifarnib|
12063562|NCT00003989|Biological|ISIS 3521|
12063563|NCT00003962|Biological|aldesleukin|
12063564|NCT00003778|Drug|dolastatin 10|
12063565|NCT00090402|Dietary Supplement|Fish Oil|Fish oil capsule
12063566|NCT00090402|Dietary Supplement|Lipoic Acid|Lipoic acid capsule
12063567|NCT00090402|Other|Fish Oil Placebo|Soybean oil placebo capsule
12063568|NCT00090402|Other|Lipoic Acid Placebo|Lipoic acid (LA) placebo capsule containing no LA
12063569|NCT00090389|Procedure|Chinese Acupuncture|
12063570|NCT00090337|Procedure|acupuncture therapy|Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks
12063571|NCT00090337|Procedure|standard follow-up care|Patients undergo standard care
12063572|NCT00090194|Biological|Immune Globulin Intravenous (Human), 10%|
12063573|NCT00090142|Drug|Comparator: Montelukast|Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
12063574|NCT00090142|Drug|Comparator: Placebo|Placebo tablet administered orally as a single witnessed dose before exercise challenge
12063669|NCT00002783|Procedure|conventional surgery|
12063670|NCT00002755|Biological|filgrastim|
12063671|NCT00002755|Drug|CMF regimen|
12063672|NCT00002755|Drug|cyclophosphamide|
12063575|NCT00090129|Drug|Onercept|Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
12063576|NCT00090129|Drug|Placebo|Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
12063577|NCT00090116|Drug|Neramexane|
12063578|NCT00090103|Drug|dutasteride 0.5mg once daily for 4 years|combination or single agent
12063579|NCT00090103|Drug|tamsulosin 0.4mg once daily for 4 years|combination agent or single agent
12063580|NCT00090077|Drug|GW695634|
12063581|NCT00003654|Drug|patent blue V dye|
12063582|NCT00003654|Procedure|lymphangiography|
12063583|NCT00003654|Procedure|radionuclide imaging|
12063584|NCT00003654|Procedure|sentinel lymph node biopsy|
12063585|NCT00003654|Radiation|technetium Tc 99m sulfur colloid|
12063586|NCT00003601|Drug|fenretinide|
12063587|NCT00003601|Drug|tretinoin|
12063588|NCT00003588|Biological|Ad5CMV-p53 gene|
12063589|NCT00003588|Procedure|laparoscopic surgery|
12063590|NCT00003519|Drug|cyclophosphamide|
12063591|NCT00003519|Drug|docetaxel|
12063592|NCT00003519|Drug|doxorubicin hydrochloride|
12063593|NCT00003406|Drug|carboplatin|
12063594|NCT00003406|Drug|docetaxel|
12063595|NCT00003406|Drug|ifosfamide|
12063596|NCT00003406|Procedure|autologous bone marrow transplantation|
12063597|NCT00003406|Procedure|bone marrow ablation with stem cell support|
12063598|NCT00003406|Procedure|peripheral blood stem cell transplantation|
12063599|NCT00003390|Drug|irofulven|
12063600|NCT00003378|Drug|carboplatin|
12063601|NCT00003378|Drug|gemcitabine hydrochloride|
12063602|NCT00003378|Drug|paclitaxel|
12063603|NCT00003362|Biological|QS21|
12063604|NCT00003362|Biological|gp100 antigen|
12063605|NCT00003362|Biological|incomplete Freund's adjuvant|
12063606|NCT00003362|Biological|sargramostim|
12063607|NCT00003362|Biological|tyrosinase peptide|
12063608|NCT00003315|Biological|sargramostim|
12063609|NCT00003315|Drug|liposomal amphotericin B|
12063610|NCT00003304|Drug|temozolomide|
12063611|NCT00090090|Drug|Elsamitrucin|
12063612|NCT00090064|Drug|3,4-methylenedioxymethamphetamine (MDMA)|125 mg and 62.5 mg MDMA
12063613|NCT00090064|Drug|lactose (placebo|two capsules placebo matched in weight with MDMA capsules
12063614|NCT00090064|Behavioral|Psychotherapy|Psychotherapy provided by a team of two co-therapists
12063615|NCT00090051|Drug|Rituximab|Intravenous repeating dose
12063616|NCT00090051|Drug|Fludarabine Phosphate|Intravenous repeating dose
12063617|NCT00090051|Drug|Cyclophosphamide|Intravenous repeating dose
12063618|NCT00003279|Biological|BCG vaccine|
12063619|NCT00003279|Biological|monoclonal antibody BEC2|
12063620|NCT00003260|Drug|FOLFIRI regimen|
12063621|NCT00003260|Drug|FOLFOX regimen|
12063622|NCT00003260|Drug|fluorouracil|
12063623|NCT00003260|Drug|irinotecan hydrochloride|
12063624|NCT00003260|Drug|leucovorin calcium|
12063625|NCT00003260|Drug|oxaliplatin|
12063626|NCT00003237|Drug|cisplatin|
12063627|NCT00003237|Drug|paclitaxel|
12063628|NCT00003237|Procedure|surgical procedure|
12063629|NCT00003229|Biological|aldesleukin|
12063630|NCT00003229|Biological|gp100 antigen|
12063631|NCT00003229|Biological|tyrosinase peptide|
12063632|NCT00003224|Biological|QS21|vaccine adjuvant
12063633|NCT00003224|Biological|IFA (incomplete Freund's adjuvant)|Peptides emulsified in IFA.
12063634|NCT00003224|Biological|p946|This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
12063635|NCT00003224|Biological|p946/tet-p|This peptide is a longer version of p946 (gp100 [280-288]) sythesized colinearly with the tetanus helper peptide (Tet-p)
12063636|NCT00003224|Biological|Tet-p|modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
12063637|NCT00090038|Drug|rituximab|Dose, schedule,and duration specified in protocol
12063638|NCT00003151|Dietary Supplement|bismuth subcitrate|
12063639|NCT00003151|Drug|amoxicillin|
12063640|NCT00003151|Drug|clarithromycin|
12063641|NCT00003151|Drug|metronidazole hydrochloride|
12063642|NCT00003151|Drug|omeprazole|
12063643|NCT00003151|Drug|tetracycline hydrochloride|
12063644|NCT00003147|Biological|Ad5CMV-p53 gene|
12063645|NCT00003136|Biological|filgrastim|
12063646|NCT00003136|Drug|amifostine trihydrate|
12063647|NCT00003136|Drug|carboplatin|
12063648|NCT00003136|Drug|cyclophosphamide|
12063649|NCT00003136|Procedure|peripheral blood stem cell transplantation|
12063650|NCT00003131|Drug|chemotherapy|
12063651|NCT00003131|Drug|gemtuzumab ozogamicin|
12063652|NCT00002969|Drug|paclitaxel|
12063653|NCT00002960|Biological|recombinant adenovirus-p53 SCH-58500|
12063654|NCT00002888|Drug|cisplatin|
12063655|NCT00002888|Drug|fluorouracil|
12063656|NCT00002888|Drug|paclitaxel|
12063657|NCT00002881|Drug|flutamide|
12063658|NCT00002881|Drug|goserelin acetate|
12063659|NCT00002881|Drug|leuprolide acetate|
12063660|NCT00002881|Drug|suramin|
12063661|NCT00002881|Drug|therapeutic hydrocortisone|
12063662|NCT00002881|Procedure|orchiectomy|
12063663|NCT00002879|Drug|cladribine|
12063664|NCT00002845|Biological|aldesleukin|
12063665|NCT00002783|Drug|cisplatin|
12063673|NCT00002755|Drug|doxorubicin hydrochloride|
12063674|NCT00002755|Drug|fluorouracil|
12063675|NCT00002755|Drug|methotrexate|
12063676|NCT00002755|Drug|tamoxifen citrate|
12063677|NCT00002755|Drug|thiotepa|
12063678|NCT00002755|Procedure|autologous bone marrow transplantation|
12063679|NCT00002755|Procedure|peripheral blood stem cell transplantation|
12063680|NCT00002755|Radiation|low-LET cobalt-60 gamma ray therapy|
12063681|NCT00002755|Radiation|low-LET electron therapy|
12063682|NCT00002755|Radiation|low-LET photon therapy|
12063683|NCT00002742|Drug|amphotericin B deoxycholate|
12063684|NCT00002742|Drug|nystatin|
12063685|NCT00002711|Drug|chemotherapy|
12063686|NCT00002711|Drug|cisplatin|
12063687|NCT00002711|Drug|paclitaxel|
12063688|NCT00002711|Radiation|low-LET electron therapy|
12063689|NCT00002711|Radiation|low-LET photon therapy|
12063690|NCT00090025|Drug|becatecarin|Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle
12063691|NCT00090025|Drug|5-Fluorouracil Plus Leucovorin|5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle
12063692|NCT00090012|Drug|Olanzapine|
12063693|NCT00090012|Drug|Quetiapine|
12063694|NCT00089999|Drug|Lapatinib|
12063695|NCT00089986|Drug|Intravenous GR270773- Phospholipid Emulsion|
12063696|NCT00089986|Other|Placebo|
12063697|NCT00005024|Drug|carboplatin|
12063698|NCT00005024|Drug|cyclophosphamide|
12063699|NCT00005024|Drug|doxorubicin hydrochloride|
12063700|NCT00005024|Drug|granisetron hydrochloride|
12063701|NCT00004906|Biological|filgrastim|
12063702|NCT00004906|Drug|anastrozole|
12063703|NCT00004906|Drug|carboplatin|
12063704|NCT00004906|Drug|cisplatin|
12063705|NCT00004906|Drug|cyclophosphamide|
12063706|NCT00004906|Drug|docetaxel|
12063707|NCT00004906|Drug|doxorubicin hydrochloride|
12063708|NCT00004906|Drug|etoposide|
12063709|NCT00004906|Drug|pamidronate disodium|
12063710|NCT00004906|Drug|thiotepa|
12063711|NCT00004906|Procedure|peripheral blood stem cell transplantation|
12063712|NCT00002674|Biological|filgrastim|
12063713|NCT00002674|Drug|cytarabine|
12063714|NCT00002674|Drug|etoposide|
12063715|NCT00002674|Drug|hydroxyurea|
12063716|NCT00002674|Drug|mitoxantrone hydrochloride|
12063717|NCT00002674|Procedure|peripheral blood stem cell transplantation|
12063718|NCT00002634|Biological|filgrastim|
12063719|NCT00002634|Biological|monoclonal antibody 3F8|
12063720|NCT00002634|Drug|cisplatin|
12063721|NCT00002634|Drug|cyclophosphamide|
12063722|NCT00002634|Drug|doxorubicin hydrochloride|
12063723|NCT00002634|Drug|etoposide|
12063724|NCT00002634|Drug|mesna|
12063725|NCT00002634|Drug|perfosfamide|
12063726|NCT00002634|Drug|vincristine sulfate|
12063727|NCT00002634|Procedure|autologous bone marrow transplantation|
12063728|NCT00002634|Procedure|in vitro-treated bone marrow transplantation|
12063729|NCT00002634|Radiation|low-LET cobalt-60 gamma ray therapy|
12063730|NCT00002634|Radiation|low-LET photon therapy|
12063731|NCT00002634|Radiation|radioisotope therapy|
12063732|NCT00002579|Drug|CMF regimen|
12063733|NCT00002579|Drug|cyclophosphamide|
12063734|NCT00002579|Drug|fluorouracil|
12063735|NCT00002579|Drug|methotrexate|
12063736|NCT00002579|Drug|tamoxifen citrate|
12063737|NCT00002579|Procedure|conventional surgery|
12063738|NCT00002579|Radiation|radiation therapy|
12063739|NCT00002510|Biological|filgrastim|
12063740|NCT00002510|Drug|cyclophosphamide|
12063741|NCT00002510|Drug|etoposide|
12063742|NCT00002510|Drug|mesna|
12063743|NCT00002510|Procedure|peripheral blood stem cell transplantation|
12063744|NCT00002510|Radiation|radiation therapy|
12063745|NCT00002499|Drug|asparaginase|
12063746|NCT00002499|Drug|cytarabine|
12063747|NCT00002499|Drug|daunorubicin hydrochloride|
12063748|NCT00002499|Drug|dexamethasone|
12063749|NCT00002499|Drug|methotrexate|
12063750|NCT00002499|Drug|prednisone|
12063751|NCT00002499|Drug|vincristine sulfate|
12063752|NCT00002499|Radiation|radiation therapy|
12063753|NCT00002498|Drug|CMF regimen|
12063754|NCT00002498|Drug|cyclophosphamide|
12063755|NCT00002498|Drug|fluorouracil|
12063756|NCT00002498|Drug|methotrexate|
12063757|NCT00002498|Drug|mitoxantrone hydrochloride|
12063758|NCT00002493|Drug|cisplatin|
12063759|NCT00002493|Drug|doxorubicin hydrochloride|
12063760|NCT00002493|Radiation|low-LET photon therapy|
12063761|NCT00002479|Drug|tretinoin|
12063762|NCT00089973|Drug|Ispinesib|Given intravenously at a dose of 18 milligram (mg)/ meter square (m^2).
12063763|NCT00089960|Drug|AMG 706|AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.
12063764|NCT00089947|Drug|Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]|
12063765|NCT00089921|Drug|SCIO-469|60 mg capsule three times daily for 12 weeks
12063766|NCT00089921|Drug|SCIO-469|30 mg capsule three times daily for 12 weeks
12063767|NCT00089921|Drug|Placebo|2 capsules three times daily and one tablet daily
12063768|NCT00089921|Drug|SCIO-469|100 mg tablet once daily for 12 weeks
12063769|NCT00004900|Biological|filgrastim|
12063770|NCT00004900|Drug|anastrozole|
12063771|NCT00004900|Drug|carboplatin|
12063772|NCT00004900|Drug|cisplatin|
12063773|NCT00004900|Drug|cyclophosphamide|
12063774|NCT00004900|Drug|etoposide|
12063775|NCT00004900|Drug|thiotepa|
12064524|NCT00004169|Drug|carboplatin|
12063776|NCT00004900|Procedure|peripheral blood stem cell transplantation|
12063777|NCT00004900|Radiation|radiation therapy|
12063778|NCT00004182|Drug|irinotecan hydrochloride|
12063779|NCT00004136|Procedure|Radiofrequency Ablation|Tumors heated to target temperature by electrodes for maximum of 20 minutes
12063780|NCT00004042|Biological|monoclonal antibody F19|
12063781|NCT00004042|Radiation|iodine I 131 monoclonal antibody F19|
12063782|NCT00003974|Biological|lung tumor associated antigen|
12063783|NCT00003974|Drug|DetoxPC|
12063784|NCT00003974|Drug|chemotherapy|
12063785|NCT00003974|Drug|cyclophosphamide|
12063786|NCT00089908|Biological|rDEN1delta30|Live attenuated rDEN1delta30 vaccine
12063787|NCT00089908|Biological|Placebo|Placebo for rDEN1delta30
12063788|NCT00089895|Drug|Eptifibatide (Integrilin)|intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG [coronary artery bypass graft]); second bolus of 180 mcg/kg administered 10 minutes after first bolus.
12063789|NCT00089895|Drug|Placebo|intravenous; delivery to match eptifibatide to maintain blind
12063790|NCT00089882|Procedure|APOE Genetic susceptibility testing|
12063791|NCT00089869|Drug|olanzapine|
12063792|NCT00089869|Drug|atomoxetine|
12063793|NCT00089869|Drug|placebo|
12063794|NCT00089856|Biological|Immunotherapy with allogeneic prostate vaccine|Immunotherapy with allogeneic prostate vaccine
12063795|NCT00089856|Drug|Chemotherapy (Taxotere and prednisone)|Chemotherapy (Taxotere and prednisone)
12063796|NCT00003951|Drug|exatecan mesylate|
12063797|NCT00003897|Biological|gp100 antigen|
12063798|NCT00003897|Biological|sargramostim|
12063799|NCT00003885|Drug|arsenic trioxide|
12063800|NCT00003776|Biological|filgrastim|
12063801|NCT00003776|Drug|cisplatin|
12063802|NCT00003776|Drug|doxorubicin hydrochloride|
12063803|NCT00003776|Drug|ifosfamide|
12063804|NCT00003776|Drug|leucovorin calcium|
12063805|NCT00003776|Drug|methotrexate|
12063806|NCT00003776|Drug|trimetrexate glucuronate|
12063807|NCT00003776|Procedure|surgical procedure|
12063808|NCT00003751|Drug|penicillamine|
12063809|NCT00003751|Radiation|radiation therapy|
12063810|NCT00089843|Drug|Testosterone|Testosterone patch 150mcg daily
12063811|NCT00089843|Drug|Actonel (risedronate)|Actonel (risedronate) 35mg PO one time weekly
12063812|NCT00089843|Drug|Placebo Actonel (risedronate)|Placebo tablet identical in appearance to active Actonel (risedronate) tablet
12063813|NCT00089843|Drug|Placebo testosterone|Placebo patch identical in appearance to testosterone patch
12063814|NCT00089830|Drug|MSI-1256F (Squalamine Lactate)|
12063815|NCT00089804|Drug|abetimus sodium (LJP 394) and/or placebo solution|300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks
12063816|NCT00089804|Drug|abetimus sodium (LJP 394)|900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.
12063817|NCT00089804|Drug|Phosphate-buffered saline|A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks
12063818|NCT00003709|Drug|carbendazim|Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment.
12063819|NCT00003686|Drug|pilocarpine hydrochloride|Pilocarpine 5 mg po qid x 4 weeks
12063820|NCT00003686|Drug|Placebo|Placebo 5 mg po qid x 4 weeks
12063821|NCT00003684|Drug|theophylline|
12063822|NCT00003684|Procedure|quality-of-life assessment|
12063823|NCT00003626|Drug|dolastatin 10|
12063824|NCT00003556|Biological|ALVAC-hB7.1|
12063825|NCT00003556|Biological|canarypox-hIL-12 melanoma vaccine|
12063826|NCT00089791|Drug|placebo|Placebo administered by subcutaneous injection
12063827|NCT00089791|Drug|Denosumab|Denosumab 60 mg administered by subcutaneous injection
12063828|NCT00089752|Device|Continuous Positive Airway Pressure (CPAP) Treatment|CPAP device used at night
12063829|NCT00089752|Device|Sham CPAP device - CPAP device with pressure delivered <1 cm H20|Sham CPAP device used at night
12063830|NCT00003555|Drug|amifostine trihydrate|
12063831|NCT00003555|Drug|paclitaxel|
12063832|NCT00003543|Biological|monoclonal antibody A33|
12063833|NCT00003543|Drug|carmustine|
12063834|NCT00003543|Drug|fluorouracil|
12063835|NCT00003543|Drug|streptozocin|
12063836|NCT00003543|Drug|vincristine sulfate|
12063837|NCT00003400|Biological|filgrastim|
12063838|NCT00003400|Drug|carmustine|
12063839|NCT00003400|Drug|cisplatin|
12063840|NCT00003400|Drug|melphalan|
12063841|NCT00003400|Drug|vinorelbine tartrate|
12063842|NCT00003400|Procedure|peripheral blood stem cell transplantation|
12063843|NCT00003395|Drug|arsenic trioxide|
12063844|NCT00003380|Drug|etoposide|
12063845|NCT00003380|Drug|pegylated liposomal doxorubicin hydrochloride|
12063846|NCT00003360|Radiation|iodine I 131 monoclonal antibody A33|
12063847|NCT00003357|Biological|GM2-KLH vaccine|
12063848|NCT00003357|Biological|QS21|
12063849|NCT00003348|Drug|O6-benzylguanine|
12063850|NCT00003348|Drug|carmustine|
12063851|NCT00003340|Drug|cyclophosphamide|
12063852|NCT00003340|Drug|topotecan hydrochloride|
12063853|NCT00003312|Radiation|iodine I 125|
12063854|NCT00089778|Drug|117-126:Fibroblast growth factor 5 (FGF-5)|Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
12063855|NCT00089778|Drug|Fibroblast growth factor 5 (FGF-5):172-176/217-220|Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
12063856|NCT00089778|Other|IL-2|720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
12063857|NCT00089765|Drug|Ranibizumab|
12063858|NCT00003294|Biological|filgrastim|
12063859|NCT00003294|Drug|amifostine trihydrate|
12063860|NCT00003294|Drug|carboplatin|
12063861|NCT00003294|Drug|paclitaxel|
12063862|NCT00003284|Biological|filgrastim|
12063863|NCT00003284|Drug|carboplatin|
12063864|NCT00003284|Drug|etoposide|
12063865|NCT00003284|Drug|ifosfamide|
12063866|NCT00003284|Drug|paclitaxel|
12063867|NCT00003284|Procedure|peripheral blood stem cell transplantation|
12063868|NCT00003284|Radiation|radiation therapy|
12063869|NCT00003251|Drug|amifostine trihydrate|
12063870|NCT00003251|Drug|cisplatin|
12063871|NCT00003251|Drug|paclitaxel|
12063872|NCT00003251|Radiation|radiation therapy|
12063873|NCT00003220|Drug|bryostatin 1|
12063874|NCT00003200|Drug|Taxotere|
12063875|NCT00003200|Radiation|Radiation therapy|
12063876|NCT00089726|Biological|CG8123|
12063877|NCT00089726|Drug|Cyclophosphamide|
12063878|NCT00089713|Drug|alagebrium chloride (ALT-711)|
12063879|NCT00089700|Drug|TNX-355|
12063880|NCT00003197|Dietary Supplement|green tea extract|
12063881|NCT00003123|Drug|amifostine trihydrate|
12063882|NCT00003115|Drug|hydromorphone hydrochloride|
12063883|NCT00003102|Radiation|iodine I 131 chimeric monoclonal antibody G-250|
12063884|NCT00003058|Drug|troglitazone|
12063885|NCT00003044|Drug|cisplatin-e therapeutic implant|
12063886|NCT00003025|Biological|vitespen|
12063887|NCT00003003|Biological|sargramostim|
12063888|NCT00003003|Drug|mitomycin C|
12063889|NCT00003003|Drug|mitoxantrone hydrochloride|
12063890|NCT00002955|Drug|fluorouracil|
12063891|NCT00002955|Drug|leucovorin calcium|
12063892|NCT00002955|Drug|trimetrexate glucuronate|
12063893|NCT00002933|Drug|irinotecan hydrochloride|Irinotecan IV at a starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study. Patients attaining a complete response may receive additional courses of treatment. Patients are followed until death.
12063894|NCT00089687|Drug|GBR 12909|
12063895|NCT00089674|Drug|AMG 162|60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
12063896|NCT00089674|Drug|Placebo|60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
12063897|NCT00089661|Drug|Placebo|60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
12063898|NCT00089661|Drug|AMG 162 / Denosumab|60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
12063899|NCT00089648|Drug|Sunitinib|50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol
12063900|NCT00089635|Drug|Panitumumab|Administered by intravenous infusion
12063901|NCT00002914|Drug|piritrexim|
12063902|NCT00002909|Drug|chemotherapy|
12063903|NCT00002909|Drug|oral sodium phenylbutyrate|
12063904|NCT00002890|Biological|lintuzumab|
12063905|NCT00002865|Biological|filgrastim|
12063906|NCT00002865|Drug|cyclophosphamide|
12063907|NCT00002865|Drug|cytarabine|
12063908|NCT00002865|Drug|dexamethasone|
12063909|NCT00002865|Drug|doxorubicin hydrochloride|
12063910|NCT00002865|Drug|etoposide|
12063911|NCT00002865|Drug|ifosfamide|
12063912|NCT00002865|Drug|leucovorin calcium|
12063913|NCT00002865|Drug|mesna|
12063914|NCT00002865|Drug|methotrexate|
12063915|NCT00002865|Drug|therapeutic hydrocortisone|
12063916|NCT00002865|Drug|vincristine sulfate|
12063917|NCT00002865|Radiation|low-LET cobalt-60 gamma ray therapy|
12063918|NCT00002865|Radiation|low-LET photon therapy|
12063919|NCT00002749|Drug|carboplatin|
12063920|NCT00002655|Procedure|cryosurgery|
12063921|NCT00002635|Biological|filgrastim|
12063922|NCT00002635|Drug|aminocamptothecin|
12063923|NCT00002619|Biological|filgrastim|
12063924|NCT00002619|Drug|carboplatin|
12063925|NCT00002619|Drug|thiotepa|
12063926|NCT00002619|Procedure|autologous bone marrow transplantation|
12063927|NCT00002619|Procedure|peripheral blood stem cell transplantation|
12063928|NCT00002609|Biological|lintuzumab|
12063929|NCT00002609|Drug|cytarabine|
12063930|NCT00002609|Drug|idarubicin|
12063931|NCT00002585|Drug|pyrazoloacridine|
12063932|NCT00089596|Procedure|Expansion of umbilical cord stem cells|
12063933|NCT00089583|Drug|LEXIVA (GW433908)|Fosamprenavir suspension or tablet bid
12063934|NCT00089583|Drug|Ritonavir|Ritonavir solution bid
12063935|NCT00005626|Drug|Irinotecan|Irinotecan as outlined in treatment arm
12063936|NCT00005607|Drug|FOLFIRI regimen|
12063937|NCT00005607|Drug|fluorouracil|
12063938|NCT00005607|Drug|irinotecan hydrochloride|
12063939|NCT00005607|Drug|leucovorin calcium|
12063940|NCT00002574|Biological|recombinant interferon alfa|
12063941|NCT00002574|Drug|omacetaxine mepesuccinate|
12063942|NCT00002562|Drug|paclitaxel|
12063943|NCT00002507|Drug|mitomycin C|
12063944|NCT00002507|Drug|porfiromycin|
12063945|NCT00002507|Radiation|brachytherapy|
12063946|NCT00002507|Radiation|radiation therapy|
12063947|NCT00089622|Drug|Intravenous Levodopa|
12063948|NCT00089622|Drug|Lisuride Transdermal System|
12063949|NCT00089609|Drug|Docetaxel|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days.
12063950|NCT00089609|Drug|Thalidomide|Thalidomide 200 mg by mouth daily throughout the cycle.
12063951|NCT00089609|Drug|Prednisone|Prednisone 10 mg by mouth daily throughout the cycle.
12063952|NCT00089609|Biological|bevacizumab|Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
12063953|NCT00089609|Genetic|polymorphism analysis|Two buffy coat tubes (two 7mL blue tiger top tubes) will be obtained and wrapped in foil when the patient enters onto the study. DNA (deoxyribonucleic acid) will be isolated only for the purpose of genotype analysis of enzymes with putative relevance for docetaxel or thalidomide disposition.
12063954|NCT00089609|Other|immunoenzyme technique|The PBMC (peripheral blood mononuclear cells) of patients will be analyzed pre-treatment and post cycle 2 for any changes in the function of regulatory T cells. The following analysis will be performed: flow cytometry analysis, CD4 CD25 T cell enrichment, and immunosuppression assay.
12063955|NCT00089609|Other|laboratory biomarker analysis|Serum and urine samples will be collected at baseline and monthly to measure VEGF (vascular endothelial growth factor) levels.
12063956|NCT00089609|Other|pharmacological study|Plasma concentrations of docetaxel and thalidomide will be determined to assess interactions between docetaxel (and thalidomide) and the concomitant therapy.The analysis will be performed using a validated method based on liquid chromotography with mass-spectrometric detection.
12063957|NCT00089570|Drug|terlipressin|
12063958|NCT00089570|Drug|Placebo|
12063959|NCT00089557|Drug|Capsaicin Dermal Patch|
12063960|NCT00089544|Drug|Dacarbazine|Given IV
12063961|NCT00089544|Drug|Doxorubicin Hydrochloride|Given IV
12063962|NCT00089544|Biological|Filgrastim|Given subcutaneously
12063963|NCT00089544|Drug|Ifosfamide|Given IV
12063964|NCT00089544|Other|Laboratory Biomarker Analysis|Correlative studies
12063965|NCT00089544|Radiation|Radiation Therapy|Undergo radiotherapy
12063966|NCT00089544|Drug|Thalidomide|Given orally
12063967|NCT00089544|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
12063968|NCT00005591|Biological|cetuximab|
12063969|NCT00005591|Drug|gemcitabine hydrochloride|
12063970|NCT00005076|Biological|cetuximab|
12063971|NCT00005076|Drug|irinotecan hydrochloride|
12063972|NCT00005070|Drug|irofulven|
12063973|NCT00005057|Biological|adenovirus RSV-TK|
12063974|NCT00005057|Drug|ganciclovir|
12063975|NCT00005056|Drug|bryostatin 1|
12063976|NCT00004937|Drug|acridine carboxamide|
12063977|NCT00004219|Drug|granisetron hydrochloride|
12063978|NCT00004219|Drug|lerisetron|
12063979|NCT00004219|Radiation|radiation therapy|
12063980|NCT00004215|Biological|filgrastim|
12063981|NCT00004215|Biological|leridistim|
12063982|NCT00004215|Drug|cytarabine|
12063983|NCT00004215|Drug|daunorubicin hydrochloride|
12063984|NCT00004207|Drug|liposomal daunorubicin citrate|
12063985|NCT00089531|Drug|VRC-HIVDNA016-00-VP|
12063986|NCT00089518|Drug|Valsartan|
12063987|NCT00089505|Drug|Emtricitabine|200 mg taken orally
12063988|NCT00089505|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200/300 mg taken orally
12063989|NCT00089505|Drug|Lopinavir/Ritonavir|400/100 mg taken orally
12063990|NCT00089505|Drug|Nevirapine|200 mg taken orally
12063991|NCT00089505|Drug|Tenofovir disoproxil fumarate|300 mg taken orally
12063992|NCT00089492|Drug|Optimized Background ARVs|As prescribed
12063993|NCT00089492|Drug|enfuvirtide [Fuzeon]|180mg sc once daily for 48 weeks
12063994|NCT00089492|Drug|enfuvirtide [Fuzeon]|90mg sc bid for 48 weeks
12063995|NCT00089479|Drug|capecitabine [Xeloda]|825mg/m2 po bid on days 1-14 of each 3 week cycle
12063996|NCT00089479|Drug|Taxotere|75mg/m2 iv on day 1 of each 3 week cycle
12063997|NCT00089479|Drug|Taxotere|100mg/m2 iv on day 1 of each 3 week cycle
12063998|NCT00089466|Drug|AMD11070|AMD11070 taken daily. Dosage dependent on arm.
12063999|NCT00089453|Drug|Dexamethasone|Dexamthasone 40mg every day, days -5 to -1 only will be given.
12064000|NCT00089453|Drug|Cyclophosphamide|A dose of 60mg/kg (using calculated body weight - see appendix A.) will be infused on day-3, and -2. Cyclophosphamide is administered by intravenous infusion over 2-4 hrs in 250 mLs of Normal Saline (0.9%) or D5W Standard MESNA (60% or 36mg/kg) protection to prevent hemorrhagic cystitis will be given on day -3, -2 and -1.
12064001|NCT00089453|Drug|Melphalan|Melphalan will be given as a single dose of 140mg/m2 on day -1. Subject weighing more than 60kg will be dosed according to their calculated body weight.Melphalan will be diluted in normal saline(0.9%NaCl) to a concentration of 1.5mg/ml. A dose of 140mg/m2 will be administered intravenously over a period <or= 20 minutes on day -1.
12064002|NCT00089453|Drug|Fludarabine|dose of 1.0mg/m2 on days -8,-5,-2.
12064003|NCT00089453|Drug|Bortezomide|A dose of 1.0mg/m2 will be given as a bolus dose on day-8, day-5 and day-2 as per standard practice
12064004|NCT00089453|Procedure|Leukapheresis|On day 0 to collect donor cells for NK cell isolation
12064005|NCT00089453|Drug|Interleukin|2 at 3x10x6 IU on days +1 to 13.
12064006|NCT00089453|Procedure|Infusion #1|Infusion of donor NK Cells #1 on day 0
12064007|NCT00089453|Procedure|Leukapheresis #2|on day +2
12064008|NCT00089453|Procedure|Infusion #2|on day +2
12064009|NCT00089453|Procedure|Auto Graft|on day +14
12064010|NCT00089440|Drug|Aripiprazole|
12064011|NCT00089427|Drug|IL13-PE38QQR|
12064012|NCT00089427|Procedure|Surgery for placement|
12064013|NCT00089427|Procedure|Radiation therapy|
12064014|NCT00089427|Drug|Temozolomide with radiation therapy|
12064015|NCT00089414|Drug|Ethinyl Estradiol/Drospirenone|Drug administered dependent upon arm.
12064016|NCT00089414|Drug|Placebo|
12064017|NCT00089414|Drug|CDB 2914|
12064018|NCT00089401|Drug|isolated perfusion|
12064019|NCT00089401|Drug|melphalan|
12064020|NCT00089401|Procedure|conventional surgery|
12064021|NCT00089388|Drug|cilengitide|Given IV
12064022|NCT00089362|Drug|alvespimycin hydrochloride|Given IV
12064525|NCT00004169|Drug|cyclophosphamide|
12064023|NCT00089362|Other|laboratory biomarker analysis|Correlative studies
12064024|NCT00089362|Other|pharmacological study|Correlative studies
12064025|NCT00089349|Biological|alemtuzumab|Given IV
12064026|NCT00089349|Drug|methotrexate|Given IV
12064027|NCT00089349|Drug|mercaptopurine|Given PO
12064028|NCT00089323|Procedure|Bone Marrow Aspiration|
12064029|NCT00089310|Radiation|technetium-99|0.25 mCi in 4 equal doses
12064030|NCT00089297|Biological|Cetuximab|"Induction: An initial dose of cetuximab (C225) 400 mg/m2 (over 2 hours) was given week 1 only. Then, C225 was administered at dose of 250 mg/m2 (over 1 hour) weekly for 5 weeks.
~Concurrent Chemoradiation (Weeks 9-13): C225 was administered at 250 mg/m2/wk (over 1 hour).
~Restaging Biopsy of Primary Site (Week 14): Patients with positive biopsy of the primary site at week 7 or patients without a clinical complete response at the primary site after induction therapy were scheduled for re-biopsy of the primary site at week 14 after concurrent therapy (50 Gy). If the biopsy were negative after concurrent therapy, the patients were scheduled to continue concurrent therapy to complete radiation (68-72 Gy).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
12064031|NCT00089297|Drug|Carboplatin|"Induction Therapy (Week 1-6): The induction chemotherapy starting at week 1 included paclitaxel 90 mg/m2 IV over 1 hour weekly and carboplatin AUC = 2 IV over 30 minutes weekly. The paclitaxel and carboplatin doses were given on the same day, 1 hour after C225 dose was administered. For paclitaxel and carboplatin therapy, rounding of doses (to next decimal if above 0.5 and to lower decimal if below 0.5) was permitted.
~Concurrent Chemoradiation (Weeks 9-13): Concurrent chemotherapy was consisted of paclitaxel following cetuximab at 30 mg/m2/wk (over 1 hour) and carboplatin following paclitaxel at AUC = 1/week (over 15 minutes).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
12064032|NCT00089297|Drug|Paclitaxel|"Induction Therapy (Week 1-6): The induction chemotherapy starting at week 1 included paclitaxel 90 mg/m2 IV over 1 hour weekly and carboplatin AUC = 2 IV over 30 minutes weekly. The paclitaxel and carboplatin doses were given on the same day, 1 hour after C225 dose was administered. For paclitaxel and carboplatin therapy, rounding of doses (to next decimal if above 0.5 and to lower decimal if below 0.5) was permitted.
~Concurrent Chemoradiation (Weeks 9-13): Concurrent chemotherapy was consisted of paclitaxel following cetuximab at 30 mg/m2/wk (over 1 hour) and carboplatin following paclitaxel at AUC = 1/week (over 15 minutes).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
12064033|NCT00089297|Radiation|Radiation therapy|"Concurrent Chemoradiation (Weeks 9-13): Radiation was given at 200cGy/d/5 weeks for a total dose of 50Gy (5000 cGy). Patients with a negative initial biopsy at week 7 were scheduled to continue concurrent therapy to complete radiation (68-72Gy).
~If the biopsy was negative after concurrent therapy, the patients were scheduled to continue concurrent therapy to complete radiation (68-72 Gy).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
12064034|NCT00089284|Drug|Rituxan|Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
12064035|NCT00089284|Drug|motexafin gadolinium|Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
12064036|NCT00089284|Drug|111Indium-Zevalin and 90Yttrium-Zevalin|Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
12064037|NCT00089271|Drug|alvespimycin hydrochloride|Given IV
12064038|NCT00089271|Other|laboratory biomarker analysis|Correlative studies
12064039|NCT00089258|Biological|beta-glucan|
12064040|NCT00089258|Biological|monoclonal antibody 3F8|
12064041|NCT00089258|Biological|sargramostim|
12064042|NCT00089258|Drug|isotretinoin|
12064043|NCT00089245|Drug|Iodine I 131 MOAB 8H9|Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle.
12064044|NCT00089245|Drug|Iodine I 131 MOAB 8H9|The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle.
12064045|NCT00089219|Biological|IFA|vaccine adjuvant
12064046|NCT00089219|Biological|6MHP|melanoma helper peptides
12064047|NCT00089219|Biological|GM-CSF|vaccine adjuvant
12064048|NCT00089206|Biological|incomplete Freund's adjuvant|
12064049|NCT00089206|Biological|multi-epitope melanoma peptide vaccine|
12064050|NCT00089206|Biological|sargramostim|
12064051|NCT00089193|Biological|incomplete Freund's adjuvant|
12064052|NCT00089193|Biological|multi-epitope melanoma peptide vaccine|
12064053|NCT00089193|Biological|sargramostim|
12064054|NCT00089180|Drug|liposomal T4N5 lotion|Given topically
12064055|NCT00089180|Other|placebo|Given topically
12064526|NCT00004169|Drug|etoposide|
12064056|NCT00089180|Other|laboratory biomarker analysis|Correlative studies
12064057|NCT00089167|Biological|filgrastim|
12064058|NCT00089167|Drug|dexamethasone|
12064059|NCT00089167|Drug|melphalan|
12064060|NCT00089167|Drug|thalidomide|
12064061|NCT00089154|Biological|apolizumab|Given IV
12064062|NCT00089154|Other|laboratory biomarker analysis|Correlative studies
12064063|NCT00089154|Other|pharmacological study|Correlative studies
12064064|NCT00089141|Drug|mycophenolate mofetil|Given orally
12064065|NCT00089141|Drug|placebo|Given orally
12064066|NCT00089128|Drug|gemcitabine hydrochloride|
12064067|NCT00089128|Drug|irinotecan hydrochloride|
12064068|NCT00089115|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
12064069|NCT00089115|Biological|rituximab|
12064070|NCT00089115|Biological|sargramostim|
12064071|NCT00089102|Drug|gemcitabine hydrochloride|1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle
12064072|NCT00089102|Drug|irinotecan hydrochloride|100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
12064073|NCT00089089|Drug|decitabine|Given IV
12064074|NCT00089089|Other|pharmacological study|Correlative studies
12064075|NCT00089089|Other|laboratory biomarker analysis|Correlative studies
12064076|NCT00089076|Biological|ipilimumab|Given IV
12064077|NCT00089076|Other|laboratory biomarker analysis|Correlative studies
12064078|NCT00089063|Biological|tyrosinase peptide|Given SC
12064079|NCT00089063|Biological|gp100 antigen|Given SC
12064080|NCT00089063|Biological|MART-1 antigen|Given SC
12064081|NCT00089063|Biological|incomplete Freund's adjuvant|Given SC
12064082|NCT00089063|Drug|Montanide ISA 51 VG|Given SC
12064083|NCT00089063|Biological|sargramostim|Given SC
12064084|NCT00089063|Other|laboratory biomarker analysis|Correlative studies
12064085|NCT00089050|Drug|cyclosporine|
12064086|NCT00089050|Drug|gemtuzumab ozogamicin|
12064087|NCT00089037|Drug|methotrexate|
12064088|NCT00089037|Drug|sirolimus|
12064089|NCT00089037|Drug|tacrolimus|
12064090|NCT00089024|Drug|fluorouracil|2700 mg/m5 IV over 24 hr after gemcitabine weeks 1 & 2; Repeat one 3-week cycle starting day 22
12064091|NCT00089024|Drug|gemcitabine hydrochloride|750 (females) or 900 (males) mg/m5 IV over 30 min (day 2)weeks 1 & 2; Repeat one 3-week cycle starting day 22
12064092|NCT00089024|Drug|leucovorin calcium|20 mg/m5 PO (day 1) and 20 mg/m5 IV (day 2) weeks 1 and 2; Repeat one 3-week cycle starting day 22
12064093|NCT00089024|Drug|oxaliplatin|48 mg/m5 IV over 2 hr weeks 1, 2, 4, and 5
12064094|NCT00089024|Procedure|adjuvant therapy|"Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. Patients will then be followed at 3 month intervals with a history and physical exam, CT scan of the chest/abdomen/pelvis, and tumor markers.
~If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression provided the patient tolerates it and wishes to remain on therapy."
12064095|NCT00089024|Procedure|conventional surgery|Restaging with repeat imaging studies will be performed four weeks after completion of the chemo-radiation. If no contraindication for surgical resection is identified, resection will be performed six to eight weeks after completing chemoradiation. At the time of surgical resection, an extensive examination of the abdomen will be performed to exclude the presence of metastatic disease. All operations will be performed with curative intent with resection of all gross tumor (ie R0 [negative margins] or R1 [positive microscopic margins]). Resection of adjacent involved organs or vascular structures will be performed as clinically indicated.
12064096|NCT00089024|Procedure|neoadjuvant therapy|Eligible patients will receive an initial two cycles of chemotherapy with gemcitabine 750 (females) or 900 (males) mg/m5 over 30 minutes followed by a 24-hour infusion of fluorouracil 2700 mg/m5 on days 2 and 9 of a 21-day cycle . Calcium leucovorin 20 mg/m5 will be given orally on days 1 and 8 and by IV push on days 2 and 9 prior to the 5-FU. A window of -2 up to +7 days will be allowed to start planned cycles of therapy provided all other criteria to restart the new cycle has been met. Patients will require a central venous catheter (Port, Hickman or Groshong catheter) for the administration of 5-FU.
12064097|NCT00089024|Radiation|radiation therapy|A re-staging CT scan, which will be obtained as part of the radiation simulation, will be used to assess any possible response to the initial two cycles of chemotherapy. Unless the patient has developed evidence of metastatic disease, chemoradiation will proceed. Patients who required no treatment delays will commence chemoradiation on day 42. If a one-week delay is needed before cycle 2 of neo-adjuvant chemotherapy can be delivered, the patient will begin chemoradiation on day 49 provided treatment-related toxicity has resolved. If cycle 2 could not be given (2 or more week delay for resolution of treatment-related toxicity), then chemoradiation will begin once toxicity has resolved (may be earlier than day 42).
12064098|NCT00089011|Drug|fludarabine phosphate|Given IV
12064099|NCT00089011|Radiation|total-body irradiation|Undergo radiotherapy
12064100|NCT00089011|Drug|mycophenolate mofetil|Given IV or PO
12064101|NCT00089011|Drug|tacrolimus|Given IV or PO
12064102|NCT00089011|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplant
12064103|NCT00089011|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplant
12064104|NCT00089011|Other|laboratory biomarker analysis|Correlative studies
12064105|NCT00088998|Biological|bevacizumab|
12064106|NCT00088998|Drug|capecitabine|
12064107|NCT00088998|Drug|docetaxel|
12064108|NCT00088985|Biological|therapeutic autologous dendritic cells|10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
12064109|NCT00088985|Biological|trastuzumab|4 mg/kg intravenously, every 14 days
12064110|NCT00088985|Drug|vinorelbine ditartrate|Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
12064111|NCT00088972|Drug|celecoxib|Given orally
12064112|NCT00088972|Other|placebo|Given orally
12064113|NCT00088959|Drug|erlotinib hydrochloride|Given orally
12064114|NCT00088959|Drug|celecoxib|Given orally
12064115|NCT00088959|Other|laboratory biomarker analysis|Correlative studies
12064116|NCT00088946|Dietary Supplement|Polyphenon E|4-200mg capsules PO daily for 12 months
12064117|NCT00088946|Drug|erlotinib hydrochloride|100 mg PO daily for 12 months
12064118|NCT00088946|Other|Erlotinib placebo|identical to Erlotinib in look and appearance of dosing.
12064119|NCT00088946|Other|Polyphenon E|identical to Polyphenon E in look and appearance of dosing.
12064120|NCT00088933|Drug|recombinant fowlpox-CEA(6D)/TRICOM vaccine|Given intradermally
12064121|NCT00088933|Drug|recombinant vaccinia-CEA(6D)-TRICOM vaccine|Given intradermally
12064122|NCT00088933|Drug|docetaxel|Given IV
12064123|NCT00088933|Drug|sargramostim|Given subcutaneously
12064124|NCT00088907|Drug|docetaxel|Given IV
12064125|NCT00088907|Other|placebo|Given orally
12064126|NCT00088907|Drug|gefitinib|Given orally
12064127|NCT00088894|Drug|gemcitabine hydrochloride|Given IV
12064128|NCT00088894|Biological|bevacizumab|Given IV
12064129|NCT00088894|Other|placebo|Given IV
12064130|NCT00088894|Other|laboratory biomarker analysis|Correlative studies
12064131|NCT00088894|Other|pharmacogenomic studies|Correlative studies
12064132|NCT00088894|Other|pharmacological study|Correlative studies
12064133|NCT00088881|Biological|rituximab|Given IV
12064134|NCT00088881|Drug|prednisone|Given orally
12064135|NCT00088881|Drug|cyclophosphamide|Given IV
12064136|NCT00088881|Drug|doxorubicin|Given IV
12064137|NCT00088881|Drug|vincristine|Given IV
12064138|NCT00088881|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
12064139|NCT00088881|Radiation|radiation therapy|Undergo radiotherapy
12064140|NCT00088881|Procedure|positron emission tomography|Undergo PET scans
12064141|NCT00088868|Drug|alvespimycin hydrochloride|
12064142|NCT00088855|Drug|Bortezomib|Given IV
12064143|NCT00088855|Other|Laboratory Biomarker Analysis|Correlative studies
12064144|NCT00088855|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
12064145|NCT00088829|Drug|paclitaxel|subjects will receive paclitaxel neoadjuvantly
12064146|NCT00088829|Genetic|microarray analysis|subjects will have a biopsy to collect tissue for gene microarray analysis
12064147|NCT00088829|Procedure|biopsy|All subjects will have a biopsy to collect tissue
12064148|NCT00088829|Procedure|neoadjuvant therapy|paclitaxel is given neoadjuvantly
12064149|NCT00088829|Drug|Paclitaxel|All patients will receive paclitaxel neoadjuvantly
12064150|NCT00088816|Drug|cisplatin|
12064151|NCT00088816|Drug|tegafur-gimeracil-oteracil potassium|
12064152|NCT00088816|Procedure|adjuvant therapy|
12064153|NCT00088816|Procedure|conventional surgery|
12064154|NCT00088816|Procedure|neoadjuvant therapy|
12064155|NCT00088803|Genetic|molecular genetic technique|
12064156|NCT00088803|Genetic|polymerase chain reaction|
12064157|NCT00088803|Genetic|polymorphism analysis|
12064158|NCT00088790|Drug|AZD5438|
12064159|NCT00088777|Behavioral|Behavioral coping skills training plus physical therapy|10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education
12064160|NCT00088777|Behavioral|Stress management education plus physical therapy|10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education
12064161|NCT00088764|Behavioral|Coping skills training|8 sessions of pain and stress coping skills training
12064162|NCT00088764|Behavioral|Written emotional disclosure|4 sessions of writing about stress
12064163|NCT00088764|Behavioral|Arthritis education|8 sessions of learning about rheumatoid arthritis
12064164|NCT00088764|Behavioral|Health behavior writing|4 sessions of writing about various health behaviors
12064165|NCT00004193|Drug|ISIS 2503|
12064166|NCT00004187|Drug|capecitabine|
12064167|NCT00004187|Drug|oxaliplatin|
12064168|NCT00004186|Drug|carboplatin|
12064169|NCT00004186|Drug|etoposide|
12064170|NCT00004186|Drug|ifosfamide|
12064171|NCT00004186|Drug|topotecan hydrochloride|
12064172|NCT00004186|Radiation|radiation therapy|
12064173|NCT00004162|Biological|sargramostim|
12064174|NCT00004162|Drug|methotrexate|
12064175|NCT00004162|Drug|pegylated liposomal doxorubicin hydrochloride|
12064176|NCT00004162|Drug|vincristine sulfate|
12064177|NCT00004096|Drug|carboplatin|
12064178|NCT00004096|Drug|vinorelbine ditartrate|
12064179|NCT00004080|Biological|recombinant adenovirus-p53 SCH-58500|
12064180|NCT00004080|Procedure|conventional surgery|
12064181|NCT00004064|Biological|oregovomab|
12064182|NCT00004040|Biological|recombinant interferon alfa|
12064183|NCT00004040|Biological|rituximab|
12064184|NCT00004039|Biological|recombinant interferon alfa|
12064185|NCT00004039|Biological|rituximab|
12064186|NCT00004039|Drug|cyclophosphamide|
12064187|NCT00004039|Drug|doxorubicin hydrochloride|
12064188|NCT00004039|Drug|prednisone|
12064189|NCT00004039|Drug|vincristine sulfate|
12064190|NCT00003957|Biological|filgrastim|
12064191|NCT00003957|Biological|recombinant human stem cell factor|
12064192|NCT00003957|Drug|cyclophosphamide|
12064193|NCT00003957|Drug|cytarabine|
12064194|NCT00003957|Drug|etoposide|
12064195|NCT00003957|Drug|melphalan|
12064196|NCT00003957|Drug|mitoxantrone hydrochloride|
12064197|NCT00003957|Drug|paclitaxel|
12064198|NCT00003957|Procedure|peripheral blood stem cell transplantation|
12064199|NCT00003892|Drug|ISIS 5132|4mg/kg/day IV for 21 days every 4 weeks.
12064200|NCT00003828|Drug|vinorelbine|
12064201|NCT00003821|Drug|aminopterin|
12064202|NCT00003810|Drug|docetaxel|
12064203|NCT00003810|Drug|gemcitabine hydrochloride|
12064204|NCT00003798|Drug|motexafin gadolinium|
12064205|NCT00003798|Radiation|radiation therapy|
12064206|NCT00003786|Drug|irofulven|
12064207|NCT00003784|Drug|CHOP regimen|
12064208|NCT00003784|Drug|cyclophosphamide|
12064209|NCT00003784|Drug|doxorubicin hydrochloride|
12064210|NCT00003784|Drug|prednisone|
12064211|NCT00003784|Drug|vincristine sulfate|
12064212|NCT00003784|Radiation|tositumomab and iodine I 131 tositumomab|
12064213|NCT00003760|Drug|irofulven|Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for up to 1 year after therapy initiation.
12064214|NCT00003708|Drug|temozolomide|Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.
12064215|NCT00003681|Biological|epoetin alfa|
12064216|NCT00003681|Drug|amifostine trihydrate|
12064217|NCT00003663|Biological|rituximab|
12064218|NCT00003663|Drug|dexamethasone|
12064219|NCT00003662|Biological|anti-thymocyte globulin|
12064220|NCT00003662|Drug|busulfan|
12064221|NCT00003662|Drug|cyclophosphamide|
12064222|NCT00003662|Drug|cyclosporine|
12064223|NCT00003662|Drug|melphalan|
12064224|NCT00003662|Drug|methylprednisolone|
12064225|NCT00003662|Procedure|umbilical cord blood transplantation|
12064226|NCT00003662|Radiation|radiation therapy|
12064227|NCT00003661|Biological|anti-thymocyte globulin|
12064228|NCT00003661|Drug|busulfan|
12064229|NCT00003661|Drug|cyclosporine|
12064230|NCT00003661|Drug|melphalan|
12064231|NCT00003661|Drug|methylprednisolone|
12064232|NCT00003661|Procedure|umbilical cord blood transplantation|
12064233|NCT00003661|Radiation|radiation therapy|
12064234|NCT00003605|Biological|rituximab|
12064235|NCT00003605|Drug|cyclophosphamide|
12064236|NCT00003542|Biological|pegylated interferon alfa|
12064237|NCT00003539|Biological|trastuzumab|
12064238|NCT00003539|Drug|paclitaxel|
12064239|NCT00003431|Biological|recombinant flt3 ligand|
12064240|NCT00003424|Drug|tamoxifen citrate|
12064241|NCT00088673|Drug|3APS|
12064242|NCT00003416|Biological|filgrastim|
12064243|NCT00003416|Biological|recombinant interferon alfa|
12064244|NCT00003416|Drug|dexamethasone|
12064245|NCT00003416|Drug|melphalan|
12064246|NCT00003416|Procedure|peripheral blood stem cell transplantation|
12064247|NCT00003415|Drug|amifostine trihydrate|
12064248|NCT00003415|Drug|topotecan hydrochloride|
12064249|NCT00003413|Biological|filgrastim|
12064250|NCT00003413|Drug|carmustine|
12064251|NCT00003413|Drug|cisplatin|
12064252|NCT00003413|Drug|melphalan|
12064253|NCT00003413|Drug|paclitaxel|
12064254|NCT00003413|Procedure|peripheral blood stem cell transplantation|
12064255|NCT00003413|Procedure|surgical procedure|
12064256|NCT00088738|Drug|[18F] SPA-RQ|
12064257|NCT00088699|Drug|Ketamine|
12064258|NCT00088699|Drug|Placebo|
12064259|NCT00088686|Drug|Capsaicin (Intramucosal Injection)|
12064260|NCT00088660|Biological|PANVAC™-VF|
12064261|NCT00088647|Drug|MST-997|
12064262|NCT00088634|Drug|Lurasidone|80 mg AM dosing once daily
12064263|NCT00088634|Drug|Placebo|Matching Placebo to 40mg lurasidone tablets
12064264|NCT00088621|Drug|Lurasidone 80mg tablet|
12064265|NCT00088608|Drug|SOM230 s.c.|
12064266|NCT00088595|Drug|Pasireotide (SOM230)|Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred.
12064267|NCT00088582|Drug|Pasireotide (SOM230), Octreotide (Sandostatin)|
12064268|NCT00003358|Drug|chemotherapy|
12064269|NCT00003358|Drug|cisplatin|
12064270|NCT00003358|Drug|gemcitabine hydrochloride|
12064271|NCT00003305|Drug|aminopterin|
12064272|NCT00003305|Drug|leucovorin calcium|
12064273|NCT00003259|Drug|vinorelbine tartrate|
12064274|NCT00003256|Drug|alvocidib|
12064275|NCT00003214|Drug|carboplatin|
12064276|NCT00003214|Drug|cisplatin|
12064277|NCT00003214|Drug|cyclophosphamide|
12064278|NCT00003214|Drug|doxorubicin hydrochloride|
12064279|NCT00003214|Drug|in vitro sensitivity-directed chemotherapy|
12064280|NCT00003214|Drug|paclitaxel|
12064281|NCT00003213|Drug|dexamethasone|4 mg Dexamethasone in the morning
12064282|NCT00003213|Drug|granisetron hydrochloride|1 mg Granisetron in the morning
12064283|NCT00003213|Drug|metoclopramide hydrochloride|20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening)
12064284|NCT00003182|Drug|cisplatin|
12064285|NCT00003182|Drug|gemcitabine hydrochloride|
12064286|NCT00003158|Drug|carboplatin|
12064287|NCT00003158|Drug|etoposide|
12064288|NCT00003158|Drug|paclitaxel|
12064289|NCT00003158|Radiation|radiation therapy|
12064290|NCT00003152|Biological|filgrastim|
12064291|NCT00003152|Biological|recombinant interferon alfa|
12064292|NCT00003152|Drug|cyclophosphamide|
12064293|NCT00003152|Drug|prednisone|
12064294|NCT00003152|Drug|vincristine sulfate|
12064295|NCT00003152|Procedure|autologous bone marrow transplantation|
12064296|NCT00003152|Procedure|bone marrow ablation with stem cell support|
12064297|NCT00003152|Procedure|peripheral blood stem cell transplantation|
12064298|NCT00003152|Radiation|radiation therapy|
12064299|NCT00003097|Other|preventative dietary intervention|
12064300|NCT00003090|Biological|aldesleukin|
12064301|NCT00003087|Drug|cisplatin|
12064302|NCT00003087|Drug|paclitaxel|
12064303|NCT00003087|Procedure|surgical procedure|
12064304|NCT00003087|Radiation|radiation therapy|
12064305|NCT00003068|Drug|amifostine trihydrate|
12064306|NCT00003068|Drug|cyclophosphamide|
12064307|NCT00003068|Drug|mitoxantrone hydrochloride|
12064308|NCT00003068|Drug|thiotepa|
12064309|NCT00003068|Procedure|peripheral blood stem cell transplantation|
12064310|NCT00088569|Drug|0-15 Water|
12064311|NCT00088556|Drug|TLK286|Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
12064312|NCT00088556|Drug|carboplatin|AUC 6 mg/mL/min Once every 3 weeks
12064313|NCT00088556|Drug|paclitaxel|200 mg/m² Once every 3 weeks
12064314|NCT00088543|Biological|Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]|total dose 4.5 mg/kg
12064315|NCT00088543|Biological|Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]|total dose 8.5 mg/kg
12064316|NCT00003055|Drug|cisplatin|
12064317|NCT00003055|Drug|irinotecan hydrochloride|
12064318|NCT00003050|Drug|cyclophosphamide|
12064319|NCT00003050|Drug|doxorubicin hydrochloride|
12064320|NCT00003050|Drug|paclitaxel|
12064321|NCT00003050|Drug|tamoxifen citrate|
12064322|NCT00003050|Procedure|surgical procedure|
12064323|NCT00003050|Radiation|radiation therapy|
12064324|NCT00003002|Biological|HER-2/neu peptide vaccine|
12064325|NCT00003002|Biological|sargramostim|
12064326|NCT00003000|Drug|fentanyl citrate|
12064327|NCT00003000|Drug|morphine sulfate|
12064328|NCT00002984|Drug|cisplatin|Cisplatin will be given at a dose of 100 mg/m2 at a concentration of 1 mg/ml over one hour on Day 1 and 29 for a total of 2 courses
12064329|NCT00002984|Drug|fluorouracil|5-FU will be given at 500 mg/m2 in 1 liter D5 1/2 by continuous infusion every 12 hours for a total of 8 doses (Total 1.0 g/m2/day X 4 days) on Days 1-4 and 29-32 for a total of 2 courses
12064330|NCT00002984|Drug|paclitaxel|30 mg/m2 - 45 mg/m2 given weekly. The dose each subject receives will depend on when they enter the study
12064331|NCT00002984|Procedure|surgical procedure|Surgical resection should take place approximately 4 weeks following completion of the chemotherapy.
12064332|NCT00002984|Radiation|radiation therapy|The dose of radiation to the tumor and nodal area will be 4500 cGy given as 180 cGy fractions daily, Monday through Friday, for 5 weeks
12064333|NCT00002921|Drug|suramin|
12064334|NCT00002921|Drug|therapeutic hydrocortisone|
12064335|NCT00002833|Biological|Filgrastim|Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
12064336|NCT00002833|Drug|Cladribine|Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
12064337|NCT00002833|Drug|Cyclosporine|For GVHD prophylaxis, cyclosporine via continuous IV infusion. Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion. Then dose tapered 10% weekly until discontinued.
12064338|NCT00002833|Drug|Cytarabine (Ara-C)|Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
12064339|NCT00002833|Drug|Fludarabine Phosphate|IV over 30 minutes daily on days -6, -5, -4 and -3.
12064340|NCT00002833|Drug|Idarubicin|IV Days -6, -5 and -4.
12064341|NCT00002833|Drug|Methylprednisolone|Begins 5 days after infusion and is gradually tapered.
12064342|NCT00002833|Procedure|Peripheral Blood Stem Cell Transplantation|Cell infusion Day 0.
12064343|NCT00088530|Drug|pixantrone, cyclophosphamide, vincristine, rituximab, prednisone|Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
12064344|NCT00088530|Drug|Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab|Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
12064345|NCT00002832|Biological|Filgrastim|Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection then daily starting 1 day after PBSC infusion until blood counts recover.
12064346|NCT00002832|Drug|Cyclosporine|IV daily on day -2, then orally once dose is tolerable, dose may be escalated.
12064347|NCT00002832|Drug|Decitabine|IV for 6 hours every 12 hr for 5 days.
12064348|NCT00002832|Procedure|Allogeneic Bone Marrow Transplantation|Stem cell infusion on Day 0.
12064349|NCT00002832|Procedure|Peripheral Blood Stem Cell Transplantation|Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine.
12064350|NCT00002831|Biological|Filgrastim|Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.
12064351|NCT00002831|Drug|Busulfan|Administered orally every 6 hours on consecutive days -6 through -4.
12064352|NCT00002831|Drug|Cyclophosphamide|Given intravenously (IV) over 1 hour on consecutive days -3 and -2.
12064353|NCT00002831|Drug|Cyclosporine|Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.
12064354|NCT00002831|Drug|Decitabine (DAC)|IV over 4 hours on days -8 and -7.
12064355|NCT00002831|Drug|Methotrexate|Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.
12064356|NCT00002831|Drug|Methylprednisolone|Given according to clinical grade of GVHD procedures.
12064357|NCT00002831|Drug|Tacrolimus|IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.
12064358|NCT00002831|Procedure|Allogeneic Bone Marrow Transplantation|Infusion of stem cells on Day 0.
12064359|NCT00002831|Procedure|Peripheral Blood Stem Cell Transplantation|Stem cell infusion on Day 0.
12064360|NCT00002824|Biological|gene therapy|
12064361|NCT00002824|Drug|chemotherapy|
12064362|NCT00002824|Drug|ganciclovir|
12064363|NCT00002824|Procedure|conventional surgery|
12064364|NCT00002784|Biological|filgrastim|Filgrastim 10 mg/kg/d sc for 6 days after randomization.
12064365|NCT00002784|Drug|CMF regimen|Cyclophosphamide 100 mg/m2 orally days 1 - 14, methotrexate 40 mg/m2 iv days 1 and 8, 5-fluorouracil 600 mg/m2 iv days 1 and 8. Repeat every 28 days.
12064366|NCT00002784|Drug|cyclophosphamide|For high-dose EC arm: cyclophosphamide 4 gm/m2 iv as 4 divided doses. For standard chemotherapy arm: cyclophosphamide 600 mg/m2 iv day 1 of 21-day EC cycles, and cyclophosphamide 100 mg/m2 orally on days 1-14 of 28-day CMF cycles.
12064367|NCT00002784|Drug|doxorubicin hydrochloride|Doxorubicin 60 mg/m2 iv on day 1 of 21-day cycles of AC.
12064368|NCT00002784|Drug|epirubicin hydrochloride|Epirubicin 90 mg/m2 iv on day 1 of 21-day cycles of EC.
12064369|NCT00002784|Drug|fluorouracil|5-fluorouracil 600 mg/m2 iv days 1 and 8 of 28-day cycles of CMF.
12064370|NCT00002784|Drug|mesna|MESNA (7.2 gm/m2) on days 2 and 3 of 21-day cycles of dose-intensive EC.
12064371|NCT00002784|Drug|methotrexate|Methotrexate 40 mg/m2 iv on days 1 and 8 of 28-day cycles of CMF.
12064372|NCT00002784|Drug|tamoxifen citrate|Tamoxifen 20mg daily for 5 years or until relapse.
12064373|NCT00002784|Procedure|peripheral blood stem cell transplantation|Peripheral blood progenitor cells (PBPC) infusion on day 5 of each 21-day cycle of dose-intensive EC.
12064374|NCT00002784|Radiation|low-LET electron therapy|Radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.
12064375|NCT00002784|Radiation|low-LET photon therapy|radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.
12064376|NCT00002779|Drug|fludarabine phosphate|
12064377|NCT00002779|Drug|octreotide acetate|
12064378|NCT00002754|Biological|monoclonal antibody Me1-14 F(ab')2|
12064379|NCT00002753|Radiation|iodine I 131 monoclonal antibody 81C6|
12064380|NCT00002688|Drug|cyclosporine|
12064381|NCT00002688|Drug|etoposide|
12064382|NCT00002688|Drug|mitoxantrone hydrochloride|
12064383|NCT00002675|Biological|filgrastim|
12064384|NCT00002675|Drug|carboplatin|
12064385|NCT00002675|Drug|cisplatin|
12064386|NCT00002675|Drug|cyclophosphamide|
12064387|NCT00002675|Drug|etoposide|
12064388|NCT00002675|Drug|mesna|
12064389|NCT00002675|Drug|vincristine sulfate|
12064390|NCT00002665|Drug|asparaginase|10,000 units/d IV or IM 15 - 24
12064391|NCT00002665|Drug|cyclophosphamide|con: 650 mg/m2 IV 1, 15, 29 maint: 650 mg/m2 IV 1
12064392|NCT00002665|Drug|cytarabine|cons: 75 mg/m2/d IV Push 2 - 5, 9 - 12, 6 - 19, 23 - 26
12064393|NCT00002665|Drug|daunorubicin hydrochloride|ind: 60 mg/m2 IV 22 and 23
12064394|NCT00002665|Drug|dexamethasone|main: 10 mg/m2/day PO 1 - 28
12064395|NCT00002665|Drug|doxorubicin hydrochloride|main: 25 mg/m2 IV 1, 8, 15, and 22
12064396|NCT00002665|Drug|etoposide|60 mg/kg based on ideal body weight day -3
12064397|NCT00002665|Drug|leucovorin calcium|5 mg q 6 hours for 4 doses, PO 1, 3, 8, 11 after each methotrexate if WBC < 3,000 /μl
12064398|NCT00002665|Drug|mercaptopurine|con: 60 mg/m2 PO 1 - 28
12064399|NCT00002665|Drug|methotrexate|10 mg/m2 IT or IV, d 2, 9, 16, and 23; Maximum 15 mg/admin
12064400|NCT00002665|Drug|prednisone|"ind: 60 mg/m2/d PO 1 - 21*, 22 - 28 Patients will receive full dose through day 8 and then tapered to zero between Day 29 and 42.
~ind2: 60 mg/m2/d PO through day 42"
12064401|NCT00002665|Drug|thioguanine|main: 60 mg/m2/day PO 1 - 14
12064402|NCT00002665|Drug|vincristine sulfate|ind: 1.4 mg/m2 2 mg max, IV 1, 8, 15, and 22 ind2: 1.4 mg/m2 2 mg max IV 29 and 36 main: 1.5 mg/m2 2 mg max, IV 1, 8, 15, and 22
12064403|NCT00002665|Procedure|allogeneic bone marrow transplantation|day 0
12064404|NCT00002665|Radiation|radiation therapy|day -7 through day -4 total dose of radiation is 1,320 cGy.
12064405|NCT00002630|Biological|filgrastim|
12064406|NCT00002630|Drug|cyclophosphamide|
12064407|NCT00002630|Drug|melphalan|
12064408|NCT00002630|Procedure|peripheral blood stem cell transplantation|
12064409|NCT00002630|Radiation|low-LET cobalt-60 gamma ray therapy|
12064410|NCT00002630|Radiation|low-LET photon therapy|
12064411|NCT00002627|Biological|filgrastim|
12064412|NCT00002627|Drug|carboplatin|
12064413|NCT00002627|Drug|cyclophosphamide|
12064414|NCT00002627|Drug|mesna|
12064415|NCT00002627|Drug|paclitaxel|
12064416|NCT00002627|Procedure|peripheral blood stem cell transplantation|
12064417|NCT00002618|Biological|filgrastim|
12064418|NCT00002618|Drug|cytarabine|
12064419|NCT00002618|Drug|doxorubicin hydrochloride|
12064420|NCT00002618|Drug|leucovorin calcium|
12064421|NCT00002618|Drug|mercaptopurine|
12064422|NCT00002618|Drug|methotrexate|
12064423|NCT00002618|Drug|prednisone|
12064424|NCT00002618|Drug|vincristine sulfate|
12064425|NCT00002618|Radiation|low-LET cobalt-60 gamma ray therapy|
12064426|NCT00002618|Radiation|low-LET electron therapy|
12064427|NCT00002618|Radiation|low-LET photon therapy|
12064428|NCT00002604|Drug|O6-benzylguanine|Patients receive BG IV over 1 hour during week 1, and then BG IV over 1 hour during week 3. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
12064429|NCT00002604|Drug|carmustine|After one hour of receiving BG patients receive BCNU IV over 1 hour during week 3. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
12064430|NCT00002604|Drug|chemosensitization/potentiation therapy|
12064431|NCT00002588|Drug|etoposide|
12064432|NCT00002588|Drug|topotecan hydrochloride|
12064433|NCT00002572|Biological|aldesleukin|
12064434|NCT00002572|Biological|muromonab-CD3|
12064435|NCT00002572|Biological|therapeutic tumor infiltrating lymphocytes|
12064436|NCT00002572|Procedure|conventional surgery|
12064437|NCT00002542|Drug|CMF regimen|
12064438|NCT00002542|Drug|cyclophosphamide|
12064439|NCT00002542|Drug|doxorubicin hydrochloride|
12064850|NCT00003589|Drug|cisplatin|
12064440|NCT00002542|Drug|epirubicin hydrochloride|
12064441|NCT00002542|Drug|fluorouracil|
12064442|NCT00002542|Drug|methotrexate|
12064443|NCT00002542|Drug|tamoxifen citrate|
12064444|NCT00002542|Radiation|radiation therapy|
12064445|NCT00002535|Biological|aldesleukin|
12064446|NCT00002535|Biological|lymphokine-activated killer cells|
12064447|NCT00002535|Biological|therapeutic tumor infiltrating lymphocytes|
12064448|NCT00002535|Drug|cyclophosphamide|
12064449|NCT00002535|Drug|indomethacin|
12064450|NCT00002529|Drug|cyclophosphamide|cyclophosphamide 600 mg/m2 i.v. day 1) every 21 days
12064451|NCT00002529|Drug|doxorubicin hydrochloride|doxorubicin 60 mg/m2 i.v. day 1) every 21 days, intravenous.
12064452|NCT00002529|Drug|epirubicin hydrochloride|epirubicin 90 mg/m2 i.v. day 1) every 21 days, intravenous.
12064453|NCT00002529|Drug|tamoxifen citrate|Tamoxifen 20 mg daily.
12064454|NCT00002529|Drug|toremifene|Toremifene 60 mg daily.
12064455|NCT00088517|Drug|[11C]NNC-112|
12064456|NCT00088504|Drug|Merimepodib|
12064457|NCT00088504|Drug|PEG-Interferon-alpha 2a (Pegasys®)|
12064458|NCT00088504|Drug|Ribavirin (Copegus®)|
12064459|NCT00088491|Drug|Intramuscular Olanzapine Depot|
12064460|NCT00088491|Drug|Oral Olanzapine|
12064461|NCT00088478|Drug|Intramuscular Olanzapine Depot|
12064462|NCT00088478|Drug|Placebo|
12064463|NCT00088465|Drug|Intramuscular olanzapine depot|45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
12064464|NCT00088452|Drug|Ethosuximide|Ethosuximide is a common treatment for childhood absence epilepsy.
12064465|NCT00088452|Drug|Lamotrigine|Lamotrigine is a common treatment for childhood absence epilepsy.
12064466|NCT00088452|Drug|Valproic acid|Valproic acid is a common treatment for childhood absence epilepsy.
12064467|NCT00088413|Biological|PANVAC-V|Patients receive 2 x 10(8) pfu PANVAC-V (vaccinia) subcutaneously on Day 1.
12064468|NCT00088413|Biological|PANVAC-F|Patients receive 1 x 10(9) pfu PANVAC-F (fowlpox) or about days 15, 29, and 43 then every month for 12 doses then every 3 months until disease progression or toxicity.
12064469|NCT00088413|Drug|Sargramostim (GM-CSF, Leukine)|100g sargramostim will be given subcutaneously at the site of the vaccination on each vaccination day and for three consecutive days thereafter.
12064470|NCT00088400|Drug|TransMID|
12064471|NCT00088387|Drug|Divalproex|
12064472|NCT00088387|Drug|Lithium|
12064473|NCT00088374|Drug|17 allylamino-17-demethoxygeldanamycin|17 allylamino-17-demethoxygeldanamycin (17 AAG) given intravenously at a dose of 300 mg/m2 on days 1,8 and 15 of 28 day cycles.
12064474|NCT00088374|Drug|18 FDG (Fludeoxyglucose 18F)|18FDG PET performed at baseline and 12 weeks after treatment. At each timepoint participants can receive 250mCi 0-15 water and 15 mCi F18-FDG.
12064475|NCT00088374|Drug|[15-O] H2O|[15-0] H20 performed at baseline and 12 weeks after treatment. At each time point participants can receive 250mCi 0-15 water and 15 mCi F18-FDG. The water scans were done as several intravenous injections for several scans but not over a total of 250 mCi.
12064476|NCT00088374|Drug|EPL diluent|17AAG is formulated with this diluent. Supplied in a 50 mL flint vial containing 48 mL of 2% egg phospholipids, and 5% dextrose in Water for Injection, USP. Patients with a history of serious allergic reactions to eggs should not receive this agent.
12064477|NCT00088309|Procedure|Eye exam|
12064478|NCT00088309|Procedure|Oral exam|
12064479|NCT00088309|Procedure|CT scan|
12064480|NCT00088309|Procedure|Neuropsychological testing|
12064481|NCT00088309|Procedure|Electrocardiogram|
12064482|NCT00088309|Procedure|Echocardiogram|
12064483|NCT00088296|Procedure|Blood Draw|
12064484|NCT00088283|Drug|pegaptanib sodium|
12064485|NCT00088270|Drug|OSI-7904L|
12064486|NCT00088270|Drug|5-Fluorouracil/Leucovorin|
12064487|NCT00005884|Drug|eflornithine|
12064488|NCT00005852|Biological|anti-thymocyte globulin|
12064489|NCT00005852|Biological|filgrastim|
12064490|NCT00005852|Biological|muromonab-CD3|
12064491|NCT00005852|Drug|cyclophosphamide|
12064492|NCT00005852|Drug|cyclosporine|
12064493|NCT00005852|Drug|methylprednisolone|
12064494|NCT00005852|Procedure|allogeneic bone marrow transplantation|
12064495|NCT00005805|Dietary Supplement|St. John's wort|
12064496|NCT00005633|Biological|OVA BiP peptide|
12064497|NCT00005633|Biological|gp209-2M antigen|
12064498|NCT00005633|Biological|recombinant 70-kD heat-shock protein|
12064499|NCT00005633|Biological|tyrosinase peptide|
12064500|NCT00005624|Drug|CI-994|CI-994 as outlined in treatment arm.
12064501|NCT00005614|Drug|Gemcitabine hydrochloride|Gemcitabine via IV
12064502|NCT00005611|Drug|BMS-188797|
12064503|NCT00004902|Drug|tocladesine|
12064504|NCT00004901|Drug|ethynyluracil|
12064505|NCT00004901|Drug|fluorouracil|
12064506|NCT00004901|Drug|hydroxyurea|
12064507|NCT00004901|Radiation|radiation therapy|
12064508|NCT00004897|Biological|recombinant interferon alfa|
12064509|NCT00004897|Drug|cisplatin|
12064510|NCT00004897|Drug|fluorouracil|
12064511|NCT00004897|Drug|hydroxyurea|
12064512|NCT00004897|Drug|leucovorin calcium|
12064513|NCT00004897|Procedure|conventional surgery|
12064514|NCT00004897|Radiation|radiation therapy|
12064515|NCT00004875|Drug|enoxaparin|
12064516|NCT00004875|Drug|heparin|
12064517|NCT00004265|Drug|paclitaxel|
12064518|NCT00004264|Drug|amifostine trihydrate|
12064519|NCT00004264|Drug|cisplatin|
12064520|NCT00004264|Drug|docetaxel|
12064521|NCT00004263|Drug|7-hydroxystaurosporine (UCN-01)|20 mg/m2 IV over 24 hours on days 2-4 of course 1 and over 36 hours beginning on day 2 of subsequent courses. Treatment repeats every 4 weeks for a maximum of 4 courses.
12064522|NCT00004263|Drug|Cytarabine (Ara-C)|Starting dose 1 g/m2 IV over 24 hours on days 1-4 of each course. Treatment repeats every 4 weeks for a maximum of 4 courses.
12064523|NCT00004258|Drug|cilengitide|dose escalation of cilengitide
12064527|NCT00004169|Procedure|peripheral blood stem cell transplantation|
12064528|NCT00004169|Radiation|radiation therapy|
12064529|NCT00004159|Drug|gemcitabine hydrochloride|
12064530|NCT00004159|Drug|paclitaxel|
12064531|NCT00003942|Biological|RevM10 gene|
12064532|NCT00003942|Biological|RevM10/polAS gene|
12064533|NCT00003942|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12064534|NCT00003942|Procedure|peripheral blood stem cell transplantation|
12064535|NCT00003936|Drug|bryostatin 1|
12064536|NCT00003929|Biological|filgrastim|Filgrastim (G-CSF) is administered subcutaneously daily on days 12-21 and days 33-42, until absolute neutrophil counts recover. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
12064537|NCT00003929|Drug|lomustine|Oral lomustine on day 1. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
12064538|NCT00003929|Drug|procarbazine hydrochloride|Oral procarbazine on days 1-10 and days 22-31. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
12064539|NCT00003929|Radiation|radiation therapy|Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy.
12064540|NCT00002506|Biological|recombinant interferon alfa|
12064541|NCT00002506|Drug|isotretinoin|
12064542|NCT00002504|Biological|aldesleukin|
12064543|NCT00002504|Biological|recombinant interferon alfa|
12064544|NCT00002462|Biological|bleomycin sulfate|
12064545|NCT00002462|Drug|doxorubicin hydrochloride|
12064546|NCT00002462|Drug|mechlorethamine hydrochloride|
12064547|NCT00002462|Drug|prednisone|
12064548|NCT00002462|Drug|procarbazine hydrochloride|
12064549|NCT00002462|Drug|vinblastine sulfate|
12064550|NCT00002462|Drug|vincristine sulfate|
12064551|NCT00002462|Radiation|low-LET cobalt-60 gamma ray therapy|
12064552|NCT00002462|Radiation|low-LET photon therapy|
12064553|NCT00002462|Radiation|radiation therapy|
12064554|NCT00088231|Drug|Imatinib Mesylate (Gleevec)|"600 mg by mouth every day (for AML, CML-BP) for a 28 day cycle.
~400 mg by mouth every day (for AMM) for a 28 day cycle."
12064555|NCT00088231|Drug|PTK 787 (vatalanib)|"For 1 week prior to receipt of the study combination regimen, all patients will receive single agent PTK 787 at the dose specified for that dose level of the study combination regimen to allow stabilization of PTK 787 levels.
~Starting dose: 250 mg by mouth every day for a 28 day cycle."
12064556|NCT00088218|Drug|Clofarabine|1-hour IV infusion 30 mg/m^2 daily times 5 days (Days 1-5)
12064557|NCT00088218|Drug|Ara-C|20 mg/m^2 subcutaneously daily times 14 days (Days 1-14). On Days 1 to 5 of each course, clofarabine will precede injection of ara-C by approximately 4 hours (+/- 1 hour).
12064558|NCT00088205|Drug|enzastaurin|500 milligrams (mg), oral, daily, up to six 28-day cycles
12064559|NCT00088179|Drug|pexelizumab in conjunction with CABG|
12064560|NCT00087997|Drug|STA-4783|
12064561|NCT00088192|Drug|pegaptanib sodium|
12064562|NCT00088166|Drug|hCRF|hCRF ; open-label dexamethasone that the patient is currently taking
12064563|NCT00088166|Drug|placebo hCRF|placebo hCRF 2mg/day and open-label dexamethasone that they are taking
12064564|NCT00003884|Drug|zoledronic acid|
12064565|NCT00003884|Procedure|quality-of-life assessment|
12064566|NCT00003812|Biological|filgrastim|
12064567|NCT00003812|Drug|carboplatin|
12064568|NCT00003812|Drug|etoposide|
12064569|NCT00003812|Drug|paclitaxel|
12064570|NCT00003812|Drug|topotecan hydrochloride|
12064571|NCT00003812|Radiation|radiation therapy|
12064572|NCT00003808|Drug|theophylline|
12064573|NCT00003781|Drug|docetaxel|
12064574|NCT00003781|Procedure|pain therapy|
12064575|NCT00003781|Procedure|quality-of-life assessment|
12064576|NCT00003763|Procedure|radionuclide imaging|
12064577|NCT00003763|Radiation|indium In 111 folic acid|
12064578|NCT00003748|Drug|irinotecan hydrochloride|One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks.
12064579|NCT00003725|Drug|valrubicin|
12064580|NCT00003725|Procedure|conventional surgery|
12064581|NCT00003677|Drug|Dolastatin 10|IV bolus once every 21 days.
12064582|NCT00003675|Drug|topotecan hydrochloride|1.2 mg/sq m twice a day for 5 days (Arm I) and once a day for 10 days (Arm II)
12064583|NCT00003610|Dietary Supplement|capsaicin|
12064584|NCT00003610|Other|placebo|
12064585|NCT00003610|Radiation|radiation therapy|
12064586|NCT00003585|Biological|aldesleukin|
12064587|NCT00003585|Biological|recombinant interferon alfa|
12064588|NCT00003585|Drug|fluorouracil|
12064589|NCT00003585|Drug|isotretinoin|
12064590|NCT00003585|Procedure|surgical procedure|
12064591|NCT00003557|Drug|dolastatin 10|
12064592|NCT00003392|Biological|filgrastim|10 mcg/kg/d, day 2 through last day of leukapheresis
12064593|NCT00003392|Drug|carboplatin|18 AUC IV, approximately days 21, 42
12064594|NCT00003392|Drug|cyclophosphamide|4 gm/m2 IV, day 1
12064595|NCT00003392|Drug|melphalan|140 mg/m2 IV , approximately day 63
12064596|NCT00003392|Drug|paclitaxel|170 mg/m2 IV day 1
12064597|NCT00003392|Procedure|bone marrow ablation with stem cell support|
12064598|NCT00003392|Procedure|peripheral blood stem cell transplantation|
12064599|NCT00003391|Biological|monoclonal antibody muJ591|
12064600|NCT00003267|Procedure|infection prophylaxis and management|
12064601|NCT00003267|Procedure|management of therapy complications|
12064602|NCT00003267|Procedure|surgical procedure|
12064603|NCT00088153|Drug|Physiologic Estrogen/progesterone|Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month
12064604|NCT00088153|Other|Placebo|Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month
12064605|NCT00088140|Drug|IDN-6556|
12064606|NCT00088140|Drug|Placebo|
12064607|NCT00088114|Drug|STA-4783/paclitaxel|
12064608|NCT00088101|Drug|STA-5312|
12064609|NCT00088088|Drug|Paclitaxel|
12064610|NCT00088088|Drug|Carboplatin|
12064611|NCT00088088|Drug|STA 4783|
12064612|NCT00088075|Drug|Risperidone|
12064613|NCT00088062|Drug|STA-5326|
12064614|NCT00088049|Drug|Olanzapine|
12064615|NCT00088049|Drug|Aripiprazole|
12064616|NCT00088036|Drug|Olanzapine|
12064617|NCT00003238|Drug|perillyl alcohol|
12064618|NCT00003225|Drug|amifostine trihydrate|Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.
12064619|NCT00003225|Drug|irinotecan hydrochloride|"10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV.
~Administered every 14 days for 3 cycles"
12064620|NCT00088023|Drug|PT-523 for Injection|
12064621|NCT00088010|Drug|Arzoxifene|20mg, oral, tablet, once a day for 36 months
12064622|NCT00088010|Drug|Placebo|oral, tablet, once a day for 36 months
12064623|NCT00087984|Biological|MB-002|Dendritic Cell Immunotherapy
12064624|NCT00087958|Drug|XRP9881|
12064625|NCT00087945|Drug|Abacavir sulfate|
12064626|NCT00087945|Drug|Abacavir sulfate, lamivudine, and zidovudine|
12064627|NCT00087880|Drug|Bupropion and NRT|All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
12064628|NCT00087867|Drug|SCIO-469|two 30-mg capsules three times daily
12064629|NCT00087867|Drug|SCIO-469 and bortezomib|In addition to SCIO-469, patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest period
12064630|NCT00005996|Drug|cisplatin|
12064631|NCT00005996|Drug|gemcitabine hydrochloride|
12064632|NCT00005996|Drug|semaxanib|
12064633|NCT00005806|Drug|carboplatin|
12064634|NCT00005806|Drug|gefitinib|
12064635|NCT00005806|Drug|paclitaxel|
12064636|NCT00005632|Biological|MUC1-KLH vaccine/QS21|
12064637|NCT00005619|Genetic|polymerase chain reaction|
12064638|NCT00005619|Other|flow cytometry|
12064639|NCT00005619|Other|immunohistochemistry staining method|
12064640|NCT00005042|Drug|semaxanib|
12064641|NCT00005029|Drug|topotecan hydrochloride|
12064642|NCT00004199|Drug|cisplatin|
12064643|NCT00004199|Drug|gemcitabine hydrochloride|
12064644|NCT00004199|Drug|prinomastat|
12064645|NCT00004164|Biological|filgrastim|
12064646|NCT00004164|Drug|cisplatin|
12064647|NCT00004164|Drug|docetaxel|
12064648|NCT00004164|Drug|fluorouracil|
12064649|NCT00004164|Drug|leucovorin calcium|
12064650|NCT00004164|Radiation|radiation therapy|
12064651|NCT00004160|Drug|cisplatin|
12064652|NCT00004160|Drug|gemcitabine hydrochloride|
12064653|NCT00004160|Drug|paclitaxel|
12064654|NCT00004160|Radiation|radiation therapy|
12064655|NCT00004158|Drug|melphalan|
12064656|NCT00004158|Procedure|peripheral blood stem cell transplantation|
12064657|NCT00004158|Radiation|holmium Ho 166 DOTMP|
12064658|NCT00004104|Biological|liposomal interleukin-2|
12064659|NCT00004104|Biological|polyvalent melanoma vaccine|
12064660|NCT00004104|Biological|recombinant interferon alfa|
12064661|NCT00004060|Drug|exatecan mesylate|
12064662|NCT00004047|Drug|exatecan mesylate|
12064663|NCT00004041|Biological|Ad5CMV-p53 gene|
12064664|NCT00004041|Procedure|conventional surgery|
12064665|NCT00003881|Biological|trastuzumab|
12064666|NCT00003881|Drug|carboplatin|
12064667|NCT00003881|Drug|paclitaxel|
12064668|NCT00003219|Drug|perillyl alcohol|
12064669|NCT00003196|Drug|chemotherapy|Undergo cytoreductive chemotherapy
12064670|NCT00003196|Radiation|total-body irradiation|Undergo TBI
12064671|NCT00003196|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplant
12064672|NCT00003196|Drug|cyclosporine|Given IV or PO
12064673|NCT00003196|Drug|mycophenolate mofetil|Given PO
12064674|NCT00003196|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC transplant
12064675|NCT00003196|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
12064676|NCT00003171|Drug|bryostatin 1|
12064677|NCT00003082|Biological|monoclonal antibody A27.15|
12064678|NCT00003082|Biological|monoclonal antibody E2.3|
12064679|NCT00003057|Drug|loperamide hydrochloride|
12064680|NCT00003057|Drug|octreotide acetate|
12064681|NCT00002998|Drug|cisplatin|
12064682|NCT00002998|Drug|gemcitabine hydrochloride|
12064683|NCT00002994|Biological|interleukin 2|low dose: 1 million IU/square meter subq injection q day days 1-7 and 11-20 cycle 1; days 4-14 subsequent cycles Intermediate dose: 12 million IU/square meter subq injection on days 8-10 of cycle 1; days 1-3 of subsequent cycles
12064684|NCT00002994|Biological|rhuMAb|90 min IV infusion day 7 of each cycle
12064685|NCT00002956|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes|
12064686|NCT00002925|Drug|ara-C|
12064687|NCT00002925|Drug|Daunorubicin|
12064688|NCT00002925|Drug|Etoposide|
12064689|NCT00002925|Drug|PSC-833|
12064690|NCT00002925|Biological|Aldesleukin|
12064691|NCT00002908|Drug|bryostatin 1|
12064692|NCT00002908|Drug|vincristine sulfate|
12064693|NCT00002907|Drug|bryostatin 1|
12064694|NCT00002862|Drug|perillyl alcohol|
12064695|NCT00002763|Biological|recombinant interferon alfa|
12064696|NCT00002760|Drug|ketoconazole|400 mg PO tid for as long as treatment is effective
12064697|NCT00002760|Drug|therapeutic hydrocortisone|hydrocortisone 30 mg PO q am and 10 mg PO qhs for as long as treatment is effective
12065314|NCT00005041|Drug|tipifarnib|
12064698|NCT00002760|Other|Withdrawal of antiandrogen therapy|no drugs given
12064699|NCT00002667|Other|cytology specimen collection procedure|
12064700|NCT00002667|Other|immunoenzyme technique|
12064701|NCT00002667|Procedure|study of high risk factors|
12064702|NCT00002620|Drug|carmustine|
12064703|NCT00002620|Drug|chemotherapy|
12064704|NCT00002620|Drug|mitolactol|
12064705|NCT00002620|Radiation|low-LET cobalt-60 gamma ray therapy|
12064706|NCT00002620|Radiation|low-LET photon therapy|
12064707|NCT00002563|Procedure|psychosocial assessment and care|Evaluate psychosocial function at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.
12064708|NCT00002563|Procedure|quality-of-life assessment|Evaluate quality of life at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.
12064709|NCT00002557|Drug|CHOP regimen|
12064710|NCT00002557|Drug|doxorubicin hydrochloride|
12064711|NCT00002557|Drug|etoposide|
12064712|NCT00002557|Drug|leucovorin calcium|
12064713|NCT00002557|Drug|methotrexate|
12064714|NCT00002549|Biological|filgrastim|
12064715|NCT00002549|Drug|busulfan|
12064716|NCT00002549|Drug|cyclophosphamide|
12064717|NCT00002549|Drug|cytarabine|
12064718|NCT00002549|Drug|daunorubicin hydrochloride|
12064719|NCT00002549|Drug|etoposide|
12064720|NCT00002549|Drug|idarubicin|
12064721|NCT00002549|Drug|mesna|
12064722|NCT00002549|Drug|mitoxantrone hydrochloride|
12064723|NCT00002549|Procedure|allogeneic bone marrow transplantation|
12064724|NCT00002549|Procedure|autologous bone marrow transplantation|
12064725|NCT00002549|Procedure|peripheral blood stem cell transplantation|
12064726|NCT00002549|Radiation|radiation therapy|
12064727|NCT00002545|Drug|carmustine|
12064728|NCT00002545|Radiation|low-LET photon therapy|
12064729|NCT00002502|Drug|busulfan|
12064730|NCT00002502|Drug|cyclophosphamide|
12064731|NCT00002502|Drug|cytarabine|
12064732|NCT00002502|Procedure|allogeneic bone marrow transplantation|
12064733|NCT00002495|Drug|doxorubicin hydrochloride|25 mg/m^2 on days 1 and 15
12064734|NCT00002495|Drug|vinblastine|6 mg/m^2 on days 1 and 15
12064735|NCT00002495|Radiation|standard subtotal nodal irradiation|3600-4000 cGy delivered over 20 fractions
12064736|NCT00002465|Drug|megestrol acetate|
12064737|NCT00087854|Drug|Amonafide L-malate (drug)|
12064738|NCT00087841|Behavioral|Self-hypnotic relaxation|
12064739|NCT00087828|Drug|Cranberry juice cocktail|
12064740|NCT00087815|Drug|dexamethasone|
12064741|NCT00087815|Drug|hyperbaric oxygen|
12064742|NCT00087815|Procedure|cognitive assessment|
12064743|NCT00087815|Procedure|magnetic resonance imaging|
12064744|NCT00087815|Procedure|positron emission tomography|
12064745|NCT00087815|Procedure|quality-of-life assessment|
12064746|NCT00087802|Drug|gemcitabine/Eloxatin (GEMOX)|GEMOX [gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days [3-week cycle]
12064747|NCT00087802|Drug|carboplatin/paclitaxel (CP)|"CP [carboplatin/paclitaxel - 21 day cycle]
~o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days [3-week cycle]"
12064748|NCT00087789|Genetic|CERE-110: Adeno-Associated Virus Delivery of NGF|CERE-110 2.0 x 10^10 vg, CERE-110 1.0 x 10^11 vg, CERE-110 2.0 x 10^11 vg
12064749|NCT00087776|Drug|Chemotherapy|
12064750|NCT00087763|Drug|Macugen ™ (pegaptanib sodium injection)|
12064751|NCT00087750|Drug|Quetiapine|
12064752|NCT00087737|Drug|DVS-233 SR|
12064753|NCT00087737|Drug|Venlafaxine ER|
12064754|NCT00087711|Drug|pemetrexed|500 mg/m2, IV q 21 days x 6 cycles
12064755|NCT00087711|Drug|gemcitabine|1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
12064756|NCT00087711|Drug|cisplatin|75 mg/m2, IV, q 21 days x 6 cycles
12064757|NCT00087698|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 4 cycles
12064758|NCT00087698|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 4 cycles
12064759|NCT00082511|Drug|Prasterone (GL701)|"There were 4 arms to the study:
~During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study."
12064760|NCT00003877|Biological|filgrastim|
12064761|NCT00003877|Drug|carboplatin|
12064762|NCT00003877|Drug|cyclophosphamide|
12064763|NCT00003877|Drug|paclitaxel|
12064764|NCT00003877|Drug|thiotepa|
12064765|NCT00003877|Procedure|in vitro-treated bone marrow transplantation|
12064766|NCT00003877|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12064767|NCT00003874|Biological|monoclonal antibody CD19|
12064768|NCT00003874|Biological|monoclonal antibody CD20|
12064769|NCT00003874|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12064770|NCT00003873|Drug|fluorouracil|Given IV or orally
12064771|NCT00003873|Drug|eniluracil|Given orally
12064772|NCT00003853|Drug|4'-iodo-4'-deoxydoxorubicin|
12064773|NCT00003805|Drug|piperacillin sodium|
12064774|NCT00003805|Drug|piperacillin-tazobactam|
12064775|NCT00003805|Drug|tazobactam sodium|
12064776|NCT00003805|Drug|vancomycin|
12064777|NCT00003804|Biological|dactinomycin|
12064778|NCT00003804|Drug|vincristine sulfate|
12064779|NCT00003804|Procedure|conventional surgery|
12064780|NCT00003792|Biological|MART-1 antigen|
12064781|NCT00003792|Biological|filgrastim|
12064782|NCT00003792|Biological|flu matrix peptide p58-66|
12064783|NCT00003792|Biological|gp100 antigen|
12064784|NCT00003792|Biological|recombinant MAGE-3.1 antigen|
12064785|NCT00003792|Biological|tyrosinase peptide|
12064786|NCT00003792|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12064787|NCT00003743|Biological|aldesleukin|
12064788|NCT00003664|Biological|aldesleukin|
12064789|NCT00003664|Biological|recombinant interferon alfa|
12064790|NCT00003664|Drug|fluorouracil|
12064791|NCT00003664|Drug|gemcitabine hydrochloride|
12064792|NCT00003639|Biological|recombinant interferon alfa|
12064793|NCT00003639|Drug|chlorambucil|
12064794|NCT00003639|Drug|dexamethasone|
12064795|NCT00003639|Drug|idarubicin|
12064796|NCT00003604|Biological|aldesleukin|
12064797|NCT00003359|Drug|batabulin sodium|
12064798|NCT00003343|Drug|endocrine-modulating drug therapy|
12064799|NCT00003343|Drug|mitoxantrone hydrochloride|
12064800|NCT00003343|Drug|prednisone|
12064801|NCT00003343|Drug|prinomastat|
12064802|NCT00003328|Drug|porfiromycin|
12064803|NCT00003328|Radiation|radiation therapy|
12064804|NCT00087724|Drug|FK962|
12064805|NCT00087685|Drug|RAD001|10 mg by mouth Daily
12064806|NCT00087672|Drug|CC-5013|10 mg orally (2 capsules) daily
12064807|NCT00087659|Drug|zoledronic acid|
12064808|NCT00087646|Drug|Ribavirin|1000/1200mg po daily for 72 weeks
12064809|NCT00087646|Drug|Ribavirin|1000/1200mg po daily for 48 weeks
12064810|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
12064811|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.
12064812|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 72 weeks
12064813|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 48 weeks
12064814|NCT00087633|Drug|peginterferon alfa-2a [Pegasys]|135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
12064815|NCT00087633|Drug|Copegus|400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
12064816|NCT00087620|Drug|XELODA [capecitabine]|
12064817|NCT00087607|Drug|Ribavirin|1000/1200mg/day po
12064818|NCT00087607|Drug|Peginterferon alfa-2b (PEG-Intron)|1.5 micrograms/kg sc weekly
12064819|NCT00087607|Drug|Ribavirin|1000/1200mg/day po
12064820|NCT00087607|Drug|Peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly
12064821|NCT00087594|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)
12064822|NCT00087594|Drug|ribavirin|1000/1200mg (< or >= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)
12064823|NCT00087581|Drug|Mycophenolate mofetil|Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. In Groups A and B, subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. In Group C, subsequent doses are not to be adjusted, except in the case of unacceptable toxicity.
12064824|NCT00087581|Drug|Cyclosporine|Cyclosporine will be given as 100-mg soft gelatin capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 125-165 ng/mL (reduced) or 250-270 ng/mL (full); Days 90 through end of study, 95-145 ng/mL (reduced) or 190-220 ng/mL (full).
12064825|NCT00087581|Drug|Tacrolimus|Tacrolimus will be given as 1-mg and 5-mg capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL (reduced), 8-10 ng/mL (full); Days 90 through end of study, 3-5 ng/mL (reduced), 6-8 ng/mL (full).
12064826|NCT00087568|Drug|Ribavirin|1000/1200mg po bid for 36 or 60 weeks
12064827|NCT00087568|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
12064828|NCT00087555|Drug|Xyrem (sodium oxybate) oral solution|Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.
12064829|NCT00087555|Drug|Xyrem (sodium oxybate) oral solution|Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.
12064830|NCT00087555|Drug|Placebo|Placebo one of two doses matching active treatment by volume for 8 weeks.
12064831|NCT00087542|Drug|ACP-103|
12064832|NCT00087529|Drug|placebo|Intravenous repeating dose
12064833|NCT00087529|Drug|rituximab|Intravenous repeating dose
12064834|NCT00087516|Drug|Sitagliptin (MK0431)|Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
12064835|NCT00087516|Drug|Sitagliptin|Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
12064836|NCT00087516|Drug|Placebo|Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
12064837|NCT00087516|Drug|Placebo|Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
12064838|NCT00087516|Drug|Metformin - Rescue|Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
12064839|NCT00087503|Drug|Edotecarin|
12064840|NCT00087490|Drug|linezolid|
12064841|NCT00087490|Drug|vancomycin|
12064842|NCT00087477|Drug|Pivanex|
12064843|NCT00087464|Drug|Emtricitabine|
12064844|NCT00087464|Drug|Nevirapine|
12064845|NCT00087464|Drug|Tenofovir disoproxil fumarate|
12064846|NCT00087451|Drug|AP23573|ridaforolimus
12064847|NCT00086710|Drug|Fuzeon|
12064848|NCT00086645|Drug|citalopram hydrobromide|10mg/5ml solution
12064849|NCT00086645|Other|placebo|up to equivalent of 20 mg of active comparator daily
12064851|NCT00003589|Drug|gemcitabine hydrochloride|
12064852|NCT00003589|Drug|paclitaxel|
12064853|NCT00087438|Radiation|stereotactic body radiation therapy|
12064854|NCT00087425|Biological|rituximab|
12064855|NCT00087425|Drug|bryostatin 1|
12064856|NCT00087412|Drug|erlotinib hydrochloride|Given orally
12064857|NCT00087412|Other|laboratory biomarker analysis|Correlative studies
12064858|NCT00087399|Drug|gabapentin|
12064859|NCT00087399|Drug|antidepressant|
12064860|NCT00087386|Drug|tanespimycin|Given IV
12064861|NCT00087386|Other|laboratory biomarker analysis|Correlative studies
12064862|NCT00087373|Biological|recombinant fowlpox-TRICOM vaccine|Given intratumorally
12064863|NCT00087373|Other|laboratory biomarker analysis|Correlative studies
12064864|NCT00087360|Other|counseling intervention|
12064865|NCT00087360|Other|physiologic testing|
12064866|NCT00087360|Procedure|evaluation of cancer risk factors|
12064867|NCT00087347|Drug|ferumoxytol|
12064868|NCT00087347|Procedure|magnetic resonance imaging|
12064869|NCT00087334|Drug|capecitabine|
12064870|NCT00087334|Drug|gefitinib|
12064871|NCT00087334|Drug|oxaliplatin|
12064872|NCT00087295|Drug|Depsipeptide|Depsipeptide wil be given 13 mg/m^2 through an intravenous (IV) over 4 hours on day 1, 8, and 15 for every 28 days (1 cycle = 28 days) until progression. Patients achieving a complete response (CR) will receive two additional cycles of treatment, and then be removed from protocol treatment.
12064873|NCT00087282|Drug|alvocidib|
12064874|NCT00087282|Drug|irinotecan hydrochloride|
12064875|NCT00087269|Drug|erlotinib hydrochloride|Given orally
12064876|NCT00087269|Procedure|therapeutic endoscopic surgery|Undergo surgical resection
12064877|NCT00087269|Other|laboratory biomarker analysis|Correlative studies
12064878|NCT00087256|Drug|Celecoxib|
12064879|NCT00087256|Other|placebo|
12064880|NCT00087217|Drug|tanespimycin|Given IV
12064881|NCT00087217|Drug|paclitaxel|Given IV
12064882|NCT00087217|Other|laboratory biomarker analysis|Correlative studies
12064883|NCT00087217|Other|pharmacological study|Correlative studies
12064884|NCT00087204|Drug|becatecarin|Given IV
12064885|NCT00087204|Other|laboratory biomarker analysis|Correlative studies
12064886|NCT00087191|Drug|EF5|Given IV
12064887|NCT00087191|Drug|motexafin lutetium|Given IV
12064888|NCT00087191|Other|pharmacological study|Correlative studies
12064889|NCT00087178|Drug|cyclophosphamide|Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
12064890|NCT00087178|Drug|adriamycin|adriamycin 60 mg/m2 IV every 21 days for 4 cycles
12064891|NCT00087178|Drug|epirubicin|epirubicin 100 mg/m2 IV every 21 days for 6 cycles
12064892|NCT00087178|Drug|fluorouracil|fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
12064893|NCT00087165|Biological|GTI-2040|
12064894|NCT00087165|Drug|docetaxel|
12064895|NCT00087165|Drug|prednisone|
12064896|NCT00087152|Drug|Capecitabine|1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle
12064897|NCT00087152|Drug|Imatinib mesylate|400 mg by mouth daily
12064898|NCT00087139|Drug|ixabepilone|Given IV
12064899|NCT00087126|Drug|topotecan hydrochloride|
12064900|NCT00087113|Drug|pemetrexed disodium|
12064901|NCT00087100|Drug|pemetrexed disodium|
12064902|NCT00087087|Drug|pemetrexed disodium|
12064903|NCT00087074|Drug|temsirolimus|Given IV
12064904|NCT00087074|Other|laboratory biomarker analysis|Optional correlative studies
12064905|NCT00087061|Drug|gimatecan|
12064906|NCT00087048|Drug|topotecan hydrochloride|
12064907|NCT00087035|Drug|docetaxel|Administered as an IV infusion of 60m/m2 over a 1-hour period, once every 21 ± 2 days
12064908|NCT00087035|Drug|erlotinib hydrochloride|Will be taken at a starting daily dose of 150mg
12064909|NCT00087022|Biological|girentuximab|Given IV
12064910|NCT00087022|Other|placebo|Given IV
12064911|NCT00087009|Biological|beta-glucan|Given orally
12064912|NCT00087009|Biological|rituximab|Given IV
12064913|NCT00086996|Drug|fluorouracil|Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.
12064914|NCT00086996|Drug|oxaliplatin|Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.
12064915|NCT00086996|Procedure|conventional surgery|The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
12064916|NCT00086996|Radiation|radiation therapy|Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.
12064917|NCT00086983|Drug|becatecarin|Given IV
12064918|NCT00086983|Drug|oxaliplatin|Given IV
12064919|NCT00086983|Other|pharmacological study|Correlative studies
12064920|NCT00086970|Drug|ifosfamide|Given IV
12064921|NCT00086970|Drug|O6-benzylguanine|Given IV
12064922|NCT00086957|Biological|trastuzumab|Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.
12064923|NCT00086957|Drug|docetaxel|75 mg/m2 every three weeks, or 60 mg/m2 every three weeks depending on study findings
12064924|NCT00086957|Drug|gefitinib|250 mg daily or 250 mg daily on days 2 through 14 depending on study findings
12064925|NCT00086944|Biological|oblimersen sodium|Given IV
12064926|NCT00086944|Biological|rituximab|Given IV
12064927|NCT00086944|Drug|ifosfamide|Given IV
12064928|NCT00086944|Drug|carboplatin|Given IV
12064929|NCT00086944|Drug|etoposide|Given IV
12064930|NCT00086944|Biological|filgrastim|Given SC
12064931|NCT00086944|Biological|pegfilgrastim|Given SC
12064932|NCT00086944|Other|laboratory biomarker analysis|Correlative studies
12064933|NCT00086931|Drug|capecitabine|oral dose escalating, twice daily.
12064934|NCT00086931|Drug|oxaliplatin|IV over 2 hours on days 1, 8, 15, 22, and 29.
12064935|NCT00086931|Procedure|conventional surgery|curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy
12064936|NCT00086931|Procedure|neoadjuvant therapy|chemotherapy and radiation prior to surgery
12064937|NCT00086931|Radiation|radiation therapy|once daily 5 days a week for 5.5 weeks
12064938|NCT00086892|Biological|cetuximab|
12064939|NCT00086892|Drug|carboplatin|
12064940|NCT00086879|Drug|carmustine|
12064941|NCT00086879|Drug|erlotinib hydrochloride|
12064942|NCT00086879|Drug|temozolomide|
12064943|NCT00086866|Biological|D1/3-MAGE-3-His fusion protein|
12064944|NCT00086866|Biological|SB-AS02B adjuvant|
12064945|NCT00086866|Biological|SB-AS15 adjuvant|
12064946|NCT00086840|Drug|temsirolimus|Given IV
12064947|NCT00086840|Other|laboratory biomarker analysis|Correlative studies
12064948|NCT00086827|Drug|romidepsin|Given IV
12064949|NCT00086827|Other|laboratory biomarker analysis|Correlative studies
12064950|NCT00086801|Drug|doxorubicin hydrochloride|given IV
12064951|NCT00086801|Drug|gemcitabine hydrochloride|given IV
12064952|NCT00086801|Drug|vinblastine|given IV
12064953|NCT00086801|Procedure|fludeoxyglucose F 18 positron-emission tomography (PET) scan|
12064954|NCT00086801|Procedure|CT scan|
12064955|NCT00086775|Biological|alemtuzumab|
12064956|NCT00086775|Biological|rituximab|
12064957|NCT00086775|Drug|fludarabine phosphate|
12064958|NCT00086762|Behavioral|MR Therapy|Arm I: Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. Instructions given on breathing techniques and other practices to help relax mind and body.
12064959|NCT00086762|Behavioral|Relaxing Music (RM) Therapy|Participants listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment
12064960|NCT00086762|Behavioral|Standard Symptom Management|Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
12064961|NCT00086762|Behavioral|Questionnaires|Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
12064962|NCT00086736|Drug|bicalutamide|
12064963|NCT00086736|Drug|eflornithine|
12064964|NCT00086736|Drug|oral eflornithine placebo|
12064965|NCT00086736|Drug|oral bicalutamide placebo|
12064966|NCT00086723|Biological|recombinant tissue plasminogen activator|
12064967|NCT00086723|Drug|captopril|
12064968|NCT00086684|Drug|Pentosan polysulfate sodium 100 mg|One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
12064969|NCT00086684|Drug|Placebo|One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks
12064970|NCT00086684|Drug|Pentosan polysulfate sodium 100 mg|One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks
12064971|NCT00086671|Drug|ABT-874/Human monoclonal antibody against IL-12|
12064972|NCT00086671|Drug|Placebo|
12064973|NCT00086658|Drug|mepolizumab|
12064974|NCT00086632|Drug|oregovomab|
12064975|NCT00086606|Drug|Xolair (omalizumab)|
12064976|NCT00086619|Drug|synthetic hPTH 1-34|Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34
12064977|NCT00086593|Drug|lamotrigine|
12064978|NCT00086580|Biological|FluCAM [Fludara + Campath]|"Phase A: Escalating Doses of alemtuzumab (Campath) Alone
~Day 1: alemtuzumab 3 mg intravenously (IV) over 2 hours.
~Day 2: alemtuzumab 10 mg IV over 2 hours if 3 mg was tolerated, else repeat 3 mg daily until tolerated.
~Day 3: alemtuzumab 30 mg IV over 2 hours if 10 mg was tolerated, else repeat 10 mg daily until tolerated.
~Participants were allowed 3-14 days to escalate to 30 mg. Once 30 mg was tolerated, the participant had to begin Phase B within 7 days.
~Phase B: FluCAM
~Cycle 1: Days 1,2,3 fludarabine phosphate administered at 30 mg/m^2 over 30 minutes IV, followed within 1 hour by alemtuzumab 30 mg IV over 2 hours. A similar schedule is set for Cycles 2 through 6; duration of alemtuzumab infusions vary from 2-6 hours. Each 28-day period is 1 cycle. Fludarabine phosphate dosage is based on participants' body surface area at the beginning of each cycle. FluCAM administered up to a maximum of 6 cycles, based upon participants' response to therapy and toxicity."
12064979|NCT00086580|Biological|fludarabine phosphate|Fludarabine phosphate (Fludara) is administered at a dose of 25 mg/m^2 IV over 15 to 30 minutes daily for 5 consecutive days (days 1 through 5) every 28 days (per package instructions). Each 28-day period is 1 cycle. The dose of fludarabine phosphate will be based on the participant's body surface area as calculated at the beginning of each cycle. Participants treated with fludarabine phosphate up to a maximum of 6 cycles, based upon their response to therapy and toxicity.
12064980|NCT00003297|Drug|mitoxantrone hydrochloride|
12064981|NCT00003297|Drug|thiotepa|
12064982|NCT00003297|Drug|topotecan hydrochloride|
12064983|NCT00003297|Procedure|peripheral blood stem cell transplantation|
12064984|NCT00003296|Biological|filgrastim|
12064985|NCT00003296|Drug|pegylated liposomal doxorubicin hydrochloride|
12064986|NCT00003230|Drug|paclitaxel|
12064987|NCT00003198|Drug|ifosfamide|
12064988|NCT00003198|Drug|topotecan hydrochloride|
12064989|NCT00003109|Drug|irinotecan hydrochloride|
12064990|NCT00003109|Drug|raltitrexed|
12064991|NCT00086541|Drug|Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks|
12064992|NCT00086528|Drug|XL647|Administered orally as a solution with mass-based dosing in early cohorts or as 50-mg tablets at a fixed dose at the MTD. A minimum of 3 subjects was planned for each dosing cohort with dose escalation dependent on subject tolerance of the prior dose. During the Treatment Period, subjects in each cohort were administered a single dose of XL647 on Day 1 followed by a 72-hour period of observation. If there were no XL647-related dose limiting toxicities, subjects received 5 daily doses of XL647 on Days 4-8. Twenty-one days after the initial dose, in the absence of unacceptable toxicity or disease progression, subjects could enter a Treatment Extension Period that consisted of repeated 2-week cycles of five oral doses of XL647 followed by a 9-day observation period.
12065487|NCT00085449|Drug|melphalan|
12064993|NCT00086411|Drug|nicotine transdermal system|starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
12064994|NCT00086411|Drug|bupropion|150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
12064995|NCT00086411|Behavioral|Medication Management|Brief manual based therapy; four 15 minute session over 10 weeks.
12064996|NCT00086411|Behavioral|Mayo Counseling|Manual based therapy; Weekly 30 minute sessions for 10 weeks
12064997|NCT00086411|Drug|placebo patch|placebo patch containing no nicotine
12064998|NCT00086411|Drug|placebo bupropion|placebo pills
12064999|NCT00086398|Behavioral|Behavior Therapy|
12065000|NCT00086385|Drug|Nicotine polacrilex, Bupropion|Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
12065001|NCT00003091|Biological|aldesleukin|
12065002|NCT00003091|Biological|recombinant interferon alfa|
12065003|NCT00002953|Drug|cyclophosphamide|
12065004|NCT00002953|Drug|epirubicin hydrochloride|
12065005|NCT00002953|Drug|paclitaxel|
12065006|NCT00002922|Drug|paclitaxel|
12065007|NCT00002863|Drug|chemotherapy|
12065008|NCT00002863|Procedure|conventional surgery|
12065009|NCT00002863|Procedure|cryosurgery|
12065010|NCT00086515|Drug|Sitagliptin (MK0431)|Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
12065011|NCT00086515|Drug|Placebo/Glipizide 5 mg|Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
12065012|NCT00086515|Drug|Metformin|Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
12065013|NCT00086515|Drug|Pioglitazone|Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
12065014|NCT00086502|Drug|Comparator: Sitagliptin|Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24
12065015|NCT00086502|Drug|Comparator: Placebo|Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24
12065016|NCT00086502|Drug|Comparator: Pioglitazone|Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
12065017|NCT00086502|Drug|Metformin|"Metformin rescue for patients meeting
~pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8"
12065018|NCT00086489|Drug|CP-675,206|pts treated at 10 mg/kg dose level on a monthly regimen
12065019|NCT00086489|Drug|CP-675,206|pts treated at 15 mg/kg dose level on a quarterly regimen
12065020|NCT00086463|Drug|Iloprost or placebo|
12065021|NCT00086450|Procedure|Coronary Artery Bypass Graft|For CABG, participants will receive general anesthesia and will have a breathing tube placed in their throat and they will be unconscious during the operation. An incision is made through the chest bone and muscle, which allows the surgeon access to the heart and diseased vessels. The surgeon will use one or more healthy vessels (either from an artery in the shoulder or a vein in the leg) and will bypass the diseased vessel with the healthy vessel(s). This bypass will provide needed blood supply to the heart.
12065022|NCT00086450|Device|Percutaneous Coronary Intervention|"For PCI, the participant will have two or more drug-eluting stents permanently implanted in their clogged arteries. Drug-eluting stents are coated with a drug that may prevent the disease in the vessel from coming back. The brand names of the stents used in this study are TAXUS and CYPHER.
~The participant will receive a local anesthetic. A small puncture will be made and a balloon-tipped catheter is introduced through the small puncture in the leg/arm and advanced through the artery to the diseased heart vessel. The balloon is then inflated to enlarge the opening in the vessel. After enlarging the vessel, the drug-eluting stent will be placed using a similar balloon catheter. This balloon will be inflated, expanding the stent and placing it in the diseased vessel. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery."
12065023|NCT00002999|Drug|cisplatin|
12065024|NCT00002999|Drug|fluorouracil|
12065025|NCT00002999|Radiation|radiation therapy|
12065026|NCT00086346|Drug|Sirolimus (Rapamune)|
12065027|NCT00086346|Drug|Cyclosporine or Tacrolimus|
12065028|NCT00086333|Drug|SGN-15, Docetaxel|
12065029|NCT00086359|Drug|Abacavir sulfate, lamivudine, and zidovudine|one pill twice daily
12065030|NCT00086359|Drug|Lamivudine/zidovudine|one pill twice daily
12065031|NCT00086359|Drug|Lopinavir/ritonavir|four pills twice daily
12065032|NCT00086320|Drug|Paliperidone ER|
12065033|NCT00086281|Drug|Xyrem (X)|Xyrem (Sodium Oxybate) Oral Solution
12065034|NCT00086281|Drug|Zolpidem (Z)|Zolpidem 10 mg oral tablets
12065035|NCT00086281|Drug|Modafinil (M)|Modafinil Oral Tablets
12065036|NCT00086281|Drug|Placebo (P)|Placebo Oral Solution
12065037|NCT00086268|Drug|zoledronic acid|
12065038|NCT00086268|Drug|Taxotere|
12065039|NCT00086268|Drug|Carboplatin|
12065040|NCT00002837|Biological|Filgrastim (G-CSF)|
12065041|NCT00002837|Drug|Cyclophosphamide|
12065042|NCT00002837|Drug|Doxorubicin Hydrochloride|
12065043|NCT00002837|Drug|Paclitaxel|
12065044|NCT00002837|Procedure|Peripheral Blood Stem Cell Transplantation|
12065045|NCT00002804|Biological|filgrastim|
12065046|NCT00002804|Drug|doxorubicin hydrochloride|
12065047|NCT00002804|Drug|ifosfamide|
12065048|NCT00002804|Drug|mesna|
12065049|NCT00002804|Drug|vincristine sulfate|
12065050|NCT00002804|Procedure|conventional surgery|
12065051|NCT00002804|Radiation|brachytherapy|
12065052|NCT00002804|Radiation|low-LET cobalt-60 gamma ray therapy|
12065053|NCT00002804|Radiation|low-LET electron therapy|
12065054|NCT00002804|Radiation|low-LET photon therapy|
12065055|NCT00002751|Biological|monoclonal antibody Me1-14 F(ab')2|
12065056|NCT00002733|Biological|aldesleukin|
12065057|NCT00002733|Biological|recombinant interferon alfa|
12065058|NCT00002733|Biological|therapeutic tumor infiltrating lymphocytes|
12065059|NCT00002733|Drug|cimetidine|
12065060|NCT00002705|Drug|topotecan hydrochloride|
12065061|NCT00002704|Biological|filgrastim|
12065062|NCT00002704|Drug|asparaginase|
12065063|NCT00002704|Drug|cyclophosphamide|
12065064|NCT00002704|Drug|daunorubicin hydrochloride|
12065065|NCT00002704|Drug|dexamethasone|
12065066|NCT00002704|Drug|etoposide|
12065067|NCT00002704|Drug|leucovorin calcium|
12065068|NCT00002704|Drug|liposomal cytarabine|
12065069|NCT00002704|Drug|mercaptopurine|
12065070|NCT00002704|Drug|mesna|
12065071|NCT00002704|Drug|methotrexate|
12065072|NCT00002704|Drug|therapeutic hydrocortisone|
12065073|NCT00002704|Drug|thiotepa|
12065074|NCT00002704|Drug|vincristine sulfate|
12065075|NCT00002704|Radiation|low-LET electron therapy|
12065076|NCT00002704|Radiation|low-LET photon therapy|
12065077|NCT00002691|Biological|filgrastim|
12065078|NCT00002691|Drug|asparaginase|
12065079|NCT00002691|Drug|cyclophosphamide|
12065080|NCT00002691|Drug|cytarabine|
12065081|NCT00002691|Drug|daunorubicin hydrochloride|
12065082|NCT00002691|Drug|dexamethasone|
12065083|NCT00002691|Drug|etoposide|
12065084|NCT00002691|Drug|leucovorin calcium|
12065085|NCT00002691|Drug|mesna|
12065086|NCT00002691|Drug|methotrexate|
12065087|NCT00002691|Drug|vincristine sulfate|
12065088|NCT00002654|Drug|chemotherapy|
12065089|NCT00002654|Drug|cisplatin|
12065090|NCT00002654|Radiation|low-LET cobalt-60 gamma ray therapy|
12065091|NCT00002654|Radiation|low-LET electron therapy|
12065092|NCT00002654|Radiation|low-LET photon therapy|
12065093|NCT00086307|Drug|Pramipexole|Pramipexole will be titrated so patients receive the following medication three times per day during the weeks noted: .125 milligrams (mg) in week 1, .250 mg in week 2, .5 mg in week 3, and .75 mg in weeks 4 to 6.
12065094|NCT00086307|Drug|Escitalopram|Escitalopram will be started at 10 mg/day and patients will continue on this throughout the study.
12065095|NCT00086294|Drug|Intravenous Levodopa|
12065096|NCT00086294|Drug|ACP-103|
12065097|NCT00086255|Drug|Tiagabine|
12065098|NCT00086216|Drug|Atiprimod|Oral, once a day, 14 days on 14 days off
12065099|NCT00002642|Drug|cisplatin|50 mg/m2, IV Days 1 and 8, two 28 day cycles prior to surgery and two 28 day cycles after surgery
12065100|NCT00002642|Drug|etoposide|50 mg/m2, IV Days 1-5, two 28 day cycles prior to surgery and two 28 day cycles after surgery
12065101|NCT00002642|Procedure|conventional surgery|surgery some time between weeks 9 and 12
12065102|NCT00002642|Radiation|low-LET cobalt-60 gamma ray therapy|180 cGy per day, Days 1-5, weekly for 5 weeks
12065103|NCT00002565|Biological|bleomycin sulfate|
12065104|NCT00002565|Drug|CHOP regimen|
12065105|NCT00002565|Drug|cisplatin|
12065106|NCT00002565|Drug|cyclophosphamide|
12065107|NCT00002565|Drug|cytarabine|
12065108|NCT00002565|Drug|doxorubicin hydrochloride|
12065109|NCT00002565|Drug|etoposide|
12065110|NCT00002565|Drug|idarubicin|
12065111|NCT00002565|Drug|ifosfamide|
12065112|NCT00002565|Drug|mesna|
12065113|NCT00002565|Drug|methylprednisolone|
12065114|NCT00002565|Drug|mitoxantrone hydrochloride|
12065115|NCT00002565|Drug|prednisone|
12065116|NCT00002565|Drug|vincristine sulfate|
12065117|NCT00086242|Behavioral|Psychosocial Telephone Counseling (PTC)|Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies.
12065118|NCT00086229|Drug|Glucosamine|
12065119|NCT00086229|Drug|Chondroitin|
12065120|NCT00086203|Drug|Talabostat mesylate (PT-100) tablets|
12065121|NCT00086203|Drug|Rituximab|
12065122|NCT00086190|Drug|paroxetine|Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
12065123|NCT00086190|Drug|venlafaxine|Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
12065124|NCT00086190|Other|placebo|an inactive substance
12065125|NCT00086177|Drug|8% progesterone vaginal gel|Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
12065126|NCT00086177|Drug|Placebo Vaginal Gel|Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
12065127|NCT00086164|Drug|edifoligide (E2F Decoy)|
12065128|NCT00086138|Drug|Sertraline (Zoloft)|Sertraline: range of 25 to 125 mg per day for 24 weeks
12065129|NCT00086138|Drug|Placebo|Placebo designed to mimic sertraline taken daily for 24 weeks
12065130|NCT00086125|Drug|ridaforolimus|AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
12065131|NCT00086112|Drug|risperidone oral tablets|
12065132|NCT00006041|Biological|MUC1-KLH conjugate vaccine|
12065133|NCT00006041|Biological|MUC1-KLH vaccine/QS21|
12065134|NCT00006041|Biological|QS21|
12065135|NCT00005975|Drug|Megestrol Acetate 20mg/day|Double blinded Megestrol Acetate 20 mg/day
12065136|NCT00005975|Drug|Megestrol Acetate 40 mg/day|Double blinded Megestrol Acetate 40 mg/day
12065137|NCT00005975|Drug|Megestrol Acetate Placebo 20 mg/day|Megestrol Acetate Placebo 20 mg/day
12065138|NCT00005975|Drug|Megestrol Acetate Placebo 40 mg/day|Megestrol Acetate Placebo 40 mg/day
12065139|NCT00005854|Drug|cyclophosphamide|
12065140|NCT00005854|Drug|cyclosporine|
12065141|NCT00005854|Drug|methotrexate|
12065142|NCT00005854|Procedure|allogeneic bone marrow transplantation|
12065829|NCT00002476|Drug|methotrexate|
12065143|NCT00005854|Procedure|in vitro-treated bone marrow transplantation|
12065144|NCT00005854|Radiation|radiation therapy|
12065145|NCT00002505|Biological|filgrastim|
12065146|NCT00002505|Biological|recombinant interferon gamma|
12065147|NCT00002505|Biological|tumor cell lysate vaccine therapy|
12065148|NCT00002482|Biological|antibody therapy|
12065149|NCT00002482|Biological|biological therapy|
12065150|NCT00002482|Biological|muromonab-CD3|
12065151|NCT00002482|Drug|cyclophosphamide|
12065152|NCT00086099|Drug|Idarubincin and Amufostine (Ethyol)|Starting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36)
12065153|NCT00086099|Drug|Idarubincin|Idarubincin (12mg/m2) and ara-C(N-18)
12065154|NCT00005613|Drug|cyclophosphamide|Cyclophosphamide will be given at a dose of 1500 mg/m2/day IV over 1.0 hour on days -6, -5, -4, and -3.
12065155|NCT00005613|Drug|etoposide|Etoposide will be given at a dose of 600 mg/m2/day over 3.0 hours on days -6, -5, and -4.
12065156|NCT00005613|Drug|BCNU|BCNU will be given at a dose of 150 mg/m2/day in 500 cc D5W over 3.0 hours on days -6, -5, and -4
12065157|NCT00004202|Drug|carboplatin|
12065158|NCT00004202|Drug|chemotherapy|
12065159|NCT00004202|Drug|efaproxiral|
12065160|NCT00004202|Drug|paclitaxel|
12065161|NCT00004202|Radiation|radiation therapy|
12065162|NCT00004197|Biological|keyhole limpet hemocyanin|
12065163|NCT00004197|Biological|sargramostim|
12065164|NCT00004197|Biological|tumor cell-based vaccine therapy|
12065165|NCT00004197|Drug|cyclophosphamide|
12065166|NCT00004197|Drug|doxorubicin hydrochloride|
12065167|NCT00004197|Drug|mitoxantrone hydrochloride|
12065168|NCT00004197|Drug|prednisone|
12065169|NCT00004197|Drug|vincristine sulfate|
12065170|NCT00004192|Biological|filgrastim|
12065171|NCT00004192|Biological|pegfilgrastim|
12065172|NCT00004192|Drug|cisplatin|
12065173|NCT00004192|Drug|cytarabine|
12065174|NCT00004192|Drug|etoposide|
12065175|NCT00004192|Drug|methylprednisolone|
12065176|NCT00003995|Biological|trastuzumab|
12065177|NCT00003995|Drug|irinotecan hydrochloride|
12065178|NCT00003946|Drug|danazol|
12065179|NCT00086086|Drug|Darbepoetin Alfa|
12065180|NCT00003762|Drug|docetaxel|
12065181|NCT00003762|Drug|gemcitabine hydrochloride|
12065182|NCT00003723|Drug|gemcitabine hydrochloride|Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days)
12065183|NCT00003691|Biological|filgrastim|
12065184|NCT00003691|Drug|cisplatin|
12065185|NCT00003691|Drug|doxorubicin hydrochloride|
12065186|NCT00003691|Drug|paclitaxel|
12065187|NCT00003667|Drug|cyclophosphamide|
12065188|NCT00003667|Drug|dexrazoxane hydrochloride|
12065189|NCT00003667|Drug|disaccharide tripeptide glycerol dipalmitoyl|
12065190|NCT00003667|Drug|doxorubicin hydrochloride|
12065191|NCT00003667|Drug|vincristine sulfate|
12065192|NCT00003667|Procedure|surgical procedure|
12065193|NCT00003667|Radiation|radiation therapy|
12065194|NCT00003630|Drug|arsenic trioxide|
12065195|NCT00003549|Drug|CMF regimen|
12065196|NCT00003549|Drug|cyclophosphamide|
12065197|NCT00003549|Drug|fluorouracil|
12065198|NCT00003549|Drug|methotrexate|
12065199|NCT00003369|Drug|cisplatin|75 mg/m2 IV as a one-hour infusion after tirapazamine on Day 1 of each 21-day cycle
12065200|NCT00003369|Drug|tirapazamine|260 mg/m2 over two hours prior to cisplatin on Day 1 of each 21-day cycle
12065201|NCT00003317|Drug|carboplatin|
12065202|NCT00003317|Drug|paclitaxel|
12065203|NCT00003317|Radiation|radiation therapy|
12065204|NCT00003317|Procedure|surgery|
12065205|NCT00003127|Drug|amifostine trihydrate|740 mg/m2 IV, Day 1, q 28 days X 6 cycles
12065206|NCT00003127|Drug|carboplatin|target AUC=6, IV Day 1, q 28 days X 6 cycles
12065207|NCT00003127|Drug|paclitaxel|175 mg/m2, IV, Day 1 q 28 days X 6 cycles
12065208|NCT00086060|Behavioral|Exercise regimen|Aerobic Exercise is a self-management technique that increases personal control over pain by enhancing physical fitness. Patients will be encouraged to choose activities best suited to their tastes and current lifestyle, incorporating lifestyle physical activities (climbing stairs, household chores, etc) and more traditional exercise activities (walking, cycling, etc.). Subjects will use ratings of perceived exertion (RPE) to guide their effort. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for exercise, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
12065209|NCT00086060|Behavioral|Relaxation training|Relaxation is a self-management technique that increases personal control over pain by relaxing tense muscles, allowing the body to rest, and improving mental clarity through concentration and attention and has a great deal of empirical research supporting its effectiveness as a means of pain management. A variety of relaxation skills will be taught with some being based on muscle relaxation, and others focused more on cognitive relaxation and imagery. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for relaxation, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
12065210|NCT00086060|Behavioral|Standard Care|Participants in the standard care control group will not receive any additional intervention beyond that which they are receiving from their routine health care professional.
12065211|NCT00086047|Behavioral|Coping Skills Training|8 weekly sessions of behavioral treatment
12065212|NCT00086047|Behavioral|Education|8 weekly sessions of fibromyalgia education
12065213|NCT00086034|Drug|Motexafin gadolinium|
12065214|NCT00003078|Drug|cisplatin|
12065215|NCT00003078|Drug|fluorouracil|
12065216|NCT00003078|Radiation|brachytherapy|
12065217|NCT00003078|Radiation|radiation therapy|
12065218|NCT00002844|Drug|Cyclophosphamide|Daily intravenous infusions of cyclophosphamide for two days,
12065918|NCT00004071|Drug|leflunomide|
12065219|NCT00002844|Procedure|Allogeneic Bone Marrow Transplantation|After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
12065220|NCT00002844|Procedure|Autologous Bone Marrow Transplantation|After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
12065221|NCT00002844|Radiation|Total Body Irradiation (TBI)|Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
12065222|NCT00002816|Drug|cytarabine|Given IV
12065223|NCT00002816|Drug|dexamethasone|Given IV
12065224|NCT00002816|Drug|etoposide|Given IV
12065225|NCT00002816|Drug|idarubicin|Given IV
12065226|NCT00002816|Drug|ifosfamide|Given IV
12065227|NCT00002816|Drug|leucovorin calcium|
12065228|NCT00002816|Drug|mesna|Given IV
12065229|NCT00002816|Drug|pegaspargase|Given IV
12065230|NCT00002816|Drug|therapeutic hydrocortisone|
12065231|NCT00002816|Drug|thioguanine|
12065232|NCT00002816|Drug|vincristine sulfate|Given IV
12065233|NCT00002816|Radiation|low-LET cobalt-60 gamma ray therapy|
12065234|NCT00002816|Radiation|low-LET electron therapy|
12065235|NCT00002816|Radiation|low-LET photon therapy|
12065236|NCT00002816|Drug|Methotrexate|Given IV
12065237|NCT00002747|Drug|cisplatin|
12065238|NCT00002747|Drug|fluorouracil|
12065239|NCT00002747|Procedure|conventional surgery|
12065240|NCT00002747|Radiation|low-LET cobalt-60 gamma ray therapy|
12065241|NCT00002747|Radiation|low-LET photon therapy|
12065242|NCT00002725|Drug|bryostatin 1|
12065243|NCT00002725|Drug|chemotherapy|
12065244|NCT00086021|Procedure|Acupuncture|
12065245|NCT00085969|Drug|Placebo 0.04 mL twice daily|Subcutaneously injected, 0.04 mL, twice daily
12065246|NCT00085969|Drug|Placebo 0.04 mL once daily|Subcutaneously injected, 0.04 mL, once daily
12065247|NCT00085969|Drug|Placebo 0.08 mL once daily|Subcutaneously injected, 0.08 mL, once daily
12065248|NCT00085969|Drug|B - Exenatide 10 mcg twice daily|Subcutaneously injected, 10 mcg (0.04 mL), twice daily
12065249|NCT00085969|Drug|C - Exenatide 10 mcg once daily|Subcutaneously injected, 10 mcg (0.04 mL), once daily
12065250|NCT00085969|Drug|Exenatide 20 mcg once daily|Subcutaneously injected, 20 mcg (0.08 mL), once daily
12065251|NCT00085956|Drug|Arzoxifene|
12065252|NCT00085956|Drug|Placebo|
12065253|NCT00006241|Biological|filgrastim|
12065254|NCT00006241|Drug|chemotherapy|
12065255|NCT00006241|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12065256|NCT00006241|Procedure|peripheral blood stem cell transplantation|
12065257|NCT00006241|Radiation|radiation therapy|
12065258|NCT00006235|Drug|carboplatin|
12065259|NCT00006235|Drug|pegylated liposomal doxorubicin hydrochloride|
12065260|NCT00006214|Drug|flutamide|
12065261|NCT00006214|Other|placebo|
12065262|NCT00006117|Drug|gemcitabine hydrochloride|
12065263|NCT00006117|Drug|oxaliplatin|
12065264|NCT00006116|Drug|cisplatin|
12065265|NCT00006116|Drug|gemcitabine hydrochloride|
12065266|NCT00006088|Drug|vinorelbine tartrate|
12065267|NCT00002717|Drug|cisplatin|
12065268|NCT00002717|Drug|paclitaxel|
12065269|NCT00002657|Biological|bleomycin sulfate|5 mg/m^2
12065270|NCT00002657|Biological|recombinant interferon alfa|3.0 x 10^6 IU/m^2
12065271|NCT00002657|Drug|cyclophosphamide|650 mg/m^2
12065272|NCT00002657|Drug|cytarabine|300 mg/m^2
12065273|NCT00002657|Drug|doxorubicin hydrochloride|25 mg/m^2
12065274|NCT00002657|Drug|etoposide|120 mg/m^2
12065275|NCT00002657|Drug|methotrexate|120 mg/m^2
12065276|NCT00002657|Drug|prednisone|dose varies during initial immunosuppression. During chemotherapy, 60 mg/m^2.
12065277|NCT00002657|Drug|vincristine sulfate|1.4 mg/m^2
12065278|NCT00002657|Procedure|conventional surgery|Simple excision, for those patients who have resectable disease after initial immunosuppression.
12065279|NCT00002657|Radiation|radiation therapy|For treatment of localized disease that remains after initial immunosuppression.
12065280|NCT00085982|Drug|Metreleptin|Administered SQ twice/day to achieve physiological concentrations that will be effective in improving the severe state of insulin resistance seen in patients with genetic defects on their insulin rece
12065281|NCT00085943|Drug|LEXIVA (GW433908)|
12065282|NCT00085943|Drug|Ritonavir|
12065283|NCT00085943|Drug|KALETRA|
12065284|NCT00085943|Drug|EPIVIR|
12065285|NCT00085943|Drug|Ziagen|
12065286|NCT00085943|Drug|Abacavir/Lamivudine|
12065287|NCT00085943|Drug|Fosamprenavir|
12065288|NCT00085930|Biological|EBV specific CTLs|CTLs: 2x10e7 cells/m2
12065289|NCT00006035|Biological|bleomycin sulfate|
12065290|NCT00006035|Drug|electroporation therapy|
12065291|NCT00006033|Biological|gene therapy|
12065292|NCT00006033|Biological|interleukin-2 gene|
12065293|NCT00006033|Drug|methotrexate|
12065294|NCT00005993|Drug|aldesleukin|
12065295|NCT00005993|Drug|filgrastim|
12065296|NCT00005993|Drug|recombinant human stem cell factor|
12065297|NCT00005993|Procedure|peripheral blood stem cell transplantation|
12065298|NCT00005968|Drug|irofulven|
12065299|NCT00085904|Drug|SB-485232|
12065300|NCT00085891|Drug|Quetiapine Fumarate|
12065301|NCT00085878|Drug|SB-485232|
12065302|NCT00083421|Drug|ONO-2506PO|
12065303|NCT00005829|Drug|gemcitabine hydrochloride|
12065304|NCT00005826|Drug|rubitecan|
12065305|NCT00005616|Procedure|conventional surgery|
12065306|NCT00005616|Procedure|neoadjuvant therapy|
12065307|NCT00005616|Procedure|radionuclide imaging|
12065308|NCT00005616|Radiation|iodine I 131 monoclonal antibody F19|
12065309|NCT00005093|Drug|gemcitabine hydrochloride|
12065310|NCT00005093|Drug|tacedinaline|
12065311|NCT00005073|Drug|zoledronic acid|
12065312|NCT00005048|Drug|estramustine phosphate sodium|
12065313|NCT00005048|Drug|paclitaxel|
12065315|NCT00004929|Biological|MUC-2-KLH vaccine|
12065316|NCT00004929|Biological|QS21|
12065317|NCT00004861|Drug|gemcitabine hydrochloride|
12065318|NCT00004861|Drug|tacedinaline|
12065319|NCT00004260|Biological|recombinant interleukin-12|
12065320|NCT00004260|Biological|rituximab|
12065321|NCT00004217|Biological|filgrastim|5 μg/kg/day IV or SC
12065322|NCT00004217|Biological|sargramostim|5 μg/kg/day IV or SC starting d 15
12065323|NCT00004217|Drug|cytarabine|Ara-C continuous IV: Hours 2.5 - 170.5 before PSC-833
12065324|NCT00004217|Drug|daunorubicin hydrochloride|continuous IV: Hours 2 - 74 before PSC-833
12065325|NCT00004217|Drug|valspodar|2 mg/kg load IV over 2 hrs (loading); 10 mg/kg/day Continuous hours 0 - 96
12065326|NCT00085917|Drug|Double dose pegylated interferon with weight based Ribavirin|pegylated interferon alfa -2a 180ug/twice weekly and weight based ribavirin for 4 weeks then pegylated interferon alfa -2a 180ug/ weekly for the remainder of the treatment
12065327|NCT00085917|Drug|standard dose pegylated interferon alfa -2a and ribavirin|pegylated interferon alfa -2a 180ug weekly and weight based ribavirin for duration of the treatment
12065328|NCT00085852|Biological|BLVR|10 mL Hydrogel
12065329|NCT00085839|Drug|Tarceva (Trademark) (erlotinib HCl, OSI-774)|Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
12065330|NCT00085839|Drug|Combination carboplatin and paclitaxel|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
12065331|NCT00085826|Drug|Exisulind|
12065332|NCT00085813|Drug|Ispinesib|
12065333|NCT00085787|Drug|ARRY-142886, MEK inhibitor; oral|Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule
12065334|NCT00085774|Drug|albuterol aerosol by HFA MDI|albuterol HFA MDI 160 mcg
12065335|NCT00085774|Drug|albuterol aerosol by HFA BOI|albuterol HFA BOI 160 mcg
12065336|NCT00085774|Drug|placebo aerosol by HFA|placebo HFA
12065337|NCT00085761|Drug|Capsaicin Dermal Patch|
12065338|NCT00004251|Drug|letrozole|2.5 mg of letrozole per day
12065339|NCT00004076|Drug|mureletecan|
12065340|NCT00004043|Dietary Supplement|calcitriol|
12065341|NCT00003996|Drug|carmustine|
12065342|NCT00003996|Drug|chemotherapy|
12065343|NCT00003996|Drug|cisplatin|
12065344|NCT00003996|Drug|etoposide|
12065345|NCT00003996|Radiation|radiation therapy|
12065346|NCT00003920|Biological|filgrastim|
12065347|NCT00003920|Drug|cyclosporine|
12065348|NCT00003920|Procedure|peripheral blood stem cell transplantation|
12065349|NCT00003920|Radiation|indium In 111 monoclonal antibody m170|
12065350|NCT00003920|Radiation|yttrium Y 90 monoclonal antibody m170|
12065351|NCT00003898|Dietary Supplement|glutamine|Oral
12065352|NCT00003894|Drug|thalidomide|
12065353|NCT00003891|Drug|lurtotecan liposome|
12065354|NCT00085748|Drug|paliperidone ER|
12065355|NCT00085735|Drug|Cisplatin|Given IV
12065356|NCT00085735|Radiation|Craniospinal Irradiation|Undergo craniospinal Irradiation
12065357|NCT00085735|Drug|Cyclophosphamide|Given IV
12065358|NCT00085735|Radiation|Involved-Field Radiation Therapy|Undergo smaller volume boost (involved-field radiation therapy)
12065359|NCT00085735|Other|Laboratory Biomarker Analysis|Correlative studies
12065360|NCT00085735|Drug|Lomustine|Given orally
12065361|NCT00085735|Other|Quality-of-Life Assessment|Ancillary studies
12065362|NCT00085735|Radiation|Radiation Therapy|Undergo standard volume boost (whole posterior fossa radiation therapy)
12065363|NCT00085735|Drug|Vincristine Sulfate|Given IV
12065364|NCT00085722|Procedure|Dextrose Prolotherapy|Injection procedure: 50% dextrose is diluted with .9% 'normal' saline and 1% lidocaine to achieve 15% dextrose for ligament injections and 25% dextrose for intra-articular injection.
12065365|NCT00085722|Procedure|Saline Prolotherapy|7 mL 9% 'normal' saline and 3mL 1% lidocaine
12065366|NCT00085722|Other|At-home physical therapy exercise group|Subjects in the at-home physical therapy exercise group will receive a patient information pamphlet about knee osteoarthritis and conservative care instructions for standard at-home physical therapy exercises
12065367|NCT00085709|Drug|gemtuzumab ozogamicin|Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses >/= 28 days apart
12065368|NCT00085709|Other|observation|No treatment given
12065369|NCT00085709|Drug|Cytosine arabinoside|IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
12065370|NCT00085709|Drug|Daunomycin|IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
12065371|NCT00085644|Biological|adalimumab (D2E7)|Adalimumab 40 mg every other week, subcutaneous
12065372|NCT00085644|Biological|placebo|Placebo every other week, subcutaneous
12065373|NCT00003871|Biological|fowlpox virus vaccine vector|
12065374|NCT00003871|Biological|recombinant vaccinia prostate-specific antigen vaccine|
12065375|NCT00003860|Biological|filgrastim|
12065376|NCT00003860|Drug|carboplatin|
12065377|NCT00003860|Drug|etoposide|
12065378|NCT00003860|Drug|ifosfamide|
12065379|NCT00003860|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12065380|NCT00003847|Drug|biricodar dicitrate|
12065381|NCT00003847|Drug|doxorubicin hydrochloride|
12065382|NCT00003847|Drug|vincristine sulfate|
12065383|NCT00003829|Drug|cyclophosphamide|
12065384|NCT00003829|Drug|fludarabine phosphate|
12065385|NCT00003720|Drug|semaxanib|
12065386|NCT00003624|Drug|amifostine trihydrate|
12065387|NCT00003624|Drug|cisplatin|
12065388|NCT00003624|Drug|paclitaxel|
12065389|NCT00003592|Drug|methotrexate|
12065390|NCT00003592|Drug|paclitaxel|
12065391|NCT00003574|Procedure|surgical procedure|
12065392|NCT00003574|Radiation|brachytherapy|
12065393|NCT00003574|Radiation|intraoperative radiation therapy|
12065394|NCT00003574|Radiation|iodine I 125|
12065395|NCT00003254|Drug|ethynyluracil|10mg/m2/dose, PO, Days 1-28, q 5wk
12065396|NCT00003254|Drug|fluorouracil|1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
12065397|NCT00003242|Drug|bryostatin 1|
12065398|NCT00003242|Drug|cisplatin|
12065399|NCT00003242|Drug|paclitaxel|
12065400|NCT00003206|Drug|carboplatin|
12065401|NCT00003206|Drug|paclitaxel|
12065402|NCT00003143|Drug|Amifostine|
12065403|NCT00003143|Drug|DHAP|
12065404|NCT00003099|Drug|Fenretinide|Daily for 14-28 days.
12065405|NCT00003099|Drug|Tamoxifen Citrate|Daily for 14-28 days.
12065406|NCT00003099|Other|Placebo|Daily for 14-28 days
12065407|NCT00003085|Procedure|laparoscopy|
12065408|NCT00003085|Procedure|ultrasound imaging|
12065409|NCT00003028|Drug|sabarubicin|
12065410|NCT00003009|Biological|aldesleukin|
12065411|NCT00002973|Drug|melphalan|
12065412|NCT00002973|Procedure|hyperthermia treatment|
12065413|NCT00002949|Drug|paclitaxel|Paclitaxel (qwk, starting dose of 20mg/m2 with planned dose escalation increments of 5mg/m2)
12065414|NCT00002949|Drug|vinorelbine tartrate|Vinorelbine (qwk, 10, 15, 20 or 25 mg/m2),
12065415|NCT00002949|Radiation|radiation therapy|Radiation therapy (Total pelvic RT of 45 Gy in 1.8-Gy daily fractions, 85 Gy in cervical cancer patients using intracavitary brachytherapy, 70 Gy in patients treated with interstitial brachytherapy)
12065416|NCT00002915|Drug|penclomedine|
12065417|NCT00002864|Drug|octreotide acetate|Octreotide LAR (SMS 201-995 pa LAR) 90 mg depot injection monthly for 2 years (plus Tamoxifen 20 mg PO daily for 5 years)
12065418|NCT00002864|Drug|tamoxifen citrate|20 mg PO for 5 years
12065419|NCT00002838|Biological|Filgrastim (G-CSF)|
12065420|NCT00002838|Drug|Cyclophosphamide|
12065421|NCT00002838|Drug|Fludarabine Phosphate|
12065422|NCT00002838|Procedure|Peripheral Blood Stem Cell Transplantation|
12065423|NCT00002785|Biological|filgrastim|
12065424|NCT00002785|Drug|asparaginase|
12065425|NCT00002785|Drug|cyclophosphamide|
12065426|NCT00002785|Drug|cyclosporine|
12065427|NCT00002785|Drug|cytarabine|
12065428|NCT00002785|Drug|daunorubicin hydrochloride|
12065429|NCT00002785|Drug|dexamethasone|
12065430|NCT00002785|Drug|etoposide|
12065431|NCT00002785|Drug|leucovorin calcium|
12065432|NCT00002785|Drug|mercaptopurine|
12065433|NCT00002785|Drug|mesna|
12065434|NCT00002785|Drug|methotrexate|
12065435|NCT00002785|Drug|methylprednisolone|
12065436|NCT00002785|Drug|pegaspargase|
12065437|NCT00002785|Drug|prednisone|
12065438|NCT00002785|Drug|therapeutic hydrocortisone|
12065439|NCT00002785|Drug|vincristine sulfate|
12065440|NCT00002785|Procedure|allogeneic bone marrow transplantation|
12065441|NCT00002785|Radiation|low-LET cobalt-60 gamma ray therapy|
12065442|NCT00002785|Radiation|low-LET photon therapy|
12065443|NCT00002740|Biological|filgrastim|
12065444|NCT00002740|Drug|carboplatin|
12065445|NCT00002740|Drug|cyclophosphamide|
12065446|NCT00002740|Drug|doxorubicin hydrochloride|
12065447|NCT00002740|Drug|etoposide|
12065448|NCT00002740|Drug|mesna|
12065449|NCT00002740|Drug|vincristine sulfate|
12065450|NCT00002740|Procedure|conventional surgery|
12065451|NCT00002740|Procedure|peripheral blood stem cell transplantation|
12065452|NCT00002740|Radiation|low-LET cobalt-60 gamma ray therapy|
12065453|NCT00002740|Radiation|low-LET photon therapy|
12065454|NCT00085696|Drug|VELCADE and rituximab|
12065455|NCT00085631|Drug|cisplatin|Given IV
12065456|NCT00085631|Procedure|hyperthermia treatment|Patients undergo hyperthermia treatment over 60-90 minutes
12065457|NCT00085631|Radiation|brachytherapy|Patients undergo brachytherapy for 2-3 days
12065458|NCT00085631|Radiation|external beam radiation therapy|Patients undergo external beam radiation therapy once daily on days 1-5
12065459|NCT00085579|Biological|aldesleukin|
12065460|NCT00085579|Biological|sargramostim|
12065461|NCT00085579|Procedure|adjuvant therapy|
12065462|NCT00085566|Drug|everolimus|
12065463|NCT00085566|Drug|gefitinib|
12065464|NCT00085553|Drug|Erlotinib Hydrochloride|Given PO
12065465|NCT00085553|Other|Laboratory Biomarker Analysis|Correlative studies
12065466|NCT00085553|Other|Pharmacological Study|Correlative studies
12065467|NCT00085553|Drug|Tipifarnib|Given PO
12065468|NCT00085540|Drug|depsipeptide|Given IV
12065469|NCT00085527|Drug|depsipeptide|
12065470|NCT00085501|Drug|cetuximab|"Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2.
~Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14."
12065471|NCT00085501|Drug|carboplatin|"Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2
~Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1"
12065472|NCT00085501|Drug|paclitaxel|"Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4.
~Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1."
12065473|NCT00085488|Biological|autologous tumor cell vaccine|
12065474|NCT00085488|Biological|therapeutic autologous dendritic cells|
12065475|NCT00085475|Drug|imatinib mesylate|
12065476|NCT00085475|Procedure|conventional surgery|
12065477|NCT00085462|Biological|aldesleukin|
12065478|NCT00085462|Biological|filgrastim|
12065479|NCT00085462|Biological|gp100-fowlpox vaccine|
12065480|NCT00085462|Biological|therapeutic autologous lymphocytes|
12065481|NCT00085462|Biological|therapeutic tumor infiltrating lymphocytes|
12065482|NCT00085462|Drug|cyclophosphamide|
12065483|NCT00085462|Drug|fludarabine phosphate|
12065484|NCT00085449|Biological|alemtuzumab|
12065485|NCT00085449|Drug|cyclosporine|
12065486|NCT00085449|Drug|fludarabine phosphate|
12065488|NCT00085449|Drug|mycophenolate mofetil|
12065489|NCT00085449|Procedure|peripheral blood stem cell transplantation|
12065490|NCT00085449|Radiation|radiation therapy|
12065491|NCT00085436|Biological|Aldesleukin,|Recombinant human interleukin-2 (Proleukin, Chiron Therapeutics) will be administered as a five day (120 hr) continuous intravenous infusion at a dose of 18x106 IU per square meter of body surface area per day as per the Negrier regimen (21). The treatment schedule consists of two induction cycles and three maintenance cycles. Each induction cycle consists of two five-day courses of interleukin-2 infusion separated by a nine-day break. Each maintenance cycle consists of a five-day infusion followed by 23-day rest period of no therapy.
12065492|NCT00085436|Biological|autologous tumor cell vaccine|we will administer 1 X 107 DC cells. The autologous tumor cell vaccine (1 X 107 cells/1cc) in lactated ringers solution and injected into one (or two if clinically necessary) inguinal lymph nodes under ultrasound guidance. Each cycle of DC vaccine will be administered alternately in the right and left inguinal lymph nodes.
12065493|NCT00085436|Biological|recombinant interferon alfa|Recombinant human interferon alfa-2a (Roferon, Roche), at a dose of 6 million IU per day three times a week subcutaneously will be given during the two interleukin-2 induction cycles and during each interleukin-2 maintenance cycle
12065494|NCT00085423|Biological|aldesleukin|‡Interleukin-2 (aldesleukin) IV (600,000 U/kg; Chiron, Emeryville, CA): two 5-day courses on days 8 and 22. Interleukin-2 was given over 15 minutes every 8 hours. Goal is 14 doses/5-day course
12065495|NCT00085423|Biological|sargramostim|GM-CSF was given subcutaneously daily from day 8 until absolute granulocyte count exceeds 5,000 cells/mL for 2 consecutive days.
12065496|NCT00085423|Drug|cyclophosphamide|Cyclophosphamide (60 mg/kg/d; Baxter, Deerfield, IL) intravenously (IV) for 2 days with sodium 2- mercaptoethanesulfonate (Mesna; Sicor, Irvine, CA) at 20% of cyclophosphamide dose IV 15 minutes before and 40% of the cyclophosphamide dose orally at 2 and 6 hours after the initiation of chemotherapy.
12065497|NCT00085423|Drug|fludarabine phosphate|Fludarabine IV (25 mg/M2/day)-five daily doses from Day 3
12065498|NCT00085410|Drug|bortezomib|Given IV
12065499|NCT00085397|Biological|autologous dendritic cell-tumor fusion vaccine|Given subcutaneously
12065500|NCT00085397|Biological|gp100 antigen|Given IV
12065501|NCT00085397|Biological|therapeutic autologous dendritic cells|Given IV
12065502|NCT00085384|Biological|PEG-interferon alfa-2b|Starting dose 1.0 mg/kg/week given subcutaneously
12065503|NCT00085384|Drug|PEG-interferon alfa-2b|"Biological/Vaccine: PEG-interferon alfa-2b
~Dose 1.25 mg/kg/week given subcutaneously"
12065504|NCT00085384|Biological|PEG-interferon alfa-2b|"Biological/Vaccine: PEG-interferon alfa-2b
~Dose 1.5 mg/kg/week given subcutaneously
~EG-Intron"
12065505|NCT00085371|Drug|triapine|Given IV
12065506|NCT00085358|Drug|carboplatin|Given intraperitoneally
12065507|NCT00085358|Drug|paclitaxel|Given IV or intraperitoneally
12065508|NCT00085358|Drug|docetaxel|Given IV
12065509|NCT00085358|Biological|bevacizumab|Given IV
12065510|NCT00085345|Drug|arsenic trioxide|
12065511|NCT00085345|Drug|ascorbic acid|
12065512|NCT00085345|Drug|melphalan|
12065513|NCT00085345|Procedure|chemosensitization/potentiation|
12065514|NCT00085345|Procedure|chemotherapy|
12065515|NCT00085332|Drug|docetaxel|
12065516|NCT00085306|Biological|recombinant interferon beta|recombinant interferon beta
12065517|NCT00085293|Drug|Decitabine|Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
12065518|NCT00085293|Radiation|Iodine I 131|Undergo thyrotropin-alfa stimulated radioactive iodine scan
12065519|NCT00085293|Biological|Recombinant thyrotropin alfa|Undergo thyrotropin-alfa stimulated radioactive iodine scan
12065520|NCT00085293|Radiation|Fludeoxyglucose F 18|Optional correlative studies
12065521|NCT00085293|Procedure|Positron emission tomography|Optional correlative studies
12065522|NCT00085280|Drug|erlotinib hydrochloride|Given orally
12065523|NCT00085280|Other|laboratory biomarker analysis|Correlative studies
12065524|NCT00085254|Drug|cilengitide|Given IV
12065525|NCT00085254|Drug|temozolomide|Given orally
12065526|NCT00085254|Radiation|radiation therapy|Undergo radiotherapy
12065527|NCT00085254|Other|laboratory biomarker analysis|Correlative studies
12065528|NCT00085254|Other|pharmacological study|Correlative studies
12065529|NCT00085228|Biological|oblimersen sodium|
12065530|NCT00085228|Drug|docetaxel|
12065531|NCT00085202|Biological|filgrastim|Given subcutaneously
12065532|NCT00085202|Drug|cisplatin|Given IV
12065533|NCT00085202|Drug|cyclophosphamide|Given IV
12065534|NCT00085202|Drug|vincristine|Given IV
12065535|NCT00085202|Procedure|autologous hematopoietic stem cell transplantation|Patients undergo autologous stem cell transplantation
12065536|NCT00085202|Radiation|radiation therapy|Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.
12065537|NCT00085189|Biological|gp100 antigen|Given SC
12065538|NCT00085189|Biological|tyrosinase peptide|Given SC
12065539|NCT00085189|Biological|recombinant MAGE-3.1 antigen|Given SC
12065540|NCT00085189|Biological|multi-epitope melanoma peptide vaccine|Given SC
12065541|NCT00085189|Biological|incomplete Freund's adjuvant|Given SC
12065542|NCT00085189|Drug|Montanide ISA 51 VG|Given SC
12065543|NCT00085189|Drug|agatolimod sodium|Given SC
12065544|NCT00085189|Other|laboratory biomarker analysis|Correlative studies
12065545|NCT00085176|Procedure|management of therapy complications|
12065546|NCT00085176|Procedure|psychosocial assessment and care|
12065547|NCT00085163|Drug|celecoxib|
12065548|NCT00085163|Drug|fluorouracil|
12065549|NCT00085163|Drug|leucovorin calcium|
12065550|NCT00085163|Procedure|adjuvant therapy|
12065551|NCT00085150|Biological|LMB-2 immunotoxin|
12065552|NCT00085124|Biological|oblimersen sodium|Given IV
12065553|NCT00085124|Drug|cytarabine|Given IV
12065554|NCT00085124|Drug|daunorubicin hydrochloride|Given IV
12065555|NCT00085124|Other|laboratory biomarker analysis|Correlative studies
12065556|NCT00085111|Biological|bevacizumab|Given IV
12065557|NCT00085098|Biological|filgrastim|Given by infusion or injection
12065558|NCT00085098|Drug|carboplatin|Given IV over 1 hour
12065559|NCT00085098|Drug|cisplatin|Given IV over 6 hours
12065560|NCT00085098|Drug|cyclophosphamide|Given IV over 1 hour
12065561|NCT00085098|Drug|etoposide|Given IV over 2 hours
12065562|NCT00085098|Radiation|radiation therapy|Patients undergo radiotherapy 5 days a week
12065563|NCT00085059|Drug|boronophenylalanine-fructose complex|
12065564|NCT00085020|Biological|trastuzumab|
12065565|NCT00085020|Drug|lapatinib ditosylate|
12065566|NCT00084981|Drug|decitabine|Given IV
12065567|NCT00084981|Drug|valproic acid|Given PO
12065568|NCT00084981|Other|pharmacological study|Correlative studies
12065569|NCT00084981|Other|laboratory biomarker analysis|Correlative studies
12065570|NCT00084942|Drug|capecitabine|
12065571|NCT00084942|Drug|gemcitabine hydrochloride|
12065572|NCT00084929|Procedure|CT Colonography|CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
12065573|NCT00084916|Drug|temsirolimus|Given IV
12065574|NCT00084916|Other|laboratory biomarker analysis|Correlative studies
12065575|NCT00084903|Procedure|Colposcopic biopsy|Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.
12065576|NCT00084903|Procedure|Light-Scattering Spectroscopy|Spectroscopy readings taken in 2 regions of cervix.
12065577|NCT00084890|Drug|carboplatin|30 minute infusion dosed based on glomerular filtration rate of patient
12065578|NCT00084890|Drug|docetaxel|escalating doses ofstarting at 25 milligrams per meter squared
12065579|NCT00084877|Drug|triapine|Given IV
12065580|NCT00084877|Drug|irinotecan hydrochloride|Given IV
12065581|NCT00084877|Other|laboratory biomarker analysis|Correlative studies
12065582|NCT00084877|Other|pharmacological study|Correlative studies
12065583|NCT00084864|Dietary Supplement|calcitriol|Given orally
12065584|NCT00084864|Drug|dexamethasone|Given orally
12065585|NCT00084864|Other|clinical observation|No intervention before surgery
12065586|NCT00084838|Biological|filgrastim|
12065587|NCT00084838|Drug|cisplatin|
12065588|NCT00084838|Drug|cyclophosphamide|
12065589|NCT00084838|Drug|cytarabine|
12065590|NCT00084838|Drug|dexrazoxane hydrochloride|
12065591|NCT00084838|Drug|doxorubicin hydrochloride|
12065592|NCT00084838|Drug|etoposide|
12065593|NCT00084838|Drug|leucovorin calcium|
12065594|NCT00084838|Drug|methotrexate|
12065595|NCT00084838|Drug|temozolomide|
12065596|NCT00084838|Drug|therapeutic hydrocortisone|
12065597|NCT00084838|Drug|vincristine sulfate|
12065598|NCT00084838|Radiation|radiation therapy|
12065599|NCT00084838|Drug|Dactinomycin|
12065600|NCT00084825|Drug|Docetaxel|30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 days
12065601|NCT00084825|Drug|Imatinib mesylate|600 mg orally daily
12065602|NCT00084812|Drug|cisplatin|
12065603|NCT00084812|Drug|safingol|
12065604|NCT00084799|Biological|monoclonal antibody Hu3S193|
12065605|NCT00084786|Drug|docetaxel|
12065606|NCT00084786|Drug|gefitinib|
12065607|NCT00084773|Biological|cetuximab|
12065608|NCT00084773|Drug|fluorouracil|
12065609|NCT00084773|Procedure|neoadjuvant therapy|
12065610|NCT00084773|Radiation|radiation therapy|
12065611|NCT00084747|Drug|bortezomib|
12065612|NCT00084734|Drug|capecitabine|Oral
12065613|NCT00084734|Drug|cisplatin|IV
12065614|NCT00084734|Drug|docetaxel|IV
12065615|NCT00084721|Drug|celecoxib|
12065616|NCT00084721|Drug|irinotecan hydrochloride|
12065617|NCT00084708|Dietary Supplement|calcitriol|
12065618|NCT00084708|Drug|dexamethasone|
12065619|NCT00084708|Drug|gefitinib|
12065620|NCT00084695|Biological|anti-thymocyte globulin|Given IV
12065621|NCT00084695|Drug|busulfan|Given orally
12065622|NCT00084695|Drug|cyclophosphamide|Given IV
12065623|NCT00084695|Drug|fludarabine phosphate|Given IV
12065624|NCT00084695|Drug|melphalan|Given IV
12065625|NCT00084695|Drug|methylprednisolone|Given IV
12065626|NCT00084695|Radiation|radiation therapy|Patients undergo radiation therapy two times daily on days -7 to -4.
12065627|NCT00084682|Drug|romidepsin|Given IV
12065628|NCT00084669|Drug|venlafaxine|
12065629|NCT00084669|Drug|zolpidem tartrate|
12065630|NCT00084669|Procedure|management of therapy complications|
12065631|NCT00084656|Biological|ipilimumab|IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II)
12065632|NCT00084656|Biological|Tyrosinase/gp100/MART-1 Peptides|(All subjects in Part I and HLA-A*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.)
12065633|NCT00084643|Biological|GTI-2040|Given IV
12065634|NCT00084643|Drug|oxaliplatin|Given IV
12065635|NCT00084643|Drug|capecitabine|Given orally
12065636|NCT00084643|Other|pharmacological study|Correlative studies
12065637|NCT00084643|Other|laboratory biomarker analysis|Correlative studies
12065638|NCT00084630|Drug|imatinib mesylate|Given orally
12065639|NCT00084630|Other|laboratory biomarker analysis|Correlative studies
12065640|NCT00084617|Drug|oxaliplatin|Given IV
12065641|NCT00084617|Drug|irinotecan hydrochloride|Given IV
12065642|NCT00084617|Drug|capecitabine|Given orally
12065643|NCT00084604|Drug|irinotecan hydrochloride|Given IV
12065644|NCT00084604|Biological|bevacizumab|Given IV
12065645|NCT00084604|Drug|cisplatin|Given IV
12065646|NCT00084604|Procedure|computed tomography|Correlative studies
12065647|NCT00084604|Other|laboratory biomarker analysis|Correlative studies
12065648|NCT00084591|Drug|capecitabine|
12065649|NCT00084591|Procedure|conventional surgery|
12066069|NCT00005942|Drug|semaxanib|Given IV
12065650|NCT00084591|Procedure|neoadjuvant therapy|
12065651|NCT00084591|Radiation|radiation therapy|
12065652|NCT00084578|Drug|celecoxib|
12065653|NCT00084578|Drug|rosiglitazone maleate|
12065654|NCT00084578|Procedure|conventional surgery|
12065655|NCT00084578|Procedure|neoadjuvant therapy|
12065656|NCT00084565|Drug|estramustine phosphate sodium|
12065657|NCT00084565|Drug|paclitaxel|
12065658|NCT00084565|Drug|topotecan hydrochloride|
12065659|NCT00084552|Radiation|radiation therapy|Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
12065660|NCT00084539|Radiation|Radiation therapy|
12065661|NCT00084526|Procedure|computed tomography|
12065662|NCT00084526|Procedure|ultrasound imaging|
12065663|NCT00084513|Biological|trastuzumab|
12065664|NCT00084513|Drug|imatinib mesylate|
12065665|NCT00084487|Drug|becatecarin|Given IV
12065666|NCT00084461|Drug|romidepsin|Given IV
12065667|NCT00084461|Other|laboratory biomarker analysis|Correlative studies
12065668|NCT00084448|Drug|celecoxib|
12065669|NCT00084448|Drug|paclitaxel|
12065670|NCT00084435|Drug|cisplatin|75 mg/m2 IV, Day 1, q 21 days for 3 cycles
12065671|NCT00084435|Drug|docetaxel|15 mg/m2 IV, Day 1, 1 7 days for 6 doses
12065672|NCT00084435|Radiation|radiation therapy|200 cGy/day, Days 1-5, q week for 6 weeks
12065673|NCT00084422|Drug|lestaurtinib|Given orally twice daily x 5 consecutive days followed by a two day rest. 28 days = 1 treatment course. Courses repeated indefinitely without gap provided patient has recovered course from toxicities and no DLTs. Dose level assigned according to the planned dose escalation schedule.
12065674|NCT00084409|Drug|iloprost|Given orally
12065675|NCT00084409|Other|placebo|Given orally
12065676|NCT00084396|Drug|letrozole|
12065677|NCT00084396|Procedure|conventional surgery|
12065678|NCT00084383|Biological|GVAX pancreatic cancer vaccine|"Patients will receive vaccinations consisting of 5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy (chemo-radiation therapy is standard of care and not part of the protocol) eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth booster vaccination, six months following the fourth vaccination."
12065679|NCT00084370|Drug|celecoxib|Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
12065680|NCT00084370|Procedure|oophorectomy|
12065681|NCT00084344|Drug|4-hydroxytamoxifen|
12065682|NCT00084344|Procedure|breast imaging study|
12065683|NCT00084344|Procedure|radiomammography|
12065684|NCT00084318|Biological|cetuximab|400 mg/m^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m^2 intravenously over 60 minutes in weeks 2 through 7.
12065685|NCT00084318|Drug|cisplatin|30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.
12065686|NCT00084318|Drug|docetaxel|15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.
12065687|NCT00084318|Radiation|radiation therapy|60 Gy (2 Gy once a day, 5 times a week)
12065688|NCT00084279|Drug|Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin|interferon gamma-1b: 0.25 and 0.5 mL, SQ, 3x per week interferon alfacon: 0.3 mL and 0.5 mL, SQ, once a day Ribavirin: 2 capsules in a.m., 3 capsules in p.m.; daily
12065689|NCT00084266|Drug|linezolid (Zyvox)|Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
12065690|NCT00084266|Drug|vancomycin|Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
12065691|NCT00084253|Drug|Atazanavir/ Stavidine / Lamivudine|Capsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks.
12065692|NCT00084253|Drug|Atazanavir-Ritonavir/ Stavidine / Lamivudine|Capsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD*, Once daily, 96 weeks.
12065693|NCT00084240|Drug|Azithromycin/Chloroquine|
12065694|NCT00084240|Drug|Sulfadoxine-Pyrimethamine/Chloroquine|
12065695|NCT00084227|Drug|Azithromycin/Chloroquine|
12065696|NCT00084227|Drug|Atovaquone/Proguanil|
12065697|NCT00084214|Drug|STA-4783|
12065698|NCT00084214|Drug|Paclitaxel|
12065699|NCT00002682|Drug|Amoxicillin|
12065700|NCT00002682|Drug|Bismuth Subsalicylate|
12065701|NCT00002682|Drug|Clarithromycin|
12065702|NCT00002682|Drug|Metronidazole Hydrochloride|
12065703|NCT00002682|Drug|Omeprazole|
12065704|NCT00002682|Drug|Tetracycline Hydrochloride|
12065705|NCT00002676|Drug|carmustine|
12065706|NCT00002676|Drug|cyclophosphamide|
12065707|NCT00002676|Drug|cytarabine|
12065708|NCT00002676|Drug|dexamethasone|
12065709|NCT00002676|Drug|doxorubicin hydrochloride|
12065710|NCT00002676|Drug|methotrexate|
12065711|NCT00002676|Drug|vincristine sulfate|
12065712|NCT00002676|Radiation|low-LET cobalt-60 gamma ray therapy|
12065713|NCT00002676|Radiation|low-LET photon therapy|
12065714|NCT00002670|Drug|chemotherapy|
12065715|NCT00002670|Drug|cisplatin|
12065716|NCT00002670|Radiation|low-LET cobalt-60 gamma ray therapy|
12065717|NCT00002670|Radiation|low-LET electron therapy|
12065718|NCT00002670|Radiation|low-LET photon therapy|
12065719|NCT00002656|Drug|pyrazoloacridine|"Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity.
~Depending on the prior cycle toxicity the dose should be escalated, maintained or reduced, utilizing levels: -1, 0 (initial dose level), 1 - Level +1 (820mg/m2); Level 0 (750mg/m2); Level -1 (600mg/m2)"
12065720|NCT00002646|Drug|fenretinide|
12065721|NCT00002646|Drug|tamoxifen citrate|
12065722|NCT00002637|Biological|aldesleukin|
12065723|NCT00002637|Biological|gene-modified tumor cell vaccine therapy|
12065724|NCT00002637|Biological|recombinant interferon gamma|
12065725|NCT00002632|Drug|paclitaxel|
12065726|NCT00002625|Drug|topotecan hydrochloride|
12065727|NCT00002625|Radiation|low-LET electron therapy|
12065728|NCT00002625|Radiation|low-LET photon therapy|
12065729|NCT00002551|Drug|fluorouracil|See arm assignments.
12065730|NCT00002551|Drug|leucovorin calcium|See arm assignments.
12065731|NCT00002551|Drug|levamisole hydrochloride|See arm assignments.
12065732|NCT00002551|Radiation|radiation therapy|See arm assignments.
12065733|NCT00002538|Procedure|laparoscopic surgery|
12065734|NCT00084201|Drug|Cranberry juice|
12065735|NCT00084201|Drug|Amoxicillin|
12065736|NCT00084188|Behavioral|Behavior Therapy|
12065737|NCT00084175|Behavioral|Behavior Therapy|
12065738|NCT00006451|Drug|anti-thymocyte globulin|
12065739|NCT00006451|Drug|cyclophosphamide|
12065740|NCT00006451|Drug|cyclosporine|
12065741|NCT00006451|Drug|methotrexate|
12065742|NCT00006451|Drug|methylprednisolone|
12065743|NCT00006451|Procedure|allogeneic bone marrow transplantation|
12065744|NCT00006451|Procedure|in vitro-treated bone marrow transplantation|
12065745|NCT00006451|Procedure|radiation therapy|
12065746|NCT00006387|Biological|QS21|
12065747|NCT00006387|Biological|ras peptide cancer vaccine|
12065748|NCT00006382|Procedure|bronchoscopic and lung imaging studies|
12065749|NCT00006382|Procedure|comparison of screening methods|
12065750|NCT00006382|Procedure|computed tomography|
12065751|NCT00006382|Procedure|radiography|
12065752|NCT00006382|Procedure|study of high risk factors|
12065753|NCT00006380|Biological|monoclonal antibody muJ591|
12065754|NCT00006380|Radiation|iodine I 131 monoclonal antibody muJ591|
12065755|NCT00006378|Drug|carboplatin|
12065756|NCT00006378|Drug|paclitaxel|
12065757|NCT00006378|Radiation|radiation therapy|
12065758|NCT00006374|Biological|filgrastim|
12065759|NCT00006374|Drug|cisplatin|
12065760|NCT00006374|Drug|etoposide|
12065761|NCT00006374|Drug|paclitaxel|
12065762|NCT00006374|Drug|topotecan hydrochloride|
12065763|NCT00006251|Radiation|total-body irradiation|Undergo TBI
12065764|NCT00006251|Drug|fludarabine phosphate|Given IV
12065765|NCT00006251|Drug|cyclosporine|Given PO
12065766|NCT00006251|Drug|mycophenolate mofetil|Given PO
12065767|NCT00006251|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC transplant
12065768|NCT00006251|Biological|donor lymphocytes|Undergo DLI
12065769|NCT00006251|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplant
12065770|NCT00006251|Other|laboratory biomarker analysis|Correlative studies
12065771|NCT00005994|Drug|ondansetron|
12065772|NCT00005790|Other|laboratory biomarker analysis|
12065773|NCT00005790|Procedure|biopsy|
12065774|NCT00005790|Procedure|magnetic resonance imaging|
12065775|NCT00005790|Radiation|gadopentetate dimeglumine|
12065776|NCT00005084|Procedure|conventional surgery|
12065777|NCT00005084|Procedure|magnetic resonance spectroscopic imaging|
12065778|NCT00005084|Radiation|radiation therapy|
12065779|NCT00005045|Drug|carboxyamidotriazole|
12065780|NCT00004236|Drug|pegylated liposomal doxorubicin hydrochloride|
12065781|NCT00003992|Biological|trastuzumab|
12065782|NCT00003992|Drug|cyclophosphamide|
12065783|NCT00003992|Drug|doxorubicin hydrochloride|
12065784|NCT00003992|Drug|paclitaxel|
12065785|NCT00003992|Drug|tamoxifen citrate|
12065786|NCT00003859|Drug|carboplatin|
12065787|NCT00003859|Drug|cyclophosphamide|
12065788|NCT00003859|Drug|etoposide|
12065789|NCT00003859|Drug|vincristine sulfate|
12065790|NCT00003859|Procedure|surgical procedure|
12065791|NCT00003859|Radiation|radiation therapy|
12065792|NCT00003733|Drug|carboplatin|
12065793|NCT00003733|Drug|paclitaxel|
12065794|NCT00003733|Drug|topotecan hydrochloride|
12065795|NCT00003584|Drug|estramustine phosphate sodium|
12065796|NCT00003584|Drug|prednisone|
12065797|NCT00003584|Drug|vinorelbine tartrate|
12065798|NCT00003435|Biological|anti-thymocyte globulin|
12065799|NCT00003435|Drug|melphalan|
12065800|NCT00003435|Procedure|antiviral therapy|
12065801|NCT00003435|Procedure|bone marrow ablation with stem cell support|
12065802|NCT00003435|Procedure|peripheral blood stem cell transplantation|
12065803|NCT00003435|Procedure|umbilical cord blood transplantation|
12065804|NCT00003435|Radiation|radiation therapy|
12065805|NCT00003410|Drug|motexafin gadolinium|
12065806|NCT00003410|Procedure|magnetic resonance imaging|
12065807|NCT00003410|Procedure|surgical procedure|
12065808|NCT00003372|Drug|topotecan hydrochloride|
12065809|NCT00003236|Biological|ISIS 3521|
12065810|NCT00003236|Drug|ISIS 5132|
12065811|NCT00002905|Drug|cyclophosphamide|
12065812|NCT00002905|Drug|didanosine|
12065813|NCT00002905|Drug|doxorubicin hydrochloride|
12065814|NCT00002905|Drug|etoposide|
12065815|NCT00002905|Drug|mitoxantrone hydrochloride|
12065816|NCT00002905|Drug|prednimustine|
12065817|NCT00002905|Drug|zidovudine|
12065818|NCT00002496|Drug|chemotherapy|
12065819|NCT00002496|Drug|cisplatin|
12065820|NCT00002496|Drug|fluorouracil|
12065821|NCT00002496|Procedure|conventional surgery|
12065822|NCT00002496|Radiation|low-LET cobalt-60 gamma ray therapy|
12065823|NCT00002496|Radiation|low-LET electron therapy|
12065824|NCT00002496|Radiation|low-LET photon therapy|
12065825|NCT00002478|Drug|etoposide|
12065826|NCT00002476|Biological|bleomycin sulfate|
12065827|NCT00002476|Drug|fluorouracil|
12065828|NCT00002476|Drug|leucovorin calcium|
12065830|NCT00002476|Drug|vincristine sulfate|
12065831|NCT00002476|Radiation|low-LET cobalt-60 gamma ray therapy|
12065832|NCT00002476|Radiation|low-LET photon therapy|
12065833|NCT00002476|Radiation|radiation therapy|
12065834|NCT00002460|Drug|goserelin acetate|
12065835|NCT00002460|Drug|tamoxifen citrate|
12065836|NCT00002460|Procedure|ablative endocrine surgery|
12065837|NCT00002460|Procedure|oophorectomy|
12065838|NCT00084149|Drug|Abacavir sulfate, Lamivudine, and Zidovudine|antiretroviral therapy
12065839|NCT00084149|Drug|Lopinavir/Ritonavir|antiretroviral therapy
12065840|NCT00084136|Drug|Atazanavir|400 mg taken orally daily
12065841|NCT00084136|Drug|Didanosine (enteric-coated)|400 mg taken orally daily
12065842|NCT00084136|Drug|Efavirenz|600 mg taken orally daily
12065843|NCT00084136|Drug|Emtricitabine|200 mg taken orally daily
12065844|NCT00084136|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg/300 mg taken orally once daily
12065845|NCT00084136|Drug|Lamivudine/Zidovudine|150 mg/300 mg taken orally twice daily
12065846|NCT00084123|Behavioral|Healing Touch Therapy|
12065847|NCT00084123|Behavioral|Relaxation Therapy|
12065848|NCT00084123|Behavioral|Standard Care|Standard Care
12065849|NCT00084071|Drug|Tifacogin|
12065850|NCT00083993|Drug|Temsirolimus (CCI-779) for 34 months|
12065851|NCT00083993|Drug|Letrozole for 34 months|
12065852|NCT00005960|Biological|filgrastim|
12065853|NCT00005960|Drug|cyclophosphamide|
12065854|NCT00005960|Drug|docetaxel|
12065855|NCT00005960|Drug|doxorubicin hydrochloride|
12065856|NCT00005960|Procedure|pain therapy|
12065857|NCT00005641|Biological|anti-thymocyte globulin|
12065858|NCT00005641|Drug|busulfan|
12065859|NCT00005641|Drug|cyclophosphamide|
12065860|NCT00005641|Drug|cyclosporine|
12065861|NCT00005641|Drug|leucovorin calcium|
12065862|NCT00005641|Drug|methotrexate|
12065863|NCT00005641|Drug|methylprednisolone|
12065864|NCT00005641|Procedure|allogeneic bone marrow transplantation|
12065865|NCT00005641|Procedure|in vitro-treated bone marrow transplantation|
12065866|NCT00005641|Radiation|radiation therapy|
12065867|NCT00005091|Drug|exatecan mesylate|
12065868|NCT00005054|Drug|temozolomide|
12065869|NCT00005050|Drug|ethynyluracil|
12065870|NCT00005050|Drug|fluorouracil|
12065871|NCT00005050|Drug|oxaliplatin|
12065872|NCT00084097|Drug|Omalizumab|
12065873|NCT00084084|Drug|Agalsidase alfa|0.2 mg/kg agalsidase alfa administered by IV infusion over 40 (+/- 10) minutes every other week for 52 weeks, with periodic reassessments for study continuation beyond 52 weeks
12065874|NCT00084058|Drug|Lopinavir/ritonavir|
12065875|NCT00084058|Drug|Saquinavir|
12065876|NCT00084045|Procedure|Intrapartum HIV counseling/testing|
12065877|NCT00084045|Procedure|Postpartum HIV counseling/testing|
12065878|NCT00084032|Behavioral|Structured treatment interruption|Treatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2
12065879|NCT00084032|Drug|Antiretroviral regimen|Participants will take any combination of FDA-approved ARV medications prescribed by their physician
12065880|NCT00084019|Drug|Atazanavir|
12065881|NCT00084019|Drug|Ritonavir|
12065882|NCT00083980|Drug|Venlafaxine ER|75 to 225 mg daily
12065883|NCT00083980|Drug|Sugar pill|Upto 3 per day for venlafainxe and 4 per day for kava placebos.
12065884|NCT00083980|Drug|Kava|140 to 280 mg per day
12065885|NCT00083967|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
12065886|NCT00083954|Drug|Quetiapine Fumarate|
12065887|NCT00083941|Biological|TroVax|1ml intramuscular injection
12065888|NCT00083941|Biological|Interleukin-2|Intravenous IL-2
12065889|NCT00083928|Drug|Å6 subcutaneous injection|
12065890|NCT00083915|Drug|Cisplatin|20mg/m2 continuous infusion days -3 and -2.
12065891|NCT00083915|Drug|Cyclophosphamide|800 mg/m2 continuous infusion days -3 and -2.
12065892|NCT00083915|Drug|Adriamycin|20mg/m2 continuous infusion -3 and -2.
12065893|NCT00083915|Drug|Etoposide|80mg/m2 continuous infusion -3 and -2.
12065894|NCT00083915|Drug|Melphalan|200 mg/m2 IV over <20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
12065895|NCT00083915|Drug|Thalidomide|200mg PO Continuing to Day +5, then hold until platelets >50 thousand (K).
12065896|NCT00083915|Drug|Dexamethasone|40 mg po days 1 - 4 (4 days)
12065897|NCT00083902|Drug|Thalidomide|
12065898|NCT00083902|Drug|Dexamethasone|
12065899|NCT00083889|Drug|Interferon-alfa|3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
12065900|NCT00083889|Drug|SU011248|50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
12065901|NCT00083876|Drug|Thalidomide|
12065902|NCT00083824|Drug|Estrogens, Conjugated (USP)|0.625 mg/day QID for 3 years
12065903|NCT00083824|Drug|Medroxyprogesterone 17-Acetate|2.5 mg/day QID for 3 years
12065904|NCT00083824|Drug|Placebo|2 pills/day QID for 3 years
12065905|NCT00005032|Biological|oblimersen sodium|
12065906|NCT00005032|Drug|paclitaxel|
12065907|NCT00005030|Drug|SCH 66336|
12065908|NCT00005030|Procedure|conventional surgery|Exploratory laparotomy and/or resection of hepatic metastases. Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization. Other patients undergo surgery on days 8-15.
12065909|NCT00004979|Drug|paclitaxel|
12065910|NCT00004979|Drug|topotecan hydrochloride|
12065911|NCT00004927|Drug|ixabepilone|
12065912|NCT00004877|Drug|BMS-214662|
12065913|NCT00004161|Drug|fenretinide|
12065914|NCT00004161|Drug|Placebo|
12065915|NCT00004146|Radiation|radiation therapy|Undergo radiotherapy
12065916|NCT00004146|Drug|carboxyamidotriazole|Given orally
12065917|NCT00004146|Other|pharmacological study|Correlative studies
12065919|NCT00004071|Drug|mitoxantrone hydrochloride|
12065920|NCT00004071|Drug|prednisone|
12065921|NCT00004070|Biological|IL-12|
12065922|NCT00004062|Drug|azacitidine|
12065923|NCT00004062|Drug|liothyronine sodium|
12065924|NCT00004062|Radiation|iodine I 131|
12065925|NCT00083785|Drug|Talaporfin sodium (LS11)|
12065926|NCT00083785|Device|LED-based light infusion device|
12065927|NCT00083785|Device|Light emitting diodes (LED)|
12065928|NCT00083785|Procedure|Photodynamic therapy|
12065929|NCT00083785|Procedure|Phototherapy|
12065930|NCT00083785|Procedure|Chemotherapy|
12065931|NCT00083772|Drug|Nesiritide|Initial dose by vein of 2 mcg/kg then infusion by vein of 0.01 mcg/kg/min continuously for 48 hours.
12065932|NCT00083759|Drug|natalizumab|
12065933|NCT00083759|Drug|placebo|
12065934|NCT00004055|Biological|filgrastim|
12065935|NCT00004055|Drug|paclitaxel|
12065936|NCT00004055|Drug|topotecan hydrochloride|
12065937|NCT00003998|Drug|carboplatin|
12065938|NCT00003998|Drug|docetaxel|
12065939|NCT00003998|Drug|paclitaxel|
12065940|NCT00003998|Procedure|surgical procedure|
12065941|NCT00003997|Drug|irofulven|
12065942|NCT00003991|Biological|aldesleukin|
12065943|NCT00003991|Drug|histamine dihydrochloride|
12065944|NCT00003939|Drug|trabectedin|
12065945|NCT00003856|Drug|temoporfin|
12065946|NCT00003850|Drug|thalidomide|
12065947|NCT00003787|Behavioral|educational/counseling intervention|
12065948|NCT00003787|Behavioral|therapeutic dietary intervention|
12065949|NCT00003773|Drug|oglufanide disodium|
12065950|NCT00003758|Drug|cytarabine|
12065951|NCT00003758|Drug|idarubicin|
12065952|NCT00003758|Procedure|allogeneic bone marrow transplantation|
12065953|NCT00003758|Procedure|autologous bone marrow transplantation|
12065954|NCT00003758|Procedure|peripheral blood stem cell transplantation|
12065955|NCT00003755|Drug|MKC-1|
12065956|NCT00003740|Biological|trastuzumab|
12065957|NCT00003443|Drug|bryostatin 1|
12065958|NCT00003401|Drug|carmustine|
12065959|NCT00003401|Drug|cisplatin|
12065960|NCT00003401|Drug|cyclophosphamide|
12065961|NCT00003401|Drug|dexamethasone|
12065962|NCT00003401|Drug|etoposide|
12065963|NCT00003401|Drug|gemcitabine hydrochloride|
12065964|NCT00003401|Drug|melphalan|
12065965|NCT00003401|Drug|paclitaxel|
12065966|NCT00003401|Procedure|bone marrow ablation with stem cell support|
12065967|NCT00003401|Procedure|peripheral blood stem cell transplantation|
12065968|NCT00003399|Drug|carmustine|
12065969|NCT00003399|Drug|cisplatin|
12065970|NCT00003399|Drug|cyclophosphamide|
12065971|NCT00003399|Drug|dexamethasone|
12065972|NCT00003399|Drug|etoposide|
12065973|NCT00003399|Drug|melphalan|
12065974|NCT00003399|Drug|paclitaxel|
12065975|NCT00003399|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12065976|NCT00003396|Biological|anti-thymocyte globulin|
12065977|NCT00003396|Biological|graft-versus-tumor induction therapy|
12065978|NCT00003396|Drug|cyclophosphamide|
12065979|NCT00003396|Drug|melphalan|
12065980|NCT00003396|Procedure|peripheral blood stem cell transplantation|
12065981|NCT00003396|Radiation|radiation therapy|
12065982|NCT00003293|Drug|leflunomide|
12065983|NCT00003293|Drug|procarbazine hydrochloride|
12065984|NCT00003249|Drug|carboxyamidotriazole|
12065985|NCT00003249|Drug|chemotherapy|
12065986|NCT00003249|Drug|ketoconazole|
12065987|NCT00003231|Drug|cisplatin|
12065988|NCT00003231|Drug|docetaxel|
12065989|NCT00003231|Procedure|surgical procedure|
12065990|NCT00003231|Radiation|radiation therapy|
12065991|NCT00083720|Biological|cetuximab|Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
12065992|NCT00083707|Drug|Thalidomide|
12065993|NCT00083694|Drug|Thalidomide|
12065994|NCT00083681|Drug|Thalidomide|
12065995|NCT00083681|Drug|Dexamethasone|
12065996|NCT00083681|Drug|Cytoxan|
12065997|NCT00083681|Drug|Etoposide|
12065998|NCT00083681|Drug|Cisplatin|
12065999|NCT00083681|Drug|G-CSF|
12066000|NCT00083668|Drug|Paliperidone ER|
12066001|NCT00083616|Biological|Panitumumab|Panitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion.
12066002|NCT00083564|Drug|STR(TM) (Skeletal Targeted Radiotherapy, Holmium-166-DOTMP)|
12066003|NCT00083629|Procedure|PET|
12066004|NCT00083603|Biological|rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)|rMVA 10^7 pfu /2mL administered in each deltoid
12066005|NCT00083603|Biological|rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)|Vaccines administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid
12066006|NCT00083603|Biological|Empty TBC-FPV|Empty FPV 10^9 pfu/2mL administered as two separate 1 mL intramuscular injections, one into each deltoid.
12066007|NCT00083603|Biological|rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)|rMVA 10^8 pfu /2mL administered in each deltoid
12066008|NCT00083603|Biological|rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)|rMVA 10^9 pfu /2mL administered in each deltoid
12066009|NCT00083603|Biological|TBC-MVA and TBC-FPV|Empty MVA 10^7 pfu/2mL administered into each deltoid
12066010|NCT00083603|Biological|TBC-MVA and TBC-FPV|Empty MVA 10^8 pfu/2mL administered into each deltoid
12066011|NCT00083603|Biological|TBC-MVA and TBC-FPV|Empty MVA 10^9 pfu/2mL administered into each deltoid
12066012|NCT00083590|Drug|Huperzine A|
12066013|NCT00083577|Drug|Thalidomide|
12066070|NCT00005942|Other|laboratory biomarker analysis|Correlative studies
12066071|NCT00005939|Radiation|brachytherapy|
12066072|NCT00005939|Radiation|phosphorus P32|
12066014|NCT00083551|Drug|Thalidomide|All patients will be randomly assigned to receive thalidomide 400 mg as an oral, once daily dose throughout induction and 100mg between transplants after platelets are greater than 50,000μl and 200 mg post transplant consolidation, and a reduced dose of 100 mg on alternating days during the first year of maintenance and 50 mg qod thereafter versus no thalidomide. Thalidomide will be held during conditioning, transplant procedure, and recovery following transplant. It may be resumed once plateletrecovery is complete after each transplant
12066015|NCT00083551|Drug|Ara-C|"Cytarabine (Ara-C) 400 mg/m2 in 250 ml D5W over one hour daily for four days (on days -5, -4, -3, -2).
~Start infusion 30 minutes after completion of BCNU on day -5."
12066016|NCT00083551|Drug|BCNU|Carmustine (BCNU) 300 mg/m2 in 1 liter of D5W in glass bottle (protect from light) to infuse over 2 hours on day -5. Check blood pressure every 15 minutes during infusion and 30 minutes after completion
12066017|NCT00083551|Drug|Cisplatin|"Cisplatin* 15 mg/m2/day Continuous infusion 1-4 (DCEP CYCLE 2) Cisplatin* 7.5 mg/m2 Continuous infusion 1-4 (DPACE cycle)
~*Cisplatin doses will be modified for renal insufficiency as follows: Cisplatin dose Creatinine 15 mg/m2 (full dose) < 1.5 mg/dl 10 mg/m2 1.6 - 2.0 mg/dl 7.5 mg/m2 2.1 - 3.0 mg/dl 0 mg (hold Cisplatin) > 3.0 mg/dl"
12066018|NCT00083551|Drug|Cytoxan|Cycle 2 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cycle 3 - CAD and PBSC Collection #1 Cyclophosphamide 750 mg/m2/day Continuous infusion 1-4 Cycle 4 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cytoxan/VP-16 and PBSC Collection-Cyclophosphamide 2 grams/m2 (Total dose 4 gm/m2) IV by CI 1 and 2 Post-Transplant Consolidation-Cyclophosphamide 300 mg/m2 Continuous infusion 1-4
12066019|NCT00083551|Drug|Dexamethasone|Induction cycle 1 VAD Dexamethasone 40 mg/day PO 1-4, 9-12, 17-20 Cycle 2 - DCEP Dexamethasone 40 mg/day PO 1-4 Cycle 3 - CAD and PBSC Collection #1 Dexamethasone 40 mg/day PO 1-4 Cycle 4 - DCEP and PBSC Collection #2 Dexamethasone 40 mg/day PO 1-4 Post-Transplant Consolidation Dexamethasone 40 mg PO 1-4 Dexamethasone Consolidation Patients that do not achieve adequate platelet recovery (defined as < 80,000/μl) will receive consolidation with Dexamethasone 40 mg x 4 days every 28 days for 1 year Maintenance year one Dexamethasone 40 mg PO q 3 months, day 1-4, 9-12, 17-20
12066020|NCT00083551|Drug|Doxorubicin|Doxorubicin may be further diluted in 5% dextrose or sodium chloride injection and should be administered slowly into tubing of a freely flowing intravenous infusion with great care taken to avoid extravasation.
12066021|NCT00083551|Drug|Etoposide|Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
12066022|NCT00083551|Drug|Filgrastim|G-CSF will be administered at a dose of 10mcg/kg or GM-CSF at a dose of 10 mcg/kg. G-CSF or GM-CSF will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
12066023|NCT00083551|Drug|Recombinant GM-CSF|GM-CSF at a dose of 10 μg/kg SC, divided in 2 doses each day, will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
12066024|NCT00083551|Drug|Interferon-alpha-2b|AGENT DOSE ROUTE DAYS Intron-A 3 million units/m2 SQ TIW Thalidomide (for those randomized at initial registration) 50 mg QOD PO Every other day (qod
12066025|NCT00083551|Drug|Melphalan|Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
12066026|NCT00083551|Drug|Vincristine|Formulation: 1 mg/1 ml, 2 mg/2 ml, and 5 mg/ 5 ml vials. Vincristine should be administered intravenously through a freely-running IV. If it extravasates, it produces a severe local reaction with skin slough. FATAL IF GIVEN INTRATHECALLY, FOR INTRAVENOUS USE ONLY.
12066027|NCT00083538|Drug|Dexamethasone|
12066028|NCT00083538|Drug|Thalidomide|
12066029|NCT00083538|Drug|Cisplatinum|
12066030|NCT00083538|Drug|Adriamycin|
12066031|NCT00083538|Drug|Cyclophosphamide|
12066032|NCT00083538|Drug|Etoposide|
12066033|NCT00083486|Drug|epoetin alfa|
12066034|NCT00003160|Drug|paclitaxel|
12066035|NCT00003079|Drug|bryostatin 1|
12066036|NCT00003079|Drug|cytarabine|
12066037|NCT00003075|Drug|Fenretinide|Oral Fenretinide daily for 6 months with 3 days of rest every month.
12066038|NCT00003075|Other|Placebo|Oral placebo daily for 6 months with 3 days of rest every month.
12066039|NCT00003031|Drug|amphotericin B deoxycholate|
12066040|NCT00003031|Drug|voriconazole|
12066041|NCT00003015|Drug|carboplatin|
12066042|NCT00003015|Drug|vincristine sulfate|
12066043|NCT00003015|Procedure|conventional surgery|
12066044|NCT00003015|Radiation|radiation therapy|
12066045|NCT00083525|Drug|WX-UK1 in combination with Capecitabine|
12066046|NCT00083473|Drug|Pivanex|
12066047|NCT00083460|Drug|PS-341|Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
12066048|NCT00083460|Drug|Thalidomide|In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
12066049|NCT00083460|Drug|Dexamethasone|A dose of 20mg for cylces 3-8.
12066050|NCT00083447|Drug|TransMID™|
12066051|NCT00083434|Drug|Epoetin alfa|
12066052|NCT00006877|Drug|temozolomide|
12066053|NCT00006358|Drug|temozolomide|
12066054|NCT00006358|Drug|thalidomide|
12066055|NCT00006343|Biological|recombinant interferon alfa|
12066056|NCT00006343|Drug|cytarabine|
12066057|NCT00006343|Drug|imatinib mesylate|
12066058|NCT00006222|Drug|cilengitide|
12066059|NCT00006212|Drug|cisplatin|
12066060|NCT00006212|Drug|vinblastine sulfate|
12066061|NCT00006212|Radiation|phosphorus P32|
12066062|NCT00006212|Radiation|radiation therapy|
12066063|NCT00006083|Drug|Fragmin|Fragmin at 5000 IU injected subcutaneously daily
12066064|NCT00006083|Other|placebo|placebo injected subcutaneously daily
12066065|NCT00006079|Drug|Eflornithine|Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
12066066|NCT00006079|Other|Placebo|Patients receive oral placebo daily for 28 days.
12066067|NCT00006001|Drug|semaxanib|
12066068|NCT00005942|Drug|liposomal daunorubicin citrate|Given IV
12066073|NCT00005841|Biological|MART-1 antigen|
12066074|NCT00005841|Biological|gp100 antigen|
12066075|NCT00005841|Biological|incomplete Freund's adjuvant|
12066076|NCT00005841|Biological|progenipoietin|
12066077|NCT00005841|Biological|tyrosinase peptide|
12066078|NCT00005645|Drug|ILX-295501|
12066079|NCT00005640|Procedure|Preoperative Endoscopy|
12066080|NCT00005640|Radiation|Technetium Tc 99m Sulfur Colloid|
12066081|NCT00005640|Procedure|Gamma Probe|
12066082|NCT00005640|Procedure|Biopsy of Sentinel Lymph Nodes|
12066083|NCT00005636|Drug|cisplatin|
12066084|NCT00005636|Drug|pemetrexed disodium|
12066085|NCT00005578|Biological|bleomycin sulfate|
12066086|NCT00005578|Biological|filgrastim|
12066087|NCT00005578|Drug|cyclophosphamide|
12066088|NCT00005578|Drug|dexrazoxane hydrochloride|
12066089|NCT00005578|Drug|doxorubicin hydrochloride|
12066090|NCT00005578|Drug|etoposide|
12066091|NCT00005578|Drug|prednisone|
12066092|NCT00005578|Drug|vincristine sulfate|
12066093|NCT00005578|Radiation|radiation therapy|
12066094|NCT00005088|Drug|cisplatin|
12066095|NCT00005088|Radiation|radiation therapy|
12066096|NCT00005069|Drug|arsenic trioxide|
12066097|NCT00005059|Drug|carboplatin|
12066098|NCT00005059|Drug|paclitaxel|
12066099|NCT00002923|Drug|KRN5500|
12066100|NCT00002917|Drug|paclitaxel|
12066101|NCT00002911|Drug|marimastat|
12066102|NCT00002829|Biological|Recombinant Interferon Alfa|Daily
12066103|NCT00002829|Drug|Cyclophosphamide|Infused intravenously over 2 hours daily on Day -7 and -6.
12066104|NCT00002829|Drug|Etoposide|Administered intravenously on Day -8
12066105|NCT00002829|Drug|Mesna|Beginning 1 hour after initiation of the cyclophosphamide treatment.
12066106|NCT00002829|Procedure|Bone Marrow Transplantation|Infusion on Day 0.
12066107|NCT00002829|Radiation|Radiation Therapy|Total body irradiation is received on days -4, -3, -2 , and -1.
12066108|NCT00002827|Biological|bleomycin sulfate|Given IV
12066109|NCT00002827|Biological|filgrastim|Given IV
12066110|NCT00002827|Drug|dexrazoxane hydrochloride|Given IV
12066111|NCT00002827|Drug|doxorubicin hydrochloride|Given IV
12066112|NCT00002827|Drug|etoposide|Given IV
12066113|NCT00002827|Drug|vincristine sulfate|Given IV
12066114|NCT00002827|Radiation|low-LET cobalt-60 gamma ray therapy|
12066115|NCT00002827|Radiation|low-LET electron therapy|
12066116|NCT00002827|Radiation|low-LET photon therapy|
12066117|NCT00002819|Drug|carboplatin|
12066118|NCT00002819|Drug|cyclophosphamide|
12066119|NCT00002819|Drug|mitoxantrone hydrochloride|
12066120|NCT00002819|Drug|paclitaxel|
12066121|NCT00002819|Procedure|autologous bone marrow transplantation|
12066122|NCT00002819|Procedure|peripheral blood stem cell transplantation|
12066123|NCT00002806|Drug|lomustine|
12066124|NCT00002806|Drug|procarbazine hydrochloride|
12066125|NCT00002806|Drug|vincristine sulfate|
12066126|NCT00002806|Radiation|low-LET photon therapy|
12066127|NCT00002721|Drug|doxorubicin hydrochloride|
12066128|NCT00002721|Drug|estramustine phosphate sodium|
12066129|NCT00002721|Procedure|drug resistance inhibition treatment|
12066130|NCT00002639|Drug|chemotherapy|
12066131|NCT00002639|Drug|suramin|
12066132|NCT00002602|Radiation|3D-CRT|3 dimensional conformal radiation therapy
12066133|NCT00002555|Drug|cisplatin|
12066134|NCT00002555|Radiation|low-LET cobalt-60 gamma ray therapy|
12066135|NCT00002555|Radiation|low-LET electron therapy|
12066136|NCT00002555|Radiation|low-LET photon therapy|
12066137|NCT00002477|Drug|carboplatin|
12066138|NCT00002477|Drug|cisplatin|
12066139|NCT00002477|Drug|cyclophosphamide|
12066140|NCT00002477|Drug|doxorubicin hydrochloride|
12066141|NCT00083408|Drug|Pamidronate|
12066142|NCT00083408|Drug|Thalidomide|
12066143|NCT00004881|Biological|MVA-MUC1-IL2 vaccine|
12066144|NCT00004200|Drug|prinomastat|
12066145|NCT00004200|Drug|temozolomide|
12066146|NCT00004190|Drug|gemcitabine hydrochloride|
12066147|NCT00004190|Drug|oxaliplatin|
12066148|NCT00004176|Drug|amifostine trihydrate|
12066149|NCT00004176|Drug|cisplatin|
12066150|NCT00004176|Drug|etoposide|
12066151|NCT00004176|Radiation|radiation therapy|
12066152|NCT00004139|Drug|docetaxel|
12066153|NCT00004139|Drug|gemcitabine hydrochloride|
12066154|NCT00004139|Drug|irinotecan hydrochloride|
12066155|NCT00004112|Biological|rituximab|
12066156|NCT00004112|Drug|CHOP regimen|
12066157|NCT00004112|Drug|cyclophosphamide|
12066158|NCT00004112|Drug|doxorubicin hydrochloride|
12066159|NCT00004112|Drug|prednisone|
12066160|NCT00004112|Drug|vincristine sulfate|
12066161|NCT00004105|Drug|estramustine phosphate sodium|
12066162|NCT00004105|Drug|paclitaxel|
12066163|NCT00004105|Drug|vinorelbine ditartrate|
12066164|NCT00004061|Biological|filgrastim|
12066165|NCT00004061|Biological|palifermin|
12066166|NCT00004061|Drug|cyclophosphamide|
12066167|NCT00004061|Drug|etoposide|
12066168|NCT00004061|Drug|ifosfamide|
12066169|NCT00004061|Procedure|peripheral blood stem cell transplantation|
12066170|NCT00004061|Procedure|quality-of-life assessment|
12066171|NCT00004061|Radiation|radiation therapy|
12066172|NCT00004030|Drug|VX-853|
12066173|NCT00004030|Drug|pegylated liposomal doxorubicin hydrochloride|
12066174|NCT00004012|Drug|capecitabine|
12066175|NCT00003985|Drug|KRN7000|
12066176|NCT00003984|Biological|lintuzumab|
12066177|NCT00003982|Drug|sabarubicin|
12066178|NCT00003980|Drug|BIBX 1382|
12066179|NCT00003944|Biological|filgrastim|
12066180|NCT00003944|Drug|carboplatin|
12066183|NCT00003944|Drug|topotecan hydrochloride|
12066184|NCT00003944|Procedure|peripheral blood stem cell transplantation|
12066185|NCT00003846|Biological|filgrastim|
12066186|NCT00003846|Drug|carboplatin|
12066187|NCT00003846|Drug|cyclophosphamide|
12066188|NCT00003846|Drug|thiotepa|
12066189|NCT00003846|Drug|vincristine sulfate|
12066190|NCT00003846|Procedure|bone marrow ablation with stem cell support|
12066191|NCT00003846|Procedure|peripheral blood stem cell transplantation|
12066192|NCT00003846|Radiation|radiation therapy|
12066193|NCT00003752|Drug|bexarotene|
12066194|NCT00003669|Drug|arzoxifene hydrochloride|
12066195|NCT00003580|Drug|amifostine trihydrate|
12066196|NCT00003580|Drug|cisplatin|
12066197|NCT00003580|Radiation|radiation therapy|
12066198|NCT00083382|Drug|Pamidronate|Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
12066199|NCT00083382|Drug|Thalidomide|"All Patients will receive thalidomide 200 mg as an oral, once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met.
~Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)"
12066200|NCT00083382|Drug|Zometa|Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.
12066201|NCT00083343|Drug|MK0991, caspofungin acetate/Duration of Treatment: variable|
12066202|NCT00008229|Biological|filgrastim|
12066203|NCT00008229|Drug|melphalan|
12066204|NCT00008229|Procedure|peripheral blood stem cell transplantation|
12066205|NCT00008229|Radiation|holmium Ho 166 DOTMP|
12066206|NCT00008073|Drug|doxorubicin hydrochloride|
12066207|NCT00008073|Drug|octreotide acetate|
12066208|NCT00006344|Radiation|radiation therapy|
12066209|NCT00006269|Drug|irinotecan hydrochloride|
12066210|NCT00006269|Drug|octreotide acetate|
12066211|NCT00003614|Drug|estramustine phosphate sodium|
12066212|NCT00003614|Drug|paclitaxel|
12066213|NCT00003523|Drug|aminocamptothecin colloidal dispersion|
12066214|NCT00003518|Drug|gemcitabine hydrochloride|
12066215|NCT00003518|Drug|paclitaxel|
12066216|NCT00003444|Biological|recombinant interferon alfa|
12066217|NCT00003444|Radiation|radiation therapy|
12066218|NCT00003405|Biological|recombinant interferon alfa|
12066219|NCT00003405|Drug|amifostine trihydrate|
12066220|NCT00003405|Drug|bromodeoxyuridine|
12066221|NCT00003405|Drug|cytarabine|
12066222|NCT00003405|Drug|idarubicin|
12066223|NCT00003405|Drug|idoxuridine|
12066224|NCT00003405|Drug|isotretinoin|
12066225|NCT00003405|Drug|mitoxantrone hydrochloride|
12066226|NCT00003403|Drug|GPX-100|
12066227|NCT00003269|Biological|sargramostim|
12066228|NCT00003269|Drug|amifostine trihydrate|
12066229|NCT00003269|Drug|cisplatin|
12066230|NCT00003269|Drug|cyclophosphamide|
12066231|NCT00003269|Drug|etoposide|
12066232|NCT00003195|Biological|recombinant interferon alfa|
12066233|NCT00003195|Drug|busulfan|
12066234|NCT00003195|Procedure|allogeneic bone marrow transplantation|
12066235|NCT00003195|Procedure|peripheral blood stem cell transplantation|
12066236|NCT00003195|Radiation|radiation therapy|
12066237|NCT00003187|Biological|filgrastim|
12066238|NCT00003187|Drug|cyclophosphamide|
12066239|NCT00003187|Drug|cyclosporine|
12066240|NCT00003187|Drug|cytarabine|
12066241|NCT00003187|Drug|methotrexate|
12066242|NCT00003187|Drug|methylprednisolone|
12066243|NCT00003187|Procedure|allogeneic bone marrow transplantation|
12066244|NCT00003187|Procedure|in vitro-treated bone marrow transplantation|
12066245|NCT00003187|Radiation|radiation therapy|
12066246|NCT00003098|Other|fat reduction with increased fiber|Patients are randomized to dietary fat reduction with increased fiber. All patient must successfully complete a dietary run-in phase for 4 weeks before randomization. During the run-in phase, patients are asked to maintain a food record for days 7-14. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14, 21, and 28. Patients are given 3 prepackaged meals a day for 12 weeks. Patients must maintain a record of all food eaten and return all food containers to the center for documentation. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70, 77, and 84. At the end of the 12 weeks, patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat, high fiber diet for the second phase of the study.
12066247|NCT00003098|Other|fat reduction without increased fiber|Patients are randomized to dietary fat reduction without increased fiber. All patient must successfully complete a dietary run-in phase for 4 weeks before randomization. During the run-in phase, patients are asked to maintain a food record for days 7-14. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14, 21, and 28. Patients are given 3 prepackaged meals a day for 12 weeks. Patients must maintain a record of all food eaten and return all food containers to the center for documentation. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70, 77, and 84. At the end of the 12 weeks, patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat, high fiber diet for the second phase of the study.
12066248|NCT00003084|Drug|Doxorubicin Hydrochloride|Doxorubicin IV on days 1, 15, and 29.
12066249|NCT00003084|Drug|Estramustine phosphate sodium|"Arm I: Oral estramustine three times a day for 21 day cycle.
~Arm II: Oral estramustine three times a day on days 8-14, 22-28, and 36-42 in 8 week cycle."
12066250|NCT00003084|Drug|Etoposide|Oral etoposide twice daily on days 1-14.
12066251|NCT00003084|Drug|Ketoconazole|Oral ketoconazole three times a day on days 1-7, 15-21, and 29-35.
12066252|NCT00003084|Drug|Paclitaxel|IV over 1 hour on day 2.
12066253|NCT00003084|Drug|Vinblastine|IV on days 8, 22, and 36.
12066254|NCT00003056|Drug|cyclosporine|
12066255|NCT00003056|Drug|cyclosporine and methotrexate|
12066256|NCT00003004|Drug|alvocidib|
12066257|NCT00003004|Drug|cisplatin|
12066258|NCT00003004|Drug|paclitaxel|
12066259|NCT00002924|Other|mutation analysis|
12066260|NCT00002902|Drug|irinotecan hydrochloride|
12066261|NCT00002902|Drug|raltitrexed|
12066262|NCT00002875|Biological|filgrastim|
12066263|NCT00002875|Drug|cisplatin|
12066264|NCT00002875|Drug|cyclophosphamide|
12066265|NCT00002875|Drug|lomustine|
12066266|NCT00002875|Drug|mesna|
12066267|NCT00002875|Drug|vincristine sulfate|
12066268|NCT00002875|Radiation|low-LET electron therapy|
12066269|NCT00002875|Radiation|low-LET photon therapy|
12066270|NCT00002780|Biological|aldesleukin|
12066271|NCT00002780|Biological|cytokine therapy|
12066272|NCT00002780|Biological|sargramostim|
12066273|NCT00002780|Drug|carboplatin|
12066274|NCT00002780|Drug|cyclophosphamide|
12066275|NCT00002780|Drug|thiotepa|
12066276|NCT00002780|Procedure|peripheral blood stem cell transplantation|
12066277|NCT00002750|Drug|melphalan|
12066278|NCT00002734|Biological|recombinant interferon alfa|
12066279|NCT00002734|Drug|chemotherapy|
12066280|NCT00002734|Drug|paclitaxel|
12066281|NCT00002734|Drug|topotecan hydrochloride|
12066282|NCT00002734|Radiation|lutetium Lu 177 monoclonal antibody CC49|
12066283|NCT00002734|Radiation|yttrium Y 90 monoclonal antibody CC49|
12066284|NCT00002671|Drug|aminocamptothecin|
12066285|NCT00002664|Biological|edrecolomab|
12066286|NCT00002664|Biological|sargramostim|
12066287|NCT00002576|Drug|cyclophosphamide|
12066288|NCT00002576|Drug|doxorubicin hydrochloride|
12066289|NCT00002576|Drug|mitoxantrone hydrochloride|
12066290|NCT00002576|Drug|prednisolone|
12066291|NCT00002576|Drug|vincristine sulfate|
12066292|NCT00002571|Biological|bleomycin sulfate|5u/m2 IV Q21days x 6 cycles
12066293|NCT00002571|Biological|filgrastim|5ug/kg SC, Days 9-20, Q 21 days x 6 cycles
12066294|NCT00002571|Drug|cyclophosphamide|490 mg/m2 IV Q 21 days x 6 cycles
12066295|NCT00002571|Drug|cytarabine|225 mg/m2 IV Q 21 days x 6 cycles
12066296|NCT00002571|Drug|doxorubicin hydrochloride|19 mg/m2 IV Q 21 days x 6 cycles
12066297|NCT00002571|Drug|etoposide|90 mg/m2 IV Q 21 days x 6 cycles
12066298|NCT00002571|Drug|leucovorin calcium|25 mg/m2 po 24 hours after methotrexate Q 6 hours x 4 doses for 6 cycles.
12066299|NCT00002571|Drug|methotrexate|90 mg/m2 IV, Q 21 days x 6 cycles.
12066300|NCT00002571|Drug|prednisone|60 mg/m2 po QD x 14days for 6 cycles
12066301|NCT00002571|Drug|trimethoprim-sulfamethoxazole|1 double throughout strength treatment tablet po on Monday, Wednesday, and Friday x 6, 21 day cycles
12066302|NCT00002571|Drug|vincristine sulfate|1.4 mg/m2 IV Q 21 Days x 6 cycles
12066303|NCT00002571|Radiation|radiation therapy|All patients achieving a CR or PR following systemic therapy and IT Ara-C, will receive 2,400 cGy in two hundred cGy fractions to the whole brain. Fields should adequately encompass all meningeal surfaces.
12066304|NCT00002571|Drug|Intrathecal cytarabine|"If initial bone marrow positive:
~Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first two cycles of therapy. Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle.
~If initial CSF cytology positive:
~Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first cycle of therapy. If CSF negative after above, Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle. If CSF positive after initial five doses of Ara-C, IT MTX 12 mg per dose x 5 doses should be given spaced evenly during the second cycle of therapy.
~If initial bone marrow and CSF negative:
~Ara-C 30 mg/m2 IT per dose x 5 doses to be given spaced evenly within 1 month of completion of systemic therapy."
12066305|NCT00002567|Biological|filgrastim|
12066306|NCT00002567|Drug|etoposide|
12066307|NCT00002567|Procedure|peripheral blood stem cell transplantation|
12066308|NCT00002567|Radiation|low-LET electron therapy|
12066309|NCT00002567|Radiation|low-LET photon therapy|
12066310|NCT00002552|Biological|filgrastim|
12066311|NCT00002552|Biological|sargramostim|
12066312|NCT00002552|Drug|carmustine|
12066313|NCT00002552|Drug|cyclophosphamide|
12066314|NCT00002552|Drug|cytarabine|
12066315|NCT00002552|Drug|etoposide|
12066316|NCT00002552|Drug|leucovorin calcium|
12066317|NCT00002552|Drug|methotrexate|
12066318|NCT00002552|Drug|perfosfamide|
12066319|NCT00002552|Drug|therapeutic hydrocortisone|
12066320|NCT00002552|Procedure|allogeneic bone marrow transplantation|
12066321|NCT00002552|Procedure|autologous bone marrow transplantation|
12066322|NCT00002552|Procedure|in vitro-treated bone marrow transplantation|
12066323|NCT00002552|Procedure|peripheral blood stem cell transplantation|
12066324|NCT00002552|Procedure|syngeneic bone marrow transplantation|
12066325|NCT00002552|Radiation|radiation therapy|
12066326|NCT00002547|Drug|busulfan|
12066327|NCT00002547|Drug|cyclophosphamide|
12066328|NCT00002547|Drug|cyclosporine|
12066329|NCT00002547|Drug|cytarabine|
12066330|NCT00002547|Drug|methotrexate|
12066331|NCT00002547|Procedure|allogeneic bone marrow transplantation|
12066332|NCT00002547|Procedure|syngeneic bone marrow transplantation|
12066333|NCT00083356|Procedure|Wisdom tooth extraction|
12066334|NCT00005648|Drug|Gemcitabine with R115777|R115777 200 mg, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years
12066335|NCT00005648|Drug|Gemcitabine with Placebo|Placebo, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years
12066336|NCT00004198|Biological|keyhole limpet hemocyanin|
12066337|NCT00004198|Biological|sargramostim|
12066338|NCT00004198|Biological|tumor cell-based vaccine therapy|
12066339|NCT00004126|Drug|oxaliplatin|
12066340|NCT00004126|Drug|paclitaxel|
12066341|NCT00004122|Biological|BCG vaccine|
12066342|NCT00004122|Biological|recombinant interferon alfa|
12066343|NCT00004113|Drug|temozolomide|
12066344|NCT00003976|Drug|indisulam|
12066345|NCT00003908|Drug|carboplatin|
12066346|NCT00003908|Drug|docetaxel|
12066347|NCT00003822|Drug|apomine|
12066348|NCT00003747|Drug|carboplatin|
12066349|NCT00003747|Drug|temozolomide|
12066350|NCT00003724|Procedure|surgical procedure|
12066351|NCT00003670|Drug|arzoxifene hydrochloride|
12066352|NCT00003606|Drug|cisplatin|
12066353|NCT00003606|Drug|cyclophosphamide|
12066354|NCT00003606|Drug|epirubicin hydrochloride|
12066355|NCT00003606|Drug|etoposide|
12066356|NCT00003606|Radiation|radiation therapy|
12066357|NCT00003562|Drug|carboplatin|
12066358|NCT00003562|Drug|docetaxel|
12066359|NCT00003490|Biological|sargramostim|
12066360|NCT00003490|Drug|cyclophosphamide|
12066361|NCT00003490|Drug|prednisone|
12066362|NCT00003490|Drug|vincristine sulfate|
12066363|NCT00003447|Drug|gemcitabine hydrochloride|
12066364|NCT00003447|Drug|vinorelbine tartrate|
12066365|NCT00003365|Dietary Supplement|curcumin|
12066366|NCT00003365|Dietary Supplement|rutin|
12066367|NCT00003365|Drug|quercetin|
12066368|NCT00003365|Drug|sulindac|
12066369|NCT00003322|Drug|cisplatin|
12066370|NCT00003322|Drug|paclitaxel|
12066371|NCT00003322|Procedure|quality-of-life assessment|
12066372|NCT00003289|Drug|7-hydroxystaurosporine|
12066373|NCT00003250|Drug|fenretinide|
12066374|NCT00003101|Biological|filgrastim|
12066375|NCT00003101|Drug|busulfan|
12066376|NCT00003101|Drug|lomustine|
12066377|NCT00003101|Drug|procarbazine hydrochloride|
12066378|NCT00003101|Drug|thiotepa|
12066379|NCT00003101|Drug|vincristine sulfate|
12066380|NCT00003101|Procedure|autologous bone marrow transplantation|
12066381|NCT00003101|Procedure|peripheral blood stem cell transplantation|
12066382|NCT00002880|Drug|Etoposide phosphate|50 mg PO q day for 21 days; repeat every 28 days escalate dose to 100 mg PO q day if ANC remains greater than 1500/microliter during cycle 1: no specified maximum of cycles if PR or CR
12066383|NCT00002876|Drug|cisplatin|
12066384|NCT00002876|Drug|etoposide|
12066385|NCT00002813|Drug|cisplatin|
12066386|NCT00002813|Drug|vinorelbine tartrate|
12066387|NCT00002787|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|Given SC
12066388|NCT00002787|Biological|sargramostim|Given SC
12066389|NCT00002787|Biological|aldesleukin|Given SC
12066390|NCT00002787|Other|laboratory biomarker analysis|Correlative studies
12066391|NCT00002707|Drug|Cyclophosphamide|600 mg/m2 IV every 21 days for 4 cycles
12066392|NCT00002707|Drug|Docetaxel|100 mg/m2 IV every 21 days for 4 cycles
12066393|NCT00002707|Drug|Doxorubicin|60 mg/m2 IV every 21 days fo 4 cycles
12066394|NCT00002707|Drug|Tamoxifen|20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
12066395|NCT00002692|Drug|fluorouracil|
12066396|NCT00002692|Drug|isolated perfusion|
12066397|NCT00002692|Drug|leucovorin calcium|
12066398|NCT00002673|Procedure|infection prophylaxis and management|
12066399|NCT00002599|Biological|filgrastim|
12066400|NCT00002599|Biological|recombinant interferon alfa|
12066401|NCT00002599|Biological|sargramostim|
12066402|NCT00002599|Drug|carmustine|
12066403|NCT00002599|Drug|cyclophosphamide|
12066404|NCT00002599|Drug|doxorubicin hydrochloride|
12066405|NCT00002599|Drug|melphalan|
12066406|NCT00002599|Drug|methylprednisolone|
12066407|NCT00002599|Drug|prednisone|
12066408|NCT00002599|Drug|vincristine sulfate|
12066409|NCT00002599|Radiation|low-LET cobalt-60 gamma ray therapy|
12066410|NCT00002599|Radiation|low-LET photon therapy|
12066411|NCT00083330|Drug|VRC-HIVADV014-00-VP|
12066412|NCT00083278|Drug|MDX-010|
12066413|NCT00012350|Drug|FTI|
12066414|NCT00010088|Drug|fluorouracil|
12066415|NCT00010088|Drug|gemcitabine hydrochloride|
12066416|NCT00010088|Drug|leucovorin calcium|
12066417|NCT00010088|Procedure|conventional surgery|
12066418|NCT00010088|Radiation|radiation therapy|
12066419|NCT00006220|Drug|arsenic trioxide|
12066420|NCT00006220|Drug|tretinoin|
12066421|NCT00005814|Biological|cetuximab|
12066422|NCT00005814|Drug|cisplatin|
12066423|NCT00005814|Radiation|radiation therapy|
12066424|NCT00005581|Drug|cyclophosphamide|
12066425|NCT00005581|Drug|epirubicin hydrochloride|
12066426|NCT00005581|Drug|fluorouracil|
12066427|NCT00005581|Drug|paclitaxel|
12066428|NCT00004880|Biological|dendritic cell vaccine therapy|
12066429|NCT00004880|Procedure|conventional surgery|
12066430|NCT00004211|Biological|PSA RNA-pulsed dendritic cell vaccine|
12066431|NCT00004156|Biological|MUC1-KLH vaccine/QS21|
12066432|NCT00004132|Biological|filgrastim|
12066433|NCT00004132|Biological|palifermin|
12066434|NCT00004132|Drug|cyclophosphamide|
12066435|NCT00004132|Drug|etoposide|
12066436|NCT00004132|Drug|ifosfamide|
12066437|NCT00004132|Procedure|quality-of-life assessment|
12066438|NCT00004132|Radiation|radiation therapy|
12066439|NCT00004073|Drug|suramin|
12066440|NCT00004073|Radiation|radiation therapy|
12066441|NCT00004056|Biological|filgrastim|
12066442|NCT00004056|Drug|asparaginase|
12066443|NCT00004056|Drug|cytarabine|
12066444|NCT00004056|Drug|daunorubicin hydrochloride|
12066445|NCT00004056|Drug|melphalan|
12066446|NCT00004056|Drug|thioguanine|
12066447|NCT00004056|Procedure|peripheral blood stem cell transplantation|
12066448|NCT00004051|Drug|irinotecan hydrochloride|
12066449|NCT00004038|Biological|Ad5CMV-p53 gene|
12066450|NCT00004038|Drug|chemotherapy|
12066451|NCT00003924|Biological|recombinant interferon alfa|
12066452|NCT00003876|Drug|polifeprosan 20 with carmustine implant|
12066453|NCT00003876|Procedure|surgical procedure|
12066454|NCT00003876|Radiation|iodine I 125|
12066455|NCT00003801|Procedure|management of therapy complications|
12066456|NCT00003801|Procedure|quality-of-life assessment|
12066457|NCT00003731|Drug|temozolomide|
12066458|NCT00003700|Biological|G-CSF|Courses I, II, IV, V: 5 ug/kg/d subQ injection Day 4 until ANC > 5,000 uL after nadir: 7 day minimum for Courses I & IV
12066459|NCT00003700|Drug|asparaginase|6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I & IV
12066460|NCT00003700|Drug|cyclophosphamide|1200 mg/sq m IV infusion over 15-30 min Day 1 Courses I & IV (pts < 60y/o) 1000 mg/sq m IV infusion over 15-30 min Day 1 Courses II & V
12066461|NCT00003700|Drug|cytarabine|2000 mg/sq m IV infusion over 3 hrs Days 1,2, & 3: Courses II & V
12066462|NCT00003700|Drug|daunorubicin hydrochloride|80mg/sq m (pts<60y/o)OR 60mg/sq m (pts =/>60y/o) IV infusion over 5-10 min Days 1,2,& 3: Courses I & IV
12066463|NCT00003700|Drug|leucovorin calcium|"Courses III & VI:
~25mg/sq m IV infusion Days 2, 9, and 16 5mg/sq m PO q 6 hr for 8 doses or until serum MTX <0.05 uM after ea IV dose"
12066464|NCT00003700|Drug|mercaptopurine|60mg/sq m/d PO every day Course VII
12066465|NCT00003700|Drug|methotrexate|15mg intrathecal Day 1 Courses II & V 1000mg/sq m IV infusion over 3 hrs Days 1, 8, & 15 and 25mg/sq m PO q 6hr x 4 doses after ea IV dose: Courses III & VI.
12066466|NCT00003700|Drug|prednisone|60mg/sq m/day PO Days 1-21 (pts<60y/o) OR Days 1-7 (pts >/= 60y/o) Courses I & IV and Days 1-5 of ea 4 cycle in Course VII
12066467|NCT00003700|Drug|vincristine sulfate|2 mg total IV infusion Days 1,8,15,& 22 Courses I & IV and Days 1, 8, & 15 Courses III & VI, and Day 1 of ea 4 wk cycle in Course VII
12066468|NCT00003700|Drug|Allopurinol|300mg PO q day Days 1-14 Course I
12066469|NCT00003698|Drug|fosbretabulin disodium|
12066470|NCT00003697|Drug|vadimezan|
12066471|NCT00003685|Procedure|fatigue assessment and management|
12066472|NCT00003685|Procedure|nausea and vomiting therapy|
12066473|NCT00003685|Procedure|pain therapy|
12066474|NCT00003685|Procedure|quality-of-life assessment|
12066475|NCT00003685|Radiation|radiation therapy|
12066476|NCT00003640|Biological|filgrastim|
12066477|NCT00003640|Drug|cisplatin|
12066478|NCT00003640|Drug|doxorubicin hydrochloride|
12066479|NCT00003640|Drug|methotrexate|
12066480|NCT00003640|Drug|vinblastine sulfate|
12066481|NCT00003640|Procedure|surgical procedure|
12066482|NCT00003640|Radiation|radiation therapy|
12066483|NCT00003575|Biological|filgrastim|
12066484|NCT00003575|Biological|recombinant interleukin-12|
12066485|NCT00003575|Drug|etoposide|
12066486|NCT00003575|Drug|ifosfamide|
12066487|NCT00003439|Biological|recombinant interleukin-12|
12066488|NCT00003423|Drug|asparaginase|
12066489|NCT00003423|Drug|cyclophosphamide|
12066490|NCT00003423|Drug|cytarabine|
12066491|NCT00003423|Drug|daunorubicin hydrochloride|
12066492|NCT00003423|Drug|dexamethasone|
12066493|NCT00003423|Drug|etoposide|
12066494|NCT00003423|Drug|mercaptopurine|
12066495|NCT00003423|Drug|methotrexate|
12066496|NCT00003423|Drug|prednisolone|
12066497|NCT00003423|Drug|thioguanine|
12066498|NCT00003423|Drug|vincristine sulfate|
12066499|NCT00003330|Biological|recombinant interleukin-12|
12066500|NCT00003326|Drug|paclitaxel|
12066501|NCT00003255|Drug|carboplatin|
12066502|NCT00003255|Drug|topotecan hydrochloride|
12066503|NCT00002578|Drug|cytarabine|
12066504|NCT00002578|Drug|gallium nitrate|
12066505|NCT00002578|Drug|leucovorin calcium|
12066506|NCT00002578|Drug|methotrexate|
12066507|NCT00002503|Radiation|strontium chloride Sr 89|
12066508|NCT00083304|Drug|Efaproxiral|"75 mg/kg, administered over 30 minutes via a central venous access device (CVAD).
~Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days."
12066509|NCT00083304|Radiation|Whole Brain Radiation Therapy (WBRT)|3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
12066510|NCT00083304|Other|Supplemental Oxygen|"4 L/minute by nasal cannula.
~Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days."
12066511|NCT00083213|Biological|ziv-aflibercept|
12066512|NCT00082940|Biological|denileukin diftitox|
12066513|NCT00082927|Drug|ibandronate sodium|
12066514|NCT00082914|Biological|denileukin diftitox|
12066515|NCT00082888|Other|Laboratory Biomarker Analysis|Correlative studies
12066516|NCT00082888|Drug|Tipifarnib|Given PO
12066517|NCT00082875|Drug|cilengitide|Given IV
12066518|NCT00082875|Other|pharmacological study|Correlative studies
12066519|NCT00082875|Other|laboratory biomarker analysis|Correlative studies
12066520|NCT00082862|Biological|recombinant interferon alfa|
12066521|NCT00082862|Drug|cisplatin|
12066522|NCT00082862|Drug|gemcitabine hydrochloride|
12066523|NCT00082862|Procedure|hyperthermia treatment|
12066524|NCT00082836|Biological|rituximab|
12066525|NCT00082836|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12066526|NCT00082823|Biological|ziv-aflibercept|
12066527|NCT00082810|Drug|fulvestrant|Given intramuscularly
12066528|NCT00082810|Drug|tipifarnib|Given IV
12066529|NCT00082797|Drug|leucovorin calcium|
12066530|NCT00082797|Drug|methotrexate|
12066531|NCT00082784|Drug|Bortezomib|Given IV
12066532|NCT00082784|Drug|Alvocidib Hydrochloride|Given IV
12066533|NCT00082784|Other|Pharmacological Study|Correlative studies
12066534|NCT00082758|Biological|hu14.18-Interleukin-2 fusion protein|Given IV
12066535|NCT00082745|Other|Laboratory Biomarker Analysis|Correlative studies
12066536|NCT00082745|Other|Questionnaire Administration|Ancillary studies
12066537|NCT00082732|Behavioral|behavioral dietary intervention|
12066538|NCT00082732|Dietary Supplement|dietary intervention|
12066539|NCT00082732|Procedure|therapeutic dietary intervention|
12066540|NCT00082719|Biological|Recombinant Interferon Alfa|"In all arms, treatment begins at pre-operative visit and continues until cystoscopy.
~Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose."
12066541|NCT00082706|Drug|5-Fluorouracil (5-FU)|Day: 1 - 5 Dose: 200 mg/m2 IVCI daily x 5 days
12066542|NCT00082706|Drug|Leucovorin|Day: 1 - 5 Dose:10 mg/m2 daily x 5 days
12066543|NCT00082706|Drug|Cisplatin|Day: 1 - 5 Dose: 20 mg/m2 daily x 5 days
12066544|NCT00082706|Drug|Gemcitabine|Day: 1 & 5 Dose: 200 mg/m2 (Two doses only)
12066545|NCT00082667|Drug|gefitinib|
12066546|NCT00082667|Procedure|Surgery|
12066547|NCT00082654|Procedure|psychosocial assessment and care|
12066548|NCT00082641|Biological|autologous dendritic cell-adenovirus p53 vaccine|Given subcutaneously on one of two schedules
12066549|NCT00003186|Drug|isosulfan blue|
12066550|NCT00003186|Procedure|lymphangiography|
12066551|NCT00003186|Procedure|sentinel lymph node biopsy|
12066552|NCT00003183|Biological|filgrastim|
12066553|NCT00003183|Drug|mitoxantrone hydrochloride|
12066554|NCT00003154|Drug|aminocamptothecin colloidal dispersion|120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months.
12066555|NCT00003118|Drug|cisplatin|
12066556|NCT00003118|Drug|fluorouracil|
12066557|NCT00003118|Procedure|surgical procedure|
12066558|NCT00003118|Radiation|radiation therapy|
12066559|NCT00003117|Drug|carboplatin|
12066560|NCT00003117|Drug|paclitaxel|
12066561|NCT00003020|Biological|LMB-7 immunotoxin|
12066562|NCT00002988|Drug|carmustine|
12066563|NCT00002988|Drug|irinotecan hydrochloride|
12066564|NCT00002985|Drug|daunorubicin hydrochloride|
12066565|NCT00002985|Drug|pegylated liposomal doxorubicin hydrochloride|
12066566|NCT00002961|Drug|cyclophosphamide|Arms A and B Day 2 and 3: Cyclophosphamide 60 mg/kg intravenously; Administer 20 mg/ml concentration over 2 hours.
12066567|NCT00002961|Drug|cyclosporine|"graft vs. host disease (GVHD)prophylaxis: starting on day-1, cyclosporin 1.5 mg/kg IV every 12 hours or by continuous infusion.
~When the patient tolerates adequate oral intake, cyclosporin therapy may be changed from IV to oral administration. Cyclosporin therapy should be continued at full dose until day +50. if the patient has less than Grade 2 GVHD, cyclosporin may be tapered by 5-10% weekly until completely off cyclosporin therapy."
12066568|NCT00002961|Drug|etoposide|Day 4 (arms A/B): 40 mg/kg over four hours intravenously
12066569|NCT00002961|Drug|methotrexate|"methotrexate 15 mg/m2 IV on day +1 (do not give until 24 hours after marrow infusion), and 10mg/mg2 IV on days +3 and +6.
~Methotrexate may be held after two doses for bilirubin .2 mg/dL. If serum creatinine is >2x baseline, methotrexate will be omitted. If the presence of ascites or pleural effusion, methotrexate will be omitted."
12066570|NCT00002961|Procedure|allogeneic bone marrow transplantation|Bone marrow infusion given on day 0
12066571|NCT00002961|Radiation|Total Body Irradiation|Day 0: Marrow Transfusion; Day 1: rest; Day 2 and 3: Cyclophosphamide 60 mg/kg; Day 4: Etopophos 40 mg/kg over four hours; Day 5,6 and 7: Total Body Irradiation (TBI) [200 cGy twice a day (BID)].
12066572|NCT00002961|Drug|Busulfan|"Conditioning Regimen Arm B:
~Day 0: Marrow infusion; Day 1: Rest; Day 2 and 3: Cyclophosphamide 60 mg/kg; Day 4: Etopophos 40 mg/kg over four hours; Day 5,6,7 and 8: Busulfan 0.8 mg/kg intravenous (IV) every 6 hours x 4 doses.
~Patients </= 20kg to receive busulfan 1.0 mg/kg/dose IV**Busulfan oral preparation may be substituted: 1mg/kg/dose by mouth (po) for patients >20kg and 1.25 mg/kg/dose by mouth (po) for patients </= 20 kg."
12066573|NCT00002961|Drug|Mesna|Dosing per institutional preference for hemorrhagic cystitis. Mesna 300 mg/m2 as a 15 minute infusion prior to each dose of cyclophosphamide, then at 3,6,9,12, 18 and 21 hours after initiation of each cyclophosphamide infusion. Alternative method of Mesna administration is 10 mg/kg prior to cyclophosphamide and 100 mg/kg/24 hours by continuous infusion.
12066574|NCT00002961|Radiation|Radiation|"Central Nervous System (CNS) therapy:
~a) CNS Leukemia prior to study entry: No TBI i) No prior CNS irradiation: 2340 centigray (cGy) in 13 fractions of 180 cGy to the cranial field and 600 cGy in 200 cGy fractions to the spinal field prior to conditioning. II) >/= 1800 cGy prior CNS irradiation: 1800 cGy to cranial field and 600 cGy spinal prior to conditioning. If prior radiation therapy (RT) doses >3000 cGy have been administered or CNS Leukemia prior to study entry: TBI, consult with Principal Investigator (PI). Recommend: 1) no prior CNS irradiation: 600 cGy in 3 fractions to the cranial field prior to conditioning or overlapping with TBI.
~Testicular Boost Irradiation: a) overt testicular leukemia at relapse: No TBI 2400 cGy in 12 fractions prior to conditioning; b) overt testicular leukemia at relapse: TBI 1200 cGy in 6 fractions over 8-10 days prior to conditioning. c) No overt testicular leukemia: 200 cGy first and last fractions of TBI-"
12066575|NCT00083252|Drug|talabostat (PT-100) tablets|
12066576|NCT00083252|Drug|cisplatin|
12066577|NCT00083239|Drug|talabostat (PT-100) tablets|
12066578|NCT00083226|Drug|doxorubicin|Given IV
12066579|NCT00083226|Drug|bortezomib|Given IV
12066580|NCT00083187|Drug|hydroxyurea|
12066581|NCT00083187|Drug|laromustine|
12066582|NCT00083174|Drug|exemestane|one 25 mg tablet daily in am
12066583|NCT00083161|Drug|cisplatin|60 mg/m2 IV day 1, every 21 days for 4 cycles.
12066584|NCT00083161|Drug|cyclophosphamide|25 mg by mouth BID days 8-19 or each cycle x 4 cycles. After restaging (if no progression) maintenance cyclophosphamide alone 25 mg by mouth BID daily until disease progression
12066585|NCT00083161|Drug|etoposide|120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3
12066586|NCT00083148|Drug|capecitabine|
12066587|NCT00083148|Drug|irinotecan hydrochloride|
12066589|NCT00083135|Procedure|autologous bone marrow transplantation|
12066590|NCT00083135|Procedure|peripheral blood stem cell transplantation|
12066591|NCT00083135|Radiation|iobenguane I 131|
12066592|NCT00083122|Drug|cisplatin|Given IV
12066593|NCT00083122|Drug|alvocidib|Given IV
12066594|NCT00083122|Drug|cisplatin/flavopiridol|Given IV
12066595|NCT00083109|Drug|Fluorouracil|Given IV
12066596|NCT00083109|Other|Pharmacological Study|Correlative studies
12066597|NCT00083109|Drug|Suramin|Given IV
12066598|NCT00083096|Drug|lonafarnib|
12066599|NCT00083096|Drug|temozolomide|
12066600|NCT00083083|Drug|carboplatin|
12066601|NCT00083083|Drug|cisplatin|
12066602|NCT00083083|Drug|docetaxel|
12066603|NCT00083083|Drug|etoposide|
12066604|NCT00083083|Drug|paclitaxel|
12066605|NCT00083083|Drug|vinblastine sulfate|
12066606|NCT00083083|Drug|vinorelbine tartrate|
12066607|NCT00083083|Genetic|gene expression analysis|
12066608|NCT00083083|Procedure|positron emission tomography|
12066609|NCT00083083|Radiation|fludeoxyglucose F 18|
12066610|NCT00083083|Radiation|radiation therapy|
12066611|NCT00083070|Drug|temozolomide|
12066612|NCT00083057|Drug|gefitinib|
12066613|NCT00083057|Drug|paclitaxel|
12066614|NCT00083057|Radiation|radiation therapy|
12066615|NCT00083031|Drug|bevacizumab|
12066616|NCT00083031|Drug|cyclophosphamide|
12066617|NCT00083031|Drug|methotrexate|
12066618|NCT00083018|Genetic|cytogenetic analysis|
12066619|NCT00083018|Genetic|proteomic profiling|
12066620|NCT00083018|Other|cytology specimen collection procedure|
12066621|NCT00083018|Other|immunohistochemistry staining method|
12066622|NCT00083018|Other|laboratory biomarker analysis|
12066623|NCT00083018|Procedure|breast duct lavage|
12066624|NCT00083005|Drug|docetaxel|
12066625|NCT00083005|Drug|estramustine phosphate sodium|
12066626|NCT00083005|Drug|thalidomide|
12066627|NCT00082979|Genetic|cytogenetic analysis|
12066628|NCT00082979|Genetic|proteomic profiling|
12066629|NCT00082979|Other|cytology specimen collection procedure|
12066630|NCT00082979|Other|immunohistochemistry staining method|
12066631|NCT00082979|Other|laboratory biomarker analysis|
12066632|NCT00082979|Procedure|breast duct lavage|
12066633|NCT00082966|Drug|17-N-allylamino-17-demethoxygeldanamycin/bortezomib|Given IV
12066634|NCT00082628|Drug|Placebo|Placebo matched to serostim® as subcutaneous injection.
12066635|NCT00082628|Drug|Serostim® 4 mg|Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight.
12066636|NCT00082628|Drug|Serostim® 2 mg|Serostim® 2 mg as subcutaneous injection on alternate days.
12066637|NCT00082602|Drug|galantamine ER|
12066638|NCT00082589|Drug|Eplerenone|
12066639|NCT00082576|Drug|Azithromycin/Chloroquine|
12066640|NCT00082576|Drug|Mefloquine|
12066641|NCT00082563|Drug|Azithromycin/Chloroquine|
12066642|NCT00082563|Drug|Chloroquine|
12066643|NCT00082537|Drug|caspofungin acetate|Duration of Treatment: 28-90 days
12066644|NCT00082537|Drug|Comparator: AmBisome|Duration of Treatment: 28-90 days
12066645|NCT00082524|Drug|caspofungin acetate|Duration of Treatment - 7-90 days
12066646|NCT00002936|Drug|altretamine|
12066647|NCT00002936|Drug|etoposide|
12066648|NCT00002903|Drug|docetaxel|
12066649|NCT00002896|Drug|chemotherapy|
12066650|NCT00002896|Drug|fluorouracil|
12066651|NCT00002896|Drug|leucovorin calcium|
12066652|NCT00002896|Procedure|conventional surgery|
12066653|NCT00002896|Radiation|low-LET cobalt-60 gamma ray therapy|
12066654|NCT00002896|Radiation|low-LET photon therapy|
12066655|NCT00002893|Drug|fluorouracil|
12066656|NCT00002893|Drug|leucovorin calcium|
12066657|NCT00002893|Drug|raltitrexed|
12066658|NCT00002892|Biological|recombinant interferon alfa|
12066659|NCT00082498|Drug|SCH-D (vicriviroc)|Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment.
12066660|NCT00082498|Drug|Placebo|Patients in Group 1 will receive placebo.
12066661|NCT00082485|Drug|Baclofen|Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
12066662|NCT00082485|Other|Placebo|Placebo
12066663|NCT00082472|Drug|Doxorubicin HCl Inhalation Solution|
12066664|NCT00082472|Drug|Docetaxel|
12066665|NCT00082472|Drug|Cisplatin|
12066666|NCT00082459|Biological|autologous human tumor-derived HSPPC-96|
12066667|NCT00002870|Biological|filgrastim|
12066668|NCT00002870|Drug|cyclophosphamide|
12066669|NCT00002870|Drug|epirubicin hydrochloride|
12066670|NCT00002870|Drug|fluorouracil|
12066671|NCT00002870|Drug|thiotepa|
12066672|NCT00002870|Procedure|peripheral blood stem cell transplantation|
12066673|NCT00002826|Drug|paclitaxel|
12066674|NCT00002826|Drug|valspodar|
12066675|NCT00002803|Drug|cyclophosphamide|
12066676|NCT00002803|Drug|doxorubicin hydrochloride|
12066677|NCT00002803|Drug|vincristine sulfate|
12066678|NCT00002803|Procedure|conventional surgery|
12066679|NCT00002802|Drug|carboplatin|
12066680|NCT00002802|Drug|cisplatin|
12066681|NCT00002802|Drug|cyclophosphamide|
12066682|NCT00002802|Drug|dacarbazine|
12066683|NCT00002802|Drug|doxorubicin hydrochloride|
12066684|NCT00002802|Drug|etoposide|
12066685|NCT00002802|Drug|ifosfamide|
12066686|NCT00002802|Drug|melphalan|
12066688|NCT00002802|Drug|vincristine sulfate|
12066689|NCT00002802|Drug|vindesine|
12066690|NCT00002802|Procedure|autologous bone marrow transplantation|
12066691|NCT00002802|Procedure|conventional surgery|
12066692|NCT00002802|Radiation|low-LET cobalt-60 gamma ray therapy|
12066693|NCT00002802|Radiation|low-LET electron therapy|
12066694|NCT00002802|Radiation|low-LET photon therapy|
12066695|NCT00002802|Radiation|radioisotope therapy|
12066696|NCT00082446|Biological|Live vaccinia virus vaccine|Dryvax®: 0.25 mL of vaccine will be administered by the standard route of scarification using a bifurcated needle on day 112 for Groups A, B, C, D and F.
12066697|NCT00082446|Biological|MVA Smallpox Vaccine|Imvamune/MVA-BN 1x10^8 will be administered intramuscularly to Group F on day 0 and day 28.
12066698|NCT00082446|Biological|MVA Smallpox Vaccine|Imvamune/MVA-BN Groups A, B C and E will be administered subcutaneously: 2x10^7, 5x10^7, 1x10^8, 1x10^8, respectively, on days 0 and day 28.
12066699|NCT00082446|Other|Placebo|Group E will receive sterile saline placebo for injection via scarification on day 112.
12066700|NCT00082446|Other|Placebo|Group D will receive sterile saline placebo for injection subcutaneously on day 0 and day 28.
12066701|NCT00082433|Drug|Ixabepilone + Capecitabine|Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
12066702|NCT00082433|Drug|Capecitabine|Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle
12066703|NCT00082381|Drug|Exenatide (AC2993)|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
12066704|NCT00082381|Drug|Insulin glargine|subcutaneous injection, once daily; forced titration to target blood glucose level
12066705|NCT00002788|Biological|filgrastim|
12066706|NCT00002788|Drug|cyclophosphamide|
12066707|NCT00002788|Drug|dexamethasone|
12066708|NCT00002788|Drug|etoposide|
12066709|NCT00002788|Procedure|peripheral blood stem cell transplantation|
12066710|NCT00002788|Radiation|radiation therapy|
12066711|NCT00002737|Biological|recombinant interferon alfa|
12066712|NCT00002737|Drug|chemotherapy|
12066713|NCT00002737|Drug|isotretinoin|
12066714|NCT00002677|Drug|chemotherapy|
12066715|NCT00002677|Drug|tributyrin|
12066716|NCT00002644|Drug|Tamoxifen Citrate 20Mg Tab|Tamoxifen Citrate 20Mg Tab
12066717|NCT00002644|Other|Placebo|Placebo 20Mg Tab
12066718|NCT00002587|Drug|paclitaxel|
12066719|NCT00002587|Drug|topotecan hydrochloride|
12066720|NCT00082407|Drug|exenatide|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
12066721|NCT00082407|Drug|biphasic insulin aspart|subcutaneous injection, twice daily; titration to target blood glucose level
12066722|NCT00082394|Drug|Trizivir|
12066723|NCT00082394|Drug|atazanavir|
12066724|NCT00082394|Drug|Combivir|
12066725|NCT00082316|Drug|Capsaicin Dermal Patch|
12066726|NCT00082368|Drug|Tariquidar|3 days after initial PET patients will receive tariquidar and repeat imaging.
12066727|NCT00082368|Drug|Tc-94m Sestamibi|Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI (National Cancer Institute) protocol for treatment of cancer will undergo a PET sestamibi scan
12066728|NCT00082355|Drug|Alteplase (Activase, Genentech)|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 4 day period.
12066729|NCT00082342|Device|Phoressor II (IOMED)|sham stimulation
12066730|NCT00082342|Device|Phoressor II (IOMED)|real tDCS stimulation
12066731|NCT00082329|Drug|AMD 3100 (Mozobil plerixafor)|Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
12066732|NCT00082303|Behavioral|Music Imagery|
12066733|NCT00082290|Other|massage therapy|
12066734|NCT00082290|Other|visit with a volunteer|
12066735|NCT00082290|Other|period of quiet time|
12066736|NCT00082290|Behavioral|questionaire about pain|
12066737|NCT00082277|Drug|Anastrozole|1mg/Day Oral
12066738|NCT00082277|Drug|Risedronate Sodium|35mg/week, oral
12066739|NCT00082251|Drug|Niacin extended release and simvastatin tablets|
12066740|NCT00082238|Other|Stable isotopes|Stable isotopes were used to quantify gluconeogenesis GNG, hepatic glucose production (HGP), and protein breakdown.
12066741|NCT00082225|Biological|CD45 antibodies|The antibody solution is administered by a syringe pump in incremental doses, 0.2-0.8 mg in the first hour and up to 10 mg/hr thereafter, for a maximum infusion time of 8 hrs.
12066742|NCT00082225|Biological|EBV specific T cells|"The following dose levels will be evaluated: Each patient will receive 1 injection, according to the following dosing schedules:
~2 x 10e7 cells/m2 5 x 10e7 cells/m2
~1 x 10e8 cells/m2"
12066743|NCT00082212|Biological|Cetuximab|400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
12066744|NCT00014651|Drug|vapreotide|
12066745|NCT00014651|Procedure|conventional surgery|
12066746|NCT00010322|Drug|atamestane|
12066747|NCT00010322|Drug|toremifene|
12066748|NCT00008255|Drug|INS316|
12066749|NCT00008255|Other|sputum cytology|
12066750|NCT00002568|Drug|cisplatin|
12066751|NCT00002568|Drug|paclitaxel|
12066752|NCT00002568|Procedure|conventional surgery|
12066753|NCT00002516|Biological|dactinomycin|
12066754|NCT00002516|Drug|cyclophosphamide|
12066755|NCT00002516|Drug|doxorubicin hydrochloride|
12066756|NCT00002516|Drug|etoposide|
12066757|NCT00002516|Drug|ifosfamide|
12066758|NCT00002516|Drug|mesna|
12066759|NCT00002516|Drug|vincristine sulfate|
12066760|NCT00002516|Procedure|conventional surgery|
12066761|NCT00002516|Radiation|low-LET cobalt-60 gamma ray therapy|
12066762|NCT00002516|Radiation|low-LET photon therapy|
12066763|NCT00082199|Drug|Aripiprazole|Tablets, Oral, 2-30mg, Once daily, 12 weeks.
12066764|NCT00082199|Drug|Placebo|Tablets, Oral, Once daily, 12 weeks.
12066765|NCT00082186|Drug|bosentan|Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
12066766|NCT00082173|Drug|Moxifloxacin|400mg daily for 8 weeks
12066767|NCT00082160|Behavioral|Meditation|
12066768|NCT00082160|Procedure|Functional Magnetic Resonance Imaging|
12066769|NCT00082134|Drug|ILX651|
12066770|NCT00082121|Drug|TP10|
12066771|NCT00011934|Biological|recombinant interferon alfa|
12066772|NCT00011934|Biological|sargramostim|
12066773|NCT00011934|Procedure|autologous bone marrow transplantation|
12066774|NCT00008242|Drug|dexamethasone|
12066775|NCT00008242|Drug|doxorubicin hydrochloride|
12066776|NCT00008242|Drug|thalidomide|
12066777|NCT00008125|Biological|filgrastim|
12066778|NCT00008125|Drug|carboplatin|
12066779|NCT00008125|Drug|docetaxel|
12066780|NCT00008125|Drug|gemcitabine hydrochloride|
12066781|NCT00008099|Biological|MUC1 antigen/SB AS-2|
12066782|NCT00006682|Drug|docetaxel|Docetaxel 70mg/m2 on day 1 of every 21-day cycle
12066783|NCT00006682|Drug|vinorelbine ditartrate|Navelbine 20mg/m2 on Day 1 and D8 of a 21-day cycle
12066784|NCT00006669|Biological|rituximab|
12066785|NCT00006669|Biological|sargramostim|
12066786|NCT00006669|Drug|EPOCH regimen|
12066787|NCT00006669|Drug|cyclophosphamide|
12066788|NCT00006669|Drug|doxorubicin hydrochloride|
12066789|NCT00006669|Drug|etoposide|
12066790|NCT00006669|Drug|prednisone|
12066791|NCT00006669|Drug|vincristine sulfate|
12066792|NCT00006342|Genetic|chromosomal translocation analysis|
12066793|NCT00006342|Genetic|gene rearrangement analysis|
12066794|NCT00006342|Genetic|mutation analysis|
12066795|NCT00006112|Drug|chemotherapy|
12066796|NCT00006112|Drug|fluorouracil|
12066797|NCT00006112|Drug|leucovorin calcium|
12066798|NCT00006112|Drug|mitomycin C|
12066799|NCT00006097|Drug|CC-1088|
12066800|NCT00006053|Drug|imatinib mesylate|
12066801|NCT00006039|Biological|pegylated interferon alfa|
12066802|NCT00005988|Drug|cyclophosphamide|
12066803|NCT00005988|Drug|cyclosporine|
12066804|NCT00005988|Drug|leucovorin calcium|
12066805|NCT00005988|Drug|methotrexate|
12066806|NCT00005988|Drug|methylprednisolone|
12066807|NCT00005988|Procedure|in vitro-treated bone marrow transplantation|
12066808|NCT00005988|Radiation|radiation therapy|
12066809|NCT00005974|Drug|alvocidib|Flavopiridol 50 mg/m2 IV over 1 hour daily x 3 days every 3 weeks
12066810|NCT00005871|Drug|fluorouracil|
12066811|NCT00005871|Drug|rubitecan|
12066812|NCT00005612|Biological|filgrastim|
12066813|NCT00005612|Drug|carboplatin|
12066814|NCT00005612|Drug|cyclophosphamide|
12066815|NCT00005612|Drug|etoposide|
12066816|NCT00005612|Drug|paclitaxel|
12066817|NCT00005612|Drug|topotecan hydrochloride|
12066818|NCT00005612|Procedure|peripheral blood stem cell transplantation|
12066819|NCT00005594|Drug|ISIS 2503|Beginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle.
12066820|NCT00005081|Drug|O6-benzylguanine|
12066821|NCT00005081|Drug|carmustine|
12066822|NCT00005055|Drug|glufosfamide|
12066823|NCT00005053|Drug|glufosfamide|
12066824|NCT00005021|Biological|filgrastim|
12066825|NCT00005021|Drug|carboplatin|
12066826|NCT00005021|Drug|paclitaxel|
12066827|NCT00005021|Drug|topotecan hydrochloride|
12066828|NCT00004893|Biological|recombinant interleukin-12|
12066829|NCT00004892|Drug|O6-benzylguanine|
12066830|NCT00004892|Drug|polifeprosan 20 with carmustine implant|
12066831|NCT00004892|Procedure|conventional surgery|
12066832|NCT00004884|Drug|cisplatin|
12066833|NCT00004884|Drug|docetaxel|
12066834|NCT00004884|Drug|gemcitabine hydrochloride|
12066835|NCT00004246|Drug|Fludarabine Phosphate|IV on days 1-5 of weeks 6 and 7 of radiotherapy, administered 3-4 hours prior to daily radiotherapy.
12066836|NCT00004246|Radiation|Radiation Therapy (RT)|Days 1-5 for 7 weeks
12066837|NCT00004230|Drug|captopril|
12066838|NCT00004230|Drug|cyclophosphamide|
12066839|NCT00004230|Procedure|autologous bone marrow transplantation|
12066840|NCT00004230|Procedure|peripheral blood stem cell transplantation|
12066841|NCT00004230|Radiation|radiation therapy|
12066842|NCT00004213|Drug|triapine|
12066843|NCT00004101|Biological|apolizumab|
12066844|NCT00004049|Drug|apomine|
12066845|NCT00003972|Biological|filgrastim|
12066846|NCT00003972|Biological|sargramostim|
12066847|NCT00003972|Drug|busulfan|
12066848|NCT00003972|Drug|carboplatin|
12066849|NCT00003972|Drug|cyclophosphamide|
12066850|NCT00003972|Drug|melphalan|
12066851|NCT00003972|Drug|paclitaxel|
12066852|NCT00003972|Drug|tamoxifen citrate|
12066853|NCT00003972|Drug|thiotepa|
12066854|NCT00003972|Procedure|peripheral blood stem cell transplantation|
12066855|NCT00003972|Radiation|radiation therapy|
12066856|NCT00003968|Drug|bryostatin 1|
12066857|NCT00003943|Biological|filgrastim|5 ug/kg
12066858|NCT00003943|Drug|carboplatin|AUC 5
12066859|NCT00003943|Drug|cyclophosphamide|3 gm/m2
12066860|NCT00003943|Drug|paclitaxel|250 mg/m2
12066861|NCT00003943|Drug|topotecan hydrochloride|10 mg/m2
12066862|NCT00003943|Procedure|peripheral blood stem cell transplantation|harvest via apheresis
12066863|NCT00003900|Drug|docetaxel|
12066864|NCT00003900|Drug|irinotecan hydrochloride|
12066865|NCT00003849|Biological|rituximab|
12066866|NCT00003825|Drug|pentosan polysulfate sodium|
12066867|NCT00003825|Procedure|quality-of-life assessment|
12066868|NCT00003768|Drug|fosbretabulin disodium|
12066869|NCT00003726|Biological|lepirudin|lepirudin
12066870|NCT00003713|Drug|intoplicine|
12066871|NCT00003680|Drug|CMF regimen|
12066872|NCT00003680|Drug|cyclophosphamide|
12066873|NCT00003680|Drug|fluorouracil|
12066874|NCT00003680|Drug|methotrexate|
12066875|NCT00003680|Drug|tamoxifen citrate|
12066876|NCT00003680|Drug|thiotepa|
12066877|NCT00003680|Procedure|peripheral blood stem cell transplantation|
12066878|NCT00003680|Radiation|radiation therapy|
12066879|NCT00003646|Drug|allovectin-7|
12066880|NCT00003638|Biological|Detox-B adjuvant|
12066881|NCT00003638|Biological|THERATOPE STn-KLH vaccine|
12066882|NCT00003638|Biological|keyhole limpet hemocyanin|
12066883|NCT00003638|Drug|cyclophosphamide|
12066884|NCT00003622|Drug|paclitaxel|
12066885|NCT00003622|Drug|vinorelbine tartrate|
12066886|NCT00082147|Procedure|Biopsy|Patients will then undergo endorectal coil MR imaging of the prostate gland, including conventional anatomic imaging and dynamic-contrast-enhanced MRI During MR imaging, 4 to 10 needle biopsy cores of the prostate will be obtained using a trans-rectal needle guide system (APT-MRI).
12066887|NCT00082095|Drug|Pegylated liposomal doxorubicin|Type=exact number, unit=mg/m2, number=40, form=infusion, route=intravenous. Pegylated liposomal doxorubicin will be administered on Day 1 of each cycle. Cycle will be repeated every 28 days, up to 1 year.
12066888|NCT00082095|Drug|Capecitabine|Type=exact number, unit=mg, number=500, form=tablet, route=oral. Capecitabine will be administered at a dosage of 1000 mg/m2 twice daily for 14 consecutive days followed by a 7-day rest period. Cycle is repeated every 21 days, up to one year.
12066889|NCT00082082|Drug|Thymalfasin (thymosin alpha-1)|
12066890|NCT00082082|Procedure|Trans arterial chemoembolization (TACE)|
12066891|NCT00082069|Biological|Shigella flexneri 2a Invaplex 50|
12066892|NCT00081978|Drug|TMC125|
12066893|NCT00003583|Drug|amifostine trihydrate|
12066894|NCT00003583|Drug|cisplatin|
12066895|NCT00003583|Drug|etoposide|
12066896|NCT00003583|Radiation|radiation therapy|
12066897|NCT00003563|Radiation|WBRT|3 GY of WBRT daily for a total of 10 days
12066898|NCT00003563|Drug|MGd|5.0 mg /kg MGd plus WBRT
12066899|NCT00003554|Biological|rituximab|
12066900|NCT00003554|Drug|melphalan|
12066901|NCT00003554|Drug|prednisone|
12066902|NCT00003397|Biological|filgrastim|
12066903|NCT00003397|Biological|rituximab|
12066904|NCT00003397|Biological|sargramostim|
12066905|NCT00003397|Drug|carmustine|
12066906|NCT00003397|Drug|cisplatin|
12066907|NCT00003397|Drug|cyclophosphamide|
12066908|NCT00003397|Drug|dexamethasone|
12066909|NCT00003397|Drug|etoposide|
12066910|NCT00003397|Drug|gemcitabine hydrochloride|
12066911|NCT00003397|Drug|melphalan|
12066912|NCT00003397|Drug|paclitaxel|
12066913|NCT00003397|Procedure|bone marrow ablation with stem cell support|
12066914|NCT00003397|Procedure|peripheral blood stem cell transplantation|
12066915|NCT00003394|Drug|carboplatin|
12066916|NCT00003394|Drug|endocrine-modulating drug therapy|
12066917|NCT00003394|Drug|estramustine phosphate sodium|
12066918|NCT00003394|Drug|goserelin acetate|
12066919|NCT00003394|Drug|leuprolide acetate|
12066920|NCT00003394|Drug|paclitaxel|
12066921|NCT00003276|Drug|irinotecan hydrochloride|
12066922|NCT00003239|Biological|Recombinant Interferon Alfa|Daily by subcutaneous injection.
12066923|NCT00003239|Drug|Cytarabine|Daily by subcutaneous injection.
12066924|NCT00003239|Drug|Omacetaxine Mepesuccinate|Homoharringtonine is administered by continuous infusion on days 1-5.
12066925|NCT00003181|Biological|aldesleukin|
12066926|NCT00003181|Biological|sargramostim|
12066927|NCT00003181|Drug|vinblastine sulfate|
12066928|NCT00003175|Drug|fluorouracil|
12066929|NCT00003165|Drug|doxorubicin-HPMA conjugate|
12066930|NCT00003133|Biological|filgrastim|
12066931|NCT00003133|Drug|cisplatin|
12066932|NCT00003133|Drug|doxorubicin hydrochloride|
12066933|NCT00003133|Drug|gemcitabine hydrochloride|
12066934|NCT00003133|Drug|paclitaxel|
12066935|NCT00003038|Drug|doxorubicin hydrochloride|
12066936|NCT00003038|Drug|suramin|
12066937|NCT00003019|Drug|methotrexate|
12066938|NCT00003019|Drug|vinblastine sulfate|
12066939|NCT00081939|Drug|Velcade|Two cycles of induction on days 1,4,8,11 at 1.0mg/m^2. Two cycles of consolidation on days 1,4,8,11 at 1.0mg/m^2. Maintenance year one 1.0mg/m^2 1,4,8,11 q 28 days.
12066940|NCT00081939|Drug|Thalidomide|Two cycles of VDTPACE 200mg thal days 4-7(cycle 1)and days 1-4 cycle 2 interim Thal 50mg qd between VTDPACE cycles and between cycle 2 and transplant. Thal 100mg between transplants d/c 7 days prior to each transplant. Consolidation therapy cycles 3 and 4 VDTPACE 200mg days 1-4 both cycles. Interim maintenance to maintenance 100mg qd. Maintenance year 1 thal 100mg qd. Maintenance years 2 and 3 Thal 100mg qd.
12066941|NCT00081926|Drug|Gleevec|
12066942|NCT00014365|Drug|MKC-1|
12066943|NCT00006483|Biological|sargramostim|
12066944|NCT00006261|Biological|therapeutic allogeneic lymphocytes|Beginning on day 120 after PBSC transplantation, eligible patients receive unmobilized donor lymphocyte infusion (DLI) over 15-30 minutes. Treatment continues monthly for a total of 3 DLIs in the absence of grade III or IV graft versus host disease or marrow aplasia.
12066945|NCT00006261|Drug|cyclophosphamide|4-10 weeks after completion of salvage chemotherapy, patients achieving complete or partial remission or stable disease receive mini-conditioning comprised of cyclophosphamide IV over 2 hours on days -3 and -2.
12066946|NCT00006261|Drug|docetaxel|Docetaxel IV over 1 hour. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
12066947|NCT00006261|Drug|doxorubicin hydrochloride|Doxorubicin IV over several minutes on day 1. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
12066948|NCT00006261|Drug|fludarabine phosphate|4-10 weeks after completion of salvage chemotherapy, patients achieving complete or partial remission or stable disease receive mini-conditioning comprised of fludarabine IV over 30 minutes on days -8 to -4.
12066949|NCT00006261|Procedure|peripheral blood stem cell transplantation|Filgrastim (G-CSF) and sargramostim (GM-CSF) mobilized allogeneic peripheral blood stem cells (PBSC) IV on day 0.
12066950|NCT00006106|Drug|cisplatin|
12066951|NCT00006106|Drug|fluorouracil|
12066952|NCT00006106|Drug|ONYX-015|
12066953|NCT00003001|Drug|fluorouracil|
12066954|NCT00003001|Drug|gemcitabine hydrochloride|
12066955|NCT00003001|Drug|leucovorin calcium|
12066956|NCT00002977|Biological|filgrastim|
12066957|NCT00002977|Drug|melphalan|
12066958|NCT00002977|Drug|thiotepa|
12066959|NCT00002977|Procedure|peripheral blood stem cell transplantation|
12066960|NCT00002939|Drug|irinotecan hydrochloride|
12066961|NCT00002939|Drug|paclitaxel|
12066962|NCT00002912|Drug|etoposide|
12066963|NCT00002912|Drug|mitoxantrone hydrochloride|
12066964|NCT00002912|Drug|valspodar|
12066965|NCT00002884|Drug|chemotherapy|
12066966|NCT00002884|Drug|cisplatin|
12066967|NCT00002884|Drug|fluorouracil|
12066968|NCT00002884|Radiation|brachytherapy|
12066969|NCT00002884|Radiation|radiation therapy|
12066970|NCT00002773|Biological|allogeneic tumor cell vaccine|
12066971|NCT00002773|Biological|recombinant interferon alfa|
12066972|NCT00002773|Biological|sargramostim|
12066973|NCT00002773|Drug|cyclophosphamide|
12066974|NCT00002719|Biological|filgrastim|
12066975|NCT00002719|Drug|amsacrine|
12066976|NCT00002719|Drug|carmustine|
12066977|NCT00002719|Drug|cytarabine|
12066978|NCT00002719|Drug|etoposide|
12066979|NCT00002719|Drug|idarubicin|
12066980|NCT00002719|Drug|mitoxantrone hydrochloride|
12066981|NCT00002719|Procedure|peripheral blood stem cell transplantation|
12066982|NCT00002680|Biological|filgrastim|
12066983|NCT00002680|Drug|cyclophosphamide|
12066984|NCT00002680|Drug|megestrol acetate|
12066985|NCT00002680|Drug|melphalan|
12066986|NCT00002680|Drug|tamoxifen citrate|
12066987|NCT00002680|Drug|thiotepa|
12066988|NCT00002680|Procedure|conventional surgery|
12066989|NCT00002680|Procedure|peripheral blood stem cell transplantation|
12066990|NCT00002680|Radiation|radiation therapy|
12066991|NCT00002590|Biological|filgrastim|
12066992|NCT00002590|Drug|cyclophosphamide|
12066993|NCT00002590|Drug|cytarabine|
12066994|NCT00002590|Drug|daunorubicin hydrochloride|
12066995|NCT00002590|Drug|doxorubicin hydrochloride|
12066996|NCT00002590|Drug|etoposide|
12066997|NCT00002590|Drug|leucovorin calcium|
12066998|NCT00002590|Drug|methotrexate|
12066999|NCT00002590|Drug|pegaspargase|
12067000|NCT00002590|Drug|prednisone|
12067001|NCT00002590|Drug|thioguanine|
12067002|NCT00002590|Drug|vincristine sulfate|
12067003|NCT00002590|Radiation|radiation therapy|
12067004|NCT00002564|Other|educational intervention|
12067005|NCT00002564|Procedure|therapeutic dietary intervention|
12067006|NCT00002481|Drug|cisplatin|
12067007|NCT00002481|Drug|cyclophosphamide|
12067008|NCT00002481|Drug|cytarabine|
12067009|NCT00002481|Drug|dexamethasone|
12067010|NCT00002481|Drug|etoposide|
12067011|NCT00002481|Procedure|autologous bone marrow transplantation|
12067012|NCT00002481|Radiation|radiation therapy|
12067013|NCT00082043|Drug|Dutasteride|
12067014|NCT00082043|Drug|Placebo oral capsule|
12067015|NCT00082017|Drug|UCN-01 (7-hydroxystaurosporine)|"UCN-01 for relapsed or refractory T-cell lymphomas - Cohort 1, Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.
~UCN-01 for relapsed or refractory T-cell lymphomas - Cohort 2, Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
12067016|NCT00081965|Procedure|acupuncture therapy|
12067017|NCT00081965|Procedure|hot flashes attenuation|
12067018|NCT00081965|Procedure|management of therapy complications|
12067019|NCT00081952|Drug|L-norleucine|
12067020|NCT00081913|Genetic|Cell Therapy - Autologous CD34 Positive Cells|
12067021|NCT00081900|Drug|DENSPM )|Each patient will receive DENSPM at an initial dose of 30mg/m^2, then escalating to 120mg/m^2, single IV infusion on D1,3,5,8,10,12 of every 28 days as one cycle, planned for 8 cycles if no withdrawn occur
12067022|NCT00005969|Drug|Chemotherapy|
12067023|NCT00005969|Drug|Tretinoin Liposome|Liposome by vein (IV) over 30 minutes every other day for 28 days
12067024|NCT00005883|Drug|phenethyl isothiocyanate|
12067025|NCT00005796|Procedure|filgrastim|GCSF is given after chemo administration
12067026|NCT00005796|Biological|gene therapy|stem cells are collected and given back to the patients after chemotherapy adminstration
12067027|NCT00005796|Drug|lomustine|chemotherapy is administered every 21 days
12067028|NCT00005796|Drug|procarbazine hydrochloride|chemotherapy is administered every 21 days.
12067029|NCT00005796|Drug|vincristine sulfate|chemotherapy is administered every 21 days
12067030|NCT00005796|Procedure|in vitro-treated peripheral blood stem cell transplantation|stem cells are reinfused after chemotherapy administration
12067031|NCT00005649|Drug|capecitabine|
12067032|NCT00005649|Drug|paclitaxel|
12067033|NCT00004933|Drug|hydroxyurea|0.5 to 5 grams PO per day
12067034|NCT00004933|Drug|Homoharringtonine|2.5 mg/ sq m/ day CIVI for 14 days
12067035|NCT00004923|Drug|docetaxel|
12067036|NCT00004923|Drug|irinotecan hydrochloride|
12067037|NCT00004903|Biological|filgrastim|
12067038|NCT00004903|Biological|recombinant interferon alfa|
12067044|NCT00004903|Procedure|peripheral blood stem cell transplantation|
12067045|NCT00004878|Biological|therapeutic allogeneic lymphocytes|
12067046|NCT00004878|Drug|cytarabine|
12067047|NCT00004878|Drug|fludarabine phosphate|
12067048|NCT00004878|Drug|idarubicin|
12067049|NCT00004878|Drug|methotrexate|
12067050|NCT00004878|Drug|tacrolimus|
12067051|NCT00004878|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12067052|NCT00004878|Procedure|peripheral blood stem cell transplantation|
12067053|NCT00004872|Biological|recombinant human endostatin|
12067054|NCT00004858|Biological|B43-genistein immunoconjugate|
12067055|NCT00004604|Biological|CEA RNA-pulsed DC cancer vaccine|carcinoembryonic antigen RNA-pulsed dendritic cells
12067056|NCT00004249|Biological|QS21|
12067057|NCT00004249|Biological|keyhole limpet hemocyanin|
12067058|NCT00004249|Drug|polysialic acid|
12067059|NCT00004174|Biological|filgrastim|
12067060|NCT00004174|Drug|cyclophosphamide|
12067061|NCT00004174|Drug|paclitaxel|
12067062|NCT00004174|Drug|thiotepa|
12067063|NCT00004174|Procedure|peripheral blood stem cell transplantation|
12067064|NCT00004174|Radiation|radiation therapy|
12067065|NCT00003960|Drug|busulfan|
12067066|NCT00003960|Drug|cyclophosphamide|
12067067|NCT00003960|Drug|methylprednisolone|
12067068|NCT00003960|Procedure|allogeneic bone marrow transplantation|
12067069|NCT00003960|Procedure|in vitro-treated bone marrow transplantation|
12067070|NCT00003953|Biological|filgrastim|Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each 2 week course.
12067071|NCT00003953|Drug|CMF regimen|Stratum I and II: receive cyclophosphamide, methotrexate, and fluorouracil (CMF) for 4 courses
12067072|NCT00003953|Drug|docetaxel|Docetaxel IV over 1 hour on days 43, 57, and 71.
12067073|NCT00003953|Drug|doxorubicin hydrochloride|Doxorubicin IV on days 1, 15, and 29.
12067074|NCT00003953|Drug|tamoxifen citrate|Patients with positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years.
12067075|NCT00003953|Procedure|autologous bone marrow transplantation|Stratum III:may receive high dose chemotherapy with stem cell support
12067076|NCT00003953|Procedure|surgical procedure|Fourteen to 21 days following preoperative chemotherapy, patients undergo a radical, modified radical, or breast sparing surgery plus axillary lymph node dissection.
12067077|NCT00003953|Radiation|radiation therapy|Radiotherapy is administered 5 days a week for 5.5 weeks.
12067078|NCT00081887|Drug|Clofarabine|Starting dose is 10 mg/m^2 as a 1-hour infusion into a vein once every 2 weeks for 4 weeks (1 cycle).
12067079|NCT00081874|Drug|RAD001|"Phase I: Starting dose 5 mg by mouth daily for 28 days.
~Phase II: Maximum Tolerated Dose (MTD) from Phase I."
12067080|NCT00081861|Drug|Avastin|10 mg/kg given intravenously every 2 weeks for 4 doses.
12067081|NCT00081861|Drug|Rituximab|375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.
12067082|NCT00003950|Drug|cyclosporine|
12067083|NCT00003950|Drug|CPT-11|
12067084|NCT00003914|Drug|dolastatin 10|
12067085|NCT00003887|Biological|peripheral blood lymphocyte therapy|
12067086|NCT00003835|Drug|leucovorin calcium|Given IV
12067087|NCT00003835|Drug|fluorouracil|Given IV
12067088|NCT00003835|Drug|irinotecan hydrochloride|Given IV
12067089|NCT00003835|Other|laboratory biomarker analysis|Correlative studies
12067090|NCT00003819|Biological|QS21|
12067091|NCT00003819|Biological|TF(c)-KLH conjugate vaccine|
12067092|NCT00003819|Biological|Thomsen-Friedenreich antigen|
12067093|NCT00003819|Biological|keyhole limpet hemocyanin|
12067094|NCT00003783|Biological|filgrastim|
12067095|NCT00003783|Drug|asparaginase|
12067096|NCT00003783|Drug|cyclophosphamide|
12067097|NCT00003783|Drug|cytarabine|
12067098|NCT00003783|Drug|daunorubicin hydrochloride|
12067099|NCT00003783|Drug|dexamethasone|
12067100|NCT00003783|Drug|etoposide|
12067101|NCT00003783|Drug|idarubicin|
12067102|NCT00003783|Drug|leucovorin calcium|
12067103|NCT00003783|Drug|mercaptopurine|
12067104|NCT00003783|Drug|methotrexate|
12067105|NCT00003783|Drug|prednisone|
12067106|NCT00003783|Drug|vincristine sulfate|
12067107|NCT00003783|Radiation|radiation therapy|
12067108|NCT00003765|Drug|O6-benzylguanine|
12067109|NCT00003765|Drug|carmustine|
12067110|NCT00003619|Biological|filgrastim|
12067111|NCT00003619|Dietary Supplement|vitamin E|
12067112|NCT00003619|Drug|busulfan|
12067113|NCT00003619|Drug|cytarabine|
12067114|NCT00003619|Drug|etoposide|
12067115|NCT00003619|Drug|fludarabine phosphate|
12067116|NCT00003619|Drug|isotretinoin|
12067117|NCT00003619|Drug|topotecan hydrochloride|
12067118|NCT00003619|Procedure|bone marrow ablation with stem cell support|
12067119|NCT00003619|Procedure|peripheral blood stem cell transplantation|
12067120|NCT00003544|Drug|irinotecan hydrochloride|
12067121|NCT00003544|Procedure|surgical procedure|
12067122|NCT00003434|Biological|carcinoembryonic antigen peptide 1|
12067123|NCT00003434|Biological|hepatitis B antigen peptide|
12067124|NCT00003427|Drug|irinotecan hydrochloride|
12067125|NCT00003427|Drug|oxaliplatin|
12067126|NCT00003407|Drug|amifostine trihydrate|
12067127|NCT00003407|Drug|cytarabine|
12067128|NCT00003407|Drug|mitoxantrone hydrochloride|
12067129|NCT00003398|Biological|anti-thymocyte globulin|
12067130|NCT00003398|Biological|filgrastim|
12067131|NCT00003398|Drug|cyclophosphamide|
12067132|NCT00003398|Drug|thiotepa|
12067133|NCT00003398|Procedure|allogeneic bone marrow transplantation|
12067134|NCT00003398|Procedure|bone marrow ablation with stem cell support|
12067135|NCT00003398|Radiation|radiation therapy|
12067136|NCT00003270|Biological|anti-thymocyte globulin|IV
12067137|NCT00003270|Biological|filgrastim|IV
12067139|NCT00003270|Drug|cyclophosphamide|IV
12067140|NCT00003270|Drug|cyclosporine|IV
12067141|NCT00003270|Drug|methylprednisolone|IV
12067142|NCT00003270|Procedure|bone marrow ablation with stem cell support|IV
12067143|NCT00003270|Procedure|umbilical cord blood transplantation|IV
12067144|NCT00003270|Radiation|radiation therapy|High energy X-rays
12067145|NCT00003144|Drug|amifostine trihydrate|
12067146|NCT00003144|Drug|cisplatin|
12067147|NCT00003144|Drug|gemcitabine hydrochloride|
12067148|NCT00003094|Other|preventative dietary intervention|
12067149|NCT00003081|Biological|filgrastim|
12067150|NCT00003081|Drug|busulfan|
12067151|NCT00003081|Drug|melphalan|
12067152|NCT00003081|Drug|thiotepa|
12067153|NCT00003081|Procedure|peripheral blood stem cell transplantation|
12067154|NCT00003081|Radiation|radiation therapy|
12067155|NCT00002964|Drug|porfimer sodium|
12067156|NCT00002964|Other|fluorophotometry|
12067157|NCT00002866|Biological|filgrastim|
12067158|NCT00002866|Drug|docetaxel|
12067159|NCT00002866|Drug|epirubicin hydrochloride|
12067160|NCT00006475|Drug|imatinib mesylate|
12067161|NCT00006463|Drug|ECTEINASCIDIN 743|
12067162|NCT00006357|Drug|imatinib mesylate|
12067163|NCT00006216|Biological|PA-1-STK ovarian carcinoma vaccine|
12067164|NCT00006216|Drug|ganciclovir|
12067165|NCT00006049|Drug|carboplatin|
12067166|NCT00006049|Drug|gefitinib|
12067167|NCT00006049|Drug|paclitaxel|
12067168|NCT00006048|Drug|cisplatin|
12067169|NCT00006048|Drug|gefitinib|
12067170|NCT00006048|Drug|gemcitabine hydrochloride|
12067171|NCT00005870|Drug|fluorouracil|
12067172|NCT00005870|Drug|gemcitabine hydrochloride|
12067173|NCT00005870|Drug|mitomycin C|
12067174|NCT00005870|Drug|rubitecan|
12067175|NCT00005849|Drug|bryostatin 1|
12067176|NCT00005849|Drug|paclitaxel|
12067177|NCT00005842|Biological|trastuzumab|
12067178|NCT00005842|Drug|tipifarnib|
12067179|NCT00005832|Drug|R115777|300mg/dose BID, PO, Days 1-21, q 28days
12067180|NCT00002794|Drug|carboplatin|
12067181|NCT00002794|Drug|vincristine sulfate|
12067182|NCT00002553|Drug|cyclophosphamide|
12067183|NCT00002553|Procedure|allogeneic bone marrow transplantation|
12067184|NCT00002553|Radiation|low-LET cobalt-60 gamma ray therapy|
12067185|NCT00002485|Procedure|psychosocial assessment and care|
12067186|NCT00002466|Drug|cyclophosphamide|
12067187|NCT00002466|Drug|doxorubicin hydrochloride|
12067188|NCT00002466|Drug|etoposide|
12067189|NCT00002466|Drug|ifosfamide|
12067190|NCT00002466|Drug|vincristine sulfate|
12067191|NCT00002466|Procedure|conventional surgery|
12067192|NCT00002466|Radiation|radiation therapy|
12067193|NCT00002456|Drug|cyclosporine|
12067194|NCT00002456|Drug|methotrexate|
12067195|NCT00002456|Procedure|allogeneic bone marrow transplantation|
12067196|NCT00081822|Drug|clofarabine|Clofarabine should be administered by daily intravenous infusion over 2 hours.Following demonstration of DLT at Dose Level -I (22.5 mg/m2/day days 2-6) and demonstration that Dose Level -II (15mg/m2day days 2-6) is the 'optimal phase II dose', an additional Dose Level -1½ (20mg/m2/day, days 2-6) will be added to explore an increased dose of clofarabine intermediate between Dose Levels -I and -II.
12067197|NCT00081822|Drug|Ara-C|Ara-C: Administer Ara-C by continuous infusion of 100mg/m2/day on days 1 to 7 for cycle 1, and on days 1 to 5 for cycles 2 & 3.
12067198|NCT00081809|Drug|autologous human tumor-derived HSPPC-96|
12067199|NCT00005092|Drug|Cyclophosphamide|IV over 2 hours on days 2 and 3
12067200|NCT00005092|Drug|Psoralen|Psoralen treated T-cell allogeneic transplant on day 9
12067201|NCT00005092|Drug|Thiotepa|IV over 2 hours on day 1
12067202|NCT00005092|Procedure|Allogeneic bone marrow transplantation|Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9
12067203|NCT00005092|Procedure|In vitro-treated peripheral blood stem cell transplantation (PBSCT)|Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9
12067204|NCT00005092|Radiation|Radiation Therapy (RT)|Whole body radiotherapy on days 5-8.
12067205|NCT00005082|Procedure|biopsy|
12067206|NCT00005082|Procedure|magnetic resonance imaging|
12067207|NCT00005023|Biological|HER-2/neu peptide vaccine|
12067208|NCT00005023|Biological|sargramostim|
12067209|NCT00004870|Biological|oblimersen sodium|
12067210|NCT00004870|Drug|irinotecan hydrochloride|
12067211|NCT00004254|Drug|raltitrexed|
12067212|NCT00004013|Biological|trastuzumab|
12067213|NCT00004013|Drug|paclitaxel|
12067214|NCT00003899|Biological|filgrastim|
12067215|NCT00003899|Drug|cyclophosphamide|
12067216|NCT00003899|Drug|melphalan|
12067217|NCT00003899|Drug|paclitaxel|
12067218|NCT00003899|Drug|thiotepa|
12067219|NCT00003899|Procedure|autologous bone marrow transplantation|
12067220|NCT00003899|Procedure|peripheral blood stem cell transplantation|
12067221|NCT00003880|Biological|recombinant adenovirus-p53 SCH-58500|
12067222|NCT00003880|Drug|carboplatin|
12067223|NCT00003880|Drug|paclitaxel|
12067224|NCT00003790|Genetic|polymerase chain reaction|
12067225|NCT00003790|Other|flow cytometry|
12067226|NCT00003735|Drug|topotecan hydrochloride|given by mouth
12067227|NCT00003715|Biological|BCG vaccine|
12067228|NCT00003715|Biological|autologous tumor cell vaccine|
12067229|NCT00003715|Biological|recombinant interferon alfa|
12067230|NCT00003715|Drug|chemotherapy|
12067231|NCT00003715|Drug|cyclophosphamide|
12067232|NCT00003701|Drug|carboplatin|
12067233|NCT00003701|Drug|cisplatin|
12067234|NCT00003701|Drug|doxorubicin hydrochloride|
12067235|NCT00003701|Drug|methotrexate|
12067236|NCT00003701|Drug|paclitaxel|
12067237|NCT00003701|Drug|vinblastine sulfate|
12067238|NCT00003621|Drug|carmustine|
12067239|NCT00003621|Drug|cisplatin|
12067240|NCT00003621|Drug|etoposide|
12067241|NCT00003621|Radiation|radiation therapy|
12067242|NCT00003445|Drug|docetaxel|
12067243|NCT00003386|Biological|BCG vaccine|
12067244|NCT00003386|Biological|autologous tumor cell vaccine|
12067245|NCT00003386|Drug|carboplatin|
12067246|NCT00003386|Drug|cisplatin|
12067247|NCT00003386|Drug|cyclophosphamide|
12067248|NCT00003386|Drug|paclitaxel|
12067249|NCT00003386|Other|dinitrophenyl|
12067250|NCT00003386|Procedure|surgical procedure|
12067251|NCT00003148|Biological|aldesleukin|
12067252|NCT00003146|Drug|busulfan|
12067253|NCT00003146|Drug|melphalan|
12067254|NCT00003146|Drug|thiotepa|
12067255|NCT00003146|Procedure|bone marrow transplantation|
12067256|NCT00003146|Procedure|peripheral blood stem cell transplantation|
12067257|NCT00003076|Drug|eflornithine|
12067258|NCT00003041|Drug|pyrazoloacridine|
12067259|NCT00081848|Drug|rV-CEA(6D)/TRICOM-rF-CEA(6D)/TRICOM|
12067260|NCT00081848|Drug|rF-CEA(6D)/TRICOM|
12067261|NCT00081848|Drug|Recombinant Fowlpox-GM-CSF|
12067262|NCT00081848|Drug|Celecoxib|
12067263|NCT00081835|Drug|NP-016 Vaccine Immune Globulin (IV-VIG)|
12067264|NCT00081796|Drug|larotaxel (RPR109881, XRP9881)|
12067265|NCT00081796|Drug|capecitabine|
12067266|NCT00081783|Drug|Xcellerated T Cells|
12067267|NCT00081770|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|1.5 ug/kg/week subcutaneously (SC) for 48 weeks
12067268|NCT00081770|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|1.0 ug/kg/week SC for 48 weeks
12067269|NCT00081770|Drug|REBETOL (ribavirin; SCH 18908)|weight based dose 800-1400 mg/day orally (PO) for 48 weeks
12067270|NCT00081770|Biological|PEGASYS (peginterferon alfa-2a)|180 ug/week SC administered for 48 weeks
12067271|NCT00081770|Drug|COPEGUS (ribavirin)|1000-1200 mg/day PO for 48 weeks
12067272|NCT00081757|Drug|Thalidomide|
12067273|NCT00021346|Drug|carboplatin|
12067274|NCT00021346|Drug|gemcitabine hydrochloride|
12067275|NCT00019357|Biological|aldesleukin|
12067276|NCT00019357|Biological|therapeutic autologous lymphocytes|
12067277|NCT00019357|Biological|therapeutic tumor infiltrating lymphocytes|
12067278|NCT00003018|Drug|dipyridamole|75mg/dose, PO, Days 1-28 of 5 week cycle
12067279|NCT00003018|Drug|fluorouracil|200 mg/m^2/day, continuous IV, Days 1-28 of 5 week cycle
12067280|NCT00003018|Drug|leucovorin calcium|30 mg/m^2/day, IV, Days 1,8,15,22 of 5 week cycle
12067281|NCT00003018|Drug|mitomycin C|10 mg/m^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
12067282|NCT00003017|Biological|recombinant interleukin-12|
12067283|NCT00002952|Biological|MART-1 antigen|Melan-A peptide loaded PBMCs (sc, q3wk x 3)
12067284|NCT00002952|Biological|recombinant MAGE-3.1 antigen|
12067285|NCT00002952|Biological|recombinant interleukin-12|rhIL-12 (4 mcg, sc, days 1, 3 and 5 of every 3 wk cycle)
12067286|NCT00002889|Drug|flutamide|
12067287|NCT00002889|Drug|goserelin|
12067288|NCT00002889|Drug|leuprolide acetate|
12067289|NCT00002889|Radiation|low-LET photon therapy|
12067290|NCT00002818|Drug|cytarabine|
12067291|NCT00002818|Drug|deoxycytidine|
12067292|NCT00002800|Biological|filgrastim|
12067293|NCT00002800|Biological|lintuzumab|
12067294|NCT00002800|Drug|cytarabine|
12067295|NCT00002800|Drug|etoposide|
12067296|NCT00002800|Drug|idarubicin|
12067297|NCT00002772|Biological|filgrastim|
12067298|NCT00002772|Drug|carboplatin|
12067299|NCT00002772|Drug|carmustine|
12067300|NCT00002772|Drug|cisplatin|
12067301|NCT00002772|Drug|cyclophosphamide|
12067302|NCT00002772|Drug|doxorubicin hydrochloride|
12067303|NCT00002772|Drug|paclitaxel|
12067304|NCT00002772|Drug|tamoxifen citrate|
12067305|NCT00002772|Drug|thiotepa|
12067306|NCT00002772|Procedure|autologous bone marrow transplantation|
12067307|NCT00002772|Procedure|peripheral blood stem cell transplantation|
12067308|NCT00002772|Radiation|radiation therapy|
12067309|NCT00002768|Biological|filgrastim|10 microgram/kg body wt subcutaneously daily beginning on d 14 and con't until peripheral blood collection is completed
12067310|NCT00002768|Drug|busulfan|1 mg/kg PO q 6 hrs for 16 doses on days -7 thru -4.
12067311|NCT00002768|Drug|cytarabine|2000 mg/ sq meter IV over 2 hours q 12 hrs x 8 doses on days 1-4
12067312|NCT00002768|Drug|etoposide|40 mg/kg (total dose) IV cont infusion over 96 hrs on days 1-4 of consolidation therapy and 60 mg/kg IV over 4 hrs on day -3 of transplant
12067313|NCT00002768|Drug|methotrexate|For patients with documented CNS disease at first relapse, 12 mg intrathecal for a total of 6 doses given before and/or after transplantation
12067314|NCT00002768|Procedure|peripheral blood stem cell transplantation|Infusion on Day 0
12067315|NCT00002764|Biological|filgrastim|
12067316|NCT00002764|Drug|doxorubicin hydrochloride|
12067317|NCT00002764|Drug|ifosfamide|
12067318|NCT00002764|Procedure|conventional surgery|
12067319|NCT00002745|Drug|aminocamptothecin|850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response
12067320|NCT00002722|Drug|cisplatin|
12067321|NCT00002722|Drug|fluorouracil|
12067322|NCT00002722|Drug|leucovorin calcium|
12067323|NCT00002595|Drug|toremifene|
12067324|NCT00002595|Procedure|conventional surgery|
12067325|NCT00002583|Drug|cisplatin|50 mg/m2 IV
12067326|NCT00002583|Drug|vinorelbine ditartrate|25 mg/m2 IV
12067327|NCT00002534|Biological|anti-thymocyte globulin|
12067328|NCT00002534|Drug|cyclophosphamide|
12067329|NCT00002534|Drug|cytarabine|
12067330|NCT00002534|Drug|methylprednisolone|
12067331|NCT00002534|Drug|thiotepa|
12067332|NCT00002534|Procedure|allogeneic bone marrow transplantation|
12067333|NCT00002534|Procedure|in vitro-treated bone marrow transplantation|
12067334|NCT00002534|Radiation|low-LET electron therapy|
12067335|NCT00002534|Radiation|low-LET photon therapy|
12067336|NCT00002519|Drug|chemotherapy|
12067337|NCT00002519|Drug|paclitaxel|
12067338|NCT00002519|Radiation|radiation therapy|
12067339|NCT00002501|Biological|filgrastim|
12067340|NCT00002501|Drug|cyclophosphamide|
12067341|NCT00002492|Drug|cisplatin|
12067342|NCT00002492|Drug|doxorubicin hydrochloride|
12067343|NCT00002492|Drug|isolated limb perfusion|
12067344|NCT00002492|Procedure|conventional surgery|
12067345|NCT00002492|Radiation|brachytherapy|
12067346|NCT00002492|Radiation|radiation therapy|
12067347|NCT00002463|Drug|MOPP Regimen|Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP)
12067348|NCT00002463|Drug|Leucovorin Calcium|
12067349|NCT00002463|Drug|Mechlorethamine Hydrochloride|
12067350|NCT00002463|Drug|Methotrexate|
12067351|NCT00002463|Drug|Prednisone|
12067352|NCT00002463|Drug|Procarbazine Hydrochloride|
12067353|NCT00002463|Drug|Vincristine Sulfate|
12067354|NCT00002463|Procedure|Conventional Surgery|
12067355|NCT00081744|Drug|Tigecycline|
12067356|NCT00081731|Drug|Atacand/HCT, Caduet|Atacand/HCT and caduet or optimal medical therapy for hypertension
12067357|NCT00081731|Procedure|GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)|Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
12067358|NCT00081653|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 3 years
12067359|NCT00081653|Drug|ibandronate [Bonviva/Boniva]|100mg po monthly for 3 years
12067360|NCT00019344|Drug|alvocidib|
12067361|NCT00019240|Drug|cidofovir|
12067362|NCT00016900|Drug|liposomal paclitaxel|
12067363|NCT00010010|Drug|exemestane|
12067364|NCT00010010|Drug|goserelin acetate|
12067365|NCT00009828|Drug|leucovorin calcium|
12067366|NCT00009828|Drug|paclitaxel|
12067367|NCT00009828|Drug|tegafur-uracil|
12067368|NCT00081614|Drug|Avastin (bevacizumab)|
12067369|NCT00081614|Drug|Tarceva (erlotinib HCl)|
12067370|NCT00081549|Drug|Aroplatin (Liposomal NDDP, L-NDDP)|
12067371|NCT00081536|Drug|Aroplatin (Liposomal NDDP) in combination with capecitabine|
12067372|NCT00012129|Drug|liposomal annamycin|
12067373|NCT00009815|Drug|etoposide|
12067374|NCT00009815|Drug|leucovorin calcium|
12067375|NCT00009815|Drug|tegafur-uracil|
12067376|NCT00005989|Drug|tipifarnib|
12067377|NCT00005958|Biological|filgrastim|
12067378|NCT00005958|Drug|docetaxel|
12067379|NCT00005958|Drug|gemcitabine hydrochloride|
12067380|NCT00005950|Drug|nelarabine|Given IV
12067381|NCT00005938|Drug|exatecan mesylate|
12067382|NCT00005828|Dietary Supplement|green tea extract|
12067383|NCT00005827|Dietary Supplement|genistein|
12067384|NCT00081640|Drug|PRO 2000/5 Gel (P)|
12067385|NCT00081601|Drug|CEP-701|
12067386|NCT00081588|Drug|TMC114|600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
12067387|NCT00081575|Drug|Tigecycline|
12067388|NCT00081575|Drug|Levofloxacin|
12067389|NCT00081380|Drug|Seroquel®, quetiapine fumarate (atypical antipsychotic)|
12067390|NCT00081380|Drug|lithium (mood stabilizer)|
12067391|NCT00081380|Drug|divalproex (mood stabilizer)|
12067392|NCT00005810|Biological|filgrastim|
12067393|NCT00005810|Drug|carboplatin|
12067394|NCT00005810|Drug|docetaxel|
12067395|NCT00005810|Drug|estramustine phosphate sodium|
12067396|NCT00005809|Procedure|computed tomography|
12067397|NCT00005809|Procedure|diagnostic colonoscopy|
12067398|NCT00005643|Drug|pegylated liposomal doxorubicin hydrochloride|
12067399|NCT00005625|Drug|trabectedin|
12067400|NCT00005608|Drug|leucovorin calcium|
12067401|NCT00005608|Drug|tegafur-uracil|
12067402|NCT00005080|Drug|nelarabine|Given IV
12067403|NCT00005071|Procedure|biopsy|
12067404|NCT00005071|Procedure|bronchoscopy|
12067405|NCT00005071|Procedure|computed tomography|
12067406|NCT00005071|Procedure|quality-of-life assessment|
12067407|NCT00004252|Drug|fluorouracil|
12067408|NCT00004252|Drug|leucovorin calcium|
12067409|NCT00004252|Drug|semaxanib|
12067410|NCT00004229|Biological|recombinant human endostatin|
12067411|NCT00004178|Biological|therapeutic autologous lymphocytes|
12067412|NCT00081510|Drug|Lonafarnib|
12067413|NCT00081510|Drug|Placebo|
12067414|NCT00081510|Drug|anastrozole|
12067415|NCT00081497|Biological|agalsidase beta|1.0 mg/kg every 2 weeks
12067416|NCT00081484|Drug|epoetin alfa or beta|iv or sc, as prescribed
12067417|NCT00081484|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
12067418|NCT00081471|Drug|darbepoetin alfa|0.45 micrograms/kg sc (starting dose) weekly
12067419|NCT00081471|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|0.6 micrograms/kg sc (starting dose) once every 2 weeks
12067420|NCT00004177|Biological|filgrastim|as prescribed by physician
12067421|NCT00004177|Procedure|peripheral blood stem cell transplantation|1-2 weeks from treatment
12067422|NCT00004177|Radiation|indium In 111 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
12067423|NCT00004177|Radiation|yttrium Y 90 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
12067424|NCT00004108|Drug|exatecan mesylate|
12067425|NCT00004107|Biological|filgrastim|as prescribed by physician
12067426|NCT00004107|Procedure|autologous bone marrow transplantation|1-2 weeks before treatment
12067427|NCT00004107|Procedure|peripheral blood stem cell transplantation|1-2 weeks before treatment
12067428|NCT00004107|Radiation|indium In 111 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
12067429|NCT00004107|Radiation|yttrium Y 90 epratuzumab|intravenous infusion over 30 min; single dose
12067430|NCT00004100|Drug|cisplatin|
12067431|NCT00004100|Drug|gemcitabine hydrochloride|
12067432|NCT00004100|Drug|vinorelbine tartrate|
12067433|NCT00004087|Biological|filgrastim|as prescribed by physician
12067434|NCT00004087|Procedure|autologous bone marrow transplantation|1-2 weeks before treatment
12067435|NCT00004087|Procedure|peripheral blood stem cell transplantation|1-2 weeks before treatment
12067436|NCT00004087|Radiation|indium In 111 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
12067437|NCT00004087|Radiation|yttrium Y 90 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
12067438|NCT00004086|Biological|filgrastim|
12067439|NCT00004086|Drug|cisplatin|
12067440|NCT00004086|Drug|cytarabine|
12067441|NCT00004086|Drug|etoposide|
12067442|NCT00004086|Drug|ifosfamide|
12067443|NCT00004086|Procedure|autologous bone marrow transplantation|
12067444|NCT00004086|Procedure|peripheral blood stem cell transplantation|
12067445|NCT00004086|Radiation|indium In 111 LL2 IgG|
12067446|NCT00004086|Radiation|yttrium Y 90 epratuzumab|
12067447|NCT00004085|Biological|filgrastim|as prescribed by physician
12067448|NCT00004085|Procedure|autologous bone marrow transplantation|1-2 weeks prior to treatment
12067449|NCT00004085|Procedure|peripheral blood stem cell transplantation|1-2 weeks prior to treatment
12067450|NCT00004085|Radiation|yttrium Y 90 monoclonal antibody MN-14|intravenous infusion over 30 min, single dose
12067451|NCT00004084|Radiation|indium In 111 LL2 IgG|single dose, intravenous infusion over 30 minutes
12067452|NCT00004084|Radiation|yttrium Y 90 epratuzumab|single dose, intravenous infusion over 30 minutes
12067453|NCT00004048|Biological|filgrastim|
12067454|NCT00004048|Drug|doxorubicin hydrochloride|
12067455|NCT00004048|Procedure|autologous bone marrow transplantation|
12067456|NCT00004048|Procedure|peripheral blood stem cell transplantation|
12067457|NCT00004048|Radiation|indium In 111 monoclonal antibody MN-14|
12067458|NCT00004048|Radiation|yttrium Y 90 monoclonal antibody MN-14|
12067459|NCT00004046|Drug|exatecan mesylate|
12067460|NCT00004045|Drug|exatecan mesylate|
12067461|NCT00004033|Drug|liposomal NDDP|
12067462|NCT00004033|Procedure|therapeutic thoracoscopy|
12067463|NCT00004016|Biological|recombinant interferon gamma|
12067464|NCT00004010|Biological|bleomycin sulfate|
12067465|NCT00004010|Biological|filgrastim|
12067466|NCT00004010|Drug|ABVD regimen|
12067467|NCT00004010|Drug|cyclophosphamide|
12067468|NCT00004010|Drug|dacarbazine|
12067469|NCT00004010|Drug|doxorubicin hydrochloride|
12067470|NCT00004010|Drug|etoposide|
12067471|NCT00004010|Drug|prednisone|
12067472|NCT00004010|Drug|procarbazine hydrochloride|
12067473|NCT00004010|Drug|vinblastine sulfate|
12067474|NCT00004010|Drug|vincristine sulfate|
12067475|NCT00004010|Radiation|radiation therapy|
12067476|NCT00003954|Drug|melphalan|Given IV
12067477|NCT00003954|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous bone marrow or PBSCT
12067478|NCT00003954|Procedure|autologous bone marrow transplantation|Undergo autologous bone marrow or PBSCT
12067479|NCT00003954|Procedure|peripheral blood stem cell transplantation|Undergo autologous bone marrow or PBSCT
12067480|NCT00003954|Radiation|total-body irradiation|Undergo TBI
12067481|NCT00003954|Procedure|peripheral blood stem cell transplantation|Undergo donor PBSCT
12067482|NCT00003954|Drug|cyclosporine|Given IV and PO
12067483|NCT00003954|Drug|mycophenolate mofetil|Given PO
12067484|NCT00003954|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
12067485|NCT00081458|Drug|Placebo|placebo injectable subcutaneously daily into thigh or abdomen
12067486|NCT00081458|Drug|Teduglutide 0.05 mg/kg/d|Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen
12067487|NCT00081458|Drug|Teduglutide 0.1 mg/kg/d|Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen
12067488|NCT00003917|Drug|topotecan hydrochloride|
12067489|NCT00003870|Drug|cyclophosphamide|
12067490|NCT00003870|Drug|methotrexate|
12067491|NCT00003870|Procedure|allogeneic bone marrow transplantation|
12067492|NCT00003870|Radiation|iodine I 131 monoclonal antibody BC8|
12067493|NCT00003870|Radiation|radiation therapy|
12067494|NCT00003834|Drug|fluorouracil|
12067495|NCT00003834|Drug|leucovorin calcium|
12067496|NCT00003834|Drug|oxaliplatin|
12067497|NCT00003824|Drug|cephalexin|500 mg oral bid for 3 days starting the night before resection
12067498|NCT00003824|Procedure|surgical procedure|
12067499|NCT00003824|Drug|Ciprofloxacin|500 mg oral bid for 3 days starting the night before resection
12067500|NCT00003809|Biological|cetuximab|
12067501|NCT00003809|Drug|cisplatin|
12067502|NCT00003719|Drug|irinotecan hydrochloride|
12067503|NCT00003718|Drug|temozolomide|
12067504|NCT00003717|Drug|estramustine phosphate sodium|
12067505|NCT00003717|Drug|paclitaxel|
12067506|NCT00003674|Drug|dalteparin|
12067507|NCT00003674|Drug|standard therapy|
12067508|NCT00003493|Drug|dexamethasone|
12067509|NCT00003493|Drug|pegylated liposomal doxorubicin hydrochloride|
12067510|NCT00003493|Drug|vincristine sulfate|
12067511|NCT00003307|Drug|amifostine trihydrate|
12067512|NCT00003307|Radiation|radiation therapy|
12067513|NCT00003283|Drug|octreotide acetate|
12067514|NCT00003283|Drug|prednisone|
12067515|NCT00003235|Drug|carboplatin|
12067516|NCT00003235|Drug|paclitaxel|
12067517|NCT00003235|Radiation|radiation therapy|
12067518|NCT00003209|Biological|bleomycin sulfate|
12067519|NCT00003209|Drug|cisplatin|
12067524|NCT00003209|Drug|vinblastine sulfate|
12067525|NCT00003209|Drug|vindesine|
12067526|NCT00003209|Radiation|radiation therapy|
12067527|NCT00003125|Biological|ALVAC-CEA vaccine|
12067528|NCT00003125|Biological|aldesleukin|
12067529|NCT00003125|Biological|sargramostim|
12067530|NCT00003125|Biological|vaccinia-CEA vaccine|
12067531|NCT00003080|Drug|endocrine-modulating drug therapy|
12067532|NCT00003080|Drug|melphalan|
12067533|NCT00003080|Drug|mitoxantrone hydrochloride|
12067534|NCT00003080|Drug|tamoxifen citrate|
12067535|NCT00003080|Drug|thiotepa|
12067536|NCT00003080|Procedure|peripheral blood stem cell transplantation|
12067537|NCT00003061|Drug|cytarabine|
12067538|NCT00003061|Drug|methotrexate|
12067539|NCT00003061|Radiation|radiation therapy|
12067540|NCT00003032|Biological|filgrastim|
12067541|NCT00003032|Drug|cisplatin|
12067542|NCT00003032|Drug|cyclophosphamide|
12067543|NCT00003032|Drug|mitoxantrone hydrochloride|
12067544|NCT00003032|Drug|tamoxifen citrate|
12067545|NCT00003010|Drug|marimastat|
12067546|NCT00021398|Drug|fluorouracil|
12067547|NCT00021398|Drug|leucovorin calcium|
12067548|NCT00021398|Procedure|conventional surgery|
12067549|NCT00021398|Radiation|radiation therapy|
12067550|NCT00021281|Drug|FOLFIRI regimen|
12067551|NCT00021281|Drug|fluorouracil|
12067552|NCT00021281|Drug|irinotecan hydrochloride|
12067553|NCT00021281|Drug|leucovorin calcium|
12067554|NCT00021281|Drug|semaxanib|
12067555|NCT00021151|Biological|alemtuzumab|
12067556|NCT00021008|Drug|picoplatin|
12067557|NCT00020774|Drug|gemcitabine hydrochloride|
12067558|NCT00020774|Drug|lonafarnib|
12067559|NCT00020774|Procedure|conventional surgery|
12067560|NCT00019552|Drug|irofulven|
12067561|NCT00019474|Biological|filgrastim|
12067562|NCT00019474|Biological|recombinant interferon alfa|
12067563|NCT00019474|Drug|fluorouracil|
12067564|NCT00019474|Drug|hydroxyurea|
12067565|NCT00019318|Drug|romidepsin|
12067566|NCT00019123|Drug|thalidomide|
12067567|NCT00014391|Biological|palivizumab|
12067568|NCT00014391|Drug|ribavirin|
12067569|NCT00012311|Biological|filgrastim|
12067570|NCT00012311|Drug|CMF regimen|
12067571|NCT00012311|Drug|carboplatin|
12067572|NCT00012311|Drug|cyclophosphamide|
12067573|NCT00012311|Drug|docetaxel|
12067574|NCT00012311|Drug|doxorubicin hydrochloride|
12067575|NCT00012311|Drug|etoposide|
12067576|NCT00012311|Drug|fluorouracil|
12067577|NCT00012311|Drug|ifosfamide|
12067578|NCT00012311|Drug|methotrexate|
12067579|NCT00012311|Drug|thiotepa|
12067580|NCT00012311|Procedure|peripheral blood stem cell transplantation|
12067581|NCT00010283|Drug|beclomethasone dipropionate|
12067582|NCT00007943|Drug|gemcitabine hydrochloride|
12067583|NCT00006045|Biological|lintuzumab|
12067584|NCT00006045|Drug|cytarabine|
12067585|NCT00006045|Drug|etoposide|
12067586|NCT00006045|Drug|mitoxantrone hydrochloride|
12067587|NCT00005875|Drug|rubitecan|
12067588|NCT00005874|Drug|rubitecan|
12067589|NCT00005873|Drug|rubitecan|
12067590|NCT00002708|Procedure|surgical procedure|
12067591|NCT00002708|Radiation|radiation therapy|
12067592|NCT00002708|Radiation|stereotactic radiosurgery|
12067593|NCT00081406|Behavioral|Individual Child CBT|
12067594|NCT00081406|Behavioral|Family CBT|
12067595|NCT00081406|Behavioral|Education/Support/Attention|
12067596|NCT00081367|Behavioral|CBT|Participants will receive ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed.
12067597|NCT00081367|Behavioral|Standard care alone|Participants will receive standard care for suicide prevention.
12067598|NCT00081328|Drug|Metformin|capsule, 1000 mg bid
12067599|NCT00081328|Drug|Rosiglitazone|capsule, 4 mg bid
12067600|NCT00081328|Behavioral|Lifestyle Program|a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study
12067601|NCT00005872|Drug|rubitecan|
12067602|NCT00005833|Drug|R115777|300mg P.O. BID.
12067603|NCT00005820|Drug|nitrocamptothecin|
12067604|NCT00005801|Biological|therapeutic allogeneic lymphocytes|
12067605|NCT00005801|Procedure|peripheral blood stem cell transplantation|
12067606|NCT00005801|Radiation|radiation therapy|
12067607|NCT00005077|Drug|oxaliplatin|
12067608|NCT00005066|Drug|O6-benzylguanine|
12067609|NCT00005066|Drug|carmustine|
12067610|NCT00005061|Biological|bevacizumab|
12067611|NCT00005058|Procedure|ultrasound imaging|
12067612|NCT00005040|Drug|arsenic trioxide|
12067613|NCT00004885|Drug|FOLFIRI regimen|
12067614|NCT00004885|Drug|fluorouracil|
12067615|NCT00004885|Drug|irinotecan hydrochloride|
12067616|NCT00004885|Drug|leucovorin calcium|
12067617|NCT00004860|Drug|leucovorin calcium|
12067618|NCT00004860|Drug|tegafur-uracil|
12067619|NCT00004238|Drug|pralatrexate|
12067620|NCT00004166|Drug|amifostine trihydrate|
12067621|NCT00004166|Procedure|quality-of-life assessment|
12067622|NCT00004137|Biological|filgrastim|
12067623|NCT00004137|Drug|carboplatin|
12067624|NCT00004137|Drug|paclitaxel|
12067625|NCT00004137|Drug|topotecan hydrochloride|
12067626|NCT00004102|Drug|FOLFOX regimen|
12067627|NCT00004102|Drug|fluorouracil|
12067628|NCT00004102|Drug|leucovorin calcium|
12067629|NCT00004102|Drug|oxaliplatin|
12067632|NCT00004082|Drug|gemcitabine hydrochloride|
12067633|NCT00004002|Drug|bortezomib|
12067634|NCT00003911|Radiation|stereotactic radiosurgery|
12067635|NCT00003840|Biological|DTGM fusion protein|
12067636|NCT00081315|Drug|Amifostine|
12067637|NCT00005943|Biological|aldesleukin|
12067638|NCT00005943|Biological|staphylococcal enterotoxin B|
12067639|NCT00003754|Drug|cyclophosphamide|
12067640|NCT00003754|Drug|thalidomide|
12067641|NCT00003710|Drug|irinotecan hydrochloride|Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.
12067642|NCT00003710|Drug|mitomycin C|Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.
12067643|NCT00003692|Procedure|therapeutic thoracoscopy|
12067644|NCT00003692|Procedure|video-assisted surgery|
12067645|NCT00003642|Drug|cisplatin|
12067646|NCT00003642|Drug|fluorouracil|
12067647|NCT00003642|Radiation|radiation therapy|
12067648|NCT00003446|Drug|fluorouracil|
12067649|NCT00003446|Drug|leucovorin calcium|
12067650|NCT00003446|Drug|trimetrexate glucuronate|
12067651|NCT00003376|Drug|carboplatin|
12067652|NCT00003376|Drug|cisplatin|
12067653|NCT00003376|Drug|doxorubicin hydrochloride|
12067654|NCT00003376|Drug|methotrexate|
12067655|NCT00003376|Drug|paclitaxel|
12067656|NCT00003376|Drug|vinblastine|
12067657|NCT00003316|Drug|gemcitabine hydrochloride|
12067658|NCT00003301|Drug|irinotecan hydrochloride|
12067659|NCT00003232|Drug|clodronate disodium|
12067660|NCT00003232|Drug|mitoxantrone hydrochloride|
12067661|NCT00003232|Drug|prednisone|
12067662|NCT00003232|Procedure|quality-of-life assessment|
12067663|NCT00081302|Biological|cetuximab|
12067664|NCT00081302|Drug|carboplatin|
12067665|NCT00081302|Drug|paclitaxel|
12067666|NCT00081302|Radiation|radiation therapy|
12067667|NCT00081289|Radiation|Radiation Therapy|Pelvic radiation therapy given once daily 5 days a week for 6 weeks, 45 Gy in 25 fractions + boost of 5.4 Gy in 3 fractions for a total dose of 50.4 Gy.
12067668|NCT00081289|Drug|Capecitabine 1650 mg/m^2/day|825 mg/m^2 q12 hours (1650 mg/m^2/day) orally 5 days per week during radiotherapy.
12067669|NCT00081289|Drug|Capecitabine 1200 mg/m^2/day|600 mg/m^2 q12 hours(1200 mg/m^2/day) orally 5 days per week during radiotherapy.
12067670|NCT00081289|Drug|Irinotecan|50mg/m^2 IV over 1 hour on days 1, 8, 22, and 29
12067671|NCT00081289|Drug|Oxaliplatin|50mg/m^2 IV over 2 hours on days 1, 8, 15, 22, and 29
12067672|NCT00081289|Procedure|Surgery|All patients will undergo surgery four to eight weeks following the completion of radiation therapy. The choice of procedure abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis is at the discretion of the surgeon.
12067673|NCT00081289|Drug|Folinic Acid|400 mg/m^2 IV over 2 hours Day 1 (postoperatively) ,every 14 days, for nine 14-day cycles.
12067674|NCT00081289|Drug|Fluorouracil|"5-fluorouracil bolus 400 mg/m^2 IV push Day 1 (postoperatively), every 14 days, for nine 14-day cycles.
~5-fluorouracil infusion 2400 mg/m^2 IV continuous infusion over 46 hours, beginning day 1, every 14 days, for nine 14-day cycles."
12067675|NCT00081289|Drug|Oxaliplatin|85 mg/m^2 IV over 2 hours Day 1 (postoperatively), every 14 days, for nine 14-day cycles.
12067676|NCT00081276|Drug|triapine|Given IV
12067677|NCT00081276|Drug|cisplatin|Given IV
12067678|NCT00081276|Other|laboratory biomarker analysis|Correlative studies
12067679|NCT00081263|Drug|Celecoxib|Given orally
12067680|NCT00081263|Other|Laboratory Biomarker Analysis|Correlative studies
12067681|NCT00081263|Other|Placebo|Given orally
12067682|NCT00081250|Dietary Supplement|creatine monohydrate|Given orally
12067683|NCT00081250|Other|placebo|Given orally
12067684|NCT00081237|Drug|OSI-7904L|
12067685|NCT00081237|Drug|oxaliplatin|
12067686|NCT00081224|Drug|capecitabine|
12067687|NCT00081224|Drug|celecoxib|
12067688|NCT00081224|Radiation|radiation therapy|
12067689|NCT00081224|Procedure|surgery|
12067690|NCT00081211|Biological|PV701|Given intratumorally
12067691|NCT00081172|Radiation|lutetium Lu 177 monoclonal antibody J591|
12067692|NCT00081159|Drug|Doxorubicin hydrochloride|Doxorubicin 20 mg/m^2 is administered intravenously either over 15 to 30 minutes via a peripheral line or over 24 hours via a central line on days 1, 8, and 15 every 28 days for 2 cycles.
12067693|NCT00081159|Drug|Goserelin acetate|
12067694|NCT00081159|Drug|Leuprolide acetate|
12067695|NCT00081159|Drug|Zoledronic acid|4 mg given intravenously over 15 minutes every 28 days for a total of 6 doses.
12067696|NCT00081159|Procedure|orchiectomy|
12067697|NCT00081159|Radiation|strontium chloride Sr|1 dose of strontium-89 (4 millicurie (mCi) total dose) administered intravenously on the first day of treatment
12067698|NCT00081133|Drug|arsenic trioxide|
12067699|NCT00081133|Drug|imatinib mesylate|
12067700|NCT00081107|Drug|epothilone D|
12067701|NCT00081094|Procedure|18F-Fluorodeoxyglucose-PET (FDG-PET)|
12067702|NCT00081094|Procedure|11Carbon-Acetate-PET|
12067703|NCT00081068|Biological|alemtuzumab|
12067704|NCT00081055|Biological|autologous expanded mesenchymal stem cells OTI-010|
12067705|NCT00081055|Drug|busulfan|
12067706|NCT00081055|Drug|cyclophosphamide|
12067707|NCT00081055|Drug|cyclosporine|
12067709|NCT00081055|Procedure|peripheral blood stem cell transplantation|
12067710|NCT00081055|Radiation|radiation therapy|
12067711|NCT00081042|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12067712|NCT00081029|Procedure|management of therapy complications|
12067713|NCT00081029|Radiation|radiation therapy|
12067714|NCT00081003|Genetic|gene expression analysis|
12067715|NCT00081003|Genetic|protein expression analysis|
12067716|NCT00081003|Other|cytology specimen collection procedure|
12067717|NCT00081003|Other|laboratory biomarker analysis|
12067718|NCT00081003|Other|physiologic testing|
12067719|NCT00081003|Procedure|breast duct lavage|
12067720|NCT00081003|Procedure|endoscopic biopsy|
12067721|NCT00081003|Procedure|study of high risk factors|
12067722|NCT00080990|Drug|alvocidib|Given IV
12067723|NCT00080990|Drug|fluorouracil|Given IV
12067724|NCT00080990|Drug|oxaliplatin|Given IV
12067725|NCT00080990|Drug|leucovorin calcium|Given IV
12067726|NCT00080977|Biological|aldesleukin|
12067727|NCT00080951|Drug|fluorouracil|
12067728|NCT00080951|Drug|irinotecan hydrochloride|
12067729|NCT00080951|Drug|leucovorin calcium|
12067730|NCT00080951|Drug|oxaliplatin|
12067731|NCT00080938|Drug|Temozolomide|Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles.
12067732|NCT00080938|Radiation|Radiation therapy|Standard whole brain radiation therapy 30 Gy in ten fractions.
12067733|NCT00080925|Biological|filgrastim|
12067734|NCT00080925|Biological|graft-versus-tumor induction therapy|
12067735|NCT00080925|Biological|rituximab|
12067736|NCT00080925|Biological|therapeutic allogeneic lymphocytes|
12067737|NCT00080925|Drug|cyclophosphamide|
12067738|NCT00080925|Drug|cyclosporine|
12067739|NCT00080925|Drug|cytarabine|
12067740|NCT00080925|Drug|doxorubicin hydrochloride|
12067741|NCT00080925|Drug|etoposide|
12067742|NCT00080925|Drug|fludarabine phosphate|
12067743|NCT00080925|Drug|prednisone|
12067744|NCT00080925|Drug|vincristine sulfate|
12067745|NCT00080925|Procedure|peripheral blood stem cell transplantation|
12067746|NCT00080912|Radiation|radiation therapy|Given in a single fraction or multiple fractions
12067747|NCT00080899|Drug|fenretinide|Given orally
12067748|NCT00080899|Other|laboratory biomarker analysis|Correlative studies
12067749|NCT00080886|Biological|rituximab|
12067750|NCT00080886|Drug|carmustine|
12067751|NCT00080886|Drug|cytarabine|
12067752|NCT00080886|Drug|etoposide|
12067753|NCT00080886|Drug|melphalan|
12067754|NCT00080886|Procedure|autologous bone marrow transplantation|
12067755|NCT00080886|Procedure|peripheral blood stem cell transplantation|
12067756|NCT00080873|Drug|Traumeel S|
12067757|NCT00080873|Other|Placebo|
12067758|NCT00080860|Genetic|microarray analysis|
12067759|NCT00080860|Other|immunohistochemistry staining method|
12067760|NCT00080860|Procedure|conventional surgery|
12067761|NCT00080860|Procedure|lymphangiography|
12067762|NCT00080860|Procedure|radionuclide imaging|
12067763|NCT00080860|Procedure|sentinel lymph node biopsy|
12067764|NCT00080860|Radiation|technetium Tc 99m sulfur colloid|
12067765|NCT00080847|Biological|oblimersen sodium|Given IV
12067766|NCT00080847|Biological|rituximab|Given IV
12067767|NCT00080847|Drug|cyclophosphamide|Given IV
12067768|NCT00080847|Drug|doxorubicin hydrochloride|Given IV
12067769|NCT00080847|Drug|vincristine sulfate|Given IV
12067770|NCT00080847|Drug|prednisone|Given orally
12067771|NCT00080847|Other|laboratory biomarker analysis|Correlative studies
12067772|NCT00080834|Drug|DJ-927|
12067773|NCT00080808|Drug|Alprostadil (E1)|Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
12067774|NCT00080808|Drug|Papaverine|Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
12067775|NCT00080808|Drug|Phentolamine mesylate|Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
12067776|NCT00080808|Drug|Sildenafil citrate|Oral sildenafil as needed
12067777|NCT00080808|Procedure|conventional surgery|Unilateral cavernous nerve sparing radical retropubic prostatectomy
12067778|NCT00080795|Biological|filgrastim|
12067779|NCT00080795|Drug|cisplatin|
12067780|NCT00080795|Drug|doxorubicin hydrochloride|
12067781|NCT00080795|Drug|gemcitabine hydrochloride|
12067782|NCT00080795|Drug|ifosfamide|
12067783|NCT00080795|Procedure|conventional surgery|
12067784|NCT00080795|Procedure|neoadjuvant therapy|
12067785|NCT00080782|Drug|Celecoxib|Oral celecoxib twice daily in the absence of disease progression.
12067786|NCT00080782|Drug|Doxorubicin Hydrochloride|By vein (IV) over 30 minutes on days 1, 8, 15, and 22
12067787|NCT00080782|Radiation|Strontium chloride Sr 89|IV on day 1
12067788|NCT00080756|Biological|therapeutic estradiol|0.35mg/100ul per day as a nasal spray
12067789|NCT00080756|Drug|deslorelin|1mg/100ul per day as a nasal spray
12067790|NCT00080756|Drug|therapeutic testosterone|0.275mg/100ul per day as a nasal spray
12067791|NCT00080756|Procedure|therapeutic conventional surgery|Undergo risk reduction mastectomy
12067792|NCT00080756|Other|active surveillance|Undergo continued surveillance
12067793|NCT00080756|Procedure|quality-of-life assessment|Ancillary studies
12067794|NCT00080756|Other|laboratory biomarker analysis|Correlative studies
12067795|NCT00080743|Drug|gefitinib|250 mg po once daily
12067796|NCT00080743|Drug|tamoxifen citrate|20 mg po once daily
12067797|NCT00080743|Drug|Placebo|One pill po once daily
12067798|NCT00080678|Drug|Docetaxel|
12067800|NCT00080665|Drug|docetaxel|Docetaxel (15-30 mg/m2, IV, weekly on days 1, 8, and 15) each 28 day cycle
12067801|NCT00080665|Drug|imatinib mesylate|Imatinib mesylate (400-600 mg, oral, once daily) each 28 day cycle
12067802|NCT00080639|Other|physiologic testing|
12067803|NCT00080639|Procedure|study of high risk factors|
12067804|NCT00080626|Biological|pegfilgrastim|6 mg injection on day 1 of each cycle
12067805|NCT00080626|Drug|docetaxel|100 mg per meter-squared, every 14 days for 4 cycles
12067806|NCT00080626|Procedure|conventional surgery|lumpectomy or mastectomy at end of treatment
12067807|NCT00080626|Procedure|neoadjuvant therapy|treatment prior to definitive breast surgery
12067808|NCT00080613|Drug|exemestane|
12067809|NCT00080613|Procedure|adjuvant therapy|
12067810|NCT00080613|Procedure|aromatase inhibition|
12067811|NCT00080613|Procedure|conventional surgery|
12067812|NCT00080613|Procedure|endocrine therapy|
12067813|NCT00080613|Procedure|hormone therapy|
12067814|NCT00080613|Procedure|neoadjuvant therapy|
12067815|NCT00080613|Procedure|surgery|
12067816|NCT00080574|Procedure|Skin Biopsy|
12067817|NCT00080535|Biological|LMB-2|30 micrograms/kg every other day (QOD) x 3 every 4 weeks
12067818|NCT00080522|Behavioral|Monitoring by HIV-trained primary care nurses|
12067819|NCT00080522|Behavioral|Community-based directly observed therapy (DOT)|
12067820|NCT00080522|Drug|stavudine|
12067821|NCT00080522|Drug|lamivudine|
12067822|NCT00080522|Drug|efavirenz|
12067823|NCT00080522|Drug|zidovudine|
12067824|NCT00080522|Drug|didanosine|
12067825|NCT00080522|Drug|lopinavir/ritonavir|
12067826|NCT00080509|Drug|KOS-862|
12067827|NCT00080496|Drug|Tigecycline|
12067828|NCT00080496|Drug|Imipenem|
12067829|NCT00080496|Drug|Cilastatin|
12067830|NCT00003176|Drug|carmustine|
12067831|NCT00003176|Drug|temozolomide|
12067832|NCT00003156|Drug|topotecan hydrochloride|
12067833|NCT00003132|Drug|bryostatin 1|
12067834|NCT00003132|Drug|cisplatin|
12067835|NCT00003110|Biological|bleomycin sulfate|Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve complete remission receive 2 more cycles. Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs.
12067836|NCT00002997|Procedure|cryosurgery|
12067837|NCT00080483|Drug|Testosterone plus somatropin|AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years
12067838|NCT00080483|Drug|testosterone|AndroGel transdermally 5 g a day for two years
12067839|NCT00024063|Drug|orantinib|
12067840|NCT00003107|Biological|recombinant interleukin-12|
12067841|NCT00003103|Biological|oblimersen sodium|
12067842|NCT00003103|Drug|docetaxel|
12067843|NCT00003012|Drug|CMF regimen|
12067844|NCT00003012|Drug|cyclophosphamide|
12067845|NCT00003012|Drug|epirubicin hydrochloride|
12067846|NCT00003012|Drug|fluorouracil|
12067847|NCT00003012|Drug|methotrexate|
12067848|NCT00002987|Biological|bleomycin sulfate|
12067849|NCT00002987|Drug|cyclophosphamide|
12067850|NCT00002987|Drug|doxorubicin hydrochloride|
12067851|NCT00002987|Drug|etoposide|
12067852|NCT00002987|Drug|prednisolone|
12067853|NCT00002987|Drug|vincristine sulfate|
12067854|NCT00002987|Radiation|radiation therapy|
12067855|NCT00002814|Biological|filgrastim|
12067856|NCT00002814|Drug|paclitaxel|
12067857|NCT00002814|Drug|topotecan hydrochloride|
12067858|NCT00002774|Drug|Tirapazamine|"Tirapazamine is a benzotriazine with selective cytotoxicity for hypoxic cells. Under hypoxic conditions, it undergoes a 1-electron reduction to form a cytotoxic free radical that poisons topoisomerase II and causes DNA breaks, chromosomal aberrations, and cell death.
~Tirapazamine was administered on Days 1 and 22 prior to the administration of neoadjuvant cisplatin and on Days 43, 45, 47, 71, 73, and 75 within 1 or 2 hours prior to each simultaneous cisplatin dose.
~Tirapazamine dose was as follows:
~Level 1 - 300 mg/m2 during the induction phase and 160 mg/m2 during the simultaneous phase (n = 4)
~Level 2 - 330 mg/m2 during the induction phase and 260 mg/m2 during the simultaneous phase (n = 4)
~Level 3 - 300 mg/m2 during the induction phase and 220 mg/m2 during the simultaneous phase (n = 25)"
12067859|NCT00002774|Drug|Cisplatin|The simultaneous chemoradiotherapy (CRT) regimen included cisplatin 20 mg/m2 administered 3 times per week.
12067860|NCT00002774|Drug|5-fluorouracil|"100 mg/m2 per day on Days 1 and 22, and continuous infusion (CI) 5-FU at a dose of 1000 mg/m2 per day for 120 hours per cycle starting on Days 1 and 22.
~The simultaneous chemoradiotherapy (CRT) regimen included continuous infusion (CI) 5-FU 600 mg/m2 per day for 96 hours per cycle in Weeks 1 and 5 of RT."
12067861|NCT00002774|Radiation|Radiotherapy (RT)|"During the CRT regimen, RT was given within 3 hrs of the tirapazamine infusion. The dose for the parallel opposed fields was 2 Gy/fraction/day given 5 dys/week up to a total dose of 66-70 Gy at the target lesion. The dose to the supraclavicular region was 50 Gy at a depth of 3 cm, delivered in 25 fractions. Supervoltage photons (≥4 megavolts) were used to treat both locations.
~After 50 Gy were delivered to the primary site and regional lymph nodes, all sites were reassessed for clinical response by physical exam, direct fiber optic evaluation, and radiographic imaging (CT or MRI).
~Subjects with a CR at both the primary site and the neck completed RT treatment to a total dose ≥66 Gy to the primary site and the involved lymph node(s). Subjects with a CR at the primary site but a partial response (PR) at the neck completed RT treatment to the primary site followed by neck dissection. Subjects with a PR at the primary site stopped radiation at 50 Gy and underwent salvage surgery."
12067862|NCT00002714|Biological|bleomycin sulfate|
12067863|NCT00002714|Drug|Stanford V regimen|
12067864|NCT00002714|Drug|doxorubicin hydrochloride|
12067865|NCT00002714|Drug|etoposide|
12067866|NCT00002714|Drug|mechlorethamine hydrochloride|
12067867|NCT00002714|Drug|prednisone|
12067868|NCT00002714|Drug|vinblastine sulfate|
12067869|NCT00002714|Drug|vincristine sulfate|
12067870|NCT00002714|Radiation|radiation therapy|
12067874|NCT00002600|Procedure|autologous bone marrow transplantation|
12067875|NCT00002600|Procedure|peripheral blood stem cell transplantation|
12067876|NCT00002525|Drug|fluorouracil|"Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5"
12067877|NCT00002525|Drug|leucovorin calcium|given after surgery at dose of 20mg/m^2 IV push on days 1-5
12067878|NCT00002494|Drug|cyclophosphamide|
12067879|NCT00002494|Drug|cytarabine|
12067880|NCT00002494|Drug|dexamethasone|
12067881|NCT00002494|Drug|doxorubicin hydrochloride|
12067882|NCT00002494|Drug|etoposide|
12067883|NCT00002494|Drug|ifosfamide|
12067884|NCT00002494|Drug|leucovorin calcium|
12067885|NCT00002494|Drug|mesna|
12067886|NCT00002494|Drug|methotrexate|
12067887|NCT00002494|Drug|prednisone|
12067888|NCT00002494|Drug|therapeutic hydrocortisone|
12067889|NCT00002494|Drug|vincristine sulfate|
12067890|NCT00002494|Radiation|low-LET cobalt-60 gamma ray therapy|
12067891|NCT00002494|Radiation|low-LET photon therapy|
12067892|NCT00080470|Device|bion|battery powered microstimulator
12067893|NCT00080457|Drug|sitaxsentan sodium|
12067894|NCT00023816|Drug|carbendazim|
12067895|NCT00022386|Biological|epoetin alfa|
12067896|NCT00022386|Procedure|quality-of-life assessment|
12067897|NCT00022256|Drug|motexafin gadolinium|
12067898|NCT00022256|Radiation|radiation therapy|
12067899|NCT00020605|Drug|naloxone hydrochloride|
12067900|NCT00020540|Biological|recombinant CD40-ligand|
12067901|NCT00020540|Biological|recombinant flt3 ligand|
12067902|NCT00019071|Drug|chemotherapy|
12067903|NCT00019071|Drug|cladribine|
12067904|NCT00019071|Radiation|radiation therapy|
12067905|NCT00019058|Drug|chemotherapy|
12067906|NCT00019058|Drug|hydroxyurea|
12067907|NCT00019058|Drug|pentoxifylline|
12067908|NCT00019058|Radiation|radiation therapy|
12067909|NCT00016042|Biological|lymphokine-activated killer cells|
12067910|NCT00016042|Biological|recombinant interferon alfa|
12067911|NCT00016042|Biological|sargramostim|
12067912|NCT00016042|Drug|fluorouracil|
12067913|NCT00014573|Biological|aldesleukin|
12067914|NCT00014573|Biological|autologous tumor cell vaccine|
12067915|NCT00014573|Biological|filgrastim|
12067916|NCT00014573|Biological|sargramostim|
12067917|NCT00014573|Biological|therapeutic autologous lymphocytes|
12067918|NCT00014573|Drug|carmustine|
12067919|NCT00014573|Drug|cisplatin|
12067920|NCT00014573|Drug|cyclophosphamide|
12067921|NCT00014573|Drug|paclitaxel|
12067922|NCT00014573|Procedure|autologous bone marrow transplantation|
12067923|NCT00014573|Procedure|conventional surgery|
12067924|NCT00014573|Procedure|peripheral blood stem cell transplantation|
12067925|NCT00080444|Drug|aprepitant|aprepitant capsules
12067926|NCT00080444|Drug|ondansetron|ondansetron IV preparation
12067927|NCT00080444|Drug|dexamethasone|dexamethasone tablets
12067928|NCT00080444|Drug|placebo to aprepitant|Matching placebo to aprepitant capsules
12067929|NCT00080444|Drug|placebo to dexamethasone|Matching placebo to dexamethasone tablets
12067930|NCT00080444|Drug|rescue medication|Participants are allowed to take rescue medication throughout for nausea or vomiting. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, domperidone, H1-receptor antagonist, and piperazine derivatives.
12067931|NCT00080418|Drug|Liposome Entrapped Paclitaxel Easy to Use|
12067932|NCT00080405|Drug|Bortezomib|
12067933|NCT00009841|Biological|EGFR antisense DNA|
12067934|NCT00009841|Biological|growth factor antagonist therapy|
12067935|NCT00009841|Drug|DC-cholesterol liposome|
12067936|NCT00007813|Biological|filgrastim|
12067937|NCT00007813|Drug|carboplatin|
12067938|NCT00007813|Drug|cyclophosphamide|
12067939|NCT00007813|Drug|etoposide|
12067940|NCT00007813|Procedure|autologous bone marrow transplantation|
12067941|NCT00007813|Procedure|peripheral blood stem cell transplantation|
12067942|NCT00006487|Drug|cisplatin|"During induction: 50 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
~During consolidation: 60 mg/m2, IV on Day 1 only at approximately Week 11, Week 14. 1 hour infusion."
12067943|NCT00006487|Drug|etoposide|"During induction: 50 mg/m2/day, IV on Days 1 - 5, 29 - 33. 1 hour infusion
~During consolidation: 120 mg/m2, IV on Days 1, 2 and 3 at approximately Week 11, Week 14. 1 hour infusion."
12067944|NCT00006487|Drug|tirapazamine|"During induction:
~Phase I low dose: 260 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
~Phase II high dose: 330 mg/m2/day, IV on Days 1, 8, 29, 36 1 hour infusion
~During consolidation:
~330 mg/ m2, IV Day 1 only at approximately Week 11, Week 14. 1 hour infusion."
12067945|NCT00006487|Radiation|radiation therapy|Radiotherapy should begin within 1 - 3 hours after completion of TPZ infusion on Day 1 of Cycle 1 of induction chemotherapy as outlined above. Computed tomography based treatment planning is strongly recommended.The primary tumor, adjacent mediastinum and other targeted lymph nodes shall receive 4,500 cGy in 25 fractions, five days/week at 180 cGy daily. A 1,600 cGy boost to areas of gross disease will be delivered through reduced off-spinal cord fields in eight fractions, five days/week at 200 cGy daily.
12067946|NCT00006458|Radiation|indium In 111 monoclonal antibody MN-14|
12067947|NCT00006458|Radiation|yttrium Y 90 monoclonal antibody MN-14|
12067948|NCT00006376|Drug|chemotherapy|
12067949|NCT00006376|Drug|tipifarnib|
12067950|NCT00006371|Drug|aminoglutethimide|
12067951|NCT00006371|Drug|ketoconazole|
12067952|NCT00006371|Drug|therapeutic hydrocortisone|
12067953|NCT00006370|Radiation|yttrium Y 90-edotreotide|
12067954|NCT00006369|Drug|ERA-923|
12067955|NCT00006368|Radiation|yttrium Y 90-edotreotide|
12067956|NCT00006052|Drug|imatinib mesylate|
12067960|NCT00006032|Drug|topotecan hydrochloride|
12067961|NCT00006032|Procedure|peripheral blood stem cell transplantation|
12067962|NCT00006031|Procedure|Needle localized breast biopsy with specimen x-ray|
12067963|NCT00006031|Procedure|Low dose radioactive seed followed by surgery and mammogram|either iodine I 125 or palladium Pd 103
12067964|NCT00005948|Biological|aldesleukin|
12067965|NCT00005948|Biological|recombinant interferon alfa|
12067966|NCT00005948|Biological|sargramostim|
12067967|NCT00005948|Drug|busulfan|
12067968|NCT00005948|Procedure|peripheral blood stem cell transplantation|
12067969|NCT00005860|Drug|floxuridine|
12067970|NCT00005860|Drug|leucovorin calcium|
12067971|NCT00005860|Drug|oxaliplatin|
12067972|NCT00005799|Drug|fludarabine phosphate|Given IV
12067973|NCT00005799|Radiation|total-body irradiation|Undergo low-dose TBI
12067974|NCT00005799|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative HSCT
12067975|NCT00005799|Procedure|allogeneic bone marrow transplantation|Undergo nonmyeloablative allogeneic bone marrow transplantation
12067976|NCT00005799|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
12067977|NCT00005799|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
12067978|NCT00005799|Drug|cyclosporine|Given PO
12067979|NCT00005799|Drug|mycophenolate mofetil|Given PO
12067980|NCT00005799|Other|pharmacological study|Correlative studies
12067981|NCT00005799|Other|laboratory biomarker analysis|Correlative studies
12067982|NCT00005798|Drug|Carboplatin|Carboplatin will be given at a dose of 267 mg/m2 in D5 W IV over one hour daily on days -6, -5, and -4. (Total dose 800 mg/m2)
12067983|NCT00005798|Drug|Cyclophosphamide|Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 6000 mg/m2)
12067984|NCT00005798|Drug|Thiotepa|Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 500 mg/m2 )
12067985|NCT00005628|Biological|vitespen|
12067986|NCT00005618|Drug|arsenic trioxide|
12067987|NCT00005615|Biological|Interferon alfa|Interferon alfa as outlined in treatment arm.
12067988|NCT00005615|Radiation|Radiation therapy|Radiation therapy as outlined in treatment arm.
12067989|NCT00005577|Drug|gemcitabine hydrochloride|
12067990|NCT00005097|Drug|Polyphenon E and Placebo|Areas of sun damaged skin with actinic keratoses to be treated will be mapped and photographed on patient's bilateral arms. One of the patient's arms will be assigned to be treated with topical Polyphenon E, the patient's other arm with placebo vehicle in a random, double blind manner. The patient's arm treatment areas will receive daily applications of a premeasured amount of drug or placebo. Patients will be seen every other week for 12 weeks to check for effects of the applications and monitor for compliance or possible side effects.
12067991|NCT00005068|Drug|fluorouracil|
12067992|NCT00005068|Drug|irinotecan hydrochloride|
12067993|NCT00005068|Drug|leucovorin calcium|
12067994|NCT00005068|Drug|oxaliplatin|
12067995|NCT00003864|Drug|carboplatin|
12067996|NCT00003864|Drug|docetaxel|
12067997|NCT00080431|Drug|Daclizumab|
12067998|NCT00005031|Drug|irofulven|
12067999|NCT00004248|Biological|aldesleukin|
12068000|NCT00004248|Drug|doxorubicin hydrochloride|
12068001|NCT00004097|Drug|fluorouracil|
12068002|NCT00004097|Drug|gemcitabine hydrochloride|
12068003|NCT00004097|Drug|paclitaxel|
12068004|NCT00004097|Radiation|radiation therapy|
12068005|NCT00003967|Drug|etoposide|
12068006|NCT00003967|Drug|topotecan hydrochloride|
12068007|NCT00003883|Drug|fluconazole|
12068008|NCT00003883|Drug|itraconazole|
12068009|NCT00003769|Drug|perillyl alcohol|
12068010|NCT00003769|Procedure|surgical procedure|
12068011|NCT00003657|Biological|filgrastim|
12068012|NCT00003657|Drug|Amifostine|
12068013|NCT00003657|Drug|Carboplatin|
12068014|NCT00003657|Drug|Etoposide|
12068015|NCT00003657|Drug|Ifosfamide|
12068016|NCT00003657|Procedure|peripheral blood stem cell transplantation|
12068017|NCT00003635|Drug|nelarabine|
12068018|NCT00003412|Biological|recombinant interleukin-12|
12068019|NCT00003402|Drug|carmustine|
12068020|NCT00003402|Drug|cisplatin|
12068021|NCT00003402|Drug|cyclophosphamide|
12068022|NCT00003402|Drug|dexamethasone|
12068023|NCT00003402|Drug|etoposide|
12068024|NCT00003402|Drug|melphalan|
12068025|NCT00003402|Drug|paclitaxel|
12068026|NCT00003402|Procedure|bone marrow ablation with stem cell support|
12068027|NCT00003402|Procedure|peripheral blood stem cell transplantation|
12068028|NCT00080392|Drug|DNA Plasmid Vector|
12068029|NCT00080392|Drug|EW-A-401 DNA Plasmid Vector|
12068030|NCT00080340|Drug|TLK286 (Telcyta) HCl for Injection|
12068031|NCT00080340|Drug|gefitinib (Iressa)|
12068032|NCT00080327|Drug|Aripiprazole|Tablets, Oral, 2mg, Once daily, 6 weeks.
12068033|NCT00080327|Drug|Aripiprazole|Tablets, Oral, 5mg, Once daily, 6 weeks.
12068034|NCT00080327|Drug|Aripiprazole|Tablets, Oral, 10mg, Once daily, 6 weeks.
12068035|NCT00080327|Drug|Placebo|Tablets, Oral, 0mg, Once daily, 6 weeks.
12068036|NCT00080314|Drug|Aripiprazole|Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
12068037|NCT00080314|Drug|Placebo|Tablets, Oral, 0 mg, Once daily, 8 weeks.
12068038|NCT00080301|Drug|Ixabepilone + Capecitabine|"Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity
~Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity"
12068039|NCT00080301|Drug|Capecitabine|Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
12068040|NCT00003345|Drug|cisplatin|
12068041|NCT00003345|Drug|irinotecan hydrochloride|
12068042|NCT00003192|Drug|aminocamptothecin|
12068043|NCT00003157|Drug|cisplatin|
12068044|NCT00003157|Drug|gemcitabine hydrochloride|
12068045|NCT00003157|Radiation|radiation therapy|
12068046|NCT00003149|Biological|recombinant interleukin-12|
12068047|NCT00002974|Drug|carboplatin|
12068048|NCT00002974|Drug|etoposide|
12068049|NCT00002974|Drug|ifosfamide|
12068050|NCT00002974|Procedure|hyperthermia treatment|
12068051|NCT00080366|Drug|1-Octanol|
12068052|NCT00080353|Drug|IL-2|
12068053|NCT00080353|Drug|gp100:209-217|
12068054|NCT00080353|Drug|OKT3|
12068055|NCT00080353|Drug|rF-go 100P209|
12068056|NCT00080353|Drug|Montanide ISA 51|
12068057|NCT00080288|Drug|Armodafinil 150 mg/day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.
12068058|NCT00080288|Drug|Placebo|Matching placebo tablets once daily
12068059|NCT00080275|Drug|Niacin Extended-Release and simvastatin Tablets|
12068060|NCT00080262|Drug|Ixabepilone|Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
12068061|NCT00080236|Drug|IDN-6556|
12068062|NCT00080236|Drug|Placebo|
12068063|NCT00080223|Drug|Pirfenidone|up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study
12068064|NCT00080158|Drug|fluoxetine|
12068065|NCT00080158|Drug|sertraline|
12068066|NCT00080158|Drug|citalopram|
12068067|NCT00080158|Drug|escitalopram|
12068068|NCT00080158|Drug|bupropion|
12068069|NCT00080158|Drug|mirtazapine|
12068070|NCT00080158|Drug|venlafaxine|
12068071|NCT00080158|Drug|lithium|
12068072|NCT00080158|Behavioral|Cognitive Behavioral Therapy|
12068073|NCT00012142|Drug|temsirolimus|
12068074|NCT00002950|Biological|sargramostim|
12068075|NCT00002950|Drug|topotecan hydrochloride|
12068076|NCT00002947|Radiation|indium In 111 pentetreotide|
12068077|NCT00002887|Drug|cisplatin|
12068078|NCT00002887|Drug|etoposide|
12068079|NCT00002887|Drug|hydroxyurea|
12068080|NCT00002887|Drug|vinblastine sulfate|
12068081|NCT00002887|Drug|vindesine|
12068082|NCT00002887|Drug|vinorelbine tartrate|
12068083|NCT00002887|Procedure|drug resistance inhibition treatment|
12068084|NCT00002759|Drug|cyclosporine|
12068085|NCT00002759|Drug|irinotecan hydrochloride|
12068086|NCT00002759|Drug|phenobarbital|
12068087|NCT00002592|Biological|c-myb antisense oligonucleotide G4460|
12068088|NCT00002592|Biological|filgrastim|
12068089|NCT00002592|Drug|busulfan|
12068090|NCT00002592|Drug|cyclophosphamide|
12068091|NCT00002592|Procedure|autologous bone marrow transplantation|
12068092|NCT00002592|Procedure|in vitro-treated bone marrow transplantation|
12068093|NCT00002540|Other|Laboratory Biomarker Analysis|Correlative studies
12068094|NCT00002540|Procedure|Medical Examination|Undergo DRE
12068095|NCT00002540|Other|Screening Questionnaire Administration|Undergo questionnaire assessments
12068096|NCT00002536|Drug|cisplatin|
12068097|NCT00002536|Drug|vincristine sulfate|
12068098|NCT00002536|Procedure|surgical procedure|
12068099|NCT00002536|Radiation|radiation therapy|
12068100|NCT00002461|Biological|filgrastim|
12068101|NCT00002461|Biological|sargramostim|
12068102|NCT00002461|Drug|carmustine|
12068103|NCT00002461|Drug|cisplatin|
12068104|NCT00002461|Drug|cyclophosphamide|
12068105|NCT00002461|Drug|etoposide|
12068106|NCT00002461|Procedure|autologous bone marrow transplantation|
12068107|NCT00002461|Procedure|in vitro-treated bone marrow transplantation|
12068108|NCT00002461|Procedure|peripheral blood stem cell transplantation|
12068109|NCT00002461|Radiation|radiation therapy|
12068110|NCT00080210|Drug|Puricase|
12068111|NCT00080197|Drug|E7070|
12068112|NCT00080184|Procedure|Low Energy Neurofeedback System|
12068113|NCT00080145|Drug|Risperidone|
12068114|NCT00080145|Behavioral|Behavior Therapy|
12068115|NCT00080132|Drug|implitapide|
12068116|NCT00080119|Drug|Isoniazid (INH)|Antibiotic for the prevention and treatment of TB
12068117|NCT00080119|Drug|Trimethoprim/Sulfamethoxazole (TMP/SMX)|Antibiotic for the prevention and treatment of pneumocystis pneumonia (PCP)
12068118|NCT00080119|Drug|Isoniazid Placebo (PL)|Isoniazid placebo and TMP/SMX
12068119|NCT00080106|Biological|MRK Ad5 HIV-1 gag vaccine|MRK Ad5 HIV-1 gag vaccine injected into the upper arm muscle.
12068120|NCT00080106|Other|Vaccine placebo|MRK Ad5 HIV-1 gag placebo vaccine injected into the upper arm muscle.
12068121|NCT00010647|Procedure|Acupuncture|
12068122|NCT00008320|Drug|ceramide|
12068123|NCT00008151|Drug|cyclosporine|
12068124|NCT00008151|Drug|fludarabine phosphate|
12068125|NCT00008151|Drug|gemtuzumab ozogamicin|
12068126|NCT00008151|Drug|methotrexate|
12068127|NCT00008151|Drug|mycophenolate mofetil|
12068128|NCT00008151|Procedure|allogeneic bone marrow transplantation|
12068129|NCT00008151|Procedure|peripheral blood stem cell transplantation|
12068130|NCT00008151|Radiation|radiation therapy|
12068131|NCT00006348|Drug|ondansetron|
12068132|NCT00006348|Other|placebo|
12068133|NCT00006345|Biological|denileukin diftitox|
12068134|NCT00006345|Drug|dexamethasone|
12068135|NCT00006262|Drug|becatecarin|
12068136|NCT00006090|Drug|arsenic trioxide|
12068137|NCT00006084|Biological|lintuzumab|
12068138|NCT00006051|Drug|cisplatin|
12068139|NCT00006051|Drug|fluorouracil|
12068140|NCT00006051|Radiation|radiation therapy|
12068141|NCT00006036|Drug|cisplatin|
12068142|NCT00006036|Drug|lurtotecan liposome|
12068143|NCT00006030|Drug|tamoxifen citrate|
12068144|NCT00006030|Procedure|conventional surgery|
12068145|NCT00006030|Radiation|radiation therapy|
12068313|NCT00079677|Drug|Placebo|Matching placebo tablets once daily
12068146|NCT00080093|Behavioral|Individual feedback and specially-tailored manuals|Individual feedback and specially-tailored manuals
12068147|NCT00080093|Behavioral|General HIV information feedback and the best-available information|General HIV information feedback and the best-available information
12068148|NCT00080080|Drug|talabostat (PT-100) tablets|
12068149|NCT00080080|Drug|Docetaxel|
12068150|NCT00006023|Drug|capecitabine|
12068151|NCT00005992|Biological|PSA prostate cancer vaccine|
12068152|NCT00005992|Biological|therapeutic autologous dendritic cells|
12068153|NCT00005972|Drug|gemcitabine hydrochloride|
12068154|NCT00005972|Drug|irinotecan hydrochloride|
12068155|NCT00005944|Drug|chemotherapy|
12068156|NCT00005944|Drug|fluorouracil|
12068157|NCT00005944|Drug|leucovorin calcium|
12068158|NCT00005944|Drug|mitomycin C|
12068159|NCT00005944|Procedure|conventional surgery|
12068160|NCT00005944|Procedure|laparoscopic surgery|
12068161|NCT00005865|Drug|vinorelbine tartrate|
12068162|NCT00080054|Drug|Motexafin Gadolinium Injection|
12068163|NCT00080041|Drug|Motexafin Gadolinium Injection|
12068164|NCT00080028|Drug|Motexafin Gadolinium Injection|
12068165|NCT00080015|Drug|Diflomotecan (BN80915)|
12068166|NCT00080002|Drug|Pegamotecan|
12068167|NCT00079989|Drug|tigecycline|
12068168|NCT00005816|Biological|therapeutic autologous dendritic cells|
12068169|NCT00005816|Procedure|conventional surgery|
12068170|NCT00004123|Drug|Doxorubicin hydrochloride (DOX)|Doxorubicin IV bolus followed immediately by IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks.
12068171|NCT00004123|Procedure|Conventional surgery|Surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after chemoradiotherapy
12068172|NCT00004123|Radiation|Intraoperative radiation therapy (IORT)|Intraoperative radiotherapy (IORT) to tumor bed if all gross disease has been resected and if area of maximal tumor adherence to retroperitoneum can be encompassed within a single IORT field (maximum 15 cm).
12068173|NCT00004123|Radiation|Radiation Therapy (RT)|5 days a week for 4 weeks
12068174|NCT00003817|Drug|dolasetron mesylate|
12068175|NCT00003817|Drug|granisetron hydrochloride|
12068176|NCT00003817|Drug|ondansetron|
12068177|NCT00003817|Drug|tropisetron|
12068178|NCT00003817|Procedure|quality-of-life assessment|
12068179|NCT00003693|Drug|Dolastatin 10|IV bolus once every 3 weeks.
12068180|NCT00003647|Drug|allovectin-7|
12068181|NCT00003647|Drug|allovectin-7/dacarbazine|
12068182|NCT00003647|Drug|dacarbazine|
12068183|NCT00079976|Drug|Tigecycline|
12068184|NCT00079963|Dietary Supplement|Vitamin C|1000 mg/day
12068185|NCT00079963|Dietary Supplement|Vitamin E|800 IU/day
12068186|NCT00079963|Dietary Supplement|Placebo|
12068187|NCT00079950|Drug|Pegamotecan|
12068188|NCT00079937|Drug|Omalizumab|The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.
12068189|NCT00079937|Drug|Placebo|Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.
12068190|NCT00079937|Drug|Fluticasone|Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.
12068191|NCT00003561|Biological|recombinant interferon alfa|
12068192|NCT00003561|Biological|sargramostim|
12068193|NCT00003356|Biological|aldesleukin|
12068194|NCT00003356|Biological|rituximab|
12068195|NCT00003327|Drug|paclitaxel|
12068196|NCT00003321|Procedure|psychosocial assessment and care|
12068197|NCT00003321|Procedure|quality-of-life assessment|
12068198|NCT00003274|Biological|gp100 antigen|
12068199|NCT00003274|Biological|incomplete Freund's adjuvant|
12068200|NCT00003274|Biological|sargramostim|
12068201|NCT00003274|Biological|tyrosinase peptide|
12068202|NCT00079924|Drug|teriparatide|
12068203|NCT00079924|Drug|aldrenodate|
12068204|NCT00079924|Drug|raloxifene|
12068205|NCT00079911|Drug|valacyclovir hydrochloride|valacyclovir hydrochloride
12068206|NCT00079898|Procedure|Acupuncture|
12068207|NCT00079885|Drug|tigecycline|
12068208|NCT00079872|Drug|Pemetrexed|
12068209|NCT00022360|Drug|taurolidine|
12068210|NCT00022165|Dietary Supplement|selenium|
12068211|NCT00021138|Behavioral|smoking cessation intervention|
12068212|NCT00021138|Drug|nicotine|
12068213|NCT00003166|Drug|bryostatin 1|Given IV
12068214|NCT00003166|Drug|vincristine sulfate|Given IV
12068215|NCT00003166|Other|laboratory biomarker analysis|Correlative studies
12068216|NCT00002789|Drug|busulfan|
12068217|NCT00002789|Drug|cyclophosphamide|
12068218|NCT00002789|Drug|cyclosporine|
12068219|NCT00002789|Drug|methotrexate|
12068220|NCT00002789|Procedure|allogeneic bone marrow transplantation|
12068221|NCT00002789|Procedure|peripheral blood stem cell transplantation|
12068222|NCT00079859|Drug|Implitapide|
12068223|NCT00079846|Drug|Implitapide|
12068224|NCT00079833|Drug|Esomeprazole magnesium (Nexium)|
12068225|NCT00079820|Biological|ACAM3000 MVA Vaccine|Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
12068226|NCT00020930|Biological|cetuximab|
12068227|NCT00020865|Drug|cefepime hydrochloride|
12068228|NCT00020865|Drug|levofloxacin|
12068229|NCT00014300|Drug|glufosfamide|
12068230|NCT00012337|Drug|gefitinib|
12068231|NCT00009737|Drug|5-Fluorouracil|425mg/m2 iv daily from day 1 to day 5 every 28 days.
12068232|NCT00009737|Drug|Leucovorin|20mg/m2 iv daily from day 1 to day 5 every 28 days.
12068314|NCT00079664|Behavioral|Tai Chi|
12068233|NCT00009737|Drug|Capecitabine [Xeloda]|1250mg/m2 po bid on days 1-14 every 21 days.
12068234|NCT00006812|Drug|capecitabine|
12068235|NCT00006708|Biological|filgrastim|5 μg/kg/day subcutaneous injection on Days 5-12 every 21 days for 3 cycles.
12068236|NCT00006708|Biological|rituximab|
12068237|NCT00006708|Drug|carboplatin|
12068238|NCT00006708|Drug|etoposide|
12068239|NCT00006708|Drug|ifosfamide|
12068240|NCT00006218|Drug|triapine|
12068241|NCT00006215|Biological|filgrastim|
12068242|NCT00006215|Drug|docetaxel|
12068243|NCT00006215|Drug|vinorelbine tartrate|
12068244|NCT00006098|Drug|bortezomib|
12068245|NCT00079807|Drug|Alpha-Lipoic Acid|
12068246|NCT00079794|Drug|Iscar|
12068247|NCT00079794|Drug|mistletoe|
12068248|NCT00079781|Procedure|RNS® System implantation|Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.
12068249|NCT00079781|Device|RNS® System responsive stimulation|The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
12068250|NCT00079755|Drug|SGN-30 (anti-CD30 mAb)|
12068251|NCT00079742|Drug|Nutropin AQ [somatropin (DNA origin) injection]|
12068252|NCT00079716|Drug|SGN-40 (anti-huCD40 mAb)|0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
12068253|NCT00006091|Drug|arsenic trioxide|
12068254|NCT00006085|Drug|CP-609,754|
12068255|NCT00006026|Drug|rubitecan|
12068256|NCT00005866|Drug|busulfan|arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
12068257|NCT00005866|Drug|cyclophosphamide|arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
12068258|NCT00005866|Drug|cyclosporine|both arms per published schedule
12068259|NCT00005866|Drug|methotrexate|GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV
12068260|NCT00005866|Procedure|allogeneic bone marrow transplantation|day 0
12068261|NCT00005866|Radiation|radiation therapy|both arms: 1200 cGy total dose (6 x 200 fractions)
12068262|NCT00005848|Drug|chemotherapy|
12068263|NCT00005848|Drug|tipifarnib|
12068264|NCT00005834|Biological|filgrastim|Arms 1 and 2: 300 mcg (pts </= 60 kg) or 480 mcg (pts > 60 kg), SC beginning day 5
12068265|NCT00005834|Drug|cisplatin|Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4
12068266|NCT00005834|Drug|cyclophosphamide|Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4
12068267|NCT00005834|Drug|dexamethasone|Arms 1 and 2: 40 mg/d PO days 1-4
12068268|NCT00005834|Drug|etoposide|Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4
12068269|NCT00005834|Drug|thalidomide|Arm 2: 800 mg/d (max dose) PO daily
12068270|NCT00005635|Biological|trastuzumab|
12068271|NCT00005635|Drug|paclitaxel|
12068272|NCT00005085|Drug|becatecarin|
12068273|NCT00005037|Drug|temozolomide|
12068274|NCT00005037|Drug|Temozolomide|Temozolomide capsule once a day for 42 days every 10 weeks.
12068275|NCT00004926|Dietary Supplement|vitamin D3 analogue ILX23-7553|
12068276|NCT00004913|Drug|cisplatin|
12068277|NCT00004913|Drug|docetaxel|
12068278|NCT00004913|Drug|fluorouracil|
12068279|NCT00004913|Drug|leucovorin calcium|
12068280|NCT00004865|Biological|cetuximab|
12068281|NCT00004865|Drug|cisplatin|
12068282|NCT00004865|Drug|fluorouracil|
12068283|NCT00004865|Drug|paclitaxel|
12068284|NCT00004864|Drug|GEM 231|
12068285|NCT00004864|Drug|docetaxel|
12068286|NCT00004863|Drug|GEM 231|
12068287|NCT00004863|Drug|paclitaxel|
12068288|NCT00004163|Drug|Trastuzumab|
12068289|NCT00004151|Drug|acridine carboxamide|
12068290|NCT00004142|Drug|Floxuridine|Part of hepatic arterial chemotherapy on days 1-7. Treatment repeats every 5 weeks for 6 courses.
12068291|NCT00004142|Drug|Fluorouracil (5-FU)|Part of hepatic arterial chemotherapy over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses.
12068292|NCT00004142|Procedure|Conventional surgery|Open laparotomy to identify target tumor in liver using intraoperative ultrasound.
12068293|NCT00004142|Procedure|Radiofrequency ablation|Radiofrequency tissue ablation over 20 minutes to each tumor.
12068294|NCT00004109|Drug|Doxorubicin Hydrochloride|Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks
12068295|NCT00004109|Radiation|Radiation Therapy (RT)|External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).
12068296|NCT00003959|Biological|ras peptide cancer vaccine|
12068297|NCT00003959|Biological|sargramostim|
12068298|NCT00003779|Biological|Connaught|Compare two strains of BCG
12068299|NCT00003779|Biological|Tice|Compare two strains of BCG
12068300|NCT00003772|Procedure|quality-of-life assessment|
12068301|NCT00003742|Drug|cisplatin|
12068302|NCT00003742|Drug|irinotecan hydrochloride|
12068303|NCT00003742|Drug|paclitaxel|
12068304|NCT00003706|Drug|pemetrexed disodium|
12068305|NCT00003705|Drug|BMS-184476|
12068306|NCT00003704|Drug|capecitabine|
12068307|NCT00003704|Radiation|radiation therapy|
12068308|NCT00003703|Drug|SarCNU|
12068309|NCT00003695|Drug|chemotherapy|
12068310|NCT00003695|Procedure|surgical procedure|
12068311|NCT00079768|Drug|Alemtuzumab (Campath)|
12068312|NCT00079677|Drug|Armodafinil 150 mg/day|Armodafinil 150 mg once daily in the morning
12068315|NCT00079651|Behavioral|Montessori-based dementia programming|
12068316|NCT00079638|Drug|Niacin|
12068317|NCT00079638|Drug|Atorvastatin|
12068318|NCT00079638|Drug|Simvastatin|
12068319|NCT00079638|Drug|Ezetimibe|
12068320|NCT00079638|Drug|Rosuvastatin|
12068321|NCT00078039|Drug|Paliperidone ER|
12068322|NCT00003617|Drug|chlorambucil|
12068323|NCT00003617|Drug|clarithromycin|
12068324|NCT00003617|Drug|omeprazole|
12068325|NCT00003617|Drug|tinidazole|
12068326|NCT00003465|Drug|temozolomide|
12068327|NCT00003421|Biological|bleomycin sulfate|
12068328|NCT00003421|Drug|ABVD regimen|
12068329|NCT00003421|Drug|chlorambucil|
12068330|NCT00003421|Drug|dacarbazine|
12068331|NCT00003421|Drug|doxorubicin hydrochloride|
12068332|NCT00003421|Drug|etoposide|
12068333|NCT00003421|Drug|prednisolone|
12068334|NCT00003421|Drug|procarbazine hydrochloride|
12068335|NCT00003421|Drug|vinblastine sulfate|
12068336|NCT00003421|Drug|vincristine sulfate|
12068337|NCT00003421|Radiation|radiation therapy|
12068338|NCT00003368|Drug|irinotecan hydrochloride|
12068339|NCT00003361|Drug|decitabine|
12068340|NCT00003338|Procedure|immunoscintigraphy|
12068341|NCT00003338|Radiation|technetium Tc 99m epratuzumab|
12068342|NCT00003337|Procedure|immunoscintigraphy|
12068343|NCT00003337|Radiation|technetium Tc 99m epratuzumab|
12068344|NCT00003212|Drug|doxorubicin hydrochloride|
12068345|NCT00003212|Drug|ifosfamide|
12068346|NCT00003021|Drug|bizelesin|
12068347|NCT00003014|Drug|carboplatin|
12068348|NCT00003014|Radiation|radiation therapy|
12068349|NCT00002930|Procedure|positron emission tomography|
12068350|NCT00002930|Radiation|fludeoxyglucose F 18|
12068351|NCT00002928|Drug|paclitaxel|
12068352|NCT00002919|Biological|filgrastim|
12068353|NCT00002919|Drug|cisplatin|
12068354|NCT00002919|Drug|doxorubicin hydrochloride|
12068355|NCT00002919|Drug|methotrexate|
12068356|NCT00002919|Drug|vinblastine sulfate|
12068357|NCT00002919|Procedure|conventional surgery|
12068358|NCT00002901|Drug|docetaxel|
12068359|NCT00002858|Drug|cisplatin|
12068360|NCT00002858|Drug|cyclophosphamide|
12068361|NCT00002858|Drug|doxorubicin hydrochloride|
12068362|NCT00002858|Drug|etoposide|
12068363|NCT00002858|Radiation|radiation therapy|
12068364|NCT00079612|Drug|Sorafenib (Nexavar, BAY43-9006)|800mg daily (2x 400mg tabs)
12068365|NCT00079612|Drug|Placebo|2x 400mg tabs daily
12068366|NCT00079586|Drug|Heparin|Unfractionated Heparin per institutional practice
12068367|NCT00079586|Drug|Bivalirudin|1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion
12068368|NCT00079508|Drug|Angiomax (bivalirudin)|250 mg vial administered as 1.0 mg/kg intravenous (IV) bolus and 2.5 mg/kg/h IV infusion during the procedure with the option to administer additional 0.1 to 0.5 mg/kg boluses to increase the level of anticoagulation as clinically indicated. A low-dose infusion could have been administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. A starting bolus of 0.1 mg/kg and/or an infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended.
12068369|NCT00021359|Drug|dexamethasone|
12068370|NCT00021359|Drug|isotretinoin|
12068371|NCT00017030|Drug|trabectedin|
12068372|NCT00016978|Drug|FOLFOX regimen|
12068373|NCT00016978|Drug|fluorouracil|
12068374|NCT00016978|Drug|leucovorin calcium|
12068375|NCT00016978|Drug|oxaliplatin|
12068376|NCT00014547|Drug|BBR 3464|
12068377|NCT00007969|Biological|Detox-B adjuvant|
12068378|NCT00007969|Drug|verteporfin|
12068379|NCT00002823|Drug|cisplatin|
12068380|NCT00002823|Drug|etoposide|
12068381|NCT00002823|Drug|vinblastine sulfate|
12068382|NCT00002823|Drug|vindesine|
12068383|NCT00002823|Drug|vinorelbine tartrate|
12068384|NCT00002823|Radiation|radiation therapy|
12068385|NCT00002650|Dietary Supplement|folic acid|
12068386|NCT00002601|Biological|filgrastim|5 ug/kg daily following stem cell reinfusion
12068387|NCT00002601|Drug|cisplatin|Course 2 - 100 mg/m2 at an infusion rate of 25 mg/hr
12068388|NCT00002601|Drug|doxorubicin hydrochloride|Course 1 - 150 mg/m2 by continuous intravenous infusion for 96 hours.
12068389|NCT00002601|Drug|ifosfamide|Course 1 - 14 gm/M2 by continuous intravenous infusion for 96 hours.
12068390|NCT00002601|Drug|melphalan|Course 2 - 75 mg/m2 infused at a rate of 5 mg/minute
12068391|NCT00002601|Procedure|peripheral blood stem cell transplantation|Administered on Day 0 following high-dose chemotherapy in both courses 1 and 2
12068392|NCT00002581|Drug|cyclophosphamide|
12068393|NCT00002581|Drug|fluorouracil|
12068394|NCT00002581|Drug|methotrexate|
12068395|NCT00002581|Drug|tamoxifen citrate|
12068396|NCT00002581|Procedure|conventional surgery|
12068397|NCT00002581|Radiation|radiation therapy|
12068398|NCT00002580|Drug|cyclophosphamide|
12068399|NCT00002580|Drug|fluorouracil|
12068400|NCT00002580|Drug|goserelin acetate|
12068401|NCT00002580|Drug|leuprolide acetate|
12068402|NCT00002580|Drug|methotrexate|
12068403|NCT00002580|Drug|tamoxifen citrate|
12068404|NCT00002580|Procedure|conventional surgery|
12068405|NCT00002580|Procedure|laparoscopic surgery|
12068406|NCT00002580|Procedure|oophorectomy|
12068407|NCT00002580|Radiation|radiation therapy|
12068408|NCT00002537|Drug|topotecan hydrochloride|
12068409|NCT00002537|Radiation|radiation therapy|
12068410|NCT00002526|Biological|filgrastim|
12068411|NCT00002526|Drug|doxorubicin hydrochloride|
12068412|NCT00002526|Drug|ifosfamide|
12068413|NCT00002508|Drug|carboplatin|
12068415|NCT00002508|Procedure|autologous bone marrow transplantation|
12068416|NCT00002508|Procedure|peripheral blood stem cell transplantation|
12068417|NCT00002480|Radiation|radiation therapy|
12068418|NCT00002459|Radiation|radiation therapy|
12068419|NCT00079625|Drug|Th2/Tc2 Cells|
12068420|NCT00079599|Drug|L-carnitine|A study drug, L-carnitine, titrating the doses from 0.5 g to 3 g to reduce the possibility of side effects, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
12068421|NCT00079599|Other|Placebo|A placebo, where patients underwent the dose titration identical to the study patients, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
12068422|NCT00079573|Behavioral|Atkins diet (extremely low carbohydrate)|
12068423|NCT00079573|Behavioral|Zone diet (low carbohydrate, high protein)|
12068424|NCT00079573|Behavioral|Ornish diet (very low fat)|
12068425|NCT00079560|Drug|dronabinol|dronabinol to prevent development of marijuana withdrawal
12068426|NCT00079547|Behavioral|Low-calorie diet|low-calorie diet
12068427|NCT00079547|Behavioral|low-carbohydrate diet|low-carbohydrate diet
12068428|NCT00079534|Behavioral|Non-local/distant healing or prayer|
12068429|NCT00079521|Procedure|Therapeutic Touch|
12068430|NCT00079495|Drug|NBI-5788|
12068431|NCT00079482|Drug|CEP-701|
12068432|NCT00079482|Drug|high-dose cytarabine|Chemotherapy
12068433|NCT00079482|Drug|Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)|Chemotherapy
12068434|NCT00079469|Behavioral|smoking cessation intervention|
12068435|NCT00079469|Drug|bupropion hydrochloride|
12068436|NCT00079456|Drug|temsirolimus|Given IV
12068437|NCT00079456|Other|pharmacological study|Correlative studies
12068438|NCT00079456|Other|laboratory biomarker analysis|Correlative studies
12068439|NCT00079443|Drug|romidepsin|Given IV
12068440|NCT00079443|Biological|rituximab|Given IV
12068441|NCT00079443|Drug|fludarabine phosphate|Given IV
12068442|NCT00079443|Other|laboratory biomarker analysis|Correlative studies
12068443|NCT00079430|Procedure|adjuvant therapy|
12068444|NCT00079430|Drug|paclitaxel|Given IV
12068445|NCT00079430|Drug|carboplatin|Given intraperitoneally
12068446|NCT00079430|Biological|bevacizumab|Given IV
12068447|NCT00079417|Procedure|cryosurgery|Application of extreme cold to destroy abnormal or diseased tissue.
12068448|NCT00079417|Procedure|infrared laser therapy|"Laser therapy or photobiomodulation is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects"
12068449|NCT00079417|Radiation|iodine I 125|Undergo radioactive therapy
12068450|NCT00079417|Radiation|ruthenium Ru 106|Undergo radioactive therapy
12068451|NCT00079417|Drug|carboplatin|Given IV
12068452|NCT00079417|Drug|vincristine sulfate|Given IV
12068453|NCT00079417|Radiation|radiation therapy|Undergo radioactive therapy
12068454|NCT00079404|Drug|tanespimycin|Given IV
12068455|NCT00079391|Device|allogeneic hematopoietic stem cell transplantation|Manipulated Peripheral Blood Stem Cell graft on Day 0. Target CD34+ dose 6 x10e6/kg, (range 3 to 8x10e6/kg) CD3+ dose fixed to 2 x 10e4/kg.
12068456|NCT00079378|Drug|decitabine|Given IV
12068457|NCT00079378|Drug|valproic acid|Given orally
12068458|NCT00079378|Other|pharmacological study|Correlative studies
12068459|NCT00079378|Other|laboratory biomarker analysis|Correlative studies
12068460|NCT00079365|Drug|fluorouracil|
12068461|NCT00079365|Drug|gemcitabine hydrochloride|
12068462|NCT00079365|Radiation|brachytherapy|
12068463|NCT00079365|Radiation|phosphorus P32|
12068464|NCT00079365|Radiation|radiation therapy|
12068465|NCT00079352|Drug|alvocidib|Given IV
12068466|NCT00079352|Drug|gemcitabine hydrochloride|Given IV
12068467|NCT00079352|Drug|irinotecan hydrochloride|Given IV
12068468|NCT00079339|Radiation|radiation therapy|Undergo radiotherapy
12068469|NCT00079339|Drug|tipifarnib|Given orally
12068470|NCT00079326|Biological|trastuzumab|Given IV
12068471|NCT00079326|Drug|ixabepilone|Given IV
12068472|NCT00079326|Other|laboratory biomarker analysis|Correlative studies
12068473|NCT00079313|Drug|Imatinib|
12068474|NCT00079300|Drug|imiquimod|
12068475|NCT00079300|Procedure|conventional surgery|
12068476|NCT00079287|Drug|carboplatin|
12068477|NCT00079287|Drug|docetaxel|
12068478|NCT00079287|Drug|gemcitabine hydrochloride|
12068479|NCT00079287|Drug|paclitaxel|
12068480|NCT00079287|Drug|vinorelbine tartrate|
12068481|NCT00079274|Drug|irinotecan hydrochloride|Given IV
12068482|NCT00079274|Drug|oxaliplatin|Given IV
12068483|NCT00079274|Drug|leucovorin calcium|Given IV
12068484|NCT00079274|Drug|fluorouracil|Given IV
12068485|NCT00079274|Biological|cetuximab|Given IV
12068486|NCT00079274|Drug|Locally Directed Therapy|Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
12068487|NCT00079261|Drug|CHOP regimen|
12068488|NCT00079261|Drug|cyclophosphamide|
12068489|NCT00079261|Drug|doxorubicin hydrochloride|
12068490|NCT00079261|Drug|gemcitabine hydrochloride|
12068491|NCT00079261|Drug|prednisone|
12068492|NCT00079261|Drug|vincristine sulfate|
12068493|NCT00079248|Biological|therapeutic progesterone|
12068494|NCT00079248|Drug|conjugated estrogens|
12068495|NCT00079235|Drug|temsirolimus|Given IV
12068496|NCT00079235|Other|laboratory biomarker analysis|Correlative studies
12068497|NCT00079222|Drug|itraconazole|
12068498|NCT00079222|Drug|voriconazole|
12068499|NCT00079183|Drug|sirolimus|Given PO
12068500|NCT00079170|Dietary Supplement|garlic|
12068501|NCT00079170|Drug|docetaxel|
12068502|NCT00079157|Biological|incomplete Freund's adjuvant|
12068503|NCT00079157|Biological|sargramostim|
12068504|NCT00079157|Biological|telomerase: 540-548 peptide vaccine|
12068505|NCT00079144|Biological|NY-ESO-1 peptide vaccine|
12068506|NCT00079144|Biological|aldesleukin|
12068507|NCT00079144|Biological|filgrastim|
12068508|NCT00079144|Biological|incomplete Freund's adjuvant|
12068509|NCT00079144|Biological|therapeutic autologous lymphocytes|
12068510|NCT00079144|Drug|cyclophosphamide|
12068511|NCT00079144|Drug|fludarabine phosphate|
12068512|NCT00079131|Biological|oblimersen sodium|Given IV
12068513|NCT00079131|Other|pharmacological study|Correlative studies
12068514|NCT00079131|Other|laboratory biomarker analysis|Correlative studies
12068515|NCT00079118|Drug|docetaxel|
12068516|NCT00079118|Drug|irinotecan hydrochloride|
12068517|NCT00079105|Biological|bleomycin sulfate|Treatment
12068518|NCT00079105|Drug|cyclophosphamide|Treatment
12068519|NCT00079105|Drug|etoposide|Treatment
12068520|NCT00079105|Drug|mitoxantrone hydrochloride|Treatment
12068521|NCT00079105|Drug|prednisolone|Treatment
12068522|NCT00079105|Drug|procarbazine hydrochloride|Treatment
12068523|NCT00079105|Drug|vinblastine sulfate|Treatment
12068524|NCT00079092|Drug|procarbazine hydrochloride|
12068525|NCT00079092|Drug|thalidomide|
12068526|NCT00079079|Drug|carboplatin|
12068527|NCT00079079|Drug|cisplatin|
12068528|NCT00079079|Drug|gemcitabine hydrochloride|
12068529|NCT00079066|Biological|cetuximab|
12068530|NCT00079066|Procedure|quality-of-life assessment|
12068531|NCT00079053|Drug|erlotinib hydrochloride|
12068532|NCT00079053|Procedure|adjuvant therapy|
12068533|NCT00079040|Drug|cisplatin|Given IV
12068534|NCT00079040|Drug|etoposide|Given IV
12068535|NCT00079040|Biological|bevacizumab|Given IV
12068536|NCT00079040|Other|laboratory biomarker analysis|Correlative studies
12068537|NCT00079027|Drug|doxorubicin hydrochloride|
12068538|NCT00079027|Procedure|hepatic artery embolization|
12068539|NCT00079014|Drug|triapine|Given IV
12068540|NCT00079014|Drug|doxorubicin hydrochloride|Given IV
12068541|NCT00079014|Other|laboratory biomarker analysis|Correlative studies
12068542|NCT00079014|Other|pharmacological study|Correlative studies
12068543|NCT00079001|Drug|zoledronic acid|Given IV
12068544|NCT00079001|Other|placebo|Given IV
12068545|NCT00079001|Drug|androgen deprivation therapy|Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive androgen deprivation therapy per SWOG-9346. All other patients will receive androgen deprivation therapy at a standard dose and schedule throughout the study.
12068546|NCT00079001|Drug|GnRH agonist|Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive the GnRH agonist per SWOG-9346. All other patients will receive GnRH agonist at a standard dose and schedule throughout the study.
12068547|NCT00079001|Dietary Supplement|Calcium supplement|Patients will receive 500 mg by mouth daily of a calcium supplement or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.
12068548|NCT00079001|Dietary Supplement|Vitamin D|Patients will receive a multivitamin tablet containing 400-500 IU vitamin D by mouth daily or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.
12068549|NCT00078988|Biological|filgrastim|Given IV
12068550|NCT00078988|Drug|carboplatin|Given IV
12068551|NCT00078988|Drug|etoposide|Given IV
12068552|NCT00078988|Drug|isotretinoin|Given IV
12068553|NCT00078988|Drug|thiotepa|Given IV
12068554|NCT00078988|Procedure|autologous bone marrow transplantation|Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)
12068555|NCT00078988|Procedure|peripheral blood stem cell transplantation|Filgrastim is to be given daily in the afternoon for 4 days prior to the first harvest and continued until the completion of the daily harvests. The daily PBSC harvesting should be started prior to the fifth dose of filgrastim.
12068556|NCT00078975|Drug|gemcitabine hydrochloride|
12068557|NCT00078975|Drug|triapine|
12068558|NCT00078962|Biological|GTI-2040|Given IV
12068559|NCT00078962|Drug|gemcitabine hydrochloride|Given IV
12068560|NCT00078962|Other|laboratory biomarker analysis|Correlative studies
12068561|NCT00078962|Other|pharmacological study|Correlative studies
12068562|NCT00078949|Biological|rituximab|Given IV
12068563|NCT00078949|Drug|cisplatin|Given IV
12068564|NCT00078949|Drug|cytarabine|Given IV
12068565|NCT00078949|Drug|dexamethasone|Given IV
12068566|NCT00078949|Drug|gemcitabine hydrochloride|Given IV
12068567|NCT00078923|Dietary Supplement|soy isoflavones|
12068568|NCT00078923|Procedure|neoadjuvant therapy|Prostatectomy or Brachytherapy
12068569|NCT00078923|Other|Placebo|Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules
12068570|NCT00078910|Drug|exisulind|
12068571|NCT00078910|Procedure|conventional surgery|
12068572|NCT00078910|Procedure|neoadjuvant therapy|
12068573|NCT00078897|Drug|Selenium|Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
12068574|NCT00078858|Drug|fludarabine phosphate|Given IV
12068575|NCT00078858|Radiation|total-body irradiation|Undergo TBI
12068576|NCT00078858|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBMC transplantation
12068577|NCT00078858|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBMC transplantation
12068578|NCT00078858|Drug|cyclosporine|Given PO
12068579|NCT00078858|Drug|mycophenolate mofetil|Given PO or IV
12068580|NCT00078858|Other|laboratory biomarker analysis|Correlative studies
12068581|NCT00078845|Drug|Amifostine|500 mg three times a week.
12068582|NCT00078832|Drug|anastrozole|aromatase inhibitor
12068583|NCT00078832|Drug|placebo|Arimidex placebo
12068584|NCT00078819|Drug|Etanercept|Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week
12068585|NCT00078819|Drug|Placebo|Placebo matching to etanercept administered by subcutaneous injection once a week
12068586|NCT00078806|Drug|Etanercept|Administered by subcutaneous injection twice a week
12068587|NCT00078806|Drug|Placebo|Administered by subcutaneous injection twice a week
12068588|NCT00078793|Drug|Enbrel®|Etanercept alone, etanercept plus methotrexate or other DMARDs
12068589|NCT00078767|Behavioral|Trauma-Focused Cognitive Behavioral Therapy|12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
12068590|NCT00078767|Drug|Sertraline Pill|12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
12068591|NCT00078767|Drug|Placebo Oral Tablet|12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
12068592|NCT00078754|Drug|Fluoxetine|Fluoxetine capsules by mouth, up to 60 mg daily
12068593|NCT00078754|Drug|Divalproex|Divalproex ER capsules by mouth, up to 3000 mg daily
12068594|NCT00078754|Drug|Placebo|Placebo capsules by mouth, up to 8 capsules daily
12068595|NCT00078741|Behavioral|Cognitive Behavioral Therapy (CBT)|
12068596|NCT00078728|Behavioral|Family-Based Anxiety Prevention Program|Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.
12068597|NCT00078728|Behavioral|Evaluation only|Participants will undergo evaluations without active treatment for 8 weeks.
12068598|NCT00078611|Drug|natalizumab|
12068599|NCT00007007|Procedure|management of therapy complications|
12068600|NCT00007007|Procedure|quality-of-life assessment|
12068601|NCT00006890|Drug|prednisone|Prednisone 50mg on alternate days
12068602|NCT00006890|Drug|thalidomide|THALIDOMIDE 200 mg qhs
12068603|NCT00006467|Drug|ISIS 2503|
12068604|NCT00006467|Drug|gemcitabine hydrochloride|
12068605|NCT00006452|Drug|motexafin gadolinium|
12068606|NCT00006452|Radiation|radiation therapy|
12068607|NCT00006350|Biological|daclizumab|
12068608|NCT00006350|Biological|therapeutic allogeneic lymphocytes|
12068609|NCT00006350|Drug|mycophenolate mofetil|
12068610|NCT00006350|Drug|tacrolimus|
12068611|NCT00006350|Procedure|peripheral blood stem cell transplantation|
12068612|NCT00006259|Radiation|stereotactic radiosurgery|Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1.
12068613|NCT00006253|Behavioral|Nurse|Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
12068614|NCT00006253|Behavioral|Non-nurse coach|Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management
12068615|NCT00006126|Drug|busulfan|
12068616|NCT00006126|Drug|cyclophosphamide|
12068617|NCT00006126|Drug|etoposide|
12068618|NCT00006126|Drug|fludarabine phosphate|
12068619|NCT00006126|Procedure|peripheral blood stem cell transplantation|
12068620|NCT00006126|Radiation|radiation therapy|
12068621|NCT00006115|Drug|FOLFIRI regimen|
12068622|NCT00006115|Drug|FOLFOX regimen|
12068623|NCT00006115|Drug|fluorouracil|
12068624|NCT00006115|Drug|irinotecan hydrochloride|
12068625|NCT00006115|Drug|leucovorin calcium|
12068626|NCT00006115|Drug|oxaliplatin|
12068627|NCT00006018|Drug|BMS-214662|This is a dose-escalation study of BMS-214662. BMS-214662 IV over 1 hour on day 3 of course 1. For all subsequent courses, patients receive BMS-214662 IV over 1 hour on day 1 (30 minutes after paclitaxel). Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
12068628|NCT00006018|Drug|paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1 of course 1. For all subsequent courses, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
12068629|NCT00078715|Drug|Yohimbine hydrochloride|Participants receive yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep.
12068630|NCT00078715|Drug|Placebo|Participants receive an inactive equivalent of yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep.
12068631|NCT00078689|Drug|Daclizumab|
12068632|NCT00078637|Drug|E7820|
12068633|NCT00006000|Drug|cisplatin|
12068634|NCT00006000|Drug|irinotecan hydrochloride|
12068635|NCT00006000|Drug|semaxanib|
12068636|NCT00005965|Drug|bryostatin 1|
12068637|NCT00005965|Drug|cisplatin|
12068638|NCT00005947|Biological|sipuleucel-T|Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
12068639|NCT00005947|Biological|Placebo|Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
12068640|NCT00005946|Biological|filgrastim|
12068641|NCT00005946|Biological|therapeutic allogeneic lymphocytes|
12068642|NCT00005946|Drug|cyclophosphamide|
12068643|NCT00005946|Drug|etoposide|
12068644|NCT00005843|Drug|tipifarnib|
12068645|NCT00078663|Behavioral|Oral Care|
12068646|NCT00078624|Other|Traditional exercise therapy for knee osteoarthritis|Exercises include stretching, strengthening, and aerobic exercise
12068647|NCT00078624|Other|Knee stability training|The addition of agility and perturbation training techniques to the traditional exercise program
12068648|NCT00005595|Drug|arsenic trioxide|
12068649|NCT00005096|Drug|docetaxel|
12068650|NCT00005035|Drug|oxaliplatin|
12068651|NCT00004914|Biological|epoetin alfa|
12068652|NCT00004914|Procedure|physical therapy|
12068653|NCT00078598|Drug|Rituximab or Iodine I 131 Tositumomab Therapy|
12068654|NCT00078585|Biological|PROSTVAC®-VF/TRICOM™|
12068655|NCT00078572|Drug|capecitabine|Capecitabine daily dose divided and given twice daily orally, for 14 days, every 21 days. The capecitabine starting dose for the monotherapy arm was 2500 mg/m2 and for the combination arm was 2000 mg/m2.
12068656|NCT00078572|Drug|lapatinib (GW572016)|Lapatinib 1250 mg orally once daily
12068657|NCT00078507|Behavioral|Sensory Re-training|
12068658|NCT00078507|Behavioral|Sensory Retraining|Facial Exercises
12068659|NCT00078507|Behavioral|Opening Exercises|
12068660|NCT00004912|Drug|megestrol acetate|
12068661|NCT00004912|Procedure|physical therapy|
12068662|NCT00004908|Drug|cyclophosphamide|
12068663|NCT00004908|Procedure|peripheral blood stem cell transplantation|
12068664|NCT00004908|Radiation|radiation therapy|
12068665|NCT00004904|Biological|anti-thymocyte globulin|
12068666|NCT00004904|Biological|filgrastim|
12068667|NCT00004904|Drug|cladribine|
12068668|NCT00004904|Drug|cyclophosphamide|
12068669|NCT00004904|Drug|etoposide|
12068670|NCT00004904|Drug|methylprednisolone|
12068671|NCT00004904|Drug|tacrolimus|
12068672|NCT00004904|Procedure|allogeneic bone marrow transplantation|
12068673|NCT00004904|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12068674|NCT00004898|Biological|filgrastim|
12068675|NCT00004898|Drug|cyclophosphamide|
12068676|NCT00004898|Drug|etoposide|
12068677|NCT00004898|Procedure|peripheral blood stem cell transplantation|
12068678|NCT00004898|Radiation|radiation therapy|
12068679|NCT00004235|Drug|docetaxel|
12068680|NCT00004235|Drug|irinotecan hydrochloride|
12068681|NCT00004175|Drug|cyclophosphamide|
12068682|NCT00004175|Drug|docetaxel|
12068683|NCT00004175|Drug|doxorubicin hydrochloride|
12068684|NCT00004175|Procedure|conventional surgery|
12068685|NCT00078559|Drug|Alemtuzumab|30mg intravenous infusion on days 0 (transplant), 1, and 2
12068686|NCT00078559|Drug|Sirolimus|2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year
12068687|NCT00078559|Drug|Tacrolimus|2mg orally twice daily, on days 1-60
12068688|NCT00078559|Procedure|Kidney transplant|Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)
12068689|NCT00078559|Drug|Methylprednisolone (or equivalent)|250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab
12068690|NCT00078559|Drug|Acetaminophen|650 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
12068691|NCT00078559|Drug|Diphenhydramine|25 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
12068692|NCT00078559|Drug|Trimethoprim (TMP)/Sulfa (Bactrim, Septra)|1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.
12068693|NCT00078559|Drug|Valgancyclovir|Given orally beginning on day 1 for up to 10 days post-transplant (until participant discharged from hospital if prior to 10 days). Dose adjusted based on participants calculated creatinine clearance
12068694|NCT00078559|Drug|Acyclovir|400 mg orally twice daily or 800 mg orally four times daily (dose adjusted based on calculated creatinine clearance and cytomegalovirus antibody serologic status of donor and recipient) for a minimum of 3 months starting when valganciclovir discontinued.
12068695|NCT00078559|Drug|Pentamidine|300 mg/6 mL inhalation therapy once monthly for a total of 6 treatments. First treatment given within one week post-transplant for participants with a known allergy or intolerance to sulfa
12068696|NCT00078559|Drug|Clotrimazole|10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)
12068697|NCT00078559|Drug|Nystatin|500,000 units/5 mL orally four times daily for a minimum of 3 months post-transplant (subjects take either nystatin or clotrimazole, not both)
12068698|NCT00078546|Biological|EBV specific CTL Infusion|"One injection at one of the following dose levels
~Dose level I: 2x107/m2 Dose level II: 5x107/m2 Dose level III: 1x108/m2"
12068699|NCT00078546|Biological|Anti CD45 monoclonal antibody|400ug/kg over 6 to 8 hr for 4 days
12068700|NCT00078533|Biological|CMV CTL infusion|Three dose levels will be explored. The lowest dose level will be 1x10^7cells/m2 and the highest will be 1x10^8/m2. 3-6 pts will be entered at each dose level (depending on toxicity). If there are no toxicities and immunological efficacy is not seen at any dose, then the doses will be further escalated after additional local and federal approval. Additional patients will be treated at dose level 1 in order to assess the secondary objective of virus-specific immunity from the CTL infusions
12068701|NCT00078520|Biological|Dose Level 1|IL-2-B-CLL 2 x 10^7; CD40L-B-CLL 0
12068702|NCT00078520|Biological|Dose Level 2|IL-2-B-CLL 2 x 10^7; CD40L-B-CLL 2 x 10^6
12068703|NCT00078520|Biological|Dose Level 2- Fixed Dose|IL-2-B-CLL 2 x 10^7; CD40L-B-CLL 2 x 10^7
12068704|NCT00078468|Drug|PELITREXOL/AG-2037|
12068705|NCT00078494|Drug|EBV-LMP-2|
12068706|NCT00078481|Drug|Idebenone|
12068707|NCT00078455|Drug|ILX651|
12068708|NCT00078221|Device|Rheopheresis blood filtration|
12068709|NCT00004171|Drug|busulfan|
12068710|NCT00004171|Drug|cyclophosphamide|
12068711|NCT00004171|Procedure|peripheral blood stem cell transplantation|
12068712|NCT00004091|Other|Papanicolaou test|
12068713|NCT00004091|Other|cytology specimen collection procedure|
12068714|NCT00004091|Other|fluorescent antibody technique|
12068715|NCT00004091|Procedure|colposcopic biopsy|
12068716|NCT00004091|Procedure|study of high risk factors|
12068717|NCT00003528|Drug|raltitrexed|Given IV
12068718|NCT00003351|Drug|irinotecan hydrochloride|
12068719|NCT00003302|Procedure|biopsy|
12068720|NCT00003302|Diagnostic Test|magnetic resonance imaging|
12068721|NCT00003302|Diagnostic Test|mammography|
12068722|NCT00003264|Drug|cisplatin|
12068723|NCT00003264|Drug|gemcitabine hydrochloride|
12068724|NCT00003070|Drug|enalapril maleate|
12068725|NCT00003070|Procedure|quality-of-life assessment|
12068810|NCT00006037|Drug|irinotecan hydrochloride|
12068726|NCT00003040|Procedure|laser surgery|CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed
12068727|NCT00003040|Radiation|radiation therapy|200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery
12068728|NCT00002825|Biological|filgrastim|
12068729|NCT00002825|Drug|docetaxel|
12068730|NCT00002652|Drug|suramin|
12068731|NCT00026429|Biological|denileukin diftitox|
12068732|NCT00025012|Drug|isotretinoin|
12068733|NCT00024037|Procedure|management of therapy complications|
12068734|NCT00022542|Drug|ixabepilone|Given IV
12068735|NCT00022308|Drug|cisplatin|
12068736|NCT00022308|Drug|irinotecan hydrochloride|
12068737|NCT00022308|Radiation|radiation therapy|
12068738|NCT00022217|Drug|carboplatin|
12068739|NCT00022217|Drug|cisplatin-e therapeutic implant|
12068740|NCT00022217|Drug|paclitaxel|
12068741|NCT00022178|Drug|cisplatin|
12068742|NCT00022178|Drug|cyclophosphamide|
12068743|NCT00022178|Drug|doxorubicin hydrochloride|
12068744|NCT00022178|Drug|epirubicin hydrochloride|
12068745|NCT00022178|Drug|fluorouracil|
12068746|NCT00022178|Drug|vincristine sulfate|
12068747|NCT00021996|Drug|valdecoxib|
12068748|NCT00021372|Drug|estramustine phosphate sodium|
12068749|NCT00021372|Drug|paclitaxel|
12068750|NCT00020618|Drug|morphine sulfate|
12068751|NCT00020618|Procedure|quality-of-life assessment|
12068752|NCT00020098|Procedure|evaluation of cancer risk factors|
12068753|NCT00019409|Drug|asparaginase|
12068754|NCT00019409|Drug|cyclophosphamide|
12068755|NCT00019409|Drug|cytarabine|
12068756|NCT00019409|Drug|daunorubicin hydrochloride|
12068757|NCT00019409|Drug|mercaptopurine|
12068758|NCT00019409|Drug|methotrexate|
12068759|NCT00019409|Drug|prednisone|
12068760|NCT00019409|Drug|therapeutic hydrocortisone|
12068761|NCT00019409|Drug|vincristine sulfate|
12068762|NCT00019409|Radiation|radiation therapy|
12068763|NCT00017303|Drug|carboplatin|
12068764|NCT00017303|Drug|oglufanide disodium|
12068765|NCT00017303|Drug|paclitaxel|
12068766|NCT00017303|Procedure|conventional surgery|
12068767|NCT00016367|Biological|Trastuzumab|"Regimen A: Trastuzumab IV over 90 minutes on days 2 and 8.
~Regimen B: Trastuzumab IV over 30-90 minutes on days 1, 8 and 15."
12068768|NCT00016367|Drug|Cisplatin|"Regimen A: Cisplatin IV over 2 hours on day 1 following gemcitabine.
~Regimen B: Cisplatin IV over 2 hours on day 1."
12068769|NCT00016367|Drug|Gemcitabine Hydrochloride|"Regimen A: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab.
~Regimen B: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab."
12068770|NCT00015990|Drug|thalidomide|Given orally
12068771|NCT00015990|Other|laboratory biomarker analysis|Correlative studies
12068772|NCT00015964|Drug|ZD1839|
12068773|NCT00002597|Drug|flutamide|Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.
12068774|NCT00002597|Drug|Zoladex|3.6 mg s.c. monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
12068775|NCT00002597|Drug|Lupron|7.5 mg IM (intramuscular) monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
12068776|NCT00002597|Radiation|radiation therapy|46.8 Gy (1.8 Gy/day four to five times a week [26 fx]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.
12068777|NCT00002577|Radiation|radiation therapy|
12068778|NCT00002454|Biological|autologous tumor cell vaccine|
12068779|NCT00078442|Drug|Pegylated interferon alfa-2a|Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment
12068780|NCT00078390|Drug|S-3304|S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
12068781|NCT00078390|Other|Chemo-irradiation|Standard of care chemo-irradiation
12068782|NCT00078377|Drug|Armodafinil|Armodafinil 250 mg once daily in the morning
12068783|NCT00078377|Drug|Armodafinil|Armodafinil 150 mg once daily in the morning
12068784|NCT00078377|Drug|Placebo|Matching placebo tablets once daily
12068785|NCT00078338|Drug|Rebif®|Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
12068786|NCT00078338|Drug|Copaxone®|Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
12068787|NCT00076687|Biological|botulinum toxin Type A|botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
12068788|NCT00076687|Biological|botulinum toxin Type A|botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
12068789|NCT00076687|Drug|saline|Saline injection at Day 1, Week 12, Week 18
12068790|NCT00014690|Drug|plevitrexed|
12068791|NCT00014690|Drug|topotecan hydrochloride|
12068792|NCT00014339|Drug|Wobe-Mugos E|
12068793|NCT00014339|Drug|melphalan|
12068794|NCT00014339|Drug|prednisone|
12068795|NCT00014339|Procedure|quality-of-life assessment|
12068796|NCT00012259|Drug|troxacitabine|
12068797|NCT00010179|Drug|lurtotecan liposome|
12068798|NCT00006472|Drug|carboplatin|Carboplatin AUC 6 days 1 and 22
12068799|NCT00006472|Drug|fluorouracil|5FU 225mg/m2 continuous infusion on days 1-42 during radiation
12068800|NCT00006472|Drug|paclitaxel|taxol
12068801|NCT00006472|Procedure|conventional surgery|
12068802|NCT00006472|Radiation|radiation therapy|The initial fields should be treated AP:PA when possible to a dose of 4500 cGy in 180 cGy fractions
12068803|NCT00006365|Radiation|brachytherapy|
12068804|NCT00006365|Radiation|iodine I 125|
12068805|NCT00006365|Radiation|radiation therapy|
12068806|NCT00006108|Biological|trastuzumab|
12068811|NCT00006037|Drug|oglufanide disodium|
12068812|NCT00006014|Drug|semaxanib|
12068813|NCT00078403|Drug|Peginterferon alfa-2a|180 mcg PEG-IFN subcutaneously
12068814|NCT00078403|Drug|Ribavirin|One tablet or capsule containing ribavirin 200 mg
12068815|NCT00078325|Drug|Armodafinil 250 mg/day|Armodafinil 250 mg once daily in the morning
12068816|NCT00078325|Drug|Armodafinil 150 mg/day|Armodafinil 150 mg once daily in the morning
12068817|NCT00078325|Drug|Placebo|Matching placebo tablets once daily in the morning
12068818|NCT00078312|Drug|CEP-10953 (Armodafinil)|Armodafinil (po) 100 to 250 mg/day up to 12 months
12068819|NCT00005991|Drug|gemcitabine hydrochloride|
12068820|NCT00005991|Drug|pegylated liposomal doxorubicin hydrochloride|
12068821|NCT00005880|Drug|budesonide|
12068822|NCT00005869|Drug|gemcitabine hydrochloride|
12068823|NCT00005869|Drug|rubitecan|
12068824|NCT00005864|Drug|chloroquinoxaline sulfonamide|
12068825|NCT00005593|Drug|carboplatin|Patients receive carboplatin IV continuously over 30 minutes on days 1-5. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.
12068826|NCT00005593|Drug|fludarabine phosphate|Patients receive fludarabine IV over 30 minutes on days 1-5. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.
12068827|NCT00005593|Drug|topotecan hydrochloride|This is a dose escalation study of topotecan. Patients receive topotecan IV continuously on days 6-8. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.
12068828|NCT00005075|Procedure|high-intensity focused ultrasound ablation|
12068829|NCT00005026|Drug|carboplatin|
12068830|NCT00005026|Drug|paclitaxel|
12068831|NCT00005026|Drug|topotecan hydrochloride|
12068832|NCT00004223|Drug|docetaxel|
12068833|NCT00004223|Drug|gemcitabine hydrochloride|
12068834|NCT00004216|Biological|salmonella VNP20009|
12068835|NCT00004216|Drug|cefixime|
12068836|NCT00004216|Drug|ceftriaxone sodium|
12068837|NCT00004216|Drug|ciprofloxacin|
12068838|NCT00004216|Drug|trimethoprim-sulfamethoxazole|
12068839|NCT00004183|Drug|capecitabine|
12068840|NCT00078364|Procedure|MRI|
12068841|NCT00078351|Procedure|High molecular weight hylan (Synvisc) injection|
12068842|NCT00078286|Drug|Sertraline|Dosage ranging from 50 mg to 200 mg once a day
12068843|NCT00078286|Drug|Placebo|Dosage ranging from 50 mg to 200 mg once a day
12068844|NCT00078273|Behavioral|Personalized Feedback Intervention|Sessions lasted for 60-90 minutes and used Motivational Interviewing (MI) to facilitate discussion of feedback from participants' survey responses. Sessions began with open-ended questions about contextual factors associated with participants' gambling, then review of each feedback section: gambling pattern; perceived gambling norms; positive expectancies and negative consequences of gambling; beliefs about control over gambling; and situational self-efficacy to avoid gambling. Participants were encouraged to consider the feedback in light of their personal goals. All participants received a copy of their feedback, a list of skills for limiting gambling and a resource/referral list.
12068845|NCT00078273|Behavioral|Cognitive Behavioral Intervention|Participants completed either six weekly 1-hour sessions or attend four sessions containing the same content. Sessions covered functional analysis and gambling triggers; challenging cognitive distortions, with emphasis on illusions of control; coping with triggers; assertiveness; and relapse prevention. Participants received a pamphlet covering each week's topic (which was reviewed with the participant if a session was missed), as well as homework sheets and gambling diaries. CBI participants were asked to refrain from gambling for the duration of the group to provide an opportunity to practice and develop skills applicable to gambling and other behavior change situations.
12068846|NCT00078260|Drug|pemetrexed|"A: 500 mg/m2, IV, q 21 days until disease progression
~B: 900 mg/m2, IV, q 21 days until disease progression"
12068847|NCT00078247|Drug|Abacavir|300 mg tablet taken orally twice daily
12068848|NCT00078247|Drug|Lamivudine|300 mg tablet taken orally daily
12068849|NCT00078247|Drug|Zidovudine|300 mg tablet taken orally twice daily
12068850|NCT00078247|Drug|Tuberculosis treatment|Tuberculosis treatment
12068851|NCT00078234|Drug|Oblimersen-rituximab-fludarabine|28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab
12068852|NCT00078169|Behavioral|Behavior Therapy|
12068853|NCT00078156|Behavioral|Behavior Therapy|
12068854|NCT00078143|Behavioral|Behavior Therapy|
12068855|NCT00078195|Biological|omalizumab|A minimum equivalent dose of 0.016 mg/kg/IgE (IU/mL) every 4 weeks will be administered. Omalizumab is administered in two separate phases. In the pre-treatment period omalizumab will be administered to condition the participants to an immune tolerance state. Omalizumab will be also administered after RIT and during the maintenance immunotherapy phase.
12068856|NCT00078195|Biological|Placebo omalizumab|The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
12068857|NCT00078195|Biological|Ragweed rush immunotherapy (RIT)|RIT will consist of a series of injections containing ragweed extract. The series of injections will have progressively greater amounts of ragweed extract: starting from the 1:1000 dilution of the maintenance vial and progressing to the 0.3 mL of 1:10 dilution of the maintenance vial or the maximally tolerated amount.
12068858|NCT00078195|Biological|Placebo rush immunotherapy (RIT)|The placebo for rush immunotherapy will contain the diluents and histamine.
12068859|NCT00078195|Biological|Ragweed immunotherapy (IT)|Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
12068860|NCT00078195|Biological|Placebo immunotherapy (IT)|The placebo for immunotherapy will contain the diluents and histamine.
12068861|NCT00078182|Drug|Tenofovir DF|
12068862|NCT00078130|Drug|Buprenorphine/naloxone|
12068863|NCT00078117|Drug|Buprenorphine|
12068864|NCT00078065|Drug|Xcellerated T Cells|
12068865|NCT00004148|Biological|recombinant vaccinia-B7.1 vaccine|
12068866|NCT00003935|Drug|etoposide|
12068867|NCT00003935|Drug|vincristine sulfate|
12068868|NCT00003935|Radiation|radiation therapy|
12068869|NCT00003814|Drug|eflornithine|
12068870|NCT00003766|Drug|O6-benzylguanine|
12068871|NCT00003623|Dietary Supplement|multivitamin|
12068872|NCT00003623|Other|Placebo|
12068873|NCT00003615|Biological|denileukin diftitox|
12068874|NCT00003600|Biological|epoetin alfa|
12068875|NCT00003600|Other|placebo|
12068876|NCT00003573|Biological|filgrastim|
12068877|NCT00003573|Drug|cisplatin|
12068878|NCT00003573|Drug|cyclophosphamide|
12068879|NCT00003573|Drug|etoposide|
12068880|NCT00003573|Drug|vincristine sulfate|
12068881|NCT00003573|Radiation|radiation therapy|
12068882|NCT00003572|Biological|peripheral blood lymphocyte therapy|
12068883|NCT00003572|Drug|mycophenolate mofetil|
12068884|NCT00003572|Drug|tacrolimus|
12068885|NCT00003572|Procedure|allogeneic bone marrow transplantation|
12068886|NCT00003572|Radiation|radiation therapy|
12068887|NCT00003548|Drug|aminocamptothecin colloidal dispersion|
12068888|NCT00003425|Biological|filgrastim|
12068889|NCT00003425|Drug|amifostine trihydrate|
12068890|NCT00003425|Drug|cyclophosphamide|
12068891|NCT00003425|Drug|melphalan|
12068892|NCT00003425|Procedure|peripheral blood stem cell transplantation|
12068893|NCT00003411|Drug|motexafin gadolinium|
12068894|NCT00003411|Radiation|radiation therapy|
12068895|NCT00003299|Drug|cisplatin|
12068896|NCT00003299|Drug|etoposide|
12068897|NCT00003299|Drug|paclitaxel|
12068898|NCT00003240|Drug|cisplatin|
12068899|NCT00003240|Drug|ifosfamide|
12068900|NCT00003240|Drug|mitomycin C|
12068901|NCT00003240|Drug|vinblastine sulfate|
12068902|NCT00003240|Drug|vindesine|
12068903|NCT00003240|Drug|vinorelbine tartrate|
12068904|NCT00003240|Procedure|conventional surgery|
12068905|NCT00003240|Radiation|radiation therapy|
12068906|NCT00003120|Drug|paclitaxel|135 mg/m2 IV every 28 days
12068907|NCT00078104|Procedure|Extraction of wisdom teeth|
12068908|NCT00078026|Drug|Apomine|
12068909|NCT00030602|Biological|PSA prostate cancer vaccine|
12068910|NCT00030602|Biological|incomplete Freund's adjuvant|
12068911|NCT00003089|Drug|amifostine trihydrate|
12068912|NCT00003089|Drug|carboplatin|
12068913|NCT00003089|Drug|paclitaxel|
12068914|NCT00003089|Radiation|radiation therapy|
12068915|NCT00003046|Biological|Recombinant Interleukin-12|Intraperitoneal over 30 minutes once weekly for 4 weeks, repeats every 4 weeks for up to 6 courses
12068916|NCT00003035|Biological|filgrastim|
12068917|NCT00003035|Drug|doxorubicin hydrochloride|
12068918|NCT00003035|Drug|paclitaxel|
12068919|NCT00003035|Drug|tamoxifen citrate|
12068920|NCT00003035|Procedure|surgical procedure|
12068921|NCT00003035|Radiation|radiation therapy|
12068922|NCT00078013|Drug|MCC-135|
12068923|NCT00078000|Drug|SU011248|
12068924|NCT00077987|Drug|SU011248|
12068925|NCT00077974|Drug|SU011248|50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
12068926|NCT00077961|Drug|CAMPATH (alemtuzumab)|
12068927|NCT00077948|Drug|Enoximone|Enoximone administered orally
12068928|NCT00077948|Drug|Metoprolol succinate|Metoprolol succinate administered orally
12068929|NCT00077948|Drug|Placebo to match enoximone|Placebo to match match enoximone administered orally
12068930|NCT00077948|Drug|Placebo to match metoprolol succinate|Placebo to match metoprolol succinate administered orally
12068931|NCT00077935|Drug|Civamide|Cream 0.075%, TID for 52 weeks
12068932|NCT00077844|Drug|Enoxaparin sodium|
12068933|NCT00077883|Drug|TLK286, cisplatin|TLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days).
12068934|NCT00077870|Drug|ocrelizumab|
12068935|NCT00077857|Drug|capecitabine (Xeloda®)|825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
12068936|NCT00077857|Drug|docetaxel (Taxotere®)|75 mg/m^2 intravenous on day 1 of each 3 week cycle
12068937|NCT00077831|Behavioral|neurobehavioral development|observational study of infant and child development
12068938|NCT00077818|Drug|Enoxaparin sodium|
12068939|NCT00077805|Drug|Enoxaparin sodium|
12068940|NCT00077792|Drug|Enoxaparin sodium (XRP4563)|
12068941|NCT00077779|Drug|Adalimumab|
12068942|NCT00077766|Drug|Darbepoetin alfa|Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
12068943|NCT00077766|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
12068944|NCT00077753|Drug|enoxaparin sodium|
12068945|NCT00077727|Drug|Extended-release galantamine hydrobromide|
12068946|NCT00077714|Drug|Paliperidone ER|
12068947|NCT00077688|Drug|TOCOSOL Paclitaxel|
12068948|NCT00076973|Drug|montelukast sodium|Duration of Treatment: 6 months
12068949|NCT00076973|Drug|Comparator: placebo|Duration of Treatment: 6 months
12068950|NCT00027924|Drug|busulfan|
12068951|NCT00027924|Drug|cyclosporine|
12068952|NCT00027924|Drug|fludarabine phosphate|
12068953|NCT00027924|Drug|methotrexate|
12068954|NCT00027924|Procedure|peripheral blood stem cell transplantation|
12068955|NCT00023647|Biological|Synchrotope TA2M|Cancer Vaccine, Immunotherapy
12068956|NCT00023647|Biological|Synchrotope TA2M|Cancer Vaccine, Immunotherapy
12068957|NCT00023647|Biological|Synchrotope TA2M|Cancer Vaccine, Immunotherapy
12068958|NCT00021294|Drug|eflornithine|
12068959|NCT00021294|Drug|triamcinolone|
12068960|NCT00021034|Drug|chemotherapy|
12068961|NCT00021034|Drug|taurolidine|
12068962|NCT00021021|Biological|anti-FLT-1 ribozyme|
12068963|NCT00020917|Biological|cetuximab|
12068964|NCT00020917|Drug|fluorouracil|
12068965|NCT00020917|Drug|irinotecan hydrochloride|
12068966|NCT00020917|Drug|leucovorin calcium|
12068967|NCT00020553|Procedure|psychosocial assessment and care|
12068968|NCT00017459|Drug|cisplatin|
12068969|NCT00017459|Drug|tirapazamine|
12068970|NCT00017459|Drug|vinorelbine tartrate|
12068971|NCT00017199|Drug|bortezomib|
12068972|NCT00017056|Drug|ixabepilone|
12068973|NCT00016172|Drug|pegylated liposomal doxorubicin hydrochloride|
12068974|NCT00016172|Drug|picoplatin|
12068975|NCT00014625|Drug|indisulam|
12068976|NCT00014430|Biological|trastuzumab|"Trastuzumab (INN; trade name Herceptin) is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers.
~The HER receptors are proteins that are embedded in the cell membrane and communicate molecular signals from outside the cell to inside the cell, and turn genes on and off. The HER proteins regulate cell growth, survival, adhesion, migration, and differentiation-functions that are amplified or weakened in cancer cells. In some cancers, notably some breast cancers, HER2 is over-expressed, and causes breast cells to reproduce uncontrollably."
12068977|NCT00014430|Drug|vinorelbine ditartrate|Vinorelbine (trade name Navelbine) is an anti-mitotic chemotherapy drug that is given as a treatment for some types of cancer, including breast cancer and non-small cell lung cancer.
12068978|NCT00008281|Drug|FOLFOX regimen|
12068979|NCT00008281|Drug|fluorouracil|
12068980|NCT00008281|Drug|leucovorin calcium|
12068981|NCT00008281|Drug|oxaliplatin|
12068982|NCT00007878|Drug|bortezomib|Given IV
12068983|NCT00007878|Drug|fluorouracil|Given IV
12068984|NCT00007878|Drug|leucovorin calcium|Given IV
12068985|NCT00007878|Other|pharmacological study|Correlative studies
12068986|NCT00007878|Other|laboratory biomarker analysis|Correlative studies
12068987|NCT00006122|Drug|cytarabine|
12068988|NCT00006122|Drug|etoposide|
12068989|NCT00006122|Drug|gemtuzumab ozogamicin|
12068990|NCT00006122|Drug|idarubicin|
12068991|NCT00006122|Drug|mitoxantrone hydrochloride|
12068992|NCT00005795|Drug|arsenic trioxide|
12068993|NCT00005791|Drug|cisplatin|
12068994|NCT00005791|Drug|fluorouracil|
12068995|NCT00005791|Drug|irinotecan hydrochloride|
12068996|NCT00005631|Biological|filgrastim|
12068997|NCT00005631|Biological|rituximab|
12068998|NCT00005631|Drug|carboplatin|
12068999|NCT00005631|Drug|etoposide|
12069000|NCT00005631|Drug|ifosfamide|
12069001|NCT00005609|Biological|rituximab|
12069002|NCT00005089|Biological|rituximab|375 mg/m^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.
12069003|NCT00005089|Drug|cyclophosphamide|750 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
12069004|NCT00005089|Drug|doxorubicin hydrochloride|50 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
12069005|NCT00005089|Drug|prednisone|100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.
12069006|NCT00005089|Drug|vincristine sulfate|1.4 mg/m^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.
12069007|NCT00005089|Radiation|radiation therapy|4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
12069008|NCT00004152|Drug|iodinated contrast dye|
12069009|NCT00004152|Procedure|computed tomography|
12069010|NCT00004152|Procedure|positron emission tomography|
12069011|NCT00004152|Radiation|fludeoxyglucose F 18|
12069012|NCT00004145|Biological|anti-thymocyte globulin|
12069013|NCT00004145|Drug|cyclophosphamide|
12069014|NCT00004145|Drug|fludarabine phosphate|
12069015|NCT00004145|Procedure|peripheral blood stem cell transplantation|
12069016|NCT00004114|Biological|filgrastim|
12069017|NCT00004114|Drug|cyclophosphamide|
12069018|NCT00004114|Drug|cytarabine|
12069019|NCT00004114|Drug|fludarabine phosphate|
12069020|NCT00004114|Procedure|peripheral blood stem cell transplantation|
12069021|NCT00003916|Radiation|radiation therapy|
12069022|NCT00003916|Radiation|stereotactic radiosurgery|
12069023|NCT00003867|Drug|capecitabine|
12069024|NCT00003867|Drug|irinotecan hydrochloride|
12069025|NCT00003632|Biological|filgrastim|
12069026|NCT00003632|Drug|carmustine|
12069027|NCT00003632|Drug|cytarabine|
12069028|NCT00003632|Drug|etoposide|
12069029|NCT00003632|Drug|melphalan|
12069030|NCT00003632|Drug|methotrexate|
12069031|NCT00003632|Procedure|peripheral blood stem cell transplantation|
12069032|NCT00003582|Drug|amifostine trihydrate|
12069033|NCT00003582|Drug|cisplatin|
12069034|NCT00003582|Drug|fluorouracil|
12069035|NCT00003582|Drug|paclitaxel|
12069036|NCT00003582|Procedure|quality-of-life assessment|
12069037|NCT00003582|Radiation|radiation therapy|
12069038|NCT00003545|Drug|nelarabine|
12069039|NCT00003207|Drug|pegylated liposomal doxorubicin hydrochloride|
12069040|NCT00003207|Drug|PSC 833|
12069041|NCT00003150|Biological|rituximab|
12069042|NCT00003150|Drug|CHOP regimen|
12069043|NCT00003150|Drug|cyclophosphamide|
12069044|NCT00003150|Drug|doxorubicin hydrochloride|
12069045|NCT00003150|Drug|prednisone|
12069046|NCT00003150|Drug|vincristine sulfate|
12069047|NCT00003066|Drug|docetaxel|
12069048|NCT00003066|Drug|estramustine phosphate sodium|
12069050|NCT00003011|Drug|marimastat|10 mg PO BID
12069051|NCT00003011|Drug|Placebo|10 mg PO BID
12069052|NCT00002869|Biological|recombinant interferon alfa|
12069053|NCT00002869|Drug|cytarabine|
12069054|NCT00002869|Drug|hydroxyurea|
12069055|NCT00002868|Biological|filgrastim|
12069056|NCT00002868|Biological|recombinant interferon alfa|
12069057|NCT00002868|Drug|busulfan|
12069058|NCT00002868|Drug|cytarabine|
12069059|NCT00002868|Drug|etoposide|
12069060|NCT00002868|Drug|hydroxyurea|
12069061|NCT00002868|Drug|idarubicin|
12069062|NCT00002868|Procedure|peripheral blood stem cell transplantation|
12069063|NCT00002532|Biological|filgrastim|
12069064|NCT00002532|Drug|asparaginase|
12069065|NCT00002532|Drug|cytarabine|
12069066|NCT00002532|Drug|daunorubicin hydrochloride|
12069067|NCT00002532|Drug|dexamethasone|
12069068|NCT00002532|Drug|etoposide|
12069069|NCT00002532|Drug|idarubicin|
12069070|NCT00002532|Drug|ifosfamide|
12069071|NCT00002532|Drug|leucovorin calcium|
12069072|NCT00002532|Drug|methotrexate|
12069073|NCT00002532|Drug|prednisolone|
12069074|NCT00002532|Drug|vindesine|
12069075|NCT00002531|Drug|asparaginase|
12069076|NCT00002531|Drug|cyclophosphamide|
12069077|NCT00002531|Drug|cytarabine|
12069078|NCT00002531|Drug|daunorubicin hydrochloride|
12069079|NCT00002531|Drug|dexamethasone|
12069080|NCT00002531|Drug|doxorubicin hydrochloride|
12069081|NCT00002531|Drug|etoposide|
12069082|NCT00002531|Drug|ifosfamide|
12069083|NCT00002531|Drug|leucovorin calcium|
12069084|NCT00002531|Drug|mercaptopurine|
12069085|NCT00002531|Drug|methotrexate|
12069086|NCT00002531|Drug|mitoxantrone hydrochloride|
12069087|NCT00002531|Drug|prednisolone|
12069088|NCT00002531|Drug|teniposide|
12069089|NCT00002531|Drug|thioguanine|
12069090|NCT00002531|Drug|vincristine sulfate|
12069091|NCT00002531|Drug|vindesine|
12069092|NCT00002531|Procedure|allogeneic bone marrow transplantation|
12069093|NCT00002531|Procedure|peripheral blood stem cell transplantation|
12069094|NCT00002531|Radiation|radiation therapy|
12069095|NCT00077922|Drug|LMB-2|40 micrograms/kg every other day (QOD) x 3 every 4 weeks
12069096|NCT00077896|Procedure|Direct Current Polarization|
12069097|NCT00077675|Drug|Telavancin|Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
12069098|NCT00077675|Drug|vancomycin or antistaphylococcal penicillin|Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
12069099|NCT00077649|Drug|ribavirin [Copegus]|600mg po bid for 48 weeks
12069100|NCT00077649|Drug|ribavirin [Copegus]|800mg po bid for 48 weeks
12069101|NCT00077649|Drug|peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]|180 micrograms sc weekly for 48 weeks
12069102|NCT00077649|Drug|peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]|270 micrograms sc weekly for 48 weeks
12069103|NCT00077636|Drug|Copegus|400mg po bid for 16 weeks
12069104|NCT00077636|Drug|Copegus|400mg po bid for 24 weeks
12069105|NCT00077636|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 16 weeks
12069106|NCT00077636|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 24 weeks
12069107|NCT00077623|Drug|epoetin alfa or beta|iv 3 times weekly, as prescribed
12069108|NCT00077623|Drug|methoxy polyethylene glycol-epoetin beta (Mircera)|60, 100 or 180 micrograms sc (starting dose) every 2 weeks
12069109|NCT00077623|Drug|methoxy polyethylene glycol-epoetin beta (Mircera)|60, 100 or 180 micrograms sc (starting dose) every 4 weeks
12069110|NCT00077610|Drug|Epoetin alfa or beta|intravenously 3 times weekly for 52 weeks, as prescribed
12069111|NCT00077610|Drug|RO0503821 (1x/2 Weeks)|60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
12069112|NCT00077610|Drug|RO0503821 (1x/4 Weeks)|120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
12069113|NCT00077597|Drug|epoetin|3 times a week iv, as prescribed.
12069114|NCT00077597|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|0.4 micrograms/kg iv (starting dose) once every 2 weeks
12069115|NCT00077558|Drug|fludarabine phosphate|
12069116|NCT00077558|Drug|triapine|
12069117|NCT00077545|Drug|triapine|Given IV
12069118|NCT00077545|Drug|cisplatin|Given IV
12069119|NCT00077532|Biological|gp100 antigen|
12069120|NCT00077532|Biological|incomplete Freund's adjuvant|
12069121|NCT00077532|Biological|ipilimumab|
12069122|NCT00077519|Drug|tipifarnib|
12069123|NCT00077519|Radiation|radiation therapy|
12069124|NCT00077493|Drug|BL22 immunotoxin|BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.
12069125|NCT00077493|Procedure|antibody-drug conjugate therapy|CD22 antibody, RFB4 on day 7
12069126|NCT00077493|Procedure|immunotoxin therapy|tested for immunogenicity to CAT-8015 before each cycle and at end of study.
12069127|NCT00077493|Procedure|monoclonal antibody therapy|administered intravenously over 30 minutes.
12069128|NCT00077467|Drug|bortezomib|Given IV
12069129|NCT00077467|Other|pharmacological study|Correlative studies
12069130|NCT00077467|Other|laboratory biomarker analysis|Correlative studies
12069131|NCT00077454|Drug|erlotinib hydrochloride|Given orally (PO)
12069132|NCT00077454|Drug|temozolomide|Given PO
12069133|NCT00077454|Other|pharmacological study|Correlative studies
12069134|NCT00077454|Other|laboratory biomarker analysis|Correlative studies
12069135|NCT00077441|Drug|bortezomib|Given IV
12069136|NCT00077441|Other|laboratory biomarker analysis|Correlative studies
12069137|NCT00077428|Drug|bortezomib|Given IV
12069138|NCT00077428|Drug|doxorubicin hydrochloride|Given IV
12069139|NCT00077428|Other|laboratory biomarker analysis|Correlative studies
12069140|NCT00077415|Drug|gemcitabine hydrochloride|
12069141|NCT00077415|Drug|triapine|
12069142|NCT00077402|Drug|fenretinide|
12069143|NCT00077389|Drug|carboplatin|
12069144|NCT00077389|Drug|cisplatin|
12069145|NCT00077389|Drug|doxorubicin hydrochloride|
12069146|NCT00077389|Procedure|adjuvant therapy|
12069147|NCT00077389|Procedure|conventional surgery|
12069148|NCT00077389|Procedure|neoadjuvant therapy|
12069149|NCT00077376|Biological|trastuzumab|Given IV
12069150|NCT00077376|Drug|ixabepilone|Given IV
12069151|NCT00077376|Drug|carboplatin|Given IV
12069152|NCT00077376|Other|laboratory biomarker analysis|Correlative studies
12069153|NCT00077363|Drug|tipifarnib|Given PO
12069154|NCT00077363|Drug|capecitabine|Given PO
12069155|NCT00077350|Drug|triapine|Given IV
12069156|NCT00077350|Drug|gemcitabine hydrochloride|Given IV
12069157|NCT00077350|Other|laboratory biomarker analysis|Correlative studies
12069158|NCT00077337|Drug|romidepsin|
12069159|NCT00077324|Genetic|proteomic profiling|
12069160|NCT00077324|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
12069161|NCT00077324|Procedure|biopsy|
12069162|NCT00077324|Procedure|surgery|
12069163|NCT00077311|Biological|darbepoetin alfa|200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
12069164|NCT00077311|Biological|pegfilgrastim|6 mg sub Q day 2 of each cycle
12069165|NCT00077311|Drug|cisplatin|75 mg/sq m IV over 1 hr Day 1 of each cycle
12069166|NCT00077311|Drug|docetaxel|75 mg/sq m IV over 1 hr Day 1 of each cycle
12069167|NCT00077311|Drug|BNP7787|40 g IV over 30 min Day 1 of each cycle
12069168|NCT00007852|Biological|rituximab|Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.
12069169|NCT00007852|Drug|carmustine|BCNU 300 mg/M2 IV day -6
12069170|NCT00007852|Drug|cytarabine|100 mg/m2 on days -5 through -2
12069171|NCT00007852|Drug|etoposide|100mg/M2 BID on days -5 through -2
12069172|NCT00007852|Drug|melphalan|140 mg/m2 IV on day -1
12069173|NCT00007852|Procedure|autologous hematopoietic stem cell transplantation|Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
12069174|NCT00006786|Biological|bevacizumab|
12069175|NCT00006786|Drug|fluorouracil|
12069176|NCT00006786|Drug|irinotecan hydrochloride|
12069177|NCT00006786|Drug|leucovorin calcium|
12069178|NCT00006459|Drug|gemcitabine hydrochloride|
12069179|NCT00006459|Drug|paclitaxel|
12069180|NCT00006388|Drug|tamoxifen citrate|
12069181|NCT00006388|Radiation|radiation therapy|
12069182|NCT00006375|Drug|LY293111|
12069183|NCT00006123|Biological|trastuzumab|
12069184|NCT00006123|Drug|carboplatin|
12069185|NCT00006123|Drug|carmustine|
12069186|NCT00006123|Drug|cisplatin|
12069187|NCT00006123|Drug|cyclophosphamide|
12069188|NCT00006123|Drug|thiotepa|
12069189|NCT00006123|Procedure|peripheral blood stem cell transplantation|
12069190|NCT00006047|Drug|Oral Etoposide|
12069191|NCT00006047|Drug|Oral 9-Nitrocamptothecin|
12069192|NCT00006038|Drug|cisplatin|
12069193|NCT00006038|Drug|docetaxel|
12069194|NCT00006038|Drug|floxuridine|
12069195|NCT00006038|Drug|fluorouracil|
12069196|NCT00006038|Drug|leucovorin calcium|
12069197|NCT00006038|Procedure|conventional surgery|
12069198|NCT00005995|Drug|shark cartilage extract AE-941|
12069199|NCT00005986|Drug|busulfan|
12069200|NCT00005986|Drug|cyclophosphamide|
12069201|NCT00005986|Drug|filgrastim|
12069202|NCT00005986|Drug|recombinant interferon alfa|
12069203|NCT00005986|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12069204|NCT00005986|Procedure|peripheral blood stem cell transplantation|
12069205|NCT00005986|Procedure|radiation therapy|
12069206|NCT00005877|Drug|rubitecan|
12069207|NCT00005862|Drug|semaxanib|
12069208|NCT00005610|Biological|sargramostim|
12069209|NCT00004919|Drug|cisplatin|Given IV
12069210|NCT00004919|Drug|irinotecan hydrochloride|Given IV
12069211|NCT00004919|Drug|amifostine trihydrate|Given IV
12069212|NCT00004919|Other|pharmacological study|Correlative studies
12069213|NCT00004889|Biological|rituximab|375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.
12069214|NCT00004203|Drug|oxaliplatin|
12069215|NCT00004157|Biological|filgrastim|
12069216|NCT00004157|Biological|recombinant interleukin-11|
12069217|NCT00004003|Drug|cisplatin|
12069218|NCT00004003|Drug|fluorouracil|
12069219|NCT00004003|Drug|gemcitabine hydrochloride|
12069220|NCT00077584|Drug|Bosentan 62.5 mg|Oral tablets containing 62.5 mg of bosentan
12069221|NCT00077584|Drug|Bosentan 125 mg|Oral tablets containing 125 mg of bosentan
12069222|NCT00077584|Drug|Placebo|Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets
12069223|NCT00077298|Biological|cetuximab|Given IV
12069224|NCT00077298|Biological|bevacizumab|Given IV
12069225|NCT00077298|Drug|irinotecan hydrochloride|Given IV
12069226|NCT00077298|Other|laboratory biomarker analysis|Correlative studies
12069227|NCT00077285|Biological|filgrastim|
12069228|NCT00077285|Drug|carboplatin|
12069230|NCT00077285|Drug|dexrazoxane hydrochloride|
12069231|NCT00077285|Drug|doxorubicin hydrochloride|
12069232|NCT00077285|Drug|etoposide|
12069233|NCT00077285|Drug|ifosfamide|
12069234|NCT00077285|Drug|irinotecan hydrochloride|
12069235|NCT00077285|Drug|vincristine sulfate|
12069236|NCT00077285|Procedure|conventional surgery|
12069237|NCT00077285|Radiation|radiation therapy|
12069238|NCT00077259|Drug|epothilone D|
12069239|NCT00077246|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
12069240|NCT00077233|Drug|cetuximab|IV
12069241|NCT00077233|Drug|5-FU|IV
12069242|NCT00077233|Drug|irinotecan|IV
12069243|NCT00077233|Drug|leucovorin|IV
12069244|NCT00077233|Drug|oxaliplatin|IV
12069245|NCT00077220|Drug|carboplatin|
12069246|NCT00077220|Drug|paclitaxel|
12069247|NCT00077220|Procedure|adjuvant therapy|
12069248|NCT00077220|Radiation|radiation therapy|
12069249|NCT00077207|Drug|carboplatin|Given IV
12069250|NCT00077207|Drug|temozolomide|Given orally
12069251|NCT00077207|Drug|vincristine sulfate|Given IV
12069252|NCT00077194|Drug|romidepsin|
12069253|NCT00077181|Drug|cytarabine|Given IV
12069254|NCT00077181|Drug|triapine|Given IV
12069255|NCT00077181|Other|laboratory biomarker analysis|Correlative studies
12069256|NCT00077168|Drug|anastrozole|
12069257|NCT00077168|Drug|tamoxifen citrate|
12069258|NCT00077168|Procedure|adjuvant therapy|
12069259|NCT00077168|Radiation|radiation therapy|
12069260|NCT00077155|Drug|cilengitide|
12069261|NCT00077142|Drug|TAC-101|Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.
12069262|NCT00077129|Drug|carboplatin|
12069263|NCT00077129|Drug|paclitaxel|
12069264|NCT00077116|Drug|busulfan|
12069265|NCT00077116|Drug|cyclophosphamide|
12069266|NCT00077116|Drug|cytarabine|
12069267|NCT00077116|Drug|gemtuzumab ozogamicin|
12069268|NCT00077116|Drug|idarubicin|
12069269|NCT00077116|Procedure|allogeneic bone marrow transplantation|
12069270|NCT00077116|Procedure|peripheral blood stem cell transplantation|
12069271|NCT00077116|Radiation|radiation therapy|
12069272|NCT00077103|Biological|filgrastim|filgrastim (G-CSF) subcutaneously (SC) on days 3-21 or pegfilgrastim SC on day 2.
12069273|NCT00077103|Biological|pegfilgrastim|filgrastim (G-CSF) subcutaneously (SC) on days 3-21 or pegfilgrastim SC on day 2.
12069274|NCT00077103|Drug|cisplatin|cisplatin IV over 30-60 minutes on day 1
12069275|NCT00077103|Drug|doxorubicin hydrochloride|doxorubicin IV over 5-10 minutes
12069276|NCT00077103|Drug|fosbretabulin disodium|Combined Modality Phase:Patients also receive CA4P IV over 10 minutes weekly on the fifth day of radiotherapy. Beginning 4-6 weeks after the completion of the combined modality phase, patients receive CA4P IV over 10 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses.
12069277|NCT00077103|Radiation|radiation therapy|Beginning on day 22, patients undergo radiotherapy twice daily, 5 days a week, for 3-4 weeks.
12069278|NCT00077090|Drug|hyperbaric oxygen|
12069279|NCT00077077|Drug|DJ-927|
12069280|NCT00077077|Drug|capecitabine|
12069281|NCT00077064|Drug|captopril|Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).
12069282|NCT00077051|Drug|cisplatin|
12069283|NCT00077051|Drug|cytochlor|
12069284|NCT00077051|Drug|tetrahydrouridine|
12069285|NCT00077051|Radiation|radiation therapy|
12069286|NCT00077025|Drug|Gefitinib|ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
12069287|NCT00077025|Drug|Anastrozole|1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
12069288|NCT00077012|Drug|QLT0074|
12069289|NCT00077012|Drug|Photodynamic therapy|
12069290|NCT00076999|Drug|TPV oral solution|Tipranavir oral solution
12069291|NCT00076999|Drug|TPV oral solution|Tipranavir oral solution
12069292|NCT00076999|Drug|RTV oral solution|Ritonavir oral solution
12069293|NCT00076999|Drug|RTV oral solution|Ritonavir oral solution
12069294|NCT00076986|Drug|IL13-PE38QQR|
12069295|NCT00076986|Procedure|surgery and catheter placement (2 procedures)|
12069296|NCT00076986|Drug|prolifespan 20 with carmustine implant (GLIADEL® Wafer)|
12069297|NCT00076986|Procedure|surgery and wafer placement (1 procedure)|
12069298|NCT00076960|Drug|Stanate (TM) [stannsoporfin, tin-mesoporphyrin]|Treatment with 4.5 mg/kg
12069299|NCT00076947|Biological|EnvPro|
12069300|NCT00076934|Drug|RG2077 (CTLA4-IgG4m)|RG2077
12069301|NCT00003937|Drug|cisplatin|
12069302|NCT00003937|Drug|dexrazoxane hydrochloride|
12069303|NCT00003937|Drug|doxorubicin hydrochloride|
12069304|NCT00003937|Drug|etoposide|
12069305|NCT00003937|Drug|ifosfamide|
12069306|NCT00003937|Drug|methotrexate|
12069307|NCT00003937|Procedure|conventional surgery|
12069308|NCT00003923|Drug|porfimer sodium|
12069309|NCT00003721|Drug|incyclinide|This is a dose escalation study. Patients receive oral COL-3 once daily. Treatment continues in the absence of disease progression and unacceptable toxic effects. Cohorts of 3-6 patients each receive escalating doses of COL-3. Dose escalation to the next level occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity (DLT). Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT.
12069310|NCT00003665|Biological|dendritic cell-MART-1 peptide vaccine|
12069311|NCT00003665|Biological|gp100 antigen|
12069312|NCT00003665|Biological|therapeutic tumor infiltrating lymphocytes|
12069313|NCT00003665|Biological|tyrosinase peptide|
12069314|NCT00003616|Drug|irinotecan hydrochloride|
12069315|NCT00003370|Drug|irofulven|
12069316|NCT00003367|Dietary Supplement|green tea|
12069317|NCT00003367|Dietary Supplement|soy protein isolate|
12069318|NCT00003367|Dietary Supplement|vitamin E|
12069319|NCT00003334|Drug|paclitaxel|
12069320|NCT00003334|Drug|pegylated liposomal doxorubicin hydrochloride|
12069321|NCT00003222|Biological|aldesleukin|Systemic subcutaneous delivery of low-dose IL-2.
12069322|NCT00003222|Biological|gp100 antigen|
12069323|NCT00003222|Biological|incomplete Freund's adjuvant|
12069324|NCT00003222|Biological|sargramostim|
12069325|NCT00003222|Biological|tetanus peptide melanoma vaccine|
12069326|NCT00003222|Biological|tyrosinase peptide|
12069327|NCT00003185|Biological|autologous tumor cell vaccine|
12069328|NCT00003185|Biological|sargramostim|
12069329|NCT00003185|Biological|tumor-draining lymph node lymphocyte therapy|
12069330|NCT00003185|Drug|cyclophosphamide|
12069331|NCT00003185|Procedure|conventional surgery|
12069332|NCT00003108|Drug|bryostatin 1|
12069333|NCT00003108|Drug|cisplatin|
12069334|NCT00003086|Biological|filgrastim|
12069335|NCT00003086|Drug|CAF regimen|
12069336|NCT00003086|Drug|carboplatin|
12069337|NCT00003086|Drug|cisplatin|
12069338|NCT00003086|Drug|cyclophosphamide|
12069339|NCT00003086|Drug|doxorubicin hydrochloride|
12069340|NCT00003086|Drug|fluorouracil|
12069341|NCT00003086|Drug|ifosfamide|
12069342|NCT00003086|Drug|melphalan|
12069343|NCT00003086|Drug|paclitaxel|
12069344|NCT00003086|Drug|thiotepa|
12069345|NCT00003086|Procedure|peripheral blood stem cell transplantation|
12069346|NCT00003086|Radiation|samarium Sm 153 lexidronam pentasodium|
12069347|NCT00076869|Drug|MK0991, caspofungin acetate|
12069348|NCT00076869|Drug|Comparator: amphotericin B|
12069349|NCT00076869|Drug|Comparator: lipid formulation of amphotericin B and/or azole|
12069350|NCT00076856|Drug|Temozolomide|
12069351|NCT00076817|Biological|ALVAC-HIV (vCP205)|Canarypox virus vector vaccine
12069352|NCT00076817|Biological|ALVAC-HIV (vCP205)|Canarypox virus vector vaccine placbo
12069353|NCT00076804|Behavioral|Directly Observed Therapy|Use of a patient nominated peer supporter who will observe the morning dose of ARVs
12069354|NCT00076791|Drug|Emtricitabine/Tenofovir disoproxil fumarate|900 mg of TDF combined with 600 mg emtricitabine
12069355|NCT00076791|Drug|Tenofovir disoproxil fumarate|600 mg oral dose of TDF
12069356|NCT00033592|Other|placebo|
12069357|NCT00033592|Drug|bupropion hydrochloride|
12069358|NCT00033592|Drug|nicotine|
12069359|NCT00026377|Drug|bicalutamide|50 mg daily for 1 month
12069360|NCT00026377|Drug|flutamide|250 mg 3 times daily for 1 month
12069361|NCT00026377|Drug|goserelin acetate|3.6 mg once a month for 4 months
12069362|NCT00026377|Drug|leuprolide acetate|7.5 mg once a month for 4 months
12069363|NCT00026377|Drug|SU5416|IV infusion at assigned dose
12069364|NCT00026377|Radiation|radiation therapy|daily for 5 days each week
12069365|NCT00024362|Drug|BBR 3464|
12069366|NCT00024011|Drug|bortezomib|Given IV
12069367|NCT00024011|Other|laboratory biomarker analysis|Correlative studies
12069368|NCT00003320|Procedure|surgical procedure|
12069369|NCT00003320|Radiation|radiation therapy|
12069370|NCT00003320|Radiation|stereotactic radiosurgery|
12069371|NCT00003073|Drug|liposomal cytarabine|
12069372|NCT00002801|Drug|leucovorin calcium|
12069373|NCT00002801|Drug|tegafur-uracil|
12069374|NCT00002801|Radiation|radiation therapy|
12069375|NCT00002679|Biological|filgrastim|
12069376|NCT00002679|Drug|cyclophosphamide|
12069377|NCT00002679|Drug|doxorubicin hydrochloride|
12069378|NCT00002679|Drug|paclitaxel|
12069379|NCT00002679|Drug|tamoxifen citrate|
12069380|NCT00002679|Radiation|radiation therapy|
12069381|NCT00076843|Drug|Hu MiK-Beta-1|
12069382|NCT00076726|Drug|Infliximab|
12069383|NCT00076544|Drug|Ziconotide|
12069384|NCT00076518|Drug|Fenofibrate|
12069385|NCT00076518|Drug|Fish Oil|
12069386|NCT00022373|Drug|iseganan HCl oral solution|
12069387|NCT00022373|Procedure|management of therapy complications|
12069388|NCT00022243|Drug|batabulin sodium|
12069389|NCT00022204|Dietary Supplement|vitamin E|
12069390|NCT00022204|Drug|pentoxifylline|
12069391|NCT00022204|Procedure|quality-of-life assessment|
12069392|NCT00021385|Drug|carboplatin|
12069393|NCT00021385|Drug|squalamine lactate|
12069394|NCT00020696|Drug|cisplatin|
12069395|NCT00020696|Drug|tirapazamine|
12069396|NCT00017407|Biological|ISIS 3521|
12069397|NCT00017407|Drug|carboplatin|
12069398|NCT00017407|Drug|paclitaxel|
12069399|NCT00014105|Drug|carboplatin|
12069400|NCT00014105|Drug|temozolomide|
12069401|NCT00014066|Drug|hematoporphyrin derivative|
12069402|NCT00014066|Radiation|brachytherapy|
12069403|NCT00010244|Radiation|radiation therapy|
12069404|NCT00076752|Drug|fludarabine phosphate|Conditioning and transplant regimen: 30 mg/m^2 day intravenous infusion over 30 minutes daily, 4 days (transplant days -6, -5, -4, -3)
12069405|NCT00076752|Drug|cyclophosphamide|Priming regimen: 2000 mg/m^2 intravenous infusion over 2 hours, day 2. Conditioning and transplant regimen: 1200 mg/m^2 day intravenous infusion daily, 4 days (-6, -5, -4, -3).
12069406|NCT00076752|Biological|Rituxan (rituximab)|Priming regimen: 375 mg/m^2 intravenous day 1, 4. Conditioning and transplant regimen: 750 mg/m^2 intravenous infusion, day -7.
12069407|NCT00076752|Biological|filgrastim|Priming regimen: 10 micrograms/kg/day subcutaneous, starting day 6. Conditioning and transplant regimen: 5 micrograms/kg/day subcutaneous, day +1 until ANC >500 microliters.
12069408|NCT00076752|Drug|methylprednisolone|Priming regimen:1000 mg intravenous over 30 minutes, day 1.
12069409|NCT00076752|Other|immunologic technique|Lymphoablative regimen using cyclophosphamide, rituximab, and fludarabine followed by a CD34 cell selected autologous stem cell transplant.
12069498|NCT00003578|Procedure|autologous bone marrow transplantation|
12069410|NCT00076752|Other|laboratory biomarker analysis|Standard human immunology research laboratory ex vivo studies.
12069411|NCT00076752|Procedure|autologous hematopoietic stem cell transplantation|Day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
12069412|NCT00076752|Drug|Diphenhydramine|Conditioning and transplant regimen 25-50 mg orally or intravenously.
12069413|NCT00076752|Drug|Mesna|Priming regimen: 600 mg/m^2 intravenous immediately prior to cyclophosphamide and repeat at 4 and 7 hours after the first dose, day 2. Conditioning and transplant regimen:1200 mg/m^2 per day continuous 24 hour intravenous infusion, daily for 4 days, start concurrently with the start of cyclophosphamide.
12069414|NCT00009997|Biological|trastuzumab|
12069415|NCT00009997|Drug|cyclophosphamide|
12069416|NCT00009997|Drug|doxorubicin hydrochloride|
12069417|NCT00009997|Drug|paclitaxel|
12069418|NCT00009997|Drug|tamoxifen citrate|
12069419|NCT00009997|Procedure|conventional surgery|
12069420|NCT00009958|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|Given SC
12069421|NCT00009958|Biological|recombinant vaccinia-CEA(6D)-TRICOM vaccine|Given intradermally
12069422|NCT00009958|Biological|sargramostim|Given SC
12069423|NCT00009958|Other|laboratory biomarker analysis|Correlative studies
12069424|NCT00009906|Drug|Imatinib Mesylate|Given orally
12069425|NCT00008333|Drug|vinorelbine tartrate|
12069426|NCT00008034|Drug|capecitabine|
12069427|NCT00008034|Drug|cyclophosphamide|
12069428|NCT00008034|Drug|epirubicin hydrochloride|
12069429|NCT00006460|Drug|hyperbaric oxygen|
12069430|NCT00006460|Radiation|radiation therapy|
12069431|NCT00006454|Drug|carboplatin|
12069432|NCT00006454|Drug|paclitaxel|
12069433|NCT00006454|Drug|topotecan hydrochloride|
12069434|NCT00006111|Drug|cisplatin|
12069435|NCT00006111|Drug|fluorouracil|
12069436|NCT00006111|Procedure|conventional surgery|
12069437|NCT00006111|Radiation|radiation therapy|
12069438|NCT00006050|Drug|FOLFOX regimen|
12069439|NCT00006050|Drug|fluorouracil|
12069440|NCT00006050|Drug|isolated perfusion|
12069441|NCT00006050|Drug|leucovorin calcium|
12069442|NCT00006050|Drug|oxaliplatin|
12069443|NCT00005881|Other|Quality of Life Forms|Completion of the instrument [Minneapolis-Manchester Quality of Life (MM-QOL)] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials.
12069444|NCT00005792|Drug|etoposide phosphate|Etoposide phosphate 1363 mg/m^2/day IV over 4 hours (total dose 2726 mg/m^2, or 2400 mg/m^2 etoposide equivalents), beginning 24 hours after the completion of the last infusion of topotecan Days -4, -3
12069445|NCT00005792|Drug|melphalan|Melphalan 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2), followed immediately by topotecan. Days -7, -6, -5
12069446|NCT00005792|Drug|topotecan|Topotecan 3.3 mg/m^2/day (starting total dose = 10 mg/m^2 for level 2) IV over 30 minutes. No topotecan will be administered on the first dose level Days -7, -6, -5
12069447|NCT00005792|Procedure|Autologous Stem Cell Rescue|reinfusion of stem cells, Day 0
12069448|NCT00005064|Drug|bortezomib|Given IV
12069449|NCT00076648|Drug|Poly SFH-P Injection|
12069450|NCT00076635|Drug|Interferon gamma-1b|200 mcg, SQ, 3x per week
12069451|NCT00076674|Drug|Intravenous Levodopa|
12069452|NCT00076622|Drug|Antidepressant medication|Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
12069453|NCT00076622|Drug|No antidepressant medication|Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
12069454|NCT00005022|Drug|cisplatin|
12069455|NCT00005022|Drug|etoposide|
12069456|NCT00005022|Radiation|radiation therapy|
12069457|NCT00004862|Biological|filgrastim|
12069458|NCT00004862|Biological|oblimersen sodium|
12069459|NCT00004862|Drug|cytarabine|
12069460|NCT00004862|Drug|fludarabine phosphate|
12069461|NCT00004239|Drug|Compound 506U78|
12069462|NCT00003888|Drug|cisplatin|
12069463|NCT00003888|Drug|docetaxel|
12069464|NCT00003888|Drug|fluorouracil|
12069465|NCT00003888|Radiation|radiation therapy|
12069466|NCT00076609|Drug|PHY906|
12069467|NCT00076609|Drug|capecitabine|
12069468|NCT00076557|Genetic|Adeno-Associated Viral with Human Factor IX|
12069469|NCT00076570|Drug|Sirolimus|
12069470|NCT00076570|Drug|Tacrolimus|
12069471|NCT00076531|Drug|Leuprolide Acetate for Injectable Suspension 22.5 mg|
12069472|NCT00076492|Drug|CoQ10|
12069473|NCT00076492|Drug|GPI 1485|
12069474|NCT00003882|Drug|anhydrovinblastine|
12069475|NCT00003852|Biological|filgrastim|
12069476|NCT00003852|Drug|carboplatin|
12069477|NCT00003852|Drug|cyclophosphamide|
12069478|NCT00003852|Drug|epirubicin hydrochloride|
12069479|NCT00003852|Drug|etoposide|
12069480|NCT00003852|Drug|ifosfamide|
12069481|NCT00003852|Drug|paclitaxel|
12069482|NCT00003852|Drug|thiotepa|
12069483|NCT00003852|Procedure|bone marrow ablation with stem cell support|
12069484|NCT00003852|Procedure|peripheral blood stem cell transplantation|
12069485|NCT00003683|Drug|doxorubicin hydrochloride|
12069486|NCT00003683|Drug|ifosfamide|
12069487|NCT00003682|Drug|doxorubicin hydrochloride|
12069488|NCT00003682|Drug|methylprednisolone|
12069489|NCT00003578|Drug|CHOP regimen|
12069490|NCT00003578|Drug|carmustine|
12069491|NCT00003578|Drug|cyclophosphamide|
12069492|NCT00003578|Drug|cytarabine|
12069493|NCT00003578|Drug|doxorubicin hydrochloride|
12069494|NCT00003578|Drug|etoposide|
12069495|NCT00003578|Drug|melphalan|
12069496|NCT00003578|Drug|prednisone|
12069497|NCT00003578|Drug|vincristine sulfate|
12069499|NCT00003578|Procedure|peripheral blood stem cell transplantation|
12069500|NCT00076453|Device|Lateral wedge orthotic shoe inserts|Customized lateral wedge orthotic shoe inserts
12069501|NCT00076453|Device|Standard orthotic shoe inserts|Neutral orthotic inserts
12069502|NCT00076440|Drug|Leuprolide acetate|
12069503|NCT00076401|Drug|Motexafin gadolinium|
12069504|NCT00076388|Drug|Gefitinib|
12069505|NCT00076388|Drug|Docetaxel|
12069506|NCT00076375|Drug|Nanocrystalline silver cream (NPI)|
12069507|NCT00076362|Drug|Sandostatin LAR|
12069508|NCT00003541|Biological|filgrastim|
12069509|NCT00003541|Drug|CHOP regimen|
12069510|NCT00003541|Drug|carboplatin|
12069511|NCT00003541|Drug|cyclophosphamide|
12069512|NCT00003541|Drug|doxorubicin hydrochloride|
12069513|NCT00003541|Drug|etoposide|
12069514|NCT00003541|Drug|ifosfamide|
12069515|NCT00003541|Drug|prednisone|
12069516|NCT00003541|Drug|vincristine sulfate|
12069517|NCT00003541|Procedure|peripheral blood stem cell transplantation|
12069518|NCT00003541|Radiation|radiation therapy|
12069519|NCT00003418|Drug|exemestane|
12069520|NCT00003418|Drug|tamoxifen citrate|
12069521|NCT00003364|Drug|cisplatin|
12069522|NCT00003364|Drug|cyclophosphamide|
12069523|NCT00003364|Drug|doxorubicin hydrochloride|
12069524|NCT00003364|Drug|etoposide|
12069525|NCT00003364|Drug|vincristine sulfate|
12069526|NCT00003364|Radiation|radiation therapy|
12069527|NCT00003298|Drug|cisplatin|Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.
12069528|NCT00003298|Drug|fluorouracil|Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin
12069529|NCT00003298|Drug|leucovorin calcium|Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.
12069530|NCT00003298|Drug|paclitaxel|Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.
12069531|NCT00003298|Procedure|surgery|"The surgical procedure performed involved a radical subtotal or total gastrectomy.
~A complete surgical resection was required"
12069532|NCT00003298|Radiation|radiation therapy|Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy
12069533|NCT00003287|Drug|FOLFOX regimen|
12069534|NCT00003287|Drug|fluorouracil|
12069535|NCT00003287|Drug|leucovorin calcium|
12069536|NCT00003287|Drug|oxaliplatin|
12069537|NCT00076414|Drug|Acetylcholine|
12069538|NCT00076414|Drug|L-NMMA|
12069539|NCT00076349|Drug|bendamustine and rituximab|Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.
12069540|NCT00076336|Drug|Telbivudine|600mg/day oral tablet for 104 weeks
12069541|NCT00076336|Drug|Lamivudine|100mg/day oral tablet for 104 weeks
12069542|NCT00076336|Drug|Placebo|Telbivudine matching placebo or lamivudine matching placebo tablet.
12069543|NCT00003137|Drug|irinotecan hydrochloride|
12069544|NCT00003007|Biological|recombinant interferon alfa|
12069545|NCT00003007|Biological|sargramostim|
12069546|NCT00003007|Drug|cyclophosphamide|
12069547|NCT00003007|Drug|dexamethasone|
12069548|NCT00003007|Drug|melphalan|
12069549|NCT00003007|Procedure|peripheral blood stem cell transplantation|
12069550|NCT00002840|Drug|lomustine|
12069551|NCT00002840|Drug|procarbazine hydrochloride|
12069552|NCT00002840|Drug|vincristine sulfate|
12069553|NCT00002840|Radiation|radiation therapy|
12069554|NCT00002817|Biological|sargramostim|
12069555|NCT00002817|Biological|vaccinia-GM-CSF vaccine|
12069556|NCT00002748|Biological|gene-modified tumor cell vaccine therapy|
12069557|NCT00002748|Biological|interleukin-2 gene|
12069558|NCT00076323|Drug|Primaquine|
12069559|NCT00076310|Drug|Docetaxel|60 mg/m^2 IV repeated every 21 days.
12069560|NCT00076310|Drug|OSI-774|100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.
12069561|NCT00076310|Drug|Cisplatin|75 mg/m^2 IV every 21 days.
12069562|NCT00076284|Drug|GW873140|
12069563|NCT00076258|Behavioral|SSRI + LD|Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.
12069564|NCT00076258|Behavioral|SSRI + PHD|Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.
12069565|NCT00076245|Behavioral|Light Therapy|Light therapy will involve exposure to bright light twice a day.
12069566|NCT00076245|Behavioral|Cognitive behavioral therapy (CBT)|CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
12069567|NCT00076219|Procedure|renal replacement therapy|renal replacement therapy
12069568|NCT00076206|Drug|CCI-779|
12069569|NCT00076206|Drug|Placebo|
12069570|NCT00076232|Drug|Acyclovir|400 mg tablet taken orally twice daily
12069571|NCT00076232|Drug|Acyclovir placebo|Oral tablet taken twice daily
12069572|NCT00076115|Drug|Risperidone|
12069573|NCT00076180|Biological|Hu-MiK-Beta-1|Hu-MiK-Beta-1 administered as an intravenous infusion over 90- minutes.
12069574|NCT00076089|Drug|Roflumilast|
12069575|NCT00076076|Drug|Roflumilast|
12069576|NCT00033735|Drug|fluorouracil|5-fluorouracil will be administered via central venous catheter or PICC beginning at 250mg/m2/ day as continous infusion for a 28 day period.
12069577|NCT00033735|Drug|Irofulven|Irofulven will be given at 0.55 mg/kg per infusion on Day 1 and and Day 15 every 28 days as a 30 minute iv infusion.
12069578|NCT00027508|Drug|trabectedin|
12069579|NCT00024401|Drug|DHA-paclitaxel|
12069580|NCT00002566|Drug|carboplatin|
12069581|NCT00002566|Drug|cisplatin|
12069582|NCT00002566|Drug|cyclophosphamide|
12069583|NCT00002566|Drug|etoposide|
12069584|NCT00002566|Drug|ifosfamide|
12069585|NCT00002566|Drug|vinblastine sulfate|
12069586|NCT00002566|Procedure|autologous bone marrow transplantation|
12069587|NCT00002566|Procedure|conventional surgery|
12069588|NCT00002566|Procedure|peripheral blood stem cell transplantation|
12069589|NCT00076102|Drug|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
12069590|NCT00076063|Biological|ALVAC-HIV (vCP1452)|experimental vaccine
12069591|NCT00076063|Biological|LIPO-5|experimental vaccine
12069592|NCT00076050|Dietary Supplement|Soy isoflavones|Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
12069593|NCT00076050|Dietary Supplement|Placebo|Placebo soy isoflavones
12069594|NCT00076037|Biological|HIV CTL MEP administered with RC529-SE adjuvant|
12069595|NCT00076037|Drug|GM-CSF|
12069596|NCT00076024|Drug|Placebo|5 mg twice daily [bid] continuous dosing
12069597|NCT00076024|Drug|Docetaxel|Standard of care drug administration
12069598|NCT00076024|Drug|AG-013736 (axitinib)|5mg twice daily [bid] continuous dosing
12069599|NCT00076024|Drug|Docetaxel|Standard of care drug administration
12069600|NCT00076011|Drug|Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor|
12069601|NCT00075998|Drug|"Interferon gamma-1b (Actimmune)"|200 mcg, SQ, 3x per week
12069602|NCT00075972|Behavioral|Mood Tolearance|
12069603|NCT00075972|Behavioral|Mood Management|
12069604|NCT00075972|Drug|Nicotine Replacement therapy|
12069605|NCT00075959|Drug|NXY-059|
12069606|NCT00075946|Biological|rituximab|Given IV
12069607|NCT00024388|Drug|DHA-paclitaxel|
12069608|NCT00022347|Drug|canfosfamide hydrochloride|
12069609|NCT00022321|Drug|gemtuzumab ozogamicin|
12069610|NCT00021333|Biological|filgrastim|
12069611|NCT00021333|Drug|cisplatin|
12069612|NCT00021333|Drug|paclitaxel|
12069613|NCT00021333|Radiation|radiation therapy|
12069614|NCT00021307|Drug|carboplatin|
12069615|NCT00021307|Drug|temozolomide|
12069616|NCT00075933|Drug|ARQ 501|
12069617|NCT00075907|Drug|Efavirenz + 2 NRTIs|
12069618|NCT00075907|Drug|Lopinavir/Ritonavir + 2 NRTIs|
12069619|NCT00075907|Procedure|Therapeutic Drug Monitoring|
12069620|NCT00075894|Drug|L-alanosine|
12069621|NCT00075881|Drug|bortezomib|Given IV
12069622|NCT00075881|Other|laboratory biomarker analysis|Optional correlative studies
12069623|NCT00075868|Drug|octreotide acetate|
12069624|NCT00075868|Other|Placebo|
12069625|NCT00075855|Drug|therapeutic testosterone|
12069626|NCT00075855|Other|placebo|
12069627|NCT00075842|Dietary Supplement|Valeriana officinalis extract|Given orally
12069628|NCT00075842|Other|placebo|Given orally
12069629|NCT00075829|Procedure|One Autologous Transplant|Melphalan will be administered at a dose of 200 mg/m2. Melphalan will be given in one dose infused on Day -2. Melphalan dose is based on ideal body weight (IBW) for patients who weigh 100-120% of their IBW. All patients will receive an autologous graft with a minimum cell dose of 2.0 x 106 CD34+ cells/kg patient weight. Patients will receive ~5 ug/kg/day of Granulocyte-Colony Stimulating Factor (G-CSF) subcutaneously from Day 5 post-transplant until absolute neutrophil count (ANC) > 500/mm3 for two days.
12069630|NCT00075829|Procedure|Non-Myeloablative Allogeneic Transplant|Upon recovery and at least Day 60 post-autograft, patients with an available 6/6 HLA matched sibling will receive an allograft after non-myeloablative conditioning. Day 0 patients will receive Total Body Irradiation (TBI) 2.0 Gy from a linear accelerator ≤ 20 cGy/min, followed by allogeneic peripheral blood stem cell (PBSC) infusion. Commence cyclosporine (CSA) on Day -3 at 5 mg/kg bid PO for a daily dose of 10 mg/kg/day through Day +84 based on actual body weight. Starting on Day 84, patients in partial or complete response with the absence of graph versus host disease (GVHD) will have CSA tapered so the patient will be off CSA by Day 180. Oral administration of Mycophenolate Mofetil will be at a daily dose of 30 mg/kg/day from the evening of Day 0 until Day 27 post-transplant.
12069631|NCT00075829|Procedure|Second Autologous Transplant|Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients without an HLA-matched sibling donor will receive a second autograft, also conditioned with melphalan 200 mg/m2.
12069632|NCT00075829|Drug|Thalidomide|Patients will be initiated on a starting dose of 50 mg/day. The dose will be increased weekly by 50 mg as tolerated to achieve a target dose of 200 mg/day. Patients will be treated for 12 months with thalidomide.
12069700|NCT00075582|Drug|dactinomycin|Given IV
12069701|NCT00075582|Drug|cyclophosphamide|Given IV
12069633|NCT00075829|Drug|Dexamethasone|Patients will receive dexamethasone at a dose of 40 mg per day during Days 1-4 of each month for 12 months. The first dose of dexamethasone to be given the same day the patient starts thalidomide.
12069634|NCT00075829|Behavioral|Observation|One year of observation post-transplants.
12069635|NCT00075816|Biological|Allogeneic bone marrow transplantation|Bone marrow transplant from HLA compatible unrelated donors.
12069636|NCT00075816|Biological|Peripheral blood stem cell transplantation|Peripheral blood transplant from HLA compatible unrelated donors.
12069637|NCT00075803|Drug|Fluconazole|Fluconazole will be administered orally once daily. Fluconazole capsules should be taken at least one hour before or one hour after a meal. If oral drug is not possible, it will be given intravenously once daily in a total volume of 200 mL in patients > 12 years. For adults, each 200 mL infusion will be administered over 2 hours. In patients < 12 years, intravenous doses will be prepared.
12069638|NCT00075803|Drug|Voriconazole|Voriconazole will be administered orally twice daily. Voriconazole capsules should be taken at least one hour before or one hour after a meal. Taken concomitantly with food, bioavailability of voriconazole is reduced. If oral drug is not possible, it will be given intravenously at a dosage of 200 mg every 12 hours over two hours in patients > 12 years. Each voriconazole dose will be diluted to a total volume of 200 mL in patients > 12 years. Volumes of the formulation required to provide 4 mg/kg doses for children age < 12 years.
12069639|NCT00075777|Drug|valproic acid|250 mg by mouth twice a day
12069640|NCT00075764|Drug|anastrozole|Given orally
12069641|NCT00075764|Drug|fulvestrant|Given intramuscularly
12069642|NCT00075751|Drug|gemcitabine hydrochloride|Given IV
12069643|NCT00075751|Drug|carboplatin|Given IV
12069644|NCT00075751|Drug|bortezomib|Given IV
12069645|NCT00075738|Drug|cisplatin|
12069646|NCT00075738|Drug|fluorouracil|
12069647|NCT00075738|Drug|irinotecan hydrochloride|
12069648|NCT00075738|Drug|leucovorin calcium|
12069649|NCT00075725|Drug|cyclophosphamide|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069650|NCT00075725|Drug|cytarabine|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069651|NCT00075725|Drug|daunorubicin hydrochloride|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069652|NCT00075725|Drug|dexamethasone|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069653|NCT00075725|Drug|doxorubicin hydrochloride|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069654|NCT00075725|Drug|leucovorin calcium|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069655|NCT00075725|Drug|mercaptopurine|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069656|NCT00075725|Drug|methotrexate|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069657|NCT00075725|Drug|pegaspargase|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069658|NCT00075725|Drug|prednisone|Given IV or orally
12069659|NCT00075725|Drug|thioguanine|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069660|NCT00075725|Drug|vincristine sulfate|Given IV, orally, intrathecally, intramuscularly, or subcutaneously
12069661|NCT00075725|Radiation|radiation therapy|Patients undergo radiation therapy periodically during study treatment
12069662|NCT00075712|Drug|carboplatin|
12069663|NCT00075712|Drug|paclitaxel|
12069664|NCT00075712|Procedure|adjuvant therapy|
12069665|NCT00075712|Procedure|conventional surgery|
12069666|NCT00075712|Procedure|neoadjuvant therapy|
12069667|NCT00075699|Drug|cisplatin|
12069668|NCT00075699|Drug|mitomycin C|
12069669|NCT00075699|Drug|vincristine sulfate|
12069670|NCT00075699|Drug|vinorelbine tartrate|
12069671|NCT00075699|Procedure|pain therapy|
12069672|NCT00075699|Procedure|psychosocial assessment and care|
12069673|NCT00075699|Procedure|quality-of-life assessment|
12069674|NCT00075686|Biological|cetuximab|Loading dose: Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only). Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 & days 1,8,15,22 of all subsequent cycles
12069675|NCT00075686|Drug|gemcitabine hydrochloride|1000mg/m2 IV over 30 minutes
12069676|NCT00075673|Drug|celecoxib|Patients receive oral celecoxib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
12069677|NCT00075673|Drug|vinorelbine ditartrate|Patients receive oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
12069678|NCT00075660|Drug|triapine|
12069679|NCT00075647|Drug|temsirolimus|Given IV
12069680|NCT00075647|Other|laboratory biomarker analysis|Correlative studies
12069681|NCT00075634|Drug|decitabine|Given IV
12069682|NCT00075634|Drug|doxorubicin hydrochloride|Given IV
12069683|NCT00075634|Drug|cyclophosphamide|Given IV
12069684|NCT00075634|Biological|filgrastim|Given SC
12069685|NCT00075634|Biological|pegfilgrastim|Given SC
12069686|NCT00075634|Other|laboratory biomarker analysis|Correlative studies
12069687|NCT00075634|Other|pharmacological study|Correlative studies
12069688|NCT00075621|Drug|filgrastim|16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection
12069689|NCT00075621|Drug|melphalan|200 mg/kg over 2 days
12069690|NCT00075621|Procedure|autologous peripheral blood stem cell transplantation|autologous peripheral blood stem cell transplantation
12069691|NCT00075608|Biological|filgrastim|16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection
12069692|NCT00075608|Drug|melphalan|140-200 mcg/kg IV over two days
12069693|NCT00075608|Procedure|autologous stem cell transplantation|infusion of previously collected stem cells on Day 0
12069694|NCT00075608|Procedure|stem cell infusion|infusion of previously collected stem cells on Day 0
12069695|NCT00075595|Drug|FOLFIRI regimen|
12069696|NCT00075595|Drug|fluorouracil|
12069697|NCT00075595|Drug|irinotecan hydrochloride|
12069698|NCT00075595|Drug|leucovorin calcium|
12069699|NCT00075582|Procedure|conventional surgery|Some patients may undergo second-look surgery
12069702|NCT00075582|Drug|vincristine sulfate|Given IV
12069703|NCT00075582|Radiation|radiation therapy|Undergo radiotherapy
12069704|NCT00075569|Biological|HspE7|500 micrograms of SGN-00101 (HspE7, Nventa, San Diego, CA) is a novel therapeutic vaccine consisting of a fusion protein containing an M. bovis BCG heat shock protein (Hsp65) covalently linked to the entire sequence of HPV 16 E7.
12069705|NCT00075556|Drug|capecitabine|
12069706|NCT00075556|Procedure|conventional surgery|
12069707|NCT00075556|Procedure|neoadjuvant therapy|
12069708|NCT00075556|Radiation|radiation therapy|
12069709|NCT00075543|Drug|docetaxel|
12069710|NCT00075543|Drug|oxaliplatin|
12069711|NCT00075517|Drug|docetaxel|
12069712|NCT00075517|Drug|gemcitabine hydrochloride|
12069713|NCT00075504|Drug|triapine|Given IV
12069714|NCT00075504|Drug|gemcitabine|Given IV
12069715|NCT00075491|Drug|fenretinide|Given orally
12069716|NCT00075491|Procedure|therapeutic conventional surgery|Undergo surgery
12069717|NCT00075491|Other|pharmacological study|Correlative studies
12069718|NCT00075491|Other|laboratory biomarker analysis|Correlative studies
12069719|NCT00075478|Procedure|Total-Body Irradiation|Undergo TBI
12069720|NCT00075478|Drug|Fludarabine Phosphate|Given IV
12069721|NCT00075478|Drug|Mycophenolate Mofetil|Given PO
12069722|NCT00075478|Drug|Cyclosporine|Given PO
12069723|NCT00075478|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo transplantation
12069724|NCT00075465|Drug|docetaxel|
12069725|NCT00075465|Drug|epirubicin hydrochloride|
12069726|NCT00075452|Drug|gemcitabine hydrochloride|
12069727|NCT00075452|Drug|oxaliplatin|
12069728|NCT00075439|Drug|gefitinib|Given orally
12069729|NCT00075439|Other|laboratory biomarker analysis|Correlative studies
12069730|NCT00075426|Drug|arsenic trioxide|
12069731|NCT00075413|Drug|arsenic trioxide|
12069732|NCT00075400|Drug|imatinib mesylate|Given PO
12069733|NCT00075400|Other|laboratory biomarker analysis|Correlative studies
12069734|NCT00075387|Drug|Carboplatin|Given IA
12069735|NCT00075387|Drug|Cyclophosphamide|Given IV
12069736|NCT00075387|Drug|Etoposide Phosphate|Given IV
12069737|NCT00075387|Other|Quality-of-Life Assessment|Ancillary studies
12069738|NCT00075387|Drug|Sodium Thiosulfate|Given IV
12069739|NCT00075374|Drug|docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
~OR Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
~Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion.
~Patients are followed at 1 month and then every 2-3 months thereafter."
12069740|NCT00075348|Genetic|mutation analysis|
12069741|NCT00075335|Drug|AMD3100 (Mozobil plerixafor)|AMD 3100 (Mozobil plerixafor)mobilized peripheral blood hematopoietic progenitor cells from healthy volunteers will be characterized by cellular content and immunological properties.
12069742|NCT00075283|Device|Lokomat (Robotic Orthosis) combined with slat belt treadmill|
12069743|NCT00075270|Drug|Paclitaxel|Active Comparator
12069744|NCT00075270|Drug|GW572016 (Lapatinib)|Oral GW572016 Lapatinib
12069745|NCT00075257|Drug|DVS-233 SR|
12069746|NCT00075231|Drug|Kaletra® (lopinavir/ritonavir)|
12069747|NCT00075231|Drug|Combivir® (lamivudine, zidovudine)|
12069748|NCT00075231|Drug|Sustiva® (efavirenz)|
12069749|NCT00075218|Drug|Placebo|50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
12069750|NCT00075218|Drug|SU011248|50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
12069751|NCT00020787|Biological|G17DT Immunogen|Dose: 500 micrograms in 0.2mL Route: Deep intramuscular Schedule: Days 8, 36, and 64; an additional dose at week 2, cycle 7 will be administered
12069752|NCT00020787|Drug|cisplatin|dose: 100 mg/m2 Route: i.v. infusion in 500 mL in 0.9% NaCl administered up to 3 hours Schedule: day 1, and then every 4 weeks.
12069753|NCT00020787|Drug|fluorouracil|Dose: 1000mg/m2/day Route: 24-hour continuous infusion in 0.9% NaCl over 5 days Schedule: Day 1 to Day 5 (5-day infusion) and then every 4 weeks
12069754|NCT00017576|Dietary Supplement|calcitriol|
12069755|NCT00017576|Drug|carboplatin|
12069756|NCT00017537|Biological|MVF-HER-2(628-647)-CRL 1005 vaccine|
12069757|NCT00017433|Drug|arsenic trioxide|
12069758|NCT00075244|Drug|Replagal|
12069759|NCT00075192|Drug|CP-675,206 and leuprolide acetate and bicalutamide|
12069760|NCT00075192|Drug|leuprolide acetate and bicalutamide|
12069761|NCT00017082|Drug|oxaliplatin|
12069762|NCT00016237|Biological|tucotuzumab celmoleukin|
12069763|NCT00016198|Drug|FOLFOX regimen|
12069764|NCT00016198|Drug|fluorouracil|
12069765|NCT00016198|Drug|leucovorin calcium|
12069766|NCT00016198|Drug|oxaliplatin|
12069767|NCT00014404|Drug|celecoxib|
12069768|NCT00014287|Drug|gemcitabine hydrochloride|
12069769|NCT00075205|Drug|SR141716 (Rimonabant)|
12069770|NCT00075179|Drug|Nesiritide (Natrecor)|Given initially as a bolus (2 mcg/kg) and than infused for 30 minutes (0.01 mcg/kg/min) during right heart catheterization.
12069771|NCT00075179|Procedure|Right Heart Catheterization|Small tubes placed in neck vein to heart as means of measuring pressure in heart and lungs; treatment with nesiritide delivered during procedure.
12069772|NCT00075166|Procedure|Stereotactic surgery (SRS)|
12069773|NCT00075166|Procedure|Craniotomy|
12069774|NCT00075140|Genetic|Mutation in the gene|
12069775|NCT00075114|Behavioral|Bladder Health Class|A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.
12069776|NCT00075101|Drug|Dexamethosone|10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
12069962|NCT00074269|Biological|therapeutic allogeneic lymphocytes|
12069963|NCT00074269|Drug|cyclosporine|
12069777|NCT00075088|Device|Electrocardiogram (ECG) Intervention|"Pre-hospital electrocardiographic (ECG) monitoring with special software to detect myocardial ischemia and to automatically transmit an ECG to the destination hospital emergency department with a voice alarm announcing Incoming ECG from the field and print out in the ED."
12069778|NCT00075088|Other|Routine Clinical Practice|ECG in the ED as part of routine clinical practice.
12069779|NCT00075075|Drug|Infliximab|
12069780|NCT00075062|Procedure|Flexible Sigmoidoscopy|
12069781|NCT00075062|Procedure|Rectal Biopsy|
12069782|NCT00075049|Biological|RTS,S with AS02A/AS01B adjuvant|
12069783|NCT00014183|Drug|gefitinib|
12069784|NCT00012116|Drug|temozolomide|Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.
12069785|NCT00009919|Drug|semaxanib|Given IV
12069786|NCT00009893|Drug|fluorouracil|
12069787|NCT00009893|Drug|gemcitabine hydrochloride|
12069788|NCT00009893|Drug|leucovorin calcium|
12069789|NCT00075023|Drug|Thalidomide Gel|
12069790|NCT00075023|Drug|Placebo Gel|
12069791|NCT00075010|Drug|Decitabine|15 mg/m^2 by vein over 1 hour times 10 days
12069792|NCT00075010|Drug|Valproic acid|20 mg/kg given orally daily for 10 days
12069793|NCT00074997|Other|Placebo|Single intravenous infusion of placebo.
12069794|NCT00074997|Genetic|OZ1|Single intravenous infusion of OZ1.
12069795|NCT00074997|Genetic|CD34+ cells|Autologous CD34+ cells.
12069796|NCT00009867|Drug|arsenic trioxide|Given IV
12069797|NCT00009698|Biological|aldesleukin|Given SQ and IV
12069798|NCT00006481|Drug|Biafine cream|
12069799|NCT00006481|Procedure|quality-of-life assessment|
12069800|NCT00006481|Radiation|radiation therapy|
12069801|NCT00006480|Biological|aldesleukin|
12069802|NCT00006480|Biological|therapeutic autologous lymphocytes|
12069803|NCT00006480|Drug|chemotherapy|
12069804|NCT00006480|Drug|ganciclovir|
12069805|NCT00074984|Biological|Fabrazyme (agalsidase beta)|1mg/kg Fabrazyme (agalsidase beta) every 2 weeks
12069806|NCT00074984|Biological|Placebo|1 mg/kg placebo intravenously every 2 weeks
12069807|NCT00074971|Drug|Fabrazyme (agalsidase beta)|
12069808|NCT00074958|Biological|Fabrazyme (agalsidase beta)|1 mg/kg every 2 weeks
12069809|NCT00074932|Biological|Myozyme|20 mg/kg
12069810|NCT00074919|Biological|alglucosidase alfa|20 mg/kg qow
12069811|NCT00074906|Drug|Venticute|Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
12069812|NCT00074893|Device|piezoelectric wrist brace|
12069813|NCT00074867|Drug|CP-547,632|
12069814|NCT00074854|Drug|CP-547,632|
12069815|NCT00074841|Drug|Azithromycin/Chloroquine|
12069816|NCT00074841|Drug|Sulfadoxine-Pyrimethamine/Chloroquine|
12069817|NCT00006384|Biological|recombinant interferon alfa|
12069818|NCT00006384|Drug|semaxanib|
12069819|NCT00006353|Drug|temozolomide|
12069820|NCT00006353|Radiation|radiation therapy|
12069821|NCT00006247|Drug|semaxanib|
12069822|NCT00006213|Drug|BMS-214662|Given IV
12069823|NCT00006213|Other|pharmacological study|Correlative studies
12069824|NCT00006213|Other|laboratory biomarker analysis|Correlative studies
12069825|NCT00006104|Biological|trastuzumab|
12069826|NCT00006104|Drug|docetaxel|
12069827|NCT00074828|Drug|LY517717|
12069828|NCT00074828|Drug|enoxaparin|
12069829|NCT00074763|Biological|Platelet Transfusion|All receive both platelets frozen with Thrombosol and fresh random platelets (FRP), order received is randomized, i.e. receive either FRP then Thrombosol or Thrombosol then FRP.
12069830|NCT00074750|Drug|DTGM|Starting dose: 2 mcg/kg by vein three times a week (M,W,F) for two consecutive weeks.
12069831|NCT00074737|Drug|cenersen|cenersen with standard of care
12069832|NCT00074737|Drug|Idarubicin|standard of care for AML
12069833|NCT00074737|Drug|Cytarabine|standard of care Ara-C and High dose Ara-C
12069834|NCT00074724|Procedure|Coronary Artery Bypass|coronary revascularization using arterial or vein conduits
12069835|NCT00074724|Drug|Modern medical management|Therapies with evidence-based recommendations.
12069836|NCT00074724|Device|Dobutamine echocardiography|Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
12069837|NCT00074724|Drug|Optimal medical therapy|All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.
12069838|NCT00006099|Other|immunohistochemistry staining method|
12069839|NCT00006099|Procedure|biopsy|
12069840|NCT00006099|Procedure|immunoscintigraphy|
12069841|NCT00006099|Radiation|indium In 111 monoclonal antibody Hu3S193|
12069842|NCT00006087|Procedure|annual screening|
12069843|NCT00006087|Procedure|bronchoscopic and lung imaging studies|
12069844|NCT00006087|Procedure|comparison of screening methods|
12069845|NCT00006087|Procedure|computed tomography|
12069846|NCT00006087|Procedure|radiography|
12069847|NCT00006087|Procedure|study of high risk factors|
12069848|NCT00006080|Drug|fenretinide|
12069849|NCT00005978|Biological|filgrastim|
12069850|NCT00005978|Drug|carboplatin|
12069851|NCT00005978|Drug|etoposide|
12069852|NCT00005978|Drug|melphalan|
12069853|NCT00005978|Procedure|autologous bone marrow transplantation|
12069854|NCT00005978|Procedure|peripheral blood stem cell transplantation|
12069855|NCT00005978|Radiation|iobenguane I 131|
12069856|NCT00005978|Radiation|radiation therapy|
12069857|NCT00005963|Drug|carboplatin|
12069858|NCT00005963|Drug|docetaxel|
12069964|NCT00074269|Drug|fludarabine phosphate|
12069965|NCT00074269|Drug|melphalan|
12069966|NCT00074269|Drug|methotrexate|
12069967|NCT00074269|Procedure|peripheral blood stem cell transplantation|
12069968|NCT00074243|Drug|CC-8490|
12069859|NCT00074815|Drug|Serotonin reuptake inhibitors management|"Participants are maintained on their optimized dose of SRI for OCD symptoms (see Other Names section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI."
12069860|NCT00074815|Behavioral|Cognitive behavioral therapy by a psychologist|CBT consists of 14 visits over 12 weeks involving: (1) psychoeducation, (2), cognitive training, (3) mapping OCD, and (4) exposure and ritual prevention (EX/RP). The intervention was adapted from March and Mulle (1998) treatment protocol for pediatric OCD.
12069861|NCT00074815|Behavioral|Instructional cognitive behavioral therapy by a psychiatrist|"The psychiatrist who manages medication will also provide instructions in the CBT procedures that have been found to help reduce OCD symptoms, namely EX/RP. MM+I-CBT was constructed as a single-doctor best practice treatment with three primary goals: (1) inclusion of the main psychoeducational and EX/RP components of the full CBT protocol; (2) feasibility of training psychiatrists to perform the CBT component of MM+I-CBT; (3) integration with protocol medication management visits; and (4) feasibility of implementation with the constraints of a busy practice oriented primarily toward pharmacotherapy."
12069862|NCT00074802|Drug|Paroxetine|Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
12069863|NCT00074802|Behavioral|Cognitive behavioral therapy (CBT)|CBT will consist of 16 weekly treatment sessions.
12069864|NCT00074789|Behavioral|Modified Interpersonal Therapy|Psychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions.
12069865|NCT00074789|Behavioral|Attention control/usual care|Participants will receive the usual care for depression.
12069866|NCT00074776|Drug|Lithium|Participants will receive lithium.
12069867|NCT00074776|Drug|Lamotrigine|Participants will receive lamotrigine.
12069868|NCT00074711|Drug|Calcium carbonate|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
12069869|NCT00074711|Drug|Calcium Phosphate|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
12069870|NCT00074698|Drug|FG-3019|
12069871|NCT00074646|Drug|CC-8490|
12069872|NCT00074633|Behavioral|Health at Every Size (HAES)|
12069873|NCT00074633|Behavioral|Diet (Traditional, moderate energy restriction)|
12069874|NCT00074620|Drug|PEG-hirudin|
12069875|NCT00074607|Drug|Gemcitabine|"Schedule
~Induction: At Dose Level 1athe first cohort of patients will receive intrathecal gemcitabine on a weekly basis for a total of 6 weeks. If that is tolerated, the subsequent cohort will receive intrathecal gemcitabine on a twice-weekly basis (Dose Level 1b) for a total of 6 weeks. Subsequent cohorts (Dose Levels 2 - 6) will receive intrathecal gemcitabine on a twice weekly basis for a total of 6 weeks (12 doses).
~In the absence of disease progression or DLT, patients may proceed to consolidation.
~Consolidation: Intrathecal gemcitabine will be administered weekly for a total of 6 doses. The first dose of consolidation will be given 1 week after the last induction dose. In the absence of disease progression or DLT, patients may proceed to maintenance.
~Maintenance: Intrathecal gemcitabine will be given twice monthly for 4 months and monthly thereafter. In the absence of progressive disease or dose-limiting toxicity, the total duration of therapy will be 1 year."
12069876|NCT00074581|Drug|Atazanavir|300 mg taken orally once daily
12069877|NCT00074581|Drug|Didanosine|400 mg taken orally once daily
12069878|NCT00074581|Drug|Efavirenz|600 mg taken orally once daily
12069879|NCT00074581|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
12069880|NCT00074581|Drug|Lamivudine|300 mg taken orally once daily
12069881|NCT00074581|Drug|Lopinavir/Ritonavir|200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
12069882|NCT00074581|Drug|Nevirapine|200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
12069883|NCT00074581|Drug|Stavudine|Dosage depends on weight
12069884|NCT00074581|Drug|Tenofovir disoproxil fumarate|300 mg taken orally once daily
12069885|NCT00074581|Drug|Zidovudine/Lamivudine|150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
12069886|NCT00005959|Biological|filgrastim|
12069887|NCT00005959|Biological|rituximab|
12069888|NCT00005959|Drug|cyclophosphamide|
12069889|NCT00005959|Drug|doxorubicin hydrochloride|
12069890|NCT00005959|Drug|prednisone|
12069891|NCT00005959|Drug|vincristine sulfate|
12069892|NCT00005876|Drug|rubitecan|
12069893|NCT00005646|Drug|paclitaxel|150 mg/sq m IV over 3 hours weekly for 6 weeks per cycle
12069894|NCT00005642|Drug|semaxanib|This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined.
12069895|NCT00005634|Drug|vorinostat|
12069896|NCT00074542|Drug|Epanova™ (Omega-3 Free Fatty Acids)|
12069897|NCT00074529|Drug|MK0677|
12069898|NCT00005598|Drug|amifostine trihydrate|
12069899|NCT00005598|Drug|azacitidine|
12069900|NCT00005592|Biological|90-Y-ibritumomab tiuxetan|IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells. It is used to deliver radiation therapy to kill lymphoma cells. This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
12069901|NCT00005592|Biological|rituximab|Rituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
12070041|NCT00073866|Drug|docetaxel|
12069902|NCT00005592|Radiation|indium In 111 ibritumomab tiuxetan|IDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine. It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion. The physician will then be able to see and evaluate the location and concentration of the antibody in the body.
12069903|NCT00005083|Procedure|conventional surgery|
12069904|NCT00005083|Procedure|magnetic resonance imaging|
12069905|NCT00005083|Procedure|magnetic resonance spectroscopic imaging|
12069906|NCT00004890|Biological|aldesleukin|
12069907|NCT00004890|Drug|Biomed 101|
12069908|NCT00004874|Radiation|tositumomab and iodine I 131 tositumomab|Dosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will receive the therapeutic dose, which consists of an infusion of 450mg of Anti-B1 Antibody followed by an infusion of Iodine-131 Anti-B1 Antibody.
12069909|NCT00074490|Drug|Rituximab|Rituximab: 375 mg/m(2)/day intravenous (IV), day 1 (for cluster of differentiation 20 (CD20+) patients).
12069910|NCT00074490|Drug|Fludarabine|Fludarabine: 30 mg/m(2)/day intravenous (IV), days -6 to -3.
12069911|NCT00074490|Drug|Etoposide|Etoposide: 50 mg/m(2)/day continuous intravenous (CIV), days 1-4.
12069912|NCT00074490|Drug|Doxorubicin|Doxorubicin:10 mg/m(2)/day continuous intravenous (CIV), days 1-4.
12069913|NCT00074490|Drug|Vincristine|Vincristine: 0.4 mg/m(2)/day continuous intravenous (CIV), days 1-4.
12069914|NCT00074490|Drug|Cyclophosphamide|Cyclophosphamide, 300 mg/m(2)/day intravenous (IV), days -6 to -3.
12069915|NCT00074490|Procedure|Peripheral blood stem cell (PBSC) transplantation|PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell.
12069916|NCT00074490|Genetic|T cell donor lymphocyte infusion (DLI) with unmanipulated donor T cells|The dose of the T cells will attempt to be held constant for each study recipient (target dose 2.5 x 10(7) T cells/kg; minimum dose will be 1 x 10(7) T cells/kg).
12069917|NCT00074490|Drug|Prednisone|Prednisone: 60 mg/m(2)/day by mouth (PO), days 1-5.
12069918|NCT00074490|Procedure|Allogeneic hematopoietic stem cell transplant (HSCT)|Allogeneic Hematopoietic Stem Cell Transplant.
12069919|NCT00074490|Drug|Filgrastim|Filgrastim: 5 mcg/kg/day subcutaneous (SC), day 6 (require absolute neutrophil count (ANC) > 1000, two values; or ANC > 5000 cells/ul on one occasion).
12069920|NCT00074490|Genetic|T-Rapa cell Donor Lymphocyte Infusion (DLI)|The dose of T helper 2 (Th2) cells or unmanipulated donor T cells will attempt to be held constant for each study recipient (target dose 2.5 x 10(7) Th2/kg; minimum dose will be 1 x 10(7) Th2/kg).
12069921|NCT00074477|Drug|R092670|
12069922|NCT00074438|Drug|methotrexate|Oral or parenteral repeating dose
12069923|NCT00074438|Drug|rituximab|Intravenous repeating dose
12069924|NCT00074438|Drug|corticosteroids|Intravenous repeating dose
12069925|NCT00074438|Drug|placebo|Intravenous repeating dose
12069926|NCT00074425|Drug|BufferGel|Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of BufferGel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
12069927|NCT00074425|Drug|PRO 2000/5 Gel|Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
12069928|NCT00074425|Drug|Placebo gel|Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
12069929|NCT00074412|Drug|Nevirapine|10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study.
12069930|NCT00074412|Drug|Nevirapine placebo|Oral suspension taken once daily up to 6 months of age
12069931|NCT00074399|Drug|Nevirapine|Tablet taken orally daily. Dosage depends on age and body surface area
12069932|NCT00074399|Drug|Nevirapine placebo|Placebo tablet taken orally daily
12069933|NCT00074373|Other|No intervention; observational|
12069934|NCT00021983|Biological|BL22 immunotoxin|
12069935|NCT00008177|Radiation|iodine I 131 monoclonal antibody BC8|Given IV
12069936|NCT00008177|Radiation|total-body irradiation|Undergo total-body irradiation
12069937|NCT00008177|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplantation
12069938|NCT00008177|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplantation
12069939|NCT00008177|Drug|fludarabine phosphate|Given IV
12069940|NCT00008177|Drug|cyclosporine|Given orally or IV
12069941|NCT00008177|Drug|mycophenolate mofetil|Given orally or IV
12069942|NCT00008177|Other|laboratory biomarker analysis|Correlative studies
12069943|NCT00074334|Biological|TGFa-PE38 immunotoxin|
12069944|NCT00074334|Procedure|conventional surgery|
12069945|NCT00074321|Drug|irinotecan hydrochloride|Given IV
12069946|NCT00074321|Drug|oxaliplatin|Given IV
12069947|NCT00074321|Drug|capecitabine|Given PO
12069948|NCT00074321|Other|laboratory biomarker analysis|Correlative studies
12069949|NCT00074321|Other|pharmacological study|Correlative studies
12069950|NCT00074308|Drug|imatinib mesylate|Given orally
12069951|NCT00074308|Biological|bevacizumab|Given IV
12069952|NCT00074308|Other|pharmacological study|Correlative studies
12069953|NCT00074308|Other|laboratory biomarker analysis|Correlative studies
12069954|NCT00074295|Biological|GVAX lung cancer vaccine|6-7 injections per week in rotating locations for five weeks
12069955|NCT00074282|Biological|rituximab|
12069956|NCT00074282|Drug|cyclophosphamide|
12069957|NCT00074282|Drug|pentostatin|
12069958|NCT00074282|Drug|Alemtuzumab|
12069959|NCT00074269|Biological|anti-thymocyte globulin|
12069960|NCT00074269|Biological|filgrastim|
12069961|NCT00074269|Biological|graft-versus-tumor induction therapy|
12069969|NCT00074230|Biological|Autologous Dendritic Cells loaded with MAGE-A3, MelanA and Survivin|Within cohort 1 patients received the vaccine intradermally; in cohort 2 the route of Administration was intravenous Infusion, half of the patients had additional loading with RNA coding for EL-Selektin; in cohort 3 the vaccines was again infused intravenously, the cells were matured not with MCM.mimic as in cohort 1 and 2 but either with TriMix or MCM-mimic plus CD40L-RNA.
12069970|NCT00074204|Drug|carboplatin|Carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
12069971|NCT00074204|Drug|docetaxel|"Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
~Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
~In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity."
12069972|NCT00074204|Drug|gemcitabine hydrochloride|Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
12069973|NCT00074191|Drug|cytarabine|
12069974|NCT00074191|Drug|dexamethasone|
12069975|NCT00074191|Drug|lomustine|
12069976|NCT00074191|Drug|methotrexate|
12069977|NCT00074191|Drug|procarbazine hydrochloride|
12069978|NCT00074178|Biological|filgrastim|
12069979|NCT00074178|Biological|pegfilgrastim|
12069980|NCT00074178|Drug|cyclophosphamide|
12069981|NCT00074178|Drug|cytarabine|
12069982|NCT00074178|Drug|dexamethasone|
12069983|NCT00074178|Drug|etoposide phosphate|
12069984|NCT00074178|Drug|methotrexate|
12069985|NCT00074165|Drug|Rituxan|Total dose: 375mg/m2 infused IV; Every 4 weeks for up to one year.
12069986|NCT00074165|Drug|Cyclophosphamide|Dose 330mg/m2 x 2 days infused IV; Every 4 weeks for up to 1 year
12069987|NCT00074165|Drug|Etoposide|Dose 200mg/m2 x 2 days infused IV; Every 4 weeks for up to one year. Etoposide phosphate may be given instead.
12069988|NCT00074165|Drug|Etoposide phosphate|Dose 200mg/m2 infused IV x 2 days; Every 4 weeks for up to one year. Etoposide may be given instead.
12069989|NCT00074165|Drug|Carboplatin|Dose: 200mg/m2 x 2 days infused IA with BBBD; Every 4 weeks for up to one year.
12069990|NCT00074165|Drug|Sodium thiosulfate|"Dose: 4 hrs post carboplatin = 20gm/m2;
~Dose: 8 hrs post carboplatin = 16gm/m2
~Infused IV x 2 days"
12069991|NCT00074165|Drug|Neupogen|48 hours after chemotherapy, QD x 7-10 days until WBC greater than 5000. Neulasta (Pegfilgrastim) may be given instead.
12069992|NCT00074165|Drug|Neulasta|Dose: 6mg, 24-72 hours after chemotherapy. Neupogen may be given instead.
12069993|NCT00074165|Drug|Cytarabine|Dose: 40mg on Day 14 following chemotherapy
12069994|NCT00074152|Drug|chemotherapy|Given within 10 weeks after surgery.
12069995|NCT00074152|Radiation|radiation therapy|Given within 6 months after surgery
12069996|NCT00074139|Drug|cyclophosphamide|
12069997|NCT00074139|Drug|docetaxel|
12069998|NCT00074139|Drug|doxorubicin hydrochloride|
12069999|NCT00074100|Drug|amonafide dihydrochloride|
12070000|NCT00074087|Drug|pegylated liposomal doxorubicin hydrochloride|
12070001|NCT00074074|Biological|infliximab|
12070002|NCT00074048|Drug|BL22|Dosing via IV on Days 1,3, and 5.
12070003|NCT00074035|Drug|pentostatin|4 mg/sq m IV infusion over 20-30 min q 2 weeks
12070004|NCT00074022|Biological|GTI-2040|Given IV
12070005|NCT00074022|Drug|docetaxel|Given IV
12070006|NCT00074022|Other|laboratory biomarker analysis|Correlative studies
12070007|NCT00074022|Other|pharmacological study|Correlative studies
12070008|NCT00074009|Drug|bortezomib|
12070009|NCT00073983|Biological|filgrastim|filgrastim
12070010|NCT00073983|Biological|pegfilgrastim|pegfilgrastim
12070011|NCT00073983|Drug|docetaxel|docetaxel
12070012|NCT00073983|Drug|gemcitabine hydrochloride|gemcitabine hydrochloride
12070013|NCT00073983|Genetic|microarray analysis|microarray analysis
12070014|NCT00073983|Other|laboratory biomarker analysis|laboratory biomarker analysis
12070015|NCT00073983|Other|pharmacokinetic study|pharmacokinetic study
12070016|NCT00073970|Drug|celecoxib|400mg, given twice daily
12070017|NCT00073957|Biological|rituximab|
12070018|NCT00073957|Drug|cytarabine|to be used for CNS prophylaxis
12070019|NCT00073957|Drug|liposomal cytarabine|to be used as CNS prophylaxis
12070020|NCT00073957|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12070021|NCT00073944|Drug|forodesine hydrochloride|
12070022|NCT00073931|Biological|filgrastim|5 µg/kg/day subcutaneously
12070023|NCT00073931|Biological|sargramostim|250µg/m2/d subcutaneously
12070024|NCT00073931|Procedure|autologous bone marrow transplantation|autologous stem cells given via central catheter
12070025|NCT00073931|Procedure|peripheral blood stem cell transplantation|autologous stem cells given via central catheter
12070026|NCT00073931|Radiation|tositumomab and iodine I 131 tositumomab|given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with ~10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)
12070027|NCT00073918|Drug|cyclophosphamide|Given IV
12070028|NCT00073918|Drug|etoposide|Given IV
12070029|NCT00073918|Radiation|iodine I 131 tositumomab|Given IV
12070030|NCT00073918|Procedure|quality-of-life assessment|Ancillary study
12070031|NCT00073918|Procedure|peripheral blood stem cell transplantation|Undergo ASCT given via central catheter
12070032|NCT00073905|Drug|capecitabine plus gemcitabine|capecitabine plus gemcitabine
12070033|NCT00073892|Drug|PI-88|250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle
12070034|NCT00073879|Biological|alemtuzumab|
12070035|NCT00073879|Biological|graft-versus-tumor induction therapy|
12070036|NCT00073879|Drug|cyclophosphamide|
12070037|NCT00073879|Drug|fludarabine phosphate|
12070038|NCT00073879|Procedure|allogeneic bone marrow transplantation|
12070039|NCT00073879|Procedure|peripheral blood stem cell transplantation|
12070040|NCT00073866|Drug|celecoxib|
12070042|NCT00073866|Drug|irinotecan hydrochloride|
12070043|NCT00073853|Procedure|Autologous Incubated Macrophages (cell therapy)|
12070044|NCT00073840|Drug|levalbuterol|"Levalbuterol 90 ųg QID (manufacturing sites A or B);
~Racemic Albuterol 180 ųg QID;
~Placebo QID"
12070045|NCT00073827|Drug|levalbuterol tartrate MDI|levalbuterol 90 mcg QID
12070046|NCT00073827|Drug|racemic albuterol MDI|racemic albuterol 180 mcg QID
12070047|NCT00073827|Drug|Placebo|Placebo MDI QID
12070048|NCT00004857|Biological|alemtuzumab|30 mg subQ injection tiw for 6 weeks
12070049|NCT00004857|Drug|fludarabine phosphate|25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13
12070050|NCT00004261|Drug|EF5|
12070051|NCT00004261|Other|flow cytometry|
12070052|NCT00004261|Other|fluorescent antibody technique|
12070053|NCT00004261|Other|immunohistochemistry staining method|
12070054|NCT00004261|Procedure|biopsy|
12070055|NCT00004242|Drug|fluorouracil|
12070056|NCT00004242|Drug|gemcitabine hydrochloride|
12070057|NCT00004242|Drug|oxaliplatin|
12070058|NCT00003927|Biological|filgrastim|
12070059|NCT00003927|Drug|amifostine trihydrate|
12070060|NCT00003927|Drug|cyclophosphamide|
12070061|NCT00003927|Drug|doxorubicin hydrochloride|
12070062|NCT00003927|Drug|paclitaxel|
12070063|NCT00003927|Procedure|peripheral blood stem cell transplantation|
12070064|NCT00073814|Drug|Levalbuterol tartrate MDI|levalbuterol MDI 90 mcg QID
12070065|NCT00073814|Drug|racemic albuterol MDI|racemic albuterol MDI 180 mcg QID
12070066|NCT00073814|Drug|Placebo|Placebo MDI QID
12070067|NCT00073788|Procedure|PET Scans|PET Scan to look for coronary flow reserve, heart rate variability, and carotid ultrasound measures (mean intermediate thickness of the far fall of the carotid artery).
12070068|NCT00003811|Biological|bleomycin sulfate|
12070069|NCT00003811|Drug|amifostine trihydrate|
12070070|NCT00003811|Drug|cisplatin|
12070071|NCT00003811|Drug|etoposide|
12070072|NCT00003811|Procedure|conventional surgery|
12070073|NCT00003777|Drug|amifostine trihydrate|
12070074|NCT00003777|Drug|cisplatin|
12070075|NCT00003777|Drug|fluorouracil|
12070076|NCT00003777|Procedure|surgical procedure|
12070077|NCT00003777|Radiation|radiation therapy|
12070078|NCT00003761|Biological|rV-DF3/MUC1|"- The starting dose for this Phase I study of rV-DF3/MUC1 will be 4.76 x 106 PFU.
~-- Dose escalation will proceed with cohorts of at least 6 patients as follows: Per vaccination
~Level 1 4.76 x 106 PFU
~Level 2 4.76 x 107 PFU
~Level 3 4.76 x 108 PFU"
12070079|NCT00003729|Drug|cytarabine|
12070080|NCT00003729|Drug|fludarabine phosphate|
12070081|NCT00003729|Drug|idarubicin|
12070082|NCT00003734|Drug|flutamide|
12070083|NCT00003734|Drug|triptorelin|
12070084|NCT00003734|Radiation|radiation therapy|
12070085|NCT00073762|Drug|DVS-233 SR|
12070086|NCT00073749|Drug|Inotuzumab ozogamicin [CMC-544]|CMC-544, IV, dose escalation trial
12070087|NCT00073736|Drug|MB07133 300mg/m2/day|7-day continuous infusion in 28-day cycles
12070088|NCT00073736|Drug|MB07133 600 mg/m2/day|7-day continuous infusion in 28-day cycles
12070089|NCT00073736|Drug|MB07133 1200 mg/m2/day|7-day continuous infusion in 28-day cycles
12070090|NCT00073736|Drug|MB07133 1800 mg/m2/day|7-day continuous infusion in 28-day cycles
12070091|NCT00073736|Drug|MB07133 2400 mg/m2/day|7-day continuous infusion in 28-day cycles
12070092|NCT00073723|Drug|ABI-007|
12070093|NCT00003716|Biological|rituximab|
12070094|NCT00003694|Drug|omacetaxine mepesuccinate|Given IV
12070095|NCT00003694|Drug|cytarabine|Given IV
12070096|NCT00003694|Other|laboratory biomarker analysis|Correlative studies
12070097|NCT00003679|Drug|cyclophosphamide|
12070098|NCT00003679|Drug|docetaxel|
12070099|NCT00003679|Drug|doxorubicin hydrochloride|
12070100|NCT00003679|Drug|tamoxifen citrate|
12070101|NCT00003679|Procedure|conventional surgery|
12070102|NCT00003679|Radiation|radiation therapy|
12070103|NCT00003598|Drug|tretinoin|
12070104|NCT00003450|Biological|Ad5CMV-p53 gene|
12070105|NCT00073710|Drug|Zemplar|
12070106|NCT00073710|Procedure|42 Ca carbonate absorption via single tracer method|
12070107|NCT00073710|Drug|Calcijex|
12070108|NCT00073697|Drug|Escitalopram|Participants will receive escitalopram for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months.
12070109|NCT00073697|Behavioral|Interpersonal Psychotherapy|Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
12070110|NCT00073697|Other|Escitalopram plus IPT|Participants whose symptoms become stabilized will continue the initial treatment for another 6 months. Those who do not will have the second treatment added to their regimen until remission occurs.
12070111|NCT00073684|Behavioral|Trauma focused cognitive behavioral therapy (TF-CBT)|This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes.
12070112|NCT00073684|Behavioral|Brief abuse-focused treatment|Participants will receive 8 sessions of TF-CBT with abuse-focused treatment.
12070113|NCT00073684|Behavioral|Brief coping skills treatment|Participants will receive 8 sessions of TF-CBT with brief coping skills treatment.
12070114|NCT00073684|Behavioral|Extended abuse-focused treatment|Participants will receive 16 sessions of TF-CBT with extended abuse-focused treatment.
12070115|NCT00073684|Behavioral|Extended coping skills treatment|Participants will receive 16 sessions of TF-CBT with extended coping skills treatment.
12070116|NCT00073671|Behavioral|Cognitive-behavioral prevention program|Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.
12070117|NCT00073671|Other|Usual care|Participants receive usual care
12070118|NCT00073658|Drug|Citalopram|
12070119|NCT00073658|Drug|Risperidone|
12070120|NCT00073645|Behavioral|Peer/Group CBT|Children will be trained to be more helpful and positive toward other children through role-playing activities.
12070121|NCT00073645|Behavioral|Family/Parents CBT|Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.
12070122|NCT00073632|Behavioral|Acceptance Based Behavioral Therapy|
12070123|NCT00073619|Behavioral|Cognitive-behavioral group therapy|School-based anxiety preventive intervention (cognitive-behavioral group therapy) originally designed for Australian children that was culturally and contextually modified for inner-city children exposed to community violence. Participants received the weekly intervention and rewards for participating in the assessments.
12070124|NCT00003426|Drug|gemcitabine hydrochloride|
12070125|NCT00003426|Radiation|radiation therapy|
12070126|NCT00003414|Biological|aldesleukin|
12070127|NCT00003414|Biological|recombinant interferon gamma|
12070128|NCT00003414|Drug|busulfan|
12070129|NCT00003414|Drug|cyclophosphamide|
12070130|NCT00003414|Drug|cyclosporine|
12070131|NCT00003414|Procedure|peripheral blood stem cell transplantation|
12070132|NCT00003414|Radiation|radiation therapy|
12070133|NCT00003409|Drug|motexafin gadolinium|
12070134|NCT00003409|Radiation|radiation therapy|
12070135|NCT00003388|Biological|filgrastim|
12070136|NCT00003388|Drug|cyclophosphamide|
12070137|NCT00003388|Drug|cytarabine|
12070138|NCT00003388|Drug|methotrexate|
12070139|NCT00003388|Drug|pegylated liposomal doxorubicin hydrochloride|
12070140|NCT00003388|Drug|prednisone|
12070141|NCT00003388|Drug|vincristine sulfate|
12070142|NCT00003388|Radiation|radiation therapy|
12070143|NCT00073593|Drug|Bivalirudin|250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) >300 seconds (s).
12070144|NCT00073593|Drug|Heparin|: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of >300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.
12070145|NCT00073593|Drug|Protamine|Per institutional practice. Batches from hospital stock.
12070146|NCT00073580|Drug|Angiomax (bivalirudin) anticoagulant|): 250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of the procedure with the option to increase or decrease the infusion rate in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT+) >300 seconds. A low-dose infusion could be administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. An initial dose of 0.1 mg/kg IV bolus followed by an IV infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended.
12070147|NCT00073554|Drug|Alfimeprase|
12070148|NCT00073541|Drug|EMD 72000|
12070149|NCT00073528|Drug|Lapatinib (GW572016)|1500 mg orally once a day
12070150|NCT00073528|Drug|Letrozole|2.5 mg orally once a day
12070151|NCT00003387|Drug|carboplatin|
12070152|NCT00003387|Drug|chemotherapy|
12070153|NCT00003387|Drug|paclitaxel|
12070154|NCT00003387|Radiation|radiation therapy|
12070155|NCT00003313|Biological|filgrastim|
12070156|NCT00003313|Drug|amifostine trihydrate|
12070157|NCT00003313|Drug|carboplatin|
12070158|NCT00003313|Drug|paclitaxel|
12070159|NCT00003313|Radiation|radiation therapy|
12070160|NCT00003253|Drug|paclitaxel|
12070161|NCT00003253|Other|antitumor drug screening assay|
12070162|NCT00003202|Drug|cisplatin|
12070163|NCT00003202|Drug|gemcitabine hydrochloride|
12070164|NCT00003202|Radiation|radiation therapy|
12070165|NCT00003191|Drug|fenretinide|
12070166|NCT00073515|Drug|Alfimeprase|
12070167|NCT00073502|Drug|OSI-7904L|
12070168|NCT00073489|Drug|OSI-461|
12070169|NCT00073463|Genetic|tgAAVCF|
12070170|NCT00003167|Biological|Ad5CMV-p53 gene|Given intravesically
12070171|NCT00003130|Drug|paclitaxel|
12070172|NCT00003060|Biological|filgrastim|
12070173|NCT00003060|Drug|busulfan|
12070174|NCT00003060|Drug|cyclophosphamide|
12070175|NCT00003060|Drug|cyclosporine|
12070176|NCT00003060|Drug|methotrexate|
12070177|NCT00003060|Procedure|allogeneic bone marrow transplantation|
12070178|NCT00003037|Drug|cisplatin|
12070179|NCT00003037|Drug|docetaxel|
12070180|NCT00003037|Drug|gemcitabine hydrochloride|
12070181|NCT00002989|Drug|busulfan|
12070182|NCT00002989|Drug|cyclophosphamide|
12070183|NCT00002989|Drug|idarubicin|
12070184|NCT00002989|Drug|melphalan|
12070185|NCT00002989|Radiation|radiation therapy|
12070186|NCT00073476|Drug|traxiprodil (CP-101,606)|
12070187|NCT00073450|Drug|Farnesyl Protein Transferase Inhibitor|
12070188|NCT00073437|Drug|Infliximab|
12070189|NCT00002940|Drug|hydroxyurea|
12070190|NCT00002836|Biological|Filgrastim (G-CSF)|For group one (Filgrastim + Chemotherapy), given under the skin (SC) on day 4 every 12 hours until completion of apheresis; for group two (Filgrastim alone), beginning on day of reinfusion twice a day (bid) until white blood count (WBC) reaches a safe level.
12070191|NCT00002836|Drug|Carmustine|Upon recovery of hematopoiesis patients then receive high by vein (IV) doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days
12070192|NCT00002836|Drug|Cisplatin|As part of CVP chemotherapy treatment by vein (IV) on days 1-3.
12070352|NCT00072384|Drug|etoposide|Given IV
12070193|NCT00002836|Drug|Cyclophosphamide (CTX)|In group one (Filgrastim + Chemotherapy) as part of CVP chemotherapy treatment by vein (IV) on days 1-3; and group two (Filgrastim alone), upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.
12070194|NCT00002836|Drug|Etoposide|CVP chemotherapy treatment IV on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin.
12070195|NCT00002836|Drug|Thiotepa|Upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.
12070196|NCT00002836|Procedure|Peripheral Blood Stem Cell Transplantation|Infusion of stem cells on Day 0.
12070197|NCT00002828|Drug|fluorouracil|
12070198|NCT00002828|Drug|raltitrexed|
12070199|NCT00002812|Drug|asparaginase|Given IV
12070200|NCT00002812|Drug|cyclophosphamide|Given IV
12070201|NCT00002812|Drug|cytarabine|Given IV
12070202|NCT00002812|Drug|daunorubicin hydrochloride|Given IV
12070203|NCT00002812|Drug|dexamethasone|Given IV
12070204|NCT00002812|Drug|doxorubicin hydrochloride|Given IV
12070205|NCT00002812|Drug|idarubicin|Given IV
12070206|NCT00002812|Drug|mercaptopurine|Given IV
12070207|NCT00002812|Drug|methotrexate|Given PO
12070208|NCT00002812|Drug|pegaspargase|Given IV
12070209|NCT00002812|Drug|prednisone|Given PO
12070210|NCT00002812|Drug|thioguanine|Given IV
12070211|NCT00002812|Drug|vincristine sulfate|Given IV
12070212|NCT00002812|Radiation|radiation therapy|
12070213|NCT00002761|Biological|filgrastim|
12070214|NCT00002761|Biological|recombinant interferon gamma|
12070215|NCT00002761|Drug|busulfan|
12070216|NCT00002761|Drug|cyclophosphamide|
12070217|NCT00002761|Drug|cyclosporine|
12070218|NCT00002761|Drug|cytarabine|
12070219|NCT00002761|Drug|idarubicin|
12070220|NCT00002761|Procedure|peripheral blood stem cell transplantation|
12070221|NCT00073411|Drug|duloxetine|
12070222|NCT00073411|Drug|escitalopram|
12070223|NCT00073411|Drug|placebo|
12070224|NCT00073385|Drug|Pivanex|
12070225|NCT00073385|Drug|Docetaxel|
12070226|NCT00073372|Drug|Abciximab|
12070227|NCT00073359|Behavioral|Cognitive Behavioral Therapy|
12070228|NCT00073346|Behavioral|Cognitive Behavioral Treatment|
12070229|NCT00073333|Behavioral|Social Skills Training|Social skills training once per week
12070230|NCT00073333|Behavioral|Exposure Treatment|Exposure once per week
12070231|NCT00073333|Behavioral|Placebo|Placebo
12070232|NCT00073320|Drug|Paliperidone Palmitate|
12070233|NCT00073307|Drug|Sorafenib (Nexavar, BAY43-9006)|Multi Kinase Inhibitor
12070234|NCT00073307|Drug|Placebo|Placebo
12070235|NCT00036920|Drug|canfosfamide hydrochloride|
12070236|NCT00027521|Biological|bleomycin sulfate|
12070237|NCT00027521|Drug|electroporation therapy|
12070238|NCT00025532|Other|iodine I 131 monoclonal antibody CC49-deltaCH2|
12070239|NCT00002561|Biological|bleomycin sulfate|10 units/m2
12070240|NCT00002561|Drug|dacarbazine|375mg/m2
12070241|NCT00002561|Drug|doxorubicin hydrochloride|25mg/m2
12070242|NCT00002561|Drug|vinblastine|6mg/m2
12070243|NCT00002561|Radiation|radiation therapy|35Gy in 20 fractions (daily)
12070244|NCT00073398|Biological|Drug: Hyperacute Lung Cancer Cell Vaccine|At dose levels I IV the vaccine cells will be injected intradermally every four weeks for four cycles. Dosage will vary from a total of 3 x 106 to 100 x 106 HyperAcute -Lung Cancer Vaccine cells administered per vaccination cycle. At dose level V patients will receive injections of the HyperAcute -Lung Cancer Vaccine cells to include one (1) initial priming vaccine dose of 500 x 106 cells followed by seven (7) booster vaccine cell doses of 300 x 106 HyperAcute -Lung Cancer cell vaccine cells every two weeks. In Phase II, patients will receive 300 x 106 HyperAcute -Lung Cancer cell vaccine cells every two weeks for a total of 8 doses (4 months).
12070245|NCT00073294|Behavioral|diet|
12070246|NCT00073281|Procedure|Islet transplantation|
12070247|NCT00073255|Drug|hokt3g1 (ALA-ALA)|
12070248|NCT00073268|Behavioral|Exercise|
12070249|NCT00073242|Drug|Leptin|leptin administration
12070250|NCT00073242|Behavioral|Dietary modification|Subjects lose 10% of body weight via dietary restriction
12070251|NCT00073242|Drug|T3 repletion|administer T3
12070252|NCT00073216|Biological|Clade B gag DNA/PLG and env DNA/PLG Microparticles|
12070253|NCT00073216|Biological|Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant|
12070254|NCT00073203|Drug|R228060|
12070255|NCT00073203|Drug|Placebo and Paroxetine|
12070256|NCT00073177|Drug|Roflumilast|
12070257|NCT00073190|Behavioral|Osteoporosis Education|
12070258|NCT00073164|Drug|Divalproex Sodium Extended-Release Tablets|
12070259|NCT00073164|Drug|Olanzapine|
12070260|NCT00073164|Drug|Risperidone|
12070261|NCT00073151|Drug|ABT-751|
12070262|NCT00073138|Drug|ABT-751|
12070263|NCT00073125|Drug|ABT-510/Thrombospondin-1 mimetic|
12070264|NCT00073112|Drug|ABT-751|
12070265|NCT00073047|Drug|Daclizumab|
12070266|NCT00073034|Drug|EAA-090|
12070267|NCT00073073|Drug|Exemestane|exemestane 25 mg by mouth (PO) every day for two years
12070268|NCT00073073|Dietary Supplement|Calcium carbonate|calcium carbonate 1200 mg PO every day x 2 years
12070269|NCT00073073|Dietary Supplement|Vitamin D|Vitamin D 400 international units PO every day x 2 years
12070270|NCT00073021|Drug|Asacol 800 mg (mesalamine)|tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
12070271|NCT00073021|Drug|Asacol 400 mg (mesalamine)|tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
12070272|NCT00073008|Drug|GW572016 (lapatinib)|tyrosine kinase inhibitor
12070273|NCT00072995|Behavioral|Four Diets Differing in Macronutrient Composition|
12070274|NCT00072995|Behavioral|Diets Low in Saturated Fat|
12070353|NCT00072384|Biological|filgrastim|Given subcutaneously
12070421|NCT00072007|Drug|cyclophosphamide|cyclophosphamide
12070275|NCT00072982|Drug|fish oil|The object of this intervention is to determine whether treatment of rheumatoid arthritis with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Each arm of the study will take 13 capsules daily (divided doses) for 18 months.
12070276|NCT00072982|Drug|borage seed oil|Borage oil 13 capsules divided doses daily for 18 months
12070277|NCT00072982|Drug|combination fish oil and borage seed oil|Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months
12070278|NCT00072943|Drug|anti-Interferon-gamma monoclonal antibody|
12070279|NCT00072930|Biological|MEDI-522|IV at a concentration of 50 mg/mL and 10mL vials
12070280|NCT00072930|Biological|Docetaxel + Prednisone* + Zoledronic Acid|IV 75 mg/m2 IV 3-4 mg 5 mg
12070281|NCT00072904|Drug|Insulin Asparte|Insulin asparte given 0.5 units per carb per meal
12070282|NCT00072904|Drug|Repaglinide|0.5mg tab with meals tid
12070283|NCT00072891|Behavioral|telephone counseling|
12070284|NCT00072969|Drug|Daclizumab|
12070285|NCT00072865|Drug|Pemetrexed|
12070286|NCT00072865|Drug|Carboplatin|
12070287|NCT00072852|Drug|Irinotecan|
12070288|NCT00072839|Drug|ALX-0600|teduglutide
12070289|NCT00072839|Drug|placebo|placebo solution injected subcutaneously
12070290|NCT00072839|Drug|teduglutide 0.05|0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
12070291|NCT00072839|Drug|teduglutide 0.2 mg|0.2 mg/kg/d subcutaneously injected into thigh or abdomen
12070292|NCT00072839|Drug|Teduglutide 0.05 dose|0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
12070293|NCT00072839|Drug|teduglutide 0.1 mg dose|0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen
12070294|NCT00072787|Drug|S-1|
12070295|NCT00072787|Drug|cisplatin|
12070296|NCT00072774|Drug|DVS-233 SR|
12070297|NCT00072761|Procedure|transfusion therapy|Those in the blood transfusion group will receive at least monthly blood transfusion therapy.
12070298|NCT00072748|Drug|EKB-569|
12070299|NCT00072722|Drug|CC-4047|
12070300|NCT00017017|Drug|paclitaxel poliglumex|
12070301|NCT00014677|Biological|interleukin-4 PE38KDEL cytotoxin|
12070302|NCT00014677|Procedure|conventional surgery|
12070303|NCT00014638|Drug|letrozole|
12070304|NCT00014352|Drug|docetaxel|
12070305|NCT00014352|Drug|doxorubicin hydrochloride|
12070306|NCT00014352|Drug|estramustine phosphate sodium|
12070307|NCT00014352|Drug|ketoconazole|
12070308|NCT00014352|Drug|warfarin|
12070309|NCT00072826|Drug|Oxypurinol|
12070310|NCT00072826|Drug|L-NMMA|
12070311|NCT00072826|Drug|Acetylcholine|
12070312|NCT00072709|Drug|TCH346|
12070313|NCT00072683|Drug|tolvaptan|
12070314|NCT00072670|Drug|Trabectedin|Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m^2) weekly as 3-hour infusion or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.
12070315|NCT00012090|Drug|bicalutamide|
12070316|NCT00012090|Drug|goserelin acetate|
12070317|NCT00010309|Biological|MART-1 antigen|
12070318|NCT00010309|Biological|gp100 antigen|
12070319|NCT00008372|Drug|chloroquinoxaline sulfonamide|
12070320|NCT00006367|Biological|filgrastim|
12070321|NCT00006367|Drug|busulfan|
12070322|NCT00006367|Drug|cytarabine|
12070323|NCT00006367|Drug|idarubicin|
12070324|NCT00006367|Procedure|peripheral blood stem cell transplantation|
12070325|NCT00006224|Drug|gemcitabine hydrochloride|
12070326|NCT00072735|Procedure|Electrocardiogram|
12070327|NCT00072657|Behavioral|Cognitive Behavioral Therapy|The CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations. Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each.
12070328|NCT00072657|Behavioral|Tai Chi Chih|Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher. TCC participants will have 50- to 60-minute biweekly sessions during the 12-week study.
12070329|NCT00072657|Behavioral|Health Education Seminar|Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and they will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
12070330|NCT00072631|Drug|Tarceva (Trademark) (erlotinib HCl, OSI-774)|Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash
12070331|NCT00072618|Drug|Exisulind|
12070332|NCT00072501|Procedure|breast imaging study|
12070333|NCT00072501|Procedure|comparison of screening methods|
12070334|NCT00072501|Procedure|magnetic resonance imaging|
12070335|NCT00072501|Procedure|radiomammography|
12070336|NCT00072501|Procedure|ultrasound imaging|
12070337|NCT00072488|Procedure|computed tomography|
12070338|NCT00072488|Procedure|magnetic resonance imaging|
12070339|NCT00072488|Procedure|positron emission tomography|
12070340|NCT00072475|Drug|vatalanib|Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
12070341|NCT00072462|Drug|tamoxifen citrate|Tamoxifen 20mg + Anastrozole placebo
12070342|NCT00072462|Drug|Anastrozole|Anastrozole 1mg + Tamoxifen placebo
12070343|NCT00072449|Biological|rituximab|
12070344|NCT00072436|Drug|gemcitabine hydrochloride|Given IV
12070345|NCT00072436|Drug|alvocidib|Given IV
12070346|NCT00072436|Other|pharmacological study|Correlative studies
12070347|NCT00072410|Radiation|yttrium Y 90 monoclonal antibody Hu3S193|
12070348|NCT00072384|Drug|liposomal vincristine sulfate|Given IV
12070349|NCT00072384|Procedure|cryosurgery|Application of extreme cold to destroy abnormal or diseased tissue.
12070350|NCT00072384|Procedure|laser surgery|Surgery using a laser (instead of a scalpel) to cut tissue
12070351|NCT00072384|Drug|carboplatin|Given IV
12070354|NCT00072358|Biological|anti-GD2 murine IgG3 monoclonal antibody 3F8|The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over ~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started ~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive ~10 cycles.
12070355|NCT00072358|Biological|anti-GD2 murine IgG3 monoclonal antibody 3F8|The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over ~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started ~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive ~10 cycles.
12070356|NCT00072345|Drug|lomustine|
12070357|NCT00072345|Drug|temozolomide|
12070358|NCT00072345|Drug|thalidomide|
12070359|NCT00072332|Drug|cisplatin|
12070360|NCT00072332|Drug|edotecarin|
12070361|NCT00072319|Biological|filgrastim|
12070362|NCT00072319|Drug|cyclophosphamide|
12070363|NCT00072319|Drug|epirubicin hydrochloride|
12070364|NCT00072319|Drug|paclitaxel|
12070365|NCT00072319|Procedure|adjuvant therapy|
12070366|NCT00072319|Procedure|neoadjuvant therapy|
12070367|NCT00072293|Procedure|Axillary lymph node dissection|Axillary lymph node dissection
12070368|NCT00072293|Procedure|No axillary lymph node dissection|Therapeutic conventional surgery
12070369|NCT00072280|Biological|dactinomycin|Given Slow intravenous (IV) push over 1-5 minutes, dose < 1yr 0.025 mg/kg > or = 1 yr 0.045 mg/kg (max dose 2.5 mg) on days 1,22,43 and 64
12070370|NCT00072280|Drug|cyclophosphamide|Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64.
12070371|NCT00072280|Drug|etoposide|Given IV over 1 hour, dose 3.3 mg/kg in normal saline (NS) 10 cc/kg (or to equal 0.4 mg/mL concentration) on days 1-5 of IE cycle.
12070372|NCT00072280|Drug|ifosfamide|Given IV over 1 hour, dose 60mg/kg in D5 1/4 NS 10 cc/kg IV on days 1-5 of IE Cycle
12070373|NCT00072280|Drug|vincristine sulfate|Given IV Push over 1 minute, dose 0.05 mg/kg (max dose 2 mg) on days 1,8,15,22,29,36,43,50,57 and 64
12070374|NCT00072280|Procedure|Conventional Surgery|"Applied only when lesion is resectable. Surgery is the primary means of local control in this study and reasonable attempts at achieving clear margins with an envelope of normal tissue should be undertaken at the initial and/or subsequent resections."
12070375|NCT00072280|Biological|MESNA (mercaptoethane sulfonate)|Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.
12070376|NCT00072280|Biological|Filgrastim|Given IV - Only use filgrastim if chemotherapy has been delayed or modified for hematologic toxicity, or if patient experiences a significant life-threatening toxicity due to bone marrow suppression
12070377|NCT00072267|Drug|7-hydroxystaurosporine|
12070378|NCT00072267|Drug|topotecan hydrochloride|
12070379|NCT00072228|Drug|gemcitabine|
12070380|NCT00072228|Drug|soblidotin|
12070381|NCT00072228|Procedure|chemotherapy|
12070382|NCT00072215|Drug|cisplatin|given IV
12070383|NCT00072215|Drug|ifosfamide|given IV
12070384|NCT00072215|Drug|paclitaxel|given IV
12070385|NCT00072215|Drug|vinblastine|given IV
12070386|NCT00072189|Drug|7-hydroxystaurosporine|Given IV
12070387|NCT00072189|Other|laboratory biomarker analysis|Correlative studies
12070388|NCT00072189|Other|pharmacological study|Correlative studies
12070389|NCT00072176|Drug|temsirolimus|Given IV
12070390|NCT00072176|Other|laboratory biomarker analysis|Correlative studies
12070391|NCT00072163|Drug|temozolomide|Given orally
12070392|NCT00072163|Drug|thalidomide|Given orally
12070393|NCT00072150|Drug|bortezomib|Given IV
12070394|NCT00072137|Biological|Recombinant Fowlpox-TRICOM Vaccine|Given intravesically
12070395|NCT00072137|Biological|Recombinant Fowlpox GM-CSF Vaccine Adjuvant|Given intravesically
12070396|NCT00072137|Procedure|Therapeutic Conventional Surgery|Undergo cystectomy
12070397|NCT00072137|Other|Pharmacological Study|Correlative studies
12070398|NCT00072137|Other|Laboratory Biomarker Analysis|Correlative studies
12070399|NCT00072124|Drug|cisplatin|
12070400|NCT00072124|Drug|dacarbazine|
12070401|NCT00072124|Procedure|conventional surgery|
12070402|NCT00072111|Biological|anakinra|
12070403|NCT00072098|Biological|adenovirus vector|
12070404|NCT00072098|Biological|interleukin-12 gene|
12070405|NCT00072085|Biological|aldesleukin|
12070406|NCT00072085|Biological|gp100 antigen|
12070407|NCT00072085|Biological|incomplete Freund's adjuvant|
12070408|NCT00072072|Drug|celecoxib|
12070409|NCT00072072|Drug|erlotinib hydrochloride|
12070410|NCT00072059|Biological|methoxy polyethylene glycol epoetin beta|
12070411|NCT00072046|Biological|bevacizumab|10mg/kg IV infusion on Days 1 & 15 of each cycle
12070412|NCT00072046|Biological|recombinant interferon alfa|9 million units subQ injection 3 x/week for 4 weeks
12070413|NCT00072033|Drug|Cisplatin and Docetaxel|cisplatin and docetaxel chemo- and radiochemotherapy
12070414|NCT00072020|Drug|zoledronic acid|
12070415|NCT00072020|Procedure|adjuvant therapy|
12070416|NCT00072020|Procedure|neoadjuvant therapy|
12070417|NCT00072007|Biological|filgrastim|filgrastim
12070418|NCT00072007|Biological|rituximab|rituximab
12070419|NCT00072007|Drug|CHOP regimen|CHOP regimen
12070420|NCT00072007|Drug|cladribine|cladribine
12070422|NCT00072007|Drug|doxorubicin hydrochloride|doxorubicin hydrochloride
12070423|NCT00072007|Drug|prednisone|prednisone
12070424|NCT00072007|Drug|vincristine sulfate|vincristine sulfate
12070425|NCT00071994|Drug|gefitinib|Given orally
12070426|NCT00071994|Other|laboratory biomarker analysis|Correlative studies
12070427|NCT00071981|Biological|incomplete Freund's adjuvant|Given by injection
12070428|NCT00071981|Biological|melanoma helper peptide vaccine|Given by injection
12070429|NCT00071981|Biological|multi-epitope melanoma peptide vaccine|Given by injection
12070430|NCT00071981|Biological|sargramostim|Given by injection
12070431|NCT00071981|Biological|tetanus peptide melanoma vaccine|Given by injection
12070432|NCT00071968|Drug|temsirolimus|
12070433|NCT00071968|Procedure|conventional surgery|
12070434|NCT00071968|Procedure|neoadjuvant therapy|
12070435|NCT00071955|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
12070436|NCT00071955|Biological|sargramostim|
12070437|NCT00071942|Biological|recombinant vaccinia-MUC1 vaccine|Given intradermally
12070438|NCT00071942|Biological|recombinant vaccinia-TRICOM vaccine|Given intradermally
12070439|NCT00071942|Other|laboratory biomarker analysis|Correlative studies
12070440|NCT00071942|Procedure|quality-of-life assessment|Ancillary studies
12070441|NCT00071929|Drug|oxaliplatin|
12070442|NCT00003141|Biological|filgrastim|Given IV
12070443|NCT00003141|Drug|carboplatin|Given IV
12070444|NCT00003141|Drug|cisplatin|Given IV
12070445|NCT00003141|Drug|cyclophosphamide|Given IV
12070446|NCT00003141|Drug|etoposide|Given IV
12070447|NCT00003141|Drug|thiotepa|Given IV
12070448|NCT00003141|Drug|vincristine sulfate|Given IV
12070449|NCT00003141|Procedure|conventional surgery|
12070450|NCT00003141|Procedure|peripheral blood stem cell transplantation|
12070451|NCT00072605|Drug|VRC-EBODNA012-00-VP|
12070452|NCT00072592|Drug|Rituximab|
12070453|NCT00072579|Biological|sargramostim|
12070454|NCT00072566|Biological|Bevacizumab|Given IV
12070455|NCT00072566|Drug|Cyclophosphamide|Given PO
12070456|NCT00072566|Other|Laboratory Biomarker Analysis|Correlative studies
12070457|NCT00072553|Drug|celecoxib|
12070458|NCT00072553|Drug|fluorouracil|
12070459|NCT00072553|Drug|leucovorin calcium|
12070460|NCT00072553|Drug|oxaliplatin|
12070461|NCT00072553|Procedure|adjuvant therapy|
12070462|NCT00072553|Procedure|conventional surgery|
12070463|NCT00072553|Procedure|neoadjuvant therapy|
12070464|NCT00072540|Drug|celecoxib|
12070465|NCT00072540|Procedure|anti-cytokine therapy|
12070466|NCT00072540|Procedure|antiangiogenesis therapy|
12070467|NCT00072540|Procedure|biological therapy|
12070468|NCT00072540|Procedure|cancer prevention intervention|
12070469|NCT00072540|Procedure|chemoprevention of cancer|
12070470|NCT00072540|Procedure|enzyme inhibitor therapy|
12070471|NCT00072540|Procedure|growth factor antagonist therapy|
12070472|NCT00072527|Drug|carboplatin|IV
12070473|NCT00072527|Drug|cisplatin|IV
12070474|NCT00072527|Drug|etoposide|IV
12070475|NCT00072527|Drug|irinotecan hydrochloride|IV
12070476|NCT00072527|Radiation|radiation therapy|
12070477|NCT00072514|Drug|gemcitabine hydrochloride|Given IV
12070478|NCT00072514|Drug|carboplatin|Given IV
12070479|NCT00072514|Drug|dexamethasone|Given PO
12070480|NCT00072514|Biological|rituximab|Given IV in CD20-POSITIVE LYMPHOMAS cases
12070481|NCT00071851|Biological|VRC-HIVDNA009-00-VP|
12070482|NCT00071812|Drug|Placebo|Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
12070483|NCT00071812|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
12070484|NCT00071812|Drug|Belimumab 4 mg/kg|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
12070485|NCT00071812|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.
12070486|NCT00071799|Drug|Azacitidine|Azacitidine was injected subcutaneously (SC) at an initial dose of 75mg/m^2/day for 7 days. The 7-day dosing was repeated every 28 days with dose adjustment based on predefined hematology and renal laboratory results. Number of cycles: Azacitidine treatment was to be continued until the end of the study unless treatment was discontinued due to unacceptable toxicity, relapse after complete or partial response, transformation to AML or disease progression.
12070487|NCT00071799|Other|Physician Choice|"Physician Choice was one of three options:
~Best supportive care (BSC) alone,
~Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
~Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).
~All three options included best supportive care"
12070488|NCT00006008|Drug|arsenic trioxide|
12070489|NCT00005964|Biological|filgrastim|
12070491|NCT00005964|Drug|doxorubicin hydrochloride|
12070492|NCT00005964|Drug|etoposide|
12070493|NCT00005964|Drug|prednisone|
12070494|NCT00005964|Drug|vincristine sulfate|
12070495|NCT00005962|Biological|sargramostim|
12070496|NCT00005962|Drug|cyclophosphamide|
12070497|NCT00005962|Drug|cytarabine|
12070498|NCT00005962|Drug|gemtuzumab ozogamicin|
12070499|NCT00005962|Drug|liposomal daunorubicin citrate|
12070500|NCT00005962|Drug|topotecan hydrochloride|
12070501|NCT00005576|Biological|monoclonal antibody Ch14.18|Given IV
12070502|NCT00005576|Drug|isotretinoin|Given orally
12070503|NCT00005576|Biological|aldesleukin|Given IV
12070504|NCT00005576|Biological|sargramostim|Given IV
12070505|NCT00005094|Drug|celecoxib|Given orally
12070506|NCT00005094|Other|placebo|Given orally
12070507|NCT00071890|Drug|Interleukin 2|Three cycles of IL-2 (6 MUI bid during 5 days = one cycle)
12070508|NCT00071890|Drug|HAART|HAART from week 0 to week 24
12070509|NCT00071890|Drug|Treatment interruption|HAART is interrupted from week 24 in both arms
12070510|NCT00071877|Drug|Replagal|
12070511|NCT00005072|Biological|Leuvectin|1000 ug of Leuvectin injected intratumorally
12070512|NCT00005046|Drug|chemotherapy|
12070513|NCT00005046|Drug|paclitaxel|
12070514|NCT00004206|Drug|FOLFOX regimen|
12070515|NCT00004206|Drug|fluorouracil|
12070516|NCT00004206|Drug|leucovorin calcium|
12070517|NCT00004206|Drug|oxaliplatin|
12070518|NCT00004093|Drug|carboplatin|Carboplatin will be dosed at a target AUC of 5, and will be given on day 1 of each cycle
12070519|NCT00004093|Drug|Gemcitabine|Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21-day cycle of induction chemo (following carboplatin on day 1).
12070520|NCT00004093|Drug|paclitaxel|Paclitaxel will be given on day 1 of each week for 6 weeks at a dose of 50 mg/m2.
12070521|NCT00004093|Drug|vinorelbine|Vinorelbine will be given on day 1 of each week for 6 weeks at a starting dose of 10 mg/m2, escalating up to 15 mg/m2 if no dose limiting toxicities are observed.
12070522|NCT00004093|Radiation|radiation therapy|Radiation will be given at a dose ranging between 45 to 66 Gy, depending on patient-specific characteristics.
12070523|NCT00004093|Drug|Navelbine|Navelbine will be administered at a dose of 10-15 mg/m2 in 100 cc NS to be administered over 10 minutes I.V. (one dose weekly during radiation therapy)
12070524|NCT00004093|Drug|Taxol|Taxol will be administered at a dose of 50 mg/m2 in 250 cc of NS or D5W over 60 minutes, following Navelbine (one dose weekly during radiation therapy)
12070525|NCT00071838|Drug|Daclizumab|
12070526|NCT00071773|Procedure|modified-ETDRS photocoagulation|A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
12070527|NCT00071773|Procedure|Mild Macular Grid photocoagulation|A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
12070528|NCT00071760|Drug|GW433908|Fosamprenavir suspension bid
12070529|NCT00071760|Drug|ritonavir|Ritonavir solution bid
12070530|NCT00071747|Drug|lamotrigine|
12070531|NCT00071721|Drug|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
12070532|NCT00071721|Drug|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
12070533|NCT00071708|Drug|Duloxetine Hydrochloride|
12070534|NCT00071695|Drug|Duloxetine Hydrochloride|
12070535|NCT00071695|Drug|Venlafaxine Extended Release|
12070536|NCT00071669|Procedure|Acupuncture|
12070537|NCT00071656|Behavioral|Psychosocial (behavioral) Intervention|
12070538|NCT00071643|Behavioral|Problem Solving Therapy|Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
12070539|NCT00071643|Drug|Escitalopram|Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
12070540|NCT00071643|Other|Placebo|Participants will receive a placebo pill.
12070541|NCT00071630|Behavioral|Cognitive Behavioral Therapy|
12070542|NCT00071617|Behavioral|Youth-Nominated Support Team|
12070543|NCT00071604|Behavioral|Medication Adherence Therapy|
12070544|NCT00071604|Behavioral|Friendly Support Group|
12070545|NCT00071591|Behavioral|Functional Adaptation Skills Training (FAST)|
12070546|NCT00071578|Behavioral|Group Psychotherapy-Negative Emotion Focus|20 weekly sessions, 2 hours, group format
12070547|NCT00071578|Behavioral|Group Psychotherapy- Self-Esteem Focus|20 weekly sessions, 2 hours, group format
12070548|NCT00071552|Drug|Qvar|Qvar (HFA-propelled beclomethasone dipropionate metered dose inhaler) 160 mcg twice daily for 12 weeks
12070549|NCT00071552|Drug|Flovent Diskus|Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler) 200 mcg twice daily for 12 weeks
12070550|NCT00071539|Drug|TP-38|Recombinant chimeric protein
12070551|NCT00071539|Drug|TP38|recombinant chimeric protein
12070552|NCT00004074|Biological|recombinant interleukin-12|Given IV
12070553|NCT00004074|Biological|ABI-007/carboplatin/trastuzumab|Given IV
12070554|NCT00004050|Biological|Leuvectin|Leuvectin injected intratumorally followed by prostatectomy
12070555|NCT00004025|Biological|aldesleukin|
12070556|NCT00004025|Biological|dendritic cell-gp100-MART-1 antigen vaccine|
12070557|NCT00003794|Procedure|psychosocial assessment and care|
12070558|NCT00003794|Procedure|quality-of-life assessment|
12070559|NCT00003648|Genetic|DNA stability analysis|
12070560|NCT00003648|Genetic|gene rearrangement analysis|
12070561|NCT00071513|Behavioral|CAST-T/HSTS|Skills training small group.
12070562|NCT00071513|Behavioral|Brief Intervention|Assessment of needs and referral to services as needed.
12070563|NCT00071500|Device|MedSignals™|An electronic device that is used to improve medication compliance among HIV patients. It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions.
12070564|NCT00071487|Drug|Placebo|Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
12070565|NCT00071487|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
12070566|NCT00071487|Drug|Belimumab 4 mg/kg|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
12070567|NCT00071487|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
12070568|NCT00003595|Biological|filgrastim|
12070569|NCT00003595|Biological|rituximab|
12070570|NCT00003595|Drug|CHOP regimen|
12070571|NCT00003595|Drug|cyclophosphamide|
12070572|NCT00003595|Drug|doxorubicin hydrochloride|
12070573|NCT00003595|Drug|prednisone|
12070574|NCT00003595|Drug|vincristine sulfate|
12070575|NCT00003266|Drug|methylphenidate hydrochloride|
12070576|NCT00003266|Procedure|quality-of-life assessment|
12070577|NCT00003234|Drug|vinorelbine tartrate|
12070578|NCT00003190|Drug|cytarabine|Given IV
12070579|NCT00003190|Drug|daunorubicin hydrochloride|Given IV
12070580|NCT00003190|Drug|etoposide|Given IV
12070581|NCT00003190|Drug|valspodar|Given IV
12070582|NCT00003126|Drug|Interleukin-2|High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
12070583|NCT00071474|Procedure|shamanic healing|
12070584|NCT00071461|Drug|bosentan|"Initial dose: 62.5 mg b.i.d. for 4 weeks.
~Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated).
~body weight < 40 kg (90 lb): 62.5 mg b.i.d."
12070585|NCT00071461|Drug|Placebo|"Initial dose: 62.5 mg b.i.d. for 4 weeks.
~Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated).
~body weight < 40 kg (90 lb): 62.5 mg b.i.d."
12070586|NCT00071448|Drug|insulin human|
12070587|NCT00071448|Drug|insulin lispro|
12070588|NCT00071448|Drug|insulin aspart|
12070589|NCT00071422|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
12070590|NCT00071422|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
12070591|NCT00071422|Drug|placebo|1.5 mL, once daily, self-administered SC injection for 90 days
12070592|NCT00071409|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
12070593|NCT00071409|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
12070594|NCT00071409|Drug|placebo|1.5 mL, once daily, self-administered SC injection for 90 days
12070595|NCT00071396|Drug|Campath-1H|15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.
12070596|NCT00071396|Drug|Rituximab|375 mg/m^2 IV infusion on day 1, then 500 mg/m^2 on days 8, 15, and 22.
12070597|NCT00033527|Drug|INS316|
12070598|NCT00033527|Other|sputum cytology|
12070599|NCT00025350|Drug|gefitinib|
12070600|NCT00003077|Dietary Supplement|omega-3 fatty acid|
12070601|NCT00002935|Drug|porfimer sodium|
12070602|NCT00002723|Drug|suramin|3.192g/square meter total dose given decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65.
12070603|NCT00002723|Drug|suramin|5.320 g/square meter total dose given in decreasing concentrations in 250 cc normal saline via IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65
12070604|NCT00002723|Drug|Suramin|7.661 g/square meter toal dose given in decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,5,58,64,and 65.
12070605|NCT00071331|Drug|Tolvaptan|
12070606|NCT00071292|Behavioral|stress reduction program|
12070607|NCT00071292|Behavioral|meditation|
12070608|NCT00030420|Drug|Celecoxib|400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
12070609|NCT00030420|Drug|Docetaxel|On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
12070610|NCT00026260|Drug|semaxanib|
12070611|NCT00024206|Drug|orantinib|Given orally
12070612|NCT00024206|Other|laboratory biomarker analysis|Correlative studies
12070613|NCT00024206|Other|pharmacological study|Correlative studies
12070614|NCT00024128|Biological|anti-thymocyte globulin|
12070615|NCT00024128|Biological|therapeutic allogeneic lymphocytes|
12070616|NCT00024128|Drug|cyclophosphamide|
12070617|NCT00024128|Drug|cyclosporine|
12070618|NCT00024128|Procedure|peripheral blood stem cell transplantation|
12070619|NCT00024128|Radiation|radiation therapy|
12070620|NCT00023738|Biological|filgrastim|
12070621|NCT00023738|Drug|dacarbazine|
12070622|NCT00023738|Drug|doxorubicin hydrochloride|
12070623|NCT00023738|Drug|ifosfamide|
12070624|NCT00023738|Drug|semaxanib|
12070625|NCT00023738|Procedure|conventional surgery|
12070626|NCT00023738|Radiation|radiation therapy|
12070627|NCT00071279|Drug|SR34006 (idraparinux sodium) Injection|
12070628|NCT00071266|Drug|Niacin Extended Release and Lovastatin Tablets|
12070629|NCT00071253|Drug|Divalproex Sodium (Delayed-Release Tablets)|
12070630|NCT00071253|Drug|Divalproex Sodium (Extended-Release Tablets)|
12070631|NCT00071253|Drug|Olanzapine|
12070632|NCT00071240|Drug|Somatropin (recombinant human growth hormone)|3.0mg sc daily for 6 months, followed by 1.5mg sc daily for 6 months. Dose stopped, held or reduced by study investigators as indicated by adverse events
12070633|NCT00071214|Biological|S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine|
12070634|NCT00071201|Drug|Adefovir Dipivoxil for oral suspension, 2 mg/mL|
12070635|NCT00064428|Drug|fondaparinux - UFH not indicated|2.5mg od, sc (1st dose IV) x 8 days or discharge
12070636|NCT00064428|Other|Control - UFH not indicated|Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
12070637|NCT00064428|Drug|Fondaparinux - UFH indicated|2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion
12070638|NCT00064428|Drug|Control - UFH|UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
12070639|NCT00071227|Drug|Triamcinolone Acetonide (TAC-PF)|
12070640|NCT00071188|Drug|ZD6474|
12070641|NCT00071188|Drug|Paclitaxel|
12070642|NCT00071188|Drug|Carboplatin|
12070643|NCT00071136|Drug|pemetrexed|
12070644|NCT00071136|Drug|gemcitabine|
12070645|NCT00071110|Procedure|Electroacupuncture|For subjects randomized to EA, needles were placed at points GV-20-on the crown of the head and yin tang-on the midline of the forehead roughly at the glabella and treated with electrical stimulation. 30 mm x 0.22 mm sterile stainless steel needles were placed obliquely to a depth of approximately 10 mm and were connected to face-microelectrodes which were connected to the Pantheon Research PENS-Electrostimulator. Electricity was provided at a frequency of 2 Hz and set to a voltage which resulted in the perception of a mild intensity stimulation.
12070646|NCT00071110|Procedure|Sham|For subjects randomized to SA, two needles were placed laterally on the scalp, 3 cuns superior to the temporal attachment of the helix of the ear. This point was selected as it does not correspond to any specific meridian acupuncture point. A disabled electrical cable was connected to the needles and the electrostimulator, with light blinking at 2 Hz but no electrical stimulation provided.
12070647|NCT00071097|Drug|TMC114/rtv|800mg TMC114/100mg rtv once daily
12070648|NCT00071097|Drug|TMC114/rtv|400mg TMC114/100mg rtv both twice daily
12070649|NCT00071097|Drug|TMC114/rtv|400mg TMC114/100mg rtv once daily
12070650|NCT00071097|Drug|TMC114/rtv|600mg TMC114/100mg rtv twice daily
12070651|NCT00071084|Drug|HuMax-CD4|
12070652|NCT00071071|Drug|HuMax-CD4|
12070653|NCT00025467|Drug|thalidomide|Given orally
12070654|NCT00025467|Other|laboratory biomarker analysis|Correlative studies
12070655|NCT00023725|Drug|semaxanib|
12070656|NCT00023725|Procedure|conventional surgery|
12070657|NCT00023725|Radiation|radiation therapy|
12070658|NCT00023699|Drug|gefitinib|
12070659|NCT00022282|Drug|shark cartilage extract AE-941|
12070660|NCT00016250|Drug|MKC-1|
12070661|NCT00015912|Biological|recombinant interferon alfa|Given IV
12070662|NCT00015912|Drug|thalidomide|Given orally
12070663|NCT00015912|Other|laboratory biomarker analysis|Correlative studies
12070664|NCT00015886|Drug|docetaxel|75 milligrams per meter squared intraveneously
12070665|NCT00015886|Drug|fluorouracil|350 milligrams intraveneously
12070666|NCT00014144|Drug|gefitinib|
12070667|NCT00007917|Drug|alvocidib|
12070668|NCT00007917|Drug|gemcitabine hydrochloride|
12070669|NCT00071032|Biological|Liberal (10 g/dL) Transfusion Strategy|This transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization.
12070670|NCT00071032|Biological|Restrictive (Symptomatic) Transfusion Strategy|Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL.
12070671|NCT00071006|Drug|AG-013736 (Axitinib)|patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.
12070672|NCT00070993|Drug|creatine monohydrate|
12070673|NCT00070980|Procedure|Massage therapy|
12070674|NCT00070967|Procedure|Acupuncture|
12070675|NCT00070954|Drug|ginkgo biloba|EgB 761
12070676|NCT00070954|Other|matched placebo|Inactive look-alike placebo
12070677|NCT00070941|Drug|SAM-e|oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.
12070678|NCT00070941|Drug|oral escitalopram|20mg or 30mg daily in two divided doses, along with placebo SAM-e.
12070679|NCT00070941|Drug|placebo|oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.
12070680|NCT00070928|Drug|valerian|
12070681|NCT00070915|Behavioral|Tai chi|
12070682|NCT00070915|Behavioral|Mindfulness-based Stress Reduction program|
12070683|NCT00070915|Procedure|Therapeutic massage|
12070684|NCT00070902|Procedure|Lumbar side-posture spinal adjusting|
12070685|NCT00070837|Drug|MLN2704 (DM1 conjugated monoclonal antibody MLN591)|
12070686|NCT00070824|Procedure|acupuncture|
12070687|NCT00070811|Procedure|Lip revision surgery|Full or partial muscle thickness lip revision surgery.
12070688|NCT00070720|Behavioral|Opinion Leaders, Academic Detailing, Reminders, and Feedback|
12070689|NCT00071058|Drug|XR9576 (Tariquidar)|
12070690|NCT00070733|Drug|testosterone enanthate|
12070691|NCT00070733|Drug|duastride|
12070692|NCT00070707|Drug|Mometasone|Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.
12070693|NCT00070707|Drug|Placebo|Matching placebo nasal spray, administered QD as 2 sprays in each nostril.
12070694|NCT00070707|Drug|Albuterol/Salbutamol|Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
12070695|NCT00070876|Behavioral|Mental health communication skills training|
12070696|NCT00070863|Behavioral|Individual Cognitive Behavioral Therapy|
12070697|NCT00070681|Procedure|Polysomnography|
12070698|NCT00070655|Drug|SR34006 (idraparinux sodium) Injection|
12070699|NCT00070655|Drug|vitamin K antagonist (warfarin or acenocoumarol) tablets|
12070700|NCT00069433|Procedure|Social skills and symptom management training|
12070701|NCT00021099|Drug|ixabepilone|Given IV
12070702|NCT00017368|Biological|filgrastim|
12070703|NCT00017368|Biological|sargramostim|
12070704|NCT00017368|Drug|carboplatin|
12070705|NCT00017368|Drug|cisplatin|
12070706|NCT00017368|Drug|cyclophosphamide|
12070707|NCT00017368|Drug|doxorubicin hydrochloride|
12070708|NCT00017368|Drug|etoposide|
12070709|NCT00017368|Drug|etoposide phosphate|
12070710|NCT00017368|Drug|ifosfamide|
12070711|NCT00017368|Drug|isotretinoin|
12070712|NCT00017368|Drug|melphalan|
12070713|NCT00017368|Drug|thiotepa|
12070714|NCT00017368|Drug|vincristine sulfate|
12070715|NCT00017368|Procedure|conventional surgery|
12070716|NCT00017368|Procedure|peripheral blood stem cell transplantation|
12070717|NCT00017368|Radiation|radiation therapy|
12070718|NCT00003907|Drug|cisplatin|Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
12070719|NCT00003907|Drug|doxorubicin|Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
12070720|NCT00003907|Drug|mitomycin|Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
12070721|NCT00003907|Procedure|embolization|Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.
12070722|NCT00070759|Drug|Daclizumab|
12070723|NCT00070642|Drug|CPG 7909 Injection|CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
12070724|NCT00070642|Drug|dacarbazine|dacarbazine 850mg/m2 in three-week cycles until disease progression
12070725|NCT00070642|Drug|Chemotherapy|"Chemotherapy in three-week cycles until disease progression:
~dacarbazine 850mg/m2"
12070726|NCT00070642|Drug|CPG 7909 Injection|CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
12070727|NCT00070642|Drug|CPG 7909 Injection|CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
12070728|NCT00070629|Drug|CPG 7909|CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.
12070729|NCT00070629|Drug|Chemotherapy|"A taxane and a platinum compound given on week one of three-week cycles:
~Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6"
12070730|NCT00070629|Drug|Chemotherapy|"A taxane and a platinum compound given on week one of three-week cycles:
~Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6"
12070731|NCT00070616|Drug|Palifermin 6 x 60 μg/kg/day|
12070732|NCT00070616|Drug|Palifermin 2 x 180 μg/kg/day|
12070733|NCT00070616|Radiation|radiotherapy|
12070734|NCT00070616|Drug|Chemotherapy|
12070735|NCT00070590|Drug|Bosentan|
12070736|NCT00007839|Drug|beta alethine|
12070737|NCT00006482|Drug|cisplatin|
12070738|NCT00006482|Drug|gemcitabine hydrochloride|
12070739|NCT00006466|Drug|beta alethine|
12070740|NCT00006257|Drug|paclitaxel|
12070741|NCT00006257|Drug|semaxanib|
12070742|NCT00006121|Drug|oxaliplatin|
12070743|NCT00006012|Biological|filgrastim|
12070744|NCT00006012|Drug|amifostine trihydrate|
12070745|NCT00006012|Drug|cisplatin|
12070746|NCT00006012|Drug|etoposide|
12070747|NCT00006012|Drug|paclitaxel|
12070748|NCT00006012|Drug|topotecan hydrochloride|
12070749|NCT00006012|Radiation|radiation therapy|
12070750|NCT00006009|Biological|visilizumab|
12070751|NCT00005998|Drug|carmustine|
12070752|NCT00005998|Drug|cyclophosphamide|
12070753|NCT00005998|Drug|cytarabine|
12070754|NCT00005998|Drug|dexamethasone|
12070755|NCT00005998|Drug|etoposide|
12070756|NCT00005998|Drug|filgrastim|
12070757|NCT00005998|Drug|mitoxantrone hydrochloride|
12070758|NCT00005998|Drug|retrovirus vector LN|
12070759|NCT00005998|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12070760|NCT00005998|Procedure|peripheral blood stem cell transplantation|
12070761|NCT00005998|Procedure|radiation therapy|
12070762|NCT00005800|Biological|Filgrastim|
12070763|NCT00005800|Drug|Docetaxel|
12070764|NCT00005800|Drug|Doxorubicin|
12070765|NCT00005800|Procedure|Surgery|Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection.
12070766|NCT00005794|Drug|perifosine|
12070767|NCT00070694|Drug|MDL100.907|
12070768|NCT00070564|Biological|pegfilgrastim|Given IV
12070769|NCT00070564|Drug|AC regimen|Given IV
12070770|NCT00070564|Drug|cyclophosphamide|Given IV
12070771|NCT00070564|Drug|doxorubicin hydrochloride|Given IV
12070772|NCT00070564|Drug|paclitaxel|Given IV
12070773|NCT00070551|Biological|GTI-2040|Given IV
12070774|NCT00070551|Drug|cytarabine|Given IV
12070775|NCT00070551|Other|pharmacological study|Optional correlative studies
12070776|NCT00070551|Other|laboratory biomarker analysis|Optional correlative studies
12070777|NCT00070538|Drug|cytarabine|
12070779|NCT00070525|Drug|tipifarnib|Given orally
12070780|NCT00070499|Drug|Dasatinib|Given PO
12070781|NCT00070499|Drug|Imatinib Mesylate|Given PO
12070782|NCT00070499|Other|Laboratory Biomarker Analysis|Correlative studies
12070783|NCT00070486|Drug|carboplatin|given IV
12070784|NCT00070486|Drug|celecoxib|given PO
12070785|NCT00070486|Drug|gemcitabine hydrochloride|given IV
12070786|NCT00070486|Drug|zileuton|given PO
12070787|NCT00070473|Drug|pemetrexed disodium|
12070788|NCT00070447|Biological|rituximab|
12070789|NCT00070447|Drug|cyclophosphamide|
12070790|NCT00070447|Drug|doxorubicin hydrochloride|
12070791|NCT00070447|Drug|prednisone|
12070792|NCT00070447|Drug|vincristine sulfate|
12070793|NCT00070447|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12070794|NCT00070434|Drug|capecitabine|825mg/m2 BID, PO, daily
12070795|NCT00070434|Drug|fluorouracil|Bolus + IV for 46 hrs on Day 1
12070796|NCT00070434|Drug|irinotecan hydrochloride|IV infusion over 90 min on Day 1
12070797|NCT00070434|Drug|leucovorin calcium|200mg/m2 IV 2 hour infusion on Day 1
12070798|NCT00070434|Drug|oxaliplatin|85mg/m2 IV infusion for 90minutes on Day 1
12070799|NCT00070434|Radiation|radiation therapy|Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.
12070800|NCT00070434|Drug|Pyridoxine|50mg TID, PO daily
12070801|NCT00070421|Procedure|complementary or alternative medicine procedure|
12070802|NCT00070421|Procedure|management of therapy complications|
12070803|NCT00070421|Procedure|psychosocial assessment and care|
12070804|NCT00070382|Drug|darbepoetin alfa|darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
12070805|NCT00070382|Drug|epoetin alfa|epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period
12070806|NCT00070343|Biological|oblimersen sodium|
12070807|NCT00070343|Drug|dacarbazine|
12070808|NCT00070317|Drug|Isosulfan Blue|Undergo lymphangiography using isosulfan blue or methylene blue
12070809|NCT00070317|Procedure|Lymph Node Mapping|Undergo lymphatic mapping
12070810|NCT00070317|Procedure|Lymphangiography|Undergo lymphangiography using isosulfan blue or methylene blue
12070811|NCT00070317|Drug|Methylene Blue|Undergo lymphangiography using isosulfan blue or methylene blue
12070812|NCT00070317|Procedure|Radionuclide Imaging|Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
12070813|NCT00070317|Procedure|Sentinel Lymph Node Biopsy|Undergo complete pelvic and low para-aortic lymphadenectomy
12070814|NCT00070317|Radiation|Technetium Tc-99m Sulfur Colloid|Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
12070815|NCT00070317|Procedure|Therapeutic Conventional Surgery|Undergo radical hysterectomy
12070816|NCT00070304|Biological|filgrastim|Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL.
12070817|NCT00070304|Drug|gemcitabine hydrochloride|Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8
12070818|NCT00070304|Drug|vinorelbine tartrate|Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8
12070819|NCT00070291|Drug|cyclosporine|Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
12070820|NCT00070278|Drug|cyclophosphamide|
12070821|NCT00070278|Drug|epirubicin hydrochloride|
12070822|NCT00070278|Drug|gemcitabine hydrochloride|
12070823|NCT00070278|Drug|paclitaxel|
12070824|NCT00070278|Genetic|comparative genomic hybridization|
12070825|NCT00070278|Genetic|microarray analysis|
12070826|NCT00070278|Genetic|mutation analysis|
12070827|NCT00070278|Procedure|conventional surgery|
12070828|NCT00070278|Procedure|neoadjuvant therapy|
12070829|NCT00070265|Drug|oxaliplatin|Given IV
12070830|NCT00070265|Drug|capecitabine|Given orally
12070831|NCT00070265|Procedure|therapeutic conventional surgery|Undergo surgical resection
12070832|NCT00070265|Other|laboratory biomarker analysis|Correlative studies
12070833|NCT00070252|Drug|Capecitabine|Given PO
12070834|NCT00070252|Drug|Docetaxel|Given IV
12070835|NCT00070252|Other|Laboratory Biomarker Analysis|Correlative studies
12070836|NCT00070252|Other|Pharmacological Study|Correlative studies
12070837|NCT00070252|Drug|Tipifarnib|Given orally (PO)
12070838|NCT00070239|Drug|alvocidib|Given IV
12070839|NCT00070239|Other|pharmacological study|Correlative studies
12070840|NCT00070239|Radiation|fludeoxyglucose F 18|Correlative studies
12070841|NCT00070239|Other|fluorine F 18 fluorothymidine|Correlative studies
12070842|NCT00070239|Procedure|positron emission tomography|Correlative studies
12070843|NCT00070213|Drug|FOLFOX regimen|
12070844|NCT00070213|Drug|capecitabine|
12070845|NCT00070213|Drug|fluorouracil|
12070846|NCT00070213|Drug|leucovorin calcium|
12070847|NCT00070213|Drug|oxaliplatin|
12070848|NCT00070213|Procedure|quality-of-life assessment|
12070849|NCT00070200|Biological|filgrastim|
12070850|NCT00070200|Drug|cisplatin|
12070851|NCT00070200|Drug|cyclophosphamide|
12070852|NCT00070200|Drug|doxorubicin hydrochloride|
12070853|NCT00070200|Drug|etoposide|
12070854|NCT00070200|Drug|isotretinoin|
12070855|NCT00070200|Drug|melphalan|
12070856|NCT00070200|Drug|topotecan hydrochloride|
12070857|NCT00070200|Drug|vincristine sulfate|
12070858|NCT00070200|Procedure|conventional surgery|
12070859|NCT00070200|Procedure|peripheral blood stem cell transplantation|
12070860|NCT00070200|Radiation|radiation therapy|
12070861|NCT00070187|Biological|aldesleukin|Given IV
12070862|NCT00070187|Biological|filgrastim|Given IV
12070863|NCT00070187|Biological|recombinant interferon gamma|Given IV
12070864|NCT00070187|Drug|carmustine|Given IV
12070865|NCT00070187|Drug|cyclosporine|Given IV
12070866|NCT00070187|Drug|cytarabine|Given IV
12070867|NCT00070187|Drug|etoposide|Given IV
12070868|NCT00070187|Drug|melphalan|Given IV
12070869|NCT00070187|Procedure|autologous bone marrow transplantation|
12070870|NCT00070187|Procedure|bone marrow ablation with stem cell support|
12070871|NCT00070187|Procedure|peripheral blood stem cell transplantation|
12070872|NCT00070174|Drug|asparaginase|
12070873|NCT00070174|Drug|busulfan|
12070874|NCT00070174|Drug|cyclophosphamide|
12070875|NCT00070174|Drug|cyclosporine|
12070876|NCT00070174|Drug|cytarabine|
12070877|NCT00070174|Drug|daunorubicin hydrochloride|
12070878|NCT00070174|Drug|etoposide|
12070879|NCT00070174|Drug|gemtuzumab ozogamicin|
12070880|NCT00070174|Drug|methotrexate|
12070881|NCT00070174|Drug|mitoxantrone hydrochloride|
12070882|NCT00070174|Procedure|allogeneic bone marrow transplantation|
12070883|NCT00070161|Dietary Supplement|EGb761|
12070884|NCT00070161|Drug|donepezil hydrochloride|
12070885|NCT00070161|Procedure|cognitive assessment|
12070886|NCT00070148|Drug|Megestrol Acetate|Megace by mouth for 12 weeks
12070887|NCT00070148|Drug|Oxandrolone 20 mg|20 mg/day for 3 months (12 weeks)
12070888|NCT00070135|Biological|filgrastim|Given SC
12070889|NCT00070135|Biological|Anti-Thymocyte Globulin|Given IV
12070890|NCT00070135|Drug|busulfan|Given IV
12070891|NCT00070135|Drug|fludarabine phosphate|Given IV
12070892|NCT00070135|Drug|methotrexate|Given IV
12070893|NCT00070135|Drug|tacrolimus|Given PO or IV
12070894|NCT00070135|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSC transplantation
12070895|NCT00070122|Drug|oxaliplatin|Given IV
12070896|NCT00070122|Drug|leucovorin calcium|Given IV
12070897|NCT00070122|Drug|capecitabine|Given orally
12070898|NCT00070122|Biological|bevacizumab|Given IV
12070899|NCT00070122|Drug|fluorouracil|Given IV
12070900|NCT00070122|Other|laboratory biomarker analysis|Correlative studies
12070901|NCT00070109|Drug|trabectedin|Given IV
12070902|NCT00070109|Other|pharmacological study|Correlative studies
12070903|NCT00070096|Drug|ixabepilone|
12070904|NCT00070083|Biological|oblimersen sodium|
12070905|NCT00070083|Biological|rituximab|
12070906|NCT00070083|Drug|cyclophosphamide|
12070907|NCT00070083|Drug|doxorubicin hydrochloride|
12070908|NCT00070083|Drug|prednisone|
12070909|NCT00070083|Drug|vincristine sulfate|
12070910|NCT00070070|Biological|BCG vaccine|
12070911|NCT00070070|Biological|NY-ESO-1 peptide vaccine|
12070912|NCT00070070|Biological|sargramostim|
12070913|NCT00070057|Drug|celecoxib|Given orally
12070914|NCT00070057|Procedure|therapeutic conventional surgery|Undergo surgery
12070915|NCT00070057|Other|pharmacological study|Correlative studies
12070916|NCT00070057|Other|laboratory biomarker analysis|Correlative studies
12070917|NCT00070031|Drug|edotecarin|
12070918|NCT00070018|Biological|rituximab|250 mg/m^2, as part of Zevalin regimen
12070919|NCT00070018|Drug|Cyclophosphamide|750 mg/m^2
12070920|NCT00070018|Drug|doxorubicin hydrochloride|50 mg/m^2
12070921|NCT00070018|Drug|prednisone|100 mg
12070922|NCT00070018|Drug|vincristine sulfate|1.4 mg/m^2
12070923|NCT00070018|Radiation|radiation therapy|4000-5000 cGy total
12070924|NCT00070018|Biological|Yttrium-90 ibritumomab tiuxetan|0.4 mCi/kg
12070925|NCT00070018|Biological|Indium-111 ibritumomab tiuxetan|5 mCi
12070926|NCT00070005|Procedure|conventional surgery|
12070927|NCT00070005|Procedure|management of therapy complications|
12070928|NCT00069992|Radiation|Total Body Irradiation|Total body irradiation of 450cGy as a single dose, day -6
12070929|NCT00069992|Drug|Fludarabine|Fludarabine 30mg/m2 Day -5 to -2
12070930|NCT00069992|Drug|Campath 1H|Campath 1H dosing as per institutional SOPs Day -5 to -2
12070931|NCT00069966|Biological|filgrastim|
12070932|NCT00069966|Biological|rituximab|
12070933|NCT00069966|Drug|cisplatin|
12070934|NCT00069966|Drug|cytarabine|
12070935|NCT00069966|Drug|methylprednisolone|
12070936|NCT00069966|Drug|pixantrone dimaleate|
12070937|NCT00069966|Procedure|autologous bone marrow transplantation|
12070938|NCT00069966|Procedure|peripheral blood stem cell transplantation|
12070939|NCT00069953|Biological|filgrastim|During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients >70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42.
12070940|NCT00069953|Biological|pegfilgrastim|During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34.
12070941|NCT00069953|Drug|cisplatin|During induction therapy, patients receive 15 mg/m^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m^2/day by IV over 1 hour beginning on days 57-61.
12070942|NCT00069953|Drug|fluorouracil|During induction therapy, patients receive 650 mg/m^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles.
12070943|NCT00069953|Drug|paclitaxel|During induction therapy, patients receive 200 mg/m^2/day by IV over 2 hours on days 1 and 29.
12070944|NCT00069953|Procedure|conventional surgery|Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.
12070945|NCT00069953|Radiation|radiation therapy|External beam radiotherapy with megavoltage linear accelerators (> 6 MV) will be used to deliver multiple (> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy.
12070946|NCT00069940|Biological|sargramostim|
12070947|NCT00069940|Biological|telomerase: 540-548 peptide vaccine|
12070948|NCT00069927|Drug|Adderall-XR®|Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
12070949|NCT00069927|Drug|Concerta®|Concerta® 18 mg/day for 3-12 weeks depending on subject's response
12070950|NCT00006034|Biological|keyhole limpet hemocyanin|Given intradermally and IV
12070951|NCT00006034|Drug|doxorubicin hydrochloride|Given IV
12070952|NCT00003868|Drug|cyclophosphamide|
12070953|NCT00003868|Drug|methotrexate|
12070954|NCT00003868|Procedure|allogeneic bone marrow transplantation|
12070955|NCT00003868|Procedure|peripheral blood stem cell transplantation|
12070956|NCT00003868|Radiation|iodine I 131 monoclonal antibody BC8|
12070957|NCT00003868|Radiation|radiation therapy|
12070958|NCT00069901|Drug|CT-2103 (poly(L)glutamate-paclitaxel)|
12070959|NCT00069901|Drug|carboplatin|
12070960|NCT00069888|Drug|Docetaxel|
12070961|NCT00069875|Drug|Gemcitabine|
12070962|NCT00069875|Drug|LY293111|
12070963|NCT00069875|Drug|cisplatin|
12070964|NCT00069784|Drug|insulin glargine (HOE901)|Cartridges for use in a pen device, each containing 3 mL of insulin glargine 100 U/mL solution for injection
12070965|NCT00069784|Drug|omega-3 polyunsaturated fatty acids (PUFA)|Gelatin capsules (containing icosapent ethyl esters 465 mg and doconexent ethyl esters 375 mg) for oral administration
12070966|NCT00069784|Drug|placebo|Matching placebo gelatin capsules (containing olive oil) for oral administration
12070967|NCT00069784|Device|reusable pen device for insulin injection|
12070968|NCT00069745|Drug|Satraplatin|
12070969|NCT00069745|Drug|Prednisone|
12070970|NCT00069719|Drug|Glaucoma therapy|
12070971|NCT00069706|Drug|AL-12182 0.003% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12070972|NCT00069706|Other|AL-12182 Ophthalmic Solution Vehicle|Placebo
12070973|NCT00069706|Drug|Latanoprost 0.005% Ophthalmic Solution|Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12070974|NCT00069706|Drug|AL-12182 0.01% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12070975|NCT00069706|Drug|AL-12182 0.03% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
12070976|NCT00069862|Drug|Deferitrin (GT56-252)|
12070977|NCT00069862|Drug|desferoxamine (DFO)|
12070978|NCT00069836|Drug|Rosiglitazone/metformin|
12070979|NCT00069823|Drug|Esomeprazole|Proton pump inhibitor 40 mg orally twice daily
12070980|NCT00069823|Drug|Placebo proton pump inhibitor|Placebo proton pump inhibitor
12070981|NCT00069732|Behavioral|qigong|
12070982|NCT00069732|Behavioral|acupressure-TAT|
12070983|NCT00069849|Drug|ABT-089|
12070984|NCT00069758|Drug|SDX-105|
12070985|NCT00069641|Biological|Iduronate-2-sulfatase enzyme replacement therapy|Patients will receive weekly infusions of idursulfase at a dose of 0.5 mg/kg.
12070986|NCT00069641|Biological|iduronate-2-sulfatase enzyme replacement therapy|Patients will receive every other week infusions of idursulfase at a dose of 0.5 mg/kg.
12070987|NCT00069641|Biological|Placebo|Patients will receive weekly infusions of placebo.
12070988|NCT00069524|Drug|oyster mushroom|
12070989|NCT00005630|Biological|ras peptide cancer vaccine|
12070990|NCT00005630|Biological|sargramostim|
12070991|NCT00005629|Biological|AFP gene hepatocellular carcinoma vaccine|"Patients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides emulsified in 2 ml of Montanide ISA-51.
~Group A AFP peptide dose 100 ug Group B AFP peptide dose 500 ug Group C AFP peptide dose 1000 ug"
12070992|NCT00004922|Drug|irinotecan hydrochloride|
12070993|NCT00004886|Drug|docetaxel|
12070994|NCT00004886|Drug|dofequidar fumarate|
12070995|NCT00069654|Procedure|Forearm blood flow study|
12070996|NCT00069654|Procedure|Brachial artery reactivity study|
12070997|NCT00069654|Procedure|Treadmill exercise test|
12070998|NCT00069628|Device|GlucoWatch® G2™ Biographer (GW2B)|
12070999|NCT00069628|Device|Continuous Glucose Monitoring System (CGMS)|
12071000|NCT00069615|Device|GlucoWatch® G2™ Biographer (GW2B)|
12071001|NCT00069615|Device|Continuous Glucose Monitoring System™ (CGMS)|
12071002|NCT00069602|Device|Continuous Glucose Monitoring System (CGMS)|
12071003|NCT00069602|Device|GlucoWatch G2TM Biographer (GW2B)|
12071004|NCT00069576|Behavioral|nutritional counseling|
12071005|NCT00069576|Behavioral|self blood glucose monitoring|
12071006|NCT00069563|Behavioral|Reaching Educators, Children, and Parents (RECAP)|
12071007|NCT00069550|Drug|dextromethorphan|
12071008|NCT00069550|Drug|donepezil hydrochloride|
12071009|NCT00069537|Device|The GlucoWatch® G2™ Biographer (GW2B)|
12071010|NCT00069537|Device|The Continuous Glucose Monitoring System (CGMS™)|
12071011|NCT00069511|Drug|UT-231B|
12071012|NCT00069498|Drug|5-aminosalicylic acid|
12071013|NCT00004883|Biological|trastuzumab|Given IV
12071014|NCT00004883|Other|laboratory biomarker analysis|Correlative studies
12071015|NCT00004856|Biological|trastuzumab|Given IV
12071016|NCT00003930|Drug|cisplatin|
12071017|NCT00003930|Drug|gemcitabine hydrochloride|
12071018|NCT00003930|Drug|paclitaxel|
12071019|NCT00003930|Procedure|conventional surgery|
12071020|NCT00003930|Radiation|radiation therapy|
12071021|NCT00003832|Drug|bromodeoxyuridine|Given IV
12071022|NCT00003832|Procedure|conventional surgery|Undergo surgery
12071023|NCT00003832|Other|laboratory biomarker analysis|Correlative studies
12071315|NCT00005845|Drug|tipifarnib|Given PO
12071024|NCT00069459|Drug|Extended-release Bupropion Hydrochloride|Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride
12071025|NCT00069446|Drug|rhuMAb VEGF (telbermin)|
12071026|NCT00069420|Behavioral|Cognitive Motivational Behavior Therapy|
12071027|NCT00069407|Procedure|Electroconvulsive Therapy|Electroconvulsive therapy
12071028|NCT00069381|Behavioral|Psychotherapy treatment|
12071029|NCT00003827|Drug|amifostine trihydrate|
12071030|NCT00003827|Drug|cytarabine|
12071031|NCT00003827|Drug|topotecan hydrochloride|
12071032|NCT00003620|Drug|alvocidib|Given IV
12071033|NCT00003620|Other|laboratory biomarker analysis|Correlative studies
12071034|NCT00003594|Drug|irinotecan|
12071035|NCT00003594|Drug|fluorouracil|
12071036|NCT00003594|Drug|leucovorin calcium|
12071037|NCT00003594|Drug|oxaliplatin|
12071038|NCT00003540|Drug|gemcitabine hydrochloride|
12071039|NCT00003463|Drug|carmustine|
12071040|NCT00003463|Drug|irinotecan hydrochloride|
12071041|NCT00003463|Drug|polifeprosan 20 with carmustine implant|
12071042|NCT00003463|Procedure|surgical procedure|
12071043|NCT00069355|Drug|Propranolol|
12071044|NCT00069277|Drug|E7389|
12071045|NCT00069264|Drug|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
12071046|NCT00069251|Drug|Bupropion|
12071047|NCT00003449|Drug|dexamethasone|
12071048|NCT00003449|Drug|gemcitabine hydrochloride|
12071049|NCT00003449|Drug|paclitaxel|
12071050|NCT00003281|Drug|paclitaxel|
12071051|NCT00003281|Drug|topotecan hydrochloride|
12071052|NCT00003281|Radiation|radiation therapy|
12071053|NCT00003280|Biological|rituximab|
12071054|NCT00003245|Drug|irinotecan hydrochloride|
12071055|NCT00003113|Biological|filgrastim|Filgrastim (granulocyte colony-stimulating factor; G-CSF) is given subcutaneously on days 5-21 and 33-42 of each cycle.
12071056|NCT00003113|Drug|cyclophosphamide|Cyclophosphamide are given on days 22-31 of each cycle.
12071057|NCT00003113|Drug|etoposide|Etoposide is given on days 1-3.
12071058|NCT00003113|Drug|lomustine|Lomustine is given on day 1 of cycles 1 and 3 only.
12071059|NCT00003113|Drug|procarbazine hydrochloride|Procarbazine are given on days 22-31 of each cycle.
12071060|NCT00003113|Radiation|radiation therapy|Following the third cycle of chemotherapy, if residual disease is confined to 1 or 2 nodal sites, patients receive radiation therapy.
12071061|NCT00069329|Drug|anakinra|daily injection of subcutaneous injection
12071062|NCT00069316|Drug|Omr-IgG-am|
12071063|NCT00069186|Drug|Creatine Monohydrate|
12071064|NCT00069238|Biological|Alemtuzumab (Campath)|Alemtuzumab (Campath) followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) every 3 weeks for up to 6 cycles.
12071065|NCT00069238|Drug|EPOCH|Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) + Alemtuzumab (Campath) every 3 weeks for up to 6 cycles.
12071066|NCT00069121|Drug|Capecitabine|1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.
12071067|NCT00069121|Drug|Oxaliplatin|130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
12071068|NCT00069121|Drug|Leucovorin (LV)|Administered by one of two regimens, as specified in the arm description.
12071069|NCT00069121|Drug|5-Fluorouracil (5-FU)|Administered by one of two regimens, as specified in the arm description.
12071070|NCT00069108|Drug|5 FU|As prescribed, in 2 week cycles
12071071|NCT00069108|Drug|Leucovorin|As prescribed, in 2 week cycles
12071072|NCT00069108|Drug|Oxaliplatin|As prescribed, in 3 week cycles
12071073|NCT00069108|Drug|Oxaliplatin|As prescribed, in 2 week cycles
12071074|NCT00069108|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-15 of each 3 week cycle
12071075|NCT00069095|Drug|Oxaliplatin 130 mg/m^2|Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
12071076|NCT00069095|Drug|Capecitabine 1000 mg/m^2|Capecitabine was taken within 30 min after the end of breakfast and dinner.
12071077|NCT00069095|Drug|Bevacizumab 7.5 mg/kg|Bevacizumab was administered in a 30 to 90 min infusion.
12071078|NCT00069095|Drug|Placebo for bevacizumab 7.5 mg/kg|Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
12071079|NCT00069095|Drug|Oxaliplatin 85 mg/m^2|Oxaliplatin 85 mg/m^2 was administered simultaneously with leucovorin in a 2 h infusion.
12071080|NCT00069095|Drug|Leucovorin 200 mg/m^2|Leucovorin was administered simultaneously with oxaliplatin 85 mg/m^2 in a 2 h infusion.
12071081|NCT00069095|Drug|Fluorouracil 400 mg/m^2|
12071082|NCT00069095|Drug|Bevacizumab 5 mg/kg|Bevacizumab was administered in a 30 to 90 min infusion.
12071083|NCT00069095|Drug|Placebo for bevacizumab 5 mg/kg|Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
12071084|NCT00002638|Biological|filgrastim|
12071085|NCT00002638|Biological|sargramostim|
12071086|NCT00002638|Drug|carmustine|
12071087|NCT00002638|Drug|cyclophosphamide|
12071088|NCT00002638|Drug|cytarabine|
12071089|NCT00002638|Drug|etoposide|
12071090|NCT00002638|Procedure|peripheral blood stem cell transplantation|
12071091|NCT00002638|Radiation|radiation therapy|
12071092|NCT00002559|Biological|filgrastim|
12071093|NCT00002559|Drug|cisplatin|
12071094|NCT00002559|Drug|ifosfamide|
12071095|NCT00002559|Drug|paclitaxel|
12071096|NCT00002533|Drug|fluconazole|
12071097|NCT00002533|Radiation|radiation therapy|
12071098|NCT00069173|Behavioral|Project FAB (Fitness and Bone)|
12071099|NCT00069134|Dietary Supplement|sulfur amino acids|Sixteen (16) children with edematous SCU will be randomly assigned to either a supplement of SAA or an isonitrogenous amount of alanine
12071316|NCT00005845|Other|laboratory biomarker analysis|Correlative studies
12071100|NCT00069017|Biological|MEDI-522|MEDI-522 is formulated in a sterile isotonic solution of 10 mM histidine-HCl at pH 6 containing 100 mg of MEDI-522 protein at a concentration of 100 mg/mL.
12071101|NCT00069017|Other|Placebo|Placebo for MEDI-522 contains 10 mM histidine-HCl at pH 6, 0.1% Tween-80, 1.5% Mannitol, 4.3 µg/mL Vitamin B12, and 2 µg/mL D&C Yellow #10.
12071102|NCT00030381|Drug|4'-iodo-4'-deoxydoxorubicin|Given IV
12071103|NCT00030381|Other|pharmacological study|Correlative studies
12071104|NCT00026286|Drug|conjugated estrogens|
12071105|NCT00026286|Drug|medroxyprogesterone|
12071106|NCT00025116|Drug|gefitinib|
12071107|NCT00069160|Drug|docetaxel|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8.
12071108|NCT00069160|Drug|tariquidar|Patients receive tariquidar intravenous (IV) over 30 minutes on days 8 and 22.
12071109|NCT00069160|Other|99mTc-sestamibi imaging|Bolus injection of 29 mCi of 99mTc-sestamibi intravenously for each imaging study.
12071110|NCT00069082|Drug|Civamide (Zucapsaicin)|Nasal Solution 0.01%
12071111|NCT00069082|Drug|Sodium Chloride|Nasal Solution 10%
12071112|NCT00069030|Biological|VRC-HIVDNA009-00-VP (Gag-Pol-Nef-multiclade-Env) with adjuvant VRC-ADJDNA004-IL2-VP|
12071113|NCT00068991|Behavioral|HIV skills training program and questionnaire|Two-hour weekly skills training sessions followed by evaluation questionnaire
12071114|NCT00068991|Behavioral|Community-level stigma reduction program|Two-hour training sessions focusing on anti-stigma and anti-discrimination
12071115|NCT00068991|Behavioral|Cross-sectional survey|Survey evaluation of community attitudes towards HIV
12071116|NCT00068952|Drug|Edotecarin|
12071117|NCT00068952|Drug|Temozolomide|
12071118|NCT00068952|Drug|Carmustine (BCNU)|
12071119|NCT00068952|Drug|Lomustine (CCNU)|
12071120|NCT00069069|Drug|Intransal instillation of E-selectin|Intranasal recombinant human E-selectin
12071121|NCT00069056|Procedure|Laser Treatment|
12071122|NCT00068913|Drug|Dichloroacetate|
12071123|NCT00068874|Behavioral|Coping skills and cognitive restructuring techniques|This is a cognitive psychoeducational program designed to enhance coping and adaptation to SLE. Participants will attend five study visits over 5 months. The first three visits are biweekly, 45-minute sessions during which the adolescent will be taught coping skills and cognitive restructuring techniques. The coping skills training will include training in relaxation, distraction, and problem-solving skills. The cognitive restructuring techniques will assist adolescents in using more accurate and adaptive cognitive responses.
12071124|NCT00068874|Behavioral|Educational training|Participants will attend five study visits that will include disease-appropriate education materials.
12071125|NCT00068861|Drug|metformin XR|
12071126|NCT00068861|Drug|clomiphene citrate|
12071127|NCT00068848|Behavioral|Quick start oral contraceptive initiation|
12071128|NCT00068835|Behavioral|Lindamood-Bell training for dyslexia|
12071129|NCT00068822|Device|Percutaneous vertebroplasty|Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture
12071130|NCT00068822|Procedure|Sham vertebroplasty|Participants, following local anesthesia with lidocaine and bupivacaine, were given verbal and physical cues such as pressure on the back, but the needle was not placed.
12071131|NCT00068809|Procedure|Short Cycle Antiretroviral Therapy|
12071132|NCT00068783|Drug|imatinib mesylate|Given orally
12071133|NCT00068783|Other|laboratory biomarker analysis|Correlative studies
12071134|NCT00068770|Radiation|radiation therapy|Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment
12071135|NCT00068770|Drug|Celecoxib|Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2 doses will be administered at least 12 hours apart. Celecoxib will continue throughout the 6 week course of RT.
12071136|NCT00068757|Biological|trastuzumab|
12071137|NCT00068757|Drug|lonafarnib|
12071138|NCT00068757|Drug|paclitaxel|
12071139|NCT00068757|Other|pharmacological study|
12071140|NCT00068744|Drug|cisplatin|
12071141|NCT00068744|Drug|fluorouracil|
12071142|NCT00068744|Drug|mitomycin C|
12071143|NCT00068744|Radiation|radiation therapy|
12071144|NCT00068731|Dietary Supplement|lycopene|
12071145|NCT00068718|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
12071146|NCT00068692|Radiation|Radiotherapy|Undergo external beam radiation therapy
12071147|NCT00068692|Drug|Fluorouracil|Given IV
12071148|NCT00068692|Drug|Leucovorin Calcium|Given IV
12071149|NCT00068692|Drug|Oxaliplatin|Given IV
12071150|NCT00068692|Drug|Irinotecan|Given IV
12071151|NCT00068666|Drug|temozolomide|
12071152|NCT00068666|Radiation|radiation therapy|
12071153|NCT00068653|Drug|Celecoxib|Celecoxib 400mg orally two times a day, taken with meals.
12071154|NCT00068653|Drug|ZD1839|ZD1839 250 mg po every day, taken with or without food.
12071155|NCT00068614|Biological|HER-2/neu peptide vaccine|
12071156|NCT00068601|Drug|cyclophosphamide|Part of planned chemotherapy regimen
12071157|NCT00068601|Drug|goserelin acetate|Given subcutaneously
12071158|NCT00068588|Biological|GTI-2040|Given IV
12071159|NCT00068588|Drug|capecitabine|Given orally
12071160|NCT00068575|Biological|Recombinant Interferon Alfa|3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses.
12071161|NCT00068575|Drug|Cisplatin|30 mg/m^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy.
12071162|NCT00068575|Drug|Fluorouracil|175 mg/m^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168.
12071163|NCT00068575|Radiation|Radiation Therapy|External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.
12071164|NCT00068549|Drug|Gemcitabine Hydrochloride|Given IV
12071165|NCT00068549|Drug|Cisplatin|Given IV
12071166|NCT00068549|Radiation|Radiation Therapy|Undergo whole pelvis radiotherapy
12071167|NCT00068549|Radiation|Internal Radiation Therapy|Undergo brachytherapy
12071375|NCT00004125|Drug|docetaxel|
12071168|NCT00068523|Biological|anti-thymocyte globulin|anti-thymocyte globulin IV over 4 hours on days -2 to -1
12071169|NCT00068523|Drug|cyclophosphamide|cyclophosphamide IV over 1 hour on days -3 to -2
12071170|NCT00068523|Drug|cyclosporine|oral cyclosporine on days -1 to 100
12071171|NCT00068523|Drug|fludarabine phosphate|fludarabine IV over 30 minutes on days -8 to -4
12071172|NCT00068523|Drug|methylprednisolone|methylprednisolone (oral or IV) on days 5-15
12071173|NCT00068523|Procedure|UV light therapy|Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days. Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4.
12071174|NCT00068523|Procedure|allogeneic bone marrow transplantation|
12071175|NCT00068523|Procedure|peripheral blood stem cell transplantation|Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.
12071176|NCT00068510|Biological|therapeutic autologous dendritic cells|
12071177|NCT00068497|Drug|gefitinib|Given orally
12071178|NCT00068484|Drug|topotecan hydrochloride|Given IV
12071179|NCT00068484|Drug|bortezomib|Given IV
12071180|NCT00068484|Other|pharmacological study|Correlative studies
12071181|NCT00068484|Other|laboratory biomarker analysis|Correlative studies
12071182|NCT00068471|Drug|anidulafungin|
12071183|NCT00068458|Dietary Supplement|Calcium-Rich Diet|1,200 - 2,500 mg/day. 6 month intervention
12071184|NCT00068458|Other|Arm 2: Exercise + Calcium-Rich Diet|Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.
12071185|NCT00068458|Other|Exercise + Fruit & Vegetable, Low Fat + Calcium Diet|1,200 - 2,500 Calcium intake per day. 6 month intervention period.
12071186|NCT00068445|Drug|lamotrigine|
12071187|NCT00068445|Other|Placebo|
12071188|NCT00068432|Drug|Celecoxib|Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
12071189|NCT00068432|Drug|Gemcitabine Hydrochloride|Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
12071190|NCT00068419|Drug|tamoxifen citrate|Given orally
12071191|NCT00068419|Drug|sulindac|Given orally
12071192|NCT00068419|Other|laboratory biomarker analysis|Correlative studies
12071193|NCT00068406|Radiation|3-Dimensional Conformal Radiation Therapy|
12071194|NCT00068406|Drug|Cisplatin|Given IV
12071195|NCT00068406|Procedure|Conventional Surgery|
12071196|NCT00068393|Drug|Doxorubicin|Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.
12071197|NCT00068393|Drug|Gemcitabine|Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.
12071198|NCT00068393|Drug|G-CSF (granulocyte-colony stimulating factor)|Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.
12071199|NCT00068393|Drug|Neulasta|Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.
12071200|NCT00068380|Drug|imatinib mesylate|Given orally
12071201|NCT00068380|Other|laboratory biomarker analysis|Correlative studies
12071202|NCT00068367|Drug|erlotinib hydrochloride|150 mg per day, daily until disease progression
12071203|NCT00068341|Biological|trastuzumab|Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
12071204|NCT00068341|Drug|carboplatin|Cycle 1-8 Day 1 or 2 AUC = 6 IV
12071205|NCT00068341|Drug|docetaxel|Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
12071206|NCT00068341|Biological|trastuzumab|"Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
12071207|NCT00068328|Procedure|psychosocial assessment and care|
12071208|NCT00068328|Procedure|quality-of-life assessment|
12071209|NCT00068315|Drug|bortezomib|Given IV
12071210|NCT00068315|Drug|fludarabine phosphate|Given IV
12071211|NCT00068315|Biological|rituximab|Given IV
12071212|NCT00068302|Drug|sirolimus|3-6 subjects will be enrolled into each dose level
12071213|NCT00068289|Drug|bortezomib|
12071214|NCT00068276|Dietary Supplement|cholecalciferol|
12071215|NCT00068263|Radiation|radiation therapy|
12071216|NCT00068250|Drug|rituximab|375 mg/m2, intravenously three days prior to the first cycle of methotrexate
12071217|NCT00068250|Drug|methotrexate|Five cycles of methotrexate (MTX) at 3.5 gm/m2 administered every two weeks on weeks 1, 3, 5, 7, and 9 via intravenous infusion over four hours once per cycle. Calcium leucovorin 25 mg orally or intravenously every six hours initiated exactly 24 hours following the start of the MTX infusion. Methotrexate levels to be monitored daily, and calcium leucovorin discontinued when the MTX level is less than 10 micromolar.
12071218|NCT00068250|Drug|temozolomide 100 mg/m^2|Temozolomide 100 mg/m^2 by mouth per day for five days on weeks 4 and 8.
12071219|NCT00068250|Drug|temozolomide 150 mg/m^2|Temozolomide 150 mg/m^2 by mouth per day for five days on weeks 4 and 8.
12071220|NCT00068250|Drug|temozolomide 200 mg/m^2|Temozolomide 200 mg/m^2 per day by mouth for five days on weeks 4 and 8.
12071221|NCT00068250|Radiation|radiation therapy|Whole brain irradiation (WBRT) during weeks 11, 12, and 13, five days per week (excluding weekends). A daily dose of 2.4 Gy delivered in two fractions of 1.2 Gy each with a minimum inter-fraction interval of 6 hours, with a total dose to brain and meninges of 36 Gy.
12071222|NCT00068250|Drug|post-radiation therapy temozolomide|Temozolomide (TMZ) 200 mg/m^2 by mouth per day for 5 days on weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 for a total of 10 cycles.
12071223|NCT00068237|Procedure|salivary gland transfer|Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1
12071224|NCT00068237|Radiation|Post-operative radiation therapy|Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.
12071225|NCT00068211|Drug|ILX651|
12071226|NCT00068198|Biological|Dryvax|
12071227|NCT00068185|Drug|Black cohosh|
12071228|NCT00068172|Drug|PI-88|
12071229|NCT00068133|Genetic|Plasmid based Gene Transfer product-VLTS-589|
12071230|NCT00025207|Drug|gefitinib|Given orally
12071231|NCT00025207|Other|laboratory biomarker analysis|Correlative studies
12071232|NCT00021268|Drug|tocladesine|
12071233|NCT00020904|Drug|ixabepilone|
12071234|NCT00068094|Drug|Probiotic-containing powder|
12071235|NCT00068081|Drug|Capsaicin Dermal Patch|
12071236|NCT00017043|Drug|ixabepilone|
12071237|NCT00016939|Drug|alvocidib|
12071238|NCT00016874|Drug|cisplatin|
12071239|NCT00016874|Drug|paclitaxel|
12071240|NCT00016874|Drug|triapine|
12071241|NCT00016341|Biological|filgrastim|
12071242|NCT00016341|Drug|cisplatin|
12071243|NCT00016341|Drug|doxorubicin hydrochloride|
12071244|NCT00016341|Drug|megestrol acetate|
12071245|NCT00016341|Drug|paclitaxel|
12071246|NCT00016341|Drug|tamoxifen citrate|
12071247|NCT00068107|Drug|Replagal|enzyme replacement therapy
12071248|NCT00068068|Drug|Talaporfin sodium (LS11)|
12071249|NCT00068068|Device|LED-based light infusion device|
12071250|NCT00068068|Device|Light emitting diodes (LED)|
12071251|NCT00068068|Procedure|Photodynamic therapy|
12071252|NCT00068068|Procedure|Phototherapy|
12071253|NCT00068068|Procedure|Chemotherapy|
12071254|NCT00068055|Drug|Omr-lgG-am|Omr-IgG-am™ 5% is provided in 100 ml bottles (5.0 grams) as a sterile solution containing 5% protein, 10% maltose and water for injection. This product is licensed in Israel, but not in the US.
12071255|NCT00068055|Drug|Polygam® S/D|Polygam® S/D is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. When reconstituted (5%) with the supplied diluent (sterile water for injection, USP) Polygam® S/D contains approximately 50mg of protein per ml (approximately 90% is gamma globulin); 3mg/ml human albumin, 22.5 mg/ml glycine, 20 mg/ml glucose, 2mlg/ml polyethylene glycol (PEG), 1 mcg/ml tri-nbutyl phosphate, 1 mcg/ml octoxynol 9, and 100 mcg/ml polysorbate 80.
12071256|NCT00068055|Drug|Placebo|Normal Saline.
12071257|NCT00068042|Drug|Pegvisomant|
12071258|NCT00068042|Drug|Sandostatin LAR|
12071259|NCT00067899|Drug|Vitamin E with and without Vitamin C|
12071260|NCT00068029|Drug|Pegvisomant/ Sandostatin LAR|
12071261|NCT00068029|Drug|Sandostatin LAR|
12071262|NCT00068029|Drug|Pegvisomant|
12071263|NCT00067990|Drug|Losartan 100mg|To be started within three months of transplant and continued for five years.
12071264|NCT00067990|Drug|Placebo|No treatment with continued follow-up for five years.
12071265|NCT00067964|Behavioral|small changes in physical activity and diet|
12071266|NCT00067951|Drug|rosiglitazone/metformin|
12071267|NCT00067938|Drug|lamotrigine|Lamotrigine
12071268|NCT00067925|Behavioral|Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program|
12071269|NCT00016276|Drug|dexrazoxane hydrochloride|Given IV
12071270|NCT00016276|Drug|doxorubicin hydrochloride|Given IV
12071271|NCT00016276|Drug|cyclophosphamide|Given IV
12071272|NCT00016276|Drug|paclitaxel|Given IV
12071273|NCT00016276|Biological|trastuzumab|Given IV
12071274|NCT00016276|Procedure|therapeutic conventional surgery|Undergo breast conservation surgery, modified radical mastectomy, or mastectomy
12071275|NCT00016276|Radiation|radiation therapy|Undergo radiation therapy
12071276|NCT00016276|Drug|tamoxifen citrate|Given orally
12071277|NCT00016276|Other|laboratory biomarker analysis|Correlative studies
12071278|NCT00010036|Drug|carboplatin|
12071279|NCT00010036|Drug|irinotecan hydrochloride|
12071280|NCT00010036|Radiation|radiation therapy|
12071281|NCT00008359|Drug|caspofungin acetate|
12071282|NCT00008359|Drug|liposomal amphotericin B|
12071283|NCT00008086|Dietary Supplement|calcitriol|
12071284|NCT00008086|Drug|carboplatin|
12071285|NCT00006346|Procedure|psychosocial assessment and care|
12071286|NCT00006346|Procedure|quality-of-life assessment|
12071287|NCT00067912|Drug|Duloxetine Hydrochloride|
12071288|NCT00067912|Drug|Venlafaxine Extended Release|
12071289|NCT00006265|Drug|ara-C|3 g/sq m IV infusion over 3 hours Days 1-5
12071290|NCT00006265|Biological|gemtuzumab ozogamicin|9 mg/sq m IV infusion over 2 hrs D 1 (Cohort I); D 7 (Cohorts II, IA, & IV); & D 14 (Cohort IV) 4.5 mg/sq m IV infusion over 2 hrs D 8 (Cohort I) & D 14 (Cohort II)
12071291|NCT00006254|Biological|salmonella VNP20009|
12071292|NCT00006223|Biological|recombinant flt3 ligand|
12071293|NCT00006103|Drug|fluorouracil|
12071294|NCT00006103|Drug|irinotecan hydrochloride|
12071295|NCT00006103|Drug|leucovorin calcium|
12071296|NCT00006096|Drug|cisplatin|
12071297|NCT00006096|Radiation|radiation therapy|
12071298|NCT00067873|Behavioral|Diet|
12071299|NCT00067873|Behavioral|Aerobic exercise|
12071300|NCT00067873|Behavioral|Resistance exercise|
12071301|NCT00067860|Drug|recombinant human growth hormone|
12071302|NCT00067860|Behavioral|diet modification|
12071303|NCT00067847|Behavioral|State-directed nutrition policy change|
12071304|NCT00067834|Device|Pulsing electromagnetic field (PEMF)|
12071305|NCT00006019|Drug|azacitidine|
12071306|NCT00006019|Drug|sodium phenylbutyrate|
12071307|NCT00006002|Drug|dexamethasone|
12071308|NCT00006002|Drug|semaxanib|
12071309|NCT00005887|Drug|efaproxiral|
12071310|NCT00005887|Radiation|radiation therapy|
12071311|NCT00005886|Drug|arzoxifene hydrochloride|
12071312|NCT00005886|Drug|tamoxifen citrate|
12071313|NCT00005857|Biological|trastuzumab|
12071314|NCT00005857|Drug|docetaxel|
12071317|NCT00005845|Other|pharmacological study|Correlative studies
12071318|NCT00067808|Drug|Decitabine|10 mg/m^2 by vein over 1 hour daily for 10 days
12071319|NCT00067808|Drug|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days
12071320|NCT00067808|Drug|Decitabine|20 mg/m2 subcutaneous (SQ) daily x 5 days
12071321|NCT00067782|Drug|Atazanavir (immediate switch)|Capsules, Oral, 400mg, Once daily, 48 weeks.
12071322|NCT00067782|Drug|Atazanavir (Week 24 switch)|Capsules, Oral, 400mg, Once daily, 48 weeks.
12071323|NCT00067769|Behavioral|Internet-based intervention UCanPoopToo|Internet-based intervention to administer Enhanced Toilet Training (ETT).
12071324|NCT00067769|Behavioral|treatment as usual|Routine clinical care.
12071325|NCT00005804|Drug|cyclophosphamide|
12071326|NCT00005804|Procedure|allogeneic bone marrow transplantation|
12071327|NCT00005804|Radiation|radiation therapy|
12071328|NCT00005090|Biological|bleomycin sulfate|10 U/m^2 given on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
12071329|NCT00005090|Drug|carmustine|150/m^2 on days -6 to -4 (4-6 days before transplant).
12071330|NCT00005090|Drug|cyclophosphamide|100 mg/kg on day -2 (2 days before transplant).
12071331|NCT00005090|Drug|dacarbazine|375 mg/m^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
12071332|NCT00005090|Drug|doxorubicin hydrochloride|25 mg/m^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
12071333|NCT00005090|Drug|etoposide|60 mg/kg on day -4 (4 days before transplant).
12071334|NCT00005090|Drug|vinblastine|6 mg/m^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
12071335|NCT00005090|Procedure|peripheral blood stem cell transplantation|2 x 10^6 CD34+ blood mononuclear cells/kg of actual body weight
12071336|NCT00067756|Drug|4-PBA|During the first 3 days of this phase baseline serum AAT levels will be determined. The participants will be then given increased amounts of 4-PBA orally in 6 divided doses (day 4-6, 30 g/day and day 7-9, 40/day
12071337|NCT00067743|Drug|Lenalidomide|supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day
12071338|NCT00067730|Drug|Drotrecogin Alfa (activated)|
12071339|NCT00067717|Behavioral|Distance healing|
12071340|NCT00067704|Behavioral|Trauma writing|
12071341|NCT00067704|Behavioral|Writing about daily events|
12071342|NCT00067691|Procedure|Acupuncture|
12071343|NCT00067678|Drug|soy protein|
12071344|NCT00067665|Other|Ultrafiltration|All patients participating in the trial require evaluation of dry-weight at each dialysis visit for evaluation. An initial weight loss of 0.1kg/10 kg body-weight will be prescribed per dialysis. If ultrafiltration is not tolerated based on muscle cramps, need for excessive saline or symptomatic hypotension, the intensity of ultrafiltration will be reduced by 50%. If ultrafiltration is still not tolerated, the weight loss will be further reduced by 50%. If the patient cannot tolerate at least 0.2 kg incremental weight loss per dialysis, the patient will be said to be at goal dry-weight. Thus, by this protocol, all patients must experience symptoms of volume depletion to be at dry weight.
12071345|NCT00067652|Behavioral|Education and awareness about body image issues.|
12071346|NCT00067639|Drug|Pegfilgrastim (Neulasta)|12 mg single injection of pegfilgrastim under the skin prior to apheresis.
12071347|NCT00067639|Procedure|Apheresis|Collection of stem cells, repeated daily until target stem cell dose reached, maximum of 5 procedures.
12071348|NCT00067626|Dietary Supplement|Chromium|500/1000 mcg oral chromium picolinate taken daily or placebo (crossover)
12071349|NCT00067613|Other|Benchmarking Management Practices|"The Benchmarking intervention included:
~Data feedback: Using existing data from the NRN Generic Database and Key Care Practices Survey at their NICU to collect data on the perceptions of care.
~Training in Continuous Quality Improvement (CQI) Techniques
~Review of best existing evidence
~Site visits to the Centers with the Lowest Rates of BPD
~Selection of Practices to change: Each site team selected practices for modification at their own center"
12071350|NCT00067613|Other|Standard Management Practices|Centers assigned to the control group continued to receive routine information on their own center's outcomes, and all information routinely supplied within the NRN. Control centers did not participate in organized discussions of the interventions applied within the Benchmarking centers. At the completion of the study, Control Centers were offered a workshop on the Benchmarking techniques.
12071351|NCT00067600|Behavioral|Diet with increased fruits, vegetables, and calcium|
12071352|NCT00067600|Behavioral|Increased high impact activity and resistance training|
12071353|NCT00067574|Behavioral|Structured treatment interruption|
12071354|NCT00067561|Drug|Alosetron|
12071355|NCT00067548|Drug|EKB-569|
12071356|NCT00067535|Drug|Cocaine-Related Disorders|
12071357|NCT00067522|Behavioral|User-independent contraception program|
12071358|NCT00067522|Behavioral|Future Planning Perspectives program|
12071359|NCT00067509|Drug|emergency contraception (estrogen/progesterone)|
12071360|NCT00067470|Drug|Placebo|
12071361|NCT00067470|Drug|N-acetylgalactosamine 4-sulfatase|
12071362|NCT00004256|Biological|sargramostim|
12071363|NCT00004256|Procedure|quality-of-life assessment|
12071364|NCT00004256|Radiation|radiation therapy|
12071365|NCT00004233|Drug|fluorouracil|
12071366|NCT00004233|Drug|leucovorin calcium|
12071367|NCT00004233|Drug|triacetyluridine|
12071368|NCT00004221|Drug|Carboplatin|Given IV
12071369|NCT00004221|Drug|Cyclophosphamide|Given IV
12071370|NCT00004221|Biological|Filgrastim|Given SQ
12071371|NCT00004221|Drug|Paclitaxel|Given IV
12071372|NCT00004221|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplantation
12071373|NCT00004221|Drug|Topotecan Hydrochloride|Given IV
12071374|NCT00004125|Drug|cyclophosphamide|
12071376|NCT00004125|Drug|doxorubicin hydrochloride|
12071377|NCT00004125|Drug|paclitaxel|
12071378|NCT00004125|Drug|tamoxifen citrate|
12071379|NCT00004125|Radiation|radiation therapy|
12071380|NCT00004032|Biological|ALVAC-hB7.1|Given IP
12071381|NCT00004032|Biological|recombinant interferon gamma|Given IP
12071382|NCT00004032|Other|laboratory biomarker analysis|Correlative studies
12071383|NCT00067496|Drug|Modafinil|
12071384|NCT00067457|Drug|alosetron|
12071385|NCT00067444|Drug|Paroxetine CR|
12071386|NCT00067431|Drug|Divalproex Sodium (Depakote® Sprinkle Capsules)|
12071387|NCT00067405|Drug|Intravenous micronutrient therapy|
12071388|NCT00067392|Procedure|Dental Implant|Dental Implant 4 month time frame
12071389|NCT00067340|Drug|Chlorhexidine mouth rinse|women received daily chlorhexidine oral rinses for two weeks prior to delivery of the infant.
12071390|NCT00067340|Other|Xylitol chewing gum|Women were asked to chew xylitol chewing gum three times per day following the birth of their infant for up to two years postpartum
12071391|NCT00004004|Drug|procarbazine hydrochloride|
12071392|NCT00003931|Genetic|reverse transcriptase-polymerase chain reaction|
12071393|NCT00003890|Drug|MG 98|
12071394|NCT00003736|Drug|motexafin gadolinium|
12071395|NCT00003736|Procedure|biopsy|
12071396|NCT00003736|Procedure|breast imaging study|
12071397|NCT00003736|Procedure|comparison of screening methods|
12071398|NCT00003736|Procedure|magnetic resonance imaging|
12071399|NCT00003736|Procedure|study of high risk factors|
12071400|NCT00003464|Drug|temozolomide|
12071401|NCT00003464|Radiation|radiation therapy|
12071402|NCT00067379|Procedure|interceptive orthodontic treatments|orthodontic procedures
12071403|NCT00067366|Behavioral|Cognitive-Behavioral treatment|Cognitive-Behavioral skills training for chronic pain
12071404|NCT00067366|Behavioral|Attention and lifestyle counseling|Attention and lifestyle counseling added to Standard Care
12071405|NCT00067353|Drug|Fluoride varnish|
12071406|NCT00067327|Drug|Inosine|
12071407|NCT00067314|Drug|Edotecarin|
12071408|NCT00067301|Drug|Polyunsaturated Fatty Acids (PUFA)|
12071409|NCT00067301|Drug|Citalopram|
12071410|NCT00067288|Behavioral|Meaning-Centered Group Psychotherapy|
12071411|NCT00067288|Behavioral|Standard Supportive Group Psychotherapy|
12071412|NCT00067262|Drug|Divalproex Sodium Extended-Release Tablets|
12071413|NCT00067236|Drug|PG-116800 (given as PG-530742)|200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
12071414|NCT00067236|Drug|Placebo tablet|placebo tablet, twice a day for 90 days
12071415|NCT00067210|Device|Head and Neck Cooling System|
12071416|NCT00067184|Device|Toitu 320/325|Fetal monitor
12071417|NCT00067171|Behavioral|Behavior Therapy|
12071418|NCT00067158|Drug|nicotine transdermal system|
12071419|NCT00067145|Behavioral|Face-to-face maintenance program|
12071420|NCT00067145|Behavioral|Internet maintenance program|
12071421|NCT00067132|Procedure|Juven (nutritional), HMB (nutritional)|
12071422|NCT00067119|Drug|Aggrenox|
12071423|NCT00067119|Drug|Placebo|
12071424|NCT00067093|Drug|SanOrg34006|
12071425|NCT00067093|Drug|LMW heparin|
12071426|NCT00067093|Drug|Unfractionated heparin|
12071427|NCT00067093|Drug|Vitamin K antagonist (VKA)|
12071428|NCT00067080|Drug|ICL670, deferoxamine|
12071429|NCT00067041|Drug|Remodulin (treprostinil sodium) Injection|
12071430|NCT00067028|Drug|Clofarabine 40mg/m^2|40 mg/m^2 by vein over 1 hour daily for 5 days.
12071431|NCT00067028|Drug|Idarubicin 10mg/m^2|"10 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.
~Clofarabine + Idarubicin plus Ara-C:
~6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."
12071432|NCT00067028|Drug|Ara-C 0.75 g/m^2|0.75 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.
12071433|NCT00067028|Drug|Clofarabine 22.5mg/m^2|22.5 mg/m^2 by vein over 1 hour daily for 5 days.
12071434|NCT00067028|Drug|Ara-C 1 g/m^2|1 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.
12071435|NCT00067028|Drug|Idarubicin 6 mg/m^2|6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.
12071436|NCT00003433|Biological|carcinoembryonic antigen RNA-pulsed DC cancer vaccine|
12071437|NCT00003323|Drug|finasteride|5 mg/d PO
12071438|NCT00003323|Drug|flutamide|250 mg PO tid
12071439|NCT00003323|Other|quality-of-life assessment|Assessment survey administered at baseline, and 3 & 6 months post initiation of treatment
12071440|NCT00003210|Biological|recombinant interleukin-12|Given subcutaneously
12071441|NCT00003210|Other|laboratory biomarker analysis|Correlative studies
12071442|NCT00003114|Biological|filgrastim|Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42.The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
12071443|NCT00003114|Drug|cyclophosphamide|Oral cyclophosphamide on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
12071444|NCT00003114|Drug|etoposide|Oral etoposide on days 1-3. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
12071445|NCT00003114|Drug|lomustine|Patients receive oral lomustine on day 1.
12071446|NCT00003114|Drug|procarbazine hydrochloride|Oral and procarbazine on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
12071447|NCT00003114|Radiation|radiation therapy|Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.
12071448|NCT00003006|Genetic|reverse transcriptase-polymerase chain reaction|
12071449|NCT00003006|Other|immunohistochemistry staining method|
12071452|NCT00067015|Procedure|assessment of therapy complications|
12071453|NCT00067015|Procedure|quality-of-life assessment|
12071454|NCT00067015|Radiation|radiation therapy|
12071455|NCT00067002|Procedure|Expanded allogeneic cord blood (CB)|Transplantation of Two Unmanipulated Cord Blood Units.
12071456|NCT00067002|Procedure|One Unmanipulated and One Expanded Cord Blood Unit|Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.
12071457|NCT00067002|Drug|Rituxan|375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.
12071458|NCT00067002|Drug|Melphalan|140 mg/m2 by vein on Day -8.
12071459|NCT00067002|Drug|Thiotepa|5 mg/Kg by vein on Day -7.
12071460|NCT00067002|Drug|Fludarabine|40 mg/m2 by vein on Days -6 to -3.
12071461|NCT00067002|Drug|Cyclophosphamide|50 mg/kg by vein on Day -6.
12071462|NCT00067002|Drug|Mesna|10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).
12071463|NCT00067002|Radiation|Total body irradiation (TBI)|Total body irradiation (TBI) given on Day -1 at 2 Gy.
12071464|NCT00066989|Drug|Staphylococcus aureus Immune Globulin (Human) 5%|
12071465|NCT00046878|Drug|O6-benzylguanine|
12071466|NCT00046878|Drug|carmustine|
12071467|NCT00002970|Drug|nelarabine|Given IV
12071468|NCT00002970|Drug|methotrexate|Given IT
12071469|NCT00002970|Drug|cytarabine|Given IT
12071470|NCT00002970|Drug|therapeutic hydrocortisone|Given IT
12071471|NCT00002621|Biological|recombinant interferon alfa|
12071472|NCT00002548|Biological|recombinant interferon alfa|"3 million units/m2 SQ Monday-Wednesday
~-Friday (3 times a week)"
12071473|NCT00002548|Drug|carmustine|20 mg/m2 I.V. day 1 q 35 days
12071474|NCT00002548|Drug|cyclophosphamide|1.5 g/m2 in 100 ml of D5W, IV intravenously over 1 hour every 3 hour x 3 (total dose 4.5 g/m2)
12071475|NCT00002548|Drug|dexamethasone|40 mg/day PO or IVPB days 1-4, 9-12, 17-20 q 5 weeks
12071476|NCT00002548|Drug|doxorubicin hydrochloride|10 mg/m2/day continuous 1 - 4 q 5 weeks
12071477|NCT00002548|Drug|melphalan|140 mg/m2 is given IV within 30 minutes of constitution on Day -5
12071478|NCT00002548|Drug|prednisone|40 mg/m2 PO days 1-7 q 35 days
12071479|NCT00002548|Drug|vincristine sulfate|0.5 mg/day continuous 1 - 4 q 5 weeks
12071480|NCT00002548|Procedure|allogeneic bone marrow transplantation|day 0
12071481|NCT00002548|Procedure|autologous bone marrow transplantation|day 0
12071482|NCT00002548|Procedure|peripheral blood stem cell transplantation|day 0
12071483|NCT00002548|Radiation|radiation therapy|administered in fractionated doses of 150 cGy, 6 - 10 hours apart bid, on Days -4, -3, -2, and -1 (Total 1,200 cGy)
12071484|NCT00002520|Drug|nicotine|
12071485|NCT00002520|Behavioral|Usual Care|
12071486|NCT00066963|Device|Fluoride Varnish|0.1 mL (1 drop) applied on each of 2 arches
12071487|NCT00066950|Drug|Chlorhexidine gluconate|0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months
12071488|NCT00066950|Device|Fluoride Varnish|0.25ml FV every 6 months from age 12 to 30 months
12071489|NCT00066937|Drug|Nortriptyline Oral Capsule|Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.
12071490|NCT00066937|Drug|Benztropine Oral Product|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile.
12071491|NCT00066937|Behavioral|CBT|Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.
12071492|NCT00066937|Behavioral|Disease MGT|Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.
12071493|NCT00066898|Drug|AGI-1067|
12071494|NCT00066885|Drug|calcitriol + docetaxel|
12071495|NCT00011973|Drug|fenretinide|
12071496|NCT00005027|Drug|becatecarin|
12071497|NCT00066872|Drug|imiquimod|
12071498|NCT00066872|Procedure|conventional surgery|
12071499|NCT00066859|Drug|Zoloft 50 mg|Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
12071500|NCT00066859|Dietary Supplement|St. John's Wort 600 mg|St. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months.
12071501|NCT00066846|Biological|bevacizumab|
12071502|NCT00066846|Drug|fluorouracil|
12071503|NCT00066846|Drug|leucovorin calcium|
12071504|NCT00066807|Drug|chemotherapy|Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given.
12071505|NCT00066807|Drug|exemestane|Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier.
12071506|NCT00066807|Drug|tamoxifen|Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier.
12071507|NCT00066807|Drug|triptorelin|Triptorelin (GnRH analogue) 3.75 mg by intramuscular injection every 28 days for 5 years from randomization, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed.
12071508|NCT00066807|Procedure|oophorectomy|Bilateral surgical oophorectomy via laparotomy or laparoscopy.
12071509|NCT00066807|Procedure|ovarian irradiation|Bilateral ovarian irradiation.
12071510|NCT00066794|Biological|filgrastim|5 mcg/kg/d IV or SC starting apx day 15
12071511|NCT00066794|Biological|sargramostim|250 mcg/kg/d IV or SC starting apx day 15
12071512|NCT00066794|Drug|cyclosporine|ind: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-74 consol: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-50
12071513|NCT00066794|Drug|cytarabine|ind: 200 mg/m2/d cont IV days 2-74
12071514|NCT00066794|Drug|daunorubicin hydrochloride|ind: 45 mg/m2/d cont IV days 2-74
12071515|NCT00066781|Drug|gemcitabine hydrochloride|Given IV
12071516|NCT00066781|Drug|irinotecan hydrochloride|Given IV
12071517|NCT00066768|Drug|suramin|Given IV
12071518|NCT00066768|Drug|docetaxel|Given IV
12071519|NCT00066768|Drug|gemcitabine hydrochloride|Given IV
12071520|NCT00066768|Other|laboratory biomarker analysis|Correlative studies
12071521|NCT00066768|Other|pharmacological study|Correlative studies
12071522|NCT00066742|Drug|tirapazamine|Given IV
12071523|NCT00066742|Drug|cisplatin|Given IV
12071524|NCT00066742|Drug|etoposide|Given IV
12071525|NCT00066742|Radiation|radiation therapy|Undergo radiation therapy
12071526|NCT00066742|Other|laboratory biomarker analysis|Correlative studies
12071527|NCT00066729|Biological|NY-ESO-1 peptide vaccine|
12071528|NCT00066729|Biological|incomplete Freund's adjuvant|
12071529|NCT00066716|Drug|carboplatin|Dosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43.
12071530|NCT00066716|Drug|celecoxib|400 mg orally BID begins 3-7 days before the first dose of chemotherapy to the morning of surgery. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year total, that is, 1 year from the date of surgery + 2 weeks unless tumor recurrence is documented.
12071531|NCT00066716|Drug|paclitaxel|200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.
12071532|NCT00066716|Procedure|adjuvant therapy|"Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
~Operation will be performed within 6-12 hours from the last dose of celecoxib.
~Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.
~Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year."
12071533|NCT00066716|Procedure|conventional surgery|"Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
~Operation will be performed within 6-12 hours from the last dose of celecoxib.
~Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection."
12071534|NCT00066716|Procedure|neoadjuvant therapy|"Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
~Operation will be performed within 6-12 hours from the last dose of celecoxib.
~Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection."
12071535|NCT00066703|Drug|exemestane|
12071536|NCT00066703|Drug|tamoxifen|
12071537|NCT00066703|Drug|triptorelin|
12071538|NCT00066690|Drug|Exemestane|Exemestane 25mg orally daily for 5 years plus ovarian function suppression
12071539|NCT00066690|Other|Laboratory Biomarker Analysis|Correlative studies
12071540|NCT00066690|Procedure|Oophorectomy|Undergo bilateral surgical oophorectomy
12071541|NCT00066690|Other|Quality-of-Life Assessment|Ancillary studies
12071542|NCT00066690|Radiation|Radiation Therapy|Undergo ovarian irradiation
12071543|NCT00066690|Drug|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
12071544|NCT00066690|Drug|Triptorelin|3.75 mg by im injection q28 days for 5 years
12071545|NCT00066677|Biological|bevacizumab|
12071546|NCT00066677|Drug|docetaxel|
12071547|NCT00066664|Genetic|proteomic profiling|
12071548|NCT00066651|Biological|SS1(dsFv)-PE38 immunotoxin|
12071549|NCT00066638|Drug|Romidepsin|Given IV
12071550|NCT00066638|Other|Laboratory Biomarker Analysis|Correlative studies
12071551|NCT00066625|Drug|oxaliplatin|Given IV
12071552|NCT00066625|Drug|bortezomib|Given IV
12071553|NCT00066625|Other|laboratory biomarker analysis|Correlative studies
12071554|NCT00066625|Other|pharmacological study|Correlative studies
12071555|NCT00066612|Drug|irinotecan hydrochloride|Irinotecan will be given 250 mg/m^2 through intravenous (IV) for 90 minutes on day 1 for every 21 days until tumor progression or unacceptable toxicity or other reason for discontinuation occurs
12071556|NCT00066599|Drug|voriconazole|
12071557|NCT00066586|Drug|exemestane|exemestane 25 mg once daily x 1 year
12071558|NCT00066586|Drug|Placebo|placebo once daily x 1 year
12071559|NCT00066573|Drug|anastrozole|Given orally
12071560|NCT00066573|Drug|exemestane|Given orally
12071561|NCT00066547|Biological|monoclonal antibody HuHMFG1|
12071562|NCT00066508|Drug|bortezomib|
12071563|NCT00066482|Biological|bleomycin sulfate|Given IV over 10 minutes. Children ≥ 12 months: 15 units/m2/dose Children < 12 months: 0.5 units/kg/dose Day 1 (Week 1, 4, 7, 10)
12071564|NCT00066482|Biological|filgrastim|Given SQ once daily 5 micrograms/kg/dose Starting on Day 6 (Week 1, 4, 7, 10) Daily until ANC > 5,000/uL
12071565|NCT00066482|Drug|cisplatin|Children ≥ 12 months: Given IV over one hour Dose: 20 mg/m2/dose Days 1-5 (Week 1,4,7,10) Children < 12 months: Given IV over 4 hours, 0.67 mg/kg/dose Days 1-5 (Week 1,4,7,10)
12071566|NCT00066482|Drug|cyclophosphamide|Given IV over 1 hour. Children ≥ 12 months: Level 1: 1.2 g/m2/dose Level 2: 1.8 g/m2/dose Level 3: 2.4 g/m2/dose Children < 12 months: Level 1: 40 mg/kg/dose Level 2: 60 mg/kg/dose Level 3: 80 mg/kg/dose Day 1 (Week 1, 4, 7, 10)
12071567|NCT00066482|Drug|etoposide|Given IV over 1 hour. Children ≥ 12 months: 100 mg/m2/dose Children < 12 months: 3.3 mg/kg/dose Day 1-5 (Week 1, 4, 7, 10)
12071568|NCT00066482|Procedure|conventional surgery|Stage III/IV extragonadal tumors: biopsy followed by a definitive surgical excision after maximal chemotherapy effect, likely after 4 cycles of therapy
12071569|NCT00066482|Biological|MESNA|Given IV or oral. The total daily MESNA dose is equal to at least 80% of the daily CPM dose. The oral dose of MESNA is 2x the IV dose. Day 1 (Week 1,4,7,10) To be given with CPM.
12071570|NCT00066469|Biological|rituximab|Cycles 1 and 2 only: Given IV Incremental: First dosage: < 21 years of age: 0.5mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 50 mg/hr for the 1st hour. Subsequent dosages: < 21 years of age: 1.0mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 100 mg/hr for the 1st hour. Days 1, 8 and 15.
12071571|NCT00066469|Drug|cyclophosphamide|Given IV over 30-60 minutes Dose 600 mg/m2 in 50-250 mL of normal saline (NS) or Dextrose-Water 5%(D5W) (at a maximum concentration of 20 mg/ml) over 30-60 minutes on day 1 of each cycle
12071572|NCT00066469|Drug|methylprednisolone|Methylprednisolone 0.8 mg/kg IV over 12 hours on days 1,2,3,4 and 5 of each cycle.
12071573|NCT00066469|Drug|prednisone|Dosage 1 mg/kg orally every 12 hours on days 1,2,3,4 and 5 of each cycle. Oral prednisone may be rounded up to the nearest 2.5 mg as necessary for tablet size
12071574|NCT00066456|Radiation|3-Dimensional Conformal Radiation Therapy|
12071575|NCT00066456|Drug|Chemosensitization/Potentiation Therapy|
12071576|NCT00066456|Drug|Docetaxel|Given IV
12071577|NCT00066443|Biological|pegfilgrastim|Dose escalation schedule A&B = 6mg fixed dose once per cycle on day 2
12071578|NCT00066443|Drug|docetaxel|Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2
12071579|NCT00066443|Drug|epirubicin hydrochloride|Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV
12071580|NCT00066430|Procedure|infrared photocoagulation therapy|
12071581|NCT00066430|Device|Infrared Coagulator|IRC treatment of up to 3 HGAIN lesions at baseline (study initiation). A second IRC treatment may be administered for recurrent lesions at the 3 month visit.
12071582|NCT00066417|Drug|cyclophosphamide|
12071583|NCT00066417|Drug|cyclosporine|
12071584|NCT00066417|Drug|fludarabine phosphate|
12071585|NCT00066417|Drug|methylprednisolone|
12071586|NCT00066417|Drug|therapeutic allogeneic lymphocytes|
12071587|NCT00066417|Drug|thiotepa|
12071588|NCT00066417|Procedure|allogeneic bone marrow transplantation|
12071589|NCT00066417|Procedure|biological therapy|
12071590|NCT00066417|Procedure|bone marrow ablation with stem cell support|
12071591|NCT00066417|Procedure|bone marrow transplantation|
12071592|NCT00066417|Procedure|chemotherapy|
12071593|NCT00066417|Procedure|leukocyte therapy|
12071594|NCT00066417|Procedure|non-specific immune-modulator therapy|
12071595|NCT00066417|Procedure|peripheral blood lymphocyte therapy|
12071596|NCT00066417|Procedure|peripheral blood stem cell transplantation|
12071597|NCT00066417|Procedure|radiation therapy|
12071598|NCT00066404|Biological|recombinant adenovirus-hIFN-beta|
12071599|NCT00066391|Drug|cisplatin|
12071600|NCT00066391|Drug|irinotecan hydrochloride|
12071601|NCT00066391|Procedure|neoadjuvant therapy|
12071602|NCT00066378|Drug|anastrozole|
12071603|NCT00066378|Drug|gefitinib|
12071604|NCT00066365|Biological|sargramostim|given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
12071605|NCT00066365|Procedure|conventional surgery|thoracotomy
12071606|NCT00066352|Drug|bortezomib|
12071607|NCT00066339|Drug|gefitinib|
12071608|NCT00066326|Drug|imatinib mesylate|
12071609|NCT00066326|Drug|tanespimycin|
12071610|NCT00066313|Drug|vandetanib|
12071611|NCT00066313|Procedure|adjuvant therapy|
12071612|NCT00066274|Drug|FOLFIRI regimen|
12071613|NCT00066274|Drug|FOLFOX regimen|
12071614|NCT00066274|Drug|fluorouracil|
12071615|NCT00066274|Drug|irinotecan hydrochloride|
12071616|NCT00066274|Drug|leucovorin calcium|
12071617|NCT00066274|Drug|oxaliplatin|
12071618|NCT00066248|Drug|cyproheptadine hydrochloride|Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
12071619|NCT00066248|Drug|megestrol acetate|Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
12071620|NCT00066222|Drug|Cisplatin|60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64.
12071621|NCT00066222|Drug|Etoposide|120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66.
12071622|NCT00066222|Radiation|Radiation therapy|Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.
12071623|NCT00066196|Biological|MEDI--522|IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
12071624|NCT00066196|Biological|Integrin + Dacarbazine|supplied in other formulations
12071625|NCT00020462|Biological|aldesleukin|
12071626|NCT00020462|Biological|autologous tumor cell vaccine|
12071627|NCT00019721|Biological|MART-1 antigen|
12071628|NCT00019721|Biological|aldesleukin|
12071629|NCT00019721|Biological|gp100 antigen|
12071630|NCT00019721|Biological|incomplete Freund's adjuvant|
12071631|NCT00019383|Biological|aldesleukin|
12071632|NCT00019383|Biological|incomplete Freund's adjuvant|
12071633|NCT00019383|Biological|sargramostim|
12071634|NCT00019383|Biological|tyrosinase peptide|
12071635|NCT00019383|Biological|tyrosinase-related protein-1|
12071636|NCT00066170|Drug|Xyrem|Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
12071637|NCT00066170|Drug|Xyrem Placebo|Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
12071638|NCT00066170|Drug|Modafinil at established dose|Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
12071639|NCT00066170|Drug|Modafinil (Placebo)|Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
12071640|NCT00033722|Dietary Supplement|folic acid|
12071641|NCT00033722|Drug|lometrexol|
12071642|NCT00033306|Drug|ixabepilone|
12071643|NCT00033306|Drug|Fluoropyrimidine|
12071644|NCT00033306|Drug|Irinotecan|
12071645|NCT00031811|Drug|raloxifene|
12071646|NCT00031811|Procedure|quality-of-life assessment|
12071647|NCT00031785|Drug|megestrol acetate|
12071648|NCT00031785|Radiation|radiation therapy|
12071649|NCT00066157|Drug|Transdermal estradiol|50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months
12071650|NCT00066157|Drug|Medroxyprogesterone|2.5mg tablet daily for 12 months
12071651|NCT00066157|Drug|Placebo Patch|Transdermal placebo patch, changed every 3 days, for 12 months
12071652|NCT00066157|Drug|Placebo|Placebo tablet daily for 12 months
12071653|NCT00066144|Drug|Cimicifuga racemosa|
12071654|NCT00066144|Drug|Trifolium pratense|
12071655|NCT00066144|Drug|Black cohosh|
12071656|NCT00066144|Drug|Red clover|
12071657|NCT00066131|Procedure|Periodontal scaling and root planing|Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.
12071658|NCT00066131|Procedure|Scaling and root planing|Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.
12071659|NCT00066118|Device|Dental amalgam restorations|
12071660|NCT00066092|Drug|pegfilgrastim 12 mg|Pegfilgrastim 12 mg given once for PBPC mobilization
12071661|NCT00066092|Drug|filgrastim|Filgrastim given daily for PBPC mobilization
12071662|NCT00066092|Drug|pegfilgrastim 6 mg|Pegfilgrastim 6 mg given once for PBPC mobilization
12071663|NCT00066079|Procedure|massage|
12071664|NCT00066079|Behavioral|relaxation|
12071665|NCT00066066|Procedure|Scaling and root planing|Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy.
12071666|NCT00066066|Drug|Metronidazole|Metronidazole (MET) is an antibiotic that is particularly effective against Gram negative bacterial species. The dose for this study is: 250 mg tid x 14d.
12071667|NCT00066066|Drug|Amoxicillin|Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d.
12071668|NCT00066066|Drug|Doxycycline|The ATRIDOX (doxycycline hyclate) ® product is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DLlactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days. Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline.
12071669|NCT00066053|Procedure|Periodontal Treatment: SRP|Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions.
12071670|NCT00066053|Procedure|Referral|
12071671|NCT00066040|Drug|Cervitec chlorhexidine varnish|
12071672|NCT00066040|Drug|Duraphat fluoride varnish|
12071673|NCT00066040|Drug|xylitol gum from Fennobon, Finland|
12071674|NCT00066027|Drug|20 mg doxycycline hyclate|Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years
12071675|NCT00066027|Drug|Placebo|Subjects in the placebo group took a placebo look-alike twice daily for two years.
12071676|NCT00066014|Procedure|Implant Overdenture Treatment|All overdenture treatment modalities were provided to each subject using a crossover design.
12071677|NCT00066001|Drug|metronidazole|antibiotic that is particularly effective against Gram negative bacterial species
12071678|NCT00065988|Device|Dispersed phase amalgam restoration /composite restoration|
12071679|NCT00065975|Procedure|massage therapy|
12071680|NCT00065975|Procedure|chiropractic|
12071681|NCT00065975|Procedure|acupuncture|
12071682|NCT00065962|Drug|secretin, synthetic porcine|
12071683|NCT00065962|Drug|secretin, biologically derived porcine|
12071684|NCT00065949|Drug|magnesium sulfate|
12071685|NCT00065936|Drug|Naltrexone hydrochloride|
12071686|NCT00065936|Procedure|Transcutaneous sensory nerve stimulation|
12071687|NCT00065923|Drug|Topiramate|
12071688|NCT00065910|Behavioral|Caregiver joint attention intervention|
12071689|NCT00065897|Procedure|Amniocentesis|
12071690|NCT00065897|Procedure|Transabdominal chorionic villus sampling (TA CVS)|
12071691|NCT00065884|Drug|Valproate|
12071692|NCT00065871|Behavioral|Contraceptive Screening by Pharmacist|
12071693|NCT00065871|Behavioral|Contraceptive Prescribing by Pharmacist|
12071694|NCT00065858|Drug|BufferGel|
12071695|NCT00065845|Procedure|Burch urethropexy at time of sacrocolpopexy|The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
12071696|NCT00031707|Dietary Supplement|eicosapentaenoic acid|
12071697|NCT00031707|Drug|megestrol acetate|
12071698|NCT00031707|Other|placebo|
12071699|NCT00026273|Drug|FOLFIRI regimen|
12071700|NCT00026273|Drug|fluorouracil|
12071701|NCT00026273|Drug|irinotecan hydrochloride|
12071702|NCT00026273|Drug|leucovorin calcium|
12071703|NCT00025688|Drug|carboplatin|
12071704|NCT00025688|Drug|paclitaxel|
12071705|NCT00024024|Drug|rebimastat|
12071706|NCT00022477|Drug|BMS-247550|
12071707|NCT00065832|Behavioral|Reading Instruction|
12071708|NCT00065819|Behavioral|HIV Symptom Education Program|
12071709|NCT00065806|Drug|Atorvastatin|Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.
12071710|NCT00065806|Drug|Placebo atorvastatin|Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.
12071711|NCT00065767|Drug|Raloxifene|
12071712|NCT00065754|Drug|placebo|
12071713|NCT00065741|Drug|silymarin|
12071714|NCT00065728|Drug|Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL|One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
12071715|NCT00065715|Dietary Supplement|Echinacea|Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. B) Echinacea angustifolia - 600 mg root yields 150 mg dried extract, standardized to contain 2.0 mg alkamides. Each batch of tablets is analyzed by Reversed Phase - High Peformance Liquid Chromatography to determine the levels of alkamides and caffeic derivatives present. Caffeic acid derivative levels are typically as follows: caftaric acid = 0.5 to 2.0 mg/tablet; cichoric acid = 3.4 to 8.5 mg/tablet; chlorogenic acid = < 0.5 mg/tablet; dicaffeoyl quinic acids (including cynarin) = 0.7 to 2.0 mg/tablet; echinacoside = 1.0 to 1.7 mg/tablet
12071716|NCT00065715|Other|Blinded placebo|Blinded placebo - Coated tablet
12071717|NCT00065702|Drug|Active liquid remedy|
12071718|NCT00065689|Device|high-intensity light therapy|
12071719|NCT00065676|Other|Quercetin|1 or 2 grams of quercetin or placebo will be given while patients undergo 6-hour OGTT
12071720|NCT00065676|Other|Placebo|
12071721|NCT00065663|Genetic|GAM501|
12071722|NCT00065650|Drug|Vedic Medicine|
12071723|NCT00065650|Behavioral|Vedic Medicine|
12071724|NCT00065624|Drug|lipoic acid|
12071725|NCT00065585|Procedure|Accupuncture|
12071726|NCT00065572|Drug|ZD6126|
12071727|NCT00065572|Drug|Placebo|
12071728|NCT00065559|Drug|celecoxib|
12071729|NCT00065546|Other|Estrogen plus choline depletion diet|Post-menopausal subjects receive estrogen and are then challenged with a low choline diet to determine if estrogen protects them from induction of choline deficiency.
12071730|NCT00065546|Other|Placebo plus choline depletion diet|Post-menopausal women are randomized to receive a placebo and are then subjected to a low choline diet to determine if clinical signs of choline deficiency can be induced.
12071731|NCT00065546|Other|Pre-menopausal women with SNPs given a low choline diet|Pre-menopausal women with specific genetic polymorphisms in genes related to choline metabolism are placed on a choline depletion diet to determine if the SNPs increase or decrease the risk of diet-induced choline deficiency.
12071732|NCT00065637|Drug|Teriparatide|Synthetic human parathyroid hormone
12071733|NCT00065637|Drug|Placebo teriparatide|Placebo injections
12071734|NCT00014560|Biological|bispecific antibody 4G7xH22|
12071735|NCT00014560|Biological|sargramostim|
12071736|NCT00014261|Biological|PEG-interferon alfa-2b|
12071737|NCT00014261|Drug|temozolomide|
12071738|NCT00014248|Drug|adenosine triphosphate|
12071739|NCT00014248|Procedure|quality-of-life assessment|
12071740|NCT00014209|Drug|cisplatin|
12071741|NCT00014209|Drug|dexamethasone|
12071742|NCT00014209|Drug|gemcitabine hydrochloride|
12071743|NCT00010127|Biological|therapeutic autologous dendritic cells|
12071744|NCT00065611|Drug|Oral dexamethasone|"Stage I: Dexamethasone 25 mg/m2, 2 doses every 2 weeks over 48 weeks or dexamethasone 25 mg/m2, 4 doses every 4 weeks over 48 weeks.
~Stage II: 1.) Dexamethasone 50 mg/m2, 2 daily doses every 12 weeks, followed by 25 mg/m2, 2 daily doses every 2 weeks over 36 weeks, or 2.) Dexamethasone 50 mg/m2, 4 daily doses every 4 weeks over 12 weeks, followed by 25 mg/m2, 4 daily doses every 4 weeks over 36 weeks.
~over 36 weeks."
12071745|NCT00065533|Drug|pemetrexed|
12071746|NCT00065507|Drug|Entecavir (ETV)|Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized
12071747|NCT00065507|Drug|Adefovir (ADV)|Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized
12071748|NCT00006799|Drug|megestrol acetate|
12071749|NCT00006799|Procedure|quality-of-life assessment|
12071750|NCT00006486|Drug|carboxyamidotriazole|Given orally
12071751|NCT00006486|Other|placebo|Given orally
12071752|NCT00006453|Drug|carboplatin|
12071753|NCT00006453|Drug|gemcitabine hydrochloride|
12071754|NCT00006352|Biological|BCG vaccine|
12071755|NCT00006352|Biological|monoclonal antibody BEC2|
12071756|NCT00006240|Biological|sargramostim|
12071757|NCT00006240|Drug|dexamethasone|
12071758|NCT00006240|Drug|oral sodium phenylbutyrate|
12071759|NCT00065468|Drug|Interferon Alfa|Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.
12071760|NCT00065468|Drug|CCI-779|25 mg of CCI-779 given Intra Venously once per week
12071761|NCT00065468|Drug|Interferon Alfa and CCI-779|15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week
12071762|NCT00006229|Drug|carboplatin|
12071763|NCT00006229|Drug|paclitaxel|
12071764|NCT00006229|Drug|rebimastat|
12071765|NCT00006081|Drug|Bryostatin-1|40 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16).
12071766|NCT00006081|Drug|Paclitaxel (Taxol)|80 mg/m^2 one-hour infusion weekly x 3 every 4 weeks
12071767|NCT00065455|Drug|Vitamin A|
12071768|NCT00065442|Biological|Sipuleucel-T|Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
12071769|NCT00065442|Biological|APC-Placebo|Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
12071770|NCT00065429|Drug|BB-10901|"I.V. Infusion - See Arms for dosage - Once/Week for three weeks - Until Progression of disease."
12071771|NCT00005604|Biological|recombinant interleukin-12|Given IV
12071772|NCT00005604|Biological|aldesleukin|Given SC
12071773|NCT00005604|Other|laboratory biomarker analysis|Correlative studies
12071774|NCT00004887|Drug|carboplatin|
12071775|NCT00004887|Drug|cisplatin|
12071776|NCT00004887|Drug|ifosfamide|
12071777|NCT00004887|Drug|mitomycin C|
12071778|NCT00004887|Drug|paclitaxel|
12071779|NCT00004887|Drug|vinblastine sulfate|
12071780|NCT00065416|Procedure|massage|
12071781|NCT00065403|Device|Acupuncture|
12071782|NCT00065364|Behavioral|Newborn Individualized Developmental Care Assessment Program|
12071783|NCT00065351|Drug|CC-5013|CC-5013 - oral - 30mg daily on days 1-21 every 28 days
12071784|NCT00065338|Behavioral|Exercise and behavior modification|Participants will undergo 1000 kcal/day caloric restriction (relative to experimentally determined weight-maintenance caloric needs) for 8 weeks during one phase of study. Additional 11 week period consists of 8 weeks of caloric restriction with an additional daily walking program.
12071785|NCT00065325|Drug|Fulvestrant|intramuscular injection
12071786|NCT00065325|Drug|Exemestane|oral capsule
12071787|NCT00004253|Drug|carboplatin|
12071788|NCT00004253|Drug|paclitaxel|
12071789|NCT00004253|Radiation|radiation therapy|
12071790|NCT00065390|Drug|Pyrimethamine|
12071791|NCT00065377|Drug|Glucosamine Hydrochloride|
12071792|NCT00065312|Drug|naveglitazar|
12071793|NCT00065299|Behavioral|Restricted phenylalanine diet|
12071794|NCT00065273|Drug|risperidone|
12071795|NCT00065273|Drug|clozapine|
12071796|NCT00065273|Drug|olanzapine|
12071797|NCT00065247|Behavioral|Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project|
12071798|NCT00065234|Procedure|Acupuncture|
12071799|NCT00065221|Drug|Ginger|
12071800|NCT00065208|Behavioral|Reiki|Energy therapy - 8 biweekly sessions of 30 minutes
12071801|NCT00065208|Behavioral|Pretend Reiki|Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
12071802|NCT00065208|Behavioral|Rest / Guided Imagery|4 weekly sessions of 30 supine rest listening to soft music. One session of Guided Imagery followed at visit 9. Listen to CDs twice a day 3 days prior to and 2 days following surgery (affect only post surgery outcomes)
12071803|NCT00065260|Drug|Campath-1H|Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day).
12071804|NCT00065260|Drug|r-ATG|Rabbit ATG 3.5mg/kg/day for consecutive 5 days
12071805|NCT00065260|Drug|CsA|CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs.
12071806|NCT00065195|Procedure|Moving touch therapy|
12071807|NCT00065195|Procedure|Nonmoving touch therapy|
12071808|NCT00065182|Drug|Topotecan/Docetaxel combination|
12071809|NCT00065182|Drug|Docetaxel|
12071810|NCT00065169|Drug|Celecoxib|
12071811|NCT00065156|Drug|lenalidomide|10 mg orally once daily for 21 days out of a 28-day cycle (syncopated); subsequently amended (Amendment 1, dated 27 August 2003) to employ a continuous dosage regimen in which 10 mg was taken once daily for 28 day cycles (continuous). Subjects who initially began a syncopated regimen and who did not experience a dose-limiting adverse event were allowed to switch to the continuous regimen.
12071812|NCT00065143|Drug|clofarabine|
12071813|NCT00065143|Drug|Ara-C|
12071814|NCT00065130|Drug|human insulin|
12071815|NCT00065130|Drug|insulin NPH|
12071816|NCT00065130|Drug|insulin aspart|
12071817|NCT00065117|Drug|ZD6126|
12071818|NCT00065117|Drug|Placebo|
12071819|NCT00065117|Drug|5-fluorouracil|
12071820|NCT00065117|Drug|leucovorin|
12071821|NCT00065117|Drug|oxaliplatin|
12071822|NCT00065104|Drug|DHEA|
12071823|NCT00065078|Procedure|Home dispensing of contraception|
12071824|NCT00065065|Drug|Rosiglitazone|4mg orally twice daily for 12 weeks
12071825|NCT00065065|Drug|Placebo|pill that looks identical to rosiglitazone
12071826|NCT00065052|Behavioral|Behavior modification|
12071827|NCT00065039|Behavioral|Promotion of a healthy diet and physical activity|
12071828|NCT00065039|Behavioral|Avoidance of Alcohol, Drugs, and Tobacco|
12071829|NCT00065026|Behavioral|Physical activity opportunities for low-income women|
12071830|NCT00065013|Behavioral|strength training|
12071831|NCT00065000|Behavioral|Water, Cafeteria and Staff Health Promotion|
12071832|NCT00004204|Drug|temozolomide|
12071833|NCT00004006|Biological|filgrastim|
12071834|NCT00004006|Drug|carboplatin|
12071835|NCT00004006|Drug|cyclophosphamide|
12071836|NCT00004006|Drug|doxorubicin hydrochloride|
12071837|NCT00004006|Drug|etoposide|
12071838|NCT00004006|Drug|topotecan hydrochloride|
12071839|NCT00004006|Procedure|autologous bone marrow transplantation|
12071840|NCT00004006|Radiation|radiation therapy|
12071841|NCT00003895|Biological|HPV 16 E7:12-20|Given SC
12071842|NCT00003895|Biological|gp100:209-217(210M)|Given SC
12071843|NCT00003895|Other|laboratory biomarker analysis|Correlative studies
12071844|NCT00003795|Procedure|quality-of-life assessment|
12071845|NCT00003759|Biological|BCG vaccine|
12071846|NCT00003759|Drug|valrubicin|
12071847|NCT00003759|Procedure|conventional surgery|
12071848|NCT00064987|Procedure|Testicular biopsy|Outpatient surgical procedure.
12071849|NCT00064987|Drug|gonadotropin releasing hormone (GnRH)|Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels)
12071850|NCT00064987|Drug|follicle stimulating hormone (FSH)|75 IU subcutaneous injection daily for four months.
12071851|NCT00064974|Drug|CC-5013|CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
12071852|NCT00064961|Behavioral|Individualized dietary-control and exercise program|
12071853|NCT00064961|Behavioral|Weight-management and smoking cessation maintenance|
12071854|NCT00064961|Behavioral|Smoking Cessation program|
12071855|NCT00064935|Procedure|Endometrial biopsy|
12071856|NCT00064922|Behavioral|Behavior Therapy|
12071857|NCT00064857|Drug|Pycnogenol|
12071858|NCT00064896|Procedure|MRI|
12071906|NCT00003045|Radiation|XRT|external beam radiation to a dose of 4500 cGy to a small pelvic field, followed by a boost to a reduced volume for an additional 2160 cGy. XRT is given daily, 5 days a week for 180 cGy per day. Total radiation dose=6660cGy
12071907|NCT00003008|Drug|indinavir sulfate|
12071908|NCT00003008|Drug|nelfinavir mesylate|
12071909|NCT00003008|Drug|paclitaxel|
12071910|NCT00003008|Drug|ritonavir|
12071911|NCT00003008|Drug|saquinavir mesylate|
12071912|NCT00002965|Biological|Recombinant Interferon Alfa (INF alpha)|Subcutaneous injection Monday through Friday for 8 weeks.
12071859|NCT00064844|Behavioral|Cognitive Behavior Therapy for alcohol and smoking cessation|Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devoted to alcohol treatment. Components of this intervention included identifying alcohol antecedents, coping with alcohol urges, managing thoughts about alcohol, problem solving, drink refusal skills, planning for emergencies, communication and assertiveness training and enhancing social support networks for alcohol abstinence. The smoking cessation intervention was delivered in the same sessions as the alcohol treatment, with approximately 15-20 minutes of each session devoted to smoking cessation. Treatment employed behavioral elements that have been supported empirically according to the USDHHS smoking cessation practice guideline.
12071860|NCT00064831|Drug|Black Cohosh Extract (BCE)|
12071861|NCT00064805|Behavioral|Cognitive Therapy to Improve Reading|
12071862|NCT00064779|Drug|IL13-PE38QQR|
12071863|NCT00064779|Procedure|targeted fusion protein therapy|
12071864|NCT00064779|Procedure|surgery|
12071865|NCT00064766|Drug|doxycycline|
12071866|NCT00064753|Drug|High Dose Multivitamin|Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
12071867|NCT00064753|Device|Low Dose Multivitamin|Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
12071868|NCT00003712|Drug|temsirolimus|"•Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
~The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.
~•Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II."
12071869|NCT00003707|Drug|gemcitabine hydrochloride|
12071870|NCT00003707|Drug|tipifarnib|
12071871|NCT00003645|Drug|Flutamide|10.8 mg intramuscularly once every 3 months for 12 months
12071872|NCT00003645|Drug|Leuprolide Acetate|50 mg tablet orally daily for 12 months
12071873|NCT00003571|Genetic|mutation analysis|
12071874|NCT00003571|Genetic|tumor replication error analysis|
12071875|NCT00003382|Biological|filgrastim|
12071876|NCT00003382|Drug|gemcitabine hydrochloride|
12071877|NCT00003382|Drug|topotecan hydrochloride|
12071878|NCT00064792|Drug|Simvastatin Susp.|During the simvastatin phase of the trial, therapy will be initiated at 0.5 mg/kg/day for six weeks and then increased to 1.0 mg/kg/day if adverse side effects are minimal or absent.
12071879|NCT00064792|Drug|OraPlus|During this trial and for two months prior, patients will be maintained on 150 mg/kg/day of dietary cholesterol (150 mg/ml in OraPlus) for the duration of the trial
12071880|NCT00064740|Behavioral|relaxation response|
12071881|NCT00064701|Drug|Tacrolimus Modified Release (MR)|The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter.
12071882|NCT00064701|Drug|Tacrolimus|The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter.
12071883|NCT00064701|Drug|cyclosporine microemulsion|The target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter.
12071884|NCT00064701|Drug|mycophenolate mofetil|Oral
12071885|NCT00064727|Drug|Avandia (Rosiglitazone)|
12071886|NCT00064727|Drug|Avanclia (Rosiqlitazone)|
12071887|NCT00064714|Drug|AC2993 (exenatide)|Dose-escalation beginning with 2.5 μg administered subcutaneously twice per day (BID); then to 2.5 μg four times a day (QID); then to 5 μg four times a day; then to 10 μg four times a day.
12071888|NCT00064714|Drug|daclizumab (immunosuppressive)|2 mg/kg intravenously infused over 30 minutes every month for 12 months
12071889|NCT00064662|Procedure|Burch Modified Tanagho|The Burch colposuspension is a well-established procedure for surgically treating women with stress urinary incontinence. The Burch modified colposuspension suspends the anterior vaginal wall (at the level of the bladder neck) with permanent sutures tied to the iliopectineal ligament.
12071890|NCT00064662|Procedure|Autologous Fascia Sling|The fascial sling is also a well-established procedure for surgically treating women with stress urinary incontinence. The autologous sling procedure places a harvested strip of rectus fascia transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures
12071891|NCT00064649|Device|Transurethral Microwave Thermotherapy (TUMT)|type of minimally invasive surgical therapy for BPH
12071892|NCT00064649|Device|Transurethral Needle Ablation (TUNA) Therapy|type of minimally invasive surgical therapy for BPH
12071893|NCT00064649|Drug|Finasteride and Alfuzosin|finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
12071894|NCT00064636|Drug|VELCADE TM (bortezomib) for Injection, or PS-341|
12071895|NCT00064623|Drug|Capsaicin Dermal Patch|
12071896|NCT00064610|Drug|VELCADE TM (bortezomib) for Injection|
12071897|NCT00063726|Drug|bortezomib|
12071898|NCT00003350|Drug|paclitaxel|Given IV
12071899|NCT00003350|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
12071900|NCT00003350|Other|laboratory biomarker analysis|Correlative studies
12071901|NCT00003350|Procedure|quality-of-life assessment|Ancillary studies
12071902|NCT00003184|Biological|BCG vaccine|
12071903|NCT00003184|Biological|CD80 breast cancer vaccine|
12071904|NCT00003184|Biological|sargramostim|
12071905|NCT00003045|Device|Hyperthermia|Hyperthermia is delivered by the transrectal ultrasound applicator just prior to XRT, at least one week apart, during the first 4 weeks of XRT. The goal of hyperthermia is CEM T 90 43 greater than or equal to 10 minutes. The maximum applied power duration will be 120 minutes per treatment session
12071913|NCT00064584|Drug|CT53518|
12071914|NCT00064571|Procedure|vocal fold medialization|
12071915|NCT00064571|Procedure|vocal fold reinnervation|
12071916|NCT00064467|Drug|Extended-release bupropion (HCl)|
12071917|NCT00064454|Drug|OPC-6535 Tablets (drug)|
12071918|NCT00064441|Drug|OPC-6535 Tablets (drug)|
12071919|NCT00064415|Drug|arformoterol|Arformoterol inhalation solution, 50 mcg QD
12071920|NCT00064415|Drug|Salmeterol|Salmeterol MDI, 42 mcg BID
12071921|NCT00064402|Drug|arformoterol tartrate inhalation solution|arformoterol 50 mcg QD
12071922|NCT00064402|Drug|arformoterol tartrate inhalation solution|arformoterol 25 mcg BID
12071923|NCT00064402|Drug|arformoterol tartrate inhalation solution|arformoterol 15 mcg BID
12071924|NCT00064402|Drug|Salmeterol|Salmeterol MDI 42 mcg BID
12071925|NCT00064402|Drug|Placebo|Placebo BID
12071926|NCT00064389|Drug|levalbuterol tartrate HFA MDI|levalbuterol MDI 90 mcg QID
12071927|NCT00064389|Drug|racemic albuterol|racemic albuterol HFA MDI 180 mcg QID
12071928|NCT00064376|Drug|paricalcitol|
12071929|NCT00064363|Drug|talampanel|
12071930|NCT00064350|Drug|Sorafenib|"Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo.
~Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study.
~Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death."
12071931|NCT00064350|Drug|Placebo|Patients randomized to the placebo arm in step 2 continued receiving placebo until disease progression or one year from randomization. Placebo was given orally twice a day (BID).
12071932|NCT00064337|Biological|filgrastim|
12071933|NCT00064337|Drug|cyclophosphamide|
12071934|NCT00064337|Drug|dexamethasone|
12071935|NCT00064337|Drug|melphalan|
12071936|NCT00064337|Drug|thalidomide|
12071937|NCT00064337|Procedure|peripheral blood stem cell transplantation|
12071938|NCT00064324|Drug|perifosine|Given orally
12071939|NCT00064324|Other|laboratory biomarker analysis|Correlative studies
12071940|NCT00064324|Other|pharmacological study|Correlative studies
12071941|NCT00064311|Drug|ravuconazole|
12071942|NCT00064298|Dietary Supplement|fruit and vegetable extracts|Given orally
12071943|NCT00064298|Dietary Supplement|placebo|Given orally
12071944|NCT00064285|Drug|alvocidib|
12071945|NCT00064285|Drug|imatinib mesylate|
12071946|NCT00064272|Drug|ginger extract|Given orally
12071947|NCT00064272|Other|placebo|Given orally
12071948|NCT00064259|Biological|oblimersen sodium|Given IV
12071949|NCT00064259|Drug|cisplatin|Given IV
12071950|NCT00064259|Drug|fluorouracil|Given IV
12071951|NCT00064246|Biological|rituximab|Given IV
12071952|NCT00064246|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
12071953|NCT00064246|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
12071954|NCT00064233|Drug|dasatinib|
12071955|NCT00064220|Drug|soblidotin|
12071956|NCT00064207|Drug|gemcitabine hydrochloride|
12071957|NCT00064207|Procedure|adjuvant therapy|
12071958|NCT00064207|Radiation|radiation therapy|
12071959|NCT00064194|Dietary Supplement|selenium|
12071960|NCT00064194|Dietary Supplement|soy protein isolate|
12071961|NCT00064194|Dietary Supplement|vitamin E|
12071962|NCT00064181|Drug|FOLFIRI regimen|
12071963|NCT00064181|Drug|capecitabine|
12071964|NCT00064181|Drug|celecoxib|
12071965|NCT00064181|Drug|fluorouracil|
12071966|NCT00064181|Drug|irinotecan hydrochloride|
12071967|NCT00064181|Drug|leucovorin calcium|
12071968|NCT00064142|Drug|halofuginone hydrobromide|Applied topically
12071969|NCT00064142|Other|placebo|Applied topically
12071970|NCT00064142|Other|laboratory biomarker analysis|Correlative studies
12071971|NCT00064142|Other|pharmacological study|Correlative studies
12071972|NCT00064129|Biological|Ipilimumab|Given IV
12071973|NCT00064129|Other|Laboratory Biomarker Analysis|Correlative studies
12071974|NCT00064129|Other|Pharmacological Study|Correlative studies
12071975|NCT00064129|Biological|Sargramostim|Given SC
12071976|NCT00064116|Biological|rituximab|Rituximab 375 mg/m² i.v. day 1
12071977|NCT00064116|Drug|CHOP regimen|Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6
12071978|NCT00064103|Biological|Ad5CMV-p53 gene|Given intramucosally or as oral rinse
12071979|NCT00064103|Other|laboratory biomarker analysis|Correlative studies
12071980|NCT00064090|Drug|cytarabine|
12071981|NCT00064090|Drug|triapine|
12071982|NCT00064077|Drug|Cisplatin|Given IV
12071983|NCT00064077|Drug|Gemcitabine Hydrochloride|
12071984|NCT00064077|Drug|Paclitaxel|Given IV
12071985|NCT00064077|Other|Quality-of-Life Assessment|Ancillary studies
12071986|NCT00064077|Drug|Topotecan Hydrochloride|Given IV
12071987|NCT00064077|Drug|Vinorelbine Tartrate|Given IV
12071988|NCT00064064|Drug|gemcitabine hydrochloride|
12071989|NCT00064064|Drug|triapine|
12071990|NCT00064051|Drug|gemcitabine hydrochloride|
12071991|NCT00064051|Drug|triapine|
12071992|NCT00064038|Drug|dexamethasone|Given orally
12071993|NCT00064038|Drug|lenalidomide|Given orally
12071994|NCT00064038|Other|placebo|Given orally
12071995|NCT00064025|Other|Laboratory Biomarker Analysis|Correlative studies
12071996|NCT00064025|Drug|Medroxyprogesterone|Given IM
12072072|NCT00002582|Drug|cyclophosphamide|
12071997|NCT00064025|Procedure|Therapeutic Conventional Surgery|Undergo surgical hysterectomy
12071998|NCT00064012|Drug|bortezomib|
12071999|NCT00064012|Drug|docetaxel|
12072000|NCT00063999|Drug|Carboplatin|Given IV
12072001|NCT00063999|Drug|Cisplatin|Given IV
12072002|NCT00063999|Drug|Doxorubicin Hydrochloride|Given IV
12072003|NCT00063999|Biological|Filgrastim|Given SC
12072004|NCT00063999|Other|Laboratory Biomarker Analysis|Correlative studies
12072005|NCT00063999|Drug|Paclitaxel|Given IV
12072006|NCT00063999|Biological|Pegfilgrastim|Given SC
12072007|NCT00063999|Other|Quality-of-Life Assessment|Ancillary studies
12072008|NCT00063986|Procedure|Minimally invasive esophagectomy (MIE)|Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
12072009|NCT00063973|Drug|cilengitide|Given IV
12072010|NCT00063973|Other|laboratory biomarker analysis|Correlative studies
12072011|NCT00063960|Drug|floxuridine|
12072012|NCT00063960|Drug|irinotecan hydrochloride|
12072013|NCT00063947|Drug|erlotinib hydrochloride|Given orally
12072014|NCT00063947|Drug|gemcitabine hydrochloride|Given IV
12072015|NCT00063947|Radiation|radiation therapy|Undergo radiotherapy
12072016|NCT00063947|Other|laboratory biomarker analysis|Correlative studies
12072017|NCT00063934|Biological|oblimersen sodium|Given IV
12072018|NCT00063934|Drug|doxorubicin hydrochloride|Given IV
12072019|NCT00063934|Drug|docetaxel|Given IV
12072020|NCT00063934|Biological|filgrastim|Given SC
12072021|NCT00063934|Biological|pegfilgrastim|Given SC
12072022|NCT00063934|Procedure|therapeutic conventional surgery|Undergo surgical resection
12072023|NCT00063934|Other|pharmacological study|Optional correlative studies
12072024|NCT00063934|Other|laboratory biomarker analysis|Optional correlative studies
12072025|NCT00063895|Drug|erlotinib hydrochloride|Given PO
12072026|NCT00063895|Other|pharmacological study|Correlative studies
12072027|NCT00063895|Other|pharmacogenomic studies|Correlative studies
12072028|NCT00063895|Other|laboratory biomarker analysis|Correlative studies
12072029|NCT00063882|Radiation|Brachytherapy (100/110)|100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.
12072030|NCT00063882|Radiation|Brachytherapy (125/145)|125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.
12072031|NCT00063882|Radiation|External Beam Radiation Therapy|Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.
12072032|NCT00063869|Drug|Etanercept|
12072033|NCT00023907|Drug|paclitaxel|
12072034|NCT00005940|Radiation|iodine I 131 monoclonal antibody BC8|Given IV
12072035|NCT00005940|Drug|busulfan|Given PO
12072036|NCT00005940|Drug|cyclophosphamide|Given IV
12072037|NCT00005940|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic PBSC or bone marrow transplant
12072038|NCT00005940|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC or bone marrow transplant
12072039|NCT00005940|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC or bone marrow transplant
12072040|NCT00005940|Drug|cyclosporine|Given IV or PO
12072041|NCT00005940|Drug|methotrexate|Given IV
12072042|NCT00005940|Other|laboratory biomarker analysis|Correlative studies
12072043|NCT00003211|Biological|filgrastim|
12072044|NCT00003211|Drug|amifostine trihydrate|
12072045|NCT00003211|Drug|cisplatin|
12072046|NCT00003211|Drug|cyclophosphamide|
12072047|NCT00003211|Drug|vincristine sulfate|
12072048|NCT00003211|Procedure|peripheral blood stem cell transplantation|
12072049|NCT00003211|Radiation|radiation therapy|
12072050|NCT00002878|Drug|dexamethasone|
12072051|NCT00002878|Drug|doxorubicin hydrochloride|
12072052|NCT00002878|Drug|valspodar|
12072053|NCT00002878|Drug|vincristine sulfate|
12072054|NCT00063856|Biological|Wetvax (APSV)|
12072055|NCT00063843|Biological|Recombinant Protective Antigen, Anthrax Vaccine Adsorbed|
12072056|NCT00063830|Drug|Alicaforsen|
12072057|NCT00063817|Drug|Conditioning Regimen|Cyclophosphamide 60 mg per kilogram (kg) of body weight per day intravenously (IV) on days -5 and -4 with respect to transplantation; humanized anti-CD2 monoclonal antibody (MEDI-507) 0.6 mg per kg on days -1, 0, and 1 (after test dose of 0.1 mg per kg on day -2); and cyclosporine A 5 mg per kg IV and thymic irradiation (700 cGy) on day -1. Hemodialysis was performed before and 14 hours after each dose of cyclophosphamide.Kidney transplantation was followed by IV infusion of donor bone marrow. Oral cyclosporine A was administered postoperatively, 8 to 12 mg per kg per day, with target trough blood levels of 250 to 350 ng per milliliter; the dose was tapered and discontinued over a period of several months. Protocol amendment that applied to participant 4 and 5: rituximab, 375 mg per square meter of body-surface area days -7 and -2; and prednisone, 2 mg per kg per day starting on the day of transplantation with tapering over the next 10 days.
12072058|NCT00063804|Drug|Ritonavir|
12072059|NCT00063804|Drug|AMD070|
12072060|NCT00063791|Drug|Bortezomib|
12072061|NCT00063778|Biological|AVX101|Alphavirus replicon particle vaccine expressing HIV Gag antigen
12072062|NCT00063778|Other|placebo|phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose
12072063|NCT00063752|Drug|PI-0824|
12072064|NCT00045357|Biological|therapeutic autologous lymphocytes|
12072065|NCT00042900|Drug|pyroxamide|
12072066|NCT00040820|Drug|oxaliplatin|
12072067|NCT00039169|Drug|ortataxel|
12072068|NCT00036660|Drug|SarCNU|
12072069|NCT00033384|Drug|CI-1040|
12072070|NCT00002752|Radiation|iodine I 131 monoclonal antibody 81C6|
12072071|NCT00002582|Drug|CMF regimen|
12072073|NCT00002582|Drug|doxorubicin hydrochloride|
12072074|NCT00002582|Drug|fluorouracil|
12072075|NCT00002582|Drug|goserelin acetate|
12072076|NCT00002582|Drug|leuprolide acetate|
12072077|NCT00002582|Drug|methotrexate|
12072078|NCT00002582|Drug|tamoxifen citrate|
12072079|NCT00002582|Procedure|oophorectomy|
12072080|NCT00002582|Radiation|radiation therapy|
12072081|NCT00063765|Drug|Ciliary Neurotrophic Factor Implant NT-501|
12072082|NCT00063713|Drug|VELCADE TM (bortezomib) for Injection|
12072083|NCT00063700|Procedure|reducing exposure to marketing pressures|
12072084|NCT00063687|Drug|Oxypurinol|
12072085|NCT00063674|Behavioral|Nutrition Education|
12072086|NCT00063674|Behavioral|After-school dance class|
12072087|NCT00063648|Biological|EBV-specific autologous CTL|
12072088|NCT00063635|Drug|Metformin|500 mg, twice daily
12072089|NCT00063635|Dietary Supplement|Vitamin E|400 IU, twice daily
12072090|NCT00063635|Drug|Matching placebo|Twice daily
12072091|NCT00063622|Drug|Pioglitazone|30 mg daily
12072092|NCT00063622|Dietary Supplement|Vitamin E|800 IU daily
12072093|NCT00063622|Drug|Matching placebo|Daily
12072094|NCT00063609|Drug|zoledronic acid|
12072095|NCT00063596|Drug|Vitamin A supplementation|
12072096|NCT00063583|Drug|Pirfenidone|Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
12072097|NCT00063570|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 14 days, until disease progression
12072098|NCT00063570|Drug|Gemcitabine|1500 mg/m2, intravenous (IV), every 14 days, until disease progression
12072099|NCT00063570|Drug|Gemcitabine|1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression
12072100|NCT00063570|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days, until disease progression
12072101|NCT00063323|Drug|Bupropion|
12072102|NCT00033319|Dietary Supplement|folic acid|
12072103|NCT00033319|Drug|acetylsalicylic acid|
12072104|NCT00031954|Drug|carboplatin|
12072105|NCT00031954|Drug|gemcitabine hydrochloride|
12072106|NCT00031954|Drug|paclitaxel|
12072107|NCT00031889|Drug|Exemestane|Exemestane
12072108|NCT00031889|Drug|Exemestane+bicalutamide|Exemestane as in arm I and oral bicalutamide once daily
12072109|NCT00031668|Radiation|radiation therapy|
12072110|NCT00028938|Biological|epoetin alfa|
12072111|NCT00028938|Drug|carboplatin|
12072112|NCT00028938|Drug|paclitaxel|
12072113|NCT00028938|Radiation|radiation therapy|
12072114|NCT00063479|Drug|Zoledronic Acid|
12072115|NCT00063453|Dietary Supplement|Vitamin E|vitamin E (400 IU/day all rac-α-tocopheryl acetate)
12072116|NCT00063453|Dietary Supplement|Selenium|selenium (200 μg/d L-selenomethionine)
12072117|NCT00063453|Dietary Supplement|Vitamin E placebo|placebo
12072118|NCT00063453|Dietary Supplement|Selenium placebo|placebo
12072119|NCT00028925|Biological|filgrastim|
12072120|NCT00028925|Drug|carboplatin|
12072121|NCT00028925|Drug|topotecan hydrochloride|
12072122|NCT00028925|Radiation|WBRT|
12072123|NCT00028613|Radiation|iodine I 131 monoclonal antibody Lym-1|
12072124|NCT00063427|Drug|MAC-321|
12072125|NCT00063414|Drug|Alicaforsen|
12072126|NCT00063401|Biological|Cetuximab:|400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
12072127|NCT00063401|Drug|Paclitaxel|175 mg/m2 Day 1, six 21-day cycles
12072128|NCT00063401|Drug|Carboplatin|AUC = 6 Day1, six 21-day cycles
12072129|NCT00063388|Biological|Cetuximab|Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
12072130|NCT00063375|Behavioral|Computer Based Cognitive Behavioral Therapy|
12072131|NCT00063362|Drug|Lithium|Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent /L (mEq/L).
12072132|NCT00063362|Drug|Lamotrigine|Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day.
12072133|NCT00063362|Drug|Divalproex|Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
12072134|NCT00063362|Drug|Placebo|Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day.
12072135|NCT00063336|Behavioral|Cognitive Remediation|A computerized cognitive rehabilitation treatment with day-program activities
12072136|NCT00063336|Behavioral|Computer-skills training|A computerized cognitive rehabilitation treatment with day-program activities
12072137|NCT00030446|Drug|carboplatin|
12072138|NCT00030446|Drug|erlotinib hydrochloride|
12072139|NCT00028483|Drug|cBR96-doxorubicin immunoconjugate|
12072140|NCT00028483|Drug|docetaxel|
12072141|NCT00006968|Biological|filgrastim|
12072142|NCT00006968|Drug|cyclosporine|
12072143|NCT00006968|Drug|pentostatin|
12072144|NCT00006968|Procedure|allogeneic bone marrow transplantation|
12072145|NCT00006968|Procedure|peripheral blood stem cell transplantation|
12072146|NCT00003352|Drug|cyclophosphamide|600 mg/m2, IV, every 3 weeks
12072147|NCT00003352|Drug|Taxotere|60 mg/m2, IV, every 3 weeks
12072148|NCT00003352|Drug|Adriamycin|60 mg/m2, IV, every 3 weeks
12072149|NCT00063310|Drug|Leuprolide acetate|
12072150|NCT00063297|Drug|R209130|
12072151|NCT00040729|Genetic|mutation analysis|
12072152|NCT00063284|Device|Magstim Rapid Magnetic Stimulator|
12072153|NCT00063258|Drug|Tarceva (OSI-774)|150 mg/day, starting day 1 and stopping night prior to surgery.
12072154|NCT00063258|Drug|Paclitaxel|Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.
12072155|NCT00063258|Drug|Carboplatin|Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.
12072156|NCT00063219|Drug|MAC-321|
12072157|NCT00063206|Drug|DVS-233 SR|
12072158|NCT00063193|Drug|minocycline|
12072159|NCT00063193|Drug|creatine|
12072160|NCT00063154|Drug|Pertuzumab|Pertuzumab was supplied as a single-use liquid formulation.
12072161|NCT00063141|Drug|cetuximab|Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
12072162|NCT00063141|Drug|Irinotecan|Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
12072163|NCT00063141|Drug|Irinotecan|Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
12072164|NCT00063128|Drug|insulin|"Administer subcutaneous regular human insulin 30 to 60 minutes before meals, or administer insulin lispro within 15 minutes before meals.
~Inject into abdomen only."
12072165|NCT00063128|Drug|human insulin inhalation powder (HIIP)|"Administer HIIP within 15 minutes before meals.
~Administer doses in one-capsule increments equivalent to approximately 2 IU or 6 IU of subcutaneous insulin.
~Target treatment goals during the treatment sequence are the same as for patients using preprandial injectable insulin"
12072166|NCT00030797|Drug|Irinotecan 70 mg/m2|Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29
12072167|NCT00030797|Drug|Irinotecan 240 mg/m2|Irinotecan i.v. 240 mg/m2 day 1 and day 22
12072168|NCT00026520|Biological|recombinant interferon alfa|
12072169|NCT00026520|Drug|thalidomide|
12072170|NCT00026364|Drug|fluorouracil|
12072171|NCT00026364|Drug|gefitinib|
12072172|NCT00026364|Drug|irinotecan hydrochloride|
12072173|NCT00026364|Drug|leucovorin calcium|
12072174|NCT00026351|Biological|rituximab|
12072175|NCT00026351|Drug|pentostatin|
12072176|NCT00025571|Drug|HPPH|
12072177|NCT00006013|Drug|semaxanib|
12072178|NCT00004037|Drug|docetaxel|
12072179|NCT00003054|Drug|paclitaxel|
12072180|NCT00063232|Drug|Metformin|After complete medical evaluation and liver biopsy, patients who qualified for therapy were started on metformin in an initial dose of 500 mg once daily. After 2 weeks, the dose was increased to 500 mg twice daily and after 4 weeks to the full dose of 1000 mg twice daily. Subsequent dose reductions were carried out based on tolerance, with particular attention to gastrointestinal upset and abdominal bloating. Patients were seen in the out-patient clinic, had a brief medical history and examination and routine blood tests at 2 and 4 weeks after enrolment and every 4 weeks thereafter. The oral and intravenous glucose tolerance tests were repeated after 40 and 44 weeks respectively and liver biopsy and imaging tests at 48 weeks. Metformin was discontinued after 48 weeks in patients without diabetes on the pre-treatment evaluation.
12072181|NCT00063102|Drug|ABT-751|
12072182|NCT00063089|Drug|S. aureus Immune Globulin Intravenous (Human) 5%|
12072183|NCT00063076|Drug|Targretin Gel 1%|Alopecia lesions on one-half of the head including facial hair treated, and other half on head serves as control (untreated). Starting dose once every day till Week 3 then escalate to twice a day.
12072184|NCT00063050|Behavioral|Physical activity and nutrition intervention|
12072185|NCT00063037|Behavioral|Behavioral modification - nutrition education|
12072186|NCT00063024|Behavioral|Increased calcium intake|
12072187|NCT00063024|Behavioral|Weight-bearing physical activity|
12072188|NCT00063011|Behavioral|Calcium rich diet|
12072189|NCT00063011|Behavioral|Weight bearing exercise|
12072190|NCT00025545|Drug|cyclophosphamide|
12072191|NCT00025545|Drug|methotrexate|
12072192|NCT00025545|Procedure|peripheral blood stem cell transplantation|
12072193|NCT00025545|Radiation|radiation therapy|
12072194|NCT00024323|Drug|cisplatin|
12072195|NCT00024323|Drug|triapine|
12072196|NCT00024310|Dietary Supplement|folic acid|
12072197|NCT00024310|Drug|lometrexol|
12072198|NCT00024310|Drug|paclitaxel|
12072199|NCT00024141|Drug|fluorouracil|
12072200|NCT00024141|Drug|irinotecan hydrochloride|
12072201|NCT00023933|Drug|iodine I 131 monoclonal antibody CC49-deltaCH2|Given IV
12072202|NCT00062985|Behavioral|Mail-based weight loss intervention|
12072203|NCT00062985|Behavioral|Phone-based weight loss intervention|
12072204|NCT00062972|Drug|donepezil|
12072205|NCT00062972|Drug|glucose|
12072206|NCT00062959|Behavioral|Going Places: School program to prevent problem behavior|
12072207|NCT00062907|Biological|Recombinant DNA- pVAX/L523S|
12072208|NCT00062907|Biological|Recombinant adenovirus- Ad/L523S|
12072209|NCT00062894|Drug|Iodine I 131 Tositumomab|
12072210|NCT00062946|Drug|(18F)fallypride|
12072211|NCT00062933|Procedure|Laparotomy|
12072212|NCT00062881|Drug|Intrathecal Mafosfamide|
12072213|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Group A)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
12072214|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Group B)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
12072277|NCT00062621|Procedure|Combined bone marrow and kidney transplant|
12072278|NCT00062608|Behavioral|Written self-disclosure|
12072215|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Group C)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
12072216|NCT00062868|Biological|LMP2 CTLs (ALSCER - Group A)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
12072217|NCT00062868|Biological|LMP2 CTLs (ALSCER - Group B)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
12072218|NCT00062868|Biological|LMP2 CTLs (ALSCER - Group C)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
12072219|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Expansion - Group A)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2"
12072220|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Expansion Group B)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2"
12072221|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Expansion Group C)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2"
12072222|NCT00062855|Procedure|Skin Biopsy|
12072223|NCT00062855|Genetic|Gene Modified Neuroblastoma Cells|"The first two injections will be given at week 1 and week 2 (i.e., separated by one week). Patients will then have a two-week rest and the remaining two injections will be given (again separated by one week) at week 4 and week 5.
~A complete evaluation for evidence of toxicity and response will be performed at week 8 (after a 3 week rest).
~At the 8 week (month 2) evaluation, in the absence of progressive disease requiring therapy without excessive toxicity and if more transduced cells are available, the patient will have the option to receive four additional SC injections each separated by 1 month at the higher of the two dosage levels they originally received."
12072224|NCT00062842|Drug|Irinotecan|
12072225|NCT00062829|Behavioral|Teen Driving: Program for parents|A behavioral intervention targeting driving risks unique to young drivers, including completing a behavioral contract, was administered to the intervention group. The control group received safety information appropriate for new drivers.
12072226|NCT00062816|Drug|ISIS 14803, peginterferon alfa, ribavirin|
12072227|NCT00002643|Biological|filgrastim|
12072228|NCT00002643|Drug|amifostine trihydrate|
12072229|NCT00002643|Drug|cyclophosphamide|
12072230|NCT00002643|Drug|doxorubicin hydrochloride|
12072231|NCT00002643|Drug|etoposide|
12072232|NCT00002643|Drug|ifosfamide|
12072233|NCT00002643|Drug|topotecan hydrochloride|
12072234|NCT00002643|Drug|vincristine sulfate|
12072235|NCT00002643|Procedure|conventional surgery|
12072236|NCT00002643|Radiation|low-LET cobalt-60 gamma ray therapy|
12072237|NCT00002643|Radiation|low-LET electron therapy|
12072238|NCT00002643|Radiation|low-LET photon therapy|
12072239|NCT00062803|Drug|SR34006|
12072240|NCT00062803|Drug|(LMW)heparin|
12072241|NCT00062803|Drug|Warfarin VKA|
12072242|NCT00062803|Drug|Acenocoumarol VKA|
12072243|NCT00062790|Drug|Dutasteride|
12072244|NCT00027612|Drug|carmustine|IV
12072245|NCT00027612|Drug|irinotecan hydrochloride|IV
12072246|NCT00027612|Radiation|radiation therapy|
12072247|NCT00025376|Drug|PS-341|
12072248|NCT00025376|Procedure|Tumor Biopsy|
12072249|NCT00023868|Drug|FOLFIRI regimen|
12072250|NCT00023868|Drug|cisplatin|
12072251|NCT00023868|Drug|doxorubicin hydrochloride|
12072252|NCT00023868|Drug|fluorouracil|
12072253|NCT00023868|Drug|irinotecan hydrochloride|
12072254|NCT00023868|Drug|leucovorin calcium|
12072255|NCT00023868|Drug|mitomycin C|
12072256|NCT00022594|Drug|liposomal lurtotecan|
12072257|NCT00022529|Drug|BMS-214662|Given IV
12072258|NCT00022529|Biological|trastuzumab|Given IV
12072259|NCT00022529|Other|pharmacological study|Correlative studies
12072260|NCT00062764|Drug|Actos (Pioglitazone)|Pts receive drug in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum ALT levels do not fall to normal by the 1 year pt; if pts have a biochemical response, drug is continued for 3 years,
12072261|NCT00062751|Drug|Letrozole / Temsirolimus (CCI-779)|Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily
12072262|NCT00062751|Drug|Letrozole / Temsirolimus (CCI-779)|Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks
12072263|NCT00062751|Drug|Letrozole|Letrozole 2.5 mg daily
12072264|NCT00062738|Drug|paroxetine|Paroxetine CR 12.5 - 25 mg q hs
12072265|NCT00062738|Drug|Nortriptyline|nortriptyline 25 - 75 mg q hs
12072266|NCT00062738|Other|placebo|matching placebo
12072267|NCT00062699|Drug|Zemplar (paricalcitol injection)|
12072268|NCT00062699|Drug|Calcijex|
12072269|NCT00062712|Drug|Allogeneic Bone Marrow, Anti-Thymocyte Globulin (Sangstat) & Sirolimus (Wyeth-Ay|
12072270|NCT00062686|Drug|GW572016|
12072271|NCT00062673|Drug|Duloxetine|
12072272|NCT00062673|Drug|Placebo|
12072273|NCT00062660|Drug|Tipranavir|Tipranavir 250 mg soft elastic capsules
12072274|NCT00062647|Drug|Telavancin|Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
12072275|NCT00062647|Drug|Vancomycin, nafcillin, oxacillin, or cloxacillin|Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.
12072276|NCT00062634|Behavioral|Female condom skills training|
12072279|NCT00062595|Drug|phylloquinone (K1)|
12072280|NCT00062595|Drug|menatetranone (MK4)|
12072281|NCT00062569|Behavioral|Bathing Support Intervention (BSI)|Bathing Support Intervention - Review of caregiver current practices and perceptions and care recipient behavioral symptoms associated with bathing with pattern analysis based on observation; skill building for bathing and communication techniques; coaching for implementation
12072282|NCT00062569|Behavioral|Caregiver reminiscence with coaching|"BSI plus Reminiscence - BSI as above plus caregiver interview to ascertain pleasant long-term memories (e.g. stories, pictures, music) developed into a crib sheet for caregiver use conversationally prior to and during the bath"
12072283|NCT00062556|Drug|Niacin Extended Release and Lovastatin Tablets|
12072284|NCT00062543|Procedure|Hepatic artery infusion of CD34+ cells|Donor's cells infused directly into liver through a groin catheter (hepatic artery).
12072285|NCT00062543|Device|Cobe Spectra|Mononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra).
12072286|NCT00062530|Biological|SCBaL/M9|Oral recombinant Salmonella typhi HIV-1 gp120 vaccine
12072287|NCT00062504|Drug|Talampanel|10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks
12072288|NCT00062491|Drug|Karenitecin (BNP1350)|Karenitecn (1.0 mg/m2) administered as a single daily 60-minute intravenous infusion for 5 consecutive days repeated every 21 days (1 treatment cycle). Patients who respond (CR< PR, SD) can continue treatment for 6 cycles, unless unacceptable toxicity develops. Treatment will be discontinued if progressive disease or unacceptable toxicity develops.
12072289|NCT00062478|Drug|Karenitecin (BNP1350)|Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity.
12072290|NCT00022009|Drug|gemcitabine hydrochloride|
12072291|NCT00018954|Drug|asparaginase|
12072292|NCT00018954|Drug|cyclophosphamide|
12072293|NCT00018954|Drug|cytarabine|
12072294|NCT00018954|Drug|daunorubicin hydrochloride|
12072295|NCT00018954|Drug|doxorubicin hydrochloride|
12072296|NCT00018954|Drug|etoposide|
12072297|NCT00018954|Drug|ifosfamide|
12072298|NCT00018954|Drug|mercaptopurine|
12072299|NCT00018954|Drug|methotrexate|
12072300|NCT00018954|Drug|prednisone|
12072301|NCT00018954|Drug|vincristine sulfate|
12072302|NCT00018954|Procedure|conventional surgery|
12072303|NCT00018954|Radiation|radiation therapy|
12072304|NCT00017446|Drug|CP4071|
12072305|NCT00017394|Biological|bevacizumab|Given IV
12072306|NCT00017394|Drug|vinorelbine tartrate|Given IV
12072307|NCT00017394|Other|laboratory biomarker analysis|Correlative studies
12072308|NCT00017316|Drug|semaxanib|
12072309|NCT00017316|Drug|thalidomide|
12072310|NCT00062582|Drug|Roflumilast|
12072311|NCT00016107|Drug|estramustine phosphate sodium|Given orally
12072312|NCT00016107|Drug|docetaxel|Given IV
12072313|NCT00016107|Biological|bevacizumab|Given IV
12072314|NCT00016107|Other|laboratory biomarker analysis|Correlative studies
12072315|NCT00014664|Biological|apolizumab|
12072316|NCT00014534|Biological|filgrastim|6 mg sub Q
12072317|NCT00014534|Drug|cisplatin|60 mg/sq m IV
12072318|NCT00014534|Drug|doxorubicin hydrochloride|50 mg/ sq m IV
12072319|NCT00014534|Drug|gemcitabine hydrochloride|1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm
12072320|NCT00014170|Drug|gefitinib|Given orally
12072321|NCT00014170|Other|pharmacological study|Correlative studies
12072322|NCT00014170|Other|laboratory biomarker analysis|Correlative studies
12072323|NCT00014170|Other|questionnaire administration|Ancillary studies
12072324|NCT00014170|Procedure|quality-of-life assessment|Ancillary studies
12072325|NCT00012155|Biological|NV1020|
12072326|NCT00062465|Drug|TwHF|
12072327|NCT00062439|Drug|cisplatin|During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes
12072328|NCT00062439|Drug|docetaxel|During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
12072329|NCT00062439|Drug|etoposide|During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.
12072330|NCT00062439|Procedure|conventional surgery|If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy.
12072331|NCT00062439|Radiation|radiation therapy|Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter.
12072332|NCT00062426|Biological|bevacizumab|
12072333|NCT00062426|Drug|capecitabine|
12072334|NCT00062426|Drug|fluorouracil|
12072335|NCT00062426|Drug|leucovorin calcium|
12072336|NCT00062426|Drug|oxaliplatin|
12072337|NCT00062400|Procedure|psychosocial assessment and care|
12072338|NCT00062387|Drug|perifosine|
12072339|NCT00062374|Drug|Cisplatin|Given IV
12072340|NCT00062374|Procedure|Computed Tomography|Undergo FDG and FLT PET/CT
12072341|NCT00062374|Radiation|Fludeoxyglucose F-18|Undergo FDG-PET/CT
12072342|NCT00062374|Other|Fluorothymidine F-18|Undergo FLT-PET/CT
12072343|NCT00062374|Drug|Irinotecan Hydrochloride|Given IV
12072344|NCT00062374|Procedure|Positron Emission Tomography|Undergo FDG and FLT PET/CT
12072345|NCT00062374|Procedure|Therapeutic Conventional Surgery|Undergo radical subtotal or total gastrectomy with lymph node dissection
12072346|NCT00062348|Drug|boronophenylalanine-fructose complex|
12072347|NCT00062348|Drug|sodium borocaptate|
12072348|NCT00062348|Procedure|conventional surgery|
12072349|NCT00062335|Radiation|radiation therapy|
12072350|NCT00062322|Drug|cisplatin|
12072351|NCT00062322|Drug|irinotecan hydrochloride|
12072352|NCT00062322|Procedure|conventional surgery|
12072353|NCT00062322|Procedure|neoadjuvant therapy|
12072354|NCT00062322|Radiation|radiation therapy|
12072355|NCT00062309|Radiation|radiation therapy|
12072356|NCT00062296|Biological|rituximab|
12072357|NCT00062296|Drug|epirubicin hydrochloride|
12072358|NCT00062283|Drug|L-alanosine|
12072359|NCT00062270|Drug|cisplatin|
12072360|NCT00062270|Drug|docetaxel|
12072361|NCT00062270|Drug|gefitinib|
12072362|NCT00062270|Drug|gemcitabine hydrochloride|
12072363|NCT00062270|Procedure|conventional surgery|
12072364|NCT00062270|Procedure|neoadjuvant therapy|
12072365|NCT00062270|Radiation|radiation therapy|
12072366|NCT00062257|Drug|irofulven|
12072367|NCT00062244|Biological|oblimersen sodium|Given IV
12072368|NCT00062231|Drug|amoxicillin-clavulanate potassium|
12072369|NCT00062231|Drug|ciprofloxacin|
12072370|NCT00062231|Drug|moxifloxacin hydrochloride|
12072371|NCT00062231|Procedure|management of therapy complications|
12072372|NCT00062205|Drug|imatinib mesylate|
12072373|NCT00062179|Drug|carboplatin|Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
12072374|NCT00062179|Drug|celecoxib|Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
12072375|NCT00062179|Drug|paclitaxel|Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
12072376|NCT00062179|Other|Placebo|placebo 3-7 days before first dose of chemotherapy
12072377|NCT00062140|Drug|cyclophosphamide|
12072378|NCT00062140|Procedure|allogeneic bone marrow transplantation|
12072379|NCT00062140|Procedure|peripheral blood stem cell transplantation|
12072380|NCT00062140|Radiation|radiation therapy|
12072381|NCT00062127|Drug|irinotecan hydrochloride|Given IV
12072382|NCT00062127|Drug|thalidomide|Given orally
12072383|NCT00062127|Other|pharmacological study|Correlative studies
12072384|NCT00062114|Biological|rituximab|
12072385|NCT00062114|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12072386|NCT00062101|Drug|erlotinib hydrochloride|Given orally (PO)
12072387|NCT00062101|Drug|celecoxib|Given PO
12072388|NCT00062101|Other|laboratory biomarker analysis|Correlative studies
12072389|NCT00062075|Drug|romidepsin|Given IV
12072390|NCT00062062|Drug|carboplatin|
12072391|NCT00062062|Drug|gefitinib|
12072392|NCT00062062|Drug|paclitaxel|
12072393|NCT00062049|Biological|recombinant interleukin-7|
12072394|NCT00062036|Biological|aldesleukin|
12072395|NCT00062036|Biological|filgrastim|
12072396|NCT00062036|Biological|incomplete Freund's adjuvant|
12072397|NCT00062036|Biological|interleukin-2 gene|
12072398|NCT00062036|Biological|therapeutic tumor infiltrating lymphocytes|
12072399|NCT00062036|Drug|cyclophosphamide|
12072400|NCT00062036|Drug|fludarabine phosphate|
12072401|NCT00062023|Drug|Acetylsalicylic acid (Aspirin)|Patients receive oral aspirin once daily for 12 months.
12072402|NCT00062023|Drug|Sulindac|Patients receive oral sulindac twice daily for 12 months.
12072403|NCT00062023|Drug|Ursodiol|Patients receive oral ursodiol three times daily for 12 months.
12072404|NCT00062023|Other|Sulindac Placebo|Oral sulindac placebo twice daily.
12072405|NCT00062010|Biological|interferon alpha|Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
12072406|NCT00062010|Drug|13-cis-retinoic acid|13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
12072407|NCT00062010|Drug|paclitaxel|paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
12072408|NCT00061997|Dietary Supplement|inositol|
12072409|NCT00061984|Biological|pegfilgrastim|
12072410|NCT00061984|Drug|doxorubicin hydrochloride|
12072411|NCT00061984|Drug|ifosfamide|
12072412|NCT00061984|Procedure|multimodality therapy|
12072413|NCT00061958|Drug|arsenic trioxide|Given IV
12072414|NCT00061945|Drug|allopurinol|Given PO
12072415|NCT00061945|Drug|cyclophosphamide|Given IV
12072416|NCT00061945|Drug|daunorubicin hydrochloride|Given IV
12072417|NCT00061945|Drug|vincristine sulfate|Given IV
12072418|NCT00061945|Drug|dexamethasone|Given PO and as eye drops
12072419|NCT00061945|Drug|asparaginase|Given SC
12072420|NCT00061945|Biological|filgrastim|Given SC
12072421|NCT00061945|Drug|imatinib mesylate|Given PO
12072422|NCT00061945|Drug|methotrexate|Given IT, IV, and PO
12072423|NCT00061945|Drug|cytarabine|Given IV
12072424|NCT00061945|Drug|trimethoprim-sulfamethoxazole|Given PO
12072425|NCT00061945|Drug|mercaptopurine|Given PO
12072426|NCT00061945|Drug|leucovorin calcium|Given IV and PO
12072427|NCT00061945|Biological|alemtuzumab|Given SC
12072428|NCT00061945|Drug|acyclovir|Given PO
12072429|NCT00061945|Other|laboratory biomarker analysis|Correlative studies
12072430|NCT00061945|Other|pharmacological study|Correlative studies
12072431|NCT00061932|Drug|bortezomib|Given IV
12072432|NCT00061932|Drug|irinotecan|Given IV
12072433|NCT00061919|Drug|Carboplatin, etoposide & thalidomide|Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.
12072434|NCT00061919|Drug|Carboplatin, etoposide & placebo|Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.
12072644|NCT00005868|Drug|docetaxel|
12072435|NCT00061906|Drug|celecoxib|Treatment will be administered on an outpatient basis. Oral celecoxib will be given at the dose of 400 mg BID for total of 12 months. Patients will be advised to take this medication with food to improve absorption.
12072436|NCT00061893|Drug|celecoxib|Given orally, Celecoxib 250 mg/m2 PO BID (500mg/m2/day) from Day 1 of Cycle 1 through Day 21 of Cycle 14. The dose should be rounded off to the nearest 100 mg. If PK studies are being done, Celecoxib should be given 24 hours prior to the other drugs for Cycle 1 only. [Celecoxib may be interrupted for up to 7 days around the time of surgical procedures.] .
12072437|NCT00061893|Drug|cyclophosphamide|Given IV, 1200 mg/m2 IV infusion over 1 hour with MESNA uroprotection, on Day 1. For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
12072438|NCT00061893|Drug|doxorubicin hydrochloride|Given IV, Doxorubicin 75 mg/ m2 /course continuous IV infusion over 48 hours, beginning Day 1. Note: The total doxorubicin dose per cycle is 75 mg/ m2, which will be given as 37.5 mg/m2/day x 2 days. Doxorubicin may be given as a continuous infusion or brief infusion.
12072439|NCT00061893|Drug|etoposide|Given IV, Vincristine 2 mg/m2 IV push, on Day 1. Maximum dose 2 mg. For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
12072440|NCT00061893|Drug|ifosfamide|Given IV,Ifosfamide 1800 mg/m2 /day IV infusion over 1 hour, Days 1-5 of each cycle. (9,000 mg/m2 max total dose per cycle). Prehydrate for 6 hours, 1,000 ml/m2 total volume (165 ml/m2/hour for 6 hours). For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
12072441|NCT00061893|Drug|vinblastine sulfate|Given IV, Vinblastine 1 mg/m2/d IV push three times per week beginning Day 1 of Cycle 1 and continuing through Day 21 of Cycle 14. In weeks during which vincristine is given, hold one dose of vinblastine and administer only 2 doses of vinblastine during that week. If vinblastine is due the same day as vincristine, hold that dose of vinblastine. [Vinblastine may be interrupted for up to 7 days around the time of surgical procedures.]
12072442|NCT00061893|Drug|vincristine sulfate|Given IV, Vincristine 2 mg/m2 IV push, on Day 1. Maximum dose 2 mg. For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
12072443|NCT00061893|Procedure|conventional surgery|Patients who respond to induction chemotherapy undergo surgery on week 13. Patients who have inadequate margins after surgery undergo radiotherapy beginning on week 15. (see Detailed Description for frequency of administration and groups evaluated)
12072444|NCT00061893|Radiation|radiation therapy|Patients with unresectable lesions undergo radiotherapy 5 days a week for approximately 6 weeks beginning on week 13. (see Detailed Description for frequency of administration and groups evaluated)
12072445|NCT00061893|Drug|MESNA|The total daily MESNA dose is equal to at least 60% of the daily cyclophosphamide or ifosfamide dose, or by continuous infusion of the 60% dose. MESNA continuous infusion should be started at the same time as the cyclophosphamide/ifosfamide and be completed no sooner than 8 hours after the end of the cyclophosphamide or ifosfamide infusion. The oral dose of MESNA is 2x the IV dose. Patients able to tolerate oral MESNA may receive the final dose by mouth at 40% of the oxazaphosphorine (cyclophosphamide or ifosfamide) dose. The dose should be given two hours earlier than the IV dose would be given. Additionally, if the patient vomits within two hours after the oral dose, the dose should be repeated or IV MESNA given.
12072446|NCT00061893|Drug|Filgrastim|G-CSF (Filgrastim) 5 micrograms/kg/day subcutaneously beginning 24 to 48 hours after the last dose of chemotherapy, and continuing until the absolute neutrophil count is 2,000/µL or greater after nadir.
12072447|NCT00061880|Drug|forodesine hydrochloride|
12072448|NCT00061867|Drug|pegylated liposomal doxorubicin hydrochloride|
12072449|NCT00061867|Procedure|hyperthermia treatment|
12072450|NCT00061854|Drug|soblidotin|
12072451|NCT00061841|Behavioral|exercise|
12072452|NCT00061815|Biological|cetuximab|400 mg/m2 IV
12072453|NCT00061815|Drug|oxaliplatin|85 mg/m2 IV
12072454|NCT00061815|Drug|leucovorin|200 mg/m2 IV
12072455|NCT00061815|Drug|5-fluorouracil|400 mg/m2 IV
12072456|NCT00061815|Drug|5-fluorouracil|600 mg/m2 IV
12072457|NCT00061815|Biological|cetuximab|250 mg/m2 IV
12072458|NCT00033462|Drug|erlotinib hydrochloride|Given orally
12072459|NCT00033462|Other|laboratory biomarker analysis|Correlative studies
12072460|NCT00010231|Dietary Supplement|calcitriol|
12072461|NCT00010231|Drug|dexamethasone|
12072462|NCT00009932|Drug|cisplatin|
12072463|NCT00009932|Drug|fenretinide|
12072464|NCT00009932|Drug|paclitaxel|
12072465|NCT00009802|Dietary Supplement|calcitriol|
12072466|NCT00009802|Drug|paclitaxel|
12072467|NCT00061802|Drug|risperidone, quetiapine|
12072468|NCT00009789|Radiation|accelerated conformational radiotherapy|
12072469|NCT00008424|Drug|irinotecan hydrochloride|
12072470|NCT00008398|Biological|sargramostim|
12072471|NCT00008398|Procedure|quality-of-life assessment|
12072472|NCT00008398|Radiation|radiation therapy|
12072473|NCT00008203|Biological|aldesleukin|
12072474|NCT00008203|Biological|recombinant interferon gamma|
12072475|NCT00008203|Drug|carboplatin|
12072476|NCT00008203|Drug|cyclophosphamide|
12072477|NCT00008203|Drug|cyclosporine|
12072478|NCT00008203|Drug|thiotepa|
12072479|NCT00008203|Procedure|autologous bone marrow transplantation|
12072480|NCT00008203|Procedure|peripheral blood stem cell transplantation|
12072481|NCT00008112|Drug|cisplatin|
12072482|NCT00008112|Procedure|hyperthermia treatment|
12072483|NCT00008112|Radiation|brachytherapy|
12072484|NCT00008112|Radiation|radiation therapy|
12072485|NCT00061789|Drug|SPECT Imaging of Nicotinic Acetylcholine Receptors in Brain|
12072486|NCT00061776|Drug|Capsaicin Dermal Patch|
12072487|NCT00061763|Drug|Deferasirox|
12072488|NCT00061750|Drug|ICL670|
12072489|NCT00061750|Drug|deferoxamine|
12072490|NCT00061711|Drug|Hormone Replacement Therapy|
12072491|NCT00061711|Drug|Cimicifuga racemosa (Black Cohosh)|
12072492|NCT00061711|Drug|Multibotanical phytoestrogen formula|
12072493|NCT00061698|Behavioral|Cognitive Behavior Therapy Child Only|Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
12072494|NCT00061698|Behavioral|CBT plus Parent Training|Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. Parents learned skills that helped their child to apply the strategies they learned. Parents learned how to better communicate positive information that helped their child build a positive core belief. Parents learned how to use reinforcement to support healthy behavior.
12072495|NCT00061672|Drug|ABT-510 - Thrombospondin-1 Mimetic|
12072496|NCT00061659|Drug|ABT-510 - Thrombospondin-1 mimetic|
12072497|NCT00061646|Drug|ABT-510/Thrombospondin-1 mimetic|
12072498|NCT00061646|Drug|Carboplatin/Taxol|
12072499|NCT00051714|Behavioral|Family-Based Preventive Intervention|
12072500|NCT00061633|Drug|Telavancin|Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
12072501|NCT00061633|Drug|Vancomycin or antistaphylococcal penicillin|Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
12072502|NCT00061620|Drug|Tezacitabine (FMdC)|7.5 mg/m2 bolus infusion daily x 5
12072503|NCT00059462|Drug|Interleukin-2 SA|HAART and Bay 50-4798
12072504|NCT00059462|Drug|HAART|HAART alone
12072505|NCT00008021|Biological|filgrastim|
12072506|NCT00008021|Biological|monoclonal antibody Lym-1|
12072507|NCT00008021|Drug|cyclosporine|
12072508|NCT00008021|Drug|paclitaxel|
12072509|NCT00008021|Procedure|peripheral blood stem cell transplantation|
12072510|NCT00008021|Radiation|indium In 111 monoclonal antibody Lym-1|
12072511|NCT00008021|Radiation|yttrium Y 90 monoclonal antibody Lym-1|
12072512|NCT00006864|Biological|aldesleukin|
12072513|NCT00006484|Drug|carboplatin|
12072514|NCT00006484|Drug|paclitaxel|
12072515|NCT00006484|Drug|tirapazamine|
12072516|NCT00061594|Drug|rhuFab V2 (ranibizumab)|
12072517|NCT00061542|Drug|BETOPTIC S (betaxolol HCl)|betaxolol HC)
12072518|NCT00061542|Drug|Timolol Gel-forming Solution (TGFS)|timolol maleate 0.25% and 0.5%
12072519|NCT00061529|Drug|Brimonidine Tartrate Ophthalmic Solution|
12072520|NCT00061516|Drug|BETAXON (levobetaxolol HCl)|levobetaxolol suspension, 0.5%
12072521|NCT00061516|Drug|AZOPT (brinzolamide)|brinzolamide suspension, 1%
12072522|NCT00061503|Drug|Travoprost|
12072523|NCT00006464|Drug|7-hydroxystaurosporine|
12072524|NCT00006464|Drug|cisplatin|
12072525|NCT00006457|Drug|oltipraz|
12072526|NCT00006383|Drug|liposomal vincristine sulfate|
12072527|NCT00006377|Drug|carboplatin|
12072528|NCT00006377|Drug|doxorubicin hydrochloride|
12072529|NCT00006377|Drug|paclitaxel|
12072530|NCT00006361|Drug|semaxanib|
12072531|NCT00061581|Device|Isolex 300i Stem Cell Selection|
12072532|NCT00061568|Procedure|Peripheral blood hematopoietic progenitor cell (PBPC) transplant|Peripheral blood hematopoietic progenitor cell (PBPC) transplant
12072533|NCT00061568|Drug|Alemtuzumab|Alemtuzumab
12072534|NCT00061568|Procedure|Peripheral blood hematopoietic progenitor cell Apherisis|Donor-Peripheral blood hematopoietic progenitor cell (PBPC) apheresis
12072535|NCT00061568|Drug|Sirolimus|Sirolimus
12072536|NCT00061490|Behavioral|Behavioral weight control and lifestyle exercise|16 weekly educational meetings vs. waitlist control
12072537|NCT00061477|Drug|Pemetrexed|
12072538|NCT00061477|Drug|Gemcitabine|
12072539|NCT00061464|Drug|pemetrexed|
12072540|NCT00061464|Drug|gemcitabine|
12072541|NCT00061451|Drug|Pemetrexed|
12072542|NCT00061451|Drug|Gemcitabine|
12072543|NCT00006349|Dietary Supplement|vitamin E|
12072544|NCT00006349|Drug|donepezil hydrochloride|
12072545|NCT00006349|Other|placebo|
12072546|NCT00006341|Other|Implant|A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.
12072547|NCT00061438|Drug|meropenem|
12072548|NCT00061425|Drug|radiolabeled epratuzumab|
12072549|NCT00061412|Behavioral|Comprehensive program to improve reading and writing skills|
12072550|NCT00061386|Behavioral|Nutrition and physical activity program|
12072551|NCT00061321|Drug|Nevirapine and mulitvitamins|Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
12072552|NCT00061308|Drug|Topotecan|
12072553|NCT00061308|Drug|Gemcitabine|
12072554|NCT00061295|Procedure|Body weight support treadmill training|
12072555|NCT00045149|Biological|aldesleukin|
12072556|NCT00045149|Biological|therapeutic tumor infiltrating lymphocytes|
12072557|NCT00019734|Biological|aldesleukin|
12072558|NCT00019734|Biological|fowlpox virus vaccine vector|
12072559|NCT00019734|Biological|vaccinia-tyrosinase vaccine|
12072645|NCT00060996|Drug|Remodulin® (treprostinil sodium) Injection|
12072646|NCT00005813|Biological|bispecific antibody MDX447|
12072560|NCT00061373|Drug|Aspirin|A single 81 mg aspirin tablet orally (or rectal suppository equivalent dose) given as soon as possible after start of standard iv tPA and consent.
12072561|NCT00061373|Drug|tinzaparin sodium|A single weight-based dose of 80 anti-Xa International Units/kilogram (IU/kg)administered by subcutaneous (SQ) injection.
12072562|NCT00061373|Drug|eptifibatide|Eptifibatide administered iv according to dose escalation group. The five dosing groups for eptifibatide are 0, 45 µg/kg bolus, 90 µg/kg bolus, 90 µg/kg bolus plus 0.25 µg/kg/min infusion for 24 hours, and 90 µg/kg bolus plus 0.5 µg/kg/min infusion for 24 hours.
12072563|NCT00061360|Drug|ATG+Rapamune+cyclosporine|ATG+Rapamune+cyclosporine
12072564|NCT00061360|Drug|ATG+cyclosporine|ATG+cyclosporine
12072565|NCT00061347|Procedure|Fiducial marker placement|Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
12072566|NCT00061282|Drug|Clotrimazole|One retention enema, administered nightly
12072567|NCT00041353|Other|cytology specimen collection procedure|
12072568|NCT00041353|Procedure|comparison of screening methods|
12072569|NCT00041353|Procedure|study of high risk factors|
12072570|NCT00019175|Biological|aldesleukin|
12072571|NCT00019175|Biological|fowlpox virus vaccine vector|
12072572|NCT00019175|Biological|gp100 antigen|
12072573|NCT00002786|Biological|aldesleukin|
12072574|NCT00002786|Biological|therapeutic tumor infiltrating lymphocytes|
12072575|NCT00061269|Procedure|Videoscopic-Assisted Retroperitoneal Debridement (VARD)|
12072576|NCT00061256|Drug|Alendronate|
12072577|NCT00061256|Drug|Calcium carbonate|
12072578|NCT00061256|Drug|Vitamin D|
12072579|NCT00061243|Biological|HIV-1 DNA vaccine with protein vaccine boost|Three doses of DNA vaccination will be administered at weeks 0, 4, and 12, and 2 doses of protein vaccination at weeks 20 and 28
12072580|NCT00061230|Behavioral|biofeedback-monitored relaxation training|
12072581|NCT00061217|Device|Unrectified prosthetic socket|
12072582|NCT00061217|Device|Rectified prosthetic socket|
12072583|NCT00061178|Drug|rhuMAb VEGF (Bevacizumab)|
12072584|NCT00061165|Behavioral|School + family changes promoting healthy eating + activity|
12072585|NCT00019084|Biological|aldesleukin|
12072586|NCT00019084|Biological|mutant p53 peptide pulsed dendritic cell vaccine|
12072587|NCT00019084|Biological|ras peptide cancer vaccine|
12072588|NCT00019084|Biological|sargramostim|
12072589|NCT00019084|Biological|therapeutic autologous lymphocytes|
12072590|NCT00019084|Biological|therapeutic tumor infiltrating lymphocytes|
12072591|NCT00015821|Drug|thalidomide|Given PO
12072592|NCT00015821|Other|laboratory biomarker analysis|Correlative studies
12072593|NCT00004868|Drug|semaxanib|
12072594|NCT00003408|Biological|aldesleukin|
12072595|NCT00003408|Biological|recombinant interferon alfa|
12072596|NCT00003408|Biological|sargramostim|
12072597|NCT00061152|Drug|Capsaicin Dermal Patch|
12072598|NCT00061139|Behavioral|Pediatric Constraint-Induced Movement therapy|
12072599|NCT00061139|Behavioral|Conventional pediatric motor rehabilitation therapy|
12072600|NCT00061126|Drug|ABX-EGF|
12072601|NCT00061113|Drug|Fluoxetine + outpatient cognitive behavioral therapy|single fixed morning dose 20 mg X 15 weeks
12072602|NCT00061113|Drug|fluoxetine|20mg, QD x 16 weeks
12072603|NCT00061113|Drug|placebo + CBT|single fixed morning dose X 16 weeks
12072604|NCT00061100|Behavioral|Behavior Therapy-RISE|manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
12072605|NCT00061100|Behavioral|Standard prevention Education|standard psychosocial Education for HIV/hepatitis prevention
12072606|NCT00061087|Drug|Methylphenidate|Methylphenidate 80mg/day
12072607|NCT00061087|Drug|Bupropion|Bupropion 400mg/day
12072608|NCT00061087|Other|Placebo|Placebo
12072609|NCT00061074|Drug|Nicotrol|
12072610|NCT00061061|Behavioral|Behavior Therapy|
12072611|NCT00061035|Biological|Transgenic Lymphocyte Immunization Vaccine (TLI)|
12072612|NCT00006243|Biological|tyrosinase peptide|Given SC
12072613|NCT00006243|Biological|MART-1:27-35 peptide vaccine|Given SC
12072614|NCT00006243|Biological|gp100 antigen|Given SC
12072615|NCT00006243|Biological|incomplete Freund's adjuvant|Given SC
12072616|NCT00006243|Biological|sargramostim|Given SC
12072617|NCT00006243|Other|laboratory biomarker analysis|Correlative studies
12072618|NCT00006242|Drug|BMS-214662|Given IV
12072619|NCT00006242|Other|laboratory biomarker analysis|Correlative studies
12072620|NCT00006242|Other|pharmacological study|Correlative studies
12072621|NCT00006095|Drug|irinotecan hydrochloride|
12072622|NCT00006095|Drug|vincristine sulfate|
12072623|NCT00006086|Drug|BMS-188797|
12072624|NCT00006086|Drug|carboplatin|
12072625|NCT00006082|Drug|rubitecan|
12072626|NCT00061048|Biological|Alemtuzumab|Infusion of Campath-1H 3 mg on day # 1, 10 mg on day #2, and 30 mg day # 3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
12072627|NCT00061022|Drug|NXY-059|
12072628|NCT00006046|Biological|monoclonal antibody Hu3S193|
12072629|NCT00005999|Drug|arsenic trioxide|
12072630|NCT00005977|Biological|filgrastim|Given IV
12072631|NCT00005977|Drug|cyclophosphamide|Given IV
12072632|NCT00005977|Drug|cytarabine|Given IV
12072633|NCT00005977|Drug|dexamethasone|Given IV
12072634|NCT00005977|Drug|doxorubicin hydrochloride|Given IV
12072635|NCT00005977|Drug|etoposide|Given IV
12072636|NCT00005977|Drug|ifosfamide|Given IV
12072637|NCT00005977|Drug|leucovorin calcium|Given IV
12072638|NCT00005977|Drug|methotrexate|Given IV
12072639|NCT00005977|Drug|vincristine sulfate|Given IV
12072640|NCT00005971|Drug|alvocidib|
12072641|NCT00005956|Biological|HER-2/neu intracellular domain protein|
12072642|NCT00005956|Biological|therapeutic autologous dendritic cells|
12072643|NCT00005868|Drug|cisplatin|
12072647|NCT00005813|Biological|lymphokine-activated killer cells|
12072648|NCT00005813|Procedure|conventional surgery|
12072649|NCT00060983|Procedure|Body weight supported locomotor training|
12072650|NCT00060983|Procedure|Functional electrical stimulation|
12072651|NCT00060970|Procedure|Physical Therapy|
12072652|NCT00060957|Drug|Botulinum toxin type A|
12072653|NCT00060944|Drug|Yondelis|1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
12072654|NCT00060944|Drug|Yondelis|0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
12072655|NCT00060944|Drug|Dexamethasone|Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
12072656|NCT00060944|Drug|Dexamethasone|Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.
12072657|NCT00005861|Drug|pegylated liposomal doxorubicin hydrochloride|
12072658|NCT00005588|Radiation|radiation therapy|
12072659|NCT00005587|Radiation|radiation therapy|
12072660|NCT00003203|Biological|filgrastim|Given IV
12072661|NCT00003203|Drug|carboplatin|Given IV
12072662|NCT00003203|Drug|cisplatin|Given IV
12072663|NCT00003203|Drug|cyclophosphamide|Given IV
12072664|NCT00003203|Drug|vincristine sulfate|Given IV
12072665|NCT00003203|Procedure|adjuvant therapy|
12072666|NCT00003203|Radiation|radiation therapy|1.8 Gy/fx x 20fx=36Gy Craniospinal XRT*
12072667|NCT00060931|Drug|carvedilol|
12072668|NCT00060931|Drug|metoprolol|
12072669|NCT00060918|Drug|carvedilol|
12072670|NCT00060918|Drug|metoprolol|
12072671|NCT00060905|Drug|Divalproex Sodium (Depakote ER)|
12072672|NCT00060892|Genetic|HGF plasmid|Intramuscular injections into index leg on Days 0, 14, and 28
12072673|NCT00005086|Drug|cisplatin|
12072674|NCT00005086|Drug|docetaxel|
12072675|NCT00005086|Drug|gemcitabine hydrochloride|
12072676|NCT00005086|Drug|methotrexate|
12072677|NCT00005078|Drug|carboplatin|
12072678|NCT00005078|Drug|paclitaxel|
12072679|NCT00005078|Drug|tirapazamine|
12072680|NCT00060866|Drug|Propranolol|
12072681|NCT00060840|Drug|Nitric Oxide|40 ppm of Nitric Oxide continuously administered for 48 hours
12072682|NCT00060840|Drug|Nitrogen|Nitrogen (N2) administered at 40 ppm for 48 hours
12072683|NCT00060827|Device|Head Impact Recording Technology (HIRT)|
12072684|NCT00060814|Other|Combined intervention|300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling
12072685|NCT00060801|Drug|BIIL 283 BS (Amelubent)|
12072686|NCT00004931|Drug|leucovorin calcium|Given IV
12072687|NCT00004931|Drug|fluorouracil|Given IV
12072688|NCT00004931|Drug|oxaliplatin|Given IV
12072689|NCT00004931|Other|laboratory biomarker analysis|Correlative studies
12072690|NCT00004928|Dietary Supplement|calcitriol|
12072691|NCT00004928|Drug|zoledronic acid|
12072692|NCT00004925|Biological|trastuzumab|
12072693|NCT00004925|Drug|pegylated liposomal doxorubicin hydrochloride|
12072694|NCT00004916|Drug|ifosfamide|
12072695|NCT00004916|Drug|paclitaxel|
12072696|NCT00004916|Drug|teniposide|
12072697|NCT00004916|Procedure|peripheral blood stem cell transplantation|
12072698|NCT00004911|Procedure|bowel obstruction management|
12072699|NCT00004911|Procedure|quality-of-life assessment|
12072700|NCT00060762|Behavioral|Interpersonal Therapy|20 sessions of interpersonal therapy were provided over a 6-month period
12072701|NCT00060762|Behavioral|Behavioral Weight Loss Treatment|20 sessions of behavioral weight loss treatment were provided over a 6-month period
12072702|NCT00060762|Behavioral|Guided Self Help|10 sessions of guided self help were provided over a 6-month period
12072703|NCT00060710|Drug|CP-461|
12072704|NCT00060749|Drug|Docosahexaenoic Acid (DHA) Dietary Supplement|
12072705|NCT00060697|Behavioral|Adolescent sexual activity education for mothers|
12072706|NCT00060684|Drug|Pixantrone (BBR 2778)|
12072707|NCT00060684|Drug|fludarabine|
12072708|NCT00060684|Drug|dexamethasone|
12072709|NCT00060684|Drug|rituximab|
12072710|NCT00060671|Drug|rituximab|
12072711|NCT00060671|Drug|Pixantrone (BBR 2778)|
12072712|NCT00060645|Drug|ridaforolimus|There are sequential dosage cohorts ranging from 3 mg - 225 mg per dose. AP23573 is given intravenously over 30 minutes, administered once daily for 5 days every 2 weeks.
12072713|NCT00060632|Drug|ridaforolimus|"Administered intravenously once weekly for 4 weeks (1 cycle).
~In the absence of disease progression or unacceptable toxicity, patients could continue to receive additional cycles."
12072714|NCT00060619|Behavioral|thermal biofeedback|
12072715|NCT00060619|Behavioral|relaxation training|
12072716|NCT00060619|Behavioral|cognitive coping skills|
12072717|NCT00060619|Behavioral|parent education|
12072718|NCT00060606|Procedure|Prenatal Myelomeningocele Repair Surgery|Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation.
12072719|NCT00060606|Procedure|Postnatal Myelomeningocele Repair Surgery|Standard postnatal surgical closure of the spina bifida defect
12072720|NCT00060567|Drug|E7070 + irinotecan combination|Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.
12072721|NCT00060567|Drug|Irinotecan + E7070 combination|Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
12072722|NCT00060567|Drug|Irinotecan + E7070 combination|Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
12072723|NCT00004910|Procedure|bowel obstruction management|
12072724|NCT00004910|Procedure|quality-of-life assessment|
12072725|NCT00004895|Drug|octreotide acetate|
12072726|NCT00004255|Biological|anti-thymocyte globulin|
12072727|NCT00004255|Biological|filgrastim|
12072728|NCT00004255|Drug|cyclophosphamide|
12072729|NCT00004255|Drug|fludarabine phosphate|
12072732|NCT00004255|Procedure|allogeneic bone marrow transplantation|
12072733|NCT00004255|Procedure|in vitro-treated bone marrow transplantation|
12072734|NCT00004255|Radiation|radiation therapy|
12072735|NCT00004232|Biological|filgrastim|
12072736|NCT00004232|Drug|cyclosporine|
12072737|NCT00004232|Drug|methylprednisolone|
12072738|NCT00004232|Drug|prednisone|
12072739|NCT00004232|Procedure|allogeneic bone marrow transplantation|
12072740|NCT00004232|Procedure|peripheral blood stem cell transplantation|
12072741|NCT00004180|Drug|rosiglitazone maleate|
12072742|NCT00060580|Procedure|Raman scattering spectroscopy|
12072743|NCT00060554|Drug|fondaparinux sodium|
12072744|NCT00060554|Drug|heparin|
12072745|NCT00060554|Procedure|percutaneous coronary intervention (PCI)|
12072746|NCT00060515|Drug|RG2133 (2',3',5'-tri-O-acetyluridine)|
12072747|NCT00060502|Drug|Infliximab; Gemcitabine|
12072748|NCT00060489|Drug|SEROQUEL (quetiapine fumarate) Tablets|
12072749|NCT00004094|Drug|carboplatin|
12072750|NCT00004094|Drug|fluorouracil|
12072751|NCT00004094|Drug|hydroxyurea|
12072752|NCT00004094|Drug|paclitaxel|
12072753|NCT00004094|Procedure|conventional surgery|
12072754|NCT00004094|Radiation|radiation therapy|
12072755|NCT00004068|Drug|irinotecan hydrochloride|
12072756|NCT00004068|Drug|temozolomide|
12072757|NCT00004068|Procedure|conventional surgery|
12072758|NCT00004068|Radiation|radiation therapy|
12072759|NCT00004059|Drug|7-hydroxystaurosporine|
12072760|NCT00004059|Drug|fluorouracil|
12072761|NCT00004052|Biological|QS21|
12072762|NCT00004052|Biological|bcr-abl peptide vaccine|
12072763|NCT00004008|Drug|bryostatin 1|
12072764|NCT00060528|Drug|Recombinant Fowlpox-GM-CSF|
12072765|NCT00060528|Drug|Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM)|
12072766|NCT00060528|Drug|Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM)|
12072767|NCT00060528|Drug|Recombinant Human GM-CSF|
12072768|NCT00060476|Drug|rofecoxib|
12072769|NCT00060476|Drug|Comparator: placebo (unspecified)|
12072770|NCT00060463|Behavioral|Increased access to emergency contraceptive pills|
12072771|NCT00060450|Drug|nitric oxide for inhalation|Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
12072772|NCT00060450|Drug|Placebo|Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant
12072773|NCT00060437|Drug|perifosine|
12072774|NCT00060424|Drug|Cyclosporine|Given PO
12072775|NCT00060424|Drug|Fludarabine Phosphate|Given IV
12072776|NCT00060424|Procedure|Hematopoietic Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplant
12072777|NCT00060424|Other|Laboratory Biomarker Analysis|Correlative studies
12072778|NCT00060424|Drug|Mycophenolate Mofetil|Given PO
12072779|NCT00060424|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplant
12072780|NCT00060424|Radiation|Total-Body Irradiation|Undergo TBI
12072781|NCT00060411|Drug|erlotinib hydrochloride|Given IV
12072782|NCT00060411|Drug|fluorouracil|Given IV
12072783|NCT00060411|Drug|leucovorin calcium|Given IV
12072784|NCT00060411|Drug|oxaliplatin|Given IV
12072785|NCT00060411|Biological|bevacizumab|Given IV
12072786|NCT00060398|Biological|epoetin alfa|
12072787|NCT00060398|Drug|dexamethasone|
12072788|NCT00060385|Drug|CHOP regimen|
12072789|NCT00060385|Drug|EPOCH regimen|
12072790|NCT00060385|Drug|cyclophosphamide|
12072791|NCT00060385|Drug|doxorubicin hydrochloride|
12072792|NCT00060385|Drug|etoposide|
12072793|NCT00060385|Drug|prednisone|
12072794|NCT00060385|Drug|vincristine sulfate|
12072795|NCT00060385|Radiation|radiation therapy|
12072796|NCT00060372|Drug|ipilimumab|Given IV
12072797|NCT00060372|Drug|therapeutic allogeneic lymphocytes|Given IV
12072798|NCT00060359|Drug|Carboplatin|Given IV
12072799|NCT00060359|Drug|Paclitaxel Poliglumex|Given IV
12072800|NCT00060359|Other|Pharmacological Study|Correlative studies
12072801|NCT00060346|Biological|rituximab|Rituximab is given intravenously. The initial rate is 50 mg/hr for the 1st hour. If no toxicity, the rate may be escalated in 50 mg/hr increments at 30-minute intervals to a maximum of 400 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr. If the patient experiences fever and rigors, the antibody infusion is discontinued. The severity of the side effects should be evaluated. If the symptoms improve, the infusion is continued initially at half the previous rate. Following the antibody infusion, the intravenous line should be maintained for medications as needed. If there are no complications after one hour of observation, the intravenous line may be discontinued.
12072802|NCT00060346|Drug|cyclophosphamide|"Cyclophosphamide will be given at a dosage of 750 mg/m² intravenously on day 1 of each cycle (1 cycle =21 days) for 6 cycles. Dose is based on surface area calculated based on actual body weight.
~The drug should be administered as a rapid IV infusion over 5 to 30 minutes."
12072803|NCT00060346|Drug|Doxorubicin|"Doxorubicin will be given intravenously at a dosage of 50 mg/m² on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
~Doxorubicin should be administered as a continuous infusion into tubing of a freely flowing intravenous line for 5 -15 minutes. Avoid extravasation."
12072804|NCT00060346|Drug|Prednisone|Prednisone will be administered at 100 mg/m² orally, days 1-5 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
12072805|NCT00060346|Drug|Vincristine|"Vincristine will be administered 1.4 mg/m² intravenously (Maximum dose = 2.0 mg) on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
~Given as IV push over 1 minute, using extravasation precautions."
12072806|NCT00060333|Radiation|radiation therapy|
12072807|NCT00060320|Dietary Supplement|black cohosh|
12072808|NCT00060320|Other|placebo|
12072809|NCT00060307|Drug|erlotinib hydrochloride|Given orally
12072810|NCT00060307|Other|laboratory biomarker analysis|Correlative studies
12072811|NCT00060294|Biological|rituximab|
12072812|NCT00060294|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12072813|NCT00060268|Drug|HPPH|iv
12072814|NCT00060255|Drug|busulfan|iv
12072815|NCT00060255|Drug|carboplatin|iv
12072816|NCT00060255|Drug|carmustine|iv
12072817|NCT00060255|Drug|cyclophosphamide|iv
12072818|NCT00060255|Drug|etoposide|iv
12072819|NCT00060255|Drug|melphalan|oral
12072820|NCT00060255|Drug|thiotepa|iv
12072821|NCT00060255|Procedure|autologous bone marrow transplantation|iv
12072822|NCT00060255|Procedure|bone marrow ablation with stem cell support|iv
12072823|NCT00060255|Procedure|peripheral blood stem cell transplantation|iv
12072824|NCT00060255|Radiation|radiation therapy|body x-ray
12072825|NCT00060242|Drug|fosbretabulin disodium|Combretastatin A4 phosphate IV over 10 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of the CR.
12072826|NCT00060203|Drug|brostallicin|"Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
~Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity."
12072827|NCT00060151|Drug|pazopanib hydrochloride|
12072828|NCT00060138|Biological|monoclonal antibody CAL|
12072829|NCT00060138|Drug|zoledronic acid|
12072830|NCT00060125|Drug|tipifarnib|Given orally
12072831|NCT00060125|Other|laboratory biomarker analysis|Correlative studies
12072832|NCT00060112|Biological|oblimersen sodium|Given IV
12072833|NCT00060112|Drug|gemcitabine hydrochloride|Given IV
12072834|NCT00060112|Other|pharmacological study|Correlative studies
12072835|NCT00060112|Other|laboratory biomarker analysis|Correlative studies
12072836|NCT00060099|Biological|HspE7|
12072837|NCT00060086|Dietary Supplement|pomegranate juice|Subjects receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
12072838|NCT00060021|Procedure|acupuncture therapy|
12072839|NCT00060021|Procedure|management of therapy complications|
12072840|NCT00060021|Procedure|pain therapy|
12072841|NCT00060008|Radiation|fludeoxyglucose F 18|
12072842|NCT00060008|Radiation|gadopentetate dimeglumine|
12072843|NCT00059995|Biological|iratumumab|
12072844|NCT00059982|Drug|perifosine|
12072845|NCT00059943|Drug|docetaxel|
12072846|NCT00059930|Drug|FOLFOX regimen|
12072847|NCT00059930|Drug|dexamethasone|
12072848|NCT00059930|Drug|floxuridine|
12072849|NCT00059930|Drug|fluorouracil|
12072850|NCT00059930|Drug|leucovorin calcium|
12072851|NCT00059930|Drug|oxaliplatin|
12072852|NCT00059930|Procedure|adjuvant therapy|
12072853|NCT00059930|Procedure|conventional surgery|
12072854|NCT00059917|Drug|polyglutamate camptothecin|
12072855|NCT00059904|Biological|aldesleukin|
12072856|NCT00059904|Biological|rituximab|
12072857|NCT00059891|Procedure|conventional surgery|
12072858|NCT00059891|Procedure|management of therapy complications|
12072859|NCT00059878|Biological|recombinant interferon gamma|
12072860|NCT00059878|Drug|voriconazole|
12072861|NCT00059865|Drug|gemcitabine hydrochloride|
12072862|NCT00059865|Drug|pemetrexed disodium|
12072863|NCT00059852|Drug|erlotinib hydrochloride|
12072864|NCT00059852|Drug|gemcitabine hydrochloride|
12072865|NCT00059839|Drug|doxorubicin hydrochloride|Given IV
12072866|NCT00059839|Drug|mercaptopurine|Given by mouth
12072867|NCT00059839|Drug|methotrexate|Given IV and intrathecally
12072868|NCT00059839|Drug|prednisone|Given by mouth
12072869|NCT00059839|Drug|vinblastine sulfate|Given IV
12072870|NCT00059839|Drug|vincristine sulfate|Given IV
12072871|NCT00059826|Biological|interferon-alfa-2b|IV
12072872|NCT00059826|Drug|cisplatin|IV
12072873|NCT00059826|Drug|5-fluorouracil|IV
12072874|NCT00059826|Radiation|radiation therapy|
12072875|NCT00059813|Biological|recombinant interferon alfa|Given SC
12072876|NCT00059813|Biological|oblimersen sodium|Given IV
12072877|NCT00059813|Other|pharmacological study|Correlative studies
12072878|NCT00059800|Radiation|boron neutron capture therapy|
12072879|NCT00059787|Drug|paclitaxel|Given IV
12072880|NCT00059787|Drug|carboplatin|Given IV
12072881|NCT00059787|Drug|erlotinib|Given PO
12072882|NCT00059761|Drug|cisplatin|
12072883|NCT00059761|Drug|irinotecan hydrochloride|
12072884|NCT00059761|Radiation|radiation therapy|
12072885|NCT00059735|Drug|E7070|
12072886|NCT00043108|Drug|carboplatin|
12072887|NCT00043108|Drug|paclitaxel|
12072888|NCT00043108|Procedure|conventional surgery|
12072889|NCT00043108|Radiation|radiation therapy|
12072890|NCT00030667|Drug|imatinib mesylate|Given orally
12072891|NCT00030667|Other|laboratory biomarker analysis|Correlative studies
12072892|NCT00030667|Other|pharmacological study|Correlative studies
12072893|NCT00030524|Drug|gefitinib|
12072894|NCT00027599|Biological|bevacizumab|
12072895|NCT00027599|Biological|prostatic acid phosphatase-sargramostim fusion protein|
12072896|NCT00027599|Biological|sipuleucel-T|
12072897|NCT00027599|Biological|therapeutic autologous dendritic cells|
12072898|NCT00027599|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12072899|NCT00017134|Drug|fenretinide|
12072900|NCT00017134|Procedure|conventional surgery|
12072901|NCT00016315|Drug|carboplatin|
12072902|NCT00016315|Drug|gemcitabine hydrochloride|
12072904|NCT00016315|Radiation|radiation therapy|
12072905|NCT00006225|Biological|filgrastim|
12072906|NCT00006225|Biological|recombinant flt3 ligand|
12072907|NCT00006225|Biological|recombinant human thrombopoietin|
12072908|NCT00006225|Biological|recombinant interleukin-3|
12072909|NCT00006225|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12072910|NCT00005793|Drug|Cytarabine|
12072911|NCT00005793|Drug|Daunorubicin|
12072912|NCT00005793|Drug|Etoposide|
12072913|NCT00005793|Drug|Topotecan|
12072914|NCT00005065|Drug|paclitaxel|Given IV
12072915|NCT00005065|Drug|carboplatin|Given IV
12072916|NCT00005065|Drug|motexafin gadolinium|Given IV
12072917|NCT00005065|Procedure|conventional surgery|Undergo complete surgical resection
12072918|NCT00005065|Radiation|radiation therapy|Undergo radiation therapy
12072919|NCT00004127|Drug|FOLFOX regimen|
12072920|NCT00004127|Drug|fluorouracil|
12072921|NCT00004127|Drug|leucovorin calcium|
12072922|NCT00004127|Drug|oxaliplatin|
12072923|NCT00004095|Drug|gemcitabine hydrochloride|
12072924|NCT00004095|Drug|irinotecan hydrochloride|
12072925|NCT00019435|Biological|LMB-9 immunotoxin|
12072926|NCT00002765|Biological|LMB-2 immunotoxin|
12072927|NCT00059722|Drug|ZD6474|
12072928|NCT00059722|Drug|Placebo|
12072929|NCT00059722|Drug|ZD1839|
12072930|NCT00059709|Procedure|Mediated Negotiation Training|
12072931|NCT00059696|Procedure|Constraint-Induced Movement Therapy|
12072932|NCT00059683|Procedure|cervical cerclage|Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix
12072933|NCT00018941|Biological|aldesleukin|
12072934|NCT00005837|Drug|oxaliplatin|
12072935|NCT00005818|Drug|irinotecan hydrochloride|Given IV
12072936|NCT00005818|Drug|semaxanib|Given IV
12072937|NCT00005818|Other|laboratory biomarker analysis|Correlative studies
12072938|NCT00005025|Biological|herpes simplex thymidine kinase|
12072939|NCT00005025|Drug|ganciclovir|
12072940|NCT00002971|Drug|O6-benzylguanine|
12072941|NCT00059670|Procedure|Shaker Exercise vs. Traditional Dysphagia Therapy Regime|
12072942|NCT00059657|Drug|Ecraprost in lipid emulsion|
12072943|NCT00059644|Drug|Ecraprost in lipid emulsion|
12072944|NCT00003933|Other|laboratory biomarker analysis|
12072945|NCT00003926|Drug|amifostine trihydrate|"Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1.
~Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined."
12072946|NCT00003926|Drug|busulfan|Patients receive oral busulfan every 6 hours on days -8 to -6.
12072947|NCT00003926|Drug|filgrastim|All patients receive filgrastim (G-CSF) IV for 1 week.
12072948|NCT00003926|Drug|melphalan|melphalan intravenous (IV) over 30 minutes on days -5 and -4
12072949|NCT00003926|Drug|thiotepa|thiotepa intravenous (IV) over 2 hours on days -3 and -2.
12072950|NCT00003926|Procedure|peripheral blood stem cell transplantation (PBSC)|PBSC are reinfused on day 0
12072951|NCT00003925|Drug|gemcitabine hydrochloride|
12072952|NCT00003925|Drug|leucovorin calcium|
12072953|NCT00003925|Drug|tegafur-uracil|
12072954|NCT00003802|Drug|pyrazoloacridine|
12072955|NCT00003797|Biological|trastuzumab|
12072956|NCT00003797|Drug|gemcitabine hydrochloride|
12072957|NCT00059631|Drug|Mitoxantrone (Novantrone)|Starting dose of 3 mg/m^2, four weekly intravenous injections (on Days 1, 8, 15 and 22) over eight 5 week cycles.
12072958|NCT00059631|Drug|Bortezomib (PS-341)|Starting Dose of 1.4 mg/m^2, four weekly intravenous injections (on Days 1, 8, 15, and 22) over eight 5 week cycles.
12072959|NCT00059618|Drug|PS-341 (Bortezomib)|Starting dose 0.8 mg/m^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles.
12072960|NCT00059618|Drug|Carboplatin|AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.
12072961|NCT00059605|Genetic|DOTAP:Chol-fus1|Infusion of DOTAP:Chol-fus1 by vein once every 3 weeks.
12072962|NCT00059592|Drug|Valacyclovir|
12072963|NCT00003757|Biological|rituximab|
12072964|NCT00003649|Biological|Ad5CMV-p53 gene|
12072965|NCT00003627|Drug|cisplatin|
12072966|NCT00003627|Drug|fluorouracil|
12072967|NCT00003627|Radiation|radiation therapy|
12072968|NCT00003484|Drug|carmustine|
12072969|NCT00003484|Drug|irinotecan hydrochloride|
12072970|NCT00003484|Procedure|surgical procedure|
12072971|NCT00003484|Radiation|iodine I 131 monoclonal antibody 81C6|
12072972|NCT00003436|Drug|amsacrine|
12072973|NCT00003436|Drug|asparaginase|
12072974|NCT00003436|Drug|cytarabine|
12072975|NCT00003436|Drug|daunorubicin hydrochloride|
12072976|NCT00003436|Drug|etoposide|
12072977|NCT00003436|Drug|methotrexate|
12072978|NCT00003436|Drug|mitoxantrone hydrochloride|
12072979|NCT00003436|Drug|therapeutic hydrocortisone|
12072980|NCT00003436|Procedure|allogeneic bone marrow transplantation|
12072981|NCT00059553|Behavioral|Locomotor treadmill training with body weight support|
12072982|NCT00059527|Behavioral|Healthy Youth Places: a behavior change model|
12072983|NCT00059514|Behavioral|Modified Project Toward No Tobacco Use|
12072984|NCT00005836|Drug|oxaliplatin|
12072985|NCT00059475|Drug|Glycoprotein 100 (GP100): 209-217 (210M)|
12072986|NCT00059475|Drug|Interleukin-2 (IL-2)|720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours and continuing for up to 4 days (a maximum of 12 doses).
12072987|NCT00059475|Drug|Montanide ISA 51|
12072988|NCT00059475|Drug|Melanoma antigen recognized by T-cells (MART)-1: 27-35|
12072989|NCT00059475|Drug|27-35 (27L): melanoma antigen recognized by T-cells (MART)-1|
12072990|NCT00059475|Drug|melanoma antigen recognized by T-cells (MART)-1: 26-35(27L)|
12072991|NCT00059436|Behavioral|Mental effort in muscle strengthening|
12072992|NCT00003432|Biological|carcinoembryonic antigen RNA-pulsed DC cancer vaccine|Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses.
12072993|NCT00003346|Drug|acetaminophen|
12072994|NCT00003346|Drug|acetylcysteine|
12072995|NCT00003346|Drug|carmustine|
12072996|NCT00003341|Biological|epoetin alfa|
12072997|NCT00003341|Procedure|quality-of-life assessment|
12072998|NCT00003324|Procedure|conventional surgery|
12072999|NCT00003324|Radiation|radiation therapy|
12073000|NCT00003311|Biological|filgrastim|
12073001|NCT00003311|Drug|cyclophosphamide|
12073002|NCT00003311|Drug|cytarabine|
12073003|NCT00003311|Drug|dexamethasone|
12073004|NCT00003311|Drug|doxorubicin hydrochloride|
12073005|NCT00003311|Drug|methotrexate|
12073006|NCT00003311|Drug|vincristine sulfate|
12073007|NCT00059384|Behavioral|Concentration-controlled therapy|
12073008|NCT00059371|Procedure|male circumcision|
12073009|NCT00059358|Drug|Ribavirin plus interferon alfa-2b|Oral tablets taken daily
12073010|NCT00059358|Drug|Ribavirin|Oral tablet taken daily
12073011|NCT00059358|Drug|Peginterferon alfa-2b|Subcutaneous injection
12073012|NCT00059345|Procedure|Acupuncture|Electroacupuncture treatments provided two times per week for 6 weeks
12073013|NCT00059345|Procedure|Placebo acupuncture|Placebo acupuncture treatments provided 2 times per week for 6 weeks
12073014|NCT00059345|Other|Usual Care|Usual care for knee osteoarthritis
12073015|NCT00059332|Drug|Magnesium Sulfate|Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
12073016|NCT00059332|Drug|Normal Saline|Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
12073017|NCT00059319|Procedure|single aorta clamp with retrograde cardioplegia|
12073018|NCT00059319|Procedure|multiple aorta clamps with antegrade cardioplegia|
12073019|NCT00059306|Drug|aspirin|Participants receive aspirin + placebo, specifically: aspirin (325 mg) with placebo (an inactive substance). Participants will take 1 of each pill a day until the end of the study.
12073020|NCT00059306|Drug|clopidogrel|Participants will receive aspirin + clopidogrel, specifically: aspirin (325 mg) with clopidogrel (75 mg)-- Participants will take 1 of each pill a day until the end of the study.
12073021|NCT00059306|Other|Target of Blood Pressure|Participants will be assigned to one of 2 groups of blood pressure control. The difference between the two groups is the target level of systolic blood pressure-either 130-149 mmHg or below 130 mmHg; to do so, the scientists will use medications that are already in the market for blood pressure management.
12073022|NCT00059306|Other|placebo|an inactive substance
12073023|NCT00058981|Drug|DiaPep277|
12073024|NCT00059280|Biological|Myozyme|20 mg/kg qow or 40mg/kg qow
12073025|NCT00059267|Drug|HBIG, Epivir, Hepsera|
12073026|NCT00059254|Dietary Supplement|Oleic acid (OA)|OA-enriched (HI OA; fat, 40%; PA, 1.7%; OA, 31.4%)
12073027|NCT00059254|Dietary Supplement|Palmitic Acid (PA)|PA-enriched (HI PA; fat, 40% of energy; PA, 16.8%; OA, 16.4%)
12073028|NCT00059241|Behavioral|Parent-child communication education|
12073029|NCT00059241|Behavioral|Service learning|
12073030|NCT00059241|Behavioral|Classroom health curriculum|
12073031|NCT00059215|Drug|Prasugrel (CS-747)|Administered orally
12073032|NCT00059215|Drug|Clopidogrel|Administered orally
12073033|NCT00003290|Biological|gonadotrophin releasing hormone|
12073034|NCT00003290|Radiation|radiation therapy|
12073035|NCT00003262|Biological|bleomycin sulfate|
12073036|NCT00003262|Biological|filgrastim|
12073037|NCT00003262|Drug|Stanford V regimen|
12073038|NCT00003262|Drug|doxorubicin hydrochloride|
12073039|NCT00003262|Drug|epirubicin hydrochloride|
12073040|NCT00003262|Drug|etoposide|
12073041|NCT00003262|Drug|mechlorethamine hydrochloride|
12073042|NCT00003262|Drug|prednisone|
12073043|NCT00003262|Drug|vinblastine sulfate|
12073044|NCT00003262|Drug|vincristine sulfate|
12073045|NCT00003205|Drug|bryostatin 1|
12073046|NCT00003193|Drug|amifostine trihydrate|
12073047|NCT00003193|Drug|paclitaxel|
12073048|NCT00003193|Procedure|conventional surgery|
12073049|NCT00003193|Radiation|radiation therapy|
12073050|NCT00003173|Biological|filgrastim|
12073051|NCT00003173|Drug|thiotepa|
12073052|NCT00003173|Procedure|autologous bone marrow transplantation|
12073053|NCT00003173|Procedure|peripheral blood stem cell transplantation|
12073054|NCT00059228|Drug|17beta Estradiol|Alora 100 microgram per day by skin patch for 6 weeks.
12073055|NCT00059228|Drug|Placebos|Placebo skin patch for 6 weeks
12073056|NCT00059202|Drug|Ursodeoxycholic Acid|
12073057|NCT00059189|Device|Magstim Rapid Magnetic Stimulator|
12073058|NCT00005839|Drug|capecitabine|
12073059|NCT00005839|Drug|oxaliplatin|
12073060|NCT00004220|Drug|gemcitabine hydrochloride|
12073061|NCT00004220|Drug|oxaliplatin|
12073062|NCT00004257|Drug|fluorouracil|
12073063|NCT00004257|Drug|oxaliplatin|
12073064|NCT00004257|Procedure|conventional surgery|
12073065|NCT00004257|Radiation|radiation therapy|
12073066|NCT00004243|Drug|docetaxel|
12073067|NCT00004243|Drug|oxaliplatin|
12073068|NCT00003597|Biological|recombinant human thrombopoietin|
12073069|NCT00003597|Drug|carboplatin|
12073070|NCT00003597|Drug|etoposide|
12073071|NCT00003597|Drug|ifosfamide|
12073072|NCT00003597|Biological|G-CSF|
12073073|NCT00003163|Biological|filgrastim|
12073074|NCT00003163|Biological|sargramostim|
12073075|NCT00003163|Drug|cyclophosphamide|
12073076|NCT00003163|Drug|melphalan|
12073077|NCT00003163|Procedure|autologous bone marrow transplantation|
12073078|NCT00003163|Procedure|peripheral blood stem cell transplantation|
12073079|NCT00003163|Radiation|radiation therapy|
12073080|NCT00003162|Procedure|pain therapy|
12073081|NCT00003162|Radiation|radiation therapy|
12073082|NCT00003129|Drug|valrubicin|
12073083|NCT00003124|Drug|flutamide|
12073084|NCT00003124|Drug|leuprolide acetate|
12073085|NCT00003124|Radiation|radiation therapy|
12073086|NCT00003064|Biological|filgrastim|
12073087|NCT00003064|Drug|carboplatin|
12073088|NCT00003064|Drug|etoposide phosphate|
12073089|NCT00003064|Drug|paclitaxel|
12073090|NCT00003064|Drug|thiotepa|
12073091|NCT00003064|Drug|topotecan hydrochloride|
12073092|NCT00003064|Procedure|peripheral blood stem cell transplantation|
12073093|NCT00002972|Drug|paclitaxel|
12073094|NCT00058994|Drug|anecortave acetate|
12073095|NCT00058968|Drug|Duloxetine hydrochloride|
12073096|NCT00058968|Drug|placebo|
12073097|NCT00058955|Drug|sodium oxybate, triazolam and pentobarbital|sodium oxybate, triazolam and pentobarbital
12073098|NCT00058942|Device|home drinking water treatment device|
12073099|NCT00058929|Drug|treprostinil sodium|
12073100|NCT00058903|Drug|sertraline|
12073101|NCT00058890|Drug|Gabapentin|Under code, the study drug was started at 100 mg by mouth 3 times a day for 3 days, to be increased, if necessary and in the absence of side effects, by 300 mg every 3 days to a maximum of 2,400 mg daily in divided doses.
12073102|NCT00058890|Drug|Placebo|
12073103|NCT00002945|Biological|aldesleukin|IV
12073104|NCT00002945|Biological|filgrastim|IV
12073105|NCT00002945|Drug|cyclophosphamide|IV
12073106|NCT00002945|Drug|cytarabine|IV
12073107|NCT00002945|Drug|etoposide|IV
12073108|NCT00002945|Drug|idarubicin|IV
12073109|NCT00002945|Drug|melphalan|IV
12073110|NCT00002945|Procedure|peripheral blood stem cell transplantation|IV
12073111|NCT00002945|Radiation|radiation therapy|delivered to the cancer cells
12073112|NCT00002934|Procedure|long-term screening|
12073113|NCT00002835|Biological|Bleomycin Sulfate (BLM)|
12073114|NCT00002835|Biological|Filgrastim (G-CSF)|Arm 1: Administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover through Course 1 then 2 courses administered before PBSC harvest and same regimen with Course 2, then daily with Day 0 of infusion.
12073115|NCT00002835|Biological|Recombinant Interferon Alfa|
12073116|NCT00002835|Drug|Carmustine|Arm 1, Course 3, IV over 1 hour on day -6.
12073117|NCT00002835|Drug|Cisplatin (CDDP)|
12073118|NCT00002835|Drug|Cyclophosphamide|
12073119|NCT00002835|Drug|Cytarabine (ARA-C)|Arm 1, Course 3, every 12 hours on days -5 to -2.
12073120|NCT00002835|Drug|Etoposide (VP-16)|Course 1, IV over 2 hours every 12 hours on days 1-3; Course 3, every 12 hours on days -5 to -2.
12073121|NCT00002835|Drug|Idarubicin|
12073122|NCT00002835|Drug|Ifosfamide|During Course 1, IV continuously; Course 2, IV continuously on days 1-3.
12073123|NCT00002835|Drug|Leucovorin Calcium|
12073124|NCT00002835|Drug|Melphalan|
12073125|NCT00002835|Drug|Methotrexate|
12073126|NCT00002835|Drug|Methylprednisolone|
12073127|NCT00002835|Drug|mitoxantrone hydrochloride (DHAD)|Arm 1, Course 2, IV on day 1.
12073128|NCT00002835|Drug|Vincristine Sulfate|
12073129|NCT00002835|Procedure|Peripheral Blood Stem Cell Transplantation|Infusion of stem cells on Day 0.
12073130|NCT00002835|Radiation|Radiation Therapy|
12073131|NCT00002822|Drug|carboplatin|
12073132|NCT00002822|Drug|cisplatin|
12073133|NCT00002822|Drug|cyclophosphamide|
12073134|NCT00002822|Drug|doxorubicin hydrochloride|
12073135|NCT00002822|Drug|etoposide|
12073136|NCT00002822|Drug|ifosfamide|
12073137|NCT00002822|Drug|mesna|
12073138|NCT00002822|Drug|vincristine sulfate|
12073139|NCT00002822|Radiation|radiation therapy|
12073140|NCT00058864|Device|Energy absorbing and distributing trochanteric pad|
12073141|NCT00058851|Procedure|Manual lymph drainage|
12073142|NCT00058851|Procedure|Combined physiotherapy|
12073143|NCT00058851|Procedure|Compression bandaging|
12073144|NCT00058838|Drug|sumanirole|
12073145|NCT00058825|Biological|Campath 1H|Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
12073146|NCT00058825|Drug|Fludarabine|Day -5 to Day -2: Fludarabine 30 mg/m2.
12073147|NCT00058825|Procedure|Stem Cell Transplant|Day 0: Donor stem cells infused.
12073148|NCT00058825|Radiation|Total Body Irradiation (TBI)|Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
12073149|NCT00058825|Drug|FK506 (Tacrolimus) or Cyclosporine|Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.
12073150|NCT00058812|Biological|EBV specific T cells|One injection of 2x10^7 cells/m2 from Day 45 post transplant. If EBV DNA levels remain elevated above 1000 copies/ug or the patient has persistent disease they will be eligible to receive up to 5 additional injections of CTLs at the original dose at monthly intervals.
12073151|NCT00058799|Biological|Dose Level 1|Leukemic Blasts 2 x 10^7; IL-2 Fibroblasts 2 x 10^7; CD40L Fibroblasts 2 x 10^5
12073152|NCT00058799|Biological|Dose Level 2|Leukemic Blasts 2 x 10^7; IL-2 Fibroblasts 2 x 10^7; CD40L Fibroblasts 2 x 10^5
12073153|NCT00058799|Biological|Dose Level 3|Leukemic Blasts 2 x 10^7; IL-2 Fibroblasts 2 x 10^7; CD40L Fibroblasts 4.2 x 10^7
12073229|NCT00058487|Drug|epirubicin hydrochloride|
12073230|NCT00058487|Drug|thalidomide|
12073231|NCT00058474|Drug|capecitabine|825 mg/m2 oral daily 5 days a week on days of planned RT
12073232|NCT00058474|Drug|fluorouracil|225 mg/m2 IV daily continuous infusion
12073233|NCT00058474|Drug|oxaliplatin|50 mg/m2 IV 5 days a week on days of planned RT
12073234|NCT00058474|Radiation|radiation therapy|Given 5 days a week for 5-6 weeks
12073235|NCT00058461|Drug|ifosfamide|Given IV
12073236|NCT00058461|Drug|etoposide|Given IV
12073237|NCT00058461|Biological|rituximab|Given IV
12073238|NCT00058461|Drug|carboplatin|Given IV
12073154|NCT00058786|Biological|Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells|Patients may be treated with a minimum of three up to six injections of their IL-2-secreting and CD40L-expressing autologous B-CLL cells, separated by one to two weeks in an immunological treatment window, i.e. in the absence of concurrent cytotoxic therapy. Any patient whose disease regresses after the administration of 6 injections may be offered further injections (i.e. more than 6 injections) of tumor vaccine at the dose level previously administered, if enough vaccines are available. Patients will receive a fixed dose of IL-2 secreting B-CLL cells throughout the entire treatment protocol (see Section 5.8), determined by previous studies in acute leukemia and in neuroblastoma, in which this level of IL-2 production has been safe. The dose escalation of CD40L-expressing cells is designed to reach the IL2/CD40L ratio shown to be effective in our preclinical models of neuroblastoma and lymphoma.
12073155|NCT00058773|Drug|Infusion of EBV Specific Cytotoxic T-Lymphocytes|"EBV specific cytotoxic T-lymphocytes will be given by intravenous injection over 1-10 minutes.
~Each patient will receive two injections, 14 days apart."
12073156|NCT00058760|Behavioral|NIA intervention (after school health promotion didactic program)|
12073157|NCT00058747|Drug|Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.|
12073158|NCT00058734|Biological|Dendritic Cells Pulsed with HIV antigens|
12073159|NCT00058721|Drug|I-123-5-IA85380|
12073160|NCT00058682|Drug|Anidulafungin|
12073161|NCT00002777|Drug|exemestane|
12073162|NCT00002777|Drug|tamoxifen citrate|
12073163|NCT00002701|Drug|busulfan|
12073164|NCT00002701|Drug|cyclophosphamide|
12073165|NCT00002701|Drug|cytarabine|
12073166|NCT00002701|Drug|etoposide|
12073167|NCT00002701|Drug|idarubicin|
12073168|NCT00002701|Drug|mercaptopurine|
12073169|NCT00002701|Drug|methotrexate|
12073170|NCT00002701|Drug|mitoxantrone hydrochloride|
12073171|NCT00002701|Drug|thioguanine|
12073172|NCT00002701|Drug|tretinoin|
12073173|NCT00002701|Procedure|allogeneic bone marrow transplantation|
12073174|NCT00002701|Procedure|autologous bone marrow transplantation|
12073175|NCT00002701|Radiation|radiation therapy|
12073176|NCT00002695|Genetic|DNA stability analysis|
12073177|NCT00002695|Genetic|microsatellite instability analysis|
12073178|NCT00002695|Genetic|mutation analysis|
12073179|NCT00002695|Other|laboratory biomarker analysis|
12073180|NCT00002693|Biological|filgrastim|
12073181|NCT00002693|Drug|carboplatin|
12073182|NCT00002693|Drug|topotecan hydrochloride|
12073183|NCT00002669|Biological|aldesleukin|
12073184|NCT00002669|Biological|recombinant interferon alfa|
12073185|NCT00002669|Drug|cisplatin|
12073186|NCT00002669|Drug|dacarbazine|
12073187|NCT00058656|Procedure|Infusion of Activated & Expanded Autologous T Cells|
12073188|NCT00002658|Biological|filgrastim|
12073189|NCT00002658|Drug|amsacrine|
12073190|NCT00002658|Drug|cyclophosphamide|
12073191|NCT00002658|Drug|cytarabine|
12073192|NCT00002658|Drug|daunorubicin hydrochloride|
12073193|NCT00002658|Drug|etoposide|
12073194|NCT00002658|Drug|idarubicin|
12073195|NCT00002658|Drug|mitoxantrone hydrochloride|
12073196|NCT00002658|Drug|thioguanine|
12073197|NCT00002658|Drug|tretinoin|
12073198|NCT00002658|Procedure|allogeneic bone marrow transplantation|
12073199|NCT00002658|Procedure|autologous bone marrow transplantation|
12073200|NCT00002658|Procedure|peripheral blood stem cell transplantation|
12073201|NCT00002658|Radiation|radiation therapy|
12073202|NCT00002653|Drug|carmustine|
12073203|NCT00002653|Drug|cyclophosphamide|
12073204|NCT00002653|Drug|doxorubicin hydrochloride|
12073205|NCT00002653|Drug|melphalan|
12073206|NCT00002653|Drug|prednisone|
12073207|NCT00002653|Radiation|radiation therapy|
12073208|NCT00002575|Procedure|conventional surgery|
12073209|NCT00002575|Procedure|laparoscopic surgery|
12073210|NCT00002550|Drug|cisplatin|
12073211|NCT00002550|Drug|etoposide|
12073212|NCT00002550|Procedure|conventional surgery|
12073213|NCT00002550|Radiation|radiation therapy|
12073214|NCT00002539|Biological|filgrastim|
12073215|NCT00002539|Drug|cisplatin|
12073216|NCT00002539|Drug|doxorubicin hydrochloride|
12073217|NCT00002539|Procedure|conventional surgery|
12073218|NCT00058617|Biological|Injection of EBV Specific CTLs|"Each patient will receive two injections, 14 days apart, according to the following dosing schedules:
~Group One Day 0 2x10^7 cells/m2 Day 14 2x10^7 cells/m2
~Group Two Day 0 2x10^7 cells/m2 Day 14 1x10^8 cells/m2
~Group Three Day 0 1x10^8 cells/m2 Day 14 2x 10^8 cells/m2
~If patients with active disease have stable disease or a partial response by the RECIST criteria at their 8 week or subsequent evaluations they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number as their second injection. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
12073219|NCT00058604|Biological|Intravenous injection of EBV specific CTLs|Each patient will receive injections of 2x10e7 , 5x10e7 , or 10e8 CTLs/m2 via IV injection. 6 weeks = 1 course
12073220|NCT00058591|Biological|Intravenous injection of EBV specific CTLS|"The dose levels for this study are as follows:
~Level Dose
~2 x 107 CTLs/m2
~5 x 107 CTLs/m2
~1 x 108 CTLs/m2
~If patients have a clinical response to the first infusion defined by an improvement in the fatigue score or resolution of clinical abnormalities such as lymphadenopathy or an improvement in laboratory parameters such as a decrease in VCA titer or reduction in free EBV DNA they will be eligible to receive up to 3 additional injections of CTLs at the original dose at 3 monthly intervals."
12073221|NCT00058578|Drug|Cyclophosphamide|
12073222|NCT00058578|Drug|Mesna|
12073223|NCT00058578|Drug|G-CSF|
12073224|NCT00058578|Procedure|Leukopheresis|
12073225|NCT00058578|Procedure|Total Body Irradiation|
12073226|NCT00058552|Drug|Pertuzumab (rhuMAb 2C4)|
12073227|NCT00058539|Drug|rhuMAb 2C4 (pertuzumab)|
12073228|NCT00058526|Biological|Immunotherapeutic SB719125 (Primary)|Intramuscular injection
12073239|NCT00058461|Biological|filgrastim|Given SC
12073240|NCT00058461|Drug|methotrexate|Given IT
12073241|NCT00058461|Drug|cytarabine|Given IT
12073242|NCT00058461|Other|laboratory biomarker analysis|Correlative studies
12073243|NCT00058448|Drug|docetaxel|
12073244|NCT00058435|Biological|abagovomab|
12073245|NCT00058422|Biological|darbepoetin alfa|
12073246|NCT00058422|Biological|filgrastim|
12073247|NCT00058422|Biological|rituximab|
12073248|NCT00058422|Drug|cyclophosphamide|
12073249|NCT00058422|Drug|doxorubicin hydrochloride|
12073250|NCT00058422|Drug|prednisone|
12073251|NCT00058422|Drug|vincristine sulfate|
12073252|NCT00058422|Radiation|indium In 111 ibritumomab tiuxetan|
12073253|NCT00058422|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12073254|NCT00058396|Biological|lumiliximab|
12073255|NCT00058370|Drug|cisplatin|
12073256|NCT00058370|Drug|lomustine|
12073257|NCT00058370|Drug|vincristine sulfate|
12073258|NCT00058370|Procedure|adjuvant therapy|
12073259|NCT00058370|Radiation|iodine I 131 monoclonal antibody 3F8|
12073260|NCT00058370|Radiation|radiation therapy|
12073261|NCT00058357|Drug|lidocaine|
12073262|NCT00058357|Other|placebo|
12073263|NCT00058331|Biological|epoetin alfa|
12073264|NCT00058318|Drug|capecitabine|Capecitabine will be given 625 mg/m^2 (1250 mg/m^2/day) by mouth twice a day on day 1-21 for every cycle (1 cycle =28 days) until disease progression
12073265|NCT00058318|Drug|gemcitabine hydrochloride|Gemcitabine will be given 900 mg/m^2 by intravenous infusion over 30 minutes on day 1, 8, and 15 for every cycle (1 cycle = 28 days) until disease progression.
12073266|NCT00058305|Drug|bryostatin 1|Given IV
12073267|NCT00058305|Drug|vincristine sulfate|Given IV
12073268|NCT00058305|Other|laboratory biomarker analysis|Correlative studies
12073269|NCT00058292|Biological|filgrastim|Given at a dose of 5 μg/kg, subcutaneously daily, beginning on Day 0 (stem cell transplant day) until white blood cells measure greater than 1500/ul.
12073270|NCT00058292|Biological|rituximab|Intravenous infusion of 250 mg/m2 on treatment days -22 and -14 (day 0 = stem cell transplant).
12073271|NCT00058292|Drug|Carmustine|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Carmustine is given at a dose of 300 mg/m2 intravenous infusion over a 2 hour period on treatment day -6 (Day 0 = stem cell transplant).
12073272|NCT00058292|Drug|cytarabine|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Cytarabine is given at a dose of 100 mg/m2 intravenous infusion over a 1 hour period, every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
12073273|NCT00058292|Drug|etoposide|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Etoposide is given at a dose of 100 mg/m2 intravenous infusion over a 2 hour period every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
12073274|NCT00058292|Drug|melphalan|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Melphalan is given at a dose of 140 mg/m2 as an intravenous infusion over a 1 hour period on treatment day -1 (Day 0 = stem cell transplant).
12073275|NCT00058292|Procedure|peripheral blood stem cell transplantation|On day 0, a minimum of 2.0 X 106 CD34+ cells/kg unselected peripheral blood progenitor cells (PBPC) will be reinfused following institutional guidelines for the reinfusion procedure.
12073276|NCT00058292|Radiation|yttrium Y 90 ibritumomab tiuxetan|Patients will receive 90Y2B8 at a variable dose on treatment day -14 (Day 0 = stell cell transplant). The initial dose calculated to deliver no more than 100 cGy to critical organs (liver, lung). Doses will be escalated based on cohort of enrollment.
12073277|NCT00058279|Biological|aldesleukin|
12073278|NCT00058279|Biological|ipilimumab|
12073279|NCT00058266|Dietary Supplement|genistein|Given orally
12073280|NCT00058266|Procedure|conventional surgery|Patients undergo surgery
12073281|NCT00058253|Drug|tanespimycin|Given IV
12073282|NCT00058253|Drug|docetaxel|Given IV
12073283|NCT00058240|Drug|alvocidib|Given IV
12073284|NCT00058227|Drug|alvocidib|Given IV
12073285|NCT00058227|Drug|fludarabine phosphate|Given IV
12073286|NCT00058227|Biological|rituximab|Given IV
12073287|NCT00058227|Other|pharmacological study|Correlative studies
12073288|NCT00058214|Drug|perifosine|Given orally
12073289|NCT00058214|Other|laboratory biomarker analysis|Correlative studies
12073290|NCT00058201|Drug|fluorouracil|Given IV
12073291|NCT00058201|Drug|gemcitabine hydrochloride|Given IV
12073292|NCT00058201|Drug|leucovorin calcium|Given IV
12073293|NCT00058201|Other|clinical observation|No intervention
12073294|NCT00058188|Dietary Supplement|cholecalciferol|Given orally
12073295|NCT00058188|Drug|calcium gluconate|Given orally
12073296|NCT00058188|Drug|zoledronic acid|Given IV
12073297|NCT00058149|Drug|gemcitabine hydrochloride|
12073298|NCT00058149|Drug|oxaliplatin|
12073299|NCT00058123|Drug|poly ICLC|
12073300|NCT00058097|Drug|tipifarnib|Given orally
12073301|NCT00058097|Radiation|radiation therapy|Undergo radiation therapy
12073302|NCT00058084|Drug|ixabepilone|Given IV
12073303|NCT00058084|Drug|mitoxantrone hydrochloride|Given IV
12073304|NCT00058084|Drug|prednisone|Given orally
12073305|NCT00058071|Drug|amifostine trihydrate|
12073306|NCT00058058|Procedure|MRI|Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.
12073307|NCT00058045|Biological|aldesleukin|
12073308|NCT00058045|Biological|recombinant human stem cell factor|
12073309|NCT00058032|Other|screening questionnaire administration|
12073310|NCT00058032|Procedure|annual screening|
12073311|NCT00058019|Drug|ixabepilone|Given IV
12073313|NCT00058006|Procedure|adjuvant therapy|
12073314|NCT00057993|Biological|trastuzumab|
12073315|NCT00057993|Drug|exemestane|
12073316|NCT00057980|Drug|celecoxib|
12073317|NCT00057980|Drug|epirubicin hydrochloride|
12073318|NCT00057967|Biological|alemtuzumab|Will be administered as a two-hour IV infusion with a target dose of 30 milligrams three times a week for a maximum of 12 weeks.
12073319|NCT00057954|Procedure|Extracorporeal Photopheresis|Day -7 to -4: Extracorporeal Photopheresis may be given as an outpatient therapy on two consecutive days any time between days -7 to -4. This must be performed on UVAR or XTS photopheresis machines (Therakos, Inc.) according to standard procedure as per manufacturer's guidelines.
12073320|NCT00057954|Drug|Pentostatin|Day -3, -2: Pentostatin 4 mg/m²/d by continuous IV infusion (Total dose = 8 mg/m²)
12073321|NCT00057954|Radiation|Total body irradiation (TBI)|Day -1: TBI 400 cGy total dose given in two 200cGy doses. Patients who have received TBI for a previous transplant or radiation as part of previous treatment for a lymphoid malignancy will receive only 200 cGy in 1 dose.
12073322|NCT00057954|Procedure|Allogeneic bone marrow transplantation|Day 0: Infusion of unmanipulated allogeneic bone marrow or stem cells. Minimum cell dose of 2 x 106 CD34 cells/kg recipient and no more than 10 x 10^6 CD34/kg
12073323|NCT00057954|Drug|Cyclosporin (CSA)|Cyclosporin A or tacrolimus will be administered according to institutional GVHD prophylaxis protocols. Therapeutic levels will be maintained and patients will be switched to oral agents when they can tolerate
12073324|NCT00057954|Drug|Mycophenolate mofetil (MMF)|At day 100 MMF will be introduced at a dose of 250 mg po BID and cyclosporine or tacrolimus will be tapered according to the discretion of the investigator. The dosage will be escalated to a maximum of 2 g/d at the discretion of the attending physician and will be tapered and discontinued at 12 months if there is no active cGVHD. Doses should be given on an empty stomach
12073325|NCT00057954|Drug|Methotrexate (MTX)|"The dose of Methotrexate is based on the corrected ideal body weight for patients with > 33% above ideal weight.
~Day +1 MTX 15 mg/m² IV push; Day +3 MTX 10 mg/m² IV push (May be omitted if patient develops mouth sores.)"
12073326|NCT00057941|Drug|anastrozole|Given orally
12073327|NCT00057941|Drug|gefitinib|Given orally
12073328|NCT00057941|Drug|fulvestrant|Given intramuscularly
12073329|NCT00057941|Other|laboratory biomarker analysis|Correlative studies
12073330|NCT00057928|Drug|cisplatin|
12073331|NCT00057928|Drug|gemcitabine hydrochloride|
12073332|NCT00057928|Drug|paclitaxel|
12073333|NCT00057915|Biological|CEA peptide 1-6D|CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
12073334|NCT00057889|Biological|ipilimumab|
12073335|NCT00057876|Drug|Gemcitabine|"Induction: Patients receive the first cycle of gemcitabine 1000 mg/m^2 intravenously once per week for 6 weeks followed by 1 week rest.
~Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
12073336|NCT00057876|Radiation|radiation therapy|"Induction: Patients receive gemcitabine 600 mg/m^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks.
~Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy."
12073337|NCT00057863|Drug|Paclitaxel|Given IV
12073338|NCT00057863|Drug|Oxaliplatin|Given IV
12073339|NCT00057850|Drug|cisplatin|
12073340|NCT00057850|Drug|ixabepilone|
12073341|NCT00057837|Biological|G-CSF|G-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery > 10,000 dL.
12073342|NCT00057837|Drug|Cisplatin|Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.
12073343|NCT00057837|Drug|Etoposide|Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.
12073344|NCT00057837|Drug|Irinotecan|50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).
12073345|NCT00057837|Drug|Topotecan|Topotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).
12073346|NCT00057811|Drug|doxorubicin hydrochloride|Given IV, IT, or orally
12073347|NCT00057811|Drug|cyclophosphamide|Given IV
12073348|NCT00057811|Drug|methotrexate|Given IV or IT
12073349|NCT00057811|Drug|rasburicase|Given IV
12073350|NCT00057811|Drug|leucovorin calcium|Given IV or orally
12073351|NCT00057811|Drug|prednisone|Given IV or orally
12073352|NCT00057811|Drug|methylprednisolone|Given IV or orally
12073353|NCT00057811|Biological|filgrastim|Given subcutaneously
12073354|NCT00057811|Biological|rituximab|Given IV
12073355|NCT00057811|Drug|cytarabine|Given IT
12073356|NCT00057811|Drug|etoposide|Given IV
12073357|NCT00057811|Drug|vincristine sulfate|Given IV
12073358|NCT00057811|Drug|hydrocortisone sodium succinate|Given IT
12073359|NCT00057811|Other|laboratory biomarker analysis|Correlative studies
12073360|NCT00057798|Drug|gemcitabine hydrochloride|
12073361|NCT00057798|Drug|vinorelbine ditartrate|
12073362|NCT00057798|Genetic|cytogenetic analysis|
12073363|NCT00057798|Genetic|loss of heterozygosity analysis|
12073364|NCT00057798|Genetic|microarray analysis|
12073365|NCT00057798|Procedure|conventional surgery|
12073366|NCT00057798|Procedure|neoadjuvant therapy|
12073367|NCT00057785|Drug|cisplatin|100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127
12073368|NCT00057785|Drug|fluorouracil|1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130
12073419|NCT00057473|Drug|carboplatin + irinotecan|Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.
12073369|NCT00057785|Radiation|Intensity modulated radiation therapy|The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume [CTV] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.
12073370|NCT00057759|Drug|sildenafil citrate|
12073371|NCT00057759|Other|Placebo|Placebo
12073372|NCT00057746|Radiation|Prophylactic cranial irradiation, 2.5 Gy fx|Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy
12073373|NCT00057746|Radiation|Prophylactic cranial irradiation, 2.0 Gy fx|Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy
12073374|NCT00057746|Radiation|Prophylactic cranial irradiation, 1.5 Gy fx|Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy
12073375|NCT00057733|Procedure|psychosocial assessment and care|
12073376|NCT00057733|Procedure|quality-of-life assessment|
12073377|NCT00030368|Drug|bortezomib|Given IV
12073378|NCT00030368|Drug|paclitaxel|Given IV
12073379|NCT00030368|Other|laboratory biomarker analysis|Correlative studies
12073380|NCT00023673|Drug|carboplatin|
12073381|NCT00023673|Drug|paclitaxel|
12073382|NCT00023673|Radiation|three-dimensional conformal radiation therapy|
12073383|NCT00004079|Drug|SarCNU|Given PO
12073384|NCT00004079|Other|pharmacological study|Correlative studies
12073385|NCT00004079|Other|laboratory biomarker analysis|Correlative studies
12073386|NCT00057720|Drug|TLK286 HCl for injection|
12073387|NCT00057720|Drug|topotecan hydrochloride for injection|
12073388|NCT00057720|Drug|doxorubicin HCl liposome injection|
12073389|NCT00057681|Drug|Lithium carbonate|Titrated until blood level is 1.1 to 1.3 mEq/L
12073390|NCT00057681|Drug|Valproate|Titrated until blood level is 111 to 125 ug/mL
12073391|NCT00057681|Drug|Risperidone|Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
12073392|NCT00057668|Behavioral|Multi-Setting Early Intervention|
12073393|NCT00057668|Behavioral|Community Intervention|
12073394|NCT00057642|Drug|Sertraline|
12073395|NCT00057642|Drug|Venlafaxine Extended Release|
12073396|NCT00057629|Behavioral|Prolonged Exposure (PE)|Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.
12073397|NCT00057629|Behavioral|Treatment as usual group therapy (TUGT)|TUGT is delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is not a formal, structured format for these groups; the counselors are sensitive to the participants' needs and follow their lead in terms of content covered in discussions and exercises. TUGT is conceptualized as supportive counseling and is based on the idea that members gain social support and information from one another.
12073398|NCT00057629|Behavioral|Supportive counseling (SC)|Supportive counseling is an individual therapy delivered in 10 weekly, 90 minute sessions. During this treatment, the therapist helps the patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The therapist uses active listening, encouragement of expression of feelings, praise, and encouragement. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these. No instructions for exposure are given.
12073399|NCT00057616|Drug|CC-5013|
12073400|NCT00057603|Procedure|Deep Brain Stimulation|Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.
12073401|NCT00057590|Behavioral|Care manager outreach and monitoring|
12073402|NCT00057577|Behavioral|Cognitive Therapy|CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
12073403|NCT00057577|Drug|Medications|Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
12073404|NCT00057564|Drug|A (Thalidomide + Dexamethasone)|Thalidomide 50mg/day + Dexamethasone 40mg
12073405|NCT00057564|Drug|B (Placebo + Dexamethasone)|Placebo + Dexamethasone 40mg
12073406|NCT00057707|Drug|Modafinil|Placebo 1 week-Wash out 1 week - Drug 1 week (or vice versa)
12073407|NCT00057707|Procedure|Functional MRI|
12073408|NCT00057707|Procedure|Neuropsychological Testing|
12073409|NCT00057551|Behavioral|Brief Supportive Psychotherapy|brief supportive psychotherapy
12073410|NCT00057551|Behavioral|CBASP|psychotherapy developed for chronic depression
12073411|NCT00057551|Drug|Medication Only|antidepressant medication
12073412|NCT00057538|Behavioral|Mantram Repetition|
12073413|NCT00057525|Biological|Anthrax|Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
12073414|NCT00057525|Biological|Alhdryogel or PBS|Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
12073415|NCT00057512|Drug|M4N|Dose escalation study of M4N administered intratumorally on days 1, 8 and 15. Dose escalated in cohorts on three weeks schedule to a target of 20 mg/cm3 tumor volume.
12073416|NCT00057499|Biological|IBC-VS01|IBC-VS01
12073417|NCT00057499|Biological|IBC-VS01 placebo|IBC-VS01 placebo
12073418|NCT00057486|Drug|IL-12|
12073617|NCT00055835|Procedure|neoadjuvant therapy|Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)
12073420|NCT00057473|Drug|irinotecan|Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.
12073421|NCT00057447|Drug|Interferon Gamma-1b|100 or 200 mcg, SQ, 3x per week
12073422|NCT00057447|Drug|Rituximab|375 mg per square meters, IV, 1x per week
12073423|NCT00057434|Drug|multivitamin|
12073424|NCT00057421|Drug|prednisolone|
12073425|NCT00057460|Drug|Talampanel|
12073426|NCT00057408|Drug|olanzapine (Zyprexa)|Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.
12073427|NCT00057408|Drug|Placebo|Matching Placebo
12073428|NCT00057395|Drug|Aroplatin (Liposomal NDDP, L-NDDP)|
12073429|NCT00057382|Drug|T138067 intravenous|
12073430|NCT00057382|Drug|doxorubicin intravenous|
12073431|NCT00057369|Drug|dalbavancin|
12073432|NCT00057356|Drug|conivaptan|IV
12073433|NCT00057356|Drug|placebo|IV
12073434|NCT00057343|Drug|Zevalin (ibritumomab tiuxetan)|
12073435|NCT00057343|Drug|Rituxan (rituximab)|
12073436|NCT00057330|Biological|HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine|the vaccine was administered intramuscularly in the non-dominant deltoid
12073437|NCT00057330|Biological|Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine|the vaccine was administered intramuscularly in the non-dominant deltoid
12073438|NCT00057317|Drug|Ro 205-2349|
12073439|NCT00057304|Drug|Insulin sensitizer|
12073440|NCT00057291|Behavioral|Responsive caregiving|Responsive caregiving consisted of operational circumstances and training of caregivers.
12073441|NCT00057031|Drug|DN-101 (calcitriol)|
12073442|NCT00057278|Drug|gabapentin|
12073443|NCT00057265|Drug|telbivudine or lamivudine|
12073444|NCT00057200|Procedure|Telephone, videophone care|
12073445|NCT00057187|Behavioral|Contracting, Prompting and Reinforcing|
12073446|NCT00057239|Drug|Radafaxine|
12073447|NCT00057226|Drug|Radafaxine|
12073448|NCT00057213|Drug|Radafaxine|
12073449|NCT00057174|Drug|Disease management of gastroesophageal reflux disease|
12073450|NCT00057161|Behavioral|Coordinated Representative Payeeship with Case Management|
12073451|NCT00057148|Procedure|massage treatment|
12073452|NCT00057135|Behavioral|Unit of use medication packaging|
12073453|NCT00057135|Behavioral|Mailed reminders to patient when medication refills are due|
12073454|NCT00057135|Behavioral|Note to Mental Health Provider when refill is overdue|
12073455|NCT00057135|Procedure|Aligning all prescriptions to fall due on same date|
12073456|NCT00057122|Drug|Isoniazid|300mg
12073457|NCT00057122|Drug|Rifapentine|Rifapentine 900 mg
12073458|NCT00057122|Drug|Rifampin|Rifampin 600 mg
12073459|NCT00057096|Procedure|On-site vs. referral methods of care|
12073460|NCT00057083|Other|Telemedicine Care|
12073461|NCT00057070|Procedure|Smoking cessation information, collection, and dissemination|
12073462|NCT00057057|Behavioral|Telephone Care|
12073463|NCT00057044|Behavioral|education and reminder|
12073464|NCT00057018|Procedure|Constraint-induced movement therapy|
12073465|NCT00057005|Drug|CAMPATH-1H|Day-8 through Day-6 according to institutional SOPs
12073466|NCT00057005|Drug|Anti-CD45|Day-5 400 μg/kg
12073467|NCT00057005|Drug|Ara-C|day-7 through day-5 3000 mg/m2 q 12h
12073468|NCT00057005|Drug|Cyclophosphamide|Day-7 through Day-6 45 mg/kg
12073469|NCT00057005|Drug|Mesna|Days -7 and -6 45 mg/kg divided into 5 doses
12073470|NCT00057005|Radiation|Total Body Irradiation|150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)
12073471|NCT00056992|Drug|ADI-PEG 20|
12073472|NCT00056979|Drug|CAMPATH-1H|
12073473|NCT00056979|Drug|Anti-CD45|
12073474|NCT00056979|Drug|FK506|
12073475|NCT00056979|Drug|Fludarabine|
12073476|NCT00056966|Drug|ANTI-CD45|400ug/kg Day-5 through Day-2
12073477|NCT00056966|Drug|CAMPATH-1H|Day -8 through Day -6 Dosed per Institutional SOP
12073478|NCT00056966|Drug|FK506|Day -2 through Day 30 dose adjusted to maintain level between 5-15 ng/ml.
12073479|NCT00056966|Drug|Fludarabine|Day-8 through Day-5 30 mg/m2
12073480|NCT00056966|Radiation|Total Body Irradiation|Day-1 single dose 450 cGy
12073481|NCT00056966|Procedure|Stem cell infusion|Patients will receive peripheral blood stem cells from a HLA matched or one antigen mismatched related or unrelated donor (target CD34+ cell count >2 x 106/kg). When peripheral stem cells are unavailable or insufficient, bone marrow (target mononuclear cell count >2 x 108/kg) will be substituted.
12073482|NCT00056953|Behavioral|Peer mentoring program|
12073483|NCT00056940|Behavioral|Stages of Change|
12073484|NCT00056940|Behavioral|Safety Check approach|
12073485|NCT00056927|Behavioral|Anti-smoking Socialization Program|
12073486|NCT00056875|Drug|recombinant human keratinocyte growth factor|
12073487|NCT00056836|Drug|rhuFab V2 (ranibizumab)|
12073488|NCT00056823|Drug|rhuFab V2 (ranibizumab)|
12073489|NCT00056862|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 90 mcg/week
12073490|NCT00056862|Drug|Peginterferon alfa-2a|180 mcg/week
12073491|NCT00056862|Drug|Ribavirin|800 mg/day
12073492|NCT00056810|Drug|4-aminopyridine (4-AP)|
12073493|NCT00056797|Biological|ALVAC HIV vaccine (vCP1452)|
12073494|NCT00056797|Drug|Interleukin-2|
12073495|NCT00056758|Biological|Autologous Dendritic Cell HIV Vaccination|
12073496|NCT00056745|Biological|TBC-3B|
12073497|NCT00056693|Drug|Sunitinib|Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
12073498|NCT00056680|Behavioral|Psychoeducational video|
12073499|NCT00056680|Behavioral|Infant massage|
12073500|NCT00056680|Behavioral|Brazelton Neonatal Behavioral Assessment Scale|
12073546|NCT00056303|Behavioral|Attachment and Biobehavioral Catch-up|Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.
12073501|NCT00056667|Behavioral|Relaxation response and cognitive behavioral therapy|The cognitive behavioral therapy program wwill incorporate relaxation training, a modified version of the RA treatment program developed by Bradley et al (1987) and shown to be effective. The cognitive behavioral techniques include problem solving, relabeling, enhanced awareness of pain behaviors, and attention refocusing. The RR component includes instruction in diaphragmatic breathing along with progressive skeletal muscle relaxation. The intervention will be modified from the original program in that neither biofeedback training nor participation of family members will be included. Consequently, the number of weekly group sessions will be reduced from 14 to 12. Homework will be given at the end of each session, to be completed and brought in for review to the next session.
12073502|NCT00056667|Behavioral|Relaxation response|The relaxation response (RR) consists of a set of integrated physiological changes elicited when a participant engages in the repetitive mental action of focusing on a word, phrase, or image, while passively ignoring distracting thoughts. These changes include decreased oxygen consumption, heart rate, arterial blood pressure, respiratory rate, and arterial blood lactate, along with slight increases in skeletal muscle blood flow. The long-term physiologic changes of participants eliciting the relaxation response are consistent with reduced norepinephrine end organ responsivity. These latter changes provide a plausible psychophysiological mechanism for longer-term actions of the RR.
12073503|NCT00056667|Other|RA education|RA education programs have been widely used to supplement routine medical care. They have been found to be of modest benefit, particularly in terms of knowledge about the condition and its treatment. The long-term effects on pain and level of function are less. When used as an attention control, such educational programs have been found to be as credible and as well attended as the active experimental treatment (Professor Francis Keefe, Personal Communication). In this study, patients randomized to the control condition will receive 8 weekly sessions of RA education, in groups of 6-10 patients each, using portions of the Arthritis Self-Management Program and incorporating printed and videotaped materials available from the Arthritis Foundation.
12073504|NCT00056654|Drug|Leuprolide acetate|45 mg Intramuscular injection 6 month depot formulation
12073505|NCT00056641|Drug|tipranavir|
12073506|NCT00056641|Drug|ritonavir|
12073507|NCT00056641|Drug|saquinavir|
12073508|NCT00056641|Drug|amprenavir|
12073509|NCT00056641|Drug|lopinavir|
12073510|NCT00056706|Procedure|Transient deafferentation|
12073511|NCT00056628|Device|The COGNIShunt® System|
12073512|NCT00056589|Drug|catridecacog|Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).
12073513|NCT00056576|Drug|Zonisamide|
12073514|NCT00056563|Device|Bilateral Deep Brain Stimulation|The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial.
12073515|NCT00056563|Other|best medical therapy|"Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
12073516|NCT00056550|Biological|Recombinant Human Antithrombin (rhAT)|Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
12073517|NCT00056537|Drug|ABR-217620|Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles
12073518|NCT00056524|Drug|AVP-923|
12073519|NCT00056511|Drug|Fresh garlic or garlic supplements|
12073520|NCT00056498|Drug|Placebo|Placebo capsule daily for 16 weeks
12073521|NCT00056498|Drug|Risperdal|Risperdal 4 mg per day for 16 weeks
12073522|NCT00056485|Behavioral|Pleasant Events-Based Behavioral Intervention|
12073523|NCT00056472|Drug|Olanzapine|10-20mg/day
12073524|NCT00056472|Drug|Sertraline|150-200mg/day
12073525|NCT00056472|Other|placebo|tablet that ressembles sertraline but contains no medication
12073526|NCT00012454|Drug|E-Selectin nasal spray|
12073527|NCT00056459|Drug|Vatalanib|
12073528|NCT00056446|Drug|Vatalanib|
12073529|NCT00056433|Drug|Hydroxyurea|
12073530|NCT00056433|Drug|L-Arginine|
12073531|NCT00056433|Drug|Sildenafil|
12073532|NCT00056407|Drug|Dutasteride|After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.
12073533|NCT00056407|Drug|Placebo|After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.
12073534|NCT00056394|Behavioral|Comprehensive Coping Skills Training|10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.
12073535|NCT00056394|Behavioral|Arthritis Education Sessions|10 weekly, 80-minute treatment sessions, followed by a series of six biweekly follow-up telephone calls. Participants will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection.
12073536|NCT00056394|Behavioral|Standard Care|Usual care from participants' rheumatologists but no treatment sessions.
12073537|NCT00056381|Drug|Anidulafungin|
12073538|NCT00056368|Drug|Anidulafungin|
12073539|NCT00056368|Drug|Fluconazole|
12073540|NCT00056329|Drug|Vitamin E|1,000 international units twice daily for three years
12073541|NCT00056329|Drug|multivitamin|once daily for three years
12073542|NCT00056329|Drug|Placebo|Placebo twice daily for three years
12073543|NCT00056355|Drug|UVADEX and UVAR XTS Photopheresis System|
12073544|NCT00056316|Behavioral|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
12073545|NCT00056316|Behavioral|Behavioral Skills Training: Experimental|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
12073547|NCT00056303|Behavioral|Developmental Education for Families|Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
12073548|NCT00056290|Biological|VEGF|3 sets of injections, at 2 week intervals
12073549|NCT00056290|Biological|VEGF|3 sets of injections, at 2 week intervals
12073550|NCT00056277|Drug|lamotrigine|
12073551|NCT00056264|Drug|Infliximab|
12073552|NCT00056251|Procedure|H&P; ECG; Blood tests; voiding diary; Cystoscopy|
12073553|NCT00056238|Drug|NC-758 (Anti amyloidotic [Aß] agent)|
12073554|NCT00056225|Drug|Folate|
12073555|NCT00056225|Drug|Vitamin B6|
12073556|NCT00056225|Drug|Vitamin B12|
12073557|NCT00056212|Behavioral|Yoga|
12073558|NCT00056212|Behavioral|Exercise|
12073559|NCT00056173|Drug|GTI-2040|
12073560|NCT00056199|Drug|EYE001|
12073561|NCT00056160|Drug|CC-5013|Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.
12073562|NCT00056160|Drug|Dexamethasone|Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
12073563|NCT00056147|Drug|denufosol tetrasodium (INS37217)|
12073564|NCT00056134|Biological|Dendritic cell vaccine plus denileukin difitox|
12073565|NCT00056095|Biological|therapeutic allogeneic lymphocytes|
12073566|NCT00056095|Drug|cyclophosphamide|
12073567|NCT00056095|Drug|cyclosporine|
12073568|NCT00056095|Drug|fludarabine phosphate|
12073569|NCT00056095|Procedure|allogeneic bone marrow transplantation|
12073570|NCT00056095|Procedure|peripheral blood stem cell transplantation|
12073571|NCT00056082|Drug|celecoxib|Celecoxib daily for 12 months
12073572|NCT00056069|Other|questionnaire administration|Participants complete questionnaires regarding caregiver demands and family information over 25-30 minutes within 3-4 months of the initiation of the child's treatment and at the completion of the first year of the child's treatment.
12073573|NCT00056056|Drug|bexarotene|The recommended initial dosage of Bexarotene (75 mg Bexarotene capsules to be administered according to body surface area) for patients entered in this trial is 300 mg/m2 /once a day, taken orally, till CCR, PD, unacceptable toxicity, 16 weeks of treatment, whichever comes first
12073574|NCT00056056|Drug|methoxypsoralen|The dose of methoxypsoralen, as conventional capsules or liquid-filled capsules, is based on the patient's weight. The standard dose of 0.6 mg/kg will be given to all patients three times weekly - Increasing dose of PUVA according to a set protocol after a Minimal Phototoxic Dose (MPD) testing.
12073575|NCT00056056|Procedure|UV light therapy|Initial UVA light exposure times should be based on the minimal phototoxic dose (MPD) for the specific light source being used. MPD can be determined by irradiating several skin areas 2 cm in diameter with varying light exposure times and determining the exposure time that produces erythema at 72 hours. The initial dose of UVA administered will be 70% of the MPD. The dose of UVA for the subsequent UVA sessions will be increased according to a standard protocol consisting of 20% increments with each successive treatment session depending on the presence of erythema.
12073576|NCT00056030|Biological|cetuximab|
12073577|NCT00056030|Drug|fluorouracil|
12073578|NCT00056030|Drug|leucovorin calcium|
12073579|NCT00056030|Drug|oxaliplatin|
12073580|NCT00056004|Drug|zileuton|
12073581|NCT00055991|Drug|bexarotene|This drug is a retinoid. The anti-tumor action of retinoids, as well as their potential in chemoprevention, supports the need to further identify the spectrum of responsive tumors, to identify the molecular mechanisms associated with retinoid action, and to identify and develop new retinoids that have unique properties and an improved therapeutic index.
12073582|NCT00055978|Drug|celecoxib|Given orally. 400mg twice daily for 6 months.
12073583|NCT00055978|Other|placebo|Given orally
12073584|NCT00055965|Drug|carboplatin|
12073585|NCT00055965|Drug|cisplatin|
12073586|NCT00055965|Drug|gemcitabine hydrochloride|
12073587|NCT00055952|Drug|exatecan mesylate|
12073588|NCT00055939|Drug|exatecan mesylate|
12073589|NCT00055926|Drug|CP-724,714|
12073590|NCT00055913|Biological|bevacizumab|Given IV
12073591|NCT00055913|Drug|erlotinib hydrochloride|Given orally
12073592|NCT00055913|Other|laboratory biomarker analysis|Correlative studies
12073593|NCT00055887|Drug|carboplatin|
12073594|NCT00055887|Drug|cisplatin|
12073595|NCT00055887|Drug|efaproxiral|
12073596|NCT00055887|Drug|gemcitabine hydrochloride|
12073597|NCT00055887|Drug|paclitaxel|
12073598|NCT00055887|Drug|vinorelbine ditartrate|
12073599|NCT00055887|Procedure|radiation therapy|
12073600|NCT00055874|Biological|recombinant interferon alfa|
12073601|NCT00055874|Drug|cytarabine|
12073602|NCT00055874|Drug|hydroxyurea|
12073603|NCT00055874|Drug|imatinib mesylate|
12073604|NCT00055874|Procedure|allogeneic bone marrow transplantation|
12073605|NCT00055874|Procedure|autologous bone marrow transplantation|
12073606|NCT00055874|Procedure|peripheral blood stem cell transplantation|
12073607|NCT00055861|Biological|bevacizumab|Given IV
12073608|NCT00055861|Drug|docetaxel|Given IV
12073609|NCT00055861|Other|laboratory biomarker analysis|Correlative studies
12073610|NCT00055848|Genetic|cytogenetic analysis|
12073611|NCT00055848|Genetic|gene mapping|
12073612|NCT00055848|Genetic|microarray analysis|
12073613|NCT00055835|Drug|carboplatin|*AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
12073614|NCT00055835|Drug|cisplatin|75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days)
12073615|NCT00055835|Drug|gemcitabine hydrochloride|800 mg/m2, IV, over 30 minutes; given on Days 1 & 8, q 21 days, for a maximum of 3 cycles (1 cycle = 21 days)
12073616|NCT00055835|Drug|paclitaxel|200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
12073618|NCT00055835|Radiation|radiation therapy|Radiation treatments will be delivered once daily. Treatment will be given 5 days per week at a dose of 180 to 200 cGy per day. All fields will be treated everyday.
12073619|NCT00055822|Biological|oblimersen sodium|
12073620|NCT00055822|Drug|fluorouracil|
12073621|NCT00055822|Drug|leucovorin calcium|
12073622|NCT00055822|Drug|oxaliplatin|
12073623|NCT00055809|Biological|PEG-interferon alfa-2b|Given SC
12073624|NCT00055809|Biological|bevacizumab|Given IV
12073625|NCT00055809|Other|laboratory biomarker analysis|Optional correlative studies
12073626|NCT00055783|Biological|apolizumab|
12073627|NCT00055770|Drug|erlotinib hydrochloride|Given orally
12073628|NCT00055770|Drug|docetaxel|Given IV
12073629|NCT00055770|Other|laboratory biomarker analysis|Correlative studies
12073630|NCT00055770|Other|pharmacological study|Correlative studies
12073631|NCT00055757|Drug|tipifarnib|Given orally
12073632|NCT00055757|Drug|cisplatin|Given IV
12073633|NCT00055757|Drug|gemcitabine hydrochloride|Given IV
12073634|NCT00055757|Other|laboratory biomarker analysis|Correlative studies
12073635|NCT00055731|Drug|bicalutamide|
12073636|NCT00055731|Drug|buserelin|
12073637|NCT00055731|Drug|cyproterone acetate|
12073638|NCT00055731|Drug|docetaxel|
12073639|NCT00055731|Drug|estramustine phosphate sodium|
12073640|NCT00055731|Drug|flutamide|
12073641|NCT00055731|Drug|goserelin acetate|
12073642|NCT00055731|Drug|leuprolide acetate|
12073643|NCT00055731|Drug|nilutamide|
12073644|NCT00055731|Drug|triptorelin|
12073645|NCT00055731|Procedure|conventional surgery|
12073646|NCT00055731|Procedure|neoadjuvant therapy|
12073647|NCT00055731|Radiation|radiation therapy|
12073648|NCT00055718|Dietary Supplement|silymarin|
12073649|NCT00055705|Biological|PV701|
12073650|NCT00055692|Biological|bevacizumab|Given orally
12073651|NCT00055679|Drug|cyclophosphamide|
12073652|NCT00055679|Drug|epirubicin hydrochloride|
12073653|NCT00055679|Drug|fluorouracil|
12073654|NCT00055666|Drug|beclomethasone dipropionate|
12073655|NCT00055653|Biological|anti-thymocyte globulin|
12073656|NCT00055653|Biological|filgrastim|
12073657|NCT00055653|Drug|busulfan|
12073658|NCT00055653|Drug|cyclophosphamide|
12073659|NCT00055653|Drug|cyclosporine|
12073660|NCT00055653|Drug|fludarabine phosphate|
12073661|NCT00055653|Drug|melphalan|
12073662|NCT00055653|Drug|methylprednisolone|
12073663|NCT00055653|Procedure|umbilical cord blood transplantation|
12073664|NCT00055653|Radiation|radiation therapy|
12073665|NCT00055640|Biological|rituximab|Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
12073666|NCT00055640|Drug|cyclophosphamide|Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
12073667|NCT00055640|Drug|doxorubicin hydrochloride|Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
12073668|NCT00055640|Drug|prednisone|Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
12073669|NCT00055640|Drug|vincristine sulfate|Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
12073670|NCT00055640|Genetic|microarray analysis|genetic testing
12073671|NCT00055614|Drug|topotecan hydrochloride|
12073672|NCT00055614|Procedure|adjuvant therapy|
12073673|NCT00055601|Drug|cisplatin|Induction: 15 mg/m2 as a 60-minute infusion on days 1, 2, 3, 8, 9, 10, 15, 16, and 17; Consolidation: 15 mg/m2 as a 60-minute infusion on days 1, 2, 8, and 9; Adjuvant: 35 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.
12073674|NCT00055601|Drug|fluorouracil|Induction: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 15, 16, and 17; Consolidation: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 8, 9, and 10.
12073675|NCT00055601|Drug|paclitaxel|Induction: 50 mg/m2 as a 60-minute infusion on days 1, 8, and 15; Consolidation: 50 mg/m2 as a 60-minute infusion on days 1 and 8; Adjuvant: 50 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.
12073676|NCT00055601|Radiation|radiation therapy|Induction: External beam irradiation, 1.6 Gy, will be given to the pelvis in the first treatment followed by an interfraction period of at least 4-6 hours. During the second treatment, 1.5 Gy will be delivered to the whole bladder for the first five sessions (7.5 Gy) then to the tumor plus a margin for eight sessions (12. Gy). Consolidation: Consolidation therapy will start 7-14 days following a cystoscopic re-evaluation demonstrating a complete response to the induction therapy. 1.5 Gy (per fraction) will be given to the pelvis in two treatment fractions per day, with an interfraction period of at least 4-6 hours.
12073677|NCT00055601|Drug|Gemcitabine|Adjuvant: 1000 mg/m2 over 30-60 minutes on days 1 and 8 of each 21-day cycle for 4 cycles.
12073678|NCT00055601|Procedure|Radical cystectomy|Operable patients with pT1 or worse tumor response on re-evaluation following induction therapy will have radical cystectomy.
12073679|NCT00022139|Drug|carboplatin|
12073680|NCT00022139|Drug|fluorouracil|
12073681|NCT00022139|Drug|paclitaxel|
12073682|NCT00022139|Procedure|conventional surgery|
12073683|NCT00022139|Radiation|radiation therapy|
12073684|NCT00005028|Drug|bryostatin 1|
12073685|NCT00005028|Drug|paclitaxel|
12073686|NCT00055588|Procedure|Locomotor training|
12073687|NCT00055575|Drug|Transderm Scopolamine|
12073688|NCT00055562|Drug|CC 5013|
12073689|NCT00055536|Drug|natalizumab|
12073690|NCT00055523|Drug|Adalimumab (D2E7)|
12073691|NCT00055549|Drug|Dextromethorphan|
12073692|NCT00055549|Drug|Lorazepam|
12073693|NCT00055510|Drug|BO-653|
12073694|NCT00055497|Biological|Double-blind (DB) adalimumab placebo|Double-blind nonactive matching subcutaneous injection
12073695|NCT00055497|Biological|DB adalimumab 40 mg eow|Double-blind adalimumab 40 mg every other week by subcutaneous injection
12073696|NCT00055497|Biological|DB adalimumab 40 mg ew|Double-blind adalimumab 40 mg every week by subcutaneous injection
12073950|NCT00053898|Radiation|Radiation Therapy|Adjuvant radiation therapy
12073697|NCT00055497|Biological|OL adalimumab 40 mg|Open-label adalimumab every other week or every week by subcutaneous injection
12073698|NCT00055484|Drug|zonisamide|
12073699|NCT00055471|Drug|ZD4054 10 mg|1 x 10 mg oral tablets once daily
12073700|NCT00055471|Drug|ZD4054 15 mg|1 x 10 mg + 2 x 2.5 mg oral tablets once daily
12073701|NCT00055471|Drug|ZD4054 22.5 mg|2 x 10 mg + 2 x 2.5 mg oral tablets once daily
12073702|NCT00055445|Drug|IdB 1016|
12073703|NCT00055432|Drug|Gemzar and Alimta|
12073704|NCT00055419|Biological|Cetuximab|400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression
12073705|NCT00055393|Drug|Bupropion|18 subjects in this randomly controlled double blind study received bupropion.
12073706|NCT00055393|Drug|Placebo|21 subjects received Placebo.
12073707|NCT00055380|Procedure|Oral cytobrushing|
12073708|NCT00055367|Drug|natalizumab|
12073709|NCT00055354|Procedure|Acupuncture|
12073710|NCT00055354|Behavioral|Cognitive Behavioral Therapy|
12073711|NCT00055341|Drug|Peginterferon alfa-2a|
12073712|NCT00055341|Drug|Ribavirin|
12073713|NCT00055328|Behavioral|Problem-Solving Treatment for Primary Care|
12073714|NCT00055315|Behavioral|Systems Training for Emotional Predictability and Problem Solving (STEPPS)|STEPPS is a 20-week, manual-based, psychoeducational group treatment that combines skills training with cognitive-behavioral techniques. It includes a systems component to train family members, friends, and significant others.
12073715|NCT00055315|Behavioral|Treatment As Usual (TAU)|
12073716|NCT00055302|Drug|Arimidex 1 mg|Arimidex (anastrozole) 1mg once daily by mouth
12073717|NCT00055263|Drug|DN-101|
12073718|NCT00055250|Drug|Gemcitabine|
12073719|NCT00055250|Drug|LY293111|
12073720|NCT00055250|Drug|placebo|
12073721|NCT00055237|Biological|Bevacizumab|15 mg/kg day intravenously on day 1, day 8, then every 3 weeks.
12073722|NCT00055224|Device|Acoustic startle|Threat condition
12073723|NCT00055224|Device|Electric Shock|Threat condition
12073724|NCT00055198|Drug|daptomycin|
12073725|NCT00055185|Drug|CD4-IgG2 (PRO 542)|
12073726|NCT00055146|Drug|ONTAK|
12073727|NCT00055133|Drug|Micellar Paclitaxel for Injection|
12073728|NCT00055159|Procedure|Pulse-sprayed injection of recombinant tissue plasminogen activator (rtPA)|
12073729|NCT00055120|Drug|Emtricitabine/tenofovir disoproxil fumarate|
12073730|NCT00055120|Drug|Lopinavir/ritonavir|
12073731|NCT00055120|Drug|Stavudine|
12073732|NCT00055107|Drug|Nitazoxanide|
12073733|NCT00055081|Behavioral|Critical Time Intervention|
12073734|NCT00055068|Behavioral|Cognitive Behavioral Therapy (CBT)|
12073735|NCT00055068|Behavioral|Relaxation Training|
12073736|NCT00055042|Drug|Vitamin E|
12073737|NCT00054977|Drug|GM-CT-01|IV infusion over 30 minutes of 6 Dosages escalated from 30 to 280 mg/m2, given for 4 consecutive days in a 28 days cycle.
12073738|NCT00054977|Drug|5-fluorouracil|IV infusion over 30 minutes at Dosage of 500 mg/m2, given in-combination with GM-CT-01, for 4 consecutive days in a 28 days cycle.
12073739|NCT00054964|Drug|Albuterol HFA-BOI|Albuterol HFA breath operated inhaler, 90 mcg/sprau
12073740|NCT00054964|Drug|Albuterol HFA-MDI|Albuterol HFA multi-dose inhaler
12073741|NCT00054951|Drug|MTC-DOX for Injection|
12073742|NCT00054938|Drug|pravastatin|
12073743|NCT00054938|Drug|aspirin|
12073744|NCT00054938|Drug|ramipril|
12073745|NCT00054938|Drug|Vitamins: B6, B12, and folate|
12073746|NCT00054938|Behavioral|heart health educational program|
12073747|NCT00054925|Behavioral|Personal contact (PC)|This arm uses brief, individual contacts on a monthly basis which emphasize core elements of weight maintenance. Monthly contacts with an interventionist occur for 30 months after the end of Phase I. Face-to-face contacts occur approximately every four months (e.g., three annually), with telephone contacts occurring every month between FTF contacts.
12073748|NCT00054925|Behavioral|Interactive technology (IT)|The website utilizes collaborative goal setting and problem-solving strategies to identify contingent action plans for perceived obstacles to success. In order to tailor the intervention to the needs of the participant, the action plan can be updated anytime and as frequently as desired by the individual. Participants are encouraged to input data on weight, food records, physical activity, and goals on a weekly basis. Participants are not restricted to logging on to the website only once a week. Rather, participants have the option of logging on to the website to enter data, communicate with other participants, or to seek other information, as frequently as they wish.
12073749|NCT00054912|Biological|EP2101|
12073750|NCT00054899|Biological|EP2101|
12073751|NCT00054886|Drug|SU-011,248|
12073752|NCT00054873|Drug|tezacitabine|
12073753|NCT00054873|Drug|5-fluorouracil|
12073754|NCT00054860|Biological|EP HIV-1090|
12073755|NCT00054847|Procedure|saphenous vein graft|Saphenous vein harvested from the arm is used as a conduit for CABG.
12073756|NCT00054847|Procedure|radial artery graft|Radial artery harvested from the arm is used as a conduit for CABG.
12073757|NCT00054834|Drug|hLL2 (epratuzumab)|
12073758|NCT00054821|Procedure|Ankle distraction permitting motion|External fixator is applied to ankle joint for 85 - 95 days; ankle motion is permitted
12073759|NCT00054821|Procedure|Ankle distraction without motion|External fixator is applied to ankel joint for 85 - 95 days; ankle motion is not permitted
12073760|NCT00054808|Drug|gallium nitrate|
12073761|NCT00054795|Drug|Motexafin Gadolinium|
12073762|NCT00054730|Drug|CX516 (Ampalex®)|
12073763|NCT00054756|Drug|TRH (Thyrotropin Releasing Hormone)|
12073764|NCT00054743|Procedure|Blood draw|
12073765|NCT00054717|Drug|Tipranavir|
12073766|NCT00054717|Drug|Ritonavir(r)|
12073767|NCT00054717|Drug|Comparator Protease Inhibitor (CPI)|
12073768|NCT00054704|Drug|Riluzole|Riluzole
12073769|NCT00054704|Drug|Placebo|Placebo
12073770|NCT00054691|Drug|Iressa|250 mg by mouth daily
12073771|NCT00054678|Drug|MyoCell™|
12073772|NCT00054678|Device|MyoCath™|
12073773|NCT00050531|Drug|Gleevec|400 mg orally twice daily.
12073774|NCT00050531|Drug|Peg-alpha interferon (Peg-Intron)|PEG-IFN 0.5 mcg/kg each week subcutaneously.
12073775|NCT00050531|Drug|Sargramostim (GM-CSF)|125 mcg/m^2 three times per week subcutaneously.
12073776|NCT00054665|Drug|PS-341|1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
12073777|NCT00054665|Drug|Etoposide|50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion. Repeat cycle every 21 days.
12073778|NCT00054665|Drug|Doxorubicin|10 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
12073779|NCT00054665|Drug|Vincristine|0.4 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
12073780|NCT00054665|Drug|Cyclophosphamide|750 mg/m^2 day IV day 5 bolus. Repeat cycle every 21 days.
12073781|NCT00054665|Drug|Prednisone|60 mg/m^2 by mouth twice a day days 1-5. Repeat cycle every 21 days.
12073782|NCT00054665|Drug|Filgrastim|300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days.
12073783|NCT00054639|Biological|oblimersen sodium|Given IV
12073784|NCT00054639|Biological|rituximab|Given IV
12073785|NCT00054639|Other|laboratory biomarker analysis|Correlative studies
12073786|NCT00054626|Drug|cisplatin|
12073787|NCT00054626|Drug|gemcitabine hydrochloride|
12073788|NCT00054626|Procedure|adjuvant therapy|
12073789|NCT00054613|Drug|Methoxsalen|
12073790|NCT00054613|Procedure|Extracorporeal Photopheresis|
12073791|NCT00054600|Drug|Methoxsalen|
12073792|NCT00054600|Procedure|Extracorporeal Photopheresis|
12073793|NCT00054587|Biological|Trastuzumab|8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
12073794|NCT00054587|Drug|Cyclophosphamide|500 mg/m², D1 and every 3 weeks
12073795|NCT00054587|Drug|docetaxel|on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks
12073796|NCT00054587|Drug|Epirubicin|100 mg/m², D1 and every 3 weeks
12073797|NCT00054587|Drug|Fluorouracil|500 mg/m², D1 and every 3 weeks
12073798|NCT00054574|Biological|panitumumab|
12073799|NCT00054561|Biological|recombinant interferon alfa|
12073800|NCT00054561|Dietary Supplement|vitamin E|
12073801|NCT00054561|Drug|isotretinoin|
12073802|NCT00054561|Procedure|adjuvant therapy|
12073803|NCT00054548|Biological|oblimersen sodium|Given IV
12073804|NCT00054548|Drug|paclitaxel|Given IV
12073805|NCT00054548|Other|laboratory biomarker analysis|Correlative studies
12073806|NCT00054548|Other|pharmacological study|Correlative studies
12073807|NCT00054535|Biological|aldesleukin|
12073808|NCT00054535|Biological|recombinant fowlpox-tyrosinase vaccine|
12073809|NCT00054535|Biological|vaccinia-tyrosinase vaccine|
12073810|NCT00054522|Dietary Supplement|calcitriol|
12073811|NCT00054522|Drug|dexamethasone|
12073812|NCT00054496|Drug|erlotinib hydrochloride|
12073813|NCT00054483|Drug|bortezomib|Given IV
12073814|NCT00054483|Other|laboratory biomarker analysis|Correlative studies
12073815|NCT00054483|Other|pharmacological study|Correlative studies
12073816|NCT00054470|Biological|trastuzumab|
12073817|NCT00054470|Drug|tipifarnib|
12073818|NCT00054457|Drug|capecitabine|
12073819|NCT00054457|Drug|docetaxel|
12073820|NCT00054444|Drug|Topotecan Hydrochloride Liposomes|Given IV
12073821|NCT00054444|Radiation|3-Dimensional Conformal Radiation Therapy|
12073822|NCT00054444|Drug|Cisplatin|Given IV
12073823|NCT00054431|Drug|imatinib mesylate|Given orally
12073824|NCT00054431|Drug|decitabine|Given IV
12073825|NCT00054431|Other|laboratory biomarker analysis|Correlative studies
12073826|NCT00054418|Dietary Supplement|calcium carbonate|calcium 600 mg daily administered orally for one year
12073827|NCT00054418|Dietary Supplement|vitamin D|vitamin D 400 U daily administered orally for one year
12073828|NCT00054418|Drug|risedronate sodium|risedronate 35 mg weekly administered orally
12073829|NCT00054418|Other|placebo|placebo tablet weekly administered orally for one year
12073830|NCT00054405|Biological|recombinant interleukin-12|Given IV
12073831|NCT00054405|Biological|aldesleukin|Given IV
12073832|NCT00054392|Drug|carboplatin|
12073833|NCT00054392|Drug|gemcitabine hydrochloride|
12073834|NCT00054392|Drug|paclitaxel|
12073835|NCT00054353|Drug|fludarabine phosphate|Given IV
12073836|NCT00054353|Drug|melphalan|Given IV
12073837|NCT00054353|Radiation|total-body irradiation|Undergo TBI
12073838|NCT00054353|Drug|mycophenolate mofetil|Given PO
12073839|NCT00054353|Drug|cyclosporine|Given PO
12073840|NCT00054353|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo reduced-intensity allogeneic PBSCT
12073841|NCT00054353|Procedure|peripheral blood stem cell transplantation|Undergo reduced-intensity allogeneic PBSCT
12073842|NCT00054353|Other|laboratory biomarker analysis|Correlative studies
12073843|NCT00054340|Biological|anti-thymocyte globulin|
12073844|NCT00054340|Drug|busulfan|
12073845|NCT00054340|Drug|cyclophosphamide|
12073846|NCT00054340|Drug|cyclosporine|
12073847|NCT00054340|Drug|methotrexate|
12073848|NCT00054340|Procedure|allogeneic bone marrow transplantation|
12073849|NCT00054340|Procedure|peripheral blood stem cell transplantation|
12073850|NCT00054327|Drug|busulfan|Given orally 1mg/kg/dose (or 40mg/m2/dose for young children)
12073851|NCT00054327|Drug|cyclophosphamide|Given IV
12073852|NCT00054327|Drug|cytarabine|Given IV
12073853|NCT00054327|Radiation|radiation therapy|Patients undergo total body irradiation
12073854|NCT00054327|Drug|Etoposide|infusion
12073855|NCT00054327|Procedure|Stem Cell Transfusion|
12073856|NCT00054314|Drug|ortataxel|
12073857|NCT00054301|Procedure|adjuvant therapy|
12073858|NCT00054301|Procedure|conventional surgery|Patients undergo excisional biopsy or surgery.
12073951|NCT00053885|Drug|PTK787/ZK 222584|oral
12073952|NCT00053872|Drug|cisplatin|
12073859|NCT00054301|Radiation|intraoperative radiation therapy|Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity.
12073860|NCT00054288|Drug|gemcitabine hydrochloride|
12073861|NCT00054288|Drug|irinotecan hydrochloride|
12073862|NCT00054275|Drug|docetaxel|Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.
12073863|NCT00054275|Drug|erlotinib hydrochloride|OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.
12073864|NCT00054262|Drug|T900607|
12073865|NCT00054249|Drug|T900607|
12073866|NCT00054236|Biological|anti-thymocyte globulin|anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1
12073867|NCT00054236|Biological|filgrastim|Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
12073868|NCT00054236|Drug|cyclophosphamide|cyclophosphamide IV over 2 hours on days -3 to -2
12073869|NCT00054236|Drug|fludarabine phosphate|fludarabine IV over 30 minutes on days -8 to -4
12073870|NCT00054236|Procedure|umbilical cord blood transplantation|Patients undergo multiple unit umbilical cord blood transplantation on days 0-1.
12073871|NCT00054236|Drug|methylprednisolone|Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
12073872|NCT00054223|Procedure|psychosocial assessment and care|
12073873|NCT00054210|Drug|carboplatin|
12073874|NCT00054210|Drug|paclitaxel|
12073875|NCT00054210|Drug|paclitaxel poliglumex|
12073876|NCT00054197|Drug|gemcitabine hydrochloride|
12073877|NCT00054197|Drug|paclitaxel poliglumex|
12073878|NCT00054197|Drug|vinorelbine tartrate|
12073879|NCT00054184|Drug|docetaxel|
12073880|NCT00054184|Drug|paclitaxel poliglumex|
12073881|NCT00054171|Drug|aminolevulinic acid hydrochloride|
12073882|NCT00054158|Drug|dexamethasone|
12073883|NCT00054158|Drug|doxorubicin hydrochloride|
12073884|NCT00054158|Drug|thalidomide|
12073885|NCT00054158|Drug|vincristine sulfate|
12073886|NCT00054145|Drug|perifosine|
12073887|NCT00054132|Biological|Bevacizumab|Given IV
12073888|NCT00054132|Drug|Erlotinib Hydrochloride|Given PO
12073889|NCT00054132|Other|Laboratory Biomarker Analysis|Correlative studies
12073890|NCT00054119|Drug|Cositecan|Given IV
12073891|NCT00054119|Other|Pharmacological Study|Correlative studies
12073892|NCT00054106|Drug|buserelin|
12073893|NCT00054106|Drug|custirsen sodium|
12073894|NCT00054106|Drug|flutamide|
12073895|NCT00054106|Procedure|conventional surgery|
12073896|NCT00054106|Procedure|neoadjuvant therapy|
12073897|NCT00054067|Drug|cisplatin|
12073898|NCT00054067|Procedure|adjuvant therapy|
12073899|NCT00054067|Procedure|conventional surgery|
12073900|NCT00054067|Radiation|brachytherapy|
12073901|NCT00054067|Radiation|radiation therapy|
12073902|NCT00054054|Drug|cisplatin|
12073903|NCT00054054|Drug|docetaxel|
12073904|NCT00054054|Drug|fluorouracil|
12073905|NCT00054054|Radiation|radiation therapy|
12073906|NCT00054041|Biological|HspE7|Given subcutaneously
12073907|NCT00054041|Procedure|therapeutic conventional surgery|Undergo large loop excision
12073908|NCT00054041|Other|laboratory biomarker analysis|Correlative studies
12073909|NCT00054028|Drug|suramin|Given IV
12073910|NCT00054028|Drug|paclitaxel|Given IV
12073911|NCT00054028|Other|pharmacological study|Correlative studies
12073912|NCT00054015|Drug|triapine|
12073913|NCT00054002|Procedure|adjuvant therapy|Lung surgery
12073914|NCT00054002|Procedure|conventional surgery|Lung surgery
12073915|NCT00054002|Drug|porfimer sodium|iv
12073916|NCT00053989|Biological|anti-thymocyte globulin|iv
12073917|NCT00053989|Biological|graft-versus-tumor induction therapy|iv
12073918|NCT00053989|Biological|sargramostim|iv
12073919|NCT00053989|Biological|therapeutic allogeneic lymphocytes|iv
12073920|NCT00053989|Drug|cyclophosphamide|injection
12073921|NCT00053989|Drug|fludarabine phosphate|iv
12073922|NCT00053989|Drug|methylprednisolone|oral
12073923|NCT00053989|Drug|mycophenolate mofetil|oral
12073924|NCT00053989|Drug|tacrolimus|oral
12073925|NCT00053989|Procedure|allogeneic bone marrow transplantation|iv
12073926|NCT00053989|Procedure|peripheral blood stem cell transplantation|iv
12073927|NCT00053989|Procedure|umbilical cord blood transplantation|iv
12073928|NCT00053976|Biological|Daclizumab|
12073929|NCT00053976|Drug|methylprednisolone|
12073930|NCT00053976|Drug|Placebo|
12073931|NCT00053963|Drug|romidepsin|Given IV
12073932|NCT00053950|Drug|pyrazoloacridine|Given IV
12073933|NCT00053950|Biological|filgrastim|Given IV or SC
12073934|NCT00053950|Procedure|autologous bone marrow transplantation|Undergo autologous bone marrow transplantation
12073935|NCT00053950|Procedure|peripheral blood stem cell transplantation|Undergo peripheral blood stem cell transplantation
12073936|NCT00053950|Other|laboratory biomarker analysis|Correlative studies
12073937|NCT00053950|Other|pharmacological study|Correlative studies
12073938|NCT00053937|Drug|pirfenidone|
12073939|NCT00053924|Drug|perifosine|
12073940|NCT00053911|Drug|anastrozole|
12073941|NCT00053911|Drug|cyclophosphamide|
12073942|NCT00053911|Drug|docetaxel|
12073943|NCT00053911|Drug|epirubicin hydrochloride|
12073944|NCT00053911|Drug|fluorouracil|
12073945|NCT00053911|Drug|goserelin acetate|
12073946|NCT00053911|Drug|tamoxifen citrate|
12073947|NCT00053911|Procedure|adjuvant therapy|
12073948|NCT00053898|Drug|anastrozole|1 mg/day and placebo for 5 years
12073949|NCT00053898|Drug|tamoxifen citrate|20 mg/day and placebo for 5 years
12073953|NCT00053872|Drug|lomustine|
12073954|NCT00053872|Drug|vincristine sulfate|
12073955|NCT00053872|Procedure|adjuvant therapy|
12073956|NCT00053872|Radiation|radiation therapy|
12073957|NCT00053846|Drug|buspirone hydrochloride|The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
12073958|NCT00053846|Drug|Placebo|Placebo
12073959|NCT00053833|Drug|irinotecan|
12073960|NCT00053820|Biological|aldesleukin|
12073961|NCT00053820|Biological|recombinant interferon alfa|
12073962|NCT00053820|Drug|fluorouracil|
12073963|NCT00053807|Biological|aldesleukin|
12073964|NCT00053807|Biological|recombinant interferon alfa|
12073965|NCT00053807|Drug|fluorouracil|
12073966|NCT00053807|Procedure|adjuvant therapy|
12073967|NCT00053794|Drug|perifosine|
12073968|NCT00053781|Drug|perifosine|
12073969|NCT00053768|Biological|filgrastim|
12073970|NCT00053768|Drug|EPOCH regimen|
12073971|NCT00053768|Drug|cyclophosphamide|
12073972|NCT00053768|Drug|doxorubicin hydrochloride|
12073973|NCT00053768|Drug|etoposide|
12073974|NCT00053768|Drug|prednisone|
12073975|NCT00053768|Drug|vincristine sulfate|
12073976|NCT00053768|Radiation|radiation therapy|
12073977|NCT00053716|Drug|Liprostin [liposomal Prostaglandin E1]|
12073978|NCT00045123|Drug|tarenflurbil|
12073979|NCT00045123|Procedure|adjuvant therapy|
12073980|NCT00028678|Drug|dalteparin|
12073981|NCT00028678|Radiation|radiation therapy|
12073982|NCT00017342|Drug|bryostatin 1|
12073983|NCT00017342|Drug|cytarabine|
12073984|NCT00053742|Drug|Modified Vaccinia Virus Ankara TBC-MVA|
12073985|NCT00053703|Drug|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
12073986|NCT00053703|Drug|Olanzapine (enrollment closed in this treatment)|oral olanzapine 5-20mg per day for up to 52 weeks
12073987|NCT00053703|Drug|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
12073988|NCT00053690|Behavioral|Cognitive Behavior Treatment|
12073989|NCT00053677|Drug|Naltrexone|For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
12073990|NCT00053677|Drug|Placebo|For subjects who were randomly assigned to placebo.
12073991|NCT00053651|Behavioral|Survival Skills for Moms with New Babies|
12073992|NCT00053638|Drug|efavirenz|
12073993|NCT00053638|Drug|tenofovir|
12073994|NCT00053638|Drug|abacavir/lamivudine|
12073995|NCT00053625|Procedure|deep brain stimulation|Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
12073996|NCT00053612|Drug|Vitamin A|
12073997|NCT00053599|Drug|Simvastatin|
12073998|NCT00053573|Biological|Myozyme|20 mg/kg to 40 mg/kg qow
12073999|NCT00053560|Drug|Prasterone (GL701)|
12074000|NCT00053547|Drug|paricalcitol injection|
12074001|NCT00053508|Biological|ACAM1000|Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
12074002|NCT00053508|Biological|vaccinia virus (calf lymph) smallpox vaccine: Dryvax|group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)
12074003|NCT00053495|Biological|Vaccinia virus: ACAM2000 smallpox vaccine|Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
12074004|NCT00053495|Biological|vaccinia virus (calf lymph): Dryvax|Group 5 dose: 1.0x10-8th PFU/ml
12074005|NCT00053482|Biological|ACAM2000 Smallpox Vaccine|Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
12074006|NCT00053482|Biological|Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®|Group 5 dose: 1.0x10-8th PFU/ml
12074007|NCT00053443|Device|Medication Reminder System/Adherence Tracker|
12074008|NCT00053430|Drug|Thalidomide|Tablet taken orally daily
12074009|NCT00053430|Drug|Thalidomide placebo|Placebo tablet taken orally daily
12074010|NCT00053417|Drug|Placebo|Placebo for 15 weeks
12074011|NCT00053417|Drug|10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)|"2 week up titration (10 mg)
~12 weeks stable dose (10 mg)
~1 week down titration (10 mg)"
12074012|NCT00053417|Drug|15 mg fampridine-SR (4-aminopyridine, 4-AP)|"10 mg twice daily for 1 week
~15 mg twice daily for 14 weeks
~2 week up titration (10 mg x 1 week, 15 mg x 1 week)
~12 weeks stable dose (15 mg)
~1 week down titration (10 mg)"
12074013|NCT00053417|Drug|20 mg fampridine-SR (4-aminopyridine, 4-AP)|"2 week up titration (10 mg x 1 week, 15 mg x 1 week)
~12 weeks stable dose (20 mg)
~1 week down titration (15 mg x 3 days, 10 mg x 4 days)"
12074014|NCT00053391|Biological|recombinant CD40-ligand|
12074015|NCT00053391|Biological|therapeutic autologous dendritic cells|
12074016|NCT00053378|Drug|paricalcitol injection (Zemplar)|
12074017|NCT00053378|Behavioral|Effects on calcium regulation|
12074018|NCT00053378|Behavioral|Administration of elemental Ca during hypocalcemic ICU pts.|
12074019|NCT00053365|Drug|irofulven|Given IV
12074020|NCT00053352|Procedure|conventional surgery|
12074021|NCT00053352|Drug|cisplatin|Given IV
12074022|NCT00053352|Drug|etoposide|Given IV
12074023|NCT00053352|Biological|bleomycin sulfate|Given IV
12074024|NCT00053352|Other|laboratory biomarker analysis|Correlative studies
12074025|NCT00053339|Drug|tamoxifen|
12074026|NCT00053339|Drug|trastuzumab|
12074027|NCT00053326|Drug|fenretinide|Given orally
12074028|NCT00053326|Other|pharmacological study|Optional correlative studies
12074029|NCT00053300|Drug|thalidomide|oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
12074185|NCT00052429|Drug|fluorouracil|
12074186|NCT00052429|Procedure|adjuvant therapy|
12074030|NCT00053300|Procedure|adjuvant therapy|Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
12074031|NCT00053287|Drug|carboplatin|Carboplatin IV over 24 hours on days 1-5
12074032|NCT00053287|Drug|fludarabine phosphate|Fludarabine IV over 5-10 minutes on days 1-5.
12074033|NCT00053287|Drug|thalidomide|Oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity.
12074034|NCT00053287|Drug|topotecan hydrochloride|Topotecan IV continuously over 72 hours.
12074035|NCT00053261|Procedure|management of therapy complications|
12074036|NCT00053248|Drug|arsenic trioxide|
12074037|NCT00053248|Drug|imatinib mesylate|
12074038|NCT00053235|Genetic|Comparative Genomic Hybridization|Correlative studies
12074039|NCT00053235|Other|Laboratory Biomarker Analysis|Correlative studies
12074040|NCT00053235|Genetic|Polymerase Chain Reaction|Correlative studies
12074041|NCT00053222|Drug|arsenic trioxide|
12074042|NCT00053209|Drug|gemcitabine hydrochloride|
12074043|NCT00053209|Drug|pemetrexed disodium|
12074044|NCT00053196|Biological|anti-thymocyte globulin|2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)
12074045|NCT00053196|Biological|G-CSF|5 ug/kg/day subQ injection Day 7 until ANC> 1000/uL for 3 consec days
12074046|NCT00053196|Drug|busulfan|0.8mg/kg IV infusion over 2 hrs q 6 hrs x 8 doses Days -4 thru -3
12074047|NCT00053196|Drug|fludarabine phosphate|30 mg/sq m/day IVBP over 30 min Days -7 thru -3
12074048|NCT00053196|Drug|methotrexate|5 mg/sq m/day IV infusion Days 1, 3, & 6 for HLA-identical donor transplants and Days 1, 3, 6, & 11 for MUD & 9/10 related donor transplants
12074049|NCT00053196|Drug|mycophenolate mofetil|15mg/kg PO bid Day -2 to Day 60, then taper as tolerated (for MUD and 9/10 related donor transplants only)
12074050|NCT00053196|Drug|tacrolimus|target serum level is 5-10 ng/mL. Start with 0.03mg/kg PO bid Day -1 to Day 90, then taper thru Day 150 for HLA identical donor transplants and Day -1 to Day 180 then taper for MUD and 9/10 related donor transplants
12074051|NCT00053196|Procedure|allogeneic cell transplantation|2,000,000-8,000,000 CD34+ cells total via infusion Days 0 and 1
12074052|NCT00053196|Drug|allopurinol|300 mg/day PO Days -8 thru -1
12074053|NCT00053183|Procedure|conventional surgery|
12074054|NCT00053183|Radiation|brachytherapy|
12074055|NCT00053183|Radiation|radiation therapy|
12074056|NCT00053157|Biological|sargramostim|
12074057|NCT00053144|Drug|cytarabine|
12074058|NCT00053144|Drug|irinotecan hydrochloride|
12074059|NCT00053131|Biological|filgrastim|
12074060|NCT00053131|Biological|sargramostim|
12074061|NCT00053131|Drug|cytarabine|
12074062|NCT00053131|Drug|mitoxantrone hydrochloride|
12074063|NCT00053118|Biological|filgrastim|IV
12074064|NCT00053118|Drug|carboplatin|IV
12074065|NCT00053118|Drug|etoposide|IV
12074066|NCT00053118|Procedure|bone marrow ablation with stem cell support|IV
12074067|NCT00053118|Procedure|peripheral blood stem cell transplantation|IV
12074068|NCT00053105|Drug|cisplatin|
12074069|NCT00053105|Drug|cytarabine|
12074070|NCT00053105|Drug|methylprednisolone|
12074071|NCT00053105|Drug|pixantrone dimaleate|
12074072|NCT00053092|Biological|rituximab|
12074073|NCT00053092|Drug|cyclophosphamide|
12074074|NCT00053092|Drug|fludarabine phosphate|
12074075|NCT00053053|Dietary Supplement|Juven|
12074076|NCT00053053|Dietary Supplement|Non-Juven Supplement|
12074077|NCT00053040|Biological|cintredekin besudotox|IL13-PE38QQR is administered intracerebrally by continuous convection enhanced infusion at a starting concentration of 0.25 μg/mL. Infusion duration will be held constant at 96 hours (4 days). The phase I component of this study is to estimate the maximum safe total flow rate and the maximum safe infusion concentration.
12074078|NCT00053040|Procedure|conventional surgery|Conventional surgery is used for tumor resection prior to catheter placement for IL13-PE38QQR infusion.
12074079|NCT00053027|Biological|rituximab|
12074080|NCT00053027|Drug|cladribine|
12074081|NCT00053014|Biological|therapeutic allogeneic lymphocytes|
12074082|NCT00053014|Drug|cyclosporine|
12074083|NCT00053014|Drug|fludarabine|
12074084|NCT00053014|Drug|mycophenolate mofetil|
12074085|NCT00053014|Procedure|peripheral blood stem cell transplantation|
12074086|NCT00053014|Radiation|radiation therapy|
12074087|NCT00053001|Biological|epoetin alfa|
12074088|NCT00053001|Drug|thalidomide|
12074089|NCT00041275|Drug|megestrol acetate|
12074090|NCT00004078|Drug|irinotecan hydrochloride|Given IV
12074091|NCT00003830|Procedure|conventional surgery|Sentinel node resection immediately followed by axillary dissection.
12074092|NCT00003830|Procedure|Sentinel node resection followed by node examination|Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
12074093|NCT00052962|Procedure|Cytoreductive surgery|"Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.
~Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}."
12074187|NCT00052429|Radiation|radiation therapy|
12074188|NCT00052416|Drug|thalidomide|
12074189|NCT00052403|Drug|monoclonal antibody anti-anb3 integrin|
12074190|NCT00052403|Procedure|anti-cytokine therapy|
12074191|NCT00052403|Procedure|antiangiogenesis therapy|
12074192|NCT00052403|Procedure|antibody therapy|
12074193|NCT00052403|Procedure|biological response modifier therapy|
12074194|NCT00052403|Procedure|growth factor antagonist therapy|
12074195|NCT00052403|Procedure|monoclonal antibody therapy|
12074196|NCT00052390|Biological|bevacizumab|
12074094|NCT00052962|Procedure|Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)|"Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.
~Followed by continuous hyperthermic peritoneal perfusion (HIPEC) with 250 mg/m^2 cisplatin. Post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluororacil (5-FU) 800 mg/m^2 and paclitaxel 125 mg/m^2.
~Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}."
12074095|NCT00052949|Drug|imatinib mesylate|Given orally
12074096|NCT00052949|Other|laboratory biomarker analysis|Correlative studies
12074097|NCT00052936|Biological|filgrastim|
12074098|NCT00052936|Biological|rituximab|
12074099|NCT00052936|Drug|CHOP regimen|
12074100|NCT00052936|Drug|cyclophosphamide|
12074101|NCT00052936|Drug|doxorubicin hydrochloride|
12074102|NCT00052936|Drug|prednisone|
12074103|NCT00052936|Drug|vincristine sulfate|
12074104|NCT00052936|Radiation|radiation therapy|
12074105|NCT00052923|Biological|filgrastim|
12074106|NCT00052923|Biological|rituximab|
12074107|NCT00052923|Drug|carmustine|
12074108|NCT00052923|Drug|cyclophosphamide|
12074109|NCT00052923|Drug|etoposide|
12074110|NCT00052923|Procedure|peripheral blood stem cell transplantation|
12074111|NCT00052923|Radiation|radiation therapy|
12074112|NCT00052910|Drug|cisplatin|Given IV
12074113|NCT00052910|Drug|epirubicin hydrochloride|Given IV
12074114|NCT00052910|Drug|fluorouracil|Given IV
12074115|NCT00052910|Drug|leucovorin calcium|Given IV
12074116|NCT00052910|Radiation|radiation therapy|Given 5 days a week for 5 weeks
12074117|NCT00052897|Biological|HspE7|
12074118|NCT00052884|Biological|filgrastim|
12074119|NCT00052884|Drug|amifostine trihydrate|
12074120|NCT00052884|Drug|melphalan|
12074121|NCT00052884|Procedure|bone marrow ablation with stem cell support|
12074122|NCT00052884|Procedure|peripheral blood stem cell transplantation|
12074123|NCT00052845|Drug|docetaxel|70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle
12074124|NCT00052845|Drug|estramustine phosphate sodium|280 mg PO tid Days 1-5 of ea cycle
12074125|NCT00052845|Drug|exisulind|Two 125 mg capsules PO bid Days 1-21 of ea cycle
12074126|NCT00052832|Dietary Supplement|doxercalciferol|
12074127|NCT00052780|Drug|O6-benzylguanine|Given IV
12074128|NCT00052780|Drug|temozolomide|Given PO
12074129|NCT00052780|Biological|filgrastim|Given SC or IV
12074130|NCT00052780|Other|pharmacological study|Correlative studies
12074131|NCT00052780|Other|laboratory biomarker analysis|Correlative studies
12074132|NCT00052754|Drug|gefitinib|
12074133|NCT00052728|Drug|tamoxifen citrate|
12074134|NCT00052728|Drug|tipifarnib|
12074135|NCT00052715|Drug|poly ICLC|
12074136|NCT00052689|Drug|bortezomib|Given IV
12074137|NCT00052689|Drug|gemcitabine hydrochloride|Given IV
12074138|NCT00052676|Drug|patent blue V dye|
12074139|NCT00052676|Procedure|radionuclide imaging|
12074140|NCT00052676|Procedure|sentinel lymph node biopsy|
12074141|NCT00052676|Radiation|technetium Tc 99m sulfur colloid|
12074142|NCT00052637|Drug|hexaminolevulinate|
12074143|NCT00052637|Procedure|biopsy|
12074144|NCT00052637|Procedure|cystoscopy|
12074145|NCT00052624|Biological|transferrin-CRM107|
12074146|NCT00052611|Drug|Celecoxib|
12074147|NCT00052598|Biological|therapeutic allogeneic lymphocytes|Given IV
12074148|NCT00052598|Biological|aldesleukin|Given SC
12074149|NCT00052598|Other|laboratory biomarker analysis|Correlative studies
12074150|NCT00052598|Other|flow cytometry|Correlative studies
12074151|NCT00052585|Drug|irinotecan hydrochloride|Given IV
12074152|NCT00052585|Drug|gefitinib|Given orally
12074153|NCT00052585|Drug|leucovorin calcium|Given IV
12074154|NCT00052585|Drug|fluorouracil|Given IV
12074155|NCT00052572|Drug|ixabepilone|
12074156|NCT00052559|Biological|bevacizumab|Given IV
12074157|NCT00052559|Drug|fluorouracil|Given IV
12074158|NCT00052559|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
12074159|NCT00052559|Procedure|therapeutic conventional surgery|Undergo surgery
12074160|NCT00052559|Other|laboratory biomarker analysis|Correlative studies
12074161|NCT00052520|Biological|therapeutic allogeneic lymphocytes|Given IV
12074162|NCT00052520|Biological|aldesleukin|Given SC
12074163|NCT00052520|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
12074164|NCT00052520|Procedure|allogeneic bone marrow transplantation|Undergo transplantation
12074165|NCT00052520|Other|laboratory biomarker analysis|Correlative studies
12074166|NCT00052520|Genetic|gene expression analysis|Correlative studies
12074167|NCT00052520|Other|immunologic technique|Correlative studies
12074168|NCT00052520|Other|flow cytometry|Correlative studies
12074169|NCT00052520|Genetic|polymerase chain reaction|Correlative studies
12074170|NCT00052520|Genetic|cytogenetic analysis|Correlative studies
12074171|NCT00052520|Other|staining method|Correlative studies
12074172|NCT00052507|Drug|bortezomib|
12074173|NCT00052494|Drug|cisplatin|
12074174|NCT00052494|Drug|imatinib mesylate|
12074175|NCT00052494|Drug|irinotecan hydrochloride|
12074176|NCT00052481|Procedure|quality-of-life assessment|
12074177|NCT00052468|Drug|TCG|
12074178|NCT00052468|Drug|TC|
12074179|NCT00052455|Drug|lomustine|
12074180|NCT00052455|Drug|procarbazine hydrochloride|
12074181|NCT00052455|Drug|temozolomide|
12074182|NCT00052455|Drug|vincristine sulfate|
12074183|NCT00052442|Drug|pralatrexate|
12074184|NCT00052429|Drug|cisplatin|
12074197|NCT00052390|Drug|doxorubicin hydrochloride|
12074198|NCT00052377|Biological|aldesleukin|Given SC
12074199|NCT00052377|Biological|recombinant interleukin-12|Given SC
12074200|NCT00052377|Other|laboratory biomarker analysis|Correlative studies
12074201|NCT00052364|Drug|oxaliplatin|Given IV
12074202|NCT00052364|Other|laboratory biomarker analysis|Correlative studies
12074203|NCT00052351|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|
12074204|NCT00052351|Biological|recombinant vaccinia-CEA(6D)-TRICOM vaccine|
12074205|NCT00052351|Biological|sargramostim|
12074206|NCT00052351|Drug|cyclophosphamide|
12074207|NCT00052351|Drug|doxorubicin hydrochloride|
12074208|NCT00052351|Drug|paclitaxel|
12074209|NCT00052351|Radiation|radiation therapy|
12074210|NCT00052338|Drug|gemcitabine hydrochloride|Given IV
12074211|NCT00052338|Drug|carboplatin|Given IV
12074212|NCT00052338|Drug|bortezomib|Given IV
12074213|NCT00052338|Other|laboratory biomarker analysis|Correlative studies
12074214|NCT00052325|Dietary Supplement|mistletoe extract|
12074215|NCT00052312|Drug|cisplatin|
12074216|NCT00052312|Drug|doxorubicin hydrochloride|
12074217|NCT00052312|Drug|paclitaxel|
12074218|NCT00052299|Drug|cytarabine|
12074219|NCT00052299|Drug|etoposide|
12074220|NCT00052299|Drug|gemtuzumab ozogamicin|
12074221|NCT00052299|Drug|idarubicin|
12074222|NCT00052299|Drug|mitoxantrone hydrochloride|
12074223|NCT00052286|Drug|modafinil|
12074224|NCT00052273|Drug|capecitabine|
12074225|NCT00052273|Drug|enzastaurin hydrochloride|
12074226|NCT00052221|Biological|Epoetin alfa|
12074227|NCT00052221|Other|Placebo|
12074228|NCT00052208|Drug|gefitinib|Given PO
12074229|NCT00052208|Radiation|radiation therapy|Undergo radiation therapy
12074230|NCT00052208|Other|laboratory biomarker analysis|Correlative studies
12074231|NCT00052195|Biological|SRL-172|5 doses of 0.1mL vaccine or placebo given intradermally over 12-months
12074232|NCT00052182|Biological|EP HIV-1090|
12074233|NCT00052169|Drug|ZD1839 in combination with docetaxel|Docetaxel given as 75 mg/m2 IV every 3 weeks combined with ZD1839 (IRESSA) 250 mg orally daily until disease progression or withdrawal criteria are met.
12074234|NCT00049712|Biological|etaracizumab|
12074235|NCT00049699|Drug|laromustine|
12074236|NCT00049686|Drug|laromustine|
12074237|NCT00049673|Drug|prednisone|Given orally
12074238|NCT00049673|Drug|thalidomide|Given orally
12074239|NCT00049660|Drug|capecitabine|
12074240|NCT00049660|Drug|vinorelbine tartrate|
12074241|NCT00049634|Drug|busulfan|
12074242|NCT00049634|Drug|cyclophosphamide|
12074243|NCT00049634|Drug|cyclosporine|
12074244|NCT00049634|Drug|methotrexate|
12074245|NCT00049634|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12074246|NCT00049608|Dietary Supplement|mistletoe extract|
12074247|NCT00049608|Drug|gemcitabine hydrochloride|
12074248|NCT00049595|Biological|bleomycin sulfate|
12074249|NCT00049595|Biological|filgrastim|
12074250|NCT00049595|Biological|pegfilgrastim|
12074251|NCT00049595|Drug|ABVD regimen|
12074252|NCT00049595|Drug|BEACOPP regimen|
12074253|NCT00049595|Drug|cyclophosphamide|
12074254|NCT00049595|Drug|dacarbazine|
12074255|NCT00049595|Drug|doxorubicin hydrochloride|
12074256|NCT00049595|Drug|etoposide|
12074257|NCT00049595|Drug|prednisone|
12074258|NCT00049595|Drug|procarbazine hydrochloride|
12074259|NCT00049595|Drug|vinblastine sulfate|
12074260|NCT00049595|Drug|vincristine sulfate|
12074261|NCT00049582|Drug|decitabine|Given IV
12074262|NCT00049582|Other|laboratory biomarker analysis|Correlative studies
12074263|NCT00049582|Other|pharmacological study|Correlative studies
12074264|NCT00049569|Drug|cytarabine|Given IT
12074265|NCT00049569|Drug|methotrexate|Given IT
12074266|NCT00049569|Drug|vincristine sulfate|Given IV
12074267|NCT00049569|Drug|prednisone|Given PO
12074268|NCT00049569|Drug|pegaspargase|Given IM
12074269|NCT00049569|Drug|doxorubicin hydrochloride|Given IV
12074270|NCT00049569|Drug|imatinib mesylate|Given PO
12074271|NCT00049569|Drug|cyclophosphamide|Given IV
12074272|NCT00049569|Drug|etoposide|Given IV
12074273|NCT00049569|Biological|filgrastim|Given SC
12074274|NCT00049569|Drug|leucovorin calcium|Given IV
12074275|NCT00049569|Drug|asparaginase|Given IM
12074276|NCT00049569|Drug|therapeutic hydrocortisone|Given IT
12074277|NCT00049556|Drug|gefitinib|
12074278|NCT00049556|Other|immunohistochemistry staining method|
12074279|NCT00049556|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
12074280|NCT00049556|Procedure|biopsy|
12074281|NCT00049556|Procedure|sentinel lymph node biopsy|
12074282|NCT00049543|Drug|gefitinib|Given PO
12074283|NCT00049543|Other|placebo|Given PO
12074284|NCT00049543|Other|laboratory biomarker analysis|Correlative studies
12074285|NCT00049530|Biological|PEG-interferon alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
12074286|NCT00049517|Biological|sargramostim|Given IV or as an injection
12074287|NCT00049517|Drug|busulfan|Given IV
12074288|NCT00049517|Drug|cyclophosphamide|Given IV
12074289|NCT00049517|Drug|cytarabine|Given as a continuous infusion
12074290|NCT00049517|Drug|gemtuzumab ozogamicin (GO)|Given IV
12074291|NCT00049517|Drug|Daunorubicin|Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
12074367|NCT00049140|Drug|EF5|
12074292|NCT00049517|Procedure|Autologous HCT|Autologous hematopoietic cell transplantation
12074293|NCT00049517|Procedure|Allogeneic HCT|Allogeneic hematopoietic cell transplantation
12074294|NCT00049504|Drug|cyclophosphamide|Given IV
12074295|NCT00049504|Drug|fludarabine phosphate|Given IV
12074296|NCT00049504|Drug|tacrolimus|Given IV or orally
12074297|NCT00049504|Drug|mycophenolate mofetil|Given orally
12074298|NCT00049504|Genetic|polymerase chain reaction|Correlative studies
12074299|NCT00049504|Genetic|fluorescence in situ hybridization|Correlative studies
12074300|NCT00049504|Genetic|polymorphism analysis|Correlative studies
12074301|NCT00049504|Genetic|gene expression analysis|Correlative studies
12074302|NCT00049504|Radiation|total-body irradiation|Undergo total-body irradiation
12074303|NCT00049504|Procedure|allogeneic bone marrow transplantation|Undergo haploidentical hematopoietic bone marrow transplantation
12074304|NCT00049504|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo haploidentical hematopoietic bone marrow transplantation
12074305|NCT00049465|Procedure|fatigue assessment and management|
12074306|NCT00049465|Procedure|management of therapy complications|
12074307|NCT00049465|Procedure|psychosocial assessment and care|
12074308|NCT00049452|Drug|zoledronic acid|
12074309|NCT00049439|Biological|filgrastim|filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
12074310|NCT00049439|Drug|cyclophosphamide|Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
12074311|NCT00049439|Drug|etoposide|Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
12074312|NCT00049439|Drug|lomustine|Oral lomustine on day 1 (course 1 only). Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
12074313|NCT00049439|Drug|procarbazine hydrochloride|Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
12074314|NCT00049413|Biological|rituximab|
12074315|NCT00049413|Drug|cyclophosphamide|
12074316|NCT00049413|Drug|pentostatin|
12074317|NCT00049400|Drug|BMS-247550|BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
12074318|NCT00049387|Drug|tipifarnib|Given PO
12074319|NCT00049387|Drug|temozolomide|Given PO
12074320|NCT00049387|Radiation|radiation therapy|Undergo partial brain radiation therapy
12074321|NCT00049374|Biological|oblimersen sodium|
12074322|NCT00049374|Drug|dexamethasone|
12074323|NCT00049374|Drug|thalidomide|
12074324|NCT00049361|Drug|temozolomide|
12074325|NCT00049361|Drug|thalidomide|
12074326|NCT00049361|Radiation|radiation therapy|
12074327|NCT00049348|Biological|epoetin alfa|
12074328|NCT00049348|Biological|filgrastim|
12074329|NCT00049348|Drug|cisplatin|
12074330|NCT00049348|Drug|fluorouracil|
12074331|NCT00049348|Drug|gemcitabine hydrochloride|
12074332|NCT00049348|Procedure|adjuvant therapy|
12074333|NCT00049348|Procedure|conventional surgery|
12074334|NCT00049348|Procedure|neoadjuvant therapy|
12074335|NCT00049348|Radiation|radiation therapy|
12074336|NCT00049335|Drug|capecitabine|1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, on Days 1-14 of 21 day cycle
12074337|NCT00049322|Biological|bevacizumab|"Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
12074338|NCT00049309|Dietary Supplement|dietary intervention|
12074339|NCT00049309|Dietary Supplement|flaxseed|
12074340|NCT00049296|Drug|docetaxel|"Patients receive docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
~Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined."
12074341|NCT00049296|Drug|thalidomide|"Patients receive oral thalidomide twice daily. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
~Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined."
12074342|NCT00049283|Drug|erlotinib hydrochloride|Given orally
12074343|NCT00049283|Drug|docetaxel|Given IV
12074344|NCT00049283|Radiation|radiation therapy|Undergo radiotherapy
12074345|NCT00049283|Procedure|therapeutic conventional surgery|Undergo neck dissection
12074346|NCT00049283|Other|laboratory biomarker analysis|Correlative studies
12074347|NCT00049283|Other|pharmacological study|Correlative studies
12074348|NCT00049257|Drug|carboplatin|Administered Day 1 of each cycle. AUC=6.
12074349|NCT00049257|Drug|paclitaxel|administered Days 1, 8, and 15 of each cycle. 100mg/m2
12074350|NCT00049244|Drug|capecitabine|
12074351|NCT00049244|Drug|ixabepilone|
12074352|NCT00049231|Drug|EF5|
12074353|NCT00049231|Other|immunohistochemistry staining method|
12074354|NCT00049231|Procedure|biopsy|
12074355|NCT00049218|Biological|Autologous dendritic cell-adenovirus p53 vaccine|
12074356|NCT00049218|Drug|Carboplatin|
12074357|NCT00049218|Drug|Etoposide|
12074358|NCT00049192|Biological|oblimersen sodium|Given IV
12074359|NCT00049192|Drug|imatinib mesylate|Given PO
12074360|NCT00049192|Other|laboratory biomarker analysis|Correlative studies
12074361|NCT00049179|Drug|cytarabine|ind and consol: 200 mg/m2/d continuous IV days 1-7
12074362|NCT00049179|Drug|gemtuzumab ozogamicin|ind and consol: 6 mg/m2 IV over 2 hrs day 1, 4mg/m2 IV over 2 hrs day 8
12074363|NCT00049166|Drug|erlotinib hydrochloride|Given orally
12074364|NCT00049166|Drug|cisplatin|Given IV
12074365|NCT00049166|Radiation|intensity-modulated radiation therapy|Undergo intensity modulated radiation therapy
12074366|NCT00049166|Other|laboratory biomarker analysis|Correlative studies
12074370|NCT00049140|Other|immunohistochemistry staining method|
12074371|NCT00049140|Procedure|biopsy|
12074372|NCT00049127|Drug|Imatinib Mesylate|Given PO
12074373|NCT00049127|Other|Laboratory Biomarker Analysis|Optional correlative studies
12074374|NCT00049127|Other|Pharmacological Study|Optional correlative studies
12074375|NCT00049114|Drug|doxorubicin hydrochloride|
12074376|NCT00049114|Drug|cyclophosphamide|Given IV
12074377|NCT00049114|Drug|tipifarnib|Given orally
12074378|NCT00049114|Biological|filgrastim|Given subcutaneously
12074379|NCT00049114|Procedure|therapeutic conventional surgery|Undergo complete resection
12074380|NCT00049114|Other|laboratory biomarker analysis|Correlative studies
12074381|NCT00049101|Drug|erlotinib hydrochloride|
12074382|NCT00049101|Drug|fluorouracil|
12074383|NCT00049101|Drug|leucovorin calcium|
12074384|NCT00049101|Drug|oxaliplatin|
12074385|NCT00049088|Drug|docetaxel|Given IV
12074386|NCT00049088|Biological|bevacizumab|Given IV
12074387|NCT00049088|Other|laboratory biomarker analysis|Correlative studies
12074388|NCT00049088|Other|pharmacological study|Correlative studies
12074389|NCT00049075|Drug|fludarabine phosphate|
12074390|NCT00049062|Drug|anastrozole|
12074391|NCT00049062|Drug|gefitinib|
12074392|NCT00049036|Biological|rituximab|Given IV
12074393|NCT00049036|Drug|etoposide|Given IV
12074394|NCT00049036|Drug|doxorubicin hydrochloride|Given IV
12074395|NCT00049036|Drug|vincristine sulfate|Given IV
12074396|NCT00049036|Drug|prednisone|Given orally
12074397|NCT00049036|Drug|cyclophosphamide|Given IV
12074398|NCT00049036|Other|laboratory biomarker analysis|Correlative studies
12074399|NCT00049023|Radiation|90Y-DOTA-tyr3-OCTREOTIDE|
12074400|NCT00049010|Genetic|comparative genomic hybridization|
12074401|NCT00049010|Genetic|cytogenetic analysis|
12074402|NCT00049010|Genetic|fluorescence in situ hybridization|
12074403|NCT00049010|Other|immunohistochemistry staining method|
12074404|NCT00048997|Radiation|Radiation therapy|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
12074405|NCT00048997|Other|Observation|
12074406|NCT00048984|Other|laboratory biomarker analysis|Correlative studies
12074407|NCT00048971|Genetic|mutation analysis|
12074408|NCT00048971|Genetic|polymorphic microsatellite marker analysis|
12074409|NCT00048958|Genetic|cytogenetic analysis|
12074410|NCT00047385|Device|low-dose helical computed tomography|A LDCT is a computerized tomography image with low-dose technique without contrast. The scan is done from the neck to the diaphragm in one breath-hold.
12074411|NCT00047385|Device|chest radiography|The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
12074412|NCT00047346|Drug|erlotinib hydrochloride|Given PO
12074413|NCT00047346|Other|pharmacological study|Correlative studies
12074414|NCT00047346|Other|laboratory biomarker analysis|Correlative studies
12074415|NCT00047333|Drug|erlotinib hydrochloride|Given PO
12074416|NCT00047333|Other|laboratory biomarker analysis|Correlative studies
12074417|NCT00047333|Other|pharmacological study|Correlative studies
12074418|NCT00047320|Drug|carboplatin|Given IV
12074419|NCT00047320|Drug|etoposide|Given IV
12074420|NCT00047320|Drug|ifosfamide|Given IV
12074421|NCT00047320|Drug|thiotepa|Given IV
12074422|NCT00047320|Procedure|adjuvant therapy|
12074423|NCT00047320|Procedure|conventional surgery|
12074424|NCT00047320|Procedure|neoadjuvant therapy|
12074425|NCT00047320|Procedure|peripheral blood stem cell transplantation|
12074426|NCT00047320|Radiation|radiation therapy|craniospinal irradiation
12074427|NCT00047307|Drug|alvocidib|Given IV
12074428|NCT00047307|Drug|gemcitabine hydrochloride|Given IV
12074429|NCT00047307|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal radiation therapy
12074430|NCT00047307|Other|laboratory biomarker analysis|Correlative studies
12074431|NCT00047294|Drug|celecoxib|
12074432|NCT00047294|Drug|temozolomide|
12074433|NCT00047294|Drug|thalidomide|
12074434|NCT00047294|Procedure|adjuvant therapy|
12074435|NCT00047281|Drug|celecoxib|
12074436|NCT00047281|Drug|cyclophosphamide|
12074437|NCT00047281|Drug|etoposide|
12074438|NCT00047281|Drug|thalidomide|
12074439|NCT00047268|Drug|cytarabine|
12074440|NCT00047268|Drug|mercaptopurine|
12074441|NCT00047268|Other|laboratory biomarker analysis|
12074442|NCT00047268|Procedure|allogeneic bone marrow transplantation|
12074443|NCT00047268|Procedure|biopsy|
12074444|NCT00047268|Procedure|peripheral blood stem cell transplantation|
12074445|NCT00047255|Biological|trastuzumab|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose admin by IV over 90 mins, Day 2: Docetaxel (T) 75 mg/m2 by IV over 1 hour followed by carboplatin (C) at target AUC=6 mg/mL/min admin by IV over 30-60 mins, Day 8: (H) 2mg/kg admin by IV over 30 mins, Day 15: 2mg/kg admin by IV over 30 mins.
~Subsequent cycles: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins.
~Last cycle: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins, Day 22: (H) 6 mg/kg admin by IV over 30 mins."
12074498|NCT00047021|Biological|sargramostim|Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
12074499|NCT00047021|Drug|cytarabine|high-dose cytarabine IV over 1 hour on days 1-5
12074500|NCT00047021|Drug|mitoxantrone hydrochloride|high-dose mitoxantrone IV over 15-30 minutes on day 5.
12074501|NCT00047008|Drug|cisplatin|100 mg/m^2 intravenously on days 1, 22
12074563|NCT00045617|Biological|monoclonal antibody 11D10 anti-idiotype vaccine|
12074446|NCT00047255|Drug|carboplatin|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose admin by IV over 90 mins, Day 2: Docetaxel (T) 75 mg/m2 by IV over 1 hour followed by carboplatin (C) at target AUC=6 mg/mL/min admin by IV over 30-60 mins, Day 8: (H) 2mg/kg admin by IV over 30 mins, Day 15: 2mg/kg admin by IV over 30 mins.
~Subsequent cycles: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins.
~Last cycle: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins, Day 22: (H) 6 mg/kg admin by IV over 30 mins."
12074447|NCT00047255|Drug|docetaxel|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose administered by IV infusion over 90 minutes, Day 2: Docetaxel (T) 100 mg/m2 by IV infusion over 30 minutes, Day 8: (H) 2mg/kg administered by IV infusion over 30 minutes, Day 15: 2mg/kg administered by IV infusion over 30 minutes.
~Subsequent cycles: Day 1: (T) 100mg/m2 as 1 hour IV infusion given every 3 weeks, followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes.
~Last cycle: Day 1: (T) 100mg/m2 as 1 hour IV infusion followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 22: (H) 6 mg/kg administered by IV infusion over 30 minutes."
12074448|NCT00047255|Biological|trastuxumab|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose administered by IV infusion over 90 minutes, Day 2: Docetaxel (T) 100 mg/m2 by IV infusion over 30 minutes, Day 8: (H) 2mg/kg administered by IV infusion over 30 minutes, Day 15: 2mg/kg administered by IV infusion over 30 minutes.
~Subsequent cycles: Day 1: (T) 100mg/m2 as 1 hour IV infusion given every 3 weeks, followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes.
~Last cycle: Day 1: (T) 100mg/m2 as 1 hour IV infusion followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 22: (H) 6 mg/kg administered by IV infusion over 30 minutes."
12074449|NCT00047255|Drug|Docetaxel|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose admin by IV over 90 mins, Day 2: Docetaxel (T) 75 mg/m2 by IV over 1 hour followed by carboplatin (C) at target AUC=6 mg/mL/min admin by IV over 30-60 mins, Day 8: (H) 2mg/kg admin by IV over 30 mins, Day 15: 2mg/kg admin by IV over 30 mins.
~Subsequent cycles: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins.
~Last cycle: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins, Day 22: (H) 6 mg/kg admin by IV over 30 mins."
12074450|NCT00047242|Drug|7-hydroxystaurosporine|
12074451|NCT00047242|Drug|irinotecan hydrochloride|
12074452|NCT00047229|Biological|oblimersen sodium|
12074453|NCT00047229|Drug|doxorubicin hydrochloride|
12074454|NCT00047216|Drug|tipifarnib|
12074455|NCT00047203|Drug|alvocidib|Given IV
12074456|NCT00047190|Drug|tipifarnib|Given PO
12074457|NCT00047190|Other|laboratory biomarker analysis|Correlative studies
12074458|NCT00047177|Drug|Oxaliplatin|
12074459|NCT00047164|Biological|ipilimumab|
12074460|NCT00047138|Biological|dactinomycin|
12074461|NCT00047138|Drug|carboplatin|
12074462|NCT00047138|Drug|cyclophosphamide|
12074463|NCT00047138|Drug|doxorubicin hydrochloride|
12074464|NCT00047138|Drug|etoposide|
12074465|NCT00047138|Drug|vincristine sulfate|
12074466|NCT00047138|Procedure|adjuvant therapy|
12074467|NCT00047138|Procedure|conventional surgery|
12074468|NCT00047138|Procedure|neoadjuvant therapy|
12074469|NCT00047138|Radiation|radiation therapy|
12074470|NCT00047125|Radiation|radiation therapy|
12074471|NCT00047112|Drug|cisplatin|
12074472|NCT00047112|Drug|fluorouracil|
12074473|NCT00047112|Procedure|conventional surgery|
12074474|NCT00047112|Procedure|neoadjuvant therapy|
12074475|NCT00047112|Radiation|radiation therapy|
12074476|NCT00047099|Drug|cyclophosphamide|
12074477|NCT00047099|Drug|docetaxel|
12074478|NCT00047099|Drug|epirubicin hydrochloride|
12074479|NCT00047099|Drug|fluorouracil|
12074480|NCT00047099|Drug|goserelin acetate|
12074481|NCT00047099|Drug|tamoxifen citrate|
12074482|NCT00047099|Procedure|adjuvant therapy|
12074483|NCT00047099|Radiation|radiation therapy|
12074484|NCT00047073|Drug|Rapamycin|"Phase 1: Initial dose 6mg on day 1 and then 2mg each day for 5-7 days before surgery. No dosing during surgery recovery. After recorvery 6mg loading dose on day 1 then 2mg each day. Cycle is every 4 weeks.
~Dose escalation: Level 2: 15mg load/5mg/day, Level 3: 30mg load/10mg/day, Level 4: 45mg load/15mg/day.
~Phase 2: Will utilize dose established in phase I. Dosing schedule will remain the same."
12074485|NCT00047073|Procedure|Surgery|Surgical resection.
12074486|NCT00047073|Procedure|Supportive Care|"Corticosteroids should be used in smallest dose to control symptoms of cerebral edema and mass effect.
~Anti-seizure medications should be used as indicated. Febrile neutropenia may be managed according to local institution's infectious disease guidelines.
~If neurosurgical management is required for reasons not due to tumor progression, these procedures must be documented."
12074487|NCT00047060|Other|A matched peripheral donor stem cells|A matched peripheral donor stem cells
12074488|NCT00047060|Drug|cyclosporine|cyclosporine
12074489|NCT00047060|Drug|fludarabine|fludarabine
12074490|NCT00047060|Drug|Campath|Campath
12074491|NCT00047047|Drug|gemcitabine hydrochloride|Given IV
12074492|NCT00047047|Drug|tanespimycin|Given IV
12074493|NCT00047047|Drug|cisplatin|Given IV
12074494|NCT00047047|Other|laboratory biomarker analysis|Correlative studies
12074495|NCT00047034|Drug|eribulin mesylate|Given IV
12074496|NCT00047034|Other|pharmacological study|Correlative studies
12074497|NCT00047034|Other|laboratory biomarker analysis|Correlative studies
12074502|NCT00047008|Radiation|Standard fractionation RT|Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy.
12074503|NCT00047008|Radiation|Accelerated fractionation radiation therapy|Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks.
12074504|NCT00047008|Procedure|Conventional surgery for select patients|"Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer.
~A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made."
12074505|NCT00046995|Drug|carboplatin|
12074506|NCT00046995|Drug|fluorouracil|
12074507|NCT00046995|Drug|leucovorin calcium|
12074508|NCT00046995|Procedure|adjuvant therapy|
12074509|NCT00046969|Biological|epoetin beta|
12074510|NCT00046969|Drug|cisplatin|
12074511|NCT00046969|Radiation|brachytherapy|
12074512|NCT00046969|Radiation|radiation therapy|
12074513|NCT00046943|Drug|atrasentan hydrochloride|
12074514|NCT00046930|Biological|filgrastim|250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to > 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
12074515|NCT00046930|Biological|sargramostim|5 μg/kg/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to > 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
12074516|NCT00046930|Drug|cytarabine|100 mg/m²/day by continuous intravenous infusion for 7 days (days 1-7).
12074517|NCT00046930|Drug|daunorubicin hydrochloride|45 mg/m²/day by 10 - 15 minute intravenous infusion for 3 days (days 1, 2, and 3).
12074518|NCT00046930|Drug|zosuquidar trihydrochloride|"Zosuquidar 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3.
~The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3."
12074519|NCT00046930|Drug|Placebo|"Placebo 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3.
~The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. Placebo consisted of a 1:1000 dilution of Infuvite, appropriately colored."
12074520|NCT00046917|Drug|alvocidib|Given IV
12074521|NCT00046917|Drug|irinotecan hydrochloride|Given IV
12074522|NCT00046917|Drug|cisplatin|Given IV
12074523|NCT00046904|Biological|etanercept|
12074524|NCT00046891|Drug|Ginkgo Biloba|Patients will take 120 mg per day (60 mg BID)
12074525|NCT00046891|Other|Placebo|Patients will take 1 tablet BID
12074526|NCT00046865|Procedure|acupressure therapy|
12074527|NCT00046865|Procedure|management of therapy complications|
12074528|NCT00046865|Procedure|nausea and vomiting therapy|
12074529|NCT00046852|Biological|filgrastim|
12074530|NCT00046852|Biological|pneumococcal polyvalent vaccine|
12074531|NCT00046852|Biological|therapeutic autologous lymphocytes|
12074532|NCT00046852|Biological|therapeutic tumor infiltrating lymphocytes|
12074533|NCT00046852|Drug|carmustine|
12074534|NCT00046852|Drug|cyclophosphamide|
12074535|NCT00046852|Drug|melphalan|
12074536|NCT00046852|Procedure|bone marrow ablation with stem cell support|
12074537|NCT00046852|Procedure|peripheral blood stem cell transplantation|
12074538|NCT00046839|Drug|celecoxib|
12074539|NCT00046839|Radiation|radiation therapy|
12074540|NCT00046826|Drug|docetaxel|
12074541|NCT00046826|Drug|estramustine phosphate sodium|
12074542|NCT00046826|Drug|thalidomide|
12074543|NCT00045747|Drug|7-hydroxystaurosporine|
12074544|NCT00045747|Drug|fluorouracil|
12074545|NCT00045734|Drug|imatinib mesylate|Given orally
12074546|NCT00045734|Other|laboratory biomarker analysis|Correlative studies
12074547|NCT00045734|Other|pharmacological study|Correlative studies
12074548|NCT00045721|Drug|O6-benzylguanine|
12074549|NCT00045721|Drug|polifeprosan 20 with carmustine implant|
12074550|NCT00045721|Procedure|adjuvant therapy|
12074551|NCT00045721|Procedure|conventional surgery|
12074552|NCT00045721|Procedure|neoadjuvant therapy|
12074553|NCT00045708|Drug|ixabepilone|Given IV
12074554|NCT00045708|Other|pharmacological study|Correlative studies
12074555|NCT00045708|Drug|Anticonvulsant|Drugs that induce hepatic Metabolic enzymes
12074556|NCT00045695|Drug|bortezomib|PS-341 bolus intravenous injection twice weekly* for 2 out of every 3 weeks
12074557|NCT00045682|Drug|Paclitaxel Poliglumex|Given IV
12074558|NCT00045669|Drug|imatinib mesylate|
12074559|NCT00045630|Drug|carboplatin|
12074560|NCT00045630|Drug|gemcitabine|
12074561|NCT00045630|Drug|paclitaxel|
12074562|NCT00045630|Procedure|surgery|
12074564|NCT00045617|Biological|monoclonal antibody GD2 anti-idiotype vaccine|
12074565|NCT00045617|Drug|cisplatin|
12074566|NCT00045617|Drug|etoposide|
12074567|NCT00045617|Radiation|radiation therapy|
12074568|NCT00045604|Drug|cisplatin|
12074569|NCT00045604|Drug|imatinib mesylate|
12074570|NCT00045604|Drug|irinotecan hydrochloride|
12074571|NCT00045591|Drug|celecoxib|100 mg PO bid
12074572|NCT00045591|Drug|Celecoxib|400 mg PO bid
12074573|NCT00045565|Drug|arsenic trioxide|Given IV
12074574|NCT00045565|Radiation|radiation therapy|Undergo radiation therapy
12074575|NCT00045539|Drug|leucovorin calcium|
12074576|NCT00045539|Drug|methotrexate|
12074577|NCT00045539|Drug|thiotepa|
12074578|NCT00045526|Drug|erlotinib hydrochloride|Given PO
12074579|NCT00045526|Other|laboratory biomarker analysis|Correlative studies
12074580|NCT00045513|Drug|7-hydroxystaurosporine|
12074581|NCT00045513|Drug|fludarabine phosphate|
12074582|NCT00045500|Drug|7-hydroxystaurosporine|
12074583|NCT00045500|Drug|prednisone|
12074584|NCT00045487|Drug|OSI-774|OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.
12074585|NCT00045474|Procedure|adjuvant therapy|
12074586|NCT00045474|Radiation|iodine I 125|
12074587|NCT00045461|Drug|carboplatin|
12074588|NCT00045461|Drug|ifosfamide|
12074589|NCT00045461|Procedure|hyperthermia treatment|
12074590|NCT00045448|Drug|alvocidib|
12074591|NCT00045448|Drug|docetaxel|
12074592|NCT00045435|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplant
12074593|NCT00045435|Drug|fludarabine phosphate|Given IV
12074594|NCT00045435|Radiation|total-body irradiation|Undergo TBI
12074595|NCT00045435|Drug|cyclosporine|Given PO
12074596|NCT00045435|Drug|mycophenolate mofetil|Given PO
12074597|NCT00045435|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplant
12074598|NCT00045422|Biological|recombinant interferon alfa|
12074599|NCT00045422|Drug|imatinib mesylate|
12074600|NCT00045396|Drug|tipifarnib|Given orally
12074601|NCT00045370|Biological|recombinant interferon alfa|
12074602|NCT00045370|Drug|temsirolimus|
12074603|NCT00045331|Genetic|proteomic profiling|
12074604|NCT00045318|Drug|exatecan mesylate|
12074605|NCT00045305|Drug|Cyclosporine|Immunosuppressant
12074606|NCT00045305|Drug|Methotrexate|Antimetabolite
12074607|NCT00045305|Drug|Photopheresis|Psoralens
12074608|NCT00045305|Drug|Mycofenolate mofetil|an antibiotic with immunosuppressamt properties isolated from Penicillium spp
12074609|NCT00045305|Drug|Pentostatin|Purine analogue
12074610|NCT00045305|Procedure|allogeneic bone marrow|Unmanipulated allogeneic bone marrow
12074611|NCT00045305|Procedure|peripheral blood stem cell|G-CSF mobilized peripheral blood stem cell
12074612|NCT00045305|Radiation|Total body irradiation|a total of 600 cGy given in 3 200 cGy fractionated doses
12074613|NCT00045292|Drug|acyclovir|
12074614|NCT00045292|Drug|acyclovir sodium|
12074615|NCT00045292|Drug|valacyclovir|
12074616|NCT00045279|Biological|PEG-interferon alfa-2b|
12074617|NCT00045266|Biological|ziv-aflibercept|
12074618|NCT00045227|Biological|recombinant fowlpox-prostate specific antigen vaccine|
12074619|NCT00045227|Biological|recombinant vaccinia prostate-specific antigen vaccine|
12074620|NCT00045227|Biological|recombinant vaccinia-B7.1 vaccine|
12074621|NCT00045227|Biological|sargramostim|
12074622|NCT00045227|Drug|docetaxel|
12074623|NCT00045201|Drug|Erlotinib Hydrochloride|Given orally
12074624|NCT00045201|Drug|Irinotecan Hydrochloride|Given IV
12074625|NCT00045188|Drug|imatinib mesylate|Given PO
12074626|NCT00045188|Other|laboratory biomarker analysis|Optional correlative studies
12074627|NCT00045175|Drug|7-hydroxystaurosporine|
12074628|NCT00045175|Drug|topotecan hydrochloride|
12074629|NCT00045162|Drug|cisplatin|"Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles
~Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles"
12074630|NCT00045162|Drug|etoposide|100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles
12074631|NCT00045162|Drug|irinotecan hydrochloride|60 mg/m2 IV (over 90 min)on Days 1, 8 & 15. Q 4 weeks x 4 Cycles
12074632|NCT00045136|Drug|melphalan|
12074633|NCT00045136|Procedure|peripheral blood stem cell transplantation|
12074634|NCT00045136|Radiation|holmium Ho 166 DOTMP|
12074635|NCT00045110|Drug|erlotinib hydrochloride|given orally
12074636|NCT00045110|Other|laboratory biomarker analysis|correlative studies
12074637|NCT00045110|Other|pharmacological study|correlative studies
12074638|NCT00045097|Drug|ixabepilone|
12074639|NCT00045045|Procedure|positron emission tomography|
12074640|NCT00045045|Radiation|fludeoxyglucose F 18|
12074641|NCT00045032|Drug|Herceptin|Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
12074642|NCT00045032|Drug|Herceptin|Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
12074643|NCT00045019|Other|quality-of-life assessment|QLQ-C30 SAT32
12074644|NCT00045006|Drug|vorinostat|
12074645|NCT00044993|Biological|Ad5CMV-p53 gene|
12074646|NCT00044993|Drug|docetaxel|
12074647|NCT00044993|Drug|doxorubicin hydrochloride|
12074648|NCT00044993|Procedure|conventional surgery|
12074649|NCT00044993|Procedure|neoadjuvant therapy|
12074650|NCT00044980|Procedure|nutritional support|
12074651|NCT00044980|Procedure|quality-of-life assessment|
12074652|NCT00044967|Genetic|microsatellite instability analysis|
12074653|NCT00044954|Biological|therapeutic allogeneic lymphocytes|
12074655|NCT00044954|Drug|fludarabine phosphate|
12074656|NCT00044954|Drug|mycophenolate mofetil|
12074657|NCT00044954|Procedure|allogeneic bone marrow transplantation|
12074658|NCT00044954|Procedure|peripheral blood stem cell transplantation|
12074659|NCT00044954|Radiation|radiation therapy|
12074660|NCT00043147|Drug|beclomethasone dipropionate|
12074661|NCT00043147|Drug|methylprednisolone|
12074662|NCT00043147|Drug|prednisone|
12074663|NCT00043134|Drug|decitabine|
12074664|NCT00043121|Drug|oxaliplatin|Given IV
12074665|NCT00043121|Drug|leucovorin calcium|Given IV
12074666|NCT00043121|Drug|fluorouracil|Given IV
12074667|NCT00043121|Drug|capecitabine|Given orally
12074668|NCT00043121|Other|pharmacological study|Correlative studies
12074669|NCT00043095|Drug|gemcitabine hydrochloride|
12074670|NCT00043095|Drug|ixabepilone|
12074671|NCT00043082|Drug|carboplatin|intravenous q 4 weeks
12074672|NCT00043082|Drug|pegylated liposomal doxorubicin hydrochloride|intravenous q 4 weeks
12074673|NCT00043069|Dietary Supplement|calcium carbonate|
12074674|NCT00043069|Dietary Supplement|cholecalciferol|
12074675|NCT00043069|Drug|Estrogen Antagonists|
12074676|NCT00043069|Drug|risedronate sodium|
12074677|NCT00043069|Other|placebo|
12074678|NCT00043043|Drug|celecoxib|
12074679|NCT00043030|Procedure|psychosocial assessment and care|
12074680|NCT00043017|Procedure|MRI/MRS|Serial MRI studies evaluated for prognostic properties related to therapeutic response.
12074681|NCT00043017|Radiation|gadopentetate dimeglumine|Imaging agent used for contrast enhancement in each of the MRIs.
12074682|NCT00043004|Biological|bevacizumab|
12074683|NCT00043004|Drug|FOLFOX regimen|
12074684|NCT00043004|Drug|fluorouracil|
12074685|NCT00043004|Drug|leucovorin calcium|
12074686|NCT00043004|Drug|oxaliplatin|
12074687|NCT00043004|Procedure|conventional surgery|
12074688|NCT00043004|Procedure|radiofrequency ablation|
12074689|NCT00042991|Drug|gefitinib|Given orally
12074690|NCT00042991|Radiation|radiation therapy|Undergo standard brain irradiation
12074691|NCT00042991|Other|pharmacological study|Correlative studies
12074692|NCT00042991|Other|laboratory biomarker analysis|Correlative studies
12074693|NCT00042978|Biological|oblimersen sodium|Given IV
12074694|NCT00042978|Drug|carboplatin|Given IV
12074695|NCT00042978|Drug|etoposide|Given IV
12074696|NCT00042965|Drug|capecitabine|
12074697|NCT00042965|Drug|gemcitabine hydrochloride|
12074698|NCT00042952|Drug|imatinib mesylate|Given orally
12074699|NCT00042952|Procedure|therapeutic conventional surgery|Undergo surgical resection
12074700|NCT00042952|Other|laboratory biomarker analysis|Correlative studies
12074701|NCT00042939|Biological|cetuximab|Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks.
12074702|NCT00042939|Drug|docetaxel|Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution.
12074703|NCT00042939|Drug|irinotecan hydrochloride|After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest.
12074704|NCT00042926|Other|immunohistochemistry staining method|
12074705|NCT00042926|Procedure|conventional surgery|
12074706|NCT00042926|Procedure|lymphangiography|
12074707|NCT00042926|Procedure|radionuclide imaging|
12074708|NCT00042926|Procedure|sentinel lymph node biopsy|
12074709|NCT00042926|Radiation|technetium Tc 99m sulfur colloid|
12074710|NCT00042913|Biological|epratuzumab|
12074711|NCT00042887|Drug|mitomycin C|
12074712|NCT00042887|Procedure|conventional surgery|
12074713|NCT00042874|Drug|alvocidib|Given IV
12074714|NCT00042874|Drug|irinotecan hydrochloride|Given IV
12074715|NCT00042874|Drug|fluorouracil|Given IV
12074716|NCT00042874|Drug|leucovorin calcium|Given IV
12074717|NCT00042874|Other|laboratory biomarker analysis|Correlative studies
12074718|NCT00042861|Drug|7-hydroxystaurosporine|
12074719|NCT00042861|Drug|fluorouracil|
12074720|NCT00042861|Drug|leucovorin calcium|
12074721|NCT00042848|Drug|modafinil|
12074722|NCT00042835|Drug|cisplatin|Given IV
12074723|NCT00042835|Drug|etoposide|Given IV
12074724|NCT00042835|Drug|erlotinib hydrochloride|Given orally
12074725|NCT00042835|Radiation|radiation therapy|Undergo radiotherapy
12074726|NCT00042835|Drug|docetaxel|Given IV
12074727|NCT00042835|Drug|paclitaxel|Given IV
12074728|NCT00042835|Drug|carboplatin|Given IV
12074729|NCT00042835|Other|laboratory biomarker analysis|Correlative studies
12074730|NCT00042822|Drug|romidepsin|
12074731|NCT00042809|Drug|paclitaxel|Given IV
12074732|NCT00042809|Biological|trastuzumab|Given IV
12074733|NCT00042809|Drug|erlotinib hydrochloride|Given orally
12074734|NCT00042809|Other|laboratory biomarker analysis|Correlative studies
12074735|NCT00042809|Other|pharmacological study|Correlative studies
12074736|NCT00042796|Drug|decitabine|Given IV
12074737|NCT00042796|Other|pharmacological study|Correlative studies
12074738|NCT00042796|Other|laboratory biomarker analysis|Correlative studies
12074739|NCT00042783|Biological|D1/3-MAGE-3-His fusion protein|
12074740|NCT00042783|Biological|SB-AS02B adjuvant|
12074741|NCT00042770|Other|talc|Given intrapleurally
12074742|NCT00042770|Procedure|dyspnea management|No talc
12074743|NCT00042731|Dietary Supplement|Lycopene|Daily administration as outlined in treatment arm(s)
12074744|NCT00042731|Dietary Supplement|Multivitamin|Daily administration as outlined in treatment arm(s)
12074745|NCT00042731|Dietary Supplement|Soy isoflavones|Daily administration as outlined in treatment arm(s)
12074747|NCT00041340|Drug|imatinib mesylate|Given orally
12074748|NCT00041340|Other|laboratory biomarker analysis|Correlative studies
12074749|NCT00041327|Biological|filgrastim|5 ug/kg/d
12074750|NCT00041327|Biological|recombinant interferon alfa|9 mU subcutaneously per day for one year
12074751|NCT00041327|Drug|Etoposide|50 mg/m2/day continuous 96 hr infusion, days 1-4
12074752|NCT00041327|Drug|cyclophosphamide|750 mg/m2 IV on day 5
12074753|NCT00041327|Drug|doxorubicin hydrochloride|10 mg/m2/day as a continuous 96-hour infusion days 1-4
12074754|NCT00041327|Drug|lamivudine|150 mg bid
12074755|NCT00041327|Drug|prednisone|60 mg/m2 given orally days 1-5
12074756|NCT00041327|Drug|vincristine sulfate|0.4 mg/m2/day as a 96-hour continuous infusion days 1-4
12074757|NCT00041327|Drug|zidovudine|300 mg bid
12074758|NCT00041314|Drug|carboplatin|
12074759|NCT00041314|Drug|exisulind|
12074760|NCT00041314|Drug|gemcitabine hydrochloride|
12074761|NCT00041301|Other|QoL assessment|qol questionnaires
12074762|NCT00041288|Biological|therapeutic allogeneic lymphocytes|
12074763|NCT00041288|Drug|cyclophosphamide|
12074764|NCT00041288|Drug|cyclosporine|
12074765|NCT00041288|Drug|fludarabine phosphate|
12074766|NCT00041288|Drug|methotrexate|
12074767|NCT00041288|Drug|mycophenolate mofetil|
12074768|NCT00041288|Drug|tacrolimus|
12074769|NCT00041288|Procedure|peripheral blood stem cell transplantation|
12074770|NCT00041288|Radiation|radiation therapy|
12074771|NCT00041262|Drug|cisplatin|
12074772|NCT00041262|Drug|epirubicin hydrochloride|
12074773|NCT00041262|Drug|fluorouracil|
12074774|NCT00041262|Procedure|conventional surgery|
12074775|NCT00041262|Procedure|neoadjuvant therapy|
12074776|NCT00041249|Drug|brostallicin|
12074777|NCT00041236|Drug|exatecan mesylate|
12074778|NCT00041223|Dietary Supplement|IH636 grape seed proanthocyanidin extract|
12074779|NCT00041210|Biological|bleomycin sulfate|
12074780|NCT00041210|Drug|ABVD regimen|
12074781|NCT00041210|Drug|Stanford V regimen|
12074782|NCT00041210|Drug|dacarbazine|
12074783|NCT00041210|Drug|doxorubicin hydrochloride|
12074784|NCT00041210|Drug|etoposide|
12074785|NCT00041210|Drug|mechlorethamine hydrochloride|
12074786|NCT00041210|Drug|prednisone|
12074787|NCT00041210|Drug|vinblastine sulfate|
12074788|NCT00041210|Drug|vincristine sulfate|
12074789|NCT00041210|Radiation|radiation therapy|
12074790|NCT00041197|Drug|imatinib mesylate|Given orally (PO)
12074791|NCT00041197|Other|placebo|Given PO
12074792|NCT00041197|Other|laboratory biomarker analysis|Correlative studies
12074793|NCT00041171|Drug|Hypericum perforatum|
12074794|NCT00041171|Drug|docetaxel|
12074795|NCT00041171|Other|placebo|
12074796|NCT00041132|Biological|filgrastim|5 ug/kg
12074797|NCT00041132|Biological|rituximab|375 mg/m^2 on day 1 of cycles 1-6
12074798|NCT00041132|Drug|cyclophosphamide|300 mg/m^2 on days 2-4 of cycles 1,3,5,7
12074799|NCT00041132|Drug|cytarabine|12 g/m^2 over days 3-4 of cycles 2,4,6,8
12074800|NCT00041132|Drug|dexamethasone|40 mg on days 2-5 and 12-15 of cycles 1,3,5,7
12074801|NCT00041132|Drug|doxorubicin|16.6 mg/m^2/day for days 5-7 of cycles 1,3,5,7
12074802|NCT00041132|Drug|leucovorin|170 mg over days 3-5 of cycles 2,4,6,8
12074803|NCT00041132|Drug|methotrexate|1000 mg/m^2 over days 2-3 of cycles 2,4,6,8
12074804|NCT00041132|Drug|vincristine|1.4 mg/m^2 on days 5 and 12 of cycles 1,3,5,7
12074805|NCT00041119|Drug|AC regimen|Given IV
12074806|NCT00041119|Drug|cyclophosphamide|Given IV
12074807|NCT00041119|Drug|doxorubicin hydrochloride|Given IV
12074808|NCT00041119|Drug|paclitaxel|Given IV
12074809|NCT00041106|Drug|gemcitabine hydrochloride|Given IV
12074810|NCT00041106|Drug|cisplatin|Given IV
12074811|NCT00041106|Drug|gefitinib|Given PO
12074812|NCT00041106|Other|laboratory biomarker analysis|Correlative studies
12074813|NCT00041093|Drug|Docetaxel|Given IV
12074814|NCT00041080|Drug|tamoxifen citrate|Given orally
12074815|NCT00041080|Drug|thalidomide|Given orally
12074816|NCT00041080|Other|laboratory biomarker analysis|Correlative studies
12074817|NCT00041067|Biological|filgrastim|
12074818|NCT00041067|Biological|trastuzumab|
12074819|NCT00041067|Drug|docetaxel|
12074820|NCT00041067|Drug|vinorelbine|
12074821|NCT00041054|Drug|carboplatin|
12074822|NCT00041054|Drug|etoposide|
12074823|NCT00041054|Drug|exisulind|
12074824|NCT00041041|Drug|imatinib mesylate|Given PO
12074825|NCT00041041|Other|laboratory biomarker analysis|Correlative studies
12074826|NCT00041028|Drug|EF5|
12074827|NCT00041028|Other|flow cytometry|
12074828|NCT00041028|Other|immunohistochemistry staining method|
12074829|NCT00041015|Drug|cisplatin|
12074830|NCT00041015|Drug|etoposide|
12074831|NCT00041015|Drug|topotecan hydrochloride|
12074832|NCT00040989|Drug|BAY 56-3722|
12074833|NCT00040989|Procedure|enzyme inhibitor therapy|
12074834|NCT00040950|Biological|rituximab|
12074835|NCT00040950|Drug|agatolimod sodium|
12074836|NCT00040937|Biological|filgrastim|PBSC collection: 10 mcg/kg SQ days 1-10
12074837|NCT00040937|Biological|sargramostim|"PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis
~1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery"
12074838|NCT00040937|Drug|cyclophosphamide|PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
12074839|NCT00040937|Drug|dexamethasone|40 mg/d PO days 1-4, 9-12, 17-20
12074840|NCT00040937|Drug|melphalan|"st trans: 140 mg/m2 IV over 20 mins day -1
~nd trans: 200mg/m2 IV over 20 mins day -1"
12074841|NCT00040937|Drug|prednisone|maint: 50 mg/d PO every other day until progression
12074842|NCT00040937|Drug|thalidomide|ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression
12074843|NCT00040937|Procedure|peripheral blood stem cell transplantation|2-4 x 10^6/kg IV day 0
12074844|NCT00040911|Procedure|electroacupuncture therapy|
12074845|NCT00040911|Procedure|sham intervention|Undergo electroacupuncture therapy to sham points
12074846|NCT00040911|Procedure|quality-of-life assessment|Ancillary studies
12074847|NCT00040898|Dietary Supplement|Sho-saiko-to|
12074848|NCT00040885|Biological|infliximab|
12074849|NCT00040885|Drug|docetaxel|
12074850|NCT00040885|Other|placebo|
12074851|NCT00040872|Biological|filgrastim|
12074852|NCT00040872|Biological|monoclonal antibody 3F8|
12074853|NCT00040872|Biological|sargramostim|
12074854|NCT00040872|Drug|carboplatin|
12074855|NCT00040872|Drug|cisplatin|
12074856|NCT00040872|Drug|cyclophosphamide|
12074857|NCT00040872|Drug|doxorubicin hydrochloride|
12074858|NCT00040872|Drug|etoposide|
12074859|NCT00040872|Drug|isotretinoin|
12074860|NCT00040872|Drug|thiotepa|
12074861|NCT00040872|Drug|topotecan hydrochloride|
12074862|NCT00040872|Drug|vincristine sulfate|
12074863|NCT00040872|Procedure|autologous bone marrow transplantation|
12074864|NCT00040872|Procedure|bone marrow ablation with stem cell support|
12074865|NCT00040872|Procedure|conventional surgery|
12074866|NCT00040872|Procedure|drug resistance inhibition treatment|
12074867|NCT00040872|Procedure|peripheral blood stem cell transplantation|
12074868|NCT00040872|Procedure|syngeneic bone marrow transplantation|
12074869|NCT00040872|Radiation|radiation therapy|
12074870|NCT00040859|Drug|capecitabine|
12074871|NCT00040859|Drug|oxaliplatin|
12074872|NCT00040846|Biological|alemtuzumab|Given IV
12074873|NCT00040846|Drug|fludarabine phosphate|Given IV
12074874|NCT00040846|Radiation|total-body irradiation|Undergo TBI
12074875|NCT00040846|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic HSCT
12074876|NCT00040846|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplantation
12074877|NCT00040846|Drug|mycophenolate mofetil|Given PO
12074878|NCT00040846|Drug|cyclosporine|Given IV or PO
12074879|NCT00040833|Procedure|complementary or alternative medicine procedure|
12074880|NCT00040833|Procedure|pain therapy|
12074881|NCT00040807|Drug|docetaxel|
12074882|NCT00040807|Drug|irinotecan hydrochloride|
12074883|NCT00040794|Drug|paclitaxel|Given IV
12074884|NCT00040794|Drug|carboplatin|Given IV
12074885|NCT00040794|Drug|gefitinib|Given PO
12074886|NCT00040794|Radiation|radiation therapy|Undergo radiotherapy
12074887|NCT00040794|Other|laboratory biomarker analysis|Optional correlative studies
12074888|NCT00040781|Drug|gefitinib|Given orally
12074889|NCT00040781|Other|pharmacological study|Correlative studies
12074890|NCT00040781|Other|laboratory biomarker analysis|Correlative studies
12074891|NCT00040768|Drug|bortezomib|Given IV
12074892|NCT00040755|Drug|rebimastat|Given orally
12074893|NCT00040755|Other|laboratory biomarker analysis|Correlative studies
12074894|NCT00040742|Dietary Supplement|ginger|Given orally
12074895|NCT00040742|Other|placebo|Given orally
12074896|NCT00040690|Biological|filgrastim|
12074897|NCT00040690|Drug|cyclophosphamide|
12074898|NCT00040690|Drug|cytarabine|
12074899|NCT00040690|Drug|doxorubicin hydrochloride|
12074900|NCT00040690|Drug|etoposide|
12074901|NCT00040690|Drug|ifosfamide|
12074902|NCT00040690|Drug|leucovorin calcium|
12074903|NCT00040690|Drug|methotrexate|
12074904|NCT00040690|Drug|vincristine sulfate|
12074905|NCT00040690|Radiation|radiation therapy|
12074906|NCT00039611|Drug|FOLFOX regimen|
12074907|NCT00039611|Drug|fluorouracil|
12074908|NCT00039611|Drug|leucovorin calcium|
12074909|NCT00039611|Drug|oxaliplatin|
12074910|NCT00039585|Drug|imatinib mesylate|
12074911|NCT00039572|Drug|boronophenylalanine-fructose complex|
12074912|NCT00039559|Other|Early detection|CA125 is measured in blood and the longitudinal results interpreted with a statistical algorithm to determine if there has been a significant increase from baseline.
12074913|NCT00039546|Drug|cyclophosphamide|
12074914|NCT00039546|Drug|epirubicin hydrochloride|
12074915|NCT00039546|Drug|gemcitabine hydrochloride|
12074916|NCT00039546|Drug|paclitaxel|
12074917|NCT00039546|Procedure|adjuvant therapy|
12074918|NCT00039520|Drug|docetaxel|
12074919|NCT00039520|Drug|sulindac|
12074920|NCT00039507|Procedure|conventional surgery|
12074921|NCT00039507|Procedure|radiofrequency ablation|
12074922|NCT00039494|Drug|erlotinib hydrochloride|Given orally
12074923|NCT00039494|Radiation|3-dimensional conformal radiation therapy|
12074924|NCT00039494|Drug|temozolomide|Given orally
12074925|NCT00039481|Biological|oblimersen sodium|Given IV
12074926|NCT00039481|Drug|dexrazoxane hydrochloride|Given IV
12074927|NCT00039481|Drug|doxorubicin hydrochloride|Given IV
12074928|NCT00039481|Drug|cyclophosphamide|Given IV
12074929|NCT00039481|Biological|filgrastim|Given SC
12074930|NCT00039481|Other|laboratory biomarker analysis|Correlative studies
12074931|NCT00039481|Other|pharmacological study|Correlative studies
12074932|NCT00039468|Drug|irinotecan hydrochloride|350 or 700 mg/m2 IV every 3 weeks
12074933|NCT00039468|Drug|thalidomide|400mg/day oral
12074934|NCT00039455|Biological|trastuzumab|Given IV
12074935|NCT00039455|Drug|alvocidib|Given IV
12074936|NCT00039455|Other|laboratory biomarker analysis|Correlative studies
12074937|NCT00039455|Other|pharmacological study|Correlative studies
12074938|NCT00039442|Drug|Capecitabine|Given orally
12074939|NCT00039442|Other|Laboratory Biomarker Analysis|Correlative studies
12074940|NCT00039429|Drug|atrasentan hydrochloride|
12074941|NCT00039416|Drug|imatinib mesylate|Given orally
12074942|NCT00039416|Other|laboratory biomarker analysis|Correlative studies
12074943|NCT00039403|Drug|7-hydroxystaurosporine|Given IV
12074944|NCT00039403|Drug|gemcitabine hydrochloride|Given IV
12074945|NCT00039403|Other|pharmacological study|Correlative studies
12074946|NCT00039403|Other|laboratory biomarker analysis|Correlative studies
12074947|NCT00039390|Drug|capecitabine|Given orally (PO)
12074948|NCT00039390|Drug|gefitinib|Given PO
12074949|NCT00039390|Other|pharmacological study|Correlative studies
12074950|NCT00039390|Other|laboratory biomarker analysis|Correlative studies
12074951|NCT00039377|Drug|imatinib mesylate|Given PO
12074952|NCT00039377|Drug|methotrexate|Given IT and IV
12074953|NCT00039377|Drug|vincristine sulfate|Given IV
12074954|NCT00039377|Drug|leucovorin calcium|Given IV and PO
12074955|NCT00039377|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
12074956|NCT00039377|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous PBSCT
12074957|NCT00039377|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSCT
12074958|NCT00039377|Radiation|total-body irradiation|Undergo TBI
12074959|NCT00039377|Drug|tacrolimus|Given IV or PO
12074960|NCT00039377|Biological|filgrastim|Given SC
12074961|NCT00039377|Drug|etoposide|Given IV
12074962|NCT00039377|Drug|cyclophosphamide|Given IV
12074963|NCT00039377|Drug|cytarabine|Given IV
12074964|NCT00039377|Other|laboratory biomarker analysis|Correlative studies
12074965|NCT00039364|Drug|imatinib mesylate|
12074966|NCT00039351|Drug|cyclophosphamide|
12074967|NCT00039351|Drug|prednisone|
12074968|NCT00039351|Drug|vincristine sulfate|
12074969|NCT00039351|Radiation|radiation therapy|
12074970|NCT00039338|Procedure|conventional surgery|Radial hysterectomy
12074971|NCT00039338|Procedure|neoadjuvant chemotherapy|Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
12074972|NCT00039338|Radiation|brachytherapy|Brachytherapy at the end of external radiation. Minimal total dose (external with or without external boost + brachytherapy) of 75 Gy EQD2 to point A. Overall treatment less than 50 days.
12074973|NCT00039338|Radiation|radiation therapy|Between 45-50 Gy, in fractions of 1.8 to 2 Gy.
12074974|NCT00039338|Drug|cisplatin|Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
12074975|NCT00039325|Biological|dendritic cell-MART-1 peptide vaccine|Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6 (for arm A) or 10^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
12074976|NCT00039312|Other|Papanicolaou test|
12074977|NCT00039312|Other|cytology specimen collection procedure|
12074978|NCT00039312|Procedure|annual screening|
12074979|NCT00039312|Procedure|colposcopic biopsy|
12074980|NCT00039312|Procedure|comparison of screening methods|
12074981|NCT00039299|Biological|therapeutic autologous lymphocytes|
12074982|NCT00039286|Procedure|positron emission tomography|
12074983|NCT00039286|Procedure|radionuclide imaging|
12074984|NCT00039286|Radiation|fludeoxyglucose F 18|
12074985|NCT00039273|Biological|panitumumab|
12074986|NCT00039234|Biological|aldesleukin|
12074987|NCT00039234|Drug|histamine dihydrochloride|
12074988|NCT00039208|Drug|fluorouracil|
12074989|NCT00039208|Drug|irinotecan hydrochloride|
12074990|NCT00039208|Drug|leucovorin calcium|
12074991|NCT00039208|Drug|oxaliplatin|
12074992|NCT00039195|Biological|filgrastim|
12074993|NCT00039195|Biological|rituximab|
12074994|NCT00039195|Drug|carboplatin|
12074995|NCT00039195|Drug|cyclophosphamide|
12074996|NCT00039195|Drug|doxorubicin hydrochloride|
12074997|NCT00039195|Drug|etoposide|
12074998|NCT00039195|Drug|ifosfamide|
12074999|NCT00039195|Drug|prednisone|
12075000|NCT00039195|Drug|vincristine sulfate|
12075001|NCT00039195|Procedure|peripheral blood stem cell transplantation|
12075002|NCT00039195|Radiation|radiation therapy|
12075003|NCT00039182|Drug|erlotinib hydrochloride|Given orally
12075004|NCT00039182|Other|laboratory biomarker analysis|Correlative studies
12075005|NCT00039156|Drug|ortataxel|
12075006|NCT00039130|Biological|filgrastim|5 ug/kg/day sub Q injection day 7 until ANC>5000/ul courses II-VII
12075007|NCT00039130|Biological|rituximab|Day 8 course II 50 mg/sq m IV infusion: d 8 course IV & VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion
12075008|NCT00039130|Drug|cyclophosphamide|200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII
12075009|NCT00039130|Drug|cytarabine|1 g/sq m/day IV infusion Days 4 & 5, courses II, IV, VI
12075010|NCT00039130|Drug|dexamethasone|10mg/sq m PO or IV Days 1-5 courses II-VII
12075011|NCT00039130|Drug|doxorubicin hydrochloride|25 mg/sq m/day IV infusion Days 4 & 5 courses III,V, VII
12075012|NCT00039130|Drug|etoposide|80 mg/sq m/day IV infusion Days 4 & 5 courses II, IV, VI
12075013|NCT00039130|Drug|ifosfamide|800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI
12075014|NCT00039130|Drug|leucovorin calcium|25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX <10nM, courses II-VII
12075015|NCT00039130|Drug|methotrexate|1.5 g/sq m IV infusion Day 1 courses II-VII
12075016|NCT00039130|Drug|prednisone|60 mg/sq m PO/day Days 1-7 course I
12075017|NCT00039130|Drug|vincristine sulfate|2 mg IV push Day 1 courses II-VII
12075018|NCT00039130|Drug|Allopurinol|300 mg/day PO Days 1-14, course I
12075019|NCT00039117|Biological|oblimersen sodium|Given IV
12075020|NCT00039117|Drug|cytarabine|Given IV
12075021|NCT00039117|Drug|daunorubicin hydrochloride|Given IV
12075022|NCT00039117|Other|laboratory biomarker analysis|Correlative studies
12075023|NCT00039117|Other|pharmacological study|Correlative studies
12075024|NCT00039104|Drug|rebimastat|Given PO
12075025|NCT00039104|Drug|zoledronic acid|Given IV
12075026|NCT00039104|Other|laboratory biomarker analysis|Correlative studies
12075027|NCT00039091|Biological|ipilimumab|Given IV
12075028|NCT00039078|Radiation|yttrium Y 90 glass microspheres|
12075029|NCT00039052|Biological|interleukin-4 PE38KDEL cytotoxin|
12075030|NCT00039039|Drug|carboplatin|
12075031|NCT00039039|Drug|chemotherapy|
12075032|NCT00039039|Drug|cisplatin|
12075033|NCT00039039|Drug|paclitaxel|
12075034|NCT00039039|Radiation|radiation therapy|
12075035|NCT00037037|Biological|MAGE-10.A2|
12075036|NCT00037037|Biological|MART-1 antigen|
12075037|NCT00037037|Biological|NY-ESO-1 peptide vaccine|
12075038|NCT00037037|Biological|sargramostim|
12075039|NCT00037037|Biological|tyrosinase peptide|
12075040|NCT00037024|Procedure|fatigue assessment and management|
12075041|NCT00037024|Procedure|nutritional support|
12075042|NCT00037024|Procedure|physical therapy|
12075043|NCT00037024|Procedure|psychosocial assessment and care|
12075044|NCT00037024|Procedure|quality-of-life assessment|
12075045|NCT00037011|Biological|beta-glucan|
12075046|NCT00037011|Biological|monoclonal antibody 3F8|
12075047|NCT00036998|Procedure|conventional surgery|
12075048|NCT00036998|Procedure|neoadjuvant therapy|
12075049|NCT00036998|Procedure|thermal ablation therapy|
12075050|NCT00036985|Drug|cyclophosphamide|
12075051|NCT00036985|Drug|doxorubicin hydrochloride|
12075052|NCT00036985|Procedure|conventional surgery|
12075053|NCT00036985|Procedure|neoadjuvant therapy|
12075054|NCT00036985|Procedure|thermal ablation therapy|
12075055|NCT00036972|Biological|cintredekin besudotox|
12075056|NCT00036972|Procedure|adjuvant therapy|
12075057|NCT00036972|Procedure|conventional surgery|
12075058|NCT00036972|Procedure|neoadjuvant therapy|
12075059|NCT00036959|Drug|ABT-751|
12075060|NCT00036946|Biological|ziv-aflibercept|
12075061|NCT00036933|Biological|MUC-2-Globo H-KLH conjugate vaccine|
12075062|NCT00036933|Biological|QS21|
12075063|NCT00036894|Drug|lenalidomide|
12075064|NCT00036881|Dietary Supplement|zinc sulfate|
12075065|NCT00036881|Other|placebo|
12075066|NCT00036868|Biological|trastuzumab|
12075067|NCT00036868|Drug|CMF regimen|
12075068|NCT00036868|Drug|cyclophosphamide|
12075069|NCT00036868|Drug|fluorouracil|
12075070|NCT00036868|Drug|methotrexate|
12075071|NCT00036855|Biological|rituximab|Given IV
12075072|NCT00036855|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
12075073|NCT00036855|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
12075074|NCT00036855|Procedure|peripheral blood stem cell transplantation|Undergo PBSC transplantation
12075075|NCT00036855|Biological|filgrastim|Given subcutaneously
12075076|NCT00036855|Other|laboratory biomarker analysis|Correlative studies
12075077|NCT00036842|Drug|arsenic trioxide|
12075078|NCT00036829|Procedure|pain therapy|
12075079|NCT00036816|Biological|MART-1 antigen|
12075080|NCT00036816|Biological|NA17-A antigen|
12075081|NCT00036816|Biological|gp100 antigen|
12075082|NCT00036816|Biological|tyrosinase peptide|
12075083|NCT00036790|Drug|doxorubicin hydrochloride|
12075084|NCT00036790|Drug|motexafin gadolinium|
12075085|NCT00036777|Drug|carboplatin|Given IV
12075086|NCT00036777|Drug|7-hydroxystaurosporine|Given IV
12075087|NCT00036777|Other|pharmacological study|Correlative studies
12075088|NCT00036764|Drug|ixabepilone|Given IV
12075089|NCT00036764|Other|pharmacogenomic studies|Correlative studies
12075090|NCT00036764|Other|laboratory biomarker analysis|Correlative studies
12075091|NCT00036751|Drug|imatinib mesylate|Given orally
12075092|NCT00036751|Other|laboratory biomarker analysis|Correlative studies
12075093|NCT00036738|Drug|Cyclosporine|Given IV or PO
12075094|NCT00036738|Drug|Dasatinib|Given PO
12075095|NCT00036738|Drug|Fludarabine Phosphate|Given IV
12075096|NCT00036738|Drug|Imatinib Mesylate|Given PO
12075097|NCT00036738|Drug|Mycophenolate Mofetil|Given PO
12075098|NCT00036738|Drug|Nilotinib|Given PO
12075099|NCT00036738|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
12075100|NCT00036738|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC transplantation
12075101|NCT00036738|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
12075102|NCT00036738|Radiation|Total-Body Irradiation|Undergo TBI
12075103|NCT00036712|Procedure|management of therapy complications|
12075104|NCT00036712|Procedure|pain therapy|
12075105|NCT00036686|Dietary Supplement|Soy protein isolate|Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
12075106|NCT00036686|Other|Placebo|Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.
12075107|NCT00033748|Biological|monoclonal antibody 11D10 anti-idiotype|2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
12075108|NCT00033748|Biological|monoclonal antibody 3H1 Alu Gel|2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
12075109|NCT00033709|Drug|temozolomide|
12075110|NCT00033709|Drug|thalidomide|
12075111|NCT00033696|Biological|filgrastim|
12075112|NCT00033696|Drug|carboplatin|
12075113|NCT00033696|Drug|etoposide|
12075114|NCT00033696|Drug|paclitaxel|
12075115|NCT00033696|Drug|topotecan hydrochloride|
12075116|NCT00033696|Radiation|radiation therapy|
12075117|NCT00033683|Drug|CMF regimen|
12075118|NCT00033683|Drug|cyclophosphamide|
12075119|NCT00033683|Drug|docetaxel|
12075120|NCT00033683|Drug|epirubicin hydrochloride|
12075121|NCT00033683|Drug|fluorouracil|
12075122|NCT00033683|Drug|methotrexate|
12075123|NCT00033683|Drug|tamoxifen citrate|
12075124|NCT00033683|Procedure|adjuvant therapy|
12075125|NCT00033683|Radiation|radiation therapy|
12075126|NCT00033657|Drug|cisplatin|"Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29
~Days 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
12075127|NCT00033657|Drug|irinotecan hydrochloride|"Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29
~Days 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
12075128|NCT00033657|Drug|paclitaxel|"Days 1 - 35 : Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29
~Days 63 - 77 : paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles"
12075129|NCT00033657|Procedure|conventional surgery|The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.
12075130|NCT00033657|Radiation|radiation therapy|The total dose to the prescription point was 4500 cGy given in 25 fractions. The patient was treated with one fraction per day with all fields treated per day. 180 cGy was delivered to the isocenter. If the dose to the supraclavicular fossa (SCF) was less than 4500 cGy, a localized photon or electron boost was allowed in order to increase the SCF dose to 4500 cGy, specified at 3 cm depth from the anterior skin surface.
12075131|NCT00033644|Biological|sargramostim|
12075132|NCT00033644|Drug|cisplatin|
12075133|NCT00033644|Drug|dacarbazine|
12075134|NCT00033644|Drug|doxorubicin hydrochloride|
12075135|NCT00033644|Drug|mitomycin C|
12075136|NCT00033631|Radiation|70.2 Gy 3D-CRT/IMRT|Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
12075137|NCT00033631|Radiation|79.2 Gy 3D-CRT/IMRT|Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
12075138|NCT00033618|Drug|ixabepilone|Given IV
12075139|NCT00033618|Other|laboratory biomarker analysis|Correlative studies
12075140|NCT00033605|Drug|octreotide acetate|
12075141|NCT00033605|Other|placebo|
12075142|NCT00033605|Radiation|radiation|
12075143|NCT00033566|Drug|S-3304|
12075144|NCT00033553|Drug|carboplatin|Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
12075145|NCT00033553|Drug|gemcitabine hydrochloride|1000 mg/sq m IV over 30 min days 1 & 8 repeat q 21 days for 2 cycles; then 35 mg/sq m IV over 30 min 2X wk for 7 wks
12075146|NCT00033553|Drug|paclitaxel|225 mg/sq m IV over 3 hrs q 21 days for 2 cycles, then 45 mg/sq m IV over 1 hr q wk for 7 wks
12075147|NCT00033553|Radiation|radiation therapy|3-D XRT 7400 cGy total after induction (during cycles 3-9)
12075148|NCT00033540|Drug|capecitabine|650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
12075149|NCT00033540|Drug|gemcitabine hydrochloride|1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days
12075150|NCT00033514|Biological|trastuzumab|Day 1 4mg/kg IV 2 mg/kg IV weekly.
12075151|NCT00033514|Drug|erlotinib hydrochloride|100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.
12075152|NCT00033488|Other|cytology specimen collection procedure|
12075153|NCT00033488|Procedure|annual screening|
12075154|NCT00033488|Procedure|comparison of screening methods|
12075155|NCT00033475|Biological|therapeutic allogeneic lymphocytes|
12075156|NCT00033449|Drug|gefitinib|Given orally
12075157|NCT00033449|Radiation|radiation therapy|Undergo radiation therapy
12075158|NCT00033449|Drug|cisplatin|Given IV
12075159|NCT00033449|Other|laboratory biomarker analysis|Correlative studies
12075160|NCT00033436|Dietary Supplement|niacinamide|
12075161|NCT00033436|Drug|carbogen|
12075162|NCT00033436|Radiation|radiation therapy|
12075163|NCT00033423|Biological|rituximab|
12075164|NCT00033423|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12075165|NCT00033410|Drug|carboplatin|
12075166|NCT00033410|Drug|paclitaxel|
12075167|NCT00033410|Drug|tirapazamine|
12075168|NCT00033410|Radiation|radiation therapy|
12075169|NCT00033397|Procedure|biopsy|
12075170|NCT00033397|Procedure|magnetic resonance imaging|
12075171|NCT00033397|Procedure|radiomammography|
12075172|NCT00033397|Procedure|ultrasound imaging|
12075173|NCT00033397|Radiation|gadopentetate dimeglumine|
12075174|NCT00033397|Drug|chemotherapy|
12075175|NCT00033371|Drug|Celecoxib|Given 400 mg PO twice a day
12075176|NCT00033371|Other|Placebo|Given PO to match DFMO
12075177|NCT00033371|Drug|eflornithine|Given PO at 0.5 gm/m^2/day rounded down to the nearest 250 mg dose (BSA of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day).
12075178|NCT00033371|Other|Laboratory biomarker analysis|Correlative studies
12075179|NCT00033371|Other|Questionnaire administration|Ancillary studies
12075180|NCT00033358|Drug|medroxyprogesterone|Given intramuscularly
12075181|NCT00033358|Drug|ethinyl estradiol|Given orally
12075182|NCT00033358|Drug|norgestrel|Given orally
12075183|NCT00033358|Other|laboratory biomarker analysis|Correlative studies
12075184|NCT00033345|Drug|Indole-3-carbinol|400 mg pill taken daily
12075185|NCT00033345|Drug|Indole-3-carbinol|800 mg pill taken daily
12075186|NCT00033345|Other|Placebo|Placebo pill taken daily during run-in period
12075187|NCT00033332|Drug|dexamethasone|
12075188|NCT00033332|Drug|pamidronate disodium|
12075191|NCT00033293|Biological|therapeutic immune globulin|Given IV
12075192|NCT00033293|Other|clinical observation|Undergo observation
12075193|NCT00033293|Drug|cyclophosphamide|Given IV
12075194|NCT00033293|Drug|prednisone|Given orally
12075195|NCT00033293|Procedure|magnetic resonance imaging|Correlative studies
12075196|NCT00033293|Other|laboratory biomarker analysis|Correlative studies
12075197|NCT00033293|Drug|Corticotropin-Releasing Hormone|administered subcutaneously
12075198|NCT00033280|Drug|temozolomide|
12075199|NCT00033280|Procedure|neoadjuvant therapy|
12075200|NCT00033280|Radiation|radiation therapy|
12075201|NCT00033267|Drug|temsirolimus|Given IV
12075202|NCT00033254|Radiation|radiation therapy|Undergo conventional radiation therapy
12075203|NCT00033254|Drug|thalidomide|Given orally
12075204|NCT00033254|Procedure|quality-of-life assessment|Ancillary studies
12075205|NCT00033241|Drug|erlotinib hydrochloride|
12075206|NCT00033241|Drug|gemcitabine hydrochloride|
12075207|NCT00033228|Biological|MKC1106-MT|Cancer Vaccine, Immunotherapy, 500 ug
12075208|NCT00033228|Biological|MKC1106-MT|Cancer Vaccine, Immunotherapy, 1000 ug
12075209|NCT00033228|Biological|MKC1106-MT|Cancer Vaccine, Immunotherapy, 1500 ug
12075210|NCT00032188|Biological|aldesleukin|Given subcutaneously
12075211|NCT00032188|Drug|bryostatin 1|Given IV
12075212|NCT00032188|Other|laboratory biomarker analysis|Correlative studies
12075213|NCT00032175|Drug|capecitabine|
12075214|NCT00032175|Drug|gemcitabine hydrochloride|
12075215|NCT00032162|Drug|carboplatin|AUC 6 q4w
12075216|NCT00032162|Drug|pegylated liposomal doxorubicin hydrochloride|20/30/40 mg/qm q4w Dose finding study
12075217|NCT00032149|Biological|bleomycin sulfate|
12075218|NCT00032149|Biological|filgrastim|
12075219|NCT00032149|Drug|cyclophosphamide|
12075220|NCT00032149|Drug|etoposide|
12075221|NCT00032149|Drug|mitoxantrone hydrochloride|
12075222|NCT00032149|Drug|prednisolone|
12075223|NCT00032149|Drug|vincristine sulfate|
12075224|NCT00032136|Drug|exemestane|
12075225|NCT00032136|Drug|tamoxifen citrate|
12075226|NCT00032136|Procedure|adjuvant therapy|
12075227|NCT00032123|Drug|erlotinib hydrochloride|
12075228|NCT00032110|Drug|erlotinib hydrochloride|Given orally
12075229|NCT00032110|Other|pharmacological study|Correlative studies
12075230|NCT00032110|Other|laboratory biomarker analysis|Correlative studies
12075231|NCT00032097|Drug|motexafin gadolinium|
12075232|NCT00032097|Radiation|radiation therapy|
12075233|NCT00032084|Behavioral|smoking cessation intervention|Physician will deliver the smoking cessation advice, reinforce the established quit date (no sooner than seven days after starting bupropion/placebo), and will distribute patient educational materials and all pharmacotherapy
12075234|NCT00032084|Drug|bupropion hydrochloride|150 mg/day on Days 1-3, 300 mg/day on Day 4-77
12075235|NCT00032084|Drug|nicotine|21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.
12075236|NCT00032084|Procedure|psychosocial assessment and care|The nurse/CRA will debrief the patients after the brief physician intervention and will follow-up with a series of 5 phone calls to provide booster advice. All advice will be based on the stage of change model (i.e., tailored to the patient's readiness to quit and/or stay off cigarettes).
12075237|NCT00032058|Procedure|magnetic resonance imaging|
12075238|NCT00032058|Procedure|magnetic resonance spectroscopic imaging|
12075239|NCT00032045|Biological|gp100 antigen|
12075240|NCT00032045|Biological|incomplete Freund's adjuvant|
12075241|NCT00032045|Biological|ipilimumab|
12075242|NCT00032032|Drug|carboplatin|
12075243|NCT00032032|Drug|paclitaxel|
12075244|NCT00032032|Radiation|radiation therapy|
12075245|NCT00032019|Biological|filgrastim|Cycle 1: 300 ug (BW < = 70 kg) or 480ug (BW >70 kg) sub Q injection Day 6 until ANC > 5000/uL after nadir counts Subsequent cycle dosages based on previous cycle toxicity or Day 1 Tx toxicity
12075246|NCT00032019|Biological|rituximab|375 mg/sq m IV infusion Day 1 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 of tx toxicities
12075247|NCT00032019|Drug|cyclophosphamide|750 mg/sq m IV infusion on Day 5 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 treatment toxicities
12075248|NCT00032019|Drug|doxorubicin hydrochloride|10 mg/sq m/day continuous IV infusion on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and Day 1 treatment toxicities
12075249|NCT00032019|Drug|etoposide|50 mg/sq m/day continuous IV infusion Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities
12075250|NCT00032019|Drug|prednisone|60 mg/sq m PO bid days 1-5 of ea cycle
12075251|NCT00032019|Drug|vincristine sulfate|0.4 mg/sq m/day continuous IV infusion uncapped on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities
12075252|NCT00032006|Radiation|brachytherapy|
12075253|NCT00032006|Radiation|radiation therapy|
12075254|NCT00031993|Drug|erlotinib hydrochloride|Given PO
12075255|NCT00031993|Other|laboratory biomarker analysis|Correlative studies
12075256|NCT00031980|Drug|cyclosporine|
12075257|NCT00031967|Drug|therapeutic melatonin|
12075258|NCT00031967|Radiation|radiation therapy|
12075259|NCT00031941|Drug|lenalidomide|
12075260|NCT00031928|Drug|mafosfamide|
12075261|NCT00031915|Drug|imatinib mesylate|
12075262|NCT00031902|Biological|bleomycin sulfate|
12075263|NCT00031902|Biological|rituximab|
12075264|NCT00031902|Drug|prednisolone|
12075265|NCT00031902|Drug|vincristine sulfate|
12075266|NCT00031876|Drug|capecitabine|
12075267|NCT00031876|Drug|paclitaxel|
12075268|NCT00031863|Drug|rofecoxib|
12075269|NCT00031863|Procedure|adjuvant therapy|
12075270|NCT00031850|Drug|goserelin acetate|
12075271|NCT00031850|Drug|raloxifene|
12075272|NCT00031837|Drug|dalteparin|
12075273|NCT00031837|Drug|gemcitabine hydrochloride|
12075274|NCT00031837|Procedure|quality-of-life assessment|
12075275|NCT00031824|Drug|cyclosporine|
12075276|NCT00031824|Drug|hydroxychloroquine|
12075277|NCT00031824|Drug|prednisone|
12075278|NCT00031824|Drug|tacrolimus|
12075279|NCT00031798|Drug|methylphenidate hydrochloride|
12075280|NCT00031798|Procedure|quality-of-life assessment|
12075281|NCT00031798|Radiation|radiation therapy|
12075282|NCT00031772|Procedure|psychosocial assessment and care|Questionnaire and telephone intervention
12075283|NCT00031759|Drug|imiquimod|
12075284|NCT00031759|Procedure|Ablative or excisional therapy|
12075285|NCT00031746|Dietary Supplement|soy protein isolate|25 mg daily
12075286|NCT00031746|Dietary Supplement|casein proteins|25 mg daily
12075287|NCT00031733|Biological|MART-1 antigen|
12075288|NCT00031733|Biological|gp100 antigen|
12075289|NCT00031733|Biological|incomplete Freund's adjuvant|
12075290|NCT00031733|Biological|recombinant interleukin-12|
12075291|NCT00031733|Biological|sargramostim|
12075292|NCT00031733|Biological|tyrosinase peptide|
12075293|NCT00031733|Drug|alum adjuvant|
12075294|NCT00031733|Procedure|adjuvant therapy|
12075295|NCT00031720|Dietary Supplement|soy protein|Given orally
12075296|NCT00031720|Dietary Supplement|isoflavones|Given orally
12075297|NCT00031720|Drug|Tamoxifen|
12075298|NCT00031720|Other|Placebo|Oral
12075299|NCT00031694|Drug|paclitaxel|Given IV
12075300|NCT00031694|Drug|bryostatin 1|Given IV
12075301|NCT00031681|Drug|7-hydroxystaurosporine|Given IV
12075302|NCT00031681|Drug|irinotecan hydrochloride|Given IV
12075303|NCT00031681|Other|diagnostic laboratory biomarker analysis|Correlative studies
12075304|NCT00031655|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic PBSCT
12075305|NCT00031655|Biological|donor lymphocytes|Given IV
12075306|NCT00031655|Drug|cyclosporine|Given PO
12075307|NCT00031655|Radiation|total-body irradiation|Undergo TBI
12075308|NCT00031655|Drug|fludarabine phosphate|Given IV
12075309|NCT00031655|Drug|mycophenolate mofetil|Given PO
12075310|NCT00031655|Other|laboratory biomarker analysis|Correlative studies
12075311|NCT00031655|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSCT
12075312|NCT00031642|Biological|rituximab|
12075313|NCT00031642|Radiation|yttrium Y 90 ibritumomab tiuxetan|
12075314|NCT00031629|Drug|Docetaxel|Given IV
12075315|NCT00031629|Biological|Filgrastim|Given SC
12075316|NCT00031629|Drug|Gemcitabine Hydrochloride|Given IV
12075317|NCT00031629|Biological|Pegfilgrastim|Given IV
12075318|NCT00031616|Drug|brivudine phosphoramidate|
12075319|NCT00031590|Drug|Cisplatin|Given at a dose of 70mg/m2 by intravenous (IV) infusion over 8 hours on day 0 of each cycle (Regimen A only).
12075320|NCT00031590|Drug|Cyclophosphamide|Given at a dose of 1g/m2/day by IV infusion on days 0 and 1 of a 6-week cycle. Administration of cyclophosphamide will always be preceded by prehydration and Mesna (Regimen B only).
12075321|NCT00031590|Drug|Etoposide|Given at a dose of 150mg/m2/day by IV infusion on days 0 and 1 of a 6-week cycle. Given orally at a dose of 50mg/m2 as a single daily dose for 21 days beginning on day 14 of a cycle (Regimen B only).
12075322|NCT00031590|Drug|Lomustine|Given at a dose of 75mg/m2 taken orally on days 0 of each 6-week cycle with vincristine and cisplatin (Regimen A only).
12075323|NCT00031590|Drug|Vincristine|Given at a dose of 1.5mg/m2 given by IV infusion once a week for the first six weeks of treatment during radiation therapy. During maintenance therapy, it will be given as an IV push on days 0, 7 and 14 of each 6-week cycle (Regimen A only).
12075324|NCT00031590|Radiation|Craniospinal Radiation|Craniospinal radiation will begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with chemotherapy (vincristine).
12075325|NCT00031577|Drug|paclitaxel|
12075326|NCT00031577|Radiation|radiation therapy|
12075327|NCT00031564|Biological|Interleukin-2|
12075328|NCT00031564|Biological|B7-1|
12075329|NCT00030914|Drug|medroxyprogesterone|
12075330|NCT00030914|Drug|venlafaxine|
12075331|NCT00030901|Drug|L-selenomethionine|Randomization between active L-selenomethionine and placebo
12075332|NCT00030901|Drug|L-selenomethionine placebo|Randomization between active L-selenomethionine and placebo
12075333|NCT00030888|Drug|7-hydroxystaurosporine|
12075334|NCT00030875|Drug|bortezomib|
12075335|NCT00030862|Drug|cisplatin|
12075336|NCT00030862|Drug|irinotecan hydrochloride|
12075337|NCT00030849|Biological|recombinant interferon alfa|
12075338|NCT00030849|Drug|bexarotene|
12075339|NCT00030823|Biological|Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine|
12075340|NCT00030823|Biological|QS21|
12075341|NCT00030810|Radiation|Hyperfractionated|Hyperfractionated radiotherapy
12075342|NCT00030810|Drug|Taxotere/Cisplatin|Taxotere/Cisplatin
12075343|NCT00030810|Procedure|conventional surgery|conventional surgery
12075344|NCT00030784|Drug|ifosfamide|
12075345|NCT00030784|Drug|pegylated liposomal doxorubicin hydrochloride|
12075346|NCT00030771|Drug|Chemotherapy|Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days
12075347|NCT00030771|Radiation|Radiotherapy|Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
12075348|NCT00030771|Procedure|Surgery|3-4 weeks after termination of radiotherapy
12075349|NCT00030758|Biological|filgrastim|
12075350|NCT00030758|Biological|pegfilgrastim|
12075351|NCT00030745|Drug|cisplatin|
12075352|NCT00030745|Drug|gemcitabine hydrochloride|
12075353|NCT00030745|Procedure|conventional surgery|
12075354|NCT00030732|Drug|Gemcitabine + Capecitabine|Gemcitabine + Capecitabine
12075355|NCT00030732|Drug|Gemcitabine alone|Gemcitabine alone
12075357|NCT00030719|Biological|monoclonal antibody Ch14.18|
12075358|NCT00030719|Drug|busulfan|
12075359|NCT00030719|Drug|carboplatin|
12075360|NCT00030719|Drug|cyclophosphamide|
12075361|NCT00030719|Drug|etoposide|
12075362|NCT00030719|Drug|isotretinoin|
12075363|NCT00030719|Drug|melphalan|
12075364|NCT00030719|Drug|vincristine sulfate|
12075365|NCT00030719|Procedure|bone marrow ablation with stem cell support|
12075366|NCT00030719|Procedure|conventional surgery|
12075367|NCT00030719|Procedure|peripheral blood stem cell transplantation|
12075368|NCT00030719|Radiation|radiation therapy|
12075369|NCT00030706|Drug|ixabepilone|
12075370|NCT00030693|Biological|recombinant fowlpox-B7.1 vaccine|Given intratumorally
12075371|NCT00030693|Biological|recombinant fowlpox-TRICOM vaccine|Given intratumorally
12075372|NCT00030693|Other|laboratory biomarker analysis|Correlative studies
12075373|NCT00030693|Procedure|quality-of-life assessment|Ancillary studies
12075374|NCT00030680|Radiation|radiation therapy|
12075375|NCT00030654|Drug|bicalutamide|
12075376|NCT00030654|Drug|docetaxel|
12075377|NCT00030654|Drug|doxorubicin hydrochloride|
12075378|NCT00030654|Drug|estramustine phosphate sodium|
12075379|NCT00030654|Drug|flutamide|
12075380|NCT00030654|Drug|ketoconazole|
12075381|NCT00030654|Drug|paclitaxel|
12075382|NCT00030654|Drug|releasing hormone agonist therapy|
12075383|NCT00030654|Drug|vinblastine sulfate|
12075384|NCT00030641|Biological|oblimersen sodium|
12075385|NCT00030641|Drug|docetaxel|
12075386|NCT00030628|Radiation|radiation therapy|
12075387|NCT00030628|Procedure|surgery|
12075388|NCT00030628|Radiation|WBRT|
12075389|NCT00030615|Drug|decitabine|Given IV
12075390|NCT00030615|Other|pharmacological study|Correlative studies
12075391|NCT00030615|Other|laboratory biomarker analysis|Correlative studies
12075392|NCT00030589|Drug|bexarotene|
12075393|NCT00030589|Drug|methoxsalen|
12075394|NCT00030589|Procedure|UV light therapy|
12075395|NCT00030576|Drug|cisplatin|
12075396|NCT00030576|Drug|erlotinib hydrochloride|
12075397|NCT00030563|Drug|irinotecan hydrochloride|
12075398|NCT00030563|Procedure|adjuvant therapy|
12075399|NCT00030563|Procedure|conventional surgery|
12075400|NCT00030563|Procedure|radiofrequency ablation|
12075401|NCT00030550|Drug|thalidomide|
12075402|NCT00030537|Drug|erlotinib hydrochloride|
12075403|NCT00030511|Drug|fluorouracil|
12075404|NCT00030511|Procedure|conventional surgery|
12075405|NCT00030511|Radiation|radiation therapy|
12075406|NCT00030498|Drug|erlotinib hydrochloride|Given orally
12075407|NCT00030498|Other|laboratory biomarker analysis|Correlative studies
12075408|NCT00030485|Drug|erlotinib hydrochloride|
12075409|NCT00030472|Drug|pegylated liposomal doxorubicin hydrochloride|
12075410|NCT00030459|Drug|cisplatin|
12075411|NCT00030459|Drug|mitomycin C|
12075412|NCT00030459|Drug|vinblastine sulfate|
12075413|NCT00030459|Drug|vinorelbine tartrate|
12075414|NCT00030433|Drug|gemcitabine hydrochloride|
12075415|NCT00030433|Drug|irinotecan hydrochloride|
12075416|NCT00030407|Drug|Celecoxib|On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals
12075417|NCT00030407|Drug|Docetaxel|On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.
12075418|NCT00030394|Drug|imatinib mesylate|Given orally
12075419|NCT00030394|Other|laboratory biomarker analysis|Correlative studies
12075420|NCT00030394|Other|pharmacological study|Correlative studies
12075421|NCT00030355|Drug|homoharringtonine|
12075422|NCT00030355|Procedure|chemotherapy|
12075423|NCT00030342|Biological|recombinant interferon alfa|
12075424|NCT00030342|Biological|sargramostim|
12075425|NCT00030342|Biological|therapeutic autologous lymphocytes|
12075426|NCT00030342|Drug|fluorouracil|
12075427|NCT00030303|Biological|recombinant 70-kD heat-shock protein|
12075428|NCT00030290|Procedure|high-intensity focused ultrasound ablation|
12075429|NCT00030277|Procedure|high-intensity focused ultrasound ablation|
12075430|NCT00030264|Drug|Methotrexate|Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first)
12075431|NCT00030264|Drug|Vinblastine|Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg.
12075432|NCT00030108|Drug|ixabepilone|
12075433|NCT00030095|Drug|2-methoxyestradiol|
12075434|NCT00030082|Drug|isolated perfusion|
12075435|NCT00030082|Drug|melphalan|
12075436|NCT00029029|Procedure|pain therapy|
12075437|NCT00029029|Procedure|radiofrequency ablation|
12075438|NCT00029003|Drug|gefitinib|Given orally
12075439|NCT00029003|Other|laboratory biomarker analysis|Correlative studies
12075440|NCT00028990|Drug|bevacizumab|10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle
12075441|NCT00028990|Drug|Paclitaxel|90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest
12075442|NCT00028977|Drug|herba scutellaria barbata|
12075443|NCT00028977|Other|herba scutellaria Barbatae (HSB)|
12075444|NCT00028964|Dietary Supplement|Chinese herbs|
12075445|NCT00028964|Drug|cyclophosphamide|
12075446|NCT00028964|Drug|doxorubicin hydrochloride|
12075447|NCT00028964|Procedure|adjuvant therapy|
12075448|NCT00028951|Drug|fibrin sealant|
12075449|NCT00028951|Procedure|surgical wound closure|
12075450|NCT00028912|Drug|bortezomib|
12075451|NCT00028912|Drug|carboplatin|
12075454|NCT00028899|Drug|gemtuzumab ozogamicin|
12075455|NCT00028899|Drug|mitoxantrone hydrochloride|
12075456|NCT00028886|Biological|filgrastim|
12075457|NCT00028886|Biological|recombinant interferon alfa|
12075458|NCT00028886|Drug|cyclophosphamide|
12075459|NCT00028886|Drug|dexamethasone|
12075460|NCT00028886|Drug|doxorubicin hydrochloride|
12075461|NCT00028886|Drug|melphalan|
12075462|NCT00028886|Drug|thalidomide|
12075463|NCT00028886|Drug|vincristine sulfate|
12075464|NCT00028886|Procedure|bone marrow ablation with stem cell support|
12075465|NCT00028886|Procedure|peripheral blood stem cell transplantation|
12075466|NCT00028873|Drug|docetaxel|
12075467|NCT00028873|Drug|laniquidar|
12075468|NCT00028873|Drug|paclitaxel|
12075469|NCT00028860|Biological|filgrastim|
12075470|NCT00028860|Drug|carboplatin|
12075471|NCT00028860|Drug|gemcitabine hydrochloride|
12075472|NCT00028860|Drug|ifosfamide|
12075473|NCT00028860|Drug|paclitaxel|
12075474|NCT00028860|Procedure|adjuvant therapy|
12075475|NCT00028847|Drug|cytarabine|
12075476|NCT00028847|Drug|imatinib mesylate|
12075477|NCT00028834|Drug|gemcitabine hydrochloride|Given IV
12075478|NCT00028834|Biological|bevacizumab|Given IV
12075479|NCT00028834|Other|laboratory biomarker analysis|Correlative studies
12075480|NCT00028821|Drug|2-methoxyestradiol|Given orally
12075481|NCT00028821|Other|pharmacological study|Correlative studies
12075482|NCT00028821|Other|laboratory biomarker analysis|Correlative studies
12075483|NCT00028795|Drug|temozolomide|
12075484|NCT00028795|Procedure|adjuvant therapy|
12075485|NCT00028795|Radiation|radiation therapy|
12075486|NCT00028782|Drug|etanidazole|Given IV
12075487|NCT00028782|Procedure|therapeutic conventional surgery|Undergo surgery
12075488|NCT00028782|Other|laboratory biomarker analysis|Correlative studies
12075489|NCT00028769|Drug|bicalutamide|
12075490|NCT00028769|Drug|estramustine|
12075491|NCT00028769|Drug|etoposide|
12075492|NCT00028769|Drug|flutamide|
12075493|NCT00028769|Drug|goserelin|
12075494|NCT00028769|Drug|leuprolide|
12075495|NCT00028769|Drug|nilutamide|
12075496|NCT00028769|Drug|paclitaxel|
12075497|NCT00028756|Drug|doxorubicin hydrochloride|Given IV
12075498|NCT00028756|Drug|gemcitabine hydrochloride|Given IV
12075499|NCT00028756|Drug|vinblastine sulfate|Given IV
12075500|NCT00028756|Drug|methotrexate|Given IV
12075501|NCT00028756|Drug|cisplatin|Given IV
12075502|NCT00028756|Biological|filgrastim|Given SC
12075503|NCT00028743|Drug|carboplatin|Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle
12075504|NCT00028743|Drug|cisplatin|4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle
12075505|NCT00028743|Drug|paclitaxel|Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle
12075506|NCT00028743|Drug|topotecan hydrochloride|"4 cycles
~.75mg/m2 (30 mins) days 1-5 of 21 day cycle"
12075507|NCT00028730|Biological|anti-thymocyte globulin|
12075508|NCT00028730|Biological|filgrastim|
12075509|NCT00028730|Drug|cyclophosphamide|
12075510|NCT00028730|Drug|fludarabine phosphate|
12075511|NCT00028730|Drug|thiotepa|
12075512|NCT00028730|Procedure|allogeneic bone marrow transplantation|
12075513|NCT00028730|Radiation|radiation therapy|
12075514|NCT00028717|Biological|filgrastim|
12075515|NCT00028717|Biological|rituximab|
12075516|NCT00028717|Drug|cyclophosphamide|
12075517|NCT00028717|Drug|doxorubicin hydrochloride|
12075518|NCT00028717|Drug|prednisone|
12075519|NCT00028717|Drug|vincristine sulfate|
12075520|NCT00028704|Procedure|conventional surgery|
12075521|NCT00028704|Radiation|radiation therapy|
12075522|NCT00028691|Drug|chlorambucil|
12075523|NCT00028691|Radiation|radiation therapy|
12075524|NCT00028665|Biological|filgrastim|Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.
12075525|NCT00028665|Biological|rituximab|rituximab IV over 2-5 hours on days 1, 8, and 15
12075526|NCT00028665|Drug|carmustine|After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3
12075527|NCT00028665|Drug|cisplatin|After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.
12075528|NCT00028665|Drug|cyclophosphamide|cyclophosphamide IV over 3-6 hours on day 16.
12075529|NCT00028665|Drug|etoposide|After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.
12075530|NCT00028665|Procedure|bone marrow ablation with stem cell support|Patients then undergo peripheral blood stem cell (PBSC) collection.
12075531|NCT00028665|Procedure|peripheral blood stem cell transplantation|Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.
12075532|NCT00028665|Radiation|radiation therapy|Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.
12075533|NCT00028652|Biological|interleukin-12 gene|
12075534|NCT00028639|Drug|bortezomib|
12075535|NCT00028626|Drug|embolization therapy|
12075536|NCT00028600|Biological|filgrastim|PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC >= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC > 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2
12075537|NCT00028600|Biological|CD34+ cells|2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant
12075538|NCT00028600|Drug|cyclophosphamide|4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep
12075539|NCT00028600|Drug|fludarabine phosphate|30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl
12075540|NCT00028600|Drug|melphalan|200mg/sq m IV infusion over 15-30 min D 2 auto transpl
12075541|NCT00028600|Drug|methotrexate|5mg/sq m/d IV infusion D 1,3,& 6: allo transpl
12075542|NCT00028600|Drug|tacrolimus|0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150
12075543|NCT00028587|Drug|bortezomib|Given IV
12075544|NCT00028587|Drug|paclitaxel|Given IV
12075545|NCT00028587|Drug|carboplatin|Given IV
12075546|NCT00028587|Other|laboratory biomarker analysis|Optional correlative studies
12075547|NCT00028574|Drug|gabapentin|
12075548|NCT00028574|Other|placebo|
12075549|NCT00028561|Drug|ixabepilone|Given IV
12075550|NCT00028561|Drug|carboplatin|Given IV
12075551|NCT00028561|Other|laboratory biomarker analysis|Correlative studies
12075552|NCT00028561|Other|pharmacological study|Correlative studies
12075553|NCT00028548|Drug|R(+)XK469|
12075554|NCT00028535|Biological|trastuzumab|Given IV
12075555|NCT00028535|Drug|paclitaxel|Given IV
12075556|NCT00028535|Biological|recombinant interleukin-12|Given SC
12075557|NCT00028522|Drug|R(+)XK469|Given IV
12075558|NCT00028509|Procedure|management of therapy complications|
12075559|NCT00028496|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|Given intradermally
12075560|NCT00028496|Biological|sargramostim|Given subcutaneously
12075561|NCT00028496|Biological|recombinant fowlpox GM-CSF vaccine adjuvant|Given intradermally
12075562|NCT00028028|Drug|temsirolimus|Given IV
12075563|NCT00028028|Other|pharmacological study|Correlative studies
12075564|NCT00028028|Other|laboratory biomarker analysis|Correlative studies
12075565|NCT00028015|Drug|SarCNU|
12075566|NCT00028002|Procedure|Conventional Surgery|Undergo surgical resection
12075567|NCT00028002|Drug|Imatinib Mesylate|Given orally
12075568|NCT00027989|Drug|gemcitabine hydrochloride|
12075569|NCT00027989|Drug|pegylated liposomal doxorubicin hydrochloride|
12075570|NCT00027976|Drug|celecoxib|
12075571|NCT00027976|Drug|Placebo|
12075572|NCT00027963|Drug|gabapentin|
12075573|NCT00027963|Other|placebo|
12075574|NCT00027937|Biological|aldesleukin|
12075575|NCT00027937|Biological|filgrastim|
12075576|NCT00027937|Biological|sargramostim|
12075577|NCT00027937|Drug|busulfan|
12075578|NCT00027937|Drug|cyclophosphamide|
12075579|NCT00027937|Drug|melphalan|
12075580|NCT00027937|Drug|paclitaxel|
12075581|NCT00027937|Drug|thiotepa|
12075582|NCT00027937|Procedure|bone marrow ablation with stem cell support|
12075583|NCT00027937|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12075584|NCT00027911|Biological|NY-ESO-1 peptide vaccine|
12075585|NCT00027911|Biological|sargramostim|
12075586|NCT00027898|Drug|bortezomib|Given IV
12075587|NCT00027898|Drug|carboplatin|Given IV
12075588|NCT00027898|Drug|etoposide|Given IV
12075589|NCT00027898|Other|laboratory biomarker analysis|Correlative studies
12075590|NCT00027898|Other|pharmacological study|Correlative studies
12075591|NCT00027885|Biological|bevacizumab|Patients receive bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
12075592|NCT00027885|Drug|cyclophosphamide|Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
12075593|NCT00027885|Drug|docetaxel|Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
12075594|NCT00027885|Drug|doxorubicin hydrochloride|Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
12075595|NCT00027885|Procedure|adjuvant therapy|"After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
~Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
12075596|NCT00027885|Procedure|conventional surgery|After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.
12075597|NCT00027885|Procedure|neoadjuvant therapy|"Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
~Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
12075598|NCT00027885|Radiation|radiation therapy|Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
12075599|NCT00027872|Drug|tipifarnib|Given orally
12075600|NCT00027872|Other|laboratory biomarker analysis|Correlative studies
12075601|NCT00027859|Drug|docetaxel|
12075602|NCT00027859|Drug|estramustine phosphate sodium|
12075603|NCT00027859|Drug|ketoconazole|
12075604|NCT00027859|Drug|therapeutic hydrocortisone|
12075605|NCT00027846|Biological|filgrastim|Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
12075606|NCT00027846|Drug|carboplatin|Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA <0.45m2 the dose is 12.5 mg/kg/day.
12075607|NCT00027846|Drug|cyclophosphamide|Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.
12075608|NCT00027846|Drug|etoposide|Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA < 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.
12075609|NCT00027846|Drug|vincristine sulfate|Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA<0.45m2 the dose is 0.05mg/kg.
12075610|NCT00027846|Radiation|radiation therapy|Given once daily 5 days a week for 6-6½ weeks
12075611|NCT00027846|Drug|Mesna|Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.
12075612|NCT00027846|Procedure|therapeutic conventional surgery|
12075613|NCT00027833|Biological|ALVAC-CEA-B7.1 vaccine|
12075614|NCT00027833|Biological|tetanus toxoid|
12075615|NCT00027833|Drug|FOLFIRI regimen|
12075616|NCT00027833|Drug|fluorouracil|
12075617|NCT00027833|Drug|irinotecan hydrochloride|
12075618|NCT00027833|Drug|leucovorin calcium|
12075619|NCT00027820|Drug|Fludarabine Phosphate|Given IV
12075620|NCT00027820|Radiation|Total-Body Irradiation|Undergo TBI
12075621|NCT00027820|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo nonmyeloablative PBSCT
12075622|NCT00027820|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo nonmyeloablative PBSCT
12075623|NCT00027820|Drug|Cyclosporine|Given PO
12075624|NCT00027820|Drug|Mycophenolate Mofetil|Given PO
12075625|NCT00027807|Biological|Aldesleukin|Subcutaneous injections of IL-2 (3.0 × 105 IU/m2/day) starting 3 days before the 1st armed ATC infusion and ending 7 days after the last armed ATC infusion.
12075626|NCT00027807|Biological|Sargramostim|GM-CSF Injections will be given SQ GM-CSF (250 μg/m2/twice weekly), to start 3 days before the first ATC infusion and ending 1 week after the last ATC infusion.
12075627|NCT00027807|Biological|therapeutic autologous lymphocytes|The time for armed-ATC infusions will vary from patient to patient, but the dose of armed-ATC (up to 40 billion) will be given over 30 min.
12075628|NCT00027794|Procedure|conventional surgery|
12075629|NCT00027781|Drug|sabarubicin|
12075630|NCT00027768|Procedure|adjuvant therapy|
12075631|NCT00027768|Radiation|iodine I 131 ethiodized oil|
12075632|NCT00027742|Biological|pegylated interferon alfa|
12075633|NCT00027742|Drug|temozolomide|
12075634|NCT00027729|Biological|etaracizumab|
12075635|NCT00027716|Drug|bortezomib|
12075636|NCT00027703|Drug|gemcitabine hydrochloride|Given IV
12075637|NCT00027703|Drug|cisplatin|Given IV
12075638|NCT00027703|Biological|bevacizumab|Given IV
12075639|NCT00027703|Other|placebo|Given IV
12075640|NCT00027703|Other|laboratory biomarker analysis|Correlative studies
12075641|NCT00027690|Drug|Gefitinib|Given orally
12075642|NCT00027690|Other|Laboratory Biomarker Analysis|Correlative studies
12075643|NCT00027677|Drug|halofuginone hydrobromide|
12075644|NCT00027664|Biological|recombinant interferon alfa|
12075645|NCT00027664|Drug|thalidomide|
12075646|NCT00027638|Drug|thalidomide|
12075647|NCT00027625|Drug|gefitinib|
12075648|NCT00027625|Drug|temozolomide|
12075649|NCT00027586|Drug|Imatinib mesylate (STI571)|400 mg twice a day orally
12075650|NCT00027573|Biological|filgrastim|
12075651|NCT00027573|Biological|therapeutic allogeneic lymphocytes|
12075652|NCT00027573|Drug|cyclophosphamide|
12075653|NCT00027573|Drug|fludarabine phosphate|
12075654|NCT00027573|Drug|methotrexate|
12075655|NCT00027573|Drug|tacrolimus|
12075656|NCT00027573|Procedure|peripheral blood stem cell transplantation|
12075657|NCT00027560|Biological|alemtuzumab|"Consenting individuals will receive pretransplant immunosuppressive cytoreduction, which will consist of 4 days of Campath-1H, 5 days of fludarabine, and two days of melphalan. All therapy should be completed approximately 24-36 hours before administration of the primary allograft.
~Campath-1H (20mg/dose/day) will be administered for each of four days from day -8 to day -5, inclusive. Each dose will be infused intravenously over 8 hours."
12075658|NCT00027560|Drug|cyclosporine|Patients will be treated with Cyclosporine as prophylaxis against GvHD. Cyclosporine will be initiated at least 1 day prior to transplant at a dose of 1.5 mg / kg IV q12h (3 mg / kg / day = total daily dose). Dose will thereafter be adjusted to maintain a trough serum level of 200-300 ng /ml. Cyclosporine will be administered intravenously until the patient tolerates full alimentation, at which time conversion to oral dosing to sustain therapeutic levels will be initiated according to standard BMT service guidelines.
12075659|NCT00027560|Drug|fludarabine phosphate|Fludarabine, 25mg/m2/d will be administered for each of five days from day -8 to day -4, inclusive. Each dose will be infused intravenously over 30 minutes.
12075660|NCT00027560|Drug|melphalan|Melphalan will be administered intravenously over 30 minutes on each of two days from day -3 to day -2, inclusive. The dose for recipients of HLA-matched related grafts will be 50 mg/m2/day x 2. The dose for recipients of HLA-matched unrelated and HLA-single allele disparate related or unrelated marrow or PBSC transplants will be 70 mg/m2/day x 2.
12075661|NCT00027560|Procedure|allogeneic bone marrow transplantation|
12075662|NCT00027560|Procedure|peripheral blood stem cell transplantation|
12075663|NCT00027547|Biological|therapeutic allogeneic lymphocytes|
12075664|NCT00027547|Drug|cyclosporine|
12075665|NCT00027547|Drug|cytarabine|
12075666|NCT00027547|Drug|fludarabine phosphate|
12075667|NCT00027547|Drug|methotrexate|
12075668|NCT00027547|Drug|mycophenolate mofetil|
12075669|NCT00027547|Procedure|allogeneic bone marrow transplantation|
12075670|NCT00027547|Procedure|peripheral blood stem cell transplantation|
12075671|NCT00027547|Radiation|radiation therapy|
12075672|NCT00027534|Biological|TRICOM-CEA(6D)|dendritic cells loaded with TRICOM-CEA(6D)
12075673|NCT00027495|Dietary Supplement|curcumin|
12075674|NCT00026533|Drug|thalidomide|
12075675|NCT00026494|Drug|temozolomide|
12075676|NCT00026494|Drug|vinorelbine tartrate|
12075677|NCT00026468|Drug|exisulind|
12075678|NCT00026442|Drug|capecitabine|
12075679|NCT00026416|Biological|recombinant interferon alfa|
12075680|NCT00026416|Drug|thalidomide|
12075681|NCT00026416|Procedure|adjuvant therapy|
12075682|NCT00026403|Drug|cisplatin|
12075683|NCT00026403|Drug|gemcitabine hydrochloride|
12075684|NCT00026403|Radiation|radiation therapy|
12075685|NCT00026338|Drug|erlotinib hydrochloride|150 mg po daily
12075686|NCT00026338|Drug|gemcitabine hydrochloride|1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)
12075687|NCT00026312|Biological|Aldesleukin|Given IV
12075688|NCT00026312|Biological|Dinutuximab|Given IV
12075689|NCT00026312|Drug|Isotretinoin|Given PO
12075690|NCT00026312|Other|Laboratory Biomarker Analysis|Correlative studies
12075691|NCT00026312|Other|Pharmacological Study|Correlative studies
12075692|NCT00026312|Other|Quality-of-Life Assessment|Ancillary studies
12075693|NCT00026312|Biological|Sargramostim|Given IV or SC
12075694|NCT00026299|Drug|ZD1839|
12075695|NCT00026299|Drug|oxaliplatin|
12075696|NCT00026247|Procedure|pain therapy|
12075697|NCT00026247|Procedure|radiofrequency ablation|
12075698|NCT00026234|Drug|floxuridine|Given intra-arterially
12075699|NCT00026234|Drug|dexamethasone|Given intra-arterially
12075700|NCT00026234|Drug|oxaliplatin|Given IV
12075701|NCT00026234|Drug|capecitabine|Given orally
12075702|NCT00026221|Biological|Recombinant Interferon Alfa|Given SC
12075703|NCT00026221|Biological|Bevacizumab|Given IV
12075704|NCT00026208|Drug|Vincristine|1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
12075705|NCT00026208|Drug|Cyclophosphamide|650 mg/m², on week 1 and 5
12075706|NCT00026208|Drug|Doxorubicin|25 mg/m², on week 1, 3, 5, 7
12075707|NCT00026208|Drug|Prednisone|40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
12075708|NCT00026208|Drug|Bleomycin|5 u/m² intravenously (IV) on week 2, 4, 6, 8
12075709|NCT00026208|Drug|Etoposide|60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
12075710|NCT00026208|Radiation|Low-dose radiotherapy (RT)|20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
12075711|NCT00026195|Drug|irinotecan hydrochloride|
12075712|NCT00026182|Biological|rituximab|Given IV
12075713|NCT00026182|Biological|recombinant interleukin-12|Given SC
12075714|NCT00026182|Other|laboratory biomarker analysis|Correlative studies
12075715|NCT00026182|Other|questionnaire administration|Ancillary studies
12075716|NCT00026182|Procedure|quality-of-life assessment|Ancillary studies
12075717|NCT00026169|Drug|imatinib mesylate|Given orally
12075718|NCT00026169|Other|laboratory biomarker analysis|Correlative studies
12075719|NCT00026169|Other|pharmacological study|Correlative studies
12075720|NCT00026156|Drug|docetaxel|
12075721|NCT00026156|Drug|vinorelbine tartrate|
12075722|NCT00026143|Biological|recombinant interleukin-12|Given IV
12075723|NCT00026143|Biological|recombinant interferon alfa|Given SC
12075724|NCT00026143|Other|laboratory biomarker analysis|Correlative studies
12075725|NCT00026130|Drug|fluorouracil|200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
12075726|NCT00026130|Drug|gemcitabine hydrochloride|200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle
12075727|NCT00026130|Radiation|radiation therapy|4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)
12075728|NCT00026117|Drug|BenFin|
12075729|NCT00026117|Other|placebo|
12075730|NCT00026104|Drug|gemcitabine hydrochloride|Given IV
12075731|NCT00026104|Drug|paclitaxel|Given IV
12075732|NCT00026104|Drug|tipifarnib|Given orally
12075733|NCT00026104|Radiation|radiation therapy|Undergo radiation therapy
12075734|NCT00026091|Drug|fenretinide|Given orally
12075735|NCT00026091|Other|laboratory biomarker analysis|Correlative studies
12075736|NCT00026091|Other|pharmacological study|Correlative studies
12075737|NCT00026078|Drug|docetaxel|
12075738|NCT00026078|Drug|ifosfamide|
12075739|NCT00025675|Drug|gefitinib|
12075740|NCT00025662|Drug|RFT5-SMPT-dgA|A specific anti-interleukin-2 receptor immunotoxin
12075741|NCT00025662|Drug|Isolex system|CD34 selection/ T cell depletion used this system
12075742|NCT00025649|Biological|filgrastim|
12075743|NCT00025649|Drug|busulfan|
12075744|NCT00025649|Drug|carboplatin|
12075745|NCT00025649|Drug|cyclophosphamide|
12075746|NCT00025649|Drug|doxorubicin hydrochloride|
12075747|NCT00025649|Drug|etoposide|
12075748|NCT00025649|Drug|melphalan|
12075749|NCT00025649|Drug|vincristine sulfate|
12075750|NCT00025649|Procedure|autologous bone marrow transplantation|
12075751|NCT00025649|Procedure|conventional surgery|
12075752|NCT00025649|Procedure|peripheral blood stem cell transplantation|
12075753|NCT00025636|Biological|filgrastim|
12075754|NCT00025636|Drug|carmustine|
12075755|NCT00025636|Drug|cisplatin|
12075756|NCT00025636|Drug|cyclophosphamide|
12075757|NCT00025636|Drug|cytarabine|
12075758|NCT00025636|Drug|dexamethasone|
12075759|NCT00025636|Drug|etoposide|
12075760|NCT00025636|Drug|melphalan|
12075761|NCT00025636|Drug|methotrexate|
12075762|NCT00025636|Drug|vincristine sulfate|
12075763|NCT00025636|Procedure|bone marrow ablation with stem cell support|
12075764|NCT00025636|Procedure|peripheral blood stem cell transplantation|
12075765|NCT00025623|Drug|carboplatin|
12075766|NCT00025623|Drug|cyclophosphamide|
12075767|NCT00025623|Drug|doxorubicin hydrochloride|
12075768|NCT00025623|Drug|etoposide|
12075769|NCT00025623|Drug|vincristine sulfate|
12075770|NCT00025623|Procedure|conventional surgery|
12075771|NCT00025610|Drug|carboplatin|
12075772|NCT00025610|Drug|cyclophosphamide|
12075773|NCT00025610|Drug|doxorubicin hydrochloride|
12075774|NCT00025610|Drug|etoposide|
12075775|NCT00025610|Drug|vincristine sulfate|
12075776|NCT00025597|Drug|carboplatin|
12075778|NCT00025597|Drug|doxorubicin hydrochloride|
12075779|NCT00025597|Drug|etoposide|
12075780|NCT00025597|Drug|vincristine sulfate|
12075781|NCT00025597|Procedure|conventional surgery|
12075782|NCT00025584|Drug|bortezomib|Given IV
12075783|NCT00025584|Other|laboratory biomarker analysis|Correlative studies
12075784|NCT00025558|Biological|filgrastim|
12075785|NCT00025558|Drug|carboplatin|
12075786|NCT00025558|Drug|temozolomide|
12075787|NCT00025558|Drug|thiotepa|
12075788|NCT00025558|Procedure|autologous bone marrow transplantation|
12075789|NCT00025558|Procedure|peripheral blood stem cell transplantation|
12075790|NCT00025519|Biological|therapeutic allogeneic lymphocytes|
12075791|NCT00025519|Drug|fludarabine phosphate|
12075792|NCT00025519|Drug|mycophenolate mofetil|
12075793|NCT00025519|Drug|tacrolimus|
12075794|NCT00025519|Drug|thalidomide|
12075795|NCT00025519|Procedure|peripheral blood stem cell transplantation|
12075796|NCT00025519|Radiation|radiation therapy|
12075797|NCT00025506|Other|Laboratory Biomarker Analysis|Correlative studies
12075798|NCT00025506|Drug|Thalidomide|Given orally
12075799|NCT00025493|Drug|docetaxel|
12075800|NCT00025480|Drug|carboplatin|
12075801|NCT00025480|Drug|paclitaxel|
12075802|NCT00025480|Drug|tipifarnib|
12075803|NCT00025480|Radiation|radiation therapy|
12075804|NCT00025454|Drug|tipifarnib|
12075805|NCT00025441|Biological|dactinomycin|
12075806|NCT00025441|Biological|filgrastim|
12075807|NCT00025441|Drug|carboplatin|
12075808|NCT00025441|Drug|cyclophosphamide|
12075809|NCT00025441|Drug|doxorubicin hydrochloride|
12075810|NCT00025441|Drug|epirubicin hydrochloride|
12075811|NCT00025441|Drug|etoposide|
12075812|NCT00025441|Drug|ifosfamide|
12075813|NCT00025441|Drug|vincristine sulfate|
12075814|NCT00025441|Procedure|peripheral blood stem cell transplantation|
12075815|NCT00025441|Radiation|radiation therapy|
12075816|NCT00025428|Drug|carboplatin|
12075817|NCT00025428|Drug|cyclophosphamide|
12075818|NCT00025428|Drug|doxorubicin hydrochloride|
12075819|NCT00025428|Drug|etoposide|
12075820|NCT00025428|Drug|vincristine sulfate|
12075821|NCT00025428|Procedure|adjuvant therapy|
12075822|NCT00025428|Procedure|conventional surgery|
12075823|NCT00025428|Procedure|neoadjuvant therapy|
12075824|NCT00025415|Drug|imatinib mesylate|Given orally
12075825|NCT00025415|Other|pharmacological study|Correlative studies
12075826|NCT00025402|Biological|filgrastim|
12075827|NCT00025402|Biological|recombinant interferon alfa|
12075828|NCT00025402|Drug|busulfan|
12075829|NCT00025402|Drug|cyclophosphamide|
12075830|NCT00025402|Drug|cytarabine|
12075831|NCT00025402|Drug|etoposide|
12075832|NCT00025402|Drug|hydroxyurea|
12075833|NCT00025402|Drug|idarubicin|
12075834|NCT00025402|Procedure|allogeneic bone marrow transplantation|
12075835|NCT00025402|Procedure|peripheral blood stem cell transplantation|
12075836|NCT00025402|Radiation|radiation therapy|
12075837|NCT00025389|Biological|bevacizumab|
12075838|NCT00025389|Drug|carboplatin|
12075839|NCT00025389|Drug|paclitaxel|
12075840|NCT00025389|Procedure|conventional surgery|
12075841|NCT00025389|Procedure|neoadjuvant therapy|
12075842|NCT00025363|Drug|vincristine sulfate|Given IV
12075843|NCT00025363|Drug|irinotecan hydrochloride|Given IV
12075844|NCT00025363|Drug|cyclophosphamide|Given IV
12075845|NCT00025363|Drug|doxorubicin hydrochloride|Given IV
12075846|NCT00025363|Drug|ifosfamide|Given IV
12075847|NCT00025363|Drug|etoposide|Given IV
12075848|NCT00025363|Drug|tirapazamine|Given IV
12075849|NCT00025363|Biological|filgrastim|Given SC
12075850|NCT00025363|Biological|sargramostim|Given SC
12075851|NCT00025363|Other|pharmacological study|Correlative studies
12075852|NCT00025363|Other|pharmacogenomic studies|Correlative studies
12075853|NCT00025363|Other|laboratory biomarker analysis|Correlative studies
12075854|NCT00025337|Biological|bevacizumab|Given IV
12075855|NCT00025337|Drug|oxaliplatin|Given IV
12075856|NCT00025337|Drug|leucovorin calcium|Given IV
12075857|NCT00025337|Drug|fluorouracil|Given IV
12075858|NCT00025324|Biological|filgrastim|
12075859|NCT00025324|Drug|carboplatin|
12075860|NCT00025324|Drug|cyclophosphamide|
12075861|NCT00025324|Drug|etoposide|
12075862|NCT00025324|Drug|thiotepa|
12075863|NCT00025324|Procedure|autologous bone marrow transplantation|
12075864|NCT00025324|Procedure|bone marrow ablation with stem cell support|
12075865|NCT00025324|Procedure|conventional surgery|
12075866|NCT00025324|Procedure|peripheral blood stem cell transplantation|
12075867|NCT00025324|Radiation|radiation therapy|
12075868|NCT00025311|Drug|topotecan hydrochloride|
12075869|NCT00025298|Drug|amifostine trihydrate|
12075870|NCT00025298|Drug|carboplatin|
12075871|NCT00025298|Drug|cisplatin|
12075872|NCT00025298|Drug|paclitaxel|
12075873|NCT00025298|Radiation|radiation therapy|
12075874|NCT00025285|Drug|carboplatin|
12075875|NCT00025285|Drug|irinotecan hydrochloride|
12075876|NCT00025285|Drug|thalidomide|
12075877|NCT00025272|Drug|carboplatin|
12075878|NCT00025272|Drug|etoposide|
12075879|NCT00025272|Drug|topotecan hydrochloride|
12075880|NCT00025272|Radiation|radiation therapy|
12075881|NCT00025259|Biological|Bleomycin Sulfate|Given IV or SC
12075882|NCT00025259|Drug|Cisplatin|Given IV
12075883|NCT00025259|Drug|Cyclophosphamide|Given IV
12075884|NCT00025259|Drug|Cytarabine|Given IV
12075885|NCT00025259|Drug|Dexamethasone|Given IV
12075886|NCT00025259|Drug|Doxorubicin Hydrochloride|Given IV
12075887|NCT00025259|Drug|Etoposide|Given IV
12075888|NCT00025259|Biological|Filgrastim|Given SC
12075889|NCT00025259|Radiation|Involved-Field Radiation Therapy|Undergo IFRT
12075890|NCT00025259|Drug|Prednisone|Given orally
12075891|NCT00025259|Drug|Vincristine Sulfate Liposome|Given IV
12075892|NCT00025246|Drug|imatinib mesylate|Given orally
12075893|NCT00025246|Other|laboratory biomarker analysis|Correlative studies
12075894|NCT00025233|Biological|bevacizumab|Given IV
12075895|NCT00025233|Other|laboratory biomarker analysis|Correlative studies
12075896|NCT00025220|Drug|Thalidomide|Given PO
12075897|NCT00025220|Other|Laboratory Biomarker Analysis|Correlative studies
12075898|NCT00025194|Drug|estramustine phosphate sodium|
12075899|NCT00025194|Drug|ixabepilone|
12075900|NCT00025181|Biological|MART-1 antigen|
12075901|NCT00025181|Biological|gp100 antigen|
12075902|NCT00025181|Biological|incomplete Freund's adjuvant|
12075903|NCT00025181|Biological|ipilimumab|
12075904|NCT00025181|Biological|tyrosinase peptide|
12075905|NCT00025181|Procedure|adjuvant therapy|
12075906|NCT00025168|Drug|gemcitabine hydrochloride|
12075907|NCT00025168|Drug|irinotecan hydrochloride|
12075908|NCT00025168|Radiation|radiation therapy|
12075909|NCT00025155|Drug|ixabepilone|Given IV
12075910|NCT00025142|Drug|FOLFOX regimen|
12075911|NCT00025142|Drug|fluorouracil|
12075912|NCT00025142|Drug|gefitinib|
12075913|NCT00025142|Drug|leucovorin calcium|
12075914|NCT00025142|Drug|oxaliplatin|
12075915|NCT00025129|Drug|laromustine|
12075916|NCT00025103|Biological|dactinomycin|
12075917|NCT00025103|Drug|carboplatin|
12075918|NCT00025103|Drug|cyclophosphamide|
12075919|NCT00025103|Drug|doxorubicin hydrochloride|
12075920|NCT00025103|Drug|etoposide|
12075921|NCT00025103|Drug|melphalan|
12075922|NCT00025103|Drug|vincristine sulfate|
12075923|NCT00025103|Procedure|autologous bone marrow transplantation|
12075924|NCT00025103|Procedure|conventional surgery|
12075925|NCT00025103|Procedure|peripheral blood stem cell transplantation|
12075926|NCT00025103|Radiation|radiation therapy|
12075927|NCT00025090|Drug|cisplatin|
12075928|NCT00025090|Drug|fluorouracil|
12075929|NCT00025090|Drug|mitomycin C|
12075930|NCT00025090|Radiation|radiation therapy|
12075931|NCT00025077|Biological|filgrastim|
12075932|NCT00025077|Drug|carboplatin|
12075933|NCT00025077|Drug|cyclophosphamide|
12075934|NCT00025077|Drug|thiotepa|
12075935|NCT00025077|Procedure|conventional surgery|
12075936|NCT00025077|Procedure|peripheral blood stem cell transplantation|
12075937|NCT00025077|Radiation|radiation therapy|
12075938|NCT00025064|Biological|bleomycin sulfate|
12075939|NCT00025064|Drug|chlorambucil|
12075940|NCT00025064|Drug|cisplatin|
12075941|NCT00025064|Drug|dacarbazine|
12075942|NCT00025064|Drug|doxorubicin hydrochloride|
12075943|NCT00025064|Drug|etoposide|
12075944|NCT00025064|Drug|ifosfamide|
12075945|NCT00025064|Drug|melphalan|
12075946|NCT00025064|Drug|prednisolone|
12075947|NCT00025064|Drug|procarbazine hydrochloride|
12075948|NCT00025064|Drug|vinblastine sulfate|
12075949|NCT00025064|Drug|vincristine sulfate|
12075950|NCT00025064|Procedure|peripheral blood stem cell transplantation|
12075951|NCT00025064|Radiation|radiation therapy|
12075952|NCT00025051|Drug|celecoxib|
12075953|NCT00025051|Procedure|anti-cytokine therapy|
12075954|NCT00025051|Procedure|antiangiogenesis therapy|
12075955|NCT00025051|Procedure|biological therapy|
12075956|NCT00025051|Procedure|cancer prevention intervention|
12075957|NCT00025051|Procedure|chemoprevention of cancer|
12075958|NCT00025051|Procedure|growth factor antagonist therapy|
12075959|NCT00025038|Drug|tipifarnib|Given orally
12075960|NCT00025038|Drug|isotretinoin|Given orally
12075961|NCT00025038|Drug|fludarabine phosphate|Given IV
12075962|NCT00025038|Drug|cytarabine|Given IV
12075963|NCT00025038|Radiation|radiation therapy|Undergo total body irradiation
12075964|NCT00025038|Drug|cyclophosphamide|Given IV
12075965|NCT00025038|Biological|anti-thymocyte globulin|Given IV
12075966|NCT00025038|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow transplant
12075967|NCT00025038|Procedure|double-unit umbilical cord blood transplantation|
12075968|NCT00025038|Procedure|umbilical cord blood transplantation|Undergo allogeneic cord blood transplant
12075969|NCT00025038|Other|laboratory biomarker analysis|Correlative studies
12075970|NCT00025025|Other|sample testing|
12075971|NCT00024466|Biological|GVAX|
12075972|NCT00024466|Procedure|Autologous transplant|
12075973|NCT00024453|Biological|teicoplanin|
12075974|NCT00024440|Biological|filgrastim|
12075975|NCT00024440|Biological|oblimersen sodium|
12075976|NCT00024440|Drug|cyclophosphamide|
12075977|NCT00024440|Drug|fludarabine phosphate|
12075978|NCT00024427|Drug|fluorouracil|High dose 5-FU
12075979|NCT00024427|Drug|gemcitabine hydrochloride|Normal dose to treat pancreatic cancer
12075980|NCT00024427|Drug|triacetyluridine|6 grams (12 tablets)
12075981|NCT00024414|Drug|DHA-paclitaxel|
12075982|NCT00024375|Drug|DHA-paclitaxel|
12075983|NCT00024349|Drug|fluorouracil|
12075984|NCT00024349|Drug|mitomycin C|
12075985|NCT00024349|Radiation|radiation therapy|
12075986|NCT00024336|Drug|tamoxifen citrate|
12075987|NCT00024336|Radiation|radiation therapy|
12075988|NCT00024297|Drug|warfarin|
12075989|NCT00024284|Drug|carboplatin|
12075990|NCT00024284|Drug|irinotecan hydrochloride|
12075991|NCT00024271|Biological|recombinant interferon gamma|
12075992|NCT00024271|Drug|cisplatin|
12075993|NCT00024271|Drug|doxorubicin hydrochloride|
12075994|NCT00024271|Drug|gemcitabine hydrochloride|
12075995|NCT00024271|Drug|mitomycin C|
12075996|NCT00024271|Procedure|conventional surgery|
12075997|NCT00024271|Procedure|hyperthermia treatment|
12075998|NCT00024271|Radiation|radiation therapy|
12075999|NCT00024258|Drug|arsenic trioxide|
12076000|NCT00024245|Drug|pralatrexate|
12076001|NCT00024245|Drug|probenecid|
12076002|NCT00024232|Biological|monoclonal antibody huJ591|
12076003|NCT00024193|Biological|filgrastim|
12076004|NCT00024193|Drug|busulfan|
12076005|NCT00024193|Drug|cisplatin|
12076006|NCT00024193|Drug|cyclophosphamide|
12076007|NCT00024193|Drug|doxorubicin hydrochloride|
12076008|NCT00024193|Drug|etoposide|
12076009|NCT00024193|Drug|melphalan|
12076010|NCT00024193|Drug|vincristine sulfate|
12076011|NCT00024193|Procedure|conventional surgery|
12076012|NCT00024193|Procedure|peripheral blood stem cell transplantation|
12076013|NCT00024180|Drug|romidepsin|
12076014|NCT00024167|Drug|Docetaxel|75 mg/m2 intravenous piggyback (IVPB) over 1 hour, Day 1, every 3 weeks.
12076015|NCT00024167|Drug|Doxorubicin hydrochloride|20 mg/m2 IV, day 1 on Weeks 1, 3, 5
12076016|NCT00024167|Drug|Estramustine phosphate sodium|140 mg orally 3 x day, Days 1 through 7 on Weeks 2, 4, 6
12076017|NCT00024167|Drug|Ketoconazole|400 mg orally (po) 3 x day, Days 1 through 7
12076018|NCT00024167|Drug|Prednisone|5 mg orally 2 x daily, weeks 1-14
12076019|NCT00024167|Drug|Vinblastine|4 mg/m2 IVPB, Day 1 on Weeks 2, 4, 6
12076020|NCT00024167|Radiation|Strontium chloride Sr 89|One dose (4 mCi total dose) IV
12076021|NCT00024167|Drug|Dexamethasone|4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
12076022|NCT00024154|Biological|trastuzumab|Given IV
12076023|NCT00024154|Drug|gefitinib|Given orally
12076024|NCT00024154|Other|laboratory biomarker analysis|Correlative studies
12076025|NCT00024115|Drug|BL22 immunotoxin|
12076026|NCT00024115|Procedure|antibody therapy|
12076027|NCT00024115|Procedure|biological response modifier therapy|
12076028|NCT00024115|Procedure|immunotoxin therapy|
12076029|NCT00024102|Drug|Standard Treatment|Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 & 8 and 5-FU 600 mg/sq m IV push d 1 & 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles
12076030|NCT00024102|Drug|capecitabine|2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles
12076031|NCT00024089|Drug|gefitinib|
12076032|NCT00024076|Procedure|radiofrequency ablation|
12076033|NCT00024050|Drug|busulfan|
12076034|NCT00024050|Drug|cyclophosphamide|
12076035|NCT00024050|Drug|cyclosporine|
12076036|NCT00024050|Drug|methotrexate|
12076037|NCT00024050|Procedure|allogeneic bone marrow transplantation|
12076038|NCT00024050|Procedure|peripheral blood stem cell transplantation|
12076039|NCT00023998|Drug|doxorubicin hydrochloride|Given IV
12076040|NCT00023998|Drug|cisplatin|Given IV
12076041|NCT00023998|Drug|methotrexate|Given IV
12076042|NCT00023998|Drug|leucovorin calcium|Given IV or orally
12076043|NCT00023998|Biological|filgrastim|Given IV
12076044|NCT00023998|Procedure|therapeutic conventional surgery|Undergo resection
12076045|NCT00023998|Radiation|radiation therapy|Undergo radiotherapy
12076046|NCT00023998|Drug|etoposide|Given IV
12076047|NCT00023998|Drug|ifosfamide|Given IV
12076048|NCT00023998|Biological|trastuzumab|Given IV
12076049|NCT00023998|Other|laboratory biomarker analysis|Correlative studies
12076050|NCT00023985|Biological|autologous tumor cell vaccine|
12076051|NCT00023985|Biological|therapeutic autologous dendritic cells|
12076052|NCT00023985|Procedure|conventional surgery|
12076053|NCT00023972|Drug|exatecan mesylate|
12076054|NCT00023972|Drug|gemcitabine hydrochloride|
12076055|NCT00023959|Drug|hydroxyurea|Given orally
12076056|NCT00023959|Drug|fluorouracil|Given IV
12076057|NCT00023959|Biological|bevacizumab|Given IV
12076058|NCT00023959|Radiation|radiation therapy|Undergo radiotherapy
12076059|NCT00023959|Biological|filgrastim|Given subcutaneously
12076060|NCT00023959|Other|laboratory biomarker analysis|Correlative studies
12076061|NCT00023946|Drug|ixabepilone|Given IV
12076062|NCT00023946|Other|laboratory biomarker analysis|Correlative studies
12076063|NCT00023920|Biological|bevacizumab|Given IV
12076064|NCT00023920|Drug|idarubicin|Given IV
12076065|NCT00023920|Drug|cytarabine|Given SC
12076066|NCT00023894|Drug|alvocidib|
12076067|NCT00023881|Drug|bortezomib|
12076068|NCT00023855|Drug|bortezomib|
12076069|NCT00023855|Drug|doxorubicin hydrochloride|
12076070|NCT00023842|Biological|BCG vaccine|
12076071|NCT00023842|Drug|mitomycin C|
12076072|NCT00023842|Procedure|adjuvant therapy|
12076073|NCT00023842|Procedure|conventional surgery|
12076074|NCT00023829|Drug|bicalutamide|
12076075|NCT00023829|Drug|flutamide|
12076076|NCT00023829|Drug|releasing hormone agonist therapy|
12076077|NCT00023829|Procedure|adjuvant therapy|
12076078|NCT00023829|Radiation|radiation therapy|
12076079|NCT00023790|Drug|silicon phthalocyanine 4|Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of Pc 4.
12076080|NCT00023777|Biological|filgrastim|induction: 5 mcg/kg/d IV or SC starting apx day 15
12076081|NCT00023777|Biological|sargramostim|induction: 250 mcg/m2/d IV or SC starting apx day 1
12076082|NCT00023777|Drug|cytarabine|ind: 200 mg/m2/d continuous IV days 1-7 consol: 200 mg/m2/d continuous IV days 1-5
12076083|NCT00023777|Drug|daunorubicin hydrochloride|ind and consol: 45 mg/m2/d continuous IV days 1-3
12076084|NCT00023764|Drug|bortezomib|Given IV
12076085|NCT00023751|Drug|fluorouracil|
12076086|NCT00023751|Drug|leucovorin calcium|
12076087|NCT00023751|Procedure|conventional surgery|
12076088|NCT00023751|Radiation|radiation therapy|
12076089|NCT00023712|Drug|bortezomib|Given IV
12076090|NCT00023712|Other|laboratory biomarker analysis|Correlative studies
12076091|NCT00023712|Other|pharmacological study|Correlative studies
12076092|NCT00023686|Procedure|surgery|
12076093|NCT00023686|Radiation|radiation|
12076094|NCT00023660|Drug|celecoxib|
12076095|NCT00023660|Drug|cisplatin|
12076096|NCT00023660|Drug|fluorouracil|
12076097|NCT00023660|Radiation|brachytherapy|
12076098|NCT00023660|Radiation|radiation therapy|
12076099|NCT00023634|Biological|KLH|100 mcg w/EGFRvIII
12076100|NCT00023634|Biological|GMCSF|arm 1: 100 mcg w/EGFRvIII
12076101|NCT00023621|Drug|celecoxib|
12076102|NCT00022737|Biological|filgrastim|Given SC
12076103|NCT00022737|Drug|asparaginase|Given IM
12076104|NCT00022737|Drug|cyclophosphamide|Given IV
12076105|NCT00022737|Drug|cyclosporine|Given IV
12076106|NCT00022737|Drug|cytarabine|Given IT and IV
12076107|NCT00022737|Drug|daunorubicin hydrochloride|Given IV
12076108|NCT00022737|Drug|dexamethasone|Given orally
12076109|NCT00022737|Drug|etoposide|Given IV
12076110|NCT00022737|Drug|ifosfamide|Given IV
12076111|NCT00022737|Drug|imatinib mesylate|Given orally
12076112|NCT00022737|Drug|leucovorin calcium|Given IV or orally
12076113|NCT00022737|Drug|mercaptopurine tablet|Given orally
12076114|NCT00022737|Drug|methotrexate|Given IT, IV, and orally
12076115|NCT00022737|Drug|pegaspargase|Given IM
12076116|NCT00022737|Drug|vincristine sulfate|Given IV
12076117|NCT00022737|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
12076118|NCT00022737|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
12076119|NCT00022737|Procedure|umbilical cord blood transplantation|Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
12076120|NCT00022737|Radiation|radiation therapy|Undergo radiation therapy
12076121|NCT00022724|Drug|temsirolimus|
12076122|NCT00022711|Drug|temozolomide|150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months
12076123|NCT00022698|Drug|Capecitabine|
12076124|NCT00022698|Drug|Irinotecan|
12076125|NCT00022685|Biological|epratuzumab|
12076126|NCT00022672|Drug|trastuzumab (Herceptin®)|4mg/kg iv loading dose, followed by 2mg/kg iv weekly
12076127|NCT00022672|Drug|anastrazole (Arimidex®)|1 mg tablet taken orally daily
12076128|NCT00022659|Biological|bevacizumab|Given IV
12076129|NCT00022659|Other|laboratory biomarker analysis|Correlative studies
12076130|NCT00022646|Drug|gemcitabine hydrochloride|
12076131|NCT00022646|Drug|pemetrexed disodium|
12076132|NCT00022633|Drug|gemcitabine hydrochloride|
12076133|NCT00022633|Drug|paclitaxel|
12076134|NCT00022620|Drug|paclitaxel|
12076135|NCT00022607|Biological|bevacizumab|
12076136|NCT00022607|Drug|thalidomide|
12076137|NCT00022581|Drug|thalidomide|Given orally
12076138|NCT00022581|Other|laboratory biomarker analysis|Correlative studies
12076139|NCT00022568|Biological|recombinant vaccinia-TRICOM vaccine|
12076140|NCT00022555|Drug|bryostatin 1|Given IV
12076141|NCT00022555|Drug|vincristine sulfate|Given IV
12076142|NCT00022516|Drug|Cyclophosphamide|50 mg/day orally continuously for 1 year
12076143|NCT00022516|Drug|Methotrexate|2.5 mg twice/day orally days 1 and 2 of every week for 1 year
12076144|NCT00022490|Drug|cytarabine|Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
12076145|NCT00022490|Drug|imatinib mesylate|Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.
12076146|NCT00022464|Drug|temsirolimus|
12076147|NCT00022451|Drug|tipifarnib|
12076148|NCT00022438|Biological|aldesleukin|
12076149|NCT00022438|Biological|incomplete Freund's adjuvant|
12076150|NCT00022438|Biological|recombinant tyrosinase-related protein-2|
12076151|NCT00022425|Drug|perillyl alcohol|
12076152|NCT00022412|Dietary Supplement|doxercalciferol|Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
12076153|NCT00022412|Procedure|conventional surgery|Procedure: Prostatectomy for prostate cancer
12076154|NCT00022399|Drug|celecoxib|400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
12076155|NCT00022399|Drug|Placebos|Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
12076156|NCT00022334|Biological|AFP|Increasing doses of AFP will be given to groups of 3 intradermally. Subjects will receive 3 biweekly vaccinations. At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated.
12076157|NCT00022295|Drug|idronoxil|
12076158|NCT00022230|Biological|aldesleukin|
12076159|NCT00022230|Biological|filgrastim|
12076160|NCT00022230|Biological|sargramostim|
12076161|NCT00022230|Biological|therapeutic autologous lymphocytes|
12076162|NCT00022230|Drug|cyclophosphamide|
12076163|NCT00022230|Drug|doxorubicin hydrochloride|
12076164|NCT00022230|Drug|paclitaxel|
12076165|NCT00022191|Drug|cisplatin|
12076166|NCT00022191|Drug|gemcitabine hydrochloride|
12076167|NCT00022191|Drug|paclitaxel|
12076168|NCT00022152|Drug|vinorelbine tartrate|
12076169|NCT00022126|Drug|asparaginase|
12076173|NCT00022126|Drug|daunorubicin hydrochloride|
12076174|NCT00022126|Drug|dexamethasone|
12076175|NCT00022126|Drug|doxorubicin hydrochloride|
12076176|NCT00022126|Drug|mercaptopurine|
12076177|NCT00022126|Drug|methotrexate|
12076178|NCT00022126|Drug|methylprednisolone|
12076179|NCT00022126|Drug|pegaspargase|
12076180|NCT00022126|Drug|thioguanine|
12076181|NCT00022126|Drug|vincristine sulfate|
12076182|NCT00022126|Procedure|allogeneic bone marrow transplantation|
12076183|NCT00022126|Radiation|radiation therapy|
12076184|NCT00022113|Drug|cilengitide|Given IV
12076185|NCT00022113|Other|pharmacological study|Correlative studies
12076186|NCT00022113|Other|laboratory biomarker analysis|Correlative studies
12076187|NCT00022087|Dietary Supplement|calcium salts|1000 mg PO per day
12076188|NCT00022087|Dietary Supplement|cholecalciferol|400 IU PO per day
12076189|NCT00022087|Drug|zoledronic acid|4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
12076190|NCT00022074|Drug|gabapentin|
12076191|NCT00022074|Procedure|quality-of-life assessment|
12076192|NCT00022048|Biological|bevacizumab|
12076193|NCT00022035|Biological|trivalent influenza vaccine|
12076194|NCT00022022|Drug|docetaxel|
12076195|NCT00022022|Procedure|quality-of-life assessment|
12076196|NCT00021450|Drug|bicalutamide|
12076197|NCT00021450|Drug|goserelin acetate|
12076198|NCT00021450|Procedure|adjuvant therapy|
12076199|NCT00021450|Radiation|radiation therapy|
12076200|NCT00021424|Biological|recombinant fowlpox-TRICOM vaccine|
12076201|NCT00021320|Drug|cisplatin|
12076202|NCT00021320|Drug|fluorouracil|
12076203|NCT00021320|Drug|paclitaxel|
12076204|NCT00021320|Procedure|conventional surgery|
12076205|NCT00021320|Procedure|neoadjuvant therapy|
12076206|NCT00021320|Radiation|radiation therapy|
12076207|NCT00021255|Drug|Doxorubicin|
12076208|NCT00021255|Drug|Cyclophosphamide|
12076209|NCT00021255|Drug|Docetaxel|
12076210|NCT00021255|Drug|Herceptin|
12076211|NCT00021255|Drug|Carboplatin|
12076212|NCT00021242|Drug|docetaxel|Continuous IV infusion
12076213|NCT00021229|Drug|imatinib mesylate|"Phase 1 Stratum I: Starting dose level of 350 mg/m2/day every 28 days X 13 courses (dose escalation)
~Phase I Stratum IIA: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation)
~Phase I Stratum IIB: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation)
~Phase II: Phase I Stratum I determined dose (Maximum tolerated dose) every 28 days X 13 courses."
12076214|NCT00021229|Radiation|local irradiation therapy|"Phase I Stratum I: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib.
~Phase II: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib."
12076215|NCT00021216|Drug|bortezomib|Given IV
12076216|NCT00021216|Other|laboratory biomarker analysis|Correlative studies
12076217|NCT00021216|Other|pharmacological study|Correlative studies
12076218|NCT00021164|Biological|aldesleukin|
12076219|NCT00021164|Biological|incomplete Freund's adjuvant|
12076220|NCT00021164|Biological|telomerase: 540-548 peptide vaccine|
12076221|NCT00021125|Procedure|adjuvant therapy|
12076222|NCT00021125|Radiation|radiation therapy|
12076223|NCT00021112|Drug|cisplatin|
12076224|NCT00021112|Drug|etoposide|
12076225|NCT00021112|Procedure|conventional surgery|
12076226|NCT00021112|Radiation|radiation therapy|
12076227|NCT00021073|Drug|alvocidib|Given IV
12076228|NCT00021073|Drug|leucovorin calcium|Given IV
12076229|NCT00021073|Drug|fluorouracil|Given IV
12076230|NCT00021073|Drug|irinotecan hydrochloride|Given IV
12076231|NCT00021060|Drug|paclitaxel|Given IV
12076232|NCT00021060|Drug|carboplatin|Given IV
12076233|NCT00021060|Biological|bevacizumab|Given IV
12076234|NCT00021060|Other|laboratory biomarker analysis|Correlative studies
12076235|NCT00021047|Drug|capecitabine|
12076236|NCT00021047|Drug|carboplatin|
12076237|NCT00021047|Drug|epirubicin hydrochloride|
12076238|NCT00020995|Procedure|therapeutic dietary intervention|
12076239|NCT00020969|Drug|arsenic trioxide|
12076240|NCT00020943|Biological|filgrastim|5 ug/kg subQ daily day 4 until ANC >10,000 (or ANC> 5000 2X)Tx 1, 2, 4 10 ug/kg subQ daily day 14 until completion of PBSC collection Tx 3
12076241|NCT00020943|Biological|rituximab|375 mg/sq m IV infusion at , or = 400 mg/hr day 1 Tx 1, 2, days 5 & 12 Tx 3, and weekly for 2 doses Tx 5
12076242|NCT00020943|Drug|carmustine|15 mg/kg IV infusion over 2 hours Day 6, Tx 4
12076243|NCT00020943|Drug|cyclophosphamide|2000 mg/sq m IV infusion over 2 hours Day 3, Tx 1 & 2 100 mg/kg IV infusion over 2 hours Day 2, Tx 4
12076244|NCT00020943|Drug|cytarabine|2000 mg/sq m IV infusion BID over 2 hours x 8 doses Days 1-4, Tx 3
12076245|NCT00020943|Drug|doxorubicin hydrochloride|50 mg/sq m IVP Day 3, Tx 1& 2
12076246|NCT00020943|Drug|etoposide|40 mg/kg total dose continuous IV infusion over 96 hours Days 1-4, Tx 3
12076247|NCT00020943|Drug|leucovorin calcium|50 mg/sq m IV infusion q 6 hours x 3 doses after MTX, then 10 mg/sq m IV/PO q 6 hrs until MTX levels <0.05 uM, Tx 1 & 2
12076248|NCT00020943|Drug|methotrexate|300 mg/sq m IV infusion over 4 hrs Day 2 Tx 1 & 2
12076249|NCT00020943|Drug|prednisone|100 mg/sq m PO Days 3-7, Tx 1 & 2
12076250|NCT00020943|Drug|vincristine sulfate|1.4 mg/sq m IVP Day 3, Tx 1 & 2
12076251|NCT00020943|Procedure|peripheral blood stem cell transplantation|Stem cells collected during Tx 3 will be transfused follwing chemotx in Tx 4
12076252|NCT00020891|Procedure|computed tomography|
12076253|NCT00020891|Radiation|radiation therapy|
12076254|NCT00020878|Drug|celecoxib|Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
12076255|NCT00020852|Procedure|conventional surgery|
12076256|NCT00020852|Procedure|cryosurgery|
12076258|NCT00020839|Radiation|radiation therapy|
12076259|NCT00020826|Other|quality-of-life assessment|QLQ-C30 questionnaire administered. STO22 questionnaire administered.
12076260|NCT00020800|Biological|rituximab|
12076261|NCT00020800|Drug|fludarabine phosphate|
12076262|NCT00020761|Drug|irinotecan hydrochloride|"The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
~Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks."
12076263|NCT00020761|Drug|paclitaxel|"The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
~Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks."
12076264|NCT00020748|Drug|epirubicin hydrochloride|
12076265|NCT00020748|Drug|irinotecan hydrochloride|
12076266|NCT00020735|Drug|toremifene|
12076267|NCT00020735|Procedure|conventional surgery|
12076268|NCT00020735|Procedure|neoadjuvant therapy|
12076269|NCT00020722|Biological|therapeutic autologous lymphocytes|"Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.
~The time for ATC infusions will vary from patient to patient, but the infusion rate will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion."
12076270|NCT00020722|Drug|Ifosfamide, carboplatin, and etoposide (ICE) regimen|"Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 mg/m2.
~Carboplatin at a dose of 250 mg/m2 will be given daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 1500 mg/m2.
~VP-16 (etoposide) at a dose of 200 mg/m2 will be given IV on days -8, -7, -6, -5, -4 and -3. The total dose of VP-16 given prior to PBSCT will be 2,400 mg/m2. VP-16 will be given 200 mg/m2"
12076271|NCT00020722|Drug|Cyclophosphamide, Thiotepa, Carboplatin (CTC) or STAMP V (CTC)|"Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -4, -3, and -2 (total = 6000 mg/m2).
~Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -4, -3, -2 (total = 500 mg/m2) as the preparative regimen followed by PBSCT on day 0.
~Carboplatin will be given at a dose of 267 mg/m2 in D5W IV over one hour daily on days -4, -3, and -2.
~Mesna will be administered per BMT Standard of Care Guidelines at a dose of 25% of the total cyclophosphamide dose 30 minutes prior to and then 3, 6, and 9 hours after cyclophosphamide daily on days -4, -3, and -2 prior to PBSCT for a total of 2000mg/m2."
12076272|NCT00020722|Procedure|Leukapheresis|Peripheral blood mononuclear cells (PBMC) will be collected by leukapheresis (for generation of ATC) prior to or post G-CSF (16 ug/kg/day) priming for collecting stem cells.
12076273|NCT00020722|Procedure|peripheral blood stem cell transplantation (PBSCT)|Will be collected either before or after peripheral blood stem cell collection for stem cell transplant.
12076274|NCT00020709|Drug|cisplatin|Given IV
12076275|NCT00020709|Drug|docetaxel|Given IV
12076276|NCT00020709|Drug|etoposide|Given IV
12076277|NCT00020709|Drug|gefitinib|Given orally
12076278|NCT00020709|Radiation|radiation therapy|Undergo radiation therapy
12076279|NCT00020709|Other|placebo|Given orally
12076280|NCT00020683|Drug|incyclinide|High dose given orally
12076281|NCT00020683|Drug|incyclinide|Low dose given orally
12076282|NCT00020683|Other|laboratory biomarker analysis|Correlative studies
12076283|NCT00020670|Biological|CD 40|
12076284|NCT00020657|Drug|dolasetron mesylate|
12076285|NCT00020657|Drug|granisetron hydrochloride|
12076286|NCT00020657|Drug|ondansetron|
12076287|NCT00020657|Drug|prochlorperazine|
12076288|NCT00020657|Procedure|quality-of-life assessment|
12076289|NCT00020644|Drug|gemcitabine hydrochloride|
12076290|NCT00020631|Drug|pirfenidone|
12076291|NCT00020579|Drug|entinostat|
12076292|NCT00020566|Biological|dactinomycin|Given IV
12076293|NCT00020566|Drug|busulfan|Given orally and IV
12076294|NCT00020566|Drug|doxorubicin hydrochloride|Given IV
12076295|NCT00020566|Drug|etoposide|Given IV
12076296|NCT00020566|Drug|ifosfamide|Given IV
12076297|NCT00020566|Drug|melphalan|Given orally and IV
12076298|NCT00020566|Drug|vincristine sulfate|Given IV
12076299|NCT00020566|Procedure|autologous hematopoietic stem cell transplantation|Given IV
12076300|NCT00020566|Procedure|conventional surgery|Given to patients deemed to require it
12076301|NCT00020566|Radiation|radiation therapy|Given to patients deemed to require it
12076302|NCT00020527|Drug|caspofungin acetate|
12076303|NCT00020501|Drug|FOLFIRI regimen|
12076304|NCT00020501|Drug|floxuridine|
12076305|NCT00020501|Drug|fluorouracil|
12076306|NCT00020501|Drug|irinotecan hydrochloride|
12076307|NCT00020501|Drug|leucovorin calcium|
12076308|NCT00020501|Drug|melphalan|
12076309|NCT00020501|Procedure|hyperthermia treatment|
12076310|NCT00020488|Drug|FOLFIRI regimen|
12076311|NCT00020488|Drug|fluorouracil|
12076312|NCT00020488|Drug|irinotecan hydrochloride|
12076313|NCT00020488|Drug|leucovorin calcium|
12076314|NCT00020449|Biological|recombinant interleukin-12|
12076315|NCT00020449|Drug|paclitaxel|
12076316|NCT00020449|Drug|pegylated liposomal doxorubicin hydrochloride|
12076317|NCT00020410|Biological|filgrastim|
12076318|NCT00020410|Procedure|peripheral blood stem cell transplantation|
12076319|NCT00020410|Radiation|yttrium Y 90 monoclonal antibody B3|
12076320|NCT00020397|Biological|NY-ESO-1 peptide vaccine|
12076321|NCT00020397|Biological|aldesleukin|
12076322|NCT00020358|Biological|aldesleukin|
12076323|NCT00020358|Biological|gp100 antigen|
12076324|NCT00020358|Biological|incomplete Freund's adjuvant|
12076325|NCT00020358|Biological|tyrosinase peptide|
12076326|NCT00020332|Drug|alvocidib|
12076327|NCT00020332|Drug|docetaxel|
12076329|NCT00020254|Biological|recombinant fowlpox-prostate specific antigen vaccine|
12076330|NCT00020254|Biological|recombinant vaccinia prostate-specific antigen vaccine|
12076331|NCT00020254|Biological|recombinant vaccinia-B7.1 vaccine|
12076332|NCT00020254|Biological|sargramostim|
12076333|NCT00020254|Drug|nilutamide|
12076334|NCT00020189|Drug|acetylsalicylic acid|
12076335|NCT00020189|Drug|alvocidib|
12076336|NCT00020189|Drug|clopidogrel bisulfate|
12076337|NCT00020176|Biological|filgrastim|
12076338|NCT00020176|Biological|therapeutic allogeneic lymphocytes|
12076339|NCT00020176|Drug|cyclophosphamide|
12076340|NCT00020176|Drug|cyclosporine|
12076341|NCT00020176|Drug|fludarabine phosphate|
12076342|NCT00020176|Procedure|peripheral blood stem cell transplantation|
12076343|NCT00020150|Drug|O6-benzylguanine|
12076344|NCT00020150|Drug|temozolomide|
12076345|NCT00020124|Drug|doxorubicin hydrochloride|
12076346|NCT00020111|Drug|arsenic trioxide|
12076347|NCT00020072|Other|laboratory biomarker analysis|
12076348|NCT00020007|Drug|isolated perfusion|
12076349|NCT00020007|Drug|paclitaxel|
12076350|NCT00020007|Procedure|hyperthermia treatment|
12076351|NCT00019994|Biological|MART-1 antigen|
12076352|NCT00019994|Biological|aldesleukin|
12076353|NCT00019994|Biological|gp100 antigen|
12076354|NCT00019994|Biological|incomplete Freund's adjuvant|
12076355|NCT00019955|Procedure|laparoscopic surgery|
12076356|NCT00019955|Procedure|radiofrequency ablation|
12076357|NCT00019955|Procedure|thermal ablation therapy|
12076358|NCT00019929|Biological|mutant p53 peptide pulsed dendritic cell vaccine|
12076359|NCT00019929|Procedure|adjuvant therapy|
12076360|NCT00019916|Biological|aldesleukin|
12076361|NCT00019916|Biological|p53 peptide vaccine|
12076362|NCT00019916|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12076363|NCT00019864|Biological|filgrastim|
12076364|NCT00019864|Drug|cisplatin|
12076365|NCT00019864|Drug|dexrazoxane hydrochloride|
12076366|NCT00019864|Drug|doxorubicin hydrochloride|
12076367|NCT00019864|Drug|leucovorin calcium|
12076368|NCT00019864|Drug|methotrexate|
12076369|NCT00019864|Procedure|adjuvant therapy|
12076370|NCT00019864|Procedure|conventional surgery|
12076371|NCT00019864|Procedure|neoadjuvant therapy|
12076372|NCT00019838|Drug|7-hydroxystaurosporine|
12076373|NCT00019838|Drug|fludarabine phosphate|
12076374|NCT00019825|Drug|decitabine|
12076375|NCT00019812|Biological|trastuzumab|
12076376|NCT00019812|Drug|paclitaxel|
12076377|NCT00019786|Drug|isolated perfusion|
12076378|NCT00019786|Drug|melphalan|
12076379|NCT00019786|Procedure|conventional surgery|
12076380|NCT00019773|Drug|capecitabine|
12076381|NCT00019773|Drug|oxaliplatin|
12076382|NCT00019747|Drug|thalidomide|oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
12076383|NCT00019747|Procedure|adjuvant therapy|Initial dose: 100 mg by mouth (po) every bedtime ( Q hs) for four weeks, then progress to 200 mg po Q hs for four weeks, then progress to maintenance dose: 300 mg po Q hs.
12076384|NCT00019747|Other|Placebo|oral placebo once daily
12076385|NCT00019708|Drug|tanespimycin|Given IV
12076386|NCT00019682|Biological|Aldesleukin|Given IV
12076387|NCT00019682|Biological|gp100 Antigen|Given SC
12076388|NCT00019682|Drug|Montanide ISA 51 VG|Given SC
12076389|NCT00019682|Other|Quality-of-Life Assessment|Ancillary studies
12076390|NCT00019682|Other|Questionnaire Administration|Ancillary studies
12076391|NCT00019682|Other|Laboratory Biomarker Analysis|Correlative studies
12076392|NCT00019669|Biological|aldesleukin|
12076393|NCT00019669|Biological|fowlpox virus vaccine vector|
12076394|NCT00019669|Biological|gp100 antigen|
12076395|NCT00019656|Drug|perifosine|
12076396|NCT00019604|Procedure|computed tomography|Scan to assess the effects of ablation.
12076397|NCT00019604|Procedure|magnetic resonance imaging|Imaging used to assess the effects of this ablative therapy on tumor vascular density.
12076398|NCT00019604|Procedure|positron emission tomography|Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.
12076399|NCT00019604|Procedure|radiofrequency ablation|Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.
12076400|NCT00019604|Procedure|radionuclide imaging|Imaging following injection of a radioactive material.
12076401|NCT00019604|Procedure|ultrasound imaging|An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.
12076402|NCT00019604|Radiation|fludeoxyglucose F 18 (FDG-PET)|FDG PET scans rely on metabolic changes to evaluate response to therapy.
12076403|NCT00019604|Radiation|gadopentetate dimeglumine|Food and Drug Administration approved contrast agent.
12076404|NCT00019591|Biological|aldesleukin|
12076405|NCT00019591|Biological|ras peptide cancer vaccine|
12076406|NCT00019591|Procedure|adjuvant therapy|
12076407|NCT00019565|Procedure|magnetic resonance imaging|
12076408|NCT00019565|Procedure|positron emission tomography|
12076409|NCT00019565|Radiation|fludeoxyglucose F 18|
12076410|NCT00019513|Drug|fluorouracil|
12076411|NCT00019513|Drug|gemcitabine hydrochloride|
12076412|NCT00019513|Drug|leucovorin calcium|
12076413|NCT00019487|Biological|aldesleukin|
12076414|NCT00019487|Biological|gp209-2M antigen|
12076415|NCT00019487|Biological|incomplete Freund's adjuvant|
12076416|NCT00019461|Drug|carboxyamidotriazole|
12076417|NCT00019461|Drug|chemotherapy|
12076418|NCT00019422|Drug|carboplatin|
12076419|NCT00019422|Drug|lobradimil|
12076420|NCT00019331|Biological|aldesleukin|
12076421|NCT00019331|Biological|ras peptide cancer vaccine|
12076422|NCT00019331|Biological|sargramostim|
12076423|NCT00019331|Drug|DetoxPC|
12076424|NCT00019227|Drug|pentetic acid calcium|
12076425|NCT00019227|Radiation|yttrium Y 90 daclizumab|
12076426|NCT00019214|Biological|MART-1 antigen|
12076427|NCT00019214|Biological|aldesleukin|
12076428|NCT00019214|Biological|gp100 antigen|
12076429|NCT00019201|Other|cytology specimen collection procedure|
12076430|NCT00019201|Other|immunohistochemistry staining method|
12076431|NCT00019201|Other|sputum cytology|
12076432|NCT00019201|Procedure|bronchoscopic and lung imaging studies|
12076433|NCT00019201|Procedure|bronchoscopy|
12076434|NCT00019201|Procedure|comparison of screening methods|
12076435|NCT00019201|Procedure|endoscopic biopsy|
12076436|NCT00019136|Biological|MOv-gamma chimeric receptor gene|
12076437|NCT00019136|Biological|aldesleukin|
12076438|NCT00019136|Biological|therapeutic allogeneic lymphocytes|
12076439|NCT00019110|Biological|human papillomavirus 16 E7 peptide|
12076440|NCT00019110|Biological|synthetic human papillomavirus 16 E6 peptide|
12076441|NCT00019032|Biological|monoclonal antibody Mik-beta-1|
12076442|NCT00019019|Drug|carboxyamidotriazole|
12076443|NCT00019019|Drug|paclitaxel|
12076444|NCT00018967|Drug|glucarpidase|
12076445|NCT00017602|Biological|oblimersen sodium|
12076446|NCT00017602|Drug|dexamethasone|
12076447|NCT00017589|Biological|oblimersen sodium|
12076448|NCT00017589|Drug|gemtuzumab ozogamicin|
12076449|NCT00017563|Drug|docetaxel|35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
12076450|NCT00017563|Drug|mitoxantrone hydrochloride|Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
12076451|NCT00017563|Procedure|conventional surgery|Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
12076452|NCT00017550|Biological|anti-thymocyte globulin|
12076453|NCT00017524|Drug|pelitrexol|
12076454|NCT00017511|Drug|cevimeline hydrochloride|
12076455|NCT00017498|Drug|gemcitabine hydrochloride|
12076456|NCT00017485|Drug|HPPH|
12076457|NCT00017472|Biological|apolizumab|Given IV
12076458|NCT00017472|Other|laboratory biomarker analysis|Correlative studies
12076459|NCT00017472|Other|pharmacological study|Correlative studies
12076460|NCT00017381|Biological|rituximab|Given IV
12076461|NCT00017381|Drug|cyclophosphamide|Given IV
12076462|NCT00017381|Biological|filgrastim|Given SC
12076463|NCT00017381|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
12076464|NCT00017381|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
12076465|NCT00017355|Biological|filgrastim|
12076466|NCT00017355|Biological|therapeutic autologous dendritic cells|
12076467|NCT00017329|Drug|bortezomib|
12076468|NCT00017290|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
12076469|NCT00017290|Biological|keyhole limpet hemocyanin|
12076470|NCT00017290|Biological|sargramostim|
12076471|NCT00017290|Drug|cyclophosphamide|
12076472|NCT00017290|Drug|prednisone|
12076473|NCT00017290|Drug|vincristine sulfate|
12076474|NCT00017277|Biological|epoetin alfa|
12076475|NCT00017277|Radiation|radiation therapy|
12076476|NCT00017264|Drug|atrasentan hydrochloride|
12076477|NCT00017251|Biological|oblimersen sodium|Given IV
12076478|NCT00017251|Drug|carboplatin|Given IV
12076479|NCT00017251|Drug|etoposide|Given IV
12076480|NCT00017251|Other|pharmacological study|Correlative studies
12076481|NCT00017251|Other|laboratory biomarker analysis|Correlative studies
12076482|NCT00017238|Drug|KRN5500|Given IV
12076483|NCT00017238|Other|pharmacological study|Correlative studies
12076484|NCT00017225|Biological|filgrastim|
12076485|NCT00017225|Drug|carboplatin|
12076486|NCT00017225|Drug|cisplatin|
12076487|NCT00017225|Drug|cyclophosphamide|
12076488|NCT00017225|Drug|dacarbazine|
12076489|NCT00017225|Drug|doxorubicin hydrochloride|
12076490|NCT00017225|Drug|etoposide|
12076491|NCT00017225|Drug|ifosfamide|
12076492|NCT00017225|Drug|melphalan|
12076493|NCT00017225|Drug|tretinoin|
12076494|NCT00017225|Drug|vincristine sulfate|
12076495|NCT00017225|Drug|vindesine|
12076496|NCT00017225|Procedure|autologous bone marrow transplantation|
12076497|NCT00017225|Procedure|conventional surgery|
12076498|NCT00017225|Procedure|peripheral blood stem cell transplantation|
12076499|NCT00017225|Radiation|radiation therapy|
12076500|NCT00017212|Drug|exatecan mesylate|
12076501|NCT00017186|Drug|epirubicin hydrochloride|
12076502|NCT00017186|Drug|gemcitabine hydrochloride|
12076503|NCT00017173|Biological|Ad5CMV-p53 gene|2 intraoperative and one post-operative injection of Ad5CMV-p53.
12076504|NCT00017173|Drug|cisplatin|100 mg/m2 IV Day 1 every 21 days for 3 cycles
12076505|NCT00017173|Procedure|conventional surgery|conventional surgery
12076506|NCT00017173|Radiation|radiation therapy|200 cGy per day Days 105 every week for 6 weeks
12076507|NCT00017160|Drug|doxorubicin|
12076508|NCT00017160|Drug|filgrastim|
12076509|NCT00017160|Drug|ifosfamide|
12076510|NCT00017160|Procedure|biological response modifier therapy|
12076511|NCT00017160|Procedure|brachytherapy|
12076512|NCT00017160|Procedure|chemotherapy|
12076513|NCT00017160|Procedure|colony-stimulating factor therapy|
12076514|NCT00017160|Procedure|conventional surgery|
12076515|NCT00017160|Procedure|cytokine therapy|
12076516|NCT00017160|Procedure|intraoperative radiotherapy|
12076517|NCT00017160|Procedure|radiation therapy|
12076518|NCT00017160|Procedure|surgery|
12076519|NCT00017147|Drug|carmustine|"40 mg/m^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG.
~200 mg/m^2 IV over 1 hour on day 2 of each cycle for the active comparator arm."
12076520|NCT00017147|Radiation|radiation therapy|5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
12076521|NCT00017147|Drug|O6-Benzylguanine|120 mg/m^2 IV over 1 hour on day 1 of each cycle
12076522|NCT00017121|Biological|sargramostim|
12076523|NCT00017108|Drug|chlorambucil|
12076524|NCT00017108|Drug|cyclophosphamide|
12076525|NCT00017108|Drug|fludarabine phosphate|
12076526|NCT00017095|Biological|filgrastim|
12076527|NCT00017095|Drug|cyclophosphamide|
12076528|NCT00017095|Drug|docetaxel|
12076529|NCT00017095|Drug|epirubicin hydrochloride|
12076530|NCT00017095|Drug|fluorouracil|
12076531|NCT00017095|Genetic|microarray analysis|
12076532|NCT00017095|Other|immunohistochemistry staining method|
12076533|NCT00017095|Other|laboratory biomarker analysis|
12076534|NCT00017095|Procedure|biopsy|
12076535|NCT00017095|Procedure|conventional surgery|
12076536|NCT00017095|Procedure|neoadjuvant therapy|
12076537|NCT00017095|Radiation|radiation therapy|
12076538|NCT00017069|Drug|arsenic trioxide|
12076539|NCT00017069|Drug|dexamethasone|
12076540|NCT00017004|Radiation|External Beam Radiation Therapy|Undergo radiation
12076541|NCT00017004|Drug|Cisplatin|Given IV
12076542|NCT00017004|Radiation|Internal Radiation Therapy|Undergo radiation
12076543|NCT00017004|Biological|Epoetin Alfa|Given SC
12076544|NCT00016991|Drug|gefitinib|
12076545|NCT00016965|Drug|ixabepilone|
12076546|NCT00016952|Drug|fluorouracil|
12076547|NCT00016952|Drug|irinotecan hydrochloride|
12076548|NCT00016952|Drug|leucovorin calcium|
12076549|NCT00016926|Drug|capecitabine|
12076550|NCT00016913|Drug|carboplatin|AUC=6 week one of each 4 week cycle
12076551|NCT00016913|Drug|estramustine|2 tablets tid PO 5 of 7 days per week each 4 week cycle
12076552|NCT00016913|Drug|paclitaxel|80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle
12076553|NCT00016913|Radiation|radiation therapy|77.4 Gy in 1.8 Gy fractions
12076554|NCT00016913|Drug|leuprolide or goserelin acetate|7.5 mg IM injection once every 4 weeks for 6 months
12076555|NCT00016887|Biological|filgrastim|
12076556|NCT00016887|Biological|recombinant interferon alfa|
12076557|NCT00016887|Drug|carmustine|
12076558|NCT00016887|Drug|cyclophosphamide|
12076559|NCT00016887|Drug|cytarabine|
12076560|NCT00016887|Drug|dexamethasone|
12076561|NCT00016887|Drug|etoposide|
12076562|NCT00016887|Drug|melphalan|
12076563|NCT00016887|Procedure|bone marrow ablation with stem cell support|
12076564|NCT00016887|Procedure|peripheral blood stem cell transplantation|
12076565|NCT00016887|Radiation|radiation therapy|
12076566|NCT00016861|Drug|irinotecan hydrochloride|
12076567|NCT00016432|Drug|exemestane|25 mg for 5 years
12076568|NCT00016432|Drug|Placebo|Placebo
12076569|NCT00016419|Biological|anti-thymocyte globulin|3.5 mg/kg/d IV over 12 hrs day 1
12076570|NCT00016419|Drug|cyclosporine|3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
12076571|NCT00016406|Biological|filgrastim|
12076572|NCT00016406|Drug|cyclophosphamide|
12076573|NCT00016406|Drug|doxorubicin|
12076574|NCT00016406|Drug|paclitaxel|
12076575|NCT00016406|Procedure|surgery|
12076576|NCT00016393|Drug|ixabepilone|
12076577|NCT00016380|Drug|dexamethasone|
12076578|NCT00016380|Drug|ondansetron|
12076579|NCT00016380|Procedure|quality-of-life assessment|
12076580|NCT00016354|Drug|benzoylphenylurea|
12076581|NCT00016328|Drug|temsirolimus|Given IV
12076582|NCT00016328|Other|laboratory biomarker analysis|Correlative studies
12076583|NCT00016328|Other|pharmacological study|Correlative studies
12076584|NCT00016302|Drug|prednisone|Given orally
12076585|NCT00016302|Drug|vincristine sulfate|Given IV
12076586|NCT00016302|Drug|daunorubicin hydrochloride|Given IV
12076587|NCT00016302|Drug|asparaginase|Given IM
12076588|NCT00016302|Drug|methotrexate|Given IT and orally
12076589|NCT00016302|Drug|cyclophosphamide|Given IV
12076590|NCT00016302|Drug|cytarabine|Given IV or SC
12076591|NCT00016302|Drug|mercaptopurine|Given orally
12076592|NCT00016302|Drug|leucovorin calcium|Given IV or orally
12076593|NCT00016302|Drug|dexamethasone|Given orally
12076594|NCT00016302|Drug|doxorubicin hydrochloride|Given IV
12076595|NCT00016302|Drug|thioguanine|Given orally
12076596|NCT00016302|Radiation|radiation therapy|Undergo cranial irradiation
12076597|NCT00016302|Drug|nelarabine|Given IV
12076598|NCT00016302|Drug|pegaspargase|Given IM
12076599|NCT00016302|Radiation|radiation therapy|Undergo craniocervical radiotherapy
12076600|NCT00016302|Other|pharmacological study|Correlative studies
12076601|NCT00016302|Other|laboratory biomarker analysis|Correlative studies
12076602|NCT00016289|Biological|recombinant interleukin-12|Given intraperitoneally
12076603|NCT00016263|Biological|oblimersen sodium|
12076604|NCT00016263|Drug|dacarbazine|
12076605|NCT00016224|Drug|thalidomide|
12076606|NCT00016211|Radiation|radiation therapy|
12076607|NCT00016185|Drug|alvocidib|
12076608|NCT00016185|Drug|docetaxel|
12076609|NCT00016159|Biological|filgrastim|
12076610|NCT00016159|Biological|lintuzumab|
12076611|NCT00016159|Drug|arsenic trioxide|
12076612|NCT00016159|Drug|idarubicin|
12076613|NCT00016159|Drug|tretinoin|
12076614|NCT00016146|Biological|GPI-0100|
12076615|NCT00016146|Biological|MUC-2-Globo H-KLH conjugate vaccine|
12076616|NCT00016133|Biological|BCG vaccine|
12076617|NCT00016133|Biological|autologous tumor cell vaccine|
12076618|NCT00016133|Drug|fluorouracil|
12076619|NCT00016133|Drug|leucovorin calcium|
12076620|NCT00016133|Procedure|adjuvant therapy|
12076621|NCT00016094|Biological|bevacizumab|Given IV
12076622|NCT00016094|Other|laboratory biomarker analysis|Correlative studies
12076623|NCT00016081|Drug|ribavirin|
12076624|NCT00016068|Drug|ganciclovir|
12076625|NCT00016068|Drug|valganciclovir|
12076626|NCT00016055|Biological|lymphokine-activated killer cells|
12076627|NCT00016055|Drug|temozolomide|
12076628|NCT00016029|Other|screening questionnaire administration|
12076629|NCT00016029|Procedure|barium enema injection|
12076630|NCT00016029|Procedure|computed tomography|
12076631|NCT00016029|Procedure|computed tomography colonography|
12076632|NCT00016029|Procedure|diagnostic colonoscopy|
12076633|NCT00016029|Procedure|screening colonoscopy|
12076634|NCT00016016|Drug|cytarabine|Given IV
12076635|NCT00016016|Drug|mitoxantrone hydrochloride|Given IV
12076636|NCT00016016|Drug|alvocidib|Given IV
12076637|NCT00016016|Other|pharmacological study|Correlative studies
12076638|NCT00016016|Other|laboratory procedure|Correlative studies
12076639|NCT00015977|Biological|PSA prostate cancer vaccine|
12076640|NCT00015977|Biological|recombinant interleukin-12|
12076641|NCT00015951|Biological|bevacizumab|
12076642|NCT00015951|Drug|cytarabine|
12076643|NCT00015951|Drug|mitoxantrone hydrochloride|
12076644|NCT00015938|Biological|filgrastim|
12076645|NCT00015938|Drug|docetaxel|
12076646|NCT00015938|Drug|vinorelbine|
12076647|NCT00015925|Drug|entinostat|
12076648|NCT00015899|Drug|lonafarnib|
12076649|NCT00015873|Drug|asparaginase|
12076650|NCT00015873|Drug|cytarabine|
12076651|NCT00015873|Drug|mercaptopurine|
12076652|NCT00015873|Drug|methotrexate|
12076653|NCT00015873|Drug|prednisolone|
12076654|NCT00015873|Drug|vincristine sulfate|
12076655|NCT00015860|Drug|daunorubicin hydrochloride|
12076656|NCT00015860|Drug|imatinib mesylate|
12076657|NCT00015860|Drug|prednisone|
12076658|NCT00015860|Drug|vincristine sulfate|
12076659|NCT00015847|Biological|recombinant interferon alfa|IFN-α will be given at a dose ranging up to 5 MIU daily via subcutaneous injection.
12076660|NCT00015847|Drug|imatinib mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
12076661|NCT00015834|Drug|imatinib mesylate|Given PO
12076662|NCT00015834|Drug|cytarabine|Given IV
12076663|NCT00014612|Procedure|axillary lymph node dissection|
12076664|NCT00014612|Procedure|lymphoscintigraphy|
12076665|NCT00014612|Procedure|therapeutic conventional surgery|
12076666|NCT00014612|Radiation|radiation therapy|
12076667|NCT00014599|Drug|paclitaxel|
12076668|NCT00014586|Drug|bicalutamide|
12076669|NCT00014586|Drug|goserelin acetate|
12076670|NCT00014586|Procedure|orchiectomy|
12076671|NCT00014521|Drug|karenitecin|
12076672|NCT00014508|Biological|sargramostim|
12076673|NCT00014508|Drug|cyclophosphamide|
12076674|NCT00014508|Drug|cyclosporine|
12076675|NCT00014508|Drug|fludarabine phosphate|
12076676|NCT00014508|Drug|melphalan|
12076677|NCT00014508|Procedure|peripheral blood stem cell transplantation|
12076678|NCT00014495|Biological|filgrastim|
12076679|NCT00014495|Drug|cytarabine|
12076680|NCT00014495|Radiation|bismuth Bi213 monoclonal antibody M195|
12076681|NCT00014482|Procedure|pain therapy|
12076682|NCT00014482|Procedure|psychosocial assessment and care|
12076683|NCT00014469|Drug|busulfan|
12076684|NCT00014469|Drug|melphalan|
12076685|NCT00014469|Drug|methotrexate|
12076686|NCT00014469|Drug|tacrolimus|
12076687|NCT00014469|Procedure|allogeneic bone marrow transplantation|
12076688|NCT00014456|Biological|filgrastim|
12076689|NCT00014456|Drug|docetaxel|
12076690|NCT00014456|Drug|gemcitabine hydrochloride|
12076691|NCT00014443|Drug|thalidomide|
12076692|NCT00014443|Drug|topotecan hydrochloride|
12076693|NCT00014378|Drug|Chinese Herb Huanglian (Coptis chinesis)|Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).
12076694|NCT00014326|Radiation|radiation therapy|
12076695|NCT00014313|Drug|cisplatin|
12076696|NCT00014313|Drug|etoposide|
12076697|NCT00014274|Drug|carboplatin|
12076698|NCT00014274|Drug|gemcitabine hydrochloride|
12076699|NCT00014274|Drug|methotrexate|
12076700|NCT00014274|Drug|vinblastine sulfate|
12076701|NCT00014235|Drug|fludarabine phosphate|Given IV
12076702|NCT00014235|Radiation|total-body irradiation|Undergo TBI
12076703|NCT00014235|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
12076704|NCT00014235|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo PBSCT
12076705|NCT00014235|Drug|cyclosporine|Given PO or IV
12076706|NCT00014235|Drug|mycophenolate mofetil|Given IV or PO
12076707|NCT00014235|Other|laboratory biomarker analysis|Correlative studies
12076708|NCT00014222|Biological|epoetin alfa|40,000 IU
12076709|NCT00014222|Biological|filgrastim|5 mg/kg/d - days 2-13
12076710|NCT00014222|Drug|cyclophosphamide|75, 600 and 830 mg/m2
12076711|NCT00014222|Drug|doxorubicin hydrochloride|60 mg/m2
12076712|NCT00014222|Drug|epirubicin hydrochloride|60 mg/m2
12076713|NCT00014222|Drug|fluorouracil|500mg/m2
12076714|NCT00014222|Drug|paclitaxel|175 mg/m2
12076715|NCT00014196|Drug|cisplatin|
12076716|NCT00014196|Drug|docetaxel|
12076717|NCT00014196|Radiation|radiation therapy|
12076893|NCT00008307|Drug|mycophenolate mofetil|
12076718|NCT00014131|Biological|Biological/Vaccine: therapeutic autologous dendritic cells.|Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
12076719|NCT00014118|Drug|carboplatin|
12076720|NCT00014118|Drug|paclitaxel|
12076721|NCT00014118|Procedure|conventional surgery|
12076722|NCT00014118|Radiation|radiation therapy|
12076723|NCT00014092|Biological|aldesleukin|
12076724|NCT00014092|Biological|recombinant interferon alfa|
12076725|NCT00014092|Biological|sargramostim|
12076726|NCT00014092|Drug|temozolomide|
12076727|NCT00014079|Genetic|DNA stability analysis|
12076728|NCT00014079|Genetic|loss of heterozygosity analysis|
12076729|NCT00014079|Genetic|microsatellite instability analysis|
12076730|NCT00012389|Drug|irinotecan hydrochloride|
12076731|NCT00012389|Drug|oxaliplatin|
12076732|NCT00012376|Drug|bryostatin 1|Given IV
12076733|NCT00012376|Biological|sargramostim|Given subcutaneously
12076734|NCT00012376|Other|laboratory biomarker analysis|Correlative studies
12076735|NCT00012376|Other|pharmacological study|Correlative studies
12076736|NCT00012363|Drug|gemcitabine hydrochloride|1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days
12076737|NCT00012363|Drug|irinotecan hydrochloride|100 mg/m2, IV over 90 min, days 1 & 8, q 21days
12076738|NCT00012324|Drug|doxorubicin hydrochloride|
12076739|NCT00012324|Drug|nolatrexed dihydrochloride|
12076740|NCT00012298|Biological|rituximab|Given IV
12076741|NCT00012298|Biological|yttrium Y 90 ibritumomab tiuxetan|Given IV
12076742|NCT00012298|Biological|indium In 111 ibritumomab tiuxetan|Given IV
12076743|NCT00012298|Biological|oprelvekin|Given subcutaneously
12076744|NCT00012298|Biological|filgrastim|Given subcutaneously
12076745|NCT00012246|Biological|carcinoembryonic antigen peptide 1-6D|
12076746|NCT00012246|Biological|incomplete Freund's adjuvant|
12076747|NCT00012246|Biological|sargramostim|
12076748|NCT00012220|Drug|cisplatin|50 mg/sq m IV infusion over 30 min on Days 1 & 15 of ea cycle
12076749|NCT00012220|Drug|docetaxel|40 mg/sq m IV infusion over 60 min on Days 1 & 8 of ea treatment cycle
12076750|NCT00012220|Drug|gemcitabine hydrochloride|"Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, & 15 of ea cycle
~cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle
~docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 & 8 of ea cycle"
12076751|NCT00012220|Drug|irinotecan hydrochloride|100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 & 8 of ea cycle
12076752|NCT00012207|Biological|aldesleukin|
12076753|NCT00012207|Biological|therapeutic autologous lymphocytes|
12076754|NCT00012207|Drug|cyclophosphamide|
12076755|NCT00012207|Drug|prednisone|
12076756|NCT00012207|Drug|vincristine sulfate|
12076757|NCT00012207|Procedure|adjuvant therapy|
12076758|NCT00012194|Drug|7-hydroxystaurosporine|Given IV
12076759|NCT00012194|Drug|cisplatin|Given IV
12076760|NCT00012194|Other|laboratory biomarker analysis|Correlative studies
12076761|NCT00012181|Drug|alvocidib|Given IV
12076762|NCT00012181|Other|pharmacological study|Correlative studies
12076763|NCT00012168|Drug|isosulfan blue|
12076764|NCT00012168|Genetic|polymerase chain reaction|
12076765|NCT00012168|Other|immunohistochemistry staining method|
12076766|NCT00012168|Procedure|lymphangiography|
12076767|NCT00012168|Procedure|radionuclide imaging|
12076768|NCT00012168|Procedure|sentinel lymph node biopsy|
12076769|NCT00012168|Radiation|technetium Tc 99m sulfur colloid|
12076770|NCT00012103|Other|bronchoalveolar lavage|
12076771|NCT00012103|Other|screening questionnaire administration|
12076772|NCT00012103|Other|sputum cytology|
12076773|NCT00012103|Procedure|bronchoscopic and lung imaging studies|
12076774|NCT00012103|Procedure|bronchoscopy|
12076775|NCT00012103|Procedure|computed tomography|
12076776|NCT00012103|Procedure|study of high risk factors|
12076777|NCT00012064|Biological|therapeutic autologous dendritic cells|Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
12076778|NCT00012051|Biological|filgrastim|
12076779|NCT00012051|Biological|rituximab|
12076780|NCT00012051|Drug|carmustine|
12076781|NCT00012051|Drug|cisplatin|
12076782|NCT00012051|Drug|cytarabine|
12076783|NCT00012051|Drug|dexamethasone|
12076784|NCT00012051|Drug|etoposide|
12076785|NCT00012051|Drug|ifosfamide|
12076786|NCT00012051|Drug|melphalan|
12076787|NCT00012051|Drug|methotrexate|
12076788|NCT00012051|Procedure|bone marrow ablation with stem cell support|
12076789|NCT00012051|Procedure|peripheral blood stem cell transplantation|
12076790|NCT00012051|Radiation|radiation therapy|
12076791|NCT00012038|Drug|irofulven|
12076792|NCT00012025|Drug|fulvestrant|
12076793|NCT00012012|Drug|Amifostine trihydrate|Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections.
12076794|NCT00012012|Drug|Cisplatin|Cisplatin will be given weekly with external beam radiation therapy and once with brachytherapy for a total of six doses. Patients receive 40 mg/m^2 by IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.
12076795|NCT00012012|Radiation|Intracavitary brachytherapy|For low dose rate (LDR) brachytherapy, cesium will be given in one to two intracavitary applications, within two weeks of completion of external radiation. The interval between the two applications will be one to three weeks. It is recommended that the total course of treatment be completed in less than eight weeks. High dose rate (HDR) brachytherapy may start as early as week two of external radiation. The minimum cumulative external and intracavitary dose should be 85 Gy.
12076894|NCT00008307|Procedure|allogeneic bone marrow transplantation|
12076796|NCT00012012|Radiation|External beam radiation therapy|Patients will receive 1.8 Gy daily for five weeks for a total dose of 45 Gy; involved lateral parametrium and/or pelvic nodes should be boosted for a total dose (including intracavitary treatment) of 60 Gy ± 5%.
12076797|NCT00011999|Drug|cisplatin|
12076798|NCT00011999|Drug|paclitaxel|
12076799|NCT00011999|Procedure|conventional surgery|
12076800|NCT00011999|Radiation|radiation therapy|
12076801|NCT00011986|Drug|Paclitaxel|Given IV
12076802|NCT00011986|Drug|Carboplatin|Given IV
12076803|NCT00011986|Drug|Gemcitabine Hydrochloride|Given IV
12076804|NCT00011986|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|
12076805|NCT00011986|Drug|Topotecan Hydrochloride|Given IV
12076806|NCT00011986|Procedure|Therapeutic Conventional Surgery|Undergo surgery
12076807|NCT00011960|Drug|cisplatin|
12076808|NCT00011960|Drug|paclitaxel|
12076809|NCT00011960|Procedure|adjuvant therapy|
12076810|NCT00011960|Radiation|radiation therapy|
12076811|NCT00011921|Biological|filgrastim|
12076812|NCT00011921|Drug|carboplatin|
12076813|NCT00011921|Drug|epirubicin hydrochloride|
12076814|NCT00011921|Drug|etoposide|
12076815|NCT00011921|Drug|etoposide phosphate|
12076816|NCT00011921|Drug|ifosfamide|
12076817|NCT00011921|Drug|paclitaxel|
12076818|NCT00011921|Procedure|autologous bone marrow transplantation|
12076819|NCT00011921|Procedure|bone marrow ablation with stem cell support|
12076820|NCT00011921|Procedure|peripheral blood stem cell transplantation|
12076821|NCT00011921|Radiation|radiation therapy|
12076822|NCT00010270|Biological|LMB-9 immunotoxin|
12076823|NCT00010257|Drug|carboplatin|Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles
12076824|NCT00010257|Drug|paclitaxel|225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
12076825|NCT00010218|Drug|karenitecin|
12076826|NCT00010205|Drug|benzoylphenylurea|Given orally
12076827|NCT00010205|Other|pharmacological study|Correlative studies
12076828|NCT00010192|Biological|rituximab|Given IV
12076829|NCT00010192|Biological|aldesleukin|Given SC
12076830|NCT00010192|Other|laboratory biomarker analysis|Correlative studies
12076831|NCT00010192|Other|pharmacological study|Correlative studies
12076832|NCT00010166|Drug|gemcitabine hydrochloride|
12076833|NCT00010166|Procedure|adjuvant therapy|
12076834|NCT00010166|Radiation|radiation therapy|
12076835|NCT00010153|Drug|fulvestrant|
12076836|NCT00010153|Procedure|conventional surgery|
12076837|NCT00010140|Drug|docetaxel|
12076838|NCT00010140|Drug|epirubicin hydrochloride|
12076839|NCT00010140|Drug|tamoxifen citrate|
12076840|NCT00010140|Procedure|adjuvant therapy|
12076841|NCT00010075|Drug|fluorouracil|
12076842|NCT00010075|Drug|leucovorin calcium|
12076843|NCT00010075|Drug|mitoxantrone hydrochloride|
12076844|NCT00010062|Drug|fluorouracil|
12076845|NCT00010062|Radiation|radiation therapy|
12076846|NCT00010049|Drug|imatinib mesylate|
12076847|NCT00010023|Drug|capecitabine|
12076848|NCT00010023|Drug|cisplatin|
12076849|NCT00009984|Drug|fludarabine phosphate|Given IV
12076850|NCT00009984|Drug|thalidomide|Given orally
12076851|NCT00009971|Drug|fenretinide|
12076852|NCT00009945|Drug|clodronate|1600 mg PO daily
12076853|NCT00009945|Drug|placebo|2 pills PO daily
12076854|NCT00009880|Biological|filgrastim|
12076855|NCT00009880|Drug|cisplatin|
12076856|NCT00009880|Drug|fluorouracil|
12076857|NCT00009880|Drug|paclitaxel|
12076858|NCT00009880|Radiation|radiation therapy|
12076859|NCT00009854|Drug|carmustine in ethanol|
12076860|NCT00009854|Procedure|conventional surgery|
12076861|NCT00009776|Biological|monoclonal antibody Lym-1|
12076862|NCT00009776|Drug|cyclosporine|
12076863|NCT00009776|Drug|paclitaxel|
12076864|NCT00009776|Radiation|indium In 111 monoclonal antibody Lym-1|
12076865|NCT00009776|Radiation|yttrium Y 90 monoclonal antibody Lym-1|
12076866|NCT00009763|Biological|filgrastim|
12076867|NCT00009763|Biological|monoclonal antibody m170|
12076868|NCT00009763|Drug|cyclosporine|
12076869|NCT00009763|Drug|paclitaxel|
12076870|NCT00009763|Procedure|peripheral blood stem cell transplantation|
12076871|NCT00009763|Radiation|yttrium Y 90 monoclonal antibody m170|
12076872|NCT00009750|Biological|filgrastim|
12076873|NCT00009750|Biological|monoclonal antibody m170|
12076874|NCT00009750|Drug|cyclosporine|
12076875|NCT00009750|Drug|paclitaxel|
12076876|NCT00009750|Procedure|peripheral blood stem cell transplantation|
12076877|NCT00009750|Radiation|indium In 111 monoclonal antibody m170|
12076878|NCT00009750|Radiation|yttrium Y 90 monoclonal antibody m170|
12076879|NCT00009711|Procedure|management of therapy complications|
12076880|NCT00008697|Drug|arsenic trioxide|
12076881|NCT00008437|Device|high-intensity focused ultrasound ablation|
12076882|NCT00008411|Drug|Docetaxel|Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.
12076883|NCT00008411|Drug|Docetaxel|35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.
12076884|NCT00008385|Other|placebo|Given orally
12076885|NCT00008385|Drug|selenium|Given orally
12076886|NCT00008346|Diagnostic Test|Full Field Digital Mammography|Radiologic test to screen women for Breast cancer using digital detectors
12076887|NCT00008346|Diagnostic Test|Screen Film Mammography|Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen
12076888|NCT00008307|Biological|anti-thymocyte globulin|
12076889|NCT00008307|Drug|cyclosporine|
12076890|NCT00008307|Drug|fludarabine phosphate|
12076891|NCT00008307|Drug|melphalan|
12076895|NCT00008307|Procedure|peripheral blood stem cell transplantation|
12076896|NCT00008307|Procedure|syngeneic bone marrow transplantation|
12076897|NCT00008294|Drug|FOLFOX regimen|
12076898|NCT00008294|Drug|dexamethasone|
12076899|NCT00008294|Drug|floxuridine|
12076900|NCT00008294|Drug|fluorouracil|
12076901|NCT00008294|Drug|leucovorin calcium|
12076902|NCT00008294|Drug|oxaliplatin|
12076903|NCT00008268|Biological|filgrastim|
12076904|NCT00008268|Drug|melphalan|
12076905|NCT00008216|Procedure|Peripheral Blood Stem Cell Transplantation|
12076906|NCT00008190|Biological|aldesleukin|
12076907|NCT00008190|Biological|filgrastim|
12076908|NCT00008190|Drug|busulfan|
12076909|NCT00008190|Drug|cyclophosphamide|
12076910|NCT00008190|Drug|etoposide|
12076911|NCT00008190|Drug|melphalan|
12076912|NCT00008190|Procedure|peripheral blood stem cell transplantation|
12076913|NCT00008164|Procedure|umbilical cord blood transplantation|
12076914|NCT00008138|Drug|carboplatin|pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles
12076915|NCT00008138|Drug|paclitaxel|pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles
12076916|NCT00008138|Procedure|debulking surgery|exploratory laparotomy, interval cytoreduction (to < 1 cm residual)
12076917|NCT00008060|Drug|FOLFIRI regimen|
12076918|NCT00008060|Drug|FOLFOX regimen|
12076919|NCT00008060|Drug|fluorouracil|
12076920|NCT00008060|Drug|irinotecan hydrochloride|
12076921|NCT00008060|Drug|leucovorin calcium|
12076922|NCT00008060|Drug|oxaliplatin|
12076923|NCT00008047|Drug|fluorouracil|
12076924|NCT00008047|Drug|hydroxyurea|
12076925|NCT00008047|Drug|paclitaxel|
12076926|NCT00008047|Procedure|conventional surgery|
12076927|NCT00008047|Radiation|radiation therapy|
12076928|NCT00008008|Biological|filgrastim|
12076929|NCT00008008|Biological|sargramostim|
12076930|NCT00008008|Drug|cyclophosphamide|
12076931|NCT00008008|Drug|thiotepa|
12076932|NCT00008008|Procedure|autologous bone marrow transplantation|
12076933|NCT00008008|Procedure|bone marrow ablation with stem cell support|
12076934|NCT00008008|Procedure|peripheral blood stem cell transplantation|
12076935|NCT00007995|Biological|filgrastim|
12076936|NCT00007995|Biological|recombinant interferon alfa|
12076937|NCT00007995|Biological|sargramostim|
12076938|NCT00007995|Drug|busulfan|
12076939|NCT00007995|Drug|cyclophosphamide|
12076940|NCT00007995|Drug|melphalan|
12076941|NCT00007995|Procedure|autologous bone marrow transplantation|
12076942|NCT00007995|Procedure|bone marrow ablation with stem cell support|
12076943|NCT00007995|Procedure|peripheral blood stem cell transplantation|
12076944|NCT00007982|Biological|filgrastim|
12076945|NCT00007982|Drug|carmustine|
12076946|NCT00007982|Drug|cisplatin|
12076947|NCT00007982|Drug|cyclophosphamide|
12076948|NCT00007982|Drug|etoposide|
12076949|NCT00007982|Drug|thiotepa|
12076950|NCT00007982|Procedure|adjuvant therapy|
12076951|NCT00007982|Procedure|autologous bone marrow transplantation|
12076952|NCT00007982|Procedure|bone marrow ablation with stem cell support|
12076953|NCT00007982|Procedure|peripheral blood stem cell transplantation|
12076954|NCT00007956|Biological|monoclonal antibody mono-dgA-RFB4|
12076955|NCT00007930|Procedure|conventional surgery|
12076956|NCT00007930|Procedure|laparoscopic surgery|
12076957|NCT00007904|Biological|filgrastim|Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC > 10,000/uL x1 day after the nadir cycles 1-3.
12076958|NCT00007904|Drug|cyclophosphamide|cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3
12076959|NCT00007904|Drug|doxorubicin hydrochloride|Patients then receive doxorubicin IV on day 1.
12076960|NCT00007904|Drug|paclitaxel|Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3
12076961|NCT00007904|Drug|tamoxifen citrate|tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed
12076962|NCT00007904|Procedure|adjuvant therapy|Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.
12076963|NCT00007904|Radiation|radiation therapy|Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.
12076964|NCT00007891|Biological|filgrastim|
12076965|NCT00007891|Procedure|autologous bone marrow transplantation|
12076966|NCT00007891|Procedure|peripheral blood stem cell transplantation|
12076967|NCT00007891|Radiation|indium In 111 monoclonal antibody BrE-3|
12076968|NCT00007891|Radiation|yttrium Y 90 monoclonal antibody BrE-3|
12076969|NCT00007865|Biological|rituximab|
12076970|NCT00007865|Drug|carboplatin|
12076971|NCT00007865|Drug|etoposide|
12076972|NCT00007865|Drug|ifosfamide|
12076973|NCT00007826|Biological|BCG vaccine|
12076974|NCT00007826|Biological|monoclonal antibody 105AD7 anti-idiotype vaccine|
12076975|NCT00007826|Drug|alum adjuvant|
12076976|NCT00006994|Dietary Supplement|glutamine|20 cc three times daily for 60 days
12076977|NCT00006994|Radiation|radiation therapy|Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
12076978|NCT00006994|Drug|l-glutamine placebo|20 cc three times daily for 60 days
12076979|NCT00006981|Biological|SS1(dsFv)-PE38 immunotoxin|
12076980|NCT00006942|Drug|bryostatin 1|Given IV
12076981|NCT00006942|Drug|cisplatin|Given IV
12076982|NCT00006942|Other|laboratory biomarker analysis|Correlative studies
12076983|NCT00006929|Drug|suramin|Given IV
12076984|NCT00006929|Drug|carboplatin|Given IV
12076985|NCT00006929|Drug|paclitaxel|Given IV
12076986|NCT00006929|Other|pharmacological study|Correlative studies
12076987|NCT00006929|Other|laboratory biomarker analysis|Correlative studies
12076988|NCT00006916|Biological|bleomycin|
12076989|NCT00006916|Device|Ommaya reservoir|
12076990|NCT00006916|Radiation|radiation therapy|60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.
12076991|NCT00006903|Drug|Fulvestrant|Given intramuscularly
12076992|NCT00006825|Biological|trastuzumab|
12076993|NCT00006825|Drug|pegylated liposomal doxorubicin hydrochloride|
12076994|NCT00006773|Drug|bortezomib|Given IV
12076995|NCT00006760|Biological|filgrastim|subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.
12076996|NCT00006760|Drug|ifosfamide|V over 24 hours on days 1-4
12076997|NCT00006760|Drug|vinorelbine tartrate|IV over 6-10 minutes on days 1 and 5.
12076998|NCT00006747|Drug|carmustine|IV
12076999|NCT00006747|Drug|melphalan|IV
12077000|NCT00006747|Drug|etoposide|IV
12077001|NCT00006747|Drug|cytarabine|IV
12077002|NCT00006747|Drug|tacrolimus|IV
12077003|NCT00006747|Drug|methotrexate|IV
12077004|NCT00006747|Drug|sargramostim|IV
12077005|NCT00006747|Procedure|transplant|
12077006|NCT00006734|Biological|filgrastim|Given IV
12077007|NCT00006734|Drug|cyclophosphamide|Given IV
12077008|NCT00006734|Drug|doxorubicin hydrochloride|Given IV
12077009|NCT00006734|Drug|etoposide|Given IV
12077010|NCT00006734|Drug|ifosfamide|Given IV
12077011|NCT00006734|Drug|vincristine sulfate|Given IV
12077012|NCT00006734|Procedure|adjuvant therapy|
12077013|NCT00006734|Procedure|conventional surgery|
12077014|NCT00006734|Procedure|neoadjuvant therapy|
12077015|NCT00006734|Radiation|brachytherapy|
12077016|NCT00006734|Radiation|radiation therapy|
12077017|NCT00006721|Biological|rituximab|Given IV
12077018|NCT00006721|Drug|cyclophosphamide|Given IV
12077019|NCT00006721|Drug|doxorubicin|Given IV
12077020|NCT00006721|Drug|prednisone|Given orally
12077021|NCT00006721|Drug|vincristine|Given IV
12077022|NCT00006721|Radiation|tositumomab|Given IV
12077023|NCT00006695|Drug|carmustine|300 mg/m2 IV on Day -6
12077024|NCT00006695|Drug|cytarabine|100 mg/m2 BID on Days -5 through -2
12077025|NCT00006695|Drug|etoposide|100 mg/m2 BID on Days -5 through -2
12077026|NCT00006695|Drug|melphalan|140 mg/m2 IV on Day -1
12077027|NCT00006695|Procedure|peripheral blood stem cell transplantation|Following the chemotherapy, on Day 0 of treatment, the previously stored hematopoietic stem cells will be administered to the patient intravenously through a central line to the patient.
12077028|NCT00006695|Radiation|tositumomab and iodine I 131 tositumomab|"Patients will receive two administrations of Iodine-131 Anti-B1 Antibody; the dosimetric dose and the therapeutic dose. The dosimetric dose will consist of an infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by an infusion of Anti-B1 Antibody (35 mg) which has been trace labeled with 5 mCi of Iodine-131 Anti-B1 Antibody. Using whole body anterior and posterior gamma camera scans and serial imaging studies over approximately one week, the clearance of the whole body dosimetric dose will be used to calculate the subsequent therapeutic dose of Iodine-131 Anti-B1 Antibody which delivers a total body dose of 75 cGy to the subject"
12077029|NCT00006656|Drug|carmustine in ethanol|
12077030|NCT00006656|Procedure|conventional surgery|
12077031|NCT00006485|Drug|alvocidib|
12077032|NCT00006485|Drug|irinotecan hydrochloride|
12077033|NCT00006479|Drug|FOLFOX regimen|
12077034|NCT00006479|Drug|fluorouracil|
12077035|NCT00006479|Drug|leucovorin calcium|
12077036|NCT00006479|Drug|oxaliplatin|
12077037|NCT00006479|Procedure|adjuvant therapy|
12077038|NCT00006479|Procedure|conventional surgery|
12077039|NCT00006479|Procedure|neoadjuvant therapy|
12077040|NCT00006478|Biological|autologous tumor cell vaccine|
12077041|NCT00006478|Biological|keyhole limpet hemocyanin|
12077042|NCT00006478|Biological|sargramostim|
12077043|NCT00006478|Procedure|adjuvant therapy|
12077044|NCT00006477|Dietary Supplement|mistletoe extract|
12077045|NCT00006476|Drug|suramin|
12077046|NCT00006476|Procedure|conventional surgery|
12077047|NCT00006474|Drug|O6-benzylguanine|
12077048|NCT00006474|Drug|temozolomide|
12077049|NCT00006474|Procedure|conventional surgery|
12077050|NCT00006473|Drug|oxaliplatin|Given IV
12077051|NCT00006471|Drug|Fenretinide|1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.
12077052|NCT00006470|Biological|monoclonal antibody 11D10 anti-idiotype vaccine|
12077053|NCT00006470|Biological|monoclonal antibody 3H1 anti-idiotype vaccine|
12077054|NCT00006470|Radiation|radiation therapy|
12077055|NCT00006469|Drug|carboplatin|
12077056|NCT00006469|Drug|paclitaxel|
12077057|NCT00006469|Procedure|conventional surgery|
12077058|NCT00006469|Procedure|neoadjuvant therapy|
12077059|NCT00006469|Radiation|radiation therapy|
12077060|NCT00006468|Drug|FOLFOX regimen|
12077061|NCT00006468|Drug|fluorouracil|
12077062|NCT00006468|Drug|leucovorin calcium|
12077063|NCT00006468|Drug|oxaliplatin|
12077064|NCT00006465|Drug|capecitabine|Patients receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).
12077571|NCT00005788|Biological|aldesleukin|
12077065|NCT00006465|Drug|irinotecan hydrochloride|Patients receive irinotecan IV over 30 minutes once weekly for 4 weeks (one hour after oxaliplatin). Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).
12077066|NCT00006465|Drug|oxaliplatin|Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
12077067|NCT00006462|Drug|gemcitabine hydrochloride|
12077068|NCT00006461|Drug|cisplatin|Given IV
12077069|NCT00006461|Drug|cyclophosphamide|Given IV
12077070|NCT00006461|Drug|vincristine sulfate|Given IV
12077071|NCT00006461|Drug|etoposide|Given PO
12077072|NCT00006461|Procedure|therapeutic conventional surgery|Undergo surgery
12077073|NCT00006461|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal radiation therapy
12077074|NCT00006456|Radiation|stereotactic radiosurgery|
12077075|NCT00006455|Drug|cyclophosphamide|
12077076|NCT00006455|Drug|cytarabine|
12077077|NCT00006455|Drug|dexamethasone|
12077078|NCT00006455|Drug|doxorubicin hydrochloride|
12077079|NCT00006455|Drug|etoposide|
12077080|NCT00006455|Drug|ifosfamide|
12077081|NCT00006455|Drug|leucovorin calcium|
12077082|NCT00006455|Drug|methotrexate|
12077083|NCT00006455|Drug|therapeutic hydrocortisone|
12077084|NCT00006455|Drug|vinblastine sulfate|
12077085|NCT00006392|Drug|Vitamin E|400 IU daily by mouth for 7-12 years
12077086|NCT00006392|Drug|Selenium|200 mcg daily for 7-12 years
12077087|NCT00006392|Other|Vitamin E placebo|daily for 7-12 years
12077088|NCT00006392|Other|selenium placebo|daily for 7-12 years
12077089|NCT00006391|Drug|oxaliplatin|
12077090|NCT00006391|Drug|topotecan hydrochloride|
12077091|NCT00006390|Biological|alemtuzumab|
12077092|NCT00006390|Biological|filgrastim|
12077093|NCT00006390|Drug|cyclophosphamide|
12077094|NCT00006390|Procedure|peripheral blood stem cell transplantation|
12077095|NCT00006390|Radiation|radiation therapy|
12077096|NCT00006389|Drug|bryostatin 1|Given IV
12077097|NCT00006389|Drug|cisplatin|Given IV
12077098|NCT00006389|Other|laboratory biomarker analysis|Correlative studies
12077099|NCT00006386|Drug|carmustine|
12077100|NCT00006386|Radiation|radiation therapy|
12077101|NCT00006386|Radiation|stereotactic radiosurgery|
12077102|NCT00006385|Biological|MART-1 antigen|
12077103|NCT00006385|Biological|gp100 antigen|
12077104|NCT00006385|Biological|incomplete Freund's adjuvant|
12077105|NCT00006385|Biological|recombinant interferon alfa|
12077106|NCT00006385|Biological|sargramostim|
12077107|NCT00006385|Biological|tyrosinase peptide|
12077108|NCT00006381|Biological|trastuzumab|
12077109|NCT00006381|Drug|celecoxib|
12077110|NCT00006379|Biological|anti-thymocyte globulin|anti-thymocyte globulin IV over at least 4 hours on days -2 and -1
12077111|NCT00006379|Biological|graft-versus-tumor induction therapy|Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
12077112|NCT00006379|Drug|cyclophosphamide|cyclophosphamide IV over 2 hours on days -3 to -2
12077113|NCT00006379|Drug|fludarabine phosphate|fludarabine IV over 30 minutes on days -8 to -4
12077114|NCT00006379|Procedure|peripheral blood stem cell transplantation|Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
12077115|NCT00006373|Drug|etoposide|Etoposide IV 500 mg/m2/day over 24 hours Days -5, -4, -3
12077116|NCT00006373|Drug|ifosfamide|Ifosfamide 3,333 mg/m2/day IV over 2 hours (total dose 10,000 mg/m2)Days -8, -7, -6
12077117|NCT00006373|Drug|topotecan hydrochloride|Topotecan 21.3 mg/m2/day (total dose 64 mg/m2 ) IV over 30 minutes Days -8, -7, -6
12077118|NCT00006373|Procedure|autologous bone marrow transplantation|
12077119|NCT00006373|Drug|Mesna|Mesna 1,111 mg/m2/dose IV over 30 minutes; 30 minutes before and 4 and 8 hours after ifosfamide (total dose 10,000 mg/m2) Days -8, -7, -6
12077120|NCT00006372|Drug|gemcitabine hydrochloride|Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
12077121|NCT00006372|Drug|pegylated liposomal doxorubicin hydrochloride|Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
12077122|NCT00006372|Drug|vinorelbine ditartrate|Patients receive vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
12077123|NCT00006366|Drug|fluorouracil|
12077124|NCT00006366|Drug|irinotecan hydrochloride|
12077125|NCT00006366|Procedure|conventional surgery|
12077126|NCT00006366|Radiation|radiation therapy|
12077127|NCT00006364|Drug|omacetaxine mepesuccinate|Given IV or SC
12077128|NCT00006364|Other|pharmacological study|Correlative studies
12077129|NCT00006364|Other|laboratory biomarker analysis|Correlative studies
12077130|NCT00006363|Drug|cytarabine|Given IV
12077131|NCT00006363|Drug|daunorubicin hydrochloride|Given IV
12077132|NCT00006363|Drug|etoposide|Given IV
12077133|NCT00006363|Drug|valspodar|Given IV
12077134|NCT00006363|Biological|filgrastim|Given SC
12077135|NCT00006363|Drug|busulfan|Given orally
12077136|NCT00006363|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous PBSCT
12077137|NCT00006363|Procedure|peripheral blood stem cell transplantation|Undergo autologous PBSCT
12077138|NCT00006363|Biological|aldesleukin|Given SC
12077139|NCT00006363|Other|clinical observation|Undergo clinical observation
12077140|NCT00006363|Other|pharmacological study|Correlative studies
12077141|NCT00006362|Drug|bortezomib|
12077142|NCT00006360|Drug|radioprotection|
12077143|NCT00006360|Radiation|radiation therapy|
12077144|NCT00006359|Drug|LHRH agonist|Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
12077145|NCT00006359|Drug|antiandrogen|flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
12077146|NCT00006359|Radiation|radiation therapy|4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
12077147|NCT00006359|Radiation|Brachytherapy boost|Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
12077148|NCT00006356|Drug|carboplatin|
12077149|NCT00006356|Drug|cisplatin|
12077150|NCT00006356|Procedure|conventional surgery|
12077151|NCT00006355|Drug|pyrazoloacridine|
12077152|NCT00006355|Procedure|adjuvant therapy|
12077153|NCT00006355|Radiation|radiation therapy|
12077154|NCT00006354|Dietary Supplement|mistletoe extract|
12077155|NCT00006351|Drug|gemcitabine hydrochloride|
12077156|NCT00006351|Drug|lonafarnib|
12077157|NCT00006347|Radiation|indium In 111 monoclonal antibody MN-14|
12077158|NCT00006347|Radiation|yttrium Y 90 monoclonal antibody MN-14|
12077159|NCT00006340|Drug|arginine butyrate|
12077160|NCT00006340|Drug|ganciclovir|
12077161|NCT00006268|Biological|cintredekin besudotox|
12077162|NCT00006268|Drug|isolated perfusion|
12077163|NCT00006268|Procedure|conventional surgery|
12077164|NCT00006267|Drug|rubitecan|
12077165|NCT00006264|Biological|aldesleukin|
12077166|NCT00006264|Drug|ganciclovir|
12077167|NCT00006264|Drug|zidovudine|
12077168|NCT00006263|Biological|filgrastim|
12077169|NCT00006263|Drug|carboplatin|
12077170|NCT00006263|Drug|temozolomide|
12077171|NCT00006260|Drug|cisplatin|cisplatin IV over 30 minutes on days 1-3.
12077172|NCT00006260|Drug|etoposide|etoposide IV over 60-90 minutes on days 1-3.
12077173|NCT00006260|Drug|ifosfamide|ifosfamide IV over 30 minutes on days 1-3.
12077174|NCT00006260|Drug|Mesna|Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.
12077175|NCT00006258|Biological|filgrastim|
12077176|NCT00006258|Drug|cisplatin|
12077177|NCT00006258|Drug|cyclophosphamide|
12077178|NCT00006258|Drug|etoposide|
12077179|NCT00006258|Drug|methotrexate|
12077180|NCT00006258|Drug|vincristine sulfate|
12077181|NCT00006258|Procedure|adjuvant therapy|
12077182|NCT00006258|Radiation|radiation therapy|
12077183|NCT00006256|Drug|paclitaxel|Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen.
12077184|NCT00006256|Procedure|adjuvant therapy|doxorubicin and cyclophosphamide adjuvant regimen
12077185|NCT00006256|Radiation|radiation therapy|Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.
12077186|NCT00006255|Procedure|radiofrequency ablation|Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
12077187|NCT00006255|Procedure|thermal ablation therapy|Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
12077188|NCT00006252|Drug|fludarabine phosphate|30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3)
12077189|NCT00006252|Drug|Cyclophosphamide|1 g/sq m/day IV infusion x 3 days (Days -5 thru -3)
12077190|NCT00006252|Biological|PBSC|2-8,000,000/kg CD34+ cells via infusion on Day 0
12077191|NCT00006252|Drug|G-CSF|5 ug/kg/day subQ injection until ANC > 1000/uL for 3 days beginning Day 5
12077192|NCT00006252|Biological|Donor lymphocytes|10,000,000 CD3+ cells/kg via infusion
12077193|NCT00006250|Drug|chlorambucil|
12077194|NCT00006250|Drug|dexamethasone|
12077195|NCT00006250|Drug|fludarabine phosphate|
12077196|NCT00006250|Drug|mitoxantrone hydrochloride|
12077197|NCT00006249|Biological|pegylated interferon alfa|
12077198|NCT00006249|Procedure|adjuvant therapy|
12077199|NCT00006248|Drug|cisplatin|
12077200|NCT00006248|Drug|fluorouracil|
12077201|NCT00006248|Drug|paclitaxel|
12077202|NCT00006246|Drug|busulfan|
12077203|NCT00006245|Drug|alvocidib|
12077204|NCT00006245|Drug|paclitaxel|
12077205|NCT00006244|Drug|melphalan|Given IV
12077206|NCT00006244|Biological|recombinant interferon alfa|Given SC
12077207|NCT00006244|Biological|aldesleukin|Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
12077208|NCT00006244|Procedure|in vitro-treated peripheral blood stem cell transplantation|Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
12077209|NCT00006239|Drug|sodium phenylbutyrate|
12077210|NCT00006239|Drug|tretinoin|
12077211|NCT00006237|Biological|interleukin-2|Given IV
12077212|NCT00006237|Biological|filgrastim|Given subcutaneously
12077213|NCT00006237|Biological|interferon alfa|Given IV and subcutaneously
12077214|NCT00006237|Drug|cisplatin|Given IV
12077215|NCT00006237|Drug|dacarbazine|Given IV
12077216|NCT00006237|Drug|vinblastine|Given IV
12077217|NCT00006234|Procedure|peripheral blood stem cell transplantation|
12077218|NCT00006234|Radiation|holmium Ho 166 DOTMP|
12077219|NCT00006233|Biological|therapeutic allogeneic lymphocytes|
12077220|NCT00006233|Drug|cyclosporine|
12077221|NCT00006233|Drug|fludarabine phosphate|
12077222|NCT00006233|Drug|mycophenolate mofetil|
12077223|NCT00006233|Procedure|peripheral blood stem cell transplantation|
12077224|NCT00006233|Radiation|radiation therapy|
12077225|NCT00006232|Drug|dexamethasone|
12077226|NCT00006232|Drug|doxorubicin hydrochloride|
12077227|NCT00006232|Drug|idarubicin|
12077228|NCT00006232|Drug|vincristine sulfate|
12077229|NCT00006231|Procedure|quality-of-life assessment|
12077230|NCT00006231|Procedure|standard follow-up care|
12077231|NCT00006231|Radiation|radiation therapy|
12077232|NCT00006230|Drug|rubitecan|
12077233|NCT00006228|Biological|trastuzumab|Given IV
12077234|NCT00006228|Biological|aldesleukin|Given SC
12077235|NCT00006228|Other|laboratory biomarker analysis|Correlative studies
12077236|NCT00006228|Other|pharmacological study|Correlative studies
12077237|NCT00006227|Drug|Paclitaxel|Given IV
12077238|NCT00006226|Drug|thalidomide|Given PO
12077239|NCT00006226|Other|laboratory biomarker analysis|Correlative studies
12077240|NCT00006221|Drug|ixabepilone|
12077241|NCT00006219|Drug|clarithromycin|
12077242|NCT00006219|Drug|prasterone|
12077243|NCT00006125|Drug|doxorubicin hydrochloride|
12077244|NCT00006125|Drug|topotecan hydrochloride|
12077245|NCT00006124|Drug|celecoxib|Given orally
12077246|NCT00006124|Drug|placebo|Given orally
12077247|NCT00006120|Drug|docetaxel|
12077248|NCT00006120|Drug|paclitaxel|
12077249|NCT00006119|Drug|hydroxyurea|
12077250|NCT00006118|Drug|cisplatin|
12077251|NCT00006118|Drug|gemcitabine hydrochloride|
12077252|NCT00006118|Drug|paclitaxel|
12077253|NCT00006114|Drug|mitoxantrone hydrochloride|
12077254|NCT00006114|Drug|vinorelbine tartrate|
12077255|NCT00006113|Biological|MART-1 antigen|
12077256|NCT00006113|Biological|aldesleukin|
12077257|NCT00006113|Biological|gp100 antigen|
12077258|NCT00006113|Biological|recombinant CD40-ligand|
12077259|NCT00006113|Biological|recombinant interferon gamma|
12077260|NCT00006113|Biological|recombinant interleukin-4|
12077261|NCT00006113|Biological|sargramostim|
12077262|NCT00006113|Biological|therapeutic autologous dendritic cells|
12077263|NCT00006113|Biological|therapeutic tumor infiltrating lymphocytes|
12077264|NCT00006113|Biological|tyrosinase peptide|
12077265|NCT00006113|Radiation|Candida albicans skin test reagent|
12077266|NCT00006110|Biological|trastuzumab|infusion 4 mg/kg load week 1; 2 mg/kg weekly thereafter for 12 weeks
12077267|NCT00006110|Drug|cyclophosphamide|600 mg/m2, intravenous infusion every 3 weeks for four cycles
12077268|NCT00006110|Drug|doxorubicin hydrochloride|60 mg/m2 intravenously, 5-10 minutes, every 3 weeks, up to 12 weeks
12077269|NCT00006110|Drug|paclitaxel|90 mg/m2 weekly, intravenously 1 hour after herceptin, given weekly up to 12 weeks or 175 mg/m2, intravenously every 3 weeks, up to 12 weeks (only if not receiving Herceptin®)
12077270|NCT00006110|Procedure|conventional surgery|Surgical excision will take place 12-13 weeks for the neo-adjuvant herceptin setting and 12-13 weeks in the non-herceptin setting. Surgery will take place prior to chemotherapy in the adjuvant herceptin setting
12077271|NCT00006107|Drug|Taxotere|
12077272|NCT00006107|Procedure|Surgery|
12077273|NCT00006107|Radiation|radiation therapy|
12077274|NCT00006105|Drug|amifostine trihydrate|
12077275|NCT00006105|Drug|cisplatin|
12077276|NCT00006105|Drug|gemcitabine hydrochloride|
12077277|NCT00006105|Procedure|adjuvant therapy|
12077278|NCT00006102|Drug|becatecarin|
12077279|NCT00006101|Drug|eflornithine|Take 500mg of DFMO per day for 12 months
12077280|NCT00006101|Drug|Placebo|Take placebo per day for 12 months
12077281|NCT00006100|Biological|aldesleukin|
12077282|NCT00006100|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes|
12077283|NCT00006100|Drug|fludarabine phosphate|
12077284|NCT00006100|Procedure|peripheral blood stem cell transplantation|
12077285|NCT00006094|Drug|oxaliplatin|Given IV
12077286|NCT00006094|Drug|fluorouracil|Given IV
12077287|NCT00006094|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
12077288|NCT00006093|Drug|cilengitide|
12077289|NCT00006092|Drug|Arsenic Trioxide|
12077290|NCT00006089|Other|Laboratory Biomarker Analysis|Correlative studies
12077291|NCT00006089|Biological|Trastuzumab|Given IV
12077292|NCT00006078|Dietary Supplement|lycopene|
12077293|NCT00006044|Drug|therapeutic testosterone|
12077294|NCT00006042|Biological|filgrastim|
12077295|NCT00006042|Drug|cyclophosphamide|
12077296|NCT00006042|Drug|fludarabine phosphate|
12077297|NCT00006042|Drug|mycophenolate mofetil|
12077298|NCT00006042|Drug|tacrolimus|
12077299|NCT00006042|Procedure|allogeneic bone marrow transplantation|
12077300|NCT00006042|Radiation|radiation therapy|
12077301|NCT00006040|Biological|filgrastim|
12077302|NCT00006040|Drug|etoposide|
12077303|NCT00006040|Procedure|autologous bone marrow transplantation|
12077304|NCT00006040|Procedure|peripheral blood stem cell transplantation|
12077305|NCT00006040|Radiation|yttrium Y 90 monoclonal antibody M195|
12077306|NCT00006029|Drug|gemcitabine hydrochloride|
12077307|NCT00006029|Drug|pegylated liposomal doxorubicin hydrochloride|
12077308|NCT00006029|Drug|vinorelbine tartrate|
12077309|NCT00006028|Drug|cisplatin|
12077310|NCT00006028|Drug|gemcitabine hydrochloride|
12077311|NCT00006027|Drug|cisplatin|
12077312|NCT00006027|Drug|paclitaxel|
12077313|NCT00006027|Procedure|adjuvant therapy|
12077314|NCT00006027|Radiation|radiation therapy|
12077315|NCT00006025|Drug|irinotecan hydrochloride|
12077316|NCT00006025|Drug|temozolomide|
12077317|NCT00006024|Drug|lomustine|
12077318|NCT00006024|Drug|temozolomide|
12077319|NCT00006022|Biological|aldesleukin|
12077320|NCT00006022|Drug|bryostatin 1|
12077321|NCT00006021|Dietary Supplement|ascorbic acid|
12077322|NCT00006021|Drug|arsenic trioxide|
12077323|NCT00006020|Drug|nelarabine|1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
12077324|NCT00006017|Drug|becatecarin|Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1. Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.
12077325|NCT00006016|Drug|thalidomide|Given orally
12077326|NCT00006016|Drug|doxorubicin hydrochloride|Given transarterially (chemoembolization)
12077327|NCT00006016|Other|laboratory biomarker analysis|Correlative studies
12077328|NCT00006015|Biological|trastuzumab|4 mg/kg IV infusion Day 1, then weekly 2 mg/kg IV infusion (on Days 8, 15, & 22)
12077329|NCT00006015|Drug|fluorouracil|500 mg/sq m IV push weekly for 3 weeks, followed by a 1 wk break
12077330|NCT00006015|Drug|leucovorin calcium|500 mg/sq m IV infusion over 2 hours weekly for 3 weeks, then a 1 wk break
12077331|NCT00006015|Drug|oxaliplatin|85 mg/sq m IV infusion over 2 hours Days 1 & 15 of each cycle
12077332|NCT00006011|Drug|Doxorubicin Hydrochloride|Given IV
12077333|NCT00006011|Drug|Cisplatin|Given IV
12077334|NCT00006011|Biological|Filgrastim|Given SC
12077335|NCT00006011|Biological|Pegfilgrastim|Given SC
12077336|NCT00006011|Drug|Paclitaxel|Given IV
12077337|NCT00006010|Drug|docetaxel|
12077338|NCT00006010|Drug|gemcitabine hydrochloride|
12077339|NCT00006007|Drug|gemcitabine hydrochloride|
12077340|NCT00006007|Drug|pemetrexed disodium|
12077341|NCT00006006|Biological|recombinant interferon alfa|
12077342|NCT00006006|Drug|thalidomide|
12077343|NCT00006005|Drug|thalidomide|
12077344|NCT00006004|Drug|carboplatin|
12077345|NCT00006004|Drug|cisplatin|
12077346|NCT00006004|Drug|gemcitabine hydrochloride|
12077347|NCT00006004|Drug|paclitaxel|
12077348|NCT00006003|Drug|semaxanib|Given IV
12077349|NCT00006003|Other|laboratory biomarker analysis|Correlative studies
12077350|NCT00005997|Drug|becatecarin|Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.
12077351|NCT00005990|Drug|tipifarnib|
12077352|NCT00005990|Drug|topotecan hydrochloride|
12077353|NCT00005987|Drug|carmustine|
12077354|NCT00005987|Drug|cyclophosphamide|
12077355|NCT00005987|Drug|dexamethasone|
12077356|NCT00005987|Drug|etoposide|
12077357|NCT00005987|Drug|filgrastim|
12077358|NCT00005987|Drug|mitoxantrone hydrochloride|
12077359|NCT00005987|Drug|recombinant interferon alfa|
12077360|NCT00005987|Drug|sargramostim|
12077361|NCT00005987|Procedure|bone marrow ablation with stem cell support|
12077362|NCT00005987|Procedure|peripheral blood stem cell transplantation|
12077363|NCT00005987|Procedure|radiation therapy|
12077364|NCT00005985|Biological|filgrastim|
12077365|NCT00005985|Drug|carmustine|
12077366|NCT00005985|Drug|cyclophosphamide|
12077367|NCT00005985|Drug|cytarabine|
12077368|NCT00005985|Drug|dexamethasone|
12077369|NCT00005985|Drug|etoposide|
12077370|NCT00005985|Drug|mitoxantrone hydrochloride|
12077371|NCT00005985|Procedure|peripheral blood stem cell transplantation|
12077372|NCT00005985|Radiation|radiation therapy|
12077373|NCT00005984|Drug|cyclophosphamide|intravenously over 2 hours on day 1 and on days -7 and -6
12077374|NCT00005984|Drug|filgrastim|filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
12077375|NCT00005984|Drug|recombinant interferon alfa|Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
12077376|NCT00005984|Procedure|peripheral blood stem cell transplantation|Patients receive the PBSC transplantation on day 0.
12077377|NCT00005984|Procedure|radiation therapy|total body irradiation twice a day on days -4 through -1
12077378|NCT00005983|Radiation|radiation therapy|
12077379|NCT00005983|Procedure|surgery|surgery
12077380|NCT00005982|Drug|nelarabine|Given IV
12077381|NCT00005982|Other|pharmacological study|Correlative studies
12077382|NCT00005981|Drug|O6-benzylguanine|Patients receive O6-benzylguanine (BG) IV over 1 hour. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
12077383|NCT00005981|Drug|carmustine|Carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
12077384|NCT00005980|Drug|pegylated liposomal doxorubicin hydrochloride|
12077385|NCT00005979|Drug|FOLFIRI regimen|
12077386|NCT00005979|Drug|fluorouracil|
12077387|NCT00005979|Drug|irinotecan hydrochloride|
12077388|NCT00005979|Drug|leucovorin calcium|
12077389|NCT00005976|Drug|carboplatin|
12077390|NCT00005976|Drug|pyrazoloacridine|
12077391|NCT00005973|Drug|BMS-214662|Given IV
12077392|NCT00005973|Other|laboratory biomarker analysis|Correlative studies
12077393|NCT00005970|Drug|Aromatase Inhibition Therapy|Given orally
12077394|NCT00005970|Drug|Cyclophosphamide|Given IV
12077395|NCT00005970|Drug|Doxorubicin Hydrochloride|Given IV
12077396|NCT00005970|Other|Laboratory Biomarker Analysis|Correlative studies
12077397|NCT00005970|Drug|Paclitaxel|Given IV
12077398|NCT00005970|Drug|Tamoxifen Citrate|Given orally
12077399|NCT00005970|Biological|Trastuzumab|Given IV
12077400|NCT00005967|Drug|tipifarnib|
12077401|NCT00005966|Biological|recombinant interferon alfa|
12077402|NCT00005966|Drug|thalidomide|
12077403|NCT00005961|Drug|O6-benzylguanine|
12077404|NCT00005961|Drug|carmustine|
12077405|NCT00005957|Radiation|Standard Breast Irradiation|Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
12077406|NCT00005957|Radiation|Breast Radiation plus Regional Radiation|Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
12077407|NCT00005955|Drug|temozolomide|
12077408|NCT00005954|Drug|temozolomide|
12077409|NCT00005952|Biological|filgrastim|
12077410|NCT00005952|Drug|temozolomide|
12077411|NCT00005952|Procedure|peripheral blood stem cell transplantation|
12077412|NCT00005951|Drug|irinotecan hydrochloride|
12077413|NCT00005951|Drug|temozolomide|
12077414|NCT00005949|Biological|aldesleukin|Given SC
12077415|NCT00005949|Biological|gp100:209-217(210M) peptide vaccine|Given SC
12077416|NCT00005949|Other|laboratory biomarker analysis|Correlative studies
12077417|NCT00005945|Drug|cyclophosphamide|Given IV
12077418|NCT00005945|Drug|cytarabine|Given IT
12077419|NCT00005945|Drug|daunorubicin hydrochloride|Given IV
12077420|NCT00005945|Drug|dexamethasone|Given PO
12077421|NCT00005945|Drug|doxorubicin hydrochloride|Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
12077422|NCT00005945|Drug|mercaptopurine|Given PO
12077423|NCT00005945|Drug|methotrexate|Given PO and IT
12077424|NCT00005945|Drug|pegaspargase|Given IM
12077425|NCT00005945|Drug|thioguanine|Given PO
12077426|NCT00005945|Drug|vincristine sulfate|Given IV
12077427|NCT00005945|Radiation|radiation therapy|Undergo radiation therapy
12077428|NCT00005941|Biological|therapeutic allogeneic lymphocytes|
12077429|NCT00005941|Drug|cyclosporine|
12077430|NCT00005941|Drug|fludarabine phosphate|
12077431|NCT00005941|Drug|mycophenolate mofetil|
12077432|NCT00005941|Procedure|peripheral blood stem cell transplantation|
12077433|NCT00005941|Radiation|radiation therapy|
12077434|NCT00005879|Drug|arzoxifene|one tablet daily
12077435|NCT00005879|Drug|Placebo|matched tablet dialy
12077436|NCT00005878|Drug|celecoxib|
12077437|NCT00005867|Biological|bleomycin sulfate|
12077438|NCT00005867|Drug|CHOP regimen|
12077439|NCT00005867|Drug|cyclophosphamide|
12077440|NCT00005867|Drug|doxorubicin hydrochloride|
12077441|NCT00005867|Drug|etoposide|
12077442|NCT00005867|Drug|mitoxantrone hydrochloride|
12077443|NCT00005867|Drug|prednisolone|
12077444|NCT00005867|Drug|vincristine sulfate|
12077445|NCT00005863|Biological|filgrastim|
12077446|NCT00005863|Drug|cytarabine|
12077447|NCT00005863|Drug|daunorubicin hydrochloride|
12077448|NCT00005863|Drug|etoposide|
12077449|NCT00005863|Drug|fludarabine phosphate|
12077450|NCT00005863|Drug|tretinoin|
12077451|NCT00005859|Drug|tipifarnib|
12077452|NCT00005858|Biological|LMB-9 immunotoxin|
12077453|NCT00005856|Drug|oxaliplatin|Given IV
12077454|NCT00005856|Other|pharmacological study|Correlative studies
12077455|NCT00005855|Drug|carmustine|
12077456|NCT00005855|Drug|efaproxiral|
12077457|NCT00005853|Biological|anti-thymocyte globulin|
12077458|NCT00005853|Biological|etanercept|
12077459|NCT00005851|Drug|fludarabine phosphate|Given IV
12077460|NCT00005851|Radiation|total-body irradiation|Undergo TBI
12077461|NCT00005851|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
12077462|NCT00005851|Drug|cyclosporine|Given PO or IV
12077463|NCT00005851|Drug|mycophenolate mofetil|Given PO or IV
12077464|NCT00005851|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
12077465|NCT00005851|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
12077466|NCT00005851|Other|laboratory biomarker analysis|Correlative studies
12077467|NCT00005850|Drug|cisplatin|80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.
12077468|NCT00005850|Drug|fluoxetine|10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.
12077469|NCT00005850|Drug|gemcitabine hydrochloride|1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.
12077470|NCT00005847|Biological|recombinant interferon alfa|
12077471|NCT00005847|Drug|estramustine phosphate sodium|
12077472|NCT00005847|Drug|isotretinoin|
12077473|NCT00005847|Drug|mitoxantrone hydrochloride|
12077474|NCT00005847|Drug|paclitaxel|
12077475|NCT00005847|Drug|vinorelbine ditartrate|
12077476|NCT00005844|Drug|oxaliplatin|
12077477|NCT00005840|Drug|Paclitaxel|Given IV
12077478|NCT00005840|Drug|Cisplatin|Given IV
12077479|NCT00005840|Radiation|Radiation Therapy|Undergo whole abdominal radiation therapy
12077480|NCT00005838|Drug|shark cartilage extract AE-941|Given orally
12077481|NCT00005838|Other|placebo|Given orally
12077482|NCT00005838|Drug|cisplatin|Given IV
12077483|NCT00005838|Drug|vinorelbine tartrate|Given IV
12077484|NCT00005838|Drug|carboplatin|Given IV
12077485|NCT00005838|Drug|paclitaxel|Given IV
12077486|NCT00005838|Radiation|radiation therapy|Undergo radiotherapy
12077487|NCT00005835|Drug|buthionine sulfoximine|Dose fixed at a bolus of 3 gm/M2 given over 30 minutes followed by a continuous infusion of 1 gm/M2/hour for 72 hours (total 72.5 hours).Total daily infusion dose (minus the initial bolus)will be 24 gm/m2/day.
12077488|NCT00005835|Drug|melphalan|The dose level of melphalan will be assigned at study entry onto protocol. There will be 6 dose levels ranging from 20mg/m2/day x 2 days (dose level 1a) to 62.5 mg/m2/day x 2 days (dose level 6a). The starting dose level will be 1a, with a decrease to level 0a (15mg/m2/day x2 days) if there is unacceptable toxicity.
12077489|NCT00005835|Procedure|Peripheral blood stem cell infusion|Stem cells will be infused intravenously on day 0 , 24 hours after BSO continuous infusion is completed.Infused within 1.5 hours of thawing via a central venous catheter over 15-30 minutes.
12077490|NCT00005835|Other|Filgrastim|5 microgram/kg/day , subcutaneous or intravenous, given daily beginning day 0. First dose to begin 4 hours after completion of stem cell infusion and then to continue till ANC >/= 1500 mm3 for three consecutive days.
12077491|NCT00005831|Biological|trastuzumab|Given IV
12077492|NCT00005831|Drug|paclitaxel|Given IV
12077493|NCT00005831|Drug|carboplatin|Given IV
12077494|NCT00005831|Drug|gemcitabine hydrochloride|Given IV
12077572|NCT00005787|Biological|epoetin alfa|
12077495|NCT00005831|Other|laboratory biomarker analysis|Correlative studies
12077496|NCT00005830|Drug|Doxorubicin Hydrochloride|Given IV
12077497|NCT00005830|Drug|Cisplatin|Given IV
12077498|NCT00005830|Radiation|Radiation Therapy|Undergo radiation therapy
12077499|NCT00005825|Drug|cisplatin|
12077500|NCT00005825|Drug|mitomycin C|
12077501|NCT00005825|Drug|tretinoin|
12077502|NCT00005825|Drug|vinorelbine tartrate|
12077503|NCT00005824|Biological|filgrastim|
12077504|NCT00005824|Drug|busulfan|
12077505|NCT00005824|Drug|cyclophosphamide|
12077506|NCT00005824|Procedure|peripheral blood stem cell transplantation|
12077507|NCT00005823|Drug|cytarabine|
12077508|NCT00005823|Drug|daunorubicin hydrochloride|
12077509|NCT00005823|Drug|etoposide|
12077510|NCT00005823|Drug|hydroxyurea|
12077511|NCT00005823|Drug|idarubicin|
12077512|NCT00005823|Drug|mitoxantrone hydrochloride|
12077513|NCT00005823|Drug|thioguanine|
12077514|NCT00005823|Drug|tretinoin|
12077515|NCT00005823|Drug|valspodar|
12077516|NCT00005822|Drug|doxorubicin hydrochloride|Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1. For all subsequent courses, patients receive doxorubicin as in course 1. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
12077517|NCT00005822|Drug|semaxanib|For all subsequent courses, after course 1 patients SU5416 IV over 1 hour twice weekly (on days 1 and 4) beginning on week 2 of course 2. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
12077518|NCT00005822|Procedure|conventional surgery|Patients undergo a modified radical mastectomy.
12077519|NCT00005822|Radiation|radiation therapy|Patients undergo radiotherapy to the chest wall and regional lymph nodes.
12077520|NCT00005822|Drug|tamoxifen|Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.
12077521|NCT00005821|Drug|patent blue V dye|
12077522|NCT00005821|Procedure|conventional surgery|
12077523|NCT00005821|Procedure|lymphangiography|
12077524|NCT00005821|Procedure|radionuclide imaging|
12077525|NCT00005821|Procedure|sentinel lymph node biopsy|
12077526|NCT00005821|Radiation|Technetium Tc 99m human serum albumin colloid|
12077527|NCT00005819|Drug|cisplatin|Patients receive cisplatin IV over 30 minutes on day 7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined.
12077528|NCT00005819|Drug|fenretinide|Patients receive oral fenretinide twice daily for 7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
12077529|NCT00005819|Drug|paclitaxel|Patients receive paclitaxel IV over 3 hours. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined.
12077530|NCT00005817|Drug|becatecarin|Given IV
12077531|NCT00005817|Other|laboratory biomarker analysis|Correlative studies
12077532|NCT00005815|Drug|temozolomide|
12077533|NCT00005815|Drug|thalidomide|
12077534|NCT00005812|Drug|temozolomide|
12077535|NCT00005811|Drug|topotecan hydrochloride|Given IT
12077536|NCT00005811|Other|laboratory biomarker analysis|Correlative studies
12077537|NCT00005808|Drug|motexafin lutetium|Given IV
12077538|NCT00005808|Drug|photodynamic therapy|Undergo laser therapy
12077539|NCT00005808|Procedure|loop electrosurgical excision procedure|Undergo LEEP
12077540|NCT00005808|Other|laboratory biomarker analysis|Correlative studies
12077541|NCT00005807|Drug|BMS-247550|anticancer agent for the treatment of patients with malignant tumors.
12077542|NCT00005803|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous transplantation
12077543|NCT00005803|Procedure|Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation|Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
12077544|NCT00005803|Drug|Carmustine|Given IV
12077545|NCT00005803|Drug|Cyclophosphamide|Given IV
12077546|NCT00005803|Drug|Cyclosporine|Given PO
12077547|NCT00005803|Drug|Cytarabine|Given IV
12077548|NCT00005803|Drug|Etoposide|Given IV
12077549|NCT00005803|Drug|Fludarabine Phosphate|Given IV
12077550|NCT00005803|Other|Laboratory Biomarker Analysis|Correlative studies
12077551|NCT00005803|Drug|Melphalan|Given IV
12077552|NCT00005803|Drug|Mycophenolate Mofetil|Given PO
12077553|NCT00005803|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic transplantation
12077554|NCT00005803|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic transplantation
12077555|NCT00005803|Biological|Therapeutic Autologous Lymphocytes|IV donor lymphocyte infusion
12077556|NCT00005803|Radiation|Total-Body Irradiation|Undergo radiotherapy
12077557|NCT00005802|Biological|aldesleukin|
12077558|NCT00005802|Biological|filgrastim|
12077559|NCT00005802|Biological|therapeutic allogeneic lymphocytes|
12077560|NCT00005802|Drug|cytarabine|
12077561|NCT00005802|Drug|etoposide|
12077562|NCT00005802|Drug|fludarabine phosphate|
12077563|NCT00005802|Drug|methotrexate|
12077564|NCT00005802|Drug|mitoxantrone hydrochloride|
12077565|NCT00005802|Drug|therapeutic hydrocortisone|
12077566|NCT00005802|Radiation|radiation therapy|
12077567|NCT00005797|Drug|busulfan|administered on Day -7 through Day -4. The total dose is 12.8 mg/kg
12077568|NCT00005797|Drug|Cyclophosphamide|administered at a dose of 60 mg/kg on each of two successive days (Days -3 and -2)
12077569|NCT00005797|Drug|VP-16|administered as a single infusion on Day -3. The dose is 60 mg/kg and is calculated on actual body weight unless the patient's weight is >/= 150% of IBW, in which case adjusted body weight will be used.
12077570|NCT00005797|Radiation|Fractionated Total Body Irradiation (FTBI)|FTBI is performed on day -7 through day -4. The total dose of radiation is 1,320 cGy.
12077574|NCT00005787|Biological|recombinant flt3 ligand|
12077575|NCT00005787|Biological|recombinant interleukin-3|
12077576|NCT00005787|Biological|sargramostim|
12077577|NCT00005787|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12077578|NCT00005786|Drug|arsenic trioxide|Given IV
12077579|NCT00005786|Other|laboratory biomarker analysis|Correlative studies
12077580|NCT00005647|Drug|paclitaxel|Patients receive paclitaxel IV over one hour on day 1. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
12077581|NCT00005647|Drug|semaxanib|Patients receive SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
12077582|NCT00005644|Drug|gemcitabine hydrochloride|
12077583|NCT00005644|Drug|paclitaxel|
12077584|NCT00005639|Drug|Azacitidine Injection|subcutaneous injection (SC)
12077585|NCT00005639|Drug|sodium phenylbutyrate|continuous intravenous (CIV)
12077586|NCT00005638|Drug|cisplatin|
12077587|NCT00005638|Drug|irinotecan hydrochloride|
12077588|NCT00005638|Radiation|radiation therapy|
12077589|NCT00005637|Drug|carmustine|
12077590|NCT00005637|Drug|temozolomide|
12077591|NCT00005627|Drug|carboplatin|
12077592|NCT00005627|Drug|docetaxel|
12077593|NCT00005627|Drug|estramustine phosphate sodium|
12077594|NCT00005623|Drug|cyproterone acetate|
12077595|NCT00005623|Procedure|quality-of-life assessment|
12077596|NCT00005622|Drug|cyclophosphamide|Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)
12077597|NCT00005622|Radiation|TBI|FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.
12077598|NCT00005617|Biological|dendritic cell-MART-1 peptide vaccine|Number DC: dependent on the group route of immunization: dependent on the group subjects will receive 3 biweekly vaccinations. In case of grade III-IV toxicity in 1/3 subjects at any dose group or route, up to 6 subjects will be included in that group.
12077599|NCT00005617|Procedure|leukapheresis|Patients require a single leukapheresis to obtain 2x10^9 PBL, which are cryopreserved in RPMI 1640, 20% autologous serum, 10% DMSO. Aliquots are thawed at days -7, 7 and 21 for the first, second, and third immunizations respectively. Blood is drawn at the time of leukapheresis and on the day of the first vaccination for autologous serum, which is sufficient for the cell cultures of all patient groups.
12077600|NCT00005606|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes|
12077601|NCT00005606|Biological|autologous Epstein-Barr virus-specific cytotoxic T lymphocytes|
12077602|NCT00005603|Drug|asparaginase|
12077603|NCT00005603|Drug|cyclophosphamide|
12077604|NCT00005603|Drug|cytarabine|
12077605|NCT00005603|Drug|daunorubicin hydrochloride|
12077606|NCT00005603|Drug|dexamethasone|
12077607|NCT00005603|Drug|doxorubicin hydrochloride|
12077608|NCT00005603|Drug|mercaptopurine|
12077609|NCT00005603|Drug|methotrexate|
12077610|NCT00005603|Drug|prednisone|
12077611|NCT00005603|Drug|thioguanine|
12077612|NCT00005603|Drug|vincristine sulfate|
12077613|NCT00005602|Drug|carboplatin|
12077614|NCT00005602|Drug|cereport|
12077615|NCT00005602|Radiation|radiation therapy|
12077616|NCT00005601|Biological|rituximab|
12077617|NCT00005601|Drug|cisplatin|
12077618|NCT00005601|Drug|cytarabine|
12077619|NCT00005601|Drug|dexamethasone|
12077620|NCT00005601|Drug|sargramostim|
12077621|NCT00005600|Procedure|management of therapy complications|
12077622|NCT00005599|Drug|bryostatin 1|
12077623|NCT00005599|Drug|paclitaxel|
12077624|NCT00005597|Drug|temozolomide|200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
12077625|NCT00005596|Drug|cyclophosphamide|
12077626|NCT00005596|Drug|cytarabine|
12077627|NCT00005596|Drug|daunorubicin hydrochloride|30 mg/m2 IV Day 1 of weeks 16, 17, and 18. Give Week 16 dose if ANC ≥ 500/μL and platelets ≥ 75,000/μL. Continue to give during Weeks 17 and 18, even in the face of uncomplicated myelosuppression
12077628|NCT00005596|Drug|dexamethasone|6 mg/m2/day divided BID for 7 days during weeks 8 and 17.
12077629|NCT00005596|Drug|leucovorin calcium|5 mg/m2/dose of leucovorin will be given PO q12h x 2 doses beginning 48 hours after the start of the MTX.
12077630|NCT00005596|Drug|mercaptopurine|50 mg/m2 dose po qhs Weeks 5 through 13 (total 9 wks) and from Week 24 until the end of consolidation. Only hold for uncomplicated myelosuppression, only if IV MTX course is delayed, until ANC > 500/μL and platelets > 75,000/uL
12077631|NCT00005596|Drug|methotrexate|"IV: 1 gm/m2 given as a 200 mg/m2 bolus over 20 min followed by 800 mg/m2 over 23.6 hours given during Weeks 7, 10, 13, 16, 19, and 22.
~IT: Doses by age, Weeks 7, 10, 13, 16, 19 and 22."
12077632|NCT00005596|Drug|pegaspargase|2,500 IU/m2 will be given IM x 1 on Days 2,3,or 4 of Week 16; > or = 1 day after the IT MTX
12077633|NCT00005596|Drug|thioguanine|60 mg/m2 po qhs during Weeks 20 and 21 (total 14 days). Start week 20 when ANC > or = 500/ul and platelets > or = 75,000/uL. Continue to give all 14 doses despite uncomplicated myelosuppression.
12077634|NCT00005596|Drug|vincristine sulfate|1.5 mg/m2 IV on Day 1 of Weeks 8, 9, 17 and 18 (max 2 mg)
12077635|NCT00005590|Drug|levofloxacin|
12077636|NCT00005589|Biological|filgrastim|
12077637|NCT00005589|Biological|rituximab|
12077638|NCT00005589|Drug|carmustine|
12077639|NCT00005589|Drug|cyclophosphamide|
12077640|NCT00005589|Drug|cytarabine|
12077641|NCT00005589|Drug|etoposide|
12077642|NCT00005589|Drug|melphalan|
12077643|NCT00005589|Procedure|bone marrow ablation with stem cell support|
12077644|NCT00005589|Procedure|peripheral blood stem cell transplantation|
12077645|NCT00005586|Drug|L-leucovorin|
12077646|NCT00005586|Drug|fluorouracil|
12077647|NCT00005586|Procedure|adjuvant therapy|
12077648|NCT00005585|Drug|cyclophosphamide|Given IV
12077649|NCT00005585|Drug|cytarabine|Deoxycytidine analogue which is metabolized to ARA-CTP, a substance which inhibits DNA polymerase.
12077650|NCT00005585|Drug|daunorubicin hydrochloride|Given IV
12077651|NCT00005585|Drug|dexamethasone|Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.
12077652|NCT00005585|Drug|leucovorin calcium|Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)
12077653|NCT00005585|Drug|mercaptopurine|An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine
12077654|NCT00005585|Drug|methotrexate|A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis
12077655|NCT00005585|Drug|pegaspargase|E-Coli asparaginase deaminates asparagine, thus, is lethal for cells which cannot synthesize asparagine.
12077656|NCT00005585|Drug|thioguanine|Given orally
12077657|NCT00005585|Drug|vincristine sulfate|Given IV
12077658|NCT00005584|Biological|bleomycin sulfate|
12077659|NCT00005584|Drug|ABVD regimen|
12077660|NCT00005584|Drug|BEACOPP regimen|
12077661|NCT00005584|Drug|epirubicin hydrochloride|
12077662|NCT00005584|Drug|prednisone|
12077663|NCT00005584|Drug|vinblastine sulfate|
12077664|NCT00005584|Radiation|radiation therapy|
12077665|NCT00005583|Drug|cisplatin|
12077666|NCT00005583|Drug|doxorubicin hydrochloride|
12077667|NCT00005583|Drug|epirubicin hydrochloride|
12077668|NCT00005583|Procedure|adjuvant therapy|
12077669|NCT00005583|Procedure|conventional surgery|
12077670|NCT00005583|Radiation|radiation therapy|
12077671|NCT00005580|Drug|bryostatin 1|
12077672|NCT00005580|Drug|fludarabine phosphate|
12077673|NCT00005579|Drug|dolastatin 10|
12077674|NCT00005095|Other|laboratory biomarker analysis|Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.
12077675|NCT00005095|Other|screening questionnaire administration|Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.
12077676|NCT00005095|Procedure|study of high risk factors|Subjects will be assessed for high risk factors.
12077677|NCT00005087|Biological|filgrastim|
12077678|NCT00005087|Drug|cisplatin|
12077679|NCT00005087|Drug|paclitaxel|
12077680|NCT00005087|Procedure|conventional surgery|
12077681|NCT00005087|Radiation|radiation therapy|
12077682|NCT00005079|Procedure|conventional surgery|
12077683|NCT00005074|Drug|alvocidib|
12077684|NCT00005067|Drug|motexafin lutetium|Given IV
12077685|NCT00005067|Drug|photodynamic therapy|Undergo photodynamic therapy
12077686|NCT00005062|Radiation|radiation therapy|
12077687|NCT00005060|Drug|Taxotere-Cisplatin-5FU|Preoperatively
12077688|NCT00005060|Drug|Immediate surgery|Immediate surgery followed by Taxotere-Cisplatin-5FU
12077689|NCT00005052|Biological|GM2-KLH vaccine|
12077690|NCT00005052|Biological|QS21|
12077691|NCT00005052|Procedure|adjuvant therapy|
12077692|NCT00005051|Drug|carboplatin|
12077693|NCT00005051|Drug|cisplatin|
12077694|NCT00005051|Drug|paclitaxel|
12077695|NCT00005051|Drug|topotecan hydrochloride|
12077696|NCT00005049|Drug|carboplatin|
12077697|NCT00005049|Drug|cisplatin|
12077698|NCT00005049|Drug|floxuridine|
12077699|NCT00005047|Drug|cisplatin|
12077700|NCT00005047|Drug|doxorubicin hydrochloride|
12077701|NCT00005047|Drug|methotrexate|
12077702|NCT00005047|Drug|vinblastine|
12077703|NCT00005044|Drug|Casodex|Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.
12077704|NCT00005044|Drug|Eulexin|Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.
12077705|NCT00005044|Drug|LHRH agonist|LHRH agonist of choice. The manufacturer's instructions should be followed.
12077706|NCT00005044|Radiation|radiation therapy|[Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]
12077707|NCT00005039|Biological|recombinant fowlpox-prostate specific antigen vaccine|Given IM
12077708|NCT00005039|Biological|recombinant vaccinia prostate-specific antigen vaccine|Given intradermally
12077709|NCT00005039|Other|laboratory biomarker analysis|Correlative studies
12077710|NCT00005038|Biological|aldesleukin|
12077711|NCT00005038|Drug|histamine dihydrochloride|
12077712|NCT00005036|Drug|irinotecan hydrochloride|Given IV
12077713|NCT00005036|Drug|oxaliplatin|Given IV
12077714|NCT00005036|Drug|leucovorin calcium|Given IV
12077715|NCT00005036|Drug|fluorouracil|Given IV
12077716|NCT00005036|Procedure|quality-of-life assessment|Ancillary studies
12077717|NCT00005033|Biological|trastuzumab|
12077718|NCT00005033|Procedure|conventional surgery|
12077719|NCT00004936|Drug|iodinated contrast dye|
12077720|NCT00004936|Procedure|computed tomography|
12077721|NCT00004936|Procedure|magnetic resonance imaging|
12077722|NCT00004936|Radiation|gadopentetate dimeglumine|
12077723|NCT00004935|Drug|Herceptin™ (Her)|Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy
12077724|NCT00004935|Drug|Herceptin™ (Her) + chemo|Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy
12077725|NCT00004934|Drug|carboplatin|
12077726|NCT00004934|Drug|epirubicin hydrochloride|
12077727|NCT00004934|Drug|paclitaxel|
12077728|NCT00004934|Procedure|conventional surgery|
12077729|NCT00004932|Drug|imatinib mesylate|
12077730|NCT00004930|Drug|doxorubicin hydrochloride|
12077731|NCT00004924|Drug|irinotecan hydrochloride|
12077738|NCT00004921|Procedure|adjuvant therapy|
12077739|NCT00004921|Procedure|bone marrow ablation with stem cell support|
12077740|NCT00004921|Procedure|peripheral blood stem cell transplantation|
12077741|NCT00004920|Drug|cisplatin|
12077742|NCT00004920|Drug|raltitrexed|
12077743|NCT00004918|Biological|PR1 leukemia peptide vaccine|Given SC
12077744|NCT00004918|Drug|Montanide ISA 51 VG|Given SC
12077745|NCT00004918|Biological|sargramostim|Given SC
12077746|NCT00004918|Other|laboratory biomarker analysis|Correlative studies
12077747|NCT00004917|Biological|epoetin alfa|
12077748|NCT00004917|Drug|cisplatin|
12077749|NCT00004917|Radiation|radiation therapy|
12077750|NCT00004907|Drug|busulfan|
12077751|NCT00004907|Drug|cyclophosphamide|
12077752|NCT00004907|Drug|etoposide|
12077753|NCT00004907|Procedure|allogeneic bone marrow transplantation|
12077754|NCT00004907|Procedure|bone marrow ablation with stem cell support|
12077755|NCT00004907|Procedure|peripheral blood stem cell transplantation|
12077756|NCT00004907|Radiation|radiation therapy|
12077757|NCT00004899|Biological|filgrastim|
12077758|NCT00004899|Drug|busulfan|
12077759|NCT00004899|Drug|etoposide|
12077760|NCT00004899|Procedure|autologous bone marrow transplantation|
12077761|NCT00004896|Drug|busulfan|
12077762|NCT00004896|Drug|cyclophosphamide|
12077763|NCT00004896|Procedure|allogeneic bone marrow transplantation|
12077764|NCT00004896|Procedure|bone marrow ablation with stem cell support|
12077765|NCT00004896|Radiation|radiation therapy|
12077766|NCT00004891|Drug|chemotherapy|
12077767|NCT00004891|Procedure|computed tomography|
12077768|NCT00004891|Procedure|conventional surgery|
12077769|NCT00004891|Procedure|neoadjuvant therapy|
12077770|NCT00004891|Procedure|positron emission tomography|
12077771|NCT00004891|Procedure|radionuclide imaging|
12077772|NCT00004891|Radiation|fludeoxyglucose F 18|
12077773|NCT00004891|Radiation|radiation therapy|
12077774|NCT00004888|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
12077775|NCT00004888|Drug|docetaxel|Given IV
12077776|NCT00004888|Biological|trastuzumab|Given IV
12077777|NCT00004888|Other|laboratory biomarker analysis|Correlative studies
12077778|NCT00004879|Biological|panitumumab|
12077779|NCT00004876|Drug|carboplatin|
12077780|NCT00004876|Drug|thalidomide|
12077781|NCT00004873|Drug|cisplatin|
12077782|NCT00004873|Drug|docetaxel|
12077783|NCT00004873|Drug|epirubicin hydrochloride|
12077784|NCT00004873|Drug|fluorouracil|
12077785|NCT00004871|Drug|azacitidine|
12077786|NCT00004871|Drug|sodium phenylbutyrate|
12077787|NCT00004867|Procedure|conventional surgery|
12077788|NCT00004867|Procedure|positron emission tomography|
12077789|NCT00004867|Procedure|radionuclide imaging|
12077790|NCT00004867|Radiation|fludeoxyglucose F 18|
12077791|NCT00004867|Drug|chemotherapy|
12077792|NCT00004867|Radiation|Radiotherapy|
12077793|NCT00004866|Drug|exatecan mesylate|
12077794|NCT00004859|Drug|carboplatin|Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy
12077795|NCT00004859|Drug|paclitaxel|Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour
12077796|NCT00004859|Drug|thalidomide|Induction Chemotherapy dosing: oral daily, starting Day 1 for 24 months or until disease progression. Concurrent Chemotherapy / Radiotherapy dosing: oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.
12077797|NCT00004859|Radiation|radiation therapy|Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
12077798|NCT00004262|Procedure|conventional surgery|
12077799|NCT00004262|Radiation|3-dimensional conformal radiation therapy|
12077800|NCT00004262|Radiation|stereotactic radiosurgery|
12077801|NCT00004262|Drug|motexafin gadolinium|Given IV
12077802|NCT00004262|Procedure|magnetic resonance imaging|Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets
12077803|NCT00004262|Procedure|spectroscopy|Undergo plasma-atomic emission spectroscopy (DCP-AES)
12077804|NCT00004259|Drug|BCNU 80mg/m2|BCNU 80 mg/m2 will be administered as an intravenous infusion on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58, then every eight weeks for four more cycles for a total of 6 cycles (maximum BCNU dose 1440 mg/m2).
12077805|NCT00004259|Drug|TMZ 200mg/m2|200 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat every 28 days for a total of 12 cycles.
12077806|NCT00004259|Radiation|radiation therapy|1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
12077807|NCT00004259|Drug|CCNU|CCNU at 130 mg/m2 orally every 8 weeks for a total of 6 cycles. Administered on day 1 of the first week of radiotherapy and on day 56, then administered every 8 weeks for four more cycles for a total of 6 cycles.
12077808|NCT00004259|Drug|BCNU 150mg/m2|BCNU 150 mg/m2 will be administered as an intravenous infusion on day 5 of radiotherapy, and it will be repeated every eight weeks for a total of six cycles (maximum total BCNU dose 900 mg/m2).
12077809|NCT00004259|Drug|BCNU 200mg/m2|BCNU 200 mg/m2 will be administered as an intravenous infusion on day 1 of radiotherapy and will be repeated every six weeks for a total of 6 cycles (maximum BCNU dose 1200 mg/m2).
12077810|NCT00004259|Drug|TMZ 150mg/m2 six 6-week cycles|150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 6-week cycles
12077913|NCT00004179|Drug|doxorubicin hydrochloride|
12077811|NCT00004259|Drug|TMZ 150mg/m2 six 8-week cycles|150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 8-week cycles
12077812|NCT00004250|Biological|dactinomycin|
12077813|NCT00004250|Drug|isolated limb perfusion|
12077814|NCT00004250|Drug|melphalan|
12077815|NCT00004245|Drug|sodium salicylate|
12077816|NCT00004244|Biological|recombinant interferon alfa|
12077817|NCT00004244|Biological|recombinant interleukin-12|
12077818|NCT00004241|Drug|tanespimycin|Given IV
12077819|NCT00004241|Other|pharmacological study|Correlative studies
12077820|NCT00004237|Drug|cyclophosphamide|
12077821|NCT00004237|Drug|doxorubicin hydrochloride|
12077822|NCT00004237|Drug|epirubicin hydrochloride|
12077823|NCT00004237|Drug|mitoxantrone hydrochloride|
12077824|NCT00004237|Drug|vinorelbine tartrate|
12077825|NCT00004237|Procedure|conventional surgery|
12077826|NCT00004237|Radiation|radiation therapy|
12077827|NCT00004234|Procedure|management of therapy complications|
12077828|NCT00004234|Radiation|radiation therapy|
12077829|NCT00004231|Biological|aldesleukin|
12077830|NCT00004231|Biological|filgrastim|
12077831|NCT00004231|Biological|recombinant interferon alfa|
12077832|NCT00004231|Drug|busulfan|
12077833|NCT00004231|Drug|cyclophosphamide|
12077834|NCT00004231|Drug|cytarabine|
12077835|NCT00004231|Drug|doxorubicin hydrochloride|
12077836|NCT00004231|Drug|leucovorin calcium|
12077837|NCT00004231|Drug|methotrexate|
12077838|NCT00004231|Drug|prednisone|
12077839|NCT00004231|Drug|teniposide|
12077840|NCT00004231|Drug|vincristine sulfate|
12077841|NCT00004231|Procedure|allogeneic bone marrow transplantation|
12077842|NCT00004231|Procedure|autologous bone marrow transplantation|
12077843|NCT00004231|Procedure|peripheral blood stem cell transplantation|
12077844|NCT00004228|Drug|asparaginase|Given IV
12077845|NCT00004228|Drug|cyclophosphamide|Given IV
12077846|NCT00004228|Drug|cytarabine|Given IV
12077847|NCT00004228|Drug|daunorubicin hydrochloride|Given IV
12077848|NCT00004228|Drug|dexamethasone|Given IV
12077849|NCT00004228|Drug|doxorubicin hydrochloride|Given IV
12077850|NCT00004228|Drug|leucovorin calcium|Given IV
12077851|NCT00004228|Drug|mercaptopurine|Given IV
12077852|NCT00004228|Drug|methotrexate|Given IV
12077853|NCT00004228|Drug|prednisone|Given IV
12077854|NCT00004228|Drug|thioguanine|Given PO
12077855|NCT00004228|Drug|vincristine sulfate|Given IV
12077856|NCT00004228|Radiation|radiation therapy|
12077857|NCT00004227|Biological|cetuximab|
12077858|NCT00004227|Procedure|conventional surgery|
12077859|NCT00004227|Radiation|radiation therapy|
12077860|NCT00004226|Radiation|radiation therapy|
12077861|NCT00004225|Biological|Ad5CMV-p53 gene|
12077862|NCT00004225|Radiation|radiation therapy|
12077863|NCT00004224|Drug|cyclophosphamide|
12077864|NCT00004224|Drug|etoposide|
12077865|NCT00004224|Drug|vincristine sulfate|
12077866|NCT00004224|Procedure|adjuvant therapy|
12077867|NCT00004224|Procedure|conventional surgery|
12077868|NCT00004224|Radiation|radiation therapy|
12077869|NCT00004218|Drug|chlorambucil|
12077870|NCT00004218|Drug|cyclophosphamide|
12077871|NCT00004218|Drug|doxorubicin hydrochloride|
12077872|NCT00004218|Drug|fludarabine phosphate|
12077873|NCT00004218|Drug|prednisolone|
12077874|NCT00004218|Drug|vincristine sulfate|
12077875|NCT00004212|Biological|filgrastim|
12077876|NCT00004212|Drug|exatecan mesylate|
12077877|NCT00004210|Other|loss of heterozygosity analysis|
12077878|NCT00004210|Other|microsatellite instability analysis|
12077879|NCT00004210|Other|mutation analysis|
12077880|NCT00004210|Other|counseling intervention|
12077881|NCT00004208|Drug|ATG + CSA|Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)
12077882|NCT00004208|Behavioral|Supportive care|Patients randomized to this arm will be treated as outpatients.
12077883|NCT00004205|Drug|letrozole|Letrozole 2.5 mg daily oral administration.
12077884|NCT00004205|Drug|tamoxifen citrate|Tamoxifen 20 mg daily oral administration.
12077885|NCT00004196|Biological|recombinant interferon alfa|
12077886|NCT00004196|Procedure|lymphangiography|
12077887|NCT00004196|Drug|Observation|
12077888|NCT00004189|Biological|filgrastim|
12077889|NCT00004189|Drug|becatecarin|
12077890|NCT00004189|Drug|cisplatin|
12077891|NCT00004188|Biological|filgrastim|Given IV
12077892|NCT00004188|Drug|carboplatin|Given IV
12077893|NCT00004188|Drug|cisplatin|Given IV
12077894|NCT00004188|Drug|cyclophosphamide|Given IV
12077895|NCT00004188|Drug|doxorubicin hydrochloride|Given IV
12077896|NCT00004188|Drug|etoposide|Given IV
12077897|NCT00004188|Drug|isotretinoin|Given IV
12077898|NCT00004188|Drug|melphalan|Given IV
12077899|NCT00004188|Drug|topotecan hydrochloride|Given IV
12077900|NCT00004188|Drug|vincristine sulfate|Given IV
12077901|NCT00004188|Procedure|autologous bone marrow transplantation|
12077902|NCT00004188|Procedure|bone marrow ablation with stem cell support|
12077903|NCT00004188|Procedure|conventional surgery|All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy
12077904|NCT00004188|Procedure|peripheral blood stem cell transplantation|
12077905|NCT00004188|Radiation|radiation therapy|After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days
12077906|NCT00004181|Drug|busulfan|
12077907|NCT00004181|Drug|cyclophosphamide|
12077908|NCT00004181|Procedure|allogeneic bone marrow transplantation|
12077909|NCT00004181|Radiation|radiation therapy|
12077910|NCT00004179|Biological|rituximab|
12077915|NCT00004179|Drug|vincristine sulfate|
12077916|NCT00004173|Drug|oxaliplatin|
12077917|NCT00004173|Drug|paclitaxel|
12077918|NCT00004165|Biological|filgrastim|
12077919|NCT00004165|Drug|melphalan|
12077920|NCT00004165|Procedure|peripheral blood stem cell transplantation|
12077921|NCT00004154|Drug|Fenretinide|200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.
12077922|NCT00004154|Other|Placebo|Two placebo capsules for 25 days of 28 day cycle.
12077923|NCT00004153|Genetic|reverse transcriptase-polymerase chain reaction|
12077924|NCT00004153|Procedure|sentinel lymph node biopsy|
12077925|NCT00004150|Drug|fluorouracil|
12077926|NCT00004150|Drug|leucovorin calcium|
12077927|NCT00004150|Procedure|adjuvant therapy|
12077928|NCT00004149|Drug|arsenic trioxide|
12077929|NCT00004147|Drug|incyclinide|
12077930|NCT00004144|Drug|bryostatin 1|
12077931|NCT00004144|Drug|gemcitabine hydrochloride|
12077932|NCT00004143|Drug|Campath, Chemo and/or TBI Allo SCT|Allogeneic PBSC/marrow will be collected/harvested from the donor after granulocyte colony-stimulating factor (G-CSF) priming. The allogeneic PBSCs will be infused as per current institutional practice.
12077933|NCT00004141|Drug|Cisplatin|
12077934|NCT00004141|Drug|dacarbazine|
12077935|NCT00004141|Drug|Granulocyte-macrophage colony-stimulating factor|
12077936|NCT00004138|Procedure|positron emission tomography|
12077937|NCT00004138|Procedure|radionuclide imaging|
12077938|NCT00004138|Radiation|fludeoxyglucose F 18|
12077939|NCT00004135|Biological|filgrastim|
12077940|NCT00004135|Biological|therapeutic allogeneic lymphocytes|
12077941|NCT00004135|Drug|cyclophosphamide|
12077942|NCT00004135|Drug|fludarabine phosphate|
12077943|NCT00004135|Procedure|peripheral blood stem cell transplantation|
12077944|NCT00004129|Radiation|brachytherapy|
12077945|NCT00004129|Radiation|phosphorus P32|
12077946|NCT00004128|Biological|aldesleukin|
12077947|NCT00004128|Biological|filgrastim|
12077948|NCT00004128|Drug|busulfan|
12077949|NCT00004128|Drug|cyclophosphamide|
12077950|NCT00004128|Drug|cytarabine|
12077951|NCT00004128|Drug|daunorubicin hydrochloride|
12077952|NCT00004128|Drug|etoposide|
12077953|NCT00004128|Procedure|autologous bone marrow transplantation|
12077954|NCT00004128|Procedure|peripheral blood stem cell transplantation|
12077955|NCT00004128|Radiation|radiation therapy|
12077956|NCT00004124|Drug|bicalutamide|
12077957|NCT00004124|Drug|goserelin|
12077958|NCT00004124|Drug|mitoxantrone hydrochloride|
12077959|NCT00004124|Drug|prednisone|
12077960|NCT00004115|Radiation|yttrium Y 90 monoclonal antibody HMFG1|
12077961|NCT00004110|Biological|monoclonal antibody 3F8|
12077962|NCT00004110|Drug|etoposide|
12077963|NCT00004110|Drug|isotretinoin|
12077964|NCT00004106|Drug|temozolomide|Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks
12077965|NCT00004103|Drug|cisplatin|
12077966|NCT00004103|Drug|floxuridine|
12077967|NCT00004103|Drug|irinotecan hydrochloride|
12077968|NCT00004103|Procedure|adjuvant therapy|
12077969|NCT00004103|Procedure|conventional surgery|
12077970|NCT00004103|Procedure|neoadjuvant therapy|
12077971|NCT00004099|Drug|cisplatin|
12077972|NCT00004099|Drug|fluorouracil|
12077973|NCT00004099|Drug|leucovorin calcium|
12077974|NCT00004099|Procedure|neoadjuvant therapy|
12077975|NCT00004092|Biological|filgrastim|Given IV or subcutaneously
12077976|NCT00004092|Drug|carboplatin|Given IV
12077977|NCT00004092|Drug|cyclophosphamide|Given IV
12077978|NCT00004092|Drug|doxorubicin hydrochloride|Given IV
12077979|NCT00004092|Drug|paclitaxel|Given IV
12077980|NCT00004092|Drug|thiotepa|Given IV
12077981|NCT00004092|Procedure|peripheral blood stem cell transplantation|Patients receive autologous peripheral blood stem cells
12077982|NCT00004088|Biological|filgrastim|
12077983|NCT00004088|Biological|recombinant interferon alfa|
12077984|NCT00004088|Drug|busulfan|
12077985|NCT00004088|Drug|cyclophosphamide|
12077986|NCT00004088|Drug|melphalan|
12077987|NCT00004088|Drug|pamidronate disodium|
12077988|NCT00004088|Drug|thalidomide|
12077989|NCT00004088|Procedure|peripheral blood stem cell transplantation|
12077990|NCT00004081|Drug|docetaxel|
12077991|NCT00004077|Drug|cisplatin|
12077992|NCT00004077|Drug|ifosfamide|
12077993|NCT00004077|Drug|paclitaxel|
12077994|NCT00004075|Drug|tanespimycin|
12077995|NCT00004072|Drug|O6-benzylguanine|Patients receive O6-benzylguanine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response.
12077996|NCT00004072|Drug|carmustine|Followed 1 hour later by carmustine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response.
12077997|NCT00004067|Biological|herceptin|4 mg/kg loading dose then 2 mg/kg weekly for 1 year.
12077998|NCT00004067|Drug|adriamycin|60 mg/m2 IV push every 21 days for 4 cycles.
12077999|NCT00004067|Drug|cyclophosphamide|600 mg/m2 IV every 21 days for 4 cycles
12078000|NCT00004067|Drug|taxol|175 mg/m2 IV every 21 days for 4 cycles
12078001|NCT00004066|Biological|filgrastim|
12078002|NCT00004066|Drug|docetaxel|
12078003|NCT00004066|Drug|gemcitabine hydrochloride|
12078004|NCT00004065|Drug|tanespimycin|
12078005|NCT00004063|Biological|recombinant interferon alfa|
12078006|NCT00004063|Drug|cisplatin|
12078007|NCT00004063|Drug|gemcitabine hydrochloride|
12078008|NCT00004063|Procedure|hyperthermia treatment|
12078009|NCT00004058|Drug|tetradecanoylphorbol acetate|
12078096|NCT00003941|Procedure|bone marrow ablation with stem cell support|
12078010|NCT00004054|Drug|bicalutamide|Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
12078011|NCT00004054|Drug|estramustine phosphate sodium|280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles
12078012|NCT00004054|Drug|etoposide|50 mg/m^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles
12078013|NCT00004054|Drug|flutamide|Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
12078014|NCT00004054|Drug|paclitaxel|135 mg/m^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles
12078015|NCT00004054|Drug|Luteinizing hormone releasing hormone [LHRH] agonist|Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months
12078016|NCT00004054|Radiation|Radiation therapy|Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.
12078017|NCT00004054|Drug|warfarin|To keep international normalized ratio (INR) > 1.5 and < 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy
12078018|NCT00004031|Biological|rituximab|375 mg/m2 IV every 21 days
12078019|NCT00004031|Drug|CHOP regimen|
12078020|NCT00004031|Drug|carmustine|
12078021|NCT00004031|Drug|cyclophosphamide|
12078022|NCT00004031|Drug|doxorubicin hydrochloride|
12078023|NCT00004031|Drug|etoposide|
12078024|NCT00004031|Drug|prednisone|
12078025|NCT00004031|Drug|vincristine sulfate|
12078026|NCT00004031|Procedure|bone marrow ablation with stem cell support|
12078027|NCT00004031|Procedure|peripheral blood stem cell transplantation|
12078028|NCT00004031|Radiation|radiation therapy|
12078029|NCT00004028|Drug|carmustine|
12078030|NCT00004028|Procedure|conventional surgery|
12078031|NCT00004024|Biological|aldesleukin|
12078032|NCT00004024|Biological|autologous tumor cell vaccine|
12078033|NCT00004024|Biological|muromonab-CD3|
12078034|NCT00004024|Biological|sargramostim|
12078035|NCT00004024|Biological|therapeutic autologous lymphocytes|
12078036|NCT00004024|Procedure|surgical procedure|
12078037|NCT00004024|Radiation|radiation therapy|
12078038|NCT00004017|Procedure|conventional surgery|
12078039|NCT00004017|Radiation|iodine I 131 monoclonal antibody TNT-1/B|
12078040|NCT00004015|Drug|sodium borocaptate|
12078041|NCT00004015|Procedure|adjuvant therapy|
12078042|NCT00004011|Drug|carboplatin|
12078043|NCT00004011|Drug|paclitaxel|
12078044|NCT00004011|Procedure|conventional surgery|
12078045|NCT00004005|Drug|fluorouracil|
12078046|NCT00004005|Drug|irinotecan hydrochloride|
12078047|NCT00004005|Drug|leucovorin calcium|
12078048|NCT00004005|Procedure|conventional surgery|
12078049|NCT00004005|Radiation|radiation therapy|
12078050|NCT00004001|Drug|docetaxel|
12078051|NCT00004001|Drug|estramustine|
12078052|NCT00004001|Drug|mitoxantrone|
12078053|NCT00004001|Drug|prednisone|
12078054|NCT00003994|Procedure|therapeutic conventional surgery|Undergo surgical resection
12078055|NCT00003994|Drug|cisplatin|Given IV
12078056|NCT00003994|Drug|vincristine sulfate|Given IV
12078057|NCT00003994|Drug|fluorouracil|Given IV
12078058|NCT00003994|Drug|amifostine trihydrate|Given IV
12078059|NCT00003994|Drug|carboplatin|Given IV
12078060|NCT00003993|Biological|aldesleukin|
12078061|NCT00003993|Drug|bryostatin 1|
12078062|NCT00003981|Drug|indisulam|
12078063|NCT00003979|Drug|CHS 828|
12078064|NCT00003977|Biological|human papillomavirus 16 E7 peptide|
12078065|NCT00003977|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12078066|NCT00003970|Drug|irinotecan hydrochloride|Given IV
12078067|NCT00003969|Drug|tanespimycin|
12078068|NCT00003966|Drug|defibrotide|
12078069|NCT00003963|Biological|rituximab|Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Week 5-8: Rituxan given every 2 weeks. Week 9-12: Schedule same as week 5-8.
12078070|NCT00003963|Drug|vinorelbine ditartrate|"Week 1-4: Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose.
~Week 5-8: Vinorelbine given weekly x3, with one week off. Week 9-12: Schedule same as week 5-8. Week 13 and following: If subject doesn't have disease progression, they may continue on Vinorelbine until progression or until clinically indicated."
12078071|NCT00003961|Biological|sargramostim|
12078072|NCT00003958|Biological|dactinomycin|Given IV
12078073|NCT00003958|Drug|vincristine sulfate|Given IV
12078074|NCT00003958|Drug|cyclophosphamide|Given IV
12078075|NCT00003958|Procedure|therapeutic conventional surgery|Undergo surgery
12078076|NCT00003958|Radiation|radiation therapy|Undergo radiotherapy
12078077|NCT00003958|Drug|topotecan hydrochloride|Given IV
12078078|NCT00003958|Biological|filgrastim|Given SC
12078079|NCT00003958|Biological|sargramostim|Given SC
12078080|NCT00003958|Other|laboratory biomarker analysis|Correlative studies
12078081|NCT00003955|Biological|dactinomycin|
12078082|NCT00003955|Biological|filgrastim|
12078083|NCT00003955|Biological|pegfilgrastim|
12078084|NCT00003955|Biological|sargramostim|
12078085|NCT00003955|Drug|cyclophosphamide|
12078086|NCT00003955|Drug|irinotecan hydrochloride|
12078087|NCT00003955|Drug|vincristine sulfate|
12078088|NCT00003955|Radiation|radiation therapy|
12078089|NCT00003945|Drug|cisplatin|
12078090|NCT00003945|Drug|topotecan hydrochloride|
12078091|NCT00003941|Biological|bleomycin sulfate|
12078092|NCT00003941|Biological|filgrastim|
12078093|NCT00003941|Drug|cisplatin|
12078094|NCT00003941|Drug|etoposide|
12078095|NCT00003941|Drug|ifosfamide|
12078097|NCT00003941|Procedure|peripheral blood stem cell transplantation|
12078098|NCT00003938|Drug|liposomal amphotericin B|
12078099|NCT00003934|Drug|tretinoin|Given orally
12078100|NCT00003934|Drug|daunorubicin hydrochloride|Given IV
12078101|NCT00003934|Drug|cytarabine|Given IV
12078102|NCT00003934|Drug|mercaptopurine|Given IV
12078103|NCT00003934|Drug|methotrexate|Given IV
12078104|NCT00003934|Drug|arsenic trioxide|Given IV
12078105|NCT00003928|Drug|cisplatin|Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
12078106|NCT00003928|Drug|gemcitabine hydrochloride|Gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
12078107|NCT00003913|Biological|anti-thymocyte globulin|
12078108|NCT00003913|Biological|filgrastim|
12078109|NCT00003913|Drug|busulfan|
12078110|NCT00003913|Drug|cyclophosphamide|
12078111|NCT00003913|Drug|methylprednisolone|
12078112|NCT00003913|Procedure|umbilical cord blood transplantation|
12078113|NCT00003913|Radiation|radiation therapy|
12078114|NCT00003912|Drug|carboplatin|
12078115|NCT00003912|Drug|cisplatin|
12078116|NCT00003912|Drug|doxorubicin hydrochloride|
12078117|NCT00003912|Procedure|conventional surgery|
12078118|NCT00003910|Drug|Cyclophosphamide|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule. In patients showing a partial response, but not a CR, the maximum period of therapy was 1 year.
12078119|NCT00003910|Drug|Methotrexate|Initial treatment consisted of MTX given orally at 10 mg/m2 in divided doses once weekly.
12078120|NCT00003910|Drug|Prednisone|Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days.
12078121|NCT00003909|Drug|motexafin gadolinium|Given IV
12078122|NCT00003909|Radiation|radiation therapy|Undergo radiation therapy
12078123|NCT00003909|Other|pharmacological study|Correlatives studies
12078124|NCT00003906|Drug|Raloxifene|60 mg/day plus placebo for 5 years
12078125|NCT00003906|Drug|Tamoxifen|20 mg/day plus placebo for 5 years
12078126|NCT00003903|Procedure|management of therapy complications|
12078127|NCT00003902|Drug|capecitabine|
12078128|NCT00003902|Drug|vinorelbine tartrate|
12078129|NCT00003901|Other|immunohistochemistry staining method|
12078130|NCT00003901|Procedure|biopsy|
12078131|NCT00003901|Procedure|surgery|
12078132|NCT00003896|Drug|cisplatin|
12078133|NCT00003896|Drug|liposomal doxorubicin|
12078134|NCT00003896|Drug|paclitaxel|
12078135|NCT00003893|Drug|CMF regimen|
12078136|NCT00003893|Drug|cyclophosphamide|
12078137|NCT00003893|Drug|doxorubicin hydrochloride|
12078138|NCT00003893|Drug|epirubicin hydrochloride|
12078139|NCT00003893|Drug|fluorouracil|
12078140|NCT00003893|Drug|methotrexate|
12078141|NCT00003893|Drug|mitomycin C|
12078142|NCT00003893|Drug|mitoxantrone hydrochloride|
12078143|NCT00003893|Procedure|adjuvant therapy|
12078144|NCT00003893|Radiation|radiation therapy|
12078145|NCT00003878|Drug|polifeprosan 20 with carmustine implant|
12078146|NCT00003878|Procedure|conventional surgery|
12078147|NCT00003875|Drug|busulfan|Given PO or IV
12078148|NCT00003875|Drug|etoposide|Given IV
12078149|NCT00003875|Biological|aldesleukin|Given SC
12078150|NCT00003875|Procedure|peripheral blood stem cell transplantation|Undergo autologous or syngeneic stem cell rescue
12078151|NCT00003869|Drug|carboxyamidotriazole|Given PO
12078152|NCT00003869|Other|placebo|Given PO
12078153|NCT00003869|Procedure|quality-of-life assessment|Ancillary studies
12078154|NCT00003869|Other|laboratory biomarker analysis|Correlative studies
12078155|NCT00003865|Drug|toremifene|
12078156|NCT00003863|Genetic|comparative genomic hybridization|
12078157|NCT00003863|Genetic|cytogenetic analysis|
12078158|NCT00003863|Genetic|fluorescence in situ hybridization|
12078159|NCT00003863|Genetic|gene rearrangement analysis|
12078160|NCT00003862|Drug|cisplatin|
12078161|NCT00003862|Drug|fluorouracil|
12078162|NCT00003862|Drug|leucovorin calcium|
12078163|NCT00003862|Drug|paclitaxel|
12078164|NCT00003862|Procedure|conventional surgery|
12078165|NCT00003862|Procedure|neoadjuvant therapy|
12078166|NCT00003862|Radiation|radiation therapy|
12078167|NCT00003861|Other|laboratory biomarker analysis|
12078168|NCT00003857|Drug|tamoxifen citrate|
12078169|NCT00003857|Procedure|adjuvant therapy|
12078170|NCT00003857|Radiation|radiation therapy|
12078171|NCT00003855|Procedure|axillary lymph node dissection|
12078172|NCT00003855|Radiation|whole breast irradiation|
12078173|NCT00003854|Other|immunohistochemistry staining method|
12078174|NCT00003854|Procedure|lymphangiography|
12078175|NCT00003854|Procedure|sentinel lymph node biopsy|
12078176|NCT00003854|Procedure|therapeutic conventional surgery|
12078177|NCT00003854|Radiation|whole breast irradiation|
12078178|NCT00003851|Biological|proteolytic enzymes|
12078179|NCT00003851|Drug|gemcitabine hydrochloride|
12078180|NCT00003851|Procedure|Gonzalez regimen|
12078181|NCT00003843|Drug|irinotecan hydrochloride|
12078182|NCT00003843|Genetic|mutation analysis|
12078183|NCT00003843|Genetic|polymorphism analysis|
12078184|NCT00003838|Other|T-cell replete PBPC allograft|Subjects will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m2 intravenously (IV) over 30 minutes daily x 5 days with or without ATG followed by a PBPC graft targeted to deliver >5x10^6 CD34+ cells /kg.
12078185|NCT00003837|Drug|nelarabine|
12078186|NCT00003833|Genetic|DNA stability analysis|
12078187|NCT00003833|Genetic|gene mapping|
12078188|NCT00003831|Procedure|conventional surgery|
12078189|NCT00003820|Drug|Rituximab|Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.
12078190|NCT00003816|Biological|anti-thymocyte globulin|Given IV
12078191|NCT00003816|Drug|busulfan|Given IV
12078192|NCT00003816|Drug|carboplatin|Given IV
12078193|NCT00003816|Drug|cyclophosphamide|Given IV
12078194|NCT00003816|Drug|etoposide|Given IV
12078195|NCT00003816|Drug|fludarabine phosphate|Given IV
12078196|NCT00003816|Drug|melphalan|Given IV
12078197|NCT00003816|Drug|thiotepa|Given IV
12078198|NCT00003816|Radiation|total-body irradiation|Given twice daily for 3 days
12078199|NCT00003815|Biological|bleomycin sulfate|
12078200|NCT00003815|Drug|carmustine|
12078201|NCT00003815|Drug|cyclophosphamide|
12078202|NCT00003815|Drug|cytarabine|
12078203|NCT00003815|Drug|doxorubicin hydrochloride|
12078204|NCT00003815|Drug|etoposide|
12078205|NCT00003815|Drug|melphalan|
12078206|NCT00003815|Drug|prednisolone|
12078207|NCT00003815|Drug|vincristine sulfate|
12078208|NCT00003815|Procedure|autologous bone marrow transplantation|
12078209|NCT00003815|Radiation|radiation therapy|
12078210|NCT00003803|Drug|cisplatin|
12078211|NCT00003803|Drug|gemcitabine hydrochloride|
12078212|NCT00003803|Radiation|radiation therapy|
12078213|NCT00003800|Other|immunohistochemistry staining method|
12078214|NCT00003800|Other|laboratory biomarker analysis|
12078215|NCT00003800|Procedure|radionuclide imaging|
12078216|NCT00003799|Drug|fluorouracil|Given IV
12078217|NCT00003799|Drug|oxaliplatin|Given IV
12078218|NCT00003799|Radiation|radiation therapy|Undergo radiotherapy
12078219|NCT00003799|Drug|leucovorin calcium|Given IV
12078220|NCT00003799|Procedure|therapeutic conventional surgery|Undergo surgery
12078221|NCT00003796|Drug|irofulven|
12078222|NCT00003793|Genetic|clonality analysis|
12078223|NCT00003793|Genetic|microsatellite instability analysis|
12078224|NCT00003793|Genetic|mutation analysis|
12078225|NCT00003789|Drug|isolated limb perfusion|Undergo isolated limb perfusion
12078226|NCT00003789|Drug|melphalan|Given via limb perfusion
12078227|NCT00003789|Biological|recombinant tumor necrosis factor family protein|Given via slow injection into the arterial line
12078228|NCT00003789|Other|pharmacological study|Correlative studies
12078229|NCT00003789|Other|laboratory biomarker analysis|Correlative studies
12078230|NCT00003788|Drug|carmustine|
12078231|NCT00003788|Drug|lomustine|
12078232|NCT00003788|Drug|porfimer sodium|
12078233|NCT00003788|Drug|procarbazine hydrochloride|
12078234|NCT00003788|Procedure|neoadjuvant therapy|
12078235|NCT00003788|Procedure|surgical procedure|
12078236|NCT00003788|Radiation|radiation therapy|
12078237|NCT00003782|Drug|cyclophosphamide|Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles
12078238|NCT00003782|Drug|docetaxel|Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
12078239|NCT00003782|Drug|doxorubicin|Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
12078240|NCT00003771|Biological|therapeutic estradiol|
12078241|NCT00003771|Drug|norethindrone acetate|
12078242|NCT00003764|Drug|cyclophosphamide|
12078243|NCT00003764|Drug|fludarabine phosphate|
12078244|NCT00003753|Drug|dexamethasone|
12078245|NCT00003753|Drug|floxuridine|
12078246|NCT00003753|Drug|irinotecan hydrochloride|
12078247|NCT00003753|Procedure|adjuvant therapy|
12078248|NCT00003753|Procedure|conventional surgery|
12078249|NCT00003750|Biological|hu14.18-IL2 fusion protein|
12078250|NCT00003749|Procedure|adjuvant therapy|
12078251|NCT00003749|Procedure|conventional surgery|
12078252|NCT00003749|Radiation|brachytherapy|
12078253|NCT00003749|Radiation|radiation therapy|
12078254|NCT00003746|Drug|2-chlorodeoxyadenosine (CDA) daily|Daily administration
12078255|NCT00003746|Drug|2-chlorodeoxyadenosine weekly|Weekly administration
12078256|NCT00003745|Drug|topotecan hydrochloride|
12078257|NCT00003744|Drug|gemcitabine|
12078258|NCT00003741|Biological|monoclonal antibody HeFi-1|
12078259|NCT00003739|Biological|filgrastim|
12078260|NCT00003737|Drug|becatecarin|
12078261|NCT00003732|Drug|carboplatin|
12078262|NCT00003732|Drug|paclitaxel|
12078263|NCT00003732|Drug|topotecan hydrochloride|
12078264|NCT00003730|Drug|fluorouracil|
12078265|NCT00003730|Drug|vinorelbine tartrate|
12078266|NCT00003728|Drug|asparaginase|
12078267|NCT00003728|Drug|cyclophosphamide|
12078268|NCT00003728|Drug|cytarabine|
12078269|NCT00003728|Drug|daunorubicin hydrochloride|
12078270|NCT00003728|Drug|dexamethasone|
12078271|NCT00003728|Drug|doxorubicin hydrochloride|
12078272|NCT00003728|Drug|etoposide|
12078273|NCT00003728|Drug|leucovorin calcium|
12078274|NCT00003728|Drug|mercaptopurine|
12078275|NCT00003728|Drug|methotrexate|
12078276|NCT00003728|Drug|methylprednisolone|
12078277|NCT00003728|Drug|mitoxantrone hydrochloride|
12078278|NCT00003728|Drug|prednisolone|
12078279|NCT00003728|Drug|therapeutic hydrocortisone|
12078280|NCT00003728|Drug|thioguanine|
12078281|NCT00003728|Drug|vincristine sulfate|
12078282|NCT00003728|Drug|vindesine|
12078283|NCT00003728|Procedure|allogeneic bone marrow transplantation|
12078284|NCT00003728|Procedure|peripheral blood stem cell transplantation|
12078285|NCT00003727|Biological|filgrastim|
12078286|NCT00003727|Biological|recombinant interferon alfa|
12078287|NCT00003727|Biological|sargramostim|
12078288|NCT00003727|Biological|therapeutic autologous lymphocytes|
12078289|NCT00003727|Drug|carmustine|
12078290|NCT00003727|Drug|cyclophosphamide|
12078291|NCT00003727|Drug|etoposide|
12078292|NCT00003727|Drug|gemcitabine hydrochloride|
12078293|NCT00003727|Drug|melphalan|
12078294|NCT00003727|Procedure|bone marrow ablation with stem cell support|
12078295|NCT00003727|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12078296|NCT00003702|Biological|Dactinomycin|Given IV
12078297|NCT00003702|Drug|Methotrexate|Given intramuscularly
12078298|NCT00003696|Drug|carboplatin|
12078299|NCT00003696|Drug|cyclophosphamide|
12078300|NCT00003696|Drug|doxorubicin hydrochloride|
12078301|NCT00003696|Drug|etoposide|
12078302|NCT00003696|Drug|paclitaxel|
12078303|NCT00003690|Drug|alvocidib|
12078304|NCT00003690|Drug|carboplatin|
12078305|NCT00003690|Drug|cisplatin|
12078306|NCT00003688|Biological|dactinomycin|
12078307|NCT00003687|Drug|dextromethorphan hydrobromide|
12078308|NCT00003687|Drug|morphine sulfate|
12078309|NCT00003678|Drug|tamoxifen citrate|
12078310|NCT00003678|Procedure|adjuvant therapy|
12078311|NCT00003659|Biological|filgrastim|Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients > 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.
12078312|NCT00003659|Biological|rituximab|Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.
12078313|NCT00003659|Drug|cyclophosphamide|Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.
12078314|NCT00003659|Drug|fludarabine phosphate|Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.
12078315|NCT00003658|Biological|filgrastim|
12078316|NCT00003658|Biological|rituximab|
12078317|NCT00003658|Drug|cyclophosphamide|
12078318|NCT00003658|Drug|pentostatin|
12078319|NCT00003656|Biological|recombinant interferon alfa|
12078320|NCT00003656|Drug|tretinoin liposome|
12078321|NCT00003653|Drug|bicalutamide|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
12078322|NCT00003653|Drug|buserelin|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
12078323|NCT00003653|Drug|cyproterone acetate|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
12078324|NCT00003653|Drug|flutamide|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
12078325|NCT00003653|Drug|goserelin|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
12078417|NCT00003569|Drug|cisplatin|
12078418|NCT00003569|Drug|dimesna|
12078419|NCT00003569|Drug|paclitaxel|
12078420|NCT00003568|Biological|aldesleukin|
12078421|NCT00003568|Biological|gp100 antigen|
12078326|NCT00003653|Drug|leuprolide acetate|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
12078327|NCT00003653|Drug|nilutamide|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
12078328|NCT00003652|Drug|cisplatin|
12078329|NCT00003652|Drug|fluorouracil|
12078330|NCT00003652|Procedure|neoadjuvant therapy|
12078331|NCT00003652|Radiation|radiation therapy|
12078332|NCT00003650|Drug|asparaginase|
12078333|NCT00003650|Drug|cyclophosphamide|
12078334|NCT00003650|Drug|cytarabine|
12078335|NCT00003650|Drug|daunorubicin hydrochloride|
12078336|NCT00003650|Drug|dexamethasone|
12078337|NCT00003650|Drug|etoposide|
12078338|NCT00003650|Drug|mercaptopurine|
12078339|NCT00003650|Drug|methotrexate|
12078340|NCT00003650|Drug|methylprednisolone|
12078341|NCT00003650|Drug|mitoxantrone hydrochloride|
12078342|NCT00003650|Drug|prednisone|
12078343|NCT00003650|Drug|vincristine sulfate|
12078344|NCT00003650|Radiation|radiation therapy|
12078345|NCT00003644|Drug|carboplatin|
12078346|NCT00003644|Drug|paclitaxel|
12078347|NCT00003643|Biological|bleomycin sulfate|
12078348|NCT00003643|Biological|filgrastim|
12078349|NCT00003643|Drug|cisplatin|
12078350|NCT00003643|Drug|etoposide|
12078351|NCT00003643|Drug|paclitaxel|
12078352|NCT00003641|Biological|interferon alfa-2b|Given IV
12078353|NCT00003641|Other|observation|Patients undergo observation for 4 weeks.
12078354|NCT00003637|Drug|cisplatin|
12078355|NCT00003637|Drug|fluorouracil|
12078356|NCT00003637|Radiation|radiation therapy|
12078357|NCT00003636|Drug|carboplatin|
12078358|NCT00003636|Drug|cisplatin|
12078359|NCT00003636|Procedure|conventional surgery|
12078360|NCT00003636|Procedure|neoadjuvant therapy|
12078361|NCT00003633|Drug|docetaxel|
12078362|NCT00003633|Drug|estramustine phosphate sodium|
12078363|NCT00003633|Drug|mitoxantrone hydrochloride|
12078364|NCT00003633|Drug|prednisone|
12078365|NCT00003631|Biological|filgrastim|
12078366|NCT00003631|Drug|carboplatin|
12078367|NCT00003631|Drug|carmustine|
12078368|NCT00003631|Drug|cyclophosphamide|
12078369|NCT00003631|Drug|cytarabine|
12078370|NCT00003631|Drug|etoposide|
12078371|NCT00003631|Drug|ifosfamide|
12078372|NCT00003631|Drug|melphalan|
12078373|NCT00003631|Procedure|bone marrow ablation with stem cell support|
12078374|NCT00003631|Procedure|peripheral blood stem cell transplantation|
12078375|NCT00003631|Radiation|radiation therapy|
12078376|NCT00003613|Drug|O6-benzylguanine|Given IV
12078377|NCT00003613|Drug|carmustine|Given topically
12078378|NCT00003613|Other|laboratory biomarker analysis|Correlative studies
12078379|NCT00003612|Biological|trastuzumab|
12078380|NCT00003612|Drug|carboplatin|
12078381|NCT00003612|Drug|paclitaxel|
12078382|NCT00003611|Drug|acitretin|
12078383|NCT00003611|Other|placebo|
12078384|NCT00003607|Radiation|radiation therapy|
12078385|NCT00003603|Drug|cyclophosphamide|
12078386|NCT00003603|Drug|dexamethasone|
12078387|NCT00003603|Drug|idarubicin|
12078388|NCT00003603|Drug|lomustine|
12078389|NCT00003603|Drug|melphalan|
12078390|NCT00003603|Drug|prednisolone|
12078391|NCT00003602|Drug|cytarabine|
12078392|NCT00003602|Drug|etoposide|
12078393|NCT00003602|Drug|idarubicin|
12078394|NCT00003602|Drug|mitoxantrone hydrochloride|
12078395|NCT00003596|Drug|cisplatin|
12078396|NCT00003596|Drug|fluorouracil|
12078397|NCT00003596|Drug|mitomycin C|
12078398|NCT00003596|Radiation|radiation therapy|
12078399|NCT00003593|Drug|asparaginase|Given IV
12078400|NCT00003593|Drug|cytarabine|Given IT
12078401|NCT00003593|Drug|daunorubicin hydrochloride|Given IV
12078402|NCT00003593|Drug|methotrexate|Given IV
12078403|NCT00003593|Drug|therapeutic hydrocortisone|Given IT
12078404|NCT00003593|Drug|thioguanine|Given IV
12078405|NCT00003590|Drug|hydroxyurea|20 mg/kg/day PO
12078406|NCT00003577|Drug|CMF regimen|
12078407|NCT00003577|Drug|cyclophosphamide|
12078408|NCT00003577|Drug|epirubicin hydrochloride|
12078409|NCT00003577|Drug|fluorouracil|
12078410|NCT00003577|Drug|methotrexate|
12078411|NCT00003577|Procedure|adjuvant therapy|
12078412|NCT00003577|Radiation|radiation therapy|
12078413|NCT00003576|Drug|cisplatin|
12078414|NCT00003576|Drug|fluorouracil|
12078415|NCT00003576|Procedure|surgical procedure|
12078416|NCT00003576|Radiation|radiation therapy|
12078422|NCT00003568|Biological|incomplete Freund's adjuvant|
12078423|NCT00003567|Biological|filgrastim|Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days).
12078424|NCT00003567|Biological|sargramostim|Patients receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days).
12078425|NCT00003567|Biological|therapeutic autologous lymphocytes|
12078426|NCT00003567|Drug|O6-benzylguanine|Patients receive O6-benzylguanine (BG) IV over 1 hour every 6 weeks for 5 courses. Four weeks after the completion of BG and carmustine, patients receive BG IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity.
12078427|NCT00003567|Drug|carmustine|Patients receive carmustine IV over 1 hour every 6 weeks for 5 courses.Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine.
12078428|NCT00003567|Drug|temozolomide|Four weeks after the completion of BG and carmustine, patients receive temozolomide IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity.
12078429|NCT00003567|Procedure|in vitro-treated peripheral blood stem cell transplantation|Approximately 72 hours after the end of the first course of chemotherapy, patients receive reinfusion of retrovirally-transduced hematopoietic stem cells over 5-10 minutes. Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine.
12078430|NCT00003566|Procedure|videothoracoscopy|
12078431|NCT00003565|Drug|docetaxel|
12078432|NCT00003560|Drug|carboplatin|
12078433|NCT00003560|Drug|docetaxel|
12078434|NCT00003558|Drug|carboplatin|
12078435|NCT00003558|Drug|etoposide|
12078436|NCT00003558|Drug|fluorouracil|
12078437|NCT00003558|Drug|leucovorin calcium|
12078438|NCT00003558|Drug|paclitaxel|
12078439|NCT00003553|Other|HLA Matched Peripheral BLood Stem Cells|Cell Product
12078440|NCT00003538|Biological|graft versus host disease prophylaxis/therapy|
12078441|NCT00003538|Procedure|allogeneic bone marrow transplantation|
12078442|NCT00003537|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
12078443|NCT00003536|Drug|antineoplaston A10|
12078444|NCT00003536|Drug|methotrexate|
12078445|NCT00003536|Procedure|alternative product therapy|
12078446|NCT00003536|Procedure|biological therapy|
12078447|NCT00003536|Procedure|biologically based therapies|
12078448|NCT00003536|Procedure|cancer prevention intervention|
12078449|NCT00003536|Procedure|chemotherapy|
12078450|NCT00003536|Procedure|complementary and alternative therapy|
12078451|NCT00003536|Procedure|differentiation therapy|
12078452|NCT00003535|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
12078453|NCT00003534|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Refractory Stage IV Prostate Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078454|NCT00003533|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Metastatic Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078455|NCT00003532|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage III or IV Ovarian Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078456|NCT00003531|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078457|NCT00003530|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Primary Liver Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078458|NCT00003526|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Cancer of Unknown Primary Origin will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078459|NCT00003525|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Cancer of the Cervix and/or Vulva will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078460|NCT00003524|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stomach Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078461|NCT00003522|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Cancer of the Small Intestine will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078514|NCT00003497|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.
12078462|NCT00003521|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Soft Tissue Sarcoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078463|NCT00003520|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Kidney Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078464|NCT00003517|Drug|antineoplaston A10|
12078465|NCT00003517|Drug|antineoplaston AS2-1|
12078466|NCT00003517|Drug|bicalutamide|
12078467|NCT00003517|Drug|flutamide|
12078468|NCT00003517|Drug|leuprolide acetate|
12078469|NCT00003517|Procedure|alternative product therapy|
12078470|NCT00003517|Procedure|antiandrogen therapy|
12078471|NCT00003517|Procedure|biological therapy|
12078472|NCT00003517|Procedure|biologically based therapies|
12078473|NCT00003517|Procedure|cancer prevention intervention|
12078474|NCT00003517|Procedure|complementary and alternative therapy|
12078475|NCT00003517|Procedure|differentiation therapy|
12078476|NCT00003517|Procedure|endocrine therapy|
12078477|NCT00003517|Procedure|hormone therapy|
12078478|NCT00003516|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.
12078479|NCT00003515|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078480|NCT00003514|Drug|antineoplaston A10|
12078481|NCT00003514|Drug|antineoplaston AS2-1|
12078482|NCT00003514|Procedure|alternative product therapy|
12078483|NCT00003514|Procedure|biological therapy|
12078484|NCT00003514|Procedure|biologically based therapies|
12078485|NCT00003514|Procedure|cancer prevention intervention|
12078486|NCT00003514|Procedure|complementary and alternative therapy|
12078487|NCT00003514|Procedure|differentiation therapy|
12078488|NCT00003513|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Metastatic, Recurrent, or Refractory Neuroblastoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078489|NCT00003512|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078490|NCT00003511|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078491|NCT00003509|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078492|NCT00003508|Drug|antineoplaston A10|
12078493|NCT00003508|Drug|antineoplaston AS2-1|
12078494|NCT00003505|Drug|antineoplaston A10|
12078495|NCT00003505|Drug|antineoplaston AS2-1|
12078496|NCT00003505|Procedure|alternative product therapy|
12078497|NCT00003505|Procedure|biological therapy|
12078498|NCT00003505|Procedure|biologically based therapies|
12078499|NCT00003505|Procedure|cancer prevention intervention|
12078500|NCT00003505|Procedure|complementary and alternative therapy|
12078501|NCT00003505|Procedure|differentiation therapy|
12078502|NCT00003502|Drug|antineoplaston A10|
12078503|NCT00003502|Drug|antineoplaston AS2-1|
12078504|NCT00003502|Procedure|alternative product therapy|
12078505|NCT00003502|Procedure|biological therapy|
12078506|NCT00003502|Procedure|biologically based therapies|
12078507|NCT00003502|Procedure|cancer prevention intervention|
12078508|NCT00003502|Procedure|complementary and alternative therapy|
12078509|NCT00003502|Procedure|differentiation therapy|
12078510|NCT00003501|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078511|NCT00003500|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078512|NCT00003499|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078513|NCT00003498|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078515|NCT00003496|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Recurrent or Extensive-Stage Small Cell Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078516|NCT00003495|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV or Recurrent Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078517|NCT00003494|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Recurrent or Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078518|NCT00003492|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078519|NCT00003491|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078520|NCT00003489|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Advanced Head and Neck Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078521|NCT00003487|Drug|antineoplaston A10|
12078522|NCT00003487|Drug|antineoplaston AS2-1|
12078523|NCT00003486|Drug|antineoplaston A10|
12078524|NCT00003486|Drug|antineoplaston AS2-1|
12078525|NCT00003486|Procedure|alternative product therapy|
12078526|NCT00003486|Procedure|biological therapy|
12078527|NCT00003486|Procedure|biologically based therapies|
12078528|NCT00003486|Procedure|cancer prevention intervention|
12078529|NCT00003486|Procedure|complementary and alternative therapy|
12078530|NCT00003486|Procedure|differentiation therapy|
12078531|NCT00003485|Drug|antineoplaston A10, antineoplaston AS2-1 (ANP)|"Patients with metastatic or unresectable Colon Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078532|NCT00003483|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
12078533|NCT00003479|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).
12078534|NCT00003478|Procedure|conventional surgery|
12078535|NCT00003478|Radiation|iodine I 131 monoclonal antibody 81C6|
12078536|NCT00003478|Radiation|radiation therapy|
12078537|NCT00003477|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).
12078538|NCT00003476|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
12078539|NCT00003475|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078540|NCT00003474|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078541|NCT00003473|Drug|Atengenal|Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
12078542|NCT00003473|Drug|Astugenal|Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
12078543|NCT00003472|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal).
12078544|NCT00003471|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078545|NCT00003470|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078546|NCT00003469|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
12078547|NCT00003468|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
12078548|NCT00003467|Drug|carmustine|
12078549|NCT00003467|Drug|polifeprosan 20 with carmustine implant|
12078550|NCT00003467|Procedure|surgical procedure|
12078551|NCT00003466|Drug|temozolomide|
12078552|NCT00003462|Drug|busulfan|
12078553|NCT00003461|Procedure|surgical procedure|
12078554|NCT00003461|Radiation|astatine At 211 monoclonal antibody 81C6|
12078722|NCT00003215|Radiation|radiation therapy|
12078555|NCT00003460|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
12078556|NCT00003459|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)
12078557|NCT00003458|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
12078558|NCT00003457|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
12078559|NCT00003456|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078560|NCT00003455|Drug|antineoplaston A10|
12078561|NCT00003455|Drug|antineoplaston AS2-1|
12078562|NCT00003455|Procedure|alternative product therapy|
12078563|NCT00003455|Procedure|biological therapy|
12078564|NCT00003455|Procedure|biologically based therapies|
12078565|NCT00003455|Procedure|cancer prevention intervention|
12078566|NCT00003455|Procedure|complementary and alternative therapy|
12078567|NCT00003455|Procedure|differentiation therapy|
12078568|NCT00003454|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Breast Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078569|NCT00003453|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078570|NCT00003452|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Bladder Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
12078571|NCT00003440|Drug|paclitaxel|Given IV over 1 hour or 3 hours
12078572|NCT00003440|Biological|trastuzumab|Given IV
12078573|NCT00003440|Procedure|quality-of-life assessment|Ancillary studies
12078574|NCT00003440|Other|laboratory biomarker analysis|Correlative studies
12078575|NCT00003437|Drug|asparaginase|
12078576|NCT00003437|Drug|cyclophosphamide|
12078577|NCT00003437|Drug|cytarabine|
12078578|NCT00003437|Drug|daunorubicin hydrochloride|
12078579|NCT00003437|Drug|dexamethasone|
12078580|NCT00003437|Drug|doxorubicin hydrochloride|
12078581|NCT00003437|Drug|mercaptopurine|
12078582|NCT00003437|Drug|methotrexate|
12078583|NCT00003437|Drug|pegaspargase|
12078584|NCT00003437|Drug|prednisolone|
12078585|NCT00003437|Drug|thioguanine|
12078586|NCT00003437|Drug|vincristine sulfate|
12078587|NCT00003437|Radiation|radiation therapy|
12078588|NCT00003429|Procedure|biopsy|
12078589|NCT00003429|Procedure|computed tomography|
12078590|NCT00003429|Procedure|positron emission tomography|
12078591|NCT00003429|Radiation|fludeoxyglucose F 18|
12078592|NCT00003422|Drug|fluorouracil|
12078593|NCT00003422|Drug|leucovorin calcium|
12078594|NCT00003422|Procedure|adjuvant therapy|
12078595|NCT00003422|Procedure|conventional surgery|
12078596|NCT00003422|Procedure|neoadjuvant therapy|
12078597|NCT00003422|Radiation|radiation therapy|
12078598|NCT00003420|Procedure|computed tomography|
12078599|NCT00003419|Procedure|antiviral therapy|
12078600|NCT00003417|Drug|carmustine|
12078601|NCT00003417|Radiation|radiation therapy|
12078602|NCT00003404|Radiation|Adjuvant Radiotherapy|Adjuvant radiation therapy
12078603|NCT00003389|Drug|Doxorubicin|given IV
12078604|NCT00003389|Drug|Bleomycin|given IV
12078605|NCT00003389|Drug|Vinblastine|given IV
12078606|NCT00003389|Drug|Dacarbazine|given IV
12078607|NCT00003389|Drug|Vincristine|given IV
12078608|NCT00003389|Drug|Mechlorethamine|given IV
12078609|NCT00003389|Drug|Etoposide|given IV
12078610|NCT00003389|Drug|Prednisone|taken orally
12078611|NCT00003389|Drug|Cyclophosphamide|given IV
12078612|NCT00003389|Radiation|Radiotherapy|
12078613|NCT00003385|Drug|carboplatin|
12078614|NCT00003385|Drug|paclitaxel|
12078615|NCT00003385|Drug|pegylated liposomal doxorubicin hydrochloride|
12078616|NCT00003384|Other|Cervical Papanicolaou Test|Undergo Pap smear
12078617|NCT00003384|Procedure|Conization|Undergo cone biopsy
12078618|NCT00003384|Other|Laboratory Biomarker Analysis|Correlative studies
12078619|NCT00003379|Drug|cisplatin|
12078620|NCT00003379|Drug|paclitaxel|
12078621|NCT00003379|Radiation|brachytherapy|
12078622|NCT00003379|Radiation|radiation therapy|
12078623|NCT00003377|Drug|cisplatin|
12078624|NCT00003377|Drug|paclitaxel|
12078625|NCT00003377|Radiation|brachytherapy|
12078626|NCT00003377|Radiation|radiation therapy|
12078627|NCT00003375|Drug|lomustine|
12078628|NCT00003375|Drug|procarbazine hydrochloride|
12078629|NCT00003375|Drug|vincristine sulfate|
12078630|NCT00003375|Radiation|radiation therapy|
12078631|NCT00003354|Procedure|conventional surgery|
12078632|NCT00003354|Procedure|laparoscopic surgery|
12078633|NCT00003342|Biological|filgrastim|
12078634|NCT00003342|Drug|carboplatin|
12078635|NCT00003342|Drug|doxorubicin hydrochloride|
12078636|NCT00003342|Drug|gemcitabine hydrochloride|
12078637|NCT00003342|Drug|paclitaxel|
12078818|NCT00003093|Drug|cyclophosphamide|
12078638|NCT00003336|Biological|anti-thymocyte globulin|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
12078639|NCT00003336|Drug|busulfan|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
12078640|NCT00003336|Drug|cyclophosphamide|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
12078641|NCT00003336|Drug|melphalan|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
12078642|NCT00003336|Drug|methylprednisolone|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
12078643|NCT00003336|Procedure|bone marrow ablation with stem cell support|
12078644|NCT00003336|Procedure|umbilical cord blood transplantation|One day after the conditioning regimen is completed, patients receive the UCBT.
12078645|NCT00003336|Radiation|radiation therapy|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
12078646|NCT00003335|Biological|anti-thymocyte globulin|antithymocyte globulin IV for three days on days -3 to -1
12078647|NCT00003335|Drug|busulfan|If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.
12078648|NCT00003335|Drug|cyclosporine|Cyclosporine begin on day -2 and continue for 6 months.
12078649|NCT00003335|Drug|melphalan|melphalan IV for three days on days -4 to -2
12078650|NCT00003335|Drug|methylprednisolone|Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.
12078651|NCT00003335|Procedure|umbilical cord blood transplantation|On day 0, patients receive umbilical cord blood infusion.
12078652|NCT00003335|Radiation|radiation therapy|9 fractions of total body irradiation (TBI) on days -9 to -5
12078653|NCT00003332|Drug|cisplatin|
12078654|NCT00003332|Drug|gemcitabine hydrochloride|
12078655|NCT00003332|Procedure|surgical procedure|
12078656|NCT00003332|Radiation|radiation therapy|
12078657|NCT00003329|Genetic|gene mapping|
12078658|NCT00003325|Procedure|Sentinel lymph node mapping|Sentinel lymph node mapping
12078659|NCT00003309|Biological|filgrastim|
12078660|NCT00003309|Drug|cisplatin|
12078661|NCT00003309|Drug|cyclophosphamide|
12078662|NCT00003309|Drug|etoposide|
12078663|NCT00003309|Drug|vincristine sulfate|
12078664|NCT00003309|Procedure|adjuvant therapy|
12078665|NCT00003309|Radiation|radiation therapy|
12078666|NCT00003308|Radiation|stereotactic radiosurgery|
12078667|NCT00003292|Drug|ifosfamide|
12078668|NCT00003291|Genetic|cytogenetic analysis|
12078669|NCT00003291|Genetic|mutation analysis|
12078670|NCT00003291|Other|laboratory biomarker analysis|
12078671|NCT00003282|Drug|EF5|Given IV
12078672|NCT00003282|Procedure|therapeutic conventional surgery|Undergo resection
12078673|NCT00003282|Procedure|biopsy|Undergo biopsy
12078674|NCT00003282|Other|pharmacological study|Correlative studies
12078675|NCT00003278|Drug|dexamethasone|
12078676|NCT00003278|Radiation|radiation therapy|
12078677|NCT00003273|Biological|filgrastim|
12078678|NCT00003273|Drug|carboplatin|
12078679|NCT00003273|Drug|cisplatin|
12078680|NCT00003273|Drug|cyclophosphamide|
12078681|NCT00003273|Drug|etoposide|
12078682|NCT00003273|Drug|leucovorin calcium|
12078683|NCT00003273|Drug|methotrexate|
12078684|NCT00003273|Drug|temozolomide|
12078685|NCT00003273|Drug|thiotepa|
12078686|NCT00003273|Drug|vincristine sulfate|
12078687|NCT00003273|Procedure|autologous bone marrow transplantation|
12078688|NCT00003273|Procedure|peripheral blood stem cell transplantation|
12078689|NCT00003273|Radiation|radiation therapy|
12078690|NCT00003268|Drug|amifostine trihydrate|
12078691|NCT00003268|Drug|cytarabine|
12078692|NCT00003268|Drug|idarubicin|
12078693|NCT00003261|Drug|methotrexate|
12078694|NCT00003261|Drug|zidovudine|
12078695|NCT00003261|Procedure|neoadjuvant therapy|
12078696|NCT00003261|Radiation|radiation therapy|
12078697|NCT00003243|Biological|aldesleukin|
12078698|NCT00003243|Biological|filgrastim|
12078699|NCT00003243|Biological|therapeutic allogeneic lymphocytes|
12078700|NCT00003243|Drug|cyclophosphamide|
12078701|NCT00003243|Drug|etoposide|
12078702|NCT00003243|Drug|pegylated liposomal doxorubicin hydrochloride|
12078703|NCT00003216|Drug|fluorouracil|
12078704|NCT00003216|Drug|gemcitabine hydrochloride|
12078705|NCT00003216|Radiation|radiation therapy|
12078706|NCT00003215|Biological|filgrastim|
12078707|NCT00003215|Drug|CHOP regimen|
12078708|NCT00003215|Drug|cyclophosphamide|
12078709|NCT00003215|Drug|cytarabine|
12078710|NCT00003215|Drug|doxorubicin hydrochloride|
12078711|NCT00003215|Drug|etoposide|
12078712|NCT00003215|Drug|leucovorin calcium|
12078713|NCT00003215|Drug|melphalan|
12078714|NCT00003215|Drug|methotrexate|
12078715|NCT00003215|Drug|methylprednisolone|
12078716|NCT00003215|Drug|mitoxantrone hydrochloride|
12078717|NCT00003215|Drug|prednisone|
12078718|NCT00003215|Drug|therapeutic hydrocortisone|
12078719|NCT00003215|Drug|vincristine sulfate|
12078720|NCT00003215|Procedure|bone marrow ablation with stem cell support|
12078721|NCT00003215|Procedure|peripheral blood stem cell transplantation|
12078723|NCT00003204|Drug|cyclophosphamide|Given IV
12078724|NCT00003204|Drug|fludarabine phosphate|Given IV
12078725|NCT00003204|Drug|vincristine sulfate|Given IV
12078726|NCT00003204|Drug|prednisone|Given PO
12078727|NCT00003204|Biological|rituximab|Given IV
12078728|NCT00003204|Other|laboratory biomarker analysis|Correlative studies
12078729|NCT00003199|Drug|tamoxifen citrate|Given orally
12078730|NCT00003199|Drug|busulfan|Given orally
12078731|NCT00003199|Drug|thiotepa|Given IV
12078732|NCT00003199|Drug|melphalan|Given IV
12078733|NCT00003199|Biological|aldesleukin|Given SC
12078734|NCT00003199|Biological|sargramostim|Given SC
12078735|NCT00003199|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell infusion
12078736|NCT00003199|Radiation|radiation therapy|May undergo radiotherapy after completion of IL-2/GM-CSF
12078737|NCT00003194|Biological|filgrastim|
12078738|NCT00003194|Drug|carboplatin|
12078739|NCT00003194|Drug|cyclophosphamide|
12078740|NCT00003194|Drug|etoposide|
12078741|NCT00003194|Drug|thiotepa|
12078742|NCT00003194|Drug|topotecan hydrochloride|
12078743|NCT00003194|Procedure|peripheral blood stem cell transplantation|
12078744|NCT00003179|Drug|medroxyprogesterone|
12078745|NCT00003178|Biological|filgrastim|
12078746|NCT00003178|Drug|cladribine|
12078747|NCT00003178|Drug|idarubicin|
12078748|NCT00003174|Drug|bryostatin 1|
12078749|NCT00003174|Drug|cladribine|
12078750|NCT00003159|Drug|carboplatin|
12078751|NCT00003159|Drug|cisplatin|
12078752|NCT00003159|Drug|docetaxel|
12078753|NCT00003159|Drug|gemcitabine hydrochloride|
12078754|NCT00003159|Drug|ifosfamide|
12078755|NCT00003159|Drug|mitomycin C|
12078756|NCT00003159|Drug|paclitaxel|
12078757|NCT00003159|Drug|vinblastine sulfate|
12078758|NCT00003159|Drug|vinorelbine tartrate|
12078759|NCT00003159|Procedure|conventional surgery|
12078760|NCT00003159|Procedure|neoadjuvant therapy|
12078761|NCT00003153|Biological|therapeutic allogeneic lymphocytes|
12078762|NCT00003145|Drug|Fludarabine Phosphate|Given IV
12078763|NCT00003145|Radiation|Total-Body Irradiation|Undergo TBI
12078764|NCT00003145|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSCT
12078765|NCT00003145|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSCT
12078766|NCT00003145|Drug|Cyclosporine|Given PO or IV
12078767|NCT00003145|Drug|Mycophenolate Mofetil|Given PO or IV
12078768|NCT00003145|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
12078769|NCT00003145|Other|Laboratory Biomarker Analysis|Correlative studies
12078770|NCT00003140|Drug|letrozole|Given orally
12078771|NCT00003140|Other|placebo|Given orally
12078772|NCT00003138|Biological|Erythropoietin|Administered at 150 units/kg subcutaneously every day. Rotating sites should be used. The dose should be rounded off to the nearest 1000 U. The dose should be adjusted based on hematocrit.
12078773|NCT00003138|Biological|Filgrastim|G-CSF should start at a dose of 1 mcg/kg per day or 2.5 mcg/kg three times a week subcutaneously. Rotating sites should be used The dose should be rounded off to the nearest 10 mcg.
12078774|NCT00003138|Procedure|Transfusion|Red cell and platelet transfusions
12078775|NCT00003135|Drug|fluorouracil|
12078776|NCT00003135|Drug|pegylated liposomal doxorubicin hydrochloride|
12078777|NCT00003135|Procedure|hyperthermia treatment|
12078778|NCT00003128|Biological|filgrastim|
12078779|NCT00003128|Drug|ifosfamide|
12078780|NCT00003128|Drug|paclitaxel|
12078781|NCT00003122|Procedure|surgical procedure|
12078782|NCT00003119|Biological|filgrastim|
12078783|NCT00003119|Biological|sargramostim|
12078784|NCT00003119|Drug|carboplatin|
12078785|NCT00003119|Drug|cyclophosphamide|
12078786|NCT00003119|Drug|doxorubicin hydrochloride|
12078787|NCT00003119|Drug|etoposide|
12078788|NCT00003119|Procedure|adjuvant therapy|
12078789|NCT00003119|Procedure|conventional surgery|
12078790|NCT00003119|Radiation|radiation therapy|
12078791|NCT00003116|Biological|filgrastim|Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover.
12078792|NCT00003116|Drug|busulfan|high-dose oral busulfan every 6 hours on days -8 to -5
12078793|NCT00003116|Drug|cyclophosphamide|cyclophosphamide IV twice a day on days -4 and -3
12078794|NCT00003116|Drug|cyclosporine|cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses (allogeneic only)
12078795|NCT00003116|Procedure|bone marrow ablation with stem cell support|
12078796|NCT00003116|Procedure|peripheral blood stem cell transplantation|Allogeneic peripheral blood progenitor cells IV are administered on day 0.
12078797|NCT00003111|Drug|carboplatin|
12078798|NCT00003111|Drug|cisplatin|
12078799|NCT00003111|Drug|irinotecan hydrochloride|
12078800|NCT00003111|Drug|paclitaxel|
12078801|NCT00003111|Procedure|neoadjuvant therapy|
12078802|NCT00003111|Procedure|surgical procedure|
12078803|NCT00003111|Radiation|radiation therapy|
12078804|NCT00003105|Biological|filgrastim|
12078805|NCT00003105|Drug|cisplatin|
12078806|NCT00003105|Drug|doxorubicin hydrochloride|
12078807|NCT00003105|Drug|gemcitabine hydrochloride|
12078808|NCT00003105|Drug|ifosfamide|
12078809|NCT00003105|Drug|paclitaxel|
12078810|NCT00003104|Radiation|radiation therapy|
12078811|NCT00003096|Genetic|DNA ploidy analysis|
12078812|NCT00003096|Genetic|comparative genomic hybridization|
12078813|NCT00003096|Genetic|cytogenetic analysis|
12078814|NCT00003096|Genetic|fluorescence in situ hybridization|
12078815|NCT00003093|Biological|filgrastim|
12078816|NCT00003093|Biological|sargramostim|
12078817|NCT00003093|Drug|carboplatin|
12078819|NCT00003093|Drug|doxorubicin hydrochloride|
12078820|NCT00003093|Drug|etoposide|
12078821|NCT00003093|Procedure|conventional surgery|
12078822|NCT00003093|Procedure|neoadjuvant therapy|
12078823|NCT00003092|Drug|paclitaxel|
12078824|NCT00003067|Biological|aldesleukin|
12078825|NCT00003067|Biological|lymphokine-activated killer cells|
12078826|NCT00003065|Biological|filgrastim|
12078827|NCT00003065|Drug|paclitaxel|
12078828|NCT00003065|Drug|topotecan hydrochloride|
12078829|NCT00003063|Biological|recombinant interferon alfa|
12078830|NCT00003063|Drug|fluorouracil|
12078831|NCT00003063|Drug|leucovorin calcium|
12078832|NCT00003063|Drug|levamisole hydrochloride|
12078833|NCT00003053|Drug|cisplatin|
12078834|NCT00003053|Drug|etoposide|
12078835|NCT00003053|Procedure|adjuvant therapy|
12078836|NCT00003052|Drug|doxorubicin hydrochloride|
12078837|NCT00003052|Drug|etoposide|
12078838|NCT00003052|Drug|ifosfamide|
12078839|NCT00003052|Procedure|conventional surgery|
12078840|NCT00003052|Procedure|hyperthermia treatment|
12078841|NCT00003052|Radiation|radiation therapy|
12078842|NCT00003049|Drug|fluorouracil|
12078843|NCT00003049|Drug|leucovorin calcium|
12078844|NCT00003049|Procedure|conventional surgery|
12078845|NCT00003049|Radiation|radiation therapy|
12078846|NCT00003042|Biological|filgrastim|
12078847|NCT00003042|Drug|cisplatin|
12078848|NCT00003042|Drug|cyclophosphamide|
12078849|NCT00003042|Drug|doxorubicin hydrochloride|
12078850|NCT00003042|Drug|melphalan|
12078851|NCT00003042|Drug|mesna|
12078852|NCT00003042|Drug|paclitaxel|
12078853|NCT00003042|Drug|tamoxifen citrate|
12078854|NCT00003042|Procedure|bone marrow ablation with stem cell support|
12078855|NCT00003042|Procedure|conventional surgery|
12078856|NCT00003042|Procedure|peripheral blood stem cell transplantation|
12078857|NCT00003034|Drug|doxorubicin hydrochloride|Given IV
12078858|NCT00003034|Drug|ranpirnase|Given IV
12078859|NCT00003029|Drug|cisplatin|
12078860|NCT00003029|Drug|fluorouracil|
12078861|NCT00003027|Biological|aldesleukin|
12078862|NCT00003027|Biological|filgrastim|
12078863|NCT00003027|Biological|recombinant interferon alfa|
12078864|NCT00003027|Drug|cisplatin|
12078865|NCT00003027|Drug|dacarbazine|
12078866|NCT00003027|Drug|vinblastine|
12078867|NCT00003026|Drug|bicalutamide|
12078868|NCT00003026|Drug|flutamide|
12078869|NCT00003026|Drug|triptorelin|
12078870|NCT00003026|Radiation|radiation therapy|
12078871|NCT00003023|Biological|BCG vaccine|
12078872|NCT00003023|Biological|monoclonal antibody A1G4 anti-idiotype vaccine|
12078873|NCT00003022|Radiation|iodine I 131 monoclonal antibody 3F8|
12078874|NCT00003016|Drug|tamoxifen citrate|
12078875|NCT00003016|Procedure|adjuvant therapy|
12078876|NCT00003013|Drug|CMF regimen|
12078877|NCT00003013|Drug|cyclophosphamide|
12078878|NCT00003013|Drug|doxorubicin hydrochloride|
12078879|NCT00003013|Drug|fluorouracil|
12078880|NCT00003013|Drug|methotrexate|
12078881|NCT00003013|Drug|paclitaxel|
12078882|NCT00003013|Drug|tamoxifen citrate|
12078883|NCT00003013|Procedure|conventional surgery|
12078884|NCT00003013|Radiation|radiation therapy|
12078885|NCT00002996|Drug|flecainide acetate|
12078886|NCT00002995|Biological|dactinomycin|
12078887|NCT00002995|Biological|filgrastim|
12078888|NCT00002995|Biological|sargramostim|
12078889|NCT00002995|Drug|cyclophosphamide|
12078890|NCT00002995|Drug|vincristine sulfate|
12078891|NCT00002995|Radiation|radiation therapy|
12078892|NCT00002990|Biological|BCG vaccine|
12078893|NCT00002986|Drug|carmustine|
12078894|NCT00002986|Drug|topotecan hydrochloride|
12078895|NCT00002982|Biological|filgrastim|
12078896|NCT00002982|Drug|carboplatin|
12078897|NCT00002982|Drug|carmustine|
12078898|NCT00002982|Drug|cytarabine|
12078899|NCT00002982|Drug|etoposide|
12078900|NCT00002982|Drug|ifosfamide|
12078901|NCT00002982|Drug|melphalan|
12078902|NCT00002982|Procedure|autologous bone marrow transplantation|
12078903|NCT00002982|Procedure|peripheral blood stem cell transplantation|
12078904|NCT00002982|Radiation|radiation therapy|
12078905|NCT00002981|Procedure|positron emission tomography|
12078906|NCT00002981|Radiation|fludeoxyglucose F 18|
12078907|NCT00002981|Radiation|methionine C 11|
12078908|NCT00002976|Drug|conjugated estrogens|
12078909|NCT00002975|Drug|aminolevulinic acid|
12078910|NCT00002968|Biological|edrecolomab|Given IV
12078911|NCT00002968|Other|laboratory biomarker analysis|Correlative studies
12078912|NCT00002963|Drug|aminolevulinic acid hydrochloride|
12078913|NCT00002963|Procedure|conventional surgery|
12078914|NCT00002951|Drug|fluorouracil|
12078915|NCT00002951|Drug|hydroxyurea|
12078916|NCT00002951|Procedure|surgical procedure|
12078917|NCT00002951|Radiation|radiation therapy|
12078918|NCT00002948|Biological|filgrastim|
12078919|NCT00002948|Drug|topotecan hydrochloride|
12078920|NCT00002948|Procedure|bone marrow ablation with stem cell support|
12078921|NCT00002948|Procedure|peripheral blood stem cell transplantation|
12078922|NCT00002944|Drug|carboplatin|Given IV
12078923|NCT00002944|Drug|lomustine|Given IV
12078924|NCT00002944|Drug|procarbazine hydrochloride|Given PO
12078925|NCT00002944|Drug|thioguanine|Given PO
12078926|NCT00002944|Drug|vincristine sulfate|Given PO and IV
12078927|NCT00002943|Drug|carboplatin|
12078928|NCT00002943|Drug|cyclophosphamide|
12078929|NCT00002943|Drug|etoposide|
12078930|NCT00002943|Procedure|autologous bone marrow transplantation|
12078931|NCT00002941|Drug|carmustine|
12078932|NCT00002941|Drug|cyclophosphamide|
12078933|NCT00002941|Drug|etoposide|
12078934|NCT00002941|Drug|mesna|
12078935|NCT00002941|Procedure|peripheral blood stem cell transplantation|
12078936|NCT00002938|Procedure|conventional surgery|Salvage prostatectomy
12078937|NCT00002931|Biological|filgrastim|5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
12078938|NCT00002931|Drug|carboplatin|AUC=7, daily X 3
12078939|NCT00002931|Drug|etoposide|20 mg/kg by 2 hours infusion daily X 3
12078940|NCT00002931|Drug|ifosfamide|3 gm/m2 IV over 30 minutes X 3 days
12078941|NCT00002931|Drug|paclitaxel|425 mg/m2 as 24 hour continuous infusion
12078942|NCT00002931|Procedure|autologous bone marrow transplantation|Given in two divided infusions on day -2 and day 0
12078943|NCT00002931|Procedure|bone marrow ablation with stem cell support|Two cycles of high dose chemotherapy followed by stem cell reinfusion
12078944|NCT00002926|Drug|cytarabine|
12078945|NCT00002926|Drug|etoposide|
12078946|NCT00002926|Drug|idarubicin|
12078947|NCT00002926|Procedure|allogeneic bone marrow transplantation|
12078948|NCT00002926|Procedure|peripheral blood stem cell transplantation|
12078949|NCT00002920|Drug|medroxyprogesterone|
12078950|NCT00002920|Drug|tamoxifen citrate|
12078951|NCT00002920|Procedure|adjuvant therapy|
12078952|NCT00002916|Biological|human papillomavirus 16 E7 peptide|
12078953|NCT00002916|Biological|synthetic human papillomavirus 16 E6 peptide|
12078954|NCT00002916|Procedure|adjuvant therapy|
12078955|NCT00002916|Procedure|surgical procedure|
12078956|NCT00002916|Radiation|radiation therapy|
12078957|NCT00002913|Drug|paclitaxel|Given IV
12078958|NCT00002913|Drug|cisplatin|Given IV
12078959|NCT00002913|Drug|topotecan hydrochloride|Given IV
12078960|NCT00002913|Biological|filgrastim|Given SC
12078961|NCT00002900|Procedure|management of therapy complications|
12078962|NCT00002899|Procedure|adjuvant therapy|
12078963|NCT00002899|Radiation|radiation therapy|
12078964|NCT00002899|Radiation|stereotactic radiosurgery|
12078965|NCT00002898|Biological|dactinomycin|
12078966|NCT00002898|Drug|carboplatin|
12078967|NCT00002898|Drug|cyclophosphamide|
12078968|NCT00002898|Drug|epirubicin hydrochloride|
12078969|NCT00002898|Drug|etoposide|
12078970|NCT00002898|Drug|ifosfamide|
12078971|NCT00002898|Drug|vincristine sulfate|
12078972|NCT00002898|Procedure|adjuvant therapy|
12078973|NCT00002898|Procedure|conventional surgery|
12078974|NCT00002898|Procedure|neoadjuvant therapy|
12078975|NCT00002898|Radiation|brachytherapy|
12078976|NCT00002898|Radiation|radiation therapy|
12078977|NCT00002895|Drug|chemotherapy|
12078978|NCT00002894|Drug|carboplatin|
12078979|NCT00002894|Drug|cisplatin|
12078980|NCT00002894|Drug|paclitaxel|
12078981|NCT00002883|Drug|cisplatin|
12078982|NCT00002883|Drug|fluorouracil|
12078983|NCT00002883|Procedure|adjuvant therapy|
12078984|NCT00002883|Procedure|conventional surgery|
12078985|NCT00002883|Procedure|neoadjuvant therapy|
12078986|NCT00002882|Biological|Aldesleukin (IL-2)|Infusion for a total of 96 hours on days 1-4
12078987|NCT00002882|Biological|Recombinant Interferon Alfa (IFN-A)|"IFN-A Therapy Groups:
~Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
~Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks
~Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5"
12078988|NCT00002882|Drug|Cisplatin|IV Days 1-4
12078989|NCT00002882|Drug|Dacarbazine|IVPB on day 1
12078990|NCT00002882|Drug|Vinblastine|IVPB on days 1-4
12078991|NCT00002882|Procedure|Adjuvant Therapy|Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.
12078992|NCT00002874|Drug|bicalutamide|One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
12078993|NCT00002874|Radiation|radiation therapy|64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra.
12078994|NCT00002874|Drug|placebo|One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
12078995|NCT00002860|Procedure|Surgery|Complete surgical resection of metastatic melanoma
12078996|NCT00002855|Drug|Bicalutamide|
12078997|NCT00002855|Drug|Doxorubicin hydrochloride|
12078998|NCT00002855|Drug|Estramustine Phosphate Sodium|
12078999|NCT00002855|Drug|Flutamide|
12079000|NCT00002855|Drug|Ketoconazole|
12079001|NCT00002855|Drug|Nilutamide|
12079002|NCT00002855|Drug|Therapeutic Hydrocortisone|
12079003|NCT00002855|Drug|Vinblastine|
12079004|NCT00002855|Procedure|Conventional Surgery|Surgical castration
12079005|NCT00002854|Biological|filgrastim|
12079006|NCT00002854|Drug|carboplatin|
12079007|NCT00002854|Drug|cisplatin|
12079008|NCT00002854|Drug|cyclophosphamide|
12079009|NCT00002854|Drug|etoposide|
12079010|NCT00002854|Drug|ifosfamide|
12079011|NCT00002854|Drug|mesna|
12079012|NCT00002854|Drug|paclitaxel|
12079013|NCT00002854|Procedure|peripheral blood stem cell transplantation|
12079014|NCT00002852|Drug|paclitaxel|Given IV
12079015|NCT00002852|Drug|carboplatin|Given IV
12079016|NCT00002852|Procedure|therapeutic conventional surgery|Undergo surgery
12079017|NCT00002851|Procedure|adjuvant therapy|
12079018|NCT00002851|Radiation|low-LET electron therapy|
12079019|NCT00002851|Radiation|low-LET photon therapy|
12079110|NCT00002766|Radiation|radiation therapy|
12079020|NCT00002850|Drug|ciprofloxacin|Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
12079021|NCT00002850|Drug|ofloxacin|Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
12079022|NCT00002850|Drug|160 mg trimethoprim and 800 mg sulfamethoxazole|Begin oral TMP-SMX when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
12079023|NCT00002849|Biological|recombinant interferon alfa|first 2 years
12079024|NCT00002849|Drug|dexamethasone|40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
12079025|NCT00002848|Procedure|psychosocial assessment and care|
12079026|NCT00002848|Procedure|quality-of-life assessment|
12079027|NCT00002847|Biological|aldesleukin|
12079028|NCT00002847|Biological|recombinant interferon alfa|
12079029|NCT00002847|Procedure|conventional surgery|
12079030|NCT00002846|Biological|aldesleukin|
12079031|NCT00002846|Procedure|conventional surgery|
12079032|NCT00002842|Drug|floxuridine|Starting dose of 0.2 mg/kg/day for 14 consecutive days.
12079033|NCT00002842|Drug|fluorouracil|300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
12079034|NCT00002842|Drug|leucovorin calcium|500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
12079035|NCT00002842|Procedure|adjuvant therapy|Chemotherapy given after hepatic resection
12079036|NCT00002842|Procedure|conventional surgery|Hepatic resection
12079037|NCT00002839|Drug|cisplatin|
12079038|NCT00002839|Drug|fluorouracil|
12079039|NCT00002839|Procedure|conventional surgery|
12079040|NCT00002839|Procedure|neoadjuvant therapy|
12079041|NCT00002839|Radiation|radiation therapy|
12079042|NCT00002810|Biological|filgrastim|
12079043|NCT00002810|Drug|melphalan|
12079044|NCT00002810|Procedure|bone marrow ablation with stem cell support|
12079045|NCT00002810|Procedure|peripheral blood stem cell transplantation|
12079046|NCT00002809|Biological|anti-thymocyte globulin|
12079047|NCT00002809|Biological|filgrastim|
12079048|NCT00002809|Biological|sargramostim|
12079049|NCT00002809|Biological|therapeutic immune globulin|
12079050|NCT00002809|Drug|cyclophosphamide|
12079051|NCT00002809|Drug|methotrexate|
12079052|NCT00002809|Drug|tacrolimus|
12079053|NCT00002809|Procedure|allogeneic bone marrow transplantation|
12079054|NCT00002809|Radiation|radiation therapy|
12079055|NCT00002807|Radiation|radiation therapy|45 Gy in 25 fractions over 5 weeks
12079056|NCT00002798|Drug|asparaginase|
12079057|NCT00002798|Drug|daunorubicin hydrochloride|
12079058|NCT00002798|Drug|fludarabine phosphate|
12079059|NCT00002798|Drug|therapeutic hydrocortisone|
12079060|NCT00002798|Procedure|allogeneic bone marrow transplantation|
12079061|NCT00002798|Radiation|3-dimensional conformal radiation therapy|
12079062|NCT00002798|Biological|filgrastim|Given SC
12079063|NCT00002798|Drug|cytarabine|Given IV or IT
12079064|NCT00002798|Drug|idarubicin|Given IV
12079065|NCT00002798|Drug|dexamethasone|Given PO
12079066|NCT00002798|Drug|thioguanine|Given PO
12079067|NCT00002798|Drug|etoposide|Given IV
12079068|NCT00002798|Drug|methotrexate|Given IT
12079069|NCT00002798|Drug|cyclophosphamide|Given IV
12079070|NCT00002798|Biological|aldesleukin|
12079071|NCT00002798|Drug|busulfan|
12079072|NCT00002796|Drug|fluorouracil|Given IV
12079073|NCT00002796|Drug|sodium phenylbutyrate|Given IV
12079074|NCT00002796|Drug|indomethacin|Given orally
12079075|NCT00002796|Biological|recombinant interferon gamma|Given subcutaneously
12079076|NCT00002792|Drug|busulfan|
12079077|NCT00002792|Drug|cyclophosphamide|
12079078|NCT00002792|Drug|cyclosporine|
12079079|NCT00002792|Drug|methotrexate|
12079080|NCT00002792|Drug|tacrolimus|
12079081|NCT00002792|Procedure|allogeneic bone marrow transplantation|
12079082|NCT00002792|Procedure|peripheral blood stem cell transplantation|
12079083|NCT00002778|Biological|sargramostim|
12079084|NCT00002778|Biological|therapeutic allogeneic lymphocytes|
12079085|NCT00002778|Procedure|allogeneic bone marrow transplantation|
12079086|NCT00002778|Procedure|in vitro-treated bone marrow transplantation|
12079087|NCT00002771|Biological|recombinant interferon alfa|
12079088|NCT00002771|Drug|busulfan|
12079089|NCT00002771|Drug|cytarabine|
12079090|NCT00002771|Drug|hydroxyurea|
12079091|NCT00002771|Drug|idarubicin|
12079092|NCT00002771|Procedure|allogeneic bone marrow transplantation|
12079093|NCT00002771|Procedure|autologous bone marrow transplantation|
12079094|NCT00002771|Procedure|peripheral blood stem cell transplantation|
12079095|NCT00002771|Radiation|radiation therapy|
12079096|NCT00002766|Biological|dactinomycin|
12079097|NCT00002766|Biological|sargramostim|
12079098|NCT00002766|Drug|carmustine|
12079099|NCT00002766|Drug|cyclophosphamide|
12079100|NCT00002766|Drug|cytarabine|
12079101|NCT00002766|Drug|daunorubicin hydrochloride|
12079102|NCT00002766|Drug|doxorubicin hydrochloride|
12079103|NCT00002766|Drug|etoposide|
12079104|NCT00002766|Drug|mercaptopurine|
12079105|NCT00002766|Drug|methotrexate|
12079106|NCT00002766|Drug|mitoxantrone hydrochloride|
12079107|NCT00002766|Drug|pegaspargase|
12079108|NCT00002766|Drug|prednisone|
12079109|NCT00002766|Drug|vincristine sulfate|
12079111|NCT00002762|Behavioral|patient interviewing to obtain menstrual history|
12079112|NCT00002762|Procedure|blood sampling|
12079113|NCT00002757|Biological|filgrastim|
12079114|NCT00002757|Drug|cyclophosphamide|
12079115|NCT00002757|Drug|cytarabine|
12079116|NCT00002757|Drug|doxorubicin hydrochloride|
12079117|NCT00002757|Drug|etoposide|
12079118|NCT00002757|Drug|methotrexate|
12079119|NCT00002757|Drug|prednisolone|
12079120|NCT00002757|Drug|prednisone|
12079121|NCT00002757|Drug|therapeutic hydrocortisone|
12079122|NCT00002757|Drug|vincristine sulfate|
12079123|NCT00002756|Biological|filgrastim|
12079124|NCT00002756|Drug|asparaginase|
12079125|NCT00002756|Drug|cyclophosphamide|
12079126|NCT00002756|Drug|cytarabine|
12079127|NCT00002756|Drug|daunorubicin hydrochloride|
12079128|NCT00002756|Drug|etoposide|
12079129|NCT00002756|Drug|leucovorin calcium|
12079130|NCT00002756|Drug|mercaptopurine|
12079131|NCT00002756|Drug|methotrexate|
12079132|NCT00002756|Drug|prednisone|
12079133|NCT00002756|Drug|therapeutic hydrocortisone|
12079134|NCT00002756|Drug|vincristine sulfate|
12079135|NCT00002746|Biological|aldesleukin|
12079136|NCT00002738|Drug|leucovorin calcium|
12079137|NCT00002738|Drug|trimetrexate glucuronate|
12079138|NCT00002727|Radiation|radiation therapy|
12079139|NCT00002720|Drug|tamoxifen citrate|
12079140|NCT00002720|Procedure|conventional surgery|
12079141|NCT00002718|Biological|anti-thymocyte globulin|
12079142|NCT00002718|Biological|filgrastim|
12079143|NCT00002718|Drug|cyclophosphamide|
12079144|NCT00002718|Drug|cytarabine|
12079145|NCT00002718|Drug|methylprednisolone|
12079146|NCT00002718|Drug|thiotepa|
12079147|NCT00002718|Procedure|in vitro-treated bone marrow transplantation|
12079148|NCT00002718|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12079149|NCT00002718|Radiation|radiation therapy|
12079150|NCT00002716|Drug|dexamethasone|
12079151|NCT00002716|Drug|floxuridine|
12079152|NCT00002716|Drug|fluorouracil|
12079153|NCT00002716|Drug|leucovorin calcium|
12079154|NCT00002716|Procedure|laparotomy|
12079155|NCT00002716|Procedure|conventional surgery|
12079156|NCT00002715|Biological|Bleomycin sulfate|A component of the Stanford V regimen.
12079157|NCT00002715|Drug|Stanford V regimen|
12079158|NCT00002715|Drug|Doxorubicin hydrochloride|A component of the Stanford V regimen.
12079159|NCT00002715|Drug|Etoposide|A component of the Stanford V regimen.
12079160|NCT00002715|Drug|Mechlorethamine hydrochloride|A component of the Stanford V regimen.
12079161|NCT00002715|Drug|Prednisone|A component of the Stanford V regimen.
12079162|NCT00002715|Drug|Vinblastine|A component of the Stanford V regimen.
12079163|NCT00002715|Drug|Vincristine sulfate|A component of the Stanford V regimen.
12079164|NCT00002706|Procedure|Laparoscopic Surgery|Undergo vaginal hysterectomy and BSO via laparoscopy
12079165|NCT00002706|Other|Quality-of-Life Assessment|Ancillary studies
12079166|NCT00002706|Procedure|Therapeutic Conventional Surgery|Undergo total abdominal hysterectomy and BSO via conventional laparotomy
12079167|NCT00002702|Biological|aldesleukin|
12079168|NCT00002702|Procedure|adjuvant therapy|
12079169|NCT00002702|Procedure|conventional surgery|
12079170|NCT00002702|Procedure|neoadjuvant therapy|
12079171|NCT00002702|Radiation|radiation therapy|
12079172|NCT00002700|Drug|asparaginase|
12079173|NCT00002700|Drug|cyclophosphamide|
12079174|NCT00002700|Drug|cytarabine|
12079175|NCT00002700|Drug|daunorubicin hydrochloride|
12079176|NCT00002700|Drug|dexamethasone|
12079177|NCT00002700|Drug|doxorubicin hydrochloride|
12079178|NCT00002700|Drug|leucovorin calcium|
12079179|NCT00002700|Drug|mercaptopurine|
12079180|NCT00002700|Drug|methotrexate|
12079181|NCT00002700|Drug|mitoxantrone hydrochloride|
12079182|NCT00002700|Drug|prednisolone|
12079183|NCT00002700|Drug|prednisone|
12079184|NCT00002700|Drug|therapeutic hydrocortisone|
12079185|NCT00002700|Drug|vincristine sulfate|
12079186|NCT00002700|Procedure|allogeneic bone marrow transplantation|
12079187|NCT00002700|Procedure|autologous bone marrow transplantation|
12079188|NCT00002700|Radiation|radiation therapy|
12079189|NCT00002697|Biological|filgrastim|
12079190|NCT00002697|Biological|sargramostim|
12079191|NCT00002697|Drug|carboplatin|
12079192|NCT00002697|Drug|etoposide|
12079193|NCT00002697|Drug|ifosfamide|
12079194|NCT00002697|Procedure|autologous bone marrow transplantation|
12079195|NCT00002697|Procedure|bone marrow ablation with stem cell support|
12079196|NCT00002697|Procedure|peripheral blood stem cell transplantation|
12079197|NCT00002697|Radiation|radiation therapy|
12079198|NCT00002696|Drug|CAF regimen|
12079199|NCT00002696|Drug|CMF regimen|
12079200|NCT00002696|Drug|cyclophosphamide|
12079201|NCT00002696|Drug|doxorubicin hydrochloride|
12079202|NCT00002696|Drug|fluorouracil|
12079203|NCT00002696|Drug|methotrexate|
12079204|NCT00002696|Procedure|adjuvant therapy|
12079205|NCT00002696|Procedure|conventional surgery|
12079206|NCT00002696|Procedure|neoadjuvant therapy|
12079207|NCT00002696|Radiation|radiation therapy|
12079208|NCT00002689|Drug|dexamethasone|
12079209|NCT00002689|Drug|fluorouracil|
12079210|NCT00002689|Radiation|brachytherapy|
12079211|NCT00002689|Radiation|phosphorus P32|
12079212|NCT00002689|Radiation|radiation therapy|
12079213|NCT00002687|Biological|aldesleukin|
12079214|NCT00002684|Drug|cisplatin|
12079215|NCT00002684|Drug|ifosfamide|
12079216|NCT00002684|Drug|paclitaxel|
12079219|NCT00002678|Drug|dexamethasone|40 mg daily for four days given orally and repeated every 28 days should commence on day 29 of the twelfth cycle of induction therapy.
12079220|NCT00002678|Drug|melphalan|9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks
12079221|NCT00002678|Drug|prednisone|100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan
12079222|NCT00002668|Behavioral|Observation|
12079223|NCT00002668|Behavioral|Educational Intervention and Behavioral Skills Training|
12079224|NCT00002663|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)|EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
12079225|NCT00002662|Drug|docetaxel|
12079226|NCT00002662|Drug|paclitaxel|
12079227|NCT00002651|Drug|bicalutamide|Given orally
12079228|NCT00002651|Drug|goserelin acetate|Given subcutaneously
12079229|NCT00002651|Other|clinical observation|Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.
12079230|NCT00002649|Biological|aldesleukin|Given IV
12079231|NCT00002649|Biological|filgrastim|Given SC or IV
12079232|NCT00002649|Drug|cyclophosphamide|Given IV
12079233|NCT00002649|Drug|etoposide|Given IV
12079234|NCT00002649|Radiation|radiation therapy|Undergo radiation therapy
12079235|NCT00002649|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
12079236|NCT00002649|Procedure|bone marrow ablation with stem cell support|Undergo bone marrow ablation with stem cell support
12079237|NCT00002647|Drug|verteporfin|
12079238|NCT00002647|Procedure|conventional surgery|
12079239|NCT00002641|Biological|filgrastim|
12079240|NCT00002641|Drug|doxorubicin hydrochloride|
12079241|NCT00002641|Drug|ifosfamide|
12079242|NCT00002641|Drug|isolated perfusion|
12079243|NCT00002641|Procedure|adjuvant therapy|
12079244|NCT00002641|Procedure|conventional surgery|
12079245|NCT00002641|Radiation|radiation therapy|
12079246|NCT00002633|Drug|bicalutamide|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
12079247|NCT00002633|Drug|buserelin|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
12079248|NCT00002633|Drug|flutamide|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
12079249|NCT00002633|Drug|goserelin|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
12079250|NCT00002633|Drug|leuprolide acetate|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
12079251|NCT00002633|Drug|nilutamide|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
12079252|NCT00002633|Procedure|orchiectomy|Optional orchiectomy
12079253|NCT00002633|Radiation|radiation therapy|Radical Radiation Therapy - (65-69 Gy; 35-37 treatments)
12079254|NCT00002624|Procedure|adjuvant therapy|
12079255|NCT00002624|Procedure|diagnostic thoracoscopy|
12079256|NCT00002624|Procedure|therapeutic thoracoscopy|
12079257|NCT00002624|Procedure|video-assisted surgery|
12079258|NCT00002624|Radiation|radiation therapy|
12079259|NCT00002623|Drug|carboplatin|
12079260|NCT00002623|Drug|cisplatin|
12079261|NCT00002623|Procedure|conventional surgery|
12079262|NCT00002623|Radiation|radiation therapy|
12079263|NCT00002615|Drug|cisplatin|
12079264|NCT00002615|Drug|epirubicin hydrochloride|
12079265|NCT00002615|Drug|fluorouracil|
12079266|NCT00002615|Procedure|conventional surgery|
12079267|NCT00002611|Biological|dactinomycin|
12079268|NCT00002611|Biological|filgrastim|
12079269|NCT00002611|Drug|cyclophosphamide|
12079270|NCT00002611|Drug|doxorubicin hydrochloride|Source and Pharmacology: An anthracycline antibiotic isolated from cultures of Streptomyces peucetius. Binds to DNA and inhibits nucleic acid synthesis, with its major lethal effect occurring during the S phase of the cell cycle. Has some topoisomerase II inhibitory activity. Since it is primarily excreted by the liver, any liver impairment may enhance toxicity. 40% to 50% is excreted in the bile; <5% in the urine. The drug has a very short initial t½ of <20 minutes and a terminal t½ of 17 hours. Animal studies indicate cytotoxic levels persist in tissue for as long as 24 hours.
12079271|NCT00002611|Drug|etoposide|
12079272|NCT00002611|Drug|vincristine sulfate|
12079273|NCT00002611|Procedure|conventional surgery|
12079274|NCT00002611|Radiation|radiation therapy|
12079275|NCT00002610|Biological|dactinomycin|
12079276|NCT00002610|Biological|filgrastim|
12079277|NCT00002610|Drug|carboplatin|
12079278|NCT00002610|Drug|cyclophosphamide|
12079279|NCT00002610|Drug|doxorubicin hydrochloride|
12079280|NCT00002610|Drug|etoposide|
12079281|NCT00002610|Drug|vincristine sulfate|IV
12079282|NCT00002610|Procedure|conventional surgery|
12079283|NCT00002610|Radiation|radiation therapy|
12079284|NCT00002608|Drug|cisplatin|
12079285|NCT00002608|Drug|doxorubicin hydrochloride|
12079286|NCT00002608|Drug|tamoxifen citrate|
12079287|NCT00002608|Procedure|conventional surgery|
12079288|NCT00002608|Radiation|radiation therapy|
12079289|NCT00002598|Biological|recombinant interferon alfa|
12079290|NCT00002598|Biological|sargramostim|
12079291|NCT00002598|Drug|cyclophosphamide|
12079292|NCT00002598|Drug|cytarabine|
12079293|NCT00002598|Drug|etoposide|
12079294|NCT00002598|Drug|methotrexate|
12079295|NCT00002598|Drug|mitoxantrone hydrochloride|
12079296|NCT00002598|Procedure|bone marrow ablation with stem cell support|
12079297|NCT00002598|Radiation|radiation therapy|
12079298|NCT00002596|Biological|bleomycin sulfate|
12079299|NCT00002596|Biological|filgrastim|
12079300|NCT00002596|Drug|carboplatin|
12079301|NCT00002596|Drug|cisplatin|
12079302|NCT00002596|Drug|cyclophosphamide|
12079303|NCT00002596|Drug|etoposide|
12079304|NCT00002596|Procedure|autologous bone marrow transplantation|
12079305|NCT00002596|Procedure|bone marrow ablation with stem cell support|
12079306|NCT00002596|Procedure|conventional surgery|
12079307|NCT00002596|Procedure|peripheral blood stem cell transplantation|
12079308|NCT00002596|Radiation|radiation therapy|
12079309|NCT00002594|Biological|Sargramostim|Given IV
12079310|NCT00002594|Drug|cyclophosphamide|Given IV
12079311|NCT00002594|Drug|melphalan|Given IV
12079312|NCT00002594|Procedure|autologous bone marrow transplantation|
12079313|NCT00002594|Procedure|bone marrow ablation with stem cell support|
12079314|NCT00002594|Procedure|peripheral blood stem cell transplantation|
12079315|NCT00002589|Biological|aldesleukin|
12079316|NCT00002589|Biological|muromonab-CD3|
12079317|NCT00002589|Biological|therapeutic autologous lymphocytes|
12079318|NCT00002589|Procedure|adjuvant therapy|
12079319|NCT00002586|Drug|13-cis retinoic acid|
12079320|NCT00002586|Dietary Supplement|Tocopherol|
12079321|NCT00002569|Drug|lomustine|
12079322|NCT00002569|Drug|procarbazine hydrochloride|
12079323|NCT00002569|Drug|vincristine sulfate|
12079324|NCT00002569|Radiation|radiation therapy|
12079325|NCT00002560|Biological|monoclonal antibody 3F8|
12079326|NCT00002560|Biological|sargramostim|
12079327|NCT00002558|Biological|filgrastim|
12079328|NCT00002558|Drug|carboplatin|
12079329|NCT00002558|Drug|etoposide|
12079330|NCT00002558|Drug|ifosfamide|
12079331|NCT00002558|Drug|paclitaxel|
12079332|NCT00002558|Procedure|peripheral blood stem cell transplantation|
12079333|NCT00002556|Drug|vincristine sulfate|Given IV
12079334|NCT00002556|Drug|carmustine|Given IV
12079335|NCT00002556|Drug|melphalan|Given PO
12079336|NCT00002556|Drug|cyclophosphamide|Given IV
12079337|NCT00002556|Drug|prednisone|Given PO
12079338|NCT00002556|Biological|recombinant interferon alfa-2b|Given SC
12079339|NCT00002556|Other|laboratory biomarker analysis|Correlative studies
12079340|NCT00002546|Drug|cisplatin|
12079341|NCT00002546|Drug|ifosfamide|
12079342|NCT00002546|Procedure|adjuvant therapy|
12079343|NCT00002546|Radiation|radiation therapy|
12079344|NCT00002544|Drug|docetaxel|
12079345|NCT00002544|Drug|mitoxantrone hydrochloride|
12079346|NCT00002528|Drug|tamoxifen citrate|20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
12079347|NCT00002528|Procedure|conventional surgery|Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
12079348|NCT00002528|Radiation|radiation therapy|No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.
12079349|NCT00002528|Procedure|Axillary clearance|Axillary node dissection.
12079350|NCT00002523|Drug|fluorouracil|
12079351|NCT00002523|Drug|leucovorin calcium|
12079352|NCT00002523|Procedure|conventional surgery|
12079353|NCT00002523|Radiation|radiation therapy|
12079354|NCT00002522|Drug|cisplatin|
12079355|NCT00002522|Drug|cyclophosphamide|
12079356|NCT00002522|Drug|etoposide|
12079357|NCT00002522|Procedure|autologous bone marrow transplantation|
12079358|NCT00002522|Procedure|bone marrow ablation with stem cell support|
12079359|NCT00002522|Procedure|peripheral blood stem cell transplantation|
12079360|NCT00002522|Procedure|syngeneic bone marrow transplantation|
12079361|NCT00002522|Radiation|radiation therapy|
12079362|NCT00002521|Drug|cisplatin|
12079363|NCT00002521|Drug|cyclophosphamide|
12079364|NCT00002521|Drug|etoposide|
12079365|NCT00002521|Procedure|autologous bone marrow transplantation|
12079366|NCT00002521|Procedure|bone marrow ablation with stem cell support|
12079367|NCT00002521|Procedure|peripheral blood stem cell transplantation|
12079368|NCT00002521|Procedure|syngeneic bone marrow transplantation|
12079369|NCT00002521|Radiation|radiation therapy|
12079370|NCT00002517|Drug|cytarabine|
12079371|NCT00002517|Drug|daunorubicin hydrochloride|
12079372|NCT00002517|Drug|dexamethasone|
12079375|NCT00002517|Drug|mitoxantrone hydrochloride|
12079376|NCT00002517|Drug|thioguanine|
12079377|NCT00002517|Procedure|allogeneic bone marrow transplantation|
12079378|NCT00002517|Radiation|radiation therapy|
12079379|NCT00002515|Biological|filgrastim|
12079380|NCT00002515|Drug|carboplatin|
12079381|NCT00002515|Drug|thiotepa|
12079382|NCT00002515|Drug|topotecan hydrochloride|
12079383|NCT00002515|Procedure|autologous bone marrow transplantation|
12079384|NCT00002515|Procedure|bone marrow ablation with stem cell support|
12079385|NCT00002515|Procedure|in vitro-treated bone marrow transplantation|
12079386|NCT00002514|Biological|sargramostim|
12079387|NCT00002514|Drug|asparaginase|
12079388|NCT00002514|Drug|cyclophosphamide|
12079389|NCT00002514|Drug|cytarabine|
12079390|NCT00002514|Drug|daunorubicin hydrochloride|
12079391|NCT00002514|Drug|dexamethasone|
12079392|NCT00002514|Drug|etoposide|
12079393|NCT00002514|Drug|imatinib mesylate|
12079394|NCT00002514|Drug|leucovorin calcium|
12079395|NCT00002514|Drug|mercaptopurine|
12079396|NCT00002514|Drug|methotrexate|
12079397|NCT00002514|Drug|prednisone|
12079398|NCT00002514|Drug|thioguanine|
12079399|NCT00002514|Drug|vincristine sulfate|
12079400|NCT00002514|Procedure|allogeneic bone marrow transplantation|
12079401|NCT00002514|Procedure|autologous bone marrow transplantation|
12079402|NCT00002514|Procedure|peripheral blood stem cell transplantation|
12079403|NCT00002514|Radiation|radiation therapy|
12079404|NCT00002511|Radiation|low-LET photon therapy|
12079405|NCT00002490|Biological|BCG vaccine|
12079406|NCT00002490|Drug|mitomycin C|
12079407|NCT00002490|Radiation|radiation therapy|
12079408|NCT00002484|Radiation|radiation therapy|
12079409|NCT00002475|Biological|allogeneic tumor cell vaccine|
12079410|NCT00002475|Biological|autologous tumor cell vaccine|
12079411|NCT00002475|Biological|recombinant interferon alfa|
12079412|NCT00002475|Biological|recombinant interferon gamma|
12079413|NCT00002475|Biological|sargramostim|
12079414|NCT00002475|Drug|cyclophosphamide|
12079415|NCT00002474|Drug|carboplatin|
12079416|NCT00002474|Drug|cyclophosphamide|
12079417|NCT00002474|Drug|mitoxantrone hydrochloride|
12079418|NCT00002474|Procedure|autologous bone marrow transplantation|
12079419|NCT00002474|Procedure|bone marrow ablation with stem cell support|
12079420|NCT00002473|Procedure|conventional surgery|
12079421|NCT00002472|Drug|cisplatin|
12079422|NCT00002472|Drug|etoposide|
12079423|NCT00002472|Procedure|conventional surgery|
12079424|NCT00002472|Procedure|neoadjuvant therapy|
12079425|NCT00002472|Radiation|radiation therapy|
12079426|NCT00002470|Biological|recombinant interferon alfa|
12079427|NCT00002470|Drug|fluorouracil|
12079428|NCT00002455|Biological|Corynebacterium granulosum P40|
12079429|NCT00002455|Procedure|adjuvant therapy|
12079430|NCT00052156|Biological|CancerVax vaccine (CANVAXIN)|
12079431|NCT00052130|Biological|CancerVax vaccine (CANVAXIN)|
12079432|NCT00051818|Behavioral|Treatment interruption/reinitiation schedule|
12079433|NCT00052117|Drug|capravirine|
12079434|NCT00052117|Drug|Kaletra|
12079435|NCT00052117|Drug|2 NRTIs|
12079436|NCT00052104|Behavioral|Cognitive-Behavioral Family Systems Intervention|
12079437|NCT00052091|Behavioral|Problem Solving Therapy|A 12 week cognitive behavioral intervention for depression that teaches patients a structured approach to solving social problems.
12079438|NCT00052091|Behavioral|Brief Supportive Therapy|A 12 week intervention for depression that focuses on supporting patients attempts to cope with depression.
12079439|NCT00052078|Drug|Sertraline (SRT)|Participants were treated with sertraline.
12079440|NCT00052078|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants received CBT.
12079441|NCT00052078|Drug|Placebo|Participants were treated with a placebo pill.
12079442|NCT00052065|Drug|TLK286|
12079443|NCT00052052|Drug|interferon-gamma 1b|200 mcg, SQ, 3x per week
12079444|NCT00052026|Drug|carvedilol|low-dose carvedilol administered twice daily for 8 months
12079445|NCT00052026|Drug|placebo|administered twice daily for 8 months
12079446|NCT00052026|Drug|carvedilol|high-dose carvedilol administered twice daily for 8 months
12079447|NCT00052039|Drug|interferon-gamma 1b|This study was terminated prior to enrollment.
12079448|NCT00052039|Drug|azathioprine|This study was terminated prior to enrollment.
12079449|NCT00052013|Drug|PTK787/ZK 222584|
12079450|NCT00052000|Drug|MLN2704 (DM1 conjugated monoclonal antibody MLN591)|
12079451|NCT00051987|Drug|VELCADE TM (bortezomib) for Injection, or PS-341|
12079452|NCT00051974|Drug|VELCADE™ (bortezomib) for Injection (formerly PS-341)|
12079453|NCT00051948|Drug|TLK286|
12079454|NCT00051935|Drug|Alglucosidase alfa|20 mg/kg (qow); intravenous
12079455|NCT00051922|Biological|PolyEnv1|Recombinant vaccinia virus vaccine
12079456|NCT00051909|Drug|LY451395|
12079457|NCT00051896|Drug|GBR 12909|
12079458|NCT00051844|Drug|Capravirine|
12079459|NCT00051831|Drug|Emtricitabine|Will be administered as one 200-mg capsule orally daily
12079460|NCT00051831|Drug|Enfuvirtide|Will be administered as a 90-mg (1.0 mL) subcutaneous injection twice daily
12079461|NCT00051831|Drug|Ritonavir|Will be administered as one 100-mg capsule orally twice daily
12079462|NCT00051831|Drug|Saquinavir|Will be administered as five hard gel capsules orally twice daily
12079463|NCT00051831|Drug|Tenofovir disoproxil fumarate|Will be administered as one 300-mg tablet orally daily
12079464|NCT00051870|Device|Magstim Rapid Magnetic Stimulator|
12079465|NCT00051805|Behavioral|Promotion of adherence to ARV medications|
12079466|NCT00051792|Behavioral|yoga|
12079467|NCT00051779|Drug|CAL|
12079468|NCT00051766|Behavioral|Computer-based Intervention|
12079469|NCT00051753|Drug|levofloxacin; amoxicillin/clavulanate|
12079470|NCT00051740|Behavioral|Cognitive Adaptation Therapy (CAT)|
12079471|NCT00051740|Behavioral|Minimal Environmental Supports (MES)|
12079472|NCT00051727|Behavioral|Bridges to High School Project|
12079473|NCT00051701|Drug|alemtuzumab|
12079474|NCT00051688|Drug|tezacitabine|
12079475|NCT00051688|Drug|oxaliplatin|
12079476|NCT00051675|Drug|ING-1(heMAb)|
12079477|NCT00051662|Drug|efalizumab|
12079478|NCT00051636|Drug|Zoledronic Acid|Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
12079479|NCT00051636|Drug|Risedronate|Oral risedronate 30 mg capsules.
12079480|NCT00051636|Drug|Placebo to Risedronate|Oral placebo of risedronate capsules.
12079481|NCT00051636|Drug|Placebo to Zoledronic Acid|5 mL of sterile water one dose intravenous infusion.
12079482|NCT00051636|Dietary Supplement|Calcium and Vitamin D|Calcium and vitamin D supplements were supplied.
12079483|NCT00051623|Drug|Infliximab|
12079484|NCT00051597|Drug|SGN-30 (monoclonal antibody)|
12079485|NCT00051584|Drug|SGN-15 (cBR96-Doxorubicin Immunoconjugate)|
12079486|NCT00051584|Drug|Gemzar (Gemcitabine)|
12079487|NCT00051571|Drug|SGN-15|
12079488|NCT00051571|Drug|Docetaxel|
12079489|NCT00051428|Procedure|Reiki (distant and direct-contact)|
12079490|NCT00051415|Behavioral|Flaxseed-supplemented diet|
12079491|NCT00051402|Drug|Isoflavones|
12079492|NCT00051558|Drug|Teriparatide|20 micrograms/day, injection, 36 months
12079493|NCT00051558|Drug|Alendronate Sodium|10 mg/day, oral, 36 months
12079494|NCT00051558|Drug|Placebo|Oral placebo, daily, 36 months
12079495|NCT00051558|Drug|Placebo|Injection placebo, daily, 36 months
12079496|NCT00051545|Drug|Seocalcitol|
12079497|NCT00051532|Drug|Seocalcitol|
12079498|NCT00051506|Drug|ALIMTA|
12079499|NCT00051506|Drug|carboplatin|
12079500|NCT00051506|Drug|cisplatin|
12079501|NCT00051493|Drug|ALIMTA|
12079502|NCT00051493|Drug|Carboplatin|
12079503|NCT00051480|Genetic|TNFerade|
12079504|NCT00051467|Genetic|TNFerade|
12079505|NCT00051454|Biological|HIV DNA plasmid vaccine plus recombinant fowlpox vector|
12079506|NCT00051441|Drug|Benzydamine Hydrochloride 0.15% Oral Rinse|
12079507|NCT00051389|Drug|Fosinopril|
12079508|NCT00051376|Drug|L-Arginine|
12079509|NCT00051363|Device|Active CPAP|Nightly nasal continuous positive airway pressure (CPAP)
12079510|NCT00051363|Device|Sham CPAP|Sham CPAP machine will be used for participants in the placebo group.
12079511|NCT00051350|Other|CARB|
12079512|NCT00051298|Drug|Olanzapine|
12079513|NCT00051298|Drug|Placebo|
12079514|NCT00051285|Drug|Enoximone|Participants receive oral enoximone
12079515|NCT00051285|Drug|Enoximone placebo|Participants receive placebo to match enoximone
12079516|NCT00051311|Procedure|Stem cell transplantation|
12079517|NCT00051272|Drug|Extended-release Bupropion Hydrochloride|
12079518|NCT00051259|Drug|Extended-Release Bupropion Hydrochloride|
12079519|NCT00051246|Behavioral|Mother-Infant Group Psychotherapy|Mother-infant group psychotherapy consists of weekly 2.5-hour psychotherapy sessions comprised of mother's group therapy, infant developmental therapy, and mother-infant dyadic psychotherapy. Group treatment will last 15 weeks.
12079520|NCT00051246|Behavioral|Interpersonal Psychotherapy|Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.
12079521|NCT00051233|Procedure|World Wide Web-Based Psychoeducation|
12079522|NCT00051220|Behavioral|One-Session Treatment for Specific Phobias|
12079523|NCT00051207|Behavioral|Interpersonal Psychotherapy (IPT)|
12079524|NCT00051207|Behavioral|IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)|
12079525|NCT00051194|Drug|Combination IOP Lowering Therapy|
12079526|NCT00051181|Drug|Travoprost (0.004%)|
12079527|NCT00051181|Drug|Latanoprost (0.005%)|
12079528|NCT00051168|Drug|Travatan|Travoprost (0.004%) 1 drop each eye once daily
12079529|NCT00051155|Drug|Travoprost (0.004%)|
12079530|NCT00051155|Drug|Latanoprost (0.005%)/Timolol (0.5%)|
12079531|NCT00051142|Drug|Travoprost|
12079532|NCT00051142|Drug|Latanoprost|
12079533|NCT00051129|Drug|Anecortave Acetate 15 mg sterile suspension|0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection
12079534|NCT00051129|Other|Anecortave Acetate Vehicle|Administered as a posterior juxtascleral injection
12079535|NCT00051116|Drug|CC-5013|
12079536|NCT00051103|Drug|Investigational Cancer Drug|
12079537|NCT00051090|Drug|Telbivudine|Administered orally at a daily dosage of 600 mg for a period of 48 weeks
12079538|NCT00051090|Drug|Lamivudine|Administered orally at a total daily dosage of 300 mg for Weeks 24-48
12079539|NCT00051090|Drug|Efavirenz|Administered orally at a daily dose of 600 mg
12079540|NCT00051090|Drug|Didanosine|Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weight
12079541|NCT00051090|Drug|Abacavir|Administered orally twice daily in doses of 300 mg
12079542|NCT00051077|Drug|Adefovir dipivoxil|
12079543|NCT00051077|Drug|Peginterferon-alfa-2A|
12079544|NCT00051077|Drug|Ribavirin|
12079545|NCT00051077|Procedure|Liver Biopsy|
12079546|NCT00051051|Drug|CI-1033|
12079547|NCT00051038|Drug|Entecavir|
12079548|NCT00051025|Drug|ONTAK|
12079549|NCT00051012|Drug|ONTAK|
12079550|NCT00050999|Drug|ONTAK|
12079551|NCT00050986|Drug|Temozolomide|Starting Dose Level: 100 mg/m^2 taken by mouth once daily for 7 days, followed by 7 days rest and another 7-day dosing period and 7-day rest period.
12079552|NCT00050986|Drug|R115777|Starting Dose Level: 400 mg taken by mouth for 7 consecutive days every other week on alternating weeks (days 8-14 and 22-28) every 4 weeks.
12079553|NCT00050973|Drug|bexarotene|
12079554|NCT00050960|Drug|bexarotene with carboplatin and paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
12079555|NCT00050960|Drug|carboplatin and paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
12079556|NCT00050947|Drug|oxcarbazepine|
12079557|NCT00050934|Drug|oxcarbazepine|
12079558|NCT00050921|Drug|somatropin|
12079559|NCT00050921|Biological|Hepatitis A virus, inactivated|
12079560|NCT00050921|Drug|Keyhole-Limpet Hemocyanin|
12079561|NCT00050895|Drug|Lopinavir/ritonavir|
12079562|NCT00050895|Drug|Efavirenz|
12079563|NCT00050895|Drug|Stavudine|
12079564|NCT00050895|Drug|Zidovudine|
12079565|NCT00050895|Drug|Lamivudine|
12079566|NCT00050895|Drug|Tenofovir disoproxil fumarate|
12079567|NCT00050882|Drug|GM-611|
12079568|NCT00050856|Drug|Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor|
12079569|NCT00050843|Drug|thalidomide|
12079570|NCT00050830|Drug|CI 1033|
12079571|NCT00050817|Drug|clopidogrel (SR25990)|
12079572|NCT00050791|Drug|Leptin|Leptin is an adipocyte hormone that functions as an afferent signal in a feedback loop regulating body weight
12079573|NCT00050791|Behavioral|Very Low Calorie Diet|placebo injections
12079574|NCT00050778|Biological|Interferon beta-1a|Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 36 months.
12079575|NCT00050778|Biological|Alemtuzumab 12 mg|Alemtuzumab 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the cluster of differentiation 4+ [CD4+] T-cell count was >=100*10^6 cells per liter).
12079576|NCT00050778|Biological|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
12079577|NCT00050804|Drug|sertraline|
12079578|NCT00050765|Drug|MyoCell™ Autologous Myoblasts|
12079579|NCT00050687|Drug|Gallium maltolate|
12079580|NCT00050726|Drug|Interleukin-2|
12079581|NCT00050713|Drug|Sirolimus|
12079582|NCT00050674|Drug|Filgrastim-SD/01|6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)
12079583|NCT00050661|Drug|Daclizumab|Humanized anti-CD25 antibodies (anti-TAC), or placebo (saline solution), will be given as intravenous infusions on the following schedule: 2 mg/kg initially (maximum dose 200 mg) infusion given over 60 minutes, followed by a 1 mg/kg (maximum of 100 mg) infusion given over 30 minutes every two weeks thereafter for a total of 8 doses.
12079584|NCT00050661|Device|NB-UVB|total body NB-UVB at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until for a total of 20 ± 2 treatments total.
12079585|NCT00050648|Drug|Daclizumab|1mg/kg medication every other week on the odd week (week 1-13).
12079586|NCT00050648|Drug|Cyclosporine|2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks.
12079587|NCT00050648|Drug|cyclosporine and Daclizumab|1mg/kg plus low dose cyclosporine (2 mg/kg/day)
12079588|NCT00050635|Drug|Sandostatin LAR Depot|
12079589|NCT00050609|Drug|tadalafil|5 mg tadalafil tablet taken by mouth once a day for 8 weeks
12079590|NCT00050609|Drug|tadalafil|20 mg tadalafil tablet taken by mouth once a day for 8 weeks
12079591|NCT00050609|Drug|placebo|Placebo tablet taken by mouth once a day for 8 weeks
12079592|NCT00050427|Drug|ET743|580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
12079593|NCT00050427|Drug|ET743|1,300 mcg/m2, 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
12079594|NCT00050622|Drug|Methylphenidate 0.15 mg/kg|0.15 m/kg/dose immediate-release methylphenidate
12079595|NCT00050622|Behavioral|Low-Intensity BMOD|Lower-intensity behavioral treatment package.
12079596|NCT00050622|Drug|Methylphenidate 0.3 mg/kg|0.3 mg/kg/dose immediate-release methylphenidate
12079597|NCT00050622|Drug|Placebo|
12079598|NCT00050622|Drug|Methylphenidate 0.6 mg/kg|0.3 mg/kg/dose immediate-release methylphenidate
12079599|NCT00050622|Behavioral|High Intensity BMOD|Comprehensive high-intensity Summer Treatment Program (STP)
12079600|NCT00050596|Drug|MDX-010 / MDX-010 + Docetaxel|
12079601|NCT00050583|Behavioral|Cognitive Behavioral Therapy|Ten Weekly Sessions of Manualized CBT
12079602|NCT00050583|Behavioral|CBT|Cognitive Behavioral Therapy
12079603|NCT00050570|Behavioral|Web-based intervention to reduce eating disorder risk factors|
12079604|NCT00050557|Behavioral|Multifamily Psychoeducation Group (MFPG)|MFPG will include 8 weekly 90-minute group therapy sessions.
12079605|NCT00050557|Behavioral|Treatment as usual (TAU)|Participants will receive standard care for mood disorders.
12079606|NCT00050518|Biological|Aventis Pasteur Smallpox Vaccine|
12079607|NCT00050505|Biological|Live vaccinia virus vaccine|Dryvax undiluted. Cohort A receives undiluted dose of Dryvax vaccine
12079608|NCT00050505|Biological|Live vaccinia virus vaccine|Dryvax with diluent (50% glycerin and 0.25% phenol in sterile water). Cohort A-C receives diluted dose of Dryvax vaccine.
12079609|NCT00050479|Drug|Celecoxib (Celebrex)|
12079610|NCT00050440|Drug|Trabectedin|Trabectedin 1.3 mg/m2 administered intravenously every 21 days.
12079611|NCT00050440|Drug|Dexamethasone|Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose
12079612|NCT00050414|Drug|Trabectedin|Trabectedin 0.58 mg/m2, administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression.
12079613|NCT00050414|Drug|Dexamethasone|Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
12079614|NCT00050401|Drug|MERREM I.V. 2g as a 3 hour infusion every 8 hours|
12079615|NCT00050401|Drug|vancomycin I.V. 1 g every 12 hours|
12079616|NCT00050401|Drug|tobramycin I.V. 5 mg/kg every 24 hours|
12079617|NCT00050401|Drug|MERREM I.V. 1g as a 30 minute infusion every 8 hours|
12079618|NCT00050401|Drug|MERREM I.V. 500 mg as a 3 hour infusion every 8 hours|
12079619|NCT00011635|Drug|Silymarin (milk thistle)|
12079620|NCT00011063|Drug|Ginkgo Biloba|
12079621|NCT00009542|Drug|kava (Piper methysticum)|
12079622|NCT00006395|Drug|St. John's Wort|
12079623|NCT00006155|Drug|SU5416 and carboplatin|
12079624|NCT00006062|Drug|oxaliplatin|
12079625|NCT00005926|Drug|Gemcitabine|
12079626|NCT00005926|Drug|Herceptin|
12079627|NCT00005926|Procedure|Radiation therapy|
12079628|NCT00005912|Drug|Voriconazole|
12079629|NCT00005783|Drug|Recombinant-methionyl human stem cell factor|
12079630|NCT00005574|Drug|Gentamicin|
12079631|NCT00004576|Drug|LY300164|
12079632|NCT00001986|Drug|1-Octanol|
12079633|NCT00001968|Drug|Amprenavir|
12079634|NCT00001968|Drug|Ritonavir|
12079635|NCT00001968|Drug|Abacavir|
12079636|NCT00001968|Drug|Lamivudine|
12079637|NCT00001966|Drug|Mind-body therapy|
12079638|NCT00001965|Drug|Cyclosporine A|
12079639|NCT00001963|Procedure|hemoglobin-transported nitric oxide|
12079640|NCT00001944|Drug|Vinorelbine|
12079641|NCT00001944|Drug|XR9576|
12079642|NCT00001940|Drug|Voriconazole|
12079643|NCT00001937|Drug|FK463|
12079644|NCT00001937|Drug|Fluconazole|
12079645|NCT00001931|Drug|N-0923|
12079646|NCT00001930|Drug|Amantadine|
12079647|NCT00001929|Drug|Eliprodil|
12079648|NCT00001909|Drug|Soluble recombinantly produced IL-4R|
12079649|NCT00001906|Biological|Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants|
12079650|NCT00001903|Drug|RSV Polyclonal Immunoglobulin|
12079651|NCT00001891|Procedure|Myocardial contrast echocardiography|
12079652|NCT00001891|Procedure|Dobutamine echocardiography|
12079653|NCT00001890|Drug|Estrogen therapy|
12079654|NCT00001889|Procedure|Myocardial contrast echocardiography|
12079655|NCT00001889|Procedure|Stress echocardiography with dobutamine|
12079656|NCT00001886|Procedure|Real time 3-dimensional stress echocardiography|
12079657|NCT00001857|Drug|BG9588|
12079658|NCT00001839|Drug|Antithymocyte globulin|
12079659|NCT00001839|Drug|Cyclosporine|
12079660|NCT00001812|Drug|Nystatin|
12079661|NCT00001810|Drug|Voriconazole|
12079662|NCT00001805|Drug|Rituximab|
12079663|NCT00001797|Drug|Recombinant human interleukin-10|
12079664|NCT00001790|Drug|FK463|
12079665|NCT00001789|Drug|BG9588|
12079666|NCT00001777|Drug|Sertraline|
12079667|NCT00001768|Drug|Intravenous immunoglobulin|
12079668|NCT00001763|Drug|Interleukin-12|
12079669|NCT00001761|Drug|Interleukin-10|
12079670|NCT00001757|Drug|Voriconazole|
12079671|NCT00001753|Procedure|Magnetic resonance imaging|
12079672|NCT00001752|Drug|L-arginine|
12079673|NCT00001752|Drug|Estrogen|
12079674|NCT00001748|Procedure|Peripheral blood progenitor cell transplant|
12079675|NCT00001736|Drug|Cysteamine|
12079676|NCT00001735|Procedure|Gene therapy|
12079677|NCT00001731|Drug|Cyclosporin A|
12079678|NCT00001730|Drug|Thyrogen|
12079679|NCT00001718|Device|Electropalatography|
12079680|NCT00001705|Drug|GP100 peptide|
12079681|NCT00001705|Drug|IL-2|
12079682|NCT00001696|Drug|Genistein|
12079683|NCT00001685|Biological|Immunodominant peptides from three melanoma antigens, MART-1, GP100 and tyrosinase|
12079684|NCT00001680|Drug|Thalidomide|
12079685|NCT00001677|Drug|Methotrexate|
12079686|NCT00001677|Drug|Fludarabine|
12079687|NCT00001669|Drug|rhIGF-1 (CEP-151)|
12079688|NCT00001658|Drug|Amoxicillin|
12079689|NCT00001646|Drug|Voriconazole|
12079690|NCT00001646|Drug|Amphotericin B|
12079691|NCT00001633|Procedure|Coronary magnetic resonance angiography imaging|
12079692|NCT00001629|Drug|Angiotensin II type 1 receptor antagonists|
12079693|NCT00001628|Drug|Angiotensin II type 1 receptor antagonists|
12079694|NCT00001624|Drug|Insulin|
12079695|NCT00001622|Procedure|investigate the relationship between in vivo and in vitro vascular responses|
12079696|NCT00001615|Drug|Corticosteroid|
12079697|NCT00001614|Drug|Chicken type II collagen|
12079698|NCT00001605|Biological|Nontypeable Haemophilus influenzae|
12079699|NCT00001587|Procedure|Isolated hepatic portal and arterial perfusion|
12079700|NCT00001587|Drug|Melphalan|
12079701|NCT00001579|Drug|5-Fluorouracil|
12079702|NCT00001579|Drug|Ethynyluracil|
12079703|NCT00001579|Drug|Leucovorin|
12079704|NCT00001577|Procedure|double isolated limb perfusion with melphalan alone|
12079705|NCT00001573|Drug|SU101|
12079706|NCT00001570|Drug|PSC 833|
12079707|NCT00001570|Drug|vinblastine|
12079708|NCT00001565|Drug|phenylbutyrate|
12079709|NCT00001554|Device|intraoperative infrared (IR) neuroimaging|
12079710|NCT00001538|Biological|APL 400-003|
12079711|NCT00001533|Drug|cyclosporine|
12079712|NCT00001520|Drug|neostigmine|
12079713|NCT00001509|Drug|IFN-alpha with retinoic acid|
12079714|NCT00001502|Drug|RMP-7 and carboplatin|
12079715|NCT00001499|Drug|paclitaxel|
12079716|NCT00001499|Drug|cisplatin|
12079717|NCT00001499|Procedure|chest radiotherapy|
12079718|NCT00001498|Drug|methotrexate|
12079719|NCT00001498|Drug|leucovorin|
12079720|NCT00001498|Drug|5-fluorouracil|
12079721|NCT00001498|Drug|cyclophosphamide|
12079722|NCT00001498|Procedure|peripheral blood progenitor cell|
12079723|NCT00001498|Drug|paclitaxel|
12079724|NCT00001498|Drug|doxorubicin|
12079725|NCT00001495|Drug|irinotecan (CPT-11)|
12079726|NCT00001493|Genetic|peripheral blood progenitor cells carrying MDR1|
12079727|NCT00001482|Drug|Lamotrigine (Lamictal® (Registered Trademark)|
12079728|NCT00001482|Drug|Gabapentin (Neurontin® (Registered Trademark))|
12079729|NCT00001450|Drug|paclitaxel|
12079730|NCT00001450|Drug|cisplatin|
12079731|NCT00001449|Drug|gemcitabine|
12079732|NCT00001449|Drug|fluorodeoxyuridine|
12079733|NCT00001449|Drug|leucovorin|
12079734|NCT00001446|Drug|thalidomide|
12079735|NCT00001445|Biological|HIV-1 Immunogen|
12079736|NCT00001443|Drug|indinavir (MK-0639)|
12079737|NCT00001439|Biological|gp100 human melanoma peptide|
12079738|NCT00001438|Drug|all-trans-retinoic acid with IFN-alpha2a|
12079739|NCT00001437|Drug|pentoxifylline|
12079740|NCT00001436|Drug|OncoLAR® (Registered Trademark)|
12079741|NCT00001436|Drug|tamoxifen|
12079742|NCT00001431|Drug|gemcitabine|
12079743|NCT00001428|Drug|5-fluorouracil|
12079744|NCT00001427|Drug|9-aminocamptothecin|
12079745|NCT00001422|Drug|fludarabine|
12079746|NCT00001421|Drug|methimazole|
12079747|NCT00001416|Drug|CEREDASE™|
12079748|NCT00001402|Device|PET scan|
12079749|NCT00001387|Drug|paclitaxel|
12079750|NCT00001384|Drug|Adriamycin|
12079751|NCT00001384|Drug|cyclophosphamide|
12079752|NCT00001384|Drug|G-CSF|
12079753|NCT00001384|Drug|paclitaxel|
12079754|NCT00001383|Drug|PSC 833|
12079755|NCT00001383|Drug|paclitaxel|
12079756|NCT00001382|Biological|PROSTVAC|
12079757|NCT00001381|Drug|suramin|
12079758|NCT00001378|Drug|fenretinide|
12079759|NCT00001365|Drug|dextromethorphan|
12079760|NCT00001344|Drug|dextromethorphan|
12079761|NCT00001341|Drug|ZD1694 (TOMUDEX)|
12079762|NCT00001338|Drug|FLAC chemotherapy with GM-CSF|
12079763|NCT00001333|Drug|topotecan|
12079764|NCT00001332|Procedure|CHPP with cisplatin|
12079765|NCT00001318|Drug|interferon gamma|
12079766|NCT00001317|Drug|interferon-gamma|
12079767|NCT00001311|Device|heparin-surface modified intraocular lens|
12079768|NCT00001300|Drug|doxorubicin|
12079769|NCT00001300|Drug|ifosfamide|
12079770|NCT00001300|Drug|mesna|
12079771|NCT00001298|Drug|carboxypeptidase-G2|
12079772|NCT00001296|Drug|melphalan|
12079773|NCT00001296|Drug|tumor necrosis factor|
12079774|NCT00001296|Drug|interferon-gamma|
12079775|NCT00001296|Procedure|hyperthermic isolated limb perfusion|
12079776|NCT00001287|Drug|intravenous immunoglobulin (IVIg)|
12079777|NCT00001280|Drug|itraconazole|
12079778|NCT00001272|Drug|taxol|
12079779|NCT00001271|Drug|IgG-RFB4-SMPT-dgA|
12079780|NCT00001270|Drug|interleukin-1|
12079781|NCT00001269|Drug|IL-3|
12079782|NCT00001267|Drug|zidovudine|
12079783|NCT00001267|Drug|2',3'-dideoxyinosine|
12079784|NCT00001249|Drug|Yttrium-90 radiolabeled anti-Tac antibody|
12079785|NCT00001239|Drug|FLAC with GM-CSF|
12079786|NCT00001237|Drug|granulocyte-macrophage colony stimulating factor (GM-CSF)|
12079787|NCT00001217|Drug|pre-surgical chemotherapy|
12079788|NCT00001209|Drug|vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16|
12079789|NCT00001193|Procedure|high dose melphalan and autologous bone marrow transplantation|
12079790|NCT00001189|Procedure|radiotherapy|
12079791|NCT00001188|Procedure|radiation therapy following surgery|
12079792|NCT00050388|Genetic|Allovectin-7®|
12079793|NCT00050375|Drug|oregovomab|
12079794|NCT00050362|Drug|Rofecoxib and Bupivacaine|
12079795|NCT00050349|Drug|EPO906 epothilone B|
12079796|NCT00050336|Drug|Lonafarnib (SARASAR)|
12079797|NCT00050323|Drug|Allogeneic DCs and Autologous RCC Tumor Derived Cells|
12079798|NCT00050297|Drug|YM598|
12079799|NCT00050271|Drug|Acetyl-L-carnitine|
12079800|NCT00050245|Drug|Rituximab|
12079801|NCT00050232|Drug|AVP-923|
12079802|NCT00050141|Drug|ZARNESTRA, tipifarnib, R115777|
12079803|NCT00050206|Drug|Olanzapine|
12079804|NCT00050206|Drug|Placebo|
12079805|NCT00050167|Drug|Paclitaxel|80 mg/m^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks
12079806|NCT00050167|Drug|Docetaxel|75 mg/m^2 by vein (IV) Over 1 Hour Once Every 3 Weeks
12079807|NCT00050167|Drug|Capecitabine|1500 mg/m^2 by mouth Twice Daily x 2 Weeks
12079808|NCT00050180|Drug|Midazolam|
12079809|NCT00050180|Drug|Indinavir|
12079810|NCT00050180|Drug|Saquinavir|
12079811|NCT00050154|Drug|ZARNESTRA, tipifarnib, R115777|
12079812|NCT00050128|Device|rTMS, Magstim|
12079813|NCT00050102|Drug|MDX-010 (CTLA-4)|
12079814|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
12079815|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
12079816|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
12079817|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
12079818|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
12079819|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
12079820|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
12079821|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
12079822|NCT00050076|Drug|MCC-135|MCC-135 50 mg, tablets, orally, twice daily for up to 12 weeks
12079823|NCT00050076|Drug|MCC-135|MCC-135 100 mg, tablets, orally, once daily for up to 12 weeks
12079824|NCT00050076|Drug|MCC-135|MCC-135 200 mg, tablets, orally, once daily for up to 12 weeks
12079825|NCT00050076|Drug|Placebo|MCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks
12079826|NCT00050063|Biological|Therapeutic vaccinations from A5058s|Participants will receive assigned interventions assigned in study A5058s.
12079827|NCT00050050|Behavioral|Cognitive behavioral therapy|
12079828|NCT00050050|Drug|Drug therapy|
12079829|NCT00050037|Procedure|CBT|
12079830|NCT00050011|Drug|Zoledronic Acid|Participants received Zoledronate 4 mg IV 15-minute infusion every 6 months.
12079831|NCT00050011|Drug|Letrozole|Participants received Letrozole 2.5 mg daily.
12079832|NCT00049998|Drug|topotecan|
12079833|NCT00049985|Drug|Darbepoetin Alfa|
12079834|NCT00049972|Drug|paroxetine CR|
12079835|NCT00049959|Drug|verteporfin PDT|
12079836|NCT00049946|Drug|talnetant|
12079837|NCT00049946|Drug|risperidone|
12079838|NCT00049842|Biological|peginterferon alfa-2b (SCH 54031)|0.5 µg/kg Weekly QW SC for 36 months
12079839|NCT00049829|Drug|Zoledronic Acid|
12079840|NCT00049816|Behavioral|Walking exercise|30 minutes/day, 3 times/week for 52 weeks
12079841|NCT00049816|Behavioral|Cycling Exercise|30 minutes/day, 3 times/week for 52 weeks
12079842|NCT00049803|Drug|sodium oxybate|
12079843|NCT00049790|Drug|recombinant human Angiostatin protein|
12079844|NCT00049790|Drug|paclitaxel|
12079845|NCT00049790|Drug|carboplatin|
12079846|NCT00049777|Drug|Drotrecogin Alfa (Activated)|
12079847|NCT00049777|Drug|Unfractionated heparin|
12079848|NCT00049777|Drug|Low molecular weight heparin|
12079849|NCT00049764|Drug|Drotrecogin alfa (activated)|
12079850|NCT00049764|Drug|Placebo|
12079851|NCT00049751|Drug|Adalimumab|
12079852|NCT00048945|Drug|PEGASYS|
12079853|NCT00049725|Drug|Daclizumab|
12079854|NCT00048932|Drug|Double-blind Abatacept|Concentrate and diluted in a solution, IV, 500 mg (body weight < 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight > 100 Kg), Once daily, Day 1, 15, and 29.
12079855|NCT00048932|Drug|Double-blind Placebo|Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.
12079856|NCT00048932|Drug|Open-label Abatacept|Concentrate and diluted in a solution, IV, 500 mg (body weight < 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight > 100 Kg), Once daily, Every 28 days.
12079857|NCT00048854|Drug|Sertraline|Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.
12079858|NCT00048854|Other|Treatment as usual (TAU)|At the TAU baseline visit, patients will be told of their diagnosis of PMS/PMDD. Those patients who decide to seek treatment outside of the study protocol or do not wish to seek treatment will be asked to participate in the TAU part of this protocol. Patients in TAU will be contacted monthly to obtain monthly information about how they have been feeling (blinded ratings) using the study measures.
12079859|NCT00048841|Drug|alendronate|
12079860|NCT00048828|Drug|Olanzapine|Participants will receive olanzapine for 12 weeks.
12079861|NCT00048828|Drug|Clozapine|Participants will receive 12 weeks of clozapine.
12079862|NCT00048815|Drug|Citalopram|Established Selective Serotonin Reuptake Inhibitor antidepressant
12079863|NCT00048815|Drug|St. John's Wort|Natural extract from the St. John's Wort plant.
12079864|NCT00048815|Drug|Placebos|Placebo pill
12079865|NCT00048802|Drug|Lithium|
12079866|NCT00048802|Drug|Olanzapine|
12079867|NCT00048802|Drug|Divalproex|
12079868|NCT00048802|Drug|Risperidone|
12079869|NCT00048802|Drug|Quetiapine|
12079870|NCT00048802|Drug|Ziprasidone|
12079871|NCT00048802|Drug|Aripriprazole|
12079872|NCT00048581|Drug|Abatacept|Vials, intravenous (IV), ~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
12079873|NCT00048581|Drug|Placebo|Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
12079874|NCT00048581|Drug|Abatacept|Vials, IV, ~10mg/kg abatacept, every 4 weeks, 5.5 years
12079875|NCT00048568|Drug|Abatacept|Intravenous (IV) Solution, - Weight Titered (500 mg < 60 kg); (750 mg 60-100 kg), )1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
12079876|NCT00048568|Drug|Methotrexate|Tablets, Oral, >= 15 mg, weekly, 1 year
12079877|NCT00048568|Drug|Placebo|IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
12079878|NCT00048906|Drug|DRX005B|
12079879|NCT00048893|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|4 x 10^8 pfu given monthly subcutaneously for three doses in the first series and three doses on each of the intermediate and late re-immunizations (total 9 doses).
12079880|NCT00048893|Biological|recombinant vaccinia-CEA(6D)/TRICOM vaccine|rV-CEA (6D)/Tricom concomitantly with sargramostim (rGM-CSF). 1.2 x 10^8 pfu x 1 dose subcutaneously.
12079881|NCT00048893|Biological|filgrastim|5 mcg/kg/day subcutaneously
12079882|NCT00048893|Biological|sargramostim|100 mcg daily for 4 consecutive days at the same site as the rF-CEA (6D)/Tricom vaccine. The first dose will be given with the vaccine.
12079883|NCT00048893|Drug|cyclophosphamide|"First induction chemotherapy: 2700 mg/m^2 per cycle (900 mg/m^2 per day intravenous over 1 hour for 3 consecutive days, days 1-3).
~Second induction: 600 mg/m^2 per cycle (600 mg/m^2 intravenous over 1 hour day 1.
~Immune depleting chemotherapy: 2400 mg/m^2 per cycle (600 mg/m^2 per day intravenous over 1 hour for 4 consecutive days, days 1-4)."
12079884|NCT00048893|Drug|doxorubicin hydrochloride|60 mg/m^2 per cycle (60 mg/m^2 slow intravenous push day 1).
12079885|NCT00048893|Drug|fludarabine phosphate|120 mg/m^2 (30 mg/m^2 per day intravenous over 30 minutes for 4 consecutive days (days 1-4)).
12079886|NCT00048893|Drug|paclitaxel|160 mg/m^2 per cycle (53.3 mg/m^2 per day by continuous intravenous infusion over 24 hours for 3 consecutive days 1-3).
12079887|NCT00048893|Drug|Mesna|"Percent equals fraction of total daily cyclophosphamide dose. Initial: 20% of cyclophosphamide dose given intravenously (IV) mixed with cyclophosphamide.
~3 hours post completion of cyclophosphamide: 20% intravenously (IV) or 40% by mouth (PO) 6 hours post completion of cyclophosphamide: 20% intravenously (IV) or 40% by mouth (PO) 9 hours post completion of cyclophosphamide: 20% intravenously (IV) or 40% by mouth (PO)"
12079888|NCT00048880|Drug|HeFi-1 Monoclonal Antibody|
12079889|NCT00048776|Drug|Pletal|
12079890|NCT00048763|Drug|Pletal|
12079891|NCT00048789|Procedure|Extracorporeal Photopheresis|
12079892|NCT00048750|Drug|Micafungin|IV
12079893|NCT00048750|Drug|Placebo|IV
12079894|NCT00048737|Drug|Zevalin Radioimmunotherapy|Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
12079895|NCT00048737|Drug|Rituximab|250 mg/m^2 on day 1 and day 8
12079896|NCT00048737|Drug|Fludarabine|30 mg/m^2/day for 3 days
12079897|NCT00048737|Drug|Cyclophosphamide|750 mg/m^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals
12079898|NCT00048737|Procedure|Allogeneic Stem Cell Transplantation|Allogeneic stem cell transplantation 2 days after chemotherapy
12079899|NCT00048724|Biological|peginterferon alfa-2b (SCH 54031)|0.5 µg/kg subcutaneously once weekly for 60 months
12079900|NCT00048711|Drug|N-acetylgalactosamine 4-sulfatase|
12079901|NCT00048698|Procedure|TMS|
12079902|NCT00048698|Procedure|EEG|
12079903|NCT00048672|Drug|Gleevec|Starting dose of 400 mg orally daily.
12079904|NCT00048659|Drug|YM598|
12079905|NCT00048646|Drug|IV Progesterone|
12079906|NCT00048633|Drug|Chemotherapy|
12079907|NCT00048620|Drug|N-acetylgalactosamine 4-sulfatase|
12079908|NCT00048607|Drug|aprepitant|
12079909|NCT00048607|Drug|Comparator: paroxetine HCL|
12079910|NCT00048607|Drug|Comparator: Placebo (Unspecified)|
12079911|NCT00048594|Drug|aprepitant|
12079912|NCT00048594|Drug|Comparator: placebo (unspecified)|
12079913|NCT00048555|Drug|IDEC-114|Dose Group 1 - 125 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions
12079914|NCT00048542|Biological|Double-Blind Adalimumab/Placebo + MTX|Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg.
12079915|NCT00048542|Biological|Double-Blind Adalimumab/Placebo|Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg.
12079916|NCT00048542|Drug|OLE BSA Adalimumab +/- MTX|Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase.
12079917|NCT00048542|Drug|OLE FD Adalimumab +/- MTX|Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase.
12079918|NCT00048529|Drug|T900607-sodium intravenous|
12079919|NCT00048516|Drug|paricalcitol capsule|
12079920|NCT00048503|Drug|ZARNESTRA, tipifarnib, R115777|
12079921|NCT00048464|Procedure|Infusion of Activated & Expanded Autologous T Cells|
12079922|NCT00048451|Drug|paricalcitol|
12079923|NCT00048438|Drug|paricalcitol|
12079924|NCT00048425|Drug|Levosimendan|
12079925|NCT00048490|Device|transcranial magnetic stimulation (TMS)|
12079926|NCT00048477|Drug|L-NMMA and Sodium Nitrite|
12079927|NCT00048412|Drug|FLUDARABINE|
12079928|NCT00048412|Drug|CAMPATH 1H|
12079929|NCT00048412|Drug|FK50|
12079930|NCT00048412|Procedure|Stem Cell Collection and Infusion|
12079931|NCT00048399|Drug|Fludarabine|
12079932|NCT00048399|Drug|CAMPATH 1H|
12079933|NCT00048399|Drug|FK506|
12079934|NCT00048399|Procedure|Stem Cell Transplantation|
12079935|NCT00048386|Biological|autologous neuroblastoma vaccine|A vaccine dose of 0.3 x 108 IL-2 secreting cells/patient/injection will be used. Injections will be given twice monthly for two months, then monthly for four months, for a total of eight vaccine injections over six months.
12079936|NCT00048373|Drug|Etanercept|
12079937|NCT00048360|Drug|Extended-release bupropion hydrochloride|
12079938|NCT00048321|Drug|ISIS 104838|
12079939|NCT00048308|Drug|pexelizumab|
12079940|NCT00048347|Drug|AVONEX|30µg IM every week for 12 weeks
12079941|NCT00048334|Drug|Depsipeptide, FR901228, FK228|
12079942|NCT00048295|Drug|Alicaforsen|
12079943|NCT00048230|Drug|bortezomib|
12079944|NCT00048217|Drug|T-1249|
12079945|NCT00048204|Drug|GW597599B|
12079946|NCT00048204|Drug|paroxetine|
12079947|NCT00048165|Drug|Daclizumab|Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.
12079948|NCT00048165|Drug|Methylprednisolone|Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days).
12079949|NCT00048165|Drug|Mycophenolate mofetil|Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.
12079950|NCT00048165|Drug|Placebo|Matching placebo will be administered on Days 1, 8, 22, 36, and 50.
12079951|NCT00048165|Drug|cyclosporine|Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.
12079952|NCT00048152|Drug|Corticosteroids|As prescribed
12079953|NCT00048152|Drug|Neoral|Low dose (target trough level 50-100ng/mL)
12079954|NCT00048152|Drug|Neoral|Standard dose (target trough level 150-300ng/mL)
12079955|NCT00048152|Drug|Zenapax|2mg/kg iv first dose, then 1mg/kg every 2 weeks
12079956|NCT00048152|Drug|mycophenolate mofetil [CellCept]|1g po bid
12079957|NCT00048139|Drug|Irinotecan|250mg/m2 iv on day 1 of each 3 week cycle
12079958|NCT00048139|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-15 of each 3 week cycle
12079959|NCT00048126|Drug|Irinotecan|100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.
12079960|NCT00048126|Drug|capecitabine [Xeloda]|1000mg po bid
12079961|NCT00048113|Drug|Alicaforsen|
12079962|NCT00048100|Procedure|Apheresis|Apheresis for T-Cell collection
12079963|NCT00048100|Biological|Stem Cell Transplant|Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
12079964|NCT00048087|Drug|ZD1839|250 mg by mouth daily each day for 4 weeks.
12079965|NCT00048087|Drug|Docetaxel|30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.
12079966|NCT00048074|Drug|ibandronate [Bonviva/Boniva]|2mg iv every 2 months
12079967|NCT00048074|Drug|ibandronate [Bonviva/Boniva]|2.5mg po daily
12079968|NCT00048074|Drug|ibandronate [Bonviva/Boniva]|3mg iv every 3 months
12079969|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|2.5mg po daily
12079970|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|100mg po monthly on a single day
12079971|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|100mg po monthly over 2 consecutive days
12079972|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|150mg po monthly
12079973|NCT00048061|Dietary Supplement|Calcium|500 mg/day
12079974|NCT00048061|Dietary Supplement|Vitamin D|400 IU/day
12079975|NCT00048048|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Differing doses and frequencies of sc administration
12079976|NCT00048035|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Differing doses and frequencies of iv administration
12079977|NCT00048022|Drug|Dual Integrin Antagonist|
12079978|NCT00048009|Drug|Dual Integrin Antagonist|
12079979|NCT00047983|Dietary Supplement|Canola oil|
12079980|NCT00047983|Dietary Supplement|Arginine|
12079981|NCT00047983|Dietary Supplement|Fish oil emulsion|
12079982|NCT00047840|Drug|ZD6474|
12079983|NCT00047840|Drug|Placebo|
12079984|NCT00047840|Drug|Docetaxel|
12079985|NCT00047827|Drug|Micafungin|IV
12079986|NCT00047827|Drug|Liposomal Amphotericin B|IV
12079987|NCT00047814|Drug|FK788|
12079988|NCT00047931|Drug|VRC-HIVDNA009-00-VP|
12079989|NCT00047905|Behavioral|examine the process of prenatal genetic counseling|
12079990|NCT00047879|Biological|PEG-interferon alfa-2b|0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection
12079991|NCT00047879|Drug|Thalidomide|Two 50mg tablets (100 mg total dose) every night before bedtime starting on day one.
12079992|NCT00047853|Device|Shock device|Electric shock stimulus
12079993|NCT00047853|Device|Acoustic startle|Acoustic startle for MEG only
12079994|NCT00047801|Drug|TLK286 in combination with docetaxel|
12079995|NCT00047788|Drug|ZD6474|
12079996|NCT00047788|Drug|VEGF-receptor tyrosine kinase (KDR)|
12079997|NCT00047775|Drug|BiDil|
12079998|NCT00047762|Drug|Erlotinib (aka Tarceva or OSI-774)|
12079999|NCT00047762|Drug|Bevacizumab (aka Avastin or Rhu MAb VEGF)|
12080000|NCT00047554|Drug|Travoprost, 0.004% ophthalmic solution|
12080001|NCT00047541|Drug|Alcon Investigational Agent|
12080002|NCT00047528|Drug|Alcon Investigational Agent|
12080003|NCT00047515|Drug|Alcon Investigational Agent|
12080004|NCT00047749|Drug|Prialt (ziconotide)|
12080005|NCT00047736|Drug|Tarceva (erlotinib HCl)|
12080006|NCT00047723|Drug|minocycline|
12080007|NCT00047710|Drug|Bevacizumab|Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
12080008|NCT00047710|Drug|Capecitabine|650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
12080009|NCT00047710|Radiation|Radiotherapy|Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
12080010|NCT00047697|Drug|Donepezil HCl|Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
12080011|NCT00047697|Drug|Placebo|Placebo used in placed of Donepezil HCL
12080012|NCT00047684|Behavioral|Brief Integrative Therapy|
12080013|NCT00047671|Drug|Citalopram|PDA Approved antidepressant
12080014|NCT00047658|Drug|Interferon-gamma 1b|200 mcg, SQ, 3x per week
12080015|NCT00047645|Drug|Interferon-gamma 1b|200 mcg, SQ, 3x per week
12080016|NCT00047632|Drug|Interferon gamma-1b|100 mcg, SQ, 3x per week
12080017|NCT00047606|Drug|IOP Lowering Medications|
12080018|NCT00047593|Drug|IOP Lowering Medications|
12080019|NCT00047619|Procedure|Pulsatile Lavage|pulsatile lavage to wound bed
12080020|NCT00047619|Other|sham pulsatile lavage|pulsatile lavage to not directed at wound or patient
12080021|NCT00047580|Drug|tizanidine hydrochloride capsule|
12080022|NCT00047567|Drug|zonisamide|
12080023|NCT00046371|Drug|THERATOPE® vaccine|
12080024|NCT00047502|Drug|Lonafarnib (SCH66336)|"Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.
~Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.
~Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day."
12080025|NCT00047502|Drug|Imatinib Mesylate (Gleevec)|"Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day.
~Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day."
12080026|NCT00047489|Drug|ABT-751|
12080027|NCT00047476|Drug|dexmethylphenidate(d-mph)|
12080028|NCT00047463|Device|continuous positive airway pressure (CPAP)|a mask treatment for sleep apnea
12080029|NCT00047463|Device|Placebo-CPAP|Placebo-CPAP
12080030|NCT00047450|Drug|Citalopram (Celexa)|Citalopram for 3 months
12080031|NCT00047450|Drug|Placebo|Placebo for 3 months
12080032|NCT00047437|Behavioral|Supervised Exercise Training Program|Exercise 30 minutes minimum three times per week.
12080033|NCT00047411|Other|Cardiopulmonary Resuscitation|Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines
12080034|NCT00047411|Device|Automatic External Defibrillation|Use the AED first, in accordance with published guidelines for AED use, followed by a call to EMS and perform CPR as in the control group.
12080035|NCT00046800|Drug|OSI-211 (Liposomal Lurtotecan)|
12080036|NCT00046787|Drug|OSI-211 (Liposomal Lurtotecan)|
12080041|NCT00046735|Drug|Lenalidomide|The planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT
12080042|NCT00046722|Drug|Smoked Marijuana|
12080043|NCT00046527|Drug|ABI-007|
12080044|NCT00046514|Drug|ABI-007|
12080045|NCT00046423|Drug|ABI-007|
12080046|NCT00046709|Drug|Smoked Marijuana|
12080047|NCT00046696|Drug|NM-3|
12080048|NCT00046683|Drug|alemtuzumab|
12080049|NCT00046540|Drug|Liposome-encapsulated SN38|
12080050|NCT00046501|Drug|Lantus (insulin glargine [rDNA origin] injection)|
12080051|NCT00046501|Drug|Humulin N|
12080052|NCT00046501|Drug|Humulin L|
12080053|NCT00046501|Drug|Lispro|
12080054|NCT00046488|Drug|IDEC-152|6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4
12080055|NCT00046475|Drug|Midodrine Hydrochloride|
12080056|NCT00046462|Drug|Lantus (insulin glargine [rDNA origin] injection)|
12080057|NCT00046462|Drug|Metformin|
12080058|NCT00046462|Drug|Glyburide|
12080059|NCT00046462|Drug|Thiazolidinedione|
12080060|NCT00046449|Drug|Investigational Seasonal Affective Disorder (SAD) Drug|
12080061|NCT00046566|Dietary Supplement|Soy protein-milk protein-carbohydrate|40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks
12080062|NCT00046566|Dietary Supplement|Milk protein-carbohydrate-soy protein|40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.
12080063|NCT00046566|Behavioral|Carbohydrate-soy protein-milk protein|40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks,
12080064|NCT00046553|Drug|RU-486 (Mifepristone)|
12080065|NCT00046384|Drug|aripiprazole|
12080066|NCT00046397|Drug|Modified Vaccinia Virus Ankara TBC-M|
12080067|NCT00046345|Drug|Atazanavir (BMS-232632)|
12080068|NCT00046332|Drug|GW810781|
12080069|NCT00046319|Drug|BSF 208075|
12080070|NCT00046306|Drug|Antioxidants|
12080071|NCT00046358|Drug|Lovostatin|
12080072|NCT00046358|Drug|Ibuprofen|
12080073|NCT00046293|Drug|Reopro|
12080074|NCT00046293|Drug|Retrovase|
12080075|NCT00046267|Drug|Niacin|
12080076|NCT00046254|Drug|Zoledronic Acid|
12080077|NCT00046241|Drug|Extended-release bupropion hydrochloride|
12080078|NCT00046228|Drug|abciximab placebo; reteplase placebo, abciximab, abciximab|placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
12080079|NCT00046228|Drug|Abciximab; reteplase; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
12080080|NCT00046228|Drug|abciximab; reteplase placebo; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
12080081|NCT00046228|Drug|abciximab placebo; reteplase placebo, abciximab, abciximab|placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
12080082|NCT00046228|Drug|abciximab; reteplase placebo; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
12080083|NCT00046228|Drug|Abciximab; reteplase; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
12080084|NCT00046176|Drug|abacavir/lamivudine|
12080085|NCT00046176|Drug|abacavir|
12080086|NCT00046176|Drug|lamivudine|
12080087|NCT00046163|Drug|midodrine hydrochloride (ProAmatine®)|
12080088|NCT00046150|Drug|Insulin glulisine (HMR1964)|
12080089|NCT00046137|Drug|teriparatide|
12080090|NCT00046137|Drug|raloxifene|
12080091|NCT00046137|Drug|placebo|
12080092|NCT00046111|Drug|topotecan|A topoisomerase I inhibitor used for ovarian and lung cancer treatment
12080093|NCT00046085|Behavioral|Online Family Education|Families were provided with private, secure access to the website, which features family-to-family chat capabilities, video lectures on the management of schizophrenia, written materials on important issues in schizophrenia management, professionally facilitated online discussions of the material, and additional resource links.
12080094|NCT00046085|Behavioral|Customary care|Participants received care as usual.
12080095|NCT00046072|Drug|E5564|
12080096|NCT00046033|Drug|Lopinavir/ritonavir|
12080097|NCT00046033|Drug|Ritonavir|
12080098|NCT00046033|Drug|Saquinavir|
12080099|NCT00046033|Drug|Tenofovir disoproxil fumarate|
12080100|NCT00046033|Drug|Amprenavir|
12080101|NCT00046020|Drug|Venlafaxine ER|
12080102|NCT00045994|Drug|ALT-711|
12080103|NCT00045981|Drug|ALT-711|
12080104|NCT00045968|Drug|Dendritic cell immunotherapy|Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.
12080105|NCT00045955|Drug|Fexofenadine, Comparator = Montelukast|
12080106|NCT00045942|Drug|Itraconazole|Itraconazole was commercially available.
12080107|NCT00045942|Drug|PKC412|PKC412 was supplied as soft gelatin capsules containing 25 mg PKC412.
12080108|NCT00045916|Procedure|High dosage electroconvulsive therapy|Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
12080109|NCT00045916|Drug|Nortriptyline|Participants will receive nortriptyline.
12080110|NCT00045916|Drug|Venlafaxine|Participants will receive venlafaxine.
12080111|NCT00045916|Drug|Lithium|Participants will receive lithium.
12080112|NCT00045916|Procedure|Low dosage electroconvulsive therapy|Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.
12080113|NCT00045903|Behavioral|Exposure and Ritual Prevention (Cognitive Behavioral Therapy)|
12080114|NCT00045903|Behavioral|Stress Management Therapy (Cognitive Behavior Therapy)|
12080115|NCT00044824|Drug|Fexofenadine|
12080116|NCT00044811|Drug|Fexofenadine|
12080117|NCT00045877|Drug|Recombinant Human Interleukin-2 and Rituximab|
12080118|NCT00045864|Drug|Recombinant Human Interleukin-2 and Rituximab|
12080119|NCT00045838|Drug|VCR-HIVDNA006-00-VP|
12080120|NCT00045812|Drug|SCH-58235|
12080121|NCT00045799|Drug|Omeprazole sodium bicarbonate immediate release PWD/FS|
12080122|NCT00045799|Drug|Cimetidine IV|
12080123|NCT00045786|Drug|CC-1088|400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
12080124|NCT00045773|Drug|Sertraline|50 - 200mg, once per day for 12 weeks.
12080125|NCT00045760|Drug|Drotrecogin alfa (activated)|
12080126|NCT00044928|Drug|Piperacillin/Tazobactam|
12080127|NCT00044915|Drug|Repinotan HCl (BAYX3702)|All patients receive 1.25 mg of repinotan
12080128|NCT00044915|Drug|Placebo|All patients receive 1.25 mg of placebo
12080129|NCT00044902|Drug|epratuzumab|
12080130|NCT00044889|Drug|clofarabine (IV formulation)|
12080131|NCT00044863|Biological|Erbitux (Cetuximab)|400 mg/m2 initial dose, 250 mg/m2 weekly
12080132|NCT00044837|Drug|Medroxyprogesterone acetate|
12080133|NCT00044837|Drug|Estradiol|
12080134|NCT00044876|Drug|CDB-2914|
12080135|NCT00044798|Procedure|Repetitive transcranial magnetic stimulation (rTMS)|Participants will receive 15 treatments of rTMS over 3 weeks.
12080136|NCT00044798|Drug|Citalopram|After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.
12080137|NCT00044798|Procedure|Sham rTMS|Participants will receive 15 treatments of sham rTMS over 3 weeks.
12080138|NCT00044785|Drug|triacetyluridine|
12080139|NCT00044785|Drug|fluorouracil|
12080140|NCT00044785|Drug|leucovorin|
12080141|NCT00044785|Drug|camptosar|
12080142|NCT00044772|Drug|Venlafaxine ER|
12080143|NCT00044759|Drug|Piperacillin/Tazobactam (Tazocin)|
12080144|NCT00044746|Drug|Piperacillin/Tazobactam|
12080145|NCT00044733|Drug|Mylotarg (gemtuzumab ozogamicin) Injection|
12080146|NCT00044720|Drug|Rapamune|
12080147|NCT00044707|Drug|Pramlintide acetate|Clear, colorless, sterile solution for SC injection.
12080148|NCT00044694|Drug|Placebo 0.01 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
12080149|NCT00044694|Drug|Placebo 0.02 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
12080150|NCT00044694|Drug|Placebo 0.03 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
12080151|NCT00044694|Drug|Placebo 0.04 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
12080152|NCT00044694|Drug|AC2993 2.5 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
12080153|NCT00044694|Drug|AC2993 5.0 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
12080154|NCT00044694|Drug|AC2993 7.5 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
12080155|NCT00044694|Drug|AC2993 10.0 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
12080156|NCT00044681|Drug|risperidone|
12080157|NCT00044668|Drug|AC2993|Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.
12080158|NCT00044655|Drug|Risperidone|As prescribed by routine prescriber (not dictated by study protocol)
12080159|NCT00044655|Drug|Olanzapine|As prescribed by routine prescriber (not dictated by study protocol)
12080160|NCT00044655|Drug|Ziprasidone|As prescribed by routine prescriber (not dictated by study protocol)
12080161|NCT00044655|Drug|Quetiapine|As prescribed by routine prescriber (not dictated by study protocol)
12080162|NCT00044655|Drug|Aripiprazole|As prescribed by routine prescriber (not dictated by study protocol)
12080163|NCT00044642|Drug|Lorazepam|
12080164|NCT00044629|Behavioral|Cognitive-Behavioral Therapy for Insomnia|
12080165|NCT00044629|Drug|zolpidem tartrate (Ambien)|
12080166|NCT00044629|Drug|Placebo|
12080167|NCT00044616|Drug|Fluoxetine|
12080168|NCT00044616|Drug|Lithium|
12080169|NCT00044577|Drug|abacavir/lamivudine|
12080170|NCT00044577|Drug|abacavir|
12080171|NCT00044577|Drug|lamivudine|
12080172|NCT00044577|Drug|tenofovir|
12080173|NCT00044564|Drug|Bay 59-8862|75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal
12080174|NCT00044551|Drug|Taxane (Cytotoxic, BAY59-8862)|Daily 1 h infusion every 3 weeks
12080175|NCT00044538|Drug|BAY59-8862 (Cytotoxic Taxane)|Intravenous dose over 60 minutes every 3 weeks
12080176|NCT00044525|Drug|BAY59-8862 (Cytotoxic Taxane)|1 h intravenous infusion every 3 weeks
12080177|NCT00044512|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
12080178|NCT00044486|Drug|Posaconazole oral suspension|
12080179|NCT00044473|Drug|levofloxacin|
12080180|NCT00044460|Drug|rosiglitazone|
12080181|NCT00044447|Drug|Glimepiride|
12080182|NCT00044434|Drug|bupropion (Wellbutrin)|
12080183|NCT00044421|Drug|Ruboxistaurin mesylate|
12080184|NCT00044408|Drug|Ruboxistaurin mesylate|
12080185|NCT00044395|Drug|Ruboxistaurin mesylate|
12080186|NCT00044382|Drug|CC-5013|
12080187|NCT00044369|Procedure|Varicocele repair|
12080188|NCT00044356|Genetic|Allovectin-7®|
12080189|NCT00044343|Drug|lapatinib|
12080193|NCT00044291|Drug|aromatase inhibition|
12080194|NCT00044291|Procedure|hormone therapy|
12080195|NCT00044291|Procedure|endocrine therapy|
12080196|NCT00044291|Procedure|antiestrogen therapy|
12080197|NCT00044304|Drug|Imatinib|The dosing regimen to be used initially (400 mg po qd in adults and 260 mg/m2/day in children with food and a glass of water) is identical to that recommended by the FDA for the treatment of the chronic phase of chronic myelogenous leukemia (CML) (Prod Info Gleevec ). In patients with ANC<1500/mm3, platelet counts < 75,000mm3 or abnormal liver function tests (ALT or AST > 2.5 or bilirubin > 3 times the upper limit of normal), the starting dose will be reduced to 300 mg poqD.
12080198|NCT00044304|Drug|Ruxolitinib|The dosing regimen to be used initially (15 mg po bid) is identical to that recommended by the FDA for the treatment of myelofibrosis with platelet counts of 100-200,000/mm3 (Prod Info ruxolitinib). In patients with platelet counts <100,000/mm3, moderate renal impairment (CrCl <60 ml/min) or abnormal liver function tests (AlT or AST > 2.5 or bilirubin > 3 times the upper limit of normal), the starting dose will be reduced to 10 mg bid. The recommended guidelines for dose adjustment during therapy and discontinuation of therapy in myelofibrosis will be followed.
12080199|NCT00044278|Drug|lamotrigine|
12080200|NCT00044265|Drug|ramipril|
12080201|NCT00044226|Drug|ML-04A|
12080202|NCT00044213|Drug|EDTA|Participants will receive 40 infusions of standard chelation solution.
12080203|NCT00044213|Drug|EDTA Placebo|Participants will receive 40 infusions of EDTA placebo.
12080204|NCT00044213|Dietary Supplement|High Dose Vitamin|
12080205|NCT00044213|Dietary Supplement|High Dose Vitamin Placebo|
12080206|NCT00044187|Drug|Sibutramine|
12080207|NCT00044148|Drug|LY333531|
12080208|NCT00044135|Drug|clevudine (drug)|
12080209|NCT00044070|Drug|YM872 (zonampanel)|
12080210|NCT00044057|Drug|YM872 (zonampanel), t-PA (alteplase)|
12080211|NCT00044044|Drug|Lurasidone 20 mg|Lurasidone 20mg/day tablets
12080212|NCT00044044|Drug|Lurasidone 40mg|Lurasidone 40mg/day tablets
12080213|NCT00044044|Drug|Lurasidone 80 mg|Lurasidone 80mg/day - 2 40mg tablets
12080214|NCT00044044|Drug|Haloperidol 10mg|Haloperidol 10mg/day tablets
12080215|NCT00044044|Drug|Placebo|Matching Placebo to Lurasdione and Haloperidol
12080216|NCT00044031|Biological|G17DT Immunogen|
12080217|NCT00044018|Drug|CDC-501|
12080218|NCT00044005|Drug|Lurasidone 20 mg|Lurasidone 20mg oral tablet taken once daily for 6-months
12080219|NCT00044005|Drug|Lurasidone 40 mg|Lurasidone 40mg oral tablets taken once daily
12080220|NCT00044005|Drug|Lurasidone 80mg|Lurasidone 80mg oral tablet taken once daily
12080221|NCT00043329|Drug|Actimmune Registry|as administered by physician
12080222|NCT00044109|Device|Magnets|
12080223|NCT00044083|Other|Placebo|Placebo: One capsule 3 times a day from Day 1 to Day 7
12080224|NCT00044083|Drug|Tolcapone|Tolcapone: One capsule 3 times a day from Day 1 to Day 7
12080225|NCT00043966|Drug|Lopinavir/ritonavir|
12080226|NCT00043966|Drug|Tenofovir DF|
12080227|NCT00043966|Drug|Emtricitabine|
12080228|NCT00043953|Drug|Lopinavir/ritonavir|
12080229|NCT00043953|Drug|Saquinavir mesylate|
12080230|NCT00043953|Drug|Lamivudine/zidovudine|
12080231|NCT00043888|Drug|fosamprenavir|
12080232|NCT00043888|Drug|COMBIVIR|
12080233|NCT00043888|Drug|ritonavir|
12080234|NCT00043888|Drug|TRIZIVIR|
12080235|NCT00043979|Drug|F-18 Fluorodeoxyglucose|
12080236|NCT00043979|Biological|therapeutic allogeneic lymphocytes|Lymphocyte cells are collected from a healthy donor by apheresis and infused into the patient with a central venous catheter.
12080237|NCT00043979|Drug|cyclophosphamide|"Induction - 750 mg/m^2 intravenous (IV) infusion over 30 minutes x 1 dose. Day 5.
~Transplant - 1200 mg/m^2 per day IV infusion over 2 hours daily for 4 days; days -6, -5, -4, -3."
12080238|NCT00043979|Drug|cyclosporine|6 mg/kg per dose orally every other day (no day 9 dose).
12080239|NCT00043979|Drug|doxorubicin hydrochloride|Induction - 10 mg/m^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.
12080240|NCT00043979|Drug|etoposide|50 mg/m^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.
12080241|NCT00043979|Drug|fludarabine phosphate|"Induction - 25 mg/m^2 per day intravenous (IV) infusion over 30 minutes daily for 3 days. Days 1, 2, 3.
~Transplant - 30 mg/m^2 per day IV infusion over 30 minutes daily for 4 days; days -6, -5, -4, -3."
12080242|NCT00043979|Drug|melphalan|Transplant - 100 mg/m^2 per day intravenous (IV) infusion over 15 minutes for 1 day; day -2.
12080243|NCT00043979|Drug|prednisone|Induction - 60 mg/m^2 per day in 2-4 divided doses by mouth daily for 5 days; days 1, 2, 3, 4, 5.
12080244|NCT00043979|Drug|sirolimus|Initiated on day +3. Patients >40kg, the initial dose will be 2 mg every 24 hours orally. Patients <40 kg, the initial dose will be 1 mg/m^2.
12080245|NCT00043979|Drug|tacrolimus|Day -1 at least 24 hours before the stem cell infusion at a dose of 0.03 mg/kg/day as a continuous infusion. Twelve hours later oral dose initiated at a dose of 0.1-0.15 mg/kg/day in two divided doses every 12 hours.
12080246|NCT00043979|Drug|vincristine sulfate|Induction - 0.4 mg/m^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days; 1, 2, 3, 4.
12080247|NCT00043979|Procedure|peripheral blood stem cell transplantation|Stem cells from a healthy donor are collected and transplanted into the patient using a central venous catheter.
12080248|NCT00043979|Drug|Filgrastim|
12080249|NCT00043979|Procedure|Peripheral Blood Stem Cell donation|
12080250|NCT00043940|Drug|bivalirudin|Bivalirudin therapy will be given as a 0.75-mg/kg intravenous bolus and 1.75-mg/kg/h intravenous infusion during procedure and up to 4 hours.
12080251|NCT00043927|Drug|topotecan/cisplatin|
12080252|NCT00043927|Drug|etoposide/cisplatin|
12080253|NCT00043914|Drug|lamotrigine|
12080254|NCT00043901|Drug|lamotrigine|
12080255|NCT00043875|Drug|lamotrigine|
12080256|NCT00043862|Drug|topotecan|
12080257|NCT00043849|Drug|Quetiapine|
12080258|NCT00043836|Drug|ALT-711|
12080259|NCT00043823|Drug|Avastin|7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle
12080260|NCT00043823|Drug|Tarceva|100 mg By Mouth Daily for 3 Weeks
12080261|NCT00043810|Procedure|Gelonin|Gelonin-AntiCD33 purging, 3 purging concentrations (fixed dose of 5 x 10^6 CD34+ cells/kg to be infused) with 3 dose levels of 1 nanomolar, 5.0 nanomolar and 10.0 nanomolar.
12080262|NCT00043810|Drug|Busulfan|130 mg/m2 in normal saline over three (3) hours IV every twenty-four (24) hours for four (4) consecutive days (days -6 to -3).
12080263|NCT00043810|Drug|Fludarabine|40 mg/m2 in 100 ml of saline over one (1) hour on each of four (4) consecutive days (days - 6 to -3).
12080264|NCT00043797|Drug|Lidorestat (IDD 676)|
12080265|NCT00043784|Drug|enoxaparin|
12080266|NCT00043693|Behavioral|Family Intervention for Dual Diagnosis|The family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats.
12080267|NCT00043693|Behavioral|Family psychoeducation program|The family psychoeducation program consists of 6 weekly sessions.
12080268|NCT00043771|Drug|Tolvaptan|
12080269|NCT00043758|Drug|Tolvaptan|
12080270|NCT00043745|Dietary Supplement|Soy isoflavones|Soy isoflavones extracted from soy protein, compressed into tablets; three tablets taken daily
12080271|NCT00043745|Dietary Supplement|Extract tablets|Extract from soy protein, but devoid of isoflavones; three tablets taken once daily
12080272|NCT00043732|Drug|SCIO-469|
12080273|NCT00043719|Drug|Nitroglycerin ointment|
12080274|NCT00043719|Drug|Calcium supplement with vitamin D|
12080275|NCT00043706|Drug|Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody|
12080276|NCT00043602|Behavioral|Standard interpersonal psychotherapy (IPT)|Participants will receive 12 sessions of IPT over 12 weeks.
12080277|NCT00043602|Behavioral|Clinician managed interpersonal psychotherapy (CM-IPT)|Participants will receive 12 sessions of CM-IPT over 1 year.
12080278|NCT00043589|Drug|donepezil|
12080279|NCT00043589|Procedure|Memory-training class|
12080280|NCT00043576|Drug|calcitriol|
12080281|NCT00043576|Drug|docetaxel|
12080282|NCT00043680|Drug|Celecoxib|
12080283|NCT00043667|Drug|Daclizumab|
12080284|NCT00043654|Drug|Mifepristone|
12080285|NCT00043628|Procedure|Stem Cell Mobilization|
12080286|NCT00043563|Behavioral|Cognitive-Behavior Therapy|
12080287|NCT00043550|Behavioral|Supportive Expressive Therapy|The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
12080288|NCT00043550|Drug|Sertraline|Participants will receive sertraline.
12080289|NCT00043550|Drug|Pill Placebo|Participants will receive a pill placebo.
12080290|NCT00043550|Drug|Venlafaxine|Participants will receive venlafaxine.
12080291|NCT00043537|Behavioral|Social Effectiveness Therapy for Children (SET-C)|
12080292|NCT00043537|Drug|Fluoxetine|
12080293|NCT00043537|Drug|Pill Placebo|
12080294|NCT00043511|Biological|pGA2/JS2 Plasmid DNA Vaccine|
12080295|NCT00043459|Drug|intravenous T900607-sodium|
12080296|NCT00043446|Drug|intravenous T900607-sodium|
12080297|NCT00043433|Drug|intravenous T900607-sodium|
12080298|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.08mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080299|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.16mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080300|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.24mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080301|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.28mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080302|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.32mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080303|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.36mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080304|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 10 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080305|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
12080306|NCT00043407|Drug|CPG 7909|In the phase I portion of the protocol, patients will be included in escalating dose groups: 0.08, 0.12, 0.16, 0.36, 0.54 or 0.81 mg/kg of CPG 7909 Injection. Patients will be treated once weekly subcutaneously for 24 weeks. In the Phase II portion of the trial patients will be treated at the MTD or the highest dose of 0.81 mg/kg identified in the Phase I dose escalation portion of the trial. All patients in Phase I and Phase II will be treated until disease progression or a maximum of 24 weeks.
12080307|NCT00043394|Drug|0.04 mg/kg CpG 7909|0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
12080308|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
12080309|NCT00043394|Drug|0.08 mg/kg CpG 7909|0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
12080310|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
12080311|NCT00043394|Drug|0.12 mg/kg CpG 7909|0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
12080312|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
12080313|NCT00043394|Drug|0.16 mg/kg CpG 7909|0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
12080314|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
12080315|NCT00043381|Drug|decitabine (5-aza-2'deoxycytidine)|
12080316|NCT00043368|Drug|PF-3512676|PF-3512676 IV at doses: 0.01mg/kg, 0.16mg/kg and 0.32mg/kg PF-3512676 Injection given by subcutaneous injection at doses: 0.04mg/kg, 0.16mg/kg, 0.20mg/kg, 0.28mg/kg, 0.32mg/kg, 6mg, 10mg, 40mg.
12080317|NCT00043355|Drug|interferon gamma-1b|500 mcg, oral, three times weekly
12080318|NCT00043342|Drug|interferon gamma-1b|100 or 200 mcg, SQ, 3x per week
12080319|NCT00043316|Drug|interferon gamma-1b|500 or 1000 mcg, inhalation, 3x per week
12080320|NCT00043303|Drug|interferon gamma-1b|100 or 200 mcg, SQ, 3x per week
12080321|NCT00043277|Drug|Angiomax (bivalirudin)|
12080322|NCT00043264|Drug|Rifampin|
12080323|NCT00043264|Drug|Azithromycin|
12080324|NCT00043212|Drug|Dendritic cell immunotherapy|
12080325|NCT00043199|Drug|Aroplatin (Liposomal NDDP, L-NDDP)|
12080326|NCT00043186|Drug|Placebo|Placebo subcutaneous injection
12080327|NCT00043186|Drug|Denosumab|Denosumab for subcutaneous injection
12080328|NCT00043186|Drug|Alendronate|Alendronate 70 mg tablets
12080329|NCT00042718|Drug|levofloxacin, azithromycin, amoxicillin/clavulanate|
12080330|NCT00042679|Drug|Gemcitabine|
12080331|NCT00042679|Drug|Carboplatin|
12080332|NCT00042679|Drug|LY900003|
12080333|NCT00042666|Drug|LY317615|500 mg, oral, QD, up to six 28 day cycles
12080334|NCT00042653|Drug|Placebo|30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally
12080335|NCT00042653|Drug|AMG 073|30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally
12080336|NCT00042601|Drug|Pramlintide acetate|Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
12080337|NCT00042601|Drug|Placebo|placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper
12080338|NCT00042588|Drug|Recombinant Chimeric Monoclonal Antibody|
12080339|NCT00042575|Drug|Duloxetine|
12080340|NCT00042562|Drug|duloxetine|
12080341|NCT00042549|Device|Extracorporeal Shock Wave Lithotripsy|
12080342|NCT00042549|Drug|ursodiol|
12080343|NCT00042536|Drug|Naltrexone HCL/ Yohimbine HCL|
12080344|NCT00042510|Biological|Treatment group|
12080345|NCT00042497|Biological|autologous dexosomes loaded with tumor-specific peptides|
12080346|NCT00042484|Procedure|Community-level intervention & policy change|
12080347|NCT00042471|Drug|Pramlintide acetate|Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.
12080348|NCT00042458|Drug|Pramlintide acetate|Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
12080349|NCT00042458|Drug|Placebo|The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
12080350|NCT00042432|Drug|cinacalcet (AMG 073)|Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
12080351|NCT00042406|Drug|HuMax-CD4|
12080352|NCT00042393|Drug|Adefovir Dipivoxil|
12080353|NCT00042367|Drug|Induction therapy (Regimen 1, Course 1, Cycle A1|"2-8 hrs: Cisplatin 3.5 mg/kg + mannitol 0.4 g/kg in D5 NS (1000 ml/m2) over 6 hrs at approximately 167ml/m2/hr. 8-12 hrs: D5 NS (665 ml/m2) + KCl (2 mEq/100 ml) +MgSO4 (0.5 mEq/100 ml) at approximately 167ml/m2/hr.
~12-24 hrs: D5 NS + KCl (2 mEq/100 ml) + MgSO4 (0.5mEq/100 ml) at approximately 65 ml/m2/hr.
~Days 2,3: 0 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg of IVF over 15 min 15 min: Cyclophosphamide 30 mg/kg IV over 30 min 45 min: Post-chemotherapy hydration - D5 1/2 NS + KCl(1 mEq/100 ml) at approximately 130 ml/m2/hr for at least 24 hours.
~3 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 6 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 9 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 12 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min Day 4 G-CSF 5 µg/kg subcutaneously, daily until ANC ≥ 2000 on two consecutive days, post ANC nadir.
~Day 8: Vincristine 0.05 mg/kg IV push (max dose = 2 mg) Day 15: Vincristine 0.05 mg/kg IV push (max dose = 2 mg)"
12080354|NCT00042367|Drug|Regimen 1, Course 1, Cycle A2 (Days 22 - 42)|Drugs and doses are same as in Cycle A1. Cycle A2 begins following recovery from Cycle A1, but no sooner than day 21. Patients with delays in recovery beyond day 28 should have dose modifications
12080355|NCT00042367|Drug|Cycle B|"Days 43 - 63) Etoposide, 1.7 mg/kg p.o. qd x 21 days. The dose will be diluted immediately prior to administration in juice flavored syrup to a final concentration of 0.4 Each dose should be aken 1 hour before or 2 hours after a meal.
~Cycle B begins following recovery from Cycle A2; however, it begin no sooner than 21 days after the start of Cycle A2.
~Monitor weekly CBC/diff/plt. If ANC < 500/mm3 or platelets (unsupported) < 50,000/mm3 then discontinue etoposide. A 25% reduction should be made for the next cycle of oral etoposide.
~Interim Response Evaluation (Days 64 - 70) Interim Response Evaluation should be performed the week following the completion of Course 1."
12080356|NCT00042367|Drug|Regimen 1, Course 2|6.3.3 Regimen 1, Course 2 Repeat systemic therapy as per Course 1 (Cycle A1, Cycle A2, and Cycle B) in patients with SD or better at the interim response evaluation (see Figure 2 for IT mafosfamide guidelines). Course 2 should not begin any sooner than 7 days after the completion of Course 1.
12080357|NCT00042367|Drug|Intrathecal Mafosfamide|Regimen 1, Course 1 Mafosfamide, 14 mg, is given two times/week during Cycle A1 and Cycle A2 of Course 1, for 12 total doses during days 1-41. The first dose of Cycles A1 and A2 should be given, if possible, on the same day as the first I.V. cyclophosphamide dose and the second dose 3 to 4 days later. The assigned dose is given one time/week during Cycle B, Course 1 for 3 total doses during days 43 - 63.
12080394|NCT00042289|Drug|ofloxacin|Women will receive ofloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080395|NCT00042289|Drug|ethionamide/prothionamide|Women will receive ethionamide/prothionamide as prescribed by their clinicians. (Dosage will vary for each participant.)
12080396|NCT00042289|Drug|terizidone/cycloserine|Women will receive terizidone/cycloserine as prescribed by their clinicians. (Dosage will vary for each participant.)
12080358|NCT00042367|Drug|Regimen 1 Course 2, IT mafosfamide|"Regimen 1, Course 2 The assigned dose is administered once with IV cyclophosphamide during each of Cycle A1 and Cycle A2, and day 1 of Cycle B for a total of 3 doses during Course 2.
~Patients with an initially abnormal flow study, who show no evidence of obstructive hydrocephalus or compartmentalization on the repeat study, may begin intrathecal mafosfamide administration with the initiation of Regimen 1, Course 2. The frequency of intrathecal mafosfamide administration, for such patients, will be as outlined in Regimen 1, Course
~1."
12080359|NCT00042367|Drug|Regimen 2, Course 1|"Cycle C1 (Days 1 - 21) Day 1: Prehydrate with D5W 1/2 NS + KCl 2 mEq/100 ml) at 2 times the hourly maintenance rate until the urine specific gravity is < 1.012.
~0 hrs: Mesna 6 mg/kg IV over 15 min. Dilute in 0.65 ml/kg IVF. 15 min: Vincristine 0.05 mg/kg IV push (Day 1 only)(max dose = 2 mg) 20 min: Cyclophosphamide 30 mg/kg IV over 30 min. 50 min: Post-chemotherapy hydration - D5 1/2 NS + KCl
~(1 mEq/100 ml) at twice the hourly maintenance rate for at least 24 hours. 3 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 6 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 9 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 12 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min Day 2: Repeat day 1, but omit vincristine. Day 3: G-CSF 5 µg/kg/day subcutaneously, daily, until ANC is > 2000 on two consecutive days, post ANC nadir."
12080360|NCT00042367|Drug|Regimen 2, Course, 1, Cycle C1|"Cycle C1, Weeks 2 and 3 Day 8: Vincristine 0.05 mg/kg IV push (max dose = 2 mg) Day 15: Vincristine 0.05 mg/kg IV push (max dose = 2 mg) Cycle C2 (Days 22-42) Drugs and doses are same as in Cycle C1. Cycle C2 begins following recovery from Cycle C1, but no sooner than day 21. Patients with delays in recovery beyond day 28 should have dose modificationsCycle D (Days 43 - 63) Etoposide 1.7 mg/kg, po qd x 21 days The dose will be diluted immediately prior to administration in juice or flavored syrup as per section 3.4.3. Each dose should be taken 1 hour before or 2 hours after a meal.
~Cycle D should begin following recovery from Cycle C2; however, it should begin no sooner than 21 days after the start of Cycle C2."
12080361|NCT00042367|Drug|Regimen 2, Course 2|Repeat Course 1 (Cycle C1, Cycle C2, and Cycle D) in patients with SD or better at the interim response evaluation. Chemotherapy should begin as soon as the patient has recovered from the toxicities of oral etoposide in cycle D, course 1. However, it should not begin any sooner than 7 days after the completion of Course 1.
12080362|NCT00042367|Radiation|radiation therapy|"Conformal Irradiation Patients who are initially M0 with a CR, PR, or SD to Regimen 1 induction chemotherapy (with or without second surgery) will receive local irradiation using conformal techniques. Treatment will commence within 2 weeks of completing Regimen 1 or second surgery. Treatment planning and technique may involve 3D conformal,IMRT, or proton planning and delivery, provided the guidelines regarding volume, dose,and normal tissue restrictions are honored.
~8.3.1 Fraction Size 180 cGy fractions will be used for all target volumes. 8.3.2 Fractionation Conventional fractionation will be used. Treatments will be given once daily, 5 days/week except for necessary interruptions secondary to medical or administrative reasons."
12080363|NCT00042354|Drug|clofarabine (IV formulation)|
12080364|NCT00042341|Drug|clofarabine (IV formulation)|
12080365|NCT00042328|Drug|Valacyclovir|
12080366|NCT00042315|Procedure|Chemotherapy|
12080367|NCT00042315|Drug|tariquidar + vinorelbine|
12080368|NCT00042315|Drug|placebo + vinorelbine|
12080369|NCT00042302|Procedure|Chemotherapy|
12080370|NCT00042302|Drug|tariquidar + paclitaxel/carboplatin|
12080371|NCT00042302|Drug|placebo + paclitaxel/carboplatin|
12080372|NCT00042289|Drug|atazanavir/cobicistat|Women will receive atazanavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
12080373|NCT00042289|Drug|darunavir/ritonavir|Women will receive darunavir/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)
12080374|NCT00042289|Drug|darunavir/cobicistat|Women will receive darunavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
12080375|NCT00042289|Drug|etravirine|Women will receive etravirine as prescribed by their clinicians. (Dosage will vary for each participant.)
12080376|NCT00042289|Drug|elvitegravir/cobicistat|Women will receive elvitegravir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
12080377|NCT00042289|Drug|dolutegravir|Women will receive dolutegravir as prescribed by their clinicians. (Dosage will vary for each participant.)
12080378|NCT00042289|Drug|tenofovir alafenamide fumarate (TAF)|Women will receive TAF as prescribed by their clinicians. (Dosage will vary for each participant.)
12080379|NCT00042289|Drug|TAF/cobicistat|Women will receive TAF/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
12080380|NCT00042289|Drug|TAF/ritonavir|Women will receive TAF/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)
12080381|NCT00042289|Drug|efavirenz|Women will receive efavirenz as prescribed by their clinicians. (Dosage will vary for each participant.)
12080382|NCT00042289|Drug|lopinavir/ritonavir|Women will receive lopinavir/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)
12080383|NCT00042289|Drug|nevirapine|Women will receive nevirapine as prescribed by their clinicians. (Dosage will vary for each participant.)
12080384|NCT00042289|Drug|rifampicin|Women will receive rifampicin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080385|NCT00042289|Drug|ethambutol|Women will receive ethambutol as prescribed by their clinicians. (Dosage will vary for each participant.)
12080386|NCT00042289|Drug|isoniazid|Women will receive isoniazid as prescribed by their clinicians. (Dosage will vary for each participant.)
12080387|NCT00042289|Drug|pyrazinamide|Women will receive pyrazinamide as prescribed by their clinicians. (Dosage will vary for each participant.)
12080388|NCT00042289|Drug|rifampicin|Women will receive rifampicin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080389|NCT00042289|Drug|kanamycin|Women will receive kanamycin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080390|NCT00042289|Drug|amikacin|Women will receive amikacin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080391|NCT00042289|Drug|capreomycin|Women will receive capreomycin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080392|NCT00042289|Drug|moxifloxacin|Women will receive moxifloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080393|NCT00042289|Drug|levofloxacin|Women will receive levofloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)
12080397|NCT00042289|Drug|para-aminosalicylic acid (PAS)|Women will receive PAS as prescribed by their clinicians. (Dosage will vary for each participant.)
12080398|NCT00042289|Drug|high dose isoniazid (INH)|Women will receive high dose INH as prescribed by their clinicians. (Dosage will vary for each participant.)
12080399|NCT00042289|Drug|bedaquiline|Women will receive bedaquiline as prescribed by their clinicians. (Dosage will vary for each participant.)
12080400|NCT00042289|Drug|clofazamine|Women will receive clofazamine as prescribed by their clinicians. (Dosage will vary for each participant.)
12080401|NCT00042289|Drug|delamanid|Women will receive delamanid as prescribed by their clinicians. (Dosage will vary for each participant.)
12080402|NCT00042289|Drug|linezolid|Women will receive linezolid as prescribed by their clinicians. (Dosage will vary for each participant.)
12080403|NCT00042289|Drug|pretomanid|Women will receive pretomanid as prescribed by their clinicians. (Dosage will vary for each participant.)
12080404|NCT00042289|Drug|atazanavir/ritonavir/tenofovir|Women will receive atazanavir/ritonavir/tenofovir as prescribed by their clinicians. (Dosage will vary for each participant.)
12080405|NCT00042289|Drug|ethinyl estradiol oral contraceptive|Women will receive ethinyl estradiol oral contraceptive as prescribed by their clinicians. (Dosage will vary for each participant.)
12080406|NCT00042289|Drug|etonogestrel implant|Women will receive etonogestrel implant as prescribed by their clinicians. (Dosage will vary for each participant.)
12080407|NCT00041483|Drug|Anecortave Acetate 15 mg sterile suspension|
12080408|NCT00041483|Other|Photodynamic Therapy (PDT)|
12080409|NCT00042380|Drug|Novasoy|
12080410|NCT00042250|Drug|Chemotherapy for hematologic malignancy|
12080411|NCT00042237|Behavioral|Schema Therapy|
12080412|NCT00042224|Procedure|Electroconvulsive Therapy (ECT)|ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
12080413|NCT00042224|Drug|Clozapine|Patients with psychotic symptoms will receive clozapine
12080414|NCT00042211|Behavioral|Problem Solving Treatment|Brief Cognitive Behavioral Therapy
12080415|NCT00042211|Behavioral|Control|No treatment control
12080416|NCT00042198|Behavioral|Cognitive behavior therapy|Up to 12 weekly, individual, hour-long sessions
12080417|NCT00042198|Behavioral|Supportive Stress Management|Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
12080418|NCT00042185|Behavioral|Dissonance Eating Disorder Prevention Program|In this intervention, participants voluntarily engaged in verbal, written, and behavioral exercises in which they critiqued the thin-ideal ideal. These exercises were conducted in sessions and in homework activities. For example, they wrote a counter-attitudinal essay about the costs associated with pursuit of the thin-ideal and engaged in a counter-attitudinal role-play in which they attempted to dissuade facilitators from pursuing the thin-ideal.
12080419|NCT00042185|Behavioral|Healthy Weight Intervention|In this intervention, participants were encouraged to make gradual healthy and lasting changes to their diet and physical activity to balance their energy needs with their energy intake, and thereby achieve a healthier weight and body satisfaction. With support from the facilitator and group members, they initiated an individual lifestyle change plan to reduce intake of fat and sugar and to increase exercise using behavioral modification principles. Food and exercise diaries were used to identify behaviors to target in this lifestyle modification and to monitor change. Motivational enhancement activities were used to promote motivation for behavior change.
12080420|NCT00042185|Behavioral|Expressive Writing Control Condition|In this condition, which is based on the work of Pennebaker (1997), participants wrote about emotionally significant topics in three individual weekly 45-minute sessions. They were told that research indicates that body dissatisfaction is linked to emotional issues and that expressive writing helps resolve these issues. Sample topics included relationships or goals. They were told that their work would not be read and were asked to write continuously for the duration of the session about an emotionally important topic.
12080421|NCT00042172|Drug|Donepezil|
12080422|NCT00042172|Drug|Ginkgo Biloba Extract|
12080423|NCT00042159|Device|repetitive transcranial magnetic stimulation|1 Hertz stimulation for 16 minutes per day at 90% motor threshold, 5 sessions each to the two primary cortical targets
12080424|NCT00042146|Behavioral|Cognitive-behavior therapy|
12080425|NCT00042146|Drug|zolpidem|
12080426|NCT00042094|Biological|Cell-Cultured Smallpox Vaccine compared to Dryvax®|
12080427|NCT00042081|Drug|CGT003 (E2F Duplex Decoy)|
12080428|NCT00042068|Drug|Meloxicam|
12080429|NCT00042055|Drug|CP-461|
12080430|NCT00042042|Behavioral|Family based educational program|
12080431|NCT00042029|Drug|MK0869, aprepitant|
12080432|NCT00042029|Drug|Comparator: placebo|
12080433|NCT00042016|Drug|decitabine (5-aza-2'deoxycytidine)|
12080434|NCT00042003|Drug|decitabine (5-aza-2'deoxycytidine)|
12080435|NCT00041990|Drug|decitabine (5-aza-2'deoxycytidine)|
12080436|NCT00041977|Drug|doxycycline hyclate 20 mg twice daily|
12080437|NCT00041938|Drug|aspirin|325 mg per day
12080438|NCT00041938|Drug|Warfarin|INR 2.5-3.0; target INR 2.75
12080439|NCT00041925|Drug|CGT003 (E2F Duplex Decoy)|
12080440|NCT00041860|Procedure|Controlled Exposure to Environmental Contaminant|
12080441|NCT00041821|Procedure|Nasal irritation thresholds and irritant provocation|
12080442|NCT00041899|Drug|CDB-2914|
12080443|NCT00041899|Drug|COB-2914|
12080444|NCT00041808|Drug|MTC-DOX for Injection|
12080445|NCT00041808|Procedure|Chemotherapy|
12080446|NCT00041795|Drug|leteprinim potassium (Neotrofin)|
12080447|NCT00041782|Drug|Dalteparin (Fragmin)|200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU).
12080448|NCT00041769|Procedure|Therapeutic Drug Monitoring (TDM)|
12080449|NCT00041756|Drug|PG-530742|One 25 mg PG-530742 tablet, twice daily for for one year
12080450|NCT00041756|Drug|Placebo|One placebo tablet, twice daily for for one year
12080451|NCT00041756|Drug|50 mg PG-530742|One 50 mg PG-530742 tablet, twice daily for for one year
12080452|NCT00041756|Drug|100 mg PG-530742|100 mg PG-530742 tablet, twice a day for one year
12080453|NCT00041756|Drug|200 mg PG-530742|200 mg PG-530742 tablet, twice a day for one year
12080454|NCT00041743|Behavioral|Group Cognitive Behavioral Therapy|
12080455|NCT00041730|Biological|Id-KLH|
12080456|NCT00041717|Drug|Fampridine-SR|25mg bid (twice daily)
12080457|NCT00041717|Other|Placebo|Placebo
12080458|NCT00041704|Drug|Anidulafungin, VER002|
12080459|NCT00041691|Drug|hMN14 (labetuzumab)|
12080460|NCT00041678|Drug|aripiprazole|
12080461|NCT00041665|Drug|Recombinant Human Keratinocyte Growth Factor|
12080462|NCT00041652|Drug|hMN14 (labetuzumab)|
12080463|NCT00041639|Drug|hMN14 (labetuzumab)|
12080464|NCT00041626|Genetic|INGN 201|
12080465|NCT00041613|Genetic|INGN 201|
12080466|NCT00041587|Drug|IL13-PE38QQR|
12080467|NCT00041587|Procedure|targeted fusion protein therapy|
12080468|NCT00041587|Procedure|surgery|
12080469|NCT00041509|Drug|SB-424323|500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
12080470|NCT00041509|Drug|Placebo|matching placebo, oral, BID for 28 days
12080471|NCT00041496|Drug|SB-207266|White, oval, biconvex tablets containing either 10mg, 25mg or 40mg
12080472|NCT00041496|Other|Placebo|Placebo to match SB-207266
12080473|NCT00041574|Drug|Inhaled Nitric Oxide|Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments).
12080474|NCT00041561|Drug|Nitrogen gas|Nitrogen gas will be given at 5ppm until Day 28 or extubation
12080475|NCT00041561|Drug|inhaled nitric oxide|inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
12080476|NCT00041548|Drug|nitric oxide for inhalation|given at 20 ppm for 1 hour then weaned off over 4 hours
12080477|NCT00041548|Drug|Oxygen|given at 20 ppm for one hour, then weaned off over four hours
12080478|NCT00041535|Drug|OGT 918|
12080479|NCT00041470|Drug|Paclitaxel|50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
12080480|NCT00041470|Drug|Vinorelbine|20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
12080481|NCT00041470|Drug|Herceptin|4 mg/kg IV loading dose day 1 of first week followed by 2 mg/kg IV maintenance dose on each subsequent week. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
12080482|NCT00041470|Drug|Filgrastim|5 mcg/kg daily including the day of IV chemotherapy. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
12080483|NCT00040677|Drug|Low Dose ICA-17043|Low dose arm
12080484|NCT00040677|Drug|High dose ICA-17043|150 mg Loading Dose; 10 mg daily dose
12080485|NCT00040677|Drug|Placebo|Placebo Loading dose capsules and maintenance dose tablets matched 10 mg active treatment group
12080486|NCT00040664|Drug|ritonavir|ritonavir oral capsules or oral solution
12080487|NCT00040664|Drug|fosamprenavir|fosamprenavir oral suspension or tablet
12080488|NCT00040651|Drug|Fludarabine|
12080489|NCT00040651|Drug|Cyclophosphamide|
12080490|NCT00040651|Drug|Thymoglobulin|
12080491|NCT00040651|Procedure|Leukapheresis|
12080492|NCT00040651|Procedure|Self bone marrow transplant|
12080493|NCT00041431|Drug|Hormone Replacement Therapy|
12080494|NCT00041392|Drug|Magnesium|100 mg/kg
12080495|NCT00041392|Drug|0.9% saline|Placebo
12080496|NCT00040638|Drug|TLK286|
12080497|NCT00040625|Drug|Pemetrexed|
12080498|NCT00040625|Drug|Cisplatin|
12080499|NCT00040027|Drug|thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a|
12080500|NCT00040027|Drug|placebo + PEGinterferon alfa-2a|
12080501|NCT00040599|Drug|hMN14 (labetuzumab)|
12080502|NCT00040586|Drug|Monoclonal Antibody J591|
12080503|NCT00040586|Drug|Recombinant Interleukin-2|
12080504|NCT00040573|Drug|131I-TM-601|
12080505|NCT00040560|Drug|111In-DAC|
12080506|NCT00040560|Procedure|Diagnostic|
12080507|NCT00040547|Drug|Farnesyl Protein Transferase Inhibitor|
12080508|NCT00040534|Drug|Farnesyl Protein Transferase Inhibitor|
12080509|NCT00040521|Drug|Recombinant Human Interleukin-11 (rhIL-11)|
12080510|NCT00040495|Drug|Pantoprazole|
12080511|NCT00040482|Drug|Cyclophosphamide|
12080512|NCT00040482|Drug|ATG|
12080513|NCT00040482|Drug|MESNA|
12080514|NCT00040482|Procedure|Radiation therapy|
12080515|NCT00040469|Drug|Campath -1H|
12080516|NCT00040469|Drug|Dilantin|
12080517|NCT00040469|Drug|Busulfan|
12080518|NCT00040469|Drug|Cyclophosphamide|
12080519|NCT00040456|Drug|Mg Pidolate|Mag 2 will be used (magnesium pidolate, a granular powder, containing 0.184 g of Mg/packet, equal to 7.6 mmol or 15.2 meq Mg), since this preparation has less side effects such as diarrhea than other Mg preparations. The study medication will be a liquid containing 0.6 meq Mg pidolate/kg body weight per day, divided into 2 daily doses. The Mg pidolate (45 g) will be distributed as a pre-mixed powder containing Koolaid Tropical Punch powder (9 gm), and sucrose (67 gm).
12080520|NCT00040456|Drug|Placebo|The study medication will be a liquid containing an equivalent amount of placebo to the study medication, divided into 2 daily doses.The placebo will have the same amount of sucrose and Tropical Punch powder as the study drug, MG Pidolate, as well as 45 g of lactose. Subjects will continue with the same assignment for 6 months and then switch to the other arm (after a 2-month wash-out period).
12080521|NCT00040443|Drug|CX516|
12080522|NCT00040443|Drug|Placebo|
12080523|NCT00040430|Drug|111In-DAC|
12080524|NCT00040430|Procedure|Diagnostic|
12080525|NCT00040508|Drug|Sirolimus|
12080526|NCT00040417|Drug|FLUDARABINE|
12080527|NCT00040417|Drug|CAMPATH-IH|
12080528|NCT00040417|Procedure|Total Body Irradiation|
12080529|NCT00040417|Drug|FK506|
12080530|NCT00040417|Drug|G-SCF (Granulocyte-colony stimulating factor)|
12080531|NCT00040404|Drug|CEP-1347 10mg|CEP-1347 10mg, a K252a derivative, retains neuroprotective properties
12080532|NCT00040404|Drug|CEP1347 25mg|CEP1347 25mg, a K252a derivative, retains neuroprotective properties
12080533|NCT00040404|Drug|CEP-1347 50mg|CEP-1347 50mg, a K252a derivative, retains neuroprotective properties
12080534|NCT00040404|Other|Placebo Comparator|Placebo capsules matching the CEP-1347 capsules
12080535|NCT00040391|Drug|Investigational drug|
12080536|NCT00040391|Drug|Irinotecan|
12080537|NCT00040391|Drug|5-fluorouracil|
12080538|NCT00040391|Drug|Leucovorin|
12080539|NCT00040378|Drug|alphatocopherol|400 IU daily
12080540|NCT00040378|Drug|Selenium|200mcg daily
12080541|NCT00040378|Drug|Placebo replacement for vitamin E|1 placebo pill daily
12080542|NCT00040378|Drug|Placebo replacement for Selenium|1 placebo pill daily
12080543|NCT00040365|Drug|Amifostine trihydrate|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
12080544|NCT00040365|Radiation|Radiation therapy|The treatment will be delivered in at least two phases. The first field reduction will occur after 46Gy and the second field reduction will occur after 70Gy.
12080545|NCT00040339|Procedure|hypothermia (body temperature lowered to 33°C or 91.4°F)|
12080546|NCT00040326|Procedure|anteromesial temporal resection|surgical treatment for epilepsy
12080547|NCT00040326|Drug|antiepileptic drugs|pharmacotherapy
12080548|NCT00040313|Drug|pegaptanib sodium (Macugen)|
12080549|NCT00040300|Drug|Racivir|
12080550|NCT00040287|Behavioral|smoking cessation program|
12080551|NCT00040287|Behavioral|weight control program|
12080552|NCT00040274|Drug|DPC 817|
12080553|NCT00040183|Drug|Tarceva (erlotinib HCl, OSI-774)|
12080554|NCT00040170|Biological|MVA-MUC1-IL2|
12080555|NCT00040157|Drug|ACH126-443 (Beta-L-Fd4C)|
12080556|NCT00040144|Drug|ACH126, 433 (b-L-Fd4C)|
12080557|NCT00040261|Drug|Memantine HCL|
12080558|NCT00040248|Drug|Daclizumab|
12080559|NCT00040235|Procedure|magnesium|
12080560|NCT00040209|Drug|JP 1730|
12080561|NCT00040209|Drug|IV Levodopa|
12080562|NCT00040209|Drug|IV Apomorphine|
12080563|NCT00040131|Drug|IL-10|
12080564|NCT00040105|Drug|Zarnestra (R115777)|"Starting Dose:
~300 mg by mouth (PO) Twice daily"
12080565|NCT00040105|Drug|Gleevec (Imatinib mesylate)|"Starting Dose:
~300 mg By Mouth (PO) daily"
12080566|NCT00040092|Drug|Virulizin®|
12080567|NCT00040014|Drug|exemestane|
12080568|NCT00040001|Drug|DTI-0009|
12080569|NCT00039988|Drug|Glatiramer acetate|20 mg administered subcutaneously daily
12080570|NCT00039988|Drug|Albuterol|2 mg or 4 mg oral capsules taken daily
12080571|NCT00039988|Drug|Albuterol placebo|Oral placebo capsules will be taken daily
12080572|NCT00039975|Drug|Indinavir sulfate|
12080573|NCT00039975|Drug|Ritonavir|
12080574|NCT00039975|Drug|Amlodipine|
12080575|NCT00039975|Drug|Diltiazem HCl|
12080576|NCT00039962|Drug|thymalfasin (thymosin alpha 1)|
12080577|NCT00039962|Drug|PEGinterferon alfa-2a|
12080578|NCT00039936|Behavioral|Cognitive Behavior Treatment|
12080579|NCT00039936|Behavioral|Self Help|
12080580|NCT00039936|Behavioral|Partial Self Help|
12080581|NCT00040066|Procedure|Cocaine (IV)|
12080582|NCT00040053|Drug|Ondansetron|
12080583|NCT00040040|Drug|Bupropion|
12080584|NCT00039910|Drug|(PN-152,243)/ PN-196,444|
12080585|NCT00039884|Drug|NESP - Novel Erythropoiesis Stimulating Protein|
12080586|NCT00039871|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks
12080587|NCT00039871|Drug|REBETOL (ribavirin; SCH 18908)|REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks
12080588|NCT00039858|Drug|Argatroban|
12080589|NCT00039832|Drug|Abciximab (ReoPro) and Reteplase (Retavase)|
12080590|NCT00039793|Procedure|Moderate-intensity and low-intensity bodywork therapy|
12080591|NCT00039780|Drug|BNP7787|The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
12080592|NCT00039780|Drug|Placebo|The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
12080593|NCT00039754|Drug|Holmium-166-DOTMP|
12080594|NCT00039741|Drug|NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT)|Accepted NRTIs: abacavir sulfate (ABC), emtricitabine (FTC), emtricitabine/Tenofovir disoproxil fumarate (FTC/TDF), lamivudine (3TC), lamivudine/zidovudine (3TC/AZT), stavudine (d4T), tenofovir disoproxil fumarate (TDF), zalcitabine (ddC), zidovudine (AZT) Prescribed per participant's doctor
12080595|NCT00039741|Drug|NNRTIs (EFV, NVP)|"Accepted NNRTIs: efavirenz (EFV), nevirapine (NVP)
~Prescribed per participant's doctor"
12080596|NCT00039741|Drug|PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)|"Accepted PIs: amprenavir (APV). indinavir sulfate (IDV), lopinavir/ritonavir (LPV/r), nelfinavir mesylate (NFV), saquinavir (SQV), ritonavir (RTV)
~Prescribed per participant's doctor"
12080597|NCT00039767|Drug|Lepirudin|
12080598|NCT00039026|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
12080599|NCT00039026|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
12080600|NCT00039026|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
12080601|NCT00039026|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
12080814|NCT00037440|Genetic|Polymorphisms measured|
12080815|NCT00037219|Drug|Anidulafungin, VER002|
12080602|NCT00039013|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
12080603|NCT00039013|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
12080604|NCT00039013|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
12080605|NCT00039013|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
12080606|NCT00039000|Drug|HSPPC-96 or Oncophage|
12080607|NCT00038987|Biological|Wetvax (APSV)|
12080608|NCT00038974|Drug|peginterferon alfa-2a|
12080609|NCT00038974|Drug|Ribavirin|
12080610|NCT00038961|Drug|fondaparinux sodium|2.5 mg fondparinux sodium, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)
12080611|NCT00038961|Other|placebo|placebo, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)
12080612|NCT00039702|Drug|[123] 5-I-A-85380|
12080613|NCT00039663|Drug|Pravastatin|
12080614|NCT00039663|Drug|Gemfibrozil|
12080615|NCT00039663|Drug|Rosiglitazone|
12080616|NCT00039624|Radiation|Brachytherapy|Patients will receive two HDR brachytherapy implants (950-1050 cGy/implant) before and at the end of a course of external beam radiotherapy (4600 cGy, 2Gy/day).
12080617|NCT00038948|Drug|Sirolimus|Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
12080618|NCT00038948|Drug|tacrolimus|
12080619|NCT00038948|Drug|Cyclosporine A|
12080620|NCT00038935|Drug|ReFacto AF|
12080621|NCT00038922|Drug|rhIL-11|
12080622|NCT00038909|Drug|BDDrFVII|
12080623|NCT00038896|Drug|Venlafaxine ER|
12080624|NCT00038883|Drug|Campath-1H|10 mg/day x 5, starting with the first day of chemotherapy
12080625|NCT00038870|Biological|Dendritic Cell Activated Lymphocyte|
12080626|NCT00038857|Procedure|Megadose of CD34 Selected Progenitor Cells|Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0.
12080627|NCT00038857|Drug|Melphalan|140 mg/m^2 on day -8
12080628|NCT00038857|Drug|Thiotepa|10 mg/kg on day -7
12080629|NCT00038857|Drug|Fludarabine|160 mg/m^2 over 4 days on days -6, -5, -4, -3
12080630|NCT00038857|Drug|Rabbit ATG|1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.
12080631|NCT00038844|Drug|Campath-1 H (Alemtuzumab)|Starting Dose of 15 mg by vein daily, 3 days in a row.
12080632|NCT00038844|Drug|Fludarabine|30 mg/m2 by vein daily, 3 days in a row.
12080633|NCT00038844|Drug|Cyclophosphamide|1 gm/m2 by vein daily, 3 days in a row.
12080634|NCT00038844|Drug|Rituximab|375 mg/m2 by vein, given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.
12080635|NCT00038831|Drug|Mylotarg|Starting dose 2 mg/m^2 over 2-hour intravenous infusion on day -12.
12080636|NCT00038831|Drug|Fludarabine|30 mg/m^2 will be given intravenously daily at the same time over 30 minutes on days -5, -4, -3, -2.
12080637|NCT00038831|Drug|Melphalan|140 mg/m^2 will be given intravenously over 20 minutes starting 2 hours after the beginning of the fludarabine infusion on day -2.
12080638|NCT00038831|Drug|Anti-thymocyte globulin|Patients with an unrelated or mismatched related donor will receive 0.5 mg/kg on day -3 and 1.25 mg/Kg on days -2 and -1, following the chemotherapy.
12080639|NCT00038831|Procedure|Stem cell transplant|Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation: Infusion of blood stem cells or bone marrow cells on day 0.
12080640|NCT00038818|Biological|CD8 Depleted Donor Lymphocyte|
12080641|NCT00038805|Drug|Mylotarg|
12080642|NCT00038792|Drug|Recombinant Human Keratinocyte Growth Factor|
12080643|NCT00038779|Procedure|Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation|
12080644|NCT00038766|Drug|semapimod|semapipmod 60 mg IV x 5 days
12080645|NCT00038766|Drug|semapimod|IV 30 mg x 5 days
12080646|NCT00038766|Drug|placebo|placebo IV
12080647|NCT00038753|Procedure|Vision Screening|
12080648|NCT00038727|Behavioral|DPPOS Group Lifestyle|Quarterly group lifestyle sessions
12080649|NCT00038727|Drug|Metformin|Administered as 850mg twice per day, masked in DPP and open label in DPPOS
12080650|NCT00038727|Behavioral|DPPOS Boost Lifestyle|In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
12080651|NCT00038727|Behavioral|Intensive Lifestyle Group Session|16 session curriculum in group format. In DPP delivered to ILS as individual sessions
12080652|NCT00038714|Drug|SGN-00101|
12080653|NCT00038701|Drug|TNP-470|
12080654|NCT00038688|Behavioral|Peer HIV Education Program|
12080655|NCT00038675|Drug|Imatinib Mesylate (Gleevec)|Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily
12080656|NCT00038662|Drug|Atrasentan|
12080657|NCT00038649|Drug|Gleevec|400 mg orally twice daily
12080658|NCT00038636|Drug|Lopinavir/ritonavir|
12080659|NCT00038636|Drug|Ritonavir|
12080660|NCT00038623|Drug|Yttrium-ibritumomab (Zevalin)|After Rituximab infusion, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
12080661|NCT00038623|Drug|Rituximab|250 mg/m^2 in the vein over 6 to 8 hours on Day 1.
12080662|NCT00038610|Drug|Imatinib Mesylate|600 mg by mouth on days 1 - 14 for course 1, and 600 mg by mouth daily days 1-14 (or daily if tolerated with course 1) for courses 2, 4, 6, 8.
12080663|NCT00038610|Drug|Cyclophosphamide|300 mg/m^2 by vein every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m^2) for courses 1, 3, 5, 7.
12080664|NCT00038610|Drug|Doxorubicin|50 mg/m^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7.
12080665|NCT00038610|Drug|Vincristine|2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7.
12080666|NCT00038610|Drug|Dexamethasone|40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7.
12080667|NCT00038610|Drug|Methotrexate|"12 mg intrathecally (6 mg if via Ommaya reservoir) day 2 for courses 1, 3, 5, 7.
~200 mg/m^2 by vein over 2 hours followed by 800 mg/m^2 over 22 hours on day 1 of courses 2, 4, 6, 8."
12080668|NCT00038610|Drug|Cytarabine|"100 mg intrathecally day 7 for courses 1, 3, 5, 7.
~3 gm/m2 by vein over 2 hrs every 12 hrs for 4 doses on days 2 and 3 for courses 2, 4, 6, 8."
12080669|NCT00038610|Drug|Mesna|600 mg/m^2 by vein daily for 24 hours for courses 1, 3, 5, 7.
12080670|NCT00038610|Drug|G-CSF|10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
12080671|NCT00038597|Drug|SCH66336|
12080672|NCT00038584|Drug|SCH66336|
12080673|NCT00038571|Drug|PS341 (Bortezomib)|1.5 mg/m2 intravenous (IV) bolus push over 3 to 5 seconds on days 1, 4, 8, and 11, followed by a 10-day rest for a 21-day cycle.
12080674|NCT00038558|Drug|Filgrastim SD/01|
12080675|NCT00038558|Drug|Adriamycin|
12080676|NCT00038558|Drug|Bleomycin|
12080677|NCT00038558|Drug|Vinblastine|
12080678|NCT00038558|Drug|DTIC|
12080679|NCT00038545|Drug|Filgrastim SD/01|
12080680|NCT00038545|Drug|Paclitaxel|
12080681|NCT00038545|Drug|Topotecan|
12080682|NCT00038532|Drug|Amprenavir/ritonavir|
12080683|NCT00038532|Drug|Saquinavir/ritonavir|
12080684|NCT00038532|Drug|Efavirenz|
12080685|NCT00038519|Drug|Amprenavir/ritonavir|
12080686|NCT00038519|Drug|Saquinavir/ritonavir|
12080687|NCT00038506|Drug|abacavir/lamivudine/zidovudine|
12080688|NCT00038506|Drug|tenofovir|
12080689|NCT00038493|Drug|Temozolomide and SCH66336|
12080690|NCT00038480|Drug|Lopinavir/Ritonavir|
12080691|NCT00038467|Drug|Tamoxifen|Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
12080692|NCT00038467|Drug|Exemestane|Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
12080693|NCT00038454|Drug|Hemolink (hemoglobin raffimer IV solution)|
12080694|NCT00038441|Drug|DTI-015|DTI-015 injected through a catheter into center of brain tumor.
12080695|NCT00038428|Drug|TLK286|
12080696|NCT00038415|Biological|CLL vaccine using DNA plasmid vector|
12080697|NCT00038402|Drug|Herceptin|Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses.
12080698|NCT00038402|Drug|Taxol|225 mg/m^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.
12080699|NCT00038402|Drug|Fluorouracil|500 mg/m^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.
12080700|NCT00038402|Drug|Cytoxan|500 mg/m^2 on Day 1 of each cycle for 4 cycles.
12080701|NCT00038402|Drug|Epirubicin|75 mg/m^2 IV on Day 1 of each cycle for 4 cycles.
12080702|NCT00038389|Drug|Vioxx|Starting dose for patients age 3-14 years 10.0 mg/1.73 m2 and for patients above 14 years of age 12.5 mg for 5 days per week for 6 weeks during radiation treatment, and 7 days per week for 6 months after radiation treatment.
12080703|NCT00038376|Drug|Isotretinoin (Accutane)|0.5 mg/k (1.0 mg/k total) by mouth twice a day
12080704|NCT00038376|Drug|Interferon Alpha|Starting dose of 3 MU injected under skin once a day for 12 weeks.
12080705|NCT00038363|Procedure|Rehabilitation|
12080706|NCT00038363|Procedure|Subacute care|
12080707|NCT00038350|Behavioral|Lingual Strengthening|8 week lingual strengthening exercise protocol
12080708|NCT00038337|Procedure|Health Literacy|
12080709|NCT00038311|Drug|PN-152,243)/PN-196,444|
12080710|NCT00038298|Drug|Placebo|Placebo given 3 times weekly
12080711|NCT00038298|Drug|AMG 719|50 mg 3 times weekly
12080712|NCT00038298|Drug|AGM 719|200 mg 3 times weekly
12080713|NCT00038298|Drug|AMG 719|400 mg 3 times weekly
12080714|NCT00038298|Drug|placebo to AMG 719|Placebo dose given 3 times weekly
12080715|NCT00038285|Procedure|Amputation Prevention|
12080716|NCT00038272|Drug|Mycophenolate mofetil|
12080717|NCT00038272|Drug|Amdoxovir|
12080718|NCT00038259|Drug|Aldesleukin|
12080719|NCT00038246|Drug|Estramustine|140 mg by mouth (po) three times a day on Days 1-5, 8-12
12080720|NCT00038246|Drug|Thalidomide|200 mg by mouth every day once a week with dose escalation every week if no dose limiting toxicity.
12080721|NCT00038246|Drug|Paclitaxel (Taxol)|100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10
12080722|NCT00038233|Drug|Thalidomide|200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion)
12080723|NCT00038220|Drug|Lopinavir/ritonavir|
12080724|NCT00038220|Drug|Efavirenz|
12080725|NCT00038220|Drug|Lamivudine|
12080726|NCT00038220|Drug|Tenofovir DF|
12080727|NCT00038207|Drug|Liposomal Vincristine|Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days
12080728|NCT00038194|Drug|imatinib mesylate|
12080729|NCT00038194|Drug|docetaxel|
12080730|NCT00038181|Drug|Thalidomide|
12080731|NCT00038168|Drug|Estramustine|Intravenous dose
12080732|NCT00038168|Drug|Taxol|Intravenous dose
12080733|NCT00038155|Procedure|Ambulation training|Recruitment of eligible subjects, ambulatory and resistance training in hospital and post-discharge
12080734|NCT00038142|Drug|Vincristine|2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.
12080735|NCT00038142|Drug|Doxorubicin|90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6.
12080736|NCT00038142|Drug|Cyclophosphamide|2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6.
12080737|NCT00038142|Drug|Dexrazoxane|900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.
12080738|NCT00038142|Biological|ImmTher|900 mcg/m^2 IV over 1 hour every week x 50-52 weeks.
12080739|NCT00038129|Procedure|Intramedullary nail implant|Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
12080816|NCT00037206|Drug|Anidulafungin, VER002|
12080817|NCT00037180|Drug|Celecoxib|
12080818|NCT00037180|Drug|Irinotecan|
12080740|NCT00038116|Procedure|embryonic dopamine cell implant surgery|Half of the participants received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants.
12080741|NCT00038116|Procedure|placebo|sham surgery
12080742|NCT00038103|Drug|Exemestane|Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
12080743|NCT00038103|Drug|Celecoxib + Exemestane|Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.
12080744|NCT00038090|Drug|Thalidomide|100 mg capsules by mouth daily each evening
12080745|NCT00038090|Drug|Dexamethasone|20 mg/m^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.
12080746|NCT00038077|Drug|Seloken ZOK/Toprol-XL|50 mg
12080747|NCT00038077|Drug|Seloken ZOK/Toprol-XL|200 mg
12080748|NCT00038077|Drug|Placebo|
12080749|NCT00038064|Drug|Darbepoetin alfa|Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.
12080750|NCT00038064|Drug|rHuEPO|150 IU/kg TIW
12080751|NCT00038051|Drug|Hum-195/rGel|Starting Dose = 3 mg/m^2 twice weekly for 2 weeks.
12080752|NCT00038038|Drug|18F-fluoromisonidazole|Small amount of radioactive traces drug given by intravenous injection prior to PET Scan
12080753|NCT00038038|Procedure|PET scan|Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection
12080754|NCT00038025|Drug|Deoxycoformycin (DCF)|Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.
12080755|NCT00038012|Drug|Thrombopoietin|
12080756|NCT00038012|Procedure|Platelet-pheresis|
12080757|NCT00038012|Drug|Carboplatin|
12080758|NCT00037999|Procedure|Testosterone supplement|
12080759|NCT00037986|Device|Hearing Aids|Hearing aid use
12080760|NCT00037973|Behavioral|ventilation feedback|
12080761|NCT00037973|Behavioral|exercise|
12080762|NCT00037960|Procedure|Constrained Induced Therapy|
12080763|NCT00037947|Procedure|Hearing in Multiple Sclerosis|
12080764|NCT00037934|Device|Upper extremity robot|Robotic upper extremity neuro-rehabilitation
12080765|NCT00037934|Other|Traditional Supervised Upper Extremity Exercises|Arm ergometer, reaching, and stretching exercises
12080766|NCT00037921|Procedure|Bacterial colonization|
12080767|NCT00037908|Procedure|Strength training|
12080768|NCT00037895|Procedure|Ambulation training|
12080769|NCT00037882|Drug|PEG-Intron|Once weekly injection.
12080770|NCT00037869|Drug|I-131 Metaiodobenzylguanidine|
12080771|NCT00037843|Drug|I-131 Iodocholesterol|
12080772|NCT00037830|Drug|GM1 ganglioside|100 mg twice per day by subcutaneous injection
12080773|NCT00037830|Drug|Placebo|Twice per day subcutaneous injection, equal volume as active drug
12080774|NCT00037817|Drug|Decitabine|assigned dose level on day 4 and day 10 of each 34 day cycle
12080775|NCT00037817|Biological|Depsipeptide|assigned dose level on day 4 and day 10 of each 34 day cycle
12080776|NCT00037817|Drug|Celecoxib|400mg PO BID on days 4 through 34 of each cycle
12080777|NCT00037804|Drug|Irinotecan|
12080778|NCT00037791|Drug|(PN-152,243)/PN-196,444|
12080779|NCT00004575|Drug|Miconazole, L-NMMA, Bradykinin|
12080780|NCT00001866|Procedure|horizontal muscles of the eye will be cut and then reattached in the same position|
12080781|NCT00001864|Drug|Atropine|
12080782|NCT00001864|Device|Patch|
12080783|NCT00001818|Drug|Hydroxyurea|
12080784|NCT00001688|Drug|Ritonavir|
12080785|NCT00001688|Drug|Nevirapine|
12080786|NCT00001688|Drug|Stavudine|
12080787|NCT00001542|Drug|fluconazole|
12080788|NCT00001190|Drug|Deslorelin|
12080789|NCT00037752|Drug|Sibutramine|At the baseline study visit, participants in Group 1 will be given a one month supply of 5 mg/d of sibutramine and a 1-month follow-up visit will be scheduled. After a safety evaluation at the 1-month follow-up visit, participants will have their dose of sibutramine titrated to 10 mg/d, a 1 month supply of the medication will be given to participants, and a 2-month follow-up visit will be scheduled. After a safety evaluation at the 2-month follow-up visit, participants will receive a 1 month supply of sibutramine 10 mg/d and a 3-month follow-up visit will be scheduled. At the 3-month follow-up visit, the sibutramine will be discontinued and participants will be scheduled for 4- and 5-month follow-up visits.
12080790|NCT00037752|Behavioral|Behavioral Smoking Cessation Program|Both groups of participants will take part in a behavioral smoking cessation program.
12080791|NCT00037713|Biological|BEC2 Vaccine|5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10.
12080792|NCT00037700|Drug|anakinra|
12080793|NCT00037700|Drug|pegsunercept|
12080794|NCT00037687|Drug|rPAF-AH|
12080795|NCT00037674|Drug|Topiramate|
12080796|NCT00037661|Drug|INS365 Ophthalmic Solution|
12080797|NCT00037648|Drug|Anakinra|anakinra
12080798|NCT00037648|Drug|Placebo|placebo
12080799|NCT00037635|Drug|AMG 073|30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
12080800|NCT00037635|Drug|Placebo|30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
12080801|NCT00037622|Drug|ACH-126, 443 (beta-L-Fd4C)|
12080802|NCT00037609|Drug|Capecitabine|1000 mg/m^2 taken by mouth twice daily.
12080803|NCT00037609|Drug|Exisulind|125 mg taken by mouth twice daily.
12080804|NCT00037596|Drug|Gemtuzumab Ozogamicin|
12080805|NCT00037596|Drug|cytarabine.|
12080806|NCT00037583|Drug|Gemtuzumab Ozogamicin|
12080807|NCT00037570|Drug|Pantoprazole|
12080808|NCT00037557|Drug|BeneFIX|
12080809|NCT00037544|Drug|ReFacto AF|
12080810|NCT00037531|Drug|Sirolimus (RAPAMUNE)|
12080811|NCT00037518|Drug|AMG 073|
12080812|NCT00037492|Procedure|home-based sessions/family meetings with trained clinician|
12080813|NCT00037479|Drug|ceftriaxone|
12080830|NCT00037089|Drug|UFT (Tegafur/Uracil)|
12080831|NCT00037063|Drug|Thiamine hydrochloride|
12080832|NCT00037063|Drug|Riboflavin|
12080833|NCT00037063|Drug|Ascorbic acid|
12080834|NCT00037063|Drug|Vitamin E|
12080835|NCT00037050|Drug|Linezolid|
12080836|NCT00037050|Drug|Vancomycin|
12080837|NCT00037050|Drug|Oxacillin|
12080838|NCT00037050|Drug|Dicloxacillin|
12080839|NCT00036647|Drug|Tarceva (erlotinib HCl, OSI-774 )|
12080840|NCT00036634|Drug|Tenofovir DF|Tenofovir DF tablet administered orally once daily
12080841|NCT00036634|Drug|Tenofovir alafenamide|Tenofovir alafenamide tablet(s) administered orally once daily
12080842|NCT00036621|Drug|BMS-275291|
12080843|NCT00036608|Drug|Entecavir|
12080844|NCT00036582|Drug|Clozapine|
12080845|NCT00036569|Procedure|adjuvant therapy|
12080846|NCT00036569|Biological|pegylated interferon alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
12080847|NCT00036556|Drug|Atrasentan|
12080848|NCT00036543|Drug|Atrasentan|
12080849|NCT00036517|Drug|PHY906|
12080850|NCT00036504|Drug|Insulin Lispro low mixture|
12080851|NCT00036491|Drug|Rituximab|Subjects received four weekly infusions of rituximab at a dose of 375 mg/m^2
12080852|NCT00036465|Behavioral|Treatment regimen change|
12080853|NCT00036452|Drug|lopinavir/ritonavir|
12080854|NCT00036452|Drug|emtricitabine|
12080855|NCT00036452|Drug|stavudine|
12080856|NCT00036452|Drug|tenofovir DF|
12080857|NCT00036439|Drug|Infliximab|
12080858|NCT00036426|Biological|FavId (Id-KLH) active immunotherapy|
12080859|NCT00036413|Drug|TCH346|
12080860|NCT00036400|Drug|epoetin alfa|
12080861|NCT00036387|Drug|Infliximab|
12080862|NCT00036374|Drug|Infliximab|
12080863|NCT00036361|Drug|Aripiprazole|
12080864|NCT00036348|Drug|Aripiprazole|
12080865|NCT00036335|Drug|Duloxetine Hydrochloride|
12080866|NCT00036309|Drug|Duloxetine Hydrochloride|
12080867|NCT00036296|Drug|talampanel|75mg per day divided into 3 doses for 22 days
12080868|NCT00036283|Drug|Celecoxib|
12080869|NCT00036270|Drug|exemestane (Aromasin)|exemestane, orally, 25 mg, for 5 years
12080870|NCT00036270|Drug|tamoxifen + exemestane|tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
12080871|NCT00036257|Drug|CP-461|
12080872|NCT00036244|Drug|RG1068 (Synthetic Human Secretin)|
12080873|NCT00036231|Drug|RG1068 (Synthetic Human Secretin)|
12080874|NCT00036218|Drug|sumanirole|
12080875|NCT00036218|Drug|ropinirole|
12080876|NCT00036205|Drug|sumanirole|
12080877|NCT00036192|Drug|FK614|
12080878|NCT00036179|Drug|FK463|
12080879|NCT00036166|Drug|FK463|
12080880|NCT00036153|Drug|Tacrolimus (Prograf®)|
12080881|NCT00036153|Drug|Methotrexate|
12080882|NCT00036140|Drug|Investigational drug|
12080883|NCT00036127|Drug|aripiprazole|
12080884|NCT00036114|Drug|aripiprazole|
12080885|NCT00036101|Drug|aripiprazole|
12080886|NCT00036088|Drug|Olanzapine|
12080887|NCT00036075|Drug|CP-461|
12080888|NCT00036062|Drug|Sivelestat|
12080889|NCT00036036|Drug|CP-461|
12080890|NCT00036023|Drug|darbepoetin alfa|
12080891|NCT00035997|Drug|Zometa|
12080892|NCT00035984|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
12080893|NCT00035984|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
12080894|NCT00035984|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
12080895|NCT00035984|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
12080896|NCT00035971|Drug|raloxifene HCI and alendronate Na|
12080897|NCT00035958|Drug|Prednisone|
12080898|NCT00035958|Drug|Methotrexate|
12080899|NCT00035958|Drug|Etanercept|
12080900|NCT00035945|Drug|ISIS 14803|
12080901|NCT00035932|Drug|Atazanavir + ritonavir + tenofovir + nucleoside|Active Comparator, Capsules, tablets, Oral
12080902|NCT00035932|Drug|Atazanavir + saquinavir + tenofovir + nucleoside|Active Comparator, Capsules, tablets, Oral
12080903|NCT00035932|Drug|Lopinavir/ritonavir + tenofovir + nucleoside|Active Comparator, Capsules, tablets, Oral
12080904|NCT00035919|Genetic|Mx-dnG1 Retroviral Vector|
12080905|NCT00035906|Drug|DEX PS DDS®|
12080906|NCT00035893|Drug|poly I-poly C12U|200-400 mg IV infusions 2x/week for 64 weeks
12080907|NCT00035880|Drug|ABX-CBL|
12080908|NCT00035867|Drug|TLK199 HCl Liposomes for Injection|
12080909|NCT00035854|Drug|Zyvox® / Linezolid|
12080910|NCT00035841|Drug|TLK286|
12080911|NCT00035828|Drug|ABX-IL8|
12080912|NCT00035815|Drug|Insulin like growth factor, type 1|0.05 mg per kg body weight given subcutaneously twice daily
12080913|NCT00035815|Drug|Placebo|The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.
12080914|NCT00035802|Drug|Topiramate|"Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.
~OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months."
12080915|NCT00035802|Drug|Placebo|Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.
12080916|NCT00035789|Drug|Entecavir|
12080917|NCT00035633|Drug|Entecavir|
12080918|NCT00035620|Drug|pegfilgrastim|pegfilgrastim
12080919|NCT00035620|Drug|filgrastim|filgrastim
12080920|NCT00035607|Drug|Darbepoetin alfa SC|Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
12080921|NCT00035607|Drug|Darbepoetin alfa IV|Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
12080922|NCT00035594|Drug|pegfilgrastim|Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
12080923|NCT00035581|Drug|poly I-poly C12U|200-400 mg IV infusions 2x/week for 24 weeks
12080924|NCT00035568|Drug|Glucovance (metformin HCl/glyburide)|
12080925|NCT00035568|Drug|or Metformin HCl alone|
12080926|NCT00035568|Drug|or Glyburide alone.|
12080927|NCT00035555|Drug|Belatacept|Solution, intravenous
12080928|NCT00035555|Drug|Cyclosporine|Oral, capsule
12080929|NCT00035555|Drug|Mycophenolate mofetil (MMF)|Oral, capsule
12080930|NCT00035555|Drug|Corticosteroids|Corticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily
12080931|NCT00035542|Drug|Glucovance (metformin HCl/glyburide)|
12080932|NCT00035542|Drug|metformin HCl|
12080933|NCT00035542|Drug|glyburide|
12080934|NCT00035529|Drug|Placebo|Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.
12080935|NCT00035529|Drug|BMS 188667 (Abatacept)|Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
12080936|NCT00035529|Drug|BMS 188667 (Abatacept)|Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
12080937|NCT00035516|Drug|Epothilone|
12080938|NCT00035503|Drug|etiprednol dicloacetate|
12080939|NCT00035490|Drug|Azimilide Dihydrochloride|125 mg azimilide, once a day for one year
12080940|NCT00035490|Drug|placebo|placebo tablet, once daily for one year
12080941|NCT00035490|Drug|Azimilide Dihydrochloride|75 mg azimilide, once a day for one year
12080942|NCT00035477|Drug|Azimilide Dihydrochloride|125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
12080943|NCT00035477|Drug|Placebo|placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
12080944|NCT00035464|Drug|Azimilide Dihydrochloride|125 mg azimilide tablets, twice a day for 6 months
12080945|NCT00035464|Drug|Placebo|placebo tablets, twice a day for 6 months
12080946|NCT00035451|Drug|Azimilide Dihydrochloride|125 mg azimilide tablets, twice a day for 6 months
12080947|NCT00035451|Drug|Placebo|tablets, twice daily for 6 months
12080948|NCT00035451|Drug|Sotalol|160 mg sot twice daily for 6 months
12080949|NCT00035438|Drug|St. John's Wort|
12080950|NCT00035425|Drug|linezolid|600mg every 12 hours
12080951|NCT00035425|Drug|vancomycin|1gm every 12 hours. The dose of vancomycin intravenously may be adjusted for renal function, but the patient must be able to receive a 300 mL volume of intravenous fluid at the assigned dosing times of every 12 hours.
12080952|NCT00035412|Drug|St. John's Wort|
12080953|NCT00035399|Procedure|Acupuncture|
12080954|NCT00035360|Drug|PEG-Intron|
12080955|NCT00035347|Drug|IV azithromycin|500 mg once daily
12080956|NCT00035347|Drug|ceftriaxone|1 gram once daily for 2 to 5 days
12080957|NCT00035347|Drug|oral azithromycin|2 x 250 mg once daily
12080958|NCT00035347|Drug|IV levofloxacin|500 mg once daily
12080959|NCT00035347|Drug|oral levofloxacin|500 mg once daily
12080960|NCT00035386|Procedure|trans-right ventricular alcohol septal ablation (TRVASA)|
12080961|NCT00035334|Drug|NC-503 (Anti-amyloidotic (AA) Agent)|
12080962|NCT00035321|Drug|Olanzapine|
12080963|NCT00035321|Drug|Fluoxetine|
12080964|NCT00035308|Drug|Abetimus sodium (LJP 394)|
12080965|NCT00035295|Drug|MK0869, aprepitant|
12080966|NCT00035295|Drug|Comparator: placebo|
12080967|NCT00035282|Drug|aprepitant|
12080968|NCT00035282|Drug|Comparator: placebo (unspecified)|
12080969|NCT00035269|Drug|Antibiotic|
12080970|NCT00035256|Drug|teriparatide|
12080971|NCT00035256|Drug|raloxifene HCl|
12080972|NCT00035256|Drug|placebo|
12080973|NCT00035243|Drug|epothilone b|EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.
12080974|NCT00035230|Drug|Topiramate|
12080975|NCT00035204|Drug|galantamine|
12080976|NCT00035191|Drug|galantamine|
12080977|NCT00035178|Drug|Argatroban|
12080978|NCT00035165|Drug|epothilone b|intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off
12080979|NCT00035152|Drug|Paclitaxel and carboplatin|
12080980|NCT00035139|Drug|methylphenidate|
12080981|NCT00035126|Drug|epothilone b|
12080982|NCT00035113|Drug|epothilone b|
12080983|NCT00035100|Drug|epothilone b|
12080984|NCT00035087|Drug|epothilone b|
12080985|NCT00035074|Drug|Methotrexate|
12080986|NCT00035061|Drug|pemetrexed|
12080987|NCT00035048|Drug|aprepitant|
12080988|NCT00035048|Drug|Comparator: placebo (unspecified)|
12080989|NCT00035035|Drug|GEMZAR|
12080990|NCT00035035|Drug|ALIMTA|
12080991|NCT00035022|Drug|BCX-1777|
12080992|NCT00035009|Drug|MK0869, aprepitant|
12080993|NCT00035009|Drug|Comparator: paroxetine HCL|
12080994|NCT00034983|Drug|aprepitant|
12080995|NCT00034983|Drug|Comparator: paroxetine HCL|
12080996|NCT00034970|Behavioral|Mindfulness-based at therapy|
12080997|NCT00034957|Drug|Investigational drug|
12080998|NCT00034944|Drug|MK0869, aprepitant|
12080999|NCT00034944|Drug|Comparator: placebo|
12081000|NCT00034918|Drug|ZD6474|
12081001|NCT00034905|Drug|quetiapine fumarate vs risperidone|
12081002|NCT00034892|Drug|Olanzapine, risperidone|
12081004|NCT00034866|Drug|Protease inhibitor tipranavir|
12081005|NCT00034853|Drug|meloxicam oral suspension|
12081006|NCT00034853|Drug|naproxen oral suspension|
12081007|NCT00034840|Drug|telmisartan, valsartan|
12081008|NCT00034827|Drug|CI-1040|
12081009|NCT00034814|Drug|Talampanel|Non-enzyme-inducing TLP 35mg TID
12081010|NCT00034814|Drug|Placebo|Enzyme-inducing placebo TID
12081011|NCT00034814|Drug|Talampanel|Enzyme-inducing Talampanel 35 mg TID
12081012|NCT00034814|Drug|Talampanel|Enzyme-inducing TLP 50mg TID
12081013|NCT00034814|Drug|Placebo|Non-enzyme-inducing placebo TID
12081014|NCT00034814|Drug|Talampanel|Non-enzyme-inducing TLP 25mg TID
12081015|NCT00034801|Drug|olanzapine|
12081016|NCT00034801|Drug|ziprasidone|
12081017|NCT00034788|Drug|Becaplermin|
12081018|NCT00034775|Drug|risperidone|
12081019|NCT00034762|Drug|risperidone|
12081020|NCT00034749|Drug|Risperidone|
12081021|NCT00034736|Drug|Levofloxacin|
12081022|NCT00034710|Drug|Capsaicin Patch|
12081023|NCT00034697|Drug|temozolomide|
12081024|NCT00034684|Drug|Farnesyl Protein Transferase Inhibitor|
12081025|NCT00034671|Drug|Posaconazole oral suspension|
12081026|NCT00034658|Drug|Posaconazole|
12081027|NCT00034645|Drug|Posaconazole oral suspension|
12081028|NCT00034632|Drug|Posaconazole oral suspension|
12081029|NCT00034619|Drug|ALIMTA|
12081030|NCT00034619|Drug|Oxaliplatin|
12081031|NCT00034606|Drug|Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)|
12081032|NCT00034593|Drug|ALIMTA|
12081033|NCT00034593|Drug|gemcitabine|
12081034|NCT00034580|Drug|olanzapine|
12081035|NCT00034580|Drug|risperidone|
12081036|NCT00034554|Biological|gp75 DNA vaccine|6 patients will be enrolled in each of the 5 vaccination groups. Patients in vaccination groups 1-3 will receive a total of 5(1 mL) vaccinations. Patients assigned to vaccination group 4 will receive a total of 5 (2.0 mL) vaccinations administered as 2 1 mL injections. Patients assigned to vaccination group 5 will receive a total of 5 (4.0 mL or 8.0 mg)vaccinations administered as 4 1 mL injections per vaccination treatment Patients will receive gp75 DNA vaccinations every 3 weeks for 5 vaccinations. Injection sites will be given intramuscularly and rotated for each dose using all 4 limbs with the exception of a site that had the removal of lymph nodes. Progression to next higher dose level will be based on the 5* patient safely completing the 2nd vaccination at the lower dose level.
12081037|NCT00034541|Biological|cetuximab|400 mg/m2 i.v. over 120 minutes
12081038|NCT00034541|Drug|paclitaxel|225 mg/m2, infusion
12081039|NCT00034541|Drug|carboplatin|30-minute AUC = 6, infusion.
12081040|NCT00034528|Drug|Busulfan|0.8 mg/kg/d administered as a single intravenous infusion over 3 hours for 4 days. All infusions are anticipated to be given in the outpatient clinic.
12081041|NCT00034528|Drug|Fludarabine|30 mg/m^2/d administered as a bolus infusion over 30 minutes for 4 days. All infusions are anticipated to be given in the outpatient clinic.
12081042|NCT00034528|Drug|FK506|0.15 mg/kg taken orally daily for 12 to 14 weeks
12081043|NCT00034528|Drug|Prednisone|0.5 mg/kg taken orally four times daily on Day 7 and increase to 1 mg/kg taken orally four times daily on Day 14. Participants will continue regimen until Day 30 before a 20-25% taper per week.
12081044|NCT00034515|Drug|denufosol tetrasodium (INS37217) Inhalation Solution|
12081045|NCT00034502|Drug|ALIMTA|
12081046|NCT00034502|Drug|irinotecan|
12081047|NCT00034489|Drug|pemetrexed|
12081048|NCT00034489|Drug|gemcitabine|
12081049|NCT00034476|Drug|sPLA2 Inhibitor|
12081050|NCT00034463|Drug|ALIMTA|
12081051|NCT00034463|Drug|folic acid|
12081052|NCT00034463|Drug|multi-vitamins|
12081053|NCT00034450|Drug|L-carnitine|
12081054|NCT00034385|Drug|Valganciclovir|
12081055|NCT00034372|Drug|oregovomab|
12081056|NCT00034359|Drug|ACH-126, 443 (beta-L-Fd4C)|
12081057|NCT00034359|Drug|Lamivudine|
12081058|NCT00034359|Drug|Placebo|
12081059|NCT00017862|Drug|SCH55700|
12081060|NCT00034346|Drug|ABX-EGF|
12081061|NCT00034346|Drug|paclitaxel|
12081062|NCT00034346|Drug|carboplatin|
12081063|NCT00034333|Drug|MTC-DOX for Injection|
12081064|NCT00034307|Drug|sitaxsentan sodium|
12081065|NCT00034294|Drug|GT160-246|
12081066|NCT00034281|Drug|TAK-165|Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.
12081067|NCT00034268|Drug|LY900003|
12081068|NCT00034255|Drug|INGAP Peptide|
12081069|NCT00034203|Drug|efalizumab|
12081070|NCT00034190|Drug|S-8184 Paclitaxel Injectable Emulsion|
12081071|NCT00034177|Drug|S-8184 Paclitaxel Injectable Emulsion|
12081072|NCT00034177|Drug|Experimental Arm: TOCOSOL Paclitaxel|Doses of 80, 100 and 120mg/m2
12081073|NCT00034242|Drug|high-dose intravenous immunoglobulin (IVIG)|
12081074|NCT00034229|Drug|Felbamate|
12081075|NCT00034164|Drug|S-8184 Paclitaxel Injectable Emulsion|
12081076|NCT00034151|Drug|S-8184 Paclitaxel Injectable Emulsion|
12081077|NCT00034138|Drug|oregovomab|
12081078|NCT00034125|Drug|LY353381|
12081079|NCT00034125|Drug|tamoxifen|
12081080|NCT00034112|Procedure|osteopathic manipulative treatment|
12081081|NCT00034086|Drug|Lopinavir/Ritonavir|
12081082|NCT00034086|Drug|Lamivudine/Zidovudine|
12081083|NCT00034086|Drug|Tenofovir disoproxil fumarate|
12081084|NCT00034086|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
12081085|NCT00034086|Drug|Lamivudine|
12081086|NCT00034086|Drug|Stavudine|
12081087|NCT00034086|Drug|Zidovudine|
12081088|NCT00034086|Drug|Didanosine|
12081089|NCT00034086|Biological|Lyme Disease Vaccine Recombinant OspA|
12081090|NCT00034086|Biological|Haemophilus B Conjugate Vaccine|
12081091|NCT00034060|Drug|Etanercept|
12081092|NCT00034047|Procedure|Acupuncture|
12081093|NCT00034047|Drug|Chinese Products|
12081097|NCT00034021|Behavioral|Sex Therapy (genital focus)|
12081098|NCT00034008|Behavioral|Healing Touch|
12081099|NCT00033982|Drug|Posaconazole|
12081100|NCT00033956|Drug|M40403|
12081101|NCT00033943|Drug|deligoparin|
12081102|NCT00033917|Drug|indomethacin|an anti-inflammatory drug
12081103|NCT00033917|Drug|placebo|saline
12081104|NCT00033904|Drug|autologous human tumor-derived HSPPC-96|
12081105|NCT00033891|Drug|Infliximab|
12081106|NCT00033878|Drug|Noni Extract|
12081107|NCT00033865|Behavioral|Yoga, Relaxation Exercises, Sleep Hygiene|Sleep hygiene and relaxation exercises, with additional yoga
12081108|NCT00033852|Procedure|Massage Therapy|
12081109|NCT00033839|Drug|Civamide (Zucapsaicin)|
12081110|NCT00033813|Drug|Oxatomide (tinset)|
12081111|NCT00033215|Drug|S-3304|
12081112|NCT00033202|Drug|Gimatecan® (ST-1481)|
12081113|NCT00033189|Drug|Coenzyme Q10|
12081114|NCT00033176|Drug|Alpha Lipoic Acid|
12081115|NCT00033163|Drug|Adefovir dipivoxil|
12081116|NCT00033163|Drug|Tenofovir disoproxil fumarate|
12081117|NCT00033150|Behavioral|Fast ForWord|
12081118|NCT00033150|Behavioral|Computer Assisted Language Intervention|
12081119|NCT00033150|Behavioral|Individual Language Intervention|
12081120|NCT00033150|Behavioral|Academic enrichment|
12081121|NCT00033124|Behavioral|Behavior Therapy|
12081122|NCT00033111|Drug|Cabergoline|
12081123|NCT00033111|Drug|Placebo|sugar pill manufactured to mimic cabergoline 05mg tablet
12081124|NCT00033098|Drug|Metyrapone|
12081125|NCT00033085|Drug|Ondansetron|
12081126|NCT00033072|Drug|Selegiline|
12081127|NCT00033059|Drug|Tolcapone|
12081128|NCT00033046|Drug|Modafinil|
12081129|NCT00033033|Drug|Reserpine|
12081130|NCT00033020|Behavioral|Behavior Therapy|
12081131|NCT00033007|Behavioral|Behavior Therapy|
12081132|NCT00032994|Behavioral|Behavior Therapy|
12081133|NCT00032981|Behavioral|Behavior Therapy|
12081134|NCT00032968|Drug|Buprenorphine/naloxone|
12081135|NCT00032955|Drug|Buprenorphine/naloxone|
12081136|NCT00032942|Drug|Lofexidine|
12081137|NCT00032929|Drug|Selegiline|
12081138|NCT00032916|Drug|NS2359|
12081139|NCT00032903|Drug|Gimatecan® (ST 1481)|
12081140|NCT00032890|Drug|glucosamine|
12081141|NCT00032890|Drug|chondroitin sulfate|
12081142|NCT00032890|Drug|glucosamine and chondroitin sulfate combined|
12081143|NCT00032890|Drug|celecoxib|
12081144|NCT00032838|Drug|Yohimbine|
12081145|NCT00032825|Drug|Ketaconazole|
12081146|NCT00032825|Drug|Docetaxel|
12081147|NCT00032799|Drug|natalizumab|
12081148|NCT00032786|Drug|natalizumab|
12081149|NCT00032773|Drug|pentostatin for injection|
12081150|NCT00032812|Drug|Raclopride|
12081151|NCT00032760|Behavioral|Meditation|
12081152|NCT00032747|Drug|Vasopressin V2 Receptor Antagonist|
12081153|NCT00032734|Drug|satavaptan (SR121463B)|
12081154|NCT00032721|Procedure|Reiki; Subtle energy therapy|
12081155|NCT00032708|Biological|Dryvax|
12081156|NCT00032695|Drug|methionine|
12081157|NCT00032669|Drug|HAART|
12081158|NCT00032643|Drug|DITPA|
12081159|NCT00032630|Procedure|Coronary artery bypass - on-pump|CABG procedure performed on heart lung machine
12081160|NCT00032630|Procedure|Coronary artery bypass - off-pump|CABG procedure performed without the use of the heart lung machine
12081161|NCT00032617|Procedure|Prolonged Exposure|trauma-focused exposure therapy
12081162|NCT00032617|Procedure|Present Centered Therapy|therapy that focuses on current problems
12081163|NCT00032591|Procedure|Weekly patient self-testing of prothrombin time|
12081164|NCT00032591|Other|High quality anticoagulation management (HQACM) with conventional monthly testing|HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
12081165|NCT00032526|Drug|Corticosteroids|
12081166|NCT00032526|Behavioral|Classical conditioning to corticosteroid|
12081167|NCT00032500|Drug|Echinacea|
12081168|NCT00032487|Drug|Insulin|Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs Arm 1 Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs, add one injection of insulin Arm 2
12081169|NCT00032487|Drug|Glimepiride|Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2
12081170|NCT00032487|Drug|Rosiglitazone|Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2
12081171|NCT00032487|Drug|Metformin|Metformin 500 mg (go up to 1000 mg) Arm 1 Metformin 500 mg (go up to 2000 mg) Arm
12081172|NCT00032474|Drug|Ginkgo biloba extract|
12081173|NCT00032448|Procedure|Standardized tension-free herniorrhaphy with prosthesis|Compare the effect of two typs of operative treatment of inguinal hernia.
12081174|NCT00032435|Drug|PAL-40 Active|
12081175|NCT00032435|Drug|PAL-40 Placebo|
12081176|NCT00032422|Procedure|Acupuncture|
12081177|NCT00032409|Behavioral|Music therapy-based relaxation/stress reduction|
12081178|NCT00032396|Drug|Retisert Implant|
12081179|NCT00032383|Behavioral|Tai Chi|
12081180|NCT00032370|Procedure|Vascular surgery with best medical treatment|Patients undergo scheduled vascular surgery
12081181|NCT00032370|Procedure|Coronary artery bypass grafting (CABG)|Coronary artery bypass grafting prior to vascular surgery
12081182|NCT00032370|Procedure|Percutaneous transluminal coronary angioplasty (PTCA)|Cardiac revascularization via PTCA prior to vascular surgery
12081183|NCT00032357|Procedure|Ferritin reduction to 25 ng/ml by phlebotomy|
12081184|NCT00032344|Procedure|Colonoscopy|Phase I - Cross-sectional; Phase II - 5 year follow-up; Phase III - 10 year follow-up
12081185|NCT00032331|Procedure|PET Imaging|
12081186|NCT00032331|Procedure|CT scan|
12081187|NCT00032305|Drug|Visilizumab|
12081188|NCT00032292|Drug|Visilizumab|
12081189|NCT00032279|Drug|Visilizumab|
12081190|NCT00032240|Device|Shoe Insert|
12081191|NCT00032227|Procedure|Early Carpal Tunnel Release for Mild or Moderate CTS|Either open or endoscopic surgery
12081192|NCT00032227|Other|MR Nerve Imaging for CTS|New diagnostic test for CTS to directly image the median nerve
12081193|NCT00031551|Drug|Etanercept|
12081194|NCT00031551|Drug|Placebo|
12081195|NCT00031512|Drug|Placebo|Placebo.
12081196|NCT00031512|Drug|Pleconaril (VP63843)|5 mg/kg /dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral liquid formulation and 8.5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral suspension formulation.
12081197|NCT00031499|Drug|Azithromycin|Single 2 gram oral dose (4 tablets) at Day 1.
12081198|NCT00031499|Drug|Benzathine Penicillin|Supplied in pre-filled syringes containing 1.2 million units of benzathine penicillin; 2.4 million units administered intramuscularly at Day 1, in one or both buttocks.
12081199|NCT00031499|Drug|Doxycycline|Baseline visit, 28 capsules dispensed, for a dose of 100 mg twice a day (BID).
12081200|NCT00031486|Drug|Valacyclovir|Valacyclovir is a L-valyl ester of acyclovir. Valacyclovir is provided in 500 mg tablets, 4 tablets (500 mg tablets) 3 times a day (every 8 hours) for 90 days.
12081201|NCT00031486|Drug|Placebo|Placebo (identical to active drug in appearance) 500 mg tablets, 4 tablets 3 times daily for 90 days.
12081202|NCT00031473|Drug|Virazole (Ribavirin) Inhalation Solution|
12081203|NCT00031460|Drug|Acyclovir|Oral banana flavored acyclovir suspension: 300 mg/m^2/dose three times a day (TID), to be given at least 6 to 8 hours apart for 6 months. Dosage adjustments will be made monthly to compensate for increases in body surface area.
12081204|NCT00031460|Drug|Placebo|Oral banana flavored placebo suspension: to be given at least 6 to 8 hours apart for 6 months. Dosage adjustments will be made monthly to compensate for increases in body surface area.
12081205|NCT00031447|Drug|Acyclovir|Oral suspension 300 mg/m^2/dose, 3 times per day (TID), for 6 months.
12081206|NCT00031447|Drug|Placebo|Placebo identical to oral acyclovir suspension in appearance and taste.
12081207|NCT00031434|Drug|Valganciclovir|Valganciclovir is a mono-valyl ester pro-drug of ganciclovir, which is rapidly converted to ganciclovir on absorption. Valganciclovir oral syrup formulation for administration will be provided as a 15g powder blend containing 3g valganciclovir base, for constitution in 120 mL amber glass bottles. The beginning oral valganciclovir dose under investigation is 14 mg/kg. The dose of oral valganciclovir syrup will be adjusted for the baby's weight and renal function. Weights upon which dosage will be adjustments will be made will be obtained on study days 1, 7, 14, 21, 28, and 35.
12081208|NCT00031434|Drug|Ganciclovir|Ganciclovir for intravenous infusion will be provided as sterile, lyophilized powder in sealed vials containing 500 mg ganciclovir for re-constitution. The dose of intravenous ganciclovir is 6 mg/kg. Intravenous ganciclovir will be adjusted for the baby's weight and renal function. Weights upon which dosage adjustments will be made will be obtained on study days 1, 7, 14, 21, 28, and 35. Each dose of intravenous ganciclovir should be given over 1 hour using an intravenous pump.
12081209|NCT00031395|Drug|clonidine|Clonidine is FDA-approved for the treatment of hypertension in adults.
12081210|NCT00031395|Drug|methylphenidate|MPH is FDA-approved for the treatment of ADHD symptoms in children.
12081211|NCT00031395|Other|placebo|an inactive substance
12081212|NCT00031343|Drug|highly active antiretroviral therapy (HAART)|
12081213|NCT00031317|Drug|Paroxetine|
12081214|NCT00031317|Drug|Clozapine|
12081215|NCT00031291|Drug|Anthrax Immune Globulin|
12081216|NCT00031278|Drug|CPG 7909|Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
12081217|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
12081218|NCT00031278|Drug|CPG 7909|Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
12081219|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
12081220|NCT00031278|Drug|CPG 7909|Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
12081221|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
12081222|NCT00031278|Drug|CPG 7909|Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
12081223|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
12081224|NCT00031265|Procedure|Family Intervention Telephone Tracking|
12081225|NCT00031187|Drug|SGN-15 (cBR96-doxorubicin immunoconjugate)|
12081226|NCT00031187|Drug|Taxotere (docetaxel)|
12081227|NCT00031161|Drug|Nitisinone (NTBC)|
12081228|NCT00031161|Drug|Dichloroacetate|
12081229|NCT00031161|Behavioral|Low-tyrosin diet|
12081230|NCT00031148|Drug|Recombinant Human Keratinocyte Growth Factor (rHuKGF)|
12081231|NCT00031135|Drug|Choline Chloride|
12081232|NCT00031122|Other|No Intervention|There is no intervention in this study
12081233|NCT00031109|Biological|gp160 MN/LAI-2|
12081234|NCT00031109|Biological|Aluminum hydroxide|
12081235|NCT00031096|Drug|Azelaic Acid Gel 15% (Finacea, BAY39-6251)|Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
12081236|NCT00031096|Drug|Vehicle gel (SH H 655 PBA)|Vehicle gel (SH H 655 PBA) applied topically two times per day.
12081237|NCT00031083|Genetic|Interferon-beta|
12081238|NCT00031070|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
12081239|NCT00031070|Drug|Cyclosporine|
12081240|NCT00031070|Biological|Hepatitis A Vaccine (Inactivated)|
12081241|NCT00031070|Drug|Efavirenz|
12081242|NCT00031070|Biological|Pneumococcal Conjugate Vaccine, Heptavalent|
12081243|NCT00031070|Biological|Rabies Vaccine|
12081244|NCT00031057|Drug|Thiamine hydrochloride|
12081245|NCT00031057|Drug|Riboflavin|
12081246|NCT00031044|Drug|Enfuvirtide|
12081247|NCT00031044|Drug|Amdoxovir|
12081248|NCT00031031|Drug|Kanglaite Injection (KLT)|
12081249|NCT00031018|Drug|Aricept|
12081250|NCT00031018|Drug|IFN-alpha2A|
12081251|NCT00031005|Procedure|modified stem cell transplant|
12081252|NCT00030992|Drug|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
12081253|NCT00030992|Drug|Ranitidine|50 mg 30-60 minutes prior to Ixabepilone (BMS-247550)
12081254|NCT00030992|Drug|Diphenhydramine|50 mg intravenously 30-60 minutes prior to Ixabepilone (BMS-247550)
12081255|NCT00030979|Drug|Donepezil|
12081256|NCT00030966|Drug|Natalizumab|Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
12081257|NCT00030966|Drug|Placebo|Placebo monthly infusion for up to 116 weeks.
12081258|NCT00030238|Drug|Calcium supplement|Calcium Carbonate capsules prepared by NIH PDS
12081259|NCT00030238|Drug|Placebo|Placebo capsules prepared by the NIH PDS to be identical to Calcium Carbonate capsules
12081260|NCT00030225|Biological|ELAD|
12081261|NCT00030225|Other|Standard of care (Control)|
12081262|NCT00030186|Drug|CEP-701 60mg|60mg orally 2 times a day for 28 days
12081263|NCT00030186|Drug|Cep-701 80mg|80mg 2 times a day, dependent upon response to cycle 1
12081264|NCT00030186|Drug|Cep-701 40mg|40mg 2 times a day, dependent upon response to cycle 1
12081265|NCT00030173|Drug|Epothilone D (KOS-862)|
12081266|NCT00030160|Behavioral|Strength Training|
12081267|NCT00030147|Drug|Raloxifene|60 mg a day orally administered
12081268|NCT00030147|Drug|Rimostil|1000 mg twice a day administered orally
12081269|NCT00030147|Drug|Transdermal Estradiol|100 microgram per day transdermal estradiol
12081270|NCT00030147|Drug|Placebo skin patch and placebo tablets|matched placebo skin patch to transdermal estradiol and matched tablets to either Raloxifene or Rimostil
12081271|NCT00030121|Drug|recombinant human atrial natriuretic polypeptide|
12081272|NCT00030069|Drug|Calcitriol|
12081273|NCT00030069|Drug|Dexamethasone|
12081274|NCT00030056|Drug|GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim)|
12081275|NCT00030043|Device|Penetrating auditory brainstem implant|
12081276|NCT00030030|Drug|Silymarin (milk thistle)|
12081277|NCT00030004|Procedure|spinal manipulation|
12081278|NCT00030004|Drug|midazolam|
12081279|NCT00029991|Drug|Gingko Biloba (Herb)|
12081280|NCT00029926|Drug|2-deoxy-2 [F-18] fluoro-2-d-glucose|
12081281|NCT00029913|Other|Observation|Observation of participants who received HIV preventive vaccine and became infected.
12081282|NCT00029900|Drug|ADI PEG|
12081283|NCT00029874|Drug|Minocycline|
12081284|NCT00029861|Drug|Rimonabant (SR141716)|
12081285|NCT00029848|Drug|Rimonabant (SR141716)|
12081286|NCT00029835|Drug|Rimonabant (SR141716)|
12081287|NCT00029822|Drug|Alfuzosin (SL770499)|
12081288|NCT00029809|Behavioral|Chinese exercise modalities|
12081289|NCT00029796|Drug|soy isoflavones|
12081290|NCT00029783|Procedure|Distant Healing|
12081291|NCT00029770|Procedure|Chiropractic spinal manipulation|
12081292|NCT00029770|Drug|Acetaminophen|
12081293|NCT00029770|Behavioral|Self-care|
12081294|NCT00029770|Drug|Non-Steroidal anti-inflammatory drugs (NSAIDS)|
12081295|NCT00029770|Drug|Tylenol with codeine|
12081296|NCT00029757|Drug|Estrogen|
12081297|NCT00029731|Drug|Arginine hydrochloride|
12081298|NCT00029692|Drug|Ginseng|
12081299|NCT00029692|Drug|Ginkgo|
12081300|NCT00029679|Drug|Gingko biloba|
12081301|NCT00029679|Drug|Borage oil|
12081302|NCT00029666|Device|Neopulse Magnetic Stimulator|
12081303|NCT00029627|Drug|Yohimbine|
12081304|NCT00029614|Drug|Atomoxetine|
12081305|NCT00029575|Device|Surgi-Vision Guidewire Coil|
12081306|NCT00029536|Biological|Progesterone Lozenges|200mg Progesterone Lozenges
12081307|NCT00029536|Other|Matched Placebo Lozenges|Matched Placebo Lozenges
12081308|NCT00029523|Drug|Intrathecal (injected into the spinal fluid) DepoCyt|
12081309|NCT00029523|Drug|Intrathecal methotrexate|
12081310|NCT00029523|Drug|Intrathecal cytarabine (also known as ara-C)|
12081311|NCT00029510|Drug|Magnesium|
12081312|NCT00029497|Procedure|Acupuncture|
12081313|NCT00029497|Drug|Amitriptyline|
12081314|NCT00029484|Behavioral|Tai chi chih|
12081315|NCT00029458|Drug|Clozapine|
12081316|NCT00029393|Procedure|Hematopoietic Stem Cell Transplantation|
12081317|NCT00029393|Drug|Immunosuppression|
12081318|NCT00029380|Drug|Sangstat|
12081319|NCT00029380|Drug|Cyclophosphamide|
12081320|NCT00029380|Drug|Busulfan|
12081321|NCT00029380|Drug|Mycophenolate Mofetil|
12081322|NCT00029380|Drug|Cyclosporine|
12081323|NCT00029380|Procedure|Cord Blood Transplantation|
12081324|NCT00029341|Behavioral|Treatment Interruption|
12081325|NCT00029328|Drug|etanercept|
12081326|NCT00029315|Drug|Recombinant Tissue Plasminogen Activator (rt-PA)|
12081327|NCT00029289|Drug|Lutein (10 or 30 mg/day) capsules|
12081328|NCT00029276|Procedure|Prefrontal transcranial magnetic brain stimulation|
12081329|NCT00029263|Drug|herbals|
12081330|NCT00029250|Drug|Garlic powder standardized to allicin|
12081331|NCT00029237|Behavioral|Cognitive-behavioral relaxation (Positively Living)|
12081332|NCT00029237|Behavioral|Spiritual growth group|
12081333|NCT00029237|Behavioral|Focused Tai Chi|
12081334|NCT00029224|Drug|zoledronic acid|
12081335|NCT00029211|Drug|Echinacea|
12081336|NCT00029198|Procedure|massage|15 massage given tid
12081337|NCT00029198|Procedure|Sham massage|non-massage touch
12081338|NCT00029185|Drug|Dehydrex|
12081339|NCT00029172|Other|case management|
12081340|NCT00029159|Drug|estrogen|Participants were started on ethinyl estradiol at a daily dose of 50ng/kg at the beginning of the 3rd year of the study. The estrogen was continued until study end.
12081341|NCT00029159|Drug|androgen|Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years
12081342|NCT00029159|Other|placebo|an inactive substance
12081343|NCT00029146|Procedure|extracranial-intracranial bypass surgery|Surgical anastomosis of a superficial temporal artery branch to a middle cerebral artery branch through a small craniectomy plus best current practice medical therapy
12081344|NCT00029146|Drug|best medical therapy|best current practice medical therapy
12081345|NCT00029133|Procedure|mild intraoperative hypothermia (33 degrees Celsius)|
12081346|NCT00028431|Biological|MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine|
12081347|NCT00028418|Drug|Clofarabine|
12081348|NCT00028405|Drug|LS 11(Taporfin Sodium)|
12081349|NCT00028405|Device|Lumaflex Light Delivery Catheter|
12081350|NCT00029107|Drug|Rituximab|anti-CD20 monoclonal antibody
12081351|NCT00029042|Drug|Infliximab|
12081352|NCT00028379|Procedure|Transcranial magnetic stimulation (TMS)|
12081353|NCT00028366|Drug|Fosamprenavir|
12081354|NCT00028366|Drug|Lopinavir/Ritonavir|
12081355|NCT00028366|Drug|Ritonavir|
12081356|NCT00028366|Drug|Tenofovir disoproxil fumarate|
12081357|NCT00028353|Drug|GTX-006 (Acapodene)|
12081358|NCT00028327|Drug|Lamivudine/Zidovudine|
12081359|NCT00028327|Drug|Nelfinavir mesylate|
12081360|NCT00028327|Drug|Efavirenz|
12081361|NCT00028327|Drug|Lamivudine|
12081362|NCT00028327|Drug|Zidovudine|
12081363|NCT00028314|Drug|Abacavir sulfate|
12081364|NCT00028314|Drug|Atazanavir/Ritonavir|
12081365|NCT00028314|Drug|Lopinavir/Ritonavir|
12081366|NCT00028314|Drug|Nevirapine|
12081367|NCT00028301|Drug|Atazanavir|
12081368|NCT00028301|Drug|Lopinavir/Ritonavir|
12081369|NCT00028288|Drug|Daclizumab|
12081370|NCT00028275|Drug|Gamma Interferon 1b|
12081371|NCT00028262|Drug|Cystagon|
12081372|NCT00028236|Drug|Gene-Transduced Autologous CD34+ Stem Cells|
12081373|NCT00028171|Drug|Tacrolimus|
12081374|NCT00028158|Drug|G207, an oncolytic virus|
12081375|NCT00028145|Behavioral|Adherence assessment|Adherence will be assessed using questionnaires at all study visits.
12081376|NCT00028132|Drug|Tenofovir|
12081377|NCT00028106|Drug|[131]I-MIBG|
12081378|NCT00028106|Drug|6-[18F]Fluorodopamine|
12081379|NCT00028106|Drug|[123]I-MIBG|
12081380|NCT00028093|Drug|Peginterferon alfa-2a with Ribavirin|Eligible patients were given peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients <75 kg and 1200 mg daily for patients >=75 kg) for 48 weeks
12081381|NCT00028093|Drug|Peginterferon alfa-2a|Eligible patients were given peginterferon-alpha-2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
12081382|NCT00028067|Drug|Atazanavir|
12081383|NCT00028067|Drug|Nelfinavir mesylate|
12081384|NCT00027469|Procedure|MRI|
12081385|NCT00027456|Drug|Leptin A-100|
12081386|NCT00027443|Drug|Muromonab-CD3|
12081387|NCT00027443|Drug|Cyclosporine|
12081388|NCT00027430|Drug|TheraDerm|
12081389|NCT00027417|Drug|Liothyronine sodium/triiodothyronine|
12081390|NCT00027417|Procedure|Cardiopulmonary bypass and cardiac surgery|
12081391|NCT00027404|Drug|Fluoxetine|
12081392|NCT00027391|Drug|Albuterol|
12081393|NCT00027391|Drug|Oxandrolone|
12081394|NCT00027378|Drug|fluoxetine (Prozac)|fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up
12081395|NCT00027378|Drug|Placebo plus Treatment As Usual|placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up
12081396|NCT00027365|Biological|Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A|
12081397|NCT00027365|Biological|NefTat|
12081398|NCT00027365|Drug|AS02A Adjuvant|
12081399|NCT00027365|Biological|gp120W61D|
12081400|NCT00027339|Drug|lopinavir/ritonavir|
12081401|NCT00027339|Drug|indinavir sulfate|
12081402|NCT00027339|Drug|tenofovir disoproxil fumarate|
12081403|NCT00027339|Drug|ritonavir|
12081404|NCT00027339|Drug|fosamprenavir|
12081405|NCT00027300|Drug|Natalizumab|Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
12081406|NCT00027300|Drug|Placebo|Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
12081407|NCT00027287|Drug|Vitamin E|
12081408|NCT00027261|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081409|NCT00027248|Drug|MBI 226|
12081410|NCT00027209|Drug|prempro|
12081411|NCT00027170|Device|Siemens MRI scanner|Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.
12081412|NCT00027144|Biological|Heat Shock Protein 70 HSP70|
12081413|NCT00027131|Biological|Heat Shock Protein 70-peptide complexes (HSP70)|
12081414|NCT00027079|Drug|ondansetron (Zofran)|
12081415|NCT00027079|Drug|naltrexone (ReVia)|
12081416|NCT00027079|Behavioral|Cognitive Behavioral Therapy|
12081417|NCT00027066|Drug|Active Aspirin|325mg tablet daily
12081418|NCT00027066|Drug|Active Warfarin|2mg scored tablet daily
12081419|NCT00027066|Drug|Aspirin placebo|325mg aspirin placebo pill
12081420|NCT00027066|Drug|Warfarin placebo|2mg scored placebo tablet
12081421|NCT00027053|Drug|Trazodone|50 to 150 mg qhs
12081422|NCT00027053|Drug|Placebo|
12081423|NCT00027040|Drug|Selegiline hydrochloride|
12081424|NCT00027027|Drug|rhuMAb 2C4|
12081425|NCT00027014|Drug|St. John's Wort|
12081426|NCT00027014|Drug|oxycodone|
12081427|NCT00027014|Drug|fentanyl|
12081428|NCT00027001|Behavioral|Aerobic and Resistance Exercises|
12081429|NCT00027001|Behavioral|Qigong|
12081430|NCT00026988|Drug|Creatine|
12081431|NCT00026975|Procedure|Hyperbaric Oxygen|
12081432|NCT00026962|Procedure|measuring estradiol and progesterone levels in saliva|
12081433|NCT00026936|Procedure|Radiotherapy|
12081434|NCT00026923|Procedure|Laparoscopic surgery|
12081435|NCT00026897|Procedure|Gamma-camera imaging|
12081436|NCT00026897|Procedure|Low-risk biopsy|
12081437|NCT00026871|Procedure|Radiotherapy|
12081438|NCT00026858|Behavioral|collaboration|
12081439|NCT00026819|Drug|Rofecoxib|
12081440|NCT00026637|Drug|sertraline|Sertraline: 25-200mg PO (orally); Subjects begin at 25mg for week 1 and increase to 50mg at the beginning of week 2. Sertraline is increased in 50mg increments when subjects score in the depressed range on the CES-D, a questionnaire that is administered every 2 weeks over the 16 week intervention period. Subjects may reduce dosage if toxicity occurs.
12081441|NCT00026637|Behavioral|cognitive behavior therapy|CBT (Cognitive Behavior Therapy) - CBT is a psychotherapy based on modifying cognitions, assumptions, beliefs and behaviors, with the aim of influencing disturbed emotions. Subjects will meet with a trained CBT therapist for 1 hour each week over the 16 week intervention period and will be given assignments to work on each week.
12081442|NCT00026624|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081443|NCT00026624|Drug|Keyhole-Limpet Hemocyanin|
12081444|NCT00026611|Biological|Dryvax vaccine|
12081445|NCT00026585|Drug|Tamoxifen|
12081446|NCT00026559|Device|Shock Device|Shock Device
12081447|NCT00026559|Device|Auditory Startle Device|Auditory Startle Device
12081448|NCT00026065|Behavioral|Biofeedback|
12081449|NCT00026052|Drug|riluzole|
12081450|NCT00026039|Drug|estrogen|
12081451|NCT00026013|Drug|hypericum perforatum|
12081452|NCT00025987|Device|Head and Neck Cooling System|
12081453|NCT00025987|Device|Thermometer Pill|
12081454|NCT00025909|Procedure|Leukapheresis|
12081455|NCT00025896|Drug|recombinant human acid alpha-glucosidase (rhGAA)|
12081456|NCT00027222|Procedure|retinal ablation|
12081457|NCT00025818|Drug|Ophthalmic Emulsion|
12081458|NCT00025883|Drug|Metreleptin|Drug treatment
12081459|NCT00025805|Drug|G-CSF|
12081460|NCT00025792|Drug|Pramipexole|
12081461|NCT00025779|Drug|methylphenidate|
12081462|NCT00025779|Drug|guanfacine|
12081463|NCT00025766|Device|PCI with stenting|PCI with stenting of the occluded culprit infarct-related artery
12081464|NCT00025766|Behavioral|Optimal Medical Therapy|Participants will receive optimal medical therapy.
12081465|NCT00025753|Drug|rosiglitazone (Avandia)|
12081466|NCT00025753|Behavioral|Aerobic and weight lifting exercise training|
12081467|NCT00025740|Drug|clonazepam and paroxetine|
12081468|NCT00025727|Drug|Lopinavir/Ritonavir|
12081469|NCT00025727|Drug|Ritonavir|
12081470|NCT00025727|Drug|GW433908|
12081471|NCT00024986|Drug|Tenofovir DF|
12081472|NCT00024934|Drug|B-Lymphocyte Stimulator (BLyS)|
12081473|NCT00024687|Drug|SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin|
12081474|NCT00024674|Drug|SS1(dsFv)-PE38|
12081475|NCT00024661|Drug|LErafAON|
12081476|NCT00024648|Drug|LErafAON|
12081477|NCT00024570|Drug|IL13-PE38QQR|
12081478|NCT00024570|Procedure|targeted fusion protein therapy|
12081479|NCT00024570|Procedure|surgery|
12081480|NCT00024557|Drug|IL13-PE38QQR|
12081481|NCT00024557|Procedure|targeted fusion protein therapy|
12081482|NCT00024557|Procedure|surgery|
12081483|NCT00024544|Drug|anti-IL-4 monoclonal antibody (pascolizumab)|
12081484|NCT00024531|Drug|Atorvastatin calcium|
12081485|NCT00024518|Drug|30,000 units hrINF-alpha|
12081486|NCT00024518|Drug|5,000 hrINF-alpha|
12081487|NCT00024518|Other|Placebo|placebo was prepared as saline alone with 6mg human serum albumin (HSA).
12081488|NCT00024492|Drug|Liposome Encapsulated Mitoxantrone (LEM)|
12081489|NCT00023595|Procedure|CABG surgery plus MED|CABG plus standard medication management for Coronary Artery Disease
12081490|NCT00023595|Drug|Active Medication Alone|Standard medication for coronary artery disease and heart failure management.
12081491|NCT00023595|Procedure|CABG plus MED and SVR|H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
12081492|NCT00023504|Biological|Pneumovax|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
12081493|NCT00023504|Biological|Rabavert|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
12081494|NCT00023504|Biological|Prevnar|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
12081495|NCT00023504|Biological|Tetanus diphtheria toxoid|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
12081496|NCT00023465|Procedure|FDG-PET|
12081497|NCT00023465|Procedure|spirometry|
12081498|NCT00023465|Procedure|bronchoscopy with BAL|
12081499|NCT00023452|Drug|RPT + INH once weekly for 3 months given by DOT|"Rifapentine (RPT) 900 mg once-weekly x 12 doses (3 months) for persons > 50.0 kg. For persons < 50.0 kg, the following doses will be given (Weight/Dose): 10.0-14.0 kg / 300 mg; 14.1-25.0 kg / 450 mg; 25.1-32.0 kg / 600 mg; 32.1-50.0 kg / 750 mg.
~PLUS
~Isoniazid (INH) 15 mg/kg (rounded up to nearest 50 or 100 mg; 900 mg max) once weekly x 12 doses if > 12 years old. INH 25 mg/kg (round up to nearest 50 or 100 mg; 900 mg max) if 2-11 years old.
~Therapy will be given by Directly Observed Therapy (DOT)."
12081500|NCT00023452|Drug|Isoniazid (INH) daily for 9 months|Isoniazid (INH) 5 mg/kg (rounded up to nearest 50 or 100 mg; 300 mg max) daily x 270 doses (9 months) For children age 2 - 11, INH 10-15 mg/kg (round up to nearest 50 or 100 mg; 300 mg max) will be given.
12081501|NCT00023439|Other|Nucleic Acid Amplification Methods for diagnosis|no intervention
12081502|NCT00023426|Drug|rifapentine|
12081503|NCT00023413|Drug|Rifabutin|
12081504|NCT00023413|Drug|Efavirenz|
12081505|NCT00023400|Drug|Nelfinavir|
12081506|NCT00023400|Drug|Rifabutin|
12081507|NCT00023387|Drug|Rifapentine|
12081508|NCT00023387|Drug|25-desacetyl Rifapentine|
12081510|NCT00023374|Drug|Rifampin|6mos REZ intermittent
12081511|NCT00023374|Drug|Pyrazinamide|6mos REZ intermittent
12081512|NCT00023374|Drug|Ethambutol|6mos REZ intermittent
12081513|NCT00023374|Drug|REZ|Rif+PZA+EMB given 2 or 3 times weekly for 6 months
12081514|NCT00023361|Drug|Rifabutin|
12081515|NCT00023348|Drug|Isoniazid|
12081516|NCT00023348|Drug|Rifabutin|
12081517|NCT00023335|Drug|Rifapentine|
12081518|NCT00023335|Drug|Isoniazid|
12081519|NCT00023543|Behavioral|Diet, fat-restricted|Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.
12081520|NCT00023543|Behavioral|Exercise|Rigorous, stepped care approach to reach 150 min/week of physical activity.
12081521|NCT00023530|Drug|fluconazole|
12081522|NCT00023530|Drug|voriconazole|
12081523|NCT00023530|Procedure|bone marrow transplant|
12081524|NCT00023530|Drug|thalidomide|
12081525|NCT00023530|Drug|dexamethasone|
12081526|NCT00023322|Drug|Peginterferon Alpha-2a|Treatment
12081527|NCT00023309|Drug|Lamivudine and adefovir|Lamivudine (100 mg/day) and adefovir (10 mg/day)
12081528|NCT00023309|Drug|Adefovir alone|Adefovir (10 mg/day)
12081529|NCT00023296|Drug|Nitric Oxide|
12081530|NCT00023296|Device|INO Pulse - NO Delivery System|
12081531|NCT00023283|Drug|Buprenorphine|"Experimental Standard Medical Management with once-weekly medication dispensing
~Experimental Standard Medical Management with thrice-weekly medication dispensing
~Experimental Enhanced Medical Management with thrice-weekly medication dispensing"
12081532|NCT00023244|Drug|Basiliximab|Administered as a bolus intravenous injection. The first dose is given pre-operatively, the second dose is given on post-transplant day four. Dosage is determined by individual weight.
12081533|NCT00023244|Drug|Cyclosporine|Participants receiving cyclosporine microemulsion formula (in lieu of tacrolimus) will have the dose adjusted to maintain a whole blood trough Abbott TDx assay monoclonal level of 175-400 ng/mL (or an equivalent high pressure liquid chromatography (HPLC) level) for the first 2 weeks after transplant. The dose will subsequently be tapered to maintain a trough level of 175-300 ng/mL from week 3 to month 3, and 50-250 ng/mL from month 3 through the end of the study at month 36 (year 3).
12081534|NCT00023244|Drug|Tacrolimus|Participants receiving tacrolimus (in lieu of Cyclosporine) will have the dose adjusted to maintain a whole blood trough level between 10 and 15 ng/mL for the first 4weeks after transplant. Trough levels will be maintained between 5 and 10 ng/mL thereafter throughout the duration of the study.
12081535|NCT00023244|Drug|Sirolimus|Participants take daily (orally, either as tablets or as liquid) starting on postoperative day 1 at a dose of 6 mg/m2 and will be adjusted to maintain a trough level of 10-20 ng/mL throughout the study.
12081536|NCT00023244|Drug|Methylprednisolone|Administered at 10 mg/kg intravenously perioperatively and on postoperative day 1.
12081537|NCT00023244|Drug|Prednisone|Administered orally beginning on Post-Op Day 2 and maintained for all participants until day 180. Randomization will determine whether patients will maintain this treatment following day 180.
12081538|NCT00023244|Drug|Bactrim|All subjects will receive TMP SMX (Bactrim), pneumocystis jiroveci (carinii) prophylaxis, beginning on postoperative day 1 and continuing for 6 months following transplant. Dosage: 10 mg/kg taken orally three times weekly (maximum dose 160 mg).
12081539|NCT00023231|Drug|Daclizumab|1 mg/kg/dose at study entry and Weeks 2, 4, 6, and 8
12081540|NCT00023231|Drug|Methylprednisolone/prednisone|Dosage is dependent on weight and varies throughout study. Refer to protocol for more information.
12081541|NCT00023231|Drug|Mycophenolate mofetil|Solution or oral tablet taken daily. Dosage depends on body surface area.
12081542|NCT00023231|Drug|Sirolimus|Oral tablet taken once prior to transplant. Dosage dependent on body surface area.
12081543|NCT00023231|Drug|Bactrim|Oral tablet taken three times per week. Dosage is dependent on weight.
12081544|NCT00023231|Drug|Ganciclovir|Oral tablet taken daily. Dosage is dependent on weight.
12081545|NCT00023231|Drug|Lipitor|Oral tablet taken daily
12081546|NCT00023218|Drug|Lopinavir/Ritonavir|
12081547|NCT00023218|Drug|Efavirenz|
12081548|NCT00023205|Behavioral|11th grade reading level arthritis materials|
12081549|NCT00023205|Behavioral|Interactive in-person arthritis education|
12081550|NCT00022763|Drug|Enfuvirtide|
12081551|NCT00021762|Biological|HIV-1 Immunogen|
12081552|NCT00021762|Procedure|Structured Treatment Interruption|
12081553|NCT00021671|Drug|Erythromycin|
12081554|NCT00021671|Drug|Nevirapine|
12081555|NCT00021671|Drug|Ampicillin sodium|
12081556|NCT00021671|Drug|Metronidazole|
12081557|NCT00021554|Drug|Enfuvirtide|
12081558|NCT00021489|Drug|Abacavir sulfate|
12081559|NCT00021489|Drug|Mycophenolate mofetil|
12081560|NCT00021463|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
12081561|NCT00021463|Drug|Abacavir sulfate|
12081562|NCT00021463|Drug|Efavirenz|
12081563|NCT00021463|Drug|Nevirapine|
12081564|NCT00017992|Drug|Lopinavir/Ritonavir|
12081565|NCT00017992|Drug|Emtricitabine|
12081566|NCT00017992|Drug|Stavudine|
12081567|NCT00017784|Drug|Valganciclovir|
12081568|NCT00017758|Drug|Pravastatin sodium|
12081569|NCT00017758|Drug|Simvastatin|
12081570|NCT00017758|Drug|Atorvastatin calcium|
12081571|NCT00017758|Drug|Nelfinavir mesylate|
12081572|NCT00017758|Drug|Efavirenz|
12081573|NCT00017719|Drug|Lamivudine|
12081574|NCT00017719|Drug|Lamivudine/Zidovudine|
12081575|NCT00017719|Drug|Nelfinavir mesylate|
12081576|NCT00017719|Drug|Nevirapine|
12081577|NCT00017719|Drug|Zidovudine|
12081578|NCT00017693|Biological|Recombinant human soluble IL-4 receptor|Subjects were randomized to twelve once weekly nebulizations of 0.75, 1.5, or 3.0 mg dose of recombinant human soluble IL-4 receptor (rsIL-4R)
12081579|NCT00017693|Biological|Placebo for Recombinant human soluble IL-4 receptor|Subjects were randomized to twelve once weekly nebulizations of placebo for recombinant human soluble IL-4 receptor (rsIL-4R). Identically prepared (to the recombinant human soluble IL-4 receptor) in the same volume
12081580|NCT00016718|Drug|Didanosine (ddI)|Antiretroviral Didanosine (ddI) : 240 mg/m^2 up to a maximum of 400 mg once daily
12081581|NCT00016718|Drug|Efavirenz (EFV)|Antiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution
12081582|NCT00016718|Drug|Emtricitabine (FTC)|Antiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily
12081583|NCT00016692|Drug|Z-100|
12081584|NCT00016601|Drug|Indinavir sulfate|
12081585|NCT00016601|Drug|Ritonavir|
12081586|NCT00016601|Drug|Nelfinavir mesylate|
12081587|NCT00016601|Drug|Efavirenz|
12081588|NCT00016601|Drug|Nevirapine|
12081589|NCT00016601|Drug|Medroxyprogesterone acetate|
12081590|NCT00016588|Drug|Tenofovir disoproxil fumarate|
12081591|NCT00016536|Drug|Naphthalene 2-sulfonate polymer|
12081592|NCT00016536|Drug|Carbopol polymer|
12081593|NCT00015704|Drug|Aldesleukin|
12081594|NCT00015691|Drug|Metformin hydrochloride|
12081595|NCT00015691|Drug|Rosiglitazone maleate|
12081596|NCT00015652|Drug|Ribavirin|
12081597|NCT00015652|Drug|Aldesleukin|
12081598|NCT00015652|Drug|Peginterferon alfa-2b|
12081599|NCT00014937|Drug|lopinavir/ritonavir|
12081600|NCT00014937|Drug|lamivudine/zidovudine|
12081601|NCT00014937|Drug|efavirenz|
12081602|NCT00014937|Drug|lamivudine|
12081603|NCT00014937|Drug|stavudine|
12081604|NCT00014937|Drug|zidovudine|
12081605|NCT00014937|Drug|didanosine|
12081606|NCT00014911|Procedure|Islet Transplantation|Participants will receive portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. Up to three transplants are possible depending on individual results.
12081607|NCT00014911|Drug|Sirolimus|Administered at a dose of 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing will be adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
12081608|NCT00014911|Drug|Tacrolimus|Administered at a dose of 1 mg by mouth once pre-transplantation followed by 1 mg twice daily post transplantation. Levels will be adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
12081609|NCT00014911|Drug|Daclizumab|Administered at a dose of 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation, totaling 5 doses(over 8 weeks). Further daclizumab dosing may be necessary based on individual results and islet transplantation needs.
12081610|NCT00014911|Drug|Sulfamethoxazole|An antibacterial used to prevent opportunistic infections
12081611|NCT00014911|Drug|Ganciclovir|An antiviral used to kill viruses and stop viral replication
12081612|NCT00014911|Drug|Trimethoprim|An antibacterial used to prevent opportunistic infections
12081613|NCT00014911|Drug|Pentamidine|An antiprotozoal used to prevent disease
12081614|NCT00014014|Drug|Lamivudine/Zidovudine|
12081615|NCT00013897|Drug|Atazanavir|
12081616|NCT00013897|Drug|Lamivudine/Zidovudine|
12081617|NCT00013897|Drug|Efavirenz|
12081618|NCT00013871|Biological|Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed|
12081619|NCT00013871|Biological|Measles-Mumps-Rubella Vaccine (Live)|
12081620|NCT00013871|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
12081621|NCT00013871|Biological|Pneumococcal Conjugate Vaccine, Heptavalent|
12081622|NCT00013871|Biological|Hepatitis B Vaccine (Recombinant)|
12081623|NCT00013663|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081624|NCT00013663|Drug|Aldesleukin|
12081625|NCT00013585|Drug|Selegiline hydrochloride|
12081626|NCT00013572|Biological|ALVAC-HIV MN120TMG (vCP205)|
12081627|NCT00013520|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
12081628|NCT00013520|Drug|Atazanavir|
12081629|NCT00013520|Drug|Lamivudine/Zidovudine|
12081630|NCT00013520|Drug|Abacavir sulfate|
12081631|NCT00013520|Drug|Efavirenz|
12081632|NCT00013520|Drug|Nevirapine|
12081633|NCT00013520|Drug|Lamivudine|
12081634|NCT00013520|Drug|Stavudine|
12081635|NCT00013520|Drug|Zidovudine|
12081636|NCT00013520|Drug|Didanosine|
12081637|NCT00012519|Drug|indinavir sulfate|
12081638|NCT00012519|Drug|ritonavir|
12081639|NCT00012467|Drug|Itraconazole|
12081640|NCT00012467|Drug|Flucytosine|
12081641|NCT00012467|Drug|Fluconazole|
12081642|NCT00012467|Drug|Amphotericin B|
12081643|NCT00012467|Drug|Interferon gamma-1b|
12081644|NCT00011895|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
12081645|NCT00011895|Drug|Efavirenz|
12081646|NCT00011479|Drug|Abacavir sulfate|
12081647|NCT00011128|Behavioral|Antiretroviral Treatment Interruption|
12081648|NCT00011089|Drug|Tenofovir disoproxil fumarate|
12081649|NCT00011037|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|1 x 10^ 7 TCID50 administered intramuscularly
12081650|NCT00011037|Biological|MN rgp120/HIV-1|0.6 mg administered intramuscularly
12081651|NCT00011037|Biological|ALVAC(2)120(B,MN)GNP (vCP1452) placebo|ALVAC placebo administered intramuscularly
12081652|NCT00011037|Biological|MN rgp120/HIV-1 placebo|Alum placebo administered intramuscularly
12081653|NCT00011011|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081654|NCT00009555|Drug|Testosterone|
12081655|NCT00009061|Drug|Ritonavir|
12081656|NCT00009061|Drug|Abacavir sulfate|
12081657|NCT00009061|Drug|Nelfinavir mesylate|
12081658|NCT00009061|Drug|Lamivudine|
12081659|NCT00009061|Drug|GW433908|
12081660|NCT00008866|Biological|Tetanus Toxoid Vaccine|
12081661|NCT00008866|Drug|Hydroxyurea|
12081662|NCT00008866|Drug|Didanosine|
12081663|NCT00008853|Biological|GBS III-TT-SSI|
12081664|NCT00008853|Biological|GBS III-TT-MPHL|
12081665|NCT00008554|Drug|Abacavir sulfate|
12081666|NCT00008554|Drug|Nelfinavir mesylate|
12081673|NCT00008463|Drug|Peginterferon alfa-2a|
12081674|NCT00007787|Biological|Cyclosporine|
12081675|NCT00007787|Biological|Anti-human thymocyte globulin (rabbit)|Anti-human thymocyte globulin (rabbit) will be given at a dose of 1.5 mg/kg while undergoing transplantation. Second and subsequent doses of Thymoglobulin® will be administered if, at 24 hours post-anastomosis, the serum creatinine has not decreased by at least 20% from the pre-transplant level. Additional Anti-human thymocyte globulin (rabbit) will be given at a dose of 1.5mg/kg daily for a minimum of 5 days to a maximum of 7 days.
12081676|NCT00007787|Drug|Tacrolimus|
12081677|NCT00007449|Drug|DPC 083|
12081678|NCT00007436|Drug|Tenofovir disoproxil fumarate|
12081679|NCT00007423|Biological|ALVAC-HIV MN120TMG (vCP205)|
12081680|NCT00007423|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12081681|NCT00007332|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081682|NCT00007332|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
12081683|NCT00007202|Drug|Atazanavir|
12081684|NCT00007202|Drug|Stavudine|
12081685|NCT00007202|Drug|Didanosine|
12081686|NCT00006630|Drug|Vaccinia Immune Globulin (Human)|
12081687|NCT00006617|Drug|Abacavir sulfate|
12081688|NCT00006617|Drug|Amprenavir|
12081689|NCT00006617|Drug|Lamivudine|
12081690|NCT00006617|Drug|Zidovudine|
12081691|NCT00006604|Drug|ATV|Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
12081692|NCT00006604|Drug|Ritonavir|Administered as 100 mg capsules or oral solution.
12081693|NCT00006591|Drug|Ritonavir|
12081694|NCT00006591|Drug|Amprenavir|
12081695|NCT00006578|Drug|Ritonavir|
12081696|NCT00006578|Drug|Abacavir sulfate|
12081697|NCT00006578|Drug|Amprenavir|
12081698|NCT00006578|Drug|Lamivudine|
12081699|NCT00006578|Drug|Filgrastim|
12081700|NCT00006509|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081701|NCT00006509|Biological|gp160 MN/LAI-2|
12081702|NCT00006495|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081703|NCT00006495|Biological|HIV-1 Immunogen|
12081704|NCT00006443|Drug|Indinavir sulfate|
12081705|NCT00006443|Drug|Nelfinavir mesylate|
12081706|NCT00006443|Drug|Lamivudine|
12081707|NCT00006443|Drug|Stavudine|
12081708|NCT00006441|Drug|Lamivudine/Zidovudine|300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.
12081709|NCT00006441|Drug|Nelfinavir mesylate|1250 mg twice daily for 104 weeks.
12081710|NCT00006441|Drug|Aldesleukin|7.5 million units twice daily. Treatment will last until conclusion of study.
12081711|NCT00006412|Drug|Pravastatin sodium|
12081712|NCT00006412|Drug|Fenofibrate|
12081713|NCT00006397|Drug|Indinavir sulfate|
12081714|NCT00006397|Drug|Ritonavir|
12081715|NCT00006397|Drug|Stavudine|
12081716|NCT00006397|Drug|Didanosine|
12081717|NCT00006396|Drug|Nevirapine|
12081718|NCT00006396|Drug|Zidovudine|
12081719|NCT00006339|Drug|Indinavir sulfate|
12081720|NCT00006339|Drug|Ritonavir|
12081721|NCT00006339|Drug|Hydroxyurea|
12081722|NCT00006339|Drug|Stavudine|
12081723|NCT00006339|Drug|Didanosine|
12081724|NCT00006327|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
12081725|NCT00006326|Drug|Indinavir sulfate|
12081726|NCT00006326|Drug|Ritonavir|
12081727|NCT00006326|Drug|Delavirdine mesylate|
12081728|NCT00006325|Drug|Peginterferon alfa-2b|
12081729|NCT00006324|Drug|Ethinyl estradiol/levonorgestrel|
12081730|NCT00006324|Drug|Medroxyprogesterone acetate|
12081731|NCT00006291|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081732|NCT00006291|Drug|Aldesleukin|
12081733|NCT00006279|Drug|Nevirapine|
12081734|NCT00006211|Drug|Capravirine|
12081735|NCT00006211|Drug|Nelfinavir mesylate|
12081736|NCT00006209|Drug|Tucaresol|
12081737|NCT00006208|Drug|Efavirenz|
12081738|NCT00006208|Drug|Emtricitabine|
12081739|NCT00006208|Drug|Stavudine|
12081740|NCT00006208|Drug|Didanosine|
12081741|NCT00006207|Drug|PRO 2000|
12081742|NCT00006154|Drug|Indinavir sulfate|400 mg tablets equaling 1600 mg daily
12081743|NCT00006154|Drug|Ritonavir|100 mg liquid capsules equaling 400 mg daily
12081744|NCT00006154|Drug|Abacavir sulfate|300 mg capsules equaling 600 mg daily. Administration based on individual results after 16 weeks.
12081745|NCT00006154|Drug|Efavirenz|200 mg capsules equaling 600 mg daily
12081746|NCT00006154|Drug|Stavudine|30-40 mg capsules equaling 60 or 80 mg daily
12081747|NCT00006154|Drug|Didanosine|250-400 mg E.coated tablets equaling 250 or 400 mg daily
12081748|NCT00006154|Drug|Aldesleukin|Subcutaneous injection equaling 15 x 10^6 IU daily dose. Administration based on individual results after 16 weeks and randomization.
12081749|NCT00006153|Biological|HIV-1 Immunogen|
12081750|NCT00006152|Drug|Ritonavir|
12081751|NCT00006152|Drug|Abacavir sulfate|
12081752|NCT00006152|Drug|Amprenavir|
12081753|NCT00006146|Biological|Approved influenza virus vaccine.|
12081754|NCT00006145|Drug|Valganciclovir|
12081755|NCT00006144|Drug|Lopinavir/Ritonavir|
12081756|NCT00006144|Drug|Emtricitabine|
12081757|NCT00006144|Drug|Stavudine|
12081758|NCT00006143|Drug|Somatropin|
12081759|NCT00006075|Drug|Chlorhexidine gluconate|
12081760|NCT00006066|Biological|Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed|
12081761|NCT00006066|Biological|Diphtheria and Tetanus Toxoids Adsorbed|
12081762|NCT00006066|Biological|Tetanus and Diphtheria Toxoids Adsorbed|
12081763|NCT00006066|Drug|Bacteriophage phi X 174|
12081764|NCT00006066|Drug|Aldesleukin|
12081765|NCT00005931|Drug|SU5416|
12081766|NCT00005921|Drug|L-743,872|
12081767|NCT00005920|Drug|L-743,872|
12081768|NCT00005918|Drug|Efavirenz|
12081772|NCT00005779|Biological|HIV-1 C4-V3 Polyvalent Peptide Vaccine|
12081773|NCT00005764|Drug|Lamivudine/Zidovudine|
12081774|NCT00005764|Drug|Abacavir sulfate|
12081775|NCT00005764|Drug|Lamivudine|
12081776|NCT00005762|Drug|Indinavir sulfate|
12081777|NCT00005762|Drug|Ritonavir|
12081778|NCT00005762|Drug|Amprenavir|
12081779|NCT00005762|Drug|Nelfinavir mesylate|
12081780|NCT00005762|Drug|Efavirenz|
12081781|NCT00005762|Drug|Saquinavir|
12081782|NCT00005758|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12081783|NCT00005758|Biological|HIV-1 Immunogen|
12081784|NCT00005668|Drug|Itraconazole oral solution|
12081785|NCT00005663|Drug|Valacyclovir hydrochloride|
12081786|NCT00005120|Drug|Calanolide A|
12081787|NCT00005118|Drug|Indinavir sulfate|
12081788|NCT00005118|Drug|Ritonavir|
12081789|NCT00005113|Drug|Cyclosporine|Oral tablet taken daily. Dosage is dependent on weight and is titrated to target trough level.
12081790|NCT00005113|Drug|Sirolimus|Dosage in liquid or tablet form is dependent on body surface area and is titrated to target trough level.
12081791|NCT00005113|Drug|Tacrolimus|dosage is in oral form titrated to target trough level
12081792|NCT00005106|Drug|Lamivudine/Zidovudine|
12081793|NCT00005106|Drug|Abacavir sulfate|
12081794|NCT00005106|Drug|Nelfinavir mesylate|
12081795|NCT00005106|Drug|Lamivudine|
12081796|NCT00005106|Drug|Stavudine|
12081797|NCT00005018|Drug|Hydroxyurea|
12081798|NCT00005018|Drug|Abacavir sulfate|
12081799|NCT00005018|Drug|Efavirenz|
12081800|NCT00005018|Drug|Didanosine|
12081801|NCT00005017|Drug|Ritonavir|
12081802|NCT00005017|Drug|Abacavir sulfate|
12081803|NCT00005017|Drug|Amprenavir|
12081804|NCT00005017|Drug|Efavirenz|
12081805|NCT00005017|Drug|Lamivudine|
12081806|NCT00005017|Drug|Stavudine|
12081807|NCT00005012|Drug|Peginterferon alfa-2b|
12081808|NCT00005010|Drug|Irbesartan|
12081809|NCT00005010|Drug|Pravastatin|
12081810|NCT00005009|Biological|Varivax®|Each participant will receive 2 doses of Varivax 6 to 8 weeks apart.
12081811|NCT00005002|Drug|Lamivudine/Zidovudine|
12081812|NCT00005002|Biological|HIV-1 Immunogen|
12081813|NCT00005002|Drug|Nelfinavir mesylate|
12081814|NCT00005001|Biological|HIV-1 Immunogen|
12081815|NCT00005000|Drug|Nelfinavir mesylate|
12081816|NCT00005000|Drug|Efavirenz|
12081817|NCT00005000|Drug|Lamivudine|
12081818|NCT00005000|Drug|Keyhole-Limpet Hemocyanin|
12081819|NCT00005000|Drug|Stavudine|
12081820|NCT00005000|Drug|Zidovudine|
12081821|NCT00005000|Drug|Didanosine|
12081822|NCT00004999|Drug|Lamivudine/Zidovudine|
12081823|NCT00004999|Drug|Capravirine|
12081824|NCT00004999|Drug|Nelfinavir mesylate|
12081825|NCT00004998|Drug|Lamivudine/Zidovudine|
12081826|NCT00004998|Drug|Capravirine|
12081827|NCT00004998|Drug|Nelfinavir mesylate|
12081828|NCT00004987|Drug|Dextrin 2-sulfate|
12081829|NCT00004986|Drug|Nitazoxanide|
12081830|NCT00004985|Drug|Capravirine|
12081831|NCT00004985|Drug|Nelfinavir mesylate|
12081832|NCT00004981|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
12081833|NCT00004981|Drug|Lamivudine/Zidovudine|
12081834|NCT00004981|Drug|Abacavir sulfate|
12081835|NCT00004978|Drug|Recombinant interleukin-2 (rIL-2)|Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.
12081836|NCT00004855|Drug|Lopinavir/Ritonavir|
12081837|NCT00004855|Drug|Abacavir sulfate|
12081838|NCT00004855|Drug|Nevirapine|
12081839|NCT00004855|Drug|Lamivudine|
12081840|NCT00004855|Drug|Stavudine|
12081841|NCT00004852|Drug|Efavirenz|
12081842|NCT00004852|Drug|Lamivudine|
12081843|NCT00004852|Drug|Zidovudine|
12081844|NCT00004736|Drug|Nelfinavir mesylate|
12081845|NCT00004736|Drug|Ethambutol hydrochloride|
12081846|NCT00004736|Drug|Isoniazid|
12081847|NCT00004736|Drug|Pyrazinamide|
12081848|NCT00004736|Drug|Lamivudine|
12081849|NCT00004736|Drug|Rifabutin|
12081850|NCT00004736|Drug|Stavudine|
12081851|NCT00004736|Drug|Zidovudine|
12081852|NCT00004735|Biological|Tetanus toxoid|
12081853|NCT00004735|Biological|Hepatitis A Vaccine (Inactivated)|
12081854|NCT00004585|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
12081855|NCT00004585|Drug|Lamivudine/Zidovudine|
12081856|NCT00004585|Drug|Abacavir sulfate|
12081857|NCT00004585|Drug|Efavirenz|
12081858|NCT00004584|Drug|Atazanavir|
12081859|NCT00004584|Drug|Ritonavir|
12081860|NCT00004584|Drug|Saquinavir|
12081861|NCT00004583|Drug|Lopinavir/Ritonavir|
12081862|NCT00004583|Drug|Nelfinavir mesylate|
12081863|NCT00004583|Drug|Lamivudine|
12081864|NCT00004583|Drug|Stavudine|
12081865|NCT00004582|Drug|Lopinavir/Ritonavir|
12081866|NCT00004582|Drug|Efavirenz|
12081867|NCT00004581|Drug|Lopinavir/Ritonavir|
12081868|NCT00004581|Drug|Nevirapine|
12081869|NCT00004580|Drug|Lopinavir/Ritonavir|
12081870|NCT00004580|Drug|Nevirapine|
12081871|NCT00004579|Biological|gp160 MN/LAI-2|
12081872|NCT00004579|Biological|ALVAC-HIV MN120TMG (vCP205)|
12081873|NCT00004578|Drug|Lopinavir/Ritonavir|Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
12081874|NCT00004578|Drug|Lamivudine|150 mg, every 12 hours
12081875|NCT00004578|Drug|Stavudine|40 mg every 12 hours
12081876|NCT00002453|Drug|Tenofovir disoproxil fumarate|
12081877|NCT00002452|Drug|L-756423|
12081878|NCT00002452|Drug|Indinavir sulfate|
12081879|NCT00002451|Drug|Indinavir sulfate|
12081880|NCT00002451|Drug|Ritonavir|
12081883|NCT00002450|Drug|Tenofovir disoproxil fumarate|
12081884|NCT00002449|Drug|Aldesleukin|
12081885|NCT00002448|Drug|Ritonavir|
12081886|NCT00002448|Drug|Efavirenz|
12081887|NCT00002448|Drug|Saquinavir|
12081888|NCT00002447|Drug|Ritonavir|
12081889|NCT00002447|Drug|Efavirenz|
12081890|NCT00002447|Drug|Saquinavir|
12081891|NCT00002446|Drug|Posaconazole|
12081892|NCT00002446|Drug|Fluconazole|
12081893|NCT00002445|Drug|IM862|
12081894|NCT00002444|Drug|Nitazoxanide|
12081895|NCT00002443|Drug|Indinavir sulfate|
12081896|NCT00002443|Drug|Zidovudine|
12081897|NCT00002442|Drug|Indinavir sulfate|
12081898|NCT00002442|Drug|Nelfinavir mesylate|
12081899|NCT00002442|Drug|Lamivudine|
12081900|NCT00002442|Drug|Stavudine|
12081901|NCT00002441|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
12081902|NCT00002440|Drug|Indinavir sulfate|
12081903|NCT00002440|Drug|Ritonavir|
12081904|NCT00002440|Drug|Abacavir sulfate|
12081905|NCT00002440|Drug|Amprenavir|
12081906|NCT00002440|Drug|Nelfinavir mesylate|
12081907|NCT00002440|Drug|Saquinavir|
12081908|NCT00002439|Drug|Alitretinoin|
12081909|NCT00002438|Drug|Itraconazole|
12081910|NCT00002437|Drug|Cidofovir|
12081911|NCT00002437|Drug|Probenecid|
12081912|NCT00002436|Drug|Lamivudine|
12081913|NCT00002436|Drug|Zidovudine|
12081914|NCT00002436|Drug|Zalcitabine|
12081915|NCT00002435|Drug|Thymic Humoral Factor|
12081916|NCT00002435|Drug|Zidovudine|
12081917|NCT00002434|Drug|Trimetrexate glucuronate|
12081918|NCT00002434|Drug|Leucovorin calcium|
12081919|NCT00002433|Drug|Interferon gamma-1b|
12081920|NCT00002432|Drug|Foscarnet sodium|
12081921|NCT00002431|Drug|Chlorhexidine gluconate|
12081922|NCT00002430|Drug|Indinavir sulfate|
12081923|NCT00002430|Drug|Nelfinavir mesylate|
12081924|NCT00002430|Drug|Lamivudine|
12081925|NCT00002430|Drug|Stavudine|
12081926|NCT00002429|Drug|Lamivudine/Zidovudine|
12081927|NCT00002429|Drug|Nelfinavir mesylate|
12081928|NCT00002429|Drug|Stavudine|
12081929|NCT00002429|Drug|Didanosine|
12081930|NCT00002428|Biological|HIV-1 Peptide Vaccine, Microparticulate Monovalent|
12081931|NCT00002428|Biological|rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine|
12081932|NCT00002427|Drug|Hydroxyurea|
12081933|NCT00002427|Drug|Stavudine|
12081934|NCT00002427|Drug|Didanosine|
12081935|NCT00002426|Drug|Adefovir dipivoxil|
12081936|NCT00002425|Drug|Saquinavir|
12081937|NCT00002424|Drug|L-756423|
12081938|NCT00002424|Drug|Indinavir sulfate|
12081939|NCT00002424|Drug|Lamivudine|
12081940|NCT00002424|Drug|Stavudine|
12081941|NCT00002423|Drug|Indinavir sulfate|
12081942|NCT00002423|Drug|Abacavir sulfate|
12081943|NCT00002423|Drug|Amprenavir|
12081944|NCT00002423|Drug|Nelfinavir mesylate|
12081945|NCT00002423|Drug|Lamivudine|
12081946|NCT00002422|Drug|HE2000|
12081947|NCT00002420|Drug|Emivirine|
12081948|NCT00002420|Drug|Hydroxyurea|
12081949|NCT00002420|Drug|Delavirdine mesylate|
12081950|NCT00002420|Drug|Stavudine|
12081951|NCT00002420|Drug|Didanosine|
12081952|NCT00002419|Drug|Abacavir sulfate|
12081953|NCT00002419|Drug|Amprenavir|
12081954|NCT00002419|Drug|Efavirenz|
12081955|NCT00002419|Drug|Adefovir dipivoxil|
12081956|NCT00002418|Drug|Emivirine|
12081957|NCT00002418|Drug|Hydroxyurea|
12081958|NCT00002418|Drug|Nevirapine|
12081959|NCT00002418|Drug|Stavudine|
12081960|NCT00002418|Drug|Didanosine|
12081961|NCT00002417|Drug|Amprenavir|
12081962|NCT00002416|Drug|Emtricitabine|
12081963|NCT00002416|Drug|Lamivudine|
12081964|NCT00002415|Drug|Tenofovir disoproxil fumarate|
12081965|NCT00002414|Drug|CPI-1189|
12081966|NCT00002413|Drug|Emivirine|
12081967|NCT00002412|Drug|Emivirine|
12081968|NCT00002412|Drug|Hydroxyurea|
12081969|NCT00002412|Drug|Stavudine|
12081970|NCT00002412|Drug|Didanosine|
12081971|NCT00002411|Drug|Nelfinavir mesylate|
12081972|NCT00002411|Drug|Lamivudine|
12081973|NCT00002411|Drug|Stavudine|
12081974|NCT00002411|Drug|Zidovudine|
12081975|NCT00002411|Drug|Didanosine|
12081976|NCT00002410|Drug|Indinavir sulfate|
12081977|NCT00002410|Drug|Lamivudine|
12081978|NCT00002410|Drug|Zidovudine|
12081979|NCT00002409|Drug|Lamivudine/Zidovudine|
12081980|NCT00002409|Drug|Abacavir sulfate|
12081981|NCT00002408|Drug|Crofelemer|
12081982|NCT00002407|Drug|Indinavir sulfate|
12081983|NCT00002407|Drug|Nevirapine|
12081984|NCT00002407|Drug|Lamivudine|
12081985|NCT00002407|Drug|Stavudine|
12081986|NCT00002407|Drug|Didanosine|
12081987|NCT00002406|Drug|Indinavir sulfate|
12081988|NCT00002405|Drug|Amprenavir|
12081989|NCT00002404|Drug|Valacyclovir hydrochloride|
12081990|NCT00002403|Drug|Zintevir|
12081991|NCT00002402|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
12081992|NCT00002402|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
12081993|NCT00002402|Biological|Aluminum hydroxide|
12081994|NCT00002401|Drug|Indinavir sulfate|
12081995|NCT00002401|Drug|Delavirdine mesylate|
12081996|NCT00002401|Drug|Lamivudine|
12081997|NCT00002401|Drug|Zidovudine|
12081998|NCT00002400|Drug|Indinavir sulfate|
12081999|NCT00002400|Drug|Delavirdine mesylate|
12082000|NCT00002400|Drug|Lamivudine|
12082001|NCT00002400|Drug|Zidovudine|
12082002|NCT00002399|Drug|Posaconazole|
12082003|NCT00002399|Drug|Fluconazole|
12082004|NCT00002398|Drug|Levocarnitine|
12082006|NCT00002397|Drug|Nelfinavir mesylate|
12082007|NCT00002397|Drug|Saquinavir|
12082008|NCT00002397|Drug|Lamivudine|
12082009|NCT00002397|Drug|Stavudine|
12082010|NCT00002396|Drug|Tenofovir disoproxil fumarate|
12082011|NCT00002395|Drug|Topotecan|
12082012|NCT00002394|Drug|Terbinafine hydrochloride|
12082013|NCT00002393|Drug|Indinavir sulfate|
12082014|NCT00002393|Drug|Efavirenz|
12082015|NCT00002392|Drug|Thalidomide|
12082016|NCT00002391|Drug|Abacavir sulfate|
12082017|NCT00002391|Drug|Lamivudine|
12082018|NCT00002391|Drug|Zidovudine|
12082019|NCT00002390|Drug|Abacavir sulfate|
12082020|NCT00002389|Drug|Abacavir sulfate|
12082021|NCT00002389|Drug|Lamivudine|
12082022|NCT00002389|Drug|Zidovudine|
12082023|NCT00002388|Drug|Abacavir sulfate|
12082024|NCT00002387|Drug|Indinavir sulfate|
12082025|NCT00002387|Drug|Efavirenz|
12082026|NCT00002386|Drug|Indinavir sulfate|
12082027|NCT00002386|Drug|Lamivudine|
12082028|NCT00002386|Drug|Stavudine|
12082029|NCT00002386|Drug|Zidovudine|
12082030|NCT00002386|Drug|Zalcitabine|
12082031|NCT00002386|Drug|Didanosine|
12082032|NCT00002385|Drug|Fozivudine tidoxil|
12082033|NCT00002384|Drug|Cidofovir|
12082034|NCT00002383|Drug|Saquinavir|
12082035|NCT00002382|Drug|Saquinavir|
12082036|NCT00002381|Drug|Nelfinavir mesylate|
12082037|NCT00002381|Drug|Nevirapine|
12082038|NCT00002381|Drug|Stavudine|
12082039|NCT00002380|Drug|Nelfinavir mesylate|
12082040|NCT00002380|Drug|Saquinavir|
12082041|NCT00002379|Drug|Indinavir sulfate|
12082042|NCT00002379|Drug|Levocarnitine|
12082043|NCT00002379|Drug|Adefovir dipivoxil|
12082044|NCT00002379|Drug|Lamivudine|
12082045|NCT00002379|Drug|Stavudine|
12082046|NCT00002379|Drug|Zidovudine|
12082047|NCT00002378|Drug|Ritonavir|
12082048|NCT00002378|Drug|Nelfinavir mesylate|
12082049|NCT00002378|Drug|Saquinavir|
12082050|NCT00002378|Drug|Delavirdine mesylate|
12082051|NCT00002378|Drug|Lamivudine|
12082052|NCT00002378|Drug|Stavudine|
12082053|NCT00002378|Drug|Zidovudine|
12082054|NCT00002377|Drug|Valganciclovir|
12082055|NCT00002377|Drug|Ganciclovir|
12082056|NCT00002376|Drug|Indinavir sulfate|
12082057|NCT00002376|Drug|Lamivudine|
12082058|NCT00002376|Drug|Stavudine|
12082059|NCT00002376|Drug|Zidovudine|
12082060|NCT00002376|Drug|Didanosine|
12082061|NCT00002375|Drug|Indinavir sulfate|
12082062|NCT00002375|Drug|Nelfinavir mesylate|
12082063|NCT00002374|Drug|Ritonavir|
12082064|NCT00002374|Drug|Nelfinavir mesylate|
12082065|NCT00002374|Drug|Saquinavir|
12082066|NCT00002374|Drug|Stavudine|
12082067|NCT00002373|Drug|Maribavir|
12082068|NCT00002372|Drug|Indinavir sulfate|
12082069|NCT00002372|Drug|Amprenavir|
12082070|NCT00002372|Drug|Nelfinavir mesylate|
12082071|NCT00002372|Drug|Saquinavir|
12082072|NCT00002371|Drug|Indinavir sulfate|
12082073|NCT00002371|Drug|Lamivudine|
12082074|NCT00002371|Drug|Stavudine|
12082075|NCT00002371|Drug|Zidovudine|
12082076|NCT00002370|Drug|Itraconazole|
12082077|NCT00002369|Drug|Indinavir sulfate|
12082078|NCT00002369|Drug|Lamivudine|
12082079|NCT00002369|Drug|Stavudine|
12082080|NCT00002369|Drug|Zidovudine|
12082081|NCT00002368|Drug|Nevirapine|
12082082|NCT00002368|Drug|Lamivudine|
12082083|NCT00002367|Drug|Saquinavir|
12082084|NCT00002367|Drug|Lamivudine|
12082085|NCT00002367|Drug|Zidovudine|
12082086|NCT00002366|Drug|Ritonavir|
12082087|NCT00002365|Drug|LXR015-1|
12082088|NCT00002364|Drug|Abacavir sulfate|
12082089|NCT00002363|Drug|Peptide Construction 3, Synthetic|
12082090|NCT00002362|Drug|Abacavir sulfate|
12082091|NCT00002362|Drug|Efavirenz|
12082092|NCT00002362|Drug|Emtricitabine|
12082093|NCT00002362|Drug|Stavudine|
12082094|NCT00002361|Drug|Indinavir sulfate|
12082095|NCT00002361|Drug|Ritonavir|
12082096|NCT00002360|Drug|Didanosine|
12082097|NCT00002359|Biological|HIV-1 Immunogen|
12082098|NCT00002358|Drug|Sorivudine|
12082099|NCT00002357|Drug|HBY 097|
12082100|NCT00002357|Drug|Zidovudine|
12082101|NCT00002356|Drug|Fomivirsen sodium|
12082102|NCT00002355|Drug|Fomivirsen sodium|
12082103|NCT00002354|Drug|Indinavir sulfate|
12082104|NCT00002354|Drug|Stavudine|
12082105|NCT00002353|Biological|P3C541b Lipopeptide|
12082106|NCT00002352|Drug|Lobucavir|
12082107|NCT00002351|Drug|Indinavir sulfate|
12082108|NCT00002350|Biological|APL 400-003|
12082109|NCT00002349|Drug|Stavudine|
12082110|NCT00002348|Drug|Mitoguazone|
12082111|NCT00002347|Drug|Saquinavir|
12082112|NCT00002347|Drug|Nevirapine|
12082113|NCT00002347|Drug|Zidovudine|
12082114|NCT00002347|Drug|Zalcitabine|
12082115|NCT00002346|Drug|Adefovir dipivoxil|
12082116|NCT00002345|Drug|Megestrol acetate|
12082117|NCT00002344|Drug|Azithromycin|
12082118|NCT00002343|Drug|Ethambutol hydrochloride|
12082119|NCT00002343|Drug|Rifabutin|
12082120|NCT00002342|Drug|Tecogalan sodium|
12082121|NCT00002341|Drug|Itraconazole|
12082122|NCT00002340|Drug|Atovaquone|
12082123|NCT00002340|Drug|Pentamidine isethionate|
12082124|NCT00002339|Drug|Fluconazole|
12082125|NCT00002338|Drug|Raluridine|
12082126|NCT00002337|Drug|Vesnarinone|
12082127|NCT00002336|Drug|Clarithromycin|
12082128|NCT00002335|Drug|Emtricitabine|
12082129|NCT00002334|Drug|Saquinavir|
12082130|NCT00002334|Drug|Zidovudine|
12082131|NCT00002334|Drug|Zalcitabine|
12082135|NCT00002331|Drug|Ethambutol hydrochloride|
12082136|NCT00002331|Drug|Clarithromycin|
12082137|NCT00002331|Drug|Clofazimine|
12082138|NCT00002330|Drug|Ganciclovir|
12082139|NCT00002329|Drug|Celgosivir hydrochloride|
12082140|NCT00002328|Drug|Azithromycin|
12082141|NCT00002327|Drug|Cidofovir|
12082142|NCT00002326|Drug|Adefovir|
12082143|NCT00002326|Drug|Zidovudine|
12082144|NCT00002325|Drug|Fluconazole|
12082145|NCT00002324|Drug|Nevirapine|
12082146|NCT00002324|Drug|Zidovudine|
12082147|NCT00002323|Drug|Nevirapine|
12082148|NCT00002323|Drug|Zidovudine|
12082149|NCT00002322|Drug|Atevirdine mesylate|
12082150|NCT00002322|Drug|Zidovudine|
12082151|NCT00002321|Drug|Aldesleukin|
12082152|NCT00002320|Drug|Lamivudine|
12082153|NCT00002320|Drug|Zidovudine|
12082154|NCT00002319|Drug|Doxorubicin hydrochloride (liposomal)|
12082155|NCT00002318|Drug|Doxorubicin hydrochloride (liposomal)|
12082156|NCT00002318|Drug|Bleomycin sulfate|
12082157|NCT00002318|Drug|Vincristine sulfate|
12082158|NCT00002318|Drug|Doxorubicin hydrochloride|
12082159|NCT00002317|Drug|Trimetrexate glucuronate|
12082160|NCT00002317|Drug|Leucovorin calcium|
12082161|NCT00002316|Drug|Lobradimil|
12082162|NCT00002316|Drug|Amphotericin B|
12082163|NCT00002315|Drug|Netivudine|
12082164|NCT00002315|Drug|Acyclovir|
12082165|NCT00002314|Drug|Ro 24-7429|
12082166|NCT00002313|Drug|Nystatin|
12082167|NCT00002313|Drug|Didanosine|
12082168|NCT00002312|Drug|Delavirdine mesylate|
12082169|NCT00002312|Drug|Zidovudine|
12082170|NCT00002311|Drug|Wobenzym|
12082171|NCT00002310|Drug|Crofelemer|
12082172|NCT00002309|Drug|Azithromycin|
12082173|NCT00002308|Drug|Stavudine|
12082174|NCT00002307|Drug|Stavudine|
12082175|NCT00002307|Drug|Zidovudine|
12082176|NCT00002306|Drug|Fluconazole|
12082177|NCT00002305|Drug|Flucytosine|
12082178|NCT00002305|Drug|Fluconazole|
12082179|NCT00002305|Drug|Amphotericin B|
12082180|NCT00002304|Drug|Ketoconazole|
12082181|NCT00002304|Drug|Fluconazole|
12082182|NCT00002303|Drug|Epoetin alfa|
12082183|NCT00002302|Drug|Epoetin alfa|
12082184|NCT00002301|Drug|Foscarnet sodium|
12082185|NCT00002300|Drug|Megestrol acetate|
12082186|NCT00002299|Drug|Interferon beta-1b|
12082187|NCT00002299|Drug|Ganciclovir|
12082188|NCT00002298|Drug|Ribavirin|
12082189|NCT00002297|Drug|Inosine pranobex|
12082190|NCT00002296|Drug|Inosine pranobex|
12082191|NCT00002295|Drug|Inosine pranobex|
12082192|NCT00002294|Drug|Fluconazole|
12082193|NCT00002293|Drug|Nystatin|
12082194|NCT00002292|Drug|Pentamidine isethionate|
12082195|NCT00002291|Drug|Pentamidine isethionate|
12082196|NCT00002290|Drug|Zidovudine|
12082197|NCT00002290|Drug|Acyclovir|
12082198|NCT00002289|Drug|Thymopentin|
12082199|NCT00002288|Drug|Zidovudine|
12082200|NCT00002287|Drug|Zidovudine|
12082201|NCT00002286|Drug|Zidovudine|
12082202|NCT00002285|Drug|Zidovudine|
12082203|NCT00002284|Drug|Zidovudine|
12082204|NCT00002283|Drug|Trimethoprim|
12082205|NCT00002283|Drug|Sulfamethoxazole|
12082206|NCT00002283|Drug|Dapsone|
12082207|NCT00002282|Drug|Clotrimazole|
12082208|NCT00002282|Drug|Fluconazole|
12082209|NCT00002281|Drug|Filgrastim|
12082210|NCT00002281|Drug|Epoetin alfa|
12082211|NCT00002281|Drug|Zidovudine|
12082212|NCT00002280|Drug|Didanosine|
12082213|NCT00002279|Drug|Zalcitabine|
12082214|NCT00002278|Drug|Diclazuril|
12082215|NCT00002277|Drug|Fluconazole|
12082216|NCT00002277|Drug|Amphotericin B|
12082217|NCT00002276|Drug|Ibuprofen|
12082218|NCT00002276|Drug|Zidovudine|
12082219|NCT00002275|Drug|Fat Emulsion 2%|
12082220|NCT00002275|Drug|Fat Emulsion 20%|
12082221|NCT00002274|Drug|Didanosine|
12082222|NCT00002273|Drug|Ganciclovir|
12082223|NCT00002272|Drug|Foscarnet sodium|
12082224|NCT00002271|Drug|Alovudine|
12082225|NCT00002270|Drug|Interferon alfa-2b|
12082226|NCT00002270|Drug|Zidovudine|
12082227|NCT00002269|Drug|Ampligen|
12082228|NCT00002269|Drug|Zidovudine|
12082229|NCT00002268|Drug|Sevirumab|
12082230|NCT00002267|Drug|Rifabutin|
12082231|NCT00002266|Drug|AS-101|
12082232|NCT00002265|Drug|Zalcitabine|
12082233|NCT00002264|Drug|Cryptosporidium Immune Whey Protein Concentrate (Bovine)|
12082234|NCT00002263|Drug|Zidovudine|
12082235|NCT00002263|Drug|Sargramostim|
12082236|NCT00002262|Drug|Tumor Necrosis Factor|
12082237|NCT00002261|Biological|Smallpox Vaccine|
12082238|NCT00002261|Biological|HIVAC-1e|
12082239|NCT00002261|Biological|gp160 Vaccine (MicroGeneSys)|
12082240|NCT00002260|Drug|Alovudine|
12082241|NCT00002259|Drug|Mitoxantrone hydrochloride|
12082242|NCT00002258|Drug|Interleukin-3|
12082243|NCT00002257|Drug|Ganciclovir|
12082244|NCT00002256|Drug|Zalcitabine|
12082245|NCT00002255|Drug|Filgrastim|
12082246|NCT00002255|Drug|Epoetin alfa|
12082247|NCT00002255|Drug|Zidovudine|
12082248|NCT00002254|Drug|Alovudine|
12082249|NCT00002253|Drug|Octreotide|
12082250|NCT00002252|Drug|Octreotide|
12082251|NCT00002251|Drug|Ganciclovir|
12082252|NCT00002250|Drug|CD4-IgG|
12082253|NCT00002249|Drug|Levofloxacin|
12082254|NCT00002248|Drug|Cryptosporidium Immune Whey Protein Concentrate (Bovine)|
12082255|NCT00002247|Drug|Ganciclovir|
12082256|NCT00002246|Drug|Stavudine|
12082257|NCT00002245|Drug|Abacavir sulfate|
12082267|NCT00002240|Drug|Nelfinavir mesylate|
12082268|NCT00002240|Drug|Stavudine|
12082269|NCT00002240|Drug|Didanosine|
12082270|NCT00002239|Drug|Enfuvirtide|
12082271|NCT00002239|Drug|Ritonavir|
12082272|NCT00002239|Drug|Abacavir sulfate|
12082273|NCT00002239|Drug|Amprenavir|
12082274|NCT00002239|Drug|Efavirenz|
12082275|NCT00002238|Drug|Interferon beta-1b|
12082276|NCT00002238|Drug|Zidovudine|
12082277|NCT00002237|Drug|Peldesine|
12082278|NCT00002236|Drug|Indinavir sulfate|
12082279|NCT00002236|Drug|Delavirdine mesylate|
12082280|NCT00002236|Drug|Zidovudine|
12082281|NCT00002235|Drug|Indinavir sulfate|
12082282|NCT00002235|Drug|Nelfinavir mesylate|
12082283|NCT00002235|Drug|Efavirenz|
12082284|NCT00002234|Drug|Efavirenz|
12082285|NCT00002234|Drug|Adefovir dipivoxil|
12082286|NCT00002234|Drug|Lamivudine|
12082287|NCT00002234|Drug|Didanosine|
12082288|NCT00002233|Drug|Indinavir sulfate|
12082289|NCT00002233|Drug|Abacavir sulfate|
12082290|NCT00002233|Drug|Amprenavir|
12082291|NCT00002233|Drug|Lamivudine|
12082292|NCT00002232|Biological|APL 400-003|
12082293|NCT00002231|Biological|APL 400-003|
12082294|NCT00002230|Drug|Hydroxyurea|
12082295|NCT00002230|Drug|Efavirenz|
12082296|NCT00002230|Drug|Stavudine|
12082297|NCT00002230|Drug|Didanosine|
12082298|NCT00002229|Drug|Saquinavir|
12082299|NCT00002228|Drug|Enfuvirtide|
12082300|NCT00002227|Drug|Efavirenz|
12082301|NCT00002227|Drug|Lamivudine|
12082302|NCT00002227|Drug|Stavudine|
12082303|NCT00002226|Drug|SU5416|
12082304|NCT00002225|Drug|Efavirenz|
12082305|NCT00002225|Drug|Stavudine|
12082306|NCT00002225|Drug|Didanosine|
12082307|NCT00002224|Drug|Nelfinavir mesylate|
12082308|NCT00002224|Drug|Stavudine|
12082309|NCT00002224|Drug|Didanosine|
12082310|NCT00002223|Drug|Indinavir sulfate|
12082311|NCT00002223|Drug|Ritonavir|
12082312|NCT00002222|Drug|Valganciclovir|
12082313|NCT00002221|Drug|Peripheral blood stem cells|
12082314|NCT00002220|Drug|Indinavir sulfate|
12082315|NCT00002220|Drug|Efavirenz|
12082316|NCT00002220|Drug|Levocarnitine|
12082317|NCT00002220|Drug|Adefovir dipivoxil|
12082318|NCT00002219|Drug|Nelfinavir mesylate|
12082319|NCT00002219|Drug|Levocarnitine|
12082320|NCT00002219|Drug|Adefovir dipivoxil|
12082321|NCT00002218|Drug|CI-1012|
12082322|NCT00002217|Drug|Lamivudine/Zidovudine|
12082323|NCT00002217|Drug|Abacavir sulfate|
12082324|NCT00002217|Drug|Amprenavir|
12082325|NCT00002216|Drug|Lamivudine/Zidovudine|
12082326|NCT00002216|Drug|Abacavir sulfate|
12082327|NCT00002216|Drug|Amprenavir|
12082328|NCT00002216|Drug|Nelfinavir mesylate|
12082329|NCT00002215|Drug|Emivirine|
12082330|NCT00002215|Drug|Nelfinavir mesylate|
12082331|NCT00002214|Drug|Capravirine|
12082332|NCT00002213|Drug|Abacavir sulfate|
12082333|NCT00002213|Drug|Amprenavir|
12082334|NCT00002213|Drug|Efavirenz|
12082335|NCT00002212|Drug|Bexarotene|
12082336|NCT00002211|Drug|Nelfinavir mesylate|
12082337|NCT00002211|Drug|Delavirdine mesylate|
12082338|NCT00002211|Drug|Stavudine|
12082339|NCT00002211|Drug|Didanosine|
12082340|NCT00002210|Drug|Delavirdine mesylate|
12082341|NCT00002209|Drug|CPI-1189|
12082342|NCT00002208|Drug|Indinavir sulfate|
12082343|NCT00002208|Drug|Lamivudine|
12082344|NCT00002208|Drug|Stavudine|
12082345|NCT00002208|Drug|Zidovudine|
12082346|NCT00002207|Drug|Stavudine|
12082347|NCT00002207|Drug|Didanosine|
12082348|NCT00002206|Drug|Adefovir dipivoxil|
12082349|NCT00002205|Drug|Abacavir sulfate|
12082350|NCT00002205|Drug|Amprenavir|
12082351|NCT00002204|Biological|HIV p24/MF59 Vaccine|
12082352|NCT00002203|Drug|Lamivudine/Zidovudine|
12082353|NCT00002203|Drug|Lamivudine|
12082354|NCT00002203|Drug|Zidovudine|
12082355|NCT00002202|Drug|Indinavir sulfate|
12082356|NCT00002202|Drug|Amprenavir|
12082357|NCT00002201|Drug|Ritonavir|
12082358|NCT00002201|Drug|Nelfinavir mesylate|
12082359|NCT00002200|Drug|Abacavir sulfate|
12082360|NCT00002199|Drug|Indinavir sulfate|
12082361|NCT00002199|Drug|Lamivudine/Zidovudine|
12082362|NCT00002199|Drug|Abacavir sulfate|
12082363|NCT00002198|Drug|Abacavir sulfate|
12082364|NCT00002197|Drug|Abacavir sulfate|
12082365|NCT00002196|Drug|CI-1012|
12082366|NCT00002195|Drug|Amprenavir|
12082367|NCT00002195|Drug|Lamivudine|
12082368|NCT00002195|Drug|Zidovudine|
12082369|NCT00002194|Drug|Erythromycin|
12082370|NCT00002194|Drug|Nevirapine|
12082371|NCT00002194|Drug|Clarithromycin|
12082372|NCT00002193|Drug|Amprenavir|
12082373|NCT00002192|Drug|Rifapentine|
12082374|NCT00002192|Drug|Ethambutol hydrochloride|
12082375|NCT00002192|Drug|Clarithromycin|
12082376|NCT00002192|Drug|Azithromycin|
12082377|NCT00002191|Drug|Albendazole|
12082378|NCT00002190|Drug|Saquinavir|
12082379|NCT00002190|Drug|Lamivudine|
12082380|NCT00002190|Drug|Zidovudine|
12082381|NCT00002189|Drug|Paclitaxel|
12082382|NCT00002188|Drug|Alitretinoin|
12082383|NCT00002187|Drug|Fomivirsen sodium|
12082384|NCT00002186|Drug|Crofelemer|
12082385|NCT00002186|Drug|Acyclovir|
12082386|NCT00002185|Drug|Nelfinavir mesylate|
12082387|NCT00002184|Drug|Nelfinavir mesylate|
12082388|NCT00002184|Drug|Levocarnitine|
12082389|NCT00002184|Drug|Adefovir dipivoxil|
12082390|NCT00002184|Drug|Saquinavir|
12082391|NCT00002184|Drug|Lamivudine|
12082405|NCT00002178|Drug|Nelfinavir mesylate|
12082406|NCT00002178|Drug|Saquinavir|
12082407|NCT00002178|Drug|Delavirdine mesylate|
12082408|NCT00002177|Drug|Hydroxyurea|
12082409|NCT00002177|Drug|Nelfinavir mesylate|
12082410|NCT00002177|Drug|Stavudine|
12082411|NCT00002177|Drug|Didanosine|
12082412|NCT00002176|Drug|Hydroxyurea|
12082413|NCT00002176|Drug|Nelfinavir mesylate|
12082414|NCT00002176|Drug|Stavudine|
12082415|NCT00002176|Drug|Didanosine|
12082416|NCT00002175|Drug|Dinitrochlorobenzene|
12082417|NCT00002174|Drug|Thalidomide|
12082418|NCT00002173|Biological|HIV-1 Immunogen|
12082419|NCT00002172|Biological|HIV-1 Immunogen|
12082420|NCT00002171|Drug|Nelfinavir mesylate|
12082421|NCT00002170|Drug|Nelfinavir mesylate|
12082422|NCT00002169|Drug|Nelfinavir mesylate|
12082423|NCT00002168|Drug|Indinavir sulfate|
12082424|NCT00002168|Drug|Lamivudine|
12082425|NCT00002168|Drug|Stavudine|
12082426|NCT00002168|Drug|Zidovudine|
12082427|NCT00002168|Drug|Didanosine|
12082428|NCT00002167|Drug|Tin ethyl etiopurpurin|
12082429|NCT00002166|Drug|Nevirapine|
12082430|NCT00002165|Drug|Nelfinavir mesylate|
12082431|NCT00002164|Drug|Nelfinavir mesylate|
12082432|NCT00002163|Drug|Abacavir sulfate|
12082433|NCT00002162|Drug|Saquinavir|
12082434|NCT00002162|Drug|Lamivudine|
12082435|NCT00002162|Drug|Stavudine|
12082436|NCT00002162|Drug|Zidovudine|
12082437|NCT00002162|Drug|Zalcitabine|
12082438|NCT00002162|Drug|Didanosine|
12082439|NCT00002161|Drug|Adefovir dipivoxil|
12082440|NCT00002160|Drug|Ziconotide|
12082441|NCT00002159|Drug|Itraconazole|
12082442|NCT00002159|Drug|Amphotericin B|
12082443|NCT00002158|Drug|Nitazoxanide|
12082444|NCT00002157|Drug|Thalidomide|
12082445|NCT00002156|Drug|Fomivirsen sodium|
12082446|NCT00002156|Drug|Ganciclovir|
12082447|NCT00002155|Drug|Indinavir sulfate|
12082448|NCT00002155|Drug|Lamivudine|
12082449|NCT00002155|Drug|Zidovudine|
12082450|NCT00002154|Drug|Thioctic acid|
12082451|NCT00002154|Drug|Selegiline hydrochloride|
12082452|NCT00002153|Drug|A-007|
12082453|NCT00002152|Drug|WF10|
12082454|NCT00002151|Drug|Celgosivir hydrochloride|
12082455|NCT00002150|Drug|Celgosivir hydrochloride|
12082456|NCT00002149|Drug|Clavulanate potassium|
12082457|NCT00002149|Drug|Pseudoephedrine hydrochloride|
12082458|NCT00002149|Drug|Amoxicillin trihydrate|
12082459|NCT00002148|Drug|OPC 14117|
12082460|NCT00002147|Drug|Doxorubicin hydrochloride (liposomal)|
12082461|NCT00002146|Drug|Magnesium sulfate|
12082462|NCT00002146|Drug|Foscarnet sodium|
12082463|NCT00002145|Drug|Foscarnet sodium|
12082464|NCT00002144|Drug|Foscarnet sodium|
12082465|NCT00002143|Drug|Acitretin|
12082466|NCT00002142|Drug|Cidofovir|
12082467|NCT00002142|Drug|Probenecid|
12082468|NCT00002141|Drug|Abacavir sulfate|
12082469|NCT00002140|Drug|Ethambutol hydrochloride|
12082470|NCT00002140|Drug|Clarithromycin|
12082471|NCT00002140|Drug|Azithromycin|
12082472|NCT00002139|Drug|Azithromycin|
12082473|NCT00002138|Drug|Tecogalan sodium|
12082474|NCT00002137|Drug|Tecogalan sodium|
12082475|NCT00002136|Drug|Tecogalan sodium|
12082476|NCT00002135|Drug|Ganciclovir|
12082477|NCT00002134|Drug|Ganciclovir|
12082478|NCT00002133|Drug|Itraconazole|
12082479|NCT00002132|Drug|Itraconazole|
12082480|NCT00002132|Drug|Fluconazole|
12082481|NCT00002131|Drug|Vesnarinone|
12082482|NCT00002130|Drug|Vesnarinone|
12082483|NCT00002129|Drug|Vesnarinone|
12082484|NCT00002128|Drug|Adefovir dipivoxil|
12082485|NCT00002127|Drug|Thalidomide|
12082486|NCT00002126|Drug|Filgrastim|
12082487|NCT00002125|Drug|Foscarnet sodium|
12082488|NCT00002124|Drug|Delavirdine mesylate|
12082489|NCT00002124|Drug|Lamivudine|
12082490|NCT00002124|Drug|Zidovudine|
12082491|NCT00002123|Drug|Delavirdine mesylate|
12082492|NCT00002123|Drug|Didanosine|
12082493|NCT00002122|Drug|Azithromycin|
12082494|NCT00002122|Drug|Rifabutin|
12082495|NCT00002122|Drug|Fluconazole|
12082496|NCT00002121|Drug|Diethylhomospermine|
12082497|NCT00002120|Drug|Trimetrexate glucuronate|
12082498|NCT00002120|Drug|Trimethoprim|
12082499|NCT00002120|Drug|Sulfamethoxazole|
12082500|NCT00002120|Drug|Dapsone|
12082501|NCT00002120|Drug|Leucovorin calcium|
12082502|NCT00002119|Drug|WF10|
12082503|NCT00002118|Drug|Zalcitabine|
12082504|NCT00002117|Drug|Zidovudine|
12082505|NCT00002117|Drug|Zalcitabine|
12082506|NCT00002116|Drug|Cidofovir|
12082507|NCT00002115|Drug|Adefovir|
12082508|NCT00002114|Drug|Procysteine|
12082509|NCT00002113|Drug|Flucytosine|
12082510|NCT00002113|Drug|Fluconazole|
12082511|NCT00002112|Drug|Nystatin|
12082512|NCT00002112|Drug|Fluconazole|
12082513|NCT00002111|Drug|Saquinavir|
12082514|NCT00002110|Drug|Cysteamine|
12082515|NCT00002110|Drug|Zidovudine|
12082516|NCT00002109|Drug|Thymopentin|
12082517|NCT00002109|Drug|Stavudine|
12082518|NCT00002109|Drug|Zidovudine|
12082519|NCT00002109|Drug|Zalcitabine|
12082520|NCT00002109|Drug|Didanosine|
12082521|NCT00002108|Drug|Lamivudine|
12082522|NCT00002108|Drug|Zidovudine|
12082523|NCT00002107|Drug|Aldesleukin|
12082524|NCT00002106|Drug|Ranitidine hydrochloride|
12082525|NCT00002105|Drug|Doxorubicin hydrochloride (liposomal)|
12082527|NCT00002105|Drug|Vincristine sulfate|
12082528|NCT00002104|Drug|Thalidomide|
12082529|NCT00002103|Drug|Trimetrexate glucuronate|
12082530|NCT00002103|Drug|Leucovorin calcium|
12082531|NCT00002102|Drug|Trimetrexate glucuronate|
12082532|NCT00002102|Drug|Leucovorin calcium|
12082533|NCT00002101|Drug|Ethambutol hydrochloride|
12082534|NCT00002101|Drug|Clarithromycin|
12082535|NCT00002101|Drug|Rifabutin|
12082536|NCT00002100|Drug|Curdlan sulfate|
12082537|NCT00002099|Drug|Lentinan|
12082538|NCT00002099|Drug|Didanosine|
12082539|NCT00002098|Drug|Lentinan|
12082540|NCT00002098|Drug|Didanosine|
12082541|NCT00002097|Drug|Nystatin|
12082542|NCT00002096|Drug|Zidovudine|
12082543|NCT00002096|Drug|Didanosine|
12082544|NCT00002096|Drug|Ganciclovir|
12082545|NCT00002095|Drug|Ganciclovir|
12082546|NCT00002094|Drug|Atevirdine mesylate|
12082547|NCT00002093|Drug|Daunorubicin (liposomal)|
12082548|NCT00002093|Drug|Bleomycin sulfate|
12082549|NCT00002093|Drug|Vincristine sulfate|
12082550|NCT00002093|Drug|Doxorubicin hydrochloride|
12082551|NCT00002092|Drug|Cimetidine|
12082552|NCT00002091|Drug|Pentoxifylline|
12082553|NCT00002090|Drug|Azithromycin|
12082554|NCT00002089|Drug|Azithromycin|
12082555|NCT00002088|Drug|Saccharomyces boulardii|
12082556|NCT00002087|Drug|Alvircept sudotox|
12082557|NCT00002086|Drug|Zidovudine|
12082558|NCT00002086|Drug|Zalcitabine|
12082559|NCT00002086|Drug|Interferon alfa-n1|
12082560|NCT00002085|Drug|Azithromycin|
12082561|NCT00002084|Drug|Valacyclovir hydrochloride|
12082562|NCT00002084|Drug|Acyclovir|
12082563|NCT00002083|Drug|Peptide T|
12082564|NCT00002082|Drug|Azithromycin|
12082565|NCT00002081|Drug|Zidovudine|
12082566|NCT00002081|Drug|Zalcitabine|
12082567|NCT00002080|Drug|Rifabutin|
12082568|NCT00002079|Drug|Butyldeoxynojirimycin|
12082569|NCT00002079|Drug|Zidovudine|
12082570|NCT00002078|Drug|Interferon alfa-n3|
12082571|NCT00002077|Drug|Fluconazole|
12082572|NCT00002076|Drug|Fluconazole|
12082573|NCT00002075|Drug|Flucytosine|
12082574|NCT00002075|Drug|Fluconazole|
12082575|NCT00002075|Drug|Amphotericin B|
12082576|NCT00002074|Drug|Fluconazole|
12082577|NCT00002074|Drug|Amphotericin B|
12082578|NCT00002073|Drug|Epoetin alfa|
12082579|NCT00002072|Drug|Epoetin alfa|
12082580|NCT00002071|Drug|Epoetin alfa|
12082581|NCT00002070|Drug|Sargramostim|
12082582|NCT00002070|Drug|Ganciclovir|
12082583|NCT00002069|Drug|Ditiocarb sodium|
12082584|NCT00002068|Drug|Fluconazole|
12082585|NCT00002068|Drug|Amphotericin B|
12082586|NCT00002067|Drug|Megestrol acetate|
12082587|NCT00002066|Drug|Thymopentin|
12082588|NCT00002065|Drug|Disulfiram|
12082589|NCT00002064|Drug|Pyrimethamine|
12082590|NCT00002064|Drug|Clindamycin|
12082591|NCT00002063|Drug|Zidovudine|
12082592|NCT00002062|Drug|Spiramycin|
12082593|NCT00002061|Drug|Inosine pranobex|
12082594|NCT00002060|Drug|Inosine pranobex|
12082595|NCT00002059|Drug|Inosine pranobex|
12082596|NCT00002058|Drug|Clofazimine|
12082597|NCT00002057|Drug|Nystatin|
12082598|NCT00002056|Drug|Pentamidine isethionate|
12082599|NCT00002055|Drug|Pentamidine isethionate|
12082600|NCT00002054|Drug|Pentamidine isethionate|
12082601|NCT00002053|Drug|Pentamidine isethionate|
12082602|NCT00002052|Drug|Ceftriaxone sodium|
12082603|NCT00002052|Drug|Ampicillin sodium|
12082604|NCT00002052|Drug|Amoxicillin trihydrate|
12082605|NCT00002051|Drug|Thymopentin|
12082606|NCT00002050|Drug|Thymopentin|
12082607|NCT00002049|Drug|Thymopentin|
12082608|NCT00002048|Drug|Zidovudine|
12082609|NCT00002047|Drug|Zidovudine|
12082610|NCT00002046|Drug|Zidovudine|
12082611|NCT00002045|Drug|Zidovudine|
12082612|NCT00002044|Drug|Zidovudine|
12082613|NCT00002043|Drug|Dapsone|
12082614|NCT00002042|Drug|Epoetin alfa|
12082615|NCT00002041|Drug|Amphotericin B|
12082616|NCT00002040|Drug|Fluconazole|
12082617|NCT00002039|Drug|Foscarnet sodium|
12082618|NCT00002038|Drug|Fluconazole|
12082619|NCT00002037|Drug|Trifluridine|
12082620|NCT00002036|Drug|Anti-HIV Immune Serum Globulin (Human)|
12082621|NCT00002035|Drug|Zidovudine|
12082622|NCT00002035|Drug|Didanosine|
12082623|NCT00002034|Drug|Zidovudine|
12082624|NCT00002034|Drug|Ganciclovir|
12082625|NCT00002033|Drug|Zidovudine|
12082626|NCT00002033|Drug|AS-101|
12082627|NCT00002032|Drug|Rifabutin|
12082628|NCT00002031|Drug|Dinitrochlorobenzene|
12082629|NCT00002030|Drug|Pentamidine isethionate|
12082630|NCT00002029|Drug|Fat Emulsion 2%|
12082631|NCT00002029|Drug|Fat Emulsion 20%|
12082632|NCT00002028|Drug|Didanosine|
12082633|NCT00002027|Drug|Diclazuril|
12082634|NCT00002026|Drug|Acyclovir|
12082635|NCT00002025|Drug|Ganciclovir|
12082636|NCT00002024|Drug|Ganciclovir|
12082637|NCT00002023|Drug|Zidovudine|
12082638|NCT00002022|Drug|Epoetin alfa|
12082639|NCT00002021|Drug|Foscarnet sodium|
12082640|NCT00002020|Drug|Zidovudine|
12082641|NCT00002019|Drug|Amphotericin B, Lipid-based|
12082642|NCT00002019|Drug|Amphotericin B|
12082643|NCT00002018|Drug|Interferon alfa-n3|
12082644|NCT00002017|Drug|Interleukin-2, Polyethylene Glycolated|
12082645|NCT00002016|Drug|Sevirumab|
12082646|NCT00002015|Drug|Ganciclovir|
12082647|NCT00002014|Drug|Zidovudine|
12082662|NCT00002003|Drug|Mitoxantrone hydrochloride|
12082663|NCT00002003|Drug|Etoposide|
12082664|NCT00002002|Drug|Trimethoprim|
12082665|NCT00002002|Drug|Sulfamethoxazole|
12082666|NCT00002002|Drug|Leucovorin calcium|
12082667|NCT00002001|Drug|Zidovudine|
12082668|NCT00002001|Drug|Zalcitabine|
12082669|NCT00002001|Drug|Didanosine|
12082670|NCT00002000|Drug|Valacyclovir hydrochloride|
12082671|NCT00002000|Drug|Acyclovir|
12082672|NCT00001999|Drug|Globulin, Immune|
12082673|NCT00001999|Drug|Ganciclovir|
12082674|NCT00001998|Drug|Nystatin|
12082675|NCT00001997|Drug|Interleukin-2, Polyethylene Glycolated|
12082676|NCT00001997|Drug|Zidovudine|
12082677|NCT00001997|Drug|Didanosine|
12082678|NCT00001996|Drug|Atovaquone|
12082679|NCT00001996|Drug|Pentamidine isethionate|
12082680|NCT00001995|Drug|Rifabutin|
12082681|NCT00001994|Drug|Atovaquone|
12082682|NCT00001993|Drug|Butyldeoxynojirimycin|
12082683|NCT00001993|Drug|Zidovudine|
12082684|NCT00001992|Biological|rgp120/HIV-1IIIB|
12082685|NCT00001991|Drug|Atovaquone|
12082686|NCT00001990|Drug|Atovaquone|
12082687|NCT00001989|Drug|Trichosanthin|
12082688|NCT00001989|Drug|Zidovudine|
12082689|NCT00001136|Biological|ALVAC-HIV MN120TMG (vCP205)|
12082690|NCT00001135|Drug|Nevirapine|
12082691|NCT00001133|Drug|Indinavir sulfate|
12082692|NCT00001133|Drug|Ritonavir|
12082693|NCT00001132|Drug|Abacavir sulfate|
12082694|NCT00001131|Drug|Aldesleukin|Subcutaneous injection of IL-2 in the amount of 2.0 X 10^6 mIU per day for the entire duration of therapy
12082695|NCT00001131|Drug|HAART|Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met
12082696|NCT00001129|Device|Electronic Medication Reminder System|
12082697|NCT00001129|Behavioral|Medication Manager|
12082698|NCT00001128|Drug|Interleukin-12|
12082699|NCT00001128|Drug|Paromomycin sulfate|
12082700|NCT00001128|Drug|Azithromycin|
12082701|NCT00001127|Biological|Influenza virus vaccine (CAIV-T)|
12082702|NCT00001126|Drug|Cidofovir|
12082703|NCT00001125|Biological|Varicella Virus Vaccine (Live)|
12082704|NCT00001123|Drug|Ribavirin|
12082705|NCT00001122|Drug|Nelfinavir mesylate|
12082706|NCT00001122|Drug|Efavirenz|
12082707|NCT00001122|Drug|Stavudine|
12082708|NCT00001122|Drug|Didanosine|
12082709|NCT00001119|Biological|Tetanus Toxoid Vaccine|
12082710|NCT00001119|Drug|Indinavir sulfate|
12082711|NCT00001119|Drug|Lamivudine/Zidovudine|
12082712|NCT00001119|Drug|Ritonavir|
12082713|NCT00001119|Drug|Abacavir sulfate|
12082714|NCT00001119|Drug|Amprenavir|
12082715|NCT00001119|Drug|Efavirenz|
12082716|NCT00001119|Biological|Hepatitis B Vaccine (Recombinant)|
12082717|NCT00001119|Drug|Lamivudine|
12082718|NCT00001119|Drug|Zidovudine|
12082719|NCT00001118|Drug|Enfuvirtide|
12082720|NCT00001116|Drug|Tumor Necrosis Factor soluble receptor-immunoadhesin complex|
12082721|NCT00001115|Drug|Acyclovir|
12082722|NCT00001114|Drug|Interferon alfa-2b|
12082723|NCT00001114|Drug|Didanosine|
12082724|NCT00001113|Drug|Interferon alfa-2a|
12082725|NCT00001113|Drug|Zidovudine|
12082726|NCT00001113|Drug|Interferon alfa-n1|
12082727|NCT00001112|Drug|Zidovudine|
12082728|NCT00001112|Drug|Interferon gamma-1b|
12082729|NCT00001111|Drug|Nevirapine|
12082730|NCT00001111|Drug|Zidovudine|
12082731|NCT00001110|Procedure|Bronchoalveolar lavage|
12082732|NCT00001108|Drug|Ritonavir|
12082733|NCT00001108|Drug|Nelfinavir mesylate|
12082734|NCT00001108|Drug|Saquinavir|
12082735|NCT00001108|Drug|Nevirapine|
12082736|NCT00001108|Drug|Lamivudine|
12082737|NCT00001108|Drug|Stavudine|
12082738|NCT00001108|Drug|Didanosine|
12082739|NCT00001107|Drug|Fluconazole|
12082740|NCT00001107|Drug|AmBisome|
12082741|NCT00001106|Drug|Zidovudine|
12082742|NCT00001105|Drug|F105 Monoclonal Antibody (Human)|
12082743|NCT00001104|Drug|Zidovudine|
12082744|NCT00001101|Drug|ceftriaxone|
12082745|NCT00001101|Drug|doxycycline|
12082746|NCT00001100|Drug|ganciclovir|
12082747|NCT00001096|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
12082748|NCT00001096|Biological|QS-21|
12082749|NCT00001096|Biological|rgp120/HIV-1MN|
12082750|NCT00001095|Drug|Indinavir sulfate|
12082751|NCT00001095|Drug|Amprenavir|
12082752|NCT00001095|Drug|Nevirapine|
12082753|NCT00001095|Drug|Lamivudine|
12082754|NCT00001095|Drug|Stavudine|
12082755|NCT00001095|Drug|Zidovudine|
12082756|NCT00001094|Drug|Lamivudine/Zidovudine|
12082757|NCT00001094|Drug|Nelfinavir mesylate|
12082758|NCT00001094|Drug|Saquinavir|
12082759|NCT00001094|Drug|Delavirdine mesylate|
12082760|NCT00001091|Drug|Ritonavir|
12082761|NCT00001091|Drug|Nelfinavir mesylate|
12082762|NCT00001091|Drug|Nevirapine|
12082763|NCT00001091|Drug|Lamivudine|
12082764|NCT00001091|Drug|Stavudine|
12082765|NCT00001090|Biological|APL 400-047|
12082766|NCT00001090|Biological|ALVAC-HIV MN120TMG (vCP205)|
12082767|NCT00001090|Drug|Sargramostim|
12082768|NCT00001088|Biological|APL 400-047|
12082769|NCT00001088|Drug|Bupivacaine hydrochloride|
12082770|NCT00001087|Drug|Ritonavir|
12082771|NCT00001087|Drug|Nelfinavir mesylate|
12082772|NCT00001087|Drug|Efavirenz|
12082773|NCT00001087|Drug|Levocarnitine|
12082774|NCT00001087|Drug|Adefovir dipivoxil|
12082775|NCT00001087|Drug|Saquinavir|
12082776|NCT00001087|Drug|Lamivudine|
12082777|NCT00001087|Drug|Stavudine|
12082778|NCT00001087|Drug|Zidovudine|
12082797|NCT00001082|Drug|Levocarnitine|500 mg tablet taken orally daily
12082798|NCT00001082|Drug|Adefovir dipivoxil|120 mg tablet taken orally daily
12082799|NCT00001082|Drug|Adefovir dipivoxil placebo|Oral placebo tablet taken daily
12082800|NCT00001081|Drug|Nitazoxanide|
12082801|NCT00001080|Biological|Influenza Virus Vaccine|
12082802|NCT00001080|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
12082803|NCT00001080|Drug|Lamivudine|
12082804|NCT00001079|Drug|Testosterone enanthate|
12082805|NCT00001079|Drug|Megestrol acetate|
12082806|NCT00001078|Biological|Hepatitis A Vaccine (Inactivated)|
12082807|NCT00001077|Dietary Supplement|Multivitamin and mineral supplements|Oral tablets taken daily
12082808|NCT00001077|Dietary Supplement|Peptamen|Solution received daily
12082809|NCT00001077|Dietary Supplement|NuBasics|Solution or dietary bar received daily
12082810|NCT00001076|Biological|ALVAC-HIV MN120TMG (vCP205)|
12082811|NCT00001076|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12082812|NCT00001076|Biological|rgp120/HIV-1 SF-2|
12082813|NCT00001075|Drug|Ritonavir|
12082814|NCT00001075|Drug|Lamivudine|
12082815|NCT00001075|Drug|Zidovudine|
12082816|NCT00001074|Drug|Hydroxyurea|
12082817|NCT00001074|Drug|Didanosine|
12082818|NCT00001073|Drug|Isotretinoin|
12082819|NCT00001072|Biological|ALVAC-HIV MN120TMGNP (vCP300)|
12082820|NCT00001072|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12082821|NCT00001072|Biological|rgp120/HIV-1 SF-2|
12082822|NCT00001071|Drug|Filgrastim|
12082823|NCT00001070|Drug|Oral Vitamin C|
12082824|NCT00001068|Drug|Lamivudine|
12082825|NCT00001067|Drug|Lamivudine|
12082826|NCT00001067|Drug|Stavudine|
12082827|NCT00001067|Drug|Zidovudine|
12082828|NCT00001066|Drug|Lamivudine|
12082829|NCT00001066|Drug|Zidovudine|
12082830|NCT00001066|Drug|Didanosine|
12082831|NCT00001065|Drug|Amphotericin B|
12082832|NCT00001064|Drug|Allogenic Dendritic Cells|
12082833|NCT00001063|Drug|Stavudine|
12082834|NCT00001063|Drug|Zidovudine|
12082835|NCT00001063|Drug|Didanosine|
12082836|NCT00001062|Drug|Ganciclovir|
12082837|NCT00001061|Drug|Sevirumab|
12082838|NCT00001061|Drug|Foscarnet sodium|
12082839|NCT00001061|Drug|Ganciclovir|
12082840|NCT00001060|Biological|HIV-1 C4-V3 Polyvalent Peptide Vaccine|
12082841|NCT00001059|Drug|Doxorubicin hydrochloride (liposomal)|
12082842|NCT00001059|Drug|Filgrastim|
12082843|NCT00001059|Drug|Bleomycin sulfate|
12082844|NCT00001059|Drug|Vincristine sulfate|
12082845|NCT00001058|Drug|Indinavir sulfate|
12082846|NCT00001058|Drug|Ritonavir|
12082847|NCT00001058|Drug|Ethambutol hydrochloride|
12082848|NCT00001058|Drug|Clarithromycin|
12082849|NCT00001058|Drug|Rifabutin|
12082850|NCT00001057|Drug|Zidovudine|
12082851|NCT00001057|Drug|Didanosine|
12082852|NCT00001056|Biological|gp160 Vaccine (Immuno-AG)|
12082853|NCT00001055|Biological|ALVAC-HIV MN120TMG (vCP205)|
12082854|NCT00001055|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12082855|NCT00001055|Biological|rgp120/HIV-1 SF-2|
12082856|NCT00001054|Drug|Valacyclovir hydrochloride|
12082857|NCT00001053|Biological|HIV p17/p24:Ty-VLP|
12082858|NCT00001053|Biological|Aluminum hydroxide|
12082859|NCT00001052|Biological|Aluminum hydroxide|
12082860|NCT00001052|Biological|QS-21|
12082861|NCT00001052|Biological|rgp120/HIV-1MN|
12082862|NCT00001049|Drug|Zidovudine|
12082863|NCT00001049|Drug|Didanosine|
12082864|NCT00001048|Drug|Filgrastim|
12082865|NCT00001048|Drug|Cytarabine|
12082866|NCT00001048|Drug|Zidovudine|
12082867|NCT00001048|Drug|Zalcitabine|
12082868|NCT00001048|Drug|Didanosine|
12082869|NCT00001047|Drug|Ethambutol hydrochloride|
12082870|NCT00001047|Drug|Clarithromycin|
12082871|NCT00001047|Drug|Clofazimine|
12082872|NCT00001047|Drug|Rifabutin|
12082873|NCT00001046|Biological|MF59|
12082874|NCT00001046|Biological|rgp120/HIV-1 SF-2|
12082875|NCT00001045|Drug|Nevirapine|
12082876|NCT00001045|Drug|Zidovudine|
12082877|NCT00001045|Drug|Didanosine|
12082878|NCT00001044|Biological|Aluminum hydroxide|
12082879|NCT00001044|Biological|QS-21|
12082880|NCT00001044|Biological|rgp120/HIV-1MN|
12082881|NCT00001043|Biological|gp160 Vaccine (Immuno-AG)|
12082882|NCT00001042|Biological|Aluminum hydroxide|
12082883|NCT00001042|Biological|Lipid A, Monophosphoryl|
12082884|NCT00001042|Biological|Lipid A, Liposome-encapsulated monophosphoryl|
12082885|NCT00001042|Biological|Syntex adjuvant formulation|
12082886|NCT00001042|Biological|MF59|
12082887|NCT00001042|Biological|Threonyl Muramyl Dipeptide|
12082888|NCT00001042|Biological|rgp120/HIV-1 SF-2|
12082889|NCT00001042|Biological|MTP-PE/MF59|
12082890|NCT00001041|Biological|rgp120/HIV-1MN|
12082891|NCT00001040|Drug|Saquinavir|
12082892|NCT00001040|Drug|Zidovudine|
12082893|NCT00001040|Drug|Zalcitabine|
12082894|NCT00001039|Drug|Ethambutol hydrochloride|
12082895|NCT00001039|Drug|Clarithromycin|
12082896|NCT00001038|Drug|Valacyclovir hydrochloride|
12082897|NCT00001038|Drug|Acyclovir|
12082898|NCT00001037|Biological|gp160 Vaccine (Immuno-AG)|
12082899|NCT00001036|Drug|Thymalfasin|
12082900|NCT00001036|Drug|Interleukin-2, Polyethylene Glycolated|
12082901|NCT00001036|Drug|Zidovudine|
12082902|NCT00001035|Drug|Interferon alfa-2b|
12082903|NCT00001035|Drug|Zidovudine|
12082904|NCT00001035|Drug|Zalcitabine|
12082905|NCT00001035|Drug|Didanosine|
12082906|NCT00001034|Drug|Ganciclovir|
12082907|NCT00001033|Drug|Ethambutol hydrochloride|
12082908|NCT00001033|Drug|Isoniazid|
12082910|NCT00001033|Drug|Pyridoxine hydrochloride|
12082911|NCT00001033|Drug|Levofloxacin|
12082912|NCT00001033|Drug|Rifampin|
12082913|NCT00001032|Drug|Zidovudine|
12082914|NCT00001032|Drug|Zalcitabine|
12082915|NCT00001031|Biological|rgp120/HIV-1MN|
12082916|NCT00001031|Biological|rgp120/HIV-1 SF-2|
12082917|NCT00001030|Drug|Clarithromycin|
12082918|NCT00001030|Drug|Rifabutin|
12082919|NCT00001029|Drug|Zidovudine|
12082920|NCT00001029|Drug|Zalcitabine|
12082921|NCT00001029|Drug|Didanosine|
12082922|NCT00001028|Drug|Pentamidine isethionate|
12082923|NCT00001028|Drug|Dapsone|
12082924|NCT00001027|Drug|Pentamidine isethionate|
12082925|NCT00001026|Biological|gp160 Vaccine (Immuno-AG)|
12082926|NCT00001026|Biological|rgp120/HIV-1IIIB|
12082927|NCT00001026|Biological|rgp120/HIV-1MN|
12082928|NCT00001026|Biological|rgp120/HIV-1 SF-2|
12082929|NCT00001026|Biological|HIVAC-1e|
12082930|NCT00001025|Drug|Zidovudine|
12082931|NCT00001025|Drug|Didanosine|
12082932|NCT00001024|Drug|Zidovudine|
12082933|NCT00001024|Drug|Didanosine|
12082934|NCT00001023|Drug|Clarithromycin|
12082935|NCT00001023|Drug|Azithromycin|
12082936|NCT00001023|Drug|Rifabutin|
12082937|NCT00001022|Drug|Zidovudine|
12082938|NCT00001022|Drug|Zalcitabine|
12082939|NCT00001022|Drug|Didanosine|
12082940|NCT00001021|Biological|rgp120/HIV-1IIIB|
12082941|NCT00001021|Biological|rgp120/HIV-1MN|
12082942|NCT00001020|Biological|rgp120/HIV-1IIIB|
12082943|NCT00001020|Biological|rgp120/HIV-1MN|
12082944|NCT00001019|Biological|rgp120/HIV-1 SF-2|
12082945|NCT00001019|Biological|MTP-PE/MF59|
12082946|NCT00001018|Drug|Letrazuril|
12082947|NCT00001017|Drug|Fluconazole|
12082948|NCT00001017|Drug|Amphotericin B|
12082949|NCT00001016|Drug|Trimetrexate glucuronate|
12082950|NCT00001016|Drug|Leucovorin calcium|
12082951|NCT00001015|Drug|Ribavirin|
12082952|NCT00001014|Drug|Trimetrexate glucuronate|
12082953|NCT00001014|Drug|Sulfamethoxazole-Trimethoprim|
12082954|NCT00001014|Drug|Leucovorin calcium|
12082955|NCT00001013|Drug|Trimetrexate glucuronate|
12082956|NCT00001013|Drug|Pentamidine isethionate|
12082957|NCT00001013|Drug|Sulfamethoxazole-Trimethoprim|
12082958|NCT00001013|Drug|Leucovorin calcium|
12082959|NCT00001012|Drug|AL 721|
12082960|NCT00001011|Drug|Zidovudine|
12082961|NCT00001010|Drug|Zidovudine|
12082962|NCT00001010|Drug|Acyclovir|
12082963|NCT00001009|Drug|Dextran sulfate|
12082964|NCT00001008|Drug|Methadone hydrochloride|
12082965|NCT00001008|Drug|Zidovudine|
12082966|NCT00001007|Drug|Zidovudine|
12082967|NCT00001006|Drug|AS-101|
12082968|NCT00001005|Drug|Zidovudine|
12082969|NCT00001005|Drug|Aldesleukin|
12082970|NCT00001004|Drug|Tumor Necrosis Factor|
12082971|NCT00001004|Drug|Interferon gamma-1b|
12082972|NCT00001003|Drug|Pentamidine isethionate|
12082973|NCT00001003|Drug|Zidovudine|
12082974|NCT00001002|Drug|Zidovudine|
12082975|NCT00001002|Drug|Foscarnet sodium|
12082976|NCT00001001|Drug|Zidovudine|
12082977|NCT00001000|Drug|Ampligen|
12082978|NCT00000999|Drug|Zidovudine|
12082979|NCT00000998|Drug|Trimetrexate glucuronate|
12082980|NCT00000998|Drug|Leucovorin calcium|
12082981|NCT00000997|Drug|Zalcitabine|
12082982|NCT00000996|Drug|Doxorubicin hydrochloride|
12082983|NCT00000995|Drug|Zidovudine|
12082984|NCT00000995|Drug|Ganciclovir|
12082985|NCT00000994|Drug|Zidovudine|
12082986|NCT00000993|Drug|Zidovudine|
12082987|NCT00000992|Drug|Itraconazole|
12082988|NCT00000991|Drug|Pentamidine isethionate|
12082989|NCT00000991|Drug|Sulfamethoxazole-Trimethoprim|
12082990|NCT00000991|Drug|Dapsone|
12082991|NCT00000991|Drug|Zidovudine|
12082992|NCT00000990|Drug|Zidovudine|
12082993|NCT00000989|Drug|Zidovudine|
12082994|NCT00000989|Drug|Sargramostim|
12082995|NCT00000989|Drug|Ganciclovir|
12082996|NCT00000988|Drug|Stavudine|
12082997|NCT00000987|Drug|Bleomycin sulfate|
12082998|NCT00000987|Drug|Vincristine sulfate|
12082999|NCT00000987|Drug|Doxorubicin hydrochloride|
12083000|NCT00000987|Drug|Zidovudine|
12083001|NCT00000986|Drug|Zidovudine|
12083002|NCT00000986|Drug|Aldesleukin|
12083003|NCT00000985|Drug|Vidarabine|
12083004|NCT00000985|Drug|Acyclovir|
12083005|NCT00000985|Drug|Foscarnet sodium|
12083006|NCT00000984|Drug|CD4 Antigens|
12083007|NCT00000983|Drug|Zidovudine|
12083008|NCT00000982|Drug|Zidovudine|
12083009|NCT00000982|Drug|Didanosine|
12083010|NCT00000981|Drug|Fiacitabine|
12083011|NCT00000980|Drug|Spiramycin|
12083012|NCT00000979|Drug|Zidovudine|
12083013|NCT00000979|Drug|Didanosine|
12083014|NCT00000978|Drug|Zidovudine|
12083015|NCT00000978|Drug|Zalcitabine|
12083016|NCT00000977|Biological|gp160 Vaccine (MicroGeneSys)|
12083017|NCT00000976|Drug|CD4-IgG|
12083018|NCT00000976|Drug|Zidovudine|
12083019|NCT00000975|Drug|Itraconazole|
12083020|NCT00000974|Drug|Pentamidine isethionate|
12083021|NCT00000973|Drug|Pyrimethamine|
12083022|NCT00000973|Drug|Leucovorin calcium|
12083023|NCT00000973|Drug|Zidovudine|
12083024|NCT00000972|Biological|MTP-PE/MF59|
12083025|NCT00000972|Biological|Env 2-3|
12083026|NCT00000971|Drug|Clarithromycin|
12083027|NCT00000971|Drug|Zidovudine|
12083028|NCT00000971|Drug|Didanosine|
12083029|NCT00000970|Drug|Foscarnet sodium|
12083030|NCT00000970|Drug|Ganciclovir|
12083033|NCT00000968|Biological|gp160 Vaccine (Immuno-AG)|
12083034|NCT00000967|Drug|Interferon alfa-2a|
12083035|NCT00000967|Drug|Zidovudine|
12083036|NCT00000966|Drug|Azithromycin|
12083037|NCT00000966|Drug|Pyrimethamine|
12083038|NCT00000966|Drug|Leucovorin calcium|
12083039|NCT00000965|Drug|Zidovudine|
12083040|NCT00000964|Drug|Ranitidine hydrochloride|
12083041|NCT00000964|Drug|Foscarnet sodium|
12083042|NCT00000963|Drug|Didanosine|
12083043|NCT00000962|Drug|Nevirapine|
12083044|NCT00000961|Drug|Anti-HIV Immune Serum Globulin (Human)|
12083045|NCT00000961|Drug|Zidovudine|
12083046|NCT00000960|Drug|Zidovudine|
12083047|NCT00000959|Drug|Isoniazid|
12083048|NCT00000959|Drug|Pyridoxine hydrochloride|
12083049|NCT00000958|Biological|MTP-PE/MF59|
12083050|NCT00000958|Biological|Env 2-3|
12083051|NCT00000957|Biological|gp160 Vaccine (Immuno-AG)|
12083052|NCT00000956|Biological|gp160 Vaccine (MicroGeneSys)|
12083053|NCT00000955|Drug|Tuberculin Purified Protein Derivative|Administered intradermally at 5 TU per 0.1 mL
12083054|NCT00000954|Drug|Bleomycin sulfate|
12083055|NCT00000954|Drug|Vincristine sulfate|
12083056|NCT00000954|Drug|Doxorubicin hydrochloride|
12083057|NCT00000954|Drug|Zalcitabine|
12083058|NCT00000954|Drug|Didanosine|
12083059|NCT00000953|Drug|Sorivudine|
12083060|NCT00000953|Drug|Acyclovir|
12083061|NCT00000952|Drug|Ritonavir|
12083062|NCT00000952|Drug|Lamivudine|
12083063|NCT00000952|Drug|Zidovudine|
12083064|NCT00000951|Drug|Fluconazole|
12083065|NCT00000950|Drug|Ethambutol hydrochloride|
12083066|NCT00000950|Drug|Isoniazid|
12083067|NCT00000950|Drug|Pyrazinamide|
12083068|NCT00000950|Drug|Pyridoxine hydrochloride|
12083069|NCT00000950|Drug|Rifampin|
12083070|NCT00000949|Drug|Aldesleukin|
12083071|NCT00000948|Drug|Aldesleukin|Il-2
12083072|NCT00000948|Drug|ART|antiretroviral therapy for the treatment of HIV
12083073|NCT00000947|Drug|Azithromycin|
12083074|NCT00000946|Biological|HIV p24/MF59 Vaccine|
12083075|NCT00000946|Biological|ALVAC-HIV MN120TMG (vCP205)|
12083076|NCT00000946|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12083077|NCT00000946|Biological|rgp120/HIV-1 SF-2|
12083078|NCT00000945|Drug|Cidofovir|
12083079|NCT00000945|Drug|Probenecid|
12083080|NCT00000944|Drug|Indinavir sulfate|
12083081|NCT00000944|Drug|Lamivudine|
12083082|NCT00000944|Drug|Zidovudine|
12083083|NCT00000943|Biological|Tetanus Toxoid Vaccine|
12083084|NCT00000943|Biological|Hepatitis A Vaccine (Inactivated)|
12083085|NCT00000943|Biological|HIV-1 Immunogen|
12083086|NCT00000943|Biological|Hepatitis B Vaccine (Recombinant)|
12083087|NCT00000942|Drug|Nevirapine|
12083088|NCT00000941|Drug|Pravastatin sodium|
12083089|NCT00000941|Drug|Simvastatin|
12083090|NCT00000941|Drug|Atorvastatin calcium|
12083091|NCT00000941|Drug|Ritonavir|
12083092|NCT00000941|Drug|Nelfinavir mesylate|
12083093|NCT00000941|Drug|Saquinavir|
12083094|NCT00000940|Drug|Ritonavir|
12083095|NCT00000940|Drug|Abacavir sulfate|
12083096|NCT00000940|Drug|Amprenavir|
12083097|NCT00000940|Drug|Lamivudine|
12083098|NCT00000940|Drug|Stavudine|
12083099|NCT00000939|Drug|Hydroxyurea|
12083100|NCT00000939|Drug|Efavirenz|
12083101|NCT00000939|Drug|Stavudine|
12083102|NCT00000939|Drug|Didanosine|
12083103|NCT00000938|Drug|ceftriaxone|
12083104|NCT00000938|Drug|doxycycline|
12083105|NCT00000937|Drug|Antibiotics|
12083106|NCT00000936|Drug|hOKT3|Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days.
12083107|NCT00000936|Drug|Oral Cyclosporine|Administered orally as either sandimmune or neoral at a dose determined by weight. Patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day, for the duration of the study.
12083108|NCT00000936|Drug|IV Cyclosporine|Administered intravenously (IV) both during and after transplantation at a dosage determined by individual age.
12083109|NCT00000935|Biological|Intravenous immune globulin (IVIG)|given at a dose of 20mL/kg Intravenous Immune Globulin (Human) (IVIG 10% solvent/detergent)
12083110|NCT00000931|Behavioral|Behavioral intervention|
12083111|NCT00000931|Behavioral|Risk-reduction counseling|
12083112|NCT00000929|Drug|Nonoxynol-9|
12083113|NCT00000928|Behavioral|Group counseling intervention|Participants will engage in a multi-session group-based condom promotion program for approximately 12 months
12083114|NCT00000927|Drug|BufferGel|
12083115|NCT00000926|Drug|Nonoxynol-9|
12083116|NCT00000925|Drug|Optimune oral nutritional supplement|
12083117|NCT00000924|Drug|Ritonavir|
12083118|NCT00000924|Drug|Nelfinavir mesylate|
12083119|NCT00000924|Drug|Nevirapine|
12083120|NCT00000924|Drug|Stavudine|
12083121|NCT00000924|Drug|Didanosine|
12083122|NCT00000923|Drug|Indinavir sulfate|
12083123|NCT00000923|Drug|Lamivudine|
12083124|NCT00000923|Drug|Stavudine|
12083125|NCT00000923|Drug|Zidovudine|
12083126|NCT00000923|Drug|Didanosine|
12083127|NCT00000923|Drug|Aldesleukin|
12083128|NCT00000922|Drug|Indinavir sulfate|
12083129|NCT00000922|Drug|Abacavir sulfate|
12083130|NCT00000922|Drug|Nelfinavir mesylate|
12083131|NCT00000922|Drug|Efavirenz|
12083132|NCT00000922|Drug|Nevirapine|
12083133|NCT00000922|Drug|Lamivudine|
12083134|NCT00000922|Drug|Stavudine|
12083135|NCT00000922|Drug|Didanosine|
12083136|NCT00000921|Drug|Prednisone|
12083137|NCT00000920|Drug|Ritonavir|
12083138|NCT00000920|Drug|Saquinavir|
12083139|NCT00000920|Drug|Lamivudine|
12083140|NCT00000920|Drug|Zidovudine|
12083142|NCT00000919|Drug|Lamivudine/Zidovudine|
12083143|NCT00000919|Drug|Ritonavir|
12083144|NCT00000919|Drug|Hydroxyurea|
12083145|NCT00000919|Drug|Abacavir sulfate|
12083146|NCT00000919|Drug|Amprenavir|
12083147|NCT00000919|Drug|Nelfinavir mesylate|
12083148|NCT00000919|Drug|Efavirenz|
12083149|NCT00000919|Drug|Lamivudine|
12083150|NCT00000919|Drug|Stavudine|
12083151|NCT00000919|Drug|Zidovudine|
12083152|NCT00000919|Drug|Didanosine|
12083153|NCT00000918|Drug|Indinavir sulfate|
12083154|NCT00000918|Drug|Lamivudine/Zidovudine|
12083155|NCT00000918|Drug|Ritonavir|
12083156|NCT00000918|Drug|Amprenavir|
12083157|NCT00000918|Drug|Efavirenz|
12083158|NCT00000918|Drug|Saquinavir|
12083159|NCT00000918|Drug|Lamivudine|
12083160|NCT00000918|Drug|Stavudine|
12083161|NCT00000918|Drug|Zidovudine|
12083162|NCT00000918|Drug|Didanosine|
12083163|NCT00000916|Drug|Indinavir sulfate|
12083164|NCT00000916|Drug|Lamivudine/Zidovudine|
12083165|NCT00000916|Drug|Hydroxyurea|
12083166|NCT00000916|Drug|Lamivudine|
12083167|NCT00000916|Drug|Stavudine|
12083168|NCT00000916|Drug|Zidovudine|
12083169|NCT00000916|Drug|Didanosine|
12083170|NCT00000915|Behavioral|Vaccine preparedness|
12083171|NCT00000914|Drug|Indinavir sulfate|
12083172|NCT00000914|Drug|Ritonavir|
12083173|NCT00000914|Drug|Nelfinavir mesylate|
12083174|NCT00000914|Drug|Efavirenz|
12083175|NCT00000913|Drug|Ritonavir|
12083176|NCT00000913|Drug|Nelfinavir mesylate|
12083177|NCT00000913|Drug|Saquinavir|
12083178|NCT00000912|Drug|Indinavir sulfate|
12083179|NCT00000912|Drug|Abacavir sulfate|
12083180|NCT00000912|Drug|Amprenavir|
12083181|NCT00000912|Drug|Nelfinavir mesylate|
12083182|NCT00000912|Drug|Efavirenz|
12083183|NCT00000912|Drug|Levocarnitine|
12083184|NCT00000912|Drug|Adefovir dipivoxil|
12083185|NCT00000912|Drug|Saquinavir|
12083186|NCT00000909|Drug|Aldesleukin|
12083187|NCT00000906|Drug|Ritonavir|
12083188|NCT00000906|Drug|Saquinavir|
12083189|NCT00000906|Drug|Methadone hydrochloride|
12083190|NCT00000904|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12083191|NCT00000904|Biological|gp160 MN/LAI-2|
12083192|NCT00000904|Biological|ALVAC(1)120(B,MN)GNP (vCP1433)|
12083193|NCT00000904|Biological|ALVAC-HIV MN120TMG (vCP205)|
12083194|NCT00000904|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12083195|NCT00000903|Drug|Indinavir sulfate|
12083196|NCT00000903|Drug|Lamivudine/Zidovudine|
12083197|NCT00000903|Drug|Nelfinavir mesylate|
12083198|NCT00000903|Drug|Efavirenz|
12083199|NCT00000902|Drug|Ritonavir|
12083200|NCT00000902|Drug|Nelfinavir mesylate|
12083201|NCT00000902|Drug|Nevirapine|
12083202|NCT00000902|Drug|Lamivudine|
12083203|NCT00000902|Drug|Stavudine|
12083204|NCT00000902|Drug|Zidovudine|
12083205|NCT00000902|Drug|Zalcitabine|
12083206|NCT00000902|Drug|Didanosine|
12083207|NCT00000901|Drug|Indinavir sulfate|
12083208|NCT00000901|Drug|Lamivudine|
12083209|NCT00000901|Drug|Stavudine|
12083210|NCT00000899|Drug|Nelfinavir mesylate|
12083211|NCT00000899|Drug|Lamivudine|
12083212|NCT00000899|Drug|Filgrastim|
12083213|NCT00000899|Drug|Stavudine|
12083214|NCT00000899|Drug|Cyclophosphamide|
12083215|NCT00000898|Drug|Ritonavir|
12083216|NCT00000898|Drug|Nelfinavir mesylate|
12083217|NCT00000898|Drug|Saquinavir|
12083218|NCT00000897|Drug|Zidovudine|
12083219|NCT00000896|Drug|Indinavir sulfate|
12083220|NCT00000896|Drug|Lamivudine/Zidovudine|
12083221|NCT00000896|Biological|Hepatitis A Vaccine (Inactivated)|
12083222|NCT00000896|Drug|Interleukin-12|
12083223|NCT00000896|Drug|Nevirapine|
12083224|NCT00000896|Drug|Stavudine|
12083225|NCT00000896|Drug|Sargramostim|
12083226|NCT00000895|Drug|Nelfinavir mesylate|
12083227|NCT00000895|Drug|Nevirapine|
12083228|NCT00000895|Drug|Azithromycin|
12083229|NCT00000894|Drug|Cidofovir|
12083230|NCT00000894|Drug|Probenecid|
12083231|NCT00000894|Drug|Ganciclovir|
12083232|NCT00000893|Drug|Nelfinavir mesylate|
12083233|NCT00000893|Drug|Efavirenz|
12083234|NCT00000892|Drug|Ritonavir|
12083235|NCT00000892|Drug|Nelfinavir mesylate|
12083236|NCT00000892|Drug|Levocarnitine|
12083237|NCT00000892|Drug|Adefovir dipivoxil|
12083238|NCT00000892|Drug|Saquinavir|
12083239|NCT00000892|Drug|Delavirdine mesylate|
12083240|NCT00000891|Drug|Ritonavir|
12083241|NCT00000891|Drug|Saquinavir|
12083242|NCT00000891|Drug|Delavirdine mesylate|
12083243|NCT00000891|Drug|Lamivudine|
12083244|NCT00000891|Drug|Stavudine|
12083245|NCT00000891|Drug|Zidovudine|
12083246|NCT00000891|Drug|Didanosine|
12083247|NCT00000889|Drug|Aldesleukin|
12083248|NCT00000888|Drug|Ritonavir|
12083249|NCT00000888|Drug|Lamivudine|
12083250|NCT00000888|Drug|Zidovudine|
12083251|NCT00000887|Drug|Nelfinavir mesylate|
12083252|NCT00000887|Drug|Lamivudine|
12083253|NCT00000887|Drug|Zidovudine|
12083254|NCT00000886|Biological|HIV-1 C4-V3 Polyvalent Peptide Vaccine|
12083255|NCT00000885|Drug|Indinavir sulfate|
12083256|NCT00000885|Drug|Abacavir sulfate|
12083257|NCT00000885|Drug|Nelfinavir mesylate|
12083258|NCT00000885|Drug|Efavirenz|
12083259|NCT00000885|Drug|Levocarnitine|
12083260|NCT00000885|Drug|Adefovir dipivoxil|
12083261|NCT00000885|Drug|Lamivudine|
12083262|NCT00000885|Drug|Stavudine|
12083263|NCT00000885|Drug|Zidovudine|
12083264|NCT00000885|Drug|Didanosine|
12083265|NCT00000884|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|Dosage will vary based on route of administration
12083266|NCT00000884|Biological|ALVAC-HIV MN120TMG (vCP205)|Dosage will vary based on route of administration
12083267|NCT00000884|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|Dosage will vary based on route of administration
12083268|NCT00000883|Drug|Azithromycin|
12083269|NCT00000882|Drug|Indinavir sulfate|
12083270|NCT00000882|Drug|Delavirdine mesylate|
12083271|NCT00000882|Drug|Lamivudine|
12083272|NCT00000882|Drug|Stavudine|
12083273|NCT00000882|Drug|Zidovudine|
12083274|NCT00000881|Drug|Cidofovir|
12083275|NCT00000881|Drug|Probenecid|
12083276|NCT00000880|Drug|Cyclosporine|
12083277|NCT00000879|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
12083278|NCT00000879|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
12083279|NCT00000879|Biological|ALVAC-HIV MN120TMG (vCP205)|
12083280|NCT00000878|Drug|Lamivudine|
12083281|NCT00000878|Drug|Stavudine|
12083282|NCT00000878|Drug|Zidovudine|
12083283|NCT00000877|Drug|Indinavir sulfate|
12083284|NCT00000877|Drug|Rifabutin|
12083285|NCT00000876|Drug|CD4-IgG2|
12083286|NCT00000875|Drug|Indinavir sulfate|
12083287|NCT00000875|Drug|Diphenhydramine hydrochloride|
12083288|NCT00000875|Drug|Lymphocytes, Activated|
12083289|NCT00000875|Drug|Lamivudine|
12083290|NCT00000875|Drug|Zidovudine|
12083291|NCT00000875|Drug|Acetaminophen|
12083292|NCT00000875|Drug|Aldesleukin|
12083293|NCT00000873|Drug|Infant Formula|
12083294|NCT00000872|Drug|Abacavir sulfate|
12083295|NCT00000872|Drug|Nelfinavir mesylate|
12083296|NCT00000872|Drug|Nevirapine|
12083297|NCT00000872|Drug|Lamivudine|
12083298|NCT00000872|Drug|Stavudine|
12083299|NCT00000872|Drug|Zidovudine|
12083300|NCT00000871|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
12083301|NCT00000871|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
12083302|NCT00000871|Biological|ALVAC-HIV MN120TMG (vCP205)|
12083303|NCT00000871|Biological|rgp120/HIV-1 SF-2|
12083304|NCT00000870|Drug|Indinavir sulfate|
12083305|NCT00000870|Drug|Lamivudine|
12083306|NCT00000870|Drug|Stavudine|
12083307|NCT00000870|Drug|Zidovudine|
12083308|NCT00000870|Drug|Didanosine|
12083309|NCT00000870|Drug|Aldesleukin|
12083310|NCT00000869|Drug|Nevirapine|
12083311|NCT00000868|Biological|Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG 203)|
12083312|NCT00000868|Biological|Aluminum hydroxide|
12083313|NCT00000868|Biological|MF59|
12083314|NCT00000868|Biological|rgp120/HIV-1MN|
12083315|NCT00000867|Drug|Memantine|
12083316|NCT00000866|Biological|MN rgp120/HIV-1|
12083317|NCT00000866|Biological|TBC-3B Vaccine|
12083318|NCT00000865|Drug|Abacavir sulfate|
12083319|NCT00000865|Drug|Lamivudine|
12083320|NCT00000865|Drug|Stavudine|
12083321|NCT00000865|Drug|Zidovudine|
12083322|NCT00000865|Drug|Didanosine|
12083323|NCT00000864|Drug|Abacavir sulfate|
12083324|NCT00000864|Drug|Zidovudine|
12083325|NCT00000863|Drug|Sitamaquine|
12083326|NCT00000862|Drug|Zidovudine|
12083327|NCT00000861|Drug|Indinavir sulfate|
12083328|NCT00000859|Drug|Indinavir sulfate|
12083329|NCT00000859|Drug|Ritonavir|
12083330|NCT00000859|Drug|Nelfinavir mesylate|
12083331|NCT00000857|Drug|Interleukin-12|
12083332|NCT00000856|Drug|Foscarnet sodium|
12083333|NCT00000856|Drug|Ganciclovir|
12083334|NCT00000855|Drug|Zidovudine|
12083335|NCT00000854|Drug|Nandrolone decanoate|
12083336|NCT00000853|Biological|rgp120/HIV-1MN|
12083337|NCT00000852|Procedure|Allogeneic lymphocyte transfer|
12083338|NCT00000851|Drug|Stavudine|
12083339|NCT00000851|Drug|Didanosine|
12083340|NCT00000850|Drug|Indinavir sulfate|
12083341|NCT00000850|Drug|Sargramostim|
12083342|NCT00000849|Drug|Aldesleukin|
12083343|NCT00000848|Drug|Indinavir sulfate|
12083344|NCT00000848|Drug|Saquinavir|
12083345|NCT00000847|Biological|ALVAC-HIV MN120TMG (vCP205)|
12083346|NCT00000847|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12083347|NCT00000847|Biological|rgp120/HIV-1 SF-2|
12083348|NCT00000846|Biological|HIV-1 Peptide Vaccine, Microparticulate Monovalent|
12083349|NCT00000846|Biological|HIV-1 Peptide Immunogen, Multivalent|
12083350|NCT00000845|Biological|P3C541b Lipopeptide|
12083351|NCT00000844|Drug|Interferon alfa-n3|
12083352|NCT00000844|Drug|Interferon alfa-n1|
12083353|NCT00000843|Drug|Adefovir dipivoxil|
12083354|NCT00000842|Drug|Nerve Growth Factor, Recombinant Human|
12083355|NCT00000841|Drug|Indinavir sulfate|
12083356|NCT00000841|Drug|Lamivudine|
12083357|NCT00000841|Drug|Stavudine|
12083358|NCT00000841|Drug|Zidovudine|
12083359|NCT00000839|Drug|Didanosine|
12083360|NCT00000838|Drug|Lamivudine|
12083361|NCT00000838|Drug|Stavudine|
12083362|NCT00000838|Drug|Zidovudine|
12083363|NCT00000838|Drug|Didanosine|
12083364|NCT00000837|Biological|Varicella Virus Vaccine (Live)|
12083365|NCT00000836|Drug|Sevirumab|
12083366|NCT00000834|Drug|Lamivudine|
12083367|NCT00000834|Drug|Methotrexate|
12083368|NCT00000834|Drug|Zidovudine|
12083369|NCT00000833|Drug|Ribavirin|
12083370|NCT00000833|Drug|Didanosine|
12083371|NCT00000832|Biological|MF59|
12083372|NCT00000832|Biological|rgp120/HIV-1 SF-2|
12083373|NCT00000831|Drug|Lamivudine|
12083374|NCT00000831|Drug|Stavudine|
12083375|NCT00000831|Drug|Zidovudine|
12083376|NCT00000831|Drug|Didanosine|
12083377|NCT00000829|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|Administered as an injection at 24 months of age
12083378|NCT00000829|Biological|Pneumococcal Conjugate Vaccine, Heptavalent|Administered as an injection at 0, 2, 4, and 15 months of age
12083379|NCT00000829|Biological|Placebo|Administered at 0, 2, 4, and 15 months of age
12083380|NCT00000827|Drug|Anti-HIV Immune Serum Globulin (Human)|
12083381|NCT00000826|Drug|Clarithromycin|
12083382|NCT00000826|Drug|Rifabutin|
12083383|NCT00000826|Drug|Sulfamethoxazole-Trimethoprim|
12083384|NCT00000826|Drug|Dapsone|
12083385|NCT00000826|Drug|Fluconazole|
12083386|NCT00000825|Drug|Aldesleukin|
12083387|NCT00000824|Drug|Lymphocytes, Activated|
12083388|NCT00000823|Drug|Zidovudine|
12083389|NCT00000823|Drug|Didanosine|
12083390|NCT00000822|Drug|Ritonavir|
12083391|NCT00000822|Biological|gp160 Vaccine (Immuno-AG)|
12083392|NCT00000822|Drug|Stavudine|
12083393|NCT00000822|Drug|Didanosine|
12083394|NCT00000821|Drug|Aldesleukin|
12083395|NCT00000820|Drug|Aldesleukin|
12083396|NCT00000819|Drug|Prednisone|
12083397|NCT00000818|Drug|Zidovudine|
12083398|NCT00000817|Drug|Amitriptyline hydrochloride|75 mg oral tablet taken daily
12083399|NCT00000817|Drug|Amitriptyline hydrochloride placebo|Oral placebo tablet taken daily
12083400|NCT00000817|Procedure|Point acupuncture|Standardized or alternate acupuncture procedure
12083401|NCT00000816|Drug|Sulfamethoxazole-Trimethoprim|
12083402|NCT00000815|Biological|Attenuvax|Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age
12083403|NCT00000815|Biological|M-M-R-II|Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
12083404|NCT00000814|Drug|Nevirapine|
12083405|NCT00000814|Drug|Zidovudine|
12083406|NCT00000814|Drug|Didanosine|
12083407|NCT00000813|Biological|ALVAC-HIV gp160MN (vCP125)|
12083408|NCT00000813|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
12083409|NCT00000813|Biological|rgp120/HIV-1 SF-2|
12083410|NCT00000812|Drug|Thalidomide|
12083411|NCT00000811|Drug|Azithromycin|
12083412|NCT00000811|Drug|Atovaquone|
12083413|NCT00000811|Drug|Sulfamethoxazole-Trimethoprim|
12083414|NCT00000810|Drug|Delavirdine mesylate|
12083415|NCT00000810|Drug|Zidovudine|
12083416|NCT00000810|Drug|Didanosine|
12083417|NCT00000809|Biological|Aluminum hydroxide|
12083418|NCT00000809|Biological|QS-21|
12083419|NCT00000809|Biological|MN rsgp120/HIV-1|
12083420|NCT00000808|Drug|Nevirapine|
12083421|NCT00000807|Drug|Etoposide|
12083422|NCT00000806|Drug|Telinavir|
12083423|NCT00000805|Drug|Ganciclovir|
12083424|NCT00000804|Drug|Indinavir sulfate|
12083425|NCT00000803|Drug|Delavirdine mesylate|
12083426|NCT00000803|Drug|Zidovudine|
12083427|NCT00000803|Drug|Didanosine|
12083428|NCT00000802|Drug|Atovaquone|
12083429|NCT00000802|Drug|Dapsone|
12083430|NCT00000801|Drug|Filgrastim|
12083431|NCT00000801|Drug|Vincristine sulfate|
12083432|NCT00000801|Drug|Doxorubicin hydrochloride|
12083433|NCT00000801|Drug|Cyclophosphamide|
12083434|NCT00000801|Drug|Cytarabine|
12083435|NCT00000801|Drug|Dexamethasone|
12083436|NCT00000800|Drug|Methadone hydrochloride|
12083437|NCT00000800|Drug|Zidovudine|
12083438|NCT00000799|Drug|Cidofovir|
12083439|NCT00000799|Drug|Probenecid|
12083440|NCT00000798|Biological|HIV-1 Peptide Vaccine, Microparticulate Monovalent|
12083441|NCT00000796|Drug|Cycloserine|
12083442|NCT00000796|Drug|Ethionamide|
12083443|NCT00000796|Drug|Capreomycin sulfate|
12083444|NCT00000796|Drug|Aminosalicylic acid|
12083445|NCT00000796|Drug|Streptomycin sulfate|
12083446|NCT00000796|Drug|Ethambutol hydrochloride|
12083447|NCT00000796|Drug|Amikacin sulfate|
12083448|NCT00000796|Drug|Isoniazid|
12083449|NCT00000796|Drug|Pyrazinamide|
12083450|NCT00000796|Drug|Pyridoxine hydrochloride|
12083451|NCT00000796|Drug|Levofloxacin|
12083452|NCT00000796|Drug|Rifampin|
12083453|NCT00000796|Drug|Clofazimine|
12083454|NCT00000795|Biological|HIV-1 Peptide Immunogen, Multivalent|
12083455|NCT00000794|Drug|Sulfadiazine|
12083456|NCT00000794|Drug|Clarithromycin|
12083457|NCT00000794|Drug|Atovaquone|
12083458|NCT00000794|Drug|Pyrimethamine|
12083459|NCT00000794|Drug|Leucovorin calcium|
12083460|NCT00000793|Drug|Mexiletine hydrochloride|
12083461|NCT00000793|Drug|Benztropine mesylate|
12083462|NCT00000793|Drug|Amitriptyline hydrochloride|
12083463|NCT00000792|Drug|Hypericin|
12083464|NCT00000791|Drug|Glycovir|
12083465|NCT00000791|Drug|Zidovudine|
12083466|NCT00000790|Drug|Thalidomide|
12083467|NCT00000789|Drug|Stavudine|
12083468|NCT00000789|Drug|Zidovudine|
12083469|NCT00000788|Drug|Methadone hydrochloride|
12083470|NCT00000788|Drug|Fluconazole|
12083471|NCT00000787|Behavioral|Pre- and post-test counseling|
12083472|NCT00000782|Biological|gp160 Vaccine (Immuno-AG)|
12083473|NCT00000782|Biological|gp160 Vaccine (MicroGeneSys)|
12083474|NCT00000781|Drug|Nevirapine|
12083475|NCT00000781|Drug|Zidovudine|
12083476|NCT00000781|Drug|Zalcitabine|
12083477|NCT00000781|Drug|Didanosine|
12083478|NCT00000779|Biological|Aluminum hydroxide|
12083479|NCT00000779|Biological|MF59|
12083480|NCT00000779|Biological|rgp120/HIV-1IIIB|
12083481|NCT00000779|Biological|rgp120/HIV-1MN|
12083482|NCT00000779|Biological|rgp120/HIV-1 SF-2|
12083483|NCT00000779|Biological|Env 2-3|
12083484|NCT00000778|Drug|Isoniazid|
12083485|NCT00000778|Drug|Pyridoxine hydrochloride|
12083486|NCT00000778|Drug|Levofloxacin|
12083487|NCT00000777|Biological|gp160 Vaccine (MicroGeneSys)|
12083492|NCT00000775|Biological|rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine|
12083493|NCT00000774|Biological|rgp120/HIV-1MN|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
12083494|NCT00000774|Biological|rgp120/HIV-1 SF-2|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
12083495|NCT00000774|Biological|Placebo version of rgp120/HIV-1MN|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
12083496|NCT00000774|Biological|Placebo version of rgp120/HIV-1SF2|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
12083497|NCT00000773|Drug|Atovaquone|
12083498|NCT00000772|Drug|Ribavirin|
12083499|NCT00000772|Drug|Didanosine|
12083500|NCT00000771|Drug|Paromomycin sulfate|
12083501|NCT00000770|Drug|Nevirapine|
12083502|NCT00000770|Drug|Zidovudine|
12083503|NCT00000770|Drug|Didanosine|
12083504|NCT00000769|Drug|Interleukin-4|
12083505|NCT00000768|Drug|Glutamic acid hydrochloride|
12083506|NCT00000768|Drug|Ganciclovir|
12083507|NCT00000767|Biological|TBC-3B Vaccine|
12083508|NCT00000767|Biological|Smallpox Vaccine|
12083509|NCT00000766|Drug|Foscarnet sodium|
12083510|NCT00000766|Drug|Ganciclovir|
12083511|NCT00000765|Drug|Zidovudine|
12083512|NCT00000764|Drug|Isotretinoin|
12083513|NCT00000764|Drug|Interferon alfa-2a|
12083514|NCT00000763|Drug|TNP-470|
12083515|NCT00000762|Biological|rgp120/HIV-1MN|
12083516|NCT00000762|Biological|rgp120/HIV-1 SF-2|
12083517|NCT00000762|Biological|gp160 Vaccine (MicroGeneSys)|
12083518|NCT00000761|Drug|Interferon gamma-1b|
12083519|NCT00000760|Drug|Ro 24-7429|
12083520|NCT00000760|Drug|Zidovudine|
12083521|NCT00000760|Drug|Didanosine|
12083522|NCT00000758|Drug|Fluorouracil|
12083523|NCT00000757|Biological|gp160 Vaccine (MicroGeneSys)|
12083524|NCT00000756|Drug|Lymphocytes, Activated|
12083525|NCT00000755|Biological|rgp120/HIV-1MN|
12083526|NCT00000755|Drug|Zidovudine|
12083527|NCT00000754|Drug|Interferon alfa-2a|
12083528|NCT00000754|Drug|Zidovudine|
12083529|NCT00000754|Drug|Zalcitabine|
12083530|NCT00000753|Drug|Atevirdine mesylate|
12083531|NCT00000753|Drug|Zidovudine|
12083532|NCT00000753|Drug|Zalcitabine|
12083533|NCT00000753|Drug|Didanosine|
12083534|NCT00000752|Drug|Pseudoephedrine hydrochloride|
12083535|NCT00000752|Drug|Guaifenesin|
12083536|NCT00000752|Drug|Cefuroxime axetil|
12083537|NCT00000752|Drug|Beclomethasone dipropionate|
12083538|NCT00000751|Drug|Anti-HIV Immune Serum Globulin (Human)|
12083539|NCT00000751|Drug|Globulin, Immune|
12083540|NCT00000751|Drug|Zidovudine|
12083541|NCT00000750|Drug|Zidovudine|
12083542|NCT00000749|Biological|rgp120/HIV-1 SF-2|
12083543|NCT00000748|Drug|Sulfamethoxazole-Trimethoprim|
12083544|NCT00000747|Drug|Nevirapine|
12083545|NCT00000746|Biological|rgp120/HIV-1 SF-2|
12083546|NCT00000746|Biological|Env 2-3|
12083547|NCT00000746|Biological|HIVAC-1e|
12083548|NCT00000746|Biological|gp160 Vaccine (MicroGeneSys)|
12083549|NCT00000745|Biological|Hepatitis B Vaccine (Recombinant)|
12083550|NCT00000745|Biological|gp160 Vaccine (MicroGeneSys)|
12083551|NCT00000744|Drug|Fluconazole|
12083552|NCT00000743|Drug|Alvircept sudotox|
12083553|NCT00000743|Drug|Zidovudine|
12083554|NCT00000742|Drug|Atevirdine mesylate|
12083555|NCT00000742|Drug|Zidovudine|
12083556|NCT00000742|Drug|Didanosine|
12083557|NCT00000741|Drug|Methylprednisolone|
12083558|NCT00000740|Drug|Sitamaquine|
12083559|NCT00000739|Drug|Dapsone|
12083560|NCT00000738|Drug|Nimodipine|
12083561|NCT00000738|Drug|Zidovudine|
12083562|NCT00000737|Drug|Dronabinol|
12083563|NCT00000737|Drug|Megestrol acetate|
12083564|NCT00000736|Drug|Zidovudine|
12083565|NCT00000735|Drug|Ampligen|
12083566|NCT00000734|Drug|Sulfamethoxazole-Trimethoprim|
12083567|NCT00000734|Drug|Zidovudine|
12083568|NCT00000733|Drug|Ribavirin|
12083569|NCT00000732|Drug|Sulfamethoxazole-Trimethoprim|
12083570|NCT00000732|Drug|Zidovudine|
12083571|NCT00000731|Drug|Zidovudine|
12083572|NCT00000731|Drug|Acetaminophen|
12083573|NCT00000730|Drug|Trimetrexate glucuronate|
12083574|NCT00000730|Drug|Methylprednisolone|
12083575|NCT00000730|Drug|Pentamidine isethionate|
12083576|NCT00000730|Drug|Sulfamethoxazole-Trimethoprim|
12083577|NCT00000730|Drug|Leucovorin calcium|
12083578|NCT00000729|Drug|Foscarnet sodium|
12083579|NCT00000728|Drug|Zidovudine|
12083580|NCT00000728|Drug|Aldesleukin|
12083581|NCT00000727|Drug|Pentamidine isethionate|
12083582|NCT00000727|Drug|Pyrimethamine|
12083583|NCT00000727|Drug|Sulfamethoxazole/Trimethoprim|
12083584|NCT00000727|Drug|Sulfadoxine/Pyrimethamine|
12083585|NCT00000727|Drug|Zidovudine|
12083586|NCT00000726|Drug|Foscarnet sodium|
12083587|NCT00000725|Drug|Interferon alfa-2a|
12083588|NCT00000725|Drug|Zidovudine|
12083589|NCT00000725|Drug|Interferon alfa-n1|
12083590|NCT00000724|Drug|Trimetrexate glucuronate|
12083591|NCT00000724|Drug|Leucovorin calcium|
12083592|NCT00000723|Drug|Methotrexate|
12083593|NCT00000723|Drug|Leucovorin calcium|
12083594|NCT00000723|Drug|Zidovudine|
12083595|NCT00000723|Drug|Dexamethasone|
12083596|NCT00000722|Drug|Pentamidine isethionate|
12083597|NCT00000721|Drug|CD4 Antigens|
12083598|NCT00000720|Drug|Globulin, Immune|
12083599|NCT00000720|Drug|Zidovudine|
12083600|NCT00000719|Drug|Zidovudine|
12083601|NCT00000719|Drug|Zalcitabine|
12083607|NCT00000715|Drug|Pentamidine isethionate|
12083608|NCT00000715|Drug|Sulfamethoxazole-Trimethoprim|
12083609|NCT00000714|Drug|Trimetrexate glucuronate|
12083610|NCT00000714|Drug|Leucovorin calcium|
12083611|NCT00000713|Drug|Ampligen|
12083612|NCT00000712|Drug|Zidovudine|
12083613|NCT00000712|Drug|Acyclovir|
12083614|NCT00000711|Drug|Zidovudine|
12083615|NCT00000711|Drug|Sargramostim|
12083616|NCT00000710|Drug|Didanosine|
12083617|NCT00000709|Drug|Zidovudine|
12083618|NCT00000708|Drug|Flucytosine|
12083619|NCT00000708|Drug|Fluconazole|
12083620|NCT00000708|Drug|Amphotericin B|
12083621|NCT00000707|Drug|Pentamidine isethionate|
12083622|NCT00000706|Drug|Quinine sulfate|
12083623|NCT00000706|Drug|Probenecid|
12083624|NCT00000706|Drug|Zidovudine|
12083625|NCT00000705|Drug|Zidovudine|
12083626|NCT00000704|Drug|Zalcitabine|
12083627|NCT00000703|Drug|Bleomycin sulfate|
12083628|NCT00000703|Drug|Vincristine sulfate|
12083629|NCT00000703|Drug|Doxorubicin hydrochloride|
12083630|NCT00000703|Drug|Cyclophosphamide|
12083631|NCT00000703|Drug|Allopurinol|
12083632|NCT00000703|Drug|Methotrexate|
12083633|NCT00000703|Drug|Cytarabine|
12083634|NCT00000703|Drug|Leucovorin calcium|
12083635|NCT00000703|Drug|Zidovudine|
12083636|NCT00000703|Drug|Dexamethasone|
12083637|NCT00000702|Drug|Zidovudine|
12083638|NCT00000701|Drug|Zidovudine|
12083639|NCT00000700|Drug|Zidovudine|
12083640|NCT00000699|Drug|Inosine pranobex|
12083641|NCT00000699|Drug|Ribavirin|
12083642|NCT00000698|Drug|Ganciclovir|
12083643|NCT00000697|Drug|Foscarnet sodium|
12083644|NCT00000696|Drug|Interferon alfa-2a|
12083645|NCT00000696|Drug|Zidovudine|
12083646|NCT00000695|Drug|Interferon beta-1b|
12083647|NCT00000695|Drug|Zidovudine|
12083648|NCT00000694|Drug|Interferon alfa-2b|
12083649|NCT00000694|Drug|Zidovudine|
12083650|NCT00000694|Drug|Sargramostim|
12083651|NCT00000693|Drug|Zidovudine|
12083652|NCT00000693|Drug|Acyclovir|
12083653|NCT00000692|Drug|Butyldeoxynojirimycin|
12083654|NCT00000691|Drug|Foscarnet sodium|
12083655|NCT00000690|Drug|Dextran sulfate|
12083656|NCT00000689|Drug|Bleomycin sulfate|
12083657|NCT00000689|Drug|Vincristine sulfate|
12083658|NCT00000689|Drug|Doxorubicin hydrochloride|
12083659|NCT00000689|Drug|Cyclophosphamide|
12083660|NCT00000689|Drug|Methotrexate|
12083661|NCT00000689|Drug|Cytarabine|
12083662|NCT00000689|Drug|Leucovorin calcium|
12083663|NCT00000689|Drug|Sargramostim|
12083664|NCT00000689|Drug|Dexamethasone|
12083665|NCT00000688|Drug|Ganciclovir|
12083666|NCT00000687|Drug|Interferon alfa-2a|
12083667|NCT00000687|Drug|Zidovudine|
12083668|NCT00000686|Drug|Stavudine|
12083669|NCT00000685|Drug|Zidovudine|
12083670|NCT00000684|Drug|Dextran sulfate|
12083671|NCT00000683|Biological|HIVAC-1e|
12083672|NCT00000683|Biological|gp160 Vaccine (MicroGeneSys)|
12083673|NCT00000682|Drug|Zidovudine|
12083674|NCT00000682|Drug|Zalcitabine|
12083675|NCT00000681|Drug|Bleomycin sulfate|
12083676|NCT00000681|Drug|Vincristine sulfate|
12083677|NCT00000681|Drug|Doxorubicin hydrochloride|
12083678|NCT00000681|Drug|Zidovudine|
12083679|NCT00000681|Drug|Sargramostim|
12083680|NCT00000680|Drug|Zidovudine|
12083681|NCT00000680|Drug|Aldesleukin|
12083682|NCT00000679|Drug|Zidovudine|
12083683|NCT00000679|Drug|Zalcitabine|
12083684|NCT00000678|Drug|Zidovudine|
12083685|NCT00000678|Drug|Zalcitabine|
12083686|NCT00000677|Drug|SCH 39304|
12083687|NCT00000676|Drug|Clotrimazole|
12083688|NCT00000676|Drug|Fluconazole|
12083689|NCT00000675|Drug|CD4-IgG|
12083690|NCT00000674|Drug|Pyrimethamine|
12083691|NCT00000674|Drug|Leucovorin calcium|
12083692|NCT00000674|Drug|Clindamycin|
12083693|NCT00000673|Drug|Ganciclovir|
12083694|NCT00000672|Drug|Didanosine|
12083695|NCT00000671|Drug|Zidovudine|
12083696|NCT00000671|Drug|Didanosine|
12083697|NCT00000670|Drug|Probenecid|
12083698|NCT00000670|Drug|Zidovudine|
12083699|NCT00000669|Drug|Didanosine|
12083700|NCT00000668|Drug|Ganciclovir|
12083701|NCT00000667|Biological|gp160 Vaccine (MicroGeneSys)|
12083702|NCT00000666|Drug|Pyrimethamine|
12083703|NCT00000665|Drug|Foscarnet sodium|
12083704|NCT00000665|Drug|Ganciclovir|
12083705|NCT00000664|Drug|Interleukin-2, Polyethylene Glycolated|
12083706|NCT00000664|Drug|Zidovudine|
12083707|NCT00000663|Drug|CD4-IgG|
12083708|NCT00000662|Drug|Zidovudine|
12083709|NCT00000661|Drug|Oxazepam|
12083710|NCT00000661|Drug|Zidovudine|
12083711|NCT00000660|Drug|Etoposide|
12083712|NCT00000659|Drug|CD4 Antigens|
12083713|NCT00000659|Drug|Zidovudine|
12083714|NCT00000658|Drug|Bleomycin sulfate|
12083715|NCT00000658|Drug|Vincristine sulfate|
12083716|NCT00000658|Drug|Doxorubicin hydrochloride|
12083717|NCT00000658|Drug|Cyclophosphamide|
12083718|NCT00000658|Drug|Allopurinol|
12083719|NCT00000658|Drug|Methotrexate|
12083720|NCT00000658|Drug|Cytarabine|
12083721|NCT00000658|Drug|Leucovorin calcium|
12083722|NCT00000658|Drug|Sargramostim|
12083723|NCT00000658|Drug|Dexamethasone|
12083724|NCT00000657|Drug|Zidovudine|
12083725|NCT00000657|Drug|Didanosine|
12083726|NCT00000656|Drug|Zidovudine|
12083727|NCT00000656|Drug|Didanosine|
12083728|NCT00000655|Drug|Atovaquone|
12083729|NCT00000655|Drug|Sulfamethoxazole-Trimethoprim|
12083739|NCT00000648|Drug|Penicillin G potassium|
12083740|NCT00000648|Drug|Ceftriaxone sodium|
12083741|NCT00000647|Drug|CD4-IgG|
12083742|NCT00000647|Drug|Zidovudine|
12083743|NCT00000647|Drug|Interferon alfa-n1|
12083744|NCT00000647|Procedure|Peripheral lymphocyte infusion|
12083745|NCT00000647|Procedure|Bone marrow transplant|
12083746|NCT00000646|Drug|Pentoxifylline|
12083747|NCT00000645|Drug|Hypericin|
12083748|NCT00000644|Drug|Clarithromycin|
12083749|NCT00000643|Drug|Pyrimethamine|
12083750|NCT00000643|Drug|Leucovorin calcium|
12083751|NCT00000642|Drug|CD4-IgG|
12083752|NCT00000641|Drug|Ciprofloxacin hydrochloride|
12083753|NCT00000641|Drug|Ethambutol hydrochloride|
12083754|NCT00000641|Drug|Amikacin sulfate|
12083755|NCT00000641|Drug|Azithromycin|
12083756|NCT00000641|Drug|Rifampin|
12083757|NCT00000641|Drug|Clofazimine|
12083758|NCT00000640|Drug|Primaquine|
12083759|NCT00000640|Drug|Sulfamethoxazole-Trimethoprim|
12083760|NCT00000640|Drug|Dapsone|
12083761|NCT00000640|Drug|Clindamycin|
12083762|NCT00000639|Drug|Itraconazole|
12083763|NCT00000639|Drug|Flucytosine|
12083764|NCT00000639|Drug|Fluconazole|
12083765|NCT00000639|Drug|Amphotericin B|
12083766|NCT00000638|Drug|Isoniazid|
12083767|NCT00000638|Drug|Pyrazinamide|
12083768|NCT00000638|Drug|Pyridoxine hydrochloride|
12083769|NCT00000638|Drug|Rifampin|
12083770|NCT00000637|Drug|Zidovudine|
12083771|NCT00000637|Drug|Didanosine|
12083772|NCT00000636|Drug|Isoniazid|
12083773|NCT00000636|Drug|Pyrazinamide|
12083774|NCT00000636|Drug|Pyridoxine hydrochloride|
12083775|NCT00000636|Drug|Rifampin|
12083776|NCT00000635|Drug|Trifluridine|
12083777|NCT00000635|Drug|Bacitracin zinc/Polymyxin B sulfate|
12083778|NCT00000634|Drug|Nevirapine|
12083779|NCT00000633|Biological|gp160 Vaccine (Immuno-AG)|
12083780|NCT00000633|Biological|Hepatitis B Vaccine (Recombinant)|
12083781|NCT00000632|Biological|Env 2-3|
12083782|NCT00000631|Biological|HIVAC-1e|
12083783|NCT00000631|Biological|gp160 Vaccine (MicroGeneSys)|
12083784|NCT00000630|Biological|HIVAC-1e|
12083785|NCT00000630|Biological|gp160 Vaccine (MicroGeneSys)|
12083786|NCT00000629|Drug|Valproic acid|
12083787|NCT00000629|Drug|Zidovudine|
12083788|NCT00000628|Drug|L-697,661|
12083789|NCT00000628|Drug|Zidovudine|
12083790|NCT00000627|Drug|Fluconazole|
12083791|NCT00000626|Drug|Vinblastine sulfate|
12083792|NCT00000626|Drug|Dacarbazine|
12083793|NCT00000626|Drug|Filgrastim|
12083794|NCT00000626|Drug|Bleomycin sulfate|
12083795|NCT00000626|Drug|Doxorubicin hydrochloride|
12083796|NCT00000625|Drug|Zidovudine|
12083797|NCT00000625|Drug|Zalcitabine|
12083798|NCT00000625|Drug|Didanosine|
12083799|NCT00023192|Drug|T-Cell Depleted & CD34+Select/w/StemCell Enriched Product|
12083800|NCT00023166|Drug|PEG-paclitaxel|
12083801|NCT00023153|Drug|Adefovir Dipivoxil|
12083802|NCT00023127|Procedure|Integrated Pest Management|
12083803|NCT00022971|Biological|Apolizumab|Apolizumab IV on Day 1. Administer weekly for 4 weeks
12083804|NCT00022971|Biological|Rituximab|Rituximab IV 24-36 hours after Apolizumab ends. Administer weekly for 4 weeks
12083805|NCT00022958|Drug|Iodine-131 Anti-B1 Antibody|
12083806|NCT00022945|Drug|Iodine-131 Anti-B1 Antibody|
12083807|NCT00022945|Drug|Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP)|
12083808|NCT00022932|Drug|Iodine-131 Anti-B1 Antibody|
12083809|NCT00022906|Drug|Iodine-131 Anti-B1 Antibody|
12083810|NCT00022893|Drug|Iodine-131 Anti-B1 Antibody|
12083811|NCT00022880|Drug|Iodine-131 Anti-B1 Antibody|
12083812|NCT00022867|Drug|Nondigestible oligosaccharide (NDO)|
12083813|NCT00022854|Procedure|Single-injection femoral nerve block|Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
12083814|NCT00022854|Procedure|Femoral nerve block 60-hour continuous injection|Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine
12083815|NCT00022854|Procedure|Saline (control) injection into femoral nerve envelope|Nerve block bolus with 30 mL saline, followed by continuous saline infusion
12083816|NCT00022841|Drug|Pamidronate|
12083817|NCT00022828|Device|3-D Laser Imaging Device|
12083818|NCT00022815|Device|Tissue ultrafiltration|
12083819|NCT00022802|Device|Image-guided surgical system|
12083820|NCT00022776|Procedure|Surgical decompression|Simple decompression not requiring fusion.
12083821|NCT00022776|Procedure|Physical therapy|2 physical therapy sessions per week for 6 weeks Followed by home program.
12083822|NCT00022750|Behavioral|Nurse Case Manager and Community Health Worker Team|
12083823|NCT00021866|Behavioral|Differential Abilities Scale|IQ measurement at 3, 4.5 and 6 years of age
12083824|NCT00021866|Behavioral|Neuropsychological Testing|Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
12083825|NCT00021853|Behavioral|constraint-induced movement therapy|
12083826|NCT00021827|Drug|Parathyroid hormone-related protein or ''PTHrP''|
12083827|NCT00021814|Drug|Doxazosin|
12083828|NCT00021814|Drug|Finasteride|
12083829|NCT00021814|Drug|Doxazosin placebo|
12083830|NCT00021814|Drug|Finasteride placebo|
12083831|NCT00021801|Procedure|Islet Cell Transplantation|
12083832|NCT00021788|Procedure|islet cell transplantation|
12083833|NCT00021749|Drug|Oblimerson sodium, G3139|
12083834|NCT00021736|Drug|EYE001 anti-VEGF aptamer|
12083835|NCT00021723|Biological|AN-1792 also known as AIP-001|
12083836|NCT00021697|Drug|AVP-923|
12083837|NCT00021658|Procedure|Pesticide application procedures|
12083838|NCT00021645|Drug|Vitamin E|
12083839|NCT00021580|Procedure|human cadaveric islet cell transplantation|
12083840|NCT00021567|Drug|Interferon Gamma for Aerosol|
12083841|NCT00021541|Drug|tipifarnib|Given orally, 200 mg/m^2/dose BSA every 12 hours by mouth (po) daily x 21 days, Course is every 28 days
12083842|NCT00021541|Other|placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.
12083843|NCT00021528|Drug|citalopram|
12083844|NCT00021528|Drug|BuproprionSR|
12083845|NCT00021528|Drug|buspirone|
12083846|NCT00021528|Drug|Lithium|
12083847|NCT00021528|Drug|mirtazapine|
12083848|NCT00021528|Drug|nortriptyline|
12083849|NCT00021528|Drug|sertraline|
12083850|NCT00021528|Drug|tranylcypromine|
12083851|NCT00021528|Drug|VenlafaxineXR|
12083852|NCT00021528|Behavioral|Cognitive Therapy|
12083853|NCT00021528|Drug|T3 (Triiodothyronine)|
12083854|NCT00021502|Drug|pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)|
12083855|NCT00021476|Behavioral|Behavioral treatments|
12083856|NCT00021476|Behavioral|Physical therapy|
12083857|NCT00018902|Drug|Fluoxetine|Standard anti-depressant treatment with the SSRI fluoxetine
12083858|NCT00018902|Drug|Venlafaxine|Standard antidepressant treatment with the non-SSRI medication venlafaxine
12083859|NCT00018902|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT addresses maladaptive beliefs in order to encourage behavioral change
12083860|NCT00018902|Drug|Citalopram|Standard anti-depressant treatment with the SSRI fluoxetine
12083861|NCT00018876|Procedure|Lumbar nerve root decompression|
12083862|NCT00018876|Procedure|Preoperative low-dose external beam radiation|
12083863|NCT00018863|Drug|Methylphenidate|
12083864|NCT00018850|Drug|ondansetron|
12083865|NCT00018850|Behavioral|neuropsychological testing|
12083866|NCT00018850|Drug|nicotine|
12083867|NCT00018850|Drug|haloperidol|
12083868|NCT00018837|Behavioral|Community Re-Entry Program: What is Schizophrenia|
12083869|NCT00018824|Drug|NALTREXONE|
12083870|NCT00018824|Drug|Placebo|
12083871|NCT00018811|Behavioral|Relaxation training & thermal biofeedback|
12083872|NCT00018811|Behavioral|Surface EMG biofeedback|
12083873|NCT00018785|Procedure|donor bone marrow infusion|
12083874|NCT00018759|Drug|paroxetine|
12083875|NCT00018759|Behavioral|ongoing psychological screening|
12083876|NCT00018746|Device|repetitive transcranial magnetic stimulation|
12083877|NCT00018733|Drug|paroxetine|
12083878|NCT00018733|Drug|Desipramine|
12083879|NCT00018694|Drug|Chenodeoxycholic Acid|
12083880|NCT00018668|Drug|Risperidone|
12083881|NCT00018668|Drug|Olanzapine|
12083882|NCT00018668|Drug|Quetiapine|
12083883|NCT00018655|Behavioral|Twelve Step Facilitation|Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.
12083884|NCT00018655|Behavioral|Integrated Cognitive Behavioral Treatment|Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.
12083885|NCT00018642|Drug|quetiapine|
12083886|NCT00018642|Drug|haloperidol decanoate|
12083887|NCT00018616|Behavioral|MEMS caps|
12083888|NCT00018603|Drug|guanfacine|
12083889|NCT00018564|Drug|treatments for essential tremor|
12083890|NCT00018551|Drug|Folic Acid|
12083891|NCT00018538|Drug|calcifidiol|
12083892|NCT00018525|Procedure|Lung Volume Reduction Surgery|
12083893|NCT00018512|Procedure|Implant-supported denture|
12083894|NCT00018460|Drug|Vitamin B|
12083895|NCT00018447|Drug|PTH 1-34|
12083896|NCT00018447|Drug|MFPSR-fluoride|
12083897|NCT00018421|Procedure|Treadmill Exercise|
12083898|NCT00018382|Drug|rosiglitazone|
12083899|NCT00018356|Procedure|exercise|
12083900|NCT00018356|Drug|testosterone|
12083901|NCT00018343|Drug|estrogen|
12083902|NCT00018330|Behavioral|Weight Loss|
12083903|NCT00018317|Behavioral|low protein diet|
12083904|NCT00018317|Behavioral|resistance training|
12083905|NCT00018317|Behavioral|combination of diet control and exercise|
12083906|NCT00018291|Drug|Risperidone|
12083907|NCT00018291|Drug|Gabapentin|
12083908|NCT00018278|Drug|Aricept|
12083909|NCT00018278|Drug|Exelon|
12083910|NCT00018278|Drug|Nicoderm Patch|
12083911|NCT00018265|Behavioral|Task specific endurance training|
12083912|NCT00018265|Behavioral|Tai Chi|
12083913|NCT00018252|Behavioral|exercise|
12083914|NCT00018239|Procedure|Exercise|
12083915|NCT00018226|Behavioral|Case Management|
12083916|NCT00018213|Drug|Naltrexone Hydrochloride|
12083917|NCT00018213|Drug|Transdermal Nicotine|
12083918|NCT00018200|Drug|Desipramine|Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)
12083919|NCT00018200|Drug|Fluoxetine|Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)
12083920|NCT00018200|Drug|Benztropine|Daily dose 0.125 to 0.5mg
12083921|NCT00018187|Drug|Bupropion|
12083922|NCT00018187|Drug|Mecamylamine|
12083923|NCT00018187|Drug|Nicotine Patch|
12083924|NCT00018174|Drug|Fluoxetine|
12083925|NCT00018174|Behavioral|Behavioral group smoking cessation treatment|
12083926|NCT00018174|Drug|Placebo|
12083927|NCT00018161|Drug|Mecamylamine|
12083928|NCT00018161|Drug|Nicotine Patch|
12083929|NCT00018161|Behavioral|Cigarette brand switching|
12083930|NCT00018148|Drug|nortriptyline|Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg
12083931|NCT00018148|Drug|transdermal nicotine|Transdermal nicotine 21 mg, titrated down plus placebo
12083932|NCT00018135|Drug|calcium acetate|
12083933|NCT00018135|Drug|aluminum hydroxide|
12083934|NCT00018135|Drug|Sevelamer|
12083935|NCT00018109|Drug|glutamine|
12083936|NCT00018109|Drug|creatine monohydrate|
12083937|NCT00018096|Biological|LPS endotoxin, saline, HDM|instillation of interventional products during bronchoscopy each down a different airway, each subject acts as their own control.
12083938|NCT00018083|Drug|rifabutin|
12083939|NCT00018083|Drug|isoniazid|
12083940|NCT00018083|Drug|efavirenz|
12083941|NCT00018070|Procedure|Angiography|
12083942|NCT00018070|Procedure|Laser Treatment|
12083943|NCT00018057|Behavioral|Attention Bias Modification Training|The intervention is computer-based. The active and control treatments have two components. In one component of the active intervention, subjects are asked to indicate the identity of a letter that appears behind a neutral face, opposite from an angry face. In another component of the active intervention, subjects are asked to identify numbers that are hidden within a puzzle, in locations distal from angry faces. In both components of the active intervention, subjects implicitly learn to shift their attention away from angry faces. This is because the faces are systematically arranged to be far removed from letters and numbers that need to be identified. The control arm of the intervention involves similar components. However, unlike in the intervention arm, angry faces appear in various locations near letters and numbers. Therefore, attention is not shaped in the control arm. This intervention requires five minutes per session and is administered before weekly psychotherapy sessions.
12083944|NCT00018031|Drug|Peginterferon alfa-2b|Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously
12083945|NCT00018031|Drug|Ribavirin|Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.
12083946|NCT00018018|Drug|CD34+ cells transduced with ADA retrovir|
12083947|NCT00018005|Behavioral|Self-Management|18 in-person group sessions providing self-management training.
12083948|NCT00018005|Other|attention control|18 educational mailings follow by a a telephone call.
12083949|NCT00017940|Genetic|Human Nerve Growth Factor|
12083950|NCT00017953|Behavioral|Lifestyle Intervention|The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.
12083951|NCT00017953|Behavioral|Diabetes Support and Education|Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
12083952|NCT00017927|Drug|Pegvisomant|
12083953|NCT00017823|Procedure|Acupressure|
12083954|NCT00017810|Behavioral|Dietary intervention|
12083955|NCT00017706|Behavioral|physician-delivered weight control|
12083956|NCT00016835|Procedure|Supra-gingival scaling and placebo|Included in arm/group description.
12083957|NCT00016835|Procedure|Subgingival scaling and metronidazole|Included in arm/group description.
12083958|NCT00016835|Procedure|Subgingival scaling and doxycycline|Included in arm/group description.
12083959|NCT00017680|Drug|Melphalan|100 mg/m2 twice a day from Days -2 and -1 as induction therapy
12083960|NCT00017680|Procedure|Autologous Stem Cell Transplantation|Bone marrow and peripheral blood stem cells harvested
12083961|NCT00017654|Drug|anti-thymocyte globulin|
12083962|NCT00017654|Drug|cyclophosphamide|
12083963|NCT00017654|Drug|cyclosporine|
12083964|NCT00017654|Drug|methylprednisolone|
12083965|NCT00017654|Procedure|Allogeneic Bone Marrow Transplantation|
12083966|NCT00017641|Drug|anti-thymocyte globulin|
12083967|NCT00017641|Drug|cyclophosphamide|
12083968|NCT00017641|Drug|filgrastim|
12083969|NCT00017641|Procedure|CD34+ Peripheral Blood Stem Cell Reinfusion|
12083970|NCT00017628|Drug|cyclophosphamide|
12083971|NCT00017628|Drug|filgrastim|
12083972|NCT00017628|Drug|methylprednisolone|
12083973|NCT00017628|Procedure|Autologous Stem Cell Transplantation|
12083974|NCT00016744|Drug|Sodium 4-Phenylbutyrate (4PBA)|The standard oral adult dose is 20g/day (tablets) for 4 days.
12083975|NCT00016744|Drug|Unconjugated Isoflavones 100 (PTI G-4660, 87% Genistein)|Every participant will be administered a perfusion of 50 MicroM of Genistein during the modified NPD procedure.
12083976|NCT00016744|Drug|Placebo|The placebo dose will match the oral tablets in arm 1, maintaining the study blind.
12083977|NCT00016679|Drug|1-Octanol|
12083978|NCT00016666|Drug|Propranolol|
12083979|NCT00016653|Drug|Creatine Monohydrate|
12083980|NCT00016653|Drug|Glutamine|
12083981|NCT00016549|Biological|Bevacizumab|
12083982|NCT00016523|Drug|Inhaled nitric oxide|Started at 5 ppm and could be increased to 10 ppm
12083983|NCT00016523|Drug|Placebo|Started at 5 ppm and could be increased to 10 ppm
12083984|NCT00016497|Procedure|bilateral myringotomy|
12083985|NCT00016497|Procedure|bilateral myringotomy and tubes|
12083986|NCT00016497|Procedure|adenoidectomy|
12083987|NCT00016471|Procedure|Audiogram|
12083988|NCT00016471|Procedure|Electroretinogram|
12083989|NCT00016458|Drug|anti-thymocyte globulin|
12083990|NCT00016458|Drug|cyclophosphamide|
12083991|NCT00016445|Drug|growth hormone|
12083992|NCT00015808|Drug|Idebenone|
12083993|NCT00015795|Device|airway interruption test|
12083994|NCT00015769|Drug|levetiracetam|
12083995|NCT00015665|Drug|Voriconazole|
12083996|NCT00015626|Drug|Metformin|
12083997|NCT00015626|Procedure|skin biopsy|
12083998|NCT00015626|Behavioral|diet and exercise|
12083999|NCT00015626|Drug|pioglitazone|
12084000|NCT00015626|Drug|rosiglitazone|
12084001|NCT00015600|Behavioral|Behavior modification through social marketing|
12084002|NCT00015548|Drug|Olanzapine|
12084003|NCT00015548|Drug|Quetiapine|
12084004|NCT00015548|Drug|Risperidone|
12084005|NCT00015548|Drug|Citalopram|
12084006|NCT00015457|Drug|Amlodipine plus Botulinum toxin|
12084007|NCT00015015|Drug|Dichloroacetate|
12084008|NCT00015340|Drug|Buprenorphine/naloxone|
12084009|NCT00015301|Drug|Methylphenidate|
12084010|NCT00015288|Drug|Buprenorphine/naloxone|
12084011|NCT00015275|Behavioral|Cocaine-Related Disorders|
12084012|NCT00015249|Drug|Amantadine|
12084013|NCT00015236|Behavioral|Amantadine|
12084014|NCT00015223|Drug|Methylphenidate|
12084015|NCT00015210|Drug|Nefazodone|
12084016|NCT00015210|Behavioral|Psychosocial Treatment|All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
12084017|NCT00015171|Drug|Buprenorphine/naloxone|
12084018|NCT00015132|Drug|Sertraline|
12084019|NCT00015106|Drug|Lamotrigine|
12084020|NCT00015080|Drug|Naltrexone|
12084021|NCT00015067|Drug|Methylphenidate|
12084022|NCT00015054|Drug|Methylphenidate|
12084023|NCT00015041|Drug|Buprenorphine|
12084024|NCT00015028|Drug|Buprenorphine/naloxone|
12084025|NCT00015002|Drug|Betamethasone|"coded study medication is 12 mg of betamethasone (or placebo) given as 2 ml intramuscular injection in 2 doses, 24 hours apart (the Course). Patients administered weekly courses for 4 weeks, until 33 weeks 6 days gestation or delivery, whichever occurs first."
12084026|NCT00014989|Drug|magnesium sulfate|
12084027|NCT00014950|Procedure|CF newborn screening|
12084028|NCT00014833|Other|No intervention|No intervention
12084029|NCT00014807|Behavioral|Reducing Pesticide Exposure in Minority Families|
12084030|NCT00014794|Drug|15-O labeled water|
12084031|NCT00014768|Drug|glucose|
12084032|NCT00014768|Drug|insulin|
12084033|NCT00014768|Drug|leucine|
12084034|NCT00014755|Drug|anti-thymocyte globulin|
12084035|NCT00014755|Drug|cyclophosphamide|
12084036|NCT00014755|Drug|filgrastim|
12084037|NCT00014755|Drug|prednisone|
12084038|NCT00014755|Procedure|peripheral blood stem cell transplantation|
12084039|NCT00014755|Procedure|irradiation|
12084040|NCT00014742|Drug|collagenase|
12084041|NCT00014729|Drug|isotretinoin|
12084042|NCT00014040|Drug|Nitric Oxide and INOpulse Delivery System|
12084043|NCT00014027|Drug|Docosahexaenoic acid (DHA)|
12084044|NCT00014027|Drug|Eicosapentaenoic acid|
12084045|NCT00014001|Drug|perphenazine|
12084046|NCT00014001|Drug|olanzapine|
12084047|NCT00014001|Drug|quetiapine|
12084048|NCT00014001|Drug|risperidone|
12084049|NCT00014001|Drug|ziprasidone|
12084050|NCT00014001|Drug|clozapine|
12084051|NCT00014001|Drug|fluphenazine decanoate|
12084052|NCT00013962|Drug|Vitamin D|
12084053|NCT00013923|Drug|Nutritional Supplement|
12084054|NCT00013910|Drug|NNC 90-1170|
12084055|NCT00013884|Drug|T-20|
12084056|NCT00013806|Drug|131I-MIBG|
12084057|NCT00013793|Behavioral|Motivational enhancement and ultrasound|
12084058|NCT00013767|Behavioral|Individual and Community education|
12084059|NCT00013741|Behavioral|Tailored Education Messages|
12084060|NCT00013702|Drug|Adefovir|
12084061|NCT00013689|Drug|Fansidar (pyrimethamine and sulfadoxine)|
12084062|NCT00013650|Drug|Cyclophosphamate|
12084063|NCT00013624|Drug|IV Levodopa|
12084064|NCT00013611|Drug|Proleukin|Recombinant IL-2 was given at a dose of 4.5 MIU twice daily subcutaneously for 5 consecutive days every 8 weeks, in addition to antiretroviral therapy, for 6 cycles. After the first 6 cycles, additional cycles were given to either achieve or maintain the patient's CD4+ cell count goal.
12084065|NCT00013598|Drug|Pioglitazone|
12084066|NCT00013546|Drug|TMTDS|
12084067|NCT00013533|Procedure|Stem cell transplantation|>3 x 106/kg CD34+ stem cells by IV infusion
12084068|NCT00013507|Procedure|Falls|
12084069|NCT00013494|Procedure|Stroke Rehabilitation|
12084070|NCT00013481|Procedure|Stroke Rehabilitation|
12084071|NCT00013468|Procedure|Tinnitus|
12084072|NCT00013455|Device|Hearing|
12084073|NCT00013442|Procedure|Auditory Evoked Response|
12084074|NCT00013429|Procedure|Visual|
12084075|NCT00013416|Procedure|Hearing|
12084076|NCT00013403|Procedure|Blindness|
12084077|NCT00013390|Procedure|Tinnitus Masking|"Tinnitus Masking is a widely-used method for providing relief of tinnitus. The central premise of Tinnitus Masking involves the use of wearable ear-level devices (hearing aids, maskers, or combination instruments) that deliver sound to a patient's ear(s). The primary purpose of the sound presentation is to produce a sense of relief from the annoyance caused by the tinnitus sound. The relief is accomplished by either obscuring, or covering up (masking) the tinnitus sound, or by changing the sound of the tinnitus in some way, usually by reducing its loudness (Vernon, Meikle)."
12084078|NCT00013390|Procedure|Tinnitus Retraining Therapy|"Tinnitus Retraining Therapy (TRT) was derived from a purely psychological approach for facilitating tinnitus habituation (Hallam et al). The current method is based on neurophysiological principles, and aims at retraining brain regions that are involved in processing the tinnitus signal, without attempting to suppress generation of the signal (Jastreboff). The retraining involves a systematic effort aimed at decreasing both the detectability of tinnitus and the transmission of the tinnitus signal to emotional centers of the brain. Habituation of tinnitus thus purportedly occurs at two levels: habituation of emotional reactions to the tinnitus and habituation of tinnitus perception. Habituation is achieved by utilizing directive counseling, along with the use of low-level broadband noise to reduce the detectability of tinnitus for patients with normal or near-normal hearing. When hearing loss is a significant problem to the patient, appropriate hearing aids are fitted."
12084079|NCT00013377|Procedure|Low vision|
12084080|NCT00013364|Behavioral|Talker variability|
12084081|NCT00013351|Procedure|Prevention of Falls|
12084082|NCT00013338|Procedure|Ambulation Training|
12084083|NCT00013325|Procedure|Cardiac Disease|
12084084|NCT00013312|Procedure|Determine colonic tone|
12084085|NCT00013299|Device|Prevention of Diabetic Ulcers|
12084086|NCT00013286|Device|Prevention Diabetic Foot Ulcer|
12084087|NCT00013273|Procedure|Physical Conditioning|
12084088|NCT00013260|Procedure|Integrated model of primary care|
12084089|NCT00013247|Behavioral|Prostate Cancer Screening Education|
12084090|NCT00013234|Procedure|Teledermatology|
12084091|NCT00013221|Behavioral|Exercise|
12084092|NCT00013208|Behavioral|Case Management|
12084093|NCT00013195|Behavioral|Telephone Care|
12084094|NCT00013182|Behavioral|social activity|
12084095|NCT00013169|Behavioral|Strong Patient Focus|
12084096|NCT00013156|Procedure|Effectiveness of Lung Reduction Therapy|
12084097|NCT00013143|Behavioral|Patient risk profiling (potential ADEs) w/provider feedback|
12084098|NCT00013130|Behavioral|Provision of health status information to patients provider|
12084099|NCT00013117|Behavioral|Telephone specialist consultation|
12084100|NCT00013091|Behavioral|Self-management therapy; Psychoeducational group therapy|
12084101|NCT00013078|Procedure|Physical restoration intervention|
12084102|NCT00013052|Behavioral|Peer led classes. Led by trained veterans with a chronic disease.|
12084103|NCT00013039|Behavioral|Computer reminders|
12084104|NCT00013026|Behavioral|CHF Self-management Education (Web-based Education)|
12084105|NCT00013013|Procedure|Systems Support|
12084106|NCT00013000|Behavioral|Test strategy for implementation guideline|
12084107|NCT00012987|Behavioral|Quality Improvement|
12084108|NCT00012974|Behavioral|GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)|
12084109|NCT00012974|Procedure|Provider education, computer reminders, nurse case management|
12084110|NCT00012948|Procedure|Telephone Care|
12084111|NCT00012935|Behavioral|Help with decision making on prostate cancer treatment|
12084112|NCT00012922|Behavioral|Low Literacy Intervention for Colorectal Cancer Screening|
12084113|NCT00012909|Behavioral|Hormone Replacement Therapy Decision-Aid|
12084114|NCT00012896|Behavioral|Telephone Care + Educational (AV Materials)|
12084115|NCT00012883|Behavioral|Homewalking exercise program|
12084116|NCT00012870|Behavioral|Behavioral Management|
12084117|NCT00012857|Drug|acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN|
12084118|NCT00012844|Device|Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed|
12084119|NCT00012844|Procedure|Redesigned patient handling tasks using work practice controls: setting bed height at correct level; applying anti-embolism stockings from foot of bed|
12084120|NCT00012818|Behavioral|relaxation technique|
12084121|NCT00012818|Behavioral|educational program|
12084122|NCT00012805|Procedure|Telephone Monitoring|
12084123|NCT00012792|Behavioral|Exercise Training|
12084124|NCT00012779|Behavioral|Health Education Program|
12084125|NCT00012766|Behavioral|Integrated team care|
12084126|NCT00012753|Procedure|Automated telephone health status assessments with nurse follow-up.|
12084127|NCT00012740|Behavioral|Casefinding and Referral System|
12084128|NCT00012727|Procedure|Matching Symptom Severity to Service Intensity|
12084129|NCT00012714|Behavioral|Case management services|
12084130|NCT00012688|Drug|Doxycycline HCI 10mg po for 2 weeks|
12084131|NCT00012688|Procedure|Ultrasonic scaling with 0.12% chlorhexidine gluconate|
12084132|NCT00012662|Behavioral|Diabetes Self Management Education|
12084133|NCT00012636|Procedure|Computer generated statements about guideline concordance of drug therapy deliver to clinicians|
12084134|NCT00012610|Procedure|Telepsychiatry|
12084135|NCT00012597|Procedure|Web-based telemedicine system for assessment of status of pressure ulcers|
12084136|NCT00012584|Drug|methylphenidate|
12084137|NCT00012584|Drug|fluvoxamine|
12084138|NCT00012558|Drug|lithium|
12084139|NCT00012558|Drug|valproate|
12084140|NCT00012558|Drug|bupropion|
12084141|NCT00012558|Drug|paroxetine|
12084142|NCT00012558|Drug|lamotrigine|
12084143|NCT00012558|Drug|risperidone|
12084144|NCT00012558|Drug|inositol|
12084145|NCT00012558|Drug|tranylcypromine|
12084146|NCT00012558|Behavioral|Cognitive Behavioral Therapy|
12084147|NCT00012558|Behavioral|Family-focused Therapy|
12084148|NCT00012558|Behavioral|Interpersonal and Social Rhythms Therapy|
12084149|NCT00012506|Drug|TNFR:Fc|
12084150|NCT00012441|Procedure|hemodialysis|
12084151|NCT00011908|Drug|hLL2 (Epratuzumab)|
12084152|NCT00011830|Drug|G-CSF|
12084153|NCT00011830|Procedure|Apheresis|
12084154|NCT00011804|Drug|Topiramate|
12084155|NCT00011778|Drug|bortezomib|
12084156|NCT00011778|Radiation|radiation therapy|
12084157|NCT00011765|Drug|Fluoxetine|
12084158|NCT00011752|Drug|FCWAY|
12084159|NCT00011713|Other|Completion questionnaires/providing biological samples|Participant completes baseline interview at enrollment, then completes online questionnaire on lifestyle and medical history. Diet questionnaire is completed at home and mailed back. Online questionnaire about personal care product use and medications is completed at each scheduled study visit.
12084160|NCT00011661|Behavioral|Education on behaviors to reduce lead exposure|
12084161|NCT00011622|Device|Continuous ambulatory subcutaneous glucose monitor|
12084162|NCT00011609|Device|Robotic Arm|
12084163|NCT00011596|Procedure|Gait Training|
12084164|NCT00011583|Device|Robot-assisted therapy|1 hour/day of mechanically-assisted upper limb therapy
12084165|NCT00011583|Device|Traditional therapy|1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
12084166|NCT00011570|Device|Bladder & Bowel Control|
12084167|NCT00011557|Device|Assistance in Voiding|
12084168|NCT00011544|Procedure|Performance Measure|
12084169|NCT00011531|Procedure|Prevention of Pressure Ulcers|
12084170|NCT00011505|Drug|G-CSF|
12084171|NCT00011505|Procedure|Leukapheresis|
12084339|NCT00006565|Device|Placebo Filtration Unit|Placement of inactive filtration unit in the homes
12084340|NCT00006519|Drug|Capravirine|
12084172|NCT00011414|Drug|Tariquidar|IV alone for 1 dose (Day -1), then in combo for rest of cycle (Day 1, etc). Given in combo with one of the following: Doxorubicin (50 mg/m2 IV over 15 min on day 1), Vinorelbine (20 mg/m2 IV over 10 min on days 1 and 8), or Docetaxel (75 mg/m2 IV over 60 min on day 1).
12084173|NCT00011375|Drug|Rolipram|
12084174|NCT00011362|Drug|Dexamethasone Early|Tapering course of dexamethasone in doses given twice a day (0.25 mg per kilogram of body weight per dose for five days, then 0.15 mg, 0.07 mg, and 0.03 mg per kilogram per dose for three days each), followed by two weeks of saline.
12084175|NCT00011362|Drug|Dexamethasone Late|Saline for two weeks, followed by either the same tapering two-week course of dexamethasone given to the first group, if the respiratory-index score was >=2.4 on treatment day 14, or an additional two weeks of saline
12084176|NCT00011297|Drug|gabapentin (Neurontin)|
12084177|NCT00011297|Drug|lorazepam (Ativan)|
12084178|NCT00011258|Drug|Paraoxonase|
12084179|NCT00011141|Drug|Oral lactobacillus administration|
12084180|NCT00011193|Behavioral|Exercise|Compared the effect of 50%, 100%, and 150% of the NIH Consensus Development Panel recommended physical activity dose on fitness in women.
12084181|NCT00011076|Drug|Pirfenidone|
12084182|NCT00011115|Behavioral|Weight loss motivations|
12084183|NCT00011102|Behavioral|Weight Gain Prevention for Women Project|
12084184|NCT00011024|Procedure|Self Hypnosis|
12084185|NCT00011024|Procedure|Acupuncture|
12084186|NCT00011024|Procedure|Osteopathic Manipulation|
12084187|NCT00010998|Procedure|Yoga|
12084188|NCT00010985|Procedure|Acupuncture|
12084189|NCT00010985|Procedure|Chiropractic|
12084190|NCT00010985|Procedure|massage|
12084191|NCT00010972|Procedure|Acupuncture|
12084192|NCT00010959|Drug|Cimicifuga racemosa|
12084193|NCT00010959|Drug|Trifolium pratense|
12084194|NCT00010946|Procedure|Acupuncture|
12084195|NCT00010933|Drug|chamomile tea|
12084196|NCT00010933|Procedure|Relaxation/Guided Imagery|
12084197|NCT00010920|Drug|Ginkgo Biloba Extract|
12084198|NCT00010907|Drug|NPI-028|
12084199|NCT00010881|Drug|antioxidants|
12084200|NCT00010881|Behavioral|stress reduction|
12084201|NCT00010868|Drug|Omega-3 Fatty Acids|
12084202|NCT00010855|Behavioral|Self-hypnotic relaxation|
12084203|NCT00010842|Drug|Ginkgo biloba|
12084204|NCT00010842|Drug|Alpha-lipoic acid|
12084205|NCT00010842|Drug|Vitamin E/Selenium|
12084206|NCT00010842|Drug|Essential fatty acids|
12084207|NCT00010829|Behavioral|American Heart Association Step 1 diet|
12084208|NCT00010829|Behavioral|American Heart Association Step 2 diet + 10 g/day flax seed|
12084209|NCT00010829|Behavioral|Macrobiotic dietary intervention|
12084210|NCT00010816|Drug|Herbal remedies|
12084211|NCT00010803|Drug|Ginkgo biloba|120mg twice a day
12084212|NCT00010803|Drug|Placebo|One pill twice daily
12084213|NCT00010777|Procedure|Multiple Component Mind/Body therapy|
12084214|NCT00010764|Procedure|Acupuncture|
12084215|NCT00010751|Procedure|Reiki|
12084216|NCT00010738|Procedure|Meditation|
12084217|NCT00010725|Drug|MAK|
12084218|NCT00010725|Drug|Vitamin Supplements|
12084219|NCT00010712|Drug|Black Cohosh|
12084220|NCT00010699|Drug|Vitamin E|
12084221|NCT00010686|Drug|Dietary Phytoestrogens|
12084222|NCT00010634|Drug|Connective Tissue Nutrient Formula|
12084223|NCT00010634|Drug|Adaptogenic herbs|
12084224|NCT00010634|Drug|glutamine|
12084225|NCT00010621|Procedure|Acupuncture|
12084226|NCT00010621|Procedure|chiropractic therapy|
12084227|NCT00010621|Procedure|bodywork therapy|
12084228|NCT00010608|Behavioral|Transcendental Meditation|a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.
12084229|NCT00010608|Behavioral|Health Education|didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake
12084230|NCT00010530|Procedure|Meditation|
12084231|NCT00010517|Procedure|Acupuncture|
12084232|NCT00010504|Procedure|Acupuncture|
12084233|NCT00010491|Procedure|Acupuncture|
12084234|NCT00010491|Procedure|Moxibustion|
12084235|NCT00010478|Procedure|Acupuncture|
12084236|NCT00010465|Procedure|Craniosacral Osteopathic Manipulative Treatment|
12084237|NCT00010465|Drug|Botanicals|
12084238|NCT00009685|Drug|VRC4302|
12084239|NCT00009672|Drug|Nortriptyline|
12084240|NCT00009672|Drug|Morphine|
12084241|NCT00009659|Drug|CDB 2914|
12084242|NCT00009646|Drug|indomethacin|Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa
12084243|NCT00009646|Drug|Indomethacin|0.1 mg per kilogram of body weight
12084244|NCT00009646|Drug|Placebo|0.1 mg per kilogram of body weight
12084245|NCT00009620|Drug|Phenobarbital|10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)
12084246|NCT00009620|Drug|Saline|Infusion of normal sal
12084247|NCT00010452|Drug|picibanil|Up to .2 mg per injection, given intralesionally every 6-8 weeks
12084248|NCT00010439|Drug|Alendronate|Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.
12084249|NCT00010426|Drug|cysteamine hydrochloride|
12084250|NCT00010413|Drug|cyclophosphamide|
12084251|NCT00010413|Drug|filgrastim|
12084252|NCT00010400|Drug|Cyclophosphamide|
12084253|NCT00010400|Drug|filgrastim|
12084254|NCT00010387|Drug|cyclophosphamide|
12084255|NCT00010387|Drug|filgrastim|
12084256|NCT00010374|Device|NeuRx DPS|Laparoscopic implantation of diaphragm electrodes and subsequent pacing with the NeuRx DPS.
12084257|NCT00010361|Drug|cyclosporine|
12084258|NCT00010361|Drug|fludarabine|
12084259|NCT00010361|Drug|mycophenolate mofetil|
12084341|NCT00006517|Device|bright light box|10,000 lux bright light therapy
12084260|NCT00010335|Procedure|Stem Cell Transplantation|Participants will receive a stem cell transplantation along with irradiation and the drugs anti-thymocyte globulin, cyclophosphamide, and filgrastim as noted in the text of this record.
12084261|NCT00010335|Device|CD34 selection|CD34+ cells are separated from the rest of the peripheral blood stem cells.
12084262|NCT00009594|Procedure|Naturopathic Medicine|
12084263|NCT00009594|Procedure|Traditional Chinese Medicine|
12084264|NCT00009581|Drug|L-NMMA|
12084265|NCT00009581|Drug|Acetylcholine|
12084266|NCT00009230|Drug|Celecoxib|
12084267|NCT00009217|Drug|Haloperidol-Haloperidol|Haloperidol open label flexible dose 1-5 mg daily for 20 weeks followed by haloperidol double-blind 1-5 mg for 24 weeks
12084268|NCT00009217|Drug|Haloperidol-Placebo|Haloperidol open-label flexible dose of 1-5 mg for 20 weeks followed by placebo double-blind for 24 weeks
12084269|NCT00009204|Drug|Citalopram [Celexa]|
12084270|NCT00009204|Drug|Perphenazine [Trilafon]|
12084271|NCT00009191|Drug|Sertraline [Zoloft]|
12084272|NCT00009048|Drug|EMD 128130|
12084273|NCT00009048|Drug|IV Levodopa|
12084274|NCT00009178|Drug|Fluoxetine|
12084275|NCT00009178|Behavioral|Guided Self-Help|
12084276|NCT00009009|Drug|immunosuppressive regimen designed to complement HAART|
12084277|NCT00008801|Drug|hOKT3gamma1 (Ala-ala)|
12084278|NCT00008775|Device|Pressure support ventilation|
12084279|NCT00008736|Drug|metoclopramide|
12084280|NCT00008827|Behavioral|Behavioral weight loss|
12084281|NCT00008515|Drug|Fluocinolone|
12084282|NCT00008476|Drug|Capsaicin|
12084283|NCT00008450|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplant
12084284|NCT00008450|Drug|Cyclosporine|Given PO or IV
12084285|NCT00008450|Other|Laboratory Biomarker Analysis|Correlative studies
12084286|NCT00008450|Drug|Mycophenolate Mofetil|Given PO or IV
12084287|NCT00008450|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo nonmyeloablative allogeneic hematopoietic stem cell transplant
12084288|NCT00008450|Radiation|Total-Body Irradiation|Undergo TBI
12084289|NCT00007800|Behavioral|Behavioral Group Weight Loss Intervention|
12084290|NCT00007800|Behavioral|Motivational Interviewing|
12084291|NCT00007670|Drug|Carbamazepine|
12084292|NCT00007670|Drug|Gabapentin|
12084293|NCT00007670|Drug|Lamotrigine|
12084294|NCT00007657|Procedure|Intensive medical therapy|
12084295|NCT00007657|Procedure|Percutaneous Coronary Intervention (PCI) plus intensive medical therapy|
12084296|NCT00007774|Drug|Haloperidol|
12084297|NCT00007774|Drug|Olanzapine|
12084298|NCT00007761|Behavioral|Bipolar Disorder Program|
12084299|NCT00007761|Behavioral|Usual (psychiatric) Care|
12084300|NCT00007748|Behavioral|Aerobic exercise|
12084301|NCT00007748|Behavioral|Cognitive behavioral therapy|
12084302|NCT00007735|Drug|Doxycycline (200mg/day) or Placebo|
12084303|NCT00007683|Drug|Warfarin titrated to an INR of 2.5-3.0|anticoagulation (administered without blinding) titrated to a target INR of 2.5 to 3.0, monitored by measurements at 6 week intervals after initial titration and stabilization.
12084304|NCT00007683|Drug|Aspirin|an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
12084305|NCT00007683|Drug|Clopidogrel 75|(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
12084306|NCT00007644|Procedure|Radical prostatectomy|Surgical removal of the prostate
12084307|NCT00007631|Drug|Tretinoin 0.1% cream or placebo|
12084308|NCT00007631|Other|Placebo|Patients receive placebo for same amount of time
12084309|NCT00007605|Drug|Amiodarone|Patients assigned will receive 400 mg bid for 14 days, 400 mg QAM and 200 mg QHS for 14 days, 300 mg qd for 48 weeks, then 200 mg qd.
12084310|NCT00007605|Drug|Sotalol|Patients assigned will receive 80 mg bid for 7 days and 160 mg bid thereafter.
12084311|NCT00007592|Drug|Chlorthalidone|
12084312|NCT00007592|Drug|Furosemide|
12084313|NCT00007527|Drug|naloxone|
12084314|NCT00007527|Drug|buprenorphine|
12084315|NCT00007501|Biological|Varicella-zoster vaccine|Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
12084316|NCT00007501|Biological|Placebo|Placebo vaccine
12084317|NCT00007475|Procedure|Plasma exchange|A course of plasma exchange of 5 treatments over 10 days, then administration of cyclophosphamide.
12084318|NCT00007475|Drug|Cyclophosphamide|For GFR > 50 ml/min/1.73 m2 received oral cyclophosphamide at a dose of 2 mg/kg/ day for 3 months. For GFR < 50 ml/min/1.73 m2 but > 10 ml/min/1.73 m2 will receive oral cyclophosphamide at a 25% reduced dose or 1.5 mg/kg/d for 3 months.
12084319|NCT00007358|Drug|Dexamethasone or other corticosteroid|Administered during the third trimester of pregnancy
12084320|NCT00007345|Drug|Romidepsin|
12084321|NCT00007306|Drug|Parathyroid hormone ointment|
12084322|NCT00007293|Device|UV-B Lightsource and Fiber Optic Comb|
12084323|NCT00007280|Device|Bioengineered skin|
12084324|NCT00007267|Behavioral|Cognitive behavioral therapy|
12084325|NCT00007267|Behavioral|Disease/health education|
12084326|NCT00007267|Behavioral|Self-help cognitive behavioral intervention facilitated by a psychologist|
12084327|NCT00007254|Drug|Pain relief for pressure ulcers|
12084328|NCT00007241|Device|Isometric exercise|
12084329|NCT00007189|Drug|Naproxen Sodium (Aleve)|
12084330|NCT00007189|Drug|Celecoxib (Celebrex)|
12084331|NCT00007163|Drug|J695|
12084332|NCT00007150|Procedure|Phlebotomy|Therapeutic phlebotomy, the periodic, frequent removal of iron contained in the hemoglobin of red blood cells.
12084333|NCT00007085|Device|Tomography, X-ray Computed|
12084334|NCT00007059|Drug|mycophenolate mofetil|
12084335|NCT00007033|Drug|magnesium gluconate|
12084336|NCT00007033|Drug|magnesium sulfate|
12084337|NCT00007020|Drug|Cholic Acids|10-15 mg/kg body weight/day taken orally.
12084338|NCT00006565|Device|HEPA Air Cleaner|Placement of two active HEPA air cleaners in the homes of children
12084342|NCT00006517|Device|dawn simulator|gradual rise in bedroom illumination prior to wake-up
12084343|NCT00006517|Device|high-output negative ion generator|automated air ion delivery in bedroom prior to wake-up
12084344|NCT00006517|Device|low-output negative ion generator|automated air ion delivery in bedroom prior to wake-up
12084345|NCT00006517|Device|dawn light pulse|rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up
12084346|NCT00006516|Behavioral|Infant stimulation|
12084347|NCT00006508|Procedure|Controlled hypoglycemia using insulin|
12084348|NCT00006508|Procedure|formula meal|
12084349|NCT00006505|Drug|Islet Transplantation|Islet cell transplantation. This study will test whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy
12084350|NCT00006501|Procedure|ECG|A diagnostic tool that is routinely used to assess the electrical and muscular functions of the heart (non-experimental).
12084351|NCT00006493|Drug|Rosiglitazone|
12084352|NCT00006489|Behavioral|Cognitive-Behavioral Therapy|Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
12084353|NCT00006489|Drug|Naltrexone|Daily dosing 100 mg for 24 weeks
12084354|NCT00006489|Drug|Placebo|Pill Placebo daily dosing 24 weeks
12084355|NCT00006488|Drug|recombinant-methionyl human glial cell line-derived neurotrophic factor|
12084356|NCT00006450|Drug|Phenylbutyrate|
12084357|NCT00006449|Drug|naltrexone (Revia)|
12084358|NCT00006449|Behavioral|broad spectrum treatment|
12084359|NCT00006449|Behavioral|motivational enhancement therapy|
12084360|NCT00006507|Behavioral|Occupational Therapy|
12084361|NCT00006448|Behavioral|cognitive therapy|
12084362|NCT00006448|Procedure|Physical Therapy|
12084363|NCT00006448|Drug|Methadone|
12084364|NCT00006447|Procedure|Social Support|
12084365|NCT00006446|Procedure|Training in parenting skills and communication|
12084366|NCT00006445|Procedure|Ultrasound|
12084367|NCT00006445|Procedure|Serum screen|
12084368|NCT00006439|Behavioral|Counseling in the home|
12084369|NCT00006438|Device|Shoes with Rocker Soles|
12084370|NCT00006436|Biological|Rituximab|2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
12084371|NCT00006436|Biological|filgrastim|Figrastim day 6 until ANC reaches 5000 after the nadir, every cycle
12084372|NCT00006436|Drug|EPOCH|combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
12084373|NCT00006434|Biological|tumor-pulsed dendritic cells|
12084374|NCT00006433|Drug|Doxil|
12084375|NCT00006433|Procedure|heat treatment|
12084376|NCT00006432|Procedure|very low fat diet|
12084377|NCT00006431|Biological|DC RCC-RNA|
12084378|NCT00006430|Biological|Autologous dendritic cells transfected with amplified tumor RNA|
12084379|NCT00006429|Procedure|body weight-supported treadmill training|
12084380|NCT00006428|Drug|Amitriptyline|
12084381|NCT00006427|Drug|Amitriptyline|
12084382|NCT00006426|Procedure|Achilles tendon-lengthening surgery|
12084383|NCT00006422|Procedure|current standard of care treatments|
12084384|NCT00006418|Procedure|DNA collection|
12084385|NCT00006417|Procedure|Stem cell transplantation|
12084386|NCT00006413|Procedure|Stem cell transplantation|
12084387|NCT00006411|Other|corneas assigned by donor age group|A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.
12084388|NCT00006409|Behavioral|Trial of Activity for Adolescent Girls (TAAG)|Intervention activities were designed to create (1) environmental and organizational changes supportive of physical activity and (2) cues, messages, and incentives to be more active. The intervention was designed to establish more opportunities, improve social support and norms, and increase self-efficacy, outcome expectations, and behavioral skills to foster greater moderate-vigorous physical activity (MVPA). An innovative feature of TAAG was linking school and community agencies to promote activity programs for girls. Finally, a TAAG Program Champion component was developed to foster sustainability after the 2-year staff-directed intervention. TAAG investigators recruited and trained Program Champions during the staff-directed intervention phase to promote maintenance of the program.
12084389|NCT00006405|Behavioral|Exercise|
12084390|NCT00006401|Drug|iNO|Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
12084391|NCT00006401|Other|Placebo|Inhaled Nitrogen
12084392|NCT00006400|Drug|Hydroxyurea|Participants will receive hydroxyurea.
12084393|NCT00006400|Drug|Placebo|Participants will receive placebo.
12084394|NCT00006398|Drug|Timolol Maleate|
12084395|NCT00006398|Drug|Placebo|
12084396|NCT00006394|Drug|growth hormone|
12084397|NCT00006337|Drug|KW-6002|
12084398|NCT00006337|Drug|IV Levodopa|
12084399|NCT00006332|Drug|Tetrathiomolybdate|
12084400|NCT00006331|Procedure|renal transplant|
12084401|NCT00006330|Drug|Digoxin|
12084402|NCT00006330|Drug|Hawthorn|
12084403|NCT00006329|Procedure|Minimally invasive radioguided parathyroidectomy|
12084404|NCT00006320|Procedure|determine blood levels of anti-HIV drugs|
12084405|NCT00006305|Procedure|Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions|Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions
12084406|NCT00006305|Procedure|Coronary Artery Bypass|Coronary Artery Bypass
12084407|NCT00006305|Drug|Biguanides, thiazolidinediones|Biguanides, thiazolidinediones
12084408|NCT00006305|Drug|Insulin, sulfonylurea|Insulin, sulfonylurea
12084409|NCT00006305|Drug|ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers|ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
12084410|NCT00006299|Drug|Celebrex|
12084411|NCT00006294|Drug|Chlorthalidone|participant's drug dose will be titrated from 12.5mg to 25mg over the course of the study
12084412|NCT00006294|Drug|Lisinopril|participant's drug dose will be titrated from 10mg to 40mg over the course of the study
12084413|NCT00006294|Drug|Amlodipine|participant's drug dose will be titrated from 10mg to 40mg over the course of the study
12084414|NCT00006294|Drug|Doxazosin|participant's drug dose will be titrated from 2mg to 8mg over the course of the study
12084415|NCT00006292|Drug|Infliximab|
12084416|NCT00006289|Drug|Placebo|4 tabs b.i.d.
12084417|NCT00006289|Drug|Neurotropin|4 tabs b.i.d.
12084418|NCT00006286|Drug|Fluoxetine|
12084419|NCT00006286|Behavioral|Psychotherapy|
12084420|NCT00006276|Drug|Micellar Paclitaxel|
12084421|NCT00006280|Drug|Tobramycin for Inhalation|
12084422|NCT00006275|Drug|calcitriol|
12084423|NCT00006270|Drug|cosyntropin|
12084424|NCT00006270|Drug|metyrapone|
12084425|NCT00006206|Drug|naltrexone (Revia)|
12084426|NCT00006206|Drug|acamprosate (Campral)|
12084427|NCT00006205|Drug|ondansetron + cognitive behavioral therapy|ondansetron (4 mcg/kg b.i.d)
12084428|NCT00006205|Drug|topiramate + cognitive behavioral therapy|topiramate (up to 300 mg/day)
12084429|NCT00006205|Drug|Placebo + cognitive behavioral therapy|placebo
12084430|NCT00006205|Drug|ondansetron + topiramate + cognitive behavioral therapy|ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
12084431|NCT00006204|Drug|naltrexone (Revia)|
12084432|NCT00006204|Drug|fluoxetine (Prozac)|
12084433|NCT00006203|Drug|naltrexone (Revia)|
12084434|NCT00006202|Drug|Lutein|
12084435|NCT00006200|Drug|thalidomide|
12084436|NCT00006200|Drug|dacarbazine|
12084437|NCT00006199|Drug|R115777 (farnesyl transferase inhibitor)|
12084438|NCT00006199|Drug|Topotecan|
12084439|NCT00006198|Drug|thalidomide|
12084440|NCT00006198|Procedure|chemoembolization with doxorubicin/collagen|
12084441|NCT00006196|Drug|Vitamin D|
12084442|NCT00006195|Drug|risperidone|
12084443|NCT00006195|Drug|olanzapine|
12084444|NCT00006194|Behavioral|Exercise|
12084445|NCT00006193|Behavioral|diet|
12084446|NCT00006190|Drug|Nelfinavir mesylate|
12084447|NCT00006190|Drug|Stavudine|
12084448|NCT00006190|Drug|Lamivudine|
12084449|NCT00006190|Drug|Efavirenz|
12084450|NCT00006187|Drug|Investigational drug|
12084451|NCT00006186|Procedure|Autologous fresh whole blood|
12084452|NCT00006184|Drug|Myeloma Immunoglobulin Idiotype Vaccine|3 subcutaneous (SC) injections of myeloma protein within 10 weeks before stem cell collection the first (week 0), second (week 2), and third injection (week 6) with Id-KLH (0.5 mg SC day 1)
12084453|NCT00006184|Drug|Bortezomib|Induction chemotherapy: 1.3 mg/m^2 bolus intravenous injection twice weekly for 2 weeks (days 1, 4, 8, 11) followed by 10 day rest period (day 12-21)
12084454|NCT00006184|Drug|Cyclophosphamide|Induction chemotherapy: 600 mg/m^2 day 4 Transplant: 1200 mg/m^2 intravenous x 4 days (days -6, -5, -4, -3)
12084455|NCT00006184|Drug|Cyclosporine|Transplant: 2 mg/kg intravenous every 12 hours continuous intravenous or by mouth (PO) until day + 180
12084456|NCT00006184|Drug|Doxorubicin hydrochloride|Induction chemotherapy: 10 mg/m^2 day continuous intravenous (CIV) days 1-3
12084457|NCT00006184|Drug|Etoposide|Induction chemotherapy: 50 mg/m^2 day continuous intravenous days 1-3
12084458|NCT00006184|Drug|Fludarabine phosphate|Induction chemotherapy: 25 mg/m^2 day intravenous days 1-3 Transplant: 30 mg/m^2 day x 4 days (days -6, -5, -4, -3 )
12084459|NCT00006184|Drug|Prednisone|60 mg/m^2 day 1-4
12084460|NCT00006184|Drug|Vincristine Sulfate|Induction chemotherapy: 0.5 mg/m^2 day continuous intravenous days 1-3
12084461|NCT00006184|Drug|Methotrexate|Transplant: 5 mg/m^2 intravenous on days +1, +3, +6, +11
12084462|NCT00006184|Biological|GMCSF (granulocyte macrophage colony stimulating factor)|250 mcg/m^2 subcutaneously every day, days 1-4
12084463|NCT00006184|Biological|GCSF (granulocyte colony stimulating factor)|10 mcg/kg per day subcutaneously daily from day 5 until absolute neutrophil count (ANC) > 1000/ul x 2 days
12084464|NCT00006185|Drug|Avandia administration for 6-12 weeks|
12084465|NCT00006183|Procedure|Cardiopulmonary Bypass with Two Different Intra-Operative Hematocrits|
12084466|NCT00006183|Procedure|Thoracic Surgery|
12084467|NCT00006182|Procedure|Blood Transfusion|
12084468|NCT00006399|Drug|Donepezil|
12084469|NCT00006399|Drug|Estrogen|
12084470|NCT00006399|Drug|Progesterone|
12084471|NCT00006181|Behavioral|Team-based intervention|
12084472|NCT00006181|Behavioral|One-on-one intervention|
12084473|NCT00006180|Drug|Alendronate|
12084474|NCT00006178|Drug|Sirolimus|
12084475|NCT00006178|Drug|Thymoglobulin|
12084476|NCT00006174|Drug|Letrozole|
12084477|NCT00006172|Device|Bright light box|60-min light therapy shortly after awakening
12084478|NCT00006172|Device|High-output negative ion generator|60-min high-density ion exposure shortly after awakening
12084479|NCT00006172|Device|Low-output negative ion generator|60-min low-density ion exposure shortly after awakening
12084480|NCT00006170|Drug|Bupropion|smoking cessation medication aid
12084481|NCT00006170|Drug|Placebo|A matched placebo pill
12084482|NCT00006170|Behavioral|weight concerns intervention|cognitive behavioral treatment to address weight concners
12084483|NCT00006170|Behavioral|smoking cessation intervention|Cognitive behavioral intervention for smoking cessation
12084484|NCT00006156|Other|Control|No injection of FSH
12084485|NCT00006156|Drug|Drug: FSH|FSH Stimulation Test
12084486|NCT00006169|Behavioral|Behavioral Treatment|
12084487|NCT00006168|Drug|Methotrexate|
12084488|NCT00006167|Drug|oxandrolone|
12084489|NCT00006167|Behavioral|Progressive Resistance Training|
12084490|NCT00006166|Procedure|Transjugular intrahepatic portasystemic shunts (TIPS)|
12084491|NCT00006166|Procedure|Total paracentecis (TP)|
12084492|NCT00006165|Behavioral|'Ohana (Family) Support Lifestyle Intervention|
12084493|NCT00006164|Drug|Peginterferon alfa-2a + Ribavirin|Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight <75 kg, >75 kg) daily in two divided doses for 24 weeks
12084494|NCT00006164|Drug|Peginterferon alfa-2a|90 mcg/week injection, for 3.5 years
12084495|NCT00006163|Behavioral|Personalized Self-management|
12084496|NCT00006163|Behavioral|Community Resources|
12084497|NCT00006162|Behavioral|exercise and diet|
12084498|NCT00006161|Procedure|Transjugular Intrahepatic Portosystemic Shunt (TIPS)|
12084499|NCT00006161|Procedure|Distal Splenorenal Shunt|
12084500|NCT00006160|Behavioral|home based worker|
12084501|NCT00006159|Behavioral|lifestyle (exercise, diet, and family and community support)|
12084502|NCT00006158|Drug|Testosterone|
12084503|NCT00006157|Drug|Desipramine|
12084504|NCT00006157|Behavioral|Cognitive Behavioral Treatment|
12084505|NCT00006151|Behavioral|Behavioral Therapy|Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
12084506|NCT00006077|Drug|NS2330|
12084507|NCT00006077|Drug|Levodopa and Domperidone|
12084508|NCT00006142|Behavioral|phenylalanine restricted diet|
12084509|NCT00006137|Drug|enalapril|
12084510|NCT00006136|Drug|arginine butyrate|
12084511|NCT00006136|Drug|epoetin alfa|
12084512|NCT00006135|Drug|acyclovir|
12084513|NCT00006133|Drug|estradiol|
12084514|NCT00006133|Drug|ethinyl estradiol|
12084515|NCT00006133|Drug|medroxyprogesterone|
12084516|NCT00006133|Drug|norethindrone|
12084517|NCT00006132|Drug|acyclovir|
12084518|NCT00006131|Drug|Valacyclovir|
12084519|NCT00006130|Procedure|Core decompression|
12084520|NCT00006129|Drug|testosterone|
12084521|NCT00006127|Drug|amifostine|
12084522|NCT00006072|Drug|Rituxan|
12084523|NCT00006070|Drug|etanercept (Enbrel)|
12084524|NCT00006068|Procedure|Pancreatic Islet Transplantation|
12084525|NCT00005937|Drug|Antithymocyte globulin|Antithymocyte globulin (ATG) intravenous infusion: 40mg/kg/day. Infusion over 6 hours on day 1-4.
12084526|NCT00005937|Drug|Cyclosporine|Cyclosporine (CsA) intravenous infusion: 5mg/kg. Infusion on day 14 administered twice a day.
12084527|NCT00005935|Drug|Mycophenolate mofetil|
12084528|NCT00005935|Drug|Cyclosporine|
12084529|NCT00005934|Drug|5-Azacytidine|
12084530|NCT00006063|Drug|pancrelipase with bicarbonate|
12084531|NCT00006061|Drug|phosphatidylcholine|
12084532|NCT00006060|Drug|standard gadolinium contrast|
12084533|NCT00006056|Drug|anti-thymocyte globulin|
12084534|NCT00006056|Drug|busulfan|
12084535|NCT00006056|Drug|cyclophosphamide|
12084536|NCT00006056|Drug|cyclosporine|
12084537|NCT00006056|Drug|etoposide|
12084538|NCT00006056|Drug|filgrastim|
12084539|NCT00006056|Drug|methotrexate|
12084540|NCT00006056|Procedure|allogeneic hematopoietic stem cell transplantation|
12084541|NCT00006055|Drug|anti-thymocyte globulin|
12084542|NCT00006055|Drug|cyclophosphamide|
12084543|NCT00006055|Drug|cyclosporine|
12084544|NCT00006055|Drug|filgrastim|
12084545|NCT00006055|Drug|methylprednisolone|
12084546|NCT00006055|Drug|prednisone|
12084547|NCT00006055|Procedure|Autologous Peripheral Blood Stem Cell Transplantation|
12084548|NCT00006054|Drug|anti-thymocyte globulin|
12084549|NCT00006054|Drug|busulfan|
12084550|NCT00006054|Drug|cyclophosphamide|
12084551|NCT00006054|Drug|cyclosporine|
12084552|NCT00006054|Drug|etoposide|
12084553|NCT00006054|Drug|methotrexate|
12084554|NCT00006054|Drug|methylprednisolone|
12084555|NCT00006054|Drug|prednisone|
12084556|NCT00006054|Procedure|Allogeneic Bone Marrow Transplantation|
12084557|NCT00005928|Drug|Ramipril|
12084558|NCT00005925|Drug|Muscimol|
12084559|NCT00005922|Behavioral|Partial schedule of pharmacotherapeutic reinforcement|Dose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks.
12084560|NCT00005922|Drug|Dose control for Arm B|Dose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks.
12084561|NCT00005922|Other|Standard pharmacotherapeutic protocol|Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
12084562|NCT00005916|Drug|rV-PSA|
12084563|NCT00005916|Drug|rF-PSA|
12084564|NCT00005916|Drug|rV-B7.1|
12084565|NCT00005910|Procedure|Intraoperative ultrasound|
12084566|NCT00005908|Drug|Docetaxel - Dose A|Dose A-Cohort 1 Docetaxel 75 mg/m^2 intravenous day 1
12084567|NCT00005908|Drug|Anastrozole|1 mg orally daily for five years
12084568|NCT00005908|Drug|cyclophosphamide|600 mg/m^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1
12084569|NCT00005908|Drug|Docetaxel - Dose B|Dose B - Cohort 2 Docetaxel 60 mg/m^2 intravenous day 1
12084570|NCT00005908|Drug|Doxorubicin hydrochloride|60 mg/m^2 will be administered as a slow intravenous push on day 1
12084571|NCT00005908|Drug|Tamoxifen Citrate|20 mg/day orally for five years
12084572|NCT00005908|Drug|Capecitabine - Dose B|Dose B - Cohort 2 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
12084573|NCT00005908|Drug|Capecitabine - Dose A|capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
12084574|NCT00005906|Drug|Octreotide|Treatment with octreotide starts at a dose of 50 micrograms(ug) twice a day which is increased to 100 ug twice a day after two weeks and to 200 ug twice a day two weeks later. After two months, if there is no response the dose shall be increased to 400 ug twice a day.
12084575|NCT00005905|Drug|hu Leptin (A-100)|
12084576|NCT00005903|Drug|GDNF & Synchro Med Infusion System|
12084577|NCT00005901|Drug|Pamidronate (Aredia)|Patients receive a dose of 1mg/kg/cycle (3-day infusion = 1 cycle)
12084578|NCT00005898|Drug|anti-thymocyte globulin|
12084579|NCT00005898|Drug|cyclophosphamide|
12084580|NCT00005898|Drug|cyclosporine|
12084581|NCT00005898|Drug|filgrastim|
12084582|NCT00005898|Drug|fludarabine|
12084585|NCT00005896|Genetic|Autologous stem cells transduced with FACC retroviral vector|
12084586|NCT00005896|Procedure|Autologous Stem Cell Transplantation|
12084587|NCT00005893|Drug|anti-thymocyte globulin|
12084588|NCT00005893|Drug|busulfan|
12084589|NCT00005893|Drug|cyclophosphamide|
12084590|NCT00005893|Procedure|Bone marrow transplantation|
12084591|NCT00005892|Drug|cyclophosphamide|
12084592|NCT00005892|Procedure|Allogeneic Bone Marrow Transplantation|
12084593|NCT00005891|Drug|cyclophosphamide|
12084594|NCT00005891|Procedure|Allogeneic Bone Marrow Transplantation|
12084595|NCT00005890|Drug|corticotropin|
12084596|NCT00005889|Drug|alanine|
12084597|NCT00005889|Drug|amino acids|
12084598|NCT00005889|Drug|glucagon|
12084599|NCT00005889|Drug|glucose|
12084600|NCT00005889|Drug|glutamine|
12084601|NCT00005889|Drug|glycerol|
12084602|NCT00005889|Drug|insulin|
12084603|NCT00005889|Drug|leucine|
12084604|NCT00005889|Drug|lipids|
12084605|NCT00005889|Drug|urea|
12084606|NCT00005888|Behavioral|Fortified Pasteurized Donor Human Milk supplement|
12084607|NCT00005888|Behavioral|Preterm Formula supplement|
12084608|NCT00005785|Drug|GCSF Mobilized Allogeneic PBSC Cultured w/Cytokines; Transduced w/RV|
12084609|NCT00005782|Drug|Granulocyte colony-stimulating factor|
12084610|NCT00005782|Procedure|Leukapheresis|
12084611|NCT00005780|Drug|EPOCH-R|EPOCH-R for 6 cycles
12084612|NCT00005780|Biological|GM-CSF|GM-CSF monthly with the vaccine for 5 doses
12084613|NCT00005780|Biological|Idiotype vaccine|1 injection of vaccine monthly for 5 doses
12084614|NCT00005778|Drug|High-dose immunoablative therapy|"High dose cyclophosphamide for 4 days.
~NIH monthly IV cytoxan for 6 months followed by quarterly for 2 years."
12084615|NCT00005777|Procedure|Minimal mechanical ventilation management|Partial pressure of carbon dioxide (PCO2) target (>52 mm Hg)
12084616|NCT00005777|Procedure|Routine mechanical ventilation management|Partial pressure of carbon dioxide (PCO2) target <48 mm Hg)
12084617|NCT00005777|Drug|Dexamethasone|Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place.
12084618|NCT00005777|Drug|Placebo|The infants in the placebo groups received equal volumes of saline.
12084619|NCT00005776|Drug|Inhaled nitric oxide|Inhaled Nitric oxide at a concentration of 20 ppm
12084620|NCT00005776|Drug|Placebo|100% Oxygen
12084621|NCT00005775|Drug|Glutamine|Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
12084622|NCT00005775|Drug|Placebo|TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.
12084623|NCT00005774|Drug|Early surfactant|Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
12084624|NCT00005774|Drug|Standard practice|Surfactant according to current center practice, only after initiation of mechanical ventilation.
12084625|NCT00005773|Drug|Inhaled Nitric Oxide|Study gas was initiated at a concentration of 5 ppm, and the dose was increased to 20 ppm when the infant had <=20 mm Hg increase in PaO2 (less than full response).
12084626|NCT00005773|Drug|Standard iNO therapy|Begin a sham initiation of iNO in term and near-term infants in respiratory failure with an oxygenation index (OI) between 15-25; initiated actual iNO therapy based on standard threshold (OI >=25).
12084627|NCT00005772|Device|Induced hypothermia|Whole-body cooling using the Blanketrol II or III Units in the Automatic Control Mode with a YSI 400 series temperature probe placed in the distal esophagus over a 96-hour period
12084628|NCT00005772|Device|Control|Control group: standard care
12084629|NCT00005771|Device|Visual utrasound feedback|
12084630|NCT00005771|Procedure|Abdominal Hollowing Exercise|
12084631|NCT00005770|Device|Acupuncture|
12084632|NCT00005769|Drug|Hormone Replacement Therapy|
12084633|NCT00005768|Drug|Estrogen|
12084634|NCT00005766|Drug|Creatinine|
12084635|NCT00005765|Drug|nicotine|
12084636|NCT00005765|Drug|alcohol|
12084637|NCT00005675|Drug|Oral bovine type I collagen|500 mcg of CI daily for 15 months
12084638|NCT00005675|Drug|Placebo|CI placebo daily for 15 months
12084639|NCT00005674|Drug|Creatine|
12084640|NCT00005743|Behavioral|exercise|
12084641|NCT00005743|Behavioral|weight loss|
12084642|NCT00005739|Behavioral|Community-based directly observed therapy (DOT)|A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
12084643|NCT00005739|Behavioral|Clinic directly observed therapy (DOT)|A traditional self-administered preventive treatment
12084644|NCT00005727|Behavioral|Intervention|Classroom-based nutrition education curriculum designed for individuals with low literacy skills.
12084645|NCT00005724|Behavioral|Computer Program Intervention Group|A user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant.
12084646|NCT00005724|Other|Minimal Intervention Group|Dietary Information pamphlets.
12084647|NCT00005724|Behavioral|Health Counselor Intervention Group|Food for Heart Program - a structured diet treatment program for low income patients with high cholesterol, given by a health counselor at 4 treatment visits.
12084648|NCT00005713|Behavioral|Continuing, preventative care|Training for intervention clinic staff was based on National Asthma Education and Prevention Program guidelines for the diagnosis and management of asthma, and included screening to identify new cases and health education to improve family management.
12084818|NCT00004756|Procedure|Tailored educational program|
12084819|NCT00004756|Procedure|Educational materials|
12084820|NCT00004755|Drug|allopurinol|
12084821|NCT00004755|Drug|glucantime|
12084822|NCT00004754|Drug|epoprostenol|
12084649|NCT00005711|Behavioral|Asthma self-management education|"Treatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma (triggers), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish."
12084650|NCT00005684|Drug|warfarin|
12084651|NCT00005684|Drug|heparin|
12084652|NCT00005555|Behavioral|Exercise|
12084653|NCT00005553|Procedure|Catheter Ablation|
12084654|NCT00005520|Drug|Hydrochlorothiazide|
12084655|NCT00005520|Drug|Candesartan|
12084656|NCT00005399|Other|No interventions|No interventions
12084657|NCT00005398|Other|There is no intervention|No applicable
12084658|NCT00005305|Other|No interventions - observational study|
12084659|NCT00005195|Procedure|Catheter ablation|
12084660|NCT00005137|Other|exercise program|subjects were measured before and after a 20-week long on-site exercise training program
12084661|NCT00005673|Drug|Capravirine|
12084662|NCT00005669|Drug|Metformin HCL|Medication studied for ability to alter body weight and body composition.
12084663|NCT00005669|Drug|Placebo|Control capsules for metformin
12084664|NCT00005666|Procedure|PET scan use in radiotherapy planning|
12084665|NCT00005665|Drug|interferon alpha|
12084666|NCT00005658|Drug|Glycine|
12084667|NCT00005655|Biological|rh IL-12|rhIL-12 will be administered intravenously on days 2, 4, 6, 10, 12 and 14 of each cycle.
12084668|NCT00005655|Biological|rh IL-2|rhIL-2 will be administered intravenously every 8 hours x 3 doses on days 1 and 9 of each cycle.
12084669|NCT00005654|Drug|clomiphene citrate|
12084670|NCT00005654|Drug|metformin|
12084671|NCT00005652|Drug|rituximab|
12084672|NCT00005575|Drug|Imipramine|
12084673|NCT00005575|Behavioral|Cognitive-behavior therapy|
12084674|NCT00005571|Drug|h5G1.1-mAb|
12084675|NCT00005569|Drug|SLPI (Secretory Leukocyte Protease Inhibitor)|
12084676|NCT00005567|Behavioral|Parental knowledge and beliefs about infant sleep position|
12084677|NCT00005566|Behavioral|Desperation Scale|
12084678|NCT00005119|Procedure|Measures of calcium and bone turnover|
12084679|NCT00005117|Drug|pravastatin|
12084680|NCT00005112|Drug|Human recombinant growth hormone|
12084681|NCT00005116|Behavioral|psychotherapy|
12084682|NCT00005110|Drug|Salmeterol|
12084683|NCT00005110|Drug|Albuterol|
12084684|NCT00005108|Drug|Estradiol|
12084685|NCT00005108|Drug|Progesterone|
12084686|NCT00005107|Drug|N-monomethyl-L-arginine|
12084687|NCT00005104|Drug|clomiphene citrate|
12084688|NCT00005104|Drug|metformin|
12084689|NCT00005015|Drug|Fluoxetine|
12084690|NCT00005014|Drug|Risperidone|
12084691|NCT00005013|Drug|Sertraline|
12084692|NCT00005013|Drug|Hypericum perforatum (St. John's wort)|
12084693|NCT00005007|Drug|Etanercept|
12084694|NCT00005006|Drug|Parathyroid Hormone|Alendronate 70mg/week; Teriparatide 20mcg/ day
12084695|NCT00005006|Drug|Alendronate|Alendronate 70mg/week
12084696|NCT00005006|Drug|Teriparatide|Teriparatide 20mcg/day
12084697|NCT00005005|Drug|PTH|
12084698|NCT00005005|Drug|Alendronate|
12084699|NCT00004997|Drug|Leucovorin|
12084700|NCT00004993|Drug|Parathyroid hormone (hPTH 1-34)|
12084701|NCT00004992|Behavioral|Intensive lifestyle|
12084702|NCT00004992|Drug|Metformin|
12084703|NCT00004992|Drug|Placebo|
12084704|NCT00004990|Drug|Dexamethasone|
12084705|NCT00004988|Drug|VNP20009|
12084706|NCT00004984|Drug|Parenteral Insulin|Subcutaneous injections of recombinant human ultralente insulin in the morning and in the evening; the initial dose for each injection was 0.125 U per kilogram of body weight.
12084707|NCT00004984|Other|Close Observation|Study visits every 6 months including an oral glucose tolerance test
12084708|NCT00004984|Drug|Oral Insulin|Capsules oral insulin, 7.5 mg of recombinant human insulin crystals
12084709|NCT00004984|Drug|Placebo|Placebo for oral insulin
12084710|NCT00004983|Behavioral|diabetes self-management education|
12084711|NCT00004982|Drug|Combination Iron Chelation Therapy|
12084712|NCT00004980|Device|repetitive transcranial magnetic stimulation (rTMS)|a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
12084713|NCT00004980|Device|sham stimulation|"132 minutes of stimulation given at 80% motor threshold with coil tilted single wing 45 degrees away from scalp deliverd to TP3 site"
12084714|NCT00004854|Drug|Carvedilol|
12084715|NCT00004853|Biological|Filgrastim|5 microgram/kg/dose SC daily starting 24-36 hours after last dose of chemotherapy until post-nadir ANC >=10,000/microliter
12084716|NCT00004853|Biological|Filgrastim-SD/01|100 microgram/kg SC 24-36 hours after last dose of chemotherapy (single dose)
12084717|NCT00004847|Drug|([18F]-DOPA)|is L 3, 4 dihydroxyphenylalanine (L-DOPA) labeled with the radioactive isotope 18F. In general, PPGLs belong to the group of neuroendocrine tumors. This heterogeneous group of tumors takes up amino acids, transforms them into biogenic amines (dopamine and serotonin) by decarboxylation and stores the amines in vesicles. L DOPA is a precursor of catecholamines (dopamine, norepinephrine and epinephrine). Epinephrine conversion to dopamine is catalyzed by the aromatic amino acid decarboxylase. According to previous and current studies, [18F]-DOPA PET is highly sensitive and specific for detection of PHEO /PGL67-69. However, there are only a few reports in the literature using [18F]-DOPA as a PET agent and particularly for patients with metastatic PPGLs. PET imaging will be done together with either a CT, an MRI or both modalities.
12084718|NCT00004847|Drug|[68Ga]-DOTATATE|is an imaging agent that binds specifically to somatostatin receptors (SSTRs). PPGLs similar to other neuroendocrine tumors express one or more SSTRs1-5. According to previous and current studies, [68Ga]-DOTATATE PET is highly sensitive and specific for the detection of PHEO/PGL and other neuroendocrine tumors.
12084719|NCT00004847|Drug|([18F]-6F-DA)|is an imaging agent developed at the NIH, that may improve specificity and sensitivity in the localization of PPGLs. [18F]-6F-DA enters cells via the membrane norepinephrine transporter. Once inside cells, [18F]-6F- DA is translocated via the vesicular monoamine transporter into storage vesicles, where the radioactivity is concentrated. After injection of [18F]-6F- DA, the much faster disappearance of [18F]-6F-DA-derived radioactivity from the bloodstream and non- neuronal cells than from chromaffin cells should enable rapid visualization of PPGLs by PET scanning.
12084720|NCT00004846|Drug|ABC/Gen-Probe/Chiron HIV-1/HCV 001|
12084721|NCT00004739|Drug|Antiretroviral therapy|
12084722|NCT00004845|Drug|Rofecoxib|
12084723|NCT00004845|Drug|Naproxen|
12084724|NCT00004734|Drug|pyridoxine|
12084725|NCT00004734|Drug|cyanocobalamin|
12084726|NCT00004734|Drug|folic acid multivitamin|
12084727|NCT00004733|Drug|levodopa|
12084728|NCT00004732|Procedure|Carotid Endarterectomy (CEA)|CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
12084729|NCT00004732|Device|Carotid Artery Stenting (CAS)|CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.
12084730|NCT00004731|Drug|Coenzyme Q10|
12084731|NCT00004730|Drug|magnesium sulfate|
12084732|NCT00004729|Behavioral|Ketogenic diet|
12084733|NCT00004728|Drug|Warfarin|
12084734|NCT00004728|Drug|Aspirin|
12084735|NCT00004727|Drug|aspirin|
12084736|NCT00004727|Drug|ticlopidine|
12084737|NCT00004941|Drug|monoclonal antibody cA2|
12084738|NCT00004940|Drug|cysteine hydrochloride|
12084739|NCT00004939|Drug|,4-diaminopyridine|
12084740|NCT00004938|Drug|fluconazole|
12084741|NCT00004844|Procedure|tissue implantation|
12084742|NCT00004843|Procedure|parathyroidectomy|Standard parathyroidectomy with a bilateral approach
12084743|NCT00004843|Other|Observation|Usual care
12084744|NCT00004842|Drug|budesonide|Oral budesonide, 9 mg daily was administered for 1 year
12084745|NCT00004840|Drug|thyrotropin-releasing hormone|
12084746|NCT00004838|Drug|succimer|
12084747|NCT00004834|Drug|imipramine|
12084748|NCT00004834|Behavioral|cognitive-behavioral therapy|
12084749|NCT00004833|Drug|Immune globulin|
12084750|NCT00004832|Drug|3,4-diaminopyridine|
12084751|NCT00004831|Drug|cysteine hydrochloride|
12084752|NCT00004829|Drug|tobramycin|
12084753|NCT00004828|Drug|liothyronine I 131|
12084754|NCT00004827|Drug|docosahexaenoic acid|
12084755|NCT00004826|Drug|clozapine|
12084756|NCT00004825|Drug|recombinant human insulin-like growth factor I|
12084757|NCT00004817|Drug|phenytoin|
12084758|NCT00004817|Drug|valproate sodium|
12084759|NCT00004816|Drug|monoclonal antibody M-T412|
12084760|NCT00004815|Drug|growth hormone|
12084761|NCT00004814|Drug|copolymer 1|
12084762|NCT00004812|Behavioral|Exercise|
12084763|NCT00004811|Drug|itraconazole|
12084764|NCT00004810|Drug|-aminosalicylic acid|
12084765|NCT00004809|Procedure|gene therapy|
12084766|NCT00004808|Drug|fluconazole|
12084767|NCT00004807|Drug|dextromethorphan|
12084768|NCT00004807|Drug|topiramate|
12084769|NCT00004807|Drug|Donepezil|
12084770|NCT00004806|Genetic|Cystic fibrosis transmembrane conductance regulator|
12084771|NCT00004805|Behavioral|CPR instruction|
12084772|NCT00004804|Drug|interferon alfa|
12084773|NCT00004802|Drug|dichlorphenamide|
12084774|NCT00004801|Drug|monoclonal factor IX replacement therapy|
12084775|NCT00004800|Biological|diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis|
12084776|NCT00004800|Biological|diphtheria-tetanus vaccine|
12084777|NCT00004799|Biological|whole-cell pertussis vaccine|
12084778|NCT00004799|Biological|diphtheria-tetanus vaccine|
12084779|NCT00004797|Drug|fructose|
12084780|NCT00004797|Drug|placebo|
12084781|NCT00004796|Drug|lactulose|
12084782|NCT00004795|Drug|dehydroepiandrosterone|
12084783|NCT00004794|Drug|cidofovir|
12084784|NCT00004789|Drug|heme arginate|
12084785|NCT00004789|Drug|tin mesoporphyrin|
12084786|NCT00004787|Drug|filgrastim|
12084787|NCT00004786|Drug|iloprost|
12084788|NCT00004785|Drug|dexamethasone|
12084789|NCT00004785|Drug|methylprednisolone|
12084790|NCT00004784|Drug|methotrexate|
12084791|NCT00004784|Drug|ursodiol|
12084792|NCT00004779|Genetic|Ad5-CB-CFTR|
12084793|NCT00004778|Drug|betamethasone|
12084794|NCT00004778|Drug|dexamethasone|
12084795|NCT00004778|Drug|thyrotropin-releasing hormone|
12084796|NCT00004776|Drug|topiramate|
12084797|NCT00004772|Drug|Immune globulin|
12084798|NCT00004771|Drug|leuprolide|
12084799|NCT00004771|Drug|testosterone|
12084800|NCT00004770|Drug|thioctic acid|
12084801|NCT00004767|Drug|Sodium Benzoate|
12084802|NCT00004767|Drug|Sodium Phenylacetate|
12084803|NCT00004767|Drug|Sodium Phenylbutyrate|
12084804|NCT00004767|Behavioral|Dietary Intervention|
12084805|NCT00004763|Drug|leuprolide|
12084806|NCT00004763|Drug|Ethinyl estradiol/norethindrone|
12084807|NCT00004762|Drug|cladribine|
12084808|NCT00004760|Behavioral|Exercise|
12084809|NCT00004759|Drug|methylprednisolone|
12084810|NCT00004759|Drug|tirilazad|
12084811|NCT00004758|Drug|carbamazepine|
12084812|NCT00004758|Drug|corticotropin|
12084813|NCT00004758|Drug|nitrazepam|
12084814|NCT00004758|Drug|pyridoxine|
12084815|NCT00004758|Drug|valproic acid|
12084816|NCT00004758|Procedure|Surgery|
12084824|NCT00004751|Procedure|Physical therapy|
12084825|NCT00004748|Drug|colchicine|
12084826|NCT00004748|Drug|methotrexate|
12084827|NCT00004748|Drug|ursodiol|
12084828|NCT00004747|Drug|mucoid exopolysaccharide P. aeruginosa immune globulin IV|
12084829|NCT00004744|Drug|immune globulin|
12084830|NCT00004740|Drug|isoniazid|
12084831|NCT00004705|Drug|amiloride|
12084832|NCT00004705|Drug|uridine|
12084833|NCT00004700|Drug|insulin-like growth factor I|
12084834|NCT00004699|Drug|insulin-like growth factor I|
12084835|NCT00004697|Drug|choline chloride|
12084836|NCT00004696|Drug|morphine|
12084837|NCT00004695|Drug|PEG-interleukin-2|
12084838|NCT00004694|Drug|heparin|
12084839|NCT00004690|Drug|monolaurin cream|
12084840|NCT00004689|Drug|amithiozone|
12084841|NCT00004689|Drug|clarithromycin|
12084842|NCT00004689|Drug|ethambutol|
12084843|NCT00004689|Drug|rifampin|
12084844|NCT00004689|Drug|streptomycin|
12084845|NCT00004688|Drug|carmustine|
12084846|NCT00004688|Drug|mercaptopurine|
12084847|NCT00004688|Drug|streptozocin|
12084848|NCT00004686|Drug|methotrexate|
12084849|NCT00004686|Drug|prednisone|
12084850|NCT00004685|Drug|albuterol|
12084851|NCT00004682|Drug|immune globulin|
12084852|NCT00004670|Procedure|pallidotomy|
12084853|NCT00004669|Drug|hydrocortisone|
12084854|NCT00004667|Drug|von Willebrand factor|
12084855|NCT00004665|Drug|dehydroepiandrosterone|
12084856|NCT00004664|Drug|megestrol|
12084857|NCT00004664|Behavioral|Exercise|
12084858|NCT00004662|Drug|dehydroepiandrosterone|
12084859|NCT00004660|Radiation|Radiotherapy|
12084860|NCT00004660|Radiation|Sham treatment|
12084861|NCT00004659|Procedure|irradiation|
12084862|NCT00004659|Procedure|radiosurgery|
12084863|NCT00004658|Drug|ribose|
12084864|NCT00004658|Drug|thymidine|
12084865|NCT00004658|Drug|uridine|
12084866|NCT00004656|Procedure|Metabolic assessment with body composition evaluation|
12084867|NCT00004654|Drug|soy protein isolate|
12084868|NCT00004652|Drug|pimozide|
12084869|NCT00004650|Drug|conjugated estrogens|
12084870|NCT00004650|Drug|Medroxyprogesterone|
12084871|NCT00004647|Drug|mexiletine|
12084872|NCT00004646|Drug|prednisone|
12084873|NCT00004645|Procedure|Plasma exchange|
12084874|NCT00004644|Drug|acyclovir|
12084875|NCT00004643|Drug|cytarabine|
12084876|NCT00004642|Drug|SDZ MSL-109|
12084877|NCT00004638|Procedure|pathogenesis study|
12084878|NCT00004637|Drug|Vitamin E|
12084879|NCT00004635|Drug|Thalidomide|Thalidomide 200 mg given orally every evening at 9pm. Treatment may continue indefinitely provided that there are no dose-limiting toxicity.
12084880|NCT00004635|Drug|leuprolide acetate|Injections of leuprolide once a month for six months.
12084881|NCT00004635|Drug|goserelin|Injections of Goserelin once a month for six months.
12084882|NCT00004635|Other|Placebo|Patients will receive the placebo if they initially received thalidomide. The starting dose of placebo 200 mg (four capsules of 100-50 mg capsules) orally once daily at bedtime.
12084883|NCT00004573|Drug|ganciclovir|
12084884|NCT00004572|Procedure|Sustacal challenge|
12084885|NCT00004569|Procedure|Non-invasive technique to diagnose and quantitate sleep-disordered breathing|
12084886|NCT00004567|Drug|Mycophenolate Mofetil|
12084887|NCT00004564|Drug|Clopidogrel|
12084888|NCT00004564|Drug|Atorvastatin|
12084889|NCT00004563|Drug|Cyclophosphamide|Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
12084890|NCT00004563|Drug|Placebo|Matching gelcaps 25 mgs
12084891|NCT00004562|Drug|Beta adrenergic blockers|Participants will receive beta adrenergic blockers.
12084892|NCT00004562|Drug|Platelet inhibitors|Participants will receive platelet inhibitors.
12084893|NCT00004562|Procedure|PTCA and stents|Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.
12084894|NCT00004562|Drug|ACE Inhibitors|Participants will receive ACE inhibitors.
12084895|NCT00004561|Behavioral|exercise|
12084896|NCT00004560|Device|defibrillator|
12084897|NCT00004559|Behavioral|dietary polyunsaturated fatty acid|
12084898|NCT00004558|Behavioral|dietary n-3 polyunsaturated fatty acids|
12084899|NCT00004554|Drug|naltrexone (Revia)|100mg/day
12084900|NCT00004554|Drug|sertraline (Zoloft)|200mg/day
12084901|NCT00004554|Drug|Placebo|Placebo
12084902|NCT00004553|Procedure|Electromyography|
12084903|NCT00004552|Drug|acamprosate (Campral)|
12084904|NCT00004551|Drug|nicotine replacement patch|
12084905|NCT00004551|Behavioral|mood management|
12084906|NCT00004549|Procedure|Magnetic resonance imaging|
12084907|NCT00004547|Procedure|Surgery|Patients will undergo cytoreductive surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected.
12084908|NCT00004547|Procedure|Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin|
12084909|NCT00004547|Drug|Postoperative dwell with paclitaxel and 5-FU|Intraperitoneal dwell chemotherapy with a combination of 5-FU and Paclitaxel will be delivered in the early postoperative period (day 7 today 12 after surgery). Patients will be premedicated with hydrocortisone (100 mg/intravenous push (i.v.p.)), diphenhydramine (50 mg i.v.p.) and ranitidine (50 mg i.v.p.) 30 minutes prior to delivering intraperitoneal chemotherapy. One liter of normal saline will be infused containing 5-FU (800 mg/M^2) and 1 L of normal saline containing paclitaxel (125 mg/M^2) will be infused over 60 minutes. The chemotherapy solution will be left in the abdominal cavity permanently for slow absorption.
12084910|NCT00004533|Drug|Adeno-associated virus-CFTR vector|
12084911|NCT00000436|Behavioral|Self-efficacy and muscle strength training|
12084912|NCT00000436|Procedure|High-intensity strength training|
12084913|NCT00001984|Drug|Alemtuzumab and DSG|Alemtuzumab was administered intravenously at 0.3 mg/kg/dose over 3 hr. Patients received one dose on each of days -1,+1,+3 and +5 relative to transplantation (total dose 1.2 mg/kg). Methylprednisolone was given prior to each dose to limit the cytokine release: 500 mg prior to dose 1, 125 mg prior to dose 2, and 60 mg prior to doses 3 and 4. Deoxyspergualin was dosed as follows. The first two patients received 4 mg/kg as a loading dose on the day of transplant and 2.5 mg/kg daily for 13 additional days (14 days of treatment; 36.5 mg/kg total dose). The next three patients received the same dosing regimen but it was initiated on postoperative day 12 to coincide with the resurgence of monocytes on days 12- 25.
12084914|NCT00000435|Drug|dnaJ peptide|dnaJP1 was taken in pill form at 25mg/day for 6 months
12084915|NCT00000435|Drug|None-placebo|placebo was taken in pill form at 25mg/day for 6 months
12084916|NCT00000434|Behavioral|Fit and Strong!|Fit and Strong! is a multi-component exercise and health education program that includes flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.
12084917|NCT00001972|Drug|15 O Water|
12084918|NCT00001967|Drug|HAART|
12084919|NCT00001964|Drug|Cyclosporine A|Cyclosporine A
12084920|NCT00001964|Drug|ATG|ATG
12084921|NCT00001964|Drug|MMF|MMF
12084922|NCT00001962|Drug|Daclizumab|Daclizumab, 1mg/kg of body weight, every 2 weeks for a total of 5 infusions.
12084923|NCT00001961|Procedure|MRI|
12084924|NCT00001960|Device|Pacemaker therapy|
12084925|NCT00001959|Drug|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
12084926|NCT00001958|Drug|Hydroxyurea|
12084927|NCT00001956|Procedure|Blood draw|
12084928|NCT00001956|Procedure|Oral surgery|
12084929|NCT00001956|Procedure|Tissue biopsy|
12084930|NCT00001955|Drug|Etanercept|
12084931|NCT00001955|Drug|Celecoxib|
12084932|NCT00001954|Drug|Etanercept|
12084933|NCT00001951|Drug|TMTDS|
12084934|NCT00001946|Procedure|Magnetic resonance angiography|
12084935|NCT00001941|Biological|daclizumab|
12084936|NCT00000433|Drug|Anti-Tumor Necrosis Factor|
12084937|NCT00000432|Behavioral|Education about disease prevention|
12084938|NCT00000431|Drug|PDGF-B/Ad5|This is a dose finding study to evaluate the safety of a single injection of PDGF dna in an adenoviral vector.
12084939|NCT00000430|Drug|Alendronate|
12084940|NCT00000430|Drug|Estrogen/progestin therapy|
12084941|NCT00000429|Drug|Calcium carbonate|
12084942|NCT00000428|Drug|Amitriptyline|Amitriptyline 25 mg po
12084943|NCT00000428|Drug|Amitriptyline plus Fluoxitine|Amitriptyline 25 mg po plus Fluoxitine 20 mg po
12084944|NCT00000427|Drug|Parathyroid hormone|
12084945|NCT00000427|Drug|Alendronate|
12084946|NCT00000111|Procedure|Oral mucosal graft|
12084947|NCT00000110|Procedure|magnetic resonance spectroscopy|
12084948|NCT00000110|Drug|dietary fat|
12084949|NCT00000108|Behavioral|Exercise|
12084950|NCT00000106|Device|Whole body hyperthermia unit|
12084951|NCT00000393|Drug|Peptide T|
12084952|NCT00000392|Drug|Peptide T|
12084953|NCT00000392|Drug|Placebo|
12084954|NCT00000391|Drug|Peptide T|
12084955|NCT00000390|Drug|Imipramine hydrochloride|
12084956|NCT00001934|Drug|Zenapax|
12084957|NCT00001933|Drug|Nefiracetam|
12084958|NCT00001926|Drug|O15|
12084959|NCT00001926|Device|Cadwell rTMS|
12084960|NCT00001925|Drug|Alcohol|
12084961|NCT00001923|Procedure|Transcranial magnetic stimulation|
12084962|NCT00001919|Drug|Hypericum (LI-160)|
12084963|NCT00001917|Drug|O15|
12084964|NCT00001917|Drug|[F-18] FP-TZTP|
12084965|NCT00001911|Drug|Interleukin-12|
12084966|NCT00001905|Drug|Interferon gamma|
12084967|NCT00001901|Drug|Etanercept|
12084968|NCT00001895|Drug|FDG|
12084969|NCT00001895|Drug|NH(3)|
12084970|NCT00001894|Procedure|pacemaker implantation|
12084971|NCT00001894|Procedure|percutaneous transluminal septal ablation (PTSA)|
12084972|NCT00001893|Drug|TNFR:Fc|
12084973|NCT00001880|Drug|methotrexate|CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given
12084974|NCT00001880|Drug|cyclosporin|CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given
12084975|NCT00001877|Drug|Pentoxifylline|
12084976|NCT00001873|Device|Isolex 300i plus MoAbs|
12084977|NCT00001870|Drug|Acetylcholine|
12084978|NCT00001865|Drug|Daclizumab|
12084979|NCT00001863|Drug|Leflunomide|
12084980|NCT00001862|Drug|Enbrel|
12084981|NCT00001860|Drug|Sandostatin LAR Depot versus transsphenoidal surgery|
12084982|NCT00001854|Drug|Ribavirin|
12084983|NCT00001849|Drug|Pentetreotide|Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5
12084984|NCT00001849|Drug|18F-DOPA|F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography.
12084985|NCT00001848|Drug|Raloxifene|
12084986|NCT00001842|Drug|Granulocyte colony-stimulating factor|
12084987|NCT00001842|Drug|Dexamethasone|
12084988|NCT00001835|Drug|Oxaliplatin|
12085058|NCT00001644|Procedure|Lymph node biospy|
12085059|NCT00001644|Procedure|Leukapheresis|
12085060|NCT00001637|Procedure|Blood cell transplantation|
12085061|NCT00001631|Procedure|Magnetic resonance imaging|
12085062|NCT00001630|Device|Isolex 300i|
12085063|NCT00001626|Drug|antithymocyte globulin|antithymocyte globulin
12085064|NCT00001626|Drug|cyclophosphamide|cyclophosphamide
12085065|NCT00001626|Drug|cyclosporine|cyclosporine
12084989|NCT00001832|Drug|gp100:209-217 (210M)|"gp100 = gp100:209-217(210M) peptide - 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus gp100:209-217(210M) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
~MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections."
12084990|NCT00001832|Drug|Montanide ISA-51|MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
12084991|NCT00001832|Drug|IL-2|"125,000 IU/kg dose intravenous for 5 days for 6 weeks with 2 days rest per week.
~720,000 IU/kg intravenous every 8 hours for a maximum of 12 doses."
12084992|NCT00001832|Drug|MART-1:26-35(27L)|MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
12084993|NCT00001832|Biological|Abl cells|Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days Abl cells IA = Lymphocytes 10^9-10^11 IA over 30 minutes on day 0, repeated in 14 to 21 days
12084994|NCT00001832|Drug|Fludarabine|5x25 mg/m^2 intravenous
12084995|NCT00001832|Drug|Cyclophosphamide|2x30 mg/kg, 2x60 mg/kg intravenous
12084996|NCT00001832|Biological|GCSF (Growth colony stimulating factor)|Beginning on day 1 or 2, GCSF will be administered subcutaneously at a dose of 5mcg/kg/day (not to exceed 300 mcg/day. Filgrastim administration will continue daily until neutrophil count > 1.0 x10^9/L x 3 days or > 5.0 x10^9/L.
12084997|NCT00001832|Procedure|Apheresis|
12084998|NCT00001830|Drug|Th2 cells in allo HSCTT|
12084999|NCT00001830|Drug|Th2 Cells|
12085000|NCT00001827|Biological|aldesleukin|
12085001|NCT00001827|Biological|incomplete Freund's adjuvant|
12085002|NCT00001827|Biological|p53 peptide vaccine|
12085003|NCT00001827|Biological|sargramostim|
12085004|NCT00001827|Biological|therapeutic autologous dendritic cells|
12085005|NCT00001827|Procedure|in vitro-treated peripheral blood stem cell transplantation|
12085006|NCT00001806|Other|Genetic Education and Counseling|Group Education and Counseling
12085007|NCT00001806|Other|Genetic Education and Counseling|Individual Education and Counlseing
12085008|NCT00001785|Drug|Recombinant human interferon beta-1a|
12085009|NCT00001784|Drug|Mexiletine|
12085010|NCT00001783|Drug|0-15 Water|
12085011|NCT00001781|Drug|CGP 77116|
12085012|NCT00001776|Device|Cadwell Rapid Rate Magnetic Stimulator|
12085013|NCT00001766|Drug|Amprenavir, Efavirenz, Abacavir, Nelfinavir, Ritonavir|
12085014|NCT00001765|Device|Nexell Isolex with T-cell Depletion|
12085015|NCT00001765|Device|Baxter isolex 300i|
12085016|NCT00001764|Drug|Mycophenolate Mofetil|
12085017|NCT00001758|Drug|Abacavir|
12085018|NCT00001758|Drug|Amprenavir|
12085019|NCT00001758|Drug|Efavirenz|
12085020|NCT00001750|Drug|Stemgen|
12085021|NCT00001749|Drug|Antithymocyte globulin|
12085022|NCT00001749|Drug|Cyclosporine|
12085023|NCT00001741|Drug|Losartan|
12085024|NCT00001737|Drug|Cyclosporin A Implant|
12085025|NCT00001729|Drug|Ribavirin|
12085026|NCT00001728|Drug|Fosamax (Alendronate)|
12085027|NCT00001725|Drug|Dextromethorphan|
12085028|NCT00001724|Drug|Flurbiprofen|
12085029|NCT00001723|Drug|Orlistat|Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
12085030|NCT00001723|Drug|Placebo|Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
12085031|NCT00001720|Drug|Alendronate|
12085032|NCT00001716|Drug|Nitric Oxide|
12085033|NCT00001716|Drug|Nitroglycerin|
12085034|NCT00001713|Drug|Recombinant Tissue Plasminogen Activator|
12085035|NCT00001713|Drug|Heparin|
12085036|NCT00001713|Drug|Warfarin|
12085037|NCT00001703|Biological|incomplete Freund's adjuvant|0.7 ml of ISA-51 (Montanide ISA-51 adjuvant, incomplete Freund's adjuvant) will be mixed with peptide alone and injected subcutaneously every four weeks for a total of four vaccinations.
12085038|NCT00001703|Biological|von Hippel-Lindau peptide vaccine|1000 micrograms administered subcutaneously every four weeks for a total of four vaccinations.
12085039|NCT00001698|Drug|Ketorolac Rinse|
12085040|NCT00001693|Drug|Celecoxib (SC-58635)|
12085041|NCT00001689|Drug|Vincristine|
12085042|NCT00001683|Drug|COL-3|
12085043|NCT00001676|Drug|SQ Fludarabine|
12085044|NCT00001666|Device|Cadwell High-Speed Magnetoelectric Stimulator|
12085045|NCT00001666|Device|Magpro High-Speed Magnetoelectric Stimulator|
12085046|NCT00001663|Device|Magstim Super Rapid Stimulator|
12085047|NCT00001662|Drug|CX516 (Ampalex)|
12085048|NCT00001656|Drug|Olanzapine|tablet; 5-20mg/day; 8 weeks
12085049|NCT00001656|Drug|Clozapine|tablet; 12.5-900mg/day; 8 weeks
12085050|NCT00001651|Other|[6,6-2H2]-glucose|[6,6-2H2]-glucose will be administered as a continuous IV infusion for one to five days.
12085051|NCT00001649|Drug|Valaciclovir|
12085052|NCT00001647|Procedure|White blood cell infusion|
12085053|NCT00001644|Drug|Indinavir|
12085054|NCT00001644|Drug|Zidovudine|
12085055|NCT00001644|Drug|Lamivudine|
12085056|NCT00001644|Drug|Nevirapine|
12085057|NCT00001644|Procedure|Blood testing|
12085066|NCT00001623|Procedure|Allogeneic Bone Marrow Transplant|
12085067|NCT00001601|Procedure|Electrocardiogram|
12085068|NCT00001601|Procedure|Biopsies|
12085069|NCT00001601|Procedure|Diagnostic imaging|
12085070|NCT00001599|Drug|Thalidomide|
12085071|NCT00001598|Drug|Dehydroepiandrosterone|
12085072|NCT00001596|Drug|Pirfenidone|Treatment with pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
12085073|NCT00001596|Drug|Placebo|Placebo (3 pills), three times daily.
12085074|NCT00001586|Biological|Rituximab|Rituxan
12085075|NCT00001586|Drug|Fludarabine phosphate|Fludara
12085076|NCT00001586|Other|Leukemic or stroma cells|Patients are eligible to donate cells for the purpose of analyzing leukemic cells. Cells can be donated by apheresis (e.g. 60-90 minute intravenous technique), lymph node biopsy (e.g. 3 biopsy/excision of lymph nodes)bone marrow biopsy (e.g. 2-4 separate bone marrow biopsies), and bone marrow aspiration (e.g. 3 to 5cc of marrow per aspirate).
12085077|NCT00001576|Drug|Melphalan|
12085078|NCT00001576|Drug|Floxuridine|
12085079|NCT00001576|Drug|Leucovorin|
12085080|NCT00001575|Biological|Y-90 Humanized Anti-Tac|10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
12085081|NCT00001575|Drug|Calcium-DTPA|Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
12085082|NCT00001572|Drug|Id-KLH Vaccine|
12085083|NCT00001572|Drug|QS-21 (Stimulation-QS-21) Drug|
12085084|NCT00001569|Drug|Cisplatin|
12085085|NCT00001569|Drug|Paclitaxel|
12085086|NCT00001569|Drug|5-FU|
12085087|NCT00001568|Drug|2-Fluoro-2-deoxyglucose|
12085088|NCT00001567|Drug|Roferon-A|
12085089|NCT00001566|Biological|therapeutic autologous dendritic cells|3 syringes containing 1 x 10^6peptide pulsed dendritic cells
12085090|NCT00001566|Drug|indinavir sulfate|Oral dose, 350 mg/m^2 administered every 8 hours. Maximum dose is 800 mg every 8 hours.
12085091|NCT00001566|Procedure|peripheral blood stem cell transplantation|Harvested autologous T cells, minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
12085092|NCT00001564|Drug|EF-1 Peptide|
12085093|NCT00001564|Drug|EF-2 Peptide|
12085094|NCT00001564|Drug|PXFK Peptide|
12085095|NCT00001564|Drug|E7 Peptide|
12085096|NCT00001564|Drug|IL-2|
12085097|NCT00001564|Drug|IL-4|
12085098|NCT00001564|Drug|GM-CSF|
12085099|NCT00001564|Drug|CD40 Ligand|
12085100|NCT00001563|Biological|Filgrastim|Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.
12085101|NCT00001563|Biological|Rituximab|EPOCH-R every 3 weeks for up to 6 cycle
12085102|NCT00001563|Drug|EPOCH|EPOCH-R every 3 weeks for up to 6 cycle
12085103|NCT00001561|Drug|Myeloma Immunoglobulin Idiotype Vaccine-KLH|
12085104|NCT00001561|Drug|GM-CSF|
12085105|NCT00001550|Drug|IVIg|
12085106|NCT00001545|Device|Magstim Super Rapid Magnetic Stimulator|
12085107|NCT00001545|Device|Cadwell MES-10|
12085108|NCT00001535|Drug|Syngeneic Lymphocytes (CD4+) Cultured with OKT3 (Ortho) and Interleukin-2 (Chiro|
12085109|NCT00001534|Drug|Losartan|
12085110|NCT00001532|Device|Toshibia Aquilion ONE CT|The Toshiba Aquilion ONE CT system is currently being used for studies in both general CT radiology and CT cardiac imaging. One of the unique aspects of the Aquilion ONE CT system is its ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy. In line with the evolutionary changes to CT systems, the Aquilion ONE will be upgraded with new technology that will expand its capabilities. The changes being made to the Aquilion ONE will provide enhancements to image acquisition capabilities, reduce ionizing radiation dose, and improve subject access to the system. All of these features assist in enhancing the safety of the currently installed Aquilion ONE CT system.
12085111|NCT00001526|Drug|Daclizumab (Zenapax)|
12085112|NCT00001524|Drug|Thalidomide|
12085113|NCT00001521|Drug|Flutamide|Non steroidal antiandrogen that prevents the action of androgens by blocking receptor sites in target tissue. It may also produce changes in testosterone and estradiol
12085114|NCT00001521|Drug|Letrozole|Armomatase inhibitor.
12085115|NCT00001521|Drug|Hydrocortisone|reduced hydrocortisone dose can normalize the growth and adult stature of children with congenital adrenal hyperplasia
12085116|NCT00001521|Drug|Fludrocortisone|Since hydrocortisone dosage will be reduced , some patients may develop symptoms or signs of adrenal insufficiency. Patients will continue to receive an optimal fludrocortisone dose
12085117|NCT00001515|Device|virtual bronchoscopy|
12085118|NCT00001512|Drug|Id-KLH Vaccine|
12085119|NCT00001512|Drug|GM-CSF|
12085120|NCT00001507|Drug|Monoclonal Antibody 3A1|
12085121|NCT00001507|Drug|Monoclonal Antibody 95-5-49|
12085122|NCT00001507|Drug|Monoclonal Antibody 95-6-22|
12085123|NCT00001507|Device|Baxter Isolex 3001 Stem Cell Selection System|
12085124|NCT00001507|Device|Ceprate SC|
12085125|NCT00001504|Drug|9-cis-Retinoic Acid|
12085126|NCT00001487|Drug|Dehydroepiandrosterone|
12085127|NCT00001483|Drug|buproprion (Wellbutrin)|
12085128|NCT00001483|Drug|sertraline (Zoloft)|
12085129|NCT00001483|Drug|venlafaxine (Effexor)|
12085130|NCT00001481|Drug|Estradiol, Progesterone|To determine whether women who have had a previous episode of postpartum major affective episode will experience differential mood and behavioral effects compared with controls and to determine whether
12085131|NCT00001481|Other|Placebo|To determine whether women who have had a previous episode of postpartum major affective episode will experience differential mood and behavioral effects compared with controls
12085132|NCT00001476|Drug|Gene Therapy Method for CGD|
12085133|NCT00001476|Device|Isolex 300i Magnetic Cell Selector|
12085134|NCT00001475|Drug|IL-2 plus Anti-TNF or Thalidomide|
12085135|NCT00001474|Drug|Interleukin-2|
12085194|NCT00001262|Drug|Copper Histidine|
12085195|NCT00001261|Drug|Gamma Globulin|
12085136|NCT00001465|Device|Toshibia Aquilion One CT|The Toshiba Aquilion ONE CT system is currently being used for studies in both general CT radiology and CT cardiac imaging. One of the unique aspects of the Aquilion ONE CT system is its ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy. In line with the evolutionary changes to CT systems, the Aquilion ONE will be upgraded with new technology that will expand its capabilities. The changes being made to the Aquilion ONE will provide enhancements to image acquisition capabilities, reduce ionizing radiation dose, and improve subject access to the system. All of these features assist in enhancing the safety of the currently installed Aquilion ONE CT system.
12085137|NCT00001460|Behavioral|inpatient evaluation and management|
12085138|NCT00001457|Drug|Lamivudine|
12085139|NCT00001444|Drug|7-hydroxystaurosporine (UCN-01)|
12085140|NCT00001442|Drug|paclitaxel concurrent with radiation therapy|
12085141|NCT00001440|Procedure|Autologous T cells|
12085142|NCT00001440|Drug|Interleukin-2|
12085143|NCT00001430|Procedure|PBSC|
12085144|NCT00001430|Drug|IL-2|
12085145|NCT00001430|Drug|EPOCH II|
12085146|NCT00001426|Drug|Cyclophosphamide|
12085147|NCT00001426|Drug|Paclitaxel|
12085148|NCT00001426|Drug|Cisplatin|
12085149|NCT00001426|Drug|G-CSF|
12085150|NCT00001410|Drug|Lysodase|
12085151|NCT00001409|Drug|Interleukin-2|
12085152|NCT00001407|Drug|Interferon Gamma|
12085153|NCT00001399|Drug|Transduced CD34+ Cells|
12085154|NCT00001398|Drug|Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF)|
12085155|NCT00001396|Device|Paragon Pacemaker|
12085156|NCT00001386|Drug|PCLUS 3-18 MN|
12085157|NCT00001386|Drug|PCLUS 6.1 MN|
12085158|NCT00001379|Biological|Interferon|For LYG Grade 1 and 2: Interferon starting at 7.5 million Units subQ 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Patients continue taking interferon for 1 year beyond CR.
12085159|NCT00001379|Drug|Rituxan and EPOCH|For LYG Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituxan) every 3 weeks for 6 cycles.
12085160|NCT00001368|Procedure|cytokine and leukocyte activation profile|
12085161|NCT00001359|Drug|Penicillin or Placebo|
12085162|NCT00001357|Drug|Interleukin-2|
12085163|NCT00001354|Drug|Interleukin-2/Zidovudine (AZT)|
12085164|NCT00001353|Drug|Genetically Marked Syngeneic T Lymphocytes|
12085165|NCT00001343|Drug|Humatrope|
12085166|NCT00001343|Drug|Oxandrolone|
12085167|NCT00001339|Drug|doxorubicin, vincristine, and etoposide with mitotane|
12085168|NCT00001337|Drug|EPOCH|Combination chemotherapy given with Rituximab (EPOCH-R) IV every 3 weeks for 6 cycles.
12085169|NCT00001337|Biological|Rituximab|Rituximab given on Day 1 of combination chemotherapy (EPOCH-R) every 3 weeks for 6 cycles.
12085170|NCT00001335|Drug|ADR-529|
12085171|NCT00001335|Drug|Topotecan|
12085172|NCT00001335|Drug|G-CSF|
12085173|NCT00001328|Drug|Cytovene (Ganciclovir Sodium)|
12085174|NCT00001328|Device|G1TKSVNa.53 Producer Cell Line|
12085175|NCT00001325|Drug|18 FDG|
12085176|NCT00001322|Drug|Leuprolide Acetate 3.75|Each woman will be administered Lupron for two months only.
12085177|NCT00001322|Drug|Estrogel|After the first month of Lupron treatment when ovarian suppression has been achieved, we will administer 2-3 applications (approximately 6.0 9.0 mg estradiol gel (open label)) once a day for four weeks.
12085178|NCT00001322|Drug|Progesterone|After the four weeks of estradiol treatment, all women will receive one week of progesterone suppositories (200 mg twice a day) to precipitate a progesterone withdrawal-induced menses.
12085179|NCT00001309|Other|Vitamin C|Outpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection.
12085180|NCT00001307|Drug|Oxygen-15 Water|
12085181|NCT00001307|Drug|Capsaicin|
12085182|NCT00001305|Drug|Humatrope|Patients receive a subcutaneous injection.
12085183|NCT00001304|Drug|Synthetic Human Parathyroid Hormone 1-34|twice daily subcutaneous injections
12085184|NCT00001304|Drug|Calcitriol & Calcium|Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation
12085185|NCT00001303|Drug|Reference Endotoxin|
12085186|NCT00001303|Drug|Inhaled Nitric Oxide|
12085187|NCT00001302|Drug|PSC 833|
12085188|NCT00001288|Drug|15 O Water|
12085189|NCT00001288|Drug|FDG|
12085190|NCT00001282|Drug|Zidovudine (AZT) & Interleukin-2 (IL2)|
12085191|NCT00001277|Drug|68Ga-Dotatate|-To compare the efficacy of 68Ga- Dotatate PET/CT scan versus 18FDOPA PET/CT, MRI and CT scan in detecting known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors -To evaluate 68Gallium-Dotatate versus 18F-DOPA PET /CT uptake in NETs and its association with tumor differentiation. (2)To determine whether 68Gallium- Dotatate and/or 18FDOPA PET/CT uptake value is predictive of tumor growth and/or disease progression and of its differentiation state.
12085192|NCT00001277|Drug|18F-DOPA|-To compare the efficacy of 68Ga- Dotatate PET/CT scan versus 18FDOPA PET/CT, MRI and CT scan in detecting known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors -To evaluate 68Gallium-Dotatate versus 18F-DOPA PET /CT uptake in NETs and its association with tumor differentiation -To determine whether 68Gallium-Dotatate and/or 18FDOPA PET/CT uptake value is predictive of tumor growth and/or disease progression and of its differentiation state.
12085193|NCT00001266|Drug|Suramin|
12085196|NCT00001259|Drug|Leuprolide|3.75mg IMQM
12085197|NCT00001259|Drug|Estradiol Patches|0.1 mg/day of estradiol via skin patch (Estraderm) for a period of five weeks.
12085198|NCT00001259|Drug|Progesterone|progesterone suppositories (200 mgs twice daily)
12085199|NCT00001256|Drug|prednisone and methotrexate|
12085200|NCT00001255|Drug|ADA PBSC|
12085201|NCT00001255|Drug|ADA Umbilical Cord Blood Cells|
12085202|NCT00001255|Drug|Transduced Lymphocytes|
12085203|NCT00001253|Behavioral|cognitive tests and scales|
12085204|NCT00001251|Drug|Mafosfamide|
12085205|NCT00001250|Drug|preoperative dose intense chemotherapy (FLAC/G-CSF)|
12085206|NCT00001248|Device|MRI|MRI evaluations of brain, spinal cord, or optic nerves may be performed at field strengths of 1.5T, 3T, and/or 7T, under conditions designated by the FDA as constituting nonsignificant risk. Unless specifically designated below, MRI scans are performed on FDA- approved scanners with approved radiofrequency coils, and their use conforms to the corresponding FDA labels.
12085207|NCT00001248|Device|Coils|MRI evaluations of brain, spinal cord, or optic nerves may be performed at field strengths of 1.5T, 3T, and/or 7T, under conditions designated by the FDA as constituting nonsignificant risk. Unless specifically designated below, MRI scans are performed on FDA- approved scanners with approved radiofrequency coils, and their use conforms to the corresponding FDA labels.
12085208|NCT00001234|Genetic|human glucocerebrosidase cDNA|
12085209|NCT00001228|Drug|Interferon|
12085210|NCT00001221|Drug|Growth Hormone (Humatrope)|
12085211|NCT00001213|Drug|Cysteamine|
12085212|NCT00001212|Drug|prednisone|
12085213|NCT00001212|Drug|cyclophosphamide|
12085214|NCT00001212|Drug|cyclosporin A|
12085215|NCT00001202|Drug|Spironolactone|
12085216|NCT00001202|Drug|Testolactone|
12085217|NCT00001202|Drug|Deslorelin|
12085218|NCT00001197|Drug|Hydroxyurea|
12085219|NCT00001191|Drug|Pantoprazole|
12085220|NCT00001191|Drug|Omeprazole|
12085221|NCT00001182|Procedure|current standard of care treatments|
12085222|NCT00001181|Drug|Testolactone|
12085223|NCT00001180|Drug|Ovine Corticotropin-Releasing Hormone (oCRH)|
12085224|NCT00001165|Drug|combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin|
12085225|NCT00001155|Drug|cyclophosphamide|
12085226|NCT00001151|Drug|1,25-Dihydroxycholecalciferol|Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day. All patients in this study received very high doses or 5-20 ug per day.
12085227|NCT00001146|Drug|Ethyl Eicosapentaenoic Acid|
12085228|NCT00001146|Drug|OmegaBrite|
12085229|NCT00001145|Drug|Bacteriophage|
12085230|NCT00001145|Drug|rhuCD40L|
12085231|NCT00001145|Drug|KLH|
12085232|NCT00001144|Drug|Modified bone marrow stem cell transplantation|
12085233|NCT00000426|Drug|Calcium supplement|
12085234|NCT00000425|Drug|Nonsteroidal anti-inflammatory drugs (NSAIDs)|
12085235|NCT00000425|Drug|Acetaminophen|
12085236|NCT00000424|Procedure|Tidal lavage vs. sham lavage of the knee|
12085237|NCT00000423|Behavioral|Social support group|
12085238|NCT00000423|Behavioral|Social support and education group|
12085239|NCT00000422|Behavioral|Cognitive-behavioral psychotherapy and physical exercise|
12085240|NCT00000421|Drug|Prednisone|
12085241|NCT00000421|Drug|Placebo|
12085242|NCT00000420|Drug|Ortho-Novum 777|
12085243|NCT00000419|Drug|Premarin and Provera|
12085244|NCT00000418|Procedure|Psychosocial intervention|
12085245|NCT00000417|Procedure|Counseling intervention|
12085246|NCT00000417|Device|Informational film|
12085247|NCT00000416|Other|Rehabilitation counseling|Provided in 2 in-person meetings and in follow-up phone calls
12085248|NCT00000415|Procedure|Physical activity|
12085249|NCT00000415|Drug|Calcium supplement|
12085250|NCT00000414|Behavioral|Arthritis Self-Management Program|
12085251|NCT00000414|Behavioral|SMART Program|
12085252|NCT00000413|Behavioral|Psychoeducational program|
12085253|NCT00000412|Drug|Alendronate|
12085254|NCT00000412|Drug|Calcitriol|
12085255|NCT00000412|Drug|Placebo Alendronate|
12085256|NCT00000412|Drug|Placebo Calcitriol|
12085257|NCT00000411|Procedure|Decompressive laminectomy|Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis.
12085258|NCT00000411|Other|Non-surgical treatments|Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
12085259|NCT00000410|Procedure|Diskectomy|The surgeon will leave the nerve root freely mobile and undamaged following the procedure. During the procedure, the surgeon may consider using loop magnification or a microscope. The surgical incision will be midline and, after reflecting the paraspinous muscles, the interlaminar level will be identified and entered. The nerve root will be clearly identified and mobilized and then gently retracted to prepare for the discectomy. Removal of the medial border of the superior facet may, in some cases, be necessary in order to have a clear view of the lateral border of the involved nerve root. Following the clear view of the nerve root and mobilization, the IDH will be approached by making a small annular incision if necessary, the fragment of disc will then be removed (i.e., limited disc excision). A search of the canal will follow removal of the fragment, along with probing of the intervertebral-foramen for residual disc or bony pathology.
12085260|NCT00000410|Procedure|Non-surgical treatments|Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
12085261|NCT00000409|Procedure|Decompressive laminectomy|Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis
12085262|NCT00000409|Other|Non-surgical treatments|Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated. Any non-operative therapies other than these are accepted and collected as data.
12085337|NCT00000387|Behavioral|Self-management therapy|
12085338|NCT00000386|Behavioral|Exposure and Response Prevention|
12085263|NCT00000409|Procedure|Fusion--Instrumented|In addition to decompressive laminectomy, additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.
12085264|NCT00000409|Procedure|Fusion-Non-instrumented|additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.
12085265|NCT00000408|Procedure|Patient education evaluation|
12085266|NCT00000407|Behavioral|Vocational counseling intervention|
12085267|NCT00000407|Behavioral|Reading materials for control participants|
12085268|NCT00000407|Behavioral|Standard of care|No education or behavioral intervention
12085269|NCT00000406|Procedure|Progressive resistance exercise|
12085270|NCT00000405|Procedure|Exercise intervention|
12085271|NCT00000404|Behavioral|Patient education in self-care of knee OA|
12085272|NCT00000403|Drug|Doxycycline|
12085273|NCT00000402|Drug|Calcium|
12085274|NCT00000401|Drug|Oral bovine type II collagen|Drug can be interrupted or stopped for suspected adverse events.
12085275|NCT00000400|Drug|Human parathyroid hormone [hPTH-(1-34)]|37 mcg once daily by self-administered sc injection
12085276|NCT00000400|Drug|alendronate|70 mg/week by oral route
12085277|NCT00000399|Drug|Hormone replacement therapy|
12085278|NCT00000399|Procedure|Strength training|
12085279|NCT00000398|Behavioral|Coping skills training|
12085280|NCT00000398|Behavioral|Physical exercise training|
12085281|NCT00000398|Behavioral|Coping skills training plus physical exercise training|
12085282|NCT00000397|Behavioral|Behavioral insomnia therapy|
12085283|NCT00000396|Behavioral|Patient self-care education|
12085284|NCT00000395|Drug|Methotrexate|
12085285|NCT00000395|Dietary Supplement|Folinic acid|
12085286|NCT00000395|Dietary Supplement|Folic acid|
12085287|NCT00000394|Procedure|Acupuncture therapy|
12085288|NCT00000105|Biological|Intracel KLH Vaccine|Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
12085289|NCT00000105|Biological|Biosyn KLH|Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
12085290|NCT00000105|Drug|Montanide ISA51|Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.
12085291|NCT00000105|Biological|Tetanus toxoid|Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
12085292|NCT00000104|Procedure|ERP measures of attention and memory|
12085293|NCT00000102|Drug|Nifedipine|
12085294|NCT00000458|Drug|sertraline (Zoloft)|
12085295|NCT00000458|Behavioral|cognitive behavior therapy|
12085296|NCT00000457|Drug|bupropion (Wellbutrin)|"1 pill in the am of 150 mg of Bupropion
~1 pill (150 mg) in the AM and one in the PM for a total of 300 mg per day for subsequent 44 weeks."
12085297|NCT00000457|Drug|Placebo|placebo pill to match (look alike) the 150 mg pill of the bupropion given in the am for 3 days and then two pills (one in the morning and one at night) for the subsequent 44 mg.
12085298|NCT00000456|Drug|naltrexone (Revia)|
12085299|NCT00000456|Behavioral|cognitive behavior therapy|
12085300|NCT00000456|Behavioral|motivational enhancement therapy|
12085301|NCT00000455|Drug|naltrexone|
12085302|NCT00000454|Drug|nicotine replacement patch|
12085303|NCT00000452|Drug|naltrexone (Revia)|
12085304|NCT00000452|Behavioral|Compliance Enhancement Tech.|
12085305|NCT00000452|Behavioral|Cognitive Behavior Therapy|
12085306|NCT00000451|Drug|sertraline|16 week outpatient study
12085307|NCT00000451|Drug|naltrexone|16 week outpatient study
12085308|NCT00000450|Drug|Naltrexone Tablet|
12085309|NCT00000450|Drug|Matched Placebo Tablet|
12085310|NCT00000449|Drug|naltrexone (Revia)|
12085311|NCT00000449|Behavioral|cognitive behavioral therapy|
12085312|NCT00000449|Behavioral|cue exposure treatment|
12085313|NCT00000448|Drug|naltrexone|Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
12085314|NCT00000448|Drug|Placebo|A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.
12085315|NCT00000447|Drug|naltrexone (Revia)|
12085316|NCT00000447|Drug|nicotine replacement patch|
12085317|NCT00000446|Drug|sertraline (Zoloft)|
12085318|NCT00000445|Drug|naltrexone (Revia)|
12085319|NCT00000444|Drug|nicotine replacement patch|
12085320|NCT00000443|Drug|ondansetron (Zofran)|
12085321|NCT00000442|Drug|naltrexone (Revia)|
12085322|NCT00000441|Drug|lorazepam (Ativan)|
12085323|NCT00000441|Drug|carbamazepine (Tegretol)|
12085324|NCT00000440|Drug|naltrexone (Revia)|
12085325|NCT00000440|Drug|sertraline (Zoloft)|
12085326|NCT00000439|Drug|sodium valproate|subjects were randomized to sodium valproate vs placebo. Serum sodium valproate was monitored. This intervention was added on treatment as usual which was defined as being on lithium carbonate and also attending individual dual recovery counseling.
12085327|NCT00000438|Drug|naltrexone (Revia)|
12085328|NCT00000437|Drug|Naltrexone Tablet and Nicotine Patch|
12085329|NCT00000437|Drug|Naltrexone Tablet and Placebo Patch|
12085330|NCT00000437|Drug|Placebo Tablet and Nicotine Patch|
12085331|NCT00000437|Drug|Placebo Tablet and Placebo Patch|
12085332|NCT00000389|Drug|Fluvoxamine|
12085333|NCT00000388|Behavioral|Psychosocial treatment|
12085334|NCT00000388|Drug|Anti-ADHD medication|
12085335|NCT00000388|Behavioral|Assessment-and-Referral|
12085336|NCT00000387|Behavioral|Self-management therapy|Behavioral
12085339|NCT00000386|Behavioral|Family Treatment Program|
12085340|NCT00000386|Behavioral|Relaxation Training|
12085341|NCT00000386|Behavioral|Behavior therapy|
12085342|NCT00000386|Behavioral|Family Counseling|
12085343|NCT00000385|Drug|Lithium|Lithium 600 mg to 2700 mg per day
12085344|NCT00000385|Drug|Placebo|Matching placebo
12085345|NCT00000384|Behavioral|Cognitive Behavior Therapy|
12085346|NCT00000384|Behavioral|Educational Support|
12085347|NCT00000384|Drug|Sertraline|
12085348|NCT00000383|Behavioral|Trauma-Focused CBT|Structured skills, exposure, trauma-specific interventions
12085349|NCT00000383|Behavioral|Child-Centered Therapy|Client-directed supportive interventions
12085350|NCT00000382|Behavioral|Infant-Parent Psychotherapy|
12085351|NCT00000382|Behavioral|Child Protective Services|
12085352|NCT00000382|Behavioral|Psychoeducational Home Visitation|
12085353|NCT00000382|Behavioral|Parent Education|
12085354|NCT00000381|Drug|Fluoxetine|
12085355|NCT00000380|Drug|GHRH|
12085356|NCT00000379|Drug|Fluoxetine|
12085357|NCT00000379|Behavioral|EMDR|
12085358|NCT00000378|Drug|Sertraline|12 week trial dose up to 200mgs
12085359|NCT00000378|Drug|Nortriptyline|12 week trial dose adjusted to therapeutic level
12085360|NCT00000377|Drug|Nortriptyline|
12085361|NCT00000376|Behavioral|Cognitive therapy|
12085362|NCT00000376|Drug|Desipramine|
12085363|NCT00000375|Drug|Nortriptyline-lithium (NOR-Li)|
12085364|NCT00000375|Procedure|Bilateral electroconvulsive therapy (ECT)|
12085365|NCT00000375|Drug|Continuation therapy|
12085366|NCT00000375|Behavioral|Continuation ECT|
12085367|NCT00000374|Drug|Olanzapine|The dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects.
12085368|NCT00000374|Drug|Risperidone|The dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects.
12085369|NCT00000373|Drug|olanzapine + fluoxetine|
12085370|NCT00000373|Drug|placebo + fluoxetine|
12085371|NCT00000372|Drug|D-cycloserine|
12085372|NCT00000372|Drug|Glycine|
12085373|NCT00000372|Drug|Clozapine|
12085374|NCT00000372|Drug|Placebo|
12085375|NCT00000371|Drug|D-cycloserine|50 mg/daily by mouth
12085376|NCT00000371|Drug|Placebo|50 mg/day of placebo by mouth
12085377|NCT00000370|Behavioral|Cognitive behavior therapy|
12085378|NCT00000370|Behavioral|Performance-based exposure therapy|
12085379|NCT00000370|Behavioral|Psychosocial intervention|
12085380|NCT00000369|Behavioral|Individual psychotherapy|
12085381|NCT00000369|Drug|Lithium carbonate|
12085382|NCT00000368|Behavioral|Cognitive behavior therapy|
12085383|NCT00000368|Drug|Paroxetine or other medication - algorithm used|
12085384|NCT00000367|Drug|Treatment of depression|
12085385|NCT00000367|Behavioral|Suicide prevention intervention|
12085386|NCT00000367|Drug|Suicide prevention treatment|
12085387|NCT00000363|Drug|Antihistamine|
12085388|NCT00000363|Drug|Corticosteroid|
12085389|NCT00000362|Behavioral|Chin-down position|
12085390|NCT00000362|Behavioral|Thickened liquid administration|
12085391|NCT00000361|Drug|Corticosteroids|
12085392|NCT00000361|Drug|Methotrexate|
12085393|NCT00000359|Behavioral|Canalith repositioning maneuver (Epley maneuver)|Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.
12085394|NCT00000359|Behavioral|Semont maneuver|Sidelying maneuver, flip over 180 deg, sit up.
12085395|NCT00000359|Behavioral|Brandt-Daroff exercises|Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.
12085396|NCT00000359|Behavioral|Vestibular habituation exercises|Head shaking exercises in pitch, roll, yaw and circumduction. Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated.
12085397|NCT00000359|Behavioral|ShamManeuver|Passive movement of the head
12085398|NCT00000180|Drug|AIT-082|
12085399|NCT00000179|Drug|Trazodone|
12085400|NCT00000179|Drug|Haloperidol|
12085401|NCT00000178|Drug|Prednisone|
12085402|NCT00000177|Drug|Estrogen|
12085403|NCT00000176|Drug|Estrogen|
12085404|NCT00000176|Drug|Estrogen and Progesterone|
12085405|NCT00000175|Drug|Estrogen|
12085406|NCT00000175|Drug|Testosterone|
12085407|NCT00000174|Drug|Rivastigmine|
12085408|NCT00000173|Drug|Donepezil|
12085409|NCT00000173|Drug|Vitamin E|
12085410|NCT00000172|Drug|Galantamine|
12085411|NCT00000171|Drug|Melatonin|
12085412|NCT00000623|Drug|Deferoxamine|
12085413|NCT00000623|Drug|Deferiprone|
12085414|NCT00000623|Drug|Arginine|
12085415|NCT00000623|Drug|Sildenafil|
12085416|NCT00000623|Drug|Decitabine|
12085417|NCT00000621|Drug|all trans retinoic acid|
12085418|NCT00000621|Drug|13 cis retinoic acid|
12085419|NCT00000621|Drug|placebo|
12085420|NCT00000620|Drug|Anti-hyperglycemic Agents|Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control <6%; standard control 7.0-7.9%).
12085421|NCT00000620|Drug|Anti-hypertensive Agents|Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg).
12085422|NCT00000620|Drug|Blinded fenofibrate or placebo plus simvastatin|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day.
12085423|NCT00000619|Procedure|catheterization, Swan-Ganz|
12085424|NCT00000617|Drug|azithromycin|
12085425|NCT00000616|Behavioral|diet, sodium-restricted|
12085426|NCT00000616|Behavioral|diet, fat-restricted|
12085427|NCT00000616|Behavioral|exercise|
12085428|NCT00000616|Behavioral|diet, reducing|
12085429|NCT00000616|Behavioral|alcohol drinking|
12085430|NCT00000615|Behavioral|diet, reducing|
12085431|NCT00000614|Drug|warfarin|
12085432|NCT00000613|Behavioral|dietary supplements|
12085433|NCT00000613|Drug|genistein|
12085434|NCT00000613|Behavioral|diet, soy proteins|
12085435|NCT00000612|Drug|estrogens, conjugated|
12085436|NCT00000612|Behavioral|diet, soy proteins|
12085437|NCT00000612|Behavioral|dietary supplements|
12085438|NCT00000611|Drug|hormone replacement therapy|
12085439|NCT00000611|Drug|estrogens|
12085440|NCT00000611|Drug|progestins|
12085441|NCT00000611|Drug|estrogen replacement therapy|
12085442|NCT00000611|Behavioral|diet, fat-restricted|
12085443|NCT00000611|Drug|calcium|
12085444|NCT00000611|Drug|vitamin D|
12085445|NCT00000611|Behavioral|dietary supplements|
12085446|NCT00000610|Drug|magnesium|
12085447|NCT00000609|Drug|amiodarone|
12085448|NCT00000609|Device|defibrillators, implantable|
12085449|NCT00000608|Behavioral|diet, fat-restricted|
12085450|NCT00000608|Behavioral|diet, sodium-restricted|
12085451|NCT00000607|Device|Left ventricular assist device|A type of implantable heart pump
12085452|NCT00000607|Device|Optimal medical therapy|(non-experimental) One possibility in handling Heart failure effectively is optimal medicine therapy. The most popular treatment medications at present are ACE Inhibitors and Beta Blockers. The result is the heart being able to pump more effectively and allowing blood to circulate freely.
12085453|NCT00000606|Procedure|Lung volume reduction surgery|
12085454|NCT00000605|Drug|hormone replacement therapy|
12085455|NCT00000605|Drug|estrogens|
12085456|NCT00000605|Drug|medroxyprogesterone|
12085457|NCT00000604|Procedure|cardiopulmonary bypass|
12085458|NCT00000604|Procedure|heart arrest, induced|
12085459|NCT00000603|Procedure|stem cell transplantation|
12085460|NCT00000602|Drug|hydroxyurea|
12085461|NCT00000601|Drug|estrogen replacement therapy|
12085462|NCT00000601|Drug|estrogens|
12085463|NCT00000601|Drug|progesterone|
12085464|NCT00000601|Drug|hormone replacement therapy|
12085465|NCT00000600|Drug|Vitamin E|
12085466|NCT00000600|Drug|Vitamin C|
12085467|NCT00000599|Drug|colestipol|
12085468|NCT00000599|Drug|niacin|
12085469|NCT00000599|Behavioral|diet, fat-restricted|
12085470|NCT00000598|Behavioral|diet, fat-restricted|
12085471|NCT00000598|Behavioral|exercise|
12085472|NCT00000597|Drug|antilymphocyte serum|
12085473|NCT00000597|Drug|nandrolone|
12085474|NCT00000596|Drug|prednisone|
12085475|NCT00000596|Drug|cyclophosphamide|
12085476|NCT00000596|Drug|dapsone|
12085477|NCT00000595|Drug|deferoxamine|
12085478|NCT00000594|Drug|cholestyramine|
12085479|NCT00000593|Procedure|blood transfusion|
12085480|NCT00000592|Procedure|blood transfusion|
12085481|NCT00000591|Procedure|lymphocyte depletion|
12085482|NCT00000590|Drug|immunoglobulins|
12085483|NCT00000589|Procedure|platelet transfusion|
12085484|NCT00000588|Drug|chelation therapy|
12085485|NCT00000587|Procedure|erythropoietin, recombinant|
12085486|NCT00000586|Drug|hydroxyurea|
12085487|NCT00000585|Drug|penicillin|
12085488|NCT00000584|Drug|immunoglobulins|
12085489|NCT00000583|Biological|hepatitis B vaccines|
12085490|NCT00000582|Drug|factor ix|
12085491|NCT00000581|Procedure|leukocyte transfusions|
12085492|NCT00000580|Drug|immunoglobulins, intravenous|
12085493|NCT00000579|Procedure|Low Tidal Volume Ventilation|
12085494|NCT00000579|Procedure|Positive End-Expiratory Pressure|
12085495|NCT00000579|Drug|Lysofylline|
12085496|NCT00000579|Drug|Methylprednisolone|
12085497|NCT00000579|Drug|Ketoconazole|
12085498|NCT00000579|Procedure|Fluid Management|
12085499|NCT00000579|Procedure|Pulmonary Artery Catheter|
12085500|NCT00000578|Drug|theophylline|
12085501|NCT00000578|Drug|beclomethasone|
12085502|NCT00000577|Drug|Albuterol|
12085503|NCT00000577|Drug|Colchicine|
12085504|NCT00000577|Drug|Adrenal Cortex Hormones|
12085505|NCT00000577|Drug|Adrenergic-Beta Agonists|
12085506|NCT00000576|Drug|beclomethasone|
12085507|NCT00000575|Drug|Placebo|Two 100 Og puffs budesonide placebo bid + two 90 Og puffs albuterol prn OR four 2 mg puffs nedocromil placebo bid + two 90 Og puffs albuterol prn.
12085508|NCT00000575|Drug|Nedocromil|Four 2 mg puffs bid + two 90 Og puffs albuterol prn
12085509|NCT00000575|Drug|Budesonide|Two 100 Og puffs bid + two 90 Og puffs albuterol prn.
12085510|NCT00000574|Drug|ibuprofen|
12085511|NCT00000573|Procedure|enteral nutrition|
12085512|NCT00000572|Procedure|positive-pressure ventilation|Detailed computer protocol controlled positive pressure ventilation
12085513|NCT00000572|Procedure|extracorporeal membrane oxygenation (CO2 removal)|Detailed computer protocol controlled Extracorporeal CO2 Removal with reduced positive pressure ventilation
12085514|NCT00000571|Device|ventilators, negative pressure|
12085515|NCT00000570|Drug|pulmonary surfactant|
12085516|NCT00000569|Drug|triamcinolone|1200 micrograms of triamcinolone in daily divided doses
12085517|NCT00000569|Other|Placebo|Placebo
12085518|NCT00000568|Behavioral|smoking cessation|
12085519|NCT00000568|Drug|ipratropium|
12085520|NCT00000567|Procedure|high-frequency ventilation|
12085521|NCT00000566|Procedure|ventilation-perfusion ratio|
12085522|NCT00000566|Procedure|angiography|
12085523|NCT00000565|Procedure|intermittent positive-pressure breathing|
12085524|NCT00000564|Procedure|oxygen inhalation therapy|
12085525|NCT00000563|Drug|dexamethasone|
12085526|NCT00000562|Procedure|extracorporeal membrane oxygenation|
12085527|NCT00000561|Device|pacemaker, artificial|
12085528|NCT00000560|Drug|adrenergic beta antagonists|
12085529|NCT00000559|Drug|estrogen replacement therapy|
12085530|NCT00000559|Drug|hormone replacement therapy|
12085531|NCT00000559|Drug|estradiol|
12085532|NCT00000559|Drug|medroxyprogesterone|
12085533|NCT00000558|Drug|angiotensin-converting enzyme inhibitors|
12085534|NCT00000557|Behavioral|social support|
12085535|NCT00000556|Drug|amiodarone|
12085536|NCT00000556|Drug|sotalol|
12085537|NCT00000556|Drug|propafenone|
12085538|NCT00000556|Drug|flecainide|
12085539|NCT00000556|Drug|quinidine|
12085540|NCT00000556|Drug|moricizine|
12085541|NCT00000556|Drug|disopyramide|
12085542|NCT00000556|Drug|procainamide|
12085543|NCT00000556|Drug|adrenergic beta antagonists|
12085544|NCT00000556|Drug|verapamil|
12085545|NCT00000556|Drug|diltiazem|
12085546|NCT00000556|Drug|digoxin|
12085547|NCT00000556|Procedure|catheter ablation|
12085548|NCT00000556|Device|pacemaker, artificial|
12085549|NCT00000555|Drug|estrogen replacement therapy|
12085550|NCT00000555|Drug|estrogens, conjugated|
12085551|NCT00000555|Drug|progesterone|
12085552|NCT00000555|Drug|hormone replacement therapy|
12085553|NCT00000555|Drug|supplementation, food|
12085554|NCT00000555|Drug|ascorbic acid|
12085555|NCT00000555|Drug|vitamin e|
12085556|NCT00000554|Procedure|Angiography, MRI, Dobutamine-Stress Echocardiography, PET,|
12085557|NCT00000554|Procedure|Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing|
12085558|NCT00000553|Drug|simvastatin|
12085559|NCT00000553|Drug|niacin|
12085560|NCT00000553|Drug|antioxidants|
12085561|NCT00000552|Procedure|angioplasty, transluminal, percutaneous coronary|
12085562|NCT00000552|Procedure|coronary artery bypass|
12085563|NCT00000552|Drug|thrombolytic therapy|
12085564|NCT00000551|Behavioral|health education|
12085565|NCT00000550|Behavioral|health education|
12085566|NCT00000549|Drug|estrogen replacement therapy|
12085567|NCT00000549|Drug|hormone replacement therapy|
12085568|NCT00000549|Drug|estrogens|
12085569|NCT00000549|Drug|progestins|
12085570|NCT00000548|Procedure|mechanical ventilation|
12085571|NCT00000547|Drug|enalapril|
12085572|NCT00000546|Behavioral|meditation|
12085573|NCT00000545|Behavioral|exercise|
12085574|NCT00000545|Behavioral|diet|
12085575|NCT00000544|Behavioral|diet therapy|
12085576|NCT00000543|Behavioral|dietary supplements|
12085577|NCT00000543|Drug|calcium|
12085578|NCT00000542|Drug|Inhibitors, ACE|
12085579|NCT00000542|Drug|amlodipine|
12085580|NCT00000542|Drug|lisinopril|
12085581|NCT00000542|Drug|doxazosin|
12085582|NCT00000542|Drug|chlorthalidone|
12085583|NCT00000542|Drug|pravastatin|
12085584|NCT00000542|Behavioral|diet, fat-restricted|
12085585|NCT00000541|Behavioral|dietary supplements|
12085586|NCT00000541|Drug|vitamin C|
12085587|NCT00000541|Drug|vitamin E|
12085588|NCT00000541|Drug|beta-carotene|
12085589|NCT00000541|Drug|folic acid/Vitamin B6/Vitamin B12|
12085590|NCT00000540|Device|defibrillators, implantable|
12085591|NCT00000539|Drug|niacin|
12085592|NCT00000539|Drug|pravastatin|
12085593|NCT00000539|Drug|beta-carotene|
12085594|NCT00000539|Drug|vitamin E|
12085595|NCT00000539|Behavioral|dietary supplements|
12085596|NCT00000539|Drug|vitamin C|
12085597|NCT00000539|Drug|warfarin|
12085598|NCT00000538|Behavioral|diet, fat-restricted|
12085599|NCT00000537|Behavioral|meditation|
12085600|NCT00000537|Behavioral|relaxation|
12085601|NCT00000536|Behavioral|sodium, dietary|
12085602|NCT00000535|Behavioral|diet, reducing|
12085603|NCT00000535|Behavioral|diet, sodium-restricted|
12085604|NCT00000534|Drug|calcium|
12085605|NCT00000534|Behavioral|dietary supplements|
12085606|NCT00000533|Behavioral|social support|
12085607|NCT00000532|Behavioral|diet, fat-restricted|
12085608|NCT00000531|Device|defibrillators, implantable|
12085609|NCT00000531|Drug|amiodarone amiodarone|
12085610|NCT00000531|Drug|sotalol|
12085611|NCT00000530|Drug|nifedipine|
12085612|NCT00000530|Behavioral|biofeedback (psychology)|
12085613|NCT00000530|Procedure|electromyography|
12085614|NCT00000529|Drug|tamoxifen|
12085615|NCT00000528|Behavioral|diet, sodium-restricted (Phase III) diet, sodium-restricted|
12085616|NCT00000528|Behavioral|diet, reducing (Phase III)|
12085617|NCT00000527|Drug|aspirin|
12085618|NCT00000527|Drug|dipyridamole|
12085619|NCT00000526|Drug|encainide|
12085620|NCT00000526|Drug|flecainide|
12085621|NCT00000526|Drug|moricizine|
12085622|NCT00000525|Drug|hydrochlorothiazide|
12085623|NCT00000525|Behavioral|diet, potassium supplementation|
12085624|NCT00000525|Behavioral|diet, magnesium supplementation|
12085625|NCT00000525|Drug|triamterene|
12085626|NCT00000525|Drug|chlorthalidone|
12085627|NCT00000524|Drug|cyclosporine|
12085628|NCT00000524|Drug|prednisone|
12085629|NCT00000523|Behavioral|exercise|
12085630|NCT00000522|Behavioral|diet, sodium-restricted|
12085631|NCT00000522|Behavioral|diet, reducing|
12085632|NCT00000522|Behavioral|exercise|
12085633|NCT00000522|Behavioral|alcohol restriction|
12085634|NCT00000522|Drug|chlorthalidone|
12085635|NCT00000522|Drug|acebutolol|
12085636|NCT00000522|Drug|doxazosin|
12085637|NCT00000522|Drug|amlodipine|
12085638|NCT00000522|Drug|enalapril|
12085639|NCT00000521|Behavioral|diet, sodium-restricted|
12085640|NCT00000521|Behavioral|diet, potassium-supplemented|
12085641|NCT00000520|Drug|immunoglobulins, intravenous|
12085642|NCT00000520|Drug|aspirin|
12085643|NCT00000519|Behavioral|diet, reducing|
12085644|NCT00000519|Behavioral|exercise|
12085645|NCT00000519|Behavioral|diet, fat-restricted|
12085646|NCT00000518|Procedure|electrophysiology|
12085647|NCT00000518|Procedure|electrocardiography, ambulatory|
12085648|NCT00000518|Drug|imipramine|
12085649|NCT00000518|Drug|mexiletine|
12085650|NCT00000518|Drug|procainamide|
12085651|NCT00000518|Drug|quinidine|
12085652|NCT00000518|Drug|sotalol|
12085653|NCT00000517|Drug|warfarin|
12085654|NCT00000516|Drug|enalapril|
12085655|NCT00000515|Behavioral|diet, reducing|
12085656|NCT00000514|Drug|chlorthalidone|
12085657|NCT00000514|Drug|atenolol|
12085658|NCT00000514|Drug|reserpine|
12085659|NCT00000513|Behavioral|diet, reducing|
12085660|NCT00000513|Behavioral|diet, sodium-restricted|
12085661|NCT00000513|Drug|chlorthalidone|
12085662|NCT00000513|Drug|atenolol|
12085663|NCT00000512|Drug|lovastatin|Lovastatin was begun at a dose of 20 mg twice a day (in the morning and at bedtime). If the LDL cholesterol level did not fall below 3.1 mmol per liter after three months, the dose of lovastatin was increased to 40 mg twice a day.
12085664|NCT00000512|Drug|colestipol|Colestipol was begun at a dose of 5 g three times a day with meals and increased to 10 g three times a day after 10 days, unless side effects delayed the increase. Psyllium hydrophic mucilloid (Metamucil) was provided if dietary bran was insufficient to control constipation.
12085665|NCT00000512|Drug|niacin|Niacin was started at 125 mg twice a day and gradually increased to 500 mg four times a day (with meals and at bedtime) at one month and 1 g four times a day at two months. If the LDL cholesterol level did not fall below 3.1 mmol per liter (120 mg per deciliter) after three months, the dose of niacin was increased to 1.5 g (three tablets) four times a day, but no further.
12085666|NCT00000512|Other|Placebo for colestipol|Placebo for colestipol.
12085667|NCT00000512|Other|Placebo for lovastatin|Placebo for lovastatin
12085668|NCT00000511|Dietary Supplement|mineral supplements|
12085669|NCT00000511|Dietary Supplement|Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements|
12085670|NCT00000511|Behavioral|dietary supplements|
12085671|NCT00000510|Drug|aspirin|
12085672|NCT00000510|Drug|dipyridamole|
12085673|NCT00000510|Procedure|angioplasty, transluminal, percutaneous coronary|
12085674|NCT00000509|Behavioral|diet, sodium-restricted|
12085675|NCT00000509|Behavioral|diet, potassium-supplementation|
12085676|NCT00000508|Behavioral|smoking cessation|
12085677|NCT00000508|Behavioral|diet, reducing|
12085678|NCT00000508|Behavioral|exercise|
12085679|NCT00000508|Behavioral|diet, fat-restricted|
12085680|NCT00000507|Drug|streptokinase|
12085681|NCT00000506|Drug|fenfluramine|
12085682|NCT00000506|Drug|phentermine|
12085683|NCT00000505|Drug|tissue plasminogen activator|
12085684|NCT00000505|Procedure|angioplasty, transluminal, percutaneous coronary|
12085685|NCT00000504|Drug|encainide|
12085686|NCT00000504|Drug|moricizine|
12085687|NCT00000504|Drug|flecainide|
12085688|NCT00000504|Drug|imipramine|
12085689|NCT00000503|Drug|nitroglycerin|
12085690|NCT00000503|Drug|streptokinase|
12085691|NCT00000503|Procedure|heart catheterization|
12085692|NCT00000502|Procedure|cardiopulmonary resuscitation|
12085693|NCT00000501|Behavioral|diet, sodium-restricted|
12085694|NCT00000501|Behavioral|diet, reducing|
12085695|NCT00000501|Drug|potassium|
12085696|NCT00000500|Drug|aspirin|
12085697|NCT00000500|Drug|carotene|
12085698|NCT00000499|Drug|chlorthalidone|
12085699|NCT00000499|Drug|reserpine|
12085700|NCT00000499|Drug|hydralazine|
12085701|NCT00000499|Drug|metoprolol|
12085702|NCT00000498|Behavioral|diet, sodium-restricted|
12085703|NCT00000498|Behavioral|diet, reducing|
12085704|NCT00000498|Behavioral|alcohol restriction|
12085705|NCT00000498|Drug|antihypertensive agents|
12085706|NCT00000497|Behavioral|diet, sodium-restricted|
12085707|NCT00000497|Behavioral|diet, reducing|
12085708|NCT00000496|Drug|aspirin|
12085709|NCT00000496|Drug|dipyridamole|
12085710|NCT00000495|Behavioral|diet, reducing|
12085711|NCT00000495|Behavioral|diet, sodium-restricted|
12085712|NCT00000495|Behavioral|alcohol restriction|
12085713|NCT00000495|Behavioral|exercise|
12085714|NCT00000494|Drug|indomethacin|
12085715|NCT00000494|Procedure|surgery, cardiovascular|
12085716|NCT00000493|Drug|propranolol|
12085717|NCT00000493|Drug|hyaluronidase|
12085718|NCT00000492|Drug|propranolol|
12085719|NCT00000491|Drug|aspirin|
12085720|NCT00000490|Procedure|jejunoileal bypass|
12085721|NCT00000490|Behavioral|diet, fat-restricted|
12085722|NCT00000489|Procedure|coronary artery bypass|
12085723|NCT00000488|Drug|cholestyramine|
12085724|NCT00000488|Behavioral|diet, fat-restricted|
12085725|NCT00000487|Drug|antihypertensive agents|
12085726|NCT00000487|Behavioral|smoking cessation|
12085727|NCT00000487|Behavioral|diet, fat-restricted|
12085728|NCT00000487|Drug|diuretics|
12085729|NCT00000486|Procedure|coronary artery bypass|
12085730|NCT00000485|Drug|diuretics|
12085731|NCT00000485|Drug|antihypertensive agents|
12085732|NCT00000484|Drug|chlorothiazide|
12085733|NCT00000484|Drug|Rauwolfia alkaloids|
12085734|NCT00000483|Drug|estrogen|
12085735|NCT00000483|Drug|clofibrate|
12085736|NCT00000483|Drug|dextrothyroxine sodium|
12085737|NCT00000483|Drug|niacin|
12085738|NCT00000482|Drug|estrogen|
12085739|NCT00000482|Drug|clofibrate clofibrate|
12085740|NCT00000482|Drug|dextrothyroxine sodium|
12085742|NCT00000481|Behavioral|diet, fat-restricted|
12085743|NCT00000480|Procedure|electrophysiology|
12085744|NCT00000480|Drug|anti-arrhythmia agents|
12085745|NCT00000480|Device|defibrillators, implantable|
12085746|NCT00000479|Drug|Aspirin|Participants will receive 100 mg of aspirin every other day.
12085747|NCT00000479|Drug|Vitamin E|Participants will receive 600 IU of vitamin E every other day.
12085748|NCT00000479|Behavioral|Placebo|Participants will receive placebo.
12085749|NCT00000478|Drug|atenolol|
12085750|NCT00000478|Drug|nifedipine|
12085751|NCT00000478|Drug|diltiazem|
12085752|NCT00000478|Drug|isosorbide dinitrate|
12085753|NCT00000478|Procedure|coronary artery bypass coronary artery bypass|
12085754|NCT00000478|Procedure|angioplasty, transluminal, percutaneous coronary|
12085755|NCT00000477|Drug|lovastatin|
12085756|NCT00000476|Drug|digitalis|
12085757|NCT00000475|Behavioral|health education|
12085758|NCT00000474|Behavioral|behavior therapy|
12085759|NCT00000473|Behavioral|dietary supplements|
12085760|NCT00000473|Drug|fatty acids, omega-3|
12085761|NCT00000473|Behavioral|diet, fat-restricted|
12085762|NCT00000472|Drug|tissue plasminogen activator|
12085763|NCT00000472|Drug|heparin|
12085764|NCT00000471|Behavioral|diet, vegetarianism|
12085765|NCT00000471|Behavioral|diet, fat-restricted|
12085766|NCT00000471|Behavioral|exercise|
12085767|NCT00000471|Behavioral|smoking cessation|
12085768|NCT00000470|Procedure|cardiac surgical procedures|
12085769|NCT00000470|Procedure|cardiopulmonary bypass|
12085770|NCT00000469|Drug|aspirin|
12085771|NCT00000469|Drug|lovastatin|
12085772|NCT00000468|Drug|tissue plasminogen activator|
12085773|NCT00000467|Behavioral|diet|
12085774|NCT00000467|Behavioral|exercise|
12085775|NCT00000467|Behavioral|smoking cessation|
12085776|NCT00000466|Drug|estrogens, conjugated|
12085777|NCT00000466|Drug|medroxyprogesterone|
12085778|NCT00000466|Drug|progesterone|
12085779|NCT00000466|Drug|estrogen replacement therapy|
12085780|NCT00000465|Procedure|angioplasty, transluminal, percutaneous coronary|
12085781|NCT00000465|Procedure|coronary artery bypass|
12085782|NCT00000464|Drug|amiodarone|
12085783|NCT00000464|Drug|imipramine|
12085784|NCT00000464|Drug|mexiletine|
12085785|NCT00000464|Drug|procainamide|
12085786|NCT00000464|Drug|propafenone|
12085787|NCT00000464|Drug|quinidine|
12085788|NCT00000464|Drug|sotalol|
12085789|NCT00000463|Drug|lovastatin|
12085790|NCT00000463|Drug|cholestyramine|
12085791|NCT00000463|Drug|warfarin|
12085792|NCT00000462|Procedure|angioplasty, transluminal, percutaneous coronary|
12085793|NCT00000462|Procedure|coronary artery bypass|
12085794|NCT00000461|Drug|pravastatin|
12085795|NCT00000461|Drug|niacin|
12085796|NCT00000461|Drug|cholestyramine|
12085797|NCT00000461|Drug|gemfibrozil|
12085798|NCT00000461|Drug|fatty acids, omega-3|
12085799|NCT00000460|Behavioral|Low intensity exercise|
12085800|NCT00000460|Behavioral|High intensity exercise|
12085801|NCT00000459|Behavioral|diet, fat-restricted|
12085802|NCT00004500|Drug|Lucinactant|Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other.
12085803|NCT00004500|Other|Standard Care|The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC
12085804|NCT00004498|Genetic|Adenoviral Vector-Mediated Gene Transfer|
12085805|NCT00004497|Drug|UT-15|
12085806|NCT00004496|Drug|alpha-melanocyte stimulating hormone|
12085807|NCT00004495|Drug|cyanocobalamin|
12085808|NCT00004495|Drug|folic acid|
12085809|NCT00004495|Drug|pyridoxine|
12085810|NCT00004494|Drug|vasoactive intestinal peptide|
12085811|NCT00004493|Drug|sodium dichloroacetate|
12085812|NCT00004492|Drug|clotrimazole|
12085813|NCT00004492|Drug|hydroxyurea|
12085814|NCT00004490|Drug|sodium dichloroacetate|
12085815|NCT00004489|Drug|alendronate sodium|
12085816|NCT00004489|Drug|calcium carbonate|
12085817|NCT00004489|Drug|cholecalciferol|
12085818|NCT00004488|Drug|alendronate sodium|
12085819|NCT00004488|Drug|calcium carbonate|
12085820|NCT00004488|Drug|cholecalciferol|
12085821|NCT00004487|Drug|chondrocyte-alginate gel suspension|
12085822|NCT00004486|Drug|fluoxetine|
12085823|NCT00004485|Drug|cyclosporine|
12085824|NCT00004485|Drug|fludarabine|
12085825|NCT00004485|Drug|mycophenolate mofetil|
12085826|NCT00004485|Procedure|Bone Marrow Transplantation|
12085827|NCT00004482|Drug|Cyclosporine|
12085828|NCT00004482|Drug|methylprednisolone|
12085829|NCT00004482|Drug|Muromonab-CD3|
12085830|NCT00004482|Drug|prednisone|
12085831|NCT00004481|Procedure|genetic testing|
12085832|NCT00004480|Drug|botulinum toxin type A|
12085833|NCT00004479|Drug|midodrine|
12085834|NCT00004478|Drug|droxidopa|
12085835|NCT00004474|Drug|Anti-thymocyte globulin|Given via IV over 4 hours
12085836|NCT00004474|Drug|Cyclophosphamide|Given via IV over 60 minutes on Days -5 to -2
12085837|NCT00004474|Procedure|Bone marrow transplantation|Given on Day 0
12085838|NCT00004471|Genetic|pGT-1 gene lipid complex|
12085839|NCT00004468|Drug|calcitriol|
12085840|NCT00004467|Drug|N-acetylcysteine (NAC)|Infusion of 5% dextrose with N-acetylcysteine with an initial loading dose of 150 mg/kg/h of NAC over 1 hour, followed by 12.5 mg/kg/h for 4 hours, then continuous infusions of 6.25 mg/kg/h for the remaining 67 hours.
12085841|NCT00004467|Drug|Placebo|Infusion of 5% dextrose
12085842|NCT00004466|Drug|Atorvastatin|
12085843|NCT00004466|Drug|Placebo|
12085844|NCT00004465|Drug|SYNSORB Pk|
12085845|NCT00004465|Drug|Placebo|
12085846|NCT00004464|Drug|cyclophosphamide|
12085847|NCT00004464|Drug|filgrastim|
12085848|NCT00004454|Genetic|lymphocyte gene therapy|
12085849|NCT00004451|Drug|Glucose|
12085850|NCT00004450|Drug|glyceryl trierucate|
12085851|NCT00004450|Drug|glyceryl trioleate|
12085852|NCT00004450|Drug|interferon beta|
12085853|NCT00004450|Drug|thalidomide|
12085854|NCT00004449|Behavioral|intensive one-on-one behavioral treatment|Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
12085855|NCT00004449|Behavioral|Individualized in home parent training|Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
12085856|NCT00004448|Drug|omega-3 fatty acids|
12085857|NCT00004448|Drug|prednisone|
12085858|NCT00004446|Drug|fluoxetine|
12085859|NCT00004445|Procedure|Surgery|
12085860|NCT00004445|Device|IRS-8|
12085861|NCT00004444|Drug|paromomycin|
12085862|NCT00004444|Drug|streptomycin|
12085863|NCT00004443|Drug|NTBC|
12085864|NCT00004442|Drug|chenodeoxycholic acid|
12085865|NCT00004442|Drug|cholic acid|
12085866|NCT00004442|Drug|ursodiol|
12085867|NCT00004441|Drug|tauroursodeoxycholic acid|
12085868|NCT00004441|Drug|ursodiol|
12085869|NCT00004440|Drug|ibuprofen|
12085870|NCT00004438|Drug|leuprolide|
12085871|NCT00004437|Device|Multichannel Auditory Brain Stem Implant|
12085872|NCT00004436|Drug|leuprolide|
12085873|NCT00004436|Drug|prednisone|
12085874|NCT00004433|Drug|pergolide|
12085875|NCT00004431|Drug|L-baclofen|
12085876|NCT00004430|Drug|Dihematoporphyrin derivative|
12085877|NCT00004430|Drug|prednisolone|
12085878|NCT00004430|Procedure|Laser surgery|
12085879|NCT00004429|Drug|growth hormone|
12085880|NCT00004428|Drug|CPX|
12085881|NCT00004426|Drug|gonadotropin releasing hormone|
12085882|NCT00004426|Drug|leuprolide|
12085883|NCT00004424|Drug|fentanyl|
12085884|NCT00004424|Drug|Midazolam|
12085885|NCT00004424|Drug|propofol|
12085886|NCT00004423|Drug|-aminosalicylic acid|
12085887|NCT00004422|Drug|immune globulin|
12085888|NCT00004421|Device|implanted pulse generator|
12085889|NCT00004420|Drug|gamma-Linolenic acid|
12085890|NCT00004419|Drug|insulin-like growth factor I|
12085891|NCT00004418|Drug|glyceryl trierucate/glyceryl trioleate|Administration of glyceryl trierucate/glyceryl trioleate
12085892|NCT00004416|Drug|botulinum toxin type A|
12085893|NCT00004415|Device|Medlink spinal cord electrode|
12085894|NCT00004414|Drug|sincalide|
12085895|NCT00004412|Drug|Arginine Butyrate|To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone.
12085896|NCT00004412|Other|Standard local care dressing|To heal leg ulcers.
12085897|NCT00004410|Drug|tauroursodeoxycholic acid|
12085898|NCT00004409|Drug|collagenase|
12085899|NCT00004408|Drug|poloxamer 188|
12085900|NCT00004407|Drug|immune globulin|
12085901|NCT00004406|Drug|human parathyroid hormone|
12085902|NCT00004404|Drug|clotrimazole|
12085903|NCT00004404|Drug|hydroxyurea|
12085904|NCT00004403|Drug|albendazole|
12085905|NCT00004403|Drug|dexamethasone|
12085906|NCT00004403|Drug|phenytoin|
12085907|NCT00004402|Drug|calcitriol|
12085908|NCT00004402|Drug|interferon gamma|
12085909|NCT00004401|Drug|botulism immune globulin|
12085910|NCT00004400|Drug|testosterone|
12085911|NCT00004399|Drug|magnesium sulfate|
12085912|NCT00004399|Drug|nimodipine|
12085913|NCT00004398|Drug|heme arginate|
12085914|NCT00004398|Drug|tin mesoporphyrin|
12085915|NCT00004397|Drug|heme arginate|
12085916|NCT00004397|Drug|tin mesoporphyrin|
12085917|NCT00004396|Drug|heme arginate|
12085918|NCT00004396|Drug|tin mesoporphyrin|
12085919|NCT00004393|Drug|risperidone|
12085920|NCT00004390|Drug|desipramine|
12085921|NCT00004390|Drug|methadone|
12085922|NCT00004390|Drug|morphine|
12085923|NCT00004390|Drug|nortriptyline|
12085924|NCT00004387|Procedure|fetal nigral transplantation|
12085925|NCT00004386|Genetic|recombinant adenovirus containing the ornithine transcarbamylase gene|
12085926|NCT00004382|Drug|tin mesoporphyrin|
12085927|NCT00004382|Procedure|Phototherapy|
12085928|NCT00004381|Drug|tin mesoporphyrin|
12085929|NCT00004380|Drug|relaxin|
12085930|NCT00004378|Procedure|Stem Cell Transplantation|
12085931|NCT00004376|Drug|guanfacine|
12085932|NCT00004375|Procedure|ultraviolet A-1 light treatment|
12085933|NCT00004373|Drug|alprazolam|
12085934|NCT00004368|Drug|colchicine|
12085935|NCT00004367|Procedure|Clinical vestibular tests|
12085936|NCT00004366|Procedure|Physical therapy|
12085937|NCT00004364|Drug|desmopressin|
12085938|NCT00004363|Drug|chlorpropamide|
12085939|NCT00004363|Drug|desmopressin|
12085940|NCT00004361|Drug|calcium gluconate|
12085941|NCT00004361|Drug|sodium citrate|
12085942|NCT00004360|Drug|chlorothiazide|
12085943|NCT00004359|Drug|methoxsalen|
12085944|NCT00004358|Drug|calcitonin|
12085945|NCT00004357|Drug|Methylprednisolone|IV
12085946|NCT00004357|Drug|Prednisolone|Oral
12085947|NCT00004347|Behavioral|diet|
12085948|NCT00004346|Drug|chenodeoxycholic acid|
12085949|NCT00004346|Drug|lovastatin|
12085950|NCT00004344|Drug|leuprolide|
12085951|NCT00004344|Drug|testosterone|
12085952|NCT00004340|Drug|calcitriol|
12085953|NCT00004340|Drug|growth hormone|
12085954|NCT00004339|Drug|tetrathiomolybdate|
12085955|NCT00004339|Drug|trientine|
12085956|NCT00004338|Drug|zinc acetate|
12085957|NCT00004333|Drug|NTBC|
12085958|NCT00004330|Drug|luteinizing hormone-releasing factor|
12085959|NCT00004328|Drug|enalapril|
12085960|NCT00004328|Drug|polystyrene sulfonate|
12085961|NCT00004327|Drug|octreotide|
12085962|NCT00004323|Drug|anti-thymocyte globulin|
12085963|NCT00004323|Drug|cyclophosphamide|
12085964|NCT00004323|Drug|cyclosporine|
12085965|NCT00004323|Drug|mesna|
12085966|NCT00004323|Drug|methotrexate|
12085967|NCT00004323|Drug|methylprednisolone|
12085968|NCT00004317|Drug|Leucovorin calcium|See arm descriptions
12085969|NCT00004317|Drug|Pyrimethamine|See arm descriptions
12085970|NCT00004317|Drug|Spiramycin|Spiramycin is administered before the fetal diagnosis is made.
12085971|NCT00004317|Drug|Sulfadiazine|See arm descriptions
12085972|NCT00004316|Drug|capsaicin|
12085973|NCT00004315|Drug|ursodiol|
12085974|NCT00004314|Drug|aminomidazole carboxamide riboside|
12085975|NCT00004313|Drug|dehydroepiandrosterone|
12085976|NCT00004311|Drug|leuprolide acetate|
12085977|NCT00004311|Drug|spironolactone|
12085978|NCT00004310|Drug|Clomipramine|
12085979|NCT00004307|Behavioral|Protein and calorie controlled diet|
12085980|NCT00004307|Genetic|Ornithine transcarbamylase vector|
12085981|NCT00004300|Drug|bromocriptine|
12085982|NCT00004300|Drug|sertraline hydrochloride|
12085983|NCT00004297|Drug|diazepam|
12085984|NCT00004297|Drug|lorazepam|
12085985|NCT00004294|Genetic|human glucocerebrosidase gene into autologous peripheral blood stem cells|
12085986|NCT00004293|Drug|glucocerebrosidase|
12085987|NCT00004288|Drug|olsalazine|
12085988|NCT00004287|Genetic|H5.001CBCFTR|
12085989|NCT00004286|Drug|immune globulin|
12085990|NCT00004285|Device|Standard dose, low flux hemodialysis|
12085991|NCT00004285|Device|Standard dose, high flux hemodialysis|
12085992|NCT00004285|Device|High dose, low flux hemodialysis|
12085993|NCT00004285|Device|High dose, high flux hemodialysis|
12085994|NCT00004284|Drug|potassium citrate|
12085995|NCT00004284|Drug|potassium phosphate|
12085996|NCT00004278|Drug|ganciclovir|
12085997|NCT00004276|Drug|thalidomide|
12085998|NCT00004275|Drug|growth hormone|
12085999|NCT00004275|Drug|oxandrolone|
12086000|NCT00004274|Drug|Estrogen|
12086001|NCT00004268|Drug|midodrine|
12086002|NCT00004266|Drug|Lisinopril|
12086003|NCT00004266|Drug|Nifedipine|
12086004|NCT00004266|Drug|Simvastatin|
12086005|NCT00000170|Drug|Atropine|Atropine
12086006|NCT00000170|Device|Eye Patch|Patching
12086007|NCT00000167|Procedure|Low-Intensity Laser Treatment|Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.
12086008|NCT00000162|Procedure|Macular Argon Laser Photocoagulation|
12086009|NCT00000162|Procedure|Peripheral Scatter Argon Laser Photocoagulation|
12086010|NCT00000162|Procedure|Scatter Argon Laser Photocoagulation|
12086011|NCT00000161|Drug|Aspirin|
12086012|NCT00000161|Drug|Beta-Carotene|
12086013|NCT00000161|Drug|Vitamin C|
12086014|NCT00000161|Drug|Vitamin E|
12086015|NCT00000160|Procedure|Xenon Photocoagulation|
12086016|NCT00000160|Procedure|Argon Photocoagulation|
12086017|NCT00000160|Procedure|Photocoagulation|
12086018|NCT00000159|Drug|Sorbinil|
12086019|NCT00000158|Procedure|Argon Blue-Green Laser Photocoagulation|
12086020|NCT00000157|Drug|Aspirin|
12086021|NCT00000156|Device|Goggles|
12086022|NCT00000156|Procedure|Ambient Light Reduction|
12086023|NCT00000154|Procedure|Vitrectomy|
12086024|NCT00000153|Procedure|Blue-Green Argon Laser Treatment|
12086025|NCT00000153|Procedure|Red Krypton Laser Treatment|
12086026|NCT00000152|Drug|Aspirin|
12086027|NCT00000152|Drug|Beta-Carotene|
12086028|NCT00000151|Drug|Aspirin|
12086029|NCT00000151|Procedure|Argon Laser Photocoagulation|
12086030|NCT00000150|Procedure|Subfoveal Choroidal Neovascularization Removal|
12086031|NCT00000149|Drug|Beta Blocker|
12086032|NCT00000149|Procedure|Trabeculectomy|
12086033|NCT00000149|Procedure|Argon Laser Trabeculoplasty|
12086034|NCT00000148|Procedure|Argon Laser Trabeculoplasty|
12086035|NCT00000148|Procedure|Trabeculectomy|
12086036|NCT00000147|Drug|Methylprednisolone|
12086037|NCT00000147|Drug|Prednisone|
12086038|NCT00000146|Drug|Methylprednisolone|
12086039|NCT00000146|Drug|Prednisone|
12086040|NCT00000145|Dietary Supplement|Antioxidants|500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene
12086041|NCT00000145|Dietary Supplement|Zinc|80 milligrams zinc oxide; 2 milligrams of cupric oxide
12086042|NCT00000145|Dietary Supplement|Antioxidants and zinc|500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide
12086043|NCT00000144|Procedure|Argon Laser Treatment|
12086044|NCT00000143|Device|Ganciclovir implant and oral ganciclovir|oral ganciclovir, 1 gm three times daily
12086045|NCT00000143|Drug|Cidofovir intravenous|intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
12086142|NCT00000308|Drug|Dextroamphetamine|15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
12086046|NCT00000142|Drug|Cidofovir|"Three groups:
~the deferral group, treatment deferred until retinitis progressed
~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
12086047|NCT00000140|Drug|Perfluoropropane|
12086048|NCT00000140|Drug|Sulfur Hexafluoride|
12086049|NCT00000140|Drug|Silicone Oil|
12086050|NCT00000139|Behavioral|Stress|
12086051|NCT00000139|Drug|Acyclovir|
12086052|NCT00000138|Drug|Prednisolone Phosphate|
12086053|NCT00000138|Drug|Acyclovir|
12086054|NCT00000137|Procedure|Histocompatibility Matching|
12086055|NCT00000136|Drug|Foscarnet|60 mg/kg every 8 hours, 90 mg/kg/day
12086056|NCT00000136|Drug|Ganciclovir|5 mg/kg every 12 hours, 5 mg/kg every 24 hours
12086057|NCT00000135|Drug|MSL-109|60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
12086058|NCT00000135|Other|Placebo|60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
12086059|NCT00000134|Drug|Ganciclovir|intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
12086060|NCT00000134|Drug|Foscarnet|intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
12086061|NCT00000133|Procedure|Trans-scleral Cryotherapy|
12086062|NCT00000132|Drug|Betaxolol|
12086063|NCT00000132|Procedure|Argon Laser Trabeculoplasty|
12086064|NCT00000131|Procedure|Photocoagulation Therapy|
12086065|NCT00000130|Drug|Intravitreal Antibiotics|
12086066|NCT00000130|Procedure|Initial Pars Plana Vitrectomy|
12086067|NCT00000129|Procedure|Radial Keratotomy|
12086068|NCT00000128|Device|Bifocal Spectacle Lenses|
12086069|NCT00000127|Procedure|Optic Nerve Sheath Decompression Surgery|
12086070|NCT00000126|Procedure|Surgery|
12086071|NCT00000125|Drug|Topical ocular hypotensive eye drops.|Topical ocular hypotensive eye drops.
12086072|NCT00000124|Procedure|Brachytherapy|
12086073|NCT00000124|Procedure|Eye Removal|
12086074|NCT00000123|Device|Polymethyl Methacrylate-Silicone Contact Lenses|
12086075|NCT00000123|Device|Polymethyl Methacrylate Contact Lenses|
12086076|NCT00000122|Drug|5-Fluorouracil|
12086077|NCT00000121|Device|Prisms in Eyeglasses|
12086078|NCT00000120|Drug|Erythromycin Ointment|
12086079|NCT00000120|Drug|Silver Nitrate Drops|
12086080|NCT00000119|Device|Heparin Surface-Modified Intraocular Lens|
12086081|NCT00000118|Device|Sustained-Release Intraocular Drug Delivery System|
12086082|NCT00000117|Drug|Immunoglobulin|
12086083|NCT00000116|Drug|Vitamin A|
12086084|NCT00000116|Drug|Nutritional Supplement|
12086085|NCT00000115|Drug|Acetazolamide|
12086086|NCT00000114|Drug|Vitamin E|
12086087|NCT00000114|Drug|Vitamin A|
12086088|NCT00000113|Other|Progressive Addition Lenses|Varilux comfort with +2.00 addition
12086089|NCT00000113|Other|single vision lenses|
12086090|NCT00000358|Drug|Lofexidine|
12086091|NCT00000357|Drug|Buprenorphine|
12086092|NCT00000356|Drug|LAAM|
12086093|NCT00000355|Drug|Buprenorphine|
12086094|NCT00000354|Drug|Lofexidine|
12086095|NCT00000353|Drug|Buprenorphine/naloxone|
12086096|NCT00000352|Drug|Dextromethorphan|
12086097|NCT00000350|Procedure|radioactive substance|
12086098|NCT00000349|Drug|Flupenthixol|
12086099|NCT00000348|Drug|Dihydrexidine|
12086100|NCT00000347|Drug|Risperidone|
12086101|NCT00000346|Behavioral|counseling|
12086102|NCT00000345|Drug|Lofexidine|
12086103|NCT00000344|Drug|Buprenorphine/naloxone|
12086104|NCT00000343|Behavioral|counseling|
12086105|NCT00000342|Drug|Risperidone|
12086106|NCT00000341|Drug|Buprenorphine|
12086107|NCT00000340|Drug|Pemoline|
12086108|NCT00000339|Drug|Risperidone|
12086109|NCT00000338|Drug|Lisuride|
12086110|NCT00000337|Drug|Selegiline|
12086111|NCT00000336|Drug|Selegiline|
12086112|NCT00000335|Drug|Morphine|
12086113|NCT00000334|Drug|Buprenorphine|
12086114|NCT00000333|Drug|Benztropine|
12086115|NCT00000332|Drug|Nimodipine|
12086116|NCT00000331|Drug|Test Drug|
12086117|NCT00000331|Drug|Placebo Drug|
12086118|NCT00000330|Drug|Opioid-Related Disorders|
12086119|NCT00000329|Drug|Opioid-Related Disorders|
12086120|NCT00000328|Drug|Opioid-Related Disorders|
12086121|NCT00000327|Drug|Heroin Dependence|
12086122|NCT00000326|Drug|Heroin Dependence|
12086123|NCT00000325|Behavioral|Gonadorelin|
12086124|NCT00000324|Drug|Tryptophan|
12086125|NCT00000322|Behavioral|Tyrosine|
12086126|NCT00000321|Drug|Desipramine|
12086127|NCT00000320|Drug|Buprenorphine formulation: liquid vs. tablet|random assignment to liquid buprenorphine or tablet buprenorphine
12086128|NCT00000319|Drug|Buprenorphine|
12086129|NCT00000318|Drug|Buprenorphine|"Experimental Maintenance treatment with daily medication
~Experimental Maintenance treatment with thrice-weekly medication"
12086130|NCT00000317|Drug|Risperidone|Risperidone (4mg/day)
12086131|NCT00000317|Drug|Placebo|Placebo
12086132|NCT00000317|Behavioral|Relapse prevention counseling|Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.
12086133|NCT00000316|Drug|Cocaine|
12086134|NCT00000315|Drug|Cocaine|
12086135|NCT00000314|Drug|M-CPP|
12086136|NCT00000313|Drug|Fenfluramine|
12086137|NCT00000312|Drug|M-CPP|
12086138|NCT00000311|Drug|Buprenorphine|Medication and Behavioral
12086139|NCT00000311|Drug|methadone|medication and behavioral
12086140|NCT00000310|Drug|Risperidone|
12086141|NCT00000309|Drug|Risperidone|
12086143|NCT00000308|Drug|D-amphetamine|15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
12086144|NCT00000308|Drug|placebo|placebo
12086145|NCT00000307|Drug|Naltrexone|
12086146|NCT00000306|Drug|Dextroamphetamine|
12086147|NCT00000305|Drug|Dextroamphetamine|
12086148|NCT00000304|Drug|Dextroamphetamine|15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
12086149|NCT00000304|Drug|D-Amphetamine|30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total)
12086150|NCT00000304|Drug|Placebo|Placebo
12086151|NCT00000303|Drug|Baclofen|
12086152|NCT00000302|Drug|Buprenorphine|
12086153|NCT00000301|Drug|Amantadine|
12086154|NCT00000300|Drug|LAAM|
12086155|NCT00000299|Drug|Buprenorphine|
12086156|NCT00000298|Drug|Buprenorphine/naloxone|
12086157|NCT00000297|Drug|Labetalol|
12086158|NCT00000296|Drug|Cotinine fumarate|
12086159|NCT00000295|Drug|Micronized Progesterone|
12086160|NCT00000294|Drug|Carvedilol|
12086161|NCT00000293|Drug|Nefazodone|
12086162|NCT00000292|Procedure|Cocaine|
12086163|NCT00000291|Drug|Labetalol|
12086164|NCT00000290|Drug|Cocaine|
12086165|NCT00000289|Drug|Ondansetron|
12086166|NCT00000288|Drug|Cotinine fumarate|
12086167|NCT00000286|Drug|Nefazodone|
12086168|NCT00000285|Drug|Phenytoin|
12086169|NCT00000284|Drug|Cotinine fumarate|
12086170|NCT00000282|Drug|Pemoline|
12086171|NCT00000281|Behavioral|Amantadine|
12086172|NCT00000280|Drug|Nimodipine|
12086173|NCT00000279|Drug|Clonidine|
12086174|NCT00000278|Drug|Disulfiram|
12086175|NCT00000277|Drug|Mazindol|
12086176|NCT00000276|Drug|Bupropion|
12086177|NCT00000275|Drug|Flupenthixol|
12086178|NCT00000274|Drug|Flupenthixol|
12086179|NCT00000273|Drug|opiates|prescription opioids
12086180|NCT00000271|Drug|Desipramine|Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
12086181|NCT00000271|Drug|Placebo|Participants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
12086182|NCT00000270|Drug|Cocaine|
12086183|NCT00000269|Drug|Pergolide|
12086184|NCT00000268|Drug|Bupropion|
12086185|NCT00000267|Drug|Risperidone|
12086186|NCT00000266|Drug|Flupenthixol|
12086187|NCT00000264|Drug|30% Nitrous oxide|
12086188|NCT00000264|Other|0.35 g/Kg ethanol|
12086189|NCT00000264|Other|0.7 g/Kg ethanol|
12086190|NCT00000264|Other|0 g/Kg ethanol|
12086191|NCT00000263|Drug|30% Nitrous oxide|
12086192|NCT00000263|Other|0.25 g/Kg ethanol|
12086193|NCT00000263|Other|0.5 g/KG ethanol|
12086194|NCT00000263|Other|0 g/Kg ethanol|
12086195|NCT00000262|Drug|30% Nitrous oxide|
12086196|NCT00000262|Drug|0.4% Sevoflurane|
12086197|NCT00000262|Drug|0.2% sevoflurane|
12086198|NCT00000262|Other|Placebo|
12086199|NCT00000261|Drug|30% Nitrous oxide|
12086200|NCT00000261|Other|Placebo|No drug (100% oxygen)
12086201|NCT00000261|Drug|0.2% sevoflurane|
12086202|NCT00000261|Drug|0.4% sevoflurane|
12086203|NCT00000261|Drug|0.6% sevoflurane|
12086204|NCT00000260|Drug|Nitrous oxide|
12086205|NCT00000259|Drug|15 % Nitrous oxide|
12086206|NCT00000259|Drug|0.3 % Sevoflurane|
12086207|NCT00000259|Drug|30% Nitrous oxide|
12086208|NCT00000259|Drug|0.6% Sevoflurane|
12086209|NCT00000259|Other|Placebo|
12086210|NCT00000258|Drug|Nitrous oxide 10% & placebo|
12086211|NCT00000258|Drug|Nitrous oxide 20% & placebo|
12086212|NCT00000258|Drug|Nitrous oxide 30% & placebo|
12086213|NCT00000258|Drug|Nitrous oxide 40% and placebo|
12086214|NCT00000257|Drug|0% N2O and 10% N2O|
12086215|NCT00000257|Drug|0% N2O and 20% N2O|
12086216|NCT00000257|Drug|0% N2O and 30% N2O|
12086217|NCT00000257|Drug|0% N2O and 40% N2O|
12086218|NCT00000256|Drug|20% N2O|
12086219|NCT00000256|Drug|40% N2O|
12086220|NCT00000256|Drug|60% N2O|
12086221|NCT00000256|Drug|80% N2O|
12086222|NCT00000255|Drug|Nitrous oxide|
12086223|NCT00000254|Drug|40% Nitrous oxide|Used as pain assay positive control
12086224|NCT00000254|Other|Sham comparator|0% isoflurane in oxygen
12086225|NCT00000254|Drug|0.2% isoflurane|
12086226|NCT00000254|Drug|0.4% isoflurane|
12086227|NCT00000254|Drug|0.6% isoflurane|
12086228|NCT00000253|Drug|10% N2O|
12086229|NCT00000253|Drug|20% N2O|
12086230|NCT00000253|Drug|30% N2O|
12086231|NCT00000253|Drug|40% N2O|
12086232|NCT00000252|Drug|0% N2O|
12086233|NCT00000252|Drug|10% N2O|
12086234|NCT00000252|Drug|20% N2O|
12086235|NCT00000252|Drug|30% N2O|
12086236|NCT00000252|Drug|40% N2O|
12086237|NCT00000251|Drug|30% N2O|
12086238|NCT00000251|Drug|0.2% isoflurane|
12086239|NCT00000251|Drug|0.4% isoflurane|
12086240|NCT00000251|Other|100% oxygen|Placebo
12086241|NCT00000250|Drug|0% N2O|Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water
12086242|NCT00000250|Drug|40% N2O|Subjects will inhale 40% N2O then immerse forearm in warm water and cold water
12086243|NCT00000249|Drug|20% N2O|20% inhaled N2O
12086244|NCT00000249|Drug|30% N2O|30% inhaled N2O
12086245|NCT00000249|Drug|40% N2O|40% inhaled N2O
12086246|NCT00000248|Drug|Pergolide|
12086247|NCT00000246|Drug|Flumazenil|
12086248|NCT00000245|Drug|Desipramine|
12086249|NCT00000244|Drug|Dynorphin 1 - 13|
12086250|NCT00000243|Drug|Buprenorphine|
12086251|NCT00000242|Drug|Carbamazepine|
12086252|NCT00000241|Drug|Flupenthixol|
12086253|NCT00000240|Drug|Buprenorphine|
12086257|NCT00000236|Drug|Buprenorphine/naloxone|
12086258|NCT00000235|Drug|Buprenorphine|
12086259|NCT00000234|Drug|Buprenorphine|
12086260|NCT00000233|Drug|Buprenorphine|
12086261|NCT00000232|Drug|Buprenorphine|
12086262|NCT00000231|Drug|Buprenorphine|
12086263|NCT00000230|Drug|Buprenorphine|
12086264|NCT00000229|Drug|Buprenorphine|
12086265|NCT00000228|Drug|Buprenorphine|
12086266|NCT00000227|Drug|Buprenorphine|
12086267|NCT00000226|Drug|Buprenorphine|
12086268|NCT00000225|Drug|Buprenorphine|
12086269|NCT00000224|Drug|Buprenorphine|
12086270|NCT00000223|Drug|Buprenorphine|
12086271|NCT00000222|Drug|Buprenorphine|
12086272|NCT00000221|Drug|Buprenorphine|
12086273|NCT00000220|Drug|Buprenorphine|
12086274|NCT00000219|Drug|Buprenorphine|
12086275|NCT00000218|Drug|Carbamazepine|
12086276|NCT00000217|Drug|Carbamazepine|
12086277|NCT00000216|Drug|Buprenorphine|
12086278|NCT00000215|Drug|Pergolide|
12086279|NCT00000214|Drug|Buprenorphine|
12086280|NCT00000213|Drug|Fluoxetine|
12086281|NCT00000212|Drug|Desipramine|
12086282|NCT00000211|Drug|Buprenorphine|
12086283|NCT00000210|Drug|Buprenorphine|
12086284|NCT00000209|Drug|Buprenorphine|
12086285|NCT00000208|Drug|Buprenorphine|
12086286|NCT00000207|Drug|Buprenorphine|
12086287|NCT00000206|Drug|Buprenorphine|
12086288|NCT00000205|Drug|Buprenorphine|
12086289|NCT00000204|Drug|Buprenorphine|
12086290|NCT00000203|Drug|Buprenorphine|
12086291|NCT00000202|Drug|Buprenorphine|
12086292|NCT00000201|Drug|Selegiline|
12086293|NCT00000200|Drug|Methadone|normal maintenance dose
12086294|NCT00000199|Drug|Piracetam|
12086295|NCT00000198|Drug|Piracetam|
12086296|NCT00000197|Drug|Propranolol|
12086297|NCT00000196|Drug|Naltrexone|
12086298|NCT00000195|Drug|Naltrexone|
12086299|NCT00000194|Drug|Cycloserine|
12086300|NCT00000193|Drug|Gamma hydroxybutyric|
12086301|NCT00000192|Drug|Lamotrigine|
12086302|NCT00000191|Drug|Carbamazepine|
12086303|NCT00000190|Procedure|Parotid Gland|
12086304|NCT00000189|Drug|Gepirone|
12086305|NCT00000188|Drug|Selegiline|
12086306|NCT00000187|Drug|Ritanserin|
12086307|NCT00004640|Drug|Chlorhexidine rinse|chlorhexidine solution on tooth loss in low income
12086308|NCT00004639|Procedure|Furlow double z-plasty palatoplasty palate repair|
12086309|NCT00004639|Procedure|Von Langenbeck palatoplasty palate repair|
